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Diagnostic device and method

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Publication number
US3688763A
US3688763A US3688763DA US3688763A US 3688763 A US3688763 A US 3688763A US 3688763D A US3688763D A US 3688763DA US 3688763 A US3688763 A US 3688763A
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Prior art keywords
sponge
patient
casing
intestine
large
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
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Raymond Cromarty
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RAYMOND CROMARTY
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RAYMOND CROMARTY
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891Coated capsules; Multilayered drug free capsule shells

Abstract

Cellular material is collected from the large intestine of a patient on a sponge. The patient swallows the sponge contained compressed in a gelatin casing with an enteric coating, the casing being dissolved in the large intestine to release the sponge, which is naturally evacuated by the patient and recovered for analysis.

Description

O United States Patent 51 3,688,763

Cromarty Sept. 5, 1972 [54] DIAGNOSTIC DEVICE AND METHOD 2,798,024 7/1957 Zapapas et al ..424/21 In entor: C marty Parmalea I Enz et a1 Crescent Weston Ontario Canada 3,315,660 4/1967 Abella ..128/2 F I 3,118,439 1/ 1964 Perrenoud 128/2 F [22] Filed: July 15, 1970 1,438,064 12/1922 Simmons ..128/260 471,343 3/1892 Poehl ..128/260 X [21] APPL R24,666 7/1959 Draghi ..12s/2 w 298,720 5/1884 Anderson ..128/269 X [30] Foreign Application Priority Data Primary Examinerl(yle L. Howell July 28, 1969 Great Britain ..37,84l/69 Att0mey Maybee & Legris [52] US. Cl. .JZB/Z B, 128/2 F, l28/2 W 57 ABSTRACT [51] Int. Cl. ..A6lb 10/00 [58] Field of Search 128/2 w 2 B, 2 F 2 p 2 R, Cellular material 18 collected from the large intestine 2 72 213 2 0 2 1 2 9. 424/ 9 22 Of a patient on a sponge. Tl'1 patient swallows the sponge contained compressed in a gelatin casing with [56] References Ciud an enteric coating, the casing being dissolved in the large intestine to release the sponge, which is naturally UNITED STATES PATENTS evacuated by the patient and recovered for analysis.

1,575,123 3/ 1926 Martocci-Pisculli...128l285 X 4 Claims, 1 Drawing Figure PATENTEDSEP 51912 3688.763

l NW-"EN'H R RAYMOND CROMARTY Attorneys DIAGNOSTIC DEVICE AND METHOD BACKGROUND OF THE INVENTION This invention relates to a diagnostic method for the detection of diseases and to a diagnostic device. More particularly, it relates to a method of and device for obtaining cellular material from the large intestine of a patient, for subsequent cytological examination.

BRIEF DESCRIPTION OF THE PRIOR ART It has previously been proposed to collect cells from the large intestine of a patient, for subsequent analysis, by injecting the patient anally with a polymerizable liquid composition. The composition polymerizes in situ in the body cavity to form a cellular, sponge-like mass, upon which cells from the body cavity deposit. The sponge-like mass is evacuated by the normal defecatory process of the patient, recovered, and the cells deposited thereon, removed and analyzed.

Such a procedure has the disadvantage that it requires expensive composition and equipment, and has to be carried out by skilled, medically trained personnel. It cannot be conducted by the patient himself, away from medical facilities.

SUMMARY OF THE INVENTION An object of the present invention is to provide a novel method of collecting cellular material from the large intestine of a patient, and a device therefor.

A further object is to provide a simple such method which can be conducted by the patient himself, and involves the use of an inexpensive device only.

According to one aspect of the present invention, there is provided a method of collecting cellular material from the large intestine of a patient, which comprises administering orally to the patient a capsule comprising a readily compressible sponge of fine pore structure enclosed in a gelatin or similar enzymedegradable casing, the casing having an enteric coating over its outer surface, recoveringthe sponge after its natural evacuation from the body, and recovering from the sponge cells collected thereon during its passage through the large intestine of the body.

According to a second aspect of the invention, there is provided a diagnostic device of an overall size such as to allow it to be swallowed by a patient and passed through the intestines of the body, said device comprising a sponge retained in compressed form inside a capsule, the capsule being insoluble in gastric juices of the stomach, but soluble to release the sponge in the large intestine.

BRIEF DESCRIPTION OF THE DRAWING The accompanying drawing shows an exploded view of a preferred embodiment of a diagnostic device according to the present invention.

The device is in the form of a capsule having two interfitting half shells l and 11, of circular cross section, of gelatin. Inside the shells of gelatin is provided a sponge 12. The sponge is compressed inside the shells, from a relaxed diameter of about 1 inch, to a diameter of about one-fourth inch, which is the approximate inner diameter of the gelatin shells.

After insertion of the sponge 12, the interfitting of the two half shells l0 and 11 to make a capsule, the

capsule is provided with an overall exterior enteric coating 13, which seals the capsule. The capsule is then ready to be administered to the patient. lts overall size is suitably three-fourths inch in length and one-fourth inch in diameter.

DESCRIPTION OF PREFERRED EMBODIMENTS The type of sponge is chosen with a view to easy compressibility, and very small adherence in relation to the walls of the intestines of the body. It must also, of course, be inert to the action of fluids present in the intestines, to which it will be exposed during use. Finely porous polyurethane sponge is suitable.

Suitable enteric coatings are those based on cellulose acetate phthalate. The coating may be applied in solvent form, for example as a solution in methylene chloride. The coating may also include additional ingredients such as plasticizers, e.g. ethyl phthalate, and non-friction aids, such as silicones.

In use, the capsule is swallowed by the patient, and passes into the stomach. Due to the presence of the enteric coating, the capsule remains unchanged and unaffected in the stomach, and passes into the small intestine. The secretions present in the small intestine start to attack the enteric coating and dissolve it. The gelatin shells are then attached by these secretions. Thus the capsule is disintegrated and the sponge released in the small intestine. The sponge is propelled along the intestines by the normal peristaltic action of the intestines, and eventually enters the large intestine. Here, the re-expanded sponge absorbs mucous, containing cells from the large intestine. The sponge travels on as before and is eventually naturally expelled from the anus, where it is carefully collected and the cells it has picked up removed and analyzed.

Preferably, the capsule is administered to the patient after a laxative, to clear the intestines of fecal material, and after several hours have elapsed since the patient consumed food. Further food should not be taken by the patient within about 7 hours after swallowing the capsule. This is to ensure that the sponge, when recovered,-is not contaminated with excessive amounts of fecal material, hindering analysis of the cells it has collected. The time from swallowing to emission of the sponge in the process of the present invention is normally about 12 hours.

By means of this invention, the presence of malignant cells in the large intestines can be determined, allowing early detection of pathological process of this organ.

What I claim as my invention is:

l. A method of collecting cellular material from the large intestine of a patient, which comprises fasting the patient, administering orally to the patient a capsule comprising an enzyme degradable casing, an enteric coating over the outer surface of said casing, and a readily compressible sponge of fine pore structure enclosed within said casing, recovering the sponge material after its natural evacuation from the body, and recovering from the sponge cells collected thereon during its passage through the large intestine of the body.

2. The method of claim 1 wherein the sponge is finely porous polyurethane sponge, and the casing is of gelatine.

4. A diagnostic device of an overall size such as to allow it to be swallowed by a patient and passed through the intestines of the body, said device being generally cylindrical in overall shape and comprising an enzyme degradable gelatine casing, a cellulose acetate phthalate based enteric coating over the outer surface of said casing, and a readily compressible and re-expandable finely porous polyurethane sponge retained and enclosed within said casing in a compressed form.

Claims (4)

1. A method of collecting cellular material from the large intestine of a patient, which comprises fasting the patient, administering orally to the patient a capsule comprising an enzyme degradable casing, an enteric coating over the outer surface of said casing, and a readily compressible sponge of fine pore structure enclosed within said casing, recovering the sponge material after its natural evacuation from the body, and recovering from the sponge cells collected thereon during its passage through the large intestine of the body.
2. The method of claim 1 wherein the sponge is finely porous polyurethane sponge, and the casing is of gelatine.
3. A method of collecting cellular material from the large intestine of a patient, which comprises fasting the patient, administering orally to the patient a capsule comprising an enzyme degradable gelatine casing, a cellulose acetate phthalate based enteric coating over the outer surface of said casing, and a readily compressible finely porous polyurethane sponge enclosed within said casing, recovering the sponge after its natural evacuation from the body, and recovering from the sponge cells collected thereon during its passage through the large intestine of the body.
4. A diagnostic device of an overall size such as to allow it to be swallowed by a patient aNd passed through the intestines of the body, said device being generally cylindrical in overall shape and comprising an enzyme degradable gelatine casing, a cellulose acetate phthalate based enteric coating over the outer surface of said casing, and a readily compressible and re-expandable finely porous polyurethane sponge retained and enclosed within said casing in a compressed form.
US3688763A 1969-07-28 1970-07-15 Diagnostic device and method Expired - Lifetime US3688763A (en)

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GB3784169 1969-07-28

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Cited By (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3877464A (en) * 1972-06-07 1975-04-15 Andrew R Vermes Intra-uterine biopsy apparatus
US3998211A (en) * 1974-08-23 1976-12-21 Louis Bucalo Structures for growing cultures within human and animal bodies
FR2374048A1 (en) * 1976-12-20 1978-07-13 Bucalo Louis Liq. collecting probe for insertion into body cavity - has absorbent cotton plug and one way valve with discharge system
US4172446A (en) * 1974-12-20 1979-10-30 Louis Bucalo Apparatus for collecting body fluids
US4186730A (en) * 1974-08-23 1980-02-05 Louis Bucalo Methods for collecting body fluids
US4257427A (en) * 1973-02-05 1981-03-24 Louis Bucalo Method for collecting body fluids
US4735214A (en) * 1986-09-05 1988-04-05 Berman Irwin R Gastrointestinal diagnostic capsule and method of use
US4774962A (en) * 1985-09-23 1988-10-04 Walter Sarstedt Kunststoff-Spritzgusswerk Method of extracting human saliva
WO1989000403A1 (en) * 1987-07-13 1989-01-26 Huhtamäki Oy Device and method for the determination of incisional wound healing ability
US4817632A (en) * 1987-06-23 1989-04-04 Bioquant, Inc. Oral fluid collection article
US4979947A (en) * 1985-10-10 1990-12-25 Berman Irwin R Encapsulated expandible continence device
EP0542299A2 (en) * 1991-11-15 1993-05-19 Kanegafuchi Kagaku Kogyo Kabushiki Kaisha Ester linkage containing polymers for use in pharmaceutical preparations
US5231992A (en) * 1990-06-04 1993-08-03 Leon Arnaldo C Low-impact cervical cell and fluid collector
US5603950A (en) * 1990-08-14 1997-02-18 Ratjen; Werner Agent for oral intake
US5971942A (en) * 1996-12-03 1999-10-26 Gu; Howard H. Intestinal fluid sampler
WO2001017509A1 (en) * 1999-09-06 2001-03-15 Beisel Guenther Method for improving and maintaining bowel function as well as a method for the production thereof
WO2001017510A1 (en) * 1999-09-06 2001-03-15 Beisel Guenther Agent for stimulating bowel function and method for producing the same
WO2002015887A1 (en) * 2000-08-17 2002-02-28 Machines Industrielles Etablissements Consumable container
US20030072804A1 (en) * 2001-03-19 2003-04-17 The Procter & Gamble Company Use of non-digestible polymeric foams to sequester ingested materials thereby inhibiting their absorption by the body
US20030091610A1 (en) * 2001-03-19 2003-05-15 The Procter & Gamble Company Use of non-digestible polymeric foams to sequester ingested materials thereby inhibiting their absorption by the body
US20100291266A1 (en) * 2009-05-15 2010-11-18 Tibor Czinki Natural Sponge Food and Regimen
US8491495B1 (en) * 2012-11-16 2013-07-23 L. Zane Shuck Human intestinal tract research and diagnostic system to evaluate patients and advance medical science and bioengineering and to determine processes in the gut and causes of diseases
US20140163416A1 (en) * 2012-11-16 2014-06-12 L. Zane Shuck In Vivo Device and Method for Researching GI Tract Processes, Microbes, and Variables Associated with Illnesses and Diseases
US20140162305A1 (en) * 2012-11-30 2014-06-12 L. Zane Shuck Patient In Vivo Gut Diagnostic and Treatment Tool
US20150112166A1 (en) * 2012-11-16 2015-04-23 L. Zane Shuck In Vivo Technology System for Human Gut Research, Diagnostics and Treatment

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2039219B (en) * 1978-03-22 1982-10-06 Pawelec J Device for study of the alimentary canal

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US24666A (en) * 1859-07-05 Improvement in revolving fire-arms
US298720A (en) * 1884-05-20 Capsule
US471343A (en) * 1892-03-22 Alexander poehl
US1438064A (en) * 1921-11-16 1922-12-05 Johnson & Johnson Dental pellet
US1575123A (en) * 1922-08-01 1926-03-02 Martocci-Pisculli Leon Medical appliance
US2798024A (en) * 1954-06-02 1957-07-02 Lilly Co Eli Composite enteric tablet of erythromycin and sulfonamides
US3081233A (en) * 1960-08-08 1963-03-12 Upjohn Co Enteric-coated pilules
US3118439A (en) * 1957-04-09 1964-01-21 Perrenoud Jean-Pierre Diagnostic and medicating capsule and the method of use
US3315660A (en) * 1963-08-08 1967-04-25 Carlos A Abella Capsule for insertion in the digestive track

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US24666A (en) * 1859-07-05 Improvement in revolving fire-arms
US298720A (en) * 1884-05-20 Capsule
US471343A (en) * 1892-03-22 Alexander poehl
US1438064A (en) * 1921-11-16 1922-12-05 Johnson & Johnson Dental pellet
US1575123A (en) * 1922-08-01 1926-03-02 Martocci-Pisculli Leon Medical appliance
US2798024A (en) * 1954-06-02 1957-07-02 Lilly Co Eli Composite enteric tablet of erythromycin and sulfonamides
US3118439A (en) * 1957-04-09 1964-01-21 Perrenoud Jean-Pierre Diagnostic and medicating capsule and the method of use
US3081233A (en) * 1960-08-08 1963-03-12 Upjohn Co Enteric-coated pilules
US3315660A (en) * 1963-08-08 1967-04-25 Carlos A Abella Capsule for insertion in the digestive track

Cited By (34)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3877464A (en) * 1972-06-07 1975-04-15 Andrew R Vermes Intra-uterine biopsy apparatus
US4257427A (en) * 1973-02-05 1981-03-24 Louis Bucalo Method for collecting body fluids
US3998211A (en) * 1974-08-23 1976-12-21 Louis Bucalo Structures for growing cultures within human and animal bodies
US4186730A (en) * 1974-08-23 1980-02-05 Louis Bucalo Methods for collecting body fluids
US4172446A (en) * 1974-12-20 1979-10-30 Louis Bucalo Apparatus for collecting body fluids
FR2374048A1 (en) * 1976-12-20 1978-07-13 Bucalo Louis Liq. collecting probe for insertion into body cavity - has absorbent cotton plug and one way valve with discharge system
US4774962A (en) * 1985-09-23 1988-10-04 Walter Sarstedt Kunststoff-Spritzgusswerk Method of extracting human saliva
US4979947A (en) * 1985-10-10 1990-12-25 Berman Irwin R Encapsulated expandible continence device
US4735214A (en) * 1986-09-05 1988-04-05 Berman Irwin R Gastrointestinal diagnostic capsule and method of use
US4817632A (en) * 1987-06-23 1989-04-04 Bioquant, Inc. Oral fluid collection article
WO1989000403A1 (en) * 1987-07-13 1989-01-26 Huhtamäki Oy Device and method for the determination of incisional wound healing ability
US5113871A (en) * 1987-07-13 1992-05-19 Jouko Viljanto Device for the determination of incisional wound healing ability
US5231992A (en) * 1990-06-04 1993-08-03 Leon Arnaldo C Low-impact cervical cell and fluid collector
US5603950A (en) * 1990-08-14 1997-02-18 Ratjen; Werner Agent for oral intake
EP0542299A2 (en) * 1991-11-15 1993-05-19 Kanegafuchi Kagaku Kogyo Kabushiki Kaisha Ester linkage containing polymers for use in pharmaceutical preparations
EP0542299A3 (en) * 1991-11-15 1993-06-02 Kanegafuchi Kagaku Kogyo Kabushiki Kaisha Ester linkage containing polymers for use in pharmaceutical preparations
US5576020A (en) * 1991-11-15 1996-11-19 Kanegafuchi Kagaku Kogyo Kabushiki Kaisha Adjuvant for pharmaceutical preparations
US5854368A (en) * 1991-11-15 1998-12-29 Kanegafuchi Kagaku Kogyo Kabushiki Kaisha Adjuvant for pharmaceutical preparations
US5644012A (en) * 1991-11-15 1997-07-01 Kanegafuchi Kagaku Kogyo Kabushiki Kaisha Adjuvant for pharmaceutical preparations
US5971942A (en) * 1996-12-03 1999-10-26 Gu; Howard H. Intestinal fluid sampler
WO2001017509A1 (en) * 1999-09-06 2001-03-15 Beisel Guenther Method for improving and maintaining bowel function as well as a method for the production thereof
WO2001017510A1 (en) * 1999-09-06 2001-03-15 Beisel Guenther Agent for stimulating bowel function and method for producing the same
WO2002015887A1 (en) * 2000-08-17 2002-02-28 Machines Industrielles Etablissements Consumable container
US20040022972A1 (en) * 2000-08-17 2004-02-05 Machines Industrielles Etablissements Consumable container
US20030072804A1 (en) * 2001-03-19 2003-04-17 The Procter & Gamble Company Use of non-digestible polymeric foams to sequester ingested materials thereby inhibiting their absorption by the body
US20030091610A1 (en) * 2001-03-19 2003-05-15 The Procter & Gamble Company Use of non-digestible polymeric foams to sequester ingested materials thereby inhibiting their absorption by the body
US20100291266A1 (en) * 2009-05-15 2010-11-18 Tibor Czinki Natural Sponge Food and Regimen
US8491495B1 (en) * 2012-11-16 2013-07-23 L. Zane Shuck Human intestinal tract research and diagnostic system to evaluate patients and advance medical science and bioengineering and to determine processes in the gut and causes of diseases
US20140163416A1 (en) * 2012-11-16 2014-06-12 L. Zane Shuck In Vivo Device and Method for Researching GI Tract Processes, Microbes, and Variables Associated with Illnesses and Diseases
US8915863B2 (en) * 2012-11-16 2014-12-23 L. Zane Shuck In vivo device and method for researching GI tract processes, microbes, and variables associated with illnesses and diseases
US20150112166A1 (en) * 2012-11-16 2015-04-23 L. Zane Shuck In Vivo Technology System for Human Gut Research, Diagnostics and Treatment
US9215997B2 (en) * 2012-11-16 2015-12-22 L. Zane Shuck In vivo technology system for human gut research, diagnostics and treatment
US20140162305A1 (en) * 2012-11-30 2014-06-12 L. Zane Shuck Patient In Vivo Gut Diagnostic and Treatment Tool
US8926526B2 (en) * 2012-11-30 2015-01-06 L. Zane Shuck Patient in vivo gut diagnostic and treatment tool

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