# US 11,439,720 B2 · Method and apparatus to evaluate internal flexible endoscope channels in the context of endoscope ports and channel complexities > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,439,720 B2 - Document ID: US11439720B2 - Status: Granted - Kind: B2 - Application number: 16/542,734 - Filed: 2019-08-16 - Published: 2021-02-18 - Granted: 2022-09-13 - Earliest claimed: 2019-08-16 - Assignees: American Sterilizer Company - Applicants: American Sterilizer Company - Inventors: Nancy A. Robinson - Web page: https://patentgrep.com/patent/US11439720B2 ## CPC - A61L 2/28: Devices for testing the effectiveness or completeness of sterilisation or disinfection, e.g. indicators which change colour - A61B 1/121: {provided with means for cleaning post-use} - A61B 90/70: Cleaning devices specially adapted for surgical instruments - A61B 2090/701: {for flexible tubular instruments, e.g. endoscopes} - A61B 2090/702: {Devices for testing the cleaning process, e.g. test soils} - A61L 2103/15: Laboratory, medical or dentistry appliances, e.g. catheters or sharps - A61L 2202/17: Combination with washing or cleaning means - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract A test instrument and a method for producing a test instrument used to evaluate a cleaning, disinfection and/or drying processes of internal flexible channels includes obtaining a medical instrument having a flexible probe section configured for insertion into a body, the flexible probe section including at least one internal flexible channel and at least one external device port, and attaching an access device between the at least one external device port and the at least one internal flexible channel to enable selective access into the internal flexible channel. ## Claims ### Claim 1 A method for producing a test instrument used to evaluate decontamination process that includes at least one of a cleaning, disinfection or drying process of internal flexible channels, comprising: obtaining a medical instrument having a flexible probe section configured for insertion into a body, the flexible probe section including at least one internal flexible channel and at least one external device port; and attaching an access device between the at least one external device port and the at least one internal flexible channel to enable selective access into the internal flexible channel, wherein attaching the access device comprises removing an exterior sheath from the flexible probe section to expose the at least one external device port and the at least one internal flexible channel of the medical instrument. ### Claim 2 (depends on 1) The method according to claim 1, wherein attaching the access device comprises using at least one of a tubing connector or a threaded connector as the access device. ### Claim 3 (depends on 1) The method according to claim 1, wherein obtaining the medical instrument comprises obtaining a medical instrument that has at least one of exceeded a predetermined service life or become inoperable. ### Claim 4 (depends on 1) The method according to claim 1, wherein the medical instrument comprises a handle section for operating the medical instrument, the handle section connected to the flexible probe section, wherein attaching the access device comprises placing the access device within the handle section. ### Claim 5 (depends on 4) The method according to claim 4, wherein attaching the access device comprises attaching a valve cylinder in the handle section to provide selective access to the at least one channel. ### Claim 6 (depends on 1) The method according to claim 1, wherein obtaining the medical instrument comprises obtaining a flexible endoscope having a flexible probe section with a distal end surface configured for insertion into a body, the distal end surface including one external port of the at least one external port fluidically coupled to one internal channel of the at least one internal channel. ### Claim 7 (depends on 1) The method according to claim 1, wherein the at least one external port comprises at least one of a port for outputting a liquid, port for outputting air, or a port for evacuating the fluid or the air. ### Claim 8 A method for producing a test instrument used to evaluate decontamination process that includes at least one of a cleaning, disinfection or drying process of internal flexible channels, comprising: obtaining a medical instrument having a flexible probe section configured for insertion into a body, the flexible probe section including at least one internal flexible channel and at least one external device port; and attaching an access device between the at least one external device port and the at least one internal flexible channel to enable selective access into the internal flexible channel, wherein attaching the access device comprises replacing the flexible probe section with transparent tubing, the transparent tubing defining the at least one flexible internal channel. ### Claim 9 A method for evaluating internal flexible endoscope channels, comprising: producing a test instrument by obtaining a medical instrument having a flexible probe section configured for insertion into a body, the flexible probe section including at least one internal flexible channel and at least one external device port. and attaching an access device between the at least one external device port and the at least one internal flexible channel to enable selective access into the internal flexible channel. wherein attaching the access device comprises removing an exterior sheath from the flexible probe section to expose the at least one external device port and the at least one internal flexible channel of the medical instrument; introducing, via the access device, at least one contaminant o at least a portion of the test instrument; performing a decontamination step on the test instrument; and evaluating the test instrument to determine if the decontamination step produced a predetermined level of removal/destruction of the contaminant. ### Claim 10 (depends on 9) The method according to claim 9, wherein introducing the at least one contaminant comprises introducing a fluid into the test instrument. ### Claim 11 (depends on 10) The method according to claim 10, wherein performing the decontamination step comprises exposing the test instrument to a drying process. ### Claim 12 (depends on 9) The method according to claim 9, wherein evaluating the test instrument comprises at least one of performing a visual inspection for residual contaminant in the at least one channel, determining the presence of the at least one contaminant in the test instrument based on a weight of the test instrument before introducing the at least one contaminant and a weight of the test instrument after performing the decontamination step, or exposing the test instrument to dry compressed air and capturing residual contaminant expelled from the test instrument. ### Claim 13 (depends on 9) The method according to claim 9, wherein introducing the at least one contaminant comprises placing at least one of a liquid inoculum or biological indicators containing a challenge organism into the test instrument. ### Claim 14 (depends on 13) The method according to claim 13, wherein placing the biological indicators comprises inserting the at least one of the liquid inoculum or biological indicators into the test instrument via the access device. ### Claim 15 (depends on 14) The method according to claim 14, wherein inserting the biological indicators comprises opening the access device and inserting the at least one of the liquid inoculum or the biological indicators into the at least one channel of the test instrument via the access device. ### Claim 16 (depends on 13) The method according to claim 13, wherein performing the decontamination step comprises disinfecting the test instrument. ### Claim 17 (depends on 13) The method according to claim 13, wherein evaluating the test instrument comprises removing the biological indicators from the test instrument and placing the removed biological indicators into a culture media. ### Claim 18 (depends on 9) The method according to claim 9, wherein introducing the at least one contaminant comprises growing a biofilm within a section of tubing, and inserting the tubing into the test instrument. ### Claim 19 (depends on 18) The method according to claim 18, wherein performing the decontamination step comprises removing the biofilm from the test instrument. ### Claim 20 (depends on 18) The method according to claim 18, wherein evaluating the test instrument comprises at least one of evaluating the test instrument for remaining biofilm, flushing sections of the test instrument with a harvest media and evaluating the flushed harvest media for the presence of a predetermined components, placing the removed biofilm in a growth media and evaluating for further growth, or applying a biofilm stain to identify the presence of the biofilm. ### Claim 21 (depends on 9) The method according to claim 9, wherein the access device comprises at least one of a screw fitting or a quick connect of the test instrument. ### Claim 22 A test instrument for performing at least one of a cleaning, sterilization, or drying evaluation, comprising: a handle; a flexible probe configured for insertion into a body, the flexible probe including a proximal end connected to the handle, at least one port, and at least one flexible internal channel, the at least one port connecting the at least one flexible internal channel to an exterior of the test instrument; and an access device connected to the at least one internal channel and configured to enable selective access into the at least one flexible internal channel for insertion and/or removal of a contaminant, wherein an exterior sheath of the flexible probe section has been removed to expose the at least one external device port and the at least one internal flexible channel of the medical instrument, and the access device is installed at the exposed region of the at least one internal flexible channel. ### Claim 23 (depends on 22) The test instrument according to claim 22, further comprising a tip connected to a distal end of the flexible probe section, the tip including the at least one port. ### Claim 24 (depends on 22) The test instrument according to claim 22, wherein the access device comprises a removable junction connecting a first internal channel to both a second internal channel and a third internal channel. ### Claim 25 (depends on 24) The test instrument according to claim 24, wherein the removable junction comprises a Y junction. ### Claim 26 (depends on 24) The test instrument according to claim 24, wherein the removable junction comprises a two-port removable connector that joins at least two flexible internal channels to each other. ### Claim 27 (depends on 22) The test instrument according to claim 22, wherein the access devices enables visual access into the at least one flexible internal channel.