3d-printed splines on medical devices and methods of making the same

Abstract

An elongated medical device (100, 200, 300, 400, 500, 600, 700) and a method of manufacturing the same are disclosed. The device includes a base element (110, 210, 310, 410, 510, 610, 710) and at least one spline (130, 230, 330, 430, 530, 630, 730). The base element and the at least one spline may comprise various materials to define various properties of the device. For example, the base element may comprise a first material and define a lumen therein. At least one spline may protrude from an outer surface of the base element and may comprise a second material. In one or more embodiments, at least one spline may extend along a helical path.

Description

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 001,832, filed on March 30, 2020, which is incorporated herein by reference in its entirety.

[0002] This disclosure generally relates to medical devices, particularly the additive manufacturing or 3D printing of medical devices including splines, 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 and perform various functions therein. 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 turns or curves in the vascular system, yet rigid or resilient enough to be propelled through it. In many cases, such as those involving cardiovascular vessels, the route to the treatment or deployment site can be tortuous, potentially leading to conflicting design considerations and requiring trade-offs in size, flexibility, material selection, and operational control. Furthermore, the aforementioned medical catheters and leads may include splined features (e.g., helical splines) for advancing medical devices within the body and / or temporarily or permanently anchoring them. These different characteristics can present challenges in designing and manufacturing such catheters and leads.

[0004] Existing manufacturing processes, such as polymer molding technology, may pose challenges in forming splines extending from conduits and leads. Furthermore, using polymer molding technology to form splines from different materials with different shapes and orientations relative to conduits and leads can also prove challenging. Summary of the Invention

[0005] The technology disclosed herein generally relates to the additive manufacturing of medical devices, such as catheters and leads, which allows the formation of one or more splines extending from the outer surface of the catheter / lead. For example, additive manufacturing or three-dimensional (3D) printing can be used to form one or more splines. Therefore, the one or more splines can be made of a variety of different materials (e.g., exhibiting different degrees of hardness), which may be the same as or different from the material of the catheter and / or lead on which the one or more splines are placed. Furthermore, the one or more splines can extend along a helical path on the outer surface of the catheter and / or lead.

[0006] An exemplary elongated implantable medical device may include a base element and at least one spline. The base element may extend longitudinally between a distal and a proximal end. The base element may include a first material and may include a lumen. The at least one spline may protrude from at least the distal end of the outer surface of the base element, partially covering only the outer surface. The at least one spline may include a second material. The first material may define a first Shore hardness that is different from a second Shore hardness of the second material.

[0007] In one or more embodiments, at least one spline may extend along a helical path on the outer surface of the base element.

[0008] In one or more embodiments, at least one spline may include a plurality of splines extending longitudinally.

[0009] In one or more embodiments, the base element may include at least one of braided yarn and an inner lining.

[0010] An exemplary elongated implantable medical device may include a base element and at least one spline. The base element may extend longitudinally between a distal and a proximal end. The base element may include a first material and may define a lumen therein. At least one spline may protrude from an outer surface of the base element at least near the distal end. At least one spline may include a second material, and the second material may include a bioresorbable material.

[0011] In one or more embodiments, the second material may include a steroid material.

[0012] In one or more embodiments, the second material may include a pharmaceutical product and a polymer.

[0013] In one or more embodiments, the second material may include a drug contained in a porous silicon material.

[0014] An exemplary elongated implantable medical device may include a base element and at least one spline. The base element may extend longitudinally between a distal and a proximal end. The base element may include a first material and may define a lumen therein. At least one spline may protrude from an outer surface of the base element at least near the distal end. At least one spline may include a second material, and the second material may include a steroid material.

[0015] An exemplary elongated implantable medical device may include a base element and at least one spline. The base element may extend longitudinally between a distal and a proximal end. The base element may define a lumen therein. At least one spline may protrude from an outer surface of the base element at least near the distal end. The at least one spline may include a first longitudinal segment extending longitudinally and comprising a first material, and a second longitudinal segment extending longitudinally and comprising a second material. The first longitudinal segment may be proximate to or adjacent to the second longitudinal segment.

[0016] In one or more embodiments, at least one spline may extend along a helical path on the outer surface of the base element.

[0017] In one or more embodiments, at least one spline may include a plurality of splines extending longitudinally.

[0018] In one or more embodiments, the first material may define a first Shore hardness that is different from the second Shore hardness of the second material.

[0019] An exemplary elongated implantable medical device may include a base element and at least one spline. The base element may extend longitudinally between a distal and a proximal end. The base element may include a first portion extending longitudinally and comprising a first material, and a second portion extending longitudinally and comprising a second material. The first portion may extend proximally to or adjacent to the second portion. The base element may define a lumen therein. At least one spline may protrude from at least the outer surface of at least one of the first and second portions near the distal end.

[0020] In one or more embodiments, at least one spline may extend along a helical path on the outer surface of the base element.

[0021] In one or more embodiments, at least one spline may include a plurality of splines extending longitudinally.

[0022] In one or more embodiments, the first material may define a first Shore hardness that is different from the second Shore hardness of the second material.

[0023] In one or more embodiments, at least one spline may include a first spline, and optionally a second spline. The first spline may include a first material and may protrude from the outer surface of a first portion. The optional second spline may include a second material and may protrude from the outer surface of a second portion.

[0024] In one or more embodiments, the first and second portions may extend along a spiral path.

[0025] In one or more embodiments, at least one spline may include a third material different from the first and second materials.

[0026] An exemplary elongated implantable medical device may include a base element and at least one spline. The base element may extend longitudinally between a distal and a proximal end. The base element may define a lumen therein. At least one spline may protrude from an outer surface of the base element, at least near the distal end. At least one spline may define a longitudinally extending fluid flow channel. At least one spline may be configured to prevent tissue intrusion into the fluid flow channel during device implantation.

[0027] In one or more embodiments, at least one spline may be configured to deflect toward the outer surface of the base element when the device is implanted, such that the surface of the at least one spline may define a fluid flow channel between the at least one spline and the outer surface of the base element.

[0028] In one or more embodiments, at least one spline may define an outermost surface radially, and the fluid flow channel may be defined by a groove in the outermost surface.

[0029] In one or more embodiments, the device may further include a hydrophilic material disposed in a groove of at least one spline.

[0030] In one or more embodiments, the device may further include a hydrophilic material disposed on at least one spline.

[0031] An exemplary elongated implantable medical device may include a base element and at least one spline. The base element may extend longitudinally between a distal and a proximal end. The base element may define a lumen therein. At least one spline may protrude from an outer surface of the base element, at least near the distal end. At least one spline may define a spline lumen extending through the at least one spline. At least one spline may comprise a flexible material such that at least one spline is expandable.

[0032] In one or more embodiments, at least one spline may include a first portion and a second portion, wherein the first portion includes a first material defining a first Shore hardness, and wherein the second portion includes a flexible material defining a second Shore hardness less than the first Shore hardness. The second portion may be disposed radially distal to the first portion.

[0033] In one or more embodiments, the base element may include a first material defining a first Shore hardness and a flexible material defining a second Shore hardness less than the first Shore hardness.

[0034] An exemplary elongated implantable medical device may include a base element and at least one spline. The base element may extend longitudinally between a distal and a proximal end. The base element may define a lumen therein, and the base element may include a flexible material such that the base element is expandable. At least one spline may protrude from the outer surface of the base element at least near the distal end. At least one spline may include a flexible material such that at least one spline is expandable.

[0035] An exemplary elongated implantable medical device may include a base element and at least one spline. The base element may extend longitudinally between a distal and a proximal end. The base element may define a lumen therein. At least one spline may protrude from an outer surface of the base element at least near the distal end. The at least one spline may include a first spline extending along a first helical path and a second spline extending along a second helical path in a direction of rotation opposite to the first helical path, such that the first spline and the second spline intersect.

[0036] In one or more embodiments, the first spline may protrude radially from the outer surface by a first distance, which is greater than the second spline protruding from the outer surface by a second distance.

[0037] In one or more embodiments, the second spline may protrude from the outer surface in a direction toward the proximal end.

[0038] In one or more embodiments, the first spline may include a first material, and the second spline may include a second material. The first material may define a first Shore hardness, which is less than a second Shore hardness of the second material.

[0039] An exemplary method for additive manufacturing of an implantable medical catheter may include feeding a substrate through a substrate channel in a heated cylinder. The substrate channel is in fluid communication with an inner cavity of the heated cylinder. Furthermore, the method may include feeding at least a first filament into the inner cavity through a filament port, melting the first filament in the inner cavity, and moving the heated cylinder relative to the substrate at least in a longitudinal direction and a first rotational direction to form a catheter sheath and a first spline projecting from an outer surface of the catheter sheath, the spline comprising material from the first filament. The first spline may extend along a first helical path. Additionally, the method may include moving a funnel element relative to the substrate at least in a longitudinal direction and a second rotational direction opposite to the first rotational direction to form a second spline projecting from an outer surface of the catheter sheath, the second spline comprising material from the first spline. The second spline may extend along a second helical path extending in a rotational direction opposite to the first helical path, such that the first and second splines intersect.

[0040] An exemplary elongated implantable medical device may include a base element and at least one spline. The base element may extend longitudinally between a distal and a proximal end. The base element may define a lumen therein. At least one spline may protrude from the outer surface of the base element, at least near the distal end. At least one spline may define a textured outermost surface to facilitate implantation.

[0041] In one or more embodiments, the textured outermost surface may define a plurality of pits.

[0042] In one or more embodiments, the textured outermost surface may define crosshairs.

[0043] In one or more embodiments, the textured outermost surface may define a plurality of microgrooves.

[0044] Details of one or more aspects of this disclosure are set forth in the accompanying drawings and description below. Other features, objectives, and advantages of the technology described in this disclosure will be apparent from the specification, drawings, and claims. Attached Figure Description

[0045] Figure 1 A side view of an elongated medical device according to the present disclosure is shown, the elongated medical device including one or more splines extending from its outer surface.

[0046] Figure 2A yes Figure 1 A cross-sectional view of an exemplary embodiment of an elongated medical device.

[0047] Figure 2B yes Figure 1 A cross-sectional view illustrating another embodiment of the slender medical device.

[0048] Figure 3 A side view of another exemplary embodiment of an elongated medical device having splines formed from two different materials is shown.

[0049] Figure 4 A side view of another exemplary embodiment of a slender medical device made of two different materials is shown.

[0050] Figure 5 A side view of another exemplary embodiment of a slender medical device having two different materials and including splines formed from the corresponding different materials is shown.

[0051] Figure 6 A side view of another exemplary embodiment of a slender medical device made of two different materials is shown.

[0052] Figure 7AIt is a cross-sectional view of a slender medical device that defines one or more flow channels between splines.

[0053] Figure 7B It is a cross-sectional view of a slender medical device, which defines one or more flow channels between the spline and the outer surface of the slender medical device.

[0054] Figure 7C It is a cross-sectional view of an elongated medical device that defines one or more flow channels in one or more splines.

[0055] Figure 8A It is a cross-sectional view of a slender medical device, which includes one or more splines defining its lumen.

[0056] Figure 8B Another embodiment of an elongated medical device is shown, which includes one or more splines defining its lumen.

[0057] Figure 8C This is a cross-sectional view of another slender medical device, which includes one or more splines defining its lumen.

[0058] Figure 8D This is an enlarged cross-sectional view of yet another slender medical device, which includes one or more splines embedded in a base element and defining its lumen.

[0059] Figure 9 A side view of a slender medical device is shown, which includes two splines extending along opposing helical paths.

[0060] Figure 10 yes Figure 9 A cross-sectional view of another exemplary embodiment of the elongated medical device.

[0061] Figure 11 The diagram shows... Figure 9 The outer surface of a slender medical device, which is projected along a plane.

[0062] Figure 12A It shows the image flattened on a horizontal plane. Figure 9 The side profile of the first spline of a slender medical device.

[0063] Figure 12B It shows the image flattened on a horizontal plane. Figure 9 The side profile of the second spline of a slender medical device.

[0064] Figure 13 It is a cross-sectional view of an elongated medical device comprising one or more splines with textured outermost surfaces.

[0065] Figure 14It is a flowchart that shows Figure 9-11 An embodiment of an additive manufacturing method for the elongated medical device shown.

[0066] Figure 15 The outer surface of an elongated medical device is shown, which includes two intersecting splines projected along a plane. Detailed Implementation

[0067] This disclosure generally provides additive manufacturing systems and methods for medical devices, such as catheters and leads, providing one or more splines extending from the outer surface of the medical device. The one or more splines can be configured in a variety of different ways depending on their application. For example, the one or more splines can be formed of materials different from or the same as the rest of the medical device. Furthermore, for example, each spline (or a portion of each spline) can be made of one or more materials. Specifically, different or the same materials can define various properties (e.g., hardness). Further, for example, the one or more splines can include bioabsorbable or pharmaceutical materials. In one or more embodiments, the one or more splines can include hydrophilic materials to aid in the propulsion of the medical device within a patient's body.

[0068] One or more splines can be formed on a medical device using additive manufacturing techniques, such as 3D printing. Additive manufacturing techniques can allow one or more splines to be formed on a medical device, such that the one or more splines include the properties and features described herein (e.g., different materials, configurations, etc.).

[0069] For example, the base element of a medical device (e.g., a catheter sheath) and one or more splines extending or protruding from the base element may comprise (e.g., formed therefrom) various materials that are the same as or different from each other. Furthermore, a portion of the base element may be made of the same or different material from another portion of the base element. Similarly, a portion of one or more splines may be made of the same or different material from another portion of one or more splines. Therefore, a medical device (e.g., including one or more splines) can be customized or optimized for a specific application based on the properties of the materials used to form one or both of the base element and the splines.

[0070] Specifically, in one embodiment, the material forming the base element can be defined as having a different hardness than the material forming one or more splines. In other words, different portions of the base element and splines can be defined as softer (e.g., rigid-elastic) or harder (e.g., less flexible) materials. Therefore, the material of the base element can define properties required by specific anatomical requirements (e.g., maneuverability, flexibility, torque transmission, etc.), while the material of the splines can define properties for use with the propulsion shaft or for anchoring it in specific body tissues. Thus, the characteristics of the device can be specifically tailored for a particular application.

[0071] In one or more embodiments, the medical device may include segments of alternative materials (e.g., with different properties) produced by additive manufacturing techniques. For example, the medical device may alternate between relatively soft and relatively hard segments. Specifically, a base element and one or more splines, or both, may have their materials replaced in subsequent segments. For example, when one or more splines are formed of a single material, the base element may have its materials replaced at segmented segments. Furthermore, for example, the base element may be a single material, while one or more splines replace materials at segmented segments. Further still, for example, both the base element and one or more splines may have their materials replaced at segmented segments (e.g., such that the materials of the base element and one or more splines are consistent in the same location). In one or more embodiments, the segmented segments may be defined along a helical path. These segments (e.g., oriented in a “zebra stripe pattern”) can help increase shaft flexural strength while allowing stiffer splines to transmit torque.

[0072] As used herein, the term “or” is an inclusive definition, for example, meaning “and / or”, unless the context of its use explicitly 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.

[0073] As used in this article, the phrases “at least one” and “one or more” followed by a list of elements refer to one or more of any of the listed elements, or any combination of the listed elements.

[0074] As used herein, the terms “coupled” or “connected” refer to at least two elements that are directly or indirectly attached to each other. Indirect coupling may include one or more other elements between the at least two attached elements. Both terms may be modified by “operatively” and “operably”, which are used interchangeably to describe a coupling or connection configured to allow components to interact to perform the stated or other known functions. For example, a controller may be operatively coupled to a resistance heating element to allow the controller to supply current to the heating element.

[0075] As used herein, any terms relating to position or orientation, such as “proximal,” “distal,” “end,” “external,” “internal,” etc., refer to relative positions and do not limit the absolute orientation of the implementation unless the context of their use clearly indicates otherwise.

[0076] Unless otherwise stated, all scientific and technical terms used herein have the meanings commonly used in the art. The definitions provided herein are for ease of understanding of certain terms frequently used herein and are not intended to limit the scope of this disclosure.

[0077] The aspects described in this disclosure will now be depicted with reference to the accompanying drawings. However, it should be understood that other aspects not depicted in the drawings also 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 numerals to designate elements in a given drawing is not intended to limit elements labeled with the same reference numerals in another drawing. Furthermore, the use of different reference numerals to designate elements in different drawings is not intended to indicate that elements referenced differently cannot be the same or similar.

[0078] Figure 1 An embodiment of an elongated implantable medical device or apparatus 100 is shown, comprising a base element 110 (e.g., a catheter sheath) having at least one spline 130 projecting therefrom. The base element 110 may define the basic structure of the device 100 and may extend along a longitudinal direction 101 (e.g., the path or axis along which the base element 110 extends) between a distal end 104 and a proximal end 102. It should be noted that the longitudinal direction 101 may extend along a path that curves in two or three dimensions (e.g., forming the medical device 100 along the same path), but... Figure 1 The image shows the device extending along a straight longitudinal axis. The base element 110 can define any suitable shape and size and can include any suitable components for forming the desired medical device 100 (e.g., electrical components, conductive materials, markers, steering elements such as traction cords or pullwire termination bands, structural elements, release mechanisms, etc.). For example, in one or more embodiments, electrical components may include sensors (e.g., pressure sensors), antennas, inductors, infrared diodes, diode lasers, laser waveguides, shunts, etc. Furthermore, markers may include, for example, radiopaque materials (e.g., metals and nonmetals, platinum, tantalum, tungsten, barium sulfate, bismuth, etc.) or RLC circuits forming harmonic oscillators that can be tuned to an MRI scanner as beacons for image-guided treatment. In one or more embodiments, structural elements may include braids or coils, and the release mechanism may include surgical sutures or ultra-high molecular weight polyethylene fibers (DSM). The base element 110 may define a lumen 115 or an elongated opening therein (e.g., extending longitudinally 101 within the base element 110), for example, as... Figure 2A-2B The cross-sectional view shown is illustrated. Lumen 115 can be configured as those known in catheter technology.

[0079] The base element 110 may include (e.g., be formed therefrom) any suitable material. For example, in one or more embodiments, the base element 110 may include a polymeric material. Specifically, the base element 110 may include thermoplastic materials, thermosetting polymeric materials, thermoplastic polyurethanes, nylon, nylon copolymers (e.g., Arkema). It may include block copolymers, including rigid polyamide blocks and soft polyether blocks, polyethylene terephthalate, polybutylene terephthalate, polyvinylidene fluoride, and thermoplastic elastomers. Butyl rubber (e.g., a copolymer of isobutylene and isoprene), high-density polyethylene, silicone, polyimide, conductive polymers (e.g., polyethylene dioxythiophene (PEDOT), poly(3,4-ethylenedioxythiophene), or thermoplastics with high carbon black content), or combinations thereof. In one or more embodiments, nylon may include, for example, polyamide, PA-12, PA-6, PA-6 / 6, with or without fillers, and nylon may be reinforced with glass fiber, glass beads, and carbon fiber to improve its mechanical and thermal properties.

[0080] In one or more embodiments, the device 100 may further include a support element 120 positioned or located within the lumen 115 of the base element 110 to provide a structure on which the base element 110 can be positioned or constructed. The support element 120 may also be described as providing axial reinforcement during use to, for example, transmit torque of the device 100. The support element 120 may extend longitudinally 101 between a distal end 104 and a proximal end 102. The support element 120 may be optional and... Figure 2A-2B The image is shown in dashed lines. In one or more embodiments, the support element 120 may include a liner, (e.g., braided) wire, polymer filaments, or any other type of reinforcement. In one or more embodiments, the liner may include PTFE, HDPE, PVDF, and / or Furthermore, the liner may use a lubricating coating comprising silicone oil and / or reactive silicone lubricants. Additionally, in one or more embodiments, the braided wire may comprise type 304 stainless steel with elastic tempering, which may be optimized for a specific application. Furthermore, for example, polymer filaments may define a higher melt temperature than the base element 110 and may be braided or coiled to reinforce the shaft. Furthermore, in one or more embodiments, the support element 120 may comprise hybrid metal / fabric braided coils, such as those described in U.S. Patent No. 10,080,862 entitled “TUBULAR BODIES FOR MEDICAL DELIVERY DEVICES AND RELATED MANUFACTURING METHODS,” which is incorporated herein by reference. In such embodiments where the device 100 defines a lumen, the lumen 115 may be defined within the support element 120. In one or more embodiments, the support element 120 may be permanent (e.g., included in the resulting device 100) or may be removable (e.g., after the formation of the device 100).

[0081] The device 100 may also include at least one spline 130 projecting from the outer surface 111 of the base element 110. The at least one spline 130 may be located at least near the distal end 104 of the base element 110. The at least one spline 130 may assist in advancing the medical device or apparatus 100 within the patient and / or temporarily or permanently anchoring the medical device 100. The at least one spline 130 may extend along the base element 110 for any suitable length. For example, the at least one spline 130 may extend a distance along the longitudinal axis 101, through which the device 100 may exit an access catheter, backup catheter, or catheter sheath. In one or more embodiments, the length of the at least one spline 130 extending along the longitudinal axis 101 may be determined to limit the amount of friction that may occur between the at least one spline 130 and the tissue during implantation (e.g., to prevent inhibition of catheter or lead advancement).

[0082] like Figure 1As shown, at least one spline 130 may extend along longitudinal direction 101 between proximal end 102 and distal end 104. In other embodiments, at least one spline 130 may extend along the distal portion or length of base element 110 (e.g., only near distal end 104). The distance by which at least one spline 130 extends from distal end 104 may be, for example, greater than or equal to about 0.125 inches (e.g., 0.3175 cm), greater than or equal to about 0.1875 inches (e.g., 0.47625 cm), greater than or equal to about 0.250 inches (e.g., 0.635 cm), etc., and / or less than or equal to about 2.50 inches (e.g., 6.35 cm), less than or equal to about 1.5 inches (e.g., 3.81 cm), less than or equal to about 1.00 inch (e.g., 2.54 cm), etc. Furthermore, the distance by which at least one spline 130 extends from the distal end 104 may be a ratio of the spline length (e.g., along the longitudinal axis) to the diameter of the base element 110. In one or more embodiments, the spline 130 may define a shorter length for the diameter of the base element 110, for example, approximately 3-7 Fr (French scale), and the spline 130 may define a longer length for the diameter of the base element 110, for example, approximately 7-30 Fr. In one or more embodiments, the distance by which at least one spline 130 extends from the distal end 104 may be a percentage of the total length of the medical device 100, for example, approximately 0.5% for septal venous pacing leads or CRT pacing leads, approximately 3% for long interventional catheters, septal venous lead delivery catheters or CRT lead delivery catheters, or approximately 25% for extravascular ICD lead delivery catheters. In yet another embodiment, at least one spline 130 may extend along the base element 110 in discrete segments between the proximal end 102 and the distal end 104.

[0083] The length of at least one spline 130 can vary depending on the intended use, resulting in a variety of desired ratios of spline length to base element diameter. For example, this ratio can be variable, resulting in an envelope on a graph depicting the longitudinal length of the spline and the diameter of the base element. Specifically, in some applications, the device 100 may traverse various sharp turns; therefore, at least one spline 130 may include multiple spline segments along the longitudinal direction (e.g., compared to a single, longer spline segment starting from the distal end 104) to provide improved performance upon reaching the target location within the anatomical structure. The spline can also generate friction as it engages tissue within the anatomical structure, friction that can be overcome to allow the spline to rotate forward. In these embodiments, multiple spline segments can help “pull” the conduit delivery system along different longitudinal locations along the axis. Therefore, the material segments of the spline can help reduce friction, thus maintaining a balance between the coefficient of friction, spline height, and pitch. Furthermore, a lubricating coating (e.g., a hydrophilic coating) can help optimize friction.

[0084] In one or more embodiments, at least one spline 130 may only partially cover the outer surface 111 of the base element 110. For example, as Figure 2B As shown in the cross-sectional view, at least one spline 130 may protrude from the base element 110 at different radial positions, such that the base element 110 (e.g., outer surface 111) is exposed to the external environment between each spline of the at least one spline 130.

[0085] In other embodiments, at least one spline may include a spline layer 131 covering the base element 110. For example, as Figure 2A As shown in the cross-sectional view, the spline layer 131 may extend between each spline of at least one spline 130 (e.g., such that the base element 110 is not exposed to the external environment at the location of the spline layer 131). Depending on the manufacturing process of the medical device 100, the spline layer 131 may be present between the splines 130 (e.g., Figure 2A (as shown), or spline layer 131 may not exist between splines 130 (e.g., Figure 2B (As shown). For example, if the spline material is the same as or similar to the base element material, spline layer 131 may not be present (e.g., as shown). Figure 2B (as shown in the diagram). Furthermore, for example, for polymers with poor miscibility, device 100 may include a spline layer 131, for example, having some type of surface treatment or adhesive layer (e.g., as shown in the diagram). Figure 2A (As shown).

[0086] Medical device 100 can be manufactured in any suitable manner. For example, base element 110 can be constructed using additive manufacturing as described in U.S. Patent No. 62 / 927,092 entitled “Additive Manufacturing for Medical Devices,” which is incorporated herein by reference. Furthermore, at least one spline 130 can be similarly manufactured using additive processes. Specifically, in one or more embodiments, base element 110 and at least one spline 130 can be formed during a single pass of a heated cylinder, which heats one or more filament materials and shapes the materials into the desired shape (e.g., base element 110 and at least one spline 130). In other embodiments, base element 110 can be formed during a first pass of the heated cylinder, and at least one spline 130 can be formed during a second pass of the heated cylinder (e.g., base element 110 is not moved or manipulated before the second pass), which can be described as a setup process. In one or more embodiments, the heated cylinder can include an extrusion die with a static or dynamic profile that shapes the filament material into the desired catheter sheath profile.

[0087] Furthermore, in one or more embodiments, the conduit segment on which splines 130 are formed can be extruded with a larger outer diameter and then laser-ablated to form splines, cross-splines, etc., protruding from the same base outer diameter as the non-spline segment (e.g., base element 110). Additionally, for example, when forming cross-splines (e.g., as... Figure 9 As shown, a fused deposition modeling nozzle with a radially shaped groove can be used to rapidly form individual spline segments. In one or more embodiments, an impression roller (e.g., including a semi-circular notch) can be used to displace still-molten filament material to form splines, cross splines, etc. Furthermore, in one or more embodiments, a cutting blade can be used to displace still-molten (or semi-molten) filament material to form cross splines, individual splines, etc.

[0088] At least one spline 130 can extend along any suitable path along the longitudinal direction 101. For example, as Figure 1 As shown, at least one spline 130 extends along a helical path on the base element 110. In other words, at least one spline 130 can helically or rotate around the base element 110 while traversing the base element 110 along the longitudinal direction 101. At least one spline 130 can define any suitable pitch (e.g., the distance between each coil of the spline) along the longitudinal direction 101. Specifically, the pitch of at least one spline 130 can depend on the application of the instrument 100. In one or more embodiments, the pitch of at least one spline 130 can depend on the diameter of the base element 110. For example, the pitch of at least one spline 130 can be approximately one to three times the diameter of the base element 110. In one or more embodiments, at least one spline 130 can extend parallel to the longitudinal direction 101 or asymmetrically along the instrument 100.

[0089] At least one spline 130 may include any number (e.g., multiple) of splines (e.g., portions of consecutive splines). For example, as Figure 2A and 2B As shown, at least one spline 130 includes four splines. The splines 130 may be spaced apart around the apparatus 100 in any suitable manner (e.g., such that the splines 130 are equidistant from each other, such that the splines 130 have different distances from each other, such that the splines 130 have at least one different distance from each other, etc.).

[0090] At least one spline 130 may comprise (e.g., formed therefrom) any suitable material. For example, in one or more embodiments, at least one spline 130 may comprise a polymeric material. Specifically, at least one spline 130 may comprise a thermoplastic material, a thermosetting polymeric material, a bioabsorbable material, a steroid, a hydrophilic coating, a heparin coating (e.g., for managing average setting time), or a combination thereof.

[0091] It can be described that the base material 110 includes (e.g., formed therefrom) a first material, and at least one spline 130 includes (e.g., formed therefrom) a second material, wherein the first material is different from the second material. In one or more embodiments, the first material (of the base element 110) may define a first Shore hardness that is different from the second Shore hardness of the second material (of at least one spline 130). For example, the first material may define a first Shore hardness that is smaller (e.g., softer) than the second Shore hardness of the second material. Thus, the base element 110 may be softer than at least one spline 130 (e.g., such that the base element 110 defines suitable characteristics for maneuverability, flexibility, and / or torque transmission, and at least one spline 130 defines suitable characteristics for propulsion and / or anchoring). Furthermore, in one or more embodiments, the first material may define a first Shore hardness that is larger (e.g., harder) than the second Shore hardness of the second material.

[0092] In one or more embodiments, the material forming the base element 110 and at least one spline 130, or both, may comprise a bioabsorbable material. In one or more embodiments, the material forming the base element 110 and at least one spline 130, or both, may comprise a steroid material. In one or more embodiments, the material forming the base element 110 and at least one spline 130, or both, may comprise a drug and a polymer. In one or more embodiments, the material forming the base element 110 and at least one spline 130, or both, may comprise a drug contained in a porous silica material. For example, at least one spline 130 may comprise a specific pharmaceutical silicone composition, allowing the drug to be released into surrounding tissue in a controlled manner.

[0093] Each of these additive materials can be arranged on the device 100 in any suitable manner. For example, the medical device 100 can be constructed using additive manufacturing as described in U.S. Patent No. 62 / 927,092 entitled “Additive Manufacturing for Medical Devices,” which is incorporated herein by reference. Thus, additive materials (e.g., bioabsorbable materials, steroid materials, pharmaceuticals, etc.) can be printed on the medical device 100, for example, by pixel-by-pixel 3D printing, using multiple printheads, or through multilayer processes.

[0094] Bioresorbable materials can be used on the splines of the cannula tip of a cardiac pacing lead with a helical spline to provide additional fixation with the active fixation lead, which can facilitate deeper insertion of the lead into the myocardium or anchoring the lead deep within a coronary vein (e.g., a septal vein). The cannula tip can be a molded polyurethane component located between the distal cathode and anode rings. Bioresorbable materials can be incorporated into the helical fixation spline, for example, to facilitate lead removability. Segments of the helical spline, which can be described as intermittent helical splines or “pieces,” can include (e.g., formed from) bioresorbable materials to increase fixation during implantation. The bioresorbable helical spline material can include steroids, and the cannula tip can also include steroids integrated (e.g., 3D printed) into the cannula tip itself to form an integrated monolithic controlled-release device (MCRD).

[0095] Specifically, in one or more embodiments, at least one spline 130 comprising the steroid material may comprise porous silica, which may be impregnated with dexamethasone acetate and may be referred to as a monolithic controlled-release device (MCRD). In other embodiments, at least one spline 130 may comprise porous polyurethane and other steroids, such as dexamethasone sodium phosphate and beclomethasone. These configurations can elute steroids for years along an exponentially decaying elution profile. Furthermore, the porous support material may be retained even when elution is not measurable (e.g., after elution has been completely removed from the support).

[0096] like Figure 3-5 As shown, medical device 200 may include segments or portions of materials that replace or change materials. Medical device 200 may include components related to... Figure 1 -2 illustrates the same components and features as described in the medical device 100. For example, the medical device 200 may include a base element 210 extending longitudinally 201 between a distal end 204 and a proximal end 202, and the base element 210 may define a lumen therein. Furthermore, with Figure 1 Similar to the medical device 100 shown in -2, the medical device 200 may include at least one spline 230 protruding from (e.g., at least near the distal end 204) the outer surface 211 of the base element 210.

[0097] The replacement material for medical device 200 can be manufactured in any suitable manner. For example, medical device 100 can be constructed using additive manufacturing as described in U.S. Patent No. 62 / 927,092 entitled “Additive Manufacturing for Medical Devices,” which is incorporated herein by reference. Specifically, the replacement material can be formed by pixel-by-pixel 3D printing using multiple printheads.

[0098] In addition, such as Figure 3As shown, the medical device 200 may include multiple portions of a spline 230, which defines and comprises different materials. For example, at least one spline 230 may include a first longitudinal segment 232 (e.g., comprising a first material) extending along the longitudinal direction 201 and a second longitudinal segment 234 (e.g., comprising a second material) extending along the longitudinal direction 201. The first longitudinal segment 232 may be adjacent to or near the second longitudinal segment 234 (e.g., such that the second longitudinal segment 234 is immediately before or after the first longitudinal segment 232 along the longitudinal direction 201). In one or more embodiments, the first material (of the first longitudinal segment 232) may be different from the second material (of the second longitudinal segment 234). Therefore, the characteristics of the first longitudinal segment 232 may be different from those of the second longitudinal segment 234. For example, the first material may define a first Shore hardness that is different from the second material's second Shore hardness. The different hardnesses of adjacent portions of at least one spline 230 may provide characteristics of the device 200 tailored to a specific application.

[0099] For example, the device 200 can be customized for specific bends (e.g., kinks) and torque transmission. Specifically, in some applications, alternating patterns using rigid and soft polymers can, for example, help better track anatomical structures, provide increased torque transmission (compared to soft polymers alone at the distal end), and avoid overstretching when pulling the catheter through tortuous anatomical structures. Furthermore, the alternation pattern can be gradient or a more discrete transition. For example, a rigid / soft continuous helical spline may have sufficient flexibility because the soft segment can manage abrupt changes in vessel shape and orientation while the rigid segment of the spline maintains continuous engagement with the vessel wall, thereby transmitting torque to irregularly shaped vessel walls. Additionally, alternating rigid / soft helical splines can transmit more force to the vessel wall through very localized engagement (e.g., the integration of those small but optimized engagements pulls the catheter through tortuous sections as it rotates forward).

[0100] In addition, such as Figure 4As shown, medical device 200 may include multiple portions of base element 210 defined and made of different materials. For example, base element 210 may include a first portion 212 extending along longitudinal direction 201 and may include (e.g., formed therefrom) a first material. Base element 210 may also include a second portion 214 extending along longitudinal direction 201 and may include (e.g., formed therefrom) a second material. In one or more embodiments, the first material (of the first portion 212) may be different from the second material (of the second portion 214). Therefore, the properties of the first portion 212 may differ from those of the second portion 214. For example, the first material may define a first Shore hardness different from the second material's second Shore hardness. The different hardnesses of adjacent portions of base element 210 may facilitate bending and torque transmission. In one or more embodiments, continuous helical splines may be more useful in continuous smooth blood vessels. In one or more embodiments, at least one spline 230 may include (e.g., formed therefrom) a third material different from the first and second materials.

[0101] In one or more implementations, for example Figure 5 As shown, both the base element 210 and at least one spline 230 can be made of different or different materials. For example, the first longitudinal segment 232 can correspond to or align with the first portion 212, and the second longitudinal segment 234 can correspond to or align with the second portion 214. Both the first longitudinal segment 232 and the first portion 212 can comprise a first material (e.g., formed of a first material), and both the second longitudinal segment 234 and the second portion 214 can comprise a second material (e.g., formed of a second material). As described herein, using different materials can facilitate bending and torque transmission.

[0102] Figure 6Another embodiment of the alternative or variable material of the medical device 300 is illustrated. Specifically, the base element 310 may include a first helical base portion 312 extending along a helical path and a second helical base portion 314 extending along the helical path adjacent to or only adjacent to the first helical base portion 312. The first helical base portion 312 may include a first material (e.g., formed of a first material), and the second helical base portion 314 may include a second material (e.g., formed of a second material). Furthermore, at least one spline 330 may include a first spline 332 that includes (e.g., formed of) the first material and protrudes from the first helical base portion 312. Additionally, in one or more embodiments, at least one spline 330 may include a second spline 334 that includes (e.g., formed of) the second material and protrudes from the second helical base portion 314. Alternative materials (e.g., alternative materials with different hardness) may provide the medical device 100 with improved bending and torque transmission (e.g., more continuous bending characteristics along a given helical portion). Furthermore, loading one spline with a steroid or hydrophilic material but not the other spline can help define the properties of each spline. Additionally, in one or more embodiments, one spline may be conductive (e.g., loaded with carbon black) and more tissue-conforming, while the other spline is more structural and used to anchor the electrically active helical spline to the blood vessel by rotating the tip of the advancing instrument.

[0103] By changing one or both of the materials forming the base elements 210, 310 and the materials forming at least one spline 230, 330, the instruments 200, 300 can be customized for a specific application. For example, the materials forming the instruments 200, 300 can define a specific torque-to-bending ratio for a particular application (e.g., rigid to apply sufficient torque, but flexible to navigate a tortuous path for that application).

[0104] like Figures 7A-7C As shown, the medical device 400 may include various recesses or channels that facilitate fluid flow through the medical device 400. The medical device 400 may include components related to... Figure 1 -2 illustrates the same components and features as described in the medical device 100. For example, the medical device 400 may include a base element 410 extending longitudinally 401 between a distal and proximal end, and the base element 410 may define a lumen 415 therein. Furthermore, with Figure 1 Similar to the medical device 100 shown in -2, the medical device 400 may include at least one spline 430 protruding from (e.g., at least near the distal end) the outer surface 411 of the base element 410.

[0105] also, Figure 7AAt least one spline 430 is shown defining a fluid flow channel 435 extending between splines 430. In other words, the fluid flow channel 435 may be defined between two separate splines 430 and the outer surface 411 of the base element 410. The fluid flow channel 435 may extend along a longitudinal direction 401. At least one spline 430 may be configured to protect the fluid flow channel 435 from tissue intrusion (e.g., from the patient's body) when the device 400 is implanted. Specifically, due to the tortuous path through which the medical device 400 may be implanted, having a dedicated fluid flow path that allows fluid to pass through (e.g., to maintain proper hydration) and can be designed to limit kinks or blockages.

[0106] Furthermore, the fluid flow channel 435 can be configured based on the specific treatment performed by the medical device 400 or the anatomical structures that the medical device 400 needs to traverse. For example, one particular therapy may include traversing the ventricular septum, and another particular therapy may involve advancing a delivery catheter into the coronary venous system through tortuous branches, which become smaller as the delivery catheter is advanced deeper.

[0107] In one or more embodiments, at least one spline 430 may be configured to deflect toward the outer surface 411 of the base element 410 when the device 400 is implanted, for example, as Figure 7B As shown by arrow 449. At least one spline 430 can be deflected such that the surface 436 of at least one spline 430 defines a fluid flow channel 435 between at least one spline 430 and the outer surface 411 of the base element 410 (e.g., causing at least one spline 430 to "tent").

[0108] In one or more embodiments, at least one spline 430 may define an outermost surface 438 (e.g., in the radial direction), and the fluid flow channel 435 may be defined by a groove in the outermost surface 438, for example, as Figure 7C As shown. In one or more embodiments, the hydrophilic material can be disposed at any suitable location on at least one spline 430 to facilitate fluid flow (e.g., within a fluid flow channel 435). For example, the hydrophilic material can comprise discrete layers, such as within, adjacent to, stacked, coated, etc., of the fluid flow channel 435, and partially fill the fluid flow channel. Specifically, the hydrophilic material can be disposed in a groove of at least one spline 430, on the outermost surface 438 of at least one spline 430, and / or on the surface 436 of at least one spline 430.

[0109] In one or more embodiments, the fluid flow channel 435 may have an extended surface to increase adhesion sites, or the fluid flow channel 435 may incorporate a matrix to help retain cross-linked hydrogels or hydrophilic materials within the fluid flow channel 435 (e.g., to increase the durability of the hydrophilic coating). Furthermore, ozone, corona, or plasma surface pretreatments may be used to improve covalent bonding with the substrate. Some hydrophilic coatings may be cured using ultraviolet light after surface deposition. Durability may be improved or the hydrophilic material may be attached to a hydrophobic substrate material by printing an adhesive layer material miscible with both the substrate and the hydrophilic material prior to hydrophilic coating deposition. In one or more embodiments, two types of hydrophilic materials may be printed on a surface (e.g., on the surface of the fluid flow channel 435), with one hydrophilic material printed on a first surface of the fluid flow channel 435 and another hydrophilic material printed on a second surface of the fluid flow channel 435 different from the first surface. The hydrophilic material in the fluid flow channel 435 may expand more, and fluid may be provided at high contact stress locations to flow to a more durable hydrophilic material that does not expand as much.

[0110] like Figure 8A As shown, medical device 500 can be configured to expand to assist in the movement of medical device 500 or in a specific procedure. Medical device 500 may include components related to... Figure 1 -2 illustrates the same components and features as described in the medical device 100. For example, the medical device 500 may include a base element 510 extending longitudinally 501 between a distal and proximal end, and the base element 510 may define a lumen 515 therein. Furthermore, with Figure 1 Similar to the medical device 100 shown in -2, the medical device 500 may include at least one spline 530 protruding from (e.g., at least near the distal end) the outer surface 511 of the base element 510.

[0111] At least one spline 530 may define a spline lumen 540 extending through at least one spline 530. Furthermore, at least one spline 530 may comprise a flexible material (e.g., flexible relative to the rest of the device 500) such that at least one spline 530 may be expandable (e.g., when fluid is inserted into the spline lumen 540). In one or more embodiments, at least one spline 530 may comprise a first portion 542 formed of a first material and a second portion 544 formed of a second material. The second portion 544 may be disposed radially distal to the first portion 542 (e.g., outside or outside the first portion). The first material may define a first Shore hardness, and the second material may define a second Shore hardness less than the first Shore hardness. Thus, when fluid is inserted into the spline lumen 540, the outermost material of at least one spline 530 (e.g., the second portion 544) may allow at least one spline 530 to expand. In other embodiments, the first and second materials may be formed of the same flexible material.

[0112] At least one spline 530 can be manufactured to be expandable in any suitable manner. For example, the medical device 500 can be constructed using additive manufacturing as described in U.S. Patent No. 62 / 927,092 entitled “Additive Manufacturing for Medical Devices,” which is incorporated herein by reference, and at least one spline 530 may include further processing. For example, in one or more embodiments, a thin wall of a highly elastic material (e.g., a biocompatible elastomer) can be extruded onto a mandrel (e.g., made of copper). For each spline of at least one spline 530, the biocompatible elastomer can be longitudinally positioned via an extruder. The biocompatible elastomer can then be moved by die cutting for at least one spline 530 or by a die without cuts (e.g., without splines). During the second passage, a second material (e.g., if the proximal and intermediate portions are not expandable) can be placed or formed thereon and transformed into a biocompatible elastomer for the expandable portion of at least one spline 530 (e.g., the balloon portion of at least one spline 530). The mandrel can then be stretched and pulled out from the middle of at least one spline 530 to form a lumen. A mold can then be inserted at the distal end to close the lumen of at least one spline 530. Furthermore, the mold can be inserted into a hub to form an expansion manifold in fluid communication with the lumen (e.g., thus using a Luer connector to attach an inflator or syringe).

[0113] In another embodiment, at least one expandable spline 530 can be manufactured using pixel-by-pixel 3D printing. In such an embodiment, at least one spline 530 may include post-printing curing, a sealant, or an adhesive. Furthermore, if at least one expandable spline 530 is created by multiple passes, an adhesive layer with potentially different pixel sizes (e.g., different shooting sizes) can be used.

[0114] Furthermore, in one or more embodiments, the base element 510 may include a flexible material such that the base element 510 is expandable (e.g., the device 500 may not include a support element, such as a braided layer or a support element of a reinforcement beneath the base element 510 at an expandable portion). In such embodiments, at least one spline 530 may be formed of a flexible material such that at least one spline is expandable (e.g., when the base element 510 expands).

[0115] Expandable spline 530 (e.g., as Figure 8A (As shown) This can help provide perfusion while dilating and / or anchoring blood vessels or anatomical structures, because the expandable spline 530 may not obstruct the vessel (e.g., compared to a conventional expandable catheter balloon). Furthermore, the expandable spline 530 can allow for non-invasive rotational advancement by advancing with the helical spline 530 compressed one turn, expanding and dilating at rest, and repeating this process. In addition, variations of this incremental advancement of the catheter or lead may exist and can be applied to advance the catheter or lead in conditions where it is not in a blood vessel (e.g., the ventricular septum).

[0116] For example, such as Figure 8B As shown, in one or more embodiments, a splined lumen 540 (e.g., shown in dashed lines) may extend from a proximal end 502 to a distal end 504. Each splined lumen 540 may extend to a circular manifold shared with the proximal end 102 of the expandable helical splined lumen 540. Furthermore, the splined lumen 540 may transition from the base element 510 to each spline 530.

[0117] In addition, for example, such as Figure 8C and 8D As shown in one or more embodiments, the device 500 may define a tubular filament spline 530 that may be wound around the base element 510. For example, the tubular filament spline 530 may conform to surrounding body tissue (e.g., in use) and may be more non-invasive than a fully solid or “filled” spline. The spline 530 may be positioned on and coupled to the outer surface 511 of the base element 510 (e.g., as shown in the figure). Figure 8C (as shown), or it can be partially or completely embedded within the base element 510 (e.g., as shown). Figure 8D(As shown). Furthermore, if spline 530 is made of an elastic material (e.g., as described herein), spline 530 can expand by extending through a lumen 540 therethrough (e.g., an unembedded portion of spline 530 can expand and extend from the base element 510). In one or more embodiments, as described herein, a removable mandrel / wire 541 can be inserted into the lumen 540 during its formation or manufacture (and, for example, removed from it after manufacturing and before use). In such embodiments, the mandrel / wire 541 may comprise filaments or monofilaments, such as ultra-high molecular weight polyethylene (UHMWPE, e.g., manufactured by Dutch State Mines). ), polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), etc. Specifically, mandrel / wire 541 may define low coefficient of friction fibers (e.g., UHMWPE), may not have the rigidity of typical mandrels used for polymer processing (e.g., flexibility during disassembly to facilitate navigation of helical splines), and / or may include multi-strand stranded cables.

[0118] It should be noted that, Figure 8C The embodiments illustrated can be manufactured using a process that involves extruding a variant of parallel tubing (i.e., side-by-side tubing). Paratubing involves arranging two conventional extruders and outputting material in parallel (and, for example, defining lumens through which each passes). However, typical parallel tubing manufacturing processes may not be suitable for winding around large lumens (e.g., defining a base element) or for extrusion with smaller helices (e.g., defining a tubular spline). Therefore, the process described herein provides a process for manufacturing an apparatus 500 that can define, as Figure 8C The spiral or tubular filament spline 530 shown is wound around the base element 510.

[0119] like Figure 9-11 As shown, medical device 600 may include a plurality of splines extending along paths that intersect or cross on outer surface 611. Medical device 600 may include components related to... Figure 1 -2 shows the same components and features as those described in the medical device 100. For example, the medical device 600 may include a base element 610 extending longitudinally 601 between a distal end 604 and a proximal end 602, and the base element 610 may define a lumen therein. Furthermore, with Figure 1 Similar to the medical device 100 shown in -2, the medical device 600 may include at least one spline 630 protruding from (e.g., at least near the distal end 604) the outer surface 611 of the base element 610.

[0120] At least one spline 630 may include a first spline 652 extending along a first helical path and a second spline 654 extending along a second helical path. The second helical path may be defined to extend in a rotational direction opposite to the first helical path, such that the paths of the first spline 652 and the second spline 654 intersect. In one embodiment, the first and second splines 652 and 654 may contact and intersect.

[0121] However, in another embodiment, the first and second splines 652 and 654 do not physically contact each other, but the paths extending on the first and second splines 652 and 654 intersect each other. Therefore, in this embodiment, the first spline 652 can be described as continuous, while the second spline 654 can be described as discontinuous or segmented.

[0122] In one or more embodiments, the first spline 652 may protrude radially from the outer surface 611 by a first distance 653, which is greater than the second distance 655 from the outer surface 611 of the second spline 654 (e.g., as shown in the figure). Figure 10 (As shown).

[0123] In one or more embodiments, the first spline 652 may be configured to aid in controlling the movement of the instrument 600, and the second spline 654 may be flexible in one direction and restrict specific movement, as further described herein. For example, the second spline 654 may protrude from the outer surface 611 at an angle toward the proximal end 602. Thus, when the medical instrument 600 (e.g., the distal end 604) is inserted into a patient, the second spline 654 may deflect toward the outer surface 611. However, when the medical instrument 600 moves in the opposite direction (e.g., toward the proximal end 602), the second spline 654 may engage tissue in which the instrument 600 is positioned, for example, to restrict movement.

[0124] Each of the first and second splines 652, 654 may comprise the same or different materials. For example, the first spline 652 may comprise (e.g., formed therefrom) a first material, and the second spline 654 may comprise (e.g., formed therefrom) a second material. In one or more embodiments, the first material may define a first Shore hardness that is less than the second Shore hardness of the second material.

[0125] Including cross-helical splines (e.g., as Figure 9-11 The medical device shown can be constructed in a variety of different ways. For example, a cross-helical spline can be generated using multiple additional steps, such as 3D printing a cross-helical spline on a base element, or obtaining material from a first spline to generate a second cross-helical spline. For example, as... Figure 12AAs shown, the first spline 652 can protrude from the outer surface 611 and define a dome shape. Furthermore, in the process of a tool extracting material from the first spline 652 to produce or form the second spline 654, the second spline 654 can define a shape at an angle, such as... Figure 12B As shown.

[0126] Specifically Figure 14 An embodiment of a method 800 for additive manufacturing an implantable medical catheter with a cross-helical spline is shown. For example, method 800 may include feeding a substrate 802 through a substrate channel in a heating cylinder. The substrate channel may be in fluid communication with the inner cavity of the heating cylinder. Furthermore, the method may include feeding at least a first filament through a filament port into the inner cavity 804 and melting the first filament 806 in the inner cavity. The method may then include moving the heating cylinder 808 relative to the substrate at least in a longitudinal and a first rotational direction to form a catheter sheath and a first spline projecting from the outer surface of the catheter sheath, the first spline comprising material from the first filament. In other words, melting the first filament 806 can provide material to form the catheter sheath and the spline, and moving the heating cylinder 808 relative to the substrate can form the catheter sheath and the spline. By moving the heating cylinder in the rotational direction, the first spline can extend along a first helical path consistent with the rotational direction.

[0127] The method may further include moving the funnel element 810 relative to the substrate at least longitudinally and in a second rotational direction opposite to the first rotational direction to form a second spline projecting from the outer surface of the catheter sheath, the second spline comprising material from the first spline. In other words, the funnel element can be moved relative to the catheter sheath to "smear" the first material from the first spline to form the second spline. The second spline can extend along a second helical path extending in a rotational direction opposite to the first helical path, such that the first spline and the second spline intersect.

[0128] For example, Figure 15 An embodiment is shown in which a cross-helical spline extending along the outer surface 911 of the medical device 900 protrudes along a plane. Specifically, Figure 15An initial first spline 952 is shown, which can be formed along an outer surface 911 using a shaped extrusion die that extends continuously along the outer surface 911. A second spline 954 can be formed by displacing a portion of the molten filament material of the initial first spline 952. Specifically, a funnel die 990 can be moved laterally to the initial first spline 952 such that the funnel die 990 collects molten filament material from the initial first spline, which deposits a section of filament material to form the intersecting second spline 954. Thereafter, only a portion of the initial first spline 952 can be retained, resulting in a discontinuous first spline 953 (e.g., because a portion is used to form the second spline 954). After forming each of the first and second splines 953, 954, the filament material can be hardened or solidified. It should be noted that... Figure 15 Multiple funnel molds 990 are shown, but any suitable number of funnel molds 990 can be used.

[0129] like Figure 13 As shown, medical device 700 may include at least one spline 730 having or defining a textured surface. Medical device 700 may include components that are compatible with... Figure 1 -2 illustrates the same components and features as described in the medical device 100. For example, the medical device 700 may include a base element 710 extending longitudinally 701 between a distal and proximal end, and the base element 710 may define a lumen 715 therein. Furthermore, with Figure 1 Similar to the medical device 100 shown in -2, the medical device 700 may include at least one spline 730 protruding from (e.g., at least near the distal end) the outer surface 711 of the base element 710.

[0130] Furthermore, at least one spline 730 may define a textured outermost surface 738 to facilitate implantation of the medical device 700. For example, in one or more embodiments, the textured outermost surface 738 may define a plurality of recesses. Furthermore, in one or more embodiments, the textured outermost surface 738 may define crosshairs. Furthermore, in one or more embodiments, the textured outermost surface 738 may define a plurality of microgrooves or microsplines. It should be noted that, although... Figure 13 Only the outermost textured surface 738 is shown, but any surface of at least one spline 730 (e.g., a side surface) can define the textured surface.

[0131] Illustrative Implementation

[0132] While this disclosure is not limited thereto, an understanding of various aspects of this disclosure will be gained through the discussion of the specific embodiments and illustrative implementations provided below. Various modifications to the embodiments and illustrative implementations, as well as additional implementations of this disclosure, will become apparent herein.

[0133] A1. An apparatus comprising:

[0134] A base element extending longitudinally between a distal and a proximal end, wherein the base element comprises a first material, and wherein the base element defines a lumen therein; and

[0135] At least one spline protrudes from the outer surface of the base element at least near the distal end, partially covering only the outer surface, wherein the at least one spline comprises a second material, wherein the first material defines a first Shore hardness that is different from the second material's second Shore hardness.

[0136] A2. The apparatus of embodiment A1, wherein the at least one spline extends along a helical path on the outer surface of the base element.

[0137] A3. The apparatus of embodiment A1 or A2, wherein the at least one spline comprises a plurality of splines extending along the longitudinal direction.

[0138] A4. Any device described in the preceding embodiment A, wherein the base element includes at least one of braided thread and inner lining.

[0139] B1. An apparatus comprising:

[0140] A base element extending longitudinally between a distal and a proximal end, wherein the base element comprises a first material, and wherein the base element defines a lumen therein; and

[0141] At least one spline protrudes from the outer surface of the base element at least near the distal end, wherein the at least one spline comprises a second material, wherein the second material comprises a bioabsorbable material.

[0142] B2. The device described in embodiment B1, wherein the second material comprises a steroid material.

[0143] B3. The device described in embodiment B1 or B2, wherein the second material comprises a drug and a polymer.

[0144] B4. Any device described in the preceding embodiment B, wherein the second material comprises a drug in a porous silicone material.

[0145] C1. An apparatus comprising:

[0146] A base element extending longitudinally between a distal and a proximal end, wherein the base element comprises a first material, and wherein the base element defines a lumen therein; and

[0147] At least one spline protrudes from the outer surface of the base element at least near the distal end, wherein the at least one spline comprises a second material, wherein the second material comprises a steroid material.

[0148] D1. An apparatus comprising:

[0149] A base element extending longitudinally between a distal and a proximal end, wherein the base element defines a lumen therein; and

[0150] At least one spline protrudes from the outer surface of the base element at least near the distal end, wherein the at least one spline includes a first longitudinal segment comprising a first material extending along the longitudinal direction and a second longitudinal segment comprising a second material extending along the longitudinal direction, wherein the first longitudinal segment is close to or adjacent to the second longitudinal segment.

[0151] D2. The apparatus of embodiment D1, wherein the at least one spline extends along a helical path on the outer surface of the base element.

[0152] D3. The apparatus of embodiment D1 or D2, wherein the at least one spline comprises a plurality of splines extending longitudinally.

[0153] D4. Any device described in the preceding embodiment D, wherein the first material defines a first Shore hardness that is different from the second material's second Shore hardness.

[0154] E1. An apparatus comprising:

[0155] A base element extending longitudinally between a distal and a proximal end, wherein the base element includes a first portion comprising a first material extending along the longitudinal direction, and a second portion comprising a second material extending along the longitudinal direction, wherein the first portion extends proximally to or adjacent to the second portion, wherein the base element defines a lumen therein; and

[0156] At least one spline protrudes from at least one outer surface of the first and second portions, at least near the distal end.

[0157] E2. The apparatus according to embodiment E1, wherein the at least one spline extends along a helical path on the outer surface of the base element.

[0158] E3. An apparatus according to embodiment E1 or E2, wherein the at least one spline comprises a plurality of splines extending longitudinally.

[0159] E4. Any device described in the preceding embodiment E, wherein the first material defines a first Shore hardness that is different from the second material's second Shore hardness.

[0160] E5. Any device according to the preceding embodiment E, wherein the at least one spline comprises: a first spline comprising the first material and projecting from the outer surface of the first portion; and optionally a second spline comprising the second material and projecting from the outer surface of the second portion.

[0161] E6. Any device described in the preceding embodiment E, wherein the first portion and the second portion extend along a helical path.

[0162] E7. Any device described in the preceding embodiment E, wherein the at least one spline comprises a third material different from the first and second materials.

[0163] F1. An apparatus comprising:

[0164] A base element extending longitudinally between a distal and a proximal end, wherein the base element defines a lumen therein; and

[0165] At least one spline protrudes from the outer surface of the base element at least near the distal end, wherein the at least one spline defines a fluid flow channel extending along the longitudinal direction, wherein the at least one spline is configured to prevent tissue intrusion into the fluid flow channel during implantation of the device.

[0166] F2. The device of embodiment F1, wherein the at least one spline is configured to deflect toward the outer surface of the base element when the device is implanted, such that the surface of the at least one spline defines the fluid flow channel between the at least one spline and the outer surface of the base element.

[0167] F3. The apparatus of embodiment F1 or F2, wherein the at least one spline defines an outermost surface in the radial direction, and the fluid flow channel is defined by a groove in the outermost surface.

[0168] F4. The device described in embodiment F3 further includes a hydrophilic material disposed in a groove of at least one spline.

[0169] F5. Any device described in the preceding embodiment F, further comprising a hydrophilic material disposed on the at least one spline.

[0170] G1. An apparatus comprising:

[0171] A base element extending longitudinally between a distal and a proximal end, wherein the base element defines a lumen therein; and

[0172] At least one spline protrudes from the outer surface of the base element at least near the distal end, wherein the at least one spline defines a spline lumen extending through the at least one spline, wherein the at least one spline comprises a flexible material such that the at least one spline is expandable.

[0173] G2. The apparatus of embodiment G1, wherein the at least one spline comprises a first portion and a second portion, the first portion comprising a first material defining a first Shore hardness, the second portion comprising a flexible material defining a second Shore hardness less than the first Shore hardness, wherein the second portion is disposed radially distal to the first portion.

[0174] G3. The device described in embodiment G1 or G2, wherein the base element comprises a first material defining a first Shore hardness, and the flexible material defining a second Shore hardness less than the first Shore hardness.

[0175] H1. An apparatus comprising:

[0176] A base element extending longitudinally between a distal and a proximal end, wherein the base element defines a lumen therein, wherein the base element comprises a flexible material such that the base element is expandable; and

[0177] At least one spline protrudes from the outer surface of the base element at least near the distal end, wherein the at least one spline comprises a flexible material such that the at least one spline is expandable.

[0178] 11. An apparatus comprising:

[0179] A base element extending longitudinally between a distal and a proximal end, wherein the base element defines a lumen therein; and

[0180] At least one spline protrudes from the outer surface of the base element at least near the distal end, wherein the at least one spline comprises a first spline extending along a first helical path and a second spline extending along a second helical path extending in a direction of rotation opposite to the first helical path, such that the first spline and the second spline intersect.

[0181] I2. The apparatus of embodiment I1, wherein the first spline protrudes radially from the outer surface by a first distance, the first distance being greater than the second spline protruding from the outer surface by a second distance.

[0182] I3. The device according to embodiment I1 or I2, wherein the second spline protrudes from the outer surface in a direction toward the proximal end.

[0183] I4. Any device according to the preceding embodiment I, wherein the first spline comprises a first material and the second spline comprises a second material, the first material defining a first Shore hardness less than the second Shore hardness of the second material.

[0184] J1. A method comprising:

[0185] The substrate is fed through a substrate channel in the heating cylinder, and the substrate channel is in fluid communication with the inner cavity of the heating cylinder;

[0186] At least a first filament is fed into the inner cavity through the filament port;

[0187] The first filament is melted within the inner cavity;

[0188] The heating cylinder is moved relative to the substrate at least in the longitudinal and first rotational directions to form a conduit sheath and a first spline protruding from the outer surface of the conduit sheath, the first spline comprising material from the first filament, wherein the first spline extends along a first helical path; and

[0189] The funnel element is moved relative to the substrate at least in the longitudinal direction and in a second rotational direction opposite to the first rotational direction to form a second spline protruding from the outer surface of the conduit sheath, wherein the spline comprises material from the first spline, and the second spline extends along a second helical path with a rotational direction opposite to the first helical path, such that the first spline and the second spline intersect.

[0190] K1. An apparatus comprising:

[0191] A base element extending longitudinally between a distal and a proximal end, wherein the base element defines a lumen therein; and

[0192] At least one spline protrudes from the outer surface of the base element at least near the distal end, wherein the at least one spline defines a textured outermost surface for easy implantation.

[0193] K2. The device described in embodiment K1, wherein the textured outermost surface defines a plurality of pits.

[0194] K3. The apparatus described in embodiment K1 or K2, wherein the textured outermost surface defines intersecting ray linings.

[0195] K4. Any device described in the preceding K embodiments, wherein the textured outermost surface defines a plurality of microgrooves.

[0196] Therefore, various embodiments of the medical device are disclosed, including at least one spline extending longitudinally from the outer surface of the device and a method for manufacturing the spline. It should be understood that the aspects disclosed herein can be combined in different combinations than those specifically presented in the specification and drawings. It should also be understood that, according to embodiments, certain actions or events of any process or method described herein may be performed in a different order, may be added, combined, or completely omitted (e.g., all described actions or events may not be necessary for implementing the technology). Furthermore, although some aspects of this disclosure are described for clarity as being performed by a single module or unit, it should be understood that the technology of this disclosure can be performed by a combination of units or modules associated with, for example, a medical device.

[0197] In one or more embodiments, the described techniques can be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functionality can be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. The computer-readable medium can include non-transitory computer-readable media, which corresponds to tangible media such as data storage media (e.g., random access memory, read-only memory, electrically erasable programmable read-only memory, 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).

[0198] 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 in this disclosure can refer to any of the foregoing structures or any other physical structure suitable for implementing the technology. Furthermore, the technology can be fully implemented in one or more circuit or logic elements.

[0199] For all purposes, all references and publications cited in this disclosure are expressly incorporated herein by reference unless in any way directly contradicts this disclosure.

[0200] Unless otherwise stated, all figures used in the specification and claims that represent feature dimensions, quantities, and physical properties are to be understood as being modified by the terms “precise” or “about”. Therefore, unless otherwise stated, the numerical parameters shown in the foregoing specification and appended claims are approximations that may vary depending on the teachings disclosed herein or, for example, the desired properties sought to be obtained within typical ranges of experimental error.

[0201] As used herein, the term “configured as” may be used interchangeably with the terms “adapted to” or “structured into”, unless otherwise clearly stated in this disclosure.

[0202] The singular forms “a”, “an”, and “the” cover implementations with plural indicators unless the context clearly indicates otherwise.

[0203] As used in this article, "have," "having," "include," "including," "comprise," and "comprising" are all used in their open-ended sense and generally mean "including but not limited to." It should be understood that phrases such as "consisting essentially of" and "consisting of" are categorized under "included."

[0204] The terms "one embodiment," "an embodiment," "certain embodiments," or "some embodiments" refer to specific features, configurations, compositions, or characteristics described in connection with an embodiment, which are included in at least one embodiment of this disclosure. Therefore, the appearance of these phrases in various places throughout the text does not necessarily refer to the same embodiment of this disclosure. Furthermore, specific features, configurations, compositions, or characteristics may be combined in any suitable manner in one or more embodiments.

[0205] 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. A medical device comprising: A base element extending longitudinally between a distal end and a proximal end, wherein the base element defines a lumen therein; and At least one spline, formed as a single continuous element, protrudes from the outer surface of the base element at least near the distal end, wherein the at least one spline varies in material composition along the longitudinal direction, transitioning from a first material to a second material, wherein the first material defines a first Shore hardness that is different from the second material's second Shore hardness.

2. The medical device according to claim 1, wherein, The at least one spline extends along a helical path on the outer surface of the base element.

3. The medical device according to claim 1 or 2, wherein, The at least one spline includes a plurality of splines extending along the longitudinal direction.

4. The medical device according to claim 1, wherein, At least one of the first material and the second material includes a bioabsorbable material.

5. The medical device according to claim 1, wherein, At least one of the first material and the second material includes a steroid material.

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