# US 12,213,846 B2 · Apparatus and method to inspect microlumen of catheter > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,213,846 B2 - Document ID: US12213846B2 - Status: Granted - Kind: B2 - Application number: 17/406,141 - Filed: 2021-08-19 - Published: 2023-02-23 - Granted: 2025-02-04 - Earliest claimed: 2021-08-19 - Assignees: Sterilmed, Inc. - Applicants: SterilMed, Inc. - Inventors: Jason Hill - Web page: https://patentgrep.com/patent/US12213846B2 ## CPC - A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)} - A61B 90/70: Cleaning devices specially adapted for surgical instruments - A61B 1/00057: {provided with means for testing or calibration} - A61B 1/121: {provided with means for cleaning post-use} - B08B 9/04: using cleaning devices introduced into and moved along the pipes - G01N 7/00: Analysing materials by measuring the pressure or volume of a gas or vapour - A61B 2018/00351: {Heart} - A61B 2018/00577: {Ablation} - A61B 2018/00863: {Fluid flow} - A61B 2090/701: {for flexible tubular instruments, e.g. endoscopes} - A61B 2090/702: {Devices for testing the cleaning process, e.g. test soils} - A61B 2217/002: Auxiliary appliance - A61M 2025/0019: {Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement} - A61M 2205/0266: Shape memory materials - A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means - B08B 2209/04: using cleaning devices introduced into and moved along the pipes - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - B08B: CLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract A lumen inspection device includes an elongate member and a sealing member at a distal end of the elongate member. The elongate member is inserted into a lumen of a medical instrument. The lumen inspection device is translated along the lumen. The sealing member resiliently bears against a sidewall of the lumen as the lumen inspection device is translated along the lumen of the medical instrument. A pressure source is activated to pressurize a region of the lumen adjacent to the sealing member. A fluid property of the lumen is monitored to detect whether the sealing member deforms in response to an obstruction in the lumen. ## Claims ### Claim 1 A method comprising: (a) inserting an elongate member of a lumen inspection device in a lumen of a medical instrument; (b) translating the lumen inspection device along the lumen of the medical instrument, the lumen inspection device including a sealing member, the sealing member resiliently biasing against a sidewall of the lumen as the lumen inspection device is translated along the lumen of the medical instrument, the resilient biasing of the sealing member resulting in a resilient force being applied to the sidewall of the lumen; (c) activating a pressure source to pressurize a region of the lumen adjacent to the sealing member; and (d) monitoring a fluid flow rate or a fluid pressure of the pressurized region of the lumen while translating the lumen inspection device and activating the pressure source, to thereby detect whether the sealing member deforms in response to an obstruction in the lumen. ### Claim 2 (depends on 1) The method of claim 1, the elongate member comprising a wire. ### Claim 3 (depends on 2) The method of claim 2, the wire comprising nitinol. ### Claim 4 (depends on 1) The method of claim 1, the medical instrument comprising a catheter. ### Claim 5 (depends on 4) The method of claim 4, the catheter having an end effector with one or more electrodes. ### Claim 6 (depends on 5) The method of claim 5, the lumen having a distal opening at the end effector. ### Claim 7 (depends on 1) The method of claim 1, the act of inserting comprising inserting the elongate member into a distal opening of the lumen, the distal opening being positioned at a distal end of a shaft assembly of the medical instrument. ### Claim 8 (depends on 1) The method of claim 1, the act of translating comprising pulling the lumen inspection device proximally through the lumen. ### Claim 9 (depends on 1) The method of claim 1, the act of translating comprising translating the lumen inspection device at a constant rate of translation. ### Claim 10 (depends on 1) The method of claim 1, the lumen inspection device being configured such that a proximal portion of the lumen inspection device extends proximally from a handle of the medical instrument during at least part of the act of translating. ### Claim 11 (depends on 10) The method of claim 10, the handle including a port, the port forming a fluid tight seal around the elongate member during the act of translating. ### Claim 12 (depends on 11) The method of claim 11, the act of activating including activating a pressure source to communicate pressurized fluid to the lumen via the port. ### Claim 13 (depends on 1) The method of claim 1, the act of activating comprising communicating pressurized air to a region of the lumen that is proximal to the sealing member. ### Claim 14 (depends on 1) The method of claim 1, the act of monitoring comprising monitoring a fluid flow rate through the lumen. ### Claim 15 (depends on 1) The method of claim 1, further comprising: (a) comparing the monitored fluid flow rate or fluid pressure to a baseline value; and (b) determining that the lumen contains an obstruction in response to the monitored fluid flow rate or fluid pressure exceeding the baseline value. ### Claim 16 (depends on 1) The method of claim 1, further comprising: (a) determining that an obstruction is present in the lumen based on a change in the monitored fluid flow rate or fluid pressure; and (b) alerting an operator in response to determining that the obstruction is present in the lumen. ### Claim 17 An apparatus, comprising: (a) an elongate wire having a proximal end and a distal end; (b) a stop member fixedly secured to the distal end of the elongate wire; and (c) a sealing member, the sealing member including a flared portion, the flared portion being resiliently biased to define a frustoconical shape, the sealing member having an interior region, the stop member being positioned within an interior region of the frustoconical shape, the stop member being configured to restrict distal translation of the sealing member relative to the elongate wire, the flared portion being configured to deflect inwardly to thus break a fluid seal between the sealing member and a lumen upon encountering a contaminant between the sealing member and the lumen. ### Claim 18 (depends on 17) The apparatus of claim 17, the sealing member being slidably disposed on the elongate wire. ### Claim 19 A kit, comprising: (a) a medical instrument having a shaft defining a lumen; (b) a lumen inspection device comprising: (i) a flexible elongate member having a distal end, and (ii) a sealing member at the distal end of the flexible elongate member, the lumen inspection device being configured to translate through the lumen, the sealing member having a resilient bias with a flared configuration such that the sealing member is configured to resiliently bias against a sidewall of the lumen as the lumen inspection device translates through the lumen; (c) a pressure source operable to pressurize a region of the lumen adjacent to the sealing member as the lumen inspection device translates through the lumen; and (d) a fluid parameter monitor operable to monitor a fluid flow rate or a fluid pressure of fluid in the lumen as the lumen inspection device translates through the lumen, to thereby detect whether the sealing member deforms in response to an obstruction in the lumen. ### Claim 20 (depends on 19) The kit of claim 19, the medical instrument further including an end effector positioned at a distal end of the shaft, the end effector including one or more electrodes, the lumen having a distal opening at the end effector.