Method and apparatus for tubal occlusion
First Claim
1. A method of occluding the ovarian pathway of a female body, said method comprising the steps of:
- providing a device comprising a catheter body defining a proximal end and a distal end, a wounding segment extending distally from the distal end of the catheter body and movable relative to the catheter body between an extended position and a retracted position, a heating element disposed on or about the wounding segment, and at least one plug housed within the wounding segment and sized and dimensioned to be implanted into a target segment within the ovarian pathway;
inserting the catheter body and wounding segment into the ovarian pathway;
applying the heating element to a target segment of the pathway, and operating the heating element to heat the target segment; and
maintaining both the catheter body and at the least one plug stationary relative to the target segment while simultaneously (i) moving the wounding segment relative to the catheter body from the extended position toward the retracted position and (ii) exposing and implanting said stationary plug within the target segment of the pathway.
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Accused Products
Abstract
Methods and devices for occlusion of the fallopian tubes of a woman. 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.
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Citations
44 Claims
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1. A method of occluding the ovarian pathway of a female body, said method comprising the steps of:
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providing a device comprising a catheter body defining a proximal end and a distal end, a wounding segment extending distally from the distal end of the catheter body and movable relative to the catheter body between an extended position and a retracted position, a heating element disposed on or about the wounding segment, and at least one plug housed within the wounding segment and sized and dimensioned to be implanted into a target segment within the ovarian pathway; inserting the catheter body and wounding segment into the ovarian pathway; applying the heating element to a target segment of the pathway, and operating the heating element to heat the target segment; and maintaining both the catheter body and at the least one plug stationary relative to the target segment while simultaneously (i) moving the wounding segment relative to the catheter body from the extended position toward the retracted position and (ii) exposing and implanting said stationary plug within the target segment of the pathway. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A method of occluding the ovarian pathway of a female body, wherein the ovarian pathway is lined by an epithelial layer on the inner surface of the ovarian pathway, and wherein the ovarian pathway is further characterized by a lamina propria layer surrounding the epithelial layer, a circular muscle layer surrounding the lamina propria layer and a longitudinal muscle layer surrounding the circular muscle layer, said method comprising the steps of:
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providing a device comprising a catheter body defining a proximal end and a distal end, a wounding element including a RF electrode array extending distally from the distal end of the catheter body and movable relative to the catheter body between an extended position and a retracted position and including, and at least one plug housed within the wounding segment and defining pores selectively sized to encourage at least one of vascularized tissue ingrowth and vascularized capsule growth; inserting the catheter body and wounding element into the ovarian pathway; applying and operating the electrode array to cause a wound in the target segment of the pathway that necroses the epithelial layer; limiting the outward extent of the wound to the circular muscle layer by limiting the heating of the target segment by applying power of 0.1 to 5 watts to the RF electrode array for a period of at least about 5 seconds; maintaining both the catheter body and at the least one plug stationary relative to the target segment while simultaneously (i) moving the wounding segment relative to the catheter body from the extended position toward the retracted position and (ii) exposing and implanting said stationary plug within the wounded target segment of the pathway; and allowing the wounded target segment of the pathway to heal with the plug installed. - View Dependent Claims (18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
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31. A method of occluding the ovarian pathway of a female body, the ovarian pathway being characterized by an epithelial layer lining the inside of the ovarian pathway, a lamina propria layer surrounding the epithelial layer, a circular muscle layer surrounding the lamina propria layer and a longitudinal muscle layer surrounding the circular muscle layer, said method comprising the steps of:
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providing a device comprising a catheter body defining a proximal end and a distal end, a heating element extending distally from the distal end of the catheter body and movable relative to the catheter body between an extended position and a retracted position and including, and at least one plug housed within the heating element, wherein the at least one plug is sized and dimensioned to be implanted into a target segment within the ovarian pathway and defines pores selectively sized to encourage at least one of vascularized tissue ingrowth and vascularized capsule growth; inserting the catheter body and heating element into the ovarian pathway; applying the heating element to a target segment of the pathway, and operating the heating element to heat the target segment in the pathway; limiting the heating of the target segment to avoid wounding the longitudinal layer by limiting the heating of the target segment by applying power of 0.1 to 5 watts to the heating element for a period of at least about 5 seconds; and maintaining both the catheter body and at the least one plug stationary relative to the target segment while simultaneously (i) moving the heating element relative to the catheter body from the extended position toward the retracted position and (ii) exposing and implanting said stationary plug within the target segment of the pathway. - View Dependent Claims (32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44)
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Specification