EP-4740218-A1 - SYSTEMS AND METHODS FOR DEVICE HISTORY DOCUMENTATION

Abstract

Surgical systems and methods are provided. The surgical systems include a manufacturer-sealed sterile surgical package containing a surgical instrument, at least one data processor, and memory storing instructions configured to cause the at least one data processor to perform operations. The operations include update a historical record of the surgical package and/or the surgical instrument based on at least one of a current geo-political location and a supply-chain progression of the surgical system, and provide, based on at least one of the current geo-political location and the supply-chain progression of the surgical system, handling instructions for the surgical system.

Inventors

• SHELTON, IV, FREDERICK E.
• ARONHALT, Jacqueline C.
• SCHINGS, BRIAN
• BAKOS, GREGORY J.
• RECTOR, JASON
• FIEBIG, KEVIN M.
• ADAMS, SHANE R.
• ARONHALT, TAYLOR W.

Assignees

• Cilag GmbH International

Dates

Publication Date

20260513

Application Date

20240708

Claims (20)

1. 1. A surgical system, comprising: a manufacturer-sealed sterile surgical package containing a surgical instrument; at least one data processor disposed in the surgical package; and memory disposed in the surgical package and storing instructions configured to cause the at least one data processor to perform operations comprising: update a historical record of the surgical package and/or the surgical instrument based on at least one of a current geo-political location and a supply-chain progression of the surgical system, and provide, based on at least one of the current geo-political location and the supplychain progression of the surgical system, handling instructions for the surgical system.
2. 2. The surgical system of claim 1 , wherein the handling instructions include information characterizing at least one of historic states, future states, and operational information.
3. 3. The surgical system of claim 2, wherein the historic states include at least one of manufacturing information, materials and components information, geographical origin information, and environmental information experienced by the surgical package.
4. 4. The surgical system of claim 2 or 3, wherein the future states include at least one of an intended destination information, environmental requirements information, customs information, disposal information, and error reporting procedures information.
5. 5. The surgical system of claim 2, 3 or 4, wherein the operational information includes at least one of product compatibility information, expected lifecycle information, and operational instructions.
6. 6. The surgical system of any preceding claim, wherein the at least one data processor is further configured to provide, based on an on-demand user request, at least a portion of the historical record.
7. 7. The surgical system of claim 6, wherein the on-demand user request is pre-authenticated.
8. 8. The surgical system of any preceding claim, wherein the handling instructions are provided via a display located on the manufacturer-sealed sterile surgical package.
9. 9. The surgical system of any preceding claim, wherein the handling instructions include a list of one or more surgical items for a surgical procedure involving the surgical instrument.
10. 10. The surgical system of any preceding claim, wherein the handling instructions are transmitted and displayed on a remote device in electronic communication with the manufacturer-sealed sterile surgical package.
11. 11. The surgical system of any preceding claim, wherein the handling instructions are displayed on at least one display disposed on the manufacturer-sealed sterile surgical package.
12. 12. The surgical system of claim 11, wherein the at least one display comprises at least one e- ink label.
13. 13. A method, comprising: updating, with a surgical system, a historical record of the surgical system based on at least one of a current geo-political location and a supply-chain progression of the surgical system; and providing, with the surgical system and based on at least one of the current geo-political location and the supply-chain progression of the surgical system, handling instructions for the surgical system; wherein the surgical system includes a manufacturer-sealed sterile surgical package containing a surgical instrument.
14. 14. The method of claim 13, wherein the handling instructions include information characterizing at least one of historic states, future states, and operational information.
15. 15. The method of claim 14, wherein the historic states include at least one of manufacturing information, materials and components information, geographical origin information, and environmental information experienced by the surgical package.
16. 16. The method of claim 14 or 15, wherein the future states include at least one of an intended destination information, environmental requirements information, customs information, disposal information, and error reporting procedures information.
17. 17. The method of claim 14, 15 or 16, wherein the operational information includes at least one of product compatibility information, expected lifecycle information, and operational instructions.
18. 18. The method of any one of claims 13 to 17, further comprising providing, based on an on- demand user request, at least a portion of the historical record.
19. 19. The method of claim 18, wherein the on-demand user request is authenticated prior to providing the at least a portion of the historical record.
20. 20. The method of any one of claims 13 to 19, wherein the handling instructions are provided via a display located on the manufacturer-sealed sterile surgical package.

Description

SYSTEMS AND METHODS FOR DEVICE HISTORY DOCUMENTATION CROSS-REFERENCE TO RELATED APPLICATION [0001] This application claims the benefit of and priority to U.S. Provisional Application No. 63/525,572, filed July 7, 2023, the contents of which is herein incorporated by reference in its entirety. FIELD [0002] The present disclosure relates generally to smart surgical devices, systems, and methods. BACKGROUND [0003] Surgical instruments are manufactured to meet specific performance metrics in order to ultimately perform a surgical procedure in a safe and effective manner. Following manufacture, surgical instruments are shipped all over the world to hospitals and surgical centers, and along the supply chain, the surgical instruments are handled by a variety of persons, including transit operators, warehouse operators, customs officials, hospital staff, surgical teams, and more. [0004] While safe and effective performance of the surgical instrument is the goal, problems can arise. In some cases, problems with the surgical instrument may arise due to manufacturing issues. In other cases, problems may arise as a result of mishandling during transit, such as improper storage techniques or extreme environmental phenomena. In still other cases, problems may arise as a result of incompatibility with other surgical equipment or improper usage in an operating room during a surgical procedure. [0005] Accordingly, there remains a need for improved surgical systems and methods. SUMMARY [0006] Surgical systems and methods are provided. In one embodiment, a surgical system is provided that includes a manufacturer-sealed sterile surgical package containing a surgical instrument configured to be used in a surgical procedure, at least one data processor, and memory storing instructions. The instructions can be configured to cause the at least one data processor to perform operations including to catalogue components of the surgical instrument, determine disposal procedures for each of the components of the surgical instrument, and provide the disposal procedures at the end of the surgical procedure. [0007] The surgical system can vary in a number of ways. For example, the memory can store instructions configured to cause the at least one data processor to perform operations including track the disposal procedures for each component of the surgical instrument, determine an accuracy level of the disposal procedures for each tracked component, provide the accuracy level. In other aspects, the memory can store instructions configured to cause the at least one data processor to perform operations including receive data characterizing available disposal options at a healthcare site hosting the surgical procedure, adjust the disposal procedures based on the received data, and provide the adjusted disposal procedures. In other embodiments, the memory can store instructions configured to cause the at least one data processor to perform operations including receive data characterizing a geopolitical location of a healthcare site hosting the surgical procedure, adjust the disposal procedures based on the received data, and provide the adjusted disposal procedures. In other aspects, the memory can store instructions configured to cause the at least one data processor to perform operations including receive data characterizing a performance error of the surgical instrument, adjust the disposal procedures based on the received data, and provide the adjusted disposal procedures. In some variations, the adjusted disposal procedures can include a return address for the surgical instrument. The guidance can include instructions for disassembly, compartmentalization, and/or separation of the catalogued components of the surgical procedure. In other embodiments, the disposal procedures can be provided via a display located on the manufacturer-sealed sterile surgical package, such as an e- ink label and/or a colored LED located on the manufacturer-sealed sterile surgical package, with a color of the colored LED corresponding to a color of one or more disposal bins located within an operating room hosting the surgical procedure. In other embodiments, the disposal procedures can be transmitted and displayed on a remote device in electronic communication with the manufacturer-sealed sterile surgical package. [0008] In another embodiment, a method is provided including cataloguing, by a manufacturer- sealed sterile surgical package, components of a surgical instrument contained within the manufacturer-sealed sterile surgical package and used in a surgical procedure, determining disposal procedures for each of the components of the surgical instrument, and providing the disposal procedures at the end of the surgical procedure. [0009] The method can vary in a number of ways. For example, the method can include tracking the disposal procedures for each component of the surgical instrument, determining an accuracy level of the disposal procedures for eac