Spinal grooved director with built in balloon and method of using same

Abstract

The present invention is directed toward a grooved director with a built in balloon which is inflated by a pump to a predetermined pressure to expand the walls of a collapsed vertebra. The device is inserted into the body of the compressed vertebra and the grooved director is positioned and aimed in a direction under the compressed superior end plate of the vertebral body. The balloon inside of the grooved director is inflated and the force and direction of balloon inflation restores the height of the fractured vertebrae. The balloon is deflated and the grooved director is circumferentially rotated while intermittently inflating and deflating the balloon to creates a symmetrical space within the center of the vertebral body. The balloon is deflated and the grooved director device with balloon is removed leaving a rebuilt vertebra which may be filled with a biocompatible material.

What I claim is:  
     
         1 . A grooved director apparatus to aid in the insertion of a balloon catheter into a vertebra comprising an elongated substantially rigid tubular member defining a longitudinal axis with a closed distal tip and an open proximal end portion, an inflatable balloon mounted in said tubular member, said tubular member being cut away from a point along the longitudinal axis to said closed distal tip forming a balloon seat allowing directed expansion of said balloon away from said longitudinal axis toward an area to which compression is to be applied allowing guidance and control of the force of expansion in the vertebra, anchor means mounted to said tubular member keeping said tubular member in a fixed position when said balloon is inflated while allowing selective circumferential rotation of said tubular member when said balloon is deflated and pump means fluidly connected to said rigid tubular member to apply selected fluid pressure to said balloon.  
     
     
         2 . A grooved director apparatus as claimed in  claim 1  wherein said tubular member is stainless steel.  
     
     
         3 . A grooved director apparatus as claimed in  claim 1  wherein said pump means comprises a syringe body, a plunger mounted in said syringe body, a pressure gauge mounted at the distal end of said syringe body and a connector conduit leading from a tip at the end of said syringe body to allow fluid communication with said balloon.  
     
     
         4 . A grooved director apparatus as claimed in  claim 1  wherein said anchor means comprises a housing defining a through going bore for receiving said rigid tubular member, a second bore intersecting said through going bore and a locking member mounted in said second bore adapted to engage said rigid tubular member and hold the same in a locked position.  
     
     
         5 . A grooved director apparatus as claimed in  claim 3  wherein said syringe body has a cylindrical housing and said plunger has a cylindrical body, said syringe body being provided with locking means to lock said plunger in a fixed position within said body.  
     
     
         6 . A grooved director apparatus as claimed in  claim 3  wherein said syringe body has a cylindrical housing with internal threading, and said plunger has a cylindrical body with external threading.  
     
     
         7 . A grooved director apparatus as claimed in  claim 1  wherein said syringe housing includes a handle mechanism comprising at least two wing members extending outward from the syringe housing to provide easy grasping of the syringe housing.  
     
     
         8 . A grooved director apparatus as claimed in  claim 1  wherein said pump means includes a flexible tubing connected to the distal end of a syringe to transport flowable material from said syringe and a locking tip secured to the distal end of said flexible tubing, said locking tip being a adapted to be locked in a fixed position relative to said rigid groove director.  
     
     
         9 . A grooved director apparatus as claimed in  claim 8  wherein said locking tip comprises a bayonet type tip.  
     
     
         10  A grooved director apparatus as claimed in  claim 8  wherein said locking tip comprises a tip member with external threads.  
     
     
         11 . A grooved director apparatus to aid in the insertion of a balloon catheter into a vertebra comprising an elongated substantially rigid tubular member defining a longitudinal axis with a closed distal tip and an open proximal end portion, an inflatable balloon moveably mounted in said tubular member, said tubular member being cut away from a point along the longitudinal axis to said closed distal tip forming a balloon seat allowing directed expansion of said balloon away from said longitudinal axis toward an area to which compression is to be applied allowing guidance and control of the force of expansion in the vertebra, anchor means mounted to said tubular member keeping said tubular member in a fixed position when said balloon is inflated while allowing selective circumferential rotation of said tubular member when said balloon is deflated and pump means fluidly connected to said rigid tubular member to apply selected fluid pressure to said balloon, said pump means comprising a syringe body, a plunger mounted in said syringe body, a pressure gauge mounted at the distal end of said syringe body and a connector conduit leading from a tip at the end of said syringe body to provide fluid communication with said balloon.  
     
     
         12 . A grooved director apparatus as claimed in  claim 11  wherein said balloon includes a guide wire  
     
     
         13 . A grooved director apparatus as claimed in  claim 11  wherein said connector conduit comprises a flexible tubing mounted to said tip of said syringe to transport flowable material from said syringe and a locking tip mounted to a distal end of said flexible tubing, said locking tip being a adapted to be locked in a fixed position relative to said rigid groove director.  
     
     
         14 . A grooved director apparatus as claimed in  claim 11  including a connector member mounted to a distal end of said grooved director and adapted to hold a locking tip of said connector conduit.  
     
     
         15 . A grooved director apparatus as claimed in  claim 11  wherein said anchor means comprises a housing defining a through going bore for receiving said rigid tubular member, a second bore intersecting said through going bore and a locking member mounted in said second bore adapted to engage said rigid tubular member and hold the same in a locked position.  
     
     
         16 . A method of expanding a compressed vertebra to substantially its original natural configuration comprising the steps of: 
 a) inserting a grooved director with a built in balloon into the body of a compressed vertebra through a hole cut through said vertebra;    b) positioning said grooved director in a direction under a compressed superior end plate of said vertebra;    c) inflating said balloon carried by said grooved director away from the axis of the grooved director so that the force and direction of balloon inflation reduces and restores the height of the fractured compressed vertebra;    d) deflating said balloon and rotating said grooved director so that said balloon seat faces a direction different from the initial placement direction;    e) inflating said balloon to create a symmetrical space within the center of the vertebral body;    f) deflating said balloon and removing said grooved director device with built in balloon;    g) reinserting said grooved director into the space withing the center of the vertebral body;    h) inserting osteogenic material through the grooved director into a space within the center of the vertebral body; and    i) removing said grooved director from said vertebral body and sealing the osteogenic bone material within said vertebral body.    
     
     
         17 . A method as claimed in  claim 16  wherein said osteogenic material is demineralized bone.  
     
     
         18 . A method of expanding a compressed vertebra to approximately it's original natural shape comprising the steps of: 
 a) inserting a grooved director with the built-in balloon into the body of the compressed vertebrae through a trochar insertion sheath;    b) positioning a grooved director with a built in balloon in a direct ion under a compressed superior end plate of the vertebral body;    c) inflating said balloon so that the force and direction of balloon inflation reduces and restores the height of the fractured vertebra;    d) deflating said balloon and rotating said grooved director to a new position within said factured vertebra and inflating said balloon to create a symmetrical space within the center of the vertebral body; and    e) deflating said balloon and removing the grooved director device with balloon from the trochar insertion sheath.    
     
     
         19 . The method of  claim 18  including the additional steps of inserting a grooved director without balloon through the trochar insertion sheath into the space within the center of the vertebral body depositing a biocompatible material into the vertebrae body.  
     
     
         20 . The method of  claim 19  wherein said biocompatible material consists of a group selected from hydroxyapatite, various formulations of biocompatible calcium phosphates, biocompatible calcium sulfates, demineralized and/or mineralized bone particles, polymer based implants including polyglycolic acid and/or polylactic acid compounds, collagen and/or collagen derivative preparations alone or in combination with other biomaterials, chitin and/or chitosan preparations, bioglasses including oxides of silicon, sodium, calcium and phosphorous and combinations thereof.  
     
     
         21 . The method of  claim 18  wherein step d) is repeated a plurality of times  
     
     
         22 . The method of  claim 18  wherein said grooved director with built in balloon is inserted into the body of the compressed vertebrae through a pedicular approach  
     
     
         23 . The method of  claim 18  wherein said grooved director with built in balloon is inserted into the body of the compressed vertebra through an extrapedicular approach.  
     
     
         24 . A method of expanding a compressed vertebra comprising the steps of: 
 a) inserting a grooved director with the built-in balloon into the body of the compressed vertebrae through a trochar insertion sheath;    b) positioning a grooved director with a built in balloon in a direction under a compressed superior end plate of the vertebral body;    c) inflating said balloon so that the force and direction of balloon inflation reduces and restores the height of the fractured vertebra;    d) deflating said balloon and rotating said grooved director to a new position within said fractured vertebra and inflating said balloon to create a symmetrical space within the center of the vertebral body;    e) deflating said balloon and removing the grooved director device with balloon is removed from the trochar insertion sheath;    f) inserting a grooved director without balloon through the trochar insertion sheath into the space within the center of the vertebral body' and    g) depositing an osteogenic material into the vertebra body.    
     
     
         25 . The method of  claim 24  wherein said osteogenic material consists of a group selected from hydroxyapatite, various formulations of biocompatible calcium phosphates, biocompatible calcium sulfates, demineralized and/or mineralized bone particles, collagen and/or collagen derivative preparations alone or in combination with other biomaterials, chitin and/or chitosan preparations.