Devices and methods for treatment of obesity

• US 8,360,069 B2
• Filed: 10/13/2008
• Issued: 01/29/2013
• Est. Priority Date: 04/19/2006
• Status: Active Grant

• Current Assignee: Vibrynt, Inc.
• Original Assignee: Vibrynt, Inc.
• Inventors: Kim, Steven, Makower, Joshua
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): MENDOZA, MICHAEL G
• Application Number:
  US12/250,509
• Publication Number:
  US 20090036910A1
• Time in Patent Office: 1,569 Days
• Field of Search: 606191-194, 606/198, 128/898, 600/37
• US Class Current: 128/898
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61F 5/003 inflatable

Abstract

Implantable devices, instruments, kits and methods for treatment of obesity. One or more devices can be implanted adjacent to or in contact with the stomach to occupy a space to prevent the stomach from expanding into that space as food is taken into the stomach. Alternatively, one or more devices may be implanted and expanded to displace at least a portion of the wall of the stomach to decrease the internal volume of the stomach that is available to receive food. Devices may be anchored to one or more internal structures at one or more locations without piercing through the wall of the stomach. Devices can be implanted using minimally invasive methods, such as percutaneous or laparoscopic methods. Delivery instruments are also provided. An intra-gastric sizing device is provided to facilitate implantation of an extra-gastric device in some method embodiments.

Claims

1. A method of creating a feeling of satiety comprising:

providing an expandable member comprising a bulbous superior portion that tapers to an inferior tubular portion mounted on a distal end portion of a rigid elongate member of a delivery instrument;

inserting the expandable member with the delivery instrument into the abdominal cavity of a patient;

positioning the expandable member in a sub-diaphragmatic space in proximity to a stomach without penetrating a wall of the stomach; and

expanding the expandable member to reduce an achievable maximum volume of the stomach, wherein the stomach is free to move; and

removing the delivery instrument from the patient, while leaving the expandable member in position in the abdominal cavity.

2. A method of treating obesity in a patient, said method comprising:

making a percutaneous opening to the abdominal cavity of the patient;

passing at least one tether through the percutaneous opening and into the abdominal cavity;

passing an expandable device, while in a contracted configuration, through said opening and guiding said expandable device along said at least one tether to deliver said expandable device into the abdominal cavity;

positioning the expandable device in the abdominal cavity, external of the stomach;

expanding the expandable device; and

anchoring the expandable device, relative to at least one structure in the abdominal cavity, without piercing through a wall of the stomach, wherein said anchoring comprises tethering at least two locations of the expandable device to at least one structure in the abdominal cavity using said at least one tether, said at least one tether extending between said at least two locations and fixing at least one said tether to the at least one structure at each of said at least two locations.

3. The method of claim 2, wherein said anchoring comprises anchoring the expandable device to the diaphragm of the patient to maintain contact between the diaphragm and the expandable device.

4. The method of claim 2, further comprising passing a guidewire through the percutaneous opening to deliver a distal end of the guidewire to a target area where the expandable device is to be positioned;

and

fixing the guidewire to a structure in the abdominal cavity, wherein said passing an expandable device comprises sliding the expandable device over the guidewire.

5. The method of claim 4, wherein the guidewire is guided along the curved surface of the diaphragm of the patient during said passing a guidewire.

6. The method of claim 2, further comprising anchoring an adjustment member to an internal wall of the abdominal muscles.

7. The method of claim 2, further comprising anchoring an adjustment member to an external wall of the abdominal muscles.

8. The method of claim 2, further comprising anchoring an adjustment member subdermally and external of a fat layer external of the abdominal muscles.

9. The method of claim 2, wherein said positioning the expandable device in the abdominal cavity, external of the stomach comprises positioning the expandable device between the stomach and the diaphragm of the patient.

10. A method of treating obesity in a patient, said method comprising:

making a percutaneous opening to the abdominal cavity of the patient;

passing an expandable device, while in a contracted configuration, through said opening;

positioning the expandable device in the abdominal cavity, external of the stomach;

expanding the expandable device; and

anchoring the expandable device, relative to at least one structure in the abdominal cavity, without piercing through a wall of the stomach;

wherein the device further comprises an adjustment member that is connected to the expandable member via a conduit, and wherein said anchoring the expandable device, relative to at least one structure in the abdominal cavity comprises forming an opening through the diaphragm of the patient, passing the conduit out through the diaphragm, and anchoring the expandable device to the diaphragm by anchoring the adjustment member at a location on the opposite side of the diaphragm.

11. The method of claim 10 performed minimally invasively under fluoroscopic visualization.

12. The method of claim 10 performed minimally invasively under ultrasonic visualization.

13. A method of treating obesity in a patient, said method comprising:

making a percutaneous opening to the abdominal cavity of the patient;

passing at least two guide sutures through the percutaneous opening and anchoring distal portions of the guide sutures to at least two different locations on or more internal structures in the abdominal cavity of the patient, wherein proximal ends of the sutures remain outside of the percutaneous opening;

threading an expandable device over the proximal ends of the at least two guide sutures and sliding the expandable device over the guide sutures and into position against the one or more internal structures;

expanding the expandable device; and

anchoring the expandable device, relative to the one or more internal structures, without piercing through a wall of the stomach.

14. The method of claim 13, wherein the at least two guide sutures are anchored to the diaphragm of the patient.

15. The method of claim 13, wherein said anchoring the expandable device, relative to the one or more internal structures in the abdominal cavity, comprises suturing the expandable device to the one or more internal structures, using the at least two guide sutures.