Method and apparatus for tubal occlusion
First Claim
1. A method of occluding the ovarian pathway of a female body, wherein the ovarian pathway is lined by an epithelium layer on the inner surface of the ovarian pathway, and the lamina propria underlies the epithelial layer, and a layer of circular muscle underlies the lamina propria, and a layer of longitudinal muscle tissue underlies the circular muscle tissue, said method comprising the steps of:
- applying a catheter-mounted RF electrode array to a target segment of the ovarian pathway and operating the catheter-mounted RF electrode array to generate RF energy which causes a wound in the segment of the ovarian pathway that necroses the epithelial layer;
limiting the severity of the wound to avoid necrosis of the longitudinal muscle layer;
controlling the RF energy applied to the ovarian pathway by maintaining a temperature in the ovarian pathway in the range of 52-58°
C. for 40-60 seconds installing a foam plug comprising a reticulated foam into the wounded segment of the pathway; and
allowing the wounded segment of the pathway to heal with the foam plug installed.
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Accused Products
Abstract
Methods and devices for occlusion of the fallopian tubes of a women. The method involves thermally damaging the lining of the utero-tubal junction with relatively low power, followed by placement of a reticulated foam plug. In one embodiment, vascularized tissue grows into the plug and prevents or discourages formation of scar tissue around the plug. Another embodiment with a relatively small foam pore size encourages formation of a vascularized capsule around the plug. The presence of this vascularized capsule limits the patient'"'"'s foreign body response, so that the capsule does not constrict around the plug. Also presented is a catheter designed for wounding the epithelial layer of the utero-tubal junction, and a method of using the catheter to form a long yet shallow lesion in the utero-tubal junction.
332 Citations
6 Claims
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1. A method of occluding the ovarian pathway of a female body, wherein the ovarian pathway is lined by an epithelium layer on the inner surface of the ovarian pathway, and the lamina propria underlies the epithelial layer, and a layer of circular muscle underlies the lamina propria, and a layer of longitudinal muscle tissue underlies the circular muscle tissue, said method comprising the steps of:
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applying a catheter-mounted RF electrode array to a target segment of the ovarian pathway and operating the catheter-mounted RF electrode array to generate RF energy which causes a wound in the segment of the ovarian pathway that necroses the epithelial layer;
limiting the severity of the wound to avoid necrosis of the longitudinal muscle layer;
controlling the RF energy applied to the ovarian pathway by maintaining a temperature in the ovarian pathway in the range of 52-58°
C. for 40-60 secondsinstalling a foam plug comprising a reticulated foam into the wounded segment of the pathway; and
allowing the wounded segment of the pathway to heal with the foam plug installed.
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2. A method of occluding the ovarian pathway of a female body, wherein the ovarian pathway is lined by an epithelium layer on the inner surface of the ovarian pathway, and the lamina propria underlies the epithelial layer, and a layer of circular muscle underlies the lamina propria, and a layer of longitudinal muscle tissue underlies the circular muscle tissue, said method comprising the steps of:
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applying a catheter-mounted RF electrode array to a target segment of the ovarian pathway and operating the catheter-mounted RF electrode array to generate RF energy which causes a wound in the segment of the ovarian pathway that necroses the epithelial layer;
limiting the severity of the wound to avoid necrosis of the longitudinal muscle layer;
controlling the RF energy applied to the ovarian pathway by maintaining a temperature in the ovarian pathway at approximately 70°
C. for approximately 7 seconds;
installing a foam plug comprising a reticulated foam into the wounded segment of the pathway; and
allowing the wounded segment of the pathway to heal with the foam plug installed.
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3. A method of occluding the ovarian pathway of a female body, wherein the ovarian pathway is lined by an epithelium layer on the inner surface of the ovarian pathway, and the lamina propria underlies the epithelial layer, and a layer of circular muscle underlies the lamina propria, and a layer of longitudinal muscle tissue underlies the circular muscle tissue, said method comprising the steps of:
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applying a wounding element in the form of a catheter-mounted heating element and a catheter mounted temperature sensor positioned on the catheter in proximity to the heating element to a target segment of the pathway, and operating the wounding element to cause a wound in the segment of the pathway that necroses the epithelial layer;
limiting the severity of the wound created by the wounding element to avoid necrosis of the longitudinal muscle layer by applying heat to the ovarian pathway through the heating element, and limiting the severity of the wound by controlling the heating element to heat the ovarian pathway to a temperature range of 40-80°
C. as sensed by the temperature sensor, for a period of 5 to 60 seconds;
installing a foam plug comprising a reticulated foam into the wounded segment of the pathway; and
allowing the wounded segment of the pathway to heal with the foam plug installed.
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4. A method of occluding the ovarian pathway of a female body, wherein the ovarian pathway is lined by an epithelium layer on the inner surface of the ovarian pathway, and the lamina propria underlies the epithelial layer, and a layer of circular muscle underlies the lamina propria, and a layer of longitudinal muscle tissue underlies the circular muscle tissue, said method comprising the steps of:
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applying a catheter-mounted RF electrode array to a target segment of the ovarian pathway and operating the catheter-mounted RF electrode array to generate RF energy which causes a wound in the segment of the ovarian pathway that necroses the epithelial layer;
limiting the severity of the wound to avoid necrosis of the longitudinal muscle layer;
controlling the RF energy applied to the ovarian pathway by maintaining a temperature in the ovarian pathway in the range of approximately 40-80°
C. for approximately 5 to 60 seconds;
installing a foam plug comprising a reticulated foam into the wounded segment of the pathway; and
allowing the wounded segment of the pathway to heal with the foam plug installed.
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5. A method of occluding the ovarian pathway of a female body, wherein the ovarian pathway is lined by an epithelium layer on the inner surface of the ovarian pathway, and the lamina propria underlies the epithelial layer, and a layer of circular muscle underlies the lamina propria, and a layer of longitudinal muscle tissue underlies the circular muscle tissue, said method comprising the steps of:
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applying a wounding element in the form of a catheter-mounted heating element and a catheter mounted temperature sensor positioned on the catheter in proximity to the heating element to a target segment of the pathway, and operating the wounding element to cause a wound that necroses the epithelial layer in the segment of the pathway;
limiting the severity of the wound created by the wounding element to avoid necrosis of the longitudinal muscle layer by applying heat to the ovarian pathway through the heating element, and limiting the severity of the wound by controlling the heating element to heat the ovarian pathway to a temperature range of approximately 52-58°
C. as sensed by the temperature sensor, for a period of approximately 40-60 seconds;
installing a foam plug comprising a reticulated foam into the wounded segment of the pathway; and
allowing the wounded segment of the pathway to heal with the foam plug installed.
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6. A method of occluding the ovarian pathway of a female body, wherein the ovarian pathway is lined by an epithelium layer on the inner surface of the ovarian pathway, and the lamina propria underlies the epithelial layer, and a layer of circular muscle underlies the lamina propria, and a layer of longitudinal muscle tissue underlies the circular muscle tissue, said method comprising the steps of:
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applying a wounding element in the form of a catheter-mounted heating element and a catheter mounted temperature sensor positioned on the catheter in proximity to the heating element to a target segment of the pathway, and operating the wounding element to cause a wound that necroses the epithelial layer in the segment of the pathway;
limiting the severity of the wound created by the wounding element to avoid necrosis of the longitudinal muscle layer by applying heat to the ovarian pathway through the heating element, and limiting the severity of the wound by controlling the heating element to heat the ovarian pathway to a temperature of approximately 70°
C. as sensed by the temperature sensor, for a period of 7 seconds;
installing a foam plug comprising a reticulated foam into the wounded segment of the pathway; and
allowing the wounded segment of the pathway to heal with the foam plug installed.
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Specification