Coil catheter, method of use, and method of manufacture

Abstract

A catheter device and manufacturing process for manufacturing the catheter device, wherein the catheter device has a halo-shaped coiled portion extending away from a perpendicular stem portion through a swan neck portion. Eyelets on the halo coil portion and swan neck portion facilitate flow out of the bladder through the catheter device vertical to the catheter, rather than perpendicularly as is the case with existing catheters. The catheter device is formed by using a straight catheter tube, heating and cooling it within a formed mold to have the halo coil and swan neck, such that it can be straightened using a pusher and stylet, inserted into the body while straightened, and thereafter return to its coiled shape when the stylet is removed.

Having thus described the invention, what is claimed as new and desired to be secured by Letters Patent: 
     
         1 . A catheter system for a halo-style catheter capable of transforming a catheter from a first, straight orientation to a second, coiled orientation, the catheter system comprising:
 the catheter having a catheter body including a proximal end and a distal end;   said proximal end of said catheter body comprising a single coil terminating into a swan neck element and a right-angle bend, wherein said swan neck element and said right-angle element are configured to form a stabilizing elbow, and wherein said proximal end terminates into a tapered tip;   said stabilizing elbow configured to allow for dynamic movement and further configured to provide a memory force to allow for snap back in proximity with a sphincter;   said stabilizing elbow terminating into a straight stem culminating in said distal end of said catheter body, said straight stem configured to stent a prostatic urethra and to be placed above said sphincter without penetrating said sphincter during use;   said single coil being perpendicular to said straight portion;   a single first eyelet located along a horizontal plane of said single coil;   a single second eyelet located along said stabilizing elbow; and   whereas the catheter body functions as a prosthetic urethral stent while inserted in said body with said distal end located above said sphincter.   
     
     
         2 . The system of  claim 1 , further comprising:
 a suture-to-tube portion configured to allow for bridging said sphincter, positioning the catheter body, and removing the catheter body.   
     
     
         3 . The system of  claim 2 , wherein said suture-to-tube portion comprises an extra-luminal suture threaded through a pair of receivers passing through said catheter body about said distal end of said catheter body. 
     
     
         4 . The system of  claim 1 , further comprising:
 said catheter body comprising a suture-to-tube portion configured to place a suture external to a lumen of said catheter body and external to a pusher, thereby being configured to prevent obstruction and tethering of said catheter body and to allow for bridging said sphincter, positioning the catheter body, and removing the catheter body.   
     
     
         5 . The system of  claim 4 , further comprising:
 a snap cap configured to keep said suture from migrating and further configured to provide visual validation of placement of said catheter body; and   said snap cap comprising a magnet.   
     
     
         6 . The system of  claim 1 , further comprising:
 a pusher including a stylet having a guidewire, said pusher having a diameter smaller than a diameter of said catheter;   said guidewire configured to guide said catheter into place within said bladder while said stylet is inserted at least partially into said catheter; and   wherein said guidewire and said stylet are configured to be withdrawn from said catheter upon insertion into said bladder, thereby transforming said catheter from a first, straight orientation into a second, coiled orientation via said memory force.   
     
     
         7 . The system of  claim 6 , wherein a diameter of said pusher is less than a diameter of said catheter body. 
     
     
         8 . The system of  claim 1 , wherein said catheter body is comprised of Carbothane. 
     
     
         9 . The system of  claim 1 , further comprising:
 said catheter body configured to be manufactured from a first straight tube orientation using a mold base comprising a forming block having a swan neck form portion and a halo coil form portion;   said mold base configured to receive a mold cap secured to said mold base, said mold base and said mold cap configured to be heated by a heating element and subsequently configured to be chilled with a chiller; and   whereby said mold base, said heating element, and said chiller are configured to provide said memory force to said stabilizing elbow.   
     
     
         10 . A catheter system for a halo-style catheter capable of transforming a catheter from a first, straight orientation to a second, coiled orientation, the catheter system comprising:
 the catheter having a catheter body including a proximal end and a distal end;   said proximal end of said catheter body comprising a single coil terminating into a swan neck element and a right-angle bend, wherein said swan neck element and said right-angle element are configured to form a stabilizing elbow, and wherein said proximal end terminates into a tapered tip;   said stabilizing elbow configured to allow for dynamic movement and further configured to provide a memory force to allow for snap back in proximity with a sphincter;   said stabilizing elbow terminating into a straight stem culminating in said distal end of said catheter body, said straight stem configured to stent a prostatic urethra and to be placed above said sphincter without penetrating said sphincter during use;   said single coil being perpendicular to said straight portion;   a single first eyelet located along a horizontal plane of said single coil;   a single second eyelet located along said stabilizing elbow;   a suture-to-tube portion configured to allow for bridging said sphincter, positioning the catheter body, and removing the catheter body, wherein said suture-to-tube portion comprises an extra-luminal suture threaded through a pair of receivers passing through said catheter body about said distal end of said catheter body;   a pusher including a stylet having a guidewire, said pusher having a diameter smaller than a diameter of said catheter;   said guidewire configured to guide said catheter into place within said bladder while said stylet is inserted at least partially into said catheter;   wherein said guidewire and said stylet are configured to be withdrawn from said catheter upon insertion into said bladder, thereby transforming said catheter from a first, straight orientation into a second, coiled orientation via said memory force; and   whereas the catheter body functions as a prosthetic urethral stent while inserted in said body with said distal end located above said sphincter.