Gastric anchor and method

• US 7,016,735 B2
• Filed: 11/07/2002
• Issued: 03/21/2006
• 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., Imran, Mir A., Gandhi, Deepak R., Colliou, Oliver K.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US10/290,788
• Publication Number:
  US 20040024427A1
• Time in Patent Office: 1,230 Days
• Field of Search: 607/40, 607/41, 607/133, 607/116, 607/72, 607/73, 607/138, 607/143, 600/377, 600/29, 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 configured to be electrically coupled to the electronic circuitry, and configured to be positioned in electrical contact with the stomach tissue; and

an attachment device coupled to the housing and operative to attach the housing from within a stomach cavity to a stomach wall;

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

2. The gastric stimulation device of claim 1 wherein the at least one stimulating electrode is located on the attachment device.

3. The gastric stimulation device of claim 1 wherein the at least one stimulating electrode is located on the housing.

4. The gastric stimulation device of claim 1 further comprising an electrode anchoring device, wherein the electrode anchoring device is configured to attach the at least one electrode in electrical contact with a stomach wall.

5. The gastric stimulation device of claim 4 wherein the at least one electrode is coupled through the attachment device to the electronic circuitry.

6. The gastric stimulation device of claim 1, wherein the attachment device comprises a first portion arranged to extend into the stomach wall.

7. The gastric stimulation device of claim 6 wherein the at least one electrode is located on-the first portion of the attachment device so that the at least one electrode is located within the stomach wall when the stimulation device is attached to the stomach wall.

8. The gastric stimulation device of claim 6 wherein when the attachment device is deployed, the first portion extends through the stomach wall in an orientation substantially perpendicular to the stomach wall.

9. The gastric stimulation device of claim 6 wherein the attachment device comprises an expandable portion configured to expand to attach the attachment device to the stomach wall.

10. The gastric stimulation device of claim 9 wherein the expandable portion is located distally of the first portion.

11. The gastric stimulation device of claim 10 wherein when deployed, the expandable portion is configured to engage the outer surface of the stomach wall.

12. The gastric stimulation device of claim 1 further comprising:

an anchor configured to fix the at least one electrode to the stomach wall, the anchor comprising;

a first portion arranged to extend into the stomach wall when the anchor is attached to the stomach wall; and

a second more distal portion with respect to the first portion, wherein when the attachment device is deployed, the second more distal portion engages the stomach wall to prevent the first portion from moving in a proximal direction out of the stomach wall.

13. The gastric stimulation device of claim 12 wherein the anchor further comprises a third more proximal portion with respect to the first portion, wherein when the attachment device is deployed, the third more proximal portion engages the stomach wall to prevent the first portion from moving in a proximal direction out of the stomach wall.

14. The gastric stimulation device of claim 12 wherein the at least one electrode is located on the first portion.

15. The gastric stimulation device of claim 1 wherein the attachment device comprises a release mechanism operative to release the attachment device from engagement with the stomach wall.

16. The gastric stimulation device of claim 1, wherein attachment device comprises an anchor removably attachable to the housing wherein the anchor is configured to attach the housing to the stomach.

17. The gastric stimulation device of claim 16, wherein the attachment device comprises a release mechanism operative to release the housing from the anchor.

18. The gastric stimulation device of claim 1 wherein the attachment device further comprises at least one laterally extending member arranged to be deployed to extend laterally of the attachment device within the stomach wall.

19. The gastric stimulation device of claim 18 wherein the at least one laterally extending member is configured to secure the attachment device to the stomach wall.

20. The gastric stimulation device of claim 18 wherein the at least one laterally extending member comprises a first electrode located thereon.

21. The gastric stimulation device of claim 20 further comprising a second electrode wherein the laterally extending member is adjustable to vary the distance between the first electrode and the second electrode.

22. The stimulation device of claim 1 wherein the electronic circuitry comprises telemetry circuit configured to receive a telemetry signal from art external device.

23. The stimulation device of claim 22 wherein the telemetry signal comprises a representative signal configured to control the electrical stimulation delivered to the stomach wall through the at least one electrode.

24. The stimulation device of claim 22 further comprising an external device comprising a telemetry circuit configured to emit the telemetry signal.

25. The gastric stimulation device of claim 24 wherein the external device further comprises a patient actuable control device coupled to the external device, wherein the patient actuable control device is configured to instruct the external control unit to transmit the representative signal upon patient actuation of the patient actuable control device.

26. The gastric stimulation device of claim 1 further comprising:

a sensor coupled to the stimulation device, the sensor operative to sense a parameter indicative of a condition of the patient.

27. The stimulation device of claim 26 wherein the sensor comprises the at least one electrode and wherein the electronic circuitry comprises an impedance determining circuit coupled to the at least one electrode.

28. The stimulation device of claim 26

wherein the sensor comprises the at least one electrode arranged to sense electrical activity of the stomach wall, and

wherein the electronic circuitry further comprises a circuit for determining the condition of the stomach from the electrical activity of the stomach wall sensed by the at least one electrode.

29. The stimulation device of claim 26 wherein the electronic circuitry comprises:

a controller coupled to the sensor, wherein the sensor is arranged to provide an electrical signal representative of the sensed information to the controller; and

a memory device coupled to the controller, the memory device including a stimulation program, wherein the controller is arranged to cause the at least one electrode to deliver the stimulation program in response to the sensed condition.

30. A gastric stimulation device of claim 1 wherein:

the housing is constructed of a first material resistant to corrosion when located within a stomach environment;

the housing further comprising an electrical connector arranged to electrically couple the at least one stimulating electrode to the electronic circuit; and

further comprising a sealing device operative to seal the connector from the stomach environment, wherein the sealing device is constructed of a sealing material resistant to corrosion from the stomach environment.

31. The gastric stimulation device of claim 30 wherein the first material is suitable for long-term use within a stomach.

32. The gastric stimulation device of claim 31 wherein the first material comprises a fluoropolymer.

33. The gastric stimulation device of claim 31 wherein the first material comprises titanium.

34. The gastric stimulation device of claim 30 wherein the sealing material is suitable for long-term use within a stomach.

35. The gastric stimulation device of claim 34 wherein the sealing material comprises a fluoropolymer.

36. 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 the housing within a stomach cavity to a stomach wall so that the at least one stimulating electrode is in electrical contact with the stomach wall;

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

37. A gastric stimulation device comprising:

housing means for containing electronic circuit means;

electrode means for electrically contacting stomach tissue, the electrode means electrically coupled to electronic circuit means;

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

an attachment means for attaching the housing means within a stomach cavity to a stomach wall.

38. The gastric stimulation device of claim 37 further comprising a disengaging means for disengaging the housing means from the stomach wall.

39. The gastric stimulation device of claim 37 further comprising an electrode anchor means for anchoring the electrode means to a stomach well so that the electrode means is in electrical contact with the stomach wall.

40. A method of stimulating a stomach wall comprising the steps of:

providing a gastric stimulator including a housing containing electronic circuitry therein, wherein the electronic circuitry is arranged to deliver electrically stimulating signals to the stomach wall through at least one stimulating electrode;

providing an attachment device for attaching the stimulator to the stomach wall;

providing at least one stimulating electrode;

advancing the gastric stimulator through the esophagus of a patient and towards an attachment site within the patient'"'"'s stomach; and

attaching the stimulator device to the attachment site with the attachment device.

41. The method of claim 40 further comprising the step of:

placing the at least one stimulating electrode in electrical contact with the stomach wall, whereby the at least one stimulating electrode is coupled to the electronic circuitry.

42. The method of stimulating a stomach wall of claim 41 further comprising the steps of:

providing an endoscopic instrument including a device for identifying a site for attaching the at least one electrode to the stomach wall; and

identifying the attachment site with the endoscopic instrument before attaching the at least one electrode to the attachment site.

43. The method of stimulating a stomach wall of claim 42 wherein the step of identifying the attachment site comprises electrically stimulating the site and observing the response.

44. The method of stimulating a stomach wall of claim 40 further comprising the steps of:

providing a stimulator engaging device; and

advancing the gastric stimulator through the esophagus and towards a stimulator attachment site within the stomach with the stimulator engaging device.