METHODS AND SYSTEMS FOR HOLDING SURGICAL INSTRUMENT COUNT SHEETS

Abstract

The disclosure includes systems and methods for hospital based sterilization of surgical instruments. An exemplary system includes a wrapped sterilization tray or container defining at least one opening to permit a sterilant to pass therethrough and least one surgical instrument disposed in the sterilization tray. The system still further includes a count sheet holder disposed on the sterilization wrap or container. The count sheet holder defines a compartment for receiving a count sheet and means for attaching the count sheet holder to the sterilization container or wrapped tray.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application claims the benefit of priority to U.S. Provisional Patent Application No. 61/360,975, filed Jul. 2, 2010. The aforementioned patent application is incorporated by reference herein in its entirety.

BACKGROUND

1. Field of the Disclosure

The present disclosure relates to methods and systems for sterilizing surgical instruments and related equipment. Particularly, the present disclosure is directed to improved systems and methods for sterilization by sequestering count sheets in locations that are easily accessible to hospital personnel.

2. Description of Related Art

Open top surgical trays are conventionally wrapped in a sterilization wrap which is generally a non-woven fabric (but can be a woven textile fabric) with surgical instruments inside to form what is typically referred to as a sterilization pack. By way of further example, a rigid sterilization container with a lid may also be used, sometimes referred to as a container. Such containers are generally rigid and are not wrapped The sterilant penetrates the container through a filter on the lid, and this filter also serves as a sterile barrier. Once a sterilization pack or container has completed a sterilization cycle, it may be removed from the sterilizer and stored for future use during surgery.

Surgical instrument trays and containers are generally sterilized using steam or another gas. This gas is commonly referred to as the sterilant. The contents of the tray or container, such as surgical instruments, are sterilized by way of the sterilant gas contacting and sterilizing the instruments. Sterilization of surgical tools including scalpels, scissors and clamps may be thus accomplished in a known manner by placing the tools in a sterilization tray (or container), wrapping the tray with a sterilization wrap to form a sterilization pack and then placing the pack or container into a sterilizer.

Persons have recognized that count sheets can cause problems in sterilization. Count sheets, sometimes referred to as inventory sheets, surgical instrument count sheets and the like, are sheets of paper (such as 8.5×11 inch sheets of paper) that are printed out in hospital sterilization departments that list the contents of each wrapped sterilization tray or container.

Count sheets sometimes accompany instruments in the sterilization tray or container. While these sheets are sterilized with the surgical instruments in the tray under such circumstances, ink and other chemical contaminants from the count sheet can be deposited on the contents of the tray, including surgical instruments. In addition, paper material from the count sheet can also be deposited on the instruments. Either of these conditions is in contravention to certain aspects of the AAMI standards and the AORN Recommended Practices, which are incorporated herein by reference in their entireties. This can result in toxic chemical contamination or other contamination, possibly endangering the health and safety of the patient. While those of skill in the art can attempt to remedy this situation by placing the count sheet in packaging such as a paper bag, peel pack or the like within the sterilization pack or container, this still requires the package to be opened to confirm the contents of the container, which simultaneously compromises the sterility of the instruments, possibly requiring re-sterilization.

It has also been standard practice to attempt to attach count sheets to the exterior of sterilization containers and wrapped sterilization packs. With respect to containers, some have stapled the count sheet itself around a handle of the container and run both through a sterilization cycle. This can unduly damage the count sheet, to say nothing of possibly introducing one or more staples into the OR that may not be noticed and accounted for. Similarly, some have tried to tape the count sheet directly to the sterilization wrap. This can damage the count sheet, but removal of the tape from the wrap can tear the wrap, compromising sterility of the sterilization pack, thereby requiring re-sterilization. Some have attempted to tape count sheets to sterilization wraps inside of paper bags, but this presents the same problem with tearing the wrap, and presents the additional disadvantage of not being able to view the count sheet in any respect without tearing the bag and removing the count sheet from the bag.

Some have tried to place count sheets in what are commonly referred to as “peel packs”, which include a transparent plastic film on a breathable paper backing. The peel pack is then attached typically to the wrap of a sterilization pack with tape. However, this can lead to a number of problems. First, it should be noted that the peel pack is typically placed with the transparent side up, thereby possibly preventing sterilant from infiltrating the peel pack, thereby possibly preventing sterilization of the count sheet. This can lead to a sense of false security of sterility of the count sheet. If the peel pack is later opened in the sterile field of the Operating Room (“OR”), the sterile field is compromised, thereby jeopardizing the procedure, the patient, and/or generally resulting in delaying the procedure until the sterile field can be reestablished, which typically requires all instruments in the tray to be re-sterilized. Use of the peel pack is also inconvenience because it requires tape to be peeled off of the wrap of the sterilization pack, which can tear a hole in the wrap, and compromise the sterility of the pack once sterilized.

As will be appreciated from the above discussion, the approaches present in the art are inadequate for a variety of reasons. The present disclosure provides a solution for these problems.

SUMMARY OF THE DISCLOSURE

The purpose and advantages of the present disclosure will be set forth in and become apparent from the description that follows. Additional advantages of the disclosed embodiments will be realized and attained by the methods and systems particularly pointed out in the written description hereof, as well as from the appended drawings.

To achieve these and other advantages and in accordance with the purpose of the disclosure, as embodied herein, in one aspect, the disclosure includes a system for hospital based sterilization of surgical instruments. The system includes a sterilization tray defining at least one opening to permit a sterilant to pass therethrough and a plurality of sides, wherein the bottom and plurality of sides cooperate to define a compartment for receiving surgical instruments to be sterilized. The system further includes at least one surgical instrument disposed in the sterilization tray, a sterilization wrap wrapped around the sterilization tray, the sterilization wrap being made from a breathable material adapted and configured to permit sterilant to pass through the wrap and through the tray, and a count sheet including a listing describing the at least one surgical instrument disposed in the sterilization tray. The system still further includes a pouch-shaped count sheet holder disposed on the sterilization wrap. The count sheet holder includes a first sheet of material, a second sheet of material disposed on and attached to the first sheet of material proximate the perimeter of the first and second sheets to define an elongate opening proximate a peripheral edge of the first sheet of material of the count sheet holder. The opening is in communication with a generally rectangular compartment defined between the first and second sheets of material for receiving the count sheet. The count sheet holder further includes a fastener for attaching the count sheet holder to the sterilization wrap.

In another aspect, a peripheral edge of the second sheet of material can extend beyond the peripheral edge of the first sheet of material to form an overhang, such that the elongate opening proximate the peripheral edge of the first sheet of material of the count sheet holder is located behind the second sheet of material. If desired, the overhang can include adhesive disposed on an inner face of the overhang, and may be covered with a removable covering that can be removed to expose the adhesive, such that the adhesive, when exposed, causes the overhang adhere to the sterilization wrap when pressed against the wrap after the count sheet is inserted in the count sheet holder, thereby preventing access to the count sheet. Preferably, the count sheet holder then further includes a removable tamper evident strip that, when removed, provides access to the count sheet and visual indication that the count sheet holder has been compromised.

In accordance with a further aspect, the fastener can be applied to an outwardly disposed face of the first sheet of material. The fastener preferably includes pressure sensitive adhesive applied to the outwardly disposed face of the first sheet of material. The count sheet holder can further include a removable protective layer of material disposed on top of the pressure sensitive adhesive. In another embodiment, when the sterilization wrap comprises a non-woven material, the fastener can include a plurality of hooks adapted and configured to mate directly with the non-woven material of the wrap to hold the count sheet holder in place.

In accordance with another embodiment, the perimeter of each of the first and second sheets defines four peripheral sides, wherein the first layer and second layer of material are joined about their periphery at three of the four sides, such as by a heat seal, an ultrasonic weld, adhesive, and the like. In one embodiment, the count sheet holder can be formed from a single folded sheet of material that is joined on two parallel sides by a seal, wherein the two parallel sides are separated by a third side formed by a fold line. Preferably, the first sheet of material is at least partially transparent to permit the contents of the generally rectangular compartment of the count sheet holder to be viewed from outside the count sheet holder when the count sheet holder is mounted on the sterilization wrap.

In a further aspect, the count sheet holder preferably includes indicia thereon to inform a user of the count sheet holder that the count sheet is not to be considered to be sterile so as to avoid contamination of the sterile field of an operating room. In another embodiment, a peripheral edge of the second sheet of material of the count sheet holder extends beyond the peripheral edge of the first sheet of material to form a foldable flap adapted and configured to be folded over the elongate opening. The fastener can accordingly be applied to an outwardly disposed face of the second sheet of material. In another embodiment, the count sheet holder can include a zipper closure disposed proximate the elongate opening for facilitating closure of the count sheet holder. In one embodiment, the count sheet holder can include material that permits writing thereon. The first and second sheets of the count sheet holder can be comprised of polypropylene and/or other suitable materials, such as paper. The fastener can include an adhesive that in turn includes acrylic copolymer.

In accordance with further aspects, the count sheet holder can be disposable or reusable. For example, the count sheet holder can be adapted and configured to be reused in a plurality of sterilization cycles. If desired, the sterilization wrap can include a textile fabric or a melt blown spun bonded polypropylene sterilization wrap.

The disclosure further provides a method of sterilizing surgical instruments in a hospital sterilization department. The method includes providing a sterilization tray defining at least one hole therethrough to permit a sterilant to pass therethrough and a plurality of sides, wherein the bottom and plurality of sides cooperate to define a compartment for receiving surgical instruments to be sterilized. The method further includes disposing at least one surgical instrument in the sterilization tray and wrapping a sterilization wrap around the sterilization tray. The sterilization wrap is made from a breathable material adapted and configured to permit sterilant to pass through the wrap and through the tray. The method still further includes providing a count sheet including a listing describing the at least one surgical instrument disposed in the sterilization tray, and disposing a pouch-shaped count sheet holder on the sterilization wrap. The count sheet holder includes a first sheet of material, a second sheet of material disposed on and attached to the first sheet of material proximate the perimeter of the first and second sheets to define an elongate opening proximate a peripheral edge of the first sheet of material of the count sheet holder. The opening is preferably in communication with a generally rectangular compartment defined between the first and second sheets of material for receiving the count sheet. The count sheet holder further includes a fastener for attaching the count sheet holder to the sterilization wrap, and disposing the count sheet in the count sheet holder to form a sterilization package. The method further includes the step of sterilizing the sterilization package until the at least one surgical instrument is sterilized.

In accordance with further aspects of the method, the count sheet holder can be applied prior to or after the sterilizing step, as desired. The sterilant can be steam, plasma, hydrogen peroxide or ozone. In another aspect, the count sheet can be made from a cellulose-based material or non-cellulose based material. If desired, the count sheet holder can be disposed after the sterilization step, or can be reused in a subsequent sterilization operation.

The disclosure further provides a system for hospital based sterilization of surgical instruments for sterilization containers. The system includes a sterilization container having a bottom portion and a top portion, at least one of the bottom portion and the top portion defining at least one hole therethrough to permit a sterilant to pass therethrough, wherein the bottom portion and top portion cooperate to define an interior compartment for receiving surgical instruments to be sterilized. The system further includes at least one surgical instrument disposed in the sterilization container, and a count sheet including a listing describing the at least one surgical instrument disposed in the sterilization container. The system also includes a count sheet holder disposed on the sterilization container. The count sheet holder includes a cover portion, a body portion, a hinge attaching the cover portion to the body portion, wherein the body portion and cover portion cooperate to define a compartment for containing a count sheet when the cover is closed, and a fastener for fastening the count sheet holder to the sterilization container.

In accordance with a further aspect, the cover portion of the count sheet holder can include a front face, a back face, and a perimeter bead that is received by a complementary bead defined in body portion. The count sheet holder can further include at least one outwardly extending tab on at least one of the cover portion and body portion to facilitate opening or closure of the count sheet holder. If desired, the count sheet holder can further include at least one vent to permit air or other gas to be evacuated from the compartment. In one aspect, the count sheet holder can include an interlocking bead along two parallel sides of the count sheet holder. The fastener of the count sheet holder can include a hook and loop fastener for removably attaching the count sheet holder to the sterilization container. In one embodiment, the fastener of the count sheet holder includes a foam tape for removably attaching the count sheet holder to the sterilization container, preferably an acrylic foam type, such as VHB™ foam tapes, commercially available from The Minnesota Mining & Manufacturing Co. (“3M”) of St. Paul, Minn.

Preferably, the sterilization container includes at least one handle or latch and the fastener of the count sheet holder includes a strap extending from the count sheet holder for attaching to the handle or latch of the sterilization container. The strap can include a tip located at a distal end of the strap having at least one barb for engaging an opening defined in the strap. The opening can have any desired shape, such as a straight, curve or cross-shape. If desired, the count sheet holder can include a snap closure (e.g., using an interference fit) to maintain the count sheet holder in a closed condition. The count sheet holder can be made from a variety of materials, such as polypropylene, polyethylene terephthalate or silicone, among others. Preferably, the count sheet holder is at least partially transparent to permit the contents of the count sheet holder to be viewed from outside the count sheet holder when the count sheet holder is mounted on the sterilization container. The count sheet holder can include indicia thereon to inform a user of the count sheet holder as to proper use of the count sheet holder. The count sheet holder can be disposable, or be adapted and configured to be reused in a plurality of sterilization cycles.

The disclosure further provides a method for sterilizing surgical instruments in a hospital. The method includes providing a sterilization container having a bottom portion and a top portion, at least one of the bottom portion and the top portion defining at least one opening to permit a sterilant to pass therethrough, wherein the bottom portion and top portion cooperate to define an interior compartment for receiving surgical instruments to be sterilized. The method further includes disposing at least one surgical instrument in the sterilization container and providing a count sheet including a listing describing the at least one surgical instrument disposed in the sterilization container. The method also includes disposing a count sheet holder on the outside of the sterilization container. The count sheet holder has a body portion defining a compartment for containing a count sheet. The method further includes the steps of disposing the count sheet in the count sheet holder to form a sterilization package, and sterilizing the sterilization package until the at least one surgical instrument is sterilized.

In accordance with further aspects of the method, the count sheet holder can further include a cover portion, a hinge attaching the cover portion to the body portion, wherein the body portion and cover portion cooperate to define the compartment for containing a count sheet when the cover is closed, and a fastener a for fastening the count sheet holder to the sterilization container. The count sheet holder can be applied prior to, or after, the sterilizing step. The sterilant can be steam, plasma, hydrogen peroxide or ozone. The count sheet can be made from a cellulose-based material or non-cellulose based material, such as spun bonded polypropylene, sold under the trade name of Tyvek®. The count sheet holder can be disposed after the sterilization step, or reused in a subsequent sterilization operation.

In accordance with still further aspects of the method, the sterilization container can include at least one handle, the fastener of the count sheet holder can include a strap extending from the count sheet holder for attaching to the handle of the sterilization container, and the disposing step can include directing the strap of the fastener of the count sheet holder around the handle of the sterilization container to attach the count sheet holder to the sterilization container. If desired, the body of the count sheet holder can include an elongate tube closed on a first end and open on the second end. The count sheet holder can accordingly further include a cover portion adapted and configured to attach to the second end of the body portion and a fastener a for fastening the count sheet holder to the sterilization container. The elongate tube can have a rounded, rectangular or hexagonal cross-section. The count sheet holder can further include a hinge attaching the cover portion to the body portion, wherein the body portion and cover portion cooperate to define the compartment for containing a count sheet when the cover is closed.

If desired, the step of disposing the count sheet in the count sheet holder can include rolling the count sheet holder into a cylindrical shape prior to inserting the count sheet into the body portion of the count sheet holder. Disposing a count sheet holder on the outside of the sterilization container can include attaching the count sheet holder to the container using a strap, a hook and loop fastener and/or an adhesive, among other means.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the embodiments disclosed herein.

The accompanying drawings, which are incorporated in and constitute part of this specification, are included to illustrate and provide a further understanding of the method and system of the disclosure. Together with the description, the drawings serve to explain the principles of the disclosed embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1(A) is an isometric view of a first representative embodiment of a count sheet holder in accordance with the present disclosure.

FIG. 1(B) is an isometric view of a second representative embodiment of a count sheet holder in accordance with the present disclosure.

FIG. 2 is an isometric view of a wrapped instrument set including an embodiment of a count sheet holder in accordance with the present disclosure.

FIG. 3 is an isometric view of a sterilization container including an embodiment of a count sheet holder in accordance with the present disclosure.

FIG. 4 is an isometric view of a sterilization container including a further embodiment of a count sheet holder in accordance with the present disclosure.

FIGS. 5-10 are various views of a further representative embodiment of a count sheet holder in accordance with the present disclosure.

FIG. 11 is a view of another representative embodiment of a count sheet holder in accordance with the present disclosure.

FIGS. 12-14 are various views of yet another representative embodiment of a count sheet holder in accordance with the present disclosure.

FIG. 15 presents various views of an alternative embodiment of a count sheet holder including parallel longitudinal engagement surfaces.

FIG. 16 illustrates another embodiment of a count sheet holder in accordance with the present disclosure.

DETAILED DESCRIPTION

Reference will now be made in detail to the present preferred embodiments of the disclosure, examples of which are illustrated in the accompanying drawings. The methods and corresponding steps of the disclosed embodiments will be described in conjunction with the detailed description of the systems.

The deficiencies in the art are set forth above. Applicants have invented new ways of addressing these problems, as embodied herein. In one aspect, the disclosure provides methods of providing a count sheet, securing the count sheet in a protective count sheet holder that defines an enclosure, and securing the count sheet holder to a wrapped sterilization tray or instrument container, and sterilizing tray or container. The enclosure is adapted and configured to protect the count sheet, but the count sheet is easily removable post-sterilization, thus decreasing the chances that the sterility of the wrapped tray or the container will be compromised. Thus, the sterility of the package is maintained while permitting access to the count sheet after sterilization, yet the sterility of the surgical instruments or other tray/container contents is not compromised. The enclosure is preferably sufficiently durable to survive the sterilization process, and should be able to protect and contain the count sheet during sterilization, and during the trip from the sterilization department of the hospital to the operating room (“O.R.”). Preferably, the enclosure includes a variety of indicia including, for example, instructions for use and an indication that the contents of the enclosure are not sterile. This can be implemented in a variety of ways.

In accordance with one embodiment, a count sheet holder including an enclosure is provided for a count sheet that can be used with a wrapped sterilization tray or a container. For purposes of illustration, and not limitation, an exemplary count sheet holder 100 is illustrated in FIGS. 1-3. As illustrated in FIG. 1(A), count sheet holder 100 is provided in the form of a pouch formed from a first layer 110 of material disposed on a base, or second layer of material 120. If desired, the second layer 120 of material can include adhesive on its back side 122 that may be exposed by removing a further protective layer 130. As illustrated, first layer 110 and second layer 120 are joined about three of four sides in a bonding region 114 by various means (e.g., heat sealing, adhesive, solvent welding, ultrasound welding, etc.) and defining a generally rectangular compartment 118 therein and leaving an elongate opening 112 along one edge to permit a count sheet 170 to be inserted into the compartment 118 of the count sheet holder 100. Indicia 116 of various types may be provided to facilitate proper use of the enclosure 100. Preferably, indicia 117 of non-sterility of the count sheet is also provided to inform hospital personnel that the count sheet is not to be considered to be sterile, thereby minimizing the chances that the sterile field in the OR will be compromised by the count sheet. If desired, a foldable flap (shown in dashed lines as 143 with an adhesive patch 144) can be provided to fold over opening 112 after the count sheet is inserted. By way of another example, a zipper closure(not shown) can be provided along opening 112 to maintain count sheet holder 100 in a closed condition.

As further illustrated in FIG. 1(B), an alternative count sheet holder 100′ is provided in the form of a pouch formed from a first layer 110′ of material disposed on a base, or second layer of material 120′. If desired, the second layer 120′ of material can include adhesive on its back side 122′ that may be exposed by removing a further protective layer 130′. As illustrated, first layer 110′ and second layer 120′ are joined about three of four sides in a bonding region 114′ by various means (e.g., heat sealing, adhesive, solvent welding, ultrasound welding, etc.) and defining a generally rectangular compartment 118′ therein and leaving an elongate opening 112′ along one edge to permit a count sheet 170′ to be inserted into the compartment 118′ of the count sheet holder 100′ along the direction of arrow “A”. Indicia 116′ of various types may be provided to facilitate proper use of the enclosure 100′. As illustrated, an overhang 145 of the top layer 110′ is provided to protect the edge of the count sheet 170′, and to facilitate the easy removal of the count sheet from the holder 100′. If desired, the overhang 145 can include adhesive disposed on an inner face 145a of the overhang, and may be covered with a removable covering 145b that can be removed to expose the adhesive, such that the adhesive, when exposed, causes the overhang adhere to the sterilization wrap when pressed against the wrap after the count sheet is inserted in the count sheet holder, thereby preventing access to the count sheet. Preferably, the count sheet holder then further includes a removable tamper evident strip 179 that, when removed, provides access to the count sheet and visual indication that the count sheet holder has been compromised. Alternatively, strip 179 can be a zipper closure that can permit selective opening and closing of the count sheet holder. In one embodiment, the count sheet holder can include material that permits writing thereon. The count sheet holder can use an adhesive such as a acrylic copolymer to attach it to a wrapped tray or a sterilization container.

After the adhesive is exposed, the count sheet holder 100 may be attached to the sterilization wrap of a package as illustrated in FIG. 2 or directly to the body of a sterilization container as illustrated in FIG. 3. As illustrated in FIG. 2, a sterilization tray is depicted wrapped in a KimGuard® type sterilization wrap, wherein a corner 152 of the wrap 150 is wrapped and tucked underneath the package. While not preferred, enclosure could be provided with an elongate member, cord, or tape 119 that can be wrapped into the sterilization wrap to secure the enclosure to the package, but still leaving the body of the count sheet holder exposed and visible.

By way of further example, in contrast to a wrapped set, a container 160 is illustrated in FIG. 3 having a bottom portion 162 for receiving a plurality of instruments and a removable cover portion 164 for maintaining closure of the container. While not preferred, an adhesive backed count sheet holder 100 can be used in connection with a container as illustrated in FIG. 3, but preferably a count sheet holder similar to embodiment 200 is used, described in detail below.

Count sheet holder 100, 100′ can be made in a variety of ways and from a variety of materials. Preferably, count sheet holder 100 is made from a highly durable material that can withstand the conditions of sterilization (e.g., high humidity and 275° F. for about twenty minutes, with a total cycle time of about an hour including heat up and cool down), and handling from the sterilization department of a hospital to the O.R. For example, count sheet holder 100 can be made from layers of polypropylene (“PP”), paper, TYVEK® type sheet material, and the like. If adhesive is used to secure the count sheet holder 100 to a sterilization wrap or tray, various types of adhesive can be used, including acrylic copolymer, hot melt adhesive, and the like. Count sheet holder 100 can be provided in a variety of shapes, such as square or elongate and rectangular. As to dimensions, enclosure is preferably about 4.75 by about 3.25 inches overall, although other dimensions may be used as a matter of preference. The material of count sheet holder 100 preferably permits writing thereon (such as with permanent marker). For steam sterilization, count sheet holder 100 is preferably applied prior to sterilization. For plasma, hydrogen peroxide or ozone sterilization, count sheet holder 100 is preferably affixed post-sterilization, as paper material inside enclosure may cause the sterilization unit to abort, particularly if an adhesive or zipper closure is not used. When a wrapped container is delivered to the O.R., the circulating nurse preferably removes the count sheet 170 from the count sheet holder count sheet holder 100 rather than removing the enclosure from the wrap 150, as the wrap 150 could be torn in the process, thereby compromising the sterility of the contents of the sterilization tray. However, it will be appreciated that count sheet holder can nonetheless be applied and filled with count sheet holder before or after sterilization, as desired. The count sheet can be made from a cellulose-based material or non-cellulose based material, such as spun bonded polypropylene, sold under the trade name of Tyvek®. Any count sheet holder described herein can be disposed after the sterilization step, or reused in a subsequent sterilization operation.

A second embodiment of a count sheet holder is illustrated in FIGS. 4-10, which is preferably configured for use with a sterilization container, rather than a wrapped sterilization tray. As illustrated in FIG. 4, count sheet holder 200 is provided that is configured to attach to a handle 166 of a container 160. The particular configuration of count sheet holder 200 is illustrated in FIGS. 5-10. As can be seen, count sheet holder 200 includes a cover portion 210 attached to a body portion 220 by a hinge member 230 that cooperate to define an enclosure 240 for containing a count sheet 170. Cover portion 210 includes a front face 208, a back face 212, and a perimeter bead 214 that is received by a complementary bead 224 in body portion 220, more clearly illustrated in FIG. 10. It will be appreciated that other types of suitable closures can be used. A plurality of vents 218 are provided to permit air or other gas to be evacuated from compartment 240. One or more tabs 216 can be provided to facilitate opening count sheet holder 200 after sterilization, and can also act to hold the enclosure closed if suitably configured, such as with a buckle or the like.

A zip tie, elastic loop or further attachment strap can be used to attach count sheet holder 200 to tray 160. For example, a strap with hook and loop fastener can be provided to selectively attach to holder 200 and to a handle 166 of a container 160. Alternatively, an attachment tab 250 can be provided for attaching holder 200 to a sterilization container, wherein a tip 252 is provided at a distal end of tab 250 having a plurality of barbs 254 for engaging opening 256 in tab after tab 250 is wrapped, for example, about the handle 166 of container 160. FIG. 7 illustrates back 228 of body portion and FIG. 8 illustrates one of the vents 218. FIG. 9 is a cross-sectional view illustrating enclosure/compartment 240. Count sheet holder 200 can be made from a variety of materials, including silicone rubber and other materials such as a thermoplastic elastomer or polypropylene. Count sheet holder 200 is preferably of dimensions of about 3.25 inches by about 2.5 inches overall, such that holder 200 is suitable to contain a 8½ by 11 inch sheet of paper folded into a smaller size. It will be appreciated that count sheet holder 200 is preferably reusable, whereas count sheet holder 100 is preferably a disposable item that is disposed with the sterilization wrap.

A further embodiment of a count sheet holder 300 is illustrated in FIG. 11. Count sheet holder 300 is a generally envelope-like structure made from a preferably transparent first layer 310 bonded to a preferably transparent second layer 320 via a peripheral seal 314 defining an opening 312 for receiving a count sheet 170. Indicia relating to use 316 and non-sterility of the count sheet 317 can also be provided. A strap 360 is routed through two openings 350 after insertion of the count sheet and used to attach the holder 300 to the handle 166 of a sterilization container 160. Holder 300 can be made from a variety of materials and manners as described with respect to embodiments 100, 100′, which are preferably disposable and 200, which is preferably reusable. Accordingly, holder 300 may be configured to be disposable or reusable. If desired, strap 360 can be unitary with the holder 300 wherein the strap 360 can be routed around the handle, through openings 350, and then attached either to itself or another portion of holder 300.

For purposes of further illustration, and not limitation, FIGS. 12-14 present a further representative embodiment of a count sheet holder 400 in accordance with the present disclosure. Count sheet holder 400, as illustrated, is a generally rigid reclosable box. FIGS. 12-13 illustrate count sheet holder 400 in an open condition, while FIG. 14 illustrates count sheet holder in a closed condition.

As illustrated, count sheet holder 400 includes a cover portion 420 attached to a body portion 410 by a hinge 425 that attaches the cover portion to the body portion. The body portion 410 and cover portion 420 cooperate to define a compartment 430 for containing a count sheet (e.g., 475, FIG. 14(D)) when the cover is closed, and a fastener 440 for fastening the count sheet holder to a sterilization container (e.g., 160). FIG. 12(A) illustrates a plan view of the count sheet holder in an open condition illustrating the exterior planar surfaces 412, 422 of the cover portion 420 and base portion 410 of the count sheet holder 400. FIG. 12(B) illustrates a top view of the count sheet holder, particularly illustrating longitudinal edge walls 414, 424 of the base portion 410 and cover portion 420, respectively. FIG. 12(C) illustrates a side view of the count sheet holder of FIG. 12(A), illustrating a side view of strap 440 (discussed below) and lateral edge walls 416, 426 of the base portion 410 and cover portion 420, respectively.

The fastener for attaching the count sheet holder 400 to a sterilization container can comprise a strap 440 having a tip 445 located at a distal end 442 of the strap 440 having at least one barb 446 for engaging an opening 448 defined in the strap 440. As illustrated in FIG. 12(A), opening 448 is located in a proximal region 444 of the strap 440 proximate the body, or base portion 410 of count sheet holder. The opening 440 can have any desired shape, such as a straight, curved or cross-shaped. The particular illustrated shape is a cross shape, as illustrated in FIG. 13(F). The fastener of the count sheet holder can alternatively include a hook and loop fastener and/or adhesive tape 441 (FIG. 12(A)) for removably attaching the count sheet holder to the sterilization container. In one embodiment, the fastener of the count sheet holder includes a foam tape for removably attaching the count sheet holder to the sterilization container, preferably an acrylic foam type, such as VHB™ foam tapes, commercially available from The Minnesota Mining & Manufacturing Co. (“3M”) of St. Paul, Minn.

In accordance with a further aspect, the count sheet holder can include a snap closure 450 (e.g., using an interference fit) to maintain the count sheet holder in a closed condition. As illustrated in FIG. 14(E), base portion 410 includes a raised bead 456 along the upper outer edge of wall 416 that interfits with inwardly facing bead 458 that traverses the inner edge of wall 426. As such, when container is closed, beads 456 and 458 slide past each other while walls 416, 426 deform inwardly and outwardly, respectively until the beads snap into place, holding count sheet holder 400 closed. If desired, outwardly extending tabs 452, 454 can be provided so as to provide a means for a user to open count sheet holder 400 to retrieve count sheet 475 from within. If desired, the count sheet holder 400 can further include at least one vent 462 (FIG. 14(A) in any desired location to permit air or other gas to be evacuated from or introduced into the compartment 430.

By way of further illustration, FIG. 14(F) illustrates a perspective view of count sheet holder 400 in a closed condition illustrating cover portion 420 and strap 440 as well as indicia 490. FIG. 14(G) illustrates a perspective view of count sheet holder 400 in a closed condition illustrating base portion 410 and strap 440 as well as opening tabs 454 as well as side wall 414 and outer face 412 of base portion. FIGS. 14(H)-14(I) are perspective depictions of count sheet holder 400 in an open condition illustrating the inner and outer surfaces of cover portion 420 and base portion 410, as well as strap 440, hinge 425, walls 414, 416 and 424 as well as indicia 490 and tabs 452, 454.

FIGS. 14(J)-14(M) illustrate views of an alternative embodiment of count sheet holder 400′ that is the same as embodiment 400, but instead replaces strap 440 with adhesive patches 441 that include hook and loop fastener. Protective backing 441a is removed from patches 441 to permit count sheet holder 400′ to be attached, for example, to the wall or top of a sterilization container (preferably in a region with no holes in the container so as to not obstruct the passage of fluid therethrough). Count sheet holder 400′ can then be removed and reattached as desired by way of the hook and loop fasteners.

In another alternative embodiment, as set forth in FIG. 15, a count sheet holder 500 is provided that is essentially the same as count sheet holder 400, but that further includes an interlocking bead 515 along two longitudinal parallel sides of the count sheet holder. Specifically, FIG. 15(A) sets forth a plan view of count sheet holder 500 in a closed condition, wherein reference numerals parallel those of count sheet holder 400. FIG. 15(B) sets forth a sectional view along line A-A of count sheet holder 500 in FIG. 15(A), wherein the base portion 510 of the count sheet holder is interfitted with cover portion 520 by way of interlocking beads 515a, 515b. FIG. 15(C) sets forth an enlarged detail of the interfitting beads, which interfit in the same manner as beads 456, 458 of embodiment 400. It will be understood that such overlapping interfitting beads can be used around the entire perimeter of count sheet holders 400, 500, or around part of the perimeter in a continuous or interrupted (e.g., dashed) format.

FIG. 16 sets forth still a further exemplary embodiment 600 of a count sheet holder in accordance with the disclosure. Count sheet holder 600 is formed by an elongate tubular member 610 that defines an elongate compartment 620 therein. A cap 630 is further provided for mating with member 610 to define a closed compartment for receiving a rolled-up count sheet 675. A hinge 650 can be provided to provide registration to help close count sheet holder 600, or components 610, 630 can be separate. Alternatively, components 610, 620 can be joined by a tether 660 that can be routed around the handle of a sterilization container prior to joining cap 630 to member 610, thus simultaneously providing a means for attaching the count sheet holder 600 to a sterilization container. Preferably, a tether or strap 640 is provided that is attached at a first end 644 to member 610 and includes one or more hook and loop fastener or adhesive patches 646 to facilitate attachment of count sheet holder 600 to a sterilization container. Count sheet holder 600 can have a round cross-section, as shown, or any other desired shape, such as rectangular, elliptical, hexagonal, and the like.

Cap 630 can be attached to member 610 by any desired means, including an interference fit by closely matching the outer diameter of member 610 with the inner diameter 630 of cap, or by way of screw threads on cap and member 610 (not shown) or by way of a snap fit, wherein interior facing bosses 652 on the inside of cap snap over a continuous or intermittent boss 654 on open end 612 of member 610, opposite from the closed end 614 of member 610.

The count sheet holder 400, 500, 600 can be made from a variety of materials, such as polypropylene, polyethylene terephthalate, silicone, aluminum, tin, steel, nylon, other polymers and the like. Preferably, the count sheet holders described herein are at least partially transparent to permit the contents of the count sheet holder to be viewed from outside the count sheet holder when the count sheet holder is mounted on the sterilization container or wrapped set. The count sheet holders 400, 500, 600 can include indicia 490, 590, 690 thereon to inform a user of the count sheet holder as to proper use of the count sheet holder as described above. The count sheet holder can be disposable, or be adapted and configured to be reused in a plurality of sterilization cycles.

It will be appreciated that the disclosed exemplary count sheet holders securely hold count sheets outside of the sterile barrier of the sterilization tray, thereby shielding instruments and trays from foreign particles arising from the count sheets. It will be apparent to those skilled in the art that various modifications and variations can be made in the device and method of the present disclosure without departing from the spirit or scope of the disclosure. Thus, it is intended that the present disclosure include modifications and variations that are within the scope of the subject disclosure and equivalents.

Claims

1. A system for hospital based sterilization of surgical instruments, comprising:

a) a sterilization tray defining at least one opening to permit a sterilant to pass therethrough and a plurality of sides, wherein the bottom and plurality of sides cooperate to define a compartment for receiving surgical instruments to be sterilized;

b) at least one surgical instrument disposed in the sterilization tray;

c) a sterilization wrap wrapped around the sterilization tray, the sterilization wrap being made from a breathable material adapted and configured to permit sterilant to pass through the wrap and through the tray;

d) a count sheet including a listing describing the at least one surgical instrument disposed in the sterilization tray; and

e) a pouch-shaped count sheet holder disposed on the sterilization wrap, the count sheet holder including: i) a first sheet of material; ii) a second sheet of material disposed on and attached to the first sheet of material proximate the perimeter of the first and second sheets to define an elongate opening proximate a peripheral edge of the first sheet of material of the count sheet holder, wherein the opening is in communication with a generally rectangular compartment defined between the first and second sheets of material for receiving the count sheet; and iii) a fastener for attaching the count sheet holder to the sterilization wrap.

2. The system of claim 1, wherein the fastener is applied to an outwardly disposed face of the first sheet of material.

3. The system of claim 2, wherein a peripheral edge of the second sheet of material extends beyond the peripheral edge of the first sheet of material to form an overhang, such that the elongate opening proximate the peripheral edge of the first sheet of material of the count sheet holder is located behind the second sheet of material.

4. The system of claim 3, wherein the overhang includes adhesive disposed on an inner face of the overhang such that the adhesive causes the overhang adhere to the sterilization wrap when pressed against the wrap after the count sheet is inserted in the count sheet holder, thereby preventing access to the count sheet.

5. The system of claim 4, wherein the count sheet holder further includes a removable tamper evident strip that, when removed, provides access to the count sheet and visual indication that the count sheet holder has been compromised.

6. The system of claim 2, wherein the fastener includes pressure sensitive adhesive applied to the outwardly disposed face of the first sheet of material and the count sheet holder further includes a removable protective layer of material disposed on top of the pressure sensitive adhesive.

7. The system of claim 1, wherein the perimeter of each of the first and second sheets defines four peripheral sides, and further wherein the first layer and second layer of material are joined about their periphery at three of the four sides.

8. The system of claim 1, wherein the first sheet of material is at least partially transparent to permit the contents of the generally rectangular compartment to be viewed from outside the count sheet holder when the count sheet holder is mounted on the sterilization wrap.

9. The system of claim 3, wherein the count sheet holder includes indicia thereon to inform a user of the count sheet holder that the count sheet is not to be considered to be sterile so as to avoid contamination of the sterile field of an operating room.

10. The system of claim 1, wherein a peripheral edge of the second sheet of material extends beyond the peripheral edge of the first sheet of material to form a foldable flap adapted and configured to be folded over the elongate opening, and further wherein the fastener is applied to an outwardly disposed face of the second sheet of material.

11. The system of claim 1, wherein the count sheet holder further includes a zipper closure disposed proximate the elongate opening for facilitating closure of the count sheet holder.

12. A method of sterilizing surgical instruments in a hospital sterilization department, comprising:

a) providing a sterilization tray defining at least one hole therethrough to permit a sterilant to pass therethrough and a plurality of sides, wherein the bottom and plurality of sides cooperate to define a compartment for receiving surgical instruments to be sterilized;

b) disposing at least one surgical instrument in the sterilization tray;

c) wrapping a sterilization wrap around the sterilization tray, the sterilization wrap being made from a breathable material adapted and configured to permit sterilant to pass through the wrap and through the tray;

d) providing a count sheet including a listing describing the at least one surgical instrument disposed in the sterilization tray;

e) disposing a pouch-shaped count sheet holder on the sterilization wrap, the count sheet holder including: i) a first sheet of material; ii) a second sheet of material disposed on and attached to the first sheet of material proximate the perimeter of the first and second sheets to define an elongate opening proximate a peripheral edge of the first sheet of material of the count sheet holder, wherein the opening is in communication with a generally rectangular compartment defined between the first and second sheets of material for receiving the count sheet; and iii) a fastener for attaching the count sheet holder to the sterilization wrap;

f) disposing the count sheet in the count sheet holder to form a sterilization package;

g) sterilizing the sterilization package until the at least one surgical instrument is sterilized.

13. The method of claim 12, wherein the count sheet holder is disposed after the sterilization step.

14. The method of claim 12, wherein the count sheet holder is reused in a subsequent sterilization operation.

15. A system for hospital based sterilization of surgical instruments, comprising:

a) a sterilization container having a bottom portion and a top portion, at least one of the bottom portion and the top portion defining at least one hole therethrough to permit a sterilant to pass therethrough, wherein the bottom portion and top portion cooperate to define an interior compartment for receiving surgical instruments to be sterilized;

b) at least one surgical instrument disposed in the sterilization container;

c) a count sheet including a listing describing the at least one surgical instrument disposed in the sterilization container; and

d) a count sheet holder disposed on the sterilization container, the count sheet holder including: i) a cover portion; ii) a body portion; iii) a hinge attaching the cover portion to the body portion, wherein the body portion and cover portion cooperate to define a compartment for containing a count sheet when the cover is closed; and iv) a fastener for fastening the count sheet holder to the sterilization container.

16. The system of claim 15, wherein the count sheet holder further includes at least one outwardly extending tab on at least one of the cover portion and body portion to facilitate opening or closure of the count sheet holder.

17. The system of claim 16, wherein the count sheet holder further includes at least one vent to permit air or other gas to be evacuated from the compartment.

18. The system of claim 16, wherein the count sheet holder includes an interlocking bead along two parallel sides of the count sheet holder.

19. The system of claim 15, wherein the sterilization container includes at least one handle or latch and wherein the fastener of the count sheet holder includes a strap extending from the count sheet holder for attaching to the handle or latch of the sterilization container.

20. The system of claim 19, wherein the strap includes a tip located at a distal end of the strap having at least one barb for engaging an opening defined in the strap.

21. The system of claim 20, wherein the opening is cross-shaped.

22. The system of claim 15, wherein the count sheet holder includes a snap closure to maintain the count sheet holder in a closed condition.

23. The system of claim 15, wherein the count sheet holder is at least partially transparent to permit the contents of the count sheet holder to be viewed from outside the count sheet holder when the count sheet holder is mounted on the sterilization container.

24. A method for sterilizing surgical instruments in a hospital, comprising:

a) providing a sterilization container having a bottom portion and a top portion, at least one of the bottom portion and the top portion defining at least one opening to permit a sterilant to pass therethrough, wherein the bottom portion and top portion cooperate to define an interior compartment for receiving surgical instruments to be sterilized;

b) disposing at least one surgical instrument in the sterilization container;

c) providing a count sheet including a listing describing the at least one surgical instrument disposed in the sterilization container;

d) disposing a count sheet holder on the outside of the sterilization container, the count sheet holder having a body portion defining a compartment for containing a count sheet;

e) disposing the count sheet in the count sheet holder to form a sterilization package;

f) sterilizing the sterilization package until the at least one surgical instrument is sterilized.

25. The method of claim 24, wherein the count sheet holder further includes:

a) a cover portion; and

b) a fastener for fastening the count sheet holder to the sterilization container.

26. The method of claim 24, wherein:

a) the sterilization container includes at least one handle;

b) the fastener of the count sheet holder includes a strap extending from the count sheet holder for attaching to the handle of the sterilization container; and

c) the disposing step includes directing the strap of the fastener of the count sheet holder around the handle of the sterilization container to attach the count sheet holder to the sterilization container.

27. The method of claim 24, wherein the body of the count sheet holder includes an elongate tube closed on a first end and open on the second end, and the count sheet holder further includes:

i) a cover portion adapted and configured to attach to the second end of the body portion; and

ii) a fastener a for fastening the count sheet holder to the sterilization container.

28. The method of claim 25, wherein the count sheet holder further includes a hinge attaching the cover portion to the body portion, wherein the body portion and cover portion cooperate to define the compartment for containing a count sheet when the cover is closed.

29. The method of claim 24, wherein disposing the count sheet in the count sheet holder includes rolling the count sheet holder into a cylindrical shape prior to inserting the count sheet into the body portion of the count sheet holder.

30. The method of claim 29, wherein disposing a count sheet holder on the outside of the sterilization container includes attaching the count sheet holder to the container using a strap.