METHODS AND SYSTEMS FOR CONTROLLED THERMAL TISSUE
A body passage having an interior wall with a lining is occluded by introducing a thermal delivery catheter to the passage. The thermal delivery catheter has a thermal transfer region which can deliver both a coagulative tissue necrosis energy dosage and a thermally fixing energy dosage. The coagulative necrosis dosage will result in scar tissue formation, while the thermally fixing tissue dosage will prevent regrowth of the tissue lining from neighboring untreated tissue regions which could compromise the integrity of the occlusion which is formed.
1 . A method for occluding a body passage having an interior wall with a lining, said method comprising:
inducing coagulative tissue necrosis at a location in said passage; and
thermally fixing a peripheral zone of tissue over at least a portion of an interior wall surrounding or adjacent to the coagulative tissue necrosis;
wherein the coagulative tissue necrosis occludes said passage and the thermally fixed contiguous ring inhibits regrowth of the tissue lining along the interior wall.
2 . A method as in claim 1 , wherein inducing coagulative tissue necrosis and thermally fixing a contiguous zone of tissue comprise engaging an energy transfer device against the interior wall of the passage proximate the location and delivering both a coagulative energy dosage and a thermally fixing energy dosage from the energy transfer device.
3 . A method as in claim 2 , wherein the energy transfer device comprises a plurality of axially spaced-apart ring electrode structures which are selectively energized at different times to provide the coagulative energy dosage and the thermally fixing energy dosage.
4 . A method as in claim 2 , wherein the energy transfer device comprises different energy transfer regions adapted to deliver the coagulative energy dosage and the thermally fixing energy dosage simultaneously.
5 . A method as in claim 2 , wherein the body passage is at the cornu of a uterus and the lining comprises an endometrium, further comprising conforming the energy transfer device to the shape of the cornu prior to delivering the energy dosages.
6 . A method as in claim 2 , wherein the body passage is a Fallopian tube and the lining comprises an endothelium, further comprising advancing the energy transfer device into an interstitial region of the Fallopian tube prior to delivering the energy dosages.
7 . A method as in claim 6 , further comprising removing the energy transfer device after the energy dosages have been delivered and delivering an implant.
8 . A method as in claim 6 , further comprising leaving the energy transfer device as a permanent implant within the interstitial region.
9 . A method as in claim 1 , wherein inducing coagulative tissue necrosis comprises delivering radiofrequency energy at a power of 5 to 10 Watts and energy density in the range from 50 J/cm 2 to 150 J/cm 2 thermally fixing the contiguous stripe of tissue comprises delivering radiofrequency energy at a power of 15 to 30 Watts and energy density in the range from 100 J/cm 2 to 200 J/cm 2 .
10 . A method as in claim 9 , wherein the passage is the cornu of a uterus and the coagulative tissue necrosis is induced over a length of endometrium in the range from 5 mm to 15 mm and the thermally fixed stripe has a width in the range from 1 mm to 5 mm.
11 . A method as in claim 9 , wherein the passage is an interstitial region of a Fallopian tube and the coagulative tissue necrosis is induced over a length of endothelium in the range from 2 mm to 10 mm and the thermally fixed stripe has a width in the range from 1 mm to 5 mm.
12 . A system for delivering energy to occlude a body passage, said system comprising:
a catheter adapted to be transcervically introduced to a uterus;
an energy transfer surface at a distal end of the catheter; and
a power supply connectable to the catheter and programmable to deliver both a thermally fixing energy dosage to the energy transfer surface and a coagulative necrosis energy dosage to the energy transfer surface.
13 . A system as in claim 12 , wherein the energy transfer surface comprises a plurality of axially spaced-apart ring electrode structures and the power supply comprises switching circuitry which may be selectively configured to deliver bipolar radiofrequency energy to pairs of said ring electrode structures to provide both the thermally fixing energy dosage and the coagulative necrosis energy dosage.
14 . A system as in claim 13 , wherein the switching circuitry is at least partially implemented by software.
15 . A system as in claim 12 , wherein the energy transfer surface comprises an electrode array and an electrically resistive cover over a portion thereof wherein the power supply delivers radiofrequency energy to the electrode array and the electrically resistive cover creates a low energy transfer region which delivers the coagulative necrosis energy dosage and a high energy transfer region which delivers the thermally fixing energy dosage.
16 . An energy delivery catheter comprising:
a catheter body having a proximal end, a distal end, and adapted to be transcervically introduced into the uterus;
an electrode support structure on the distal end of the catheter body and having a surface which can be expanded to conform to a cornu in the uterus.;
an electrode array on the surface of the support structure, wherein said array comprises at least four axially spaced-apart ring electrode structures which are expandable to engage endometrial tissue of the cornu when the support structure is expanded, and
at least four electrically isolated electrical conductors with at least one such conductor connected to each of the at least four ring electrode structures.
17 . A catheter as in claim 16 , wherein the catheter body is curved so that it will conform to a side of the uterus from the cervical os to the cornu.
18 . A catheter as in claim 17 , wherein the electrode support expands radially outwardly relative to the curve of the catheter body.
19 . A catheter as in claim 18 , wherein the electrode support expands to a triangular profile with a peak directed radially outwardly.
20 . A catheter as in claim 16 , wherein the electrode support structure is mechanically expansible.
21 . An energy delivery catheter comprising:
a catheter body having a proximal end, a distal end, and adapted to be transcervically introduced into the uterus; and
an electrode structure at the distal end of the catheter body, said electrode structure including an electrode array and an electrically resistive cover over a portion of the electrode array to create a low energy transfer region to deliver a coagulative tissue necrosis dosage and an axially offset high energy transfer region to deliver a thermally fixing energy dosage.
22 . A catheter as in claim 21 , wherein the catheter body is curved so that it will conform to a side of the uterus from the cervical os to the cornu.
23 . A catheter as in claim 21 , wherein the electrically resistive cover comprises a composite of nylon and polyurethane.
24 . A catheter as in claim 21 , wherein the electrode array comprises at least two axially oriented bipolar electrode pairs.