US 3929133 A
An apparatus useful in pregnancy termination utilizes vacuum aspiration to remove the products of conception and transfers such products to a transparent container which is located proximate the patient and in which the larger products of interest are separated out, are washed and are visibly displayed for immediate examination as the operation proceeds.
Description (OCR text may contain errors)
United States Patent [1 1 Ragab 1451 Dec. 30, 1975 1 1 APPARATUS FOR REMOVING, WASHING AND DISPLAYING FRAGMENTARY PRODUCTS OF OPERATIVE PROCEDURES  Inventor: Mohamed Ismail Ragab, Cairo,
 Assignee: International Pregnancy Advisory Services, Chapel Hill, NC.
 Filed: Nov. 20, 1974  Appl No.: 525,512
 US. Cl. 128/277  Int. Cl. A61M H00  Field of Search 128/277, 276, 278, 275,
 References Cited UNlTED STATES PATENTS Flatray 128/277 3,680,560 8/1972 Pannier et a1 128/276 3,774,613 11/1973 Woods, Jr. et a1... 128/277 X 3,782,384 1/1974 Timmermans 128/277 3,785,380 1/1974 Brumfield 128/276 3,863,624 2/1975 Gram 128/276 X Primary Examiner-Richard A. Gaudet Assistant Examiner,l. Yasko Attorney, Agent, or FirmB. 3 Olive  ABSTRACT An apparatus useful in pregnancy termination utilizes vacuum aspiration to remove the products of conception and transfers such products to a transparent container which is located proximate the patient and in which the larger products of interest are separated out, are washed and are visibly displayed for immediate examination as the operation proceeds.
11 Claims, 6 Drawing Figures VACUUM SOU RC E 40 FOOT E CONTROL MUKDOW ZDDU APPARATUS FOR REMOVING, WASHING AND DISPLAYING FRAGMENTARY PRODUCTS OF OPERATIVE PROCEDURES BACKGROUND OF THE INVENTION 1. Field of the Invention The invention relates generally to medical apparatus and to evacuation apparatus for withdrawing fluids and dislodged products in operative procedures and more specifically to uterine evacuation apparatus.
2. Description of the Prior Art Uterine evacuation using vacuum aspiration is becoming the preferred method for first trimester abortions, as well as an excellent way of treating incomplete abortions. The volume of material removed varies from 50 to 200 ml. and consists of blood, liquor amnii, and the products of conception. The assessment of material removed at operation helps determine the immediate and post-operative treatment of incomplete abortion. In the case of termination of pregnancy, it is essential for the operating surgeon to be able to inspect the products of conception, to exclude the possibility of extrauterine pregnancy, diagnose pathological conditions (such as hydatidiform mole) and to check the preoperative diagnosis of the length of pregnancy by recognition of the developmental stage of the embryonic fragments. This use of operative disclosure of products of conception. to refine diagnostic skills is important for all but the most experienced. If the products of conception are washed and separated on a surface for display, then naked eye inspection is sufficient for virtually all purposes.
The prior art practices have used uterine evacuation techniques in which the products of conception and in other cases menstrual fluids, as in US. Pat. No. 3,828,781, have been withdrawn through an appropriate cannula by use of vacuum. In the case of pregnancy terminating operations, the withdrawn products are normally taken to a separate site, remote from the site of operation, where they are selectively separated, washedand examined. Much time is lost in this procedure since the conventional apparatus does not provide any means for separating, washing and examining the products of interest at the site of operation and during the course of operation.
In connection with outpatient screening for endometrial cancer, there is now being marketed a uterine evacuation apparatus identified as the Vabra aspirator. This is being sold by Cooper Laboratories, Inc., Wayne, New Jersey 07470. The Vabra apparatus collects the cancer related aspirate in a chamber which is filled with a fine mesh. The desired specimens are retained on the mesh and transported to the pathologist for subsequent processing and examination. While the Vabra evacuation apparatus does provide means for separating and collecting operative products of selected size it makes no provision for washing the products at the site of operation or for retaining them in a manner in which they can be visually examined at the site of operation and during the course of operation. It is this latter need that has become particularly urgent in pregnancy termination procedures because of the rapidly increasing volume of such operations.
SUMMARY OF THE INVENTION The surgical equipment of the invention separates the products of conception from liquor amnii and blood, washes and collects the tissue. Unlike previous collecting systems, tissue is drawn into a transparent container and adheres, by a process of filtration to the outside of a transparent, cylindrical sieve, where it is easily seen, rather than being accumulated inside a container as a matted ball of tissue, as in prior art equipment, which makes the tissue impossible to inspect directly and which requires further flotation to spread out the material for inspection. Since with the invention equipment only the products of conception are collected, a small vessel'can be used for all first trimester pregnancies and the operator has the unique and important advantage of being able to visually monitor the progress of the operation. The collection apparatus in which the products are initially washed, then filtered and collected is connected by short flexible tubes to the cannula, a water bottle, and a fluid reservoir all of which can be located immediately adjacent the patient. The water bottle provides the washing fluid and the reservoir collects such products as are not retained on the sieve. The reservoir can be connected by a long tube to the vacuum source which is preferably placed in an adjoining room away from the patient to relieve the woman, if conscious, of the unpleasantness of hearing the pump in action. The operator may turn the suction machine on and off with a foot pedal. The equipment can also be used successfully with both vented and non-vented metal and plastic cannulae and with hand as well as electric suction machines. It may be designed to take any diameter cannula ranging up to eg 12 mm.
DESCRIPTION OF THE DRAWINGS FIG. 1 is an elevation view illustrating the apparatus of the invention.
FIG. 2 is an enlarged view of the transparent assembly in which the washing, filtering and collecting procedures are performed.
FIG. 3 is a bottom view of the stopper without any of the tubes.
FIG. 4 is a top view of the stopper without any of the tubes.
FIG. 5 is a vertical cross section taken through the stopper in the direction of line 5-5 of FIG. 4 and showing portions of the tubes.
FIG. 6 is an elevation exploded view of the sieve.
DESCRIPTION OF THE PREFERRED EMBODIMENT The apparatus of the invention includes a cannula 10, the collection assembly 11, the water bottle 12, the fluid reservoir 13 and vacuum source 14. A tubular connection 20 consisting of a flexible tube 21 and a rigid tube 22 connects between cannula 10 and stopper 23 thereby providing a path for the conception products to be withdrawn from the uterus 15 to the inverted, transparent bell shaped container 16 having a support ring 17 which enables container 16 to be supported immediately adjacent the operative site. The imperforate container 16 has been made of glass but may be made of any suitable thin wall, transparent material and may be otherwise formed compatible with the functions described. An average inner diameter of approximately 33 mm. and approximate internal length of M6 mm. has been found suitable with a wall thickness of about 3 mm. Another tubular connection 25 consisting of flexible tube 26 and rigid tube 27 connects at one end to the water bottle 12 and extends 3 through its stopper 28 to the bottom of the bottle. At the opposite end of connection 25, tube 26 makes connection with a vented stopper 23 thus providing a path for water to be drawn from bottle 12 to container 16 at the same time the conception products are being drawn into the container 16.
To continue the description, an additional connection made up of rigid tube 31 and flexible tube 32 connects between stopper 23 and fluid reservoir 13 and thereby provides a path for those products which are not retained in container 16 to collect in reservoir 13. Another connecting tube 35 connects the vacuum source 14 to the fluid reservoir 13 enabling vacuum to be applied to the reservoir for purposes of operating the system during an operation. Tube 35 may be of an appropriate length but in a preferred form vacuum source 14 is a vacuum pump located remote from the patient but with a foot control located near the site of operation. As will be appreciated from further description, where power is not available, vacuum source 14 could comprise a manual vacuum producing syringe or the like and in such event tube 35 would be relatively short and vacuum source 14 would actually be located near the site of operation. Also, in order to adapt to whatever vacuum is available and to give a greater degree of control over the use of vacuum, a control vent 41 may be provided in cannula 10 to give immediate control at the site and suitable graduated pinch cocks 42, 43 may be installed as illustrated.
Within container 16 there is provided a transparent perforate sieve or wall structure which forms a chamber made up of two upper and lower thimble or cup shaped sections 51, 52 each of which is perforated with numerous holes 53 of uniform diameter and which inter-connect in a cylindrical sieve 50. This arrangement allows the two thimble or cup-like sections to be easily separated for cleaning, sterilization and reuse. Sieve 50 may vary in exact size but in an actual embodiment was approximately 124 mm. in length and 20 mm. in average internal diameter and was formed of a transparent thin, approximately 8 mm. thick, plastic material. Upper section 51 has a closed end 54 and lower section 52 has a closed end 55 provided with a hole 55a into which tube 31 extends as illustrated so as to terminate within sieve 50 but well above stopper 23 as later explained. Sieve 50 could of course be formed as an integral disposable structure. Tube 31, mounted off center in stopper 23, is tilted off vertical as illustrated which causes sieve 50 to be tilted within container 16 and which provides a catchment area as indicated in FIGS. 1 and 2.
In a specific embodiment, there were 185 holes 53 of 4 mm. diameter, spaced 4 mm. apart. The spacing may be less but a substantially large number of holes is preferred. Connection 30 had a 6 mm. inside diameter and a length of 30 cm. Reservoir 13 was a 500 cc. bottle and was graduated from bottom to top in milliliters as illustrated in FIG. 1. Tube 31 extended 50.8 mm. inside sieve 50. Connection 20 was 30 cm. long and had a 12 mm. inside diameter. Connection 25 was also 30 cm. long, was of 1.5 mm. inside diameter but within container 16 had a restricted opening, indicated at 70 in FIG. 5, of 0.2 mm. inside diameter and which allowed about 50 cc. of water per minute to be admitted when suction was applied. Also, it has been found that with they size opening indicated the water is sprayed into the catchment area 60 like a jet stream which continually agitates and washes both the incom-' 4 ing and collected tissue. If the opening is too large excess water is consumed, container 16 fills with water and makes the equipment inoperable.
There are other practical factors that have been noted and found useful to the invention. Tube 21 which connects to cannula 10 should preferably be of a maximum inside diameter of 10 mm. and of a standard size adapted to fit over the usual cannulae of 8, 10, and 12 mm. inside diameter. Wherever tube 21 is required to be formed with a bend as in FIG. 1 this bend should be formed so as to maintain the inside diameter within the tube to facilitate minimum obstruction. Tube 22 is preferably provided with a lip 22' and tube 27 is provided with a lip 27' as shown in FIG. 5 to prevent slippage from stopper 23. Stopper 23 may be formed of rubber or similar resilient material and container 16 is preferably frosted or otherwise given a frictional surface at its mouth to assist in retaining stopper 23.
Tube 31 should preferably have a minimum inside diameter of 5 mm. so as to readily pass those particles having 4 mm. as a maximum outside dimension and which go through holes 53 of sieve 50. A 6 mm. inside diameter for tube 31 is preferred and tube 31 preferably extends into sieve 50 for approximately one-third of its height. This arrangement allows some water to collect in container 16 below the end of tube 31 so as to wash the tissue in such area and prevent formation of blood clots.
Stopper 23 is preferably formed so as to provide a cavity 75, indicated in FIG. 5, immediately below the resting sieve 50. This cavity provides a void in which the collected tissues assemble and are agitated prior to being either washed and carried away through holes 53 or being collected on the outer surface of holes 53. While tubes 22, 27, and 31 and stopper 23 are illustrated as being separate components it is contemplated that all of these could be suitably molded as a single structure. Those surfaces of the apparatus, i.e. tubes, stopper, sieve, etc., which contact the products should preferably be siliconized or otherwise treated to prevent adherence of the products to such surfaces.
The collection apparatus is cleaned in a sterilizing solution, such as cetavelon. After the patient has been prepared for the operation, the collection apparatus may be attached to a leg stirrup so as to be in close proximity to both the operator and field of operation. The assistant connects tube 26 to the water bottle and tube 32 to the fluid reservoir 13. Tube 21 is connected to a pre-sterilized cannula 10 and the vacuum source 14 is switched on. Products of conceptions pass from the cannula 10, together with water from the bottle 12 into the transparent container 16 where they collect and are immediately washed clean. The water rises only to the height of tube 31 within sieve 50 and those particles in excess of the size of holes 53 are retained. Blood, water and liquor amnii are sucked through sieve 50 into tube 32 into fluid reservoir 13 between the collection apparatus 11 and the vacuum source 14. If the source of vacuum should fail for any reason, water does not pass from the collection apparatus to the field of operation. On completion of the operation, the water bottle 12 is refilled, the fluid reservoir 13 is emptied and new clean collection apparatus 11 is prepared for the next case. The collection apparatus may be reused. The sieve may be easily cleaned with a brush.
Because the milliliter markings on the water bottle 12 are graduated downward, visual reading the number of milliliters at the water line gives the operator the procedure. Conversely, because 'thefmilliliter'markings on the fluid reservoir 13 are graduated upward; the
fluid level reading in reservoir 13 gives the total fluid collected during the procedure. Subtraction of the former number from the total fluid accumulated in the fluid reservoir 13 gives the exact amount of blood loss.
ln dealing with incomplete abortion, however, these figures are not subtracted. A minimal amount of water is used in this procedure. The amount of water drawn into the collection apparatus is controlled in three ways. First, the opening from the tube into the collection apparatus is very small. Second, because the operator controls the suction source I4, the vacuum is created only after the cannula is inside-the'uterus l5; and third, only minimum vacuum' pressure is needed to perform the operation. When the desired vacuum level has been achieved, the operatormay'switch off the suction source. The usual vacuum system will retain enough vacuum pressure to allow him to complete the operation.
What is particularly unique about the system and procedure of the invention is that those conception products of particular interest and which have been found to normally be non-liquid and in excess of 4 mm. in their greatest dimension can be collected, washed, filtered out and collected on the. outer surface of sieve 50 for immediate visual examination. Thus, the development stage of the embryonic fragments may be quickly determined and other observations made as previously stated at the outset of this description. The many advantages in time saving, cost and aid to the patient and physician are immediately apparent.
While particularly useful for pregnancy termination, it can also be seen that any similar operative procedure requiring removal of operative products and subsequent washing, filtration, and retentionv of selected products for immediate visual examinationmay utilize the invention with great advantage. The body" may of course be human or animal and the purpose may be diagnostic as well as for research. In whatever event the ability to separate liquid and non-liquid operative products and display them for immediate visual examination offers opportunities not heretofore afforded by any prior apparatus using the vacuum evacuation technique. In some instances, the water", i.e., the washing agent, may be a fluid other than water because of the nature of the products involved and of course the particular type sieve will vary according to the application. Also, it is contemplated that where immediate or continuing visual examination is not important the need for transparency is lessened. The particular shape and size of internal filter chamber or sieve may also vary from the thimble-shaped filter chamber described because of the varying nature of body products with which the invention might be useful.
What is deemed important is that the perforate filter barrier provided by sieve 50 be so formed and arranged within the transparent collection chamber, i.e., chamber 16, such that an inner space within container 16 and which communicates only with the product exit port, i.e., the internal end opening of tube 31, is physically separated from the remainder of the space within container 16 which communicates with the other ports. This arrangement insures that any product flow between entrance and exit ports must go through sieve 50 and also insures that all of the incoming products will be subjected to the washing operation.
1'. In a system for removing from the uterus intermixed liquid andnon-liquid productsof apregnancy preparatory toexternal examination of selected removed non-liquid products, comprising in combinat on; I
a. anaspiration cannula sized to permit insertion into the uterus; v 1 b. an aspirate collection chamber adapted to be supported proximate the uterus and having: 1. an outer imperforate transparent wall structure providing an enclosed collection space with a first entrance port having a tubular connection to the cannula for receiving the products, a second entrance port for admitting water to the chamber in a predetermined pattern to wash the products received therein and a third exit port for discharging the products; and 2. filter means comprising a perforate wall structure having plural holes of uniform size formed therein, said -filter means being mounted within the collection chamber and being formed and arranged so as to isolate an inner space within the collectionchamber which communicates only with said third exit port from the remainder of the space therein communicating with the said "entrance ports such that any product flowbetween the entrance and exit ports is directed through said holes; and a c. vented container of water'having a tubular connection to said second entrance port, whereby with an appropriate level of vacuum applied to the exit port and the cannula in the uterus, the intermixed products along with water are drawn through the respective entrance ports into the collection chamber but externally of the isolated inner space followed by the liquid and non-liquid products of less size thansaid hole diameter being drawn through said perforate structure into such inner space and through the exit port towards the source of such vacuum leaving the filtered out products on display on said perforate wall structure for immediate visual examination.
2. A system as claimed in claim 1 including a second container having a first tubular connection to the exit port to receive the products passed by the holes and a second tubular connection to an appropriate source of vacuum.
3. A system as claimed in claim 1 wherein the collection chamber is formed as a transparent bell chamber with an open lower end and a stopper secured in the open end, the first entrance port comprises the open end of a tube extending through the stopper and connected to the cannula, the second entrance port comprises the open end of a tube extending through the stopper and connected to the water container and of sufficiently reduced diameter with respect to the level of vacuum to spray the water in a predetermined pattern within the collection chamber, the exit port comprises the open end of another tube extending a predetermined distance into such inner space within the collection chamber, and wherein the perforate wall structure forms a closed elongated, tilted off vertical chamber mounted within the collection chamber above the entrance ports and surrounding such inner space.
4. A system as claimed in claim 3 wherein the stopper and the tubes providing said ports are formed as an integral structure.
5. A system as claimed in claim 1 including operator means for controlling the level of vacuum applied to the cannula.
6. A system as claimed in claim 1 including a second container having a first tubular connection to the exit port to receive the products filtered by the holes and having a second tubular connection to an appropriate source of vacuum, the collection chamber being formed as a transparent bell chamber with an open lower end and a stopper secured in the open end, the first entrance port comprising the open end of a tube extending through the stopper and connected to the cannula, the second entrance port comprising the open end of a tubeextending through the stopper and connected to the water container and of sufficiently reduced diameter with respect to the level of vacuum to spray the water in a predetermined pattern within the collection chamber, the exit port comprising the open end of another tube extending a predetermined distance into such inner space within the collection chamber, and wherein the perforate wall structure forms a closed, elongated, tilted off vertical chamber mounted within the collection chamber above said entrance ports surrounding such inner space and including operator means for controlling the level of vacuum applied to the cannula.
7. A system as claimed in claim 1 wherein said perforate wall structure is formed of a transparent material.
8. A system as claimed in claim 6 wherein said perforate wall structure is formed of a transparent material and said holes are circular.
9. A system as claimed in claim 7 wherein said perforate wall structure comprises two thimble-shaped receptacles adapted to be connected to form said filter means as a closed chamber.
10. A system as claimed in claim 6 wherein the water container is transparent and includes measuring volume indicia on the wall thereof scaled downwardly and the second container is transparent and includes measuring volume indicia on'the wall thereof scaled upwardly whereby by visual inspection and subtracting a measured reading of the former from a measured reading of the latter, the volume of said withdrawn products may be ascertained.
l 1. An aspirate collection chamber for operative procedures in which intermixed liquid and non-liquid products, such as products of conception, are removed from the body for the purpose of examining those nonliquid products above a selected size, comprising:
a. a closed vertical tubular-shaped outer chamber formed of a transparent imperforate wall structure providing an enclosed collection space with a first entrance port in the bottom end thereof with associated means for making a tubular connection to the site within the body from which the intermixed products are to be withdrawn, a second entrance port in the bottom end thereof with associated means for making a tubular connection to a vented container of water, and a third exit port with associated means for making a tubular connection to a source of vacuum; and
b. a closed tubular-shaped inner chamber formed of a transparent perforate wall structure having plural circular holes of uniform diameter formed therein, said inner chamber being positioned and occupying a portion of the whole space within the outer chamber and surrounding a lesser inner space communicating only with the exit port, whereby with an appropriate level of vacuum applied to the exit port, with the first entrance port connected to the operative site having the intermixed products to be withdrawn, and with the second entrance port connected to a vented source of water, such intermixed products may be drawn into the outer chamber and around the inner chamber washed with the water and those liquid and non-liquid products sufficiently small to pass through the holes may be withdrawn through the exit port to leave the remaining non-liquid products exposed for visual examination on said inner chamber.