Patent Description:
Human handling of such instruments prior to sterilization is labor intensive and error prone. It remains desirable to have systems and methods for automating this process.

<CIT> discloses systems and methods for packaging of mass-fabricated custom items. An automated robotic system for cleaning and packaging surgical instruments is known from <CIT>.

The present invention is directed to systems and methods for identifying and packaging instruments and logging production data. A system and a method according to the invention are defined by the independent claims. Preferred embodiments are given by the dependent claims.

In one embodiment, the packager is a unit that holds a roll of packaging tubing and cuts and forms a package in response to instructions received from the instrument processor.

The instrument transfer device in a first embodiment is a catch and release mechanism. The instrument transfer device in a second embodiment is a robotic arm. In both these embodiments, the transfer device moves an instrument from a receiving element such as a conveyor or an instrument identification platform and transfers the instrument to a packaging element such as a peel pouch.

The present invention together with the above and other advantages may best be understood from the following detailed description of embodiments illustrated in the drawings, wherein:.

Embodiments of the present invention enable automated processing and packaging and logging of instrument data for a plurality of surgical instruments.

A system for automating peel pouch production follows the flow chart in <FIG>. At step <NUM>, an instrument type is determined. When an instrument enters into the system for processing, the instrument may be labeled or unlabeled. Determining the instrument type may involve reading a label or analyzing the instrument. This is described in greater detail below.

At step <NUM>, the data specific to the creation of the peel pouch is determined based on the instrument type. The peel pouch data may include, but is not limited to, the information for the peel pouch label, and the pouch type and size. At step <NUM>, the peel pouch is created, or made. Peel pouch creation includes the steps of producing an appropriately-sized pouch, affixing a label to the pouch, placing one or more instruments inside the pouch, and sealing the pouch.

<FIG> is a block diagram of an automated instrument packaging system <NUM>. The instrument packaging system <NUM> includes an instrument processor <NUM> having an input <NUM> and an output <NUM>, an instrument analyzer <NUM> and an instrument database <NUM>. An instrument identification platform <NUM>, a labeler <NUM>, a packager <NUM> and a transfer device <NUM> are all in communication with the instrument processor <NUM>.

The instrument identification platform <NUM> includes one or more instrument identifying devices. The instrument identifying platform <NUM> automates the process of determining instrument type. One embodiment employs a machine vision system to recognize the instrument type. Another embodiment employs a bar code reader. Yet another embodiment employs an RFID scanner. Other means of recognizing a particular instrument are possible within the scope of the invention. The instrument identification platform submits the instrument identification data to the instrument processor <NUM> through the input <NUM>.

The instrument analyzer <NUM> receives the instrument identification data provided by the instrument identification platform <NUM>. If the instrument identification platform was not able to specifically identify the instrument type, the instrument analyzer <NUM> accesses data stored in the instrument database <NUM> to identify the particular instrument by comparing the received data with stored data. The instrument analyzer <NUM> also determines instrument packaging data based on the instrument type and information stored in the instrument database <NUM>.

In one embodiment, the instrument analyzer <NUM> includes a peel pouch data device. The peel pouch data device receives instrument type information from the instrument identification platform <NUM> or another source. Using the instrument type, the peel pouch data device may access stored information in the database <NUM> regarding peel pouch data that pertains to the identified instrument type.

Additional embodiments of the system employ an output device <NUM>. The output device <NUM> provides data from the peel pouch data device and automates the creation of a peel pouch. One embodiment uses a computer monitor for quickly displaying the peel pouch data and providing instruction to an operator for producing the peel pouch. In an alternative embodiment, the output device is in communication with a labeler <NUM>, for example a printer that produces the label to be affixed to the peel pouch. Additional embodiments include a packager <NUM>, that is, a device for automatically producing a pouch of the required size. The packager <NUM> may make the pouch from a roll of tubing, or may select a pre-made pouch. In an alternative embodiment of the packager <NUM>, the packager has a selection of pre-made pouches that the packager presents to receive one or more instruments.

In another alternative embodiment, the packager <NUM> selects a desired amount of packaging material, places the one or more instruments in the selected packaging material, closes and seals the packaging material, prints the label with the selected information and places the label on the package or pouch and sends the instrument data to a log. The log may reside in the packager <NUM> or alternatively in the instrument database <NUM>. Other locations are possible within the scope of the invention.

The system <NUM> can include a transfer device <NUM>. In one embodiment, the transfer device <NUM> is a conveyor to move the one or more instruments both before and after packaging. The transfer device <NUM> may also include a robotic arm or similar mechanical device to handle the one or more instruments and place them in the selected packaging. In another embodiment, the transfer device <NUM> may also transfer the package or pouch to a sterilization device.

In one alternative embodiment of the system <NUM>, the labeler <NUM> prints information directly on the packaging. Alternatively, the label can be affixed to the packaging manually or by an external applicator. In still other embodiments, a sterility indicator may be placed in the selected packaging with the one or more instruments. In other embodiments, the packaging material can be heat sealed after the one or more instruments are placed in it, or it can be sealed by an external means. In still another embodiment, the one or more instruments can be placed in the selected packaging by external means, such as a user, and the system then notified that the packaging is ready to be sealed.

Additionally, the system can be configured to identify and package medical items other than instruments, such as, for example, implantable items and tubing connections. <FIG> is a flow chart for the operation of an automated system for the identification, package selection, and packaging of instruments for sterilization such as that shown in the block diagram of <FIG>. At step <NUM>, the system provides that an instrument is selected. At step <NUM>, the instrument is placed on an instrument identification platform which in one embodiment includes a conveyor. One skilled in the art will recognize that the system may be used for packaging of other components and materials in medical and nonmedical applications.

As shown in <FIG>, at step <NUM>, the system employs a device to recognize the instrument using, for example, machine vision, barcodes, RFIDs, or other indicia. The recognition device may be incorporated into the system or may be external. If the system recognizes the instrument, the system proceeds to step <NUM>. If the system does not recognize the instrument, the system proceeds to step <NUM>.

At step <NUM>, information about the instrument is compared with a database of known instruments. When the instrument is identified using this comparison, the system proceeds to step <NUM>.

At step <NUM>, the desired packaging is determined and then selected or created based on instrument identification. In a first example (not within the scope of the claims), the desired packaging is selected from an inventory of various sizes of packaging. In an embodiment of the invention, customized packaging or pouches are cut from bulk packaging material utilizing information from the database of known instruments. The bulk packaging could consist of tubing material.

At step <NUM>, a label is printed on the packaging or alternatively, it is printed on a label which is then applied to the packaging.

At step <NUM>, with continued reference to <FIG>, the instrument is placed in the desired packaging using mechanical or automated means, including for example, a robotic arm.

At step <NUM>, the packaging is then sealed and the instrument is ready for sterilization.

At step <NUM>, the instrument is then placed in a storage area.

<FIG> is a flow chart for the operation of another embodiment of an automated system for the identification, package selection, and packaging of instruments for sterilization. At step <NUM>, the system provides that an instrument is selected. At step <NUM>, the instrument is placed on a conveyor and an operator initiates the process. One skilled in the art will recognize that the system may be used for packaging of other components and materials in medical and nonmedical applications.

At step <NUM>, the system employs a device to recognize the instrument using, for example, machine vision, barcodes, RFIDs, or other indicia. The recognition device may be incorporated into the system or may be external.

At step <NUM>, the data related to creating a peel pouch from the identified instrument is retrieved. The data may be stored in a relational database and retrieved by using the instrument type.

At step <NUM>, the desired packaging is created or retrieved. In a first example (not within the scope of the claims), the desired packaging is selected from an inventory of various sizes of packaging. In an embodiment of the invention, customized packaging or pouches are cut from bulk packaging material utilizing information from the database of known instruments. The bulk packaging could consist of tubing material.

At step <NUM>, a label is printed on the packaging or alternatively, it is printed on a label which is then applied by an operator to the packaging.

At step <NUM>, the operator places the instrument in the pouch and seals it using a heat sealer or equivalent.

<FIG> illustrates elements of a system for automated instrument sterilization according to one embodiment. The system includes a conveyor <NUM> for instrument conveyance. A catch release mechanism <NUM> is attached to the conveyor for catching the conveyed instrument. A looped instrument chute <NUM> is attached to the catch release mechanism and feeds the instrument to a packaging turret <NUM>. The system further includes a label printer <NUM>.

In operation, an instrument to be sterilized is placed on the conveyor. The camera is positioned in relation to the conveyor so that the instrument is in the camera's field of view.

The system receives data about the instrument through the camera. In alternative embodiments, other sensors may be used to take instrument data. After data about the instrument is taken, the instrument is conveyed into the catch release mechanism and from there into is sent into the looped instrument chute. The instrument is received from the instrument chute at a packaging turret.

The packaging turret has a plurality of pouches ready to receive instruments. The turret receives the instrument into a pouch selected by the sterilization system. In a first embodiment, the pouches are different sizes and the sterilization system selects a pouch of an appropriate size for the instrument. In an alternative embodiment, the looped instrument chute is positioned over a selected pouch. In a further alternative embodiment, the turret moves under the instrument chute and the sterilization system directs the turret to position an appropriate pouch for the instrument under the chute.

The pouch with an instrument is then processed by the system as described above with regard to <FIG>. The label printer prints labels. The pouches are labeled and processed in a sterilization unit and then placed into storage.

The automated system described above enables instruments to be identified, packaged and sterilized without human handling. The automated system provides the benefits of increased safety in the contaminated instruments are not handled by people who could become infected and also that the instruments themselves will not become contaminated from handling by people. Further, the system enables accurate sorting and labeling and efficient packaging.

Claim 1:
A system (<NUM>) for packaging medical instruments for sterilization, comprising:
an input (<NUM>) for receiving instrument identification data;
an instrument processor (<NUM>) coupled to the input (<NUM>), the instrument processor (<NUM>) including a database (<NUM>) and an instrument analyzer (<NUM>),
wherein the database (<NUM>) is configured to store instrument type data, instrument packaging data and package labeling data,
wherein the instrument analyzer (<NUM>) is configured to identify an individual instrument based on the received instrument identification data and to determine the individual instrument packaging type based on the identified instrument, and to determine a labeling associated with the identified instrument using data stored in the database (<NUM>),
wherein the instrument analyzer (<NUM>) is further configured to determine instrument handling instructions, packaging instructions, and labeling instructions based on the determined instrument packaging type; and
an output (<NUM>) coupled to the instrument processor (<NUM>), wherein the output (<NUM>) is configured for sending the handling instructions, packaging instructions, and labeling instructions to at least one external device, whereby
the at least one external device includes a packager (<NUM>) configured to, for each individually identified instrument, automatically customize a variably sized package cut from bulk packaging material based on the received instrument identification data for the identified instrument, in response to packaging instructions received from the instrument processor, such that a plurality of variably sized packages are automatically produced.