Intestinal sleeves and associated deployment systems and methods

• US 8,109,895 B2
• Filed: 08/31/2007
• Issued: 02/07/2012
• Est. Priority Date: 09/02/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Barosense, Inc. (Boston Scientific Scimed Incorporated)
• Inventors: Williams, Michael S., Fifer, Daniel W., Orth, Geoffrey A., Smith, Jeffrey A., Glenn, Richard A., Athas, William L., Stack, Richard S.
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): Hanrahan, Benedict L
• Application Number:
  US11/897,701
• Publication Number:
  US 20080195226A1
• Time in Patent Office: 1,621 Days
• Field of Search: 604 8- 9, 604/98.02, 604/500, 604/96.01, 604/164.01, 604233-284, 604523-525, 604540-544, 623 2365- 2367, 623/24, 623/23.64, 606/108, 606/151, 606153-154, 606/215
• US Class Current: 604/8
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0089 Instruments for placement or removal

Abstract

An intestinal implant includes a proximal anchor self-expandable from a radially compressed position to a radially expandable position for engagement with a wall of the intestinal lumen and a flexible sleeve coupled to the anchor. The sleeve is implanted with the anchor downstream from the pylorus and the sleeve extending further downstream through the intestinal lumen.

Claims

1. A method of inducing weight loss or treating Type II diabetes in a patient, comprising:

intraorally accessing the patient'"'"'s intestine with a implant system having a deployment sheath dimensioned to extend, at its distal end, to a region within the patient'"'"'s intestine, and an intestinal implant having a self-expandable anchor with a distal end and inner and outer sides, and an elongate flexible sleeve attached at one sleeve end to the anchor such that the one sleeve end wraps around the distal end of the anchor, covering the anchor'"'"'s distal end and outer side, where said anchor is releasable from the distal end of said sheath and the sleeve is disposed within the sheath in an everted condition;

anchoring the implant within the intestine by releasing the anchor from the sheath, causing the anchor to expand from a radially compressed position within the sheath to a radially expandable position outside the sheath for engagement with a wall of the intestinal lumen; and

before or after said anchoring, deploying said sleeve through the anchor and positioning the sleeve within the intestine, downstream of the anchor, wherein the sleeve'"'"'s inner surface within the sheath forms the sleeve'"'"'s outer surface outside the sheath, and the inner and outer sides of the anchor are covered by the sleeve.

2. The method according to claim 1, wherein said anchoring includes releasing the anchor from the sheath downstream of the pylorus in the intestine.

3. The method according to claim 1, wherein positioning the sleeve within the intestine, downstream of the anchor includes:

drawing a distal portion of the sleeve in a proximal direction to invert the sleeve and to form a pocket between adjacent portions of the sleeve; and

with at least a portion of the sleeve within the intestinal lumen, directing a fluid into the pocket to cause the sleeve to evert.

4. The method according to claim 3, wherein said positioning includes directing the fluid through the sheath.

5. The method according to claim 1, wherein said anchoring includes advancing an inner sheath through said deployment sheath to eject the anchor from the distal end of the deployment sheath.

6. The method according to claim 1, wherein positioning the distal end within the intestinal lumen downstream of the proximal end includes positioning a detachable element on the sleeve and causing the element to be carried in a downstream direction by peristaltic movement of the intestine.

7. The method according to claim 1, wherein positioning the distal end within the intestinal lumen downstream of the proximal end includes positioning a distal portion of the sleeve within a capsule, and directing a fluid into the intestinal lumen and into contact with the capsule, such that the capsule advanced through the intestinal lumen in response to pressure from the fluid.

8. The method according to claim 6, wherein a proximal portion of the sleeve is anchored within the intestinal lumen prior to the step of directing the fluid, and wherein advancement of the capsule releases the sleeve from the capsule.

9. The method according to claim 1, wherein the method is further for treating Type II diabetes and/or inducing weight loss, and further includes the step of causing ingested material moving into the intestine to pass into the sleeve, thereby minimizing contact between the material and tissue of the intestinal lumen and minimizing absorption of calories and/or carbohydrates.