Method and system for production and collection of lavage induced stool (LIS) for chemical and biologic tests of cells

• US 6,447,763 B1
• Filed: 06/12/1998
• Issued: 09/10/2002
• Est. Priority Date: 06/12/1998
• Status: Expired due to Term

• Current Assignee: Ian L. Gordon
• Original Assignee: Ian L. Gordon
• Inventors: Gordon, Ian L.
• Primary Examiner(s): Witz, Jean C.
• Application Number:
  US09/097,098
• Time in Patent Office: 1,551 Days
• Field of Search: 435/4, 424/439, 424/78.01, 514/892
• US Class Current: 424/78.01
• CPC Class Codes: A61B 10/0038 Devices for taking faeces samples; Faecal examination devices anal receptacles A61F5/451
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 33/06 Aluminium, calcium or magnesium; Compounds thereof , e.g. clay
• CPC Class Codes: A61P 1/10 Laxatives
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Beverages are provided and administered for producing LIS samples containing cells exfoliated from throughout the gut in sufficient numbers and free of interfering substances such as formed fecal particles for chemical assays and biologic assays for nucleic acid sequence information, and medical diagnosis. A kit is also provided for use by patients without assistance to produce a LIS sample suitable for analysis. A collection kit employs a sequence of the beverages and other ingested substances to produce preserved cells for medical diagnosis, allowing cytologic analysis of the LIS for diagnosis of foregut and hindgut disease. A preliminary cathartic lavage is used to cleanse a patient'"'"'s digestive tract; at least one stool induced by the preliminary cathartic lavage is collected; and a final cathartic lavage is used to exfoliate and preserve cells from a patient'"'"'s digestive tract. Time release capsules containing a cathartic medicament can also be used after completing preliminary lavage administration. The kit also allows provides apparatus for collection, sealing, and packing of the collected LIS specimen for analysis.

Claims

1. A method for producing lavage induced stools for chemical and biological tests of cells exfoliated from a patient'"'"'s digestive tract including intact cells exfoliated from the upper gut as well as the lower gut in quantities suitable for cytological examination and with sufficient preservation of morphology for the diagnosis of disease, comprising the steps of:

orally administering to a patient at least one preliminary substance selected from the group consisting of an oral cathartic and a lavage solution, to induce bowel motions and to cleanse the patient'"'"'s digestive tract; and

subsequently orally administering to the patient a cell exfoliating lavage solution different from said preliminary substance to increase exfoliation of intact cells from throughout the patient'"'"'s digestive tract including exfoliating cells from the upper gut as well as the lower gut, said cell exfoliating lavage solution containing a pH buffer to aid in preserving exfoliated cells for medical diagnosis of the patient'"'"'s digestive tract.

2. The method of claim 1, comprising administering a first lavage solution, followed by orally administering to a patient a final cathartic lavage solution, to minimize the amount of final cathartic lavage solution, compared to single, continuous lavage administration.

3. A method for producing lavage induced stools for chemical and biological tests of cells exfoliated from a patient'"'"'s digestive tract including intact cells exfoliated from the upper gut as well as the lower gut in quantities suitable for cytological examination and with sufficient preservation of morphology for the diagnosis of disease, comprising the steps of:

orally administering to a patient a first oral cathartic, followed by administering a second oral cathartic; and

subsequently orally administering to the patient a cell exfoliating lavage solution to increase exfoliation of intact cells from throughout the patient'"'"'s digestive tract including exfoliating cells from the upper and lower digestive tract, said cell exfoliating lavage solution containing a pH buffer to aid in preserving exfoliated cells for medical diagnosis of the patient'"'"'s upper and lower digestive tract.

4. A method for producing lavage induced stools for chemical and biological tests of cells exfoliated from a patient'"'"'s digestive tract including intact cells exfoliated from the upper gut as well as the lower gut in quantities suitable for cytological examination and with sufficient preservation of morphology for the diagnosis of disease, comprising the steps of:

orally administering to a patient at least one substance selected from the group consisting of an oral cathartic and a lavage solution, to induce bowel motions and to cleanse the patient'"'"'s digestive tract;

orally administering to the patient at least one exfoliant medication that affects the chemical composition of the induced stool, said exfoliant medication containing a pH buffer to aid in preserving exfoliated cells for medical diagnosis of the patient'"'"'s upper and lower digestive tract; and

orally administering to the patient a cell exfoliating lavage solution to increase exfoliation of intact cells from the patient'"'"'s upper and lower digestive tract including cells exfoliated from the upper gut as well as the lower gut, said exfoliating lavage solution containing a pH buffer to aid in preserving exfoliated cells for medical diagnosis of the patient'"'"'s upper and lower digestive tract.

5. A method for producing lavage induced stools for chemical and biological tests of cells exfoliated from a patient'"'"'s digestive tract including intact cells exfoliated from the upper gut as well as the lower gut in quantities suitable for cytological examination and with sufficient preservation of morphology for the diagnosis of disease, comprising the steps of:

orally administering to a patient a first lavage solution to induce bowel motions and to cleanse the patient'"'"'s digestive tract;

orally administering to the patient at least one exfoliant medication that affects the chemical composition of the induced stool, said cell exfoliant medication containing a pH buffer to aid in preserving exfoliated cells for medical diagnosis of cancer of the patient'"'"'s upper and lower digestive tract; and

orally administering to the patient a cell exfoliating lavage solution to increase exfoliation of intact cells from the patient'"'"'s upper digestive tract, said cell exfoliating lavage solution containing a pH buffer to aid in preserving exfoliated cells for medical diagnosis of cancer of the patient'"'"'s upper and lower digestive tract.

6. A method for producing lavage induced stools for chemical and biological tests of cells exfoliated from a patient'"'"'s digestive tract including intact cells exfoliated from the upper gut in quantities suitable for cytological examination and with sufficient preservation of morphology for the diagnosis of disease, comprising the steps of:

administering to the patient a first oral cathartic to induce bowel motions;

administering a second oral cathartic to the patient;

orally administering to the patient at least one exfoliant medication that affects the chemical composition of the induced stool, said cell exfoliant medication containing a pH buffer to aid in preserving exfoliated cells for medical diagnosis of cancer of the patient'"'"'s upper digestive tract; and

orally administering to the patient a cell exfoliating lavage solution to increase exfoliation of intact cells from the patient'"'"'s upper digestive tract, said cell exfoliating lavage solution containing a exfoliating agent selected from the group of inorganic salts, hormones, proteolytic enzymes, calcium chelating agents, EDTA, mucolytics, bile salts, and chenodeoxycholate, to induce increased exfoliation from the patient'"'"'s upper digestive tract, and containing a pH buffer to aid in preserving exfoliated cells for medical diagnosis of cancer of the patient'"'"'s upper digestive tract.

7. A method for producing lavage induced stools for chemical and biological tests of cells exfoliated from a patient'"'"'s digestive tract including intact cells exfoliated from the upper gut in quantities suitable for cytological examination and with sufficient preservation of morphology for the diagnosis of disease, comprising the steps of:

orally administering to a patient an oral cathartic to induce bowel motions;

orally administering to the patient a lavage solution to cleanse the patient'"'"'s digestive tract; and

orally administering to the patient a cell exfoliating lavage solution different from said oral cathartic and said lavage solution to increase exfoliation of intact cells from the patient'"'"'s upper digestive tract, said cell exfoliating lavage solution containing an exfoliating agent selected from the group of inorganic salts, hormones, proteolytic enzymes, calcium chelating agents, EDTA, mucolytics, bile salts, and chenodeoxycholate, to induce increased exfoliation from the patient'"'"'s upper digestive tract, and a pH buffer to aid in preserving exfoliated cells for medical diagnosis of cancer of the patient'"'"'s upper and lower digestive tract.

8. A method for producing lavage induced stools for chemical and biological tests of cells exfoliated from a patient'"'"'s digestive tract including intact cells exfoliated from the upper gut as well as the lower gut in quantities suitable for cytological examination and with sufficient preservation of morphology for the diagnosis of disease, comprising the steps of:

orally administering to a patient an oral cathartic to induce bowel motions;

orally administering to the patient a lavage solution to cleanse the patient'"'"'s digestive tract;

orally administering to the patient at least one exfoliant medication that affects the chemical composition of the induced stool, said cell exfoliant medication containing an exfoliating agent selected from the group of inorganic salts, hormones, proteolytic enzymes, calcium chelating agents, EDTA, mucolytics, bile salts, and chenodeoxycholate, to induce increased exfoliation of intact cells from the patient'"'"'s upper and lower digestive tract; and

orally administering to the patient a cell exfoliating lavage solution to increase exfoliation of intact cells from the patient'"'"'s upper digestive tract, said cell exfoliating lavage solution containing a pH buffer to aid in preserving exfoliated cells for medical diagnosis of cancer of the patient'"'"'s upper and lower digestive tract.

9. A method for producing lavage induced stools for chemical and biological tests of cells exfoliated from a patient'"'"'s digestive tract including intact cells exfoliated from the upper gut as well as the lower gut in quantities suitable for cytological examination and with sufficient preservation of morphology for the diagnosis, of disease, comprising the steps of:

orally administering to a patient an oral cathartic to induce bowel motions and to cleanse the patient'"'"'s digestive tract; and

subsequently orally administering to the patient a cell exfoliating lavage solution different from said preliminary substance to increase exfoliation of intact cells from throughout the patient'"'"'s digestive tract including intact cells exfoliated from the upper gut as well as lower gut, said cell exfoliating lavage solution containing an exfoliating agent to induce increased exfoliation from the patient'"'"'s upper and lower digestive tract and a pH buffer to aid in preserving exfoliated cells for medical diagnosis of the patient'"'"'s upper and lower digestive tract, said exfoliating agent being selected from the group of inorganic salts, hormones, proteolytic enzymes, calcium chelating agents, EDTA, mucolytics, bile salts, and chenodeoxycholate.

10. A method for producing lavage induced stools for chemical and biological tests of cells exfoliated from a patient'"'"'s digestive tract including intact cells exfoliated from the upper gut as well as the lower gut in quantities suitable for cytological examination and with sufficient preservation of morphology for the diagnosis of disease, comprising the steps of:

orally administering to a patient an oral cathartic to induce bowel motions and to cleanse the patient'"'"'s digestive tract;

orally administering to the patient at least one exfoliant medication that affects the chemical composition of the induced stool, said cell exfoliant medication containing an exfoliating agent selected form the group of inorganic salts, hormones, proteolytic enzymes, calcium chelating agents, EDTA, mucolytics, bile salts, and chenodeoxycholate, to induce increased exfoliation from the patient'"'"'s upper and lower digestive tract; and

subsequently orally administering to the patient cell exfoliating lavage solution different from said preliminary substance to increase exfoliation of intact cells from throughout the patient'"'"'s digestive tract including intact cells exfoliated from the upper gut as well as lower gut, said cell exfoliating lavage solution containing a pH buffer to aid in preserving exfoliated cells for medical diagnosis of the patient'"'"'s upper and lower digestive tract.