Percutaneous electrical therapy system with sharp point protection

Abstract

The invention is a percutaneous electrical therapy system with sharp point protection. In a preferred embodiment, the system includes a control unit; an electrode assembly adapted to deliver electrical therapy to a patient, where the electrode assembly has an electrode electrically connectable to the control unit, the electrode having a sharp point at a distal end adapted to be inserted into the patient's tissue; and a sharp point protection assembly operable with the electrode assembly for reducing risk of unintended exposure to the electrode's point. The invention also includes an electrode assembly and sharp point protection assembly for a percutaneous electrical therapy system as described above, apart from the control unit. The invention is also a method of performing percutaneous electrical therapy, the method including the steps of providing an electrode assembly having an electrode, the electrode having a sharp point at a distal end; inserting the sharp point of the electrode into a patient's tissue without exposing the sharp point to anyone but the patient; and applying an electrical signal to the electrode from a control unit.

What is claimed is:  
     
         1 . A percutaneous electrical therapy system comprising: 
 a control unit;    an electrode assembly adapted to deliver electrical therapy to a patient, the electrode assembly comprising an electrode electrically connectable to the control unit, the electrode comprising a sharp point at a distal end adapted to be inserted into the patient's tissue; and    a sharp point protection assembly operable with the electrode assembly for reducing risk of unintended exposure to the electrode's point.    
     
     
         2 . The system of  claim 1  wherein the sharp point protection assembly comprises a housing to contain at least the sharp point of the electrode when the electrode is in an undeployed state.  
     
     
         3 . The system of  claim 2  wherein the sharp point of the electrode is outside of the housing in a deployed state, the housing being adapted to contain a portion of the electrode in the deployed state.  
     
     
         4 . The system of  claim 3  wherein the housing is adapted to contain at least the sharp point of the electrode after the electrode has changed from the deployed state to an undeployed state.  
     
     
         5 . The system of  claim 2  wherein the sharp point protection assembly further comprises a locking assembly preventing relative movement between the electrode and the housing.  
     
     
         6 . The system of  claim 5  wherein the locking assembly comprises a spring-biased detent.  
     
     
         7 . The system of clam  5  further comprising a tool adapted to release the locking assembly and to move the sharp point of the electrode out of the housing.  
     
     
         8 . The system of  claim 7  wherein the tool is further adapted to move the sharp point of the electrode back into the housing after having moved the sharp point of the electrode out of the housing and to engage the locking assembly to prevent further relative movement between the electrode and the housing.  
     
     
         9 . The system of  claim 2  wherein the electrode assembly further comprises an actuator attached to a proximal end of the electrode, the actuator being disposed within and movable within the housing.  
     
     
         10 . The system of  claim 9  further comprising an actuator tool adapted to interact with the actuator to move the sharp point of the electrode out of the housing.  
     
     
         11 . The system of  claim 10  wherein the actuator tool is further adapted to move the sharp point of the electrode back into the housing after having moved the sharp point of the electrode out of the housing.  
     
     
         12 . The system of  claim 11  wherein the actuator tool has an electrical contact adapted to make electrical communication between the electrode and the control unit.  
     
     
         13 . The system of  claim 10  further comprising a locking assembly preventing relative movement between the actuator and the housing, the actuator tool being adapted to release the locking mechanism and to move the sharp point of the electrode out of the housing.  
     
     
         14 . The system of  claim 2  wherein the housing is adapted to contain none of the electrode when the electrode is in a deployed state in which the sharp point of the electrode has been inserted into the patient's tissue.  
     
     
         15 . The system of  claim 14  wherein the housing is adapted to contain a plurality of electrodes.  
     
     
         16 . The system of  claim 14  further comprising an actuator adapted to move the electrode out of the housing.  
     
     
         17 . The system of  claim 16  wherein the housing is adapted to contain a plurality of electrodes, the actuator being further adapted to move each electrode out of the housing one at a time.  
     
     
         18 . The system of  claim 14  wherein the electrode assembly further comprises a patch adapted to be placed on the patient's skin and to support the electrode in the deployed state.  
     
     
         19 . The system of  claim 18  wherein the patch has an opening adapted to surround a portion of the electrode when the electrode is in the deployed state.  
     
     
         20 . The system of  claim 19  wherein the patch further comprises an annular member disposed in the patch opening and adapted to engage a handle portion of the electrode.  
     
     
         21 . The system of  claim 20  wherein the annular member comprises a raised portion disposed above the patch and adapted to engage an aperture of the housing.  
     
     
         22 . The system of  claim 14  further comprising an electrical connector attachable to the electrode handle portion to make electrical communication between the electrode and the control unit.  
     
     
         23 . The system of  claim 14  wherein the housing is a first housing, the sharp point protection assembly further comprising a second housing to contain at least the sharp point of the electrode when the electrode has moved from the deployed state to an undeployed state.  
     
     
         24 . The system of  claim 23  further comprising an actuator adapted to move the electrode into the second housing.  
     
     
         25 . The system of  claim 24  further comprising an electrode grasper adapted to grasp the electrode in response to movement of the actuator.  
     
     
         26 . The system of  claim 25  wherein the electrode grasper is a fork adapted to mate with a handle portion of the electrode.  
     
     
         27 . The system of  claim 23  wherein the second housing is adapted to contain at least the sharp points of a plurality of electrodes.  
     
     
         28 . The system of  claim 27  further comprising an actuator adapted to move a plurality of electrodes into the second housing.  
     
     
         29 . The system of  claim 2  wherein the sharp point protection assembly further comprises an aperture in the housing adapted to permit the electrode to pass through for deployment of the electrode.  
     
     
         30 . The system of  claim 1  further comprising a movable actuator adapted to move the sharp point of the electrode into the patient's tissue.  
     
     
         31 . The system of  claim 30  further comprising an actuator limit element limiting movement of the actuator and controlling depth of insertion of the sharp point of the electrode into the patient's tissue.  
     
     
         32 . The system of  claim 1  wherein the electrode assembly further comprises an electrode insertion depth control mechanism.  
     
     
         33 . The system of  claim 1  wherein the electrode assembly further comprises a deployed electrode holding mechanism adapted to hold the electrode in place after insertion of the sharp point of the electrode into the patient's tissue.  
     
     
         34 . The system of  claim 1  further comprising an electrode insertion axial stabilizer adapted to provide axial stability to the electrode during insertion of the sharp point of the electrode into the patient's tissue.  
     
     
         35 . The system of  claim 1  further comprising an electrode insertion pain reducer adapted to reduce pain experienced by the patient during insertion of the sharp point of the electrode into the patient's tissue.  
     
     
         36 . The system of  claim 1  further comprising an electrode angle of entry controller adapted to control the electrode's entry angle during insertion of the sharp point of the electrode into the patient's tissue.  
     
     
         37 . A method of performing percutaneous electrical therapy comprising: 
 providing an electrode assembly comprising an electrode, the electrode comprising a sharp point at a distal end;    inserting the sharp point of the electrode into a patient's tissue without exposing the sharp point to anyone but the patient; and    applying an electrical signal to the electrode from a control unit.    
     
     
         38 . The method of  claim 37  further comprising: 
 removing the electrode from the patient's tissue without exposing the sharp point to anyone but the patient.  
 
     
     
         39 . The method of  claim 37  further comprising: 
 making an electrical connection between the electrode and the control unit.  
 
     
     
         40 . The method of  claim 37  further comprising after the inserting step: 
 supporting the electrode in the patient's tissue.  
 
     
     
         41 . The method of  claim 37  wherein the inserting step comprises: 
 using the electrode assembly to guide electrode entry angle.  
 
     
     
         42 . The method of  claim 37  wherein the inserting step comprises: 
 using an introducer to guide electrode entry angle.  
 
     
     
         43 . The method of  claim 37  wherein the inserting step comprises: 
 providing axial stability to the electrode during insertion.  
 
     
     
         44 . The method of  claim 37  wherein the inserting step comprises: 
 placing a housing adjacent the patient's tissue; and  
 moving the sharp point of the electrode out of the housing and into the patient's tissue.  
 
     
     
         45 . The method of  claim 44  further comprising placing a patch on the patient's tissue prior to the step of placing a housing, the step of placing a housing comprising placing the housing adjacent the patch.  
     
     
         46 . The method of  claim 45  wherein the patch comprises an opening, the moving step comprising moving the sharp point of the electrode out of the housing, through the opening and into the patient's tissue.  
     
     
         47 . The method of  claim 45  further comprising: 
 mechanically supporting at least a portion of the electrode with the patch.  
 
     
     
         48 . The method of  claim 44  wherein the moving step comprises: 
 moving the entire electrode out of the housing; and  
 removing the housing from the patient's tissue.  
 
     
     
         49 . The method of  claim 48  wherein the housing comprises a first housing, the method further comprising: 
 removing the electrode from the patient's tissue into a second housing without exposing the sharp point to anyone but the patient.  
 
     
     
         50 . The method of  claim 44  further comprising removing the electrode from the patient's tissue into the housing without exposing the sharp point to anyone but the patient.  
     
     
         51 . An electrode assembly and sharp point protection assembly for a percutaneous electrical therapy system comprising: 
 an electrode assembly adapted to deliver electrical therapy to a patient, the electrode assembly comprising an electrode electrically connectable to the control unit, the electrode comprising a sharp point at a distal end adapted to be inserted into the patient's tissue; and    a sharp point protection assembly operable with the electrode assembly for reducing risk of unintended exposure to the electrode's point.