| 词条 | Sonalleve MR-HIFU | ||||||||||||||||||||||||||||||||||||||||
| 释义 |
Technology overviewThe Sonalleve high frequency focused ultrasound uses a special transducer to focus a beam of ultrasound waves on to the fibroid located within the body. The focused ultrasound waves generate high temperatures within smaller areas. The temperature when maintained for sufficient a period of time results in the ablation of the fibroids. The therapy procedure guided by Magnetic Resonance Imaging (MRI) with real time feedback helps in the focused ablation of the target location.[3] The real-time feedback loop ensures that adequate heating takes place, treating every bit of tissue that has been targeted and volumetric ablation (a Philips proprietary technology) helps treat larger volumes efficiently and quickly.[4] Device approvalsThe Sonalleve is approved for treating uterine fibroids in Europe, most of Asia, the Middle East and South America. Philips has received CE Marking for its Sonalleve MR-HIFU system. Equivalent to Food and Drug Administration (FDA) approval in the U.S., CE Marking is recognized by countries in the European Economic Area, Asia, South America and Africa and signifies that a product complies with the essential requirements of relevant health, safety and environmental protection legislation.[5] The company has also applied for FDA approval for the system.[6] The process for clinical trials and study are already underway.[7] The device is also approved for the treatment of bone metastasis[5] and is undergoing development for the treatment of prostate cancer and breast cancer.[8] Treatment procedureThe method is quicker and comfortable compared to the conventional procedures currently done for the treatment of uterine fibroids such as hysterectomy, myomectomy or uterine artery embolization. The procedure is usually done on an outpatient basis with the patient leaving the hospital on the same day.[9] The patient may be kept for observation for another 24 hours. The procedure is performed in three stages:[9] Planning stageThe patients are evaluated using three dimensional MR imaging which is used to determine if the patient is eligible for treatment. If the patient satisfies the criteria for treatment, the condition is evaluated and the treatment time is planned accordingly. The patient arrives at the stipulated time and is placed in a prone position on the MRI table. The device is positioned correctly so as to achieve acoustic coupling and the regions of treatment are marked using the MR images. The patient may also be given IV fluids or conscious sedatives. A test delivery of a non lethal dose of ultrasound waves may also be focused to ensure accuracy. Non-invasive treatment stageHigh-intensity ultrasound waves are focused onto the fibroids which elevates its temperature and causes the tissue to coagulate. The process is done in multiple sonications with the number and duration depending on the size and extent of fibroids. The process will be closely monitored and controlled by MR imaging and feedback to confirm the accuracy and effectiveness of the treatment. In case of any discomfort, the patient can stop the process through a hand held device button. Therapy verification stageAt the end of treatment, contrast enhanced MR imaging is used to assess the effectiveness of the procedure. These images are used to determine the Non-Perfused Volume (NPV) of the fibroid, which is the volume of tissue that is non-viable (has no blood flow to it).[10] Treatment setupThe Sonalleve MR-HIFU system uses the Philips Achieva 1.5T, 3.0T MR, 3.0T TX or Philips Ingenia 1.5T, 3.0T platform,[11] and comprises the following interconnected subsystems:
Treatment benefitsFor the doctors it offers easy planning, treatment with real-time feedback and a solution to those who would otherwise decline surgical treatment. For the patients it offers an alternative non-invasive treatment mechanism involving no anesthesia and a short recovery time. [9]LocationsThe system was initially installed in about 16 locations in the U.S., Europe and Asia for research purposes.[12] Philips has installed around 50 of its Sonalleve MR-HIFU systems worldwide with most of the systems in Asia and Europe.[8] India has seven installed systems in five cities.[13] Apollo Hospitals[14] has the setup installed at three of its facilities Chennai, Bangalore and New Delhi.[15] The treatment is also available in Clumax Diagnostics, Bangalore,[16] Bharat Scans, Chennai,[17] SRL Jankharia Imaging, Mumbai[18] and Sunrise Hospital, Kochi.
See also
References1. ^1 Philips FieldStength Issue 36 - December 2008 2. ^{{cite web|title=Philips expands collaboration with Profound Medical Corp. in MR-guided ultrasound ablation therapies|url=https://www.philips.com/a-w/about/news/archive/standard/news/press/2017/20170630-philips-expands-collaboration-with-profound-medical-corp-in-mr-guided-ultrasound-ablation-therapies5.html|website=Philips News Center}} 3. ^Philips FieldStength Issue 40 - May 2010 4. ^http://www.apollohealthcity.com/MRI%20guided%20HIFU/howhifuworks.html{{dead link|date=May 2018 |bot=InternetArchiveBot |fix-attempted=yes }} 5. ^1 {{cite web |url=http://www.fusfoundation.org/Blog/philips-sonalleve-receives-ce-mark-for-mr-guided-focused-ultrasound-ablation-of-metastatic-bone-cancer |title=Archived copy |accessdate=2012-05-07 |deadurl=yes |archiveurl=https://web.archive.org/web/20120510150313/http://www.fusfoundation.org/Blog/philips-sonalleve-receives-ce-mark-for-mr-guided-focused-ultrasound-ablation-of-metastatic-bone-cancer |archivedate=2012-05-10 |df= }} 6. ^{{cite web |url=http://www.fusfoundation.org/Newsletter-Articles/philips-prepares-for-launch-of-us-pivotal-trial-for-uterine-fibroids |title=Archived copy |accessdate=2012-05-07 |deadurl=yes |archiveurl=https://web.archive.org/web/20120302151900/http://www.fusfoundation.org/Newsletter-Articles/philips-prepares-for-launch-of-us-pivotal-trial-for-uterine-fibroids |archivedate=2012-03-02 |df= }} 7. ^{{cite web|url=http://www.clinicaltrials.gov/ct2/show/NCT01504308?term=philips%20fibroids&rank=1|title=Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids - Full Text View - ClinicalTrials.gov|author=|date=|publisher=|accessdate=23 September 2016}} 8. ^1 {{cite web |url=http://www.fusfoundation.org/Newsletter-Articles/asian-markets-are-leading-the-way-an-update-on-worldwide-focused-ultrasound-adoption |title=Archived copy |accessdate=2012-05-07 |deadurl=yes |archiveurl=https://web.archive.org/web/20120427114732/http://www.fusfoundation.org/Newsletter-Articles/asian-markets-are-leading-the-way-an-update-on-worldwide-focused-ultrasound-adoption |archivedate=2012-04-27 |df= }} 9. ^1 2 {{cite web|url=http://www.healthcare.philips.com/br_pt/products/mri/systems/sonalleve/|title=Philips Health Care - Cuidados com a Saúde|author=|date=|publisher=|accessdate=23 September 2016}} 10. ^{{cite journal |vauthors=Stewart EA, Gostout B, Rabinovici J, Kim HS, Regan L, Tempany CM |title=Sustained relief of leiomyoma symptoms by using focused ultrasound surgery |journal=Obstet Gynecol |year=2007 |volume=110| issue = 2 pt 1 |pages=279–287 |pmid= 17666601 |doi=10.1097/01.AOG.0000275283.39475.f6 }} 11. ^{{cite web|url=http://www.healthcare.philips.com/main/products/mri/systems/sonalleve/specifications.wpd|title=Philips Healthcare - Magnetic Resonance|author=|date=|publisher=|accessdate=23 September 2016}} 12. ^http://clinical.netforum.healthcare.philips.com/us_en/Explore/Clinical-News/MRI/Investigational-Sonalleve-MR-HIFU-system-showcased-at-ISMRM 13. ^{{cite web|url=http://www.life-uninterrupted.com/treatment-centers|archive-url=https://web.archive.org/web/20120918055942/http://www.life-uninterrupted.com/treatment-centers|dead-url=yes|archive-date=18 September 2012|title=Life Uninterrupted « Life is beautiful, fun and grace|author=|date=|publisher=|accessdate=23 September 2016}} 14. ^http://www.apollohospitals.com/uterine_fibroids.php 15. ^{{cite web|url=https://www.youtube.com/watch?v=vLNrzyPrODg|title=Apollo Hospitals Announces the Launch of Breakthrough Technology HIFU|first=|last=hyderabadhealthcare|date=27 August 2011|publisher=|accessdate=23 September 2016|via=YouTube}} 16. ^{{cite web |url=http://www.biospectrumasia.com/content/041011IND17207.asp |title=Archived copy |accessdate=2012-05-07 |deadurl=yes |archiveurl=https://web.archive.org/web/20111007115807/http://biospectrumasia.com/content/041011IND17207.asp |archivedate=2011-10-07 |df= }} 17. ^{{cite web|url=https://www.youtube.com/watch?v=1trFoAqKMj4|title=Bharat Scans Xmas & New Yr Celebration 2012 Presentation By Mr. Krishna Kumar (Philips)|first=|last=Subramanian Ramanathan|date=12 January 2012|publisher=|accessdate=23 September 2016|via=YouTube}} 18. ^http://modernmedicare.co.in/3378/srl-diagnostics-%E2%80%93-jankharia-imaging-announces-the-launch-of-hifu-technology-for-treatment-of-uterine-fibroids.html{{dead link|date=May 2018 |bot=InternetArchiveBot |fix-attempted=yes }} External links
1 : Female genital procedures |
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