# US 5,349,044 A · Polyamide monofilament suture manufactured from higher order polyamide

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- Number: US 5,349,044 A
- Document ID: US5349044A
- Status: Granted
- Kind: A
- Application number: 08/126,679
- Filed: 1993-09-24
- Granted: 1994-09-20
- Earliest claimed: 1992-01-30
- Assignees: United States Surgical Corporation
- Inventors: Cheng-Kung Liu; John C. Brewer
- Web page: https://patentgrep.com/patent/US5349044A

## CPC

- A61L 17/04: Non-resorbable materials
- 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 higher order polyamide monofilament suture exhibits improved properties such as greater resistance to creep, greater knot security and greater chemical stability in aqueous environments.

## Claims

### Claim 1

A polyamide monofilament suture manufactured from a fiber-forming polyamide homopolymer or copolymer possessing a substantial number of units selected from the group consisting of units of the structure in which n is at ##STR5## at least about 7 and units of the structure ##STR6## in which R.sup.1 is an aliphatic group of from about 4 to about 20 carbon atoms, a cycloaliphatic group of from about 6 to about 20 carbon atoms or an aromatic group of from about 6 to about 20 carbon atoms and R.sup.2 is an aliphatic, cycloaliphatic or aromatic group of from about 6 to about 20 carbon atoms, provided, R.sup.1 contains at least 6 carbon atoms when R.sup.2 is an aliphatic group of 6 carbon atoms or R.sup.2 contains at least 8 carbon atoms when R.sup.1 contains 4 carbon atoms, provided, that where the polyamide is a copolymer, any units other than the aforesaid units which may be present contain a carbonyl, the suture being manufactured from the polyamide by an extrusion process which comprises the steps of extruding the polyamide resin at an extrusion temperature of from about 180.degree. to about 290.degree. C. to provide a monofilament, stretching the solidified monofilament at a temperature of from about 40.degree. to about 98.degree. C. in liquid medium or at from about 50.degree. to about 185.degree. C. in gaseous medium at a stretch ratio of from about 3:1 to about 5:1 to provide a stretched monofilament and annealing the stretched monofilament at a temperature of from about 100.degree. to about 240.degree. C. to provide the finished suture, the annealing resulting in shrinkage of the stretched monofilament for a recovery to within about 80% to about 97% of the length of the monofilament prior to annealing, said monofilament having a decreased 0-5% energy compared to a cold-drawn monofilament of the same size and composition.

### Claim 2 (depends on 1)

The suture of claim 1 wherein the polyamide contains at least about 30 mole percent of the units.

### Claim 3 (depends on 1)

The suture of claim 1 wherein the polyamide contains at least about 50 mole percent of the units.

### Claim 4 (depends on 1)

The suture of claim 1 wherein the polyamide contains at least about 70 mole percent of the units.

### Claim 5 (depends on 1)

The suture of claim 1 wherein R.sup.1 is about C.sub.4 aliphatic and R.sup.2 is about C.sub.10 aliphatic.

### Claim 6 (depends on 1)

The suture of claim 1 wherein R.sup.1 is about C.sub.4 aliphatic and R.sup.2 is about C.sub.12 aliphatic.

### Claim 7 (depends on 1)

The suture of claim 1 wherein R.sup.1 is about C.sub.8 aliphatic and R.sup.2 is about C.sub.8 aliphatic.

### Claim 8 (depends on 7)

The suture of claim 7 wherein R.sup.1 is about C.sub.6 aliphatic and R.sup.2 is about C.sub.4-8 aliphatic.

### Claim 9 (depends on 1)

The suture of claim 1 wherein R.sup.1 is about C.sub.6 aliphatic and R.sup.2 is about C.sub.12 aliphatic.

### Claim 10 (depends on 1)

The suture of claim 1 containing up to about 1 percent by weight of material selected from the group consisting of dyes and pigments.

### Claim 11 (depends on 1)

The suture of claim 1 wherein the units containing a carbonyl are derived from at least one member selected from the group consisting of lactone, alpha-hydroxy carboxylic acid, oligomer of alpha-hydroxy carboxylic acid, aminocarboxylic acid and lactam.

### Claim 12 (depends on 1)

The suture of claim 1 exhibiting not more than about 6 percent creep in an aqueous medium under 1.8 g/den tension.

### Claim 13 (depends on 1)

The suture of claim 1 exhibiting at least about 85 percent wet strength retention for knot pull.

### Claim 14 (depends on 1)

The suture of claim 1 exhibiting at least about 95 percent wet strength retention for straight pull.

### Claim 15

A polyamide monofilament suture manufactured from nylon 12, the suture being manufactured by an extrusion process which comprises the steps of extruding the nylon 12 resin at an extrusion temperature of from about 180.degree. to about 290.degree. C. to provide a monofilament, stretching the solidified monofilament at a temperature of from about 40.degree. to about 98.degree. C. in liquid medium or at from about 50.degree. to about 185.degree. C. in gaseous medium at a stretch ratio of from about 3:1 to about 5:1 to provide a stretched monofilament and annealing the stretched monofilament at a temperature of from about 100.degree. to about 240.degree. C. to provide the finished suture, the annealing resulting in shrinkage of the stretched monofilament for a recovery to within about 80% to about 97% of the length of the monofilament prior to annealing, said monofilament having a decreased 0-5% energy compared to a cold-drawn nylon 12 monofilament of the same size.

### Claim 16 (depends on 15)

The suture of claim 15 exhibiting not more than about 6 percent creep in an aqueous medium under 1.8 g/den tension.

### Claim 17 (depends on 15)

The suture of claim 15 exhibiting at least about 85 percent wet strength retention for knot pull.

### Claim 18 (depends on 15)

The suture of claim 15 exhibiting at least about 95 percent wet strength retention for straight pull.
