US 3908664 A
A drainage tubing for wounds is described. The tubing is retained in the wound site in an improved manner by means of an inflatable balloon positioned in the intact, healthy tissue adjacent the patient's skin. The drainage tubing may also have a second, collapsible bulb portion for aseptic back-flushing of the wound site while the tubing lumen is sealed from the exterior.
Description (OCR text may contain errors)
United States Patent Loseff 1 Sept. 30, 1975  WOUND SUCTION TUBE AND 3.176.691 4/1965 Ericson .1 128/349 B 3.398.743 8/1968 I 128/278 3.742.952 7/1973 128/278 Inventor: Herbert Lose, 308 Woodlcy 3.771.527 11 1973 Ruisi 128/350 Rd. Winnctka. 111. 60093  Filed: Mar. 1. 1974 Primary E\'mnt'ner-Richard A. Gaudet Assistant Evnnziner-Henry S. Layton 1 1 DP 447,316 Attorney. Agent, or FirmNorman Lettvin 52 us. c1. 128/350 R; 128/349 B; 128/278 1571 ABSTRACT [51 Int. (:1. A61M 27/00 A drainage tubing for wounds is described. The tubing  Field of Search 1. 128/349 R. 349 B. 349 BV. is retained in the wound site in an improved manner 128/350 R. 350 V. 240. 241. 230. 231. by means of an inflatable balloon positioned in the inl28/2l4.2,214 F,349,350, tact. healthy tissue adjacent the patient's skin. The 128/276 278 drainage tubing may also have a second. collapsible bulb portion for aseptic back-flushing of the wound  References Cited site while the tubing lumen is sealed from the exterior. UNITED. STATES PATENTS 10 Claims, 4 Drawing Figures 3.115.138 12/1963 McElvcnny et a1 128/278 U.S. Patent Sept. 30,1975 Sheet 1 of2 3,908,664
US. Patent Sept. 30,1975 Sheet 2 of2 3,908,664
WOUND SUCTION TUBE AND RETROGRADE I FLUSHING When a patient has a serious, deep wound, or a large abscess, osteomyelitis, or other collections of bodyfluids suchas serumfblood, or pus in the body, drainage method of use.
catheter tubing (commonly called wound tubing) is commonly used to alleviate the situation. Commonly, the wound tubing is made of flexible plastic such as polyethylene, or inert elastomers such as silicone rubber or the like. Typically, the wound tubing is fabricated to have sufficient stiffness so that fluids can be in U.S. Pat. No. 3,115,138.
The wound tubing typically is manufactured with a large number oflateral perforations for communication between the lumen or bore of the tubing and the exterior, the perforations being located in a central portion I the awl, are removed by severing the tubing, and the wound site is sutured.
Various significant problems exist in the prior art wound tubing. First, the restless patient can accidentally, or otherwise, pull on the wound tubing and cause it to withdraw outwardly along its path through the healthy tissue. This can happen when the patient is asleep, or irrational patients and children may intentionally try to withdraw the wound tubing.
Once the wound tubing has been partially or completely withdrawn, those portions of the tubing which have been exposed to the exterior will become contaminated with bacteria, and thus should not be simply reinserted into the patient again, even if this were possible. Accordingly, a wound tubing may have to be reinserted by connecting fresh sterile wound tubing to an awl, and once again punching it through the healthy tissue into the wound site. Also, the stitches holding the wound closed may well have to be re-opened in order to withdraw the awl and to re-position the wound tubing.
Furthermore, at the skin exit hole or holes of the wound tubing, there is a pronounced tendency for blood, lymph or irrigation solution to leak outwardly, which is clearly undesirable. Also, there is the still more undesirable possibility of the migration of bacterial contamination inwardly toward the wound site along the wound tubing, and the consequent danger of infection.
Also, the perforations and the bore or lumen of the wound tubing at thewound site frequently become plugged with debris. To avoid changing of the wound tubing, there is frequently attempted a back flushing procedure, in which sterile flushing solution, such as normal saline, is passed through the wound tubing to flush the solution into the woundsite. This disperses and breaks up the debris which blocks flow in the wound tubing. This technique has its consequent dan- BACKGROUND OF THE INVENTION In accordance with this invention, a drainage device for wounds is provided which comprises a tubular drainage member having a central lumen or bore, and a plurality of drainage ports defined along a first portion of the tubular member and laterally through it for communication between the lumen and the exterior of the tubular member. An elastomeric retention balloon is carried by a second portion of the tubular member 'at one side of the first portion, which defines the drainage ports. The balloon is positioned to be inflatable under the skin of a patient While the drainage ports lie in the wound site. Preferably, the first portion of the tubular member described above is spaced from the ends 10f the tubular member by a convenient length of portfree tubing to permit connection of the tubular member 'with an awl, for installation of the tubular device in a manner described below, as well as to provide other flexibility of use of the wound tubing of this invention.
It is also a preferred feature of this invention to provide an enlarged lumen portion on the tubular drainage member for use as a collapsible squeeze bulb and storage portion, for retention of flushing solution in the tubular member outside of the body, when the drainage device is positioned in a patient with the drainage ports located in the wound site. With this arrangement, the lumen or bore of the tubular member can be sealed from the exterior by appropriate clamp means after filling with flushing solution, and the enlarged lumen portion of the tubular member can be squeezed and manipulated for aseptic back flushing of the drainage device, while the tubular member is sealed against possible bacterial contamination from the outside. Accordingly, the wound site can be bathed or back-flushed with any desired solution in a manner which reduces the risk of contaminating the wound site.
Another preferred feature of this invention is that the drainage ports are of smaller aperture size than the diameter of the central lumen of the tubular drainage member. As a result of this, the drainage ports serve to screen out tissue particles, small blood clots, and the .like, preventing them from entering the central lumen and causing obstruction within the tubular drainage member.
It is generally desirable for the tubular drainage member and balloon member of the device of this in vention to be made of silicone rubber, since such material is highly non-adherent to clots and debris, and is .thus easily flushed. Also, very little tissue reaction occurs in tissue which is in prolonged contact with silicone rubber. Accordingly, the patient may experience considerably increased comfort when a silicone rubber drainage device is used in accordance with this invention.
If desired, organic plastic or rubber drainage devices made in accordance with this invention can be fabri- -.cated with a coating of room temperature vulcanizing silicone rubber or the like for essentially equivalent effect.
Other hydrophobic, flexible thermoplastic materials, such as polyethylene, can also be used with advantage to fabricate the devices of this invention. Other corresponding medical grade materials such as latex rubber and polyvinylchloride plastisol can also be used.
The drainage device of this invention is used to provide the drainage to a wound site or the like in a patient by inserting the tubular drainage member into the wound site in such a position that the lateral drainage ports are in flow communication with the wound site. Also, the tubular member is passed through healthy, intact tissue adjacent the wound site so that one end of the tubular member isexposed to and communicates with the exterior of the patient, and in such manner that the balloon retention member is positioned within the healthy, intact tissue adjacent the skin. Generally, either of the above steps may be performed first with equivalent effect.
After the tubular drainage member has been properly emplaced, the balloon member is inflated, to firmly retain the drainage member in the wound site, so that it is less likely to be accidentally or otherwise removed from proper emplacement by pulling on an exposed portion of the tubular member. Likewise, the pressurized balloon member provides an improved seal at and just below the skin level, which greatly reduces or eliminates bleeding and fluid leakage from the skin hole through which the tubular member passes. The balloon inflation also reduces the possibility that bacterial contamination can enter the skin hole to cause infection.
Other advantages of this invention will be readily apparent from the specific embodiment of this invention described below.
In the drawings:
FIG. 1 is a plan view of the drainage device or wound tubing of this invention, with some portions broken away for showing interior details;
FIG. 2 shows the wound tubing of this invention in an intermediate stage of placement into a large wound in a patient;
FIG. 3 shows the emplaced wound tubing of FIG. 2 after complete emplacement and suturing of the wound, said wound tubing being shown in the process of a back flushing operation to clear the lateral drainage ports within the wound site;
FIG. 4 is a plan view of a second preferred embodiment of the wound tubing of this invention.
Referring to the drawings, FIG. 1 shows a drainage member or wound tubing which comprises a tubular member 11 of flexible, plastic tubing such as silicone rubber, polyethylene, or medical grade polyvinyl chloride plastisol, which is typically about two or three feet in length. The tubing has a lumen or bore 12 which may be about 4? inch in diameter or other diameters as required, and is open at one end 18.
A first, intermediate portion 16 of tubing 11 defines a plurality of lateral 'drainage ports in the wall of tubing 11 for fluid communication between lumen 12 and the exterior of tubular member 11. The portion 16 of the tube is preferably spaced from the ends 18, 20 thereof, by a convenient length of say at least 3 inches, and preferably about 6 to 8 inches of port-free tubing for purposes which will become apparent below.
A retention balloon 22 is positioned at one side of the drainage ports defined in first portion 16 of tubular member 11. Balloon 22 is generally positioned so that it can be inflatable under the skin of a patient when the 27 of tubing 1 1, and enters at one end into communica-- tion with the interior of balloon 22. Inflation tube 26 is preferably separate from tubing 11 at its distal end 28 and carries a clamp 30, or sealing entrance stopper, as well known in the art, for sealing the inflation tube in order to retain the balloon in inflated condition for as long as desired. Balloon 22 is preferably made of an elastomer such as silicone rubber, or, alternatively, natural latex.
The distal portion 27 of tubing 11 also forms an enlarged lumen portion 32, whichmay be used as a collapsible squeeze bulb, as well as a storage portion for retention of flushing solution (such as physiological saline, containing an antibiotic) in a position outside of the body when the wound tubing is positioned in a patient. The distal portion 20 of tubing 11 may be sealed in a conventional screw clamp 34 or the like, so that the entire lumen 12 of the wound tubing may be filled with flushing solution, including enlarged lumen portion 32, and then the clamp 34 may be closed to seal the lumen from communication with the exterior.
FIG. 2 shows a desired technique for emplacement of the wound tubing of this invention in a wound. It should be noted that, for purposes of this invention, the term wound is also intended to include other areas of use of the device of this invention as mentioned above, such as abscesses and other accumulations of body fluid.
As shown in FIG. 2, a conventional awl 36 having a threaded connector member 38, of appropriate size, is threaded into end 18 of the Wound tubing. The wound tubing can then be emplaced in an open wound 40 on the body 42 of a patient. The surgeon penetrates the skin at a point 44 spaced from wound 40, to pass the awl through intact, healty tissue, manipulating the awl so that it enters the wound site at a point 46. Tubing 1 1 can then be drawn through the punctured path 48 through the intact, healty tissue until the portion 16 of the tubing defining the drainage ports 17 lies in the wound site and balloon member 22 has entered skin opening 44. Some surgeons may prefer to allow a portion of balloon member 22 to remain outside of skin opening 44. Also, for best sealing, it is generally preferable for balloon member 22 to reside in essential contact with skin opening 44 and not to be significantly spaced therefrom.
Following this, section 16 of the tubing is positioned as desired by the surgeon in the wound 40, and tubing 11 is severed at a location indicated generally at 49, in accordance with the discretion of the surgeon, so that the awl 36 and usually most of the port-free end portion 18 of the tubing can be removed, as illustrated in FIG. 3. Accordingly, first tubing portion 16 is positioned, without the need to handle or touch it; since manipulations of the tubing for mounting and using the awl 36 can be confined to imperforate end 18 of the tubing. Accordingly, section 16 of tubing 11 can more likely remain in aseptic condition.
As further illustrated in FIG. 3, the wound 40 isthen sutured,'with drainage port-defining portion 16 of tubing 11 remaining positioned within the wound site.
At the discretionof the surgeon', when he believes the wound'tubing to be satisfactorily 'positioned,.balloon 22 FIG. 3 also shows how enlarged lumen portion 32 can be collapsed, generally .by. hand, to force flushing solution through drainage ports 17, as well as the severed end of tubing 11 within wound site 40,,toflush the wound tubing in a n--'aseptic mannenas desired the physician. 1 r I i If the wound site 7 surgeon must,use theawl to define another exit path through intact tissuein order to positio nfthe wound tubing properly. In this event, both ends of thewound tubing protrude from the patient, and can be used for drainage and 'flushing, but the retention and sealing of one end is still provided balloon 22:. For such special use, a secondballoon could be provided for sealing and retaining the second end of the wound tubing Optionally, clamp 34 can be opened to replace'the flushing solution, or to subject the wound site with an alternating suction-irrigation treatment with antibiotics and other medicinals, for bathing the'wound continuously with therapeutic agents. H
FIG. 4 shows anfalternat'iv'e embodiment of the wound tubing of this invention, which comprises a'simi-' lar tubular drainage 'membe r l 1a which defines a plurality of drainage ports 17a defined througha first portion 16a of the tubular member which is spaced from the ends thereof in a manner similar to the embodiment of FIG. 1. A similar balloon sleeve 22a is also provided, and an inflation lumen 26a as well as a clamp 30a for use in similar manner.
It will be noted that, in this embodiment, a tubular portion 50, which is separate from tubing 11a is provided. Tubular portion 50 has an enlarged collapsible lumen portion 52, and a connector means 54 for connection in aseptic, leak-proof manner .with an end of tubing 11a when desired. Connector 54 may be a hollow tubular member with threads on the outside, proportioned to screw into the lumen of tube 11a for connection therewith. Connector 54 may also be a simple nipple or luer to fit into the lumen or bore of tubing 110.
An advantage of the embodiment of FIG. 4 is that it may be either emplaced in a wound 40 in the manner described in FIGS. 2 and 3, or may be emplaced in the wound in reverse manner. An awl may be emplaced in the bore of the opposite end 56 of tube 11a, when compared with the emplacement of the awl as shown in FIG. 3, so that the awl may enter the intact, healty tissue at point 46 and pass through the tissue until it exits at point 44, should the surgeon find it desirable to do so. Of course, clamp 30a must be temporarily removed for this operation, and the free portion of inflation port 26a should be secured completely to tube 11a and optionally tied flat for passage through the intact tissue. Tubing 11a can then be positioned in a manner comparable to that shown in FIGS. 2 and 3, and the awl may be removed. Then, tubular portion 50 may, if desired, be aseptically connected to opposite end 56, and the wound tubing arrangement used in the manner previously described.
is not opento the exterior, then the If desired, tubing :11; or- 1,141 .ma-y beconnected at its respective end 20, 56,to apare'nteral solution container which is hung above thetarrangementflo provide a supply of pressurized flushing'solution as desired. Clamp 34, 34a can be used tocontrol the access of such solution to the tubing 11, llaw When it is determinednthat the wound tubing should be removed; clamp 30, 30a can be released, causing balloon 22,22a to deflate. Tubingll, 11a can then simply be withdrawn through skin hole 44 without opening of the stitches-of wound 40.
While in the preferred use of the invention, the balloon- 22 is positioned to be inflatable in the patients flesh under'the skin, if the doctor feels that it is desirable or advisable,the balloon may also be'located anywhere along the length of the puncture path 48 made by'th'e awl, or even within the wound itself; and be inflated therein. i
It is contemplated' that two (or more) of the drainage devices of this invention maybe simultaneously emplaced in a wound site. Accordingly, one-of the drain age devices may be used as a flushing fluid inlet, while the other drainage device serves" as an outlet for'the fluid and other drainage. 5 The above disclosure has been provided That which is claimed is: 1 In adrainag'e device for wounds and the like, said fluid communication between said lumen and the exterior of said tubular member, the improvement comprising, in combination, an elastomeric retention balloon carried by a second portion of said tubular member located on one side of one end of the first portion, and adapted to be inflatable under the skin of a patient when said first portion is properly positioned in a wound, said tubular member also carrying means for inflating and deflating said retention balloon, a length of severable, imperforate tubing extending from the end of said first portion and having a terminus adapted for screw connection to an awl, said imperforate length of tubing permitting selective connection to an awl without contamination of the drainage ports in said first portion, an enlarged-lumen portion in communication through the central lumen with the drainage ports and for use as a combination squeeze pump and storage portion for retention of a flushing solution therein, and means for selectively sealing said enlarged-lumen portion so that squeezing said squeeze pump operates to back flush solution through the drainage ports.
2. The drainage device of claim 1 in which said drainage ports are smaller in aperture size than the diameter of said central lumen of the tubular drainage member.
3. The drainage device of claim 2 in which said tubular drainage member and balloon member are made of silicone rubber.
4. In a drainage device for wounds and the like, said device comprising a tubular drainage member having a central lumen, and a plurality of drainage ports defined along a first portion of said tubular member and through said tubular member for fluid communication between said lumen and the exterior of said drainage member, the improvement comprising, in combination,
for illustra-d tive purposes only, and is not to be viewed as limiting the invention, which is described inthe claims below. I
an elastomeric, retention balloon member carried by a second portion of said tubular'mernber, and'positioned to be inflatable under the skin of a patient when said drainage ports lie in a wound, saidtubular member also carrying means for inflating and deflating said retention balloon, said retention balloon being located at one side of said first portion, said tubular member also defining, at a location along said tubular member on said one side of the first portion and spaced farther from said first portion than said retention balloon, an enlarged-lumen portion for use as a collapsible squeeze bulb and storage portion'for retention of flushing solution exterior of the body when said drainage device is positioned in a patient, and means for selectively sealing said enlarged-lumen portion from communication with the exterior, whereby said enlarged-lumen portion can be manipulated for aseptic back-flushing of the drainage device.
5. The drainage device of claim 4 in which said drainage ports are smaller in aperture size than the diameter of said central lumen of the tubular drainage member.
6. The drainage device of claim 5 in which said first portion of the tubular member is spaced from the ends of the tubular member by at least about six inches of port-free tubing.
7. The drainage device of claim 6 in which said tubular drainage member and balloon member are made of silicone rubber.
8. The drainage device of claim 6 in which clamping means are provided for sealing the lumen of said tubular drainage member from communication with the ex- 1 terior.
9. The method of providing drainage from a wound site or the like in a patient which comprises:
' inserting a tubular drainage member, having a plurality of lateral drainage ports defined along a first portion of said tubular drainage member, into the wound site in a position such that said drainage ports are in flow communication with said wound site, while also passing a second portion of said tubular member through intact, healthy tissue so that one end of said tubular member communicates with'the exterior,
positioning a balloon retention member carried by said second portion of the tubular member within the intact, healthy tissue adjacent the patients skin at the same time that the tubular drainage member is being positioned in the wound site; and
, inflating the balloon member, to firmly retain the tubular member in the wound site, and to seal the area between said tubular member and said intact, healthy tissue.
, I O The method of claim 9 in which, after positioning of the tubular member and inflation of the balloon member,.the lumen of said tubular member is filled with a physiological flushing solution and sealed from communication with the exterior, and thereafter a flexible, enlarged lumen portion of said tubular member, defined on a portion of the tubular member exterior of said patient, is manipulated to back-force flushing solution out of the tubular member through said drainage ports, to clear the drainage ports and to flush the wound site.