Gastric device and instrument system and method

• US 7,076,305 B2
• Filed: 11/14/2002
• Issued: 07/11/2006
• Est. Priority Date: 05/01/2001
• Status: Expired due to Fees

• Current Assignee: IntraPace, Inc.
• Original Assignee: IntraPace, Inc.
• Inventors: Collion, Olivier K., Layman, Ted W., Lake, Sharon L., Imran, Mir A.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US10/295,115
• Publication Number:
  US 20030167024A1
• Time in Patent Office: 1,335 Days
• Field of Search: 607/40, 607/41, 607/133, 607/116, 607/72, 607/73, 607/138, 607/143, 600/300, 604/891.1, 606/129
• 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, resorptive for implantable prostheses A61F2210/0004
• 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. A method for treating or diagnosing a patient comprising the steps of:

providing a functional device configured to perform a therapeutic or diagnostic function at the stomach,

placing a guide from within the stomach with a portion of the guide placed from within the stomach, extending into the stomach wall at an attachment site;

coupling the functional device to the guide; and

guiding the functional device with the guide to the attachment site from within the stomach.

2. A system for attaching a functional device to a stomach wall from within a stomach wherein the functional device is configured to perform a therapeutic or diagnostic function at the stomach, the system comprising:

a guide including a first portion arranged to extend from within the stomach through the stomach wall at an attachment site to the outside of the stomach wall, wherein the first portion of the guide comprises an anchor configured to engage a portion of the stomach wall; and

a functional device arranged to receive the guide so that the functional device may be guided with the guide to an attachment site from within the stomach.

3. The system of claim 2 wherein the guide further comprises an elongate portion extending from the first portion and within the stomach when the first portion extends into the stomach wall;

and wherein the functional device includes a guide opening for slidably receiving the elongate portion.

4. The system of claim 2 wherein said guide comprises a flexible tether.

5. The system of claim 2 wherein said guide comprises a guide wire.

6. A system for attaching a functional device to a stomach wall from within a stomach wherein the functional device is configured to perform a therapeutic or diagnostic function at the stomach, the system comprising:

a guide including a first portion arranged to extend from within the stomach through the stomach wall at an attachment site to the outside of the stomach wall; and

a functional device arranged to receive the guide so that the functional device may be guided with the guide to an attachment site from within the stomach;

wherein the functional device is an electrode device including an electrode, the electrode device being configured to couple the electrode to an electrical stimulation circuit for providing electrical stimulation through the electrode to a stomach wall, wherein the electrode device is arranged to receive the guide to guide it to an attachment site so that the electrode is in electrical contact with the stomach wall.

7. A system for attaching a functional device to a stomach wall from within a stomach wherein the functional device is configured to perform a therapeutic or diagnostic function at the stomach, the system comprising:

a guide including a first portion arranged to extend from within the stomach through the stomach wall at an attachment site to the outside of the stomach wall; and

a functional device arranged to receive the guide so that the functional device may be guided with the guide to an attachment site from within the stomach;

wherein the functional device is an electrical stimulator including an electrode, the stimulator configured to provide electrical stimulation through the electrode to a stomach wall, wherein the stimulator is arranged to receive the guide to guide the stimulator to an attachment site so that the electrode is in electrical contact with the stomach wall.

8. A system for attaching a functional device to a stomach wall from within a stomach wherein the functional device is configured to perform a therapeutic or diagnostic function at the stomach, the system comprising:

a guide including a first portion arranged to extend from within the stomach through the stomach wall at an attachment site to the outside of the stomach wall; and

a functional device arranged to receive the guide so that the functional device may be guided with the guide to an attachment site from within the stomach;

wherein the first portion comprises an electrode and the functional device comprises an electrical stimulator configured to electrically couple to the electrode so that electrical stimulation pulses may be delivered from the stimulator to the stomach wall through the electrode.

9. A method for treating or diagnosing a patient comprising the steps of:

providing a functional device configured to perform a therapeutic or diagnostic function at the stomach,

placing a guide from within the stomach with a portion of the guide placed from within the stomach extending through the stomach wall at an attachment site;

coupling the functional device to the guide; and

guiding the functional device with the guide to the attachment site from within the stomach.

10. A system for attaching a functional device to a stomach wall from within a stomach wherein the functional device is configured to perform a therapeutic or diagnostic function at the stomach, the system comprising:

a guide including a first portion arranged to extend from within the stomach into the stomach wall at an attachment site, wherein the first portion of the guide comprises an anchor configured to engage a portion of the stomach wall and a second portion coupled to the first portion and arranged to extend into the stomach when the first portion extends into the stomach wall; and

a functional device arranged to receive the second portion of the guide to guide the functional device from within the stomach towards the first portion at the attachment site.

11. The system of claim 10 wherein the second portion comprises an elongate portion coupled to the first portion;

and wherein the functional device includes a guide opening for slidably receiving the elongate portion after the first portion is positioned to extend into the stomach.

12. The system of claim 10 wherein said guide comprises a flexible tether.

13. The system of claim 10 wherein said guide comprises a guide wire.

14. A system for attaching a functional device to a stomach wall from within a stomach wherein the functional device is configured to perform a therapeutic or diagnostic function at the stomach, the system comprising:

a guide including a first portion arranged to extend from within the stomach into the stomach wall at an attachment site and a second portion coupled to the first portion and arranged to extend into the stomach when the first portion extends into the stomach wall; and

a functional device arranged to receive the second portion of the guide to guide the functional device from within the stomach towards the first portion at the attachment site;

wherein the first portion comprises an electrode and the functional device comprises an electrical stimulator configured to electrically couple to the electrode so that electrical stimulation pulses may be delivered from the stimulator to the stomach wall through the electrode.

15. A system for attaching a functional device to a stomach wall from within a stomach wherein the functional device is configured to perform a therapeutic or diagnostic function at the stomach, the system comprising:

a guide including a first portion arranged to extend from within the stomach into the stomach wall at an attachment site and a second portion coupled to the first portion and arranged to extend into the stomach when the first portion extends into the stomach wall; and

a functional device arranged to receive the second portion of the guide to guide the functional device from within the stomach towards the first portion at the attachment site;

wherein the functional device is an electrode device including an electrode, the electrode device being configured to couple the electrode to an electrical stimulation circuit for providing electrical stimulation through the electrode to a stomach wall, wherein the electrode device is arranged to receive the guide to guide it to an attachment site so that the electrode is in electrical contact with the stomach wall.

16. A system for attaching a functional device to a stomach wall from within a stomach wherein the functional device is configured to perform a therapeutic or diagnostic function at the stomach, the system comprising:

a guide including a first portion arranged to extend from within the stomach into the stomach wall at an attachment site and a second portion coupled to the first portion and arranged to extend into the stomach when the first portion extends into the stomach wall; and

a functional device arranged to receive the second portion of the guide to guide the functional device from within the stomach towards the first portion at the attachment site;

wherein the functional device is an electrical stimulator including an electrode, the stimulator configured to provide electrical stimulation through the electrode to a stomach wall, wherein the stimulator is arranged to receive the guide to guide the stimulator to an attachment site so that the electrode is in electrical contact with the stomach wall.

17. A system for attaching a functional device to a stomach wall from within a stomach wherein the functional device is configured to perform a therapeutic or diagnostic function at the stomach, the system comprising:

a guide including a first portion arranged to extend from within the stomach through the stomach wall at an attachment site to the outside of the stomach wall;

a functional device arranged to receive the guide so that the functional device may be guided with the guide to an attachment site from within the stomach; and

an electrode configured to be positioned in electrical contact with the stomach wall wherein the functional device comprises an electrical stimulator configured to deliver electrical stimulation to the stomach wall through the electrode.

18. A system for attaching a functional device to a stomach wall from within a stomach wherein the functional device is configured to perform a therapeutic or diagnostic function at the stomach, the system comprising:

a guide including a first portion arranged to extend from within the stomach through the stomach wall at an attachment site to the outside of the stomach wall;

a functional device arranged to receive the guide so that the functional device may be guided with the guide to an attachment site from within the stomach; and

wherein the guide comprises an electrode configured to be positioned in electrical contact with the stomach wall.

19. The system of claim 18 wherein the functional device comprises an electrical stimulator configured to deliver electrical stimulation to the stomach wall through the electrode.

20. A system for attaching a functional device to a stomach wall from within a stomach wherein the functional device is configured to perform a therapeutic or diagnostic function at the stomach, the system comprising:

a guide including a first portion arranged to extend from within the stomach into the stomach wall at an attachment site and a second portion coupled to the first portion and arranged to extend into the stomach when the first portion extends into the stomach wall;

a functional device arranged to receive the second portion of the guide to guide the functional device from within the stomach towards the first portion at the attachment site; and

an electrode configured to be positioned in electrical contact with the stomach wall wherein the functional device comprises an electrical stimulator configured to deliver electrical stimulation to the stomach wall through the electrode.

21. A system for attaching a functional device to a stomach wall from within a stomach wherein the functional device is configured to perform a therapeutic or diagnostic function at the stomach, the system comprising:

a guide including a first portion arranged to extend from within the stomach into the stomach wall at an attachment site and a second portion coupled to the first portion and arranged to extend into the stomach when the first portion extends into the stomach wall; and

a functional device arranged to receive the second portion of the guide to guide the functional device from within the stomach towards the first portion at the attachment site;

wherein the guide comprises an electrode configured to be positioned in electrical contact with the stomach wall.

22. The system of claim 21 wherein the functional device comprises an electrical stimulator configured to deliver electrical stimulation to the stomach wall through the electrode.