# US 10,864,099 B2 · Immobilisation element and additive manufacturing method for making same

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- Number: US 10,864,099 B2
- Document ID: US10864099B2
- Status: Granted
- Kind: B2
- Application number: 15/540,515
- Filed: 2015-12-23
- Published: 2018-01-04
- Granted: 2020-12-15
- Earliest claimed: 2014-12-31
- Assignees: Orfit Industries
- Applicants: Orfit Industries N.V.
- Inventors: Steven Cuypers; Bogdan Bogdanov; Simon De Gruytere
- Web page: https://patentgrep.com/patent/US10864099B2

## CPC

- A61F 5/0118: {for the arms, hands or fingers}
- A61F 5/05875: {for fingers}
- A61F 5/37: Restraining devices for the body or for body parts; Restraining shirts
- A61F 5/3707: {for the head (cervical supports A61F5/055; splints A61F5/05883)}
- A61L 15/12: containing macromolecular materials
- B29C 64/106: using only liquids or viscous materials, e.g. depositing a continuous bead of viscous material
- B29C 64/118: using filamentary material being melted, e.g. fused deposition modelling [FDM]
- B29C 64/153: using layers of powder being selectively joined, e.g. by selective laser sintering or melting
- B29C 64/209: Heads; Nozzles
- B33Y 10/00: Processes of additive manufacturing
- B33Y 70/00: Materials specially adapted for additive manufacturing
- B33Y 80/00: Products made by additive manufacturing
- G05B 19/4099: Surface or curve machining, making three-dimensional [3D] objects, e.g. desktop manufacturing
- B29K 2067/04: {Polyesters derived from hydroxycarboxylic acids}
- B29K 2101/10: Thermosetting resins
- B29K 2105/0005: {containing compounding ingredients (releasing, lubricating or separating agents B29C33/56, fibers B29K2105/08, B29K2105/12; fillers B29K2105/16, recycled material B29K2105/26)}
- B29K 2105/162: {Nanoparticles}
- B29K 2507/04: Carbon
- B29K 2995/0041: Crystalline
- B29L 2031/753: {Medical equipment; Accessories therefor (bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008)}
- G05B 2219/35134: 3-D cad-cam
- G05B 2219/49007: Making, forming 3-D object, model, surface
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- 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
- G05B: CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS (systems for controlling or regulating non-electric variables G05D; systems for regulating electric or magnetic variables G05F; control devices or systems insofar as characterised by mechanical features only G05G)
- 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

This invention relates to a method for manufacturing an individualized immobilization element for the non-invasive immobilization and/or mobilization of at least a segment of a body part of a patient in a predetermined position relative to a reference and/or in a pre-certain configuration. The method comprises the steps of (i) providing a data set that comprises a three-dimensional image of an outer contour of at least a part of the segment of the body part to be immobilized and/or mobilized and (ii) the manufacture of at least a part of the immobilization element by rapid manufacturing of a shape on the basis of said data set using a polymeric material containing a thermoplastic polymer having a melting point less than or equal to 100° C., wherein the polymer material contains a nucleating agent for enhancing the of the crystallization of the thermoplastic polymer.

## Claims

### Claim 1

A method for manufacturing an individualized immobilization element for the non-invasive immobilization and/or mobilization of at least a segment of a body part of a patient at a predetermined position relative to a reference and/or in a predetermined configuration, the method comprising:
providing a data set that comprises a three-dimensional image of an outer contour of at least a portion of the segment of the body part to be immobilized and/or mobilized; and
manufacturing of at least a part of the immobilization element by rapid manufacturing of a shape based on the data set, using a polymeric material containing a thermoplastic polymer having a melting point less than or equal to 100° C.,
wherein the polymeric material contains a nucleating agent capable of enhancing crystallization of the thermoplastic polymer,
wherein at least a portion of an inner surface of the shape has an inner contour which is complementary to the outer contour of the segment of the body part to be immobilized and/or mobilized, and
wherein the immobilization element is manufactured by extrusion of a filament or co-extrusion of two or more filaments of the same or a different polymeric material and deposition of a plurality of successive filaments according to a pattern controlled by the data set.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the polymeric material comprises nanoparticles as a nucleating agent for enhancing the crystallization of the thermoplastic polymer.

### Claim 3 (depends on 2)

The method according to claim 2, wherein the thermoplastic polymer contains between 0.01 and 10 wt. % of carbon nano-tubes, relative to a weight of the thermoplastic polymer.

### Claim 4 (depends on 3)

The method according to claim 3, wherein the carbon nano-tubes are carbon nanotubes having a multi-layer wall.

### Claim 5 (depends on 2)

The method according to claim 2, wherein the thermoplastic polymer contains between 1.0 and 15.0 wt. % of a organically modified clay, relative to a weight of the thermoplastic polymer.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the thermoplastic polymer is selected from the group consisting of thermoplastic elastomers, thermoplastic polyurethane, thermoplastic polyisoprene, thermoplastic polyesters, thermoplastic polyolefins, polyvinyl chloride, polystyrene, and a combination of two or more of these polymers.

### Claim 7 (depends on 6)

The method according to claim 6, wherein the thermoplastic polymer comprises c-polycaprolactone.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the at least one filament is a monofilament of the polymeric material.

### Claim 9 (depends on 8)

The method according to claim 8, wherein the at least one filament has a diameter between 0.5 and 5.0 mm.

### Claim 10 (depends on 1)

The method according to claim 1, wherein the polymeric material comprises at least one thermosetting resin.

### Claim 11 (depends on 1)

The method according to claim 1, wherein a layer of the polymeric material is deposited in a molten state, according to a pattern controlled by said data set, and in the molten state is at least partially cross-linked, after which the polymeric material is cooled.

### Claim 12 (depends on 1)

The method according to claim 1, wherein the deposition is by fused deposition modeling.

### Claim 13 (depends on 1)

The method according to claim 1, wherein the at least one filament is at least partially cross-linked after extrusion and deposition.

### Claim 14 (depends on 1)

The method according to claim 1, wherein two or more polymeric materials are co-extruded in a thickness-direction of the immobilization element such that the immobilization element contains two or more layers of polymeric material in the thickness direction of the immobilization element, and
wherein a first layer of polymeric material comprises a first thermoplastic polymer and a second layer of polymeric material comprises a second thermoplastic polymer.

### Claim 15 (depends on 1)

The method according to claim 1, wherein simultaneously with the extruding the at least one filament, a filament is extruded of a fibrous reinforcement material.

### Claim 16 (depends on 1)

The method according to claim 1, wherein the immobilization element comprises a first part manufactured out of a first polymeric material comprising a first thermoplastic polymer and a second part is manufactured out of a second material different from the first polymeric material.

### Claim 17 (depends on 1)

An individualized immobilization element for the non-invasive immobilization and/or mobilization of at least a segment of a body part of a patient in a predetermined configuration and/or at a predetermined position relative to a reference, obtained by the method of claim 1, comprising:
a first portion manufactured of a first material and configured to cover the segment of the body part; and
a second portion manufactured of a second material and configured to cover healthy tissue of the patient,
wherein a contour of an inner surface of the immobilization element corresponds to at least a part of the outer contour of the segment of the body part to be immobilized.

### Claim 18 (depends on 17)

The individualized immobilization element according to claim 17, at least partly manufactured from a laminated material.

### Claim 19 (depends on 18)

The individualized immobilization element according to claim 18, wherein a layer of the second material is applied to the inner surface of the immobilization element.

### Claim 20 (depends on 17)

The individualized immobilization element according to claim 17, wherein one or more fasteners for connecting one or more edges of the immobilization element with a support for the patient, are manufactured in one part with the immobilization element.

### Claim 21 (depends on 17)

The individualized immobilization element according to claim 17, at least in part made of ε-polycaprolactone.