Valve and valve part for an endoscope

Abstract

Devices, systems, and methods are provided for valves for medical devices. The valve may include a valve stem. The elongated body of the valve stem may include a first opening and a second opening fluidly coupled to each other via a cavity. The valve stem may include a first seal and a second seal extending circumferentially around the elongate shaft. The elongate body, the first seal, and the second seal may be formed of a single material. The single material may be a thermoplastic elastomer or other suitable material. The valve stem may include a recessed portion proximate to the seal of the valve stem to facilitate flexing or flexing of the seal as the valve stem translates within a valve well.

Description

Cross - Reference to Related Applications

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 415,711, filed on October 13, 2022, the disclosure of which is incorporated herein by reference. Technical Field

[0002] The present invention generally relates to valve assemblies and methods, and particularly to valve stems, seals, and methods for endoscopes. Background Art

[0003] A variety of in-vivo medical devices and systems have been developed for medical use, e.g., endoscopic surgery. Some of these devices and systems include guide wires, catheters, catheter systems, endoscopic instruments, etc. These devices and systems are manufactured by any of a variety of different manufacturing methods and can be used according to any of a variety of methods. Each of the known medical devices, systems, and methods has certain advantages and disadvantages. There is a current need to provide alternative medical devices and systems and alternative methods for manufacturing and using medical devices and systems. Summary of the Invention

[0004] The present invention provides alternative designs, materials, manufacturing methods, and uses for medical devices and medical systems. In a first example, a valve stem for a medical device can include an elongate body, a first opening in the elongate body, a second opening in the elongate body, a cavity extending from the first opening to the second opening, a first seal circumferentially extending around the elongate body at a position proximal to the first opening, a second seal circumferentially extending around the elongate body at a position distal to the first opening, and wherein the elongate body, the first seal, and the second seal can be formed from a single material.

[0005] Alternatively or additionally to any of the above examples, the elongate body, the first seal, and the second seal can be integral.

[0006] Alternatively or additionally to any of the above examples, the valve stem can further include a third seal circumferentially extending around the elongate body at a position distal to the second seal, and the third seal can be formed from the single material used to form the elongate body, the first seal, and the second seal.

[0007] Alternatively or additionally to any of the above examples, the valve stem can further include a first recess circumferentially extending around the elongate body at a first axial position, and a second recess circumferentially extending around the elongate body at a second axial position spaced apart from the first axial position, and the first seal can extend from the first recess to the second recess.

[0008] Alternatively or additionally, for any of the above examples, the single material can be a thermoplastic elastomer.

[0009] Alternatively or additionally, for any of the above examples, the wall thickness of the elongate body between the outer surface of the cavity and the elongate body at an axial position between the first seal and the second seal can be in the range of 1.00 mm to 2.00 mm.

[0010] Alternatively or additionally, for any of the above examples, the wall thickness of the elongate body between the outer surface of the cavity and the elongate body at an axial position between the first seal and the second seal can be at least 1.50 mm.

[0011] Alternatively or additionally, for any of the above examples, the single material can have a hardness in the range of 50 Shore A to 75 Shore A.

[0012] Alternatively or additionally, for any of the above examples, the first opening is a radial opening and the second opening is an axial opening in the distal end of the elongate body.

[0013] Alternatively or additionally, for any of the above examples, the engagement portion can extend proximally from the elongate body.

[0014] In another example, a valve stem for a medical device, wherein the valve stem is configured to translate within a valve well of a medical device, the valve stem can include an elongate body formed of a single material, a first opening in the elongate body, a second opening in the elongate body, a cavity extending from the first opening to the second opening, wherein the elongate body can include a first position having a first outer diameter and a second position having a second outer diameter, the first position configured to be spaced apart from the inner wall of the valve well, the second position configured to engage the inner wall of the valve well, and wherein the second position of the elongate body can extend circumferentially around the elongate body.

[0015] Alternatively or additionally, for any of the above examples, most of the length of the elongate body can have a first outer diameter.

[0016] Alternatively or additionally, for any of the above examples, the wall thickness of the elongate body at the second position can be at least 1.50 mm.

[0017] Alternatively or additionally, for any of the above examples, the single material can have a hardness in the range of 50 Shore A to 75 Shore A.

[0018] Alternatively or additionally, for any of the above examples, the elongate body may have a third position and a fourth position longitudinally spaced from the third position, the third position and the fourth position having a third outer diameter, the third outer diameter being less than the first outer diameter, and the second position being located between the third position and the fourth position.

[0019] Alternatively or additionally, for any of the above examples, the elongate body may include one or more positions having a third outer diameter less than the first outer diameter; a first region including a portion having a second outer diameter, the portion having the second outer diameter being located between two positions each having the third outer diameter; and a second region including a portion having the second outer diameter, the portion having the second outer diameter being located between two positions each having the third outer diameter.

[0020] Alternatively or additionally, for any of the above examples, the first region may be proximal to the first opening and the second region is distal to the first opening.

[0021] Alternatively or additionally, for any of the above examples, the elongate body may include a third region including a portion having a second outer diameter, the portion having the second outer diameter being located between two positions each having the third outer diameter, and the first region may be proximal to the first opening, the second region may be distal to the first opening, and the third region may be distal to the second region.

[0022] In another example, a suction valve stem for an endoscope having a suction valve well may include an elongate body, a first opening in the elongate body, a second opening in the elongate body, a lumen extending from the first opening to the second opening, and a seal circumferentially extending around the elongate body at a position proximal to the first opening, and wherein the elongate body and the seal may be formed of the same polymeric material having a hardness in the range of 50 Shore A to 75 Shore A.

[0023] Alternatively or additionally, for any of the above examples, the suction valve stem may further include a first recess circumferentially extending around the elongate body and a second recess circumferentially extending around the elongate body, and wherein the seal may extend from the first recess to the second recess.

[0024] These and other features and advantages of the present invention will become apparent from the following detailed description, and the scope of the claimed invention is set forth in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The drawings, which are incorporated in and constitute a part of this specification, illustrate various embodiments and, together with the description, serve to explain the principles of the invention.

[0026] Figure 1A schematic diagram depicting components of an illustrative endoscope;

[0027] Figure 2 A schematic diagram depicting components of an illustrative endoscope system;

[0028] Figure 3 A schematic perspective view depicting an illustrative valve stem;

[0029] Figure 4 Depicts Figure 3 A schematic cross-sectional view of the illustrative valve stem depicted in

[0030] Figure 5 Depicts Figure 3 A schematic cross-sectional view of the illustrative valve stem depicted in , where the valve stem is in a valve well;

[0031] Figure 6 A schematic perspective view depicting an illustrative valve stem;

[0032] Figure 7 Depicts Figure 6 A schematic cross-sectional view of the illustrative valve stem depicted in ; and

[0033] Figure 8A And Figure 8B Depicts Figure 6 A magnified schematic cross-sectional view of the valve stem depicted in and positioned within a valve well.

[0034] While the present invention is susceptible to various modifications and alternative forms, specific details thereof have been shown by way of example in the drawings and will be described in more detail. However, it should be understood that the present invention is not intended to limit the aspects of the present invention to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present invention. Detailed Description

[0035] The present invention will now be described with reference to an illustrative medical system that can be used in endoscopic medical procedures. However, it should be noted that the reference to this specific procedure is provided for convenience only and is not intended to limit the present invention. Those of ordinary skill in the art will recognize that the concepts upon which the disclosed apparatus and related methods of use are based can be used in any suitable procedure, medical aspect, or other aspect. The present invention can be understood by reference to the following description and the drawings, in which like elements are referred to by like reference numerals.

[0036] All numerical values in this document are assumed to be modified by the term "about" whether or not explicitly indicated. In the context of numerical values, the term "about" generally refers to a range of numbers that a person skilled in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the term "about" may include numbers that are rounded to the nearest significant digit. Unless otherwise specified, other uses of the term "about" (e.g., in contexts other than numerical values) may be assumed to have their ordinary and customary definitions as understood in the context of this specification and consistent therewith.

[0037] Recitation of a numerical range 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 for various components, characteristics, and / or specifications are disclosed, those skilled in the art to which this invention pertains will understand that desired dimensions, ranges, and / or values can be derived from those expressly disclosed.

[0038] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and / or" unless the context clearly dictates otherwise. It should be noted that, for ease of understanding, certain features of the invention may be described in the singular, even though those features may be plural or repeated in the disclosed embodiments. Each instance of a feature may include and / or incorporate the singular disclosure unless expressly stated to the contrary. For simplicity and clarity, not all elements of the invention will necessarily be shown in each figure or discussed in detail below. However, it should be understood that the following discussion may equally apply to any and / or all of the components where there is more than one, unless expressly stated to the contrary. Additionally, for clarity, in some instances all elements or features may not be shown in each figure.

[0039] It should be noted that references to "one embodiment", "some embodiments", "other embodiments", etc. indicate that the described embodiments may include specific features, structures, or characteristics, but each embodiment may not necessarily include that specific feature, structure, or characteristic. Moreover, these phrases do not necessarily refer to the same embodiment. Additionally, when a specific feature, structure, or characteristic is described in connection with an embodiment, using the specific feature, structure, or characteristic in connection with other embodiments is within the knowledge of those skilled in the art, whether explicitly described or not, unless explicitly stated to the contrary. That is, the various individual elements described below, even if not explicitly shown in a particular combination, can still be considered combinable or arranged with each other to form other additional embodiments, or to supplement and / or enrich the described embodiments, as will be understood by those of ordinary skill in the art.

[0040] For clarity, throughout the specification and / or claims, a certain identificatory numeral nomenclature (e.g., first, second, third, fourth, etc.) may be used to name and / or distinguish various described and / or claimed features. It should be understood that the numeral nomenclature is not intended to be limiting and is merely illustrative. In some embodiments, for the sake of brevity and clarity, the previously used numeral nomenclature may be changed and deviated from. That is, a feature identified as a "first" element may later be referred to as a "second" element, a "third" element, etc., or may be omitted entirely, and / or different features may be referred to as the "first" element. The meaning and / or name in each case will be apparent to those skilled in the art.

[0041] The detailed description is intended to illustrate, not limit, the present invention. Those skilled in the art will recognize that the various elements described can be arranged in various combinations and configurations without departing from the scope of the present invention. The detailed description illustrates example embodiments of the present invention.

[0042] Reference Figure 1 depicts illustrative endoscope 100, and Figure 2 depicts illustrative endoscope system 200. Endoscope 100 may include an elongate tube or shaft 100a configured to be inserted into a subject (e.g., a patient) body.

[0043] The light source 205 of the endoscope system 200 can deliver illumination light to the distal portion 100b of the endoscope 100. The distal portion 100b of the endoscope 100 can accommodate an imager (e.g., a CCD or CMOS imager) (not shown). The light source 205 (e.g., a lamp) can be located in the video processing unit 210, which processes signals input from the imager and outputs the processed video signal to a video monitor (not shown) for viewing. The video processing unit 210 can also serve as a component of the gas supply loop / water supply loop by housing a pressurizing pump 215, such as a gas supply pump, in the unit 210.

[0044] The endoscope shaft 100a can include a distal tip 100c (e.g., a distal tip unit) provided at the distal portion 100b of the shaft 100a, and a flexible bending portion 105 proximal to the distal tip 100c. The flexible bending portion 105 can include a hinge joint (not shown) to assist in steering the distal tip 100c. On the end face 100d of the distal tip 100c of the endoscope 100 is a gas / lens cleaning nozzle 220, which is used to supply gas for insufflation inside the patient in the treatment area and to supply water for cleaning the lens covering the imager. A lavage opening 225 in the end face 100d supplies lavage fluid to the treatment area of the patient. A lighting window (not shown) for transmitting illumination light to the treatment area and an opening 230 to a working channel 235 can also be included on the face 100d of the distal tip 100c. The working channel 235 extends along the shaft 100a for delivering tools to the treatment area. The working channel 235 can extend along the shaft 100a to a proximal channel opening 110 located distal to the operating handle 115 (e.g., the proximal handle) of the endoscope 100. A biopsy valve 120 can be utilized to seal the channel opening 110 to prevent unwanted fluid outflow.

[0045] The operating handle 115 can be provided with knobs 125 for providing remote four-way steering of the distal tip (e.g., one knob controls up and down steering, and the other knob controls left and right steering) via wires connected to the hinge joints in the flexible bending portion 105. A plurality of video switches 130 for remotely operating the video processing unit 210 can be arranged on the proximal side of the handle 115.

[0046] The handle 115 can be provided with a dual-valve position 135. One of the valve positions 135 can have or receive a gas / water valve 140 for operating the insufflation gas and lens water supply operations. A gas supply line 240a and a lens cleaning supply line 245a extend distally along the shaft 100a from the gas / water valve 140 and converge at the distal tip 100c proximal to the gas / cleaning nozzle 220, as Figure 2 depicted.

[0047] Another valve position 135 may have or receive a suction valve 145 for suction operations. A suction supply line 250a may extend distally from the suction valve 145 along the shaft 100a to a junction point in fluid communication with the working channel 235 of the endoscope 100.

[0048] The operating handle 115 may be electrically and fluidly connected to the video processing unit 210 via a flexible umbilical tube 260 and a connector portion 265 extending therebetween. The flexible umbilical tube 260 has a gas (e.g., air or CO2) supply line 240b, a lens cleaning supply line 245b, a suction supply line 250b, an irrigation supply line 255b, an optical guide (not shown), and an electrical signal cable (not shown). The connector portion 265 connects the light source 205 in the video processing unit to the optical guide when inserted into the video processing unit 210. The optical guide extends along the length of the umbilical tube 260 and the endoscope shaft 100a to transmit light to the distal tip 100c of the endoscope 100. The connector portion 265 also connects the air pump 215 to the gas supply line 240b in the umbilical tube 260 when inserted into the video processing unit 210.

[0049] A water reservoir or container 270 (e.g., a water bottle and / or other suitable reservoir or container) can be fluidly connected to the endoscope 100 via a connector portion 265 and an umbilical tube 260. A length of gas supply tubing 240c extends from one end in an air gap 275 positioned between the top 280 (e.g., the bottle cap) of the reservoir 270 and the remaining water 285 in the reservoir to a detachable gas / lens cleaning connector 290 outside the connector portion 265. The gas supply line 240b from the umbilical tube 260 branches in the connector portion 265 to fluidly communicate with the gas supply tubing 240c at the detachable gas / lens cleaning connector 290 and the gas pump 215. When the gas supply tubing 240c is on the connector portion 265, a length of lens cleaning tubing 245c with one end positioned at the bottom of the reservoir 270 can pass through the top 280 of the reservoir to the same detachable connector 290. In other embodiments, the connections can be separate and / or detached from each other. The connector portion 265 can also have a detachable irrigation connector 293 for an irrigation supply tubing (not shown) that extends from an irrigation water source (not shown) to the irrigation supply line 255b in the umbilical tube 260. In some embodiments, irrigation water can be supplied from a water source (not shown) independent of the water reservoir 270 via a pump (e.g., a peristaltic pump). In other embodiments, the irrigation supply tubing and the lens cleaning tubing 245c can obtain water from the same reservoir. The connector portion 265 can also include a detachable suction connector 295 for fluidly connecting a vacuum source (e.g., hospital house suction) (not shown) to the suction supply line 250b and the suction supply line 250a of the umbilical tube 260 and the endoscope 100.

[0050] The gas supply line 240b and the lens cleaning supply line 245b can be fluidly connected to a valve position 135 of the gas / water valve 140 and are configured such that operation of the gas / water valve 140 in the well controls the supply of gas or lens cleaning fluid to the distal tip 100c of the endoscope 100. The suction supply line 250b is fluidly connected to a valve position 135 of the suction valve 145 and is configured such that operation of the suction valve 145 in the well controls the suction applied to the working channel 235 of the endoscope 100.

[0051] Reference Figure 2, an illustrative operation of an endoscope system 200 including an endoscope, such as endoscope 100 described above, is explained. Air from the air pump 215 in the video processing unit 210 can flow through the connection portion 265 and branch through the gas supply line 240b in the umbilical tube 260 to the air / water valve 140 on the operating handle 115, and reach the water reservoir 270 via the connector 290 on the connector portion 265 through the gas supply pipe 240c. When the air / water valve 140 is in the neutral position, without the user placing a finger on the valve, air is allowed to flow out of the valve 140 to the atmosphere. In the first position, the user's finger is used to block the vent to the atmosphere. Gas is allowed to flow downward along the gas supply line 240a from the valve 140 and out of the distal tip 100c of the endoscope 100, for example, to insufflate a treatment area of a patient. When the air / water valve 140 is depressed to the second position, gas is prevented from flowing out of the valve 140, allowing the pressure of the air passing through from the air pump 215 to rise in the water reservoir 270. Pressurizing the water source forces water to come out of the lens cleaning pipe 245c, through the connector portion 265, the umbilical tube 265, through the air / water valve 140 and along the lens cleaning supply line 245a, thus converging with the gas supply line 240a before leaving the distal tip 100c of the endoscope 100 via the gas / lens cleaning nozzle 220. The air pump pressure can be calibrated to provide lens cleaning water at a relatively low flow rate compared to the supply of irrigation water.

[0052] The magnitude of the flow rate of lens cleaning is determined by the gas pressure in the water reservoir 270. When the gas pressure in the water reservoir 270 starts to drop, as water is pushed out of the reservoir 270 through the lens cleaning pipe 245c, the air pump 215 supplies air to replace the air lost in the reservoir 270 to maintain a substantially constant pressure, which in turn provides a substantially constant lens cleaning flow rate. In some embodiments, a filter (not shown) can be placed in the path of the gas supply pipe 240c to filter out undesirable contaminants or particles so that they do not enter the water reservoir 270. In some embodiments, an outflow check valve or other one-way valve configuration (not shown) can be placed in the path of the lens cleaning supply pipe to help prevent water from flowing back into the reservoir 270 after passing through the valve.

[0053] Irrigation water typically requires a relatively high flow rate compared to lens cleaning because the primary use is to remove debris that obstructs the user's view in the treatment area within the patient's body. Irrigation is typically achieved using a pump (e.g., a peristaltic pump) as described. In a configuration having a separate water source for irrigation, the piping placed at the bottom of the water source can pass through the top of the water source and through the head on the upstream side of the pump. The piping 255c on the downstream side of the pump is connected via an irrigation connector 293 on the connector portion 265 to the irrigation supply line 255b in the umbilical tube 260 and the irrigation supply line 255a of the endoscope 100. When irrigation water is needed, the fluid is pumped out of the water source by operating the irrigation pump, such as depressing a foot switch (not shown), and flows through the irrigation connector 293, through the irrigation supply line 255b in the umbilical tube 260, and along the irrigation supply line in the shaft 100a of the endoscope 100 to the distal tip 100c. To balance the pressure in the water source when water is pumped out of the irrigation supply piping, a vent (not shown) can be included in the top 280 of the water reservoir 270. The vent allows atmospheric air to enter the water source, thereby preventing the accumulation of negative pressure in the water source, which could create a vacuum that draws unwanted substances within the patient's body back towards the water source through the endoscope. In some configurations, a configuration similar to the outflow check valve or other one-way valve of the lens cleaning piping 245c (not shown) can be placed in the path of the irrigation supply piping to help prevent backflow into the reservoir after the water passes through the valve.

[0054] The aspiration valve 145 can be configured to allow or block aspiration and / or aspiration effects in the working channel 235. When the aspiration valve 145 is in the valve closed position (e.g., the first configuration), the aspiration fluid flow through the working channel 235 may be blocked by the aspiration valve 145. When aspiration is needed in the working channel 235, the operator or user can actuate the aspiration valve 145 (e.g., by pressing a button on the valve and / or actuating the aspiration valve 145 in one or more other suitable ways) to bring the aspiration valve 145 to the valve open position (e.g., the second configuration). When the aspiration valve 145 is in the valve open position, the flow channel inside the aspiration valve can connect the working channel 235 to an aspiration device that is coupled to the aspiration connector 295, and the aspiration device can create a negative pressure that draws fluid into and out of the working channel 235 through an outlet provided in the aspiration valve. When the operator or user releases the aspiration valve 145, the valve 145 can return to its valve closed position and reduce or block the aspiration fluid flow from the working channel 235.

[0055] In some cases, the aspiration valve 145 can rely on the path of least resistance to direct aspirated fluid flow through the endoscopic system 200. In some cases, when the aspiration pump is turned on for a procedure, the pump remains on throughout the procedure and continuously draws air out of the flexible umbilical tube 260, which in turn draws fluid into the endoscopic 100 from the line side of the port that extends upward along the umbilical tube 260 and connects to the aspiration valve 145. When the aspiration valve 145 is in a first position and / or configuration (e.g., a closed position), the suction force or negative pressure from the aspiration pump is blocked outside the working channel 235, and fluid can be drawn from the atmosphere through the aspiration valve 145. When the aspiration valve 145 is actuated to a second position and / or configuration (e.g., an open position) (e.g., when a button or cap associated with the aspiration valve 145 is pressed and / or actuated in one or more other suitable ways), the opening from the atmosphere through the aspiration valve 145 to the aspiration pump can be effectively closed or blocked by the aspiration valve 145, and the fluid path through the aspiration valve 145 between the working channel 235 and the aspiration pump can be opened. Thus, the fluid moving toward the aspiration pump can follow the path of least resistance, where the path can change depending on whether the aspiration valve 145 is in the first position (e.g., closed position) or the second position (e.g., open position).

[0056] In some cases, the valve stem of the air / water valve 140 and / or the aspiration valve 145 can be configured to have a tight fit with a valve well that is configured to receive the valve stem within the endoscope 100. In such air / water valves 140 and aspiration valves 145, when the valve stem is in a first position (e.g., a closed position), the tight fit blocks the flow path or increases the flow resistance between the working channel 235 of the endoscopic system 200 and the fluid lines (e.g., the gas supply line 240b, the lens cleaning supply line 245b, the aspiration supply line 250b). Similarly, when the valve stem is in a second position, the tight fit opens the flow path and reduces the flow resistance between the working channel 235 and the fluid lines.

[0057] The lens cleaning valve 140 and / or the aspiration valve 145, which are configured to use a tight fit between the valve stem and the valve well to block flow, require a precisely manufactured valve stem. The precision required to produce an aspiration valve with a tight fit requires expensive materials (e.g., metals, etc.), highly precise machines, and takes a significant amount of time to achieve.

[0058] Additionally, valves with a tightly fitting valve stem and valve well are manufactured with at least some clearance to allow the valve stem to adjust its position within the valve well. This clearance can cause leakage during use, which can lead to at least two problems that may be noticed by the physician.

[0059] The first problem is that when the valve is in a position intended to block the flow from the working channel 235, there is still some flow through the working channel 235. The smaller the clearance between the valve stem and the valve well, the less unwanted flow through the working channel 235 occurs, and the larger the clearance, the more unwanted flow through the working channel 235. However, a clearance is still needed to facilitate the movement of the valve stem within the valve well. When flow actively moves through the working channel 235 in this configuration of the valve, even when the valve is in a position intended to block the flow from the working channel 235, the user may perceive the aspiration as "poor insufflation" and / or experience leakage at the distal end of the endoscope shaft 100a.

[0060] The second problem is that when the valve stem of the valve is in a position within the valve well to facilitate flow between the working channel 235 and the fluid line, the desired flow may be insufficient or weaker than desired or expected because the fluid escapes from its intended path through the clearance. In one example, when the valve stem of the aspiration valve 145 is configured to have a tight fit with the valve well and is in a position within the valve well to facilitate aspiration flow through the aspiration valve 145 between the working channel 235 and the aspiration pump, the flow from the atmosphere to the aspiration pump may not be completely blocked. Any such leakage from the atmosphere can reduce the pressure differential between the aspiration valve 145 and the distal end of the working channel 235, which can result in a reduced aspiration force or negative pressure, a reduced flow rate, and an inflation flow through the flow path to the aspiration pump.

[0061] When intended for repeated use in multiple procedures, a valve configured to operate with a tightly fitting valve stem and valve well can work well enough because the price point of such a valve may be high enough to justify manufacturing the valve with materials and with the necessary precision to achieve and maintain the required tolerances within the service life of the reusable valve. However, the price point of a single-use valve may not allow the use of the necessary materials, tools, and / or precise manufacturing to achieve and / or maintain tolerances within the service life of a single-use aspiration valve.

[0062] In some cases, a compliant seal can be applied to the central shaft to form a valve stem configured to close the flow path through the valve in the endoscope. The compliant seal can be applied to the central shaft as a discrete component and / or can be applied to the central shaft by insert molding or overmolding onto the central shaft. However, due to high volume and / or other factors, it can be challenging to maintain quality when assembling discrete seals onto the central shaft. While applying the seal to the central shaft via insert molding or overmolding may be more efficient than assembling discrete seals onto the central shaft, insert molding or overmolding may require specific equipment to apply the seal to the central shaft.

[0063] The valve configurations discussed herein for endoscope 100 and / or other suitable scopes address the above problems of existing valves and are configured to mitigate and / or eliminate leakage through the valve. Regarding Figures 3 to 8B The valve configurations discussed can include a valve stem integrally formed with one or more seals or other sealing features. Such a valve stem can be formed from a single material on a standard injection molding machine and / or using one or more other suitable processes.

[0064] Figure 3 A perspective view of an illustrative valve stem 300 for use in endoscope 100 (e.g., a medical device assembly) is depicted. Although Figure 3 the valve stem 300 described in can be configured for use in the suction valve 145, the valve stem 300 can also be configured for use in the air / water valve 140 and / or other suitable valves that include characteristics and / or properties similar to those of the suction valve 145 and / or the air / water valve 140, but have seals and / or openings at different locations and configured for a particular use (e.g., where the seals and / or openings can be configured and / or positioned to be adjustably aligned with the opening of the valve well).

[0065] The valve stem 300 can have any suitable configuration that is configured to adjust its position within the valve well and / or adjustably fluidly couple the working channel 235 of the endoscope system 200 with a fluid line. In one example, the valve stem 300 can be elongate and can include one or more openings and one or more cavities extending between the one or more openings.

[0066] Figure 3 The valve stem 300 described in can include an elongate body 302. The elongate body 302 can include a first portion 302a and a second portion 302b. The first portion 302a of the elongate body 302 can be an engagement portion that is configured to be actuated to adjust the position of the valve stem 300 within the valve well. In some cases, the first portion 302a can be configured to couple with a button or cap for the valve, and a user can interact with the button or cap to adjust the position of the valve stem 300 within the valve well, but this is not required. Example suitable coupling mechanisms for connecting the first portion 302a with the button or cap can include, but are not limited to, adhesives, threaded connections, luer lock connections, snap connections, ball-ratchet connectors, friction fits, and / or additional or alternative coupling mechanisms. The first portion 302a of the elongate body 302 can also include one or more "keying" features that are configured to engage keying features of the valve well to enable the valve stem 300 to be oriented within the valve well. The second portion 302b of the elongate body 302 can be configured to be positioned within the valve well and can include features for facilitating fluid flow between the working channel 235 of the endoscope system 200 and the fluid line, and / or for blocking fluid flow between the working channel 235 and the fluid line.

[0067] The valve stem 300 may include one or more openings in the elongate body 302. In one example, as Figure 3 depicted, the valve stem 300 may include a first opening 304 in the elongate body 302, a second opening 306 in the elongate body 302, and a third opening 308 in the elongate body 302, although other suitable configurations are also conceivable. In some cases, one or more of the openings in the valve stem 300 may be radial or side openings, and one or more of the openings may be axial or end openings. In Figure 3 the depicted example, the first opening 304 and the second opening 306 may be radial openings located at the same first axial position along the longitudinal axis of the elongate body 302, and the third opening 308 may be an axial opening located at a second axial position along the longitudinal axis of the elongate body 302, the second axial position being distal to the first axial position.

[0068] The valve stem 300 may include one or more cavities that extend between one or more of the openings of the valve stem 300. As Figure 3 depicted, the cavity 310 may extend between the third opening 308 and the first opening 304 and the second opening 306. Other suitable configurations of the cavity 310 and / or the openings 304, 306, 308 are conceivable that facilitate adjusting the flow path through the valve based on the position of the valve stem 300 relative to the valve well.

[0069] The valve stem 300 may include one or more seals that are configured to translate with the valve stem 300 within the valve well. The seals of the valve stem 300 may be configured around the elongate body 302 in any suitable manner to interact (e.g., contact) with and / or maintain contact with the inner wall or walls of the valve well in which the valve stem 300 is configured to adjust its position to create a barrier to fluid flow. Illustratively, the seal may extend circumferentially around at least a portion of the elongate body 302 of the valve stem 300 and may extend radially outward from the outer surface 312 of the elongate body 302. As Figure 3 depicted, the valve stem 300 may include a first seal 314, a second seal 316, and a third seal 318, where the first seal 314 may be located proximal to the first opening 304 and the second opening 306, the second seal 316 may be located distal to the first opening 304 and the second opening 306, and the third seal 318 may be located distal to the second seal. Other configurations of the seals of the valve stem 300 are conceivable.

[0070] When compared to a conventional valve stem configured to create a friction fit with the inner wall or surface of the valve well, and particularly when compared to a reusable valve stem, the valve stem 300 utilizing one or more seals can be configured to have increased clearance within the valve well. For example, a conventional valve stem can be configured to have a clearance within the valve well of less than about 0.002 inches, such as a clearance of about 0.002 to about 0.0005 inches, whereas the elongate body 302 of the valve stem 300 of the present invention can have a circumferential clearance of at least about 0.005 inches between the outer surface 312 between the seals and the inner wall of the valve well. In one example, the elongate body 302 of the valve stem 300 can be sized (e.g., configured) to have a clearance of about 0.005 inches to about 0.010 inches between the outer surface 312 and the inner wall of the valve well. The ability to form the valve stem 300 to have a greater clearance within the valve well as compared to conventional valve configurations facilitates the creation of the valve stem 300 using manufacturing techniques that are less precise than those conventionally used for endoscopic aspiration valves and / or materials having more variable tolerances. Other suitable clearances and / or dimensions are contemplated.

[0071] In additional and / or alternative configurations, discrete seals can be omitted from the valve stem 300. In such cases, the outer surface 312 of the elongate body 302 can have a diameter configured to allow the outer surface 312 to engage the inner wall of the valve well in which the valve stem 300 is positioned. When so configured, the outer surface 312 of the elongate body 302 can act as a seal such that axial adjustment of the valve stem 300 within the valve well can adjust the fluid flow through the valve. In some cases, with respect to the amount of resistance generated by a configuration of the valve stem 300 in which the outer surface 312 engages the inner wall of the valve well as a seal, the use of discrete seals on the valve stem 300 (e.g., as depicted in Figure 3 can reduce the resistance of the valve stem 300 when translating within the valve well.

[0072] Figure 4 depicts Figure 3 a cross-sectional view of the valve stem 300 depicted in Figure 5 is Figure 4 a schematic cross-sectional view of the valve stem 300 depicted in

[0073] and at least partially positioned within the valve well 320, which is also shown in cross-section. W The valve well 320 can have an inner wall 321 with an inner diameter of D

[0074] The inner diameter D of the inner surface or wall 321 of the valve well 320 W can be any suitable size. In one example, the inner diameter D of the inner wall 321 W can be a size within the range of 5.50 millimeters (mm) - 8.50 mm, but this is not required, and other suitable sizes for the inner diameter D W are conceivable.

[0075] As Figure 4 depicted, the valve stem 300 can be integrally formed from a single material such that the elongate body 302 and the seals (e.g., the first seal 314, the second seal 316, and the third seal 318) can be integral and / or integrally formed. When integrally formed, the elongate body 302 can include and / or define the seals, but this is not required.

[0076] The single material can be formed from one or more base materials. When the single material is formed from two or more base materials (e.g., two or more polymers, etc.), the two or more base materials are mixed together to form the single material such that all or substantially all parts of the valve stem formed from the single material have the same or similar material composition.

[0077] All or at least a portion (e.g., the second portion 302b) of the elongate body 302 can be formed from the same single material as the first seal 314, the second seal 316, and the third seal 318 such that the elongate body 302, the first seal 314, the second seal 316, and the third seal 218 can be integral. In some cases, the valve stem 300 can be formed by a single injection molding process, but other suitable processes for forming the elongate body 302 are also conceivable.

[0078] The valve stem 300 and / or its components formed from a single material can be formed to have any suitable material hardness. In some cases, the valve stem 300 and / or its components can be formed from any suitable material having a hardness within the range of about 20 - 80 Shore A, about 30 - 60 Shore A, about 50 - 75 Shore A, and / or other suitable values within one or more other suitable hardness ranges, but can also be softer or firmer depending on the geometry of the valve stem 300 and / or its components and the inner wall of the valve well.

[0079] The valve stem 300 and / or its components formed of a single material can be formed of any suitable material. Examples of suitable materials for a single material include, but are not limited to, polymers, thermoplastic elastomers (TPE), thermoplastic polyurethanes (TPU), liquid silicone rubbers (LSR), and / or other suitable materials. In one example, the single material can be TPE, which is a mixture of a thermoplastic and an elastic polymer that exhibits the qualities of two polymer types. In a further example, the single material can be TPE, which has a hardness in the range of 50 Shore A to 75 Shore A. Using TPE as the single material to form the valve stem 300 can facilitate the manufacture of the valve stem 300 because TPE can be processed and formed in a standard molding machine (e.g., a single-shot injection molding machine, etc.), while other materials (e.g., liquid silicone rubber, etc.) may require specialized molding equipment to form the valve stem 300.

[0080] In some cases, one or more portions of the valve stem 300 can be configured to have various predetermined diameters and thicknesses of the elongate body 302, as Figure 4 and Figure 5 depicted. In some cases, the diameter of the valve stem 300 can depend on the inner diameter of the valve well in which the valve stem 300 is intended to translate and / or the configuration and / or can be configured based on and / or can be based on one or more other suitable factors.

[0081] In some examples, the second portion 302b of the elongate body 302 can include the diameter D of the cavity 310 L , and can have one or more regions with a first or major diameter D1, and one or more regions with a second or minor diameter D2, where the minor diameter D2 is greater than the first diameter D1. In one example, the major diameter D1 can be the diameter of the outer surface 312 of the elongate body 302 (e.g., at the axial position between the first seal 314 and the second seal 316, and / or at one or more other suitable axial positions), and the minor diameter D2 can be the diameter of the radially outermost points of the first, second, and third seals 314, 316, and 318 (e.g., the valve stem 300 can have three regions with the minor diameter D2, where at least one sealing region 330 is proximal to the first opening 304, and at least one region 330 is distal to the first opening 304 (see, for example, Figure 6 the sealing regions 330 marked therein)), where the major diameter D1 and the minor diameter D2 can extend circumferentially completely or at least partially around the elongate body 302 and / or other suitable portions of the valve stem 300. Although not required, most of the length of the elongate body 302 can have the major outer diameter D1.

[0082] The diameter D of the cavity 310 Lcan have any suitable dimensions. In some cases, the diameter D of the cavity 310 L should not be a blockage point in the fluid path and can thus be sized to at least the diameter of the largest cavity of the working channel 235 of the endoscope 100. In one example, the cavity 310 can have a diameter D of 3.80 mm or greater L , but this is not required and other suitable diameters can be envisioned.

[0083] The second portion 302b of the elongate body 302 can have a wall thickness T of any suitable dimension. The size of the wall thickness can be determined based at least in part on the type of material used to form the elongate body 302 and / or one or more other suitable factors. In some cases, the wall thickness T at the second portion 302b of the elongate body 302 can be sized to accommodate the diameter D of the cavity 310 L , while allowing the second portion 302b of the elongate body 302 to fit within and translate within the valve well 320 without buckling. In some examples, the wall thickness T can be at least 1.00 mm (in the range of 1.00 mm to 2.00 mm), at least 1.50 mm (in the range of 1.50 mm to 2.00 mm), and / or one or more other suitable dimensions.

[0084] The major diameter D1 of the valve stem 300 or the elongate body 302 can be any suitable distance. In some cases, the major diameter D1 can be determined based at least in part on the type of material used to form the elongate body 302 and be as large as possible relative to the diameter of the inner wall 321 of the valve well 320 in order to maintain the column strength of the valve stem 300 and prevent the elongate body 302 from buckling while allowing the valve stem 300 to move within the valve well 320. When the valve stem 300 includes one or more discrete seals (e.g., the first, second, and third seals 314, 316, 318), the major diameter D1 can be sized to be spaced apart from the inner wall 321 of the valve well 320 and provide space for the seals to bend or flex when engaging the inner wall 321. In some cases, the major diameter D1 can have a dimension in the range between D L + 2*T min and D w + 0.30 mm, where D L is the diameter of the cavity 310, T min is the minimum acceptable wall thickness T, and D w is the inner diameter of the inner wall 321 of the valve well 320. For example, the major diameter D1 can be in the range of approximately 5.80 millimeters (mm) to approximately 8.80 mm. Other suitable dimensions and / or configurations of the major diameter D1 of the valve stem 300 can be envisioned.

[0085] The secondary diameter D2 of the valve stem 300 can be any suitable distance. In some cases, the secondary diameter D2 can be greater than the primary diameter D1 of the inner wall 321 of the valve well 320 and / or the diameter D w , such that the valve stem 300 (e.g., the elongate body 302 of the valve stem 300) can include a location having the secondary diameter D2 that is configured to engage or fluid seal against the inner wall 321 of the valve well 320. In one example, the secondary diameter D2 can be configured to be 0.10 mm to 0.30 mm larger than the diameter of the inner wall 321 of the valve well 320 to ensure that the seal maintains contact with the inner wall 321 and folds or bends sufficiently in response to engagement with the inner wall 321 of the valve well 320 when the valve stem 300 translates within the valve well 320. In another example, when the diameter of the inner wall 321 of the valve well 320 is about 7.00 mm, the primary diameter can be about 6.80 mm, and the secondary diameter D2 can be in the range of 7.10 mm to 7.30 mm. Other suitable configurations of the secondary diameter D2 can be envisioned.

[0086] Figures 6 to 8B A schematic diagram depicting a configuration of the valve stem 300 having one or more recesses 328a, 328b adjacent to a seal (e.g., the first seal 314, the second seal 316, the third seal 318, etc.). Figure 6 A schematic diagram of the valve stem 300 having a first recess 328a and a second recess 328b adjacent to the first, second, and third seals 314, 318, 316, respectively, where the first recess 328a and the second recess 328b extend circumferentially around the elongate body 302.

[0087] As Figure 6 depicted, each seal of the valve stem 300 in combination with adjacent or neighboring recesses 328a, 328b can form a seal area 330. The use of the recesses 328a, 328b can facilitate the axial movement of the valve stem 300 with less force than if the recesses 328a, 328b were not included (e.g., omitted) because the recesses 328a, 328b can allow the seal surfaces (e.g., the seals 314, 316, 318) to deflect, and the deflection of the seal surfaces reduces the resistance on the inner wall 321 of the valve well 320 when the valve stem 300 translates within the valve well 320.

[0088] Figure 7 is Figure 6 A schematic cross-sectional view of the configuration of the valve stem 300 depicted in, which includes three seal areas 330 having recesses 328a, 328b, where the first seal area 330 is proximal to the first opening 304, the second seal area 330 is distal to the first opening 304, and the third seal area 330 can be distal to the second seal area 330. AsFigure 7 As depicted in, the seal(s) (e.g., first seal 314, second seal 316, and / or third seal 318) of the sealed region 330 can extend from the first recess 328a to the second recess 328b, but this is not necessary.

[0089] The recesses 328a, 328b can have any suitable size and / or shape. In some examples, the recesses 328a, 328b can have a cross-section that has a U-shape, V-shape, stepped shape, and / or other suitable shape.

[0090] The third diameter D3 of the valve stem 300 or the elongate body 302 can be located at the recesses 328a, 328b and can be any suitable distance sufficient to allow the seals 314, 316, 318 to flex or bend to facilitate translation of the valve stem 300 within the valve well. The third diameter D3 can be located at the axial position of the recesses 328a, 328b having the smallest diameter, at the axial position of the recesses 328a, 328b where the two surfaces of the recesses 328a, 328b merge, or at another suitable position. In one example, the third diameter D3 of the valve stem 300 located at the recesses 328a, 328b can be 1.00 mm to 3.00 mm smaller than the major diameter D1. In one example configuration, the major diameter D1 of the valve stem 300 can be about 6.90 mm, the minor diameter D2 of the valve stem 300 can be about 7.10 mm, the smallest diameter D3 of the valve stem 300 can be about 6.80 mm, and the diameter of the inner wall 321 of the valve well 320 can be about 7.00 mm.

[0091] The grooves 328a, 328b can have any suitable width and / or angle from the outer surface 312 of the valve stem 300 to the smallest diameter D3 of the valve stem 300 located at the recesses 328a, 328b, which helps the seals to bend and flex in response to engagement with the inner wall 321 of the valve well 320.

[0092] As discussed, the recesses 328a, 328b can facilitate translation of the valve stem 300 within the valve well by providing space adjacent to the seals 314, 316, 318 for the seals 314, 316, 318 to move in response to engagement of the seals 314, 316, 318 with the inner wall 321 of the valve well 320. Additionally, since the recesses 328a, 328b are positions of reduced diameter that facilitate movement of the seals 314, 316, 318 when the valve stem 300 translates within the valve well, the major diameter D1 and the wall thickness T at the major diameter D1 can be increased to a size closer to the size of the minor diameter D2 than would be acceptable without the recesses 328a, 328b, which increases the overall column strength of the valve stem 300 and facilitates the use of TPE and / or other materials suitable for the elongate body 302.

[0093] Figure 8A and Figure 8B depicts Figure 6 an enlarged, schematic cross-sectional view of the valve stem 300 depicted in Figure 6 at its sealing region 330 within the valve well 320. Figure 8A depicts the valve stem 300 translating proximally in the direction of arrow A1 relative to the valve well 320, wherein the second seal 316 (e.g., a seal located distally of the second opening 306 or at one or more other suitable locations) folds or bends into the recess 328b in response to engagement with the inner wall 321 of the valve well 320. Figure 8B depicts the valve stem 300 translating distally in the direction of arrow A2 relative to the valve well 320, wherein the second seal 316 folds or bends into the first recess 328a in response to engagement with the inner wall 321 of the valve well 320.

[0094] As Figure 8A and Figure 8B shown, the recesses 328a, 328b can provide space for the seals of the valve stem 300 to fold or bend as the valve stem 300 translates within the valve well 320. Thus, the space created by the recesses 328a, 328b can facilitate the formation of a thicker wall thickness T and / or a larger major diameter D1 of the elongate body 302 of the valve stem 300 relative to Figure 4 and Figure 5 the wall thickness T and / or major diameter D1 of the valve stem 300 depicted in Figure 6 , assuming that the corresponding valve stem 300 has the same cavity diameter D L and is configured for use in a valve well having the same inner diameter, since the major diameter D1 no longer needs to be sized to facilitate the folding or bending of the seal.

[0095] It should be understood that the present invention is illustrative in many respects. Changes may be made in details, particularly in the arrangement of shapes, sizes, and steps, without exceeding the scope of the invention. To the extent appropriate, this may include using any of the features of one exemplary embodiment in other embodiments. Of course, the scope of the invention is defined by the language of the appended claims.

Claims

1. A valve stem for a medical device, the valve stem comprising: An elongate body; A first opening in the elongate body; A second opening in the elongate body; A cavity extending from the first opening to the second opening; A first seal extending circumferentially around the elongate body at a position proximal to the first opening; And A second seal extending circumferentially around the elongate body at a position distal to the first opening; Wherein the elongate body, the first seal, and the second seal are formed of a single material.

2. The valve stem according to claim 1, wherein, The elongate body, the first seal, and the second seal are integral.

3. The valve stem according to claim 1 or claim 2, further comprising: A third seal extending circumferentially around the elongate body at a position distal to the second seal, Wherein the third seal is formed of the single material used to form the elongate body, the first seal, and the second seal.

4. The valve stem according to any one of claims 1 to 3, further comprising: A first recess extending circumferentially around the elongate body at a first axial position; And A second recess extending circumferentially around the elongate body at a second axial position spaced apart from the first axial position, Wherein the first seal extends from the first recess to the second recess.

5. The valve stem according to any one of claims 1 to 4, wherein, The single material is a thermoplastic elastomer.

6. The valve stem according to any one of claims 1 to 5, wherein, At an axial position between the first seal and the second seal, the wall thickness of the elongate body between the cavity and the outer surface of the elongate body is in the range of 1.00 mm to 2.00 mm.

7. The valve stem according to any one of claims 1 to 6, wherein, At an axial position between the first seal and the second seal, the wall thickness of the elongate body between the cavity and the outer surface of the elongate body is at least 1.50 mm.

8. The valve stem according to any one of claims 1 to 7, wherein, The single material has a hardness in the range of 50 Shore A to 75 Shore A.

9. The valve stem according to any one of claims 1 to 8, wherein, The first opening is a radial opening, and the second opening is an axial opening in the distal end of the elongate body.

10. A valve stem for a medical device, the valve stem comprising: An elongate body formed of a single material; A first opening in the elongate body; A second opening in the elongate body; And A cavity extending from the first opening to the second opening; Wherein the elongate body includes a first position having a first outer diameter and a second position having a second outer diameter, the first position being configured to be spaced apart from the inner wall of the valve well, the second position being configured to engage the inner wall of the valve well; and Wherein the second position of the elongate body extends circumferentially around the elongate body.

11. The valve stem according to claim 10, wherein, Most of the length of the elongate body has a first outer diameter.

12. The valve stem according to claim 10 or 11, wherein, The wall thickness of the elongate body at the second position is at least 1.50 mm.

13. The valve stem according to any one of claims 10 to 12, wherein, The single material has a hardness in the range of 50 Shore A to 75 Shore A.

14. The valve stem according to any one of claims 10 to 13, wherein: The elongate body has a third position and a fourth position longitudinally spaced apart from the third position, the third position and the fourth position having a third outer diameter, The third outer diameter is less than the first outer diameter, and The second position is located between the third position and the fourth position.

15. The valve stem according to any one of claims 10 to 14, wherein The elongate body includes: one or more positions having a third outer diameter that is less than the first outer diameter; a first region, the first region including a portion having the second outer diameter, the portion having the second outer diameter being located between two positions each having the third outer diameter; and a second region, the second region including a portion having the second outer diameter, the portion having the second outer diameter being located between two positions each having the third outer diameter.

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