Catheterization Assembly

Abstract

A disposable hydrophilic catheterization device for inserting a hydrophilic catheter into the urethra of an individual for the purpose of evacuating the bladder is disclosed. The catheter device includes a catheter introducer, a flexible hydrophilic catheter and a flexible thin-walled sheath. The sheath surrounds the urethra-insertable portion of the catheter, is adapted for containing a wetting liquid, and prevents pooling of the wetting liquid with collected urine. A leak-resistant diaphragm disposed within the catheter introducer is capable of being pierced by the catheter tip to form a leak-resistant orifice around the wetted hydrophilic catheter as it moves through the orifice.

1 . A urinary catheterization device for self-catheterization, the device comprising:
 an introducer including a cavity adapted to contain an amount of a wetting liquid and an aperture adapted to contact a urethral opening;   a catheter made of a hydrophilic material including a urine inlet, a urine outlet, and a urethra-insertable portion;   a sheath sealingly attached to the catheter and the introducer such that the sheath substantially surrounds the urethra-insertable portion of the catheter; and   a diaphragm disposed in the introducer, the diaphragm adapted to be pierced by the urine inlet, the diaphragm adapted to prevent the wetting liquid from flowing out of the introducer prior to the diaphragm being pierced;   wherein the diaphragm is adapted to allow the wetting liquid to enter the sheath to render the urethra-insertable portion of the catheter lubricious after the urine inlet pierces the diaphragm and is then retracted into the sheath.   
     
     
         2 . The device of  claim 1 , wherein the introducer includes a first guide section and a section guide section, the second guide section containing the wetting liquid, the diaphragm disposed between the first guide section and the second guide section. 
     
     
         3 . The device of  claim 2 , wherein the urine inlet is initially disposed in the first guide section. 
     
     
         4 . The device of  claim 1 , wherein the hydrophilic material is polybinylchloride coated with polyvinylpyrrolidone. 
     
     
         5 . The device of  claim 1 , wherein the wetting liquid is one of water and saline. 
     
     
         6 . The device of  claim 1 , wherein once the wetting liquid enters the sheath, the urethra-insertable portion of the catheter is rendered lubricious within thirty seconds. 
     
     
         7 . The device of  claim 1 , wherein the wetting liquid enters the sheath when the introducer is squeezed. 
     
     
         8 . The device of  claim 1 , wherein the wetting liquid enters the sheath while oriented such that the introducer is above the sheath. 
     
     
         9 . The device of  claim 1 , further comprising a urine collection container sealingly attached to the urine outlet. 
     
     
         10 . A urinary catheterization device for self-catheterization, the device comprising:
 a container adapted to contain an amount of a wetting liquid, the container including a urethral contact opening;   a catheter made of a hydrophilic material including a urine inlet, a urine outlet, and a urethra-insertable portion;   an enclosure sealingly attached to the catheter and the container such that the enclosure substantially surrounds the urethra-insertable portion of the catheter; and   a scored portion on the container capable of preventing the wetting liquid from flowing out of the container and into the enclosure prior to the scored portion being pierced, the scored portion adapted to be pierced by the urine inlet;   wherein the scored portion is adapted to allow the wetting liquid to enter the enclosure to render the urethra-insertable portion of the catheter lubricious after the urine inlet pierces the scored portion and is then retracted into the enclosure.   
     
     
         11 . The device of  claim 10 , wherein the container includes a first guide section and a section guide section, the second guide section containing the wetting liquid, the scored portion disposed between the first guide section and the second guide section. 
     
     
         12 . The device of  claim 11 , wherein the urine inlet is initially disposed in the first guide section. 
     
     
         13 . The device of  claim 10 , wherein the hydrophilic material is polybinylchloride coated with polyvinylpyrrolidone. 
     
     
         14 . The device of  claim 10 , wherein the wetting liquid is one of water and saline. 
     
     
         15 . The device of  claim 10 , wherein once the wetting liquid enters the enclosure, the urethra-insertable portion of the catheter is rendered lubricious within thirty seconds. 
     
     
         16 . The device of  claim 10 , wherein the wetting liquid enters the enclosure while oriented such that the container is above the enclosure. 
     
     
         17 . A method for preparing a urinary catheter assembly for self-catheterization, the method comprising:
 piercing a diaphragm with a catheter, the diaphragm disposed in an introducer of the urinary catheter assembly, the introducer including a cavity adapted to contain an amount of a wetting liquid and an aperture adapted to contact a urethral opening, the diaphragm adapted to prevent the wetting liquid from flowing out of the introducer prior to the diaphragm being pierced, the catheter made of a hydrophilic material including a urine inlet, a urine outlet, and a urethra-insertable portion, the diaphragm adapted to be pierced by the urine inlet, the urinary catheter assembly further including a sheath sealingly attached to the catheter and the introducer such that the sheath substantially surrounds the urethra-insertable portion of the catheter;   retracting the catheter into the sheath allowing the wetting liquid to enter the sheath lumen to render the urethra-insertable portion of the catheter lubricious.   
     
     
         18 . The method of  claim 17 , further comprising orienting the urinary catheter assembly such that the introducer is above the sheath. 
     
     
         19 . The method of  claim 17 , further comprising squeezing the introducer. 
     
     
         20 . The method of  claim 17 , further comprising removing a removable aperture cover from the aperture.