Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical energy applicator
Reexamination Certificate
2001-04-17
2004-05-25
Lacyk, John P. (Department: 3736)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical energy applicator
C600S038000
Reexamination Certificate
active
06741895
ABSTRACT:
FIELD OF THE INVENTION
The invention relates in general to the field of peripheral nerve evaluation and in particular to intra-vaginal nerve evaluation.
BACKGROUND OF THE INVENTION
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 “Viagra”, 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.
SUMMARY OF THE INVENTION
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
Cohen Aharon
Gafni Ehud
Fenster & Company
Lacyk John P.
Medoc Ltd.
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