Bulking agent needle apparatus and method of using the needle apparatus

Abstract

The present invention provides a syringe and a hypodermic needle having both linear and arcuate segments for injecting bulking agents into soft tissue planes between an organ and surrounding sphincter muscle to treat undesired sphincter-related deficiencies such as stress urinary incontinence, anal incontinence and esophageal reflux. A penetration depth shield or guide may be added to the hypodermic needle to limit the penetration of the needle and aid in the proper positioning of the needle. In one embodiment, a method for injecting a bulking agent into the soft tissue plane between the urethra and surrounding sphincter muscle and/or proximal urethral submucosa by using a hypodermic needle having both linear and arcuate segments, a penetration depth shield and a syringe containing a bulking agent is provided. The bulking agent may comprise a plurality of discrete carbon coated substrate particles that are carried in a fluid and lubricative biocompatible medium. In addition, a needle kit for treating stress urinary incontinence is provided.

What is claimed is:  
     
         1 . An apparatus for injecting a bulking agent into a tissue plane between an esophagus, rectum, or urethra and surrounding sphincter muscle comprising a syringe and a hypodermic needle, wherein said hypodermic needle is comprised of a linear segment extending from a hub of the syringe and an arcuate segment formed by about a 5-45 degree bend located within a position of the needle closest to a needle tip.  
     
     
         2 . The apparatus of  claim 1  wherein said hypodermic needle has an accurate segment formed by about a 15 degree bend.  
     
     
         3 . The apparatus of  claim 1  wherein said hypodermic needle has a length of about 1.5-60 inches.  
     
     
         4 . The apparatus of  claim 1  wherein said hypodermic needle has a length of about 1.5-5 inches.  
     
     
         5 . The apparatus of  claim 1  wherein said hypodermic needle is sufficiently rigid so as to maintain the arcuate segment while retaining a minimal amount of flexure to allow proper insertion of the needle into tissue.  
     
     
         6 . The apparatus of  claim 1  wherein a penetration depth shield is located on the linear segment of the hypodermic needle and limits tissue penetration of the needle.  
     
     
         7 . The apparatus of  claim 1  wherein said syringe contains an injectable solution comprising a bulking agent.  
     
     
         8 . A method of using a needle, penetration depth shield, and syringe to inject a bulking agent into a tissue plane between an esophagus, rectum or urethra and surrounding sphincter muscle to treat sphincter deficiencies comprising the steps of 
 preparing and priming a hypodermic needle comprised of a linear segment extending from a hub of the syringe and an arcuate segment formed by a 15 degree bend located within a portion of the needle closest to a tip of the needle, a penetration depth shield located on said linear segment, and a syringe containing a bulking agent;    advancing the needle slowly until it penetrates past an external sphincter muscle using the 15 degree angle of the needle to guide it in an arc to submucosal tissue between the esophagus, rectum or urethra and a muscle plane;    positioning the needle to confirm placement within the submucosal tissue; and    attaching the syringe to the needle and injecting a bulking agent into the submucosal tissue.    
     
     
         9 . The method of  claim 8 , wherein a cystoscope is inserted into the esophagus, rectum or urethra before penetrating the tissue with the needle to guide placement of the needle.  
     
     
         10 . The method of  claim 8 , wherein said bulking agent is comprised of a plurality of discrete carbon coated particles in a carrier.  
     
     
         11 . The method of  claim 8 , wherein said carbon coated particles are of rounded shape and said dimension is between 200 and 500 microns.  
     
     
         12 . A needle kit for treating stress urinary incontinence, comprising: 
 a syringe;    a hypodermic needle, wherein said hypodermic needle is comprised of a linear segment extending from a hub of the syringe and an arcuate segment formed by a 15 degree bend located within a portion of the needle closest to a tip of the needle;    a penetration depth shield; and    an injectable bulking agent.    
     
     
         13 . The kit of  claim 12 , wherein said bulking agent is comprised of a plurality of discrete carbon coated particles in a carrier.  
     
     
         14 . The kit of  claim 12 , wherein said carbon coated particles are of rounded shape and have an average transverse cross-sectional dimension of between 200 and 500 microns.