US 3332424 A
Description (OCR text may contain errors)
y 1967 w. B. MINTEER 3,332,424
EXTROVERSIVE CATHETER Filed Feb. 5, 1965 INVENTOR.
WILL/4M 8. MINTEEIQ ATTORNEX United States Patent O 3,332,424 EXTROVERSIVE CATHETER William B. Minteer, Bradenton, Fla., assignor to Discon Corporation, Fort Lauderdale, Fla. Filed Feb. 3, 1965, Ser. No. 430,144 Claims. (Cl. 128-349) This invention relates generally to catheters used for the removal of urine from a patient and more particularly to an improved construction that will maintain the catheters sterility prior to usage as well as prevent the introduction of infectious matterinto the patient.
The present use of a catheter in a hospital is both complex and costly because of the need for sterile conditions. Since the catheter is inserted directly into a body opening it is likely that infection will be introduced if the catheter is not sterile. Therefore a sterile kit is usually ordered from a supply room and rubber gloves, etc. are used during the insertion. In addition, the urinary meatus is cleansed with antiseptic solutions just prior to the insertion of the catheter.
Prior art catheters and their methods of use cause a high incidence of bladder infection. Despite all the sterilization precautions taken prior to insertion, the catheter picks up germs at or just inside the body opening. The germs are then pushed into the bladder by the catheter where they cause infection. As a result of the drawbacks in prior art apparatus and methods, the use of catheters in hospitals in general is limited. Particularly in the examining room, the use of the low cost, disposable cath eter of this invention would enable a urine sample to be extracted free of foreign matter.
In one example of the prior art, a semirigid plastic catheter is encased in a rigid introducer tube which is, in turn, encased in a flexible plastic container. The outer flexible casing is provided with a cover portion that is removable by means of a tear strip or the like. However, once the seal is broken, the once sterile catheter tube is exposed to inadvertent handling and contamination. Unless sterile gloves are used in a sterile atmosphere, the aseptic qualities of the device are lost.
Still another example of prior art catheters comprises a hollow, rigid tube into which a flexible sleeve is folded. A portion of the flexible sleeve having an external ringshaped stop member is also positioned on the outside of the operative end of the catheter. In addition to the excessive assembly cost of this particular example of the prior art, there is an additional, inherent danger of infecting the patient. As may be more clearly seen in that portion of the drawing illustrating the prior art, a short exposed length of the flexible membrane is inserted into the body opening before the internal portion of the membrane unfolds and before the catheter begins its travel into the bladder. The catheter must therefore be sterile, the area surrounding the body opening must be cleaned, and the doctors hands must be kept in sterile gloves. These precautions are all necessary in the initial penetration of the exposed catheter membrane since some germs might easily be forced into the open end of the catheter and subsequently into the bladder as the unfolding process begins.
The present invention provides features and advantages not available in prior art devices. The most obvious is the simplicity of construction and usage as well as the attendant low costs. Further, the outside of the catheter itself need not be maintained in a sterilized condition since it never contacts the patient. Only the inside surface of a thin Walled flexible drain tube, which is sterile, is turned inside out to come in contact with the wall of the urinary canal. The catheter itself is formed by a push tube which surrounds the flexible membrane and which is in turn surrounded by another layer of the flexible membrane. Con- See sequently, the push tube only serves to support the flexible membrane, the inner, sterile surface of which comes into contact with the urinary canal. Effectively then only the inner surface of the flexible membrane serves as communication means between the bladder and the urine collection means.
Accordingly, it is an object of the present invention to provide an improved, low cost catheter.
Another object is to provide a catheter that is relatively simple to use and which does not require sterile surroundings and handling.
An additional object is to provide a catheter which is comprised of an internally sterile, flexible membrane.
A further object is to provide an improved catheter having a flexible membrane that is turned inside out during usage in order to present a sterile surface to the wall of the body cavity.
A still further object is to provide a catheter of the aforementioned type with integral urine collecting means.
Another object is to provide a catheter of the aforementioned type that is sufiiciently inexpensive to be disposable after a single usage.
These and other objects and advantages of the invention will, in part, be pointed out with particularity and Will, in part, become obvious from the following more wetailed description of the invention, taken in conjunction with the accompanying drawing which forms an integral part thereof.
In the various figures of the drawing, like reference characters designate like parts.
In the drawing:
FIG. 1 is a side elevational view in section of an ex-' ample of a prior art device;
FIG. 2 is a pictorial view of the present invention prior to usage;
FIG. 3 is a sectional side elevation view of the present invention at the time of partial insertion into a body cavity;
FIG. 4 is a side elevation view of an alternative embodiment of the present invention; and
FIG. 5 is a side elevation view of still another alternative embodiment of the present invention.
Referring now to FIG. 1 of the drawing, the prior art device is seen to comprise an elongated hollow tube C of rigid or semiflexible material such as rubber or plastic. A very thin, tubular membrane M, formed of latex or plastic such as polyethylene, is secured proximate the op erative end 0 of tube C. The central portion of membrane M is folded into tube C and the end oppposite to secured end is rolled over the outer surface of the operative end of tube C. Annular stop member S is formed on the second end of the membrane M.
The dissimilarity between the present invention and the prior art will be readily apparent by a comparison of FIG. 2 and FIG. 1. The present invention 10 comprises a rigid disc-shaped collar member 12 having a central opening 14. On one surface 16 of the collar, an adhesively backed tear-off strip 18 covers the central opening while on the opposite surface 20 of the collar, the open end 22 of an elongated thin walled drain tube 24 is secured. The drain tube may be silicon rubber, latex rubber, or a plastic such as polyethylene. Hollow push tube 26, which may be fabricated from a semirigid plastic, rubber or metal, open at both ends, and having an outside diameter smaller than the diameter of opening 14, slidably fits over the length of the drain tube.
Only the inside surface 24a of drain tube 24 need be maintained in a sterilized condition. After it is applied to the collar, the sterility of inside surface 24a is maintained by strip 18. Alternatively, the strip 18 may be omitted and the sterilized assembly hermetically sealed in a sterile plastic bag. Just prior to usage, the bag is opened and the catheter inserted into the urinary canal in a manner to be described hereinafter.
It may be noted at this time that if strip 18 is utilized, push tube 26 need not be sterilized at all since it can only come in contact with the outside surface 24b of drain tube 24. In this regard, the push tube cannot be considered to be a catheter since it does not come directly into contact with the body orifice nor does the urine to be withdrawn ever come into contact with the push tube. In effect then, the push tube is an axially slidable support sleeve for the elongated, invertible, flexible drain tube.
The foregoing may be more fully appreciated by reference to FIG. 3. Therein it will be seen that protective strip 18 has been removed from disc 12 and surface 16 has been positioned such that opening 14 abuts the body opening and is in registry with the urinary canal. The push tube 26 is manually moved along the length of the drain tube 24 so that they both are inserted into the urinary canal. The drain tube will then be in communication with the bladder. In so doing, the drain tube is turned inside out and the sterile, inner surface thereof becomes the outer surface. It is obvious then that the push tube need not be sterilized or if it is, it need not be maintained sterile. Only the inside of the drain tube must be maintained sterile. The push tube, having the inverted drain tube disposed thereabout, easily slips through opening 14 in collar 12 so that only at the time it is within the body cavity is the sterile, inside surface exposed.
In the embodiment hereinabove described, the urine is transferred to a suitable container (not shown) by cutting or otherwise opening the rearward end of the drain tube. As an alternative to this method, integrally formed collecting means 30 is provided, as shown in FIG. 4. All other structure is the same as the previous embodiment and therefore need not be described again. It should be noted, however, that since the method of use is the same, the inside of the collector is sterile so that the urine sample will not be contaminated.
FIG. illustrates still another embodiment of the present invention. Collar 40 is provided with a circular, tubular extension 42 on the rearward surface 44 thereof. In use, front surface 46 is placed against the body opening so that opening 48 is in registry with the urinary canal. In the manner described hereinabove, internally sterile drain tube 24 is secured about extension 42 and the push tube 26 is positioned about the drain tube. It should be noted that the push tube plus one thickness of the drain tube will slide easily through opening 48 in collar 40. Because of the tubular extension 42, the drain tube is folded over and through an extra length of the collar before it reaches the critical area. This allows about one inch of the drain tube to purge itself before entering the body. A tear-off seal could also be used across opening 48 as in the previous embodiments or the entire, sterilized assembly could be encased in an hermetically sealed, sterile bag. The opposite end of the drain tube terminates either in a closed end which is cut open after insertion into the urinary canal or in a sealed collector bag.
Preferably the materials selected for the flexible, tubular member and the rigid sleeve should have a low coeflicient of friction with respect to each other. Alternatively, one of the lubricants known in the medical arts may be applied to the confronting surfaces of the tubular member and the sleeve in order that they may slide easily relative to each other.
The various embodiments described hereinabove and illustrated in the drawing have a common denominator of low cost, disposability, and ease of use. All of the embodiments require only that the inside surface of a thin walled drain tube be maintained sterilized. The push tube, collar, collector bag and outside surface of the drain tube need not be maintained in a sterilized condition. Whereas in the prior art the catheter is a rigid or semirigid tube that must be handled with great care in order to prevent infection, the present invention provides a catheter comprising a thin walled, flexible drain tube that is turned inside out during application to present a sterile surface to the urinary canal and the bladder.
There has been disclosed heretofore the best embodiments of the invention presently contemplated and it is to be understood that various changes and modifications may be made by those skilled in the art without departing from the spirit of the invention.
What is claimed is:
1. An improved catheter of a size to fit within the urinary canal and adapted for insertion therein for the removal of fluid thereof, said catheter comprising:
(a) a rigid collar having front and rear surfaces and an aperture extending therebetween, said collar being adapted to seat against the portion of a body surrounding a body orifice;
(b) a thin walled, flexible, tubular member having an open end, said tubular member being secured to said collar whereby the open end of said tubular member is in registry with the aperture in said collar; and
(c) a rigid, hollow sleeve member slidably positioned around said tubular member, said sleeve member being axially displaceable into an orifice of the body, said sleeve member passing through the aperture in said collar inside said tubular member whereby said tubular member slides over the forward end of said sleeve member and said tubular member is turned inside out over said sleeve member thereby covering that portion of said sleeve member within the body.
2. The device in accordance with claim 1 wherein the end of said tubular member opposite said collar is closed, said closed end being frangible whereby body fluids collected by said catheter may be transferred to a collection chamber.
3. The device in accordance with claim 1 wherein said tubular member is provided with an integral fluid collection chamber.
4. The device in accordance with claim 1 wherein said collar includes a tubular extension extending from the rear surface thereof, the inside surface of said extension being contiguous with the aperture in said collar, the open end of said tubular member being secured to the outside surface of said extension.
5. The device in accordance with claim 1 including closure means removably attached to the front surface of said collar, said closure means being positioned over the aperture in said collar to maintain the inner surface of said tubular member in a sterile condition prior to usage.
References Cited UNITED STATES PATENTS 3,084,693 4/1963 C-athcart 128-349 3,154,080 10/1964 Rowan et al. 128349 3,168,092 2/1965 Silverman 128-262 X FOREIGN PATENTS 415,482 11/1925 Germany.
RICHARD A. GAUDET, Primary Examiner.
DALTON L. TRULUCK, Examiner.