Laparoscopic lead implantation method
First Claim
1. A method of laparoscopically implanting at least one electrically conductive electrode, as part of an electrically conductive lead, proximate the lower esophageal sphincter (LES) of a patient, said method comprising the steps of:
- inserting the distal end of a laparoscope into an abdominal cavity of a patient through an incision in an abdominal wall of said patient;
surgically exposing at least 2 cm of an anterior abdominal portion of a lower esophageal wall of said patient;
delivering said electrically conductive lead through a port on said laparoscope, wherein said lead comprises an elongate metal body having a proximal end and a distal end, said elongate body being covered in an electrically insulating material, said proximal end having a connector for connection to an implantable pulse generator and said distal end including said at least one exposed electrode and an anchoring member, said lead further comprising a first suture having a first end and a second end opposite said first end, wherein said first end is attached to said distal end of said lead body and a first needle is attached to said second end;
advancing said electrically conductive lead to a target position at an anterior surface of said exposed lower esophageal wall;
using said first needle and said first suture to pass said electrode through said LES such that said exposed electrode comes to rest within or proximate a muscular layer of a wall of said LES and said first needle and a portion of said second end of said first suture re-emerge from said wall of said LES;
applying at least one securing member to said portion of said second end of said suture at a distance at least 2-15 mm away from said wall of said LES;
removing said first needle and excess first suture; and
,fixing said anchoring member to proximate LES tissue by using a separate second needle to couple a second suture to said anchoring member.
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Accused Products
Abstract
A method of laparoscopically implanting an electrically stimulating lead proximate the lower esophageal sphincter (LES) of a patient includes delivering the lead through a port of a laparoscope inserted into the abdominal cavity of the patient through an incision in the abdominal wall. The stimulating electrode is implanted in or proximate the muscularis layer of the lower esophageal wall to treat esophageal reflux disease (GERD). The lead includes a needle and suture at its distal end for pulling the electrode into the muscular wall of the LES. Clips are applied to the suture attached to the distal end of the lead to prevent retrograde movement of the electrode. The lead also includes an anchoring member for anchoring the portion of the lead proximal to the electrode. The method and lead used with the method allow the surgeon to work within the confined anatomy present at the gastroesophageal junction and prevents backwards movement and dislodgment of the electrode. The implantation procedure can be combined with a hiatal hernia repair to repair the hernia and prevent recurrence of a hiatal hernia.
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Citations
14 Claims
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1. A method of laparoscopically implanting at least one electrically conductive electrode, as part of an electrically conductive lead, proximate the lower esophageal sphincter (LES) of a patient, said method comprising the steps of:
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inserting the distal end of a laparoscope into an abdominal cavity of a patient through an incision in an abdominal wall of said patient; surgically exposing at least 2 cm of an anterior abdominal portion of a lower esophageal wall of said patient; delivering said electrically conductive lead through a port on said laparoscope, wherein said lead comprises an elongate metal body having a proximal end and a distal end, said elongate body being covered in an electrically insulating material, said proximal end having a connector for connection to an implantable pulse generator and said distal end including said at least one exposed electrode and an anchoring member, said lead further comprising a first suture having a first end and a second end opposite said first end, wherein said first end is attached to said distal end of said lead body and a first needle is attached to said second end; advancing said electrically conductive lead to a target position at an anterior surface of said exposed lower esophageal wall; using said first needle and said first suture to pass said electrode through said LES such that said exposed electrode comes to rest within or proximate a muscular layer of a wall of said LES and said first needle and a portion of said second end of said first suture re-emerge from said wall of said LES; applying at least one securing member to said portion of said second end of said suture at a distance at least 2-15 mm away from said wall of said LES; removing said first needle and excess first suture; and
,fixing said anchoring member to proximate LES tissue by using a separate second needle to couple a second suture to said anchoring member. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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Specification