Dispensing container for medical foams

were: US-PS 2511469

- 2 No. 356799

The invention relates to a device for introducing an aqueous solution of at least one medicament or the like. in a body cavity, consisting of an elongated container provided with an elastic portion, which in the region of one end is associated with a one-way valve and which is provided at its other end with a discharge opening.

Medications to be delivered into the colon are usually administered via the rectum or a colon opening in the form of a suppository or enema syringe. When administered by suppository, the drugs only reach the end of the colon and are only absorbed there, so this method is unsatisfactory if the drug is to continue to penetrate the colon. Using enema syringes, the drug continues to penetrate into the colon, with the depth of penetration depending, of course, on the volume of fluid used. In adults, the colon is about 1.5 meters long and has a capacity of nearly 2.5 liters, so that a considerable volume is required to completely fill the colon. Even only the filling of the distal part requires a large volume of fluid. There are two main types of enema syringes, namely those which are administered by gravity through a cannula using large volumes of fluid and those which are readily available and are used with a relatively small volume of fluid. In order to stimulate the peristalsis of the large intestine, about 550 to 850 ml 5% greases solution are used, whereas with the last-mentioned enema single doses with a plastic bag which is provided with a rectal tube and about 100 to 150 ml of a solution, such as peanut oil, Magnesium sulfate, or sodium phosphate, can be administered. It is obvious that in both types of enema syringes, if there is a requirement,

From US-PS No. 2,511,469 a device is known, which consists of an elongated elastic container, at both ends of which a one-way valve is connected, wherein the one valve is provided with a supply hose for a liquid and the other valve with a discharge opening which can be inserted into a body opening.

This known device functions as a pump, ie, by repeatedly squeezing and releasing the elastic container, liquid is pumped from a reservoir through the hose and the elastic container through the discharge port.

The disadvantage of this known device is that it consists of two parts, namely the pump and the reservoir, which must be joined together before start-up of the device by means of hose connections and are also not sterile sealed.

The object of the invention is to provide a device of the input outlined type, in which the mentioned disadvantages are avoided.

This object is achieved in that the container is provided in the areas of its two ends with hermetically sealing on breakable closures, wherein the one-way valve can be placed on the container in the region of one of its ends.

The device is particularly suitable for administration of a medicinal agent in the form of a foam into the vagina or into the colon through the anus or through a large intestine opening.

Suitable plastics from which the device can be made are high density polyethylene, polypropylene, polyphenyl chloride, copolymers of ethylene with his to 12% phenyl acetate, and preferably low density polyethylene. Preferably, the container has a flat or serrated cylindrical shape which is deformable upon application of an external pressure, such as squeezing, and which has an elasticity such that it returns to its original shape after deformation. Preferably, the two ends are stiffer than the portion of the container located therebetween.

Each closure may be in the form of an insertable and removable plug or cap. Preferably, however, each of the two ends of the container is closed by means of a breakable diaphragm. This ensures a high degree of sterility within the container.

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In accordance with an advantageous embodiment, the one-way valve is provided with an internal projection and a cutting edge disposed thereon to allow penetration of the diaphragm home on the one-way valve to the container.

The one-way valve may be made of plastic, such as polystyrene, and to the

Device as a sealing on stretchable part or preferably with a screw thread part, which cooperates with a coplanar part of the device, be connectable.

In order to use the device for introducing an aqueous agent in the form of a foam into a body cavity, it is partially sealed (approximately up to a quarter) with an aqueous agent consisting of, for example, a medicament or an X-ray contrast agent, prior to sealing Foaming agent and a foam stabilizer filled.

Further features and advantages of the invention will become apparent from the following illustrative description of the embodiments illustrated in the drawings, in which: Fig. 1 is a side view of a device for introducing a medical device in the form of a foam into a colon opening suitable for connection to an attachable one Fig. 2 is an enlarged fragmentary view of the apparatus of Fig. 1, showing the change in wall thickness to provide suitable rigidity of the discharge end and compliance of the main body of the apparatus. Fig. 3 is an enlarged fragmentary view of Fig. 1 FIG. 4 shows a partial sectional view of the closed one-way valve according to FIG. 3, FIG.Figure 5 is a side elevational view of a second device for use in a colon opening which may be connected to a one-way screw-on valve; Figure 6 is an enlarged fragmentary view of the second device showing the connected valve, but with the air inlet seal intact; .7 an enlarged partial view of the second device with connected

Valve shows, but with the closure for the air inlet is pierced.

As shown in FIGS. 1-4, the apparatus preferably consists of an elongated container formed of low density polyethylene or similar plastic, such as an ethylene / phenyl acetate copolymer, and a deformable cylindrical body elastic portion -1- and ends -2 and 3 - Has, whose wall thickness is greater than that of the center body, so that the ends have a greater dimensional stability. The discharge end -2- has a Schul- terteil -4-, which is shaped so that a good sealing contact is achieved when the device is connected to a colon opening, further, the end has a neck -5-, which the discharge opening -6 - limited, which is closed by a closure -7-, which is connected to the neck -5- via a peripheral weak zone with reduced wall thickness -8-. The closure -7- is seen with means, preferably in the form of wings -7a ver35, by means of which the closure can be detected and twisted to break off the said weak zone. The second end -3- has a neck -9-, which delimits an air inlet opening -10-, which is closed by a closure -11-, which is connected at the neck -9- via a peripheral weak zone with reduced wall thickness. Also this closure -11- is provided with means, preferably in the form of wings -11a, by means of which the closure can be detected and twisted to break the weak zone. by means of which the shutter can be detected and twisted to cancel the mentioned weak zone. The second end -3- has a neck -9-, which delimits an air inlet opening -10-, which is closed by a closure -11-, which is connected at the neck -9- via a peripheral weak zone with reduced wall thickness. Also this closure -11- is provided with means, preferably in the form of wings -11a, by means of which the closure can be detected and twisted to break the weak zone. by means of which the shutter can be detected and twisted to cancel the mentioned weak zone. The second end -3- has a neck -9-, which delimits an air inlet opening -10-, which is closed by a closure -11-, which is connected at the neck -9- via a peripheral weak zone with reduced wall thickness. Also this closure -11- is provided with means, preferably in the form of wings -11a, by means of which the closure can be detected and twisted to break the weak zone.

In order to be able to connect an expandable one-way valve after the closure of the closure -11-, the neck -9- with two sealing rings -12- in the form of annular projections and an annular retaining ring -13- is provided, which a seal and a holder for a clip-on Form one-way valve, as shown in Figures 3 and 4 and in the GB-PS

No. 835,507.

The apparatus may be molded, partially filled with an aqueous medium and then hermetically sealed, which operations are preferably aseptic in a single machine such as a form, fill and seal machine of the type described in British Patent No. 1,041,548 Conditions can be made.

To introduce a foamed enema into a colon opening has a suitable

Container has an inner filling space of about 200 ml and receives about 30 to 50 ml of an aqueous foamable agent.

When using the device, it is shaken to form the foam,

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- 4 after which the shutter -11-, as described turned off and the one-way valve is connected. Then, the shutter -7- is turned off in the manner described above, leaving any sharp-edged shape of the peripheral zone of the weak spot within the neck -5-, so that when the neck is then inserted into the opening, the colon wall can not be damaged , The container is then compressed to deliver the foam to the colon, the one-way valve serving to minimize the foam exit through the air inlet port. Upon completion of the squeezing, the walls of the container begin to return to their original undeformed shape, the device still being pressed against the colon so that a partial vacuum builds up in the device, which causes an opening of the one-way valve and allows the entry of air. The cycle of squeezing and re-inflation is repeated until a suitable amount of foam is expressed. In order to cause the foam to further penetrate into the colon, the aforementioned cycle may be further repeated so that air is injected into the large intestine.

FIGS. 5 to 7 show a second embodiment of a device according to the invention. The device shown in Figure 5 differs from the device according to Fig.l with respect to the structural design of the second end. The second end -3- has a neck -20-, which defines an opening which is closed by a rupturable diaphragm -21-, wherein on the outside of the neck, a threaded portion -22- is provided.

The valve -23- has an open end -24- defining a recess internally threaded - 25-- for screwing onto the threaded portion -22- of the neck of the device, the recess further having a projection with a cutting edge Is provided so that when screwing the valve on the neck of the container a cutting edge -26- the breakable diaphragm -21- pierces. The valve has above the recess a chamber -27-, which is connected via channels -28- with the recess and with an air inlet, wherein a valve member -29- is located within the chamber. The valve member, which is provided on its underside with stops -30-, can due to the influence of the fluctuating air pressure at the top and at the bottom of the valve member between an open position (in FIG. 6 and 7), which allows the admission of air, and a closed position, which blocks or minimizes the air inlet through the air inlet. (In a modified construction, the bottom of the valve member -29- is flat and the top of the chamber -27- provided with stops against which the valve part in the open position.) Conveniently, the parts of the valve made of plastic, such as polystyrene pressed parts.

At the time of use, the device is shaken to form foam, the valve is screwed onto the neck of the device with the cutting edge piercing the diaphragm, and the shutter -7- (see Fig. 2) is turned off, followed by further processing as described above.

Preferably, the neck of the device may be provided with an annular bead 31 and the valve with a ring 32 protruding inside the open end, so that when the valve is initially screwed onto the device, the annular one may be provided Bump -31- abuts against the ring -32-, with the cutting edges -26- from the diaphragm -21- be held away. The device can then be packaged together with the valve, which is already screwed in the manner described above. As a result, when the valve is further rotated with respect to the device, the ring -32- moves beyond the annular bead -31- and the cutting edge -26- passes to the diaphragm -21- to then pierce it.

The penetrable diaphragm may be provided with a shallow recess 33, so that when the valve is screwed onto the neck of the container and the cutting edge 26 pierces the diaphragm, the base of the recess is not cut and therefore the cut-away portion -34- of the diaphragm can not fall into the device to possibly block the discharge port -6- (see Figure 2). Preferably, the discharge port -6- is smaller than the cut -34 part, so that when the latter has been completely separated, it can not enter the body through the discharge port.

- 5 No.356799

The two embodiments described above are suitable for use on the colon via a colon opening, but for use on the anus, the discharge end is longer. It is obvious that the device described above for use in human treatment can also be applied to animals.

As already mentioned, an aqueous agent used in the device may consist of a drug or an X-ray contrast agent, a foaming agent and a foam stabilizer. In order to minimize any irritation of the large intestine, the means which are to be introduced into the large intestine, preferably on a p_RValue of 7 may be buffered by the addition of a suitable buffering system such as tris (hydroxymethyl) 10-methylamine and sodium citrate.

For the purpose of assisting defecation, a medicament consists of at least one compound having a laxative effect, such as dioctyl sodium sulfosuccinate, an alkali or alkaline earth metal phosphate, a bisacodyl, oxyphenation or an anthraquinone derivative.

For the treatment of ulcerative colitis, the medicament contains at least one compound, such as a corticosteroid, with antiinflammatory activity, such as prednisolone, hydrocortisone or betamethasone, or their esters or salts.

Other types of drugs that are commonly administered via the colon include lical anesthetics such as lignocaine, sedatives such as chlorpromazine hydrochloride, bronchodilators such as aminophylline, and analgesics such as pentazocine.

Suitable x-ray contrast agents are barium sulfate and polyiodo-styrenic resin.

The foaming agent is to be selected from those soaps and detergents which are pharmaceutically acceptable when used for a body cavity such as the colon or vagina. Examples of such materials are sodium lauryl sulfate and cetrimide. There are drugs such as dioctyl sodium sulfosuccinate, which also act as foaming agents, so that in these cases it is not necessary to have another

Add foaming agent.

In order to obtain the foam after its formation, the composition further contains a foam stabilizer such as coconut diethanolamine or hydroxypropylmethyl cellulose.

Preferably, the aqueous composition contains a preservative, such as methyl or propyl p-hydroxybenzoate.

With this device, when administering a medicament in the form of a foam, a smaller volume of fluid is used than with conventional enemas, and as a result, the frequency of premature leakage from the colon is greatly reduced. Furthermore, the foam continues to enter the large intestine.

In the following, examples of formulations are given which can be introduced into the large intestine using the device according to the invention.

Example 1: Laxative

dioctyl sodium

hydroxypropyl methylcellulose

Methyl-p-hydroxybenzoate

water

1.0 g 1.3 g 0.15 g ad 100.00 ml

Example 2: Buffered laxative

Dioctylsulphosuccinate 1.0 g

Hydroxypropylmethylcellulose 1.3 g

Methyl p-hydroxybenzoate 0.15 g

Tris (hydroxymethyl) methylamine 0.15 g

Sodium citrate monohydrate 0.08 g

Water ad 100.00 ml

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Example 3: Formulation for ulcerative colitis

Prednisolone sodium phosphate 0.054 g added to the formulation according to Example 2

Example 4: X-ray contrast agent

Barium sulfate 60.0 g added to the formulation according to Example 2.