Echogenic needle for transvaginal ultrasound directed reduction of uterine fibroids and an associated method

Abstract

The invention is a transvaginal ultrasound probe having an attached echogenic needle that is useful in the treatment of uterine fibroids. The echogenic needle has an echogenic surface near its tip that allows the physician to visualize its location using ultrasound imaging. In one embodiment, the needle has an active electrode at its distal end. The active electrode supplies radio frequency energy to a fibroids causing necrosis of the targeted fibroid or by destroying the fibroid's vascular supply. The radio frequency needle preferably has a safety device that shuts-off energy if the needle punctures the uterine wall. In a second embodiment, the needle has a cryogen supply tube and cryogen supply. This embodiment destroys fibroid tissue by freezing it or its vascular supply when the tissue comes in contact with the needle's frozen distal end. The invention further includes the method of using the ultrasound probe with the attached needle.

Description

CROSS REFERENCE TO RELATED APPLICATION [0001] This application is a divisional application of U.S. application Ser. No. 10 / 345,635, filed Jan. 16, 2003, which is hereby incorporated herein in its entirety by reference.BACKGROUND OF THE INVENTION [0002] This invention relates to surgical needles for tissue ablation, and more particularly, to surgical needles that are for ablation of uterine fibroids. [0003] Approximately 20 to 40 percent of women have uterine fibroids (lieomyomata). In the United States, fibroids result in approximately 175,000 hysterectomies and 20,000 myomectomies each year. Fibroids are well-defined, non-cancerous tumors that arise from the smooth muscle layer of the uterus. Approximately 25% of women suffer fibroid related symptoms, including menorrhagia (prolonged or heavy menstrual bleeding), pelvic pressure or pain, and reproductive dysfunction. [0004] The most common treatments for fibroids include hysterectomy, abdominal myomectomy, laparoscopic myomectomy, ...

AI Technical Summary

Benefits of technology

"The invention is a medical needle designed for transvaginal ultrasound directed reduction of fibroids. The needle has an echogenic tip and is used in conjunction with a transvaginal ultrasound probe. The needle can be guided and positioned on the surface of a fibroid using ultrasound imaging, and a controlled amount of RF energy or cryogenic supply can be delivered to the fibroid through the needle. The technical effects of the invention include improved visibility of the needle on ultrasound images, improved guidance and positioning of the needle, and reduced risk of injury during the procedure."

Problems solved by technology

Hysterectomy is a major surgical procedure and carries with it the usual risk of surgery, such as hemorrhaging, lesions, complications, pain, and prolonged recovery.

Abdominal myomectomy and laparoscopic myomectomy, like a hysterectomy, carries the usual risk of surgery.

Direct visualization is often problematic because of the difficulties involved in simultaneously manipulating the endoscope and needle.

Similar to an endoscope, a hysteroscope must be simultaneously manipulated with the needle, and thus is problematic.

For example, a clinician using ultrasound imaging from an external source will have difficulty in distinguishing the uterine tissue from the surrounding organs and precisely locating the needle.

As a result, uterine adhesions often form that may cause chronic pain, infertility, and bowel obstruction.

Additionally, during laparoscopic surgery the surgeon cannot visualize the tissue below the surface and must blindly place the needle, as a result placement may be sub-optimal.

There is the risk that the needle guide could shift during removal of the endoscope and insertion of the ablation device, resulting in sub-optimal performance.

Reinserting and removing the endoscope and ablation device every time the needle must be repositioned increases the time and expense of the surgery.

The cryo / electro needle is not easily visualized when in use and requires the use of a dilator to create an access channel in the tissue area where the needle is to be inserted.

Similar to laparscopic surgery, placement of the cryo / electro needle is done blindly and may not result in optimal performance.

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