Dec. 21, 1965 4 N. MOLOMUT ETAI- 3,224,434
CELL COLLECTOR Filed Nov. 6, 1962 26 [l6 I7 1 FILTER 28 Q 477/ 1 3| //III1...... 40 v 4M 20 I I2 2I 24 25 Io 36 F/G-Z FlLTER., 4 i 35 F/6-5 6+ -7@ F/G-5 F/G-7 A B c D E F P 6 I 9 F e WASH USE REMOVE MR IN ORAL CCELL FILTER A To I TRANSFER I LAB E CAVITY TO DRY T TOR SLIDE R F/G'Q H e ADVISE OR DIAGNOSE INSPECT TREAT INVENTORS NORMAN MOLOMUT BY PAUL SCHEMAN Zd Q H m ATTORN EY United States Patent Oflflce 3,224,434 Patented Dec. 21, 1965 3,224,434 CELL COLLECTOR Norman Molomut, Flushing, and Paul Scheman, Freeport,
N.Y., assignors to Waldemar Medical Research Foundation, Inc., Port Washington, N.Y., a corporation of New York Filed Nov. 6, 1962, Ser. No. 235,693 4 Claims. (Cl. 1282) This invention relates to a device for, and the method of, obtaining samples of cells from the bodies of animate beings, such as human beings, for clinical observation and testing to determine the existence of disease, particularly cancer.
The method and means of determining whether cells taken from tissue are normal cells, or cancerous, are well known in the art. Usually, tissue is taken and embedded in wax and sectioned. It is then stained and treated to remove water in the wax so that it can be observed under a microscope for determination by the clinician.
This prior art method has several distinct disadvantages. First, it requires cutting the patient to remove the tissue to be examined. Second, it is a time consuming procedure, and the results are not immediate. Third, there is a natural reluctance of the patient to be examined for cancer, especially when it requires surgery to obtain the tissue samples. Fourth, to justify taking a biopsy, a well advanced lesion must be present. This often leads to non-examination of small early cancerous lesions, and results in delayed diagnosis.
It is, therefore, an object of this invention to provide a device and new methods for routine screening of cancer and other diseased states in which tissue changes occur.
It is a further object of this invention to provide such device and methods which will eliminate the necessity of cutting tissue from the patient.
It is another object of this invention to provide a method for obtaining cell samples by the use of which a high percentage of the cells obtained will be arranged on the same plane with the nucleus in the center to facilitate examination and determination of the character of the cells. It is a further object of this invention to provide a hand held device, lacking in bulk, which can be used in confined places on the patient with great accuracy, which may be used to survey an area on the patient, and which may be used at the time of making other routine examinations of the patient to accomplish the testing without being frustrated by the usual reluctance of the patient against being cut to obtain the sample.
It is also an object of this invention to provide a method of cancer detection and treatment which will comprise the earliest detection of cancerous cells, inspection for recurrence without waiting to operate or cut the patient, and continual re-examination without subjecting the patient to surgical trauma.
Another object of this invention is to provide a method and means to obtain cell samples from devices which may ordinarily be used by human beings such as dental plates, pessaries and the like, and also to obtain such samples from other accessible areas of the body such as the throat, stomach, rectum or any cavity in the body, or from a draining fistula, without the necessity of resorting to surgery.
It is a further object of this invention to combine our cell collector with other examining instruments such as laryngoscope, cystoscope, bronchoscope, gastroscope and gynecological specula for obtaining samples from the body cavities accessible to these instruments during regular examination.
We achieve the objects and advantages of this invention with the methods set forth hereinbelow, and also with the device as set forth in the accompanying drawings in which:
FIG. 1 is a medial cross sectional view of the device in disassembled extended position;
FIG. 2 is a plan view of a filter as used in the device;
FIG. 3 is a plan view of a washer as used in the device;
FIG. 4 is a perspective view of a glass slide being engaged by a filter in solid line, the dotted lines being included to show how the filter is wiped across the slide to scrape cell specimens from the filter onto the slide for inspection;
FIG. 5 is a plan view of another form of filter made of a foamed material;
FIG. 6 is a sectional view of FIG. 5 shown along the lines 66 in FIG. 5;
FIG. 7 is a flexible plastic tube broken off in the middle to show indeterminate length;
FIG. 8 is a part diagram part flow chart; and
FIG. 9 is a perspective of a detail of the end of nose portion of the device.
Similar numerals refer to similar parts throughout the several views.
The device 10 of the invention, preferably made of stainless steel or any other suitable material, is a collector nozzle for a suction device, not shown. The type of suction device used is well known in the art, and will usually be found in any fairly well equipped dental office and in many physicians ofiices. There is the usual machinery necessary to create suction similar in principle .to the ordinary vacuum cleaner, and there may be one or more tubular flexible or resilient hoses 11 connected to the suction machinery.
The collector nozzle 10 comprises anose portion 12 and arear portion 13. Thenose portion 12 and therear portion 13 are adapted to be removably fitted to each other by means of male 14 and female 15 threaded areas. Thus, therear portion 13 can be screwed into thenose portion 12. Thenose portion 12 has aninternal passageway 16 which flairs out into a venturi chamber 17 as shown in FIG. 1 of the drawings.
We provide ametallic filter 20 made of a mesh of the size of 10 mu. This particular size has been selected for the type of cells which would ordinarily be found in cancer in the month. However, the size of the mesh can be varied for different types of cells such as blood cells, as well as groups of small inflammatory cells in lesions ranging in size from 2 to 10 mu., thus requiring mesh as small as 2 mu. up to 10 mu. It is possible to have even sizes as small as 2 mu. up to 10 mu. It is possible to have even smaller or larger sizes for special purposes.
Thefilter 20 is placed within thechamber 21 formed in the inner end of thenose portion 12, and over thefilter 20 is placed a washer such as the Teflon washer 22. Then therear portion 13 is screwed into thenose portion 12 by means of threads 14 and 15 untilinner end 24 ofrear portion 13 fits tight against washer 22 to holdfilter 20 in position with its center portion in faced contacting relationship with the end of venturi chamber 17.
Rear portion 13 also has apassageway 25. Thus, when the device is assembled as aforesaid, there will be a con tinuous central passageway betweennozzle entrance 26 andnozzle exit 27 comprisingpassageway 16, venturi chamber 17,filter 20, andpassageway 25. There is anattachment facility 28 located at or nearnozzle exit 27 which is adapted to fit into hose 11 to effect connection betweenpassageway 25,nozzle exit 27 and theinside passageway 30 of hose 11. Thus, when suction is applied to hose 11, it will draw throughpassageway 30 and through the entire apparatus as above described so that any matter at or nearnozzle entrance 26 which will be sufliciently small to enterpassageway 16 will be drawn into the device and pulled against theface 31 offilter 20. Air, liquid and some of the material may pass throughfilter 20, but the cells desired to be inspected will remain on theface 31 of thefilter 20.
While we have describedelement 28 as an attachment facility, it is intended to represent any type of standard coupling arrangement which may be used in conjunction with the usual types of suction devices well known in the art in order to attach nozzles or other tools to the devices.
The outer end ofnose portion 12 in the vicinity ofnozzle entrance 26 is abraided or roughened, as indicated by the dotted area at reference numeral 26a in FIG. 9 of the drawings, so that it will be made blunt. This is for the purpose of enabling the operator to scrape specimens from tissue on a living person or animal. This not only facilitates obtaining the specimens of cells, but also tends to prevent injury to the patient by insuring that the nozzle entrance will not have a sharp cutting edge.
It is now apparent that the methods as well as the device used operates on the principle of a vacuum cleaner and, therefore, eliminates the necessity of surgery in order to obtain cell specimens from the patient. Thenozzle entrance 26 may be applied to any accessible portion of the body of the patient and to any cavity of the body of the patient. If it is desired to obtain specimens from the throat, stomach, rectum or any other similar cavity, this may be done by means of applying a flexible plastic tube, such astube 35, tonozzle entrance 26 by fitttingend 36 ofnozzle entrance 26 and usingend 37 as the auxiliary nozzle entrance. This plastic tube may then be inserted into the patients body cavity in any manner now known to the medical arts to obtain a specimen. The plastic tube is shown herein by way of example, and any other type of tube or device which is flexible or resilient or deformable may be used for this purpose, and it may be connected to the collector nozzle in any manner known to the art.
We have found that the methods and device described herein are particularly useful for the detection of cancer in the mouth of a patient, and specimens may not only be taken from the patients mouth, but also from dental plates or other prosthetic devices by running thenozzle entrance 26 over and in contact with the mouth, dental plates or other devices to collect cells by suction means. In this manner, mouth cells and even some tissue can be pulled off without damaging the remaining tissue, and Without worrying or annoying the patient, as a routine procedure during a dental examination. Thus, clinical inspection of these cell samples may possibly reveal cancer even before the patient has symptoms. This, of course, is highly desirable since early detection is the most important factor in cancer cure today.
In addition, the device used is so constituted that the cells which are pulled off are collected on the filter, or collecting means 20, without damaging the cells. This is partly due to the fact that the collection method involves vacuum suction rather than mechanical scraping or cutting, and mainly due to the effect of the venturi chamber 17, The venturi configuration of chamber 17 results in the cells being deposited on the filter, or collecting means 20, at a greatly reduced pressure then the pressure used to pick up the cells atnozzle entrance 26. Thus, chances of injuring the cells are greatly reduced.
Another advantage of the suction collection system and apparatus described herein is that When a friable lesion may break off from the patient, cells may be collected therefrom thousands at a time and sectioned and selected and analyzed. These cells would otherwise be lost to the clinician.
In addition, cells may be collected from a draining fistula or any cavity where fluids can be sucked into theregular nose portion 16 or theflexible tube 35 which may 'be made of polyethelene or any other suitable material.
One of the main advantages of the methods and device described herein is that by means of the suction, it will pull and collect cells from the patient which have not already fallen off, and will be more representative of the actual condition of the patient. We also find that with the use of this device and method, the cells collected will be fiat on the filter, or collecting means 20. The advantage of this is that inspection of the cells in a single plane, with nucleus in the center, will lead to quicker and more certain recognition of the character of the cells involved.
In an alternate form of the invention, we may provide filters, or collecting means, made of sponge or gelatin fibran or gel foam and/ or cellulose meshes. Such a filter is represented by reference numeral 40 in FIGS. 5 and 6 of the drawings. When using a metallic filter, such as mesh filter or collecting means 20, theface 31 of thefilter 20 is scraped onto a glass slide 41 as shown in FIG. 4 of the drawings so that the cells will be placed on an inspection means such as a microscope or other slide 41. This is usually best accomplished by scraping the collecting means 20 againstedge 42 of the slide, and then spreading the specimen in a thin film on the flat surface of the slide as is known in the medical arts for preparing blood smears, and then permitting it to air dry, and then staining the specimen so that it can be inspected under a microscope or by any other means to determine the character of the cells. No fixation by chemical or other means is required to preserve the specimen. Thus, this is an additional advantage over present methods, all of which require chemical fixation. This is so because we provide a specimen in a thin film of cells, readily air dryed and which remain intact in the dried state and still retain typical characteristics for recognition. We eliminate all need for the expense and technical problems of chemical fixation, and shipping slides immersed in chemical containers to the laboratory for examination. The specimen so obtained by our cell collector may be shipped dry without preservative.
When using a cellulose or gelatinous filter, the filter would be placed face down on a glass slide, and the material of the filter would be dissolved with ethyl acetate or some similar substance leaving the specimens in center of the slide smeared asa film as described above. These would then be stained for inspection.
By using our methods and device, we could even have an immediate inspection of the specimen material without staining by inspecting the material under a phase contrast microscope. This is a tremendous advantage since the pathologist can determine Whether cells are benign or malignant almost immediately during major surgery.
Perhaps the greatest advantage of our system is that We may survey an area. For example, where there is a white patch on the patient, it may be that cancerous cells are irregularly located on or within the patch. A surgical sample taken from the patch is limited to the area cut out which might not contain cancerous cells, although close to them, and thus the test would prove negative, and consequently false. With our method and device, We could suck cells from a large area of the surface of the patch, concentrating them together on the small filter area, thereby subjecting a vastly greater tissue sample to examination without cutting the patient, and pick up cancerous cells which would otherwise be missed.
Another significant advantage of the device We describe for collecting cells is that blood, pus, pigments, food fragments and other foreign material and debris can be removed from the sample by washing by means of drawing water through thenozzle entrance 26 without disturbing the cells collected on the face of the filter or collecting means 20 or 40 as the case may be. In addition, cells can be fixed, if desired, while on the face of the filter or collecting means by drawing alcohol, formalin, Buins solution and/or vital dyes through the system. As described above, however, fixation is not necessary with our invention but may be employed for special types of strainmg.
A method of collecting cytological specimens is illustrated in the flow diagram shown in FIG. 8 of the drawings. In this illustration of the method, oral cytological specimens are collected from the mouth of the patient.
The patient is seated in a suitable examination chair such as a dental, E.N.T. or surgical examination chair, in a strong light which will illuminate all of the surfaces of the mouth. The patient is asked to rinse his mouth with tap water in order to wash out gross food particles, as illustrated by the box marked A.
The oral tissues are retracted and the area to be examined brought into view. The cell collector, having been previously attached to adequate suction means, is held in the hand like a pen and the needle end is vigorously scraped over the surface of the suspected area of the mouth. After several passes, the needle is dipped into water so that the cells adherent to the sides of the needle are washed onto the screen contained in the vacuum chamber. The lesion is thus repeatedly and vigorously scraped and intermittent water washing is done. This is Step B.
After the entire lesion has been surveyed in this manner, the patient may be discharged. The operator then detaches the suction and opens the vacuum chamber. By means of a small forceps, the screen may be removed and scraped and smeared over the surface of a chemically cleaned glass microscope slide. This is Step C.
The specimen is then allowed to air dry (Step D) and is placed into a cardboard mailer (Step E) and sent to the laboratory accompanied by the clinical description of the lesion and the patients history (Step F). At the laboratory the slide is stained and examined by the pathologist in the usual accepted manner (Step G). Their diagnosis is made (Step H), advice is given to patient and/ or treatment is given, if required. (Step I.)
We have, therefore, described herein a method for collecting cells for inspection which comprises the steps of providing a nozzle containing a filter or collecting means, sucking material from a patient into the nozzle and through the filter, then removing the specimens obtained on the face of the filter or cell collector to a glass slide, treating the material on the glass slide for inspection, and inspecting the material to determine the character of the cells collected. The inspection step may usually be accomplished by means of a microscope or other instrument to enable the viewer to see the character of the cells collected.
The method set forth hereinabove may, of course, be varied to suit the situation as well as the type of examination to be made. The important step in the method is the step of removing the material to be analyzed by means of the vacuum or suction principle rather than by surgery or other means.
While we have described our invention in this preferred form, there may be other forms in which it may be practiced and other devices for accomplishing same, and we, therefore, desire to be protected for all forms coming within the claims hereinbelow.
Wherefore we claim:
1. A clinical cell collector, comprising a nozzle having a nose portion and a rear portion, said nose portion and said rear portion being detachably connectible to each other, a longitudinal passageway in said nose portion and a longitudinal passageway in said rear portion, said passageways providing a through passageway when the two portions are connected, the passageway at the end of the nose portion adjacent the rear portion being enlarged to form an annular chamber, and a cell-collecting filter seated in said chamber so as to be athwart the longitudinal passageway, whereby when suction is applied to the far end of the rear portion the filter will be in the path of cells that are aspirated by the nose portion, the end of the nose portion remote from the rear portion being roughened so as to serve as a scraper of cells.
2. The clinical cell collector as defined in claim 1 in which the said cell collecting filter is made of a metal mesh material.
3. The clinical cell collector as defined in claim 1 in which the said cell collecting filter is made of a cellulose material.
4. The clinical cell collector as defined in claim 1 in which the said cell collecting filter is made of a gelatinous material.
References Cited by the Examiner UNITED STATES PATENTS 1,583,023 5/ 1926 Stoloif 32--33 2,276,841 3/ 1942 Hanson 73--61 2,701,559 2/ 1955 Cooper 1282 2,857,913 10/1958 Miskel 128-221 2,905,169 9/ 1959 Nieburgs 128-2 3,003,496 10/ 1961 Klein 128-2 FOREIGN PATENTS 1,165,406 6/ 1958 France.
RICHARD A. GAUDET, Primary Examiner.
JORDAN FRANKLIN, LOUIS R. PRINCE, Examiners.