Systems and methods for manufacturing 3D printed medical devices

Systems and methods for manufacturing an elongate medical device including various surface features. The system including a heating cartridge, a heating element, a filament handling system, a substrate handling system, a controller, and one or more additional components adapted to form the surface features on the medical device. The heating element melts a filament material within the heating cartridge to form a jacket of the medical device and the one or more additional components engages the outer surface of the jacket to create surface features.

SUMMARY

The techniques of the present disclosure generally relate to additive manufacturing of medical devices, such as catheters and leads, that allows for further customization of the medical devices. For example, the systems and techniques described herein may allow for integrating features quickly, iterating designs, and designing new geometries and features in a more specific manner. Specifically, the shape and/or size of the medical device or features disposed thereon may be readily manufactured to the operators specifications. Therefore, the unique characteristics of a patient's vasculature may be accounted for when designing and manufacturing the medical device.

DETAILED DESCRIPTION

The present disclosure generally provides additive manufacturing systems and methods for medical devices, such as catheters and leads, that allows for customization of the medical device. Additive manufacturing may also be described as three-dimensional (3D) printing. By using an additive manufacturing process, a wider variety of hardness levels can be achieved compared to existing techniques to produce catheters, catheter components, or implantable devices. Further, the additive manufacturing process allows for various tooling and processes to design and develop specific medical device features (that may be difficult to otherwise make). For example, the system may operate similar to a polymer printer and polymer lathe to create and refine any particular medical device. As such, new designs and new dimensions may be created in an efficient way.

Specifically, designing the shape and dimensions of the medical device may be beneficial in customizing the medical device for a particular application. For example, a particular design/shape may be more specific to one patient as compared to another. Therefore, externally added three-dimensional surface protrusions (such as, e.g., threads, splines, nubs, or similar) may aid in the performance of the medical device by modifying the friction of interface surfaces between the medical device body and the anatomy of the patient. For example, in one or more embodiments, the surface features may provide anchoring mechanisms for screwing or threading the medical device into an annularity/cylindrical anatomical feature, or to create preferred performance characteristics (e.g., bending, straightening, torque, etc.). In other words, the medical device may be easily altered using the tooling and methods described herein to define further features of the medical device.

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

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

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

As used herein, any term related to position or orientation, such as “proximal,” “distal,” “end,” “outer,” “inner,” and the like, refers to a relative position and does not limit the absolute orientation of an embodiment unless its context of usage clearly dictates otherwise.

Reference will now be made to the drawings, which depict one or more aspects described in this disclosure. However, it will be understood that other aspects not depicted in the drawings fall within the scope of this disclosure. Like numbers used in the figures refer to like components, steps, and the like. However, it will be understood that the use of a reference character to refer to an element in a given figure is not intended to limit the element in another figure labeled with the same reference character. In addition, the use of different reference characters to refer to elements in different figures is not intended to indicate that the differently referenced elements cannot be the same or similar.

FIG.1shows one example of an additive manufacturing system100according to the present disclosure. The system100may be configured and used to produce a catheter, catheter component, lead, or subassembly. The system100may use or include consumable filament materials or pellet form resins having a wide variety of hardness levels. The system100may be configured to operate a wide variety of process conditions to produce catheters, catheter components, leads, or subassemblies using filaments or pellet form resins of various hardness levels. In general, the system100defines a distal region128, or distal end, and a proximal region130, or proximal end. The system100may include a platform124including a rigid frame to support one or more components of the system.

Further components of the system100may be shown as described in U.S. Pat. App. No. 62/927,092, entitled “ADDITIVE MANUFACTUING FOR MEDICAL DEVICES,” which is herein incorporated by reference. For example, as shown in the illustrated embodiment, the system100may include one or more components, such as a heating cartridge102, a heating element104, a filament handling system106, an optional wire handling system107, a substrate handling system108, a controller110, and a user interface112. The filament handling system106may be operably coupled to the heating cartridge102. The filament handling system106may provide one or more filaments114to the heating cartridge102. The optional wire handling system107may be used to provide one or more wires115to the heating cartridge102. The heating element104may be operably coupled, or thermally coupled, to the heating cartridge102. The heating element104may provide heat to melt filament material in the heating cartridge102from the one or more filaments114provided by the filament handling system106. The optional wires115may not be melted by the heating cartridge102. The substrate handling system108may be operably coupled to the heating cartridge102. The substrate handling system108may provide a substrate116that extends through the heating cartridge. Melted filament material located in the heating cartridge102may be applied to the substrate116. The substrate116or the heating cartridge102may be translated or rotated relative to one another by the substrate handling system108. The substrate handling system108may be used to move the substrate116or the heating cartridge102relative to one another to cover the substrate116with the melted filament material to form a jacket118. The optional wires115may be incorporated into the jacket118(e.g., molded into, bedded within, etc.).

The substrate116may also be described as a mandrel or rod. The jacket118may be formed or deposited around the substrate116. In some embodiments, the jacket118may be formed concentrically around the substrate116. In one example, the jacket118is formed concentrically and centered around the substrate116.

When the system100is used to make a catheter or catheter component, the jacket118may be described as a catheter jacket. Some or all of the substrate116may be removed or separated from the jacket118and the remaining structure coupled to the jacket may form the catheter or catheter component, such as a sheath. One example of a catheter that may be formed by the system100is shown inFIG.6.

The substrate116may be formed of any suitable material capable of allowing melted filament material to be formed thereon. In some embodiments, the substrate116is formed of a material that melts at a higher temperature than any of the filaments114. One example of a material that may be used to form the substrate116includes stainless steel.

The controller110may be operably coupled to one or more of the heating element104, the filament handling system106, the substrate handling system108, and the user interface112. The controller110may activate, or initiate or otherwise “turn on,” the heating element104to provide heat to the heating cartridge102to melt the filament material located therein. Further, the controller110may control or command one or more motors or actuators of various portions of the system100. Furthermore, the controller110may control one or more motors or actuators the filament handling system106to provide one or more filaments114. Further, the controller110may control one or more motors or actuators of the substrate handling system108to move one or both of the heating cartridge102or the substrate116relative to one another. Further still, the controller110may send or receive data to the user interface112, for example, to display information or to receive user commands. Control of the components operably coupled to the controller110may be determined based on user commands received by the user interface112. In some embodiments, the user commands may be provided in the form of a machine-readable code or coding language.

Any suitable implementation may be used to provide the substrate handling system108. In some embodiments, the substrate handling system108may include one or more of a head stock120, an optional tail stock122, and one or more motors coupled to or included in the head stock or tail stock. One or both of the head stock120and the tail stock122may be coupled to the platform124. A stock may be defined as a structure that holds or secures the substrate116during formation of the jacket118. The head stock120is defined as the stock closest to the end of the substrate116where formation of the jacket118begins in the formation process. In the illustrated embodiment, the jacket118is shown proximal to the head stock120and distal to the heating cartridge102.

When the substrate116is secured by one or both stocks120,122, the substrate is generally positioned to pass through a substrate channel defined by the heating cartridge102. One or both stocks120,122may include a clamp or other securing mechanism to selectively hold the substrate116. Such a clamp may be operably coupled to a substrate motor. In some embodiments, the substrate motor may be used to control opening and closing of the clamp. In some embodiments, the substrate motor may be used to rotate the substrate116in a clockwise or counterclockwise direction about a longitudinal axis126. A translation motor may be operably coupled between a stock120,122and the platform124. In some embodiments, the translation motor may be used to translate the stock120,122in a longitudinal direction along the longitudinal axis126. In some embodiments, the translation motor also may be used to translate the stock120,122in a lateral direction different than the longitudinal axis126. The lateral direction may be oriented substantially orthogonal, or perpendicular, to the longitudinal axis126.

In some embodiments, the substrate handling system108may be configured to move the head stock120at least in a longitudinal direction (for example, parallel to the longitudinal axis126) relative to the platform124. The substrate116may be fed through the substrate channel of the heating cartridge102by movement of the head stock120relative to the platform124. A distal portion of the substrate116may be clamped into the head stock120. The head stock120may be positioned close to the heating cartridge102at the beginning of the jacket formation process. The head stock120may move distally away from the heating cartridge102, for example in a direction parallel to the longitudinal axis126. In other words, the head stock120may move toward the distal region128of the system100while pulling the secured substrate116through the heating cartridge102. As the substrate116passes through the heating cartridge102, melted filament material from the filament114may be formed or deposited onto the substrate116to form the jacket118. The heating cartridge102may be stationary relative to the platform124. In some embodiments, the tail stock122may be omitted.

In some embodiments, the substrate handling system108may be configured to move the heating cartridge102at least in a longitudinal direction (along the longitudinal axis126) relative to the platform124. The substrate116may be fed through the substrate channel of the heating cartridge102. A distal portion of the substrate116may be clamped into the head stock120. A proximal portion of the substrate116may be clamped into the tail stock122. In one example, the heating cartridge102may be positioned relatively close to the head stock120at the beginning of the jacket formation process. The heating cartridge102may move proximally away from the head stock120. The heating cartridge102may move toward the proximal region130of the system100. As the heating cartridge102passes over the substrate116, melted filament material may be deposited onto the substrate116to form a jacket. The head stock120and the tail stock122may be stationary relative to the platform124. In another example, the heating cartridge102may start near the tail stock122and move toward the distal region128.

One or more motors of the substrate handling system108may be used to rotate one or both of the substrate116and the heating cartridge102relative to one another. In some embodiments, only the substrate116may be rotated about the longitudinal axis126. In some embodiments, only the heating cartridge102may be rotated about the longitudinal axis126. In some embodiments, both the substrate116and the heating cartridge102may be rotated about the longitudinal axis126.

The heating cartridge102may be part of a subassembly132. The subassembly132may be coupled to the platform124. In some embodiments, one or more motors of the substrate handling system108may be coupled between subassembly132and the platform124to translate or rotate the subassembly132, including the heating cartridge102, relative to the platform124or the substrate116. In some embodiments, one or more motors of the substrate handling system108may be coupled between a frame of the subassembly132and the heating cartridge102to translate or rotate the heating cartridge relative to the platform124.

In some embodiments, the substrate116may be rotated about the longitudinal axis126relative to the heating cartridge102to facilitate forming certain structures of the jacket. In one example, the substrate116may be rotated by one or both of the head stock120and the tail stock122of the substrate handling system108. In another example, the heating cartridge102or subassembly132may be rotated by the substrate handling system108.

The system100may include one or more concentricity guides134. The concentricity guide134may facilitate adjustments to the concentricity of the jacket around the substrate116before or after the substrate passes through the heating cartridge102. The concentricity guide134may be longitudinally spaced from the heating cartridge102. In some embodiments, the spacing may be greater than or equal to 1, 2, 3, 4, or 5 cm. The spacing may be sufficient to allow the jacket118to cool down and no longer be deformable. In some embodiments, one or more concentricity guides134may be positioned distal to the heating cartridge102and to engage the jacket118. In some embodiments, one or more concentricity guides134may be positioned proximal to the heating cartridge102to engage the substrate116. The concentricity guide134may mitigate drooping of the substrate116and may mitigate susceptibility to eccentricity in the alignment of the stock120,122and the heating cartridge102.

Any suitable implementation may be used to provide the filament handling system106. One or more filaments114may be loaded into the filament handling system106. For example, filaments114may be provided in the form of wound coils. Filaments114may be fed to the heating cartridge102by the filament handling system106. In some embodiments, the filament handling system106may include one, two, or more pinch rollers to engage the one or more filaments114. In some embodiments, the filament handling system106may include one or more motors. The one or more motors may be coupled to the one or more pinch rollers to control rotation of the pinch rollers. The force exerted by the motors onto the pinch rollers and thus onto the one or more filaments114may be controlled by the controller110.

In some embodiments, the filament handling system106may be configured to feed the filaments114including at least a first filament and a second filament. The jacket118may be formed from the material of one or both of the filaments114. The filament handling system106may be capable of selectively feeding the first filament and the second filament. For example, one motor may feed the first filament and another motor may feed the second filament. Each of the motors may be independently controlled by the controller110. Selective, or independent, control of the feeds may allow for the same or different feed forces to be applied to each of the filaments114.

The filaments114may be made of any suitable material, such as polyethylene, PEBAX elastomer (commercially available from Arkema S. A. of Colombes, France), nylon 12, polyurethane, polyester, liquid silicone rubber (LSR), or PTFE.

The filaments114may have any suitable Shore durometer. In some embodiments, the filaments114may have, or define, a Shore durometer suitable for use in a catheter. In some embodiments, the filaments114have a Shore durometer of at least 25A and up to 90A. In some embodiments, the filaments114have a Shore durometer of at least 25D and up to 80D.

In some embodiments, the filament handling system106may provide a soft filament as one of the filaments114. In some embodiments, a soft filament may have a Shore durometer less than or equal to 90A, 80A, 70A, 80D, 72D, 70D, 60D, 50D, 40D, or 35D.

In some embodiments, the filament handling system106may provide a hard filament and a soft filament having a Shore durometer less than the soft filament. In some embodiments, the soft filament has a Shore durometer that is 10D, 20D, 30D, 35D, or 40D less than a Shore durometer of the hard filament.

The system100may be configured to provide a jacket118between the Shore durometers of a hard filament and a soft filament. In some embodiments, the filament handling system106may provide a hard filament having a Shore durometer equal to 72D and a soft filament having a Shore durometer equal to 35D. The system100may be capable of providing a jacket118having a Shore durometer that is equal to or greater than 35D and less than or equal to 72D.

The system100may be configured to provide a jacket118having, or defining, segments with different Shore durometers. In some embodiments, the system100may be capable of providing a jacket118having one or more of a 35D segment, a 40D segment, 55D segment, and a 72D segment.

The filaments114may have any suitable width or diameter. In some embodiments, the filaments114have a width or diameter of 1.75 mm. In some embodiments, the filaments114have a width or diameter of less than or equal to 1.75, 1.5, 1.25, 1, 0.75, or 0.5 mm.

Segments may have uniform or non-uniform Shore durometers. The system100may be configured to provide jacket118having one or more segments with non-uniform Shore durometers. In some embodiments, the jacket118may include continuous transitions between at least two different Shore durometers, for example, as shown inFIG.6.

The controller110may be configured to change a feeding force applied to one or more of the filaments114to change a ratio of material in the jacket over a longitudinal distance. By varying the feeding force, the system100may provide different Shore durometer segments in a jacket118, whether uniform or non-uniform. In one example, sharp transitions between uniform segments may be provided by stopping or slowing longitudinal movement while continuously, or discretely with a large step, changing the feeding force of one filament relative to another filament of the substrate116relative to the heating cartridge102. In another example, gradual transitions between segments may be provided by continuously, or discretely with small steps, changing the feeding force of one filament relative to another filament while longitudinally moving the substrate116relative to the heating cartridge102.

The one or more wires115provided by the wire handling system107may be introduced in any suitable manner. In some embodiments, the wires115may be attached to the substrate116and pulled by movement of the substrate. One example of a wire is a pull wire that may be used to steer the catheter produced by the system100. In some embodiments, a particularly shaped heating cartridge may be used to accommodate one or more wires115.

Any suitable type of heating element104may be used. In some embodiments, the heating element104may be a resistive-type heating element, which may provide heat in response to an electrical current. Other types of heating elements that may be used for the heating element104include a radio frequency (RF) or ultrasonic-type heating element. The heating element104may be capable of providing heat sufficient to melt the filaments114. In some embodiments, the heating element104may heat the filaments114to greater than or equal to 235, 240, 250, or 260 degrees Celsius. In general, the one or more heating elements104may be used to heat the filaments114to any suitable melting temperature known to one of ordinary skill in the art having the benefit of this disclosure.

FIG.2shows one example of an additive manufacturing apparatus200of the additive manufacturing system100in an end view along the longitudinal axis126, which is illustrated as a circle and cross. More detail of some components of the additive manufacturing system100are shown, such as the heating cartridge102and the filament handling system106.

The heating cartridge102may include a heating block202at least partially defining an interior volume204. The interior volume204may be heated by the heating element104. The heating element104may be thermally coupled to the heating block202to melt filament material in the interior volume204. In general, the system100may be configured to melt any portion of the filaments114in the interior volume204. The heating element104may be disposed in an exposed or exterior volume defined in the heating block202. The heating element104may be positioned proximate to or adjacent to the interior volume204. In some embodiments, one, two, three, or more heating elements104may be thermally coupled to the heating block202.

The heating block202may allow the substrate116, which may be an elongate substrate or member, to pass through the heating block. The substrate116may be able to extend, or pass, through the interior volume204. The substrate channel206defined by the heating cartridge102may extend through the interior volume204. The substrate channel206may extend in a same or similar direction as the substrate116. The substrate channel206may extend along the longitudinal axis126.

A width or diameter of the interior volume204is larger than a width or diameter of the substrate116. The width or diameter of the interior volume204or the substrate116is defined in a lateral direction, which may be orthogonal to the longitudinal axis126. In one example, the lateral direction may be defined along a lateral axis210. In some embodiments, the clearance between the substrate116and interior volume204is relatively small to facilitate changes in composition of filament material used to form the jacket118(FIG.1) around the substrate116.

The portion of the interior volume204around the substrate116may receive a flow of melted filament material from the filaments114. When more than one filament material is provided to the interior volume204, the filament materials may flow and blend, or mix, around the substrate116.

In the illustrated embodiment, the filaments114includes a first filament212and a second filament214. The first filament212may be provided into the interior volume204through a first filament port216at least partially defined by the heating block202. The second filament214may be provided into the interior volume204through a second filament port218at least partially defined by the heating block202. Each filament port216,218may be at least partially defined by the heating block202. Each filament port216,218may be in fluid communication with the interior volume204.

The filaments114may be delivered to the interior volume204in the same or different manners. In the illustrated embodiment, the first filament212is delivered to the interior volume204in a different manner than the second filament214.

The filament handling system106may include a first handling subassembly220. The first handling subassembly220may deliver the first filament212to the interior volume204. The first handling subassembly220may include one or more pinch rollers222. Each of the one or more pinch rollers222may be operably coupled to a motor. Any suitable number of pinch rollers222may be used. As illustrated, the first handling subassembly220may include two sets of pinch rollers222. Pinch rollers222may be used to apply a motive force to the first filament212to move the first filament, for example, toward the interior volume204.

The heating cartridge102may include a first guide sheath224. The first guide sheath224may extend between the filament handling system106and the interior volume204. The first guide sheath224may be coupled to the heating block202. The first guide sheath224may extend into the first filament port216from an exterior of the heating block202. The first guide sheath224may define a lumen in fluid communication with the interior volume204. An inner width or diameter of the lumen may be defined to be greater than a width or diameter of the first filament212. The first filament212may extend through the first guide sheath224from the pinch rollers222of the first handling subassembly220to the first filament port216and extend distally past the first guide sheath224into the interior volume204.

As used herein with respect to the filaments114, the term “distal” refers to a direction closer to the interior volume204and the term “proximal” refers to a direction closer to the filament handling system106.

In some embodiments, a proximal end of the first guide sheath224may terminate proximate to one of the pinch rollers222. A distal end of the first guide sheath224may terminate at a shoulder226defined by the first filament port216. A distal portion or distal end of the first guide sheath224may be positioned proximate to or adjacent to the interior volume204.

The inner width or diameter of the lumen of the first guide sheath224may be defined to be substantially the same or equal to an inner width or diameter of the first filament port216, such as a smallest inner width or diameter of the first filament port. In other words, an inner surface of the first guide sheath224may be flush with an inner surface of the first filament port216.

In some embodiments, the heating cartridge102may include a support element228. The support element228may be coupled to the first guide sheath224. The first guide sheath224may extend through a lumen defined by the support element228. The support element228may be proximate to the heating block202. In the illustrated embodiment, the support element228is coupled to the heating block202. The support element228may include a coupling protrusion configured to be mechanically coupled to a coupling receptacle230defined by the first filament port216. In some embodiments, the coupling receptacle230may define threads and the coupling protrusion of the support element228may define complementary threads.

The coupling receptacle230may terminate at the shoulder226of the first filament port216. The coupling protrusion of the support element228may be designed to terminate at the shoulder226. In some embodiments, a distal end of the support element228and the distal end of the first guide sheath224may engage the shoulder226. In other embodiments, the distal end of the support element228may engage the shoulder226and the distal end of the first guide sheath224may engage a second shoulder (not shown) defined by the first filament port216distal to the shoulder226.

When the first filament port216defines one shoulder, the first filament port216may define at least two different inner widths or diameters. The larger inner width or diameter may be sized to thread the support element228and the smaller inner width or diameter may be sized to match the inner width or diameter of the first guide sheath224.

When the second filament port218defines two shoulders, the first filament port216may define at least three different inner widths or diameters. The largest inner width or diameter may be sized to thread the support element228. The intermediate inner width or diameter may be sized to receive a distal portion of the first guide sheath224. The smallest inner width or diameter may be sized to match the inner width or diameter of the first guide sheath224.

The filament handling system106may include a second handling subassembly232. The second handling subassembly232may deliver the second filament214to the interior volume204. The second handling subassembly232may include one or more pinch rollers222. Each of the one or more pinch rollers222may be operably coupled to a motor. Any suitable number of pinch rollers222may be used. As illustrated, the second handling subassembly232may include one set of pinch rollers222. Pinch rollers222may be used to apply a motive force to the second filament214.

The heating cartridge102may include one or more of a second guide sheath234, a heat sink236, and a heat break238. The second guide sheath234may extend at least between the second handling subassembly232and the heat sink236. The second guide sheath234may be coupled to the heat sink. The second guide sheath234may be coupled to the second handling subassembly232. The heat sink236may be coupled to the heat break238. The heat break238may be coupled to the heat block202. The heat break238may extend into the second filament port218from an exterior of the heating block202.

The second guide sheath234may define a lumen in fluid communication with the interior volume204. The second filament214may extend through the second guide sheath234from the second handling subassembly232to the heat sink236, through the heat sink236, through the heat break, and through the second filament port218. In some embodiments, the second guide sheath234may extend to the pinch rollers22in the second handling subassembly232. In some embodiments, the second guide sheath234may extend at least partially into the heat sink236.

The heat break238may be proximate to the heating block202. The heat break238may be positioned between the heat sink236and the heating block202. The heat break238may include a coupling protrusion configured to mechanically couple to a coupling receptacle240defined by the second filament port218. In some embodiments, the coupling receptacle240may define threads and the coupling protrusion of the heat break238may define complementary threads. The second filament port218may include one or more shoulders such as those described with respect to the first filament port216, except that the second filament port218may not be configured to receive the second guide sheath234. The inner width or diameter of the support element228may be larger than the inner width or diameter of the heat break238, for example, to accommodate the outer width or diameter of the first guide sheath224. In other embodiments, the second filament port218may be configured to receive the second guide sheath234in a similar manner to the first filament port216receiving the first guide sheath224.

Any suitable material may be used to make the guide sheaths224,234. In some embodiments, one or both guide sheaths224,234may include a synthetic fluoropolymer. One or both guide sheaths224,234may include polytetrafluoroethylene (PTFE). Another suitable material may include an ultra-high molecular weight polyethylene (UHMWPE).

Any suitable material may be used to make the support element228. In some embodiments, the support element228may be a thermal insulator. The support element228may include a thermoplastic. The support element228may be made of a polyamide-imide, such as a TORLON polyamide-imide (commercially available from McMaster-Carr Supply Co. of Elmhurst, Ill.). Other suitable materials may include liquid-crystal polymer, polyaryletherketone (PAEK), polyphenylene sulfide, and polysulfone.

The support element228may provide mechanical support to the first guide sheath224. The support element228may include a substantially rigid material. In some embodiments, the support element228include a material having a higher durometer than material used to make the first guide sheath224.

Any suitable material may be used to make the heat sink236. The heat sink236may include a high thermal conductivity material. In some embodiments, the heat sink236includes aluminum.

Any suitable material may be used to make the heat break238. The heat break238may include a low thermal conductivity material. In some embodiments, the heat break238includes titanium. The heat break238may include a necked portion to reduce the amount of material between a proximal portion and a distal portion of the heat break. The necked portion may facilitate a reduced thermal conductivity between the proximal portion and the distal portion of the heat break238.

In general, use of the apparatus200may facilitate using softer filaments at high feed forces and pressures, which tend to compress the soft filament and may result in jamming. Using higher feed forces and pressures may allow for a greater range of process conditions and may provide a consistent jacket around the substrate. In particular, use of the first guide sheath224extending at least partially into the first filament port216may facilitate the use of softer filament and greater “push-ability.” Additionally, or alternatively, the use of the support element228may also facilitate the use of softer filament and greater “push-ability.” In other embodiments, the apparatus200may include a screw or static mixer to help push a softer filament. In other words, the screw or static mixer may provide a cavity for softer filament material to be moved forward between the threads of the screw.

FIG.3shows a partial cross-sectional side view of one example of the heating cartridge102. The heating cartridge102or the heating block202may extend from a proximal side410to a distal side412. In some embodiments, the heating cartridge102may include one or more of the heating block202, an inlet die402coupled to the proximal side410of the heating block, an outlet die404coupled to the distal side412of the heating block, a proximal retaining plate406to facilitate retaining the inlet die adjacent to the heating block, and a distal retaining plate408to facilitate retaining the outlet die adjacent to the heating block.

The inlet die402and the outlet die404may be retained in any suitable manner. In the illustrated embodiment, the outlet die404may be retained by a distal shoulder of the distal retaining plate408. In some embodiments, the inlet die402may be retained by the proximal retaining plate406between a distal shoulder of the proximal retaining plate406and a fastener, such as a nut with a lumen extending through, which may be threaded to the retaining plate to engage a proximal surface of the inlet die. The retaining plates406,408may be fastened to the heating block202in any suitable manner.

The inlet die402may at least partially define a substrate inlet port414. The outlet die404may at least partially define a substrate outlet port416. The inlet die402may at least partially define the interior volume204. The outlet die404may at least partially define the interior volume204. In some embodiments, an exterior surface of the inlet die402, an interior surface of the outlet die404, and an interior surface of the heating block202may cooperatively define the interior volume204.

The substrate channel206may be described as extending from the proximal side410to the distal side412of the heating cartridge102, or vice versa. The substrate channel206may extend through the interior volume204. As shown, the substrate channel206may extend through one or more of the proximal retaining plate406, the inlet die402, the heating block202, the outlet die404, and the distal retaining plate408.

FIG.4shows an end view of one example of an inlet or outlet die700that may be used in the heating cartridge102(FIG.1). The die700may define a substrate inlet or outlet port702. The port702may define a main region704and one, two, three, four, or more cutouts706, or cutout regions. In the illustrated embodiment, the port702defines four cutouts706.

When the interior cross-sectional shape die700is used in an outlet die, the jacket formed by the heating cartridge102may include a number of protrusions corresponding to the number of cutouts706used in the die700. For example, the illustrated die700would produce four protrusions on the jacket.

In some embodiments, one or more of the cutouts706may be sized to receive a wire115(FIG.1), such as a pull wire, which may be provided by the wire handling system107(FIG.1). In some embodiments, the interior cross-sectional shape of die700may be used in both the input die and the outlet die to accommodate the wires115pulled through the cutouts706.

FIG.5shows an end view one example of an inlet or outlet die720that may be used in the heating cartridge102(FIG.1). The die720may define a substrate inlet or outlet port722. The port722may define a main region724and one, two, three, four, or more protrusions726, or cutout regions. In the illustrated embodiment, the port722defines two protrusions726, or teeth.

When the interior cross-sectional shape die720is used in an outlet die, the jacket formed by the heating cartridge102may include a number of channels corresponding to the number of protrusions726used in the die720. For example, the illustrated die720would produce two channels on the jacket.

FIG.6shows one example of a catheter600that may be manufactured using the system100before the substrate116is removed. The substrate116may include a lubricious coating on its exterior surface to facilitate removal. The lubricious coating may extend around the circumference of the substrate116. One example of a lubricious coating is a PTFE coating.

The substrate116may be covered with a liner602, such as a PTFE layer. The liner602may be placed over the lubricious coating. The liner602may extend around the circumference of the substrate116.

The liner602may be covered with a braid604, such as a stainless-steel braid layer. The braid604may be placed over the liner602. The braid604may extend around the circumference of the liner602. The braid604may be porous.

The jacket118may be applied to the braid604. When the jacket118is formed, the liner602may adhere to the jacket118through pores in the braid604.

In the illustrated embodiments, the catheter600includes a first segment606, a second segment608, and a third segment610. Each segment606,608,610may have different durometers. In some embodiments, the first segment606may have a high durometer, the third segment610may have a low durometer, and the second segment608may have a continuously varying durometer in a longitudinal direction between the durometers of the first and third segments. For example, the first segment606may have a Shore durometer equal to 72D, the third segment610may have a Shore durometer equal to 35D, and the second segment608may have a Shore durometer that gradually changes from 72D to 35D over its length.

The jacket118produced by the system100may be altered and modified in a variety of different ways to provide specific features of the jacket118. For example, as shown inFIG.1, the system100may include an additional component101that operates to further process the jacket118to include various features. In one or more embodiments, the additional component101may be directly coupled to the heating cartridge102. In other embodiments, the additional component101may be spaced apart from the heating cartridge102along the longitudinal axis126. Whether the additional component101is directly attached or spaced apart from the heating cartridge102, the additional component101may be positioned distal to (e.g., trailing) the heating cartridge102such that the additional component101may alter or modify the jacket118after it is formed by the heating cartridge102.

In one or embodiments, the system100may be adapted to selectively adjust the substrate outlet to modify the size and/or shape of the substrate outlet. In other words, the substrate outlet may be blocked or obstructed to further refine the shape of the material defining the jacket118. Specifically, as shown inFIG.7, the system100may include a shutter510that defines an opening512that coincides with and is spaced longitudinally from the substrate outlet. The shutter510may include a body portion514and one or more fins516movably coupled to the body portion514such that the one or more fins516are 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 fins516may modify the opening such that the profile of the jacket118extending through the substrate outlet may be consequently altered. The shutter510as described herein may operate similar to a camera shutter or iris.

The shutter510may be configured to modify the jacket118in various different ways. For example, the shutter510may expand and retract to alter the thickness or cross-sectional diameter of the jacket118. Also, as shown inFIG.7, the one or more fins516of the shutter510may alter or modify cutouts706of the outlet die700such that the one or more fins516may modify the size and/or shape of the cutouts706(and, therefore, may alter the characteristics of the resultant protrusions on the jacket118). For example, the one or more fins516may be moved to alter the height of the cutouts706or remove the cutouts706altogether. In other words, the shutter510may be configured to toggle between creating a jacket with protrusions (e.g., when the fins are not blocking all or a portion of the cutouts) and a jacket without protrusions (e.g., when the fins are completely blocking the cutouts). Additionally, the shutter510may be configured to reduce the overall diameter of the outlet such that the resultant diameter of the jacket may be modified. Therefore, a varying output geometry (e.g., a tapered portion) may be defined on the jacket (e.g., proximate an end of the jacket) using the shutter510.

Each of the one or more fins516may extend between a first end region517movably coupled to the body portion514(e.g., pivotable via a pin) and a second end region518adapted to move relative to the substrate outlet. In other words, the second end region518of the fin516may be adapted to cover up or block (e.g., at least a portion) of the substrate outlet (e.g., to define features of the jacket). Further, the shutter510may include one or more linkages520, each linkage520corresponding to a fin of the one or more fins516. Each linkage520may extend between a first end region movably coupled to the body portion and a second end region movably coupled to the corresponding fin516(e.g., pivotable via a pin). In one or more embodiments, the body portion514may define one or more slots522within which each linkage520(e.g., the first end region) is movably coupled.

Further, the controller may be adapted to change these characteristics along the length of the jacket by changing the positions of the one or more fins516. In other words, the shutter510may be controllable to selectively position the one or more fins516relative to the substrate outlet and, thereby, affect the shape and/or size of the jacket. Therefore, when manufacturing the jacket, a user may specifically vary features of the jacket by controlling the shutter510. In other words, the shutter510may be able to turn features on and off at specific times and locations in the printing of the jacket. Further, the one or more fins516of the shutter510can change the shape of the opening to provide radial tapering or embed a shape into the jacket.

The shutter510may be positioned relative to the heating cartridge (e.g., the substrate outlet port) in any suitable way. For example, in one or more embodiments, the shutter510may be located distal to the substrate outlet port. In other embodiments, the shutter510may be located proximal to the substrate outlet port (e.g., between the outlet die and the inlet die). Additionally, in one or more embodiments, the shutter510may be directly attached to the heat cartridge (e.g., to the outlet die). In other embodiments, the shutter510may be spaced apart from the heating cartridge. In such embodiments, the shutter510may move along with the heating cartridge to post-process the jacket after the jacket is formed.

As shown inFIG.8, the system100may include one or more cutting tools530to engage the jacket118and define features therein. For example, the cutting tools530may act as a surface modification tool to slice and/or raise the surface of the jacket118into various shapes (e.g., similar to a lathe or CNC type tool that could be called and move as needed). In one or more embodiments, the one or more cutting tools530may be heated to melt/soften and form a portion of the jacket118with which the cutting tool engages. Each cutting tool of the one or more cutting tools530may include a cutting edge532oriented towards the longitudinal axis126and may be configured to selectively engage the jacket118. In other words, the cutting edge532of the cutting tool530may interact with the jacket530to remove material therefrom to define features on the surface of the jacket118. For example, the features defined in the surface of the jacket118may be used to create structures that may interface with specific geometries and anatomical features of the vascular or to provide spaces/channels for various components to be placed therein.

The cutting edge532of the one or more cutting tools530may be positioned between an edge of the substrate outlet and the longitudinal axis so as to position the cutting edge532proximate an outer surface of the jacket118(e.g., being formed through the substrate outlet). For example, the cutting edge532of the one or more cutting tools530may be configured to engage the jacket118from a shallow cut that may act as a surface finish, a deep cut that extends the full depth/thickness of the jacket118, or anywhere therebetween.

Each cutting tool of the one or more cutting tools530may extend between a base edge534and the cutting edge532along a cutting axis535. In one or more embodiments, the cutting axis535may be positioned at a downward angle relative to the longitudinal axis126between about 0 and 180 degrees. Preferably, the cutting axis535may be positioned at a downward angle relative to the longitudinal axis of 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.

Further, in one or more embodiments, the one or more cutting tools530may be movably coupled to the heating cartridge (e.g., at the base edge) or any other structure distal to the heating cartridge. As such, the one or more cutting tools530may be movable between an engaged position and a spaced apart position (e.g., pivoting between the positions). The cutting tool530(e.g., the cutting edge) may be in contact with the jacket118(e.g., so as to cut and define a portion of the jacket) when in the engaged position and not in contact with the jacket118when in the spaced apart position. In one or more embodiments, the movement may occur through pivoting the cutting tool530or moving the cutting tool530laterally into position. Further, in one or more embodiments, the one or more cutting tools530may be configured to move radially along the jacket118to a specific position.

The one or more cutting tools530may include any number of suitable cutting tools. For example, the one or more cutting tools530may include one, two, three, or four or more cutting tools. In one or more embodiments, the multiple cutting tools530may be configured to move independently from one another. It is noted that the controller may be configured to control the various movements of the one or more cutting tools530.

The one or more cutting tools530may be positioned relative to the heating cartridge (e.g., the substrate outlet port) in any suitable way. For example, in one or more embodiments, the one or more cutting tools530may be located distal to the substrate outlet port. In other embodiments, the one or more cutting tools530may be located proximal to the substrate outlet port (e.g., between the outlet die and the inlet die). Additionally, in one or more embodiments, the one or more cutting tools530may be directly attached to the heat cartridge (e.g., to the outlet die). In other embodiments, the one or more cutting tools530may be spaced apart from the heating cartridge. In such embodiments, the one or more cutting tools530may move along with the heating cartridge to post-process the jacket after the jacket is formed.

As shown inFIG.9, the system100may also include an additional guide sheath540configured to modify or alter the jacket118with an additional filament material542. For example, the additional guide sheath540may be positioned distal to the heating cartridge102(e.g., the outlet die) and may define an additional filament lumen544configured to receive the additional filament542. In one or more embodiments, the additional filament542may be fed through the additional guide sheath540using the filament handling system as described herein.

The additional guide sheath540may be configured to move to any portion along the jacket118to selectively deposit additional filament material542on the jacket118. For example, the additional guide sheath540may be configured to move relative to the jacket118(e.g., longitudinally or radially) using the controller. By depositing additional filament material542on the jacket118, various features may be formed to modify the characteristics of the jacket118. For example, petals or lobes may be formed on the surface of the jacket.

The additional filament542may include a same materials as the first filament114. In other words, the features defined by the additional filament542may be the same material as the material that forms the jacket118. In other embodiments, the additional filament542may include a different material than the first filament114. In other words, the features defined by the additional filament542may be a different material (e.g., including different properties) than the material that forms the jacket118.

The additional guide sheath540may be positioned relative to the heating cartridge (e.g., the substrate outlet port) in any suitable way. For example, in one or more embodiments, the additional guide sheath540may be located distal to the substrate outlet port. In other embodiments, the additional guide sheath540may be located proximal to the substrate outlet port (e.g., between the outlet die and the inlet die). Additionally, in one or more embodiments, the additional guide sheath540may be directly attached to the heat cartridge (e.g., to the outlet die). In other embodiments, the additional guide sheath540may be spaced apart from the heating cartridge. In such embodiments, the additional guide sheath540may move along with the heating cartridge to post-process the jacket after the jacket is formed.

In one or more embodiments, the system100may include one or more rolling wheels550as shown inFIG.10. The one or more rolling wheels550may be spaced longitudinally from the substrate outlet and engage an outer surface of the jacket118. For example, the rolling wheels550may act as a surface modification tool to form the surface of the jacket118that may still be deformable (e.g., soft) after being melted. Each rolling wheel of the one or more rolling wheels550may be configured to rotate about an axis551perpendicular to the longitudinal axis126. Further, the axis551of rotation for each rolling wheel of multiple rolling wheels550may be different and positioned along a circle concentric to the substrate outlet. In other words, each rolling wheel550may be oriented in a different plane and spaced around the jacket such that each rolling wheel is normal to the surface of the jacket118(e.g., an outer surface of the rolling wheel550may be tangential to the surface of the jacket118). The rolling wheels550may be held in place using along the circular axis551or using clips at a distal edge553of each roller wheel. Each rolling wheel may define an outer surface552that faces the longitudinal axis126such that the outer surface552of the rolling wheel550may contact the surface of the jacket118. Further, the outer surface552of the rolling wheel550may be configured to engage the jacket118to imprint features on the jacket118. In one or more embodiments, the outer surface552of the rolling wheel550may define a contour that follows the curved surface of the jacket118. Therefore, the entirety of the outer surface552of the rolling wheel550may contact the jacket118(e.g., to increase the amount of contact area).

The outer surface of the one or more rolling wheels550may define any suitable textured pattern. The textured pattern of the rolling wheel may be pressed against the jacket to imprint the inverse texture onto the jacket118. The textured pattern of the rolling wheel may form various features onto the jacket118such as, e.g., channels, protrusions, dimples, bumps, etc. Each of these features imprinted onto the jacket118may be desirable to achieve specific characteristics of the surface of the jacket118as described herein. Also, the one or more rolling wheels550may define any suitable width. For example, the one or more rolling wheels550may define a width of about 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 rolling wheel550may determine the amount of contact area between the rolling wheel550and the jacket118.

In one or more embodiments, the rolling wheels550may include a radial clamp such that the width of the rolling wheel550may be defined as a percentage of the circumference of the jacket118. In other words, the rolling wheels550may define a semi-circular shape at the outer surface552of the rolling wheel550that may be configured to engage a set amount of the jacket118. Multiple rolling wheels may combine to encircle the circumference of the jacket118and modify that portion of the jacket118. For example, in one embodiment, the system may include three rolling wheels that are positioned around the jacket118such that each rolling wheel550engages with ⅓ of the circumference of the jacket118.

Additionally, in one or more embodiments, the system may include more than one set of rolling wheels along the axis of the jacket118(e.g., similar to straightening wheels). In other embodiments, the rolling wheels550may be arranged to shape and define curves of the jacket within the system100(e.g., bending the jacket118out of the longitudinal axis126).

Further, in one or more embodiments, the controller may be configured to position the one or more rolling wheels550in an engaged position and a spaced apart position. For example, the one or more rolling wheels550may be configured to move towards (e.g., laterally) and in contact with the jacket118when in the engaged position and away from the jacket118when in the spaced apart position. The one or more rolling wheels550may move in any direction and orientation as is suitable to create a feature on the surface of the jacket118. For example, in one embodiment, the rolling wheels550may move rotationally about the longitudinal axis around the jacket118.

The one or more rolling wheels550may include any number of suitable rolling wheels. For example, the one or more rolling wheels550may include one, two, three, or four or more rolling wheels. In one or more embodiments, multiple rolling wheels550may be equally spaced apart. In other embodiments, multiple rolling wheels550may be adjacent to one another. In one or more embodiments, the multiple rolling wheels550may be configured to move independently from one another.

The one or more rolling wheels550may be positioned relative to the heating cartridge (e.g., the substrate outlet port) in any suitable way. For example, in one or more embodiments, the one or more rolling wheels550may be located distal to the substrate outlet port. In other embodiments, the one or more rolling wheels550may be located proximal to the substrate outlet port (e.g., between the outlet die and the inlet die). Additionally, in one or more embodiments, the one or more rolling wheels550may be directly attached to the heat cartridge (e.g., to the outlet die555). In other embodiments, the one or more rolling wheels550may be spaced apart from the heating cartridge. In such embodiments, the one or more rolling wheels550may move along with the heating cartridge to post-process the jacket after the jacket is formed.

FIG.13shows one example of a method800of using the system100(FIG.1) for additive manufacturing. The method800may be used to manufacture an implantable medical device.

The method800may include feeding the substrate802, for example, through a substrate channel in a heating cartridge. The substrate channel may be in fluid communication with an interior cavity of the heating cartridge.

The method800may include feeding one or more filaments804. For example, at least a first filament may be fed through a filament port of the heating cartridge into the interior cavity. In some embodiments, a second filament may be fed through another filament port into the interior cavity.

The method800may include melting one or more of the filaments806, for example, in the interior cavity. Any portion of the filaments contained in the interior cavity may be melted. In some embodiments, a second filament is melted with the first filament.

The method800may include moving the heating cartridge relative to the substrate808, for example, at least in a longitudinal direction to form a jacket comprising material from at least the first filament. The heating cartridge or substrate may also be rotated relative to one another. The jacket may be formed from material of at least the first filament. In some embodiments, the jacket may be formed from material of at least the first filament and the second filament.

The method800may also include altering the jacket810to define jacket features. These jacket features may include any suitable feature as described herein to modify the characteristics of the medical device being formed. For example, the jacket features may allow for interfacing with specific geometries and anatomical features. In other words, the jacket features may allow for controlling friction interfaces as well as create fixation or anchoring components on the external surface of the jacket body (e.g., such that the jacket features may accomplish various “jobs”). Further, the jacket features may assist in holding the medical device steady during device movement, may provide visual markers, or may adjust the mechanical properties of the device.

The jacket features may take the shape of various forms. For example, in one or more embodiments, the jacket features may include threads of differing/variable pitch added to the surface of the jacket. In one or more embodiments, the jacket features may include longitudinal splines added to the external surface of the jacket, e.g., as described in U.S. Pat. App. No. 63/001,832, entitled “3D PRINTED SPLINES ON MEDICAL DEVICES AND METHODS TO MANUFACTURE THE SAME,” which is herein incorporated by reference. In one or more embodiments, the jacket features may include elongated structures added to the surface of the jacket to, e.g., change the general shape profile (e.g., wings or two lobed, a triangle, a box/cube, etc.) of the jacket. In one or more embodiments, the jacket features may include intermittent surface elevations (e.g., non-continuous changes in thickness/diameter). In one or more embodiments, the jacket features may include a varying output geometry (e.g., a taper) of an outer surface of the jacket.

These externally added three-dimensional surface features of the jacket, as described herein, may aid in performance of a medical device or delivery system by, e.g., modifying the friction of interface surfaces between the medical device body and the anatomy of the patient, creating anchoring mechanisms for screwing or threading the medical device into an annular/cylindrical anatomical feature, or creating preferential performance characteristics (e.g., bending, straightening, torque, etc.).

Furthermore, these jacket features may be formed by any suitable tools. For example, the tools and process herein may provide a way to design and develop medical device features and methods of making the same. Specifically, as described herein, the jacket may be altered by adjusting the shaped and/or size of the jacket using a shutter, the jacket may be altered by trimming a portion of the jacket using one or more cutting tools, the jacket may be altered by depositing an additional filament on the jacket using an additional guide sheath, the jacket may be altered by imprinting a texture onto the jacket using one or more rolling wheels, etc.

Further, in some embodiments, the method800may also include adjusting a ratio of the first filament relative to the second filament over a longitudinal distance to change the Shore durometer of the catheter jacket over the longitudinal distance.

FIG.14shows another example of a method820of using the system100(FIG.1) for additive manufacturing. The method820may be used to manufacture an implantable medical device.

The method820may include feeding the substrate822, for example, through a substrate channel in a heating cartridge. The substrate channel may be in fluid communication with an interior cavity of the heating cartridge.

The method820may include feeding one or more filaments824. For example, at least a first filament may be fed through a filament port of the heating cartridge into the interior cavity. In some embodiments, a second filament may be fed through another filament port into the interior cavity.

The method820may include melting one or more of the filaments826, for example, in the interior cavity. Any portion of the filaments contained in the interior cavity may be melted. In some embodiments, a second filament is melted with the first filament.

The method820may include moving the heating cartridge relative to the substrate828, for example, at least in a longitudinal direction to form a jacket comprising material from at least the first filament. The heating cartridge or substrate may also be rotated relative to one another. The jacket may be formed from material of at least the first filament. In some embodiments, the jacket may be formed from material of at least the first filament and the second filament.

The method820may also include varying the rate of movement830between the heating cartridge and the substrate to define jacket features. For example, the controller may be configured to vary the longitudinal speed of the substrate relative to the heating cartridge. By varying the speed of movement of these components relative to one another during the formation of the jacket, the thickness of the jacket may change over the longitudinal distance. As a result, the jacket may define circumferential protrusions extending from an outer surface of the jacket, e.g., as shown inFIG.11. These intermittent changes in surface elevations of the jacket may provide varying characteristics to the jacket as described herein. Additionally, in one or more embodiments, the controller may vary the longitudinal speed of the substrate relative to the heating cartridge to define a taper of an outer surface of the jacket. Specifically, in one example, the taper may modify the jacket thickness from 9 French to 7 French. Further, in one or more embodiments, the system may include the heating cartridge (e.g., a tunnel die) illustrated inFIG.12to provide a taper while using varying longitudinal speeds.

Further, in some embodiments, the method820may also include adjusting a ratio of the first filament relative to the second filament over a longitudinal distance to change the Shore durometer of the catheter jacket over the longitudinal distance.

FIG.15shows yet another example of a method840of using the system100(FIG.1) for additive manufacturing. The method840may be used to manufacture an implantable medical device.

The method840may include feeding the substrate842, for example, through a substrate channel in a heating cartridge. The substrate channel may be in fluid communication with an interior cavity of the heating cartridge.

The method840may include feeding one or more filaments844. For example, at least a first filament may be fed through a filament port of the heating cartridge into the interior cavity. In some embodiments, a second filament may be fed through another filament port into the interior cavity.

The method840may include melting one or more of the filaments846, for example, in the interior cavity. Any portion of the filaments contained in the interior cavity may be melted. In some embodiments, a second filament is melted with the first filament.

The method840may include moving the heating cartridge relative to the substrate848, for example, at least in a longitudinal direction to form a jacket comprising material from at least the first filament. The heating cartridge or substrate may also be rotated relative to one another. The jacket may be formed from material of at least the first filament. In some embodiments, the jacket may be formed from material of at least the first filament and the second filament.

The method840may also include varying the rate of feeding850the first filament through the filament port to define a jacket features. For example, the controller may be configured to vary the feeding force applied to the one or more filaments. By varying the feeding force of the one or more filaments during the formation of the jacket, the thickness of the jacket may change over the longitudinal distance. As a result, the jacket may define circumferential protrusions extending from an outer surface of the jacket, e.g., as shown inFIG.11. These intermittent changes in surface elevations of the jacket may provide varying characteristics to the jacket as described herein. Additionally, in one or more embodiments, the controller may vary the feeding force applied to one or more filaments to define a taper of an outer surface of the jacket. Specifically, in one example, the taper may modify the jacket thickness from 9 French to 7 French. Further, in one or more embodiments, the system may include the heating cartridge illustrated inFIG.12to provide a taper while using varying feeding forces.

Further, in some embodiments, the method820may also include adjusting a ratio of the first filament relative to the second filament over a longitudinal distance to change the Shore durometer of the catheter jacket over the longitudinal distance.

ILLUSTRATIVE EMBODIMENTS

While the present disclosure is not so limited, an appreciation of various aspects of the disclosure will be gained through a discussion of the specific examples and illustrative embodiments provided below. Various modifications of the examples and illustrative embodiments, as well as additional embodiments of the disclosure, will become apparent herein.

A1. An additive manufacturing apparatus comprising:

a heating block at least partially defining an interior volume to allow an elongate substrate to pass through the interior volume and through the heating block, wherein the heating block at least partially defines a first filament port in fluid communication with the interior volume;a first guide sheath coupled to the heating block and extending into the first filament port from an exterior of the heating block, the first guide sheath defining a lumen in fluid communication with the interior volume; andan outlet die located proximate a distal side of the heating block and at least partially defining the interior volume, wherein outlet die at least partially defines a substrate outlet for the elongate substrate, wherein the substrate outlet is adapted to be selectively adjusted to modify the size and/or shape of the substrate outlet.
A2. The apparatus according to embodiment A1, further comprising a shutter defining an opening spaced longitudinally from the substrate outlet, wherein the shutter comprises 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.
A3. The apparatus 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.
A4. The apparatus according to embodiment A3, wherein the shutter further comprises one or more linkage, wherein each linkage corresponds to a fin of the one or more fins, wherein each linkage extends between a first end region movably coupled to the body portion and a second end region movably coupled to the corresponding fin, wherein body portion defines one or more slots within which each linkage is movably coupled.
A5. The apparatus according to embodiment A2, wherein the shutter is located distal to the substrate outlet.
A6. The apparatus according to embodiment A2, wherein the shutter is located proximal to the substrate outlet.
A7. The apparatus according to embodiment A2, wherein the shutter is directly attached to the outlet die.
A8. The apparatus according to embodiment A2, wherein the shutter is spaced apart from the outlet die.
A9. The apparatus according to any preceding A embodiment, further comprising an inlet die at least partially defining a substrate inlet port, wherein the interior volume is at least partially defined by the inlet die coupled to a proximal side of the heating block.
A10. The apparatus according to any preceding A embodiment, wherein the substrate outlet port defines one, two, three, four, or more cutouts.
A11. The apparatus according to any preceding A embodiment, wherein the substrate outlet port defines one, two, three, four, or more protrusions.
A12. The apparatus according to any preceding A embodiment, wherein the heating block at least partially defines a second filament port in fluid communication with the interior volume.
A13. The apparatus according to any preceding A embodiment, further comprising one or more heating elements thermally coupled to the heating block to melt filament material in the interior volume.
B1. An additive manufacturing system comprising:a heating cartridge extending from a proximal side to a distal side and comprising a substrate inlet port at the proximal side and a substrate outlet port at the distal side, the heating cartridge defining an interior volume and a substrate channel extending through the interior volume from the proximal side to the distal side, wherein the heating cartridge defines a first filament port in fluid communication with the interior volume to receive the first filament;a heating element thermally coupled to the heating cartridge to heat the interior volume;a filament handling system comprising one or more motors to feed at least a first filament through the first filament port into the interior volume;a substrate handling system comprising:a head stock comprising a distal clamp to secure a distal portion of an elongate substrate, wherein the substrate is positioned to pass through the substrate channel when secured by the head stock; andone or more motors to translate or rotate one or both of the substrate when secured by the headstock and the heating cartridge relative to one another;a controller operably coupled to the heating element, one or more motors of the filament handling system, and one or more motors of the substrate handling system, the controller configured to:activate the heating element to melt any portion of the first filament in the interior volume;control the one or more motors of the filament handling system to selectively control the feeding of the first filament into the interior volume; andcontrol one or more motors of the substrate handling system to move one or both of the substrate and the heating cartridge relative to one another in at least a longitudinal direction to form an elongate catheter jacket around the substrate, wherein the catheter jacket comprises material from the first filament; anda shutter comprising a body portion defining a channel spaced longitudinally from the substrate outlet port of the heating cartridge, wherein the shutter is adapted to be selectively adjusted to modify the size and/or shape of the substrate outlet port and engage the catheter jacket.
B2. The system according to embodiment B1, wherein the shutter 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.
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.
B4. The system according to embodiment B3, wherein the shutter further comprises one or more linkage, wherein each linkage corresponds to a fin of the one or more fins, wherein each linkage extends between a first end region movably coupled to the body portion and a second end region movably coupled to the corresponding fin, wherein body portion defines one or more slots within which each linkage is movably coupled.
B5. The system according to embodiment B2, wherein the shutter is located distal to the substrate outlet port.
B6. The system according to embodiment B2, wherein the shutter is located proximal to the substrate outlet port.
B7. The system according to embodiment B2, wherein the shutter is directly attached to the heating cartridge.
B8. The system according to embodiment B2, wherein the shutter is spaced apart from the heating cartridge.
B9. The system according to any preceding B embodiment, wherein the heating cartridge further comprises a second filament port in fluid communication with the interior volume, wherein the one or more motors of the filament handling system are adapted to feed a second filament through the second filament port into the interior volume, wherein the controller is configured to:activate the heating element to melt any portion of the second filament in the interior volumecontrol the one or more motors of the filament handling system to selectively control the feeding of the second filament into the interior volume, wherein the catheter jacket comprises material from at least one of the first filament and the second filament
B10. The system according to any preceding B embodiment, wherein the heating cartridge comprises an inlet die, an outlet die, and a heating block, wherein heating block defines the first filament port and the second filament port.
B11. The system according to any preceding B embodiment, wherein one or both of the substrate inlet port and the substrate outlet port defines one, two, three, four, or more cutouts, and the controller is configured to rotate the substrate relative to the heating cartridge while translating the substrate relative to the heating cartridge to form the elongate catheter jacket around the substrate.
B12. The system according to embodiment B11, wherein the substrate outlet port defines the one, two, three, four, or more cutouts and the catheter jacket comprises a number of helical protrusions corresponding to the number of cutouts.
B13. The system according to any preceding B embodiment, wherein one or both of the substrate inlet port and the substrate outlet port defines one, two, three, four, or more protrusions.
B14. The system according to embodiment B13, wherein the substrate outlet port includes the one, two, three, four, or more protrusions and the catheter jacket comprises a corresponding number of channels.
B15. The system according to any preceding B embodiment, wherein the controller is configured to move the head stock in at least the longitudinal direction away from the heating cartridge to form the catheter jacket.
B16. The system according to any preceding B embodiment, wherein the substrate handling system comprises a tail stock comprising a proximal clamp to secure a proximal portion of the substrate.
B17. The system according to embodiment B16, wherein the controller is configured to move the heating cartridge in at least the longitudinal direction away from the head stock to form the catheter jacket.
B18. The system according to any preceding B embodiment, further comprising the substrate, wherein the substrate comprises a lubricious coating, a liner, and a braid, and the catheter jacket is formed around the braid.
C1. An additive manufacturing apparatus comprising:a heating block at least partially defining an interior volume to allow an elongate substrate to pass through the interior 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 interior volume;a first guide sheath coupled to the heating block and extending into the first filament port from an exterior of the heating block, the first guide sheath defining a lumen in fluid communication with the interior volume;an outlet die located proximate a distal side of the heating block and at least partially defining the interior volume, wherein outlet die at least partially defines a substrate outlet for the elongate substrate; andone or more cutting tools spaced longitudinally from the substrate outlet, wherein each cutting tool of the one or more cutting tools comprises a cutting edge oriented towards the longitudinal axis.
C2. The apparatus according to any preceding C embodiment, wherein each cutting tool of the one or more cutting tools extends between a base edge and the cutting edge along a cutting axis, wherein the cutting axis positioned at an angle to the longitudinal axis of less than or equal to about 45 degrees.
C3. The apparatus according to any preceding C embodiment, wherein the one or more cutting tools are movably coupled to the outlet die.
C4. The apparatus according to any preceding C embodiment, wherein the one or more cutting tools are configured to move between an engaged position and a spaced apart position.
C5. The apparatus according to any preceding C embodiment, wherein the cutting edge is positioned between an edge of the substrate outlet and the longitudinal axis.
C6. The apparatus according to any preceding C embodiment, wherein the one or more cutting tools comprises one, two, three, or four cutting tools.
C7. The apparatus according to any preceding C embodiment, wherein the one or more cutting tools are located distal to the substrate outlet.
C8. The apparatus according to embodiments C1-C6, wherein the one or more cutting tools are located proximal to the substrate outlet.
C9. The apparatus according to any preceding C embodiment, wherein the one or more cutting tools are directly attached to the outlet die.
C10. The apparatus according to embodiments C1-C8, wherein the one or more cutting tools are spaced apart from the outlet die.
D1. An additive manufacturing system comprising:a heating cartridge extending from a proximal side to a distal side and comprising a substrate inlet port at the proximal side and a substrate outlet port at the distal side, the heating cartridge defining an interior volume and a substrate channel extending through the interior volume from the proximal side to the distal side, wherein the heating cartridge defines a first filament port in fluid communication with the interior volume to receive the first filament;a heating element thermally coupled to the heating cartridge to heat the interior volume;a filament handling system comprising one or more motors to feed at least a first filament through the first filament port into the interior volume;a substrate handling system comprising:a head stock comprising a distal clamp to secure a distal portion of an elongate substrate, wherein the substrate is positioned to pass through the substrate channel along a longitudinal axis when secured by the head stock; andone or more motors to translate or rotate one or both of the substrate when secured by the headstock and the heating cartridge relative to one another;a controller operably coupled to the heating element, one or more motors of the filament handling system, and one or more motors of the substrate handling system, the controller configured to:activate the heating element to melt any portion of the first filament in the interior volume;control the one or more motors of the filament handling system to selectively control the feeding of the first filament into the interior volume; andcontrol one or more motors of the substrate handling system to move one or both of the substrate and the heating cartridge relative to one another in at least a longitudinal direction to form an elongate catheter jacket around the substrate, wherein the catheter jacket comprises material from the first filament; andone or more cutting tools spaced longitudinally from the substrate outlet port of the heating cartridge, wherein each cutting tool of the one or more cutting tools comprises a cutting edge oriented towards the longitudinal axis and configured to selectively engage the catheter jacket.
D2. The system according to any preceding D embodiment, wherein each cutting tool of the one or more cutting tools extends between a base edge and the cutting edge along a cutting axis, wherein the cutting axis positioned at an angle to the longitudinal axis of less than or equal to about 45 degrees.
D3. The system according to any preceding D embodiment, wherein the one or more cutting tools are movably coupled to the heating cartridge.
D4. The system according to any preceding D embodiment, wherein the one or more cutting tools are configured to move between an engaged position and a spaced apart position.
D5. The system according to any preceding D embodiment, wherein the cutting edge is positioned between an edge of the substrate outlet and the longitudinal axis.
D6. The system according to any preceding D embodiment, wherein the one or more cutting tools comprises one, two, three, or four cutting tools.
D7. The system according to any preceding D embodiment, wherein the one or more cutting tools are located distal to the substrate outlet port.
D8. The system according to embodiments D1-D6, wherein the one or more cutting tools are located proximal to the substrate outlet port
D9. The system according to any preceding D embodiment, wherein the one or more cutting tools are directly attached to the heating cartridge.
D10. The system according to embodiments D1-D8, wherein the one or more cutting tools are spaced apart from the heating cartridge.
E1. An additive manufacturing apparatus comprising:a heating block at least partially defining an interior volume to allow an elongate substrate to pass through the interior 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 interior volume;a first guide sheath coupled to the heating block and extending into the first filament port from an exterior of the heating block, the first guide sheath defining a lumen in fluid communication with the interior volume;an outlet die located proximate a distal side of the heating block and at least partially defining the interior volume, wherein outlet die at least partially defines a substrate outlet for the elongate substrate; andan additional guide sheath distal the outlet die and defining an additional filament lumen configured to receive an additional filament.
E2. The apparatus according to any preceding E embodiment, wherein the additional guide sheath is directly attached to the outlet die.
E3. The apparatus according to embodiment E1, wherein the additional guide sheath is spaced apart from the outlet die.
F1. An additive manufacturing system comprising:a heating cartridge extending from a proximal side to a distal side and comprising a substrate inlet port at the proximal side and a substrate outlet port at the distal side, the heating cartridge defining an interior volume and a substrate channel extending through the interior volume from the proximal side to the distal side, wherein the heating cartridge defines a first filament port in fluid communication with the interior volume to receive the first filament;a heating element thermally coupled to the heating cartridge to heat the interior volume;a filament handling system comprising one or more motors to feed at least a first filament through the first filament port into the interior volume;a substrate handling system comprising:a head stock comprising a distal clamp to secure a distal portion of an elongate substrate, wherein the substrate is positioned to pass through the substrate channel along a longitudinal axis when secured by the head stock; andone or more motors to translate or rotate one or both of the substrate when secured by the headstock and the heating cartridge relative to one another;a controller operably coupled to the heating element, one or more motors of the filament handling system, and one or more motors of the substrate handling system, the controller configured to:activate the heating element to melt any portion of the first filament in the interior volume;control the one or more motors of the filament handling system to selectively control the feeding of the first filament into the interior volume; andcontrol one or more motors of the substrate handling system to move one or both of the substrate and the heating cartridge relative to one another in at least a longitudinal direction to form an elongate catheter jacket around the substrate, wherein the catheter jacket comprises material from the first filament; andan additional guide sheath distal the heating block and defining an additional filament lumen configured to receive an additional filament, wherein the additional guide sheath is configured to selectively deposit the additional filament on the catheter jacket.
F2. The system according to any preceding F embodiment, wherein the additional guide sheath is directly attached to the heating cartridge.
F3. The system according to embodiment F1, wherein the additional guide sheath is spaced apart from the heating cartridge.
F4. The system according to any preceding F embodiment, wherein the additional guide sheath is configured to move relative to the elongate substrate.
F5. The system according to any preceding F embodiment, wherein the additional filament comprises a same material as the first filament.
F6. The system according to any preceding F embodiment, wherein the additional filament comprises a different material than the first filament.
F7. The system according to any preceding F embodiment, wherein the additional filament lumen comprises multiple ports through which the additional filament is deposited on the catheter jacket.
G1. An additive manufacturing apparatus comprising:a heating block at least partially defining an interior volume to allow an elongate substrate to pass through the interior 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 interior volume;a first guide sheath coupled to the heating block and extending into the first filament port from an exterior of the heating block, the first guide sheath defining a lumen in fluid communication with the interior volume;an outlet die located proximate a distal side of the heating block and at least partially defining the interior volume, wherein outlet die at least partially defines a substrate outlet for the elongate substrate; andone or more rolling wheels spaced longitudinally from the substrate outlet, wherein each rolling wheel of the one or more rolling wheels is configured to rotate about an axis perpendicular to the longitudinal axis and defines an outer surface facing the longitudinal axis.
G2. The apparatus according to any preceding G embodiment, wherein each rolling wheel of the one or more rolling wheels define a width of about 1 mm.
G3. The apparatus according to any preceding G embodiment, wherein the outer surface of the one or more rolling wheels define a textured pattern.
G4. The apparatus according to any preceding G embodiment, wherein the one or more rolling wheels are configured to move laterally between an engaged position and a spaced apart position.
G5. The apparatus according to any preceding G embodiment, wherein the one or more rolling wheels comprises one, two, three, or four rolling wheels.
G6. The apparatus according to any preceding G embodiment, wherein the one or more rolling wheels are located distal to the substrate outlet.
H1. An additive manufacturing system comprising:a heating cartridge extending from a proximal side to a distal side and comprising a substrate inlet port at the proximal side and a substrate outlet port at the distal side, the heating cartridge defining an interior volume and a substrate channel extending through the interior volume from the proximal side to the distal side, wherein the heating cartridge defines a first filament port in fluid communication with the interior volume to receive the first filament;a heating element thermally coupled to the heating cartridge to heat the interior volume;a filament handling system comprising one or more motors to feed at least a first filament through the first filament port into the interior volume;a substrate handling system comprising:a head stock comprising a distal clamp to secure a distal portion of an elongate substrate, wherein the substrate is positioned to pass through the substrate channel along a longitudinal axis when secured by the head stock; andone or more motors to translate or rotate one or both of the substrate when secured by the headstock and the heating cartridge relative to one another;a controller operably coupled to the heating element, one or more motors of the filament handling system, and one or more motors of the substrate handling system, the controller configured to:activate the heating element to melt any portion of the first filament in the interior volume;control the one or more motors of the filament handling system to selectively control the feeding of the first filament into the interior volume; andcontrol one or more motors of the substrate handling system to move one or both of the substrate and the heating cartridge relative to one another in at least a longitudinal direction to form an elongate catheter jacket around the substrate, wherein the catheter jacket comprises material from the first filament; andone or more rolling wheels spaced longitudinally from the substrate outlet port of the heating cartridge, wherein each rolling wheel of the one or more rolling wheels is configured to rotate about an axis perpendicular to the longitudinal axis and defines an outer surface configured to engage the catheter jacket to imprint features thereon.
H2. The system according to any preceding H embodiment, wherein each rolling wheel of the one or more rolling wheels define a width of about 1 mm.
H3. The system according to any preceding H embodiment, wherein the outer surface of the one or more rolling wheels define a textured pattern.
H4. The system according to any preceding H embodiment, wherein the one or more rolling wheels are configured to move laterally between an engaged position and a spaced apart position.
H5. The system according to any preceding H embodiment, wherein the one or more rolling wheels comprises one, two, three, or four rolling wheels.
H6. The system according to any preceding H embodiment, wherein the one or more rolling wheels are located distal to the substrate outlet port.
I1. A method for additive manufacturing of an implantable medical device, the method comprising:feeding a substrate through a substrate channel in a heating cartridge, the substrate channel in fluid communication with an interior cavity of the heating cartridge;feeding at least a first filament through a filament port into the interior cavity;melting the first filament in the interior cavity;moving the heating cartridge relative to the substrate at least in a longitudinal direction to form a jacket comprising material from at least the first filament; and altering the jacket to define jacket features.
I2. The method according to embodiment I1, wherein altering the catheter jacket comprises adjusting the shape and/or size of the catheter jacket using a shutter.
I3. The method according to embodiment I1, wherein altering the catheter jacket comprises trimming a portion of the catheter jacket using one or more cutting tools.
I4. The method according to embodiment I1, wherein altering the catheter jacket comprises depositing an additional filament on the catheter jacket using an additional guide sheath.
I5. The method according to embodiment I1, wherein altering the catheter jacket comprises imprinting a texture onto the catheter jacket using one or more rolling wheels.
I6. The method according to any preceding I embodiment, wherein the catheter jacket features comprise a taper of an outer surface of the catheter jacket.
I7. The method according to any preceding I embodiment, wherein the catheter jacket features comprise circumferential protrusions extending from an outer surface of the catheter jacket.
I8. The method according to any preceding I embodiment, wherein the catheter jacket features comprise variable splines extending from an outer surface of the catheter jacket.
I9. The method according to any preceding I embodiment, further comprising:feeding a second filament through another filament port into the interior cavity; andmelting the second filament with the first filament to form the catheter jacket comprising material from at least the first filament and the second filament
I10. The method according to embodiment I9, further comprising adjusting a ratio of the first filament relative to the second filament over a longitudinal distance to change the Shore durometer of the catheter jacket over the longitudinal distance.
J1. A method for additive manufacturing of an implantable medical catheter, the method comprising:feeding a substrate through a substrate channel in a heating cartridge, the substrate channel in fluid communication with an interior cavity of the heating cartridge;feeding at least a first filament through a filament port into the interior cavity;melting the first filament in the interior cavity;moving the heating cartridge relative to the substrate at least in a longitudinal direction to form a catheter jacket comprising material from at least the first filament; andvarying the rate of movement between the heating cartridge and the substrate to define catheter jacket features.
J2. The method according to embodiment J1, wherein the catheter jacket features comprise a taper of an outer surface of the catheter jacket
J3. The method according to embodiment J1, wherein the catheter jacket features comprise circumferential protrusions extending from an outer surface of the catheter jacket.
K1. A method for additive manufacturing of an implantable medical catheter, the method comprising:feeding a substrate through a substrate channel in a heating cartridge, the substrate channel in fluid communication with an interior cavity of the heating cartridge;feeding at least a first filament through a filament port into the interior cavity;melting the first filament in the interior cavity;moving the heating cartridge relative to the substrate at least in a longitudinal direction to form a catheter jacket comprising material from at least the first filament; andvarying the rate of feeding the first filament through the filament port to define catheter jacket features.
K2. The method according to embodiment K1, wherein the catheter jacket features comprise a taper of an outer surface of the catheter jacket
K3. The method according to embodiment K1, wherein the catheter jacket features comprise circumferential protrusions extending from an outer surface of the catheter jacket.

All references and publications cited herein are expressly incorporated herein by reference in their entirety for all purposes, except to the extent any aspect directly contradicts this disclosure.

Unless otherwise indicated, all numbers expressing feature sizes, amounts, and physical properties used in the specification and claims may be understood as being modified either by the term “exactly” or “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the foregoing specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by those skilled in the art utilizing the teachings disclosed herein or, for example, within typical ranges of experimental error.

As used herein, the term “configured to” may be used interchangeably with the terms “adapted to” or “structured to” unless the content of this disclosure clearly dictates otherwise.

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