JP2014133065A - Vascular occlusion device - Google Patents
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- JP2014133065A JP2014133065A JP2013004142A JP2013004142A JP2014133065A JP 2014133065 A JP2014133065 A JP 2014133065A JP 2013004142 A JP2013004142 A JP 2013004142A JP 2013004142 A JP2013004142 A JP 2013004142A JP 2014133065 A JP2014133065 A JP 2014133065A
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Abstract
Description
本発明は、目的部位の血管を内側から閉塞して血流を一時的に遮断するための血管閉塞器具に関する。 The present invention relates to a vascular occlusion device for occluding a blood vessel at a target site from the inside to temporarily block blood flow.
血液の流れや血管異常を治療したり、内臓の手術をしたりする際に特定部位の血管の血流を一時的に遮断しておく血流遮断施術が行われる。一時的に血流を遮断しておく代表的方法としてバルーンカテーテルを用いる方法がある。バルーンカテーテルは、カテーテルチューブとその先端部に取り付けた拡張可能なバルーンからなる。カテーテルチューブの多くは、外側チューブとその内部に配置される内側チューブとの二重構造になっている（例えば、特許文献１、２参照）。バルーンはシリコーンゴム、ラテックス等で製作され外側チューブの先端部に熱融着で取り付けられる。内側チューブは、ガイドワイヤを挿通させるとともにバルーンを膨らませる生理食塩水の注入経路としても使用される。 When a blood flow or vascular abnormality is treated or when a visceral operation is performed, a blood flow blocking operation is performed in which blood flow in a blood vessel at a specific site is temporarily blocked. As a typical method for temporarily blocking the blood flow, there is a method using a balloon catheter. A balloon catheter consists of a catheter tube and an expandable balloon attached to its distal end. Many catheter tubes have a double structure of an outer tube and an inner tube disposed therein (see, for example, Patent Documents 1 and 2). The balloon is made of silicone rubber, latex or the like and attached to the tip of the outer tube by heat sealing. The inner tube is also used as a saline injection path for inserting the guide wire and inflating the balloon.
生理食塩水の注入で膨らませたバルーンは血管を塞いで血流を遮断する。バルーンカテーテルは一時的な血流遮断の他に、血管等の体腔内の狭窄部で拡張させて狭窄部を拡張させる施術にも使用される。しかし、前述したような構成のバルーンカテーテルは、カテーテルチューブが二重構造、場合によっては三重構造になっているためチューブが太く、細い血管、尿管等にはスムーズに挿入できない問題がある。 A balloon inflated with saline injection blocks blood vessels and blocks blood flow. In addition to temporarily blocking blood flow, the balloon catheter is used for a procedure for expanding a stenosis by expanding the stenosis in a body cavity such as a blood vessel. However, the balloon catheter configured as described above has a problem that the catheter tube has a double structure, and in some cases has a triple structure, so that the tube is thick and cannot be smoothly inserted into a thin blood vessel, ureter or the like.
バルーンの拡張を生理食塩水の注入で行なうのでなく、バルーンの壁内又はバルーン内にスプライン状に変形可能な複数の金属細線からなる電極を配設し、その形状を変化させてバルーンを収縮膨張させる方式のバルーンカテーテルも開示されている（特許文献３、４参照）。この方式の場合、カテーテルシャフトは互いにスライド可能な外筒シャフトと内筒シャフトとから構成され、収縮膨張可能なバルーンが外筒シャフトの先端部と内筒シャフトの先端部近傍との間に取り付けてある。外筒シャフトと内筒シャフトとを互いにスライドさせるとスプラインの形状が変化し、被覆されたバルーンの形状が変化する。スライド量を調整してバルーンを膨張させると血管を塞いて血流が遮断される。しかし、この方式の場合も、カテーテルシャフト部が互いにスライド可能な外筒シャフトと内筒シャフトとで構成されるためシャフトが太くなって細い血管、尿管等にはスムーズに挿入できない問題がある。 Rather than performing balloon expansion by injecting physiological saline, an electrode made of a plurality of fine metal wires that can be deformed in a spline shape is placed in the balloon wall or inside the balloon, and the balloon is contracted and expanded by changing its shape. A balloon catheter of the type to be used is also disclosed (see Patent Documents 3 and 4). In this system, the catheter shaft is composed of an outer cylinder shaft and an inner cylinder shaft that are slidable with each other, and a balloon that can be contracted and inflated is attached between the tip of the outer cylinder shaft and the vicinity of the tip of the inner cylinder shaft. is there. When the outer cylinder shaft and the inner cylinder shaft are slid relative to each other, the shape of the spline changes and the shape of the covered balloon changes. When the balloon is inflated by adjusting the slide amount, the blood flow is blocked and the blood flow is blocked. However, even in this method, there is a problem that the catheter shaft portion is composed of an outer cylinder shaft and an inner cylinder shaft that are slidable with each other, so that the shaft becomes thick and cannot be smoothly inserted into thin blood vessels, ureters, and the like.
本発明は、従来技術のこうした問題点を解決するためになされたもので、その課題は、血管内に挿入して目的部位の血流を一時的に遮断するための外径が細く、簡単構造で操作が容易な血管閉塞器具を提供することにある。 The present invention has been made in order to solve such problems of the prior art, and the problem is that the outer diameter for inserting into a blood vessel and temporarily blocking the blood flow at a target site is thin, and has a simple structure. An object of the present invention is to provide a vascular occlusion device that is easy to operate.
前記課題を解決するための請求項１に記載の発明は、血管内に挿入して目的部位の血流を一時的に遮断するための血管閉塞器具であって、血管内に挿入する可とう性のカテーテルチューブと、該カテーテルチューブに挿通するワイヤと、該ワイヤの先端に取り付けたバルーン形成部とから構成され、バルーン形成部は弾性を有する４〜８本の弓状鋼線を周方向に等間隔に配して全体として略タマネギ形状に形成し、該タマネギ形状部の表面には前記ワイヤの反対側一部を除く表面を覆うバルーンを形成し、各弓状鋼線の一方の端部はまとめてワイヤの先端に固着し、他方の端部は棒状又はコイル状に撚り合わせて互いに固着してあることを特徴とする血管閉塞器具である。 The invention according to claim 1 for solving the above-mentioned problem is a vascular occlusion device for temporarily blocking blood flow at a target site by being inserted into a blood vessel, and is flexible to be inserted into the blood vessel. Catheter tube, a wire inserted into the catheter tube, and a balloon forming portion attached to the tip of the wire, and the balloon forming portion is composed of 4 to 8 arcuate steel wires having elasticity in the circumferential direction, etc. A generally onion shape is formed at intervals, and a balloon is formed on the surface of the onion-shaped portion so as to cover the surface excluding a part on the opposite side of the wire, and one end of each arcuate steel wire is The vascular occlusion device is characterized in that it is fixed together at the tip of the wire and the other end is twisted into a rod shape or a coil shape and fixed together.
このような構成の血管閉塞器具は、バルーンの拡径、膨張を弓状鋼線の弾性力のみで行なうため構造が簡単で操作も容易である。また、カテーテルチューブ内にはバルーン形成部とワイヤしか挿入されないため、従来のカテーテルに比べてその径を細くできる利点を有する。 The blood vessel occlusion device having such a configuration is simple in structure and easy to operate because the balloon is expanded and expanded only by the elastic force of the arcuate steel wire. Further, since only the balloon forming portion and the wire are inserted into the catheter tube, there is an advantage that the diameter can be reduced as compared with the conventional catheter.
また、請求項２に記載の発明は、請求項１に記載の血管閉塞器具において、バルーンはバルーンの膜内に弓状鋼線を包み込むように形成され、バルーン形成部がカテーテルチューブ内にあるときにはバルーンは折り畳まれた状態となるように取り付けてあることを特徴とする血管閉塞器具である。 The invention according to claim 2 is the vascular occlusion device according to claim 1, wherein the balloon is formed so as to wrap the arcuate steel wire in the balloon membrane, and the balloon forming part is in the catheter tube. The balloon is a vascular occlusion device that is attached so as to be folded.
このような構成とすれば、バルーンが弓状鋼線から外れることが効果的に防止される。 Such a configuration effectively prevents the balloon from coming off the arcuate steel wire.
交通事故などによる外傷では内臓破裂や骨盤骨折等で大量に出血することがある。こうした外傷性の出血に対する治療ではいち早く止血することが求められる。また、各種内蔵手術に際しては特定部位の血管の血流を止めることが求められる。本発明の血管閉塞器具は、こうした場合にカテーテル先端に取り付けたバルーンを血管内で膨張させることにより血管を閉塞して血流を一時的に遮断することを目的とするものである。 Injuries caused by traffic accidents may cause bleeding due to visceral rupture or pelvic fracture. Treatment for such traumatic bleeding requires immediate hemostasis. In addition, it is required to stop blood flow in a specific region during various internal surgeries. The vascular occlusion device of the present invention is intended to temporarily block the blood flow by occluding the blood vessel by inflating a balloon attached to the distal end of the catheter in the blood vessel in such a case.
以下、本発明に係る血管閉塞器具の一実施形態について図面を参照して説明する。本発明に係る血管閉塞器具１は、図１に示すようにバルーン形成部５とワイヤ４とカテーテルチューブ３により構成される。バルーン形成部５はワイヤ４の先端に取り付けられており、カテーテルチューブ３はワイヤ４先端のバルーン形成部５を血管内の目的位置に誘導するための細いチューブである。カテーテルチューブ３はポリエチレン、ポリイミド、ポリアミドイミド、ポリエチレンテレフタレート等の可とう性を有する熱可塑性ポリマーで製作する。 Hereinafter, an embodiment of a vascular occlusion device according to the present invention will be described with reference to the drawings. A vascular occlusion device 1 according to the present invention includes a balloon forming portion 5, a wire 4, and a catheter tube 3, as shown in FIG. The balloon forming part 5 is attached to the tip of the wire 4, and the catheter tube 3 is a thin tube for guiding the balloon forming part 5 at the tip of the wire 4 to a target position in the blood vessel. The catheter tube 3 is made of a thermoplastic polymer having flexibility such as polyethylene, polyimide, polyamideimide, polyethylene terephthalate.
バルーン形成部５を血管内の目的位置にまで押し込むためのワイヤ４はステンレス鋼やニッケルチタン合金の金属細線で、直径は０．３〜１．０ｍｍである。ワイヤ４の外周面にはカテーテルチューブ３の内壁との接触による摩擦を軽減するための皮膜を設けてもよい。皮膜の形成にはセルロース系高分子物質、ポリエチレンオキサイド系高分子物質等の親水性材料、フッ素系樹脂、シリコーン系樹脂等の疎水性材料を用いる。 The wire 4 for pushing the balloon forming part 5 to the target position in the blood vessel is a fine metal wire of stainless steel or nickel titanium alloy, and has a diameter of 0.3 to 1.0 mm. A coating for reducing friction caused by contact with the inner wall of the catheter tube 3 may be provided on the outer peripheral surface of the wire 4. For the formation of the film, a hydrophilic material such as a cellulose polymer material or a polyethylene oxide polymer material, or a hydrophobic material such as a fluorine resin or a silicone resin is used.
バルーン形成部５は、弾性を有する４〜８本の弓状鋼線６により略タマネギ形状の骨組を形成し、その表面にバルーン７を形成したものである。タマネギ形状骨組８のワイヤ４側は、弓状鋼線６を束ねた状態でワイヤ４の先端端面に突き合わせ抵抗溶接で固着してある。タマネギ形状骨組８の反対側は、弓状鋼線６を棒状又はコイル状に束ねた状態にして溶接で固着させてある。溶接の代わりに半田（ろう材）を用いて固めてもよい。棒状に束ねた先端部は丸みを帯びた形状にしておく。 The balloon forming portion 5 is formed by forming a substantially onion-shaped frame with 4 to 8 arcuate steel wires 6 having elasticity, and forming a balloon 7 on the surface thereof. The wire 4 side of the onion-shaped frame 8 is fixed to the tip end face of the wire 4 by butt resistance welding in a state where the arcuate steel wire 6 is bundled. The opposite side of the onion-shaped frame 8 is fixed by welding in a state where the arcuate steel wire 6 is bundled in a rod shape or a coil shape. Hardening may be performed using solder (brazing material) instead of welding. The tip part bundled in a rod shape is rounded.
タマネギ形状骨組８の表面部にはバルーン７が形成してある。図２はバルーン形成部５を最大径部で切断した端面図である。バルーン７は、タマネギ形状骨組８を形成している弓状鋼線６をその膜内に包み込むようにして形成してある。このようなバルーン７は、タマネギ形状骨組８をバルーン膜となる材料の溶液に浸漬して引き上げ、弓状鋼線６からなる骨組間に表面張力でシャボン玉のように形成された溶液膜を乾燥させるディッピング成形法で形成する。バルーン７の材料としてはポリウレタン、ポリアミド、ポリオレフィン、ポリエステル、シリコーンゴム等を用いる。バルーン７はタマネギ形状骨組８の全表面を覆うのでなく、乾燥によりバルーン膜を形成させた後に先端側の一部９を切り取って骨組内部と外部がつながるようにしてある。これは弓状鋼線６が血管内で弓状に変形してタマネギ形状を形成する際に内部に血液が入るようにするためである。 A balloon 7 is formed on the surface of the onion-shaped frame 8. FIG. 2 is an end view of the balloon forming portion 5 cut at the maximum diameter portion. The balloon 7 is formed so as to wrap the arcuate steel wire 6 forming the onion-shaped frame 8 in its membrane. In such a balloon 7, the onion-shaped frame 8 is dipped in a solution of the material that forms the balloon film and pulled up, and the solution film formed like a soap bubble is dried between the frames formed of the arcuate steel wire 6 by surface tension. The dipping method is used. As the material of the balloon 7, polyurethane, polyamide, polyolefin, polyester, silicone rubber or the like is used. The balloon 7 does not cover the entire surface of the onion-shaped frame 8, but after the balloon membrane is formed by drying, a part 9 on the distal end side is cut out so that the inside and outside of the frame are connected. This is because blood enters the arcuate steel wire 6 when the arcuate steel wire 6 is deformed into an arcuate shape in the blood vessel to form an onion shape.
図３はワイヤ４をカテーテルチューブ３に挿通させ、先端のバルーン形成部５をカテーテルチューブ３の先端から突出させた状態の外観図である。タマネギ形状をしたバルーン形成部５の最大径部は５〜３０ｍｍφで、カテーテルチューブ３の内径より大きい。このためバルーン形成部５の弓状鋼線６は、カテーテルチューブ３内を通過する際には図４に示すように弾性によりほぼ直線状に変形し、縮径したタマネギ形状がカテーテルチューブ３内壁に当接した状態となる。このときバルーン７は折り畳まれた状態となる。弾性を必要とするバルーン形成部５の弓状鋼線６には、弓状形状と直線形状との間の形状変化を確実に行なえるバネ鋼や超弾性合金を用いる。 FIG. 3 is an external view of a state in which the wire 4 is inserted into the catheter tube 3 and the balloon forming portion 5 at the tip is protruded from the tip of the catheter tube 3. The maximum diameter of the onion-shaped balloon forming part 5 is 5 to 30 mmφ, which is larger than the inner diameter of the catheter tube 3. For this reason, when passing through the catheter tube 3, the arcuate steel wire 6 of the balloon forming portion 5 is deformed into a substantially linear shape by elasticity as shown in FIG. 4, and the reduced onion shape is formed on the inner wall of the catheter tube 3. It comes into contact. At this time, the balloon 7 is folded. For the arcuate steel wire 6 of the balloon forming portion 5 that requires elasticity, spring steel or a superelastic alloy that can reliably change the shape between the arcuate shape and the linear shape is used.
次に、この血管閉塞器具１を用いて所定の血管部位の血流を止める手順について説明する。まず、カテーテルチューブ３を血管に挿入し、先端を止血部位に位置決めする。カテーテルチューブ３を止血部位にまで挿入するには、図５に示すようにガイドワイヤ１０を血管１１内に挿入し、そのガイドワイヤ１０をガイドとして血管内にカテーテルチューブ３を挿入し先端を目的部位に誘導する。または、ガイドワイヤ１０の先端をカテーテルチューブ３の先端より突出させた状態で血管内に挿入し、ガイドワイヤ１０と共にカテーテルチューブ３の先端を目的部位に誘導する。 Next, a procedure for stopping blood flow in a predetermined blood vessel site using the blood vessel occlusion device 1 will be described. First, the catheter tube 3 is inserted into a blood vessel, and the tip is positioned at a hemostatic site. In order to insert the catheter tube 3 to the hemostatic site, the guide wire 10 is inserted into the blood vessel 11 as shown in FIG. 5, the catheter tube 3 is inserted into the blood vessel using the guide wire 10 as a guide, and the tip is placed at the target site. To guide. Alternatively, the distal end of the guide wire 10 is inserted into the blood vessel in a state of protruding from the distal end of the catheter tube 3, and the distal end of the catheter tube 3 is guided to the target site together with the guide wire 10.
カテーテルチューブ３の先端を目的部位に位置決めしたならガイドワイヤ１０を抜き取り、代わりに図６に示すようにバルーン形成部５を付けたワイヤ４をカテーテルチューブ３に挿入する。そしてバルーン形成部５をゆっくりした速度でカテーテルチューブ３の先端から突出させる。突出によりバルーン形成部５を構成する弓状鋼線６はカテーテルチューブ３内壁による束縛から開放され、その弾性により直線形状から弓状形状へと形状変化する。これによりバルーン形成部５は拡径して図７に示すようにタマネギ形状に変形し、バルーン７も折り畳まれた状態からタマネギ形状に変化する。この形状変化の際、バルーン７内部にはバルーン膜が形成されていない骨組部９を通して血液が流れ込む。拡径したバルーン形成部５は、弓状鋼線６の弾性力により血管内壁を僅かに押し拡げ、バルーン７は血管内壁に密接して血流を遮断する。血流を再開させる場合は、ワイヤ４を引いてバルーン形成部５をカテーテルチューブ３内に引き入れる。以上のような操作により血流の停止と再開を行うことができる。 When the distal end of the catheter tube 3 is positioned at the target site, the guide wire 10 is pulled out, and instead the wire 4 with the balloon forming portion 5 is inserted into the catheter tube 3 as shown in FIG. And the balloon formation part 5 is protruded from the front-end | tip of the catheter tube 3 at a slow speed. The arcuate steel wire 6 constituting the balloon forming portion 5 is released from the restraint by the inner wall of the catheter tube 3 by the protrusion, and the shape changes from a linear shape to an arcuate shape due to its elasticity. As a result, the diameter of the balloon forming portion 5 is expanded and deformed into an onion shape as shown in FIG. 7, and the balloon 7 is also changed from a folded state to an onion shape. During this shape change, blood flows into the inside of the balloon 7 through the skeleton 9 where no balloon membrane is formed. The expanded balloon forming portion 5 slightly expands the inner wall of the blood vessel by the elastic force of the arcuate steel wire 6, and the balloon 7 is in close contact with the inner wall of the blood vessel and blocks the blood flow. When resuming blood flow, the wire 4 is pulled and the balloon forming part 5 is pulled into the catheter tube 3. The blood flow can be stopped and restarted by the above operation.
以上説明した本発明の血管閉塞器具１は、バルーン７の拡径、膨張を弓状鋼線６の弾性力のみで行なうため構造が簡単で操作も容易である。また、カテーテルチューブ３内に挿入されるのはバルーン形成部５とワイヤ４のみであるため、従来のカテーテルに比べてその径を細くできる利点を有する。 The vascular occlusion device 1 of the present invention described above is simple in structure and easy to operate because the diameter of the balloon 7 is expanded and expanded only by the elastic force of the arcuate steel wire 6. Further, since only the balloon forming portion 5 and the wire 4 are inserted into the catheter tube 3, it has an advantage that its diameter can be reduced as compared with the conventional catheter.
図面中、１は血管閉塞器具、３はカテーテルチューブ、４はワイヤ、５はバルーン形成部、６は弓状鋼線、７はバルーン、８は拡縮ワイヤ部（タマネギ形状骨組）、１１は血管を示す。 In the drawings, 1 is a vascular occlusion device, 3 is a catheter tube, 4 is a wire, 5 is a balloon forming part, 6 is an arcuate steel wire, 7 is a balloon, 8 is an expansion / contraction wire part (onion-shaped skeleton), and 11 is a blood vessel. Show.
Claims (2)
血管内に挿入する可とう性のカテーテルチューブと、該カテーテルチューブに挿通するワイヤと、該ワイヤの先端に取り付けたバルーン形成部とから構成され、
前記バルーン形成部は、弾性を有する４〜８本の弓状鋼線を周方向に等間隔に配して全体として略タマネギ形状に形成し、該タマネギ形状部の表面には前記ワイヤの反対側一部を除く表面を覆うバルーンを形成し、前記各弓状鋼線の一方の端部はまとめて前記ワイヤの先端に固着し、他方の端部は棒状又はコイル状に撚り合わせて互いに固着してあることを特徴とする血管閉塞器具。 A vascular occlusion device for inserting into a blood vessel to temporarily block blood flow at a target site,
A flexible catheter tube to be inserted into the blood vessel, a wire inserted through the catheter tube, and a balloon forming portion attached to the tip of the wire;
The balloon forming part is formed in a substantially onion shape as a whole by arranging 4 to 8 arcuate steel wires having elasticity at equal intervals in the circumferential direction, and the surface of the onion shape part is opposite to the wire. A balloon covering the surface excluding a part is formed, and one end of each arcuate steel wire is fixed to the tip of the wire together, and the other end is twisted in a rod shape or a coil shape and fixed to each other. A vaso-occlusive device characterized by that.
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| Application Number | Priority Date | Filing Date | Title |
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| JP2013004142A JP2014133065A (en) | 2013-01-14 | 2013-01-14 | Vascular occlusion device |
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| Application Number | Priority Date | Filing Date | Title |
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| JP2013004142A JP2014133065A (en) | 2013-01-14 | 2013-01-14 | Vascular occlusion device |
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| JP2014133065A true JP2014133065A (en) | 2014-07-24 |
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