Note: Descriptions are shown in the official language in which they were submitted.
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DEVICES AND METHODS FOR PROMOTING FEMALE SEXUAL WELLNESS
FIELD OF THE INVENTION
[01] Embodiments of the present invention relate generally to devices and
methods and
more particularly to promoting female sexual wellness and function. In
particular, certain
embodiments 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 arterial
vasodilation within the clitoris. The resultant increase in blood flow leads
to tumescence
of the glans clitoris and increased sexual arousal. A variety of conditions
may cause
clitoral erectile insufficiency and reduced clitoral arterial flow. This, in
turn, may lead to
difficulty or inability to achieve clitoral tumescence. Female sexual wellness
may also be
negatively affected by a lack of subjective excitement, genital lubrication or
orgasmic
function.
[03] The incidence of symptoms ranging from dissatisfaction to dysfunction is
high in
women. For example, in the National Health and Social Life Survey of 1,749
women age
18-59, 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 women
experience sexual dissatisfaction or "problems" (not dysfunctional in nature).
In a
national survey of more than 31,000 women in the United States, 44.2 % of
women
reported experiencing a sexual problem. According to other studies, over 53
million
women (43% of the U.S. population) have reported one or more sexual problems
and
over 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: a
critical 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 study
of 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,
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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 States
Prevalance and Predictors. JAMA, 1, 281: 537-544; Read S, King M, Watson J.
Sexual
dysfunction in primary medical care: prevalence, characteristics and detection
by the
general 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
problems
among family practice patients. Fain Pract Res J. 1988;7:122-34; Shifren JL,
Monz BU,
Russo PA, Segreti A, Johannes CB. Sexual problems and distress in United
States
women: prevalence and correlates. Obstet Gynecol. 2008;112(5):970-978; and
Shifren,
Obstet Gynecol 2008; 112: 970-8.)
[04] Research indicates that a sufficient blood supply is required for good
clitoral and
vaginal function and satisfying sexual experience at any age. Women at risk
for Female
Sexual Dysfunction include those using birth control pills, those with poor
vascular health
(such as those with diabetes, high cholesterol, or hypertension), aging women
and those
undergoing or having undergone cancer radiation treatment (which may adversely
decrease lubrication, hormone levels, and/or genital sensation). Using birth
control pills
can lower the circulating levels of testosterone needed to regulate blood flow
to genitals
and stimulate sexual desire and can cause long-term permanent sex hormone
insufficiency. 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
anatomical
difference makes females more susceptible to inhibitors. While the glans penis
in men
and the glans clitoris in women similarly each have the highest concentration
of sensory
receptors than any other location in the body, the male anatomy provides more
extensive
structural support for the glans penis. Addressing male sexual dysfunction can
take
advantage of this structural support by augmenting or enhancing the venous
trapping
function of the corpus cavemosum. In contrast, no anatomical sustain mechanism
exists
in women for engorgement making women more susceptible to an array of powerful
inhibitors. While the female corpus canvernosum does become engorged during
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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 of
sufficient sexual stimulation. For example, Figure 30 illustrates how sensory
and
psychosocial factors, such as the well-being of the woman's relationship with
her partner
and emotional or visual cues, drive central nervous system (CNS) mediated
promotion or
inhibition (denoted by the +/- symbol). Other health factors such as diabetes
or
cardiovascular 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
sexual
experience (SSE) for women. The cycle includes the states of (i) emotional and
physical
satisfaction, leading to (ii) emotional intimacy, leading to (iii) being
receptive to sexual
stimuli, leading to (iv) sexual arousal, leading to (v) arousal and sexual
desire, which
takes 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
method
for promoting female sexual arousal; for clitoral engorgement using suction
combined
with vibratory stimulation; for providing variable and customizable control of
vibration
and suction; for providing a novel power-tissue optimization scheme based on
stimulators
mounted on a flexible membrane; for providing a novel suction attachment
modality
combined with multi-focal actuators; and for providing novel actuators for
mechanical
motion and suction.
[10] Certain embodiments of the present invention are related to a system, or
a method
for providing a tissue-contacting chamber and at least two stimulators coupled
to the
chamber and controlled such that the user experiences spatially differentiated
stimulation.
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The system can include a suction port in fluid communication with an interior
of the
tissue-contacting chamber. The system can include a suction adjustment
mechanism
integral to the tissue-contacting chamber. The system can include a plunger
positioned
within the interior of the tissue-contacting chamber and configured to adjust
suction
within the tissue-contacting chamber. The system can include a sealing surface
attached
to the tissue-contacting chamber and configured to maintain a substantially
airtight seal
against tissue. The system can include a controller and/or remote controller.
The system
can include that parameters of the stimulators are controlled and the
parameters are
selected from the group consisting of vibrational frequency, vibrational
intensity,
vibrational duration, sequence of motor vibration, and combinations thereof
The system
can include that the stimulators are controlled by selecting from a pre-
programmed
algorithm, a user-customizable algorithm, or combinations thereof The system
can
include a suction-generating device and a wearable device body, wherein the
suction-
generating device is detachable from the wearable device body. The system can
include
that the device body remains substantially in contact with tissue after the
suction-
generating device is detached. The system can include a membrane at least
partially
encapsulating at least one of the stimulators. The system can include that the
membrane is
coupled to the chamber. The system can include that the membrane is configured
to be
displaceable by the user's clitoris. The system can include that the
stimulators are
controlled such that the user experiences simulated macroscopic motion. The
system can
include that the stimulators generate macroscopic motion while contacting
tissue. The
system can include that vibration generated by one stimulator is isolated from
vibration
created by another stimulator. The system can include that vibration generated
by one
stimulator is isolated from a wall of the tissue-contacting chamber. The
system can
include that at least one of the stimulators are held in direct contact with
the user's clitoris
during an application of suction.
[11] Certain embodiments of the present invention are related to a system, or
a method
for 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 system
can include that the housing is configured to be wearable. The system can
include that the
stimulators are configured to provide multivariate stimulation. The system can
include
that the stimulators are configured to provide a combination of macroscopic
motion and
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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 method
for providing a tissue-contacting chamber including a suction chamber, the
suction
chamber being in fluid connection with a programmable suction pump, and at
least two
stimulators mounted within the suction chamber, wherein the motors and the
suction
pump are configured to be independently controllable via a control circuit.
The system
can include a controller block that includes pre-loaded vibration patterns and
pre-loaded
suction patterns. The system can include that the controller block is
configured to allow a
user to create vibration patterns and suction patterns. The system can include
a wearable
device body and a suction pump is mounted within the device body. The system
can
include that the controller block is configured to enable the user to set a
first suction level
and a second suction level. The system can include that the controller block
is configured
to enable the user to set a rate at which the suction pump alternates 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.
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[20] Figure 5A illustrates a perspective view of the interior of a chamber
portion and
associated stimulators of a device according to an embodiment of the
invention.
[21] Figure 5B illustrates a perspective view of the exterior of a chamber
portion and
associated stimulators of a device according to an embodiment of the
invention.
[22] Figure 6 illustrates stimulators and vibration isolators of a device
according to an
embodiment of the invention.
[23] Figure 7 illustrates a wearable garment and a device according to an
embodiment
of the invention.
[24] Figures 8A through 8C illustrate various views of a device according to
an
embodiment of the invention.
[25] Figures 8A' through 8C' illustrate various views of a device according to
an
embodiment of the invention.
[26] Figure 9 illustrates a portion of a device configured to provide
macroscopic
motion according to an embodiment of the invention.
[27] Figure 10 illustrates a portion of a device configured to provide
macroscopic
motion according to another embodiment of the invention.
[28] Figure 11 illustrates a device configured to provide macroscopic motion
according
to an embodiment of the invention.
[29] Figure 12 illustrates a perspective view of a device according to another
embodiment of the invention.
[30] Figure 13 illustrates a cross-sectional view of a device according to
another
embodiment of the invention.
[31] Figures 14A and 14B illustrate views of a device and assembly of such a
device
according to another embodiment of the invention.
[32] Figures 15A and 15B illustrate views of a device according to another
embodiment of the invention.
[33] Figure 16 illustrates a view of a device according to another embodiment
of the
invention.
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[34] Figure 17 illustrates a view of a device according to another embodiment
of the
invention.
[35] Figure 18A and 18B illustrate perspective views of a device and a
detachable
suction element according to another embodiment of the invention.
[36] Figure 19 illustrates a cross-sectional view of a device according to
another
embodiment of the invention.
[37] Figure 20 illustrates a cross-sectional view of a device and a
perspective view of a
controller according to another embodiment of the invention.
[38] Figures 21 and 22 illustrate stimulator and lever arrangements according
to
embodiments of the invention.
[39] Figures 23A and 23B illustrate a device providing macroscopic motion
according
to an embodiment of the invention.
[40] Figures 24A through 24D illustrate various views of a device according to
an
embodiment of the invention.
[41] Figures 25A and 25B illustrate a charging station and device according to
an
embodiment of the invention.
[42] Figure 25C illustrates a charging station and device according to another
embodiment of the invention.
[43] Figures 26A and 26B illustrate views of a device and a controller
according to an
embodiment of the invention.
[44] Figures 27A and 27B illustrate views of a device according to an
embodiment of
the invention.
[45] Figure 28 illustrates a view of a device according to an embodiment of
the
invention.
[46] Figure 29 illustrates a view of certain elements of the human female
anatomy
relevant to embodiments of the invention.
[47] Figure 30 is a flowchart illustrating multiple inhibitors and promoters
of a
satisfying sexual experience and their interdependence.
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[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.
[57] 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 configured 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
manual
pump.
[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.
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=
[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 system 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 5IA 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 the
same meaning as commonly understood by one of ordinary skill in the art to
which this
invention belongs. Although any methods and materials similar or equivalent to
those
described herein can be used in the practice or testing of the present
invention, the
preferred methods and materials are now described.
[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, and
examples. Any interpretation of the terms in this description should take into
account the
full description, figures, and examples presented herein.
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[76] The singular terms "a," "an," and "the" include plural referents unless
the context
clearly dictates otherwise. Thus, for example, reference to an object can
include multiple
objects 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
considerable
degree or extent. When used in conjunction with an event or circumstance, the
terms can
refer to instances in which the event or circumstance occurs precisely as well
as instances
in 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 near
the 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 using
mechanical motion (such as vibration), electrical stimulation, temperature, or
other
sensory stimulation.
[80] Certain biological molecules and anatomical structures exist in a healthy
female to
create engorgement of the vulvar and clitoris erectile tissues. These
molecules and
structures facilitate stiffening the underlying stratum upon which the nerves
in the clitoris
are deployed. The effect of the stiffening is to allow for the more rigid
projection and
presentation of the clitoral structures for stimulation, as well as
mechanically allowing
energy waves to be propagated across the surface more efficiently with less
energy
absorption by the tissues. As a result, a rigid clitoris stimulated
mechanically via
deflection, vibration, and the like propagates these forces across the tensed
surface of the
structure rather than being lost within the loose connective tissue. Thus,
means for
producing an engorged environment (via drugs or via suction, for example) can
enhance
sensation and produce other reflexive responses (e.g., lubrication and
oxytocin release).
Further, the type and distribution of sensory nerve endings within the tissues
of the
clitoris and surrounding tissue explain why certain motions, pressures,
vibrations, and
other stimuli more optimally deliver pleasurable sensations than others.
Vibration and
suction 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
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neuronal/physiologic pathways. Dual-triggering with the use of vibration and
suction
combined provide additive effects. Pacinian or pacini corpusles also called
Vater-pacini
receptors conduct signals in response to vibratory "pressure" (tissue
vibration is
conducted via a pressure wave) ¨ the reflex responses utilize NOS pathways
which
deploy into the same structures that are engorged in the embodiments of the
suction
elements 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 impactful, therefore
moving the site
of vibration is beneficial, whether manually or automatically. All of the
above are
mediated by DH testosterone and other hormonal components (and thus
testosterone
therapy can help improve the quality of the tissues as well as their
"activity") but we have
discovered through mechanical stimulation ¨ either through suction or
vibration or both ¨
many of the hormonal pathways can be bypassed and the reflex responses can be
triggered directly.
[81] We have
discovered that engorgement and vibration together are a powerful
combination such that engorgement creates a more suitable mechanical back-
board for
the pacinian corpusles to be stimulated and that applying both simultaneously
should
produce more profound effects than either applied alone. In both sexes,
engorgement of
the sexual organs is the key physiological target in that engorgement is
fundamental to
achieve an SSE. As illustrated in Figures 31A through 31C, vibrational energy
propagates
better 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 diffuse
stimuli. That is, the vibrating motion supplied by a vibrator is applied
relatively evenly
over the clitoris and surrounding tissue. In certain vibrating devices that
are capable of
delivering vibration over a more tightly focused area, the frequency and
magnitude of the
vibration 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 patterns of suction. Such complex suction waveforms can provide a
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comparatively organic stimulation experience as compared to prior art
mechanical
stimulation devices. For some users, the variable suction patterns, algorithms
waveforms
of 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
described
herein are capable of providing spatially-differentiated vibratory motion.
That is, a
woman experiences spatially-differentiated vibratory motion. In certain
embodiments,
such spatially-differentiated vibratory motion may simulate an experience of
macroscopic
motion about the clitoris. Macroscopic motion can be understood as analogous
to stroking
motion, lingual motion, or motion consistent with intercourse. For some users,
the
spatially-differentiated vibratory motion of certain embodiments can provide
engorgement and stimulation such that effective arousal is achieved without
the use of
suction. For some users, the macroscopic motion about the clitoris of certain
embodiments 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
stimulation
generated by a stimulator(s) from the stimulation generated by another, nearby
stimulator.
By isolating the stimulation generated by one motor from another, a device
simulates
and/or mimics macroscopic motion about the clitoris. Another aspect of
spatially-
differentiated stimulation is isolation of the stimulation generated by a
stimulator(s) from
the 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
embodiments
disclosed herein, is that a small device may be discreetly worn 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 into
contact with vibrating elements. Certain devices remain in contact with tissue
by virtue of
the suction applied to the tissue. Yet another benefit of isolating vibration
in devices is
that the airtight seal between the device and tissue is not substantially
disrupted by the
vibration. This type of vibration isolation involves substantially isolating
the sealing
elements of the device from the vibrating elements in the device.
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[88] The compact size of devices disclosed herein makes them capable of being
discreetly worn and capable of being carried in a purse. Yet, devices
disclosed herein are
sized and configured to be accessible and controllable while being worn.
Devices
disclosed herein may be usable prior to and during intercourse or as a program
for
recruitment of blood flow and nerve sensitization of tissue. Devices disclosed
herein may
be adjustable and customizable and provide selectable, variable suction and
vibrational
properties. Devices disclosed herein may be capable of being controlled
remotely, such as
by 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 following
characteristics: (i) has a suitable fit; (ii) provides appropriate
stimulation; (ii) is
sufficiently comfortable or tolerable; and (iv) performs reliably and safely.
[91] Regarding suitable fit, the following attributes may be present in a
device having a
suitable fit: (i) the device is wearable while ambulatory without the need for
a tether or
additional garment; (ii) the device is sized such that the attachment area
fits between the
labia majora inferior to the clitoris and the housing may exit the labia
majora superior to
the 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
configured
such that placement of a portion of the device posterior of the labia majora
is sufficient to
securely hold the device in place, with or without additional suction.
[92] According to certain embodiments, suitable fit can be achieved by
providing some
or all of the following parameters: (i) the device design and center of
gravity allow the
device to hold to the tissue for at least 5 minutes without a tether; (ii) the
device may be
worn 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 a
compliant tissue interface region; (vi) the device stays in place while
standing and
walking while wearing the device; (vii) the footprint of device attachment
area is
anatomically 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 external
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device envelope allows for discreet use; (xi) the device is designed such it
does not
occlude or limit access to the vaginal opening; (xii) the device body can
withstand a force
compressing 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 or
more motors to a detectable level of vibration to allow the user to center the
stimulatory
effect about the clitoris. By pre-activating the motors during placement, the
user can
customize the fit and determine the most effective location for vibrational
simulation
and/or suction stimulation.
[94] Regarding appropriate stimulation, one or more of the following
attributes can be
present in a device providing appropriate stimulation: (i) the device applies
suction to the
vulvar region or more specifically the clitoral region to facilitate
engorgement of the
clitoral tissues; (ii) the device is capable of applying vibrational energy to
at least the
region of clitoral tissues; and (iii) the device provides stimulation for a
sufficient period
of time to achieve the desired degree of arousal.
[95] According to certain embodiments, appropriate stimulation may be achieved
by
providing some or all of the following parameters: (i) the device provides
suction to the
clitoral region in a range of about 0.7 in Hg to about 9 in Hg; (ii) the
device provides
suction with the optional addition of personal lubricant in an environment in
which pubic
hair is present; (iii) the device maintains the selected level of suction for
a minimum of 5
minutes; (iv) the user can control the level and pattern of suction including
via use of
wireless remote control; (v) the device generates vibration within the
frequency range of
100-300 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
single
battery 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 be
present in a device that is sufficiently comfortable and tolerable: (i) the
device allows for
the 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
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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
be
achieved by providing some or all of the following parameters: (i) the user
can release the
suction within 5 seconds when desired; (ii) the device does not produce sound
that
exceeds 70 dB, as measured at a distance of 2 inches from the outside of the
shell when
attached 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
present
in a device that performs 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 be
achieved by providing some or all of the following parameters: (i) the battery
and
electronics compartment(s) isolated from incidental contact with fluids; (ii)
the maximum
discharge rate of battery is not considered hazardous; (iii) the device life
may be rated at
2-3 years; (iv) the stimulators are rated for at least sufficient use; (v) the
device is water
resistant 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 is
able to customize the suction and vibratory stimulation to suit their needs;
(ii) the device
withstands 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 is
able to detach the suction tube from the device without losing vacuum pressure
that leads
to device detachment; (iii) the user is able to control vibration function by
means of
wireless remote control; (iv) the user interface is via i0S, Android, or other
mobile
operating system application on a Bluetooth enabled device or via an RF or
Bluetooth key
fob styled controller; (v) the user is able to control vibration parameters
such as pattern
transition speed and vibration amplitude; (vi) power is provided via an
internal
rechargeable battery, not accessible to the user; (vii) the user is able to
control/direct
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vibration focus through pointing with finger on a wireless enabled device;
(viii) the user
is able to control degree of motor overlap; (ix) the motor overlap optimized
for organic
feel; (x) the device is enabled with basic rotational motor patterns; (xi) the
device
withstands an external force applied to the external shell (over the
attachment area) by the
user; (xii) the shell withstands sufficient vacuum cycles without loss of
integrity; (xiii)
the user is able to customize the motor pattern including direction, motor
selection,
looping, and save / recall the customized pattern; and (xiv) the user is able
to customize
the suction pattern and save / recall the customized pattern. Studies have
shown that
different areas of the female brain are activated when the clitoris is self-
stimulated than
when the clitoris is stimulated by a partner and that often times a female can
achieve
orgasm easier through self-stimulation than when stimulated by a partner. With
the
certain embodiments of the devices described herein, the female can record the
stimulation pattern that allows her to achieve orgasm through self-stimulation
and store it
in the devices memory. Subsequently, the device can be used during intercourse
to play
the saved pattern such that the female can achieve orgasm as if she were self-
stimulating.
[102] Preferred attributes of certain embodiments include: (i) user adjustable
suction for
fixation and blood flow recruitment; (ii) user adjustable vibration for blood
flow
recruitment 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
and battery
and connects to suction zone; (ii) compliant wings to improve attachment;
(iii) multiple
stimulators attached to inner walls of compliant suction zone; (iv) motors
isolated 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 for
providing suction to the receptacle. The squeeze bulb can be integral to the
housing or it
may be removable. The receptacle is coupled to adhesive wings capable of
conforming to
interact with tissue. The wings are designed to conform to the anatomy and may
include,
for example, a butterfly-like shape. The wings may help stabilize the device
and maintain
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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, or
other 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,
preferably
macroscopic motion, to simulate the motions naturally used by women to
stimulate the
clitoris in contrast to high-frequency mechanical vibrations of certain prior
art devices.
Some embodiments provide multivariate stimulation of the clitoris via a
stabilized
platform. By mechanically stabilizing a platform, such as through suction
attachment, it is
possible to create a broad array of stimulating effects directly against the
target clitoral
tissues. Such effects may be difficult to achieve on a non-mounted platform.
Examples of
macroscopic motions include a rotary motion, a linear stroking motion, a low
frequency
"thumping" motion, and combinations above. Such macroscopic motions may be
combined with vibration, for example, simple vibration or multiple and/or
complex
waveform vibration.
[108] Certain embodiments of the device provide variable suction. In such
embodiments, the user may rapidly and easily adjust the suction levels.
Further, in certain
embodiments the variable suction is programmable such that the amount of
suction
applied by the device can vary according to a pattern. In some instances, the
suction
pattern is complementary to the vibration and/or macroscopic motion patterns.
The device
controller includes a means for controlling the suction patterns, pre-loaded
suctions
patterns, user-configurable suctions patterns, or combinations thereof. The
device
controller enables the user to selected pre-loaded combinations of a suction
pattern, a
vibrational pattern, and/or a macroscopic motion pattern 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 to
one 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
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include onboard controller circuitry, such as a circuit board, as well as a
user control pad.
Alternately or additionally, device body 110 may include an antenna for
communication
with a remote control device. Device body 110 may include a power source, such
as a
battery. Device body 110 is coupled to suction chamber 120. Suction chamber
120
includes sealing edge 125, which is capable of providing a substantially
airtight seal
against tissue. Sealing edge 125 may be a flange having a wider width than is
pictured in
Figures 1A through 1D. Suction port 130 is in fluid communication with the
interior of
suction chamber 120 and provides a connection to a suction device (not
pictured), which
created negative pressure within suction chamber 120. Suction port 130 may
also include
a check valve or other one-way valve such that when negative pressure is
applied to
suction chamber 120 the check valve or other one-way valve prevents suction
loss
through the valve. Optionally, device body 110 may include an onboard pump
system to
provide the initial suction to suction chamber 120. Further, the onboard pump
system may
further include a pressure sensor to maintain a desired level of negative
pressure within
suction chamber 120 despite the presence of any leaks that may occur along
sealing edge
125. Although not pictured in this embodiment, device 100 may include the
suction
chambers, 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
according
to one embodiment. These figures depict vibratory motors 180 arrayed within
the interior
of suction chamber 120. In certain embodiments, the vibratory motors 180 are
miniature
coin style motors, which have an eccentrically rotating mass that provides
vibratory
motion. Device 100 is designed such that the vibratory motors 180 engage
tissue when
tissue is drawn into suction chamber 120. Vibratory motors 180 can be embedded
in the
walls of suction chamber 120, or they may be otherwise mounted in connection
with
suction chamber 120. In certain embodiments, it is preferable to minimize the
transfer of
vibration from vibratory motors 182 to the housing of suction chamber 120.
Preferably,
the majority of the vibratory energy is transferred to the tissue contacting
vibratory
motors 180. Vibratory motors 180 may be vibrationally isolated from the rest
of device
100 by using mounting mechanisms that inhibit the transfer of vibrational
motion to the
walls of suction chamber 120. As described herein, vibratory motors 180 may be
individually addressable by the controller circuitry such that patterns of
motion, and in
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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 a
key fob style controller 2300. Charging station 2000 can be plugged into an
electrical
outlet via cord 2050. Device 2200 can be placed inside device cavity 2250 and
controller
2300 can be placed in controller cavity 2350. The walls of the cavities can
have charging
contact points, such as contact point 2255, for charging the device battery.
Or, the battery
of device 2200 can be charged by induction. Station 2000 can contain a
comparatively
high capacity battery that is charged via cord 2050 and is capable of holding
charge and
also recharging the comparatively smaller capacity battery in device 2200 when
station
2000 is unplugged from an electrical outlet. Controller 2300 can be also be
charged by
the methods described herein or their equivalents. Figure 25C depicts device
200 in
charging cradle 2, which has the same attributes as the charging station
depicted in
Figures 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
around
vibratory motors 180 within a suction chamber. The protective barrier helps
reduce tissue
irritation and provides a way to clean and reuse the device. As pictured in
Figure 3B,
membrane 190 has a convex shape, which defines an interior portion into which
tissue is
drawn. 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. During
use when suction is applied through the suction port to the suction chamber
tissue is
drawn in to the suction chamber and against membrane 190. Membrane 190 deforms
towards the interior of the suction chamber while maintaining intimate contact
between
vibratory motors 180 and tissue. Figure 3A depicts two of the vibratory motors
as being
configured 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.
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[113] Figure 3B illustrates a perspective view of the tissue-contacting side
of device 100
according to an embodiment. In this embodiment, vibratory motors 180 are
spaced
relatively close together and thereby form a cavity that is sized to
approximate the
volume of clitoral tissue to be engaged by the device. Figure 3C illustrates a
close-up
view of clitoral tissue cavity. Suction inlet 132 is depicted at the
approximate apex of the
clitoral 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 a
permeable membrane, mesh, or other offset structure. In other words, a fabric
or mesh
screen can be placed over suction inlet 132 to prevent tissue from becoming
trapped
insider the suction inlet. For example, an expanded PTFE membrane can be used
as the
offset structure to provide and maintain a vacuum path between tissue and the
suction
inlet. Figure 3C illustrates protrusions 133 as forming an offset structure.
Still further,
suction inlet 132 may be physically offset from the clitoral tissue cavity by
a narrow
channel that is too narrow for clitoral tissue to penetrate. Still further,
suction inlet 132
can include multiple smaller diameter suction inlets recessed among
protrusions. Such
offset structures can be combined. Still further, the motors can be
sufficiently prominent
or protruding from the surface of the flexible membrane (while still being
covered by the
membrane) to function as offset structures that hold back tissue from blocking
the suction
inlet region. The offset structures function to prevent tissue from completely
covering
suction 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
deeply
recessed into membrane 190 such that one third to one half of the motor
extends beyond
membrane 190 and toward tissue. Deeply recessing the motors places them closer
to
tissue and provides a deep clitoral tissue cavity. Close proximity to tissue
and a deep
clitoral tissue cavity can each provide higher stimulating forces as compared
to shallowly
recessed motors. It is advantageous to transmit as much force as possible from
the motor
to the tissue, particularly in the embodiments in which the device is
maintained in contact
with tissue by suction. In such embodiments, it is advantageous to transmit
the force
efficiently to tissue since the motors are relatively low power and force
losses will
dampen the stimulation effect.
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[115] Figures 3B and 3C depict channels 192 in membrane 190 that at least
partially
surround the recessed portion of vibratory motors 180. Channels 192 can be a
thinned out
portion of membrane 190 and can be part of the membrane mold or can be created
by
removing material from the membrane after molding. Channels 192 function to
help
provide 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 a
flow path to suction inlet 132. Channels 192 also function to isolate the
vibration of a
given motor from the rest of the membrane and the body of the device. Being
thinner
regions than the surrounding membrane, channels 192 can flex more and reduce
or
prevent vibrational energy loss that might otherwise be transmitted to the
relatively
thicker and less flexible parts of the membrane. Minimizing or eliminating
vibrations in
the membrane from being transmitted to the device body has the advantages of
avoiding
undesirable 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 motors
180 according to an embodiment. Figure 4A depicts a view of the interior of
suction
chamber 120 and depicts stimulating features 185 coupled to vibratory motors
180. When
tissue is drawn into suction chamber 120, stimulating features 185 transmit
vibratory
energy generated by vibratory motors 180 to the tissue. Stimulating features
185 may
have a variety of shapes, textures, and configurations. Stimulating features
185 may be
different 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
miniature
vibratory motors 180 according to an embodiment. In this embodiment, miniature
vibratory motors 180 are cylindrical in contrast to the disk-like miniature
coin-style
motors. 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.
Stimulators
180 are spaced apart by isolating arms 188. Isolating arms 188 provide a sub-
assembly in
which stimulators 180 can be assembled. Isolating arms 188 function to isolate
the
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vibrational energy of one stimulator from another stimulator. This is useful
in
circumstances where the stimulators are activated at different times and/or at
different
frequencies and/or at different amplitudes. By isolating the vibrational
energy generated
by one motor from the vibrational energy generated by another motor, it is
possible to
simulate macroscopic motion around or on tissue. Figure 6 depicts one type of
vibration
isolation, 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
garment 50.
In this embodiment, garment 50 is a simple strap or belt that connects to
device 100 and
helps maintain its position on the body of the user. In certain embodiments,
garment 50 is
optional as device 100 is configured to maintain its position on the body
primarily via
suction. However, it is understood that for some users an additional means of
maintaining
the position of device 100 may be desirable. Further, it is understood that
device 100 may
be configured to be attached or could be otherwise integral with other
garments including
lingerie or other women's intimate apparel. Jewelry with functional elements
that
stimulate other areas of the skin can be used to increase arousal. Such
functional elements
can be one or more of air blowing across the skin, stroking of a soft element,
application
of slight warming or cooling.
[120] Figures 8A, 8A', 8B, 8B', 8C, and 8C' depict a device 200 according to
an
embodiment. Device body 210 includes suction chamber 220. Suction chamber 220
includes sealing and stabilization flange 225, having a sealing edge 226,
which is adapted
to provide a substantially airtight seal against tissue. Suction port 230
provides fluid
communication between the interior of suction port 220 and a suction device
(not
pictured). Device body 210 includes a user control area, which in this
embodiment
includes activation button 205. It is understood that the user control area
may contain
multiple control inputs. Further, the device 200 may be controlled remotely.
Figure 8B
and 8B' illustrate a bottom view of device 200 and depicts the interior of
suction chamber
220. Multiple stimulators 280 are coupled to the inner walls of suction
chamber 220.
Suction inlet 232 includes a check valve or other one-way valve connecting
suction port
232 to the interior of suction chamber 220. Figure 8C and 8C' depict a cutaway
view of
device 200 and illustrates, in addition to the features already described,
controller block
215. 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
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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
fluid
connectors, 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 and
couples the electronics to suction chamber 220. Device body 210 may further
include a
charging port to recharge the power source included in controller block 215.
Activation
buttons 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 or
may be adapted to contain an adhesive material. Also, the foam or other
material could
contain a lubricant that serves to fill gaps in the seal between the sealing
flange and
tissue. Other structures, such as filaments structures like velour or corduroy
or other
woven or non-woven fabrics can be used at the sealing flange in conjunction
with
adhesives and/or lubricants to provide a secure fit and help minimize leak
paths. In some
embodiments 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
becomes
wet. 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 200
according to another embodiment. Device 200 includes device body 210, which
can
house controller circuitry, and suction chamber 220. The controller circuitry
can be
accessed 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
be
wirelessly connected. Suction body 220 includes sealing and flange 225, which
is adapted
to 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 which
promote 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
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meets suction chamber 220, fits between the labia majora inferior to the
clitoris and
device body 210 may exit the labia majora superior to the clitoris. Further,
the taper of the
upper section of suction chamber 220 facilitates comfortable, discreet, and
secure fit. The
curve of device body 210 can help device 200 conform to the user and allow
discreet
placement inside garments.
[125] Specifically, the front section 225f of sealing flange 225 is placed
superior to the
clitoris and tucked under the anterior commissure of the labia majora. In that
position, the
labia majora inferior to the anterior commissure can snugly engage the tapered
section
220t of suction chamber 220 such that substantially the entire front and
lateral portions of
the sealing flange 225 are tucked under the labia majora. Advantageously, the
tapered
section 220t of suction chamber 220 allows the labia majora to comfortably
engage a
comparatively 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 by
following a few steps. For example, when a user first attempts to place the
device, they
may benefit from the use of a mirror such that the user's head and shoulders
are propped
up and they can use the mirror to observe themselves placing the device. The
user can
open their outer labia so that they can see their inner labia and the hooded
glans of the
clitoris. Users can identify a groove within their outer labia that runs along
the inner labia
at the bottom and the hooded clitoris at the top. Device 200 can be effective
when the
sealing flange 225 is centered over the clitoris and the comparatively soft
edges of the
sealing flange 225 fit into the groove. In some cases the user can tug their
outer labia to
make space for the outer ring to fit snugly in the groove. The vibratory
motors can then fit
snugly around the glans of the clitoris. In some instances, the user can apply
an amount of
a lubricant (such as a water-based lubricant) to coat their inner and outer
labia, the glans
of the clitoris, the hood of the clitoris, and the comparatively soft edges of
the sealing
flange 225. The user can activate the vibratory motors at a relatively low
power setting to
help 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 inner
portions of the vibratory motors. In some cases, the user can apply
stimulation with their
inner 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.
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[127] In certain embodiments, multiple vibratory-disc, or miniature coin-
style, motors
are embedded in the wall of a flexible suction chamber. In certain
embodiments, the
motors are embedded in a flexible membrane, which is attached to the walls of
the
suction chamber. When suction is applied, tissue is brought into contact with
the
stimulator. The motors can be controlled by controller circuitry to produce
one or more of
the following patterns: (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 pattern and spatial
isolation of the
motors may produce a desired effect of simulating macroscopic motion without
incorporation parts that actually move in macroscopic dimensions. Stiffening
members
may be added to the motor mounts to vary and/or isolate vibration. The inner
surface of
the membrane may be textured to transmit vibration to tissue. The flexible
membrane
reduces 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, patterns are created by three
vibratory
motors. For example, rotational patterns (clockwise or counter clockwise) are
created by
first activating motor 180a and then activating motor 180b and then activating
motor
180c. After a motor is activated it can be completely deactivated or have its
power
reduced such that a pattern of higher power vibration rotates around the array
of motors.
As another example, a V pattern of vibration is created by simultaneously
activating
motors 180a and 180b, then deactivating both, and then simultaneously
activating motors
180a and 180c and then deactivating both. The V pattern can then be repeated.
As another
example, a lateral pattern is created by alternating activation and
deactivation of motors
180b and 180c while motor 180a remains deactivated. As another example, a
lateral
pattern is created by alternating activation and deactivation of motors 180b
and 180c
while motor 180a remains activated.
[129] The patterns described above and equivalent patterns can be created by
arrays
with more than three motors. Rotational patterns, lateral patterns, vertical
patterns, and
combination thereof can be created by selectively activating and deactivating
motors. All
such patterns are within the scope of the invention disclosed herein
regardless of the
number 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
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vibratory motors. That is, one or more of the vibratory motors can instead be
an electrical
stimulator, temperature stimulator, or other stimulator.
[130] In certain embodiments, multiple vibratory motors create resonance or
diphasic
amplification. Resonant or diphasic amplification patterns may be advantageous
because
they may create unique vibratory patterns that would be difficult to achieve
with a single
vibrating source, and they may create amplification in vibratory power that
exceeds the
capability of a single motor. Such amplification may be useful in the case of
certain
electrical power or space constraints. Resonance or diphasic amplification
created
through the use of multiple vibratory sources may employ different sources
including
rotary motors, linear motors, and piezoelectrics. The combination of multiple
sources
may create a large range of customizable and selectable resonant patterns.
Further, motors
of different sizes and/or power can be used to create multiple resonant
frequencies to
amplify the vibration effect.
[131] Multiple, isolated and independent motors may combine to produce
diphasic
amplification or resonant patterns and/or may simulate macroscopic motions.
Transitions
between motors are smoother with sine wave than square wave. Optimizing the
timing
and the amplitude of the motion during transition improves the "organic" feel
of the
stimulation. Preferably, multiple small motors are used to provide easily-
differentiated
stimulation and simulation of macroscopic motion. Small eccentric motors
placed on
edge provide a focused vibration point, which promotes differentiation among
several
vibration 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 an
embodiment. Device 300 includes suction chamber 320 and sealing edge 325,
which are
both configured to engage tissue as described herein. In this embodiment
suction chamber
320 is flexible and deformable such that motor 380 deforms suction chamber 320
as it
traverses suction chamber 320 via rails 370. Motor 380 may be coupled to a
cylinder or
may 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
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and promotes blood flow and/or clitoral engorgement. Suction chamber 320
includes a
suction port (not pictured), which is used similar to suction ports described
herein and
includes a check valve or other one-way valve to maintain suction in the
chamber. Motor
380 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
motion
according to an embodiment. Device 400 includes device body 410 and dome 420.
Dome
420 is configured to rotate with respect to device body 410 about an axis
central to both
device 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 draw
tissue into contact with stimulating features 485. A motor (not pictured)
drives the
rotation of dome 420 with respect to device body 410 and rotates stimulating
features 485
about the clitoral tissue drawn into the interior of device body 410.
Stimulating features
485 may also be driven by vibratory motors to provide both a stroking motion
and a
vibratory motion.
[135] Alternately, the motion of the dome may be driven magnetically. For
example,
dome 420 may include a single offset magnet. Device body 410 may include
several
electromagnets, which are individually addressable by a controller. The motion
of the
dome can be driven by selectively charging each electromagnet in a sequence or
pattern.
[136] Figure 11 depicts one embodiment of a device 700 in which a moving tread
775
under a stationary membrane 790 provides macroscopic motion for stimulation.
The
moving tread 775 is housed under a thin membrane 790, which is compliant and
flexible
and moves with features on the tread. The tread 790 has raised regions 777
spaced apart
from 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 510
is attached to flange 525, which is configured to maintain a substantially
airtight seal
against 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 flange
525. Optionally, a lubricant and/or an exothermic substance may be applied to
the tissue-
contacting surface of flange 525. Flange 525 is flexible and conformable and
adapted to
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provide a reliable and comfortable anatomical fit. Device body 510 includes a
suction
chamber (not pictured) capable of drawing tissue into its interior. Device
body 510
includes 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
600
includes suction chamber 620, which is configured to apply suction to tissue
through a
suction port or other mechanism as described herein. Device 600 includes a
stimulator
680 and power source such as a battery. Stimulator 680 is suspended from
suction
chamber 620 via an adjustment arm 640. Adjustment arm 640 allows a user to
precisely
and repeatably control the force of contact between stimulator 680 and tissue.
Device 600
includes an activation button 605 and can include remote control capabilities
via an
onboard antenna. Alternately, the adjustment arm can be electronically
controlled, such as
by 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 a
thin flexible membrane 810 designed to deliver a pulsating wave along its
length. A
flexible electronic controller 850 drives one or more flexible actuators 860
that are at
least partially encapsulated in the thin flexible membrane 810. The flexible
membrane
may have a curved configuration that defines an internal chamber. Suction can
be applied
to the internal chamber through various mechanisms, including a deformable
suction
chamber 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 wave
motion. The speed and amplitude of the wave is variable, selectable and
adjustable in real
time. The wave motion can also be used to deliver therapeutic substances
directly to the
genital region. The substances can be stored in the polymeric adhesive region
or
immediately behind the adhesive region. The mechanical displacement algorithm
or,
alternately, an algorithm focused on delivery, could be used to meter out drug
at the
desired rate. Thin-film actuators include shape memory polymers and metals,
ferroelectric thin films, polymer thin films, piezoelectric films,
polymer/metal
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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 by
sequentially charging regions of the thin-film actuator. As each region is
energized, that
region undergoes a conformational change that causes a local displacement of
the
structure. Various temporo-spatial patterns can be created to stimulate a
stroking motion.
Alternatively, some regions may be made to vibrate all other regions provide a
simulated
stroking motion. The thin-film may be electrically activatable polymer, a
piezoelectric
material, shape memory polymer, a shape memory metal, or composite material
containing one or more of the following materials: metals, polymers,
particles, strips,
charge elements, water, salt, bases, acids, etc. In some embodiments, the thin
film
actuator 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
coupled
thin-film actuator 900 and controller 950. The thin-film actuator 900 is
applied to the
clitoral hood and the controller 950 is placed into the vaginal vault. The
controller 950
delivers a variable wave electromagnetic energy to the thin-film actuator 900,
causing the
actuator to vibrate. If the electromagnetic energy is provided by a rotating
magnet, the
magnet may be eccentric in weight. Such eccentricity allows for local
vibration or may
also be weighted such that only the thin-film actuator is vibrated. The thin-
film may be
disposable and comprised of other magnetically adherable material. The
controller may
be onboard the device or maybe remote. The density of the magnetic element
allows for
variable focus of actuation along the surface. There may be an adhesive layer
910, such as
a mildly adhesive polymer layer, to adhere to tissue. The vibration is caused
by
electromagnetic activation of magnetic layer 915, which resides between
adhesive layer
910 and surface layer 920. The controller includes a rotary magnet, a motor,
circuitry, and
the 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 the
vagina 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
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positioning of the device. Advantageously, by moving the relatively heavier
control and
power components from the clitoral device to the vaginal device, the clitoral
device may
be 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 is
in contact with the top or anterior surface of a suction chamber 1120. Device
1100
includes flange 1125, which provides a substantially airtight seal with tissue
while being
reasonably comfortable and wearable. Suction chamber 1120 draws tissue into
its interior
using a separate suction device or by deformation of the suction chamber prior
to the
device 110 being placed in contact with tissue. When tissue is drawn within
suction
chamber 1120, stimulator 1180 (or more than one stimulator) may be used to
stimulate
clitoral tissue. Stimulator 1180 (or motors) may be controlled via a user
control area on
device 1100 or remotely.
[145] Certain embodiments of the invention take advantage of a wide spectrum
of
input, wider than the input available from certain prior art devices. For
example, input
may include complex waveforms such as literal music, or superimposed waveforms
that
make up a type of "song." The multiple oscillations of a "song" can produce a
desired
mechanical effect on the actuators in contact with tissue. The location or
spatial
placement of these "songs" could be distributed differentially across the
target tissue
surfaces to produce enhanced effects. For example, some regions may be more
optimally
stimulated through low-frequency patterns in other areas through higher
frequency
patterns. High amplitude patterns in combination with variable mid to high
vibrations are
also possible. By adjusting these effects spatially, the simulation of manual
stimulation,
lingual stimulation, or intercourse may be achieved. Multiple stimulation
signatures are
available to the user to produce different effects. Nominally, some tissue may
respond
more to a simulated "rubbing" effect and others to a more cyclic "depression"
or
thumping effect. The "songs" may be downloadable to a remote player or to the
device
itself through web-based media marketplaces, such as iTunes. Figure 17
illustrates a
device 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 driver
1282 is individually addressable by a controller to generate the complex
waveforms and
patterns of stimuli described herein.
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[146] Figures 18A and 18B illustrate the interaction of a device 1300 and a
separate
suction device 1320. The combination of device 1300 and suction device 1320
provide a
kit for use according to embodiments described herein. Device 1300 includes a
suction
port 1330 that is in fluid communication with the interior of a suction
chamber (not
labeled) on device 1300. Suction device 1320 is depicted as a syringe-type
suction device
but other suction devices are within the scope of this disclosure. A separate
suction device
allows 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 feature
1485 is driven by a motor housed within a device body 1410. Device 1400 is
placed in
contact with clitoral tissue by suction means described herein or by placing
the device in
close contact with tissue via a garment or garment-like apparatus. Stimulating
feature
1485 provides macroscopic motion to stimulate engorgement of the clitoris by
providing
a 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 a
control surface to the tissue-contacting surface of the stimulating part of
the device. By
pressing their fingers on the control surface, the user can create various
levels of pressure
a vibration in the corresponding location on the tissue-contacting surface. As
the user
moves their fingers across the control surface and optimally desired way, a
sequence of
motions, pressures, vibrations, and/or stimuli that mimic these actions are
created on the
tissue-contacting surface. These movements and inputs can be stored either
locally on the
device or a controller level and played back when desired to create desired
effect without
requiring the user to repeat their input pattern.
[149] Figure 20 illustrates an embodiment of a device 1500, which can be
remotely
controlled by a touchpad device 1550 to provide precise and customizable
stimulation.
Touchpad device 1550 may be a smartphone or other equivalent device. Device
1500
includes electro-active layer 1580, which directly contacts tissue or contacts
tissue
through a thin membrane. Tissue is drawn into contact with electro-active
layer 1580
through methods described herein. Device 1500 includes a power source 1515, a
local
controller 1505, and an antenna 1535. Electro-active layer 1580 is configured
to mimic
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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 configured
to send
radio-frequency signals to the device worn by the user. The controller may be
sized
similar to a key fob remote control commonly associated with automobiles. A
key fob
styled remote can include several buttons capable of controlling the full
range of
functions of the device discussed herein. Figures 26A and 26B illustrate a key
fob styled
remote controller 206 and device 200, which includes a complementary housing
space
202 such that the remote 206 can be docked with the device and housed there
when not in
use or even when in use. In general, the controller circuitry can include a
circuit board,
amplifiers, radio antennae (including Bluetooth antennae).
[151] Devices using low power Bluetooth or other radio antennae may experience
dropped connections when the remote/device pair is separated by distance or by
a
physical obstruction (such as a user's or partner's body). In such cases, it
is desirable for
the device to remain operating under its pre-drop operating conditions while
the remote
attempts to automatically pair again with the device. Said differently, it is
undesirable to
require the user or partner to have to manually re-establish the Bluetooth
pairing between
the remote and the device if the pair connection is lost during device use.
And, it is
undesirable for the device to cease operating under its existing pre-drop
conditions if a
pair connection is lost. Thus, certain remotes are configured 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
connection
with the device, it can be important for the remote to query the device for
the current
device operating conditions. That is, since the device has maintained a state
of operating
conditions when the pairing was lost, it is desirable that the remote not
interrupt the
device operating conditions when the pair connection is re-established. As a
counter
example, 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 undesirable
in the circumstance where a device is operating under a given set of
parameters, patterns,
or programs because those parameters, patterns, or programs would be
interrupted by the
reset signal. Such an interruption could be detrimental to the user
experience.
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[153] In certain embodiments, the controller is physically tethered to the
device worn by
the 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 suction
chamber, an arm suspending a vibratory motor, or stimulating feature, can be
controlled
by 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
is
coupled to the end of lever 195. Lever 195 has an interior receiving lumen for
receiving a
stiffening stylet. By stiffening lever 195, which may be attached to a device
body, or to a
suction chamber such as the chamber pictured in Figure 13, the stimulator 180
may be
made to more firmly engage tissue. Figure 22 depicts an embodiment in which
lever 195
is coupled to oscillating motor 180, which is attached to suction chamber 120.
Lever 195
is driven to have a larger motion at its far end relative to the smaller
motion of oscillating
motor 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
mounted
within suction chamber 120. Figure 23A depicts a sectional plan view and
illustrates a
mechanism including two levers 195 and two pivot points 196. The pivot points
and
levers cooperate to sweep stimulator 180 across the target tissue. While the
mechanism is
depicted with two lever and two pivot points, other combinations of mechanical
elements
are possible provided that they generate a controllable sweeping or stroking
motion
across the target tissue. Figure 23B depicts a sectional end view, which
illustrates
stimulator 180 as both sweeping across tissue and pivoting about the
longitudinal axis of
lever 195. In certain embodiments, the pivoting motion is passive and conforms
to the
shape of the tissue to maintain substantial contact between stimulator 180 and
target
tissue. In other embodiments, the pivoting motion is actively controlled and
can be used
to 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
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capable of driving the sweeping motion or they may be comparatively simple
joint that
allow 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 the
tissues and vibration to provide stimulation to the region. In other
embodiments, the
device delivers suction to engorge and stiffen the tissues and electrical or
neural
stimulation provides stimulation to the region. In other embodiments, warming
or cooling
is 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 those
stimulation 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 is
spatial differentiation between sources and minimal diffusion of vibratory
energy to
adjacent structures in the device or tissue. Mounting stimulators on a
flexible membrane
which travels with the tissue as it becomes engorged with suction may
accomplish these
goals. However, the membrane should have a direct path between the suction
source and
tissue ¨ if there is no path the amount of suction delivered will be
significantly lower.
Placing holes or slits in the membrane may allow for sufficient vacuum and
energy
transfer. However, holes or slits are placed in the membrane may allow fluid
from the
tissues 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 device
according to certain embodiments. Device 200 includes device body 210 and
suction
chamber 220. Suction chamber 220 includes sealing flange 225 including sealing
edge
226, which is adapted to provide a substantially airtight seal against tissue.
Suction port
230 provides fluid communication between the interior of suction port 220 and
a suction
device (not pictured) that can be detachable or remain attached. Device body
210 includes
a user control area 215. It is understood that the user control area may
contain multiple
control inputs. Further, the device 200 may be controlled remotely. Multiple
vibratory
motors 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
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port 232 to the interior of suction chamber 220. Device body 210 includes a
firm but
flexible shell, which houses electronics and couples the electronics to
suction chamber
220. Device body 210 may further include a charging port to recharge the power
source
included in controller block 215. Activation buttons present in the user
control area may
be recessed or otherwise made comfortable, safe, and reliable. Sealing flange
225 may
include soft, flexible, compliant material (e.g., silicone), and may
optionally be mildly
adhesive to tissue or may be adapted to contain an adhesive material. Device
body 210 is
configured such that the posterior, or underside, of device body 210 is in a
different plane
than sealing flange 225. This configuration allows device body 210 to ride
over the pubic
bone of the user and to optionally attach to a garment while sealing flange
225 is in
contact with tissue.
[160] Figure 27B depicts suction tube 231 connecting suction inlet 232 with
suction port
230. 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 for
pressure drops and to avoid areas where fluid may pool. The suction tube
provides an
additional 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 between
the chamber above and below the membrane. When suction is applied, the area
above the
membrane is at higher pressure than the area below the membrane which can
encourage
the membrane to move down toward tissue, thereby increasing contact forces
between the
motors 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 by
enabling the flexible portion of the suction cup to be removed from the
housing so it can
be cleaned by the user. Alternately, as depicted in Figures 27A and 27B, a
tube could be
connected between the suction luer and a single hole in the membrane. The
interior of this
hole may have features (e.g., protrusions, a permeable shield, and the like)
to prevent the
tissue 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
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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
Figure
33, no fluid is allowed to enter the interior 282 of the device 200 such that
the surface
under suction chamber 220 and all of the external surfaces of device 200 can
be easily
cleaned 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 284
has an 0-ring 286 to form a seal around the button. Button 284 is mounted on a
spring
288 such that when button 284 is depressed and released it is biased toward
its starting
position. Sealing flange 225 creates a seal, primarily at sealing edge 226,
with the
woman's tissue. Suction chamber 220 is a resilient membrane dome that is
biased to
return to its starting position. Displacement of button 284 forces pressure
downward on
the resilient membrane dome which forces air out from under suction chamber
220. The
sealing flange 225 in contact with the tissue acts likes a one-way valve and
as the button
is released, the resilient membrane tries to return to its starting position
thus creating
suction under suction chamber 220 to create negative pressure over the
clitoris and
encourage 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 underneath the outer housing
and
between 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 into
an interface cable (or an interface port in a holder) that can be used to
program and/or
charge the device. Battery 212 is underneath controller block 215.
[165] Certain materials may be preferable for use as actuators in devices
disclosed
herein. For example, electro-active polymers expand and contract with the
application of
electrical current and can incorporate taxels (focal points) to increase
resolution. Electro-
active polymers can be packed in dense arrays, are highly customizable, and
show good
frequency range. Some designs are extremely low profile. Piezoelectric
materials are
another example. Piezoelectric crystals generate stepping function movement
that can be
used for rotary or linear motion and / or vibration. Piezoelectric materials
can be
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miniaturized and incorporated into electronics and show good frequency range.
Another
example is voice coils in which linear motion is caused by generation of
electrical field
around 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 ¨
the
frequency and amplitude can be decoupled from each other. Voice coils also
allow for
greater 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
provides
high spatial resolution for vibrations. For example, an array that provides
for 14 vibratory
sources could improve the sensation of motion delivered to the user and
provide for
significant customization modes. In this example, each vibration node is 4mm
in
diameter, significantly smaller than the 8 to 15 mm diameter coin cell motors.
A vibration
node 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 (or
macroscopic motions such as palpation or rubbing) using an array of
vibrational motors.
Devices disclosed herein are capable of achieving (or at least simulating)
kinesthetic (or
macroscopic) sensations using actuators that typically produce only tactile
sensations.
Devices capable of producing a convincing, organic-feeling palpation sensation
rely on
the coordination of: (i) motor spacing in the array (preferably, motors are
spaced at about
1-4 mm); (ii) breadth of field of each motor; (iii) traversal rate for a
pattern played on the
motors; and (iv) overlap.
[169] According to certain embodiments, devices fabricated as described herein
are able
to tune strength, traversal rate, and overlap, to the fixed physical
parameters like the
motor spacing, skin contact, etc. Various algorithms allow independent control
of motor
strength, traversal rate, and overlap. In a device fabricated according to
embodiments
disclosed herein, an algorithm was implemented in a low-cost embedded
microcontroller.
Three input parameters were varied, by radio control using Bluetooth Low
Energy
components communicating from an iOS device (iPod of iPhone 5 generation) to
an
embedded microcontroller (Texas Instruments CC2540), to ultimately set those
algorithm
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input parameters. The algorithm output controlled pulse width modulated drives
for all 3
to 5 motors simultaneously. The algorithm also allowed for unique patterns
such that the
user 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
coordination
discussed above can be achieved. In some embodiments, an accelerometer may
compensate for effects of gravity.
[171] Miniature coin-style vibratory motors having an eccentric mass are used
in certain
embodiments. Generally speaking, coin-style motors require larger masses and
higher
power in order to increase the stimulating force delivered to tissue. Thus,
the stimulating
force in eccentric motors is a function of mass, and more power is required to
drive that
mass. In certain embodiments described herein, despite the relatively high
mass and
relatively high power of the motors the devices can provide spatially-
differentiated
vibration via the isolation structures and methods described herein. Even when
the motors
are positioned relatively close together to provide a close fit to the
clitoris, embodiments
described 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. As
described above, voice coils can achieve high amplitude with low voltage and
are smaller
size than miniature coin style motors. Voice coils can be modified to include
a mass
attached to the membrane driven by the electromagnetic field. Advantageously,
such
mass-bearing voice coils retain the desirable properties of voices coils,
including rapid
response 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 or
another remote controller. A user may remotely select a pressure and the
device will
change 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
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diaphragm pumps may be used as onboard pumps. Further, the motor driving the
diaphragm pump may be used to produce vibratory motion. In certain
embodiments, the
onboard pump can be a modified voice coil designed to mimic the action of a
diaphragm
pump. The onboard pump can alternately 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 the
macroscopic motion of stimulators in the device. The algorithms described
herein to drive
vibration are adapted to vacuum pump system to provide fast response times and
physically differentiable levels of suction to the clitoris. Further, certain
embodiments use
simultaneous or sequential suction waveforms or algorithms and vibration
waveforms or
algorithms to amplify the effect of the device.
[175] In some embodiments of the device and method, variations in the
stimulation
parameters 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 a
comparatively lower power and/or lower frequency setting. In the case of coin
cell type
stimulators, power and frequency are coupled such that driving the stimulator
at higher
frequency of oscillation also drives the stimulator at a higher power. To
achieve the
preferred variations in stimulation, the coin cell type stimulators can be
switched between
a high power threshold and a low power threshold. In the case of voice coil
type
stimulators, power and frequency can be decoupled such that a given power of
stimulation can be driven at any frequency. Without being bound to a specific
mechanism
or 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
stimulators
and suction patterns is that different parts of the anatomy can be stimulated
at different
frequencies. For example, different parts of the frenulum can be stimulated at
different
frequencies. It is generally understood that different nerve types will be
stimulated to a
different degree at a given frequency and that different nerves are more fully
stimulated at
different frequencies. One of the advantages of certain embodiments is the
capability of
delivering the appropriate frequency and intensity stimulation and/or suction
to the
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different parts of the vaginal anatomy. For example, with the three
stimulators positioned
as shown the center stimulator primarily stimulates the glans of the clitoris
and the right
and left stimulators stimulate the right and left crus, respectively, (and/or
frenulum) of the
clitoris. 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 a
leak path. Further, a valve in line with the suction tube that can be manually
manipulated
by the user to release suction. In embodiments using an onboard suction pump,
the pump
can be configured to include a constant leak path that the pump overcomes ¨
therefore, if
the pump stops the device will automatically release. Still further, the
device can be
configured with a button that the user presses which opens a valve in the pump
to release
suction. Still further, the valve needed for the suction pump could be
normally 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
to
increase blood circulation in vaginal tissue to promote engorgement to the
clitoris and
external genitalia while simultaneously applying stimulation to the clitoris
and/or other
vaginal tissue. The clitoris is a sexual organ that is filled with capillaries
that supply
blood 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
sexual
dysfunction, methods and devices of certain embodiments can provide: (i)
increased
genital sensation; (ii) improved vaginal lubrication; (iii) improved sexual
satisfaction; (iv)
improved sexual desire; and/or (v) improved orgasm. Certain embodiments of the
invention 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 a
wearable device designed to increase sexual satisfaction. Certain embodiments
of the
invention 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
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prepare her body in advance of a sexual experience, typically with 5-30
minutes of use
prior to sex; worn during a sexual experience with a partner, including
intercourse; used
by a woman alone for recreational purposes to reach orgasm; used as a regime,
typically
used a few minutes every day, to help facilitate a more intense and
pleasurable experience
during 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,
her
partner or physician. Gentle suction allows the product to stay in place (so
it can be
completely hands free once placed), although it can be quickly and easily
removed as
desired. A woman can sit, stand up and walk around while wearing the device
200. As
shown in Fig. 32C, a small remote control 1550 or smartphone "app" is used to
adjust the
device's vibration intensity and unique stroking patterns (such as the counter-
clockwise
movement 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 sexual
stimulation to the clitoral region, working with a woman's body to help
improve sexual
response. 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
washable
with soap and water. It is quick and easy to place on the body, and can easily
be removed.
It may be worn under clothing without anyone knowing the user has it on. Since
it is a
hands-free product, the user can easily move around, stand or walk while
wearing the
device 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
controller
1550. These user interfaces provide means for controlling vibration and
suction patterns,
including pre-loaded patterns, user-configurable patterns, or combinations
thereof Figure
44A illustrates a user interface including a vibration on/off button 1551, a
vibration
pattern selector 1552, a vibration strength selector 1553, and a vibration
cycle speed
selector 1554. The vibration strength selector 1552 and vibration cycle speed
selector
1554 are each shown with a numeric indicator in addition to a slider. The
vibration
pattern selector 1552 can be loaded with pre-loaded patterns or it can be used
to store
user-configurable patterns. The user interface provides an intuitive and easy-
to-operate
means for controlling the vibration and suction patterns of the device.
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[183] Figures 44B and 44C illustrate a user interface including a suction
on/off button
1556, a suction level selector 1557, and a suction alternating speed selector
1558. The
suction on/off button 1556 also includes an "alternating" section setting.
Figure 44B
illustrates that when the suction on/off button 1556 is in the "off' or "on"
position, the
suction level selector 1557 has a single slider point and the suction
alternating speed
selector 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 has
been set to "alternating." In the "alternating" mode, the suction level
selector 1557 has
two slider points and the suction alternating speed selector 1558 is
available. The
"alternating" mode allows the user to set a primary suction level with the
first slider point
and a higher suction level with the second slider point. The device can then
alternate
between these two suction levels at a specific alternating speed that the user
sets using the
suction alternating speed selector 1558. Thus, the user can control both the
difference in
suction levels and the speed at which the device alternates between those two
suction
levels. Further, the user interface can contain a means for the user to store
the two suction
levels and the suction alternation speed. The user interface can include pre-
loaded suction
alternation levels and speeds, user-configurable suction alternation levels
and speeds, or
combinations thereof
[185] Figures 34A through 34D illustrate views of a portion of certain devices
with
different tissue contacting configurations. In each of Figures 34A through
34D, the
interior components, such as the portions that hold the vibratory motors, are
visible since
the outer shell of the device body has been removed. Figure 34A depicts the
device as
having a comparatively steeper curve along the tissue contacting side of the
device. That
is, the curvature of the sealing flange 225 from its approximate midpoint to
the rear
section 225r of the sealing flange 225 has a greater curvature than that same
section of
other device portions depicted in Figures 34B, 34C, and 34D. Further, the
sealing flange
225 of the device portion depicted in Figure 34A has a comparatively longer
inferior
section (the section is described as inferior due to its placement inferior to
the clitoris
when 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
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and to facilitate the interaction between the sealing flange 225 and tissue.
The superior
and lateral flange portions are shorter relative to the longer inferior
section flange portion
to enable superior positioning relative to the clitoris and reduce interaction
with the labia
majoria. For some users, this curvature will improve the fit, comfort, and
reliability of
suction 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 from
a molded piece 22. This single molded piece 22 includes the sealing flange 225
and upper
portions that are connected to the device body. Figure 40 illustrates a
perspective view of
a device and shows the single molded piece 22 attached to the device body 210
to form
the device. The upper portions of the single molded piece 22 are positioned
inside the
device 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
flange
assembly 225' attached. Figure 35B depicts variation in the width of the
flange surface
223'; in this case the flange surface 223' is wider at a portion of the device
that is placed
inferior to the clitoris. As described herein, some embodiments of the
invention include
removable 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
joining
member 229' integral to the removable flange assembly 225'. The removable
flange
assembly joining member 229' couples to the device body and provides a
substantially
airtight seal with the suction chamber to enable operation of the device.
Removal of the
flange assembly can allow for a user-customized fit. That is, the user can
select from a
range of removable flange assemblies that have varying dimensions,
configurations,
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
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width. As another example, the curvature of the sealing flange can be varied
from a
comparatively steep curvature to a comparatively shallow curvature. Further, a
sealing
flange on a single removable flange assembly may have a combination of widths
and
curvatures on its sealing flange. In still another example, the removable
flange assembly
can be made of a combination of materials or from a single material with
varying
properties. For example, the sealing flange can be comparatively softer and
more flexible
(e.g., 0030A durometer silicone) while the removable flange body can be
comparatively
more rigid (e.g., 20A durometer silicone). A comparatively more rigid
removable flange
body can help join the immovable flange to the device body. In yet another
example, the
sealing 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
flange
assembly 225'. Figures 43A-43G show the flange assembly 225' made of a
combination
of materials. The sealing flange 225 is a comparatively softer and more
flexible material
while the flange body 228 that joins to the device body is comparatively more
rigid. The
sealing flange portion and flange body portion are molded together. In the
embodiment of
Figure 43A, the sealing edge 226 has a sharper corner so that as tissue is
sucked up into
the suction chamber it makes a tight turn 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 seal
either 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 suction
chamber it makes a tight turn relative to the sealing surface 223' and then as
the tissue
becomes engorged into expands out over the additional rib of the sealing edge
to create a
tight 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 233
running all the way around the sealing surface 223' and a depression 235
running all the
way 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
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the sealing surface 223' to prevent a suction loss along that hair or tissue.
The depression
235 provides a space for the hair or tissue as well as provides a location for
extra
lubricant to fill in around or over hair or tissue. In the embodiment of
Figure 43D, the
protrusion 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"
running
all the way around the sealing surface 223' and one protrusion 233' that runs
only
partially around the sealing surface 223'. The protrusion 233' is on the wider
flange
portion of the sealing flange 225 which is the portion of the flange that
makes contact
with the vulvar tissue inferior to the clitoris. The protrusion 233' joins up
with the
protrusion 233" to create a continuous seal. The protrusions 233', 233" and
233' are
very soft and flexible so as to form a close fit over any hair or small
differences in folds
of tissue. The dual and triple configurations provide multiple opportunities
to form and
maintain a seal along the sealing surface 223' when a sufficient 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 of
the embodiments of Figures 43A-43G have multiple suction holes 237 in flange
membrane 227'. Some of the holes 237 are placed toward the perimeter of the
suction
chamber in order to facilitate greater sealing at the sealing edge and sealing
surface. The
stimulators are integrated into the suction chamber membrane 220 (not shown in
Figures
43A-43G). The membrane pockets 239 in flange membrane 227' match up and
accommodate the stimulators in the suction chamber membrane 220. The flange
membrane 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
excess
material to conform to variations in the tissue surface. The period and
amplitude of the
wave on the sealing surface will vary with the material chosen for the sealing
surface to
promote 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
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pinching motion at the tissue interface. A gentle pinching of the soft tissue
can close leak
pathways in the area where the inferior section of the sealing flange
interacts with the
labia minora. Figures 43H, 431, 43J, and 43K depicts a sealing protrusion 221
on the
sealing flange 225. The sealing protrusion 221 provides a surface for the
labia to seal
against. More than one sealing protrusion 221 can be used and the sealing
protrusion can
be located in other places on the sealing flange 225. The sealing protrusion
221 may
contain a suction port connected with the suction system of the device to
promote sealing
of 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 and
flange assemblies of certain embodiments can provide one or more of the
following
beneficial properties: (i) smoothing the vaginal tissue underneath and in the
area of the
flange; (ii) distributing the engagement forces between the device and the
vaginal tissue;
(iii) providing physical features that can fit underneath the labia majora;
and/or (iv)
increasing the leak path from the suction chamber to the outside environment.
Each of
these 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 220
and/or the inner portion of the sealing flange 223' such as the sealing edge
226 are the
primary part(s) of the device that form the seal with tissue. That is, until
the seal between
the outer rim portion 220e of the suction chamber and/or the sealing
edge/inner portion of
the sealing flange 223' is substantially disrupted, the device can maintain a
sufficient seal
with tissue. In these embodiments, the sealing flange provides the above
beneficial
properties to augment the seal as well as providing a reliable, comfortable,
and
customizable 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 a
flange membrane 227'. The stimulators are integrated into the suction chamber
membrane 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
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assembly 225' or it may be comparatively looser. The flange membrane 227' may
be
domed, planar, or formed to conform to the geometry of the device. The flange
membrane
227' can be stretchable or compliant or comparatively less compliant. The
flange
membrane 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'. For
example, in some embodiments the removable flange assembly 225' is a molded
part and
the flange membrane 227' can be molded integrally with the removable flange
assembly
225' as a comparatively thinner section spanning the interior of the removable
flange
assembly 225'. The flange membrane 227' can be molded with holes or
perforations
formed during the molding process, or the holes or perforations can be formed
after the
molding process. The holes or perforations in the membrane may integral to the
manufacture of the membrane (that is, the membrane stock material already has
holes or
perforations). In some embodiments, the flange membrane can be placed in the
removable flange assembly mold and overmolded into place during the molding
process
or insert molded. In some embodiments, the flange membrane may be fixed in
place after
the rest of the removable flange assembly has been formed. The flange membrane
can be
adhered in place using suitable techniques, such as adhesive bonding, heating
bonding
and 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
removable
flange assembly. For example, the perforations in the flange membrane are
sized to allow
for airflow through the membrane while reducing the likelihood of capturing
tissue within
the membrane perforation or allowing tissue to be captured within the suction
port of the
device. The presence of the flange membrane enables larger openings in the
motor
membrane to assist in cleaning of the device. In another example, the flange
membrane
can provide further user customization by providing a range of textures for
interaction
with tissue. Further, the flange membrane can have a range of perforation
sizes and/or
patterns 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,
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the removable flange assembly joining member 229' is depicted as a trough
region. In
this embodiment, this trough region couples to the outer rim of the suction
chamber of the
device body. In other embodiments, the removable flange assembly joining
member can
be a projection that fits into a trough region that is located on the device
body. Other
configurations 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 and
reliability of cleaning the entire device. In some embodiments, the removable
flange
assembly is formed of materials that allow the removable flange assembly to be
cleaned
inside a dishwasher while the remaining device body is simply rinsed or
otherwise
cleaned by hand. In such an embodiment, the tissue-contacting parts of the
device can be
cleaned more thoroughly than if the flange assembly was not removable.
Alternatively,
the removable flange assembly may be single use and disposable. A device may
be
packaged with several removable flange assemblies, and these assemblies may be
identical 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
cleaning
the device body. In embodiments without a flange membrane, the flexible
membrane of
the suction chamber includes ports that are configured and sized to reduce the
possibility
of tissue capture and injury. That is, the ports are small and/or offset from
tissue. Small
and/or offset ports can be more challenging to clean reliably and thoroughly
than larger
ports or non-offset ports. Further, the ports 220h can be located toward the
perimeter of
the suction chamber 220 as depicted in Figure 39. Such a location for the
ports 220h can
improve drainage of fluid from the device body after use or after cleaning
when the
device 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 view
of the interior of the device body 210. The vibratory motors 280 are
positioned within
structures in single molded piece 22 such that the stimulation from the motors
can be
efficiently propagated to tissue, and portions of the vibratory motors 280 are
also
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accessible to be connected to controller block 215. In this case, controller
block 215 is
illustrated as a printed circuit board. An onboard pump 135 is also positioned
within
device body 210. The onboard pump 135 is in fluid communication with the
suction
chamber to provide suction within that chamber and is also in fluid
communication with
an exhaust port. The exhaust port is an outlet for air or fluid pumped out of
the suction
chamber and an inlet for air to the suction chamber when suction is reduced.
In some
embodiments, the onboard pump 135 sends air pumped from the suction chamber
across
heat-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 a
component such as a thermistor. Thermistors can be positioned within the
device body
210 or be integral to the controller block 215. When the thermistor detects a
threshold
temperature, it can turn off power to the device and/or vent external 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 via
a closed feedback loop. That is, the controller block is configured to
maintain a target
pressure, which can be set by the user or can be loaded as part of a pre-
programmed
suction algorithm. To do so, the controller block reads real-time data from an
onboard
pressure sensor that is configured to monitor pressure (negative pressure in
the case of
suction) within the suction chamber. Based on the real-time data, the
controller block can
engage the onboard pump to draw more suction within the suction chamber or it
can
engage a check valve in fluid connection with the exhaust port to vent air
into the suction
chamber. In typical operation, after the device has generated sufficient
suction to seal it in
place 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
body
210. The sealing flange 225 is coupled to the device body 210. The curvature
of the
sealing flange 225 provides a comfortable and reliable fit for the anatomy.
Further, the
front portion 225f of the sealing flange 225 has narrower profile than the
rear section 225r
of 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
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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 of
the sealing flange 225 is configured to comfortable and reliably fit at the
apex of the labia
majora.
[208] Figures 41A and 41B also illustrate device body 210 configured to fit
comfortably
and reliably on a user in multiple contexts. Specifically, as seen in Figure
41A the rear
portion 210r of the device body 210 tapers towards the sealing edge 225 of the
device
200. This taper can be helpful in allowing partner access during vaginal
intercourse. A
device without such a taper could hinder such access. Further, as seen in
Figure 41B the
rear portion 210r tapers towards a point with respect to the sides of the
device 200. This
taper can be helpful in allowing a user to stand and walk with the device
engaged. In a
device without this taper, some users may experience disengagement of the
device when
standing or walking due to contact with the users thighs. Still further, the
mechanisms,
controller block, batteries, and other internal components can be positioned
towards the
front of the device body 210. Positioning the internal components in this way
can place
the center of mass of the device in such a way that the propensity of the
device to fall
away or disengage from the user is decreased. That is, having the center of
mass of the
device farther from the user side of the device, or in some cases towards the
rear portion
210r 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 device
body 2410, a sealing flange 2425, and an onboard manual pump 2435. Onboard
manual
pump 2435 is in fluid connection with the suction chamber of the device. The
pump 2435
is depicted as a bellows-style pump in which the user pushes down on the
exterior surface
and thereby expels air from a pumping chamber through an exhaust port. The
pumping
chamber is in fluid communication with the suction chamber via one or more
valves that
allow suction to be pulled from within the chamber but prevent air from
entering the
pumping chamber when air is being expelled from the pumping chamber. Other
manual
pumps, like bulb systems (similar to a blood pressure cuff) or plunger systems
are, may
be used. The onboard manual pump can be locked in a low profile state when the
pump is
not being activated.
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[210] Certain embodiments of the invention include device and methods to
enhance
female sexual wellness and female sexual pleasure and some methods are for
treatment of
female sexual dysfunction. Certain embodiments of the invention include device
and
methods 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
own
sexual response without undesirable, lasting side-effects. A woman will enjoy
sexual
intimacy again and feel confident 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 tissue
therebetween. 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
adjusted
by the user directly (as in manually) or indirectly by selecting certain
stimulation patterns
from the controller.
[212] Figure 45A illustrates an embodiment in which a body vibration source
211 (such
as a vibration motor) on the device body 210 provides a baseline level of
vibratory
stimulation. The vibration on the device body 210 could be, as described in
more detail
below, the result of contacting the device body 210 with a conventional
vibrator.
Alternatively, a body vibration source 211 can be included on the device body
210 in
addition to any of the stimulating elements described herein as delivering
stimulation to
vaginal tissue within a tissue chamber (or a suction chamber). Advantageously,
the body
vibration source 211 provides a level of stimulation that serves to
effectively amplify the
stimulation provided in the tissue chamber. That is, a baseline level of
vibration can
contribute to the engorgement and arousal process, and the stimulating
elements
integrated with the tissue chamber further advance the engorgement and arousal
process.
Further, the internal vibrating motors can be used initially for arousal and
then the body
vibration source may be used as additional vibration for additional sensation
and/or for
attainment of climax. Still further, the baseline vibration from the body
vibration source
211 cooperates with vibratory motors to produce resonant and/or harmonic
vibration
patterns with tissue. Certain users may prefer labial stimulation in
conjunction with
clitoral stimulation, and the body vibration source 211 can provide vibratory
labial
stimulation.
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[213] In related embodiments illustrated in Figure 45B, multiple body
vibration source
211a and 211b can be positioned on the device body 210. When multiple motors
are
positioned on the device body 210, the multiple body vibration source 211a and
211b can
be configured to vibrate at various frequencies, creating various vibration
profiles. The
vibration profiles 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 or
more stimulation sources (such as vibratory motors) 180a, 180b, 180c, and 180d
are
contained within a stimulation chamber 182 and the stimulation chamber 182 is
positioned within the device such that it can contact vaginal tissue and the
clitoris in
particular. The stimulation sources 180a, 180b, 180c, and 180d are free to
stimulate
and/or vibrate within the stimulation chamber 182 and in this way periodically
apply
vibratory stimulation to a bottom surface 183 of the stimulation chamber 182
that is
connected to the suction chamber 120. The stimulation sources 180a, 180b,
180c, and
180d may be connected by wires to a control block, but are other wise free to
move
within the stimulation chamber 182. In some embodiments, the control signals
are
wireless. Further, the motors may be powered and/or charged by RF signals so
that they
need not be tethered by wires. In this case, the stimulation sources 180a,
180b, 180c, and
180d are entirely free to move within the vibratory chamber. One feature of
these
embodiments is that the stimulation sources 180a, 180b, 180c, and 180d are not
suspended 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
features
485 can be made to impinge upon the tissue chamber. Figures 47A-47C operate in
a
manner similar to the embodiments disclosed in Figure 10. For example, an
array of
stimulating features 485 can be positioned above the tissue chamber and the
array can be
rotated or otherwise moved with respect to tissue. In some embodiments, such
as depicted
in Figure 47C, another displacing element 486 can be positioned above the
array of
stimulating features 485 and the movement of the displacing element 486 forces
individual or groups of stimulating features 485 in the array to impinge upon
the tissue
chamber. The displacing element 486 and the stimulating features 485 can be
permanent
magnets or electromagnets such that the displacing element 486 generates
movement in
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the stimulating features 485 by magnetic opposition. In embodiments in which
the
stimulating features 485 are permanent magnets or electromagnets, the
stimulating
features 485 can be positioned in a holding tray or embedded in a membrane to
keep the
elements apart. Without such a holding tray or membrane, the magnetic
attraction among
the stimulating features 485 could cause them to bind together and prevent the
desired
movement. Figure 47D illustrates an embodiment in which an array of displacing
elements 486 is positioned above an array of stimulating features 485. The
array of
displacing elements 486 is selectively addressable to create patterns 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 the
number or moving parts. It is also advantageous to minimize the number of
relatively
expensive parts. The embodiments that use an array of stimulating elements
that are in
some 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
vibratory
source includes a vibrating stylus 3250 connected to a motor 3220. The stylus
3250 is
positioned within a translating frame 3200 that enables the stylus 3250 to be
translated
rapidly to different positions with respect to the tissue within the tissue
chamber (or
suction chamber). In a preferred embodiment, the translating frame 3200 is
configured
such 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 to
electromagnets 3340. The motor housing 3220 can include a permanent magnet or
an
electromagnet, which is actively translated by fields generated by the
electromagnets in
the translating frame. The motor housing 3220 can, alternatively, be moved by
a pulley
type system between movable fixtures on the translating frame. The motor
connected to
the stylus 3250 can be vibrationally isolated from the stylus 3250 and
translating frame
3200 by mounted the motor on a dampening structure, such as a foam. More than
one
stylus 3250 and/or more than one translating frame 3200 can be used in various
embodiments described herein. In some embodiments, the stylus 3250 can be used
to
force stimulating features 485 in an array 48, such as that depicted in Figure
48C, to
impinge 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
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magnet 3255 positioned on the stylus arm. Electromagnets 3253 and 3257 are
used to
translate the stylus 3250 and motor 3220 vibrates the stylus 3250.
[218] In embodiments of the device and method illustrated in Figures 49A and
49B, a
motor 3580 located outside the suction chamber 3590 is connected to or
otherwise
communicates vibration to a link 3530 mounted at least partially within the
suction
chamber 3590. The link 3530 interacts directly or indirectly with tissue
within the suction
chamber via a stimulating feature 3520. For example, the link 3530 may
directly
stimulate tissue by being in contact with the tissue, or the link 3530 may
indirectly
stimulate tissue by communicating vibration to a stimulating member (such as
the array
487 depicted in Figure 48C or depicted in Figure 49C) that is in contact with
tissue. The
stimulating member 3520, such as that depicted in Figure 49C, may have one or
more
projections 3572 that stimulate tissue directly. The projections 3572 may have
a variety
of stifthesses such that they produced a variable stimulating profile. For
example, some
projections 3572 may be comparatively flexible and others may be comparatively
stiff.
The stiff projections transmit comparatively more vibration than the flexible
projections.
[219] In some embodiments, the suction chamber includes end effectors that are
coupled
to and driven by a motor on the outside of the suction chamber. As depicted in
a
schematic view in Figure 50A, one or more end effectors 3630 can be
selectively
addressed by one or more motors 3680. That is, an individual motor 3680 can
move or
vibrate one or more end effectors 3630 as directed by a controller. Further,
the controller
can direct the individual motor 3680 to move or vibrate just one end effector
3630 or
multiple end effectors. If the individual motor 3680 is directed to move or
vibrate
multiple end effectors 3630, the motor 3680 can be further directed as to the
sequence in
which the multiple end effectors 3630 are moved or vibrated. Figure 50B
illustrates a
coupler 3650 positioned between each motor 3680 and certain end effectors 3630
to
facilitate the selective transmission of motion or vibration from the motor
3680 the
desired end effector or effectors 3630. A variety of methods, including
magnetic coupling
and mechanical coupling, can be used by the coupler to selectively transmit
motion or
vibration. For example, the end effectors 3630 can be coupled by selectively
activating
and electromagnet to draw in and connect a permanent magnet on the near end of
an end
effector 3630 to the coupler 3650. Then, reversing the polarity of the
electromagnet can
decouple the end effector 3630 and return it to its original position. In
another example
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depicted in Figure 50C, one of an array of grippers 5655 can grip the near end
of given an
end effector 3630 to enable transmission of motion or vibration and be
released to stop
the 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 a
layered configuration with connecting rods of varied lengths. This is an
advantage
because multiple motors can be arrayed in a comparatively small space and
transmit
vibration to a larger vibration member. Such an arrangement can also be
combined with a
stimulator, such as a vibratory motor, suspended within the suction chamber.
Alternatively, the multiple motors can be layered and/or configured such that
they
transmit vibration to at a comparatively higher resolution. That is, the
motors can
communicate via rods, for example, to a vibratory element whose footprint is
comparatively smaller than the footprint of the motor configuration. Further,
the vibratory
element 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 a
stimulating member having an array of projections. That is, some prior art
devices simply
shake an entire array of projections rather than providing a series of
transmission point
that efficiently 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
the
stimulating and/or suction chamber such that the motors are contained in a
separate
housing. The motors can transmit vibration to the site of stimulation via a
cable or rod
assembly or other similar member. The motor housing can be mounted on a
garment or
other wearable item. Or, the motor housing can be placed nearby the user
without actually
being worn or held by the user.
[223] Figures 51A and 51B illustrate an embodiment in which a single motor
4050 can
drive a stimulation-coupling element 4000, which has areas of differing
rigidity. Rigid
areas of the stimulation-coupling element 4000 can vibrate harmonically or
resonantly
with the motor 4050. Thus, a single motor 4050 can drive spatially
differentiated
vibratory stimulation.
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[224] The stimulation-coupling element 4000 can be a network of comparatively
rigid
nodes 4010 connected by comparatively rigid spokes 4020. The stimulation-
coupling
element 4000 can also have less rigid regions 4030 that help isolate the
vibration to the
nodes. That is, the presence of less rigid regions 4030 serves to help
spatially differentiate
the areas that are vibrating in resonance or harmony with the drive motor
4050.
[225] Alternately, the nodes 4010 can include passive actuators that can
couple with the
drive motor to provide spatially differentiated stimulation. A passive
actuator can include
piston 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 node
4010 to the drive motor 4050. In some embodiments, passive actuators at nodes
4010 can
be selectively controlled by activating or deactivating local dampers. For
example,
passive actuators have selectively addressable locking mechanisms. Such
mechanisms
can be electronically controlled by the device controller block that provides
patterns for
spatially 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 to
a user's body. In some embodiments, the tissue chamber is configured to fit
under the
labia 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 the
device. For example, adhesives (such as gummy, sticky, or otherwise tacky
materials) can
be applied to the tissue flange on the device. Still further, flexible wings
294, as depicted
in Figure 52C, can be detachably present on the device body 210 (as seen from
the
bottom), 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 with
multiple attachable and disposable adhesive wings 294. For many users, it is
preferable to
apply 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 the
use of lateral projections 292 on the sides of the device 200 as depicted in
Figure 52A in
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cross-section. Such lateral projections 292 complement the tissue flange 225
that extends
below the labia majora. The lateral projections 292 can be resilient and
flexible to
facilitate placement. Further, the lateral projections 292 can be configured
to bend or snap
into place after placement of the tissue flange 225 under the labia majora.
The lateral
projections 292 can be configured to transmit vibration to the labia majora
for users
interested in such supplemental stimulation. Alternately, the device can
include soft clips
for attaching the device to the labia majora.
[228] Still another method for providing secure and comfortable attachment is
through
the use of soft and comparatively compliant extensions 293 attached to the
inferior
portion of the device 200, as depicted in Figures 52B (as seen from below) and
52D (an
isometric view). These inferior extensions 293 are configured to extend under
the labial
fold and press laterally to stabilize the device 200. The extensions 293 can
be resilient
and 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 4160
coupled to a clitoral stimulation device 4110. The intravaginal unit 4160 can
deliver
stimulation, including all the types of stimulation disclosed herein.
Additionally or
alternatively, the intravaginal unit 4160 can house any of the components of
the system
disclosed herein. Alternatively, intravaginal unit 460 can be passive and act
as a unit to
provide additional compression/stabilization of the clitoral stimulation
device 4110. For
example, in some embodiments the intravaginal unit 4160 includes a motor that
is
coupled to stimulating elements within the clitoral stimulation device 4110.
The motor
can be configured to provide both intravaginal vibration and clitoral
stimulation by
transmitting vibration through the stimulating elements. A transmission
element, such as
a cable, connects the motor in the intravaginal unit 4160 with the clitoral
stimulation
device 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
stimulation
device can be a "C" shaped connecter 4150, which is configured to provide a
secure and
comfortable fit. For example, the connector 4150 could be reversibly
deformable or it
could be capable of flexing open and closed to return to an original position.
The
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connector 4150 can be formed from a resilient or malleable wire encased in a
protective
cover. The connector can have a hinge point 4155 to facilitate placement. The
intravaginal unit 4160 can be configured to vibrate or otherwise stimulate the
G-spot via a
stimulation source (such as a motor) located near where the unit 4160 meets
the
connector 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 the
clitoral stimulation device. In such embodiments, the intravaginal unit can
communicate
by near-field radiofrequency technology or other interdevice communication
methods. In
such embodiments in which the intravaginal unit is not physically connected to
the
clitoral 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 or
resonating 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 soft
clip can be driven to provide stimulation by the intravaginal unit. In one
embodiment, the
soft clip contains permanent or electromagnets that can be driven to squeeze
together and
come apart to provide stimulation to clitoral tissue. An intravaginal unit or
a separate unit
can provide the external 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 device
4500 in these embodiments is placed in the space between the labia such that
the center of
mass of the device is farther inferior than other embodiments described herein
in which a
significant portion of the device rests on the mons. One advantage of this
embodiment is
that the weight of the device is somewhat inferior to the clitoris and
therefore can provide
secure and comfortable attachment. The device may partially obstruct the
urethra and/or
the vaginal opening. The device can be configured to take advantage of its
location and
employ any of the intravaginal unit embodiments described herein. Another
advantage of
this embodiment is that the stimulators 4580 can directly contact the clitoris
without
relying 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,
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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
of
expanding. 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 and
optionally expands to further capture tissue and to present tissue to
stimulating elements,
such as vibratory motors. In these embodiments, the vibratory motors can be
located
outside the suction chamber, as opposed to being suspended with the suction
chamber.
Further, clitoral and/or vulvar tissue may be gently squeezed towards the
stimulating
elements in addition to, or instead of, being drawn by suction towards the
stimulating
elements. 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 can
manually manipulate the chamber to squeeze tissue. In another example, the
suction
chamber 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 configured
differently
than a conventional voice coil are used. For example, planar magnetic
transducers can be
used as actuators to deliver stimulation to clitoral and/or vulvar tissue.
Planar magnetic
transducers can provide direct mechanical stimulation via a diaphragm or
membrane that
directly 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
printed
circuit spread across the surface of a thin-film substrate and a magnetic
array. The
magnetic array creates a magnetic field parallel to the diaphragm. The thin
diaphragm is
highly 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 is
positioned and configured to stimulate clitoral and/or vulvar tissue. An
electromagnetic
array can be positioned above the membrane to drive specific magnets and
create
spatially differentiated stimulation. That is, selective activation of the
electromagnetic
array can drive individual or groups of embedded magnets. Alternatively,
instead of an
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electromagnetic array, one or more moveable permanent magnets can be used to
selectively drive individual or groups of embedded magnets. The permanent
magnet can
be moved by a variety of mechanical or electromechanical means and according
to
various programmable or pre-programmed patterns.
[238] In certain embodiments, the system includes a vacuum reservoir. That is,
the
system includes a chamber that is capable of holding negative pressure that
can be
applied to the suction chamber of the device through a valve system. During
initial
attachment, after achieving the desired level of suction in the suction
chamber, such as
with an on-board pump, the vacuum source continues to run to supply the vacuum
reservoir with excess negative pressure. The on-board pump can stop running,
and if a
small leak develops the negative pressure in the vacuum reservoir can supply
suction to
the suction chamber until it is exhausted, and then the pump can turn back on
to replenish
the reservoir and suction chamber and then stop running again. One advantage
of the
vacuum 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 the
user and/or feedback to the device control systems. Sensed parameters include
tissue
temperature, tissue impedance, blood flow, tissue turgidity and/or
engorgement, heart
rate, and blood pressure. The data can be represented on the user control
device, such as a
smartphone. The data can be represented graphically and/or numerically and can
be
mapped over a visual representation of the anatomy. In a sense, the displayed
data can be
an "arousal meter" that provides information to the user. Further, the state
of the user's
arousal can be used to provide a biofeedback loop to control the device. For
example, the
user can set an arousal level on the device prior to use and the device can
monitor the
user'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
vibratory
motors. One style of actuator is a linear actuator in which a member is driven
back and
forth. 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
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linear actuators involve electromagnets and passive magnets arranged in a
piston-type
configuration to create linear motion.
[241] 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 a
reservoir is charged with compressed gas (including air) by a pump. The pump
can be a
manual pump such as a bellows or a syringe pump. The linear drive element of
the
pneumatic actuator can be biased in a first position and driven to a second
position by a
burst 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 to
generate stimulating forces. For example, various types of thermomechanical
and
thermoelectric actuators can be used to drive stimulating elements in a
device. Such
actuators include those that use thermoelectricity to expand a fluid, and such
fluid
expansion can drive a mechanical element (a piston, for example). Other
thermoelectric
actuators that are useful in some embodiments include shape memory alloys,
such as
nitinol, which can be used to produce mechanical motion when
thermoelectrically 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) to
produce tactile and/or kinesthetic sensations and forces. The rate and volume
of the puffs
of air can be varied to produce a variety of stimuli. Multiple ports for
delivery of puffs of
air can be used to achieve spatially differentiated stimulation of clitoral
and/or vulvar
tissue. Multiple ports can be configured using a valve and port array that
delivers air from
one or more pneumatic sources. Alternately, an array of pneumatic sources can
be used.
[244] In some embodiments, circulating air can be used to provide stimulation.
As with
the pulsed or puffs of air, a pneumatic source or sources can deliver air
through a valve
and port system. In contrast to the pulsed air system, a circulating air
system can be used
to stimulate tissue by blowing across tissue rather than pulsing against
tissue. Certain
embodiments 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,
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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 some
embodiments 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
differentiated
locations. Alternately, multiple and separately controlled suction sources can
be used in
conjunction 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
apply
therapeutic energy to clitoral and/or vulvar tissue, such as light energy or
electromagnetic
energy. 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
provide
ambient sounds via the device or system. Ambient sounds can be soundscapes
that
promote feelings of well-being and/or arousal in the user. Additionally, the
ambient
sound can be a "white noise" that provides a relatively constant background
sound and
thereby 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, it
will be understood by those skilled in the art that various changes may be
made and
equivalents may be substituted without departing from the scope of the
invention. In
addition, many modifications may be made to adapt a particular situation or
material to
the teachings of the invention without departing from its scope. Therefore, it
is intended
that 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.
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