CA2722679A1 - Vaginal tissue regeneration device and method for regeneration of vaginal lining using vibration therapy - Google Patents

Abstract

The invention concerns a method of promoting regeneration of vaginal tissue, comprising providing a patient having a vagina in need of vaginal tissue regeneration, vaginal lubricant, and a vaginal regeneration devise comprising: a shaft having a first end and a second end, a tapered insertion at said first end of said shaft and an end cap at said second end of the shaft, and a vibrating mechanism within the shaft;
lubricating the vagina;
inserting the regeneration device into the patient's vagina; activating said vibrating mechanism and allowing the vibrations to contact the vaginal wall for a therapeutic period of time.

The invention further concerns a vaginal regeneration device, comprising: a shaft having a first end, a second end, and a diameter of less than 23 mm along the majority of its length, a tapered insertion at said first end of the shaft and an end cap at said second end of the shaft, and a vibrating mechanism within the shaft, wherein said vibrating mechanism produces vibrations in the range of 500-7,000 rpm.

The invention further concerns kits for promoting regeneration of vaginal tissue comprising at least two vaginal regeneration devices having different diameters along the majority of the length of the shaft.

Description

VAGINAL TISSUE REGENERATION DEVICE AND METHOD FOR
REGENERATION OF VAGINAL LINING USING VIBRATION
THERAPY
BACKGROUND OF THE INVENTION

1. FIELD OF THE INVENTION

[0001] The present invention relates generally to therapeutic apparatus for promoting regeneration of vaginal tissue and methods of promoting the regeneration of vaginal tissue, and more particularly to vibrating devices used primarily for regeneration of vaginal lining and methods of using vibrating apparatus for the regeneration of vaginal lining.

2. DESCRIPTION OF RELATED ART

[0002] A variety of factors can contribute to cause degeneration or weakening of vaginal tissue including changes related to aging, cancer treatments and surgery, among other causes.

[0003] One of the physiologic features of menopause is that blood flow to the vagina ebbs. Atrophic vaginitis, a condition caused by a decrease in estrogen production after menopause which subsequently leads to a decrease in blood flow in vaginal tissues, results in poor tissue regeneration and an increasingly fragile vaginal structure. This decrease in blood flow is largely due to the waning vasodilation effect of estrogen.
Although one generally thinks of estrogen's "classical" genomic steroidal actions, estrogen also affects the body through "rapid-action" mechanisms. One of the best-described rapid actions of estrogen is the ability to stimulate endothelial nitric oxide synthase (hereafter "eNOS") in vascular endothelial cells, causing increased blood flow through increased nitric-oxide dependent vasodilation.

[0004] Lower blood flow leads to 1) decreased skin repair capability, 2) decreased flexibility of connective tissue in the vulva and vagina, 3) decreased vaginal lubrication, and 4) more difficult arousal activation. This is in part because other consequences of depressed estrogen involve an increase in inflammatory reactive oxygen species (vascular, mitochondrial and angiotensin II-related production), depressed mitochondrial function, and decreased tissue regeneration and repair, including depressed collagen synthesis by fibroblasts.

[0005] Although systemic administration of estrogen is sometimes used to combat these issues, other women need or prefer to use non-hormonal alternatives for renewing or maintaining their vulvovaginal health.

[0006] Radiation therapy to the pelvic region often results in changes to the vagina such as thinning of the vaginal epithelium and fibrosis, in addition to foreshortening and stenosis of the vagina. Radiation also disturbs the future ability of the vaginal tissue to form new blood vessels (angiogenesis) and diminishes the size and number of small blood vessels within the vagina, decreasing vaginal lubrication production.

[0007] Chemotherapeutic treatment modalities can also cause adverse changes to the vagina. Tamoxifen is a selective estrogen receptor blocker which can block the rapid action effects of estrogen, resulting in decreased vaginal lubrication and decreased vaginal blood flow. Tamoxifen also enhances aging of the vaginal mucosa and reduction of vaginal flexibility. Over time continued therapy with Tamoxifen may make vaginal penetration uncomfortable or impossible in some cases without treatment.

[0008] A physical alternative is the use of dilators. However, known dilators have several drawbacks. First, many dilators have a large amount of taper along a significant part of their length. This can represent a problem because some women need a device that can penetrate the complete length of the vaginal canal without significant change in diameter. Unlike surgical or radiotherapy interventions where women sometimes experience a foreshortening of the vagina, women transitioning through menopausal changes (naturally or from medical therapy) are more likely to experience a decrease in diameter along the whole length of the vagina. These women need consistently narrow devices that are long enough to penetrate the full length of the contracted portion of the vagina. A dilator that has any significant taper along the shaft would either be too narrow toward the tip to be effective deep in the vagina, or would be too wide toward the base and uncomfortable in use.

[0009] Second, although they are called "dilators" the common therapeutic use, and thus the aim of the design of many dilators, is not actually to widen the vagina but to deepen it.
Where damaged or weakened vaginal walls are a focus of treatment it is desirable to increase passive blood flow, and thus tissue regeneration, by gently and repeatedly distending the vaginal wall laterally rather than just by depth of penetration. However, many devices intended for vaginal insertion are difficult for all but the most motivated and physically capable women to maneuver from side to side to accomplish the desired low frequency repetition of pressure laterally on the vaginal walls. Some women with very severe thickening of the vaginal wall from radiation simply cannot manipulate the dilators laterally successfully: the angles and physical coordination and flexibility required are too much for some women to accomplish. This is compounded for women of advancing age who suffer from arthritis issues preventing them from comfortably gripping the dilator, or from flexing their spine enough to reach their vulva comfortably.

[0010] The difficulties and limitations suggested in the preceding are not intended to be exhaustive, but rather are exemplary of the devices which demonstrate that, despite attention in the art to improving vaginal therapeutic treatment devices, the devices and methods in the art will admit to useful improvements.

SUMMARY OF THE INVENTION

[0011] It has been discovered that low frequency vibration therapy facilitates angiogenesis, thereby synergistically boosting the healing effects of massage therapy using a vaginal insertion device to assist in vaginal regeneration. It is therefore an object of the present invention to provide vaginal regeneration devices that have a generally consistent length and minimal tapering along most of the portion that is intended to be inserted into the vagina (the shaft), that can be made to vibrate at a low frequency, preferably in the range of 500-7,000 rpm, more preferably in the range of 1,000 - 1,700 rpm, and permitting that frequency to be varied within a therapeutic range by the user, and that can be made in a variety of diameters to accommodate different women's vaginal dimensions, including a very small diameter shaft, preferably in the range of 15 mm to 21 mm, to accommodate more severely constricted vaginal walls.

[0012] It is another object of the present invention to provide methods of promoting regeneration of vaginal tissue comprising applying a lubricating material to the vagina of a female patient desiring vaginal tissue regeneration or to a vibrating device made for vaginal insertion that can be made to vibrate at low frequency, preferably in the range of 500-7,000 rpm, more preferably in the range of 1,000 - 1,700 rpm, inserting the device and permitting the device to vibrate against the walls of the vagina for a therapeutic period of time, preferably for at least 5 minutes, and repeating this process on a frequent basis as tolerated by the patient, preferably at least once a day.

[0013] One embodiment of the present invention is a method of promoting regeneration of vaginal tissue, comprising: providing: a patient having a vagina in need of vaginal tissue regeneration, vaginal lubricant, and a vaginal regeneration devise comprising:
a shaft having a first end and a second end, a tapered insertion at said first end of said shaft, an end cap at said second end of the shaft, and a vibrating mechanism within the shaft, applying the vaginal lubricant to the vagina or to the regeneration device;
inserting the regeneration device into the vagina; and activating said vibrating mechanism.
In a preferred embodiment the method further comprises allowing the regeneration device to remain in the vagina for between 1 and 20 minutes, and more preferably for at least 5 minutes.

[0014] In one embodiment of a method of promoting regeneration of vaginal tissue the shaft has a length of between 110 mm and 190 mm. In preferred embodiment the shaft has a length of between 115 mm and 140 mm.

[0015] In another embodiment of a method of promoting regeneration of vaginal tissue the vibrating mechanism provides vibrations at a speed of between 500 rpm and 7,000 rpm, and preferably the vibrating mechanism provides vibrations at a speed of between 1,000 rpm and 1,700 rpm.

[0016] In one embodiment of a method of promoting regeneration of vaginal tissue the shaft has an average diameter of less than 21 mm. In an alternative embodiment the shaft has an average diameter in the range from 21 mm to 27 mm. In another alternative embodiment the shaft has an average diameter in the range from 27 mm to 33 mm.
In yet another alternative embodiment the shaft has an average diameter in the range 33 mm to 42 mm.

[0017] In a preferred embodiment of a method of promoting regeneration of vaginal tissue the shaft has an outer surface that comprises a smooth low friction material.

[0018]Another embodiment of the present invention is a vaginal regeneration device, comprising: a shaft having a first end, a second end, and a diameter of less than 23 mm along the majority of the length of the shaft, a tapered insertion at said first end of the shaft and an end cap at said second end of the shaft, and a vibrating mechanism within the shaft, wherein said vibrating mechanism produces vibrations within the range of 500-7,000 rpm. In a preferred embodiment the vibrating mechanism produces frequencies within the range of 1,000 - 1,700 rpm.

[0019]Another embodiment of the present invention is a vaginal tissue regeneration kit, comprising: a vaginal tissue regeneration device, comprising a shaft having a first end and a second end, a tapered insertion at said first end of said shaft and an end cap at said second end, having an average diameter of less than 23 mm along the majority of the length of the shaft and a vibrating mechanism within the shaft that produces vibrations within the range of 500-7,000 rpm; and vaginal lubrication.

[0020] In one embodiment of the kit the vibrating mechanism produces frequencies within the range of 1,000 - 1,700 rpm.

[0021]Another embodiment of the present invention is a set of vaginal tissue regeneration devices, comprising: a first vaginal tissue regeneration device and a second vaginal tissue regeneration device, each comprising a shaft having a first end and a second end, a tapered insertion at said first end of said shaft and an end cap at said second end, and a vibrating mechanism within the shaft that produces vibrations within the range of 500-7,000 rpm, wherein the average diameter of the shaft of the first vaginal tissue regeneration device is at least 4 mm smaller than the average diameter of the shaft of the second vaginal tissue regeneration device.

[0022] In an alternative embodiment the set of vaginal tissue regeneration devices further comprises a third vaginal tissue regeneration device comprising a shaft having a first end and a second end, a tapered insertion at the first end of the shaft and an end cap at the second end, and a vibrating mechanism within the shaft that produces vibrations within the range of 500-7,000 rpm, wherein the diameter of the shaft of the third vaginal tissue regeneration device is at least 4 mm larger than the diameter of the shaft of the second vaginal tissue regeneration device. In a preferred embodiment the first, second and third vaginal tissue regeneration devices are each different colors.

[0023] These and other aspects of the present invention will become more apparent from the following detailed description of various embodiments of the present invention when viewed in conjunction with the accompanying drawings.

DESCRIPTION OF THE FIGURES

[0024] The foregoing and other objects or features and advantages of the present invention will be made apparent from the following description of embodiments, although not exclusive, embodiments of the invention and from the drawings in which:

[0025] FIG. 1 is a perspective view of a vaginal regeneration device of the present invention.

[0026] FIG. 2 is a perspective view of a vaginal regeneration device of the present invention.

[0027] FIG. 3 is a perspective view of a vaginal regeneration device of the present invention.

[0028] FIG. 4 is a perspective view of a vaginal regeneration device of the present invention.

[0029] FIG. 5 is a perspective view of a vaginal regeneration device of the present invention.

[0030] FIG. 6 is a perspective view of a vaginal regeneration device of the present invention.

[0031] FIG. 7 is a sectional view of a vaginal regeneration device of the present invention.

[0032] FIG. 8 is a sectional view of a vaginal regeneration device of the present invention.

[0033] FIG. 9 is a sectional view of a vaginal regeneration device of the present invention.

[0034] FIG. 10 is a sectional view of the base of a vaginal regeneration device of the present invention that includes the end cap.

[0035] FIG. 11 is a perspective view of a vaginal regeneration device of the present invention.

[0036] FIG. 12 is a perspective view of a vaginal regeneration device of the present invention.

[0037] FIG. 13 is a sectional view of a vaginal regeneration device of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0038] Referring to the drawings in detail wherein like numerals indicate like elements throughout the several views, in FIGS. 1, 2, 3, 4, 5, 6, 11 and 12 wherein are shown perspective views of vaginal tissue regeneration devices 10 of the present invention, in sizes maxi (large) (FIGS. 1 and 4), midi (medium) (FIGS. 2 and 5) slim (small) (FIGS. 3 and 5), and maxi plus (extra large) (FIGS. 11 and 12) wherein a shaft 12 which is preferably elongated, substantially cylindrical and hollow has a first end attached to a tapered insertion 14 which is tapered or rounded for facilitating insertion into a body cavity or orifice, and a second end at which an o-ring 16, preferably made of rubber or another nontoxic flexible water resistant material to prevent moisture from entering the interior of the housing, is positioned between the housing 12 and an end cap 22, which end cap 22 is reversibly attached to the housing 12, to permit access to the cavity within the housing 12. The shaft 12 and tapered insertion 14 together forming a housing. An end cap exterior housing 24 is connected to the end cap 22 opposite the shaft 12 and contains the internal circuitry of unit. A variable speed control dial 18 is positioned on the end cap exterior housing 24 to permit the user to turn the vibration mechanism in the vaginal tissue regeneration device 10 on and off and to vary the intensity of the vibration.
In a preferred embodiment the variable speed control dial controls a rheostat which activates and adjusts the speed of the vibration. In a preferred embodiment a speed variation indicator 20 is also provided that directs the user how to activate and adjust the vibration frequency using the variable speed control dial 18.

[0039] FIGS. 2, 3, 5, and 6 also display a tapered neck 50 at the second end of the shaft 12 between the shaft 12 and the end cap 22 which permits the shaft 12 for medium and smaller sizes to have a smaller diameter along the majority of the length of the shaft 12, which is appropriate for more constricted vaginal openings, while maintaining a larger diameter base which gives sufficient space for control circuitry within the end cap 22 and end cap exterior housing 24 as well as providing a larger base for the user to grip. In this disclosure values for the length of the shaft 12 do not include either the length of the tapered insertion 14 or the length of the tapered neck 50. In a preferred embodiment women in need of vaginal tissue regeneration will first select the vaginal regeneration device 10 having a size that she can insert into her vagina without increasing damage to the tissue, and then, as her vaginal tissue regenerates and her vaginal opening enlarges she may choose to select a slightly larger vaginal regeneration device to continue treatment. For this reason it is contemplated that more than one size of the vaginal regeneration devices, preferably at least 3 or 4 sizes, would be provided to a user sequentially or all together in a kit to permit gradual increase in diameter of the device as the vaginal tissue improves.

[0040] In larger devices, such as that shown in FIGS. 11, 12 and 13, the shaft 12 has a large enough diameter that the end cap 22 is tapered to link the larger diameter shaft 12 to the smaller diameter end cap exterior housing 24.

[0041] FIGS. 7, 8, 9 and 13 are sectional views of large, medium, small, and extra large vaginal regeneration devices 10 of the present invention, respectively, wherein a shaft 12 has at a first end a tapered insertion 14 and at a second end an o-ring 16 positioned between the shaft 12 and an end cap 22. An end cap exterior housing 24 is connected to the end cap 22 opposite the shaft 12. A variable speed control dial 18 is positioned on the end cap exterior housing 24 and a speed variation indicator 20 is also provided. A
vibration mechanism 26 is positioned within the housing, preferably more toward the tapered insertion 14 than the end cap 22, comprising a motor that drives an eccentric counter weight. A power source (28, 30 and 52) preferably one or more battery cells, are provided to drive the vibration mechanism 26. In FIGS. 7 and 8 2 AA cells 28 are shown, in FIG. 9 3 AAA cells 30 are shown, and in FIG. 13 2 C cells are shown, as AA
and larger cells will not fit in some housings having diameter sufficiently small to be used by patients early in their treatment to achieve vaginal tissue regeneration. Within the shaft 12 is shown a battery housing situated between the interior surface of the shaft 12 and the power source 28 and fully encircling the power source 28, which in cross section appears as a first side battery housing 32 and a second side battery housing 34. Motor joints 36, comprising two long slender pieces of metal connect the motor of the vibration mechanism 26 to the Printed Circuit Board Assembly 42 (hereafter "PCBA") via the Printed Circuit Board joint; 38 (hereafter "PCB joint") which PCB joint 38 comprises two slender segmented circular metal contacts electrically connected to the PCBA 42. A
spring joint 40, comprising a small metal spring and slender pieces of metal, is positioned in the end cap so that when a battery is positioned in the shaft 12 the spring joint 40 electrically connects the power source 28 or 30 to the PCBA 42. In preferred embodiments of the present invention an insulator 48 encircles the cavity in which the power source (28 or 30) is located and serves to reduce rattling from the battery during vibration.
Excess noise, such as that produced by battery rattling, can be a deterrent to use, which can adversely effect treatment. The insulator can be composed of any heat stable insulative material with noise dampening effects. In a preferred embodiment the insulator is composed of Ethylene Vinyl Acetate.

[0042] In FIG. 7 a hollow inner housing 46 is positioned within the shaft 12 to provide a smaller inner circumference to securely house the power source 28 in the larger shaft 12 of a larger sized vaginal regeneration device of the present invention that uses a power source 28 sufficiently smaller than the outer diameter of the shaft 12.

[0043] In FIG. 10, a sectional view of the base of a vaginal regeneration device of the present invention, the control circuitry is set forth in more detail. In this particular embodiment an end cap locking mechanism knob 44 projects inward from the end cap 22.
First the end cap 22 is positioned over the base of the shaft 12 so that as the end cap 22 slides onto the shaft 12 the end cap locking mechanism knob 44 fits and slides within a groove located on the outer circumference of the base of the shaft 12 that runs parallel to the long axis of the shaft. Then the end cap 22 is rotated to thread the end cap locking mechanism knob 44 along a groove that runs perpendicular to the long axis of the shaft 12, thereby reversibly locking the end cap 22 onto the shaft. 12.

[0044] Massage gradually introduced directly to aging, damaged or constricted vaginal tissue increases capillary blood flow, which restores regenerative function and results in thicker, more flexible vaginal tissue. Low hertz vibration (preferably in the range of approximately 500 to 7,000 rpm, more preferably in the range of 1,000 to 1,700 rpm) provide deeper vibratory penetration with less superficial friction, causing improvement in blood flow within the vaginal tissue without further damaging the vaginal surface. Over time, this therapy allows for comfortable vaginal penetration during sexual intercourse, as well as facilitating comfortable pelvic exams by health care providers.

[0045] In addition to rebuilding skin integrity and thickness, vibrating massage during dilator therapy for cancer patients who have undergone vaginal or pelvic radiation reduces the stiffness of scar tissue, again allowing comfortable vaginal penetration during sexual intercourse and facilitating comfortable pelvic exams by health care practitioners.

[0046] The vulva may also be affected by menopause, radiotherapy or other sources of damage such that remediation of epidermal and dermal damage is preferably addressed prior to therapy within the vagina. Thus, in the beginning of treatment the focus is preferably on renewing the integrity of the skin and replacing moisture with a genital-safe lubricant. In a preferred embodiment, lubricants are used which offer both moisturizing and sealing properties to allow for the most efficacious use of the device.
Any lubricants with these properties are preferred for use with the device.

[0047] The present invention contemplates methods of vaginal regeneration wherein a vaginal regeneration device as set forth herein is inserted in the vagina of a woman desiring to regenerate an aging, scarred, constricted or otherwise damaged vaginal tissue after lubrication had been applied to either the vagina, the vaginal regeneration device or both. Then the vaginal regeneration device is held within the vagina for a period of time, preferably at least 5 minutes, during at least part of which time the vibrating mechanism is producing low frequency vibrations, (preferably in the range of approximately 500 to 7,000 rpm, more preferably in the range of 1,000 to 1,700 rpm.) In a preferred embodiment these steps are repeated once daily for the first one to three months, then at least thrice weekly thereafter, with daily application offering the best outcome.

[0048] While any biologically compatible lubricant is acceptable for use in methods of the present invention, individual sexual lubricant moisturizing capacities vary widely, with some common lubricants having an osmolality that leaves the skin drier and more fragile than before application. In a preferred embodiment the devices and methods of the present invention are used with lubricants that have an osmolality that does not have an adverse effect on the skin.

[0049] As initial therapy is performed when the tissues are most vulnerable and weak, in one embodiment the application of a moisturizing lubricant is performed with a gentle non-traumatic, non-shear manual pressing into the skin of the vaginal walls. This has the added benefit of mechanically exchanging capillary blood and lymph, and beginning the return of blood flow. This massage and lubricant application is performed from the clitoral hood to the perineum and the large labia to the vaginal introitus. Once this application is non-tender to touch, therapy with the wand series may begin and continue into the vaginal space.

[0050] Because some women experience significant foreshortening of the vaginal space as well as a constriction of diameter from scar formation after traumatic penetration or radiation therapy, many women need a smaller sized vaginal regeneration device for initial use. As comfort increases and vaginal skin condition improves the woman can increase the wand size to improve flexibility for penetration or medical examination.
Thus the present invention contemplates offering the vaginal regeneration devices in a variety of sizes so that the patient may use the appropriate size for her stage of healing.

[0051] In a preferred embodiment of the present invention vaginal regeneration devices are offered in the following average shaft diameter sizes: Slim between 15mm and 23mm, Midi between 23mm and 28mm, Maxi between 28mm and 33mm, and Maxi-Plus between 33mm - 42mm. In a more preferred embodiment, vaginal regeneration devices are offered in the following average shaft diameter sizes: Slim between 16mm and 20mm, Midi between 24mm and 27mm, Maxi between 29mm - 33mm, and Maxi-Plus between 34mm - 41 mm.

[0052] In yet another preferred embodiment, vaginal regeneration devices are offered in the following average shaft diameter sizes, wherein the first measurement represents the approximate diameter of the narrowest part of the shaft 12 that does not include the tapered insertion 14, and the second measurement represents the approximate diameter of the thickest part of shaft 12 where it meets the tapered connection 50 or the end cap 22 where there is no tapered connection 22: Slim: 16mm / 20mm, Midi: 24mm / 27mm, Maxi:
29mm / 33mm, and Maxi-Plus: 34mm / 41 mm. In an additional preferred embodiment devices of varying sizes are provided in different colors to permit the user to easily distinguish which size to use.

[0053] The vaginal regeneration devices of the present invention have a generally consistent length and minimal tapering along the shaft. In a preferred embodiment the shaft diameter decreases by less than 8 mm along its length. For smaller sized devices, where the shaft has an average diameter of 33 mm or less, in a preferred embodiment the shaft diameter decreases by less than 6 mm along it's length. In a more preferred embodiment, where the average shaft diameter is less than 23 mm, shaft diameter decreases by less than 4 mm along its length.

[0054] Women often experience a decrease in vaginal stretch diameter, but may or may not experience any reduction in length. Pelvic radiotherapy patients often experience severe shortening, thickening of the wall and reduction in diameter, often referred to as stenosis, while menopausal women may experience vaginal wall thinning with stenosis but without foreshortening of the vaginal depth. Because of this person-specific need, the vaginal regeneration devices of the present invention are preferably designed to be of sufficient length to penetrate the full depth of most women's vaginas so that the user may choose the appropriate depth of penetration dependent on her unique circumstances. In a preferred embodiment the housing length is in the range of approximately 110mm to 190mm.

[0055] Because each person experiences genital vibration uniquely, it is preferable that the actual frequency is chosen by the user for comfort in use, within a given range.

[0056] The vaginal tissue regeneration methods and devices of the present invention can be used in a doctors office or hospital, but were designed to be particularly useful for home-based therapies specifically to moisturize and recondition the fragile surface of the vaginal epithelium, increase vaginal blood flow by increasing vibratory sheer stress induced release of eNOS, and to rehabilitate the underlying collagen support of the vaginal dermis.

[0057] Low frequency vibration applied to tissue increases blood circulation by increasing capillary dilation, which increased blood flow in turn increases the consumption of oxygen and nutrients by muscles and thereby speeding the regeneration process.

[0058] Utilizing low Hz frequency encourages Nitric Oxide dependent blood flow without inducing high shear forces at the delicate vaginal epithelium area such that remediation is possible without continued superficial trauma. The vibrations are preferably in the range of 500-7,000 rpm, more preferably in the range of 1,000 - 1,700 rpm for therapeutic purposes. The vaginal tissue regeneration methods of the present invention also provide symptomatic improvement without the risk of hormonal exposure as used in other treatment methods, or their concomitant side-effects.

[0059] It is important for efficacy that the portions of the devices of the present invention that are inserted into the vagina have a low friction surface, with imperfections such as seams or other irregularities minimized. This serves to prevent further damage to already delicate tissues. The housing of devices of the present invention is preferably made of a chemically stable, relatively inert, resilient material. Materials that might result in toxicity to the user are preferably avoided. The housing of the device is preferably made of some millable resilient material, and the material is preferably water resistant.
Without limiting the present invention to any particular resilient material, hard plastic such as ABS plastic, acrylic or Lucite are acceptable materials, with medical grade plastic being preferable.

[0060] The vibrating mechanism 26 used in devices of the present invention is commonly comprised of an eccentric weight attached to an electric motor, which is either attached to a battery or can be connected via an electrical cord to a source of electricity, such as a wall outlet. As electricity stimulates the motor to rotate the eccentric mass within the housing of the vaginal regeneration device, the action generates vibrations in the direction perpendicular to the long axis of the shaft, thereby producing a lateral movement that, when the device is placed in the vagina, will provide the desired repetitive gentle pressure on the walls of the vagina to encourage increased blood circulation to the area. By varying the electrical motor and mechanical weight specifications, one can generate a wide range of vibration frequencies and amplitudes.

[0061] It is advantageous for the device to have an adjustable switch that can be used to activate the vibrating motor as well as to adjust the frequency of vibration so that each user can set the appropriate frequency for their therapeutic needs.

[0062] The various embodiments and aspects of embodiments of the invention disclosed herein are to be understood not only in the order and context specifically described in this specification, but to include any order and any combination thereof.
Whenever the context requires, all words used in the singular number shall be deemed to include the plural and vice versa. Whenever the context requires, all options that are listed with the word "and" shall be deemed to include the world "or" and vice versa, and any combination thereof. The titles of the sections of this specification and the sectioning of the text in separated paragraphs are for convenience of reference only and are not to be considered in construing this specification. Insubstantial changes from the claimed subject matter as viewed by a person with ordinary skill in the art, now known or later devised, are expressly contemplated as being equivalent within the scope of the claims.
Therefore, obvious substitutions now or later known to one with ordinary skill in the art are defined to be within the scope of the defined elements.

[0063] In the drawings and specification, there have been disclosed embodiments of the invention, and although specific terms are employed, the terms are used in a descriptive sense only and not for purposes of limitation, the scope of the invention being set forth in the following claims. It must be understood that the illustrated embodiment has been set forth only for the purposes of example and that it should not be taken as limiting the invention.

[0064] In the claims which follow, reference characters used to designate claim steps are provided for convenience of description only, and are not intended to imply any particular order for performing the steps.

[0065] The above specification, examples and data provide a description of the manufacture and use of the embodiments of the present invention. While the devices and related methods have been described in terms of what are presently considered to be the most practical and preferred embodiments, it is to be understood that the disclosure need not be limited to the disclosed embodiments. It is intended to cover various modifications and similar arrangements included within the spirit and scope of the claims, the scope of which should be accorded the broadest interpretation so as to encompass all such modifications and similar structures. Where used, the expression "without limiting the present invention" or the like means that the options listed are not the only options contemplated by the present invention. However, even where such language is not stated, it should be appreciated that the particular implementations shown and described herein are not intended to limit the scope of the invention in any way, but are offered only as examples. Indeed, for the sake of brevity, conventional aspects of embodiments of the invention may not be described in detail herein.

Claims (19)

1. A method of promoting regeneration of vaginal tissue, comprising:
a) Providing:

i) a patient having a vagina in need of vaginal tissue regeneration, ii) vaginal lubricant, and iii) a vaginal regeneration devise comprising: a shaft having a first end and a second end, a tapered insertion at said first end of said shaft, an end cap at said second end of the shaft, and a vibrating mechanism within the shaft, b) applying the vaginal lubricant to the regeneration device;
c) inserting the regeneration device into the vagina; and d) activating said vibrating mechanism.

2. The method of claim 1, further comprising allowing the regeneration device to remain in the vagina for between 1 and 20 minutes.

3. The method of claim 1, further comprising allowing the regeneration device to remain in the vagina for at least 5 minutes.

4. The method of claim 1, wherein the shaft has a length of between 110 mm and mm.

5. The method of claim 1, wherein the shaft has a length of between 115 mm and mm.

6. The method of claim 1, wherein the vibrating mechanism provides vibrations at a speed of between 500 rpm and 7,000 rpm.

7. The method of claim 1, wherein the vibrating mechanism provides vibrations at a speed of between 1,000 rpm and 1,700 rpm.

8. The method of claim 1, wherein the shaft has an average diameter of less than 21 mm.

9. The method of claim 1, wherein the shaft has an average diameter in the range from 21 mm to 27 mm.

10. The method of claim 1, wherein the shaft has an average diameter in the range from 27 mm to 33 mm.

11. The method of claim 1, wherein the shaft has an average diameter in the range 33 mm to 42 mm.

12. The method of claim 1, wherein the shaft has an outer surface that comprises a smooth low friction material.

13. A vaginal regeneration device, comprising: a shaft having a first end, a second end, and a diameter of less than 23 mm along the majority of the length of the shaft, a tapered insertion at said first end of the shaft and an end cap at said second end of the shaft, and a vibrating mechanism within the shaft, wherein said vibrating mechanism produces vibrations within the range of 500-7,000 rpm.

14. The device of claim 13, wherein the vibrating mechanism produces frequencies within the range of 1,000 - 1,700 rpm.

15. A vaginal tissue regeneration kit, comprising:
a) A vaginal tissue regeneration device, comprising a shaft having a first end and a second end, a tapered insertion at said first end of said shaft and an end cap at said second end, having an average diameter of less than 23 mm along the majority of the length of the shaft and a vibrating mechanism within the shaft that produces vibrations within the range of 500-7,000 rpm; and b) Vaginal lubrication.

16. The kit of claim 15, wherein the vibrating mechanism produces frequencies within the range of 1,000 - 1,700 rpm.

17 17. A set of vaginal tissue regeneration devices, comprising: a first vaginal tissue regeneration device and a second vaginal tissue regeneration device, each comprising a shaft having a first end and a second end, a tapered insertion at said first end of said shaft and an end cap at said second end, and a vibrating mechanism within the shaft that produces vibrations within the range of 500-7,000 rpm, wherein the average diameter of the shaft of the first vaginal tissue regeneration device is at least 4 mm smaller than the average diameter of the shaft of the second vaginal tissue regeneration device.

18. The set of vaginal tissue regeneration devices of claim 17, further comprising a third vaginal tissue regeneration device comprising a shaft having a first end and a second end, a tapered insertion at the first end of the shaft and an end cap at the second end, and a vibrating mechanism within the shaft that produces vibrations within the range of 500-7,000 rpm, wherein the diameter of the shaft of the third vaginal tissue regeneration device is at least 4 mm larger than the diameter of the shaft of the second vaginal tissue regeneration device.

19. The set of vaginal tissue regeneration devices of claim 17, wherein the first vaginal tissue regeneration device is a different color from the second vaginal tissue regeneration device.