Systems and methods for manufacturing 3D printed medical devices

Abstract

This invention provides a system and method for manufacturing an elongated medical device comprising various surface features. The system includes a heating cylinder, a heating element, a filament processing system, a substrate processing system, a controller, and one or more additional components adapted to form the surface features on the medical device. The heating element melts the filament material within the heating cylinder to form a sheath of the medical device, and the one or more additional components engage the outer surface of the sheath to create the surface features.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 059,867, filed on July 31, 2020, which is incorporated herein by reference in its entirety.

[0002] This disclosure relates in general to medical devices, and more specifically to additive manufacturing or 3D printing of medical devices such as catheters and implantable stimulation leads.

[0003] Medical catheters and leads are commonly used to access blood vessels and other locations within the body to perform various functions. For example, delivery catheters can be used to deliver medical devices such as implantable medical leads. Many such medical devices are designed to navigate through 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 curves in the vascular system, but 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 characteristics 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. Summary of the Invention

[0004] The technology disclosed herein relates generally to additive manufacturing of medical devices, such as catheters and leads, which allows for further customization of these devices. For example, the systems and techniques described herein allow for rapid integration of features, iterative design, and the design of new geometries and features in a more specific manner. Specifically, the shape and / or size of the medical device or features disposed thereon can be readily manufactured according to operator specifications. Therefore, the unique characteristics of the patient's vascular system can be considered when designing and manufacturing the medical device.

[0005] 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

[0006] Figure 1 This is a conceptual diagram of an exemplary additive manufacturing system based on this disclosure.

[0007] Figure 2 It is used for, for example Figure 1 A conceptual diagram of an exemplary additive manufacturing equipment for an additive manufacturing system.

[0008] Figure 3 Is with, for example Figure 1A conceptual diagram of an exemplary heated barrel used in additive manufacturing systems.

[0009] Figure 4 It can be used for example Figure 1 A conceptual diagram of an exemplary exit die in a heated barrel of an additive manufacturing system.

[0010] 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.

[0011] Figure 6 It can be used before removing the substrate. Figure 1 A conceptual diagram of an exemplary conduit manufactured using an additive manufacturing system.

[0012] Figure 7 Is with, for example Figure 1 An illustrative image of a gate used in an additive manufacturing system.

[0013] Figure 8 Is with, for example Figure 1 An image of an exemplary cutting tool used in additive manufacturing systems.

[0014] Figure 9 Is with, for example Figure 1 An illustrative image of an additional guide sheath used in conjunction with an additive manufacturing system.

[0015] Figure 10 Is with, for example Figure 1 A conceptual diagram of an exemplary rolling wheel used in an additive manufacturing system.

[0016] Figure 11 It is usable Figure 1 Images of exemplary catheters, including circumferential protrusions, manufactured using additive manufacturing systems.

[0017] Figure 12 Is with, for example Figure 1 An illustrative image of a heated barrel used in additive manufacturing systems.

[0018] Figure 13 It is shown that, for example, Figure 1 A flowchart of an example of a method used in conjunction with an additive manufacturing system.

[0019] Figure 14 It is shown that, for example, Figure 1 A flowchart of another example of a method used in conjunction with an additive manufacturing system.

[0020] Figure 15 It is shown that, for example, Figure 1A flowchart of another example of a method used in conjunction with an additive manufacturing system. Detailed Implementation

[0021] This disclosure provides an additive manufacturing system and method for medical devices, such as catheters and leads, which allows for the customization of medical devices. Additive manufacturing can also be described as three-dimensional (3D) printing. Compared to existing technologies for producing catheters, catheter components, or implantable devices, a wider range of hardness levels can be achieved by using additive manufacturing processes. Furthermore, additive manufacturing processes allow for a variety of tooling operations and processes to design and develop specific medical device features (which may be difficult to manufacture by other means). For example, the system can operate similarly to a polymer printer and polymer lathe to produce and refine any particular medical device. Thus, new designs and new dimensions can be produced efficiently.

[0022] Specifically, designing the shape and size of a medical device can facilitate customization for a specific application. For example, a particular design / shape may be more patient-specific than that of another patient. Therefore, externally added three-dimensional surface protrusions (such as threads, splines, small blocks, or the like) can improve the performance of the medical device by modifying the friction of the interface surfaces between the body of the medical device and the patient's anatomy. For example, in one or more embodiments, surface features can provide anchoring mechanisms for screwing or threading the medical device into a ring-shaped / cylindrical anatomical feature, or produce preferred performance characteristics (e.g., bending, straightening, torsion, etc.). In other words, the medical device can be easily modified to define other features using the tooling and methods described herein.

[0023] 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.

[0024] 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.

[0025] As used herein, the term "connection" or "link" refers 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.

[0026] As used herein, any terms relating to position or orientation, such as “proximal,” “distal,” “end,” “outer,” “inner,” etc., refer to relative positions and do not limit the absolute orientation of the implementation, unless the context otherwise clearly specifies.

[0027] 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.

[0028] 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.

[0029] 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.

[0030] Other components of system 100 may be illustrated as described in U.S. Patent Application 62 / 927,092 entitled “ADDITIVE MANUFACTUING FOR MEDICALDEVICES,” which is incorporated herein by reference. For example, as shown in the illustrated 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 provided by filament processing system 106 to melt the filament material in heating cylinder 102. Optional wire 115 may not be melted by heating cylinder 102. Substrate processing system 108 can be operatively coupled to heating cylinder 102. Substrate processing system 108 provides substrate 116 extending through heating cylinder. Molten filament material located in heating cylinder 102 can be applied to substrate 116. Substrate 116 or heating cylinder 102 can be translated or rotated relative to each other via substrate processing system 108. Substrate processing system 108 can be used to move substrate 116 or heating cylinder 102 relative to each other to cover substrate 116 with molten filament material, thereby forming sheath 118. Optional wire 115 can be incorporated into sheath 118 (e.g., molded into sheath, laminated within sheath, etc.).

[0031] 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.

[0032] 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.

[0033] 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.

[0034] 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 or 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.

[0035] 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 connected 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.

[0036] When substrate 116 is secured by one or both of holders 120, 122, the substrate is typically positioned through a substrate channel defined by heated cylinder 102. One or both of holders 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 longitudinal axis 126 in a clockwise or counterclockwise direction. A translation motor is operatively coupled between holders 120, 122 and platform 124. In some embodiments, the translation motor may be used to translate holders 120, 122 in a longitudinal direction along longitudinal axis 126. In some embodiments, the translation motor may also be used to translate holders 120, 122 in a transverse direction other than longitudinal axis 126. The transverse direction may be oriented substantially orthogonal to or perpendicular to longitudinal axis 126.

[0037] 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.

[0038] 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 a substrate channel in 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.

[0039] 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.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] 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.

[0044] 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 of the filaments 114.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] 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.

[0056] 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.

[0057] 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.

[0058] 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.

[0059] 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.

[0060] 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.

[0061] 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.

[0062] 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.

[0063] 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.

[0064] 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.

[0065] 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.

[0066] 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.

[0067] 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.

[0068] 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.

[0069] 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.

[0070] 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.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] The second guide sheath 234 may define a lumen in fluid communication with the internal volume 204. A second filament 214 extends through the second guide sheath 234 from the second processing subassembly 232 to the radiator 236, through the radiator 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 22 in the second processing subassembly 232. In some embodiments, the second guide sheath 234 may extend at least partially into the radiator 236.

[0075] 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.

[0076] 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).

[0077] 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.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] 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.

[0082] 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.

[0083] 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.

[0084] 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.

[0085] 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.

[0086] Figure 4 This shows a heating cylinder 102 ( Figure 1 An end view of an example inlet or outlet die 700. The die 700 may define a substrate inlet or outlet port 702. The port 702 may define a main region 704 and one, two, three, four or more cutouts 706 or cutout regions. In the illustrated embodiment, the port 702 defines four cutouts 706.

[0087] 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.

[0088] 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 lines, 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.

[0089] 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.

[0090] 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.

[0091] Figure 6 An 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.

[0092] The substrate 116 may be covered with a gasket 602, such as a PTFE layer. The gasket 602 may be placed above the lubricating coating. The gasket 602 may extend around the circumference of the substrate 116.

[0093] The gasket 602 may be covered with a braid 604, such as a stainless steel braided layer. The braid 604 may be placed on top of the gasket 602. The braid 604 may extend around the circumference of the gasket 602. The braid 604 may be porous.

[0094] The sheath 118 can be applied to the woven fabric 604. When the sheath 118 is formed, the padding 602 can be adhered to the sheath 118 through the holes in the woven fabric 604.

[0095] In the illustrated embodiment, the conduit 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 of 72D, the third segment 610 may have a Shore hardness of 35D, and the second segment 608 may have a Shore hardness that gradually changes from 72D to 35D along its length.

[0096] The sheath 118 generated by system 100 can be changed and modified in various ways to provide specific features of the sheath 118. For example, such as Figure 1 As shown, system 100 may include an additional component 101 operable to further process sheath 118 to include various features. In one or more embodiments, the additional component 101 may be directly coupled to the heating cylinder 102. In other embodiments, the additional component 101 may be spaced apart from the heating cylinder 102 along a longitudinal axis 126. Regardless of whether the additional component 101 is directly attached to or spaced apart from the heating cylinder 102, the additional component 101 may be positioned distally (e.g., rearward) of the heating cylinder 102 such that the additional component 101 can alter or modify the sheath 118 after it has been formed by the heating cylinder 102.

[0097] In one or more embodiments, system 100 may be adapted to selectively adjust the substrate outlet to modify its size and / or shape. In other words, the substrate outlet may be blocked or shielded to further refine the shape of the material defining the sheath 118. Specifically, as Figure 7 As shown, system 100 may include a gate 510 defining an opening 512 that coincides with and is longitudinally spaced from the substrate outlet. Gate 510 may include a body portion 514 and one or more fins 516 movably coupled to the body portion 514 such that the one or more fins 516 are adapted to move relative to the substrate outlet to modify the size and / or shape of the substrate outlet. For example, the one or more fins 516 may modify the opening such that the profile of the sheath 118 extending through the substrate outlet can be altered. Gate 510, as described herein, may operate analogously to a camera shutter or aperture.

[0098] The gate 510 can be configured to modify the sheath 118 in various different ways. For example, the gate 510 can expand and contract to change the thickness or cross-sectional diameter of the sheath 118. Additionally, as... Figure 7As shown, one or more fins 516 of the gate 510 can alter or modify the cut 706 of the outlet die 700, such that the size and / or shape of the cut 706 can be modified (and thus the characteristics of the resulting protrusion on the sheath 118 can be altered). For example, one or more fins 516 can be moved to change the height of the cut 706 or to completely remove the cut 706. In other words, the gate 510 can be configured to switch back and forth between producing a sheath with protrusions (e.g., when the fins do not block all or part of the cut) and a sheath without protrusions (e.g., when the fins completely block the cut). Additionally, the gate 510 can be configured to reduce the overall diameter of the outlet, such that the resulting diameter of the sheath can be modified. Thus, the gate 510 can be used to define varying output geometries (e.g., tapered portions) on the sheath (e.g., near the end of the sheath).

[0099] Each of the one or more fins 516 may extend between a first end region 517 movably coupled to a body portion 514 (e.g., pivotable via a pin) and a second end region 518 adapted to move relative to a substrate outlet. In other words, the second end region 518 of the fin 516 may be adapted to cover or block (e.g., at least partially) the substrate outlet (e.g., to define a feature portion of the sheath). Furthermore, the gate 510 may include one or more links 520, each link 520 corresponding to a fin in one or more fins 516. Each link 520 may extend between a first end region movably coupled to a body portion and a second end region movably coupled to a corresponding fin 516 (e.g., pivotable via a pin). In one or more embodiments, the body portion 514 may define one or more slots 522, with each link 520 (e.g., the first end region) movably coupled within one or more slots.

[0100] Furthermore, the controller can be adapted to alter these characteristics along the length of the sheath by changing the position of one or more fins 516. In other words, the gate 510 can be controllable to selectively position one or more fins 516 relative to the substrate outlet, thereby affecting the shape and / or size of the sheath. Therefore, when manufacturing the sheath, the user can specifically modify the features of the sheath by controlling the gate 510. In other words, the gate 510 can be able to open and close the features at specific times and locations during the printing of the sheath. Additionally, one or more fins 516 of the gate 510 can change the shape of the opening to provide radial taper or to embed the shape within the sheath.

[0101] Gate 510 can be positioned relative to the heating cylinder (e.g., the substrate outlet port) in any suitable manner. For example, in one or more embodiments, gate 510 may be located distal to the substrate outlet port. In other embodiments, gate 510 may be located proximal to the substrate outlet port (e.g., between the outlet die and the inlet die). Additionally, in one or more embodiments, gate 510 may be directly attached to the heating cylinder (e.g., attached to the outlet die). In other embodiments, gate 510 may be spaced apart from the heating cylinder. In such embodiments, gate 510 may move with the heating cylinder to perform post-processing of the sheath after sheath formation.

[0102] like Figure 8 As shown, system 100 may include one or more cutting tools 530 to engage a sheath 118 and define features therein. For example, the cutting tool 530 may be used as a surface modification tool to slice and / or elevate the surface of the sheath 118 into various shapes (e.g., similar to a lathe or CNC-type tool that can be invoked and moved as needed). In one or more embodiments, one or more cutting tools 530 may be heated to melt / soften and form a portion of the sheath 118 that engages with the cutting tool. Each of the one or more cutting tools 530 may include a cutting edge 532 oriented toward a longitudinal axis 126 and may be configured to selectively engage the sheath 118. In other words, the cutting edge 532 of the cutting tool 530 may interact with the sheath 530 to remove material therefrom to define features on the surface of the sheath 118. For example, features defined in the surface of the sheath 118 may be used to create structures that can interact with specific geometries and anatomical features of blood vessels, or to provide space / channels for placing various components therein.

[0103] The cutting edge 532 of one or more cutting tools 530 may be positioned between the edge of the substrate outlet and the longitudinal axis to position the cutting edge 532 close to the outer surface of the sheath 118 (e.g., formed through the substrate outlet). For example, the cutting edge 532 of one or more cutting tools 530 may be configured to engage the sheath 118 from a shallow cut that can be used as a surface finish, a deep cut that extends the entire depth / thickness of the sheath 118, or anywhere in between.

[0104] Each of the one or more cutting tools 530 may extend along a cutting axis 535 between a base edge 534 and a cutting edge 532. In one or more embodiments, the cutting axis 535 may be positioned relative to the longitudinal axis 126 at a downward angle between about 0 degrees and 180 degrees. Preferably, the cutting axis 535 may be positioned relative to the longitudinal axis at a downward angle less than or equal to about 90 degrees, less than or equal to 75 degrees, less than or equal to 60 degrees, less than or equal to 45 degrees, etc., and / or greater than or equal to 0 degrees, greater than or equal to 15 degrees, greater than or equal to 30 degrees, greater than or equal to 40 degrees, etc.

[0105] Furthermore, in one or more embodiments, one or more cutting tools 530 may be movably coupled to the heated barrel (e.g., at the base edge) or to any other structure distal to the heated barrel. Thus, one or more cutting tools 530 may be movable between an engaged position and a spaced-out position (e.g., pivoting between these positions). When in the engaged position, the cutting tool 530 (e.g., the cutting edge) may contact the sheath 118 (e.g., to cut and define a portion of the sheath), and when in the spaced-out position, it does not contact the sheath 118. In one or more embodiments, movement may occur by pivoting the cutting tool 530 or by laterally moving the cutting tool 530 to an appropriate position. Furthermore, in one or more embodiments, one or more cutting tools 530 may be configured to move radially along the sheath 118 to a specific location.

[0106] One or more cutting tools 530 may include any number of suitable cutting tools. For example, one or more cutting tools 530 may include one, two, three, or four or more cutting tools. In one or more embodiments, the multiple cutting tools 530 may be configured to move independently of each other. Note that the controller may be configured to control various movements of one or more cutting tools 530.

[0107] One or more cutting tools 530 may be positioned relative to the heating barrel (e.g., the substrate exit port) in any suitable manner. For example, in one or more embodiments, one or more cutting tools 530 may be located distal to the substrate exit port. In other embodiments, one or more cutting tools 530 may be located proximal to the substrate exit port (e.g., between the exit die and the inlet die). Additionally, in one or more embodiments, one or more cutting tools 530 may be directly attached to the heating barrel (e.g., attached to the exit die). In other embodiments, one or more cutting tools 530 may be spaced apart from the heating barrel. In such embodiments, one or more cutting tools 530 may move with the heating barrel to perform post-processing of the sheath after sheath formation.

[0108] like Figure 9 As shown, system 100 may also include an additional guide sheath 540 configured to modify or alter the sheath 118 using additional filament material 542. For example, the additional guide sheath 540 may be positioned distal to the heated barrel 102 (e.g., the exit die) and may define an additional filament lumen 544 configured to receive the additional filament 542. In one or more embodiments, the additional filament 542 may be fed through the additional guide sheath 540 using a filament handling system as described herein.

[0109] The additional guide sheath 540 can be configured to move along any portion of the sheath 118 to selectively deposit additional filament material 542 onto the sheath 118. For example, the additional guide sheath 540 can be configured to move relative to the sheath 118 (e.g., longitudinally or radially) using a controller. By depositing the additional filament material 542 onto the sheath 118, various features can be formed to modify the properties of the sheath 118. For example, lobes or protrusions can be formed on the surface of the sheath.

[0110] The additional filament 542 may comprise the same material as the first filament 114. In other words, the feature defined by the additional filament 542 may be the same material as the material forming the sheath 118. In other embodiments, the additional filament 542 may comprise a different material than the first filament 114. In other words, the feature defined by the additional filament 542 may be a different material than the material forming the sheath 118 (e.g., including different properties).

[0111] The additional guide sheath 540 can be positioned relative to the heated barrel (e.g., the substrate exit port) in any suitable manner. For example, in one or more embodiments, the additional guide sheath 540 may be located distal to the substrate exit port. In other embodiments, the additional guide sheath 540 may be located proximal to the substrate exit port (e.g., between the exit die and the inlet die). Additionally, in one or more embodiments, the additional guide sheath 540 may be directly attached to the heated barrel (e.g., attached to the exit die). In other embodiments, the additional guide sheath 540 may be spaced apart from the heated barrel. In such embodiments, the additional guide sheath 540 may move with the heated barrel to perform post-processing of the sheath after sheath formation.

[0112] In one or more embodiments, system 100 may include, for example: Figure 10One or more rollers 550 are shown. These rollers 550 may be longitudinally spaced from the substrate outlet and engage the outer surface of the sheath 118. For example, the rollers 550 may be used as surface modification tools to form a surface of the sheath 118 that remains deformable (e.g., flexible) after melting. Each of the one or more rollers 550 may be configured to rotate about an axis 551 perpendicular to the longitudinal axis 126. Furthermore, the axis of rotation 551 of each of the plurality of rollers 550 may be different and positioned along a circle concentric with the substrate outlet. In other words, each roller 550 may be oriented in a different plane and spaced around the sheath such that each roller is orthogonal to the surface of the sheath 118 (e.g., the outer surface of the roller 550 may be tangential to the surface of the sheath 118). The rollers 550 may be held in place using clamps along the circular axis 551 or using clamps at the distal edge 553 of each roller. Each roller may define an outer surface 552 facing the longitudinal axis 126, such that the outer surface 552 of the roller 550 can contact the surface of the sheath 118. Furthermore, the outer surface 552 of the roller 550 may be configured to engage the sheath 118 to imprint features onto the sheath 118. In one or more embodiments, the outer surface 552 of the roller 550 may define a profile that follows the curved surface of the sheath 118. Therefore, the entire outer surface 552 of the roller 550 can contact the sheath 118 (e.g., to increase the amount of contact area).

[0113] The outer surfaces of one or more rollers 550 can define any suitable textured pattern. The textured pattern of the rollers can be pressed against the sheath to imprint an opposite texture onto the sheath 118. The textured pattern of the rollers can form various features on the sheath 118, such as channels, protrusions, recesses, bumps, etc. Each of these features imprinted onto the sheath 118 may be desired to achieve specific characteristics of the surface of the sheath 118 as described herein. Additionally, one or more rollers 550 can define any suitable width. For example, one or more rollers 550 can define widths of approximately greater than or equal to 0.5 mm, greater than or equal to 1 mm, etc., and / or less than or equal to 2 mm, less than or equal to 1.5 mm. The width of the rollers 550 determines the amount of contact area between the rollers 550 and the sheath 118.

[0114] In one or more embodiments, the roller 550 may include radial clamps such that the width of the roller 550 can be defined as a percentage of the circumference of the sheath 118. In other words, the roller 550 may define a semi-circular shape at its outer surface 552 (which may be configured to engage a predetermined amount of the sheath 118). Multiple rollers may be combined to surround the circumference of the sheath 118 and modify that portion of the sheath 118. For example, in one embodiment, the system may include three rollers positioned around the sheath 118 such that each roller 550 engages one-third of the circumference of the sheath 118.

[0115] Additionally, in one or more embodiments, the system may include more than one set of rollers (e.g., similar to straightening rollers) along the axis of the sheath 118. In other embodiments, the rollers 550 may be arranged to shape and define the curve of the sheath within the system 100 (e.g., to bend the sheath 118 away from the longitudinal axis 126).

[0116] Furthermore, in one or more embodiments, the controller may be configured to position one or more rollers 550 in an engaged position and a spaced-out position. For example, one or more rollers 550 may be configured to move toward and contact the sheath 118 when in the engaged position and to move away from the sheath 118 when in the spaced-out position. One or more rollers 550 may move in any direction and orientation suitable for creating features on the surface of the sheath 118. For example, in one embodiment, the rollers 550 may be rotatably moved about the sheath 118 about a longitudinal axis.

[0117] One or more rollers 550 may include any suitable number of rollers. For example, one or more rollers 550 may include one, two, three, four, or more rollers. In one or more embodiments, the multiple rollers 550 may be equally spaced. In other embodiments, the multiple rollers 550 may be adjacent to each other. In one or more embodiments, the multiple rollers 550 may be configured to move independently of each other.

[0118] One or more rollers 550 may be positioned relative to the heating cylinder (e.g., the substrate outlet port) in any suitable manner. For example, in one or more embodiments, one or more rollers 550 may be located distal to the substrate outlet port. In other embodiments, one or more rollers 550 may be located proximal to the substrate outlet port (e.g., between the outlet die and the inlet die). Additionally, in one or more embodiments, one or more rollers 550 may be directly attached to the heating cylinder (e.g., attached to the outlet die 555). In other embodiments, one or more rollers 550 may be spaced apart from the heating cylinder. In such embodiments, one or more rollers 550 may move with the heating cylinder to perform post-processing of the sheath after sheath formation.

[0119] Figure 13 The use of system 100 is shown. Figure 1 This is an example of an additive manufacturing method 800. Method 800 can be used to manufacture implantable medical devices.

[0120] Method 800 may include, for example, feeding substrate 802 through a substrate channel in a heated barrel. The substrate channel may be in fluid communication with an internal cavity of the heated barrel.

[0121] Method 800 may include feeding one or more filaments 804. For example, at least a first filament may be fed into the internal cavity through a filament port of a heated barrel. In some embodiments, a second filament may be fed into the internal cavity through another filament port.

[0122] Method 800 may include, for example, melting one or more filaments 806 within an internal cavity. Any portion of the filament housed within the internal cavity may be melted. In some embodiments, a second filament is melted together with the first filament.

[0123] Method 800 may include, for example, moving a heated barrel relative to a substrate 808 at least in the longitudinal direction to form a 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.

[0124] Method 800 may also include modifying the sheath 810 to define sheath features. These sheath features may include any suitable features as described herein to modify the characteristics of the formed medical device. For example, sheath features may allow interaction with specific geometries and anatomical features. In other words, sheath features may allow control of frictional interfaces and the creation of fixing or anchoring components on the outer surface of the sheath body (e.g., enabling the sheath features to perform various "tasks"). Furthermore, sheath features may help stabilize the medical device during device movement, provide visual markings, or adjust the mechanical properties of the device.

[0125] The sheath feature may take various shapes. For example, in one or more embodiments, the sheath feature may include threads with different / variable pitches added to the surface of the sheath. In one or more embodiments, the sheath feature may include longitudinal splines added to the outer surface of the sheath, such as those described in U.S. Patent Application 63 / 001,832 entitled “3D PRINTED SPLINES ON MEDICAL DEVICES AND METHODS TO MANUFACTURE THE SAME,” which is incorporated herein by reference. In one or more embodiments, the sheath feature may include elongated structures added to the surface of the sheath to, for example, alter the overall shape profile of the sheath (e.g., wings or bi-convex angles, triangles, box / cubes, etc.). In one or more embodiments, the sheath feature may include intermittent surface bulges (e.g., discontinuous variations in thickness / diameter). In one or more embodiments, the sheath feature may include varying output geometries of the outer surface of the sheath (e.g., tapered).

[0126] As described herein, these externally added three-dimensional surface features of the sheath can benefit the performance of the medical device or delivery system by, for example, modifying the friction of the interface surface between the medical device body and the patient's anatomy, creating an anchoring mechanism for screwing or threading the medical device into the annular / cylindrical anatomical features, or creating preferred performance characteristics (e.g., bending, straightening, torsion, etc.).

[0127] Furthermore, these sheath features can be formed using any suitable tool. For example, the tools and processes described herein provide ways to design and develop medical device features and methods to manufacture such medical device features. Specifically, as described herein, the sheath can be modified by adjusting the shape and / or size of the sheath using a gate, by trimming a portion of the sheath using one or more cutting tools, by depositing additional filaments onto the sheath using an additional guide sheath, or by imprinting texture onto the sheath using one or more rollers, etc.

[0128] In addition, in some embodiments, method 800 may also include adjusting the ratio of the first filament to the second filament in the longitudinal distance to change the Shore hardness of the catheter sheath in the longitudinal distance.

[0129] Figure 14 The use of system 100 is shown. Figure 1 Another example of additive manufacturing method 820. Method 820 can be used to manufacture implantable medical devices.

[0130] Method 820 may include, for example, feeding substrate 822 through a substrate channel in a heated barrel. The substrate channel may be in fluid communication with an internal cavity of the heated barrel.

[0131] Method 820 may include feeding one or more filaments 824. For example, at least a first filament may be fed into the internal cavity through a filament port of a heated barrel. In some embodiments, a second filament may be fed into the internal cavity through another filament port.

[0132] Method 820 may include, for example, melting one or more filaments 826 within an internal cavity. Any portion of the filament housed within the internal cavity may be melted. In some embodiments, a second filament is melted together with the first filament.

[0133] Method 820 may include, for example, moving a heated barrel relative to a substrate 828 at least in the longitudinal direction to form a 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.

[0134] Method 820 may further include changing the movement rate 830 between the heating barrel and the substrate to define the sheath feature. For example, the controller may be configured to change the longitudinal speed of the substrate relative to the heating barrel. By changing the movement speed of these components relative to each other during sheath formation, the thickness of the sheath can be varied in the longitudinal distance. Thus, the sheath can define a circumferential protrusion extending from the outer surface of the sheath, for example, as... Figure 11 As shown. As described herein, these intermittent variations in the surface bulges of the sheath can provide the sheath with varying properties. Additionally, in one or more embodiments, the controller can change the longitudinal velocity of the substrate relative to the heated barrel to define a tapered shape on the outer surface of the sheath. Specifically, in one example, the tapering can modify the sheath thickness from 9 Frenchies to 7 Frenchies. Furthermore, in one or more embodiments, the system may include... Figure 12 The heated barrel shown (e.g., a tunnel die) provides a tapered shape when using varying longitudinal speeds.

[0135] In addition, in some embodiments, method 820 may also include adjusting the ratio of the first filament to the second filament in the longitudinal distance to change the Shore hardness of the catheter sheath in the longitudinal distance.

[0136] Figure 15 The use of system 100 is shown. Figure 1 This is yet another example of additive manufacturing method 840. Method 840 can be used to manufacture implantable medical devices.

[0137] Method 840 may include, for example, feeding substrate 842 through a substrate channel in a heated barrel. The substrate channel may be in fluid communication with an internal cavity of the heated barrel.

[0138] Method 840 may include feeding one or more filaments 844. For example, at least a first filament may be fed into the internal cavity through a filament port of a heated barrel. In some embodiments, a second filament may be fed into the internal cavity through another filament port.

[0139] Method 840 may include, for example, melting one or more filaments 846 within an internal cavity. Any portion of the filament housed within the internal cavity may be melted. In some embodiments, a second filament is melted together with the first filament.

[0140] Method 840 may include, for example, moving a heated barrel relative to a substrate 848 at least in the longitudinal direction to form a 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.

[0141] Method 840 may further include changing the feed rate 850 of the first filament through the filament port to define a sheath feature. For example, the controller may be configured to change the feed force applied to one or more filaments. By changing the feed force of one or more filaments during sheath formation, the thickness of the sheath can be changed in the longitudinal distance. Thus, the sheath can define a circumferential protrusion extending from the outer surface of the sheath, for example, as... Figure 11 As shown. As described herein, these intermittent variations in the surface bulges of the sheath can provide the sheath with varying properties. Additionally, in one or more embodiments, the controller can vary the feed force applied to one or more filaments to define a tapering of the outer surface of the sheath. Specifically, in one example, the tapering can modify the sheath thickness from 9 Frenchies to 7 Frenchies. Furthermore, in one or more embodiments, the system may include... Figure 12 The heated barrel shown is designed to provide a conical shape when using varying feed forces.

[0142] In addition, in some embodiments, method 820 may also include adjusting the ratio of the first filament to the second filament in the longitudinal distance to change the Shore hardness of the catheter sheath in the longitudinal distance.

[0143] Explanatory Implementation Plan

[0144] 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 embodiments and illustrative embodiments, as well as other embodiments of this disclosure, will become apparent herein.

[0145] A1. An additive manufacturing apparatus, comprising:

[0146] A heating block that at least partially defines an internal volume to allow an elongated substrate to pass through the internal volume and through the heating block, wherein the heating block at least partially defines a first filament port in fluid communication with the internal volume;

[0147] A first guide sheath, coupled to the heating block and extending from the outside of the heating block into the first filament port, defines a lumen in fluid communication with the internal volume; and

[0148] An outlet die, positioned distally to the heating block and at least partially defining the internal volume, wherein the outlet die at least partially defines a substrate outlet for the elongated substrate, wherein the substrate outlet is adapted to be selectively adjusted to modify the size and / or shape of the substrate outlet.

[0149] A2. The device according to embodiment A1 further includes a gate defining an opening longitudinally spaced from the substrate outlet, wherein the gate includes a body portion and one or more fins, the one or more fins being movably coupled to the body portion such that the one or more fins are adapted to move relative to the substrate outlet to modify the size and / or shape of the substrate outlet.

[0150] A3. The device according to embodiment A2, wherein each of the one or more fins extends between a first end region movably coupled to the body portion and a second end region adapted to move relative to the substrate outlet.

[0151] A4. The device according to embodiment A3, wherein the gate further includes one or more links, wherein each link corresponds to a fin in the one or more fins, wherein each link extends between a first end region movably connected to the body portion and a second end region movably connected to the corresponding fin, wherein the body portion defines one or more slots, and each link is movably connected within the one or more slots.

[0152] A5. The device according to embodiment A2, wherein the gate is located on the far side of the substrate outlet.

[0153] A6. The device according to embodiment A2, wherein the gate is located near the substrate outlet.

[0154] A7. The device according to embodiment A2, wherein the gate is directly attached to the outlet mold head.

[0155] A8. The device according to embodiment A2, wherein the gate is spaced apart from the outlet die.

[0156] A9. The device according to any of the preceding embodiments A further includes an inlet die that at least partially defines a substrate inlet port, wherein the internal volume is at least partially defined by the inlet die coupled to the proximal side of the heating block.

[0157] A10. The device according to any of the preceding embodiments A, wherein the substrate outlet port defines one, two, three, four or more cuts.

[0158] A11. The device according to any of the preceding embodiments A, wherein the substrate outlet port defines one, two, three, four or more protrusions.

[0159] A12. The device according to any of the preceding embodiments A, wherein the heating block at least partially defines a second filament port in fluid communication with the internal volume.

[0160] A13. The device according to any of the preceding embodiments A further includes one or more heating elements thermally connected to the heating block to melt the filament material in the internal volume.

[0161] B1. An additive manufacturing system, comprising:

[0162] A 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, the heating cylinder defining an internal volume and a substrate channel extending from the proximal side through the internal volume to the distal side, wherein the heating cylinder defines a first filament port in fluid communication with the internal volume to receive a first filament;

[0163] A heating element, thermally connected to the heating cylinder to heat the internal volume;

[0164] A filament processing system, the filament processing system including one or more motors for feeding at least a first filament into the internal volume through the first filament port;

[0165] Substrate processing system, the substrate processing system comprising:

[0166] Headframe, 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

[0167] One or more motors that cause one or both of the substrate fixed to the headstock and the heating cylinder to translate or rotate relative to each other;

[0168] A controller, operatively coupled to the heating element, the one or more motors of the filament processing system, and the one or more motors of the substrate processing system, is configured to:

[0169] Activate the heating element to melt any portion of the first filament in the internal volume;

[0170] Controlling one or more motors of the filament processing system to selectively control the feeding of the first filament into the internal volume; and

[0171] One or more motors of the substrate processing system are controlled to move one or both of the substrate and the heating cylinder relative to each other in at least the longitudinal direction to form an elongated conduit sheath around the substrate, wherein the conduit sheath comprises material from the first filament; and

[0172] A gate, the gate including a body portion defining a channel longitudinally spaced from the substrate outlet port of the heating cylinder, wherein the gate is adapted to be selectively adjusted to modify the size and / or shape of the substrate outlet port and engage the conduit sheath.

[0173] B2. The system according to embodiment B1, wherein the gate further includes one or more fins movably coupled to the body portion such that the one or more fins are configured to move relative to the substrate outlet port to modify the size and / or shape of the substrate outlet port.

[0174] B3. The system according to embodiment B2, wherein each of the one or more fins extends between a first end region movably coupled to the body portion and a second end region adapted to move relative to the substrate outlet.

[0175] B4. The system according to embodiment B3, wherein the gate further includes one or more links, wherein each link corresponds to a fin in the one or more fins, wherein each link extends between a first end region movably connected to the body portion and a second end region movably connected to the corresponding fin, wherein the body portion defines one or more slots, and each link is movably connected within the one or more slots.

[0176] B5. The system according to embodiment B2, wherein the gate is located on the far side of the substrate outlet port.

[0177] B6. The system according to embodiment B2, wherein the gate is located near the outlet port of the substrate.

[0178] B7. The system according to embodiment B2, wherein the gate is directly attached to the heating cylinder.

[0179] B8. The system according to embodiment B2, wherein the gate is spaced apart from the heating cylinder.

[0180] B9. The system according to any of the preceding embodiments B, wherein the heating cylinder further includes a second filament port in fluid communication with the internal volume, wherein the one or more motors of the filament processing system are adapted to feed a second filament into the internal volume through the second filament port, wherein the controller is configured to:

[0181] Activate the heating element to melt any portion of the second filament within the internal volume.

[0182] 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, wherein the conduit sheath comprises material from at least one of the first filament and the second filament.

[0183] B10. The system according to any of the preceding embodiments B, wherein the heating cylinder includes an inlet die, an outlet die, and a heating block, wherein the heating block defines the first filament port and the second filament port.

[0184] B11. The system according to any of the preceding embodiments B, wherein one or both of the substrate inlet port and the substrate outlet port define one, two, three, four or more cuts, and the controller is configured to rotate the substrate relative to the heating cylinder while translating the substrate relative to the heating cylinder to form the elongated conduit sheath around the substrate.

[0185] B12. The system according to embodiment B11, wherein the substrate outlet port defines the one, two, three, four or more incisions, and the catheter sheath includes a plurality of helical protrusions corresponding to the number of incisions.

[0186] B13. The system according to any of the preceding embodiments B, wherein one or both of the substrate inlet port and the substrate outlet port define one, two, three, four or more protrusions.

[0187] B14. The system according to embodiment B13, wherein the substrate outlet port includes the one, two, three, four or more protrusions, and the conduit sheath includes a corresponding number of channels.

[0188] B15. The system according to any of the preceding embodiments B, wherein the controller is configured to move the headstock away from the heating cylinder in at least the longitudinal direction to form the conduit sheath.

[0189] B16. The system according to any of the preceding embodiments B, wherein the substrate processing system includes a tailstock, the tailstock including a proximal clamp to secure a proximal portion of the substrate.

[0190] B17. The system according to embodiment B16, wherein the controller is configured to move the heating cylinder away from the headstock in at least the longitudinal direction to form the conduit sheath.

[0191] B18. The system according to any of the preceding embodiments B further includes the substrate, wherein the substrate includes a lubricating coating, a liner, and a braid, and the conduit sheath is formed around the braid.

[0192] C1. An additive manufacturing apparatus, comprising:

[0193] A heating block that at least partially defines an internal volume to allow an elongated substrate to pass through the internal volume and through the heating block along a longitudinal axis, wherein the heating block at least partially defines a first filament port in fluid communication with the internal volume;

[0194] A first guide sheath is coupled to the heating block and extends from the outside of the heating block into the first filament port, the first guide sheath defining a lumen in fluid communication with the internal volume;

[0195] An outlet die, positioned distally to the heating block and at least partially defining the internal volume, wherein the outlet die at least partially defines a substrate outlet for the elongated substrate; and

[0196] One or more cutting tools, the one or more cutting tools being longitudinally spaced from the substrate outlet, wherein each of the one or more cutting tools includes a cutting edge oriented toward the longitudinal axis.

[0197] C2. The device according to any of the preceding embodiments C, wherein each of the one or more cutting tools extends along a cutting axis between the base edge and the cutting edge, wherein the cutting axis is positioned at an angle of less than or equal to about 45 degrees relative to the longitudinal axis.

[0198] C3. The device according to any of the preceding embodiments of C, wherein the one or more cutting tools are movably coupled to the exit die head.

[0199] C4. The device according to any of the preceding embodiments of C, wherein the one or more cutting tools are configured to move between an engaged position and a spaced-out position.

[0200] C5. The device according to any of the preceding embodiments of C, wherein the cutting edge is positioned between the edge of the substrate outlet and the longitudinal axis.

[0201] C6. The device according to any of the preceding embodiments of C, wherein the one or more cutting tools comprise one, two, three or four cutting tools.

[0202] C7. The device according to any of the preceding embodiments of C, wherein the one or more cutting tools are located distal to the substrate outlet.

[0203] C8. The apparatus according to embodiments C1 to C6, wherein one or more cutting tools are located near the substrate outlet.

[0204] C9. The device according to any of the preceding embodiments of C, wherein the one or more cutting tools are directly attached to the exit die head.

[0205] C10. The apparatus according to embodiments C1 to C8, wherein the one or more cutting tools are spaced apart from the exit die head.

[0206] D1. An additive manufacturing system, comprising:

[0207] A 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, the heating cylinder defining an internal volume and a substrate channel extending from the proximal side through the internal volume to the distal side, wherein the heating cylinder defines a first filament port in fluid communication with the internal volume to receive a first filament;

[0208] A heating element, thermally connected to the heating cylinder to heat the internal volume;

[0209] A filament processing system, the filament processing system including one or more motors for feeding at least a first filament into the internal volume through the first filament port;

[0210] Substrate processing system, the substrate processing system comprising:

[0211] Headframe, 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 along a longitudinal axis when secured by the headframe; and

[0212] One or more motors that cause one or both of the substrate fixed to the headstock and the heating cylinder to translate or rotate relative to each other;

[0213] A controller, operatively coupled to the heating element, the one or more motors of the filament processing system, and the one or more motors of the substrate processing system, is configured to:

[0214] Activate the heating element to melt any portion of the first filament in the internal volume;

[0215] Controlling one or more motors of the filament processing system to selectively control the feeding of the first filament into the internal volume; and

[0216] One or more motors of the substrate processing system are controlled to move one or both of the substrate and the heating cylinder relative to each other in at least the longitudinal direction to form an elongated conduit sheath around the substrate, wherein the conduit sheath comprises material from the first filament; and

[0217] One or more cutting tools, the one or more cutting tools being longitudinally spaced from the substrate outlet port of the heating cylinder, each of the one or more cutting tools including a cutting edge oriented toward the longitudinal axis and configured to selectively engage the conduit sheath.

[0218] D2. The system according to any of the preceding embodiments D, wherein each of the one or more cutting tools extends along a cutting axis between the base edge and the cutting edge, wherein the cutting axis is positioned at an angle of less than or equal to about 45 degrees relative to the longitudinal axis.

[0219] D3. The system according to any of the preceding embodiments D, wherein the one or more cutting tools are movably coupled to the heated barrel.

[0220] D4. The system according to any of the preceding embodiments D, wherein the one or more cutting tools are configured to move between an engaged position and a spaced-out position.

[0221] D5. The system according to any of the preceding embodiments D, wherein the cutting edge is positioned between the edge of the substrate outlet and the longitudinal axis.

[0222] D6. The system according to any of the preceding embodiments D, wherein the one or more cutting tools include one, two, three or four cutting tools.

[0223] D7. The system according to any of the preceding embodiments D, wherein the one or more cutting tools are located distal to the substrate outlet port.

[0224] D8. The system according to embodiments D1 to D6, wherein one or more cutting tools are located near the substrate outlet port.

[0225] D9. The system according to any of the preceding embodiments D, wherein the one or more cutting tools are directly attached to the heated barrel.

[0226] D10. The system according to embodiments D1 to D8, wherein the one or more cutting tools are spaced apart from the heated barrel.

[0227] E1. An additive manufacturing apparatus, comprising:

[0228] A heating block that at least partially defines an internal volume to allow an elongated substrate to pass through the internal volume and through the heating block along a longitudinal axis, wherein the heating block at least partially defines a first filament port in fluid communication with the internal volume;

[0229] A first guide sheath is coupled to the heating block and extends from the outside of the heating block into the first filament port, the first guide sheath defining a lumen in fluid communication with the internal volume;

[0230] An outlet die, positioned distally to the heating block and at least partially defining the internal volume, wherein the outlet die at least partially defines a substrate outlet for the elongated substrate; and

[0231] An additional guide sheath is provided on the distal side of the outlet die and defines an additional filament lumen configured to receive the additional filament.

[0232] E2. The device according to any of the preceding embodiments E, wherein the additional guide sheath is directly attached to the outlet die.

[0233] E3. The device according to embodiment E1, wherein the additional guide sheath is spaced apart from the outlet die.

[0234] F1. An additive manufacturing system, comprising:

[0235] A 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, the heating cylinder defining an internal volume and a substrate channel extending from the proximal side through the internal volume to the distal side, wherein the heating cylinder defines a first filament port in fluid communication with the internal volume to receive a first filament;

[0236] A heating element, thermally connected to the heating cylinder to heat the internal volume;

[0237] A filament processing system, the filament processing system including one or more motors for feeding at least a first filament into the internal volume through the first filament port;

[0238] Substrate processing system, the substrate processing system comprising:

[0239] Headframe, 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 along a longitudinal axis when secured by the headframe; and

[0240] One or more motors that cause one or both of the substrate fixed to the headstock and the heating cylinder to translate or rotate relative to each other;

[0241] A controller, operatively coupled to the heating element, the one or more motors of the filament processing system, and the one or more motors of the substrate processing system, is configured to:

[0242] Activate the heating element to melt any portion of the first filament in the internal volume;

[0243] Controlling one or more motors of the filament processing system to selectively control the feeding of the first filament into the internal volume; and

[0244] One or more motors of the substrate processing system are controlled to move one or both of the substrate and the heating cylinder relative to each other in at least the longitudinal direction to form an elongated conduit sheath around the substrate, wherein the conduit sheath comprises material from the first filament; and

[0245] An additional guiding sheath, located distal to the heating block and defining an additional filament lumen configured to receive an additional filament, wherein the additional guiding sheath is configured to selectively deposit the additional filament onto the catheter sheath.

[0246] F2. The system according to any of the preceding embodiments F, wherein the additional guide sheath is directly attached to the heating cylinder.

[0247] F3. The system according to embodiment F1, wherein the additional guide sheath is spaced apart from the heating cylinder.

[0248] F4. The system according to any of the preceding embodiments F, wherein the additional guide sheath is configured to move relative to the elongated substrate.

[0249] F5. The system according to any of the preceding embodiments F, wherein the additional filament comprises the same material as the first filament.

[0250] F6. The system according to any of the preceding embodiments F, wherein the additional filament comprises a material different from the first filament.

[0251] F7. The system according to any of the preceding embodiments F, wherein the additional filament lumen includes a plurality of ports through which the additional filament is deposited on the catheter sheath.

[0252] G1. An additive manufacturing apparatus, comprising:

[0253] A heating block that at least partially defines an internal volume to allow an elongated substrate to pass through the internal volume and through the heating block along a longitudinal axis, wherein the heating block at least partially defines a first filament port in fluid communication with the internal volume;

[0254] A first guide sheath is coupled to the heating block and extends from the outside of the heating block into the first filament port, the first guide sheath defining a lumen in fluid communication with the internal volume;

[0255] An outlet die, positioned distally to the heating block and at least partially defining the internal volume, wherein the outlet die at least partially defines a substrate outlet for the elongated substrate; and

[0256] One or more rollers, the one or more rollers being longitudinally spaced from the substrate outlet, wherein each of the one or more rollers is configured to rotate about an axis perpendicular to the longitudinal axis and to define an outer surface facing the longitudinal axis.

[0257] G2. The device according to any of the preceding G embodiments, wherein each of the one or more rollers defines a width of about 1 mm.

[0258] G3. The device according to any of the preceding G embodiments, wherein the outer surface of the one or more rolling wheels defines a textured pattern.

[0259] G4. The device according to any of the preceding G embodiments, wherein the one or more rollers are configured to move laterally between an engaged position and a spaced position.

[0260] G5. The device according to any of the preceding G embodiments, wherein the one or more rollers comprise one, two, three or four rollers.

[0261] G6. The device according to any of the preceding G embodiments, wherein one or more rollers are located on the far side of the substrate outlet.

[0262] H1. An additive manufacturing system, comprising:

[0263] A 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, the heating cylinder defining an internal volume and a substrate channel extending from the proximal side through the internal volume to the distal side, wherein the heating cylinder defines a first filament port in fluid communication with the internal volume to receive a first filament;

[0264] A heating element, thermally connected to the heating cylinder to heat the internal volume;

[0265] A filament processing system, the filament processing system including one or more motors for feeding at least a first filament into the internal volume through the first filament port;

[0266] Substrate processing system, the substrate processing system comprising:

[0267] Headframe, 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 along a longitudinal axis when secured by the headframe; and

[0268] One or more motors that cause one or both of the substrate fixed to the headstock and the heating cylinder to translate or rotate relative to each other;

[0269] A controller, operatively coupled to the heating element, the one or more motors of the filament processing system, and the one or more motors of the substrate processing system, is configured to:

[0270] Activate the heating element to melt any portion of the first filament in the internal volume;

[0271] Controlling one or more motors of the filament processing system to selectively control the feeding of the first filament into the internal volume; and

[0272] One or more motors of the substrate processing system are controlled to move one or both of the substrate and the heating cylinder relative to each other in at least the longitudinal direction to form an elongated conduit sheath around the substrate, wherein the conduit sheath comprises material from the first filament; and

[0273] One or more rollers, the one or more rollers being longitudinally spaced from the substrate outlet port of the heating cylinder, wherein each of the one or more rollers is configured to rotate about an axis perpendicular to the longitudinal axis and defines an outer surface configured to engage the conduit sheath to imprint a feature thereon.

[0274] H2. The system according to any of the preceding H embodiments, wherein each of the one or more rollers defines a width of approximately 1 mm.

[0275] H3. The system according to any of the preceding H embodiments, wherein the outer surface of the one or more rolling wheels defines a textured pattern.

[0276] H4. The system according to any of the preceding H embodiments, wherein the one or more rollers are configured to move laterally between an engaged position and a spaced-out position.

[0277] H5. The system according to any of the preceding H embodiments, wherein the one or more rollers comprise one, two, three or four rollers.

[0278] H6. The system according to any of the preceding H embodiments, wherein one or more rollers are located on the far side of the substrate outlet port.

[0279] 11. A method for additive manufacturing of an implantable medical device, the method comprising:

[0280] The substrate is fed through a substrate channel in a heating cylinder, the substrate channel being in fluid communication with the internal cavity of the heating cylinder;

[0281] At least a first filament is fed into the internal cavity through the filament port;

[0282] The first filament is melted in the internal cavity;

[0283] The heated barrel is moved relative to the substrate at least in the longitudinal direction to form a sheath comprising material from at least the first filament; and

[0284] The sheath is modified to define the sheath feature portion.

[0285] I2. The method according to embodiment I1, wherein changing the catheter sheath includes using a gate to adjust the shape and / or size of the catheter sheath.

[0286] I3. The method according to embodiment I1, wherein altering the catheter sheath includes trimming a portion of the catheter sheath using one or more cutting tools.

[0287] I4. The method according to embodiment I1, wherein modifying the catheter sheath includes depositing additional filaments onto the catheter sheath using an additional guide sheath.

[0288] I5. The method according to embodiment I1, wherein altering the catheter sheath includes using one or more rollers to emboss a texture onto the catheter sheath.

[0289] 16. The method according to any of the preceding embodiments, wherein the catheter sheath feature includes a tapered outer surface of the catheter sheath.

[0290] 17. The method according to any of the preceding embodiments, wherein the catheter sheath feature includes a circumferential protrusion extending from the outer surface of the catheter sheath.

[0291] 18. The method according to any of the preceding embodiments, wherein the catheter sheath feature includes a variable spline extending from the outer surface of the catheter sheath.

[0292] 19. The method according to any of the preceding embodiments further includes:

[0293] The second filament is fed into the internal cavity through another filament port; and

[0294] The second filament is melted together with the first filament to form the catheter sheath comprising material from at least the first filament and the second filament.

[0295] I10. The method according to embodiment I9 further includes adjusting the ratio of the first filament to the second filament in the longitudinal distance to change the Shore hardness of the catheter sheath in the longitudinal distance.

[0296] J1. A method for additive manufacturing of an implantable medical catheter, the method comprising:

[0297] The substrate is fed through a substrate channel in a heating cylinder, the substrate channel being in fluid communication with the internal cavity of the heating cylinder;

[0298] At least a first filament is fed into the internal cavity through the filament port;

[0299] The first filament is melted in the internal cavity;

[0300] The heated barrel is moved relative to the substrate at least in the longitudinal direction to form a conduit sheath comprising material from at least the first filament; and

[0301] The movement rate between the heating cylinder and the substrate is changed to define the conduit sheath feature.

[0302] J2. The method according to embodiment J1, wherein the catheter sheath feature includes a tapered shape on the outer surface of the catheter sheath.

[0303] J3. The method according to embodiment J1, wherein the catheter sheath feature includes a circumferential protrusion extending from the outer surface of the catheter sheath.

[0304] K1. A method for additive manufacturing of an implantable medical catheter, the method comprising:

[0305] The substrate is fed through a substrate channel in a heating cylinder, the substrate channel being in fluid communication with the internal cavity of the heating cylinder;

[0306] At least a first filament is fed into the internal cavity through the filament port;

[0307] The first filament is melted in the internal cavity;

[0308] The heated barrel is moved relative to the substrate at least in the longitudinal direction to form a conduit sheath comprising material from at least the first filament; and

[0309] The feed rate of the first filament through the filament port is changed to define the catheter sheath feature.

[0310] K2. The method according to embodiment K1, wherein the catheter sheath feature includes a tapered shape on the outer surface of the catheter sheath.

[0311] K3. The method according to embodiment K1, wherein the catheter sheath feature includes a circumferential protrusion extending from the outer surface of the catheter sheath.

[0312] Therefore, various embodiments described herein are disclosed. It should be understood that the various 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 process or method described herein may be performed in a different order, and may be completely added, combined, or omitted (e.g., performing the described technique 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.

[0313] 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).

[0314] 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.

[0315] 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.

[0316] Unless otherwise specified, all numerical values ​​used in the specification and claims to represent characteristic dimensions, quantities, and physical properties are to be understood as being modified by the terms “precisely” or “about”. Therefore, unless indicated to the contrary, the numerical parameters set forth in the foregoing specification and appended claims are approximate values ​​that may vary within typical ranges of experimental error, depending on the desired properties sought by a person skilled in the art using the teachings disclosed herein.

[0317] 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.

[0318] Unless the context clearly specifies otherwise, the singular forms “a,” “an,” and “the” cover implementations with plural indicators.

[0319] As used in this article, "have," "having," "include," "including," "comprise," and "comprising" are used in their open-ended sense and usually mean "including but not limited to." It should be understood that phrases such as "basically composed of" or "composed of" are categorized under "comprising."

[0320] 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 shortened terms 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.

[0321] The terms "preferred" and "ideally" 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 additive manufacturing apparatus, comprising: A heating block that at least partially defines an internal volume to allow an elongated substrate to pass through the internal volume and through the heating block, wherein the heating block at least partially defines a first filament port in fluid communication with the internal volume; A first guide sheath is coupled to the heating block and extends from the outside of the heating block into the first filament port, the first guide sheath defining a lumen in fluid communication with the internal volume; and An outlet die, positioned distally to the heating block and at least partially defining the internal volume, wherein the outlet die at least partially defines a substrate outlet for the elongated substrate, wherein the substrate outlet is adapted to be selectively adjusted to modify the size and / or shape of the substrate outlet.

2. The device of claim 1, further comprising a gate defining an opening longitudinally spaced from the substrate outlet, wherein the gate includes a body portion and one or more fins movably coupled to the body portion such that the one or more fins are adapted to move relative to the substrate outlet to modify the size and / or shape of the substrate outlet.

3. The device of claim 2, wherein each of the one or more fins extends between a first end region movably coupled to the body portion and a second end region adapted to move relative to the substrate outlet.

4. The device of claim 3, wherein the gate further comprises one or more links, wherein each link corresponds to a fin in the one or more fins, wherein each link extends between a first end region movably connected to the body portion and a second end region movably connected to the corresponding fin, wherein the body portion defines one or more slots in which each link is movably connected.

5. The device according to claim 2, wherein the gate is located on the far side of the substrate outlet.

6. The device of claim 2, wherein the gate is located near the substrate outlet.

7. The device according to claim 2, wherein the gate is directly attached to the outlet die.

8. The device according to any one of claims 1 to 7, wherein the heating block at least partially defines a second filament port in fluid communication with the internal volume.

9. An additive manufacturing system, comprising: A 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, the heating cylinder defining an internal volume and a substrate channel extending from the proximal side through the internal volume to the distal side, wherein the heating cylinder defines a first filament port in fluid communication with the internal volume to receive a first filament; A heating element, thermally connected to the heating cylinder to heat the internal volume; A filament processing system, the filament processing system including one or more motors for feeding at least a first filament into the internal volume through the first filament port; Substrate processing system, the substrate processing system comprising: Headframe, the headframe including a distal clamp for securing a distal portion of an elongated substrate, wherein the elongated 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 elongated substrate fixed by the head frame and the heating cylinder to translate or rotate relative to each other; A controller, operatively coupled to the heating element, the one or more motors of the filament processing system, and the one or more motors of the substrate processing system, is configured to: Activate the heating element to melt any portion of the first filament in the internal volume; Controlling one or more motors of the filament processing system to selectively control the feeding of the first filament into the internal volume; and One or more motors of the substrate processing system are controlled to move one or both of the elongated substrate and the heating cylinder relative to each other in at least the longitudinal direction to form an elongated conduit sheath around the elongated substrate, wherein the conduit sheath comprises material from the first filament; and A gate, the gate including a body portion defining a channel longitudinally spaced from the substrate outlet port of the heating cylinder, wherein the gate is adapted to be selectively adjusted to modify the size and / or shape of the substrate outlet port and engage the conduit sheath.

10. The system of claim 9, wherein the gate further comprises one or more fins movably coupled to the body portion such that the one or more fins are configured to move relative to the substrate outlet port to modify the size and / or shape of the substrate outlet port.

11. The system of claim 10, wherein each of the one or more fins extends between a first end region movably coupled to the body portion and a second end region adapted to move relative to the substrate outlet.

12. The system of claim 11, wherein the gate further comprises one or more links, wherein each link corresponds to a fin in the one or more fins, wherein each link extends between a first end region movably coupled to the body portion and a second end region movably coupled to the corresponding fin, wherein the body portion defines one or more slots in which each link is movably coupled.

13. The system according to any one of claims 9 to 12, wherein the heating cylinder further comprises a second filament port in fluid communication with the internal volume, wherein the one or more motors of the filament processing system are adapted to feed a second filament into the internal volume through the second filament port, wherein the controller is configured to: Activate the heating element to melt any portion of the second filament within the internal volume. 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, wherein the conduit sheath comprises material from at least one of the first filament and the second filament.

14. The system according to any one of claims 9 to 12, wherein the controller is configured to move the heating cylinder away from the headstock in at least the longitudinal direction to form the conduit sheath.

15. The system according to any one of claims 9 to 12, further comprising the elongated substrate, wherein the elongated substrate comprises a lubricating coating, a liner, and a braid, and the conduit sheath is formed around the braid.

16. A method for additive manufacturing of an implantable medical device, the method comprising: The substrate is fed through a substrate channel in a heating cylinder, the substrate channel being in fluid communication with the internal cavity of the heating cylinder; At least a first filament is fed into the internal cavity through the filament port; The first filament is melted in the internal cavity; The heating cylinder is moved relative to the substrate at least in the longitudinal direction to form a sheath comprising material from at least the first filament; as well as The sheath is modified to define the sheath feature portion.

17. The method of claim 16, wherein changing the sheath comprises using a gate to adjust the shape and / or size of the sheath.

18. The method of claim 16, wherein the sheath feature includes a variable spline extending from the outer surface of the sheath.

19. The method according to any one of claims 16 to 18, further comprising: The second filament is fed into the internal cavity through another filament port; as well as The second filament is melted together with the first filament to form the sheath comprising material from at least the first filament and the second filament.

20. The method of claim 19, further comprising adjusting the ratio of the first filament to the second filament in the longitudinal distance to change the Shore hardness of the sheath in the longitudinal distance.

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