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JP6937151B2 - Medical tubular members, foreign body removal devices and foreign body removal catheters - Google Patents
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JP6937151B2 - Medical tubular members, foreign body removal devices and foreign body removal catheters - Google Patents

Medical tubular members, foreign body removal devices and foreign body removal catheters Download PDF

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JP6937151B2
JP6937151B2 JP2017072631A JP2017072631A JP6937151B2 JP 6937151 B2 JP6937151 B2 JP 6937151B2 JP 2017072631 A JP2017072631 A JP 2017072631A JP 2017072631 A JP2017072631 A JP 2017072631A JP 6937151 B2 JP6937151 B2 JP 6937151B2
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tubular member
foreign matter
slits
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slit
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JP2018171349A5 (en
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宏輝 石田
宏輝 石田
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SB Kawasumi Laboratories Inc
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Description

本発明は、医療用管状部材、異物除去デバイス及び異物除去用カテーテルに関する。 The present invention relates to a medical tubular member, a foreign body removing device and a foreign body removing catheter.

従来、血管などの管状組織内に挿入される医療用管状部材として、例えば、血管壁から血栓を除去するための血栓除去デバイスが知られている(例えば、特許文献1参照)。 Conventionally, as a medical tubular member inserted into a tubular tissue such as a blood vessel, for example, a thrombus removing device for removing a thrombus from a blood vessel wall is known (see, for example, Patent Document 1).

特表2016−513524号公報Special Table 2016-513524

ところで、細く曲がりくねっている血管の血管壁を傷つけずに血栓が存在する所定の位置まで血栓除去デバイスを挿入する上で、血栓除去デバイスは、円滑に屈曲可能な構造を有するのが望ましい。
そこで、血栓除去デバイスに複数のスリットを形成することが考えられるが、屈曲した際に、スリットの端部に応力が集中して亀裂などの破損が生じたり、スリットの対向する縁部が部分的に当接すると、当接した部分に荷重が集中して変形が生じたりするおそれがあった。
By the way, in order to insert the thrombectomy device to a predetermined position where a thrombus is present without damaging the blood vessel wall of a thin and winding blood vessel, it is desirable that the thrombectomy device has a structure that can be smoothly bent.
Therefore, it is conceivable to form a plurality of slits in the thrombectomy device, but when bent, stress is concentrated on the ends of the slits to cause damage such as cracks, or the opposing edges of the slits are partially formed. When the contact is made, the load may be concentrated on the contacted portion and deformation may occur.

このような課題は、血管以外の管状組織(例えば、消化管、胆管等)内に挿入される管状部材においても生じ得るものである。 Such problems can also occur in tubular members that are inserted into tubular tissues other than blood vessels (eg, gastrointestinal tract, bile duct, etc.).

本発明は、上述した事情に鑑みてなされたものであり、その目的は、円滑に屈曲させることができ、屈曲した際に破損や変形が発生することを抑制することができる医療用管状部材、その医療用管状部材を備えた異物除去デバイス及び異物除去用カテーテルを提供することにある。 The present invention has been made in view of the above circumstances, and an object of the present invention is to provide a medical tubular member which can be smoothly bent and can suppress breakage or deformation when bent. It is an object of the present invention to provide a foreign body removing device and a foreign body removing catheter provided with the medical tubular member.

前述した目的を達成するために、本発明に係る医療用管状部材、異物除去デバイス及び異物除去用カテーテルは、下記(1)〜(6)を特徴としている。
(1)管状組織に挿入される筒状の医療用管状部材であって、
前記管状組織に挿入され、軸線方向に略直交する径方向に拡縮可能な被挿入部材の挿入方向前方側及び挿入方向後方側のうち、少なくとも一方に一体形成され、
当該医療用管状部材の管壁を貫通し、軸線方向と斜めに交わる方向に沿う複数のスリットが形成され、
前記複数のスリットの各々は、
互いに対向する縁部が、前記スリットの延在方向の両端部へ向かって次第に近接されて幅が狭くされ、
前記両端部が丸孔形状をなすように膨らんでなることを特徴とする。
(2)周方向のいずれの位置においても、軸線方向と略平行な直線上に前記スリットが存在することを特徴とする。
(3)前記複数のスリットは、周方向へ螺旋状に連なるように配置されている
ことを特徴とする。
(4)前記複数のスリットは、軸線方向に隣合うものどうしが周方向にずれて配置されていることを特徴とする。
(5)管状組織内の異物を除去又は回収可能に構成されている異物除去デバイスであって、
前記管状組織に挿入され、軸線方向に略直交する径方向に拡縮可能な被挿入部材と、
前記被挿入部材の挿入方向前方側及び挿入方向後方側のうち、少なくとも一方に一体形成され、前記管状組織に挿入される筒状の管状部材と、を備え、
前記管状部材には、その管壁を貫通し、軸線方向と斜めに交わる方向に沿う複数のスリットが形成され、
前記複数のスリットの各々は、
互いに対向する縁部が、前記スリットの延在方向の両端部へ向かって次第に近接されて幅が狭くされ、
前記両端部が丸孔形状をなすように膨らんでなることを特徴とする。
(6)管状組織内の異物を除去又は回収するための異物除去用カテーテルであって、
カテーテル本体と、
前記カテーテル本体の遠位部に配置され、前記管状組織内の異物を除去又は回収可能に構成されている異物除去デバイスと、を備え、
前記異物除去デバイスは、
前記管状組織に挿入され、軸線方向に略直交する径方向に拡縮可能な被挿入部材と、
前記被挿入部材の挿入方向前方側及び挿入方向後方側のうち、少なくとも一方に一体形成され、前記管状組織に挿入される筒状の管状部材と、を備え、
前記管状部材には、その管壁を貫通し、軸線方向と斜めに交わる方向に沿う複数のスリットが形成され、
前記複数のスリットの各々は、
互いに対向する縁部が、前記スリットの延在方向の両端部へ向かって次第に近接されて幅が狭くされ、
前記両端部が丸孔形状をなすように膨らんでなることを特徴とする。
In order to achieve the above-mentioned object, the medical tubular member, the foreign matter removing device and the foreign matter removing catheter according to the present invention are characterized by the following (1) to (6).
(1) A tubular medical tubular member that is inserted into a tubular tissue.
The inserted member inserted into the tubular tissue and expandable and contractible in the radial direction substantially orthogonal to the axial direction is integrally formed on at least one of the front side in the insertion direction and the rear side in the insertion direction.
A plurality of slits are formed through the tube wall of the medical tubular member and along the direction diagonally intersecting the axial direction.
Each of the plurality of slits
The edges facing each other are gradually brought closer to each other toward both ends in the extending direction of the slit, and the width is narrowed.
It is characterized in that both ends thereof bulge so as to form a round hole shape.
(2) The slit is characterized in that the slit exists on a straight line substantially parallel to the axial direction at any position in the circumferential direction.
(3) The plurality of slits are arranged so as to be spirally connected in the circumferential direction.
(4) The plurality of slits are characterized in that adjacent ones in the axial direction are arranged so as to be displaced in the circumferential direction.
(5) A foreign matter removing device configured to remove or recover foreign matter in a tubular tissue.
A member to be inserted that is inserted into the tubular tissue and can be expanded or contracted in the radial direction substantially orthogonal to the axial direction.
Wherein among the insertion direction front side and the insertion direction rear side of the insertion member is formed integrally on at least one, and a cylindrical tubular member which is inserted into the tubular tissue,
The tubular member is formed with a plurality of slits penetrating the tube wall and along a direction diagonally intersecting the axial direction.
Each of the plurality of slits
The edges facing each other are gradually brought closer to each other toward both ends in the extending direction of the slit, and the width is narrowed.
It is characterized in that both ends thereof bulge so as to form a round hole shape.
(6) A foreign matter removing catheter for removing or collecting foreign matter in a tubular tissue.
Catheter body and
A foreign body removing device located at the distal portion of the catheter body and configured to remove or recover foreign body in the tubular tissue.
The foreign matter removing device is
A member to be inserted that is inserted into the tubular tissue and can be expanded or contracted in the radial direction substantially orthogonal to the axial direction.
Wherein among the insertion direction front side and the insertion direction rear side of the insertion member is formed integrally on at least one, and a cylindrical tubular member which is inserted into the tubular tissue,
The tubular member is formed with a plurality of slits penetrating the tube wall and along a direction diagonally intersecting the axial direction.
Each of the plurality of slits
The edges facing each other are gradually brought closer to each other toward both ends in the extending direction of the slit, and the width is narrowed.
It is characterized in that both ends thereof bulge so as to form a round hole shape.

上記(1)の構成の医療用管状部材によれば、管状組織に挿入され、軸線方向に略直交する径方向に拡縮可能な被挿入部材の挿入方向前方側及び挿入方向後方側のうち、少なくとも一方に一体形成され、当該医療用管状部材の管壁を貫通し、軸線方向と斜めに交わる方向に沿う複数のスリットが形成されているので、良好な可撓性が付与され、管状組織が湾曲していてもこの管状組織内で円滑に屈曲させることができる。また、スリットの延在方向の両端部が丸孔形状をなすように膨らんでなるので、屈曲した際に端部側に生じる応力、特に、端部に集中する応力が周囲に分散され、この端部での亀裂などの破損を抑制することができる。さらに、スリットの互いに対向する縁部が、スリットの延在方向の両端部へ向かって次第に近接されて幅が狭くされているので、スリットの両端部側で互いに対向する縁部どうしが密着し易くなり、スリットの縁部が部分的に当接して、当接した部分に荷重が集中することで生じる変形を抑制することができる。
上記(2)の構成の医療用管状部材によれば、周方向のいずれの位置においても、軸線方向と略平行な直線上にスリットが存在することより、軸線方向のどの位置においても、軸線方向と交わるあらゆる方向へ円滑に屈曲させることができ、高い可撓性を得ることができる。
上記(3)の構成の医療用管状部材によれば、複数のスリットを周方向へ螺旋状に連なるように配置することで、屈曲の自由度を高め、より円滑に軸線方向と交わるあらゆる方向へ屈曲させることができる。
上記(4)の構成の医療用管状部材によれば、複数のスリットの軸線方向に隣合うものどうしが周方向にずれて配置されているので、屈曲の自由度を高め、より円滑に軸線方向と交わるあらゆる方向へ屈曲させることができる。
上記(5)の構成の異物除去デバイスによれば、(1)と同様の効果が得られるだけでなく、管状組織における異物の除去又は回収を要する所定位置へ異物除去デバイスを挿入する際に、管状組織が湾曲していても異物除去デバイスの医療用管状部材を円滑に屈曲させることができ、異物除去デバイスを管状組織における所定位置へ円滑に搬送することができる。これにより、管状組織内の異物を容易に除去又は回収することができる。
上記(6)の構成の異物除去用カテーテルによれば、(1)と同様の効果が得られるだけでなく、上述した本発明の異物除去デバイスと略同様に、異物除去デバイスを円滑に管状組織における異物の除去又は回収を要する所定位置へ挿入し、管状組織内の異物を容易に除去又は回収することができる。
According to the medical tubular member having the configuration of (1) above , at least one of the front side in the insertion direction and the rear side in the insertion direction of the inserted member which is inserted into the tubular tissue and can be expanded and contracted in the radial direction substantially orthogonal to the axial direction. It is integrally formed on one side, penetrates the tube wall of the medical tubular member, and a plurality of slits are formed along the direction diagonally intersecting the axial direction, so that good flexibility is imparted and the tubular tissue is curved. Even if it does, it can be smoothly bent in this tubular tissue. Further, since both ends of the slit in the extending direction bulge so as to form a round hole shape, the stress generated on the end side when bent, particularly the stress concentrated on the end is dispersed to the surroundings, and this end. It is possible to suppress damage such as cracks in the part. Further, since the edges of the slits facing each other are gradually brought closer to each other toward both ends in the extending direction of the slit and the width is narrowed, the edges facing each other on both ends of the slit can easily come into close contact with each other. Therefore, it is possible to suppress the deformation caused by the edge portion of the slit partially abutting and the load being concentrated on the abutting portion.
According to the medical tubular member having the configuration of (2) above, since the slit exists on a straight line substantially parallel to the axial direction at any position in the circumferential direction, the axial direction can be obtained at any position in the axial direction. It can be smoothly bent in all directions where it intersects with, and high flexibility can be obtained.
According to the medical tubular member having the configuration of (3) above, by arranging a plurality of slits in a spiral shape in the circumferential direction, the degree of freedom of bending is increased and the direction of intersection with the axial direction is smoother. Can be bent.
According to the medical tubular member having the configuration of (4) above, since the plurality of slits adjacent to each other in the axial direction are arranged so as to be offset in the circumferential direction, the degree of freedom of bending is increased and the axial direction is smoother. Can be bent in any direction that intersects with.
According to the foreign matter removing device having the configuration of (5) above, not only the same effect as that of (1) can be obtained, but also when the foreign matter removing device is inserted into a predetermined position in the tubular tissue where foreign matter needs to be removed or collected, the foreign matter removing device is inserted. Even if the tubular tissue is curved, the medical tubular member of the foreign matter removing device can be smoothly bent, and the foreign matter removing device can be smoothly transported to a predetermined position in the tubular tissue. Thereby, the foreign matter in the tubular tissue can be easily removed or recovered.
According to the foreign matter removing catheter having the configuration of (6) above, not only the same effect as (1) can be obtained, but also the foreign matter removing device can be smoothly tubularized in substantially the same manner as the foreign matter removing device of the present invention described above. The foreign matter in the tubular tissue can be easily removed or recovered by inserting the foreign matter into a predetermined position requiring removal or recovery of the foreign matter in the above.

本発明によれば、円滑に屈曲させることができ、屈曲した際に破損や変形が発生することを抑制することができる。 According to the present invention, it can be smoothly bent, and it is possible to suppress the occurrence of breakage or deformation when bent.

以上、本発明について簡潔に説明した。更に、以下に説明される発明を実施するための形態(以下、「実施形態」という。)を添付の図面を参照して通読することにより、本発明の詳細は更に明確化されるであろう。 The present invention has been briefly described above. Further, the details of the present invention will be further clarified by reading through the embodiments described below (hereinafter referred to as "embodiments") with reference to the accompanying drawings. ..

図1は、本実施形態に係る医療用管状部材を説明する図であって、図1(a)は医療用管状部材の側面図、図1(b)は図1(a)における一部の拡大図である。1A and 1B are views for explaining a medical tubular member according to the present embodiment, FIG. 1A is a side view of the medical tubular member, and FIG. 1B is a part of FIG. 1A. It is an enlarged view. 図2は、本実施形態に係る医療用管状部材に形成されるスリットの形状を示す図である。FIG. 2 is a diagram showing the shape of a slit formed in the medical tubular member according to the present embodiment. 図3は、本実施形態に係る医療用管状部材のスリットの配列を模式的に示す図である。FIG. 3 is a diagram schematically showing an arrangement of slits of a medical tubular member according to the present embodiment. 図4は、本実施形態に係る医療用管状部材を屈曲させた状態の側面図である。FIG. 4 is a side view of the medical tubular member according to the present embodiment in a bent state. 図5は、参考例に係る医療用管状部材を屈曲させた状態の側面図である。FIG. 5 is a side view of the medical tubular member according to the reference example in a bent state. 図6は、本実施形態に係る異物除去用カテーテルを説明する概略構成図である。FIG. 6 is a schematic configuration diagram illustrating a foreign matter removing catheter according to the present embodiment. 図7は、本実施形態に係る異物除去用カテーテルの内部構造を示す図であって、図7(a)はリトリバーの拡張時における断面図、図7(b)はリトリバーの収縮時における断面図である。7A and 7B are views showing the internal structure of the foreign matter removing catheter according to the present embodiment, FIG. 7A is a cross-sectional view when the retriever is expanded, and FIG. 7B is a cross-sectional view when the retriever is contracted. Is. 図8は、異物除去用カテーテルの使用方法を説明する図であって、図8(a)〜図8(f)は、それぞれ管状組織における異物の除去位置での概略断面図である。8A and 8B are views for explaining how to use the foreign matter removing catheter, and FIGS. 8A to 8F are schematic cross-sectional views of foreign matter removing positions in the tubular tissue, respectively. 図9は、変形例に係る医療用管状部材のスリットの配列を模式的に示す図である。FIG. 9 is a diagram schematically showing an arrangement of slits of a medical tubular member according to a modified example. 図10は、医療用管状部材に形成される他のスリットの形状を示す図である。FIG. 10 is a diagram showing the shape of another slit formed in the medical tubular member.

以下、本発明に係る実施の形態の例を、図面を参照して説明する。 Hereinafter, examples of embodiments according to the present invention will be described with reference to the drawings.

(医療用管状部材)
図1は、本実施形態に係る医療用管状部材を説明する図であって、図1(a)は医療用管状部材の側面図、図1(b)は図1(a)における一部の拡大図である。
(Medical tubular member)
1A and 1B are views for explaining a medical tubular member according to the present embodiment, FIG. 1A is a side view of the medical tubular member, and FIG. 1B is a part of FIG. 1A. It is an enlarged view.

図1(a)(b)に示すように、本実施形態に係る医療用管状部材(以下、単に管状部材と称す)10は、例えば、断面円形状のパイプ状部材である。管状部材10は、血管などの管状組織内に挿入される部材である。 As shown in FIGS. 1A and 1B, the medical tubular member (hereinafter, simply referred to as a tubular member) 10 according to the present embodiment is, for example, a pipe-shaped member having a circular cross section. The tubular member 10 is a member that is inserted into a tubular tissue such as a blood vessel.

管状部材10を構成する材料としては、例えば、ステンレス鋼、チタン合金、Ni−Ti合金、Ni−Ti−Co合金、Ni−Ti−Cu合金、Au−Cd合金、Cu−Al−Ni合金などに代表される公知の金属又は金属合金を好ましく用いることができる。また、材料としてX線造影性を有する合金を用いることにより、X線不透過マーカーとしてもよい。この場合、管状部材10の位置を体外から確認することが可能となる。 Examples of the material constituting the tubular member 10 include stainless steel, titanium alloy, Ni-Ti alloy, Ni-Ti-Co alloy, Ni-Ti-Cu alloy, Au-Cd alloy, Cu-Al-Ni alloy and the like. A representative known metal or metal alloy can be preferably used. Further, by using an alloy having X-ray contrast property as a material, it may be used as an X-ray opaque marker. In this case, the position of the tubular member 10 can be confirmed from outside the body.

管状部材10の管壁11には、複数のスリット20が形成されている。これらのスリット20は、例えば、レーザー加工によって、それぞれ管状部材10の管壁11を内外に貫通して形成されている。また、複数のスリット20は、それぞれ管状部材10の軸線X方向と交わる方向に沿って形成されている。具体的には、複数のスリット20は、略等しい形状及び寸法を有し、周方向へ螺旋状に連なるように形成されている(詳細後述;図3参照)。
なお、スリット20の加工方法としては、例えば、レーザー加工を好ましく用いることができるが、他の加工方法によって形成してもよい。
A plurality of slits 20 are formed in the tube wall 11 of the tubular member 10. These slits 20 are formed by, for example, laser machining, penetrating the tube wall 11 of the tubular member 10 in and out. Further, the plurality of slits 20 are formed along a direction intersecting the axis X direction of the tubular member 10, respectively. Specifically, the plurality of slits 20 have substantially the same shape and dimensions, and are formed so as to be spirally connected in the circumferential direction (details will be described later; see FIG. 3).
As the processing method of the slit 20, for example, laser processing can be preferably used, but it may be formed by another processing method.

図2は、本実施形態に係る医療用管状部材に形成されるスリットの形状を示す図である。
図2に示すように、スリット20の両端には、丸孔形状(例えば、平面視にて円形状)をなすように膨らんだ孔部21が形成されている。
具体的には、孔部21は、例えば、当該孔部21を円形と仮想した場合の半円よりも面積が大きくなるように、径や中心位置等が規定されているのが好ましい。すなわち、例えば、孔部21を円形と仮想した場合の径が、スリット20の互いに対向する縁部22(後述)の最も狭くなっている部分の幅よりも大きく、且つ、当該孔部21の中心位置が互いに対向する縁部22の外側(図2における上側や下側)に配置されているのが好ましい。
なお、図示は省略するが、縁部22の最も狭くなっている部分の幅に対して、孔部21を円形と仮想した場合の径が略等しくなっていてもよい。
FIG. 2 is a diagram showing the shape of a slit formed in the medical tubular member according to the present embodiment.
As shown in FIG. 2, both ends of the slit 20 are formed with hole portions 21 bulging so as to form a round hole shape (for example, a circular shape in a plan view).
Specifically, for example, it is preferable that the diameter, the center position, and the like of the hole 21 are defined so that the area of the hole 21 is larger than that of a semicircle when the hole 21 is assumed to be circular. That is, for example, when the hole 21 is assumed to be circular, the diameter is larger than the width of the narrowest portion of the slit 20 facing each other (described later), and the center of the hole 21. It is preferable that the positions are arranged on the outer side (upper side or lower side in FIG. 2) of the edge portions 22 facing each other.
Although not shown, the diameter of the hole 21 may be substantially equal to the width of the narrowest portion of the edge 22 when the hole 21 is assumed to be circular.

また、スリット20は、その互いに対向する縁部22が中央側から端部へ向かって次第に幅が狭まる形状に形成されている。具体的には、スリット20の互いに対向する縁部22は、当該スリット20の延在方向の略中央部が最も幅広とされている。この略中央部の幅は、例えば、孔部21を円形と仮想した場合の径よりも大きくなっている。また、スリット20の互いに対向する縁部22は、当該スリット20の延在方向の略中央部を境にし、この延在方向に対して略等しい角度で傾斜するように直線状に延びている。すなわち、スリット20の延在方向の略中央部を境にして、各端部側で略「ハ」字状をなすように互いに対向する縁部22が傾斜している。
なお、スリット20の互いに対向する縁部22は、例えば、略円弧状に形成されていてもよい。
Further, the slit 20 is formed in such a shape that the edge portions 22 facing each other gradually narrow in width from the central side toward the end portion. Specifically, the edges 22 of the slits 20 facing each other have the widest substantially central portion in the extending direction of the slit 20. The width of the substantially central portion is larger than, for example, the diameter when the hole portion 21 is assumed to be circular. Further, the edges 22 of the slits 20 facing each other extend linearly so as to be inclined at substantially the same angle with respect to the extending direction with the substantially central portion of the slit 20 in the extending direction as a boundary. That is, the edge portions 22 facing each other are inclined so as to form a substantially "H" shape on each end side with the substantially central portion in the extending direction of the slit 20 as a boundary.
The edges 22 of the slits 20 facing each other may be formed in a substantially arc shape, for example.

管状部材10は、例えば、外径1.6mm(内径1.4mm)から外径2.45mm(内径2.05mm)程度のパイプである。また、管状部材10に形成されたスリット20の両端の孔部21は、その径が、例えば、0.14mmとされている。なお、この孔部21は、0.08mm以上0.20mm以下の径であることが好ましい。 The tubular member 10 is, for example, a pipe having an outer diameter of 1.6 mm (inner diameter of 1.4 mm) to an outer diameter of 2.45 mm (inner diameter of 2.05 mm). Further, the diameters of the holes 21 at both ends of the slit 20 formed in the tubular member 10 are set to, for example, 0.14 mm. The hole portion 21 preferably has a diameter of 0.08 mm or more and 0.20 mm or less.

図3は、本実施形態に係る医療用管状部材のスリットの配列を模式的に示す図である。
図3に示すように、スリット20は、軸線Xと直交する直線Aに対して僅かに傾いて形成されている。これらの複数のスリット20は、同一形状及び同一寸法とされている。これにより、管状部材10では、スリット20が周方向へ螺旋状に連なるように形成され、互いに周方向へ螺旋状に連なるスリット20どうしの間のスリット間領域部24が螺旋状に配置されている。そして、スリット20は、管状部材10の周方向のいずれの位置においても、軸線X方向と略平行な直線B上にスリット20が存在するように配置されている。なお、複数のスリット20は、互いに形状が異なっていてもよく、また、互いに寸法が異なっていてもよい。
FIG. 3 is a diagram schematically showing an arrangement of slits of a medical tubular member according to the present embodiment.
As shown in FIG. 3, the slit 20 is formed so as to be slightly inclined with respect to the straight line A orthogonal to the axis X. These plurality of slits 20 have the same shape and the same dimensions. As a result, in the tubular member 10, the slits 20 are formed so as to be spirally connected in the circumferential direction, and the interslit region portion 24 between the slits 20 spirally connected to each other in the circumferential direction is spirally arranged. .. The slit 20 is arranged so that the slit 20 exists on a straight line B substantially parallel to the axis X direction at any position in the circumferential direction of the tubular member 10. The plurality of slits 20 may have different shapes and may have different dimensions.

図4は、本実施形態に係る医療用管状部材を屈曲させた状態の側面図である。
図4に示すように、軸線X方向と交わる方向に沿う複数のスリット20を有する管状部材10は、曲げ力が付与されることで、伸長する側(図4中、上側)においてスリット20が開かれるとともに、屈曲する側(図4中、下側)においてスリット20が閉じられる。
FIG. 4 is a side view of the medical tubular member according to the present embodiment in a bent state.
As shown in FIG. 4, in the tubular member 10 having a plurality of slits 20 along the direction intersecting the axis X direction, the slits 20 are opened on the extending side (upper side in FIG. 4) by applying a bending force. At the same time, the slit 20 is closed on the bending side (lower side in FIG. 4).

このように、本実施形態に係る医療用管状部材10によれば、軸線X方向と交わる方向に沿う複数のスリット20を有することで、良好な可撓性が付与され、細く曲がりくねった血管に対しても、その形状に沿って屈曲されて血管壁を傷つけることなく円滑に挿入される。 As described above, according to the medical tubular member 10 according to the present embodiment, by having a plurality of slits 20 along the direction intersecting the axis X direction, good flexibility is imparted to the thin and winding blood vessel. However, it is bent along its shape and smoothly inserted without damaging the blood vessel wall.

ここで、両端に孔部21がないストレートのスリット20を有している参考例に係る管状部材10Aについて、図5を参照して説明する。
図5は、参考例に係る医療用管状部材を屈曲させた状態の側面図である。
Here, a tubular member 10A according to a reference example having straight slits 20 having no holes 21 at both ends will be described with reference to FIG.
FIG. 5 is a side view of the medical tubular member according to the reference example in a bent state.

図5に示すように、この参考例に係る管状部材10Aでは、スリット20の両端に孔部21がないため、伸長する側において、開かれるスリット20の両端に集中する応力によってスリット20が裂けるような破損が生じるおそれがある。また、屈曲する側において、スリット20の縁部22どうしの間に隙間が生じ、スリット20の縁部22どうしが部分的に当接することとなり、その当接した部分に荷重が集中的に作用して変形が生じるおそれがある。 As shown in FIG. 5, in the tubular member 10A according to this reference example, since there are no holes 21 at both ends of the slit 20, the slit 20 is torn by the stress concentrated on both ends of the slit 20 to be opened on the extending side. There is a risk of damage. Further, on the bending side, a gap is generated between the edge portions 22 of the slit 20, and the edge portions 22 of the slit 20 are partially in contact with each other, and the load is concentrated on the contacted portion. May cause deformation.

これに対して、本実施形態に係る管状部材10によれば、スリット20の延伸方向の両端部が丸孔形状をなすように膨らんでなるので、屈曲した際に端部側に生じる応力、特に、端部に集中する応力が周囲に分散され、この端部での亀裂などの破損を抑制することができる。さらに、スリット20の両端部側で互いに対向する縁部が、端部へ向かって次第に近接されて幅が狭くされているので、スリット20の両端部側で互いに対向する縁部22どうしが密着し易くなり、スリット20の縁部22が部分的に当接して、当接した部分に荷重が集中することで生じる変形を抑制することができる。 On the other hand, according to the tubular member 10 according to the present embodiment, both ends of the slit 20 in the extending direction bulge so as to form a round hole shape, so that stress generated on the end side when bent, particularly , The stress concentrated on the end is dispersed to the surroundings, and damage such as cracks at the end can be suppressed. Further, since the edges facing each other on both ends of the slit 20 are gradually approached toward the ends and the width is narrowed, the edges 22 facing each other on both ends of the slit 20 are in close contact with each other. This facilitates the process, and the edge portion 22 of the slit 20 is partially in contact with each other, and the deformation caused by the concentration of the load on the abutted portion can be suppressed.

また、本実施形態に係る医療用管状部材10によれば、周方向のいずれの位置においても、軸線X方向と略平行な直線B上にスリット20が存在するので、軸線X方向のどの位置においても、軸線X方向と交わるあらゆる方向へ円滑に屈曲させることができ、高い可撓性を得ることができる。 Further, according to the medical tubular member 10 according to the present embodiment, since the slit 20 exists on the straight line B substantially parallel to the axis X direction at any position in the circumferential direction, at any position in the axis X direction. However, it can be smoothly bent in any direction intersecting the X direction of the axis, and high flexibility can be obtained.

また、本実施形態に係る医療用管状部材10によれば、スリット20が周方向へ螺旋状に連なるように配置されている。これにより、屈曲の自由度を高め、より円滑に軸線X方向と交わるあらゆる方向へ屈曲させることができる。 Further, according to the medical tubular member 10 according to the present embodiment, the slits 20 are arranged so as to be spirally connected in the circumferential direction. As a result, the degree of freedom of bending can be increased, and the bending can be performed more smoothly in all directions intersecting the X direction of the axis.

また、本実施形態に係る医療用管状部材10によれば、例えば、血管等の管状組織に挿入される被挿入部材における挿入方向前方側及び挿入方向後方側にそれぞれ設けて用いることができる。この場合、管状組織が湾曲していてもこの管状組織へ挿入される被挿入部材の医療用管状部材10を円滑に屈曲させることができ、被挿入部材を管状組織における所定位置へ円滑に搬送することができる。 Further, according to the medical tubular member 10 according to the present embodiment, for example, the member to be inserted to be inserted into a tubular tissue such as a blood vessel can be provided on the front side in the insertion direction and the rear side in the insertion direction, respectively. In this case, even if the tubular tissue is curved, the medical tubular member 10 of the inserted member to be inserted into the tubular tissue can be smoothly bent, and the inserted member is smoothly conveyed to a predetermined position in the tubular tissue. be able to.

(異物除去デバイス、異物除去用カテーテル)
次に、医療用管状部材10を備えた異物除去デバイス及び異物除去用カテーテルについて説明する。
図6は、本実施形態に係る異物除去用カテーテルを説明する概略構成図である。図7は、本実施形態に係る異物除去用カテーテルの内部構造を示す図であって、図7(a)はリトリバーの拡張時における断面図、図7(b)はリトリバーの収縮時における断面図である。
(Foreign matter removal device, foreign matter removal catheter)
Next, a foreign matter removing device and a foreign matter removing catheter provided with the medical tubular member 10 will be described.
FIG. 6 is a schematic configuration diagram illustrating a foreign matter removing catheter according to the present embodiment. 7A and 7B are views showing the internal structure of the foreign matter removing catheter according to the present embodiment, FIG. 7A is a cross-sectional view when the retriever is expanded, and FIG. 7B is a cross-sectional view when the retriever is contracted. Is.

図6に示すように、異物除去用カテーテル50は、カテーテル本体60と、カテーテル本体60の遠位部に配置された異物除去デバイス100と、カテーテル本体60の近位部に配置された操作部70とを備える。 As shown in FIG. 6, the foreign matter removing catheter 50 includes a catheter main body 60, a foreign matter removing device 100 arranged at a distal portion of the catheter main body 60, and an operation unit 70 arranged at a proximal portion of the catheter main body 60. And.

なお、この明細書において「遠位部」とは、異物除去用カテーテル50の使用者からみて遠いほうの端部側の領域を指し、「近位部」とは、異物除去用カテーテル50の使用者からみて近いほうの端部側(手元側)の領域を指す。 In this specification, the "distal portion" refers to the region on the end side farther from the user of the foreign matter removing catheter 50, and the "proximal portion" refers to the use of the foreign matter removing catheter 50. Refers to the area on the end side (hand side) that is closer to the person.

異物除去用カテーテル50は、例えば、血管内に発生した血栓又は塞栓などの異物を異物除去デバイス100で除去又は回収するための血栓除去用カテーテルである。 The foreign matter removing catheter 50 is, for example, a thrombus removing catheter for removing or collecting a foreign matter such as a thrombus or an embolus generated in a blood vessel with the foreign matter removing device 100.

異物除去デバイス100は、前述した本実施形態に係る管状部材10と、管状部材10に設けられたリトリバー120とを備える。リトリバー120は、管状組織内に挿入される被挿入部材であり、拡張及び収縮が可能とされている。 The foreign matter removing device 100 includes the tubular member 10 according to the present embodiment described above, and the retriever 120 provided on the tubular member 10. The retriever 120 is a member to be inserted that is inserted into the tubular tissue and is capable of expanding and contracting.

また、図示による説明は省略するが、管状部材10とリトリバー120は、1本の金属パイプ(例えばNi−Ti合金からなるパイプ)をレーザー加工することによって形成することができる。この場合、管状部材10とリトリバー120とを一体形成することができる。 Although not illustrated, the tubular member 10 and retriever 120 can be formed by laser machining a single metal pipe (eg, a pipe made of a Ni—Ti alloy). In this case, the tubular member 10 and the retriever 120 can be integrally formed.

管状部材10は、リトリバー120に対して遠位部側が遠位管状部材10Fとされ、リトリバー120に対して近位部側が近位管状部材10Nとされている。 The tubular member 10 has a distal tubular member 10F on the distal side with respect to the retriever 120 and a proximal tubular member 10N on the proximal side with respect to the retriever 120.

図7(a)及び図7(b)に示すように、カテーテル本体60は、カテーテル本体60の遠位部から近位部まで伸びる第1チューブ62と、異物除去デバイス100と操作部70とを接続する第2チューブ64とを有する。第1チューブ62には、ガイドワイヤを挿通させるためのガイドワイヤ用ルーメンが設けられている。 As shown in FIGS. 7 (a) and 7 (b), the catheter body 60 includes a first tube 62 extending from the distal portion to the proximal portion of the catheter body 60, a foreign matter removing device 100, and an operation unit 70. It has a second tube 64 to be connected. The first tube 62 is provided with a lumen for a guide wire for inserting the guide wire.

異物除去デバイス100を構成する遠位管状部材10Fの遠位部側の端部は、第1チューブ62の遠位部の外周面に接続されている。異物除去デバイス100を構成する近位管状部材10Nの近位部側の端部は、第2チューブ64の遠位部の内周面に接続されている。第2チューブ64の内径は、第1チューブ62の外径よりも大きく設定されており、第1チューブ62と第2チューブ64との間に、所定寸法の隙間が設けられている。 The distal end of the distal tubular member 10F constituting the foreign matter removing device 100 is connected to the outer peripheral surface of the distal portion of the first tube 62. The proximal end of the proximal tubular member 10N constituting the foreign matter removing device 100 is connected to the inner peripheral surface of the distal portion of the second tube 64. The inner diameter of the second tube 64 is set to be larger than the outer diameter of the first tube 62, and a gap having a predetermined dimension is provided between the first tube 62 and the second tube 64.

第1チューブ62及び第2チューブ64は、ともに可撓性を有する材料で形成されている。可撓性材料としては、例えば、合成樹脂(エラストマー)、合成樹脂に他の材料が混合された樹脂コンパウンド、合成樹脂が多層で構成された多層構造体、または合成樹脂と金属線との複合体などを好ましく用いることができる。 Both the first tube 62 and the second tube 64 are made of a flexible material. Examples of the flexible material include a synthetic resin (elastomer), a resin compound in which another material is mixed with the synthetic resin, a multilayer structure composed of multiple layers of the synthetic resin, or a composite of the synthetic resin and a metal wire. Etc. can be preferably used.

操作部70は、例えばスティック状(棒状)の操作部本体72と、操作部本体72の側面に設置されたスライダー76と、操作部本体72の側面に設けられた液体充填ポート78とを有する。 The operation unit 70 has, for example, a stick-shaped (rod-shaped) operation unit main body 72, a slider 76 installed on the side surface of the operation unit main body 72, and a liquid filling port 78 provided on the side surface of the operation unit main body 72.

操作部本体72の側面には、長手方向(管軸方向)に沿って伸びる長孔74が設けられている。スライダー76は、長孔74を介して第1チューブ62に接続されており、長手方向(管軸方向)に沿って平行移動可能に構成されている。 An elongated hole 74 extending along the longitudinal direction (tube axis direction) is provided on the side surface of the operation unit main body 72. The slider 76 is connected to the first tube 62 via an elongated hole 74, and is configured to be able to translate along the longitudinal direction (tube axial direction).

液体充填ポート78は、第2チューブ64の内部ルーメン(第1チューブ62と第2チューブ64の隙間)に連通しており、液体充填ポート78を介してカテーテル本体60内に例えば生理食塩水等の液体を充填可能に構成されている。なお、図示による説明は省略するが、液体充填ポート78の開口端部は、キャップ等の封止部材又はシリコンゴム等からなる弁体によって液密に閉鎖されている。 The liquid filling port 78 communicates with the internal lumen of the second tube 64 (the gap between the first tube 62 and the second tube 64), and the inside of the catheter body 60 via the liquid filling port 78, for example, physiological saline or the like. It is configured so that it can be filled with liquid. Although the description by illustration is omitted, the open end of the liquid filling port 78 is liquid-tightly closed by a sealing member such as a cap or a valve body made of silicon rubber or the like.

ここで、スライダー76を移動させたときの異物除去デバイス100の動きについて、図7(a)及び図7(b)を用いて説明する。 Here, the movement of the foreign matter removing device 100 when the slider 76 is moved will be described with reference to FIGS. 7 (a) and 7 (b).

まず、図7(a)に示す状態において、スライダー76を矢印X1方向に移動させると、スライダー76に接続された第1チューブ62もX1方向に移動する。このとき、第1チューブ62と異物除去デバイス100との接続位置はX1方向に移動するが、第1チューブ62と第2チューブ64との接続位置は変化しない。つまり、第2チューブ64に対して第1チューブ62がX1方向に相対的に移動する結果、リトリバー120が収縮することとなる(図7(b)参照。)。 First, when the slider 76 is moved in the direction of the arrow X1 in the state shown in FIG. 7A, the first tube 62 connected to the slider 76 also moves in the X1 direction. At this time, the connection position between the first tube 62 and the foreign matter removing device 100 moves in the X1 direction, but the connection position between the first tube 62 and the second tube 64 does not change. That is, as a result of the first tube 62 moving relative to the second tube 64 in the X1 direction, the retriever 120 contracts (see FIG. 7B).

一方、図7(b)に示す状態において、スライダー76を矢印X2方向に移動させると、スライダー76に接続された第1チューブ62もX2方向に移動する。このとき、第1チューブ62と異物除去デバイス100との接続位置はX2方向に移動するが、第1チューブ62と第2チューブ64との接続位置は変化しない。つまり、第2チューブ64に対して第1チューブ62がX2方向に相対的に移動する結果、リトリバー120が拡張することとなる(図7(a)参照。)。 On the other hand, when the slider 76 is moved in the arrow X2 direction in the state shown in FIG. 7B, the first tube 62 connected to the slider 76 also moves in the X2 direction. At this time, the connection position between the first tube 62 and the foreign matter removing device 100 moves in the X2 direction, but the connection position between the first tube 62 and the second tube 64 does not change. That is, as a result of the first tube 62 moving relative to the second tube 64 in the X2 direction, the retriever 120 expands (see FIG. 7A).

すなわち、スライダー74を長手方向(管軸方向)に沿って平行移動させることにより、リトリバー120の拡張/収縮を操作することができる。 That is, the expansion / contraction of the retriever 120 can be operated by moving the slider 74 in parallel along the longitudinal direction (tube axis direction).

次に、異物除去用カテーテル50の使用方法の一例を、図8を用いて説明する。 Next, an example of how to use the foreign matter removing catheter 50 will be described with reference to FIG.

図8は、異物除去用カテーテルの使用方法を説明する図であって、図8(a)〜図8(f)は、それぞれ管状組織における異物の除去位置での概略断面図である。なお、図8(a)〜図8(f)において、発明の理解を容易にするため、異物除去用カテーテル50を構成する各部材の形状等を模式的に図示している。 8A and 8B are views for explaining how to use the foreign matter removing catheter, and FIGS. 8A to 8F are schematic cross-sectional views of foreign matter removing positions in the tubular tissue, respectively. 8 (a) to 8 (f) schematically show the shapes and the like of each member constituting the foreign matter removing catheter 50 in order to facilitate understanding of the invention.

まず、図8(a)に示すように、血管内にガイドワイヤWを通した状態で、ガイドワイヤWに沿わせてガイディングカテーテルGCを血管内に挿入し、所定位置である標的部位(異物CLが存在する部位)の手前まで異物除去用カテーテル50を送達する。 First, as shown in FIG. 8A, the guiding catheter GC is inserted into the blood vessel along the guide wire W with the guide wire W passed through the blood vessel, and the target site (foreign substance) at a predetermined position is inserted. The foreign matter removing catheter 50 is delivered to just before the site where CL is present).

次に、図8(b)に示すように、ガイディングカテーテルGCから異物除去用カテーテル50を送り出し、リトリバー120を収縮させた状態で異物CLを貫通させて、リトリバー120を標的部位よりも遠位に配置する。 Next, as shown in FIG. 8B, the foreign matter removing catheter 50 is sent out from the guiding catheter GC, the foreign matter CL is penetrated in a state where the retriever 120 is contracted, and the retriever 120 is distal to the target site. Place in.

次に、図8(c)に示すように、リトリバー120を拡張させた状態で、異物除去用カテーテル50を手元側に引き寄せ、リトリバー120で異物CLを絡め取る(図8(d)参照。)。リトリバー120に異物CLを絡め取るために、例えば、標的部位においてリトリバー120を管軸中心に回転させてもよいし、標的部位においてリトリバー120を前進/後退させてもよいし、標的部位においてリトリバー120を拡張/収縮してもよい。 Next, as shown in FIG. 8C, with the retriever 120 expanded, the foreign matter removing catheter 50 is pulled toward the hand side, and the foreign matter CL is entangled with the retriever 120 (see FIG. 8D). .. In order to entangle the foreign body CL with the retriever 120, for example, the retriever 120 may be rotated around the tube axis at the target site, the retriever 120 may be advanced / retracted at the target site, or the retriever 120 may be moved forward / backward at the target site. May expand / contract.

そして、図8(e)に示すように、異物CLを絡めたままリトリバー120を収縮させて、リトリバー120(異物除去用カテーテル50)をガイディングカテーテルGC内に引き込む(図8(f)参照。)。その後、ガイディングカテーテルGCの内部から異物除去用カテーテル50を抜き取る作業を行うことにより、経皮的に異物CLを体外に取り出すことができる。 Then, as shown in FIG. 8E, the retriever 120 is contracted while the foreign matter CL is entwined, and the retriever 120 (foreign matter removing catheter 50) is pulled into the guiding catheter GC (see FIG. 8F). ). After that, by removing the foreign matter removing catheter 50 from the inside of the guiding catheter GC, the foreign matter CL can be taken out of the body percutaneously.

以上、説明したように、本実施形態に係る異物除去デバイス100によれば、前述した医療用管状部材10と同様の効果が得られるだけでなく、血管等の管状組織における異物の除去又は回収を要する所定位置へ異物除去デバイス100を円滑に搬送することができる。これにより、管状組織内の異物を容易に除去又は回収することができる。 As described above, the foreign matter removing device 100 according to the present embodiment not only obtains the same effect as the medical tubular member 10 described above, but also removes or recovers foreign matter in a tubular tissue such as a blood vessel. The foreign matter removing device 100 can be smoothly transported to the required predetermined position. Thereby, the foreign matter in the tubular tissue can be easily removed or recovered.

また、本実施形態に係る異物除去用カテーテル50によれば、前述した医療用管状部材10と同様の効果が得られるだけでなく、上述した異物除去デバイス100と略同様に、異物除去デバイス100を円滑に血管等の管状組織における異物の除去又は回収を要する所定位置へ挿入し、管状組織内の異物を容易に除去又は回収することができる。 Further, according to the foreign matter removing catheter 50 according to the present embodiment, not only the same effect as the medical tubular member 10 described above can be obtained, but also the foreign matter removing device 100 can be obtained substantially in the same manner as the foreign matter removing device 100 described above. It can be smoothly inserted into a predetermined position where foreign matter in a tubular tissue such as a blood vessel needs to be removed or recovered, and the foreign matter in the tubular tissue can be easily removed or recovered.

なお、本発明は上記実施形態に例示したものに限定されるものではなく、本発明の要旨を逸脱しない範囲において種々の態様において実施することが可能であり、例えば次のような変形も可能である。 The present invention is not limited to those exemplified in the above embodiments, and can be implemented in various aspects without departing from the gist of the present invention. For example, the following modifications can be made. be.

上記実施形態においては、管状部材10のスリット20が、軸線Xと直交する直線Aに対して僅かに傾いて周方向へ螺旋状に連なるように形成され、周方向へ螺旋状に連なるスリット20どうしの間のスリット間領域部24が螺旋状に配置されている場合を例示して説明したが、本発明はこれに限定されるものではない。
例えば、図9に示すように、スリット20は、軸線X方向へ間隔をあけた複数箇所において、軸線Xと直交する直線Aに沿って周方向に連なるように形成され、周方向へ連なるスリット20どうしの間のスリット間領域部24が軸線X方向において互い違いに配置されていてもよい。この場合も、屈曲の自由度を高め、より円滑に軸線X方向と交わるあらゆる方向へ屈曲させることができる。
In the above embodiment, the slits 20 of the tubular member 10 are formed so as to be spirally connected in the circumferential direction at a slight inclination with respect to the straight line A orthogonal to the axis X, and the slits 20 are spirally connected in the circumferential direction. Although the case where the interslit region portion 24 between the slits is arranged in a spiral shape has been described as an example, the present invention is not limited to this.
For example, as shown in FIG. 9, the slits 20 are formed so as to be continuous in the circumferential direction along a straight line A orthogonal to the axis X at a plurality of locations spaced apart in the axial direction X direction, and the slits 20 are continuous in the circumferential direction. The interslit region portions 24 between the slits may be arranged alternately in the axis X direction. In this case as well, the degree of freedom of bending can be increased, and the bending can be performed more smoothly in any direction intersecting the axis X direction.

なお、複数のスリット20における隣合うものどうしの間隔(繰り返しのピッチ)は、例えば、管状部材10の軸方向の位置によって異ならせてもよい。具体的には、例えば、管状部材10の先端側の部分とその反対側となる基端側の部分とでピッチを異ならせることで可撓性を変化させてもよいし、基端側から先端側にかけて段階的にピッチを異ならせることで先端側ほど屈曲し易くなるようにしてもよい。 The spacing (repeating pitch) between adjacent slits 20 in the plurality of slits 20 may be different depending on, for example, the axial position of the tubular member 10. Specifically, for example, the flexibility may be changed by changing the pitch between the portion on the distal end side of the tubular member 10 and the portion on the proximal end side opposite to the distal end side, or from the proximal end side to the distal end. By gradually changing the pitch toward the side, it may be easier to bend toward the tip side.

また、スリット20の形状としては、例えば、図10に示すように、中央領域20Aにおいて、直線状の縁部22が平行に配置され、両端領域20Bにおいて、中央側から端部へ向かって直線状の縁部22どうしが次第に近接されて幅が次第に狭くされている形状であってもよい。
さらに、スリット20は、その延在方向の両端部側で互いに対向する縁部22における端部へ向かって次第に近接されて幅が狭くされている部分と孔部21とは連続していなくてもよい。例えば、図示は省略するが、縁部22の次第に近接されて幅が狭くされている部分に連続して、幅を一定とした平行部分が形成され、この平行部分に連続して孔部21が形成されていてもよい。
As for the shape of the slit 20, for example, as shown in FIG. 10, in the central region 20A, the linear edge portions 22 are arranged in parallel, and in the both end regions 20B, the slits are linear from the central side to the end portions. The edges 22 of the above may be in a shape in which the edges 22 are gradually brought closer to each other and the width is gradually narrowed.
Further, in the slit 20, even if the hole 21 is not continuous with the portion of the edge 22 facing each other on both ends in the extending direction, which is gradually approached toward the end and narrowed in width. good. For example, although not shown, a parallel portion having a constant width is formed continuously to a portion of the edge portion 22 that is gradually approached and narrowed in width, and a hole portion 21 is continuously formed in the parallel portion. It may be formed.

また、上記実施形態で例示した管状部材10の材料や形状等は、一例であってこれに限られるものではなく、適宜任意に変更可能である。すなわち、管状部材10が金属材料である場合を例示して説明したが、本発明はこれに限定されるものではなく、例えば、樹脂や木材などでもよい。また、管状部材10の断面形状が円形状である場合を例示して説明したが、本発明はこれに限定されるものではなく、例えば、楕円形であってもよいし、多角形であってもよい。 Further, the material, shape, and the like of the tubular member 10 illustrated in the above embodiment are merely examples and are not limited to this, and can be arbitrarily changed as appropriate. That is, the case where the tubular member 10 is made of a metal material has been described as an example, but the present invention is not limited to this, and for example, resin or wood may be used. Further, the case where the cross-sectional shape of the tubular member 10 is circular has been described as an example, but the present invention is not limited to this, and may be, for example, an elliptical shape or a polygonal shape. May be good.

また、上記実施形態においては、スリット20の両端の孔部21が円形状である場合を例示して説明したが、本発明はこれに限定されるものではなく、例えば、楕円形状などであってもよい。 Further, in the above embodiment, the case where the holes 21 at both ends of the slit 20 have a circular shape has been described as an example, but the present invention is not limited to this, and the slit 20 has, for example, an elliptical shape. May be good.

また、上記実施形態においては、管状部材10とリトリバー120とが一体形成されている場合を例示して説明したが、本発明はこれに限定されるものではなく、管状部材10とリトリバー120とをそれぞれ別体として形成したのち、接着や溶接等の手段によって管状部材10とリトリバー120とを接合したものであってもよい。 Further, in the above embodiment, the case where the tubular member 10 and the retriever 120 are integrally formed has been described as an example, but the present invention is not limited to this, and the tubular member 10 and the retriever 120 are used. After forming each as a separate body, the tubular member 10 and the retriever 120 may be joined by means such as adhesion or welding.

また、上記実施形態においては、使用対象となる管状組織が、血管である場合を例示して説明したが、本発明はこれに限定されるものではない。例えば、消化管や胆管等、他の管状組織の内部に挿入される管状部材10、消化管や胆管等、他の管状組織の内部に発生した異物を除去又は回収するための異物除去デバイス100、異物除去用カテーテル50にも、本発明を適用可能である。 Further, in the above embodiment, the case where the tubular tissue to be used is a blood vessel has been illustrated and described, but the present invention is not limited thereto. For example, a tubular member 10 inserted inside another tubular tissue such as a digestive tract or a bile duct, a foreign substance removing device 100 for removing or recovering a foreign substance generated inside another tubular tissue such as the digestive tract or the bile duct. The present invention can also be applied to the foreign matter removing catheter 50.

(評価試験)
螺旋状に連なるようにスリットが配置され、各スリットの端部どうしの間のスリット間領域部が螺旋状に配置された各種の管状部材に対して各種評価試験を行った。
(Evaluation test)
Various evaluation tests were performed on various tubular members in which the slits were arranged so as to be spirally connected and the interslit region between the ends of the slits was arranged spirally.

(1)評価試料
外径1.75mm、内径1.45mmのNi−Ti合金からなるパイプに各種のスリットを形成した下記の実施例1〜3及び比較例1の管状部材を評価した。
実施例1〜3の管状部材には、両端に孔部を有し、延在方向の両端部側で互いに対向する縁部が端部へ向かって次第に近接されて幅が狭くなるスリットが形成されている。孔部の径は、実施例1では0.08mm、実施例2では0.14mm、実施例3では0.20mmである。
比較例1の管状部材には、両端に孔部のないストレートのスリットが形成されている。
(1) Evaluation Sample The tubular members of Examples 1 to 3 and Comparative Example 1 described below in which various slits were formed in a pipe made of a Ni—Ti alloy having an outer diameter of 1.75 mm and an inner diameter of 1.45 mm were evaluated.
The tubular members of Examples 1 to 3 are formed with slits having holes at both ends, and the edges facing each other on both ends in the extending direction are gradually brought closer toward the ends to narrow the width. ing. The diameter of the hole is 0.08 mm in Example 1, 0.14 mm in Example 2, and 0.20 mm in Example 3.
The tubular member of Comparative Example 1 is formed with straight slits having no holes at both ends.

(2)試験内容
(2−1)可撓性試験
管状部材を30mmの間隔で支持し、その中央に荷重を付与して2mm押し込み、その荷重を測定する。測定は各管状部材で3回行い、その平均値を算出する。
(2−2)屈曲試験
屈曲させた管状部材を対向する2枚の平板で挟み、平板間の距離を近づけ、管状部材の破断時における屈曲部分の曲率半径を測定する。測定は各管状部材で3回行い、その平均値を算出する。
(2−3)引張試験
各管状部材を引張試験機によって引張速度10mm/minで引張り、破断するまでの引張強度を測定する。測定は各管状部材で3回行い、その平均値を算出する。
(2) Test contents (2-1) Flexibility test A tubular member is supported at intervals of 30 mm, a load is applied to the center of the tubular member, and the load is pushed in by 2 mm, and the load is measured. The measurement is performed three times for each tubular member, and the average value is calculated.
(2-2) Bending test The bent tubular member is sandwiched between two opposing flat plates, the distance between the flat plates is shortened, and the radius of curvature of the bent portion at the time of breaking of the tubular member is measured. The measurement is performed three times for each tubular member, and the average value is calculated.
(2-3) Tensile test Each tubular member is pulled by a tensile tester at a tensile speed of 10 mm / min, and the tensile strength until fracture is measured. The measurement is performed three times for each tubular member, and the average value is calculated.

(3)評価結果
各評価試験の結果を表1に示す。
(3) Evaluation results Table 1 shows the results of each evaluation test.

Figure 0006937151
Figure 0006937151

(3−1)可撓性試験
各管状部材の押し込み時の平均荷重は、実施例1が1.37N、実施例2が1.14N、実施例3が0.80N、比較例1が1.68Nとなった。このように、スリットの両端に孔部を有する実施例1〜3は、スリットの両端に孔部のない比較例1よりも曲げに要する力が少なく、可撓性が向上することが確認された。また、孔部の径は、大きいほど可撓性の向上に寄与することが確認された。
(3−2)屈曲試験
各管状部材の平均曲率半径は、実施例1が2.08mm、比較例1が3.53mmとなり、実施例2及び実施例3では、破断が生じなかった。このように、スリットの両端に孔部を設けることで、スリットの両端に孔部のない比較例1と比べて、実施例1のように屈曲によって破断する曲率半径が小さくなり、また、実施例2,3のように、孔部の径が0.14mm以上では、屈曲による破断が生じなくなることが確認された。
(3−3)引張試験
各管状部材の平均引張強度は、実施例1が40.9N、実施例2が38.0N、実施例3が27.3N、比較例1が46.7Nとなった。スリットの両端に孔部を有する実施例1〜3は、スリットの両端に孔部のない比較例1に比べ、引張強度は多少低下するものの、十分な引張強度が得られることが確認された。
(3-1) Flexibility test The average load when pushing each tubular member was 1.37N in Example 1, 1.14N in Example 2, 0.80N in Example 3, and 1. It became 68N. As described above, it was confirmed that Examples 1 to 3 having holes at both ends of the slit require less force for bending and improve flexibility as compared with Comparative Example 1 having holes at both ends of the slit. .. It was also confirmed that the larger the diameter of the hole, the more it contributes to the improvement of flexibility.
(3-2) Bending test The average radius of curvature of each tubular member was 2.08 mm in Example 1 and 3.53 mm in Comparative Example 1, and no fracture occurred in Examples 2 and 3. By providing holes at both ends of the slit in this way, the radius of curvature that breaks due to bending becomes smaller as in Example 1 as compared with Comparative Example 1 in which there are no holes at both ends of the slit. It was confirmed that when the diameter of the hole is 0.14 mm or more as in 2 and 3, breakage due to bending does not occur.
(3-3) Tensile Test The average tensile strength of each tubular member was 40.9N in Example 1, 38.0N in Example 2, 27.3N in Example 3, and 46.7N in Comparative Example 1. .. It was confirmed that in Examples 1 to 3 having holes at both ends of the slit, sufficient tensile strength was obtained, although the tensile strength was slightly lower than that of Comparative Example 1 having no holes at both ends of the slit.

上記の評価試験の結果から、管状部材に形成するスリットの両端に、0.08mm以上0.20mm以下の径の孔部を設けることで、スリットにおける破断や変形を抑制しつつ可撓性の向上が図れることが確認でき、特に、径が0.14mmの孔部をスリットの両端に設けることで、管状部材のスリットにおける破断や変形の抑制効果及び可撓性の向上がより高められることが確認できた。 Based on the results of the above evaluation test, by providing holes with a diameter of 0.08 mm or more and 0.20 mm or less at both ends of the slit formed in the tubular member, flexibility is improved while suppressing breakage and deformation in the slit. In particular, it was confirmed that by providing holes with a diameter of 0.14 mm at both ends of the slit, the effect of suppressing breakage and deformation in the slit of the tubular member and the improvement of flexibility can be further enhanced. did it.

10:医療用管状部材
11:管壁
20:スリット
21:孔部
22:縁部
24:スリット間領域部
50:異物除去用カテーテル
60:カテーテル本体
70:操作部
100:異物除去デバイス
120:リトリバー(被挿入部材)
B:直線
CL:異物
X:軸線

10: Medical tubular member 11: Tube wall 20: Slit 21: Hole 22: Edge 24: Interslit region 50: Foreign matter removing catheter 60: Catheter body 70: Operating unit 100: Foreign matter removing device 120: Retriever ( Inserted member)
B: Straight line CL: Foreign matter X: Axis

Claims (6)

管状組織に挿入される筒状の医療用管状部材であって、
前記管状組織に挿入され、軸線方向に略直交する径方向に拡縮可能な被挿入部材の挿入方向前方側及び挿入方向後方側のうち、少なくとも一方に一体形成され、
当該医療用管状部材の管壁を貫通し、軸線方向と斜めに交わる方向に沿う複数のスリットが形成され、
前記複数のスリットの各々は、
互いに対向する縁部が、前記スリットの延在方向の両端部へ向かって次第に近接されて幅が狭くされ、
前記両端部が丸孔形状をなすように膨らんでなることを特徴とする医療用管状部材。
A tubular medical tubular member that is inserted into a tubular tissue.
The inserted member inserted into the tubular tissue and expandable and contractible in the radial direction substantially orthogonal to the axial direction is integrally formed on at least one of the front side in the insertion direction and the rear side in the insertion direction.
A plurality of slits are formed through the tube wall of the medical tubular member and along the direction diagonally intersecting the axial direction.
Each of the plurality of slits
The edges facing each other are gradually brought closer to each other toward both ends in the extending direction of the slit, and the width is narrowed.
A medical tubular member characterized in that both ends thereof bulge so as to form a round hole.
周方向のいずれの位置においても、軸線方向と略平行な直線上に前記スリットが存在することを特徴とする請求項1に記載の医療用管状部材。 The medical tubular member according to claim 1, wherein the slit exists on a straight line substantially parallel to the axial direction at any position in the circumferential direction. 前記複数のスリットは、周方向へ螺旋状に連なるように配置されている
ことを特徴とする請求項1または請求項2に記載の医療用管状部材。
The medical tubular member according to claim 1 or 2, wherein the plurality of slits are arranged so as to be spirally connected in the circumferential direction.
前記複数のスリットは、軸線方向に隣合うものどうしが周方向にずれて配置されていることを特徴とする請求項1または請求項2に記載の医療用管状部材。 The medical tubular member according to claim 1 or 2, wherein the plurality of slits are arranged so as to be adjacent to each other in the axial direction so as to be displaced in the circumferential direction. 管状組織内の異物を除去又は回収可能に構成されている異物除去デバイスであって、
前記管状組織に挿入され、軸線方向に略直交する径方向に拡縮可能な被挿入部材と、
前記被挿入部材の挿入方向前方側及び挿入方向後方側のうち、少なくとも一方に一体形成され、前記管状組織に挿入される筒状の管状部材と、を備え、
前記管状部材には、その管壁を貫通し、軸線方向と斜めに交わる方向に沿う複数のスリットが形成され、
前記複数のスリットの各々は、
互いに対向する縁部が、前記スリットの延在方向の両端部へ向かって次第に近接されて幅が狭くされ、
前記両端部が丸孔形状をなすように膨らんでなることを特徴とする異物除去デバイス。
A foreign matter removing device configured to remove or recover foreign matter in a tubular tissue.
A member to be inserted that is inserted into the tubular tissue and can be expanded or contracted in the radial direction substantially orthogonal to the axial direction.
Wherein among the insertion direction front side and the insertion direction rear side of the insertion member is formed integrally on at least one, and a cylindrical tubular member which is inserted into the tubular tissue,
The tubular member is formed with a plurality of slits penetrating the tube wall and along a direction diagonally intersecting the axial direction.
Each of the plurality of slits
The edges facing each other are gradually brought closer to each other toward both ends in the extending direction of the slit, and the width is narrowed.
A foreign matter removing device characterized in that both ends are bulged so as to form a round hole shape.
管状組織内の異物を除去又は回収するための異物除去用カテーテルであって、
カテーテル本体と、
前記カテーテル本体の遠位部に配置され、前記管状組織内の異物を除去又は回収可能に構成されている異物除去デバイスと、を備え、
前記異物除去デバイスは、
前記管状組織に挿入され、軸線方向に略直交する径方向に拡縮可能な被挿入部材と、
前記被挿入部材の挿入方向前方側及び挿入方向後方側のうち、少なくとも一方に一体形成され、前記管状組織に挿入される筒状の管状部材と、を備え、
前記管状部材には、その管壁を貫通し、軸線方向と斜めに交わる方向に沿う複数のスリットが形成され、
前記複数のスリットの各々は、
互いに対向する縁部が、前記スリットの延在方向の両端部へ向かって次第に近接されて幅が狭くされ、
前記両端部が丸孔形状をなすように膨らんでなることを特徴とする異物除去用カテーテル。
A foreign matter removal catheter for removing or recovering foreign matter in a tubular tissue.
Catheter body and
A foreign body removing device located at the distal portion of the catheter body and configured to remove or recover foreign body in the tubular tissue.
The foreign matter removing device is
A member to be inserted that is inserted into the tubular tissue and can be expanded or contracted in the radial direction substantially orthogonal to the axial direction.
Wherein among the insertion direction front side and the insertion direction rear side of the insertion member is formed integrally on at least one, and a cylindrical tubular member which is inserted into the tubular tissue,
The tubular member is formed with a plurality of slits penetrating the tube wall and along a direction diagonally intersecting the axial direction.
Each of the plurality of slits
The edges facing each other are gradually brought closer to each other toward both ends in the extending direction of the slit, and the width is narrowed.
A foreign matter removing catheter characterized in that both ends are bulged so as to form a round hole shape.
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US10285720B2 (en) 2014-03-11 2019-05-14 Neuravi Limited Clot retrieval system for removing occlusive clot from a blood vessel
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AU2020328574B2 (en) * 2019-08-14 2025-08-14 Lsi Solutions, Inc. Device for vessel harvesting
US11478609B2 (en) * 2019-09-26 2022-10-25 Biosense Webster (Israel) Ltd. Bendable guidewire
US12539130B2 (en) 2019-11-27 2026-02-03 Neuravi Limited Aspiration catheter, systems, and methods thereof
US11759217B2 (en) 2020-04-07 2023-09-19 Neuravi Limited Catheter tubular support
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