Systems and methods for endometrial ablation
View Patent ↗A system for treating uterine tissue comprises an elongated introducer with a working end configured for endometrial ablation. The working end includes an expandable seal for positioning in a patient's cervical canal and an actuator pump mechanism carried by a proximal handle coupled to the introducer for expanding the seal. The handle optionally includes a mechanism for simultaneously expanding the seal and deploying a treatment element on the working end of the introducer.
1. A system for treating uterine tissue comprising:
an elongated introducer having a distal working end configured for transcervical introduction to a uterus and a proximal handle;
a treatment element disposed on the working end of the elongated introducer;
an inflatable seal proximal of the treatment element on the elongated introducer for positioning in a patient's cervical canal;
an actuator pump mechanism comprising a positive displacement device carried by the proximal handle coupled to the introducer for inflating the seal, wherein the handle comprises a lever structure which compresses the positive displacement device when the lever structure is closed; and
a frame coupled to the lever structure configured to deploy the treatment element simultaneously with inflating the seal.
2. A system as in claim 1 , wherein the treatment element comprises an expandable bladder.
3. A system as in claim 2 , wherein the lever structure is configured to deploy the frame which expands the bladder.
4. A system as in claim 3 , wherein the lever structure is configured to also inflate the bladder.
5. A system as in claim 1 , wherein the inflatable seal comprises a deformable thin-walled sleeve disposed over a distal length of the introducer and configured for engaging a cervical canal when inflated.
6. A system as in claim 5 , wherein the seal comprises an elastomeric material.
7. A system as in claim 6 , wherein the seal comprises a thin wall silicone.
8. A system as in claim 5 , wherein the seal is formed with helical ridge and valley regions.
9. A system as in claim 1 , further comprising a pressure relief valve between the actuator pump and the inflatable seal which is configured to prevent over-inflation of the seal when the lever structure is fully closed.
10. A method for treating a uterus, said method comprising:
providing a treatment tool comprising an elongate introducer having a handle at a proximal end thereof, a treatment element at a distal end thereof, and a cervical seal proximal to the treatment element;
advancing the introducer through a cervical canal into the uterus so that the cervical seal is positioned in the cervical canal;
actuating a lever on the handle to simultaneously inflate the seal within the cervical canal and to conform the treatment element to the uterus; and
treating the uterus with the treatment element while the treatment element remains conformed to the uterus and the seal remains inflated within the cervical canal.
11. A method as in claim 10 , wherein the treatment element comprises a deployable bladder, wherein actuating the lever deploys a frame within the bladder to expand the bladder within the uterus.
12. A method as in claim 11 , wherein actuating the lever also actuates the pump to inflate the bladder to further expand the bladder within the uterus.
13. A method as in claim 10 , wherein treating the uterus comprises igniting a plasma within the bladder.
14. A method as in claim 10 , further comprising limiting an inflation pressure of the seal when the lever is actuated.
15. A method as in claim 14 , wherein limiting the inflation pressure comprises placement of a pressure relief valve in an inflation line disposed between a pump coupled to the lever and the seal.