Single-use disposable sterile kit

A single use disposable surgical kit, including a sterile sealed container including a module configured to fit within the sterile sealed container including surgical instruments housed in a bottom tray including a first fastening feature; and a lid including a second fastening feature congruently aligned with the first fastening feature, wherein the first fastening feature is one of a tab portion and a mating slot, the second fastening feature is the other of the tab portion and the mating slot, and the second fastening feature is configured to engage with the first fastening feature.

TECHNICAL FIELD

Various exemplary embodiments disclosed herein relate generally to a single-use disposable sterile kit.

BACKGROUND

Conventional surgical kits are typically provided by manufacturers in non-sterile, reusable instrument sets that are too cost-prohibitive for use in smaller healthcare facilities, such as Ambulatory Surgical Centers. Such kits are also problematic for high-volume periods of usage in hospitals due to the need for reprocessing steps which are time and cost dependent.

Disposable orthopedic surgical kits are generally sold as sterile kits that contain bone plate(s) and a plurality of fasteners as well as housings for the fasteners. The kits also may contain wires, drill bits, drill guides, depth gauges and screwdrivers. Disposable kits help provide streamlined, cost-effective instrument sets to a wider range of healthcare facilities.

SUMMARY

This disclosure relates generally to a single-use disposable sterile kit. An example of such a sterile kit is a single-use disposable orthopedic surgical sterile kit that allows for the implantation of bone plates for the fixation of bone fractures. The single-use disposable orthopedic surgical sterile kit will be used as an example sterile kit, but sterile kits for other applications may be carried out according to the disclosure below.

Various embodiments relate to a single-use disposable sterile kit, including a sterile sealed container, a first module including a single bone plate having a plurality of fastener apertures, a fastener housing including a plurality of protrusions, stairs and concave depressions for housing a plurality of fasteners; and a second module including instruments required to fixate a bone fracture. In various embodiments, the first and second modules sit within two separate cutout sections of the sterile sealed container.

Various additional embodiments relate to a single use disposable orthopedic surgical kit including a sterile-sealed container including a first module configured to fit within the sterile sealed container including: a single bone plate including a plurality of fastener apertures and a fastener housing including a plurality of protrusions on the top of the fastener housing, a plurality of stairs extending downward from the top of the fastener housing, and a plurality of concave depressions located on the top surface of the plurality of stairs for housing a plurality of fasteners, each of the plurality of fasteners including a head and a shaft.

Various additional embodiments relate to a single use disposable orthopedic surgical kit including a first module including: a single bone plate including a plurality of fastener apertures and a fastener housing including a plurality of protrusions on the top of the fastener housing, a plurality of stairs extending downward from the top of the fastener housing and a plurality of concave depressions located on the top surface of the plurality of stairs for housing a plurality of fasteners, each of the plurality of fasteners including a head and a shaft. The kit further includes a second module including instruments used to fixate a bone fracture.

Various additional embodiments relate to a single use disposable orthopedic surgical kit including a first module including a single bone plate including a plurality of fastener apertures and a fastener housing including a plurality of protrusions on the top of the fastener housing, a plurality of stairs extending downward from the top of the fastener housing and a plurality of concave depressions located on the top surface of the plurality of stairs for housing a plurality of fasteners, each of the plurality of fasteners including a head and a shaft. In various embodiments of the kit, the plurality of protrusions extend upward and away from the top of the fastener housing and the plurality of concave depressions are integrally formed on the top surface of the plurality of stairs. The kit additionally includes a second module including instruments used to fixate a bone fracture.

Various embodiments relate to a first module including a first well and a second well. In various embodiments, the fastener housing is included in the first well and the bone plate included in the second well.

Various embodiments are described wherein the first module includes a one-shot injection-molded fastener housing having a plurality of protrusions extending upward from the top of the fastener housing and having a plurality of stairs and a plurality of concave depressions included within a first and second cavity of the fastener housing to prevent the fasteners from threading into the fastener housing. In various embodiments, the plurality of concave depressions are integrally formed with the top surface of the stairs. In various embodiments, the plurality of protrusions, plurality of stairs and plurality of concave depressions work together to prevent fastener angulation or jamming during transit and handling.

In various embodiments of the first module, the plurality of fasteners is arranged in the fastener housing in a plurality of groupings of the fasteners. The first one of the plurality of groupings includes only fasteners having a first shaft length and the second one of the plurality of groupings includes only fasteners having a second shaft length that is different from the first shaft length. The fasteners in the first one of the plurality of groupings are segregated from the fasteners in the second one of the plurality of groupings. In various embodiments, the fastener housing may include a first fastener receptacle to house the first one of the plurality of groupings of fasteners and a second fastener receptacle to house the second one of the plurality of groupings of fasteners. In various embodiments, the fasteners sit within the fastener housing in a staggered configuration. The heads of the fasteners are dimensioned to mate with the fastener apertures in the bone plate. In one embodiment, the head and shaft of the fasteners both include threads.

In various embodiments of the first module, the lengths of the fasteners are based on the included bone plate and anatomic study. The fasteners may include a first sized head or a second sized head. All of the fastener apertures of the bone plate may be dimensioned to receive either the first sized head or the second sized head. The kit may include forty-four or fewer fasteners, each of which may have one of seven different shaft lengths. The fasteners may be arranged in the fastener housing in a plurality of groupings of four or fewer fasteners, each having the same shaft length.

Various embodiments are described wherein the fastener housing may include labels to indicate the shaft length of each of the plurality of groupings of fasteners. The fastener housing may include a fastener length gauge to aid the user in determining the length of each of the plurality of fasteners.

Various embodiments of the first module are described wherein the bone plate, fasteners and fastener housing are housed in a double-sterile barrier to ensure sterility.

Various further embodiments relate to a single use disposable surgical kit including a sterile sealed container including: a first module configured to fit within the sterile sealed container including a single bone plate including a plurality of fastener apertures and a fastener housing; and a second module configured to fit within the sterile sealed container including instruments used to fixate a bone fracture housed in a bottom tray including a first fastening feature and a lid including a second fastening feature congruently aligned with the first fastening feature wherein the first fastening feature is one of a tab portion and a mating slot, the second fastening feature is the other of the tab portion and the mating slot and the second fastening feature is configured to engage with the first fastening feature.

Various further embodiments relate to a single use disposable surgical kit including a sterile sealed container including a module configured to fit within the sterile sealed container including surgical instruments housed in a bottom tray including a first fastening feature, and a lid including a second fastening feature congruently aligned with the first fastening feature wherein the first fastening feature is one of a tab portion and a mating slot, the second fastening feature is the other of the tab portion and the mating slot and the second fastening feature is configured to engage with the first fastening feature.

Various additional embodiments are described wherein the second module includes instruments required to fixate a bone fracture. In various embodiments, the module includes a disposable torque limiting screwdriver adapted to engage the fastener heads and further includes a torque limiting stop. The module may additionally include a depth gauge, K-wires, a drill bit and a drill guide.

In various embodiments of the module, the instruments are presented in approximate order of clinical use in a bottom tray. In various embodiments, the bottom tray includes a plurality of cutout areas to house the instruments. In various embodiments, the bottom tray additionally includes a plurality of partitions that allow for the surgical instruments to sit up above the floor of the bottom tray for easier removal during use. The handle and pick-up area of the instruments may be oriented towards the user.

In various embodiments of the module, the bottom tray may include locking tabs diagonally aligned on at least two corners of the tray. In various embodiments, the locking tabs include ridges to facilitate gripping of the tab.

In various embodiments of the module, the bottom tray is covered by a lid, which includes a plurality of cutout areas to enclose the instruments. In various embodiments, the lid may include mating slots present in at least two corners of the lid. Such mating slots may be congruently aligned with the locking tabs included on the tray. In various embodiments, the mating slots may include arm extensions that enclose the locking tab to lock the bottom tray and lid together.

In various embodiments, the first module and the second module may be removable from the sterile sealed container. The sterile sealed container may include cutouts to aid with removal of the first and second modules.

Various embodiments of the kit are described wherein the instruments may be packaged separately from the bone plates, fasteners and fastener housing so that the instrument tray may also be used for an instrument-only sterile kit.

In various embodiments, the sterile container, the first module and the second module, may all be made of a thermoformed plastic material. In various embodiments, the sterile container, the first module and the second module may all be formed from a transparent polymer.

DETAILED DESCRIPTION

Below embodiments of a disposable single-use sterile kit are described. The kit generally includes a sterile sealed container with cutout portions to house a first and second module. The first module includes a fastener housing and a bone plate and the second module includes instruments required for fixing a bone fracture. The first and second modules are described in more detail in the figures below.

FIG. 1illustrates an embodiment of the sterile kit in an open configuration including a sterile tray100with cutout portions to house a first module110and a second module120. The sterile tray100, first module110and second module120are thermoformed from any one of a number of polymers, for example polyethylene terephthalate glycol-modified. Sterile tray100can have a rectangular shape defined by four tray sides101-104, although other shapes may be desirable depending on functional, economic, aesthetic or other reasons. Sterile tray100includes a tray bottom105. Sterile tray100is compartmentalized by several, integrally formed partitions106that may extend from the inside of tray bottom105and/or the inside of tray sides102,104to form cutouts107,108where the integrally formed partitions separate the first and second modules from each other. The first module110includes wells111,112to house a fastener housing130and a bone plate140. The first module110additionally includes a plastic covering113that lies on top of the fastener housing130and the bone plate140.

In the embodiment ofFIG. 1, the second module120includes a drill bit121, K-wires122, a depth gauge123, a variable angle drill guide124, a coaxial drill guide125, a torque limiting screwdriver126and a torque limiting stop127.

FIG. 2Aillustrates a top perspective view of an embodiment of the second module220. The second module includes a bottom tray250and a lid260positioned to sit on top of the bottom tray250. The bottom tray250and lid260are locked together using locking tabs251positioned diagonally opposite of each other in the upper left-hand corner and lower right-hand corner of the tray250as shown. Either one or both of the bottom tray250and lid260may be formed from a transparent polymer to allow viewing of the components included therein without opening the second module220.

FIGS. 2B and 2Cillustrate a more detailed view of an embodiment of the locking tabs251. The locking tabs251positioned diagonally opposite each other in two corners of the bottom tray250lock into mating slots261congruently positioned on the lid260to receive the locking tabs251.

FIG. 3illustrates a top perspective view of an embodiment of the bottom tray350. The bottom tray350can have a generally rectangular shape defined by four tray sides352-355, although other shapes may be desirable depending on functional, economic, aesthetic or other reasons. Bottom tray350is compartmentalized by partitions356that form cutout areas357in which the instruments required for fixing a bone fracture121-127are placed. The partitions356are positioned to allow for the instruments121-127to sit up above the floor of the bottom tray350. The bottom tray350includes locking tabs351diagonally positioned in the upper left-hand corner and lower right-hand corner.

FIG. 3Aillustrates a more detailed view of an embodiment of the locking tab351. The locking tab includes a tab portion351awhich is connected to the bottom tray350by way of a connecting piece351bthat is narrower than the tab portion351a. The tab portion351aalso includes ridges351cto facilitate gripping of the locking tab351.

FIG. 4illustrates a bottom perspective view of an embodiment of the lid460. The lid460can have a generally rectangular shape defined by four sides462-465, although other shapes may be desirable depending on functional, economic, aesthetic or other reasons. Lid460is compartmentalized by partitions466that form cutout areas467that fit over the instruments required for fixing a bone fracture121-127. The lid cutout areas467fit together with the bottom tray cutout areas357to enclose the individual instruments. The lid460includes mating slots461in which the locking tabs351are inserted to lock the bottom tray350and lid460together.

FIG. 4Aillustrates a more detailed view of the mating slot461which includes arm extensions461athat enclose the connecting piece351band lock the tab portion351aof the bottom tray350within the mating slot461of the lid460.

FIG. 5illustrates a top perspective view of an embodiment of the first module510. The first module may be in the form of a tray511having a generally rectangular shape, although other shapes may be desirable depending on functional, economic, aesthetic or other reasons. The tray511includes a first well512and a second well513. The first well512includes a fastener housing530and the second well513includes a bone plate540.

FIG. 6illustrates a top perspective view of the fastener housing630. The fastener housing630includes a fastener length gauge631configured and labeled by a size label631afor measuring incremental lengths of a plurality of fasteners. The incremental lengths may range, for example, between 10 mm and 30 mm by 2 mm increments. As illustrated in more detail inFIG. 6C, the fastener length gauge631has a channel631band a seat631c. Using fastener length gauge631, the surgeon may quickly confirm the length of a selected fastener prior to implantation of the fastener into the patient, and ensure that the fastener is of sufficient length to properly engage bone, but not so long as to protrude too far from the bone and into soft tissue.

FIGS. 6 and 6Aillustrate a perspective and top view of the fastener housing630wherein the fastener housing630includes a plurality of first fastener receptacles632to house a first plurality of fasteners and a plurality of second fastener receptacles633to house a second plurality of fasteners. Each of the first and second receptacles632,633is sized and shaped to loosely retain a first plurality of fasteners and a second plurality of fasteners, respectively.

The fastener housing630may be prepared using injection-molding to form a first cavity634extending from the left sidewall639ato a molded dividing wall639b, which is located directly underneath the plurality of first fastener receptacles632. The fastener housing630may further include a second cavity635separated from the first cavity by the molded dividing wall639b, which is located directly underneath the plurality of second fastener receptacles633. The first cavity634and second cavity635are surrounded by the molded walls of the fastener housing630on three sides with the fourth side open so that the shafts of the fasteners are visible.

As illustrated inFIGS. 6B and 6D, the fastener housing630additionally includes a plurality of protrusions637that extend upwards and away from the top of the fastener housing630. The first cavity634and the second cavity635each include a plurality of stairs636that extend downward from the top of the fastener housing, and a plurality of concave depressions638that sit on the top surface of the stairs636. In one embodiment, the heads of the fasteners sit atop the plurality of protrusions637while a small portion of the shaft of the fasteners sit within the plurality of concave depressions638. The stairs636cause the fasteners to sit within the fastener housing630in a staggered configuration. The plurality of protrusions637, plurality of stairs636and plurality of concave depressions638act in combination to prevent fastener angulation or jamming during transit and handling.

The first plurality of fasteners may be arranged in the first fastener receptacle632in a plurality of groupings of 7 or fewer fasteners and the second plurality of fasteners may be arranged in the second fastener receptacle633in a plurality of groupings of 4 or fewer fasteners. Each grouping corresponds to a particular one of a number of distinct fastener lengths. As shown inFIG. 6, receptacles632and receptacles633are arranged in groupings, such that each grouping may include up to 4 fasteners of the same shaft length.

When the kit is opened, the user may easily grasp the exposed end of each fastener and remove it from fastener housing630. Alternately, the user may pick each fastener from the fastener housing630using a suitable drive instrument. Since each single-use kit may include only the number of fasteners required for the particular surgical indication, with a few extra, a number of first fastener receptacles632and second fastener receptacles633may be empty.

FIGS. 7 and 7Aillustrate the cutout portions included in sterile tray700in which the first module710and second module720are housed.

It should be appreciated by those skilled in the art that any diagrams or schematic drawings herein represent conceptual views of illustrative structures embodying the principles of the invention.