Patent Application
20230397799
The subject matter disclosed herein relates to a leakage test connector and, more specifically, a leakage test connector comprising a male connector assembly and female connector assembly, used for testing leakage in endoscopes.
Endoscopes are reusable medical devices generally used in minimally invasive procedures. Endoscopes are flexible instruments, which are costly, complex and fragile instruments. After use, the endoscope can be reprocessed, i.e., decontaminated, to avoid causing infection or illness in a subject.
Typically, endoscope reprocessing is performed by a disinfection procedure that includes at least the following steps: removing foreign material from the endoscope, cleaning the endoscope, and disinfecting the endoscope by, among other things, submerging it in a disinfectant capable of substantially killing microorganisms thereon, e.g., infection causing bacteria. Endoscope reprocessing may be conducted by a healthcare worker or with the assistance of machinery, such as an Endoscope Cleaner and Reprocessor (ECR), e.g., the EVOTECH® Cleaner and Reprocessor manufactured by Advanced Sterilization Products, Inc. of Irvine, California.
Endoscopes are often leak tested prior to reprocessing to ensure that cleaning and disinfecting liquids do no penetrate into areas of endoscopes that can damage the endoscopes. Such leak tests may assist in: 1) confirming the presence and proper body connection to an endoscope; 2) assessing whether the endoscope body has a leak rate beyond the ability of the system to maintain sufficient body pressure in assuring subsequent processing can be performed without moisture ingress; 3) checking the endoscope body pressure and its structural integrity; and 4) stabilizing the endoscope scope body pressure during the entire cycle. The EVOTECH® Cleaner and Reprocessor, for example, includes a leakage test subsystem comprising a leakage connector extending into its endoscope basin.
If any leaks are found, the leakage test subsystem will give an alarm and the cycle will stop. If no leaks are found, the endoscope body is pressurized and once the pressure is stabilized, a vent valve is opened to decay the pressure. When the pressure in the endoscope is increased and the initial stabilization pressure exceeds a certain pressure, the vent valve is opened to reduce the stabilization pressure. The leakage test subsystem makes sure that this pressure is maintained throughout the entire cycle.
According to ISO 15883-1, leakage test subsystems in automated disinfectors are to include a leakage connector that cannot be connected to the typically male connectors of endoscope channels, e.g., the air and water channels. Thus, leakage connectors often also comprise male connectors.
A leakage test connector may comprise a male connector having an outer circumferential surface, a female socket connector that mates to the male connector, and an O-ring mounted about an inner circumferential surface of the fluid passage of the female socket connector. The male connector lacks an O-ring on the outer circumferential surface in an unmated state with the female socket connector. Upon mating the male connector to the female socket connector, the O-ring of the female connector contacts the outer circumferential surface of the male connector. The male connector may also comprise a valve actuator pin, while the female socket connector comprises a pin that depresses the valve actuator pin. The valve actuator pin includes a top surface that is disposed flush with a tip of the male connector.
While the specification concludes with claims, which particularly point out and distinctly claim the subject matter described herein, it is believed the subject matter will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which:
The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.
As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, “about” or “approximately” may refer to the range of values ±10% of the recited value, e.g. “about 90%” may refer to the range of values from 81% to 99%. In addition, as used herein, the terms “patient,” “host,” “user,” and “subject” refer to any human or animal subject and are not intended to limit the systems or methods to human use, although use of the subject invention in a human patient represents a preferred embodiment.
The subject matter disclosed herein relates to a leakage test connector and, more specifically, a leakage test connector for testing leakage in endoscopes. The leakage test connector includes a male leakage test connector with a valve actuator pin used to actuate an internal valve. A top surface of the valve actuator pin is flush with a tip of male leakage test connector and is designed to move up and down to either close the internal valve or actuate (open) the internal valve, respectively. This actuator pin, being flush with a tip of male leakage test connector, reduces any exposed surfaces and, hence, eliminates or reduces the likelihood of contamination on male leakage connector. More specifically, valve actuator pin will avoid or at least minimize liquid present on male connector, which could otherwise end up inside the internal endoscope body during leakage testing.
In addition, the leakage test connector lacks an O-ring groove or O-ring on its outer circumference; instead, an O-ring is installed in a groove on an inner circumference of an off-the-shelf and disposable female socket connector. In this way, when the O-ring degrades, a new female connector may be obtained with a new O-ring to replace the older female connector with the worn O-ring. In those endoscope processors where an O-ring is disposed on the outside of the male leakage connector, when the O-ring becomes worn, a technician must typically be called to replace the O-ring. This O-ring, along with other O-rings in the endoscope reprocessor, can also be color coded to identify the connection types as illustrated in Table 1 below (which are non-limiting, illustrative examples).
Referring more specifically to
Male leakage test connector 200 comprises a housing 202. Housing 202 may include a threaded portion 204 and a flange 208 to assist in connecting male leakage test connector 200 to a basin of an endoscope reprocessor. At least one securing feature, e.g., nut 206, may be engaged with threaded portion 204 for the same purpose. Nuts 206 may be positioned on an inner surface of the basin and flange 208 may be positioned on an outer, exposed surface of the basin. The flange 208 will prevent housing 202 from completely passing through opening of the basin, in addition to assisting in securing housing 202 to the basin. For example, by fastening or tightening nut(s) 206, male leakage test connector 200, e.g., housing 202, will be secured to the basin with assistance of flange 208 contacting the interior surface of the basin. As shown in
Male leakage test connector 200 further includes a male connector portion 210 comprising a valve actuator pin 214. A top surface (e.g., tip) 215 of valve actuator pin 214 sits flush to a top surface (e.g., tip) 216 of male connector portion 210 (see, e.g.,
As valve actuator pin 214 is flush with top surface 216 of male connector portion 210, it will not be prone to accumulation of water or contamination on a surface thereof. That is, valve actuator pin 214 will not have an exposed surface extending from male connector portion 210 which would otherwise accumulate water or contamination on its surface. This is in contrast to conventional valve actuators that extend beyond a tip of the male connector, allowing accumulation of water or contaminants to sit on an exposed surface of the valve actuator.
In addition, male connector portion 210 is devoid of any O-ring or seal member on its outer surface. Instead, as shown in
Male connector portion 210 further includes a recessed portion 212 on male connector portion 210, adjacent to flange 208. The recessed portion 212 includes a lip 213. The male connector portion 210 mates with fluid channel 304 of female socket connector 300 by a connect/disconnect mechanism 306 engaging with recessed portion 212. For example, connect/disconnect mechanism 306 can comprise a quick release mechanism which engages with recessed portion 212 such that quick release mechanism 306 will engage and lock female socket connector 300 to male connector portion 210, with lip 213 of recessed portion 212 preventing disengagement or movement of female socket connector 300. The quick release mechanism 306 can be controlled by tab 308 extending from an exterior surface of female connector portion 304.
As shown in
In the locked position, pin 302 will also depress and open valve actuator pin 214 creating a fluid passage between male connector portion 210 and fluid channel 304 of female socket connector 300. This fluid passage will extend through coupling 205 of male leakage test connector 200 and hose 400, as well as coupler 314 and hose assembly 500 connected to female socket connector 300. Coupler 314 can a ribbed coupler, hydraulic coupler, etc. As should be understood by those of skill in the art, hose 400 will couple to and provide a fluid passage from male leakage test connector 200 to a pump system of a leakage test apparatus; whereas, hose 500 will provide a fluid passage to an endoscope. In this locked position, O-ring 310 will also engage with exterior, circumferential surface of male connector portion 210, providing a fluid tight connection between male leakage test connector 200 and female socket connector 300.
To disengage female socket connector 300, a user depresses tab 308 of female socket connector 300 to disengage connect/disconnect mechanism 306 from recessed portion 212 of male connector portion 210. This is followed by sliding female socket connector 300 away from male connector portion 210.
A fluid channel (e.g., hollow interior portion) 224 is created between an inner, circumferential surface 227 of male connector portion 210 and the plurality of legs or ribs 217 (as shown more clearly in
Upon activation, e.g., by depression of the valve actuator pin 214 by pin 302 of female socket connector 300, valve actuator pin 214 will be depressed, compressing spring 220, allowing fluid passage within fluid channel 224 to exit male connector and flow into fluid channel 304 of female socket connector 300. Upon removal of female socket connector 300 from male connector portion 210, pin 302 will disengage from valve actuator pin 214 and spring 220 will force valve actuator pin 214 upwards to its closed or resting position, e.g., flush with top surface 216. The depression and upward movement of valve actuator pin 214 is depicted by double arrow in
By virtue of the embodiments illustrated and described herein, methods and variations thereof are implemented using leakage test connector 100. By way of example, after male leakage test connector 200 is fixedly attached to basin 600 of an endoscope reprocessor, e.g., EVOTECH® Cleaner and Reprocessor, as representatively shown in
Any of the examples or embodiments described herein may include various other features in addition to or in lieu of those described above. The teachings, expressions, embodiments, examples, etc., escribed herein should not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined should be clear to those skilled in the art in view of the teachings herein.
Having shown and described exemplary embodiments of the subject matter contained herein, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications without departing from the scope of the claims. In addition, where methods and steps described above indicate certain events occurring in certain order, it is intended that certain steps do not have to be performed in the order described but in any order as long as the steps allow the embodiments to function for their intended purposes. Therefore, to the extent there are variations of the invention, which are within the spirit of the disclosure or equivalent to the inventions found in the claims, it is the intent that this patent will cover those variations as well. Some such modifications should be apparent to those skilled in the art. For instance, the examples, embodiments, geometrics, materials, dimensions, ratios, steps, and the like discussed above are illustrative. Accordingly, the claims should not be limited to the specific details of structure and operation set forth in the written description and drawings.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2021/060367 | 11/9/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63112075 | Nov 2020 | US |
