Abstract:
A cleansing system for the intestine of a patient includes a pumping system adapted to provide pulses of a cleansing fluid at a controlled rate and an annular fluid channel in fluid communication with the pumping system. The annular fluid channel serves as a fluid conduit between the body cavity to be cleansed and the exterior of the body. A delivery system includes a nozzle assembly, the nozzle assembly having at least two lumens through which the cleansing fluid exits the nozzle assembly, the at least two lumens being arranged at an angle relative to the annular fluid channel.

Description:
CROSS REFERENCE TO RELATED APPLICATION  
       [0001]    This application claims the benefit of U.S. Provisional application, Ser. No. 60/309,828, filed Aug. 3, 2001. 
     
    
     
       FIELD OF THE INVENTION  
         [0002]    The present invention relates generally to a system and method for cleansing An internal body cavity, and, more particularly, to a system for a irrigating a colon through a to remove fecal material.  
         BACKGROUND OF INVENTION  
         [0003]    It is well known that individuals having surgically created stomas have some special needs associated with evacuation of bowel contents through the stoma. The need for a gentle irrigation method that aggressively breaks up intestinal contents without damaging the fragile intestinal lining has prevented prior devices from being able to successfully and safely facilitate rapid bowl evacuation. Irrigation, especially on a repeated basis, can compromise mucous linings, resulting in actinic changes to mucous membrane tissue. Use of known systems for irrigation of a body cavity, typically a colon, takes a long time, which can be very disruptive of the user&#39;s life-style. It is therefore desirable to provide a system that produces gentle irrigation, while at the same time permitting aggressive break up of the matter to be removed.  
           [0004]    Attempts to develop systems that are considered to be gentle on tissue typically consist of gravity feed bags with a single lumen and steady flow rate nozzle. These systems are very slow and generally used by caregivers, rather than by the patient for irrigation.  
           [0005]    A known electromechanical system, Pulsed Irrigation and Evacuation (PIE), pumps a very large volume of water (such as about 11.5—to about 19 liters) at a flow rate of two to three liters per minute. The water is pumped into the colon through a specula inserted into the rectum or stoma. The water is pumped in in aliquots (25—1—ml) that repeatedly fill and empty the colon at a very rapid rate (e.g. one to four second cycles). This system is far too aggressive to be used on a regular basis, except in sever cases of chronic bowel impaction, where alternatives are limited. These cases include patients with chronic neurogenic bowel due to spinal chord injury or disease. Thus, the PIE system is too aggressive for widespread use, and is limited to cases where other, less aggressive or less invasive alternatives do not exist. The present invention provides a mechanism for addressing the above problems.  
         SUMMARY OF INVENTION  
         [0006]    An aspect of the present invention, briefly, is a cleansing system for the intestine of a patient. The system includes a pumping system adapted to provide pulses of a cleansing fluid at a controlled rate and an annular fluid channel in fluid communication with the pumping system. The annular fluid channel serves as a fluid conduit between the body cavity to be cleansed and the exterior of the body. A delivery system includes a nozzle assembly, the nozzle assembly having at least two lumens through which the cleansing fluid exits the nozzle assembly, the at least two lumens being arranged at an angle relative to the annular fluid channel.  
           [0007]    Another aspect of the present invention is to provide a nozzle assembly comprising a nozzle body housing a nozzle body cavity; an inlet port in fluid communication with the nozzle body cavity; an annular fluid channel in fluid communication with the nozzle body cavity; and a nozzle tip having at least two lumens in fluid communication with the fluid channel.  
           [0008]    A further aspect of the present invention is a method for cleansing a stoma comprising providing a cleansing fluid stream to a nozzle assembly, the nozzle assembly having a central axis; pulsing the cleansing fluid stream; and discharging the pulsed fluid stream from the nozzle assembly through at least two lumens at an angle to the axis of the nozzle.  
           [0009]    These and other aspects and advantages of the invention will be in part apparent and in part pointed out herein below. These are merely illustrative aspects of the present invention and should not be deemed an all-inclusive listing of the innumerable aspects associated with the present invention. 
       
    
    
     BRIEF DESCRIPTION OF DRAWINGS  
       [0010]    [0010]FIG. 1 is a perspective view of the nozzle assembly of the present invention.  
         [0011]    [0011]FIG. 2 is a cross-sectional view taken along line  2 - 2  of FIG. 1.  
         [0012]    [0012]FIG. 3 is a perspective view of the interior of transition hub of the nozzle assembly of FIG. 1.  
         [0013]    [0013]FIG. 4 is a perspective view of the exterior of the transition hub of FIG. 3.  
         [0014]    [0014]FIG. 5 is a perspective view of the interior of the hubcap of the nozzle assembly of FIG. 1.  
         [0015]    [0015]FIG. 6 is a perspective view of the exterior of the hubcap of FIG. 5.  
         [0016]    [0016]FIG. 7 is a perspective view of the distal end of the nozzle assembly of FIG. 1 illustrating an embodiment having three lumens.  
         [0017]    [0017]FIG. 8 is a perspective view of the distal end of the nozzle assembly of FIG. 1 illustrating an embodiment having two lumens.  
         [0018]    [0018]FIG. 9 is a perspective view of the distal end of the nozzle assembly of FIG. 1 illustrating an embodiment having four lumens.  
         [0019]    [0019]FIG. 10 is a cross-sectional view illustrating the angular projection of the lumen in a preferred embodiment.  
         [0020]    [0020]FIG. 11 is a perspective view of the irrigation tubing assembly of the present invention.  
         [0021]    [0021]FIG. 12 is an exploded view of the irrigation tubing assembly of FIG. 11.  
         [0022]    [0022]FIG. 13 is a cross-sectional view along line  13 - 13  of FIG. 11. 
     
    
     DETAILED DESCRIPTION  
       [0023]    The present invention is a cleansing system method and apparatus for irrigation of a cavity for the removal of solid and colloidal matter. This invention has utility to a wide variety of industrial, medical and cosmetic applications. Without straying from the broad intent of this invention, a medical application of the technology will be used for illustration.  
         [0024]    A nozzle assembly, generally designated  10 , is shown in FIGS. 1 and 2. Nozzle assembly  10  comprises the main component of a delivery system. Nozzle assembly  10  is connected to a pumping system, not shown, by a polyethylene tube,  12 . Assembly  10  further includes a transition hubcap  14  and a transition hub  16 , shown in more detail in FIGS. 3 through 6, discussed below. Inner and outer nozzle tubes  18 ,  20  respectively, nozzle tip  22  and location collar  24  complete the basic nozzle assembly  10 .  
         [0025]    [0025]FIGS. 3 and 4 illustrate the transition hub  16  in detail. Transition hub  16  includes a central aperture  26 , threaded screw acceptors  28  and  30  and a shoulder  32 . FIGS. 5 and 6 illustrate transition hubcap  14 , including a central aperture  34  and associated projecting shoulder  35 , and screw apertures  36  and  38 . Transition hubcap  14  further includes a cleansing fluid inlet port  42 , an opposing projection  40 , and a shoulder  44 .  
         [0026]    Nozzle tip  22  includes a front face  48 , an inner projecting portion  52  and an outer projecting portion  50 , best seen in FIGS. 7 through 10. A variety of nozzle assemblies have been devised that demonstrate varying levels of performance and can be selected from for use, depending upon the particular application. In a first embodiment, illustrated in FIG. 7, the front face  48  includes three apertures, or lumens  54 ,  56  and  58 , formed as a result of cutting or machining fluid lumens in the nozzle body. The angle of the lumens relative the axis of the nozzle tubes  18 ,  20 , is shown in FIG. 10. This angle results in discharge of the fluid stream from nozzle tip  22  at a preferred 60° angle relative to the axis of the nozzle tubes  18 ,  20 . An acceptable range for the angle of the discharge of fluid stream relative to the axis of the nozzle tubes is within about 30° to about 60°. The purpose of this angle is to impart a swirling action to the fluid as it exits the nozzle assembly, and may be varied depending on the particular application. The fluid discharging lumens are fed pulses intermittently in sequence or simultaneously, as preferred. This provides a swirling (“vortex”) action that imparts a shearing action to the matter to be broken up, which causes it to break into clumps. Elements which are particularly critical in creating this vortex effect are: 1) the angulation of the orifices, combined with 2) pulsatile (sequential) flow and 3) a plurality of angled lumens and 4) the energy of the fluid streams. The intermittent action of the pulse provides a “jack hammer” action to further break up the clumps. Similarly, with only simultaneous flow out of the same nozzle design there is created only the “jack hammer” action, which has not proven to be as effective in breaking up clumps if all other parameters (i.e. orifice angle, number of orifices and energy of fluid streams) remain constant.  
         [0027]    Another factor which importantly affects the effectiveness of the fluid stream in breaking up fecal clumps is the size of the lumen orifices. In order for the proper nozzle stream velocity to be obtained the orifices should be in the range of about 1.0 mm to about 0.5 mm in diameter. The overall construction of the transition hub and hubcap (the “manifold” system) is designed to provide equivalent flow out of each orifice. The integration of the nozzle with the manifold is constructed to provide such equivalent flow.  
         [0028]    In an alternative embodiment, this nozzle assembly may be fitted with an additional lumen to provide access to the body cavity into which the nozzle is placed for the purpose of facilitating the monitoring pressure or temperature. Particularly the monitoring of pressure within the body cavity as necessary for safety reasons, to prevent the possible rupture of the body cavity.  
         [0029]    In another embodiment, illustrated in FIG. 8, front face  148  includes two apertures, or lumens,  154 ,  156 , located opposite each other on the periphery of the nozzle tube. These are fed fluid by the pumping system in either alternating intermittent or simultaneous pulses. Use of this nozzle permits matter to be broken up by “batting” it back and forth with the pulses of fluid. In an alternate embodiment, not shown, this nozzle assembly may also include a lumen to provide access to the body cavity into which the nozzle is placed for the purpose of facilitating the monitoring pressure or temperature, as described above.  
         [0030]    In yet another embodiment, illustrated in FIG. 9, front face  248  includes four apertures or lumens  254 ,  256 ,  258  and  260  equally spaced apart around the periphery of the nozzle exit. This nozzle configuration permits aggressive pulsating application of fluid to permit effective break up of the contents of a body cavity without damage to the neighboring tissue. In an alternative embodiment, not shown, the nozzles are preferably arranged in two pairs, each pair being operated in sequence with the opposite pair. The first pair imparts a clockwise swirl to the fluid, while the second pair imparts a counterclockwise flow to the fluid. The resultant action of operating these pairs of pulsejets in and out of phase sequence is to impart additional shear to the target matter resulting in rapid breakup of the target material. This assembly can also be fitted with pressure/temperature sensing/communicating lumens and a central drain tube as in the other nozzle assemblies. Other constructions and variation of the described nozzles and pumping systems can be conceived which are considered to be within the scope of the invention, such as varying the number of lumens in each set.  
         [0031]    As is best seen in the cross-sectional view FIG. 2, the irrigation tube  12  is connected to transition hubcap  14  through projection  40 . Transition hub  16  and hubcap  14  are attached to each other along shoulders  32  and  44 , respectively, by a silicon seal, not shown, and are held in place by screws extending through screw apertures  36 ,  38  into screw acceptors  28 ,  30 . Transition hub  16  and hubcap  14  form a nozzle body that houses a cavity  44 , the cavity being is in fluid communication with irrigation tubing  12  through projection  40 .  
         [0032]    Central apertures  26 ,  34  accept the inner nozzle tube  18 , which is open to the atmosphere through central aperture  34 . The interior of inner nozzle tube  18  and central aperture  34  may be adapted to provide a relatively large central drain hole in the middle of the nozzle assembly that can be gravity fed, pressure fed or vacuum evacuated, as desired. The purpose of such adaptation is to drain the matter broken up by the nozzle along with the irrigation fluid from the body cavity. Outer nozzle tube is located coaxially around inner nozzle tube, and is sealed at the projecting shoulder  35  of hubcap  14 . The coaxial arrangement of inner and outer nozzle tubes  18 ,  20  forms an annular space  46 , that is in fluid communication with cavity  44 . Nozzle tubes  18 ,  20  are connected to nozzle tip projecting portion  50 , seen in FIG. 10, by any suitable means, for example by silver solder bonding when the components are formed from metal.  
         [0033]    In operation, a cleansing fluid stream is provided to the nozzle assembly through irrigation tubing  12  and into cavity  46  through projection  40 . The fluid fills cavity  46  and is then forced into annular flow channel  48  and discharged through nozzle tip lumens  54 ,  56 ,  58 . This nozzle system also provides for the draining of the irrigated area through a relatively large drain tube that can be inserted into inner tube  18  through central aperture  34 . The drain tube can be left open or intermittently closed as conditions warrant.  
         [0034]    Attached downstream of irrigation tubing  12  is an irrigation tubing assembly generally designated  50 , shown in FIGS. 11 through 13. Tubing assembly  50  allows the internal pressure to be monitored in order to detect flow blockage or leakage.  
         [0035]    Tubing  52  is attached to connector  54 , pressure sensor housing  56 , connectors  58 ,  60 , circuit board  62  and pressure sensor  64 . The electronic pressure monitor and associated circuit board may be of any conventional design, as is well known by those in the art.  
         [0036]    Nozzle assembly  10  is connected to a pumping system, not shown, through irrigation tubing assembly  50 . In one embodiment, the new system utilizes a peristaltic pumping mechanism, which insures hygienic fluid delivery. This system may provide a motor controller capable of on/off temperature control of the pump mechanism and an internal pressure monitoring system for pump flow blockage or leakage detection. This monitoring system may be coupled with an intra-lumenal pressure sensor referenced to atmospheric pressure for the purpose of monitoring the anatomical cavity pressures associated with the nozzle portion of the device. An example of this type of pumping system is described in U.S. Pat. Ser. No. 09/362,638, filed Jul. 28, 1999.  
         [0037]    Suitable pumping systems provide for independent adjustment of pressure and flow rate as well as adjustment of pulse rate. Other adjustments may include flow rate, pulse duration, pulse volume, total volume, time between pulses or dwell time. Preset parameters may include pressure of fluid delivery, fluid velocity as dictated by number, size and orifice geometry of flow lumens at any given flow rate, and temperature of liquid being delivered.  
         [0038]    An alternate embodiment of the pumping system generates fluid pressure, which is stored in a bladder type tank. In this case the pump is controlled by an adjustable pressure-sensing switch. The fluid is directed from the bladder storage tank to a motor operated pulsing mechanism. One embodiment includes a series of cam operated valves, the inputs of which are connected by a fluid bus to the bladder tank. The output from each valve is independently directed to the fluid delivery nozzle assembly through separate tubes. The duty cycle of each pulse is controlled by a combination of the cam design and the location of the valves relative to the cam. One embodiment has two separate cams and sets of valves, provided to allow the use of any of the nozzle assemblies. The cams of this embodiment are motor-operated with a motor the speed of which is user controllable. This embodiment also includes a tachometer to measure and display the rotational speed of the cam, thus allowing the user to precisely adjust the speed of the pulses. An additional feature is the ability to provide a steady flow to all of the fluid conduits simultaneously. Additionally, this embodiment also provides the ability to have a user-selectable off-dwell period during which no pumping occurs.  
         [0039]    While specific embodiments have been shown and described, many variations are possible. Additional variations within the scope of the invention are as follows. Nozzle bodies can be formed of rigid fabrication or flexible material fabrication, or combinations thereof to achieve conformance to passages (such as a stoma tract) used for nozzle insertion, drain configurations and fluid lumen geometry. Fluid lumens may be of separate tubing configurations, further defined as a nozzle by jacketing, joining or insert molding such tubing sections into nozzle forms.  
         [0040]    Additionally, the nozzle body can be integral to a catheter, stent or port structure (see, e.g., U.S. Pat. No. 6,033,390) wherein the catheter, stent or port provides a permanents or semi-permanent fluid communication between the body cavity and the atmosphere and is connected to the pumping device via the irrigation set when it is desired to irrigate the body cavity.  
         [0041]    Nozzle orifices have been defined as being formed as a result of cutting or machining fluid lumens in a nozzle body material and exposing lumen openings for fluid escapement. However, lumens may also be formed from separate components inserted into nozzle lumens to effect a defined orifice and pattern of fluid escapement. Such orifice articles are easily built in plastics and metals.  
         [0042]    Pump sequences can include the continuous or intermittent delivery of fluids with uninterrupted drain flow, periodic drain flow, or no drain flow until delivery of fluids is complete. Dwell periods may be utilized for further dissolution and wetting of effected masses at any stage of the pump sequence wherein pulsation or supply flow is not occurring.  
         [0043]    While suitable materials for constructing the present invention have been disclosed, the components may be made of any suitable, medically acceptable material.  
         [0044]    In view of the foregoing, it will be seen that the several aspects of the invention are achieved and other advantages are attained. Thus, there has been shown and described several embodiments of a system a system and method for cleaning a stoma, which system and method fulfill all of the aspects and advantages sought therefore. As is evident from the foregoing description, certain aspects of the present invention are not limited by the particular details of the examples illustrated herein, and it is therefore contemplated that many changes, modifications, variations and other uses and applications of the present invention, including equivalents thereof, will become apparent to those skilled in the art after considering this specification and the accompanying figures. All such changes, modifications, various and other uses and applications which do not depart from the spirit and scope of the invention are deemed to be covered by the invention which is limited only by the claims which follow.