The invention relates in general to the field of peripheral nerve evaluation and in particular to intra-vaginal nerve evaluation.
Recent research has shown that one cause of lack of female sexual satisfaction is a paucity of blood flow to the female sex organs. Common types of (organic) female sexual dysfunction include: discomfort during sexual intercourse, dryness, increased time for arousal, diminished ability to reach orgasm and diminished clitoral sensation. A recently marketed pharmaceutical, sold under the name xe2x80x9cViagraxe2x80x9d, solves a similar problem of impotence in men, by increasing the flow of blood to the male sex organs. As a prelude to permitting this and other drugs for female sexual disorders, the FDA (Food and Drug Administration) requires comprehensive testing into the effects of such drugs. Thus, this and other known therapies for male sexual dysfunction are not currently being applied towards female sexual dysfunction.
In general, the field of study of female sexual dysfunction lags far behind the study of male sexual dysfunction. For example, the following diagnostic tools are currently available for males with erectile dysfunction:
a) Home measurement of nocturnal erection.
b) Vascular tests, such as Doppler, Arteriography and erection causing pharmaceuticals.
c) Neurogenic tests, such as Biothesiometry (vibration stimulation) of the penile shaft, thermal testing of a penis and lower extremities, bulbacavernous reflex measurement and nerve conduction studies.
There exist several methods of measuring blood flow to the female sex organs, including an oxygenation temperature method and a vaginal pulse amplitude method, which utilizes a photoplethysmograph. However, these methods measure the result of sexual arousal (e.g., blood flow) and do not provide an objective measure of the sensitivity of the sex organs.
An object of some preferred embodiments of the invention is to provide a method and apparatus for measuring a sensitivity of female sex organs, especially of the vagina and/or the clitoris. In a preferred embodiment of the invention, the results of the measurement may be used to diagnose sexual dysfunction, to determine an appropriate pharmaceutical regiment and/or for research into cures for sexual dysfunction.
An aspect of some preferred embodiments of the invention relates to measuring various parameters of nervous sensitivity inside a vagina of a patient and/or at the clitoris of the patient. In a preferred embodiment of the invention, the nervous sensitivity is measured by subjecting a small part of the vagina to a stimulation and accepting feedback, preferably verbal, from the patient. Alternatively or additionally, the stimulation is applied simultaneously to a significant portion of the vagina, for example most of it, for example, by providing stimulation over the entire inserted surface of the probe. Preferably, one or more of the following four thresholds are determined: sensing threshold, pleasure threshold, pain threshold and tolerance threshold. In a preferred embodiment of the invention, physiological parameters may be determined at the part of the vagina, preferably simultaneously with the nervous sensitivity determination. Alternatively or additionally, a physical response of the part of the vagina to the stimulation may be measured, for example an increase in muscular tension or in blood flow. These physiological measurements may be used instead of or in addition to a patient feedback. In a preferred embodiment of the invention, one or more of the following stimuli are used: heat, cold, vibration, ultrasound, pressure and electric current.
An aspect of some preferred embodiments of the invention relates to mapping a response of the vagina and/or selecting a particular part of the vagina to be measured. In a preferred embodiment of the invention, measurements of physiological and/or nervous sensitivity parameters are performed for many parts of the vagina, covering a significant portion thereof. Alternatively or additionally, the measurements may be performed at external sex organs, such as the clitoris or the outer lips of the vagina. Alternatively or additionally to spatial mapping, the measurements may be repeated under various conditions, for example arousal levels, drugs, repetition and/or elapsed time.
An aspect of some preferred embodiment of the invention relates to a vaginal measurement probe which is adapted to match physiological parameters of the measurement task. In a preferred embodiment of the invention, a diameter and/or length of the probe is matched to the vagina and/or to a penile shaft of a regular partner of the patient. Alternatively or additionally, a cross-section of the probe is matched. Alternatively or additionally, an axial geometry variation of the probe, for example a bending in the probe is matched to a penil geometry. Alternatively or additionally, a surface temperature of the probe is controlled, for example matched to a penile surface temperature. Alternatively or additionally, a press profile of the probe, i.e., the level of pressure exerted by the probe against the vaginal structure is matched to a desired profile.
An aspect of some preferred embodiments of the invention relates to a female genital probe including a means, especially a base for maintaining a fixed spatial position of the relative to the female genitalia and/or for applying a desired amount of pressure against a stimulated area Preferably, the probe includes a spring or counter-weight for balancing the probe and/or for affecting a desired level of pressure. Alternatively or additionally, the probe may include a sensor for sensing physiological motion of the patent, such as caused by breathing. Thus, measurements by the probe may be synchronized, windowed and/or corrected for physiological motion.
An aspect of some embodiments of the invention relates to combining stimulation of male or female sex organs with functional imaging to assess the effect of the stimulation. Preferably, female sex organs are stimulated. In a preferred embodiment of the invention, the imaging is of the stimulated organ and/or a stimulated portion thereof. Preferably, blood flow imaging is used. Alternatively or additionally, Heat imaging is used. In a preferred embodiment of the invention, MRI imaging is used. Alternatively or additionally, ultrasonic imaging (from near the stimulated area or outside the body) is used. Alternatively or additionally to using imaging techniques, non-imaging techniques, such as known in the art of blood flow determination, may be used.
There is thus provided in accordance with a preferred embodiment of the invention, a vaginal probe system, comprising:
a shaft having a diameter of between 20 and 32 mm and adapted for insertion at least 5 mm into a human female genitalia; and
a stimulator comprising at least one stimulation area, said stimulation area being defined on only a portion on the shaft, said stimulator being configured to stimulate only a portion of the genitalia corresponding to said stimulation area
There is also provided in accordance with a preferred embodiment of the invention, a vaginal probe system, comprising:
a shaft adapted for insertion at least 5 mm into a human female genitalia; and
a vibration stimulator comprising at least one stimulation area, said stimulation area being defined on only a portion on the shaft, said stimulator being configured to stimulate only a portion of the genitalia corresponding to said stimulation area.
There is also provided in accordance with a preferred embodiment of the invention, a vaginal probe system, comprising:
a shaft adapted for insertion at least 1 mm into a human female genitalia;
a stimulator comprising at least one stimulation area, said stimulation area being defined on only a portion on the shaft, said stimulator being configured to stimulate only a portion of the genitalia corresponding to said stimulation area; and
means for urging said area against said portion, at a desired pressure level.
In a preferred embodiment of the invention, said stimulation comprises stimulation using heat. Alternatively or additionally, said stimulation comprises stimulation using cold. Alternatively or additionally, said stimulation comprises stimulation using vibration. Alternatively or additionally, said stimulation comprises stimulation using electrical current.
Alternatively or additionally, said stimulation area is adapted for contact with a clitoris. Preferably, the system comprises circuitry for activating said stimulation area to generate a sub-threshold stimulation level, which stimulation is below a normal sensitivity of a clitoris.
Alternatively or additionally, said stimulation area is adapted for contact with a portion of a vagina. Preferably, the system comprises circuitry for activating said stimulation area to generate a sub-threshold stimulation level, which stimulation is below a normal sensitivity of a vagina.
In a preferred embodiment of the invention, said stimulation area is adapted for contact with a portion of a lip of said genitalia.
In a preferred embodiment of the invention, said shaft is substantially cylindrical. Preferably, said shaft has a diameter of between 20 and 32 mm. Alternatively or additionally, said shaft has a diameter of between 23 and 30 mm. Alternatively or additionally, said shaft has a diameter of about 28 mm.
In a preferred embodiment of the invention, said shaft has a length of between 60 and 250 mm. Alternatively or additionally, said shaft has a length of between 80 and 130 mm. Alternatively or additionally, said shaft has a length of about 150 mm.
In a preferred embodiment of the invention, said shaft is adapted for insertion at least 20 mm into said genitalia. Alternatively or additionally, said shaft is adapted for insertion at least 40 mm into said genitalia. Alternatively or additionally, said shaft is adapted for insertion at least 60 mm into said genitalia. Alternatively or additionally, said shaft is adapted for insertion at least 100 mm into said genitalia.
In a preferred embodiment of the invention, said shaft comprises an inner probe portion and an outer hull. Preferably, said outer hull is flexible. Alternatively, wherein said outer hull is rigid.
In a preferred embodiment of the invention, the system comprises an actuator which moves said inner portion relative to said outer hull. Preferably, said actuator axially moves said inner hull. Alternatively or additionally, said actuator said actuator rotates said inner hull relative to said outer hull.
In a preferred embodiment of the invention, said outer hull is water tight.
In a preferred embodiment of the invention, the system comprises an extension which remains outside of said genitalia, when said shaft is inserted therein. Preferably, the system comprises a base coupled to said extension. Preferably, said base is weighted to stabilize said probe from moving out of position.
In a preferred embodiment of the invention, the system comprises means for attaching said extension to a patient comprising said genitalia.
In a preferred embodiment of the invention, the system comprises means for attaching said extension to a bed on which a patient comprising said genitalia is placed.
In a preferred embodiment of the invention, the system comprises an urging means for urging a portion of said stimulation area against said portion of said genitalia Preferably, said urging means comprises at least one counterweight. Alternatively or additionally, said urging means maintains a desired pressure on said stimulation area.
In a preferred embodiment of the invention, the system comprises an external controller for said system, which controls at least one parameter of the stimulation of at said stimulation area. Preferably, said at least one parameter comprises a stimulation duration. Alternatively or additionally, said at least one parameter comprises a stimulation intensity. Alternatively or additionally, said at least one parameter comprises a stimulation modality. Alternatively or additionally, said at least one parameter comprises a variation of a parameter over time. Alternatively or additionally, said at least one parameter comprises a delay between consecutive stimulations.
In a preferred embodiment of the invention, said controller includes an input for receiving a patient response to said stimulation. Preferably, said controller includes a memory for storing said input in association with stimulation parameters used to elicit said response. Alternatively or additionally, said controller modifies said at least one stimulation parameter, responsive to said input. Alternatively or additionally, said controller includes software for driving said stimulation area according to a nervous-sensitivity testing protocol. Preferably, said protocol is adapted to take into account an arousal level of said patient as a result of said stimulation.
In a preferred embodiment of the invention, said shaft is connected to said controller by wire. Preferably, said shaft is transmits data to said controller by wireless means.
In a preferred embodiment of the invention, said stimulation area is substantially square. Alternatively, said stimulation area is substantially round.
In a preferred embodiment of the invention, said stimulation area is at a side of said shaft. Alternatively, said stimulation area is at an end of said shaft. Alternatively, said stimulation area rings said shaft.
In a preferred embodiment of the invention, said stimulation area is flush with said shaft. Alternatively, said stimulation area protrudes from said shaft.
In a preferred embodiment of the invention, said stimulation area is less than 1500 mm square in area. Preferably, said stimulation area is less than 500 mm square in area Preferably, said stimulation area is less than 200 mm square in area. Preferably, said stimulation area is less than 70 mm square in area. Preferably, said stimulation area is less than 30 mm square in area. Preferably, said stimulation area is less than 10 mm square in area.
In a preferred embodiment of the invention, said at least one stimulation area comprises at least two separate stimulation areas on said shaft. Preferably, said separate areas can be independently activated to stimulate.
In a preferred embodiment of the invention, said at least one stimulation area comprises at least four separate stimulation areas on said shaft.
In a preferred embodiment of the invention, said at least one stimulation area comprises at least a ten separate stimulation areas on said shaft.
In a preferred embodiment of the invention, said shaft is sterilizable.
In a preferred embodiment of the invention, the system comprises at least one local physiological sensor on said shaft. Preferably, said sensor is a sensor which detects changes in blood flow. Alternatively or additionally, said sensor is adjacent said stimulation area.
In a preferred embodiment of the invention, said shaft includes an interior lengthwise channel from outside said body to said genitalia.
There is also provided in accordance with a preferred embodiment of the invention, a method for assessing a sensitivity of a female genitalia, comprising:
contacting a portion of said genitalia with a localized stimulator at a desired contact pressure;
activating said stimulator at least once to selectively stimulate said portion; and
determining at least one threshold of nervous sensitivity of said portion based on a patient response to said stimulation. Preferably, said patient response is determined by a conscious response of said patient. Alternatively or additionally, said patient response is determined by a autonomous response of said patient. Preferably, said autonomous response is determined by measuring a change in blood flow responsive to said stimulation. Preferably, said blood flow change is determined by imaging at least a portion of said genitalia.
In a preferred embodiment of the invention, said blood flow change is determined by imaging at least a portion of a brain of said patient. Alternatively or additionally, said blood flow change is determined by a sensor in contact with the stimulated area.
In a preferred embodiment of the invention, said desired contact pressure is maintained over said at least one activation of said stimulator.
In a preferred embodiment of the invention, said desired contact pressure is intentionally varied for different parts of said genitalia.
In a preferred embodiment of the invention, the method comprises varying a delay between subsequent activations responsive to said patient response.
In a preferred embodiment of the invention, said threshold comprises a sensation threshold. Alternatively or additionally, said threshold comprises a pain threshold. Alternatively or additionally, said threshold comprises a pleasure threshold. Alternatively or additionally, said threshold comprises a comfort threshold.
In a preferred embodiment of the invention, the method comprises varying at least one parameter of said activation for different activations of the same portion. Preferably the method comprises varying a duration of said activation. Alternatively or additionally, the method comprises varying an intensity of said activation. Alternatively or additionally, the method comprises varying a stimulation modality of said activation.
In a preferred embodiment of the invention, the method comprises varying at least one parameter of said activation for activations of different portions. Preferably, said varying comprises replacing said probe with a different probe. Preferably, said probes are exchanged while maintaining a same holder in a same relative position to said genitalia.
In a preferred embodiment of the invention, the method comprises repeating said selectively stimulating and said determining for a plurality of portions of said genitalia. Preferably, the method comprises generating a threshold map of a portion of said genitalia.
In a preferred embodiment of the invention, said portion comprises a portion of a vagina Alternatively or additionally, said portion comprises at least a portion of a clitoris.
In a preferred embodiment of the invention, selectively stimulating comprises inserting a stimulator into said genitalia.
In a preferred embodiment of the invention, determining comprises selectively stimulating said portion at a plurality of stimulation levels. Preferably, said determining comprises determining using a limits method.
In a preferred embodiment of the invention, selectively stimulating comprises maintaining a background stimulation of at least another part of said genitalia. Preferably, said at least another part comprises substantially all of a vagina of said genitalia.
There is also provided in accordance with a preferred embodiment of the invention, a method for assessing a sensitivity of a female genitalia, comprising:
contacting at least portion of said genitalia with a stimulator;
activating said stimulator at least once to stimulate at least said portion; and
determining at least one threshold of nervous sensitivity of said portion based on an autonomous response to said stimulation. Preferably, said stimulating is restricted to said portion. Alternatively or additionally, said determining is by imaging of said genitalia.
In a preferred embodiment of the invention, the method comprises repeating said stimulating in a pattern which models a sequence of activities in a sex act.
USPTO Backgrounds
USPTO Backgrounds