WO2014081600A1

WO2014081600A1 - Devices and methods for promoting female sexual wellness

Info

Publication number: WO2014081600A1
Application number: PCT/US2013/069949
Authority: WO
Inventors: Joshua Makower; II Earl BRIGHT; Sharon Lam Wang
Original assignee: ExploraMed NC6, LLC
Priority date: 2012-11-21
Filing date: 2013-11-13
Publication date: 2014-05-30

Abstract

A method of positioning a suction-generating device in contact with clitoral region tissue and adjusting the level of suction generated by the device over the clitoris without repositioning the device. A device configured to remain positioned in contact with clitoral region tissue and to provide substantially continuous suction without the need for hand-held positioning of the device.

Description

DEVICES AND METHODS FOR PROMOTING FEMALE SEXUAL WELLNESS

FIELD OF THE INVENTION

[001 ] Embodiments of the present invention relate generally to devices and methods and more particularly to promoting female sexual wellness. In particular, certain embodiments are useful for promoting, facilitating, stimulating, or enhancing sexual desire, arousal or satisfaction in a female.

BACKGROUND OF THE INVENTION

[002] 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, such as arteriosclerosis and diabetes, 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.

[003] An effective method of increasing clitoral engorgement is through use of suction. A partial vacuum placed over the clitoris creates negative pressure in the organ, which promotes clitoral arterial inflow and venous congestion and results in increased vascular engorgement and sexual arousal. One device for stimulating female sexual response that is designed to be applied in the clitoral region is described in U.S. Pat. No. 6,733,438. It consists of a suction-producing, partially deformable device (i.e., squeeze and release) of unitary construction having a distal tip portion, a flange and intermediate side walls which, when placed over the clitoris of the user, stimulates blood flow and sexual response. The intermediate side walls are outwardly convex so as to retain its shape rather than collapse when suction is produced by releasing the user-deformed tip portion. The side walls may be reinforced with internal or external arches. The arched geometry prevents side wall collapse and clitoral compression with injury.

[004] However, such squeeze-and-release type prior art devices may produce unpredictable amounts of suction and not provide variable suction adaptable to the physiology of individual users.

BRIEF SUMMARY OF THE INVENTION

[005] Certain embodiments of the present invention are related to a method for promoting female sexual arousal. The method includes positioning a suction- generating device in contact with clitoral region tissue and adjusting the level of suction generated by the device over the clitoris without repositioning the device. The device is configured to remain positioned in contact with clitoral region tissue and to provide substantially continuous suction without the need for hand-held positioning of the device.

[006] In certain embodiments, the device remains in position via the suction generated by the device. The level of suction may be reduced or increased after the device is positioned from a first level capable of maintaining the position of the device to a second level capable of maintaining the position of the device.

[007] In certain embodiments, the level of suction is adjusted by moving a plunger positioned within an interior space of the device. In certain embodiments, the level of suction is adjusted using a detachable suction tool.

[008] Certain embodiments of the present invention are related to a method for increasing blood flow to a clitoris. The method includes positioning a device about the clitoris and in sealing contact with vulvar tissue such that the clitoris is substantially within a suction chamber of the device. The method includes applying suction via the suction chamber to the clitoris, wherein the level of suction is adjustable. The method includes maintaining the position of the device without having to maintain contact between the device and the user's hand. In certain embodiments, the level of suction is repeatably adjustable without repositioning the device.

[009] Certain embodiments of the present invention are related to an apparatus for promoting female sexual arousal. The apparatus includes device having a body and a flange. The flange is configured to maintain sealing contact with vulvar tissue and the interior of the body defining a suction chamber. The device includes a plunger configured to travel within the suction chamber.

[010] Certain embodiments of the present invention are related to an apparatus for promoting female sexual arousal. The apparatus includes a device having a body and a flange. The flange is configured to maintain sealing contact with vulvar tissue and the interior of the body defining a suction chamber. The apparatus includes a suction tool in fluid connection with the suction chamber, the suction tool configured to apply repeatable levels of suction to the suction chamber.

BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS

[011 ] Figures 1 through 4 illustrate perspective views of various embodiments of the invention in which the suction chamber and the sealing flange have various configurations.

[012] Figures 5, 5A, and 6 illustrate vertical cross-sectional views of a clitoral engorgement device according to an embodiment of the invention, which includes a plunger capable of being manually actuated via a sliding connection to provide variable suction.

[013] Figures 7, 7A and 8 illustrate two vertical cross-sectional and a top view, respectively, of a clitoral engorgement device according to an embodiment of the invention, which includes a plunger capable of being manually actuated via a threaded connection to provide variable suction.

[014] Figures 9, 10, and 1 1 illustrate a pair of vertical cross-sectional views and a side view, respectively, of a clitoral engorgement device according to an embodiment of the invention, which includes a spring-loaded plunger capable of being manually triggered to provide variable suction.

[015] Figure 12 illustrates a perspective view of an apparatus according to an embodiment of the invention including a syringe and a clitoral engorgement device.

[016] Figures 13 and 13A illustrates a perspective view of a clitoral engorgement device according to an embodiment of the invention, which includes a bulb capable of being manually compressed to provide suction.

[017] Figures 14 and 15 illustrate vertical cross-sectional views of a clitoral engorgement device according to an embodiment of the invention, which includes interior stimulating features. Figure 15 illustrates stimulating features that can provide variable engagement with the clitoris.

[018] Figure 16 illustrates a magnified view of a section of the device of Figure 15 and depicts an embodiment of a means for providing the variable engagement of stimulating features.

[019] Figures 17 and 18 illustrate vertical cross-sectional views of a clitoral engorgement device according to an embodiment of the invention, which includes a deformable suction chamber.

DETAILED DESCRIPTION OF THE INVENTION

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

[021 ] Before the present devices and methods are described, it is to be understood that this invention is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims. [022] 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. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited.

[023] 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.

[024] 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.

[025] 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.

[026] 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. [027] Figure 1 illustrates a perspective view of a clitoral engorgement device according to an embodiment of the invention. Device 10 includes body 20, end 25, and flange 30. Body 20 is sized to fit over the clitoris. Flange 30 is configured to engage tissue. Preferably, flange 30 is configured to provide an airtight seal against anterior vulvar tissue, such as in the clitoral region. With an airtight seal against the anterior vulvar tissue, the device stays in place without being hand-held. Figure 1 illustrates body 20 as having a substantially cylindrical configuration. Flange 30 flares out from the opposite side of body 20 from end 25. Figure 1 illustrates flange 30 as having a diameter somewhat larger than the diameter of body 20.

[028] Referring still to Figure 1 , the diameter of body 20 may vary from about 1 .0 cm to about 3.5 cm. Preferably, the sealing surface of flange 30 contacts the anterior vulvar tissue adjacent to the outer perimeter of the glans clitoris. The height of device 10 may vary from about 1 .5 cm to about 3.0 cm. Preferably, the height of device 10 is between about 2.0 cm and about 2.5 cm. More preferably, the height of device 10 is approximately 2.0 cm. The device is configured to fit comfortably under the labia majoria without excessive protrusion yet should also be accessible for handling and adjustment. As illustrated in Figure 1 , flange 30 may have a diameter on the order of a few to several millimeters larger than the diameter of body 20.

[029] Figure 2 illustrates a perspective view of an embodiment of the invention in which body 20 has a greater height and flange 30 has a greater diameter than depicted in Figure 1 . As in Figure 1 , body 20 of Figure 2 has a substantially cylindrical configuration starting from end 25 and continuing to a portion of body 20 near flange 30. The portion of body 20 near flange 30 tapers outwardly. Notably, the substantially cylindrical configuration of body 20 in the embodiments depicted in Figures 1 and 2 provides a substantially cylindrical suction chamber in the interior of body 20 that is particularly suited for certain suction-providing mechanisms further described herein.

[030] Figure 3 illustrates a perspective view of an embodiment of the invention in which body 20 has a tapered configuration as compared to the substantially cylindrical configuration of the embodiments of Figures 1 and 2. According to embodiments such as that depicted in Figure 3, body 20 may have a frusto-conical configuration. The frusto-concial configuration of body 20 may taper outwardly symmetrically or asymmetrically about its central axis. Further, body 20 may taper linearly or non-linearly from end 25 to the portion near flange 30.

[031 ] Figure 4 illustrates a perspective view of an embodiment of the invention in which body 20 has a tapered configuration as compared to the substantially cylindrical configuration of the embodiments of Figures 1 and 2. In the embodiment of Figure 4, the diameter of flange 30 is substantially larger than the initial diameter of body 20 near end 25.

[032] The tapered configurations depicted in Figures 3 and 4 may provide improved fit and/or comfort when positioned under the labia majora as compared to the substantially cylindrical configurations depicted in Figures 1 or 2. Further, the suction chamber in the interior of body 20 in the tapered configurations depicted in Figures 3 and 4 may be substantially cylindrical regardless of the non-cylindrical and optionally radially asymmetric configuration of body 20. Such a substantially cylindrical configuration of the suction chamber is particularly suited for certain suction- providing mechanisms further described herein. However, it is understood that certain suction-providing mechanisms further described herein are suitable for use with suction chambers with non-cylindrical configurations. The cross-sections of embodiments depicted herein typically illustrate substantially cylindrical configurations for both the interior and exterior of body 20 of device 10, however, it is understood that all of such configurations, the exterior of body 20 may have such non-cylindrical configurations as described herein.

[033] The embodiments depicted in Figures 1 -3 depict device 10 as having a configuration such that body 20 is not orthogonal with flange 30. It is understood that the angle of body 20 with respect to flange 30 may vary. Advantageously, the angle of body 20 with respect to flange 30 may provide improved fit and/or comfort when positioned under the labia majora. Further, the angle of body 20 with respect to flange 30 may advantageously provide improved clitoral stimulation by providing contact and/or physical pressure as compared to an orthogonal body. Of course, it is understood that orthogonal configuration of the body 20 and flange 30 are also contemplated as certain embodiments of the invention.

[034] It is understood that the embodiments described herein in which body 20 is described as having a cylindrical configuration, or a frusto-conical configuration, may have various horizontal cross-sectional shapes, including circular or oval shapes. In some embodiments, an oval horizontal cross-section for body 20 may preferably provide improved clitoral stimulation by providing contact and/or physical pressure as compared to a circular horizontal cross-section. Similarly, flange 30 may have various horizontal cross-sectional shapes, including circular or oval shapes. In some embodiments, an oval horizontal cross-section for flange 30 may preferably provide an improved seal against anterior vulvar tissue as compared to a flange having a circular horizontal cross-section. In configurations of the device in which the body and/or the flange have a non-circular horizontal cross section, the diameter refers to the average diameter of such non-circular shape.

[035] Referring still to Figures 1 -4, body 20 is configured to include any embodiments of the suction chambers disclosed in the figures and descriptions presented herein or equivalents of such embodiments. For example, the devices of Figures 1 -4 may have plunger-type suction chambers described herein. In another example, the devices of Figures 1 -4 may have syringe-type or bulb-type suction chambers as described herein. In yet another example, the devices of Figures 1 -4 may have displacement-type suction chambers described herein.

[036] In the embodiments described herein, plunger mechanisms, syringe mechanisms, bulb mechanisms, displacement mechanisms, and the equivalents of each type of mechanisms constitute adjustment mechanisms. According to embodiments of the invention, adjustment mechanisms may provide variable, repeatable, and relatively precise levels of suction. In certain embodiments, the adjustments mechanisms are present on, within, or as otherwise integral to the suction chamber. In certain embodiments, the adjustment mechanisms are coupled to the suction chamber.

[037] Figures 5 and 6 illustrate vertical cross-sections of a device 10 according to an embodiment of the invention, which includes a plunger 40 capable of being manually actuated via a sliding connection 45 to provide variable suction. Device 10 includes body 20 and flange 30. Body 20 and flange 30 may be made from different materials such that flange 30 is softer, more flexible, and/or more compliant than body 20. Flange 30 is configured to form a substantially airtight seal with anterior vulvar tissue and may need to flex to form such a seal.

[038] Referring still to Figures 5 and 6, body 20 includes suction chamber 22, which is dimensioned and configured to provide sufficient suction on the clitoris to promote, facilitate, stimulate, or enhance clitoral engorgement and/or sexual arousal in a female. It is believed that sufficient suction is in the range of about .3 inHg to about 10 inHg. The amount of suction is governed by the displacement of the suction chamber. Displacement refers to the volume of the suction chamber and the extent of the movement of the plunger inside the suction chamber.

[039] Figure 5 depicts plunger 40 in a configuration prior to application of device 10 to the clitoris and surrounding anterior vulvar tissue. Device 10 is placed such that flange 30 substantially surrounds the clitoris. Handle 47 can be pulled while flange 30 is kept in contact with anterior vulvar tissue. Handle 47 is connected to plunger 40 via sliding connection 45. As handle 47 is withdrawn, suction chamber 22 applies an increasing amount of suction to the clitoris. Subsequently, handle 47 can be pushed down to decrease the amount of suction on the clitoris. Handle 47 and/or sliding connection 45 may include teeth, may be rotatable within its withdrawing slot, or may have other similar mechanisms to provide a way to secure plunger 40 at a preferred position within suction chamber 22. Securing plunger 40 within suction chamber 22 prevents plunger 40 from recoiling back to its installation position and a resulting loss of suction. Further, end 25 may optionally include a one-way air valve such that the air in suction chamber between end 25 and plunger 40 may be forced out of end 25 but not allowed back in suction chamber 22.

[040] Figure 5A depicts another embodiment of a sliding plunger-type device. Body 20 of device 10 includes upper chamber 21 and suction chamber 22. Device 10 is placed such that flange 30 substantially surrounds the clitoris. Handle 47 can be pulled while flange 30 is kept in contact with anterior vulvar tissue. Handle 47 is connected to plunger 40 via sliding connection 45. As handle 47 is withdrawn, suction chamber 22 applies an increasing amount of suction to the clitoris. Subsequently, handle 47 can be pushed down to decrease the amount of suction on the clitoris. Handle 47 and/or sliding connection 45 may include teeth, may be rotatable within its withdrawing slot, or may have other similar mechanisms to provide a way to secure plunger 40 at a preferred position within upper chamber 21 . Securing plunger 40 within upper chamber 21 prevents plunger 40 from recoiling back to its installation position and a resulting loss of suction. Further, end 25 may optionally include a one-way air valve such that the air in suction chamber between end 25 and plunger 40 may be forced out of end 25 but not allowed back in suction chamber 22.

[041 ] Figure 6 depicts device 10 in a configuration in which plunger 40 has been withdrawn to provide the maximum amount of suction. Body 20 is made from a material with sufficient rigidity to substantially maintain its shape under the force of suction applied by withdrawing plunger 40. In an alternate embodiment, handle 47 may include an eyelet through which a string is threaded. The string facilitates pulling plunger 40 and applying suction.

[042] Further, the interface between plunger 40 and the walls of suction chamber 22 is configured such that it provides a substantially airtight seal. The interior of suction chamber 22 and/or the edges of plunger 40 should provide a substantially airtight seal throughout the length of travel of plunger 40 within suction chamber 22. Such a seal may be provided by conventional means, such as an o-ring, biocompatible lubricant, interior flanges, and the like. [043] The embodiment depicted in Figures 5 and 6 can be removed by freeing handle 47 and/or sliding connection 45 from its secured configuration and sliding plunger 40 back towards flange to, thereby reducing the amount of suction and allowing the substantially airtight seal to be broken between flange 30 and the anterior vulvar tissue surrounding the clitoris. Alternately, the substantially airtight seal may be broken by directly disturbing the interface between flange 30 and the anterior vulvar tissue.

[044] Figure 7 depicts a vertical cross-section of a device 10 includes plunger 40 capable of being manually actuated via a threaded connection 44 to provide variable suction. As with the embodiments depicted in Figures 5 and 6, body 20 and flange 30 may be made from different materials to accommodate the different performance requirements of each. That is, flange 30 is softer, more flexible, and/or more compliant than body 20, and body 20 is sufficiently rigid to substantially maintain its shaped under the force of the applied vacuum. Figure 7 depicts plunger 40 in a configuration prior to application of device 10 to the clitoris and surrounding anterior vulvar tissue. In this embodiment, vacuum is applied by rotating knob 48. Knob 48 is formed with internal threads, such as by tapping, and these internal threads are complementary to external threads formed on threaded connection 44. Rotating knob 48 advances threaded connection 44, thereby pulling plunger 40 and applying suction within suction chamber 22. Knob 48 and threaded connection 44 are fabricated with sufficient rotational friction to secure plunger 40 at any point along its travel with respect to suction chamber 22. Sufficient rotational friction can be achieved through, for example, materials selection and thread pitch. It is understood that other embodiments including a threaded drive for advancing the plunger are also contemplated as certain embodiments of the invention.

[045] Figure 7A depicts another embodiment of a threaded plunger-type device. Device 10 includes plunger 40 capable of being manually actuated via a threaded connection 44 to provide variable suction. Knob 48 is formed with internal threads, such as by tapping, and these internal threads are complementary to external threads formed on threaded connection 44. Rotating knob 48 advances threaded connection 44, thereby pulling plunger 40 and applying suction within suction chamber 22. Knob 48 and threaded connection 44 are fabricated with sufficient rotational friction to secure plunger 40 at any point along its travel with respect to upper chamber 21 . Sufficient rotational friction can be achieved through, for example, materials selection and thread pitch. It is understood that other embodiments including a threaded drive for advancing the plunger are also contemplated as certain embodiments of the invention.

[046] Figure 8 depicts a top view of device 10 in which flange 30 has a generally oblong configuration and end 25 of body 20 has a substantially circular configuration. Again, the amount of suction is governed by the displacement of the suction chamber. The embodiment depicted in Figures 7 and 8 provide variable suction. As with the embodiments depicted in Figures 5 and 6, plunger 40 should maintain a substantially airtight seal within suction chamber 22. Further, end 25 may optionally include a one-way air valve.

[047] Figures 9 and 10 depict vertical cross-sectional views of device 10 including a spring-loaded plunger 40 capable of being manually triggered to provide variable suction. Similar to other plunger-type embodiments disclosed herein, body 20 includes plunger 40, which travels along suction chamber 22. In contrast to other plunger embodiments, end 25 of body 20 is open such that a user may push directly on plunger 40. Alternately, a user may use lever 41 to control the movement of plunger 40 as further described.

[048] As with other plunger-type embodiments, body 20 and flange 30 may be made from different materials to accommodate the different performance requirements of each. That is, flange 30 is softer, more flexible, and/or more compliant than body 20, and body 20 is sufficiently rigid to substantially maintain its shaped under the force of the applied vacuum. [049] Figure 9 depicts plunger 40 in a configuration prior to application of device 10 to the clitoris and surrounding anterior vulvar tissue. In this configuration, spring 60 is in a compressed configuration between plunger 40 and an interior lip on the portion of body 20 near flange 30. It is understood that other means of retaining spring within body 20 and in opposition to plunger 40 are also contemplated as certain embodiments of the invention. Figure 9 depicts optional protective membrane 80 in a relaxed configuration. Protective membrane 80 is permeable to air such that suction may be applied through it and is extremely flexible, compliant, and or distensible. Protective membrane 80 functions to limit the interaction of the clitoris with spring 60. Other means of retaining spring within body 20 and in opposition to plunger 40 may not require the use of protective membrane 80. Further, as further discussed herein, contact between the clitoris and spring 60 may be desirable to provide physical stimulation.

[050] Figure 10 depicts device 10 in a suction-providing configuration. Plunger 40 is near end 25 of body 20 and is being held in place there by spring 60, which is in an extended configuration. Optional protection membrane 80 is shown as being displaced by the clitoris, which is not pictured. Again, the amount of suction is governed by the displacement of the suction chamber. Plunger 40 should maintain a substantially airtight seal within suction chamber 22.

[051 ] Figure 1 1 illustrates a side view of the device of the embodiment of Figures 9 and 10. Figure 1 1 depicts one mechanical means of providing variable suction in an embodiment including a spring-loaded plunger. Lever 41 resides in track 70, and track 70 is configured with a series of detents that allow a user to select an amount of travel for plunger 40. Selecting the amount of travel of plunger 40 governs the amount of suction applied by device 10, as discussed herein with regard to the other plunger-type embodiments. A user can control the motion of plunger 40 by manually moving lever 40 or by slightly rotating plunger 40 when directly pressing it with a finger. [052] It is understood that many mechanical means may be used to secure and unlock plunger 40 and allow spring 60 to push plunger 40 along suction chamber 22. Such other mechanical means are also contemplated as certain embodiments of the invention.

[053] Figure 12 illustrates a perspective view of an apparatus according to an embodiment of the invention including syringe 100 and a suction device 10. In this embodiment, syringe 100 is a conventional syringe with fitting 105, for example, a Luer type fitting, on its end. Of course, other fitting ends are also contemplated as certain embodiments of the invention. Device 100 includes port 27, which is complementary to fitting 105. Preferably, port 27 includes a one-way valve or other means of maintaining vacuum created by syringe 100.

[054] Referring still to Figure 12, device 10 can be connected to syringe 100 prior to or after installation of device 10 about the clitoris. The plunger of syringe 105 is withdrawn to provide suction. The interior of body 20 can be hollow such that syringe 105 is used to create the suction directly. Alternatively, the interior of body 20 can contain a plunger-type configuration such that syringe 100 pulls air from the space between end 25 and the plunger within the body. One advantage of using syringe 100 to directly apply vacuum is that the mechanical means of securing the plunger within the suction chamber of device 10 may not be necessary.

[055] The syringe and suction device system, like other embodiments described herein, provides controlled and variable amounts of suction.

[056] Figures 13 and 13A illustrates perspective views of device 10 including bulb 90 capable of being manually compressed to provide suction. Body 20 is in fluid communication with bulb 90. Like the syringe and suction device system, bulb 90 in the embodiment depicted in Figure 13 provides suction to the interior of device 10. The interior of body 20 can be hollow such that bulb 90 is used to create the suction directly. Alternatively, the interior of body 20 can contain a plunger-type configuration such that bulb 90 pulls air from the space between end 25 and the plunger within the body.

[057] Figures 14 and 15 illustrate vertical cross-sectional views of 10 device including interior stimulating features 50. Stimulating features 50 may be formed from the same materials as body 20 or they may be formed from a different material. Stimulating features 50 provide physical contact with the clitoris and may further promote, facilitate, stimulate, or enhance sexual arousal in conjunction with suction applied through any of the embodiments disclosed herein.

[058] Figure 15 illustrates an embodiment in which the extent of physical contact by stimulating features 50 can be controlled. Stimulating features 50 are integral with push button 52 and moving push button 52 toward body 20 of device 10 increases the penetration of stimulating features 50 within suction chamber 22. Figure 16 depicts a magnified view of a section A of Figure 15 and illustrates one mechanical means of providing variable penetration of stimulating features 50 within suction chamber 22. This combination of a toothed edge of push button 52 and tab on stimulating feature 50 with springs 55 provides action similar to the spring-loaded plunger to enable variable positioning of the stimulating features.

[059] Figures 14 through 16 depict embodiments that may preferably be used with the syringe-type or bulb-type embodiments described above or the displacement- type embodiments described below. Certain plunger-type designs may also be suitable for use with the embodiments depicted in Figures 14 through 16 provided that the stimulating features of these embodiments do not substantially interfere with the ability of the plunger to create suction within the suction chamber.

[060] Figures 17 and 18 illustrate vertical cross-sectional views of a clitoral engorgement device 10, which includes a body 20 having an upper chamber 21 and a suction chamber 22. Flange 30 provides a seal between vulvar tissue and suction chamber 22, which is resiliently deformable. Figure 17 depicts device 10 in a first configuration in which the exterior of suction chamber 22 is in a non-deformed position. Device 10 has a volume equal to the interior volume of body 20, which in turn is the sum of the volume of upper chamber 21 and the volume of suction chamber 22. In the first configuration, the volume of body 20 is at a maximum since both upper chamber 21 and suction chamber 22 are at their maximum volume.

[061 ] Figure 18 depicts a second configuration in which upper chamber 21 has been moved towards flange 30, thereby deforming suction chamber 22. As suction chamber 22 is deformed by the movement of upper chamber 21 , the volume of body 20 is reduced. Device 10 is placed in contact with vulvar tissue, and preferably about the clitoris, in this second configuration with upper chamber 21 held in place towards flange 30. After device 10 is positioned, upper chamber 21 is released and the resilience of suction chamber 22 allows device 10 to resume, nearly resume, or somewhat resume, the first configuration. The volume displacement between the second configuration and the first configuration produces suction on the vulvar tissue under device 10.

[062] Optionally, the device depicted in Figures 17 and 18 can include a deformable upper chamber 21 . In this embodiment, upper chamber 21 can be deformed in addition to being moved towards flange 30, which in turn deformed suction chamber 22. In this embodiment, the total suction applied by device 10 can be varied between the amount of suction generated by only deforming suction chamber 22 and the amount of suction generated by deforming both suction chamber 22 and upper chamber 21 .

[063] According to embodiments of the invention, clitoral engorgement devices may be released from tissue by different means. As described herein, the plunger or other suction-generating system, such as a syringe or a bulb, may be reversibly actuated such that it reduced the suction in the suction chamber. With less suction applied to vulvar tissue, the device may be removed by pulling or laterally translation relative to the tissue surface. As described herein, the device may also be removed by breaking the seal at the edge of the flange to reduce suction and allow for easier device removal. In other embodiments, the body of the device may be squeezed or pressed laterally together to help break the suction seal or to alter the suction sufficiently to allow for easier device removal.

[064] An advantage of certain devices and methods of the present invention as described in detail herein is that these devices are capable of applying variable amounts of suction. The user can more precisely control the amount of suction force and tailor the use of the device to her individual physiology. The user can also first place the device in the desired location and then precisely control the amount of suction force desired. The user can alter precisely during a course of use the amount of suction force. For example, initially the user can draw a large amount of suction to encourage more rapid engorgement and then subsequently reduce the suction to a lower amount or vice versa without having to remove the device after it has been positioned. According to certain embodiments, a user can precisely control the applied suction in increments of about 0.25 inHg, in increments of about 1 .0 inHg, or in increments of about 2.0 inHg.

[065] According to certain embodiments, biocompatible substances may be applied to the device. For example, a tacky substance may be applied to the flange and/or the interior of the device body to enhance the seal between the flange and anterior vulvar tissue. In another example, a heat-generating substance may be applied to the flange and/or the interior of the device body to further promote, facilitate, stimulate, or enhance clitoral engorgement and/or sexual arousal.

[066] 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.

Claims

1 . A method for promoting female sexual arousal, comprising: positioning a suction-generating device in contact with vulvar tissue, the device comprising a flange and a suction chamber wherein the flange is more flexible than the suction chamber; and adjusting the level of suction generated by the device while maintaining contact between the device by moving a plunger positioned within an interior space of the suction chamber.

2. The method of claim 1 wherein the device remains in position via the suction generated by the device.

3. The method of claim 1 wherein the level of suction is reduced after the device is positioned from a first level capable of maintaining the position of the device to a second level capable of maintaining the position of the device.

4. The method of claim 1 wherein the level of suction is increased after the device is positioned from a first level capable of maintaining the position of the device to a second level capable of maintaining the position of the device.

5. The method of claim 1 wherein the level of suction generated by the device ranges from about .3 inHg to about 10 inHg.

6. The method of claim 1 wherein the level of suction generated by the device is less than about 10 inHg

7. The method of claim 1 wherein moving the plunger comprises sliding the plunger.

8. The method of claim 1 wherein moving the plunger comprises twisting the plunger.

9. The method of claim 1 where moving the plunger comprises releasing a biased plunger.

10. A method for increasing blood flow to a clitoris, comprising: positioning a device comprising a flange and a suction chamber about the clitoris and in sealing contact with vulvar tissue such that the clitoris is substantially surrounded by the flange; applying suction via the suction chamber to the clitoris, wherein the level of suction is adjustable using an adjustment mechanism integral to the suction chamber; and maintaining the position of the device without having to maintain contact between the device and the user's hand.

1 1 . The method of claim 10 wherein the position of the device is maintained for a period of time sufficient to increase blood flow to the clitoris.

12. The method of claim 10 wherein the level of suction is adjustable without repositioning the device.

13. The method of claim 10 wherein the level of suction is repeatably adjustable without repositioning the device.

14. The method of claim 10 wherein the level of suction is adjustable within increments of about 0.25 inHg, about 1 .0 inHg, or about 2.0 inHg.

15. The method of claim 10 further comprising releasing the device from its position in contact with vulvar tissue by controllably decreasing the level of suction in the suction chamber while maintaining sealing contact with vulvar tissue.

16. An apparatus for promoting female sexual arousal, comprising: a device comprising a body and a flange, the flange configured to maintain sealing contact with vulvar tissue and the interior of the body defining a suction chamber; and a plunger configured to travel within the suction chamber.

17. The apparatus of claim 16 wherein the plunger is configured to slidably travel within the suction chamber.

18. The apparatus of claim 16 wherein the plunger is configured to rotatably travel within the suction chamber.

19. The apparatus of claim 16 wherein the plunger is biased into a first position.

20. The apparatus of claim 16 further comprising a locking mechanism configured to limit the travel of the plunger.

21 . An apparatus for promoting female sexual arousal, comprising: a device comprising a body and a flange, the flange configured to maintain sealing contact with vulvar tissue and the interior of the body defining an upper chamber and a suction chamber; wherein the suction chamber is deformable.

22. The apparatus of claim 21 wherein the upper chamber is deformable.

23. The apparatus of claim 21 wherein the suction chamber is configured to deform as the upper chamber is moved along the vertical axis of the body towards the flange.