# US 7,744,928 B2 · Methods and compositions for treatment of lesioned sites of body vessels

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- Number: US 7,744,928 B2
- Document ID: US7744928B2
- Status: Granted
- Kind: B2
- Application number: 11/404,233
- Filed: 2006-04-14
- Published: 2007-10-18
- Granted: 2010-06-29
- Earliest claimed: 2006-04-14
- Assignees: Advanced Cardiovascular Systems, Inc.
- Inventors: Florian Niklas Ludwig; Stephen Pacetti; Paul Consigny
- Web page: https://patentgrep.com/patent/US7744928B2

## CPC

- A61K 33/00: Medicinal preparations containing inorganic active ingredients
- A61K 9/00: Medicinal preparations characterised by special physical form {(nuclear magnetic resonance contrast preparations or magnetic resonance imaging contrast preparations A61K49/18; preparations containing radioactive substances A61K51/12)}
- A61K 31/198: Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00)
- A61K 38/005: {Enzyme inhibitors (protease inhibitors A61K38/55)}
- A61K 38/44: Oxidoreductases (1)
- A61L 27/38: {containing added animal cells (organs or tissue containing native cells A61L27/36)}
- A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)}
- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61L 2300/40: characterised by a specific therapeutic activity or mode of action
- 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)
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Methods and compositions for inducing apoptosis of cells, such as macrophages, at a lesioned site of a body vessel are disclosed herein. Nitric oxide can be directly or indirectly delivered to a treatment site to increase macrophage apoptosis. Delivery can include site specific delivery of nitric oxide gas, nitric oxide in aqueous solution or a substance(s) which releases nitric oxide or causes nitric oxide to be generated from an endogenous source. Delivery can be achieved by a delivery system such as a catheter assembly, stent or other suitable device.

## Claims

### Claim 1

A method for treating a lesioned site in a body vessel comprising:
supplying a nitric oxide source comprising a nitric oxide in a gaseous state to a delivery cannula; and
delivering through the delivery cannula to a treatment site within a lumen of a body vessel the nitric oxide source.

### Claim 2 (depends on 1)

The method of claim 1, wherein the nitric oxide source comprises sufficient nitric oxide to induce cell apoptosis.

### Claim 3 (depends on 2)

The method of claim 2, wherein the cell is a macrophage cell.

### Claim 4 (depends on 1)

The method of claim 1, wherein the nitric oxide source is delivered via a carrier.

### Claim 5 (depends on 4)

The method of claim 4, wherein the carrier is selected from the group consisting of a polymeric implantable medical device, microspheres, nanoparticles, a gel, a gel depot, a polymer, a polymer depot, a hydrogel and a hydrogel depot.

### Claim 6 (depends on 4)

The method of claim 4, wherein the carrier further includes one of an enzyme or a reducing agent.

### Claim 7 (depends on 6)

The method of claim 6, wherein the enzyme is nitric oxide synthase.

### Claim 8 (depends on 6)

The method of claim 6, wherein the reducing agent is selected from the group consisting of sodium iodide, dithiothreitol, mercaptoethanol, iron particles, sodium sulfide, sodium dithionite and sodium metabisulfite.

### Claim 9 (depends on 4)

The method of claim 4, wherein the carrier is water permeable.

### Claim 10 (depends on 1)

The method of claim 1, further comprising delivering a second substance that is selected from the group consisting of arginase inhibitor, antisense and small interfering ribonucleic acid.

### Claim 11 (depends on 1)

The method of claim 1, wherein the delivery cannula is a component of a catheter device.

### Claim 12 (depends on 11)

The method of claim 11, wherein the catheter device comprises a balloon and prior to delivering the nitric oxide source, the method comprises inflating the balloon at a point proximal to the treatment site.

### Claim 13 (depends on 11)

The method of claim 11, wherein the catheter device comprises a first balloon and a second balloon and prior to delivering the nitric oxide source, the method comprises inflating the first balloon at a point proximal to the treatment site and inflating the second balloon at a point distal to the treatment site.