Patent Application
20070227916
1. Technical Field
The present disclosure relates generally to packaging for storing and dispensing surgical devices, and more particularly, to a package for storing and dispensing steel sutures whereby the steel sutures are retained within a container.
2. Background of Related Art
A number of packages and packaging methods have been proposed over the years for packaging and delivering sutures to a surgeon in a sterile condition. However, packaging of steel surgical sutures has posed particular problems because of their size, stiffness and manner of their packaging. Stainless steel sutures require that they be secured properly to prevent displacement within the packaging, bending or kinks within the steel filament, as well as being simply and quickly removable from the packaging for use by the surgeon.
Monofilament stainless steel sutures have extremely high tensile strength relative to the diameter of the material. When implanted into tissue, stainless steel sutures will not split spontaneously and are capable of being twisted to very high tightness approaching the maximum tensile strength of the material. Stainless steel sutures have been packaged in long cardboard envelopes contained within a sterile sealable breather pouch. A continuing need exists for improved suture packaging and methods for containing steel sutures.
Therefore, it is desirable to package stainless steel sutures in a manner where they are sufficiently separated for ready access to the user when they are needed and to prevent kinks from forming in the filament. Moreover, the suture packages must be capable of receiving and holding sutures of various sizes while generally not affecting the quality, shape or strength of the suture in any way.
Accordingly, a suture package in accordance with the present disclosure includes an outer envelope and an inner retainer with four C-shaped slits equally spaced apart to releasably retain a hollow tube container therein, the container configured and dimensioned to retain steel sutures therein.
In another embodiment, the method of assembling the suture package for storing and dispensing steel sutures therein in accordance with the present disclosure includes providing a hollow tube container with one end cap, placing steel sutures within the container and capping the open end to enclose the sutures therein, providing an inner retainer with four C-shaped slits equally spaced apart whereas the container is placed through the slits in a manner for releasably securing the container within the inner retainer and providing a sterilized outer envelope to enclose the inner retainer within.
Although specific embodiments of the present disclosure will now be described with reference to the drawings, it should be understood that such embodiments are by way of example only and merely illustrative of but a small number of the many possible specific embodiments which can represent applications of the principles of the present disclosure. Various changes and modifications obvious to one skilled in the art to which the present disclosure pertains are deemed to be within the spirit, scope and contemplation of the present disclosure as further defined in the appended claims.
In general, the present disclosure provides a suture package and packaging method which ensures rapid access to sutures, economically and efficiently contained within a hollow tube container to ensure containment, easier handling and storing of the steel sutures with reduced risk of compromising the sterility of the steel sutures beyond its sterilized field. Each suture is readily disposed in an advantageous, readily accessible position in the package, to be grasped with minimum possibility of pulling unwanted sutures from the package, or the need to fumble through a plurality of steel sutures to ensure that a single suture is obtained. Moreover, the manner in which the steel sutures are supplied in accordance with the present disclosure ensures that the sutures provided are in sterile condition, and without kinks or other deformities which might adversely affect their strength.
Once the sutures are assembled in the package of the present invention, the sterile package is overwrapped with a sterile barrier such as a Tyvek® commercially made by DuPont (pouch, which is impervious to germs, and which will have sufficient strength to be handled and stored without loss of sterility of the interior pack, and one which can be easily opened during transfer to the sterile field of an operation.
Referring now to
The outer envelope 50 includes a pair of sheets 52 and 54 which form a sterility barrier. Sheet 52 may be formed of a suitable sterile barrier packaging material such as the commercially manufactured Tyvek®. Sheet 54 may be formed of a transparent or translucent material such as for example a clear polyethylene sheet. The two sheets are adhered together on three sides by a peripheral line of peelable adhesive 55. To make the fourth side of the seal, the adhesive 55 spans the package 10 in a manner that creates two flaps 56, 58 by which the two sheets of the outer envelope 50 can be readily pulled apart.
Referring to
Referring to
To assemble the package, one end-cap 204 is placed on one end of hollow tube 202. Steel sutures 308 are then placed into the other, open end of hollow tube 202. Once sutures 308 are all within hollow tube 202, the second end-cap 206 is placed on the open end of hollow tube 202 to enclose sutures 308 within storage container 200. Once end caps 204, 206 are placed onto container 200 retaining the sutures 308, the steel sutures 308 are sterilized using methods generally known by those skilled in the art. For example, some sterilization techniques include gamma irradiation, electron beam (E beam), treatment with ethylene oxide, or other chemical or physical treatments providing sterilization.
Container 200 is releasably secured within inner retainer 100 by the four slits 102, 104, 106, 108. Container 200 enters first slit 102 from the front side 100a of inner retainer 100 and passes underneath label 110 before entering the second slit 104 from the rear side of inner retainer 100. From there, container 200 proceeds along the front side 100a of inner retainer 100 before entering the third slit 106 and passing underneath label 112 before entering the fourth slit 108 from the rear side of inner retainer 100 and ending on the top side 100a of inner retainer 100.
The inner retainer 100, with container 200 releasably secured therein, is sealed between the two sheets of the outer envelope 50. The outer envelope 50 can be any conventional envelope for medical devices manufactured from any suitable material known to those skilled in the art. In one embodiment, outer envelope 50 is formed by heat sealing two panels of aluminum foil coated on the interior surfaces thereof with a heat sealable polymeric composition. The envelope is bonded around the periphery of the inner sealable pouch as illustrated in
In another embodiment, outer envelope 50 may be formed from a hydrophobic material. The term “hydrophobic”, as described herein, refers to materials that are not normally water soluble and absorb relatively low amounts of water, i.e., less than about 10% by weight. Some examples of these materials include, but are not limited to, polymers, copolymers, homopolymers, and block copolymers formed from monomers such as ε-caprolactone, glycolide, 1-lactide, d, 1-lactide, d-lactide, meso-lactide, trimethylene carbonate, 4,4-dimethyl-1,3-dioxan-2-one, p-dioxanone, dioxepanone, δ-valerolactone, β-butyrolactone, ε-decalactone, 2,5-diketomorpholine, pivalolactone, α,α-diethylpropiolactone, 6,8-dioxabicyclooctan-7-one, ethylene carbonate, ethylene oxalate, 3-methyl-1,4-dioxane-2,5-dione, 3,3-dimethyl-1,4-dioxane-2,5-dione, and other subtituted glycolides, and substituted lactides. Some additionally useful hydrophobic materials include polyolefins (i.e. Tyvek.®) and polysiloxanes.
In another embodiment, outer envelope 50 may be formed from a hydrophilic material. The term “hydrophilic”, as described herein, refers to materials that are normally water soluble and absorb relatively high amounts of water. Some examples of these materials include, but are not limited to, polyalkylene glycols, such as polyethylene glycol, polyacrylates such as polymers of methacrylates and 2-hydroxyethyl methylacrylate, aminoalkyl acrylates, such as N,N-dimethylacrylamide, polyvinylalcohols, polyvinylpyrrolidones, polyoxyethylenes, polyacrylamides, poly(2-hydroxy-ethylmethacrylate), polymethacrylamide, dextran, alginic acid, sodium alginate, polysaccharides, gelatine and copolymers of two or more of the monomers from which the above polymers are derived and polyoxyethylene/polyoxypropylene block copolymers.
In still another embodiment, outer envelope 50 can be made of a combination of hydrophobic and hydrophilic materials. An example of an outer envelope with a combination of hydrophobic and hydrophilic materials can include a polyolefin sheet (i.e. Tyvek.®) and a polyethylene sheet adhered together with a release agent.
When the suture is to be used, it is easily removed from the package by pulling off an end cap and grasping one end of the suture and pulling the suture upwardly. The removal of the suture is greatly facilitated by the hollow tube opening. For example, the surgeon or surgical nurse can invert the tube slightly to displace a surgical suture from the hollow tube and pull the suture out of the package without a mass of sutures falling out into the non-sterile field. Thus, the possibility of tangling the sutures or pulling more than one suture out of the package is avoided. The process of getting the suture to the surgeon, with the suture ready for application to the patient without having to re-sterilize or having to obtain a new suture due to a deformity in the suture, is vastly simplified and corrected, compared to prior approaches.
Those skilled in the art will readily appreciate a variety of embodiments once acquainted with the present disclosure, all of which are intended to be included within the scope of the following claims.
