Endourethral device & method

Abstract

Embodiments of adjustable length intraurethral devices intended for patients with Lower Urinary Tract Symptoms (LUTS) are disclosed. These devices are to be placed within the human urethra and in communication with the bladder. Each device is easily adjustable to accommodate the prostatic length and sphincteric anatomy of the patient. Devices are stabilized in the urethra by two anchoring elements. The first anchor is fluid filled and positioned at the outlet of the bladder, and a second anchor is mechanical and is located at the bulbous urethra. These are separated by a structure which selectively supports a portion of the urethra from closing without restricting the portion of the urethra in the region of the external sphincter. These embodiments provide for the regulation of the flow of urine from the bladder by the natural control of the external sphincter when the user desires.

1 - 21 . (canceled)  
     
     
         22 . An endourethral stent adapted to deliver an effective amount of therapeutic agent to a lower urinary tract, the endourethral stent comprising a proximal anchor structure for cooperative engagement with a bladder neck so as to prevent device migration toward a bulbous urethra, a distal anchor structure for cooperative engagement with at least portions of the bulbous urethra so as to prevent device migration toward the bladder, a selectively dimensionable body for selectively fixing a dimension corresponding to a distance between said proximal and distal anchor structures, said body including a segment adapted to permit physiological external sphincter function.  
     
     
         23 . The endourethral stent of  claim 22  further comprising means for selectively fixing said selectively dimensionable body of said device.  
     
     
         24 . The endourethral stent of  claim 22  wherein said distal anchor structure is non-rigidly linked to a portion of said selectively dimensional body.  
     
     
         25 . The endourethral stent of  claim 22  wherein said distal anchor structure non-rigidly extends from a portion of said selectively dimensional body.  
     
     
         26 . The endourethral stent of  claim 22  further comprising a non-rigid linkage, said non-rigid linkage connecting said distal anchor structure to a portion of said selectively dimensional body.  
     
     
         27 . The endourethral stent of  claim 26  wherein said non-rigid linkage comprises a single suture.  
     
     
         28 . The endourethral stent of  claim 26  wherein said non-rigid linkage comprises a configuration of multiple sutures.  
     
     
         29 . The endourethral stent of  claim 26  wherein said non-rigid linkage includes a free end terminating at a retrieval tether of said stent.  
     
     
         30 . An endourethral device adapted to deliver an effective amount of therapeutic agent to a lower urinary tract, the endourethral device comprising a proximal anchor structure adapted to abuttingly engage at least portions of a bladder neck so as to at least proximally anchor said device, a selectively dimensionable body extending from said proximal anchor, and a distal anchor structure tethered to said body for engagement with a bulbous urethra.  
     
     
         31 . The endourethral device of  claim 30  wherein said body is longitudinally compactable.  
     
     
         32 . The endourethral device of  claim 31  wherein said body includes proximal and distal portions.  
     
     
         33 . The endourethral device of  claim 32  wherein said portions of said body are adapted for cooperative engagement.  
     
     
         34 . The endourethral device of  claim 32  wherein said portions of said body are selectively securable to each other.  
     
     
         35 . A catheter apparatus comprising an endourethral stent assembly and an insertion tool slidably receivable within a portion of said endourethral stent assembly, said endourethral stent assembly comprising a proximal anchor structure adapted to abuttingly engage at least portions of a bladder neck so as to at least proximally anchor said stent subsequent to delivery, a selectively dimensionable body extending from said proximal anchor, and a distal anchor structure tethered to said body for engagement with a bulbous urethra subsequent to delivery.  
     
     
         36 . The catheter apparatus of  claim 35  wherein said insertion tool includes a tubular element translatable within a sheath, said tubular element having a proximal extremity adapted to deliver fluid to a proximal end portion of said endourethral stent assembly.  
     
     
         37 . The catheter apparatus of  claim 36  wherein said proximal extremity of said tubular element includes sealing rings for cooperative engagement with a proximal end portion of said endourethral stent assembly.  
     
     
         38 . The catheter apparatus of  claim 36  wherein said proximal anchor structure of said endourethral stent assembly includes at least a single fluid fillable element.  
     
     
         39 . The catheter apparatus of  claim 38  wherein said sealing rings of said tubular element traverse a fluid filling port of said at least a single fluid fillable element.  
     
     
         40 . The catheter apparatus of  claim 36  wherein said selectively dimensionable body of said endourethral stent assembly is translatable upon said proximal extremity of said tubular element, and said distal anchor structure of said endourethral stent assembly is reversibly retained in a proximal extremity of said sheath.  
     
     
         41 . The catheter apparatus of  claim 40  wherein said proximal extremity of said sheath includes a push cup, at least a portion of said distal anchor structure of said endourethral stent assembly confined thereby.  
     
     
         42 . An catheter apparatus comprising an endourethral device, a retrieval system, and an insertion tool, said endourethral device comprising a stent body having a proximal fluid fillable anchor supported thereby, an expandable mechanical anchor non-rigidly linked to said stent body, said proximal fluid fillable anchor adapted to receive fluid via said insertion tool in furtherance of anchoring said device at a bladder neck, said retrieval system comprising a non-rigid tether having a first and second segments, said first segment terminating in a plug received by said fluid fillable anchor, said second segment passing through a portion of said device.