Guidance for navigation and positioning of intravascular delivery devices

Abstract

Techniques are provided for guiding the navigation and positioning of intravascular delivery devices. A medical navigation system includes a delivery device comprising a catheter, an intravascular delivery device configured to be releasably positioned within the catheter for placement at a target site in a patient, and a navigation computer system. The intravascular delivery device includes multiple electrodes, including at least one indicator electrode and at least one reference electrode, configured not to come into contact with tissue when the intravascular delivery device is deployed at the target site. The navigation computer system is configured to be electrically coupled to the multiple electrodes. The navigation computer system controls a drive source to transmit current to the multiple electrodes, collects electrode data corresponding to the multiple electrodes, monitors the impedance corresponding to the indicator electrode, and determines when the indicator electrode has come into contact with tissue.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of the filing date of European Patent Application No. EP23386019.6, filed on March 9, 2023, the disclosure of which is incorporated herein by reference.

[0002] The present disclosure generally relates to the delivery, positioning, and / or deployment of intravascular delivery devices. More particularly, the embodiments described herein relate to systems, devices, and methods for providing guidance for cardiovascular imaging during intravascular procedures.

Background Art

[0003] The left atrial appendage (LAA) is a muscular pouch that extends from the anterior - lateral wall of the left atrium of the heart. The LAA serves as a reservoir for the left atrium. During a normal cardiac cycle, the LAA contracts with the left atrium to pump blood into the left ventricle. This atrial contraction generally prevents blood from pooling within the LAA. However, during a cardiac cycle with an arrhythmia (e.g., atrial fibrillation), the LAA may not be able to contract sufficiently. As a result, blood may pool within the LAA. Blood that pools within the LAA is prone to clotting and forming thrombi, which can be pushed out of the LAA and ultimately lead to embolic stroke.

[0004] Atrial fibrillation is one of the most common arrhythmias, affecting more than 35 million people worldwide. The main risk associated with atrial fibrillation is stroke caused by thrombi formed within the ventricles. The first - line treatment for thrombi remains anticoagulants. However, long - term oral anticoagulation is contraindicated for some patients.

[0005] Another treatment is closure of the left atrial appendage. Typically, LAA occlusion is performed via a transseptal approach requiring both fluoroscopy and direct intravenous injection of an iodine-based contrast agent into the left atrium. Under fluoroscopy, the injection of contrast agent is usually required to assess the geometry of the LAA, ensure proper positioning of the LAA occlusion device, and verify that LAA occlusion has been achieved. However, contrast agents can have nephrotoxicity, which is harmful to the kidneys. Furthermore, the X-rays used in fluoroscopy carry potential harm to both the patient exposed to the X-rays and the operating room staff.

[0006] Therefore, it is useful to reduce reliance on fluoroscopy, including contrast-enhanced fluoroscopy, during endovascular procedures, including LAA occlusion. [Overview of the project]

[0007] The attached claims may serve as a summary. [Brief explanation of the drawing]

[0008] [Figure 1] This is a schematic cross-section of a human heart illustrating exemplary transapical delivery approaches and exemplary transseptal delivery approaches. [Figure 2] This is a schematic diagram of the mitral valve, left atrial appendage, and associated structures during normal cardiac function. [Figure 3A-3C] This is a diagram illustrating an exemplary LAA occlusion device. [Figure 4A] This figure shows an exemplary delivery device. [Figure 4B] This figure shows an exemplary delivery device. [Figure 5] This is a schematic diagram of an example medical navigation system. [Figures 6A-6F] This diagram shows the stages of an exemplary LAA occlusion procedure. [Figure 7A] This figure shows an exemplary set of electrodes placed on the surface of an exemplary LAA occlusion device and corresponding exemplary impedance data. [Figure 7B]This figure shows an exemplary set of electrodes placed on the surface of an exemplary LAA occlusion device and corresponding exemplary impedance data. [Figure 7C] This figure shows an exemplary set of electrodes placed on the surface of an exemplary LAA occlusion device and corresponding exemplary impedance data. [Figure 7D] This figure shows an exemplary set of electrodes placed on the surface of an exemplary LAA occlusion device and corresponding exemplary impedance data. [Figure 8] This is a block diagram showing a computer system that can implement one or more examples. [Modes for carrying out the invention]

[0009] The following description includes numerous specific details to provide a full understanding of this disclosure. However, it will be apparent that these embodiments can be implemented without these specific details. The following detailed description describes exemplary embodiments, and the features disclosed are not intended to be limited to the combinations expressly disclosed. Therefore, unless otherwise stated, the features disclosed herein can be combined to form additional combinations not shown separately for the sake of brevity.

[0010] In this specification, the term “proximal” refers, when used in relation to a delivery device or a component of a delivery device, to the end of the device closer to the user when the device is being used as intended. Conversely, the term “distal” refers, when used in relation to a delivery device or a component of a delivery device, to the end of the device further from the user when the device is being used as intended. In some cases, the terms “proximal” and “distal” may be arbitrarily assigned to facilitate understanding of this disclosure, and such cases will be readily apparent to those skilled in the art. In this specification, the terms “substantially,” “generally,” “approximately,” and “about” are intended to mean that the scope of the terms thus modified includes a slight deviation from the absolute.

[0011] The term "or" may be inclusive or exclusive unless otherwise explicitly stated; the term "set" may include zero, one, two, or more elements; the terms "first," "second," "certain," and "particular" are used as naming conventions to distinguish elements from one another and, unless otherwise specified, do not imply the order, timing, or any other characteristics of the items being referenced; the term "and / or" as used herein refers to and encompasses one or more possible combinations of the related enumerated items; and the terms "comprises" and / or "comprising" specify the presence of the described feature but do not exclude the presence or addition of one or more other features.

[0012] "Computer system" means one or more computers, such as one or more physical computers, virtual computers, and / or computing devices. For example, a computer system may be, or may include, one or more server computers, desktop computers, laptop computers, mobile devices, special-purpose computing devices with processors, cloud-based computers, cloud-based computer clusters, virtual machine instances, and / or other computing devices. A computer system may include other computer systems, and one computing device may belong to two or more computer systems. Unless otherwise expressly stated, a reference to "computer system" may mean one or more computers. When a computer system performs an operation, that operation is performed by one or more computers in the computer system.

[0013] A “computing device” can be a computer system, hardware and / or software stored or combined in memory, and / or one or more processors on one or more computers. Alternatively or additionally, a computing device may comprise special circuits. For example, a computing device may be hardwired or persistently programmed to correspond to a set of instructions in order to perform the functions discussed herein. A computing device may be a standalone component, may function with one or more other computing devices, may include one or more other computing devices, and / or may belong to one or more other computing devices.

[0014] A “component” can be hardware and / or software stored in or coupled to memory, and / or one or more processors on one or more computers. Alternatively or additionally, a component may comprise special circuitry. For example, a component can be hardwired and / or continuously programmed by a set of instructions to perform the functions discussed herein. A component can be a standalone component, can function with one or more other components, can include one or more other components, and / or belong to one or more other components.

[0015] This disclosure covers one and / or more intravascular delivery devices, systems, and methods for the delivery, positioning, and / or deployment of intravascular delivery devices. Throughout this disclosure, many examples are described in the context of LAA occlusion devices. However, it will be understood by those skilled in the art that the components, features, and principles described may also be applicable in other fields of application. For example, at least some of the embodiments described herein may be used for the delivery, positioning, and / or deployment of prosthetic valves replacing pulmonary valves, aortic valves, or tricuspid valves. Furthermore, it will be understood that at least some of the embodiments described herein may be used in conjunction with other intravascular delivery devices, including occlusion devices, valve repair devices, annuloplasty devices, clip devices, and other intravascular delivery devices that are not necessarily configured as LAA occlusion devices. Regardless of such alternative fields of application, the preferred embodiments described herein are configured to address in particular the challenges associated with the delivery, positioning, and deployment of LAA occlusion devices. Thus, the embodiments described below are particularly useful for addressing the additional procedural challenges associated with LAA occlusion by an intravascular approach.

[0016] One aspect of the present disclosure relates to a medical navigation system for intravascular procedures, the medical navigation system comprising: a delivery device comprising a catheter; an intravascular delivery device configured to be releasably positioned within the catheter for deployment at a target site in a patient, comprising a plurality of electrodes, the plurality of electrodes including at least one indicator electrode and at least one reference electrode configured so as not to contact tissue when the intravascular delivery device is deployed at a target site; and a navigation computer system configured to be electrically coupled to the plurality of electrodes, comprising one or more processors and at least one memory for storing instructions, wherein when an instruction is executed by one or more processors, the navigation computer system causes one or more processors to control a drive source to transmit current to the plurality of electrodes, to collect electrode data corresponding to the plurality of electrodes, to monitor the impedance corresponding to at least one indicator electrode based on the electrode data, and to determine, based on the electrode data, that at least one indicator electrode has made contact with tissue.

[0017] In some examples, the intravascular delivery device is an LAA occlusion device, the target site is the patient's LAA, and the tissue is the LAA wall. Alternatively or additionally, the LAA occlusion device includes a disc at the proximal end of the LAA occlusion device, with at least one indicator electrode positioned on the edge surface of the disc. Alternatively or additionally, multiple electrodes are positioned on the edge surface of the disc, including at least two indicator electrodes spaced substantially uniformly around the edge surface. Alternatively or additionally, the LAA occlusion device includes a lobe at the distal end of the LAA occlusion device, with at least one indicator electrode positioned on the side of the lobe. Alternatively or additionally, at least one electrode is positioned on the distal edge of the side of the lobe. Alternatively or additionally, at least one electrode is positioned on the proximal edge of the side of the lobe. Alternatively or additionally, at least one electrode is positioned between the distal and proximal edges of the side of the lobe.

[0018] In some examples, at least one sense electrode includes a first sense electrode that is expected to contact tissue when the intravascular delivery device is deployed at the target site.

[0019] In some examples, when executed by one or more processors, the instructions cause the one or more processors to evaluate a degree of contact between at least one sense electrode and tissue based on electrode data corresponding to at least one reference electrode and at least one sense electrode.

[0020] In some examples, evaluating the degree of contact between at least one sense electrode and tissue includes subtracting an electrode signal corresponding to at least one reference electrode from an electrode signal corresponding to at least one sense electrode and analyzing an amplitude of the resulting signal.

[0021] In some examples, at least one sense electrode includes a second sense electrode that is not expected to contact tissue when the intravascular delivery device is deployed at the target site. Alternatively or additionally, when executed by one or more processors, the instructions cause the one or more processors to generate a warning notification when the second sense electrode contacts tissue.

[0022] In some examples, at least one sense electrode includes a third sense electrode that is not expected to contact tissue when the intravascular delivery device is deployed at the target site, and the third sense electrode is disposed at a distal tip of the LAA occlusion device.

[0023] In some examples, the navigation computer system monitors an impedance corresponding to at least one sense electrode based on electrode data generated based on three pairs of electrodes disposed on a patient's surface during an intravascular procedure.

[0024] In some examples, when an instruction is executed by one or more processors, it causes one or more processors to determine the position and orientation of an intravascular delivery device based on electrode data corresponding to multiple electrodes, and to display a depiction of the intravascular delivery device against a depiction of the patient's anatomical structure on a display communicatively coupled to a navigation computer system. Alternatively or additionally, the depiction of the patient's anatomical structure is based on a 3D model of the patient's anatomical structure generated before the intravascular procedure.

[0025] In some examples, the catheter is a maneuverable catheter, comprising a second set of electrodes positioned at the distal end of the maneuverable catheter, and when a command is executed by one or more processors, it causes one or more processors to determine the location of each of the electrodes, determine the configuration and location of the distal end of the maneuverable catheter, and display a representation of the distal end of the maneuverable catheter device relative to the patient's anatomical structure on a display communicatively coupled to a navigation computer system.

[0026] In some implementations, the various techniques described herein can achieve one or more of the following advantages: increased procedural safety of endovascular procedures such as LAA occlusion; reduced and / or elimination of the use of fluoroscopy and / or contrast injection; the ability to position the intravascular delivery device and / or delivery device to facilitate navigation for deployment and / or positioning; the ability to quantify the pressure acting on tissue by the intravascular delivery device, such as the pressure acting on the LAA wall by the LAA occlusion device, while positioning the intravascular delivery device; and the ability for electrode data to provide a standardized criterion for quantifying satisfactory deployment of the intravascular delivery device. Additional features and advantages are evident from this specification and the drawings.

[0027] Overall Overview This disclosure aims to provide, but is not limited to, systems, devices, device modifications, and / or methods for navigating a patient's vascular network and / or ventricles for performing a diagnosis and / or delivering an intravascular delivery device, such as a guidewire, delivery sheath, closure device, valve repair device, valve replacement device, and / or other intravascular delivery device. The techniques described herein can be used to reduce and / or eliminate the use of fluoroscopy and / or contrast media (including iodine-based contrast media) and to collect additional physiological data during the procedure.

[0028] Intravascular delivery devices, such as LAA occlusion devices, include multiple electrodes positioned on the surface of the intravascular delivery device. A medical navigation system can use these multiple electrodes to determine the position and / or state of the intravascular delivery device during navigation of a vascular structure to a target site, such as an LAA. The medical navigation system can use these multiple electrodes to assess contact between the intravascular delivery device and the tissue of the target site, such as the wall of an LAA. The delivery device may include a second set of electrodes positioned on the surface of its distal end. The medical navigation system can use these multiple electrodes to determine the position and / or state of the distal end of the delivery device during navigation of a vascular structure to a target site.

[0029] Figure 1 is a schematic cross-section of a human heart 100. The human heart contains two atria and two ventricles, namely the right atrium 112 and the left atrium 122, as well as the right ventricle 114 and the left ventricle 124. The heart 100 further includes the aorta 110 and the aortic arch 120. The mitral valve 130 is located between the left atrium 122 and the left ventricle 124. The mitral valve 130, also known as the bicuspid valve or left atrioventricular valve, is a valve with two flaps that open when the pressure in the left atrium 122 increases compared to the left ventricle 124. After the left atrium 122 has filled and begun to contract, when the pressure in the left atrium 122 exceeds the pressure in the left ventricle 124, the mitral valve 130 opens and blood flows towards the left ventricle 124. Blood typically flows through the heart 100 in the anterograde direction, indicated by arrow "B". LAA160 is located adjacent to mitral valve 130 and opens to left atrium 122.

[0030] The dashed arrows labeled TA indicate exemplary transapical approaches for the treatment or replacement of cardiac tissue. In transapical delivery of an LAA occlusion device (e.g., LAA occlusion device 30) to LAA160, a small incision is made between folds within the apex of the left ventricle 124 at position P1 in the cardiac wall 150 to deliver the LAA occlusion device 30 to LAA160. The alternative route indicated by the second dashed arrow labeled TS indicates an exemplary transseptal approach, in which an incision is made through the atrial septum 152 of the heart 100 from the right atrium 112 to the left atrium 122 at position P2. In the transseptal approach, the delivery system can enter the patient's body via the jugular vein (not shown), proceed into the right atrium 112 via the superior vena cava (shown in Figure 1 but not labeled), perforate the atrial septum 152 to enter the left atrium 122, and approach LAA160. More typically, in a transseptal approach, the delivery system can enter the patient's body via the femoral vein (not shown) and proceed into the right atrium 112 via the inferior vena cava (shown in Figure 1 but not labeled), and the procedure from there is generally the same as described above for the superior vena cava approach.

[0031] Figure 2 is a more detailed schematic diagram of the left atrium 122 and left ventricle 124, showing the LAA160 in more detail. During normal function, the LAA160 contracts rhythmically with the left atrium 122, and blood from the LAA160 is released into the left atrium and then enters the left ventricle 124 through the mitral valve 130. With each cycle, the blood in the LAA160 is completely emptied, and the mitral valve 130 prevents backflow from the left ventricle 124 to the left atrium 122.

[0032] In some patients (for example, elderly patients), the right atrium 112 and left atrium 122 of the heart may not beat regularly; this condition is known as atrial fibrillation. In some cases, this can result in partial or incomplete release of blood from the LAA 160. Blood retained in the LAA 160 can form a thrombus, which can eventually travel to the brain and cause a stroke. To prevent retained blood from clotting in the LAA 160, an LAA occlusion device can be inserted as a plug in the cavity of the LAA 160.

[0033] Exemplary LAA occlusion device Figure 3A shows an exemplary LAA occlusion device 30. In LAA occlusion procedures, the LAA occlusion device 30 is placed within the LAA 160 to reduce the risk of stroke due to atrial fibrillation. The LAA occlusion device 30 includes a disc 34 located at the proximal end 38 of the LAA occlusion device 30 and a lobe 32 located at the distal end 36 of the LAA occlusion device 30. The lobe 32 is shaped and sized to fit snugly within the LAA 160 when fully expanded, and the disc 34 is shaped and sized to cover the opening (or mouth) leading into the LAA 160 when fully expanded. That is, it is preferable that the outer diameter of the lobe 32 is larger than the inner diameter of the LAA 160 when fully expanded so that the lobe 32 is held in place by friction within the LAA 160. Similarly, it is preferable that the outer diameter of the disc 34 is larger than the inner diameter of the mouth of the LAA 160 when fully expanded so that the disc 34 completely covers the opening leading into the LAA 160. The lobes 32 and discs 34 can be formed from a mesh containing multiple twisted yarns, at least one of which may be a metallic twisted yarn. The twisted yarns can be knitted, woven, or otherwise combined to define a substantially tubular mesh. The illustrated embodiment shows the lobes 32 and discs 34 of the LAA occlusion device 30 in an enlarged state, but it is preferable that the LAA occlusion device 30 be formed from a shape memory material (e.g., a nickel-titanium alloy such as Nitinol) that is compressed within the delivery device and returns to its enlarged shape when released from the delivery device. A connecting element can connect the proximal end of the lobe 32 to the disc 34. The connecting element can be configured so that the lobes 32 and discs 34 are articulated, rotatable, or otherwise movable relative to and / or relative to the connecting element. The discs 34 and / or lobes 32 may contain one or more cloths or other materials within the knitted mesh, and these cloths or other materials can help promote internal tissue growth and / or sealing after implantation of the LAA occlusion device 30.

[0034] Multiple electrodes (for example, electrodes 48, 50, 52, 54, 56, 58, 60, 62) are positioned on the surface of the LAA occlusion device 30. Although eight electrodes are shown, the multiple electrodes 48-62 can include any number of electrodes. The electrodes are conductors used to establish electrical contact with non-metallic components of a circuit, such as cardiac tissue within the heart 100, and / or to carry current to such non-metallic components. A medical navigation system (for example, medical navigation system 5, see Figure 5) uses the multiple electrodes 48-62 to determine their positions and thus determines the position of the LAA occlusion device 30 based on electrode data collected from the multiple electrodes 48-62. As an addition or alternative, the medical navigation system may use the multiple electrodes 48-62 to evaluate contact between the LAA occlusion device 30 and cardiac tissue, such as the walls of the LAA 160.

[0035] Multiple electrodes 48-62 are configured to be electrically coupled to a drive source, such as a signal generator 25 of the medical navigation system 5 in Figure 5. In some embodiments, one or more wires (not shown) of the LAA occlusion device 30 electrically couple one or more of the multiple electrodes 48-62 to one or more wires (not shown) of a delivery device (e.g., delivery device 70). One or more wires of the delivery device can electrically couple the multiple electrodes 48-62 to the medical navigation system, which is configured to drive the electrodes 48-62 to collect electrode data from them. An exemplary medical navigation system is described in more detail below.

[0036] The plurality of electrodes 48-62 may include one or more electrodes 48-50 positioned on the distal surface of the LAA occlusion device 30. Alternatively or additionally, the plurality of electrodes 48-62 may include one or more electrodes 52-54 positioned on the edge surface of the disc 34 (e.g., the radially outer edge surface). Alternatively or additionally, the plurality of electrodes 48-62 may include one or more electrodes 56 positioned on the proximal surface of the LAA occlusion device 30. Alternatively or additionally, the plurality of electrodes 48-62 may include one or more electrodes 58-62 positioned on the side surface of the lobe 32 (e.g., the radially outer side surface). Alternatively or additionally, the plurality of electrodes 48-62 may include one or more other electrodes positioned on another surface of the LAA occlusion device 30. Figure 3B shows the proximal end of an exemplary LAA occlusion device 30 and includes an electrode 56 positioned on the proximal surface of the LAA occlusion device 30 at or near the radial center of the disc 34. Figure 3C shows the distal end of an exemplary LAA occlusion device 30. Electrode 48 is positioned at the distal tip of the LAA occlusion device 30, such as the distal screw or clamp 40 of the LAA occlusion device 30. Electrode 50 is positioned adjacent to the base of the distal screw or clamp 40.

[0037] The LAA occlusion device 30 may include one or more insulating barriers between one or more of the electrodes 48-62 and one or more metal components of the LAA occlusion device 30. Alternatively or additionally, one or more conductive elements of the LAA occlusion device 30 may function as one or more of the electrodes 48-62, for example, by electrically coupling the conductive elements to a drive source by isolated electrical wires. For example, one or more stabilizing wires of the LAA occlusion device 30 can be converted into electrodes. In some embodiments, a distal screw or clamp 40 positioned at or near the radial center of the distal surface of the LAA occlusion device 30 is converted into an electrode 48. Alternatively or additionally, an electrode 48 located approximately at the radial center of the distal surface of the LAA occlusion device 30 is positioned at or near the distal screw or clamp 40.

[0038] In some examples, multiple electrodes 48–62 include one or more reference electrodes. Reference electrodes, also called “indifferent electrodes,” have a stable and / or known electrode potential. Using data collected from the reference electrodes, and data collected from another electrode, typically called an indicator electrode, or even a recording electrode, accurate measurements can be obtained. The use of reference electrodes for analyzing electrode data is described in more detail below.

[0039] exemplary delivery device Figure 4A shows an exemplary delivery device 70. The exemplary delivery device 70 includes a handle 72 at the proximal end 68 of the exemplary delivery device 70. In some embodiments, the exemplary delivery device 70 is configured to deliver the LAA occlusion device 30 to the vicinity of the LAA 160 for deployment into the LAA 160. Additionally or alternatively, the delivery device 70 can be adapted to deliver any other intravascular delivery device. The exemplary delivery device 70 includes a catheter 74 extending between the distal end 66 of the exemplary delivery device 70 and the handle 72, with the handle 72 remaining outside the patient. In some embodiments, the catheter 74 is a maneuverable catheter and has a flexible, maneuverable catheter tip 76 at the distal end 66 of the delivery device 70. The catheter 74 has a lumen running throughout the entire catheter 74, thereby allowing the LAA occlusion device 30 to pass through the delivery device in a compressed configuration.

[0040] The lumen of the catheter 74 can further accommodate an internal rod, the end of which is located a plunger used to deploy the LAA occlusion device 30 by translating it distally from the catheter 74. Alternatively or additionally, the catheter 74 may include a delivery sheath, which is retracted to expose and deploy the LAA occlusion device 30. Alternatively or additionally, the delivery device 70 may include another structure for translating the LAA occlusion device 30 outward from the catheter 74, such as a magnet, a fastener, a rounded tip, or any other suitable mechanism. In some embodiments, the end of a push rod or wire is located at a threaded tip which is screwed to a threaded fastener located at the radial center of the proximal disc 34. In these embodiments, the push rod can be pushed into the delivery device to push the LAA occlusion device 30 through the delivery device, and the LAA occlusion device 30 can remain screw-connected to the push rod until the push rod is rotated to detach the threaded tip of the push rod from the threaded fastener of the LAA occlusion device 30. The catheter 74 can be formed from any known material for constructing the catheter, including biocompatible polymers and / or metals such as stainless steel. The LAA occlusion device 30 is housed in a compressed configuration within the lumen of the catheter 74 until it is deployed from the catheter 74. When the distal end 66 of the delivery device 70 is properly positioned relative to the LAA 160, the LAA occlusion device 30 can be pushed forward through the catheter 74.

[0041] Figure 4B shows the distal portion of the catheter 74, including the catheter tip 76. Multiple electrodes (for example, electrodes 80, 82, 84, 86, and 88) are positioned on the surface of the catheter tip 76. Although five electrodes 80–88 are shown, the multiple electrodes 80–88 can include two, three, four, six, or any number of electrodes. In some embodiments, one or more of the multiple electrodes 80–88 have a ring shape that circumscribes the catheter 74. The multiple electrodes 80–88 can be positioned uniformly spaced over the catheter tip 76, such as approximately 10 mm apart from each other.

[0042] A medical navigation system (for example, medical navigation system 5) uses a plurality of electrodes 80-88 to determine the location of each electrode in three dimensions. Based on the electrode locations, the medical navigation system can determine the position and / or configuration of the catheter tip 76 within the heart 100. In some embodiments, when the catheter tip 76 is maneuverable, the specific configuration of the maneuverable catheter tip 76 can be determined.

[0043] In some embodiments, one or more wires 78 of the delivery device 70 electrically couple one or more of a plurality of electrodes 80-88 to a drive source, such as a drive source controlled by a navigation computer system of a medical navigation system. In some embodiments, one or more wires 78 include separate wires connected to each of the plurality of electrodes 80-88. One or more wires of the delivery device 70 can electrically couple the plurality of electrodes 80-88 to a navigation computer system, which is configured to drive the electrodes and collect data from them. The lumen of the catheter 74 can accommodate one or more wires extending from a plurality of electrodes 80-88 at the distal end of the catheter 74 through the proximal end of the catheter 74, and such wires can also extend through at least a portion of the handle 72. As an addition or alternative, the lumen of the catheter 74 can accommodate one or more wires configured to electrically couple to a plurality of electrodes 48-62 of the LAA occlusion device 30. Such wires may extend from one or more electrical contacts at the distal end 66 of the delivery device 70 through the proximal end of the catheter 74 and further through at least a portion of the handle 72. In some embodiments, the wires may extend along the outer surface of the catheter 74 and / or through the walls of the catheter as an addition or alternative to extending through the lumen of the catheter 74. While the lumen of the catheter 74 has been described herein, the catheter may have one or more lumens, some of which may function as described herein. For example, the secondary lumen of the catheter 74 may accommodate one or more wires as described herein.

[0044] Exemplary medical navigation system Figure 5 is a schematic diagram of an exemplary medical navigation system. The medical navigation system 5 provides non-fluoroscopic navigation during endovascular procedures. The patient 11 is schematically depicted as an ellipse for clarity. When current is applied to the two surface electrodes of a pair of electrodes, a voltage gradient is generated along the axis between the electrodes. Three sets of surface or patch electrodes are shown along the Y-axis as the first pair of electrodes 18, 19, along the X-axis as the second pair of electrodes 12, 14, and along the Z-axis as the third pair of electrodes 16, 22. The X, Y, and Z axes form three orthogonal axes (XYZ). The patient 11 can be positioned so that the patient's heart 100 is generally located near the center between one or more pairs of electrodes. The patch electrode 16 is positioned on the front of the patient 11 closest to the reader viewing Figure 5, and the patch electrode 22 is shown in outline form to show its position on the back of the patient 11. The heart 100 of patient 11 is positioned between these various sets of patch electrodes 18, 19, 12, 14, 16, and 22. An additional patch electrode 21, which may also be called a "berry" patch, a "ground patch," or a "reference patch," is also shown. Each patch electrode 18, 19, 12, 14, 16, 22, and 21 is independently connected to a multiplex switch 24. During the endovascular procedure, patient 11 may have most or all of a conventional surface 12-lead electrocardiogram system (not shown) in place, and this electrocardiogram information can be made available to the navigation computer system 20.

[0045] Each patch electrode 18, 19, 12, 14, 16, 22, 21 is coupled to a switch 24, and electrode pairs (18, 19), (12, 14), and (16, 22) are selected by software running on a navigation computer system 20, and these electrodes 18, 19, 12, 14, 16, 22 are coupled to a signal generator 25. A pair of electrodes, for example electrodes 18 and 19, are excited by the signal generator 25, and these generate an electric field within the body of the patient 11, including the heart 100. During the delivery of the current pulse, the remaining patch electrodes 12, 14, 16, 22 are referred to the berry patch electrode 21, and the voltage applied to these remaining electrodes 12, 14, 16, 22 is measured. A suitable low-pass filter 27 or software processes the voltage measurement to remove electronic noise and cardiac motion artifacts from the measured signal. The filtered voltage measurements are converted into digital data by an analog-to-digital or AD converter 26. Other signal processing methods may be used as an addition or alternative. In this way, the various patch electrodes 18, 19, 12, 14, 16, and 22 are divided into driven and non-driven electrode sets. One pair of electrodes is driven by the signal generator 25, while the remaining non-driven electrodes are used as a reference for synthesizing the orthogonal driven axes.

[0046] The berry patch electrode 21 is shown in this figure as an alternative to a fixed intracardiac electrode. In many cases, a coronary sinus electrode or another fixed electrode within the heart 100 can be used as a reference for measuring voltage and displacement. All raw patch voltage data is measured by the AD converter 26 and stored in the navigation computer system 20 under the direction of the software. This electrode excitation process occurs rapidly and sequentially as sets of patch electrodes 18, 19, 12, 14, 16, and 22 are alternately selected, and the remaining members of the set are used to measure voltage. This group of voltage measurements may be referred to herein as a “patch dataset”. The software has access to each individual voltage measurement at each individual patch electrode 18, 19, 12, 14, 16, and 22 during the excitation of each pair of electrodes 18, 19, 12, 14, 16, and 22.

[0047] Raw patch data is used to determine the “raw” locations of electrodes within the heart 100 in three spatial dimensions (X, Y, Z), such as multiple electrodes 48-62 of the LAA occlusion device 30 and / or multiple electrodes 80-88 of the delivery device 70. This process is also called “triangulation.” Triangulation is the process of determining the location of a point by measuring the angles from several known points. The optical 3D measurement system uses a triangulation network to determine the spatial dimensions and geometry of an object. At least two outputs of the sensors are considered to be points on the surface of the object defining a spatial triangle. Within the boundaries of this triangle, the distance between the sensor and the base is known. By determining the angles between the sensor and the base, the intersection, and therefore the 3D coordinates, are calculated from the relationship of the triangle.

[0048] In some embodiments, the navigation computer system 20 controls the signal generator 25 to transmit electrical signals through each pair of electrodes (18, 19), (12, 14), and (16, 22) to generate voltage gradients along each of the three axes X, Y, and Z, thereby forming a transthoracic electric field. When the catheter 74 enters the transthoracic electric field, each catheter electrode 80-88 can sense the voltage in accordance with the generation of gradients along each axis. Using the electrode data collected from the catheter electrodes 80-88 and compared with the voltage gradients of all three axes, the navigation computer system 20 can calculate the three-dimensional position of one or more catheter electrodes 80-88. Alternatively or additionally, when the LAA occlusion device 30 enters the transthoracic electric field, each LAA occlusion device electrode 48-62 can sense the voltage in accordance with the generation of gradients along each axis. By comparing the voltage gradients of all three axes with electrode data collected from LAA occlusion device electrodes 48-62, the navigation computer system 20 can calculate the three-dimensional position of one or more LAA occlusion device electrodes 48-62. The calculated positions for one or more delivery device electrodes 80-88 and / or LAA occlusion device electrodes 48-62 can be determined simultaneously and periodically, such as multiple times per second.

[0049] In some embodiments, the calculated positions of one or more delivery device electrodes 80-88 can be used to determine the position and orientation of at least a portion of the delivery device 70, including, but not limited to, the catheter tip 76. Alternatively or additionally, the calculated positions of one or more LAA occlusion device electrodes 80-88 can be used to determine the position and orientation of at least a portion of the LAA occlusion device 30. In some examples, the navigation computer system 20 generates images of the LAA occlusion device 30 and / or delivery device 70 superimposed on images of the anatomical structures of the patient 11. The generated images can be displayed in real time on a display 23 communicatively coupled to the navigation computer system 20. In some examples, the navigation computer system 20 is provided with a 3D geometry of the anatomical structures of the patient 11, such as a depiction of a portion of the patient's heart 100, and the generated images include the LAA occlusion device 30 and / or delivery device 70 superimposed on the 3D geometry diagram.

[0050] Alternatively or additionally, the medical navigation system 5 may use navigation nodes based on magnetic sensors. Alternatively or additionally, one or more electrodes on the LAA occlusion device 30 may be replaced with multiple magnetic sensors, such as coils configured to be electrically coupled to the medical navigation system 5. A magnetic field is generated around the patient 11, for example, by using coils housed beneath the patient 11. When a magnetic sensor is moved within the magnetic field, an electric current is generated and detected by the medical navigation system 5.

[0051] Exemplary LAA treatment The medical navigation system 5 provides guidance for the navigation, positioning, and / or deployment of intravascular delivery devices during endovascular procedures, such as LAA occlusion, but is not limited to these. Figures 6A–6F show the stages of placement of an exemplary LAA occlusion device 30 after the catheter tip 76 of the delivery device 70 has been positioned within the LAA 160. The delivery device 70 is navigated through the patient's vascular structure using the medical navigation system 5. Navigation can be performed based on electrode data corresponding to electrodes 80–88 of the delivery device 70. For example, the catheter tip 76 can be positioned within the LAA, adjacent to the LAA, preferably coaxially within the LAA, based on electrode data displayed by the medical navigation system 5, thus minimizing and / or eliminating the need for fluoroscopy.

[0052] In Figure 6A, the LAA occlusion device 30 is partially translated from the catheter tip 76, so that the lobe 32 of the LAA occlusion device 30 is partially expanded into a ball shape. The ball shape creates a non-injury distal tip. The delivery device 70 can then be further advanced within the LAA 160 to a desired deployment position relative to the landing section 92. For example, the landing section 92 can be the optimal position for deploying the lobe 32 of the LAA occlusion device 30 within the LAA 160. Electrodes 48 positioned at the distal tip and electrode 50 positioned adjacent to the distal screw or clamp 40 generate a local dipole signal at the distal end of the LAA occlusion device 30. The navigation computer system 20 processes electrode data from electrodes 48-50 to determine the position of the distal screw 40 or clamp within the LAA 160, reducing and / or eliminating reliance on fluoroscopy or ultrasound imaging. The medical navigation system 5 can display navigation guidance information generated based on electrode data on the display 23 of the navigation computer system 20, and / or one or more other displays.

[0053] When advancing the LAA occlusion device 30 in a ball configuration, it is desirable to minimize inadvertent contact with the LAA wall 161. For example, such inadvertent contact may indicate that the LAA occlusion device 30 is too deep within the LAA 160, or that the LAA occlusion device 30 is applying undesirable pressure to the distal LAA wall 161. In some embodiments, by using electrode 48 as a reference electrode and electrode 50 as an indicator electrode, the navigation computer system 20 can detect inadvertent contact between the distal screw or clamp 40 and the LAA wall 161. Figures 6E–6F show impedance fields 90 detectable by the navigation computer system 20 when the navigation computer system 20 controls the driving of the corresponding electrodes 48–50. The navigation computer system 20 can detect inadvertent contact shown in Figure 6F by analyzing electrode data describing the impedance field 90. In some examples, the navigation computer system 20 detects cardiac signals with localized sharp potential diagrams and corrections to the dipole impedance associated with the corresponding electrodes 48–50.

[0054] When such contact is detected at this stage, the navigation computer system 20 can notify the physician operating the delivery device 70 of the contact. For example, electrode data collected by the navigation computer system 20 may include intracardiac electrograms recorded by the indicator electrode 48 and the reference electrode 50. The navigation computer system 20 can generate navigation guidance information regarding inadvertent contact between the distal tip of the LAA occlusion device 30 and the LAA wall 161 at the indicator electrode 48 positioned on the distal screw or clamp 40. For example, the navigation computer system 20 can provide real-time feedback regarding the inadvertent contact on a display 23 communicably coupled to the navigation computer system 20.

[0055] After the LAA occlusion device 30 reaches the desired deployment position relative to the landing section 92 in the ball configuration shown in Figure 6A, the physician may further deploy the LAA occlusion device 30 so that the lobe 32 first expands into the triangular configuration shown in Figure 6B, and then fully expands into the cylindrical configuration shown in Figure 6C. After the deployment of the lobe 32 is complete, electrodes 58-62 positioned on the sides of the lobe 32 are expected to make contact with the LAA wall 161. In some embodiments, by using electrodes 58-62 positioned on the sides of the lobe 32 as indicator electrodes, the navigation computer system 20 can evaluate the contact between the lobe 32 and the LAA wall 161. In some embodiments, electrode 50 is used as a reference electrode for electrodes 58-62. Electrode data collected by the navigation computer system 20 may include intracardiac electrograms recorded by the indicator electrodes 58-62 and the reference electrode 50. The navigation computer system 20 can generate navigation guidance information regarding the contact quality between the lobe 32 and the LAA wall 161 at indicator electrodes 58-62 located on the sides of the lobe 32. For example, the navigation computer system 20 can provide real-time feedback regarding the contact quality on a display 23 that is communicatively coupled to the navigation computer system 20.

[0056] In Figure 6D, the physician unfolds the disc 34 of the LAA occlusion device 30. Upon completion of the unfolding of the disc 34, electrodes 52-56 positioned on the surface of the disc 34 are exposed. Specifically, one or more electrodes 52-54 positioned on the edge surfaces of the disc 34 are expected to contact the LAA wall 161. In some embodiments, by using electrode 56 positioned as a reference electrode near the center of the proximal surface of the disc 34 and one or more electrodes 52-54 positioned on the edge surfaces of the disc 34 as indicator electrodes, the navigation computer system 20 can evaluate contact between the disc 34 and the LAA wall 161 at the mouth of the LAA wall 161. When contact is detected at this stage, the navigation computer system 20 can notify the physician operating the delivery device 70 of the contact. Electrode data collected by the medical navigation system 5 may include intracardiac electrograms recorded by the indicator electrodes 52-54 and the reference electrode 50. The navigation computer system 20 can generate navigation guidance information regarding the contact quality between the disk 34 and the LAA wall 161 at the indicator electrodes 52-54 located on the edge surface of the disk 34. For example, the navigation computer system 20 can provide real-time feedback regarding contact quality on a display 23 that is communicatively coupled to the navigation computer system 20.

[0057] A more detailed explanation regarding the evaluation of contact quality is provided with reference to Figures 7A–7D. Figure 7A shows an exemplary pair of electrodes 201–206 positioned on the surface of an exemplary LAA occlusion device 30. Electrode 201 is a reference electrode positioned adjacent to the base of the distal screw or clamp of the LAA occlusion device 30. Electrodes 202–203 are positioned on the sides of the lobes 32 of the LAA occlusion device 30. Electrodes 204–205 are positioned on the edge surfaces of the disc 34 of the LAA occlusion device 30. Electrode 206 is a reference electrode positioned near the center of the proximal surface of the disc 34 of the LAA occlusion device 30.

[0058] Figure 7B shows exemplary electrocardiogram data corresponding to electrodes 201-206. Electrode data collected by the navigation computer system 20 may include intracardiac electrograms recorded by indicator electrodes 202-205 and reference electrodes 201, 206. Figure 7C shows a graph illustrating poor contact quality between the lobe 32 of the LAA occlusion device 30 and the LAA wall 161 at electrode 202. The graph is generated by subtracting the electrical signal to electrode 201 from the electrical signal to electrode 202 when electrode 201 functions as the reference electrode and electrode 202 functions as the indicator electrode. Figure 7D shows a graph illustrating good contact quality between the disc 34 of the LAA occlusion device 30 and the LAA wall 161 at electrode 205. The amplitude of the periodic spikes indicates the degree of contact. For example, when the LAA occlusion device 30 applies greater pressure to a particular electrode, the corresponding amplitude will be higher. The graph is generated by subtracting the electrical signal to electrode 206 from the electrical signal to electrode 205, where electrode 206 functions as a reference electrode and electrode 205 functions as an indicator electrode. The magnitude of the subtracted electrical signals in Figures 7C–7D provides a quantified reference that describes the degree of contact between the corresponding electrodes 202, 205 and the LAA wall 161. In some embodiments, the navigation computer system 20 generates and displays navigation guidance information regarding real-time electrode data and / or contact quality on a display 23 communicatively coupled to the navigation computer system 20. Hereinafter, the term electrode data may include raw electrode data and / or processed electrode data collected from any one or any combination of electrodes 48–62 of the LAA occlusion device 30, electrodes 80–88 of the delivery device 70, and / or electrodes 18, 19, 12, 14, 16, 22, 21 of the medical navigation system 5.

[0059] In some embodiments, the medical navigation system 5 is used, but is not limited to, to standardize device placement verification techniques, such as tensile testing. Tensile testing is a procedure performed by a physician after the disc 34 has been fully deployed and before releasing the LAA occlusion device 30 from the push rod in the delivery device 70 (e.g., by unscrewing it). The physician applies a clinically relevant force, such as by pulling or tugging the push rod (and optionally the delivery device 70), and subjectively assesses whether the resistance perceived by the physician is sufficient to indicate secure fixation of the LAA occlusion device 30 within the LAA.

[0060] The techniques described herein enable the quantification of contact with and / or pressure applied to the LAA wall 161 by the corresponding electrodes of the LAA occlusion device 30. For example, the device placement confirmation technique can be performed while observing output data presented on the display 23 of the medical navigation system 5. In some examples, one or more standardized values, such as one or more amplitudes of subtracted electrical signals, can be set as sufficiency thresholds. The sufficiency threshold is a value for a parameter indicating secure fixation of the LAA occlusion device 30. The sufficiency threshold can correspond to changes in electrical signals observed when no pressure is applied to the push rod and / or delivery device 70 and the LAA occlusion device 30 is implantable in an unfolded state. Alternatively or additionally, the sufficiency threshold can correspond to electrical signals observed when a physician performs a tensile test. Alternatively or additionally, the sufficiency threshold can correspond to electrical signals observed when a standardized magnitude pressure is applied proximal to the delivery device 70. In some embodiments, one of the indicator electrodes is configured to be bipolar with the reference electrode. A three-dimensional shading of the bipolar configuration in a non-stretched control state is provided by the navigation computer system 20 before the start of the tensile test. By combining the correction of the impedance signal with a comparison of the new position of the electrodes to the initial position still indicated by the electrode shading, an indication of the tensile force to be generated during the tensile test is provided.

[0061] Implementation mechanism - Hardware overview The techniques described herein can be implemented by one or more special-purpose computing devices. A special-purpose computing device may be hardwired to implement one or more of the techniques described herein, including combinations thereof. Alternatively and / or additionally, one or more special-purpose computing devices may include one or more digital electronic devices, such as application-specific integrated circuits (ASICs) or field-programmable gate arrays (FPGAs), that are continuously programmed to implement these techniques. Alternatively and / or additionally, one or more special-purpose computing devices may include one or more general-purpose hardware processors programmed to implement the techniques described herein according to firmware, memory, other storage devices, or program instructions in a combination thereof. Such special-purpose computing devices may also combine custom hardwired logic, ASICs, or FPGAs with custom programming to implement these techniques. A special-purpose computing device may be a desktop computer system, a portable computer system, a handheld device, a networking device, and / or any other device that incorporates hardwired or programmed logic to implement these techniques.

[0062] Figure 8 is a block diagram showing a computer system that can implement one or more examples. The computer system 400 includes a bus 402 or other communication mechanism for communicating information and one or more hardware processors 404 coupled to the bus 402 to process information such as computer instructions and data. The processors 404 may include one or more general-purpose microprocessors, graphics processing units (GPUs), coprocessors, central processing units (CPUs), and / or other hardware processing units.

[0063] The computer system 400 also includes one or more units of main memory 406 coupled to bus 402, such as random access memory (RAM) or other dynamic storage device, for storing information and instructions executed by the processor 404. The main memory 406 can also be used to store temporary variables or other intermediate information during the execution of instructions executed by the processor 404. When such instructions are stored in a non-temporary storage medium accessible by the processor 404, the computer system 400 becomes a special-purpose machine customized to perform the operations specified in the instructions. In some embodiments, the main memory 406 may include dynamic random access memory (DRAM) (including, but not limited to, double data-rate synchronous dynamic random access memory (DDR SDRAM), thyristor random access memory (T-RAM), zero-capacitor (Z-RAM®)), and / or non-volatile random access memory (NVRAM).

[0064] The computer system 400 may further include one or more units of read-only memory (ROM) 408 or other static storage devices coupled to the bus 402 for storing information and instructions for the processor 404, which are always static or static in normal operation but reprogrammable. For example, ROM 408 may store firmware for the computer system 400. ROM 408 may include a mask ROM (MROM) or other hardwired ROM for storing purely static information, a programmable read-only memory (PROM), an erasable programmable read-only memory (EPROM), an electrically erasable programmable read-only memory (EEPROM), another hardware memory chip or cartridge, or any other read-only memory unit.

[0065] One or more storage devices 410, such as magnetic disks or optical disks, are provided to and coupled to the bus 402 for storing information and / or instructions. The storage devices 410 may include, for example, read-only memory, optical disks (but not limited to, compact discs (CDs), digital video discs (DVDs), Blu-ray® discs (BDs)), magnetic disks, other magnetic media such as floppy disks and magnetic tapes, solid-state drives, flash memory, optical disks, one or more forms of non-volatile random-access memory (NVRAM), and / or other non-volatile storage media.

[0066] The computer system 400 can be coupled to one or more input / output (I / O) devices 412 via a bus 402. For example, the I / O devices 412 may include one or more displays for displaying information to the computer user, such as cathode ray tube (CRT) displays, liquid crystal display (LCD) displays, light-emitting diode (LED) displays, projectors, and / or any other type of display.

[0067] I / O device 412 may also include one or more input devices, such as an alphanumeric keyboard and / or any other keypad device. One or more input devices may also include one or more cursor control devices, such as a mouse, trackball, touch input device, or cursor directional keys, for communicating directional information and command selection to processor 404 and controlling the movement of a cursor on another I / O device (e.g., a display). A cursor control device typically has two or more degrees of freedom (e.g., a first axis x, a second axis y, and optionally one or more additional axes z) that allow the device to specify a position in a plane. In some embodiments, one or more I / O devices 412 may include a device that combines I / O functions, such as a touch-operable display.

[0068] Other I / O devices 412 may include imaging devices such as fingerprint readers, scanners, infrared (IR) devices, cameras or video recording devices, microphones, speakers, ambient light sensors, pressure sensors, accelerometers, gyroscopes, magnetometers, other motion sensors, or any other devices that can communicate signals, commands, and / or other information with processor 404 via bus 402.

[0069] The computer system 400 may implement the techniques described herein using customized hardwired logic, one or more ASICs or FPGAs, firmware, and / or program logic to make the computer system 400 a special-purpose machine. In some examples, the techniques described herein are performed by the computer system 400 in response to the processor 404 executing one or more sequences of one or more instructions contained in main memory 406. Such instructions can be read into main memory 406 from another storage medium, such as one or more storage devices 410. By executing the sequence of instructions contained in main memory 406, the processor 404 performs the process steps described herein. In alternative embodiments, hardwired circuits may also be used instead of, or in combination with, software instructions.

[0070] The computer system 400 also includes one or more communication interfaces 418 coupled to bus 402. The communication interfaces 418 provide bidirectional data communication over one or more physical or wireless network links 420 connected to a local network 422 and / or a wide area network (WAN), such as the Internet. For example, the communication interface 418 may include an Integrated Services Digital Network (ISDN) card, a cable modem, a satellite modem, or a modem for providing data communication connectivity to a corresponding type of telephone line. Alternatively and / or additionally, the communication interface 418 may include one or more of the following: a local area network (LAN) device that provides data communication connectivity to a compatible local network 422; a wireless local area network (WLAN) device that transmits and receives wireless signals (such as electrical signals, electromagnetic signals, optical signals, or other wireless signals representing various types of information) to and from a compatible LAN; a wireless wide area network (WWAN) device that transmits and receives such signals over a cellular network; and other networking devices that establish a communication channel between the computer system 400 and one or more LANs 422 and / or WANs.

[0071] A network link 420 typically provides data communication to other data devices over one or more networks. For example, a network link 420 may provide connectivity to one or more host computers 424 or to data devices operated by an Internet Service Provider (ISP) 426 over one or more local area networks 422 (LANs). The ISP 426 provides connectivity to one or more wide area networks 428, such as the Internet. LANs 422 and WANs 428 use electrical, electromagnetic, or optical signals to carry digital data streams. Signals traversing various networks and signals traversing the communication interface 418 on the network link 420 are exemplary forms of transmission or temporary media.

[0072] In this specification, the term “storage medium” refers to any non-transient medium that stores data and / or instructions that cause a machine to operate in a particular manner. Such storage mediums may include volatile and / or non-volatile media. A storage medium is separate from a transmission medium but can be used together with a transmission medium. A transmission medium is involved in the transfer of information between storage mediums. For example, a transmission medium may include coaxial cables, copper wires, and optical fibers, which include traces and / or other physical conductive components, including bus 402. A transmission medium may also take the form of sound waves or light waves, such as those generated during radio and infrared data communications.

[0073] When transporting one or more instructions, one or more sequences, to the processor 404 for execution, various forms of media can be used. For example, the instructions may initially be held on a magnetic disk or solid-state drive of a remote computer. The remote computer may load the instructions into its main memory 406 and transmit the instructions via a telecommunications line using a modem. A local modem of the computer system 400 may receive the data over a telephone line and convert the data into an infrared signal using an infrared transmitter. An infrared detector may receive the data transported as an infrared signal, and a suitable circuit may place the data on the bus 402. The bus 402 transports the data to the main memory 406, and the processor 404 retrieves the instructions from the main memory 406 and executes them. The instructions received by the main memory 406 may optionally be stored in a storage device 410 before or after execution by the processor 404.

[0074] The computer system 400 can send messages and receive data, including program code, via the network, network link 420, and communication interface 418. In the case of the internet, one or more servers 430 can transmit signals corresponding to data or instructions requested for application programs executed by the computer system 400 via the internet 428, ISP 426, local network 422, and communication interface 418. The received signals may include instructions and / or information for execution and / or processing by the processor 404. The processor 404 can execute and / or process the instructions and / or information later, either by accessing the main memory 406 when it receives the signal, or by storing the signal and then accessing the signal from the storage device 410.

[0075] Other forms of disclosure While the concepts described herein have been explained with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and the field of application of this disclosure. Therefore, it should be understood that numerous modifications can be made to the exemplary embodiments and other arrangements can be devised without departing from the spirit and scope of this disclosure as defined by the appended claims.

Claims

1. A medical navigation system for intravascular procedures, A delivery device equipped with a catheter, An intravascular delivery device configured to be releasably positioned within the catheter for deployment at a target site in the patient, comprising a plurality of electrodes, the plurality of electrodes including at least one indicator electrode and at least one reference electrode configured so as not to come into contact with tissue when the intravascular delivery device is deployed at the target site, A navigation computer system configured to be electrically coupled to the plurality of electrodes, comprising one or more processors and at least one memory for storing instructions, wherein when an instruction is executed by the one or more processors, the one or more processors The drive source is controlled to transmit current to the aforementioned multiple electrodes. Collect electrode data corresponding to the aforementioned multiple electrodes, Based on the electrode data, the impedance corresponding to the at least one indicator electrode is monitored. A navigation computer system that determines, based on the electrode data, that at least one indicator electrode has come into contact with the tissue. A medical navigation system equipped with [features / equipment].

2. The medical navigation system according to claim 1, wherein the intravascular delivery device is an LAA occlusion device, the target site is the patient's LAA, and the tissue is the LAA wall.

3. The LAA occlusion device includes a disc at the proximal end of the LAA occlusion device, The at least one indicator electrode is located on the edge surface of the disc. The medical navigation system according to claim 2.

4. The medical navigation system according to claim 3, wherein the plurality of electrodes include at least two indicator electrodes arranged on the edge surface of the disc and spaced substantially uniformly apart around the edge surface.

5. The LAA occlusion device includes a lobe at the distal end of the LAA occlusion device. The at least one indicator electrode is located on the side of the lobe. The medical navigation system according to claim 2.

6. The medical navigation system according to claim 5, wherein the at least one electrode is located on the distal edge of the side surface of the lobe.

7. The medical navigation system according to claim 5, wherein the at least one electrode is located on the proximal edge of the side surface of the lobe.

8. The medical navigation system according to claim 5, wherein the at least one electrode is positioned between the distal and proximal edges of the side surface of the lobe.

9. The medical navigation system according to claim 1, wherein the at least one indicator electrode includes a first indicator electrode that is expected to come into contact with the tissue when the intravascular delivery device is deployed at the target site.

10. The medical navigation system according to claim 1, wherein when the instruction is executed by the one or more processors, the one or more processors are instructed to evaluate the degree of contact between the at least one indicator electrode and the tissue based on electrode data corresponding to the at least one reference electrode and the at least one indicator electrode.

11. The medical navigation system according to claim 1, wherein evaluating the degree of contact between the at least one indicator electrode and the tissue includes subtracting an electrode signal corresponding to the at least one reference electrode from an electrode signal corresponding to the at least one indicator electrode and analyzing the amplitude of the resulting signal.

12. The medical navigation system according to claim 1, wherein the at least one indicator electrode includes a second indicator electrode which is expected not to come into contact with the tissue when the intravascular delivery device is deployed at the target site.

13. The medical navigation system according to claim 12, wherein when the instruction is executed by the one or more processors, the one or more processors cause a warning notification to be generated when the second indicator electrode comes into contact with the tissue.

14. The at least one indicator electrode includes a third indicator electrode which is expected not to come into contact with the tissue when the intravascular delivery device is deployed at the target site, The third indicator electrode is positioned at the distal tip of the LAA occlusion device. The medical navigation system according to claim 2.

15. The medical navigation system according to claim 1, wherein the navigation computer system monitors the impedance corresponding to the at least one indicator electrode based on electrode data generated based on three pairs of electrodes placed on the patient's surface during the intravascular procedure.

16. When the instruction is executed by one or more processors, the one or more processors: Based on the electrode data corresponding to the plurality of electrodes, the position and orientation of the intravascular delivery device are determined. The medical navigation system according to claim 1, wherein a display communicatively coupled to the navigation computer system displays a depiction of the intravascular delivery device in relation to a depiction of the patient's anatomical structure.

17. The medical navigation system according to claim 16, wherein the depiction of the patient's anatomical structure is based on a 3D model of the patient's anatomical structure generated before the intravascular procedure.

18. The catheter is a controllable catheter and comprises a plurality of second electrodes positioned at the distal end of the controllable catheter. When the instruction is executed by one or more processors, the one or more processors: The location of each of the aforementioned multiple electrodes is determined. Determine the configuration and location of the distal end of the controllable catheter. A medical navigation system according to claim 2, wherein a display communicatively coupled to the navigation computer system displays a depiction of the distal end of the maneuverable catheter device relative to the anatomical structure of the patient.

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