Device for diagnosing and relieving female incontinence

Claim 1

A device for relieving or diagnosing incontinence in a women, comprising: an inflatable elongate body having proximal and distal ends that is very generally shaped and sized for insertion into such woman's vagina, the proximal end being adapted to be placed adjacent to such woman's cervix; and means, permanently attached to the elongate body, for adjustably inflating the elongate body and for sealing it to maintain the inflation over at least many hours so as to: laterally engage the vagina to retain the elongate body therein for at least many hours, and longitudinally distend the vagina and with it such woman's urethra; the elongate bady having, at least when inflated within the vagina, indentation means for receiving such woman's cervix while the elongate body extends into and distends the most proximal portion of the vagina posterior to the cervix; the indentation means being being disposed near the proximal end of the elongate body, facing generally proximally, and sized to receive such woman's cervix; and the inflating and sealing means being adapted for such womans to carry, in or near her vagina and attached to the elongate body, while she pursues normal daily activities; whereby the urethra is elongated, and such woman's bladder neck and proximal portion of the urethra are moved toward normal intraabdominal positions, when the device is inflated within the vagina.

Claim 2

A device for relieving or diagnosing incontinence in a women, comprising: an inflatable elongate body having proximal and distal ends that is very generally shaped and sized for insertion into such woman's vagina, the proximal end being adapted to be placed adjacent to such woman's cervix; and means, permanently attached to the elongate body, for adjustably inflating the elongate body and for sealing it to maintain the inflation over at least many hours so as to: laterally engage the vagina to retain the elongate body therein for at least many hours, and longitudinally distend the vagina and with it such woman's urethra; the elongate bady having, at least when inflated within the vagina, indentation means for receiving such woman's cervix while the elongate body extends into and distends the most proximal portion of the vagina posterior to the cervix; the indentation means being being disposed near the proximal end of the elongate body, facing generally proximally, and sized to receive such woman's cervix; and the inflating and sealing means being adapted for such womans to carry, in or near her vagina and attached to the elongate body, while she pursues normal daily activities; whereby the urethra is elongated, and such woman's bladder neck and proximal portion of the urethra are moved toward normal intraabdominal positions, when the device is inflated within the vagina.

Claim 30

A method for relieving or diagnosing incontinence in a woman, comprising the steps of: inserting into such woman's vagina an inflatable elongate body that is very generally shaped and sized to fit within the vagina, and that has, at least when inflated within the vagina, an indentation near the proximal end of the elongate body to receive such woman's cervix while the elongate body extends into and distends the most proximal portion of the vagina posterior to the cervix; said inserting step including orienting the elongate body so that at least upon inflation thereof the indentation will receive such woman's cervix while the elongate body extends into and distends the most proximal portion of the vagina posterior to the cervix; then adjustably inflating the elongate body while maintaining the orientation thereof so that the indentation receives such woman's cervix while the elongate body extends into and distends the most proximal portion of the vagina posterior to the cervix; sealing the elongate body to maintain the inflation over at least many hours, so that the elongate body: laterally engages the vagina to retain the elongate body therein, and longitudinally distends the vagina and with it such woman's urethra, and moves such woman's bladder neck and proximal portion of her urethra toward normal intraabdominal positions; and then leaving the elongate body so inflated within the vagina over at least many hours.

Claim 31

A method for relieving or diagnosing incontinence in a woman, comprising the steps of: inserting into such woman's vagina an inflatable elongate body that is very generally shaped and sized to fit within the vagina, and that has, at least when inflated within the vagina, an indentation near the proximal end of the elongate body to receive such woman's cervix while the elongate body extends into and distends the most proximal portion of the vagina posterior to the cervix; said inserting step including orienting the elongate body so that at least upon inflation thereof the indentation will receive such woman's cervix while the elongate body extends into and distends the most proximal portion of the vagina posterior to the cervix; then adjustably inflating the elongate body while maintaining the orientation thereof so that the indentation receives such woman's cervix while the elongate body extends into and distends the most proximal portion of the vagina posterior to the cervix; sealing the elongate body to maintain the inflation over at least many hours, so that the elongate body: laterally engages the vagina to retain the elongate body therein, and longitudinally distends the vagina and with it such woman's urethra, and moves such woman's bladder neck and proximal portion of her urethra toward normal intraabdominal positions; and then leaving the elongate body so inflated within the vagina over at least many hours.

Claim 33

A method for relieving or diagnosing incontinence in a woman, comprising the steps of: inserting into such woman's vagina an inflatable elongate body that is very generally shaped and sized to fit within the vagina, and that has, at least when inflated within the vagina: an indentation near the proximal end of the elongate body to receive such woman's cervix while the elongate body extends into and distends the most proximal portion of the vagina posterior to the cervix, and at least a slight lateral enlargement which fits just above such woman's levator ani sling to help retain the elongate body within the vagina; then adjustably inflating the elongate body; and inflating the lateral enlargement to engage the levator ani sling, thereby facilitating retention of the elongate body within the vagina; sealing the elongate body to maintain the inflation over at least many hours, so that the elongate body: laterally engages the vagina to retain the elongate body therein, and longitudinally distends the vagina and with it such woman's urethra, and moves such woman's bladder neck and proximal portion of her urethra toward normal intraabdominal positions; and then leaving the elongate body and lateral enlargement so inflated within the vagina over at least many hours.

Claim 34

A method for relieving or diagnosing incontinence in a woman, comprising the steps of: inserting into such woman's vagina an inflatable elongate body that is very generally shaped and sized to fit within the vagina, and that has, at least when inflated within the vagina: an indentation near the proximal end of the elongate body to receive such woman's cervix while the elongate body extends into and distends the most proximal portion of the vagina posterior to the cervix, and at least a slight lateral enlargement which fits just above such woman's levator ani sling to help retain the elongate body within the vagina; then adjustably inflating the elongate body; and inflating the lateral enlargement to engage the levator ani sling, thereby facilitating retention of the elongate body within the vagina; sealing the elongate body to maintain the inflation over at least many hours, so that the elongate body: laterally engages the vagina to retain the elongate body therein, and longitudinally distends the vagina and with it such woman's urethra, and moves such woman's bladder neck and proximal portion of her urethra toward normal intraabdominal positions; and then leaving the elongate body and lateral enlargement so inflated within the vagina over at least many hours.

Claim 36

A method for relieving or diagnosing incontinence in a woman, comprising the steps of: inserting into such woman's vagina an inflatable elongate body that is very generally shaped and sized to fit within the vagina, and that has, at least when inflated within the vagina, an indentation near the proximal end of the elongate body to receive such woman's cervix while the elongate body extends into and distends the most proximal portion of the vagina posterior to the cervix; then adjustably inflating the elongate body; sealing the elongate body to maintain the inflation over at least many hours, so that the elongate body: laterally engages the vagina to retain the elongate body therein, and longitudinally distends the vagina and with it such woman's urethra, and moves such woman's bladder neck and proximal portion of her urethra toward normal intraabdominal positions; and then leaving the elongate body so inflated within the vagina over at least many hours; and wherein: the elongate body and a valve and fitting attached thereto for use in inflating or deflating the chamber, said valve being manually operable from the distal end of the elongate body while the elongate body is within the vagina; and the inflating step comprises affixing to the valve and fitting a source of compressed gas, while the elongate body is within the vagina, and supplying such gas from such source through the valve and fitting into the elongate body.

Claim 37

A method for relieving or diagnosing incontinence in a woman, comprising the steps of: inserting into such woman's vagina an inflatable elongate body that is very generally shaped and sized to fit within the vagina, and that has, at least when inflated within the vagina, an indentation near the proximal end of the elongate body to receive such woman's cervix while the elongate body extends into and distends the most proximal portion of the vagina posterior to the cervix; then adjustably inflating the elongate body; sealing the elongate body to maintain the inflation over at least many hours, so that the elongate body: laterally engages the vagina to retain the elongate body therein, and longitudinally distends the vagina and with it such woman's urethra, and moves such woman's bladder neck and proximal portion of her urethra toward normal intraabdominal positions; and then leaving the elongate body so inflated within the vagina over at least many hours; and wherein: the elongate body and a valve and fitting attached thereto for use in inflating or deflating the chamber, said valve being manually operable from the distal end of the elongate body while the elongate body is within the vagina; and the inflating step comprises affixing to the valve and fitting a source of compressed gas, while the elongate body is within the vagina, and supplying such gas from such source through the valve and fitting into the elongate body.

Claim 38

A method for relieving or diagnosing incontinence in a woman, comprising the steps of: inserting into such woman's vagina an inflatable elongate body that is very generally shaped and sized to fit within the vagina, and that has, at least when infalted within the vagina, an indentation near the proximal end of the elongate body to receive such woman's cervix while the elongaqe body extends into and distends the most proximal portion of the vagina posterior to the cervix; then adjustably inflating the elongate body; before or during the insertion step, or both, stiffening the elongate body while it is at least mostly deflated, to facilitate the insertion step; sealing the elongate body to maintain the inflation over at least many hours, so that the elongate body: laterally engages the vagina to retain the elongate body therein, and longitudinally distends the vagina and with it such woman's urethra, and moves such woman's bladder neck and proximal portion of her urethra toward normal intraabdominal positions; and then leaving the elongate body so inflated within the vagina over at least many hours.

Claim 39

A method for relieving or diagnosing incontinence in a woman, comprising the steps of: inserting into such woman's vagina an inflatable elongate body that is very generally shaped and sized to fit within the vagina, and that has, at least when infalted within the vagina, an indentation near the proximal end of the elongate body to receive such woman's cervix while the elongaqe body extends into and distends the most proximal portion of the vagina posterior to the cervix; then adjustably inflating the elongate body; before or during the insertion step, or both, stiffening the elongate body while it is at least mostly deflated, to facilitate the insertion step; sealing the elongate body to maintain the inflation over at least many hours, so that the elongate body: laterally engages the vagina to retain the elongate body therein, and longitudinally distends the vagina and with it such woman's urethra, and moves such woman's bladder neck and proximal portion of her urethra toward normal intraabdominal positions; and then leaving the elongate body so inflated within the vagina over at least many hours.

Claim 41

A method for relieving or diagnosing incontinence in a woman, and particularly for use in diagnosing such woman's previously reported symptoms of incontinence; said method comprising the steps of: inserting into such woman's vagina an inflatable elongate body that is very generally shaped and sized to fit within the vagina, and that has, at least when inflated within the vagina, an indentation near the proximal end of the elongate body to receive such woman's cervix while the elongate body extends into and distends the most proximal portion of the vagina posterior to the cervix; then adjustably inflating the elongate body; sealing the elongate body to maintain the inflation over at least many hours, so that the elongate body: laterally engages the vagina to retain the elongate body therein, and longitudinally distends the vagina and with it such woman's urethra, and moves such woman's bladder neck and proximal portion of her urethra toward normal intraabdominal positions; and then leaving the elongate body so inflated within the vagina over at least many hours; wherein said elongation of the urethra, and said moving of the bladder neck and proximal portion of the urethra toward normal intraabdominal positions, are generally sufficient to render the urethra capable of withstanding bladder pressures characteristic of anatomical incontinence, but not those characteristic of bladder instability; and also comprising the step of, after at least a protracted part of the leaving step, determining whether such previously reported symptoms of incontinence were relieved.

Claim 42

A method for relieving or diagnosing incontinence in a woman, and particularly for use in diagnosing such woman's previously reported symptoms of incontinence; said method comprising the steps of: inserting into such woman's vagina an inflatable elongate body that is very generally shaped and sized to fit within the vagina, and that has, at least when inflated within the vagina, an indentation near the proximal end of the elongate body to receive such woman's cervix while the elongate body extends into and distends the most proximal portion of the vagina posterior to the cervix; then adjustably inflating the elongate body; sealing the elongate body to maintain the inflation over at least many hours, so that the elongate body: laterally engages the vagina to retain the elongate body therein, and longitudinally distends the vagina and with it such woman's urethra, and moves such woman's bladder neck and proximal portion of her urethra toward normal intraabdominal positions; and then leaving the elongate body so inflated within the vagina over at least many hours; wherein said elongation of the urethra, and said moving of the bladder neck and proximal portion of the urethra toward normal intraabdominal positions, are generally sufficient to render the urethra capable of withstanding bladder pressures characteristic of anatomical incontinence, but not those characteristic of bladder instability; and also comprising the step of, after at least a protracted part of the leaving step, determining whether such previously reported symptoms of incontinence were relieved.