Device with microstructure mediated absorption profile

Patent metadata

Field	Value
Publication number	US-11857700-B2
Application number	US-202117175244-A
Country	US
Kind code	B2
Filing date	Feb 12, 2021
Priority date	Oct 18, 2017
Publication date	Jan 2, 2024
Grant date	Jan 2, 2024

Abstract

Polymer devices are disclosed with microstructured surfaces that modify their absorption pathway. Polymers which generally degrade in water by fracturing into high surface energy fragments, are modified to degrade in vivo without the formation of sharp fragments. Devices are disclosed that possess improved handling characteristics and degrade in an aqueous environment in a uniform and continuous way that favors the formation of soluble monomers rather than solid particulate. Absorbable medical implants with the disclosed surface modifications are more biocompatible, with reduced foreign body response, and dissolution into metabolizable molecular species.

First claim

What is claimed is:

1. An absorbable polymer medical implant for contacting tissue comprising:
a substrate having an inner core and an outer surface, the outer surface comprising a first plurality of microfeatures disposed on top of a second plurality of microfeatures, at least one microfeature of the plurality of second microfeatures having a height of 50 to 200 microns and a width of 50 to 200 microns;
the substrate comprising a polymer that is degradable in vivo by hydrolysis or enzymatic degradation; and
wherein the first plurality of microfeatures is hydrophilic such that when exposed to an aqueous environment, the volume of the microstructure is hydrated, and wherein the second plurality of microfeatures is hydrophobic such that when exposed to an aqueous environment, only a partial volume of the microstructure is hydrated.

2. The absorbable polymer medical implant of claim 1 , wherein at least one microfeature of the plurality of first microfeatures includes a height of 10-25 microns and a width of 1-15 microns.

3. The absorbable polymer medical implant of claim 1 , wherein the outer surface further comprises the second plurality of microfeatures disposed on top of a third plurality of microfeatures.

4. The absorbable polymer medical implant of claim 3 , wherein at least one microfeature of the plurality of third microfeatures includes a height of 100-500 microns and a width of 100-500 microns.

5. The absorbable polymer medical implant of claim 1 , wherein the outer surface and microfeatures are configured to facilitate deposition of connective tissue between at least a portion of the plurality of microfeatures when implanted.

6. The absorbable polymer medical implant of claim 1 , wherein the substrate is configured to dissolve upon implantation without particulate formation.

7. The absorbable polymer medical implant of claim 1 , wherein the substrate comprises a first discrete portion covered by the plurality of microfeatures and a second discrete portion that is not covered by the plurality of microfeatures.

8. The absorbable polymer medical implant of claim 1 , wherein the substrate is covered by the plurality of microfeatures.

9. The absorbable polymer medical implant of claim 1 , wherein the implant is absorbed in 2-3 months after implantation.

10. The absorbable polymer medical implant of claim 1 , wherein the polymer comprises a bioabsorbable material selected from the group consisting of lactide, glycolide, caprolactone, polydioxaxone, trimethylene carbonate, polyorthoesters, polyethylene oxide, and polyester polyurethane.

11. The absorbable polymer medical implant of claim 1 , wherein either of the first or second plurality of microfeatures are comprised of a polymer selected from the group consisting of ethylene vinyl acetate, polyanhydrides, polyorthoesters, lactic acid, glycoloic acid, and polyphosphazenes.

12. An absorbable polymer medical implant for contacting tissue comprising:
a substrate having an inner core and an outer surface, the outer surface comprising a first plurality of microfeatures disposed on top of a second plurality of microfeatures, at least one microfeature of the plurality of second microfeatures having a height of 50 to 200 microns and a width of 50 to 200 microns;
the substrate comprising a polymer that is degradable in vivo by hydrolysis or enzymatic degradation; and
wherein the first plurality of microfeatures is hydrophobic such that when exposed to an aqueous environment, a partial volume of the microstructure is hydrated, and wherein the second plurality of microfeatures is hydrophilic such that when exposed to an aqueous environment, the volume of the microstructure is hydrated.

13. The absorbable polymer medical implant of claim 12 , wherein at least one microfeature of the plurality of first microfeatures includes a height of 10-25 microns and a width of 1-15 microns.

14. The absorbable polymer medical implant of claim 12 , wherein the outer surface further comprises the second plurality of microfeatures disposed on top of a third plurality of microfeatures.

15. The absorbable polymer medical implant of claim 14 , wherein at least one microfeature of the plurality of third microfeatures includes a height of 100-500 microns and a width of 100-500 microns.

16. The absorbable polymer medical implant of claim 12 , wherein the outer surface and microfeatures are configured to facilitate deposition of connective tissue between at least a portion of the plurality of microfeatures when implanted.

17. The absorbable polymer medical implant of claim 12 , wherein the substrate is configured to dissolve upon implantation without particulate formation.

18. The absorbable polymer medical implant of claim 12 , wherein the substrate comprises a first discrete portion covered by the plurality of microfeatures and a second discrete portion that is not covered by the plurality of microfeatures.

19. The absorbable polymer medical implant of claim 12 , wherein the substrate is covered by the plurality of microfeatures.

20. The absorbable polymer medical implant of claim 12 , wherein the implant is absorbed in 2-3 months after implantation.

Assignees

• Bvw Holding Ag

Inventors

• Bluecher Lukas
• Kleinhenz Kenneth
• Milbocker Michael

Classifications

• A61L27/58 Primary

  Materials at least partially resorbable by the body · CPC title

• A61L27/18

  obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds · CPC title

• A61L27/22

  Polypeptides or derivatives thereof {, e.g. degradation products} · CPC title

• A61L27/34

  Macromolecular materials · CPC title

• A61L31/06

  obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)} · CPC title