Pyloric valve obstructing devices and methods

• US 8,663,338 B2
• Filed: 01/09/2009
• Issued: 03/04/2014
• Est. Priority Date: 07/28/2003
• Status: Active Grant

• Current Assignee: BAROnova, Inc.
• Original Assignee: BAROnova, Inc.
• Inventors: Burnett, Daniel Rogers, Hall, Gregory W., Richman, Roxanne, Gallup, David A., Campbell-White, Annette
• Primary Examiner(s): McEvoy, Thomas
• Assistant Examiner(s): TANNER, JOCELIN C
• Application Number:
  US12/351,686
• Publication Number:
  US 20090118757A1
• Time in Patent Office: 1,880 Days
• Field of Search: 606/157, 606/192, 606/200, 606/194, 606213-215, 606/195, 606/193, 606/197, 600/37, 600/114, 600/115, 600/136, 604/175, 604/270, 604/43, 604/500, 604/8, 604/9, 607/40, 623/23.64, 623/23.65, 623/23.71, 623/23.72, 623/23.68, 623/23.67, 623/23.7
• US Class Current: 623/23.72
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12086 magnetically detachable
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions

Abstract

Methods, devices and systems facilitate intermittent and/or partial obstruction of a pyloric valve. Devices generally include a support portion for preventing the device from passing through the pyloric valve and a tissue engagement portion for contacting tissue adjacent the pyloric valve to obstruct the valve. Some embodiments also include a positioning member extending from the tissue engagement portion for helping position the device for obstructing the valve. A retaining member may optionally be included on the distal end of the positioning member for further maintaining a position of the device in the stomach. Some embodiments are deliverable into the stomach through the esophagus, either by swallowing or through a delivery tube or catheter. Some embodiments are fully reversible. Some embodiments self-expand within the stomach, while others are inflated or otherwise expanded.

Claims

1. An intestinal insertion device, comprising:

an elongated connecting member detachable from a delivery device and having a proximal end and a distal end, wherein the connecting member has a length which is configured to be placed within and follow a portion of an intestinal tract and where the connecting member also has a diameter which is sized to freely slide through a pyloric valve;

a proximal occlusion member coupled to the proximal end and having a first portion thereof that reconfigurable from a low-profile delivery shape to an expanded deployment shape which is sized for anchoring within the stomach, wherein the proximal occlusion member comprises a support portion proximal to a tissue contact portion which is positioned adjacent to the connecting member, the support portion being relatively stiffer than the tissue contact portion such that a shape of the support portion is maintained when in a deployed configuration;

a distal occlusion member coupled to a distal end of the connecting member and having a size which is smaller than the expanded deployment shape of the proximal occlusion member such that the distal occlusion member is non-expandable after deployment, where the distal occlusion member is sized to be slidably positionable relative to the intestinal tract, wherein the proximal occlusion member having the first portion surrounding a non-inflated or solid structure, more rigid than said first portion, which defines a hollow portion within in its deployment configuration and which is larger than the distal occlusion member; and

one or more releasable bioactive materials incorporated along the device.

2. The device of claim 1 wherein the proximal occlusion member is sized for anchoring within a stomach such that passage through a pyloric valve is inhibited or prevented.

3. The device of claim 1 further comprising a neurological stimulator positioned along the connecting member.

4. The device of claim 1 wherein the one or more releasable bioactive materials comprise one or more slow-releasing drugs.

5. The device of claim 4 wherein the one or more slow-releasing drugs are infused into a covering over the device.

6. The device of claim 4 wherein the one or more slow-releasing drugs are incorporated along the device.

7. An intestinal insertion device, comprising:

an elongated connecting member detachable from a delivery device and having a proximal end and a distal end, wherein the connecting member has a length which is configured to be placed within and follow a portion of an intestinal tract and where the connecting member also has a diameter which is sized to freely slide through a pyloric valve;

a proximal occlusion member coupled to the proximal end and having a first portion thereof that reconfigurable from a low-profile delivery shape to an expanded deployment shape which is sized for anchoring within the stomach, wherein the proximal occlusion member comprises a support portion proximal to a tissue contact portion which is positioned adjacent to the connecting member, the support portion being relatively stiffer than the tissue contact portion such that a shape of the support portion is maintained when in a deployed configuration; and

,

a distal occlusion member coupled to a distal end of the connecting member and having a size which is smaller than the expanded deployment shape of the proximal occlusion member such that the distal occlusion member is non-expandable after deployment,

where the distal occlusion member is sized to be slidably positionable relative to the intestinal tract and where the proximal occlusion member having the first portion surrounding a non-inflated or solid structure, more rigid than said first portion, which defines a hollow portion within in its deployment configuration and which is larger than the distal occlusion member.

8. The device of claim 7 wherein the proximal occlusion member is sized for anchoring within a stomach such that passage through a pyloric valve is inhibited or prevented.