Title:
DIAGNOSTIC DEVICE AND METHOD
United States Patent 3688763
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.
US Patent References:
Medical appliance
Martocci-Pisculli - March 1926 - 1575123
Composite enteric tablet of erythromycin and sulfonamides
Zapapas et al. - July 1957 - 2798024
Enteric-coated pilules
Enz et al. - March 1963 - 3081233
Capsule for insertion in the digestive track
Abella - April 1967 - 3315660
Diagnostic and medicating capsule and the method of use
Perrenoud - January 1964 - 3118439
Medical appliance
Martocci-Pisculli - March 1926 - 1575123
Composite enteric tablet of erythromycin and sulfonamides
Zapapas et al. - July 1957 - 2798024
Enteric-coated pilules
Enz et al. - March 1963 - 3081233
Capsule for insertion in the digestive track
Abella - April 1967 - 3315660
Diagnostic and medicating capsule and the method of use
Perrenoud - January 1964 - 3118439
Inventors:
Raymond Cromarty, 10 Parmalea Crescent Weston
, CA.
, CA.
Application Number:
05/054945
Publication Date:
09/05/1972
Filing Date:
07/15/1970
View Patent Images:
Export Citation:
Primary Class:
Other Classes:
600/582
International Classes:
A61B10/00; A61K9/48; A61B10/00
Field of Search:
128/2W,2B,2F,2P,2R,172,213,260,261,269 424/19-22
US Patent References:
| 1438064 | Dental pellet | December 1922 | Simmons |
Primary Examiner:
Kyle, Howell L.
Attorney, Agent or Firm:
Maybee & Legris
Claims:
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.
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.
Description:
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.
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 enzyme-degradable casing, the casing having an enteric coating over its outer surface, 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.
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 10 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 10 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. Its 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.
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.
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 enzyme-degradable casing, the casing having an enteric coating over its outer surface, 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.
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 10 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 10 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. Its 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.