WO2023203400A1

WO2023203400A1 - Visual recognition tool for package inspection

Info

Publication number: WO2023203400A1
Application number: PCT/IB2023/052648
Authority: WO
Inventors: Javier Gonzalez; Nikita Prabhu; Jonathan G. REHBEIN
Original assignee: 3M Innovative Properties Company
Priority date: 2022-04-19
Filing date: 2023-03-17
Publication date: 2023-10-26

Abstract

Methods and systems for determining if a package contains a sterile breach. A method of inspecting a packaging can include providing the package for inspection, providing a device having inspection capabilities, selecting a package inspection program on the device, identifying a package type, in the package inspection program, corresponding to the package, loading comparative breach data corresponding to the package type, scanning the package with the device to create a package image, comparing the package image to the comparative breach data to identify possible breach locations, reexamining, with the device, the possible breach locations, and determining whether to reject or accept the package.

Description

VISUAL RECOGNITION TOOL FOR PACKAGE INSPECTION

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63/332,582, filed on April 19, 2022, which is incorporated herein by reference in its entirety.

TECHNICAL FIELD

[0002] The invention set forth in the appended claims relates generally to package inspection systems and more particularly, but without limitation, to systems and methods of inspecting packages to detect any sterile breaches.

BACKGROUND

[0003] Dressings or kits to be used at a tissue site are packaged in sterile packaging prior to use. The use of sterile packaging ensures that the dressing or kit remains sterile prior to being used at a tissue site which reduces the potential for harm to the patient including reducing the risk of infection. To ensure that only sterile dressings and kits are being used at tissue sites, regulations have been put in place to require inspection of sterile packaging immediately prior to aseptic presentation.

[0004] To comply with these regulations, it is standard for physicians or other health care providers to visually inspect sterile packaging prior to opening the packaging and deploying the dressing or kit at a tissue site. Large breaches may be easily detectible with a visual inspection, but some sterile breaches may be pinhole size or smaller and may be difficult or impossible to see with the naked eye. A system designed to detect sterile breaches in packaging containing dressings and kits to be used at tissues sites may benefit healthcare providers and patients.

BRIEF SUMMARY

[0005] New and useful systems, apparatuses, and methods for inspecting sterile packaging are set forth in the appended claims. Illustrative embodiments are also provided to enable a person skilled in the art to make and use the claimed subject matter.

[0006] For example, in some embodiments, a method of inspecting sterile packaging is described. The method can include providing a package for inspection, providing a device having inspection capabilities, selecting a package inspection program on the device, identifying a package type, in the package inspection program, corresponding to the package, loading comparative breach data corresponding to the package type, scanning the package with the device to create a package image, comparing the package image to the comparative breach data to identify possible breach locations, reexamining, with the device, the possible breach locations, and determining whether to reject or accept the package.

[0007] In some example embodiments, the device can include a smart phone. [0008] In some example embodiments, scanning the package with the device can include scanning the package with a LIDAR scanner. In other example embodiments, scanning the package with the device can include scanning the package with an orientation and distance-correcting scanner.

[0009] In some example embodiments, reexamining, with the device, the possible breach locations includes scanning, with the device, each possible breach location from more than one angle and evaluating, with the device, whether each possible breach location is a breach location.

[0010] In some example embodiments, the method can further include visually inspecting each possible breach location. Additionally, in some example embodiments, the method can further include reporting data associated with scanning the package with the device and reexamining, with the device, the possible breach locations to a reporting destination.

[0011] In some example embodiments, if the package is rejected, an option to order additional packages can be outputted on the device.

[0012] In some example embodiments, the package can include packaging with reflective material. Scanning the package with the device can include using the reflective material to identify the possible breach locations.

[0013] Also described herein is a system for inspecting sterile packaging. In some example embodiments, the system can include at least one processor and at least one memory and a device for scanning a sterile package. The at least one memory can be configured to, with the at least one processor, cause the system to perform, in response to receiving a package input, loading comparative breach data corresponding to the package input. The memory can further cause the system to perform scanning the sterile package with the device to create a package image, comparing the package image to the comparative breach data to identify damaged locations of the sterile package, and causing the device to display an option to accept or reject the sterile package.

[0014] In some example embodiments, if a damaged location is identified, the memory can cause the system to further perform reexamining the damaged location. In some example embodiments, reexamining the damaged location can include scanning the damaged location from more than one angle.

[0015] In some example embodiments, the package input is a user input identifying the package to be scanned. In some example embodiments, the device can include a smart phone with LIDAR scanning capabilities or other orientation and distance-correcting capabilities. In some example embodiments, the comparative breach data is historical data of damaged packages. In some example embodiments the damaged locations are pinholes in the package. In other example embodiments, the damaged locations are broken seals on the package.

[0016] In some example embodiments, the memory can cause the system to further perform sending, to a cloud location, data associated with the package image. [0017] In some example embodiments, the memory can cause the system to further perform causing the device to display an option to order additional packages to replace the package if the package is declined.

[0018] Objectives, advantages, and a preferred mode of making and using the claimed subject matter may be understood best by reference to the accompanying drawings in conjunction with the following detailed description of illustrative embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure l is a block diagram of an example method of examining a package to determine if it contains a sterile breach;

[0020] Figure 2A is a perspective view of a package containing a sterile breach;

[0021] Figure 2B is a detail view of the sterile breach of the package of Figure 2A;

[0022] Figure 3 is a perspective view of a smart phone displaying a package inspection program;

[0023] Figure 4 is a perspective view of the smart phone of Figure 3 scanning a package to generate a package image;

[0024] Figure 5A is a perspective view of the smart phone of Figure 3 displaying the package image generated from scanning the package;

[0025] Figure 5B is a perspective view of the smart phone of Figure 3 displaying a detail view of identified possible breach locations;

[0026] Figure 6 is a perspective view of the smart phone of Figure 3 scanning a possible breach location of the package;

[0027] Figure 7 is a perspective view of the smart phone of Figure 3 displaying a decision for a user to make to reject or accept the package;

[0028] Figure 8 is a perspective view of the smart phone of Figure 3 displaying options to report data, order more packages, and contact a company for help;

[0029] Figure 9A is a perspective view of an assembly line used to manufacture sterile packages; and

[0030] Figure 9B is a perspective view of another assembly line used to manufacture sterile packages scanning a package.

DESCRIPTION OF EXAMPLE EMBODIMENTS

[0031] The following description of example embodiments provides information that enables a person skilled in the art to make and use the subject matter set forth in the appended claims, but it may omit certain details already well-known in the art. The following detailed description is, therefore, to be taken as illustrative and not limiting.

[0032] The example embodiments may also be described herein with reference to spatial relationships between various elements or to the spatial orientation of various elements depicted in the attached drawings. In general, such relationships or orientation assume a frame of reference consistent with or relative to a patient in a position to receive treatment. However, as should be recognized by those skilled in the art, this frame of reference is merely a descriptive expedient rather than a strict prescription.

[0033] Referring to Figure 1, a method 100 of determining if a package contains a sterile breach is shown. The method 100 can start at step 102 and proceed to step 104 where a package is received. In some embodiments, the package may contain a dressing or a kit for deploying at a tissue site. In other embodiments, the package may house other contents that must be kept sterile prior to opening the package.

[0034] After a package is received at the step 104, the method 100 may proceed to step 106 where a package inspection program is opened on a tool. In some embodiments, the tool may be a smart phone and the package inspection program may be an application stored on the smart phone. The smart phone may be a handheld electronic device that provides a connection to a cellular network and the Internet. In other embodiments, the tool may be any device that is capable of performing the method 100.

[0035] The method 100 may proceed to step 108 after the package inspection program is opened at the step 106. The step 108 may include identifying a package type, of the received package, in the package inspection program. In some embodiments, identifying the package type of the received package can include selecting the package type from a list of options displayed on a user interface of the tool. The package type may identify the package that is received in the step 104. For example, if the package contains a dressing of type A, a user may select the package type that corresponds to a dressing of type A at the step 108.

[0036] Once the package type is selected at the step 108, the method 100 may proceed to step 110 where a breach data set is loaded. The breach data set may correspond to the identified package type from the step 108. For example, if the package type is a dressing of type A, the breach data set may correspond to dressings of type A. The breach data set can include historical data corresponding to the identified package type. The historical data can include images and data of sterile breaches on packaging of the identified package type.

[0037] The method 100 may proceed to step 112 where the tool may be used to scan the received package. When the received package is scanned with the tool, the tool may create a package image based on the scan of the received package. In some embodiments, the received package may be scanned with a LIDAR scanner of the tool. In other embodiments, the received package may be scanned with another orientation and distance-correcting technology.

[0038] The method 100 may proceed to step 114 after the package image is created in the step 112. At the step 114, the package image may be compared to the breach data set. In some embodiments, comparing the package image to the breach data set can include analyzing the package image to determine whether the package contains any possible breaches that may be identified in the breach data set. After comparing the package image to the breach data set, the method 100 may proceed to conditional step 116 where the method 100 determines if a possible breach is identified. In some embodiments, a possible breach may be identified if the package image has a characteristic or data that is similar to or equivalent to a characteristic or data that is stored in the breach data set. The method 100 may determine that the package does not contain a possible breach if the package image does not have a characteristic or data that is similar to or equivalent to a characteristic or data that is stored in the breach data set.

[0039] If the method 100 identifies a possible breach at the conditional step 116, the method 100 may proceed to step 118 where each possible breach is re-scanned with the tool to create a possible breach image. The step 118 may be similar to the step 112 and each possible breach may be scanned with a LIDAR scanner of the tool. In other embodiments, the received package may be scanned with another tool with orientation and distance-correcting scanning capabilities. In contrast to the step 112, in the step 118, the scanning may be directed to or focused on each possible breach location. In some embodiments, each possible breach location may be scanned from more than one angle to create each possible breach image.

[0040] After each possible breach image is created at the step 118, the method 100 may proceed to step 120 where each possible breach image is compared to the breach data set. The step 120 may be similar to the step 114 such that comparing each possible breach image to the breach data set can include analyzing the possible breach image to determine whether any of the possible breach locations of the package are similar to or equivalent to breaches identified in the breach data set. After comparing each possible breach image to the breach data set, the method 100 may proceed to conditional step 122 where the method 100 determines if any possible breach is a true breach. In some embodiments, a possible breach may be identified as a true breach if the possible breach image has a characteristic or data that is similar to or equivalent to a characteristic or data that is stored in the breach data set. The method 100 may determine that the possible breach is not a true breach if the possible breach image does not have a characteristic or data that is similar to or equivalent to a characteristic or data that is stored in the breach data set.

[0041] If the method 100 identifies determines that any of the possible breaches are true breaches at the conditional step 122, the method 100 may proceed to step 124 where the package is rejected. In some embodiments, the step 124 may include displaying a message on a user interface of the tool and may require a user to confirm that the package should be rejected. In other embodiments, the step 124 may not require a user to confirm that the package should be rejected and may simply display a message that the package contains a sterile breach, and the contents of the package should not be used. In other embodiments, the step 124 may allow a user to override the rejection if, for example, the user is able to visually inspect the package to determine that any possible breaches are not true breaches.

[0042] If the method 100 determines that there are no possible breaches identified in the conditional step 116 or that none of the possible breaches are true breaches in the conditional step 122, the method 100 may proceed to step 126 where the package is accepted. In some embodiments, the step 126 may include displaying a message on the user interface of the tool indicating that no sterile breaches have been identified on the package.

[0043] The method 100 may further include step 128 where data from the method 100 is reported. The step 128 may follow both the step 126 where the package is accepted and the step 124 where the package is rejected. In some embodiments, the data may include the package image and each possible breach image. In other embodiments, the data may include additional information collected or determined while using the package inspection program on the tool. In some embodiments, the user interface of the tool may display an option to the user to determine whether they want to report the data. In other embodiments, the data may be automatically reported once the package is accepted or rejected. In some embodiments, reporting the data may include sending the data directly to a manufacturer of the packaging. In other embodiments, reporting the data may include uploading the data to a cloud location. In some embodiments, reporting the data may further include incorporating the data into the breach data set for the package type of the package. Incorporating the data into the breach data set for the package type of the package may add additional data that can be compared to a package image of a future package to be scanned by the tool. The method 100 may conclude with step 130 after the data is reported in the step 128.

[0044] Figures 2A-8 depict a method or a system for determining if a package contains damaged locations or sterile breaches immediately prior to opening the package for use on a tissue site. Referring to Figures 2A-2B, a package 200 is shown. The package 200 may have a first surface 202 and a second surface 204 opposite the first surface 202. The package 200 may contain a dressing 206 disposed between the first surface 202 and the second surface 204. In some embodiments, the package 200 may also include additional contents 208. In some embodiments, the additional contents 208 may be instructions for deploying the dressing 206 at a tissue site or additional components of the dressing 206. In some embodiments, the first surface 202 may be transparent such that the contents of the package 200 can be seen through the first surface 202. The first surface 202 may be coupled to the second surface 204 along a periphery 210 of the package 200. In some embodiments, the periphery 210 may further include reflective material 212. The reflective material 212 may enhance the ability of a tool to detect or identify any possible sterile breaches of the package 200. In other embodiments, the reflective material 212 can be disposed in a different location on either the first surface 202 or the second surface 204 of the package 200.

[0045] The package 200 may further include a pinhole 214 through the first surface 202 of the package 200. In some embodiments, the pinhole 214 may be too small to detect with the human eye. While some sterile breaches may be obvious to the naked eye, any breach in a sterile package can increase the risk of harm to a patient or a user. It is important that the pinhole 214 or other sterile breaches be identified prior to any contents of the package being used to reduce the risk of infection and potential for harm to a patient or user. [0046] Referring to Figure 3, a user 300 is shown holding a device or a tool 302. In some embodiments, the tool 302 may be a smart phone. In other embodiments, the tool 302 may be a different piece of equipment that may be configured to interact with the user 300. The tool 302 may include a user interface 304. In some embodiments, the user interface 304 may be a touch screen that the user 300 can interact with. In other embodiments, the user interface 304 may not be a touch screen but may still be configured to enable the user 300 to interact with the tool 302.

[0047] The tool 302 may be configured to operate a package inspection program. For example, the tool 302 may operate a system 305 for inspecting packages to determine if they contain a sterile breach. In some embodiments, the system 305 may include at least one processor 306 and at least one memory 308 stored in the tool 302. The at least one memory may work with the at least one processor to cause the system to operate. For example, the at least one memory 308 and the at least one processor 306 may cause the system 305 to inspect a package to determine if it contains a sterile breach.

[0048] The system 305 may cause the user interface 304 to display a package selection screen 310 of the package inspection program. The package selection screen 310 may enable the system 305 to receive a package input or a user input from a user. The package selection screen 310 includes four package type options, option 312 for “Package 1”, option 314 for “Package 2”, option 316 for “Package 3”, and option 318 for “Package 4”. The user 300 may select the option 312, the option 314, the option 316, or the option 318 that corresponds to the package type of a package that they are inspecting. For example, if the package 200 corresponds to the option 312, the user 300 would select the option 312 on the tool 302 when they want to inspect the package 200. Once either the option 312, the option 314, the option 316, or the option 318 is selected, the system 305 may load comparative breach data corresponding to the selected option. The comparative breach data may be historical data of damaged packages. For example, the comparative breach data may be images of packages that contain sterile breaches that are stored locally on the tool 302 or in a cloud location or other remote storage location that can be accessed by the tool 302. Once the package type is selected on the package selection screen 310, the system 305 may load the comparative breach data corresponding to the package type from either local storage of the tool 302 or from a remote storage location.

[0049] Referring to Figure 4, the tool 302 is shown scanning a package 400. The package 400 may include a first surface 402 and a second surface 404 opposite the first surface 402. The package 400 may further include a central portion 406 and a periphery 408 surrounding the central portion 406. The first surface 402 and the second surface 404 may be coupled together along the periphery 408 of the package 400 such that a dressing or a kit may be stored in the central portion 406 of the package 400 between the first surface 402 and the second surface 404. The first surface 402 of the central portion 406 may include barcodes 410 and other package identifiers 412. In some embodiments the barcodes 410 and the other package identifiers 412 may be configured to identify the package 400.

[0050] The tool 302 may be a smart phone or another type of tool that includes a lens 420. In some embodiments, the lens 420 may be coupled to a camera of the tool 302. In other embodiments, the lens 420 may be coupled to a laser or other light source that is configured to work with the tool 302 as a LIDAR scanner or as another orientation and distance -correcting scanner. Dashed lines 422 show the tool 302 scanning the package 400. The tool 302 is configured to scan the entirety of the first surface 402 of the package 400. In some embodiments, after the tool 302 scans the first surface 402 of the package 400, the package 400 may be flipped so that the second surface 404 of the package 400 can also be scanned with the tool 302. If the tool 302 uses a LIDAR scanner to scan the package 400, the LIDAR scanner be an eye safe 1000 nanometer laser. The tool 302 may be configured to detect possible sterile breaches that are nanometers in size and that are not visible to the human eye.

[0051] Referring to Figures 5A and 5B, the tool 302 is shown with a package image 500 displayed on the user interface 304. The package image 500 may be an image created from the scan of the package 400 from Figure 4. Figure 5A shows the package image 500 in its entirety while Figure 5B shows the package image 500 zoomed in to the relevant location of the package image 500 that may be of interest to the user 300. In some embodiments, possible breach locations may be identified on the package image 500. For example, a first possible breach location 502 may be identified by a first circle 504 and a second possible breach location 506 may be identified by a second circle 508. In other embodiments, the possible breach locations may be identified by a different symbol or surrounding shape to make the user 300 aware of the possible breach locations on the package image 500.

[0052] In some embodiments, the possible breach locations such as the first possible breach location 502 and the second possible breach location 506 may be identified by comparing the package image 500 to the comparative breach data that was loaded when the package type was selected with the package selection screen 310. Locations of the package image 500 that resemble sterile breaches of the comparative breach data may be identified as possible breach locations and may be identified on the package image 500 to alert the user 300 that the package that was scanned may contain one or more possible sterile breaches.

[0053] As shown in Figures 5A and 5B, the first possible breach location 502 may be a hole through the first surface 402 of the package 400. In some embodiments, the hole may be too small to see clearly when the package image 500 is shown in its entirety but may be clearer when viewing a zoomed in image of the package image 500. The second possible breach location 506 may be a fold in an edge of the package 400. In some instances, it may not be clear whether the second possible breach location 506 is a sterile breach. For example, a fold in the package 400 may indicate that the package contains a broken seal which would be a sterile breach of the package 400. The second possible breach location 506 may be identified so that it can be more closely examined to determine if it is a sterile breach of the package 400.

[0054] Referring to Figure 6, the tool 302 is shown reexamining the package 400. More specifically, the tool 302 is directed towards the first possible breach location 502 and is rescanning the first possible breach location 502. Dashed lines 602 show the tool 302 scanning the first possible breach location 502 of the package 400. In some embodiments, the tool 302 may be tilted and angled around the first possible breach location 502 to rescan the first possible breach location 502 from multiple angles to obtain a first possible breach image of the first possible breach location 502. Scanning the first possible breach location 502 from multiple angles may provide a more complete image that can be compared to the comparative breach data to determine if the first possible breach location 502 is a true breach.

[0055] After the first possible breach location 502 is rescanned, the second possible breach location 506 may be rescanned. Similar to the first possible breach location 502, the second possible breach location 506 may be scanned from multiple angles to obtain a second possible breach image of the second possible breach location 506.

[0056] Referring to Figure 7, the tool 302 is shown with a package image 700 displayed on the user interface 304. The package image 700 may be similar to the package image 500 but may be modified with data from the reexamination or rescanning of the first possible breach location 502 and the second possible breach location 506 of the package 400.

[0057] The package image 700 may be generated by the system 305 after the first possible breach location 502 and the second possible breach location 506 are rescanned by the tool 302. The package image 700 may then be compared to the comparative breach data to determine whether the first possible breach location 502 or the second possible breach location 506 are true breaches. More specifically, the first possible breach image and the second possible breach image may be compared to the comparative breach data to determine if either the first possible breach location 502 or the second possible breach location 506 is a true breach. A true breach may be identified if the first possible breach image or the second possible breach image is similar to or the same as an identified breach located in the comparative breach data.

[0058] The package image 700 may include the first possible breach location 502 and the first circle 504 but may not include the second possible breach location 506 and the second circle 508. When comparing the first possible breach location 502 and the second possible breach location 506 to the comparative breach data, the first possible breach location 502 may have been identified as a true breach and the second possible breach location 506 may not have been identified as a true breach. For example, the system 305 may have determined that the second possible breach location 506 was a fold in the package 400 that did not breach the sterile environment of the package 400. The system 305 may have determined that the first possible breach location 502 was a pinhole that did breach the sterile environment of the package 400. The package image 700 may identify the first possible breach location 502 but may not identify the second possible breach location 506 because the system 305 determined that only the first possible breach location 502 was a true breach of the sterile environment of the package 400.

[0059] The system 305 may also cause the tool 302 to display two options on the user interface 304 with the package image 700. In some embodiments, the two options, such as a first option 702 and second option 704, may be images on the user interface 304 that the user 300 can select. The first option 702 may be an option to reject the package 400 and the second option 704 may be an option to accept the package 400. The first option 702 should be selected if the user 300 is going to discard the package 400 due to the first possible breach location 502 as identified by the system 305. In some embodiments, the second option 704 may display the language “Override rejection due to visual inspection.” The second option 704 may display “Override rejection due to visual inspection” because the first possible breach location 502 was identified by the system 305 as a true breach. The user 300 is given an opportunity to visually inspect the package 400 to determine if the first possible breach location 502 is not a true breach. If the user 300 determines that the first possible breach location 502 is not a true breach, the user 300 may select the second option 704 to override the system 305 and determine that the package 400 contains no breaches. This selection indicates that the contents of the package 400 can be used on a patient because the contents are sterile.

[0060] In some embodiments, if the system 305 identifies any true breaches, the system 305 may not allow the user 300 to override the rejection of the package 400. For example, if the system 305 determined that the first possible breach location 502 is a true breach, the system 305 may display a message on the user interface 304 of the tool 302 instructing the user 300 to discard the package 400 because it contains a sterile breach.

[0061] If the system 305 did not identify any true breaches, the user interface 304 may similarly display the first option 702 and the second option 704. The first option 702 may display the language “Reject” and the second option 704 may display the language “Accept.” If the system 305 does not identify any true breaches, it is assumed that the user 300 would accept the package 400 by selecting the second option 704. However, if the user 300 visually determines that there is something wrong with the package 400, the user 300 may need to reject the package by selecting the first option 702. In some embodiments, if the system 305 did not identify any true breaches and the package 400 is rejected by the user 300 selecting the first option 702, the system 305 may require the user 300 to input an explanation for why the package 400 was rejected. The user 300 may use the user interface 304 of the tool 302 to input the explanation.

[0062] Referring to Figure 8, the system 305 may cause a final selection screen 800 to be displayed on the user interface 304 of the tool 302. The final selection screen 800 may contain a first selection 802, a second selection 804, and a third selection 806. Each of the first selection 802, the second selection 804, and the third selection 806 may be options or buttons that the user 300 may select on the user interface 304 of the tool 302. The first selection 802 may display the language “Send Data to 3M/KCI” and may send data collected from the package inspection program to 3M/KCI or another specified location. For example, the package image 500, the first possible breach image, the second possible breach image, and the package image 700 may be included in the data that can be reported. In some embodiments, the data may be used to supply more information to an artificial intelligence system so that the system 305 is better able to identify possible breach location of any future packages. For example, reporting the data may add the data into the comparative breach data so that the system 305 is updated with the new information from the package 400. In some embodiments, the first selection 802 may not be included and the data may automatically be reported.

[0063] The second selection 804 may display the language “Order More Dressing Kits.” In some embodiments, the second selection 804 may not be displayed if the package 400 is accepted. The second selection 804 may allow the user 300 to place an order for additional packages if the package 400 is rejected.

[0064] The third selection 806 may display the language “Contact 3M/KCI.” The third selection may allow the user 300 to reach a help desk or a person, website, or system that may be able to answer any questions that the user 300 may have. For example, if the user 300 had a question about the options on the final selection screen 800 or a question about the package 400 and any possible breaches of the package 400, the user 300 may select the third selection 806.

[0065] Referring to Figures 9A and 9B, a method or system for scanning or inspecting sterile packaging on an assembly line is shown. It may be advantageous to use LIDAR technology to scan packaging at the end of an assembly line during the manufacturing process where the packaging is filled with contents and sealed. The LIDAR technology may be configured to scan the packaging to determine if the packaging contains broken seals, pin holes, or other damage to the packaging that may cause a breach to the sterile environment of the packaging. The LIDAR technology may further be configured to scan the packaging to determine if the packaging contains a product. For example, the LIDAR technology may be able to determine if the packaging is empty in some embodiments. In other embodiments, the LIDAR technology may be able to determine if the packaging contains the correct product. For example, if the packaging should contain a negative pressure wound therapy canister but it contains a dressing, the LIDAR technology may scan the packaging and the system may be able to determine this error. In some embodiments, LIDAR technology may be implemented throughout an assembly line of the manufacturing process so that any processes or steps that result in damaged or incorrect packaging may be determined. By implementing LIDAR technology into the manufacturing process, fewer damaged or incorrect packages may be put into the stream of commerce which may benefit both health care providers and patients.

[0066] Referring to Figure 9A, a system 900 is shown. The system 900 may include an assembly line 902 and a plurality of scanners 904. In some embodiments, the plurality of scanners 904 may include a first scanner 906, a second scanner 908, a third scanner 910, and a fourth scanner 912. In some embodiments, the plurality of scanners 904 may each be a LIDAR scanner. In other embodiments, the plurality of scanners 904 may each be another orientation and distance-correcting scanner. Light 914 may be emitted from each of the plurality of scanners 904 when each of the plurality of scanners 904 is operating. For example, a first light 916 may be emitted from the first scanner 906, a second light 918 may be emitted from the second scanner 908, a third light 920 may be emitted from the third scanner 910, and a fourth light 922 may be emitted from the fourth light. The light 914 may be light from lasers of the plurality of scanners 904. The first light 916, the second light 918, the third light 920, and the fourth light 922 may cover the entirety of the assembly line 902. In other embodiments, there may be fewer or additional scanners similar to the plurality of scanners 904 to scan the entirety of the assembly line 902.

[0067] A package on the assembly line 902 may move from a first end 924 of the assembly line 902 to a second end 926 of the assembly line 902 as demonstrated by an arrow 928. The package may reach a first outer bound 930 of the plurality of scanners 904 and may move through the light 914 to reach a second outer bound 932 of the plurality of scanners 904. The plurality of scanners 904 may each scan an area of the package that passed through the light 914 corresponding to a given scanner of the plurality of scanners 904. A scanned image of the package may be generated by the plurality of scanners 904 and may be transmitted to a controller or a computer or another device capable of processing the scanned image. In other embodiments, the plurality of scanners 904 may transmit data collected from scanning the package to the controller or the computer and the controller or the computer may generate the scanned image. The controller or computer may include or be able to access a database of images. The database of images may be a database or another storage location that contains images of packages that contain damaged locations or incorrect contents and packages that are sterile and contain the correct contents. The controller or computer may compare the scanned image to the database of images and may determine whether the package is damaged or if the package is missing contents or contains the wrong contents. The controller or the computer may then be configured to generate a message that a user can receive that indicates whether the package can be shipped to a customer or whether it should be discarded.

[0068] Referring to Figure 9B, a system 945 is shown. The system 945 can include a scanner 950 and an assembly line 952. The scanner 950 is shown scanning a package 954 on the assembly line 952. A light 956 may be emitted by the scanner 950 that may be similar to the light 914 described above with reference to Figure 9A. The light 956 may extend from a first edge 958 of the assembly line 952 to a second edge 960 of the assembly line 952. Thus, the scanner 950 is capable of scanning the assembly line 952 in its entirety. Similar to the assembly line 902, the package 954 may move from a first end 962 of the assembly line 952 to a second end 964 of the assembly line 952. The scanner 950 may scan the package 954 beginning with a first end 966 and ending with a second end 968 as the package 954 moves along the assembly line 952. Similar to the plurality of scanners 904 of Figure 9A, the scanner 950 may generate a scanned image that may be transmitted to a controller or a computer or another device capable of processing the scanned image. In other embodiments, the scanner 950 may transmit data collected from scanning the package 954 to the controller or the computer and the controller or the computer may generate the scanned image. The controller or computer may include or be able to access a database of images. The database of images may be a database or another storage location that contains images of packages that contain damaged locations or incorrect contents and packages that are sterile and contain the correct contents. The controller or computer may compare the scanned image to the database of images and may determine whether the package is damaged or if the package is missing contents or contains the wrong contents. The controller or the computer may then be configured to generate a message that a user can receive that indicates whether the package can be shipped to a customer or whether it should be discarded.

[0069] Also described herein is a method of inspecting sterile packaging such as the package 400. The method may include providing the package 400 for inspection and providing a device such as the tool 302 having inspection capabilities. The method may further include selecting a package inspection program on the tool 302 and identifying a package type, in the package inspection program, corresponding to the package 400. The method may then include loading comparative breach data that corresponds to the package type. Next, the method can include scanning the package 400 with the tool 302 to create the package image 500. The method can then include comparing the package image 500 to the comparative breach data to identify possible breach locations. Once the possible breach locations are identified, the method can include reexamining, with the tool 302, the possible breach locations and determining whether to reject or accept the package 400.

[0070] In some embodiments, reexamining, with the tool 302, the possible breach locations can include scanning, with the tool 302, each of the possible breach locations from more than one angle and evaluating, with the device, whether each of the possible breach locations is a breach location.

[0071] In some embodiments, the method can further include visually inspecting each possible breach location. In other embodiments, the method can further include reporting data associated with scanning the package with the device and reexamining, with the device, the possible breach locations to a reporting destination.

[0072] The systems and methods described herein may provide significant advantages. For example, the systems and methods may assist or eliminate the need for physicians or other health care providers to visually inspect packaging prior to opening the packaging. Further, the systems and methods may provide a more accurate way to determine if a package has a sterile breach rather than inspecting the package with the human eye which may result in fewer contaminated dressings or kits being used at tissue sites. Additionally, the system 900 and the system 945 may ensure that damaged or incorrect packages are discovered during the manufacturing process so that they never reach customers.

[0073] While shown in a few illustrative embodiments, a person having ordinary skill in the art will recognize that the systems, apparatuses, and methods described herein are susceptible to various changes and modifications that fall within the scope of the appended claims. Moreover, descriptions of various alternatives using terms such as “or” do not require mutual exclusivity unless clearly required by the context, and the indefinite articles "a" or "an" do not limit the subject to a single instance unless clearly required by the context.

[0074] The appended claims set forth novel and inventive aspects of the subject matter described above, but the claims may also encompass additional subject matter not specifically recited in detail. For example, certain features, elements, or aspects may be omitted from the claims if not necessary to distinguish the novel and inventive features from what is already known to a person having ordinary skill in the art. Features, elements, and aspects described in the context of some embodiments may also be omitted, combined, or replaced by alternative features serving the same, equivalent, or similar purpose without departing from the scope of the invention defined by the appended claims.

Claims

CLAIMS What is claimed is:

1. A method of inspecting sterile packaging comprising: providing a package for inspection; providing a device having inspection capabilities; selecting a package inspection program on the device; identifying a package type, in the package inspection program, corresponding to the package; loading comparative breach data corresponding to the package type; scanning the package with the device to create a package image; comparing the package image to the comparative breach data to identify possible breach locations; reexamining, with the device, the possible breach locations; and determining whether to reject or accept the package.

2. The method of claim 1, wherein the device comprises a smart phone.

3. The method of claim 1, wherein scanning the package with the device comprises scanning the package with a LIDAR scanner.

4. The method of claim 1, wherein scanning the package with the device comprises scanning the package with an orientation and distance-correcting scanner.

5. The method of claim 1, wherein reexamining, with the device, the possible breach locations comprises: scanning, with the device, each of the possible breach locations from more than one angle; and evaluating, with the device, whether each of the possible breach locations is a breach location.

6. The method of claim 5, further comprising visually inspecting each possible breach location.

7. The method of claim 1, further comprising reporting data associated with scanning the package with the device and reexamining, with the device, the possible breach locations to a reporting destination.

8. The method of claim 1, wherein, if the package is rejected, outputting, on the device, an option to order additional packages.

9. The method of claim 1, wherein the package comprises packaging including reflective material.

10. The method of claim 9, wherein scanning the package with the device includes using the reflective material to identify the possible breach locations.

11. A system for inspecting a sterile package, comprising: a processor; a memory; and a device for scanning a sterile package; wherein the memory is configured with the processor to cause the system to perform, in response to receiving a package input: loading comparative breach data corresponding to the package input; scanning the sterile package with the device to create a package image; comparing the package image to the comparative breach data to identify damaged locations of the sterile package; and causing the device to display an option to accept or reject the sterile package.

12. The system of claim 11, wherein, if a damaged location is identified, the memory causes the system to further perform reexamining the damaged location.

13. The system of claim 12, wherein reexamining the damaged location comprises scanning the damaged location from more than one angle.

14. The system of claim 11, wherein the package input is a user input identifying the sterile package to be scanned.

15. The system of claim 11, wherein the device comprises a smart phone with LIDAR scanning capabilities or other orientation and distance-correcting scanning capabilities.

16. The system of claim 11, wherein the memory causes the system to further perform sending, to a cloud location, data associated with the package image.

17. The system of claim 11, wherein the memory causes the system to further perform causing the device to display an option to order additional packages to replace the sterile package if the sterile package is declined.

18. The system of claim 11, wherein the comparative breach data is historical data of damaged packages.

19. The system of claim 11, wherein the damaged locations are pinholes in the sterile package.

20. The system of claim 11, wherein the damaged locations are broken seals on the sterile package.

21. The systems, apparatuses, and methods substantially as described herein.