Fluid Transfer Device

Abstract

Described herein is a device (100) for transporting fluid from a surgical site, the device (100) comprising an elongated body portion (102) defining a proximal end region (106) of the device connectable to a source of negative pressure, an elongated neck portion (104) defining a distal end region (108) of the device at which the location of the surgical site can be identified, a throughbore extending from the distal end region to the proximal end region, and a control element (116) for selectively controlling negative pressure at the distal end region of the device, the control element comprising a button portion actuatable by a user to selectively move a valve portion of the control element from an open position to a closed position across the throughbore to at least partially restrict fluid flow through the throughbore. Also described are systems including the device (100) and flexible tubing (200), and methods for controlling negative pressure at the distal end region of the device.

Description

[Technical Field]

[0001] The present invention relates to devices for transferring solids and / or fluids from a point, and particularly, but not exclusively, to suction devices for use in the medical industry, for example, during surgical procedures. [Background technology]

[0002] Medical suction devices are often used by physicians or assistants to remove fluids from a surgical site during surgical or investigational procedures, such as abdominal surgery or ear, nose, and throat (ENT) surgery. Conventional ENT suction devices typically include tubing made from stainless steel and having an outer diameter of approximately 1-5 mm. The tubing typically extends from a plastic attachment that connects the tubing to a pump, creating negative pressure at the distal end of the tubing. The attachment is connected to one end of a flexible tube that is coupled to the pump by an interference fit or threaded connection. The attachment may be configured to allow the physician or assistant to hold the device and manipulate the suction tubing during use.

[0003] However, conventional medical suction devices lack or have limited functionality that allows users to efficiently, precisely, and selectively control negative suction pressure at the distal end of the tubing, which can be identified at the surgical site. Uncontrolled suction pressure can cause trauma to delicate organs, resulting in unintended damage and patient morbidity. Furthermore, maneuvering a suction device during a surgical procedure often results in the flexible tubing between the device and the vacuum pump becoming twisted, and a reactive torque is applied to the suction device itself. This reactive torque can unnecessarily restrict the user when maneuvering the suction device and can cause the suction tubing to unintentionally rotate, resulting in patient discomfort. Furthermore, conventional medical suction devices are prone to clogging, particularly at the tip and around connections, for example, between the device and the flexible tubing, when, for example, earwax, coagulated blood, bone fragments, etc., at least partially, and often completely, occlude the tubing, which significantly reduces the performance of the suction device and leads to unwanted downtime during the surgical procedure, increased waste, and increased costs.

[0004] Additionally, conventional medical suction devices are typically noisy because turbulence occurs within the device during use and a constant vacuum is applied to the distal end of the suction tube even when the device is not in use. This can lead to frustration and confusion for the physician, and when the device is used near the ear, the relatively high noise levels can cause acoustic trauma (hearing loss, hyperacusis, and tinnitus) to the patient. Furthermore, conventional medical suction devices are uncomfortable to use over relatively long periods of time and / or during surgical procedures that require a high level of precision from the physician and / or his or her assistants.

[0005] WO 2021 / 140316 describes a medical suction device that is a significant improvement over previously available medical suction devices and addresses many of the problems discussed above, and the applicant has improved the device as described herein. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] International Publication No. 2021 / 140316 Summary of the Invention

[0007] It is an object of certain embodiments of the present invention to provide a medical device for accurately and efficiently transporting solids and / or fluids away from a surgical site.

[0008] It is an object of certain embodiments of the present invention to provide a medical suction device for use by a physician that is comfortable to use over relatively long periods of time.

[0009] It is an object of certain embodiments of the present invention to provide a medical suction device that allows a physician to precisely and efficiently control the amount of suction applied by the device at the surgical site, as well as the noise intensity.

[0010] It is an object of certain embodiments of the present invention to provide a medical suction device that is easy to connect to a vacuum source, such as a pump, and that is not adversely affected by the flexible tubing that couples the device to the vacuum source.

[0011] It is an object of certain embodiments of the present invention to provide a medical suction device that can be used with a selected one of a plurality of differently configured suction tubes based on the surgical procedure and / or surgical site.

[0012] It is an object of certain embodiments of the present invention to provide a medical suction device that is less prone to clogging and is significantly quieter than conventional medical suction devices, especially when not in use.

[0013] It is an object of certain embodiments of the present invention to provide a medical suction device configured to avoid the application of uncontrollable excessive negative pressure to a surgical site, such as the ear, which could otherwise cause trauma to delicate organs resulting in unintended damage and increased patient morbidity.

[0014] It is an object of certain embodiments of the present invention to provide a medical suction device configured to allow for the gradual removal of earwax from the ear canal at a substantially low noise level to reduce / eliminate the risk of acoustic shock.

[0015] It is an object of certain embodiments of the present invention to provide a medical suction device that is configured to allow a user to use the device to implant relatively small prostheses, such as implant ear grommets.

[0016] According to a first aspect of the present invention, there is provided a device for transferring fluid from a surgical site, the device comprising: an elongate body defining a proximal end region of the device connectable to a source of negative pressure; an elongate neck defining a distal end region of the device in which the location of the surgical site can be identified; a through hole extending from the distal end region to the proximal end region; and a control element for selectively controlling the negative pressure at the distal end region of the device, the control element comprising a button portion actuatable by a user to selectively move a valve portion of the control element from an open position towards a closed position across the through hole to at least partially restrict fluid flow along the through hole.

[0017] Optionally, the control element is slidably mounted in a cavity in the body portion such that the valve portion is movable towards a closed position in response to the button portion being pressed by a user.

[0018] Optionally, the valve portion of the control element is slidably mounted in a guide bore that extends substantially perpendicularly into the through bore.

[0019] Optionally, the guide hole is defined by a hollow boss extending upwardly from the base of the cavity.

[0020] Optionally, the control element comprises a vent hole extending from the top surface of the button portion towards the closure base of the valve portion and a vent hole disposed distal to the valve portion, whereby when the control element is in the open position the vent hole is blocked by the guide hole and when the control element is in the closed position the vent hole is positioned to be in fluid communication with the distal hole region of the through hole.

[0021] Optionally, the lower region of the valve portion comprises a curved surface for slidably engaging a corresponding curved seat surface of the through hole, the curved seat surface being continuous with the guide hole and defined at the intersection of the distal and proximal hole regions of the through hole.

[0022] Optionally, the lower region of the valve portion comprises a substantially flat base surface for engaging a corresponding flat base seating surface of the proximal bore region when the valve portion is in the closed position, and the lower region of the valve portion further comprises a substantially flat side surface for engaging a corresponding tapered flat seating surface of the proximal bore region when the valve portion is in the closed position.

[0023] Optionally, the valve portion of the control element is biased towards the open position by a biasing element, and the button portion of the control element comprises a first abutment surface for engaging a first stop surface on the body portion of the device when the valve portion is in the open position to limit travel of the control element.

[0024] Optionally, the first abutment surface is provided by a first flange region extending proximally from a lower region of the button portion, and the first stop surface is provided by an edge region extending distally from an upper edge region of the cavity.

[0025] Optionally, the button portion comprises a second abutment surface for engaging a second stop surface on the body portion to limit travel of the control element when the valve portion is in the closed position.

[0026] Optionally, the second abutment surface is provided by a second flange region extending proximally from the upper region of the button portion, and the second stop surface is provided by the margin region.

[0027] Optionally, the button portion comprises a third abutment surface for engaging the second stop surface to retain the valve portion in the locked position.

[0028] Optionally, the third abutment surface is provided by the second flange region and the second stop surface is provided by the margin region.

[0029] Optionally, the second flange region and / or the edge region are substantially resilient, thereby allowing the second flange region to be biased past the edge region and engage under the edge region as the control element moves from the closed position to the locked position.

[0030] Optionally, the button portion is tiltable toward the proximal end region of the device to position the second flange region beneath the edge region, and / or tiltable toward the distal end region of the device to release the second flange region from beneath the edge region.

[0031] Optionally, when the valve portion is in the closed position, a minimal amount of fluid is allowed to flow along the through hole and past the valve portion, and when the valve portion is in the locked position, substantially no fluid is allowed to flow along the through hole and past the valve portion.

[0032] Optionally, when the valve portion is in the locked position, the curved surface of the valve portion is biased against a curved seat surface of the through bore.

[0033] Optionally, the inner surface of the through-hole tapers outward in a distal to proximal direction.

[0034] According to a second aspect of the present invention, there is provided a system for transporting fluid from a surgical site, the device comprising: a device according to the first aspect of the invention; at least one suction tube mountable at a distal end region of the device; Optionally, it further comprises a flexible tube connectable to the proximal end region and rotatable relative to the device.

[0035] According to a third aspect of the present invention there is provided the use of a device according to the first aspect of the present invention or a system according to the second aspect of the present invention to transport fluids or solids from a target site.

[0036] According to a fourth aspect of the present invention, there is provided a method of selectively controlling negative pressure at a distal end region of a suction device, the method comprising: This includes actuating a button portion of a control element of the suction device to move a valve portion of the control element across the through-hole of the device from an open position to a closed position to substantially restrict fluid flow from the distal end region through the valve portion and along the through-hole, thereby substantially reducing but not ceasing the negative pressure at the distal end region of the device.

[0037] Optionally, activating comprises pressing a button portion.

[0038] Optionally, the method comprises lifting the object at a distal end region of the device when the valve portion is in the closed position.

[0039] Optionally, the object comprises a medical implant.

[0040] Optionally, the method includes moving the control element from a closed position to a locked position, wherein at least one sealing surface of the valve portion is biased against a seating surface of each of the through holes, thereby preventing excess flow through the valve portion.

[0041] Optionally, the method includes at least partially removing the user's finger or thumb from the button portion to at least partially uncover an opening in the button portion to allow negative pressure in the distal hole region of the through-hole and upstream of the valve portion to be vented to atmosphere via a vent in the control element that is in fluid communication with the distal hole region when the valve portion is in the locked position.

[0042] Specific embodiments of the present invention will now be described with reference to the accompanying drawings. [Brief explanation of the drawings]

[0043] [Figure 1] 1 illustrates an isometric view of a suction device, in accordance with certain embodiments of the present invention. [Figure 2] 2 shows a cross section of the device of FIG. 1. [Figure 3a] 1 shows a cross-sectional view of the device when the control element is in the open position. [Figure 3b] 1 shows a cross-sectional view of the device when the control element is in the open position. [Figure 3c] 1 shows a cross-sectional view of the device when the control element is in the open position. [Figure 4a] 1 shows a cross-sectional view of the device when the control element is in the closed position. [Figure 4b] 1 shows a cross-sectional view of the device when the control element is in the closed position. [Figure 4c] 1 shows a cross-sectional view of the device when the control element is in the closed position. [Figure 5] 1 shows a cross-sectional view of a suction tube attached to the distal end of the device. [Figure 6a] 1 shows a flexible tube connected to the proximal end of the device. [Figure 6b] A cross-sectional view of the proximal end of the device and the distal end of the tube connected to the proximal end is shown. [Figure 6c] 1 shows the attachable flexible tube at the proximal end of the device. [Figure 6d] 1 shows the attachable flexible tube at the proximal end of the device. DETAILED DESCRIPTION OF THE INVENTION

[0044] 1, a suction device 100 according to certain embodiments of the present invention includes an elongated body portion 102 and an elongated neck portion 104 extending therefrom. The body portion 102 defines a proximal end region 106 of the device for attaching a flexible tube 200 to the device, which tube 200 is coupled in use to a negative pressure source, such as a vacuum pump, and the neck portion 104 defines a distal end region 108 of the device for attaching a suction tube 112 to the device. As described further below, the device 100 further includes a control element 116 that, in use, allows a user to selectively stop, start, and control the level of suction provided at the distal end of the suction tube 112.

[0045] The central axis of the distal end region 108 of the neck 104 of the device is angled relative to the central axis of the proximal region 109 of the neck 104. The angle is approximately 25 degrees, but may suitably be between 0 degrees (i.e., coaxial with the proximal region 109) and approximately 45 degrees, or any angle appropriate for a particular surgical application. The central axis of the proximal region 109 of the neck 104 is substantially coaxial with the axis of the body 102. The central axes of the distal and proximal end regions of the neck may be substantially straight, or they may be curved to provide a curved, continuous axis extending substantially through the curved neck. Providing the neck 104 with an angled distal end region 108 desirably allows for the device to accommodate a selected one of multiple suction tubes / nozzles. As shown, the suction tube 112 may be substantially straight. Although curved suction tubes with internal bends can be used with the device, straight suction tubes 112 (i.e., tubes without bends) are relatively uncomplicated and inexpensive to manufacture and are easier and less expensive to sterilize or reuse than angled / bent suction tubes. Additionally, alternatively configured attachments can be coupled to the distal end of the device, including straight, curved, or right-angled needles, or elongated probe devices that do not, for example, aspirate, blow, or dispense. Such attachments can be selectively interchangeable by the user for different applications during a surgical procedure. While the outer surface of the distal end region of the neck as shown is substantially circular in cross-section to accommodate a correspondingly shaped attachment such as a suction tube, the distal end region can alternatively be substantially square, oval, hexagonal, or the like. The tip region of the suction tube 112 can be substantially flexible to absorb impact with relatively hard tissue, such as the inside of the ear, minimizing any discomfort to the patient. The tip opening may be beveled to avoid any sharp edges and to guide and encourage fluids and solids into the aspiration tube in use.

[0046] As shown in FIG. 5 , a suction tube / nozzle 112 mountable on a device according to certain embodiments of the present invention may be a one-piece stainless steel or plastic part having an attachment portion 113 configured to mount to the distal end region 108 of the device's neck 104 via a simple interference fit, for example. The inner surface 115 through the suction tube 112 tapers outward from its tip along its length, although alternatively, the inner surface may have parallel surfaces. The distal end region 108 of the device's neck 104 and the attachment portion 113 of the suction tube(s) 112 are configured to provide a sealed connection therebetween and a substantially continuous, smooth inner wall surface to at least minimize any bumps, gaps, etc., which may create turbulent flow effects, such as noise, and prevent blockages during use. Suitably, the suction tube is formed from a plastic / polymer material such as polyoxymethylene (POM) due to its relatively low coefficient of friction, allowing the suction tube to be efficiently mounted and detached from the distal end of the device, and at least minimizing, if not preventing, blockage during use.

[0047] An optional cap or cover (not shown) with a closed distal end can be fitted over the suction tube to protect the suction tube and prevent dirt and the like from entering the tube and device when not in use. Alternatively, the distal end of the cover can be open, for example, to aid in manufacturing. Suitably, the cover can provide a visual and / or tactile indication that the suction tube has been previously used on a different patient and therefore does not need to be cleaned for use. For example, the cover can be coloured and / or attached to a portion of the suction tube by a frangible region that is broken when the cover is removed from the tube. When the cover is removed by a first user, it is apparent to a second user that the suction tube has been previously used.

[0048] The body portion 102 and neck portion 104 are substantially circular in cross section and integrally formed by suitable means, such as injection molding. Suitably, the body portion 102 and neck portion 104 are formed from a plastic material, such as polycarbonate. The body portion 102 has a maximum outer diameter that is greater than the maximum outer diameter of the neck portion 104. The outer surface of the body portion 102 tapers inward toward the proximal end region 106, and the outer surface of the neck portion 104 tapers inward toward the distal end region 108. The body portion 102 is sized and shaped to ergonomically fit a user's hand while allowing the thumb or fingers to comfortably engage and selectively actuate the control element 116. The body portion 102 may be formed from a material, such as plastic or rubber, having a relatively high coefficient of friction compared to the neck portion 104, or may include one or more such portions / surfaces to provide a user with a grip when holding the device. The control element 116 is suitably a unitary component formed by injection molding or the like. Suitably, the control element 116 is formed from a plastic / polymer material such as polyoxymethylene (POM) and may include a top surface texture and / or material to provide grip when a user's thumb or finger engages it.

[0049] 2, device 100 includes a throughbore 118 extending from distal end region 108 to proximal end region 106, which allows fluid to flow from suction tube 112 through the device. Throughbore 118 is substantially centrally, i.e., axially, disposed through neck portion 104 and body portion 102 and gradually tapers outward along its length toward proximal end region 106 of the device. Optionally, however, bore 118 initially tapers inward from the open end of beveled distal end region 108 to the beginning of neck portion 104, where it gradually tapers outward toward proximal end region 106 of the device. Optionally, the bores in distal end region 108 and neck portion 104 taper in opposite directions to facilitate the removal of corresponding tapered injection molded pins in opposite directions from a molded product during manufacture of the device. Additionally, the slight narrowing of the bore in the distal end region 108 acts to accelerate and draw fluid from the suction tube 112 into the neck 104, preventing any accumulation or blockage within the relatively narrow suction tube and around the angled bend 103 in the neck.

[0050] The through-hole 118 has a minimum diameter of approximately 2 mm at the junction 103 between the distal end region 108 and the neck 104 and a maximum diameter of approximately 15 mm at the proximal end 106 of the device. The distal end opening has a diameter of approximately 3 mm, but may be up to 8 mm in certain applications. The gradual outward taper of the through-hole from the neck 104 through the body 102 desirably prevents the accumulation of solid matter, such as blood or tissue, which may unnecessarily result in reduced suction or complete blockage of the through-hole. The inner surface of at least the through-hole in the neck 104 of the device is also substantially continuous along its length, free of abrupt angles, steps, gaps, or gaps that would otherwise be caused by abrupt changes in wall orientation, and free of connections / joints that could result in blockages and / or fluid turbulence, further compromising suction and introducing noise. Any undesirable step along the relatively narrow distal region of this bore can cause air turbulence which results in noise, and / or waste material such as blood can be transported away from the surgical site and dry, resulting in accumulation and blockage of the bore during use.

[0051] As shown in Figures 3a-3c, the body portion 102 includes a cavity 120 extending from its upper outer surface toward the through bore 118. The cavity 120 is defined by a base surface 122 and a continuous sidewall surface 124. The cavity opening defines a substantially circular rectangular shape. A hole in the base of the cavity 120 communicates with the through bore 118 and is surrounded by a hollow boss 126 that extends upward from the base surface 122 toward the cavity opening. The cylindrical hollow boss 126 terminates below the cavity opening and defines a circular guide hole 128 that extends substantially vertically within the through bore 118. The cavity 120 is sized and shaped to at least partially receive and accommodate the control element 116, allowing the control element 116 to be mounted within the cavity and move inward and outward relative to the body portion 102 in a direction substantially perpendicular to the axis of the through hole 118.

[0052] Control element 116 includes a button portion 130 and an elongated valve portion 132 extending downwardly from the bottom surface of the button portion. In plan view, button portion 130 is substantially elongated with curved front and rear ends, defining a circular rectangle, but may be substantially oval, circular, rectangular, etc. Button portion 130 includes a continuous sidewall / skirt region 134 extending downwardly from an upper region 136 to define a bell- or cap-shaped button portion having a substantially open lower edge region 138. As described further below, upper region 136 defines an upper surface 140 for placement of a user's thumb or finger to selectively bias (depress) button portion 130 of control element 116 into cavity 120 and move valve portion 132 toward a closed position. As described further below, the upper region 136 of the button portion 130 includes an upwardly facing leading edge or wall 142 and an upwardly facing trailing edge or wall 144 to accommodate a user's finger or thumb to enable efficient and comfortable operation of the control element 116.

[0053] Valve portion 132 extends downwardly from a distal (forward) region of button portion 122 beyond a lower edge region of skirt 134. Button portion 130 and valve portion 132 define a mushroom shape and are integrally formed, although they may be separate components connected together. An integrally formed control element 116 desirably reduces the number of moving / coupled parts, reduces assembly time and cost, and provides a less complex control mechanism in which the control element acts as both a button and a valve element.

[0054] The valve portion 132 is substantially elongated, and its upper region 146 has a substantially circular cross-section with an outer diameter that matches the inner diameter of the circular guide bore 128, such that at least the upper region 146 of the valve portion 132 slidably engages and is guided by the guide bore 128 when the control element 116 is selectively moved by a user between the open and closed positions of the valve. The interface between the valve portion 132 and the guide bore 128 does not require a sealing interface. The upper region 146 of the valve portion 132 and the guide bore 128 is circular in cross-section, but may be substantially oval, hexagonal, square, etc. in cross-section. The lower region 148 of the valve portion 132 has a curved front / distal surface 150 that matches the front curvature of the upper region 146 of the valve portion 132, defining a continuous convex surface of uniform curvature extending along the front length of the valve portion. A front curved surface 150 of the lower region of the valve portion slidably engages with a corresponding curved surface 152 of the through hole 118, the curved surface 152 continuing at the guide hole 128 and defined at the intersection of the distal hole region 117 and the proximal hole region 119 of the through hole 118.

[0055] The distal bore region 117 extending through the neck portion 104 of the device 100 is substantially circular in cross section, although the distal bore region 117 may alternatively be elliptical, oval, or the like. The proximal bore region 119 has four substantially flat inner surfaces extending along its length, although the proximal bore region 119 may alternatively be elliptical, oval, or the like, suitably along at least a portion of its length downstream of the valve portion 132 and valve seat surface of the proximal bore region 119. The proximal bore region 119 is defined, at least in part, by a flat base surface 164, opposing flat side surfaces 165, and a flat top surface 169. The base surface 164 of the proximal bore region 119 is lower than the distal bore region 117, such that the curved surface 152 of the through-hole 118 extends downward beyond the distal bore region 117 and touches the base surface 164 of the proximal bore region 119.

[0056] 3a and 3b, a rear surface 154 of the lower region 148 of the valve portion 132 is substantially flat so as to define an undercut / shoulder surface 156. The flat rear surface 154 and the shoulder surface 156 extend transversely to the longitudinal axis of the device and define a gap 157 between the valve portion 132 and the guide hole 128. The gap 157 desirably reduces potential sliding contact between the valve portion 132 and the guide hole 128, thereby reducing static friction when the control element 116 is in the open position.

[0057] As shown in FIG. 3c, opposing side surfaces 158, 160 of the lower region 148 of the valve portion 132 are substantially flat and taper outward from a flat base surface 162 of the valve portion 132 upward toward the button portion 130. When the control element 116 is in the closed position, as shown in FIGS. 4a-4c, the flat base surface 162 of the valve portion 132 engages a flat base surface 164 of the through-bore 118, and the flat, tapered side surfaces 158, 160 of the valve portion 132 each engage a corresponding flat, tapered side surface 166, 168 of the through-bore 118. The tapered surfaces provide an efficient seal when biased together, while static friction forces prevent the control element 116 from returning to the open position when thumb / finger pressure is released from the button portion 130 of the control element 116. The tapered surfaces are suitably at approximately 6 degrees relative to the vertical axis. The curved front surface 152, the flat base surface 164, and the tapered sides 166, 168 of the proximal bore region 119 act as valve seat surfaces that are engaged by corresponding surfaces of the lower region 148 of the valve portion 132 when the control element 116 is in the closed position.

[0058] As explained further below, the opposing tapered sides 166, 168 of the through bore, which serve as valve seating surfaces, may optionally include at least one groove, such as a plurality of spaced parallel grooves extending above each tapered surface, which reduces the contact area between the valve portion 132 and the tapered seating surface and also reduces the effect of any static friction forces when the valve portions of the control element 116 are in the closed or locked position, while also providing an efficient seal between the corresponding tapered surfaces when they are biased together.

[0059] The control element 116 also includes a vent 170 that extends downward from the upper surface 140 of the button portion 130, along the valve portion 132, toward the closed base of the valve portion. The vent 170 is oriented substantially perpendicular to the through-hole 118 of the device. A vent hole 172 is disposed in the curved front surface 150 of the lower region 148 of the valve portion 132, above and proximally above the base of the vent 170 in communication therewith. As shown in FIGS. 3a and 3b, when the control element 116 is in the open position, the vent hole 172 is blocked by the guide hole 128. As shown in FIGS. 4a and 4b, when the control element 116 is in the closed position, the vent hole 172 is positioned in fluid communication with the distal hole region 117.

[0060] The control element 116 is mounted to a compression spring 180 (as shown in FIG. 3a) that biases the valve portion 132 toward the open position. The spring 180 is mounted on the guide boss 126 and engages the underside of the button portion 130 of the control element 116. The spring, or other suitable biasing element, may engage different areas of the control element 116 to bias the valve member toward the open position when no force is applied to the button portion 130 by the user. For example, the biasing element(s) may include a flexible and resilient plastic lever, compressible rubber, or foam element, etc. The spring may be a linear spring or a progressive spring.

[0061] The control element 116 may alternatively be configured to be biased toward the closed position by a biasing element, such as a compression or tension spring, and the user must move the control element, and thus the valve portion, toward the open position to selectively control suction at the distal end of the device.

[0062] The control element 116 may alternatively be configured to slide longitudinally or rotate relative to the body portion 102 of the device to selectively control airflow through the device and, in turn, the suction pressure at the distal end. For example, the button portion may be a slider movable by a user's finger or thumb along a track, which in turn moves the valve portion relative to the through-hole to adjust fluid flow through the device. Alternatively, the button portion may be a knob rotatable by a user to move the valve portion relative to the through-hole to adjust fluid flow through the device.

[0063] 3a and 3b, the control element 116 further includes at least one lower protrusion 182, such as a flange or shoulder, extending outward from a rearward / proximal lower end region of the skirt 134 of the button portion 132, configured to engage a corresponding marginal region 184 extending inward from an upper rearward edge region of the cavity 120 of the body portion 102. The marginal region 184 acts as a stop, limiting the travel of the control element 116 biased by the spring 180, thereby coupling the control element 116 to the body portion 102 when the control element 116 is in the open position corresponding to the fully opened through-hole 118. The lower protrusion 182 may be a plurality of spaced apart protrusions extending around at least the rearward / proximal end region of the skirt 134, or the lower protrusion 182 may include a continuous flange or shoulder extending around at least the rearward / proximal end region of the skirt 134. Suitably, the lower flange 182 may extend around the periphery of the skirt 134 and the corresponding marginal region 184 may extend around the periphery of the opening 120 .

[0064] The control element 116 further includes at least one upper protrusion 186 extending outward from a rearward / proximal upper end region of the button portion 130, the upper protrusion 186 configured to engage a margin region 184 extending inward / forward from an upper rear edge region of the opening 120 in the body portion 102. The upper protrusion 186 is suitably a flange region extending outward from the button portion 130 and continuing with the upper surface 140 of the control element 116. When the control element 116 is pressed down into the cavity 120, thereby engaging the upper flange 186 with the margin region 184, the upper flange acts as a stop to limit the movement of the control element within the cavity of the device. In this position, the control element 116 is in a closed position, with its valve portion 132 positioned entirely across the through-bore 118. Alternatively, the device may be configured such that when no force is applied to the control element, the valve portion is biased towards the closed position and the valve portion may be locked in the open position. Further alternatively, the valve member may be locked in one or both of the fully open and fully closed positions and / or may be locked in one of a number of different positions between the fully open and fully closed positions by 25%, 50%, etc.

[0065] Additionally, the recess of control element 116 within cavity 120 biases upper flange 186 downward and through edge region 184, such that edge region restrains the control element against the counterforce of spring 180, preventing the control element from returning to the open position when the user's finger is removed. As explained further below, control element 116 is now in a locked position, and fluid cannot flow through the device from distal bore region 117 to proximal bore region 119. For example, the slight flexibility / resilience of elongated valve portion 132 allows button portion 130 of control element 116 to tilt or rotate slightly back and forth within cavity 120, thereby allowing upper flange 186 to move away from edge region 184 and lock / unlock control element 116 as desired. Alternatively or additionally, the upper flange 186 and / or marginal region 184 may be substantially resilient and slightly flexible to allow the upper flange 186 to be pushed through and past the marginal region 184, thereby moving the control element 116 from the closed position to the locked position, or vice versa. Further, alternatively or additionally, the upper flange 186 and / or marginal region 184 may be substantially curved, tapered, beveled, etc., to allow the upper flange 186 to efficiently pass through the marginal region when biased by a user toward or from the locked position. A lower flange 189 extends from a lower front edge of the skirt region 134 of the button portion 130 to engage the front inner surface of the cavity 120 and act as a pivot when the button portion 130 is tilted / rotated forward to lock and / or unlock the control element 116. Alternatively, the locking element may be movable by a user and engage a portion of the control element, such as a button portion, thereby locking the portion in a locked position. For example, the locking element may be slidably movable relative to the body portion and at least partially cover or engage the button portion to prevent the control element from being biased by the spring toward the open position.

[0066] As shown in Figures 3a-3c, when valve portion 132 is in the open position, i.e., when no force is applied to control element 116 and control element 116 is biased to the open position by spring 180, a total suction pressure of approximately -60 to -80 dPa is achieved at the distal tip of the device.

[0067] When the control element 116 is pressed into the closed position by the user, a relatively light / weak suction pressure is realized at the tip of the device, with the user's finger / thumb covering the vent hole above the button portion 132. When the valve portion 130 is in the closed position, the flow rate drops significantly, and the negative pressure upstream of the valve drops to approximately -40 dPa. As the pressure difference across the valve portion equalizes, the negative pressure at the tip of the device gradually increases to approximately -60 to -80 dPa. Desirably, but optionally, a perfect / total seal does not occur / is not achieved when the control element 116, and thus its valve portion 132, is in the closed position as a result of design tolerances and surface roughness. That is, fluid (air) flows through and past the valve portion via minute passages. Alternatively or additionally, as further described below, at least two or more defined passages (e.g., grooves, etc.) may be disposed along the flat base surface of the valve portion 132 that are open at its front and rear surfaces, such that when the valve portion is in the closed position, fluid is allowed to leak through the passages, but when the control element 116 is in the locked position, the front openings of the passages are closed when the valve portion is urged forward against a corresponding curved front seat surface. The increased negative pressure at the proximal bore region 119, and thus the pressure differential across the valve portion 132, also acts on the rear surface of the valve portion 132, urging the front curved surface 150 of the valve portion 132 away from the front curved surface 152 of the through-hole 118, allowing fluid (air) to leak from the distal bore region to the proximal bore region, albeit at a relatively low / minimal rate, through and across the valve portion, thus creating a relatively low / weak suction pressure at the tip of the device, sucking fluid and / or solids (such as blood, bone chips, or earwax) into the suction tube 112, and possibly into the distal bore region 117 of the device in a relatively low volume. Because the inner surface of the suction tube 112 tapers outward, earwax, for example, is sucked into the suction tube without causing the suction tube to become occluded, and the "weak" suction pressure remains substantially constant. If the inner surfaces of the suction tube were substantially parallel, as is the case with many conventional suction tubes, the frictional effect between the inner surfaces would cause earwax to be drawn further into the suction tube, causing the suction tube to remain blocked.Additionally, the outward tapering of the distal bore region 117 towards the valve portion 132 allows earwax or other solids to collect in the distal bore region 117 without blockage. This slow leak feature allows for gradual removal of earwax at a particularly low noise level, for example, when the control element / button 116 is depressed in the closed position by the user's finger or thumb, reducing / eliminating the risk of either acoustic shock or other discomfort to the patient.

[0068] Additionally, a user's finger or thumb can be placed over the vent 170 when the control element 116 is in the closed position, gradually increasing a relatively low negative pressure in the distal bore region 117 and the suction tube 112 for "soft suction" applications. For example, the device can be used during a surgical procedure to gradually extract earwax or to lift, manipulate, and locate a prosthesis, such as a fine, lightweight ear grommet. When the user's thumb is removed from the vent 170, the distal bore region 117 of the device is placed in fluid communication with the atmosphere via a vent hole 172 located in the through-hole 118 when the control element 116 is in the closed position. This allows air to enter the distal bore region 117 via the vent 170 and the vent hole 172, which in turn releases the negative pressure and low / weak suction pressure therein at the tip of the suction tube, thereby releasing the prosthesis from the device and implanting it in the desired location.

[0069] As explained above, the control element 116 can be placed in a locked-down position in which the rearward / proximal region of the button portion 130, when further pushed downward from the closed position, urges the upper flange 186 over and beneath the marginal region 184 of the cavity 120. The downward slope of the upper surface of the marginal region helps guide the upper flange 186 over and beneath the marginal region 184. Although the control element 116 is formed from a relatively rigid material such as polyoxymethylene (POM), the control element 116 has a degree of resilience that allows the rearward region of the button portion 130 to flex slightly, and also to flex and pivot slightly around the upper rear edge of the guide hole 128 when pushed downward and beneath the marginal region 184 of the peripheral cavity 120. Suitably, POM has a particularly low coefficient of friction, which ensures that the control element 116 slides efficiently within the guide bore 128 between the open and closed positions. Despite being relatively low, given the material's restoring force, the rotational reaction force is transferred through the control element 116 and urges the lower end of the valve member 132 forward, which in turn urges the lower curved surface of the valve member against the curved sealing surface 152 of the proximal bore region 119. Suitably, the flat rear surface 154 and flat base surface 162 of the valve portion 132 define a straight lower rear edge of the valve portion, which ensures that when the valve portion tilts slightly rearward at its lower edge, a generally efficient seal along its lower edge is maintained by the flat base of the bore 119. This would not be possible if the rear surface of the valve member, and thus the lower rear edge, were curved. Additionally, the downward force on the control element further urges the base surface and tapered surface of the valve portion 132 against the base surface and corresponding tapered sealing surface of the proximal bore region 119. Thus, a substantially complete seal is achieved closing off the distal bore region 117 from the proximal bore region 119 when the control element 116 is in the locked-down position. Because there is a sliding contact between the valve portion 132 and the guide bore 128, air can be drawn into the proximal bore region 119 through the guide bore.However, there is zero, or at least negligible, suction pressure at the distal tip of the device, allowing the "lockdown" position of control element 116 to be used as an "emergency stop" function if tissue is actively held at the tip and / or the patient experiences discomfort.

[0070] To unlock the control element 116 from the locked-down position, the button portion 130 is urged forward by the user's thumb or finger, slightly rotating / tilting the control element 116 within the cavity. A lower flange 189 extending from the lower front edge of the skirt region 134 of the button portion 130 may act as a stop to limit the forward movement of the button portion 130 within the cavity 120, but also serves as a pivot when the button portion is rotated forward. The forward movement and slight forward rotation urges the upper flange 186 past the marginal region 184 of the cavity 120, further allowing the spring 180 to bias the control element back to the open position. The upwardly facing front and rear upper edges of the button portion 130 desirably accommodate the user's thumb thereon and provide a surface to press against as the button portion 130 is selectively tilted / rotated during the locking or unlocking operation.

[0071] 6a and 6b, the proximal end region 106 of the device 100 is configured to connect to an end fitting 250 of a flexible tube 200 that is coupled to a negative pressure source, such as a vacuum pump. The proximal end region 106 of the device includes an annular recess 252 adjacent to an enlarged shoulder 254 having tapered distal and proximal end faces 256, 258. The proximal end region 106 of the device tapers outward from the proximal end of the device to the enlarged shoulder 254 to provide a tapered external engagement surface 260.

[0072] The end fitting 250 of the flexible tubing 200 includes an internal engagement surface 262 that tapers inward from the open end region of the end fitting 250. The taper angle of the internal engagement surface 262 of the end fitting matches the taper angle of the external engagement surface 260 of the proximal end region of the device, thereby providing a sealed connection between the engagement surfaces when the end fitting 250 is connected to the device. The end fitting 250 includes a plurality of circumferentially spaced slots 264 that extend longitudinally from the opening of the end fitting. The slots define spaced apart resilient ends 266 that flex radially outward when the end fitting is axially urged across the proximal end region of the device. Each end 266 of the end fitting includes a protrusion 268, such as a partial annular rib, that fits into an annular recess 252 in the proximal end region 106 of the device, sealingly and securely connecting the end fitting to the device. Alternatively, the end fitting 250 may be sufficient to cause the flexible and resilient material to expand outward when forced across the proximal end region 106 of the device, thereby eliminating the need for spaced apart slots 264 defining the resilient ends 266.

[0073] The tapered proximal end surface 258 of shoulder 254 acts to guide end 266 of the end fitting against shoulder 254 and urge end 266 radially outward until end 266 clears shoulder 254 and engages annular recess 252. The tapered distal end surface 256 of shoulder 254 cooperates with a corresponding tapered surface of each rib 268, thereby urging end fitting 250 axially onto the device when end 266 is desired to resiliently enter annular recess 252. These contact surfaces provide a substantially effective seal between the end fitting and the device.

[0074] Additionally, tapered outer surface 260 engages a corresponding surface on the inside of the end fitting, providing an additional sealing contact surface. Desirably, the circular cross-section of the device's proximal end region 106 and the correspondingly sized and shaped end fitting 250, specifically the snap-fit ​​relationship between annular recess 252 and end fitting rib(s) 268, allows the end fitting, and therefore the flexible tubing 200, to rotate relative to the device during use, and vice versa. This eliminates the risk of the flexible tubing being twisted and / or subjecting the device to reaction torque during a surgical procedure. This arrangement also allows for fast connection and disconnection of devices to and from the flexible tubing, and provides a continuous and smooth transition from the device to the tubing, eliminating any turbulent effects, such as noise, and preventing blockage at the connection interface(s).

[0075] As shown in Figures 6b-6d, flexible tubing 200 includes end fittings 250, 350 at each end of a flexible tubing member 270. The tubing member 270 includes a tubular wall 272 that provides a continuous interior tubular surface for transporting fluid, and a plurality of longitudinally spaced annular portions 274 that are arranged substantially parallel to one another. The wall 272 and annular portions 274 are integrally formed, such as by injection molding. Alternatively, the annular portions 274 may be part of a separate structure within which the wall 272 is located. For example, the tubular wall 272 may be a flexible tube located inside a structure that includes the annular portions 274 protecting the wall 272.

[0076] Adjacent portions of the annular portion 274 are joined together by longitudinally oriented hinge elements 276. The hinge elements 276 are arranged along radially opposite sides of the flexible tube, alternating such that a first hinge element is located on a first side of the tube, a second hinge element is located on a second side of the tube opposite the first side, and a third hinge element is located on the first side of the tube. This arrangement allows the tube to bend in all four directions (i.e., up, down, left, and right). The annular portion 274 is also relatively rigid compared to the relatively flexible tubular wall 272, protecting the tubular wall. The rigid annular portion 274 also prevents the tubular wall 272 from collapsing and closing when the tubular wall 272 is subjected to negative pressure from a vacuum source. Suitably, the tubular member 270 is made from a plastic material such as a thermoplastic elastomer and the end fittings 250, 350 are made from polycarbonate.

[0077] Thus, certain embodiments of the present invention provide a suction device for accurately and efficiently removing fluids from a surgical site, such as during an ENT procedure, or for removing fluids from the upper airway while a patient is anesthetized. The suction device is comfortable for relatively long-term use and allows the user to accurately and efficiently control the amount of suction applied by the device to a surgical site, such as the ear, nose, throat, or intracranial cavity. The suction device is easily and quickly connected to a vacuum source, such as a pump, and the flexible tubing connecting the device to the vacuum source does not become kinked during use. The suction device can be used with a selected one of several differently configured suction tubes, making it inexpensive and uncomplicated to manufacture, sterilize, or reuse. The suction device is less prone to blockage and is quieter than conventional suction devices, especially when suction is not needed. A suction device according to certain embodiments of the present invention is configured to allow the user to select between full suction mode, soft suction mode, and a variety of different suction pressures between those modes, as well as to substantially shut off suction at the tip of the device, if desired. The suction device is also configured to allow a user to gradually extract earwax from the ear without risking ear damage or other discomfort to the patient. The suction device is also configured to allow a user to efficiently lift, manipulate, locate, and release a prosthesis, such as an ear grommet, within the patient's ear at a desired implantation location.

[0078] While devices according to certain embodiments of the present invention are particularly suitable as suction devices for the medical industry, the devices may also be suitable for non-medical applications and / or may be used as spraying devices for spraying fluids or solids, such as compressed air, at an object, or as dispensing devices for dispensing fluids or solids at a target location. The tapered interior bore suitably compresses fluids extruded through the device from the proximal bore region toward the distal end of the device, further increasing the pressure and flow rate of the fluid, such as air, exiting the distal end of the device. The control element is suitably configured to allow a user to precisely control the pressure and / or velocity of the fluid exiting the nozzle. The tapered nozzle is also suitably configured to precisely localize the compressed air or the like at an object.

Claims

1. 1. A device for transporting fluids from a surgical site, comprising: an elongate body defining a proximal end region of the device connectable to a source of negative pressure; an elongated neck defining a distal end region of the device that allows for locating a surgical site; a through hole extending from the distal end region to the proximal end region; a control element for selectively controlling negative pressure at the distal end region of the device, the control element comprising a button portion actuatable by a user to selectively move a valve portion of the control element from an open position toward a closed position across the through-bore to at least partially restrict fluid flow through the through-bore; and A device comprising:

2. 2. The device of claim 1, wherein the control element is slidably mounted in a cavity in the body portion such that the valve portion is movable toward the closed position in response to the button portion being pressed by the user.

3. The device of claim 2 , wherein the valve portion of the control element is slidably mounted in a guide hole that extends substantially perpendicularly into the through hole.

4. The device of claim 3 , wherein the guide hole is defined by a hollow boss extending upwardly from a base of the cavity.

5. 5. The device of claim 3, wherein the control element comprises a vent hole extending from the top surface of the button portion toward the closure base of the valve portion and a vent hole disposed distal to the valve portion, such that when the control element is in the open position, the vent hole is blocked by the guide hole and when the control element is in the closed position, the vent hole is positioned to be in fluid communication with a distal hole region of the through hole.

6. 6. A device as described in any one of claims 3 to 5, wherein the lower region of the valve portion comprises a curved surface for slidably engaging a corresponding curved seat surface of the through hole, the curved seat surface being continuous with the guide hole and defined at the intersection of the distal hole region and the proximal hole region of the through hole.

7. 7. The device of claim 6, wherein the lower region of the valve portion comprises a substantially flat base surface for engaging a corresponding flat base seating surface of the proximal bore region when the valve portion is in the closed position, and the lower region of the valve portion further comprises a substantially flat side surface for engaging a corresponding tapered flat seating surface of the proximal bore region when the valve portion is in the closed position.

8. 8. A device as described in any preceding claim, wherein the valve portion of the control element is biased towards the open position by a biasing element, and the button portion of the control element comprises a first abutment surface for engaging a first stop surface on the body portion of the device to limit travel of the control element when the valve portion is in the open position.

9. 9. The device of claim 8, wherein the first abutment surface is provided by a first flange region extending proximally from a lower region of the button portion, and the first stop surface is provided by a margin region extending distally from an upper edge region of the cavity.

10. 10. The device of claim 8 or 9, wherein the button portion comprises a second abutment surface for engaging a second stop surface on the body portion to limit travel of the control element when the valve portion is in the closed position.

11. 11. The device of claim 9 or 10, wherein the second abutment surface is provided by a second flange region extending proximally from an upper region of the button portion, and the second stop surface is provided by a margin region.

12. 12. A device as claimed in claim 10 or 11, wherein the button portion comprises a third abutment surface for engaging the second stop surface to retain the valve portion in a locked position.

13. The device of claim 12 , wherein the third abutment surface is provided by a second flange region and the second stop surface is provided by a marginal edge region.

14. 14. The device of claim 13, wherein the second flange region and / or the edge region are substantially resilient, thereby allowing the second flange region to be biased past the edge region and engage under the edge region as the control element moves from the closed position to the locked position.

15. 15. The device of claim 13 or 14, wherein the button portion is tiltable toward the proximal end region of the device to position the second flange region beneath the edge region, and / or tiltable toward the distal end region of the device to release the second flange region from beneath the edge region.

16. 16. A device as described in any one of claims 12 to 15, wherein when the valve portion is in the closed position, a minimal amount of fluid is allowed to flow along the through hole and past the valve portion, and when the valve portion is in the locked position, substantially no fluid is allowed to flow along the through hole and past the valve portion.

17. 17. The device of claim 6 or 16, wherein when the valve portion is in a locked position, the curved surface of the valve portion is biased against the curved seat surface of the through hole.

18. The inner surface of the through-hole tapers outward from the distal to the proximal direction.

18. A device according to any one of 17.

19. 1. A system for transporting fluids from a surgical site, comprising: A device according to any of the preceding claims; at least one suction tube mountable at the distal end region of the device; Optionally, the system further comprises a flexible tube connectable to said proximal end region and rotatable relative to said device.

20. Use of a device according to any of claims 1 to 18 or a system according to claim 19 for transporting fluids or solids from a target site.

21. 1. A method of selectively controlling negative pressure at a distal end region of a suction device, comprising: The method includes actuating a button portion of a control element of the suction device to move a valve portion of the control element across a through-hole of the suction device from an open position to a closed position to substantially restrict fluid flow from the distal end region through the valve portion and along the through-hole, whereby the negative pressure at the distal end region of the suction device is substantially reduced but not stopped.

22. 22. The method of claim 21, comprising lifting an object with the distal end region of the suction device when the valve portion is in the closed position.

23. 23. The method of claim 22, wherein the object comprises a medical implant.

24. 24. The method of any of claims 21 to 23, comprising moving the control element from the closed position to a locked position, wherein at least one sealing surface of the valve portion is biased against a seating surface of each of the through-holes, thereby preventing overflow of fluid through the valve portion.

25. 25. The method of claim 24, comprising at least partially removing a user's finger or thumb from the button portion to at least partially uncover an opening in the button portion to allow negative pressure in a distal bore region of the through-hole and upstream of the valve portion to be vented to atmosphere via a vent in the control element that is in fluid communication with the distal bore region when the valve portion is in the locked position.

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