Device for instillation of a chemical agent into the endometrial cavity for purpose of global endometrial ablation
A device for chemical endometrial ablation comprising an outer tube, a moveable cervical collar surrounding a portion of the outer tube and located near the distal end of the outer tube, an inner tube movable in a distal-proximal direction within the lumen of the outer tube, a porous and/or sponge-like material on the distal end of the inner tube within the lumen of the distal end of the outer tube having a size, shape, and expandability so that when the distal end of the inner tube within the distal end of the outer tube is moved in a distal direction in relation to the outer tube, the porous and/or sponge-like material expands to the approximate size of a uterus so as to contact the endometrium, a source of cauterizing agent, and means to cause the cauterizing agent to flow through the lumen of the inner tube onto the porous and/or sponge-like material. In operation, the cervical collar can be moved or advanced along the outer tube to the cervix and secured tightly around the external portio in order to prevent chemical cauterizing agent from entering the vagina.
1. A device for chemical endometrial ablation comprising:
an outer tube having a lumen, a proximal end, a distal end, and an inner diameter;
a cervical collar surrounding a portion of the outer tube on the outer tube and moveable in a distal-proximal direction along the outer tube, the collar configured to fit around the external portio of a cervix;
an inner tube having a lumen, a proximal end, a distal end, and an outer diameter less than the inner diameter of the outer tube, the inner tube movable in a distal-proximal direction within the lumen of the outer tube;
a sponge comprising a porous material on the distal end of the inner tube and compressed within the lumen of the distal end of the outer tube, the sponge having a size, shape, and expandability configured to match the approximate size and shape of a uterine cavity and conform to the contours of the endometrial surface of the uterus when the distal end of the inner tube is moved in a distal direction to exit the lumen of the outer tube; and
a delivery system containing a cauterizing agent secured to an opening at the proximal end of the inner tube, the delivery system configured to deliver the cauterizing agent through the lumen of the inner tube and through the pores of the sponge.
2. The device of claim 1 wherein the cauterizing agent is trichloroacetic acid or its derivatives or silver nitrate or its derivatives.
3. The device of claim 1 wherein the delivery system comprises a syringe fluidly connected to the proximal end of the inner tube.
4. The device of claim 1 wherein the outer tube has markings to allow an operator to gauge depth of insertion into the uterine cavity.
5. The device of claim 1 wherein the cervical collar is lined with an absorptive fiber.
6. The device of claim 1 wherein the cervical collar comprises means to secure the collar to the portio of the cervix to prevent the chemical cauterizing agent from exiting the uterus and entering the vagina.
7. The device of claim 6 wherein the means to secure the collar comprises a drawstring.
8. The device of claim 1 wherein the cauterizing agent is trichloroacetic acid.
9. A method for chemical endometrial ablation comprising: providing a device according to claim 1 , moving the distal end of the inner tube in a distal direction in relation to the outer tube, causing the sponge to exit the lumen of the outer tube and expand to contact the endometrial surface of the uterus; causing the cauterizing agent to flow through the lumen of the inner tube and through the pores of the sponge onto the endometrial surface; and moving the distal end of the inner tube in a proximal direction in relation to the outer tube, retracting the sponge back into the distal end of the outer tube.
10. The device of claim 1 wherein the delivery system is configured to prevent the cauterizing agent from exiting the delivery system before the sponge is expanded in the uterine cavity.