CA1215658A - Closable container for receiving and disposing of surgical sharps - Google Patents

Abstract

CLOSABLE CONTAINER FOR RECEIVING AND DISPOSING OF SURGICAL SHARPS

ABSTRACT OF THE DISCLOSURE
A closable container is provided for receiving and disposing of surgical sharps following their use in any surgical procedure. Surgical sharps include suture needles, blades, pins, and hypodermic needles, all of which may easily cut or puncture tissue, and all of which may become contaminated after use due to contact with contaminated tissue. The container is formed using a continuous vacuum-forming process, generally on form, fill and seal packaging machines that may be somewhat modified, from continuous rolls of sheet thermoplastic material, so that the container comprises pair of trays with a living hinge between them. An upstanding lip around one of the trays is accommodated in the other tray when the container is closed. A magnetic material is adhered to the outside flat surface of at least one of the trays so as not to come into contact with the instruments that may touch the tray, such as needle holders used during suturing. A foam layer may be placed in one of the trays; and both of the trays and foam when installed may or may not be marked with indicia for easy counting depending on the surgeon's or nurses individual preference. A suture organizer comprising a convoluted layered structure, may also be provided. The container may then be reprocessed through the same machine to seal it inside a package so that it can be provided in a sterile condition for opening in the operating theater. The container, though deformable, is sufficiently semi-rigid and tough so as to prevent sharps from piercing through the container walls to the outside; and together with its lip and hinge, provides a safe receptacle for the disposal of surgical sharps.

Description

FIELD OF THE INVENTION 5~5~
This invention relates to containers for receiving and disposing of surgical sharps following their use in any surgical procedure. In particular, this invention provides a semirigid container that may be used for receiving and disposing of surgical sharps, wherein a count of` the surgical sharps used in a procedure is accurately kept, and whereby a variety of sharps such as suture needles, blades, pins, or hypodermic needles may be collected and disposed of in the same container.
BACKGROUND OF THE INVENTION:
. _ _ In any surgical procedure, the surgeon may use a variety of various sharp instruments such as suture needles, scalpel blades, pins, or even hypodermic needles. It is, of course, important that such surgical sharps be disposed of safely, without risk of contamination or risk of damage to persons handling the containers in which they are disposed of; and moreover, there is the paramount requirement that all surgical sharps that have been used must be counted, so as to eliminate the likelihood of loss of the sharps in the patients body.
Accordingly, a number of different proposals have been made, and equipment provided to surgeons to attempt to serve the purposes noted immediately above. Such prior art devices all have one or more drawbacks, including expense of manufacture, and particularly including risk of exposure and contact by certain non-disposable instruments that are used by the surgeons -- such as suture holders -- to magnetic dust particles, and the risk of 27 contamination of an open wound by such magnetic dust particles.

By manufacturing the container of the present invention using a continuous vacuum forming process on standard form, fill and seal packaging equipment, significant cost reductions over ~56S~3 the presently available surgical sharps-disposing containers are realized. What is particularly meant by "form, fill and seal packaging equipment" is equipment of the sort that may vacuum form a tray, fill it with a product, and then apply a seal over the lips of the tray (or otherwise) at various stations along the length of the same machine.

At the same time, it is desirable that an inexpensive disposable container be provided in a sterile condition for use by the scrub nurse during the surgical procedure at the surgical site. This may be accomplished by sealing the container into an outer package for sterilization according to the usual sterilization procedures for prepackaged surgical products.
It may also be desirable that a foam strip be placed in a container for receiving certain kinds of suture needles; for example, certain non-magnetizable suture needles. Moreover, some nurses have a personal preference for using a grid-marked foam block to hold the needles for counting. To accommodate such professional practices and preferences, the present invention may provide for a numbered or indicia-marked foam block which is adhered to one tray of the container. For the most part, however, surgical sharps are magnetizable, and it is that characteristic that permits them to be aligned against a counting grid for easy counting or recounting purposes.
It is a feature of the present invention that the closable container is, in its normal operating position, open;
27 and that it is usually supplied in an open fashion, in a sterilized condition. It is also advantageous, and in the mode of practice of many scrub nurses, that the surgical sharps be carefully organized prior to their use during the ensuing surgical procedure. To this end, the container may then be ~56S8 supplied with an "organizer" in such a manner that it may be easily attached thereto, so that the scrub nurse may see what unused sharps are available, and so as to enable her to easily tally her count of unused and used sharps. The organizer simply comprises a convoluted structure having a plurality of longitudinal pockets one above another, where each pocket is exposed for easy access.
The prior art includes STAYER US. Patent 3,197,915, issued August 3, 1965, which is directed to a magnetic box for various items, particularly fishhooks for fly fishing. The patent is of interest, but it requires that the box is made of ferrous sheet metal which may be tinned to prevent rust, and that it has a loaded plastic, permanently magnetized material placed in it, against which the hooks may be secured while leaving the simulated wings or feathers clear of any interference with and other structure.
ELDRIDGE, US. Patent 3,727,658 issued April 17, 1973, provides a receiver for surgical implements, which must be magnetizable, and which comprises a plurality of magnets.
However, the receiver is not a container giving rise to certain dangers of handling.
SANDER, US. Patent 4,013,109 issued March 22, 1977, provides a disposable container for surgical instruments, which is a rigid, non-deformable case that may be injection molded frown plastic, having a ribbed or otherwise non-planar magnetic means secured on the inside of the case, whereby there is a great risk 27 of contamination of the surgeon's needle holder or other instruments. The Sander structure is expensive to manufacture, expensive to assemble, and expensive to purchase in the market.
HORVATII ET AL, US. Patent 4,105,115 issued August 8, 1978, provides a suture and needle holder that also has an organizer associated with it. Louvre, the structure is a complicated and expensive one, and is not readily adapted to being positioned on a surgical drape at a convenient place as may be determined at the moment by the surgeon or scrub nurse.
BARRETT, US. Patent 4,167,230 issued September 11, 1979, teaches yet another disposable receiver that has a single tray with a cover hinged to it by a separate tape, and having a foamed plastic material with magnetic strips beneath it secured in the bottom of the single tray. An alternative embodiment provides a ribbed foamed plastic material without the utilization of magnetic material; but there is no embodiment that has both a pier cable foam and a magnetic material.
THRUM, US. Patent 4,243,140 issued January 6, 1981, on the other hand, teaches a surgical needle and sharps holding container 'chat has two trays more or less joined with a living hinge, but having a plurality of slotted strips in which suture needles may be held, on one tray; and having a further slotted strip and an adhesive coated area on the other tray for receiving blades or pins, and the like. In this case, reliance is made on the adhesive properties of the adhesive layer to hold the sharps and while counting provision is made using the slotted blocks, there is no counting provision for bulk items such as blades or pits.
A further SANDER Patent, US. 4,318,473 issued March 9, 1982, provides a device that is specifically directed to removing surgical blades from the holder and disposing of them. Once 27 again, however, a magnetic sheet is adhesively secured to the inside surface of the single receiving tray that is provided.
In contradistinction to all of the above, the present invention provides a deformable but semi-rigid closable container issue for receiving and disposing of surgical sharps following their use in a surgical procedure, where the container is formed of a relatively thin sheet-like material having a bottom and a top each of which has a tray formation therein, such that one of` the trays -- usually in the bottom -- has a lip upstanding from a rim that surrounds it, which lip is received in the other tray, so as to close the container. living hinge is formed between the bottom and top of the container. At least one of the tray formations has a substantially flat surface over the major portion thereof, and a magnetic material is adhered to the flat surface on the outside thereof -- the outside being determined when the container is closed. The design of the container according to the present invention, has been particularly adapted for continuous vacuum-forming processes from sheet plastic material; and indeed the container may be vacuum-formed, cut or stamped foul the sheet, be printed with counting indicia or a grid, have magnetic material placed on the outside surface of both tray formations, and have a foam material placed into one of the tray formations -- all of the above not necessarily in the order stated -- and then be placed in an outer package for sterilization, all in the same machine. By so doing, the costs of production of the container are less, and the risk of damage to it are also less, thereby resulting in a semi-rigid container that may be easily used for receiving and counting surgical sharps, which may be closed and reopened if necessary, and disposed of, with a minimum of handling and a maximum of safety 27 as to possible contact by the hands of anyone handling the container with the sharps therein, and with no risk of contamination of surgical instruments such as needle holders that may enter the container from time to time during the surgical procedure.

sty BRIEF DESCRIPTION Ox THE DRAWINGS:
The specific features and advantages of the present invention are discussed in greater detail hereafter, with respect to an embodiment which is illustrative of the invention, and it shown in the accompanying figures, in which:
Figure 1 is a perspective view of a container in the open position and in use;
Figure 2 is a section in the direction of arrows 2-2 in Figure 1, with the addition of a foam insert; and Figure 3 shows the use of the sharps container together with a sharps organizer.
DESCRIPTION OF THE PREFERRED EMBODIMENTS:
The closable container 10 that is shown in Figures 1 and 3 of the drawings is one which, as noted, is intended particularly for receiving and disposing of surgical sharps following their use in a surgical procedure. The surgical sharps may be suture needles, blades, pins, or hypodermic needles, and they are usually magnetizable.
The closable container of the present invention is intended generally to be vacuum formed using a continuous vacuum-forming process from a relatively thin sheet-like material such as extruded polystyrene sheet, but other materials may also be used provided that they are capable of withstanding a gamma-radiation sterilization procedure or other sterilization procedure as may be required by certain surgical product acceptance specifications, without breaking down; and providing 27 also that the material is not one which will puncture or cut easily in the event of movement of any of the sharps within the container during handling for disposal.
The container generally has a bottom 12 and a top 14, I
with a bottom tray formation 16 and a top tray formation 18 in them, respectively. A living hinge 20 is formed between the bottom and top 12 and 14, and is such that it has elastic memory so that the container stays usually in its open position with the bottom and top trays 16 and 18 presented for sharps-receiving purposes. In such manner, therefore, the indicia for counting are also presented, having been printed in the container or on the foam placed in one of the trays of the container as discussed hereafter.
In general, the container is formed having a lip 22 which is upstanding from a rim 24 that is formed around one of the tray formations -- in this case, the bottom tray formation 16. The other tray formation -- in this case, the top tray formation 18 -- has a mating recess which is specifically indicated at 26 to mate to the lip 22, so that when the top 14 is closed over the bottom 12, the upstanding lip 22 mates to the recess 26 and the container is held together in a closed condition, with no possibility of sharps contained within extending to the outside.
At least one of the tray formations, in most cases both of the tray formations, has a substantially flat surface over the major portion thereof, as indicated at 28 and 30 in the bottom and top tray formations 16 and 18, respectively.
Also, at least one of the tray formations -- and in most cases, both tray formations -- has a magnetic material 32 or 34 adhered to the flat surface 28 or 30, respectively, on the 27 outside thereof -- that is, on the outside surface of the respective tray formation when the container is closed. In other words, the magnetic material 32,34 is not on the inside of the tray formation, and is therefore not in a position to be in direct contact with any surgical instruments or implements that l~lSG~8 may touch the inside of the container such as for purposes of disposing of sharps from a needle holder.
The magnetic material 32,34 may be a rubber like or plastic sheet material that is loaded Whitehall magnetized powder, and is readily available in the market. By placing the magnetic Material on the outside of the container, physically removed and away from the inside surface of the tray formations where the sharps will be retained, and removed therefrom by the thickness of the relatively thin sheet-like plastic or other material from which the container has been vacuum formed, several specific advantages are gained. They include the fact that there is no danger of magnetic dust being removed from the magnetic material -- as is the case in all of the prior art -- which dust may contaminate surgical implements such as needle holder and possibly may also contaminate the surgical wound in the patient.
Moreover, while there is sufficient magnetic strength to retain the surgical sharps in place when they have been disposed of into the tray formations of the semi-rigid container, there is not a high magnetic strength that may transfer to the surgical instruments where it is sometimes not advisable or is unwanted --such as in instruments that may be used in or near heart pacemakers or other sophisticated electronic appliances that may be implanted within the patient's body. Yet a further advantage over the prior art that is obtained by placing the magnetic material on the outside of the container is that there is no visual interference of the magnetic material with the counting 27 grid or indicia, and no possibility of surgical sharps, such as a pin, falling into a groove formed in the magnetic material and therefore being out of sight for counting purposes.
Thus, there may be printed indicia such as those that S6~8 are shown at 36 or I in the bottom of the tray formation 16 and 18, respectively; so that sharps such as those shown at 40 or 42 May be placed in the indicated area for ease of` counting. It is obvious that the scrub nurse needs only to look at the number of the last sharp that was placed to deterlnine the total number that have been placed. The indicia 38 may have a different appearance than the indicia 36, such as for purposes of retaining and counting small suture needles or the like.
There is generally a rim 44 that is formed in the top 14 around the top tray formation 18, so that Winnie the container is closed the rims 44 and 24 face each other; and so that the living hinge formation 20 is an extension of the inner rims 24 and 44 along one side of each of the bottom and top 12,14. There is thereby formed an enclosure which is complete on all sides and surfaces, for the retention of surgical sharps within the cavity thus formed.
By the structure of the present invention, having the lacing rims and the upstanding lips received in a mating recess a distinct advantage is gained. That is if it is necessary that scrub nurse or surgeon must open the container once it is closed, and of course Chile still wearing surgical gloves, they may do so by applying sideways pressure in the direction of arrows 46,48 against the outer walls of the bottom tray formation 16. This releases the mating relationship of the lip 22 to the recess 26; and the elastic memory of the living hinge 20 will ensure that the container will open -- that is, that the rims 24 27 and 44 will part from each other at the side of the container opposite the living hinge, so that they may then be more easily separated and the container thereby opened.
Referring now to Figure 3, a surgical sharps receiver/container 10 is shown, being secured to an organizer 50 ~J,5658 such as by an adhesive strip 52. The organizer 50 May itself, be secured to a surgical drape by an adhesive strip that may be placed on the back side of the organizer, not shown. The organizer 50 may be provided in association with the sharps container 10 so as to organize the sutures prior to their use.
Prepackaged or loose sutures may be placed in the longitudinal pockets ~4,56,5~ that are formed by the plurality of convolutions such as 60,62,64 that are folded in such a manner that each succeeding convolute and each succeeding pocket is slightly below and at the front face of the one above it. the provision of the organizer 50 gives the advantage that an additional towel need not be used; and since surgical towels have a much higher capital cost than the organizer and are required to be laundered at an additional cost I- which probably exceeds the capital cost of the organizer itself-- there may be considerable cost savings.
One of the features of the present invention is that the closable container 10 may be formed in apparatus that, in a continuous manner, forms the container and many others like it in a roll of plastic material; and thereafter cuts and stamps each container into its own individual piece, adheres magnet strips and foam blocks (as would be previously determined for the precise manufacturing steps to be taken at any time), prints on or into the container, and then seals each container into an outer package for sterilization and further shipping or other handling.
The semi-rigid closable container for receiving and 27 disposing of surgical sharps, according to the present invention may be manufactured in standard form, fill and seal machinery, from continuous rolls of sheet thermoplastic material. In the present case, the vacuum forming, and placing into an outer ~3!LS65~
pouch takes place in the same machinery of` the sort that is commonly provided for packaging medical, drug and cosmetic products such as prepackaged swabs and dressings, syringes, catheters, implements such as scissors and razors, bandages, gloves, etc. The other steps, that may include any or all of printing, foam block insertion, magnetic layer laminating and special die-stamping or cutting, may also be (and are generally) performed at additional stations that are installed in the same machinery, and that work with the same timing cycles as the other JO operations. Therefore, the packaged container which is still in its open condition, may be sterilized using conventional gamma-radiation or other sterilization techniques.
Thus, the present invention provides for a method of forming the closable container which comprises at least the steps of:
(a) continuously vacuum forming an open container formation having a top and a bottom, and a living hinge between them, and having tray formations formed in the top and bottom with mating lip and recess formations, and having substantially flat surface over the major portion of at least one of the tray formations;
and b) at a different station in the same machine, cutting the continuous line of containers and securing a magnetic material to the substantially flat surface or surfaces on the outside thereof -- the outside being that which will be the outside surface when the container is closed.

27 c) Likewise, in the same machine, counting indicia or grids may be printed or screened in the appropriate positions, or such other written matter may be applied to any surface of the container as required and as the physical capabilities of the machine may permit.

~1565~3 d) Still further, and at a different station in the same machine, the loam material 66 may be placed in one of the tray formations 16 or I on the inside thereof, as determined when the container is closed.
The description above has been directed to a specific embodiment US described and illustrated, but is general as to a closable, semi-rigid container for receiving and disposing surgical sharps, as more specifically claimed hereafter.

Claims (12)

WHAT IS CLAIMED IS:

1. A disposable and closable container for receiving and disposing surgical sharps following their use in a surgical procedure, wherein:
said container is formed of deformable sheet-like material and has a bottom and a top with a bottom tray formation and a top tray formation, respectively, wherein one of said tray formations has a lip upstanding from a rim, and the other of said tray formations has a mating recess to releasably receive said lip and to mate thereto so as to close said container:
said bottom tray and top tray formations are joined together by a living hinge formed between them:
at least one of said tray formations has a substantially flat surface over the major portion thereof: and a magnetic material is adhered to said flat surface on the outside thereof as determined when said container is closed.

2. The container of Claim 1, when formed by a continuous vaccum-forming process from sheet plastics material, and cut therefrom into single pieces.

3. The container of Claim 2, wherein said lip extends around the entire periphery of said bottom tray formation, and said top tray formation is formed with an upwardly extending, when closed, recess into which said lip is received when said container is closed.

4. The container of Claim 3, wherein said bottom and top tray formations are surrounded by rims which face each other, and said living hinge is formed as an extension of a rim along a side of each of said bottom and said top.

5. The container of Claim 4, wherein each of said bottom and top tray formations has a substantially flat surface over the major portion thereof.

6. The container of Claim 5, wherein a layer of foam material is adhered to one of said bottom or top tray formations, on the inside thereof when said container is closed.

7. The container of Claim 5, wherein each of said bottom and top tray formations has a magnetic material adhered to its respective flat surface on the outside thereof when said container is closed.

8. The container of Claim 5, 6 or 7, when provided open and flat in an outer package for sterilization.

9. The container of Claim 1, when provided together with a sharps counting organizer which comprises a structure having a plurality of convolutions folded in such a manner that each succeeding convolute is slightly below and at the front face of the one above it.

10. The method of forming a disposable and closable container for receiving and disposing surgical sharps following their use in a surgical procedure, comprising the steps of:
continuously vacum forming an open container formation where each containers has a bottom and a top, and a living hinge between said bottom and said top, and having a tray formation in each of said bottom and top with a lip upstanding from a rim of one of said tray formations and a mating recess to releasably receive said lip formed in the other of said tray formations, and where at least one of said tray formations has a substantially flat surface over the major portion thereof;
at a different station in the same machine, cutting the continuously formed containers into individual containers, and securing a megnetic material to at least one of said substantially flat surfaces on the outside of each container as determined when said container is closed, and inserting each finished container into an outer pouch for sterilization of said container and outer pouch elsewhere.

11. The method of Claim 10, further comprising, at a different station in the same machine, the step of printing or screening indicia or such other written matter on any surface of the container as is required.

12. The method of Claim 10, further comprising, at a different station in the same machine, the step of adhering a layer of foam material to one of said tray formations, on the inside thereof when said container is closed.