Ranfac’s Breast Care System . 乳管攝影導管 . 乳房定位針 美實科技有限公司 (Medliance Ltd. )

Ranfac Corp. Introduction Precision Medical Instruments Since 1888 America’s Single Source Manufacturing Facility Work Closely with Medical Professionals Certified with ISO 13485, 93/42 EEC Compliance with FDA, CE 0086 registered Surgery, Radiology, Hematology

Radiology Ranfac’s Breast Care system 1.乳管攝影導管 2.乳房定位針 3.Biopsy needles

Galactography infusion unit (Introduction/Drainage catheter for Galactography) 乳管攝影導管

Nipple Discharge

The incidence of Nipple Discharge 5% of referrals, and of these about 5% will prove to have cancer (Devitt) 6.4% of referrals ( Hughes) 5.5% of breast consultation (BRIDGE) 9% of 10000 self-referrals (Seltzer) 6.6% referrals (Guy’s Hospital) 10 to 15 percent of women with benign breast disease and in 2.5 to 3 percent of women with breast cancer (MONICA MORROW, M.D. Northwestern University Medical School, Chicago, Illinois)

Estimate the Annual Patients No. of Abnormal Nipple Discharge in Taiwan 4800 (ND)* 50% = 2400 / annually 5%~10% 0f 2400 will be proved to have cancer

Galactography/Ductography 主要功能- (健保版) 乳頭有不正常分泌物之乳管及乳管內病灶之理學檢查 1.以極細的鈍針置入乳管內灌洗及引流,用於乳 房腫瘤及乳管病變之相關細胞及相關理學檢查 2.乳管內導入適當對比劑而取像: (乳管攝影-利用乳房攝影設備) 其影像用於診斷病灶及用於惡性病灶隨後之手 術之導路圖(roadmap)

The benefit of Galactography for Patients 使用技術 優缺點 傳統治療 (診斷) 方式 乳房攝影 超音波 擠壓式檢體 Biopsy 對於乳管有不正常分泌物之病患,如果有觸 摸不到的病灶,可能錯失早期治療之機會,或 施予不必要之切除,檢體診斷正確率亦低 (診斷)方式 +乳管攝影 乳管攝影 導管引流檢體 可診斷出較小(觸摸不出)的癌性(cancerous)或非癌性(non-cancerous)的病灶,因此可於早期予以移除 乳管攝影可將乳管內的病灶定位(identify the location), 提供外科醫師最小化及保留性的手術導引圖 導管引流檢體有較高的細胞學(Cytopathology)檢驗正確率,作為診斷依據 如果沒有診斷為癌化病灶,病患因此而放心

The function of Galactogram - Diagnosis of lesion 其影像用於診斷病灶及用於病灶隨後之手術之導路圖(roadmap)

The function of Galactogram - Diagnosis of lesion 其影像用於診斷病灶及用於病灶隨後之手術之導路圖(roadmap)

The function of Galactogram -Minimal invasive surgery 其影像用於診斷病灶及用於病灶隨後之手術之導路圖(roadmap)

診斷較小的癌性(cancerous) 或非癌性(non-cancerous)的病灶

乳管造影術 (Galactography) 是一項輔助性乳房攝影 (Mammography)，使用含碘造影劑自乳頭直接注射入乳管， 以分析乳管是否正常，對於婦女乳頭有不正常分泌，如出 血、漿液性分泌物等，可提供重要的影像診斷依據。本文收 集45 位乳頭有異常分泌的婦女，施以乳造影術結果分析出其原因為各種乳管異常，包括佔最多數的管內乳突瘤 (intrductal papilloma) 有 33% (15/45)，管內乳突狀瘤病 (intraductal papillomatosis) 15% (7/45)，乳管擴張症 (ductal ectasia) 13% (6/45)，纖維囊腫病 (fibrocystic disezse) 29% (13/45)，乳癌 5%(2/45)，正 常15% (2/45)，此結果相當有效地以影像學診斷找出病灶的 位置、原因及範圍，以幫助外科作進一步之處理，由於操作 方法簡單、容易、安全，臨床診斷價值頗獲肯定。 許清寅1　吳淑萍1　王道遠2 中華放射醫誌　1998；23(3)：93-97

If a duct excision without a prior contrast study is performed, the surgery may be unnecessary or more extensive than needed. Also, a blind duct excision has the potential to miss an intraductal lesion in a small peripheral duct. As many as 40% of ductal tumors have been found to lie in a nonsubareolar location, which may cause a lesion to be missed at surgery if a duct excision without preoperative galactography is performed Atlas of Mammography 3rd Edition© 2007 Lippincott Williams & Wilkins Chapter 14 Galactography

Galactogram國外的健保給付狀況

Galactogram國內的健保給付狀況 術碼: 特材:

Ranfac’s 乳管攝影導管特點 1. GIU-30, GIU-31, END-30, END-31 2. 提供全世界最細的彎直鈍針 30G, 31G 3. 安全、舒適、有保障(FDA及衛署核可) 4. 高健保給付、無需事前審查、無特定 適應症規範

Benefit of Galactography for Patients and Hospitals Early detection of breast lesion in ductal system Diagnose the cause of Nipple Discharge Identify the Location of the lesion Assist needle localization for non-palpable lesion in the ductal system Help to do the minimal invasive surgery

Ranfac Breast Marking System Ranfac 乳房定位針

The wire extends through a subtle area of distortion of the breast architecture.

台灣地區50-69歲婦女乳癌篩檢 Mammography(93.7– 98.10)

台灣地區50-69歲婦女乳癌篩檢 Mammography(93.7– 98.10) 認證醫院 50-69 婦女人口 實際乳房攝影 （實際/需求） 國健目標數 陽性個案 93年 102 2,022,451 18,397 （0.91％） 45,000 （未達到） 1,921 (10.44%) 94年 119 2,117,198 62,953 （2.97％） 30,000 （達到） 7,323 (11.63%) 95年 123 2,220,218 105,411 （4.75％） 85,000 10,286 (9.76%) 96年 2,310,669 132,604 （5.74％） 100,000 12,263 (9.25%) 97年 135 2,410,281 152,204 （6.31％） 120,000 14,961 (9.83%) 98年10月 138 2,390,957 217,557 （ 9.09％） 200,000 20,416 ( 9.38%)

Non-palpable lesion needle localization Needle Localization for Excisional Biopsy Lumpectomy Mammography or Ultrasound

Needle Localization for Excisional Biopsy When finding on FNA or CNB do not correlate with mammographic and clinical finding, a needle localization excisional biopsy is performed -current practice at M.D. Anderson

FNA vs. CNB vs. WNL (1) 影像導引細針抽吸 (image guide FNAB) 影像導引粗針切片 (image guide CNB) 細針定位外科切片手術 (needle localization surgical biopsy) 優 點 1.是一種最簡單、最不具侵 襲性也最便宜的方法 1.一般的病理科醫師 就能做正確的判讀 2.不具侵襲性，而其 準確率比 FNAB 還高 最準確的診斷方法 缺 1.需要有經驗的細胞學病理 專家 (cytopathologist) 才能做正確的判讀 2.有時因為抽到的細胞數量 太少，而判讀不易或完全無 法判讀 3.如果診斷為癌症，不但無 法知道是否為侵犯性癌 (invasive cancer)，也無 法判斷其級別 (grade) 組織切片取樣仍有限, 有些嚴重病灶仍有可 能錯失診斷 最具侵襲性,可能造成明 顯的疤痕 19 ～ 27 號細針頭 14 ～ 18 號粗針頭, 或更粗之針 20~21號針頭+ Hook Wire定位導線

FNA vs. CNB vs. WNL (2) 影像導引細針抽吸 (image guide FNAB) 影像導引粗針切片 (image guide CNB) 細針定位外科切片手術 (needle localization surgical biopsy) 導引 影像 超音波導引為主 乳房攝影or超音波導引 臨床 應用 良性病灶的確認 大多數之乳房病灶的切 片診斷 1.無法觸摸到的或較微小 病灶的外科切片 2.乳房腫瘤切除術術前定 位(經CNB確診,需手術切除) 健保 術碼 63010C 乳房腫瘤組織檢查切 片術 2801點 1. 33125C 乳房攝影立 體定位組織切片 3000點 2. 63010C 乳房腫瘤組 織檢查切片術 2801點 63011C 術前定位下乳房腫 瘤切除術，單側 4679點 切片針 或定位 針健保 給付 健保給付 750~991點 健保給付 680點 coaxial 1500點 新健保給付

Indication of Needle localization for Memorial Sloan-Kettering Cancer Center 1. 1057 nonpalpable breast lesions that had preoperative needle localization (Jan. 1999 to Jan. 2000) 2. Indications for needle localization: a. diagnosis, wide sampling of lesions yielding indeterminate results at percutaneous biopsy b. surgical treatment of percutaneously proven cancers. 3. Percutaneous biopsy was offered as an alternative to surgical biopsy for patients 4. The choice of percutaneous or surgical biopsy was made after consultations between the radiologist and referring physician and discussion with the patient

The lesion recommend exsional biopsy ◎ The papillomas with atypia ◎ Fibroadenoma have feature that suggest the possibility of phyllodes tumor ◎ Lesion can not be categorized with confidence as DCIS or LCIS after CNB ◎ Atypical lobular hyperlasia(ALH) and LCIS ◎ Other nonmalignant lesions with risk Practice at M.D. Anderson

Needle Localization for Lumpectomy surgical treatment of percutaneously proven cancers The wire-localized lumpectomy is similar to wire localized biopsy except the surgeon is attempting to obtain negative margin Localization & Bracketing (more than one wire) Wire place just posterior to the lesion are helpful

Needle Localization for Lumpectomy (1)

Needle Localization for Lumpectomy (2)

Needle Localization for Lumpectomy (2)

Ranfac’s Breast Marking System (1)

Position & re-position

Remove the needle

Ranfac’s Breast Marking System (2) Improved by Norman L. Sadowsky (Harvard Medical School) A cosmetically acceptable incision could be made The suspicious area may or may not become grossly apparent or palpable at the end of stiffening cannula depending on the size of lesion Provide different sizes of stiffening needle

Ranfac’s Breast Marking System (3) Stiffening needle 提供定位上的好處如下 提供可觸摸到的領針(stiffening cannula), 協助外科醫師執行手術 病患使用Mammography 定位術時, 由原先站姿(upright)改換成躺臥(Supine)時, stiffening cannula的操作 可提供定位上的參數 領針可協助外科醫師計劃做美容式切片手術(cosmetic acceptable incision) 對於東方女性較緊實緻密(dense)的組織,明顯的觸感更為重要 領針(stiffening cannula)對於教育訓練上的目地亦提供特別優勢 領針可避免wire 滑脫及位移,同時避免wire於術中被意外切斷

領針可避免wire滑脫及位移, 同時避免wire於術中被意外切斷

Ranfac Breast Marking System Specification SBS/ REL: with or without Stiffening needle

Ranfac Breast Marking System 健保給付 耗材: 2011年4月 給付生效

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