Abstract:
A Foley type catheter of the type including an elongated flexible tube and an inflation lumen, the distal end of the tube being provided with a membrane that is inflated into a balloon by fluid passage though the lumen, wherein to retain the distal end interiorly of a bladder, and a drainage eye, wherein to enable the catheter to drain urine therefrom. The proximal end of the tube is provided with a fluid control valve and a fluid pump, each hand operated as desired. The pump is in the form of a squeeze bulb and/or aspirator and adapted to deform to supply and/or withdraw fluid into and from the lumen and selectively inflate/deflate the membrane. In one embodiment, the pump is in the shape of a pleated bellows that is axially collapsed and end walls forced together and into a suction cup like retaining engagement, and a coil spring acts to restore the shape.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     This Application claims the benefit of U.S. Provisional Application No. 60/849,667, filed Oct. 5, 2006, the disclosure of which is incorporated herein in its entirety. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     1. Field of the Invention  
         [0003]     The present invention relates to a Foley type catheter wherein the distal end of a flexible tube is provided with an inflatable balloon to retain the distal end interiorly of a bladder and enable the catheter to drain urine therefrom, and more particularly, to a such a catheter wherein the proximal end is provided with a valve device and squeeze bulb and/or aspirator pump, each hand operated, to selectively inflate and deflate the balloon, respectively, to retain the distal end interiorly of the bladder or other organ and permit removal of the distal end therefrom.  
         [0004]     2. Description of the Prior Art  
         [0005]     Balloon catheters often have a flexible shaft, including a tubular basic body with a distal end and a proximal end, a lumen extending between the ends, as well as a balloon affixed to the shaft near the distal end that is connected with the lumen. Such a basic balloon catheter is generally known, whereby the dimensions of the balloon and the tubular basic body are selected such that the balloon catheter can carry out a therapeutic treatment.  
         [0006]     For example, a Foley catheter drains urine from the bladder. In operation, the balloon end of the tube is inserted into the bladder, whereupon the balloon must be inflated. Typically, to accomplish this, a medical worker fills a syringe with a measured quantity of fluid and injects this fluid into the lumen. The fluid inflates the balloon and the balloon retains the distal end inside the bladder.  
         [0007]     Desirably the catheter would enable a homebound user, or caregiver, the ability to inflate the catheter without the need for a special syringe. Additionally, a catheter should not require the need of a caregiver filling a syringe with a measured supply of inflation fluid.  
         [0008]     Desirably a catheter would be self-contained and enable a homebound user, or caregiver, the ability to deflate and reinflate the catheter should a homebound need arise for removal and reinsertion of the catheter.  
         [0009]     Various catheter arrangements have been proposed, such as illustrated in U.S. Pat. Nos. 1,334,237; 2,032,859; 3,211,150; 3,275,001; 3,401,698; 3,818,903; 3,841,319; 4,101,342; 4,598,707; 4,614,188; 5,342,304; and 6,193,680.  
         [0010]     These arrangements are listed in recognition of the duty of disclosure of related subject matter, which may be relevant, under 37 CFR 1.56.  
         [0011]     While the arrangements shown in each of these patents is believed to have provided a solution to a specific problem there described, the field is always desirous of improvements in the art and it is to that need that the present invention is drawn.  
         [0012]     An object of the present invention is the provision of a Foley catheter that includes an arrangement wherein a specially configured valve is combined with a hand operated squeeze bulb and/or aspirator pump to introduce or withdraw saline or other fluid solution into and from inflating relation with a catheter balloon.  
         [0013]     Another object of this invention is the provision of a catheter wherein a squeeze bulb and/or aspirator pump or the like snaps into place with a sealing valve to enable inflation as well as deflation of the catheter.  
         [0014]     Yet another object of this invention is the provision in a catheter a manually controlled fluid control valve in combination with an aspirator pump, the pump being a pleated accordion type of bellows that is axially collapsible/expandible.  
         [0015]     Another object of this invention is the provision of a coil spring in the fluid reservoir of a pleated accordion bellows aspirator pump, the spring and bellows compressing axially to introduce balloon inflating liquid into the catheter lumen and expanding to assist in withdrawal of the balloon inflating liquid.  
         [0016]     Yet another object of this invention is provision of a simple balloon catheter apparatus, the balloon of which being capable of being inflated and/or deflated by the user in situ, such as at home, and without the need for medical caregivers.  
       SUMMARY OF THE INVENTION  
       [0017]     According to this invention, there is provided a balloon catheter for performing a medical treatment on a patient, comprising:  
         [0018]     a flexible catheter shaft, with a tubular basic body having distal and proximal ends, and defining an inflation lumen extending between the ends; the proximal end defining a drain funnel;  
         [0019]     a balloon affixed to the catheter shaft near the distal end, such that the balloon communicates with the inflation lumen; the balloon having an inflated state and a deflated state;  
         [0020]     a squeeze bulb having an outlet stub and a reservoir for discharging inflation fluid stored in the reservoir; and  
         [0021]     a valve connected to the distal end, said valve connecting to the outlet stub of the squeeze bulb and communicating balloon inflating fluid from the reservoir to the inflation lumen, said valve including a valve plate having a central opening and selectively movable between a closed first position and an open second position; such that the valve plate in the closed position moves the plate opening into a position that prevents fluid flow from the proximal end through the inflation lumen and to the balloon, and in the open position moves the plate opening into a position that permits fluid flow to selectively inflate or deflate the balloon.  
         [0022]     According to a preferred embodiment, the valve includes  
         [0023]     a housing, said housing having opposed pairs of first and second endwalls, respectively, and an interior chamber, and  
         [0024]     a supply tube having first and second ends, and wherein  
         [0025]     said valve plate is movable in a first direction between said first end walls;  
         [0026]     said catheter shaft and supply tube are connected to one and the other of said second end walls and disposed on an axis transverse to said first direction,  
         [0027]     the proximal end said catheter shaft is disposed in said interior chamber and in juxtaposed relation to said valve plate,  
         [0028]     the first end of said supply tube is disposed in said interior chamber and in juxtaposed relation with said valve plate, and  
         [0029]     the second end of said supply tube is connected to the outlet stub of said squeeze bulb.  
         [0030]     According to this invention, the squeeze bulb may comprise an aspirator pump, adapted to collapse, when supplying inflation liquid to inflate a membrane into balloon shape, and then, substantially simultaneously, expand and snap back into its original shape, sucking balloon inflating liquids outwardly and deflating the balloon.  
         [0031]     In a particular aspect, in another preferred embodiment, a catheter assembly, comprising  
         [0032]     a catheter body having a lumen extending from a proximal end thereof through at least a portion of the catheter body, the catheter body being provided with a balloon secured to an exterior surface thereof and expandible between a relaxed state and an expanded state in response to a positive fluid pressure between the exterior and the interior of the lumen, a balloon inflation aperture fluidly interconnecting the lumen and the interior of the balloon, and a fluid discharge aperture for discharging fluid from the lumen,  
         [0033]     a fluid regulating valve provided with an inlet and an outlet and a manually operable closure member, the outlet fluidly connected to the inflation aperture and the closure member mounted for movement between open and closed positions, respectively, for permitting and preventing fluid to pass between the inlet and the outlet, and  
         [0034]     a manually operable aspirator pump fluidly connected to the inlet, said aspirator comprising a generally cylindrical bellows of the pleated type and defining a variable hollow chamber.  
         [0035]     According to this preferred embodiment, a coil spring is mounted in the chamber for biasing the opposite ends of the bellows in opposite directions.  
         [0036]     Also and according to this preferred embodiment, the aspirator pump includes opposite end walls that form, at least in part, mating end faces, which are sealingly mated with one another and form a suction cup like retention with one another when manually pressed together and the valve is in the closed position.  
         [0037]     Further, the aspirator pump may comprise a ball-shaped squeeze bulb.  
         [0038]     Depending on the application, the squeeze bulb and/or aspirator pump is removably and/or non-removably connected, at least in part, to the supply tube and/or the control valve.  
         [0039]     Preferably, the material of the squeeze bulb and/or aspirator pump is comprised of a material that is impermeable to liquids, and resilient and flexible, such as provided by a self-restoring rubber and/or like elastomer, which will operate to restore the deformed member back into an original undeformed shape.  
         [0040]     Preferably, the valve housing is comprised of a material that is impermeable to liquids, and the valve plate is planar and movable between and in generally parallel relation to the first end walls and between said first and second positions by a hand operated pushing motion.  
         [0041]     The present invention will be more clearly understood with reference to the accompanying drawings and to the following Detailed Description, in which like reference numerals refer to like parts and where: 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0042]      FIG. 1  is an exploded side view, partially in section, of a balloon catheter according to the present invention;  
         [0043]      FIG. 2  is a section view of a squeeze bulb and fluid control valve of the catheter according to this invention, the control valve being in a closed position for preventing flow from or into a fluid reservoir of the squeeze bulb;  
         [0044]      FIG. 3  is a section view of the squeeze bulb and control valve of  FIG. 2 , the valve being in the open position for permitting flow from or into the fluid reservoir of the squeeze bulb;  
         [0045]      FIG. 4  is a side view, partially broken away and in section, of an alternate embodiment of a squeeze bulb, in the form of an aspirator pump, used as a suction device with the control valve herein; and  
         [0046]      FIGS. 5 and 6  are side views, partially broken away and in section, of an alternate embodiment of an aspirator pump used with the control valve herein, with  FIG. 5  showing the aspirator pump in an extended state, such as prior to discharging inflating fluid from a fluid reservoir thereof into the balloon, and  FIG. 6  showing the aspirator pump in a compressed state, such as following discharge of balloon inflating fluid from the reservoir thereof. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0047]     Referring to the drawings,  FIG. 1  shows a balloon catheter system, generally indicated by the number  10 . The balloon catheter system  10  is a conventional Foley-type catheter and comprises a relatively long and flexible tubular shaft  12  having a distal end or tip  14 , a proximal end  16 , a pair of drainage eyes  18  and an inflation port  20  proximate to the tip, a drainage funnel  22 , a membrane  24  which is inflatable into a retention balloon  58 , and a side conduit or arm  26 . A drainage lumen  28  extends from the drainage eyes  18  to the funnel  22  and a small inflation lumen  30  extends from the inflation port  20  to the side arm  26 .  
         [0048]     As shown the balloon forming membrane  24  engirdles the catheter shaft  12  and is in covering relation about and with the inflation port  20 . The membrane  24  is of a resilient material capable of expanding outwardly, when placed under fluid pressure, and form into a balloon. Conversely, the material of the membrane  24  will restore into its close form fitting relation with the shaft  12  when the fluid pressure is removed.  
         [0049]     In the balloon catheter according to an embodiment of the present invention, a controllable closing device or control valve  32  and a squeeze bulb  34  having a reservoir filled with fluid to inflate the membrane  24  are integrated into the side arm  26 . The control valve  32  can selectively close off, or open, the inflation lumen  30  Such closing can have at least two functions. First, it can provide an opportunity to remove or purge air present inside the balloon catheter prior to use, and then close off the balloon catheter. Second, it becomes possible to maintain the pressure in that section of the lumen connected to the balloon and in the balloon itself.  
         [0050]     In a preferred embodiment, the closing device or control valve  32  is at the proximal end  16  of the catheter shaft  12  and connected in sealed relation thereto. The control valve  32  includes a housing  36 , made of a material impermeable to fluids and having an interior chamber  38 , a supply tube  40  having an inlet  42  and outlet  44 , respectively, exterior to and interior of the chamber  38 , and a generally planar closure or valve plate  46  having a circular shaped central opening  48 . The interior diameters of the tubes  12  and  40  and the diameter of the central opening  48  are substantially the same. Further, the axes of the tubes  12  and  40  are coaxially aligned with one another and adapted to be placed in coaxial relation with the center of the central opening  48 .  
         [0051]     The valve plate  46  is mounted in the housing  36  for movement between first and second positions and in a direction that is transverse to a common center axis through the tubes  12  and  40 . In the first position, as illustrated in  FIG. 2 , the central opening  48  of the plate is not aligned with the tubes  12  and  40  and the valve plate  46  prevents fluid from flowing between the tubes  12  and  40 . In the second position, as illustrated in  FIG. 3 , the central opening  48  is aligned with the tubes  12  and  40  and the valve plate  46  permits fluid to flow between the tubes  12  and  40 .  
         [0052]     The valve plate  46  is in fluid sealed relation with the tubes  12  and  40  in either of the positions. As illustrated in  FIGS. 2 and 3 , an annular O-ring  50  seals the interface between the valve plate  46  and about the end  44  of the supply tube  40 , and an O-ring  52  seals the interface between the valve plate  46  and about the proximal end  16  of the tube  12 . So connected, the end faces of the tubes  12  and  40  are juxtaposed in sealed relation against the opposite planar faces of the valve plate  46 .  
         [0053]     According to this invention, the squeeze bulb  34  includes a central reservoir  54  and an attachment stub  56 . The reservoir  54  is dimensioned to receive a suitable volume of fluid, and the stub  56  defines a fluid outlet, which is connected to the tube  40 , thereby placing the fluid in the reservoir  54  in fluid communication with the inflation lumen  30  to suitably inflate the balloon. Depending on the application, the reservoir  54  may be filled with a suitable fluid medium, including a liquid, such as water or a saline solution, or air.  
         [0054]     Preferably, the elements of the valve  32  and the squeeze bulb  34  are of a material impermeable to liquid. Additionally, the material of the squeeze bulb is resilient, and able to be collapsed by the action of a hand gripping manipulation, and yet firm to maintain shape as well as return to its original state. In one application, the squeeze bulb  34  is comprised of an elastomeric material, such as rubber, so as to yield easily to dispense balloon-inflating liquid and also to snap back and be restored to its original shape. Depending on the application, the squeeze bulb  34  is comprised of a high-density polyethylene.  
         [0055]     The squeeze bulb  34  may be removably or non-removably secured to the end  42  of the supply tube  40 . In either case, the attachment stub  56  is fitted to the inlet end portion of the supply tube  40 .  
         [0056]     In an aspect of this invention, the reservoir  54  is provided with a pre-measured amount of fluid and the squeeze bulb  34  is permanently affixed to the supply tube  40 .  
         [0057]     In another aspect of this invention, fluid is added to the reservoir  54  and the squeeze bulb  34  is then fitted to the supply tube.  
         [0058]     In yet another aspect, the squeeze bulb  34  is dimensioned to receive a sufficient volume of air.  
         [0059]     In a method of use, the catheter  10  is prepared, with the valve plate  46  placed in the closed position ( FIG. 2 ), the reservoir  54  is filled as needed, and the squeeze bulb  34  is attached to the valve  32 . The distal end  14  of the catheter shaft  12  is inserted into the urethra of a patient until the tip  14  at the distal end of the shaft  12  is disposed within the bladder. The valve plate  46  is pushed in a simple hand movement into the open position ( FIG. 3 ), moving the opening  48  thereof into register with the tubes  12  and  40 . The squeeze bulb  34  is then squeezed by the hand, causing the saline solution (or air) to be expelled from the reservoir  54 , into and through the inflation lumen  30 , and through the inflation port  20 .  
         [0060]     The fluid thus transmitted by hand squeezing of the squeeze bulb  34  causes the balloon material engirding the inflation port  20  to expand outwardly and form into a balloon shape  58 , which shape engages the bladder wall of the patient to inhibit removal of the distal end of the catheter shaft  12  from the bladder.  
         [0061]     The valve plate  48  is then moved into the first position ( FIG. 2 ) to maintain the balloon  58  inflated.  
         [0062]     Should removal of the catheter be desired, the valve plate  46  is moved into the fluid permitting position ( FIG. 3 ), whereupon fluid flows outwardly of the balloon shape  58  and through the inflation lumen  30 , causing the balloon to deflate and the balloon material to snap back into engagement with the tube  12 .  
         [0063]     While not shown as being understood by those skilled in the art, the drainage funnel  22  is appropriately connected to a urine collection bag.  
         [0064]     As noted, the catheter according to this invention may be used in other therapeutic protocols.  
         [0065]     The squeeze bulb is a “suction apparatus” and is adapted to remove inflating fluid from within the balloon  58  by suction, such as by creating a partial vacuum, and drawing the inflating fluid back into the reservoir to be used again.  
         [0066]     The squeeze bulb or suction apparatus may be in the form of an aspirator, such as the aspirator  134  shown in  FIG. 4 , or the aspirator  234  shown in  FIGS. 5 and 6 . Each aspirator  134  and  234  is operated by hand, defines a fluid reservoir and fluid discharge port, and is configured for use with the control valve  32 . The aspirator  134  and  234  may also be referred to as a bulb or pump and each is adapted to remove inflating fluid from within the balloon  58  by suction, such as by creating a partial vacuum, and drawing the inflating fluid back into the aspirator to be used again.  
         [0067]     Turning to  FIG. 4 , the aspirator  134  is in the form of a one piece generally cylindrical bellows  60  of the pleated or accordion type, closed at the rearward end  62 , open at the forward end  64 , and forming a collapsible receptacle or reservoir  66  for storing a fluid for inflating the balloon  58 . The forward end  64  forms a round neck that is adapted to mount onto the cylindrical neck  42  protruding from the control valve  32  and form a fluid sealed fitment therewith. The bellows  60  is formed of a succession of annular generally V-shaped folds or pleats  68  that enable the body thereof to axially compress and/or expand. An axial force placed on the bellows  60  forces the ends  62  and  64  towards and away from one another, depending on the direction of force applied.  
         [0068]     The bellows  60  is preferably formed of a resilient material that remains flexible and enables the cylinder to move between an expanded state, when the reservoir is filled, and into a collapsed state, when expelling fluid through the port  42  and into the inflation lumen  30  to inflate the balloon  58 . Preferably, the material is resilient and adapted to restore the bellows  60  to its original shape. While many materials are contemplated, a suitable material comprises rubber, an elastomer, and a high-density polyethylene.  
         [0069]     Turning to  FIGS. 5 and 6 , the aspirator  234  is in the form of a one-piece cylindrical bellows  70  of the pleated or accordion type, closed at a rearward end  72 , open at the forward end  74 , and forming a collapsible receptacle or reservoir  76  for storing a fluid for inflating the balloon  58 . The forward end  74  is adapted to fit to the cylindrical neck  42  of the supply tube  40  protruding from the control valve  32  and form a sealed closure thereabout.  
         [0070]     The bellows  70  is formed of a succession of annular generally V-shaped folds or pleats  78  that enables the body of the aspirator  234  to axially compress. When an axial compressing force is placed on the ends  72  and  74  of the bellows  70 , that forces the ends to move towards one another, the bellows is compressed (see  FIG. 6 ).  
         [0071]     According to this embodiment, the rearward and rearward ends  72  and  74  form generally flat circular end walls. An annular cup-like element  80  projects inwardly from the rearward end wall  72  and into the reservoir or chamber  76 . The cup-like element  80  terminates in a mating end face  82  and forms an annular recess  84  between the pleats  78  and about the outer periphery of the cup-like element  80 . A cylindrical sleeve  86  projects inwardly from the forward end wall  74  and into the chamber  76 . The sleeve  86  terminates in an end face  88  and forms an annular recess  90  between the pleats  78  and about the outer periphery of the sleeve  86 . The sleeve  86  is adapted to fit in fluid sealed relation about the neck  42 .  
         [0072]     Importantly, when the sleeve  86  is mounted to the neck  42 , the inward end faces  43  and  88  of the neck  42  and the sleeve  86  combine to form a generally flat planar mating face  92  adapted to mate with the mating end face  82  of the cup-like element  80 . The mating between the end faces  82  and  92  is much like the mating engagement of a suction cup with a flat surface. When the bellows  70  is compressed, the mating end face  82  of the cup-like element  80  is forced towards and against the mating end face  92  formed by the sleeve  86  and neck  42 , pushing the air therebetween radially outwardly towards the annular recess  90 , eliminating the pressure inside the cup  80  and creating a vacuum, which seals, retains, and holds the cup element  80  tightly against the mating face  92 .  
         [0073]     The materials of the aspirator  234  are the same as those of the aspirator  134 .  
         [0074]     Further, and important to this aspect of the invention, a coil spring  94  is disposed within the fluid receiving chamber  76 . As shown, the coil spring  94  has opposite ends  96  and  98 , respectively, seated against the forward and rearward end walls  72  and  74 . The rearward and forward end portions of the coil spring  94 , respectively, nest within the forward and rearward annular recesses  84  and  90  formed about the cup-like element  80  and sleeve  82 .  
         [0075]     As illustrated in  FIG. 5 , in operation, the valve plate  46  is positioned upwardly, moving the central opening  48  from alignment with the fluid passages of the tubes  12  and  40 . The control valve  32  is in the closed position and prevents fluid flow therethrough and to or from the balloon. The chamber  76  is filled with fluid and the aspirator  234  is connected to the neck  42  of the control valve  32 .  
         [0076]     Referring to  FIG. 6 , substantially simultaneously, the valve plate  46  is manually pushed downwardly, causing the central opening  48  to be centered with the tubes  12  and  40  and the control valve to be in the open position, and the ends  72  and  74  moved towards one another. The bellows  70  and the coil spring  94  compress and fluid is discharged from the chamber  76 , through the inflation lumen  30 , and outwardly of the inflation port  20 , causing the membrane  24  to inflate and a balloon  58  to be formed within the bladder.  
         [0077]     Continued closing pressure is applied to the bellows  70 , bringing the mating end faces  82  and  92  into mated relation, causing air therebetween to be evacuated and generating a retention vacuum between the mating faces  82  and  92 . Substantially simultaneously, the valve plate  46  is closed, preventing fluid flow from the balloon and the retention vacuum creates a suction force that holds the bellows  70  in compressed relation.  
         [0078]     When removal of the catheter is desired, the valve plate  46  is moved to the open position, whereupon the coil spring  94  will expand the bellows  70 , fluids to be sucked, or withdrawn, from the balloon, and the balloon to deflate. The valve plate  46  is then moved into the closed position, preventing fluid to flow from the fluid chamber  76 . The catheter is then prepared for reuse, as desired.  
         [0079]     Although not shown in the drawing, it should be noted that either the squeeze bulb  34  or aspirator  134  and  234  may be provided with a sealed orifice to enable insertion of a syringe needle directly through the bulb and into the supply tube, thereby bypassing the bulb, depending on the exigencies of the situation.  
         [0080]     Having described preferred embodiments of my invention it is obvious that the invention described above is susceptible to many variations, modifications and changes without departing from the spirit of the invention or the scope of the appended claims. It should be understood that the invention is not to be limited except as by the appended claims.