3-D PRINTING OF POROUS IMPLANTS

• US 20180296343A1
• Filed: 04/18/2017
• Published: 10/18/2018
• Est. Priority Date: 04/18/2017
• Status: Abandoned Application

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Wei, Guobao
• Application Number:
  US15/490,380
• Publication Number:
  US 20180296343A1
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/2846 Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006
• CPC Class Codes: A61F 2/30942 for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2002/0081 directly machined on the prosthetic surface, e.g. holes, grooves A61F2/30771 takes precedence
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30588 filled with solid particles
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30948 using computerized tomography, i.e. CT scans
• CPC Class Codes: A61F 2002/30952 using CAD-CAM techniques or NC-techniques
• CPC Class Codes: A61F 2002/30962 using stereolithography
• CPC Class Codes: A61F 2002/3097 using laser
• CPC Class Codes: A61F 2002/30971 Laminates, i.e. layered products
• CPC Class Codes: A61F 2002/30985 using three dimensional printing [3DP]
• CPC Class Codes: A61F 2310/00041 Magnesium or Mg-based alloys
• CPC Class Codes: A61F 2310/00359 Bone or bony tissue
• CPC Class Codes: B29C 64/106 using only liquids or viscous materials, e.g. depositing a continuous bead of viscous material
• CPC Class Codes: B29C 64/241 for rotary motion
• CPC Class Codes: B29C 64/386 : Data acquisition or data processing for additive manufacturing
• CPC Class Codes: B29K 2995/006 : Bio-degradable, e.g. bioabsorbable, bioresorbable or bioerodible
• CPC Class Codes: B29L 2031/7532 : Artificial members, protheses
• CPC Class Codes: B33Y 10/00 : Processes of additive manufacturing
• CPC Class Codes: B33Y 50/00 : Data acquisition or data processing for additive manufacturing
• CPC Class Codes: B33Y 50/02 : for controlling or regulating additive manufacturing processes
• CPC Class Codes: B33Y 70/00 : Materials specially adapted for additive manufacturing
• CPC Class Codes: B33Y 70/10 : Composites of different types of material, e.g. mixtures of ceramics and polymers or mixtures of metals and biomaterials
• CPC Class Codes: B33Y 80/00 : Products made by additive manufacturing

Abstract

Computer implemented methods of producing a porous implant are provided including obtaining a 3-D image of an intended tissue repair site; generating a 3-D digital model of the porous implant based on the 3-D image of the intended tissue repair site. The method also includes determining an implant material and an amount of a porogen to add to an implant material to obtain a desired porosity of the porous implant. The desired porosity is based on a combination of macropores, micropores and/or nanopores structures. The 3-D digital model developed is stored on a database coupled to a processor, wherein the processor has instructions for combining the implant material with the porogen based on the stored 3-D digital model and for instructing a 3-D printer to produce the porous implant. A layered 3-D printed porous implant prepared by the computer implemented method is also provided.

Claims

1. A computer implemented method for producing a porous implant, the method comprising:

obtaining a 3-D image of an intended tissue repair site;

generating a 3-D digital model of the porous implant based on the 3-D image of the intended tissue repair site, the 3-D digital model of the porous implant being configured to fit within the tissue repair site;

determining an implant material and an amount of a porogen to add to an implant material to obtain a desired porosity of the porous implant based on the 3-D digital model of the porous implant, the porosity being based on a plurality of macropores, micropores, nanopores structures or a combination thereof;

storing the 3-D digital model on a database coupled to a processor, the processor having instructions for combining the implant material with the porogen based on the stored 3-D digital model and for instructing a print surface of a 3-D printer to rotate and produce the porous implant by printing the porous implant on the rotating print surface.

2. The computer implemented method of claim 1, wherein (i) the porogen is a gas, liquid or solid;

(ii) the plurality of macropores have a pore diameter greater than about 100μ

, the plurality of micropores have the pore diameter below about 10μ and

the plurality of nanopores have the pore diameter of about 1 nm;

or (iii) the porogen is spheroidal, cuboidal, rectangular, elongated, tubular, fibrous, disc-shaped, platelet-shaped, polygonal or a mixture thereof.

3. The computer implemented method of claim 1, further comprising (i) removing the porogen prior to implantation of the porous implant at the intended tissue repair site or (ii) removing the porogen after implantation of the porous implant at the intended tissue repair site.

4. The computer implemented method of claim 2, wherein the porogen is (i) carbon dioxide, nitrogen, argon or air;

or (ii) polysaccharides comprising cellulose, starch, amylase, dextran, poly(dextrose), glycogen, poly(vinylpyrollidone), pullulan, poly(glycolide), poly(lactide), poly(lactide-co-glycolide);

(iii) sodium chloride, sugar, hydroxyapatite or polyethylene oxide, polylactic acid, polycaprolactone;

(iv) a peptide or protein;

or (v) a parathyroid hormone.

5. The computer implemented method of claim 1, wherein (i) the intended tissue repair site is a bone repair site, an osteochondral defect site, an articular cartilage defect site or a combination thereof;

(ii) the implant material comprises a carrier material and a bone material;

or (iii) the implant material comprises a natural material, a biodegradable carrier and a growth factor.

6. The computer implemented method of claim 5, wherein the carrier material comprises a metal, a biodegradable polymer or a combination thereof, and the bone material comprises mineralized or demineralized bone.

7. The computer implemented method of claim 5, wherein the carrier material is a biodegradable polymer comprising poly(L-lactide-co-D,L-lactide), polyglyconate, poly(arylates), poly(anhydrides), poly(hydroxy acids), polyesters, poly(ortho esters), poly(alkylene oxides), polycarbonates, poly(propylene fumarates), poly(propylene glycol-co fumaric acid), poly(caprolactones), polyamides, polyesters, polyethers, polyureas, polyamines, polyamino acids, polyacetals, poly(orthoesters), poly(pyrolic acid), poly(glaxanone), poly(phosphazenes), poly(organophosphazene), polylactides, polyglycolides, poly(dioxanones), polyhydroxybutyrate, polyhydroxyvalyrate, poly hydroxy-butyrate/valerate copolymers, poly (vinyl pyrrolidone), polycyanoacrylates, polyurethanes, polysaccharides or a combination thereof.

8. The computer implemented method of claim 5, wherein the bone material comprises autograft, allograft, demineralized bone matrix fiber, demineralized bone chips or a combination thereof.

9. The computer implemented method of claim 5, wherein the bone material comprises (i) fully demineralized bone fibers and surface demineralized bone chips;

or (ii) fully demineralized bone matrix fibers and surface demineralized bone chips in a ratio of from about 25;

75 to about 75;

25.

10. The computer implemented method of claim 6, wherein the porous implant comprises from about 10% to about 80% by weight of porogen, from about 20% to about 90% by weight of the polymer and from about 30% to about 50% by weight of bone material.

11. The computer implemented method according to claim 1, wherein the implant material further comprises a drug, a growth factor, a protein or a combination thereof.

12. The computer implemented method according to claim 1, wherein the implant material further comprises (i) an inorganic polymer;

(ii) soft tissue particles comprises cartilage particles;

or (iii) inorganic particles comprise hydroxy apatite, calcium HA, carbonated calcium HA, betatricalcium phosphate (beta-TCP), alpha-tricalcium phosphate (alpha-TCP), hydroxyapatite, amorphous calcium phosphate (ACP), octacalcium phosphate (OCP), tetracalcium phosphate, biphasic calcium phosphate (BCP), anhydrous dicalcium phosphate (DCPA), dicalcium phosphate dihydrate (DCPD), anhydrous monocalcium phosphate (MCPA), monocalcium phosphate monohydrate (MCPM), synthetic calcium phosphate ceramic or combinations thereof.

13. The computer implemented method of claim 1, wherein the 3-D image of an intended porous implant site is a computed tomography image of an unhealthy bone tissue repair site based on a computed tomography image of a healthy tissue repair site.

14. The computer implemented method of claim 1, wherein the 3-D image is obtained from (i) one or more X-ray images;

(ii) a computer aided design (CAD) program;

(iii) a cone beam imaging device;

(iv) a computed tomography (CT) scan device;

or (v) a magnetic resonance imaging (MRI).

15. A computer implemented method for producing a porous implant, the method comprising:

obtaining a 3-D image of an intended tissue repair site;

generating a 3D digital model of the porous implant based on the 3-D image of the intended tissue repair site, the 3-D digital model of the porous implant being configured to fit within the tissue repair site;

determining an amount of an implant material and a porogen to add to the implant material to obtain a desired porosity of the porous implant based on the 3-D digital model of the porous implant, the porosity being based on a plurality of macropores, micropores, nanopores structures or a combination thereof;

storing the 3-D digital model of the digital model on a database coupled to a processor, the processor having instructions for combining the implant material with the porogen based on the stored 3-D digital model and for instructing a print surface of a 3-D printer to rotate and produce the porous implant by printing the porous implant on the rotating print surface and removing the porogen prior to implantation of the porous implant at the intended tissue repair site.

16. A layered 3-D printed porous implant, the layered porous implant comprising:

(i) a first layer of implant material;

a second layer of porogen disposed on the first layer of implant material;

a third layer of implant material disposed on the second layer, each layer repeating until a 3-D printer has completed the porous implant;

or (ii) a first layer of implant material mixed with porogen;

a second layer of implant material mixed with porogen, the second layer disposed on the first layer;

a third layer of implant material mixed with porogen, the third layer disposed on the second layer, each layer repeating until the 3-D printer has completed the porous implant, wherein each layer is configured to be printed on a rotating print surface of the 3-D printer.

17. A layered 3-D printed porous implant of claim 16, wherein (i) the porogen is a gas, liquid or solid;

(ii) the porous implant comprises macropores that have a pore diameter greater than about 100μ

, micropores that have a pore diameter below about 10μ and

nanopores that have a pore diameter of about 1 nm;

or (iii) the porogen is spheroidal, cuboidal, rectangular, elongated, tubular, fibrous, disc-shaped, platelet-shaped, polygonal or a mixture thereof.

18. A layered 3-D printed porous implant of claim 16, wherein the porogen is (i) carbon dioxide, nitrogen, argon or air;

(ii) polysaccharides comprising cellulose, starch, amylose, dextran, poly(dextrose), glycogen, poly(vinylpyrollidone), pullulan, poly(glycolide), poly(lactide), poly(lactide-co-glycolide;

(iii) sodium chloride, sugar, hydroxyapatite or polyethylene oxide, polylactic acid, polycaprolactone;

(iv) a peptide or protein;

or (v) a parathyroid hormone.

19. A layered 3-D printed porous implant of claim 16, wherein (i) the implant material comprises a carrier material and a bone material;

or (ii) the implant material comprises a natural material, a biodegradable carrier and a growth factor.

20. A layered 3-D printed porous implant of claim 16, wherein the carrier material comprises a metal, a biodegradable polymer or a combination thereof and the bone material comprises mineralized or demineralized bone.