# US 10,441,689 B2 · Methods and devices for three-dimensional printing or additive manufacturing of bioactive medical devices

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- Number: US 10,441,689 B2
- Document ID: US10441689B2
- Status: Granted
- Kind: B2
- Application number: 14/822,275
- Filed: 2015-08-10
- Published: 2016-02-11
- Granted: 2019-10-15
- Earliest claimed: 2014-08-10
- Assignees: Louisiana Tech Research Corporation
- Applicants: Louisiana Tech Research Corporation
- Inventors: Jeffery Adam Weisman; Connor Nicholson; David Mills
- Web page: https://patentgrep.com/patent/US10441689B2

## CPC

- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61B 17/7002: {Longitudinal elements, e.g. rods}
- A61L 15/22: containing macromolecular materials
- A61L 15/44: Medicaments
- A61L 27/14: Macromolecular materials
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61L 29/04: Macromolecular materials
- A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)}
- A61L 31/04: Macromolecular materials
- B29C 64/106: using only liquids or viscous materials, e.g. depositing a continuous bead of viscous material
- B29C 64/112: using individual droplets, e.g. from jetting heads
- B29C 64/118: using filamentary material being melted, e.g. fused deposition modelling [FDM]
- B29C 64/209: Heads; Nozzles
- B29C 64/25: Housings, e.g. machine housings
- B33Y 30/00: Apparatus for additive manufacturing; Details thereof or accessories therefor
- B33Y 70/10: Composites of different types of material, e.g. mixtures of ceramics and polymers or mixtures of metals and biomaterials
- A61F 2240/001: Designing or manufacturing processes
- B29L 2031/7532: {Artificial members, protheses}
- B33Y 10/00: Processes of additive manufacturing
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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
- 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)
- B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES

## Abstract

A method for manufacturing a bioactive implant including the steps of (a) forming a mixture of an bioactive agent and a setting agent capable of transitioning from a flowable state to a rigid state; (b) converting the mixture into a flowable state; and (c) transitioning the mixture into a solid state in a shape of the implant.

## Claims

### Claim 1

A method for manufacturing a bioactive implant comprising the steps of:
a. forming a mixture of at least one of an antimicrobial, an antiseptic, or a chemo-therapeutic with a polymer stock material, wherein (i) the antimicrobial, antiseptic, or chemo-therapeutic ranges from about 0.01% to about 75% by weight of the mixture, and (ii) the mixture further comprises an adhering agent enhancing the adhesion of the bioactive agent to the polymer stock material, the adhering agent being at least one from the group consisting of biological oils, silicone-based substances, and water;
b. heating the mixture to an approximate meltflow temperature of the polymer stock material; and
c. forming the mixture into a shape of a stent or a catheter using 3D printing.

### Claim 2 (depends on 1)

The method of claim 1, wherein the meltflow temperature does not substantially exceed a degradation temperature of the bioactive agent.

### Claim 3 (depends on 2)

The method of claim 2, wherein the meltflow temperature is less than about 220° C.

### Claim 4 (depends on 1)

The method of claim 1, wherein the polymer stock material is at least one from the group consisting of poly(methyl methacrylates), acrylonitrile butadiene styrene(s), polycarbonate(s), polylactides, polyglycolides, polycaprolactones, polyanhydrides, polyorthocarbonates, polyvinylpyrrolidone chitosan, and a linear polysaccharide.

### Claim 5 (depends on 1)

The method of claim 1, further comprising a second bioactive agent which is at least one from the group consisting of metals, proteins, peptides, polypeptides, sugars, carbohydrates, lipids, hormones, minerals, vitamins, and radioactive materials.

### Claim 6 (depends on 1)

The method of claim 1, further comprising the step of providing an implant and transitioning the mixture into the shape of the implant by coating the implant with the mixture.

### Claim 7

A method for manufacturing a bioactive implant comprising the steps of:
a. forming a mixture of at least one of an antimicrobial, an antiseptic, or a chemo-therapeutic with a polymer stock material, wherein (i) the antimicrobial, antiseptic, or chemo-therapeutic ranges from about 0.01% to about 75% by weight of the mixture, and (ii) the mixture further includes nanostructures from the group consisting of carbone, grapheme, halloysite, titanium, zinc nanotubes and oxidized forms thereof;
b. heating the mixture to an approximate meltflow temperature of the polymer stock material; and
c. forming the mixture into a shape of a stent or a catheter using 3D printing.

### Claim 8

A method for manufacturing a bioactive implant comprising the steps of:
a. forming a mixture of at least one of an antimicrobial, an antiseptic, or a chemo-therapeutic with a polymer stock material;
b. heating the mixture to an approximate meltflow temperature of the polymer stock material;
c. forming the mixture into a shape of a stent or a catheter using 3D printing; and
d. wherein the mixture further includes at least one mineral from the group consisting of magnesium dioxide, zinc oxide, titanium dioxide, and clay nanoparticles.

### Claim 9 (depends on 1)

The method of claim 1, wherein the antimicrobial is at least one from the group consisting of aminoglycoside, cephalosporin, macrolide, lincosamide, penicillin, Quinolone, Rifamycins, Sulfa, tetracycline, cabapenems, polypeptides and colloidal silver.

### Claim 10

A method for manufacturing a bioactive implant comprising the steps of:
a. forming a mixture of at least one of an antimicrobial, an antiseptic, or a chemo-therapeutic with a polymer stock material, wherein the antimicrobial, antiseptic, or chemo-therapeutic ranges from about 0.01% to about 75% by weight of the mixture;
b. heating the mixture to an approximate meltflow temperature of the polymer stock material; and
c. forming the mixture into a shape of a stent or a catheter using 3D printing, wherein the printing step includes printing a honeycombed structure having a void content of at least 5%.

### Claim 11 (depends on 1)

The method of claim 1, wherein the polymer stock material's temperature is reduced below the material's ductile-brittle transition temperature before the material is reduced to smaller sized components.

### Claim 12 (depends on 10)

The method of claim 10, wherein the meltflow temperature does not substantially exceed a degradation temperature of the bioactive agent.

### Claim 13 (depends on 12)

The method of claim 12, wherein the meltflow temperature is less than about 220° C.

### Claim 14 (depends on 10)

The method of claim 10, wherein the polymer stock material is at least one from the group consisting of poly(methyl methacrylates), acrylonitrile butadiene styrene(s), polycarbonate(s), polylactides, polyglycolides, polycaprolactones, polyanhydrides, polyorthocarbonates, polyvinylpyrrolidone chitosan, and a linear polysaccharide.

### Claim 15 (depends on 10)

The method of claim 10, further comprising a second bioactive agent which is at least one from the group consisting of metals, proteins, peptides, polypeptides, sugars, carbohydrates, lipids, hormones, minerals, vitamins, and radioactive materials.

### Claim 16 (depends on 7)

The method of claim 7, wherein the meltflow temperature does not substantially exceed a degradation temperature of the bioactive agent.

### Claim 17 (depends on 16)

The method of claim 16, wherein the meltflow temperature is less than about 220° C.

### Claim 18 (depends on 7)

The method of claim 7, wherein the polymer stock material is at least one from the group consisting of poly(methyl methacrylates), acrylonitrile butadiene styrene(s), polycarbonate(s), polylactides, polyglycolides, polycaprolactones, polyanhydrides, polyorthocarbonates, polyvinylpyrrolidone chitosan, and a linear polysaccharide.

### Claim 19 (depends on 7)

The method of claim 7, further comprising a second bioactive agent which is at least one from the group consisting of metals, proteins, peptides, polypeptides, sugars, carbohydrates, lipids, hormones, minerals, vitamins, and radioactive materials.