Positioning tools and methods for implanting medical devices

• US 7,892,292 B2
• Filed: 06/30/2006
• Issued: 02/22/2011
• Est. Priority Date: 08/27/2001
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Synecor LLC
• Inventors: Glenn, Richard A., Balbierz, Dan, Lunsford, John, Athas, William L., Stack, Richard S.
• Primary Examiner(s): Stewart; Alvin J.
• Application Number:
  US11/479,204
• Publication Number:
  US 20060287734A1
• Time in Patent Office: 1,698 Days
• Field of Search: 623/23.64, 623/23.65, 623/1.15, 623/1.24, 623/1.26, 623/23.68, 623/23.7, 606/106, 606/108, 606/139, 606/167, 606/151, 606/191, 606/195
• US Class Current: 623/23.65
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions
• CPC Class Codes: A61F 5/0089 Instruments for placement or removal

Abstract

Described herein is a positioning tool having an elongate portion for carrying a medical implant. Also described is a method of positioning a medical implant using an elongate positioning tool. One form of the method includes positioning a medical implant on a distal portion of an elongate positioning tool, inserting the positioning tool with the implant thereon into a body cavity, manipulating the positioning tool to position the implant into contact with tissue at an attachment location, attaching the implant to surrounding tissue at the attachment location, separating the implant from the positioning tool, and withdrawing the positioning tool from the body. In a preferred embodiment, the position of the implant is visually confirmed using an endoscope before the implant is attached to surrounding tissue. In one embodiment, the implant is a satiation device and the body cavity is the esophagus and/or stomach. In an alternative embodiment, an expansion structure on the distal end of the elongate portion expands and/or contracts the medical implant to facilitate positioning.

Claims

1. A method of implanting a satiation device in an upper gastro-intestinal region of a body, comprising the steps of:

positioning on a distal portion of an elongate positioning tool, a self-expanding satiation device having a plurality of anchor loops, with a plurality of mandrels in the tool being releasably attached to the anchor loops to support the satiation device on the positioning tool;

inserting the positioning tool with the satiation device thereon contained within a sheath through an oral cavity and into a portion of the upper gastro-intestinal tract;

expelling the satiation device from the sheath,

independently manipulating the mandrels of the positioning tool from each other to position the satiation device in contact with tissue at an implant location, wherein the manipulating step can be controlled manually by a user;

coupling the satiation device to surrounding tissue at the attachment location;

separating the satiation device from the positioning tool; and

withdrawing the positioning tool from the body, leaving the satiation device positioned to restrict flow of ingested food from the esophagus into the mouth.

2. The method of claim 1, further including the step of expanding the distal portion of the positioning tool to expand the satiation device.

3. The method of claim 2, wherein the expanding step is performed with the satiation device in the proximal stomach, and the manipulating step includes drawing the satiation device into contact with tissue of the gastro-esophageal junction region.

4. The method of claim 3, wherein the manipulating step includes drawing the satiation device into contact with tissue below the z-line of the gastro-esophageal junction region.

5. The method of claim 3, wherein the manipulating step includes drawing the satiation device into contact with tissue of the esophagus.

6. The method of claim 3, wherein the manipulating step includes drawing the satiation device into contact with tissue of the proximal stomach.

7. The method of claim 3, wherein the manipulating step causes a circumferential region of the satiation device to make sealing contact with tissue of the gastro-esophageal junction region.

8. The method of claim 3, wherein:

the positioning tool includes a mandrel and a plurality of rods coupled to the mandrel;

the positioning step includes positioning the satiation device on the rods; and

the expanding step includes extending a portion of at least one of the rods away from the mandrel.

9. The method of claim 8, wherein the mandrel is slidable within a cannula, wherein at least one of the rods has a first end attached to the mandrel, a second end attached to the cannula, and a pivot point between the first and second ends, and wherein the expanding step includes sliding the mandrel relative to the cannula to cause the pivot point to move in a lateral direction relative to the mandrel.

10. The method of claim 8, wherein:

the mandrel is slidable within a cannula, and the rods are disposed within the cannula when in an un-expanded position;

the expanding step includes sliding the mandrel relative to the cannula to cause the rods to extend from a distal opening in the cannula and to cause a portion of at least one of the rods to spring in a lateral direction relative to the cannula.

11. The method of claim 2, wherein:

the positioning tool includes an inflatable balloon;

the positioning step includes positioning the satiation device on the inflatable balloon; and

the expanding step includes introducing an inflation medium into the balloon.

12. The method of claim 1, wherein:

the providing step further provides a guide connected to the positioning tool and defining a first channel;

the inserting step includes positioning the guide within the esophagus; and

the method includes the steps of passing an instrument through the channel in the guide and using the instrument in performing the coupling step.

13. The method of claim 12, wherein the guide is an inflatable balloon, wherein the first channel extends through the balloon, and wherein the balloon further includes a second channel for receiving the positioning tool.

14. The method of claim 12, further including the step of rotating the guide to reposition the instrument.

15. The method of claim 1, wherein the placing step includes using a fastener to attach the satiation device to the positioning tool.

16. The method of claim 1, further including the step of, prior to the coupling step, visually inspecting the position of the satiation device using an endoscope.

17. The method of claim 1, wherein the satiation device is positioned to cause ingested food to flow from the esophagus into the stomach at a rate that is slower than a rate at which the food would flow in the absence of the satiation device.

18. The method of claim 1, wherein the satiation device defines a bi-directional flow path in the gastro-esophageal junction region.

19. The method of claim 1, wherein the providing step provides the satiation device to include a wall defining a channel.

20. The method of claim 1, wherein the satiation device is positioned to cause ingested food to flow from the esophagus into the stomach at a rate that is slower than a rate at which food would flow in the absence of the satiation device.