Tissue treatment method and apparatus

#This invention relates to instruments for the conduct of minimally invasive medical procedures which may be conducted with the aid of laparoscopic techniques, and to such procedures themselves. It is disclosed in the context of high-intensity focused ultrasound ablation of kidney tissue, but is believed to be useful in other applications as well.

#Several minimally invasive and non-invasive techniques for the treatment of living tissues and organs with ultrasound, including high-intensity, focused ultrasound, sometimes referred to hereinafter as HIFU, are known. There are, for example, the techniques and apparatus described in U.S. Pat. Nos. 4,084,582; 4,207,901; 4,223,560; 4,227,417; 4,248,090; 4,257,271; 4,317,370; 4,325,381; 4,586,512; 4,620,546; 4,658,828; 4,664,121; 4,858,613; 4,951,653; 4,955,365; 5,036,855; 5,054,470; 5,080,102; 5,117,832; 5,149,319; 5,215,680; 5,219,401; 5,247,935; 5,295,484; 5,316,000; 5,391,197; 5,409,006; 5,443,069; 5,470,350; 5,492,126; 5,573,497; 5,601,526; 5,620,479; 5,630,837; 5,643,179; 5,676,692; 5,840,031. The disclosures of these references are hereby incorporated herein by reference. This listing is not intended to be a representation that a thorough search has been made of the relevant art, or that no better references than those listed are available. Nor should any such representation be inferred.

#According to an aspect of the invention, an apparatus and method employ first, second and third devices for introduction of equipment into, and removal of equipment from, a body region, an optical imaging system, a source of a relatively non-reactive fluid for expanding the body region to facilitate the introduction of components of the apparatus into the body region and manipulation of the introduced components of apparatus, and an ultrasound apparatus for at least one of visualization and treatment of the body region. A first of the devices facilitates passing of the component of the optical imaging system into and out of the body region. A second of the devices facilitates passing the fluid between the fluid source and the body region. A third of the devices facilitates passing the ultrasound visualization and/or treatment apparatus into and out of the body region.

#The invention may best be understood by referring to the following detailed description and accompanying drawings which illustrate the invention. In the drawings:

#FIG. 1 illustrates a partly block diagrammatic, partly fragmentary perspective view of a procedure according to the present invention;

#FIG. 2 illustrates an exploded, fragmentary perspective view of a device useful in the conduct of the procedure illustrated in FIG. 1;

#In an illustrated minimally invasive, HIFU-based procedure, the patient 20 is first prepared by the insertion of a guide wire 24 through the urethra 28 and bladder 32 into the ureter 36 of a diseased kidney 40. The guide wire 24 is, of course, radiopaque, so that its progress to the surgical field can be straightforwardly monitored. Then, using the guide wire 24, a urological catheter 44 is inserted along the same path to permit the introduction of fluid species into the surgical site 48. Next, three incisions 50, 52, 54 are made on the abdomen 56 below the diaphragm through trocars 60. The trocars 60 are left in place, as is customary, to permit the sealing of the abdomen 56 when instruments are passed through the seals 64 of the trocars 60 into the abdomen 56 for the conduct of the procedure.

#A laparoscope 68 for providing visual observation of the surgical field is passed through one of the trocars 60. The laparoscope 68 is conventionally coupled to a video camera 72 and a light source 76 for illuminating the surgical field and returning images to a surgical monitor 84. The laparoscope provides a pair of fiberoptic ports, one an output port for light from source 76 to the surgical field, and one an input port for the returning image information to video camera 72. A second of the trocars 60 provides, among other things, a passageway for the introduction into the abdomen 56 of a relatively inert gas, such as, for example, carbon dioxide, from a source 88 in order to permit the inflation of the abdomen 56 below the diaphragm. This increases the space inside the abdomen 56 for maneuvering surgical instruments including the laparoscope 68, and provides a clearer view of the surgical field.

#The third trocar 60 provides access through the abdominal wall and into the surgical field for a HIFU probe 90 which will be used to ablate the surgical site 48 of a diseased kidney 40, for example, for the virtually bloodless ablation of (a) tumor(s) on the surface of, and/or within, the kidney 40. Should the surgical procedure call for it, additional trocars 60 can, of course, be provided for passing into the body additional HIFU probes 90 to be used in conjunction with each other in an ablation procedure. The presence of the catheter 44 in the kidney 40 also permits the introduction into the surgical field of (an) ablation enhancing medium (media) and other media at (an) appropriate time(s) during the procedure. The same, or a different, medium (media) may also be introduced through the catheter 44 to improve the accuracy of the targeting of the surgical site 48 for ablation and provide feedback to the treating physician of the progress of the treatment. For example, lesions which are not on the surface of the tissue 40 being treated are not easily visible, or in many cases visible at all, in the laparoscopically informed monitor 84.