US 3115138 A
Description (OCR text may contain errors)
D 24, 1963 R. T. Mcr-:LvENNY ETAL 3,115,138
EVACUATOR 2 Sheets-Sheet 1 Filed July 14, 1960 Dec- 24, 1963 R. T. MCELVENNY ETAL 3,115,138
EVACUATOR 2 Sheets-Sheet 2 Filed July 14. 1960 5. mwen/y. @Zw 2 ,mm/WV 3 WW/m, m ,J0 m
United States Patent Oiice Patented Dec. 24, 'i963 3,ll5,33 EVACUATR Robert T. Melllvenny, @titl N. Michigan llvd., Chicago,
ill.; Harold l. Snyder, M353 th Si. NVJ., New Philadelphia, Gillo; and Gregory B. Sullivan, 2239 W. lll/ith St., Blue island, lll.; said Sullivan assigner of one-third to said Mclvenny Filed lluly 14, 1960, Ser. No. 42,889 lf2- Claims. (Cl. E28-78) The invention relates to evacuators and more particularly to surgical evaouators lfor the removal of fluid from the human tbody and the like. rPhe present invention has among its objects the production of an evacuator structure -for use in the evacuation of fluids from the human body which is capable of handling l5() cc. or more fluid and which is capable of producing a negative pressure or suction equal to -a column of water of 26 mm. or more in height, rendering the service extremely eilective for the purposes intended.
Another object o-f the invention is the production of an evacuator stnucture which eliminates the need for electrical or mechanical pumps or the like, and which is very simple in construction and relatively inexpensive to manufacture, whereby the device may be packaged in sterile form with all necessary accessories `such as tubing, needles, mounting elements and the like, whereby the item may be stocked and used as a one-time operation, and subsequently discarded.
A further object of the invention is the production of an evacuator having the above features which is relatively unbreakable, foolproof, and provided with all necessary means to permit its attachment to the body of the user, thereby eliminating any possibility of a .failure of operation as a result of disengagement of the tube or the like which might otherwise result from movement of the patient or other reasons, and permitting it to be readily employed for use on ambulatory patients and the like.
Many other objects tand advantages of the present invention will be obvious to those skilled in the art `from the disclosure herein given.
In the drawings, wherein like reference characters indicate like or corresponding parts:
FIG. l is a -front view of a portion of a human body illustrating the application of the present invention thereto in la radical breast dissection or breast removal;
FIG. 2 is a front view of a portion of a human let,lr illustrating the application of the present invention to an operation on a broken tibia;
Y r FrG. 3 1s a View similar to FIG. 2 following completion and 4suture of the 'wound illustrated in FlG. 2;
FIG. 4 is a plan view of the evaouator unit illustrated in FIG. l;
FIG. 5 is a sectional View taken :approximately on the line 5 5 of FIG. 4;
FIG. 6 is -an enlarged sectional view, similar to HG. 5, of a portion of the structure illustrated in FIG. 5, illustrating the evacuattor unit in a collapsed `or operative position;
FIG. 7 lis an enlarged figure of a portion of the tubing employed, with portions thereof shown in cross section and illustrating the engagement therewith of the needle used in installing the tubing in a Wound or the like; and
FIG. 8 is a plan view, with portions in sections, of la Y connector member by means or which two evacuating tubes may be connected to a single evacuator unit.
The present invention contemplates the use of a very simple container structure which readily adapts itself for manufacture out of plastic or other material and which is so designed that upon a partial collapsing, adapted to be readily performed manually, the container will :tend to resume its original shape, creating a negative pressure or partial vacuum there-in, so that by the use of suitable tubing the container interior may be operatively connected with the interior of a wound or the like, operative to Vdraw uids from the latter into the container under the action of the reduced pressure therein. Suitable means may be readily provided, enabling reestablishment of the reduced pressure following depletion thereof as fluids are Awithdrawn from the wound into the container. The evacuator unit may be so designed that it may be strapped or otherwise applied to the body of the user to insure that it will be maintained at all times in operative position, 'and at the same time permitting the patient to be ambulatory.
Typical applications of the prese-nt invention in the surgical field, for example, and not by Way of limitation,
(l) In large surgical fields developed in operations such as radical breast and neck dissections, abdominal, perineal and certain chest procedures.
(2) ln evacuating hematoma in such operations as upon the iup, femur, tibia, forearm `or hand.
(3) To evacuate joint iluid following knee joint operations and the like.
(4) Compound fractures.
(5) The treatment of large soft tissue abscesses and the like.
(6) ln the treatment of Ichronic osteomyelitis, septic joints and the like,
(7) Other uses, as for example, the replacement of catheters now employed in many situations.
The use of drains in wounds is quite common, ordinary operative `wou-nds normally being drained for a period of iorty-eight hours after the operation. Extensive procedures or operations such as hip reconstnuctio-ns arid -femural shaft procedures yield three hundred to eight hundred cc. of blood and serum during the first forty hours. The next eight hours normally shows a diminishing return until near the end of the Iforty-eight hour period little if any material is recovered, following which the drains or tubes may be removed. The use of ellective measures to withdraw such fluids results in a number of improve-d conditions. Swelling is kept at a minimum and suture tension is markedly decreased, with noticeably less post operative pain, and :the wound edges lare kept White, flat and quiescent.
The elimination of hem-atome, swelling :and tension also eliminates some encouraging factors for infection.
The tubing employed inside the body is constructed of plastic or other material which is non-reactive to the body constituents and is constructed with Walls which are rigid las distinguished from collapsible, the tube being of a size to accommodate the iiuids as they accumulate and, as hereinafter described in detail, we have 4found that fa tubing which will fit a sixteen gauge needle, is very satisfactory for the purposes intended.
In use, a portion of the tubing, usually a free end thereof in the case of single tubes, may be suitably insorted in the wound as hereinafter `described in detail, following which it is operatively connected to the evacuator container unit which is suitably manually actuated to create a negative pressure within the container whereby tluids will be drawn from the wound into the container. Straps or `other suitable means may be provided to permit the securement of the evacuator container or unit to the body of the user or patient.
Referring to the drawings and more particularly to FlG. l, the reference numeral l indicates generally an evacuator container or unit, the interior of which is adapted to be placed under a reduced or negative pressure compared with that of the exterior. the application of the invention to a breast operation, a
in the illustration which showsV pair of tubes 2 are inserted in the wound and operatively connected to the container ll by a connecting or lead-away tube 3 and manifold means formed as a if-shaped connector member Il operative to connect the tube 3 to the tubes 2, with the container unit l being mounted on the lower chest or stomach of the user by suitable means such as a plurality of straps 5, as hereinafter described in greater detail. lt will be noted from a reference to FlG. 1 and as will be apparent from the description of FlGS. 2 and 3 hereinafter given, the tubes within the wound are not brought out through the incision, such as the incision 6 illustrated in FlG. l, but rather a point spaced therefrom whereby the tube passes through healthy tissue and from which the tube, following completion of its intended use, may be readily withdrawn, leaving a small opening which will readily heal.
The Evacuator U nit Referring to FlGS. 4 through 6, the embodiment of the invention illustrated employs an evacuator container or unit l which is constructed of relatively thin flexible or pliable plastic, or other suitable material, the unit Il illustrated comprising a generally circular top wall 7, a generally similarly shaped bottom wall 3 and an annular shaped side wall 9. As illustrated in FIG. 6, the top and bottom walls '7 and 3 are secured to the adjacent edges of the side wall 9 by two seam lines Ill which may be formed as a suitable bond or weld resulting from the application of heat and pressure to the portions to be joined, the free edge portions l2 of the top and bottom members extending beyond the outer weld line, permitting it to fold inwardly as illustrated in lilG. 6.
Mounting flaps i3 may be integrally formed with the bottom wall 8, the flaps as illustrated in FlG. 6 preferably being provided with a reinforcing ring ld of similar material and secured thereto by suitable means such as heat and pressure welding or the like, the llaps thus being provided with an opening l5 through which the mounting straps 5 may be passed.
Positioned within the container are a pair of oppositely disposed members i6 and 17 which, in the construction illustrated, may be identical in shape and size, the members illustrated being circular in shape and having a diameter substantially equal to the inner diameter of the top and bottom walls. The members i6 and E7 are made from relatively rigid material such as a suitable plastic or the like, and may be provided with a suitable means, as for example, a plurality of inturned oppositely disposed cylindrical bosses or shoulders i3, for maintaining respective compression springs Il@ in operative position between the members )i6 and i7, four such springs being employed with each member i6 and i7 having a like number of portions rtl formed therein.
The container may be provided with a suitable fluid outlet, illustrated as being formed by a tubular member 2l, having an outwardly extending tlange 22 thereon which is secured in fluid tight relation to the upper wall 7 by suitable means such as cementing, welding or the like. The outlet member illustrated is aligned with one oi the spring aligning portions liti, top wall 7 being provided with an opening Z3 therein to operatively connect the interior of the container, through the portion 18, with the interior of the outlet member 2l, the latter being releaseably closed by a suitable stopper member 24 which may be provided with suitable means, such as a llat relatively thin strip 25, which may be manually grasped to facilitate the insertion or removal of the stopper 24 from the member 2l.
The tube 3, forming the means by which fluid may enter the container l., is suitably secured at its adjacent end to the container, as for example, by providing the tube with an outwardly extending ilange 26 which may be suitably secured to the wall 7, the tube 3, in the construction illustrated, being aligned with one of the spring aligning portions llf and operatively connecting with the interior of the container through an opening 27 formed in the top wall 7 and the interior of the aligned portions ld. lf desired, the strip Z5 associated with the stopper 24 may be provided with an apertured free end 2% aving a hole 29 therein, the strip 2S being of a length to permit the tube 3 to be inserted through the opening 29 so that the stopper 2.4icannot be lost from the unit. Likewise, to insure a firm connection between the stopper and the inlet tube 2l, the latter may be tapered or flared slightly and the stopper complementally formed as disclosed in PEG. 6.
As illustrated in FlG. 7, the tubing 2 which is adapted to be inserted into the wound is constructed from a suitable material which is inert to the body fluids and tissue, the tube being relatively flexible but having a wall thickness which will provide in eilect a rigid tube wall which will adequately resist collapse under the operational conditions involved. We have found that a tube having an internal diameter of approximately one-sixteenth of an inch is adequate for most applications of the invention, the tube having an external diameter or" approximately one-eighth of an inch. As illustrated in FlG. 2, the free end 2n of the tube may be provided with a plurality of apertures 3l, the length of the apertured portions varying as to the particular application in which it is to be employed, with an initial length of eight inches, which if desired may be shortened by cutting off the tube, being sutlicient for most applications. ln the embodiment shown in FlG. 7, the tube is provided with apertures 31 having a diameter ot approximately forty-thousandths ot an inch and axially spaced substantially one-quarter of an inch, the apertures being diametrically positioned on opposite sides of the tubing and conveniently formed by punching or other suitable operation. Thus, pertorations 3l may be readily produced by punching with a member having a diameter of approximately fifty-six thousandths of an inch and following the punching operation the material at the perforations will 'low slightly to reduce the diameter of the pertorations to approximately forty-thousandths oi an inch.
The tubing thus far is of a size which may be readily allixed to a needle, indicated generally by the numeral 32, of a size substantially equal to that of a l6-gauge needle, which is provided with a suitable point 33 at one end and a mounting stem 34 at the opposite end, having external threads 35 thereon. The stem 3ft is connected to the needle body by a neck portion 36 of reduced diameter, whereby the stem may be screwed into the adjacent end 2b of the tubing 2 and aiiixed thereto by the threads 35, the end of the tube extending into the neck portion 36, as illustrated in FlG. 7, whereby the end of the tube will not interfere or engage the ilesh as the needle and tube are drawn therethrough.
Operation of the Device In use, as illustrated in FIG. 2, prior to suturing of the wound W one or more tubes are placed with their perforated ends in the wound, the perforations preferably being positioned at the points where evacuation is desired, the opposite end 2b of the tube being brought through sound tissue as illustrated at 57 and 38, such insertion being accomplished by insertion of the needle 33 and connecting tubing 2 from within the wound outwardly through the healthy tissue. Following the placing of the tube or tubes in the manner illustrated, the wound is closed by suturing in the usual manner. The tube may then be cut adjacent the connection thereof with the needle 33 to sever the latter and provide a clean tube end which may be inserted either into the lead away tube 3, operative to connect the tube 2 with the evacuator unit l, or if two tubes are employed as illustrated in FIGS. 1 or 2, the corresponing ends of the tubes, may be operatively connected to the lead away tube 3 by a suitable manifold means formed as Y-shaped connector l which may be constructed of plastic or other suitable material, the connecting leg 39 thereof having an internal diameter capable or receiving the adjacent end of the lead away tube 3 in a tight tit by means of which the connector i will be firmly attached to the tubing 3. The opposite legs 4t) are provided with end portions of a size to accommodate the smaller tubing 2, adapted to engage the latter in a firm friction grip which will retain the tubing operatively connected under all normal conditions.
If desired, instead of using a pair of tubes as illustrated in FIGS. l and 2, in some conditions a single tube may be satisfactory, such construction being illustrated in FIG. 3 wherein the single tube 2 is provided with a perforated intermediate portion 41 which is adapted to be inserted into the wound, both ends of the tube being brought out of the exterior and operatively connected by suitable means such as a connector 4 to the lead away tubing 3.
Following the operative connection of the tubing 2 and 3, the stopper' 24 may be temporarily removed from the outlet 21 and pressure applied to the top and bottom walls 7 and d, as for example, by manually squeezing the container, to collapse the intermediate wall 9 and move the top and bottom walls toward one another to a position similar to that illustrated in FG. 6. While the walls 7 and S are so positioned, the stopper 24 is reinserted into the outlet 2i and pressure on the container released, whereby the compression springs 19 will urge the members 16 and 17 in opposite directions, thus tending to expand the container to its original shape and size and thereby create a negative pressure or vacuum in the container unit 1, which through the tubing 3 and tube or tubes 2, will tend to draw any accumulated iluids within the wound into the container 1, such action continuing until the container has been lled to a point where the action of the springs 19 is exhausted. At such time the stopper 24 may be removed and any fluids drained from the container, following which the latter may be collapsed as previously described and the stopper reinserted to restore the original conditions.
To facilitate the desired operations, and permit persons, otherwise able, to be ambulatory, straps 5 or other suitable means may be employed to mount the container unit l on the body of the user. Thus in the example illustrated in FlG. l, the unit 1 may be mounted on the lower chest or abdomen of the user by means of the straps 5 which may be passed through the openings )l5 in the straps 13 to position the strap beneath the bottom wall 8, following which the strap may be passed around the body of the user and the free end secured by suitable buckles 42 or tle like. In cases such as illustrated in FIGS. 2 and 3, the container may be strapped about the thigh of the user or otherwise attached, at a suitable location, to the users body.
After the unit has served its purpose, the tubing 2 may be suitably removed from the body of the user, such tubing being withdrawn from the wound in those cases where the free end of the tubing is positioned in the Wound, and in those cases such as illustrated in FIG. 3 the tubing is sterilized and cut adjacent one end of its exit from the body, following which the other end is tensioned to withdraw the tubing.
It will be noted from the above that we have provided an evacuator structure which is very efficient in use, yet suiiciently simple in construction and inexpensive to manufacture to permit its use as a one time operation, whereby each case would employ a new unit, thereby eiiminating cleaning problems, etc. Preferably the device would be packed as a complete kit in a suitable sterile wrapi ing or envelope, each kit containing an adequate supply of tubes and needles, together with the container unit, connectors, mounting straps, etc., whereby each package is seit-contained with all items necessary for the application which is to be made thereof.
Having thus described our invention, it will be obvious to those skilled in the art from the disclosure herein given that various modications may be made in the same without departing from the spirit of our invention; hence we do not wish to be understood as limiting ourselves to the exact form, construction, arrangement and combination of parts herein shown and described, or uses mentioned.
What we claim as new and desire to secure by Letters APatent is:
l. A self-contained, independently operable evacuator structure for the extraction of body fluids, for ambulatory human use, said evacuator structure comprising a iluid tight container formed from flexible material, said container having circular top and bottom walls connected at their peripheral edges by an annular shaped wall, a pair of circular members of approximately the same size as the interior portions of said top and bottom walls and disposed within said container adjacent such walls, al plurality of springs disposed between said members with the opposite ends of each spring engaging the respective members to exert a separating force thereon, oppositely disposed inwardly extending means on said members engageable with said springs to retain the latter in operative position, one of said circular container walls including an inlet tube connected thereto in fluid tight relation, an outlet also provided in the aforesaid container wall, means releasably sealing said outlet, the opposite wall being provided with `a plurality of outwardly extending iaps oonstructed to operatively receive means for maintaining the container on a body, a iluid receiving tube operatively connected in iluid tight relation to said inlet tube, said fluid receiving tube 'being lexible and having relatively non-collapsible side walls, 1a portion which is provided with a plurality of generally radially extending openings therein operatively communicating with the tube exterior, said last mentioned portion being adapted to be inserted into ya wound with said openings forming fluid inlets, said circular members being operative when moved by collapsing of said container to compress said springs, to create a negative pressure in said container to dnaw fluid through said tube into the container.
2. An evacuator structure as defined in claim 1, wherein said duid receiving tube is constructed for manual connection with said inlet tube, and a needle is provided with la point at one end and means at the other end engaging and securing the end of said fluid receiving tube engagcable with said inlet tube for drawing the adjacent end portion of the fiuid receiving ltube through flesh, outwardly from `a Wound to be evacuated.
3. A self-contained, independently operable evacuator structure for the extnaction of body fluids, for ambulatory human use, said evacuator structure comprising a fluid tight container formed from flexible material, said container having top and bottom, yand side walls, a pair of members of approximately `the same size as the interior portions of said top and bottom walls and disposed within said container adjacent such walls, a plurality of springs disposed between said members with the opposite end of each spring engaging the respective members to exert a sepanalting force thereon, one of said container walls including an inlet tube @connected thereto in fluid tight reliation, ran outlet also provided in the aforesaid containerwall, removable means releasably sealing said outlet, a iiuid receiving tube operatively connected in iluid tight relation to said inlet tube, said duid receiving tube being flexible and having relatively non-collapsible side walls, a portion which is provided with ian fopen-ing therein oper-atively communicating with the tube exterior, said last mentioned portion being adapted to be inserted into a wound with said opening forming a duid inlet, said members being operative when moved by collapsing of said container to compress said springs, to create a negative pressure in said container to draw fluid through said tube in-to the conrbainer, Iand rain outwardly extending flap provided Ion one of said walls constructed to operatively receive means for maintaining the container on a body.
4. A self-contained, independently operable, evacuator for the extraction of body iluids, for ambulatory human use, said evacuator comprising in combination, a container formed of flexible material, said container having -a pair of oppositely facing end walls and a connecting side wall arranged for movement of the end walls relatively toward each other to reduce the volume of the container, said container being resiliently compressible when subjected to manual pressure and upon release of said manual pressure being resiliently expansible to a normal expanded position, said container having an opening in one wall thereof, a conduit of ilexible tubing connected at one end to said container opening, the other end of said tubing being of a material compatible with human tissue and being arranged for insertion into a body wound, means forming a part Iof the evacuator and forming an exhaust opening in communication with said container, and closure means for said exhaust opening, whereby upon compression and release of said container with the tubing end inserted into a body wound, and upon closure of said exhaust opening, body fluids will be extracted from the wound by continuous suction upon expansion of the container and expressed into the container for storage therein.
5. An evacuator as defined in claim 4 wherein said other end of said iiexible tubing is provided with a multiplicity of juxtaposed openings for insertion into said body wound.
6. A n evacuator as dened in claim 4 wherein a plurality of springs is provided within the container for effecting the resilient expansion thereof upon release of said manual pressure.
7. An evacuator as dened in claim 4 wherein said container is provided with strap fastening means, and wherein said evacuator further includes a strap member arranged to be secured to said fastening means and -to the body of a human for supporting the container therefrom, whereby to facilitate the ambulatory human use of said evacuator.
8. An evacuator as dened in claim 4 wherein said closure means for said exhaust opening comprises a selectively operable manual valve.
`9. An evacuator as defined in claim 8 wherein said Valve comprises a valve plug insertable into the exhaust opening in the container, and a strap anchored to the containing carrying said plug.
110. A self-contained, independently operable, evacuator for the extraction of body fluids, for ambulatory human use, said evacuator comprising in combination, a container formed of flexible material, said container having a pair of oppositely facing end walls and a connecting side wall arranged for movement of the end walls relatively toward each other to reduce the volume of the container, said container being resiliently conlpressible when subjected to manual pressure and upon release of said manual pressure being resiliently expansible to a normal expanded position, said container having an opening in one wall thereof, a conduit of flexible tubing connected at one end to said container opening, the other end of said tubing being of a material compatible with human tissue and being arranged for insertion into a body wound, a needle removably connectable to said tubing for drawing said other tubing end into said body wound, means forming a part of the evacuator and forming an exhaust opening in communication with said container, and closure means for said exhaust opening,
whereby upon compression and release of said container with the tubing end inserted into a body wound, and upon closure of said exhaust opening, body fluids will be extracted from the wound by continuous suction upon expansion of the container and expressed into the container for storage therein.
1l. An evacuator as defined in claim 10 wherein said needle is sharpened at one end, and is provided at its other end with threads for removable connection to said tubing.
l2. A self-contained, independently operable, evacuator for the extraction of body fluids, for ambulatory human use, said evacuator comprising in combination, a container formed of flexible material, said container having a pair of oppositely facing end walls and a connecting side wall arranged for movement of the end walls relatively toward each other to reduce the volume of the container, said container being resiliently compressible when subjected to manual pressure and upon release of said manual pressure being resiiiently expansible to a normal expanded position, said container having an opening in one wall thereof, a conduit of exible tubing comprising a rst tubing por-tion connected at one end to said container opening, a second tubing portion of a material compatible with human tissue arranged for insertion into a body wound, and a connector removably interconnecting said tubing portions, means forming a part of the evacuator and forming an exhaust opening in communication with said container, and closure means for said exhaust opening, whereby upon compression and release of said container with the tubing end inserted into a body wound, and upon closure of said exhaust opening, body fluids will be extracted from the wound by continuous suction upon expansion of the container and expressed into the container for storage therein.
13. An evacuator as defined in claim 12 wherein said first tubing portion is of larger size, and said second tubing portion is of smaller size, and said connector comprises adaptor means for accommodating and intertting said tubing portions of diiferent size.
14. An evacuator as defined in claim l2 wherein said iirst tubing portion comprises a single reach and said second tubing portion comprises a plurality of reaches in parallel, and said connector comprises adaptor means for accommodating and intertting said single and multiple tubing reaches.
References Cited in the file of this patent UNITED STATES PATENTS 648,858 Dolge May l, 1900 807,905 Blair Dec. 19, 1905 1,736,182 Wilkins NOV. 19, 1929 2,018,322 smily oct. 22, i935 2,122,121 Tillotson iune 28, 1938 2,286,462 Chain lune 16, 1942 2,397,257 Golland et al. Mar. 26, 1946 2,432,288 Danziger Dec. 9, 1947 2,7G4,074 Butler Mar. 15, 1955 2,965,907 Ropelato Dec. 27, 1960 3,632,037 Huber May 1, 1962