Roy W. Martin

Real-time visualization of high-intensity focused ultrasound treatment using ultrasound imaging

High-intensity focused ultrasound (HIFU) and conventional B-mode ultrasound (US) imaging were synchronized to develop a system for real-time visualization of HIFU treatment. The system was tested in vivo in pig liver. The HIFU application resulted in the appearance of a hyperechoic spot at the focus that faded gradually after cessation of HIFU exposure. The duration of HIFU exposure needed for a hyperechoic spot to appear, was inversely related to the HIFU intensity. The threshold intensity required to produce a hyperechoic spot in liver in < 1 s was 970 W/cm(2), in situ. At this HIFU dose, no immediate cellular damage was observed, providing a potential for pretreatment targeting. The real-time visualization method was used in hemostasis of actively bleeding internal pelvic vessels, allowing targeting and monitoring of successful treatment. Real-time US imaging may provide a useful tool for image-guided HIFU therapy.

Ultrasound therapy head configured to couple to an ultrasound imaging probe to facilitate contemporaneous imaging using low intensity ultrasound and treatment using high intensity focused ultrasound

Method and apparatus for the simultaneous use of ultrasound on a probe for imaging and therapeutic purposes. The probe limits the effects of undesirable interference noise in a display by synchronizing high intensity focused ultrasound (HIFU) waves with an imaging transducer to cause the noise to be displayed in an area of the image that does not overlap the treatment site. In one embodiment, the HIFU is first energized at a low power level that does not cause tissue damage, so that the focal point of the HIFU can be identified by a change in the echogenicity of the tissue caused by the HIFU. Once the focal point is properly targeted on a desired treatment site, the power level is increased to a therapeutic level. The location of each treatment site is stored and displayed to the user to enable a plurality of spaced-apart treatment sites to be achieved. As the treatment progresses, any changes in the treatment site can be seen in the real time, noise-free image. A preferred application of the HIFU waves is to cause lesions in blood vessels, so that the supply of nutrients and oxygen to a region, such as a tumor, is interrupted. The tumor will thus eventually be destroyed. In a preferred embodiment, the HIFU is used to treat disorders of the female reproductive system, such as uterine fibroids. The HIFU treatment can be repeated at spaced-apart intervals, until any remaining fibroid tissue is destroyed.

Three-dimensional echocardiographic assessment of annular shape changes in the normal and regurgitant mitral valve

OBJECTIVES To compare mitral annular shape and motion throughout the cardiac cycle in patients with normal hearts versus those with functional mitral regurgitation (FMR). BACKGROUND The causes of mitral regurgitation without valvular disease are unclear, but the condition is associated with changes in annular shape and dynamics. Three-dimensional (3D) imaging provides a more comprehensive view of annular structure and allows accurate reconstructions at high spatial and temporal resolution. METHODS Nine normal subjects and 8 patients with FMR undergoing surgery underwent rotationally scanned transesophageal echocardiography. At every video frame of 1 sinus beat, the mitral annulus was manually traced and reconstructed in 3D by Fourier series. Annular projected area, nonplanarity, eccentricity, perimeter length, and interpeak and intervalley spans were determined at 10 time points in systole and 10 points in diastole. RESULTS The mitral annulus in patients with FMR had a larger area, perimeter, and interpeak span than in normal subjects (P <.001 for all). At mid-systole in normal annuli, area and perimeter reach a minimum, nonplanarity is greatest, and projected shape is least circular. These cyclic variations were not significant in patients with FMR. Annular area change closely paralleled perimeter change in all patients (mean r = 0.96 +/- 0.07). CONCLUSIONS FMR is associated with annular dilation and reduced cyclic variation in annular shape and area. Normal mitral valve function may depend on normal annular 3D shape and dimensions as well as annular plasticity. These observations may have implications for design and selection of mitral annular prostheses.

Hemostasis of punctured blood vessels using high-intensity focused ultrasound

The hemorrhagic complications of vascular injury can be significant. We report on the use of high-intensity focused ultrasound (HIFU) to stop the hemorrhage of punctured blood vessels in pigs. Two HIFU transducers with frequencies of 3.5 and 2.0 MHz, each equipped with a water-filled conical housing, were used. Major blood vessels (femoral artery and vein, axillary artery, carotid artery and jugular vein), 2-10 mm in diameter, of anesthetized pigs were exposed surgically and punctured with 14- and 18-gauge needles to produce moderate to profuse bleeding. Complete hemostasis was achieved in less than 3 min of HIFU treatment in most blood vessels, and all vessels were patent after the treatment. Both HIFU frequencies were effective in producing hemostasis. Gross examination of the HIFU-treated vessels showed a consistent hardening of the soft tissue surrounding the blood vessels, providing a seal for the puncture hole. Microscopic examination of the vessels showed a remarkably localized HIFU treatment, resulting in coagulation of the adventitia, and an extensive fibrin network around the vessels and in the puncture hole. The vessel walls exhibited focal swelling, without evidence of irreversible injury. HIFU may provide a useful method for achieving hemostasis of punctured and traumatized blood vessels in a variety of clinical settings.

Experimental evaluation of an endoscopic ultrasound probe: In vitro and in vivo canine studies

We developed an endoscopic echo probe that can be passed via the biopsy channel of a flexible fiberoptic or video endoscope with a 3.5-mm channel. The probe moves along the gastrointestinal wall under direct endoscopic vision. The translational scanning action is sensed by a position potentiometer and combines with the ultrasonic B-mode echoes to produce a cross-sectional image of the wall. The system uses an ultrasound frequency of 20 MHz to produce high-resolution images. The device was used to image canine gastrointestinal tissue in vitro and in vivo during endoscopy. Ultrasound images of the gut wall correlate with histologic structure. This probe overcomes some of the problems associated with the combined ultrasound endoscopes now in use. Use of the probe with video endoscopy allows the endoscopic and ultrasound images to be displayed side by side, simplifying coordination of application of the two techniques.

System for quantitative three-dimensional echocardiography of the left ventricle based on a magnetic-field position and orientation sensing system

Accurate measurement of left-ventricular (LV) volume and function are important to monitor disease progression and assess prognosis in patients with heart disease. Existing methods of three-dimensional (3-D) imaging of the heart using ultrasound have shown the potential of this modality, but each suffers from inherent restrictions which limit its applicability to the full range of clinical situations. The authors have developed a technique for image acquisition using a magnetic-field system to track the 3-D echocardiographic imaging planes and 3-D image analysis software including the piecewise smooth subdivision method for surface reconstruction. The technique offers several advantages over existing methods of 3-D echocardiography. The results of validation using in vitro LVs show that the technique allows accurate measurement of LV volume and anatomically accurate 3-D reconstruction of LV shape and is, therefore, suitable for analysis of regional as well as global function.

Performance of a miniature magnetic position sensor for three-dimensional ultrasound imaging

A miniature magnetic position sensor used for three-dimensional ultrasound imaging was tested for precision and accuracy in vitro. The sensor alone was able to locate points with root-mean-square (rms) uncertainty of 1.7 mm and accuracy of 0.05 +/- 0.62 mm over its specified operating range of 50 cm. With an ultrasound imaging system, a point was located from arbitrary viewing windows with 2.4-mm rms uncertainty and 0.06 +/- 0.68 mm accuracy. If viewing windows were limited to those representative of a typical ultrasound examination, the system could achieve rms uncertainty in point location of < 1 mm. Performance was not affected by operation of the imaging system when the sensor was mounted on an ultrasound scanhead. Sensitivity to metals in the operating environment was also measured.

Use of high-intensity focused ultrasound to control bleeding

OBJECTIVE High-intensity focused ultrasound (HIFU) has been shown to be effective in controlling hemorrhage from punctures in blood vessels. The objective of the current study was to investigate the capability of HIFU to stop bleeding after a more severe type of vascular injury, namely longitudinal incisions of arteries and veins. METHODS The superficial femoral arteries, common femoral arteries, carotid arteries, and jugular veins of four anesthetized pigs were exposed surgically. A longitudinal incision, 2 to 8 mm in length, was produced in the vessel. HIFU treatment was applied within 5 seconds of the onset of the bleeding. The HIFU probe consisted of a high-power, 3.5-MHz, piezoelectric transducer with an ellipsoidal focal spot that was 1 mm in cross section and 9 mm in axial dimension. The entire incision area was scanned with the HIFU beam at a rate of 15 to 25 times/second and a linear displacement of 5 to 10 mm. A total of 76 incisions and HIFU treatments were performed. RESULTS Control of bleeding (major hemosatsis) was achieved in all 76 treatments, with complete hemostasis achieved in 69 treatments (91%). The average treatment times of major and complete hemostasis were 17 and 25 seconds, respectively. After the treatment, 74% of the vessels in which complete hemostasis was achieved were patent with distal blood flow and 26% were occluded. The HIFU-treated vessels showed a consistent coagulation of the adventitia surrounding the vessels, with a remarkably localized injury to the vessel wall. Extensive fibrin deposition at the treatment site was observed. CONCLUSION HIFU may provide a useful method of achieving hemostasis for arteries and veins in a variety of clinical applications.

An image‐guided high intensity focused ultrasound device for uterine fibroids treatment

A high intensity focused ultrasound (HIFU) device was developed for treating uterine fibroid tumors. This prototype device enables image-guided therapy by aligning a commercially available abdominal ultrasound image probe to a vaginal HIFU transducer so the HIFU focus is in the image plane. The device was designed based on anatomical constraints of the female pelvic structures. HIFU was generated using a 3.5 MHz PZT-8 crystal, 25.4 mm in diameter, bonded to an aluminum lens. Computer simulations were performed to ensure that effective focusing was achievable at a fixed focal depth of 40 mm. Transducer efficiency was empirically determined to be 58%, and the half pressure maximum focal dimensions were 11 mm in length and 1.2 mm in width. A water-filled latex condom surrounding the transducer provided acoustic coupling, a stand-off, and allowed water circulation for transducer cooling. In vitro experiments in a tissue-mimicking gel phantom and in turkey breast demonstrated ultrasound image-guided lesion formation, or tissue necrosis, at the focus due to HIFU induced thermal and cavitation effects. The HIFU treatment site appeared as a hyperechoic spot on the ultrasound image at intensities above 1250 W/cm2. The results of in vitro experiments and in vivo ergonomic testing in six human volunteers indicated that the device has the potential of providing a nonsurgical approach for uterine fibroid treatment. Future in vivo studies in large animal models and fibroids patients are planned.

Hemostasis using high intensity focused ultrasound

High intensity focused ultrasound (HIFU) has been shown to be an effective method of hemostasis, in animal studies, for both solid organs and blood vessels. Two distinct effects of HIFU, thermal and mechanical, appear to contribute to hemostasis. Acoustic hemostasis may provide an effective method in surgery and prehospital settings for treating trauma and elective surgery patients. A review of the methodology is given.