# US 9,750,627 B2 · Treatment of diabetic patients with a stent and locally administered adjunctive therapy

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- Number: US 9,750,627 B2
- Document ID: US9750627B2
- Status: Granted
- Kind: B2
- Application number: 14/980,473
- Filed: 2015-12-28
- Published: 2016-06-30
- Granted: 2017-09-05
- Earliest claimed: 2012-03-30
- Assignees: Abbott Cardiovascular Systems Inc.
- Applicants: Abbott Cardiovascular Systems Inc.
- Inventors: Syed F. A. Hossainy
- Web page: https://patentgrep.com/patent/US9750627B2

## CPC

- A61F 2/958: Inflatable balloons for placing stents or stent-grafts
- 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)
- A61F 2/844: folded prior to deployment
- A61F 2/915: with bands having a meander structure, adjacent bands being connected to each other
- A61L 29/043: {Polysaccharides}
- A61L 29/085: {Macromolecular materials}
- A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)}
- A61L 31/042: {Polysaccharides}
- A61L 31/10: Macromolecular materials
- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61M 25/007: {Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked}
- 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})
- A61F 2250/0067: Means for introducing or releasing pharmaceutical products into the body
- A61L 2300/204: with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
- A61L 2300/41: Anti-inflammatory agents, e.g. NSAIDs
- A61L 2300/416: Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
- A61L 2300/606: Coatings
- A61L 2400/10: Materials for lubricating medical devices
- A61M 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes}
- 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)
- 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

Embodiments of the present invention include methods of treating, preventing, and/or ameliorating a vascular disease and/or disorder in a diabetic or pre-diabetic patient. The methods include implanting a stent in a vascular region in a diabetic or pre-diabetic patient, and prior to and/or during the implantation procedure, delivering a lubricant formulation to the vascular region. The stent may be a bare metal stent, or a drug eluting stent, such as a metal stent with a coating including a drug, such as everolimus or sirolimus.

## Claims

### Claim 1

A method of treating, preventing, or ameliorating a vascular disease, a vascular disorder, or both in a diabetic or pre-diabetic patient, the method comprising:
delivering a stent to, and deploying the stent at a vascular region of a patient; and
prior to, during, or both prior to and during the deployment of the stent, administering a lubricant formulation to the vascular region of the patient;
wherein the patient is identified as having a diabetic condition or a pre-diabetic condition;
wherein the patient is in need of treating, preventing, or ameliorating a vascular disease, a vascular disorder, or both;
wherein the lubricant formulation administration comprises delivery by a balloon, a dual balloon catheter, a balloon catheter, a guide catheter, a micro-catheter, or a combination thereof;
wherein the lubricant formulation comprises at least one substance selected from the group consisting of collagen, starches, the homopolymer of acrylic acid, and combinations thereof; and
wherein the lubricant formulation is a fluid that is free of drugs, wherein said drugs do not include said substances of the lubricant formulation.

### Claim 2 (depends on 1)

The method of claim 1, wherein the lubricant formulation administration comprises delivery through an array of holes in a catheter, the catheter being used to deliver the lubricant formulation and optionally used to deliver and deploy the stent.

### Claim 3 (depends on 1)

The method of claim 1, wherein the lubricant formulation administration comprises release from the middle section between the two balloons of a dual balloon catheter, and wherein the stent is also mounted on the balloon and is deployed simultaneously with the balloon inflation and lubricant formulation release.

### Claim 4 (depends on 1)

The method of claim 1, wherein the lubricant formulation administration comprises delivery from a catheter balloon, the stent being mounted on at least a portion of the length of the catheter balloon, and the lubricant formulation being disposed over the entire length, or substantially the entire length, of the balloon.

### Claim 5 (depends on 4)

The method of claim 4, wherein the lubricant formulation is also disposed over at least a portion of the mounted stent.

### Claim 6 (depends on 1)

The method of claim 1, wherein the lubricant formulation administration comprises delivery from a balloon used prior to dilatation of the vascular region and wherein the delivery of the stent comprises delivery by a stent delivery system which does not comprise the pre-dilatation balloon.

### Claim 7 (depends on 1)

The method of claim 1, wherein lubricant formulation administration comprises release from a catheter, the catheter being used to deliver the lubricant formulation and optionally used to deliver and deploy the stent.

### Claim 8 (depends on 7)

The method of claim 7, wherein the release of the lubricant formulation from the catheter occurs when the stent is ready to deploy but before the stent is actually deployed.

### Claim 9 (depends on 7)

The method of claim 7, wherein the release of the lubricant formulation from the catheter occurs when the stent is ready to deploy, during the deployment of the stent, or both when the stent is ready to deploy and during the deployment of the stent.

### Claim 10 (depends on 1)

The method of claim 1, wherein the lubricant formulation comprises collagen.

### Claim 11 (depends on 1)

The method of claim 1, wherein the lubricant formulation comprises at least one starch.

### Claim 12 (depends on 11)

The method of claim 11, wherein the lubricant formulation comprises the homopolymer of acrylic acid.

### Claim 13 (depends on 1)

The method of claim 1, the method further comprising the delivery of a drug coated balloon to the vascular region and expansion of the drug coated balloon to release the drug of the drug coated balloon at the vascular region.

### Claim 14 (depends on 13)

The method of claim 13, wherein the expansion of the drug coated balloon occurs prior to the administration of the lubricant formulation and prior to the deployment of the stent.

### Claim 15 (depends on 13)

The method of claim 13, wherein the drug of the drug coated balloon is an anti-inflammatory, an antiproliferative, a thiazolidinedione, or a combination thereof.

### Claim 16 (depends on 13)

The method of claim 13, wherein the drug of the drug coated balloon is rapamycin (sirolimus), Biolimus A9, myolimus, deforolimus, AP23572, tacrolimus, temsirolimus, pimecrolimus, novolimus, zotarolimus (ABT-578), 40-O-(2-hydroxy)ethyl-rapamycin (everolimus), 40-O-(3-hydroxypropyl)rapamycin, 40-O-[2-(2-hydroxy)ethoxy]ethyl-rapamycin, 40-O-tetrazolylrapamycin, 40-epi-(N1-tetrazolyl)-rapamycin, or any combination thereof.

### Claim 17 (depends on 1)

The method of claim 1, wherein the stent is a drug eluting stent.

### Claim 18 (depends on 17)

The method of claim 17, wherein the drug of the drug eluting stent is rapamycin (sirolimus), Biolimus A9, myolimus, deforolimus, AP23572, tacrolimus, temsirolimus, pimecrolimus, novolimus, zotarolimus (ABT-578), 40-O-(2-hydroxy)ethyl-rapamycin (everolimus), 40-O-(3-hydroxypropyl)rapamycin, 40-O-[2-(2-hydroxy)ethoxy]ethyl-rapamycin, 40-O-tetrazolylrapamycin, 40-epi-(N1-tetrazolyl)-rapamycin, or any combination thereof.