Implant positioning system and method

Abstract

The use of implantable bulking materials for the treatment of urinary incontinence and a system for accurate positioning and delivery of bulking materials are described. The implantable materials are biocompatible, non-biodegradable implants which are designed for stabilization in soft tissue through the ingrowth of fibrous tissue after implantation. The positioning and delivery system comprises an injector which is adapted to allow a syringe to be attached and a housing. The housing includes a through cavity adapted to hold a viewing instrument, such as a cystoscope to allow accurate positioning of the injector. The housing also includes one or more injector through cavities, which are adapted to hold the injector at an angle to the viewing instrument. The angle between the viewing instrument and the injector is variably adjustable. The invention embraces the use of the bulking implants with various delivery methods, including the use of the described positioning and delivery system.

We claim:  
     
         1 . A method of treating urinary incontinence comprising the steps of: 
 making one or more incisions adjacent to the urethra for insertion of one or more implants into the periurethral wall; and    inserting one or more biocompatible, non-biodegradable implants for stabilization in soft tissue.    
     
     
         2 . The method of treating urinary incontinence described in  claim 1 , wherein the incisions adjacent to the urethra are made through the abdomen.  
     
     
         3 . The method of treating urinary incontinence described in  claim 1 , wherein the step of making one or more incisions adjacent to the urethra is performed cystoscopically.  
     
     
         4 . The method of treating urinary incontinence described in  claim 1 , wherein the one or more implants are composed of biocompatible, non-absorbable, non-biodegradable material which includes pores sized to allow fluid diffusion and to minimize tissue ingrowth.  
     
     
         5 . The method of treating urinary incontinence described in  claim 1 , wherein the one or more implants are composed of e-PTFE, polyurethane, polyethylene or a similar biocompatible, non-biodegradable material.  
     
     
         6 . The method of treating urinary incontinence described in  claim 1 , wherein the one or more implants comprise a tubular shaft with an internal cavity, the tubular shaft being composed of biocompatible, non-absorbable, non-biodegradable material which includes pores sized to allow fluid diffusion and to minimize tissue ingrowth.  
     
     
         7 . The method of treating urinary incontinence described in  claim 6 , wherein the tubular shaft is approximately 5 cm to 20 cm in length and approximately 1 mm to 20 mm in outside diameter.  
     
     
         8 . The method of treating urinary incontinence described in  claim 6 , wherein the tubular shaft is approximately 5 cm to 20 cm in length, approximately 1.5 mm to 4 mm in outside diameter, approximately 1 mm to 2 mm in wall thickness and approximately b  1  mm or more in inner diameter.  
     
     
         9 . The method of treating urinary incontinence described in  claim 6 , wherein segments have been created in the tubular shaft.  
     
     
         10 . The method of treating urinary incontinence described in  claim 9 , wherein the tubular shaft is approximately 5 cm to 20 cm in total length, approximately 1 mm to 20 mm in outside diameter and wherein each segment of the tubular shaft is approximately 2 mm. to 30 mm in length.  
     
     
         11 . The method of treating urinary incontinence described in  claim 9 , wherein the tubular shaft is approximately 5 cm to 20 cm in total length, approximately 1.5 mm to 4 mm in outside diameter, approximately 1 mm to 2 mm in wall thickness, approximately 1 mm or more in inner diameter and wherein each segment of the tubular shaft is approximately 2 mm to 30 mm in length.  
     
     
         12 . The method of treating urinary incontinence described in  claim 1 , wherein the one or more implants consist of a collection of tubular shafts.  
     
     
         13 . The method of treating urinary incontinence described in  claim 12 , wherein each tubular shaft is approximately 5 cm to 20 cm in total length and approximately 1 mm to 20 mm in outside diameter.  
     
     
         14 . The method of treating urinary incontinence described in  claim 12 , wherein each tubular shaft is approximately 5 cm to 20 cm in total length, approximately 1.5mm to 4 mm in outside diameter, approximately 1 mm to 2 mm in wall thickness, and approximately 1 mm or more in inner diameter.  
     
     
         15 . The method of treating urinary continence described in  claim 1 , wherein the one or more implants comprise a hollow string of small spheres.  
     
     
         16 . The method of treating urinary incontinence described in  claim 1 , wherein the one or more implants comprise a hollow string of small conjoined cylinders.  
     
     
         17 . The method of treating urinary continence described in  claim 1 , wherein the one or more implants comprise a solid string of small spheres.  
     
     
         18 . The method of treating urinary continence described in  claim 1 , wherein the one or more implants comprise a solid string of small cylinders.  
     
     
         19 . The method of treating urinary continence described in  claim 1 , wherein the one or more implants comprise a plurality of small spheres.  
     
     
         20 . A method of treating urinary incontinence comprising the steps of: 
 making one or more incisions which are essentially parallel to the urethra and injecting one or more implants into the periurethral tissue;    the one or more implants being biocompatible, non-biodegradable and designed for stabilization in soft tissue.    
     
     
         21 . The method of treating urinary incontinence described in  claim 20 , wherein the step of making one or more incisions in the urethral wall is performed cystoscopically.  
     
     
         22 . The method of treating urinary incontinence described in  claim 20 , wherein the one or more implants are composed of biocompatible, non-absorbable, non-biodegradable material which includes pores sized to allow fluid diffusion and to minimize tissue ingrowth.  
     
     
         23 . The method of treating urinary incontinence described in  claim 20 , wherein the one or more implants are composed of e-PTFE, polyurethane, polyethylene or a similar biocompatible, non-biodegradable material.  
     
     
         24 . The method of treating urinary incontinence described in  claim 20 , wherein the one or more implants comprise a tubular shaft with an internal cavity, the tubular shaft being composed of biocompatible, non-absorbable, non-biodegradable material which includes pores sized to allow fluid diffusion and to minimize tissue ingrowth.  
     
     
         25 . A method of treating urinary incontinence comprising: 
 a) having a system for accurate positioning and delivery of materials in vivo, the system comprising, 
 (i) an injector having an expulsion end and an opposite end, the opposite end having a 5 syringe attached thereto, the injector containing a bulking implant for treating urinary incontinence;  
 (ii) a viewing instrument having a distal end and a proximal end which remains outside the body; and,  
 (iii) a housing, the housing including a through cavity adapted to hold the viewing instrument, the housing further including a plurality of injector through cavities, each injector through cavity being adapted to hold the injector at an angle to the viewing instrument, each injector through cavity resulting in a different angle between the injector and the viewing instrument;  
   the expulsion end of the injector being positioned proximate to the distal end of  15  cystoscope;    b) selecting an injector through cavity through which to insert the injector and inserting the injector therethrough;    c) inserting the distal end of the viewing instrument into a urethra;    d) making an incision in the periurethral tissue using the expulsion end of the injector;    e) accurately positioning the expulsion end of the injector using the viewing instrument;    f) applying pressure to the syringe such that the bulking implant is delivered into the incision in the periurethral tissue;    g) removing the expulsion end of the injector and the distal end of the viewing instrument from the urethra.    
     
     
         26 . The method of treating urinary incontinence described in  claim 25 , further comprising the steps of 
 (i) inserting a balloon catheter into the incision in the periurethral tissue ii) filling the balloon catheter with a fluid or a gas;    (ii) removing the fluid or gas from the balloon catheter; and,    (iii) removing the balloon catheter from the incision; prior to the step of inserting the bulking material into the incision in the periurethral tissue.    
     
     
         27 . A method of treating urinary incontinence comprising the steps of: 
 a) creating a pocket in the periurethral tissue by a process comprising the steps of: 
 (i) making an incision in the periurethral tissue;  
 (ii) inserting a balloon catheter into the incision;  
 (iii) filling the balloon catheter with a fluid or a gas;  10  (iv) removing the fluid or gas from the balloon catheter; and,  
 (iv) removing the balloon catheter from the incision;  
   b) inserting bulking material into the pocket.