Gastric retaining devices and methods

• US 9,687,243 B2
• Filed: 01/09/2009
• Issued: 06/27/2017
• Est. Priority Date: 07/28/2003
• Status: Active Grant

• Current Assignee: BAROnova, Inc.
• Original Assignee: BAROnova, Inc.
• Inventors: Hall, Gregory W., Burnett, Daniel Rogers
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US12/351,644
• Publication Number:
  US 20090187200A1
• Time in Patent Office: 3,091 Days
• Field of Search: 128830, 128831, 606127, 606151, 606153, 606191, 606192, 606198, 606200, 606213, 606193, 606194, 606195, 604516, 604104-106, 60410306, 60410308, 60410101
• 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 17/12099 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 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/1205 Introduction devices
• 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 gastric retention of a variety of therapeutic devices. devices generally include a support portion for preventing the device from passing through the pyloric valve or esophagus wherein 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 apparatus for facilitating gastric retention, comprising:

an elongate delivery instrument defining a lumen therethrough;

an obstructing member having a flexible covering which is separable from a portion of the obstructing member and where the obstructing member is reconfigurable from a low-profile delivery configuration to an enlarged deployment configuration;

an actuating member translatable through the delivery instrument for actuating the obstructing member from the delivery configuration to the deployment configuration, wherein the actuating member comprises an elongate instrument releasably attached to the obstructing member;

a positioning member coupled to and extending from the obstructing member and having a shape adapted to pass at least partially through a pylorus to position the apparatus relative to the pylorus; and

a retaining member coupled to a distal end of the positioning member for maintaining the apparatus in intermittent contact with the pylorus, where the retaining member has an atraumatic shape which maintains its configuration prior to and after deployment and further defines a diameter greater than a diameter of the positioning member when in the deployment configuration,

wherein the obstructing member defines an elongated shape when in the delivery configuration and translated in a longitudinal direction through the delivery instrument for trans-esophageal advancement into a stomach,

wherein the obstructing member, the positioning member which is coupled to the obstructing member, and the retaining member which is coupled to the distal end of the positioning member are releasably detachable from the delivery instrument,

wherein the obstructing member is expanded in the deployment configuration to prevent or inhibit passage through a pylorus of the stomach, and

wherein the flexible covering comprises a tissue contact surface and wherein the tissue contact surface is inverted relative to the positioning member when the obstructing member is reconfigured from the low-profile delivery configuration to the enlarged deployment configuration.

2. The apparatus of claim 1 wherein the elongate delivery instrument is sized for trans-esophageal advancement.

3. The apparatus of claim 1 further comprising an endoscopic instrument within the elongate delivery instrument.

4. The apparatus of claim 1 wherein the obstructing member is comprised of a shape-memory material.

5. The apparatus of claim 1 wherein the obstructing member defines an open structure in the deployment configuration.

6. The apparatus of claim 1 wherein the elongated delivery configuration is maintained by a constraining force applied upon the obstructing member.

7. The apparatus of claim 6 wherein the constraining force comprises a longitudinal extension force.

8. The apparatus of claim 1 wherein the deployment configuration forms a lattice structure.

9. The apparatus of claim 1 wherein the obstructing member maintains its shape when in the deployment configuration such that the pylorus is intermittently obstructed by the obstructing member.

10. The apparatus of claim 1 wherein the tissue contact surface radially surrounds the positioning member when the obstructing member is in the low-profile delivery configuration.

11. The apparatus of claim 1 wherein the flexible covering is attached to at least one portion of the obstructing member and separated from other portions of the obstructing member when the obstructing member is in both the low-profile delivery configuration and the enlarged deployment configuration.

12. The apparatus of claim 1 wherein the obstructing member is reconfigured into the enlarged deployment configuration when the flexible covering is urged against a distal end of the elongate delivery instrument.

13. The apparatus of claim 1 wherein a longitudinal length of the flexible covering is elongated when the obstructing member defines the elongated shape.