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ORGAN RESECTION STUMP FIXING CLIP meetings

Foreign code F200010247
File No. (S2019-0246-N0)
Posted date Oct 30, 2020
Country WIPO
International application number 2020JP011641
International publication number WO2020189666
Date of international filing Mar 17, 2020
Date of international publication Sep 24, 2020
Priority data
  • P2019-050488 (Mar 18, 2019) JP
Title ORGAN RESECTION STUMP FIXING CLIP meetings
Abstract The purpose of the present invention is to provide a means for fixing a pancreas resection stump that is generated during surgery in which a portion of the pancreas is resected. The present invention provides a polymer surgical clip that comprises a first arm part, a second arm part, and an elastic hinge part that connects the first and second arm parts. The polymer surgical clip is characterized in that base parts of the arm parts are connected to the elastic hinge part, in that the first arm part has a protruding outside surface and a recessed inside surface that is to clamp the pancreas, in that the second arm part has a protruding or flat outside surface and a recessed or flat inside surface that is to clamp the pancreas, in that a flexible hook part that curves toward the second arm part is formed at the tip of the first arm part, and in that, in a closed position, the tip of the second arm part enters and engages the curved hook part, locking the clip in the closed position.
Outline of related art and contending technology BACKGROUND ART
Pancreatic juice fistula occurring after pancreas excision is a phenomenon in which pancreatic juice leaks continuously or intermittently. Although pancreatic tail excision has been performed as a root treatment of pancreatic tail tumor, pancreatic juice fistula in which pancreatic juice (digestive enzyme) leaks from pancreatic stumps after pancreatic tail excision may occur, which is one of the complications that have not been solved yet. Pancreatic fluid fistula sometimes melts), such as the surrounding tissue (artery, causing major bleeding and becoming lethal. Postoperative pancreatic juice fistula occurs at about 30 % of pancreatic tail resection, which also causes life-threatening complications.
In pancreatic tail resection, the main pancreatic duct was ligated and the pancreatic parenchyma on the side of the head was closed to prevent the leakage of pancreatic juice.
Various techniques have been used to close pancreatic parenchyma on the side of the resected pancreatic head in pancreatic tail resection. Stapling, liver circle-patching method (teres ligament patching), puck method, TachoSil (Registered trademark) patching method, and pancreatic duct, jejunum (pancreatic duct, stomach) anastomosis, although which technique is suitable is discussed. With the increase of laparoscopic pancreatic tail resection, the closure of resected stumps by staplers has become more common in recent years.
In this paper, we propose a new stapler for pancreatic parenchyma separation. in this paper, we propose a new stapler for pancreatic parenchyma separation. Therefore, we reported that grade B or C pancreatic juice fistula is significantly reduced compared to normal staplers using a set of (Non-Patent Document 1: Yamashita et al . , Anticancer Res. 37: 1865-1868 , 2017). In this report, it is reported that the error 30 % in the case of using the normal stapler is 5 % in the case of using the set.
On the other hand, clips have been proposed for ligating blood vessels during surgery to stop blood flow. For example, it is composed of 1 th and 2 th curved leg members, both leg members being joined at their close ends by elastic hinge means, the 1 th leg member being a flexible hook part curved toward the 2 th leg member at its end, On the other hand, the end of the 2 th leg member serves as a lock portion complementarily to the hook portion, and a polymer surgical clip is proposed. Here, the blood vessel clamping inner surface of the 1 th leg member and the blood vessel clamping inner surface of the 2 th leg member face each other, and the radius of curvature of the inner concave surface of the 1 th leg member and the radius of curvature of the inner convex surface of the 2 th leg member are substantially the same. For this reason, as shown in Fig. 7 E, the vessel clamping inner surfaces of the leg members overlap each other from the proximal end to the distal end thereof.
And a 1 th and 2 th curves connected by resilient hinge means, each having a vessel clamping inner surface such that one vessel clamping inner surface faces the other vessel clamping inner surface, A polymer surgical clip in which each blood vessel clamping inner surface has a plurality of projections is proposed. Wherein the radius of curvature of the inner concave surface for vessel clamping of the 1 th curve set and the radius of curvature of the inner convex surface for vessel clamping of the 2 th curve set are substantially the same, As shown in Fig. 12 E, the respective vessel clamping inner surfaces overlap each other from the proximal end (hinge means proximal portion) to the distal end of both curves.
Furthermore, a surgical clip including an upper jaw member and a lower jaw member that are joined together at a hinge section for movement about the hinge section has been proposed. Here, the maxillary member and mandibular member each include an inner convex section in a portion of the hinge section and are configured to pinch a proximal portion of tissue. The maxillary member has a generally convex outer surface and a S-shaped inner surface, and the mandibular member has a generally concave outer surface and a S-shaped inner surface that substantially matches or conforms to the profile of the inner surface of the maxillary member. Thus, as shown in Fig.4, the clamping inner surfaces of the jaws are configured to overlap each other from the hinged section to the distal end of the jaws.
In addition, a movement prevention surgical ligation clip for ligation of blood vessels or tissue structures has been proposed. There is provided a 1 th leg member including a 1 th inner surface and a plurality of 1 th protrusions disposed on the 1 th inner surface, a 2 th leg member including a 2 th inner surface and a plurality of 2 th protrusions disposed on the 2 th inner surface, and a hinge member joining the 1 th leg member and the 2 th leg member, A surgical clip for ligating a blood vessel or tissue structure is disclosed, wherein at least one of a plurality of 1 th projections and a plurality of 2 th projections includes a gable structure extending along a longitudinal direction of the 1 th inner surface or 2 th inner surface. As shown in Fig. 3 A, the inner surfaces disposed on the respective leg members overlap each other.
Also, as a clip for ligating blood vessels, a polymer Hem-o-lok (Registered trademark) is sold by Teleflex Company, where the Hem-o-lok (Registered trademark) is composed of 1 th and 2 th curved leg members curved in the same direction, Both leg members are joined at their close ends by an elastic hinge, and the end of the 1 th leg member is a flexible hook part curved toward the 2 th leg member, while the end of the 2 th leg member is a locking part complementarily to the hook part. Here, the blood vessel clamping inner surface of the 1 th leg member and the blood vessel clamping inner surface of the 2 th leg member face each other, and the radius of curvature of the inner concave surface of the 1 th leg member and the radius of curvature of the inner convex surface of the 2 th leg member are substantially the same. Therefore, the vessel clamping inner surfaces are configured to overlap each other from the proximal end to the distal end of both leg members (https:/ / www.teleflex. com / usa / en / product-areas / surgical / ligation-solutions / weck-polymer-ligation /).
In addition, (U.S. Patent No.6699258 is proposed a ligation clip comprising an upper jaw, a lower jaw and a hinge portion connecting the upper jaw and the lower jaw made of metal. There is provided a metal upper jaw comprising stress relief means (stress relief mechanism) and curved outwardly; Disclosed is a clip comprising a metal mandible including a latch portion at a 1 th distal end configured to engage a distal end of the maxilla when a curved portion of the maxilla is extended, and a hinge portion at a 2 th distal end opposite the 1 th distal end. In the clip, as shown in Fig.3, when the blood vessel is closed, the curved portion of the upper jaw is extended to be straight and permanently deformed, and the distal end of the upper jaw is engaged with the latch portion of the lower jaw. That is, the engagement is achieved by permanently extending the curved portion made of metal.
Also, as clips for appendectomy, AESCULAP (Registered trademark) DS clips are marketed by Shelper Co., Ltd., Parallel closure is achieved by permanently extending the upper and lower jaws of curved metal (https:/ / www.bbraun.jp / ja / products / b / ds-titanium-ligationclips.html).
Scope of claims (In Japanese)[請求項1]
 第1腕部、第2腕部、及び第1及び第2腕部を連結する弾性ヒンジ部からなり、第1及び第2の両腕部は各々の基部において前記弾性ヒンジ部と連結されており、第1腕部は、凸状の外側面と膵臓をクランプする凹状の内側面とを有し、第2腕部は、凸状又は平面状の外側面と膵臓をクランプする凹状又は平面状の内側面とを有し、第1腕部の内側面と第2腕部の内側面は互いに向かい合いあっており、第1腕部はその先端が第2腕部の方へ湾曲した屈撓性フック部を形成し、これによって、閉鎖位置において第2腕部の先端が上記湾曲したフック部の内側へと入り込みフック部と係合してクリップを閉鎖位置にロックするように構成されている膵臓切除術用のポリマー製手術用クリップであって、
第1腕部と第2腕部は、開放位置及び閉鎖位置において略同一の形状を維持し、膵臓をクランプする第1腕部の内側面と第2腕部の内側面は、両内側面の間に空間が生じるように構成されていることを特徴とするポリマー製手術用クリップ。

[請求項2]
 第2腕部は、凸状の外側面と膵臓をクランプする凹状の内側面とを有し、第1腕部の内側面と第2腕部の内側面は互いに向かい合いあって相反する曲面を構成していることを特徴とする請求項1に記載のポリマー製手術用クリップ。

[請求項3]
 閉鎖位置において第1腕部の内側面と第2腕部の内側面の間に生じる最大距離が、第1腕部又は第2腕部の内側面と外側面間の厚みのいずれかよりも大きいことを特徴とする請求項1又は2に記載のポリマー製手術用クリップ。

[請求項4]
 第1腕部の内側面と外側面間の厚みが、第2腕部の内側面と外側面間の厚みと実質的に同じである請求項1~3のいずれか一つに記載のポリマー製手術用クリップ。

[請求項5]
 第1腕部の凹状の内側面の曲率半径が、第2腕部の凹状の内側面の曲率半径と実質的に等しい請求項1~4のいずれか一つに記載のポリマー製手術用クリップ。

[請求項6]
 第1腕部及び第2腕部はそれぞれ、側方に延在する1又は2つの突起部を有する、請求項1~5のいずれか一つに記載のポリマー製手術用クリップ。

[請求項7]
 らに、第1腕部の基部付近の内側面及び第2腕部の基部付近の内側面に、それぞれこぶ部を有する、請求項1~6のいずれか一つに記載のポリマー製手術用クリップ。

[請求項8]
第1腕部の内側面及び/又は第2腕部の内側面は、凹凸と有する面または複数の突起を備えた面である、請求項1~7のいずれか一つに記載のポリマー製手術用クリップ。

[請求項9]
閉鎖位置におけるクリップ全体の形状にて形状記憶されている請求項1~8のいずれか一つに記載のポリマー製手術用クリップ。

[請求項10]
生体吸収性ポリマーからなる請求項1~9のいずれか一つに記載のポリマー製手術用クリップ。

[請求項11]
 膵切除術により切除された膵臓の切離部断端の固定のために用いられることを特徴とする請求項1~10のいずれか一つに記載のポリマー製手術用クリップ。

[請求項12]
膵臓の切離部断端を固定した際に少なくとも4kPa以上の圧力にて膵臓をクランプするように構成されている、請求項11に記載のポリマー製手術用クリップ。

[請求項13]
 膵体尾部切除術、膵頭十二指腸切除術、膵臓の腫瘍核出術、及び膵中央切除術からなる群から選ばれる手術方法に用いられることを特徴とする請求項1~12のいずれか一つに記載のポリマー製手術用クリップ。
  • Applicant
  • ※All designated countries except for US in the data before July 2012
  • KUMAMOTO UNIVERSITY
  • KYUSHU UNIVERSITY
  • Inventor
  • BABA Hideo
  • YAMASHITA Yoichi
  • IJIMA Hiroyuki
IPC(International Patent Classification)
Specified countries National States: AE AG AL AM AO AT AU AZ BA BB BG BH BN BR BW BY BZ CA CH CL CN CO CR CU CZ DE DJ DK DM DO DZ EC EE EG ES FI GB GD GE GH GM GT HN HR HU ID IL IN IR IS JO JP KE KG KH KN KP KR KW KZ LA LC LK LR LS LU LY MA MD ME MG MK MN MW MX MY MZ NA NG NI NO NZ OM PA PE PG PH PL PT QA RO RS RU RW SA SC SD SE SG SK SL ST SV SY TH TJ TM TN TR TT TZ UA UG US UZ VC VN WS ZA ZM ZW
ARIPO: BW GH GM KE LR LS MW MZ NA RW SD SL SZ TZ UG ZM ZW
EAPO: AM AZ BY KG KZ RU TJ TM
EPO: AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
OAPI: BF BJ CF CG CI CM GA GN GQ GW KM ML MR NE SN ST TD TG
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