Apparatus and method to facilitate intermittent self-catheterization by a user

Abstract

A guidewire or other guide element has an elastically deformable distal end portion that is formed to have an unstrained shape or other features selected to allow the guide element to be safely retained inside a female's urinary bladder after placement therein via a tubular catheter by a doctor. The proximal end of the guide element extends out of her urethra to be easily accessible to her. When she needs to urinate, she passes the proximal end of the guide element into the distal end of another tubular catheter by herself and guides the catheter along the guide element into her bladder to pass out urine through the catheter. When her condition has improved, she or her doctor can withdraw the guide element via a similar catheter.

What is claimed is:  
     
         1 . A catheter guide element, comprising: 
 a flexible distal end portion having a predetermined shape when in an unstrained state, said shape being selected to ensure that the distal end portion tends to remain safely located within a fluid-containment body cavity of a user upon placement therein; and    a proximate end portion extendable from said body cavity, sized so that a proximate end thereof during use is readily accessible by the user to guide a user-held catheter along said proximal end portion into the body cavity.    
     
     
         2 . The guide element according to    claim 1   , wherein: 
 the proximate end portion is long enough to extend through and out of a proximate end of the catheter.    
     
     
         3 . The guide element according to    claim 1   , wherein: 
 a distal end of the guide element is free of sharpness, and a proximate end of the guide element is provided with a smoothly rounded bulbous form.    
     
     
         4 . The guide element according to    claim 1   , further comprising: 
 a smooth and kink-free external surface.    
     
     
         5 . The guide element according to    claim 1   , further comprising: 
 a coating having a smooth low-friction external surface.    
     
     
         6 . The guide element according to    claim 5   , wherein: 
 the coating comprises a polytetrafluoroethylene (“Teflon™”).    
     
     
         7 . The guide element according to    claim 1   , wherein: 
 the guide element comprises a super-elastic material.    
     
     
         8 . The guide element according to    claim 1   , wherein: 
 the guide element comprises a material that can in an unstrained state have different selected shapes at different temperatures.    
     
     
         9 . The guide element of    claim 8   , wherein the material comprises wire.  
     
     
         10 . The guide element according to    claim 1   , wherein: 
 the distal end portion comprises a generally conical helical shape when in an unstrained state at about or a little above normal human body temperature.    
     
     
         11 . The guide element according to    claim 1   , wherein: 
 the guide element has a diameter of about 2 French.    
     
     
         12 . The guide element according to    claim 3   , wherein: 
 the bulbous form at the proximate end of the guide element has a maximum diameter between three and four times the diameter of the guide element.    
     
     
         13 . The guide element according to    claim 3   , wherein: 
 the guide element is approximately 5 inches long.    
     
     
         14 . A guide element catheter system, comprising: 
 a tubular first catheter; and    a guide element having a flexibly deformable distal end portion which in an unstrained state has a predetermined shape and size selected to be safely retained within a fluid-containment cavity of a user's body during use, the guide element also having a proximal end portion with an end shaped and sized to enable easy access by the user to a proximal end thereof from outside the cavity, the entire guide element being sized and shaped to be readily slidable within the first catheter even when the distal end portion is in a strained state.    
     
     
         15 . The catheter system according to    claim 14   , wherein: 
 the first catheter has a distal end that is shaped and sized for easy insertion into the cavity, and has an internal first lumen that is shaped and sized to permit easy removal of the first catheter relative to the proximal end portion without removing the distal end portion from the cavity after placement therein.    
     
     
         16 . The catheter system according to    claim 14   , wherein: 
 the guide element is initially located entirely inside a lumen of the first catheter.    
     
     
         17 . The catheter system according to    claim 16   , wherein: 
 the proximate end of the guide element is provided with a smoothly rounded bulbous form having a maximum diameter smaller than a diameter of the lumen.    
     
     
         18 . The catheter system according to    claim 17   , further comprising: 
 an elongate element insertable into the lumen of the first catheter so as to press against said bulbous form of the guide element contained therein and to thereby move at least the distal end portion of the guide element out of the distal end of the lumen and into the cavity.    
     
     
         19 . The catheter system according to    claim 18   , wherein: 
 the elongate element is formed to enable a user to determine when the elongate element has been inserted into the lumen far enough to have moved at least the distal end portion of the guide element into the cavity.    
     
     
         20 . The catheter system according to    claim 16   , wherein: 
 the first catheter and the guide element are each at least about 8 inches long.    
     
     
         21 . The catheter system according to    claim 14   , further comprising: 
 at least a tubular second catheter, having an internal second lumen shaped and sized to permit easy passage thereof over and around the proximal end portion of said guide element following placement thereof in a patient's body to be guided thereby into the cavity under the user's control until fluid is enabled to flow out of the cavity via the second lumen.    
     
     
         22 . The catheter system according to    claim 21   , wherein: 
 the first catheter has an angled distal end with a smoothly rounded outer edge.    
     
     
         23 . The catheter system according to    claim 21   , wherein: 
 a lateral aperture with a rearwardly ramping rear edge portion is provided through a wall portion of the catheter near a distal end thereof, and further comprising a rearwardly ramping surface disposed under said lateral aperture to guide the proximal end of the guide element via the lateral aperture.    
     
     
         24 . The catheter system according to    claim 21   , wherein: 
 a lateral aperture with a rearwardly ramping rear edge portion is provided through a wall portion of the at least second catheter near a distal end thereof, and further comprising a rearwardly ramping surface disposed under said lateral aperture to guide the proximal end of the guide element via the lateral aperture.    
     
     
         25 . The catheter system of    claim 1   , wherein: 
 the guide element comprises a guidewire.    
     
     
         26 . A self-catheterization system, comprising: 
 an elongate guide element having a deformable elastic distal end portion which in an unstrained state has a predetermined shape and size selected to be safely retained within a fluid-containment cavity of a user's body during use following initial placement therein, the guide element having a proximal end position with a bulbous end sized and shaped to facilitate user access and handling thereof from outside the cavity;    an initial placement catheter having a length and an internal lumen shaped and sized to initially contain the entire guide element within;    an initial placement element slidable within the lumen of the initial placement catheter to move the guide element therein for placement of the distal end portion within the cavity for use thereafter by the user; and    a patient-use catheter having a distal end and a proximate end with an internal lumen extending therebetween, formed to have a lateral opening near the distal end and provided with an internal ramping surface disposed to direct the bulbous end of the guide element in movement thereof via the lateral opening while permitting flow from the distal end and the lateral opening to pass via the lumen to a proximate end of the patient-use catheter.    
     
     
         27 . A method of safe and convenient urinary bladder self-catheterization by a female, comprising the steps of: 
 placing in her bladder of a flexible preshaped distal end portion of a guide element in such a manner that a proximal end portion of the guide element is non-leakingly held in an opening of the bladder and a proximate end of the guide element is readily accessible by her; and    guiding a distal end of a tubular catheter element, by herself, around and along the guide element into her bladder to void urine through the catheter element.    
     
     
         28 . The method according to    claim 27   , wherein: 
 the step of placing the guide element includes the steps of a qualified person inserting the distal end of a placement catheter into her bladder via her urethra and then passing through the placement catheter the distal end of the guide element for safe retention thereof in an unstrained state within the bladder.    
     
     
         29 . A method of safe and convenient self-catheterization by a female, comprising the step of: 
 placing an elastically deformable distal end portion of a guide element of a predetermined unstrained shape within her urinary bladder, with a proximal end portion of the guide element extended via her urinary sphincter and urethra so that a proximate end of the guide element is easily accessible to her to enable her to guide a catheter along the guide element into her bladder to be able to void urine as needed.    
     
     
         30 . The method according to    claim 29   , comprising the further steps of: 
 guiding a catheter along the guide element into her bladder and then withdrawing the guide element through the catheter from her body; and    withdrawing the catheter from her body.