US 3351050 A
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1957 F. NAFTOLIN DEVICE FOR COLLECTING URINE FROM FEMALES Filed Nov. 12, 1964 INVENTOR FPEDERNZK NAFTOLJ N ATTOQNEYf:
United States Patent H 3,351,050 DEVICE FOR COLLECTING URINE FROM FEMALES Frederick Naftoiin, 2.746% S. Sepuivecla, Los Angeles, Calif. 90064 Filed Nov. 12, 1964, Ser. No. 410,493 11 Claims. (Cl. 1282) The invention relates generally to a novel means for collection of urine from female human beings and relates more specifically to a device for collection of a clean or uncontaminated urine sample from females.
Normal practice in female urine collection requires that a woman urinate into a container placed in the vicinity of her urethra and vagina. The exact location of the urethra is not too well known by many females and hence, proper location of the container becomes a problem. Aside from the placement problem a container properly placed in the vicinity of the perineal region does not collect a clean or uncontaminated sample of urine because the urine, in passing through the urethral opening, necessarily passes between the labia of the vagina and is contaminated by the secretions, debris and bacteria adhering thereto.
In many cases it is important to have an uncontaminated urine sample, e.g., from pregnant women and from women undergoing postpartum care. In order to prevent perineal contamination of urine samples, female urine specimens are obtained by a clean voided (clean-catch) technique or by catheten'zation. However, both of these techniques have serious disadvantages.
A clean-catch sample of the prior art is obtained by first carefully cleaning the urethral meatus and the vulva and then collecting the urine sample by means of a bottle container placed in the perineal region. The clean-catch method is nevertheless not considered too accurate, and in persons of some obesity, the method is less accurate because the urethral meatus and vulva cannot be cleansed too readily.
Catheterization is an accurate but sometimes painful, time-consuming, and relatively expensive procedure requiring insertion of a tube into the urethral passage. Additionally, this technique is disadvantageous in that it frequently may cause infection and an attendant is necessary.
Bearing in mind the foregoing facts, it is a major object of the present invention to provide a urine collection device for females which is readily positionable by the user without the need for an attendant and which device substantially prevents contamination of the urine sample collected without the need for catheterization.
It is another object of the present invention to provide a urine collection device having means for accurate positioning of the device relative to the urethra and which device substantially prevents contamination of the urine sample collected by isolating the urethra from the areas of contamination, namely the anus, vulva and the vagina.
These and other objects of the invention'will become clearly understood with reference to the following detailed description and to the accompanying drawings, in which:
FIGURE 1 is a perspective view of the presently preferred embodiment of the urine collection device of the invention;
FIGURE 2 is a cross-sectional view along the longitudinal axis of the urine collection device shown in FIG- URE 1, the device being shown properly positioned for collection of a urine sample;
FIGURES 3 and 4 are cross-sectional views along lines 33 and lines 4-4 respectively of the device shown in FIGURE 1; and
FIGURE 5 is a front elevational view of the urine collection device shown in FIGURE 1, positioned for collection of a urine sample.
In general, the urine collection device of my invention is so designed so that not only are the labia held free of the urinary stream but the device positively separates the urethral orifice from the vagina and anus and thereby prevents contamination of the urine sample.
The mine collection device is shown, in perspective, in FIGURE 1, and is designated generally by the numeral 10. The device 10 has three main sections all (preferably) integral with each other, these sections being the normally upper curved end or hooked head section 12, a throat section 14, and a main body section 16. The device 10 and all three sections thereof are preferably molded from any one of a number of plastic resin compositions, which plastic resin compositions, upon curing have some flexibility in the sheetlike thicknesses employed herein (which are of the order of A to A3). Polyethylene resins, polypropylene resins, polymethyl methacrylate and pva compositions are examples of usable plastic resin materials.
The upper end of head 12 of my device 10 forms an approximately angle with the plane of the throat 14 as viewed along the longitudinal axial cross-section thereof (FIG. 2), although an angular relationship of as low as 10 or as great as is also operative. The upper edge 12a of head 12 is smooth and is centrally dimpled or notched at 12b for indexing purposes behind the urethral opening of the user, as will now be described.
The female normally assumes a sitting position preparatory to insertion of the device 10 although she may assume a reclining position as well. The sitting position is illustrated in FIGURE 2, the reclining position in FIG- URE 5.
The labia 31 (mains and minus) of the female user are spread apart and the head 12 of the device, preferably having a leading convex surface 13 and. a trailing concave surface 13a, is gently pushed into a position just behind the urethral opening 34 until the notch 12b lodges behind the urethral meatus surrounding the opening 34. The proper position is rather readily felt by the user because the urethral meatus, surrounding the opening 34 protrodes slightly from the adjacent perineal region.
As the head 12 of my device 10 is indexed in the manner just described, the convexed leading surface 13 of the head impinges onto the anterior vaginal wall 36, and completely blocks off the vaginal opening 38. Vaginal secretions are thereby positively prevented from dropping onto the normally upper surface or collection surface of my device 10.
In order to positively prevent any vaginal secretions from flowing along the backside or underside surface of my device and thereby exiting into a collection bottle 40, a barrier layer of plastic may be placed on the undersurface 20 of my device. This barrier layer may assume any one of a number of shapes but preferably is V-shaped and is integrally molded to the undersurface of my device. The barrier layer is designated by the numeral 42 and has a thickness of the order of to Ma".
The side edges of the head 12 of my device taper slightly inwardly into a slightly elongated throat section 14 (see FIGURES 1, 4 and 5). The taper between head 12 and throat 14 is gradual and smooth. The throat section 14 is narrow relative to the main body 16, and outer edges 14a of the throat fare smoothly in an arc of increasing radius into normally upper edges 14b of body 16. The front and back surfaces 20, 22 of throat 14 are generally parallel to each other and are coplanar with a portion of the front and back surfaces 24, 26 of main body 16 as can be seen especially in the cross-sectional view of my device shown in FIGURE 2; however, the front and back surf-aces 2024 and 22-26 respectively of my device 10 are generally centrally dished or convex to present a central trough or channel through which the urine can flow (see FIGURES 3 and 4 especially).
The narrow throat 14 of the device 10, which may have a width of from /2 to 1 /2, depending upon the user, serves to maintain the spread of the labia 31; the main body side edges 14b are contoured generally in accordance with the curvature of the thighs of the user so that there is a minimum of discomfort when the device is in the functional or operative position shown in FIGURES 2 and 5. Also the device 10 is outwardly flared just below the throat 14 so as to present a broad surface area for impingement of the urine.
The collection surface 24 is widest at the upper edges 14b (of the order of 2 to in width), and tapers inwardly to a width at its lower end 44 preferably approximately equal to the throat width. The lower end width is of course variable within limits dictated by the neck diameter of a desired collection bottle.
In order to prevent loss of urine due to spattering the main body 16 has inwardly turned sides or ears 30 integrally mounted onto the side edges of the main body. The ears 30, in turn, have laterally projecting tabs or handles 32 integrally mounted intermediate the upper and lower ends of the body 16. The tabs 32 are provided so that the user can easily hold the device in position. The cars 34) may be curved (as shown) or relatively planar. As shown, the amount of inward turning of the ears 30 varies from zero (at its upper end) to a maximum (at the 7 tabs 32).
The side elevational view of the ears 30 are best seen in FIGURE 2. It will be noted that the ears 30 have their greatest width nearer the upper ends of the main body 16, and that they taper down to a zero width at or near the lower end 44 of the device 1(lthe greater width being required near the upper end of body 16 since that is where the bulk of the urine sample, to be collected, will impinge on the collection surface 24. The approximate main urine impingment area is designated by the dash-dot rectangular area 50 shown in FIGURE 1.
The lower end 44 of the device 10 has a flat split ring 52 integrally mounted thereon, at an angle of approximately 40 with respect to the collection surface 24 as viewed along the longitudinal axial cross-section. The split ring is designed to be easily forced open to receive the neck of a collection bottle 40, as shown in FIGURE 5 especially. The collection bottle is generally automatically held in a vertical receiving position by means of this arrangement.
The split ring 52 is preferably mounted just below the plane of surface 24, as shown in FIGURE 2, and an undercut portion 54 is provided to receive a slightly enlarged mouth 58 of bottle 40. A lip 60 is thus provided at lower end 44 which overhangs the mouth 58 of the bottle 40 and prevents any leakage of urine therefrom.
Test tapes or papers 62 "may be placed in the bottle 40 to give an immediate indication of various items of interest (e.g., pH, protein, sugar, acetone, etc.).
Attention is drawn to the fact that my urine collection device is very inexpensive to manufacture, and may be considered to be a throwaway item after a single use. This, of course, is a decided advantage in eliminating time-consuming procedures to obtain sterility.
Further-more, my device is much more comfortable to the user than prior art collectors, having a funnel-shaped or completely round mouth or entry for the urine. Such funnel-shaped mouths or entries are not only uncomfortable but do not have positive means for separating the vaginal and anal secretions from the urethral orifice as is the case with my device. The mouths of prior art devices are generally large enough to even cover both the urethral and vaginal opening. The provision of a curved head and an indexing means thereon to locate the head, so that it positively prevents contact of vaginal secretions with the urethral opening and with the urine itself is believed to be a substantial advance in the art of clean-catch urine collection. No attendant is required and the risk of infection is substantially avoided.
Attention is also drawn to the means for preventing loss of urine sample, including the inwardly turned ears 30, the broad surface area for collection, and the snap-on means provided for the collection bottle.
While I have shown a presently preferred embodiment of my device, changes and modifications may be made by those skilled in the art which fall within the scope of my invention. I intend therefore to be bound only by the scope of the claims which follow.
I claim: 1. A urine collection device, which comprises: an intermediate throat member having a normally upper and a normally lower end, and having at said upper end thereof, a hooked member angled upwardly with respect to said throat member, said throat member flaring arcuately and outwardly into a main body member .aflixed at said lower end thereof, the arcuate surfaces thereby formed generally conforming in shape to the thighs of a user of said urine collection device, said body member having a section thereof substantially wider than said throat member and said main body tapering inwardly to a lowermost end;
side members, aflixed to and acutely angled upwardly with respect to said main body member; and
means for receiving a receptacle for urine attached to said lowermost end of said main body.
2. The device of claim 1 wherein said throat member and hooked member is of such width as to enable its ready insertion within the labia of the vulva.
3. The device of claim 2 wherein said throat member and said main body member are slightly dished along their longitudinal axes.
4. The device of claim 1 wherein said throat member, said hooked member, said main body member, said side members, and said means for receiving a receptacle for urine collection are all integral with each other.
5. The device of claim 4 wherein said integral parts are all composed of a flexible plastic.
6. The device of claim 2 wherein said hooked member is a concave-convex member.
7. The device of claim 2 wherein said hooked member has an indexing means formed in its upper edge.
8. The device of claim 2 wherein said side members are angled inwardly towards each other.
9. The device of claim 2 wherein said side members have integrally molded therein at least one tab member.
10. The device of claim 2 wherein said means for receiving a receptacle comprise a flat split flexible ring adapted to snap onto a receptacle.
11. A urine collection device, which comprises:
an intermediate throat member having a normally upper and a normally lower end, and having at said upper end thereof, a hooked member angled upwardly with respect to said throat member, said throat member and said hooked member being of such width as to enable their ready insertion within the labia of the vulva of a user of said device, and having aflixed at said lower end thereof a main body member having a section thereof substantially wider than said throat member, said main body having an undersurface and having an integrally molded barrier layer disposed thereacross and said main body tapering inwardly to a lowermost end;
side members, affixed to and acutely angled upwardly with respect to said main body member; and
means for receiving a receptacle for urine attached to said lowermost end of said main body.
(References on following page) 5 References Cited UNITED STATES PATENTS 4/ 1902 Taylor 4-110 3/1934 Judah 4110 8/1945 Wells 4110 12/1949 Kinyon 41 10 3/1961 Plymale 128-283 1/ 1964 Terrnan 128-295 5/1964 Hill 4--110 6 3,161,891 12/1964 Bauman 4-110 3,240,384 3/1966 Lermer 220-60 FOREIGN PATENTS 5 1,134,812 12/1956 France.
RICHARD A. GAUDET, Primary Examiner. ROBERT E. MORGAN, Examiner. K. L. HOWELL, Assistant Examiner.