# US 10,500,388 B2 · Medical devices and methods of making medical devices

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- Number: US 10,500,388 B2
- Document ID: US10500388B2
- Status: Granted
- Kind: B2
- Application number: 11/690,567
- Filed: 2007-03-23
- Published: 2007-09-27
- Granted: 2019-12-10
- Earliest claimed: 2005-09-22
- Assignees: The University of Nottingham
- Applicants: Roger Bayston
- Inventors: Roger Bayston
- Web page: https://patentgrep.com/patent/US10500388B2

## CPC

- A61M 39/0247: {Transcutaneous or percutaneous access sites to the inside of the body}
- A61B 17/60: for external osteosynthesis, e.g. distractors, contractors
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- 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)}
- A61L 2300/404: Biocides, antimicrobial agents, antiseptic agents
- A61L 2300/406: Antibiotics
- A61L 2300/45: Mixtures of two or more drugs, e.g. synergistic mixtures
- A61M 2039/025: {through bones or teeth, e.g. through the skull}
- A61M 2039/0285: {with sterilisation means, e.g. antibacterial coatings, disinfecting pads, UV radiation LEDs or heating means in the port}
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)

## Abstract

A medical device material impregnated with a combination of antimicrobial agents, the combination of antimicrobial agents comprising a first antimicrobial agent, the first antimicrobial agent being triclosan and at least a second antimicrobial agent, wherein the combination of antimicrobial agents provides the device material with antimicrobial activity and inhibition of resistant microbial mutations for of the order of, or greater than, 80 days.

## Claims

### Claim 1

A medical device material consisting of a polymeric material impregnated with a first antimicrobial agent being triclosan, a second antimicrobial agent being rifampin, and a third antimicrobial agent being clindamycin, wherein the concentration of triclosan in the polymeric material is between 0.1% and 3% w/w in comparison to the weight of the polymeric material, the concentration of the second antimicrobial agent in the polymeric material is 0.05 mg/g in comparison to the weight of the polymeric material, the concentration of the third antimicrobial agent in the polymeric material is 0.16 mg/g in comparison to the weight of the polymeric material and wherein the medical device material provides antimicrobial activity and inhibition of resistant microbial mutations for 80 days or more for both gram-positive and gram-negative bacteria.

### Claim 2 (depends on 1)

The medical device material of claim 1, wherein the gram-negative bacteria includes Escherichia coli and wherein the gram-positive bacteria includes Staphylococcus aureus.

### Claim 3 (depends on 1)

The medical device material of claim 1, wherein the polymeric material is selected from the group consisting of silicone elastomer, a polyalkene, polyethylene terephthalate, polyvinyl chloride, polytetrafluoroethylene (PTFE), silicone polyurethane copolymer and polyurethane latex.

### Claim 4 (depends on 1)

The medical device material of claim 1, wherein the medical device material provides antimicrobial activity and inhibition of resistant microbial mutations for 90 days or more.

### Claim 5 (depends on 1)

The medical device material of claim 1, wherein the medical device material provides antimicrobial activity and inhibition of resistant microbial mutations for 100 days or more.

### Claim 6 (depends on 1)

The medical device material of claim 1, wherein the medical device material provides antimicrobial activity and inhibition of resistant microbial mutations for 120 days or more.

### Claim 7 (depends on 1)

The medical device material of claim 1, wherein the medical device material provides antimicrobial activity and inhibition of resistant microbial mutations for 140 days or more.

### Claim 8 (depends on 1)

The medical device material of claim 1, wherein the medical device material provides antimicrobial activity and inhibition of resistant microbial mutations for 160 days or more.

### Claim 9 (depends on 1)

The medical device material of claim 1, wherein the medical device material provides antimicrobial activity and inhibition of resistant microbial mutations for 190 days or more.

### Claim 10

A medical device comprising a medical device material consisting of a polymeric material impregnated with a first antimicrobial agent being triclosan, a second antimicrobial agent being rifampin, and a third antimicrobial agent being clindamycin, wherein the concentration of triclosan in the polymeric material is between 0.1% and 3% w/w in comparison to the weight of the polymeric material, the concentration of the second antimicrobial agent in the polymeric material is 0.05 mg/g in comparison to the weight of the polymeric material, the concentration of the third antimicrobial agent in the polymeric material is 0.16 mg/g in comparison to the weight of the polymeric material and wherein the medical device material provides antimicrobial activity and inhibition of resistant microbial mutations for 80 days or more for both gram-positive and gram-negative bacteria.

### Claim 11 (depends on 10)

The medical device of claim 10, wherein the gram-negative bacteria includes Escherichia coli, and wherein the gram-positive bacteria includes Staphylococcus aureus.

### Claim 12 (depends on 10)

The medical device of claim 10, wherein the medical device provides antimicrobial activity and inhibition of resistant microbial mutations for 90 days or more.

### Claim 13 (depends on 10)

The medical device of claim 10, wherein the medical device provides antimicrobial activity and inhibition of resistant microbial mutations for 100 days or more.

### Claim 14 (depends on 10)

The medical device of claim 10, wherein the medical device provides antimicrobial activity and inhibition of resistant microbial mutations for 120 days or more.

### Claim 15 (depends on 10)

The medical device of claim 10, wherein the medical device provides antimicrobial activity and inhibition of resistant microbial mutations for 140 days or more.

### Claim 16 (depends on 10)

The medical device of claim 10, wherein the medical device provides antimicrobial activity and inhibition of resistant microbial mutations for 160 days or more.

### Claim 17 (depends on 10)

The medical device of claim 10, wherein the medical device provides antimicrobial activity and inhibition of resistant microbial mutations for 190 days or more.

### Claim 18 (depends on 10)

The medical device of claim 10, wherein the polymeric material is selected from the group consisting of silicone elastomer, a polyalkene, polyethylene terephthalate, polyvinyl chloride, polytetrafluoroethylene (PTFE), silicone polyurethane copolymer and polyurethane latex.

### Claim 19 (depends on 10)

The medical device of claim 10, wherein the medical device is selected from the group consisting of: an external ventricular drainage device, an ommaya reservoir, an intraspinal pump, a central venous catheter, an ascites shunt, a pacemaker, a continuous ambulatory peritoneal catheter, a voice prosthesis, a vascular graft, a urinary catheter, an intraocular lens and a wound guard.

### Claim 20 (depends on 10)

The medical device of claim 10, which has a transdermal portion.

### Claim 21 (depends on 19)

The medical device of claim 19, wherein the device comprises a urinary catheter.

### Claim 22 (depends on 10)

The medical device of claim 10, wherein the medical device is a continuous ambulatory peritoneal dialysis catheter.