Minimally invasive bone manipulation device and method of use

Abstract

A novel surgical apparatus for use in orthopedic surgery procedures and a method for use is provided. The present invention includes a protective sheath which prevents fouling of the moving parts of the device by unwanted contact with surround tissue and bone. The device relates primarily to the treatment of traumatic, pathogenic, or osteoporotic bone conditions of human and other animal body systems and, more particularly, to a novel apparatus and method for manipulating the vertebral body through a less invasive, percutaneous, surgical approach.

1 . A surgical apparatus for use in manipulating tissue of a subject, comprising: 
 an elongated shaft assembly having a proximal end and a distal end, said elongated shaft comprising an actuating arm and an outer sleeve, said outer sleeve slidably circumscribing at least a portion of said actuating arm,    a handle assembly attached to said proximal end of said shaft assembly, said handle member being attached to said shaft assembly and configured such that actuation of said handle assembly is capable of effecting movement of actuating arm within said outer sleeve, and    a spreading assembly attached to said distal end of said shaft assembly, said spreading assembly comprising at least one bracing member and at least one extending arm and being at least partially surrounded by a protective sheath, said bracing member having a first end and a second end, said first end being rotationally attached to said actuating arm and said second end being rotationally attached to said extending arm, such that upon movement of said actuating arm, said bracing member is capable of radially displacing at least a portion of said extending arm,    wherein said radially displaced extending arm when displaced is capable of contacting and manipulating said tissue.    
     
     
         2 . The surgical apparatus of  claim 1 , wherein said tissue is within the vertebral body of said subject.  
     
     
         3 . The surgical apparatus of  claim 1 , further comprising a base plate attached to said extending arm.  
     
     
         4 . The surgical apparatus of  claim 3 , wherein said extending arm has a proximally disposed arm first end and a distally disposed arm second end, said base plate being attached at said arm second end.  
     
     
         5 . The surgical apparatus of  claim 4 , wherein said base plate is rotationally attached to said extending arm.  
     
     
         6 . The surgical apparatus of  claim 1 , wherein said spreading assembly is releasably attached to said shaft assembly such that when said spreading assembly is selectively released from said shaft assembly, said sheath remains in place with said spreading assembly.  
     
     
         7 . The surgical apparatus of  claim 5 , wherein said spreading assembly can be locked in a position such that said base plate is radially displaced from said shaft assembly.  
     
     
         8 . The surgical apparatus of  claim 1 , wherein said bracing member is manufactured of rigid material.  
     
     
         9 . The surgical apparatus of  claim 1 , wherein said handle assembly comprises a first handle member and a second handle member.  
     
     
         10 . The surgical apparatus of  claim 9 , wherein said handle assembly further comprises a biasing member, said biasing member being configured to keep said first handle member apart from said second handle member.  
     
     
         11 . The surgical apparatus of  claim 9 , wherein said handle assembly further comprises a controlled compression assembly, which is capable of fine-tuned control of the compression of the two handle members.  
     
     
         12 . The surgical apparatus of  claim 9 , wherein said first handle member comprises a actuating arm anchor, said actuating arm being movably connected to said arm anchor.  
     
     
         13 . The surgical apparatus of  claim 12 , wherein said second handle member comprises an actuating arm portal, said arm portal being connected to said outer sleeve; such that when said first handle member and said second handle member are moved in relation one to the other, said actuating arm slidably moved within said outer sleeve through said actuating arm portal.  
     
     
         14 . The surgical apparatus of  claim 1 , wherein said spreading assembly comprises multiple extending arms and multiple bracing members.  
     
     
         15 . The surgical apparatus of  claim 14 , wherein said extending arms are rotationally connected to a base plate.  
     
     
         16 . The surgical apparatus of  claim 15 , wherein said base plate has two extending arms rotationally connected thereto at a single rotation point.  
     
     
         17 . The surgical apparatus of  claim 15 , wherein said base plate has two extending arms rotationally connected at separate respective rotation points.  
     
     
         18 . The surgical apparatus of  claim 14 , wherein said extending arms and said bracing members are aligned one to another in a scissor-jack configuration.  
     
     
         19 . The apparatus of  claim 1 , wherein at least two of the following are releasably connected one to the other, said shaft assembly, said handle assembly and said spreading assembly.  
     
     
         20 . The apparatus of  claim 1 , wherein said handle assembly is a knob-type assembly.  
     
     
         21 . The apparatus of  claim 1 , wherein said handle assembly further comprises a handle position lock.  
     
     
         22 . The apparatus of  claim 1 , wherein at least a portion of said device is radiopaque.  
     
     
         23 . The apparatus of  claim 1 , wherein said sleeve is so configured as to be capable of acting as a conduit for bone cement being injected into a space formed by said spreading assembly after removal of said actuating arm from said sleeve.  
     
     
         24 . A method of forming a space within a vertebral body of a subject, the method comprising: 
 providing an apparatus according to  claim 1 ,    inserting said apparatus into the vertebral body of said subject,    actuating the handle assembly so as to cause the spreading assembly to open and contact the interior bone material of the vertebral body,    whereby said vertebral body has a space formed.    
     
     
         25 . The method of  claim 24 , wherein said inserting step is accomplished using minimally invasive surgical technique.  
     
     
         26 . The method of  claim 24 , where said spreader assembly of said apparatus according to  claim 1  is disconnected and left within said vertebral body after said space is formed.  
     
     
         27 . The method of  claim 24 , wherein said spreading assembly is removed from said vertebral body after said space is formed.  
     
     
         28 . The method of  claim 26 , further comprising the step of filling said space formed with supporting material.  
     
     
         29 . The method of  claim 27 , further comprising the step of filling said space formed with supporting material.