Pancreatic secretion response to stimulation test protocol

• US 6,612,983 B1
• Filed: 03/28/2000
• Issued: 09/02/2003
• Est. Priority Date: 03/28/2000
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Marchal, Benoit
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): MCCROSKY, DAVID J
• Application Number:
  US09/535,840
• Time in Patent Office: 1,253 Days
• Field of Search: 600/300, 600/301, 600/436, 600/554, 128/897-925, 607/40, 607/133
• US Class Current: 600/300
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

A screening test is used on a patient to determine if pancreatic secretion is responsive to stimulation. The screening test compares measurements of a pancreatic indicator both before and after natural stimulation. The pancreatic indicator is measured before natural stimulation and then the patient'"'"'s pancreas is naturally stimulated. After waiting a time period from when the natural stimulation began, the pancreatic indicator is once again measured. The difference between the pancreatic indicator measured before ingesting the meal and the pancreatic response indicator measured after ingesting and waiting a time period is calculated and a decision is made whether the patient has a pancreatic condition suitable for treatment with electrical stimulation. Additionally, an efficacy test is used to evaluate the efficacy of employing electrical stimulation to treat a pancreatic condition. Electrical stimulation is administered with a gastroelectric stimulator having a neurostimulator, an electrical lead, and electrodes placed in the patient'"'"'s abdomen at a location to stimulate the patient'"'"'s pancreas. The efficacy test compares a pancreatic response indicator before electrical stimulation and after electrical stimulation to decides whether there is efficacy in using electrical stimulation to treat a patient'"'"'s pancreatic condition.

Claims

1. A screening test for using gastroelectric stimulation to affect pancreatic exocrine secretion in a patient, comprising:

measuring a pancreatic response of a patient;

stimulating naturally the pancreatic secretion of the patient;

waiting a natural response time after the step of stimulating naturally the pancreatic secretion of the patient;

measuring the pancreatic response after waiting the natural response time;

calculating the difference between the pancreatic response measured before the step of stimulating naturally the pancreatic secretion of the patient and the step of waiting the natural response time after the step of stimulating naturally the pancreatic secretion of the patient;

deciding whether there is potential efficacy in using a gastroelectric stimulator to affect pancreatic exocrine secretions in the patient by evaluating the difference calculated in the step of calculating the difference between the pancreatic response measured before the step of stimulating naturally the pancreatic secretion of the patient and the step of waiting the natural response time after the step of stimulating naturally the pancreatic secretion of the patient.

2. The screening test for gastroelectric stimulation as in claim 1, further comprising comparing the difference between the patient'"'"'s pancreatic response measured before the step of stimulating naturally the pancreatic secretion of the patient and the pancreatic response measured after waiting the natural response time after the step of stimulating naturally the pancreatic secretion of the patient against predetermined screening data.

3. The screening test for gastroelectric stimulation as in claim 2 wherein the predetermined screening data are developed from statistical data on differences between the pancreatic response measured.

4. The screening test for gastroelectric stimulation as in claim 2 wherein predetermined data are developed for the patient by repeating the screening test at least two times on the patient.

5. The screening test for gastroelectric stimulation as in claim 1 wherein measuring pancreatic secretion is done with a specimen selected from the group consisting of:

blood, duodenal pancreatic secretion, and stool.

6. The screening test for gastroelectric stimulation as in claim 5 wherein duodenal pancreatic secretion is measured by isolating the patient'"'"'s duodenum with an upstream occlusion and a downstream occlusion to create an isolation area, evacuating duodenal pancreatic secretion from the isolation area, and measuring duodenal pancreatic secretion.

7. The screening test for gastroelectric stimulation as in claim 5 wherein pancreas response is measured by measuring a pancreatic secretion indicator in the specimen.

8. The screening test for gastroelectric stimulation as in claim 1 wherein the pancreatic response is measured by measuring a pancreatic exocrine secretion indicator.

9. The screening test for gastroelectric stimulation as in claim 8 wherein the pancreatic exocrine secretion indicator is selected from the group consisting of:

fat, elastase, amylase, and lipase.

10. The screening test for gastroelectric stimulation as in claim 1 wherein the pancreatic secretion indicator is a pancreatic endocrine response indicator.

11. The screening test for gastroelectric stimulation as in claim 10 wherein the pancreatic endocrine response indicator is selected from the group consisting of:

pancreatic polypeptide and insulin.

12. The screening test for gastroelectric stimulation as in claim 1 wherein the step of stimulating naturally the pancreatic secretion of the patient is selected from the group consisting of:

smelling food and ingesting food.

13. An efficacy test for gastroelectric stimulation to affect pancreatic exocrine secretion in a patient, comprising:

stimulating naturally a pancreas of a patient;

waiting a natural response time;

measuring a pancreatic response after waiting the first period of time;

stimulating electrically the patient'"'"'s pancreas with a stimulation signal and stimulating naturally the pancreas of the patient;

waiting an electrical response time;

measuring a pancreatic response in the patient'"'"'s blood after waiting the electrical response time;

calculating the difference between the pancreatic response measured after stimulating naturally and waiting the natural response time and the before stimulating naturally and the pancreatic response measured stimulating electrically the patient'"'"'s pancreas and waiting the electrical response time; and

,

deciding the efficacy of gastroelectric stimulation to treat pancreatic exocrine conditions.

14. The gastroelectric stimulator as in claim 13 wherein there is efficacy when the pancreatic response measured after the first predetermined period of time is lower than the pancreatic response measured after the second predetermined period of time.

15. The gastroelectric stimulator as in claim 13 wherein there is low efficacy when the pancreatic response measured after waiting the natural response time is substantially the same as the pancreatic response measured after waiting the electrical response time.

16. An efficacy test for a gastroelectric stimulator to affect pancreatic exocrine secretions in a patient, comprising:

providing a gastroelectric stimulator, comprising;

a neuroelectrical stimulator for producing a stimulation signal;

at least one electrical lead having a proximal end and a distal end, the proximal end being connected to the neuroelectrical stimulator and the distal end positionable in a lead position within the patient'"'"'s abdomen; and

,

at least two electrodes carried near the electrical lead distal end, the electrodes being electrically connected through the electrical lead to the neuroelectrical stimulator to receive the stimulation signal and convey this signal to an electrode position within the patient'"'"'s digestive system,

wherein the stimulation signal is adapted to influence pancreatic exocrine output;

stimulating naturally a pancreas of a patient;

waiting a natural response time;

measuring a pancreatic response after waiting the natural response time;

stimulating electrically the patient'"'"'s pancreas with a stimulation signal and

stimulating naturally the pancreas of the patient;

waiting an electrical response time;

measuring a pancreatic response in the patient'"'"'s blood after waiting the electrical response time;

calculating whether the pancreatic response measured after stimulating naturally and waiting the natural response time is higher or lower than the pancreatic response measured stimulating electrically the patient'"'"'s pancreas and waiting the electrical response time; and

,

deciding the efficacy of gastroelectric stimulation to treat pancreatic exocrine conditions.

17. The efficacy test for a gastroelectric stimulator as in claim 16 wherein electrodes are placed on the stomach.

18. The efficacy test for a gastroelectric stimulator as in claim 16 where the stimulation signal is 1.0 to 6,000 pulses per minute.

19. An efficacy test method for using a gastroelectric stimulator to treat duodenal osmotic imbalance in a patient, comprising:

isolating the patient'"'"'s duodenum near the pancreas to create a duodenum isolation area that substantially prevents fluid flow into or out of the isolation area;

perfusing a solution of increasing osmolity at an osmotic increase time period into the duodenum isolation area;

measuring a first duodenum osmolality level that causes nausea in the patient;

waiting an osmotic decrease time sufficient for the osmolality of the duodenum isolation area to reduce below the first duodenum osmolality level;

stimulating the patient'"'"'s pancreas using a gastroelectric stimulator;

perfusing a solution of increasing osmolality at the osmotic increase time period into the duodenum isolation area;

measuring a second duodenum osmolality level that causes nausea in the patient;

calculating the difference between the first duodenal osmolality level and the second duodenal osmolality level; and

,

deciding whether gastroelectric stimulation has efficacy for treating duodenal osmotic imbalance according to the difference between the first and second duodenal osmolality levels.

20. The efficacy test method as in claim 19, further comprising:

perfusing a marking solution above the duodenum isolation area to signal if fluid flows from above the duodenum isolation area into the duodenum isolation area.

21. The efficacy test method as in claim 19 wherein perfusing a solution of increasing osmolality at the osmotic increase time period into the duodenum isolation area is accomplished with a sodium chloride (NaCl) solution of increasing osmolality.

22. The efficacy test method as in claim 21 wherein the sodium chloride solution increases in osmolality in the range from about 100 mOsml/L NaCl to 1,000 mOsml/L NaCl.

23. The efficacy test method as in claim 19 wherein perfusing a solution of increasing osmolality at the osmotic increase time period into the duodenum isolation area is accomplished with a glucose solution of increasing osmoality.

24. The efficacy test method as in claim 19 wherein the osmotic increase time period for increasing the osmolatity of the perfusing solution is in the range from about 15 minutes to 60 minutes.

25. The efficacy test method as in claim 19 wherein a rate for perfusing solution is in the range from about 1.0 ml/minute to 9.0 ml/minute.

26. The efficacy test method as in claim 19, further comprising:

washing the duodenum isolated portion with an isotonic solution prior to perfusing to establish a baseline of osmolality.

27. The efficacy test method as in claim 19 wherein the duodenal isolation area contains the hepatopancreatic ampulla.

28. The efficacy test method as in claim 19 wherein the isolation area is created with an upstream occlusion and a downstream occlusion.

29. The efficacy test method as in claim 28 wherein the upstream occlusion and the downstream occlusion are balloons.

30. The efficacy test method as in claim 29 wherein the balloons are inflated to a pressure less than blood pressure.

31. The efficacy test method as in claim 19, further comprising:

sampling the duodenal isolation area osmolality at predetermined sampling intervals during perfusing.

32. The efficacy test method as in claim 31 wherein the predetermined sampling interval are in the range from about every 1.0 to 10 minutes.