MXPA99008408A - Tampon and method of making same - Google Patents

Abstract

Absorptive pads including catamenial tampons are provided which are characterized by O2 levels sufficiently reduced so as to reduce the introduction of air into the vaginal canal with a resulting reduction in the probability of production of toxic shock syndrome exotoxin during internal use of the pads.

Description

TAMPON AND METHOD TO DEVELOP THE SAME BACKGROUND OF THE INVENTION The invention relates generally to absorption pads for internal use, including surgical and wound bandages and packages, and surgical sponges and more specifically to catamenial tampons. The invention is further related to absorption pads intended to reduce the introduction of air into the vagina channel with a resultant reduction in the likelihood of exotoxin production from toxic shock syndrome as a result of the insertion of these pads and the methods for the production of these pads. Toxic shock syndrome is a syndrome with a higher mortality coefficient characterized by rapid onset of high fever, vomiting, diarrhea and rash followed by a rapid fall in blood pressure and failure of the vital organ. The toxic shock syndrome is associated with the presence of the bacterium Staphylococcus aureus and an even more exotoxin that are produced by the bacteria. Exotoxins associated with toxic shock syndrome include Exotoxin A, B and C, Pyrrogenic Exotoxin, Enterotoxin A, Enterotoxin B, Enterotoxin C, Staphylococcal Enterotoxin F and Toxin Shock Syndrome Toxin-1 . The toxic shock syndrome is not caused by bacteria per se, but instead by the toxic effects of the associated exotoxin which passes from the vagina and other internal cavities of the body into the bloodstream. The toxic shock syndrome is found to be associated with the use of absorption pads within the vagina, which can promote the growth of bacteria and the production of exotoxin in their vicinity. The field of invention was observed, the syndrome with the surgical bandages seems to be particularly associated with the use of catamenial tampons. The syndrome seems to occur with high frequency in association with those absorption pads that are characterized by high levels of absorbency and which, therefore, are left inside the body for prolonged periods. Of interest to the present invention is the observation of Robbins et al., J. Clin. Microbiol., 25, 1446-1449 (1987) that the main role of buffers in toxic shock syndrome may be that of providing a fibrous surface for dense colonization and sufficient air for the production of the toxin. Lee et al., J. Clin. Microbiol., 25, 87-90 (1987) sus and that in which high CO2 levels promote the production of the toxin. Although a preferred approach for reducing the risk of toxic shock syndrome when using absorption pads is to frequently change new pads for those used, several other approaches have been proposed in the art to reduce the risk of toxic shock syndrome associated with an internal absorbent pad. One approach is to incorporate antibiotics or other bactericides into the absorbent pads as described by Leveen et al., U.S. Patent No. 5,000,749 and U.S. Patent No. 5,070,889, which disclose in the use of bactericides of iodine in catamenial tampons and sponges. This approach is not always suitable for use in a catamenial product, however, because a bactericide that is active against Staphylococcus aureus can adversely affect other bacteria that form the vaginal flora. In a related method, Lefren et al., U.S. Patent No. 4,431,427 describes the use of catamenial buffers comprising substances such as organic acids that will maintain a pH of about 4.5 to 2.5 on the fluids absorbed during the use of the buffers. , in such a way that the growth of the pathogenic bacteria is inhibited.

Other approaches that are aimed at the inactivation of the toxic shock syndrome exotoxin. Jacob et al., In U.S. Pat. No. 4,585,792; U.S. Patent No. 4,722,936; and U.S. Patent No. 4,722,937 describes the administration of L-ascorbic acid for the detoxification of Staphylococcus aureus toxins, rooting exotoxin C and enterotoxin F. Although Jacob et al. does not describe a mechanism for the effectiveness of ascorbic acid In neutralizing the toxic shock syndrome exotoxin, they observed that L-ascorbic acid is known to be a reducing agent and a strong antioxidant and that it could operate to inactivate bacterial toxins by reducing the disulfide bonds within the toxins . Another approach is aimed at incorporating substances into an absorbent pad, which inhibits the production of toxic shock syndrome exotoxin by Staphylococcus aureus. Kass, U.S. Patent No. 4,769,021 discloses the incorporation of non-toxic divalent magnesium cations into absorption pads in order to reduce the concentrations of available magnesium ions below those critical for optimal production of toxin-1. of toxic shock syndrome and other staphylococcus products. Of interest for the present invention are conventional tampons and inserts of various designs, including those described by U.S. Patent No. 3,902,493 to Baier et al .; U.S. Patent No. 4,077,409 to Murray et al .; U.S. Patent No. 4,286,596 to Rubinstein; U.S. Patent No. 4,413,986 to Jacobs; U.S. Patent No. 4,431, 427 to Lefren et al .; U.S. Patent No. 4,447,222 to Sartinoranont; and U.S. Patent No. 4,486,191 to Jacob. Despite developments, there remains a desire in the art for absorbent pads suitable for internal use, including catamenial tampons, which are characterized by the reduced risk of toxic shock syndrome.

BRIEF DESCRIPTION OF THE INVENTION The present invention provides improved catamenial buffers, wherein the buffers are intended to inhibit the increased production of the toxic shock syndrome exotoxin during its use. Methods for the production of these buffers are also provided. The present invention relates to the observation that while the toxic shock syndrome exotoxin is produced at low levels under anaerobic conditions that normally exist in the vagina, its production is greatly increased under aerobic conditions (ie, in the presence of molecular oxygen, O2). It has also been observed that the presence of carbon dioxide (C0) that promotes the production of the toxic shock syndrome exotoxin. Because absorbent pads including catamenial tampons contain large amounts of air in their interstices including 02 and C02, the use of those pads in normally anaerobic environments such as the vagina can promote the production of the toxic shock syndrome exotoxin. The present invention provides a combination of catamenial buffer and inserter characterized by having a sufficiently reduced O2 level to reduce the introduction of O2 into the vagina channel with a resulting reduction in the probability of toxic exotoxin production of exotoxin. during internal use of the tampon. According to the preferred embodiments, the amount of oxygen present in the catamenial buffer should be less than 2 x 10 ~ 4 moles and preferably less than 1 x 10"5 moles.According to the preferred embodiments, the partial pressure of the oxygen in the vagina about 90 minutes after insertion of the tampon is less than about 50 mm Hg. According to one embodiment of the invention, oxygen (and C02) normally present the pad is replaced with a biocompatible gas that does not promote the production of Exotoxin from toxic shock syndrome These gases include, but are not limited to, nitrogen (N2), neon, argon, helium, fluorinated hydrocarbons, and other suitable biocompatible gases that have a vapor pressure greater than one atmosphere at zero degrees Celsius According to another embodiment, the absorbent pad is physically sealed in a manner that prevents the infiltration of oxygen and carbon dioxide into a pad. substantially, the buffer is sealed under a positive hydrostatic pressure with a biocompatible gas that does not promote the production of the toxic shock syndrome exotoxin so that oxygen and carbon dioxide will not be introduced into the vagina during the insertion of the buffer. According to another embodiment, the pad and / or the inserter can also comprise oxygen scavengers and / or carbon dioxide. According to yet another embodiment, the level of carbon dioxide in the catamenial buffer is sufficiently reduced to be effective in reducing the production of the toxic shock syndrome exotoxin. The amount of C02 present in the catamenial buffer should be less than 3.1 x 10"7 moles and preferably less than 1.6 x 10'8 moles The invention further provides methods for producing the combination of buffer and inserter comprising a catamenial buffer characterized by have an oxygen level sufficiently reduced to be effective in reducing the production of the toxic shock syndrome exotoxin during internal use of the buffer, and an inserter in closing the buffer and reducing the contamination of the buffer with the oxygen of the environment during storage comprising the steps of (1) producing a catamenial buffer, (2) removing the oxygen present in the buffer, and (3) sealing the buffer with the inserter enclosing the buffer.An alternate method comprises the steps of ( 1) produce a catamenial buffer, (2) provide an inserter, (3) place the buffer inside the inserter, (4) remove the oxygen present in the inserter, (5) remove the oxygen present in the buffer, and (6) seal the buffer with the inserter enclosing the buffer. Although the tampon is then sealed in the inserter under a vacuum, it is preferred that the oxygen present in the buffer (and in the inserter) be replaced with a biocompatible gas which does not promote the production of toxic shock syndrome, the preferred gases including nitrogen, neon, argon, helium and a fluorinated hydrocarbon having a vapor pressure greater than one atmosphere at zero degrees centigrade. A further alternative method of producing the tampon and inserter combination comprises the steps of (1) producing a catamenial buffer under substantially oxygen-free conditions, (2) providing an inserter, and (3) sealing the tampon with the enclosing inserter. of buffer. Preferably, the buffer is produced in the presence of a biocompatible gas that does not promote the production of the toxic shock syndrome, most preferably a member selected from the group consisting of nitrogen, neon, argon, helium, and fluorinated hydrocarbons having a vapor pressure greater than one atmosphere at zero degrees centigrade. The step of sealing the tampon with the inserter is closing the buffer is preferably carried out in the presence of the biocompatible gas which can then be closed inside the inserter at a high positive pressure.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a side elevational view, in cross section, of a catamenial tampon and inserter according to the present invention; Figure 2 is a side elevational view, in cross section, of a catamenial tampon and inserter having a bellows device in accordance with the present invention; and Figure 3 is a side elevational view, in cross section, of a catamenial tampon and inserter having a container or chamber containing gas.

DETAILED DESCRIPTION The present invention is directed to improved absorbent pads for internal use including catamenial tampons, wherein the pads are intended to inhibit the increased production of the toxic shock syndrome (SCT) exotoxin during use. Methods for producing these pads are also provided. The absorbent pads of the invention are characterized by having a level of oxygen sufficiently low to be effective in reducing the production of the toxic shock syndrome exotoxin during internal use of the tampon. The physical characteristics of the present invention are referred to in FIG. 1. The combination of tampon and inserter 10 is constructed with three different articles: a tampon 20, an insertion element such as a plunger 30, and a sealed cylinder 50. The inserter comprises the plunger 30 and the cylinder 50. The tampon 20 is disposed within the sealed cylinder 50 and is enclosed by the inserter. The buffer 20 is intended to reduce the introduction of air into the vaginal canal with a resultant reduction in the likelihood of the production of the toxic shock syndrome exotoxin during the internal use of these pads. A bead 80 extends from tampon 20 and is preferably retained in the back portion of plunger 30 to prevent cord 80 from acting as a channel for the surrounding air to enter plunger 30. Insertion of tampon 20 is accomplished by pushing a bladder element. grip 70 can be very posterior of plunger 30 towards a gripping element 60 or the rear end of sealed cylinder 50. The front end or end of sealed cylinder 50 remote to plunger 30 will then break upon insertion to allow tampon 20 to enter to the vagina of the user. According to one embodiment of the invention, the inserter includes the plunger 30 at the rear end of the sealed cylinder 50. As seen in Figure 2, the plunger 30 may include a bellows device 100 attached to or integrally sealed with the sealed cylinder 50. The bellows device 100 maintains a seal as a user presses the plunger 30 inward toward sealed cylinder 50. The bellows device 100 may contain a pressurized biocompatible gas to inhibit oxygen and carbon dioxide from migrating from the bellows device 100. towards sealed cylinder 50. In such a mode that, bellows device 100 reduces the replacement of biocompatible gas with oxygen during storage and insertion. The bellows device 100 preferably has a permeation coefficient for nitrogen of less than about 3 x 10"9 (cm3mm) / sec cm2 cm Hg) and a lower permeation coefficient of about 1.5 x 10 ~ 9 (cm3mm) / sec cm2 cm Hg). (Standard method ASTM D 1434-82 is suitable for measuring permeation coefficients.) Additionally or alternatively to bellows device 100, the inserter may include an O 110 gasket or ring to seal the interface between the plunger 30 and the sealed cylinder 50. As an alternative to the bellows device 100, the O-ring 110 is a less bulky element for sealing the inserter.However, as mentioned above, the bellows device 100 can be filled with a Pressurized biocompatible gas if desired, Preferably, a combination of bellows device 100 and O-ring 110 is used to seal the inserter.

Preferably, the sealed cylinder 50 is between about 5.5 and 8.5 centimeters in length and has an outer diameter of about 1.0 to 1.6 centimeters. The plunger 30 preferably has an outer diameter of approximately 0.6 to 1.4 centimeters and a length of approximately 6.0 to 8.1 centimeters. The total length of the inserter, including the plunger 30 and the sealed cylinder 50, is preferably approximately 10.0 to 14 centimeters before insertion of the tampon. Although described above as cylindrical, the cross-sectional shape of the inserter, including the sealed cylinder 50 and the plunger 30, may be of any convenient shape. It is also appropriate to make the inserter from a cheap plastic material. The right materials to form e! Inserters include polymers that can be injection molded or blow molded. Alternatively, the inserter has formed from a sufficiently rigid laminate that is rolled to form a cylinder, with side seam, with a tip that is attached to one end of the cylinder. As discussed below, materials that have particular permeation coefficients are preferred for inserters of some modalities. The volume of the tampon inserter is between about 5 and 15 millimeters, preferably between about 6 and 12 millimeters. An outwardly projecting member may be attached to the sealed cylinder 50 between the gripping member 60 and the forward end of the sealed cylinder 50. The outwardly projecting member provides a convenient means for positioning the sealed cylinder 50 coupled to the lips and preventing the butt end of the sealed cylinder 50 from being inserted too far into the vagina. During the insertion of the tampon 20 into the vagina, the plunger 30 is sunk towards the sealed cylinder 50 which breaks the end of the sealed cylinder 50 away from the plunger 30 and inserts the tampon 20 into the vagina of the user. The combination of buffer and inserter 10 preferably introduces a biocompatible gas that does not promote the production of the toxin shock syndrome exotoxin in the vagina. The biocompatible gas also inhibits the migration of oxygen and carbon dioxide to the vagina during the removal of the inserter. These gases include, but are not limited to, nitrogen (N2), neon, argon, helium, fluorinated hydrocarbons, and other suitable biocompatible gases that have a vapor pressure greater than one atmosphere at zero degrees centigrade. Preferably, the partial pressure of oxygen in the vagina 90 minutes after the insertion of the buffer is less than about 50 mm Hg. The partial pressure of oxygen produced in the vagina by the insertion of conventional tampons using conventional inserters is disclosed by Wagner et al., Am. J. Obstet. Gynecol., 148, 147-150 (1984). The telescopic tube type inserter may have flexible segments tapered inwardly at the end of the suede or to form a normally closed, smooth, open front end. The tampon 20 is compacted in a resilient manner and is maintained in that condition before and during insertion by placing it inside the tubular inserter. An assembly for sterile insertion within a vagina can be used, which comprises a semi-rigid insertion tube, containing the tampon, telescopically inside a semi-rigid guide tube having a flexible cover secured at its inner end, the which is forced back into the insertion tube. The user aligns the assembly with the vaginal canal and sinks the insertion tube into the guide tube in such a way that part of the insertion tube enters the vagina while the flexible cover extends to line the insertion part of the insertion tube inside the vagina. That subsequently, a plunger is used to expel the tampon from the insertion tube to place the tampon inside the vagina beyond the constriction muscles. The cover can inhibit oxygen and carbon dioxide from migrating into the buffer during insertion. A flexible cover can be used to protect the combination of buffer and inserter 10 against contamination. More particularly, the cover or flexible structure seals the combination of buffer and inserter 10 to prevent oxygen and carbon dioxide from migrating into the buffer before the buffer is inserted (ie, during storage of the buffer and inserter combination). ). The front end of the tampon 20 can be opened by broadening in a funnel configuration by the inserter during insertion. In this inserter, a membrane is secured to the perimeter wall of the front end of the tampon device and extends around the forward end of the insertion cylinder where it is secured in a fused area. The membrane is used to widen the end of the buffer but can also act as a seal on the end of the buffer to inhibit oxygen and carbon dioxide from migrating into the buffer prior to insertion. Conventional buffers are generally compatible with the present invention and some representative buffers are discussed below. The tampon may include cotton fibers, rayon fibers, other suitable materials for the tampons. The body of the tampon may be in the form of a bulb. Alternatively, the tampon may have a rounder geometric shape or other tapered end to facilitate entry into the body. The tampon may have a container therein for retaining additional medication. The container can release medications during the break, which can occur during insertion.

Additionally or alternatively, the buffer can be fully sealed to prevent oxygen and atmospheric carbon dioxide from migrating to the buffer. The buffer can be compressed in a capsule before insertion. The support capsule can be prepared from a variety of non-toxic soluble film-forming materials, such as gelatin. The foam is compressed and inserted into the capsule in a compressed state. The capsule is preferably made of a material that dissolves easily upon contact with moisture. When the capsule is inserted into the vagina, the capsule dissolves and the foam can quickly expand to be in contact with the vaginal periphery. The capsule can inhibit oxygen and carbon dioxide from migrating into the buffer. The inserter can be covered with a laminated film bag impermeable to gases that either the inserter can be made or a sheet of rolled metal. The laminated film bag and laminated metal sheet reduce buffer contamination with ambient oxygen during storage and preferably have a permeation coefficient for nitrogen of less than about 3 x 10"9 (cm3mm) / sec cm2 cm Hg ) and a permeation coefficient for oxygen less than about 1.5 x 10"9 (cm3mm) / sec cm2 cm Hg). According to another embodiment of the invention, a seal is located at the rear end of the plunger 30 in such a way that the inserter can maintain a positive pressure of a biocompatible gas. The hydrostatic pressure within the buffer inserter should be greater than one atmosphere, preferably greater than 1.05 atmospheres, and more preferably greater than 1.1 atmospheres. The pressure inside the tampon inserter should not be too great, otherwise it may result in discomfort for the user when the seal is broken. Suitable gases include, but are not limited to, nitrogen (preferred), neon, argon, helium, fluorinated hydrocarbons, and other biocompatible gases having a vapor pressure greater than one atmosphere at zero degrees centigrade. Carbon dioxide is not adequate because its presence can increase the production of the SCT toxin. To maintain a positive pressure of a biocompatible gas, a seal can be used at the front end of the inserter to ensure that the biocompatible gas does not escape from making atmosphere. The tampon 20 is thus sealed in the inserter. The seal can be made by providing a cover or end cap 120 on the inserter, which is preferably integral with the cylindrical side walls of the inserter. The cover or end cap 120 of the inserter may have radial lines of weakness which break when depressing the plunger 30. A tapered end cover 120 is then preferred for ease of insertion. Another embodiment, shown in Figure 3, has a container 130 disposed between the tampon 20 and the plunger 30. The center container 30 is filled with the pressurized biocompatible such as nitrogen, argon, helium, neon, fluorinated hydrocarbons, and other biocompatible gases. . suitable that have a vapor pressure greater than one atmosphere at zero degrees centigrade. During insertion, when the plunger 30 is depressed, the center container 30 breaks as the container 130 is compressed between the plunger 30 and the buffer 20. The biocompatible gas released from the center vessels 30 inhibits the oxygen and carbon dioxide that migrate to the tampon 20 during insertion. In order to maintain the required internal pressure and reduce the contamination of buffer 20 with ambient oxygen during storage, any material used would preferably have a permeation coefficient for nitrogen of less than 3 x 10"9 (cm3mm) / sec cm2 cm Hg ) and a permeation coefficient for oxygen less than about 1.5 x 10"9 (cm3mm) / sec cm2 cm Hg). Suitable materials to form the inserter include high density polyethylene, nylon 6, polyethylene terephthalate, ethylene-vinyl alcohol copolymer, and polyvinylidene chloride. Nylon 6, PET, and polyvinylidene chloride are the preferred materials. Also suitable would be a laminate having a metal foil layer or the like. According to other embodiments, an effective amount of an antioxidant (also referred to as an oxygen scavenger) can be incorporated into the inserter. The antioxidant will combine with any residual oxygen that was not removed when the inserter was filled with a biocompatible gas and sealed. In addition, the antioxidant will combine with any oxygen that can diffuse later in the inserter. Antioxidant materials are suitable include those having a conjugated double bond such as tocopheres (including vitamin E, which is preferred), sterically hindered phenols (BHT), those materials that are readily oxidized, such as sulfites, ascorbic acid, ferrous sulfate , stannous chloride, and those that can absorb oxygen (for example, by chemiosorption), such as porphyrins. If antioxidants are used it is liquids such as vitamin E, these liquids can be immobilized on the internal surface of the inserter. Mixing vitamin E with the resin used to produce the inserter would be an alternate means of making it available to protect against oxygen. According to yet another embodiment, an oxygen absorber can be incorporated in the material of the inserter. Suitable thermoplastic resins include olefins, polyesters and polyamides. Suitable oxygen scavengers include metal-type agents having a metal such as iron with a major component and organic-type agents having an organic compound such as ascorbic acid as the main component. Those and other suitable thermoplastic resins and oxygen absorbers are disclosed in European patent application EP 0 720 821 A2, the disclosure of which is hereby incorporated by reference. According to another embodiment of the invention, the pad having a reduced oxygen level may also comprise an antioxidant which will combine with or purify any of the residual oxygen molecules not removed from the buffer pad or otherwise replaced by other gases. Additionally, an antioxidant will combine with or purify any of the oxygen molecules present during storage or which diffuse into the buffer during storage, or which may infiltrate into the pad during its insertion into the body. Suitable antioxidants include those having a conjugated double bond, sterically hindered phenols, porphyrins, ascorbic acid, vitamin E, ferrous sulfate, stannous chloride, or any of a variety of known safe anti-oxidants. In addition, because C02 has an effect in promoting the production of the toxic shock syndrome exotoxin, the pads of! invention may further comprise carbon dioxide scavengers such as water to purify any carbon dioxide that is present in or infiltrates the pad. As a further aspect of the present invention, bactericides can be incorporated into the pads with those bactericides that are specific for the Staphylococcus aureus that is preferred. Means such as regulating agents can also be incorporated into the pads to maintain the pH of the fluids absorbed in the buffer in the range of about 2.5 to 5.5. Various methods can be used well within the skill in the art to reduce the level of oxygen in the buffer of the invention. According to these methods, the absorbent pads can be produced and packaged (ie, sealed inside the inserter) under reduced pressure to minimize the level of oxygen and carbon dioxide present in the interstices of the pad. Alternately, or in combination with the production and packing of products under reduced pressure, atmospheric air containing oxygen and carbon dioxide can be replaced with a biocompatible gas such as nitrogen (N2), neon, helium, argon, a fluorinated hydrocarbon, or another suitable biocompatible that has a vapor pressure greater than one atmosphere at zero degrees centigrade and that does not promote the production of the toxic shock syndrome exotoxin. The buffer itself (although inside the inserter) or the buffer / inserter combination can be sealed in a wrap made of plastic, paraffin another material that prevents the infiltration of oxygen and carbon dioxide. The envelope preferably has a permeation coefficient for nitrogen less than about 3 x 10"9 (cm3mm) / sec cm2 cm Hg) and a permeation coefficient for oxygen less than about 1.5 x 10" 9 (cm3mm) / sec cm2 cm Hg). The wrap helps maintain the overpressure of the biocompatible gas inside the buffer and the inserter. The tampon of the present invention may also comprise an overwrap such as the overwrap disclosed by Bair et al., U.S. Patent No. 3,902,493. According to savings of another method, the production and packing of the buffers of the invention can be carried out under conditions wherein the atmospheric air is replaced with a biocompatible gas such as nitrogen, neon, argon, helium, a fluorinated hydrocarbon, or another suitable gas that will have a vapor pressure greater than one atmosphere at zero degrees centigrade. The buffer is preferably packaged or sealed within the inserter in the presence of the biocompatible gases at a high positive pressure such that the infiltration of oxygen and carbon dioxide within the product is minimized. According to yet other embodiments of the invention, oxygen scavengers may be incorporated into the buffers which will have reduced oxygen and carbon dioxide levels during the manufacturing process. The scrubbers will act to clean residual oxygen molecules not removed from the pads or otherwise replaced by other gases. Suitable oxygen scavenging materials include ascorbic acid, vitamin E, ferrous sulfate, stannous chloride, or any of a variety of safe, well-known oxygen scavengers. These scrubbers can be incorporated into the absorbent pads of the invention at levels ranging from about 10 milligrams to about 500 milligrams. In addition, oxygen scavengers can be added to the absorbent pad during the manufacturing process according to well-known methods such as by applying solutions of the scrubbers to the pads and drying the pads. Alternatively, you can add the scrubbers in solutions of water or tocopherol (vitamin E), which act as lubricants. Where oxygen scavengers are added to the pads, the debugging effect can occur both during pad storage as well as after insertion into the body. Alternately, oxygen scavengers that can be incorporated into the package or inserter to inhibit the migration of oxygen to the product during storage. Because carbon dioxide can stimulate the production of toxic shock exotoxin, CO 2 scavengers can also be added to the absorbent pad or packaged to the carbon dioxide scrubber. According to one embodiment of the invention, the water itself is added to the pad as a scavenger for the carbon dioxide, which can then be dissolved in the water to form carbonic acid. An effective amount of carbon dioxide scavengers can be incorporated into the inserter. It is anticipated that numerous variations and modifications of the modalities described above will occur for those ordinary recognitions in the art when one appreciates the teachings of the present disclosure. Therefore, only the limitations as they appear in the appended claims must be placed in them.

Claims (10)

1. A combination of catamenial buffer and inserter comprising a catamenial buffer characterized by having a concentration of oxygen sufficiently reduced to reduce the introduction of oxygen into a vagina during the insertion of said buffer, and an inserter enclosing the buffer and reducing the contamination of the buffer with the environmental oxygen during storage.

2. The tampon and inserter combination according to claim 1, wherein the inserter enclosing the buffer contains a suitable biocompatible gas having a vapor pressure greater than one atmosphere at zero degrees centigrade, wherein the gas does not promote the Exotoxin production of toxic shock syndrome.

3. The buffer and inserter combination according to claim 2, wherein the suitable biocompatible gas is selected from the group consisting of N2, neon, argon, helium, and fluorinated hydrocarbons having a vapor pressure greater than one. atmosphere at zero degrees centigrade.

4. The tampon and inserter combination according to any of the preceding claims, wherein the materials suitable for forming the inserter are polymers having a permeation coefficient for N2 less than 3 x 10 ~ 9 (cm3mm) / sec cm2 cm Hg) and a permeation coefficient for O2 less than 1.5 x 10"9 (cm3mm) / sec cm2 cm Hg.)

5. The combination of buffer and inserter according to any of the preceding claims, wherein the inserter it comprises a sealed cylinder containing the buffer and a means for discharging the buffer at one end of the cylinder, wherein during insertion of the tampon into a vagina the discharge means is depressed in the cylinder by breaking the end of the cylinder distant to the discharge means and introducing the tampon into the vagina

6. The tampon and inserter combination according to claim 5, wherein the means for discharging the buffer and the means for providing the cylinder The seal is selected from the group consisting of a piston and a bellows arranged around the piston, a piston provided with a seal formed between the piston and the cylinder, and a piston wherein said piston and said cylinder are arranged in a packing laminated film outer, said laminated film outer packing having a permeation coefficient for nitrogen less than about 3 x 10"9 (cm3mm) / sec cm2 cm Hg) and a permeation coefficient for oxygen less than about 1.5 x 10"9 (cm3mm) / sec cm2 cm Hg).

7. The tampon buffer combination according to any of the preceding claims, wherein an effective antioxidant amount is incorporated into the inserter to maintain the oxygen concentration at an effective level to reduce the introduction of oxygen into the vagina during the insertion of said tampon. The buffer and inserter combination according to claim 7, wherein said antioxidant is selected from the group consisting of compounds comprising double bonds with gavaged, porphyrias, sterically hindered phenols, ascorbic acid, vitamin E, ferrous sulfate , and stannous chloride or mixtures thereof. 9. A method for producing a combination of inserter buffer comprising a catamenial buffer characterized by having a sufficiently reduced oxygen level to reduce the introduction of oxygen into a vagina during the insertion of said tampon, and an inserter enclosing the tampon and reducing Contamination of the buffer with the oxygen of the environment during storage, comprising the steps of (1) producing a catamenial buffer, (2) removing the oxygen present in the buffer, and (3) sealing the buffer with said enclosing inserter the buffer. The method according to claim 9, further comprising the step of replacing the oxygen present in the buffer with a biocompatible gas that does not promote the production of the toxic shock syndrome exotoxin.