A catamenial tampon is used by women for the collection of body fluids discharged during female menstruation. As such, tampons are designed to be inserted into the vaginal cavity for the duration of menstruation in order to collect the discharged body fluids therefrom.

Once fluids are collected, a tampon must be removed and replaced if necessary. To this end, tampons are typically constructed with a withdrawal string which is attached to one end of the tampon such that a portion of the string protrudes out of the vaginal cavity when the tampon is in use. Thus, to withdraw a tampon a user pulls the protruding end of the withdrawal string.

Typically, the protruding portion of the withdrawal strings incorporated by prior art tampons are either left unaltered or closed into a loop by forming a knot adjacent to the free end thereof. When a woman wishes to remove a tampon from her vaginal cavity, she first needs to locate the protruding portion of the string in order to subsequently effect withdrawal.

Several limitations are associated with the available tampon withdrawal strings.

Since the protruding end of the withdrawal string is free to move around, it is not always immediately locatable by the user. In addition, a tampon is at times, difficult to remove, particularly when it has collected fluids to its full capacity, thus withdrawing such a tampon using a withdrawal string which may be wet and as such slippery can be a difficult task.

Furthermore, a woman may forget or may be unsure about whether she removed her tampon or not. In such cases, if the woman cannot locate the tampon withdrawal string, a physician visit might be necessary to verify the presence or absence of the tampon.

In more extreme cases, a woman may forget she carries a tampon, and as a result inserts a second tampon, or engages in sexual intercourse.

Another problem typically associated with tampon use is associated with the state of a tampon when in use. It is highly beneficial for a woman to know the current state, in particular, the remaining fluid capacity, of a tampon when in use.

Yet another problem associated with tampon use is that a woman may not always remember exactly when she replaced her tampon. This information may be useful for various purposes. For example, prolonged tampon use, typically, over eight hours, has been associated with the toxic shock syndrome (TSS), a life threatening bacterial infection.

Furthermore, if a tampon is used for applying a medicament intra-vaginally, it may be beneficial to replace it following a pre-determined time period.

Several methods have been described for informing a user about the state of the tampon when in use.

U. S. Pat. No. 3,794,024 to Kokx discloses an indicator in contact with the absorbent body of a catamenial device. The indicator"reads" the wetness of the absorbent body and translates the wetness into a

signal, which can be sensed without removing the catamenial device.

Changes in temperature or color formation are used as indicators.

U. S. Pat. No. 5,361,627 to Levesque discloses a method and apparatus for measuring the capillary attraction developed at a surface of an absorbent body intended to be used in a sanitary article such as a sanitary napkin, a diaper, a urinary pad, an adult brief, a tampon or a wound dressing, among others. The apparatus comprises a probe of fritted glass providing an array of capillary passageways being in fluid communication with the interior of a closed cell completely filled with liquid. A pressure sensor mounted to the closed cell senses the liquid pressure therein. When the probe is placed in contact with the absorbent body, the capillary attraction exerted on the liquid in the probe capillaries by the porous network of the absorbent body is transmitted through the liquid medium in the cell to the pressure sensor. The pressure data thus obtained reflects the state of dryness of the absorbent body surface. The capillary attraction measurement is made with no appreciable transfer of liquid toward the absorbent body to avoid altering its condition.

U. S. Pat. No. 5,468,236 to Everhart discloses a disposable feminine care product which includes a chemically reactive means having an end point adapted to provide a visual indication of the presence of a substance in mammalian bodily excrement.

The above described configurations are limited because in order to be informed a user must locate the withdrawal string of the tampon, which, as further detailed hereinabove, may prove as a difficult task.

PCT application No. US98/20257 (WO publication 99/17692) describes a tampon wetness, substances and other parameters detection system including tampon implanted sensors which signal to a remote-reporting device of the wetness of the tampon, of presence and/or concentration of specific the substances and/or the parameters magnitude.

There is thus a widely recognized need for, and it would be highly advantageous to have, a more effective tampon withdrawal string, which can facilitate the effortless identification and removal of a tampon while at the same time be used for providing information to the user, such as for example, real time information relating to the capacity of the tampon when in use.

SUMMARY OF THE INVENTION According to one aspect of the present invention there is provided a tampon assembly comprising (a) an absorbent body having a distal and a proximal end, the absorbent body being shaped and sized for insertion into a body cavity and being for collecting discharged body fluids when positioned within the body cavity; and (b) a withdrawal string being attached through the distal end of the absorbent body and having a thickening provided on a distal portion thereof, the withdrawal string being of a length such that when the absorbent body is positioned within the body cavity the distal portion is positioned outside the body, the thickening being for indicating to a user the presence of the absorbent body within the body cavity and further being for enabling the withdrawal of the absorbent body from the body cavity.

According to another aspect of the present invention there is provided a method of using a tampon assembly comprising the steps of (a) providing a tampon assembly including (i) an absorbent body having a distal end and a proximal end, the absorbent body being shaped and sized for insertion into a body cavity and being for collecting discharged body fluids when positioned within the body cavity; and (ii) a withdrawal string being attached through the distal end of the absorbent body and having a thickening provided on a distal portion thereof, the withdrawal string being of a length such that when the absorbent body is positioned

within the body cavity its distal portion is positioned outside the body; (b) positioning the absorbent body within the body cavity; and (c) following use, withdrawing the absorbent body from the body cavity by locating the thickening and pulling the withdrawal string via the thickening so as to effect withdrawal of the absorbent body from the body cavity.

According to further features in preferred embodiments of the invention described below, the thickening is selected from the group consisting of a bead, a button, a knob, and a sticker.

According to still further features in the described preferred embodiments the thickening includes an adhesive such that the thickening can be adhered to the skin or underwear of a user when the absorbent body is positioned within the body cavity.

According to still further features in the described preferred embodiments the thickening has a specific gravity higher than that of water either when wet (e. g., sponge and the like) or when dry.

According to still further features in the described preferred embodiments the thickening is shaped and sized so as to ensure that the distal portion of the withdrawal string is not drawn into the body cavity when the absorbent body is positioned within the body cavity.

According to still further features in the described preferred embodiments the thickening is constructed of an anti slippery material.

According to still further features in the described preferred embodiments the thickening has a rough surface.

According to still further features in the described preferred embodiments the thickening includes a mechanism for indicating elapsed time.

According to still further features in the described preferred embodiments the indication of elapsed time is provided via a visual change in color presented by the thickening.

According to still further features in the described preferred embodiments the indication of elapsed time is provided via a visual change in color density presented by the thickening.

According to still further features in the described preferred embodiments the indication of elapsed time is provided via a visual change in a pattern presented by the thickening.

According to still further features in the described preferred embodiments the thickening includes a mechanism for indicating at least one parameter of said absorbent body or discharged body fluids.

According to still further features in the described preferred embodiments the at least one parameter is a wetness level of the absorbent body and further wherein at least one wetness level is indicatable via a change in color presented by the thickening.

According to still further features in the described preferred embodiments each of the at least one wetness level is indicated via a change in color density presented by the thickening.

According to still further features in the described preferred embodiments the tampon assembly further comprising a parameter detection system including at least one sensor being within the absorbent body for sensing a parameter of a fluid being absorbed thereby, a transmitter communicating with the at least one sensor for transmitting information pertaining to the parameter extracorporeally and an extracorporeal reporting device for relaying the information to a user.

According to still further features in the described preferred embodiments the transmitter is within the thickening.

According to still further features in the described preferred embodiments the parameter is correlated to menorrhagia, menstrual cycle disorders and their causes, whereas the at least one sensor is constructed

to specifically sense the parameter correlated to menorrhagia, ovulation, pregnancy, menstrual cycle disorders and their causes.

According to still further features in the described preferred embodiments the parameter is wetness, whereas the at least one sensor is a wetness sensor.

According to still further features in the described preferred embodiments the at least one sensor is selected from the group consisting of a blood sensor, a sugar sensor, a hormone sensor, a mineral sensor, an ion sensor, a salt sensor, a protein sensor, a toxin sensor, a microorganism sensor, a temperature sensor, a wetness sensor and a pH sensor.

The present invention successfully addresses the shortcomings of the presently known configurations by providing a tampon assembly incorporating an improved withdrawal string including a thickening which provides information to a user as to the state of the tampon absorbent body when in use and also serves as a hold, through which easy withdrawal of the tampon absorbent body from within a body cavity can be conveniently and efficiently effected.

BRIEF DESCRIPTION OF THE DRAWINGS The invention is herein described, by way of example only, with reference to the accompanying drawings, wherein: FIG. 1 is a schematic depiction of a tampon assembly according to the present invention; FIG. 2 is a schematic depiction of a mechanism through which sensed information is displayed on a withdrawal string thickening of the tampon assembly according to the present invention;

FIG. 3 is a schematic depiction of a transmitting sensing system implanted within the tampon assembly according to the present invention; and FIG. 4 is a schematic depiction of another configuration of the transmitting sensing system implanted within the tampon assembly according to the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention is of an improved tampon assembly including a withdrawal string which can be used for an effortless withdrawal of a tampon's absorbent body from within a body cavity while, at the same time, provide the user with information pertaining to the status of the tampon when in use. Specifically, the withdrawal string of the tampon assembly of the present invention can be used to provide a user with an indication as to both the presence and the status of an implanted tampon, and at the same time provide a non-slip hold for effecting an effortless withdrawal of the implanted tampon's absorbent body.

The principles and operation of an improved tampon assembly according to the present invention may be better understood with reference to the drawings and accompanying descriptions.

Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

As used herein the term"tampon"refers to any article with absorbent capabilities, which is insertable within a body cavity and used for hygienic, medical or diagnostic purposes.

Referring now to the drawings, Figure 1 illustrates a tampon assembly according to the present invention which is referred to hereinbelow as tampon assembly 10 or assembly 10.

Tampon assembly 10 according to the present invention is employed within a body cavity such as a vaginal cavity and is used for the collection of discharged body fluids such as menses.

Tampon assembly 10 includes an absorbent body 12 which has a distal end 14 and a proximal end 16. Absorbent body 12 is shaped and sized for insertion into a body cavity. As such, body 12 can be, for example, cylindrically shaped when utilized as a catamenial tampon.

When positioned within a body cavity, absorbent body 12 serves for collecting discharged body fluids. According to a preferred embodiment of the present invention assembly 10 is a catamenial tampon and as such absorbent body 12 is used for collecting menses from a vaginal cavity.

Tampon assembly 10 further includes a withdrawal string 18.

String 18 is attached at a proximal end 20 thereof to distal end 14 of absorbent body 12. Alternatively, string 18 can be attached to any portion of absorbent body 12 including packing string 18 within absorbent body 12, as further described in U. S. Pat. No. 3,863,636, or by other means described, for example, in U. S. Pat. No. 4,490,894. String 18 is selected of a length such that when absorbent body 12 is positioned within a body cavity a distal portion 24 of string 18 is positioned outside the body. Suitable lengths for string 18 range, for example, from about 5 to about 15 cm, however lengths outside this range are also envisaged.

String 18 of assembly 10 according to the present invention has a thickening 22, attached to, or integrally formed with, distal portion 24. In

its simpler configuration, thickening 22 serves for indicating to a user the presence of absorbent body 12 within the body cavity, in case such presence is forgotten, as is some times the case. Thickening 22 further serves for enabling an effortless withdrawal of absorbent body 12 from the body cavity.

Combining thickening 22 and string 18 can be effected according to the present invention by any one of a plurality of ways. For example, a pre-formed thickening can be attached at an end of a string.

Alternatively, a plurality of thickenings can be attached spaced apart to a single string, which is thereafter cut to form individual strings supplemented with a thickening at their distal end. The thickening may be attached to the string in any one of a plurality of ways known in the art, for example, by stringing the thickening; by positioning it via a knot formed in the string, by gluing is to the string, by melting it onto the string, by clamping it onto the string, by attaching it using a spring or spring action. Furthermore, a thickening may be formed by weaving a distal end of a string end into a bulge or by chemically or physically forming a thickening on the string.

To provide an indication as to the presence of absorbent body 12 within a body cavity thickening 22 is constructed such that it is easily recognizable and locatable by the user. Thickening 22 can be brightly colored and/or luminescent and in addition constructed of a size large enough to be visually or tactily recognized by the user, while at the same time provide user comfort. In addition, the type of tampon and/or specific properties thereof, such as absorbent capabilities can be color-coded. According to one embodiment of the present invention, thickening 22 can be shaped as a bead, a button, a disk, a ring, a knob, T-bar, a heart, a cross, a star of David or an emulate, such as a hamsa, an

eye, a fish a horseshoe and the like. Other designs are also envisaged.

Fragrance, such as perfume, releasing thickening 22 is also envisaged.

According to a preferred embodiment of the present invention thickening 22 includes an adhesive allowing thickening 22 to be reversibly attached to the skin or underwear of a user when absorbent body 12 is positioned within the body cavity. Thus, according to this embodiment of the present invention thickening 12 can be shaped as an adhesive sticker or of any flattened adhesable shape which is readily amenable to attachment via the adhesive to the skin and/or to material from which undergarments are constructed. Alternatively, thickening 22 can include a Velcro hook fastener such that thickening 22 can be attached to an undergarment or to the pubic hair of a user.

As mentioned above, thickening 22 also serves for providing the user with a non-slip hold allowing absorbent body 12 to be easily withdrawn from the body cavity. To this end, thickening 22 is formed of a size and shape, which can be firmly griped by the fingers of the user.

For example, thickening 22 can be formed with a rough, spiny or corrugated surface or of a material which is not slippery when wet, so as to allow the user a firm grip even when thickening 22 is wet. It will be appreciated that since tampon assembly 10 is utilized for the collection of body fluids, string 18 and thickening 22 can come in contact with discharged body fluids.

In addition, and according to another preferred embodiment of the present invention, thickening 22 is shaped and sized so as to ensure that distal portion 24 of withdrawal string 18 is not drawn into the body cavity when absorbent body 12 is positioned within the body cavity. In this case, thickening 22 is formed of a size large enough to prevent unwanted withdrawal of distal portion 24 into the body cavity, while at the same time this size is selected in consideration with user comfort.

It will be appreciated that the above mentioned embodiments of thickening 22 provide assembly 10 of the present invention a clear and distinct advantage over prior art devices. According to preferred embodiments the present invention thickening 22 (i) provides an indication if assembly 10 is implanted within a body cavity, a feature which is particularly advantageous since the absents of such indication can lead to problems as further discussed hereinabove; (ii) enables a firm grip of withdrawal string 18 and as such enable effortless withdrawal of absorbent body 12 out of the body cavity, a feature which is particularly advantageous when absorbent body 12 is saturated to capacity and as such difficult to withdraw; (iii) enables withdrawal of absorbent body 12 from the body cavity even when string 18 and thickening 22 are wet; and (iv) prevents unwanted migration of distal portion 24 into the body cavity.

According to another preferred embodiment of the present invention, thickening 22 is formed of a material of a higher specific gravity than water and as such thickening 22 will submerge in water. It will be appreciated that following use, assembly 10 may be discarded through the sewage system, in such a case it is desired that assembly 10 or any part of, does not float. In addition, thickening 22 is preferably formed of a biodegradable or ultra violet degradable material.

According to another preferred embodiment of the present invention, thickening 22 includes a mechanism for indicating elapsed time. It will be appreciated that elapsed time indication is particularly advantageous when assembly 10 is only effectively usable for a predetermined time period such as in case of a catamenial tampon. In such a case, timely discardment or replacement is crucial for preventing problems associated with prolonged use of a non-replaced tampon.

There are many examples in the art of devices for indicating elapsed time, which can be incorporated into thickening 22.

According to preferred embodiments of the present invention indication of elapsed time is provided via a visual change in color, color density, color pattern and/or color area coverage. As used herein in the specification and in the claims section that follows, the term"color"also refers to colorless.

For example, U. S. Pat. No. 4,028,876 which is incorporated herein by reference, discloses an apparatus for visually indicating elapsed time by a color change. Such an apparatus includes first and second chromophoric compound that are combined with one another through a matrix which controls the rate of combination of the compounds so that a color body is produced by the reaction of the compounds over a period of time that may be adjustable from anywhere from about several hours to about thirty days.

Another example of an apparatus for time lapse indication is disclosed in U. S. Pat. No. 4,824,827 which is incorporated herein by reference. U. S. Pat. No. 4,824,827 describes end point indicator compositions and devices including them, which compositions contain a polar indicator dye which assumes a first color (e. g., colorless) in the presence of a room temperature volatilizable solvent. Such a solvent is initially present in excess along with a small amount of a proton-donating compound. The indicator dye assumes a second color visually distinct from the first color in the presence of the proton donating after the majority of the solvent escapes from the remainder of the composition.

According to another embodiment of the present invention indication of elapsed time is provided via a visual change in a pattern.

For example, U. S. Pat. No. 5,058,088 which is incorporated herein by reference describes a device which can be utilized for measuring time

elapsed by providing a visual change in a pattern and/or coverage area formed by, for example, ink dots. As time elapses the ink forming the dots, which are placed distant from each other, bleeds and as a result the dots enlarge and a visual change in the pattern can form a perceivable image. Directional migration of ink is also envisaged. Since such devices are utilized to preferably measure elapsed time from the initiation of use, their timing mechanism is designed to be either initiated by the user, by, for example, pressing thickening 22, or by exposing thickening 22 to light, for example, when assembly 10 is removed from a light shielding packaging in preparation for use.

According to another preferred embodiment of the present invention, and as specifically shown in Figure 2, assembly 10 includes a mechanism for displaying information pertaining to, for example, the wetness level of absorbent body 12. According to this embodiment of the present invention such information is displayed to the user by thickening 12.

For example, information pertaining to the wetness level of absorbent body 12 can be relayed to thickening 22 through capillary movement of a collected fluid which can be mediated by string 18 or preferably by an inner and highly absorbent wick 26 positioned within string 18 and which is in physical contact with absorbent body 12. Such information is displayed on or in thickening 22 in a manner readily interpretable by a user and can include color information pattern information and the like.

It will be appreciated, that an assembly 10 which can display wetness level information in combination with the time elapsed information further described hereinabove, is particularly advantageous.

The amount of menstrual flow varies with time within a single menstrual period. Usually this flow is heavy during the first few days, decreasing

towards the end. As such, it is advantageous for a woman to utilize a tampon having a capacity which matches the flow at any specific time during her menstrual period. To do so, a woman needs to be able to determine the time elapsed from the last tampon application, and the amount of menstrual fluid collected by the tampon. Such information can be provided by the features of assembly 10 of the present invention.

In addition, and as already mentioned hereinabove, an indication of the type of tampon and/or specific properties thereof, such as absorbent capabilities can be displayed by thickening 22, so as to allow easy identification of such variations in an assortment of tampons of varying capacities.

According to another preferred embodiment of the present invention, and as specifically shown in Figure 3, assembly 10 includes a sensing system 40 implanted within absorbent body 12. Sensing system 40 serves for sensing and relaying to a user parameters associated with absorbent body 12 such the wetness level thereof, substance composition of the discharged body fluids collected thereby and physical/chemical parameters thereof, such as, but not limited to, temperature and pH of the discharged body fluids.

According to one embodiment, system 40 includes a transmitter 48 which according to this embodiment is implemented within housing 42. Transmitter 48 is preferably a radio frequency transmitter. System 40 further includes at least one sensor 50 (four are shown) which is designed to sense the presence of a specific component included in the discharged menses. One example is of a sensor designed to sense water or humidity. Other examples include sensors designed for detecting one or more substances such as, but not limited to blood, sugars, minerals, ions, salts, proteins, toxins, microorganisms, and the like, or one or more parameters, such as, but not limited to, temperature, wetness or pH.

Miniaturized temperature, pH and other ions or salt sensors are well known in the art. For example, a temperature sensor is adapted at sensing a heat magnitude and converting it into an electrical parameter (e. g., resistance, voltage, etc.) of a magnitude corresponding to the heat.

Thermistors thus operating are distributed, for example, by Beta Therm Cat. # 1K7A1. A glucose sensor according to the present invention is preferably a glucose oxidase based glucose sensor, which sensor includes a potentiostat and an electronic chip for quantifying the glucose level in the menses. The operation of these components is well known in the art.

Prior art glucose sensors are distributed by, for example, LifeScan Inc. and MediSense Inc. USA. Other sensors are also known in the art and can be miniaturized to fit into System 40.

Sensor 50 is in electrical communication with transmitter 48, such that when sensor 50 senses a parameter such as, for example, wetness, transmitter 48 is operable to transmit such information to a remote-reporting device 52. Transmitter 48 is operated via a power source 51, such as, for example, a battery or a transducer such as a radio frequency or magnetic field transducer which responds to an extracorporeal energizing signal produced, for example, by device 52, which power source 51 can be used to power sensor (s) 50 as well.

Remote-reporting device 52 includes a receiver 54 for receiving the signal transmitted from sensor (s) 50. Remote-reporting device 52 further includes a reporting unit 56 for interpreting and reporting to a user the information received by receiver 54. According to another preferred embodiment of the present invention and as specifically shown in Figure 4, transmitter 48 is implanted within thickening 22 and is in communication with sensor (s) 50 through electricity conducting wires 54 implanted within withdrawal string 18. In this case, information sensed by sensor (s) 50 is transmitted from thickening 22, which as already

mentioned above is positioned outside the body when absorbent body 12 is positioned inside the body cavity. Thus, this configuration presents a clear advantage over the configuration shown in Figure 3 because the transmitter, in this case, is positioned outside the body and as such it is not shielded by the body and as a result less transmission power is necessary to generate a receivable signal. In addition, according to this embodiment of the present invention power source 51 is also located within thickening 22.

PCT application No. US98/20257 (WO publication 99/17692) and U. S. Pat. application No. 09/182,193 both are incorporated herein by reference provide further detail on the configurations presented in Figures 3-4.

Incorporation of a sensing system within assembly 10 of the present invention is particularly advantageous, since absorbent body 12 is used to collect body fluids such as menses and as such, it is important to know the wetness level of absorbent body 12 and the state of the fluids collected thereby. This information can serve as indication as to the remaining fluid capacity of assembly 12 and as such can be used by a user to determine when assembly 12 should be discarded or replaced.

Furthermore, information pertaining to the state of the fluids collected, such as pH, temperature composition and the like can serve for example, as indication of menorrhagia, menstrual cycle, ovulation, pregnancy and other physiological disorders and conditions and their causes.

Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art.

Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.