# US 9,750,851 B2 · Implantable medical devices having double walled microspheres

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- Number: US 9,750,851 B2
- Document ID: US9750851B2
- Status: Granted
- Kind: B2
- Application number: 15/334,625
- Filed: 2016-10-26
- Published: 2017-02-16
- Granted: 2017-09-05
- Earliest claimed: 2010-09-10
- Assignees: University of Pittsburgh—Of the Commonwealth System of Higher Education
- Applicants: University Of Pittsburgh—Of The Commonwealth System Of Higher Education
- Inventors: Lauren Elizabeth Kokai; Kacey Gribbin Marra
- Web page: https://patentgrep.com/patent/US9750851B2

## CPC

- A61L 27/58: Materials at least partially resorbable by the body
- A61B 17/1128: {of nerves}
- A61K 9/50: Microcapsules {having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals (A61K9/2081 takes precedence; particles with a single coating comprising drug A61K9/167)}
- A61K 38/185: {Nerve growth factor [NGF]; Brain derived neurotrophic factor [BDNF]; Ciliary neurotrophic factor [CNTF]; Glial derived neurotrophic factor [GDNF]; Neurotrophins, e.g. NT-3}
- A61L 27/18: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61M 37/00: Other apparatus for introducing media into the body (for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30); Percutany, i.e. introducing medicines into the body by diffusion through the skin (salt baths A61H33/04)
- B01J 13/22: Coating
- A61K 9/0024: {Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue (compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L)}
- A61K 9/5031: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)}
- A61L 2300/414: Growth factors
- A61L 2430/32: for nerve reconstruction
- A61M 2205/04: implanted
- 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)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- B01J: CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS

## Abstract

An implantable medical device including at least one double-walled microsphere containing an active agent, and a biodegradable polymer layer containing the at least one double-walled microsphere.

## Claims

### Claim 1

A method of promoting nerve generation comprising implanting an implantable nerve guide comprising a biodegradable polymer tube having a lumen comprising:
(a) an inner layer comprising a biodegradable polymer, into which are embedded double-walled microspheres containing glial cell-line derived neurotrophic factor, wherein a poly(lactic-co-glycolic acid) layer forms a core and a poly(lactide) layer forms a shell of the double-walled microsphere and the double-walled microspheres provide sustained release of the glial cell-line derived neurotrophic factor over at least seven days in an amount effective in promoting nerve regeneration; and
(b) an outer layer comprising a biodegradable polymer without double-walled microspheres, wherein said outer layer encapsulates the inner layer.

### Claim 2 (depends on 1)

The method of promoting nerve generation of claim 1, wherein the inner layer comprising a biodegradable polymer layer comprises poly(caprolactone).

### Claim 3 (depends on 1)

The method of promoting nerve generation of claim 1, wherein the inner layer comprising a biodegradable polymer layer comprises poly(caprolactone) and the outer layer comprising a biodegradable polymer comprises poly(caprolactone).