CN104470485B - For promoting the apparatus and method of female sexual health - Google Patents

Abstract

This invention relates to devices, systems, and methods for promoting female sexual health and function. The devices, systems, and methods combine vibrational stimulation with suction on the clitoris to promote clitoral engorgement.

Description

Devices and methods for promoting female sexual health

technical field

Embodiments of the present invention relate generally to devices and methods, and more particularly to promoting female sexual health and function. In particular, certain embodiments facilitate promoting, assisting, stimulating or enhancing female sexual desire, arousal or satisfaction.

Background technique

Clitoral vascular engorgement plays an important role in female libido, arousal, and satisfaction. Sexual arousal causes smooth muscle relaxation and arterial vasodilation in the clitoris. The resulting increased blood flow swells the glans and increases sexual arousal. A variety of conditions can lead to insufficient clitoral erection and decreased blood flow to the clitoral arteries. This in turn can make it difficult or impossible to swell the clitoris. A lack of subjective arousal, reproductive lubrication, or orgasm can also negatively affect a woman's sexual health.

The incidence of symptoms ranging from dissatisfaction to dysfunction was higher in women. For example, according to the National Health and Social Life Survey, among 1,749 women aged 18 to 59, 43% had sexual experience. Furthermore, female sexual dysfunction varies with age, is progressive and very common, affecting 30% to 50% of women, and 68% to 75% of women experience sexual dissatisfaction or sexual "problems" "(non-congenital sexual dysfunction). In a national survey of more than 31,000 women in the United States, 44.2% of women reported experiencing sexual problems. According to other surveys, more than 53 million women (43% of the U.S. population) reported having one or more sexual problems, and more than 14 million women met clinical criteria for female sexual dysfunction (FSD), by far the most A common problem is low libido (reported by 46 million women). (See, for example, Incidence and prevalence of the sexual dysfunctions of Spector I and Carey M.: a critical review of the empirical literature, 19:389-408, 1990; Prevalence of sexual dysfunction in women by Rosen RC, TaylorJF and Leiblum SR et al. :results of a survey study of 329women in an outpatient gynecological clinic, J.Sex.Mar.Ther.19:171-188, 1993; Read S, King M and Watson J's Sexual dysfunction inprimary medical care:prevalence,characteristics and detection by the general practitioner, J. Public Health Med.19:387-391, 1997; Laumann E, Paik A, and Rosen R, Sexual Dysfunction in the United States Prevalance and Predictors, JAMA, 1281:537-544; Read S, King M, and Watson J. Sexual dysfunction in primary medical care: prevalence, characteristics and detection by the general practitioner, J PublicHealth Med., 1997;19:387-91; Schein M, Zyzanski SJ, Levine S, Medaile JH, Dickman RL, and Alemagno SA's The Frequency of sexual problems among family practicepatients, Fam Pract Res J. 1988;7:122-34; Sexual problems and distress i by Shifren JL, Monz BU, Russo PA, Segreti A and Johannes CB n United States women: prevalence and correlates, Obstet Gynecol. 2008: 112(5): 970-978; Shifren, Obstet Gynecol 2008; 112: 970-8. These publications are hereby incorporated by reference.

Research shows that an adequate blood supply is required for good vaginal and clitoral function and a satisfying sexual experience at any age. Women at risk for female sexual dysfunction include: women who use birth control pills, women with poor vascular health (eg, women with diabetes, high cholesterol, high blood pressure), aging women, and those who are undergoing or have undergone radiation therapy for cancer (radiation therapy for cancer may severely reduce lubrication, hormone levels, and/or genital pleasure). Use of birth control pills can reduce circulating levels of testosterone needed to regulate blood flow to the genitals and stimulate libido, and can lead to long-term permanent sex hormone deficiency. Moreover, the prevalence of sexual problems increased sharply with age, with 27.2% of women aged 18-44, 44.6% of women aged 45-64, and 80.1% of women aged 65 and over reporting sexual problems.

While most male and female sex organs are similar, subtle structural differences make females more sensitive to inhibitors. While the male glans and the female glans similarly have the highest density of sensory receptors compared to the rest of the body, the male anatomy provides the glans with more extensive structural support. This structure can be used to support male sexual dysfunction by dilating or enhancing the vein-trapping function of the corpus cavernosum. In contrast, the absence of hyperemic anatomical maintenance in women renders women more sensitive to many potent inhibitors. Although female corpus cavernosum initially becomes hyperemic during stimulation (see Figure 29), it does not remain hyperemic to the same extent as male anatomy.

Figure 30 illustrates a variety of factors that can act as inhibitors or enhancers of sufficiency stimuli. For example, Figure 30 exemplifies how sensory and psychological factors (eg, a woman's well-being in her relationship with her partner and emotional or visual cues) drive central nervous system (CNS)-mediated facilitation or inhibition (indicated by +/- signs) . Other health factors, such as diabetes or coronary heart disease, or factors such as drugs can drive other inhibition or facilitation. This multifactorial network makes developing a safe drug to treat women challenging.

The female sexual response cycle affects the incidence of female satisfactory sexual experience (SSE). The cycle includes the following states: (i) emotional and physical satisfaction, resulting in (ii) emotional intimacy, causing (iii) receptivity to sexual stimulation, causing (iv) sexual arousal, causing (v) arousal and desire, which makes Cycle back to a state of (i) emotional and physical fulfillment. Spontaneous sexual arousal can occur between state (ii) and state (iii), between state (iii) and state (iv), and/or between state (iv) and state (v).

These and other challenges can be addressed by embodiments of the present invention.

Contents of the invention

Certain embodiments of the present invention relate to methods for promoting female sexual arousal; clitoral engorgement using suction combined with vibratory stimulation; providing variable customizable control of vibration and suction; based on a stimulator mounted on a flexible membrane to provide Novel power-tissue optimization schemes; providing novel forms of suction connection in combination with multifocal actuators; and systems or methods providing novel actuators for mechanical movement and suction.

Certain embodiments of the invention relate to systems or methods for providing a tissue contacting chamber and at least two stimulators coupled to and controlled by the tissue contacting chamber such that a user experiences spatially differentiated stimulation. The system can include a suction port in fluid communication with the interior of the tissue contacting chamber. The system may include a suction adjustment mechanism integrally formed with the tissue contacting cavity. The system can include a piston positioned within the tissue-contacting chamber and configured to regulate suction within the tissue-contacting chamber. The system can include a sealing surface coupled to the tissue-contacting cavity and configured to maintain a substantially hermetic seal against the tissue. The system may include a controller and/or a remote. The system may include parameters controlling the stimulator selected from the group consisting of vibration frequency, vibration intensity, vibration duration, motor vibration sequence, and combinations thereof. The system may include controlling the stimulator by selecting a pre-programmed algorithm, a user-defined algorithm, or a combination thereof. The system can include a suction generating device and a wearable device body, wherein the suction generating device is detachable from the wearable device body. The system can include that the device body remains substantially in contact with tissue after detachment of the suction generating device. The system may include a membrane at least partially encapsulating at least one of the stimulators. The system can include the membrane coupled to the cavity. The system may include the membrane being configured to be replaced by a user's clitoris. The system may include controlling the stimulator such that a user experiences simulated macroscopic motion. The system may include the stimulator generating macroscopic motion when in contact with the tissue. The system may include separation of vibrations generated by one stimulator from vibrations generated by another stimulator. The system may include decoupling vibrations generated by a stimulator from a wall of the tissue contacting chamber. The system may include maintaining at least one stimulator in direct contact with the user's clitoris during application of suction.

Certain embodiments of the invention relate to systems or methods that provide a mechanically stabilized housing, a suction lumen within the housing, and a plurality of stimulators. The system can include a low profile housing. The system may include a housing configured to be wearable. The system can include a stimulator configured to provide multiple stimuli. The system may include a stimulator configured to provide a combination of macroscopic motion and vibration stimulation. The system may include a stimulator configured to generate a stroking motion.

Certain embodiments of the present invention relate to systems or methods of providing a tissue contacting chamber comprising a suction chamber fluidly connected to a programmable suction pump, and at least two stimulators mounted within the suction chamber, wherein the motor and The suction pump is configured to be independently controllable via a control circuit. The system may include a controller block including a preload vibration mode and a preload suction mode. The system may include the controller block configured to enable a user to create a vibration pattern and a suction pattern. The system may include a wearable body and a suction pump mounted within the device body. The system may include a controller block configured to enable a user to set the first suction level and the second suction level. The system may include a controller block configured to enable a user to set a rate at which the suction pump alternates between the first suction level and the second suction level.

Description of drawings

1A-1D illustrate various views of a device according to an embodiment of the present invention.

2A-2D illustrate various views of internal components of a device according to an embodiment of the invention.

Figure 3A illustrates a film according to an embodiment of the invention.

Figure 3B illustrates a perspective view of the body-attached side of a device according to an embodiment of the present invention.

Figure 3C illustrates a close-up perspective view of the body-attached side of a device according to an embodiment of the present invention.

Figure 4A illustrates a perspective view of the interior of a lumen of a device and an associated stimulator in accordance with an embodiment of the present invention.

Figure 4B illustrates a perspective view of the exterior of a lumen portion of a device and an associated stimulator in accordance with an embodiment of the present invention.

Figure 5A illustrates a perspective view of the interior of a lumen of a device and an associated stimulator in accordance with an embodiment of the present invention.

Figure 5B illustrates a perspective view of the exterior of a lumen portion of a device and an associated stimulator in accordance with an embodiment of the present invention.

Figure 6 illustrates a stimulator and a vibration isolator of a device according to an embodiment of the present invention.

Figure 7 illustrates wearable clothing and devices according to embodiments of the present invention.

8A-8C illustrate various views of devices according to embodiments of the invention.

8A'-8C' illustrate various views of devices according to embodiments of the present invention.

Figure 9 illustrates a portion of an apparatus configured to provide macroscopic motion according to an embodiment of the present invention.

Figure 10 illustrates a portion of an apparatus configured to provide macroscopic motion according to another embodiment of the present invention.

Figure 11 illustrates a device configured to provide macroscopic motion in accordance with an embodiment of the present invention.

Figure 12 illustrates a perspective view of a device according to another embodiment of the present invention.

Figure 13 illustrates a cross-sectional view of a device according to another embodiment of the present invention.

14A and 14B illustrate views of a device and components of the device according to another embodiment of the present invention.

15A and 15B illustrate views of an apparatus according to another embodiment of the present invention.

Fig. 16 illustrates a view of an apparatus according to another embodiment of the present invention.

Fig. 17 illustrates a view of a device according to another embodiment of the present invention.

18A and 18B illustrate perspective views of a device and detachable suction element according to another embodiment of the present invention.

Figure 19 illustrates a cross-sectional view of a device according to another embodiment of the present invention.

Figure 20 illustrates a cross-sectional view of a device and a perspective view of a controller according to another embodiment of the present invention.

Figures 21 and 22 illustrate a stimulator and lever arrangement according to an embodiment of the present invention.

23A and 23B illustrate a device for providing macroscopic motion according to an embodiment of the present invention.

24A-24D illustrate various views of devices according to embodiments of the present invention.

25A and 25B illustrate a charging station and device according to an embodiment of the present invention.

Figure 25C illustrates a charging station and device according to another embodiment of the present invention.

26A and 26B illustrate views of devices and controllers according to embodiments of the present invention.

27A and 27B illustrate various views of a device according to an embodiment of the invention.

Figure 28 illustrates a view of an apparatus according to an embodiment of the present invention.

Figure 29 illustrates a view of a specific portion of the human female anatomy in relation to an embodiment of the present invention.

Figure 30 is a flow diagram illustrating various inhibitors and enhancers of a satisfying sexual experience and their interdependence.

31A-31C exemplify the relationship between hyperemia and vibration propagation.

32A-32E illustrate the application of multiple embodiments of the present invention.

Figure 33 is a partial cross-sectional view of another embodiment of the present invention.

34A-34D are side views of some specific embodiments with different tissue contact arrangements.

35A and 35B are top views of a device with a removable flange assembly.

Figure 36 is a perspective view of a removable flange assembly.

37A and 37B illustrate a removable flange assembly including a flange membrane.

Figure 38A is a side view of a removable flange assembly.

38B and 38C are side and perspective views, respectively, of a cross-section of the removable flange assembly of FIG. 38 .

Figure 39 is a top view of the flexible membrane of the suction chamber.

Figure 40 is a perspective inside view of the integrated device.

41A and 41B illustrate a device body configured to comfortably and securely fit a user in a variety of situations.

Figure 42 is a perspective view of a device including an onboard hand pump.

43A-43K illustrate various embodiments of sealing flange assemblies.

44A-44C illustrate a user interface of a smartphone-style controller.

45A and 45B illustrate side and partial interior views of a device with a motor in the body of the device.

Figure 46 illustrates a device with multiple motors that are free to vibrate and impinge on a tissue cavity.

47A-47D illustrate the arrangement of stimulation elements used in the device.

48A-48C illustrate stylus stimulation systems and complementary stimulation arrangements.

49A-49C illustrate a motor and end effector system for stimulating tissue within a tissue lumen or aspiration lumen.

50A-50D illustrate an arrangement of end effectors in combination with at least one motor and at least one coupler for stimulating tissue.

51A and 51B illustrate two views of a spatially differentiated resonant element driven by one or more motors.

Figures 52A-52D illustrate various embodiments of devices with stabilizing, adhesive and/or immobilizing components.

Figure 53 illustrates an embodiment of a device capable of simultaneous vaginal and clitoral engagement and stimulation.

Figures 54A-54D illustrate an embodiment of a clitoral engorgement chamber and its associated device body.

detailed description

Embodiments of the present invention described herein, including figures and examples, are useful for promoting female sexual health and sexual function.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited.

A brief summary of certain terms is given in the present specification. Each term is further explained and exemplified in the description, drawings and examples. Any interpretation of the terms in this specification should take into account the entire specification, drawings and examples attached hereto.

The singular terms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to a subject(s) can include plural subject(s) unless the context clearly dictates otherwise. Likewise, reference to a plurality of object(s) can include a single object(s) unless the context clearly dictates otherwise.

As used herein, the terms "substantially" and "substantially" mean to a considerable extent or extent. The term, when used in connection with an event or circumstance, can refer to instances in which said event or circumstance occurs, as well as instances in which said event or circumstance is about to occur, such as to illustrate typical latitude or variability of the embodiments described herein. situation.

The term "about" means that a value, amount, degree is approximately or close to a referenced value. The range of variation of the referenced value encompassed by the term "about" is very typical for the tolerance or measurement conditions.

The term "stimulator" refers to an element that provides stimulation using mechanical motion (eg, vibration), electrical stimulation, temperature, or other sensory stimulation.

Healthy females have specific biomolecular and anatomical structures to produce engorgement of vulvar and clitoral erectile tissue. These molecules and structures help stiffen the underbelly, thereby stretching the clitoral nerve. The stiffening effect is to allow for a stiffer protrusion and presentation of clitoral structures due to stimulation, as well as to mechanically allow energy waves to travel across the surface more efficiently and allow less energy to be absorbed by the tissue. Thus, erection of the clitoris via mechanical stimuli such as deflection and vibration transmits these forces through the taut surface of the structure rather than being lost within the loose connective tissue. Thus, methods used to create a hyperemic environment (eg, via drugs or suction) can enhance pleasure and produce other reflex responses (eg, lubrication and oxytocin release). Further, the type and distribution of sensory nerve endings in and around clitoral tissue explains why certain movements, pressure, vibrations, and other stimuli deliver pleasure better than others. Both vibration and suction stimulate hyperemia via the nitrous oxide pathway and thus both increase sensitivity to sexual stimulation. The two employ different neural/physiological pathways. The additive effect is achieved with a dual trigger combining vibration and suction. Pasini's corpuscles, known as Farber's receptors, signal in response to vibratory "pressure" (via pressure wave conduction of tissue vibrations), i.e., a reflexive response. Embodiments of the pumping elements described herein are utilized The stretched NOS pathway in the same structure in hyperemia. Movement/sliding in repetitive patterns can also generate "stress" patterns and vibratory neural signaling. Nerves adapt quickly to stimulation, so vibrations at one point are often not as effective, so moving the position of the vibration, either manually or automatically, is beneficial. All of the above are mediated by DH-testosterone and other hormonal components (thus, testosterone therapy can help increase the mass of the tissue and its "activity"), however, through mechanical stimulation (either by suction and vibration, or by suction and Vibration) We found that many hormonal pathways can be bypassed and a reflex response can be directly triggered.

We have found that simultaneous hyperemia and vibration are a powerful combination, such that hyperemia forms a more suitable mechanical backplate for the Pasini bodies to be stimulated, and that simultaneous hyperemia and vibration produce more than either alone better effect. In both sexes, genital engorgement is a key physiological indicator because engorgement is fundamental to achieving SSE. As shown in Figures 31A-31C, vibrational energy propagates better along a strained, congested matrix. Embodiments described herein provide methods and devices for engorging sexual organs for better transmission of vibrational energy.

Certain stimulation devices of the prior art, such as vibrators, provide relatively diffuse stimulation. In other words, the vibratory motion provided by the vibrator acts relatively evenly on the clitoris and surrounding tissue. In certain vibratory devices that can deliver vibrations over a more concentrated area, the frequency and amplitude of the vibrations can still achieve relatively dispersed vibrations to the clitoral tissue. Furthermore, most of the vibrations of prior art vibrators are lost in vibrations to the handle, housing and the user's hand or other parts of their body.

Advantageously, certain embodiments described herein are capable of providing multi-mode suction. Such complex mode waveforms can provide a comparable organ stimulation experience compared to prior art mechanical stimulation devices. For some users, the variable pumping patterns, algorithmic waveforms of certain embodiments can provide hyperemia and stimulation for effective arousal without the use of vibration.

Advantageously, the embodiments described herein are capable of providing spatially differentiated vibratory motion compared to prior art devices. In other words, women can experience spatially differentiated vibratory movements. In certain embodiments, this spatially differentiated vibratory motion mimics the sensation of macroscopic motion around the clitoris. Macroscopic movements can be understood as similar to stroking movements, tongue movements, or movements consistent with sexual intercourse. For some users, the spatially differentiated vibratory motion of certain embodiments can provide engorgement and stimulation, enabling effective arousal without the use of suction.

One aspect of spatially differentiated stimulation is the separation of stimuli generated by a stimulator from stimuli generated by another, neighboring stimulator. By isolating the stimuli generated by one motor from the stimuli generated by the other, the device simulates and/or mimics macroscopic movements around the clitoris. Another aspect of spatially differentiated stimulation is to isolate the stimulus generated by the stimulator from the housing, which minimizes stimulus loss and focuses the stimulus on the desired tissue.

Another advantage of isolating vibrations in devices according to embodiments described herein is that the small device can be worn discreetly while producing little noise while applying focused and isolated vibrations and engorgement of clitoral tissue.

Certain embodiments of the devices described herein employ suction to contact tissue with a vibrating element. Certain devices remain in contact with the tissue by virtue of the suction applied to the tissue. Another advantage of isolating vibration in the device is that the hermetic seal between the device and tissue is substantially impervious to vibration. Such vibration isolation involves substantially isolating the sealing elements of the device from the vibrating elements in the device.

The compact devices described herein are such that they can be worn concealed and possibly carried in a purse. However, the size and configuration of the devices described herein are designed to allow easy access and control when worn. The devices described herein can be used before and during intercourse or as a supplemental blood flow and tissue nerve sensitization program. The devices described herein are adjustable and customizable and can provide selectable variable suction and vibration characteristics. The devices described herein can be remotely controlled, for example, via a smartphone. The devices described herein are capable of promoting and/or maintaining female sexual arousal.

Advantageously, the devices described herein employ relatively low power motors to generate concentrated, spatially differentiated vibrations.

According to certain embodiments, the device has some or all of the following characteristics: (i) has a snug fit; (ii) moderate stimulation; (iii) is sufficiently comfortable or tolerable; and (iv) is reliable and safe to operate.

In terms of a comfortable fit, a device with a comfortable fit can exhibit the following attributes: (i) the device can be worn while ambulatory without a tether or additional clothing; (ii) the device is sized such that the fit is large under the The area of attachment between the labia and the shell can exit the labia majora over the clitoris; (iii) the device continues to fit throughout engorgement; and (iv) the device is wearable during intercourse. Further, the device may be configured such that a portion of the device placed behind the labia majora is sufficient to hold the device securely in place, with or without additional suction.

According to certain embodiments, a comfortable fit can be achieved by providing some or all of the following parameters: (i) the design and center of gravity of the device are such that the device remains fixed to tissue without a tether for at least 15 minutes; (ii) the device can is worn under clothing; (iii) the mass of the device allows attachment by suction only; (iv) the device can be in the correct position for at least 5 minutes without adjustment; (v) the device has a smooth tissue interface area; ( vi) the device remains in the correct position when standing and walking while wearing the device; (vii) the footprint of the attachment area of the device is anatomically appropriate; (viii) the device is designed to fit at least the clitoral region of a female; (ix) the device is tissue The expansion provides space; (x) the outer device envelope allows for concealed use; (xi) the device is designed so that it does not block or restrict access to the vaginal opening; (xii) the device body is able to withstand pressure against a soft surface (such as , body) forces; (xiii) the height of the device does not restrict partner interaction, and its edge geometry is comfortable for both partners.

In certain embodiments, the device may be properly positioned by activating one or more motors to vibrate to a detectable level to allow the user to focus the stimulating effect around the clitoris. By pre-activating the motor during placement, the user can customize the fit and determine where vibration simulation and/or suction stimulation are most effective.

In terms of appropriate stimulation, a device with appropriate stimulation may exhibit one or more of the following properties: (i) the device applies suction to the vulvar area, or more specifically the clitoral area, to promote engorgement of clitoral tissue; (ii) the device can apply vibratory energy to at least the clitoral tissue area; and (iii) the device provides sufficient time for stimulation to achieve a desired level of sexual arousal.

According to particular embodiments, appropriate stimulation may be achieved by providing some or all of the following parameters: (i) the device provides suction in the range of about 0.7 to 9 (Hg) to the clitoral region; (ii) the device provides suction in the presence of pubic hair Suction is provided using optionally added body lubricant; (iii) the device maintains the selected level of suction for at least 5 minutes; (iv) the user can use a wireless remote control to control the level and mode of suction; (v) The device generates vibrations in the frequency range of 100-300 Hz; (vi) the vibrational force (peak-to-peak) under load promotes excitation; (vii) keeps the vibrating element in direct contact with the tissue when suction is applied; (viii) the device Full power stimulation is provided for at least 30 minutes on a single battery charge; and (ix) the device can vibrate to move between sources as pointed by the user.

With regard to comfort and tolerability, a device that is sufficiently comfortable and tolerable exhibits one or more of the following attributes: (i) the device allows the user to release the suction when desired; (ii) the device does not generate too much (iii) the device does not produce irritation to the urethra; and (iv) the device is comfortable to wear, with a tissue-contacting surface that is soft, pliable, and/or smooth without protrusions.

According to certain embodiments, adequate comfort and tolerance may be achieved by providing some or all of the following parameters: (i) the user can release the puff within 5 seconds if desired; The device does not produce more than 70 decibels of noise as measured in feet; and (iii) the device fits the female's vulva or clitoral area without blocking the urethral opening.

With regard to operational reliability and safety, an operationally reliable device exhibits the following attributes: (i) the device presents no risk of electric shock; and (ii) the device allows for proper washing or cleaning after each use.

Depending on the particular embodiment, reliable and safe operation may be achieved by providing some or all of the following parameters: (i) keeping the battery and electronics compartment free from accidental contact with fluid; (ii) the maximum discharge rate of the battery considered non-hazardous; (iii) the service life of the device can be rated at 2-3 years; (iv) the stimulator is rated to be at least adequate for use; (v) the device is waterproof when cleaned according to the recommended method; and (vi) the device avoids contact with tissue /fluid contact areas, or allow access to areas behind the tissue interface for cleaning.

Certain embodiments have some or all of the following features: (i) users can customize the suction and vibration stimulation to suit their needs; (ii) the device can withstand the stress of normal use; and (iii) the device may not have any user Replaceable parts.

Specific device feature aspects may include some or all of the following: (i) users can set the suction to a level that is comfortable for them; straw; (iii) user can control vibration function via wireless remote control; (iv) user interface via iOS, Android or other mobile operating system application on Bluetooth device or via RF or Bluetooth key fob controller (v) User can control vibration parameters, such as: mode switching speed and vibration intensity; (vi) Powered by internal rechargeable battery, out of user reach; (vii) User can control/guidance by finger tapping wireless device vibration concentration point; (viii) user controllable motor overlap; (ix) motor overlap optimized for organoleptic sensation; (x) device capable of basic rotational motor patterns; (xi) device can withstand user applied (above the connection area); (xii) the housing can withstand sufficient vacuum cycling without loss of integrity; (xii) the user can customize the motor mode, including direction, motor selection, circuit and save/return to the custom mode; And (xiv) the user is able to customize the suction pattern and save/return to the custom pattern. Studies have shown that different parts of a woman's brain are activated when she self-stimulates her clitoris compared to partner stimulation, and that women tend to orgasm more easily through self-stimulation compared with partner stimulation. According to certain embodiments of the devices described herein, a female is able to record the stimulation patterns that allow her to self-stimulate to orgasm and store them in the memory of the device. The device can then be used during intercourse to switch on the saved mode, allowing the woman to orgasm as if she were self-stimulating.

Preferred attributes of certain embodiments include: (i) user-adjustable suction for immobilization and supplemental blood flow; (ii) user-adjustable vibration for supplemental blood flow and neurostimulation; (iii) or multiple stimulus sources for isolation & controlled spatially differentiated stimulation; (iv) tether-free and wearable during intercourse; and (v) customizable & reusable.

One embodiment of the device includes: (i) a housing housing the circuitry and battery and connecting the suction zone; (ii) bendable wings for improved connection; (iii) multiple loops attached to the inner wall of the bendable suction zone The stimulator; (iv) a motor isolated from the housing to minimize damping and non-specific vibrations; and (v) suction applied by the removable applicator to move the walls inward to enhance tissue contact.

In one embodiment of the device, the receptacle is coupled to the squeezer to provide suction to the receptacle. The bubble squeezer can be integrally formed with the housing or it can be removed. The receptacle is coupled to an adhesion wing that is capable of interacting with tissue. The wings are anatomically designed and may include, for example, a butterfly-like shape. The wings can help stabilize the device and maintain contact with the device in the relevant anatomy. The edges of the wings and the edges of the tissue in contact with the surface of the device are soft or rounded, or both.

Particular embodiments of the device include onboard circuitry, power supplies, pumps, or other electronic components. For example, the device includes an antenna, such as an RF antenna, that interacts with the remote control. The device includes batteries.

Certain embodiments of the device are controlled by a remote drive connected via a drive cable to vibrating and/or pumping elements within the wearable portion of the device.

As opposed to the high frequency mechanical vibrations of certain prior art devices, certain embodiments of the present invention provide mechanical movements, particularly macroscopic movements, to mimic the movements women naturally use to stimulate the clitoris. Certain embodiments provide multiple stimulation of the clitoris via a stable platform. By mechanically stabilizing a platform, such as through a suction connection, a variety of stimulating effects can be produced directly on the target clitoral tissue. These effects are difficult to achieve on non-mounted platforms. Examples of macroscopic motion include: rotational motion, linear stroking motion, low frequency "whack" motion, and combinations of the above. Macroscopic motion can be combined with vibration, for example, simple vibration or multiple and/or complex waveform vibration.

Certain embodiments of the device provide variable suction. In these embodiments, the user can quickly and easily adjust the level of suction. Further, in certain embodiments, the variable suction is programmable such that the amount of suction applied by the device can be varied according to the mode. In some cases, the suction mode is complementary to the vibration mode and/or the macroscopic motion mode. The device controller includes means for controlling the puff mode, the preload puff mode, the user configurable puff mode, or a combination thereof. The device controller may enable the user to select a preloaded combination of suction modes, vibration modes, and/or macro motion modes, and may also enable the user to design and select a custom combination.

1A, 1B, 1C and 1D illustrate different views of an apparatus 100 according to one embodiment. The device body 110 is designed to fit comfortably and discreetly with the user's body while remaining accessible and controllable. The device body 110 may include on-board controller circuitry (eg, a circuit board) and a user control panel. Alternatively or additionally, the device body 110 may include an antenna for communicating with a remote control device. The device body 110 may include a power source, such as a battery. The device body 110 is coupled with a suction chamber 120 . Suction lumen 120 includes a sealing lip 125 capable of providing a substantially airtight seal to tissue. The sealing edge 125 may be a flange having a width wider than that shown in FIGS. 1A-1D . The suction port 130 is in fluid communication with the interior of the suction chamber 120 and is connected to a suction device (not shown), which creates a negative pressure within the suction chamber 120 . The suction port 130 may also include a check valve or other one-way valve such that the check valve or other one-way valve may prevent loss of suction through the valve when negative pressure is applied to the suction chamber 120 . Optionally, the device body 110 may include an on-board pump system to provide initial suction to the suction chamber 120 . Further, the on-board pump system may further include a pressure sensor that maintains the desired level of negative pressure within the suction chamber 120 despite possible leaks along the sealing lip 125 . Although not shown in an embodiment, device 100 may include a suction lumen, seal, stimulator or other stimulation component or combination thereof, as described in other embodiments herein.

2A, 2B, 2C and 2D illustrate different views of the device 100 according to one embodiment. These figures illustrate the vibration motor 180 arrayed within the suction chamber 120 . In a particular embodiment, vibratory motor 180 is a miniature coin motor having an eccentric rotating mass that provides vibratory motion. The device 100 is designed so that the vibration motor 180 engages the tissue as it is drawn into the suction lumen 120 . The vibration motor 180 may be embedded in the cavity wall of the suction cavity 120 , or the vibration motor 180 may be installed to be connected with the suction cavity 120 . In certain embodiments, it is preferable to minimize vibration transmission from the vibration motor 182 to the suction chamber 120 housing. Preferably, most of the vibration energy is delivered to the tissue contacting the vibration motor 180 . Vibration motor 180 may be vibrationally isolated from the rest of device 100 through the use of a mounting mechanism that dampens transmission of vibrational motion towards the walls of suction chamber 120 . As described herein, the vibratory motors 180 are individually addressable by the controller circuitry so that motion patterns, particularly simulations of macroscopic motion, can be applied to tissue in contact with the vibratory motors.

25A and 25B illustrate a charging station 2000 for a device 2200 and a key fob controller 2300 . Charging station 2000 can be plugged into an outlet via cord 2050 . The device 2200 can be placed in the device cavity 2250 and the controller 2300 can be placed in the controller cavity 2350 . The cavity walls of the cavity may have charging contacts, such as contact 2255, for charging the device battery. Alternatively, the battery of device 2200 may be charged by induction. Charging station 2000 may contain a larger capacity battery charged via cord 2050 that is capable of maintaining a charge and also recharging a smaller capacity battery in device 2200 when charging station 2000 is unplugged from an outlet. The controller 2300 may also be charged using the methods described herein or their equivalents. Figure 25C illustrates the device 200 within a charging clip 2, which has the same attributes as the charging station illustrated in Figures 25A and 25B. In other words, the charging clip 2 can charge the device 200 through induction, contact or other means, and includes a rechargeable battery capable of charging the battery in the device 200 .

FIG. 3A illustrates three vibration motors 180 encapsulated in a membrane 190 . Membrane 190 is configured to be inserted into the suction lumen of the device. Membrane 190 provides a safe, comfortable and reliable shield around vibration motor 180 within the suction chamber. The shield helps reduce tissue irritation and provides a means for cleaning and reusing the device. As shown in FIG. 3B, membrane 190 has a convex shape that defines an interior portion into which tissue is drawn. Membrane 190 has at least one, but preferably more than one, small holes, perforations, slits or combinations thereof to allow deformation of the membrane and air flow. During use, when suction is applied to the suction lumen through the suction port, tissue is drawn into the suction lumen and abuts the membrane 190 . The membrane 190 deforms toward the inside of the suction chamber while maintaining close contact between the vibration motor 180 and the tissue. Figure 3A illustrates two vibration motors configured for serial placement in abutment against tissue. Any number of motors can be used, and these any number of motors can be configured to be placed in series.

FIG. 3B illustrates a perspective view of the tissue contacting side of device 100 according to an embodiment. In this embodiment, the vibrating motors 180 are spaced relatively close together to form a cavity approximately the size of clitoral tissue volume for engagement with the tissue. Figure 3C illustrates a close-up view of the clitoral tissue cavity. The suction inlet 132 is shown at approximately the apex of the clitoral tissue cavity, but the inlet could be offset to one side rather than being exactly at the apex. Further, the suction inlet 132 can be physically offset from the clitoral tissue cavity by a permeable membrane, mesh, or other biasing structure. In other words, a fabric or mesh screen may be provided over the suction inlet 132 to prevent tissue from being drawn into the suction inlet. For example, an expanded PTFE membrane can be used as a biasing structure to provide or maintain a vacuum path between the tissue and the suction inlet. FIG. 3C illustrates a protrusion 133 forming a bias structure. Still further, the suction inlet 132 can be physically offset from the clitoral tissue cavity by a narrow passage that is too narrow for clitoral tissue to pass therethrough. Still further, the suction inlet 132 may comprise a plurality of small diameter suction inlets recessed between protrusions. Bias structures can be combined with each other. Still further, the motor may protrude or protrude from the surface of the flexible membrane (still covered by the membrane) sufficiently to act as a biasing structure that prevents tissue from blocking the suction inlet area. This biasing structure serves to prevent tissue from fully covering the suction inlet 132, which would result in a drop in vacuum flow and damage or cause pain to the tissue.

Figures 3B and 3C show the miniature coin vibrating motor 180 recessed deeply into the membrane 190 such that 1/3 to 1/2 of the motor extends beyond the membrane 190 and towards the tissue. The motor is deeply recessed to bring the motor close to the tissue and provide a deep clitoral tissue cavity. Both the close proximity to the tissue and the deep cavity of the clitoral tissue provide greater stimulation than shallow recessed motors. It is advantageous to transfer as much force as possible from the motor to the tissue, especially in embodiments where the device is held in contact with the tissue by suction. In this embodiment, the loss of force reduces the stimulating effect due to the lower power of the motor, which facilitates efficient force transfer to the tissue.

3B and 3C illustrate channels 192 in membrane 190 that at least partially surround the recessed portion of vibration motor 180 . Channel 192 may be a thin portion of film 190, may be part of a film mold, or may be formed by removing material from the film after molding. Channel 192 is used to help provide and maintain a vacuum path between the tissue and the suction inlet by providing a "leakage path". As noted above, in certain embodiments, it is preferred to maintain a flow path to the suction inlet 132 . Channel 192 also serves to isolate the vibrations of a given motor from the remainder of the membrane and the body of the device. As a thinner region than the surrounding membrane, the channels 192 can be more flexible and reduce or prevent vibrational energy loss that would otherwise be transmitted to thicker but less flexible portions of the membrane. An advantage of minimizing or eliminating vibrations transmitted from the membrane to the device body is avoiding undesirable effects such as: noise, discomfort, reduced irritation and reduced suction (caused by loss of seal provided by the sealing lip).

4A and 4B illustrate views of the suction chamber 120 and the vibration motor 180 according to an embodiment. FIG. 4A illustrates an interior view of the suction chamber 120 and illustrates the stimulation member 185 coupled to the vibration motor 180 . When the tissue is drawn into the suction chamber 120, the stimulation member 185 transfers vibrational energy generated by the vibration motor 180 to the tissue. Stimulation member 185 can have a wide variety of shapes, textures and configurations. Stimulation components 185 may vary within a single device and may be interchangeable, replaceable and customizable. FIG. 4B illustrates an outer surface view of the suction chamber 120 and exemplifies the arrangement of the vibration motor 180 .

5A and 5B illustrate the use of the suction chamber 120 and the micro vibration motor 180 according to an embodiment. In this embodiment, the miniature vibrating motor 180 is a cylinder as compared to a disc-shaped miniature coin motor. Vibration motor 180 is coupled to stimulation component 185 to deliver vibrational energy to tissue.

Fig. 6 illustrates a view of an apparatus according to an embodiment. The stimulators 180 are spaced apart by isolation arms 188 . Isolation arm 188 provides a subassembly into which stimulator 180 may be assembled. Isolation arms 188 are used to isolate the vibrational energy of one stimulator from the vibrational energy of the other stimulator. Isolation arms 188 are useful in situations where the stimulators are activated at different times and/or at different frequencies and/or at different amplitudes. By isolating the vibrational energy generated by one motor from the vibrational energy generated by another motor, macroscopic motion can be simulated on or around tissue. Figure 6 illustrates one type of vibration isolation, but other types and their equivalents are within the scope of the invention.

FIG. 7 illustrates a view of device 100 and an embodiment of garment 50 . In this embodiment, the garment 50 is a simple suspender or belt that is attached to the device 100 and helps maintain the position of the device 100 on the user's body. In certain embodiments, the garment 50 is optional since the device 100 is configured via suction to substantially maintain its position on the user's body. However, it should be understood that for some users, additional means of maintaining the position of the device 100 may be desired. Further, it is to be understood that the device 100 may be configured to be attached to or integrally formed with other garments, including lingerie or other female intimate garments. Jewelry with functional elements that stimulate other areas of the skin can be used to enhance arousal. These functional elements can be one or more of the following: blowing air on the skin, stroking the soft element, and slightly raising or lowering the temperature.

8A, 8A', 8B, 8B', 8C and 8C' illustrate a device 200 according to an embodiment. The device body 210 includes a suction chamber 220 . Suction lumen 220 includes a sealing and stabilizing flange 225 having a sealing lip 226 adapted to provide a substantially airtight seal to tissue. The suction port 230 provides fluid communication between the suction port interior 220 and a suction device (not shown). The device body 210 includes a user control area, which in this embodiment includes an activation button 205 . It should be understood that a user control area may contain multiple control inputs. Further, the device 200 can be remotely controlled. 8B and 8B' illustrate a bottom view of the device 200 and illustrate the interior 220 of the suction chamber. A plurality of stimulators 280 are coupled to the inner wall 220 of the suction chamber. The suction inlet 232 includes a check valve or other one-way valve connecting the suction inlet 232 with the interior 220 of the suction chamber. Figures 8C and 8C' illustrate cross-sectional views of the device 200, illustrating the controller block 215 in addition to the features already described. The controller block 215 is electronically attached to the user control area and/or is remotely controlled by a remote control device via an antenna. The device body 210 provides a safe, secure and comfortable barrier that protects the electronics located in the controller block 215 .

The suction port can be connected to the suction device with a variety of fluid connectors including but not limited to snap fittings, quick release fittings, screw fittings, luer lock fittings, push fit fittings, magnetic couplers and their equivalents .

The device body 210 includes a strong but flexible housing that houses the electronics and couples the electronics to the suction chamber 220 . The device 210 may further include a charging port for recharging the power source included in the controller block 215 . The start button in the user control area can be recessed or made comfortable, safe and secure.

Sealing flange 225 may comprise a soft, bendable flexible material, such as silicone, gel, or closed-cell polyurethane foam, and may optionally adhere gently to tissue or may be adapted to incorporate an adhesive material. Likewise, the foam or other material may contain a lubricant to fill the gap between the sealing flange and the tissue. Other constructions, such as filamentary constructions like velvet or corduroy or other woven or non-woven fabrics, can be used to seal the flanges along with adhesives and/or lubricants to provide a secure fit and help minimize leak paths change. In certain embodiments, the fabric used for the sealing flange may be moisture sensitive, whereby the sealing flange "sticks" or otherwise forms a tight bond with the skin and mucous membranes when the fabric becomes wet. Moisture can come from the user's body or can be applied in the form of lubricants, adhesives, or simply water or saline.

24A, 24B, 24C and 24D illustrate different views of a device 200 according to another embodiment. Device 200 includes a device body 210 and a suction chamber 220 that may house controller circuitry. The controller circuitry may be accessed using an interface mounted on the device body 210 and/or via a remote control. The remote may be physically tethered to the device body 210 or it may be wirelessly connected. Suction body 220 includes a sealing flange 225 adapted to provide a substantially airtight seal to tissue. The various views of FIGS. 24A , 24B, 24C and 24D illustrate certain characteristics of the shape and form of device 200 that facilitate comfortable, discreet and secure attachment of device 200 . For example, the device 200 is sized so that the attachment area (defined by the area where the sealing flange 225 and the suction chamber 220 meet) fits between the labia majora below the clitoris, from which the device body 210 can exit above the clitoris. Further, the taper of the upper section of the suction lumen 220 promotes a comfortable, discreet and secure fit. The curve of the device body 210 may help the device 200 conform to the user and fit discreetly within clothing.

Specifically, the anterior segment 225f of the sealing flange 225 is placed over the clitoris and folded under the anterior commissure of the labia majora. In this position, the labia majora below the anterior commissure can comfortably engage the tapered portion 22Ot of the suction lumen 220 such that nearly the entire anterior and lateral portion of the sealing flange 225 is folded under the labia majora. Advantageously, the tapered portion 220t of the suction lumen 220 allows the labia majora to comfortably engage the relatively narrow portion of the device while vaginal tissue overlying the vaginal opening engages the relatively wide sealing flange 225 .

Proper placement of device 200 is easily and reproducibly achieved through the following steps. For example, when a user first tries to place the device, they may benefit from using a mirror so that the user's head and shoulders are straight and the mirror can be used to observe the placement of the device. The user can open the outer labia so that they can see the inner labia and clitoral hood. The user can identify a lip groove within their outer labia extending along the inner labia at the bottom and the foreskin clitoris at the top. The device 200 can function when the sealing flange 225 is centered on the clitoris and the relatively soft edges of the sealing flange 225 fit into the groove. In some cases, the user can pull hard on their outer labia to make room for the outer ring to fit comfortably into the groove. The vibrating motor then fits comfortably around the glans. In some cases, the user may apply a quantity of lubricant (eg, a water-based lubricant) to the inner and outer labia, the glans, the clitoral hood, and the relatively soft edges of the sealing flange 225 . The user can set the vibrating motor to activate at a lower power to help with placement of the unit. Using the pleasure produced by the low power vibrations as a guide, the user ensures that the clitoris is comfortably positioned within the space defined by the interior of the vibrating motor. In some cases, the user may perform separate stimulation of the inner labia. The positioned device should be high enough on the user's vulva to effectively cover the clitoris without blocking the urethra or vaginal opening.

In certain embodiments, various vibrating disks or miniature coin motors are embedded in the chamber walls of the flexible suction chamber. In a particular embodiment, the motor is embedded in a flexible membrane attached to the lumen wall of the suction lumen. When suction is applied, the tissue is brought into contact with the stimulator. The motor can be controlled by the control circuit to produce one or more of the following modes: (i) all on; (ii) clockwise; (iii) counterclockwise; (iv) up and down; (v) sideways; (vi) all pulse; (vii) selected motor pulse; (viii) frequency ramp; and (ix) amplitude ramp. Transformation of motor vibration modes and spatial isolation can produce the desired effect of simulated macroscopic motion without the need for merging parts that actually move in the macroscopic dimension. Motor mounts may be augmented with stiffening members to divert and/or isolate vibrations. The inner surface of the membrane can be textured to transmit the vibrations to the tissue. The flexible membrane reduces or eliminates the coupling of motor vibrations to the device housing and can increase or maximize energy delivery to tissue.

In one embodiment illustrated in Figure 3B, the pattern is formed by three vibration motors. For example, a rotation pattern (clockwise or counterclockwise) is formed by first activating motor 180a, then activating motor 180b, and finally activating motor 180c. After the motor is activated, it can be completely shut down or its power reduced, so that the high power vibration mode rotates around the motor array. As another example, the V vibration mode is formed by turning on the motor 180a and the motor 180b simultaneously, then turning off the motor 180a and the motor 180b simultaneously, then starting the motor 180a and the motor 180c simultaneously, and finally turning off the motor 180a and the motor 180c simultaneously. The V pattern can be repeated. As another example, sideways mode is created by alternately turning motors 180b and 180c on and off while leaving motor 180a off. As another example, sideways mode is created by alternately activating and deactivating motors 180b and 180c while leaving motor 180a activated.

The above modes and their equivalents can be formed by arrays with more than 3 motors. Rotational patterns, lateral patterns, vertical patterns, and combinations thereof can be formed by selectively activating and deactivating the motors. Regardless of the number of motors present, all modes are within the scope of the invention described herein. Further, in embodiments herein where a vibration motor is illustrated as providing stimulation, other stimulators may be used in place of, or in addition to, the vibration motor. In other words, one or more vibration motors may be replaced by electrical, thermal or other stimulators.

In certain embodiments, various vibration motors form resonance or two-phase amplification. Resonant or biphasic amplified modes can be advantageous because they can create unique vibration modes that are difficult to achieve with a single vibration source, and they can create amplification of vibration power beyond the capacity of a single motor. This amplification may be useful under certain electrical power or space constraints. Resonance or two-phase amplification through the use of multiple vibration sources can be used with different sources including: rotary motors, linear motors, and piezoelectrics. Combining multiple sources creates many customizable and selectable resonance modes. Further, motors of different sizes and/or powers may be used to create multiple resonant frequencies to amplify the vibration effect.

Multiple isolated and independent motors can be combined with each other to generate biphasic amplification or resonant modes and/or can simulate macroscopic motion. The transition between motors is smoother with a sine wave than with a square wave. Optimizing the timing and amplitude of motion during transitions improves the "organic" feel of the stimulus. Preferably, multiple small motors are used to provide easily differentiated stimulation and macroscopic motion simulation. A small eccentric motor placed on the edge provides a concentrated vibration point, which facilitates differentiation between multiple vibration sources. Slower vibration transitions promote differentiation among multiple vibration sources relative to faster transitions.

In certain embodiments, the device provides macroscopic motion in addition to or instead of simulated macroscopic motion.

FIG. 9 illustrates a device 300 that provides macroscopic motion, according to an embodiment. Device 300 includes suction lumen 320 and sealing lip 325, both of which are configured to engage tissue as described herein. In this embodiment, the suction cavity 320 is bendable and deformable such that the motor 380 deforms the suction cavity 320 when traversing the suction cavity 320 via the track 370 . The motor 380 may be coupled to the cylinder or the motor 380 may itself be a cylinder that rolls, slides or moves along the track 370 . Movement of the motor 380 through the suction lumen 320 simulates a stimulating stroking motion and promotes blood flow and/or clitoral engorgement. Suction chamber 320 includes a suction port (not shown) that is used similarly to those described herein and includes a check valve or other one-way valve to maintain suction in the chamber. Since the motor 380 can vibrate in addition to traversing the track 370, it can provide both stroking and vibrating motions.

Figure 10 illustrates an embodiment of a device 400 providing macroscopic motion, according to an embodiment. Device 400 includes a device body 410 and a dome 420 . The dome 420 is configured to rotate relative to the device body 410 about the central axis of both the device body 410 and the dome 420 . Stimulation component 485 is coupled to dome 420 . Suction port 430 operates to provide suction to the interior of device body 410 to bring tissue into contact with stimulation member 485 . A motor (not shown) drives the rotation of the dome 420 relative to the device body 410 and rotates the stimulation member 485 around the clitoral tissue drawn into the interior of the device body 410 . The stimulating member 485 may also be driven by a vibrating motor to provide stroking and vibrating motions.

Alternatively, the movement of the dome may be magnetically driven. For example, dome 420 may include a single bias magnet. The device body 410 may include multiple electromagnets that are individually addressable by the controller. The motion of the dome can be driven by selectively charging individual electromagnets in sequence or in a pattern.

Figure 11 illustrates an embodiment of a device 700 with moving treads 775 beneath a fixed membrane 790 providing macroscopic motion for stimulation. The moving tread 775 fits under the membrane 790, is flexible and bendable, and moves with the components on the tread. Tread 790 has protruding regions 777 spaced from one another at physiologically relevant intervals. The tread rides on two or more rollers 779, at least one of which is powered to rotate the tread.

Fig. 12 illustrates an apparatus 500 according to an embodiment. The device body 510 is attached to a flange 525 configured to maintain a substantially airtight seal with tissue. The tissue-contacting surface of flange 525 may include a mild adhesive, and/or an adhesive substance may be used on the tissue-contacting surface of flange 525 . Optionally, lubricants and/or exothermic substances may be used on the tissue-engaging surface of flange 525 . Flange 525 is flexible and conformable, adapted to provide a secure and comfortable anatomical fit. The device body 510 includes a suction lumen (not shown) capable of sucking tissue into its interior. The device body 510 includes a vibration motor 580 capable of transmitting spatially isolated vibrations to tissue. The device body 510 includes an activation button 505 in a location accessible to the user, eg, outside the suction chamber.

Fig. 13 illustrates an apparatus 600 according to an embodiment. Device 600 includes a suction lumen 620 configured to apply suction to tissue through a suction port or other mechanism described herein. The device 600 includes a stimulator 680 and a power source such as a battery. Stimulator 680 is suspended from suction lumen 620 via adjustment arm 640 . Adjustment arm 640 enables the user to precisely and repeatably control the contact force between stimulator 680 and tissue. Device 600 includes an activation button 605 and may include remote control functionality via an on-board antenna. Alternatively, the adjustment arm may be controlled electronically, such as by applying current through the nitinol wall to control the position of the motor relative to the tissue.

Figures 14A and 14B illustrate an embodiment of a device 800 comprising a flexible membrane 810 designed to transmit pulse waves along its length. The bendable electronic controller 850 drives one or more bendable actuators 860 at least partially encapsulated in the bendable membrane 810 . The flexible membrane may have a curved configuration defining a lumen. Suction may be applied to the lumen by a variety of mechanisms including: a deformable suction lumen 820 attached to the membrane 810 . Optionally, when the film is exposed to air, a mild exothermic reaction occurs to further stimulate blood flow.

In one embodiment of the device, the device can generate a sweeping wave-like motion. The speed and amplitude of the waves are variable, selectable and adjustable in real time. The undulating motion can also be used to deliver therapeutic substances directly to the genital area. These substances can be stored in or immediately after the polymeric adhesive zone. A mechanical displacement algorithm, or alternatively, a delivery-focused algorithm can be used to dose the drug at the desired rate. Thin film actuators include shape memory polymer materials and metal materials, ferroelectric thin films, polymer thin films, piezoelectric films, polymer composite materials/metal composite materials and combinations thereof. The actuators may be powered using light or electromagnetic radiation.

In certain embodiments of the invention, wave-like motion can be achieved by continuously charging the area where the membrane actuator is located. When energy is supplied to each region, the region undergoes a conformational change that causes a local displacement of the structure. Various spatiotemporal patterns can be formed to stimulate stroking movements. Alternatively, some areas may be made to vibrate all other areas to provide a simulated stroking motion. Membranes can be electrically actuatable polymers, piezoelectric materials, shape memory polymers, shape memory metals, or composites containing one or more of the following: metals, polymers, particles, strips, charging elements, water , salt, alkali, acid, etc. In certain embodiments, the membrane actuator is composed of graphite and can be driven by an electrical current to deliver vibrational stimuli, simulated macroscopic motion, and/or macroscopic motion.

15A and 15B illustrate an embodiment including a magnetically coupled thin film actuator 900 and a controller 950 . The membrane actuator 900 is applied to the clitoral hood and the controller 950 is placed into the vaginal vault. The controller 950 transmits variable wave electromagnetic energy to the membrane actuator 900, causing the actuator to vibrate. If the electromagnetic energy is provided by a rotating magnet, the magnet may be eccentric in weight. This eccentricity enables localized vibration or can also be accentuated so that only the membrane actuator vibrates. The film is disposable and includes other magnetically adhesive materials. The controller can be onboard the device or can be remote controlled. The density of the magnetic elements makes the focal point of the actuation variable along the surface. An adhesive layer 910, such as a mild adhesive polymer layer, may be present to bond to tissue. The vibrations are caused by electromagnetic actuation of the magnetic layer 915 present between the adhesive layer 910 and the skin layer 920 . The controller includes power sources such as rotating magnets, motors, circuits, and batteries. The controller can be encapsulated for safety, reliability and comfort.

In another embodiment, the controller may be placed in the interior space of the vagina and may be physically tethered to a device placed near the clitoris. The controller and device may be connected with a malleable connector to allow for comfortable or durable positioning of the device. Advantageously, by moving heavier control and power components from the clitoral device to the vaginal device, the clitoral device can be made more comfortable and wearable. Vaginal devices may also include stimulation components such as vibrating motors.

FIG. 16 illustrates an embodiment of device 1100 with stimulator 1180 in contact with the top or front surface of suction lumen 1120 . Device 1100 includes a flange 1125 that provides a generally airtight seal to tissue while being reasonably comfortable and wearable. Suction lumen 1120 draws tissue into its interior using a separate suction device or by deformation of the suction lumen before device 110 is placed in contact with the tissue. The stimulator 1180 (or more than one stimulator) may be used to stimulate clitoral tissue as the tissue is drawn into the suction chamber 1120 . The stimulator 1180 (or motor) may be controlled via a user control area on the device 1100 or a remote control.

Certain embodiments of the present invention utilize a broadband input, wider than that of certain prior art devices. For example, the input may include complex waveforms such as literary music or superimposed waveforms that make up a "song" type. The multiple amplitudes of the "song" can produce the desired mechanical effect on the actuator in contact with the tissue. The location or spatial placement of these "songs" are differentially distributed across the target tissue surface to produce enhanced effects. For example, some areas are better stimulated by low frequency patterns, while other regions are better stimulated by high frequency patterns. It is also possible to achieve high vibrations by combining high-amplitude modes with variables. By spatially modulating these effects, simulations of manual stimulation, tongue stimulation or sexual intercourse can be achieved. Multiple stimulus features are available to the user to produce different effects. Nominally, certain tissues may respond more to the simulated "rubbing" effect, while other tissues may respond more to more periodic "diving" or thumping effects. The "songs" can be downloaded to a remote player or to the device itself via a web-based media marketplace (eg, iTunes). Figure 17 illustrates a device 1200 that includes an array of acoustic mechanical drivers 1282, or voice coils (eg, "speakers") to create variable types of stimulation on a surface. Each driver 1282 is individually addressable by the controller to generate the complex waveforms and patterns of stimulation described herein.

18A and 18B illustrate the interaction of device 1300 and a separate suction device 1320 . The combination of device 1300 and suction device 1320 provides a kit for use in accordance with the embodiments described herein. Device 1300 includes a suction port 1330 that is in fluid communication with the interior of a suction lumen (not labeled) on device 1300 . While the suction device 1320 is shown as an injection-type suction device, other suction devices are within the scope of the present disclosure. The separate suction device enables precise, repeatable and reliable suction application and makes device 1300 discreet and comfortable to wear.

FIG. 19 illustrates an embodiment of a device 1400 in which the stimulation member 1485 is driven by a motor housed within the body 1410 of the device. The device 1400 is placed in contact with the clitoral tissue by means of a suction device as described herein or by placing the device in intimate contact with the tissue via a garment or clothing-like device. The stimulation component 1485 provides macroscopic motions to stimulate clitoral engorgement by providing more natural stroking motions and/or tongue motions as compared to vibrating motions. Device 1400 may include one or more stimulation components.

In a particular embodiment, the controller is designed to map user motion on the control surface to the tissue contacting surface of the stimulating portion of the device. By pressing a finger on the control surface, the user can generate various pressure levels of vibration at corresponding locations on the tissue contacting surface. As the user optimally moves the fingers across the control surface, a series of motions, pressures, vibrations and/or stimuli imitating these movements are created on the tissue contacting surface. These movements and inputs can be stored locally on the device or at the controller level and can be played when needed to produce the desired effect without requiring the user to repeat their input pattern.

Figure 20 illustrates an embodiment of a device 1500 that can be remotely controlled by a touch panel device 1550 to provide precise and customizable stimuli. The touch panel device 1550 may be a smart phone or other equivalent device. Device 1500 includes an electroactive layer 1580 that contacts tissue either directly or through a membrane. The tissue is drawn into connection with the electroactive layer 1580 by the methods described herein. Device 1500 includes power supply 1515 , local controller 1505 and antenna 1535 . The electroactive layer 1580 is configured to mimic the movement and pressure exerted by a user's finger on the touch panel device 1550 to the clitoral tissue inside the device 1500 .

In certain embodiments, the remote control is configured to send radio frequency signals to controls on a device worn by a user. The controller may be similar in size to a key fob remote typically associated with a car. The key fob remote may include a plurality of buttons capable of controlling all functions of the devices described herein. Figures 26A and 26B illustrate a key fob remote control 206 and device 200 including a complementary housing space 202 so that the remote control 206 can be connected to the device and built into the device when not in use or even in use. In general, the control circuitry may include circuit boards, amplifiers, radio antennas (including Bluetooth antennas).

Devices using Bluetooth Low Energy or other radio antennas may experience disconnection when the remote/device pair is separated by distance or a physical barrier such as the user or their partner's body. In this case, the device is required to remain operational in the pre-disconnect operating condition while the remote attempts to automatically pair with the device again. In other words, it is not desirable to require the user or their partner to manually re-establish the Bluetooth pairing between the remote control and the device if the pairing connection is lost while the device is in use. Also, it is not expected that the device will stop functioning under existing pre-disconnect operating conditions if the mating connection is broken. Accordingly, certain remote controls are configured to automatically re-establish a pairing connection with the device without user intervention.

In cases where the remote automatically re-establishes a pairing connection with the device, it is important that the remote query the device for the current device operating conditions. In other words, since the device remains in the operating condition when the pairing is disconnected, it is expected that the remote control will not interrupt the device operating condition when the pairing connection is re-established. As an inverse example: In some Bluetooth pairings, after the pairing connection is established, the "master" controller sends a reset signal to the "slave" device. Such a reset is not desired where the device is operating under a given parameter, mode or program, which may be interrupted by a reset signal. Such interruptions detract from the user experience.

In particular embodiments, the controller is physically tethered to the device worn by the user. The tethering may include an electrical connection as well as fluid communication to provide suction to the suction lumen of the device.

In certain embodiments, some parts of the device (e.g., suction lumens, arms suspended from vibrating motors, or stimulation chambers) can be manipulated by moving rigid members such as stylets into and out of receiving lumens or in sections of controlled stiffness. component) to control the stiffness.

FIG. 21 illustrates an embodiment of a device in which a stimulator 180 is coupled to the end of a lever 195 . Lever 195 has an inner receiving lumen for receiving a rigid stylet. The stimulator 180 can be more firmly engaged with tissue by a rigid lever 195 that can be attached to the body of the device or to a suction lumen such as the lumen shown in FIG. 13 . FIG. 22 illustrates an embodiment where the lever 195 is coupled to the oscillating motor 180 attached to the suction chamber 120 . The lever 195 is driven with a large movement of its distal end relative to the small movement of the oscillating motor 180 . In this embodiment, the lever 195 utilizes the small movements of the coupled motors to provide the thrill of macroscopic motion.

Figures 23A and 23B illustrate an embodiment in which the stimulator 180 is mounted within the suction chamber 120. Figure 23A illustrates a cross-sectional plan view and illustrates a pump comprising two levers 195 and two pivot points 196. mechanism. The pivot point and lever cooperate to move the stimulator 180 across the target tissue. Although the mechanism is shown with two levers and two pivot points, other combinations of mechanical elements are possible provided they produce a controlled sweeping or stroking motion of the target tissue. FIG. 23B illustrates a cross-sectional end view illustrating the stimulator 180 sweeping across tissue and pivoting about the longitudinal axis of the lever 195 . In certain embodiments, the pivoting motion is passive and conforms to the shape of the tissue to maintain substantial contact between the stimulator 180 and the target tissue. In other embodiments, the pivoting motion is actively controlled and can be used to deliver stronger stimulation forces to the target tissue. For example, as described herein, a miniature coin motor with an eccentric mass transmits stronger forces when placed sideways on tissue. By actively pivoting the motor, a differential force effect can be achieved. The pivot points 196 can be passive or active in the sense that they can be motors capable of driving the sweeping motion or they can be relatively simple joints that allow the motor to move from one point to the other through a driving force in the device. Whisk on tissue.

Certain embodiments of the device deliver suction to engender and stiffen the tissue and vibrations to provide stimulation to the site. In other embodiments, the device delivers suction to engender and stiffen the tissue and electrical or neurostimulation to stimulate the site. In other embodiments, instead of vibratory stimulation or electrical stimulation or neural stimulation or a combination of these stimulations, warming or cooling including light energy or infrared energy (eg, near infrared light emitting diodes) is used. The stimulus is preferably in intimate contact with the tissue to optimize energy delivery.

Mounting the vibration sources may also allow for isolation such that there is a spatial difference between the vibration sources, thereby minimizing the spread of vibration energy to adjacent structures in the device or tissue. Mounting the stimulator on a flexible membrane that moves with the tissue as it is engorged with blood through suction achieves these goals. However, the membrane should have a direct pathway between the source of suction and the tissue, without which the amount of suction delivered will be significantly reduced. Placing small holes or slits in the film allows for sufficient vacuum and energy transfer. However, providing small holes or slits in the membrane allows fluid from tissue to pass through the membrane into the internal vibration source region of the device.

27A and 27B illustrate plan and cross-sectional views of devices according to certain embodiments. The device 200 includes a device body 210 and a suction chamber 220 . Suction lumen 220 includes a sealing flange 225 including a sealing lip 226 adapted to provide a substantially airtight seal to tissue. Suction port 230 provides fluid communication between the interior of suction port 220 and a suction device (not shown), which can be detachable or remain attached. The device body 210 includes a user control area 215 . It should be understood that a user control area may contain multiple control inputs. Further, the device 200 can realize remote control. A plurality of vibration motors 280 are coupled with the inner wall of the suction chamber 220 . The suction inlet 232 includes a duckbill valve 238 (or a check valve or a one-way valve) connecting the suction inlet 232 with the inside of the suction chamber 220 . The device body 210 includes a strong but flexible housing that houses and couples the electronics to the suction chamber 220 . The device body 210 may further include a charging port to recharge the power source included in the controller block 215 . The activation button in the user control area can be embedded or otherwise designed to be comfortable, safe and reliable. Sealing flange 225 may comprise a soft, pliable, and compliant material (eg, silicone), and may optionally be gentle on tissue or may be adapted to include an adhesive material. The device body 210 is configured such that the rear or underside of the device body 210 is in a different plane from the sealing flange 225 . This configuration allows the device body 210 to straddle the user's pubic bone and optionally attach to clothing when the sealing flange 225 is in contact with tissue.

FIG. 27B illustrates the suction tube 231 connecting the suction inlet 232 and the suction inlet 230 . The suction tubing material is chosen to be resistant to adhesion of biological material. The passage of the suction tube through the housing of the device may be configured to reduce pressure and avoid areas where fluid pools are formed. The suction tube provides an additional barrier between the fluid and the electromechanical and electrical components located in the inner housing of the device body.

In embodiments including a suction tube, there is a pressure differential between the cavity above the membrane and the cavity below the membrane. When suction is applied, the pressure in the area above the membrane is higher than the area below the membrane, which can move the membrane down toward the tissue, increasing the contact force between the motor and the tissue. This differential pressure mechanism can be aggressively employed to improve energy transfer.

The problem of clearing fluid from the interior of the device is solved by enabling the flexible portion of the suction cup to be removed from the housing so that it can be self-cleaned by the user. Alternatively, as shown in Figures 27A and 27B, tubing can be connected between the suction luer and the single hole of the membrane. The interior of the hole may have features (eg, protrusions, permeable escutcheons, etc.) that prevent tissue from blocking the hole when vacuum is applied. In this case, fluid cannot enter the inner surface of the device and will be contained in the tissue interface and suction tube channel. These areas can be flushed by the user without disassembly.

To solve this problem of cleaning, in another embodiment as shown in FIG. and clean water. Interior 282 may be vacuum sealed or contain a gel or fluid. The embodiment of device 200 shown in FIG. 33 has a button 284 that is non-deformable. Button 284 has an O-ring 286 to form a seal around the button. The button 284 is mounted on a spring 288 such that when the button 284 is pressed and then released, it is biased towards the home position. Sealing flange 225 forms a seal with female tissue primarily at sealing lip 226 . The suction chamber 220 is a flexible membrane dome that is biased back to its original position. Displacement of the button 284 causes pressure to act downwardly on the elastic membrane dome, which forces gas out of the suction chamber 220 . The tissue-contacting sealing flange 225 acts as a one-way valve, and when the button is released, the elastic membrane tries to return to its original position creating suction under the suction chamber 220 to create negative pressure at the clitoris and facilitate congestion. A biasing member may be added to the suction chamber dome to increase the rebound force.

Figure 28 illustrates a view of the device 200 after the housing has been removed. The controller block 215 (or circuit board) is positioned under the housing between the suction port 230 and the start button 205 . Of course, when it is the I/O port 218 , the activation button 205 is operatively connected to the controller block 215 . I/O port 218 can plug into an interface cable (or, an interface in a holder) that can be used to program and/or charge the device. The battery 212 is located below the controller block 215 .

Certain materials may be preferred for use as actuators in the devices disclosed herein. For example, electroactive polymers expand and contract as electric current is applied, and can incorporate taxels, the visual transistors (foci), to improve resolution. Electroactive polymers can be packed in dense arrays, are highly customizable, and exhibit good frequency ranges. Certain designs are very unobtrusive. Piezoelectric materials are another example. Piezoelectric crystals generate step function activity that can be used for rotational or linear motion and/or vibration. Piezoelectric materials enable miniaturization and incorporation into electronic devices and exhibit good frequency range. Another example is a voice coil, where linear motion is caused by generating an electric field around a magnet. Voice coils are capable of high amplitude low voltage and are smaller than tiny coin cell motors.

Voice coils also allow greater control flexibility than rotary motors because frequency and amplitude can be independent of each other. The voice coil also allows for better vibration energy isolation, since only the moving element is vibrating and the housing is nearly stationary. This enables greater spatial differentiation.

Specific actuator materials can be used to form actuator arrays that provide high spatial resolution for vibrations. For example, providing an array of 14 vibration sources enhances the sensation of motion delivered to the user and provides significant customization patterns. In this example, each vibration node is 4 mm in diameter, which is significantly smaller than the 8-15 mm diameter of the coin cell motor. Vibration nodes with a diameter of 4-6 mm are most suitable for this application to achieve the required resolution.

Certain embodiments can employ vibratory motor arrays to approximate kinesthetic forces (or, macroscopic motion, such as touch or rubbing). The devices disclosed herein enable (or, at least simulate) kinesthetic (or, macroscopic) pleasure by employing actuators that typically only produce haptic pleasure. A device capable of producing a convincing sensory touch pleasure relies on the coordination of: (i) motors spaced in an array (preferably, motors are spaced about 1-4mm apart); (ii) field width of individual motors; (iii) motor The traversal rate of the patterns used; and (iv) overlap.

According to certain embodiments, devices made as described herein are capable of tuning strength, traversal rate, and overlap as fixed physical parameters such as motor spacing, skin contact, and the like. Multiple algorithms allow independent control of motor strength, traversal rate and overlap. In devices made according to embodiments disclosed herein, an algorithm is implemented in a low-cost embedded microcontroller. These algorithm input parameters are finally set by using wireless control of a Bluetooth low energy component that communicates an iOS device (iPhone 5 generation music player) with an embedded microcontroller (Texas Instruments CC2540), with three different input parameters. The modulation algorithm output control type pulse width can drive 3 to 5 motors at the same time. The algorithm also works with unique patterns, allowing the user to specify the order of traversal through the motor array. Different profiles, such as square, sine, and ramp, are used to start different motors at different rates through the motor array, depending on the mode being performed.

For motors with non-linear response curves, feedforward techniques (or feedback, if an inductor is incorporated into the device) can compensate for such response curves. Thus, the motor starts when it is commanded, without hysteresis, enabling the coordination described above. In some embodiments, accelerometers can compensate for the effects of gravity.

A miniature coin-style vibrating motor with an eccentric mass is used in certain embodiments. In general, coin motors require greater mass and higher power in order to increase the stimulation force delivered to the tissue. Therefore, the stimulating force of the eccentric motor is a function of the mass, and higher power is required to drive the mass. In the specific embodiments described herein, despite the higher mass and higher power of the motor, the device can provide spatially differentiated vibration through the isolation structures and methods described herein. Even when the motors are positioned close to each other to provide a tight fit with the clitoris, embodiments described herein can provide substantial vibration isolation and allow the user to experience spatially differentiated stimulation.

In a particular embodiment, a modified voice coil is used as a stimulator. As mentioned above, voice coils enable high amplitude low voltage and are smaller in size than tiny coin cell motors. The voice coil may instead include a mass connected to a membrane driven by an electromagnetic field. Advantageously, such a mass loaded voice coil retains desirable voice coil characteristics including: fast response time, independent frequency and amplitude control, high acceleration, high precision force control and relatively low power consumption.

Embodiments of the device may have variable suction controlled by the user or other remote control. The pressure can be selected remotely by the user and the unit will ramp to the selected pressure within seconds. The device may include an on-board pump that maintains the suction and/or raises or lowers the initially developed suction. Certain diaphragm pumps are available as on-board pumps. Further, the motor driving the diaphragm pump can be used to generate the vibrating motion. In certain embodiments, the on-board pump may be a modified voice coil configured to mimic the action of a diaphragm pump. Alternatively, an on-board pump can be made with a voice coil actuator that moves a membrane into a sealed and valved cavity.

In embodiments employing an on-board pump or embodiments employing a remote pump, suction may be programmed to complement the vibratory motion of the motor in the device or the macroscopic motion of the stimulator. The algorithm for driving vibrations described herein is adapted to a vacuum pump system to provide fast response times and physically differentiable levels of suction to the clitoris. Further, certain embodiments employ simultaneous or sequential suction waveforms or algorithms and vibration waveforms or algorithms to enhance the effectiveness of the device.

In certain embodiments of the apparatus and method, changes in stimulation parameters are particularly useful in providing desired effects to the client. For example, the stimulator can be varied between high power and/or high frequency levels and low power and/or low frequency settings. In the case of coin cell stimulators, power and frequency are linked such that driving the stimulator at a higher vibration frequency also drives the stimulator at higher power. The coin cell stimulator is switchable between a high power threshold and a low power threshold for optimal stimulation variation. In the case of voice coil stimulators, power and frequency can be unrelated such that a stimulus of a given power can be driven at any frequency. Without being limited by a particular mechanism or mode of action, it is believed that widely varying stimulation power or intensity results in a desirable user experience.

One of the advantages of embodiments of the present invention having multiple stimulators and suction patterns is that different anatomical sites can be stimulated at different frequencies. For example, different parts of the frenulum can be stimulated at different frequencies. It is generally understood that different nerve types will be stimulated to different degrees at a given frequency, and that different nerves will be more fully stimulated at different frequencies. One of the advantages of certain embodiments is the ability to deliver appropriate frequency and/or intensity stimulation and/or suction to different locations on the vaginal anatomy. For example, with the three stimulators positioned as shown, the middle stimulator is used primarily to stimulate the glans, while the right and left stimulators are used to stimulate the right and left crura of the clitoris (and/or frenulum) respectively . The device also enables the user to select or adjust the desired frequency for their anatomy and innervation, thereby customizing the user experience.

In certain embodiments, the suction needs to be released during use. For example, the edge of the suction cup can be pulled back, squeezed or manipulated to create a leak channel. Further, the user may manually operate a valve adapted to the suction tube to release the suction. In embodiments employing an on-board suction pump, the pump may be configured to include a constant leak path that the pump overcomes so that if the pump stops, the device will automatically disengage. Still further, the device may be provided with a button that the user presses to open a valve in the pump to release the suction. Still further, the valves required for the suction pump can be normally open. When power is applied, the valve closes, completing the seal. However, if power is lost and the valve is opened, the unit will automatically release.

Certain embodiments of the present invention are designed and configured to increase blood circulation in the vaginal tissue while simultaneously stimulating the clitoris and/or other vaginal tissues in order to promote engorgement of the clitoris and external genitalia. The clitoris is the sex organ, filled with capillaries that supply blood to the densely packed nerves. Certain embodiments increase blood flow to stimulate the clitoris and enhance a woman's sexual response.

In women with symptoms ranging from sexual dissatisfaction to sexual dysfunction, the methods and devices of certain embodiments can provide: (i) increased genital pleasure; (ii) improved vaginal lubrication; (iii) improved sexual satisfaction ; (iv) improved libido; and/or (v) improved orgasm. Certain embodiments of the present invention are designed and configured for use in the treatment of females with reduced (i) sexual arousal, (ii) lubrication, (iii) libido, and/(iv) or ability to orgasm.

Certain embodiments of the present invention are designed and configured as wearable devices designed to enhance sexual satisfaction. Certain embodiments of the present invention are designed and configured for use as conditioning products to prepare a user for sexual activity. Specific embodiments can be: used to help women prepare their bodies prior to sexual activity, typically 5-30 minutes prior to intercourse; worn during sexual activity with a partner, including during intercourse; used by women alone for recreational orgasm; as A regimen, usually used for a few minutes a day, to help promote a more intense and pleasurable sexual experience during intercourse with or without a partner; or used chronically to help exercise the body for a more natural sexual response.

Device 200 is placed on the clitoris by a woman, a sexual partner, or a physician (FIGS. 32A-32B). While the product can be removed quickly and easily (if desired), gentle suction keeps the product in place (so, once in place, the product is completely hands-free). A woman is able to sit, stand up and walk around while wearing device 200 . As shown in Figure 32C, the compact remote control 1550 or smartphone app is used to adjust the vibration intensity and unique stroking pattern of the device (eg, counterclockwise movement as shown in Figures 32D-32E). 32D-32E). The sequence can be customized in advance and "playlists" can be created. Once in place, the device 200 provides noiseless, hands-free sexual stimulation of the clitoral region, working with the female body to help enhance sexual response. Certain embodiments are small (approximately 1.5 feet long and 1 foot wide), silent, waterproof, and concealed. This product is latex-free, hypoallergenic and cleans with soap and water. The product is quick and easy to put on the body and easy to remove. Can be worn under clothing without anyone knowing the user is wearing the product. Because it is a hands-free product, users can wear the device for a few minutes each day to move around, stand or walk while doing other things that help keep a woman's body at a high level of sexual response.

44A-44C illustrate a user interface for the smart remote control 1550 . These user interfaces provide means for controlling vibration and suction modes including: preloaded modes, user configured modes or combinations thereof. FIG. 44A illustrates that the user interface includes a vibration on/off button 1551 , a vibration mode selector 1552 , a vibration intensity selector 1553 and a vibration cycle speed selector 1554 . In addition to the sliders, the vibration intensity selector 1552 and the vibration cycle speed selector 1554 are both shown with numeric indicators. The vibration pattern selector 1552 can be loaded with preloaded patterns, or it can be used to store user configured patterns. The user interface provides an intuitive, easy-to-operate device to control the device's vibration and suction modes.

44B and 44C illustrate a user interface including a suction on/off button 1556 , a suction level selector 1557 , and a suction alternate speed selector 1558 . The suction on/off button 1556 also includes an "alternate" section setting. Figure 44B illustrates that when the suction on/off button 1556 is in the "on" or "off" position, the suction level selector 1557 has a single slider point and the suction alternate speed selector 1558 is difficult to use. When the user sets the suction on/off button 1556 to "on", the suction level selector 1557 can be used to set the suction level on the device, which can be displayed in single digits such as "Hg".

Figure 44C illustrates a user interface with the suction on/off button 1556 set to "alternate". In "Alternate" mode, the puff level selector 1557 has two slider points and the puff alternate speed selector 1558 is available. The "Alternate" mode enables the user to set a primary suction level with the first slider point and a higher suction level with the second slider point. The device may then alternate between these two puff levels at a particular alternate speed set by the user using the puff alternate speed selector 1558 . Thus, the user can control both the difference between the puff levels and the speed at which the device alternates between the two puff levels. Further, the user interface may include means for the user to store two puff levels and puff alternate speeds. The user interface may include preloaded puff alternation levels and speeds, user configurable puff alternation levels and speeds, or combinations thereof.

34A-34D illustrate views of a portion of a particular device with different tissue contacting configurations. In FIGS. 34A to 34D , the internal components (eg, the portion holding the vibration motor) are visible because the outer housing of the device body has been removed. Figure 34A illustrates a device with a steeper curve along the tissue contacting side of the device. In other words, the curvature of the sealing flange 225 from its proximal point to the rear section 225r of the sealing flange 225 has a greater curvature than the same sections of the other device parts illustrated in Figures 34B, 34C and 34D. Further, the sealing flange 225 of the device portion illustrated in Fig. 34A has a longer inferior section (described as inferior because it is located below the clitoris in use) or rear section 225r. This longer inferior segment (or posterior segment 225r) is configured to conform to the anatomical curvature underlying the clitoris and to facilitate interaction between the sealing flange 225 and the tissue. Both the superior and lateral flange portions are shorter relative to the longer inferior segment to enable superior positioning relative to the clitoris and reduce interaction with the labia majora. For some users, this curvature may improve the fit, comfort and reliability of the suction connection of the device. The curvature of the device illustrated in Figures 34B, 34C or 34D may be found to be desirable through other uses.

Portions of the device shown in FIGS. 34A and 34D may be formed from the molding 22 . This single molding 22 comprises a sealing flange 225 and an upper part connected to the main body of the device. Figure 40 illustrates a perspective view of the device and shows a single molding 22 joined to the device body 210 to form the device. The upper portion of the single molding 22 is located inside the device body 210 so that the vibration motor and suction port can be connected with the control mechanism inside the device body 210 .

In some embodiments of the device, a removable flange assembly is provided. The flange assembly is coupled to and removable from the device body. 35A and 35B illustrate a plan view of the device 200 with the removable flange assembly 225' attached. Figure 35B illustrates the variation in width of the flange surface 223'; in this case, the flange surface 223' is wider at the portion of the device placed beneath the clitoris. As described herein, certain embodiments of the present invention include removable flange assemblies that can have a wide variety of geometries, curvatures, and configurations.

Figure 36 illustrates a perspective view of the removable flange assembly 225' disassembled from the device body. Figure 36 illustrates the removable flange assembly connection 229' integrally formed with the removable flange assembly 225'. The removable flange assembly connection 229' is coupled to the device body and provides a substantially airtight seal to the suction chamber to enable operation of the device. Removal of flange components enables user customization. In other words, the user can choose from many removable flange assemblies in various sizes, configurations, materials, coatings and/or textures, and combinations thereof.

For example, the width of the sealing flange 223' of the removable flange assembly 225' can vary from a narrower width to a wider width. As another example, the curvature of the sealing flange can vary from a steeper curvature to a shallower curvature. Further, the sealing flange on a single removable flange assembly may have the combined width and curvature of the sealing flange. In yet another example, the removable flange assembly may be composed of a combination of materials or a single material with different properties. For example, the sealing flange can be softer and more bendable (eg, 0030A durometer silicone), while the removable flange body can be harder (eg, 20A durometer silicone). A stiffer removable flange body may facilitate connecting the non-removable flange to the device body. In yet another example, the sealing flange of the removable flange assembly can have various textures or coatings (eg, smooth or pre-coated) that potentially improve the comfort, fit, and reliability of the seal between the device and tissue. lubricated coating).

For example, Figures 43A-43G illustrate various embodiments of a sealing flange assembly 225'. 43A-43G illustrate a flange assembly 225' made from a combination of materials. The sealing flange 225 is a softer and more flexible material, while the flange body 228, which is connected to the device body, is stiffer. The sealing flange portion is molded together with the flange body portion. In the embodiment of FIG. 43A, the sealing lip 226 has sharper corners so that when tissue is drawn into the suction lumen, the sealing lip 226 forms a sharp turn relative to the sealing surface 223' to form a seal at the sealing lip.

For certain anatomy types and geometries, additional components assist in forming a seal at the sealing lip or along the sealing surface. In the embodiment of FIG. 43B, because the sealing lip 226 has additional ribs, the sealing lip 226 forms a sharp turn relative to the sealing surface 223' as tissue is drawn into the suction chamber, which then swells as the tissue engorges. Additional ribs extend beyond the sealing lip to form an airtight seal with tissue and mechanically interlock to prevent displacement of the device during use.

In the embodiment of FIG. 43C, the sealing surface 223' has a protrusion 223 all the way around the sealing surface 223' and a depression 235 all the way around the sealing surface 223'. Protrusion 233 is very soft and bendable so as to form a snug fit with any hair or small discrepancy in the fold of tissue, which can move back and forth over sealing surface 223' to prevent loss of suction along with that hair or tissue. The recesses 235 provide space for the hair or tissue and also provide a location for excess lubricant to fill around or on the hair or tissue. In the embodiment of FIG. 43D, the protrusions 233 and the indentations 235 are combined with the additional ribs of the sealing edge 226 of the embodiment shown in FIG. 43B.

The embodiment of Figures 43E-43G has two protrusions 233' and 233'' all the way around the sealing surface 223' and one protrusion 233''' that only partially surrounds the sealing surface 223'. The protrusion 233'" is located at the wider flange portion of the sealing flange 225, which is the portion of the flange below the clitoris that contacts the vulva tissue. The protrusion 233'" connects with the protrusion 233'' to form a Continuously sealed. The protrusions 233', 233'' and 233''' are all very soft and bendable so as to form a snug fit to any hair or small difference in the folds of tissue. When an adequate seal is not maintained along the sealing lip 226, the double and triple configurations provide multiple opportunities to form and maintain a seal along the sealing surface 223'.

As shown in the bottom view of FIG. 43F and the top view of FIG. 43G , in each embodiment of FIGS. 43A-43G , there are a plurality of suction holes 237 in the flange membrane 227'. Some of these holes 237 are placed on the periphery of the suction chamber to facilitate a higher seal at the sealing lip and sealing surfaces. The stimulator is integrally formed with the suction chamber membrane 220 (not shown in FIGS. 43A-43G ). The membrane pocket 239 in the flange membrane 227' matches and will accommodate the stimulator in the suction lumen membrane 220. Both the flange membrane 227' and the membrane pocket 239 are thin to maximize the energy transfer from the stimulator to the tissue through the membrane.

In certain embodiments, the sealing lip has a corrugated texture that provides additional material to conform to variations in the tissue surface. The period and amplitude of the corrugations on the sealing surface will vary with the material selected as the sealing surface, thereby contributing to a safe and leak-proof seal. In general, sealing flanges should be as thin as possible while still maintaining sufficient durability.

In certain embodiments, the lower portion of the sealing lip may be configured with seams, lines or weaknesses, thinned sections, or other features that induce pinching motion at the tissue interface. Gentle pinching of soft tissue closes the leak path in the area where the lower segment of the sealing flange interacts with the labia minora. 43H , 43I , 43J and 43K illustrate the sealing protrusion 221 on the sealing flange 225 . Sealing projections 221 provide the labia with a sealing surface. More than one sealing protrusion 221 may be used, and these sealing protrusions 221 may be located at other locations on the sealing flange 225 . The sealing protrusion 221 may include a suction port connected to the suction system of the device to facilitate tissue sealing with the protrusion. 43I , 43J and 43K illustrate different cross-sections of the sealing protrusion 221 .

Without being limited to a particular mechanism or mode of action, flanges and flange assemblies of particular embodiments can provide one or more of the following beneficial properties: (i) enable smoothing of the vaginal tissue; (ii) distributes engagement forces between the device and vaginal tissue; (iii) provides a physical component that fits under the labia majora; and/or (iv) increases the distance from the suction chamber to the external environment leak path. Each benefit contributes to a secure, comfortable and custom anatomical fit.

In certain embodiments, the outer edge portion 223e of the suction lumen 220 and/or the inner portion of the sealing flange 223' (e.g., the sealing lip 226) is the primary portion of the device that forms a seal with tissue. In other words, until the seal between the outer edge portion 220e of the suction lumen and/or the sealing edge/interior of the sealing flange 223' is substantially broken, the device can still maintain an adequate seal with tissue. In these embodiments, the sealing flange provides the beneficial attributes described above to enhance the seal and provide a secure, comfortable and custom anatomical fit. This is true for units with integral flange and sealing lip as well as units with removable flange assemblies.

37A and 37B illustrate a removable flange assembly 225' including a flange membrane 227'. The stimulator is integrally formed in the suction chamber film 220, which is kept connected with the device housing. The flange membrane 227' may be formed of the same or a different material as the flange surface 223'. The flange film 227' can be stretched relatively tightly over the central opening of the removable flange assembly 225', or it can be relatively loose and untensioned. The flange membrane 227' can be domed, flat or formed into a shape consistent with the geometry of the device. The flange membrane 227' can be stretchable or flexible or relatively inflexible. The flange membrane 227' includes one or more perforations or apertures. The flange membrane 227' may be formed during formation of the removable flange assembly 225'. For example, in some embodiments, removable flange assembly 225' is a molded part, and flange membrane 227' may act as a relatively thin section that spans beneath removable flange assembly 225' Integral with removable flange assembly 225'. The flange membrane 227' can be molded with small holes or perforations formed during molding, or these small holes or perforations can also be formed after molding. The holes or perforations in the film may be integral to the film manufacture (in other words, the film stock material already has the holes or perforations). In certain embodiments, the flange membrane may be placed in a removable flange assembly that is molded or overmolded at the appropriate position or by insert molding. In some embodiments, the flange membrane can be fixed in place after the remainder of the removable flange assembly is formed. The flange film can be adhered in place using suitable techniques, such as gluing, heat bonding, etc. The flange membrane can be any fabric or sheet suitable for contacting tissue.

Flange membranes impart several beneficial attributes to removable flange assemblies. For example, the perforations in the flange membrane are just sized to allow airflow through the membrane while reducing the likelihood of tissue being drawn into the membrane perforations or tissue being drawn into the suction port of the device. The presence of the flange membrane makes the opening of the motor membrane larger, facilitating the cleaning of the unit. In another example, the flange membrane can be further user-customizable by providing various textures that interact with the tissue. Further, the flange membrane can have various perforation sizes and/or patterns in coordination with the suction mechanism of the device, which can enhance or reduce the suction applied to the tissue.

Figure 38A illustrates a side view of the removable flange assembly 225', and Figures 38B and 38C illustrate a side view and a perspective view, respectively, of a cross-sectional view of the removable flange assembly. In these figures, the removable flange assembly connection 229' is shown as a grooved area. In this embodiment, the groove area is coupled to the outer edge of the suction chamber of the device body. In other embodiments, the removable flange assembly connection may be a protrusion that fits into a slot on the body of the device. Other configurations of the removable flange assembly connection may also be used, as long as these configurations provide an adequate airtight seal with the suction chamber.

The advantage of the removable flange assembly is that it improves the convenience and reliability of cleaning the whole unit. In certain embodiments, the removable flange assembly is made of a material that enables the removable flange assembly to be cleaned in a dishwasher while the remainder of the device body can be easily rinsed or otherwise hand washed. In this embodiment, the tissue contacting portion of the device can be cleaned more thoroughly than if the flange assembly were non-removable. Alternatively, the removable flange assembly may be used alone and may be disposable. The unit may be packaged with multiple removable flange assemblies, which may be identical to each other or have different components. Further, the user can also purchase more removable flange assemblies to be used together with the originally purchased device main body.

Another benefit of the flange film is the increased ease and reliability of cleaning the device body. In embodiments without a flanged membrane, the flexible membrane of the suction lumen includes orifices configured and sized to reduce the possibility of tissue aspiration and injury. In other words, these orifices are smaller and/or offset from the tissue. These smaller and/or offset orifices present greater challenges to reliable and thorough cleaning than larger or non-offset orifices. Further, as shown in FIG. 39 , the orifice 220h may be located on the periphery of the suction lumen 220 . The location of the orifice 220h improves drainage of fluid from the body of the device after use or after cleaning when the device is placed on a surface (with the edge of the suction chamber facing down). Typically, there is at least one hole in the top center of the flange membrane to facilitate engagement of the tissue with the stimulator.

Referring again to FIG. 40 , the device body 210 is illustrated to provide a view of the interior of the device body 21 . Vibration motor 280 is positioned within the single molding 22 structure so that stimulation from the motor can be effectively delivered to the tissue, and part of vibration motor 280 can also be connected to controller block 215 . In this case, the controller block 215 is illustrated as a printed circuit board. An on-board pump 135 is also located in the device body 210 . An onboard pump 135 is in fluid communication with the suction chamber to generate suction in the suction chamber, which is also in fluid communication with the exhaust port. The exhaust port is the outlet for air or fluid pumped from the suction chamber and the inlet for air sent to the suction chamber when suction decreases. In certain embodiments, the on-board pump 135 passes the air pumped from the suction chamber through heat-generating elements in the device body 210 before reaching the exhaust port. This airflow helps dissipate heat and provides safe and reliable use of the device.

In some embodiments, heating in the device can be monitored using components such as thermistors. The thermistor may be located in the device body 210 or integrally formed with the controller block 215 . When the thermistor detects a threshold temperature, it shuts off power to the device and/or vents outside air to the device to help the device cool down and then releases the pump.

In certain embodiments, the on-board pump is controlled by the controller block via a closed feedback loop. In other words, the controller block is configured to maintain a target pressure, which may be set by the user or may be loaded as part of a pre-programmed suction algorithm. To do this, the controller block reads real-time data from an on-board pressure sensor configured to monitor the pressure (negative pressure in the suction state) in the suction chamber. Based on this real-time data, the controller block may engage the on-board pump to generate greater suction in the suction chamber, or may engage a check valve fluidly connected to the exhaust port to vent air into the suction chamber. In normal operation, after the device has generated sufficient suction to seal it in place on the user, the controller block periodically engages the on-board pump as suction is slowly lost to leaks.

41A and 41B illustrate views of the device 200 including the device body 210 . The sealing flange 225 is coupled with the device body 210 . The curvature of the sealing flange 225 provides a comfortable and secure fit to the anatomy. Further, the front portion 225f of the sealing flange 225 has a narrower profile than the rear portion 225r of the sealing flange. This configuration allows the device body 210 to span the user's pubic bone when the sealing flange 225 is in contact with tissue. The rear section 225r of the sealing flange 225 is relatively extended to provide a wider sealing surface, similar to that shown in Figure 35B. The relatively narrow front section 225f of the sealing flange 225 is configured to fit comfortably and securely over the top of the labia majora.

41A and 41B also illustrate a device body 210 that is configured to comfortably and securely fit a user in a variety of environments. Specifically, as seen in FIG. 41A , the rear portion 21 Or of the device body 210 tapers toward the sealing edge 225 of the device 200 . This taper can help keep the partner in touch during intercourse. Devices without such a taper may hinder such access. Further, the rear portion 21 Or tapers toward a point opposite the side of the device 200 as seen in FIG. 41B . This taper can help enable the user to stand and walk during use of the device. In devices without such a taper, when some users stand or walk, the device may disengage due to contact with the user's thigh. Still further, the mechanism, controller block, battery and other internal components may be positioned toward the front of the device body 210 . Positioning the internal components in this manner enables the center of mass of the device to be placed in a manner that reduces the tendency of the device to drop or become dislodged from a user. In other words, having the center of mass of the device away from the user side of the device, or in some cases towards the rear 210r of the device body 210, allows the device to be leveraged and "pripped open" when the user is standing or even when the user is lying down. It separates the user.

FIG. 42 illustrates a perspective view of a device 2400 comprising a device body 2410 , a sealing flange 2425 and an onboard hand pump 2435 . An on-board hand pump 2435 is in fluid communication with the suction chamber of the device. The onboard hand pump 2435 is shown as a bellows style pump where the user pushes down on the outer surface to expel air from the pump chamber through the exhaust port. The pump chamber is in fluid communication with the suction chamber via one or more valves that enable suction to be drawn into the chamber when air is expelled from the pump chamber but prevent air from entering the pump chamber. Other hand pumps may also be used, such as a bulb system (similar to a blood pressure cuff) or a plunger system. The on-board hand pump can be locked in low profile when not activated.

Certain embodiments of the present invention include devices and methods for enhancing female sexual health and female sexual pleasure as well as some methods for treating symptoms of female sexual dysfunction. Particular embodiments of the invention include devices and methods for treating (i) female sexual arousal disorder, (i) hyposexual dysfunction, and/or (iii) female orgasmic disorder. The method naturally enhances a woman's own sexual response without unwanted, ongoing side effects. Women will once again enjoy sexual intimacy and feel confident in their body's ability to respond to sexual stimulation.

In the embodiments described herein, the coin vibrating motor can be positioned sideways on the tissue, disposed flat on the tissue, or at an angle with respect to the tissue therebetween. The angle relative to the tissue provides varying degrees of strength. In some embodiments, the device is configured to allow the user to directly (eg, manually) or indirectly adjust the angle of the motor by selecting a particular stimulation mode from the controller.

FIG. 45A exemplarily illustrates an embodiment in which the main body vibration source 211 (eg, a vibration motor) on the device main body 210 provides vibration stimulation at a reference level. The vibrations on the device body 210 may be the result of contacting the device body 210 with a conventional vibrator, as described in more detail below. Optionally, a body vibration source 211 may be placed on the device body 210 in addition to any stimulation elements described herein to deliver stimulation to the vaginal tissue inside the tissue cavity (or suction cavity). Advantageously, the main body vibration source 211 provides a stimulation level that helps effectively enhance the stimulation provided in the tissue cavity. In other words, the vibration at the base level can facilitate the process of engorgement and arousal, and the stimulation element integrally formed with the tissue cavity further promotes the process of engorgement and arousal. Further, the internal vibration motor can be used first to achieve sexual arousal, and then the main body vibration source can be used as additional vibration for extra pleasure and/or orgasm. Still further, the reference vibration from the main body vibration source 211 together with the vibration motor generates resonance and/or a harmonic vibration mode with the tissue. Certain users may prefer labial stimulation combined with clitoral stimulation, the main body vibration source 211 may provide vibratory labial stimulation.

In a related embodiment illustrated in FIG. 45B , multiple body vibration sources 211 a and 211 b may be positioned on the device body 210 . When multiple motors are positioned on the device body 210, the multiple body vibration sources 211a and 211b may be configured to vibrate at different frequencies, thereby creating a variety of vibration profiles. The vibration profiles can be in-phase, out-of-phase, biphasic (creating biphasic amplification), or multi-phase.

Figure 46 illustrates an embodiment of the device and method wherein one or more stimulation sources (e.g., vibration motors) 180a, 180b, 180c, and 180d are contained in a stimulation chamber 182 positioned within the device such that Can come into contact with vaginal tissues, especially the clitoris. Stimulation sources 180 a , 180 b , 180 c , and 180 d freely stimulate and/or vibrate in stimulation chamber 182 and in this way periodically apply vibration stimulation to bottom surface 183 of stimulation chamber 182 connected to suction chamber 120 . Stimulation sources 180 a , 180 b , 180 c and 180 d may be connected to the controller block by wires or may move freely within stimulation chamber 182 . In some embodiments, the control signal is a wireless signal. Further, the motor can be powered and/or charged by an RF signal, thereby freeing it from wires. In this case, the stimulus sources 180a, 180b, 180c and 180d are completely free to move within the vibration chamber. One of the features of these embodiments is that the stimulus sources 180a, 180b, 180c, and 18Od are not suspended within the suction chamber 120, but impinge on the suction chamber 120 periodically.

Figures 47A, 47B and 47C illustrate embodiments in which stimulation member 485 may be caused to impinge on a tissue cavity. 47A-47C operate in a manner similar to the embodiment described with respect to FIG. 10 . For example, an array of stimulation elements 485 can be positioned over a tissue cavity that can be rotated or otherwise moved relative to the tissue. In certain embodiments, as shown in Figure 47C, another displacement element 486 can be positioned over the array of stimulation elements 485, movement of the displacement element 486 forces a single stimulation element 485 or group of stimulation elements 485 in the array to strike the tissue cavity. The displacement element 486 and the stimulation part 485 may be permanent magnets or electromagnets, so that the displacement element 486 generates movement in the stimulation part 485 by magnetic field opposition. In embodiments where the stimulation member 485 is a permanent magnet or an electromagnet, the stimulation member 485 may be positioned on a tray or embedded in a film to maintain spacing between elements. Without such a tray or film, the magnetic attraction between the stimulation elements 485 could cause the stimulation elements to stick together and prevent the desired movement. FIG. 47D illustrates an embodiment in which an array of displacement elements is positioned above an array of stimulation components 485 . The arrangement of displacement elements 486 can be selectively addressed to create a stimulation pattern by forcing stimulation member 485 to impact tissue cavity 220 .

In many of the embodiments described herein, it is advantageous to minimize the number of moving parts. It is also advantageous to minimize the number of more expensive components. Embodiments using arrays of stimulation elements driven in some manner by fewer motors, magnets, or other energy sources achieve the advantages of fewer moving parts and/or fewer expensive parts.

In another embodiment illustrated in FIGS. 48A , 48B and 48C , the vibration source includes a vibrating stylus 3250 coupled to a motor 3220 . Stylus 3250 is positioned in translation mount 3200 that enables rapid translation of stylus 3250 to different positions relative to the tissue in the tissue cavity. In a preferred embodiment, the translation frame 3200 is configured such that the stylus 3250 returns to the center within the translation frame when the translational force is removed. For example, the stylus 3250 can be connected with the electromagnet 3340 using the elastic member 3330 . The motor housing 3220 may include permanent magnets or electromagnets that are actively translated in the translation frame by a magnetic field generated by the electromagnets. Optionally, the motor housing 3220 can be moved by a pulley system between the movable units on the translation frame. The motor connected to the stylus 3250 can be vibratingly isolated from the stylus 3250 and the translation frame 3200 by installing the motor on a damping structure such as a sponge. More than one stylus 3250 and/or more than one translation frame 3200 may be used in various embodiments described herein. In certain embodiments, stylus 3250 may be used to force stimulation member 485 in array 48 as shown in FIG. 48C to strike tissue, as further described in other embodiments herein. Figure 48A further illustrates an embodiment where the stylus 3250 translates via the interaction of a magnet 3255 positioned on the stylus arm. The electromagnets 3253 and 3257 are used to translate the stylus 3250, and the motor 3220 vibrates the stylus 3250.

In an embodiment of the apparatus and method described in FIGS. 49A and 49B , a motor 3580 positioned outside of a suction cavity 3590 is connected to or otherwise in vibratory communication with a link 3530 mounted at least partially within the suction cavity 3590 . The link 3530 directly or indirectly interacts with tissue in the suction lumen via the stimulation member 3520 . For example, the link 3530 can directly stimulate tissue by contacting the tissue, or the link 3530 can stimulate tissue indirectly by vibratingly communicating with a stimulation member (eg, array 487 shown in FIG. 48C or FIG. 49C ) in contact with the tissue. A stimulation member 3520 (eg, that shown in FIG. 49C ) can have one or more protrusions 3572 that directly stimulate tissue. The protrusions 3572 can have a variety of stiffnesses to create variable stimulation profiles. For example, some protrusions 3572 may be relatively bendable while other protrusions may be relatively rigid. Stiff protrusions transmit relatively more vibrations than bendable protrusions.

In some embodiments, the suction chamber includes an end effector coupled to and driven by a motor external to the suction chamber. As shown schematically in FIG. 50A , one or more end effectors 3630 may be selectively addressed by one or more motors 3680 . In other words, a single motor 3680 can move or vibrate one or more end effectors 3630 under the direction of the controller. Further, the controller may direct a single motor 3680 to move or vibrate only one end effector 3630 or multiple end effectors. If a single motor 3680 is directed to move or vibrate multiple end effectors 3630 , the motors 3680 may be further directed in the order in which the plurality of end effectors 3630 move or vibrate. FIG. 50B illustrates a coupler 3650 positioned between each motor 3680 and a particular end-effector 3630 to facilitate the selective transfer of motion or vibration from the motor 3680 to the desired end-effector 3630 . Couplers selectively transmit motion or vibration using a variety of methods including magnetic and mechanical coupling. For example, end effector 3630 may be coupled by selectively activating an electromagnet to introduce and connect a permanent magnet at the proximal end of end effector 3630 to coupler 3650 . Reversing the poles of the electromagnet then decouples the end effector 3630 and returns it to its original position. In another example illustrated in FIG. 50C , one of the grippers in the array of grippers 5655 can grip the proximal end of a given end effector 3630 to impart movement or vibration, and release of the gripper stops the movement or transmission of vibrations. As described in other embodiments herein, the end effector 3630 is translatable between the two dimensions shown in Figure 50D.

Advantageously, in some embodiments multiple motors may be provided in a layered arrangement with connecting rods of different lengths. This is an advantage because multiple motors can be arranged in a relatively small space and transmit vibrations to a larger vibrating member. This setup can also be combined with a stimulator (eg, a vibrating motor) suspended within the suction chamber. Alternatively, multiple motors may be layered and/or configured such that they deliver vibrations with relatively higher resolution. In other words, the motor may communicate via eg a rod with a vibrating element having a footprint that is relatively smaller than that of the motor arrangement. Further, the vibrating element can have a high density of stimulating elements which can be addressed individually or in multiples by the motor.

In contrast to some prior art devices, these embodiments interact directly with a stimulus having an array of protrusions. In other words, some prior art devices simply shake the entire array of protrusions, rather than providing a series of transfer points that effectively transfer vibrations from the motor to the individual parts of the stimulation array.

In certain embodiments, the motor or motors are located remotely from the stimulation and/or suction chamber such that the motors are contained in a separate housing. The motor may transmit the vibrations to the stimulation site via a cable or rod assembly or other similar components. The motor housing can be mounted on clothing or other wearable items. Alternatively, the motor housing can be placed near the user without the user actually wearing or holding it.

51A and 51B illustrate embodiments in which a single motor 4050 can drive a stimulus coupling element 4000 having regions of different stiffness. The rigid region of stimulus coupling element 4000 may resonate or resonate with motor 4050 . Thus, a single motor 4050 can drive spatially differentiated vibration stimuli.

Stimulus coupling element 4000 may be a mesh formed of relatively rigid nodes 4010 connected by relatively rigid spokes 4020 . The stimulus coupling element 4000 may also have a slightly less rigid region 4030 that helps isolate vibrations to the nodes. In other words, the presence of the slightly less rigid region 4030 facilitates spatial differentiation of the region that resonates or resonates with the drive motor 4050 .

Optionally, node 4010 may include a passive actuator that may be coupled to a drive motor to provide spatially differentiated stimulation. Passive actuators may include piston and cylinder configurations that store energy, such as via springs or their equivalent, and the stored energy is released and recharged via resonant coupling of node 4010 to drive motor 4050 . In certain embodiments, passive actuators at node 4010 may be selectively controlled by activating or deactivating local dampers. For example, passive actuators have selectively addressable locking mechanisms. This mechanism can be electronically controlled by a device controller block that provides spatially differentiated stimulation patterns. Microelectromechanical systems (MEMS) technology provides various approaches for locally selectively addressable control of active and passive actuators, and can be implemented in the embodiments described herein.

The devices described herein advantageously attach securely and comfortably to the user's body. In certain embodiments, the tissue cavity is configured to fit under the labia majora to make the device wearable without any other attachment mechanism (although suction is an optional attachment mechanism). In some embodiments, other components on the device provide other means of comfortably securing the device. For example, adhesives such as glue, tack, or other tacky materials may be used for tissue flanges on the device. Still further, the bendable wings 294 as shown in FIG. 52C can be detachably disposed on the device body 210 (viewed from the bottom up), and the bendable wings 294 can be configured as pressure-sensitive, heat-sensitive or moisture-sensitive surfaces. The device 200 may be provided to the user with a plurality of removable and disposable adhesive wings 294 . For many users, it is preferable to apply the adhesive to the area above the clitoris, such as the clitoral hood, where the tissue is more skin than mucous membranes.

Another method for achieving a secure, comfortable connection is to employ lateral protrusions 292 on the sides of the device 200, as shown in cross-section in Figure 52A. This lateral protrusion 292 complements the tissue flange 225 that extends below the labia majora. The lateral protrusions 292 may be resilient and bendable for ease of placement. Further, the lateral protrusions 292 may be configured to bend or snap into place after the tissue flange 225 is placed under the labia majora. Lateral protrusions 292 may be configured to transmit vibrations to the labia majora for users interested in supplemental stimulation. Optionally, the device may include soft clips to attach the device to the labia majora.

Yet another method for achieving a secure and comfortable attachment is to use a soft and relatively flexible extension 293 that attaches to the lower portion of the device 200, as shown in Figures 52B (bottom up view) and 52D (isometric view). Show. These lower extensions 293 may be configured to extend under the lip folds and compress sideways to stabilize the device 200 . The extensions 293 can be resilient and bendable so that they can be compressed together and spring back open and provide gentle support to the device during positioning of the device.

In certain embodiments, system 4100 includes intravaginal unit 4160 coupled to clitoral stimulation device 4110 . The intravaginal unit 4160 can deliver stimulation, including all types of stimulation disclosed herein. Additionally or alternatively, intravaginal unit 4160 may house any of the components of the systems disclosed herein. Optionally, the intravaginal unit 460 is passive and is used as a unit to provide additional compression/stabilization to the clitoral stimulation device 4110 . For example, in some embodiments, intravaginal unit 4160 includes a motor coupled to a stimulating element within clitoral stimulation device 4110 . The motor may be configured to provide intravaginal vibration or clitoral stimulation by transmitting vibrations through the stimulating element. Transmission elements such as cables connect the motors in the intravaginal unit 4160 to the clitoral stimulation device 4110. The intravaginal unit 4160 may be configured to engage and stimulate the erogenous zone ("G-spot") on the anterior wall of the vagina.

The coupling between the intravaginal unit 4160 and the clitoral stimulation device may be a C-shaped connector 4150 configured to provide a secure and comfortable fit. For example, the connector 4150 can be reversibly deformable, or it can be bent open or closed back to the original position. Connector 4150 may be formed from elastic or malleable wires housed within a shield. The connector has hinge points 4155 to facilitate placement. The intravaginal unit 4160 may be configured to vibrate or otherwise stimulate the G-spot via a stimulation source (eg, a motor) located near where the unit 4160 meets the connector 4150 .

In certain embodiments, the intravaginal unit is not physically connected to the clitoral stimulation device. In such embodiments, the intravaginal unit may communicate via near-field radio frequency technology or other inter-device communication methods. In such embodiments where the intravaginal unit is not physically connected to the clitoral stimulation device, the intravaginal unit may still provide additional vibratory stimulation via stimulation elements included within the intravaginal unit.

The intravaginal unit can be used to stimulate the clitoris by vibrating or resonating with a smaller device applied to the clitoris. Advantageously, this embodiment may employ a soft clip or similar device applied to the clitoris, which may be actuated to provide stimulation through the intravaginal unit. In one embodiment, the soft clip contains permanent or electromagnets that are actuatable to squeeze together and apart to provide stimulation of clitoral tissue. An intravaginal unit or a separate unit can provide an external magnetic field for actuating the soft clip.

Other embodiments of the device, shown in Figures 54A, 54B, 54C and 54D, place some or all of the stimulators below the clitoris. The body 4510 of the device 4500 in these embodiments is placed in the interlabial space such that the center of mass of the device is lower than in other embodiments described herein where a significant portion of the device is placed on the mons pubis. An advantage of this embodiment is that the weight of the device falls slightly below the clitoris, thus providing a secure and comfortable connection. The device may partially block the urethra and/or vaginal opening. The device can be configured to take advantage of its location and use any of the intravaginal unit embodiments described herein. Another advantage of this embodiment is that the stimulator 4580 can be in direct contact with the clitoris without relying on clitoral engorgement. In other words, by placing the motor under the clitoris, the motor is brought into contact with the clitoris in a relatively relaxed state. 54A, 54B, and 54C illustrate a front view, a side view, and a cross-sectional side view, respectively, of a clitoral engorgement chamber 4550.

In certain embodiments, the suction lumen is bendable and/or expandable. The suction lumen is used to make contact with clitoral and/or vulvar tissue. When suction is applied, tissue is attracted, and the flexible suction lumen is displaced and optionally expanded to further attract tissue and bring the tissue to a stimulating element such as a vibrating motor. In these embodiments, the vibration motor may be located outside the suction chamber, as opposed to being suspended from the suction chamber. Further, in addition to or instead of drawing the clitoral and/or vulvar tissue towards the stimulation element by suction, the clitoral and/or vulvar tissue may be gently squeezed towards the stimulation element. Extrusion of tissue can be accomplished using various methods. For example, the walls of the suction lumen are plastically deformable so that the user can manually manipulate the suction lumen to compress tissue. In another example, the walls of the suction lumen may be biased to squeeze together, and the user may manually separate the lumen walls when placing the suction lumen over clitoral and/or vulvar tissue.

In some embodiments, electromagnetic actuators are employed that are configured differently than conventional voice coils. For example, planar magnetic transducers may be used as actuators to deliver stimulation to clitoral and/or vulvar tissue. Planar magnetic transducers may provide direct mechanical stimulation via a diaphragm or membrane in direct contact with the tissue, or they may provide acousto-mechanical stimulation of the clitoral and/or vulvar tissue driving air.

Planar magnetic transducers typically consist of a diaphragm and magnetic array with printed circuits distributed on the surface of a thin-film substrate. The magnetic array generates a magnetic field parallel to the diaphragm. Membrane sheets are highly responsive to electrical signals and can be used to generate spatially differentiated kinesthetic sensations and forces.

In other embodiments, magnets may be embedded in a membrane positioned and configured to stimulate clitoral and/or vulvar tissue. Electromagnetic arrays can be positioned on the membrane to drive specific magnets and generate spatially differentiated stimuli. In other words, selectively activating the electromagnetic array can drive a single embedded magnet or groups of embedded magnets. Alternatively, instead of an electromagnetic array, one or more removable permanent magnets may be used to selectively drive a single embedded magnet or groups of embedded magnets. The permanent magnets can be moved by various mechanical or electromechanical devices according to various programmable or pre-programmed patterns.

In certain embodiments, the system includes a vacuum tank. In other words, the system includes a chamber capable of maintaining a negative pressure applied to the suction chamber of the device through a valve system. During initial connection, after the suction chamber reaches the desired level of suction, such as with an on-board pump, the vacuum source continues to operate to provide excess negative pressure to the vacuum tank. The on-board pump can be stopped, and if there is a small leak, the negative pressure in the vacuum tank will provide suction to the suction chamber until exhausted, then the on-board pump will return to fill the vacuum tank and suction chamber before stopping. One advantage of a vacuum canister is to maintain the desired level of suction while operating the suction source relatively less compared to a system without a vacuum canister.

The systems described herein can be equipped with sensors and sensing capabilities. Data collected through sensing can be used in a variety of ways, for example, for display to a user and/or feedback to a device control system. Sensed parameters include tissue temperature, tissue impedance, blood flow, tissue swelling and/or congestion, heart rate, and blood pressure. These data can be presented on a user-controlled device, such as a smartphone. These data can be presented graphically and/or numerically, and can also be mapped onto anatomical visualizations. In a sense, the displayed data can be a "sexual arousal meter" that provides information to the user. Further, the user's state of sexual arousal can be used to provide a biofeedback loop to control the device. For example, the user can set a sexual arousal level on the device before use and the device can monitor the user's sexual arousal status. By sensing the state of sexual arousal, the device control system can increase or decrease stimulation to meet the state set by the user.

In some embodiments, an actuator is used instead of a coin or other vibrating motor. One type of actuator is a linear drive in which components are driven back and forth. An example of a linear actuator such as an electromagnetic voice coil described herein, where a membrane is driven in response to an electromagnetic voice coil. Other linear actuators include electromagnets and passive magnets arranged in a piston configuration to produce linear motion.

In certain embodiments, the linear actuators used are not driven by electromagnetic fields alone or at all. For example, a pneumatic actuator in which a tank is filled with compressed gas (including air) by a pump may be employed. The pump can be a hand pump, such as a bellows or syringe pump. A linear drive element of the pneumatic actuator is biasable in a first position and actuated to a second position by a burst of gas discharged from the gas tank through the valve system. Other arrangements of pneumatic actuators are useful in these embodiments.

In certain embodiments, other types of microactuators are used to generate stimulation forces. For example, various types of thermomechanical and thermoelectric actuators can be used to drive the stimulation elements in the device. Such actuators include those that utilize thermoelectricity to expand a fluid, and this fluid expansion can drive a mechanical element (eg, a piston). Other thermoelectric actuators useful in certain embodiments include shape memory alloys, such as Nitinol, which can be used to generate mechanical motion when heated thermoelectrically. More generally, actuators capable of producing kinesthetic force and pleasure, including the various actuators disclosed herein, are suitable for use as stimulators.

In some embodiments, a pneumatic system can be used to achieve stimulation. Pneumatic systems with microscopic orifices deliver bursts of air (or other gas) rapidly to create tactile and/or kinesthetic pleasure and power. The speed and volume of the jet of air can be varied to produce various stimuli. Multiple orifices delivering puffs of air can be used for spatially differentiated stimulation of clitoral and/or vulvar tissue. Multiple orifices can be configured using valves and orifice arrays that deliver air from one or more pneumatic sources. Alternatively, an array of pneumatic sources may be employed.

In some embodiments, circulating air may be used to provide stimulation. As with pulsed air or blasted air, one or more pneumatic sources may deliver air through a system of valves and orifices. In contrast to pulsed air systems, circulating air systems can be used to stimulate tissue by blowing air into the tissue rather than pulsing it. Certain embodiments employ two types of pneumatic systems for circulating and pulsed air. Further, pulsed air may also be directed across the tissue surface. Also, the pneumatic stimulator may be used with any of the types of other stimulators described herein.

Referring to systems including a variety of valves and orifices, in certain embodiments, a suction source is used to deliver suction through an array of valves and orifices. Such a system may engage clitoral and/or vulvar tissue at multiple spatially differentiated locations. Alternatively, multiple individually controlled suction sources may be used in conjunction with or instead of the valve and orifice array. In some embodiments, rapid puff strokes may be used to generate kinesthetic pleasure and power.

In many of the embodiments described herein, it is desirable to apply therapeutic energy, such as light energy or electromagnetic energy, to clitoral and/or vulvar tissue. Specific light frequencies can reduce tissue inflammation, and specific light frequencies can increase local blood flow.

In many of the embodiments described herein, it is desirable to provide ambient sound via a device or system. Ambient sound may be a sound space that promotes a user's emotional feelings and/or sexual arousal. Additionally, the ambient sound may be "white noise" that provides a relatively constant background sound, thereby masking or reducing sounds produced by the device during operation. To this end, the device or system may include an active noise cancellation system.

While the invention has been described with reference to specific embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiment disclosed as the best mode contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope of the appended claims.

Claims (20)

1. A device for promoting sexual arousal in a female user, comprising: a tissue contacting chamber comprising a suction chamber; and at least two motorized stimulator. 2. The apparatus of claim 1, further comprising a suction tuning element, wherein the suction tuning element is in fluid communication with the tissue contacting lumen. 3. The device of claim 1, wherein parameters of the electromechanical stimulator are controlled and selected from the group consisting of vibration frequency, vibration intensity, vibration duration, motor vibration sequence, and combinations thereof. 4. The device of claim 3, wherein the electromechanical stimulator is controlled by selecting a pre-programmed algorithm, a user-defined algorithm, or a combination thereof. 5. The device of claim 1 , comprising a wearable device body having an attachment area adapted to fit the female user between the labia majora below the clitoris and away from the labia majora above the clitoris. The shell of the labia, the length of the junction area and the height of the shell allow for sexual intercourse. 6. The apparatus of claim 5, comprising three stimulators forming clitoral tissue cavities in a triangularly spaced relationship. 7. The device of claim 1, wherein the electromechanical stimulator is a miniature coin-type motor. 8. The apparatus of claim 7, wherein the miniature coin motor is encapsulated in a convex film. 9. The apparatus of claim 1, further comprising a suction generating device and a wearable device body, wherein the suction generating device is detachable from the wearable device body. 10. The apparatus of claim 9, wherein the electromechanical stimulator remains in substantial contact with tissue after the suction generating device is detached. 11. The device of claim 1, further comprising a membrane at least partially encapsulating at least one of the stimulators. 12. The apparatus of claim 11, wherein the membrane is coupled to the suction lumen. 13. The apparatus of claim 12, wherein the electromechanical stimulator is flexibly suspended via the membrane. 14. The device of claim 11, wherein the membrane is configured to be replaceable by a user's clitoris. 15. The device of claim 1, wherein the stimulator is controlled such that a user experiences simulated macroscopic motion. 16. The apparatus of claim 1, wherein vibrations generated by a stimulator are isolated from walls of the tissue contacting chamber. 17. A device for promoting sexual arousal in a female user, comprising: a tissue contacting chamber comprising a suction chamber fluidly connected to a programmable suction pump; and a pump mounted on the suction chamber At least two motors inside; wherein, the motor and the suction pump are configured to be independently controllable via a control circuit. 18. The apparatus of claim 17, further comprising a controller block, wherein the controller block includes a preload vibration pattern and a preload suction pattern. 19. The device of claim 18, wherein the controller block is configured to enable a user to create a vibration pattern or a suction pattern. 20. The apparatus of claim 17, wherein the apparatus comprises a wearable device body and the programmable suction pump is mounted within the device body.