Endoscopic lead implantation method

• US 9,037,245 B2
• Filed: 09/02/2012
• Issued: 05/19/2015
• Est. Priority Date: 09/02/2011
• Status: Active Grant

• Current Assignee: Paras Holdings LLC
• Original Assignee: EndoStim, Inc.
• Inventors: Sharma, Virender K., Policker, Shai, Goode, Paul V., Hogg, Bevil
• Primary Examiner(s): Le, Long V
• Assistant Examiner(s): Negarestan, Farshad
• Application Number:
  US13/602,184
• Publication Number:
  US 20130090551A1
• Time in Patent Office: 989 Days
• Field of Search: 607/124, 607/133
• US Class Current: 607/40
• CPC Class Codes: A61B 1/00087 Tools A61B17/00234 takes precedence
• CPC Class Codes: A61B 1/2733 Oesophagoscopes
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/064 using markers A61B5/062 takes precedence
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 7/00 Instruments for auscultation
• CPC Class Codes: A61B 8/00 Diagnosis using ultrasonic, sonic or infrasonic waves imaging of objects using sonar G01S15/00
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61N 1/0509 Stomach and intestinal electrodes
• CPC Class Codes: A61N 1/0517 Esophageal electrodes

Abstract

A method of implanting electrically conductive leads in the gastrointestinal musculature for stimulation of target tissues involves an endoscopic approach through the esophagus. An endoscope is inserted into the esophagus of a patient. The mucosal surface of the anterior esophagus is punctured in the region encompassing the lower esophageal sphincter (LES). A tunnel is created through the submucosa and exits at the muscularis propria, adventitia, or serosal side of the stomach. The lead is navigated further to the anterior abdominal wall. A first end of the lead remains within the gastrointestinal musculature while a second end of the lead is positioned just outside the anterior abdominal wall. The first end of the lead comprises at least one electrode. An implantable pulse generator (IPG) is implanted and operably connected to the second end of the lead to provide electrical stimulation to target tissues.

Claims

1. A method of implanting electrically conductive leads in gastrointestinal musculature of a patient utilizing an endoscopic approach, comprising the steps of:

inserting an endoscope into an esophagus of a patient;

identifying a lower esophageal sphincter (LES);

entering a gastrointestinal (GI) wall with an electrically conductive lead from a mucosal side by puncturing a mucosa of an anterior segment of a region encompassing the LES;

creating a tunnel in a submucosa of the anterior segment of the region encompassing the LES, the tunnel exiting the GI wall through a muscularis propria, adventitia, or serosal side of a stomach of the patient;

navigating the lead through the tunnel to an anterior abdominal wall; and

exiting a second end of the lead through the anterior abdominal wall while leaving a first end of the lead in the gastrointestinal musculature of the patient within the tunnel, wherein the region encompassing the LES comprises an area 3 cm above and 3 cm below the LES.

2. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 1, wherein said tunnel created in the submucosa of the anterior segment of the LES is less than 5 cm in length.

3. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 1, wherein said tunnel created in the submucosa of the anterior segment of the LES is within the range of 1 cm to 5 cm in length.

4. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 1, wherein said first end of said lead is not anchored to a gastrointestinal tissue.

5. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 1, wherein said first end of said lead is anchored to a gastrointestinal tissue.

6. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 1, wherein said leads are adapted to electrically stimulate the gastrointestinal musculature in an amount effective to treat any one or combination of obesity and gastroesophageal reflux disease (GERD).

7. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 1, further comprising using magnetic, ultrasound, radiologic, or fluoroscopic imaging, or physical indicators, mechanical indicators, or auditory indicators, in addition to visual imaging to assist in lead navigation.

8. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 1, further comprising subcutaneously implanting an implantable pulse generator (IPG) proximate the lead exit point in the anterior abdominal wall.

9. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 8, further comprising attaching said second end of said lead with said IPG so that said lead can receive pulse signals from said IPG.

10. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 8, further comprising using wireless communication to transmit pulse signals from said IPG to said lead.

11. A method of implanting electrically conductive leads in the gastrointestinal musculature of a patient utilizing an endoscopic approach, comprising the steps of:

inserting an endoscope into an esophagus of a patient;

identifying a lower esophageal sphincter (LES);

entering a gastrointestinal (GI) wall with an electrically conductive lead from a mucosal side by puncturing a mucosa of an anterior segment of a region encompassing the LES;

creating a tunnel in a submucosa of the anterior segment of the region encompassing the LES, the tunnel exiting the GI wall through a serosal side of a stomach of the patient;

navigating the lead through the tunnel to an anterior abdominal wall; and

exiting a second end of the lead through the anterior abdominal wall while leaving a first end of the lead in the gastrointestinal musculature within the tunnel, wherein the region encompassing the LES comprises an area 3 cm above and 3 cm below the LES.

12. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 11, wherein the tunnel created in the submucosa of the anterior segment of the LES is equal to or greater than 5 cm in length.

13. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 11, wherein said first end of said lead is not anchored to a gastrointestinal tissue.

14. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 11, wherein said first end of said lead is anchored to a gastrointestinal tissue.

15. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 11, further comprising a step of insufflating the stomach.

16. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 11, further comprising the steps of:

finding a site where the stomach is in cross-approximation with the anterior abdominal wall;

securing the stomach with one or more anchors;

exiting the serosal surface of the stomach proximate said site; and

entering an anterior abdominal wall proximate said site.

17. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 11, wherein said leads are adapted to electrically stimulate the gastrointestinal musculature in a therapeutically effective amount to treat any one or combination of obesity and gastroesophageal reflux disease (GERD).

18. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 11, further comprising using magnetic, ultrasound, radiologic, or fluoroscopic imaging, or physical indicators, mechanical indicators, or auditory indicators, in addition to visual imaging to assist in lead navigation.

19. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 11, further comprising subcutaneously implanting an implantable pulse generator (IPG) proximate the lead exit point in the anterior abdominal wall.

20. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 19, further comprising attaching said second end of said lead with said IPG so that said lead can receive pulse signals from said IPG.

21. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 19, further comprising using wireless communication to transmit pulse signals from said IPG to said lead.

22. A method of implanting electrically conductive leads in the gastrointestinal musculature of a patient utilizing an endoscopic approach, comprising:

inserting an endoscope into an esophagus of a patient;

advancing said endoscope to an implantation site along a gastrointestinal tract of said patient;

entering a gastrointestinal (GI) wall with an electrically conductive lead from a mucosal side by puncturing a mucosa of an anterior segment of said implantation site;

creating a tunnel in a submucosa of the anterior segment of said implantation site, the tunnel exiting the GI wall through a muscularis propria, adventitia, or serosal side of a stomach of the patient;

navigating a second end of said lead, exiting the GI wall through the tunnel, to a predetermined endpoint within an abdomen of said patient; and

leaving a first end of said lead in the gastrointestinal musculature at said implantation site within the tunnel.

23. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 22, wherein said first end of said lead is not anchored to a gastrointestinal tissue.

24. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 22, wherein said first end of said lead is anchored to a gastrointestinal tissue.

25. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 22, wherein said predetermined endpoint is within a peritoneal cavity of said patient.

26. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 22, further comprising the step of navigating said second end of said lead through an anterior abdominal wall of said patient and wherein said predetermined endpoint is within a subcutaneous region of the abdomen.

27. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 22, further comprising using magnetic, ultrasound, radiologic, or fluoroscopic imaging, or physical indicators, mechanical indicators, or auditory indicators, in addition to visual imaging to assist in lead navigation.

28. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 22, wherein the leads are adapted to electrically stimulate the gastrointestinal musculature in a therapeutically effective amount to treat a condition of a gastrointestinal system of said patient.

29. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 28, wherein said condition includes obesity and gastroesophageal reflux disease (GERD).

30. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 22, further comprising implanting an implantable pulse generator (IPG) proximate said predetermined endpoint.

31. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 30, further comprising attaching said second end of said lead with said IPG such that said lead can receive pulse signals from said IPG.

32. The method of implanting electrically conductive leads in the gastrointestinal musculature utilizing an endoscopic approach of claim 30, further comprising using wireless communication to transmit pulse signals from said IPG to said lead.