Abstract:
Disclosed is an irrigation system. The irrigation system includes a manual pump and refill. The manual pump can provide pressurized liquid through a tube at an outlet.

Description:
FIELD 
       [0001]    The subject disclosure relates to an irrigation system, and particularly relates to a manually powered irrigation system having a nozzle. 
       BACKGROUND 
       [0002]    This section provides background information related to the present disclosure which is not necessarily prior art. 
         [0003]    During selected procedures, it may be selected to provide a liquid to a specific location. Generally, fluid may be delivered through a tube that may be powered by a pump. Further, the tube may include suction portions to withdraw/remove material and/or irrigation liquid from a site. Selected systems include a Hydrodebrider® pressurized sinus irrigation system sold by Medtronic, Inc. and systems such as those disclosed in U.S. Patent Application Publication Nos. 2009/0270796 and 2011/0009699 and U.S. Pat. Nos. 8,790,301 and 8,206,349. Such systems are disclosed to include a vacuum source and a control to control a vacuum and irrigation. 
       SUMMARY 
       [0004]    This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features. 
         [0005]    According to various embodiments, a manual pump may be fitted with a valve system. The manual pump may include a syringe or other hand-held and/or operated pump mechanism. The valve system may allow for unidirectional or one-directional delivery of a fluid. 
         [0006]    The valve system may include two one-way valves to allow for filling of a syringe barrel during a first movement of a syringe piston and delivery of a liquid from the filled barrel during a second motion of the piston. The valve system, therefore, allows for generally continuous delivery of a fluid from a source to a selected area while connected to a source. 
         [0007]    Delivery of the fluid may be through a nozzle to provide a selected pressure of fluid to an irrigation site. Irrigation sites may include both living an non-living sites. For example, body surfaces, such as nasal and sinus cavities, or work surfaces, such as degreasing. During irrigation, the pressure may assist in loosening or removing a selected material from a selected surface or breaking up large agglomerations of material into smaller portions for removal. 
         [0008]    Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure. 
     
    
     
       DRAWINGS 
         [0009]    The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure. 
           [0010]      FIG. 1  is a plan view of an irrigation assembly; 
           [0011]      FIG. 2  is a detailed end view of an irrigation nozzle; and 
           [0012]      FIG. 3  is a schematic environmental view of an irrigation site. 
       
    
    
       [0013]    Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings. 
       DETAILED DESCRIPTION 
       [0014]    Example embodiments will now be described more fully with reference to the accompanying drawings. 
         [0015]    With initial reference to  FIG. 1 , an irrigation system  20  is illustrated. The irrigation system  20  is generally a manual irrigation system powered by a user that holds a syringe assembly  24  in one or more hands to operate the syringe assembly  24 . The syringe assembly  24  may include a piston head  26  interconnected with a piston rod  28 . The piston rod  28  may include various features such as a thumb whole or loop  30  to assist in operation of the syringe assembly  24  with one hand of a human user. 
         [0016]    The syringe assembly  24  may include various features such as further including finger or digit rings  42  to assist in manipulating the syringe assembly  24 , in addition to the thumb ring  30 , again with one hand of a human user. Further, a connection portion  46  may include connection mechanisms such as a Luer-Lok® syringe connection, twist lock, press fit, or the like. Therefore, a mechanism may be interconnected with the syringe assembly  24  for use of the irrigation assembly  20 . 
         [0017]    As is generally understood by one skilled in the art, the syringe assembly  24  may be operated to fill a syringe barrel  32  by moving the piston head  26  with the piston rod  28  generally in the direction of arrow  36  and may be emptied by moving the piston head  26  with the piston rod  28  generally in the direction of arrow  40 . It is understood, however, that the syringe assembly  24  may also have a self-return or self-priming system. Self-return systems may include a spring (not illustrated) to bias the piston head  26  away from the connection  46  generally in the direction of arrow  36 . The user, to express the material from the syringe, would overcome the biasing force of the spring to express the material and the biasing force would assist in moving or move the piston head away from the connection  46  to refill the syringe barrel. 
         [0018]    Connected with the syringe assembly  24  at the connection region  46  may be a valve assembly  50 . The valve assembly  50  may include the dual check valve 80187 sold by Qosina, having a place of business at Ronkonkoma, N.Y. The valve assembly  50  may include various valve portions, including two one-way valves. The two one-way valves may include a first one-way valve assembly  52  that opens when negative pressure is formed within the valve assembly  50 . Negative pressure may be produced when the piston head  26  moves generally in the direction of allow  36  to allow a flow of material through the one-way valve assembly  52  generally in the direction of arrow  54 . The material may flow generally in the direction of arrow  54  through a tubing  56 . The tubing  56  may be a flexible tubing to connect with a source container  58  holding or containing a volume or liquid, such as an irrigant liquid. 
         [0019]    The source container  58  may be a container, such as an IV bag or other appropriate volume of an irrigation fluid. The irrigation fluid may be a selected material such as saline. The irrigation fluid may further include various therapeutic reagents such as antibacterial, antimicrobial, anti-inflammatory, and wound healing components. 
         [0020]    The tubing  56  may be connected with a connector  60  to a connection receptacle  62  of the irrigant volume container. The connector  60  and the connection  62  can be any appropriate connection members, as is generally understood in the art. The connection of the connector  60  with the connector  62  may generally be an open connection such that fluid will generally flow from the source container  58  through the tubing  56  once the connector  60  is connected with a connection  62 . The one-way valve assembly  52 , however, may control flow of the fluid from the source container  58  to the syringe assembly  24 , including within the barrel  32 . 
         [0021]    Accordingly, as noted above, when the piston head  26  generally moves in the direction of arrow  36 , the irrigant is drawn from the source container  58  through the connection  62  and the connector  60  through the tubing  56  and generally in the direction of arrow  54 . The movement of the piston head  26  in the direction of arrow  36  may cause a negative pressure through the connector  46  to the valve assembly  50  to open the one-way valve  52 . Therefore, the syringe barrel  32  fills with the irrigant fluid. 
         [0022]    Once a selected volume of the irrigant is positioned within the barrel  32 , however, movement of the syringe piston head  26  in the direction of arrow  36  may be ceased. The piston head  26  may then be moved in the direction of arrow  40  to move the piston head  26  generally towards the connector  46  to assist in removing or evacuating the irrigant material from the barrel  32 . 
         [0023]    When the piston head  26  is moved generally in the direction of arrow  40 , the pressure at the valve assembly  50  may be increased. The increased pressure in the valve assembly  50  can close the one-way valve  52  and open a one-way valve assembly  68 . The increased pressure at the one-way valve assembly  68  may cause the one-way valve  68  to open to allow the irrigant to flow from the barrel  32  through the valve assembly  50  and generally in the direction of arrow  70  through an evacuation or irrigant tubing  72 . The irrigation tubing  72  may extend along a selected length and may bend according to a selected configuration. 
         [0024]    The tubing  72  may be formed of a material that may be rigid or bendable. In various embodiments, the tubing  72  may be bent for use and may maintain the selected bent configuration. Alternatively, or in addition thereto, the tubing  72  may only be flexible and a bendable support structure  74  may be positioned at at least a region of the tubing  72  to assist in supporting and holding the tubing  72  in a selected shape. According to various embodiments, the structure  74  may be a malleable tube, such as an aluminum tube, fixed within the tubing  72 . Various embodiments, may also include malleable wires embedded in a wall of the tubing  72 . Further, multiple tubes may be concentrically placed to support a bend. In still further various embodiments, a distal tube may be formed of a second material different from a proximal portion of the tubing  72  that may be malleable. 
         [0025]    The tubing  72  may be bent at a selected radius, such as near a tip  76  to assist in positioning the tip  76  at a selected location. For example, the tip  76  may be selected to be positioned in a sinus cavity, as discussed further herein, and forming a radius or angle near the tip  76  may assist in positioning the tip  76  within the selected sinus. The radius may be supported by the structure  74  that may be different than the material of the tubing  72 . 
         [0026]    With continued reference to  FIG. 1  and additional reference to  FIG. 2 , the tip  76  may be formed to cause a selected shape of a spray that exits the tube  72  and the tip  76 . As illustrated in  FIG. 2 , a detailed view generally along or at the distal tip  76  of the irrigation tube  72  is illustrated. The tip  76  may include a selectively shaped opening  80 . The opening  80  may include a slit that has a first surface  82  and a second surface  84 . The first and second surfaces  82 ,  82  may be angled relative to one another and may include an elongated configuration such that a fan-shaped spray emanates from the tip  76 . The opening  80  may also include sidewalls adjacent to the surfaces  82 ,  84  to further direct the spray. 
         [0027]    At the tip  76 , the first surface  82  may be angled relative to the second surface  84  to form a selected configuration of the spray, as noted above, which may be a fan shape. Further, due to the angle of the surface  84 , the spray may be directional, such as spraying generally at the angle of the surface  84  and away from an axis  88  through the tip  76 . This can allow the tip  76  to be rotated around the axis  88 , such as by rotating the syringe assembly  24 , to select a direction of the spray through the opening  80 . 
         [0028]    Visualization of the direction of the spray may be made by direct endoscopic or direct visual inspection of the spray. Further, a directional marker, such as a radiopaque indicator  90  may be included to indicate a direction of the spray from the opening  80 . For example, as illustrated in  FIG. 2 , a triangle or arrowhead may be the indicator  90  that points towards the direction of the spray. Therefore, a fluoroscopic view may be made to determine the direction of the spray from the opening  80 . 
         [0029]    Further, a cross-sectional area or volume of the opening  80  relative to a cross-sectional area of an opening or lumen through the tubing  72  may be selected at an appropriate ratio of about 1:1 to about 1:10,000, including about 1:2 to about 1:100, including about 1:6. Further, more than one of the tips  76  may be provided on the tubing  72 . Multiple tips or multiple openings on one tip may provide for a spray being directed in a plurality of directions at once. Further, the tips  76  may be selectable or changeable during use. Different tips providing different ratios may be used to provide different spray patterns and/or pressures. Accordingly, A kit may be provided that includes the irrigation system  20  with one or more tips  76 . The tips may be assembled during use. The kit may be provided in a container that allows sterilization of the kit prior to use. The ratio of the volume of the opening  80  relative to cross-sectional area of the lumen can allow for a selected pressure to be provided through the opening  80 . Providing a selected pressure, such as a pressure of about 1 pounds per square inch (PSI) to about 100 PSI may be provided. The selected PSI may assist in a procedure, such as debridement of a region. For example, debridement may include removing a biofilm, breaking an agglomeration, or otherwise providing pressure to an area to assist in removing a selected material or clearing a selected area. 
         [0030]    With continuing reference to  FIGS. 1 and 2  and additional reference to  FIG. 3 , the irrigation assembly  20  may be used to debride or irrigate a selected nasal passage or sinus cavity. As is generally understood by one skilled in the art, a subject, such as a human subject  100  may include or have a first nasal passage  110  or a second nasal passage  112 . Further, the subject  100  may include one or more sinus cavities including schematically illustrated sinus cavities, including maxillary sinuses  114   a  and  114   b  and frontal sinuses  116   a  and  116   b.    
         [0031]    During a procedure, the tip  76  may be introduced through the nasal passage  110  and moved into the maxillary sinus cavity  114   a . The tip  76  may be carried on the tubing  72  and may be manipulated into position via holding and operating the syringe assembly  24 . During use, the user may then move the syringe head  26  generally in the direction of arrow  36  to fill the barrel  32  and then generally in the direction of arrow  40  to express the irrigation material through the tubing  72  and out of the tip  76 . 
         [0032]    When expressing the irrigation material out of the tubing  72  and tip  76 , a spray  120  may be formed as the irrigation fluid impinges upon an internal surface of the maxillary cavity  114   a . It is understood that the tip  76  may be moved through either or both of the nasal passages  110 ,  112  into any of the selected sinus cavities, including either of the maxillary sinuses  114   a  or  114   b , or frontal sinuses  116   a  or  116   b  or other sinuses such as the sphenoid or ethmoid sinuses. Nevertheless, the user may operate the syringe assembly  24  to irrigate the sinus cavities and/or nasal passages. 
         [0033]    During operation, the user may continuously irrigate using a reciprocating action of the piston head  26 . By first moving the piston head  26  generally in the direction of arrow  36 , the barrel  32  may be filled and then expressing material by moving the piston head  26  generally in the direction of arrow  40 . As noted herein, the repeated movement of the piston head  26  in the first direction arrow  36  then the second direction arrow  40  a continuous irrigation may be performed. 
         [0034]    The reciprocating motion of the piston head  26  may be manually operated by the user and may not cause a continuously steady stream (e.g. the continuous flow may be pulsatile) during the emptying of the source container  58 . However, due to the connection of the syringe assembly  24  to the irrigation volume  58  through the tubing  56  and the position of the valve assembly  50 , the source container  58  may be emptied or continuously used until debridement or irrigation is complete or the source container  58  is empty. Therefore, the user need not remove the syringe assembly  24  from the irrigation site to refill the syringe assembly  24  during an irrigation procedure, but may maintain the tip  76  at a selected irrigation position during an entire irrigation procedure while manually operating the syringe assembly  24  during the irrigation procedure. 
         [0035]    It is understood that the irrigation assembly, according to various embodiments, as discussed herein, may be use to irrigate selected surfaces or volumes.  FIG. 3  is merely exemplary of irrigating a surface or cavity within a human subject. It is understood, however, that other cavity within a subject may be irrigated. Further, devices, such as implants or treatment devices, may have the irrigant applied to their surfaces before, during, or after positioning with in a subject. For example, an implant may have its surface irrigated after implantation to assist in removing bacteria, etc. 
         [0036]    Example embodiments are provided so that this disclosure will be thorough, and will fully convey the scope to those who are skilled in the art. Numerous specific details are set forth such as examples of specific components, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, that example embodiments may be embodied in many different forms and that neither should be construed to limit the scope of the disclosure. In some example embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail. 
         [0037]    The foregoing description of the embodiments has been provided for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure. Individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but, where applicable, are interchangeable and can be used in a selected embodiment, even if not specifically shown or described. The same may also be varied in many ways. Such variations are not to be regarded as a departure from the disclosure, and all such modifications are intended to be included within the scope of the disclosure.