Patent Publication Number: US-2022226606-A1

Title: Obstetrical Urinary Catheter

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates to an improved urinary catheter having a unique low profile by which to retain the catheter within the bladder so that urine can be removed therefrom during the labor and delivery process without obstruction of the fetal vertex and resulting iatrogenic obstruction of labor and injury to maternal urethral and bladder tissue. 
     2. Prior Art 
     Known to those skilled in the art, a conventional Foley catheter is inserted into the female urethral opening and through its length into the urinary bladder of a female patient until the proximal end of the catheter contacts the upper wall of the patient&#39;s bladder. The Foley catheter balloon is then inflated, while in situ, and the catheter is retracted slowly until the inflated balloon encounters some resistance against the lower bladder wall. The inflated balloon retains the catheter within the bladder so that urine can be removed therefrom and delivered to a bladder bag for disposal. 
     However, there are several significant problems which may arise as a consequence of using a conventional Foley catheter during the labor process. More particularly, an inflated Foley balloon typically assumes a spherical configuration which consumes a relatively large volume within the patient&#39;s bladder. The large volume consumed by the Foley balloon and in its current spherical configuration correspondingly increases the occurrence of direct obstruction of the descending fetal head and the arrest of the labor process and resulting increase in the rate of cesarean section. With prolonged obstruction the occurrence of injury to maternal urethra and bladder may occur resulting in loss of the physiological angle of the urethra, incontinence, and other chronic urinary complaints which may require surgical correction. 
     SUMMARY OF THE INVENTION 
     Briefly, an improved urinary catheter is disclosed by which to overcome the shortcomings of the Foley catheter. The catheter includes a low volume, low profile means by which to retain the catheter within the bladder so that urine may be removed therefrom without obstruction of the descending fetal vertex during the labor process. More particularly, the retaining means of the improved catheter has less obstruction volume and presence in the bladder than that which would ordinarily be consumed and obstructed by a conventional spherically shaped Foley balloon. Accordingly, both the frequency and severity of fetal vertex obstruction and maternal tissue injury by the application of excessive obstructive volume, such as that generated when a Foley balloon is inflated within the bladder, can be reduced. Thus, by eliminating the obstruction within the bladder, the patient will be less likely to incur an obstructed or arrested labor from iatrogenic cause and the subsequent increase in operative delivery and future urologic complications. 
     According to the embodiment of the invention, the retaining means is an additional inflatable balloon placed proximal to the traditional balloon having a thin, flat, flexible, pancake-like (rather than a spherical) configuration. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a diagrammatic view of the obstetrical urinary bladder and urethral catheter in the deflated state. 
         FIG. 2  is a diagrammatic view of the obstetrical urinary bladder and urethral catheter with the labor balloon inflated and the standard balloon deflated. 
         FIG. 3  is a diagrammatic view of the obstetrical urinary bladder and urethral catheter with the standard balloon inflated and the labor balloon deflated. 
     
    
    
     Section A-A is a cross sectional view of the mid portion of the obstetrical urinary bladder and urethral catheter. 
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
     The improved urinary catheter is now described while referring concurrently to  FIGS. 1-3  of the drawings. In  FIG. 1-3 , the catheter is shown with the distal end, catheter tip  20  oriented at the top of the page. In  FIG. 3 , the obstetrical catheter includes a larger 10 cc conventional Foley-style retaining balloon  30  which is received within the patient&#39;s bladder  35 . Balloon  30  is inflated, while in situ, so as to be seated against the relatively narrow neck of a bladder  35 , whereby to prevent an inadvertent removal of the catheter therefrom. The balloon  30  is inflated with a 10 cc supply of fluid (e.g. water or isotonic or iso-osmotic fluid, or the like) via an inflation channel  150  (Section A-A) which extends longitudinally through catheter between the balloon  30  and a syringe docking port  130  having a check valve  110  associated therewith to prevent an inadvertent deflation of the balloon. As in a conventional catheter, the presently disclosed obstetrical catheter also includes a centrally disposed urine passage  140  (Section A-A) which extends longitudinally through the catheter from a urine inlet aperture  10  to the distal base  120  at which urine can be collected in a bladder bag (not shown) for disposal. 
     Unlike the conventional catheters, and as an important feature of the obstetrical catheter, a second inflatable balloon  50 ,  FIG. 2  is incorporated into the catheter structure. In  FIG. 2 , the obstetrical catheter includes a smaller 3 cc flat unique low-profile retaining balloon  50  which is received within the patient&#39;s bladder  35 . Balloon  50  is inflated, while in situ, so as to be seated against the relatively narrow neck of a bladder  35 , whereby to prevent an inadvertent removal of the catheter therefrom. The balloon  50  is inflated with a 3 cc supply of fluid (e.g. water or isotonic or iso-osmotic fluid, or the like) via an inflation channel  160  (Section A-A) which extends longitudinally through catheter between the balloon  50  and a syringe docking port  130  having a check valve  100  associated therewith to prevent an inadvertent deflation of the balloon. 
     Referring now to  FIG. 1  The obstetrical catheter has the deflated standard balloon sheath  80  and the deflated labor balloon sheath  90  on the distal end of the catheter just proximal to the urine inlet apertures.  FIG. 1  shows the labor insertion marker  70  proximal to the labor balloon sheath  90 . This labor insertion marker  70  is used to gauge the distance the obstetrical catheter should be inserted prior to inflating the labor balloon  50 . When a obstetrical patient has a indication for a indwelling catheter, most commonly in labor with epidural anesthesia in place, the obstetrical catheter is placed in configuration shown in  FIG. 1 . The catheter tip  20  is inserted into the female urethra and advanced to the insertion marker  70 . With the insertion marker  70  at the urethral opening, a syringe with sterile saline is attached to syringe docking port  130  attached to labor balloon check valve  100 . A volume of 3 cc of saline is then injected resulting in the inflation of the labor balloon  50 . The syringe is then removed from the syringe docking port  130 . This allows labor to progress and the fetal vertex to descend without the iatrogenic obstruction related to a large volume catheter while simultaneously keeping the indwelling catheter in place. Should the need arise for a cesarean section, the syringe is then attached to the syringe docking port  130  attached to the standard balloon check valve  110 . A volume of 10 cc of saline is then injected resulting in the inflation of the standard balloon  30 . The labor balloon  50  is then deflated by removing the 3 cc volume by attaching a empty syringe to the syringe docking port  130  attached to the labor balloon check valve  100  and withdrawing the saline. The labor balloon  50  should not be re-inflated, unless the insertion marker  70  is confirmed to be at the opening of the urethra to avoid inadvertent injury to the urethral structure. 
     The obstetrical catheter can be used for all other non-labor indications requiring an indwelling catheter because of the retention of the traditional standard balloon  30 . This feature allows versatility without requiring the need for additional materials, supplies, or multiple indwelling catheters. It will be apparent that while a preferred embodiment of the invention has been shown and described, various modifications and changes may be made without departing from the true spirit and scope of the invention.