Method and device for securing a functional device to a stomach

• US 7,120,498 B2
• Filed: 10/23/2003
• Issued: 10/10/2006
• Est. Priority Date: 05/01/2001
• Status: Expired due to Fees

• Current Assignee: IntraPace, Inc.
• Original Assignee: IntraPace, Inc.
• Inventors: Layman, Ted W., Lake, Sharon L., Colliou, Olivier K., Imran, Mir A., Gandhi, Deepak R.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US10/691,880
• Publication Number:
  US 20040088023A1
• Time in Patent Office: 1,083 Days
• Field of Search: 607/40, 607/116, 607/133, 607/72, 607/73, 607/138, 607/143, 600/29, 600/30, 600/3, 604/891.1
• US Class Current: 607/40
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 5/4238 stomach
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61F 5/0003 Apparatus for the treatment of obesity; Anti-eating devices surgical instruments or methods for treatment of obesity, devices specially adapted therefor A61B17/00; hollow or tubular parts of organs A61F2/04
• CPC Class Codes: A61M 2025/0233 specifically adapted for attaching to a body wall by means which are on both sides of the wall, e.g. for attaching to an abdominal wall
• CPC Class Codes: A61M 2025/028 having a mainly rigid support structure
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61N 1/0509 Stomach and intestinal electrodes
• CPC Class Codes: A61N 1/0517 Esophageal electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: G01N 27/126 comprising organic polymers

Abstract

A device, system and method for diagnosing and treating gastric disorders is provided. A functional device resides within the patient'"'"'s stomach and is secured to the stomach wall by an attachment device. The functional device may be a sensor for sensing various parameters of the stomach or stomach environment, or may be a therapeutic delivery device. The functional device in one embodiment provides a device, system and method for gastric electrical stimulation where stimulating electrodes are secured to the wall of the stomach by the attachment device or otherwise. A preferred device includes: at least one stimulating electrode in electrical contact with the stomach wall; an electronics unit containing the electronic circuitry of the device; and an attachment mechanism for attaching the device to the stomach wall. The functional devices may be programmed to respond to sensed information or signals. An endoscopic delivery system delivers the functional device through the esophagus and into the stomach where it is attached the stomach wall. The endoscopic instruments attach or remove the attachment devices and functional devices from the stomach and may be used to assist in determining the optimal attachment location.

Claims

1. An anchor for attaching to a stomach wall of a stomach, the anchor comprising:

a functional portion configured to perform a therapeutic or diagnostic function at the stomach; and

a securing portion operative to extend from within the stomach into the stomach wall in a direction substantially perpendicular to a plane of smooth stomach muscle contractions to thereby secure the attachment device to the stomach wall, wherein said functional portion comprises a therapeutic agent delivery device.

2. An anchor for attaching to a stomach wall of a stomach, the anchor comprising:

a functional portion configured to perform a therapeutic or diagnostic function at the stomach; and

a securing portion operative to extend from within the stomach into the stomach wall in a direction substantially perpendicular to a plane of smooth stomach muscle contractions to thereby secure the attachment device to the stomach wall, wherein said securing portion includes an electrode located thereon.

3. An anchor for attaching to a stomach wall of a stomach, the anchor comprising:

a functional portion configured to perform a therapeutic or diagnostic function at the stomach;

a securing portion operative to extend from within the stomach into the stomach wall in a direction substantially perpendicular to a plane of smooth stomach muscle contractions to thereby secure the attachment device to the stomach wall; and

an electronic circuit configured to provide electrically stimulating pulses to a stomach wall through said electrode.

4. An anchor for attaching to a stomach wall of a stomach, the anchor comprising:

a functional portion configured to perform a therapeutic diagnostic function at the stomach; and

a securing portion having a proximal portion and a distal portion having an expandable portion wherein the securing portion is operative to extend from within the stomach into the stomach wall with the proximal portion remaining in the stomach and the distal portion extending at least in part through the stomach wall with the expandable portion expanded to thereby secure the anchor to the stomach wall.

5. The anchor of claim 4 wherein said expandable distal portion comprises at least one laterally extending member.

6. The anchor of claim 5 wherein said at least one laterally extending member is configured to secure the anchor to the stomach wall.

7. The anchor of claim 5 wherein said at least one laterally extending member comprises an electrode located thereon.

8. The anchor of claim 7 further comprising:

an inflation lumen in fluid communication with said inflatable member and an inflation medium for inflating said inflatable member.

9. The anchor of claim 5 wherein said expandable distal portion comprises an inflatable member.

10. The anchor of claim 9 wherein said inflation medium comprises a curable polymer.

11. The anchor of claim 4 wherein said expandable distal portion comprises a spring mechanism biased in an expanded position.

12. The anchor of claim 4 wherein said expandable member is arranged to expand adjacent an outer surface of the stomach wall.

13. The anchor of claim 4 wherein said securing portion further comprises a bumper arranged to engage said attachment device so that said bumper abuts the inner surface of the stomach wall.

14. A method of attaching a stimulating electrode to a stomach wall comprising the steps of:

providing an anchor including a securing portion;

advancing the anchor through the esophagus and towards an attachment site within the stomach, and attaching the anchor to the attachment site;

providing an electrically stimulating electrode;

advancing the electrically stimulating electrode through the esophagus and towards a stimulating site within the stomach;

positioning the electrically stimulating electrode in electrical contact with the stomach wall.

15. The method of claim 14 wherein the step of attaching the electrically stimulating electrode to the stimulating site comprises:

attaching the electrically stimulating electrode to the stimulating site so that the electrode is coupled to the anchor.