Aendoscopic instrument system@

• US 7,107,100 B2
• Filed: 11/07/2002
• Issued: 09/12/2006
• 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.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US10/291,449
• Publication Number:
  US 20030164304A1
• Time in Patent Office: 1,405 Days
• Field of Search: 607/40, 607/133, 607/124, 600/343, 600/350, 600/373, 600/380, 600/101, 600/546
• 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. An endoscopic system comprising:

an elongate stimulation member having a proximal portion and a distal portion;

at least one electrode located on said distal portion coupled to a conductor extending from said distal portion to said proximal portion; and

an electronic circuit comprising an output, said output coupled to said conductor at said proximal portion, said electronic circuit configured to deliver a stimulation signal to said electrode to elicit a muscle or neurological response; and

a sensing member having a sensor operative to sense the muscle or neurological response of a stomach wall to the stimulation signal.

2. The endoscopic system of claim 1 wherein said sensing member is located on said elongate stimulation member.

3. The endoscopic system of claim 1 wherein said sensing member is located on an elongate sensing instrument.

4. The endoscopic system of claim 1 wherein said sensing member comprises an endoscopic visualization portion.

5. The endoscopic system of claim 1 wherein said sensing member comprises a mechanical contraction sensor.

6. The endoscopic system of claim 1 wherein the sensor comprises an electrode.

7. The system of claim 1 wherein said device is configured to determine at least one stimulation parameter based on a muscle or neurological response sensed by the sensor.

8. An endoscopic instrument system comprising:

an elongate instrument means for accessing the inside of a stomach wall through an esophagus, said elongate instrument means having a distal portion; and

an electrical signal sensing means for sensing muscle or neurological electrical activity of a stomach wall, said electrical signal sensing means located on said distal portion of said elongate instrument means.

9. An endoscopic instrument system comprising:

an elongate instrument means for accessing the inside of a stomach wall through an esophagus said elongate instrument means having a distal portion;

an electrical stimulating means for electrically stimulating a stomach wall to elicit a muscle or neurological response, said stimulating means located on said distal portion of said elongate instrument means; and

a sensing means for sensing the muscle or neurological response of the stomach wall to electrical stimulation.

10. The endoscopic instrument system of claim 9 further comprising an adjusting means responsive to said sensing means, for adjusting a parameter of stimulation applied to said stomach in response to a sensed muscle or neurological response of the stomach wall to the electrical stimulation.

11. A device for optimizing stimulation to a portion of a gastrointestinal tract comprising:

an electrode configured to be electrically coupled to the portion of the gastrointestinal tract;

a stimulator configured to deliver a stimulation signal to the portion of the gastrointestinal tract through the electrode;

a contraction sensor positioned in proximity to the electrode, wherein the contraction sensor is configured to sense a muscle contraction response of the portion of the gastrointestinal tract resulting from the stimulation signal at the electrode.

12. A method for determining a location for attaching an electrode to a stomach for electrical stimulation comprising the steps of:

providing an elongate member having a distal portion wherein the distal portion comprises at least one electrode;

advancing the distal portion of the elongate member through the esophagus into the stomach so that the at least one electrode is in electrical contact with the stomach wall at a first location;

electrically stimulating the stomach with the electrode to elicit a muscle or neurological response and observing the muscle or neurological response to the stimulation; and

determining if the first location is a suitable location for attaching an electrode.

13. The method of claim 12 wherein the step of observing the muscle or neurological response comprises sensing mechanical contractions using a mechanical sensor.

14. The method of claim 13 wherein the step of providing the elongate member comprises providing a mechanical contraction sensor on the distal portion of the elongate member.

15. The method of claim 13 wherein the step of sensing mechanical contractions comprises sensing mechanical contractions with a strain gauge.

16. The method of claim 12 wherein the step of observing the muscle or neurological response comprises visually observing a response to stimulation.

17. A method for determining a effectiveness of at least one stimulation parameter for electrical stimulation of a stomach comprising the steps of:

providing an elongate member having a distal portion wherein the distal portion comprises at least one electrode;

advancing the distal portion of the elongate member through the esophagus into the stomach so that the at least one electrode is in electrical contact with the stomach wall at a first location;

electrically stimulating the stomach with the at least one electrode using at least one stimulation parameter and observing a muscle or neurological response to the stimulation; and

determining if the at least one stimulation parameter evokes a desired response.

18. The method of claim 17 wherein the step of observing the muscle or neurological response comprises sensing mechanical contractions using a mechanical sensor.

19. The method of claim 18 wherein the step of providing the elongate member comprises providing a mechanical contraction sensor on the distal portion of the elongate member.

20. The method of claim 18 wherein the step of sensing mechanical contractions comprises sensing mechanical contractions with a strain gauge.

21. The method of claim 17 wherein the step of observing the muscle or neurological response comprises visually observing a response to stimulation.

22. A method of determining a stimulation parameter for stimulating a portion of a gastrointestinal tract comprising the steps of:

providing an electrode electrically coupled to tissue of a gastrointestinal tract;

providing a stimulator coupled to the electrode and configured to deliver an electrical stimulation signal to the portion of the gastrointestinal tract through the electrode;

providing a contraction sensor in proximity to the electrode;

delivering an electrically stimulating signal to the portion of the gastrointestinal tract through the electrode; and

sensing muscle contraction of the portion of the gastrointestinal tract in proximity to the electrode.

23. An endoscopic instrument system comprising:

an elongate instrument configured to access the inside of a stomach wall through an esophagus, said elongate instrument having a distal portion; and

an electrical signal sensor configured to sense muscle or neurological activity of a stomach wall, said electrical signal sensor located on said distal portion of said elongate instrument.

24. An endoscopic instrument system comprising:

an elongate instrument configured to access the inside of a stomach wall through an esophagus said elongate instrument having a distal portion;

an electrical stimulator configured to electrically stimulate a stomach wall to elicit a muscle or neurological response, said stimulator located on said distal portion of said elongate instrument; and

a sensor configured to sense a the muscle or neurological response of the stomach wall to electrical stimulation.

25. The endoscopic instrument system of claim 24 further comprising a responsive element responsive to said sensor, and configured to adjust a parameter of stimulation applied to said stomach in response to a sensed muscle or neurological response of the stomach wall to the electrical stimulation.

26. An endoscopic system for sensing an evoked response of a gastrointestinal tissue of a patient, the system comprising:

an elongate member having an end effector, wherein the end effector includes at least one electrode configured to deliver a test stimulation signal to the gastrointestinal tissue, wherein the signal is configured to evoke a muscle or neurological response by the gastrointestinal tissue indicative of gastric motility; and

at least one sensor operative to sense contraction of the stomach wall, wherein the at least one sensor is operative to sense the muscle or neurological response.

27. An endoscopic system as in claim 26, wherein the at least one sensor is operative to sense a presence or absence of contraction of the gastrointestinal tissue.

28. An endoscopic system as in claim 26, wherein the at least one sensor is operative to sense a degree of contraction of the gastrointestinal tissue.

29. An endoscopic system as in claim 26, wherein the at least one sensor comprises a strain gauge.

30. An endoscopic system as claimed in claim 26 wherein the at least one electrode is operative to sense the muscle or neurological response.

31. An endoscopic system as in claim 26, wherein the at least one electrode is operative to sense electrical activity, electrical parameters or a combination of these.

32. An endoscopic system as in claim 26, wherein the end effector comprises a pair of electrode members coupled together by a hinge, each electrode member having one of the at least one electrodes disposed thereon.

33. An endoscopic system as in claim 32, further comprising a handle coupled with the elongate member, wherein manipulation of the handle rotates the electrode members about the hinge.

34. An endoscopic system as in claim 26, wherein the at least one electrode is coupled with an external stimulator/recorder unit which supplies the stimulation signal and records the sensed response.

35. An endoscopic system as in claim 26, wherein the elongate member is configured to extend through an esophagus of the patient.

36. An endoscopic system as in claim 35, wherein the gastrointestinal tissue comprises a stomach wall.