# US 5,341,922 A · Peelable foil suture packaging

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- Number: US 5,341,922 A
- Document ID: US5341922A
- Status: Granted
- Kind: A
- Application number: 08/021,814
- Filed: 1993-02-24
- Granted: 1994-08-30
- Earliest claimed: 1993-02-24
- Assignees: Ethicon, Inc.
- Inventors: Robert Cerwin; Cheryl Trew; Robert J. Gibbs
- Web page: https://patentgrep.com/patent/US5341922A

## CPC

- A61B 17/06133: {of parallelepipedal shape, e.g. made of rectangular or slightly oval panels}
- A61B 90/94: coded with symbols, e.g. text
- A61B 17/06166: {Sutures (suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M)}
- A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive}
- A61B 2050/0065: {Peelable cover}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A peelable foil packaging system for absorbable or pre-moistened nylon sutures which may be used to transfer the sutures into a sterile field. In a preferred embodiment, the foil package comprises two foil sections each with a polymer inner coating. The sections are sealed together enclosing a suture holding mechanism which presents a needle with attached suture for arming a needle holder.

## Claims

### Claim 1

A suture package comprising
a first laminate comprising a first foil section laminated on a first side with a first polymer coating to form a material substantially impervious to moisture;
a second laminate comprising a second foil section laminated on a first side with a second polymer coating to form a material substantially impervious to moisture;
wherein said first laminate and said second laminate are sealed together to form a substantially moisture impervious seal and enclose a suture between the first laminate and the second laminate and within the seal;
wherein the first section and the second section each comprised a flap for grasping the package to peel said first section and said second section from each other;
wherein said package may be opened to enable transferring of the suture to a desired area;
wherein the first polymer coating and second polymer coating are heat-sealable polymers;
wherein said first laminate and said second laminate are heat sealed together; and
wherein the second polymer coating is peelable from the second foil section when the second polymer coating is heat sealed with the first polymer coating.

### Claim 2 (depends on 1)

The suture package of claim 1 wherein the foil comprises aluminum.

### Claim 3 (depends on 1)

The suture package of claim 1 wherein the first polymer coating and second polymer coating each comprise polypropylene.

### Claim 4 (depends on 1)

The suture package of claim 1 wherein the first polymer coating comprises polyethylene.

### Claim 5 (depends on 1)

The suture package of claim 1 wherein the first polymer coating comprises a copolymer of polyethylene and vinyl acetate.

### Claim 6 (depends on 1)

The suture package of claim 1 wherein said package has rounded corners.

### Claim 7 (depends on 1)

The suture package of claim 1 wherein the suture is an absorbable suture.

### Claim 8 (depends on 1)

The suture package of claim 1 wherein the suture comprises a pre-moistened hydrophilic nylon material.

### Claim 9

A suture package comprising
a first laminate comprising a first foil section laminated on a first side with a first polymer coating to form a material substantially impervious to moisture;
a second laminate comprising a second foil section laminated on a first side with a second polymer coating to form a material substantially impervious to moisture;
wherein said first laminate and said second laminate are sealed together to form a substantially moisture impervious seal and enclose a suture between the first laminate and the second laminate and within the seal;
wherein the first section and the second section each comprised a flap for grasping the package to peel said first section and said second section from each other;
wherein said package may be peeled opened to enable transferring of the suture to a desired area;
wherein said first polymer coating comprises an extrusion coated polymer; and
wherein said second polymer coating comprises a solvent based coated polymer.

### Claim 10 (depends on 9)

The suture package of claim 9 wherein the solvent based coated polymer comprises a dispersion coated polymer.

### Claim 11 (depends on 9)

The suture package of claim 9 wherein the seal has a seal strength of between 0.6 and 2 pounds per inch of seal width.

### Claim 12

A suture package comprising
a first laminate comprising a first foil section laminated on a first side with a first polymer coating to form a material substantially impervious to moisture;
a second laminate comprising a second foil section laminated on a first side with a second polymer coating to form a material substantially impervious to moisture;
wherein said first laminate and said second laminate are sealed together to form a substantially moisture impervious seal and enclose a suture between the first laminate and the second laminate and within the seal;
wherein the first section and the second section each comprised a flap for grasping the package to peel said first section and said second section from each other;
wherein said package may be opened to enable transferring of the suture to a desired area;
wherein the enclosed suture is attached to a suture holding mechanism; and wherein the suture holding mechanism comprises a bottom section having a plane, and means disposed on one side of said bottom section for holding the suture and displaying the needle on said side, a portion of said bottom section underlying said needle being deflectable out of the plane of said bottom section.

### Claim 13 (depends on 12)

The suture package of claim 12 wherein the suture holding mechanism further comprises a protective sleeve member enclosing said suture holding mechanism, said sleeve having a top, bottom and two longitudinal sides connecting said top and bottom, said bottom having a deflectable portion underlying the deflectable portion of said suture holding mechanism.

### Claim 14 (depends on 13)

The suture package of claim 13 wherein the protective sleeve member has a cut out portion on the top of said protective sleeve for exposing said needle on said suture holding mechanism.

### Claim 15 (depends on 13)

The suture package of claim 13 wherein the deflectable portion on the protective sleeve member is larger than the deflectable portion on said suture holding mechanism.

### Claim 16

A suture package comprising
a first laminate comprising a first foil section laminated on a first side with a first polymer coating to form a material substantially impervious to moisture;
a second laminate comprising a second foil section laminated on a first side with a second polymer coating to form a material substantially impervious to moisture;
wherein said first laminate and said second laminate are sealed together to form a substantially moisture impervious seal and enclose a suture between the first laminate and the second laminate and within the seal;
wherein the first section and the second section each comprised a flap for grasping the package to peel said first section and said second section from each other;
wherein said package may be opened to enable transferring of the suture to a desired area
wherein the stiffness of each of the first foil laminate and the second foil laminate is not greater than 0.017 inch pounds.

### Claim 17 (depends on 16)

The suture package of claim 16 wherein at least one of said first foil section and said second foil section have an outer layer of an adhesive material adhering an outer coating to said at least one of said first foil section and said second foil section.

### Claim 18 (depends on 17)

The suture package of claim 17 wherein the adhesive material comprises a urethane based material.

### Claim 19 (depends on 17)

The suture package of claim 17 wherein the adhesive material comprises a hot melt adhesive.

### Claim 20 (depends on 17)

The suture package of claim 17 wherein the outer coating comprises polypropylene.

### Claim 21 (depends on 17)

The suture package of claim 17 wherein the outer coating comprises polyethylene.

### Claim 22 (depends on 21)

The suture package of claim 21 wherein the outer coating further comprises polyester and nylon.

### Claim 23 (depends on 17)

The suture package of claim 17 wherein the outer coating is from 0.25 mil to 1 mil thick.

### Claim 24 (depends on 16)

The suture package of claim 16 wherein the thickness of the foil sections is between 0.7 and 2.0 mils.

### Claim 25 (depends on 16)

The suture package of claim 16 wherein the thickness of the foil sections is between 1 and 1.5 mil.

### Claim 26

A suture arming system comprising
a suture package sufficiently moisture impervious for storage of moisture sensitive absorbable sutures, and
a sterile suture holding mechanism;
wherein said suture package comprises:
a first laminate comprising a first foil section laminated on a first side with a first polymer coating to form a material substantially impervious to moisture,
a second laminate comprising a second foil section laminated on a first side with a second polymer coating to form a material substantially impervious to moisture,
wherein said first laminate and said second laminate are sealed together to form a substantially moisture impervious seal and enclose said suture holding mechanism between the first laminate and the second laminate and within the seal,
wherein the first section and second section each comprise a flap for grasping the package to peel said first section and said second section from each other;
wherein said package is peelable to enable a non sterile user to peel said package open so that said sterile suture holding mechanism can be transferred by the non sterile user from a non sterile area to a sterile area;
wherein the sterile suture holding mechanism includes a displayed suture needle with an attached suture, said suture holding mechanism capable of being separated from said package when transferred to the sterile field and, and suture needle being immediately accessible to a sterile user for arming a needle holder when said suture holding mechanism is separated from the suture package into the sterile field.

### Claim 27 (depends on 26)

The suture arming mechanism of claim 26 wherein said suture holding mechanism comprises a bottom section having a plane and means disposed on one side of bottom section for holding the suture and displaying the needle on said side, a portion of the bottom underlying said needle being deflectable out of the plane of said bottom section.

### Claim 28 (depends on 27)

The suture system of claim 27 wherein said suture holding mechanism further comprises
a protective sleeve member enclosing said suture holding mechanism, said sleeve having a top, bottom, and two longitudinal sides connecting said tip and bottom, said bottom having a deflectable portion underlying the deflectable portion of said suture holding mechanism.

### Claim 29 (depends on 28)

The suture system of claim 28 wherein said protective sleeve is labeled to identify the suture contained in the suture holding mechanism.

### Claim 30 (depends on 28)

The suture system of claim 28 wherein the protective sleeve member has a cut out portion on the top of said protective sleeve for exposing said needle on said suture holding mechanism.

### Claim 31 (depends on 28)

The suture system of claim 28 wherein the deflectable portion on the protective sleeve member is larger than the deflectable portion on the suture holding mechanism.

### Claim 32 (depends on 26)

The suture system of claim 26 wherein said seal has a seal strength of from 0.6 to 2.0 pounds per inch of seal width.

### Claim 33 (depends on 16)

The suture package of claim 16 wherein the seal has a seal strength of between 0.6 to 2.0 pounds per inch of seal width.
