Includes lead construction for aligning marker elements.

Abstract

An implantable device includes two or more alignment marker elements, and a system and method for manufacturing such an implantable device, as well as a method for utilizing such an implantable device. For example, an implantable device may include a first alignment marker element and a second alignment marker element, which can be used to ensure proper alignment with a target site.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 139,661 entitled "Lead Construction Including Alignable Marker Elements", filed January 20, 2021, and U.S. Provisional Patent Application No. 63 / 139,662 entitled "Lead Construction", filed January 20, 2021, the entire contents of each of which are incorporated herein by reference.

[0002] This disclosure relates generally to medical devices, and more specifically to additive manufacturing or 3D printing of medical devices, such as catheters and implantable stimulation leads, including alignable marker elements.

[0003] Medical catheters and leads are commonly used to access blood vessels and other locations within the body and perform various functions at these locations. For example, delivery catheters can be used to deliver medical devices such as implantable medical leads. Many such medical devices are designed to navigate tortuous paths within the body, such as through a patient's vascular system. Medical catheters and leads can be designed to be flexible enough to move through bends or turns in the vascular system, yet rigid or resilient enough to be pushed through it. In many cases, such as those involving the cardiovascular system, the path to the treatment or deployment site may be tortuous, and there may be conflicting design considerations that require trade-offs between size, flexibility, material selection, and operational control. These contrasting properties present challenges in the design and manufacture of catheters. Existing manufacturing processes, such as conventional extrusion, may also limit the options available for designing and manufacturing catheters.

[0004] When deploying treatments to specific locations within anatomical structures, the alignment of the features of the catheter or delivery system within the body can be critical. Three-dimensional spatial orientation during the navigation, delivery, and / or implantation of implantable devices (e.g., leads, catheters, or other implantable devices) can be challenging for observation imaging. For example, it is known that some implanters may perceive the implantable device they are implanting (e.g., a lead) as being near the septum of the heart, when in reality the implantable device is near the free wall of the heart.

[0005] Cardiac resynchronization therapy (CRT) is an effective treatment for patients with heart failure. CRT procedures involve simultaneous or asynchronous pacing of the right ventricle (RV) and left ventricle (LV). Implantation of the LV pacing lead is one of the determining factors for CRT response. To achieve effective resynchronization, the final placement of the LV pacing lead can be achieved by targeting the most recently activated area of ​​the left ventricle within the coronary sinus. However, LV lead placement can present several challenging technical issues and depends on the highly variable anatomy of the coronary vessels. Unfortunately, some patients are not candidates for CRT because their venous anatomy is too small or difficult to access with the lead (e.g., the lead may not be able to navigate within the venous anatomy). Summary of the Invention

[0006] The technology disclosed herein relates generally to additive manufacturing of medical devices, such as catheters and leads, which allows for further customization of medical devices by providing a more convenient way to include components within the medical device. For example, the systems and techniques described herein can provide the ability to design and print an initial layer having internal spaces for components, followed by printing a finishing layer on top of the initial layer and the component. These systems and techniques can allow for the manufacture of more complex medical devices without increasing manufacturing complexity. Specifically, in one embodiment, the catheter may include an internal groove within which multiple lumen traction wires can be disposed. In another embodiment, the catheter may define an empty space for fluid travel during balloon inflation and may include, for example, raised surfaces to help support an outer sheath.

[0007] This disclosure further describes various multi-lumen and embedded components in catheters, guides, or implantable stimulation leads manufactured in three-dimensional (3D) printing or additive manufacturing, providing features that are activated at the distal / proximal end of the device when in vivo. One or more of these distal / proximal components can aid in navigation, sensing, visualization, electrical stimulation, fixation, or guide a second tool to a location. 3D printing with these features allows for greater complexity than conventional manufacturing methods and can be easily combined with complex sheathing molding that is not achievable with current manufacturing methods.

[0008] Exemplary structures that can be manufactured or produced using this disclosure may include lumens for inflatable, articulated, sensing, electric, or assistive tool components. Other processes for producing catheters with multiple lumens typically involve reflowing extruded polymer onto a component on a mandrel, which can result in the catheter taking the shape of the internal components with little control over the placement of the internal components or the final sheath shape. When 3D printing is performed, as described herein, the shape of the sheath can be designed independently of the internal components and can be designed to focus on mechanical properties and anatomical interactions without impeding the function of the internal components. Furthermore, those internal features as described in this disclosure can be combined with external features.

[0009] Furthermore, it can be described that when using the methods and systems described herein, devices such as catheters or leads can be printed with embedded components without extrusion or reflow. Because component placement can be precisely achieved and the 3D printing or additive manufacturing system can be described as modular, tools, codes, etc., can be freely changed to add or remove features. Therefore, the preparation of samples for patient or in vivo testing can be greatly simplified. Moreover, it can be described that internal components can be embedded into the 3D printing device without affecting the shape of the outer sheath. Additionally, 3D printing can be described as "opening up" new cross-sections and three-dimensional geometries that might not be achievable with existing manufacturing methods. Furthermore, these new shapes can be designed to complement a variety of internal embedded components.

[0010] One or more embodiments that can be formed or manufactured using the exemplary methods and systems described herein include double-lumen unbraided tubing, double-lumen braided tubing, deflectable conduit with embedded traction wires, and lumens embedded in raised geometries, all formed without an extruder.

[0011] An exemplary implantable device may include: a body defining a distal region extending along a distal region axis; and two or more alignment marker elements coupled to the body within the distal region. Each of the two or more alignment marker elements may define a complementary shape that is complementary to one or more of the other alignment marker elements, such that when the distal region is viewed axially, the two or more alignment marker elements form a reference shape that indicates acceptable alignment of the distal region for positioning at a target site.

[0012] An exemplary additive manufacturing system may include one or more heated barrels. Each heated barrel extends from a proximal side to a distal side and includes a substrate inlet port located on the proximal side and a substrate outlet port located on the distal side, and each heated barrel defines an internal volume and a substrate channel extending from the proximal side through the internal volume to the distal side. Furthermore, each heated barrel defines a first filament port in fluid communication with the internal volume to receive a first filament. The system may also include a heating element and a filament handling system, the heating element being thermally coupled to each of the one or more heated barrels to heat the internal volume, the filament handling system including one or more motors to feed at least a first filament through the first filament port into the internal volume. The system may also include a substrate handling system including a headstock and one or more motors, the headstock including a distal clamp to secure a distal portion of an elongated substrate, wherein the substrate is positioned through the substrate channel when secured by the headstock, the one or more motors being used to translate or rotate one or both of the substrate secured by the headstock and the heated barrels relative to each other. The system may also include an intermediate component system and a controller positioned near the heating barrel for positioning two or more alignable marker elements. The controller is operatively coupled to the heating element, one or more motors of the filament processing system, and one or more motors of the substrate processing system. The controller may be configured to: control one or more motors of the filament processing system to selectively control the feeding of a first filament into an internal volume; activate the heating element to melt any portion of the first filament in the internal volume; control one or more motors of the substrate processing system to move the substrate and one or both of the heating barrels relative to each other in at least the longitudinal direction to form a first elongated guide sheath surrounding the substrate; and control the intermediate component system to deposit two or more alignable marker elements onto the first elongated guide sheath within a distal region element such that, when the distal region is viewed axially, the two or more alignable marker elements form a reference shape indicating an acceptable alignment of the distal region for positioning at a target site.

[0013] An exemplary method for navigating an implantable device in a patient's heart may include providing an implantable device comprising: a body defining a distal region extending along a distal region axis; and two or more alignment marker elements coupled to the body within the distal region, wherein each of the two or more alignment marker elements defines a complementary shape, the complementary shape being complementary to the other alignment marker elements, such that the two or more alignment marker elements form a reference shape when the distal region is viewed axially. The method may further include: navigating the distal region near a target site; generating an image of the target site perpendicular to the two or more alignment marker elements; and determining that the two or more alignment marker elements form a reference shape in the generated image indicating acceptable alignment of the distal region.

[0014] An exemplary method of forming a lead may include: providing a lead body extending from a proximal region to a distal region, the lead body defining a lumen in which a conductor is positioned; defining an opening through the lead body; extending the conductor through the lumen to the exterior of the lead body; and positioning a C-shaped electrode near the conductor outside the lead body. The method may further include electrically connecting the C-shaped electrode to the conductor and mechanically connecting the C-shaped electrode to the lead body.

[0015] An exemplary lead may include a lead body extending from a proximal end to a distal end and defining an S-shaped region near the distal end, a first vertex region within the S-shaped region, and a second vertex region within the S-shaped region. The lead may further include a first electrode positioned at the first vertex region and a second electrode positioned at the second vertex region.

[0016] Details of one or more aspects of this disclosure are set forth in the following drawings and description. Other features, objectives, and advantages of the technology described in this disclosure will be apparent from the specification, drawings, and claims. Attached Figure Description

[0017] Figure 1 This is a conceptual diagram of an exemplary additive manufacturing system based on this disclosure.

[0018] Figure 2 Is with, for example Figure 1 A conceptual diagram of an exemplary additive manufacturing equipment used in conjunction with an additive manufacturing system.

[0019] Figure 3 Is with, for example Figure 1 A conceptual diagram of an exemplary heated barrel used in additive manufacturing systems.

[0020] Figure 4 It is possible to, for example Figure 1 A conceptual diagram of an exemplary exit die used in a heated barrel in an additive manufacturing system.

[0021] Figure 5 It can be used for example Figure 1 A conceptual diagram of another example of an exit die in a heated barrel of an additive manufacturing system.

[0022] Figure 6 It is usable Figure 1 A conceptual diagram of an exemplary catheter sheath with a first sheath and cutouts, manufactured using an additive manufacturing system.

[0023] Figure 7 This is a conceptual diagram of another exemplary additive manufacturing system based on this disclosure.

[0024] Figure 8 The additive manufacturing system described herein is used to include the traction wire and the second sheath. Figure 6 A conceptual diagram of an exemplary catheter sheath.

[0025] Figure 9 yes Figure 8 A conceptual diagram of the cross-section of an exemplary catheter.

[0026] Figure 10 The diagram illustrates, for example... Figure 1 A flowchart of an example of a method used in conjunction with an additive manufacturing system.

[0027] Figure 11 It is possible to use relative to Figures 1 to 6 A side view of an exemplary quadrupole lead manufactured by the system and method described.

[0028] Figure 12 yes Figure 11 An example diagram of the developed electrodes of a quadrupole lead.

[0029] Figures 13A to 13E It shows that Figure 12 The electrodes are connected to Figure 11 A cross-sectional view illustrating an exemplary method for quadrupole leads.

[0030] Figures 14A to 14E It shows that Figure 12 The electrodes are connected to Figure 11 Photographic side view of an exemplary method for quadrupole leads.

[0031] Figure 15 yes Figures 12 to 1 Perspective view of electrode 4.

[0032] Figure 16 It is possible to use relative to Figures 1 to 6And a side view of an exemplary quadrupole lead fabricated by the system and method described in Figures 13 and 14.

[0033] Figure 17 It is possible to use relative to Figures 1 to 6 And a side view of another exemplary quadrupole lead fabricated by the system and method described in Figures 13 and 14.

[0034] Figure 18 It is an illustrative view of the leads of two alignment marker elements implanted within the diaphragm wall of the right ventricle.

[0035] Figure 19A yes Figure 18 An illustrative view of the lead wires.

[0036] Figure 19B It is an illustrative view including another lead of two alignable marker elements.

[0037] Figures 20A to 20B These are simulated right anterior oblique (RAO) fluorescence images taken at a 20-degree angle perpendicular to the septum, depicting leads including two alignable marker elements, where the leads are not in the intended alignment for implantation into the septum and where the leads are in the intended alignment for implantation into the septum.

[0038] Figure 21A A side view of an exemplary lead that is acceptablely aligned is depicted, the lead including two alignable marker elements positioned near a target site.

[0039] Figure 21B Depicting images taken perpendicular to the target area. Figure 21A An illustrative image of the lead wire.

[0040] Figure 22A Depicting less desirable alignments located near the target site. Figure 21A A side view of an illustrative lead.

[0041] Figure 22B Depicting perpendicular to Figure 21A An illustrative image of the target area, in which the lead wires are shown. Figure 22A That kind of positioning and orientation.

[0042] Figure 23A This is a simulated RAO fluorescence perspective image taken at a 20-degree offset from the septum, depicting two alignable marker elements. Figure 21A The lead wire, wherein the lead wire is in a position similar to Figures 21A to 21B The expected alignment is shown in the diagram.

[0043] Figure 23BThis is a simulated RAO fluorescence perspective image taken at a 20-degree offset from the septum, depicting two alignable marker elements. Figure 21A The lead wire, wherein the lead wire is not in a similar position to Figures 22A to 22B The expected alignment is shown in the diagram.

[0044] Figure 24A A side view of an exemplary lead to be aligned is depicted, the lead including two alignment marker elements positioned near the target site.

[0045] Figure 24B Depicting images taken perpendicular to the target area. Figure 24A An illustrative image of the lead wire.

[0046] Figure 25A Depicting less desirable alignments located near the target site. Figure 24A A side view of an illustrative lead.

[0047] Figure 25B Depicting perpendicular to Figure 24A An illustrative image of the target area, in which the lead wires are shown. Figure 25A That kind of positioning and orientation.

[0048] Figure 26A This is a simulated RAO fluorescence perspective image taken at a 20-degree offset from the septum, depicting two alignable marker elements. Figure 24A The lead wire, wherein the lead wire is in a position similar to Figures 24A to 24B The expected alignment is shown in the diagram.

[0049] Figure 26B This is a simulated RAO fluorescence perspective image taken at a 20-degree offset from the septum, depicting two alignable marker elements. Figure 24A The lead wire, wherein the lead wire is not in a similar position to Figures 25A to 25B The expected alignment is shown in the diagram.

[0050] Figure 27 It is shown that it is used for Figure 11 as well as Figures 16 to 17 A cross-sectional view of an exemplary electrode configuration for a quadrupole lead.

[0051] Figure 28A A side view of an illustrative alignment lead is depicted, which includes two alignable marker elements positioned near a target site.

[0052] Figure 28B and Figure 28C Depicting Figure 28A A cross-sectional view of the lead wire.

[0053] Figure 28D Depicting perpendicular to Figure 28A An illustrative image of the target area, in which the lead wires are shown. Figure 28A Positioned and oriented as shown.

[0054] Figure 28E and Figure 28F Depicting perpendicular to Figure 28A An illustrative image of the target area, in which the lead wires are positioned and oriented as expected.

[0055] Figure 29A A side view of an exemplary alignment lead is depicted, which includes two alignment marker elements positioned near a target site.

[0056] Figure 29B and Figure 29C yes Figure 29A A cross-sectional view of the lead wire.

[0057] Figure 29D Depicting perpendicular to Figure 29A An illustrative image of the target area, in which the lead wires are shown. Figure 29A Positioned and oriented as shown.

[0058] Figure 29E and Figure 29F Depicting perpendicular to Figure 29A An illustrative image of the target area, in which the lead wires are positioned and oriented as expected.

[0059] Figure 30A A side view of an exemplary alignment lead is depicted, which includes two alignment markers positioned near a target site.

[0060] Figure 30B This is a simulated left anterior oblique (LAO) fluorescence fluoroscopic image taken at a 20-degree angle perpendicular to the septum, depicting an image including two alignable marker elements. Figure 30A The lead wire.

[0061] Figure 31 It is a perspective view of an exemplary embodiment of two alignable marker elements connected by two extension elements.

[0062] Figure 32A A side view of an exemplary alignment lead is depicted, which includes two alignment marker elements positioned near a target site.

[0063] Figure 32B and Figure 32C Depicting Figure 32A A cross-sectional view of the lead wire.

[0064] Figure 32D Depicting perpendicular to Figure 32AAn illustrative image of the target area, in which the lead wires are shown. Figure 32A Positioned and oriented as shown.

[0065] Figure 33A A side view of an exemplary alignment lead is depicted, which includes two alignment marker elements positioned near a target site.

[0066] Figure 33B and Figure 33C It describes Figure 33A A cross-sectional view of the lead wire.

[0067] Figure 33D Depicting perpendicular to Figure 33A An illustrative image of the target area, indicating the orientation of the lead wire toward the target area.

[0068] Figure 33E Depicting perpendicular to Figure 33A An illustrative image of the target region, indicating that the lead wire is oriented away from the target region.

[0069] Figure 34A A side view of an exemplary alignment lead is depicted, which includes multiple alignment marker elements located in a coil positioned near a target site.

[0070] Figure 34B Depicting parallel to Figure 34A An illustrative image of the target area, indicating the orientation of the lead wire toward the target area.

[0071] Figure 34C Depicting perpendicular to Figure 34A An illustrative image of the target area, indicating the orientation of the lead wire toward the target area.

[0072] Figure 34D Depicting parallel to Figure 34A An illustrative image taken of the target area, indicating that the lead wire is not oriented toward the target area.

[0073] Figure 34E Depicting perpendicular to Figure 34A An illustrative image taken of the target area, indicating that the lead wire is not oriented toward the target area.

[0074] Figure 34F Depicting parallel to Figure 34A An illustrative image taken of the target area, indicating that the lead wire is not oriented toward the target area.

[0075] Figure 34G Depicting perpendicular to Figure 34A An illustrative image taken of the target area, indicating that the lead wire is not oriented toward the target area.

[0076] Figure 35A A side view depicts an exemplary lead in an unintended and less desirable alignment positioned near the target site.

[0077] Figure 35B Depicting perpendicular to Figure 35A Exemplary images of the target area, showing, for example... Figure 35A Leads that are positioned and oriented in that way.

[0078] Figure 36A A side view of an exemplary alignment lead is depicted, the lead including a directional indicator alignment marker element positioned near a target site.

[0079] Figure 36B Depicting perpendicular to Figure 36A An illustrative image of the target area, in which the lead wires are shown. Figure 36A Positioned and oriented as shown.

[0080] Figure 36C and 36D Depicting perpendicular to Figure 36A An illustrative image of the target area, in which the lead wires are positioned and oriented as expected.

[0081] Figure 37 It is a perspective view including illustrative leads of multiple alignable marker elements.

[0082] Figure 38A and Figure 38B A side view of an illustrative alignment lead is depicted, which includes multiple alignable marker elements positioned near a target site.

[0083] Figure 38C Depicting perpendicular to Figure 38A An illustrative image of the target area, in which the lead wires are shown. Figure 39A Positioned and oriented as shown.

[0084] Figure 38D Depicting perpendicular to Figure 38A An illustrative image of the target area, in which the lead wires are positioned and oriented as expected.

[0085] Figure 39A A side view of an exemplary alignment lead is depicted, which includes multiple alignment marker elements positioned near a target site.

[0086] Figure 39B Depicting perpendicular to Figure 39A An illustrative image of the target area, in which the lead wires are shown. Figure 39A Positioned and oriented as shown.

[0087] Figure 39C Depicting perpendicular to Figure 39A An illustrative image of the target area, in which the lead wires are positioned and oriented as expected. Detailed Implementation

[0088] This disclosure provides additive manufacturing systems and methods for medical devices, such as catheters and leads, which allow for the provision of more than one sheath or layer to form the medical device. For example, one or more layers (e.g., an initial sheath or layer) may define a shape or structure in which internal components can be positioned, and subsequent layers or sheaths may cover or embed the internal components. The included internal shapes and components may be determined by the desired functional characteristics or properties of the medical device. Specifically, components or empty spaces may be included on top of an initial print of filament material (e.g., a first layer or sheath), and subsequent layers or sheaths of filament material may be printed thereon. As described herein, printing may be performed in multiple stages or as part of simultaneous printing using multiple printheads and tools. Additionally, this disclosure includes methods for coupling electrodes to leads, various lead shapes and orientations, and leads including alignable marker elements, each of which can be facilitated using the additive manufacturing systems and methods described herein.

[0089] As used herein, the term "or" is an inclusive definition, such as meaning "and / or", unless the context clearly specifies otherwise. The term "and / or" means one or all of the listed elements or a combination of at least two of the listed elements.

[0090] As used herein, the phrases “at least one of” and “one or more of” following the list of elements refer to one or more of any of the listed elements or any combination of one or more of the listed elements.

[0091] As used herein, the terms “connection” or “link” refer to at least two elements being directly or indirectly attached to each other. An indirect connection may include one or more other elements between the at least two attached elements. Both terms may be modified by the interchangeable terms “operationally” and “operably” to describe a connection or link configured to allow components to interact to perform the stated or otherwise known function. For example, a controller may be operably connected to a resistance heating element to allow the controller to supply current to the heating element.

[0092] As used herein, any terms relating to position or orientation, such as “proximal,” “distal,” “end,” “outer,” “inner,” etc., refer to relative position and do not limit the absolute orientation of the implementation, unless the context otherwise clearly specifies.

[0093] Unless otherwise stated, all scientific and technical terms used herein have the meanings commonly used in the art. The definitions provided herein are intended to facilitate understanding of certain terms frequently used herein and are not intended to limit the scope of this disclosure.

[0094] Reference will now be made to the accompanying drawings, which depict one or more aspects described in this disclosure. However, it should be understood that other aspects not depicted in the drawings fall within the scope of this disclosure. The same numbers used in the drawings refer to the same parts, steps, etc. However, it should be understood that the use of reference characters to designate elements in a given drawing is not intended to limit elements in another drawing labeled with the same reference characters. Furthermore, the use of different reference characters to designate elements in different drawings is not intended to indicate that elements referenced differently cannot be the same or similar.

[0095] Figure 1 An example of an additive manufacturing system 100 according to this disclosure is shown. System 100 can be configured and used to produce conduits, conduit components, leads, or subassemblies. System 100 can use or include consumable filament materials or resins in granular form having various hardness levels. System 100 can be configured to operate a wide variety of process conditions to produce conduits, conduit components, leads, or subassemblies using resins in filament or granular form with various hardness levels. Generally, system 100 defines a distal region 128 or distal end and a proximal region 130 or proximal end. System 100 may include a platform 124 comprising a rigid frame to support one or more components of the system.

[0096] Other components and methods of use of System 100 are described in the following patent applications: U.S. Patent Application 17 / 081,815, entitled "Additive Manufacturing for Medical Devices", filed October 27, 2020; U.S. Provisional Patent Application Serial 63 / 001,832, entitled "3D PRINTED SPLINES ON MEDICALDEVICES AND METHODS TO MANUFACTURE THE SAME", filed March 30, 2020; Patent Application Serial 63 / 059,867, entitled "Systems and Methods for Manufacturing 3D Printed Medical Devices", filed July 31, 2020; U.S. Provisional Patent Application Serial 63 / 059,890, entitled "Systems and Methods for Manufacturing 3D Printed Medical Devices", filed July 31, 2020; and U.S. Provisional Patent Application Serial 63 / 059,870, entitled "3D Printed Medical Devices Including..." Internal Shaping, filed July 31, 2020; and U.S. Provisional Patent Application Serial No. 63 / 130,321, entitled Medical Devices with Multi-plane Articulation, filed December 23, 2020, each of which is incorporated herein by reference in its entirety. For example, as illustrated in the illustrative embodiments, system 100 may include one or more components such as a heated barrel 102, a heating element 104, a filament handling system 106, an optional wire handling system 107, a substrate handling system 108, a controller 110, and a user interface 112. The filament handling system 106 may be operatively coupled to the heated barrel 102. The filament handling system 106 may supply one or more filaments 114 to the heated barrel 102. The optional wire handling system 107 may be used to supply one or more wires 115 to the heated barrel 102. The heating element 104 may be operatively or thermally coupled to the heated barrel 102. Heating element 104 can provide heat from one or more filaments 114 supplied by filament processing system 106 to melt the filament material in heating barrel 102. Optional wire 115 may not be melted by heating barrel 102. Substrate processing system 108 can be operatively coupled to heating barrel 102. Substrate processing system 108 can provide substrate 116 extending through heating barrel.Molten filament material located in the heated barrel 102 can be applied to the substrate 116. The substrate 116 or the heated barrel 102 can be translated or rotated relative to each other via the substrate processing system 108. The substrate processing system 108 can be used to move the substrate 116 or the heated barrel 102 relative to each other to cover the substrate 116 with molten filament material, thereby forming a sheath 118. Optional wire 115 can be incorporated into the sheath 118 (e.g., molded into the sheath, laminated within the sheath, etc.).

[0097] The substrate 116 may also be described as a mandrel or rod. A sheath 118 may be formed or deposited around the substrate 116. In some embodiments, the sheath 118 may be formed concentrically around the substrate 116. In one example, the sheath 118 is formed concentrically and centered around the substrate 116.

[0098] When system 100 is used to manufacture catheters or catheter components, sheath 118 may be described as a catheter sheath. Some or all of the substrate 116 may be removed or detached from sheath 118, and the remaining structure attached to the sheath may form a catheter or catheter component, such as a sheath. Figure 6 An example of a catheter that can be formed by system 100 is shown.

[0099] The substrate 116 may be formed of any suitable material capable of allowing molten filament material to be formed thereon. In some embodiments, the substrate 116 is formed of a material that melts at a higher temperature than any of the filaments 114. An example of a material that can be used to form the substrate 116 includes stainless steel.

[0100] Controller 110 may be operatively coupled to one or more of heating element 104, filament processing system 106, substrate processing system 108, and user interface 112. Controller 110 may activate, start, or otherwise “turn on” heating element 104 to provide heat to heating barrel 102 to melt the filament material therein. Furthermore, controller 110 may control or command one or more motors or actuators of various parts of system 100. Additionally, controller 110 may control one or more motors or actuators of filament processing system 106 to provide one or more filaments 114. Furthermore, controller 110 may control one or more motors or actuators of substrate processing system 108 to move one or both of heating barrel 102 or substrate 116 relative to each other. Furthermore, controller 110 may send or receive data to user interface 112, for example, to display information or receive user commands. Control of components operatively coupled to controller 110 may be determined based on user commands received by user interface 112. In some implementations, user commands may be provided in the form of machine-readable code or a coded language.

[0101] The substrate handling system 108 can be provided using any suitable specific implementation. In some embodiments, the substrate handling system 108 may include one or more head frames 120, optional tail frames 122, and one or more motors coupled to or included in the head frames or tail frames. One or both of the head frames 120 and tail frames 122 may be coupled to the platform 124. A frame can be defined as a structure that holds or secures the substrate 116 during the formation of the sheath 118. The head frame 120 is defined as the frame closest to the end of the substrate 116, where the formation of the sheath 118 begins during the formation process. In the illustrated embodiment, the sheath 118 is shown proximal to the head frame 120 and distal to the heated barrel 102.

[0102] When substrate 116 is secured by one or both of frames 120, 122, the substrate is typically positioned through a substrate channel defined by the heated cylinder 102. One or both of frames 120, 122 may include clamps or other securing mechanisms to selectively hold substrate 116. Such clamps may be operatively coupled to a substrate motor. In some embodiments, the substrate motor may be used to control the opening and closing of the clamps. In some embodiments, the substrate motor may be used to rotate substrate 116 about a longitudinal axis 126 in a clockwise or counterclockwise direction. A translation motor is operatively coupled between frames 120, 122 and platform 124. In some embodiments, the translation motor may be used to translate frames 120, 122 in a longitudinal direction along the longitudinal axis 126. In some embodiments, the translation motor may be further used to translate frames 120, 122 in a transverse direction other than the longitudinal axis 126. The transverse direction may be oriented substantially orthogonal to or perpendicular to the longitudinal axis 126.

[0103] In some embodiments, the substrate processing system 108 may be configured to move the headstock 120 relative to the platform 124 at least in the longitudinal direction (e.g., parallel to the longitudinal axis 126). This movement of the headstock 120 relative to the platform 124 allows the substrate 116 to be fed through the substrate channel of the heated barrel 102. The distal portion of the substrate 116 may be clamped in the headstock 120. At the start of the sheathing process, the headstock 120 may be positioned close to the heated barrel 102. The headstock 120 may move distally away from the heated barrel 102, for example, in a direction parallel to the longitudinal axis 126. In other words, the headstock 120 may move toward the distal region 128 of the system 100 while pulling the fixed substrate 116 through the heated barrel 102. As the substrate 116 passes through the heated barrel 102, molten filament material from the filament 114 may be formed or deposited on the substrate 116 to form the sheath 118. The heating cylinder 102 can be stationary relative to the platform 124. In some embodiments, the tailstock 122 can be omitted.

[0104] In some embodiments, the substrate processing system 108 may be configured to move the heating cylinder 102 relative to the platform 124 at least in the longitudinal direction (along the longitudinal axis 126). Substrate 116 may be fed through the substrate channel of the heating cylinder 102. The distal portion of the substrate 116 may be clamped in the headstock 120. The proximal portion of the substrate 116 may be clamped in the tailstock 122. In one example, at the start of the sheathing process, the heating cylinder 102 may be positioned close to the headstock 120. The heating cylinder 102 may move proximally away from the headstock 120. The heating cylinder 102 may move toward the proximal region 130 of the system 100. As the heating cylinder 102 passes the substrate 116, molten filament material may be deposited onto the substrate 116 to form a sheath. The headstock 120 and tailstock 122 may be stationary relative to the platform 124. In another example, the heating cylinder 102 may begin near the tailstock 122 and move toward the distal region 128.

[0105] One or more motors of the substrate processing system 108 may be used to rotate one or both of the substrate 116 and the heating cylinder 102 relative to each other. In some embodiments, only the substrate 116 may rotate about the longitudinal axis 126. In some embodiments, only the heating cylinder 102 may rotate about the longitudinal axis 126. In some embodiments, both the substrate 116 and the heating cylinder 102 may rotate about the longitudinal axis 126.

[0106] The heating cylinder 102 may be part of a subassembly 132. The subassembly 132 may be coupled to a platform 124. In some embodiments, one or more motors of the substrate processing system 108 may be coupled between the subassembly 132 and the platform 124 to translate or rotate the subassembly 132, including the heating cylinder 102, relative to the platform 124 or the substrate 116. In some embodiments, one or more motors of the substrate processing system 108 may be coupled between the frame of the subassembly 132 and the heating cylinder 102 to translate or rotate the heating cylinder relative to the platform 124.

[0107] In some embodiments, the substrate 116 may be rotated relative to the heated barrel 102 about a longitudinal axis 126 to facilitate the formation of certain structures of the sheath. In one example, one or both of the headstock 120 and tailstock 122 of the substrate processing system 108 may rotate the substrate 116. In another example, the substrate processing system 108 may rotate the heated barrel 102 or the subassembly 132.

[0108] System 100 may include one or more concentricity guides 134. The concentricity guides 134 facilitate adjusting the concentricity of the sheath around the substrate 116 before or after the substrate passes through the heating cylinder 102. The concentricity guides 134 may be longitudinally spaced from the heating cylinder 102. In some embodiments, the spacing may be greater than or equal to 1 cm, 2 cm, 3 cm, 4 cm, or 5 cm. The spacing may be sufficient to allow the sheath 118 to cool and no longer be deformable. In some embodiments, one or more concentricity guides 134 may be positioned distal to the heating cylinder 102 and engage the sheath 118. In some embodiments, one or more concentricity guides 134 may be positioned proximal to the heating cylinder 102 to engage the substrate 116. The concentricity guides 134 can reduce sagging of the substrate 116 and are less susceptible to eccentricity when aligning the frames 120, 122 and the heating cylinder 102.

[0109] The filament processing system 106 can be provided using any suitable specific implementation. One or more filaments 114 can be loaded into the filament processing system 106. For example, the filaments 114 can be provided in the form of wound coils. The filaments 114 can be fed to the heated barrel 102 through the filament processing system 106. In some embodiments, the filament processing system 106 may include one, two or more clamping rollers to engage one or more filaments 114. In some embodiments, the filament processing system 106 may include one or more motors. One or more motors may be coupled to one or more clamping rollers to control the rotation of these clamping rollers. The force applied by the motors to the clamping rollers and thus to one or more filaments 114 can be controlled by a controller 110.

[0110] In some embodiments, the filament processing system 106 may be configured to feed filaments 114 comprising at least a first filament and a second filament. A sheath 118 may be formed of one or both of the materials of the filaments 114. The filament processing system 106 is capable of selectively feeding the first and second filaments. For example, one motor may feed the first filament and another motor may feed the second filament. Each motor may be independently controlled by a controller 110. Selective or independent control of the feeding may allow the same or different feed forces to be applied to each filament of the filaments 114.

[0111] Filament 114 can be made from any suitable material, such as polyethylene, PEBAX elastomer (commercially available from Arkema SA (Colombes, France)), nylon 12, polyurethane, polyester, liquid silicone rubber (LSR) or PTFE.

[0112] The filament 114 may have any suitable Shore hardness. In some embodiments, the filament 114 may have or be defined with a Shore hardness suitable for the catheter. In some embodiments, the filament 114 has a Shore hardness of at least 25A and up to 90A. In some embodiments, the filament 114 has a Shore hardness of at least 25D and up to 80D.

[0113] In some embodiments, the filament processing system 106 may provide soft filaments as one of the filaments 114. In some embodiments, the soft filaments may have a Shore A hardness of less than or equal to 90A, 80A, 70A, 80D, 72D, 70D, 60D, 50D, 40D, or 35D.

[0114] In some embodiments, the filament processing system 106 can provide hard filaments and soft filaments with a Shore hardness lower than that of the soft filaments. In some embodiments, the soft filaments have a Shore hardness that is 10D, 20D, 30D, 35D, or 40D lower than that of the hard filaments.

[0115] System 100 can be configured to provide a sheath 118 with a Shore hardness between that of hard filaments and soft filaments. In some embodiments, the filament processing system 106 can provide hard filaments with a Shore hardness of 72D or higher and soft filaments with a Shore hardness of 35D or higher. System 100 is capable of providing a sheath 118 with a Shore hardness of 35D or higher and less than or equal to 72D.

[0116] System 100 can be configured to provide a sheath 118 having or defining a plurality of segments with different Shore hardness. In some embodiments, system 100 is capable of providing a sheath 118 having one or more of 35D, 40D, 55D and 72D segments.

[0117] The filament 114 may have any suitable width or diameter. In some embodiments, the filament 114 has a width or diameter of 1.75 mm. In some embodiments, the filament 114 has a width or diameter less than or equal to 1.75 mm, 1.5 mm, 1.25 mm, 1 mm, 0.75 mm, or 0.5 mm.

[0118] The segments may have uniform or non-uniform Shore hardness. System 100 may be configured to provide a sheath 118 having one or more segments with non-uniform Shore hardness. In some embodiments, the sheath 118 may include a continuous transition between at least two different Shore hardnesses, such as... Figure 6 As shown.

[0119] The controller 110 can be configured to vary the feed force applied to one or more filaments 114 to change the ratio of material in the sheath over the longitudinal distance. By varying the feed force, the system 100 can provide different Shore A hardness segments in the sheath 118, whether uniform or non-uniform. In one example, a sharp transition between uniform segments can be provided by stopping or slowing the longitudinal movement while continuously or discretely varying the feed force of one filament of the substrate 116 relative to another filament relative to the heated barrel 102 in large steps. In another example, a gradual transition between segments can be provided by continuously or discretely varying the feed force of one filament relative to another filament in small steps while moving the substrate 116 longitudinally relative to the heated barrel 102.

[0120] One or more wires 115 provided by the wire handling system 107 can be introduced in any suitable manner. In some embodiments, the wire 115 may be attached to a substrate 116 and pulled by movement of the substrate. An example of a wire is a traction wire that can be used to manipulate a conduit manufactured by system 100. In some embodiments, a specially shaped heated cylinder may be used to hold one or more wires 115.

[0121] Any suitable type of heating element 104 can be used. In some embodiments, the heating element 104 may be a resistance heating element that provides heat in response to an electric current. Other types of heating elements that can be used for the heating element 104 include radio frequency (RF) or ultrasonic heating elements. The heating element 104 is capable of providing enough heat to melt the filament 114. In some embodiments, the heating element 104 can heat the filament 114 to a temperature greater than or equal to 235°C, 240°C, 250°C, or 260°C. Generally, one or more heating elements 104 can be used to heat the filament 114 to any suitable melting temperature known to those skilled in the art who benefit from this disclosure.

[0122] Figure 2 An example of the additive manufacturing equipment 200 of the additive manufacturing system 100 is shown in an end view along the longitudinal axis 126, which is shown as a circle and a cross. More details of some components of the additive manufacturing system 100 are shown, such as the heated barrel 102 and the filament handling system 106.

[0123] The heating cylinder 102 may include a heating block 202 that at least partially defines an internal volume 204. The internal volume 204 may be heated by a heating element 104. The heating element 104 may be thermally coupled to the heating block 202 to melt the filament material within the internal volume 204. Generally, the system 100 may be configured to melt any portion of the filament 114 within the internal volume 204. The heating element 104 may be disposed within an exposed volume or an external volume defined in the heating block 202. The heating element 104 may be positioned near or adjacent to the internal volume 204. In some embodiments, one, two, three, or more heating elements 104 may be thermally coupled to the heating block 202.

[0124] The heating block 202 allows a substrate 116, which may be an elongated substrate or component, to pass through the heating block. The substrate 116 can extend or pass through the internal volume 204. A substrate channel 206 defined by the heating cylinder 102 can extend through the internal volume 204. The substrate channel 206 can extend in the same or similar direction as the substrate 116. The substrate channel 206 can extend along the longitudinal axis 126.

[0125] The width or diameter of the internal volume 204 is greater than the width or diameter of the substrate 116. The width or diameter of the internal volume 204 or the substrate 116 is defined in a transverse direction orthogonal to the longitudinal axis 126. In one example, the transverse direction may be defined along the transverse axis 210. In some embodiments, the gap between the substrate 116 and the internal volume 204 is relatively small to facilitate the formation of a sheath 118 around the substrate 116. Figure 1 The composition of the filament material was changed.

[0126] The portion of the internal volume 204 surrounding the substrate 116 can receive a flow of molten filament material from the filament 114. When more than one filament material is supplied to the internal volume 204, the filament materials can flow around the substrate 116 and be blended or mixed.

[0127] In the illustrated embodiment, filament 114 includes a first filament 212 and a second filament 214. The first filament 212 is provided into the internal volume 204 through a first filament port 216, which is at least partially defined by the heating block 202. The second filament 214 is provided into the internal volume 204 through a second filament port 218, which is at least partially defined by the heating block 202. Each filament port 216, 218 is in fluid communication with the internal volume 204.

[0128] The filament 114 may be delivered to the internal volume 204 in the same or different manner. In the illustrated embodiment, the first filament 212 is delivered to the internal volume 204 in a different manner than the second filament 214.

[0129] The filament processing system 106 may include a first processing subassembly 220. The first processing subassembly 220 delivers a first filament 212 into an internal volume 204. The first processing subassembly 220 may include one or more pressure rollers 222. Each of the one or more pressure rollers 222 may be operatively coupled to a motor. Any suitable number of pressure rollers 222 may be used. As shown, the first processing subassembly 220 may include two sets of pressure rollers 222. The pressure rollers 222 may be used to apply a prime mover to the first filament 212 to move the first filament, for example, toward the internal volume 204.

[0130] The heating cylinder 102 may include a first guide sheath 224. The first guide sheath 224 may extend between the filament processing system 106 and the internal volume 204. The first guide sheath 224 may be coupled to the heating block 202. The first guide sheath 224 may extend from the outside of the heating block 202 into the first filament port 216. The first guide sheath 224 may define a lumen in fluid communication with the internal volume 204. The internal width or diameter of the lumen may be defined to be greater than the width or diameter of the first filament 212. The first filament 212 may extend from the pressure roller 222 of the first processing subassembly 220 through the first guide sheath 224 to the first filament port 216 and extend distally through the first guide sheath 224 into the internal volume 204.

[0131] As used here with respect to filament 114, the term "far side" refers to the direction closer to the internal volume 204, while the term "proximal side" refers to the direction closer to the filament processing system 106.

[0132] In some embodiments, the proximal end of the first guide sheath 224 may terminate near one of the pressure rollers 222. The distal end of the first guide sheath 224 may terminate at a shoulder 226 defined by the first filament port 216. The distal portion or distal end of the first guide sheath 224 may be positioned close to or adjacent to the internal volume 204.

[0133] The internal width or diameter of the lumen of the first guide sheath 224 can be defined to be substantially the same as or equal to the internal width or diameter of the first filament port 216 (such as the minimum internal width or diameter of the first filament port). In other words, the inner surface of the first guide sheath 224 can be flush with the inner surface of the first filament port 216.

[0134] In some embodiments, the heating cylinder 102 may include a support element 228. The support element 228 may be coupled to a first guide sheath 224. The first guide sheath 224 may extend through a lumen defined by the support element 228. The support element 228 may be adjacent to the heating block 202. In an illustrated embodiment, the support element 228 is coupled to the heating block 202. The support element 228 may include a coupling protrusion configured to be mechanically coupled to a coupling receiver 230 defined by a first filament port 216. In some embodiments, the coupling receiver 230 may define threads, and the coupling protrusion of the support element 228 may define complementary threads.

[0135] The coupling receiver 230 may terminate at the shoulder 226 of the first filament port 216. The coupling protrusion of the support element 228 may be designed to terminate at the shoulder 226. In some embodiments, the distal end of the support element 228 and the distal end of the first guide sheath 224 may engage the shoulder 226. In other embodiments, the distal end of the support element 228 may engage the shoulder 226, and the distal end of the first guide sheath 224 may engage a second shoulder (not shown) defined by the first filament port 216 located distal to the shoulder 226.

[0136] When the first filament port 216 defines a shoulder, the first filament port 216 may define at least two different internal widths or diameters. The larger internal width or diameter may be set to pass through the support element 228, and the smaller internal width or diameter may be set to match the internal width or diameter of the first guide sheath 224.

[0137] When the second filament port 218 defines two shoulders, the first filament port 216 may define at least three different internal widths or diameters. The largest internal width or diameter may be sized to pass through the support element 228. The intermediate internal width or diameter may be sized to accommodate the distal portion of the first guide sheath 224. The smallest internal width or diameter may be sized to match the internal width or diameter of the first guide sheath 224.

[0138] The filament processing system 106 may include a second processing subassembly 232. The second processing subassembly 232 delivers the second filament 214 into the internal volume 204. The second processing subassembly 232 may include one or more pressure rollers 222. Each of the one or more pressure rollers 222 may be operatively coupled to a motor. Any suitable number of pressure rollers 222 may be used. As shown, the second processing subassembly 232 may include a set of pressure rollers 222. The pressure rollers 222 can be used to apply a driving force to the second filament 214.

[0139] The heating cylinder 102 may include one or more of a second guide sheath 234, a heat sink 236, and a heat interruption section 238. The second guide sheath 234 may extend at least between the second processing subassembly 232 and the heat sink 236. The second guide sheath 234 may be coupled to the heat sink. The second guide sheath 234 may be coupled to the second processing subassembly 232. The heat sink 236 may be coupled to the heat interruption section 238. The heat interruption section 238 may be coupled to the heating block 202. The heat interruption section 238 may extend from the outside of the heating block 202 into the second filament port 218.

[0140] The second guide sheath 234 may define a lumen in fluid communication with the internal volume 204. A second filament 214 may extend through the second guide sheath 234 from the second processing subassembly 232 to the heat sink 236, through the heat sink 236, through a thermal interruption, and then through the second filament port 218. In some embodiments, the second guide sheath 234 may extend to the pressure roller 222 in the second processing subassembly 232. In some embodiments, the second guide sheath 234 may extend at least partially into the heat sink 236.

[0141] A thermal interruption portion 238 may be located adjacent to the heating block 202. The thermal interruption portion 238 may be positioned between the heat sink 236 and the heating block 202. The thermal interruption portion 238 may include a coupling protrusion configured to mechanically engage with a coupling receiver 240 defined by a second filament port 218. In some embodiments, the coupling receiver 240 may define threads, and the coupling protrusion of the thermal interruption portion 238 may define complementary threads. The second filament port 218 may include one or more shoulders, such as those described with respect to the first filament port 216, except that the second filament port 218 may not be configured to receive the second guide sheath 234. The internal width or diameter of the support element 228 may be larger than the internal width or diameter of the thermal interruption portion 238, for example, to accommodate the external width or diameter of the first guide sheath 224. In other embodiments, the second filament port 218 may be configured to receive the second guide sheath 234 in a manner similar to that of the first filament port 216, which receives the first guide sheath 224.

[0142] The guide sheaths 224 and 234 can be made of any suitable material. In some embodiments, one or both of the guide sheaths 224 and 234 may comprise a synthetic fluoropolymer. One or both of the guide sheaths 224 and 234 may comprise polytetrafluoroethylene (PTFE). Another suitable material may comprise ultra-high molecular weight polyethylene (UHMWPE).

[0143] Any suitable material can be used to manufacture the support element 228. In some embodiments, the support element 228 may be a thermal insulator. The support element 228 may comprise a thermoplastic. The support element 228 may be made of polyamide-imide, such as TORLON polyamide-imide (commercially available from McMaster-Carr Supply Co. (Elmhurst, Illinois)). Other suitable materials may include liquid crystal polymers, polyaryletherketones (PAEK), polyphenylene sulfide, and polysulfone.

[0144] Support element 228 provides mechanical support for the first guide sheath 224. Support element 228 may comprise a substantially rigid material. In some embodiments, support element 228 comprises a material having a higher hardness than the material used to manufacture the first guide sheath 224.

[0145] Heat sink 236 can be made from any suitable material. Heat sink 236 may include a material with high thermal conductivity. In some embodiments, heat sink 236 includes aluminum.

[0146] The thermal interruption portion 238 can be made of any suitable material. The thermal interruption portion 238 may include a material with low thermal conductivity. In some embodiments, the thermal interruption portion 238 includes titanium. The thermal interruption portion 238 may include a necking portion to reduce the amount of material between the proximal and distal portions of the thermal interruption portion. The necking portion may help reduce the thermal conductivity between the proximal and distal portions of the thermal interruption portion 238.

[0147] Generally, the use of device 200 can be advantageous for using softer filaments at high feed forces and pressures, which tend to compress soft filaments and may cause blockage. Using higher feed forces and pressures allows for a wider range of process conditions and provides a consistent sheath around the substrate. Specifically, the use of a first guide sheath 224 that extends at least partially into the first filament port 216 can be advantageous for using softer filaments and greater "pushing power". Additionally or alternatively, the use of support element 228 can also be advantageous for using softer filaments and greater "pushing power". In other embodiments, device 200 may include a screw or static mixer to aid in pushing the softer filaments. In other words, the screw or static mixer can provide a cavity for moving the softer filament material forward between the threads of the screw.

[0148] Figure 3A partial cross-sectional side view of an example of a heating cylinder 102 is shown. The heating cylinder 102 or heating block 202 may extend from a proximal side 410 to a distal side 412. In some embodiments, the heating cylinder 102 may include one or more of the following: a heating block 202, an inlet die 402 coupled to the proximal side 410 of the heating block, an outlet die 404 coupled to the distal side 412 of the heating block, a proximal retaining plate 406 that facilitates holding the inlet die close to the heating block, and a distal retaining plate 408 that facilitates holding the outlet die close to the heating block.

[0149] The inlet die 402 and the outlet die 404 can be held in any suitable manner. In an illustrated embodiment, the outlet die 404 can be held by the distal shoulder of the distal retaining plate 408. In some embodiments, the inlet die 402 can be held by the proximal retaining plate 406 between the distal shoulder of the proximal retaining plate 406 and a fastener (such as a nut having a lumen extending through it), the fastener being threaded onto the retaining plate to engage the proximal surface of the inlet die. The retaining plates 406, 408 can be fastened to the heating block 202 in any suitable manner.

[0150] The inlet die 402 may at least partially define the substrate inlet port 414. The outlet die 404 may at least partially define the substrate outlet port 416. The inlet die 402 may at least partially define the internal volume 204. The outlet die 404 may at least partially define the internal volume 204. In some embodiments, the outer surface of the inlet die 402, the inner surface of the outlet die 404, and the inner surface of the heating block 202 may together define the internal volume 204.

[0151] The substrate channel 206 can be described as extending from the proximal side 410 to the distal side 412 of the heating cylinder 102, or vice versa. The substrate channel 206 may extend through the internal volume 204. As shown, the substrate channel 206 may extend through one or more of the proximal retaining plate 406, the inlet die 402, the heating block 202, the outlet die 404, and the distal retaining plate 408.

[0152] Figure 4 This shows a heating cylinder 102 ( Figure 1 An example end view of an inlet or outlet die head 700 in a substrate. The die head 700 may define a substrate inlet port or outlet port 702. Port 702 may define a main region 704 and one, two, three, four, or more cutouts 706 or cutout regions. In the illustrated embodiment, port 702 defines four cutouts 706.

[0153] When an internally cross-sectional die 700 is used in the exit die, the sheath formed by the heated barrel 102 may include a plurality of protrusions corresponding to the number of cuts 706 used in the die 700. For example, the die 700 shown will produce four protrusions on the sheath.

[0154] In some implementations, the size of one or more cuts in cut 706 can be set to receive wire 115 ( Figure 1 ), such as traction wires, the wires can be handled by the wire handling system 107 ( Figure 1 Provided. In some embodiments, the internal cross-sectional shape of the die 700 may be used in both the input die and the output die to accommodate the wire 115 being drawn through the cut 706.

[0155] Figure 5 This shows a heating cylinder 102 ( Figure 1 An end view of an example inlet or outlet die 720. The die 720 may define a substrate inlet or outlet port 722. Port 722 may define a main region 724 and one, two, three, four, or more protrusions 726 or cutout regions. In the illustrated embodiment, port 722 defines two protrusions 726 or teeth.

[0156] When an internally cross-sectional die 720 is used in the exit die, the sheath formed by the heated barrel 102 may include multiple channels corresponding to the number of protrusions 726 used in the die 720. For example, the die 720 shown will produce two channels in the sheath.

[0157] The shape and features of the exit die 720 can control the shape and features of the resulting first sheath 500. For example, as Figure 6 As shown, a cutout 504 is defined in the outer surface 502 of the first sheath 500. The first sheath 500 may be similar to the sheath 118 described herein, but may be an initial sheath formed and may include geometric features thereon (e.g., cutout 504), on which a second sheath may subsequently be formed. The cutout 504 may be a result of a corresponding exit die through which the first sheath 500 is formed. For example, Figure 6 The first sheath 500 defines four symmetrical cuts having a partially circular shape. Therefore, the exit die through which the first sheath 500 passes includes four symmetrical protrusions that are semi-circular and extend toward the center of the opening of the exit die. Furthermore, the cuts 504 may extend along and parallel to the longitudinal axis 126, or may spiral or fold around the outer surface 502 of the first sheath 500. Although Figure 6 Four symmetrical cutouts 504 are shown, but the feature portion confined within the first sheath 500 can be any suitable shape and / or size.

[0158] In forming including such Figure 6 Following the first sheath 500 of the feature portion shown, one or more internal components (e.g., lumens, traction wires, pads, marker elements, alignable marker elements, electrodes, electrode connectors, etc.) may be formed or deposited on the first sheath 500 (e.g., within the feature portion defined in the first sheath 500). For example, the internal components may be positioned within channels, between protrusions, or within protrusions formed in the first sheath. The traction wire 115 may be provided by the wire handling system 107 (e.g., as shown in the image). Figure 1 (As shown) and positioned within the cutout 504. Specifically, the number of traction lines may correspond to the number of internal components formed on the first sheath 500. For example... Figure 6 As shown, four traction wires may be positioned within the first sheath 500 (e.g., one traction wire in each cut 504). By positioning the traction wires within the pre-formed cuts 504, the traction wires can be spaced more effectively and uniformly.

[0159] Subsequently, a second sheath may be formed around the first sheath 500 and any internal components positioned therein. The second sheath may be formed similarly to the first sheath 500 (or, for example, as described herein, since it pertains to sheath 118), such as by feeding the second filament into the internal cavity of a heated barrel, melting the second filament within the internal cavity, and moving the heated barrel to form the second sheath. Alternatively, the same heated barrel as the first sheath or a different heated barrel may be used to form the second sheath.

[0160] For example, in one or more embodiments, the heating cylinder 102 of system 100 (e.g., as...) Figure 1 The substrate can be passed through multiple times (e.g., twice) to form each of the first and second sheaths. While the heating cylinder 102 extends the length of the substrate 116 to form the first sheath 500 of the desired length, the heating cylinder 102 can return to the starting position and begin forming the second sheath. In other words, the first filament can be fed into and melted within the internal cavity of the heating cylinder 102 to form the first sheath, and the second filament can be fed into and melted within the same internal cavity of the heating cylinder 102 to form the second sheath. In such embodiments, the first and second filaments can be the same filament fed into the heating cylinder 102 (e.g., where the heating cylinder 102 includes only a single filament port). Although in some embodiments, as described herein, the heating cylinder 102 may include at least two filament ports. Thus, the first sheath can be formed from the first filament, and the second sheath can be formed from a second filament different from the first filament. In one or more embodiments, the first and second sheaths can be formed from any combination of both the first and second filaments.

[0161] In addition, such as Figure 7As shown, system 101 may include an auxiliary heating cylinder 103 located distal to or behind the heating cylinder 102. Specifically, the auxiliary heating cylinder 103 may be longitudinally spaced from the heating cylinder 102 (e.g., along longitudinal axis 126). System 101 may include components that are coupled with… Figure 1 The system 100 described contains all the same components as the heating cylinder 102, but includes an additional heating cylinder 103. Furthermore, the additional heating cylinder 103 may include all the same features as the heating cylinder 102, but may be physically separable from the heating cylinder 102. In such embodiments, the heating cylinder 102 may form a first sheath, and the additional heating cylinder 103 may subsequently form a second sheath around the first sheath. For example, the heating cylinder 102 may define a first filament port in fluid communication with its internal volume to receive a first filament, and the additional heating cylinder 103 may define a second filament port in fluid communication with the internal volume of the additional heating cylinder to receive a second filament.

[0162] Even if the heating cylinder is a separate component, the first and second filaments may comprise the same or different filament materials. Furthermore, each of the heating cylinder 102 and the additional heating cylinder 103 may include two or more filament ports, allowing the sheath to be formed from a mixture of materials. As described herein, the properties of the sheath (e.g., flexibility) can be customized by combining filament materials into a single sheath. Depending on the properties of the material mixture of the first and second sheaths, one or more traction lines located within the conduit (e.g., between the first and second sheaths) can produce different types of conduit movement. For example, if the second sheath (e.g., the outer sheath) is stiffer than the first sheath (e.g., the inner sheath), the traction lines can provide a greater range of motion.

[0163] like Figure 1 and Figure 7 As shown in each of these, the wire handling system 107 (which may include one or more traction wires) can feed the traction wire 115 through the heated cylinder 102 for positioning along the guide tube. When system 100 (e.g., as...) Figure 1 When the system 101 (as shown) includes a single heated cylinder 102 that allows for multiple passes, the traction line 115 can be positioned after the first sheath is formed and before the second sheath is formed. Figure 7 When the heating cylinder 102 and the auxiliary heating cylinder 103 are included (as shown), the traction line 115 can be configured to be positioned between the heating cylinder 102 and the auxiliary heating cylinder 103 (e.g., between the formation of the first sheath and the second sheath).

[0164] Figure 8An example of a conduit 600 that can be manufactured using system 100 is shown before the removal of substrate 116. Substrate 116 may include a lubricating coating on its outer surface to facilitate removal. The lubricating coating may extend around the circumference of substrate 116. An example of a lubricating coating is a PTFE coating.

[0165] The substrate 116 may be covered with a gasket 602, such as a PTFE layer. The gasket 602 may be positioned above a lubricating coating. The gasket 602 may extend around the circumference of the substrate 116. The gasket 602 may be covered with a braid 604, such as a stainless steel braid layer. The braid 604 may be positioned above the gasket 602. The braid 604 may extend around the circumference of the gasket 602. The braid 604 may be porous. A first sheath 500 may be applied to the braid 604. When the first sheath 500 is formed, the gasket 602 may adhere to the first sheath 500 through the pores in the braid 604.

[0166] As described herein, the first sheath 500 may have one or more cutouts (e.g., see [link to document]). Figure 6 ).like Figure 8 As shown, the incision is filled with a traction line 115 extending along the length of the catheter 600. Subsequently, a second sheath 510 may be formed around the first sheath 500 and the traction line 115.

[0167] In the illustrated embodiment, the catheter 600 includes a first segment 606, a second segment 608, and a third segment 610. Each segment 606, 608, and 610 may have a different hardness. In some embodiments, the first segment 606 may have a high hardness, the third segment 610 may have a low hardness, and the second segment 608 may have a hardness that varies continuously in the longitudinal direction between the hardness of the first and third segments. For example, the first segment 606 may have a Shore hardness equal to 72D, the third segment 610 may have a Shore hardness equal to 35D, and the second segment 608 may have a Shore hardness that gradually changes from 72D to 35D along its length. Furthermore, the first sheath 500 and the second sheath 510 may have the same or different profiles extending in the longitudinal direction.

[0168] Figure 9 The conceptual sectional view shows Figure 8The catheter 600 has no substrate 116 positioned therein. As described herein, a first sheath 500 is formed around a braid 604 and a liner 602. A traction cord 115 is positioned within a portion of the first sheath 500 and is surrounded by a liner 512 (e.g., a PTFE traction cord liner). A second sheath 510 may be formed around the first sheath 500 and the traction cord liner 512. The traction cord 115 may be symmetrically positioned and embedded within the catheter 600. The process of embedding internal components as described herein helps to easily space those internal components in a concentric manner, which can be beneficial for mechanical properties and physician manipulation (e.g., moving the traction cord).

[0169] Figure 10 The use of systems 100 and 101 is shown. Figure 1 and Figure 7 This is an example of a method 800 for additive manufacturing. Method 800 can be used to manufacture implantable medical devices. Method 800 may include, for example, feeding a substrate 802 through a substrate channel in one or more heated barrels. The substrate channel may be in fluid communication with an internal cavity of the heated barrel. Method 800 may include feeding at least a first filament 804 into the internal cavity through a filament port of the heated barrel. Method 800 may include, for example, melting the first filament 806 in the internal cavity. Any portion of the filament housed in the internal cavity may be melted.

[0170] Method 800 may include, for example, moving a heated barrel relative to a substrate 808 in at least the longitudinal direction to form a first sheath comprising material from at least a first filament. The heated barrel or the substrate may also rotate relative to each other. The sheath may be formed of material from at least the first filament. In some embodiments, the sheath may be formed of material from at least the first filament and a second filament. In one or more embodiments, an exit die may have various surface features formed within the outer surface of the first sheath.

[0171] For example, in one or more embodiments, forming the first sheath may include defining one or more protrusions extending from the outer surface of the first sheath. In one or more embodiments, forming the first sheath may include defining one or more channels or cutouts extending inward from the outer surface of the first sheath.

[0172] Method 800 may further include depositing one or more internal components 810 (e.g., relative to features formed on the surface of the first sheath) on the first sheath. For example, one or more components may be deposited between or within the one or more protrusions. Method 800 may further include feeding at least a second filament 812 into an internal cavity through a filament port of a heated barrel, and melting the second filament 814 in the internal cavity of one or more heated barrels.

[0173] Method 800 may include, for example, moving a heated cylinder relative to a substrate 816 at least in the longitudinal direction to form a second sheath comprising material from at least a second filament. The heated cylinder or the substrate may also rotate relative to each other. The sheath may be formed of material from at least the second filament. In some embodiments, the sheath may be formed of material from at least the first and second filaments. As described herein, the first and second sheaths may be formed from a single heated cylinder that passes multiple times along the substrate, or from two separate heated cylinders spaced apart from each other.

[0174] The exemplary leads described herein may include innovative electrode designs and connections between such electrodes and conductor wires to reduce outer diameter. Furthermore, the exemplary leads may not utilize the insulating core tubing typically used between the electrodes and the coils and / or sheaths of existing leads. In one embodiment, the exemplary lead uses platinum-ruthenium electrodes, a 004Ag / MP 35nw / Si conductor coil, a polyurethane lead body, and a monolithic controlled release device (MCRD) silicon ring.

[0175] The exemplary leads described in this article can be thinner than current leads for better tracking into small vessels (e.g., better trackability). Furthermore, exemplary leads can have better "pushability" and utilize approximately 80% less force when placed in a curved path than existing leads. Additionally, while the outer diameter of exemplary leads can be reduced (e.g., 3Fr, less than 3Fr, etc.), the leads remain compatible with current delivery systems (e.g., 0.014-inch guidewires), meaning physicians may not need to change their clinical practice to implant these exemplary leads. Moreover, exemplary leads can improve CRT response by targeting optimal pacing options unattainable with other leads. Furthermore, exemplary leads have the potential to be used in other pacing therapies, such as hypoglossal nerve stimulation for sleep apnea.

[0176] Additionally, compared to thicker leads, thinner leads (e.g., smaller outer diameter, such as less than 4 Fr or less) may reduce the contact between the electrode and the coronary vessel wall. Therefore, the pacing capture threshold (PCT) used with thinner leads may tend to be higher, potentially leading to faster battery depletion.

[0177] The exemplary leads described herein are designed to overcome the challenges of thinner leads (e.g., less than 4 Fr, less than 3 Ft, etc.) to reduce PCT and ensure that the leads can deliver acceptable electrical signals without impairing battery life. Typically, such leads utilize platinum-ruthenium electrodes, polyurethane tubing shaped with a specific design, and a conductive inner coil.

[0178] As described herein, exemplary leads may include a lead body that serves directly as an insulating core. The electrode may be a single-part platinum-ruthenium tube with a slit. In one or more embodiments, exemplary leads may be manufactured, fabricated, or formed by cutting a slit in the lead body and extending the lead beyond the lead body. The lead body may then be thermally bonded by more than 2 mm to reduce the outer diameter of the section where the electrode will be positioned. The thermal bonding process may also close the previously formed slit that allows the wire to extend. The electrode may be slightly opened (e.g., using the slit) and slid across the lead body until the electrode reaches the reduced diameter section. The lead may then optionally be externally soldered to the electrode. Finally, the electrode may be closed by deforming (e.g., curling) and then soldering the slit.

[0179] In view of this, Figures 11 to 17 Various exemplary leads and their constructions are depicted, which can provide finer guides that can better navigate small, tortuous paths (such as some coronary vessels) compared to previous leads. For example, in Figure 11 The text describes the ability to use relative to... Figures 1 to 6 The described system and method fabricate an exemplary quadrupole lead 900. Lead 900 can extend from a proximal end to a distal end 904. Figure 11 The image depicts a distal region extending a selected length from the distal end 904 toward the proximal end.

[0180] In this embodiment, lead 900 may include four electrodes 906 coupled to lead body 901. It should be understood that other embodiments similar to lead 900 may include fewer or more than four electrodes. Specifically, lead 900 includes a tip electrode 906A and three annular or body electrodes 906B, 906C, and 906D. Tip electrode 906A is located at the distal end 904 of lead 900 for maximum positioning along a blood vessel, while the remaining annular electrodes 906B, 906C, and 906D may be distributed along the blood vessel. Electrodes 906 may include one or more conductive materials to sense cardiac electrical activity and deliver cardiac electrotherapy to cardiac tissue. For example, electrode 906 may include one or more of platinum, platinum alloys, and / or other materials known for use in implantable electrodes.

[0181] The ring electrodes 906B, 906C, and 906D may be spaced apart along the lead body 901 to provide various sensing and pacing positions, for example, when the lead 900 is implanted. Additionally, as shown, the lead 900 may include a coil-type fixation element 909 located near the ring electrode 906D. The fixation element 909 may be configured to secure or attach the lead 900 to cardiac tissue to prevent movement of the lead 900 after it has been positioned in the desired location (e.g., to position the electrode 906 in an acceptable location to provide the desired sensing and pacing capabilities for the selected therapy).

[0182] Lead 900 can be thinner or have a smaller diameter 911 compared to typical leads. For example, lead 900 can be less than 4 French (4Fr), with a diameter less than 1.333 mm. Furthermore, lead 900 can be, for example, 3Fr, with a diameter of 1 mm. Furthermore, lead 900 can be, for example, 3.5Fr, with a diameter of 1.166666 mm. Furthermore, lead 900 can be less than 3Fr. To facilitate small size or diameter of lead 900, this disclosure describes electrode connection constructions (or arrangements) and methods of manufacturing such leads, which will be described relative to... Figures 12 to 15 describe.

[0183] exist Figure 12 It is described Figure 11 An enlarged cross-sectional view of an exemplary toroidal electrode 906C of the quadrupole lead 900 is shown. As shown, the toroidal electrode 906C is positioned around the lead body 901, and additionally, a coil conductor 910 is located within a cavity 907 of the lead body 901. The coil conductor 910 is electrically and mechanically connected to the toroidal electrode 906C, as will be further described herein.

[0184] in addition, Figures 11 to 12 The lead 900 shown also includes monolithic controlled release devices (MCRDs) 905, each located near one of the electrodes 906. The MCRDs 905 may be integrated with or separate from the electrodes 906, and may be coupled to the lead body 901 in the same or similar manner as the electrodes 906.

[0185] exist Figures 13A to 13E The diagram depicts a cross-sectional view illustrating an exemplary method of connecting electrode 906C to lead body 901. First, lead body 901 is provided. It can be used with respect to the present invention. Figures 1 to 10 The additive manufacturing system and process described are used to manufacture or form lead body 901. Typically, this is similar to... Figure 11As described, the lead body 901 can extend from a proximal end to a distal end 904 and define a lumen 907. Furthermore, the conductor 910 can be positioned within the lumen 907.

[0186] It should be understood that, Figures 13A to 13E Only a small portion or region of the lead 900 is depicted to show or illustrate the connection between the electrode 906C and that small portion or region of the lead. In one embodiment, Figures 13A to 13E A small portion or region of the lead 900 depicted includes two different diameters for two different regions of the lead body 901. Specifically, the lead body 901 includes an extension region 912 and an electrode connection region 914. The electrode connection region 914 is where the electrode 906C is connected to the lead body 901. The extension region 912 defines a first outer diameter 913, and the electrode connection region 914 defines a second outer diameter 915 smaller than the first outer diameter 913. For example, the first outer diameter may be between about 0.75 mm and about 1.25 mm, and the second outer diameter may be between about 0.5 mm and about 1 mm. In at least one embodiment, the first outer diameter may be about 3 mm or 1 mm, and the second outer diameter may be about 0.7 mm.

[0187] The electrode connection region 914 may provide a recess or space 919 to receive the annular electrode 906C, such that, for example, when the annular electrode 906C is attached to the outer surface 920 of the lead body 901, the outer surface of the lead body can be substantially flush with the outer surface 928 of the annular electrode 906C. The recess 919 may define a depth that is the difference between a first outer diameter 913 and a second outer diameter 915. Furthermore, as shown in this embodiment, the recess 919 may further define a sloped side that transitions the electrode connection region 914 to the extension region 912, corresponding to the sloped side of the electrode 906C, which in... Figures 13C to 13D As shown in the figure. In other embodiments, the recess 919 may have straight sidewalls.

[0188] As described herein, the lead body 901, including the extension region 912 and the electrode connection region 914, can be used in accordance with the present invention. Figures 1 to 10 The additive manufacturing system and process are used to form or manufacture. For example, when forming or producing the electrode connection region 914, less material can be applied to the substrate (e.g., rod, mandrel, core, conductive coil wound on the substrate, etc.) compared to when forming the extension region 912 to define a second outer diameter 915 smaller than the first outer diameter 913.

[0189] Next, the opening 952 can be defined to pass through the lead body 901, and the connection portion or segment 950 of the coil conductor 910 can be extended to the outside of the lead body 901. In this example, the opening 952 is formed in the electrode connection region 914 of the lead body 901. More specifically, the opening 952 can be made to extend from the outside through the wall of the lead body 901 to the lumen 907 of the lead body 901.

[0190] In one or more embodiments, the opening 952 through which the connection portion 950 of the coil conductor 910 extends may be closed or “filled”. For example, the electrode connection region 914 may be thermally bonded, which may allow the polymer of the lead body 901 to flow back, thereby closing or filling any remaining gaps around the opening 952 of the conductor 910 through which the conductor extends.

[0191] Then, the annular electrode 906C can be positioned in the electrode connection region 914, near the conductor outside the lead body 901. Figure 15 An exemplary annular electrode 906, or pre-fixation electrode 906, is depicted before being fixed to the lead body 901. As shown, the pre-fixation electrode 906 may define a C-shape. More specifically, the pre-fixation electrode 906 may extend circumferentially from a first end 930 to a second end 932 and define a gap 931 between the first end 930 and the second end 932. Furthermore, the annular electrode 906C, before being fixed to the lead body 901, may be described as defining an inner surface 926, an outer surface 928, and a thickness 927 between the inner surface 926 and the outer surface 928. The thickness 927 of the annular electrode 906C, before being fixed to the lead body 901, is less than or equal to half the difference between the first outer diameter 913 and the second outer diameter 915 of the lead body 901.

[0192] The annular electrode 906C may define a C-shape. More specifically, the annular electrode 906C may define an inner diameter slightly larger than the first outer diameter 913 of the extension region 914 of the lead body 901, for example, so as to allow movement about the lead body. Thus, as... Figures 13C to 13D As shown, the C-shaped annular electrode 906C can be slid down along the lead body 901 to or on the lead body to the electrode connection area 914.

[0193] The annular electrode 906C can then be mechanically coupled to the lead body 901 and electrically coupled to the coil conductor 910 (specifically, a section or portion of the coil conductor 910 extending outside the lumen 907 of the lead body 901). The electrode 906C can be mechanically coupled to the lead body 901 in various ways. In at least one example, the electrode 906C can be deformed or radially inwardly compressed as indicated by arrow 939 to reduce the inner diameter of the annular electrode 906C, thereby contacting and securing the inner surface 926 to the outer surface 920 of the lead body 901. In one or more embodiments, in doing so, the gap 931 defined between the first end 930 and the second end 932 can be closed. In other words, mechanically coupling the C-shaped electrode 906C to the lead body 901 can include applying a force, as indicated by arrow 939, to the C-shaped electrode 906C to deform the C-shaped electrode 906C to close the gap 931, such that the first end 930 contacts the second end 932.

[0194] Similarly, electrode 906C can be electrically connected to coil conductor 910 in various ways. For example, the mechanical connection described herein may be sufficient to press the inner surface 926 of coil conductor 910 and annular electrode 906C into contact to provide a durable, acceptable electrical connection between the coil conductor and the inner surface of the annular electrode. Furthermore, for example, electrode 906C and coil conductor 910 can be laser-welded together to electrically connect them to each other. In at least one embodiment, laser welding is applied to the outer surface of the C-shaped electrode to electrically connect the inner surface 926 to coil conductor 910.

[0195] As a result, the outer surface 928 of electrode 906C can be flush with or substantially flush with the outer surface 920 of the extension region 914 of lead body 901, such as Figure 13E As shown in the diagram. Therefore, after the electrode 906C has been attached to the electrode attachment region 914 of the lead body 901, the electrode attachment region of the lead body can be defined with a diameter less than or equal to about 1.33333 mm (e.g., 1.0 mm).

[0196] In addition, although Figures 11 to 1 The embodiment described in section 3 utilizes a ring electrode 906; however, it should be understood that the lead 900 can also utilize a coil electrode 916 and a C-shaped electrode 917, as shown below. Figure 27 As depicted herein. More specifically, for example, coil 916 may be electrically connected (e.g., soldered) to C-shaped electrode 917, which may be electrically connected to coil conductor 910 via body 901 and, for example, in relation to this text. Figures 13A to 13EThe coil electrode 916 is mechanically coupled to the body 901 in a similar manner. For example, as shown, the coil electrode 916 and the ring electrode 917 are positioned in a recess such that the outer side of the coil electrode 916 is flush with the outer surface 920 of the body 901. The coil electrode 916 can be described as providing support for thinner (e.g., 3Fr) leads to maintain a stable, stabilizing effect. Figures 16 to 17 The S-shape shown.

[0197] exist Figures 14A to 14E The image depicts a photographic side view illustrating an exemplary method of connecting electrodes to a quadrupole lead. (See image.) Figure 14A As shown, a lead body can be provided that includes an electrode connection region (e.g., a recess). An opening can be made (e.g., formed) through the lead body, and a coil conductor can extend through this opening, such as... Figure 14B As shown in the diagram. After the coil conductor extends through the opening, the lead body can be thermally bonded to allow the polymer to flow back and seal the opening. C-shaped electrodes can be used as... Figure 14C As shown, slide or move along the lead body, and then as... Figure 14D The C-shaped electrode is electrically connected to the coil conductor, as shown (e.g., by welding). Finally, the C-shaped electrode can be deformed by bending, such as... Figure 14E As shown, the electrodes are mechanically connected to the lead body.

[0198] The illustrative fine leads described herein (e.g., defined as having an outer diameter of less than 1.333 mm) can have various shapes and configurations. Figures 16 to 17 Some illustrative shapes and configurations are depicted in the text. Figure 16 The lead 1000 can be described as having a lead body 1001 that extends from a proximal end 1002 to a distal end 1004 and defines an S-shaped region 1005 near the distal end 1004, a first vertex region 1007 within the S-shaped region, and a second vertex region 1009 within the S-shaped region.

[0199] Each vertex region 1007, 1009 can be described as a region of the lead body 1001 that deviates from the central axis 1010 by the maximum distance. More specifically, the lead body 1001 can be described as further defining a straight portion 1011 located near the S-shaped region 1005. When undeflected, the straight portion 1011 may extend along and define the central axis 1010. When undeflected, one or both of the first vertex region 1007 and the second vertex region 1009 may be located at a larger vertical radial distance away from the axis 1010 compared to any other remaining portion of the lead body 1001. Additionally, it can be described that the first vertex region 1007 is located on the side of the axis 1010 opposite to the second vertex region 1009.

[0200] Furthermore, each of the vertex regions 1007 and 1009 can be centered within one of the curved portions 1006 and 1008 of the S-shaped region 1005. In this example, the first curved portion 1006 defines a first radius 1012, and the second curved portion 1008 defines a second radius 1014, and the second radius 1014 is the same as the first radius 1012 when the leader 1000 is not deflected.

[0201] Lead 1000 can be described as a quadrupole lead because it includes four electrodes. It should be understood that lead 1000 may include more or fewer than four electrodes. Specifically, as shown, lead 1000 includes a tip electrode 1020, a first coil electrode 1022, a second coil electrode 1024, and a ring electrode 1026. Tip electrode 1020 is located and connected to the distal end 1004 of lead body 1001. First coil electrode 1022 is connected to lead body 1001 and positioned at a first vertex region 1007, and second coil electrode 1024 is connected to lead body 1001 and positioned at a second vertex region 1009. The positioning of coil electrodes 1022 and 1024 at vertex regions 1007 and 1009 facilitates consistent contact with the vessel wall for purposes such as sensing signals from the vessel wall, delivering pacing therapy to the vessel wall, etc.

[0202] in other words, Figure 16 The illustrative lead 1000 depicted can be described as a combination of an S-shaped 3Fr lead and coil electrodes 1022, 1024. Coil electrodes 1022, 1024 allow for better compliance with the curved lead body and the vessel wall. In other words, coil electrodes 1022, 1024 can maintain or retain flexibility, and therefore electrodes 1022, 1024 can be designed to be longer than typical tubular annular electrodes. Furthermore, coil electrodes 1022, 1024 can be placed or positioned at the apex regions 1007, 1009 of the S-shape 1005 to ensure contact between the coil electrodes 1022, 1024 and the blood vessel. Specifically, the S-shape 1005 will press the coil electrodes 1022, 1024 against the coronary vessel wall.

[0203] Figure 17 The lead 1000 can be described as having a lead body 1101 that extends from a proximal end 1102 to a distal end 1104 and defines an S-shaped region 1105 near the distal end 1104, a first vertex region 1107 within the S-shaped region 1105, and a second vertex region 1009 within the S-shaped region 1105.

[0204] Each vertex region 1107, 1109 can be described as a region of the lead body 1101 that deviates from the central axis 1110 by the maximum distance. More specifically, the lead body 1001 can be described as further defining a straight portion 1111 positioned near the S-shaped region 1005. When undeflected, the straight portion 1111 may extend along and define the central axis 1010. When undeflected, one or both of the first vertex region 1107 and the second vertex region 1109 may be positioned at a larger vertical radial distance away from the axis 1110 compared to any other remaining portion of the lead body 1101. Additionally, it can be described that the first vertex region 1107 is located on the side of the axis 1110 opposite to the second vertex region 1109.

[0205] Furthermore, each of the vertex regions 1107 and 1109 can be centered within one of the three curved portions 1106, 1108, and 1103 of the S-shaped region 1105. In this example, the first curved portion 1106 defines a first radius 1112 and the second curved portion 1008 defines a second radius 1114, and the second radius 1114 is larger than the first radius 1112 when the leader 1000 is not deflected. Additionally, the end curved portion 1103, away from the first curved portion 1106, can define a third radius 1115 smaller than the first radius 1112.

[0206] Lead 1100 can be described as a quadrupole lead because it includes four electrodes. It should be understood that lead 1100 may include more or fewer than four electrodes. Specifically, as shown, lead 1100 includes a tip electrode 1120, a first coil electrode 1122, a second coil electrode 1124, and a ring electrode 1126. Tip electrode 1120 is located at and connected to the distal end 1104 of lead body 1101. First coil electrode 1122 is connected to lead body 1101 and positioned at a first vertex region 1107, and second coil electrode 1124 is connected to lead body 1101 and positioned at a second vertex region 1109. The positioning of coil electrodes 1122 and 1124 at vertex regions 1107 and 1109 facilitates consistent contact with the vessel wall for purposes such as sensing signals from the vessel wall, delivering pacing therapy to the vessel wall, etc.

[0207] Figure 17 The illustrative lead 1100 depicted in the diagram can be described as similar to Figure 16 The lead 1000, except that the radii of the curved portions 1108, 1106, and 1103 of the S-shape 1105 decrease towards the distal end 1104 along the length of the lead. The two distal electrodes 1120 and 1122, compared to the remaining electrodes 1124 and 1126, can be placed in smaller vessels, which can be located in larger, more proximal segments of the coronary artery. Along... Figure 17 The illustrative lead 1100's reduced curve radius provides the lead 1100 with the ability to adapt to different blood vessel diameters.

[0208] generally, Figures 16 to 17 The exemplary leads can lower the pacing capture threshold, provide better contact between the electrode and the vessel wall, provide flexible electrodes that conform to the curvature of the lead body and the vessel wall, adapt to the variability in diameter on the coronary artery, and provide better tracking capability in curved vessels due to the flexibility of the coil electrode.

[0209] This disclosure provides various design-based methods for creating alignment or targeting features within delivery systems, catheters, sheaths, leads, or similar devices. Additionally, the invention can be applied to valve delivery, stent, or any other implant delivery system. In one or more embodiments, it can be described that this disclosure utilizes one or more markers (e.g., radiopaque markers, echo markers, etc.) having a specific geometric design (e.g., hemispherical rings, annular rings / marker bands, or other shapes) that can be used to create a target reference shape during alignment. When in different imaging planes (e.g., fluoroscopy, ultrasound, etc.), the markers can be spaced apart and aligned to provide different target reference shapes or images. When the markers are correctly aligned, the catheter, lead, or other implantable device can be positioned 90 degrees to the target site (e.g., the target site can be a substantially planar wall, such as a septum wall). Therefore, the alignment of markers with 90-degree opposite each other can be described as providing a visual signal (e.g., a reference shape) to the implant physician within the image, thereby indicating that the catheter, lead, or other implantable device is correctly aligned before, for example, fixing or deploying device screws, so as to deploy the lead or catheter or device in the preferred target location at the appropriate desired angle.

[0210] Another approach would be to use one marker on the delivery catheter shaft and another marker on the lead delivered by the delivery catheter. The proximal marker could be located on the delivery catheter shaft, and the distal marker could be located on the lead body. Alternatively, the proximal marker could also be located on the lead body, and the distal marker could be located on the delivery catheter shaft. Both options result in the markers forming a "target" reference shape when the delivery catheter and lead are properly aligned.

[0211] This disclosure can be described as making difficult implantation procedures significantly easier because it provides visual signals (e.g., reference shape) to the implanter, indicating that the implanter is properly aligned for the deployment of the therapy. This translates into a significant reduction in complications, procedure time, and procedure / implanter efficacy, leading to the use of fewer devices and better outcomes for the patient. The simplification of the delivery process for implantable cardiac devices, particularly by utilizing existing technologies with novel modalities to produce repeatable and predictable implants, is valuable and may lead to more efficient procedures, better patient outcomes, and reduced implantation time.

[0212] Furthermore, this disclosure can be described as providing marker strips that, when aligned in a prescribed fluoroscopic or ultrasound projection, aid in the navigation of the implant toward a desired target site or structure. In one or more embodiments, the described techniques incorporate the use of radiopaque or echogenic materials integrated into the design of the delivery system or implantable device, along with methods for guiding the implant physician in using and aligning delivery tools for ideal fixation or implantation of the device. These markers, when used in a prescribed orientation, can guide and assist in three-dimensional navigation of the implant while the implant is being viewed in two-dimensional images (e.g., fluoroscopic or echogenic images).

[0213] In at least one embodiment, this disclosure provides a method for using preoperative or intraoperative imaging (e.g., computed tomography (CT), ultrasound, etc.) to identify general structures or points within the anatomical structure relevant to the implantation procedure. This may include, in particular, septal wall thickness, septal wall angle relative to the tricuspid valve plane, right ventricular orientation and size, etc. Furthermore, the method may include selecting an appropriate device for implantation with suitable specifications, which may include lead length, catheter length, catheter shape, etc. The method may further include using simple tools, algorithms, and tip cards for preoperative planning based on imaging views from previous steps or procedures.

[0214] In embodiments where an implantable electrode will be implanted in the septum for, for example, delivery of cardiac conduction system pacing therapy, the method may include typical access surgery to navigate and deliver the device (e.g., delivery catheter, lead, etc.) to the right ventricle. Additionally, in one or more embodiments, the His bundle may be mapped to, for example, confirm the generalized implant location and establish isocentric orientation of the right anterior and left anterior oblique fluoroscopic planes, which may have been determined preoperatively or during intraoperative imaging. The imaging plane formed preoperatively can be confirmed and can be adjusted during the implantation procedure. The method may then include moving the device to the target location and aligning markers (e.g., radiopaque markers, echo markers, etc.) during “real-time” observation using imaging. Once the markers are aligned as shown in the imaging plane, the device can be deployed and secured at the target site or location.

[0215] In one or more embodiments utilizing an echo-guided catheter, transthoracic echocardiography (TTE) can be used to obtain optimal four-chamber, short-axis, and other relevant views displaying the intracardiac septum (IVS). Alternatively, TEE or intracardiac echocardiography (ICE) can be used to achieve similar relevant views to guide the procedure. Furthermore, the device can be tracked to the target location using a distal region or feature coated with echo material, and the position and orientation of the device's distal tip can be assessed using imaging views. Based on the imaging, the device position and orientation can be adjusted to achieve a perpendicular alignment of the device with the septum, and the device can then be deployed and secured at the target site or location.

[0216] In other words, in one embodiment, when the distal region of an implantable device (such as a delivery catheter or lead) comprising two or more alignment marker elements is perpendicularly aligned with a target location (such as a septum), the marker elements can produce a reference shape known to the implanter (e.g., a circle, a hole, an observation ring, etc.). Therefore, when imaging is observed during implantation, the implanter will know whether the implantable device is properly aligned for implantation or delivery. This disclosure can be described as being able to reduce implanter complexity and provide greater surgical efficiency and predictability, which will reduce complications and save valuable resources for hospital systems. Additionally, in one or more embodiments, when two or more alignment marker elements are not perpendicularly aligned to the target location (such as a septum), the marker elements can produce a non-alignment reference shape (e.g., overlapping circles or portions of circles, interlaced rings, arrows, etc.) to indicate to the implanter that the implantable device is misaligned or not perfectly aligned. Furthermore, the non-alignment reference shape may include features that allow the implanter to understand that the implantable device can be moved, bent, or otherwise manipulated to position the implantable device in a properly aligned orientation.

[0217] In view of this, Figure 18 An exemplary lead 1200 implanted in a patient's heart 12 is shown. More specifically, the lead 1200 may extend into the patient's heart 12 to sense electrical activity of the heart 12 and / or deliver electrical stimulation to the heart 12, and particularly, to sense electrical activity and / or deliver electrical stimulation to the ventricular septum 10 of the heart 12. For example, the lead 1200 may be configured to deliver cardiac conduction system pacing therapy from a location within the septum 10 to the left and / or right bundle branches, His bundle, etc. Furthermore, for example, the lead 1200 may be configured to deliver conventional myocardial pacing therapy from a location within the septum 10 to the left and / or right ventricular myocardial tissue. Figure 18 In the example shown, lead 1200 extends through one or more veins (not shown), the superior vena cava (not shown), the right atrium 26, and into the right ventricle 28. Lead 1200 is then positioned adjacent to the septum 10 in the right ventricle 28. Additionally, although in Figure 18A single lead is depicted, but it should be understood that lead 1200 can be used with one or more additional leads or leadless devices configured to sense electrical activity and / or deliver pacing therapy to the left ventricle, right ventricle, right atrium, etc. For example, lead 1200 can be used in conjunction with a conventional left ventricular coronary sinus lead extending through one or more veins, vena cava, right atrium 26 and into the coronary sinus 30 to reach a region adjacent to the free wall of the left ventricle 32 of heart 12, and / or a right atrial lead extending through one or more veins and vena cava and into the right atrium 26 of heart 12.

[0218] Additionally, as illustrated, lead 1200 can be operatively coupled to implantable medical device (IMD) 16. IMD 16 can sense electrical signals accompanying depolarization and repolarization of the heart 12 via electrodes coupled to lead 1200 or another lead (such as a left ventricular lead, right atrial lead, etc.). In some examples, IMD 16 delivers pacing therapy (e.g., pacing pulses) to the heart 12 based on the electrical signals sensed within the heart 12. IMD 16 can be operable to adjust one or more parameters associated with the pacing therapy, such as, for example, AV delay and various other timing, pulse width, amplitude, voltage, burst length, etc. Furthermore, IMD 16 can be operable to deliver pacing therapy using various electrode configurations, which can be monopolar, bipolar, quadrupole, or other multipolar configurations. For example, a multipolar lead may include several electrodes that can be used to deliver pacing therapy. Thus, a multipolar lead system can provide or supply multiple electrical vectors for pacing. A pacing vector may include at least one cathode and at least one anode, wherein the at least one cathode may be at least one electrode located on at least one lead, and the at least one anode may be at least one electrode located on at least one lead (e.g., the same lead or different leads) and / or on the housing or casing of the IMD. While improvements in cardiac function as a result of pacing therapy may depend primarily on the cathode, electrical parameters such as impedance, pacing threshold voltage, current consumption, and lifespan may be more dependent on the pacing vector, which includes both the cathode and the anode.

[0219] The septal pacing lead 1200 can be described as including a body 1201 extending from a proximal region 1202 to a distal region 1204. The proximal region or portion 1202 may be located near the IMD 16 for operatively coupling to the IMD, and the distal region or portion 1204 may be located or positioned at a target site. Figure 18 The example depicted is the ventricular septum 10.

[0220] In the depicted embodiment, the distal region 1204 may extend along a distal region axis 1205. More specifically, the distal region axis 1205 may be a straight, uncurved line, along which the distal region 1204 may extend, and thus the distal region 1204 may also define a straight, uncurved line. In other embodiments, the distal region 1204 may not extend along an axis and may, for example, define a variety of different shapes or curves, and the alignment marker elements further described herein may be configured to take into account the shape and curvature of the distal region 1204.

[0221] exist Figure 19A The distal region 1204 of the lead 1200 is depicted. As shown in this embodiment, the lead 1200 also includes two alignment marker elements 1210A, 1210B coupled to the body 1201. Each alignment marker element 1210 defines a complementary shape to the other alignment marker element, such that when the distal region 1204 is viewed axially, the two alignment marker elements 1210 form a reference shape that indicates an acceptable alignment of the distal region 1204 for positioning at a target site (e.g., alignment with the target site).

[0222] Alignable marker element 1210 may include one or more materials that are image-capable (e.g., capable of tissue imaging) when located inside a patient (such as, for example, when located inside a patient's heart). For example, alignment marker element 1210 may include one or more of a radiopaque material visible by fluorescence fluoroscopy, an echogenic material visible by ultrasound, etc. Radiopaque materials may include one or more of gold, platinum, platinum / iridium, titanium, tantalum, barium silicate, barium tungsten, barium sulfate, bismuth trioxide, bismuth oxychloride, bismuth subcarbonate, and / or combinations or compounds thereof. Echogenic materials may include one or more of perfluorinated carbon, coated tungsten, tungsten carbide particles distributed within a base polymer material, etc.

[0223] The alignment marker element 1210 may be partially or completely embedded within the body 1201 of the lead 1200, such that some or no portions of the alignment marker element 1210 may be exposed to, for example, bodily fluids, tissues, etc. In one embodiment, the alignment marker element 1210 may also provide other functions, such as pacing and / or sensing electrodes, and thus may be electrically connected to a circuit including the conductor and the IMD 16.

[0224] The distal region 1204 may define a distal region length 1207 that can vary depending on the application. The distal region 1204 may be defined by a portion of the lead body 1201 extending in a straight line along the distal region axis 1205. In this application, from the pacing diaphragm 10 of the right ventricle 28, the distal region length 1207 may be between approximately 5 mm and approximately 20 mm. Additionally, the alignment marker elements 1210 may be spaced apart from each other by a spacing distance 1209. In other words, the farthest alignment marker element 1210A, which may be referred to as the distal alignment marker element 1210A, may be located at a spacing distance 1209 away from the nearest alignment marker element 1210B (which may be referred to as the proximal alignment marker element 1210B). Similar to the distal region length 1207, the spacing distance 1209 may vary depending on the application. In this application, the spacing 1209 of the pacing septum 10 extending from the right ventricle 28 can be between about 3 mm and about 30 mm. In at least one embodiment, the spacing 1209 is 10 mm. Furthermore, depending on the target site and the tolerance for implantation at the target site, the spacing 1209 can be selected and / or the shape and size of the alignment marker element can be adjusted. For example, when the lead is implanted into the ventricular septum, acceptable alignment can be within 20% to substantially perpendicular to the septum. Therefore, the spacing 1209 can be selected and / or the size and shape of the alignment marker element 1210 can be adjusted to achieve a 20% perpendicularity for that implantation site.

[0225] Furthermore, the distally alignable marker element 1210A can be located near the distal end 1203 of the lead 1200, which can be configured to be adjacent to or in contact with the target site or location when the lead 1200 is properly implanted. Additionally, although in Figure 19A Not shown in the text but Figure 18 As shown, lead 1200 may further include a retaining element 1215 extending from distal end 1203, the retaining element being configured to secure or attach distal end 1203 of lead 1200 to a target site. In one embodiment, retaining element 1215 may be a helical retaining element that can be "screwed" into tissue such as septum 10.

[0226] As described herein, each of the alignment marker elements 1210 defines a complementary shape to the other alignment marker element, such that when the distal region 1204 is viewed axially, the two alignment marker elements 1210 form a reference shape that indicates acceptable alignment of the distal region 1204 for positioning at the target site. The complementary shapes of the alignment marker elements 1210 can be virtually any shape or size to provide the ability to determine whether the distal region 1204 is properly aligned at the target site when viewed axially (e.g., along the distal region axis 1205, in an imaging plane perpendicular to the distal region axis 1205, etc.). Additionally, as will be further described herein, the complementary shapes of the alignment marker elements 1210 can be virtually any shape or size to provide the ability to determine in what directions the distal region 1204 is not aligned with the target site when viewed axially (e.g., along the distal region axis 1205, in an imaging plane perpendicular to the distal region axis 1205, etc.).

[0227] For example, Figure 19A The complementary shape of each of the two alignable marker elements 1210 is a semicircle. The semicircular shape of the proximal alignable marker element 1210B opens in the opposite direction to the semicircular shape of the distal alignable marker element 1210A. Therefore, when Figure 19A When the distal region 1204 is imaged axially, the reference shape will be a combination of two opposing semicircles, i.e., a single circle. Additionally, when Figure 19A When imaging the distal region 1204 off-axis, the two opposing semicircles will not combine to form or define a single circle, and therefore no reference shape is provided.

[0228] exist Figure 19B Another example is depicted where each of the two alignable marker elements 1210 has the same complementary shape, namely a circle. Therefore, when Figure 19B When the distal region 1204 is imaged axially, the reference shape will be a combination of two circles, i.e., a single circle. Additionally, when Figure 19B When imaging the distal region 1204 off-axis, the two circles of the two alignable marker elements 1210 will not be combined to form or define a single circle, but will instead depict two separate circles or two circles that only partially overlap, and therefore will not provide a reference shape.

[0229] Other examples of complementary shapes that can be aligned with marker elements may include full or partial triangles, pentagons, squares, rectangles, alphanumeric symbols, "puzzle" shapes, zigzags, etc.

[0230] exist Figure 20A and Figure 20BThe image depicts a scene including... Figure 19B A simulated right anterior oblique (RAO) fluorescence fluoroscopic image of the leads 1200 of the two alignable marker elements 1210, taken at a 20-degree offset from the septum. As shown, the distal region 1204 in... Figure 20A The two alignment marker elements 1210 (both circular) do not even partially overlap to produce a single circular reference shape. Instead, the simulated RAO fluorescence fluoroscopic image clearly shows two separate circles, each from a different alignment marker element 1210, thus indicating that the distal region 1204 is not perpendicularly aligned with the RAO imaging plane.

[0231] Conversely, in the remote region 1204 Figure 20B Alignment is achieved because two alignable marker elements 1210 (both circular) overlap to produce a single circular reference shape. More specifically, the simulated RAO fluorescence perspectral image clearly shows a single circle, or a shape formed by partially overlapping circles, in contrast to the two individual circles, thus indicating that the distal region 1204 is aligned perpendicular to the RAO imaging plane.

[0232] Figures 21-23 depict another exemplary lead 1200, which includes two alignment marker elements 1210, each having a complementary shape that is a complete circle. More specifically, an illustrated side view of the distal lead region 1204 relative to the target region and an exemplary image taken perpendicular to the target region are shown, wherein the distal lead region 1204 is... Figure 21A and Figure 21B Center alignment and Figure 22A and Figure 22B The center is misaligned. More specifically, such as... Figure 21A As shown, the distal region axis 1205 of the distal region 1204 is substantially perpendicular to the target site 1250, such as the ventricular septum, and therefore perpendicular to... Figure 21B The images of the target area depicted in the text depict the reference shape of a single circle. Furthermore, as... Figure 22B As shown, the distal region axis 1205 of the distal region 1204 is not substantially perpendicular to the target site 1250, such as the ventricular septum (e.g., instead, the distal region axis 1205 is offset from the vertical by approximately 30 degrees), and therefore, perpendicular to... Figure 22B The images of the target area depicted in the text do not depict the reference shape of a single circle, but rather two separate circles.

[0233] exist Figure 23A The image depicts a scene as shown in the diagram. Figure 21A A simulated right anterior oblique (RAO) fluorescence fluoroscopic image of the distal lead region 1204, aligned centrally and taken at a 20-degree angle perpendicular to the septum. (See image in...) Figure 23AAs can be seen in the image, there exists a reference shape for a single circle indicating alignment. Conversely, in Figure 23B The text shows that in Figure 22A The image depicts a simulated RAO fluorescence transmission image taken at a 20-degree angle perpendicular to the septum, showing the misaligned distal lead region 1204. (See also...) Figure 23B As can be seen in the image, there is no single circle as the reference shape; instead, there are two separate circles indicating an unacceptable alignment.

[0234] Figures 24-26 depict another exemplary lead 1200, which includes two alignable marker elements 1210, each having a complementary shape of opposing semicircles (e.g., these semicircles face each other with their open sides facing each other). More specifically, a schematic side view of the distal lead region 1204 relative to the target portion and an exemplary image taken perpendicular to the target portion are shown, wherein the distal lead region 1204 is... Figure 24A and Figure 24B Center alignment and Figure 25A and Figure 25B The center is misaligned. More specifically, such as... Figure 24A As shown, the distal region axis 1205 of the distal region 1204 is substantially perpendicular to the target site 1250, such as the ventricular septum, and therefore perpendicular to... Figure 24B The images of the target area depicted in the text show the reference shape of a single circle. Furthermore, as... Figure 24B As shown, the distal region axis 1205 of the distal region 1204 is not substantially perpendicular to the target site 1250 (e.g., the ventricular septum) (e.g., instead, the distal region axis 1205 is deviated from the vertical by approximately 30 degrees), and therefore, perpendicular to... Figure 25B The images of the target area depicted in the text do not depict the reference shape of a single circle, but rather two separate semicircles spaced apart from each other.

[0235] exist Figure 26A The image depicts a scene as shown in the diagram. Figure 24A A simulated right anterior oblique (RAO) fluorescence fluoroscopic image of the distal lead region 1204, aligned centrally and taken at a 20-degree angle perpendicular to the septum. (See image in...) Figure 26A As can be seen in the image, there exists a reference shape for a single circle indicating alignment. Conversely, in Figure 26B The text shows that in Figure 25A The image depicts a simulated RAO fluorescence transmission image taken at a 20-degree angle perpendicular to the septum, showing the misaligned distal lead region 1204. (See also...) Figure 26B As can be seen in the image, there is no reference shape for a single circle, but rather two separate semicircles spaced apart from each other, indicating unacceptable alignment.

[0236] exist Figures 28A to 28CAnother exemplary lead 1300 is depicted, aligned relative to a target portion 1250 and including two alignable marker elements 1310, each having a complementary shape. The first alignable marker element 1310A includes two arcuate portions of a circle, and the second alignable marker element 1310B includes a single arcuate portion of a circle or semicircle. Figure 28C The diagram shows a cross-sectional view of the lead body 1301, including the first alignable marker element 1310A, taken along line 1399, and... Figure 28B The image shows a cross-sectional view of the lead body 1301, including the second alignable marker element 1310B, taken along line 1398. (See image for details.) Figure 28A As shown, the distal region axis 1305 of the distal region 1304 is substantially perpendicular to the target site 1250, such as the ventricular septum, and therefore perpendicular to... Figure 28D The image of the target area depicted in the image shows a single U-shaped reference shape. Figure 28E and Figure 28F The image shown is taken perpendicular to the target region, wherein the distal region axis 1305 of the distal region 1304 is not substantially perpendicular to the target region 1250, wherein the first alignment marker element 1310A and the second alignment marker element 1310B do not form a reference (such as a single U shape) to indicate misalignment.

[0237] exist Figures 29A to 29C Another exemplary lead 1400 is depicted relative to a target portion 1250 and includes two alignable marker elements 1410, each having a complementary shape. The first alignable marker element 1410A includes a single arcuate portion of a circle (specifically, a semicircle extending approximately 90 degrees), and the second alignable marker element 1410B also includes a single arcuate portion of a circle (specifically, a semicircle extending 180 degrees). Figure 29C The image shows a cross-sectional view of the lead body 1401, including the first alignable marker element 1410A, taken along line 1499, and... Figure 29B The image shows a cross-sectional view of the lead body 1401, including the second alignable marker element 1410B, taken along line 1498. (See image for details.) Figure 29A As shown, the distal region axis 1405 of the distal region 1404 is substantially perpendicular to the target site 1250 (e.g., the ventricular septum), and therefore perpendicular to... Figure 29D The image depicting the target area shows a baseline shape of a single U-shape opening to the upper left. Figure 29E and Figure 29FThe image shown is taken perpendicular to the target region, wherein the distal region axis 1405 of the distal region 1404 is not substantially perpendicular to the target region 1250, wherein the first alignment marker element 1410A and the second alignment marker element 1410B do not form a reference shape (such as a single U shape) to indicate misalignment.

[0238] exist Figures 30A to 30B Another exemplary lead 1500 is depicted, aligned relative to a target portion 1250 and including two alignable marker elements 1510, each having a complementary shape. The first alignable marker element 1510A may be a circular or annular element, and the second alignable marker element 1510B may be a portion of a circle (e.g., a semicircle). In this embodiment, the first alignable marker element 1510A and the second alignable marker element 1510B define different or different dimensions. Specifically, the first alignable marker element 1510A defines a first length 1519, and the second marker element 1510B defines a second length 1512 that is shorter or smaller than the first length 1519. In one embodiment, the first length 1519 may be about 3 mm and the second length 1512 may be about 1 mm. It should be understood that in other embodiments, the first marker element 1510A may have or define a length 1519 that is smaller or smaller than the length 1512 of the second marker element 1510B. Alignable marker elements of varying lengths can help physicians identify the tip or posterior to the tip during the advancement or rotation of the lead body 1501. Additionally, physicians can use left anterior oblique (LAO) images or views (such as...) Figure 30B (As shown) to check the orientation of the catheter tip relative to the diaphragm and the depth of the pacing lead penetration. Figure 30A As shown, LAO images can be taken from direction 1509.

[0239] exist Figure 31The diagram shows a perspective view of two alignment marker elements 1550A, 1550B connected using two extension elements 1511. Although two extension elements 1511 are described herein, it should be understood that one or more extension elements may be used. Extension elements 1511 may provide a fixed interval between the two alignment marker elements 1550A, 1550B, allowing, for example, a physician to use the distance between the two alignment marker elements 1550A, 1550B to determine the depth of penetration into a target area (e.g., the ventricular septum). Extension elements 1511 may comprise the same material as alignment marker elements 1550A, 1550B, or be formed from the same material as the alignment marker elements. In at least one embodiment, the two alignment marker elements 1550A, 1550B and the two extension elements 1511 may be machined from tubing, which facilitates manufacturing and provides a given distance between the alignment marker elements 1550A, 1550B. A fixed spacing or given distance allows the physician to perform small calculations to determine the angle of approach to the septum wall. Additionally, the extension element 1511 can help reinforce the distal region of the lead (in other words, the distal end of this region can be more flexible because the extension element 1511 connects to the alignment marker elements 1550A, 1550B), which can eliminate bending effects that may lead to misalignment during implantation. In at least one embodiment, two alignment marker elements 1550A, 1550B and the extension element 1511 may be provided herein with respect to... Figures 1 to 6 The additive manufacturing system described.

[0240] exist Figures 32A to 32C Another exemplary lead 1600 is depicted relative to a target site 1250 and includes two alignment marker elements 1610, each having a complementary shape. The first alignment marker element 1610A includes four arcuate portions of a circle, and the second alignment marker element 1610B includes three arcuate portions of a circle. Therefore, the alignment marker elements 1610 of the lead 1600 are asymmetrical, which can be used by a physician to determine where the distal end 1603 of the lead 1600 is located when viewed during imaging. Additionally, for example, when implanting a fixation element such as a spiral in the target site 1250, the physician can use the asymmetrical alignment marker elements 1610 to count the number of turns of the distal region 1604 of the lead body 1601 around the axis 1605. Figure 32C The image shows a cross-sectional view of the lead body 1601, including the first alignable marker element 1610A, taken along line 1699, and... Figure 32B The image shows a cross-sectional view of the lead body 1601, including the second alignable marker element 1610B, taken along line 1698. (See image for details.) Figure 32AAs shown, the distal region axis 1605 of the distal region 1604 is substantially perpendicular to the target site 1250, such as the ventricular septum, and therefore perpendicular to... Figure 32D The image of the target site depicted in the image shows a reference shape of a nearly complete circle defining the gap 1615. In one or more embodiments, the alignment marker element 1610 may be configured such that the gap 1615 indicates the deflection direction 1650 of the lead body 1601, for example, via a traction wire. Thus, it can be described that when the alignment marker element 1610 is aligned, the deflection direction 1650 can be shown in the image to help the physician align the distal region 1604 with the target site 1250.

[0241] exist Figures 33A to 33C Another exemplary lead 1700 is depicted, aligned relative to a target site 1250 and comprising two alignment marker elements 1710, each having a complementary shape. Each of the first alignment marker element 1710A and the second alignment marker element 1710B is a circle or ring, each having a different diameter. In this example, the first alignment marker element 1710A defines a smaller diameter compared to the second alignment marker element 1710B. Therefore, the alignment marker elements 1710 of the lead 1700 are asymmetrical, which can be used by a physician to determine the distal end 1703 of the lead 1700 when viewed in imaging. Figure 33C The image shows a cross-sectional view of the lead body 1701, including the first alignable marker element 1710A, taken along line 1799, and... Figure 33B The image shows a cross-sectional view of the lead body 1701, including the second alignable marker element 1710B, taken along line 1798. (See image for details.) Figure 33A As shown, the distal region axis 1705 of the distal region 1604 is substantially perpendicular to the target region 1250, such as the ventricular septum, and therefore perpendicular to... Figure 33E The RAO image taken at 1250° depicting the target area shows a reference shape of two concentric circles. Figure 33DThe image shows a RAO image taken perpendicular to the target area, where the distal region axis 1705 of the distal region 1704 is not substantially perpendicular to the target area 1250. The first alignment marker element 1710A and the second alignment marker element 1710B do not form a reference shape but rather a single circle, thus indicating misalignment. In other words, alignment marker elements 1710A and 1710B can be used for alignment and also to distinguish which direction the distal region 1704 is pointing. If the smaller-diameter first alignment marker element 1710A is closer to the observer (e.g., from where the image is being captured or taken), the alignment marker elements 1710A and 1710B appear concentric. Conversely, if the larger-diameter second alignment marker element 1710B is closer to the observer (e.g., from where the image is being captured or taken), the alignment marker elements 1710A and 1710B will overlap and appear as a single circle.

[0242] The illustrative alignable marker element 1810 may be included as part of a coil or helix, such as Figure 34A An exemplary lead 1800 aligned with a target portion 1250 is shown in Figure 34. In this embodiment, the lead 1800 includes an imageable coil 1811 (e.g., comprising an imageable material) positioned in a distal region 1804. This imageable coil can be described as comprising a plurality of alignment marker elements, each alignment marker element being a single 360-turn of the coil 1811. Two alignment marker elements are labeled in the embodiment of Figure 34: a first alignment marker element 1810A; and a second alignment marker element 1810B. The vertical and parallel views of this embodiment can be used to determine the alignment of the distal region 1804 of the lead body 1801 with the target portion 1250, as relative to... Figures 34B to 34G As shown.

[0243] For example, lead 1800 is in the exemplary image. Figure 34B and Figure 34C The former is aligned with the target portion 1250 (e.g., radially to axis 1805) for shooting, while the latter is perpendicular to the target portion 1250 (e.g., axially to axis 1805) for shooting. Coil 1811 includes... Figure 34B The uniform spacing between the coils and the formation Figure 34C The circular reference shape in the image indicates the orientation of the lead 1800 toward the target. Furthermore, in the illustrative image... Figures 34D to 34G In the middle, the lead wire 1800 is not aligned with the target part 1250, among which... Figure 34D and Figure 34F Take photos at 125° parallel to the target area, and Figure 34E and Figure 34G Shot perpendicular to (e.g., RAO) the target area at 125°. Coil 1811 in Figure 34D The coils in the coils do not have uniform spacing or uniform shape, and Figure 34E A reference shape that does not form a circle (e.g., horizontally overlapping circles are shown) indicates that lead 1800 is misaligned relative to target portion 1250. Similarly, coil 1811 in Figure 34F It appears tilted or angled, and in Figure 34G A reference shape that does not form a circle (e.g., vertically overlapping circles are shown) indicates that lead 1800 is misaligned relative to target portion 1250. In one or more embodiments, a decoder (e.g., a set of examples of the shape of coil 1811 when parallel to target portion 1250 at various angles) can be used to determine the offset angle or angle that is not perpendicular to target portion 1250. Furthermore, in at least one embodiment, coil 1811 may be variable pitch to aid in diagnosing the offset.

[0244] Optionally, this embodiment also includes a tip-alignable marker element 1810C, which is not part of the coil 1811. The orientation of the distal end 1803 of the distal region 1804 can be determined using the tip-alignable marker element 1810C relative to the coil 1811. Additionally, as Figure 34C As shown, when viewed along axis 1805, the tip can be aligned with the marker element 1810C, which will be "stacked" with coil 1811, thereby producing a reference shape of concentric bright rings.

[0245] As described herein, exemplary implantable medical devices, such as leads, catheters, etc., may include more than two alignable marker elements. Figure 35A The diagram depicts an exemplary lead 1900 positioned relative to a target region 1250 with an unintended and less desirable alignment. Lead 1900 includes four alignment marker elements 1910A, 1910B, 1910C, and 1910D. Alignment marker elements 1910A and 1910C are circular, and alignment marker elements 1910B and 1910D are semi-circular, such that when the distal region 1904 of lead 1900 is misaligned, perpendicular to… Figure 35A The image taken of the target area will show two circles, one of which is darker or coarser than the other, such as... Figure 35B As shown. In this example, the darker circle above the brighter circle indicates that the distal end or tip 1903 is pointing upwards. In other words, the distal region 1904 of the lead 1900 is vertically misaligned in the upward direction.

[0246] One or more alignment marker elements can define a direction-indicating shape that, when used for imaging observation, indicates the orientation of a distal region relative to a target site. Figure 36AAn exemplary alignment lead 2000 is depicted, which includes a direction-indicating alignment marker element 2010 positioned near a target portion 1250. As shown, a distal region 2004 is positioned substantially perpendicular to the target portion 1250 (e.g., a distal axis 2005 extending along the distal region 2004 is perpendicular to the plane of the target portion 1250). In this embodiment, the direction-indicating alignment marker element 2010 includes or defines an arrow shape pointing towards the distal end or tip 2003 of the lead body 2001. Figure 36B The image shown is an illustrative image taken perpendicular to the target area at 125°, in which the lead wires are as follows: Figure 36A Positioned and oriented as shown. Figure 36B As shown, the arrow is not visible because the distal region 2004 is substantially aligned (e.g., perpendicular) with the target portion 1250. Figure 36C and Figure 36D The image shows perpendicular to Figure 36A An illustrative image of the target area, in which the leads are positioned and oriented as expected. For example... Figure 36C As shown, the "arrow" image appears to be pointing upwards, which could indicate that the distal area 2004 is not vertically aligned upwards. Figure 36C As shown, the "arrow" image appears to be pointing downwards and to the left, which could indicate that the far region 2004 is vertically misaligned downwards and horizontally misaligned to the left.

[0247] As described herein, multiple alignable marker elements of varying shapes and sizes can be utilized. Figure 37 The diagram depicts a perspective view of an illustrative lead 2100, which includes a plurality of alignable marker elements 2110 having a trapezoidal shape. In other words, the "wedge"-shaped alignable marker elements 2110 define or form a reference shape for annular loops during alignment. When the distal region 2104 is misaligned, the elongated trapezoidal shape of the alignable marker elements 2110 creates or produces a shadow-like projection indicating the offset of the distal region 2104. Additionally, in other views, orientation can be determined based on the non-uniform geometry of the alignable marker elements 2110.

[0248] Several embodiments including multiple alignable marker elements are shown in Figures 38 and 39. Figure 38A The illustration depicts an exemplary alignment lead 2200, which includes a plurality of alignable marker elements 2210A, 2210B positioned near a target portion 1250. In this embodiment, each of the first alignable marker element 2210A and the second alignable marker element 2210B includes or comprises a plurality of marker portions arranged in a circular manner and spaced apart circumferentially and axially. Figure 38B It describes from Figure 38AAnother side view of the distal region 2204 of the leader 2200, rotated 90 degrees about axis 2205. (See also...) Figure 38A As shown, the distal region axis 2205 of the distal region 2204 is substantially perpendicular to the target site 1250, such as the ventricular septum, and therefore perpendicular to... Figure 38C The image taken at target region 1250 shows the reference shape of the dashed circle. Additionally, the "blank" slots can be described as indicating perfect alignment. Figure 38D Another image shown is taken perpendicular to the target region, where the distal region axis 2205 of the distal region 2204 is not substantially perpendicular to the target region 1250. The first alignment marker element 2210A and the second alignment marker element 2210B do not form a reference shape but overlap, thus indicating misalignment. Furthermore, a longer span or distance between the first alignment marker element 2210A and the second alignment marker element 2210B allows for better resolution in axial view alignment.

[0249] exist Figure 39A An exemplary alignment lead 2300 is shown, comprising a plurality of alignable marker elements 2310A, 2310B, 2310C, and 2310D positioned near a target portion 1250. In this embodiment, each alignable marker element 2310A, 2310B, 2310C, and 2310D includes or comprises two semicircles or arcs opposite each other with respect to the lead body 2301. Furthermore, the alignable marker elements 2310A, 2310B, 2310C, and 2310D are evenly spaced from each other along a distal axis 2305. Figure 39A As shown, the distal region axis 2305 of the distal region 2304 is substantially perpendicular to the target portion 1250, such as the ventricular septum, and therefore perpendicular to... Figure 39B The image taken at target region 1250 shows the reference shape of two opposing circular or arc-shaped parts. Figure 39CThe image shown is taken perpendicular to the target region, where the distal region axis 2305 of the distal region 2304 is not substantially perpendicular to the target region 1250. Multiple alignment marker elements 2310A, 2310B, 2310C, and 2310D do not form a reference shape but overlap, thus indicating misalignment. Additionally, a blurred or out-of-focus image can also indicate unintended alignment. When imaged or viewed from the side (e.g., from the side), gaps between alignment marker elements 2310A, 2310B, 2310C, and 2310D indicate acceptable alignment. In one or more embodiments, one or more of the alignment marker elements 2310A, 2310B, 2310C, and 2310D may consist of only a single arc, which can be used to indicate a deflection plane. Furthermore, a longer span or distance between alignment marker elements 2310A, 2310B, 2310C, and 2310D can provide or allow for better resolution of axial view alignment. When imaging or viewing from the side (e.g., from the side), too many bars or stripes can indicate misalignment because the two arcs of each of the alignment marker elements 2310A, 2310B, 2310C, and 2310D are visible rather than overlapping.

[0250] It should be understood that the concept of an alignable marker element described herein can be used in any implantable medical device, such as a lead, catheter, leadless device, etc. Furthermore, in one or more embodiments, one alignable marker element may be located on a delivery catheter, and another alignable element may be located on a device (such as, for example, a lead) delivered by the delivery catheter.

[0251] While this disclosure is not limited thereto, an understanding of various aspects of this disclosure will be gained through discussion of the specific examples and exemplary embodiments provided below. Various modifications to the examples and exemplary embodiments, as well as other embodiments of this disclosure, will become apparent herein.

[0252] Exemplary Examples

[0253] Example 1: An implantable device comprising:

[0254] The main body, which defines the distal region extending along the axis of the distal region; and

[0255] Two alignable marker elements are coupled to the body in the distal region, wherein each of the two alignable marker elements defines a complementary shape that is complementary to the other alignable marker element, such that when the distal region is viewed axially, the two alignable marker elements form a reference shape that indicates an acceptable alignment for positioning the distal region at a target location.

[0256] Example 2: The device according to Example 1, wherein the two alignable marker elements are radiopaque and visible using fluorescence fluoroscopy when located inside the patient's heart.

[0257] Example 3: The device according to Example 1, wherein the two alignable marker elements are echogenic and are visible using ultrasound when located inside the patient's heart.

[0258] Example 4: The device according to any one of Examples 1 to 3, wherein the complementary shape of each of the two alignable marker elements is a circle, and the reference shape is a single circle.

[0259] Example 5: The device according to any one of Examples 1 to 3, wherein the complementary shape of each of the two alignable marker elements is a semicircle, and the reference shape is a single circle.

[0260] Example 6: The device according to any one of Examples 1 to 3, wherein the complementary shape of each of the two alignable marker elements is at least a portion of a circle, and the reference shape is at least a portion of a single circle.

[0261] Example 7: The device according to any one of Examples 1 to 6, wherein each of the two alignable marker elements defines a different size from the other.

[0262] Example 8: The device according to Example 7, wherein a first alignment marker element of the two alignment marker elements defines a first length along the axis of the distal region, and a second alignment marker element of the two alignment marker elements defines a second length along the axis of the distal region, wherein the first length is greater than the second length.

[0263] Example 9: The device according to any one of Examples 7 to 8, wherein each of the two alignable marker elements defines a different diameter from the other.

[0264] Example 10: The device according to any one of Examples 1 to 3, wherein the complementary shape of each of the two alignable marker elements comprises multiple portions of a circle, and the reference shape is a nearly complete portion of a single circle defining a gap, wherein the gap indicates the deflection direction of the body.

[0265] Example 11: The device according to Example 10, wherein the first alignment mark element of the two alignment mark elements includes a first number of portions of the circle, and the second alignment mark element of the two alignment mark elements includes a second number of portions of the circle, wherein the first number is greater than the second number.

[0266] Example 12: The device according to any one of Examples 1 to 11 further includes at least one additional alignment marker element defining another complementary shape complementary to the two alignment marker elements, such that when the distal region is viewed axially, the two alignment marker elements and the at least one additional alignment marker element form the reference shape, which indicates an acceptable alignment for positioning the distal region at the target site.

[0267] Example 13: The device according to Example 12, wherein the at least one additional alignment marker element defines a different size from at least one of the two alignment marker elements, wherein, when the distal region is viewed axially, the two alignment marker elements and the at least one additional alignment marker element form an unaligned reference shape indicating unacceptable alignment of the distal region.

[0268] Example 14: The device according to any one of Examples 1 to 13, wherein the two alignment marker elements define a coil extending along the distal axis, wherein, when the distal region is viewed radially, the minimum length between the two alignment marker elements indicates an acceptable alignment for positioning the distal region at the target location.

[0269] Example 15: The device according to any one of Examples 1 to 13 further includes at least one extension member connected to the two alignable marker elements and extending between the two alignable marker elements.

[0270] Example 16: The device according to any one of Examples 1 to 15, wherein the main body is a delivery conduit or lead.

[0271] Example 17: The device according to any one of Examples 1 to 15, wherein the main body comprises:

[0272] A delivery catheter defining a lumen, wherein a first of two alignable marker elements is coupled to the delivery catheter; and

[0273] A lead wire is positioned within the delivery conduit, wherein the second of the two alignable marker elements is coupled to the lead wire.

[0274] Example 18: The device according to any one of Examples 1 to 17 further includes a fixing element connected to the distal region of the body to connect the body to the target site.

[0275] Example 19: An implantable device comprising:

[0276] The main body, which defines the distal region extending along the axis of the distal region; and

[0277] An alignable marker element is attached to the body in the distal region to define a direction-indicating shape that, when the distal region is viewed axially, indicates the direction in which the distal region is away from the target.

[0278] Example 20: An additive manufacturing system comprising:

[0279] One or more heating cylinders, each heating cylinder extending from a proximal side to a distal side and including a substrate inlet port located on the proximal side and a substrate outlet port located on the distal side, each heating cylinder defining an internal volume and a substrate channel extending from the proximal side through the internal volume to the distal side, each heating cylinder defining a first filament port in fluid communication with the internal volume to receive a first filament;

[0280] A heating element thermally connected to each of the one or more heating cylinders to heat the internal volume;

[0281] A filament processing system, the filament processing system including one or more motors for feeding at least the first filament into the internal volume through the first filament port;

[0282] Substrate processing system, the substrate processing system comprising:

[0283] A headframe, comprising a distal clamp for securing a distal portion of an elongated substrate, wherein the substrate is positioned to pass through a substrate channel when secured by the headframe; and

[0284] One or more motors that cause one or both of the substrate fixed by the head frame and the heating cylinder to translate or rotate relative to each other;

[0285] An intermediate component system positioned near the heated barrel to position two alignable marker elements, each defining a complementary shape to the other alignable marker element; and

[0286] A controller operatively coupled to the heating element, one or more motors of the filament processing system, and one or more motors of the substrate processing system, the controller...

[0287] The device is configured as follows:

[0288] The one or more motors of the filament processing system are controlled to selectively control the feeding of the first filament into the internal volume;

[0289] Activate the heating element to melt any portion of the first filament within the internal volume;

[0290] Controlling one or more motors of the substrate processing system to move the substrate and one or both of the one or more heating cylinders relative to each other in at least the longitudinal direction to form a first elongated conduit sheath around the substrate; and

[0291] The intermediate component system is controlled to deposit the two alignable marker elements onto the first elongated conduit sheath within the distal region element extending along the distal region axis, such that when the distal region is viewed axially, the two alignable marker elements form a reference shape that indicates an acceptable alignment of the distal region for positioning at the target site.

[0292] Example 21: The system according to Example 20, wherein the controller is further configured to:

[0293] The one or more motors of the filament processing system are controlled to selectively control the feeding of the second filament into the internal volume;

[0294] Activate the heating element to melt any portion of the second filament within the internal volume;

[0295] as well as

[0296] One or more motors of the substrate processing system are controlled to move the substrate and one or both of the one or more heating cylinders relative to each other in at least the longitudinal direction to form a second elongated conduit sheath around the first elongated conduit sheath and the two alignable marker elements.

[0297] Example 22: The system according to any one of Examples 20 to 21, wherein the two alignable marker elements are radiopaque and visible using fluorescence fluoroscopy when located inside the patient's heart.

[0298] Example 23: The system according to any one of Examples 20 to 21, wherein the two alignable marker elements are echogenic and are visible using ultrasound when located inside the patient's heart.

[0299] Example 24: The system according to any one of Examples 20 to 23, wherein the complementary shape of each of the two alignable marker elements is at least a portion of a circle, and the reference shape is a single circle.

[0300] Example 25: A method for navigating an implantable device in a patient's heart, the method comprising:

[0301] Provides an implantable device, the implantable device comprising:

[0302] The main body, which defines the distal region extending along the axis of the distal region; and

[0303] Two alignable marker elements are coupled to the body in the distal region, wherein each of the two alignable marker elements defines a complementary shape that is complementary to the other alignable marker element, such that the two alignable marker elements form a reference shape when the distal region is viewed axially.

[0304] Navigate the distant area near the target location;

[0305] Generate an image perpendicular to the target area that can be aligned with the marker element; and

[0306] The alignable marker elements are determined to form a reference shape in the generated image that indicates an acceptable alignment of the distal region.

[0307] Example 26: The method according to Example 25 further includes:

[0308] If the alignable marker element does not form the reference shape in the generated image, adjust one or both of the orientation and position of the distal region near the target site.

[0309] Generate another image perpendicular to the target area that can be aligned with the marker element; and

[0310] Determine the reference shape in which the alignment marker element forms an acceptable alignment of the distal region in another generated image.

[0311] Example 27: The method according to any one of Examples 25 to 26, wherein the image taken perpendicular to the target site of the alignable marker element is a left anterior oblique image of the patient's heart.

[0312] Example 28: The method according to any one of Examples 25 to 27, wherein the two alignable marker elements are radiopaque and visible using fluorescence fluoroscopy when located inside the patient's heart, wherein the image taken perpendicular to the target site of the alignable marker elements is a fluorescence fluoroscopic image.

[0313] Example 29: The method according to any one of Examples 25 to 27, wherein the two alignable marker elements are echogenic and are visible using ultrasound when located within the patient's heart, wherein the image taken perpendicular to the target site of the alignable marker elements is an ultrasound image.

[0314] Example 30: The method according to any one of Examples 25 to 29, wherein the complementary shape of each of the two alignable marker elements is at least a portion of a circle, and the reference shape is a single circle.

[0315] Example 31: The method according to any one of Examples 25 to 30, wherein the target site is an intracardiac septum, wherein navigating the distal region to the vicinity of the target site includes navigating the distal region to the vicinity of the intracardiac septum in the right ventricle.

[0316] Example 32: A method for forming a lead, the method comprising:

[0317] A lead body is provided extending from a proximal region to a distal region defining a lumen, wherein a conductor is positioned within the lumen;

[0318] Define the opening through the lead body;

[0319] The conductor is extended through the lumen to the outside of the lead body;

[0320] Position the C-shaped electrode near the conductor outside the lead body;

[0321] Electrically connect the C-shaped electrode to the conductor; and

[0322] The C-shaped electrode is mechanically connected to the lead body.

[0323] Example 33: According to the method of Example 32, the lead body includes an extension region and an electrode connection region, wherein the electrode connection region is where the C-shaped electrode is connected to the lead body, wherein the extension region defines a first outer diameter and the electrode connection region defines a second outer diameter smaller than the first outer diameter.

[0324] Example 34: The method according to Example 33, wherein the C-shaped electrode defines an inner surface, an outer surface, and a thickness between the inner surface and the outer surface, wherein the thickness of the C-shaped electrode is less than or equal to the difference between the first outer diameter and the second outer diameter.

[0325] Example 35: The method according to any one of Examples 32 to 34, wherein providing the lead body includes forming the lead body around the conductor using additive manufacturing.

[0326] Example 36: The method according to any one of Examples 32 to 35, wherein electrically connecting the C-shaped electrode to the conductor includes laser welding the C-shaped electrode to the conductor.

[0327] Example 37: The method according to Example 36, wherein the C-shaped electrode defines an inner surface and an outer surface, wherein the laser welding is applied to the outer surface of the C-shaped electrode to electrically connect the inner surface to the conductor.

[0328] Example 38: The method according to any one of Examples 32 to 37, wherein the C-shaped electrode extends circumferentially from a first end to a second end and defines a gap between the first end and the second end, wherein mechanically attaching the C-shaped electrode to the lead body includes deforming the C-shaped electrode toward the conductor to close the gap, such that the first end contacts the second end.

[0329] Example 39: The method according to any one of Examples 32 to 38, wherein the method further comprises: after extending the conductor through the lumen to the outside of the lead body, closing the opening in the lead body.

[0330] Example 40: The method according to Example 39, wherein closing the opening in the lead body includes thermally bonding the lead body.

[0331] Example 41: The method according to any one of Examples 32 to 40, wherein the lead body is less than or equal to 3Fr.

[0332] Example 42: The method according to any one of Examples 32 to 41, wherein the lead body is less than or equal to 4Fr.

[0333] Example 43: A lead wire comprising:

[0334] A lead body extending from a proximal end to a distal end and defining an S-shaped region near the distal end, a first vertex region within the S-shaped region, and a second vertex region within the S-shaped region;

[0335] A first electrode, the first electrode being positioned at the first vertex region; and

[0336] The second electrode is located at the second vertex region.

[0337] Example 44: The lead wire according to Example 43, wherein each of the first electrode and the second electrode is a coil electrode.

[0338] Example 45: A lead wire according to any one of Examples 43 to 44, wherein the lead wire body is less than or equal to 3Fr.

[0339] Example 46: A lead according to any one of Examples 43 to 44, wherein the lead body is less than or equal to 4Fr.

[0340] Example 47: A lead according to any one of Examples 43 to 46, wherein the lead body further defines a straight portion positioned near the S-shaped region, wherein the straight portion extends along an axis and defines the axis when not deflected, wherein at least one of the first vertex region and the second vertex region is positioned away from the axis at a vertical radial distance greater than the remaining portion of the lead body when not deflected.

[0341] Example 48: According to the lead wire described in Example 47, when not deflected, both the first vertex region and the second vertex region are located away from the axis at a radial distance greater than the rest of the lead wire body.

[0342] Example 49: A lead wire according to any one of Examples 43 to 48, wherein the first vertex region is located on the side of the axis opposite to the second vertex region.

[0343] Example 50: A lead wire according to any one of Examples 43 to 49, wherein the S-shaped region defines a first curved portion and a second curved portion away from the first curved portion, wherein the first curved portion defines a first radius and the second curved portion defines a second radius, wherein the second radius is smaller than the first radius when the lead wire is not deflected.

[0344] Example 51: The lead wire according to Example 50, wherein the lead wire body defines an end bend portion away from the S-shaped region.

[0345] Example 52: The lead wire according to Example 51, wherein the end bend defines a third radius, which is smaller than the second radius when the lead wire is not deflected.

[0346] Therefore, various embodiments described herein are disclosed. It should be understood that the aspects disclosed herein can be combined in combinations different from those specifically given in the specification and drawings. It should also be understood that, depending on the example, certain actions or events of any of the processes or methods described herein may be performed in a different order, or may be completely added, combined, or omitted (e.g., performing these techniques may not require all the described actions or events). Furthermore, although for clarity some aspects of this disclosure are described as being performed by a single module or unit, it should be understood that the techniques of this disclosure can be performed by combinations of units or modules associated with, for example, a medical device.

[0347] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functionality may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include non-transitory computer-readable media, which correspond to tangible media such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and is accessible by a computer).

[0348] The instructions can be executed by one or more processors, such as one or more digital signal processors (DSPs), general-purpose microprocessors, application-specific integrated circuits (ASICs), field-programmable arrays (FPGAs), or other equivalent integrated or discrete logic circuit systems. Therefore, the term "processor" as used herein can refer to any of the foregoing structures or any other physical structures suitable for implementing the described techniques. Furthermore, this technique can be fully implemented in one or more circuit or logic elements.

[0349] All references and publications cited herein are expressly incorporated in their entirety by way of citation for all purposes, unless in any way directly contradict this disclosure.

[0350] Unless otherwise specified, all numerical values ​​used in the specification and claims to indicate characteristic dimensions, quantities, and physical properties are to be understood as being modified by the terms “precisely” or “about”. Therefore, unless otherwise indicated, the numerical parameters set forth in the foregoing specification and appended claims are approximate values ​​that may vary within the typical range of experimental error, depending on the desired properties sought by a person skilled in the art using the teachings disclosed herein.

[0351] As used herein, the term "configured as" may be used interchangeably with the terms "adapted as" or "structured as" unless otherwise clearly stated in this disclosure.

[0352] The singular forms “a”, “an” and “the” cover embodiments with plural indicators unless the context clearly indicates otherwise.

[0353] As used in this article, "have," "having," "include," "including," "comprise," and "comprising" are used in their open-ended sense and generally mean "including but not limited to." It should be understood that "basically composed of," "composed of," etc., are categorized under "included," etc.

[0354] References to "an embodiment," "an embodiment," "certain embodiments," or "some embodiments," etc., mean that a particular feature, configuration, composition, or characteristic described in connection with that embodiment is included in at least one embodiment of this disclosure. Therefore, the appearance of such references throughout the document does not necessarily refer to the same embodiment of this disclosure. Furthermore, particular features, configurations, compositions, or characteristics may be combined in any suitable manner in one or more embodiments.

[0355] The terms "preferred" and "preferred" refer to embodiments of this disclosure that may provide certain benefits in certain circumstances. However, other embodiments may also be preferred in the same or other circumstances. Furthermore, the description of one or more preferred embodiments does not imply that other embodiments are useless, nor is it intended to exclude other embodiments from the scope of this disclosure.

Claims

1. An implantable device (1200), the implantable device comprising: Body (1201), the body defining a distal region (1204) extending along a distal region axis. and Two alignable marker elements (1210) are coupled to the body in the distal region, wherein each of the two alignable marker elements defines a complementary shape that is complementary to the other alignable marker element, such that when the distal region is viewed axially, the two alignable marker elements form a reference shape that indicates an acceptable alignment of the distal region for positioning at a target location.

2. The device according to claim 1, wherein, The two alignable marker elements (1210) are at least one of the following: radiopaque and visible by fluorescence fluoroscopy when located inside the patient's heart, or echogenic and visible by ultrasound when located inside the patient's heart.

3. The device according to claim 1 or 2, wherein, The complementary shape of each of the two alignable marker elements is at least a portion of a circle, and the reference shape is at least a portion of a single circle.

4. The device according to claim 3, wherein, The complementary shape of each of the two alignable marker elements is a circle or a semicircle, and the reference shape is a single circle.

5. The device according to claim 1 or 2, wherein, The complementary shape of each of the two alignable marker elements (1610) comprises multiple portions of a circle, and the reference shape is a nearly complete portion of a single circle defining a gap (1615), wherein the gap indicates the deflection direction of the body.

6. The device according to claim 1 or 2, wherein, Each of the two alignable marker elements defines a different size from the others.

7. The device according to claim 6, wherein, The first alignment marker element of the two alignment marker elements defines a first length along the axis of the distal region, and the second alignment marker element of the two alignment marker elements defines a second length along the axis of the distal region, wherein the first length is greater than the second length.

8. The device of claim 1 or 2, further comprising at least one additional alignment marker element defining another complementary shape complementary to the two alignment marker elements, such that when the distal region is viewed axially, the two alignment marker elements and the at least one additional alignment marker element form the reference shape, the reference shape indicating an acceptable alignment for positioning the distal region at the target site.

9. The device according to claim 1 or 2, wherein, When the distal region is viewed axially, the two alignable marker elements form an unaligned reference shape indicating unacceptable alignment of the distal region, and when the distal region is viewed radially, the minimum length between the two alignable marker elements indicates acceptable alignment of the distal region for positioning at the target site.

10. The device according to claim 1 or 2, further comprising at least one extension member coupled to the two alignable marker elements and extending between the two alignable marker elements.

11. The device according to claim 1 or 2, further comprising a fixing element coupled to the distal region of the body to attach the body to the target site.

12. An additive manufacturing system (100), the additive manufacturing system comprising: One or more heating cylinders (102), each heating cylinder extending from a proximal side (410) to a distal side (412) and including a substrate inlet port (414) located at the proximal side and a substrate outlet port (416) located at the distal side, each heating cylinder defining an internal volume and a substrate channel (206) extending from the proximal side through the internal volume to the distal side, each heating cylinder defining a first filament port (216) in fluid communication with the internal volume to receive a first filament (114). A heating element (202) is thermally connected to each of the one or more heating cylinders to heat the internal volume; A filament processing system (106) includes one or more motors for feeding at least the first filament into the internal volume through the first filament port; Substrate processing system (108), the substrate processing system comprising: Headframe (120), the headframe including a distal clamp for securing a distal portion of an elongated substrate, wherein the substrate is positioned to pass through a substrate channel when secured by the headframe; and One or more motors that cause one or both of the substrate and the heating cylinder, which are fixed by the head frame, to translate or rotate relative to each other; An intermediate component system, positioned near the heated barrel to position two alignable marker elements (1210), wherein each of the two alignable marker elements defines a complementary shape complementary to the other alignable marker element; and A controller (110), operatively connectable to the heating element, one or more motors of the filament processing system, and one or more motors of the substrate processing system, is configured to: Control the one or more motors of the filament processing system to control the feeding of the first filament into the internal volume; Activate the heating element to melt any portion of the first filament in the internal volume; Control one or more motors of the substrate processing system to move the substrate and one or both of the one or more heated barrels relative to each other in at least the longitudinal direction to form a first elongated conduit sheath (500) around the substrate; and The intermediate component system is controlled to deposit the two alignable marker elements onto the first elongated conduit sheath within a distal region element extending along the distal region axis, such that when the distal region is viewed axially, the two alignable marker elements form a reference shape that indicates an acceptable alignment of the distal region for positioning at a target site.

13. The system according to claim 12, wherein, The controller is further configured to: Control the one or more motors of the filament processing system to control the feeding of the second filament into the internal volume; Activate the heating element to melt any portion of the second filament within the internal volume; as well as One or more motors of the substrate processing system are controlled to move the substrate and one or both of the one or more heating cylinders relative to each other in at least the longitudinal direction to form a second elongated conduit sheath around the first elongated conduit sheath and the two alignable marker elements.

14. The system according to claim 12 or 13, wherein, The two alignable marker elements are at least one of the following: radiopaque and visible by fluorescence fluoroscopy when located inside the patient's heart, or echogenic and visible by ultrasound when located inside the patient's heart.

15. The system according to any one of claims 12 or 13, wherein, The complementary shape of each of the two alignable marker elements is at least a portion of a circle, and the reference shape is at least a portion of a single circle.

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