WO2011157423A1

WO2011157423A1 - Medical tampon

Info

Publication number: WO2011157423A1
Application number: PCT/EP2011/002969
Authority: WO
Inventors: Irene Burger
Original assignee: University Of Zurich
Priority date: 2010-06-18
Filing date: 2011-06-16
Publication date: 2011-12-22

Abstract

The invention relates to a cylindrical absorbent hygiene article for women for insertion into the vagina for the absorption of the liquid from menstruation (tampon), consisting of a homogeneously and substantially non-sheathed absorption body, in which the end directed toward the vaginal opening is water repellent and prevents absorption of urine during micturition. In addition, the invention relates to uses of the tampon according to the invention for avoiding contamination of the vaginal region by urine absorption in the tampon, in particular for avoiding contamination by radioactive tracer substances and/or microorganisms. The invention also relates to corresponding methods for producing the tampons.

Description

Medical tampon

The present invention relates to cylindrical absorbent feminine hygiene articles for insertion into the vagina for receiving the liquid of menstruation (tampon), consisting of a homogeneous and largely unencapsulated Absorbtionskörper in which the vaginal opening directed end is water repellent and a recording of urine in the Voiding prevented. In addition, the invention is directed to uses of the inventive tampons to prevent contamination of the vaginal area by urine absorption in the tampon, in particular to avoid

Contaminations by radioactive tracers and / or microorganisms. The invention also relates to corresponding production processes for the tampons.

In the PET-CT examination of women with menstrual bleeding, for example, with the tracer F ¹⁸ - FDG, there is often an accumulation of the tracer in the tampon. This enrichment can interfere with the diagnosis of genital tumors, especially in the study of uterine cancer. Therefore, women with menstrual bleeding should remove the tampon before each PET-CT to avoid such disorders. The cause of the accumulation of the tracer just in the tampon has not been investigated and is associated with the blood uptake, since in menstruating women a Tracer- accumulation can be detected in the lumen of the uterus.

Antibiotic coated tampons are known to reduce the risk of infection during menstrual bleeding.

US Pat. No. 3,796,219 describes tampons provided with a water-soluble, thermoplastic and film-forming polymer coating with plasticizer component, preferably of a hydroxypropylcellulose polymer and with an olefinic glycol such as propylene glycol or polyethylene glycol as plasticizer for ease of introduction into the vagina.

US Pat. No. 4,952,211 discloses a reduced fiber release pad on the surface of which a coating of beeswax is so finely dispersed that fluid permeability is ensured, but loose or dissolved fibers are not

can be transported together with bacteria from the vagina to the uterus.

CONFIRMATION COPY US Patent 4,374,522 is directed to a tampon having a cylindrical cavity across the length of the tampon, which is delimited to the inner end by the tampon material, outwardly through a liquid-impermeable, flat lid. The cavity serves as a storage space and the liquid-impermeable flat lid prevents leakage of the stored body fluid from the vagina.

Furthermore, tampons are known in which the absorbent material is held together with liquid-permeable sheaths, which may also be stretchable to accommodate the expansion of Absorbtionsmaterials. These wrapped tampons are also referred to as "bag type tampons".

US Patent Application 2002/0142693 A1 discloses a fully jacketed tampon in which only the inwardly directed liquid pervious and the outwardly directed portion constitutes a liquid impermeable barrier which prevents leakage of the tampon to the outside.

It is the object of the present invention to provide means and methods which, in the computed tomography of tampon-bearing women by means of radioactive tracers, avoid accumulation of these in the tampon and thus a disturbance in the investigation of physiological and biochemical changes in the genital area of women. Another object of the invention is to provide means and methods for preventing vaginal contamination with microorganisms.

This object is achieved by means of a cylindrical absorbent feminine hygiene article for insertion into the vagina for receiving the liquid of menstruation (tampon), consisting of a homogeneous and largely unencapsulated Absorbtionskörper in which the vaginal opening (basal) end facing water repellent and a Uptake of urine during urination (essentially, ie more than 50,

preferably more than 70 or 80, more preferably more than 90 and most preferably 100%).

A "homogeneous absorption body" in the sense of the invention is to be understood as meaning that the body consists of homogeneously distributed absorption material, optionally in a support matrix homogeneously distributed over the absorption body

Absorbtionskörper no coherent cavity, the more than 5,

preferably more than 10, more preferably more than 20 volume percent of the total Absorbent body in the dry state. Preferably, the homogeneous body consists of a single homogeneously distributed Absorbtionsmaterial, but may also consist of several homogeneously distributed Absorbtionsmaterialien and optionally other homogeneously distributed therein materials such as supporting materials.

The term "largely uncoated" means that the absorbent body is contiguously coated with less than 50, preferably 30, more preferably 20, most preferably 10 percent of its outer surface

To understand absorption body.

It was surprising bearing in a study of more than twenty tampon women who were examined by F ¹⁸ FDG PET-CT demonstrated that the radioactive

Contamination of the tampons by the contact of the urine jet with the vaginal opening (basal) directed end comes about. Insertion of the tampon only in the outer, steeper section of the vagina may result in the vaginal opening being no longer completely closed and the tampon end being able to come into contact with urine. Because of the good Absorbtionsvermögens the tampon material, the recorded amount of tracer is suitable to affect the evaluation of PET-CT. In the

In this study, 35 percent of the 20 patients had tracer contamination without any menstruation, regardless of age or BMI (body mass index). In addition, in all FDG-positive tampons increased

Creatinine are measured. Therefore, it is in tracer accumulation of F ¹⁸ - FDG in the tampon not recorded blood, but a urine contamination.

The water-repellent end of the tampon according to the invention is preferably made water-repellent by hydrophobic coating. Materials suitable for this purpose are, in particular, synthetic, natural or semisynthetic polymers which are suitable for contact with the skin and mucosa, for example those for hygiene products such as diapers, surgical gloves and condoms. Particularly suitable are polymeric materials such as polyethylene, polypropylene, polystyrene, polyvinyl alcohol, polylactic acid, poly (3-hydroxybutyric acid), synthetic or natural rubber / rubber and

Combinations of it. Preferably, the materials are elastic and / or

thermoplastic. Particularly preferred are natural and synthetic silicone polymers. As an alternative or in addition to the hydrophobic coating, the water-repellent end of the tampon according to the invention can be closed by a hydrophobic cover, for example a hood, a cap or a lid. The term water-repellent cover in the sense of the present invention also means a water-repellent (eg cylindrical) attachment on the end of the tampon facing the vaginal opening (basal), which adjoins the tampon, so to speak a tampon with "outer stopper" Covers are provided which partially enclose the tampon at the end and extend beyond the tampon end, so to speak as a cap with an attachment.The cover may be firmly attached to the tampon end, eg glued directly to the tampon material or to the hydrophobic coating For example, the cover may be elastic and pulled over the tampon end under tension.

The cover can be placed and / or glued positively during manufacture on the tampon. Alternatively and preferably, the cap is placed by the consumer when needed on the tampon end and the contact is ensured by gluing and / or positive locking.

In a preferred embodiment, the present invention relates to such tampons, in which the hydrophobic cover on the vaginal opening (basal) directed end of the tampon is substantially form-fitting manner. If the cover placed on the tampon does not sufficiently hold on the tampon by positive locking during use, it should be additionally or alternatively glued, of course with a water-resistant adhesive. With this positive or bonded cover conventional tampons can be transferred quickly and easily into tampons according to the invention. Since tampons are mass-produced and the production of a very small amount for medical PET-CT applications may not be economical, the separate production and commercialization of hydrophobic is

Covers for tampons probably more economical.

Tampons usually have a thread at the end facing outward, which greatly facilitates the handling, in particular the removal after use. In a preferred embodiment, the tampons according to the invention also have at least one thread or a similar gripping device on the hydrophobic end of the tampon directed towards the vaginal opening. If, for the production of a tampon according to the invention, a hydrophobic cover is placed on the vaginal opening (basal) of a conventional tampon, the thread which is probably present is covered. Preferably, this thread is passed through a possibly existing small hole at the closed end of the cover. The problem is that the hole must be small so that little or no urine can penetrate to the tampon. More preferably, therefore, that the hydrophobic cover already has at least one thread or a similar gripping device at the closed end of the cover on which or on which the tampon can be pulled out after use.

Tampons usually expand in the course of fluid intake. Either the hydrophobic coating or the hydrophobic cover prevents expansion in the covered area or it expands together with the tampon in the covered area

Fluid intake off.

In a preferred embodiment, the tampon according to the invention is such that the hydrophobic end is extensible.

Commercially available tampons are about 3 to 8, usually about 5 cm long. With correct intravaginal placement, the tampon should be completely closed in the vagina, the introitus. However, due to use or imperfect placement, the tampon may continue to slide downwards towards the introitus. This is noticed only when a

substantial portion of the tampon is at the level of the introitus. In 40% of the inserted tampons, however, one end of the tampon, which is close to the introitus, is sufficient to contact the urine stream and to take up urine. Thus, only a small part of the outer end must be water-repellent coated or protected with a cover. 1 to 1.5 cm, as demonstrated by a proof of concepf study. Since the menstrual fluid in any case flows from the uterus to the tampon, which is enclosed by the vagina, it is sufficient if the upper 2/3 of the

Tampons are absorbent and forward the liquid in the tampon. This also makes better use of the storage capacity under the hydrophobic coating or the hydrophobic cover.

In a preferred embodiment, the invention relates to a tampon in which less than 50, preferably less than 30, most preferably less than 20% or Also less than 10 percent of the length of the tampon are water repellent. Based on a tampon of 5 cm length would therefore preferably 2.5 to 1 cm water repellent. But the invention also includes such tampons in which only the

Outside water repellent and those in which up to half of the tampon is water repellent, as long as in the latter case, a required fluid intake is given.

The tampon according to the invention can be supplied to the consumer as a ready-to-use product, i. as a tampon with a water-repellent coating or cover for placement on the directed to the vaginal opening end of the tampon, wherein in the case of the variant with cover this is firmly connected to the tampon.

Preferably, the tampon according to the invention is supplied in two parts, i. as a tampon and a water-repellent cover for placement on the vaginal (basal) end of the tampon, wherein the cover is firmly connected to the tampon.

In this sense, the present invention comprises a sanitary article system for women, comprising a tampon and a water-repellent cover for placing on the vaginal (basal) end of the tampon, wherein the cover with the tampon can be firmly connected, for example by positive engagement, adhesive and / or retaining ring.

In a further aspect, the present invention relates to the use of a water-repellent coating and / or cover for producing a

according to the invention sanitary article (tampons) or hygiene article system.

In another preferred embodiment, the invention is directed to the use of a sanitary article or sanitary article system of the invention for preventing the uptake of urine into the vaginal area during urination.

The use of the sanitary article or sanitary article systems of the invention is particularly advantageous for preventing vaginal contamination when the urine is contaminated with at least one tracer substance for computed tomography, preferably a radioactive tracer substance, more preferably ¹⁸ F-fluorodeoxyglucose. The use of the hygiene articles or sanitary article systems of the invention is also particularly advantageous for preventing vaginal impurities when the urine is more preferred with at least one microorganism, preferably a pathogenic microorganism, preferably selected from bacteria, fungi, yeasts and viruses

Bacteria, is loaded.

The urine of healthy people is essentially sterile, but not more when it comes in contact with the vulvar epithelium. Therefore, germs of the vulvar epithelium with the urine can be carried into the tampon, even if there is no infection of the kidney / bladder.

Furthermore, the tampons according to the invention not only prevent contamination but also the discomfort associated with wetness and odor.

In an additional aspect, the invention is directed to a method of making a sanitary article or sanitary article system of the invention, comprising the steps of:

(i) providing a cylindrical absorbent article suitable for use as a feminine hygiene article for insertion into the vagina for receiving the tidal fluid (tampon), consisting of a homogeneous and largely uncoated absorbent body, and

(ii) coating at least the vaginal (basal) end of the vaginal opening

Tampons, and / or

(iii) Connecting the vaginal (basal) end with a waterproof cover.

In the following the invention will be explained with reference to a non-limiting example to be interpreted.

example

On a commercial tampon of about 5 cm in length at the end directed to the vaginal opening an elastic plastic hood is placed, for example, an end of a small rubber balloon or the tip of a rubber or silicone condom, ie the small protuberance at the end to receive the sperm, so this cover covering about 0.5 to 3 cm, preferably 1 to 2 cm of the tampon water repellent. The inner one Diameter of the hood-shaped cover should be smaller than the pad diameter and elastic, so that the cover is preferably positively and firmly seated. If the fit and the elasticity is not enough, so the cover can be glued to the tampon with a suitable adhesive or possibly with rubber band or

Clamp (s) are secured. It is also important that a tensile holding device for removing the tampon is present. For example, the thread usually present at the end of the tampon can be led out through a small hole in the cover.

Alternatively, a silicone or latex composition can be sprayed or painted onto the end of a tampon facing the vaginal opening so that this coating covers about 0.5 to 3 cm, preferably 1 to 2 cm of the tampon in a water-repellent manner. If necessary, the coating should be stabilized against ripping, so that tearing caused by absorption of regular liquid can be prevented when the tampon expands. Alternatively, if necessary, the placement of a small elastic rubber ring in the coated area, which prevents a problematic expansion in the coated area is sufficient.

Another alternative is to set up or replace the last one, e.g. 1 to 2 centimeters of the tampon directed to the vaginal opening by means of a water-repellent

Zylinderstopfens with approximately the diameter of the tampon, which is also a water-repellent cover of the tampon in the context of the invention (tampon with "outer plug").

A woman with menstrual bleeding scheduled for FDG-PET-CT (with ¹⁸ F-fluorodeoxyglucose as tracer) receives one of the tampons prepared as above after intravenous administration but before PET-CT of the ovaries, fallopian tubes, uterus and bladder. If she has to urinate again before the PET-CT, so does the

Water-repellent coating or cover sure that the vaginal area is not contaminated with tracer, since the water-repellent coating and / or cover prevents penetration into the tampon and thus into the vagina.

A woman with pathogenic infection of the kidney (s), the bladder and / or the urinary tract receives one of the tampons prepared as above to prevent infection of the

Reproductive organs.

Claims

claims

1. Cylindrical absorbent feminine hygiene article for insertion into the vagina for receiving the liquid of menstruation (tampon), consisting of a homogeneous and largely uncoated absorbent body, characterized in that the end directed to the vaginal opening is water-repellent and a recording of urine in the Voiding prevented.

2. Hygiene article according to claim 1, characterized in that the

water-repellent end is hydrophobic coated. (by coating)

3. Hygiene article according to claim 1, characterized in that the water-repellent end is terminated by a hydrophobic cover (by covering)

4. Hygiene article according to claim 3, characterized in that the hydrophobic

Cover (hood) on the directed to the vaginal opening end of the tampon is substantially form-fitting placed. (as a hood, for example, on conventional

Tampons can be placed)

5. Hygiene article according to one of claims 1 to 4, characterized in that the hydrophobic end is stretchable. (when the tampon fills, the hood will stretch))

Sanitary article according to one of claims 1 to 5, characterized in that less than 50, preferably less than 30, more preferably less than 20, most preferably less than 10 percent of the length of the hygiene article

are water repellent.

7. Hygiene article system for women, comprising a cylindrical absorbent

Feminine hygiene products for insertion into the vagina for receiving the fluid of a menstrual period (tampon) and a water-repellent cover (hood) for placement on the end of the tampon facing the vaginal opening, the cover being firmly connected to the tampon.

8. Use of a water-repellent coating and / or cover for the production of a hygiene article or a hygiene article system according to one of claims 1 to 7.

9. Use of a hygiene article according to any one of claims 1 to 6 or a hygiene article system according to claim 7 for avoiding the uptake of urine into the vaginal area during urination.

Use according to claim 9 for preventing vaginal contamination with at least one tracer substance for computed tomography, preferably a radioactive tracer substance, more preferably ¹⁸ F-fluorodeoxyglucose.

Use according to claim 9 for the prevention of vaginal contamination with at least one microorganism, preferably a pathogenic microorganism, preferably selected from bacteria, fungi, yeasts and viruses, more preferably bacteria.

A method of making a sanitary article or sanitary article system of the invention, comprising the steps of:

(ii) coating at least the end of the tampon facing the vaginal opening, and / or

(iii) Connecting the vaginal opening end to a waterproof cover.