WO2025158231A1 - Anatomical model for use in developing and testing intravascular tools and procedures - Google Patents

Abstract

Anatomical models and methods are disclosed for use in simulating vascular procedures using elongate vascular tools. Intravascular path models include simulated vasculature leading to a target location, the simulated vasculature navigable by an elongate vascular tool. Target tissue is positioned at the target location and configured to provide electrical and tactile feedback during a vascular procedure using the elongate vascular tool, such procedures including pacing lead implantation, tunneling, ablation, and the like. A fluid is provided that sufficiently approximates the conductivity of a blood environment so that electrical signals can be monitored indicative of a positioning of the elongate vascular tool within the simulated vasculature. One or more electrodes may be used to generate electrophysiological signals in the model such as would be present during a live procedure.

Description

ANATOMICAL MODEL FOR USE IN DEVELOPING AND TESTING INTRAVASCULAR TOOLS AND PROCEDURES

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63/623,550, filed January 22, 2024, the entire content of which is incorporated herein by reference.

[0002] The present disclosure generally relates to the use of anatomical models to demonstrate, develop and test intravascular tools and devices and to practice vascular procedures such as pacing lead implantation and other procedures.

SUMMARY

[0003] Techniques and systems of the present disclosure generally relate to intravascular path models for simulating cardiac and vascular procedures using elongate vascular tools that may be catheter-enabled or delivered without a catheter. In certain aspects, intravascular path models of the present disclosure include simulated vasculature leading to a target location, the simulated vasculature navigable by an elongate vascular tool. Target tissue is positioned at the target location and configured to provide realistic tactile feedback during a vascular procedure (such as implantation, tunneling, ablation, or the like) using the elongate vascular tool. A fluid is provided that sufficiently approximates the conductivity of a blood environment such that when the simulated vasculature and target tissue are submerged in the fluid, electrical signals can be monitored indicative of a positioning of the elongate vascular tool within the simulated vasculature. One or more electrodes positioned in, on, or around the target tissue and/or the simulated vasculature may be used to generate electrophysiological signals such as would be present during a live procedure.

[0004] In certain aspects, the simulated vasculature may be formed using additive manufacturing or by a molding process. In certain aspects the simulated vasculature may be formed from animal tissue. The simulated vasculature may also be provided in a modular form so that different environments may be simulated by differently arranging the modules. The target tissue may be synthetic tissue or animal tissue, and may be attached to the simulated vasculature by any suitable means, including using a removable and attachable frame or bracket so that the target tissue can be replaced and/or repositioned.

[0005] In certain aspects, the simulated vasculature replicates at least a portion of anatomy traversed to reach a ventricular septal wall or an atrial septal wall in the heart, and the target tissue is synthetic or animal septal tissue.

[0006] In certain aspects, the one or more electrodes are configured to simulate a portion of a conductive pathway in the heart.

[0007] In certain aspects, the one or more electrodes include one or more sensors configured to provide feedback during a simulated ablation procedure. For example, the sensors may be temperature sensors. In addition, one or more wires may be arranged in the target tissue to provide a conductive path that is detectably altered when subjected to a successful ablation procedure.

[0008] In certain aspects, the target tissue and electrodes positioned near the target area are arranged such that they can be provided with electrophysiological signals that simulate a specific location such as the left bundle branch (LBB) or the His bundle.

[0009] In certain aspects, the target location simulates an area of a ventricle wall or an atrial wall.

[0010] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] FIG. 1 is a schematic representation of an apparatus that includes an anatomical path model in accordance with the present disclosure.

[0012] FIG. 2A is a schematic representation of a heart environment during an implant procedure that may be simulated using devices and methods in accordance with the present disclosure. [0013] FIG. 2B is a schematic representation of target tissue attached to simulated vasculature in accordance with aspects of the present disclosure.

[0014] FIG. 3 is block diagram of an anatomical model system in accordance with aspects of the present disclosure.

[0015] FIG. 4 is a flow chart depicting steps useful in methods in accordance with the present disclosure.

DETAILED DESCRIPTION

[0016] All scientific and technical terms used herein have meanings commonly used in the art unless otherwise specified. The definitions provided herein are to facilitate understanding of certain terms used frequently herein and are not meant to limit the scope of the present disclosure. As used herein, “vascular procedure” encompasses procedures in or around the heart or other vasculature including implantation (such as implantation of pacing leads and leadless pacemakers), ablation, tunneling, and other similar procedures and steps involved therein.

[0017] The present disclosure relates to anatomical path models that provide physical and electrical feedback. Such anatomical models may be useful in developing, testing, and practicing various vascular procedures, as well as in developing and testing tools employed in such procedures.

[0018] Acute animal studies are an expensive and time-consuming aspect of the product development process, and as such the present disclosure sets forth anatomical path models that simulate or replicate certain conditions experienced in animal studies in a manner that can be executed in a benchtop apparatus. Such a benchtop apparatus may be 3D printed or molded, and may be constructed in modular form. Certain modules may include animal or synthetic tissue, for example positioned at a target location for simulation of implant, tunneling, ablation, or other such procedures.

[0019] Anatomical path models in accordance with the present disclosure may be submerged in a solution that sufficiently replicates blood in a body environment. For example, the solution can be formulated to have the viscosity, lubricity, and conductivity of a blood environment at body temperatures. The conductivity allows the use of electrical monitoring in a manner that is similar to the electrical monitoring that would be conducted during live procedures.

[0020] One application for anatomic path models in accordance with the present disclosure is LBB pacing. A path model may be designed that replicates at least a portion of the anatomy traversed to reach the ventricular septal wall. At the target location, explanted septal tissue or synthetic septal tissue is provided to simulate the tactile environment and other physical characteristics of performing an implant-type or other vascular procedure at a septal wall. An operator can guide a catheter through the path model and perform a procedure such as implanting a lead in the target tissue that simulates a septal wall. The target location can be found by monitoring impedance between a tip of the implant tool (which may be, for example, the tip of a lead being implanted) and a separate return electrode also on the implant tool (for example, also near the tip of the lead). The impedance will vary with proximity to the one or more electrodes disposed in or on the simulated vasculature of the path model and/or the simulated septal target tissue. The one or more electrodes can be arranged and activated so that they simulate the signals expected in a live procedure.

[0021] In certain aspects, anatomic path models of the present disclosure may be used to test and develop implant tools and procedures, to demonstrate devices and procedures to customers for information or feedback, for learning and practice, and for marketing. Anatomic path models in accordance with the present disclosure can be designed to be easily transportable, and thus suitable for demonstration at physician conferences.

[0022] For LBB pacing, apparatuses of the present disclosure can be used to practice LBB implant procedures with new catheter and/or lead designs. It can also be used to market developed products to customers. For example, physicians can implant an LBB pacing lead such as ones commercially available under the trade name Select Secure™ Model 3830 MRI lead, and using a suitable delivery catheter (such as those commercially available under the trade name LANTERN™). The anatomical path model including simulated septal tissue and simulated blood environment solution allow the physician or other operator to experience realistic physical feedback and to use standard electrical monitoring tools. [0023] Other example procedures that can be suitably used with anatomic path models of the present disclosure include simulating or practicing implanting leadless pacing devices (such as those available under the trade name Micra™), implanting defibrillation leads, and performing catheter-enabled ablation. Apparatuses of the present disclosure can be used with these or any procedure that utilizes catheter-enabled vascular tools as well as elongate vascular tools delivered without a catheter, and in which using electrical signals can help locate a target location at which the vascular tool is used to manipulate tissue, whether that manipulation is by implanting, fixating, tunneling, cutting, ablating, or the like.

[0024] Anatomical models of the present disclosure incorporate real or synthetic tissue to mimic the physical and electrical feedback encountered in live procedures. The real or synthetic tissue may be infused or saturated with a conductive media to simulate a conduction pathway. In addition, one or more electrodes or electrode arrays may be used to simulate the presence of electrophysiological signals. For lead implant procedures, the electrodes can be arranged and activated to simulate different locations or environments that would be expected at or around the target location, including the LBB or His-bundle. The electrodes can also be arranged and activated to simulate unique or abnormal environments, such as LBB blocks. For ablation procedures, sensors may be used to measure the temperature increase from a simulated ablation, or electrodes or wires can be configured such that an ablation procedure either breaks or fuses electrical components, thereby altering the conductive pathway and providing confirmation of successful ablation, as well as to confirm the location of ablation.

[0025] Reference will now be made to the drawings, which depict one or more aspects described in this disclosure. However, it will be understood that other aspects not depicted in the drawings fall within the scope of this disclosure. Like numbers used in the figures refer to like components, steps, and the like. However, it will be understood that the use of a reference character to refer to an element in a given figure is not intended to limit the element in another figure labeled with the same reference character. In addition, the use of different reference characters to refer to elements in different figures is not intended to indicate that the differently referenced elements cannot be the same or similar. [0026] FIG. 1 schematically depicts an example arrangement for utilizing an anatomic path model. Apparatus 100 includes simulated vasculature 110 having at least one pathway 112 navigable by an elongate vascular tool 140 to a target location where target tissue 120 is attached to the simulated vasculature 110. As shown, the simulated vasculature 110 is submerged in a solution 130 that is held in a tank 132 and kept at a desired temperature, for example at body temperature, using a heating element 134. Heating element 134 may also recirculate the solution to maintain a consistent temperature throughout the solution bath. Elongate vascular tool 140 is navigated, either with or without the aid of catheter 142, to a location where a tip 144 of the tool 140 is near the target tissue 120. Monitoring electronics 150 are coupled to the tool 140 for monitoring impedance or other signals indicative of the positioning of the tool relative to the target location as well as success metrics related to the procedure being demonstrated, developed, or tested. Signal generator electronics 160 are coupled to the electrode(s) in the simulated vasculature 110 and/or target tissue 120, for example to provide a waveform that simulates electrophysiological signals in the body.

[0027] Target tissue 120 and/or simulated vasculature 110 includes one or more electrodes, an electrode array, wires, or other electrical components suitable for providing the simulation of electrical pathways in tissue, for producing simulated electrophysiological signals, or for otherwise interacting with or reacting to stimulation from the elongate vascular tool. For example, an impedance between electrodes on the vascular tool can be detected to determine the position of the tip relative to one or more electrodes positioned at or near a target location. When the tool is used to implant or fixate leads in the target tissue, the impedance signal can be used to determine the initiation of fixation in the target tissue, as well as the extent of fixation, over-fixation, or perforation of the target tissue. This can be done while simulated electrophysiological signals are produced through the electrodes. In other examples, sensors can be embedded in or disposed on the simulated vasculature or the target tissue to sense temperature changes due to ablation or other procedures. In yet other examples, wires or wire mesh can be embedded in or disposed on the simulated vasculature or the target tissue to detect breaking or fusing of the wires under ablation, tissue cutting or tunneling, or lead implantation and fixation. [0028] The simulated vasculature can be formed from any suitable materials, and may be made by additive manufacturing (e.g., 3D printing), by molding, or by other suitable methods. Anatomical path models have been manufactured using clear silicone molds, stereolithography (SLA) 3D printers, and material jetting 3D printers. A clear 50 A shore durometer SLA material has been used in prototyping. The durometer of the material can be selected to desirably mimic the stiffness of tissue. The transparency of the simulated vasculature can be clear or opaque depending on the whether visually seeing the implant is important for the specific project.

[0029] The target tissue can be animal or synthetic tissue, and preferably mimics the physical characteristics that would be encountered at the target area when performing a live vascular procedure. For example, explanted ventricular septum tissue from pig or sheep hearts can be readily used. Synthetic tissue made using silicone molding or additive manufacturing that mimics the stiffness of the target tissue can also be used. When using synthetic tissue, it can be manufactured using additives to yield a conductivity that mimics the tissue being simulated.

[0030] The solution in which the path model is submerged can be any suitable solution that mimics the electrical conductivity of a blood environment. In certain embodiments, the solution preferably also mimics the lubricity and viscosity of a blood environment at body temperatures. An NaCl aqueous solution having a density of 3.5 g/L can be suitably used because it provides a good match for the electrical conductivity of blood. In another example, a solution can be made that includes liquid in an amount of 70% by volume of water, 28% by volume of glycerine, and 2% by volume of polyvinylpyrrolidone (PVP), and with NaCl dissolved into the liquid at a density of 3.5 g/L. Adding glycerine and PVP helps form a solution that mimics the viscosity and lubricity of blood.

[0031] The elongate vascular tool can be any tool for use in vascular procedures such as implanting and/or fixating pacing leads or leadless pacing devices, for tunneling through tissue, for ablating tissue, for cutting tissue, and the like, and can be delivered using a catheter or without. Examples include the 3830 lead, Micra™ devices, LANTERN™ catheter devices, and Micra™ catheter devices, all available from Medtronic. Example ablation devices include the PulseSelect and CryoCath ablation systems available from Medtronic.

[0032] In one example, in an apparatus such as schematically shown in FIG. 1, a 1.5 inch by 1.5 inch size piece of septal tissue from the heart of a pig was affixed to a 3D printed path model representing the path from a subclavian venous access point to the ventricular septum of a human. The septal tissue was affixed at a location representative of the ventricular septum. An electrode was affixed to the back of the septal tissue. The path model with the affixed septal tissue and electrode was submerged in bath of a 3.5 g/L NaCl aqueous solution that was maintained at a temperature of 37 degrees Celsius. A QRS wave was transmitted to the electrode and thus into the tissue using a function generator, with the waveform simulating electrical activity coming from the LBB. A catheter-enabled guide wire and lead were already installed, with the lead having a bipolar electrode allowing it to sense location in the anatomy.

[0033] Impedance between the lead tip and the return electrode was measured and monitored during a simulated implant procedure. The impedance changes based on how deeply implanted the lead is in tissue. The impedance signal was observed as the lead approached the target tissue, during initial contact with the target tissue, during fixation of the lead in the target tissue, during over-fixation of the lead in the target tissue, and after perforation of the target tissue by the lead. The behavior of the impedance signal followed the same trend as would be expected in a live procedure. Using the same setup, different waveforms can be produced to mimic electrical activity coming from different areas of the heart anatomy as well as mimicking electrical activity from abnormal anatomies or injured tissue.

[0034] Anatomic path models in accordance with the present disclosure may also be used to simulate procedures that employ the use of return electrodes that are located away from the target tissue. For example, remote electrodes can be used to simulate the grounding pads typically attached to the patient’s skin in unipolar pacing applications. With unipolar tools, a return electrode is typically attached to the patient’s skin to complete the electrical circuit. To simulate this using anatomical path models in accordance with the present disclosure, a return electrode that is external to the model can be added in the tank for signal measuring and monitoring. In such embodiments, it may be preferable to use a porous path model so that there is a conductive pathway through the immersion fluid from the unipolar tool to the return electrode. The use of a non-porous, or solid, path model in such applications may present a situation where the electrical resistance through the path model from the unipolar tool to the return electrode would greatly exceed the electrical resistance of living tissue. Remotely located return electrodes and porous path models may be particularly useful in simulating unipolar pacing procedures as well as unipolar RF ablation and electrocauterization procedures.

[0035] FIG. 2A schematically depicts a portion of a heart vasculature during a lead implant procedure that may be simulated using anatomic path models and methods in accordance with the present disclosure. For illustration, a right ventricle 212A and a portion of a left ventricle 214A are shown along with ventricular septum 220A. Also indicated is a portion of a conductive pathway including AV node 226A, His-bundle 224A, and LBB 222A. Catheter-enabled implant tool 240A is shown entering the right ventricle 212A and implanting a lead 244A in the septal wall 220A near the LBB 222A. For ease of illustration, lead 244A is shown to have a spiral configuration (such as the helix electrode on the Medtronic 3830 lead), but it will be appreciated that a variety of leads can be used based on what is suitable for the procedure.

[0036] FIG. 2B schematically depicts a portion of an anatomical path model, for example to simulate the procedure illustrated in FIG. 2A of implanting a lead in septal tissue near the LBB. In FIG. 2B, target tissue 220B that mimics ventricular septum tissue (whether animal tissue or synthetic) is attached to an inside surface of simulated vasculature 210B. Electrodes 222B, 224B, and 226 B are shown disposed between the target tissue 220B and simulated vasculature 210B, although the electrodes can be positioned wherever desired on or in the implant tissue or simulated vasculature, including embedded within the tissue(s). Target tissue 220B can be directly attached to the simulated vasculature 210B by sutures or another attachment means, or target tissue 220B can be attached to a bracket or frame that is then removably attached to simulated vasculature 210B so that the target tissue 220B can be readily removed and replaced. Modular configuration that allows the target tissue to be replaced can facilitate removal of old tissue and/or installing different tissue types and/or electrode arrays to simulate different anatomical environments. [0037] When an elongate vascular tool 240B is navigated so that its electrode lead 244B is brought in proximity with the target location provided by the target tissue 220B, impedance can be measured between electrodes in the lead 244B, for example an electrode positioned at the tip of the lead 244B and a return electrode also at or near the tip of the lead. When the lead 244B is in close proximity to the one or more of the electrodes 222B, 224B, and 226B, changes in the monitored impedance are used to determine the location of the lead. Likewise, as the lead is being implanted in the target tissue 220B, the amount of fixation can be determined by the impedance signal.

[0038] In additional to providing for the monitoring of electrical signals, anatomical path models of the present disclosure also provide for tactile feedback by using real or synthetic and realistic target tissue 220B. For example, tissue resistance, slippage, grab, and ease of implantation can be mimicked to give the physician or other operator a sense of the physical environment that may be encountered in a live procedure.

[0039] FIG. 3 is a block diagram that schematically indicates various components of an anatomical path model system 300 in accordance with aspects of the present disclosure. As discussed previously, an anatomical path model that includes target tissue at a target location is submerged in a bath of a solution that simulates a blood environment. The solution and path model may be contained in a tank, and a heater can be used to maintain the solution at a desired temperature. A catheter and lead delivery system is coupled to the path model from the outside of the tank, and is in turn connected to electrical signal monitoring tools such as may be utilized in an operating room environment. For example, the signal monitoring tools may detect and display the impedance between electrodes on the lead as it is navigated toward and around the target tissue. Other signals may also be monitored. The impedance changes in the presence of the one or more electrodes in or on the target tissue and/or simulated vasculature of the path model. These electrodes can be supplied with a simulated anatomical waveform as produced by a function generator from real or simulated electrophysiological data, for example as recorded from an electrocardiogram.

[0040] FIG. 4 is a flow chart exhibiting steps in methods of using anatomic path models in accordance with aspects of the present invention. An anatomical path model that includes surrogate, synthetic, or animal tissue positioned at a target location is submerged in a solution that simulates the electrical conductivity of a blood environment, and that optionally simulates the lubricity and viscosity of a blood environment. An elongate vascular device is used to navigate an implant lead to the target tissue. Electrical signals are monitored that indicate the positioning of the implant lead relative to the target tissue and/or other areas within the simulated vasculature. One or more electrodes or electrode arrays positioned within the path model, for example at or near the target tissue, may be used to generate electrophysiological signals, for instance in the form of a QRS wave. From the electrical signals monitored at the implant lead, it is determined whether the lead is at the target site. Upon reaching the target site, the lead may be implanted, or another implant-type procedure may be performed. Continued monitoring of the electrical signals can be used to determine the level of success of the implant procedure, for example the extent of fixation of the lead, a successful tunneling through the tissue, or a successful tissue ablation. In certain embodiments, imaging techniques such as fluoroscopy and intracardiac echocardiography (ICE) can be used along with the electrical signals to monitor and track the catheter-enabled procedure.

[0041] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

[0042] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware -based processing unit. Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0043] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

[0044] As used herein, the term “or” refers to an inclusive definition, for example, to mean “and/or” unless its context of usage clearly dictates otherwise. The term “and/or” refers to one or all of the listed elements or a combination of at least two of the listed elements.

[0045] As used herein, the phrases “at least one of’ and “one or more of’ followed by a list of elements refers to one or more of any of the elements listed or any combination of one or more of the elements listed.

[0046] As used herein, the terms “coupled” or “connected” refer to at least two elements being attached to each other either directly or indirectly. An indirect coupling may include one or more other elements between the at least two elements being attached. Further, in one or more embodiments, one element “on” another element may be directly or indirectly on and may include intermediate components or layers therebetween. Either term may be modified by “operatively” and “operably,” which may be used interchangeably, to describe that the coupling or connection is configured to allow the components to interact to carry out described or otherwise known functionality. For example, a controller may be operably coupled to a resistive heating element to allow the controller to provide an electrical current to the heating element.

[0047] As used herein, any term related to position or orientation, such as “proximal,” “distal,” “end,” “outer,” “inner,” and the like, refers to a relative position and does not limit the absolute orientation of an embodiment unless its context of usage clearly dictates otherwise. [0048] As used herein, the term “configured to” may be used interchangeably with the terms “adapted to” or “structured to” unless the content of this disclosure clearly dictates otherwise.

[0049] Th singular forms “a,” “an,” and “the” encompass embodiments having plural referents unless its context clearly dictates otherwise.

[0050] As used herein, “have,” “having,” “include,” “including,” “comprise,” “comprising” or the like are used in their open-ended sense, and generally mean “including, but not limited to.” It will be understood that “consisting essentially of,” “consisting of,” and the like are subsumed in “comprising,” and the like.

[0051] Reference to “one embodiment,” “an embodiment,” “certain embodiments,” or “some embodiments,” etc., means that a particular feature, configuration, composition, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. Thus, the appearances of such phrases in various places throughout are not necessarily referring to the same embodiment of the disclosure. Furthermore, the particular features, configurations, compositions, or characteristics may be combined in any suitable manner in one or more embodiments.

[0052] The words “preferred” and “preferably” refer to embodiments of the disclosure that may afford certain benefits, under certain circumstances. However, other embodiments may also be preferred, under the same or other circumstances.

Furthermore, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful and is not intended to exclude other embodiments from the scope of the disclosure.

[0053] The following examples are a non-limiting list of clauses in accordance with one or more techniques of this disclosure.

[0054] Example 1. An intravascular path model comprising: simulated vasculature leading to a target location, the simulated vasculature navigable by an elongate vascular tool; target tissue positioned at the target location and configured to provide realistic tactile feedback during a vascular procedure using the elongate vascular tool; and a fluid sufficiently approximating the conductivity of a blood environment such that when the simulated vasculature and target tissue are submerged in the fluid, electrical signals can be monitored indicative of a positioning of the elongate vascular implant tool within the simulated vasculature.

[0055] Example 2. The intravascular path model of Example 1, wherein the simulated vasculature is formed using additive manufacturing.

[0056] Example 3. The intravascular path model of Example 1, wherein the simulated vasculature is formed by a molding process.

[0057] Example 4. The intravascular path model of any of the preceding claims, wherein the target tissue is synthetic tissue.

[0058] Example 5. The intravascular path model of any of Examples 1 through 3, wherein the target tissue is animal tissue.

[0059] Example 6. The intravascular path model of any of the preceding claims, wherein the simulated vasculature replicates at least a portion of anatomy traversed to reach a ventricular septal wall or an atrial septal wall in the heart.

[0060] Example 7. The intravascular path model of Example 6, wherein the target tissue is synthetic or animal septal tissue.

[0061] Example 8. The intravascular path model of any of the preceding claims, further comprising one or more electrodes provided in or on the simulated vasculature and/or the target tissue.

[0062] Example 9. The intravascular path model of Example 8, wherein the one or more electrodes are configured to simulate a portion of a conductive pathway in the heart.

[0063] Example 10. The intravascular path model of Example 8, wherein the one or more electrodes are configured to provide simulated electrophysiological signals.

[0064] Example 11. The intravascular path model of Example 8, wherein the one or more electrodes include one or more sensors configured to provide feedback during a simulated ablation procedure.

[0065] Example 12. The intravascular path model of Example 8, wherein at least one of the one or more electrodes is located away from the target tissue to simulate a remotely located return electrode. [0066] Example 13. The intravascular path model of Example 12, wherein the simulated vasculature is porous to allow a conductive pathway through the fluid to the at least one of the one or more electrodes located away from the target tissue.

[0067] Example 14. The intravascular path model of any of the preceding claims, further comprising one or more wires arranged in the target tissue to provide a conductive path that is detectably altered when subjected to a successful ablation procedure.

[0068] Example 15. The intravascular path model of Example 10, wherein at least one of the one or more electrodes is positioned near the target location.

[0069] Example 16. The intravascular path model of Example 15, wherein the target location simulates an area of the heart, and wherein the area of the heart is determinable based on the simulated electrophysiological signals.

[0070] Example 17. The intravascular path model of Example 16, wherein the target location simulates a left bundle branch.

[0071] Example 18. The intravascular path model of Example 16, wherein the target location simulates a His bundle.

[0072] Example 19. The intravascular path model of Example 16, wherein the target location simulates an area of a ventricle wall.

[0073] Example 20. The intravascular path model of Example 16, wherein the target location simulates an area of an atrial wall.

[0074] Example 21. The intravascular path model of any of the preceding claims, wherein the target tissue is removable and replaceable without altering the simulated vasculature.

[0075] Example 22. The intravascular path model any of the preceding claims, wherein the simulated vasculature is configured as a plurality of modular portions that can be removed, replaced, combined, duplicated, repositioned, and reoriented to form different pathways. [0076] Example 23. The intravascular path model any of the preceding claims, wherein the elongate vascular tool is a catheter-enabled tool for use in an implant procedure, ablation procedure, or tunneling procedure.

[0077] Example 24. The intravascular path model any of the preceding claims, wherein the elongate vascular tool is configured for delivery without the use of catheters.

[0078] Example 25. The intravascular path model any of the preceding claims, wherein the fluid has a viscosity that mimics a blood environment.

[0079] Example 26. The intravascular path model any of the preceding claims, wherein the fluid has a lubricity that mimics a blood environment.

[0080] Example 27. The intravascular path model any of the preceding claims, wherein the vascular procedure includes implantation of a pacing lead or a leadless pacemaker.

[0081] Example 28. The intravascular path model any of the preceding claims, wherein the vascular procedure includes a tunneling procedure.

[0082] Example 29. The intravascular path model any of the preceding claims, wherein the vascular procedure includes an ablation procedure.

[0083] Example 30. A method for use with the intravascular path model of any of the preceding claims, the method comprising: navigating the elongate vascular tool through the simulated vasculature to the target tissue at the target site; monitoring one or more electrical signals indicative of a positioning of the elongate vascular tool; determining from the one or more electrical signals that the elongate vascular tool is positioned at the target site; and using the elongate vascular tool to perform the vascular procedure on the target tissue at the target site.

[0084] Example 31. The method of Example 30, wherein the vascular procedure is an ablation procedure.

[0085] Example 32. The method of Example 30, wherein the vascular procedure is a pacing lead implant procedure.

[0086] Example 33. The method of Example 30, wherein the vascular procedure is defibrillation lead implant procedure. [0087] Example 34. The method of Example 30, wherein the vascular procedure is leadless pacing device implant procedure.

[0088] Example 35. The method of Example 30, wherein the vascular procedure is a cutting or tunneling procedure.

Claims

WHAT IS CLAIMED:

1. An intravascular path model comprising: simulated vasculature leading to a target location, the simulated vasculature navigable by an elongate vascular tool; target tissue positioned at the target location and configured to provide realistic tactile feedback during a vascular procedure using the elongate vascular tool; and a fluid sufficiently approximating the conductivity of a blood environment such that when the simulated vasculature and target tissue are submerged in the fluid, electrical signals can be monitored indicative of a positioning of the elongate vascular implant tool within the simulated vasculature.

2. The intravascular path model of claim 1, wherein the simulated vasculature is formed using additive manufacturing or a molding process.

3. The intravascular path model of any of the preceding claims, wherein the target tissue is synthetic tissue or animal tissue.

4. The intravascular path model of any of the preceding claims, wherein the simulated vasculature replicates at least a portion of anatomy traversed to reach a ventricular septal wall or an atrial septal wall in the heart.

5. The intravascular path model of any of the preceding claims, further comprising one or more electrodes provided in or on the simulated vasculature and/or the target tissue, wherein the one or more electrodes are configured to simulate a portion of a conductive pathway in a heart, configured to provide simulated electrophysiological signals, or configured to provide feedback during a simulated ablation procedure

6. The intravascular path model of claim 5, wherein at least one of the one or more electrodes is located away from the target tissue to simulate a remotely located return electrode.

7. The intravascular path model of any of the preceding claims, further comprising one or more wires arranged in the target tissue to provide a conductive path that is detectably altered when subjected to a successful ablation procedure.

8. The intravascular path model of claim 5, wherein at least one of the one or more electrodes is positioned near the target location, the target location simulates an area of the heart, and wherein the area of the heart is determinable based on simulated electrophysiological signals.

9. The intravascular path model of claim 8, wherein the target location simulates a left bundle branch, a His bundle, an area of a ventricle wall, or an area of an atrial wall.

10. The intravascular path model of any of the preceding claims, wherein the target tissue is removable and replaceable without altering the simulated vasculature.

11. The intravascular path model any of the preceding claims, wherein the simulated vasculature is configured as a plurality of modular portions that can be removed, replaced, combined, duplicated, repositioned, and reoriented to form different pathways.

12. The intravascular path model any of the preceding claims, wherein the fluid has a viscosity that mimics a blood environment.

13. The intravascular path model any of the preceding claims, wherein the fluid has a lubricity that mimics a blood environment.

14. A method for use with the intravascular path model of any of the preceding claims, the method comprising: navigating the elongate vascular tool through the simulated vasculature to the target tissue at the target site; monitoring one or more electrical signals indicative of a positioning of the elongate vascular tool; determining from the one or more electrical signals that the elongate vascular tool is positioned at the target site; and using the elongate vascular tool to perform the vascular procedure on the target tissue at the target site.

15. The intravascular path model any of the preceding claims, wherein the vascular procedure includes implantation of a pacing lead or a leadless pacemaker, a tunneling procedure, a cutting procedure, an ablation procedure, a pacing lead implant procedure, a defibrillation lead implant procedure, a leadless pacing device implant procedure.