# US 9,750,839 B2 · Drug eluting medical devices

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- Number: US 9,750,839 B2
- Document ID: US9750839B2
- Status: Granted
- Kind: B2
- Application number: 13/429,482
- Filed: 2012-03-26
- Published: 2013-01-03
- Granted: 2017-09-05
- Earliest claimed: 2011-06-30
- Assignees: Covidien LP
- Applicants: Arpan Desai
- Inventors: Arpan Desai
- Web page: https://patentgrep.com/patent/US9750839B2

## CPC

- A61L 17/145: {Coating}
- A61L 17/005: {containing a biologically active substance, e.g. a medicament or a biocide}
- A61L 31/10: Macromolecular materials
- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61L 2300/258: Genetic materials, DNA, RNA, genes, vectors, e.g. plasmids
- A61L 2420/08: Coatings comprising two or more layers
- 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)

## Abstract

Medical devices possessing coatings are provided. The coatings include at least one polyelectrolyte, capable of changing the surface charge of the device to which they are applied. The polyelectrolytes permit attachment of charged bioactive agents thereto. Multiple polyelectrolytes, possessing opposite charges, may be sequentially applied to produce a medical device having multiple layers. Methods for forming such devices are also provided.

## Claims

### Claim 1

A medical device comprising:
a substrate possessing a charge;
at least a first layer comprising a polymer comprising a first polyelectrolyte in combination with at least one bioactive agent, the first polyelectrolyte possessing a charge opposite the charge on the substrate; and
at least a second layer comprising a polymer comprising a second polyelectrolyte in combination with at least one bioactive agent, the second polyelectrolyte possessing a charge opposite the charge on the first polyelectrolyte,
wherein an outer layer of the medical device comprises the first layer or second layer, and the outer layer further comprises a polymer capable of releasing its bioactive agent over a period of from about 1 second to about 6 months, with an inner layer comprising the other of the first layer or second layer under the outer layer, the inner layer formed of a polymer which releases its bioactive agent over a period of from about 30 minutes to about 2 weeks.

### Claim 2 (depends on 1)

The medical device according to claim 1, wherein the at least one layer comprising a first polyelectrolyte is disposed on the substrate.

### Claim 3 (depends on 1)

The medical device according to claim 1, wherein the at least one layer comprising a second polyelectrolyte is disposed on the at least one layer comprising the first polyelectrolyte.

### Claim 4 (depends on 1)

The medical device according to claim 1, wherein the substrate is selected from the group consisting of meshes, buttresses, tapes, felts, scaffolds, patches, pledgets, tissue reinforcements, sutures, tacks, and staples.

### Claim 5 (depends on 1)

The medical device according to claim 1, wherein the substrate comprises a material selected from the group consisting of collagen, gelatin, polypropylene and polyester.

### Claim 6 (depends on 1)

The medical device according to claim 1, wherein the substrate possesses a positive charge, the first polyelectrolyte comprises a polyanion, and the second polyelectrolyte comprises a polycation.

### Claim 7 (depends on 1)

The medical device according to claim 1, wherein the substrate possesses a negative charge, the first polyelectrolyte comprises a polycation, and the second polyelectrolyte comprises a polyanion.

### Claim 8 (depends on 1)

The medical device according to claim 1, further comprising a charged species selected from the group consisting of nanoparticles, clay platelets, glass beads, metal alloys, and combinations thereof.

### Claim 9 (depends on 1)

The medical device according to claim 1, wherein the medical device possesses from about 2 to about 30 layers comprising the first polyelectrolyte, and from 2 about 30 layers comprising the second polyelectrolyte.

### Claim 10 (depends on 9)

The medical device according to claim 9, wherein the layers comprising the first polyelectrolyte and the layers comprising the second polyelectrolyte are in an alternating configuration.

### Claim 11 (depends on 1)

The medical device according to claim 1, wherein the medical device possesses a positive charge, and the bioactive agent possesses a negative charge.

### Claim 12 (depends on 11)

The medical device according to claim 11, wherein the bioactive agent is selected from the group consisting of DNA, proteins, growth factors, and combinations thereof.

### Claim 13 (depends on 1)

The medical device according to claim 1, wherein the medical device possesses a negative charge, and the bioactive agent possesses a positive charge.

### Claim 14 (depends on 13)

The medical device according to claim 13, wherein the bioactive agent is selected from the group consisting of growth factors, drugs, and combinations thereof.

### Claim 15 (depends on 1)

A surgical buttress comprising the medical device of claim 1.

### Claim 16 (depends on 1)

A hernia mesh comprising the medical device of claim 1.

### Claim 17

A medical device comprising:
a substrate possessing a charge;
at least a first layer comprising clay platelets in combination with at least one bioactive agent, the clay platelets possessing a charge opposite the charge on the substrate;
at least a second layer comprising a polymer comprising a polyelectrolyte in combination with at least one bioactive agent, the polyelectrolyte possessing a charge opposite the charge on the clay platelets,
wherein an outer layer of the medical device comprising the first layer or second layer releases its bioactive agent over a period of from about 1 second to about 6 months, with a layer comprising the other of the first layer or second layer under the outer layer releasing its bioactive agent over a period of from about 30 minutes to about 2 weeks.

### Claim 18

A medical device comprising:
a substrate possessing a charge;
at least a first layer comprising a polymer comprising a polyelectrolyte in combination with at least one bioactive agent, the polyelectrolyte possessing a charge opposite the charge on the substrate;
at least a second layer comprising clay platelets in combination with at least one bioactive agent, the clay platelets possessing a charge opposite the charge on the polyelectrolyte,
wherein an outer layer of the medical device comprising the first layer or the second layer releases its bioactive agent over a period of from about 1 second to about 6 months, with a layer under the outer layer comprising the other of the first layer or the second layer releasing its bioactive agent over a period of from about 30 minutes to about 2 weeks.
