Abstract:
A hand-held disposable body cavity irrigation device comprises a pump with an inlet and an outlet, a container for lavage fluid fastened removably to said pump, an applicator having an insertion tip, and divided longitudinally into an injection chamber with a first fitting and a drain chamber with a second fitting, and a first tube connecting said outlet to the first fitting wherein the first tube comprises at least one malleable element embedded longitudinally into an elastic wall, said inlet communicates with the lavage fluid within the container, and the drain chamber is disposed predominantly below the injection chamber and has at least one vent beyond the insertion tip.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    The present invention relates to devices for injecting liquid into a body cavity to effect cleaning thereof and, more particularly, a device for irrigation of an external ear canal with lavage fluid. 
         [0002]    Various irrigation devices are known for cleaning human body cavities. For example, such devices are used routinely for cleaning the ears of a patient. Most commonly, a flexible bulb is fitted to a nozzle through which the lavage fluid is discharged into the ear canal of a patient. 
         [0003]    Bulb-type devices have several drawbacks. First, the bulb capacity limits the usage of the device since the bulb contains a relatively small quantity of the lavage fluid and, to fully irrigate a patient&#39;s ear, the bulb has to be refilled a number of times. 
         [0004]    Second, the pressure of the lavage fluid exiting the nozzle and impinging upon the ear canal can not be readily controlled in a reliable manner. This lack of control produces inconsistent results and can in turn, cause pain and injure a patient due to the sensitivity of the tympanic membrane. 
         [0005]    Third, an inconvenience related to collection of the waste fluid discharged from the cavity. In the majority of prior art devices a basin is used to collect the waste fluid. If the basin is not used, then the patient must be irrigated in the vicinity of a sink in order to avoid spillages and further usually require the use of towels, drapes, and other accessories to attend to the discharged lavage fluid. Using either method, the collection of waste fluid from a cleaning procedure is tedious and messy, as well as inefficient. 
         [0006]    There is known an ear irrigator which delivers a stream of water into an ear canal, body cavity or wound in small volume bursts of short duration. The device comprises a bottle containing a volume of water and attached to a hand-held pump actuated by squeezing the trigger, a flexible tube with a splash shield connected to the outlet of the pump, and an end tube connected to the free end of the main conduit tube, the end tube being of reduced outer and inner diameter relative to the flexible tube. The transition from a relatively large internal bore in the flexible tube to a small internal bore in the end tube creates a high velocity flow at the tip and causes the end tube to oscillate during the delivery of the water stream that creates a pulsing water stream relative to any particular location in the ear canal and may be more effective in removing ear wax and debris than a steady stream of water. Although the device is an improvement in terms of the liquid capacity, it does not address the other inadequacies of the bulb-type devices. 
         [0007]    Another known irrigation devices include a pump, connected to a fluid reservoir, and driven by an electric motor. Such devices are capable of pulsatingly or continuously ejecting water from a nozzle opening for a sustained period of time, but do not generally include temperature and pressure indicators for monitoring the temperature and pressure of the water issuing from the nozzle. The use of an electric motor also has a number of inherent disadvantages, including a necessarily maintenance of the device and the noise of the motor, which can be annoying and stressful both for the operator and the person whose ear is being cleaned. 
         [0008]    Fountain-type irrigation devices which are adapted to be connected with a pressure water supply such as at a faucet, on top of having some of the disadvantages of the pump devices, are generally suited for cleaning ears with water only, feature long tubes that necessitate prolonged flashing for stabilizing of the water temperature and inconvenient for the operator, and require pressure relief valves with a separate drain line for dampening of water supply pressure fluctuations. Moreover, the rapid opening and closing of the relief valve can itself create a pulsating flow from the nozzle opening. 
         [0009]    A common problem of using the irrigation devices with continuous supply of the lavage fluid is the waste fluid evacuation. Due to the continuous flow, a protection of patient clothes and the collection of waste fluid from a cleaning procedure are more challenging than with the manual devices. Known in the fountain-type irrigation devices, a vacuum assisted evacuation can work effectively only under certain conditions, which are not sustainable in real settings. 
         [0010]    Another problem long encountered in the field pertains to the temperature of lavage fluid being discharged into the body cavity, especially in those systems that utilize a continuous lavage fluid supply. Lavage fluid which is too hot can create discomfort and in other cases could seriously injure the patient. It has further been determined that lavage fluid which is too cold will not allow optimal cerumen removal. It has been determined that optimal removal is achieved using lavage fluid which is at approximately body temperature. 
         [0011]    Each of the known devices is intended to remove cerumen which has accumulated in the external ear canal. However, each of the known devices involves the possibility of damaging the tympanic membrane, the necessity of professional care, or both. However, with each visit to a doctor, costs are incurred. As well, the time spent by patients in attending at doctors&#39; offices to have cerumen removed is cumulatively significant. 
         [0012]    Therefore it would be desirable to provide an inexpensive, ready and easy to use a body cavity irrigation device capable of holding sufficient volume of lavage fluid, discharging the lavage fluid at a safe and effective pressure, and evacuating reliably waste fluid directly from the cavity. Additionally, it would be desirable if such device included a temperature indicator, which could be used for adjusting and monitoring the temperature of the lavage fluid at the time of use. Further, such device should preferably be safe and convenient for users to self administer the cavity irrigation with no professional supervision. 
       SUMMARY OF THE INVENTION 
       [0013]    The present invention generally focuses on improved body cavity irrigation device in general and ear irrigation device specifically that is equally safe, easy and convenient to use by medical professionals and for self administering. Particularly, in its various embodiments and implementations, the invention provides for a proper supported positioning of the device relative to the cavity, a safe and effective range of discharge velocities of the lavage fluid, a clean and reliable evacuating of the waste fluid directly from the cavity, and the visual indication of safe and usable temperatures of the lavage fluid. Furthermore, the present invention facilitates preventing potential contaminations, saves time of the medical professionals by eliminating unnecessary preparation and clean-up procedures, and may save time and expenses for the prospective patients. Moreover, in its various embodiments and implementations, the invention provides for ecologically friendlier use of resources. 
         [0014]    In general, in one aspect, a body cavity irrigation device comprising: a pump with an inlet and an outlet, a container for lavage fluid fastened removably to said pump, an applicator having an insertion tip, and divided longitudinally into an injection chamber with a first fitting and a drain chamber with a second fitting, and a first tube connecting said outlet to the first fitting wherein the first tube comprises at least one malleable element embedded longitudinally into an elastic wall, said inlet communicates with the lavage fluid within the container, and the drain chamber is disposed predominantly below the injection chamber and has at least one vent beyond the insertion tip. Various embodiments and implementations of this aspect of the invention include the following features: 
         [0015]    The insertion tip is sized to seal against the lavage fluid by conforming to entrance walls of said body cavity and at least part of an external surface of the insertion tip is formed by a compliant element. The applicator further comprises a flow regulating check valve for regulating a velocity of the lavage fluid exiting the insertion tip, said flow regulating check valve at least partially inserted into the first fitting. The flow regulating check valve opens a flow orifice at a first predetermined pressure differential of the lavage fluid across said flow regulating check valve and, after reaching a second predetermined pressure differential of the lavage fluid across the flow regulating check valve, decreases an area of the flow orifice generally proportionally to an increase of a pressure differential of the lavage fluid across the flow regulating check valve. At least one temperature sensor capable of visual representation of temperatures in a range useful for functioning of the lavage fluid wherein said temperature sensor comprises a color changing film applied to a wall of the container. A second tube is attached to the second fitting wherein said second tube is flexible and may connect the second fitting to a waste container and/or to a vacuum source for evacuating the lavage fluid drained from the body cavity. 
     
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         [0016]    In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. 
           [0017]      FIG. 1  depicts a shaded perspective view of the device in relation to a treated ear according to present invention. 
           [0018]      FIG. 2  depicts a perspective view of the device according to present invention. 
           [0019]      FIG. 3A  depicts a detail section view of an embodiment of the device according to present invention. 
           [0020]      FIG. 3B  depicts an exploded view of the applicator shown in  FIG. 3A . 
           [0021]      FIG. 4A  depicts a detail section view of another embodiment of the device according to present invention. 
           [0022]      FIG. 4B  depicts an exploded view of the applicator shown in  FIG. 4A . 
       
    
    
     DETAILED DESCRIPTION 
       [0023]    The following detailed description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the invention, since the scope of the invention is best defined by the appended claims. 
         [0024]    In its various embodiments, the present invention focuses on a device for irrigating a body cavity, particularly an external ear canal. Referring to  FIGS. 1-2 , in one embodiment, an applicator  110  of the device  100  may be inserted into the external ear canal of ear  10 . A feeding tube  120  connects the applicator  110  to a pump  140 , which has a trigger  141  biased outward and a holder  142 . A drain tube  130  connects to the applicator  110  with a first end  131  and to a vacuum line (not shown) with a second end  132  wherein the holder  142  may support a junction of the second end  132  and the vacuum line. A container  150  with a temperature indicator  151  may be fastened to the pump  140 . 
         [0025]    For the purpose of current disclosure, term ‘pump’ means a component comprising an inlet, an outlet, a mechanism that may move a liquid from the inlet to the outlet by creating the vacuum at the inlet and the pressure at the outlet, and, optionally, parts for attaching the feeding tube  120 , the trigger  141 , and the container  150 . Furthermore, it should be understood, the inlet communicates with the container  150  in such a way that about an entire content of the container  150  may be removed by the pump. Moreover, means for attaching the feeding tube  120 , the trigger  141 , and the container  150  as well as various pumps suitable in the context of the current invention are well known in the art. 
         [0026]    Referring to the drawing shown in  FIG. 2 , in one embodiment, the present invention contemplates the applicator  110  comprising an insertion tip  111  and divided longitudinally into an injection chamber  112  terminating as a feeding fitting  113  and a drain chamber  114  terminating as a drain fitting  115 . The feeding tube  120  comprising a malleable metal wire  121  is placed over the feeding fitting  113  and the first end  131  is placed over the drain fitting  115 . 
         [0027]    In another embodiment the present invention, the second end  132  of the drain tube  130  may be terminated in a waste bag instead of the vacuum line. In yet other embodiments of the present invention, the second end  132  of the drain tube  130  may be attachable to a waste container, which may be separate from, attachable to, or a part of the container  150 . Furthermore, the drain tube  130  may comprise a filter for collecting and analyzing solid particles removed from the ear  10 . 
         [0028]    Referring to  FIGS. 3A-3B , in one of embodiments of the present invention, the applicator  110  includes a valve  160  placed into the feeding fitting  113 . The valve  160  comprises a seat  161 , a plunger  162  with an underpressure stopper  165  and an overpressure limiter  166 , and a spring  163 . The seat  161  may be made of elastic material, for example polyurethane, to allow insertion through of the overpressure limiter  166  and has a chamfer  167  for assisting in pulling of the feeding tube  120  over the feeding fitting  113 . Alternatively, the seat  161  may be made from rigid material with a median split to allow assembling of the valve  160 . Relative to other surfaces of the feeding fitting  113 , an end  117  has increased both an outer diameter for holding the feeding tube  120  and an inner diameter for accommodating the seat  161 . Vents  116  may be placed through walls of the drain chamber  114  in an area of transitioning it into the drain fitting  115  beyond the insertion tip  111 , outer surface of which may be essentially a cylinder sized to fit against an inner surface of the external canal of the ear  10 . At least a part of the outer surface of the tip  111  may be formed with an additional layer of compliant material, for example, closed cell plastic foam or a compliant element (not shown) known in the art. The drain fitting  115  comprises a barb  118  for holding the first end  131  of the drain tube  130 , which may be corrugated for combining a lengthwise flexibility with sectional stability. 
         [0029]    Referring to  FIGS. 4A-4B , in another embodiment of the present invention, the applicator  110  includes a valve  170  placed into the feeding fitting  113 . The valve  170  comprises a seat  171 , a plunger  172  with an underpressure stopper  175 , an overpressure limiter  176 , and latches  174  and a spring  173 . The seat  171  with an axial square hole  177  has a chamfer  178  for assisting in pulling of the feeding tube  120  over the feeding fitting  113 . The overpressure limiter  176  may fit in the square hole  177  and the latches  174  may be bendable to allow assembling of the valve  170 . The plunger  172  may have a changing section area along its length providing for changing of the flow resistance depending on position of the plunger  172  in the seat  171 . The increased outer diameter of the end  117  may assist in holding the feeding tube  120  and the inner diameter may accommodate the seat  171 . 
         [0030]    One exemplary embodiment of the present invention functions as follows. Prior to using the device  100  ( FIGS. 1-2 ), the container  150  may be filled with lavage fluid of appropriate temperature and fastened to the pump  140 . Alternatively, the container  150  filled with the lavage fluid may be heated up to the appropriate temperature. The temperature indicator  151  may change its color indicating the appropriate temperature. Pressing the trigger  141  activates the pump  140 , which displaces an amount of the lavage fluid from the container  150  through the feeding tube  120  and the injection chamber  112  of the applicator  110  into the ear  10 . After irrigating the ear  10 , the lavage fluid becomes a waste that drained through the drain chamber  114  of the applicator  110  and the drain tube  130  into the waste container. The wire  121  may allow bending the feeding tube  120  for greater convenience during the procedure and, at same time, supports the applicator  110  maintaining a seal between the external ear canal of the ear  10  and the insertion tip  111  ( FIGS. 3A ,  4 A) of the applicator  110 . 
         [0031]    Referring to  FIGS. 3A-3B , in a particular embodiment of the present invention, the lavage fluid transfers pressure from the outlet of the pump  140  to the valve  160  that pushes the plunger  162  against the spring  163 . Parameters of the spring  163  together with geometry of the valve  160  and the injection chamber  112  define an injection pressure of the lavage fluid. When the pressure exceeds a defined minimum, the plunger  162  moves and allows the lavage fluid to flow around the stopper  165 . With the pressure increasing, the plunger  162  would move further that, at some point, would restrict the flow of the lavage fluid between the seat  161  and the overpressure limiter  165 . Consequently, due to increased resistance in the valve  160 , energy of the lavage fluid discharged from the injection chamber  112  would not exceed certain safe level. The valve  160  would remain open as long as pressure losses across the valve  160  and in the injection chamber  112  together are equal to the pressure upstream of the valve  160 . At extreme rise of the pressure, the overpressure limiter  166  may be pressed against the seat  161  stopping the flow entirely. 
         [0032]    The waste fluid enters the drain chamber  114  and flows along the drain tube  130 . If the drain tube  130  connects to a vacuum source, the vents  116  prevent premature evacuation of the lavage fluid by allowing air from outside to enter the drain tube  130 . In case the drain tube  130  terminates into a closed container or bag, the vents  116  break what otherwise would be a closed loop preventing a pressure buildup in the cavity. 
         [0033]    Referring to  FIGS. 4A-4B , in another embodiment of the present invention, the valve  170  may be applicable to low pressure pumps. Due to square shape of the underpressure stopper  175 , the flow of the lavage fluid around the stopper  175  may be less restricted. Furthermore, due to the overpressure limiter  176  fitting into the square hole  177 , the flow would not be stopped completely but, instead, would depend on a clearance between the limiter  176  and the hole  177 . 
         [0034]    Consequently, the present invention provides the improved body cavity irrigation device that is safe, easy and convenient to use by medical professionals and for self administering. Particularly, the invention provides for a fully recyclable device either disposable entirely or having the container  150  with the temperature indicator  151  reusable. Consequently, the present invention may prevent contaminations, saves time of the medical professionals by eliminating unnecessary preparation and clean-up procedures, and may enable self serving for the prospective patients. 
         [0035]    While several inventive embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the function and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the inventive teachings is/are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto; inventive embodiments may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the inventive scope of the present disclosure. 
         [0036]    Accordingly, as indicated above, the foregoing embodiments of the invention are examples and can be varied in many ways. Such present or future variations are not to be regarded as a departure from the spirit and scope of the invention, and all such modifications as would be apparent to one skilled in the art are intended to be included within the scope of the following claims. 
         [0037]    All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms. 
         [0038]    The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.” 
         [0039]    The phrase “and/or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with “and/or” should be construed in the same fashion, i.e., “one or more” of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the “and/or” clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to “A and/or B”, when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc. 
         [0040]    As used herein in the specification and in the claims, “or” should be understood to have the same meaning as “and/or” as defined above. For example, when separating items in a list, “or” or “and/or” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of” or “exactly one of,” or, when used in the claims, “consisting of,” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e. “one or the other but not both”) when preceded by terms of exclusivity, such as “either,” “one of,” “only one of,” or “exactly one of.” “Consisting essentially of,” when used in the claims, shall have its ordinary meaning as used in the field of patent law. 
         [0041]    As used herein, the term “about” refers to a ±10% variation from the nominal value. It is to be understood that such a variation is always included in any given value provided herein, whether or not it is specifically referred to. 
         [0042]    As used herein in the specification and in the claims, the phrase “at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, “at least one of A and B” (or, equivalently, “at least one of A or B,” or, equivalently “at least one of A and/or B”) can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc. It should also be understood that, unless clearly indicated to the contrary, in any methods claimed herein that include more than one step or act, the order of the steps or acts of the method is not necessarily limited to the order in which the steps or acts of the method are recited. In the claims, as well as in the specification above, all transitional phrases such as “comprising,” “including,” “carrying,” “having,” “containing,” “involving,” “holding,” “composed of,” and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases “consisting of” and “consisting essentially of” shall be closed or semi-closed transitional phrases, respectively