Gastric retaining devices and methods

• US 9,924,948 B2
• Filed: 05/01/2009
• Issued: 03/27/2018
• Est. Priority Date: 07/28/2003
• Status: Expired due to Fees

• Current Assignee: BAROnova, Inc.
• Original Assignee: BAROnova, Inc.
• Inventors: Burnett, Daniel R., Hall, Gregory W.
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US12/434,594
• Publication Number:
  US 20090216262A1
• Time in Patent Office: 3,252 Days
• Field of Search: 606 19-195, 606213, 606215, 60410306, 60410308, 60410101, 604 9601, 60410307, 604104
• 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
• 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 intragastric weight-loss system, comprising:

a double-balloon gastric retention device, comprising;

a proximal inflatable balloon having a rounded shape when in an inflated configuration, wherein the proximal inflatable balloon comprises a singular catheter connection along a surface of the proximal inflatable balloon,

a distal inflatable balloon having a rounded shape when in an inflated configuration, wherein the proximal and distal inflatable balloons have an equally sized shape and diameters when in the inflated configuration,

an elongate bridging member extending through and between the proximal inflatable balloon and the distal inflatable balloon such that the balloons are attached to respective proximal and distal portions of the bridging member and extend radially from the bridging member when inflated, wherein the bridging member maintains the balloons in proximity relative to one another, and

at least one inflation lumen which extends through the bridging member such that the inflation lumen is in fluid communication with the singular catheter connection;

a delivery tube comprising a catheter or endoscope having a flexible length which is sized for advancement through an esophagus and which is releasably coupled to the singular catheter connection of the proximal inflatable balloon to deliver the double-balloon gastric retention device to a stomach of a patient and inflate the proximal inflatable balloon and the distal inflatable balloon, wherein the proximal inflatable balloon and the distal inflatable balloon are configured to freely move within the stomach when inflated, wherein the proximal inflatable balloon and the distal inflatable balloon are configured to be inflated through the singular catheter connection when the double-balloon gastric retention device is within the stomach; and

an elongate instrument having a distal end adapted to contact the proximal inflatable balloon and deflate the double-balloon gastric retention device by applying a suction force through the elongate instrument, and

wherein at least one of the inflatable balloons is configured to be seated within a gastric space and occupy a volume thereof and is further sized to inhibit passage of the double-balloon gastric retention device through the pylorus.

2. The system of claim 1, wherein the proximal inflatable balloon is comprised of a first material which is different from a second material comprising the distal inflatable balloon.

3. The system of claim 1, wherein the elongate bridging member defines at least one fluid lumen therethrough.

4. The system of claim 1, wherein the singular catheter connection is configured to receive a fluid to inflate at least one of the inflatable balloons.

5. The system of claim 4, wherein the fluid is saline.

6. The system of claim 1, wherein the singular catheter connection is self-sealing.

7. The system of claim 1, wherein the double-balloon gastric retention device is configured to inhibit passage of food through the pylorus when the food is in the stomach.

8. The system of claim 1, wherein the delivery tube is configured to be released from the double-balloon gastric retention device when the proximal inflatable balloon and the distal inflatable balloon are inflated in the stomach of the patient.

9. The system of claim 1, wherein the proximal inflatable balloon comprises a ring placed around the singular catheter connection, wherein the ring is configured to facilitate attachment to the delivery tube.