Lead Access

• US 20100087706A1
• Filed: 09/29/2009
• Published: 04/08/2010
• Est. Priority Date: 09/30/2008
• Status: Abandoned Application

• Current Assignee: IntraPace, Inc.
• Original Assignee: IntraPace, Inc.
• Inventors: Wong, Ken, Syed, Baber, Sparks, Kurt
• Application Number:
  US12/568,920
• Publication Number:
  US 20100087706A1
• Time in Patent Office: Days
• US Class Current: 600/104
• CPC Class Codes: A61B 1/00096 Optical elements
• CPC Class Codes: A61B 1/00101 the distal tip features being detachable
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

The present invention discloses various methods and systems for positioning a guide wire between a patient'"'"'s mouth and a skin site via an implant tract in a stomach. The method includes locating the desired tissue site in the stomach, such as with an endoscope or other suitable instrument. In some embodiments the desired tissue site is marked inside the stomach with a visible dye or light visible from the peritoneal cavity. An implant tract is created through the stomach wall at the desired tissue site, either from “inside-out” or “outside-in”. The implant tract may be made using a RF catheter, RF guide wire, an endoneedle, or other suitable instrument. The size of the implant tract depends on the device to be placed there, such as a stimulation lead. Diameter sizes of the tract may vary from 0.014″ to 0.250″. An access hole or access port is created at a skin site, using a Verres needle, RF catheter, RF guide wire, an endoneedle, or other suitable instrument. A guide wire is then positioned through the implant tract, access port and mouth, such that the guide wire extends between the mouth and the skin site access port via the implant tract in the stomach.

Claims

1. A method for positioning a guide wire between a patient'"'"'s mouth and a skin site via a desired tissue site in a stomach, the method comprising:

locating the desired tissue site in the stomach;

creating an implant tract at the desired tissue site;

creating an access port at the skin site; and

advancing a guide wire through the implant tract at the desired tissue site, the access port at the skin site and the mouth, wherein the guide wire extends between the mouth and the skin site via the implant tract.

2. The method of claim 1, wherein the desired tissue site is a pes anserinus (“

PES”

) site in the stomach.

3. The method of claim 1, wherein locating the desired tissue site in the stomach comprises advancing an endoscope orally into the stomach and viewing the desired tissue site with the endoscope.

4. The method of claim 1, wherein once the desired tissue site is located, the method further comprises visually marking the desired tissue site within the stomach.

5. The method of claim 1, wherein creating an implant tract at the desired tissue site comprises ablating the desired tissue site with an RF catheter from inside the stomach to outside the stomach.

6. The method of claim 1, wherein creating an implant tract at the desired tissue site comprises ablating the desired tissue site with an RF catheter from outside the stomach to inside the stomach.

7. The method of claim 1, wherein creating an implant tract at the desired tissue site comprises puncturing the desired tissue site with an endoneedle.

8. The method of claim 1, wherein creating an access port at the skin site comprises puncturing the skin site with the Verres needle.

9. The method of claim 1, wherein creating an access port at the skin site comprises a percutaneous endoscopic gastrostomy (PEG) port.

10. The method of claim 1, wherein creating an access port at the skin site comprises ablating the skin site using an RF catheter.

11. A method for placing a guide wire from a desired tissue site in a patient'"'"'s stomach to a skin site, the method comprising:

visually marking the desired tissue site within the stomach;

accessing a peritoneal cavity through an access port at the skin site with a percutaneous scope with RF catheter;

advancing the percutaneous scope with RF catheter to the marked desired tissue site;

creating an implant tract at the desired tissue site from the peritoneal cavity into the stomach with the RF catheter; and

advancing a distal end of the guide wire through the percutaneous scope with RF catheter and into the stomach through the implant tract.

12. The method of claim 11, further comprising:

grabbing the distal end of the guide wire; and

extracting the distal end of the guide wire from the stomach through a mouth of the patient, wherein the guide wire extends between the mouth and the skin site via the implant tract.

13. The method of claim 11, wherein the desired tissue site is a pes anserinus (“

PES”

) site in the stomach.

14. The method of claim 11, further comprising locating the desired tissue site from within the stomach by advancing an endoscope orally into the stomach and viewing the desired tissue site with the endoscope.

15. The method of claim 11, wherein visually marking the desired tissue site comprises a dye visible from the peritoneal cavity.

16. The method of claim 11, wherein visually marking the desired tissue site comprises a light visible from the peritoneal cavity.

17. The method of claim 11, further comprising insufflating the peritoneal cavity while advancing the catheter to the desired tissue site.

18. A method for positioning a guide wire between a patient'"'"'s mouth and a skin site via a desired tissue site in a stomach, the method comprising:

creating an implant tract at the desired tissue site;

advancing a balloon catheter orally into the stomach and through the implant tract;

inflating a balloon on the balloon catheter within the peritoneal cavity creating a balloon flag;

accessing the peritoneal cavity through an access port at the skin site;

grasping the balloon flag within the peritoneal cavity with an ENT scope;

extracting the balloon flag and catheter to the access port; and

advancing guide wire through the balloon catheter and out the access port at the skin site, wherein the guide wire extends between the mouth and the skin site via the implant tract.

19. The method of claim 18, wherein the desired tissue site is a pes anserinus (“

PES”

) site in the stomach.

20. The method of claim 18, further comprising locating the desired tissue site from within the stomach by advancing an endoscope orally into the stomach and viewing the desired tissue site with the endoscope.

21. The method of claim 18, further comprising creating an access port at the skin site by puncturing the skin site with the Verres needle.

22. The method of claim 18, wherein creating an implant tract at the desired tissue site comprises advancing a guide wire across the desired tissue site using an endoscopic needle.

23. A method for positioning a guide wire between a patient'"'"'s mouth and a skin site via a desired tissue site in a stomach, the method comprising:

creating a working port into the stomach from an access port at the skin site;

advancing proximal ends of first and second guide wires through the access port and working port into the stomach and out of the patient'"'"'s mouth;

advancing an RF catheter into the stomach and through the working port into the peritoneal cavity;

withdrawing the distal end of the second guide wire into the catheter;

advancing the RF catheter to the desired tissue site;

creating an implant tract at the desired tissue site with the RF catheter;

advancing the distal end of the second guide wire into the stomach and out of the mouth of the patient;

withdrawing the catheter out of the mouth;

securing the proximal ends of the first and second guide wires together; and

pulling a distal end of the first guide wire from the access port, thereby extracting the secured proximal ends of the first and second guide wires through the working port and out of the access port, wherein the second guide wire extends between the mouth and the skin site via the implant tract.

24. The method of claim 23, wherein the desired tissue site is a pes anserinus (“

PES”

) site in the stomach.

25. The method of claim 23, further comprising sealing the working port.

26. The method of claim 23, wherein the access port and working port are made using a percutaneous endoscopic gastrostomy (PEG) procedure.

27. A method for positioning a guide wire between a patient'"'"'s mouth and a skin site via a desired tissue site in a stomach, the method comprising:

creating an implant tract at the desired tissue site from the stomach into a peritoneal cavity;

advancing a balloon catheter orally into the stomach, through the implant tract;

inflating a balloon on the balloon catheter within the peritoneal cavity creating a balloon flag;

creating a working port from the stomach to peritoneal cavity;

advancing an endoscope orally into the stomach, through the working port into the peritoneal cavity;

grabbing the balloon flag with an endoscopic grabber;

creating an access port at the skin site;

dragging the balloon flag and catheter to the access port; and

feeding a guide wire through the catheter and the access port; and

withdrawing the catheter and the endoscope;

wherein the guide wire extends between the mouth and the skin site via the implant tract.

28. The method of claim 27, wherein the desired tissue site is a pes anserinus (“

PES”

) site in the stomach.

29. The method of claim 27, further comprising sealing the working port.

30. A method for positioning a guide wire between a patient'"'"'s mouth and a skin site via a desired tissue site in a stomach, the method comprising:

creating an implant tract at the desired tissue site into a peritoneal cavity;

advancing an endoscope with an RF catheter orally into the stomach and through the implant tract;

navigating the endoscope through the peritoneal cavity;

creating an access port at the skin site using the RF catheter; and

advancing a guide wire through the endoscope and the access port, wherein the guide wire extends between the mouth and the skin site via the implant tract.

31. The method of claim 30, wherein the desired tissue site is a pes anserinus (“

PES”

) site in the stomach.

32. The method of claim 30, further comprising withdrawing the endoscope and RF catheter

33. A system for positioning a guide wire between a patient'"'"'s mouth and a skin site via a desired tissue site in a patient'"'"'s stomach comprising:

a marking device for marking the desired tissue site within the stomach;

a percutaneous scope with RF catheter configured to access a peritoneal cavity through an access port at the skin site, advance to the marked site, and create an implant tract into the stomach at the marked site;

a guide wire advanceable through the percutaneous scope with RF catheter into the stomach; and

an endoscope configured to retrieve the guide wire from the stomach, wherein the guide wire extends between the mouth and the skin site via the implant tract.

34. The system of claim 33, wherein the desired tissue site is a pes anserinus (“

PES”

) site in the stomach.

35. The system of claim 33, wherein the marking device comprises a dye visible from the peritoneal cavity.

36. The system of claim 33, wherein the marking device comprises a light visible from the peritoneal cavity.

37. A system for positioning a guide wire between a patient'"'"'s mouth and a skin site via a desired tissue site in a stomach, the method comprising:

an endoscopic needle for creating an implant tract at the desired tissue site;

a balloon catheter configured to orally advance into the stomach and through the implant tract;

an inflation device configured to inflate a balloon on the balloon catheter within the peritoneal cavity creating a balloon flag;

an ENT scope configured to access the peritoneal cavity through an access port at the skin site, grasp the balloon flag within the peritoneal cavity and extract the balloon flag and catheter to the access port; and

a guide wire advanceable through the balloon catheter and out the access port at the skin site, wherein the guide wire extends between the mouth and the skin site via the implant tract.

38. The system of claim 37, wherein the desired tissue site is a pes anserinus (“

PES”

) site in the stomach.

39. The system of claim 37, further comprising an endoscope for locating the desired tissue site from within the stomach.

40. The system of claim 37, further comprising a Verres needle for creating an access port at the skin site.

41. A system for positioning a guide wire between a patient'"'"'s mouth and a skin site via a desired tissue site in a stomach, the method comprising:

an endoscopic needle for creating an implant tract at the desired tissue site;

an endoscope with an RF catheter configured to orally advance into the stomach and through the implant tract, navigate through the peritoneal cavity and create an access port at the skin site using the RF catheter; and

guide wire advanceable through the endoscope and the access port, wherein the guide wire extends between the mouth and the skin site via the implant tract.

42. The system of claim 41, wherein the desired tissue site is a pes anserinus (“

PES”

) site in the stomach.

43. The system of claim 41, further comprising an endoscope for locating the desired tissue site from within the stomach.

44. A viewing lens for use with an endoscope or laparoscope comprising;

a body having a proximal end and a distal end;

an attachment portion coupled to the proximal end configured to sealingly attach to the distal end of an endoscope or a laparoscope; and

a clear lens portion coupled to the distal end;

wherein a distance between the clear lens and attachment portion is compatible with a focal length of the endoscope or laparoscope to allow tissue viewed in the clear lens to be in focus.

45. The lens of claim 44, further comprising a port configured to communicate directly with an endoscope or laparoscope channel.

46. The lens of claim 44, wherein the lens is made of a plastic, glass, or combination of the two materials.

47. The lens of claim 44, wherein the lens comprises a spherical tip to prevent trauma to surrounding organs during use.

48. The lens of claim 44, wherein a portion of the viewing lens and/or sides are opaque to enhance visibility within the peritoneal cavity.

49. The lens of claim 44, wherein the body has outward tapered sides along its length from the attachment portion to the lens.

50. The lens of claim 44, wherein the body may be made of pliable optically clear materials such as polyurethane or silicone.

51. The lens of claim 44, wherein the body includes an inflatable portion configured to displace organs within the peritoneal cavity for the purpose of creating space within the peritoneal cavity with limited insufflation.

52. A method for positioning a guide wire between a patient'"'"'s mouth and a skin site via a desired tissue site in a stomach, the method comprising:

creating a working port into the stomach from an access port at the skin site;

advancing an end of a guide wire through the access port and working port into the stomach;

creating an implant tract at the desired tissue site;

advancing a handleless forceps into the stomach and through the implant tract into the peritoneal cavity;

grasping the guide wire within the stomach with an endoscopic grasper and pushing the guide wire back in to the peritoneum through the working port;

steering the endoscopic grasper and guide wire toward the forceps;

grabbing the guide wire with the forceps;

withdrawing the handleless forceps and guide wire from the mouth;

wherein the guide wire extends between the mouth and the skin site via the implant tract.

53. The method of claim 52, wherein the desired tissue site is a pes anserinus (“

PES”

) site in the stomach.

54. The method of claim 52, further comprising sealing the working port.

55. The method of claim 52, wherein the access port and working port are made using a percutaneous endoscopic gastrostomy (PEG) procedure.