July 3, 1962 M. E. JASCALEVICH DEVICE FOR DRAINING WOUNDS Filed March 9, 1960 PUMP PIE. 1
H mm En W Y In W m R J 6mm E @M m v a R A M f B 3,042,041 DEVICE FOR DRAEYING WOUNDS Mario E. Jascalevich, Weehawken, NJ. (435 60th St., West New York, NJ.) Filed Mar. 9, 1960, Ser. No. 13,898 6 Claims. ((11. 128-276) The invention relates to improvements in means for draining wounds or fistulas.
Following an ileostomy, or other operation involving fistulas accompanied by a substantial discharge for a prolonged period of time,-it is desired to minimize or eliminate contact between the draining fluid and the skin around the stoma; the draining fluid causes severe irritation, masceration, or erosion of the skin. A patient who has undergone an ileostomy, or other operation resulting in a high intestinal or urinary fistula, is not in condition to well endure post-operative damage to and severe irritation of the skin as caused by fluid draining from the fistula.
Various devices have been proposed for withdrawing or draining the skin-corrosive discharge from fistulas. These devices have required the use of straps or adhesive tape to maintain them in position upon the patient. The means used to hold the prior art devices in suitable position with relation to the fistula covers a substantial area of the body. Also, some prior art devices have necessitated the use of dressings, which absorb the draining fluid and cause some measure of irritation because of the contact of the dressing with the skin, thereby further requiring the use of shielding ointments. Following an operation of the type under consideration, the patient wants to be left alone; frequent replacement of the drainage device, the removal and replacement of holding straps and adhesive tape, and the removal and replacement of dressings add to the patients discomfort. Besides, with the prior art devices a substantial measure of nursing care is required.
The primary object of the invention is to provide a device for draining fluid discharged from a wound or fistula in a manner which affords the following combination of advantages: (1) contact of the draining fluid with the surrounding skin is completely prevented; (2) the device is maintained in self-supporting position, exclusive of straps or adhesive tape to assist in holding the device about the fistula; (3) the device is compact and utilizes a minimum area of coverage, thereby fully exposing adjacent areas of the body which may require attention; (4) the device may be used for an extended period of time without removal and replacement, thereby minimizing the nursing problem; and (5) the device may be simply adjusted to the comfort of the patient by the patient himself to his individual needs.
These, and other objects and advantages of the invention will be apparent from the following description, taken in conjunction with the accompanying drawing illustrating a preferred embodiment of the invention, in which:
FIG. 1 is a side elevational view of the drainage device of the invention with relation to suction means for drawing oif the fluid discharged from a wound, and suction means for maintaining the device in position about the wound;
FIG. 2 is a vertical cross-sectional view of the device in operating position upon a portion of the body; and
FIG. 3 is an enlarged view looking in the direction of line 3-3 of FIG. 2.
Referring to the drawing, a device for draining wounds made in accordance with the invention comprises a cuplike member provided at the open end thereof with a continuous edge orrim 12. While the cup-like member may be of any suitable contour, it is preferred that it be conically or funnel-shaped, as shown. Themember 10 ice may be in the form of a short, hollow cylinder closed at one end thereof. The continuous edge orrim 12 may be made as an integral part of the member, or a separate piece of rubber tubing may be split to receive the cup wall and the two parts secured together to provide the continuous, resilient edge. The cup-shaped member and its rim portion are both made of air-impermeable material, whether the parts are integrally formed or separately made and connected. Although the cup-like member may be made of metal, it is preferred that it be made of a suitable plastic material which is also transparent, the transparency permitting viewing of the fistula or stoma F while the device is in operative position upon the skin S and in surrounding relationship to the fistula, as shown in FIG. 2.
A tube, generally designed 14, extends through the wall of themember 10, with the external surface of the tube sealed in air-tight relation with respect to the area or opening 16 where the tube extends through the members wall. The portion of the tube which extends inside of the member is of a length so that the lower end or tip thereof 18 may be positioned in the fistula. The portion of the tube exterior of themember 10 is connected to a suction pump P. Preferably, this suction pump is of the intermittent type, and suitable tubing orlines 17 and 19, with an intermediate collection bottle B, are provided in communication with thedrainage tube 14. The end of the drainage tube which is positioned within the fistula may be provided with a series of spacedopenings 20.
The wall of the air-impermeable member 10 is provided with a second passage or opening 22 for communication, as by atube 24, with a second source of suction, the pump P. This suction pump preferably is of the continuous type.
The wall of thecup 10 is provided with another or third opening ororifice 26 to allow the limited entry of ambient air into the confines of the cup when the cup is in operating position as shown in FIG. 2. The orifice may be a pin-point opening of fixed size, or several pin-point openings extending through the wall of the cup. The purpose of the orifice ororifices 26 will be presently de scribed; also, as will be presently described, it is preferred that the size of the orifice be made adjustable in order that the amount of ambient air permitted entry into the cup may be regulated. In any event, the total diameter of the air passage between the ambient air and the interior of the cup is related to the size of the passage 22 and the degree of vacuum applied by the pump P so that the pressure differential caused by the pump is greater than the loss of pressure due to the ingress of the ambient air into the cup through the orifice.
The operation of the device will be apparent from the showing of FIG. 2. Theend 18 of thedrainage tube 14 is placed in the fistula F with therim 12 of thecup 10 in contact with the skin S and surrounding the fistula in outwardly spaced relation. The suction pump P is started, whereupon the air in the cup is evacuated, causing therim 12 to engage the skin with an air-tight seal. It will be observed that the cups rim is preferably outwardly flared with respect to the body portion of the cup, thereby adding to the comfort of the patient and the effectiveness of the seal. The suction pump P is started, whereupon fluid discharged by the fistula enters thedrainage tube 14 through theopenings 18 and is drawn 011? into the collection bottle B. The contents of the fluid in the bottle is an indication of the entire amount of fluid discharged, for with the device of the invention, none of the fluid seeps over onto the adjoining skin tissue or is absorbed by an unnecessary dressing.
Following an ileostomy, or an abdominal operation involving an intestinal fistula, drainage takes place for a prolonged period of time, generally several days. In
order to ventilate the wound and the area surrounding the wound, thereby permitting the described device to be maintained in position for a prolonged period of time without necessitating its removal and replacement, the ambient air is drawn into the cup, which is vacuum sealed against the skin of the patient, through theorifice 26. Thus, fresh air is circulated in the cup around the wound and passes out through the passage 22 under suction. While a small pin-point opening or openings in the cups wall are suificient to allow the ambient air to enter the cup and ventilate the wound without unduly interfering with the suction effect provided at the passage 22, it is preferred to make theorifice 26 adjustable in size by means, shown for example in FIGS. 2 and 3. By adjusting the size of the orifice, not only may the desired ventilation of the wound be obtained consonant with the maintenance of the seal between thecups rim 12 and the skin of the patient, but in addition, adjustment of the size of the orifice regulates the degree of pressure engagement of the cup with the skin, thereby providing the degree of pressure most comfortable to the individual patient. Furthermore, suction pumps made by the same manufacturer and initially having the same rating, change in their output characteristics wtih use and the passage of time. Hence, it is desirable to make the size of the orifice in communication with the ambient air adjustable for the desired pressure relationship with respect to the vacuum applied at the passage 22.
As shown in FIG. 2, the means for adjusting the ingress for the ambient air into the interior of the cup may take the form illustrated, wherein the wall of the cup, particularly where made of plastic material, is provided with an upstanding, short, cylindrical and integrally formed boss-like portion 28 having theorifice 26 extending through theupper wall 29 thereof. As shown in FIG. 3, theorifice 26 may be provided by anarcuate slot 30 formed in the bossupper wall 29, such slot cooperating with acoincident slot 32 formed in the upper wall of a closely fittedcap 34. The cap is frictionally fitted onto the boss so that the rotation thereof will adjust the effective size of theorifice 26. The patient himself may make the adjustment in size of the orifice to suit his individual comfort or degree of pressure engagement of the cup sealed to his skin.
Also in further detail, thedrainage tube 14 preferably is made as illustrated to comprise a piece ofrigid tubing 36, such as stainless steel, which may be sealed to thecup 19 by asuitable clamp 38. If desired, the adjacent surfaces of the cup wall and the outer surface of the rigid tube may have cement applied thereto so that the seal will surely be air tight. With the rigid tubing sealed to and extending through the wall of the cup, the lower end 40 of the tube permits the connection thereto of any desired length offlexible tubing 42, the lower end of which is to be positioned in the fistula. In this way, a piece ofdrainage tubing 42 may be cut to desired length, suitable to the individual needs of the particular size or depth of the fistula without in any way disturbing the air-tight seal between the tubing and cup wall. The opposite end of the rigid,short length tubing 36 is connected by theflexible tubing 17 to the collection bottle B.
While the described combination of rigid and flexible tubing is preferred, it will be understood that flexible tubing may be used throughout. The described arrangement is preferred because of the advantages aiforded from the standpoint of airtight sealing, and ready adaptability to individual cases.
Regarding passage 22, such passage is most conveniently provided by molding anipple 44 integrally with the wall of thecup 10, when the cup is made of plastic material as previously described.
It is believed that the advantages of the invention will be apparent from the foregoing described and illustrated embodiment of the invention. The drainage cup is maintained in self-sustaining position without the necessity of auxiliary straps or adhesive tape, which cause added discomfort to the patient. The fluid discharged from the fistula is entirely drained off, leaving the skin adjoining the incision in a healthy condition and free of the irritating effects of the corrosive discharges. Although the drainage device of the invention is maintained in position by suction, and therefore in pressure engagement with the skin, the degree of pressure may be readily adjusted to the comfort of the patient without breaking the seal. Of even more importance, the device permits air to be circulated around the wound so that the device may be maintained in desired position over a prolonged period of time, without bothering the patient and with little need of attention.
It will be understood that various changes and modifications may be made without departing from the spirit and scope of the invention as sought to be defined in the following claims.
I claim:
1. A device for draining wounds comprising a cuplike member of air-impermeable material, said member having an edge at the open end thereof adapted to engage the skin in spaced relation to a wound, a wound drainage tube extending through the wall of said member and in sealed relationship therewith for connection to suction means, said wound drainage tube being of a length to permit the tip thereof to be inserted in the wound, a passage extending through the wall of said member adapted for connection to a second suction means and evacuation of the air in said member to thereby maintain the member in self-sustaining pressure engagement with the skin, and an orifice in the wall of said member to allow the limited entry of ambient air into the member.
2. A device as set forth in claim 1, wherein the wound drainage tube comprises a section of rigid tubing, the outer surface of which is permanently sealed to the adjacent portion of the members Wall, and the end of the rigid tubing section inside the cup-like member being in communication with a section of flexible tubing for insertion into the wound, the outside end being adapted for connection to said suction means.
3. A device for draining wounds comprising a cuplike member of air-impermeable material, said member having an edge at the open end thereof adapted to engage the skin in spaced relation to a wound, a wound drainage tube extending through the wall of said member and in sealed relationship therewith for connection to suction means, said Wound drainage tube being of a length to permit the tip thereof to be inserted in the wound, a passage extending through the wall of said member adapted for connection to a second suction means and evacuation of the air in said member to maintain the member in self-sustaining pressure engagement with the skin, an orifice in the wall of said member to allow the limited entry of ambient air into the member, and means for adjusting the size of the orifice.
4. A device as set forth in claim 3, wherein the wound drainage tube comprises a section of rigid tubing, the outer surface of which is permanently sealed to the adjacent portion of the members wall, and the end of the rigid tubing section inside the cup-like member being in communication with a section of flexible tubing for insertion into the Wound, the outside end being adapted for connection to said suction means.
5. A device for draining wounds comprising a cuplike member of transparent plastic material, said member having an edge at the open end thereof adapted to engage the skin in spaced relation to a wound, a wound drainage tube extending through the wall of said member and in sealed relationship therewith for connection to suction means, said wound drainage tube being of a length to permit the tip thereof to be inserted in the wound, a nipple formed integrally with the wall of said member adapted for connection to a second suction means and evacuation of the air in said member to thereby maintain the member in self-sustaining pressure engagement with the skin, a boss formed integrally with the wall of said member, said boss having an orifice eX- tending therethrough, and a closely fitting cap mounted on the boss, said cap having an opening therein for positional adjustment with respect to said orifice to allow the regulation of ambient air into the member, whereby the area within the member may be ventilated and the pressure of the member with the skin may be adjusted.
6. A device as set forth in claim 5, wherein the Wound drainage tube comprises a section of rigid tubing, the
outer surface of which is permanently sealed to the ad- 10 jacent portion of the members wall, and the end of the rigid tubing section inside the cup-like member being in communication with a section of flexible tubing for insertion into the wound, the outside end being adapted for connection to said suction means.
References itetl in the file of this patent UNITED STATES PATENTS 1,995,051 Benson Mar. 19, 1935 2,122,121 Tillotson June 28, 1938 2,524,750 Bellinger Oct. 10, 1950 2,944,551 Breer July 12, 1960 FOREIGN PATENTS 1,047,107 France Dec. 11, 1953 114,754 Great Britain Apr. 18, 1918 641,061 Great Britain Aug. 2, 1950