Inflatable device for use in surgical protocol relating to fixation of bone

Abstract

A balloon for use in compressing cancellous bone and marrow (also known as medullary bone or trabecular bone) against the inner cortex of bones whether the bones are fractured or not. The balloon comprises an inflatable, non-expandable balloon body for insertion into said bone. The body has a shape and size to compress at least a portion of the cancellous bone to form a cavity in the cancellous bone and to restore the original position of the outer cortical bone, if fractured or collapsed. The balloon is prevented from applying excessive pressure to the outer cortical bone. The wall or walls of the balloon are such that proper inflation the balloon body is achieved to provide for optimum compression of all the bone marrow. The balloon is able to be folded so that it can be inserted quickly into a bone. The balloon can be made to have a suction catheter. The main purpose of the balloon is the forming or enlarging of a cavity or passage in a bone, especially in, but not limited to, vertebral bodies.

In the claims:  
     
         1 . A balloon for use in treating a bone predisposed to fracture or to collapse, or that is fractured or collapsed, comprising: 
 an inflatable, non-expandable balloon body for insertion into said bone, said body having a predetermined shape and size, when substantially fully inflated, sufficient to compress at least a portion of the inner cancellous bone to create a cavity in said cancellous bone, said balloon body being restrained to create said predetermined shape and size so that the fully inflated balloon is prevented from applying excessive pressure to the inner surface of the outer cortical bone if said bone is unfractured or uncollapsed.    
     
     
         2 . A balloon as set forth in    claim 1   , wherein said balloon body has restraining means to limit the size of said body.  
     
     
         3 . A balloon as set forth in    claim 1   , wherein said balloon body has restraining means to limit the shape of said body.  
     
     
         4 . A balloon as set forth in    claim 1   , wherein said body has a number of corners, said corners defining a restraint to restrain said balloon body.  
     
     
         5 . A balloon as set forth in    claim 1   , wherein said body includes a pair of stacked body parts having means for coupling the body parts together, the coupling means of said body parts defining a restraint to restrain the balloon body.  
     
     
         6 . A balloon as set forth in    claim 1   , wherein is included a seam in the body, said seam defining a restraint to restrain the balloon body.  
     
     
         7 . A balloon as set forth in    claim 1   , wherein is included a number of strings extending between the sides of the body, said strings defining at least part of a restraint to restrain the balloon body.  
     
     
         8 . A balloon as set forth in    claim 1   , wherein is included internal meshwork, said meshwork defining at least part of a restraint co restrain the balloon body.  
     
     
         9 . A balloon as set forth in    claim 1   , wherein is included external meshwork, said meshwork defining at least part of a restraint to restrain the balloon body.  
     
     
         10 . A balloon as set forth in    claim 1   , wherein said body is of a material capable of withstanding fluid pressures within the cortical bone of 50 to 400 psi.  
     
     
         11 . A balloon as set forth in    claim 1   , wherein said body has an outer surface adapted to assume the normal configuration of the inner surface of the cortical bone for compressing cancellous bone in a human lumbar vertebral body.  
     
     
         12 . A balloon as set forth in    claim 11   , wherein said body has a height in the range of  0 . 5  centimeter to  3 . 5  centimeters, there being an anterior-to-posterior dimension in the range of 0.5 centimeters to 3.5 centimeters, the side-to-side dimension of the body being in the range of 0.5 centimeters to 5.0 centimeters.  
     
     
         13 . A balloon as set forth in    claim 1   , wherein the body has an outer surface adapted to assume the normal configuration of the inner surface of the cortical bone for compressing cancellous bone in the human thoracic vertebral body.  
     
     
         14 . A balloon as set forth in    claim 13   , wherein said body has a height in the range of 0.5 to 3.5 centimeters, and having an anterior-to-posterior dimension in the range of 0.5 to 3.5 centimeters, and having a side-to-side dimension in the range of 0.5 to 3.5 centimeters.  
     
     
         15 . A balloon as set forth in    claim 1   , wherein said body has an outer surface adapted to assume the normal configuration of the inner surface of the cortical bone for compressing cancellous bone for compressing cancellous bone in the human distal radius.  
     
     
         16 . A balloon as set forth in    claim 15   , wherein said body has a proximal end whose dimensions range from 0.5 ×0.5 to 1.8×1.8 cm, whose length ranges from 1.0 to 12.0 cm, whose widest medial lateral dimension ranges from 1.0 to 2.5 cm and whose distal anterior-posterior dimension ranges from 0.5 to 3.0 cm.  
     
     
         17 . A balloon as set forth in    claim 1   , wherein the body has an outer surface adapted to assume the normal configuration of the inner surface of the cortical bone for compressing cancellous bone in a human tibial plateau.  
     
     
         18 . A balloon as set forth in    claim 17   , wherein said body has a height ranging from 0.5 to 5.0 cm, the anterior-posterior dimension ranging from 1.0 to 6.0 cm, and the medial and lateral dimension ranging from 1.0 to 6.0 cm.  
     
     
         19 . A balloon as set forth in    claim 11   , wherein said body has an outer surface adapted to assume the normal configuration of the inner surface of the cortical bone for compressing cancellous bone in the proximal humerus.  
     
     
         20 . A balloon as set forth in    claim 12   , wherein said body has a spherical portion whose dimensions vary from 1.0×1.0 cm to 3.0×3.0 cm, whose neck will range from 0.8×0.8 cm to 3.0×3.0 cm, the width of the base portion ranging from 0.5×0.5 cm to 2.5 by 2.5 cm, and whose length ranges from 4.0 to 14.0 cm.  
     
     
         21 . A balloon as set forth in    claim 11   , wherein said body has an outer surface adapted to assume the normal configuration of the inner surface of the cortical bone for compressing cancellous bone in the femoral head.  
     
     
         22 . A balloon as set forth in    claim 12   , wherein said body has a diameter ranging from 1.0 to 4.5 cm.  
     
     
         23 . A balloon as set forth in    claim 1   , wherein the material of the body is taken from the group consisting of Kevlar and polyethylene tetraphthalate (PET).  
     
     
         24 . A balloon as set forth in    claim 1   , wherein said balloon is doughnut shaped.  
     
     
         25 . A balloon as set forth in    claim 1   , wherein said balloon body includes a central part having a substantially spherical outer surface and a ring-shaped part surrounding the spherical part.  
     
     
         26 . A balloon as set forth in    claim 25   , wherein the part is spherical.  
     
     
         27 . A balloon as set forth in    claim 25   , wherein the part is hemispherical.  
     
     
         28 . A balloon as set forth in    claim 1   , including a number of elongated balloon units defining said balloon body, and restraint means coupling the balloon units together to restrict the expansion thereof in the direction transverse to the longitudinal axes of the units.  
     
     
         29 . A balloon as set forth in    claim 1   , wherein the balloon is formed of a pair of hollow, stacked inflatable parts, each part having a pair of opposed faces, and means bonding the adjacent faces of the parts together.  
     
     
         30 . A balloon as set forth in    claim 29   , wherein the balloon parts have a substantially circular outer periphery.  
     
     
         31 . A balloon as set forth in    claim 29   , wherein the balloon parts are doughnut shaped.  
     
     
         32 . A balloon as set forth in    claim 29   , wherein is included a catheter tube between said balloon parts for removing fats and debris.  
     
     
         33 . A balloon as set forth in    claim 1   , wherein the balloon is kidney bean shaped.  
     
     
         34 . A balloon as set forth in    claim 1   , wherein the balloon has a number of restraints interconnecting the end walls to limit expansion.  
     
     
         35 . A balloon as set forth in    claim 1   , wherein the end walls of said balloon has a number of interconnected parts defining transversely circular, generally cylindrical compartments.  
     
     
         36 . A balloon as set forth in    claim 1   , wherein the balloon is kidney bean shaped and has a number of spaced strings extending between the opposed sides of the balloon, said strings defining restraints.  
     
     
         37 . A balloon as set forth in    claim 1   , wherein said balloon body includes a pair of stacked doughnut shaped members, each member having a pair of opposed sides, a string extending between each pair of sides, respectively, to present a restraint for the balloon body.  
     
     
         38 . A balloon as set forth in    claim 1   , wherein the balloon body is spherical  
     
     
         39 . A balloon as set forth in    claim 1   , wherein the balloon body approximates a hemisphere.  
     
     
         40 . A balloon as set forth in    claim 1   , wherein the balloon body approximates a pyramid.  
     
     
         41 . A balloon as set forth in    claim 1   , wherein a portion is modified to further compress cancellous bone.  
     
     
         42 . A balloon as set forth in    claim 41   , wherein the modification is designed to compress cancellous bone into the shaft of a long bone.  
     
     
         43 . A balloon as set forth in    claim 42   , wherein the balloon body has a base.  
     
     
         44 . A balloon as set forth in    claim 43   , wherein the balloon body is a sphere on a base.  
     
     
         45 . A balloon as set forth in    claim 40   , wherein the balloon body approximates the shape of a banana.  
     
     
         46 . A balloon as set forth in    claim 45   , wherein the balloon body approximates the shape of a humpback banana.  
     
     
         47 . A balloon as set forth in    claim 1   , wherein a suction device is attached to remove debris.  
     
     
         48 . A balloon as set forth in    claim 1   , wherein the balloon body is protected from puncture during inflation by a guard member that covers the cortical bone and extends into the cancellous bone without preventing the balloon from inflating.  
     
     
         49 . A non-expandable balloon device suitable for compressing cancellous bone comprising: 
 a hollow, flexible, inflatable, non-expandable balloon body having a shape approximating a configuration taken from the group including a square, a rectangle, an oblong member and a cylinder, said body having a shape, when substantially fully expanded, to form a pair of sides, said body having restraints operable to cause the sides to be substantially parallel with each other when inflated.    
     
     
         50 . A device as set forth in    claim 49    wherein said body has a number of corners, said corners defining at least one of the restraints.  
     
     
         51 . A device as set forth in    claim 49    wherein said body includes a number of stacked body parts having means for coupling the body parts together, the coupling means of said body parts defining the restraint.  
     
     
         52 . A device as set forth in    claim 49    wherein is included walls with additional thickness in the body, said thickness defining the restraints.  
     
     
         53 . A device as set forth in    claim 49    wherein is included a number of strings extending between the sides of the balloon body, said strings defining said restraints.  
     
     
         54 . A device as set forth in    claim 49   , wherein is included a winding, said winding creating a restraint.  
     
     
         55 . A device as set forth in    claim 49   , wherein is included a meshwork, said meshworking created by a restraint.  
     
     
         56 . A device as set forth in    claim 49   , wherein is included bonding of portions of the body, said bonding creating a restraint.  
     
     
         57 . A device as set forth in    claim 49    wherein the material of the body is taken from the group consisting of polyethylene tetraphthalate (PET) or Kevlar.  
     
     
         58 . A balloon as set forth in    claim 49   , wherein a suction device is attached.  
     
     
         59 . A balloon as set forth in    claim 49   , wherein the balloon body is covered by a guard member.  
     
     
         60 . An inflatable device for insertion into a cortical bone to be treated for cavity formation and for compacting the bone marrow and trabecular bone thereof comprising: 
 a balloon body having flexible non-expandable wall means for conforming to the shape of the inner cortical surface of the bone to be treated, said wall means including a generally continuous side wall and a pair of opposed end walls integral with the side wall, said balloon having a fluid duct for directing an inflating liquid into the balloon, whereby the balloon can be inflated, said walls extending outwardly and into engagement with the inner surface of the bone to be treated and into compacting relationship to the cancellous bone.    
     
     
         61 . An inflatable device as set forth in    claim 60   , wherein is included restraints, the end walls of the balloon being held by said restraints when the balloon body is inflated.  
     
     
         62 . An inflatable device as set forth in    claim 60   , wherein the side wall of the balloon body is held together by restraints.  
     
     
         63 . An inflatable device as set forth in    claim 60   , wherein said balloon is doughnut shaped.  
     
     
         64 . An inflatable device as set forth in    claim 60   , wherein said balloon body includes a central, substantially spherical part and a ring-shaped part surrounding the spherical part.  
     
     
         65 . An inflatable device as set forth in    claim 60   , is included a number of elongated balloon units defining said balloon, and restraint means coupling the balloon units together to restrict the expansion thereof in the direction transverse to the longitudinal axes of the units.  
     
     
         66 . An inflatable device as set forth in    claim 60   , wherein the balloon body is formed of a pair of hollow, stacked inflatable parts, each part having a pair of opposed sides and means bonding the adjacent sides of the parts together as a unit.  
     
     
         67 . An inflatable device as set forth in    claim 44   , wherein the balloon parts have a circular outer periphery.  
     
     
         68 . An inflatable device as set forth in    claim 44   , wherein the balloon parts are doughnut shaped.  
     
     
         69 . An inflatable device as set forth in    claim 44   , wherein is included a catheter tube between said balloon parts for removing fats and debris from a location between said parts.  
     
     
         70 . An inflatable device as set forth in    claim 60   , wherein the balloon is kidney shaped.  
     
     
         71 . An inflatable device as set forth in    claim 60   , wherein the balloon has a number of restraints interconnecting the end walls to limit expansion.  
     
     
         72 . An inflatable device as set forth in    claim 60   , wherein the end walls of said balloon has a number of interconnected parts defining transversely circular, cylindrical compartments.  
     
     
         73 . An inflatable device as set forth in    claim 60   , wherein the balloon is kidney shaped and has a number of spaced strings extending between the opposed sides of the balloon, said strings defining restraints.  
     
     
         74 . An inflatable device as set forth in    claim 60   , wherein said balloon includes a pair of stacked doughnut shaped members, each member having a pair of opposed sides, a string extending between each pair of sides, respectively, to present restraints for the balloon.  
     
     
         75 . An inflatable device as set forth in    claim 60   , wherein the balloon body is pyramid-shaped.  
     
     
         76 . A method for treating a bone predisposed to fracture or to collapse, or fractured or collapsed, comprising: 
 providing a hollow, collapsible, inflatable, non-expandable cavity former;    inserting the cavity former while collapsed into said bone with said cavity former having a predetermined shape and size, when substantially fully inflated;    inflating the cavity former to a sufficient fluid pressure to compress at least a portion of the inner cancellous bone;    forming a cavity in the cancellous bone as a function of the inflating step wherein said cavity will have the predetermined shape and size appropriate for the bone to be treated; and    restraining the cavity former to create said predetermined shape and size, preventing the cavity former from applying excessive pressure to the inner surface of the cortical bone if said bone is unfractured or uncollapsed.    
     
     
         77 . A method as set forth in    claim 76   , wherein said restraining step includes forming substantially parallel sides for said cavity former when the space has been inserted in the cortical bone.  
     
     
         78 . A method as set forth in    claim 76   , wherein said cavity former is capable of withstanding internal fluid pressures within the cortical bone of 50 to 400 psi.  
     
     
         79 . A method as set forth in    claim 76   , wherein said inserting step includes placing the cavity former in the distal radius to adapt the cavity for use in treating a radius fracture.  
     
     
         80 . A method as set forth in    claim 76   , wherein said inserting step includes placing the cavity former in the proximal tibia to adapt the cavity for use in treating a tibial fracture.  
     
     
         81 . A method as set forth in    claim 76   , wherein the inserting step includes placing the cavity former in the proximal humerus to adapt the cavity for use in treating a proximal humerus fracture.  
     
     
         82 . A method as set forth in    claim 76   , wherein the inserting step includes placing the cavity former in the femoral head to adapt the cavity for use in treating necrosis of the femoral head.  
     
     
         83 . A method as set forth in    claim 76   , wherein the inserting step includes placing the cavity former in the vertebral body for treating a vertebral body fracture.  
     
     
         84 . A method as set forth in    claim 76   , wherein the restraining step includes providing a winding bonded to the cavity former to reinforce critical areas of the circumference of the cavity former.