Spinal Balloon Systems Comprising Microbubbles

Abstract

Adding gas-filled microbubbles to both the saline solution of either a kyphoplasty balloon or a vertebroplasty cement allows the clinician to assess via ultrasound both the location and expansion of the balloon and the location of the cement during vertebral body augmentation procedures without the use of fluoroscopy.

I claim: 
     
         1 . A system comprising:
 a) an inflated balloon having an opening;   b) a tube connected to the opening;   c) a fluid disposed within the inflated balloon; and   d) a plurality of microbubbles dispersed within the fluid.   
     
     
         2 . The system of  claim 1  wherein the plurality of microbubbles is present in a concentration of between 1 to 10 million microbubbles/ml of the fluid. 
     
     
         3 . The system of  claim 1  wherein the microbubbles comprise a phospholipid. 
     
     
         4 . The system of  claim 1  wherein the fluid is saline. 
     
     
         5 . A tool comprising an outer tube having a distal end, an catheter tube extending within the outer tube and having a distal end region that extends beyond the distal end of the outer tube, and an expandable structure having a proximal end secured to the distal end of the outer tube and a distal end secured to the distal end region of the inner tube, whereby the distal end region of the inner tube is enclosed within the expandable structure, wherein the inner tube is filled with a fluid, wherein a plurality of microbubbles are disposed within the fluid of the inner tube. 
     
     
         6 . The tool of  claim 5  wherein the plurality of microbubbles is present in a concentration of between 1 to 10 million microbubbles/ml of the fluid. 
     
     
         7 . A tool comprising an outer tube having a distal end, an catheter tube extending within the outer tube and having a distal end region that extends beyond the distal end of the outer tube, and an expandable structure having a proximal end secured to the distal end of the outer tube and a distal end secured to the distal end region of the inner tube, whereby the distal end region of the inner tribe is enclosed within the expandable structure, wherein the expandable structure is filled with a fluid, wherein a plurality of microbubbles are disposed within the fluid of the expandable structure. 
     
     
         8 . The tool of  claim 7  wherein the plurality of microbubbles is present in a concentration of between 1 to 10 million microbubbles/ml of the fluid. 
     
     
         9 . A method for treating spinal tissue comprising the steps of:
 a) providing a tool comprising an outer tube having a distal end, an inner tube extending within the outer catheter tube and having a distal end region that extends beyond the distal end of the outer tube, and an expandable structure having a proximal end secured to the distal end of the outer tube and a distal end secured to the distal end region of the inner tube, whereby the distal end region of the inner tube is enclosed within the expandable structure, wherein a first plurality of microbubbles are disposed with the inner tube in a first fluid and a second plurality of microbubbles are disposed within the expandable structure in a second fluid,   b) manipulating the tool to introduce the expandable structure into bone while in a generally collapsed geometry,   c) applying ultrasound to assess a location of the inner catheter,   d) causing the expandable structure to assume an expanded geometry inside the tissue, and   e) applying ultrasound to assess a location of the expandable structure.