Neurological stimulator system with detachable lead connection arrangement and related methods

Abstract

A neural stimulation system may include an electrode lead(s) having a proximal end and a distal end, with the electrode lead(s) including a plurality of spaced apart electrodes carried by the distal end to be positioned adjacent a nerve(s) in a patient. A subcutaneous lead connector plug including a housing electrically connected to the proximal end of the electrode lead(s) may be positioned with the electrode lead(s) inside the patient beneath the patient's skin, with the housing defining a lead connection port(s), and an anchor point(s) carried by the housing. The system may also include a generator lead(s) having a distal end configured to be removably plugged into and electrically connected with the lead connector port(s), and a proximal end. A neural stimulation generator may be electrically connected to the proximal end of the generator lead(s) and configured to provide electrical stimulation to the nerve(s) via the plurality of electrodes.

That which is claimed is: 
     
         1 . A neural stimulation system comprising:
 at least one electrode lead having a proximal end and a distal end, the at least one electrode lead comprising a plurality of spaced apart electrodes carried by the distal end to be positioned adjacent at least one nerve in a patient;   a subcutaneous lead connector plug comprising
 a housing electrically connected to the proximal end of the at least one electrode lead to be positioned with the at least one electrode lead inside the patient beneath the patient's skin, the housing defining at least one lead connection port, and 
 at least one anchor point carried by the housing to be connected to tissue beneath the patient's skin; 
   at least one generator lead having a distal end configured to be removably plugged into and electrically connected with the at least one lead connector port, and a proximal end; and   a neural stimulation generator to be electrically connected to the proximal end of the at least one generator lead and configured to provide electrical stimulation to the at least one nerve via the plurality of electrodes.   
     
     
         2 . The neural stimulation system of  claim 1  wherein the at least one lead connection port comprises a respective lead connection port for the proximal end of the at least one electrode lead and for the distal end of the at least one generator lead; and wherein the proximal end of the at least one electrode lead is to be removably plugged into and electrically connected with its respective lead connection port. 
     
     
         3 . The neural stimulation system of  claim 1  wherein the at least one electrode lead and the subcutaneous lead connector plug are integrally formed. 
     
     
         4 . The neural stimulation system of  claim 1  wherein the at least one electrode lead comprises a pair of electrode leads. 
     
     
         5 . The neural stimulation system of  claim 1  wherein the at least one anchor point comprises at least one anchor loop carried by the housing. 
     
     
         6 . The neural stimulation system of  claim 1  wherein the at least one anchor point comprises a plurality of anchor points spaced apart along the housing. 
     
     
         7 . The neural stimulation system of  claim 1  wherein the at least one lead connection port comprises at least one female lead connection port, and wherein the distal end of the at least one generator lead defines a corresponding male connection plug for the at least one female lead connection port. 
     
     
         8 . The neural stimulation system of  claim 1  wherein the subcutaneous lead connector plug further comprises at least one set screw carried by the housing to secure the distal end of the at least one generator lead within the at least one lead connector port. 
     
     
         9 . The neural stimulation system of  claim 1  wherein the at least one electrode lead comprises at least one percutaneous lead. 
     
     
         10 . A subcutaneous stimulator lead device comprising:
 at least one electrode lead having a proximal end and a distal end, the at least one electrode lead comprising a plurality of spaced apart electrodes carried by the distal end to be positioned adjacent at least one nerve in a patient; and   a subcutaneous lead connector plug comprising
 a housing integrally formed with the least one electrode lead and electrically connected to the proximal end thereof to be positioned with the at least one electrode lead inside a patient beneath the patient's skin, the housing defining at least one lead connection port, and 
 at least one anchor point carried by the housing to be connected to tissue beneath the patient's skin; 
   wherein the at least one lead connection port is configured to receive at least one generator lead having a distal end configured to be removably plugged into and electrically connected with the at least one lead connector port, and also having a proximal end configured to be electrically connected to a neural stimulation generator that is configured to provide electrical stimulation to the at least one nerve via the plurality of electrodes.   
     
     
         11 . The subcutaneous stimulator lead device of  claim 10  wherein the at least one electrode lead comprises a pair of electrode leads. 
     
     
         12 . The subcutaneous stimulator lead device of  claim 10  wherein the at least one anchor point comprises at least one anchor loop carried by the housing. 
     
     
         13 . The subcutaneous stimulator lead device of  claim 10  wherein the at least one anchor point comprises a plurality of anchor points spaced apart along the housing. 
     
     
         14 . A subcutaneous lead connector plug comprising:
 a housing to be positioned inside a patient beneath the patient's skin, the housing defining a plurality of lead connector ports; and   at least one anchor point carried by the housing to be connected to tissue beneath the patient's skin;   wherein a first one of the lead connector ports is configured to receive an electrode lead having a proximal end configured to be removably plugged into and electrically connected with the first lead connector port, the electrode lead comprising a plurality of spaced apart electrodes carried by a distal end thereof to be positioned adjacent at least one nerve in the patient;   wherein a second one of the lead connector ports is configured to receive a generator lead having a distal end configured to be removably plugged into and electrically connected with the second lead connector port, the generator lead also having a proximal end configured to be connected to a neural stimulation generator that is configured to provide electrical stimulation to the at least one nerve via the plurality of electrodes.   
     
     
         15 . The subcutaneous lead connector plug of  claim 14  wherein the at least one anchor point comprises at least one anchor loop carried by the housing. 
     
     
         16 . The subcutaneous lead connector plug of  claim 14  wherein the at least one anchor point comprises a plurality of anchor points spaced apart along the housing. 
     
     
         17 . A neural stimulation method comprising:
 using at least one electrode lead having a proximal end and a distal end and comprising a plurality of spaced apart electrodes carried by the distal end, positioning the distal end of the at least one electrode lead so that the electrodes are adjacent at least one nerve in a patient;   using a subcutaneous lead connector plug comprising a housing electrically connected to the proximal end of the at least one electrode lead and defining at least one lead connection port, and at least one anchor point carried by the housing, positioning the housing along with the proximal end of the at least one electrode lead inside the patient beneath the patient's skin;   connecting the at least one anchor point to tissue beneath the patient's skin;   using a first generator lead having a distal end and a proximal end, plugging the distal end of the first generator lead into the at least one lead connector port to electrically connect the distal end of the second lead with the at least one lead connector port; and   connecting the proximal end of the first generator lead to a first neural stimulation generator, and operating the first neural stimulation generator to provide electrical stimulation to the at least one nerve via the plurality of electrodes.   
     
     
         18 . The neural stimulation method of  claim 17  wherein the first neural stimulation generator comprises an external neural stimulation generator outside of the patient's body; wherein operating the external neural stimulation generator comprises operating the external neural stimulation generator during a trial period; and further comprising unplugging the distal end of the first generator lead from the at least one lead connector port after the trial period while leaving the at least one electrode lead and the subcutaneous lead connector plug inside the patient. 
     
     
         19 . The neural stimulation method of  claim 18  further comprising, after the trial period:
 plugging a distal end of a second generator lead into the at least one lead connector port to provide an electrical connection therewith; 
 electrically connecting a proximal end of the second generator lead to an internal neural stimulation generator; and 
 implanting the second generator lead and the internal neural stimulation generator inside of the patient's body so that the internal neural stimulation generator provides electrical stimulation to the at least one nerve via the plurality of electrodes during an extended use period. 
 
     
     
         20 . The neural stimulation method of  claim 17  wherein the at least one lead connection port comprises a respective lead connection port for the proximal end of the at least one electrode lead, and for the distal ends of the first and second generator leads; and further comprising plugging the proximal end of the at least one electrode lead into its respective lead connection port to provide an electrical connection therewith. 
     
     
         21 . The neural stimulation method of  claim 17  wherein the at least one electrode lead and the subcutaneous lead connector plug are integrally formed. 
     
     
         22 . The neural stimulation method of  claim 17  wherein the at least one electrode lead comprises a pair of electrode leads. 
     
     
         23 . The neural stimulation method of  claim 17  wherein the at least one anchor point comprises at least one anchor loop carried by the housing; and wherein connecting the at least one anchor point comprises connecting the at least one anchor point to tissue beneath the patient's skin. 
     
     
         24 . The neural stimulation method of  claim 17  wherein the at least one anchor point comprises a plurality of anchor points spaced apart along the housing. 
     
     
         25 . The neural stimulation method of  claim 17  wherein positioning the distal end of the at least one electrode lead comprises inserting the distal end of the at least one electrode lead percutaneously.