SUCTION VALVE WITH OUTWARDLY BIASED SHAFT FOR AN ENDOSCOPE

Devices, systems, and methods for a suction valve assembly for a medical device. The suction valve assembly includes a valve member with a valve shaft that slides within a valve well. The valve shaft includes one or more slits and is biased to expand outward and press against internal walls of the valve well.

TECHNICAL FIELD

This disclosure relates generally to valve assemblies and methods, and particularly to suction valve assemblies and methods for an endoscope.

BACKGROUND

A wide variety of intracorporeal medical devices and systems have been developed for medical use, for example, for endoscopic procedures. Some of these devices and systems include guidewires, catheters, catheter systems, endoscopic instruments, and the like. These devices and systems are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices, systems, and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices and systems as well as alternative methods for manufacturing and using medical devices and systems.

SUMMARY

This disclosure provides design, material, manufacturing method, and use alternatives for medical devices and medical systems. In a first example, a suction valve assembly for a medical device can comprise a valve body having a cylindrical valve well with internal walls, an inlet channel in fluid communication with the valve well, and an outlet channel in fluid communication with the valve well; and a valve member having a valve shaft, the valve shaft having an inlet opening and positioned within the valve well to slide along the internal walls between a closed position where the inlet opening abuts a portion of the internal walls and an open position where the inlet opening is aligned with the inlet channel of the valve body. The valve shaft can have one or more slits extending through a side surface of the shaft allowing the valve shaft to expand outwards, the valve shaft biased to expand outwards to a diameter greater than an inner diameter defined by the internal walls of the cylindrical valve well.

Alternatively or additionally to any of the examples above, the valve member can include a cap accessible from outside the valve body, the cap in mechanical communication with the valve shaft such that actuating the cap slides the valve shaft into the open position.

Alternatively or additionally to any of the examples above, the valve member can include a neck connecting the valve cap to the valve shaft.

Alternatively or additionally to any of the examples above, the neck can include a flat portion and a rounded portion shaped to resist rotation of the valve member within the valve body.

Alternatively or additionally to any of the examples above, the valve well can extend the length of the longest dimension of the valve body between a top face and an opposing bottom face of the valve body.

Alternatively or additionally to any of the examples above, the inlet channel can be positioned within an internal wall of the valve well.

Alternatively or additionally to any of the examples above, the outlet channel can be positioned within the bottom face of the valve body.

Alternatively or additionally to any of the examples above, the valve shaft can have only one slit extending through a side surface of the shaft allowing the valve shaft to expand outwards.

Alternatively or additionally to any of the examples above, the valve shaft can have slits extending through side surfaces of the shaft allowing the valve shaft to expand outwards.

Alternatively or additionally to any of the examples above, the two slits can be on opposite sides of the valve shaft.

Alternatively or additionally to any of the examples above, the valve member can include a plurality of ribs across the one or more slits within the valve shaft.

Alternatively or additionally to any of the examples above, the valve member can be made of a single piece of uniform material.

Alternatively or additionally to any of the examples above, the suction valve assembly can further include a valve skirt having one or more wedge members, the valve skirt configured such that, when the valve shaft is in the closed position, each of the one or more wedge members presses against one of the one or more slits in the valve shaft to bias the valve shaft outwards towards the internal walls of the valve well.

Alternatively or additionally to any of the examples above, the valve member can be made of polycarbonate plastic.

In another example, an endoscopic surgical device comprises an endoscopic probe, a suction valve assembly according to any of the examples above, and a source of suction in fluid communication with the inlet channel of the suction valve assembly, such that opening the valve provides suction to the endoscopic probe from the inlet channel, through the valve well, and into the outlet channel. The outlet passage of the suction valve assembly is in fluid communication with the endoscopic probe.

In another example, a suction valve assembly can be for use in an endoscope having a lumen configured to extend into a patient's body cavity. The suction valve assembly comprises a valve body having a cylindrical valve well with internal walls, an inlet channel in fluid communication with the valve well, and an outlet channel in fluid communication with the valve well; and a valve member having a valve shaft, the valve shaft having an inlet opening and positioned within the valve well to slide along the internal walls between a closed position where the inlet opening abuts a portion of the internal walls and an open position where the inlet opening is aligned with the inlet channel of the valve body. The valve shaft can have one or more slits extending through a side surface of the shaft allowing the valve shaft to expand outwards, the valve shaft biased to expand outwards to a diameter greater than an inner diameter defined by the internal walls of the cylindrical valve well.

These and other features and advantages of the present disclosure will be readily apparent from the following detailed description, the scope of the claimed invention being set out in the appended claims.

DETAILED DESCRIPTION

This disclosure is now described with reference to an illustrative medical system that may be used in endoscopic medical procedures. However, it should be noted that reference to this particular procedure is provided only for convenience and not intended to limit the disclosure. A person of ordinary skill in the art would recognize that the concepts underlying the disclosed devices and related methods of use may be utilized in any suitable procedure, medical or otherwise. This disclosure may be understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals.

The recitation of numerical ranges by endpoints includes all numbers within that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although some suitable dimensions, ranges, and/or values pertaining to various components, features and/or specifications are disclosed, one of skill in the art, incited by the present disclosure, would understand desired dimensions, ranges, and/or values may deviate from those expressly disclosed.

The detailed description is intended to illustrate but not limit the disclosure. Those skilled in the art will recognize that the various elements described may be arranged in various combinations and configurations without departing from the scope of the disclosure. The detailed description illustrates example embodiments of the disclosure.

With reference toFIG.1, an illustrative endoscope100is depicted andFIG.2depicts an illustrative endoscope system200. The endoscope100may include an elongated tube or shaft100athat is configured to be inserted into a subject (e.g., a patient).

A light source205of the endoscope system200may feed illumination light to a distal portion100bof the endoscope100. The distal portion100bof the endoscope100may house an imager (e.g., CCD or CMOS imager) (not shown). The light source205(e.g., lamp) may be located in a video processing unit210that processes signals input from the imager and outputs processed video signals to a video monitor (not shown) for viewing. The video processing unit210may also serve as a component of an air/water feed circuit by housing a pressurizing pump215, such as an air feed pump, in the unit210.

The endoscope shaft100amay include a distal tip100c(e.g., a distal tip unit) provided at the distal portion100bof the shaft100aand a flexible bending portion105proximal to the distal tip100c. The flexible bending portion105may include an articulation joint (not shown) to assist with steering the distal tip100c. On an end face100dof the distal tip100cof the endoscope100is a gas/lens wash nozzle220for supplying gas to insufflate the interior of the patient at the treatment area and for supplying water to wash a lens covering the imager. An irrigation opening225in the end face100dsupplies irrigation fluid to the treatment area of the patient. Illumination windows (not shown) that convey illumination light to the treatment area, and an opening230to a working channel235extending along the shaft100afor passing tools to the treatment area, may also be included on the face100dof the distal tip100c. The working channel235may extend along the shaft100ato a proximal channel opening110positioned distal to an operating handle115(e.g., a proximal handle) of the endoscope100. A biopsy valve120may be utilized to seal the channel opening110against unwanted fluid egress.

The operating handle115may be provided with knobs125for providing remote 4-way steering of the distal tip via wires connected to the articulation joint in the bendable flexible portion105(e.g., one knob controls up-down steering and another knob control for left-right steering). A plurality of video switches130for remotely operating the video processing unit210may be arranged on a proximal end side of the handle115.

The handle115may be provided with dual valve locations135. One of the valve locations135may receive a gas/water valve140for operating an insufflating gas and lens water feed operation. A gas supply line240aand a lens wash supply line245arun distally from the gas/water valve140along the shaft100aand converge at the distal tip100cproximal to the gas/wash nozzle220(FIG.2).

The other valve location135may receive a suction valve145for operating a suction operation. A suction supply line250amay run distally from the suction valve145along the shaft100ato a junction point in fluid communication with the working channel235of the endoscope100.

The operating handle115may be electrically and fluidly connected to the video processing unit210, via a flexible umbilical260and connector portion265extending therebetween. The flexible umbilical260has a gas (e.g., air or CO2) feed line240b, a lens wash feed line245b, a suction feed line250b, an irrigation feed line255b, a light guide (not shown), and an electrical signal cable (not shown). The connector portion265when plugged into the video processing unit210connects the light source205in the video processing unit with the light guide. The light guide runs along the umbilical260and the length of the endoscope shaft100ato transmit light to the distal tip100cof the endoscope100. The connector portion265when plugged into the video processing unit210also connects the air pump215to the gas feed line240bin the umbilical260.

A water reservoir or container270(e.g., water bottle) may be fluidly connected to the endoscope100through the connector portion265and the umbilical260. A length of gas supply tubing240cpasses from one end positioned in an air gap275between the top280(e.g., bottle cap) of the reservoir270and the remaining water285in the reservoir to a detachable gas/lens wash connection290on the outside of the connector portion265. The gas feed line240bfrom the umbilical260branches in the connector portion265to fluidly communicate with the gas supply tubing240cat the detachable gas/lens wash connection290, as well as the air pump215. A length of lens wash tubing245c, with one end positioned at the bottom of the reservoir270, may pass through the top280of the reservoir270to the same detachable connection290as the gas supply tubing240con the connector portion265. In other embodiments, the connections may be separate and/or separated from each other. The connector portion265may also have a detachable irrigation connection293for irrigation supply tubing (not shown) running from a source of irrigation water (not shown) to the irrigation feed line255bin the umbilical260. In some embodiments, irrigation water is supplied via a pump (e.g., peristaltic pump) from a water source independent (not shown) from the water reservoir270. In other embodiments, the irrigation supply tubing and lens wash tubing245cmay source water from the same reservoir. The connector portion265may also include a detachable suction connection295for suction feed line250band suction supply line250afluidly connecting a vacuum source (e.g., hospital house suction) (not shown) to the umbilical260and endoscope100.

The gas feed line240band lens wash feed line245bmay be fluidly connected to the valve location135for the gas/water valve140and configured such that operation of the gas/water valve in the well controls supply of gas or lens wash to the distal tip100cof the endoscope100. The suction feed line250bis fluidly connected to the valve location135for the suction valve145and configured such that operation of the suction valve145in the well controls suction applied to the working channel235of the endoscope100.

The suction valve145may be configured to allow or prevent suction and/or a suction effect in the working channel235. When the suction valve145is in a valve closed position (e.g., a first configuration), a suction fluid flow through the working channel235may be blocked by the suction valve145. When suction is desired in the working channel235, an operator or user may actuate the suction valve145(e.g., by depressing a button on the valve and/or actuating the suction valve145in one or more other suitable manners) in order to bring the suction valve145to a valve open position (e.g., a second configuration). When the suction valve145is in the valve opened position, a flow channel inside the suction valve may connect the working channel235to the suction device coupled to suction connection295and the suction device may create a negative pressure that draws fluid into and out of the working channel235through an outlet provided in the suction valve. When the operator or user releases the suction valve145, the valve145may return to its valve closed position and reduce or block a suction fluid flow from the working channel235.

In some cases, suction valves145may rely on a path of least resistance to direct suction fluid flow through the endoscope system200. In some cases, when a suction pump is turned on for a procedure, the pump remains on for an entirety of the procedure and continually pulls air from the flexible umbilical260, which in turn draws fluid from the line side of the endoscope100that runs up the umbilicus260and connects to a port at the suction valve145. When the suction valve145is in a first position and/or configuration (e.g., a closed position) the suction force or negative pressure from the suction pump is blocked from the working channel235and may pull fluid from atmosphere through the suction valve145. When the suction valve145is actuated to a second position and/or configuration (e.g., an opened position) (e.g., when the button or cap associated with the suction valve145is depressed and/or actuated in one or more other suitable manners), the opening from atmosphere through the suction valve145to the suction pump may be effectively closed or blocked by the suction valve145and a fluid path between working channel235and the suction pump through the suction valve145may be opened. Thus, fluid moving to the suction pump may follow a path of least resistance, where the path may change depending on whether the suction valve145is in a first position (e.g., a closed position) or a second position (e.g., an opened position)

In some cases, valve stems of suction valves145may be configured to have a close fit with a valve well configured to receive the valve stem in the endoscope100. In such suction valves145, when the valve stem is in a first position the close fit blocks a flow path or increases a resistance to flow between the working channel235and the suction pump and reduces a resistance to flow between atmosphere and the suction pump. Similarly, when the valve stem is in a second position, the close fit blocks a flow path or increases a resistance to flow between the atmosphere and the suction pump and reduces a resistance to flow between the working channel235and the suction pump.

Suction valves145configured to block flow using close fits between the valve stem and valve well requires valves stems that are precisely manufactured. The precision required to produce suction valves with close fits requires expensive materials (e.g., metals, etc.), highly precise machinery, and is time consuming to achieve.

Additionally, suction valves145with close fit valve stems and valve wells are manufactured to have at least some clearance to allow the valve stem to adjust positions within the valve well. This clearance, may result in leakage during use, which may lead to two issues noticeable by a physician. The first is when the suction valve145is in a position intended to block suction from the working channel235, there is still some suction flow passing through the working channel235and the suction valve145to the suction pump. The smaller the clearance between the valve stem and the valve well, the less unwanted flow through the working channel235that occurs and the larger the clearance, the more unwanted flow through the working channel235, however, clearance is needed to facilitate movement of the valve stem within the valve well. When flow is actively moving up the working channel235in such configurations of the suction valve235, users may perceive the suction as “poor insufflation” due to the suction of the suction pump pulling volume from a body lumen in which the user is working, even when the suction valve145is in a position intended to block a suction flow from the working channel235. Second, when a valve stem of the suction valve145is in a position within a valve well to facilitate a suction flow between the working channel235and the suction pump through the suction valve145, the flow from atmosphere to the suction pump may not be completely blocked. Any such leaking from atmosphere may reduce a pressure differential between suction valve and the distal end of the working channel235, which leads to a reduced suction force or negative pressure, reduced flow rates, and aerated flow through the fluid path to the suction pump.

Suction valves145configured to operate with close-fit valve stems and valve wells may work well enough when intended for re-use in multiple procedures, as a price point for such suction valves can be high enough to justify manufacturing the suction valves145from materials and with the necessary precision that can achieve and maintain desired tolerances over the life of the reusable suction valves145. However, a price point of a single use suction valve may not allow for use of the necessary materials, tools, and/or precise manufacturing required to achieve and/or maintain tolerances over the life of single-use suction valves.

The suction valve configurations for endoscopes100and/or other suitable scopes discussed herein address the above-noted concerns with existing suction valves and are configured to mitigate and/or eliminate leakage along an unintended flow path through the suction valve145.FIG.3Adepicts a schematic perspective view of an illustrative suction valve member300configured to address these concerns.

As shown inFIG.3A, the suction valve member300includes a cap302, a valve neck304, and a valve shaft310. The valve shaft310further includes inlet openings312and shaft slits314. In this embodiment of the member300, the shaft300includes two symmetrical slits314located radially opposite each other along the shaft sidewalls.

Although the valve neck may have a fully circular cross-section in alternative embodiments,FIG.3Ashows the valve neck304with alternating flat and curved surfaces that correspond to the shape of an opening in the valve body. This prevents the valve member300from rotating relative to the valve body and assures that the proper passages will be aligned when the valve is open and obstructed when the valve is closed.

In the side view of the member300shown inFIG.3B, it can be seen that the side walls of the shaft310flare at an outward angle when not constrained. This angle may be, for example, less than 5 degrees, and may be the natural result of the valve's manufacture as further described herein. A region of deformation316, at the top of each slit314within the shaft310, may contract to allow movement of the lower part of the shaft310between the flared angle shown inFIG.3Band a substantially parallel angle as shown inFIGS.3C and3D.

FIGS.3C and3Dshow the valve member300interacting with a valve body320in accordance with embodiments of the disclosure. The valve body320includes a valve well322, an inlet passage324, and an outlet passage326. InFIG.3C, the side wall of the valve shaft310blocks the inlet passage324; the valve is closed.

When a user presses on the cap302, the valve member300slides downward within the valve well322until the inlet opening312aligns with the passage324, opening the valve as shown inFIG.3D. The passage324is in fluid communication with a source of suction, resulting in fluid flow in the directions shown in the arrows.

Due to the outward bias in the valve shaft310, the shaft presses against the valve well322in both the open and closed positions. In the closed position, this force helps maintain a seal between the side wall of the shaft310and the inlet passage324, at the region328ashown by the dotted circle inFIG.3C.

The outward bias in the valve shaft310also acts to seal the air channel when the valve is open. The shaft310presses against the wall below the passage324at the region328bshown by the dotted circle inFIG.3D.

Other designs for the valve member are possible, such as those shown inFIGS.4and5. Valve member400has a shaft410with slits414, but with the addition of ribs418. The ribs418provide additional strength to the shaft410and resist inward deformation of the shaft walls. Similarly, the shaft510of the valve member500includes ribs518within the slits514, which, due to an intermediate angle in each rib518, may be more yielding than the ribs418while still providing some additional support.

FIGS.6A-6Cillustrate another embodiment of a valve member600in which the valve shaft610has one slit614rather than two slits. Depending on how much deformation is necessary for a particular valve configuration, any of the two-slit designs described herein could potentially be made with only one slit. In some implementations, the slit may be sized or shaped differently to accommodate the lack of a corresponding slit on the opposite side. Furthermore, while the slits herein have been shown orthogonal to the inlet openings (that is, disposed 90 degrees around the shaft wall relative to the inlet openings), it will be understood that the slits could in fact be located at other relative locations if asymmetric deformation of the shaft is preferred.

FIGS.7A-7Dillustrate an embodiment of a suction valve containing both a valve member700and valve skirt730. The valve skirt730includes a neck opening732sized and shaped to accommodate the valve neck704.

The valve member700includes tapered slits714that are opened at the top of the valve shaft710. Wedges734protruding from the underside of the valve skirt730fit within the tapered slits714when the valve is in the closed position, pushing the sides of the valve shaft710outward.

The valve skirt730and one or more wedges734remain stationary with the valve body720. When the valve member700is positioned to close the valve, as shown inFIG.7C, the one or more wedges734push outward on the valve shaft710, which causes the shaft walls to push against the inlet passage724, creating a seal against suction in the circled region728.

As shown inFIG.7D, when a user presses on the cap702, the valve member700slides downward within the valve well322until the inlet opening712aligns with the passage724allowing for flow into the valve member700. At the same time, the one or more wedges734disengage from the sides of the valve shaft710, allowing the sides of the valve shaft710to relax inward.

The valve member may be manufactured of relatively inexpensive materials suitable for disposal after a single use. The cap, neck, and shaft may be contiguously manufactured from a single piece of polycarbonate plastic; each component may be manufactured from a separate piece of plastic and then attached together. Each of the components of the valve member may, in some implementations, be made of the same or similar materials, with the thickness and dimensions of each piece chosen to provide the necessary resilience and hardness.

In some implementations, the valve shaft may be injection-molded or extruded with one or more of the openings and/or slits not yet present, and then tooling, cutting, or another appropriate technique may be used to remove portions of the shaft in order to form the openings and/or slits. In some implementations, ribs, flanges, wedges, and other smaller features may be cut from the same original piece of material as the surrounding components or may be formed separately (of the same or different material) and then attached as shown.