WO1985004108A1

WO1985004108A1 - Prophylactic rectal douching device

Info

Publication number: WO1985004108A1
Application number: PCT/US1985/000434
Authority: WO
Inventors: Erick-Pierre Fournier
Original assignee: Fournier E P
Priority date: 1984-03-19
Filing date: 1985-03-18
Publication date: 1985-09-26
Also published as: AU4151285A; EP0175760A1

Abstract

A prophylactic rectal douching device (10) includes a plastic squeeze bottle (12) having a cap (16) with an elongated nozzle (14) mounted thereon and extending upwardly therefrom. The cap (12) is divided into an upper portion (16a) and a lower portion (16b) and includes a living hinge (18) between the two which allows the upper cap portion and nozzle to pivot out of the way to expose the open top of the bottle for refilling the same with tap water. This is done without having to remove the entire cap and nozzle from the bottle. A locking mechanism (20, 22) maintains the upper cap portion (16a) and nozzle (14) in their upright operable position during use. The nozzle (14) includes a plurality of spaced apertures (30, 34) which are designed to dispense liquid from the bottle (12) at optimal angles. Flow splitters (50, 52) within the nozzle equalize the flow rate and pressure among the various apertures. The nozzle is also adapted to carry a supply of medication (58) which is intended to be added to the douching fluid.

Description

PROPHYLACTIC RECTAL DOUCHING DEVICE

Technical Field

This invention relates to douching devices and more particularly to convenient, safe and inexpensive means of rinsing out the rectal cavity known as the ampulla. While the present inventive products address themselves in general to patient's suffering from vari¬ ous enteric parasitic infections, they are primarily directed to people involved in anal sexual relations for routine, preventive hygiene and/or therapeutic treatment.

Background Art

Oral-genital-anal sexual relations performed with- out regards to intimate cleanliness can lead any active partner to a variety of serious and debilitating dis¬ eases such as Amebiasis, Hepatitis A or Salmonella. An infected active partner can transmit to any passive party some equally serious disorder such as Proctitis, Herpes, Hepatitis B or Gonorrhea. Furthermore, frequent and/or careless anal intercourse can easily cause inter¬ nal damage to the fragile lining of the rectal cavity and sphincter muscles in the form of anal fissures, tears or bleeding hemorrhoids. Through these breaks in the lining, microscopic as they may be, infective agents carried along by the semen can enter into the bloodstream and create severe systemic conditions. Acquired Immune Deficiency Syndrome (AIDS) could, ac¬ cording to one theory, be transmitted in such fashion through a virus or bacteria attached to the ejaculate of an infected donor. Proper rectal hygiene, therefore, should be a matter of imperative necessity for any kind of ano-rectal sexual rapport.

It is known that the stool is a source of parasitic infections and should be thoroughly cleansed out from the ampulla before sexual relations while the semen from the active partner should be flushed out right after intercourse as a possible carrier of diseases to the passive party. Accordingly, to effectively ac¬ complish this objective, the key design criteria of any appropriate rectal douching device should be as follows:

1. Inexpensive and therefore diposable, in part or in whole, particularly in regards to the contaminatable nozzle section.

2. The nozzle should be safe, comfortable to insert and equipped with exit apertures situated in such a way that the pressure flow of the douching liquid is evenly distributed among the four cardinal points and oriented upward at a 30° to 50° angle in order to adequately drench the dome of the ampulla.

3. The structure of the device should allow the container of liquid to be easily and quickly refillable at least three times in fairly rapid succession.

4. The device should incorporate conveniently handable means of dispensing a variety of water-soluble medications.

Commercially available products for rectal douching have been found to be sparse and thoroughly lacking in terms of consumer convenience or medical safety or both. Reusable, flexible douching bags are cumbersome and can subject the user to the danger of infection or reinfection when unsuspected parasitic bacteria are present. On the other hand, ready-to-use, prefilled, disposable enema bottles are chiefly designed to provoke evacuation by chemically stimulating the sensory nerve endings of the colonic mucusa. The paristaltic reflexes so triggered, however, tend to last longer than intended which "make these, products unsuitable for the purpose of just rinsing out the ampulla.

Pertinent designs in the general body of prior patented art have been found to be equally lacking in suitability or even adaptability to the task of douching the ampulla. For example, U.S. Patent No. 1,602,215 features a water-soluble tablet of solid medication situated inside a reusable douche nozzle equipped with two separate rows of perforations: an upper series designed to allow the fluid to exit from the tip of the nozzle and a lower series at the base of the nozzle to channel the rinse-off flow out of the body cavity. U.S. Patent No. 2,507,214 covers a vaginal syringe equipped with a water-pressure control screw-valve acting also as a dispenser of liquid medica¬ tion. And U.S. Patent No. 2,596,597 relates to a syringe nozzle with manually rotatable spray orifices. While all of the foregoing devices are intended and designed for vaginal use, none incorporate the above-listed design criteria deemed essential for any effective rectal douching apparatus.

Disclosure of Invention

The present invention is designed to overcome the deficiencies of the prior art and to provide a device which accomplishes the objectives described above. This is achieved, according to the invention, by providing a prophylactic rectal douching device which includes a plastic squeeze bottle having a cap with an elongated nozzle mounted thereon and extending upwardly therefrom. The cap is divided into an upper portion and a lower portion and includes a living hinge between the two which allows the upper cap portion and nozzle to pivot out of the way to expose the open top of the bottle for refilling the same with tap water. This is done without having to remove the entire cap and nozzle from the bottle. A locking mechanism main¬ tains the upper cap portion and nozzle in their upright operable position during use. The nozzle includes a plurality of spaced apertures which are designed to dispense liquid from the bottle at optimal angles. Flow splitters within the nozzle equalize the flow rate and pressure among the various apertures. The nozzle is also adapted to carry a supply of medication which is intended to be added to the douching fluid.

Brief Description of Drawings For the purpose of illustrating the invention, there are shown in the accompanying drawings forms which are presently preferred; it being understood that the invention is not intended to be limited to the precise arrangements and instrumentalities shown. Figure 1 is a front elevational view of a pro¬ phylactic rectal douching device constructed in ac¬ cordance with the principles of the present invention; Figure 2 is a top plan view thereof;

Figure 3 is a vertical sectional view with the nozzle shown in phantom in its open position;

Figure 4 is a top plan view of the douching device with the nozzle in its open position;

Figure 5 is a cross-sectional view similar to

Figure 3 but showing a modified form of the invention; Figure 6 is a top plan view of the embodiment shown in Figure 5 with the nozzle in its open position;

Figure 7 is a cross-sectional view taken through the line 7-7 of Figure 5;

Figure 8 is a top plan view of the device prior to assembly for use;

Figure 9 is a vertical cross-sectional view of the device prior to assembly for use;

Figure 10 is a top plan view similar to Figure 8 but showing the same with a heat shrink film thereon for protection during shipping, and Figure 11 is a front elevational view of the device packaged for shipping.

Best Mode for Carrying Out the Invention

Referring now to the drawings in detail wherein like reference numerals have been used throughout the various figures to designate like elements, there is shown in Figure 1 a prophylactic rectal douching device constructed in accordance with the principles of the present invention and designated generally as 10. The douching device 10 is comprised essentially of three components: a squeezable plastic container 12, an an¬ atomically shaped nozzle 14 mounted on the container 12 and internal means (to be described more fully here¬ inafter) for storing and dispensing water-soluble med¬ ication into the douching solution. The container 12 is a thin-walled, easily squeez¬ able, blow-molded plastic bottle typically made from low to medium density polyethylene and/or polypropylene. Screwed thereon is a plastic unitary assembly comprised of the nozzle 14 and an internally threaded crown cap 16 which can be injection molded from polyvinylchloride, polystyrene, polypropylene, polyester or semi-flexible thermoplastic elastomers such as polyurethane.

One of the most important considerations governing the design of a rectal douching device is that it takes, on the average, from 20 to 30 fluid ounces to completely rinse out the stool from the ampulla. Since a container of reasonable size has to be used, preferably with a holding capacity of some 10 fluid ounces, two to three refills will be necessary. This requires a simple and quick way of exposing the open mouth of the con- tainer to a water faucet.

As shown most clearly in Figures 1-4, the crown cap 16 is a split structure comprising an upper cap portion 16a and a lower cap portion 16b. An integral living hinge 18 joins the upper and lower portions 16a and 16b along one side thereof. The hinge 18 is located at a level which is substantially equal to the uppermost edge of the rim of the bottle 12. As a result of the hinge 18, the upper super structure, that is, the upper cap portion 16a with the nozzle 14 attached thereto is able to tilt downwardly to expose the open mouth of the bottle 12 while the lower portion 16b of the cap 16 remains secured to the neck of the bottle 12. This is shown in phantom in Figure 3. The nozzle 14 and upper cap portion 16a are main¬ tained in their upright position by a locking means carried by the cap 16 located at a position remote from the hinge 18. The locking means is comprised of a ridge 20 which extends upwardly from the upper surface of the lower cap portion 16b. A complementary mating groove 22 is located in the lower surface of the upper cap portion 16a. The ridge 20 and groove 22 frictionally interact with each other to form the locking means. A simple pressure of the hand, however, opposite the hinge side of the nozzle 14 will quickly open access to the mouth of the container 12 for easily refilling the same with water.

Other important considerations in the configuration of rectal douching devices concern the direction of the sprays of the douching solution exiting from the nozzle and the pressure of the sprays. In view of the volumetric design of the ampulla which is shaped in the form of an elongated light bulb and in view of the fragility of the single layered lining of the rectal mucosa, the douching sprays should assume the pattern of an inverted cone and be directed upwardly around an arc of 30° to 50°. The pressure of the liquid forced out of the nozzle should be diffused as evenly as pos¬ sible through a plurality of channels leading to lateral exit slits rather than holes. Too high a water pressure forced through one single circular opening has been known to cause minute punctures in the rectal mucous membrane providing virus and bacteria with possible entry points into the blood stream.

In order to accomplish this and other features, the nozzle 14 is designed in the following manner. The upper portion 16a of the cap 16 is surmounted by a narrow, flat recess abutting a short circular ridge 24 forming therewith a shelf designed to keep the in¬ verted nozzle stabilized into the neck of the bottle during shipping as will be explained more fully here- inafter. The circular ridge 24 progressively tapers inwardly and upwardly as shown at 26 into a substantial¬ ly cylindrical shape to form the nozzle 14. At its base,- the nozzle 14 should have an outer diameter of approximately one inch in order to constitute a plug- like arrangement against the anal sphincter muscles to thereby prevent seepage of the liquid during douching.

Extending upwardly from the base of the nozzle

14 for about two inches, the nozzle diameter thins further down to about five-eighths to three-quarters of an inch in diameter to form a very soft shoulder 28 ringed with four exit slits 30 which are equidistant- ly arranged around the circumference of the nozzle. The nozzle 14 terminates in a rounded tip 32 which is provided with three apertures 34 equally spaced therearound.

Referring now to Figure 3, it can be seen that the internal arrangement of the nozzle 14 includes, adjacent its base, a flexible semi-spherical one-way valve 36 of unitary construction which prevents backflow and, to a degree, controls forward flow pressure. To this end, the valve 36 incorporates one or more expand¬ able slits across its top which may either be lateral or cross shaped. The valve is preferably made of such inert thermoplastic elastomeric materials as latex, neoprene or polyolefin rubber so that it can be heat- sealed or ultrasonically welded onto .the circular recess 38 provided therefor underneath the ridge 24.

The internal walls of the nozzle 14 extend upwardly from the circular recess 38 in a substantially cylindri¬ cal manner up to the level of the constriction created by the shoulder 28. At that point, the internal walls of the upper portion of the nozzle 14 thicken as shown at 40 to create, in effect, a circular sluice-like arrangement 42 having its base and the four cardinal exit slits 30 angulated at approximately 45° from the normal. As a result, the douching fluid forced out of the bottle is not only apportioned according to the diameter of the ducts in the lower and upper nozzle portions but is sprayed out at the desired angle. The same principle applies for the uppermost internal ar¬ rangement of the nozzle which incorporates an inverted cone 44 fanning the fluid out at the chosen angle through the apertures 34.

In the embodiment of the invention illustrated in Figures 6 and 7, the circular inner edge of the sluice wall 42 extends downwardly to form a substantial- ly cylindrical tube 46. This feature is designed to accomplish three primary functions. Firstly, in combina¬ tion with the four radially extending support walls 48, five separate channels are formed to equalize the douching fluid in the desired volumes. The five channels are comprised of the four channels 50 formed between the walls 48 and the ^"cylindrical wall 46 and the central duct or channel 52 within the cylindrical wall 46. Secondly, the wall 46 tends to diffuse the hydraulic pressure and lastly, it acts as a spacer for the car- tridge of medication 54.

The cylindrical wall 46 and radial support walls 48 are, of course, only one method for maintaining the cartridge 54 of medication in its proper position inside the base of the nozzle 14. The inside walls of the nozzle could also be provided with a plurality of short radially inwardly extending fins which would be positioned around the inside wall of the nozzle in a manner very similar to the radial support walls 48.

The present invention also provides a means for storing and dispensing unit-dose medications. Two dif- ferent methods are proposed according to the invention depending on the precision of the dosage required. The first method, which is the more precise one, is shown most clearly in Figures 8 and 9. It can be seen that the apparatus is provided with a small con- tainer 56 comprised of a thermoformed plastic material and which is filled with a liquid, solid or powdered concentrate 58 of any appropriate medicated solution to be diluted or dissolved into the water contents of the bottle 12 prior to use. In the interest of space saving in shipping and packaging, the size and shape of the container 56 are chosen so that the container is designed to fit snuggly into the empty cavity available at the base of the nozzle 14 in the area substantially surrounded by the cap 16. The "piggy-back" container 56 of medication .58 can also be shaped to provide two or more separate cavities. Each cavity could be filled with a separate medication which can either be mixed together in one application or which may be intended to be used in sequence.

A more convenient but less precise delivery mode for a medication is shown in Figure 5. As pointed out above, a cartridge 54 of medication can be inserted into the base of the nozzle. The cartridge 54 is prefer- ably cylindrically shaped and may be made of a plastic cellular material such as polyurethane foam impregnated with a variety of partially dehydrated, water soluble ingredients in various concentrations. These ingre¬ dients, deposited in film form around the cells of the foam structure, are designed to allow the fluid to flow through and to spontaneously dissolve on contact with water or any other aqueous substances.

The dissolution of the ingredients from the car¬ tridge 54 can be speeded up by increasing the surface exposure of the cellular carrier to the liquid medium by providing the cartridge with a plurality of longi- tudinal channels 60 and 62. As shown most clearly in Figures 5 and 7, these channels can assume various depths, widths or cross-sectional shapes and can be situated laterally or internally or both. The length of the cartridge 54 can vary according to cell sizes, concentration and solubility rate of the additives and release requirements of the ingredients in the exiting douching fluid.

In addition to cellulose, various foamable polymers and co-polymers can be utilized to produce the cellular foam cartridge 54. By way of example and not limitation, material such as foam rubber, polyvinylchloride, poly- vinylacetate, polypropylene, polyethylene, polyester polyurethane and polyether polyurethane can be used. Of these materials, the latter is the preferred material in view of its good hydrophilic properties combined with flexibility in cell size formation and high- addi¬ tive-handling capacity. Desirably, the foam density should range from about 1 to 1.8 pounds per cubic foot (excluding the weight of the additives) with average cell sizes ranging from 3.5 to 8 millimeters.

When utilizing polyether polyurethane, the car¬ tridge 54 of cellular foam can be manufactured and impregnated with medicated additives in at least two different ways. In the first method, a grooved cylinder of appropriate diameter can be machined from a block of cured, reticulated polyurethane foam utilizing a hot knife. The cylinder can then be dipped into a bath containing the liquid medications for saturation and subsequently dried out. The cylinder can then be cut into appropriate lengths unless it had been precut. With this multi-staged, post-impregnation process, the percentage of additives for release can usually amount only to a practical maximum of about 15 percent by weight of foam.

A second method for manufacturing and impregnating the cartridge 54 consists of admixing with the partially foamed polymers the various medicated additives to be released in the douching liquid. This single step process has the advantage of bypassing the time-consum¬ ing machining steps by delivering straight from the mold a finished, ready-to-use preimpregnated cartridge with a porous membranous skin. The use of this tech¬ nology, based upon the teachings of Patent 4,271,272, allows the cellular cartridge to hold up to about 60 percent by weight of water soluble additives for release. The medicated additives contained in the cartridge 54 or the container 56 should desirably contain a com¬ bination of non-irritating ingredients, not only for the effective removal of the stool but also to help restore to normal the very delicate membrane of - the ampulla. Ideally, the composition of the medicated douching solution should combine the following six generic ingredients:

1. An emollient such as mineral oil, vegetable glycerin or lanolin.

2. A mild surfactant such as cocoa-tallow "baby soap. "

3. A pH stabilizer.

4. Healing agents such as vitamins C and E in combination with Zinc or extracts from any nu ber of appropriate medicinal herbs such as Hypericum (Hypericum Perforatum) , Arnica (Arnica Montana), Aesculus (Aesculus Hippo- castanum) , Comfrey (Symphytum Officinale) , Balsam (Graphalium Polycephalum) or Marigold

(Calendula Officinalis) .

5. Astringents derived from any of the following herbs: Aloe Vera (Trillium Purpureum) , Balmony (Chelone Glabra) , Shepherd's Purse (Capsella Bursa-Pastoris) , Witch Hazel (Hammanelis Vir- ginica)^' or Alum Root (Geranium Maculatum) .

6. A natural blood clotting herbal agent extracted from Matico (Piper Augustifolium) or Yarrow (Achillea Millefolium) .

In order to reduce the assembled douching device 10 to a more manageable and compact size for shipping, the structure of the lower portion of the nozzle 16 is so designed that it can fit snuggly upside down into the bottle 12 as shown in Figures 9 and 10. It can be seen that the shape of the ridge 24 is selected so that it fits into the opening at the top of the bottle with the top edge of the bottle contacting the cap 16.

For the protection of the consumer, the base of the inverted cap 16 including the container 56 with medication 58 therein and the upper end of the bottle 12 are shielded during shipping and handling by means of a tamper-proof thermo-plastic heat shrinkable film 64. In addition to providing protection, the film 64 also maintains the cap 16 and nozzle 14 into proper orientation with the bottle 12. To open the assembly, the tear strip 66 of the shrink film 64 is used to rip open the protective film 64 and free the nozzle 14 for assembly onto the bottle 12. The container 56 of medication 58 may also be provided with its own cover in the form of a peel-off seal 68. Prior to fill¬ ing the bottle 12 with water, the contents from the container 56 may be poured therein to be mixed therewith and the container 56 can then be disposed of.

As shown in Figure 9, the tip 32 of the nozzle 14 is also provided with its own supply of lubricant 70 which is held in place by a thin, flexible tubular mating plastic sleeve 72 press fitted or otherwise attached thereon during shipping. When the sleeve 72 is removed prior to inserting the nozzle for douching, a coating of lubrication 70 will be left on the tip of the nozzle. This process can be repeated prior to reinsertion by redipping the nozzle back into the sleeve of lubricant.

Desirable properties of the vegetable oil based lubricant 70 should primarily be high viscosity, re¬ sistant to body temperature and water solubility. In addition, the lubricant may be medicated and incorporate a number of appropriate topical wound healing agents and astringents such as those listed above for the douching solutions as well as a mild topical anesthetic such as Procaine, Benzocaine or Lidocaine. The anes¬ thetic should be chosen to selectively desensitize to some degree the pain conductive nerve endings of the anal sphincter without unduly affecting those which transmit sensations.

The present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof and accordingly, reference should be made to the appended claims rather than to the foregoing specification as indicating the scope of the invention.

Claims

1. A prophylactic rectal douching device comprising: a semi-rigid plastic squeeze bottle adapted to contain a quantity of a liquid douching solution; a cap means, said cap means having an upper portion and a lower portion, said lower portion including means for securing said cap means to the top open end of said bottle; an elongated nozzle means carried by the upper portion of said cap means and extending upwardly there¬ from; hinge means located between the upper and lower portions of said cap so that the upper portion along with the nozzle means carried thereby can be pivoted away from the lower portion to provide access to the interior of said bottle, and locking means for inhibiting . pivotal , movement between said upper and lower portions^': ^* •

2. The device as claimed in Claim 1 wherein said nozzle means includes a plurality of apertures therein through which douching fluid can pass.

3. The device as claimed in Claim 2 wherein some of said apertures are located adjacent the upper end of said nozzle means and others of said apertures are located intermediate the upper and lower ends of said nozzle means.

4. The device as claimed in Claim 3 wherein said inter¬ mediately located apertures are in the form of slits and are designed to direct liquid from said nozzle means at an angle of between approximately 30° to 50° from the axis of said nozzle means.

5. The device as claimed in Claim 3 further including flow separating means within said nozzle means for separating the liquid entering said nozzle means from said bottle into a plurality of different streams.

6. The device as claimed in Claim 1 including means located within said nozzle means for holding a quantity of medication to be added to the douching fluid.

7. The device as claimed in Claim 6 wherein said medi¬ cation holding means is in the form of a cartridge which dispenses medication into the douching fluid as the fluid is dispensed from said device.

8. The device as claimed in Claim 7 wherein said car¬ tridge is comprised of a cellular foam material with said medication impregnated therein.

9. The device as claimed in Claim 1 further including a one-way valve within said nozzle means.

10. The device as claimed in Claim 1 further including means for lubricating the outer surface of at least the upper portion of said nozzle means.

11. A composition for use as a rectal douche comprising effective amounts of: an emollient; a mild surfactant; a pH stabilizer; a healing agent; an astringent, and a blood clotting agent.