# US 2022/0032002 A1 · Systems and methods for manufacturing 3d printed medical devices

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- Number: US 2022/0032002 A1
- Document ID: US20220032002A1
- Status: Published application
- Kind: A1
- Application number: 17/389,226
- Filed: 2021-07-29
- Published: 2022-02-03
- Earliest claimed: 2020-07-31
- Assignees: Medtronic, Inc.
- Applicants: Medtronic, Inc.
- Inventors: Jonathan E. Baxter; Kristin M. Johnson; Gregory N. Nesseth; Jay T. Rassat
- Web page: https://patentgrep.com/patent/US20220032002A1

## CPC

- A61M 25/0009: {Making of catheters or other medical or surgical tubes}
- B29C 64/118: using filamentary material being melted, e.g. fused deposition modelling [FDM]
- B29C 64/209: Heads; Nozzles
- B29C 64/227: Driving means
- B29C 64/236: for motion in a direction within the plane of a layer
- B29C 64/241: for rotary motion
- B29C 64/245: Platforms or substrates (support structures intended to be sacrificed after manufacture B29C64/40)
- B29C 64/295: Heating elements
- B29C 64/336: of two or more materials
- B29C 64/393: for controlling or regulating additive manufacturing processes
- B33Y 10/00: Processes of additive manufacturing
- B33Y 30/00: Apparatus for additive manufacturing; Details thereof or accessories therefor
- B33Y 40/00: Auxiliary operations or equipment, e.g. for material handling
- B33Y 50/02: for controlling or regulating additive manufacturing processes
- B33Y 80/00: Products made by additive manufacturing
- A61M 2207/10: Device therefor
- B29L 2031/7542: {Catheters}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00)
- B33Y: ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES

## Abstract

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.

## Claims

### Claim 1

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; and
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, wherein the substrate outlet is adapted to be selectively adjusted to modify a size and/or shape of the substrate outlet.

### Claim 2 (depends on 1)

The apparatus of claim 1, 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.

### Claim 3 (depends on 2)

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

### Claim 4 (depends on 3)

The apparatus of claim 3, 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.

### Claim 5 (depends on 2)

The apparatus of claim 2, wherein the shutter is located distal to the substrate outlet.

### Claim 6 (depends on 2)

The apparatus of claim 2, wherein the shutter is located proximal to the substrate outlet.

### Claim 7 (depends on 2)

The apparatus of claim 2, wherein the shutter is directly attached to the outlet die.

### Claim 8 (depends on 1)

The apparatus of claim 1, wherein the heating block at least partially defines a second filament port in fluid communication with the interior volume.

### Claim 9

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 elongate substrate is positioned to pass through the substrate channel when secured by the head stock; and
one or more motors to translate or rotate one or both of the elongate substrate when secured by the head stock 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; and
control one or more motors of the substrate handling system to move one or both of the elongate substrate and the heating cartridge relative to one another in at least a longitudinal direction to form an elongate catheter jacket around the elongate substrate, wherein the catheter jacket comprises material from the first filament; and
a 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 a size and/or shape of the substrate outlet port and engage the catheter jacket.

### Claim 10 (depends on 9)

The system of claim 9, 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.

### Claim 11 (depends on 10)

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

### Claim 12 (depends on 11)

The system of claim 11, 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.

### Claim 13 (depends on 9)

The system of claim 9, 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 volume
control 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

### Claim 14 (depends on 9)

The system of claim 9, 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.

### Claim 15 (depends on 9)

The system of claim 9, further comprising the elongate substrate, wherein the elongate substrate comprises a lubricious coating, a liner, and a braid, and the catheter jacket is formed around the braid.

### Claim 16

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.

### Claim 17 (depends on 16)

The method of claim 16, wherein altering the jacket comprises adjusting a shape and/or size of the jacket using a shutter.

### Claim 18 (depends on 16)

The method of claim 16, wherein the jacket features comprise variable splines extending from an outer surface of the jacket.

### Claim 19 (depends on 16)

The method of claim 16, further comprising:
feeding a second filament through another filament port into the interior cavity; and
melting the second filament with the first filament to form the jacket comprising material from at least the first filament and the second filament

### Claim 20 (depends on 19)

The method of claim 19, further comprising adjusting a ratio of the first filament relative to the second filament over a longitudinal distance to change a Shore durometer of the jacket over the longitudinal distance.