ITMI20120757A1 - POST COITAL VAGINAL WASHING SYSTEM - Google Patents
POST COITAL VAGINAL WASHING SYSTEM Download PDFInfo
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- ITMI20120757A1 ITMI20120757A1 IT000757A ITMI20120757A ITMI20120757A1 IT MI20120757 A1 ITMI20120757 A1 IT MI20120757A1 IT 000757 A IT000757 A IT 000757A IT MI20120757 A ITMI20120757 A IT MI20120757A IT MI20120757 A1 ITMI20120757 A1 IT MI20120757A1
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- 238000005406 washing Methods 0.000 title claims description 20
- 230000001113 coital effect Effects 0.000 title claims description 3
- 239000000243 solution Substances 0.000 claims description 13
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 10
- 239000002253 acid Substances 0.000 claims description 9
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 claims description 6
- 239000004327 boric acid Substances 0.000 claims description 6
- 235000011007 phosphoric acid Nutrition 0.000 claims description 5
- 230000001568 sexual effect Effects 0.000 claims description 5
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims description 4
- 239000001540 sodium lactate Substances 0.000 claims description 4
- 235000011088 sodium lactate Nutrition 0.000 claims description 4
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 3
- CYDQOEWLBCCFJZ-UHFFFAOYSA-N 4-(4-fluorophenyl)oxane-4-carboxylic acid Chemical compound C=1C=C(F)C=CC=1C1(C(=O)O)CCOCC1 CYDQOEWLBCCFJZ-UHFFFAOYSA-N 0.000 claims description 2
- 206010020852 Hypertonia Diseases 0.000 claims description 2
- 235000010338 boric acid Nutrition 0.000 claims description 2
- NGSFWBMYFKHRBD-UHFFFAOYSA-M sodium lactate Chemical compound [Na+].CC(O)C([O-])=O NGSFWBMYFKHRBD-UHFFFAOYSA-M 0.000 claims description 2
- 229940005581 sodium lactate Drugs 0.000 claims description 2
- 150000003839 salts Chemical class 0.000 claims 3
- JVTAAEKCZFNVCJ-REOHCLBHSA-N L-lactic acid Chemical compound C[C@H](O)C(O)=O JVTAAEKCZFNVCJ-REOHCLBHSA-N 0.000 claims 2
- JVTAAEKCZFNVCJ-UWTATZPHSA-N D-lactic acid Chemical compound C[C@@H](O)C(O)=O JVTAAEKCZFNVCJ-UWTATZPHSA-N 0.000 claims 1
- 239000008366 buffered solution Substances 0.000 claims 1
- 229960000448 lactic acid Drugs 0.000 claims 1
- NJTGANWAUPEOAX-UHFFFAOYSA-N molport-023-220-454 Chemical compound OCC(O)CO.OCC(O)CO NJTGANWAUPEOAX-UHFFFAOYSA-N 0.000 claims 1
- 208000019802 Sexually transmitted disease Diseases 0.000 description 7
- 241000700605 Viruses Species 0.000 description 5
- 210000004877 mucosa Anatomy 0.000 description 5
- 210000000582 semen Anatomy 0.000 description 5
- 210000001215 vagina Anatomy 0.000 description 4
- 241000725303 Human immunodeficiency virus Species 0.000 description 3
- 241000186660 Lactobacillus Species 0.000 description 3
- 208000009608 Papillomavirus Infections Diseases 0.000 description 3
- 201000010099 disease Diseases 0.000 description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
- 208000015181 infectious disease Diseases 0.000 description 3
- 230000002265 prevention Effects 0.000 description 3
- 230000004083 survival effect Effects 0.000 description 3
- 241000894006 Bacteria Species 0.000 description 2
- 241000606153 Chlamydia trachomatis Species 0.000 description 2
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 2
- 208000022361 Human papillomavirus infectious disease Diseases 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 230000002378 acidificating effect Effects 0.000 description 2
- 230000009471 action Effects 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 210000004027 cell Anatomy 0.000 description 2
- 239000003610 charcoal Substances 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
- 230000021962 pH elevation Effects 0.000 description 2
- 244000052769 pathogen Species 0.000 description 2
- 230000002688 persistence Effects 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 208000030507 AIDS Diseases 0.000 description 1
- 241000193830 Bacillus <bacterium> Species 0.000 description 1
- 208000004926 Bacterial Vaginosis Diseases 0.000 description 1
- 208000035143 Bacterial infection Diseases 0.000 description 1
- 241000222122 Candida albicans Species 0.000 description 1
- 206010007134 Candida infections Diseases 0.000 description 1
- 206010008263 Cervical dysplasia Diseases 0.000 description 1
- 208000035473 Communicable disease Diseases 0.000 description 1
- 241000588724 Escherichia coli Species 0.000 description 1
- 241000713772 Human immunodeficiency virus 1 Species 0.000 description 1
- 244000178870 Lavandula angustifolia Species 0.000 description 1
- 235000010663 Lavandula angustifolia Nutrition 0.000 description 1
- 241000204031 Mycoplasma Species 0.000 description 1
- 241001631646 Papillomaviridae Species 0.000 description 1
- 241000224526 Trichomonas Species 0.000 description 1
- 208000005448 Trichomonas Infections Diseases 0.000 description 1
- 241000224527 Trichomonas vaginalis Species 0.000 description 1
- 206010044620 Trichomoniasis Diseases 0.000 description 1
- 208000037009 Vaginitis bacterial Diseases 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 208000022362 bacterial infectious disease Diseases 0.000 description 1
- 244000052616 bacterial pathogen Species 0.000 description 1
- 210000000270 basal cell Anatomy 0.000 description 1
- 239000007975 buffered saline Substances 0.000 description 1
- 201000003984 candidiasis Diseases 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 230000003750 conditioning effect Effects 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 230000002596 correlated effect Effects 0.000 description 1
- 239000006071 cream Substances 0.000 description 1
- 238000011461 current therapy Methods 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 229940059082 douche Drugs 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000012202 endocytosis Effects 0.000 description 1
- 210000000981 epithelium Anatomy 0.000 description 1
- 210000004392 genitalia Anatomy 0.000 description 1
- 235000011187 glycerol Nutrition 0.000 description 1
- 239000012456 homogeneous solution Substances 0.000 description 1
- 208000021145 human papilloma virus infection Diseases 0.000 description 1
- 239000000819 hypertonic solution Substances 0.000 description 1
- 230000001506 immunosuppresive effect Effects 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 238000011534 incubation Methods 0.000 description 1
- 239000012678 infectious agent Substances 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 230000002427 irreversible effect Effects 0.000 description 1
- 230000002147 killing effect Effects 0.000 description 1
- 239000004310 lactic acid Substances 0.000 description 1
- 235000014655 lactic acid Nutrition 0.000 description 1
- 229940039696 lactobacillus Drugs 0.000 description 1
- 239000001102 lavandula vera Substances 0.000 description 1
- 235000018219 lavender Nutrition 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 230000010534 mechanism of action Effects 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- VNWKTOKETHGBQD-UHFFFAOYSA-N methane Chemical compound C VNWKTOKETHGBQD-UHFFFAOYSA-N 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 238000006386 neutralization reaction Methods 0.000 description 1
- 239000011368 organic material Substances 0.000 description 1
- 230000020477 pH reduction Effects 0.000 description 1
- 244000045947 parasite Species 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 230000001717 pathogenic effect Effects 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 230000002085 persistent effect Effects 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 230000000750 progressive effect Effects 0.000 description 1
- 239000003380 propellant Substances 0.000 description 1
- 230000000069 prophylactic effect Effects 0.000 description 1
- 230000002829 reductive effect Effects 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 239000000344 soap Substances 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 239000000606 toothpaste Substances 0.000 description 1
- 239000003053 toxin Substances 0.000 description 1
- 231100000765 toxin Toxicity 0.000 description 1
- 208000019206 urinary tract infection Diseases 0.000 description 1
- 235000012712 vegetable carbon Nutrition 0.000 description 1
- 239000004108 vegetable carbon Substances 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M3/00—Medical syringes, e.g. enemata; Irrigators
- A61M3/02—Enemata; Irrigators
- A61M3/0204—Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity
- A61M3/0208—Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity before use
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M3/00—Medical syringes, e.g. enemata; Irrigators
- A61M3/02—Enemata; Irrigators
- A61M3/0233—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/14—Female reproductive, genital organs
- A61M2210/1475—Vagina
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Hematology (AREA)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Anesthesiology (AREA)
- Engineering & Computer Science (AREA)
- Urology & Nephrology (AREA)
- Reproductive Health (AREA)
- Gynecology & Obstetrics (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- External Artificial Organs (AREA)
- Devices For Medical Bathing And Washing (AREA)
- Detergent Compositions (AREA)
Description
Descrizione Description
Sistema di lavaggio vaginale post coitale Post coital vaginal washing system
È indiscutibile la validità della protezione (guanti) e dell'igiene (lavaggio) delle mani che sono venute a contatto con materiale organico. Il campo di applicazione del presidio à ̈ l'attività sessuale che pone a contatto gli organi genitali spesso senza protezione (profilattico) e senza l'attuazione della prima norma igienica: il lavaggio. The validity of the protection (gloves) and hygiene (washing) of hands that have come into contact with organic material is indisputable. The field of application of the device is sexual activity that places the genital organs in contact often without protection (prophylactic) and without the implementation of the first hygiene rule: washing.
L’invenzione si riferisce a un sistema di lavaggio vaginale post coitale da eseguire come pratica igienica finalizzata alla prevenzione delle malattie sessualmente trasmesse. The invention refers to a post-coital vaginal washing system to be performed as a hygienic practice aimed at the prevention of sexually transmitted diseases.
Attualmente molte sono le lavande in commercio ma nessuna à ̈ proposta e pertanto idonea, all'igiene vaginale successiva all'attività sessuale. In particolare sia i sistema eroganti: flaconi di plastica con svuotamento manuale e anti gravitazionale sia le formule delle soluzioni lavanti non sono finalizzate e quindi adeguate all'igiene post coitale e quindi alla prevenzione delle malattie sessualmente trasmesse. Currently there are many douches on the market but none are proposed and therefore suitable for vaginal hygiene following sexual activity. In particular, both the dispensing systems: plastic bottles with manual and anti-gravity emptying and the formulas of the washing solutions are not aimed and therefore adequate for post-coital hygiene and therefore for the prevention of sexually transmitted diseases.
Non esistono dispositivi o strumenti, conosciuti o comunque in uso, aventi come indicazione l'igiene post coitale. L'assenza di un dispositivo specifico e l'aumento dei rapporti promiscui, spesso in condizioni igieniche non favorevoli, sono la probabile causa dell'attuale aumento delle malattie sessualmente trasmesse. There are no devices or tools, known or in any case in use, with post-coital hygiene as an indication. The absence of a specific device and the increase in promiscuous relationships, often in unfavorable hygienic conditions, are the probable cause of the current increase in sexually transmitted diseases.
L'invenzione à ̈ in grado di colmare tale necessità consentendo di prendere provvedimenti igienici post coitali. L'innovativo e originale erogatore e la formula lavante, specificamente studiate, per la prima volta costituiscono un dispositivo per l'igiene vaginale post coitale il cui uso avrà la possibilità di ridurre le malattie sessualmente trasmesse con i conseguenti benefici sociali. The invention is able to fill this need by allowing post-coital hygiene measures to be taken. The innovative and original dispenser and washing formula, specifically designed, for the first time constitute a device for post-coital vaginal hygiene whose use will have the possibility of reducing sexually transmitted diseases with the consequent social benefits.
La presente invenzione ha per oggetto un sistema costituito da: The present invention relates to a system consisting of:
1. una soluzione lavante tamponata ipertonica a pH acido, 1. a hypertonic buffered washing solution at acid pH,
2. un contenitore pressurizzato, di metallo (rigido), a pressione predefinita, dalla quale fuoriesce un’onda di soluzione lavante in grado di svuotare e condizionare la mucosa vaginale ed in particolare il suo pH. 2. a pressurized container, made of metal (rigid), at predefined pressure, from which a wave of washing solution comes out, capable of emptying and conditioning the vaginal mucosa and in particular its pH.
Si tratta di un sistema ben definito: “bag on valve technology “, impiegato a due compartimenti e ampliamente utilizzato per dispensare saponi, dentifrici e creme, ma per la prima volta à ̈ utilizzato per costruire una lavanda vaginale. Tale dispositivo ci consente di utilizzare la soluzione lavante senza conservanti, pur garantendo l’assenza di contaminazioni. In questo sistema infatti, la soluzione lavante e il propellente (gas) restano separati anche durante l'uso. It is a well-defined system: â € œbag on valve technology â € œ, employed in two compartments and widely used to dispense soaps, toothpastes and creams, but for the first time it is used to build a vaginal douche. This device allows us to use the washing solution without preservatives, while ensuring the absence of contamination. In fact, in this system, the washing solution and the propellant (gas) remain separate even during use.
Con una sola e semplice pressione sulla valvola di tipo up/down si produce lo svuotamento totale della bombola. La carica di aria compressa (N2) a 8 bars consente la formazione di un'onda lavante costante e progressiva. Lo svuotamento avviene in qualsiasi posizione della bombola, che può pertanto essere utilizzata rovesciata come à ̈ necessario per il lavaggio della cavità vaginale, senza obbligare la donna ad assumere particolari posizioni. With a single and simple pressure on the up / down valve the total emptying of the cylinder is produced. The charge of compressed air (N2) at 8 bars allows the formation of a constant and progressive washing wave. The emptying takes place in any position of the tank, which can therefore be used upside down as is necessary for washing the vaginal cavity, without forcing the woman to take particular positions.
Sfondo dell’invenzione Background of the invention
La cavità vaginale dopo un rapporto sessuale viene a contatto con il liquido seminale e può divenire la sede di deposito di numerose sostanze estranee quali microrganismi protozoi e soprattutto virus che determinano le malattie sessualmente trasmesse. Tali infezioni spesso si correlano all'alcalinizzazione della cavità vaginale indotta dal liquido seminale. The vaginal cavity after sexual intercourse comes into contact with the seminal fluid and can become the deposit site of numerous foreign substances such as protozoan microorganisms and above all viruses that cause sexually transmitted diseases. Such infections often relate to seminal fluid-induced alkalinization of the vaginal cavity.
1. La vaginosi batterica à ̈ l'infezione più diffusa tra le donne, la malattia si associa e/o induce nel 5% dei casi la candidosi. La condizione etiopatogenetica favorente à ̈ l'aumento del pH vaginale dovuto all'alterazione dell'ecosistema vaginale. Il pH vaginale fisiologico à ̈ circa 4,0 - 4,5)<1>. I batteri patogeni inducono una diminuzione dei Lactobacilli (o Bacillo di Doderlein), deputati a mantenere acido l'ambiente vaginale. La leucorrea à ̈ di cattivo odore, ha un pH maggiore di 4,5 e si correla alla diminuzione dei lactobacilli. 1. Bacterial vaginosis is the most widespread infection among women, the disease is associated with and / or induces candidiasis in 5% of cases. The favoring etiopathogenetic condition is the increase in vaginal pH due to the alteration of the vaginal ecosystem. The physiological vaginal pH is about 4.0 - 4.5) <1>. Pathogenic bacteria induce a decrease in Lactobacilli (or Bacillus of Doderlein), responsible for keeping the vaginal environment acidic. Leucorrhea has a bad smell, has a pH greater than 4.5 and is correlated to the decrease in lactobacilli.
L’immissione del liquido spermatico in vagina notoriamente aumenta il pH di 2-3 unità superiore a quello dell’ambiente vaginale fisiologico. La terapia attuale oltre agli antibiotici che inducono resistenza si basa a sostegno dell’importanza del pH nell’introduzione in vagina d’acido borico sotto varie forme (ovuli, lavande), il suo meccanismo d'azione può essere attribuito alle sue proprietà di acido debole. The introduction of spermatic fluid into the vagina notoriously increases the pH of 2-3 units higher than that of the physiological vaginal environment. The current therapy in addition to antibiotics that induce resistance is based in support of the importance of pH in the introduction into the vagina of boric acid in various forms (ovules, douches), its mechanism of action can be attributed to its weak acid properties.
2. Anche la trichomoniasi vaginale à ̈ una malattia venerea (le prostitute sono infette nella misura variabile dal 47 al 73% di campioni scelti a caso). Anche in questo caso, come nelle infezioni batteriche, tempo di permanenza e alcalinizzazione sono i due parametri importanti per l'instaurarsi della malattia. Il protozoo altera il pH vaginale inibendo la formazione di acido lattico dal lattobacillo di Doderlein e provoca uno spostamento dei valori del pH fino a 6 che sono ottimali per lo sviluppo del parassita stesso. IL T. vaginalis tappezza quindi la mucosa vaginale sulla quale si impianta e sopravvive e da dove può spostarsi per manifestare la sua azione patogena che, oltre all'azione meccanica, potrebbe anche essere realizzata attraverso l'azione di una tossina che à ̈ stata dimostrata in colture di tessuto. Il periodo di incubazione varia da pochi giorni (3-4) ad alcune settimane. Il pH vaginale acido à ̈ stato associato ad un ridotto rischio di C. trachomatis, trichomonas, micoplasmi<2>e infezioni del tratto urinario<3>. 2. Vaginal trichomoniasis is also a venereal disease (prostitutes are infected to the extent of 47 to 73% of randomly selected samples). Also in this case, as in bacterial infections, residence time and alkalinization are the two important parameters for the onset of the disease. The protozoan alters the vaginal pH by inhibiting the formation of lactic acid from Doderlein's lactobacillus and causes a shift in pH values up to 6 which are optimal for the development of the parasite itself. T. vaginalis therefore covers the vaginal mucosa on which it implants and survives and from where it can move to manifest its pathogenic action which, in addition to the mechanical action, could also be achieved through the action of a toxin that has been demonstrated in tissue cultures. The incubation period varies from a few days (3-4) to a few weeks. Acid vaginal pH has been associated with a reduced risk of C. trachomatis, trichomonas, mycoplasma <2> and urinary tract infections <3>.
3. Anche i virus, hanno una buona stabilità a pH neutro, in particolare quello dell’AIDS, che à ̈ rapidamente inattivato a pH più acidi. Ongrádi J. et al. così concludono il loro lavoro: “It was established that, the cell-free HIV-1 particles are very sensitive to acidity. Between pH 7.4 and 6.0 they loose infectivity gradually, but this process is irreversible under pH 6.0 and subsequent neutralization cannot restore lost infectivity†.<4>3. Viruses also have good stability at neutral pH, in particular that of AIDS, which is rapidly inactivated at more acidic pH. Ongrádi J. et al. thus they conclude their work: â € œIt was established that, the cell-free HIV-1 particles are very sensitive to acidity. Between pH 7.4 and 6.0 they loose infectivity gradually, but this process is irreversible under pH 6.0 and subsequent neutralization cannot restore lost infectivityâ €. <4>
È stato riferito che l'aumento del pH vaginale (≥ 5.0) à ̈ legato alla individuazione del papilloma virus (HPV) cancerogeno e in particolare alle infezioni di tipo multiplo e LSIL, in certe fasce di età e con la rilevazione del DNA di C. trachomatis in donne di età <25 anni<5>. It has been reported that the increase in vaginal pH (â ‰ ¥ 5.0) is linked to the detection of the cancerous papilloma virus (HPV) and in particular to multiple-type infections and LSIL, in certain age groups and with the detection of DNA of C. trachomatis in women aged <25 years <5>.
È noto che l'endocitosi dell'HPV da parte delle cellule basali dell'epitelio pavimentoso stratificato non corneificato della mucosa vaginale avviene molto lentamente e asincrono<5 6>. HPV endocytosis by the basal cells of the non-corneified stratified pavement epithelium of the vaginal mucosa is known to occur very slowly and asynchronously <5 6>.
In sintesi i recenti lavori come quello in pubblicazione di Campos et al. dimostrano che l'aumento del pH vaginale à ̈ di fondamentale importanza sia per per la sopravvivenza dell'HIV sia per essere associato con l'infezione da HPV<7>. Inoltre l’attività sessuale può essere la causa di microlacerazioni della mucosa vaginale che favorirebbero a probabilità di attecchimento degli agenti infettivi e/o il loro passaggio in circolo. In summary, recent works such as the one in publication by Campos et al. demonstrate that increasing vaginal pH is of paramount importance both for HIV survival and for being associated with HPV infection <7>. Furthermore, sexual activity can be the cause of microlacerations of the vaginal mucosa which would favor the probability of engraftment of infectious agents and / or their passage into the circulation.
Assume quindi decisiva importanza per la prevenzione igienica la persistenza del liquido seminale in vagina e quindi il tempo durante il quale il pH vaginale rimane alterato dopo la sua immissione. Il persistere quindi di un valore di pH alterato rispetto a quello fisiologico à ̈ infatti, il principale aiuto alla sopravvivenza dei virus e/o dei batteri e/o dei protozoi eventualmente introdotti nella cavità vaginale e causa delle malattie sessualmente trasmesse. The persistence of the seminal fluid in the vagina and therefore the time during which the vaginal pH remains altered after its introduction assumes decisive importance for hygienic prevention. The persistence of an altered pH value compared to the physiological one is in fact the main aid to the survival of the viruses and / or bacteria and / or protozoa that may be introduced into the vaginal cavity and cause sexually transmitted diseases.
Per ridurre il tempo di permanenza del liquido seminale e degli agenti patogeni nella cavità vaginale e quindi la penetrazione di tali sostanze all’interno della mucosa e nelle sue cellule costituenti à ̈ necessario creare un’onda di lavaggio che abbia la forza e la capacità di svuotare la cavità vaginale. Si evita così che il liquido seminale permanga a lungo all'interno della vagina manifestando il suo effetto immunosoppressivo e la sua capacità di alterare il pH, favorendo come riportato in letteratura l'infezione da HPV. Inoltre la contemporane immediata e persistente acidificazione, indotta dall'igiene vaginale post coitale attuata mediante il dispositivo oggetto dell'invenzione, può significare l’uccisione dei patogeni e in particolare del virus HIV. To reduce the residence time of seminal fluid and pathogens in the vaginal cavity and therefore the penetration of these substances into the mucosa and its constituent cells, it is necessary to create a washing wave that has the strength and ability to empty the vaginal cavity. This prevents the seminal fluid from remaining inside the vagina for a long time, manifesting its immunosuppressive effect and its ability to alter the pH, favoring HPV infection as reported in the literature. Furthermore, the simultaneous immediate and persistent acidification, induced by post-coital vaginal hygiene carried out by means of the device object of the invention, can mean the killing of pathogens and in particular of the HIV virus.
Si à ̈ ora trovata una nuova originale e mai usata prima lavanda vaginale, proposta come presidio per l'igiene post coitale. A new original and never used before vaginal lavage has now been found, proposed as a device for post-coital hygiene.
Il sistema schematizzato nella figura 1 à ̈ costituito da un flacone pressurizzato a 6 ± 2 atm, contenente un contenitore che à ̈ riempito con la soluzione salina tamponata, ipertonica e a pH acido (studiata come adeguata per l’igiene del dopo). Il sistema à ̈ collegato e completato dalla classica cannula vaginale e può alla semplice pressione del tappo, determinare l’uscita di un’onda di volume e forza in grado di svuotare la cavità vaginale. The system schematized in figure 1 consists of a pressurized bottle at 6 ± 2 atm, containing a container that is filled with the buffered saline solution, hypertonic and acid pH (studied as suitable for hygiene afterwards). The system is connected and completed by the classic vaginal cannula and can, at the simple pressure of the cap, determine the release of a wave of volume and force capable of emptying the vaginal cavity.
L’innovativa composizione (dettagliata nell'esempio n° 1) della soluzione à ̈ a base di acido fosforico, DL-lattato di sodio ed acido borico ed à ̈ caratterizzata dall’avere un pH acido (4 ± 0,2) e una forte ipertonicità . The innovative composition (detailed in example n ° 1) of the solution is based on phosphoric acid, sodium DL-lactate and boric acid and is characterized by having an acid pH (4 ± 0.2) and a strong hypertonicity.
Esempio 1 Example 1
Si à ̈ preparata una soluzione costituita da 50 mL di sodio lattato al 50%, (densità 1,27), 6 mL di acido ortofosforico all’85% (densità 1,689), 30 g di acido borico e 50 g di glicerina (densità 1,262), portando il tutto in soluzione omogenea ad 1 L con acqua bidistillata. Il pH risultante era di 4 ± 0,25. Tale soluzione à ̈ stata inserita nel sistema pressurizzato secondo le GMP. A solution was prepared consisting of 50 mL of 50% sodium lactate (density 1.27), 6 mL of 85% orthophosphoric acid (density 1.689), 30 g of boric acid and 50 g of glycerin ( density 1,262), bringing the whole in a homogeneous solution to 1 L with bidistilled water. The resulting pH was 4 ± 0.25. This solution has been included in the pressurized system according to the GMP.
Si à ̈ valutata la capacità della lavanda di condizionare il pH e soprattutto stabilire il tempo di ripristino del pH basale e l'eventuale effetto "rebound". The ability of lavender to condition the pH was evaluated and above all to establish the time of restoration of the basal pH and the possible "rebound" effect.
Si à ̈ selezionata la condizione di partenza più svantaggiosa pH basale di 5 ± 0,4. I risultati riportati in figura 2 mostrano la capacità del sistema di acidificare la cavità vaginale dopo lavaggio ed il ritorno al pH basale dopo un ora (1 min. pH 3,6 ± 0,27; 20 min. pH 4,1 ± 0,32; 1 ora pH 5,6 ± 0,61). The most disadvantageous starting condition was selected. Basal pH of 5 ± 0.4. The results shown in figure 2 show the ability of the system to acidify the vaginal cavity after washing and the return to basal pH after one hour (1 min. PH 3.6 ± 0.27; 20 min. PH 4.1 ± 0, 32; 1 hour pH 5.6 ± 0.61).
Conclusione: Il dispositivo oggetto dell'invenzione si à ̈ dimostrato in grado di acidificare la cavità vaginale e mantenerla tale per 1 ora. Tali condizioni sono quelle che in letteratura significano diminuita sopravvivenza dei virus, batteri e protozoi responsabili delle malattie sessualmente trasmesse. Conclusion: The device object of the invention has been shown to be able to acidify the vaginal cavity and keep it that way for 1 hour. These conditions are those that in the literature mean decreased survival of the viruses, bacteria and protozoa responsible for sexually transmitted diseases.
Esempio 2 Example 2
Si à ̈ posto in 3 ml di soluzione fisiologica 0,2 g di carbone vegetale. Tale sospensione à ̈ stata depositata nella cavità vaginale e dopo 10 minuti à ̈ stato recuperato con il lavaggio vaginale il carbone vegetale. It is placed in 3 ml of saline 0.2 g of charcoal. This suspension was deposited in the vaginal cavity and after 10 minutes the charcoal was recovered with the vaginal washing.
Risultato: ± il 98 % teorico del carbone vegetale à ̈ stato recuperato nel liquido di lavaggio. Ovviamente à ̈ stato corretto il valore ottenuto (peso nel volume recuperato) al volume nominale. Result: ± the theoretical 98% of the vegetable carbon was recovered in the washing liquid. Obviously, the value obtained (weight in the recovered volume) has been corrected to the nominal volume.
Conclusione: come prevedibile utilizzando un volume di lavaggio > di 10 volte il volume seminale si dimostra il completo lavaggio della cavità vaginale. Conclusion: as expected, using a wash volume> 10 times the seminal volume, complete washing of the vaginal cavity is demonstrated.
Bibliografia Bibliography
<1>Donders GG. Definition and classification of abnormal vaginal flora. Best Pract Res Clin Obstet Gynaecol 2007, 21:355-373. <1> Donders GG. Definition and classification of abnormal vaginal flora. Best Pract Res Clin Obstet Gynaecol 2007, 21: 355-373.
2 Hanna NF, Taylor-Robinson D, Kalodiki-Karamanoli M, Harris JR, McFadyen IR: The relation between vaginal pH and the microbiological status in vaginitis. Br J Obstet Gynaecol 1985, 92:1267-1271. 2 Hanna NF, Taylor-Robinson D, Kalodiki-Karamanoli M, Harris JR, McFadyen IR: The relation between vaginal pH and the microbiological status in vaginitis. Br J Obstet Gynaecol 1985, 92: 1267-1271.
3 Stamey TA, Kaufman MF: Studies of introital colonization in women with recurrent urinary infections. II. A comparison of growth in normal vaginal fluid of common versus uncommon serogroups of Escherichia coli. J Urol 1975, 114:264-267. 3 Stamey TA, Kaufman MF: Studies of introital colonization in women with recurrent urinary infections. II. A comparison of growth in normal vaginal fluid of common versus uncommon serogroups of Escherichia coli. J Urol 1975, 114: 264-267.
4 Ongrádi J, Ceccherini-Nelli L, Pistello M et al. Different sensitivity to acid reaction of the AIDS virus and virus-producing cells: clinical conclusions. Orv Hetil. 1990 Sep 9;131(36):1959-64. 4 Ongrádi J, Ceccherini-Nelli L, Pistello M et al. Different sensitivity to acid reaction of the AIDS virus and virus-producing cells: clinical conclusions. Orv Hetil. 1990 Sep 9; 131 (36): 1959-64.
5 Clarke MA, RodriguezAC, Gage JC et al.: A large, population-based study of agerelated associations between vaginal pH and human papillomavirus infection. BMC Infectious Diseases 2012;12:33. 5 Clarke MA, RodriguezAC, Gage JC et al .: A large, population-based study of agerelated associations between vaginal pH and human papillomavirus infection. BMC Infectious Diseases 2012; 12:33.
6 Culp TD, Christensen ND (2004) Kinetics of in vitro adsorption and entry of �papillomavirus virions. Virology 319: 152–161. 6 Culp TD, Christensen ND (2004) Kinetics of in vitro adsorption and entry of �papillomavirus virions. Virology 319: 152â € “161.
7 Campos AC, Murta EF, Michelin MA et al. Evaluation of Cytokines in Endocervical Secretion and Vaginal pH from Women with Bacterial Vaginosis or Human Papillomavirus. Obstet Gynecol. 7 Campos AC, Murta EF, Michelin MA et al. Evaluation of Cytokines in Endocervical Secretion and Vaginal pH from Women with Bacterial Vaginosis or Human Papillomavirus. Obstet Gynecol.
2012;3:42-75. 2012; 3: 42-75.
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| US3219525A (en) * | 1963-01-16 | 1965-11-23 | Menlo Park Lab Inc | Vaginal douche solution |
| US3346451A (en) * | 1965-01-27 | 1967-10-10 | S E Massengill Company | Concentrated liquid lactic acid douche preparation containing aromatics |
| US4592748A (en) * | 1984-05-18 | 1986-06-03 | Vortex Research Corp. | Yoghurt based douche kit and assembly therefor |
| EP0496230A1 (en) * | 1991-01-23 | 1992-07-29 | ASTA Medica Aktiengesellschaft | Preparation of an extract of camomile with antimicrobial properties |
| US20030099720A1 (en) * | 2001-11-27 | 2003-05-29 | Kelly Patrick D. | Pre-coital and post-coital rinse with anti-viral and skin-protective zinc salts |
| US6589216B1 (en) * | 2002-02-20 | 2003-07-08 | Abbott Research Group, Inc. | Vaginal douches, vaginal douche applicators and methods of vaginal douching |
| WO2006089561A1 (en) * | 2005-02-23 | 2006-08-31 | Abbas Abdelsalam Ghazi | Pharmaceutical compositions containing organic acids useful for softening and ripening uterine cervix. |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3219525A (en) * | 1963-01-16 | 1965-11-23 | Menlo Park Lab Inc | Vaginal douche solution |
| US3346451A (en) * | 1965-01-27 | 1967-10-10 | S E Massengill Company | Concentrated liquid lactic acid douche preparation containing aromatics |
| US4592748A (en) * | 1984-05-18 | 1986-06-03 | Vortex Research Corp. | Yoghurt based douche kit and assembly therefor |
| EP0496230A1 (en) * | 1991-01-23 | 1992-07-29 | ASTA Medica Aktiengesellschaft | Preparation of an extract of camomile with antimicrobial properties |
| US20030099720A1 (en) * | 2001-11-27 | 2003-05-29 | Kelly Patrick D. | Pre-coital and post-coital rinse with anti-viral and skin-protective zinc salts |
| US6589216B1 (en) * | 2002-02-20 | 2003-07-08 | Abbott Research Group, Inc. | Vaginal douches, vaginal douche applicators and methods of vaginal douching |
| WO2006089561A1 (en) * | 2005-02-23 | 2006-08-31 | Abbas Abdelsalam Ghazi | Pharmaceutical compositions containing organic acids useful for softening and ripening uterine cervix. |
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