Patent Description:
Endoscopes are reusable medical devices. An endoscope should be reprocessed, i.e., decontaminated, between medical procedures in which it is used to avoid causing infection or illness in a subject. Endoscopes are difficult to decontaminate as has been documented in various news stories. See, e.g.,<NPL> (last visited Oct. <NUM>, <NUM>). 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. One exemplary disinfectant is CIDEX® OPA Solution, manufactured and distributed by Applicant, Advanced Sterilization Products, Division of Ethicon US, LLC, a Johnson & Johnson company ("ASP").

Endoscope reprocessing may be conducted by a healthcare worker, or with the assistance of machinery, such as an endoscope reprocessor, e.g., ASP's EVOTECH® Endoscope Cleaner and Reprocessor. Patent application <CIT> discloses an endoscope comprising a flexible cleaning tube curled in a loop. A cleaning solution is forcibly refluxed from one end of the cleaning tube to the other end to clean the endoscope. A feed port pipe is configured to provide fluid to the cleaning tube. A single nozzle is provided between an inlet and an outlet of the tube.

The invention relates to an endoscope reprocessor according to claim <NUM>. The endoscope reprocessor includes a basin. The basin includes a drain hole. A tube in a coiled configuration is fluidly coupled to the drain hole. The tube includes an inlet, an outlet, a wall having an outer surface, and a plurality of nozzles. The tube has a curvilinear axis therethrough.

Each nozzle includes an ingress and a base disposed on the outer surface of the tube between the inlet and the outlet. Each nozzle may also include a hose barb disposed proximate to the ingress. Fluid may be delivered into the tube through the nozzle. The nozzle may be oriented in various orientations. For example, in spherical coordinates, the nozzle may be oriented with a first polar angle of between approximately zero degrees and approximately ninety degrees from a first reference line that extends perpendicularly from the curvilinear axis and through the base of the nozzle. The polar angle may be approximately zero degrees. Further, the nozzle may be oriented with a first azimuthal angle of between approximately zero degrees and approximately ninety degrees about the first reference line. The first azimuthal angle may be approximately thirty degrees. The nozzle may be oriented at various other orientations, e.g., the first polar angle may be approximately forty- five degrees and the first azimuthal angle may be approximately forty-five degrees.

The tube may be comprised of various segments connected via connector components. The connector components may include a nozzle. For example, the tube may comprise a first tube segment connected to a second tube segment by a connector component including the nozzle.

Further, the connector component may comprise a hollow-wall structure having an outer connector surface and an inner connector surface including a plurality of ports disposed therethrough. The plurality of ports may each have a central axis that is perpendicular to an egress of the port. A hollow may be disposed between the inner connector surface and the outer connector surface such that fluid may be provided into the tube along a fluid path including the ingress of the nozzle, the hollow, and the port. At least one of the plurality of ports may be oriented such that a second polar angle between the central axis of that port and a second reference line that is perpendicular to the curvilinear axis and passes through the port is between about zero degrees and about forty-five degrees.

The invention also relates to a method of using an endoscope reprocessor that includes such a tube. An insertion tube of an endoscope, likely in a contaminated state, is inserted through the tube. Fluid, e.g., a disinfectant, is delivered through the nozzle while the same or a different fluid may be delivered through the tube's inlet. The insertion tube may be floated within the tube by forces exerted by the fluid flowing through the nozzles. The fluid may be provided through the nozzles at a varying flow rate. Thus, the insertion tube may be moved in response to changing forces depending on the flow rate of the fluid. The insertion tube may be removed from the endoscope reprocessor in a disinfected state.

Further modifications to an endoscope reprocessor are disclosed herein. A bracket may be disposed in a basin. The bracket may include an inlet and a plurality of jets, e.g., between two and ten, e.g., three, directed toward one or more focal points. The bracket may be connected to a manifold having a plurality of outlets, e.g., two, three, four, or five. The manifold may be connected to a source of disinfectant fluid. The bracket may also include a clamp. An endoscope may be disposed within the endoscope reprocessor, with the tip of the insertion tube supported by the clamp. The endoscope may include an elevator at the distal end of the elevator channel, i.e., within the tip of the insertion tube. The tip and the elevator may be positioned at the focal point or points, supported by the clamp.

A wire frame may also be provided in the endoscope reprocessor. The bracket and manifold may be attached to the wire frame.

As used herein, the term "curvilinear axis" may be understood to indicate a longitudinal axis of an object that has been configured to have a curved shape. Specifically, a straight tube that has a longitudinal axis may be configured into a coiled shape such that the longitudinal axis becomes a curvilinear axis.

As used herein, the terms "polar angle" and "azimuthal angle" may be understood to indicate polar and azimuthal angles of a spherical-coordinate system.

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 first reference numerals identify the same elements and in which:.

The following detailed description should be read with first reference to the drawings, in which like elements in different drawings are identically numbered.

<FIG> reflects an endoscope <NUM> disposed within a basin <NUM> of an endoscope reprocessor <NUM>. Basin <NUM> includes a drain hole <NUM>. Insertion tube <NUM> of endoscope <NUM> exits basin <NUM> via drain hole <NUM>.

<FIG> reflects endoscope reprocessor <NUM>, which contains at least one coiled tube <NUM> (i.e., a tube in a coiled configuration), further detailed in <FIG>. Tube <NUM> includes an inlet <NUM> fluidly coupled to drain hole <NUM> and an outlet <NUM> fluidly coupled to a pump <NUM>. Tube <NUM> further includes a wall with an inner surface and an outer surface. Because inlet <NUM> is coupled to drain hole <NUM>, and insertion tube <NUM> exits basin <NUM> via drain hole <NUM>, insertion tube <NUM> thus extends through the inside of coiled tube <NUM> and rests against the coiled tube's inner surface.

Thus, fluid, e.g., a disinfectant, such as CIDEX® OPA Solution, introduced or within basin <NUM> may flow out of drain hole <NUM> and through tube <NUM> to pump <NUM>. Pump <NUM> may be fluidly coupled to basin <NUM> such that any fluid it receives may be pumped back up to basin <NUM> and reintroduced therein. Accordingly, during operation of endoscope reprocessor <NUM>, the fluid may be continuously recirculated from basin <NUM>, through tube <NUM>, out of outlet <NUM>, into pump <NUM>, and back up to basin <NUM>. The fluid is thus in continuous contact with insertion tube <NUM>, which assists in disinfecting it.

Disinfectant processes are typically associated with a microbial reductions of <NUM>-<NUM> (Log <NUM>), as compared to washing (e.g., with soap and water) or sterilization, which are typically associated with microbial reductions of <NUM>-<NUM> (Log <NUM>) and <NUM>-<NUM> (Log <NUM>) respectively. Tube <NUM> includes along its length, between its inlet <NUM> and outlet <NUM>, a plurality of nozzles <NUM>, which may be useful for increasing the effectiveness of a disinfection process conducted by endoscope reprocessor <NUM>.

The description also discloses an embodiment wherein the tube possesses a nozzle <NUM>.

With further reference to Ligure <NUM>, nozzle <NUM> includes an ingress <NUM>, and a base <NUM> disposed on the outer surface of tube <NUM>. Nozzle <NUM> is hollow and provides a path from ingress <NUM> to the inside of tube <NUM>. As shown, nozzle <NUM> is provided on a tubing connector component <NUM> that can connect a first segment <NUM> of tube <NUM> to a second segment <NUM> of tube <NUM>. Connector component <NUM> may be fabricated from any suitable process, e.g., injection molding, machining, or 3D printing.

Tubing segments <NUM> and <NUM> may be connected to connector component <NUM> by, e.g., a friction fit, snap fit, or press fit connection. Moreover, tube segments <NUM> and <NUM> may be rotated circumferentially relative to connector component <NUM> before or after connection thereto, which may assist in creating coiled tubing of irregular (e.g., non-helical) shapes. Alternatively, the nozzle may be positioned circumferentially with respect to the segments, which may provide various other advantages. For example, if tubing <NUM> is provided in a helical configuration, e.g., with four connector components, the nozzles may be oriented relative to each other at <NUM> degrees, <NUM> degrees, <NUM> degrees, and <NUM> degrees. The connections to connector component <NUM> should be fluid tight to avoid leakage. Accordingly, it may be desired to bond segments <NUM> and <NUM> to connector <NUM> using, e.g., a sealant, solvent, or adhesive.

Fluid may be introduced into coiled tube <NUM> via nozzles <NUM> in addition to inlet <NUM>. For example, pump <NUM>, a different pump, or both, may fluidly connect a source of fluid to ingresses <NUM> of nozzles <NUM> and pump the fluid therethrough. To assist in any such connections, nozzle <NUM> may include a tubing connector, e.g., hose barb <NUM>, proximate to ingress <NUM>.

Introduction of fluid through nozzles <NUM> adds energy to the fluid already flowing within tube <NUM>. This energy may increase vorticity, turbulence, and shear stresses in the flow, which may assist in removing microorganisms or other bioburdens from insertion tube <NUM>. Nozzles <NUM> may each have the same, similar, or different orientations relative to tube <NUM>. Further, nozzles <NUM> may be oriented at any angle with respect to tube <NUM>.

Exemplary orientations are provided in spherical coordinates relative to a reference line that is perpendicular to a curvilinear axis of tube <NUM> and passes through base <NUM> of nozzle <NUM>. Nozzle <NUM> may be provided in various orientations relative to tube <NUM>. For example, as shown in <FIG> and <FIG>, nozzle <NUM> may be oriented such that its polar angle to the reference line is between about thirty and forty-five degrees and its azimuthal angle about that reference line is between about thirty and forty-five degrees. In this orientation, fluid introduced through nozzle <NUM> may impart a helical flow component around insertion tube <NUM>, aided in part by the arcuate or circular shape of connector <NUM>'s inner surface as well as tube <NUM>'s inner surface. Helical flow around insertion tube <NUM> may be accomplished by orienting nozzle <NUM> over a wide range of polar and azimuthal angles. Depending on various factors, e.g., the diameter of insertion tube <NUM>, the diameter of coiled tube <NUM>, and removal of bioburdens besides microbes, optimal angles of nozzle <NUM> may vary. However, it should be understood that the polar angle of nozzle <NUM> may range from approximately zero to approximately ninety degrees and that the azimuthal angle may also range from approximately zero to approximately ninety degrees. In those instances where the polar angle is between about zero degrees and fifteen degrees from the reference line, fluid introduced through nozzles <NUM> may impinge directly upon insertion tube <NUM>, which may also assist in removal of bioburdens therefrom. However, there may be a tradeoff between local improvement of cleaning close to the site of impingement and the amount of energy imparted into the fluid for cleaning locations away from the site of impingement.

In typical usage, fluid from basin <NUM> flows through drain hole <NUM> at a flow rate of between approximately fifteen liters per minute and approximately twenty-five liters per minute. Thus, fluid flows through tube <NUM> at approximately the same rate. The volume flow rate through each nozzle <NUM> may be between approximately <NUM> liters per minute and approximately <NUM> liters per minute. Further, the flow rate through nozzles <NUM> may be varied, which results in changing the amount of energy carried by fluid introduced therethrough. For example, flow through the nozzles may be cycled on and off. Alternatively, the flow rate may be varied back and forth continuously between two volume flow rates, e.g., between about <NUM> liters per minute and about <NUM> liters per minute over a period of time lasting anywhere between, e.g., about one second and about ten seconds. By changing the flow rate as a function of time in this manner, insertion tube <NUM> may be agitated within tube <NUM>, which may further assist in removing bioburden therefrom.

<FIG> reflects a connector <NUM>, which includes a nozzle <NUM> having a polar angle of about zero degrees and an azimuthal angle of about ninety degrees. Connector <NUM> may comprise a hollow-wall structure <NUM>. That is, connector <NUM> may include an outer connector surface <NUM> and an inner connector surface <NUM> that define a hollow therebetween. Further, a plurality of ports <NUM> may be disposed through inner connector surface <NUM> such that they provide fluid communication from the hollow of connector <NUM>. Accordingly, fluid that enters connector <NUM> through nozzle <NUM> flows through the hollow and exits out of ports <NUM>.

The plurality of ports <NUM> may be provided in various configurations, e.g., spaced circumferentially about the inner surface. At least one of the ports may be oriented such that a polar angle between, first, a second reference line that passes through the port and is perpendicular to a longitudinal axis of connector <NUM> or the curvilinear axis of tube <NUM> when connected thereto and, second, a central axis of the port (i.e., a longitudinal axis or an axis that is perpendicular an egress of the port) is between about zero degrees and about forty-five degrees. Thus, flow through the ports may enter connector <NUM> either transversely to curvilinear axis of tube <NUM>, or with a component of the flow parallel to the curvilinear axis. As with connector <NUM>, introduction of fluid into tube <NUM> through ports <NUM> adds energy to the fluid already flowing within tube <NUM>. This energy may increase vorticity, turbulence, and shear stresses in the flow, which may assist in removing microorganisms or other bioburdens from insertion tube <NUM>. Further, in those embodiments where ports <NUM> are disposed along the bottom of connector <NUM>, e.g., only along the bottom of connector <NUM>, the fluid exiting ports <NUM> may cause insertion tube <NUM> to float within tube <NUM> which may improve flow around the entire surface of insertion tube <NUM> and thus assist in removing bioburden therefrom.

Further improvements may be made to an endoscope reprocessor that are particularly suitable for cleaning an endoscope that has an insertion tube <NUM> including an elevator and an elevator channel. The elevator and the portion of the elevator channel proximate thereto are difficult to clean and disinfect. <FIG> reflect a bracket <NUM> that is hollow and includes an inlet <NUM> and a plurality of outlets or jets <NUM>. It may further optionally include a clamp <NUM>. Bracket <NUM> may be disposed on wire frame <NUM>, which may be disposed within a basin of an endoscope reprocessor.

Also disposed on wireframe <NUM> is a manifold <NUM>. As shown, manifold <NUM> includes five outlets. Outlet <NUM> connects to inlet <NUM> on bracket <NUM>. The remaining four outlets <NUM>, <NUM>, <NUM>, and <NUM>, may each be connected to channels of the endoscope. Disinfectant may thus be delivered from the manifold and through the various outlets and tubing connected thereto to the channels of the endoscope and to bracket <NUM>. The disinfectant that reaches bracket <NUM> may be projected forcefully out of jets <NUM>. As reflected in the figures, jets <NUM> are each directed to a focal point centered therebetween. The tip <NUM> of the insertion tube <NUM>, which includes the elevator, may be positioned at that point and may be supported proximate thereto by clamp <NUM>. Thus, jets <NUM> may forcefully spray tip <NUM> and the elevator from multiple directions, which assists in removing bioburden therefrom.

As noted, manifold <NUM> includes five outlets. This manifold is thus designed to be used for disinfecting an endoscope with four channels including an elevator channel. Thus, outlets <NUM>, <NUM>, <NUM>, and <NUM> are connected to these channels. However, in instances where an endoscope with less than four channels to be disinfected will be reprocessed in the reprocessor, a different manifold with an appropriate number of outlets may be used instead of manifold <NUM>. Manifold <NUM> may assist a user by reducing the overall number of connections that need to be made between a supply of disinfectant and the endoscope's channels.

Claim 1:
An endoscope reprocessor (<NUM>), comprising:
a basin (<NUM>) including a drain hole (<NUM>);
a tube (<NUM>) in a coiled configuration fluidly coupled to the drain hole (<NUM>), the tube (<NUM>) having a curvilinear axis, an inlet (<NUM>), an outlet (<NUM>), a wall including an outer surface, and a plurality of nozzles (<NUM>) along the length of the tube (<NUM>), each nozzle (<NUM>) having an ingress (<NUM>) and a base (<NUM>) disposed on the outer surface between the inlet and the outlet such that a fluid may be delivered into the tube (<NUM>) through the nozzles (<NUM>).