Gastrointestinal system

• US 8,755,888 B2
• Filed: 03/13/2013
• Issued: 06/17/2014
• Est. Priority Date: 10/17/2012
• Status: Active Grant

• Current Assignee: Melcap Systems Ltd.
• Original Assignee: Melcap Systems Ltd.
• Inventors: Voznesensky, Boris, More, Josef
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US13/799,205
• Publication Number:
  US 20140107726A1
• Time in Patent Office: 461 Days
• Field of Search: 607/40
• US Class Current: 607/40
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/062 using magnetic field
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/392 Detecting gastrointestinal contractions
• CPC Class Codes: A61B 5/4238 stomach
• CPC Class Codes: A61B 5/4255 Intestines, colon or appendix
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula

Abstract

A gastrointestinal stimulation system includes a remote controlled capsule adapted for positioning in the gastrointestinal tract (GT) of a patient, in which the capsule is secured to the inner wall of the gastrointestinal tract (GT) of a patient by a magnetic coupling system. The capsule is configured to activate at least one chosen area of the patient'"'"'s GI tract, including when desired, the vagus nerve, thereby facilitating gastro motility or having other interaction with the GI tract, such as monitoring thereof. The remote controlled capsule also may be configured to activate patient'"'"'s lower esophageal sphincter (LES), stimulating the LES muscle and restoring the barrier between the stomach and the esophagus for treatment of Gastroesophageal reflux disease (GERD). The capsule also may be inserted to the anal canal for treatment of constipation.

Claims

1. A gastrointestinal electro stimulation system including:

(I) a remote controlled capsule adapted for ingression into the gastrointestinal tract of a patient,

(II) a remote control device for controlling and sharing information with said capsule, and

(III) a magnetic coupling system for securing said capsule within the gastrointestinal tract of the patient,

wherein said capsule has a main body portion and a plurality of electrodes arranged in electrical isolation from each other, said capsule containing;

(a) a first RF transceiver operative to receive capsule operating instructions from and to transmit information to said remote control device;

(b) a capsule control unit electrically coupled to said first RF transceiver and operative to process said received operating instructions;

(c) a pulse generator electrically coupled to said capsule control unit and to said electrodes and configured to activate said electrodes so as to emit electrical stimuli pulses in accordance with said operating instructions; and

(d) a power supply for supplying electrical power to said first RF transceiver, to said control unit and to said pulse generator,

wherein said remote control device comprises;

(e) a system control unit operative to generate said operating instructions;

(f) a second RF transceiver coupled to said system control unit and configured to transmit said operating instructions and to receive information from said first RF transceiver,

and wherein said magnetic coupling system comprises;

(g) a first magnetic element associated with said capsule and a second magnetic element configured for placement externally of the body of the patient,

wherein selectable operation of said pulse generator is operative to expose to electrical stimuli a portion of the gastrointestinal tract where said capsule is secured, and

wherein said capsule is further adapted for egression from the pyloric region of the gastrointestinal tract after at least a predetermined dwell time therein, and wherein said main body portion of said capsule includes;

at least one gastric juice-responsive expandable element adapted for storage within a storage compartment formed within said main body portion of said capsule; and

a gastric-juice responsive cover for said storage compartment which when closed, prevents said at least one expandable element from exposure to gastric juices and, when open, facilitates exposure of said at least one expandable element to gastric juices such that said element expands so as to be forced out of said storage compartment and so as to increase the overall size of said capsule system thereby preventing said system from egression from the pyloric region of the stomach,

wherein said at least one expandable element is connected to said main body portion of said capsule by means of a gastric-juice responsive releasable connector element.

2. A gastrointestinal electro stimulation system according to claim 1, wherein said gastric-juice responsive cover is formed of a first gastric-juice soluble substance which is soluble at a first predetermined rate so as to permit exposure of said expandable element to gastric juices after a first dwell time in the gastrointestinal tract of a patient, and

said gastric-juice responsive releasable connector element is formed of a second gastric-juice soluble substance which is soluble at a second predetermined rate so as to dissolve said connector element after a second dwell time in the gastrointestinal tract of a patient, said second dwell time being longer than said first dwell time,

wherein dissolution of said connector element causes detachment of said at least one expandable element from said main body portion of said capsule, thereby permitting egression of said capsule from the gastrointestinal tract.

3. A gastrointestinal electro stimulation system according to claim 2, wherein each said expandable element is adapted to expand to a size which is sufficiently small to permit egression thereof from the gastrointestinal tract.

4. An extendible capsule adapted for ingression into the gastrointestinal tract of a patient, which includes:

first and second capsule portions;

a resilient element disposed between said first and second capsule portions for normally urging them apart into an extended arrangement; and

a gastric juice-responsive release unit operative to retain said first and second capsule portions in a non-extended arrangement in a first operative state of said capsule, and further operative, in response to contact with gastric juices for at least a predetermined period of time to permit said capsule to move into a second operative state by mutual extension of said first and second capsule portions thereby to extend the effective length of said capsule.

5. An extendible capsule according to claim 4, wherein said gastric juice-responsive release unit includes:

a first gastric juice-responsive locking element for resisting an urging force of said resilient element, thereby locking together said first and second capsule portions in said non-extended arrangement when said capsule is in said first operative state; and

a second gastric juice-responsive, selectably releasable locking element operative to maintain a mechanical connection between said first and second capsule portions when said capsule is in said extended arrangement in said second operative state, wherein said first and second locking elements are adapted to selectably disconnect said first and second capsule portions from each other so as to move said capsule into a third operative state,

wherein, when said capsule is in said first operative state, said first locking element is deactivated, such that said resilient element is operative to force said first and second capsule portions and thus said capsule into said extended arrangement of said second operative state,

and wherein, said second locking element is subsequently deactivated so as to disconnect said first and second capsule portions from each other such that said capsule splits into two portions and moves into said third operative state.

6. An extendible capsule according to claim 5, wherein

said first gastric juice-responsive locking element is formed of a first gastric-juice soluble substance which is soluble at a first predetermined rate so as to permit extension of said capsule after a first dwell time in the gastrointestinal tract of a patient, and

said second gastric juice-responsive locking element is formed of a second gastric-juice soluble substance which is soluble at a second predetermined rate so as to disconnect said first and second capsule portions from each other after a second dwell time in the gastrointestinal tract of a patient, said second dwell time being longer than said first dwell time.

7. An extendible capsule according to claim 4, wherein said gastric juice-responsive release unit is formed of a solid substance which is soluble in gastric juices.

8. An extendible capsule according to claim 4, wherein said first capsule portion includes a main body portion formed of a dielectric material, and a first electrode, and said second capsule portion includes a second electrode,

wherein said first capsule portion contains:

(i) an RF transceiver operative to receive capsule operating instructions from a remote control unit and to transmit information thereto;

(ii) a capsule control unit electrically coupled to said RF transceiver and configured to process received operating instructions;

(iii) a pulse generator electrically coupled to said capsule control unit and to said first and second electrodes and configured to activate said first and second electrodes so as to emit electrical stimuli pulses in accordance with said processed operating instructions, and

(iv) a power supply for supplying electrical power to said RF transceiver, to said control unit and to said pulse generator,

and wherein upon extension of said capsule, said first and second electrodes are moved laterally apart so to increase the distance between them, and thus to expose a greater portion of the GI tract to said electrical stimuli pulses.

9. For use with a gastrointestinal capsule system which includes a capsule adapted for ingression into the gastrointestinal tract of a patient, and a magnetic coupling system for securing the capsule within the gastrointestinal tract of the patient, wherein the coupling system has a first magnetic element associated with the capsule and a second magnetic element configured for placement externally of the body of the patient,

at least one capsule-securing device implantable in the wall of the gastrointestinal tract at a selected location, said capsule-securing device including:

a location pin; and

a third magnetic element associated with said location pin,

wherein, when the capsule is located within the gastrointestinal tract of the patient, movement of the second magnetic element, externally of the patient'"'"'s body, to a position corresponding to that of said capsule-securing device, causes a corresponding movement of the first magnetic element and a consequent magnetic coupling of the first and said third magnetic elements, thereby to position said capsule at said selected location in the gastrointestinal tract.

10. A capsule securing device according to claim 9, wherein said location pin includes:

a pin head having an upper surface to which said third magnetic element is secured and a lower surface for engaging the wall of the gastrointestinal tract when implanted therein; and

a pin shaft extending from said lower surface and having a serrated outer edge for mechanically securing said device to the inner wall of the gastrointestinal tract.

11. The gastrointestinal system according to claim 9, wherein the system is a gastrointestinal system and the capsule is used for gastrointestinal electro stimulation, and wherein said capsule-securing device is formed of an electro-conductive material.