# US 2022/0032003 A1 · Systems and methods for manufacturing 3d printed medical devices

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- Number: US 2022/0032003 A1
- Document ID: US20220032003A1
- Status: Published application
- Kind: A1
- Application number: 17/389,232
- 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
- Web page: https://patentgrep.com/patent/US20220032003A1

## CPC

- A61M 25/0012: {with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils}
- 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 64/241: for rotary motion
- 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
- A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence)
- B29C 64/227: Driving means
- B29C 64/40: Structures for supporting 3D objects during manufacture and intended to be sacrificed after completion thereof
- B29K 2995/007: Hardness
- 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
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- B29K: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR {MOULDS, } REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES

## Abstract

Systems and methods of manufacturing 3D printed medical devices. The method includes feeding a first filament and a second filament into an interior cavity of a heating cartridge and melting each of the filaments on a substrate. The heating cartridge is then moved linearly and rotationally relative to the substrate to form a jacket including material from each of the first and second filaments. Further, rotating the substrate provides a uniform mixture and creates support rings between the filament materials within the structure of the jacket.

## Claims

### Claim 1

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 and a second filament port in fluid communication with the interior volume to receive the second 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 and a second filament through the second 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 along a longitudinal direction 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; and
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:
control the one or more motors of the filament handling system to selectively control the feeding of the first filament and the second filament into the interior volume;
activate the heating element to melt any portion of the first filament or the second filament in 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 a longitudinal direction to form an elongate catheter jacket around the elongate substrate, wherein the catheter jacket comprises material from at least the first filament and the second filament; 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 a rotational direction about the longitudinal direction such that the first and second filaments create discrete rings.

### Claim 2 (depends on 1)

The system of claim 1, wherein the elongate substrate and the heating cartridge move relative to one another in the rotational direction at a rate of about 260 RPM.

### Claim 3 (depends on 1)

The system of claim 1, wherein the elongate substrate and the heating cartridge move relative to one another in the longitudinal direction and the rotational direction at a ratio of about 44 revolutions per inch.

### Claim 4 (depends on 1)

The system of claim 1, wherein the elongate catheter jacket comprises particulate proximate an outer surface of the catheter jacket.

### Claim 5 (depends on 1)

The system of claim 1, wherein the first filament has a Shore durometer less than or equal to 72D.

### Claim 6 (depends on 1)

The system of claim 1, wherein the first filament has a Shore durometer 10D less than a Shore durometer of the second filament.

### Claim 7 (depends on 1)

The system of claim 1, wherein the heating cartridge comprises an inlet die, a heating block, and an outlet die, wherein heating block defines the first filament port and the second filament port.

### Claim 8 (depends on 1)

The system of claim 1, wherein the controller is configured to change a feeding force applied to at least one of the first filament and the second filament to change a ratio of material in the catheter jacket over a longitudinal distance.

### Claim 9 (depends on 8)

The system of claim 8, wherein the change in ratio of material in the catheter jacket over the longitudinal distance is continuous.

### Claim 10 (depends on 1)

The system of claim 1, 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 11

A method for additive manufacturing of an implantable medical device, the method comprising:
feeding a substrate through a substrate channel in a heating cartridge along a longitudinal axis, the substrate channel in fluid communication with an interior cavity of the heating cartridge;
feeding a first filament through a filament port into the interior cavity;
feeding a second filament through another filament port into the interior cavity;
melting the first and second filaments 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 and second filaments; and
moving the heating cartridge relative to the substrate in a rotational direction about the longitudinal axis such that the first and second filaments create discrete rings in forming the catheter jacket.

### Claim 12 (depends on 11)

The method of claim 11, 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 catheter jacket over the longitudinal distance.

### Claim 13 (depends on 12)

The method of claim 12, wherein the change in ratio of material in the catheter jacket over the longitudinal distance is continuous.

### Claim 14 (depends on 11)

The method of claim 11, wherein moving the heating cartridge relative to the substrate in a rotational direction comprises moving at a rate of 260 RPM

### Claim 15 (depends on 11)

The method of claim 11, wherein moving the heating cartridge relative to the substrate comprises moving at a rotational direction to longitudinal direction ratio of about 44 revolutions per inch.

### Claim 16 (depends on 11)

The method of claim 11, wherein the first filament has a Shore durometer less than or equal to 72D.

### Claim 17 (depends on 11)

The method of claim 11, wherein the first filament has a Shore durometer 10D less than a Shore durometer of the second filament.

### Claim 18 (depends on 11)

The method of claim 11, further comprising adding particulate to the catheter jacket prior to moving the heating cartridge relative to the substrate in the rotational direction.