US 3421509 A
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Description (OCR text may contain errors)
Jan. 14, 1969 J. M. FIORE URETHRAL CATHETER Sheet 2 ['7 vent-Or Job)? /2 F7'0'r'e Jar/44% Attorne y Filed D80. 17.
United States Patent 3,421,509 URETHRAL CATHETER John M. Fiore, 556 Pinewoods Ave., Troy, N.Y. 12180 Filed Dec. 17, 1965, Ser. No. 514,499 US. Cl. 128349 Int. Cl. A61m 25/00 11 Claims ABSTRACT OF THE DISCLOSURE This invention relates to a urethral catheter and, more particularly, to a urethral catheter of improved insertion characteristics and contamination prevention means.
Urethral catheters are well known medical instruments utilized to remove urine from the bladder, particularly from humans, during the course of or as a result of med ical treatment, diagnosis, and related reasons. As a prerequisite the urethral catheter is a long, thin, flexible and sterile tubulation which is inserted into the urethra to progress past the trigone muscle and into the bladder to withdraw urine therefrom.
Because of the insertion into the bladder, sterility of the instrument is of extreme importance to prevent transmitting of, for example, pathogens and other harmful bacteria from a contaminated instrument to the patient. This contamination may be caused by improper sterility procedures or through inadvertent improper handling of the instrument. More importantly, however, the distal end of the instrument should arrive at the bladder in relatively sterile form, i.e. should not be a carrier of whatever form of contamination may be present at the fossa navicularis of the urethra when passing therethrough.
Accordingly, it is an object of this invention to provide an improved urethral catheter.
Another object of this invention is to provide an improved urethral catheter having contamination preventing means.
An object of this invention is to provide an improved urethral catheter having ancillary means to prevent contamination thereof in the beginning portions of the urethra.
A still further object of this invention is to provide a urethral catheter utilizing its packaging wrapper to facilitate insertion in a sterile manner.
Another object of this invention is to provide an improved single use disposable urethral catheter.
A still further object of this invention is to provide an improved combined single use disposable urethral catheter and packaging or wrapper means for facilitating insertion and use.
Briefly described, this invention in one of its preferred forms includes a short separable protective sleeve-like or liner assembly which is inserted into the outer extremity of the urethra. This sleeve assembly includes internal means in the form of a flexible curtain or cover which is actuated by the action of a tubular catheter passing through the sleeve into the urethra, and peripherally overlies the end of the sleeve. Therefore, the catheter is passed through the first and usually contaminated portion of the urethra without coming in physical or direct contact therewith, and contaminants which may be present in the outer end of the urethra are covered by the sleeve and are not carried by the catheter into the upper reaches of the urethra, bladder, etc.
In a preferred form of this invention the sleeve as well as the catheter is made of a readily and economically disposable material, preferably the non-metals such as certain forms of rubber, plastics, etc. The invention, however, is adaptable for various forms of catheters of the well known kinds including the metallic and ordinarily non-disposable varieties.
These and other aspects of my invention will be better understood when taken in connection with the following description and the drawing in which:
FIG. 1 is a cross-section illustration of a well known urethral catheter;
FIG. 2 is an exemplary illustration of a protective sleeve unit in accordance with this invention;
FIG. 3 is a distal end view of FIG. 2 along the line 33;
FIG. 4 is a schematic illustration of the urethral catheter of FIG. 1 in the sleeve of FIG. 2;
FIG. 5 is a modification of the sleeve unit of FIG. 2; and
FIG. 6 is an illustration of one form of a packaging assembly of this invention.
An exemplary urethral catheter which may be employed in this invention may take the form of the well known self retaining catheter 10 as illustrated in FIG. 1. In FIG. 1 the catheter 10 includes a catheter tubulation 11 preferably of a rubber, plastic, or other single use readily disposable material, The material should have good flexibility characteristicsv with good breakage resistance, be non-toxic to human tissue, etc. Tubulation 11 in cludes an open proximal end 12 and an opposite open distal end 13 interconnected by bore 14. Ordinarily the smooth rounded portion 15 of distal end 13 is inserted into the urethra in sliding contact threwith to pass through the urethra into the bladder. In some self retaining catheters, a thin wall rubber-like distending section 16 is defined by a hollow or cavity 17. Cavity 17 is connected by separate sterile saline admittance passages 18 to a separate end terminal 19. By this means, after insertion of the catheter with the distal end 13 in the bladder,
fluid under pressure in passages 17 causes section 16 to bulge or distend outwardly in the bladder, as illustrated in phantom, and retain the catheter within the bladder for extended use.
The catheter tubulation portion 11 of this invention is of a material which is readily formed in tubular configuration of small internal diameter, easily flexible without breakage and of a structural integrity suflicient to absorb the usual forces necessary to insert the catheter in the urethral passage without dimensional changes. Because of the catheters use in direct contact with human tissue, the catheter material must be non-toxic to human tissue while at the same time not being deleteriously affected by the usual secretions and fluids encountered in the urethra. An important characteristic of the catheter material is that, in addition to the desirable features above mentioned, the material should be of an economical and readily disposable nature. In the preferred form of this invention the catheter is of an economically disposable single use type which is discarded or otherwise rendered unusable for catheterizing purposes after a single use.
This single use feature obviates the present requirement of sterilization of the catheter after each use, and the ever present possibility of transfer of contamination from one person, ie the medical practitioner, assistant, patient, to another patient. The single use concept may be further identified by having the catheter coated with an innocuous substance which will produce a color change when wetted, or by the change of relationship or disarray of parts after use. Exemplary desirable materials meeting the foregoing characteristics are the well known plastics including those known as Nylon, Teflon, etc. One preferred class of plastics materials is linear polyolefin, one of which, linear polyethylene being a specific example, for use in this invention.
The urethra is recognized as an area which is subject to frequent cleansings by passage of urine therethrough. The urinary process aids in preventing contaminants or infectious material from passing upwardly through the urethra into the bladder causing infections of the kind which are then not removed by further passing of urine, or infections which spread beyond the urethra and bladder, to the kidneys, for example. At the same time these infections are most diflicult to treat effectively because of their location and the necessity of continuing the function of the urinary system during treatment. The secretions or contaminants of primary concern are usually found only in the lower or outer extremity, i.e. fossa navicularis, of the urethra. For example, the urethra in the adult male will be maintained in a relatively clean condition from the bladder to a region in the neighborhood of about 1 inch from the meatus. The remaining or end portion, i.e the fossa na-vicularis, is the source of many urinary infections which, for a number of reasons, including catheterization, may be transmitted to other parts of the body.
It is recognized that the mechanism or process of catheterization is a leading cause of urinary infections. For this reason, the practice of catheterization in many instances of diagnosis and treatment is used with hesitancy and caution. Because of this exposure to infection, increased usage and applicability of catheterization for different forms of treatment is limited. In the catheterization process the usual tubular catheter is inserted into the urethra and passed into the bladder. The catheter makes direct sliding contact with the walls of the terminal or end portion of the urethra. In so doing the catheter becomes contaminated and the contaminated catheter, as well as the contaminant material, is carried along or forced into the upper region of the urethra, and in many instances into the bladder itself with consequent more serious infections. The overriding obstacle to increased usage of an invaluable process such as catheterization is, therefore, the infection exposure from its use.
It has been discovered that the use of a sleeve or liner unit device in the catheterization process may materially reduce infections caused from transferring contaminants from one part of the urethra to another, by or from the catheter unit itself. An exemplary sleeve unit is illustrated in FIG. 2. Referring now to FIG. 2, sleeve unit 20 comprises a sleeve, barrel or ferrule portion 21 extending from a radial shoulder or guard 22 which defines open proximal end 23 for bore 24. Barrel portion 21 in one form extends longitudinally about 1 /2 inches from shoulder 22 with a slight external taper surface 25 tapering towards open distal end 26. Distal end 26 includes a well rounded projection 27 commencing at bore 24 and flaring in a curved manner to provide the projection 27.
The external average diameter of the barrel portion 21 may be on the order of about to inch while the bore 24 or inside diameter may be on the order of /8 to inch. Barrel 21 is adapted to be slidingly inserted into the proximal or outer end of the urethra with total insertion into the urethra limited by shoulder 22. The rounded projection 27 with its smoothly curved and flaring surface facilitates insertion into the urethra and at the same time provides a volume or space between the flaring surface and the urethral wall to collect any swept up quantities of contaminant material, so that contaminant material entry through end 26 into bore 24 of barrel 21 is limited. The shape of projection 29' may be of a more pronounced taper to provide a greater volume or collecting space for contaminant material. The outer periphery of barrel 21 may also be provided with smooth linear or curved con'volutions which may be in the form of longitudinally extending corrugations to also facilitate insertion and provide axially extending channel-like recesses for contaminant materials. The material for sleeve unit 20 is preferably the same as described for the single use catheter 10. However, one or the other, or both, may be of the single use type.
While the sleeve unit itself will provide a measure of protection, a major and more significant degree of protection is obtained through the use of an overlie device or flap assembly 28. Overlie device 28 comprises in essence a frame or support member in the form of a ring 29 which resides concentrically within bore 24 of sleeve 20. One method of retaining the frame member 29 within 'bore 24 is by means of groove 30 into which frame ring 29 is resiliently pressed.
Frame ring 29 which is ring shaped suitably supports a number of overlapping wedge-shaped flap segments 31 which effectievly close off the bore 24. Segments 31 overlap each other laterally and also oppositely, i.e. over the center. Segments 31 are of a thin flexible film material such as a plastic, fabric, etc., and are adapted to be axially traversed and radially spread upon entry into bore 24 of catheter 10. Frame ring 29 may be an integral part of the sleeve unit 20 to which a number of segments or flaps 31 are suitably joined. Segments 31 may also comprise a single apertured peripheral film which is folded to provide wedge-like segments, and which in effect may be peripherally unfolded upon insertion of the catheter tubulation 11 of FIG. 1. A spiral curtain arrangement may also be so employed. FIG. 3 represents a distal end view of the sleeve of FIG. 2 illustrating one embodiment of the invention where four wedge-like segments are employed.
FIG. 4 illustrates the operation of overlie device 28 with catheter tubulation 11 inserted therein. As illustrated, the insertion of sleeve 20 into the urethra may gather some secretion or foreign matter about the distal end 26 so that a catheter in passing through open distal end 26 may become contaminated by direct contact with the foreign matter or secretions. Segments 31 are of sufficient length radially and are positioned sufliciently close to end 26 so that they are caused to substantially overlie end 26 not only axially, but also in a continuous peripheral manner as illustrated in FIG. 4. These segments permit the catheter to be inserted past open end 26 without contactingany secretions material gathered near end 26. The overlie device '28 may also be described as a caterpillar arrangement, i.e. a device which lays down its own tread in rolling contact, and which tread is peripherally continuous to provide a wall impervious to transfer of contaminant material therethrough at least during the time catheter insertion takes place. After the catheter 10 is inserted into the bladder the sleeve device 20 may be removed particularly when the catheter may be retained in position for extended periods of time.
As an added precaution, for example, in those instances where risk of infection is to be specifically avoided, additional sleeve units 20 may be employed where the second is inserted through the first to activate the overlie device of the first sleeve and provide a second overlie device of the second sleeve at a deeper point of penetration. Furthermore, where desirable, a number of overlie devices 28, on an extended spiral form, may be employed in axially spaced relationship to each other at end 26. These devices overlie each other axially for added protection, and where individual segments are employed, they are peripherally rotated with respect to each other so that the segments overlie each other as petals, scales, platelets, etc.
One exemplary modification of an overlie device is illustrated in FIG. 5. Referring to FIG. 5 a sleeve unit 32 includes a barrel portion 33 and a guard portion 34 similar to the sleeve 20 of FIG. 2. However, attached to end 35, or as a part of the material of barrel 33 is a tubulation 36. Tubulation 36 is of a thin, flexible material which is impervious to contaminants as described for overlie 28 of FIG. 2. For example, the material for tubulation 36 may be of thin plastic film or suitably impregnated woven or unwoven cloth-like materials. As illustrated in FIG. 5, tubulation 36 extends reentrantly into bore 14 of catheter from the end 35 of barrel 33. As the catheter tube 11 is inserted further through sleeve 32, tubulation 36 is cauesd to unroll upon itself in a toroidal manner to cover any contaminant material about end 36 of sleeve 32. As illustrated in phantom view, continued insertion of catheter 10 unrolls tubulation 36 to its limit and thereafter progresses through tubulation 36 and into the bladder. Tubulation 36 need not provide a path more than that of overlie device 28 of FIG. 2, but may extend to /2 inch :or greater from end 36 depending on choice of film material and mechanical unrolling limitations. It is understood that the sleeve devices, as well as the overlie devices, may be provided with lubricant materials to enhance their overall efiectiveness.
While it is of utmost importance to pass the catheter through the potential danger zone of the urethra, defined by a length extending perhaps an inch or more into the urethra from its external or proximal opening, it is also important that the catheter itself be sterile or free from contaminants. In the first instance, it is preferred that the catheter 10 be of the single use disposable kind so that potential transfer of contaminants from one patient to another be avoided. Secondly, it is important that the catheter not be brought into contact with any other potentially contaminating object, even the person of the medical practitioner. For this reason, medical practitioners use sterile and disposable gloves for the insertion procedure. This procedure, therefore, requires a supply of disposable gloves at the same time and place of the catheterization, as well as being limiting to some degree, of manual freedom.
Therefore, in one form of this invention the single use catheter and a sleeve unit are contained in separate or combined in one sterile wrapper or bag and are therefore ready for immediate use. Furthermore, the bag may be provided with a tear strip or other aperture providing means so that the catheter may be inserted directly from the wrapper into the urethra by manipulating the wrapper. The wrapper itself may also have a portion or area readily punctured by the catheter for insertion into the urethra.
A preferred packaging method suitable for the combined sleeve and catheter is illustrated in FIG. 6. In FIG. 6 the sleeve device, for example, sleeve device 20 and the catheter 10 are included in a first Wrapper or bag 37. The arrangement is such that the sleeve 20 and catheter 10 are arranged in fore and aft relationship in the manner of their expected use. Thus, barrel 21 faces one end of the oblong package, while the catheter is coiled with its inserting end adjacent the guard end of barrel 21. Wrapper 37 is attached or sealed to the periphery of guard 22 or otherwise formed so that the portion covering the barrel 21 may be removed by tearing, tear strip, etc. while the remainder of the wrapper containing the catheter 10 remains intact and in position. Consequently the sleeve device 20 may be inserted into the urethra without contact with any other object. Furthermore, the catheter 10 may then be inserted through sleeve 20 and into the urethra without contact with any external object by manipulating the wrapper. Wrapper 31 may be in fact two separate and opposed wrappers with their opposed open ends sealed to the rim of shoulder or guard 22. Because of the specific mechanical useage of wrapper 37 the material thereof may need further protection. Therefore, a secondary or outer wrapper 38 is provided. It is only necessary that the interior of the inner wrapper be sterile in accordance with this invention. The packaged catheter is also prelubricated for proper use or a section of the wrapper may be employed to contain a suitable lubricant.
While other modifications of this invention and variations of apparatus may be employed within the scope of this invention and have not been described or illustrated, the invention is intended to include all such modi fications as may ordinarily be embraced within the following claims.
What I claim as new and desire to secure by Letters Patent of the United States is:
1. In a urethral catheter combination (a) a short separate sleeve element adapted to be inserted into the outer extremity of a urethra and having an open proximal and distal end for the passage of a catheter therethrough,
(b) overlie means in said sleeve spaced from the said proximal end thereof,
(c) means to actuate said overlie means upon passage of a separate catheter through said sleeve,
((1) said overlie means extending a short distance from and continuously circumferentially overlying the distal end of said sleeve to prevent potential contamination of said catheter by contaminant next adjacent the distal end of said sleeve.
2. The invention as recited in claim 1 wherein said sleeve is a single use disposable plastic material.
3. The invention as recited in claim 1 wherein a plurality of overlie means are employed.
4. The invention as recited in claim 1 wherein a plurality of sleeve elements are utilized one of which is adapted to be inserted through the other to extend therefrom in said urethra.
5. The invention as recited in claim 1 wherein said sleeve is a single use separate disposable item and contained separately in a sanitarwrapper.
6. The invention as recited in claim 1 wherein said sleeve is a single use disposable item of a linear polyolefin material.
7. The invention as claimed in claim 1 wherein said overlie means comprises a plurality of circumferentially adjacent and overlapping film segments which open axially and radially continuously in interleaving relationship and overlie the distal end of said sleeve on passage of said catheter therethrough.
8. The invention as recited in claim 1 wherein said overlie means comprises a transverse wall of contaminant impervious film-like material having means to define an aperture therethrough so that passage of a catheter through said sleeve actuates said wall to provide a peripherally continuous cover overlying the distal end of said sleeve and a portion of the urethra next adjacent thereto.
9. The invention as recited in claim 1 wherein limit means on said sleeve limits the insertion thereof into the urethra to no more than about 1 /2 inches from the outer end thereof.
10. A urethral catheter comprising in combination (a) a long thin flexible tubulation adapted to be inserted into a urethra and into the bladder to conduct fluid therefrom,
(b) short sleeve means separate from said tubulation and adapted for operative association with said tubulation upon insertion of said tubulation therethrough,
(c) said sleeve means .adapted to be inserted into the outer end portion of said urethra to have its remote end portion internally of said urethra in an area next adjacent the meatus thereof,
(d) overlie means in said sleeve adapted to be draped from the said remote end of said sleeve to extend into said urethra for a short distance therein by insertion of said tubulation therethrough,
(e) whereby a length of urethra adjacent said sleeve is effectively bridged peripherally continuously by said draped overlie means to prevent contamination of the passing catheter tubulation through the said length of said urethra internally next adjacent said sleeve,
(f) at least said sleeve means being of a single use disposable material,
7 8 (g) and a sterile wrapper enclosing said sleeve means 3,084,693 4/1963 Cathcart 128-349 and said tubulation, 3,154,080 10/ 1964 Rowan et a1 128-349 (h) said sterile wrapper retaining said overlie means 3,169,529 2/1965 Koenig 128-351 and said tubulation in separated relationship. 3,216,420 11/1965 Smith et a1. 128-283 11. The invention as recited in claim 10 wherein said 5 3,332,424 7/1967 Minteer 128-349 sleeve and said flexible tubulation are retained in predetermined separate portions of said sterile sealed wrapper FOREIGN PATENTS with the said sleeve overlie means and said tubulation 362,799 8/1962 Switzerland. in non-operative relationship.
10 DALTON L. TRULUCK, Primary Examiner. References Cited UNITED STATES PATENTS 1,595,180 8/1926 Fisher 128-240 128-239, 343; 206-632 3,050,066 8/1962 Koehn 128-349