SE537386C2 - Apparatus for promoting female sexual well-being - Google Patents

Abstract

ABSTRACT OF THE DISCLOSURE Devices, systems, and methods for promoting female sexual Wellness andfunction. The devices, systems, and methods encourage clitoral engorgement using suction over the clitoris combined With vibratory stimulation. _65-

Description

[01] Embodiments of the present invention relate generally to devices and methods andmore particularly to promoting female sexual Wellness and function. In particular, certainembodiments are useful for promoting, facilitating, stimulating, or enhancing sexual desire, arousal or satisfaction in a female.

BACKGROUND OF THE INVENTION

[02] Clitoral vascular engorgement plays an important role in female sexual desire,arousal and satisfaction. Sexual arousal results in smooth muscle relaxation and arterialvasodilation Within the clitoris. The resultant increase in blood flow leads to tumescenceof the glans clitoris and increased sexual arousal. A variety of conditions may causeclitoral erectile insufficiency and reduced clitoral arterial floW. This, in tum, may lead todifficulty or inability to achieve clitoral tumescence. Female sexual Wellness may also benegatively affected by a lack of subjective excitement, genital lubrication or orgasmic function.

[03] The incidence of symptoms ranging from dissatisfaction to dysfianction is high inWomen. For example, in the National Health and Social Life Survey of 1,749 Women age18-59, 43% experienced sexual. Further, female sexual dysfunction is altered With aging,is progressive and highly prevalent affecting 30-50 % of Women and 68 to 75% of Womenexperience sexual dissatisfaction or “problems” (not dysfunctional in nature). In anational survey of more than 31,000 Women in the United States, 44.2 % of Womenreported experiencing a sexual problem. According to other studies, over 53 millionWomen (43% of the U.S. population) have reported one or more sexual problems andover 14 million Women meet the clinical criteria for Female Sexual Dysfunction (FSD),With loW desire being by far the most common problem (reported by 46 million Women).(See, e.g., Spector I, Carey M. Incidence and prevalence of the sexual dysfunctions: acritical review of the empirical literature. 19: 389-408, 1990; Rosen RC, Taylor JF,Leiblum SR, et al: Prevalence of sexual dysfunction in Women: results of a survey studyof 329 Women in an outpatient gynecological clinic. J. Sex. Mar. Ther. 19:171-188, 1993; Read S, King M, Watson J: Sexual dysfunction in primary medical care: prevalence, Characteristics and detection by the general practitioner. J. Public Health Med. 19:387-391, 1997; Laumann E, Paik A, Rosen R. Sexual Dysfunction in the United StatesPrevalance and Predictors. JAMA, 1, 281: 537-544; Read S, King M, Watson J. Sexualdysfunction in primary medical care: prevalence, characteristics and detection by thegeneral practitioner. J Public Health Med. 1997;19:387-91; Schein M, Zyzanski SJ,Levine S, Medalie JH, Dickman RL, Alemagno SA. The frequency of sexual problemsamong family practice patients. Fam Pract Res J. 1988;7: 122-34; Shifren JL, Monz BU,Russo PA, Segreti A, Johannes CB. Sexual problems and distress in United StatesWomen: prevalence and correlates. Obstet Gynecol. 2008;112(5):970-978; and Shifren,Obstet Gynecol 2008; 112: 970-8. Each of these publications is incorporated by reference herein.)

[04] Research indicates that a sufficient blood supply is required for good clitoral andvaginal function and satisfying sexual experience at any age. Women at risk for FemaleSexual Dysfunction include those using birth control pills, those With poor vascular health(such as those With diabetes, high cholesterol, or hypertension), aging Women and thoseundergoing or having undergone cancer radiation treatment (Which may adverselydecrease lubrication, hormone levels, and/or genital sensation). Using birth control pillscan lower the circulating levels of testosterone needed to regulate blood flow to genitalsand stimulate sexual desire and can cause long-terrn permanent sex hormoneinsufficiency. Also, the prevalence of sexual problems increases dramatically by age,With 27.2% of Women aged 18 to 44 years, 44.6% of Women aged 45 to 64 years, and 80.1% of Women aged 65 years and older reporting sexual problems.

[05] While the majority of male and female sexual organ is similar, a subtle anatomicaldifference makes females more susceptible to inhibitors. While the glans penis in menand the glans clitoris in Women similarly each have the highest concentration of sensoryreceptors than any other location in the body, the male anatomy provides more extensivestructural support for the glans penis. Addressing male sexual dysfunction can takeadvantage of this structural support by augmenting or enhancing the venous trappingfunction of the corpus cavemosum. In contrast, no anatomical sustain mechanism existsin Women for engorgement making Women more susceptible to an array of powerful inhibitors. While the female corpus canvemosum does become engorged during stimulation (see Figure 29), it does not sustain engorgement to the same degree as the male anatomy.

[06] Figure 30 illustrates the variety of factors that can act as inhibitors or promoters ofsuff1cient sexual stimulation. For example, Figure 30 illustrates how sensory andpsychosocial factors, such as the well-being of the woman”s relationship with her partnerand emotional or visual cues, drive central nervous system (CNS) mediated promotion orinhibition (denoted by the +/- symbol). Other health factors such as diabetes orcardiovascular disease or factors such as drugs can drive other inhibition or promotion.This multifactorial web has made developing a safe drug for treating women very challenging.

[07] The female sexual response cycle affects the incidence of a satisfying sexualexperience (SSE) for women. The cycle includes the states of (i) emotional and physicalsatisfaction, leading to (ii) emotional intimacy, leading to (iii) being receptive to sexualstimuli, leading to (iv) sexual arousal, leading to (v) arousal and sexual desire, whichtakes the cycle back around to the state of (i) emotional and physical satisfaction.Spontaneous sex drive can occur between states (ii) and (iii), between states (iii) and (iv), and/or between states (iv) and (v).

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

BRIEF SUMMARY OF THE INVENTION

[09] Certain embodiments of the present invention are related to a system or a methodfor promoting female sexual arousal; for clitoral engorgement using suction combinedwith vibratory stimulation; for providing variable and customizable control of vibrationand suction; for providing a novel power-tissue optimization scheme based on stimulatorsmounted on a flexible membrane; for providing a novel suction attachment modalitycombined with multi-focal actuators; and for providing novel actuators for mechanical motion and suction. [l0] Certain embodiments of the present invention are related to a system, or a methodfor providing a tissue-contacting chamber and at least two stimulators coupled to the chamber and controlled such that the user experiences spatially differentiated stimulation.

The system can include a Suction port in fluid communication With an interior of thetissue-contacting chamber. The system can include a suction adjustment mechanismintegral to the tissue-contacting chamber. The system can include a plunger positionedWithin the interior of the tissue-contacting chamber and configured to adjust suctionWithin the tissue-contacting chamber. The system can include a sealing surface attachedto the tissue-contacting chamber and conf1gured to maintain a substantially airtight sealagainst tissue. The system can include a controller and/or remote controller. The systemcan include that parameters of the stimulators are controlled and the parameters areselected from the group consisting of vibrational frequency, vibrational intensity,vibrational duration, sequence of motor vibration, and combinations thereof The systemcan include that the stimulators are controlled by selecting from a pre-programmedalgorithm, a user-customizable algorithm, or combinations thereof The system caninclude a suction-generating device and a Wearable device body, Wherein the suction-generating device is detachable from the Wearable device body. The system can includethat the device body remains substantially in contact With tissue after the suction-generating device is detached. The system can include a membrane at least partiallyencapsulating at least one of the stimulators. The system can include that the membrane iscoupled to the chamber. The system can include that the membrane is configured to bedisplaceable by the user°s clitoris. The system can include that the stimulators arecontrolled such that the user experiences simulated macroscopic motion. The system caninclude that the stimulators generate macroscopic motion While contacting tissue. Thesystem can include that vibration generated by one stimulator is isolated from vibrationcreated by another stimulator. The system can include that vibration generated by onestimulator is isolated from a Wall of the tissue-contacting chamber. The system caninclude that at least one of the stimulators are held in direct contact With the user°s clitoris during an application of suction. [ll] Certain embodiments of the present invention are related to a system, or a methodfor providing a mechanically-stabilized housing, a suction chamber Within the housing,and a plurality of stimulators. The system can include a low-profile housing. The systemcan include that the housing is configured to be Wearable. The system can include that thestimulators are configured to provide multivariate stimulation. The system can include that the stimulators are configured to provide a combination of macroscopic motion and _4_ vibratory stimulation. The system can include that the stimulators are configured to generate a stroking motion.

[12] Certain embodiments of the present invention are related to a system, or a methodfor providing a tissue-contacting chamber including a suction chamber, the suctionchamber being in fluid connection with a programmable suction pump, and at least twostimulators mounted within the suction chamber, wherein the motors and the suctionpump are configured to be independently controllable via a control circuit. The systemcan include a controller block that includes pre-loaded vibration pattems and pre-loadedsuction pattems. The system can include that the controller block is conf1gured to allow auser to create vibration pattems and suction pattems. The system can include a wearabledevice body and a suction pump is mounted within the device body. The system caninclude that the controller block is configured to enable the user to set a first suction leveland a second suction level. The system can include that the controller block is configuredto enable the user to set a rate at which the suction pump altemates between the first suction level and the second suction level.

BRIEF DESCRIPTION OF THE DRAWINGS

[13] Figures 1A through 1D illustrate various views of a device according to an embodiment of the invention.

[14] Figures 2A through 2D illustrate various views of the interior components of a device according to an embodiment of the invention.[15] Figure 3A illustrates a membrane according to an embodiment of the invention.

[16] Figure 3B illustrates a perspective view of the body-contacting side of a device according to an embodiment of the invention.

[17] Figure 3C illustrates a close-up perspective view of the body-contacting side of a device according to an embodiment of the invention.

[18] Figure 4A illustrates a perspective view of the interior of a chamber portion and associated stimulators of a device according to an embodiment of the invention.

[19] Figure 4B illustrates a perspective view of the exterior of a chamber portion and associated stimulators of a device according to an embodiment of the invention.

[20] Figure 5A i11ustrates a perspective view of the interior of a Chamber portion and associated stimu1ators of a device according to an embodiment of the invention.

[21] Figure 5B i11ustrates a perspective view of the exterior of a chamber portion and associated stimu1ators of a device according to an embodiment of the invention.

[22] Figure 6 i11ustrates stimu1ators and vibration iso1ators of a device according to an embodiment of the invention.

[23] Figure 7 i11ustrates a wearable garrnent and a device according to an embodiment of the invention.

[24] Figures 8A through 8C i11ustrate various views of a device according to an embodiment of the invention.

[25] Figures 8A” through 8C° i11ustrate various views of a device according to an embodiment of the invention.

[26] Figure 9 i11ustrates a portion of a device configured to provide macroscopic motion according to an embodiment of the invention.

[27] Figure 10 i11ustrates a portion of a device configured to provide macroscopic motion according to another embodiment of the invention.

[28] Figure 11 i11ustrates a device configured to provide macroscopic motion according to an embodiment of the invention.

[29] Figure 12 i11ustrates a perspective view of a device according to another embodiment of the invention.

[30] Figure 13 i11ustrates a cross-sectiona1 view of a device according to another embodiment of the invention.

[31] Figures 14A and 14B i11ustrate views of a device and assembly of such a device according to another embodiment of the invention.

[32] Figures 15A and 15B i11ustrate views of a device according to another embodiment of the invention.

[33] Figure 16 i11ustrates a view of a device according to another embodiment of the invention.

[34] Figure 17 i11ustrates a view of a device according to another embodiment of the invention.

[35] Figure 18A and 18B i11ustrate perspective views of a device and a detachab1e suction element according to another embodiment of the invention.

[36] Figure 19 i11ustrates a cross-sectiona1 view of a device according to another embodiment of the invention.

[37] Figure 20 i11ustrates a cross-sectiona1 view of a device and a perspective view of a contro11er according to another embodiment of the invention.

[38] Figures 21 and 22 i11ustrate stimu1ator and 1ever arrangements according to embodiments of the invention.

[39] Figures 23A and 23B i11ustrate a device providing macroscopic motion according to an embodiment of the invention.

[40] Figures 24A through 24D i11ustrate various views of a device according to an embodiment of the invention.

[41] Figures 25A and 25B i11ustrate a charging station and device according to an embodiment of the invention.

[42] Figure 25C i11ustrates a charging station and device according to another embodiment of the invention.

[43] Figures 26A and 26B i11ustrate views of a device and a contro11er according to an embodiment of the invention.

[44] Figures 27A and 27B i11ustrate views of a device according to an embodiment of the invention.

[45] Figure 28 i11ustrates a view of a device according to an embodiment of the invention.

[46] Figure 29 i11ustrates a view of certain e1ements of the human fema1e anatomy re1evant to embodiments of the invention.

[47] Figure 30 is a flowchart i11ustrating mu1tip1e inhibitors and promoters of a satisfying sexual experience and their interdependence.

[48] Figures 31A through 31C illustrate the relationship between engorgement and vibration propagation.[49] Figures 32A through 32E illustrate use of various embodiments of the invention.[50] Figure 33 is a partial cross-sectional view of another embodiment of the invention.

[51] Figures 34A through 34D are side views of a portion of certain embodiments with different tissue contacting configurations.

[52] Figures 35A and 35B are plan views of a device with a removable flange assembly.[53] Figure 36 is a perspective view of a removable flange assembly.

[54] Figures 37A and 37B show a removable flange assembly including a flange membrane.[55] Figure 38A is a side elevation of a removable flange assembly.

[56] Figures 38B and 38C are a side elevation and a perspective view, respectively, of a cross-section of the removable flange assembly of Figure 38.[5 7] Figure 39 is a plan view of the flexible membrane of the suction chamber.[58] Figure 40 is a perspective, phantom view of an integrated device.

[59] Figures 41A and 41B illustrate a device body conf1gured to fit comfortably and reliably on a user in multiple contexts.

[60] Figure 42 is a perspective view of a device that includes an onboard manualpump.[61] Figures 43A-43K show various embodiments of the sealing flange assembly.

[62] Figures 44A-44C illustrate user interfaces for a smartphone-type controller.

[63] Figures 45A and 45B illustrate a side view and a partial interior view of a device having motors in the device body.

[64] Figure 46 illustrate a device having multiple motors free to vibrate and impinge upon a tissue chamber.

[65] Figures 47A-47D illustrate arrays of stimulating elements for use in a device. _g_

[66] Figures 48A-48C illustrate a stylus-type stimulation system and a complementary stimulating array.

[67] Figures 49A-49C illustrate a motor and end effectors systern for stimulating tissue in a tissue or suction Chamber.

[68] Figures 50A-50D illustrate arrays of end effectors in combination with at least one motor and at least one coupler for stimulating tissue.

[69] Figures 51A and 51B illustrate two views of a spatially differentiated resonating element driven by one or more motors.

[70] Figures 52A-52D illustrate various embodiments of device with stabilizing, adhering, and/or securing features.

[71] Figure 53 illustrates an embodiment of a device capable of simultaneous intravaginal and clitoral fit and stimulation.

[72] Figures 54A-54D illustrate embodiments of a clitoral engagement chamber and associated device body.

DETAILED DESCRIPTION OF THE INVENTION

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

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

[75] Short summaries of certain terms are presented in the description of the invention.Each term is further explained and exemplified throughout the description, figures, andexamples. Any interpretation of the terms in this description should take into account the full description, figures, and examples presented herein. _9_ a: aa a:a,

[76] The singular terms an,” and “the” include plural referents unless the contextclearly dictates otherwise. Thus, for example, reference to an object can include multipleobjects unless the context clearly dictates otherwise. Similarly, references to multiple objects can include a single object unless the context clearly dictates otherwise.

[77] The terms “substantially,” “substantial,” and the like refer to a considerabledegree or extent. When used in conjunction with an event or circumstance, the terms canrefer to instances in which the event or circumstance occurs precisely as well as instancesin which the event or circumstance occurs to a close approximation, such as accounting for typical tolerance levels or variability of the embodiments described herein.

[78] The term “about” refers to a value, amount, or degree that is approximate or nearthe reference value. The extent of variation from the reference value encompassed by the term “about” is that which is typical for the tolerance levels or measurement conditions.

[79] The term ““stimulator” refers to elements that provide stimulation usingmechanical motion (such as vibration), electrical stimulation, temperature, or other sensory stimulation.

[80] Certain biological mo lecules and anatomical structures exist in a healthy female tocreate engorgement of the vulvar and clitoris erectile tissues. These molecules andstructures facilitate stiffening the underlying stratum upon which the nerves in the clitorisare deployed. The effect of the stiffening is to allow for the more rigid projection andpresentation of the clitoral structures for stimulation, as well as mechanically allowingenergy waves to be propagated across the surface more efficiently with less energyabsorption by the tissues. As a result, a rigid clitoris stimulated mechanically viadeflection, vibration, and the like propagates these forces across the tensed surface of thestructure rather than being lost within the loose connective tissue. Thus, means forproducing an engorged environment (via drugs or via suction, for example) can enhancesensation and produce other reflexive responses (e.g., lubrication and oxytocin release).Further, the type and distribution of sensory nerve endings within the tissues of theclitoris and surrounding tissue explain why certain motions, pressures, vibrations, andother stimuli more optimally deliver pleasurable sensations than others. Vibration andsuction both have the capacity to stimulate engorgement via the nitrous oxide pathway and thus both can increase sensitivity to sexual stimulation. The two follow different _10- neuronal/physiologic pathways. Dual-triggering With the use of vibration and Suctioncombined provide additive effects. Pacinian or pacini corpusles also called Vater-pacinireceptors conduct signals in response to vibratory “pressure” (tissue vibration isconducted via a pressure Wave) - the reflex responses utilize NOS pathways Whichdeploy into the same structures that are engorged in the embodiments of the suctionelements described herein. Motion/slippage in a repetitive pattern also produces a“pressure” pattern and vibratory nerve signaling. Nerves can adapt to stimuli quickly,thus vibration in one spot Will typically become less impactfial, therefore moving the siteof vibration is benef1cial, Whether manually or automatically. All of the above aremediated by DH testosterone and other horrnonal components (and thus testosteronetherapy can help improve the quality of the tissues as Well as their “activity”) but We havediscovered through mechanical stimulation - either through suction or vibration or both -many of the horrnonal pathways can be bypassed and the reflex responses can be triggered directly. [8l] We have discovered that engorgement and vibration together are a poWerfulcombination such that engorgement creates a more suitable mechanical back-board forthe pacinian corpusles to be stimulated and that applying both simultaneously shouldproduce more profound effects than either applied alone. In both sexes, engorgement ofthe sexual organs is the key physiological target in that engorgement is fiandamental toachieve an SSE. As illustrated in Figures 3 lA through 3 lC, vibrational energy propagatesbetter along a tensioned, engorged substrate. Embodiments described herein provide methods and devices for engorging sexual organs to better propagate vibrational energy.

[82] Certain prior art stimulation devices, such as vibrators, provide relatively diffusestimuli. That is, the vibrating motion supplied by a vibrator is applied relatively evenlyover the clitoris and surrounding tissue. In certain vibrating devices that are capable ofdelivering vibration over a more tightly focused area, the frequency and magnitude of thevibration may still present a relatively diffuse vibratory motion to clitoral tissue.Additionally, much of the vibration of prior art vibrators is lost in vibrating the handle, housing and the user”s hand or other portion of their body.

[83] Advantageously, certain embodiments described herein are capable of providing complex pattems of suction. Such complex suction Waveforrns can provide a _11- comparatively organic stimulation experience as compared to prior art mechanicalstimulation devices. For some users, the Variable suction patterns, algorithms waveforrnsof certain embodiments can provide engorgement and stimulation such that effective arousal is achieved without the use of vibration.

[84] Advantageously, and in contrast to prior art devices, embodiments describedherein are capable of providing spatially-differentiated vibratory motion. That is, awoman experiences spatially-differentiated vibratory motion. In certain embodiments,such spatially-differentiated vibratory motion may simulate an experience of macroscopicmotion about the clitoris. Macroscopic motion can be understood as analogous to strokingmotion, lingual motion, or motion consistent with intercourse. For some users, thespatially-differentiated vibratory motion of certain embodiments can provideengorgement and stimulation such that effective arousal is achieved without the use ofsuction. For some users, the macroscopic motion about the clitoris of certainembodiments can provide engorgement and stimulation such that effective arousal is achieved without the use of suction.

[85] An aspect of spatially-differentiated stimulation is the isolation of the stimulationgenerated by a stimulator(s) from the stimulation generated by another, nearby stimulator.By isolating the stimulation generated by one motor from another, a device simulatesand/or mimics macroscopic motion about the clitoris. Another aspect of spatially-differentiated stimulation is isolation of the stimulation generated by a stimulator(s) fromthe housing which minimizes loss of stimulation and allows the stimulation to be focused on the tissue of interest.

[86] A further benefit of isolating vibration in devices according to embodimentsdisclosed herein, is that a small device may be discreetly wom which produces little noise while a focused, isolated vibration is applied and clitoral tissue is engorged.

[87] Certain embodiments of devices disclosed herein use suction to draw tissue intocontact with vibrating elements. Certain devices remain in contact with tissue by virtue ofthe suction applied to the tissue. Yet another benefit of isolating vibration in devices isthat the airtight seal between the device and tissue is not substantially disrupted by thevibration. This type of vibration isolation involves substantially isolating the sealing elements of the device from the vibrating elements in the device. _12-

[88] The compact size of devices disclosed herein makes them capable of beingdiscreetly wom and capable of being carried in a purse. Yet, devices disclosed herein aresized and conf1gured to be accessible and controllable while being wom. Devicesdisclosed herein may be usable prior to and during intercourse or as a program forrecruitment of blood flow and nerve sensitization of tissue. Devices disclosed herein maybe adjustable and customizable and provide selectable, variable suction and vibrationalproperties. Devices disclosed herein may be capable of being controlled remotely, such asby a smartphone. Devices discloses herein may be capable of promoting and/or sustaining female sexual arousal.

[89] Advantageously, devices disclosed herein use relatively low power motors to produce focused, spatially-differentiated vibration.

[90] According to certain embodiments, the device has some or all of the followingcharacteristics: (i) has a suitable fit; (ii) provides appropriate stimulation; (ii) is sufficiently comfortable or tolerable; and (iv) perforrns reliably and safely.

[91] Regarding suitable fit, the following attributes may be present in a device having asuitable fit: (i) the device is wearable while ambulatory without the need for a tether oradditional garrnent; (ii) the device is sized such that the attachment area fits between thelabia majora inferior to the clitoris and the housing may exit the labia majora superior tothe clitoris; (iii) the device continues to fit throughout the engorgement process; and (iv)the device is wearable during sexual intercourse. Further, the device can be conf1guredsuch that placement of a portion of the device posterior of the labia majora is suff1cient to securely hold the device in place, with or without additional suction.

[92] According to certain embodiments, suitable fit can be achieved by providing someor all of the following parameters: (i) the device design and center of gravity allow thedevice to hold to the tissue for at least 5 minutes without a tether; (ii) the device may bewom under clothing; (iii) the mass of the device allows for attachment by suction only;(iv) the device stay in place for at least 5 minutes without adjustment; (v) the device has acompliant tissue interface region; (vi) the device stays in place while standing andwalking while wearing the device; (vii) the footprint of device attachment area isanatomically appropriate; (viii) the device is designed to fit over at least a woman°s clitoral region; (ix) the device provides space for the tissue to expand; (x) the extemal _13- device envelope allows for discreet use; (xi) the device is designed such it does notocclude or limit access to the vaginal opening; (xii) the device body can withstand a forcecompressing it against a soft surface, such as a body; (xiii) the device height does not limit interaction of partners and the edge geometry is comfortable for both partners.

[93] In certain embodiments, proper placement can be achieved by activating one ormore motors to a detectable level of vibration to allow the user to center the stimulatoryeffect about the clitoris. By pre-activating the motors during placement, the user cancustomize the fit and deterrnine the most effective location for vibrational simulation and/or suction stimulation.

[94] Regarding appropriate stimulation, one or more of the following attributes can bepresent in a device providing appropriate stimulation: (i) the device applies suction to thevulvar region or more specif1cally the clitoral region to facilitate engorgement of theclitoral tissues; (ii) the device is capable of applying vibrational energy to at least theregion of clitoral tissues; and (iii) the device provides stimulation for a suff1cient period of time to achieve the desired degree of arousal.

[95] According to certain embodiments, appropriate stimulation may be achieved byproviding some or all of the following parameters: (i) the device provides suction to theclitoral region in a range of about 0.7 in Hg to about 9 in Hg; (ii) the device providessuction with the optional addition of personal lubricant in an environment in which pubichair is present; (iii) the device maintains the selected level of suction for a minimum of 5minutes; (iv) the user can control the level and pattem of suction including via use ofwireless remote control; (v) the device generates vibration within the frequency range of100-300 Hz; (vi) the vibrational forces (peak to peak) under load promote arousal; (vii)the vibratory elements are held in direct contact with tissue when suction is applied; (viii)the device provides full power stimulation for a minimum of 30 minutes on a singlebattery charge; and (ix) the device is capable of moving the vibration between sources as directed by the user.

[96] Regarding comfort and tolerability, one or more of the following attributes may bepresent in a device that is suff1ciently comfortable and tolerable: (i) the device allows forthe user to release suction when desired; (ii) the device does not produce excessive noise; (iii) the device does not cause irritation of the urethra; and (iv) the device is comfortable _14- to wear, with tissue contact surfaces that are soft and pliable and/or smooth with no protrusions.

[97] According to certain embodiments, sufficient comfort and tolerability may beachieved by providing some or all of the following parameters: (i) the user can release thesuction within 5 seconds when desired; (ii) the device does not produce sound thatexceeds 70 dB, as measured at a distance of 2 inches from the outside of the shell whenattached to the user; and (iii) the device fits over a woman°s vulvar or clitoral region without occluding the urethral opening.

[98] Regarding reliable and safe performance, the following attributes may be presentin a device that perforrns safely and reliably: (i) the device does not pose a hazard of electrical shock; and (ii) the device allows for proper cleaning or disposal after each use.

[99] According to certain embodiments, reliable and safe performance may beachieved by providing some or all of the following parameters: (i) the battery andelectronics compartment(s) isolated from incidental contact with fluids; (ii) the maximumdischarge rate of battery is not considered hazardous; (iii) the device life may be rated at2-3 years; (iv) the stimulators are rated for at least sufficient use; (v) the device is waterresistant when cleaned as recommended; and (vi) the device protects regions from contact with tissue / fluids or allows access to region behind the tissue interface for cleaning.

[100] Certain embodiments have some or all of the following features: (i) the user isable to customize the suction and vibratory stimulation to suit their needs; (ii) the devicewithstands stresses of normal use; and (iii) the device may not have any user-replaceable parts.

[101] Specific aspects of the device features may include some or all of the following:(i) the user is able to set suction to the level that is comfortable to them; (ii) the user isable to detach the suction tube from the device without losing vacuum pressure that leadsto device detachment; (iii) the user is able to control vibration fi1nction by means ofwireless remote control; (iv) the user interface is via iOS, Android, or other mobileoperating system application on a Bluetooth enabled device or via an RF or Bluetooth keyfob styled controller; (v) the user is able to control vibration parameters such as pattemtransition speed and vibration amplitude; (vi) power is provided via an intemal rechargeable battery, not accessible to the user; (vii) the user is able to control/direct _15- vibration focus through pointing With finger on a Wireless enabled device; (viii) the useris able to control degree of motor overlap; (ix) the motor overlap optimized for organicfeel; (x) the device is enabled With basic rotational motor pattems; (Xi) the deviceWithstands an extemal force applied to the extemal shell (over the attachment area) by theuser; (xii) the shell Withstands sufficient vacuum cycles Without loss of integrity; (xiii)the user is able to customize the motor pattem including direction, motor selection,looping, and save / recall the customized pattem; and (xiv) the user is able to customizethe suction pattem and save / recall the customized pattem. Studies have shown thatdifferent areas of the female brain are activated When the clitoris is self-stimulated thanWhen the clitoris is stimulated by a partner and that often times a female can achieveorgasm easier through self-stimulation than When stimulated by a partner. With thecertain embodiments of the devices described herein, the female can record thestimulation pattem that allows her to achieve orgasm through self-stimulation and store itin the devices memory. Subsequently, the device can be used during intercourse to play the saved pattem such that the female can achieve orgasm as if she Were self-stimulating.

[102] Preferred attributes of certain embodiments include: (i) user adjustable suction forfixation and blood flow recruitment; (ii) user adjustable vibration for blood flowrecruitment and nerve stimulation; (iii) spatially differentiated stimulation via macro-motion or isolation & control of multiple stimulation sources; (iv) tether-less and Wearable during intercourse; and (v) customizable & reusable.

[103] One embodiment of a device includes: (i) a shell that houses a circuit andbattery and connects to suction zone; (ii) compliant Wings to improve attachment; (iii)multiple stimulators attached to inner Walls of compliant suction zone; (iv) motorsisolated from outer shell to minimize damping and non-specific vibration; and (v) suction applied from removable applicator causes Walls to move inWard improving tissue contact.

[104] In one embodiment of the device, a receptacle is coupled to a squeeze bulb forproviding suction to the receptacle. The squeeze bulb can be integral to the housing or itmay be removable. The receptacle is coupled to adhesive Wings capable of conforrning tointeract With tissue. The Wings are designed to conforrn to the anatomy and may include, for example, a butterfly-like shape. The Wings may help stabilize the device and maintain _16- contact with the device in the relevant anatomy. The edges of the wings and of the tissue contacting surfaces of the device are soft or radiused or both.

[105] Certain embodiments of the device include onboard circuitry, power, pump, orother electronic features. For example, the device includes an antenna for interacting with the remote controller, such as an RF antenna. The device includes a battery.

[106] Certain embodiments of the device are controlled by a remote drive connected via drive cable to vibratory and/or suction elements inside the wearable part of the device.

[107] Certain embodiments of the invention provide mechanical motion, preferablymacroscopic motion, to simulate the motions naturally used by women to stimulate theclitoris in contrast to high-frequency mechanical vibrations of certain prior art devices.Some embodiments provide multivariate stimulation of the clitoris via a stabilizedplatform. By mechanically stabilizing a platform, such as through suction attachment, it ispossible to create a broad array of stimulating effects directly against the target clitoraltissues. Such effects may be difficult to achieve on a non-mounted platform. Examples ofmacroscopic motions include a rotary motion, a linear stroking motion, a low frequency“thumping” motion, and combinations above. Such macroscopic motions may becombined with vibration, for example, simple vibration or multiple and/or complex waveforrn vibration.

[108] Certain embodiments of the device provide variable suction. In suchembodiments, the user may rapidly and easily adjust the suction levels. Further, in certainembodiments the variable suction is programmable such that the amount of suctionapplied by the device can vary according to a pattem. In some instances, the suctionpattem is complementary to the vibration and/or macroscopic motion pattems. The devicecontroller includes a means for controlling the suction pattems, pre-loaded suctionspattems, user-configurable suctions pattems, or combinations thereof The devicecontroller enables the user to selected pre-loaded combinations of a suction pattem, avibrational pattem, and/or a macroscopic motion pattem and also enables the user to design and select customized combinations.

[109] Figures 1A, 1B, 1C, and 1D illustrate different views of a device 100 according toone embodiment. Device body 110 is designed to comfortably and discreetly fit against the user°s body while remaining accessible and controllable. Device body 110 may _17- include onboard controller circuitry, such as a circuit board, as Well as a user control pad.Altemately or additionally, device body 110 may include an antenna for communicationWith a remote control device. Device body 110 may include a power source, such as abattery. Device body 110 is coupled to suction chamber 120. Suction chamber 120includes sealing edge 125, Which is capable of providing a substantially airtight sealagainst tissue. Sealing edge 125 may be a flange having a Wider Width than is pictured inFigures 1A through 1D. Suction port 130 is in fluid communication With the interior ofsuction chamber 120 and provides a connection to a suction device (not pictured), Whichcreated negative pressure Within suction chamber 120. Suction port 130 may also includea check valve or other one-Way valve such that When negative pressure is applied tosuction chamber 120 the check valve or other one-Way valve prevents suction lossthrough the valve. Optionally, device body 110 may include an onboard pump system toprovide the initial suction to suction chamber 120. Further, the onboard pump system mayfurther include a pressure sensor to maintain a desired level of negative pressure Withinsuction chamber 120 despite the presence of any leaks that may occur along sealing edge125. Although not pictured in this embodiment, device 100 may include the suctionchambers, sealing members, stimulators or other stimulation features, or combinations thereof, described in other embodiments herein.

[110] Figures 2A, 2B, 2C, and 2D illustrate different views of the device 100 accordingto one embodiment. These figures depict vibratory motors 180 arrayed Within the interiorof suction chamber 120. In certain embodiments, the vibratory motors 180 are miniaturecoin style motors, Which have an eccentrically rotating mass that provides vibratorymotion. Device 100 is designed such that the vibratory motors 180 engage tissue Whentissue is draWn into suction chamber 120. Vibratory motors 180 can be embedded in theWalls of suction chamber 120, or they may be otherwise mounted in connection Withsuction chamber 120. In certain embodiments, it is preferable to minimize the transfer ofvibration from vibratory motors 182 to the housing of suction chamber 120. Preferably,the majority of the vibratory energy is transferred to the tissue contacting vibratorymotors 180. Vibratory motors 180 may be vibrationally isolated from the rest of device100 by using mounting mechanisms that inhibit the transfer of vibrational motion to theWalls of suction chamber 120. As described herein, vibratory motors 180 may be individually addressable by the controller circuitry such that pattems of motion, and in _18- particular simulations of macroscopic motion, can be applied to the tissue in contact with the vibratory motors.

[111] Figures 25A and 25B illustrate a charging station 2000 for a device 2200 and akey fob style controller 2300. Charging station 2000 can be plugged into an electricaloutlet via cord 2050. Device 2200 can be placed inside device cavity 2250 and controller2300 can be placed in controller cavity 2350. The walls of the cavities can have chargingcontact points, such as contact point 2255, for charging the device battery. Or, the batteryof device 2200 can be charged by induction. Station 2000 can contain a comparativelyhigh capacity battery that is charged via cord 2050 and is capable of holding charge andalso recharging the comparatively smaller capacity battery in device 2200 when station2000 is unplugged from an electrical outlet. Controller 2300 can be also be charged bythe methods described herein or their equivalents. Figure 25C depicts device 200 incharging cradle 2, which has the same attributes as the charging station depicted inFigures 25A and 25B. That is, cradle 2 is capable of charging device 200 by induction,contact points, or other means and contains a rechargeable battery capable of charging the battery within device 200.

[112] Figure 3A illustrates three vibratory motors 180 encapsulated in a membrane 190.Membrane 190 is configured to be inserted within a suction chamber of a device.Membrane 190 provides a safe, comfortable, and reliable protective barrier aroundvibratory motors 180 within a suction chamber. The protective barrier helps reduce tissueirritation and provides a way to clean and reuse the device. As pictured in Figure 3B,membrane 190 has a convex shape, which def1nes an interior portion into which tissue isdrawn. Membrane 190 has at least one, but preferably more than one holes, perforations,slits, or combinations thereof, to allow deformation of the membrane and airflow. Duringuse when suction is applied through the suction port to the suction chamber tissue isdrawn in to the suction chamber and against membrane 190. Membrane 190 deformstowards the interior of the suction chamber while maintaining intimate contact betweenvibratory motors 180 and tissue. Figure 3A depicts two of the vibratory motors as beingconfigured to be placed end on against tissue. Any number of the motor(s) can be used and any number may be configured to be placed on end. _19-

[113] Figure 3B illustrates a perspective view of the tissue-contacting side of device 100according to an embodiment. In this embodiment, vibratory motors 180 are spacedrelatively close together and thereby form a cavity that is sized to approximate thevolume of clitoral tissue to be engaged by the device. Figure 3C illustrates a close-upview of clitoral tissue cavity. Suction inlet 132 is depicted at the approximate apex of theclitoral tissue cavity, but the inlet can be offset to one side rather than being at the apex.Further, suction inlet 132 can be physically offset from the clitoral tissue cavity by aperrneable membrane, mesh, or other offset structure. In other words, a fabric or meshscreen can be placed over suction inlet 132 to prevent tissue from becoming trappedinsider the suction inlet. For example, an expanded PTFE membrane can be used as theoffset structure to provide and maintain a vacuum path between tissue and the suctioninlet. Figure 3C illustrates protrusions 133 as forrning an offset structure. Still further,suction inlet 132 may be physically offset from the clitoral tissue cavity by a narrowchannel that is too narrow for clitoral tissue to penetrate. Still further, suction inlet 132can include multiple smaller diameter suction inlets recessed among protrusions. Suchoffset structures can be combined. Still further, the motors can be sufficiently prominentor protruding from the surface of the flexible membrane (while still being covered by themembrane) to function as offset structures that hold back tissue from blocking the suctioninlet region. The offset structures fianction to prevent tissue from completely coveringsuction inlet 132, which could cause a drop in vacuum flow as well as damage or pain to tissue.

[114] Figures 3B and 3C show the miniature coin-style vibratory motors 180 are deeplyrecessed into membrane 190 such that one third to one half of the motor extends beyondmembrane 190 and toward tissue. Deeply recessing the motors places them closer totissue and provides a deep clitoral tissue cavity. Close proximity to tissue and a deepclitoral tissue cavity can each provide higher stimulating forces as compared to shallowlyrecessed motors. It is advantageous to transmit as much force as possible from the motorto the tissue, particularly in the embodiments in which the device is maintained in contactwith tissue by suction. In such embodiments, it is advantageous to transmit the forceefficiently to tissue since the motors are relatively low power and force losses will dampen the stimulation effect. _20-

[115] Figures SB and SC depict channels 192 in membrane 190 that at least partiallysurround the recessed portion of vibratory motors 180. Channels 192 can be a thinned outportion of membrane 190 and can be part of the membrane mold or can be created byremoving material from the membrane after molding. Channels 192 function to helpprovide and maintain a vacuum path between tissue and the suction inlet by providing a“leak path.” As discussed above, it is preferable in certain embodiments to maintain aflow path to suction inlet 132. Channels 192 also fianction to isolate the vibration of agiven motor from the rest of the membrane and the body of the device. Being thinnerregions than the surrounding membrane, channels 192 can flex more and reduce orprevent vibrational energy loss that might otherwise be transmitted to the relativelythicker and less flexible parts of the membrane. Minimizing or eliminating vibrations inthe membrane from being transmitted to the device body has the advantages of avoidingundesirable effects such as noise, discomfort, reduced stimulation, and reduced suction (by virtue of losing the seal provided by the sealing edge).

[116] Figures 4A and 4B illustrate views of a suction chamber 120 and vibratory motors180 according to an embodiment. Figure 4A depicts a view of the interior of suctionchamber 120 and depicts stimulating features 185 coupled to vibratory motors 180. Whentissue is drawn into suction chamber 120, stimulating features 185 transmit vibratoryenergy generated by vibratory motors 180 to the tissue. Stimulating features 185 mayhave a variety of shapes, textures, and conf1gurations. Stimulating features 185 may bedifferent in a single device and may be interchangeable, replaceable, and customizable.Figure 4B depicts a view of the outer surface of suction chamber 120 and illustrates the arrangement of vibratory motors 180.

[117] Figures 5A and 5B illustrate the use of suction chamber 120 and miniaturevibratory motors 180 according to an embodiment. In this embodiment, miniaturevibratory motors 180 are cylindrical in contrast to the disk-like miniature coin-stylemotors. Vibratory motors 180 are coupled to stimulating features 185 to transmit vibratory energy to tissue.

[118] Figure 6 illustrates a view of a device according to an embodiment. Stimulators180 are spaced apart by isolating arms 188. Isolating arms 188 provide a sub-assembly in which stimulators 180 can be assembled. Isolating arms 188 fianction to isolate the _21- vibrational energy of one stimulator from another stimulator. This is useful incircumstances where the stimulators are activated at different times and/or at differentfrequencies and/or at different amplitudes. By isolating the vibrational energy generatedby one motor from the vibrational energy generated by another motor, it is possible tosimulate macroscopic motion around or on tissue. Figure 6 depicts one type of vibration iso lation, but other types and their equivalents are within the scope of this disclosure.

[119] Figure 7 illustrates a view of the device 100 and an embodiment of a garrnent 50.In this embodiment, garrnent 50 is a simple strap or belt that connects to device 100 andhelps maintain its position on the body of the user. In certain embodiments, garrnent 50 isoptional as device 100 is configured to maintain its position on the body primarily viasuction. However, it is understood that for some users an additional means of maintainingthe position of device 100 may be desirable. Further, it is understood that device 100 maybe configured to be attached or could be otherwise integral with other garrnents includinglingerie or other women°s intimate apparel. Jewelry with functional elements thatstimulate other areas of the skin can be used to increase arousal. Such functional elementscan be one or more of air blowing across the skin, stroking of a soft element, application of slight Warming or cooling.

[120] Figures SA, SA°, SB, SB°, SC, and SC” depict a device 200 according to anembodiment. Device body 210 includes suction chamber 220. Suction chamber 220includes sealing and stabilization flange 225, having a sealing edge 226, which is adaptedto provide a substantially airtight seal against tissue. Suction port 230 provides fluidcommunication between the interior of suction port 220 and a suction device (notpictured). Device body 210 includes a user control area, which in this embodimentincludes activation button 205. It is understood that the user control area may containmultiple control inputs. Further, the device 200 may be controlled remotely. Figure SBand SB” illustrate a bottom view of device 200 and depicts the interior of suction chamber220. Multiple stimulators 2S0 are coupled to the inner walls of suction chamber 220.Suction inlet 232 includes a check valve or other one-way valve connecting suction port232 to the interior of suction chamber 220. Figure SC and SC” depict a cutaway view ofdevice 200 and illustrates, in addition to the features already described, controller block215. Controller block 215 is electronically attached to the user control area and/or remotely controllable by a remote control device via an antenna. Device body 210 _22- provides a safe, reliable, and comfortable protective barrier, which protects the electronics in controller block 215.

[121] Suction ports can connect to suction devices using various types of fluidconnectors, including but not limited to snap fittings, quick-release fittings, screw fittings, luer lock fittings, push-in fittings, magnetic couplers, and their equivalents.

[122] Device body 210 includes a firm but flexible shell, which houses electronics andcouples the electronics to suction chamber 220. Device body 210 may further include acharging port to recharge the power source included in controller block 215. Activationbuttons present in the user control area may be recessed or otherwise made comfortable, safe, and reliable.

[123] Sealing flange 225 may include soft, flexible, compliant material, such as silicone,gel or closed cell polyurethane foam, and may optionally be mildly adhesive to tissue ormay be adapted to contain an adhesive material. Also, the foam or other material couldcontain a lubricant that serves to fill gaps in the seal between the sealing flange andtissue. Other structures, such as filaments structures like velour or corduroy or otherwoven or non-woven fabrics can be used at the sealing flange in conjunction withadhesives and/or lubricants to provide a secure fit and help minimize leak paths. In someembodiments a fabric used in the sealing flange may be moisture responsive such that it“clings” or otherwise forms a close bond with skin and mucosa when the fabric becomeswet. The moisture may come from the user”s body or may be applied in the form of lubricant, adhesive, or simply water or saline.

[124] Figures 24A, 24B, 24C, and 24D illustrate different views of device 200according to another embodiment. Device 200 includes device body 210, which canhouse controller circuitry, and suction chamber 220. The controller circuitry can beaccessed using an interface mounted on device body 210 and/or via a remote controller.The remote controller can be physically tethered to device body 210 or it can bewirelessly connected. Suction body 220 includes sealing and flange 225, which is adaptedto provide a substantially airtight seal against tissue. The various views of Figures 24A,24B, 24C, and 24D illustrate certain features of the shape and form of device 200 whichpromote comfortable, discreet, and secure attachment of device 200. For example, device 200 is sized such that the attachment area, defined by area where sealing flange 225 _23- meets Suction Chamber 220, fits between the labia majora inferior to the clitoris anddevice body 210 may exit the labia majora superior to the clitoris. Further, the taper of theupper section of suction chamber 220 facilitates comfortable, discreet, and secure fit. Thecurve of device body 210 can help device 200 conforrn to the user and allow discreet placement inside garrnents.

[125] Specifically, the front section 225f of sealing flange 225 is placed superior to theclitoris and tucked under the anterior commissure of the labia majora. In that position, thelabia majora inferior to the anterior commissure can snugly engage the tapered section220t of suction chamber 220 such that substantially the entire front and lateral portions ofthe sealing flange 225 are tucked under the labia majora. Advantageously, the taperedsection 220t of suction chamber 220 allows the labia majora to comfortably engage acomparatively narrower section of the device while vaginal tissue superior to the vaginal orifice engages the comparatively wider sealing flange 225.

[126] Proper placement of device 200 can be easily and repeatably achieved byfollowing a few steps. For example, when a user first attempts to place the device, theymay benefit from the use of a mirror such that the user°s head and shoulders are proppedup and they can use the mirror to observe themselves placing the device. The user canopen their outer labia so that they can see their inner labia and the hooded glans of theclitoris. Users can identify a groove within their outer labia that runs along the inner labiaat the bottom and the hooded clitoris at the top. Device 200 can be effective when thesealing flange 225 is centered over the clitoris and the comparatively soft edges of thesealing flange 225 fit into the groove. In some cases the user can tug their outer labia tomake space for the outer ring to fit snugly in the groove. The vibratory motors can then fitsnugly around the glans of the clitoris. In some instances, the user can apply an amount ofa lubricant (such as a water-based lubricant) to coat their inner and outer labia, the glansof the clitoris, the hood of the clitoris, and the comparatively soft edges of the sealingflange 225. The user can activate the vibratory motors at a relatively low power setting tohelp place the device. By using the sensation from the low power vibrations as a guide,the user can ensure that the clitoris is placed snugly within the space defined by the innerportions of the vibratory motors. In some cases, the user can apply stimulation with theirinner labia separated. A properly placed device will be high enough on the user°s vulva to effectively cup the clitoris and not block the urethra or the vaginal opening. _24-

[127] In certain embodiments, multiple vibratory-disc, or miniature coin-style, motorsare embedded in the wall of a flexible suction chamber. In certain embodiments, themotors are embedded in a flexible membrane, which is attached to the walls of thesuction chamber. When suction is applied, tissue is brought into contact with thestimulator. The motors can be controlled by controller circuitry to produce one or more ofthe following pattems: (i) all on; (ii) clockwise; (iii) counter clockwise; (iv) up-down; (V)lateral; (vi) all pulse; (vii) selected motor pulse; (viii) gradients in frequency; and (ix)gradients in amplitude. The translation of the vibratory pattem and spatial iso lation of themotors may produce a desired effect of simulating macroscopic motion withoutincorporation parts that actually move in macroscopic dimensions. Stiffening membersmay be added to the motor mounts to vary and/or isolate vibration. The inner surface ofthe membrane may be textured to transmit vibration to tissue. The flexible membranereduces or eliminates the coupling of the motor vibration to the device housing and increases or maximizes energy delivery into the tissue.

[128] In one embodiment depicted in Figure 3B, pattems are created by three vibratorymotors. For example, rotational pattems (clockwise or counter clockwise) are created byfirst activating motor l80a and then activating motor l80b and then activating motorl80c. After a motor is activated it can be completely deactivated or have its powerreduced such that a pattern of higher power vibration rotates around the array of motors.As another example, a V pattem of vibration is created by simultaneously activatingmotors l80a and l80b, then deactivating both, and then simultaneously activating motorsl80a and l80c and then deactivating both. The V pattem can then be repeated. As anotherexample, a lateral pattem is created by altemating activation and deactivation of motorsl80b and l80c while motor l80a remains deactivated. As another example, a lateralpattem is created by altemating activation and deactivation of motors l80b and l80c while motor l80a remains activated.

[129] The pattems described above and equivalent pattems can be created by arrayswith more than three motors. Rotational pattems, lateral pattems, vertical pattems, andcombination thereof can be created by selectively activating and deactivating motors. Allsuch pattems are within the scope of the invention disclosed herein regardless of thenumber of motors. Further, in embodiments herein in which vibratory motors are depicted as providing the stimulation, other stimulators can be used in place of or in addition to the _25- vibratory motors. That is, one or more of the vibratory motors can instead be an electrical stimulator, temperature stimulator, or other stimulator. [l30] In certain embodiments, multiple vibratory motors create resonance or diphasicamplif1cation. Resonant or diphasic amplification patterns may be advantageous becausethey may create unique vibratory pattems that would be difficult to achieve with a singlevibrating source, and they may create amplif1cation in vibratory power that exceeds thecapability of a single motor. Such amplif1cation may be useful in the case of certainelectrical power or space constraints. Resonance or diphasic amplif1cation createdthrough the use of multiple vibratory sources may employ different sources includingrotary motors, linear motors, and piezoelectrics. The combination of multiple sourcesmay create a large range of customizable and selectable resonant pattems. Further, motorsof different sizes and/or power can be used to create multiple resonant frequencies to amplify the vibration effect. [13l] Multiple, isolated and independent motors may combine to produce diphasicamplif1cation or resonant pattems and/or may simulate macroscopic motions. Transitionsbetween motors are smoother with sine wave than square wave. Optimizing the timingand the amplitude of the motion during transition improves the “organic” feel of thestimulation. Preferably, multiple small motors are used to provide easily-differentiatedstimulation and simulation of macroscopic motion. Small eccentric motors placed onedge provide a focused vibration point, which promotes differentiation among severalvibration sources. Slower vibration transitions promote differentiation among several vibration sources as compared to more rapid transitions.

[132] In certain embodiments, devices provide macroscopic motion in addition to, or instead of, simulating macroscopic motion.

[133] Figure 9 depicts a device 300 that provides macroscopic motion according to anembodiment. Device 300 includes suction chamber 320 and sealing edge 325, which areboth configured to engage tissue as described herein. In this embodiment suction chamber320 is flexible and deformable such that motor 380 deforms suction chamber 320 as ittraverses suction chamber 320 via rails 370. Motor 380 may be coupled to a cylinder ormay itself be a cylinder, which rolls, slides, or otherwise moves along rails 370. The motion of motor 380 across suction chamber 320 simulates a stimulating stroking motion _26- and promotes blood flow and/or clitoral engorgement. Suction Chamber 320 includes asuction port (not pictured), which is used similar to suction ports described herein andincludes a check valve or other one-way valve to maintain suction in the chamber. Motor380 may vibrate in addition to traversing rails 370 and thereby provide both a stroking motion and a vibratory motion.

[134] Figure 10 depicts an embodiment of a device 400 providing macroscopic motionaccording to an embodiment. Device 400 includes device body 410 and dome 420. Dome420 is conf1gured to rotate with respect to device body 410 about an axis central to bothdevice body 410 and dome 420. Stimulating features 485 are coupled to dome 420.Suction port 430 operates to provide suction to the interior of device body 410 to drawtissue into contact with stimulating features 485. A motor (not pictured) drives therotation of dome 420 with respect to device body 410 and rotates stimulating features 485about the clitoral tissue drawn into the interior of device body 410. Stimulating features485 may also be driven by vibratory motors to provide both a stroking motion and a vibratory motion.

[135] Altemately, the motion of the dome may be driven magnetically. For example,dome 420 may include a single offset magnet. Device body 410 may include severalelectromagnets, which are individually addressable by a controller. The motion of the dome can be driven by selectively charging each electromagnet in a sequence or pattem.

[136] Figure 11 depicts one embodiment of a device 700 in which a moving tread 775under a stationary membrane 790 provides macroscopic motion for stimulation. Themoving tread 775 is housed under a thin membrane 790, which is compliant and flexibleand moves with features on the tread. The tread 790 has raised regions 777 spaced apartfrom each other at physiologically-relevant spacings. The tread rides on two or more rollers 779, at least one of which is powered to cause the tread to rotate.

[137] Figure 12 illustrates a device 500 according to an embodiment. Device body 510is attached to flange 525, which is conf1gured to maintain a substantially airtight sealagainst tissue. The tissue-contacting surface of flange 525 may include a mild adhesive,and/or an adhesive substance may be applied to the tissue-contacting surface of flange525. Optionally, a lubricant and/or an exothermic substance may be applied to the tissue- contacting surface of flange 525. Flange 525 is flexible and conforrnable and adapted to _27- provide a reliable and comfortable anatomical fit. Device body 510 includes a suctionChamber (not pictured) capable of drawing tissue into its interior. Device body 510includes vibratory motors 580 capable of delivering spatially-isolated vibration to tissue.Device body 510 included activation button 505 in a user-accessible location, such as on the side of the exterior of the suction chamber.

[138] Figure 13 illustrates a device 600 according to an embodiment. Device 600includes suction chamber 620, which is configured to apply suction to tissue through asuction port or other mechanism as described herein. Device 600 includes a stimulator680 and power source such as a battery. Stimulator 680 is suspended from suctionchamber 620 via an adjustment arm 640. Adjustment arm 640 allows a user to preciselyand repeatably control the force of contact between stimulator 680 and tissue. Device 600includes an activation button 605 and can include remote control capabilities via anonboard antenna. Altemately, the adjustment arm can be electronically controlled, such asby applying current through a nitinol arm to control the position of the motor relative to tissue.

[139] Figures 14A and 14B illustrate one embodiment of a device 800, which includes athin flexible membrane 810 designed to deliver a pulsating wave along its length. Aflexible electronic controller 850 drives one or more flexible actuators 860 that are atleast partially encapsulated in the thin flexible membrane 810. The flexible membranemay have a curved configuration that def1nes an intemal chamber. Suction can be appliedto the intemal chamber through various mechanisms, including a deformable suctionchamber 820 attached to the membrane 810. Optionally, when the membrane is exposed to air a mild exothermic reaction occurs to further stimulate blood flow.

[140] In one embodiment of the device, the device could create a sweeping wavemotion. The speed and amplitude of the wave is variable, selectable and adjustable in realtime. The wave motion can also be used to deliver therapeutic substances directly to thegenital region. The substances can be stored in the polymeric adhesive region orimmediately behind the adhesive region. The mechanical displacement algorithm or,altemately, an algorithm focused on delivery, could be used to meter out drug at thedesired rate. Thin-film actuators include shape memory polymers and metals, ferroelectric thin f1lms, polymer thin f1lms, piezoelectric f1lms, polymer/metal _28- composites, and combinations thereof Light or electromagnetic radiation can be used to power the actuators.

[141] In certain embodiments of the invention, wave motion can be achieved bysequentially charging regions of the thin-film actuator. As each region is energized, thatregion undergoes a conforrnational change that causes a local displacement of thestructure. Various temporo-spatial patterns can be created to stimulate a stroking motion.Altematively, some regions may be made to vibrate all other regions provide a simulatedstroking motion. The thin-film may be electrically activatable polymer, a piezoelectricmaterial, shape memory polymer, a shape memory metal, or composite materialcontaining one or more of the following materials: metals, polymers, particles, strips,charge elements, water, salt, bases, acids, etc. In some embodiments, the thin filmactuator is formed from graphene, which is capable of being driven by current to deliver vibration stimulation, simulated macroscopic motion, and/or macroscopic motion.

[142] Figures 15A and 15B illustrate an embodiment including a magnetically coupledthin-film actuator 900 and controller 950. The thin-film actuator 900 is applied to theclitoral hood and the controller 950 is placed into the vaginal vault. The controller 950delivers a variable wave electromagnetic energy to the thin-film actuator 900, causing theactuator to vibrate. If the electromagnetic energy is provided by a rotating magnet, themagnet may be eccentric in weight. Such eccentricity allows for local vibration or mayalso be weighted such that only the thin-film actuator is vibrated. The thin-film may bedisposable and comprised of other magnetically adherable material. The controller maybe onboard the device or maybe remote. The density of the magnetic element allows forvariable focus of actuation along the surface. There may be an adhesive layer 910, such asa mildly adhesive polymer layer, to adhere to tissue. The vibration is caused byelectromagnetic activation of magnetic layer 915, which resides between adhesive layer910 and surface layer 920. The controller includes a rotary magnet, a motor, circuitry, andthe power source such as a battery. The controller may be encapsulated for safety, reliability, and comfort.

[143] In another embodiment, a controller may be placed in an interior space of thevagina and physically tethered to a device placed about the clitoris. The controller and the device may be connected using a malleable connector to allow comfortable or tolerable _29- positioning of the device. Advantageously, by moving the relatively heavier control andpower components from the clitoral device to the vaginal device, the clitoral device maybe more comfortable and Wearable. The vaginal device may also include stimulating features such as vibrational motors.

[144] Figure 16 illustrates an embodiment of device 1100 in Which a stimulator 1180 isin contact With the top or anterior surface of a suction chamber 1120. Device 1100includes flange 1125, Which provides a substantially airtight seal With tissue While beingreasonably comfortable and Wearable. Suction chamber 1120 draWs tissue into its interiorusing a separate suction device or by deformation of the suction chamber prior to thedevice 110 being placed in contact With tissue. When tissue is draWn Within suctionchamber 1120, stimulator 1180 (or more than one stimulator) may be used to stimulateclitoral tissue. Stimulator 1180 (or motors) may be controlled via a user control area on device 1 100 or remotely.

[145] Certain embodiments of the invention take advantage of a Wide spectrum ofinput, Wider than the input available from certain prior art devices. For example, inputmay include complex Waveforrns such as literal music, or superimposed Waveforrns thatmake up a type of “song.” The multiple oscillations of a “song” can produce a desiredmechanical effect on the actuators in contact With tissue. The location or spatialplacement of these “songs” could be distributed differentially across the target tissuesurfaces to produce enhanced effects. For example, some regions may be more optimallystimulated through low-frequency pattems in other areas through higher frequencypattems. High amplitude pattems in combination With variable mid to high vibrations arealso possible. By adjusting these effects spatially, the simulation of manual stimulation,lingual stimulation, or intercourse may be achieved. Multiple stimulation signatures areavailable to the user to produce different effects. Nominally, some tissue may respondmore to a simulated “rubbing” effect and others to a more cyclic “depression” orthumping effect. The “songs” may be downloadable to a remote player or to the deviceitself through Web-based media marketplaces, such as iTunes. Figure 17 illustrates adevice 1200 that includes an array of acousto-mechanical drivers 1282, or voice coils(e. g., “speakers”) to create a variable assortment of stimuli across the surface. Each driver1282 is individually addressable by a controller to generate the complex Waveforrns and pattems of stimuli described herein. _30-

[146] Figures 18A and 18B illustrate the interaction of a device 1300 and a separatesuction device 1320. The combination of device 1300 and suction device 1320 provide akit for use according to embodiments described herein. Device 1300 includes a suctionport 1330 that is in fluid communication With the interior of a suction chamber (notlabeled) on device 1300. Suction device 1320 is depicted as a syringe-type suction devicebut other suction devices are Within the scope of this disclo sure. A separate suction devicealloWs for the precise, repeatable, and reliable application of suction and as Well as discreet and comfortable wearing of device 1300.

[147] Figure 19 illustrates an embodiment of device 1400 in Which a stimulating feature1485 is driven by a motor housed Within a device body 1410. Device 1400 is placed incontact With clitoral tissue by suction means described herein or by placing the device inclose contact With tissue via a garrnent or garment-like apparatus. Stimulating feature1485 provides macroscopic motion to stimulate engorgement of the clitoris by providinga more natural stroking and/or lingual motion as compared to a vibratory motion. Device 1400 may include one or more stimulating features.

[148] In certain embodiments, the controller is designed to map the user°s motions on acontrol surface to the tissue-contacting surface of the stimulating part of the device. Bypressing their fingers on the control surface, the user can create various levels of pressurea vibration in the corresponding location on the tissue-contacting surface. As the usermoves their fingers across the control surface and optimally desired Way, a sequence ofmotions, pressures, vibrations, and/or stimuli that mimic these actions are created on thetissue-contacting surface. These movements and inputs can be stored either locally on thedevice or a controller level and played back When desired to create desired effect Without requiring the user to repeat their input pattem.

[149] Figure 20 illustrates an embodiment of a device 1500, Which can be remotelycontrolled by a touchpad device 1550 to provide precise and customizable stimulation.Touchpad device 1550 may be a smartphone or other equivalent device. Device 1500includes electro-active layer 1580, Which directly contacts tissue or contacts tissuethrough a thin membrane. Tissue is draWn into contact With electro-active layer 1580through methods described herein. Device 1500 includes a power source 1515, a local controller 1505, and an antenna 1535. Electro-active layer 1580 is conf1gured to mimic _31- the motion and pressure applied by the user”s finger on the touchpad device 1550 to the clitoral tissue within device 1500.

[150] In certain embodiments, a remote controller is a controller conf1gured to sendradio-frequency signals to the device wom by the user. The controller may be sizedsimilar to a key fob remote control commonly associated with automobiles. A key fobstyled remote can include several buttons capable of controlling the fiall range offunctions of the device discussed herein. Figures 26A and 26B illustrate a key fob styledremote controller 206 and device 200, which includes a complementary housing space202 such that the remote 206 can be docked with the device and housed there when not inuse or even when in use. In general, the controller circuitry can include a circuit board, amplif1ers, radio antennae (including Bluetooth antennae).

[151] Devices using low power Bluetooth or other radio antennae may experiencedropped connections when the remote/device pair is separated by distance or by aphysical obstruction (such as a user°s or partner°s body). In such cases, it is desirable forthe device to remain operating under its pre-drop operating conditions while the remoteattempts to automatically pair again with the device. Said differently, it is undesirable torequire the user or partner to have to manually re-establish the Bluetooth pairing betweenthe remote and the device if the pair connection is lost during device use. And, it isundesirable for the device to cease operating under its existing pre-drop conditions if apair connection is lost. Thus, certain remotes are conf1gured to automatically re-establish the pair connection with the device without requiring user intervention.

[152] In situations where the remote automatically re-establishes the pair connectionwith the device, it can be important for the remote to query the device for the currentdevice operating conditions. That is, since the device has maintained a state of operatingconditions when the pairing was lost, it is desirable that the remote not interrupt thedevice operating conditions when the pair connection is re-established. As a counterexample, in some Bluetooth pairings, after the pair connection is established the “master°controller will send a reset signal to the “slave” device. Such a reset would be undesirablein the circumstance where a device is operating under a given set of parameters, pattems,or programs because those parameters, pattems, or programs would be interrupted by the reset signal. Such an interruption could be detrimental to the user experience. _32-

[153] In certain embodiments, the controller is physically tethered to the device wom bythe user. The tether can include electrical connection as well as a fluid connection to provide suction to the suction chamber on the device.

[154] In certain embodiments, the stiffness of parts of the device, such as the suctionchamber, an arrn suspending a vibratory motor, or stimulating feature, can be controlledby moved a stiffening member, such as a stylet, in or out of a receiving lumen in the part whose stiffness is being controlled.

[155] Figure 21 illustrates an embodiment of a device in which stimulator 180 iscoupled to the end of lever 195. Lever 195 has an interior receiving lumen for receiving astiffening stylet. By stiffening lever 195, which may be attached to a device body, or to asuction chamber such as the chamber pictured in Figure 13, the stimulator 180 may bemade to more firmly engage tissue. Figure 22 depicts an embodiment in which lever 195is coupled to oscillating motor 180, which is attached to suction chamber 120. Lever 195is driven to have a larger motion at its far end relative to the smaller motion of oscillatingmotor 180. In such an embodiment, lever 195 provides the sensation of macroscopic motion using the relatively small motions of the couple motor.

[156] Figures 23A and 23B depict an embodiment in which a stimulator 180 is mountedwithin suction chamber 120. Figure 23A depicts a sectional plan view and illustrates amechanism including two levers 195 and two pivot points 196. The pivot points andlevers cooperate to sweep stimulator 180 across the target tissue. While the mechanism isdepicted with two lever and two pivot points, other combinations of mechanical elementsare possible provided that they generate a controllable sweeping or stroking motionacross the target tissue. Figure 23B depicts a sectional end view, which illustratesstimulator 180 as both sweeping across tissue and pivoting about the longitudinal axis oflever 195. In certain embodiments, the pivoting motion is passive and conforrns to theshape of the tissue to maintain substantial contact between stimulator 180 and targettissue. In other embodiments, the pivoting motion is actively controlled and can be usedto deliver more stimulating force to target tissue. For example, as described herein,miniature coin style motors with an eccentric mass deliver more force when placed edge-on to tissue. By actively pivoting the motors, differential force effects can be achieved.

Pivot point 196 may also be passive or active in the sense that they may be motors _33- capable of driving the sweeping motion or they may be comparatively simple joint thatallow the motor to be swept across tissue by a driving force at one of the points or within the case of the device.

[157] Some of the embodiments of the device deliver suction to engorge and stiffen thetissues and vibration to provide stimulation to the region. In other embodiments, thedevice delivers suction to engorge and stiffen the tissues and electrical or neuralstimulation provides stimulation to the region. In other embodiments, Warming or coolingis applied, including light or infrared energy (e.g., near infrared light emitting diodes),instead of vibration or electrical or neural stimulation or in combination with thosestimulation types. The stimulation source preferably is in intimate contact with the tissue to optimize energy transfer.

[158] The mounting of the vibration sources may also allow for isolation so that there isspatial differentiation between sources and minimal diffusion of vibratory energy toadjacent structures in the device or tissue. Mounting stimulators on a flexible membranewhich travels with the tissue as it becomes engorged with suction may accomplish thesegoals. However, the membrane should have a direct path between the suction source andtissue - if there is no path the amount of suction delivered will be significantly lower.Placing holes or slits in the membrane may allow for suff1cient vacuum and energytransfer. However, holes or slits are placed in the membrane may allow fluid from thetissues to travel through the membrane into the interior vibration source region of the device.

[159] Figures 27A and 27B illustrate a plan view and a cross-sectional view of a deviceaccording to certain embodiments. Device 200 includes device body 210 and suctionchamber 220. Suction chamber 220 includes sealing flange 225 including sealing edge226, which is adapted to provide a substantially airtight seal against tissue. Suction port230 provides fluid communication between the interior of suction port 220 and a suctiondevice (not pictured) that can be detachable or remain attached. Device body 210 includesa user control area 215. It is understood that the user control area may contain multiplecontrol inputs. Further, the device 200 may be controlled remotely. Multiple vibratorymotors 280 are coupled to the inner walls of suction chamber 220. Suction inlet 232 includes duck bill valve 238 (or a check valve or other one-way valve) connecting suction _34- port 232 to the interior of suction Chamber 220. Device body 210 includes a f1rm butflexible shell, which houses electronics and couples the electronics to suction chamber220. Device body 210 may further include a charging port to recharge the power sourceincluded in controller block 215. Activation buttons present in the user control area maybe recessed or otherwise made comfortable, safe, and reliable. Sealing flange 225 mayinclude soft, flexible, compliant material (e.g., silicone), and may optionally be mildlyadhesive to tissue or may be adapted to contain an adhesive material. Device body 210 isconfigured such that the posterior, or underside, of device body 210 is in a different planethan sealing flange 225. This configuration allows device body 210 to ride over the pubicbone of the user and to optionally attach to a garrnent while sealing flange 225 is in contact with tissue.

[160] Figure 27B depicts suction tube 231 connecting suction inlet 232 with suction port230. The suction tube material is chosen to be resistant to adhesion by biological material.The path of the suction tube through the device housing can be configured to account forpressure drops and to avoid areas where fluid may pool. The suction tube provides anadditional barrier between fluid and the electromechanical and electrical components within the interior housing of the device body.

[161] In embodiments including a suction tube, there is a pressure differential betweenthe chamber above and below the membrane. When suction is applied, the area above themembrane is at higher pressure than the area below the membrane which can encouragethe membrane to move down toward tissue, thereby increasing contact forces between themotors and tissue. This pressure differential mechanism can be actively used to increase energy transmission.

[162] The challenge of cleaning fluid from interior regions of the device is addressed byenabling the flexible portion of the suction cup to be removed from the housing so it canbe cleaned by the user. Altemately, as depicted in Figures 27A and 27B, a tube could beconnected between the suction luer and a single hole in the membrane. The interior of thishole may have features (e. g., protrusions, a perrneable shield, and the like) to prevent thetissue from clogging the hole when vacuum is applied. In this case, fluid would not be able to enter the interior surfaces of the device and would be contained to the tissue _35- interface and the suction tube channel. These regions could be rinsed by the user without disassembly.

[163] To address the challenge of cleaning, in another embodiment as shown in Figure33, no fluid is allowed to enter the interior 282 of the device 200 such that the surfaceunder suction chamber 220 and all of the external surfaces of device 200 can be easilycleaned with soap and water. Interior 282 can be vacuum sealed or contain a gel or fluid.The embodiment of device 200 in Figure 33 has a non-deformable button 284. Button 284has an O-ring 286 to forrn a seal around the button. Button 284 is mounted on a spring288 such that when button 284 is depressed and released it is biased toward its startingposition. Sealing flange 225 creates a seal, primarily at sealing edge 226, with thewoman°s tissue. Suction chamber 220 is a resilient membrane dome that is biased toretum to its starting position. Displacement of button 284 forces pressure downward onthe resilient membrane dome which forces air out from under suction chamber 220. Thesealing flange 225 in contact with the tissue acts likes a one-way valve and as the buttonis released, the resilient membrane tries to retum to its starting position thus creatingsuction under suction chamber 220 to create negative pressure over the clitoris andencourage engorgement. A biasing member can be added to the suction chamber dome to increase the recoil.

[164] Figure 28 depicts a view of a device 200 with the outer housing removed.Controller block 215 (or circuit board) is housed undemeath the outer housing andbetween suction port 230 and activation button 205. Activation button 205 is, of course,operably connected to controller block 215 as is I/O port 218. I/O port 218 can plug intoan interface cable (or an interface port in a holder) that can be used to program and/or charge the device. Battery 212 is undemeath controller block 215.

[165] Certain materials may be preferable for use as actuators in devices disclosedherein. For example, electro-active polymers expand and contract with the application ofelectrical current and can incorporate taxels (focal points) to increase resolution. Electro-active polymers can be packed in dense arrays, are highly customizable, and show goodfrequency range. Some designs are extremely low profile. Piezoelectric materials areanother example. Piezoelectric crystals generate stepping function movement that can be used for rotary or linear motion and / or vibration. Piezoelectric materials can be _36- miniaturized and incorporated into electronics and show good frequency range. Anotherexample is voice coils in Which linear motion is caused by generation of electrical fieldaround a magnet. Voice coils can achieve high amplitude With low voltage and are smaller size than miniature coin cell motors.

[166] Voice coils can also alloW more control flexibility than rotary motors - thefrequency and amplitude can be decoupled from each other. Voice coils also allow forgreater isolation of vibrational energy because only the moving element vibrates and the housing is essentially stationary. This can alloW for greater spatial differentiation.

[167] Certain actuator materials may be used to form an actuator array that provideshigh spatial resolution for vibrations. For example, an array that provides for l4 vibratorysources could improve the sensation of motion delivered to the user and provide forsignificant customization modes. In this example, each vibration node is 4mm indiameter, significantly smaller than the 8 to l5 mm diameter coin cell motors. A vibrationnode of 4 to 6 mm in diameter Would be desirable for this application to achieve the intended resolution.

[168] Certain embodiments are capable of approximating kinesthetic forces (ormacroscopic motions such as palpation or rubbing) using an array of vibrational motors.Devices disclosed herein are capable of achieving (or at least simulating) kinesthetic (ormacroscopic) sensations using actuators that typically produce only tactile sensations.Devices capable of producing a convincing, organic-feeling palpation sensation rely onthe coordination of: (i) motor spacing in the array (preferably, motors are spaced at aboutl-4 mm); (ii) breadth of field of each motor; (iii) traversal rate for a pattem played on the motors; and (iv) overlap.

[169] According to certain embodiments, devices fabricated as described herein are ableto tune strength, traversal rate, and overlap, to the fixed physical parameters like themotor spacing, skin contact, etc. Various algorithms alloW independent control of motorstrength, traversal rate, and overlap. In a device fabricated according to embodimentsdisclosed herein, an algorithm Was implemented in a low-cost embedded microcontroller.Three input parameters Were varied, by radio control using Bluetooth Low Energycomponents communicating from an iOS device (iPod of iPhone 5 generation) to an embedded microcontroller (Texas Instruments CC2540), to ultimately set those algorithm _37- input parameters. The algorithm output controlled pulse width modulated drives for all 3to 5 motors simultaneously. The algorithm also allowed for unique patterns such that theuser could specify order of traversal through the motor array. Different profiles, e.g.square, sine, ramp, were used to turn on the different motors at different rates as the pattern progressed through the motor array.

[170] For motors with a non-linear response curve, feed-forward techniques (or feed-back if sensors are incorporated in the device) can compensate for such a response curve.Thus, motors turn on when commanded as opposed to with a lag, so that the coordinationdiscussed above can be achieved. In some embodiments, an accelerometer may compensate for effects of gravity. [l7l] Miniature coin-style vibratory motors having an eccentric mass are used in certainembodiments. Generally speaking, coin-style motors require larger masses and higherpower in order to increase the stimulating force delivered to tissue. Thus, the stimulatingforce in eccentric motors is a fianction of mass, and more power is required to drive thatmass. In certain embodiments described herein, despite the relatively high mass andrelatively high power of the motors the devices can provide spatially-differentiatedvibration via the iso lation structures and methods described herein. Even when the motorsare positioned relatively close together to provide a close fit to the clitoris, embodimentsdescribed herein can provide substantial vibrational isolation and provide the user with a spatially-differentiated stimulation experience.

[172] In certain embodiments, modified voice coils are used as the stimulators. Asdescribed above, voice coils can achieve high amplitude with low voltage and are smallersize than miniature coin style motors. Voice coils can be modified to include a massattached to the membrane driven by the electromagnetic field. Advantageously, suchmass-bearing voice coils retain the desirable properties of voices coils, including rapidresponse time, independent control of frequency and amplitude, high acceleration, high precision force control, and relatively low power consumption.

[173] Embodiments of the device may have variable suction controlled by the user oranother remote controller. A user may remotely select a pressure and the device willchange to that pressure within seconds. The device may include an onboard pump that maintains suction and/or goes up/down from that initial established suction. Certain _33- diaphragm pumps may be used as onboard pumps. Further, the motor driving thediaphragm pump may be used to produce vibratory motion. In certain embodiments, theonboard pump can be a modified voice coil designed to mimic the action of a diaphragmpump. The onboard pump can altemately be made with using a voice coil actuator that moves a membrane in a sealed and valved chamber.

[174] In embodiments using an onboard pump or in embodiments using a remote pump,the suction may be programmed to complement the vibratory motion of the motors or themacroscopic motion of stimulators in the device. The algorithms described herein to drivevibration are adapted to vacuum pump system to provide fast response times andphysically differentiable levels of suction to the clitoris. Further, certain embodiments usesimultaneous or sequential suction waveforrns or algorithms and vibration waveforrns or algorithms to amplify the effect of the device.

[175] In some embodiments of the device and method, variations in the stimulationparameters are particularly useful in providing the desired results in a user. For example,the stimulators can be varied between a high power and/or a high frequency level and acomparatively lower power and/or lower frequency setting. In the case of coin cell typestimulators, power and frequency are coupled such that driving the stimulator at higherfrequency of oscillation also drives the stimulator at a higher power. To achieve thepreferred variations in stimulation, the coin cell type stimulators can be switched betweena high power threshold and a low power threshold. In the case of voice coil typestimulators, power and frequency can be decoupled such that a given power ofstimulation can be driven at any frequency. Without being bound to a specific mechanismor mode of action, it is believed that comparatively large variations in the power or intensity of the stimulation will produce as desirable user experience.

[176] One of the advantages of embodiments of the invention with multiple stimulatorsand suction pattems is that different parts of the anatomy can be stimulated at differentfrequencies. For example, different parts of the frenulum can be stimulated at differentfrequencies. It is generally understood that different nerve types will be stimulated to adifferent degree at a given frequency and that different nerves are more fully stimulated atdifferent frequencies. One of the advantages of certain embodiments is the capability of delivering the appropriate frequency and intensity stimulation and/or suction to the _39- different parts of the vaginal anatomy. For example, With the three stimulators positionedas shown the center stimulator primarily stimulates the glans of the clitoris and the rightand left stimulators stimulate the right and left crus, respectively, (and/or frenulum) of theclitoris. The device can also enable the user to select and/or tune the desired frequency for their anatomy and nerve distribution, thereby customizing the user experience.

[177] In certain embodiments, it is desirable to release suction during use. For example,the edge of the suction cup could be pulled back, squeezed, or manipulated to create aleak path. Further, a valve in line With the suction tube that can be manually manipulatedby the user to release suction. In embodiments using an onboard suction pump, the pumpcan be conf1gured to include a constant leak path that the pump overcomes - therefore, ifthe pump stops the device Will automatically release. Still further, the device can beconfigured With a button that the user presses Which opens a valve in the pump to releasesuction. Still further, the valve needed for the suction pump could be norrnally open.When power is supplied, the valve closes, completing the seal. HoWever, if power goes out, the valve Will open and the device Will release automatically.

[178] Certain embodiments of the present invention are designed and configured toincrease blood circulation in vaginal tissue to promote engorgement to the clitoris andextemal genitalia While simultaneously applying stimulation to the clitoris and/or othervaginal tissue. The clitoris is a sexual organ that is filled With capillaries that supplyblood to a high concentration of nerves. Certain embodiments increase blood flow to stimulate the clitoris and enhance a Woman°s sexual response.

[179] In Women presenting symptoms ranging from sexual dissatisfaction to sexualdysfunction, methods and devices of certain embodiments can provide: (i) increasedgenital sensation; (ii) improved vaginal lubrication; (iii) improved sexual satisfaction; (iv)improved sexual desire; and/or (v) improved orgasm. Certain embodiments of theinvention are designed and configured to be used to treat Women With diminished (i) arousal, (ii) lubrication, (iii) sexual desire, and/or (iv) ability to achieve orgasm.

[180] Certain embodiments of the invention are designed and configured to be aWearable device designed to increase sexual satisfaction. Certain embodiments of theinvention are designed and configured to be used as a “conditioning” product, to prime the user before a sexual event. Certain embodiments can be: used to help a Woman _40- prepare her body in advance of a sexual experience, typically With 5-30 minutes of useprior to sex; wom during a sexual experience with a partner, including intercourse; usedby a woman alone for recreational purposes to reach orgasm; used as a regime, typicallyused a few minutes every day, to help facilitate a more intense and pleasurable experienceduring intercourse with or without a partner; or used over time to help train the body to achieve a better natural sexual response.

[181] The device 200 is placed over the clitoris (Figs. 32A-32B) by a woman, herpartner or physician. Gentle suction allows the product to stay in place (so it can becompletely hands free once placed), although it can be quickly and easily removed asdesired. A woman can sit, stand up and walk around while wearing the device 200. Asshown in Fig. 32C, a small remote control 1550 or smartphone “app” is used to adjust thedevice”s vibration intensity and unique stroking pattems (such as the counter-clockwisemovement pictured in Figs. 32D-32E). The sequence can be customized in advance and““playlists” can be created. Once in place, the device 200 provides quiet, hands-free sexualstimulation to the clitoral region, working with a woman°s body to help improve sexualresponse. Certain embodiments are small (about 1.5 inches long by about 1 inch wide),quiet, waterproof and discreet. The product is latex-free, hypoallergenic and washablewith soap and water. It is quick and easy to place on the body, and can easily be removed.It may be wom under clothing without anyone knowing the user has it on. Since it is ahands-free product, the user can easily move around, stand or walk while wearing thedevice for a few minutes a day while doing something else to help a woman°s body maintain a higher level of sexual responsiveness.

[182] Figures 44A through 44C illustrate user interfaces for a smart remote controller1550. These user interfaces provide means for controlling vibration and suction pattems,including pre-loaded pattems, user-configurable pattems, or combinations thereof. Figure44A illustrates a user interface including a vibration on/off button 1551, a vibrationpattem selector 1552, a vibration strength selector 1553, and a vibration cycle speedselector 1554. The vibration strength selector 1552 and vibration cycle speed selector1554 are each shown with a numeric indicator in addition to a slider. The vibrationpattem selector 1552 can be loaded with pre-loaded pattems or it can be used to storeuser-configurable pattems. The user interface provides an intuitive and easy-to-operate means for controlling the vibration and suction pattems of the device. _41-

[183] Figures 44B and 44C illustrate a user interface including a suction on/off button1556, a suction level selector 1557, and a suction altemating speed selector 1558. Thesuction on/off button 1556 also includes an “altemating” section setting. Figure 44Billustrates that when the suction on/off button 1556 is in the “off° or “on” position, thesuction level selector 1557 has a single slider point and the suction altemating speedselector 1558 is not available to use. When the user sets the suction on/off button 1556 to“on,” the suction level selector 1557 can be used to set a suction level on the device and that suction level can be numerically displayed in units such as “in Hg.”

[184] Figure 44C illustrates a user interface in which the suction on/off button 1556 hasbeen set to “altemating.” In the “altemating” mode, the suction level selector 1557 hastwo slider points and the suction altemating speed selector 1558 is available. The“altemating” mode allows the user to set a primary suction level with the first slider pointand a higher suction level with the second slider point. The device can then altematebetween these two suction levels at a specific altemating speed that the user sets using thesuction altemating speed selector 1558. Thus, the user can control both the difference insuction levels and the speed at which the device altemates between those two suctionlevels. Further, the user interface can contain a means for the user to store the two suctionlevels and the suction altemation speed. The user interface can include pre-loaded suctionaltemation levels and speeds, user-configurable suction altemation levels and speeds, or combinations thereof

[185] Figures 34A through 34D illustrate views of a portion of certain devices withdifferent tissue contacting configurations. In each of Figures 34A through 34D, theinterior components, such as the portions that hold the vibratory motors, are visible sincethe outer shell of the device body has been removed. Figure 34A depicts the device ashaving a comparatively steeper curve along the tissue contacting side of the device. Thatis, the curvature of the sealing flange 225 from its approximate midpoint to the rearsection 225r of the sealing flange 225 has a greater curvature than that same section ofother device portions depicted in Figures 34B, 34C, and 34D. Further, the sealing flange225 of the device portion depicted in Figure 34A has a comparatively longer inferiorsection (the section is described as inferior due to its placement inferior to the clitoriswhen in use) or rear section 225r. This comparatively longer inferior section (or rear section 225r) is configured to conform to the anatomical curvature inferior to the clitoris _42- and to facilitate the interaction between the sealing flange 225 and tissue. The superiorand lateral flange portions are shorter relative to the longer inferior section flange portionto enable superior positioning relative to the clitoris and reduce interaction with the labiamajoria. For some users, this curvature will improve the fit, comfort, and reliability ofsuction attachment of the device. Other uses may find that the curvature of the devices depicted in Figures 34B, 34C, or 34D may be preferable.

[186] The portions of the device illustrated in Figures 34A and 34D can be formed froma molded piece 22. This single molded piece 22 includes the sealing flange 225 and upperportions that are connected to the device body. Figure 40 illustrates a perspective view ofa device and shows the single molded piece 22 attached to the device body 210 to formthe device. The upper portions of the single molded piece 22 are positioned inside thedevice body 210 such that the vibratory motors and the suction ports can be attached to the control mechanisms inside the device body 210.

[187] In some embodiments of the device, a removable flange assembly is provided.The flange assembly couples to the device body and is removable from the device body.Figures 35A and 35B depict plan views of a device 200 with the removable flangeassembly 225” attached. Figure 35B depicts variation in the width of the flange surface223”; in this case the flange surface 223” is wider at a portion of the device that is placedinferior to the clitoris. As described herein, some embodiments of the invention includeremovable flange assemblies that can have a variety of geometries, curvatures, and configurations.

[188] Figure 36 depicts a perspective view of a removable flange assembly 225”detached from a device body. Figure 36 depicts a removable flange assembly joiningmember 229” integral to the removable flange assembly 225”. The removable flangeassembly joining member 229” couples to the device body and provides a substantiallyairtight seal with the suction chamber to enable operation of the device. Removal of theflange assembly can allow for a user-customized fit. That is, the user can select from arange of removable flange assemblies that have varying dimensions, conf1gurations, materials, coatings, and/or textures as well as combinations of these features.

[189] For example, the width of the sealing flange 223” of the removable flange assembly 225” can be varied from a comparatively narrow width to a comparatively wide _43- width. As another example, the curvature of the sealing flange can be varied from acomparatively steep curvature to a comparatively shallow curvature. Further, a sealingflange on a single removable flange assembly may have a combination of widths andcurvatures on its sealing flange. In still another example, the removable flange assemblycan be made of a combination of materials or from a single material with varyingproperties. For example, the sealing flange can be comparatively softer and more flexible(e. g., 0030A durometer silicone) while the removable flange body can be comparativelymore rigid (e. g., 20A durometer silicone). A comparatively more rigid removable flangebody can help join the immovable flange to the device body. In yet another example, thesealing flange of the removable flange assembly can have a variety of textures or coatings(such as a lubricious or pre-lubricated coating) that potentially improve the comfort, fit, and/or reliability of the seal between the device and tissue.

[190] For examples, Figures 43A-43G show various embodiments of the sealing flangeassembly 225”. Figures 43A-43G show the flange assembly 225” made of a combinationof materials. The sealing flange 225 is a comparatively softer and more flexible materialwhile the flange body 228 that joins to the device body is comparatively more rigid. Thesealing flange portion and flange body portion are mo lded together. In the embodiment ofFigure 43A, the sealing edge 226 has a sharper comer so that as tissue is sucked up intothe suction chamber it makes a tight tum relative to the sealing surface 223” to create a seal at the sealing edge.

[191] For some tissue types and geometries, additional features help to create a sealeither at the sealing edge or along the sealing surface. In the embodiment of Figure 43B,the sealing edge 226 has an additional rib so that as tissue is sucked up into the suctionchamber it makes a tight tum relative to the sealing surface 223” and then as the tissuebecomes engorged into expands out over the additional rib of the sealing edge to create atight seal with the tissue and a mechanical interlock that helps to prevent dislodgement of the device during use.

[192] In the embodiment of Figure 43C, the sealing surface 223” has a protrusion 233running all the way around the sealing surface 223” and a depression 235 running all theway around the sealing surface 223”. The protrusion 233 is very soft and flexible so as to form a close fit over any hair or small differences in folds of tissue that may be traversing _44- the sealing surface 223” to prevent a Suction loss along that hair or tissue. The depression235 provides a space for the hair or tissue as well as provides a location for extralubricant to fill in around or over hair or tissue. In the embodiment of Figure 43D, theprotrusion 233 and depression 235 are combined with the additional rib of the sealing edge 226 of the embodiment of Figure 43B.

[193] The embodiment of Figure 43E-43G has two protrusions 233” and 233”” runningall the way around the sealing surface 223” and one protrusion 233””” that runs onlypartially around the sealing surface 223”. The protrusion 233””” is on the wider flangeportion of the sealing flange 225 which is the portion of the flange that makes contactwith the vulvar tissue inferior to the clitoris. The protrusion 233””” joins up with theprotrusion 233”” to create a continuous seal. The protrusions 233”, 233”” and 233””” arevery soft and flexible so as to forrn a close fit over any hair or small differences in foldsof tissue. The dual and triple conf1gurations provide multiple opportunities to forrn andmaintain a seal along the sealing surface 223” when a suff1cient seal is not maintained along sealing edge 226.

[194] As shown in the bottom view of Figure 43F and top view of Figure 43G, each ofthe embodiments of Figures 43A-43G have multiple suction holes 237 in flangemembrane 227”. Some of the holes 237 are placed toward the perimeter of the suctionchamber in order to facilitate greater sealing at the sealing edge and sealing surface. Thestimulators are integrated into the suction chamber membrane 220 (not shown in Figures43A-43G). The membrane pockets 239 in flange membrane 227” match up andaccommodate the stimulators in the suction chamber membrane 220. The flangemembrane 227” and membrane pockets 239 are thin such that the maximum amount of energy can be transferred from the stimulators through the membrane to the tissue.

[195] In some embodiments, the sealing edge has a wavy texture that provides excessmaterial to conforrn to variations in the tissue surface. The period and amplitude of thewave on the sealing surface will vary with the material chosen for the sealing surface topromote a secure and leak-resistance seal. In general, the sealing flange is made as thin as possible while still maintaining sufficient durability.

[196] In some embodiments, the inferior portion of the sealing edge may be configured with a seam, line or weakness, thinned-out section, or other feature that induces a _45- pinching motion at the tissue interface. A gentle pinching of the soft tissue can close leakpathways in the area where the inferior section of the sealing flange interacts with thelabia minora. Figures 43H, 431, 43J, and 43K depicts a sealing protrusion 221 on thesealing flange 225. The sealing protrusion 221 provides a surface for the labia to sealagainst. More than one sealing protrusion 221 can be used and the sealing protrusion canbe located in other places on the sealing flange 225. The sealing protrusion 221 maycontain a suction port connected with the suction system of the device to promote sealingof tissue against the protrusion. Figures 431, 43J, and 43K depict different cross sections of a sealing protrusion 221.

[197] Without being bound to a specific mechanism or mode of action, the flanges andflange assemblies of certain embodiments can provide one or more of the followingbeneficial properties: (i) smoothing the vaginal tissue undemeath and in the area of theflange; (ii) distributing the engagement forces between the device and the vaginal tissue;(iii) providing physical features that can fit undemeath the labia majora; and/or (iv)increasing the leak path from the suction chamber to the outside environment. Each ofthese beneficial properties can help provide a reliable, comfortable, and customizable anatomical fit.

[198] In certain embodiments, the outer rim portion 220e of the suction chamber 220and/or the inner portion of the sealing flange 223” such as the sealing edge 226 are theprimary part(s) of the device that form the seal with tissue. That is, until the seal betweenthe outer rim portion 220e of the suction chamber and/or the sealing edge/ inner portion ofthe sealing flange 223” is substantially disrupted, the device can maintain a sufficient sealwith tissue. In these embodiments, the sealing flange provides the above beneficialproperties to augment the seal as well as providing a reliable, comfortable, andcustomizable anatomical fit. This can be true for devices with integral flange and sealing edges and devices using a removable flange assembly.

[199] Figures 37A and 37B illustrate a removable flange assembly 225” including aflange membrane 227”. The stimulators are integrated into the suction chambermembrane 220, which remains attached to the device shell. The flange membrane 227”can be formed of the same or different material than the sealing surface 223”. The flange membrane 227” can be relatively taut across the central opening of the removable flange _46- assembly 225” or it may be comparatively looser. The flange membrane 227” may bedomed, planar, or formed to conforrn to the geometry of the device. The flange membrane227” can be stretchable or compliant or comparatively less compliant. The flangemembrane 227” includes one or more perforations or holes. The flange membrane 227”can be formed during the process of forming the removable flange assembly 225”. Forexample, in some embodiments the removable flange assembly 225” is a molded part andthe flange membrane 227” can be molded integrally with the removable flange assembly225” as a comparatively thinner section spanning the interior of the removable flangeassembly 225”. The flange membrane 227” can be molded with holes or perforationsformed during the molding process, or the holes or perforations can be formed after themolding process. The holes or perforations in the membrane may integral to themanufacture of the membrane (that is, the membrane stock material already has holes orperforations). In some embodiments, the flange membrane can be placed in theremovable flange assembly mold and overrnolded into place during the molding processor insert molded. In some embodiments, the flange membrane may be fixed in place afterthe rest of the removable flange assembly has been formed. The flange membrane can beadhered in place using suitable techniques, such as adhesive bonding, heating bondingand the like. The flange membrane can be any type of fabric or sheet material suitable for contacting tissue.

[200] The flange membrane contributes several beneficial properties to the removableflange assembly. For example, the perforations in the flange membrane are sized to allowfor airflow through the membrane while reducing the likelihood of capturing tissue withinthe membrane perforation or allowing tissue to be captured within the suction port of thedevice. The presence of the flange membrane enables larger openings in the motormembrane to assist in cleaning of the device. In another example, the flange membranecan provide further user customization by providing a range of textures for interactionwith tissue. Further, the flange membrane can have a range of perforation sizes and/orpattems that can increase or decrease the suction applied to tissue in concert with the suction mechanism of the device.

[201] Figures 38A illustrates a side elevation view of a removable flange assembly 225”and Figures 38B and 38C depict a side elevation view and a perspective view, respectively, of a cross-section view of a removable flange assembly 225 ”. In these views, _47- the removable flange assembly joining member 229” is depicted as a trough region. Inthis embodiment, this trough region couples to the outer rim of the suction chamber of thedevice body. In other embodiments, the removable flange assembly joining member canbe a projection that fits into a trough region that is located on the device body. Otherconfigurations of the removable flange assembly joining member can be employed as long as these configurations provide a substantially airtight seal with the suction chamber.

[202] The removable flange assembly provides the advantage of improving the ease andreliability of cleaning the entire device. In some embodiments, the removable flangeassembly is formed of materials that allow the removable flange assembly to be cleanedinside a dishwasher while the remaining device body is simply rinsed or otherwisecleaned by hand. In such an embodiment, the tissue-contacting parts of the device can becleaned more thoroughly than if the flange assembly was not removable. Altematively,the removable flange assembly may be single use and disposable. A device may bepackaged with several removable flange assemblies, and these assemblies may beidentical or they may have a variety of different features. Further, a user can purchase more removable flange assemblies for use with the originally purchased device body.

[203] Another benefit of a flange membrane is improved ease and reliability of cleaningthe device body. In embodiments without a flange membrane, the flexible membrane ofthe suction chamber includes ports that are configured and sized to reduce the possibilityof tissue capture and injury. That is, the ports are small and/or offset from tissue. Smalland/or offset ports can be more challenging to clean reliably and thoroughly than largerports or non-offset ports. Further, the ports 220h can be located toward the perimeter ofthe suction chamber 220 as depicted in Figure 39. Such a location for the ports 220h canimprove drainage of fluid from the device body after use or after cleaning when thedevice is placed with the rim of the suction chamber face down on a surface. Typically,there will be at least one hole at the top center of the flange membrane to facilitate tissue engagement with the stimulators.

[204] Referring again to Figure 40, the device body 210 is illustrated to provide a viewof the interior of the device body 210. The vibratory motors 280 are positioned withinstructures in single molded piece 22 such that the stimulation from the motors can be eff1ciently propagated to tissue, and portions of the vibratory motors 280 are also _48- accessible to be connected to controller block 215. In this case, controller block 215 isillustrated as a printed circuit board. An onboard pump 135 is also positioned withindevice body 210. The onboard pump 135 is in fluid communication with the suctionchamber to provide suction within that chamber and is also in fluid communication withan exhaust port. The exhaust port is an outlet for air or fluid pumped out of the suctionchamber and an inlet for air to the suction chamber when suction is reduced. In someembodiments, the onboard pump 135 sends air pumped from the suction chamber acrossheat-generating elements within the device body 210 before reaching the exhaust port.

Such airflow can help dissipate heat and provide safe and reliable use of the device.

[205] In some embodiments, heat generation in the device can be monitored using acomponent such as a therrnistor. Therrnistors can be positioned within the device body210 or be integral to the controller block 215. When the therrnistor detects a thresholdtemperature, it can tum off power to the device and/or vent extemal air into the device to help the cool the device and then release suction.

[206] In some embodiments, the onboard pump is controlled by the controller block viaa closed feedback loop. That is, the controller block is configured to maintain a targetpressure, which can be set by the user or can be loaded as part of a pre-programmedsuction algorithm. To do so, the controller block reads real-time data from an onboardpressure sensor that is configured to monitor pressure (negative pressure in the case ofsuction) within the suction chamber. Based on the real-time data, the controller block canengage the onboard pump to draw more suction within the suction chamber or it canengage a check valve in fluid connection with the exhaust port to vent air into the suctionchamber. In typical operation, after the device has generated sufficient suction to seal it inplace on the user the controller block with periodically engage the onboard pump as suction is slowly lost through leakage.

[207] Figures 41A and 41B illustrate views of a device 200 including a device body210. The sealing flange 225 is coupled to the device body 210. The curvature of thesealing flange 225 provides a comfortable and reliable fit for the anatomy. Further, thefront portion 225f of the sealing flange 225 has narrower profile than the rear section 225rof the sealing flange. This configuration allows device body 210 to ride over the pubic bone of the user while sealing flange 225 is in contact with tissue. The rear section 225r _49- of the sealing flange 225 is comparatively extended to provide a wider sealing surface,similar to that depicted in Figure 35B. The comparatively narrower front section 225f ofthe sealing flange 225 is configured to comfortable and reliably fit at the apex of the labia maj ora.

[208] Figures 41A and 41B also illustrate device body 210 configured to fit comfortablyand reliably on a user in multiple contexts. Specifically, as seen in Figure 41A the rearportion 210r of the device body 210 tapers towards the sealing edge 225 of the device200. This taper can be helpful in allowing partner access during vaginal intercourse. Adevice without such a taper could hinder such access. Further, as seen in Figure 41B therear portion 210r tapers towards a point with respect to the sides of the device 200. Thistaper can be helpful in allowing a user to stand and walk with the device engaged. In adevice without this taper, some users may experience disengagement of the device whenstanding or walking due to contact with the users thighs. Still further, the mechanisms,controller block, batteries, and other intemal components can be positioned towards thefront of the device body 210. Positioning the intemal components in this way can placethe center of mass of the device in such a way that the propensity of the device to fallaway or disengage from the user is decreased. That is, having the center of mass of thedevice farther from the user side of the device, or in some cases towards the rear portion210r of the device body 210, can cause the device to act as a lever and “pry” the device off the user when the user is standing or even when the user is laying down.

[209] Figure 42 illustrates a perspective view of a device 2400 that includes a devicebody 2410, a sealing flange 2425, and an onboard manual pump 2435. Onboard manualpump 2435 is in fluid connection with the suction chamber of the device. The pump 2435is depicted as a bellows-style pump in which the user pushes down on the exterior surfaceand thereby expels air from a pumping chamber through an exhaust port. The pumpingchamber is in fluid communication with the suction chamber via one or more valves thatallow suction to be pulled from within the chamber but prevent air from entering thepumping chamber when air is being expelled from the pumping chamber. Other manualpumps, like bulb systems (similar to a blood pressure cuff) or plunger systems are, maybe used. The onboard manual pump can be locked in a low profile state when the pump is not being activated. _50-

[210] Certain embodiments of the invention include device and methods to enhancefemale sexual Wellness and female sexual pleasure and some methods are for treatment offemale sexual dysfunction. Certain embodiments of the invention include device andmethods to treat (i) female sexual arousal disorder, (ii) hypoactive sexual desire disorder,and/or (iii) female orgasmic disorder. The methods naturally enhance a Woman”s ownsexual response Without undesirable, lasting side-effects. A Woman Will enjoy sexual intimacy again and feel conf1dent in her body°s ability to respond to sexual stimulation.

[211] In embodiments described herein, coin-style vibrating motors can be placed edge-on to tissue, in a planar configuration against tissue, or at an angle With respect to tissuetherebetween. The angle With respect to tissue can provide a varying degree of intensity.In some embodiments, the device is configured such that the motor angle can be adjustedby the user directly (as in manually) or indirectly by selecting certain stimulation pattems from the controller.

[212] Figure 45A illustrates an embodiment in Which a body vibration source 211 (suchas a vibration motor) on the device body 210 provides a baseline level of vibratorystimulation. The vibration on the device body 210 could be, as described in more detailbelow, the result of contacting the device body 210 With a conventional vibrator.Altematively, a body vibration source 211 can be included on the device body 210 inaddition to any of the stimulating elements described herein as delivering stimulation tovaginal tissue Within a tissue chamber (or a suction chamber). Advantageously, the bodyvibration source 211 provides a level of stimulation that serves to effectively amplify thestimulation provided in the tissue chamber. That is, a baseline level of vibration cancontribute to the engorgement and arousal process, and the stimulating elementsintegrated With the tissue chamber further advance the engorgement and arousal process.Further, the intemal vibrating motors can be used initially for arousal and then the bodyvibration source may be used as additional vibration for additional sensation and/or forattainment of climax. Still further, the baseline vibration from the body vibration source211 cooperates With vibratory motors to produce resonant and/or harrnonic vibrationpattems With tissue. Certain users may prefer labial stimulation in conjunction Withclitoral stimulation, and the body vibration source 211 can provide vibratory labial stimulation. _51-

[213] In related embodiments illustrated in Figure 45B, multiple body vibration source211a and 211b can be positioned on the device body 210. When multiple motors arepositioned on the device body 210, the multiple body vibration source 21 la and 211b canbe configured to vibrate at various frequencies, creating various vibration prof1les. Thevibration prof1les can be in phase, out of phase, di-phasic (creating di-phasic amplification), or multi-phasic.

[214] Figure 46 illustrates an embodiment of the device and method, in Which one ormore stimulation sources (such as vibratory motors) 180a, 180b, 180c, and 180d arecontained Within a stimulation chamber 182 and the stimulation chamber 182 ispositioned Within the device such that it can contact vaginal tissue and the clitoris inparticular. The stimulation sources 180a, 180b, 180c, and 180d are free to stimulateand/or vibrate Within the stimulation chamber 182 and in this Way periodically applyvibratory stimulation to a bottom surface 183 of the stimulation chamber 182 that isconnected to the suction chamber 120. The stimulation sources 180a, 180b, 180c, and180d may be connected by Wires to a control block, but are other Wise free to moveWithin the stimulation chamber 182. In some embodiments, the control signals areWireless. Further, the motors may be powered and/or charged by RF signals so that theyneed not be tethered by Wires. In this case, the stimulation sources 180a, 180b, 180c, and180d are entirely free to move Within the vibratory chamber. One feature of theseembodiments is that the stimulation sources 180a, 180b, 180c, and 180d are notsuspended Within the suction chamber 120 but rather periodically impinge upon the suction chamber 120.

[215] Figures 47A, 47B and 47C illustrate embodiments in Which stimulating features485 can be made to impinge upon the tissue chamber. Figures 47A-47C operate in amanner similar to the embodiments disclosed in Figure 10. For example, an array ofstimulating features 485 can be positioned above the tissue chamber and the array can berotated or otherwise moved With respect to tissue. In some embodiments, such as depictedin Figure 47C, another displacing element 486 can be positioned above the array ofstimulating features 485 and the movement of the displacing element 486 forcesindividual or groups of stimulating features 485 in the array to impinge upon the tissuechamber. The displacing element 486 and the stimulating features 485 can be permanent magnets or electromagnets such that the displacing element 486 generates movement in _52- the stimulating features 485 by magnetic opposition. In embodiments in which thestimulating features 485 are perrnanent magnets or electromagnets, the stimulatingfeatures 485 can be positioned in a holding tray or embedded in a membrane to keep theelements apart. Without such a holding tray or membrane, the magnetic attraction amongthe stimulating features 485 could cause them to bind together and prevent the desiredmovement. Figure 47D illustrates an embodiment in which an array of displacingelements 486 is positioned above an array of stimulating features 485. The array ofdisplacing elements 486 is selectively addressable to create pattems of stimulation by forcing the stimulating features 485 to impinge upon the tissue chamber 220.

[216] In many of the embodiments described herein, it is advantageous to minimize thenumber or moving parts. It is also advantageous to minimize the number of relativelyexpensive parts. The embodiments that use an array of stimulating elements that are insome way driven by comparatively fewer motors, magnets, or other energy sources achieve the advantages or fewer moving parts and/or fewer expensive parts.

[217] In another embodiment illustrated in Figures 48A, 48B, and 48C, a vibratorysource includes a vibrating stylus 3250 connected to a motor 3220. The stylus 3250 ispositioned within a translating frame 3200 that enables the stylus 3250 to be translatedrapidly to different positions with respect to the tissue within the tissue chamber (orsuction chamber). In a preferred embodiment, the translating frame 3200 is configuredsuch that the stylus 3250 recenters within the frame when translating forces are removed.For example, the stylus 3250 can be connected using elastic members 3330 toelectromagnets 3340. The motor housing 3220 can include a perrnanent magnet or anelectromagnet, which is actively translated by fields generated by the electromagnets inthe translating frame. The motor housing 3220 can, altematively, be moved by a pulleytype system between movable fixtures on the translating frame. The motor connected tothe stylus 3250 can be vibrationally isolated from the stylus 3250 and translating frame3200 by mounted the motor on a dampening structure, such as a foam. More than onestylus 3250 and/or more than one translating frame 3200 can be used in variousembodiments described herein. In some embodiments, the stylus 3250 can be used toforce stimulating features 485 in an array 48, such as that depicted in Figure 48C, toimpinge upon tissue as further described in other embodiments herein. Figure 48A further depict an embodiment in which the stylus 3250 is translated via the interaction of a _53- magnet 3255 positioned on the stylus arm. Electromagnets 3253 and 3257 are used totranslate the stylus 3250 and motor 3220 vibrates the stylus 3250. [2l8] In embodiments of the device and method illustrated in Figures 49A and 49B, amotor 3580 located outside the suction chamber 3590 is connected to or otherwisecommunicates vibration to a link 3530 mounted at least partially within the suctionchamber 3590. The link 3530 interacts directly or indirectly with tissue within the suctionchamber via a stimulating feature 3520. For example, the link 3530 may directlystimulate tissue by being in contact with the tissue, or the link 3530 may indirectlystimulate tissue by communicating vibration to a stimulating member (such as the array487 depicted in Figure 48C or depicted in Figure 49C) that is in contact with tissue. Thestimulating member 3520, such as that depicted in Figure 49C, may have one or moreprojections 3572 that stimulate tissue directly. The projections 3572 may have a varietyof stiffr1esses such that they produced a variable stimulating profile. For example, someprojections 3572 may be comparatively flexible and others may be comparatively stiff The stiff proj ections transmit comparatively more vibration than the flexible proj ections.

[219] In some embodiments, the suction chamber includes end effectors that are coupledto and driven by a motor on the outside of the suction chamber. As depicted in aschematic view in Figure 50A, one or more end effectors 3630 can be selectivelyaddressed by one or more motors 3680. That is, an individual motor 3680 can move orvibrate one or more end effectors 3630 as directed by a controller. Further, the controllercan direct the individual motor 3680 to move or vibrate just one end effector 3630 ormultiple end effectors. If the individual motor 3680 is directed to move or vibratemultiple end effectors 3630, the motor 3680 can be further directed as to the sequence inwhich the multiple end effectors 3630 are moved or vibrated. Figure 50B illustrates acoupler 3650 positioned between each motor 3680 and certain end effectors 3630 tofacilitate the selective transmission of motion or vibration from the motor 3680 thedesired end effector or effectors 3630. A variety of methods, including magnetic couplingand mechanical coupling, can be used by the coupler to selectively transmit motion orvibration. For example, the end effectors 3630 can be coupled by selectively activatingand electromagnet to draw in and connect a permanent magnet on the near end of an endeffector 3630 to the coupler 3650. Then, reversing the polarity of the electromagnet can decouple the end effector 3630 and retum it to its original position. In another example _54- depicted in Figure 50C, one of an array of grippers 5655 can grip the near end of given anend effector 3630 to enable transmission of motion or vibration and be released to stopthe transmission of motion or vibration. As With other embodiments described herein, the end effector 3630 can be translated in the in two dimensions as depicted in Figure 50D.

[220] Advantageously, in some embodiments multiple motors can be arranged in alayered configuration With connecting rods of varied lengths. This is an advantagebecause multiple motors can be arrayed in a comparatively small space and transmitvibration to a larger vibration member. Such an arrangement can also be combined With astimulator, such as a vibratory motor, suspended Within the suction chamber.Altematively, the multiple motors can be layered and/or configured such that theytransmit vibration to at a comparatively higher resolution. That is, the motors cancommunicate via rods, for example, to a vibratory element Whose footprint iscomparatively smaller than the footprint of the motor configuration. Further, the vibratoryelement can have a high density of the stimulating elements that are individually or multiply addressable by the motors.

[221] In contrast to some prior art devices, these embodiments directly interact With astimulating member having an array of projections. That is, some prior art devices simplyshake an entire array of projections rather than providing a series of transmission point that eff1ciently transmit vibration from a motor to discrete parts of a stimulating array.

[222] In some embodiments, the motor or motors can be located remotely from thestimulating and/or suction chamber such that the motors are contained in a separatehousing. The motors can transmit vibration to the site of stimulation via a cable or rodassembly or other similar member. The motor housing can be mounted on a garrnent orother Wearable item. Or, the motor housing can be placed nearby the user Without actually being Wom or held by the user.

[223] Figures 51A and 51B illustrate an embodiment in Which a single motor 4050 candrive a stimulation-coupling element 4000, Which has areas of differing rigidity. Rigidareas of the stimulation-coupling element 4000 can vibrate harrnonically or resonantlyWith the motor 4050. Thus, a single motor 4050 can drive spatially differentiated vibratory stimulation. _55-

[224] The stimulation-coupling element 4000 can be a network of comparatively rigidnodes 4010 connected by comparatively rigid spokes 4020. The stimulation-couplingelement 4000 can also have less rigid regions 4030 that help isolate the vibration to thenodes. That is, the presence of less rigid regions 4030 serves to help spatially differentiate the areas that are vibrating in resonance or harrnony With the drive motor 4050.

[225] Altemately, the nodes 4010 can include passive actuators that can couple With thedrive motor to provide spatially differentiated stimulation. A passive actuator can includepiston and cylinder configuration that stores energy, such as via a spring or its equivalent,and the stored energy can be released and reloaded through resonant coupling of the node4010 to the drive motor 4050. In some embodiments, passive actuators at nodes 4010 canbe selectively controlled by activating or deactivating local dampers. For example,passive actuators have selectively addressable locking mechanisms. Such mechanismscan be electronically controlled by the device controller block that provides pattems forspatially differentiated stimulation. Micro-Electro-Mechanical Systems (MEMS)technology provides various routes for local, selectively addressable control of active and passive actuators and can be implemented in the embodiments described herein.

[226] Devices described herein are advantageously attached securely and comfortable toa user°s body. In some embodiments, the tissue chamber is configured to fit under thelabia majora such that the device is Wearable Without any other attachment mechanisms(although suction is an optional attachment mechanism). In some embodiments,additional features on the device provide additional Ways of comfortably securing thedevice. For example, adhesives (such as gummy, sticky, or otherwise tacky materials) canbe applied to the tissue flange on the device. Still further, flexible Wings 294, as depictedin Figure 52C, can be detachably present on the device body 210 (as seen from thebottom), and the Wings 294 can be configured as pressure-sensitive, temperature-sensitive, or moisture-sensitive surfaces. A device 200 can be supplied to a user Withmultiple attachable and disposable adhesive Wings 294. For many users, it is preferable toapply adhesive to an area superior to the clitoris, such as the clitoral hood, Where the tissue is more skin than mucosa.

[227] Another method for providing secure and comfortable attachment is through theuse of lateral projections 292 on the sides of the device 200 as depicted in Figure 52A in _56- cross-section. Such lateral projections 292 complement the tissue flange 225 that extendsbelow the labia majora. The lateral projections 292 can be resilient and flexible tofacilitate placement. Further, the lateral proj ections 292 can be configured to bend or snapinto place after placement of the tissue flange 225 under the labia majora. The lateralprojections 292 can be configured to transmit vibration to the labia majora for usersinterested in such supplemental stimulation. Altemately, the device can include soft clips for attaching the device to the labia maj ora.

[228] Still another method for providing secure and comfortable attachment is throughthe use of soft and comparatively compliant extensions 293 attached to the inferiorportion of the device 200, as depicted in Figures 52B (as seen from below) and 52D (anisometric view). These inferior extensions 293 are configured to extend under the labialfold and press laterally to stabilize the device 200. The extensions 293 can be resilientand flexible so that they can be pinched together during device positioning and allowed to spring back open and provide gentle support for the device.

[229] In some embodiments, the system 4100 includes an intravaginal unit 4160coupled to a clitoral stimulation device 4110. The intravaginal unit 4160 can deliverstimulation, including all the types of stimulation disclosed herein. Additionally oraltematively, the intravaginal unit 4160 can house any of the components of the systemdisclosed herein. Altematively, intravaginal unit 460 can be passive and act as a unit toprovide additional compression/stabilization of the clitoral stimulation device 4110. Forexample, in some embodiments the intravaginal unit 4160 includes a motor that iscoupled to stimulating elements within the clitoral stimulation device 4110. The motorcan be configured to provide both intravaginal vibration and clitoral stimulation bytransmitting vibration through the stimulating elements. A transmission element, such asa cable, connects the motor in the intravaginal unit 4160 with the clitoral stimulationdevice 4110. The intravaginal unit 4160 can be configured to engage and stimulate erogenous zone(s) on the anterior vaginal wall (the “G-spot”).

[230] The coupling between the intravaginal unit 4160 and the clitoral stimulationdevice can be a “C” shaped connecter 4150, which is configured to provide a secure andcomfortable fit. For example, the connector 4150 could be reversibly deformable or it could be capable of flexing open and closed to retum to an original position. The _57- connector 4150 can be formed from a resilient or malleable Wire encased in a protectivecover. The connector can have a hinge point 4155 to facilitate placement. Theintravaginal unit 4160 can be configured to vibrate or otherwise stimulate the G-spot via astimulation source (such as a motor) located near Where the unit 4160 meets theconnector 4150. In another aspect, the stimulator for the intravaginal unit 4160 can be located in the housing of the clitoral stimulation device 4110.

[231] In some embodiments, the intravaginal unit is not physically connected to theclitoral stimulation device. In such embodiments, the intravaginal unit can communicateby near-field radiofrequency technology or other interdevice communication methods. Insuch embodiments in Which the intravaginal unit is not physically connected to theclitoral stimulation device, the intravaginal unit can still provide vibratory of other stimulation by virtue of stimulation elements included in the intravaginal unit.

[232] An intravaginal unit can be used to provide clitoral stimulation by vibrating orresonating With a comparatively small device applied to the clitoris. Advantageously,such embodiments can use a soft clip or similar device applied to the clitoris, and the softclip can be driven to provide stimulation by the intravaginal unit. In one embodiment, thesoft clip contains permanent or electromagnets that can be driven to squeeze together andcome apart to provide stimulation to clitoral tissue. An intravaginal unit or a separate unit can provide the extemal magnetic field used to drive the soft clip.

[233] Other embodiments of the device, depicted in Figures 54A, 54B, 54C, and 54D,place some or all of the stimulators inferior to the clitoris. The body 4510 of the device4500 in these embodiments is placed in the space between the labia such that the center ofmass of the device is farther inferior than other embodiments described herein in Which asignificant portion of the device rests on the mons. One advantage of this embodiment isthat the Weight of the device is someWhat inferior to the clitoris and therefore can providesecure and comfortable attachment. The device may partially obstruct the urethra and/orthe vaginal opening. The device can be configured to take advantage of its location andemploy any of the intravaginal unit embodiments described herein. Another advantage ofthis embodiment is that the stimulators 4580 can directly contact the clitoris Withoutrelying on clitoral engorgement. That is, by placing the motors inferior to the clitoris, the motors contact the clitoris While it is in a comparatively flaccid state. Figures 54A, 54B, _53- and 54C illustrate a front view, a perspective view, and a side cross-sectional view, respectively, of the clitoral engagement Chamber 4550.

[234] In certain embodiments, the suction chamber is flexible and/or capable ofexpanding. The suction chamber is brought into contact With clitoral and/or vulvar tissue.When suction is applied, tissue is captured and the flexible suction chamber displaces andoptionally expands to fiarther capture tissue and to present tissue to stimulating elements,such as vibratory motors. In these embodiments, the vibratory motors can be locatedoutside the suction chamber, as opposed to being suspended With the suction chamber.Further, clitoral and/or vulvar tissue may be gently squeezed towards the stimulatingelements in addition to, or instead of, being draWn by suction towards the stimulatingelements. Squeezing tissue can be accomplished using a variety of methods. For example,the Walls of the suction chamber can be plastically deformable such that a user canmanually manipulate the chamber to squeeze tissue. In another example, the suctionchamber Walls can be biased to squeeze together and the user can manually separate them during placement on clitoral and/or vulvar tissue.

[235] In some embodiments, electromagnetic actuators that are conf1gured differentlythan a conventional voice coil are used. For example, planar magnetic transducers can beused as actuators to deliver stimulation to clitoral and/or vulvar tissue. Planar magnetictransducers can provide direct mechanical stimulation via a diaphragm or membrane thatdirectly contacts tissue, or they can provide acousto-mechanical stimulation that drives air against clitoral and/or vulvar tissue.

[236] Planar magnetic transducers typically consist of a diaphragm having a printedcircuit spread across the surface of a thin-film substrate and a magnetic array. Themagnetic array creates a magnetic field parallel to the diaphragm. The thin diaphragm ishighly responsive to electrical signals and can be used to generate spatially differentiated kinesthetic sensations and forces.

[237] In other embodiments, magnets can be embedded in a thin membrane that ispositioned and conf1gured to stimulate clitoral and/or vulvar tissue. An electromagneticarray can be positioned above the membrane to drive specific magnets and createspatially differentiated stimulation. That is, selective activation of the electromagnetic array can drive individual or groups of embedded magnets. Altematively, instead of an _59- electromagnetic array, one or more moveable perrnanent magnets can be used toselectively drive individual or groups of embedded magnets. The perrnanent magnet canbe moved by a variety of mechanical or electromechanical means and according to various programmable or pre-programmed pattems.

[238] In certain embodiments, the system includes a vacuum reservoir. That is, thesystem includes a chamber that is capable of holding negative pressure that can beapplied to the suction chamber of the device through a valve system. During initialattachment, after achieving the desired level of suction in the suction chamber, such asWith an on-board pump, the vacuum source continues to run to supply the vacuumreservoir With excess negative pressure. The on-board pump can stop running, and if asmall leak develops the negative pressure in the vacuum reservoir can supply suction tothe suction chamber until it is exhausted, and then the pump can tum back on to replenishthe reservoir and suction chamber and then stop running again. One advantage of thevacuum reservoir is that the desired level of suction can be maintained While having the suction source operate comparatively less than a system Without a vacuum reservoir.

[239] Systems described herein can be equipped With sensors and sensing capabilities.The data collected from sensing can be used in a variety of Ways, such as display to theuser and/or feedback to the device control systems. Sensed parameters include tissuetemperature, tissue impedance, blood flow, tissue turgidity and/or engorgement, heartrate, and blood pressure. The data can be represented on the user control device, such as asmartphone. The data can be represented graphically and/or numerically and can bemapped over a visual representation of the anatomy. In a sense, the displayed data can bean “arousal meter” that provides information to the user. Further, the state of the user”sarousal can be used to provide a biofeedback loop to control the device. For example, theuser can set an arousal level on the device prior to use and the device can monitor theuser°s arousal state. By sensing the arousal state, the device control systems can increase or decrease stimulation to meet the user-set state.

[240] In some embodiments, actuators are used rather than coin-style or other vibratorymotors. One style of actuator is a linear actuator in Which a member is driven back andforth. The electromagnetic voice coils described herein are an example of a type of linear actuator Wherein a membrane is driven in response to an electromagnetic coil. Other _60- linear actuators involve electromagnets and passive magnets arranged in a piston-type configuration to create linear motion. [24l] In certain embodiments, the linear actuators used are not driven solely, or at all,by electromagnetic fields. For example, pneumatic actuators can be used in Which areservoir is charged With compressed gas (including air) by a pump. The pump can be amanual pump such as a belloWs or a syringe pump. The linear drive element of thepneumatic actuator can be biased in a first position and driven to a second position by aburst of gas released from the reservoir through a valve system. Other configurations of pneumatic actuators are useful in these embodiments.

[242] In certain embodiments, miniature scale actuators of other types are used togenerate stimulating forces. For example, various types of therrnomechanical andtherrnoelectric actuators can be used to drive stimulating elements in a device. Suchactuators include those that use therrnoelectricity to expand a fluid, and such fluidexpansion can drive a mechanical element (a piston, for example). Other therrnoelectricactuators that are useful in some embodiments include shape memory alloys, such asnitinol, Which can be used to produce mechanical motion When therrnoelectrically heated.More generally, actuators capable of producing kinesthetic forces and sensations, including each of the types of actuators disclosed herein, are applicable as stimulators.

[243] In some embodiments, pneumatic systems can be used to provide stimulation.Pneumatic systems having miniature ports can deliver rapid puffs of air (or other gas) toproduce tactile and/or kinesthetic sensations and forces. The rate and volume of the puffsof air can be varied to produce a variety of stimuli. Multiple ports for delivery of puffs ofair can be used to achieve spatially differentiated stimulation of clitoral and/or vulvartissue. Multiple ports can be configured using a valve and port array that delivers air from one or more pneumatic sources. Altemately, an array of pneumatic sources can be used.

[244] In some embodiments, circulating air can be used to provide stimulation. As Withthe pulsed or puffs of air, a pneumatic source or sources can deliver air through a valveand port system. In contrast to the pulsed air system, a circulating air system can be usedto stimulate tissue by bloWing across tissue rather than pulsing against tissue. Certainembodiments employ both types of pneumatic systems in Which air is circulated and pulsed. Further, pulsed air may also be directed across the surface of tissue. And, _61- pneumatic stimulators can be used on conjunction With any of the other stimulator types disclosed herein.

[245] Referring still to systems including multiple valve and ports, in someembodiments a suction source is used to apply suction through a valve and port array.Such a system can engage clitoral and/or vulvar tissue at multiple, spatially differentiatedlocations. Altemately, multiple and separately controlled suction sources can be used inconjunction With, or in place of, an array of valves and ports. In some embodiments, rapid fluctuation of suction can be used to produce kinesthetic sensations and forces.

[246] In many of the embodiments described herein, it can be desirable to applytherapeutic energy to clitoral and/or vulvar tissue, such as light energy or electromagneticenergy. Certain light frequencies can decrease tissue inflammation and certain light frequencies can increase local blood flow.

[247] In many of the embodiment described herein, it can be desirable to provideambient sounds via the device or system. Ambient sounds can be soundscapes thatpromote feelings of Well-being and/or arousal in the user. Additionally, the ambientsound can be a “White noise” that provides a relatively constant background sound andthereby masks or de-emphasizes sounds made by the device during device operation. To that end, the device or system could include an active noise cancellation system.

[248] While the invention has been described With reference to certain embodiments, itWill be understood by those skilled in the art that various changes may be made andequivalents may be substituted Without departing from the scope of the invention. Inaddition, many modifications may be made to adapt a particular situation or material tothe teachings of the invention Without departing from its scope. Therefore, it is intendedthat the invention not be limited to the particular embodiment disclosed, but that the invention Will include all embodiments falling Within the scope of the appended claims. _62-

Claims (15)

1. An apparatus for promoting sexual arousal in a female user, including:a tissue-contacting chamber including a suction chamber, and at least twostimulators flexibly suspended at least partially within the suction chamber; and a membrane at least partially encapsulating at least one of the stimulators.

2. Apparatus as claimed in claim 1 including a suction adjustment element, wherein the suction adjustment is in fluid communication with the tissue-contacting chamber.

3. Apparatus as claimed in claim 1 wherein parameters of the stimulators arecontrolled and the parameters are selected from the group consisting of Vibrationalfrequency, Vibrational intensity, Vibrational duration, sequence of motor Vibration, and combinations thereof

4. Apparatus as claimed in claim 3 wherein the stimulators are controlled byselecting from a pre-programmed algorithm, a user-customizable algorithm, or combinations thereof

5. Apparatus as claimed in claim 1 including a wearable device body with anattachment area that fits between the labia majora inferior to the clitoris and a housingthat exits the labia majora superior to the clitoris, the attachment area having a length and the housing a height that allow intercourse.

6. Apparatus as claimed in claim 1 wherein the stimulators are miniature coin stylemotors.

7. Apparatus as claimed in claim 6 wherein the miniature coin style motors are encapsulated in a convex shape membrane. _63-

8. Apparatus as c1aimed in c1aim 1 including a suction-generating device and aWearable device body, Wherein the suction-generating device is detachab1e from the Wearab1e device body.

9. Apparatus as c1aimed in c1aim 8 Wherein the stimu1ators remain substantia11y in contact With tissue after the suction-generating device is detached.

10. Apparatus as c1aimed in c1aim 1 Wherein the membrane is coup1ed to the chamber.

11. Apparatus as c1aimed in c1aim 10 Wherein the stimulators are flexibly suspended via the membrane.

12. Apparatus as c1aimed in c1aim 1 Wherein the membrane is configured to be disp1aceab1e by the user°s c1itoris.

13. Apparatus as c1aimed in c1aim 1 Wherein the stimulators are contro11ed such that the user experiences simu1ated macroscopic motion.

14. Apparatus as c1aimed in c1aim 1 Wherein vibration generated by one stimulator is iso 1ated from a Wa11 of the tissue-contacting chamber.

15. The apparatus of c1aim 1 Wherein the stimulators are motor type stimulators and are individua11y contro11ed. _64-