Anatomic tissue-engineered osteochondral implant and method for fabrication thereof

Patent metadata

Field	Value
Publication number	US-11633879-B2
Application number	US-202117152647-A
Country	US
Kind code	B2
Filing date	Jan 19, 2021
Priority date	Jan 21, 2020
Publication date	Apr 25, 2023
Grant date	Apr 25, 2023

Abstract

A method for forming a prosthesis comprising a bone-like portion and a cartilage-like portion can comprise additively manufacturing a first positive mold in accordance with a portion of a first three-dimensional model of a portion of a bone. A first negative mold can be formed from the first positive mold. The bone-like portion can be created within the first negative mold. A second positive mold of the bone and a cartilage can be additively manufactured from a second three-dimensional model. A portion of the second three-dimensional model can correspond to a portion of the first three-dimensional model. A second negative mold can be formed from the second positive mold. The bone-like portion can be positioned in the second negative mold so that the second negative mold and the bone-like portion can define a cartilage space that can be filled with a material to form the cartilage-like portion of the prosthesis.

First claim

What is claimed is:

1. A method for forming a prosthesis having a bone-like portion and a cartilage-like portion, the method comprising:
additively manufacturing a first positive mold in accordance with at least a portion of a first three-dimensional model of at least a portion of a bone;
forming a first negative mold from the first positive mold;
creating the bone-like portion of the prosthesis within the first negative mold;
additively manufacturing a second positive mold of the bone and a cartilage from a second three-dimensional model, wherein a portion of the second three-dimensional model corresponds to a portion of the first three-dimensional model;
forming a second negative mold from the second positive mold;
positioning the bone-like portion of the prosthesis in the second negative mold so that the second negative mold and the bone-like portion of the prosthesis cooperatively define a cartilage space; and
filling the cartilage space with a material to form the cartilage-like portion of the prosthesis.

2. The method of claim 1 , wherein forming the negative mold from the first positive mold comprises forming the first negative mold from polydimethylsiloxane (PDMS).

3. The method of claim 1 , wherein creating the bone-like portion comprises filling the first negative mold with a mixture comprising polycaprolactone (PCL) dissolved in chloroform and allowing the chloroform to evaporate from the mixture.

4. The method of claim 3 , wherein the mixture further comprises sodium chloride crystals, wherein the method further comprises soaking the bone-like portion of the prosthesis in water to dissolve the salt crystals.

5. The method of claim 4 , wherein the salt crystals have a major dimension that ranges from 100 to 300 micrometers.

6. The method of claim 1 , wherein the bone-like portion contains a bone-promoting factor.

7. The method of claim 1 , wherein filling the cartilage space with the material to form the cartilage-like portion of the prosthesis comprises filling the cartilage space with hydrogel, and irradiating the material to crosslink the hydrogel.

8. The method of claim 7 , wherein the hydrogel comprises methacrylated hyaluronic acid (meHA).

9. The method of claim 7 , wherein the hydrogel is cell-laden.

10. The method of claim 9 , wherein the hydrogel is cell-laden with between 10 million and 100 million cells per milliliter of hydrogel.

11. The method of claim 1 , wherein each of the first three dimensional model and the second three-dimensional model is created from an image of the at least a portion of the bone, wherein the image is captured with one of a computed tomography (CT) scan, magnetic resonance imaging (MRI), or a laser scan of an ex vivo sample.

12. The method of claim 11 , wherein the image is captured with the laser scan of the ex vivo sample, wherein the bone is soaked in a solution to enhance cartilage contrast.

13. The method of claim 11 , further comprising:
creating, based on the image of the bone and using at least one processor, the first three-dimensional model of the at least a portion of the bone; and
creating, based on the image of the bone and using the at least one processor, the second three-dimensional model of the at least a portion of the bone and cartilage thereon.

14. The method of claim 13 , wherein each of the first three-dimensional model and the second three-dimensional model is a surface mesh.

15. The method of claim 14 , wherein each of the first three-dimensional model and the second three-dimensional model is provided as a .STL file.

16. The method of claim 13 , wherein creating the first three-dimensional model comprises using an edge collapse decimation to reduce a number of faces of the surface mesh of the first three-dimensional model.

17. The method of claim 13 , wherein creating the first three-dimensional model of the at least a portion of the bone comprises applying a Laplacian smoothing to the first three-dimensional model.

18. The method of claim 13 , wherein the bone defines a volume, wherein creating the first three-dimensional model of the at least a portion of the bone comprises deleting vertices of the surface mesh that, if the surface mesh and the bone were overlaid at a 1:1 scale, would be positioned within the volume of the bone.

19. The method of claim 13 , wherein creating the first three-dimensional model of the at least a portion of the bone comprises editing the surface mesh of the first three-dimensional model to remove any clinical damage of the bone.

20. The method of claim 19 , wherein the clinical damage of the bone comprises a hole or an osteophyte.

21. The method of claim 13 , wherein creating the first three-dimensional model of the at least a portion of the bone comprises forming a fixation keel.

22. The method of claim 13 , wherein the bone has a shape, the method further comprising:
cutting the bone to remove a portion thereof and leave a remaining portion of the bone,
wherein creating the first three-dimensional model of the at least a portion of the bone comprises modifying an end of the first three-dimensional model so that the prosthesis formed from the first three-dimensional model cooperates with the remaining portion of the bone to form a coupled prosthesis having a shape matching the shape of the bone.

23. The method of claim 13 , wherein creating the second three-dimensional model of the at least a portion of the bone and cartilage thereon comprises translating a first portion of the surface mesh of the first three-dimensional model away from an opposing second portion of the surface mesh of the first three-dimensional model along an axis.

24. The method of claim 23 , wherein translating the first portion of the surface mesh away from the second portion of the surface mesh along the axis comprises translating the first portion by between 0.25 mm and 1 mm.

25. The method of claim 1 , wherein the bone is a carpal bone.

Assignees

• Us Gov Veterans Affairs
• Univ Pennsylvania

Inventors

• Stoeckl Brendan D
• Mauck Robert L
• Zlotnick Hannah
• Farrell Megan
• Miller Liane
• Steinberg David

Classifications

• A61F2002/4271

  Carpal bones · CPC title

• B29L2031/7532

  Artificial members, protheses · CPC title

• A61L27/26

  Mixtures of macromolecular compounds · CPC title

• B29C2033/385

  by laminating a plurality of layers · CPC title

• A61L2430/02

  for reconstruction of bones; weight-bearing implants · CPC title