The present invention relates to methods and apparatus for irrigating and/or rinsing a subject's nasal cavity. More particularly, the present invention relates to methods and apparatus for irrigating and/or rinsing a subject's nasal cavity by utilizing various features to facilitate such procedures.
Regular implementation of nasal irrigation and/of rinsing of a subject's nasal cavity are generally an effective therapy to relieve symptoms associated with nasal problems such as rhinosinusitis, upper respiratory infections, allergies, etc. Conventional treatments for effecting nasal irrigation have generally included gravity-based and pressure-based devices.
Typical gravity-based devices flow saline into the nasal cavity from a reservoir, such as a Neti pot, into one nostril and out the other nostril while flowing the fluid into the nasal cavity and through the nasal septum. Because these devices utilize gravity to effectuate fluid flow through the nasal cavity, the user must position themselves into an awkward position and must also perform the procedure in an area where the irrigated fluid may be captured or trapped such as in a sink or large container.
Other gravity-based systems have attempted to facilitate nasal irrigation by utilizing hand-held devices which irrigate the nasal cavity under gravity and some suction to draw the fluid through the cavity while collecting the effluent material in a separate capture reservoir. However, such devices require the use of a relatively large irrigation reservoir to hold a sufficient volume of fluid and also require an equally large capture reservoir for containing the effluent material. The resulting device is large and bulky for the user to handle.
Alternative pressure-based devices typically utilize a pump to force saline fluid through the nasal cavity by introducing the fluid into one nostril and out the other nostril. Yet like gravity-based devices, the pressure-based devices require the use of a large volume of irrigation fluid as well as a large capture vessel to contain the effluent material and results in a bulky device.
Moreover, both gravity-based and pressure-based systems irrigate the nasal passages by simply flowing the irrigation fluid uni-directionally through the nasal cavity. One difficulty in effectively treating the nasal cavity is ensuring that all regions of the cavity have been suitably treated as a simple uni-directional flow may not result in complete irrigation of all tissue surfaces, thus simple irrigation through the cavity may not be entirely effective.
Accordingly, there exists a need for devices and methods which are effective yet easy to handle and use for irrigating and /or rinsing the nasal cavity of a subject.
Irrigating and/or rinsing a subject's nasal cavity may be accomplished by utilizing a fluid reservoir which holds a volume of irrigating fluid, such as saline, as well as a capture reservoir for storing the effluent material. The irrigation fluid may be introduced into one nostril and drawn through the nasal cavity, across the nasal septum via the posterior margin and out the other nostril. Although irrigation and/or rinsing of the nasal cavity in particular are described, other bodily cavities may be treated utilizing the devices and methods described herein such as the paranasal cavities, e.g., maxillary sinuses, frontal sinuses, sphenoid sinuses, nasopharynx, etc. A staged treatment procedure which allows for an initial infusion or flushing of irrigation fluid, circulation of the fluid, and subsequent flushing of the effluent from a subject's nasal cavity may be utilized. Other features may incorporate a reversible flow of the irrigation fluid during an irrigation procedure as well as the use of vibration to potentially disrupt debris within the nasal cavity to facilitate the mixing and removal of the debris with the irrigated fluid for removal from the cavity. Additional features may incorporate the use of pulsed fluid flow, e.g., via a peristaltic flow of the irrigation fluid, to facilitate contact between the fluid and debris during fluid circulation, as described in further detail below. Alternatively and/or additionally, the irrigation fluid may also incorporate air or a gas into the fluid flow to create discrete volumes or boluses of pressured fluid to further facilitate thorough irrigation of the nasal cavity.
One variation of a nasal irrigation assembly may be fluidly coupled to a fluid reservoir which may hold a volume of irrigating fluid coupled to the fluid channel. A fluid actuation mechanism, e.g., a fluid pump (such as a reversible peristaltic pump) which is manually or automatically operable, may be integrated with the fluid reservoir and actuatable to urge or force the irrigating fluid from the reservoir and into the fluid channel. While the fluid reservoir may be sized to accommodate any range of irrigating fluid volumes, the reservoir may be sized to hold, e.g.,3 to 20 cc or more of the irrigation fluid. Moreover, the irrigation fluid itself may comprise saline fluid optionally infused with one or more drugs or agents, e.g., steroids, vaso-constrictors, etc. for administering additional treatments to the nasal cavity tissues as well as mild surfactants to break up mucus during irrigation and to help clear nasal passages. Other fluids aside from saline may be utilized as well. Furthermore, the irrigation fluid may also range in concentration to be, e.g., isotonic, hypotonic, hypertonic, etc., as so desired.
A capture reservoir may also be fluidly coupled to the fluid channel for receiving the effluent material during irrigation. An operable valve, e.g., stopcock, may. also be in communication between the reservoir and fluid channel to selectively direct flow either to the reservoir or to circulate through the fluid channel. Additionally, a valve, e.g., uni-directional valve, may also be incorporated along the fluid channel to direct the irrigation fluid flow in a single direction. An additional filter may also be incorporated along the fluid channel on either side of the valve to filter and capture any debris which may be circulating through the fluid channel during fluid irrigation or circulation. Optionally, a heating element may also be integrated into any of the components to warm the irrigation fluid.
With the valve suitably actuated, an initial flush of sterile irrigation fluid may be pumped from the reservoir into the fluid channel and through the first lumen opening for introduction into the subject's nasal cavity to purge the device and nasal cavity of air as well as any large debris and/or viscous mucous from the cavity. The irrigated fluid received from the subject's nostril may pass into the second lumen opening, partly through the fluid channel, and into the capture reservoir such that any large debris and/or viscous mucous may be contained. Additionally, any trapped air or gas may be vented from the nasal cavity, device, and/or the capture reservoir through the vent defined in the reservoir. A relatively small volume of the irrigated fluid, e.g., 3 to 10 cc or more, may be directed via the valve to flow into the capture reservoir for this initial purge. Optionally, an irrigation fluid having a viscosity altered from the viscosity of saline (relatively higher or lower) may be used for the initial pass, e.g., ethanol alcohol solution mixed with saline, glycerin, propylene glycol, etc., to facilitate the clearing of debris and/or mucous as well as to facilitate any deposition of drugs which may be infused with the irrigation fluid. Subsequent irrigation cycles may utilize a fluid having a relatively lower viscosity, if so desired.
After the initial purge, the remaining volume of irrigation fluid within the fluid reservoir, e.g., the remaining 10 to 20 cc or more, may be then introduced into the fluid channel for introduction into and through the nasal cavity. The valve may be actuated to allow flow through the fluid channel while restricting flow into the capture reservoir such that the irrigation fluid cycled through the nasal cavity may be recirculated through the device and back into the nasal cavity to ensure thorough irrigation and/or rinsing. A pumping mechanism may urge or drive the recirculating fluid through the fluid channel and the nasal cavity. A uni-directional valve may ensure that the recirculating fluid flows in a single direction while a filter may capture any debris dislodged from the nasal cavity during the recirculatory flow to ensure that the dislodged debris is prevented from flowing back into the nasal cavity. The filtered fluid may be recirculated through the nasal cavity for one or more passes, e.g. two passes, to thoroughly irrigate and rinse the tissue. Because the irrigation fluid is recirculated, the total volume of fluid needed to effectively irrigate and/or rinse the nasal cavity is greatly reduced from a typical gravity or pressure-based design and allows for the assembly to have a relatively compact form factor for ease of handling.
Once the irrigation fluid has been introduced and recirculated, the valve may be actuated to re-direct the flow from the fluid channel back into the capture reservoir to cease the recirculation of fluid. The recirculating fluid may be accordingly drained to capture any remaining debris and/or mucous and a final purge of air or gas may be optionally introduced into the device and nasal cavity to purge any of the remaining fluid. To introduce the purging air or gas, the fluid reservoir, e.g., may be re-filled with air, or air may be introduced into the system through an alternative valve and this air or gas may then be introduced as a final purging step. Additionally and/or alternatively, along with (or in place of) the purging air or gas another fluid mixture may be introduced. For instance, a fluid mixture containing, e.g., hydrogen peroxide (H2O2), ethanol mixture, or other sterilizing agent, etc., may be introduced during or after fluid circulation to sterilize and to completely purge the nasal cavity as well as the device.
In another variation rather than utilizing a positive-pressure pumping mechanism, a negative-pressure system may be used. An aspiration chamber having the fluid actuation mechanism may be fluidly coupled through the valve to the fluid channel and a fluid reservoir may likewise be fluidly coupled through the valve to the fluid channel.
With the respective valves set in a purging position, the aspiration chamber may be actuated to draw the irrigation fluid from the fluid reservoir through the fluid channel, through the nasal cavity, and directly into the aspiration chamber for an initial purge to remove any large debris and also to purge the system and nasal passages of air. The valves may be set to enable flow through only the fluid channel and the aspiration chamber may be optionally removed. With the pump actuated forcing fluid flow through a bypass lumen and the valves set to allow flow through the fluid channel, the irrigation fluid may be recirculated through the fluid channel, bypass lumen, and into the subject's nasal cavity through the lumen opening and back. One or more filters may be incorporated along the fluid channel to capture any debris and prevent its recirculation through the nasal cavity. Once the recirculating fluid has passed through the nasal cavity for at least one or two (or more) passes, the valves may be reset to a purging position to redirect the fluid flow into the aspiration chamber until all remaining fluid from the system and nasal cavity has been aspirated.
In another variation, a selector control may be actuated either manually by the user or automatically by a controller (such as a processor) integrated into the assembly to control the unidirectional purging flow, recirculating flow through the nasal cavity, and optional final purging step.
In yet another variation, any of the devices described herein may include a mask for temporary placement upon the user's face in proximity to their nose during a treatment to form a seal against the subject's nose and face to capture any fluid leakage which may occur from the nostril-port interface. The mask may incorporate one or more vibrating elements integrated along the mask or assembly which when engaged may vibrate the mask or a portion thereof to transmit vibrations to the underlying tissue or bones, such as the cheek bones, of the subject. These transmitted vibrations may be imparted to disturb any fluids which may be contained within the nasal cavity to cause any debris, such as hardened or thickened mucous, to dislodge from the sinus walls and to mix with the circulating irrigation fluid for flushing out of the nostril and into the capture reservoir. In other variations, a vibrational mechanism may be used to directly transmit vibrations through the irrigation fluid being circulated through the nasal cavity. Such vibrations can comprise a high frequency vibration such as ultrasonic vibrations or even low frequency vibrations, e.g., at a frequency of less than 1000 Hz, to cause the mucous to break down and drain more easily with the circulating irrigation fluid.
In yet another variation, a high-energy radiation source (e.g., having wavelengths between 185 nm to 245 nm such as an ultraviolet light source) may be optionally integrated into the irrigation assembly and positioned within the housing in proximity to the fluid channel such that the light source may irradiate the adjacent fluid channel and the irrigation fluid flowing therethrough.
Additionally and/or alternatively, any of the variations described herein may further comprise an optional valving feature to mix the irrigation fluid with air or a gas introduced into the fluid flow to form discrete volumes for flushing through the device and nasal cavity. This mixture of air (or gas) with irrigation fluid may allow for better disruption of debris within the nasal cavity.
In irrigating and/or rinsing a subject's nasal cavity, any one of several features may be utilized individually and/or in combination to effectuate a thorough irrigation treatment. Generally, one variation of the device may incorporate a fluid reservoir which holds a volume of irrigating fluid, such as saline, as well as a capture reservoir for storing or capturing the effluent material. The irrigation fluid may be introduced into one nostril and drawn through the nasal cavity and out the other nostril. One feature may incorporate a staged treatment procedure which allows for an initial infusion or flushing of irrigation fluid, circulation of the fluid, and subsequent flushing of the effluent from a subject's nasal cavity. Other features may incorporate a reversible flow of the irrigation fluid during an irrigation procedure as well as the use of vibration to potentially disrupt debris within the nasal cavity to facilitate the mixing and removal of the debris with the irrigated fluid for removal from the cavity. Additional features may incorporate the use of a peristaltic flow of the irrigation fluid to facilitate contact between the fluid and debris during fluid circulation to disrupt the debris from adhering to the sinus cavity walls and to mix with the circulating fluid to increase the likelihood that it will be removed from the sinus cavity. Alternatively and/or additionally, the irrigation fluid may also incorporate air or a uas into the fluid flow to create discrete volumes or boluses of pressured fluid to further facilitate thorough irrigation of the nasal cavity.
Turning now to the example shown in
The fluid channel 12 may also be fluidly coupled to a fluid reservoir 26 which may hold a volume of irrigating fluid 28 coupled to fluid channel 12 via a fluid connection 30. A fluid actuation mechanism 46, e.g., a fluid pump which is manually or automatically operable, may be integrated with the fluid reservoir 26 and actuatable to urge or force the irrigating fluid 28 from the reservoir 26 and into fluid channel 12. Although fluid reservoir 26 and mechanism 46 are illustrated as a syringe in this variation, this is merely illustrative of a fluid reservoir which may be pressurized and any number of variations is intended to be included in this disclosure. While the fluid reservoir 26 may be sized to accommodate any range of irrigating fluid volumes, reservoir 26 may be sized in one example to hold, e.g., 3 to 20 cc or more of the irrigation fluid. Moreover, the irrigation fluid itself may comprise saline fluid optionally infused with one or more drugs or agents, e.g., steroids, vaso-constrictors, etc. for administering additional treatments to the nasal cavity tissues as well as mild surfactants to break up mucus during irrigation and to help clear nasal passages. Aside from saline, other fluids may be utilized as well. Furthermore, the irrigation fluid may also range in concentration to be, e.g., isotonic, hypotonic, hypertonic, etc., as so desired. Additionally and/or alternatively, fluids having an altered pH level from that of saline may also be utilized. For example, irrigation fluids having a relatively higher or lower pH level may be utilized in temporarily or permanently inactivating inflammatory proteases.
Aside from the fluid reservoir 26, a capture reservoir 38 may also be fluidly coupled to fluid channel 12 via a fluid connection 40 and may further include an optional vent 44 for displacing any gas or air within the capture reservoir 38 when receiving the effluent material during initial purging and final flushing stages. An operable valve 42, e.g., stopcock, may also be in communication between reservoir 38 and fluid channel 12 to selectively direct flow either to reservoir 38 or to circulate through fluid channel 12. Additionally, a valve 34, e.g., uni-directional valve, may also be incorporated along fluid channel 12 to direct the irrigation fluid flow in a single direction, particularly during recirculation as described in further detail below. An additional filter 36 may also be incorporated along fluid channel 12 on either side of valve 34 to filter and capture any debris which may be circulating through fluid channel 12 during fluid irrigation or circulation. Optionally, a heating element may also be integrated into any of the components to warm the irrigation fluid. For example, a heating element may be incorporated into fluid reservoir 26, connector 30, fluid channel 12, etc. so long as the heating element is in thermal communication with the irrigation fluid.
In use, an example of a staged procedure (e.g., a three-stage procedure) is shown illustratively in
Optionally, an irrigation fluid having a relatively higher viscosity than saline may be used for the initial pass, e.g., ethanol alcohol solution mixed with saline, to facilitate the clearing of debris and/or mucous as well as to facilitate any deposition of drugs which may be infused with the irrigation fluid. Subsequent irrigation cycles may utilize a fluid having a relatively lower viscosity, if so desired.
After the initial purge, the remaining volume of irrigation fluid 60 within fluid reservoir 26, e.g., the remaining 10 to 20 cc or more, may be then introduced into fluid channel 12 for introduction into and through the nasal cavity. Valve 42 may be actuated to allow flow through fluid channel 12 while restricting flow into capture reservoir 38 such that the irrigation fluid cycled through the nasal cavity may be recirculated through the device and back into the nasal cavity to ensure thorough irrigation and/or rinsing, as shown in
Once the irrigation fluid 60 has been introduced and recirculated, valve 42 may be actuated to re-direct the flow from fluid channel 12 back into capture reservoir 38 to cease the recirculation of fluid. The recirculating fluid 64 may be accordingly drained to capture any remaining debris and/or mucous and a final purge of air or gas 66 may be optionally introduced into the device and nasal cavity to purge any of the remaining fluid, as shown in
Another variation which utilizes a single reservoir which may be used as both the fluid reservoir and capture reservoir is shown in the example of
In use, reservoir 27 having the predetermined volume of irrigation fluid may be attached to fluid channel 12. Reservoir 27 may optionally incorporate a filter 35 such that the irrigation fluid 60 urged from reservoir 27 (e.g., via a pump integrated with reservoir 27 or coupled to reservoir 27 as described herein) is filtered and/or the recirculated fluid and/or effluent fluid when captured back in reservoir 27. As shown in
Once the recirculated fluid 64 has been cycled through the device and nasal cavity, e.g., for two or more passes, valve 70 may be actuated again to direct the recirculated fluid 64 back into reservoir 27 which may have been partially or fully emptied of the initial irrigation fluid 60 and as shown in
In another variation rather than utilizing a positive-pressure pumping mechanism, a negative-pressure system may be used, as shown in the example of
With respective valve 70 and 42 set in a purging position, aspiration chamber 76 may be actuated via mechanism 46 to draw the irrigation fluid from fluid reservoir 78 through fluid channel 12, through the nasal cavity, and directly into aspiration chamber 76 for an initial purge to remove any large debris and also to purge the system and nasal passages of air, as shown in
Once the recirculating fluid 88 has passed through the nasal cavity for at least one or two (or more) passes, valve 70 may be reset to a purging position to redirect the fluid flow into aspiration chamber 76, which may be re-attached to fluid channel 12 (if previously removed) prior to resetting valve 70 and prior to purging the fluid channel 12 and nasal cavity, as shown in
Another variation of a nasal irrigation and/or rinsing system is shown in the front view of
In use, the selector control 90 may be actuated either manually by the user or automatically by a controller (such as a processor 93) integrated into the assembly. As shown in the side and top views of
Once the initial purging flow is completed, control 90 may be rotated, e.g., clockwise, relative to stationary attachment 91 to engage active lumen 116 into fluid communication with fluid lumen 92 and fluid reservoir 98 and to also engage bypass lumen 118 with fluid lumen 94 to allow for the recirculating flow through the nasal cavity, as shown in
With completion of the recirculatory fluid flow treatment, control 90 may be actuated again by further rotating, e.g., clockwise, relative to stationary attachment 91 such that no active lumens are engaged with fluid lumens 92, 94, as indicated by the absence of any lumens relative to indication line 110 shown in
Alternatively, rather than further actuating control 90 to the position shown in
In yet another variation, any of the devices described herein may include a mask 130 optionally attached to the assembly 50, as shown in the perspective view of
Additionally and/or alternatively in other variations, one or more vibrating elements may be integrated along the mask 130 or assembly 50 which when engaged may vibrate the mask or a portion thereof to transmit vibrations to the underlying tissue or bones, such as the cheek bones, of the subject. These transmitted vibrations may be imparted to disturb any fluids which may be contained within the nasal cavity to cause any debris, such as hardened or thickened mucous, to dislodge from the sinus walls and to mix with the circulating irrigation fluid for flushing out of the nostril and into the capture reservoir.
In other variations, additionally and/or alternatively, a vibrational mechanism may be used to directly transmit vibrations through the irrigation fluid being circulated through the nasal cavity. Such vibrations can comprise a high frequency vibration such as ultrasonic vibrations or even low frequency vibrations, e.g., at a frequency of less than 1000 Hz, to cause the mucous to break down and drain more easily with the circulating irrigation fluid.
In yet another variation, an irrigation system which may be used for a staged treatment is shown in
Generally, while conventional devices simply flow the irrigation fluid through the nasal cavity, the system herein may be utilized to flow the irrigation fluid through the nasal cavity in a disruptive manner. That is, a pulsatile or vibrational fluid flow may be delivered into and through the nasal cavity in either a rhythmic or synchronized manner or alternatively in a chaotic or turbulent flow pattern where one or more flow parameters, e.g., rate, volume, pressure, direction, etc., can be varied for a given volume of fluid. Such disruptive flow may facilitate penetration of the irrigation fluid through the nasal cavity as well as with removal of any debris or mucous. Moreover, such flow parameters may be controlled via a controller such as a microprocessor or through other mechanical mechanisms, e.g., offset or asymmetric aligned rollers in a peristaltic pumping device, as further described herein.
As illustrated in
As previously mentioned, because the peristaltic pump 82 is completely reversible, fluid flow during the recirculation phase may be urged to flow through the device and nasal cavity in a first direction, as indicated by the first direction of rotation 152 of the pump 82, as shown in
In yet another variation, a high-energy radiation source (e.g., having wavelengths between 185 nm to 245 nm such as an ultraviolet light source 160) may be optionally integrated into the irrigation assembly, as shown in
Additionally and/or alternatively, any of the variations described herein may further comprise an optional feature to mix the irrigation fluid with air or a gas introduced into the fluid flow to form discrete volumes for flushing through the device and nasal cavity. This mixture of air (or gas) with irrigation fluid may allow for better disruption of debris within the nasal cavity. When the irrigation fluid 60 is drawn from the reservoir 78, a connector 172 such as a Y-connector connected to the reservoir 78 and also having an opening 174 to ambient air may draw both the fluid 60 and air 170 simultaneously such that they mix while being drawn through fluid channel 12 and into the nasal cavity, as shown in the variation of
In yet another variation,
Yet another variation is shown schematically in
As pump 186 urges the recirculated irrigation fluid 194 into trap 182, the fluid may exit opening 188 and deposit any debris within reservoir 184 along the separation distance 198. An additional filter 192 may be positioned adjacent to opening 190 to further prevent any debris from entering the fluid channel as the fluid 196 exits trap 182 for entry into the nasal cavity. Trap assembly 180 may also be utilized to dampen the pulsation of the irrigation fluid, if so desired.
Another variation is illustrated schematically in the side view of
Turning now to the filter, repeated passes of fluid during a recirulatory flow through the nasal cavity may cause dislodged debris and mucus to accumulate in the filter. If enough material is accumulated, the filter may eventually become clogged or obstructed to the point that the filter itself disrupts or obstructs the circulation of the irrigation fluid through the device. Accordingly, various mechanisms may be optionally implemented to prevent or inhibit filter obstruction during use of the device.
One example is shown in the side and front views of
Another variation is shown in the cross-sectional side and end views of a cartridge assembly in
In yet another variation, the distributor element 260 may be configured as a singular blade or member which may be rotated, e.g., in a first direction 262 or in an oscillatory motion, over the filter element 212 to disrupt any collected debris, which may be collected in a collection trap 264. As above; distributor element 260 may be actuated on an as-needed, periodic, or continual basis to maintain the irrigation flow through the filter element 212.
The applications of the devices and methods discussed above are not limited to nasal irrigation and/or rinsing but may include any number of further treatment applications. Moreover, such devices and methods may be applied to other treatment sites within the body. Modification of the above-described assemblies and methods for carrying out the invention, combinations between different variations as practicable, and variations of aspects of the invention that are obvious to those of skill in the art are intended to be within the scope of the claims.
This application is a continuation of International Patent Application No. PCT/US2011/023796 filed Feb. 4, 2011 which claims the benefit of U.S. Provisional Patent Application No. 61/303,147 filed on Feb. 10, 2010, the contents of which are incorporated herein by reference in their entirety.
Number | Date | Country | |
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61303147 | Feb 2010 | US |
Number | Date | Country | |
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Parent | PCT/US2011/023796 | Feb 2011 | US |
Child | 13545859 | US |