Process and device for treating obesity and syndromes related to motor disorders of the stomach of a patient

• US 5,423,872 A
• Filed: 05/26/1993
• Issued: 06/13/1995
• Est. Priority Date: 05/29/1992
• Status: Expired due to Term

• Current Assignee: Transneuronix Inc. (Medtronic Plc)
• Original Assignee: Valerio Cigaina
• Inventors: Cigaina, Valerio
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US08/067,390
• Time in Patent Office: 748 Days
• Field of Search: 607/133, 607/72, 607/116, 607/40, 607/126, 607/128, 607/9
• US Class Current: 607/40
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

The process for treating obesity and syndromes related to motor disorders of the stomach of a patient consists in artificially altering, by means of sequential electrical pulses and for preset periods of time, the natural gastric motility of the patient to prevent emptying or to slow down gastric transit.

Claims

1. A process for treating obesity and syndromes related to motor disorders of the stomach of a patient, comprising the steps of:

(a) mounting an electrical stimulator subcutaneously on the abdominal wall and anchoring the stimulator onto the fascia of the musculus rectus abdominis;

(b) guiding an electrocatheter operatively connected with the stimulator along a path to place the electrocatheter in stomach wall tissue and to insert a tip of the electrocatheter in the seromuscular layer of the gastric antrum; and

(c) generating sequential electrical pulses for a preset period of time by the electrical stimulator and transmitting the electrical pulses through the tip to the stomach to stimulate the entire stomach, thereby artificially altering a natural gastric motility of a patient to be treated to slow down food transit through the stomach.

2. The process defined in claim 1 wherein the pulses are in a form of sinusoidal waves propagated along the entire stomach, the sinusoidal waves generated by the electrical stimulator being identical to sinusoidal waves generated naturally by a gastric pacemaker of the stomach.

3. The process defined in claim 1 wherein the electrical pulses are generated at a preset operating frequency, the preset period of time being varied according to an individual characteristics of a patient to be treated.

4. The process defined in claim 3 wherein the preset operating frequency varies from 2 to 15 pulses per minute.

5. The process defined in claim 1 wherein each of the pulses has a duration between 10 and 90 milliseconds and corresponds to a specific chronaxie defining excitability thresh old in terms of stimulus length.

6. The process defined in claim 1 wherein each of the pulses has a respective discharge varying from 1 to 10 volts and from 2 to 15 milliamperes DC according to electrical characteristics of the catheter and to a particular rheobase of a tissue to be stimulated.

7. The process defined in claim 1 wherein the step (b) includes placing the electrocatheter in the gastric parietal seat by using a laporascopic procedure.

8. The process define in claim 1 wherein the step (c) includes altering of a proper function of the lower esophageal, pyloric sphincters and the natural gastric motility of the patient to improve sphincter function and reflux disorders and to slow down gastric transit for preventing duodenal acidification caused by a faster interdigestive transit of a gastric juice.

9. A device for treating obesity and syndromes related to motor disorders of the stomach of a patient, the device comprising:

an electrical stimulator adapted to be applied subcutaneously on the abdominal wall and generating an operating frequency including from 2 to 15 pulses per minute; and

connecting means for operatively connecting the electrical stimulator with an area of the stomach of a patient to be treated, the connecting means comprising an electrocatheter guidable along an insertion direction and including;

an elongated internal stimulating conductor formed with a metallic conducting free end adapted for transmitting the pulses at the operating frequency over the area of the stomach to be treated to artificially alter a natural gastric motility of the patient for preventing emptying or slowing down food transit, for improving functioning of the lower esophageal or pyloric sphincters and for preventing acidification of the duodenum for a preset time,

a plurality of pointed but not sharp angled metallic barbs operatively connected with the conductor and spaced angularly from one another, the barbs extending in a direction opposite the direction of insertion for stabilizing contact between the electrocatheter and the viscus,

the barbs extending radially outwardly from the conducting end of the stimulating conductor, and

an insulating layer and with a flat velveted plastic expansion formed on a sheath and located proximate to the conducting end for anchoring the electrocatheter on the gastric serosa with a surgical stitch.

10. A device for treating obesity and syndromes related to motor disorders of the stomach of a patient, the device comprising:

an electrical stimulator adapted to be applied subcutaneously on the abdominal wall and generating an operating frequency including from 2 to 15 pulses per minute; and

connecting means for operatively connecting the electrical stimulator with an area of the stomach of a patient to be treated, the connecting means comprising an electrocatheter guidable along an insertion direction and including;

an elongated internal stimulating conductor formed with a metallic conducting free end adapted for transmitting the pulses at the operating frequency over the area of the stomach to be treated to artificially alter a natural gastric motility of the patient for preventing emptying or slowing down food transit, for improving functioning of the lower esophageal or pyloric sphincters and for preventing acidification of the duodenum for a preset time,

a plurality of pointed but not sharp angled metallic barbs operatively connected with the conductor and spaced angularly from one another, the barbs extending in a direction opposite the direction of insertion for stabilizing contact between the electrocatheter and the viscus,

a return conductor surrounding the stimulating conductor and spaced therefrom,

an insulating sheath between the stimulating and return conductors,

a rigid cylinder mounted on opposite ends of the return conductor, the cylinder being provided with the plurality of barbs, the barbs being elastic laminas provided with respective free ends and divaricating from inserting to anchoring positions, and

an insulating flexible tubular slider on the return conductor guidable therealong and provided with gripping means for engaging the laminas in the inserting position, the laminas spreading apart upon displacing of the slider to anchor the electrocatheter to the viscus.

11. The device defined in claim 10 wherein the gripping means includes a plurality of formations engaging respective free ends of the laminas in the inserting position, the free ends being inclined with respect to a peripheral surface of the catheter.

12. The device defined in claim 10 wherein the device is provided with control means for assessing electromechanical activity of a portion of the viscus in order to determine the sphincter stimulation time by means of a bipolar opening provided on the tubular slider.

13. The device defined in claim 12 wherein the control means includes a monopolar terminal or a transducer of muscular tension.

14. The device defined in claim 10 wherein the electrocatheter has up to three points of seromuscular contact, the gripping means including contact openings corresponding to the points for reception and/or stimulation of the stomach.

15. A process for treating obesity and motor disorders of the stomach-of a patient which comprises:

anchoring in tissue of the stomach at a location in a region of the antrum and on an outside of the stomach an electrode capable of producing an electrical wave propagatable over the stomach from the antrum; and

periodically energizing said electrode with 2 to 15 pulses per minute at a voltage of 1 to 5 volts with a constant current of 2 to 15 milliamperes for a duration of 10 to 90 milliseconds to limit movement of food through the stomach.