# US 8,147,540 B2 · Taxane coatings for implantable medical devices

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- Number: US 8,147,540 B2
- Document ID: US8147540B2
- Status: Granted
- Kind: B2
- Application number: 12/984,733
- Filed: 2011-01-05
- Published: 2011-06-23
- Granted: 2012-04-03
- Earliest claimed: 2006-03-10
- Assignees: Cook Medical Technologies LLC
- Inventors: Priscilla Reyes; William F. Moore; Patrick H. Ruane; Darin G. Schaeffer; Melinda S. Morrell
- Web page: https://patentgrep.com/patent/US8147540B2

## CPC

- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61F 2/91: made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
- A61F 2/915: with bands having a meander structure, adjacent bands being connected to each other
- A61K 31/337: having four-membered rings, e.g. taxol
- A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)}
- A61L 31/08: Materials for coatings
- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61F 2002/91533: {characterised by the phase between adjacent bands}
- A61F 2002/91575: {connected peak to trough}
- A61F 2230/0054: V-shaped
- A61F 2250/0067: Means for introducing or releasing pharmaceutical products into the body
- A61F 2310/0097: Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
- A61L 2300/416: Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
- A61L 2300/606: Coatings
- 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)
- 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)
- 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)

## Abstract

This disclosure relates to implantable medical devices coated with a taxane therapeutic agent, such as paclitaxel, in one or more solid form(s) having varying dissolution rates. Particularly preferred coatings comprise amorphous and/or solvated solid forms of taxane therapeutic agents that provide durable coatings that release the taxane over a desired period of time, which can be varied in the absence of a polymer by selecting the type and amount of solid forms of the taxane therapeutic agent in the coating. Other preferred embodiments relate to methods of coating medical devices and methods of treatment. The coatings can provide a sustained release of the taxane therapeutic agent within a body vessel without containing a polymer to achieve the desired rate of paclitaxel elution.

## Claims

### Claim 1

A method of delivering a taxane therapeutic agent to a body vessel of a patient comprising:
inserting a coated implantable device into the body vessel, wherein the coated implantable device comprises at least one surface having a coating comprising
the taxane therapeutic agent in a first taxane solid form characterized by a vibrational spectrum comprising at least two peaks between 1735 and 1705 cm−1 and a solubility of less than 20% wt. after 24 hours in porcine serum at 37° C., and in a second taxane solid form characterized by a vibrational spectrum comprising one peak between 1735 and 1705 cm−1 and a solubility of greater than 50% wt. after 24 hours in porcine serum at 37° C., wherein at least 10% of the taxane therapeutic agent is present in the first taxane solid form
positioning the coated implantable device within the body vessel; and
radially expanding the coated implantable device within the body vessel so as to place the coated implantable device in contact with a portion of a wall of the body vessel in a manner effective to deliver at least a portion of the taxane therapeutic agent to the wall of the body vessel.

### Claim 2 (depends on 1)

The method of claim 1, wherein the taxane therapeutic agent is paclitaxel.

### Claim 3 (depends on 2)

The method of claim 2, wherein the second taxane solid form is amorphous paclitaxel.

### Claim 4 (depends on 2)

The method of claim 2, wherein the first taxane solid form is dihydrate paclitaxel.

### Claim 5 (depends on 1)

The method of claim 1, wherein the coated implantable device is a radially expandable vascular stent.

### Claim 6 (depends on 1)

The method of claim 1, wherein the coated implantable device is a balloon catheter.

### Claim 7 (depends on 1)

The method of claim 1, wherein the coating comprises at least two layers, wherein each layer comprises at least one of the first taxane solid form and the second taxane solid form.

### Claim 8 (depends on 1)

The method of claim 1, wherein the coating is free of a polymer.

### Claim 9 (depends on 1)

The method of claim 1, wherein the body vessel is a vascular vessel.

### Claim 10 (depends on 9)

The method of claim 9, wherein the vascular vessel is a peripheral vessel.

### Claim 11 (depends on 9)

The method of claim 9, wherein the vascular vessel is a coronary vessel.

### Claim 12

A method of delivering a taxane therapeutic agent to a vascular vessel of a patient comprising:
inserting a coated implantable device into the vascular vessel using a means for intralumenal delivery, wherein the coated implantable device comprises at least one surface having a coating comprising
the taxane therapeutic agent in a first taxane solid form, wherein the first taxane solid form is dihydrate paclitaxel, and in a second taxane solid form, wherein the second taxane solid form is amorphous paclitaxel, wherein at least 10% of the taxane therapeutic agent is present in the first taxane solid form,
positioning the coated implantable device within the vascular vessel; and
radially expanding the coated implantable device within the vascular vessel so as to place the coated implantable device in contact with a portion of a wall of the vascular vessel in a manner effective to deliver at least a portion of the taxane therapeutic agent to the wall of the vascular vessel
wherein the coated implantable device is a radially expandable vascular stent or a balloon catheter.

### Claim 13 (depends on 12)

The method of claim 12, wherein the vascular vessel is a peripheral vessel.

### Claim 14 (depends on 12)

The method of claim 12, wherein the vascular vessel is a coronary vessel.

### Claim 15

A coated implantable medical device having at least one surface and comprising a coating on the at least one surface, the coating comprising: the taxane therapeutic agent in a first taxane solid form, wherein the first taxane solid form is dihydrate paclitaxel, and in a second taxane solid form, wherein the second taxane solid form is amorphous paclitaxel, wherein at least 10% of the taxane therapeutic agent is present in the first taxane solid form, wherein the coated implantable medical device is a radially expandable vascular stent or a balloon catheter.

### Claim 16 (depends on 15)

The coated implantable medical device of claim 15, wherein the coating is free of a polymer.

### Claim 17 (depends on 15)

The coated implantable medical device of claim 15, wherein the coating comprises at least two layers, wherein each layer comprises at least one of the first taxane solid form and the second taxane solid form.