• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:

    公开号:SE536526C2
    申请号:SE1050075
    申请日:2008-06-24
    公开日:2014-02-04
    发明作者:Yolande Appelman；Pieter A Doevendans；Donald J Knight
    申请人:Internat Cardio Corp；
    IPC主号:
    专利说明:

    536 526 not suitable for all patients. Therefore, there is a need for a less invasive method for reducing or eliminating plaque formation in the arteries. Non-invasive methods for treating unwanted materials in tissues and vessels, typically in the cardiovascular system, have been proposed, for example, in U.S. Patents 5,657,760, US 5,590,657 and US 5,524,620. .
    However, these methods are not suitable for plaque reduction, let alone in the vascular system.
    Thus, there is a need for an accurate and reliable system for the removal and reduction of vascular plaque with a planned and controlled treatment therapy.
    SUMMARY OF THE INVENTION The present invention relates to a system for non-invasive raising of the temperature of tissue using ultrasonic energy waves, comprising: at least one ultrasonic emitting device arranged to emit ultrasonic energy waves to a focal point of target tissue, a temperature monitoring device of the target monitoring device for operating and controlling the ultrasonic emitting device for transmitting ultrasonic energy waves at a focal point of less than about 15 mms and having an intensity focus for said ultrasonic energy waves in the range from about soo w / crnz to aooo W / crnz, for raising the temperature of target tissue a desired temperature.
    The system comprises in one embodiment an imaging device arranged to provide an image of at least a portion of a mammalian body.
    In one embodiment, the imaging device is a magnetic resonance imaging device.
    The system comprises in one embodiment an image recognition unit arranged for determining the position of at least one vascular plaque in said image and for determining a position for the base of said vascular plaque, said device further determining one or more target positions at the base of the plaque.
    In one embodiment, said ultrasonic emitting device is a multifocus converter.
    In one embodiment, the ultrasonic emitting device is made of non-ferrous material and it is located in said magnetic resonance imaging device.
    In one embodiment, the ultrasonic emitting device is arranged for movement in angular direction and / or linearly.
    In one embodiment, the system includes a monitoring device for monitoring the relative position of target tissue with respect to heart rhythm.
    In one embodiment, the control unit is arranged to receive, by manual intervention and / or from an automatic control unit, a therapeutic treatment plan regarding the parameters for emitting energy waves.
    In one embodiment, the control unit is arranged for controlling said ultrasonic emitting device for transmitting intermittently pulsed ultrasonic energy waves.
    In one embodiment, the controller includes a timing device for determining the start and stop of each pulse relative to the heart rhythm.
    In one embodiment, the ultrasonic transmitting device is a high frequency ultrasonic device with energy waves in the range between about 0.8 MHz and about 4 MHz.
    The invention also relates to a control unit for an ultrasonic emitting device which emits an ultrasonic beam to a focal point of a target object, wherein the focal point of the energy waves is less than about 15 mm 3 and wherein the control unit is arranged to control said ultrasonic emitting device for emitting 500 cmz and about 3000 W / cmz to said focal point for raising the temperature in the target position to a desired temperature, and which control unit further comprises a data processing device for determining the target temperature in the focal point based on image data received from a temperature monitoring device. The invention also relates to a method for preparing a plan for non-invasive raising of the temperature of tissue in a vessel wall, which leads to a regression of vascular plaques, comprising the following steps: imaging at least a portion of a body determining an image, determining the position of at least one vascular plaque in said image, determining the position of the base of said vascular plaque and one or more target positions at the base of the plaque, determining the parameters for emitting ultrasonic energy waves from a source to a focal point which is less than about 15 mms and with an intensity focus for said ultrasonic energy waves in the range between about 500 W / cm 2 to about 3000 W / cm 2 for raising the temperature of target tissue in the vessel wall to a desired temperature sufficient to reduce or destroy vaso vasorum. In one embodiment of the method, the frequency of the ultrasonic energy waves is between about 0.8 MHz and about 4 MHz.
    Brief Description of the Drawings The invention is described in the following with reference to the accompanying drawings, in which: Figure 1 illustrates the system for non-invasive reduction of vascular plaque, and Figure 2 illustrates the treatment procedure for non-invasive reduction of vascular plaque. Detailed Description Figure 1 illustrates the system for non-invasive reduction of vascular plaque. Treatment is delivered to the patient 10 by means of an ultrasound emitting device, typically through a high frequency ultrasound, HFU, emitting device 20. During emission of treatment, the patient 10 is monitored by both an ECG monitoring device 30 and a magnetic resonance imaging (MRI) device 40. Output from the ECG monitoring device 30 and the MRI device 40 is sent to an interpreting processor device 50 which includes an image recognition device 60 and an image display device 70.
    The control device provides output data to the HFU control unit 80 which controls the transmission of energy by operating and controlling the HFU device 20.
    During the procedure, the patient 10 is placed in a comfortable position on a treatment table where the patient must remain still. Because the procedure is non-invasive, it can be performed without any anesthesia and without causing discomfort to the patient. The treatment table is located inside the MRI device 40 so that the MRI images can be taken during the procedure for positioning target lesions and for monitoring the progress of the treatment. The MRI device 40 must be able to provide sharply detailed images of the arteries so that the base of the plaque can be accurately identified on the back of the plaque at the vessel wall. An MRI device 40 that provides images that can visualize tissue with a nanometer-level resolution, such as 1.5 Tesla MRI unit, 3 Tesla MRI unit, or 7 Tesla MRI unit, can be used in embodiments of the invention to provide these accurate pictures.
    The patient 10 is also monitored by an ECG monitor 30 for the duration of the procedure. The ECG monitoring unit 30 may be a standard 12-lead ECG or may be of a smaller lead design. Like all other components used in or near the MR1 device 40, the ECG monitoring device 30 must not include any ferrous material. The beats of the patient's heart result in a movement of the heart as well as of all the arteries as they expand with each heart contraction.
    ECG is used to allow the system to compensate for this movement. In order to obtain useful MRI images, the taking of the MRI images is adjusted in time to correspond to the beats of the patient's heart, so that each image is taken at the same time in the cardiac cycle. For example, the MR1 device can be adapted for taking pictures during diastole, which is the relaxation phase of the heart. Similarly, the transmission of HFU treatment is adjusted in time to the cardiac cycle by using the ECG monitoring device 30. After identifying the target position by means of an MRI image, HFU treatment is applied to the target position. To ensure the correct positioning of the target position during treatment, the point during the cardiac cycle at which the MRI image is taken is the same as the point at which HFU treatment is delivered. In this way, the target position that has been identified using MRI is the same as the position to which the HFU treatment is delivered.
    ECG data is passed to a processor device 50 during processing. Processor device 50 interprets ECG data and provides instructions to the MRI device 40 and the HFU controller 80. The processor device 50 also receives data from the MRI device 40 and includes the image recognition device 60 and an image display device 70. The image recognition device 60 can be used to identify plaque in the arteries by interpreting the signal in the MRI images. Alternatively, a clinician may visually identify plaques on the MRI images on the image display device 70. In some embodiments, the image recognition device 60 identifies the plaques and the clinician verifies the identification using the image display device 70.
    The image recognition device 60 and / or the clinician identifies the position of the base of each plaque targeted for the HFU treatment.
    After one or more target positions have been identified by the processor device 50 and / or the clinician, a treatment plan is developed. A single plaque may include a target position or multiple target positions along the base of the plaque. In addition, an individual may have multiple plaques. In some cases, the treatment plan includes sending HFU to all identified plaque bases. In other cases, it may be desirable to selectively treat only some plaque bases or portions of plaque bases and leave others untreated. Therefore, the treatment plan includes the decision regarding which plaque bases are to be treated, and these positions become the target positions. For each target position 10 15 20 25 30 536 526, the ideal alignment of the HFU device 20 and the patient 10 must also be determined. This will depend on the position of the target position as well as on factors such as the anatomy of the individual patient.
    The following parameters depend on the size and position of the plaques as imaged by the MRI device 40: - specific emission angle or emission position, - the intensity of the ultrasonic energy waves to be dispensed, and - the duration of transmission of the ultrasonic energy waves. In some cases, treatment may be delivered by a stationary HFU beam from a single angle. Alternatively, it may be advantageous to dispense HFU to a target position by using a stationary HFU beam from more than one treatment angle. In some cases, HFU may be dispensed as the beam rotates along an arc of treatment angles. In still other cases, HFU can be distributed from several arcs of treatment angles. This can be achieved through a multi-position converter. The method includes the step of moving the source of said beam. The movement can be linear or angular. By transmitting treatment from more than one treatment angle, the amount of energy supplied to the tissue outside the target position can be minimized and therefore the risk of damage to other tissue can be reduced or eliminated. For each treatment angle and for each target position, a target temperature must be selected. Therefore, the treatment plan includes details regarding which target positions are to be treated, the angle from which HFU is to be distributed, whether several treatment angles are to be used for transmitting HFU to a target position or not, and what the final temperature for the target position is to be for each HFU transmitter. - ning. The transmission of ultrasonic energy waves is either intermittent or pulsed where the source of the ultrasonic transmission is moved after each pulse or after a series of pulses. The transmission angle can be constant or change after each pulse or a series of pulses. These decisions can be made by the processor device 50 according to guidelines in its programming, by a clinician, or by the clinician in combination with the processor device 50.
    The transmission of HFU along an arc of treatment angles can be either rotary or stationary. When the treatment plan asks for rotating HFU transmission along an arc of angles, HFU treatment is dispensed while the HFU device is actively moving. However, rotary transmission of HFU treatment of the arteries can only be provided during a specific time window in each cardiac cycle due to the movement of the arteries. Therefore, the arc for rotational therapy can be formed as a series of mini arcs, where treatment is distributed when the HFU device rotates through a series of mini arcs with each heartbeat. For example, treatment during a first heartbeat may begin at a first angle and rotate to a second angle, thus forming a first mini-arc. At the next heartbeat, treatment can be resumed at the second angle and rotated to a third angle, thus forming a second mini-arc following the first mini-arc. The treatment can thus continue to rotate along the mini arcs until the mini arcs together form the planned treatment arc. Alternatively, stationary processing can be delivered along an arc of angles without rotation during HFU transmission. For example, treatment may be given during a first heartbeat by a stationary HFU beam from a first angle. The HFU device can be adjusted slightly, such as 1 millimeter, and during a second heartbeat, the treatment can be delivered by the stationary HFU device from a second angle which may be close to the first angle. The HFU device can continue to adjust to the following treatment angles until the treatment has been transmitted from a series of angles forming an arc of treatment angles.
    An alternative is a multi-position converter that is adjusted in size and format to the target vessel or an arc with more than one converter that emits energy in a continuous manner.
    The processor device sends instructions according to the processing plan to the HFU control device 80 which controls the HFU transmission device 20. When the HFU transmission device 20 is inside the MRI device 40, it must not include any iron-containing material. During treatment, the treatment side of the HFU dispensing device 20 is in contact with the outside of the patient 10, either directly or through an intermediate material such as a gelled patch, for example on the patient's neck, groin or chest. When a gelled patch is used, it can be compressed to correct the distance between the patient's outside and the target position in the vessel. The use of a gelled patch may therefore be suitable for treatment plans requesting rotational transmission of HFU treatment along a treatment arc, so that the distance between the HFU device and the target position is kept constant while the HFU device rotates around the target position. The ultrasound transmitting device 20 is mobile and can be accurately positioned and angled relative to the patient 10 to direct the HF U exactly at the target position. The maximum distance between the ultrasonic emitting device 20 and the target position is preferably less than about 6 cm. This maximum distance can be taken into account when preparing a treatment plan.
    The HFU emitting ultrasound emitting device 20 emits ultrasonic waves to the target position at the base of the plaques, thereby causing the target position temperature to rise. The size of the HFU focal point is preferably less than about 15 mms. This can be achieved by using HFU waves with a frequency of between about 0.8 to about 4 Hertz and with a focus intensity of between about 500 to about 3000 W / cmz. The HFU emitting device 20 emits HFU to the target position in repeated short intervals which are correlated with a particular point in the cardiac cycle as detected by the ECG, according to instructions from the processor device 50. The duration of each HFU emission may be from about 80 milliseconds to about 1 second. The appropriate duration for each HFU transmission depends on the individual patient's heart rate. The duration of each HFU transmission may be a short duration that is appropriate for most or all patients regardless of the patient's heart rate. Alternatively, the duration of each HFU transmission can be determined for each individual patient depending on the measured heart rhythm. Finally, the duration of each HFU transmission may vary during each individual patient's treatment in response to measured heart rate. in the HFU dispensing device 20, the dispensing of HFU continues to the target position until the tissue reaches the desired temperature according to the treatment plan. In some embodiments, the maximum desired temperature in the target position is approximately 60 degrees Celsius. The temperature in the target position is determined by the processor device 50 based on images provided by the MRI device 40. To monitor the temperature rise, the system may periodically take MRI images during the processing process. For example, the system may take an MRI image after each transmission of HFU treatment. Alternatively, MRI images can be taken while sending HFU treatment. For example, an MRI image can be taken during the initial treatment and then repeated after several HFU pulses. The MRI images can then be repeated during the treatment to monitor the process. The signal in the MRI image at the target position changes in a way that corresponds to the temperature of the tissue. The processor device 50 includes a device that can interpret the changes in the MRI image of the target position to determine the temperature of the tissue. When the desired temperature is reached, the processor device 50 instructs the HFU controller 80 to interrupt the transmission of the HFU.
    Figure 2 shows a treatment method according to embodiments of the invention. Treatment begins at the start, step 100. In step 102, MRI images of the coronary arteries are taken. The MRI images are used to identify plaques and target positions at the base of the plaques in step 104. Based on the MRI images, a treatment plan is prepared in step 106 by the processor device and / or the clinician. HFU treatment is then applied in step 108 to the precise position in the vessel wall by means of either a stationary beam or a rotating beam. MR1 imaging of the target position is performed in step 110. The MRI image is processed in step 112 to determine whether the desired temperature according to the treatment plan has been reached or not. If the desired temperature has not been reached, the steps of HFU processing 108, MRI imaging 110, and MR1 imaging 112 are repeated until the desired temperature is reached.
    A determination of whether or not the processing plan requests additional processing angles or arcs of processing angles to the target position is performed in step 114. If an additional processing angle or arc of angles is planned, the starting position is adjusted and the initial angle of the HFU transmitter in step 116 and HFU processing is applied. in step 108 to the same target position from a new angle. MR1 imaging and image processing are repeated in steps 110 and 112 until the desired temperature is reached using the new angle of the HFU device.
    When no further processing angles are planned for one target position, in step 118 a determination is made as to whether further processing is planned for another target position or not. If no processing is planned for 10 10 15 20 25 30 536 526 other target positions, the processing is completed in step 122. However, if further processing positions are planned, the position of the HFU device is adjusted in step 120 for sending HFU to a new target position, and the procedure is repeated for the new treatment position. This is repeated until all planned target positions have been processed.
    By applying HFU to the base of the plaque, the target tissue in the vessel wall undergoes a temperature increase. This increase in temperature leads to inflammation in the tissue and at a later stage to scarring which is sufficient to reduce or destroy the vaso vasorum, which is the vascular supply to the base of the plaque. It is considered that the loss of vascularization to the vessel wall at the base of the plaque leads to a final regression of the plaque. Because the HFU ultrasound is very accurate, it can transfer energy to the base of the plaque without damaging the vessel wall. In this way, HFU treatment can be used to reduce and eliminate plaque non-invasively.
    Embodiments of the invention treat atherosclerosis disease non-invasively using targeted ultrasound therapy and thus avoid the risks associated with invasive procedures. In addition, by avoiding surgery, the treatment procedure is simpler for the patient and the clinician, and can be performed more quickly and includes less patient discomfort and results in a faster and easier recovery. Furthermore, the procedure offers a treatment option for patients who are not qualified for a surgical procedure. Although some embodiments of the invention are suitable for use in large arteries, the treatment may also be performed to reduce atherosclerosis elsewhere in the body, including the coronary arteries.
    The imaging cardiac ablation procedure and system can potentially be used in the following vascular applications: for the elimination of atherosclerosis, including removal of atherosclerotic plaques, typically in the femoral artery, carotid artery, renal artery or coronary artery.
    It can also be used to eliminate thrombolysis, which includes intracranial thrombosis, thrombosis in hemodialysis shunts, left atrial thrombosis (LAA), venous thrombosis, and pulmonary embolism. It can further be used to eliminate vascular blockages, typically in medical conditions such as bleeding, occlusion of punctures, varicose veins, pseudoaneurysm, vascular malformations in the brain, and bloodless resection of organs, bleeding esophageal varicose veins, and also for the separation of twins who share the same placenta. The imaging cardiac ablation procedure and system may be extended for use in the following non-vascular applications: for malignant conditions including prostate cancer, breast cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, pancreatic cancer, and osteosarcoma. It can also be used in other non-vascular applications that do not involve malignant conditions such as benign prostatic hyperplasia, uterine fibroids, fibroadenoma (breast, liver).
    Furthermore, the blood-controlled cardiac ablation procedure and system can be used for the treatment of glaucoma, pain treatment, treatment of functional disorders of the brain (epilepsy, Parkinson's disease), lithotripsy (urinary stones, gallstones), vasectomy, synovectomy (in rheumatoid arthritis), skin lesion recovery ( valve dystrophy, lymphatic drainage, skin care) and also in cases involving atrial fibrillation (MAZE procedure).
    It can also be used in targeted gene therapy and drug delivery applications. Although considerable emphasis has been placed on specific elements of the preferred embodiment, it will be appreciated that many changes may be made and that many modifications may be made in the preferred embodiment without departing from the principles of the invention. These and other changes in the preferred embodiment, as well as other embodiments of the invention, will become apparent to those skilled in the art from the description, whereby it will be readily understood that the foregoing descriptive substance is to be construed as illustrative only of the invention and not as a limitation. 12
    权利要求:
    Claims (15)
    [1]
    A system for non-invasive raising of the temperature of tissue using ultrasonic energy waves, comprising: at least one ultrasonic emitting device (20) arranged to transmit ultrasonic energy waves to a focal point of target tissue, a temperature monitoring device for monitoring the temperature of target tissue, and a ) for operating and controlling the ultrasonic emitting device (20) for emitting ultrasonic energy waves at a focal point of less than about 15 mms and with an intensity focus for said ultrasonic energy waves in the range from about 500 W / cmz to 3000 W / cmz, for raising the temperature of target tissue to a desired temperature.
    [2]
    The system of claim 1, further comprising an imaging device (40) adapted to provide an image of at least a portion of a mammalian body.
    [3]
    The system of claim 1 or 2, wherein the imaging device (40) is a magnetic resonance imaging device.
    [4]
    A system according to any one of claims 1 to 3, further comprising an image recognition unit (60) arranged for determining the position of at least one vascular plaque in said image and for determining a position for the base of said vascular plaque, which device further determines one or more target positions at the base of the plaque.
    [5]
    A system according to any one of claims 1 to 4, wherein said ultrasonic emitting device is a multifocus converter. 13 10 15 20 25 30 536 526
    [6]
    The system of claim 5, wherein the ultrasonic emitting device is made of non-ferrous material and is located in said magnetic resonance imaging device.
    [7]
    A system according to any one of claims 1 to 6, wherein the ultrasonic emitting device is arranged for movement in angular direction and / or linearly.
    [8]
    The system of any one of claims 1 to 7, further comprising a monitoring device (30) for monitoring the relative position of target tissue with respect to heart rhythm.
    [9]
    A system according to any one of claims 1 to 8, wherein the control unit is arranged to receive, by manual intervention and / or from an automatic control unit, a therapeutic treatment plan regarding the parameters for emitting energy waves.
    [10]
    A system according to any one of claims 1 to 8, wherein the control unit (80) is arranged to control said ultrasonic emitting device (20) for transmitting intermittently pulsed ultrasonic energy waves.
    [11]
    The system of claim 10, wherein the controller (80) includes a timing device for determining the start and stop of each pulse relative to the heart rhythm.
    [12]
    A system according to any one of claims 1 to 11, wherein the ultrasonic transmitting device (20) is a high frequency ultrasonic device with energy waves in the range between about 0.8 MHz and about 4 MHz.
    [13]
    A control unit (80) for an ultrasonic emitting device (20) emitting an ultrasonic beam to a focal point of a target object, the focal point of the energy waves being less than about 15 mms and the control unit being arranged to control said ultrasonic emitting device for emitting energy between about 500 W / cm 2 and about 3000 W / cm 2 to about 3000 W / cm 2 to said focal point for raising the temperature in the target position to a desired temperature, and which control unit further comprises a data processing device (50) for determining the target temperature at the focal point based on image data received from a temperature monitoring device.
    [14]
    A method of preparing a plan for non-invasively raising the temperature of tissue in a vessel wall, leading to a regression of vascular plaques, comprising the steps of: imaging at least a portion of a body to produce an image, determining the position of at least one vascular plaque in said image, determining the position of the base of said vascular plaque and one or more target positions at the base of the plaque, determining the parameters for emitting ultrasonic energy waves from a source to a focal point of less than about 15 mm an intensity focus for said ultrasonic energy waves in the range between about 500 W / cmz to about 3000 W / cmz for raising the temperature of target tissue in the vessel wall to a desired temperature sufficient to reduce or destroy vaso vasorum.
    [15]
    The method of claim 14, wherein the frequency of the ultrasonic energy waves is between about 0.8 MHz and about 4 MHz. 15
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    同族专利:
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    ZA200908955B|2011-02-23|
    BRPI0811688A2|2015-10-06|
    PL390174A1|2010-07-05|
    SE1050075A1|2010-03-22|
    EP2214785B1|2017-01-11|
    ES2398416A1|2013-03-19|
    RU2010102039A|2011-07-27|
    GB201001185D0|2010-03-10|
    CZ201060A3|2014-03-12|
    CN101754784A|2010-06-23|
    RU2486934C2|2013-07-10|
    CA2691764C|2014-12-23|
    AU2008269151B2|2012-11-01|
    KR20150048895A|2015-05-07|
    DK201000053A|2010-01-25|
    CU23790A3|2012-03-15|
    IL202896A|2013-12-31|
    PT2009002492W|2010-10-12|
    JP2010531165A|2010-09-24|
    DK177569B1|2013-10-28|
    NZ582789A|2012-11-30|
    WO2009002492A1|2008-12-31|
    US20150352379A1|2015-12-10|
    US9144693B2|2015-09-29|
    TN2009000541A1|2011-03-31|
    DOP2009000290A|2010-04-15|
    AT507375A2|2010-04-15|
    EP2214785A1|2010-08-11|
    GB2463617C|2013-05-22|
    BRPI0811688B1|2019-12-24|
    HK1145072A1|2011-04-01|
    US9630030B2|2017-04-25|
    US20090048546A1|2009-02-19|
    DE112008001685T5|2010-06-10|
    CA2691764A1|2008-12-31|
    BRPI0811688B8|2021-06-22|
    KR101640424B1|2016-07-18|
    KR20100044794A|2010-04-30|
    FI20105060A|2010-03-24|
    AU2008269151A1|2008-12-31|
    TR200909734T2|2010-06-21|
    AT507375A3|2012-10-15|
    GB2463617A|2010-03-24|
    ES2398416B1|2014-01-27|
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    法律状态:
    2021-10-05| NUG| Patent has lapsed|
    优先权:
    申请号 | 申请日 | 专利标题
    US94599307P| true| 2007-06-25|2007-06-25|
    PCT/US2008/007842|WO2009002492A1|2007-06-25|2008-06-24|Image guided plaque ablation|
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