Medical device coating with a biocompatible layer

• US 10,525,170 B2
• Filed: 12/09/2015
• Issued: 01/07/2020
• Est. Priority Date: 12/09/2014
• Status: Active Grant

• Current Assignee: Tangible Science, Llc
• Original Assignee: Tangible Science, Llc
• Inventors: Havenstrite, Karen, McCray, Victor W., Felkins, Brandon M., Cook, Paul
• Primary Examiner(s): Basquill, Sean M
• Application Number:
  US15/533,744
• Publication Number:
  US 20170360994A1
• Time in Patent Office: 1,490 Days
• CPC Class Codes: A61L 15/46 Deodorants or malodour counteractants, e.g. to inhibit the formation of ammonia or bacteria
• CPC Class Codes: A61L 15/60 Liquid-swellable gel-forming materials, e.g. super-absorbents
• CPC Class Codes: A61L 2300/104 Silver, e.g. silver sulfadiazine
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2400/12 Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

Medical devices with a hydrogel layer covalently attached to a portion of the outer surface of the medical device are provided along with methods for applying the coating. The hydrogel layer can include a first polymer species comprising polyethylene glycol (PEG) and a second polymer species. Examples of the second polymer species include PEG and polyacrylamide (PAM). The first and second species can be at least partially cross-linked. Methods for forming the hydrogel coatings on the medical devices are provided including nucleophilic conjugate reactions, such as Click reactions.

Claims

1. A medical device comprising:

an outer surface; and

a hydrogel layer covalently attached to at least a portion of the outer surface, the hydrogel layer adapted to contact a body tissue or fluid, wherein the hydrogel layer comprises a biocompatible polymer population comprising;

a first hydrophilic polymer species comprising polyethylene glycol (PEG) having between two to twelve branch arms, wherein at least a subset of the branch arms comprises a reactive sulfonyl group, and

a second hydrophilic polymer species comprising polyacrylamide having one or more pendant reactive nucleophilic groups,

wherein the reactive sulfonyl group of at least one of the subset of the branch arms of the PEG is reacted with the one or more pendant reactive nucleophilic groups of the polyacrylamide to at least partially covalently link the PEG to the polyacrylamide.

2. The device of claim 1, wherein the device is configured to be implantable within a mammalian body.

3. The device of claim 2, wherein the device is a stent configured to keep a cavity open.

4. The device of claim 3, wherein the stent is configured to keep a blood vessel, bile duct, intestine, nasal passage or cavity, sinus cavity, or intraocular channel open.

5. The device of claim 2, wherein the device is a sensor, camera, vital sign monitor, drug depot device, neurostimulator, ultrasound, silicone implant, saline implant, hernia mesh, penile implant, orthopedic rod or plate or pin or nails, pacemaker, cardiac valve, ear tube, aneurysm coil, or intraocular lens.

6. The device of claim 1, wherein the device is a test strip.

7. The device of claim 6, wherein the device is a drug, salivary, urine, blood or semen test strip.

8. The device of claim 1, wherein the device is a tool configured to be inserted within a mammalian body.

9. The device of claim 8, wherein the device is a catheter, trocar, endoscope, or laparoscope.

10. The device of claim 1, wherein the device is configured to be used externally on a mammalian body.

11. The device of claim 10, wherein the device is configured for use as a bandage, wound dressing, external sensor, hearing aid, or artificial skin.

12. The device of claim 1, wherein the outer surface of the device comprises one or more of:

glass, plastic, titanium, nitinol, polyethylene, polypropylene, polyvinyl chloride, polytetrafluoroethylene, polydimethylsiloxane, polyethylene terephthalate, polyamides, polyether urethane, polyether urethane urea, polystyrene, polycarbonate, polysulfones, polymethyl methacrylate, poly 2-hydroxyethylmethacrylate, polyvinylalcohol, polyglycolic acid, polycaprolactone, polylactic acid, polyortho ester, cellulose acetate, collagen, or silk.

13. The device of claim 1, wherein the outer surface of the device consists essentially of a material selected from the group consisting of:

glass, plastic, titanium, nitinol, polyethylene, polypropylene, polyvinyl chloride, polytetrafluoroethylene, polydimethylsiloxane, polyethylene terephthalate, polyamides, polyether urethane, polyether urethane urea, polystyrene, polycarbonate, polysulfones, polymethyl methacrylate, poly 2-hydroxyethylmethacrylate, polyvinylalcohol, polyglycolic acid, polycaprolactone, polylactic acid, polyortho ester, cellulose acetate, collagen, or silk.

14. The device of claim 1, wherein the one or more reactive nucleophilic groups is selected from the group consisting of:

amines, amino-reactive groups, sulfhydryl, sulfhydryl-reactive groups, carboxyl groups, hydroxyl groups, haloalkyl groups, dienophile groups, aldehyde or ketone groups, alkenes, epoxides, and phosphoramidites.

15. The device of claim 1, wherein the reactive sulfonyl group of a second subset of the branched arms of the PEG is covalently linked to the outer surface of the device.

16. The device of claim 1, wherein the hydrogel layer substantially surrounds the outer surface of the device.

17. The device of claim 1, wherein the hydrogel layer or the hydrogel layer and device are substantially optically clear.

18. The device of claim 1, wherein the hydrogel layer is adapted to allow optical transmission through the hydrogel layer to the device.

19. The device of claim 1, wherein the hydrogel layer is adapted to attenuate x-ray transmission.

20. The device of claim 1, wherein the hydrogel layer is adapted to enable diffusion of biologic molecules, glucose, solutes, polymers, drugs.

21. The device of claim 1, wherein the hydrogel layer comprises a thickness between about 5 nm to about 30 nm.

22. The device of claim 1, wherein the hydrogel layer comprises a thickness below about 100 nm.

23. The device of claim 1, wherein the hydrogel layer comprises a thickness less than about 50 nm.

24. The device of claim 1, wherein the hydrogel layer comprises a thickness less than about 1 micron.

25. The device of claim 1, wherein the hydrogel layer comprises a maximum thickness of about 10 microns.

26. The device of claim 1, wherein a first portion of the hydrogel layer comprises a first thickness different from a second thickness of a second portion of the hydrogel layer.

27. The device of claim 1, wherein the hydrogel layer has a lower coefficient of friction than an underlying device surface.

28. The device of claim 1, wherein the hydrogel layer has a relative protein resistance compared to an underlying device surface.

29. The device of claim 1, wherein the hydrogel layer comprises between about 80% to about 98% water by weight.