# US 10,117,970 B2 · Local delivery of water-soluble or water-insoluble therapeutic agents to the surface of body lumens

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- Number: US 10,117,970 B2
- Document ID: US10117970B2
- Status: Granted
- Kind: B2
- Application number: 15/471,579
- Filed: 2017-03-28
- Published: 2017-08-10
- Granted: 2018-11-06
- Earliest claimed: 2008-09-15
- Assignees: The Spectranetics Corporation
- Applicants: The Spectranetics Corporation
- Inventors: Eugene T. Michal; Matthew J. Pollman
- Web page: https://patentgrep.com/patent/US10117970B2

## CPC

- A61L 29/085: {Macromolecular materials}
- A61K 31/337: having four-membered rings, e.g. taxol
- A61L 29/148: {Materials at least partially resorbable by the body}
- A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)}
- A61L 33/0005: {Use of materials characterised by their function or physical properties}
- A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00})
- A61M 25/1027: {Making of balloon catheters}
- A61L 2300/204: with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
- A61L 2300/416: Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
- A61L 2400/00: Materials characterised by their function or physical properties
- A61L 2420/06: Coatings containing a mixture of two or more compounds
- A61M 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes}
- A61M 2025/1075: {having a balloon composed of several layers, e.g. by coating or embedding}
- A61M 2025/1081: {having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths}
- A61M 2025/109: {having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow}
- 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)
- 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)}

## Abstract

A method and device for local delivery of a water-insoluble therapeutic agent to the tissue of a normal or diseased body lumen is disclosed. An expandable structure of a medical disposable device, such as a balloon of a balloon catheter, is coated with a non-durable coating which comprises poly(HEMA) complexed with iodine and has a substantially water-insoluble therapeutic agent dispersed therein. The medical disposable device is inserted into a body lumen, and expanded to contact the non-durable coating against the body lumen and deliver the substantially water-insoluble therapeutic agent to the body lumen tissue.

## Claims

### Claim 1

A catheter assembly comprising:
an expandable structure having an outer surface;
a non-durable coating disposed on the outer surface of the expandable structure, the non-durable coating including a plasticizer in combination with poly(hydroxyethyl methacrylic) acid complexed with iodine; and
a substantially water-insoluble therapeutic agent dispersed in the non-durable coating.

### Claim 2 (depends on 1)

The catheter assembly of claim 1, wherein the plasticizer includes propylene glycol, triethyl citrate, glycerol, or dibutyl sebacate.

### Claim 3 (depends on 1)

The catheter assembly of claim 1, wherein the poly(hydroxyethyl methacrylic) acid has a number average molecular weight below 8 KD.

### Claim 4 (depends on 1)

The catheter assembly of claim 1, wherein the poly(hydroxyethyl methacrylic) acid is co-polymerized with a monomer including glycidyl methacrylate or acrylic acid.

### Claim 5 (depends on 1)

The catheter assembly of claim 1, wherein the substantially water-insoluble therapeutic agent includes anti-proliferative agents, anti-platelet agents, anti-inflammatory agents, anti-thrombotic agents, or thrombolytic agents.

### Claim 6 (depends on 1)

The catheter assembly of claim 1, wherein the substantially water-insoluble therapeutic agent is paclitaxel.

### Claim 7

A catheter assembly comprising:
an expandable structure having an outer surface;
a non-durable coating disposed on the outer surface of the expandable structure, the non-durable coating including a plasticizer in combination with poly(hydroxyethyl methacrylic) acid; and
a substantially water-insoluble therapeutic agent and non-covalently bound iodine dispersed throughout the non-durable coating.

### Claim 8 (depends on 7)

The catheter assembly of claim 7, wherein the plasticizer includes propylene glycol, triethyl citrate, glycerol, or dibutyl sebacate.

### Claim 9 (depends on 7)

The catheter assembly of claim 7, wherein the poly(hydroxyethyl methacrylic) acid has a number average molecular weight below 8 KD.

### Claim 10 (depends on 7)

The catheter assembly of claim 7, wherein the poly(hydroxyethyl methacrylic) acid is co-polymerized with a monomer including glycidyl methacrylate or acrylic acid.

### Claim 11 (depends on 7)

The catheter assembly of claim 7, wherein the substantially water-insoluble therapeutic agent includes anti-proliferative agents, anti-platelet agents, anti-inflammatory agents, anti-thrombotic agents, or thrombolytic agents.

### Claim 12 (depends on 7)

The catheter assembly of claim 7, wherein the substantially water-insoluble therapeutic agent is paclitaxel.