Delivery of electrically conductive nanomaterial
By employing telescoping catheter delivery assemblies to implant electrically conductive nanomaterials within the cardiac conduction system, the method addresses the challenge of delivering these materials to specific heart locations, thereby improving cardiac conduction.
Patent Information
- Application Number
- PCT/US2024/047931
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-09-25
- Filing Date
- 2024-09-23
- Publication Date
- 2025-04-03
AI Technical Summary
Current technologies lack effective methods for delivering electrically conductive nanomaterials to specific locations within the cardiac conduction system, such as the ventricular septum, to manage cardiac conduction disorders like left bundle branch blocks.
The use of telescoping catheter delivery assemblies, including a fixation catheter with a fixation element and a penetration element, to precisely position and implant electrically conductive nanomaterials, such as gel pellets, into the target location within the heart.
This approach enables the precise delivery and implantation of electrically conductive nanomaterials, improving impaired conductive pathways in the cardiac conduction system and potentially treating conditions like left bundle branch blocks.
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Figure US2024047931_03042025_PF_FP_ABST
Abstract
Description
DELIVERY OF ELECTRICALLY CONDUCTIVE NANOMATERIALRELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 540,221 filed on September 25, 2023, titled DELIVERY OF ELECTRICALLY CONDUCTIVE NANOMATERIAL, which is hereby incorporated by reference in its entirety.SUMMARY
[0002] The present disclosure is directed delivery of electrically conductive nanomaterials, and more specifically, systems, devices, and methods to deliver electrically conductive nanomaterial into a target location such as the ventricular septum to influence a patient’s cardiac conduction system.
[0003] Embodiments described herein are directed to illustrative systems, devices, and methods to influence the functioning of the cardiac conduction system of a patient by implanting electrically conductive nanomaterial into the patient’s vascular septum, for example, for managing cardiac conductive disorders such as left bundle branch blocks (LBB blocks). Generally, the illustrative systems, devices, and methods may be described as promoting conduction of signals in the patient’s heart by introducing electrically conductive nanomaterial to improve impaired conductive pathways of the cardiac conduction system.
[0004] The cardiac conduction system, like a “superhighway,” may be described as quickly conducting electrical pulses, whereas pacing cardiac muscle tissue may slowly conduct electrical pulses, like “traveling on a dirt road.” The cardiac conduction system includes an sinoatrial (SA) node 20, atrial internodal tracts 22, 23, 24 (i.e., an anterior internodal 22, a middle internodal 23, and a posterior internodal 24), an atrioventricular node (AV node) 26, a His bundle 28 (also known as the atrioventricular bundle or bundle of His), and bundle branches including a left bundle branch (LBB) 30 and a right bundlebranch (RBB) 32. FIG. 1 also shows an arch of aorta 34 and a Bachman’s bundle 36, all of which are shown in the anterior view of a frontal section of the patient’s heart 10 illustrated in FIG. 1.
[0005] The SA node 20, located at the junction of a superior vena cava 38 and a right atrium (RA) 12, is considered to be the natural pacemaker of the heart since it continuously and repeatedly emits electrical impulses. The electrical impulse spreads through muscles of the RA 12 to a left atrium (LA) 18 to cause synchronous contraction of the atria 12, 18. Electrical impulses are also carried through the atrial internodal tracts to the AV node 26 — the sole connection between the atria and the ventricles.
[0006] Conduction through tissue of the AV node 26 takes longer than through tissue of the atria 12, 18, resulting in a delay between atrial contraction and the start of ventricular contraction. An AV delay, which is the delay between atrial contraction and ventricular contraction, allows the atria to empty blood into the ventricles. Then, the valves between the atria and ventricles close before causing ventricular contraction via the branches 30, 32 of the bundle of His 28.
[0007] The His bundle 28 is located in a membranous atrioventricular septum near an annulus of the tricuspid valve 42, which is located between the RA 12 and a right ventricle (RV) 14. The His bundle 28 splits into the LBB 30 and RBB 32, which are formed of specialized fibers called “Purkinje fibers” 40. The Purkinje fibers 40 may be described as being able to rapidly conduct an action potential down an interventricular septal wall 50, spreading the depolarization wavefront quickly through the remaining ventricular myocardium, and producing a coordinated contraction of the ventricular muscle mass. The interventricular septal wall 50 may be described as including a right ventricular endocardium 52 and a left ventricular endocardium 54 separating the ventricular myocardium from a right ventricle (RV) 14 and a left ventricle (LV) 16, respectively.
[0008] The techniques of this disclosure generally relate to electrically conductive nanomaterials for implantation into a target location at, including, or proximate a portion of the cardiac conduction system, or an impairment in the cardiac conduction system, and to telescoping catheter delivery assemblies for implantation of electrically conductivenanomaterials in the target location. The target location may include the interventricular septal wall 50, for example. Electrically conductive nanomaterial may include electrically conductive nanomaterial gels or electrically conductive nanomaterial gel pellets, or a combination thereof. Electrically conductive nanomaterial may be delivered in the target location using various catheter delivery assemblies. Illustrative catheter delivery assemblies may include a fixation catheter and a penetration element, each of which may include a curved region. In one or more embodiments, the catheter delivery assemblies may facilitate perpendicular positioning of the electrically conductive nanomaterial into the target location.
[0009] One illustrative system may include a fixation catheter extending from a proximal fixation catheter end region to a distal fixation catheter end region and defining a fixation catheter lumen extending from the proximal fixation catheter end region to the distal fixation catheter end region. The distal fixation catheter end region may be positionable adjacent a target location. The fixation catheter may include a fixation element coupled to and extending from the distal fixation catheter end region to affix the distal fixation catheter end region to the target location. A penetration element may be disposable in and movable in the fixation catheter lumen to form an opening into the target location and to form an implantation channel extending from the opening into the target location. A pushing element may extend from a proximal pushing end region to a distal pushing end region which may be disposable in and movable in the fixation catheter lumen to move an electrically conductive nanomaterial gel pellet through the fixation catheter lumen and into the target location through the opening and into the implantation channel.
[0010] The target location may include an interventricular septal wall of a patient’s heart. The distal fixation catheter end region may be positionable adjacent an interventricular septal wall of a patient’s heart. The fixation element may be coupled to and extending from the distal fixation catheter end region to affix the distal fixation catheter end region to an interventricular septal wall of a patient’s heart. The penetration element may be disposable and movable in the fixation catheter lumen to form the opening through a right ventricular endocardium of an interventricular septal wall of a patient’s heart, and to form the implantation channel extending from the opening into the interventricular septal wall.JThe distal pushing end region may be disposable in and movable in the fixation catheter lumen to move the electrically conductive nanomaterial gel pellet through the fixation catheter lumen and into an interventricular septal wall of a patient’s heart, through the opening and into the implantation channel.
[0011] The fixation catheter may be disposable in and movable in a delivery catheter, or may be steerable. The fixation catheter may extend from the distal fixation catheter end region along a fixation axis and the distal fixation catheter end region of the fixation catheter may define a fixation curvature to position the fixation axis of the fixation element orthogonal to a plane defined by the target location.
[0012] The fixation element may include a helix, a double-helix, or a combination thereof. The fixation element may include an electrically conductive portion to map the target location. The fixation catheter may further include an electrode to map the target location, and the electrode may be coupled to the distal fixation catheter end region, or the fixation element, or both.
[0013] The penetration element may extend from a proximal penetration end region to a distal penetration end region, which may define a penetration curvature to form an implantation curvature in the implantation channel when the distal penetration end region extends beyond the opening in the target location. The penetration element may be steerable. The penetration element may include one or more of a penetration pellet, a guidewire, a steerable guidewire, a pre-formed guidewire, a stylet, or a combination of two or more thereof.
[0014] The pushing element may define a pushing element lumen, or a pushing element channel, or both, and the penetration element may be disposable in and movable in the pushing element lumen, or the pushing element channel, or both.
[0015] A guide element may be included, which extends from a proximal guide end region to a distal guide end region. The guide element may be disposable in and movable in the fixation catheter lumen to move into the target location through the opening. The electrically conductive nanomaterial gel pellet may be slidably disposable along the guide element to move along a path defined by the guide element. The electrically conductive nanomaterial gel pellet may slidably disposable along the penetration element to movealong a path defined by the penetration element. A guide pellet may be included, which is detectable by a medical imaging system. The guide pellet may be implantable through the opening. A depth measurement element may be included, which may be disposable at the proximal pushing end region of the pushing element to measure longitudinal movement of the pushing element within the fixation catheter lumen. The depth measurement element may include an outer tubular element defining a lumen and an inner tubular element fixedly disposable at the proximal fixation catheter end region of the fixation catheter. The outer tubular element may be fixedly disposable at the proximal pushing end region of the pushing element. The inner tubular element may be slidably disposable in the lumen of the outer tubular element.
[0016] One illustrative method may include delivering a fixation catheter to a target location. The target location may define an implantation site and the fixation catheter may extend from a proximal fixation catheter end region to a distal fixation catheter end region. The fixation catheter may define a fixation catheter lumen extending from the proximal fixation catheter end region to the distal fixation catheter end region, and the fixation catheter may include a fixation element coupled to and extending from the distal fixation catheter end region. The illustrative method may further include affixing the distal fixation catheter end region to the target location proximate the implantation site using the fixation element, providing a penetration element disposed in the fixation catheter lumen, moving the penetration element through the fixation catheter lumen to the target location to penetrate and form an opening into the target location and to form an implantation channel extending from the opening into the target location, providing an electrically conductive nanomaterial gel pellet disposed in the fixation catheter lumen, and providing a pushing element disposed in the fixation catheter lumen. The pushing element may extend from a proximal pushing end region to a distal pushing end region. The illustrative method may further include moving the pushing element through the fixation catheter lumen to push the electrically conductive nanomaterial gel pellet into the target location through the opening and into the implantation channel.
[0017] The target location may include an interventricular septal wall of a patient’s heart. Delivering the fixation catheter to the target location may include delivering the fixationcatheter to an interventricular septal wall of a patient’s heart. Affixing the distal fixation catheter end region to the target location may include affixing the distal fixation catheter end region to an interventricular septal wall of a patient’s heart. Moving the penetration element through the fixation catheter lumen to the target location to penetrate and form the opening into the target location and to form the implantation channel extending from the opening into the target location may include moving the penetration element through the fixation catheter lumen to an interventricular septal wall of a patient’s heart to penetrate and form the opening through a right ventricular endocardium of the interventricular septal wall and to form the implantation channel extending from the opening into the interventricular septal wall. Moving the pushing element through the fixation catheter lumen to push the electrically conductive nanomaterial gel pellet into the target location through the opening and into the implantation channel may include moving the pushing element through the fixation catheter lumen to push the electrically conductive nanomaterial gel pellet into an interventricular septal wall of a patient’s heart through the opening and into the implantation channel.
[0018] The illustrative method may further include unaffixing the distal fixation catheter end region from the target location, moving the distal fixation catheter end region along the target location and positioning the distal fixation catheter end region proximate an auxiliary implantation site defined by the target location, affixing the distal fixation catheter end region to the target location proximate the auxiliary implantation site using the fixation element, forming an auxiliary opening into the target location using the penetration element, forming an auxiliary implantation channel extending from the auxiliary opening into the target location using the penetration element, providing an auxiliary electrically conductive nanomaterial gel pellet disposed in the fixation catheter lumen, and moving the pushing element through the fixation catheter lumen to push the auxiliary electrically conductive nanomaterial gel pellet into the target location through the auxiliary opening and into the auxiliary implantation channel.
[0019] The target location may include an interventricular septal wall of a patient’s heart and forming the implantation channel may include deflecting the penetration elementalong a left ventricular endocardium of the interventricular septal wall proximate a left bundle branch toward or away from a bundle of His.
[0020] Delivering the fixation catheter to the target location may include providing a delivery catheter and moving the fixation catheter disposed in the delivery catheter through and along a lumen defined by the delivery catheter.
[0021] The illustrative method may further include mapping the target location, adjusting an orientation of the fixation catheter relative to the target location while the distal fixation catheter end region is affixed to the target location, and / or at least partially withdrawing the penetration element from the implantation channel before moving the pushing element through the fixation catheter lumen to push the electrically conductive nanomaterial gel pellet into the target location through the opening and into the implantation channel.
[0022] Forming the implantation channel may include forming a curvature in the implantation channel. At least a portion of the implantation channel may be non- orthogonal to a plane defined by the target location. Providing the electrically conductive nanomaterial gel pellet disposed in the fixation catheter lumen may include providing the electrically conductive nanomaterial gel pellet slidably disposed on the penetration element and movable along a path defined by the penetration element.
[0023] The illustrative method may further include moving a guide element disposed in the fixation catheter lumen through the fixation catheter lumen and into the target location through the opening and into the implantation channel. Providing the electrically conductive nanomaterial gel pellet disposed in the fixation catheter lumen may include slidably disposing the electrically conductive nanomaterial gel pellet on the guide element. Moving the pushing element through the fixation catheter lumen to push the electrically conductive nanomaterial gel pellet into the target location through the opening and into the implantation channel may include pushing the electrically conductive nanomaterial gel pellet along a path defined by the guide element.
[0024] Moving the pushing element through the fixation catheter lumen to push the electrically conductive nanomaterial gel pellet into the target location through the opening and into the implantation channel may include moving the electricallyconductive nanomaterial gel pellet along a path defined by the penetration element. Moving the pushing element through the fixation catheter lumen to push the electrically conductive nanomaterial gel pellet into the target location through the opening and into the implantation channel may include moving the pushing element through the fixation catheter lumen to push a plurality of electrically conductive nanomaterial gel pellets through the fixation catheter lumen and into the target location through the opening and into the implantation channel.
[0025] Another illustrative system may include a fixation catheter extending from a proximal fixation catheter end region to a distal fixation catheter end region, and defminga fixation catheter lumen extending from the proximal fixation catheter end region to the distal fixation catheter end region, which may be positionable adjacent a right ventricular endocardium of an interventricular septal wall of a patient's heart. The fixation catheter may include a fixation element coupled to and extending from the distal fixation catheter end region to affix the distal fixation catheter end region to right ventricular endocardium. A penetration element may be disposable in and movable in the fixation catheter lumen to form an opening through the right ventricular endocardium and to form an implantation channel extending from the opening into the interventricular septal wall. A pushing element may extend from a proximal pushing end region to a distal pushing end region. The distal pushing end region may be disposable in and movable in the fixation catheter lumen to move an electrically conductive nanomaterial gel pellet through the fixation catheter lumen and into the interventricular septal wall through the opening and into the implantation channel.
[0026] The above summary is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The figures and the detailed description below more particularly exemplify illustrative embodiments.BRIEF DESCRIPTION OF DRAWINGS
[0027] The discussion below refers to the following figures, wherein the same reference number may be used to identify the similar / same component in multiple figures. However, the use of a number to refer to a component in a given figure is not intended tolimit the component in another figure labeled with the same number. The figures are not necessarily to scale.
[0028] FIG. 1 is a cross-sectional view of the cardiac conduction system of a patient’s heart as one example of an environment for using the electrically conductive nanomaterial delivery systems and methods of the present disclosure.
[0029] FIG. 2 is a diagrammatic cross-sectional view of an illustrative system to deliver electrically conductive nanomaterial in the target location.
[0030] FIG. 3A is a perspective view of an illustrative depth measurement element for use with the system of FIG. 2.
[0031] FIG. 3B is a perspective view of an inner tubular element of the depth measurement element of FIG. 3 A.
[0032] FIG. 3C is a perspective view of an outer tubular element of the depth measurement element of FIG. 3 A.
[0033] FIG. 3D is a diagrammatic side view of the depth measurement element of FIG. 3A.
[0034] FIG. 4 is a block diagram of an illustrative method of delivering electrically conductive nanomaterial in the target location, e.g., that could be performed with the system of FIG. 2.
[0035] FIGS. 5A-5J are cross-sectional diagrams illustrating various stages or processes of implanting an electrically conductive nanomaterial gel pellet in the interventricular septal wall using an illustrative system according to aspects of the system of FIG. 2 and an illustrative method according to aspects of the method of FIG. 4.
[0036] FIGS. 6A-6I are cross-sectional diagrams illustrating various stages or processes of implanting an auxiliary, or second, electrically conductive nanomaterial gel pellet using the system of FIGS. 5A-5J and an illustrative method according to aspects of the method of FIG. 4.
[0037] FIGS. 7A-7I are cross-sectional diagrams illustrating various stages of implanting a third electrically conductive nanomaterial gel pellet in the interventricular septal wall using the system of FIGS. 5A-5J and an illustrative method according to aspects of themethod of FIG. 4 and including slidably disposing the third electrically conductive nanomaterial gel pellet on a guide element.
[0038] FIGS. 8A-8F and 9A-9F are cross-sectional diagrams illustrating various stages of implanting one or more electrically conductive nanomaterial gel pellets using an illustrative system according to aspects of the system of FIG. 2 and an illustrative method according to aspects of the method of FIG. 4 and including forming a curved implantation channel.
[0039] FIGS. 10A-10F are cross-sectional diagrams illustrating various stages of implanting one or more electrically conductive nanomaterial gel pellets using the system of FIGS. 8A-8F and an illustrative method according to aspects of the method of FIG. 4 and including deflecting the penetration element along the left ventricular endocardium.
[0040] FIGS. 11A-11D and 12A-12F are cross-sectional diagrams illustrating various stages of implanting one or more electrically conductive nanomaterial gel pellets using an illustrative system according to aspects of the system of FIG. 2 and illustrative methods according to aspects of the method of FIG. 4 and including adjusting an orientation of the fixation catheter relative to the target location.DETAILED DESCRIPTION
[0041] In the following detailed description of illustrative embodiments, reference is made to the accompanying figures of the drawings which form a part hereof, and in which are shown, by way of illustration, specific embodiments which may be practiced. It is to be understood that other embodiments may be utilized, and structural changes may be made without departing from (e.g., still falling within) the scope of the present disclosure.
[0042] Illustrative systems, devices, and methods shall be described with reference to FIGS. 1-12. It will be apparent to one skilled in the art that elements or processes from one embodiment may be used in combination with elements or processes of the other embodiments, and that the possible embodiments of such systems, devices, and methods using combinations of features set forth herein is not limited to the specific embodiments shown in the figures or described herein. Further, it will be recognized that theembodiments described herein may include elements that are not necessarily shown to scale. Still further, it will be recognized that timing of the processes and the size and shape of various elements herein may be modified but still fall within the scope of the present disclosure.
[0043] A diagrammatic view of an illustrative system 200 to deliver electrically conductive nanomaterial in or to a target location is shown in FIG. 2.
[0044] The target location may be described as a region, or portion, of tissue with which the system 200 may interact, or is configured to interact. For example, the target location may include tissue to which a fixation catheter may couple, or affix; tissue into which a penetration element may penetrate to form, or define, an implantation channel; and / or tissue into which electrically conductive nanomaterial may be implanted, as further described herein. The target location may include a surface through which a penetration element may penetrate to form, or define, an opening. More specifically, the target location may include tissue adjacent, along, or including at least a portion of the patient’s cardiac conduction system, such as the LBB 30 or an impairment in the patient’s cardiac conduction system, such as a LBB block. For example, the target location may be, or include, the interventricular septal wall 50 or a region, or portion, of the interventricular septal wall 50 to which a fixation catheter may couple, or affix, as further described herein. As another example, the target location may be, or include, a region of the interventricular wall 50 adjacent, along, or including the LBB 30, and the target location may further include the right ventricular endocardium 52 through which a penetration element may form, or define, an opening.
[0045] The system 200 may include a fixation catheter 210 extending from a proximal fixation catheter end region 212 to a distal fixation catheter end region 214. The fixation catheter 210 may define a fixation catheter lumen 218 extending from the proximal fixation catheter end region 212 to the distal fixation catheter end region 214. The distal fixation catheter end region 214 of the fixation catheter 210 may be navigable or deliverable to the target location. For example, the fixation catheter 210 may be navigable (e.g., movable, positionable, etc.) to the interventricular septal wall 50 via, or from, the right ventricle 14 of the patient’s heart 10. The distal fixation catheter endregion 214 may be navigable or deliverable to the target location using any suitable method, or technique. Suitable fixation catheter delivery methods may include using a steerable guidewire, a steerable stylet, or a steerable delivery catheter, as a few examples. Additionally, the fixation catheter 210 may be steerable so as to deliver the fixation catheter 210 to the target location. More specifically, the distal fixation catheter end region 214 may be positionable adjacent the target location. In an example, the distal fixation catheter end region 214 may be positionable adjacent the right ventricular endocardium 52 of the interventricular septal wall 50 of the patient’s heart 10.
[0046] The fixation catheter lumen 218 may define or have any suitable internal diameter. Suitable fixation catheter lumen 218 internal diameters may be selected based on compatibility with elements disposable and movable in the fixation catheter lumen 218 such as, for example, a penetration element 220, a pushing element 230, or an electrically conductive nanomaterial gel pellet 250, which will be described further herein. Suitable fixation catheter lumen 218 internal diameters may be between about 1 millimeter (mm) and about 3 mm. In one embodiment, the fixation catheter internal diameter is 1.45 mm. Additionally or alternatively, suitable fixation catheter inner diameters may include 0.5 mm or greater, 1 mm or greater, 1.5 mm or greater, 2 mm or greater, 2.5 mm or greater, or 3 mm or greater and / or 3.5 mm or less, 3 mm or less, 2.5 mm or less, 2 mm or less, 1.5 mm or less, or 1 mm or less. It will be understood in light of the present disclosure that any suitable fixation catheter lumen 218 internal diameter may be used and the disclosure is not limited in this regard.
[0047] Further, the fixation catheter 210 may have or define any suitable outer diameter. Suitable fixation catheter outer diameters may be selected based on compatibility with a delivery catheter 260 (as described further herein), such as, for example, an inner diameter defined by the delivery catheter 260, the internal diameter of the fixation catheter lumen 218, or the desired wall thickness of the fixation catheter 210 to provide structural rigidity, as a few examples. Suitable fixation catheter outer diameters may include between about 1.5 mm and about 6 mm. In one embodiment, the fixation catheter outer diameter is 2.4 mm. Additionally or alternatively, suitable fixation catheter outer diameters may include 1 mm or greater, 1.5 mm or greater, 2.5 mm or greater, 3 mm orgreater, 4 mm or greater, 5 mm or greater, or 6 mm or greater, and / or 7 mm or less, 6 mm or less, 5 mm or less, 4 mm or less, 3.5 mm or less, 2.5 mm or less, or 1.5 mm or less. It will be understood in light of the present disclosure that any suitable fixation catheter outer diameter may be used and the disclosure is not limited in this regard.
[0048] The fixation catheter 210 may include any suitable material or construction. Suitable fixation catheter materials and constructions may be selected based on durability, for example. Fixation catheter durability may be useful, for example, so the fixation catheter 210 may resist deformation, or degradation, and maintain functionality over the course of prolonged or repeated manipulations, or complex movements, of the fixation catheter 210 and / or elements disposable and movable within the fixation catheter lumen 218, as described further herein. Suitable fixation catheter constructions may include support structure, which may include a coil body (e.g., stainless steel coil, titanium coil, or an alloy coil such as a MP35N coil or a nitinol coil) or braided tubing (e.g., stainless steel braid, titanium braid, or an alloy braid, such as a MP35N braid or a nitinol braid), as examples. Suitable fixation catheter materials may include polyurethane polyamide, silicone, polyether ether ketone (PEEK), as examples. In general, the fixation catheter 210 may include (e.g., be formed of) an electrically insulative material. In some embodiments, the fixation catheter 210 include (e.g., be formed of) a semi-rigid or semiflexible material. In general, suitable fixation catheter materials may be capable of holding, or maintaining, a preformed shape in the absence of sufficient external forces and capable of flexing in response to sufficient lateral forces. For example, the material and construction of the fixation catheter 210 may allow the fixation catheter 210 to conform to the shape of a blood vessel or the delivery catheter 260 while advancing therethrough, and the fixation catheter 210 may revert to the preformed shape when advanced into a chamber of the patient’s heart 10. In other words, the fixation catheter 210 may include (e.g., be formed of) resilient material and construction such that it is deflectable but still be biased towards its original shape. The delivery catheter 260 may include (e.g., be formed of) any suitable material. In general, the delivery catheter may include (e.g., be formed of) an electrically insulative material. In some embodiments, the delivery catheter 260 may include (e.g., be formed of) a semi-rigid or semi-flexiblematerial. In general, a suitable delivery catheter material may be capable of holding a preformed shape in the absence of external forces and capable of flexing in response to sufficient lateral forces. For example, suitable delivery catheter materials may allow the delivery catheter to conform to the shape of a blood vessel while advancing therethrough while reverting to the preformed shape when advanced into a chamber of the patient’s heart 10. In other words, the delivery catheter 260 may include (e.g., be formed of) resilient material and construction such that it is deflectable but still be biased towards its original shape. It will be understood in light of the present disclosure that any suitable catheter materials or construction may be used for the fixation catheter 210 and deliver catheter 260 and the disclosure is not limited in this regard.
[0049] The fixation catheter 210 may include a fixation element 216 to affix, couple, or attach the distal fixation catheter end region 214 to the target location. For example, the fixation catheter 210 may include the fixation element 216 to affix, couple, or attach the distal fixation catheter end region 214 to the right ventricular endocardium 52 of the interventricular septal wall 50 of the patient’s heart 10. The fixation element 216 may be coupled to and extend from the distal fixation catheter end region 214. The fixation element 216 may extend from the distal fixation catheter end region 214 along a fixation axis 217.
[0050] In at least one embodiment, the fixation element 216 may be freely rotatable relative to the delivery catheter 260. For example, fixation catheter 210 may be configured to transfer torque from the proximal catheter end region 212 to the distal catheter end region. In other words, rotation of the proximal catheter end region 212 (for example, a portion of the proximal catheter end region 212 outside the patient) within the delivery catheter lumen 268 may result in corresponding rotation of the distal catheter end region 214 and, in turn, rotation of the fixation element 216. More specifically, the fixation element 216 may be freely rotatable relative to a distal delivery catheter end region 264 (as described further herein), which may facilitate certain types of fixation for implantation. For example, a rotating motion may be used to affix the distal fixation catheter end region 214 to the target location using a fixation element that responds to a rotating motion.
[0051] In one or more embodiments according to aspects of the illustrative system 200 shown in FIG. 2, the fixation element 216 includes or is a helix configured to be able to screw into or out of the target location in response to rotation of the fixation catheter 210. Additionally or alternatively to a helix, the fixation element 216 may include any suitable geometry, or construction, to affix, couple, or attach the distal fixation catheter end region 214 to the target location. Non-limiting examples of suitable fixation elements may include a helix, a double-helix, or retractable tines, as a few examples. Suitable fixation elements may be selected based on durability or re-usability, as examples. Fixation element durability and re-usability may be useful, for example, so the fixation element 216 may resist deformation, or degradation, and maintain functionality over the course of multiple cycles of affixing to and releasing from the target location. In other words, durability and re-usability may be useful to resist degradation and improve functionality throughout prolonged or repeated manipulations, or complex movements, of the fixation element 216, as described further herein. As another example, durability may be useful to keep the distal fixation catheter end region 214 affixed to the target location during the method, or portions of the method, such as while forming an implantation channel or implanting the electrically conductive nanomaterial in the target location, as will be described further herein. Additionally or alternatively, the fixation element 216 may define a lumen, or channel, through which elements of the illustrative system 200 (e.g., the electrically conductive nanomaterial, the penetration element, or the guide element), may be movable.
[0052] The fixation element 216 may include a conductor or be formed of a conductive material. Some or all of the fixation element 216 may be coated in an electrically insulative material. Non-limiting examples of electrically insulative materials include polyamide and polytetrafluoroethylene (PTFE). Some or all of the fixation element 216 may be coated in a conductive material. A non-limiting example of a conductive material includes titanium nitride (TiN). In some embodiments, the fixation element 216 may include a proximal portion, a distal portion, or tip, including a coating of conductive material, and a body including a coating of electrically insulative material. The proximal portion, or tip, may be uncoated. In some embodiments, the fixation element 216 may beused for electrical mapping while delivering the fixation catheter 210 or implanting the electrically conductive nanomaterial. The fixation element 216 may be operably coupled to a cardiac signal analyzer, for example, via one or more conductors extending through the fixation catheter 210.
[0053] In some embodiments according to aspects of the illustrative system 200, the distal fixation catheter end region 214 may define a fixation curvature for suitable orientation of the fixation axis 217 relative to the target location. For example, the distal fixation catheter end region 214 may define a fixation curvature to orient the fixation axis 217 orthogonal, or generally perpendicular, to a plane defined by the interventricular septal wall 50.
[0054] The fixation catheter 210 may include a fixation catheter electrode (not expressly shown in FIG. 2), for example, to map the target location. The fixation catheter electrode may be coupled to the distal fixation catheter end region 214, or to the fixation element 216, or both.
[0055] In some embodiments, the system 200 may include the penetration element 220 to form, or create, an opening in the target location. For example, the system 200 may include the penetration element 220 to form, or create, an opening in the interventricular septal wall 50 through the right ventricular endocardium 52. Additionally, the penetration element 220 may be configured to form an implantation channel in the target location (for example, in the ventricular myocardial tissue) extending from the opening and into the interventricular septal wall 50. The penetration element 220 may extend from a proximal penetration end region 222 to a distal penetration end region 224. For example, and as shown in FIG. 2, the penetration element 220 may be, or include, a penetration guidewire, or stylet.
[0056] In one or more embodiments, the penetration element 220 may be slidably disposable in and movable in the fixation catheter lumen 218 while the fixation catheter 210 is fixedly coupled to the target location to form, or create, the opening in the target location and, further, to form, or create, the implantation channel extending from the opening into the target location. In particular, while the fixation catheter 210 is fixedly coupled, or affixed, to the target location, the penetration element 220 may be movablerelative to the fixation catheter 210 — and relative to the target location to which the fixation catheter 210 is fixedly coupled — while the penetration element 220 is disposed in the fixation catheter lumen 218 to form, or create, the opening in the target location and to form, or create, the implantation channel extending from the opening into the target location.
[0057] The penetration element 220 may include any suitable geometry, or construction, to form an opening into the target location, or to form an implantation channel in the target location, or both. The penetration element 220 may be a guidewire, a steerable guidewire, a pre-formed guidewire, or a stylet, for a few examples.
[0058] Other examples of suitable penetration element geometries, or constructions, may be a penetration pellet. In embodiments including a penetration pellet, the penetration pellet may be configured to be moved through the fixation catheter lumen 218 and into the target location to form the opening, or to form the implantation channel, or both. It will be understood in light of the present disclosure that any suitable penetration element geometry, or construction, may be used and the disclosure is not limited in this regard.
[0059] The penetration element 220 may be steerable (for example, the penetration element may be a steerable guidewire, or stylet). In embodiments including the penetration element 220 that is steerable, the distal penetration end region 224 may be configured, such as pre-formed or steerable, to define a penetration curvature. The penetration element 220 may be disposable in and movable in the fixation catheter lumen 218.
[0060] In embodiments according to the present disclosure, the system 200 may include an electrically conductive nanomaterial, such as the electrically conductive nanomaterial gel pellet 250, as shown in FIG. 2. The electrically conductive nanomaterial may be disposable in and movable in the fixation catheter lumen 218 and, in particular, the electrically conductive nanomaterial may be movable from the proximal fixation catheter end region 212 to the distal fixation catheter end region 214 and out of the opening at the distal fixation catheter end region 214. The electrically conductive nanomaterial may be slidably disposable along the penetration element 220 to move along a path defined by the penetration element 220.
[0061] The electrically conductive nanomaterial may include any suitable electrically conductive nanomaterials. Suitable electrically conductive nanomaterials may be selected based on biocompatibility, conductivity, or biodegradability, as examples. Suitable electrically conductive nanomaterials may include, for example, silver nanotubes, silver nanowires, gold nanotubes, gold nanowires, carbon nanotubes, platinum nanotubes, platinum nanowires, titanium nanotubes, titanium nanowires, or alloy nanomaterials such as MP35N nanowires, or MP35N nanotubes.
[0062] The electrically conductive nanomaterial may include a carrier, or may be suspended in a gel. The electrically conductive nanomaterial may include any suitable carrier. Suitable carriers may be selected based on biocompatibility, biodegradability, hardness, elongation, material compatibility (e.g., with the electrically conductive nanomaterial), or viscosity, as examples. Suitable carriers may include, for example, sugar, gelatin, poly caprolactone (PCL), polylactic acid (PLA), or collagen hydrogel. It will be understood in light of the present disclosure that any suitable carrier may be used and the disclosure is not limited in this regard.
[0063] In embodiments including electrically conductive nanomaterial gel pellets, the gel pellets may have or define any suitable outer diameter. Suitable electrically conductive nanomaterial gel pellet outer diameters may be selected based on penetration element diameter, implantation channel diameter, fixation catheter diameter, target location dimensions, or desired quantity of electrically conductive nanomaterial to be delivered, as examples. Suitable electrically conductive nanomaterial gel pellet outer diameters may include about 100 micrometers (um), as an example. For further examples, suitable electrically conductive nanomaterial gel pellet outer diameters may include between about 0.5 mm and about 3 mm, or between about 0.8 mm and about 2.5 mm. Additionally or alternatively, suitable electrically conductive nanomaterial gel pellet diameters may include 0.25 mm or greater, 0.5 mm or greater, 0.8 mm or greater, 1 mm or greater, 1.5 mm or greater, 2 mm or greater, 2.5 mm or greater, or 3 mm or greater, and / or 3.5 mm or less, 3 mm or less, 2.5 mm or less, 2 mm or less, 1.5 mm or less, 1 mm or less, or 0.8 mm or less, or 0.5 mm or less. It will be understood in light of the present disclosure that anysuitable electrically conductive nanomaterial gel pellet diameter may be used and the disclosure is not limited in this regard.
[0064] In embodiments including electrically conductive nanomaterial gel pellets, the gel pellets may have any suitable length. Suitable electrically conductive nanomaterial gel pellet lengths may be selected based on desired quantity of electrically conductive nanomaterial to be delivered, or dimensions of the target location (e.g., thickness of the interventricular septum), as examples. Suitable electrically conductive nanomaterial gel pellet lengths may be between about 2 mm and about 12 mm, for example. In one embodiment, the electrically conductive nanomaterial gel pellet length is 3 mm. Additionally or alternatively, suitable electrically conductive nanomaterial gel pellet lengths may be 2 mm or greater, 3 mm or greater, 5 mm or greater, 7 mm or greater, 9 mm or greater, or 12 mm or greater, and / or 15 mm or less, 12 mm or less, 10 mm or less, 6 mm or less, 4 mm or less, 3 mm or less, or 2 mm or less. It will be understood in light of the present disclosure that any suitable electrically conductive nanomaterial gel pellet length may be used and the disclosure is not limited in this regard.
[0065] In at least one embodiment, the system 200 may include a guide element 240 (shown in FIG. 2 as a guidewire). The guide element 240 may extend from a proximal guide end region 242 to a distal guide end region 244, as in a guidewire. The guide element 240 may be disposable in and movable in the fixation catheter lumen 218, for example, to move through the opening in the target location and into the implantation channel extending from the opening into the target location. Similar to the penetration element 220, the electrically conductive nanomaterial gel pellet 250 may be slidably disposable along the guide element 240 to move along a path defined by the guide element 240.
[0066] The guide element 240 may include any suitable guide element materials. Suitable guide element materials may be selected based on material compatibility with the electrically conductive nanomaterial, biocompatibility, pushability (i.e., the ability to transmit pushing force from the proximal end to the distal end), stiffness, hardness, or flexibility, as some examples. Suitable guide element materials may include, for example, stainless steel, tungsten, or alloys such as MP35N or nitinol. In some embodiments, theguidewire may include a coating, such as a PTFE coating or a hydrophilic coating, which may be useful, for example, to reduce friction (e.g., friction between the guidewire and the fixation catheter or between the guidewire and the electrically conductive nanomaterial). It will be understood in light of the present disclosure that any suitable guide element material may be used and the disclosure is not limited in this regard.
[0067] The guide element 240 may have or define any suitable diameter. Suitable guide element diameters may be selected based on compatibility with the electrically conductive nanomateral, compatibility with the internal diameter of the fixation catheter lumen, stiffness, pushability, or desired curvature of the implantation channel, for example. Suitable guide element diameters may be, for example, between about 0.3 mm and about 1 mm. In one embodiment, the guide element diameter is 0.035 mm. Additionally or alternatively, suitable guide element diameters may include 0.2 mm or greater, 0.3 mm or greater, 0.4 mm or greater, 0.5 mm or greater, 0.6 mm or greater, 0.7 mm or greater, 0.8 mm or greater, or 1 mm or greater, and / or 1.2 mm or less, 1 mm or less, 0.9 mm or less, 0.7 mm or less, 0.5 mm or less, or 0.3 mm or less. It will be understood in light of the present disclosure that any suitable guide element diameter may be used and the disclosure is not limited in this regard.
[0068] Additionally or alternatively to the guide element 240, the system 200 may include a guide pellet 246, which may be detectable by a medical imaging system. The guide pellet 246 may be disposable in and movable in the fixation catheter lumen 218, for example, to move through the fixation catheter lumen 218 and into the interventricular septal wall 50 through the opening in the right ventricular endocardium 52 and into the implantation channel formed by the penetration element 220. In other words, the guide pellet 246 may be implantable through the opening in the target location and into the implantation channel extending from the opening in the target location and into the target location. Additionally or alternatively, the guide pellet 246 may be configured to be moved through the fixation catheter lumen 218 and into the interventricular septal wall 50 to form the opening, or to form the implantation channel, or both.
[0069] The guide pellet 246 may include any suitable materials. Suitable guide pellet materials may be selected based on material compatibility with the electricallyconductive nanomaterial, biocompatibility, detectability by medical imaging systems, or mechanical properties, as some examples. Suitable guide pellet materials may include, for example, platinum, silver, gold, tantalum, tungsten, or alloys such as MP35N.Additionally or alternatively, the guide pellet may include a coating, such as a PTFE coating or a hydrophilic coating. It will be understood in light of the present disclosure that any suitable guide pellet material may be used and the disclosure is not limited in this regard.
[0070] The guide pellet 246 may have any suitable geometry, or configuration. Suitable guide pellet geometries, or configurations, may be selected based on compatibility with the penetration element (e.g., to slidably dispose the guide pellet 246 on the penetration element 220), compatibility with the guide element (e.g., to slidably dispose the guide pellet 246 on the guide element 240), biocompatibility, or compatibility with the electrically conductive nanomaterial gel, for example. As another example, suitable guide pellet geometries, or configurations, may be selected to indicate a direction, or orientation, of the guide pellet 246 — such as, for example, within the target location — while using medical imaging, such as imaging anterior to posterior, dorsal to ventral, and / or cephalad to caudal. Suitable guide pellet geometries, or configurations, may include conical, frustoconical, pyramidal, or ogival, as examples. The guide pellet may define a lumen to be slidably disposed on the guide element or the penetration element. It will be understood in light of the present disclosure that any suitable guide pellet geometry, or configuration may be used and the disclosure is not limited in this regard.
[0071] In one or more embodiments, the system 200 may include the pushing element 230 extending from a proximal pushing end region 232 to a distal pushing end region 234. At least a portion of the pushing element 230 may be disposable in and movable in the fixation catheter lumen 218. For example, the distal pushing end region 234 may be disposable in and movable in the fixation catheter lumen 218. The pushing element 230 may be configured to move the electrically conductive nanomaterial (for example, the electrically conductive nanomaterial gel pellet 250) through the fixation catheter lumen 218 and into the target location through the opening and into the implantation channel. More specifically, the distal pushing end region 234 may push, or move, the electricallyconductive nanomaterial gel pellet 250 along the fixation catheter lumen 218 (and optionally along the path defined by the penetration element 220 or along the path defined by the guide element 240) from the proximal fixation catheter end region 212 of the fixation catheter 210 to the distal fixation catheter end region 214, through the opening in the distal fixation catheter end region 214, through the opening in the target location, and into the implantation channel extending from the opening in the target location into the target location. For example, the distal pushing end region 234 may push the electrically conductive nanomaterial gel pellet 250 through the opening in the distal fixation catheter end region 214, through the opening in the right ventricular endocardium 52, and into the implantation channel formed by the penetration element 220.
[0072] The pushing element 230 may define a pushing element lumen, or channel, (not expressly shown in FIG. 2) extending from the proximal pushing end region 232 to the distal pushing end region 234. At least a portion of the penetration element 220 may be disposable in and movable in the pushing element lumen, or channel. Additionally or alternatively, at least a portion of the guide element 240 may be disposable in and movable in the pushing element lumen, or channel.
[0073] The pushing element 230 may include any suitable pushing element materials. Suitable pushing element materials may be selected based on material compatibility with the electrically conductive nanomaterial, biocompatibility, material compatibility with the fixation catheter, material compatibility with the guide element, material compatibility with the penetration element, or mechanical properties such as stiffness, as some examples. Suitable pushing element materials may include, for example, PTFE, polyether block amide (PEBA), PEEK, polyamide, polyurethane, nylon, or fluorinated ethylene propylene. In some embodiments, suitable pushing element materials may include braided materials. It will be understood in light of the present disclosure that any pushing element material may be used and the disclosure is not limited in this regard.
[0074] The pushing element 230 may have any suitable outer diameter. Suitable pushing element outer diameters may be selected based on compatibility with the electrically conductive nanomaterial, compatibility with the fixation catheter (e.g., to be movablydisposed within the fixation catheter lumen), or mechanical properties such as kink resistance and pushability, for example. Suitable pushing element outer diameters may include, for example, between about 1 mm and about 3 mm. In one embodiment, the pushing element outer diameter is 1.2 mm. Additionally or alternatively, suitable pushing element outer diameters may include greater than 0.8 mm, greater than 1 mm, greater than 1.5 mm, greater than 2 mm, greater than 2.5 mm, or greater than 3 mm, and / or less than 3.5 mm, less than 3 mm, less than 2.5 mm, less than 2 mm, less than 1.5 mm, or less than 1 mm. It will be understood in light of the present disclosure that any suitable pushing element outer diameter may be used and the disclosure is not limited in this regard.
[0075] The pushing element 230 may have any suitable inner diameter. Suitable pushing element inner diameters may be selected based on compatibility with the electrically conductive nanomaterial (e.g., smaller than an outer diameter of the electrically conductive nanomaterial gel pellet 250), compatibility with the guide element (e.g., to fit the guide element 240 within the lumen of the pushing element 230), or mechanical properties such as kink resistance and pushability, for example. Suitable pushing element inner diameters may include, for example, between about 0.3 mm and about 1 mm. In one embodiment, the pushing element inner diameter is 0.4 mm. Additionally or alternatively, suitable pushing element inner diameters may include greater than 0.25 mm, greater than 0.35 mm, greater than 0.4 mm, greater than 0.5 mm, greater than 0.7 mm, greater than 0.9 mm, or greater than 1 mm, and / or less than 1.5 mm, less than 1.2 mm, less than 1 mm, less than 0.8 mm, less than 0.6 mm, less than 0.4 mm, or less than 0.3 mm. It will be understood in light of the present disclosure that any suitable pushing element inner diameter may be used and the disclosure is not limited in this regard.
[0076] In one or more embodiments according to the present disclosure, the system 200 may include the delivery catheter 260 extending from a proximal delivery end region 262 to the distal delivery catheter end region 264. The delivery catheter 260 may define a delivery catheter lumen 268. The fixation catheter 210 may be disposable in and movable in the delivery catheter lumen 268 to deliver, or to navigate, the fixation catheter 210 to the target location. For example, the fixation catheter 210 may be disposable in andmovable in the delivery catheter lumen 268 to deliver, or to navigate, the fixation catheter 210 to the interventricular septal wall 50 via the right ventricle 14 of the patient’s heart 10. One or both of the fixation catheter 210 and the delivery catheter 260 may have a curved region, or a region defining a curvature, which may facilitate perpendicular positioning of the fixation axis 217 relative to or into the target location, as will be described further herein.
[0077] In some embodiments, the system 200 may include a depth measurement element 300, which may be disposable, or couplable, at the proximal pushing end region 232 of the pushing element 230. A diagrammatic view of the depth measurement element 300 is shown in FIG. 3A. The depth measurement element 300 may be configured to measure longitudinal movement of an elongate element movably disposed within the fixation catheter lumen 218, such as the pushing element 230, the penetration element 220, or the guide element 240. The depth measurement element 300 may include an inner tubular element 310 and an outer tubular element 320. The inner tubular element 310 may be movably disposable in the lumen of the outer tubular element 320. Additionally or alternatively, the inner tubular element 310 may be rotatably disposable in a lumen of the outer tubular element 320.
[0078] In one or more embodiments, the depth measurement element 300 may include the inner tubular element 310. A perspective view of the inner tubular element 310 is shown in FIG. 3B. The inner tubular element 310 may extend from a proximal inner end region 312 to a distal inner end region 314. The inner tubular element 310 may be fixedly disposable, or couplable, at the proximal fixation catheter end region 212 of the fixation catheter 210. The inner tubular element 310 may define, or have, an inner element slot 318 extending from the proximal inner end region 312 to the distal inner end region 314.
[0079] Any suitable mechanism, or fastener, may be used to fixedly dispose, or fixedly couple, the inner tubular element 310 to the proximal fixation catheter end region 212. In an example, and as shown in FIG. 3B, the inner tubular element 310 may include a luer lock 316 at the distal inner end region 314. The luer lock 316 may be fixedly and releasably couplable to the proximal fixation catheter end region 212 of the fixation catheter 210 to fixedly and releasably dispose, or couple, the inner tubular element 310 tothe proximal fixation catheter end region 212. Suitable mechanisms, or fasteners, to fixedly dispose the inner tubular element 310 at the proximal fixation catheter end region 212 may additionally or alternatively include a set screw or a needle hub, as two examples. It will be understood in light of the present disclosure that any suitable mechanism, or fastener, may be used and the disclosure is not limited in this regard.
[0080] The inner tubular element 310 may be formed of any suitable material. Suitable inner tubular element materials may include PEEK, polymethyl methacrylate (PMMA), polyvinyl chloride (PVC), polypropylene, polycarbonate, acrylonitrile butadiene styrene (ABS), polyethylene terephthalate glycol (PETG), polyethylene, as just some examples. It will be understood in light of the present disclosure that any inner tubular element material may be used and the disclosure is not limited in this regard.
[0081] In some embodiments, and as shown in FIG. 3A, the depth measurement element 300 includes the outer tubular element 320. A perspective view of the outer tubular element 320 is shown in FIG. 3C. The outer tubular element 320 may extend from a proximal outer end region 322 to a distal outer end region 324. The outer tubular element 320 may be fixedly disposable, or couplable, at the proximal end region of an elongate element movably disposed within the fixation catheter lumen 218. For example, the outer tubular element 320 may be fixedly disposable at, or fixedly coupled to, the proximal pushing end region 232 of the pushing element 230. As further examples, the outer tubular element 320 may be fixedly disposable at, or fixedly coupled to, the proximal penetration end region 222 of the penetration element 220 or the proximal guide end region 242 of the guide element 240. The outer tubular element 320 may define, or have, an outer element slot 328 extending from the proximal outer end region 322 to the distal outer end region 324.
[0082] The outer tubular element 320 may additionally be slidably disposed at the proximal end region of an elongate element that is movably disposed within the fixation catheter lumen 218. In other words, the elongate element may be movably disposable within the lumen of the outer tubular element 320.
[0083] Any suitable mechanism, or fastener, may be used to fixedly dispose, or couple, the outer tubular element 320 at the proximal end region of an elongate element that ismovably disposed within the fixation catheter lumen 218. For example, the outer tubular element 320 may include a set screw mechanism 326 at the proximal outer end region 322. Suitable mechanisms, or fasteners, to fixedly dispose the outer tubular element 320 at the proximal end region of the elongate element may additionally or alternatively include a collet mechanism, a spring mechanisms, or a cam mechanism, as a few examples. It will be understood in light of the present disclosure that any suitable mechanism, or fastener, may be used and the disclosure is not limited in this regard.
[0084] The outer tubular element 320 may be formed of any suitable material. Suitable outer tubular element materials may include PEEK, polymethyl methacrylate (PMMA), polyvinyl chloride (PVC), polypropylene, polycarbonate, acrylonitrile butadiene styrene (ABS), polyethylene terephthalate glycol (PETG), polyethylene, as a few examples. It will be understood in light of the present disclosure that any outer tubular element material may be used and the disclosure is not limited in this regard.
[0085] In some embodiments, alignment between the inner element slot 318 of the inner tubular element 310 and the outer element slot 328 of the outer tubular element 320 may be adjusted by rotation of the inner tubular element 310 within the outer tubular element 320. Fixedly disposing, or coupling, the outer tubular element 320 at the proximal end region of an elongate element that is movably disposed within the fixation catheter lumen 218 may include aligning the inner element slot 318 and the outer element slot 328 (as shown in FIG. 3 A) by rotation of the inner tubular element 310 within the outer tubular element 320 (or rotation of the outer tubular element 320 about the inner tubular element 310). Disposing, or coupling, the outer tubular element 320 at the proximal end region of the elongate element that is movably disposed within the fixation catheter lumen 218 may include moving the elongate element through the outer element slot 328 into the lumen of the outer tubular element 320 and through the inner element slot 318 into the lumen of the inner tubular element 310. The inner element slot 318 and the outer element slot 328 may be unaligned by rotating the inner tubular element 310 within the lumen of the outer tubular element 320 or by rotating the outer tubular element 320 about the inner tubular element 310, which may secure the elongate element within the depth measurement element 300.
[0086] In one or more embodiments, the depth measurement element 300 may measure longitudinal movement of an elongate element movably disposed within the fixation catheter lumen 218. When the depth measurement element 300 is disposed at, or coupled to, the proximal end region of the elongate element, longitudinal movement of the outer tubular element 320 relative to the inner tubular element 310 may be representative of longitudinal movement of the elongate element relative to the fixation catheter 210. Further, the inner tubular element 310 may include gradations for measuring, or marking, longitudinal movement of the outer tubular element 320 relative to the inner tubular element 310, which may be representative of longitudinal movement of the elongate element relative to the fixation catheter 210.
[0087] A diagrammatic side view of the depth measurement element 300 is shown in FIG. 3D.
[0088] A block diagram of an illustrative method 400 of delivering the electrically conductive nanomaterial in or to the target location is shown in FIG. 4. Various stages of the method 400 may be performed, for example, using the system 200 shown in FIG. 2.
[0089] In some embodiments, the method 400 may optionally include mapping 410 the target location. In some embodiments, the mapping 410 may include 3D mapping the target location. The mapping 410 may include using any suitable mapping methods, or techniques. Suitable mapping methods, or techniques may be selected based on factors such as patient anatomy or the target location, as two examples. Suitable mapping methods may include electrical mapping, for example. In illustrative embodiments, the mapping 410 may include using the system 200. For example, an electrically conductive fixation element may be used during implantation, for example, to facilitate mapping 410 and to identify an implantation site for the electrically conductive nanomaterial (e.g., the electrically conductive nanomaterial gel pellet 250) at the target location.
[0090] The method 400 may further include delivering the fixation catheter 414 (e.g., the fixation catheter 210) to the target location. Delivering the fixation catheter 414 to the target location may include, for example, delivering the fixation catheter to the interventricular septal wall 50 of the patient’s heart 10. Delivering the fixation catheter 414 may include using any suitable delivery methods, or techniques. Suitable fixationcatheter delivery methods may be selected based on compatibility with the fixation catheter, compatibility with patient anatomy, compatibility with the target location, or compatibility with the medical imaging system, as just two examples. Suitable fixation catheter delivery methods may include using a guidewire, using a stylet, using a delivery catheter, using a steerable guidewire, using a steerable stylet, using a steerable delivery catheter, using pre-formed guidewire, using a pre-formed stylet, or using a pre-formed delivery catheter, as examples. For another example, the fixation catheter may be guided through an incision in a left or right pectoral and guided through the superior vena cava 38 (e.g., via a jugular vein) to the RA 12. The fixation catheter may be further guided through the RA 12 to the RV 14. Delivering the fixation catheter 414 may include pushing and / or rotating the fixation catheter to position a fixation element (e.g., the fixation element 216), or a fixation axis (e.g., the fixation axis 217) of the fixation element orthogonal, or perpendicular, to a plane defined by the target location, such as a plane defined by the interventricular septal wall 50, or a plane extending through the implantation axis 58.
[0091] In at least one embodiment, delivering the fixation catheter 414 optionally includes delivering the delivery catheter 412 (e.g., the delivery catheter 260), such as a steerable delivery catheter, which may be further used to deliver the fixation catheter (e.g., the fixation catheter 210) to the target location. For example, the delivery catheter may be guided through an incision in a left or right pectoral and guided through the superior vena cava 38 (e.g., via a jugular vein) to the RA 12. The delivery catheter may be further guided through the RA 12 to the RV 14. Delivering the delivery catheter 412 may include pushing and / or rotating the delivery catheter to position a distal delivery catheter end region (e.g., the distal delivery catheter end region 264) proximate the target location, such as proximate the interventricular septal wall 50. More specifically, the delivery catheter may be pushed and / or rotated to position an opening in the distal delivery catheter end region proximate, or toward, the target location.
[0092] In some embodiments including the delivery catheter, delivering the fixation catheter 414 may include advancing, or moving, the fixation catheter through, or along, a lumen of the delivery catheter (e.g., the delivery catheter lumen 268) toward the targetlocation. The fixation catheter may be advanced through, or along, the delivery catheter lumen after positioning the distal delivery catheter end region. Alternatively or alternatively, the fixation catheter may be advanced through, or along, the delivery catheter lumen while positioning the distal delivery catheter end region. In other words, advancing the fixation catheter through the delivery catheter lumen may coincide with, or at least partially coincide with, positioning the distal delivery catheter end region proximate the target location.
[0093] Diagrams illustrating various stages or processes of implanting electrically conductive nanomaterial (e.g., the electrically conductive nanomaterial gel pellet 250) in an illustrative target location, such as the interventricular septal wall 50, as shown using an illustrative system 500 according to aspects of the system 200 of FIG. 2 and aspects of the method 400 of FIG. 4 are shown in FIGS. 5A-12F. For example, a diagrammatic view of delivering the fixation catheter 414 using the system 500 is shown in FIG. 5A.
[0094] The illustrative system 500 includes a fixation catheter 510 extending from a proximal fixation catheter end region 512 to a distal fixation catheter end region 514. The fixation catheter 510 may define a fixation catheter lumen 518 extending from the proximal fixation catheter end region 512 to the distal fixation catheter end region 514. The fixation catheter 510 includes a fixation element 516 coupled to and extending from the distal fixation catheter end region 514.
[0095] The system 500 may include a delivery catheter 560 extending from a proximal delivery catheter end region 562 to a distal delivery catheter end region 564. The delivery catheter 560 may define a delivery catheter lumen 568. In embodiments according to aspects of the system 500, at least a portion of the fixation catheter 510 may be disposable in and movable in the delivery catheter lumen 568.
[0096] The interventricular septal wall 50 may define an implantation site 80. The implantation site 80 may be adjacent or including a portion of the cardiac conduction system, such as the LBB 30. As an example, the implantation site 80 may be adjacent an impairment in the cardiac conduction system, such as a LBB block. The implantation site 80 may be adjacent or intersected by an implantation axis 58, which that may be defined by or extend along a portion of the cardiac conduction system (e.g., the LBB 30). Inparticular, the implantation axis 58 may be defined by, intersect with, or along an impairment in the cardiac conduction system, such as a LBB block.
[0097] As shown in FIG. 5 A, the fixation catheter 510 may be delivered to the interventricular septal wall 50, and more specifically to the right ventricular endocardium 52, of the patient’s heart 10 via the RV 14. In other words, delivering the fixation catheter 414 may include positioning the fixation catheter 510 adjacent the right ventricular endocardium 52.
[0098] In embodiments including the delivery catheter 560, the fixation catheter 510 may be disposed in and movable in the delivery catheter lumen 568 for delivery to the target location. In other words, delivering the fixation catheter 414 to the interventricular septal wall 50 may include providing the delivery catheter 560 and slidably disposing the fixation catheter 510 in the delivery catheter lumen 568. Delivering the fixation catheter 414 may include moving the fixation catheter 510 through the delivery catheter lumen 568 and positioning the distal fixation catheter end region 514 proximate the interventricular septal wall 50.
[0099] In at least one embodiment, the method 400 includes affixing 416 a distal fixation catheter end region (e.g., the distal fixation catheter end region 214) of the fixation catheter to the target location (for example, to the interventricular septal wall 50, and more specifically to the right ventricular endocardium 52) proximate the implantation site using the fixation element (e.g., the fixation element 216). A diagrammatic example of affixing 416 the distal fixation catheter end region using the illustrative system 500 is shown in FIGS. 5B and 5C. Affixing 416 may include positioning the fixation element 516 adjacent the target location or, more specifically, positioning the fixation element 516 proximate the implantation site 80. In embodiments including the delivery catheter 560, affixing 416 may include moving the fixation catheter 510 through the delivery catheter lumen 568 to advance the distal fixation catheter end region 514 and the fixation element 516 toward the target location. The distal fixation catheter end region 514 may be affixed to the target location, for example, by rotating the fixation element 516 to screw the fixation element 516 into the target location. For example, the fixation catheter 510 may be rotated within the delivery catheter 560, thus rotating the fixation element516 to screw the fixation element into the target location. More specifically, the entire fixation catheter 510 may be rotated within the delivery catheter 560, to rotate the fixation element 516 and to screw the fixation element 516 into the interventricular septal wall 50.
[0100] The fixation element 516 may extend from the distal fixation catheter end region 514 along a fixation axis 517. The distal fixation catheter end region 514 of the fixation catheter 510 may include a curved fixation catheter region 519, which may facilitate affixing 416 the distal fixation catheter end region by orienting the fixation axis 517 orthogonal, or perpendicular, to a plane defined by the target location, such as a plane defined by the interventricular septal wall 50, or a plane extending through the implantation axis 58. For example, the fixation catheter 510 may be generally straight, while the curved fixation catheter region 519 may be capable of holding a preformed shape (e.g., forming, or defining, a curvature) in the absence of external forces and capable of flexing in response to sufficient lateral forces. More specifically, the curved fixation catheter region 519 may conform to the shape of a blood vessel while advancing therethrough, while reverting to the preformed shape defining a curvature when advanced into a chamber of the patient’s heart 10. As another example, the curved fixation catheter region 519 may conform to the shape of the delivery catheter lumen 568 while advancing therethrough, and revert to the preformed shape, including the curvature, when advanced beyond an opening in the distal delivery catheter end region 564.
[0101] In some embodiments including the delivery catheter 560, the distal delivery end region of the delivery catheter 560 may include a curved delivery catheter region 569, which may facilitate affixing 416 the distal fixation catheter end region by directing movement of the fixation element 516 toward the target location, such as toward the right ventricular endocardium 52, as the fixation catheter 510 moves within the delivery catheter 560. For example, the delivery catheter 560 may be generally straight, while the curved delivery catheter region 569 may be capable of holding a preformed shape (e.g., forming, or defining, a curvature) in the absence of external forces and capable of flexing in response to sufficient lateral forces. More specifically, the curved delivery catheter region 569 may conform to the shape of a blood vessel while advancing therethrough,while reverting to the preformed shape defining a curvature when advanced into a chamber of the patient’s heart 10.
[0102] In one or more embodiments, the method 400 includes providing a penetration element 420 (e.g., the penetration element 220) disposed in the fixation catheter lumen (e.g., the fixation catheter lumen 218). A diagrammatic example of providing the penetration element 420 using the illustrative system 500 is shown in FIG. 5D. A penetration element 520, shown in FIG. 5D having an elongate body extending from a proximal penetration end region 522 to a distal penetration end region 524, may be disposed in and movable in the fixation catheter lumen 518 of the fixation catheter 510. Providing the penetration element 420 may include disposing the penetration element 520 in the fixation catheter lumen 518 and moving the distal penetration end region 524 through and along the fixation catheter lumen 518 toward the distal fixation catheter end region 514. Providing the penetration element 420 may include advancing the distal penetration end region 524 toward the target location, or toward the implantation site 80, via the fixation catheter lumen 518.
[0103] In at least one embodiment, the penetration element may include a penetration pellet. In some embodiments including the penetration pellet, providing the penetration element 420 may include disposing the penetration pellet in the fixation catheter lumen 518. Providing the penetration pellet may include moving the penetration pellet through and along the fixation catheter lumen 518 and advancing the penetration pellet toward the target location, or toward the implantation site 80, more specifically. Moving, or pushing, the penetration pellet may include, for example, using a pushing element (e.g., the pushing element 230), as will be described further herein.
[0104] In some embodiments, the method 400 may include forming an implantation channel 422 in the target location using the penetration element (e.g., the penetration element 220). A diagrammatic example of forming the implantation channel 422 using the illustrative system 500 is shown in FIG. 5E. Forming the implantation channel 422 may include moving the penetration element 520 through the fixation catheter lumen 518 to the target location, such as to the interventricular septal wall 50, or more specifically to the right ventricular endocardium 52. Forming the implantation channel 422 may includeinserting the penetration element 520 through the target location to penetrate and form an opening 60 in the target location. For example, and as shown in FIG. 5E, the penetration element 520 may advance, or penetrate, through the right ventricular endocardium 52 to form an opening through the right ventricular endocardium 52 and may advance, or penetrate, into the interventricular septal wall 50 to form an implantation channel 70 in the interventricular septal wall 50. In other words, the penetration element 520 may extend, or advance, from the opening 60 into the interventricular septal wall 50 to form the implantation channel 70 at or in the implantation site 80. The implantation channel 70 may extend from the opening 60 in the right ventricular endocardium 52 and into the interventricular septal wall 50.
[0105] In some embodiments including the penetration pellet, forming the implantation channel 422 in the target location may include moving the penetration pellet through and along the fixation catheter lumen 518 to the target location. For example, forming the implantation channel 422 in the interventricular septal wall 50 with the penetration pellet may include inserting, or pushing, the penetration pellet through the right ventricular endocardium 52 to form the opening 60 in the interventricular septal wall 50. The penetration pellet may advance, or penetrate, into the interventricular septal wall 50 to form the implantation channel 52 extending from the opening 60 and into the interventricular septal wall 50. Inserting, or pushing, the penetration pellet may include, for example, using the pushing element (e.g., the pushing element 230), as will be described further herein.
[0106] The implantation channel 70 may have or define any suitable geometry or orientation. For example, the implantation channel 70 may be orthogonal, or generally perpendicular, to the implantation axis 58, to a plane defined by the target location, or to the interventricular septal wall 50, as shown in FIG. 5E. For additional examples of suitable implantation channel geometries or orientations, the implantation channel 70, or at least a portion of the implantation channel 70 may be non-orthogonal, or generally non-perpendicular (including, for example, parallel or generally parallel), to the plane defined by the target location or parallel to the plane defined by the target location. For still further examples of suitable implantation channel geometries or orientations, theimplantation channel may include one or more portions intersecting, extending along, or proximate to the implantation axis 58. The implantation channel may extend along the implantation axis 58 toward or away from the bundle of His 28. As yet another example of suitable implantation channel geometries or orientations, the implantation channel may include one or more portions intersecting, extending along, or proximate a portion of the cardiac conduction system, such as the LBB 30, or intersecting, extending along, or proximate an impairment in the cardiac conduction system, such as a LBB block.
[0107] The implantation channel 70 may have or define any suitable depth. Implantation channel depth may be described as a dimension of the implantation channel 70 measured along an axis orthogonal, or generally perpendicular, to a surface of the target location, such as the surface of the right ventricular endocardium 52 (that is, an interface between the right ventricular endocardium 52 and the right ventricle 14). Suitable implantation channel depths may be selected based on characteristics of the target location, such as characteristics of the patient’s heart, which may include, for example, a location, or depth, of a portion of the cardiac conduction system (e.g., a location, or depth, of the LBB 30) or a location, or depth, of an impairment in the cardiac conduction system (e.g., a location, or depth, of a LBB block). Suitable implantation channel depths may include between about 2 mm and about 6 mm or between about 2 mm and about 15 mm, for example. Additionally or alternatively, suitable implantation channel depths may include 1 mm or greater, 2 mm or greater, 4 mm or greater, 5 mm or greater, 7 mm or greater, 9 mm or greater, 11 mm or greater, 13 mm or greater, or 15 mm or greater, and / or 16 mm or less, 14 mm or less, 12 mm or less, 10 mm or less, 8 mm or less, 6 mm or less, 4 mm or less, or 2 mm or less. It will be understood in light of the present disclosure that any suitable implantation channel depth may be used such that it does not puncture through the target location, such as through the interventricular wall 50 and beyond the left ventricular endocardium 54, and the disclosure is not limited in this regard.
[0108] The implantation channel 70 may have any suitable length. Implantation channel length may be described as the longest dimension of the implantation channel 70. Implantation channel length may be linear or non-linear. Implantation channel length and implantation channel depth may be equal, for example, when the implantation channel 70extends linearly from the opening 60 and into the target location and extends parallel to the axis orthogonal, or generally perpendicular, to the surface of the target location, as described herein with respect to FIGS. 5A-7I.
[0109] Implantation channel length or implantation depth may be measured, for example, using the depth measurement element 300 described herein. In an example, the outer tubular element 320 may be fixedly disposed at, or fixedly coupled to, the proximal penetration end region 522 after moving the penetration element 520 through and along the fixation catheter lumen 518 to the target location. When the outer tubular element 320 is fixedly disposed at, or fixedly coupled to, the proximal penetration end region 522, movement of the penetration element 520 to form the opening and from the opening 60 into the implantation channel 70 may be measured, or represented, by movement of the outer tubular element 320 relative to the inner tubular element 330, representing longitudinal movement of the penetration element 520 within the fixation catheter 510.
[0110] In one or more embodiments, the method 400 may include providing an electrically conductive nanomaterial 428 (e.g., the electrically conductive nanomaterial gel pellet 250), which may be disposed in the fixation catheter lumen (e.g., the fixation catheter lumen 218). A diagrammatic example of providing the electrically conductive nanomaterial 428 using the illustrative system 500 is shown in FIG. 5F. Providing the electrically conductive nanomaterial 428 may include disposing an electrically conductive nanomaterial gel pellet 550 in the fixation catheter lumen 518. Additionally or alternatively, providing the electrically conductive nanomaterial 428 may include providing a plurality of electrically conductive nanomaterial gel pellets, or disposing a plurality of electrically conductive nanomaterial gel pellets in the fixation catheter lumen 518. The electrically conductive nanomaterial gel pellet 550 may be disposed in and movable in and along the fixation catheter lumen 518.
[0111] In some embodiments, providing the electrically conductive nanomaterial 428 optionally includes providing the electrically conductive nanomaterial slidably disposed on a guidewire 426 (e.g., the penetration element 220 or the guide element 240). As shown in FIG. 5F, the electrically conductive nanomaterial gel pellet 550 may be slidablydisposed on the penetration element 520. The electrically conductive nanomaterial gel pellet 550 may be movable along a path defined by the penetration element 520.
[0112] In some embodiments, and as illustrated in FIG. 5F, the method 400 optionally includes providing a guide pellet (e.g., the guide pellet 246). A guide pellet 546 may be disposed in and movable in the fixation catheter lumen 518 of the fixation catheter 510. The guide pellet 546 may be slidably disposed on a guidewire (e.g., the penetration element 220 or the guide element 240). As shown in FIG. 5F, the guide pellet 546 may be slidably disposed on the penetration element 520. The guide pellet 546 may be movable along a path defined by the penetration element 520.
[0113] In one or more embodiments, the method 400 may include providing a pushing element (e.g., the pushing element 230), which may be disposed in the fixation catheter lumen (e.g., the fixation catheter lumen 218) of the fixation catheter (e.g., the fixation catheter 210). A diagrammatic example of providing a pushing element 530 of the illustrative system 500 is shown in FIG. 5F. Providing the pushing element may include disposing the pushing element 530 in the fixation catheter lumen 518. The pushing element 530 may be disposed in and movable in and along the fixation catheter lumen 518. The pushing element 530 may extend from a proximal pushing end region 532 to a distal pushing end region 534.
[0114] In at least one embodiment, the method 400 may include implanting the electrically conductive nanomaterial 430 (e.g., the electrically conductive nanomaterial gel pellet 250) into the target location. A diagrammatic example of implanting the electrically conductive nanomaterial gel pellet 550 of the illustrative system 500 is shown in FIG. 5G. Implanting the electrically conductive nanomaterial 430 may include moving the pushing element 530 through the fixation catheter lumen 518 to push the electrically conductive nanomaterial into the target location through the opening 60 and into the implantation channel 70. Implanting the electrically conductive nanomaterial 430 may include moving the distal pushing end region 534 at least partially into the target location through the opening 60, which may include moving the distal pushing end region 534 at least partially into the implantation channel 70. As an example, and as shown in FIG. 5G, the distal pushing end region 534 may move into the interventricular septal wall 50 topush the electrically conductive nanomaterial gel pellet 550 an implantation depth from the opening 60 into the implantation channel 70.
[0115] In one or more embodiments, implanting the electrically conductive nanomaterial 430 may include implanting a plurality of electrically conductive nanomaterial gel pellets into the implantation channel. In other words, implanting the electrically conductive nanomaterial 430 may include moving the pushing element through the fixation catheter lumen to push a plurality of electrically conductive nanomaterial gel pellets through the fixation catheter lumen and into the target location through the opening and into the implantation channel.
[0116] In some embodiments including slidably disposing the electrically conductive nanomaterial on the guidewire 426, implanting the electrically conductive nanomaterial into the implantation channel may include moving the electrically conductive nanomaterial along the path defined by the penetration element and into the implantation channel. For example, as shown in FIG. 5G, implanting the electrically conductive nanomaterial 430 may include moving the pushing element 530 through and along the fixation catheter lumen 518 to push the electrically conductive nanomaterial gel pellet 550 into the interventricular septal wall 50 through the opening 60 and into the implantation channel 70, which may include moving the electrically conductive nanomaterial gel pellet 550 along the path defined by the penetration element 520.
[0117] The electrically conductive nanomaterial may be implanted into the target location adjacent or along a portion of the cardiac conduction system, such as the LBB 30. For example, the electrically conductive nanomaterial may be implanted adjacent or along an impairment in the cardiac conduction system, such as a LBB block. Implanting the electrically conductive nanomaterial adjacent or along a LBB block may be useful to promote conduction of signals in the patient’s heart 10 by improving impaired conductive pathways of the patient’s cardiac conduction system.
[0118] In one or more embodiments, the method 400 may include withdrawing a guidewire 432. A diagrammatic example of withdrawing the penetration element 520 of the illustrative system 500 is shown in FIG. 5H.
[0119] In some embodiments, withdrawing the guidewire 432 may occur after implanting the electrically conductive nanomaterial 430. For example, and ss shown in FIG. 5H, the penetration element 520 may be withdrawn after the electrically conductive nanomaterial gel pellet 550 has been implanted in the interventricular septal wall 50. Withdrawing the guidewire 432 after implanting the electrically conductive nanomaterial 430 slidably disposed thereon may be useful, for example, so that the electrically conductive nanomaterial may be moved along the path defined by the penetration element 520 until implantation in the target location is complete. Additionally or alternatively, withdrawing the guidewire 432 may occur before implanting the electrically conductive nanomaterial 430. Withdrawing the guidewire 432 before implanting the electrically conductive nanomaterial 430 may be useful, for example, so that the size and shape of the implantation channel (e g., the implantation channel 70) may be maintained. Additionally or alternatively, withdrawing the guidewire 432 may coincide with or at least partially coincide with implanting the electrically conductive nanomaterial 430.
[0120] In at least one embodiment, the method 400 may include withdrawing the pushing element from the target location. A diagrammatic example of withdrawing the pushing element 530 of the illustrative system 500 is shown in FIG. 51. The distal pushing end region 534 of the pushing element 530 may be withdrawn, or removed, from the implantation channel 70 in the target location and through the opening 60, leaving the electrically conductive nanomaterial gel pellet 550 implanted in the implantation channel 70. Withdrawing the pushing element 530 may additionally or alternatively include moving the distal pushing end region 534 through the fixation catheter lumen 518 toward the proximal fixation catheter end region 512 and away from the target location.
[0121] In one or more embodiments, the method 400 may include unaffixing the fixation catheter 434 from the target location. A diagrammatic example of unaffixing the fixation catheter 510 of the illustrative system 500 from the interventricular septal wall 50 is shown in FIG. 5J. The distal fixation catheter end region 514 may be unaffixed, or removed, from the interventricular septal wall 50, for example, by rotating the fixation element 516 in the opposite direction that it was rotated for affixing 416 the distal fixation catheter end region to the target location.
[0122] In some embodiments, one or more aspects of the method 400 may be repeatable. In an example, aspects of the method 400 may be repeated to implant additional electrically conductive nanomaterial (e.g., one or more additional electrically conductive nanomaterial gel pellets) into the target location. In one or more embodiments of the method 400 that include including implanting additional electrically conductive nanomaterial, the electrically conductive nanomaterial (e.g., the electrically conductive nanomaterial gel pellet 250 or the electrically conductive nanomaterial gel pellet 550) may be described relative to the additional electrically conductive nanomaterial, for example, as a first electrically conductive nanomaterial, as a primary electrically conductive nanomaterial, or as an initial electrically conductive nanomaterial. It will be understood in light of the present disclosure that, as used in this specification and the appended claims, reference to numbers of electrically conductive nanomaterial (e.g., a first electrically conductive nanomaterial) is merely for the purpose of distinguishing between electrically conductive nanomaterial, and does not necessarily limit the number of electrically conductive nanomaterials.
[0123] Repeatable aspects of the method 400 may include, for example, affixing 416, or re-affixing, the distal fixation catheter end region of the fixation catheter to the target location using the fixation element. Each additional implanting the electrically conductive nanomaterial 430 may include adjusting the orientation of the fixation catheter 418 (e.g., using the fixation catheter 510, using the delivery catheter 560, etc.), providing the penetration element 420 (or another penetration element), forming an implantation channel 422, providing electrically conductive nanomaterial 428, providing the electrically conductive nanomaterial slidably disposed on a guidewire 426, implanting the electrically conductive nanomaterial 430, withdrawing a guidewire 432, or a combination of two or more thereof.
[0124] Implanting additional electrically conductive nanomaterial may include forming or defining additional implantation sites in the target location. Additional implantation sites may be adjacent, including, or along a portion of the cardiac conduction system, such as adjacent, including, or along the LBB 30. For example, additional implantation sites may be adjacent, including, or along an impairment in the cardiac conductionsystem, such as adjacent, including, or along a LBB block. Additional implantation sites may each be adjacent, including, or along an implantation axis, such as the implantation axis 58. Likewise, implanting additional electrically conductive nanomaterial may include forming additional openings in the target location and may include forming additional implantation channels.
[0125] In some embodiments including additional implantation sites, the implantation site 80 may be described relative to the additional implantation sites, for example, as a first implantation site, as a primary implantation site, or as an initial implantation site. It will be understood in light of the present disclosure that, as used in this specification and the appended claims, reference to numbers of implantation sites (e.g., a first implantation site) is merely for the purpose of distinguishing between implantation sites, and does not necessarily limit the number of implantation sites.
[0126] Likewise, in some embodiments including additional openings, the opening 60 may be described relative to the additional openings, for example, as a first opening, as a primary opening, or as an initial opening. It will be understood in light of the present disclosure that, as used in this specification and the appended claims, reference to numbers of openings (e.g., a first opening) is merely for the purpose of distinguishing between openings, and does not necessarily limit the number of openings.
[0127] Similarly, in some embodiments including additional implantation channels, the implantation channel 70 may be described relative to the additional implantation channels, for example, as a first implantation channel, as a primary implantation channel, or as an initial implantation channel. It will be understood in light of the present disclosure that, as used in this specification and the appended claims, reference to numbers of implantation channels (e g., a first implantation channel) is merely for the purpose of distinguishing between implantation channels, and does not necessarily limit the number of implantation channels.
[0128] In one or more embodiments, the method 400 may include moving the distal fixation catheter end region 436 along the target location. A diagrammatic example of moving the distal fixation catheter end region 514 of the illustrative system 500 along the interventricular septal wall 50 is shown in FIGS. 6A and 6B. The distal fixation catheterend region 514 of the fixation catheter 510 may be moved away, or separated, from the surface of the target location. Separating the distal fixation catheter end region 514 from the target location, may be useful, for example, to avoid contact between the fixation element 516 and tissue of the target location while moving the distal fixation catheter end region 436.
[0129] In some embodiments including the delivery catheter 560, moving the distal fixation catheter end region 514 along the target location may include moving the fixation catheter 510 within the delivery catheter lumen 568. The fixation element 516 may be at least partially surrounded by the delivery catheter 560 while moving the distal fixation catheter end region 514 along the target location.
[0130] In at least one embodiment, the method 400 may include positioning, or repositioning, the distal fixation catheter end region proximate an auxiliary, or second, implantation site defined by the target location. Positioning, or repositioning, the distal fixation catheter end region proximate the auxiliary implantation site may be consistent with one or more aspects of delivering the fixation catheter 414 to the first implantation site. For example, the delivery catheter 560 may be moved and positioned to deliver the fixation catheter 510 to the target location. A diagrammatic example of positioning, or repositioning, the distal fixation catheter end region 514 of the illustrative system 500 proximate an auxiliary implantation site 82 is shown in FIG. 6B. The distal fixation catheter end region 514 may be moved along the right ventricular endocardium 52 and toward the auxiliary implantation site 82.
[0131] The auxiliary implantation site 82 may be proximate or intersecting the implantation axis 58. Relative to the implantation site 80, the auxiliary implantation site 82 may be along the implantation axis 58 away from the bundle of His 28, as shown in FIG. 6B. In some embodiments, the auxiliary implantation site 82 may be along the implantation axis 58 toward the bundle of His 28. The auxiliary implantation site 82 may additionally or alternatively be described, for example, as a second, secondary, or subsequent implantation site.
[0132] In some embodiments including the delivery catheter 560, positioning the distal fixation catheter end region 514 proximate the auxiliary implantation site 82 may includemoving the fixation catheter 510 through the delivery catheter lumen 568 to advance the distal fixation catheter end region 514 and the fixation element 516 toward the target location or toward the auxiliary implantation site 82.
[0133] In one or more embodiments, the method 400 may include repeating affixing 416, or re-affixing, the distal fixation catheter end region to the target location, which may include affixing, or re-affixing, the distal fixation catheter end region to the target location proximate the auxiliary implantation site using the fixation element. A diagrammatic example of affixing the distal fixation catheter end region 514 of the illustrative system 500 to the interventricular septal wall 50 proximate the auxiliary implantation site 82 is shown in FIG. 6C. The distal fixation catheter end region 514 may be affixed to the right ventricular endocardium 52 proximate the auxiliary implantation site 82, for example, by rotating the fixation element 516 to screw the fixation element 516 into the right ventricular endocardium 52.
[0134] In some embodiments, the method 400 may include repeating forming the implantation channel 422 in the target location using the penetration element, such as forming, or creating, an auxiliary, or second, opening in the target location using the penetration element and forming, or creating, an auxiliary, or second, implantation channel extending from the auxiliary opening into the target location using the penetration element. A diagrammatic example of forming an auxiliary implantation channel 72 in the interventricular septal wall 50 using the penetration element 520 of the illustrative system 500 is shown in FIG. 6D. Forming the auxiliary implantation channel 72 may include moving the penetration element 520 through the fixation catheter lumen 518 to the target location. Forming the auxiliary implantation channel 72 may include inserting distal penetration end region 524 into the target location to penetrate and form an auxiliary opening 62 in the target location. As shown in FIG. 6D, the distal penetration end region 524 may advance, or penetrate, through the right ventricular endocardium 52 and into the interventricular septal wall 50. In other words, the penetration element 520 may extend from the auxiliary opening 62 into the target location to form the auxiliary implantation channel 72. The auxiliary implantation channel 72 may extend from the auxiliary opening 62 in the target location and into the target location.
[0135] In at least one embodiment, the method 400 may include withdrawing the guidewire 432, which may optionally include withdrawing the penetration element 424 from the implantation channel (e.g., the implantation channel 70 or the auxiliary implantation channel 72) before implanting the electrically conductive nanomaterial into the implantation channel. In other words, the method 400 may optionally include withdrawing the penetration element 424 or at least partially withdrawing the penetration element from the implantation channel before moving the pushing element through the fixation catheter lumen to push the electrically conductive nanomaterialinto the target location through the opening and into the implantation channel. A diagrammatic example of withdrawing the distal penetration end region 524 from the auxiliary implantation channel 72 is shown in FIGS. 6E and 6F. The distal penetration end region 524 may be withdrawn from the auxiliary implantation channel 72 and through the auxiliary opening 62 in the target location. Withdrawing the distal penetration end region 524 from the target location may be described as leaving the auxiliary implantation channel 72 ready for implantation of electrically conductive nanomaterial. The penetration element 520 may be further withdrawn from the distal fixation catheter end region 514, as shown in FIG. 6F.
[0136] In one or more embodiments, the method 400 may include providing the electrically conductive nanomaterial 428, or repeating providing the electrically conductive nanomaterial 428, disposed in the fixation catheter lumen, such as providing an auxiliary, or second, electrically conductive nanomaterial (e.g., an electrically conductive nanomaterial gel pellet) disposed in the fixation catheter lumen. A diagrammatic example of providing an auxiliary electrically conductive nanomaterial gel pellet 552 disposed in the fixation catheter lumen 518 of the illustrative system 500 is shown in FIG. 6G.
[0137] In one or more embodiments, the method 400 may include implanting the electrically conductive nanomaterial 430, or repeating implanting the electrically conductive nanomaterial 430, such as implanting the auxiliary electrically conductive nanomaterial gel pellet 552. Implanting the electrically conductive nanomaterial 430 may include moving the pushing element through and along the fixation catheter lumen topush the auxiliary, or second, electrically conductive nanomaterial (e.g., an electrically conductive nanomaterial gel pellet) into the target location through the auxiliary, or second, opening and into the auxiliary, or second, implantation channel. A diagrammatic example of implanting the auxiliary electrically conductive nanomaterial gel pellet 552 by moving the pushing element 530 of the illustrative system 500 through the fixation catheter lumen 518 toward the distal fixation catheter end region 514 to push the auxiliary electrically conductive nanomaterial gel pellet 552 into the interventricular septal wall 50 through the auxiliary opening 62 and into the auxiliary implantation channel 72 is shown in FIGS. 6H and 61.
[0138] In some embodiments, the method 400 may include providing the electrically conductive nanomaterial slidably disposed on a guidewire 426, or repeating providing the electrically conductive nanomaterial slidably disposed on a guidewire 426, which may include slidably disposing the electrically conductive nanomaterial (e.g., the electrically conductive nanomaterial gel pellet 250, or the auxiliary electrically conductive nanomaterial gel pellet 552) on a guide element (e.g., the guide element 240). A diagrammatic example of various stages of the method 400 including slidably disposing a third electrically conductive nanomaterial gel pellet 553 of the illustrative system 500 on a guide element 540 is shown in FIGS. 7A-7I.
[0139] In one or more embodiments, the method 400 may include affixing 416, or repeating affixing 416, the distal fixation catheter end region to the target location, such as affixing, or re-affixing, using the fixation element, the distal fixation catheter end region to the target location proximate a third implantation site 83 defined by the target location. A diagrammatic example of affixing the distal fixation catheter end region 514 of the illustrative system 500 to the interventricular septal wall 50 proximate the third implantation site 83 is shown in FIG. 7A.
[0140] In at least one embodiment, the method 400 may include forming the implantation channel 422, or repeating forming the implantation channel 422, in the target location using the penetration element, such as forming, or creating, a third opening 63 in the target location using the penetration element and forming a third implantation channel 73 extending from the third opening 63 into the target location using the penetrationelement. A diagrammatic example of forming the third implantation channel 73 using the penetration element 520 of the illustrative system 500 is shown in FIG. 7B.
[0141] In one or more embodiments, the method 400 may include withdrawing the penetration element 424, or repeating withdrawing the penetration element 424, from the implantation channel to pre-form the implantation channel. A diagrammatic example of withdrawing the distal penetration end region 524 of the illustrative system 500 from the third implantation channel 73 is shown in FIGS. 7C and 7D. The penetration element 520 may be withdrawn from the distal fixation catheter end region 514, as shown in FIG. 7D.
[0142] In some embodiments, the method 400 may include moving a guide element (e.g., the guide element 240) through the opening and into the implantation channel. A diagrammatic example of moving the guide element 540 of the illustrative system 500 through the third opening 63 and into the third implantation channel 73 is shown in FIGS. 7E and 7F. The guide element 540 may be disposed in the fixation catheter lumen 518. The guide element 540 disposed in the fixation catheter lumen 518 and may be moved through and along the fixation catheter lumen 518 and into the target location through the third opening 63 and into the third implantation channel 73.
[0143] In at least one embodiment, the method 400 may include providing the electrically conductive nanomaterial 428, or repeating providing the electrically conductive nanomaterial disposed in the fixation catheter lumen. Providing the electrically conductive nanomaterial 428 may include slidably disposing the electrically conductive nanomaterial on the guide element. A diagrammatic example of slidably disposing a third electrically conductive nanomaterial gel pellet 553 on the guide element 540 of the illustrative system 500 is shown in FIG. 7G. The third electrically conductive nanomaterial gel pellet 553 may be moved through the fixation catheter lumen 518 along a path defined by the guide element 540. The third electrically conductive nanomaterial gel pellet 553 may be moved through and along the fixation catheter lumen 518 toward the third implantation site 83.
[0144] In one or more embodiments, the method 400 may include implanting the electrically conductive nanomaterial 430, or repeating implanting the electrically conductive nanomaterial 430, such as implanting the third electrically conductivenanomaterial gel pellet 553. Implanting the electrically conductive nanomaterial 430 may include pushing the electrically conductive nanomaterial along a path defined by the guide element through the opening in the target location and into the implantation channel. A diagrammatic example of pushing the third electrically conductive nanomaterial gel pellet 553 of the illustrative system 500 into the third implantation channel 73 along the path defined by the guide element 540 is shown in FIG. 7H. The third electrically conductive nanomaterial gel pellet 553 may be moved, or pushed, by the pushing element 530 through the third opening 63 and into the third implantation channel 73 along the path defined by the guide element 540.
[0145] The method 400 may include withdrawing a guidewire 432, or repeating withdrawing a guidewire 432, such as withdrawing the guide element to complete implantation of the electrically conductive nanomaterial in the implantation channel. A diagrammatic example of withdrawing the guide element 540 of the illustrative system 500 from the third implantation channel 73 is shown in FIG. 71.
[0146] In some embodiments, forming the implantation channel 422 may include forming a curvature in the implantation channel. Diagrammatic examples of various stages or processes according to aspects of the method 400 and using an illustrative system 800 is shown in FIGS. 8A-8F, including forming the curvature in the implantation channel. A diagrammatic example of affixing a distal fixation catheter end region 814 of a fixation catheter 810 is shown in FIG. 8A. The fixation catheter 810 may include a fixation element 816 coupled to and extending from the distal fixation catheter end region 814. A penetration element 820 may be disposed in and movable in a fixation catheter lumen 818 of the fixation catheter 810. The penetration element 820 may be configured to define a penetration element curvature 826 when moved through the fixation catheter lumen 818 and beyond an opening in the distal fixation catheter end region 814. For example, the penetration element 820 may be a steerable guidewire, or stylet.
[0147] In some embodiments, and as shown in FIG. 8B, the penetration element 820 may be pre-formed to define the penetration element curvature 826 when moved through the fixation catheter lumen 818 and beyond the opening in the distal fixation catheter end region 814. For example, the penetration element 820 may be generally straight, while acurved penetration element region (not labelled) may be capable of holding a preformed shape (e.g., forming, or defining, the penetration element curvature 826) in the absence of external forces and further capable of flexing in response to sufficient lateral forces. More specifically, the curved penetration element region may conform to the shape of the fixation catheter lumen 818 while advancing therethrough, and revert to the preformed shape defining the penetration element curvature 826 when advanced beyond the opening in the distal fixation catheter end region 814.
[0148] In other words, while the distal penetration end region 824 advances through and along the fixation catheter lumen 818, the fixation catheter 810 applies sufficient lateral forces to conform the distal penetration end region 824 generally to the shape defined by the fixation catheter lumen 818. While the distal penetration end region 824 further advances through and beyond the opening in the distal fixation catheter end region 814 toward and into the interventricular septal wall 50, the tissue of the interventricular septal wall 50 does not apply sufficient lateral forces on the distal penetration end region 824, and so the distal penetration end region 824 reverts to the preformed shape defining the penetration element curvature 826.
[0149] In one or more embodiments, forming the implantation channel 422 in the target location using the penetration element may include forming an implantation channel defining a curvature. A diagrammatic example of forming a curved implantation channel 77, or an implantation channel that is at least partially curved, using the penetration element 820 of the illustrative system 800 is shown in FIG. 8B. Forming the implantation channel 422 may include moving the penetration element 820 through and along the fixation catheter lumen 818 to the target location, shown as the interventricular septal wall 50 in FIG. 8B. Forming the implantation channel 422 may include moving the penetration element into the target location to form an opening 60 into the target location and moving the distal penetration end region 824 from the opening 60 and into the target location to form the curved implantation channel 77 in the target location. Moving the distal penetration end region 824 from the opening 60 into the target location may include curving the distal penetration end region 824 to form the curvature in the curved implantation channel 77.
[0150] Moving the distal penetration end region 824 may include advancing the distal penetration end region 824 into, or further into, the target location and along the implantation axis 58 to form or define a portion of the curved implantation channel 77 that extends from a curved portion of the curved implantation channel 77 along the implantation axis 58. In other words, the method 400 may include moving the distal penetration end region 824 through the target location and along a portion of the cardiac conduction system, such as along an impairment in the cardiac conduction system, to form the portion of the curved implantation channel 77 extending from the curved portion of the curved implantation channel 77 and along the portion of the cardiac conduction system.
[0151] In one or more embodiments, the method 400 may include providing electrically conductive nanomaterial 428, such as one or more electrically conductive nanomaterial gel pellets, disposed in and movable in the fixation catheter lumen. A diagrammatic example of providing one or more electrically conductive nanomaterial gel pellets 850 (including a first electrically conductive nanomaterial gel pellet 851, a second electrically conductive nanomaterial gel pellet 852, a third electrically conductive nanomaterial gel pellet 853, and a fourth electrically conductive nanomaterial gel pellet 854), disposed in and movable in the fixation catheter lumen 818 of the illustrative system 800 is shown in FIG. 8C. The one or more electrically conductive nanomaterial gel pellets 850 may be movable in the fixation catheter lumen 818 using a pushing element 830. The one or more electrically conductive nanomaterial gel pellets 850 may be slidably disposed on the penetration element 820 to be movable along a path defined by the penetration element 820. Additionally, a guide pellet 846 may be disposed in and movable in the fixation catheter lumen 818. The guide pellet 846 may be slidably disposed on the penetration element 820 to be movable along the path defined by the penetration element 820.
[0152] In at least one embodiment, the method 400 may include implanting the electrically conductive nanomaterial 430, which may include implanting the electrically conductive nanomaterial into the curved implantation channel. A diagrammatic example of implanting the one or more electrically conductive nanomaterial gel pellets 850 of the illustrative system 800 into the curved implantation channel 77 is shown in FIG. 8D.Implanting the one or more electrically conductive nanomaterial gel pellets 850 may include moving the pushing element 830 through the fixation catheter lumen 818 to push the one or more electrically conductive nanomaterial gel pellets 850 into the target location through the opening 60 and into the curved implantation channel 77. Implanting the one or more electrically conductive nanomaterial gel pellets 850 may include moving the distal pushing end region 834 at least partially into the target location through the opening 60, which may include moving the distal pushing end region 834 at least partially into the curved implantation channel 70. In other words, the distal pushing end region 834 may move into the target location to push the one or more electrically conductive nanomaterial gel pellets 850 an implantation depth from the opening 60 into the curved implantation channel 77.
[0153] In some embodiments including slidably disposing the one or more electrically conductive nanomaterial gel pellets 850 on the penetration element 820, and as shown in FIG. 8D, the one or more electrically conductive nanomaterial gel pellets 850 may move into the curved implantation channel 77 along the path defined by the penetration element 820. Additionally or alternatively, the one or more electrically conductive nanomaterial gel pellets 850 may move into the curved implantation channel 77 along a path defined by the curved implantation channel 77.
[0154] In one or more embodiments, the method 400 may include withdrawing the guidewire 432, which may include withdrawing the penetration element. Withdrawing the guidewire 432 may optionally occur after implanting the electrically conductive nanomaterial 430 and before withdrawing the pushing element. A diagrammatic example of withdrawing the penetration element 820 of the illustrative system 800 from the curved implantation channel 77 after implanting the one or more electrically conductive nanomaterial gel pellets 850 and before withdrawing the pushing element 830 is shown in FIG. 8E. Withdrawing the penetration element before withdrawing the pushing element may be useful, for example, in that the pushing element 830 may keep the one or more electrically conductive nanomaterial gel pellets 850 within the curved implantation channel 77 while withdrawing the penetration element 820. In other words, the pushing element 830 may block, or at least partially block, the opening 60 in the target location toprevent the one or more electrically conductive nanomaterial gel pellets 850 from being withdrawn from the curved implantation channel 77 through the opening 60, for example due to friction or adhesion interaction between the electrically conductive nanomaterial gel pellets and the penetration element 820 while the penetration element 820 is withdrawing.
[0155] In some embodiments, the method 400 may include withdrawing the pushing element from the curved implantation channel, which may be described as completing implantation of the electrically conductive nanomaterial. A diagrammatic example of withdrawing the pushing element 830 of the illustrative system 800 from the curved implantation channel 77 is shown in FIG. 8F.
[0156] Further diagrammatic examples of various stages of the method 400 including forming the curvature in the implantation channel using the illustrative system 800 are shown in FIGS. 9A-9F. A diagrammatic example of affixing the distal fixation catheter end region 814 of the fixation catheter 810 is shown in FIG. 9A. A diagrammatic example of forming the curved implantation channel 77 using the penetration element 820 is shown in FIG. 9B.
[0157] In some embodiments, the method 400 may include withdrawing the penetration element 424 from the target location, which may occur before implanting the electrically conductive nanomaterial. A diagrammatic example of withdrawing the penetration element 820 of the illustrative system 800 from the curved implantation channel 77 before implanting the one or more electrically conductive nanomaterial gel pellets 850 is shown in FIG. 9C. The distal penetration end region 824 may be withdrawn from the curved implantation channel 77 and through the opening 60 in the target location. Withdrawing the distal penetration end region 824 from the target location may be described as leaving the curved implantation channel 77 ready for implanting the one or more electrically conductive nanomaterial gel pellets 850. The penetration element 820 may be further withdrawn, which may include withdrawing the penetration element 820 from the distal fixation catheter end region 814, as shown in FIG. 9D.
[0158] In one or more embodiments, the method 400 may include providing electrically conductive nanomaterial 428 disposed in and movable in the fixation catheter lumen. Adiagrammatic example of providing the one or more electrically conductive nanomaterial gel pellets 850 of the illustrative system 800 disposed in and movable in the fixation catheter lumen 818 is shown in FIG. 9E.
[0159] In at least one embodiment, the method 400 may include implanting the electrically conductive nanomaterial 430 into the implantation channel, which may include at least a portion defining an implantation curvature. A diagrammatic example of implanting the one or more electrically conductive nanomaterial gel pellets 850 of the illustrative system 800 into the curved implantation channel 77 is shown in FIG. 9F. The one or more electrically conductive nanomaterial gel pellets 850 may move into the curved implantation channel 77 along the path defined by the curved implantation channel 77.
[0160] In some embodiments, forming the implantation channel 422 (e.g., the curved implantation channel 77) in the interventricular septal wall 50 may include deflecting the penetration element along the left ventricular endocardium 54 of the interventricular septal wall 50, which may include deflecting the penetration element along the left ventricular endocardium 54 proximate the LBB 30 toward or away from the bundle of His 28. Diagrammatic examples of various stages or processes of the method 400 including forming the curved implantation channel 77 by deflecting the penetration element 820 of the illustrative system 800 along the left ventricular endocardium 54 of the interventricular septal wall 50 are shown in FIGS. 10A-10F. A diagrammatic example of affixing 416 the distal fixation catheter end region 814 is shown in FIG. 10A. A diagrammatic example of defining or forming the opening 60 in the right ventricular endocardium 52 using the penetration element 820 is shown in FIG. 10B.
[0161] In at least one embodiment, the method 400 may include forming the implantation channel 422, such as forming, or creating, the implantation channel deflecting along the left ventricular endocardium 54, which may include forming the implantation channel defining a curvature. A diagrammatic example of forming a curved implantation channel 77 deflecting along the left ventricular endocardium 54 using the penetration element 820 of the illustrative system 800 is shown in FIGS. 10C and 10D. A portion of the distal penetration end region 824 may define a penetration axis 828 when advancing, ormoving, through the fixation catheter lumen 818 and beyond an opening in the distal fixation catheter end region 814. An orientation of the penetration axis 828 may be non- orthogonal, or generally perpendicular (including, for example, parallel or generally parallel) relative to a plane defined by the left ventricular endocardium 54 while forming the implantation curvature in the implantation channel.
[0162] In some embodiments of the method 400 that include forming the implantation channel deflecting along the left ventricular endocardium 54, the penetration axis 828 may be orthogonal, or generally perpendicular, relative to the plane defined by the left ventricular endocardium 54 while the distal penetration end region 824 is moved through, or penetrates, the right ventricular endocardium 52, as shown in FIG. 10B. Forming the implantation channel using the penetration element 820 may include changing the orientation of the penetration axis 828 so that the penetration axis 828 is non-orthogonal, or generally non-perpendicular, to the plane defined by the left ventricular endocardium 54. For example, a portion of the distal penetration end region 824 may define a penetration curvature, such as a preformed curvature, between the opening 60 and the left ventricular endocardium 54, which may result in changing the orientation of the penetration axis 828, as shown in FIG 10C.
[0163] Without wishing to be bound by theory, the tissue characteristics of the left ventricular endocardium 54, which may be described as denser, or tougher, than the myocardial tissue between the left ventricular endocardium 54 and the right ventricular endocardium 52, may cause the penetration element 820 to deflect along the left ventricular endocardium (that is, the interface between the left ventricular endocardium and the myocardial tissue within the interventricular septal wall), rather than penetrating, or puncturing, the left ventricular endocardium. Still without wishing to be bound by theory, deflection may occur, or may be more likely to occur, when an orientation of the distal penetration end region 824 relative to the left ventricular endocardium 54 is non- orthogonal during contact between the distal penetration end region 824 and the left ventricular endocardium 54. The penetration element 820 may be formed, or made, of material suitable such that the penetration element 820 deflects along the left ventricular endocardium 54 during contact between the distal penetration end region 824 and the leftventricular endocardium 54. More specifically, the distal penetration end region 824 may be formed, or made, of material suitable to deflect along the left ventricular endocardium 54 during contact between the distal penetration end region 824 and the left ventricular endocardium 54.
[0164] In one or more embodiments wherein forming the implantation channel includes deflecting the penetration element 820 along the left ventricular endocardium 54, forming the implantation channel may include moving the penetration element along the left ventricular endocardium 54 of the interventricular septal wall 50 proximate the LBB 30 toward or away from the bundle of His 28. A diagrammatic example of moving the penetration element 820 of the illustrative system 800 along the left ventricular endocardium 54 of the interventricular septal wall 50 proximate the LBB 30 toward the bundle of His 28 is shown in FIG. 10D. Additionally or alternatively, moving the penetration element 820 along the left ventricular endocardium 54 may include moving the penetration element 820 along or proximate the implantation axis 58 toward or away from the bundle of His 28.
[0165] In some embodiments, the method 400 may include providing electrically conductive nanomaterial 428 disposed in and movable in the fixation catheter lumen. A diagrammatic example of providing the one or more electrically conductive nanomaterial gel pellets 850 of the illustrative system 800 disposed in and movable in the fixation catheter lumen 818 is shown in FIG. 10E. The one or more electrically conductive nanomaterial gel pellets 850 may be slidably disposed on the penetration element 820 to be movable along the path defined by the penetration element 820.
[0166] In one or more embodiments, the method 400 may include implanting the electrically conductive nanomaterial 430 into the curved implantation channel that deflects along the left ventricular endocardium 54. A diagrammatic example of implanting the one or more electrically conductive nanomaterial gel pellets 850 of the illustrative system 800 into the curved implantation channel 77 that deflects along the left ventricular endocardium 54 is shown in FIG. 10F. The one or more electrically conductive nanomaterial gel pellets 850 may move into the curved implantation channel77 along the path defined by the curved implantation channel 77 that deflects along the left ventricular endocardium 54.
[0167] In at least one embodiment, the method 400 may optionally include adjusting an orientation of the fixation catheter 418 relative to the target location while the distal fixation catheter end region is affixed to the target location. Diagrammatic examples of various stages, or processes, according to aspects of the method 400, including adjusting an orientation of a fixation catheter 1110 of an illustrative system 1100 are shown in FIGS. 11A-1 ID. A diagrammatic example of affixing, using a fixation element 1116, a distal fixation catheter end region 1114 of the fixation catheter 1110 disposed in a delivery catheter lumen 1168 of a delivery catheter 1160 and providing one or more electrically conductive nanomaterial gel pellets 1150 (including a first electrically conductive nanomaterial gel pellet 1151, a second electrically conductive nanomaterial gel pellet 1152, and a third electrically conductive nanomaterial gel pellet 1153), disposed in and movable in a fixation catheter lumen 1118 is shown in FIG. 11 A. The one or more electrically conductive nanomaterial gel pellets 1150 may be slidably disposed on a penetration element 1120 and moveable on a path defined by the penetration element 1120. Providing the one or more electrically conductive nanomaterial gel pellets 1150 may include moving the one or more electrically conductive nanomaterial gel pellets 1150 through and along the fixation catheter lumen 1118 to the target location using a pushing element 1130.
[0168] In some embodiments, the method 400 may include adjusting an orientation of the fixation catheter 418 relative to the target location while the distal fixation catheter end region is affixed to the target location. A diagrammatic example of adjusting an orientation of the fixation catheter 1110 of the illustrative system 1100 relative to the interventricular septal wall 50 while the distal fixation catheter end region 1114 is affixed, or coupled, to the interventricular septal wall 50 is shown in FIG. 1 IB. A portion of the distal penetration end region 1124 may define a penetration axis 1128. Adjusting an orientation of the fixation catheter 418 may include changing the orientation of the penetration axis 1128 so that the penetration axis 1128 is non-orthogonal, or generally non-perpendicular, to the plane defined by the target location.
[0169] Adjusting the orientation of the fixation catheter 418 may include advancing, or moving, the fixation catheter 1110 along the target location while the distal fixation catheter end region 1114 is affixed to the target location. In other words, the fixation catheter 1110 may generally move relative to the target location while the portion of the distal fixation catheter end region 1114 that is affixed to the target location (that is, the portion of the distal fixation catheter end region 1114 at which the fixation element 1116 is disposed, or coupled) may be fixed relative to the portion of the target location that is coupled to the distal fixation catheter end region. The portion of the distal fixation catheter end region 1114 that is affixed to the target location may define, or form, a pivot point about which the distal fixation catheter end region 1114 may generally pivot. More specifically, the distal fixation catheter end region 1114 may be advanced along the interventricular septal wall 50, for example, along an axis toward the bundle of His 28 to thereby adjust an orientation of the penetration axis 1128 so that the penetration axis 1128 points away from the bundle of His 28. As another example, the distal fixation catheter end region 1114 may be advanced along the interventricular septal wall 52 along an axis away from the bundle of His 28 to thereby adjust the orientation of the penetration axis 1128 so that the penetration axis 1128 points toward the bundle of His 28. Additionally or alternatively, and as shown in FIG. 11B, adjusting the orientation of the fixation catheter 418 may include advancing, or moving, the delivery catheter 1160 along the target location while the distal fixation catheter end region 1114 is affixed to the target location.
[0170] Changing the orientation of the penetration axis 1128 so that the penetration axis 1128 is non-orthogonal, or generally non-perpendicular, to the plane defined by the target location may be useful, for example, to improve deflection of the penetration element 1120 along the left ventricular endocardium 54 while forming the implantation channel that deflects along the left ventricular endocardium 54. As another example, changing the orientation of the penetration axis 1128 so that the penetration axis 1128 is non- orthogonal to the plane defined by the target location may be useful in combination with a steerable or pre-formed penetration element to form the curved implantation channel 77 along or proximate the implantation axis 58.
[0171] In at least one embodiment, the method 400 may include forming an implantation channel 422, which may include forming an implantation channel defining an implantation curvature. A diagrammatic example of forming a curved implantation channel 77 using the penetration element 1120 of the illustrative system 1100 is shown in FIG. 11C. Forming the curved implantation channel 77 may optionally occur after adjusting the orientation of the fixation catheter 418 or may optionally coincide, or at least partially coincide, with adjusting the orientation of the fixation catheter 418. Forming the curved implantation channel 77 after or coincident with adjusting the orientation of the fixation catheter 418 may be useful, for example, to adjust an orientation, or direction, of the penetration element 1120 (i.e., an orientation of the penetration axis 1128) while forming the curved implantation channel 77. As another example, forming the curved implantation channel 77 after or coincident with adjusting the orientation of the fixation catheter 418 may be useful to adjust the direction of, or the shape of, the implantation channel (e.g., the implantation channel 70 or the curved implantation channel 77) extending from the opening 60 into the target location.
[0172] In some embodiments, the method may include implanting the electrically conductive nanomaterial 430, which may include implanting the electrically conductive nanomaterial into the curved implantation channel. A diagrammatic example of implanting the one or more electrically conductive nanomaterial gel pellets 1150 of the illustrative system 1100 into the curved implantation channel 77 is shown in FIG. 1 ID. Implanting the one or more electrically conductive nanomaterial gel pellets 1150 may include moving the pushing element 1130 through the fixation catheter lumen 1118 to push the one or more electrically conductive nanomaterial gel pellets 1150 into the target location through the opening 60 and into the curved implantation channel 77.
[0173] In some embodiments including providing the electrically conductive nanomaterial slidably disposed on the guidewire 426, the method 400 may include slidably disposing the one or more electrically conductive nanomaterial gel pellets 1150 on the penetration element 1120, and as shown in FIG. 1 ID, the one or more electrically conductive nanomaterial gel pellets 1150 may move into the curved implantation channel 77 along the path defined by the penetration element 1120. Additionally or alternatively,the one or more electrically conductive nanomaterial gel pellets 1 150 may move into the curved implantation channel 77 along a path defined by the curved implantation channel 77. In some embodiments, the one or more electrically conductive nanomaterial gel pellets 1150 may move into the curved implantation channel 77 along a path defined by a curved penetration element deflecting along the left ventricular endocardium 54, or along a path defined by the curved implantation channel 77 deflecting along the left ventricular endocardium 54, or both.
[0174] Further diagrammatic examples of various stages or processes according to aspects of the method 400, including adjusting the orientation of the fixation catheter 1110 of the illustrative system 1100 are shown in FIGS. 12A-12F. A diagrammatic example of affixing the distal fixation catheter end region 1114 of the fixation catheter 1110 to the target location using the fixation element 1116 is shown in FIG. 12A. A diagrammatic example of adjusting an orientation of the fixation catheter 1110 relative to the target location while the distal fixation catheter end region 1114 is affixed to the target location is shown in FIG. 12B. A diagrammatic example of forming a curved implantation channel 77 using the penetration element 1120 of the illustrative system 1100 is shown in FIG. 12C.
[0175] In some embodiments, the method 400 may include withdrawing the penetration element 424 from the target location, which may occur before implanting the electrically conductive nanomaterial 430. A diagrammatic example of withdrawing the penetration element 1120 of the illustrative system 1100 from the curved implantation channel 77 before implanting the one or more electrically conductive nanomaterial gel pellets 1150 is shown in FIG. 12D.
[0176] In one or more embodiments, the method 400 may include providing electrically conductive nanomaterial 428 disposed in and movable in the fixation catheter lumen. A diagrammatic example of providing the one or more electrically conductive nanomaterial gel pellets 1150 disposed in and movable in the fixation catheter lumen 1118 of the illustrative system 1100 is shown in FIG. 12E.
[0177] In some embodiments, the method 400 may include implanting the electrically conductive nanomaterial 430 into the implantation channel, which may include a portiondefining an implantation curvature. A diagrammatic example of implanting the one or more electrically conductive nanomaterial gel pellets 1150 of the illustrative system 1100 into the curved implantation channel 77 is shown in FIG. 12F. The one or more electrically conductive nanomaterial gel pellets 1150 may move into the curved implantation channel 77 along the path defined by the curved implantation channel 77.ILLUSTRATIVE ASPECTS
[0178] The following is a list of illustrative aspects according to the present disclosure.
[0179] Aspect 1 is a system comprising: a fixation catheter extending from a proximal fixation catheter end region to a distal fixation catheter end region, the fixation catheter defining a fixation catheter lumen extending from the proximal fixation catheter end region to the distal fixation catheter end region, the distal fixation catheter end region positionable adjacent a target location, the fixation catheter comprising a fixation element coupled to and extending from the distal fixation catheter end region to affix the distal fixation catheter end region to the target location; a penetration element disposable in and movable in the fixation catheter lumen to form an opening into the target location and to form an implantation channel extending from the opening into the target location; and a pushing element extending from a proximal pushing end region to a distal pushing end region, the distal pushing end region disposable in and movable in the fixation catheter lumen to move an electrically conductive nanomaterial gel pellet through the fixation catheter lumen and into the target location through the opening and into the implantation channel.
[0180] Aspect 2 is the system of aspect 1, wherein the target location comprises an interventricular septal wall of a patient’s heart.
[0181] Aspect 3 is the system of any one of aspects 1-2, wherein the distal fixation catheter end region is positionable adjacent an interventricular septal wall of a patient’s heart.
[0182] Aspect 4 is the system of any one of aspects 1-3, wherein the fixation element is coupled to and extending from the distal fixation catheter end region to affix the distal fixation catheter end region to an interventricular septal wall of a patient’s heart.
[0183] Aspect 5 is the system of any one of aspects 1-4, wherein the penetration element is disposable and movable in the fixation catheter lumen to form the opening through a right ventricular endocardium of an interventricular septal wall of a patient’s heart, and to form the implantation channel extending from the opening into the interventricular septal wall.
[0184] Aspect 6 is the system of any one of aspects 1-5, wherein the distal pushing end region is disposable in and movable in the fixation catheter lumen to move the electrically conductive nanomaterial gel pellet through the fixation catheter lumen and into an interventricular septal wall of a patient’s heart, through the opening and into the implantation channel.
[0185] Aspect 7 is the system of any one of aspects 1-6, wherein the fixation catheter is disposable in and movable in a delivery catheter.
[0186] Aspect 8 is the system of any one of aspects 1-7, wherein the fixation catheter is steerable.
[0187] Aspect 9 is the system of any one of aspects 1-8, wherein the fixation element extends from the distal fixation catheter end region along a fixation axis, wherein the distal fixation catheter end region of the fixation catheter defines a fixation curvature to position the fixation axis of the fixation element orthogonal to a plane defined by the target location.
[0188] Aspect 10 is the system of any one of aspects 1-9, wherein the fixation element comprises a helix, a double-helix, or a combination thereof.
[0189] Aspect 11 is the system of any one of aspects 1-10, wherein the fixation element comprises an electrically conductive portion to map the target location.
[0190] Aspect 12 is the system of any one of aspects 1-11, wherein the fixation catheter further comprises an electrode to map the target location, the electrode coupled to the distal fixation catheter end region, or the fixation element, or both.
[0191] Aspect 13 is the system of any one of aspects 1 -12, wherein the penetration element extends from a proximal penetration end region to a distal penetration end region, wherein the distal penetration end region defines a penetration curvature to form an implantation curvature in the implantation channel when the distal penetration end region extends beyond the opening in the target location.
[0192] Aspect 14 is the system of any one of aspects 1-13, wherein the penetration element is steerable.
[0193] Aspect 15 is the system of any one of aspects 1-14, wherein the penetration element comprises one or more of a penetration pellet, a guidewire, a steerable guidewire, a pre-formed guidewire, a stylet, or a combination of two or more thereof.
[0194] Aspect 16 is the system of any one of aspects 1-15, wherein the pushing element defines a pushing element lumen, or a pushing element channel, or both, and wherein the penetration element is disposable in and movable in the pushing element lumen, or the pushing element channel, or both.
[0195] Aspect 17 is the system of any one of aspects 1-16, further comprising a guide element extending from a proximal guide end region to a distal guide end region, the guide element disposable in and movable in the fixation catheter lumen to move into the target location through the opening, wherein the electrically conductive nanomaterial gel pellet is slidably disposable along the guide element to move along a path defined by the guide element.
[0196] Aspect 18 is the system of any one of aspects 1-17, wherein the electrically conductive nanomaterial gel pellet is slidably disposable along the penetration element to move along a path defined by the penetration element.
[0197] Aspect 19 is the system of any one of aspects 1-18, further comprising a guide pellet detectable by a medical imaging system, the guide pellet implantable through the opening.
[0198] Aspect 20 is the system of any one of aspects 1-19, further comprising a depth measurement element disposable at the proximal pushing end region of the pushing element to measure longitudinal movement of the pushing element within the fixation catheter lumen.
[0199] Aspect 21 is the system of any one of aspects 1 -20, further comprising a depth measurement element comprising: an outer tubular element defining a lumen, the outer tubular element fixedly disposable at the proximal pushing end region of the pushing element; and an inner tubular element fixedly disposable at the proximal fixation catheter end region of the fixation catheter, the inner tubular element slidably disposable in the lumen of the outer tubular element.
[0200] Aspect 22 is a method comprising: delivering a fixation catheter to a target location, the target location defining an implantation site, the fixation catheter extending from a proximal fixation catheter end region to a distal fixation catheter end region, the fixation catheter defining a fixation catheter lumen extending from the proximal fixation catheter end region to the distal fixation catheter end region, and the fixation catheter comprising a fixation element coupled to and extending from the distal fixation catheter end region; affixing the distal fixation catheter end region to the target location proximate the implantation site using the fixation element; providing a penetration element disposed in the fixation catheter lumen; moving the penetration element through the fixation catheter lumen to the target location to penetrate and form an opening into the target location and to form an implantation channel extending from the opening into the target location; providing an electrically conductive nanomaterial gel pellet disposed in the fixation catheter lumen; providing a pushing element disposed in the fixation catheter lumen, the pushing element extending from a proximal pushing end region to a distal pushing end region; and moving the pushing element through the fixation catheter lumen to push the electrically conductive nanomaterial gel pellet into the target location through the opening and into the implantation channel.
[0201] Aspect 23 is the method of aspect 22, wherein the target location comprises an interventricular septal wall of a patient’s heart.
[0202] Aspect 24 is the method of any one of aspects 22-23, wherein delivering the fixation catheter to the target location comprises delivering the fixation catheter to an interventricular septal wall of a patient’s heart.
[0203] Aspect 25 is the method of any one of aspects 22-24, wherein affixing the distal fixation catheter end region to the target location comprises affixing the distal fixation catheter end region to an interventricular septal wall of a patient’s heart.
[0204] Aspect 26 is the method of any one of aspects 22-25, wherein moving the penetration element through the fixation catheter lumen to the target location to penetrate and form the opening into the target location and to form the implantation channel extending from the opening into the target location comprises moving the penetration element through the fixation catheter lumen to an interventricular septal wall of a patient’s heart to penetrate and form the opening through a right ventricular endocardium of the interventricular septal wall and to form the implantation channel extending from the opening into the interventricular septal wall.
[0205] Aspect 27 is the method of any one of aspects 22-26, wherein moving the pushing element through the fixation catheter lumen to push the electrically conductive nanomaterial gel pellet into the target location through the opening and into the implantation channel comprises moving the pushing element through the fixation catheter lumen to push the electrically conductive nanomaterial gel pellet into an interventricular septal wall of a patient’s heart through the opening and into the implantation channel.
[0206] Aspect 28 is the method of any one of aspects 22-27, further comprising: unaffixing the distal fixation catheter end region from the target location; moving the distal fixation catheter end region along the target location and positioning the distal fixation catheter end region proximate an auxiliary implantation site defined by the target location; affixing the distal fixation catheter end region to the target location proximate the auxiliary implantation site using the fixation element; forming an auxiliary opening into the target location using the penetration element; forming an auxiliary implantation channel extending from the auxiliary opening into the target location using the penetration element;providing an auxiliary electrically conductive nanomaterial gel pellet disposed in the fixation catheter lumen; and moving the pushing element through the fixation catheter lumen to push the auxiliary electrically conductive nanomaterial gel pellet into the target location through the auxiliary opening and into the auxiliary implantation channel.
[0207] Aspect 29 is the method of any one of aspects 22-28, wherein the target location comprises an interventricular septal wall of a patient’s heart and wherein forming the implantation channel comprises deflecting the penetration element along a left ventricular endocardium of the interventricular septal wall proximate a left bundle branch toward or away from a bundle of His.
[0208] Aspect 30 is the method of any one of aspects 22-29, wherein delivering the fixation catheter to the target location comprises: providing a delivery catheter; and moving the fixation catheter disposed in the delivery catheter through and along a lumen defined by the delivery catheter.
[0209] Aspect 31 is the method of any one of aspects 22-30, further comprising mapping the target location.
[0210] Aspect 32 is the method of any one of aspects 22-31, further comprising adjusting an orientation of the fixation catheter relative to the target location while the distal fixation catheter end region is affixed to the target location.
[0211] Aspect 33 is the method of any one of aspects 22-32, wherein forming the implantation channel comprises forming a curvature in the implantation channel.
[0212] Aspect 34 is the method of any one of aspects 22-33, wherein at least a portion of the implantation channel is non-orthogonal to a plane defined by the target location.
[0213] Aspect 35 is the method of any one of aspects 22-34, further comprising at least partially withdrawing the penetration element from the implantation channel before moving the pushing element through the fixation catheter lumen to push the electrically conductive nanomaterial gel pellet into the target location through the opening and into the implantation channel.
[0214] Aspect 36 is the method of any one of aspects 22-35, wherein providing the electrically conductive nanomaterial gel pellet disposed in the fixation catheter lumen comprises providing the electrically conductive nanomaterial gel pellet slidably disposed on the penetration element and movable along a path defined by the penetration element.
[0215] Aspect 37 is the method of any one of aspects 22-36, further comprising moving a guide element disposed in the fixation catheter lumen through the fixation catheter lumen and into the target location through the opening and into the implantation channel, wherein providing the electrically conductive nanomaterial gel pellet disposed in the fixation catheter lumen comprises slidably disposing the electrically conductive nanomaterial gel pellet on the guide element, and wherein moving the pushing element through the fixation catheter lumen to push the electrically conductive nanomaterial gel pellet into the target location through the opening and into the implantation channel comprises pushing the electrically conductive nanomaterial gel pellet along a path defined by the guide element.
[0216] Aspect 38 is the method of any one of aspects 22-37, wherein moving the pushing element through the fixation catheter lumen to push the electrically conductive nanomaterial gel pellet into the target location through the opening and into the implantation channel comprises moving the electrically conductive nanomaterial gel pellet along a path defined by the penetration element.
[0217] Aspect 39 is the method of any one of aspects 22-38, wherein moving the pushing element through the fixation catheter lumen to push the electrically conductive nanomaterial gel pellet into the target location through the opening and into the implantation channel comprises moving the pushing element through the fixation catheter lumen to push a plurality of electrically conductive nanomaterial gel pellets through the fixation catheter lumen and into the target location through the opening and into the implantation channel.
[0218] Aspect 40 is a system comprising: a fixation catheter extending from a proximal fixation catheter end region to a distal fixation catheter end region, the fixation catheter defining a fixation catheter lumen extending from the proximal fixation catheter end region to the distal fixation catheterend region, the distal fixation catheter end region positionable adjacent a right ventricular endocardium of an interventricular septal wall of a patient's heart, the fixation catheter comprising a fixation element coupled to and extending from the distal fixation catheter end region to affix the distal fixation catheter end region to right ventricular endocardium; a penetration element disposable in and movable in the fixation catheter lumen to form an opening through the right ventricular endocardium and to form an implantation channel extending from the opening into the interventricular septal wall; and a pushing element extending from a proximal pushing end region to a distal pushing end region, the distal pushing end region disposable in and movable in the fixation catheter lumen to move an electrically conductive nanomaterial gel pellet through the fixation catheter lumen and into the interventricular septal wall through the opening and into the implantation channel.
Claims
CLAIMSWhat is claimed:
1. A system comprising: a fixation catheter extending from a proximal fixation catheter end region to a distal fixation catheter end region, the fixation catheter defining a fixation catheter lumen extending from the proximal fixation catheter end region to the distal fixation catheter end region, the distal fixation catheter end region positionable adjacent a target location, the fixation catheter comprising a fixation element coupled to and extending from the distal fixation catheter end region to affix the distal fixation catheter end region to the target location; a penetration element disposable in and movable in the fixation catheter lumen to form an opening into the target location and to form an implantation channel extending from the opening into the target location; and a pushing element extending from a proximal pushing end region to a distal pushing end region, the distal pushing end region disposable in and movable in the fixation catheter lumen to move an electrically conductive nanomaterial gel pellet through the fixation catheter lumen and into the target location through the opening and into the implantation channel.
2. A method comprising: delivering a fixation catheter to a target location, the target location defining an implantation site, the fixation catheter extending from a proximal fixation catheter end region to a distal fixation catheter end region, the fixation catheter defining a fixation catheter lumen extending from the proximal fixation catheter end region to the distal fixation catheter end region, and the fixation catheter comprising a fixation element coupled to and extending from the distal fixation catheter end region; affixing the distal fixation catheter end region to the target location proximate the implantation site using the fixation element; providing a penetration element disposed in the fixation catheter lumen;moving the penetration element through the fixation catheter lumen to the target location to penetrate and form an opening into the target location and to form an implantation channel extending from the opening into the target location; providing an electrically conductive nanomaterial gel pellet disposed in the fixation catheter lumen; providing a pushing element disposed in the fixation catheter lumen, the pushing element extending from a proximal pushing end region to a distal pushing end region; and moving the pushing element through the fixation catheter lumen to push the electrically conductive nanomaterial gel pellet into the target location through the opening and into the implantation channel.
3. The system or the method as in any one of claims 1 and 2, wherein the target location comprises an interventricular septal wall of a patient’s heart, and optionally wherein the distal fixation catheter end region is positionable adjacent the interventricular septal wall of a patient’s heart.
4. The system or the method as in any one of claims 1 - 3, wherein the fixation element is coupled to and extending from the distal fixation catheter end region to affix the distal fixation catheter end region to an interventricular septal wall of a patient’s heart.
5. The system or the method as in any one of claims 1 - 4, wherein the penetration element is disposable and movable in the fixation catheter lumen to form the opening through a right ventricular endocardium of an interventricular septal wall of a patient’s heart, and to form the implantation channel extending from the opening into the interventricular septal wall.
6. The system or the method as in any one of claims 1 - 5, wherein the distal pushing end region is disposable in and movable in the fixation catheter lumen to move the electrically conductive nanomaterial gel pellet through the fixation catheter lumen and into an interventricular septal wall of a patient’s heart, through the opening and into the implantation channel.
7. The system or the method as in any one of claims 1 - 6, wherein one or more of the fixation catheter and the penetration element is steerable.
8. The system or the method as in any one of claims 1 - 7, wherein the fixation element extends from the distal fixation catheter end region along a fixation axis, wherein the distal fixation catheter end region of the fixation catheter defines a fixation curvature to position the fixation axis of the fixation element orthogonal to a plane defined by the target location.
9. The system or the method as in any one of claims 1 - 8, wherein the penetration element extends from a proximal penetration end region to a distal penetration end region, wherein the distal penetration end region defines a penetration curvature to form an implantation curvature in the implantation channel when the distal penetration end region extends beyond the opening in the target location.
10. The system or the method as in any one of claims 1 - 9, wherein the electrically conductive nanomaterial gel pellet is slidably disposable along the penetration element to move along a path defined by the penetration element.
11. The system or the method as in any one of claims 1 - 10, further comprising a guide pellet detectable by a medical imaging system, the guide pellet implantable through the opening.
12. The method as in any one of claims 2 - 11, further comprising: unaffixing the distal fixation catheter end region from the target location; moving the distal fixation catheter end region along the target location and positioning the distal fixation catheter end region proximate an auxiliary implantation site defined by the target location; affixing the distal fixation catheter end region to the target location proximate the auxiliary implantation site using the fixation element; forming an auxiliary opening into the target location using the penetration element; forming an auxiliary implantation channel extending from the auxiliary opening into the target location using the penetration element;providing an auxiliary electrically conductive nanomaterial gel pellet disposed in the fixation catheter lumen; and moving the pushing element through the fixation catheter lumen to push the auxiliary electrically conductive nanomaterial gel pellet into the target location through the auxiliary opening and into the auxiliary implantation channel.
13. The method as in any one of claims 2 - 12, wherein moving the pushing element through the fixation catheter lumen to push the electrically conductive nanomaterial gel pellet into the target location through the opening and into the implantation channel comprises moving the pushing element through the fixation catheter lumen to push the electrically conductive nanomaterial gel pellet into an interventricular septal wall of a patient’s heart through the opening and into the implantation channel.
14. The method as in any one of claims 2 - 13, wherein at least a portion of the implantation channel is non-orthogonal to a plane defined by the target location and optionally wherein forming the implantation channel comprises forming a curvature in the implantation channel.
15. The method as in any one of claims 2 - 14, wherein moving the pushing element through the fixation catheter lumen to push the electrically conductive nanomaterial gel pellet into the target location through the opening and into the implantation channel comprises moving the pushing element through the fixation catheter lumen to push a plurality of electrically conductive nanomaterial gel pellets through the fixation catheter lumen and into the target location through the opening and into the implantation channel.
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