Gastric treatment and diagnosis device and method

• US 6,535,764 B2
• Filed: 05/01/2001
• Issued: 03/18/2003
• Est. Priority Date: 05/01/2001
• Status: Active Grant

• 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:
  US09/847,884
• Publication Number:
  US 20020165589A1
• Time in Patent Office: 686 Days
• Field of Search: 607/40, 607/41, 607/133, 607/116, 607/72, 607/73, 607/138, 607/143, 607/29, 600/30
• 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 gastric stimulation device comprising:

a housing;

electronic circuitry contained within the housing;

at least one stimulating electrode coupled to the housing and electrically coupled to the electronic circuitry; and

an attachment device coupled to the housing and operative to attach said housing within a stomach cavity to a stomach wall so that said at least one stimulating electrode is in electrical contact with the stomach wall;

wherein said electronic circuitry is configured to deliver electrically stimulating signals to the stomach through the at least one stimulating electrode;

wherein said attachment device comprises an anchor having a first portion arranged to extend into the stomach wall when said anchor is attached to the stomach wall; and

wherein said attachment device further comprises a distal portion wherein when said attachment device is deployed, said distal portion extends through said stomach wall, adjacent an outer surface of the stomach wall.

2. A gastric stimulation device comprising:

a housing;

electronic circuitry contained within the housing;

at least one stimulating electrode coupled to the housing and electrically coupled to the electronic circuitry; and

an attachment device coupled to the housing and operative to attach said housing within a stomach cavity to a stomach wall so that said at least one stimulating electrode is in electrical contact with the stomach wall;

wherein said electronic circuitry is configured to deliver electrically stimulating signals to the stomach through the at least one stimulating electrode; and

wherein said housing comprises a release mechanism operative to release the housing from the attachment device.

3. A gastric stimulation device comprising:

a housing;

electronic circuitry contained within the housing;

at least one stimulating electrode coupled to the housing and electrically coupled to the electronic circuitry; and

an attachment device coupled to the housing and operative to attach said housing within a stomach cavity to a stomach wall so that said at least one stimulating electrode is in electrical contact with the stomach wall;

wherein said electronic circuitry is configured to deliver electrically stimulating signals to the stomach through the at least one stimulating electrode;

wherein said attachment device comprises an anchor having a first portion arranged to extend into the stomach wall when said anchor is attached to the stomach wall

wherein said anchor comprises;

an expandable distal portion adjacent to said first portion, said expandable distal portion arranged to expand to secure the attachment device to the stomach wall.

4. The gastric stimulation device of claim 3 wherein said expandable distal portion comprises a spring mechanism biased in an expanded position.

5. The gastric stimulation device of claim 3 wherein said expandable distal portion comprises an inflatable member.

6. The gastric stimulation device of claim 5 further comprising an inflation medium for inflating said inflatable member.

7. The gastric stimulation device of claim 5 wherein said inflatable medium comprises a curable polymer.

8. The gastric stimulation device of claim 5 wherein said inflatable member is inflatable to a predetermined pressure.

9. The gastric stimulation device of claim 5 wherein said inflatable member in inflatable to a predetermined volumes.

10. The gastric stimulation device of claim 3 wherein said at least one electrode is located on said expandable distal portion.

11. The gastric stimulation device of claim 3 wherein said expandable distal portion further comprises an antibiotic material coated on at least a portion of said expandable distal portion.

12. The gastric stimulation device of claim 3 wherein said attachment device further comprises at least one lateral extending member arranged to be deployed to extend laterally of the attachment device within the stomach wall.

13. The gastric stimulation device of claim 12 wherein said at least one laterally extending member is configured to secure the attachment device to the stomach wall.

14. The gastric stimulation device of claim 12 wherein said at least one laterally extending member comprises an electrode located thereon.

15. The gastric stimulation device of claim 12 wherein said at least one laterally extending member comprises a strain gauge located thereon.

16. The gastric stimulation device of claim 14 wherein said laterally extending member is adjustable.

17. The gastric stimulation device of claim 12 wherein said at least one laterally extending member comprises a plurality of laterally extending members.

18. The gastric stimulation device of claim 17 wherein each of said plurality of laterally extending members comprises an electrode thereon.

19. The gastric stimulation device of claim 17 wherein said plurality of laterally extending members are selectably adjustable with respect to one another to vary the distance between each of said electrodes.

22. The stimulation device of claim 18 further comprising a bumper arranged to prevent further movement of the first portion through the stomach wall.

20. A gastric stimulation device comprising an anchor for attaching an electrode to a wall of a stomach, said anchor including:

a first portion arranged to extend into the stomach wall from within the stomach so that said electrode is in electrical contact with the stomach wall

wherein said first portion comprises a distal portion having an expandable portion arranged to expand to secure the anchor to the stomach wall.

21. A gastric stimulation device comprising an anchor for attaching an electrode to a wall of a stomach, said anchor including:

a first portion arranged to extend into the stomach wall from within the stomach so that said electrode is in electrical contact with the stomach wall;

wherein said first portion comprises a distal portion having an expandable portion arranged to expand to secure the anchor to the stomach wall; and

wherein said expandable portion is constructed to extend through the stomach wall and to expand adjacent on outer surface of the stomach wall.

23. A gastric stimulation device comprising:

a housing;

electronic circuitry contained within the housing;

at least one stimulating electrode coupled to the housing and electrically coupled to the electronic circuitry; and

an attachment device coupled to the housing and operative to attach said housing within a stomach cavity to a stomach wall so that said at least one stimulating electrode is in electrical contact with the stomach wall;

wherein said electronic circuitry is configured to deliver electrically stimulating signals to the stomach through the at least one stimulating electrode;

wherein said attachment device comprises an anchor having a first portion arranged to extend into the stomach wall when said anchor is attached to the stomach wall; and

wherein said anchor is removable and reattachable to said housing.

24. A gastric stimulation device comprising:

housing means for containing electronic circuit means;

electrode means coupled to the housing means and electrically coupled to the electronic circuit means;

electronic circuit means for delivering electrically stimulating signals to the stomach through said electrode means; and

an attachment means for attaching said housing means within a stomach cavity to a stomach wall so that said electrode means is in electrical contact with the stomach wall;

wherein said electrode means comprises at least one pair of bipolar electrodes, said stimulation device further comprising adjustable means for adjusting a distance between said bipolar electrodes.

25. A gastric stimulation device comprising:

housing means for containing electronic circuit means;

electrode means coupled to the housing means and electrically coupled to the electronic circuit means;

electronic circuit means for delivering electrically stimulating signals to the stomach through said electrode means;

an attachment means for attaching said housing means within a stomach cavity to a stomach wall so that said electrode means is in electrical contact with the stomach wall; and

a release means for latching and unlatching said housing means with said attachment means.

26. A gastric stimulation device comprising:

housing means for containing electronic circuit means;

electrode means coupled to the housing means and electrically coupled to the electronic circuit means;

electronic circuit means for delivering electrically stimulating signals to the stomach through said electrode means;

an attachment means for attaching said housing means within a stomach cavity to a stomach wall so that said electrode means is in electrical contact with the stomach wall; and

expandable means for expanding to secure said attachment means to the stomach wall.

27. A gastric stimulation device comprising:

an anchor means for attaching an electrode to a wall of a stomach from within a stomach cavity

wherein said anchor means comprises an expandable means for expanding to secure the anchor to a stomach wall.

28. The stimulation device of claim 27 wherein said anchor means comprises and electrode means located thereon.