# US 2019/0167859 A1 · Implantable medical products, a process for the preparation thereof, and use thereof

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- Number: US 2019/0167859 A1
- Document ID: US20190167859A1
- Status: Published application
- Kind: A1
- Application number: 16/074,134
- Filed: 2017-01-31
- Published: 2019-06-06
- Earliest claimed: 2016-02-01
- Assignees: Jörg Michael Schierholz
- Inventors: Jörg Michael SCHIERHOLZ
- Web page: https://patentgrep.com/patent/US20190167859A1

## CPC

- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61K 31/4174: Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
- A61K 31/444: containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone
- A61K 31/496: Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
- A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
- A61L 27/34: Macromolecular materials
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61L 29/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
- A61L 29/10: Inorganic materials
- A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)}
- A61L 31/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)}
- A61L 31/10: Macromolecular materials
- A61L 33/0041: {characterised by the choice of an antithrombatic agent other than heparin (heparinoïd A61L33/08; polypeptides A61L33/12)}
- A61L 33/04: Use of organic materials, e.g. acetylsalicylic acid
- A61L 2300/216: with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
- A61L 2300/404: Biocides, antimicrobial agents, antiseptic agents
- A61L 2300/406: Antibiotics
- 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 2300/42: Anti-thrombotic agents, anticoagulants, anti-platelet agents
- A61L 2300/424: Anti-adhesion agents
- A61L 2420/02: Methods for coating medical devices
- 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)

## Abstract

Implantable medical product, comprising a basic body and an imidazole derivative in the form of its free base; wherein said basic body has on its polymeric surface a layer containing the imidazole derivative as an active ingredient, which displays an antithrombogenic, antiproliferative, anti-inflammatory or antiadhesive effect, or a combination thereof.

## Claims

### Claim 1

An implantable medical product, comprising a basic body having a polymer surface and an imidazole derivative in the form of its free base;
wherein said basic body has on its polymeric surface a layer comprising the imidazole derivative as an active ingredient, which displays an antithrombogenic, antiproliferative, anti-inflammatory or antiadhesive effect, or a combination thereof.

### Claim 2 (depends on 1)

The implantable medical product according to claim 1, wherein said imidazole derivative forms said layer comprising the imidazole derivative, or is in a molecular dispersed form in a support material.

### Claim 3 (depends on 1)

The implantable medical product according to claim 1, wherein said imidazole derivative is clotrimazole or miconazole.

### Claim 4 (depends on 1)

The implantable medical product according to claim 1, wherein said basic body comprises a plastic material, a ceramic, a metal, a metal alloy, a composite material, or combinations thereof.

### Claim 5 (depends on 1)

The implantable medical product according to claim 1, wherein said basic body comprises a polyurethane, a silicone, a polyamide, a polyethylene terephthalate, a polytetrafluoroethylene, a polyethylene, a biodegradable polymer, a chromium-nickel steel, a cobalt alloy, a titanium alloy, a hydroxyapatite derivative, or combinations thereof.

### Claim 6 (depends on 1)

The implantable medical product according to claim 1, wherein said layer comprising the imidazole derivative has a thickness of up to 5 μm.

### Claim 7 (depends on 1)

The implantable medical product according to claim 1, further comprising antibiotics antiseptics, corticosteroids, or combinations thereof.

### Claim 8 (depends on 1)

The implantable medical product according to claim 1, wherein the wetting angle of the surface as measured as a static water contact angle using a Kruess goniometer is more than 80°.

### Claim 9 (depends on 1)

The implantable medical product according to claim 1, wherein its keeping quality when stored under standard conditions is at least 6 months.

### Claim 10 (depends on 1)

The implantable medical product according to claim 1, wherein said medical product is a catheter.

### Claim 11 (depends on 1)

The implantable medical product according to claim 1, wherein said medical product is selected from the group consisting of stents, orthopedic, neurological, cardiological or ophthalmological implants, devices for treating parodontose, such as local drug carriers for periodontal pockets, intubators, intraocular lenses, medicament carriers for the topical subgingival application of antimicrobial substances, tracheostoma cannulas, pleura catheters, pleural drainages, pacemaker electrodes, cochlear implant electrodes, silicone shunts, silicone catheters, glaucoma drain devices, polyurethane catheters.

### Claim 12

A process for preparing an implantable medical product, comprising the steps of
a) providing a medical product basic body;
b) contacting said medical product basic body with an imidazole derivative;
c) rinsing, spraying or laminating the medical product;
further optionally comprising the steps of
d) drying the medical product;
e) sterilizing the medical product using ethylene oxide and/or by means of gamma radiation.

### Claim 13 (depends on 12)

The process for preparing an implantable medical product according to claim 12, further comprising the incorporation of a further antimicrobial substance into the basic body.

### Claim 14

An implantable medical product having an antithrombogenic, antiproliferative, antiadhesive and anti-inflammatory effect, comprising a basic body and an imidazole derivative in the form of its free base, wherein said basic body has on its polymeric surface a layer containing the imidazole derivative as an active ingredient.

### Claim 15

(canceled)

### Claim 16 (depends on 6)

The implantable medical product of claim 6, wherein said layer has a thickness of up to 2 μm.

### Claim 17 (depends on 6)

The implantable medical product of claim 6, wherein said layer has a thickness of up to 100 nm.

### Claim 18 (depends on 7)

The implantable medical product according to claim 7, wherein the antibiotic is fusidic acid or rifampicin or wherein the antiseptic is octenidine or wherein the corticosteroid is dexamethasone.

### Claim 19 (depends on 8)

The implantable medical product according to claim 8 wherein the static water contact angle is 90°-110°.

### Claim 20 (depends on 9)

The implantable medical product of claim 9, wherein its keeping quality is at least 12 months or at least 24 months.

### Claim 21 (depends on 10)

The implantable medical product of claim 10, wherein the catheter is an intravasal catheter.