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Saturday, May 30, 2015

PENTAXライフケア: 微創手術軟體到硬體整合 (i-SCAN Virtual chromoendoscopy & マルチファンクション Splash M-Knife)

HOYA株式会社PENTAXライフケア事業部 新製品『PENTAX Medical 高周波ナイフ DN-Dシリーズ (愛称Splash M-Knife)』を販売開始May 25, 2015 01:07 AM Eastern Daylight Time 東京--(BUSINESS WIRE)--(ビジネスワイヤ) -- HOYA株式会社PENTAXライフケア事業部は、2015529―31日に名古屋で開催される第89回日本消化器内視鏡学会総会において、新製品『PENTAX Medical 高周波ナイフ DN-Dシリーズ (愛称Splash M-Knife)』を発表し、日本国内で販売開始いたします。「日本をはじめ世界でのESD普及の促進が、癌の早期治療や医療費の課題解決に貢献すると考え、革新的なデザインのマルチファンクションデバイス、Splash M-Knifeを上市します。ESDをより安全、確実に、かつ効率よく行えることが、低侵襲医療のさらなる普及と発展につながることを期待します。」軟性内視鏡は処置具と組み合わせることで、病変部分の粘膜組織を採取したり、その場で治療を施すなど、「見る」だけでなく低侵襲医療に不可欠な医療機器として発展を遂げています。例えば内視鏡的粘膜下層剥離術(Endoscopic Submucosal Dissection、以下ESD)は、内視鏡先端から出したナイフを使い、消化管にある病変を取り除く技法です。この技法は日本では10年以上前から行われてきましたが、術後の回復が早く、合併症を引き起こすおそれが低減されるなど、患者様への便益が大きく、また医療費の抑制にもつながるため、世界中の医療現場に採用されつつあります。プロダクトマネジメント統括部ヴァイス・プレジデント、ラミ・リーベンザルは、「日本をはじめ世界でのESD普及の促進が、癌の早期治療や医療費の課題解決に貢献すると考え、革新的なデザインのマルチファンクションデバイス、Splash M-Knifeを上市します。ESDをより安全、確実に、かつ効率よく行えることが、低侵襲医療のさらなる普及と発展につながることを期待します。」と述べています。

特徴1:マルチファンクション Splash M-KnifeESDにおけるさまざまなシチュエーションに対応可能なマルチファンクショナルデバイスで、マーキングからプレカット、粘膜切開・剥離、止血に至るまで、ESDで求められる手技を一本で行うことができます。

特徴2:独自の先端形状 ナイフ部に採用したディスクチップ(突起部)により、スムーズな切開・剥離をサポートします。電極の接触面が広いため速やかな止血対応が可能となり、止血デバイスへの入れ替え頻度を低減します。

特徴3:送水機能 ナイフ先端からの送水により、視野の確保や出血点の確認が可能です。ナイフ先端に付着する組織などを適宜洗浄することにより、ナイフ切開能の低下を抑えます。

HOYA株式会社PENTAXライフケア事業部について PENTAXライフケア事業部は、HOYA株式会社の医療用内視鏡を扱う事業部です。高い品質、医療ニーズに応えるイノベーション、そしてシンプルさを追求した最良の内視鏡製品群とサービスを提供することで、患者さまのケアと医療の生産性向上に寄与することをミッションとしています。 最先端の研究開発と生産技術を通じ、当事業部はPENTAX Medical のブランド名で内視鏡システムとソリューションを世界の医療産業に提供しています。日本国内にある生産設備およびグローバル本部に加え、世界各地に研究開発、販売、サービスの拠点を擁しています。詳しくはウェブサイトをご覧ください。www.pentaxmedical.com

Contacts お問い合わせ先: HOYA株式会社 PENTAX ライフケア事業部 医用機器SBU グローバルマーケティング統括部 マーケティングコミュニケーション部長 川島 香織 Email: kaori.kawashima@pentaxmedical.com 携帯: 080-4794-5842 196-0012 東京都昭島市つつじが丘1-1-110


豪雅集團旗下 PENTAX Medical上市用於胃癌早期治療的新款多功能內視鏡黏膜下剝離器材Splash M-Knife(中央社訊息服務20150527 15:17:32)東京--(美國商業資訊)--豪雅集團旗下PENTAX Medical上市新款多功能內視鏡黏膜下剝離器材Splash M-Knife,以實現透過單件器材完成完全性內視鏡黏膜下剝離術(以下簡稱ESD)。該新款器材將在日本消化器內視鏡學會(JGES) 89屆年會上展示,該年會將於201552931日在日本名古屋召開。開發可彎曲內視鏡旨在與其他治療器材一起用於各類微創治療手術。ESD是十多年前日本發明的一種手術,由於其具有臨床和經濟效益,有助於早期恢復、降低複雜性和成本,因而已在世界各地普及。全球產品管理副總裁Rami Liebenthal做出如下評論:「我們正在上市Splash M-Knife,這是一種創新的多功能ESD器材,它有助於ESD的全球普及,加快胃癌的早期治療。我們相信,用於精確、高效率、更安全ESD的創新器材為展開完全性ESD治療設立了一個新標準。我們致力於推廣該手術及其進一步的開發。」

Splash M-Knife具有下列特點1.多功能 它可實現清晰的標記、更好的止血、更順利更輕鬆的手術,手術過程中無需替換刀具。2.獨特的機制 刀具中的碟片可幫助鉤起組織,從而提高安全性、便於切割,而貼近刀具的金屬板可實現清晰的標記和更好的止血3.噴水功能 它無需改變器材即可實現額外的注射

關於PENTAX Medical PENTAX Medical隸屬於豪雅集團 (HOYA Group) 。我們的使命是透過提供注重品質、貼合臨床的創新和簡單易用的最佳內視鏡產品和服務來改進患者治療和醫療衛生服務品質的標準。PENTAX Medical透過領先地位的研發和製造,為全球醫療界提供內視鏡成像設備和解決方案。總部位於日本的PENTAX Medical服務於全球,其研發、地區銷售、服務和駐在國設施遍及全球。欲瞭解更多資訊,請造訪www.pentaxmedical.com


Splash M-Knife

 


i-SCAN Virtual chromoendoscopy


    







Reference: Diagnostic and Therapeutic Endoscopy, Volume 2012 (2012), Article ID 193570, Use of i-scan Endoscopic Image Enhancement Technology in Clinical Practice to Assist in Diagnostic and Therapeutic Endoscopy: A Case Series and Review of the Literature

Duodenoscope (十二指腸內視鏡) 成為超級細菌媒介 (Carbapenem-resistant Enterobacteriaceae, CRE)??

FDA reveals 142 cases of tainted scopes Scopes Deadly bacteria can become trapped at the tip of duodenoscopes. (LIZ MARTIN / The Gazette) By CHAD TERHUNE AND MELODY PETERSEN   Business Medical Research Hospitals and Clinics Food and Drug Administration CRE Infections UCLA Medical System The number of patients involved could be far higher than 142 Officials said 669,000 medical scope procedures were performed last year on patients Both the FDA and Olympus Corp., the leading maker of duodenoscopes, have come under fire. Federal regulators shed more light on the potential harm to patients from a controversial medical scope, disclosing 142 reports of contaminated devices and possible patient infections since 2010. The Food and Drug Administration had previously said it received about half that many reports, 75, on duodenoscopes that caused patient infections in 2013 and 2014. The number of patients involved could be far higher than 142 because one adverse event report may include numerous people. The new details emerged this week in advance of an advisory panel the FDA is convening next week to examine recent scope-related superbug outbreaks at several U.S. hospitals, including ones at UCLA and Cedars-Sinai medical centers. That FDA panel of medical experts is expected to recommend further steps that regulators, device manufacturers and hospitals should take to protect patients undergoing a procedure known as endoscopic retrograde cholangiopancreatography, or ERCP. Officials said 669,000 ERCP procedures were performed last year on patients battling cancer, gallstones and other digestive issues. Both the FDA and Olympus Corp., the leading maker of duodenoscopes, have come under fire from federal lawmakers, doctors and patient advocates for not responding sooner and more forcefully to reports of hospital outbreaks. Patients were infected even though hospitals were following the manufacturers' recommended cleaning instructions. Health officials have found that deadly bacteria can become trapped at the tip of these duodenoscopes. "The transmission of infectious material from patient to patient during ERCP, although uncommon, represents a serious public health concern," the FDA said in its latest report. Federal officials acknowledged that their surveillance system for medical devices has limitations and that incidents can be underreported by manufacturers. Some medical experts agree, and they say the number of scope-related infections may be much higher. "These reports can come in 18 months to two years later," said Lawrence Muscarella, a hospital-safety consultant in Montgomeryville, Pa. The FDA's new figures "could significantly underestimate the risk." After a superbug outbreak became public in February at UCLA's Ronald Reagan Medical Center, the FDA issued a nationwide alert to hospitals and Olympus published revised cleaning instructions. At UCLA, contaminated Olympus scopes infected seven patients with the CRE superbug and two of them died. Cedars-Sinai reported a similar outbreak in March that sickened four patients treated with an Olympus scope. Carbapenem-resistant Enterobacteriaceae, or the superbug CRE, is highly resistant to antibiotics, and it can kill up to half of those infected. A spokesman for Olympus couldn't be reached for comment Wednesday. In preparation for the advisory panel debate, the FDA searched its database of adverse event reports filed by scope manufacturers as well as from the makers of equipment that hospitals use to disinfect endoscopes. Regulators said they found 142 reports related to duodenoscopes from 2010 to Feb. 17, 2015. There were four additional reports going back to 1997. Among that total of 146 incidents, 13 involved patient deaths and 121 dealt with injuries, according to the FDA. The other reports involved equipment malfunction or other unspecified outcomes. An FDA spokeswoman said she didn't have a figure for the total number of patients involved in the ERCP reports. She said the agency didn't want to comment further in advance of the advisory panel meeting May 14 and 15 Olympus holds an 85% share of the U.S. market for duodenoscopes and other specialty endoscopes, according to the FDA. The FDA said six of the nine outbreaks recently investigated by health officials involved Olympus duodenoscopes. Scopes from Pentax Medical were involved in two outbreaks, and those from Fujifilm were involved in one, according to the FDA. "There is a systemic risk from this instrument. The problem of underreporting is probably high," said Dr. James McKinnell, an expert on hospital epidemiology at the L.A. Biomedical Research Institute at Harbor-UCLA Medical Center. The FDA continued to stand by its decision to not recall the duodenoscopes. "The agency believes that removal of the device from the market could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the United States," the agency said in its report. "FDA believes the benefits of the ERCP procedure outweigh the risks in appropriately selected patients." The FDA also disclosed for the first time the number of reports it had received on patient infections and device contamination related to automated endoscope reprocessors, the machines many hospitals use to disinfect these reusable devices. The agency said it had 152 adverse event reports related to reprocessing equipment from 1992 to March 2015. Custom Ultrasonics, a leading manufacturer of reprocessing machines, has previously said it's monitoring the scope infections closely, but it has "no concerns regarding the safety and efficacy of our devices." Overall, the number of ERCP procedures in the U.S. has grown 15% since 2010 to 668,800 last year, according to industry research cited by regulators.

ERCP (Endoscopic Retrograde Cholangio-Pancreatography) Patient Information from SAGES

What Is ERCP (Endoscopic Retrograde Cholangio-Pancreatography)? ERCP is a procedure that enables your surgeon to examine the pancreatic and bile ducts. A bendable, lighted tube (endoscope) about the thickness of your index finger is placed through your mouth and into your stomach and top part of the small intestine (duodenum). In the duodenum a small opening is identified (ampulla) and a small plastic tube (cannula) is passed through the endoscope and into this opening. Dye (contrast material) is injected and X-rays are taken to study the ducts of the pancreas and liver.

Why Is An ERCP Performed? ERCP is most commonly performed to diagnose conditions of the pancreas or bile ducts, and is also used to treat those conditions. It is used to evaluate symptoms suggestive of disease in these organs, or to further clarify abnormal results from blood tests or imaging tests such as ultrasound or CT scan. The most common reasons to do ERCP include abdominal pain, weight loss, jaundice, or an ultrasound or CT scan that shows stones or a mass in these organs. ERCP may be used before or after gallbladder surgery to assist in the performance of that operation. Bile duct stones can be diagnosed and removed with an ERCP. Tumors, both cancerous and noncancerous, can be diagnosed and then treated with indwelling plastic tubes that are used to bypass a blockage of the bile duct. Complications from gallbladder surgery can also sometimes be diagnosed and treated with ERCP. In patients with suspected or known pancreatic disease, ERCP will help determine the need for surgery or the best type of surgical procedure to be performed. Occasionally, pancreatic stones can be removed by ERCP.

CRE抗藥性檢測 (衛生福利部 疾病管制署)

一、 檢測目的 carbapenem類抗生素屬於強力的廣效性β-lactam類藥物,通常被視為治療多重抗藥性細菌的最後防線;但近年來革蘭氏陰性菌,尤其是腸道菌(Enterobacteriaceae),對carbapenem類抗生素產生抗藥性(carbapenem-resistant Enterobacteriaceae, CRE)的比例日增,因此受到國際間的高度關注。為協助醫療機構確認藥敏試驗結果及檢測是否帶有NDM-1基因等,並收集國內菌株了解相關抗藥性機制,故提供此通報項目。二、通報方式(一)採志願通報。(二)倘醫療院所於病患臨床檢體分離出CRE,需協助鑑定或進行抗藥性基因檢測者,可經由傳染病通報系統之「其他傳染病」項下「CRE抗藥性檢測」辦理通報及送驗。三、送驗條件(一)對carbapenem類抗生素(doripenemimipenemmeropenemertapenem)任一種不具感受性(nonsusceptible)之腸道菌(Enterobacteriaceae)。因某些細菌本身即對imipenem不具感受性(nonsusceptible),則需以其他carbapenem(如:doripenemmeropenemertapenem)進行藥敏試驗。且(二)對以下任一第三代頭孢子菌素類 (third-generation cephalosporins)具有抗藥性: ceftriaxone, cefotaxime, and ceftazidime四、檢體採集運送(一)醫療院所應將臨床檢體所分離出具carbapenem抗藥性之腸道菌純化菌株,以cary-blair拭子沾滿一圈後,置入cary-blair保持輸送培養基,以採檢箱立即送至疾病管制局昆陽實驗室。(二)運送檢體應於常溫(22-35)儘速送驗。(三)本菌抗藥性高,採檢時應謹慎操作,避免污染環境。(四)菌株驗出NDM-1基因等陽性約須5-7

 





GeneWEAVE 開發快速超級細菌檢測 MDROs / MRSA, CRE, and FRE (Fluoroquinolone-Resistant Enterobacteriaceae)

GeneWEAVE Presents Data for Smarticles™ Assay Targeted Towards Carbapenem-Resistant Enterobacteriaceae (CRE)  Abstract Presented at SHEA 2015 Demonstrates Direct-from-Sample Detection of CRE Utilizing New Molecular Assay  (PRWEB) May 15, 2015  GeneWEAVE, Inc., a clinical diagnostics company addressing multi-drug-resistant organisms (MDRO), announced that initial data presented at the SHEA Spring 2015 Conference demonstrates the ability for its Smarticles™ technology to detect CRE directly from rectal swab samples regardless of the resistance mechanism and without the need for sample preparation or previous culture. This abstract was one of twenty-four outstanding abstracts selected for the SHEA Abstract Award poster presentation. The Company's Smarticles™ technology is a new class of molecular diagnostics that can quickly detect MDROs and assess antibiotic susceptibility directly from clinical samples. An abstract presenting analytical performance for a prototype Methicillin-Resistant Staphylococcus aureus (MRSA) assay tested directly from nasal swabs was previously presented at the AMP Annual Meeting in November, 2014."We are excited by this data that supports the application of Smarticles™ technology to Gram-negative bacteria. The logarithmic increase in resistance mechanisms and global rise in related infections speaks to the need for better surveillance and diagnostic tools," said Steve Tablak, CEO at GeneWEAVE. "In addition to ease of use, this poster indicates how our detection of molecular 'systems' can deliver fast and reliable susceptibility measurements regardless of the underlying resistance mechanism. These results suggest that even as bacteria develop novel resistance mechanisms, our tests will continue to provide reliable susceptibility data to enable successful infection prevention programs and personalized antibiotic selection." The emergence and spread of bacteria such as CRE and MRSA that are resistant to currently available antibiotics is a worldwide threat recently highlighted in the World Health Organization's (WHO) report, Antimicrobial Resistance Global Report on Surveillance 2014. As noted in a recent Centers for Disease Control and Prevention (CDC) publication, infections with CRE are particularly alarming as these have been associated with mortality rates up to 50%. Infections due to CRE are increasing at a rapid rate and have now spread to all but 2 states in the USA. Surveillance programs to identify patients that are asymptomatic carriers of drug-resistant bacteria are a key factor for controlling the spread of these organisms. Quick access to test results in the same shift is needed to ensure that infection prevention measures may be enacted promptly. With Smarticles™ technology, GeneWEAVE is developing fast, direct-from-patient-sample tests for critical MDROs such as MRSA, CRE, and FRE (Fluoroquinolone-Resistant Enterobacteriaceae) to allow healthcare providers to make time-critical decisions.

GeneWEAVE, Inc., based in Los Gatos, Calif., is a privately-held in vitro diagnostics company that is advancing clinical microbiology with diagnostic solutions to aid healthcare providers in the fight against drug-resistant bacteria by enabling impactful surveillance programs, early therapy guidance and successful antibiotic stewardship. The company's innovative and proprietary Smarticles™ technology harnesses the power of biology to rapidly detect drug resistance and measure susceptibility information without the need for enrichment, culture, or sample preparation. We call this new paradigm, "Sample-In/Susceptibility-Out".

 





狗狗DogTelligent 延伸: 開發夫妻忠貞戒指+APP 隨時監控!!


狗狗專用智慧型穿戴裝置!DogTelligent 推出萬能寵物項圈 作者 Jin Lin | 發布日期 2015 05 27 DogTelligent 幫助飼主實踐諾言,讓項圈不只是一個象徵物件,更能協助你隨時隨地掌握到愛犬的行蹤、安全和健康,甚至整合犬隻教育訓練,可以透過 App 遠距離對毛小孩發號司令。DogTelligent 是由一群愛狗人士組成的寵物科技產品研發團隊,致力於協助飼主為狗狗打造更好的生活,他們發揮創意將「寵物項圈」打造成一個多功能整合平台,與行動裝置和其他寵物產品結合。 DogTelligent 認為,安全是保護毛小孩的首要條件,他們獨創「虛擬圍欄牽繩科技」,讓項圈可以發出超聲波頻率和震動,好似一條在狗狗身上隱形卻可以無限伸長的牽繩,就算在遠距離也能做到拉繩效果,警告狗兒不該超出不安全的活動範圍;藉由 App 和項圈上的 GPS 定位系統,飼主不僅能掌握狗小孩的健康資訊、活動狀況和行動位置,在寵物失蹤的時候也能發揮最大功效!特別的是,項圈上設有 LED 燈增加我們在夜間搜尋寵物的能見度,更裝有揚聲器,讓緊張的飼主可以從手機的另一頭跟迷路的毛小孩說:「乖乖!坐下!我馬上就來找你!」。DogTelligent 的另一個亮點在於與專業犬隻訓練整合, DogTelligent 項圈除了震動功能外,還有超音波哨,在 App 上用戶可以自行設定不同的指令音哨(像是坐下、不要動、趴下等等),讓飼主直接使用行動裝置下達指令,在教育狗小孩的過程中配合使用;此外, DogTelligent 項圈還能偵測狗兒的激烈咆哮,代替飼主自動下達命令喝止。相較於前一陣子推出的LED燈光寵物背心 Disco Dog 著重於主人與寵物間的娛樂價值, DogTelligent 的產品更精准掌握住飼主的需求、簡化沒有必要的設計。目前線上也推出各種寵物科技,似乎間接證明智慧型穿戴裝置已經開始在寵物市場打出另一片天。而 DogTelligent 項圈不免讓人聯想到武打巨星李連杰在 2005 年推出的電影《鬥犬》,講述一個智商只有十歲的男人從小佩戴狗項圈,被黑社會訓練成殺人機器,片中項圈的意象備受爭議,對於寵物來說,控制性更強的項圈究竟是不是一件好事?如果這項科技應用在結婚戒指上,讓夫妻可以透過 App 監視彼此的忠貞度,聽起來的確令人毛骨悚然。類似 DogTelligent 這種寵物產品的推出,會不會降低我們對寵物的信任感?或是無意間讓主人減少與寵物之間最珍貴的互動?但正如智慧型手機的發明,人們可以更便捷掌握人際關係,科技使人們疏離、亦能讓人更親密,不論如何,最終的決定權還是在人類自己的身上。