US2701559A - Apparatus for exfoliating and collecting diagnostic material from inner walls of hollow viscera - Google Patents

Description

Feb. 8, 1955 w. A. COOPER 2,701,559 APPARATUS FOR EXFOLIATING AND COLLECTING DIAGNOSTIC MATERIAL FROM INNER WALLS 0F HOLLOW VISCERA Filed Aug. 2, 1951 SUCTION PRooucme MEANS AIR ' PRE SSURE.

Paooucms MEANS @474 1 ML a. f L L United States Patent APPARATUS FER EXFGLIATING AND COLLECT- ING DHAGNGSTIC MATERIAL FROM INNER WALLS 0F HOLLOW VISCERA William A. fiooper, New York, N. Y.

Application August 2, 1951, Serial No. 239,907

14 Claims. (Cl. 128-2) This invention relates to apparatus for obtaining diagnostic material by exfoliation ofliving cells from internal surfaces of hollow viscera, more particularly of the stomach and duodenum. I

Numerous attempts have been made to improve various technics for obtaining minute masses of cells from the lining of the stomach and/ or duodenum, so that such cells may be examined microscopically as an aid to the diagnosis of gastric pathology, including cancer of the stomach. Hitherto such technics have proved unsatisfactory because of the scanty amounts of. diagnostic material obtained thereby, principally through losses thereof by passage down the digestive tract, and also because of the rapid disintegration of such material by the digestive urces;

J A principal object of my invention is to provide an apparatus wherewith to obtain freshly exfoliated, minute masses of living cells from the inner walls of the stomach and duodenum, while at the same time avoiding injury to said Walls by the exfoliation, and avoiding deterioration of the removed cell groups by the action of digestive uices.

] Another object is to provide an apparatus including, as novel features thereof, an inflatable, abrasive balloon and an abrasive tip, adapted, respectively, for obtaining diagnostic material from the inner walls of the stomach and of the duodenum.

Still another object is to obtain, by exploratory test, exfoliated cellular material from various parts of the gastro-duodenal mucosa.

A further object is to provide an inflatable balloon having abradant fibers extending from and normal to the external surface thereof, whereby upon deflation of the balloon the fibers will move toward each other for the better gripping and protective retention between the clustered fibers of those cells which have been exfoliated from the lining of the stomach or other hollow viscera.

Other objects, uses, and advantages of my invention will appear from the following description, reference being had to the accompanying drawings, in which Fig. l is a general view of one embodiment of my t invention;

Fig. I! shows in vertical section an intermediate portion of the device of Fig. l

Fig. 3 is an enlarged sectional View on the line 3-3 of Fig. 2;

Fig. 4- illustrates a modified form of the invention showing the abrasive balloon in inflated condition;

Fig. 5 illustrates another form of abrasive means, showing the balloon in collapsed condition and a net enclosing the same; the net being shown as it would appear when supported by the balloon upon being inflated;

Fig. 6 is a view similar to Fig. 5, except that the net is omitted, and the collapsed balloon is shown partly cut away;

Fig. 7 shows, partly cut away, a third form of abrasive balloon, as well as the abrasive tip; and

Fig. 8 is a detail view of the abrasive tip and of parts adjacent thereto, shown to an enlarged scale.

Like numerals refer to like parts throughout the several views.

In the apparatus of Fig. 1, a first single-lumen tube 11 and a second single-lumen tube 12 are connected,

respectively, through tubes 13 and 14 of an adapter 15 (shown in detail in Fig. 2) to a first lumen 16 and a second lumen 17 of a double-lumen tube 18; the last being preferably of standard 16 French gauge. Tubes 11, 12, H

2,701,559 Patented Feb. 8, 1955 and 18 are flexible, and preferably are made of rubber.

The first lumen 16 of tube 18 opens into a hollow tip 19 having one or more perforations 20' through the wall thereof. The tip 19 is of a size to permit it to pass through the pylorus and into the duodenum; and it is preferably formed of, or plated with, a metal such as silver, which resists attack by the digestive juices. Tube 18 may be marked to indicate distances therealong of 45, 60, and centimeters (cm.-)- when measured from the end of tip 19.

The second lumen 17 of tube 18 is closed off by sealing means, such as by a plug 21 (Fig. 8).

Enclosing a length of about 8 cm. of tube 18, at its distal end, is an inflatable balloon 22, originally provided with an opening at each end thereof, as in Figs. 1, 4, 5, and 6, or With a single opening, as inv Figs. 7 and 8, for passage therethrough of the tip 19 and the tube 18. The balloon 22 preferably is formed of rubber latex of about the thickness of an ordinary toy balloon; but it may be formed of any other suitably impervious elastic material which is not attacked by the digestive juices. The shape of the balloon 22 is preferably such that the major part of its surface is cylindrical when it is inflated to a suitable degree (Figs. 1 and 4); its dimensions then being about 8 cm. to about 10 cm. in length, and about 2 cm. to about 5 cm. in diameter. When the balloon 22 is deflated, it collapses against the sides of the tube 18 (Figs. 5 and 6).

At the ends of said length of tube 18, the balloon 22, adjacent each end thereof, is attached air-tightly to the outside of tube 18, preferably by silk ties 23. Intermediate the ends of said length of tube 18 the external wall of the second lumen 17 thereof is provided with perforations 24 (Figs. 6 and 7) for passage of air into and out of the balloon 22 in the course of inflation and deflation thereof.

Distributed over the outer surface of the balloon 22 are numerous spaced-apart, porous, abradant bodies of an average dimension of about 2 millimeters (mm.); the various modifications thereof being adapted to exfoliate and to entrap living cells from the inner walls of a hollow viscus upon coming. into rubbing contact with said walls. Said bodies may be at distances apart of about 2 mm. to about 4 mm.

One form of said abradant bodies is shown in Figs. 1 and 7, as tufts 25, which are attached in any suitable manner to the outer surface of the balloon 22. Each tuft 25 is made up of a plurality of fibers or filaments; the free length of the individual fibers or filaments being about 2 mm. Such fibers may consist of textile threads or of fine rubber filaments, cemented to, or partly embedded in, the balloon 22.

A second form of my novel abradant bodies is shown in Fig. 4 as nodules 26 of a porous foam rubber, which are attached to the outer surface of the balloon 22.

A third form of said abradant bodies comprises knots 27 in a generally tubular open-weave veil or net 28 formed of textile fibers (Fig. 5). The net 28 encloses balloon 22, and is attached at its ends, along with the balloon 22, to the tube 18, by the ties 23. Each of knots 27 presents a loose, fuzzy exterior, which is adapted in exfoliate and to entrap living cells in a manner similar to that performed by the aforementioned tufts 25. When a form of my apparatus, which includes the net 28, it; being put to its intended use, the inflation of the balloon 22 presses the balloon against the interior of the net, including the knots 27, so that said knots are distributed over the surface of the balloon in tight engagement therewith, and operate as abradant bodies in the same general manner as do the tufts 25 and the nodules 26.

Connected to the outer end of tube 12 (Fig. l) is an ordinary compressible syringe air pump bulb 29, which is provided with an adjustable control valve 30 to permit deflation of the balloon 22. The balloon is inflatable only as to the portion thereof which is intermediate the ties 23 adjacent its two ends.

Connected to the outer end of tube 11 (Fig. l) is a three-way valve 31, which may be connected with any suitable suction means 9, or pressure producing means 10, indicated by blocks in Fig. 1, for aspirating materials entering the opening 20 in the tip 19, and for inflating a portion of the balloon, as will be described hereinafter with respect to the modification shown in Figs. 7 and 8 As will appear hereinafter, when the form of the invention shown in Figs. 7 and 8 is used, a compressible bulb air pump, like the pump 29, may be connected to one of the ports of the valve 31.

I may desire, however, to obtain diagnostic material from the inner walls of the duodenum; in which case I provide the tip 19 with an impervious inflatable cover 32, which preferably consists of a small area at the end of the balloon 22 which extends over the tip 19, as shown in Figs. 7 and 8. The outer surface of the cover 32 is provided with spaced apart tufts 2.5, in the manner that they are provided on the other portion of the balloon 22. When the tip 19 is provided with the cover 32, the former is no longer unobstructed, so that this form of the apparatus cannot be used to aspirate materials from a viscus into which the distal part of such apparatus is passed. By connecting a suitable air pump to the threeway valve 31, this cover portion 32 may be inflated so that it will conform to the shape of the duodenum and more effectively collect tissue cells from its walls.

I may designate generally as the distal part of my apparatus that portion thereof which is adapted to be swallowed and passed into the stomach, including the tip 19, the balloon 22, and the major portion of the double-lumen tube 18; and as the proximal part of the apparatus that portion thereof which normally does not enter the subjects mouth, including the adapter 15, tubes 11 and 12, bulb 29, and the three-way valve 31.

The following description of the use of my novel apparatus applies to the form thereof wherein the opening 20 in the tip 19 is unobstructed (Figs. 1, 4, 5, and 6).

All dentures are removed from the mouth of the subject, and the mouth is cleansed by rinsing. The deflated balloon 22 is dipped in Ringers solution and passed orally with the aid of small sips of the same solution. Local anesthesia of the posterior pharynx may be used to minimize the gag reflex. Once the balloon is past the epiglottis, it is advanced easily into the stomach as the subject swallows.

After the tube is beyond the 60 cm. mark, all gastric residue is aspirated and discarded. The balloon then is inflated with a quantity of air which has been shown by preliminary test to be suitable. Proper position is attained by withdrawing the tube until the inflated balloon, which is checked by meeting the cardia, causes a vomiting reflex. The latter furnishes a standard for the positioning of the balloon well within the stomach.

Peristalsis, initiated by inflation of the balloon, and aided by gentle manipulation of the tube 18, transfers the balloon from the cardia to the pylorus. The balloon is deflated at the pylorus so that it may enter the canal. Slow inflation of the balloon in the pyloric canal causes the balloon to move back into the antrum and it is then drawn back to the cardia. This procedure is repeated five or more times over a period of an hour so that the abradant bodies come in contact with the entire gastric mucosa. During this period it is preferable to continue gentle suction on an open exit of the three-way valve 31 so as to prevent interference of accumulating gastric juice with the contact of the abradant bodies with the mucosa. At the end of a suitable period of test, the balloon is deflated and withdrawn. In the laboratory any fragments of tissue seen on the silk or rubber tufts or brushes are removed by a cupped forceps and smeared directly onto slides prepared with a thin film of albumin. These slides are placed in an ether-alcohol fixative. The entire balloon is then promptly immersed in Ringers solution, and without delay is shaken in the solution until substantially all of the cells entrapped by the abradant bodies are dislodged and dispersed throughout the medium.

From this point on the routine methods of separation of the cells from the solution, fixation of the cells, smearing them on glass slides. staining the smears, and examining them microscopically, are carried out according to suitable cytologic procedures.

It will be observed that in the form of the invention shown in Figs. 1, 7, and 8, the tufts of fiber 25 spread out as the balloon is inflated, and move toward each other as the balloon is deflated, since they extend sub stantially normally to the external surface of the balloon. Thus when cells are loosened from the lining of the stomach by the brushing action of the fibers, the cells lodge between the fibers, and upon deflation of the balloon the fibers move toward one another, thereby tightly entrapping the cells and shielding and protecting the cells from decomposition by the gastric juices.

The technic of using the form of the apparatus wherein the tip 19 is provided with a cover 32, for the purpose of obtaining diagnostic material from the duodenum, does not differ materially from the technic just described, except in two respects. The first of these respects is that the stomach of the patient should be emptied as far as possible by any suitable procedure prior to the passage of such apparatus into the stomach; and that such passage should be accomplished without the aid of swallowed liquid and after preliminary light local anesthesia of the posterior pharynx. The second respect in which the above technic is changed is that, after deflation of the balloon at the pylorus, the covered tip 19 is permitted to pass into the duodenum, and the portion 32 of the balloon is inflated and permitted to remain in the duodenum until enough time has elapsed for the peristalsis set up in the duodenum to lead to a suitable exfoliation of the lining thereof. During this time the tube 18 may be gently manipulated at intervals to increase the scrubbing effect of the tufts on the cover 32.

I have employed representative embodiments of my novel apparatus in collecting cellular material from many scores of patients with clinical symptoms of gastric disease. The more important of my findings resulting from such tests are:

(1) Normal gastric mucosa resists mechanical exfoliation by the means and methods that I have described herein.

(2) Abnormally proliferating gastric cells, which are characteristic of malignancy, are fairly readily exfoliated by abradant means herein described.

(3) The ability to fix and stain such exfoliated cells with a minimum of delay yields better structural details under the microscope, and consequently definitely greater accuracy in recognizing malignant conditions.

Although the foregoing description relates to the preferred embodiment of my invention, various modifications and changes in minor details of my novel apparatus may be made without departing from the spirit of the invention as the same is defined in the appended claims.

I claim:

1. In apparatus of the character described, an inflatable balloon having attached to its external surface a plurality of spaced apart, porous, abradant bodies; each of said bodies comprising a small tuft of textile fibers; the free length of each fiber being of the order of two millimeters; said tufts being adapted to exfoliate and to entrap living cells from the inner walls of a hollow viscus upon coming into rubbing contact with said walls.

2. In apparatus of the character described, an inflatable balloon having attached to its external surface a plurality of spaced apart, porous, abradant bodies; each of said bodies comprising a small tuft of rubber filaments; the free length of each filament being of the order of two millimeters; said tufts being adapted to exfoliate and to entrap living cells from the inner walls of a hollow viscus upon coming into rubbing contact with said walls.

3. In apparatus of the character described, an infiatable balloon having attached to its outer surface a plurality of spaced apart, porous, abradant bodies; each of said bodies comprising a small mass of highly porous rubber of an average dimension of about two millimeters; said masses being adapted to exfoliate and to entrap living cells from the inner walls of a hollow viscus upon coming into rubbing contact with said walls.

4. In apparatus of the character described, the combination of a length of double-lumen tubing, means sealing the end of one lumen of the tubing at its distal end, an apertured tip which is adapted to pass through the pylorus and into the duodenum, means connecting the other lumen of the tubing to the apertured tip, an elongated inflatable balloon enveloping the distal end of the tubing and covering said tip, means securing the balloon air-tightly around the distal end portion of the tubing and also at a point spaced longitudinally along the tubing from the first point of securement and near the apertured tip thereby to provide two balloon sections, one of said balloon sections enveloping the tubing at its distal end and the other balloon section surrounding the apertured tip, a lateral perforation in said one lumenv providing: communication between the interior of said one lumen. and the interior of said one balloon section, a plurality of islands of tissue abrading material on the external surface of the portion of the balloon section surrounding the apertured' tip, said islands being adapted to'exfoliate and to entrap living cells from the inner walls of a hollow viscus such. as the duodenum up'on coming into' rubbing contact with the walls thereof, and means for separatel; controlling the inflation and deflation of the two balloon sections.

5. In an apparatus of the class described, the combination of a flexible tube having a closed end, a generally cylindrical flexible expansible balloon-like member secured over and sealed against the outer walls of the tube at longitudinally spaced positions thereon, lateral openings in the tube providing communication between the interior of the tube and the interior of the balloon-like member, means at the other end of the tube for forcing air into the balloon-like member, and dispersed small areas of fibrous material on the outer surface of the balloon-like member.

6. In an apparatus of the class described, the combination of a flexible tube having a closed end, a generally cylindrical flexible expansible balloon-like member secured over and sealed against the outer walls of the tube at longitudinally spaced positions thereon, lateral openings in the tube providing communication between the interior of the tube and the interior of the balloon-like member, means at the other end of the tube for forcing air into the balloon-like member, and a net of fibrous material enveloping the balloon-like member.

7. Apparatus for removing tissue cells from the walls of an internal cavity of the body, such as the stomach, comprising a flexible tube, an inflatable elastic balloonlike member connected to one end of the tube, means connected to the other end of the tube to inflate the member, and a plurality of exfoliating and cell-retaining projections on the external surface of the balloon.

8. Apparatus for exfoliating and collecting diagnostic material from the inner walls of internal viscera which comprises, an expansible elastic thin walled balloonlike member inflatable approximately to the size of the viscera into which it is to be inserted, a tubular means having one end secured to the member in airtight sealed relation and having an opening in communication with the interior of the member, means secured to the other end of the tubular means for supplying air under pressure through the tubular means to the member to inflate the latter and for providing a vent to the atmosphere when the member is to be deflated, and exfoliating and particulate matter collecting means around the external surface of the member.

9. The combination set forth in claim 8, in which the exfoliating and paticulate matter collecting means comprises a large number of abradant bodies distributed in spaced relation over the external surface of the balloon-like member.

10. The combination set forth in claim 8, in which the exfoliating and particulate matter collecting means comprises an open weave net formed of textile fibers enclosing the balloon-like member and secured to the tubular means in position to surround the balloon-like member when the latter is inflated.

11. Apparatus for exfoliating and collecting diagnostic material from the inner walls of internal viscera which comprises, proximal parts and distal parts, the proximal parts comprising a pair of single lumen tubes, means secured at the proximal end of one of the tubes selectively to supply air under pressure to the tube or to release air therefrom, means secured to the proximal end of the other tube selectively to apply air under pressure, or to produce a suction effect, the distal parts of said apparatus including the major portion of a length of double-lumen tube, means forming part of the proximal portion of the apparatus for connecting the other ends of the single lumen tubes respectively with the lumens of the double-lumen tube, the distal parts of the apparatus further including a metal point secured at the distal end of the double-lumen tube and having a passageway therein leading from the distal end of one of the lumens of the double-lumen tube to its external surface, means closing the distal end of the other lumen of the double-lumen tube, an elastic inflatable balloon-like member of sufficient size to en- 6 able it to be. inflated substantially to the size of the viscera into which it is to be inserted, means securing said member around the distal end portion of the double lumen tube and around said metal point; an opening inthe wall of the double-lumen tube: so as to communicate" the interior of that lumen having a closed distal end with the interior of the balloon-like member, means preventing communication between the portion of said member which surrounds the distal end of the double-lumen tube from that portion which surrounds the weighted end, and abradant exfoliating means around the outer surface of at least the portion of said member which surrounds the weighted end for exfoliating and collecting particulate matter from the walls of a smaller body cavity such as the duodenum adjacent a larger body cavity such as the stomach.

12. Apparatus for exfoliating and collecting diagnostic material from the inner walls of internal viscera which comprises, first and second single lumen tubes; means secured to one end of the first tube selectively to supply air under pressure to the tube or to release air therefrom; means secured to one end of the second tube selectively to apply air under pressure, or to produce a suction effect; a length of double-lumen tube having at one end first and second lumens respectively connected to the first and second single lumen tubes; a metallic element secured at the other end of the double-lumen tube and having a passageway therein leading from the first lumen of the double-lumen tube to its external surface; means closing the end of the second lumen near said element; an elastic inflatable balloon-like member of suflicient size to enable it to be inflated substantially to the size of the viscera into which it is to be inserted; means securing said member around the end portion of the double-lumen tube near said element, an opening in the wall of the double-lumen tube so as tocommunicate the interior of the second lumen with the interior of the balloon-like member; and abradant exfoliating means around the outer surface of said member for exfoliating and collecting particulate matter from the walls of viscera.

13. Apparatus for exfoliating and collecting diagnostic material from the inner walls of internal viscera which comprises, first and second single lumen tubes; means secured to one end of the first tube selectively to supply air under pressure to the tube or to release air therefrom; means secured to one end of the second tube selectively to apply air under pressure, or to produce a suction effect, a length of double-lumen tube having at one end first and second lumens respectively connected to the first and second single lumen tubes; a metallic element secured at the other end of the doublelumen tube and having a passageway therein leading from the first lumen of the double-lumen tube to its a external surface; means closing the end of the second lumen near said element; an elastic inflatable balloonlike member of suflicient size to enable it to be inflated substantially to the size of the viscera into which it is to be inserted; means securing said member around the end portion of the double-lumen tube and around said element, thereby preventing communication between the portion of said member which surrounds the doublelumen tube from that portion which surrounds said element; an opening in the wall of the double-lumen tube so as to communicate the interior of the second lumen with the interior of that portion of the balloonlike member which surrounds the double-lumen tube and abradant exfoliating means around the outer surface of at least the portion of said member which surrounds said element for exfoliating and collecting particulate matter from the walls of a smaller body cavity such as the duodenum adjacent a larger body cavity such as the stomach.

14. Apparatus for removing tissue cells from the walls of an internal cavity of the body, the combination of a thin wall elastic balloon-like member having a plurality of exfoliating and cell retaining fibers projecting from the external surface thereof, a flexible tube having one end connected to said member, and means connected to the other end of said tube for supplying air under pressure to inflate the member and having means for relieving the pressure to permit deflation of the member.

(References on following page) References Cited in the file of this patent UNITED STATES PATENTS Dorogi Sept. 17, 1935 Allyn Apr. 1, 1941 5 Winder Sept. 28, 1943 Wild Nov. 22, 1949 8 OTHER REFERENCES Surgery, April 1949, vol. 25, No. 4, page 603. A copy of this publication is available in Div. 55 of the Patent Ofiice.

American Journal of Clinical Pathology, vol. 19, No. 9, September 1949, pages 891-894. A copy of this publication is available at the Scientific Library of the Patent Ofiice.

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