- 學位論文
腹腔鏡組織凝集刀和超音波刀之專利分析，市場研究和文獻回顧
Patent Analysis, Market Research, and Literatures Review of Laparoscopic Vessel Sealing System
摘要
腹腔鏡手術(微創手術)中因為視野觀係，止血一直是很重要的議題。近年來發展出以能 量來止血，並直接血管結紮的儀器。最初設計是為了取代金屬夾子，自動吻合器，或腹 腔鏡用打結器。 一種是基於超聲波的壓電效應，轉換高頻振動至工具的最前端，造成附近的蛋白質 產生機械變性以閉合及切割血管。這一類醫療儀器的演變從55.5 千赫頻率的縱向振動， 到現在巳有36 千赫頻率做橫向扭轉的器械問世。對所欲閉合的血管組織影響，其閉合 後血管管腔內所能承受之平均最大爆破壓力為226-921 毫米汞柱，封合所須時間為 2.3-4.0 秒，密封寬度(針對2 到5 毫米直徑的中小型動脈)為0.1 -2.4 毫米。這一類的 腹腔鏡手術儀器有Harmonic Scalpel®、SonoSurg、AutoSonixTM、LOTUS®。 另一型是以雙極電燒為基礎原理的手術儀器。它通常是以間斷的高壓電流來對血管 組織做燒灼凝固。典型的週期是6%高壓通電時間，之後關閉94％時間。它的關鍵點是 以反饋控制系統來感測燒灼血管組織的阻抗變化，然後調整其輸出的電壓和電流，以保 持適當的功率輸出。傳統類比集成電路可達到每秒200 次感測及調整。新型則使用 Goertzel 演算法的數位訊號處理器。因為組織燒灼後的阻抗變化會導致電壓和電流之變 動，Goertzel 演算法是計算其電壓和電流(頻率領域)相位角差，如此對感測、調整可飆 高到每秒4000 次。同上，其平均最大爆破壓力、封合時間、血管密封寬度(針對6 到7 毫米直徑的血管）分別是284.5-842 毫米汞柱， 3.54-8.25 秒， 1.8-2.5 毫米。這一 類的腹腔鏡手術儀器有LigaSureTM、EnSeal®、LIGATOR®、LAP BiClamp®、PKS™ Cutting Forceps & Gyrus 和Plasma Trissector™、SealSafeTM 和 EndoSealTM。 如果從專利分析的角度來看這兩種儀器的發展。Harmonic Scalpel®的專利被引用率、 技術獨立指標、科學相關指標分別是15.25、3.47 及0.09。LigaSureTM 則分別是21.86、 12.94 及12.58。兩者引用率在機工領域都屬較高的；但LigaSureTM 則有較高的科學文 獻相關性。從技術生命週期來看，兩者皆陷入技術研發瓶頸。以專利件數做Pearl Curve 產業分析，這兩種儀器巳達技術成熟。 II 如從市場研究而言。整個直接能量止血的腹腔鏡手術儀器的市場中，Harmonic Scalpel® 是最早出現在市場上的。它在1991 年上市，屬Ultracision 公司的產品。之後併入 Ethicon Endo-Surgery 公司，也順理成章成為Johnson & Johnson 公司旗下產品。 LigaSureTM 的早期專利是由Sherwood 公司研發，但遲到1998 年方由Valleylab 公司上 市。在經過Tyco 商業合併之後，現屬Covidien 公司旗下。 Harmonic Scalpel®原本壟斷整個市場，但LigaSureTM 在2005-2006 年推出新的型 號AdvanceTM系列及新的主機ForceTriadTM後急起直追。這也迫使新機型的Harmonic ACE® 推出。目前市場佔有率LigaSureTM 佔32%，Harmonic Scalpel®則萎縮到57%。目前這兩 種儀器的市場佔有率超出八成。其它廠商仍難望其項背。
並列摘要
Hemostasis is an important session in laparoscopic surgery. Traditionally, clip and autosuture were used for vessel ligation. The direct-energy vessel-sealing system provides another way. Among them, Harmonic Scalpel® and LigaSureTM are two leaders. They are initially design for replace the metal clip, autosuture, or intracorporeal knot tying. Harmonic Scalpel® is ultrasonic-based technique; and LigaSureTM is electronic-based device. The ultrasonic technology is based on the piezoelectric transduction of high-frequency vibrations of the instrument functional tip. It causes mechanical protein denaturation. Evolution is from the 55.5 kHz longitudinal vibration, to torsional mode with 36 kHz frequency. The mean bursting pressure, seal time, and sealing width of the sealed artery (2-5mm) is around 226-921 mmHg, 2.3-4.0 second, 0.1-2.4mm. The electrosurgical vessel sealing system is based on the bipolar application. For coagulation, the current is on typically 6% of the time period with high voltage, and off 94% off. The feedback control system stands the key point. It recognizes resistance (ohms) changes of tissue, and adjusts voltage and current to maintain appropriate power output. Evolution is from analog IC, to DSP using Goertzel Algorithm. The calculation of (frequently domain) phase angle difference, between the voltage and current, is jump from 200 times to 4000 times per second. The mean burst pressure, seal time, and sealing width for vessel diameter 6-7mm is 284.5-842 mmHg, 3.54-8.25 seconds, 1.8-2.5 mm. Most jaws are Reddick-Olsen or Maryland style. The surface topography optimum ranged 0.001 to 0.006 inches. Separating the thermal and electrically conductive plate, configured electrically conductive surface with non-conductive porous ceramic, or coating insulating substrate around electrically conductive plate, may decrease escher formation and flashover. It also decreases the clamp tissue damage force from 37 to 15N and slip force from 22N to 3N. The handle usually offer a ratchet for lock-in, one or more control button, and swivel knob for rotate the probe direction. The handle diameter, pivot are 4.8 to 5.7cm, 8.1 to 17.3 IV degrees. The trackball or button is located at the left of the center line of the long. The ratchet is located at the right. Form the patent analysis, the citation index, technology independent index, and scientific index are 15.25, 3.47, and 0.09 respectively for Harmonic Scalpel® . It is 21.86, 12.94, and 12.58 respectively for LigaSureTM. Both demonstrated high citation index among engineering filed, but LigaSureTM showed high relationship with science paper or conference. From the technology life cycle perspective, both are sink in the development peel. And from the industry analysis, those instruments are technologically mature. From the market research, the Harmonic Scalpel® was firstly marketed by Ultracision Inc. in 1991, which was later merged to Ethicon Endo-Surgery, Inc. and became a subdivision of Johnson & Johnson Inc.. Most of the LigasSureTM patents were developed by Sherwood AG,. However, it was marketed by Valleylab, Inc. initially in 1998. The company was merged to Tyco Ltd. later, and now under the Covidien Ltd. The other hemostasis device, based on ultrasonic, were SonoSurg (Olympus Co.)、 AutoSonixTM (Misonix Inc.)、LOTUS® (S.R.A. Development Ltd.). And there were other electrosurgical vessel sealing equipment like EnSeal® (SurgRx Inc.)、LIGATOR® (BOWA-electronic GmbH)、LAP BiClamp® (ERBE Elektromedizin GmbH)、PKS™ Cutting Forceps & Gyrus and Plasma Trissector™ (Gyrus ACMI Inc.)、SealSafeTM and EndoSealTM (Carl Martin GmbH). Harmonic Scalpel® monopolized this market initially, even LigaSure promoted it’s first generation. During 2005 and 2006, Valleylab introduced new design of LigaSure AdvanceTM and ForceTriadTM generator. Valleylab successful earn more market share, and it also push Ethicon Endo-Surgery to develop Harmonic ACE® . Market share of past two years show 32% by LigaSure™, and 57% by Harmonic Scalpel® . Both instruments, and as their companies, take more than 80% of the market.