Noise-free real time ultrasonic imaging of a treatment site undergoing high intensity focused ultrasound therapy
First Claim
1. A method for using ultrasound to simultaneously image a target area and to provide therapy to a treatment site disposed within said target area, producing a lesion in a blood vessel that occludes a blood supply relative to a region, comprising the steps of:
- (a) providing;
(i) a scanning ultrasonic transducer system adapted to scan a target area and to provide imaging data for said target area;
(ii) a processor adapted to process said imaging data;
(iii) a display capable of providing a visual representation of said imaging data to a user; and
(iv) a therapeutic ultrasonic transducer system adapted to provide waves of high intensity focused ultrasound (HIFU) to said treatment site;
(b) energizing said scanning ultrasonic transducer system to continually scan said target area to produce said imaging data;
(c) displaying a visual representation of said imaging data to the user on the display to produce a displayed target area;
(d) selecting the treatment site from within the displayed target area proximate a blood vessel supplying blood to the region; and
(e) directing the therapeutic waves of the HIFU at the treatment site with the therapeutic ultrasonic transducer system, said therapeutic ultrasonic transducer system being synchronized relative to the scanning ultrasonic transducer system such that any noise in said imaging data arising from said therapeutic waves is shifted away from the treatment site in the displayed target area, enabling the treatment site to be observed in real time as the therapeutic waves of the HIFU are administered to the treatment site, said therapeutic waves being of sufficient intensity to form a lesion in the blood vessel that occludes the blood vessel, preventing blood from continuing to flow into the region, so that oxygen and nutrients conveyed by blood flowing through the blood vessel do not reach the region.
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Accused Products
Abstract
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.
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Citations
63 Claims
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1. A method for using ultrasound to simultaneously image a target area and to provide therapy to a treatment site disposed within said target area, producing a lesion in a blood vessel that occludes a blood supply relative to a region, comprising the steps of:
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(a) providing;
(i) a scanning ultrasonic transducer system adapted to scan a target area and to provide imaging data for said target area;
(ii) a processor adapted to process said imaging data;
(iii) a display capable of providing a visual representation of said imaging data to a user; and
(iv) a therapeutic ultrasonic transducer system adapted to provide waves of high intensity focused ultrasound (HIFU) to said treatment site;
(b) energizing said scanning ultrasonic transducer system to continually scan said target area to produce said imaging data;
(c) displaying a visual representation of said imaging data to the user on the display to produce a displayed target area;
(d) selecting the treatment site from within the displayed target area proximate a blood vessel supplying blood to the region; and
(e) directing the therapeutic waves of the HIFU at the treatment site with the therapeutic ultrasonic transducer system, said therapeutic ultrasonic transducer system being synchronized relative to the scanning ultrasonic transducer system such that any noise in said imaging data arising from said therapeutic waves is shifted away from the treatment site in the displayed target area, enabling the treatment site to be observed in real time as the therapeutic waves of the HIFU are administered to the treatment site, said therapeutic waves being of sufficient intensity to form a lesion in the blood vessel that occludes the blood vessel, preventing blood from continuing to flow into the region, so that oxygen and nutrients conveyed by blood flowing through the blood vessel do not reach the region. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
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20. A method for using ultrasound to visualize and to provide therapy to a treatment site within a target area, such that an image is displayed to a clinician in real time, to continually provide feedback to the clinician relating to a focal point of therapeutic waves of high intensity focused ultrasound (HIFU) and a change in the treatment site, said method enabling a plurality of lesions to be produced in blood vessels supplying a region to occlude blood flow through the blood vessels into the region, comprising the steps of:
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(a) providing;
(i) a scanning ultrasonic transducer system adapted to scan the target area with a probe and to provide imaging data for said target area;
(ii) a processor adapted to process said imaging data;
(iii) a display that provides a visual representation of said imaging data to a clinician; and
(iv) a therapeutic ultrasonic transducer system adapted to provide the pulsed waves of the HIFU from the probe;
(b) positioning the probe of the scanning ultrasonic transducer system and energizing the scanning ultrasonic transducer system so that an image comprising a visual representation of the target area is continually generated on the display as a displayed target area;
(c) directing the therapeutic ultrasonic transducer system at a prospective treatment site that is within the displayed target area;
(d) initially energizing the therapeutic ultrasonic transducer system at a reduced energy level that is so as to produce a pulsed wave that is not energetic enough to produce a therapeutic effect at the treatment site, but is sufficiently energetic to produce a change in an echogenicity of tissue at the treatment site, a focal point of the therapeutic ultrasonic transducer system being visually apparent in the displayed target area visually represented on the display where the echogenicity of the tissue has thus been changed;
(e) moving the focal point of the therapeutic ultrasonic transducer system to a desired position on a blood vessel;
(f) increasing the energy level of the therapeutic ultrasonic transducer system to a therapeutic level to produce the therapeutic waves with sufficient energy to produce a lesion in the blood vessel at the focal point; and
(g) repeating steps (c) through (f) for treatment sites comprising each additional blood vessel from the plurality of blood vessels, until blood flow into the region is substantially terminated. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
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33. A method for treating a tumorous growth by damaging selected regions within the tumorous growth, comprising the steps of:
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(a) providing;
(i) a scanning ultrasonic transducer system adapted to scan a target area and to produce imaging data for said target area;
(ii) a processor adapted to process said imaging data;
(iii) a display that is adapted to present a visual representation of said imaging data; and
(iv) a high intensity ultrasonic transducer system that is adapted to produce high intensity focused ultrasound (HIFU) capable of damaging tissue within the tumorous growth;
(b) positioning and energizing the scanning ultrasonic transducer system to continually produce an image of the target area on the display comprising a displayed target area;
(c) selecting a treatment site within the tumorous growth that is visually represented in the displayed target area;
(d) focusing pulsed HIFU produced by the high intensity ultrasonic transducer system on the treatment site that was selected to damage tissue within the tumorous growth;
(e) focusing the high intensity ultrasonic transducer system onto a different selected region within the tumorous growth; and
(f) repeating steps (d) through (e) until a desired pattern of damaged areas in the tumorous growth has been achieved. - View Dependent Claims (34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44)
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45. A system for simultaneously using ultrasound for both imaging and therapeutic purposes, enabling a lesion to be produced in a blood vessel to occlude blood flow, comprising:
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(a) an ultrasonic scanning transducer disposed on a probe, said ultrasonic scanning transducer being adapted to generate an ultrasonic scanning wave and to receive the ultrasonic scanning wave after it is reflected from a target area in a patient'"'"'s body, producing a signal that is useful for deriving imaging data for the target area;
(b) a processor electrically coupled to the scanning ultrasonic transducer system capable to receive the signal, said processor processing the signal to produce the imaging data;
(c) a display electrically coupled to the processor, said display presenting a visual representation of the imaging data;
(d) a therapeutic ultrasonic transducer disposed on the probe and adapted to generate a pulsed high intensity focused ultrasonic (HIFU) therapeutic wave directed at a treatment site within the target area;
(e) a control circuit electrically coupled to the therapeutic ultrasonic transducer system that synchronizes generation of the pulsed HIFU therapeutic wave relative to the ultrasonic scanning wave produced by the scanning ultrasonic transducer system, such that any noise within the imaging data arising from the pulsed HIFU therapeutic wave is shifted within the visual representation of the imaging data appear outside the treatment site, said control circuit providing sufficient energy to the therapeutic ultrasound transducer to cause a lesion in a blood vessel that is included in the visual representation of the target area, so that blood flow through the blood vessel to a region is occluded by the lesion; and
(f) a power supply electrically coupled to supply an electrical current to energize the scanning ultrasonic transducer system, the therapeutic ultrasonic transducer system and the control circuit. - View Dependent Claims (46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60)
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61. A probe for administering ultrasound therapy from within a vaginal canal of a patient, said therapy being administered to a treatment site within the patient'"'"'s body and outside the vaginal canal, comprising:
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(a) an elongate supporting structure having a distal end and a proximal end, said elongate supporting structure including a section at its proximal end that is adapted to be grasped and manipulated by a clinician to at least initially position the elongate supporting structure at a desired location within the vaginal canal of the patient;
(b) an imaging transducer disposed at the distal end of the elongate supporting structure, said imaging transducer being adapted to emit ultrasound imaging pulses when excited by an imaging signal for use in producing an image of a target area in the patient'"'"'s body;
(c) a high intensity focused ultrasound (HIFU) transducer disposed at the distal end of the elongate supporting structure, proximate to the imaging transducer and sized and shaped to fit within the vaginal canal, said HIFU transducer having an aperture through which HIFU waves are transmitted, said aperture being of a sufficient size to produce therapeutic HIFU waves, so that the therapeutic HIFU waves have sufficient intensity remaining upon reaching the treatment site after being attenuated by their passage through up to 6 cm of intervening tissue, to achieve a desired therapeutic effect, while said therapeutic HIFU waves do not have so much intensity when emitted by the HIFU transducer as to damage adjacent tissue through which the therapeutic HIFU waves initially propagate toward the treatment site; and
(d) means for directing the therapeutic HIFU waves at the treatment site within the target area, said HIFU transducer being energized to render the HIFU therapy while the imaging transducer is energized to provide a signal for imaging the target area. - View Dependent Claims (62, 63)
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Specification