Ultrasound device for treatment of intervertebral disc tisssue

Abstract

An ultrasound device and method for the treatment of intervertebral disc tissue for remediation of back pain. An applicator comprises a catheter and/or needle with a distal tip including one or more ultrasound transducer crystals. The crystals produce high-powered ultrasound energy that is transmitted and absorbed in the disc tissue. The resulting temperature elevation of the disc tissue shrinks the collagen fibers in the surrounding tissue, and/or destroying small nerves that may have invaded and innervated the surrounding degenerated tissue, and can provide increased structural integrity and disc support for the fragmented nucleus pulposus to relieve pressure on the spinal nerves.

1 . A minimally invasive applicator device including an ultrasound transducer for treatment of intervertebral disc tissue, comprising: 
 an insertion device having a proximal end and a distal end for insertion into the intervertebral disc tissue, the insertion device being structurally robust for direct insertion into a targeted area of intervertebral disc tissue without damage or misalignment;    an ultrasound transducer crystal to provide thermal treatment coupled to the distal end of the insertion device;    an external electrical RF power generator electrically connected to the ultrasound transducer, the generator providing power to the ultrasound transducer which outputs ultrasound energy for the thermal treatment of the invertebral tissue;    wherein the insertion device comprises a catheter or needle;    wherein the ultrasound transducer crystal includes at least one individual electrical power connection and control element;    a thermocouple having a sensor placed within the intervertebral disc tissue to monitor the temperature of the intervertebral disc tissue; and    wherein the insertion device is configured for deploying the thermocouple sensor into the intervertebral disc tissue.    
   
   
       2 . The device of  claim 1 , wherein a plurality of transducer crystals are aligned to form an array along the applicator device, wherein each transducer crystal includes an individual electrical power connection.  
   
   
       3 . The device of  claim 1 , wherein the ultrasound transducer crystal has a cylindrical shape to transmit radially dispersive or radially focused ultrasound energy.  
   
   
       4 . The device of  claim 1 , wherein the ultrasound transducer crystal is substantially planar.  
   
   
       5 . The device of  claim 1 , wherein the ultrasound transducer crystal is sectioned electrically and/or mechanically to provide separate active elements within a single ultrasound transducer crystal.  
   
   
       6 . The device of  claim 1 , further comprising a thermocouple placed on or adjacent to the ultrasound transducer crystal, the thermocouple monitoring the surface temperature of the device and/or the temperature of the tissue/device interface.  
   
   
       7 . The device of  claim 1 , further comprising means to cool the internal transducer heating by circulating a flow of a liquid or gaseous coolant through the applicator.  
   
   
       8 . The device of  claim 1 , further comprising a guidewire coupled to the applicator, wherein the applicator is flexible and can be directed or steered by the guidewire in a specific direction within the intervertebral disc tissue.  
   
   
       9 . The device of  claim 1 , further comprising a separate insertion tool or sheath for introduction into the intervertebral disc tissue, and wherein the applicator is inserted into the tissue through the lumen of the insertion tool or sheath.  
   
   
       10 . The device of  claim 9 , wherein the insertion tool comprises a predetermined fixed shape, and wherein the applicator is flexible to accommodate the fixed shape in its passage into the intervertebral disc tissue.  
   
   
       11 . The device of  claim 1 , wherein the distal end of the applicator device is fixedly curved to provide enhanced accessibility of the ultrasound transducer to the posterior region of the intervertebral disc.  
   
   
       12 . The device of  claim 1 , wherein the ultrasound applicator device is also configured to provide diagnostic ultrasound imaging of the intervertebral disc tissue and surrounding tissue to guide and monitor the treatment process.  
   
   
       13 . A minimally invasive applicator device including an ultrasound transducer for thermal treatment and imaging of intervertebral disc tissue, comprising: 
 an insertion device having a proximal end and a distal end for insertion into the intervertebral disc tissue, the insertion device being structurally robust for direct insertion into a targeted area of intervertebral disc tissue without damage or misalignment;    an ultrasound transducer crystal to provide thermal treatment of the intervertebral disc tissue and coupled to the distal end of the insertion device; and    an external RF power generator electrically connected to the ultrasound transducer, the generator providing power to the ultrasound transducer which then generates high-powered ultrasound energy to be absorbed by the disc tissue; and means for receiving a diagnostic ultrasound signal; and    wherein the ultrasound applicator device is configured also to provide diagnostic ultrasound imaging of the intervertebral disc tissue and surrounding tissue to guide and monitor the treatment process in real time.    
   
   
       14 . The device of  claim 13 , wherein a plurality of transducer crystals are aligned to form an array along the applicator device, wherein each transducer crystal includes an individual electrical power connection.  
   
   
       15 . The device of  claim 13 , wherein the ultrasound transducer crystal is sectioned electrically and/or mechanically to provide separate active elements within a single ultrasound transducer crystal.  
   
   
       16 . The device of  claim 13 , further comprising a thermocouple placed on or adjacent to the ultrasound transducer crystal, the thermocouple monitoring the surface temperature of the device and/or the temperature of the tissue/device interface.  
   
   
       17 . A method for thermally treating intervertebral degenerated disc tissue, comprising the steps of: 
 inserting, positioning and guiding an ultrasound applicator device into intervertebral disc tissue via diagnostic imaging;    applying power to at least one ultrasound transducer in the ultrasound applicator device, the at least one ultrasound transducer heating a designated area of the intervertebral disc tissue;    removing the applicator device from the intervertebral disc tissue; and    heating an entrance hole with the ultrasound applicator device in order to produce thermal sealing or shrinking of the tissue upon removal of the applicator.    
   
   
       18 . The method of  claim 17 , wherein the diagnostic imaging technique used for positioning and guiding the applicator device is comprised of at least one of intra-operative fluoroscopy, CT, MR, ultrasound, laparoscopy, and endoscopy.  
   
   
       19 . The method of  claim 17 , wherein the diagnostic imaging comprises ultrasound imaging provided by a transducer crystal located within the applicator device.  
   
   
       20 . The method of  claim 17 , further comprising the step of measuring the temperature on the applicator device and/or in the surrounding tissue.  
   
   
       21 . A system for thermally treating intervertebral disc tissue, comprising the steps of: 
 an ultrasound applicator device insertable into intervertebral disc tissue;    at least one ultrasound transducer included in the ultrasound applicator device, the at least one ultrasound transducer for heating an area of the intervertebral disc tissue; and    therapeutic agent insertable into the intervertebral disc tissue to enhance the effect of the thermal energy from the ultrasound applicator device.    
   
   
       22 . The system of  claim 21 , further including a diagnostic imaging system used for positioning and guiding the applicator device, the device comprised of at least one of intra-operative fluoroscopy, CT, MR, ultrasound, laparoscopy, and endoscopy.  
   
   
       23 . The system of  claim 21 , further comprising a device for measuring the temperature on the applicator device and/or in the surrounding tissue.