# US 2019/0171098 A1 · Drug delivery system and method of manufacturing thereof

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 2019/0171098 A1
- Document ID: US20190171098A1
- Status: Published application
- Kind: A1
- Application number: 16/273,013
- Filed: 2019-02-11
- Published: 2019-06-06
- Earliest claimed: 2010-08-23
- Assignees: Exogenesis Corporation
- Applicants: Exogenesis Corporation
- Inventors: Sean R. Kirkpatrick; Richard C. Svrluga; Stephen M. Blinn
- Web page: https://patentgrep.com/patent/US20190171098A1

## CPC

- G03F 1/80: Etching
- A61F 2/00: Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents (dental prostheses A61C13/00; artificial kidneys A61M1/14; artificial hearts A61M60/00)
- A61L 27/303: {Carbon}
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61L 31/084: {Carbon; Graphite}
- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- G03F 1/82: Auxiliary processes, e.g. cleaning or inspecting
- H01J 37/05: Electron or ion-optical arrangements for separating electrons or ions according to their energy {or mass}(particle separator tubes H01J49/00)
- H01J 37/147: Arrangements for directing or deflecting the discharge along a desired path ({H01J37/045 take precedence;} lenses H01J37/10)
- H01J 37/317: for changing properties of the objects or for applying thin layers thereon, e.g. for ion implantation (H01J37/36 takes precedence)
- H01J 37/3171: {for ion implantation}
- H01J 37/3178: {for applying thin layers on objects}
- H05H 3/02: Molecular or atomic-beam generation, e.g. resonant beam generation
- H10P 14/6336: {in the presence of a plasma [PECVD]}
- H10P 14/6902: {composed of carbon, e.g. alpha-C, diamond or hydrogen doped carbon}
- H10P 30/204: {into Group IV semiconductors}
- H10P 30/208: {of electrically inactive species}
- H10P 30/21: {of electrically active species}
- H10P 30/224: {of a cluster, e.g. using a gas cluster ion beam}
- H10P 50/282: {of inorganic materials}
- H10P 50/283: {by chemical means}
- A61F 2/0077: {Special surfaces of prostheses, e.g. for improving ingrowth (A61F2/30767 takes precedence)}
- A61F 2/82: Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents (stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07)
- A61F 2250/0067: Means for introducing or releasing pharmaceutical products into the body
- A61K 9/703: {characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches}
- A61L 2300/602: Type of release, e.g. controlled, sustained, slow
- A61L 2300/608: having two or more layers
- A61L 2420/02: Methods for coating medical devices
- B24B 37/04: designed for working plane surfaces
- H01J 2237/0041: Neutralising arrangements
- H01J 2237/0812: Ionized cluster beam [ICB] sources
- H01J 2237/15: Means for deflecting or directing discharge
- H01J 2237/31732: Depositing thin layers on selected microareas
- H10D 62/60: Impurity distributions or concentrations
- Y10T 428/24355: Continuous and nonuniform or irregular surface on layer or component [e.g., roofing, etc.]
- Y10T 428/24479: including variation in thickness
- Y10T 428/30: Self-sustaining carbon mass or layer with impregnant or other layer
- G03F: PHOTOMECHANICAL PRODUCTION OF TEXTURED OR PATTERNED SURFACES, e.g. FOR PRINTING, FOR PROCESSING OF SEMICONDUCTOR DEVICES; MATERIALS THEREFOR; ORIGINALS THEREFOR; APPARATUS SPECIALLY ADAPTED THEREFOR; (phototypographic composing devices B41B; photosensitive materials or processes for photographic purposes G03C; electrophotography, sensitive layers or processes therefor G03G)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- 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)
- H01J: ELECTRIC DISCHARGE TUBES OR DISCHARGE LAMPS (spark-gaps H01T; electric arc lamps H05B31/00; particle accelerators H05H)
- H05H: PLASMA TECHNIQUE (apparatus or processes specially adapted for producing X-rays H05G2/00); PRODUCTION OF ACCELERATED ELECTRICALLY-CHARGED PARTICLES OR OF NEUTRONS; PRODUCTION OR ACCELERATION OF NEUTRAL MOLECULAR OR ATOMIC BEAMS
- H10P: GENERIC PROCESSES OR APPARATUS FOR THE MANUFACTURE OR TREATMENT OF DEVICES COVERED BY CLASS H10
- 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)
- B24B: MACHINES, DEVICES, OR PROCESSES FOR GRINDING OR POLISHING (grinding of gear teeth B23F, of screw-threads B23G1/36; by electro-erosion B23H; abrasive or related blasting B24C; tools for grinding, buffing or sharpening B24D; polishing compositions C09G1/00; abrasives C09K3/14; electrolytic etching or polishing C25F3/00; grinding arrangements for use on assembled railway tracks E01B31/17); DRESSING OR CONDITIONING OF ABRADING SURFACES; FEEDING OF GRINDING, POLISHING, OR LAPPING AGENTS
- H10D: INORGANIC ELECTRIC SEMICONDUCTOR DEVICES
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

An apparatus and method provides a drug layer formed on a surface region of a medical device, the drug layer comprised of a drug deposition and a carbonized or densified layer formed from the drug deposition by irradiation on an outer surface of the drug deposition, wherein the carbonized or densified layer does not penetrate through the drug deposition and is adapted to release drug from the drug deposition at a predetermined rate.

## Claims

### Claim 1

A drug delivery system, comprising:
a medical device having at least one surface region; and
a drug layer formed on the at least one surface region, the drug layer comprised of a drug deposition on the at least one surface region and a carbonized or densified layer formed from the drug deposition by irradiation on an outer surface of the drug deposition, wherein the carbonized or densified layer does not penetrate through the drug deposition and is adapted to release drug from the drug deposition at a predetermined rate.

### Claim 2 (depends on 1)

The drug delivery system of claim 1, wherein the drug deposition does not include any polymers.

### Claim 3 (depends on 1)

The drug delivery system of claim 1, wherein the drug deposition is encapsulated between the carbonized or densified layer and the at least one surface region.

### Claim 4 (depends on 1)

The drug delivery system of claim 1, further comprising at least one additional drug layer formed on the first said drug layer, the additional drug layer comprised of an additional drug deposition and an additional carbonized or densified layer formed from the additional drug deposition by irradiation on an outer surface of the additional drug deposition.

### Claim 5 (depends on 1)

The drug delivery system of claim 1, wherein the at least one surface region is a previously applied drug layer.

### Claim 6 (depends on 1)

The drug delivery system of claim 1, wherein the irradiation is gas-cluster ion beam irradiation.

### Claim 7 (depends on 1)

The drug delivery system of claim 1, wherein the irradiation is Neutral Beam irradiation derived from a gas-cluster ion beam.

### Claim 8 (depends on 1)

The drug delivery system of claim 1, wherein the medical device is an implantable medical device.

### Claim 9

A method of providing a drug delivery system, comprising the steps of:
providing a medical device having at least one surface region; depositing a drug layer on the at least one surface region; and
forming a carbonized or densified layer on an outer surface of the drug layer by irradiating the outer surface of the drug layer with a Neutral Beam derived from a gas-cluster ion beam, wherein the carbonized or densified layer does not penetrate the drug layer and is adapted to release drug from the drug layer at a predetermined rate.

### Claim 10 (depends on 9)

The method of claim 9, further comprising the steps of depositing at least one additional drug layer on the first said carbonized or densified layer and forming an additional carbonized or densified layer on an outer surface of the at least one additional drug layer by irradiating an outer surface of the at least one additional drug layer.

### Claim 11 (depends on 9)

The method of claim 9, wherein the step of depositing includes using drug substances without any polymer material.

### Claim 12 (depends on 9)

The method of claim 9, wherein the at least one surface region is a previously applied drug layer.

### Claim 13 (depends on 9)

The method of claim 9, wherein the step of forming encapsulates the drug layer.

### Claim 14 (depends on 9)

The method of claim 9, wherein the irradiating makes use of a gas-cluster ion beam.