Implantable Electrical Stimulation Leads

Abstract

An implantable electrical stimulation lead for the treatment of biological conditions includes a lead body with an electrical connector at one end and a pair of monopolar branches at the other end. The lead body has a length ranging from 390 mm to 490 mm to allow for implantation from an incision site further removed from the final positioning site of the electrodes. The branches have lengths ranging from 50 mm to 120 mm for the both branches. These lengths facilitate successful laparoscopic implantation at sites with confined anatomy, such as, near the gastroesophageal junction. The branches include needles and sutures at their ends for suturing anchors positioned on the branches to surrounding tissue. The needles have curves designed to facilitate maneuvering in confined anatomy. A separate lead includes a suture loop connecting the ends of the first and second branches rather than needles. The loop is used to pull the lead through the working channel of an endoscope. The anchors on the lead are porous and allow for the ingrowth of surrounding tissue for fixing the branches in place.

We claim: 
     
         1 . An implantable electrical lead for use in the stimulation of biological tissues, said lead comprising:
 an elongate lead body having a proximal end and a distal end, said lead body comprising an electrically conductive inner coil, an electrically conductive outer coil, a first insulating sheath covering said inner coil, and a second insulating sheath covering said outer coil wherein said lead body has a length within a range of 390 mm to 490 mm;   a connector attached to and in electrical communication with said proximal end of said lead body;   a first elongate branch having a proximal end and a distal end, said first elongate branch comprising said inner coil and said first insulating sheath covering said inner coil and not comprising said outer coil and said second insulating sheath, wherein said first branch has a length within a range of 50 mm to 120 mm;   a second elongate branch having a proximal end and a distal end, said second elongate branch comprising said outer coil and said second insulating sheath covering said outer coil and not comprising said inner coil and said first insulating sheath, wherein said proximal end of said first branch and said proximal end of said second branch join to form said distal end of said lead body, wherein said second branch has a length within a range of 50 mm to 120 mm;   a first anchoring element and a first electrode attached to said first branch and positioned proximate said distal end of said first branch; and,   a second anchoring element and a second electrode attached to said second branch and positioned proximate said distal end of said second branch.   
     
     
         2 . The implantable electrical lead of  claim 1 , further comprising a first length of suturing material and a second length of suturing material, each having a proximal end and a distal end, wherein said proximal end of said first length of said suturing material is attached to said distal end of said first branch and said proximal end of said second length of said suturing material is attached to said distal end of said second branch. 
     
     
         3 . The implantable electrical lead of  claim 2 , wherein said first and second lengths of suturing material are each in a range of 55 to 65 mm. 
     
     
         4 . The implantable electrical lead of  claim 2 , further comprising a first needle attached to said distal end of said first length of suturing material and a second needle attached to said distal end of said second length of suturing material, wherein said first needle and said first length of suturing material are used to suture said first anchoring element to a biological tissue and said second needle and said second length of suturing material are used to suture said second anchoring element to a biological tissue. 
     
     
         5 . The implantable electrical lead of  claim 4 , wherein said first and second needles are each within a range of ¼ to ⅜ of a circle curve needles with a length ranging from 18 to 23 mm and include a base having a diameter in a range of 0.68 mm to 0.78 mm. 
     
     
         6 . The implantable electrical lead of  claim 1 , wherein a distal end of said outer coil is positioned at said distal end of said lead body, said lead further comprising an additional electrically conductive coil having a proximal end and a distal end and comprising said second branch, wherein said proximal end of said additional coil is attached to said distal end of said outer coil and said second anchoring element and said second electrode are attached to and positioned proximate said distal end of said additional coil and said second insulating sheath extends over said additional coil. 
     
     
         7 . The implantable electrical lead of  claim 1 , further comprising a sleeve covering the distal end of said lead body and the proximal ends of said first branch and said second branch. 
     
     
         8 . The implantable electrical lead of  claim 1 , further comprising a marking element on said first branch to serve as a visual indicator. 
     
     
         9 . The implantable electrical lead of  claim 1 , wherein said first insulating sheath extends over a proximal portion of said first electrode and said second insulating sheath extends over a proximal portion of said second electrode such that, after said lead is implanted, said insulating sheaths are pulled partially in a proximal direction to expose said proximal portions of said electrodes. 
     
     
         10 . The implantable electrical lead of  claim 9 , wherein said first and second insulating sheaths extend in a range of 1 to 5 mm over said first and second electrodes. 
     
     
         11 . The implantable electrical lead of  claim 9 , wherein, after said lead is implanted, a total exposed length of said electrodes is in a range of 1 to 10 mm. 
     
     
         12 . A lead delivery catheter to be used with an endoscope or a laparoscope and for implanting the electrical stimulation lead of  claim 1  in the body of a patient, said catheter comprising:
 a catheter body having a proximal end, a distal end, and a lumen within; 
 an inflatable balloon attached to said distal end of said catheter body; and, 
 a grasping mechanism attached to said distal end of said catheter body for grasping said lead. 
 
     
     
         13 . The catheter of  claim 12 , further comprising a light source providing illumination at its distal end. 
     
     
         14 . The catheter of  claim 12 , further comprising a camera at its distal end. 
     
     
         15 . The catheter of  claim 12 , further comprising a bipolar electrocautery electrode at its distal end. 
     
     
         16 . The catheter of  claim 15 , wherein said bipolar electrocautery electrode is incorporated into said grasping mechanism. 
     
     
         17 . An implantable electrical lead for use in the stimulation of biological tissues, said lead comprising:
 a Y shaped structure comprising a central portion, having a proximal end and a distal end, a first prong, and a second prong, each prong having a proximal end and a distal end, wherein said proximal ends of said first and second prongs join together to form said distal end of said central portion, further wherein:
 said central portion comprises an electrically conductive inner coil covered by a first insulating sheath and an electrically conductive outer coil covered by a second insulating sheath, wherein said outer coil covered by said second insulating sheath is positioned coaxially over said inner coil covered by said first insulating sheath and said central portion has a length within a range of 390 mm to 490 mm, further wherein a connector is attached to and in electrical communication with said proximal end of said central portion; 
 said first prong comprises said inner coil covered by said first insulating sheath and does not comprise said outer coil covered by said second insulating sheath, wherein said first prong has a length within a range of 50 mm to 120 mm, further wherein a first anchoring element and a first electrode are attached to said first prong and are positioned proximate said distal end of said first prong, said first anchoring element configured to permit the ingrowth of biological tissues; 
 said second prong comprises said outer coil covered by said second insulating sheath and does not comprises said inner coil covered by said first insulating sheath, wherein said second prong has a length within a range of 50 mm to 120 mm, further wherein a second anchoring element and a second electrode are attached to said second prong and positioned proximate said distal end of said second prong, said second anchoring element configured to permit the ingrowth of biological tissues; and, 
   a length of suturing material having a first end and a second end, wherein said first end of said length of suturing material is attached to said distal end of said first prong and said second end of said length of suturing material is attached to said distal end of said second prong, joining said first and second prongs, said length of suturing material forming a loop.   
     
     
         18 . The implantable electrical lead of  claim 17 , wherein said length of suturing material is in a range of 10 to 150 mm. 
     
     
         19 . The implantable electrical lead of  claim 17 , wherein a distal end of said outer coil is positioned at said distal end of said central portion, said lead further comprising an additional electrically conductive coil having a proximal end and a distal end and comprising said second prong, wherein said proximal end of said additional coil is attached to said distal end of said outer coil and said distal end of said additional coil is attached to said second end of said length of suturing material, further wherein said second anchoring element and said second electrode are attached to and positioned proximate said distal end of said additional coil and said second insulating sheath extends over said additional coil. 
     
     
         20 . A method of implanting an electrical stimulation lead having a connector, a first branch with a first electrode and first anchoring element and a second branch with a second electrode and second anchoring element, into a patient, said method comprising the steps of:
 inserting a distal end of an endoscope into a natural orifice of said patient;   inserting a lead delivery catheter into a working channel of said endoscope, said lead delivery catheter comprising:
 a catheter body having a proximal end, a distal end, and a lumen within; 
 an inflatable balloon attached to said distal end of said catheter body; and, 
 a grasping mechanism attached to said distal end of said catheter body for grasping said lead; 
   creating an incision in the internal wall of a body cavity entered via said orifice;   advancing said distal end of said catheter through said incision into a target anatomy area, wherein said target anatomy area comprises the outer walls of the esophagus and stomach and surrounding tissues proximate the gastroesophageal junction (GEJ);   inserting a laparoscope having a proximal end, a distal end, and a lumen within into an abdomen of said patient such that said distal end is positioned proximate said target anatomy area;   placing said lead within said lumen of said laparoscope through said proximal end of said laparoscope;   pulling on said loop of said lead via said grasping mechanism on said catheter to draw said lead into said target anatomy area;   positioning the first branch and the second branch of said lead such that said first and second electrodes are positioned proximate the target anatomy;   positioning said first anchoring element and said second anchoring element proximate surrounding tissues to permit growth of said surrounding tissues into said anchoring elements to secure said branches; and,   attaching said connector of said lead to an electrical pulse generator.