JP6152170B2 - 副鼻腔炎又はアレルギー性鼻炎治療用プロテーゼシステム - Google Patents
副鼻腔炎又はアレルギー性鼻炎治療用プロテーゼシステム Download PDFInfo
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- JP6152170B2 JP6152170B2 JP2015540999A JP2015540999A JP6152170B2 JP 6152170 B2 JP6152170 B2 JP 6152170B2 JP 2015540999 A JP2015540999 A JP 2015540999A JP 2015540999 A JP2015540999 A JP 2015540999A JP 6152170 B2 JP6152170 B2 JP 6152170B2
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- prosthesis
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- sinusitis
- allergic rhinitis
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Images
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- A—HUMAN NECESSITIES
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Landscapes
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Description
図1A及び1Bに示すように、本発明の一つの好ましい実施例による副鼻腔炎又はアレルギー性鼻炎治療用プロテーゼシステムは、モノフィラメントを編織してなるプロテーゼ10であり、当該モノフィラメントは、分解性ポリマーからなる。プロテーゼ10は、周方向に延びる壁面11を備え、壁面11は、周方向において閉じられ、つまり、当該壁面11により周方向に閉じられた空洞が区画され、当該空洞の両端が開放されている。壁面11は、モノフィラメントを編織してなり、モノフィラメントの間に所定の隙間が形成されている。したがって、壁面11は、ある程度の弾性を有し、適宜に圧縮及び拡張できる。
図2に示すように、本発明の又一つの好ましい実施例による副鼻腔炎又はアレルギー性鼻炎治療用プロテーゼシステムは、モノフィラメントから編織されてなる筒状のプロテーゼ20であり、モノフィラメントが分解性ポリマーからなる。プロテーゼ20は、周方向に延びる壁面21を有し、壁面21は、周方向に閉じられ、つまり、当該壁面21により周方向に閉じられた空洞が区画され、当該空洞の両端(両頭)が開放されている。即ち、プロテーゼ20は、筒状構造となる。壁面21は、モノフィラメントを編織してなり、モノフィラメントとモノフィラメントとの間に所定の隙間が介在する。そのため、壁面21は、ある程度の弾性を有し、適当に圧縮及び拡張できる。上記の実施例と同様に、編織の際に、プロテーゼ20の端部の後屈頂点22の数と、モノフィラメントを巻き付けるときのらせん角度とを調節することによって、プロテーゼの性能、例えば、移植前の加工可能性、移植時の搬送可能性及び移植後の治療効果などのバランスを取る。後屈頂点22の数が多ければ、プロテーゼのモノフィラメント交点23の数が多くなり、クリンプ時に受ける拘束が大きくなり、移植前にプロテーゼを小さい外径に加工しにくく、移植時の通過性(搬送可能性)が悪くなる一方、移植後の支持力が大きくなる。巻き付けるときのらせん角度が大きければ、編織が粗となり、プロテーゼのモノフィラメントの交点23の数が少ないため、クリンプ時に受ける拘束が小さく、移植前にプロテーゼを小さい外径に加工しやすく、移植時の通過性(搬送可能性)がよくなる一方、移植後の支持力が小さくなる。
図3A及び3Bに示すように、本発明の又一つの好ましい実施例による副鼻腔炎又はアレルギー性鼻炎治療用プロテーゼシステムは、筒状の基礎体30を含み、当該基礎体30の壁面31にはレーザ切断によって隙間32が形成されている。プロテーゼシステムは、さらに、フレア端部を備え、当該フレア端部は、モノフィラメントが隙間32に挿通されながら基礎体30の両端から軸方向に沿って外方へ編織されてなる。
図4に示すように、本発明の又一つの好ましい実施例による副鼻腔炎又はアレルギー性鼻炎治療用プロテーゼシステムは、筒状のプロテーゼ40である。プロテーゼ40は、周方向に延びる壁面41を有し、当該壁面41は、周方向に閉じられ、つまり、当該壁面21により周方向に閉じられた空洞が区画され、当該空洞の両端が開放されている。即ち、プロテーゼ40は、筒状の構造となる。壁面41は、分解性ポリマーからなる平板状の構造となり、レーザで壁面41の一部を切断することにより、当該壁面に径方向において外方へ突出する突起42を形成し、それに対応して、壁面に隙間43が形成される。本実施例において、レーザ切断により壁面41に三角形の2辺を形成し、当該三角形を未切断の辺に沿って曲げることで突起42が形成される。壁面41は、繊維の柔軟性及び隙間43の形成により、外力の作用を受けて圧縮及び拡張できる。当該突起42及びそれに対応する隙間43の形状、位置が、必要に応じて調整できることは、当業者によって理解されるだろう。プロテーゼ40は、自己膨張型プロテーゼシステムを示す。非膨張状態にあるときに、プロテーゼ40は円柱形を示し、直径が0.5−10mmであることが好ましい。膨張状態にあるときに、プロテーゼ40の径方向長さが2mm〜30mmで、軸方向長さが2mm−60mmである。プロテーゼがクリンプされると、突起がプロテーゼの表面に退避される。プロテーゼが解放されると、突起がバルーンからの支持力により押し出されて、プロテーゼの外表面から突出して、棘となる。このようなプロテーゼは、少なくとも一つの棘状物を含み、棘状物が鼻腔の表面皮層に突き刺されることによって、固定作用を発揮する。棘状物は、プロテーゼの中間位置のみに設けられてもよいが、球形又は楕円形のバルーンによりプロテーゼを拡張させる場合、棘状物が伸びやすいように、プロテーゼの中間部の直径が両端部の直径よりも大きい。
図5A及び5Bに示すように、本発明の又一つの好ましい実施例による副鼻腔炎又はアレルギー性鼻炎治療用プロテーゼシステムは、筒状のプロテーゼ50aである。図5Bに示すように、プロテーゼ50aは、周方向に延びる壁面51aを有し、当該壁面51aは周方向に閉じられ、即ち、壁面51aにより周方向が閉じられた空洞が区画され、当該空洞の両端が開放されている。即ち、プロテーゼ51aは、筒状の構造となる。図5A及び5Bに示すように、プロテーゼ壁面51aは、分解性ポリマーから管状の基礎体50を形成し、レーザ切断などの手段により基礎体50の壁面51に各種形状及び間隔の隙間55を形成することによって形成され、壁面51は、外力により圧縮及び拡張できる。壁面51aの両端52a、53aは、径方向において外方へ漸次に延出する位置決め部を有し、つまり、壁面の両端52a、53aの径方向長さが中間部54aの径方向長さよりも大きい。本実施例において、プロテーゼ50aの両端は、ラッパ状の開口を有する。位置決め部の形状、位置は、必要に応じて調整できる。プロテーゼ50aは、自己膨張型プロテーゼシステムを示す。非膨張状態にあるときに、プロテーゼ50aは円柱形を示し、直径が0.5−10mmであることが好ましい。膨張状態にあるときに、プロテーゼ50aの中間部54aの径方向長さが2mm〜30mmであり、プロテーゼ50aの両端部52a、53aの径方向長さが中間部54aの径方向長さよりも2mm〜30mm大きく、プロテーゼ50aの軸方向長さが2mm−60mmである。プロテーゼの形成において、ラッパ状のバルーンによりプロテーゼをクリンプして解放させることで、両端部がラッパ状となるプロテーゼが得られる。また、等径管材を切断してプロテーゼを形成し、両端の1/5〜1/3の長さをわざとやや大きい直径に設計し、中間をやや小さい直径に形成してもよい。その後に、ラッパ状のバルーンでプロテーゼをクリンプして解放させることにより、両端がラッパ状となるプロテーゼが得られる。また、分解性材料により分解性不織布又は平面網を編織することができ、溶接又は縫製により不織布又は編織網を直筒又はラッパ状のプロテーゼに成形してもよい。プロテーゼは、押圧膜、鋳造、編織、巻き付け、レーザ切断などの一つ又は複数の加工手段により得られる。
図6に示すように、本発明の又一つの好ましい実施例による副鼻腔炎又はアレルギー性鼻炎治療用プロテーゼシステムは、プロテーゼ60である。プロテーゼ60は、周方向に延びる壁面61を備え、壁面61は、周方向において閉じられておらず、C字状を示す。円周全体における壁面61の円弧部分の角度が60〜360度である。壁面61は、分解性ポリマーから平板状構造の壁面を形成した後に、レーザ切断加工により壁面において均一に分布された(もちろん、均一ではなくてもよい)アイレット62を形成し、分解性繊維63を前記アイレットに挿通させる。本実施例において、壁面61は、シート状基体を巻き付けてなるが、予めシート状の基体に対して切断加工を行うことによりアイレット62を形成してもよく、当該シート状の基体を巻き付けてから切断加工を行うことによりアイレット62を形成してもよい。壁面61は、ポリマー平板の柔軟性及びアイレット62により、外力の作用で圧縮及び拡張できる。一方、壁面61が周方向において閉じられていないため、壁面61の張力によりプロテーゼ60の圧縮性能及び拡張性能が向上する。プロテーゼが圧縮(クリンプ)されるときに、壁面61を巻き付けてから、分解性繊維63で結束することにより、プロテーゼをかなり小さい直径範囲に制限できる。アイレット62及び繊維63の形状、位置が必要に応じて調節できることは理解できるだろう。プロテーゼ60は、自己膨張型プロテーゼシステムを示し、解放前はカテーテルシース内に収容され、手術時に、医者よりカテーテル内から押し出されると、プロテーゼが膨張して拡張され、支持作用を発揮する。プロテーゼをバルーンに縛って、バルーンにより病変部位を拡張させてもよい。非膨張状態にあるときに、プロテーゼ60は円柱形を示し、直径が0.5−10mmであることが好ましい。膨張状態にあるときに、プロテーゼ60の径方向長さが2mm〜30mmであり、軸方向長さが2mm−60mmである。加工時に、プロテーゼは、ポリマー繊維を絞るとともに薄板を巻き付けることにより、支持物の直径を縮小させ、最後には、挿通された繊維でプロテーゼを縛って搬送システムに固定させる。移植後にプロテーゼが開放されると、自然に膨張される。このような薄板状の支持物の特徴は、支持力が強く、移植後の組織に対する付着効果がよいため、両端部が大きいデザインではなくても、病変部位の移植箇所に確実に留置できる。もちろん、挿通された繊維により、支持物と病変部位組織との摩擦力を向上でき、位置の固定に対しても貢献できる。
Claims (6)
- 周方向に延びるポリマー製の壁面を有する副鼻腔炎又はアレルギー性鼻炎治療用プロテーゼシステムであって、
前記壁面はモノフィラメント間に複数の隙間を備えたモノフィラメントの編織により形成されており、前記隙間に薬物含有の繊維糸束が挿通されており、
前記壁面は、周方向において閉じられているとともに、両端が開放されている筒状の構造であり、前記壁面の両端に、径方向に沿って外方へ漸次に延出する位置決め部を備えている、
ことを特徴とする副鼻腔炎又はアレルギー性鼻炎治療用プロテーゼシステム。 - 前記壁面は、筒状の基礎体と、モノフィラメントの編織により形成されたフレア端部とを含み、前記フレア端部は、基体の両端から軸方向に沿って外方へ編織されてなる、ことを特徴とする請求項1に記載の副鼻腔炎又はアレルギー性鼻炎治療用プロテーゼシステム。
- 前記壁面に薬物被覆層を備え、前記壁面の薬物被覆層における薬物は、前記繊維糸束に含有される薬物と同じであることを特徴とする請求項1に記載の副鼻腔炎又はアレルギー性鼻炎治療用プロテーゼシステム。
- 前記壁面に薬物被覆層を備え、前記壁面の薬物被覆層における薬物は、前記繊維糸束に含有される薬物とは異なることを特徴とする請求項1に記載の副鼻腔炎又はアレルギー性鼻炎治療用プロテーゼシステム。
- 前記壁面の外表面に、径方向に沿って外方へ延出する突起を少なくとも一つ備える、ことを特徴とする請求項1に記載の副鼻腔炎又はアレルギー性鼻炎治療用プロテーゼシステム。
- 前記壁面は、均一に分布されるアイレットと、前記アイレットを貫通する支持筋とを備える、
ことを特徴とする請求項2に記載の副鼻腔炎又はアレルギー性鼻炎治療用プロテーゼシステム。
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2012
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2013
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- 2013-09-23 US US14/401,266 patent/US20150100133A1/en not_active Abandoned
- 2013-09-23 EP EP13854782.3A patent/EP2921138B1/en active Active
- 2013-09-23 JP JP2015540999A patent/JP6152170B2/ja not_active Expired - Fee Related
- 2013-09-23 WO PCT/CN2013/083986 patent/WO2014075514A1/zh active Application Filing
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WO2014075514A1 (zh) | 2014-05-22 |
BR112014028185A2 (pt) | 2017-06-27 |
CN102988122A (zh) | 2013-03-27 |
JP2015533589A (ja) | 2015-11-26 |
US20150100133A1 (en) | 2015-04-09 |
CN102988122B (zh) | 2013-11-06 |
EP2921138A1 (en) | 2015-09-23 |
EP2921138A4 (en) | 2015-11-04 |
EP2921138B1 (en) | 2022-11-09 |
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