US-12616358-B2 - Rigidizing sheath apparatus for an endoscope

Abstract

Methods for preventing contamination of an endoscope may include coupling a sheath device to cover both the inside and outside of the endoscope. The sheath device may include a rigidizing flexible tubular external sheath that extends over the endoscope to form an external protective barrier, a tubular internal sheath that extends within a lumen of the endoscope that forms an internal protective barrier, and a cap sealed to both the external sheath and the internal sheath. The sheath may be rigidized to enhance insertion.

Inventors

• Alexander Q. TILSON
• Thomas HSIU
• Niklas J. HELMICK
• Stephan T. Hoffmann
• Eugene Duval
• Christopher J. Hasser
• James M. Hayes
• Elias ELEFTHERIADES
• Kai POHLHAMMER

Assignees

• NEPTUNE MEDICAL INC.

Dates

Publication Date

20260505

Application Date

20250516

Claims (17)

1. 1 . A rigidizing sheath apparatus for converting an endoscope into a rigidizing endoscope, the apparatus comprising: a tubular outer sheath body, wherein the tubular outer sheath body comprises: a lumen extending through the tubular outer sheath body configured to ensheathe the endoscope within the lumen, a rigidizing layer comprising multiple strand lengths that cross over each other, and a compression layer that is configured to be driven against the rigidizing layer by the application of pressure to rigidize the tubular outer sheath body; a distal cap coupled to a distal end of the tubular outer sheath body and configured to engage a distal end region of the endoscope; and an internal sheath extending proximally from the distal cap within the lumen and configured to be inserted into a lumen of the endoscope.
2. 2 . The apparatus of claim 1 , wherein the tubular outer sheath body further comprises a pressure port configured to receive a positive or negative pressure, wherein the pressure port is in fluid communication with the compression layer.
3. 3 . The apparatus of claim 1 , wherein the compression layer is configured to be driven against the rigidizing layer by the application of positive pressure.
4. 4 . The apparatus of claim 1 , wherein the compression layer is configured to be driven against the rigidizing layer by the application of negative pressure.
5. 5 . The apparatus of claim 1 , wherein the compression layer comprises a bladder.
6. 6 . The apparatus of claim 1 , wherein the rigidizing layer comprises a braided, knit, or woven layer.
7. 7 . The apparatus of claim 1 , further comprising a second internal sheath within the tubular outer sheath body and extending proximally from the distal cap and configured to insert into a lumen of the endoscope.
8. 8 . The apparatus of claim 1 , wherein the internal sheath comprises a multi-lumen internal sheath.
9. 9 . The apparatus of claim 1 , wherein the cap comprises a cylindrical mating surface configured to be compressed to convert from a resting oval cross-sectional configuration into a substantially circular mating cross-sectional configuration to engage with the distal end region of the endoscope.
10. 10 . A rigidizing sheath apparatus for converting an endoscope into a rigidizing endoscope, the apparatus comprising: a tubular outer sheath body, wherein the tubular outer sheath body comprises: a lumen extending through the tubular outer sheath body configured to ensheathe the endoscope within the lumen, a pressure port configured to receive a positive or negative pressure, a rigidizing layer comprising multiple strand lengths that cross over each other, and a compression layer that is configured to be driven against the rigidizing layer by the application of fluid pressure from the pressure port to rigidize the tubular outer sheath body; a distal cap coupled to a distal end region of the tubular outer sheath body and configured to engage a distal end region of the endoscope; and an internal sheath extending proximally from the distal cap and configured to be inserted into a lumen of the endoscope.
11. 11 . The apparatus of claim 10 , wherein the compression layer is configured to be driven against the rigidizing layer by the application of positive pressure.
12. 12 . The apparatus of claim 10 , wherein the compression layer is configured to be driven against the rigidizing layer by the application of negative pressure.
13. 13 . The apparatus of claim 10 , wherein the compression layer comprises a bladder.
14. 14 . The apparatus of claim 10 , wherein the rigidizing layer comprises a braided, knit, or woven layer.
15. 15 . The apparatus of claim 10 , further comprising a second internal sheath within the tubular outer sheath body and extending proximally from the distal cap and configured to insert into a lumen of the endoscope.
16. 16 . The apparatus of claim 10 , wherein the internal sheath comprises a multi-lumen internal sheath.
17. 17 . The apparatus of claim 10 , wherein the cap comprises a cylindrical mating surface configured to be compressed to convert from a resting oval cross-sectional configuration into a substantially circular mating cross-sectional configuration to engage with the distal end region of the endoscope.

Description

CLAIM OF PRIORITY This patent application is a continuation of U.S. patent application Ser. No. 18/902,916, filed Sep. 30, 2024, titled “METHODS OF ATTACHING A RIGIDIZING SHEATH TO AN ENDOSCOPE,” now U.S. Patent Application Publication No. 2025/0025023, which is a continuation of U.S. patent application Ser. No. 18/582,634, filed Feb. 20, 2024, titled “METHODS OF ATTACHING A RIGIDIZING SHEATH TO AN ENDOSCOPE,” now U.S. Pat. No. 12,102,289, which is a continuation of U.S. patent application Ser. No. 18/325,979, filed May 30, 2023, titled “APPARATUSES AND METHODS FOR DETERMINING IF AN ENDOSCOPE IS CONTAMINATED,” now U.S. Patent Application Publication No. 2023/0346200, which claims priority as a continuation of International Patent Application No. PCT/US2023/066293, filed Apr. 27, 2023, titled “HYGIENIC SHEATH FOR ENDOSCOPY,” now International Publication No. WO 2023/212641, which claims priority to U.S. Provisional Patent Application No. 63/335,720, titled “HYGIENIC DRAPING FOR ROBOTIC ENDOSCOPY,” filed on Apr. 27, 2022. These applications are herein incorporated by reference in their entireties. INCORPORATION BY REFERENCE All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. BACKGROUND Reusable endoscopes (‘scopes’), both manually and robotically operated, perform important diagnostic and therapeutic functions, but have numerous issues. Endoscopes may be difficult to clean because they may be a long length (an enteroscope may be over two meters long), may have one or more very long and very small lumens, and they include a multitude of small, ornate parts constructed from a wide variety of materials that have regions that may shelter microbes. These regions may include regions where parts meet, in cracks and connections, and regions where there are scratches and localized damage. The use of most endoscopes typically requires them to be immersed in pathogen-rich contaminants, including blood, feces, urine, and diseased and infected tissue. Reusable scopes are expected to survive a very large number of cases-often over one thousand-over a long period of time, e.g., several years. However, such long-life expectations create issues: a careful analysis of used scopes shows them to be often damaged both internally and externally. The repair of endoscopes is logistically taxing, requires constant quality-control and inspection, requires expensive back-up devices, shipping, receiving and proper packaging and transport, and is very expensive: a reusable scope typically has lifetime repair costs that exceed the cost of the initial purchase. Because reusable scopes are expected to last for years, it inherently means that clinicians are performing endoscopy with outdated technology. Cleaning scopes also requires considerable capital equipment, as well as their requisite space, training, maintenance, and repair. Successful cleaning of scopes requires the successful execution of highly detailed procedures (often over one hundred separate steps) and often by staff that has significant turnover, is ill-trained, is hurried, is in poor communication with the end-user, and is working without all of the necessary tools. It is well-documented that scope cleaning is not usually performed accurately and completely, as per the full and complete list of cleaning instructions. The complete set of activities necessary to clean and return scopes ready for their next case requires a complicated, time-consuming, multi-person, expensive internal logistics dance as the devices move throughout their various steps in various locations within the hospital, with different tasks being handed-off between a large number of different people and departments. Hospital space is very expensive, and the storage, processing, and movement of these devices creates very real facility costs. Furthermore, the cleaning process often takes the devices out of commission for extended periods of times, requiring that facilities that perform endoscopy maintain a vast arsenal of rotating devices to fulfill their ongoing procedures. Further, despite the impression that re-use is good for the environment, the cleaning of scopes creates a remarkably large amount of landfill—gloves, wipes, brushes, personal protective gear, connectors, tubing, test strips, and hazardous chemicals. The chemical cleaning agents are harsh for the scope, the facility, the environment, and the people performing the cleaning. Importantly, such cleaning processes may clean a scope, but the processed scope is not sterile (the goal is HLD, High Level Disinfection), because many of the scope's materials cannot withstand the rigors of the requisite chemicals, temperatures, or radiation. Sterilization via ethylene oxide would require long exposure and aeration times, is haza