Devices and methods for treatment of tissue

Abstract

Delivery systems, and methods using the same, having an ultrasound viewing window for improved imaging and a needle for ablation treatment of target tissues. In an embodiment, the target tissue is a fibroid within a female's uterus. In an embodiment, the delivery system includes a rigid shaft having a proximal end, a distal end, and an axial passage extending through the rigid shaft. In an embodiment, the axial passage is configured for removably receiving the ultrasound imaging insert having an ultrasound array disposed a distal portion.

Description

CROSS-REFERENCE TO RELATED APPLICATION[0001]This application is a continuation of U.S. application Ser. No. 13 / 667,891 (Attorney Docket No. 31992-706.502), filed Nov. 2, 2012, which is a continuation-in-part of U.S. application Ser. No. 12 / 973,587 (Attorney Docket No. 31992-706.301), filed Dec. 20, 2010, which is a continuation of U.S. application Ser. No. 11 / 564,164 (Attorney Docket No. 31992-706.501), filed on Nov. 28, 2006, which is a continuation-in-part of U.S. application Ser. No. 11 / 409,496 (Attorney Docket No. 31992-706.201), filed on Apr. 20, 2006, the full disclosures of which are incorporated herein by reference; U.S. application Ser. No. 13 / 667,891 (Attorney Docket No. 31992-706.502), filed Nov. 2, 2012, is also a continuation-in-part of U.S. application Ser. No. 11 / 620,594 (Attorney Docket No. 31992-704.201), filed on Jan. 5, 2007, which claimed the benefit of Provisional Application 60 / 758,881 (Attorney Docket No. 31992-704.101), filed on Jan. 12, 2006, the full disclo...

AI Technical Summary

Benefits of technology

[0017]In an embodiment, the rigid delivery shaft preferably has a deflectable or fixed pre-shaped or pre-angled distal end. The delivery shaft distal end may be deflected or bent at an angle in a range from about 0 degrees to about 80 degrees relative to the shaft axis, preferably in a range from about 10 degrees to about 25 degrees. The ultrasound imaging insert will usually be flexible (and in some instances deflectable or steerable) so that the distal portion of the ultrasound imaging insert is conformable or bendable to the same angle as the shaft deflectable distal end. The cumulative effect of array tilting and shaft bending advantageously provides an enhanced viewing angle of the ultrasound imaging insert, which is in a range from about 7 degrees (i.e., angle due to tilted ultrasound array) to about 90 degrees relative to the shaft axis.

[0019]In an embodiment, the interventional core preferably comprises a curved needle coupled to the rigid shaft via a needle guide. Significantly, an angle of needle curvature is dependent upon (e.g., inversely proportional to) the ultrasound array tilt and the shaft bend. For example, an increase in an angle of array tilting or shaft bending decreases an angle of needle curvature. This in turn provides several significant advantages such as allowing a treating physician or medical facility to selectively choose an appropriate needle curvature based upon such indications (e.g., variability in needle curvature). Further, a decrease in the angle of needle curvature provides for enhanced pushability, deployability, and / or penetrability characteristics as well as simplified manufacturing processes. The angle of needle curvature may be in a range from about 0 degrees to about 80 degrees relative to an axis, preferably the angle is about 70 degrees when the viewing angle is about 20 degrees. The curved needle generally comprises a two-piece construction comprising an elongate hollow body and a solid distal tip. The solid tip may comprise an asymmetric or offset trocar tip. For example, the tip may comprise a plurality of beveled edges offset at a variety of angles. It will be appreciated that the needle may take on a variety of geometries in accordance with the intended use.

[0021]In an embodiment, the curved needle and needle guide have a flattened oval shape that has a wideness that is greater than a thickness. This oval cross sectional shape is intended to inhibit lateral deflection during deployment or penetration of the needle. The needle is configured to deliver to the target site radio frequency energy (or other ablative energy such as, but not limited to, electromagnetic energy including microwave, resistive heating, cryogenic) generated at a relatively low power and for relatively a short duration of active treatment time.

Problems solved by technology

Fibroid tumors affect up to 30% of women of childbearing age and can cause significant symptoms such as discomfort, pelvic pain, mennorhagia, pressure, anemia, compression, infertility, and miscarriage.

All medications are relatively ineffective and are palliative rather than curative.

Often these surgical procedures are associated with the typical surgical risks and complications along with significant blood loss and can only remove a portion of the culprit tissue.

However, laparoscopic myomectomy remains technically challenging, requiring laparoscopic suturing, limiting its performance to only the most skilled of laparoscopic gynecologists.

While effective, hysterectomy has many undesirable side effects such as loss of fertility, open surgery, sexual dysfunction, and long recovery time.

There is also significant morbidity (sepsis, hemorrhage, peritonitis, bowel and bladder injury), mortality and cost associated with hysterectomy.

The procedure requires the filling of the uterus with fluid for better viewing, and thus has potential side effects of fluid overload.

Hysteroscopic ablation is limited by its visualization technique and thus, only appropriate for fibroids which are submucosal and / or protrude into the uterine cavity.

In addition, long term MM data suggests that incomplete fibroid infarction may result in regrowth of infarcted fibroid tissue and symptomatic recurrence.

Endometrial ablation destroys the endometrial tissue lining the uterus, and although an excellent choice for treatment of dysfunctional uterine bleeding, it does not specifically treat fibroids.

This technique is also not suitable treatment of women desiring future childbearing.

As with all laparoscopic techniques, myolysis treatment is limited by the fact that it can only allow for visualization of subserosal fibroids.

The aim of needle myolysis is to coagulate a significant volume of the tumor, thereby cause substantial shrinkage.

However, the desirability of multiple passes is diminished by the risk of adhesion formation which is thought to escalate with increasing amounts of injured uterine serosa, and by the operative time and skill required.

Myolysis is generally limited by its usage with direct visualization techniques, thus being limited to the treatment of subserosal fibroids.

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