GASTRIC RETAINING DEVICES AND METHODS

• US 20090187201A1
• Filed: 01/09/2009
• Published: 07/23/2009
• Est. Priority Date: 07/28/2003
• Status: Active Grant

• Current Assignee: BAROnova, Inc.
• Original Assignee: BAROnova, Inc.
• Inventors: HALL, Gregory W., BURNETT, Daniel Rogers
• Granted Patent: US 9,510,834 B2
• Time in Patent Office: Days
• US Class Current: 606/153
• 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 outer shell member which is reconfigurable from a low-profile delivery configuration to an extended deployment configuration, where the delivery configuration is sized for per-oral passage into a stomach of a patient and the deployment configuration is sized to prevent or inhibit passage through a pylorus of the stomach; and

a core member which is positionable relative to the outer shell member such that the shell member in its deployment configuration at least partially surrounds the core member while remaining open to an environment of the stomach.

2. The apparatus of claim 1 wherein the deployment configuration is sized to intermittently obstruct the pylorus.

3. The apparatus of claim 1 wherein the outer shell member is reconfigurable from the low-profile to extended configuration via inverting relative to the core member.

4. The apparatus of claim 1 wherein the outer shell member comprises a support portion distal to a contact portion.

5. The apparatus of claim 4 wherein the support portion is relatively more rigid than the contact portion such that a cross-sectional diameter of the outer shell member is maintained in the deployment configuration.

6. The apparatus of claim 4 wherein the contact portion is comprised of a compliant material for atraumatic presentation against the stomach.

7. The apparatus of claim 1 further comprising a delivery tube defining a lumen therethrough within which the apparatus is positioned when in its low-profile delivery configuration.

8. The apparatus of claim 7 wherein the outer shell member is deployed into its extended deployment configuration when urged against a distal end of the delivery tube within the stomach.

9. The apparatus of claim 1 wherein the component comprises a shape memory material.

10. The apparatus of claim 1 wherein the component comprises a spring-loaded material.

11. A method for facilitating gastric retention, comprising:

advancing a distal end of a delivery tube per-orally into a stomach of a patient;

urging an apparatus having an outer shell member configured in a low-profile delivery configuration from a lumen of the delivery tube such that the apparatus is ejected at least partially into the stomach;

reconfiguring the outer shell member into an extended deployment configuration such that the outer shell member at least partially surrounds a core member while remaining open to an environment of the stomach; and

,

maintaining the extended deployment configuration such that the apparatus is prevented or inhibited from passage through a pylorus of the stomach while intermittently obstructing the pylorus.

12. The method of claim 11 wherein advancing comprises passing the delivery tube trans-esophageally into the stomach.

13. The method of claim 11 wherein urging comprises pushing the apparatus via an actuator through the lumen.

14. The method of claim 11 wherein reconfiguring comprises urging the outer shell member proximally against the distal end of the delivery tube such that the shell member inverts into its extended deployment configuration.

15. The method of claim 11 wherein reconfiguring comprises allowing the outer shell member to self-invert from its low-profile to its extended deployment configuration.

16. The method of claim 11 wherein reconfiguring comprises ejecting the apparatus via an everting mechanism.

17. The method of claim 11 wherein maintaining comprises inhibiting the apparatus from reconfiguring from its deployment configuration to its delivery configuration.

18. The method of claim 11 further comprising contacting tissue surrounding the pylorus via a compliant contact portion of the outer shell member.

19. The method of claim 18 further comprising maintaining a shape of a support portion of the outer shell member which is proximal to the contact portion such that passage through the pylorus is prevented or inhibited thereby.

20. The method of claim 11 further comprising anchoring the apparatus via a positioning member projecting from the apparatus and extending at least partially through the pylorus.