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EP-3768142-B1 - DISPOSABLE VALVE FOR AN ENDOSCOPE OPTIONALLY HAVING A LUBRICANT AND/OR AN ANTIMICROBIAL AGENT

EP3768142B1EP 3768142 B1EP3768142 B1EP 3768142B1EP-3768142-B1

Inventors

  • LAGOW, Robert
  • SCHREINER, JOHN
  • HEMINK, DAVID C.

Dates

Publication Date
20260506
Application Date
20190319

Claims (11)

  1. A disposable valve assembly (100) configured for use with an endoscope, the disposable valve assembly comprising: a stem (101) comprising a proximal end (135) and a distal end and a first opening (142) disposed along a longitudinal axis of the stem and extending from the proximal end to the distal end of the stem, the stem comprising a thermoplastic material and a second opening transverse to and intersecting with the first opening, the second opening of the stem extending at least partially through the stem; a spring stanchion (200) comprising an opening configured to receive the stem, the spring stanchion and/or a spring configured to allow movement of the stem in an upward and downward direction relative to the spring stanchion; and the spring configured to contact the spring stanchion; a cap (102) configured to engage the proximal end of the stem; and a duckbill valve (182) disposed at the distal end of the stem.
  2. The disposable valve assembly of claim 1, wherein the disposable valve assembly is used to control the flow of air and water to the endoscope.
  3. The disposable valve assembly of claim 1, wherein the second opening of the stem is adjacent to the distal end of the stem and extends through the stem.
  4. The disposable valve assembly of claim 1, wherein the disposable valve assembly is used to allow suction through the endoscope.
  5. The disposable valve assembly according to the preceding claims, wherein the cap has a fitting to snap fit with the stem.
  6. The disposable valve assembly of claim 1, wherein the disposable valve assembly further comprises a boot having a diameter greater than the spring stanchion and configured to engage the spring stanchion.
  7. The disposable valve assembly of claim 4, wherein the stem comprises a surface opposite the second opening comprising a projection extending from the stem, the projection having a semicircular shape for aligning the disposable valve assembly with the endoscope.
  8. The disposable valve assembly of claim 4, wherein the second opening of the stem partially extending through the stem further comprises a gasket contiguous with the second opening and having a protrusion.
  9. The disposable valve assembly of claim 5, wherein the cap comprises a plurality of projections configured to receive a stem insert at one end and to snap fit onto the stem at the opposite end.
  10. The disposable valve assembly of claim 4, further comprising (i) a plurality of gaskets disposed at the distal end of the stem; or (ii) dual gaskets disposed at the distal end of the stem.
  11. The disposable valve assembly according to the preceding claims, wherein (i) the thermoplastic material comprises an antimicrobial agent; and/or (ii) the thermoplastic material has an antimicrobial agent coated thereon.

Description

BACKGROUND Health care organizations are continually under pressure to find ways to lower or limit health care costs. One such opportunity for health care organizations to reduce costs is by recycling materials and supplies, in particular, by recovering single use medical devices (SUDs) that can be cleaned and sterilized for reuse. Typically, medical devices fall into two categories. The first category is reusable devices, which are sold as reusable and can be cleaned and sterilized for reuse by a health care organization, such as a hospital. Reusable, manufacturer designated multiple-use medical devices are sold with the expectation that the medical devices can and will be processed for reuse by hospitals or surgery centers. Such medical devices are sold once and are typically cleaned and resterilized many times for use on multiple patients. These medical devices are collected after use by hospital or surgery center personnel and are cleaned, resterilized in an autoclave or by exposure to ethylene oxide or other appropriate sterilant, repackaged as necessary, and then reused. The second category involves reprocessable devices, which are designated by the manufacturer for single use only; these medical devices can be reused only if properly reprocessed. Among medical devices, endoscopes are well-known in the art and are commonly used for numerous medical procedures. A control section of an endoscope may include a suction cylinder, air/water cylinder, biopsy channels, and the like. Valves may be inserted into these cylinders or channels to control various functions of the endoscope. After each use, an endoscope will undergo cleaning, disinfection, sterilization, and the like to prevent the spread of disease, germs, bacteria, and illness. Many components of an endoscope may be reusable, including valves which regulate the flow of air, water, or suction of fluids through the endoscope, and which must also be cleaned, disinfected, and/or sterilized between uses. Unfortunately, there is usually a great expense associated with maintaining a high level of disinfection of the equipment and the reusable valves. Reusable endoscope valves must be carefully tracked together with the corresponding endoscope during cleaning and reprocessing procedures to identify breaches in reprocessing of the endoscope and its corresponding valves, which reduces the risk of cross-contamination among patients when endoscopes and their corresponding valves are reused. Reusable valves may be assembled from the combination of several metal, plastic, and/or rubber components. As such, there are significant costs associated with the manufacturing of reusable valves for use with endoscopes. Disposable valves eliminate the need for cleaning, disinfection, and sterilization of reusable valves, thereby eliminating the cost of repeated cleaning, disinfection, and sterilization. Disposable valves also eliminate the need to track valves to a specific endoscope model and serial number and provide the highest level of infection prevention to the patient. Additionally, disposable valves do not require expensive materials to be utilized in manufacture, thereby eliminating the high cost of manufacturing valves from expensive materials. Relevant prior art, disclosing endoscope valves is disclosed for example in US 2013/303844 and US 2015/144215. Thus, there is a need to develop new disposable valves for use with endoscopes that reduce or eliminate cross contamination and the need for repeated cleaning, disinfection, and sterilization. In particular, there is a need for new valves and methods that have the ability of preventing or substantially eliminating the growth of bacteria, fungi and the like during the endoscopic procedure. SUMMARY The invention pertains to a disposable valve assembly configured for use with an endoscope, the disposable valve assembly comprising: a stem comprising a proximal end and a distal end and a first opening disposed along a longitudinal axis of the stem and extending from the proximal end to the distal end of the stem, the stem comprising a thermoplastic material and a second opening transverse to and intersecting with the first opening, the second opening of the stem extending at least partially through the stem;a spring stanchion comprising an opening configured to receive the stem, the spring stanchion and/or a spring configured to allow movement of the stem in an upward and downward direction relative to the proximal and/or distal end;and the spring configured to contact the spring stanchion;a cap configured to engage the proximal end of the stem;and a duckbill valve disposed at the distal end of the stem. The invention is defined in the following claims. Other embodiments, items, examples, modifications etc. are not a part of the invention and are disclosed for illustrative purposes only. BRIEF DESCRIPTION OF THE DRAWINGS In part, other aspects, features, benefits and advantages of the embodiments will be apparent with