JP4369546B2 - Catheter introducer - Google Patents

Description

【００３０】
このように構成される本発明のカテーテルイントロデューサＡは、先端の尖ったダイレーター６をシースチューブ１内に挿着し、細管先端の円錐状部６ａを頭出させた同シースチューブ１を、皮膚Ｓから動脈等の血管Ｂ（図５参照）に突き刺し、次いで、ダイレーター６を抜き外してシースチューブ１を血管内に挿入した状態で留置し、カテーテル（図示せず）を挿入して患部の閉塞摘除、造影等の医療行為に及ぶものである。
【００３１】
而して、斯かる手技（橈骨動脈等への穿刺とシース挿入）の初期や途中で、血管Ｂが所謂、放射痙攣（radial spasm）を起こした場合には、図５に示すように、前記カテーテルに代えて再度ダイレーター６をシースチューブ１内に挿着し、ヘパリンライン３の三方活栓４を開弁して注射器７を接続することにより、血管拡張剤等の薬液を注入する。
【００３２】
その際、斯かる薬液は、シースチューブ１の先端開口が前記大径部６ｂで略閉塞されているため、先端方向には僅に流れ出るものの、一旦、両部材間のクリアランス内に圧入される結果、その圧力でシースチューブ１のスリット１ａ，１ａ…から勢い良く径方向に噴出（拡散放射）して血管の内皮に効率良く届くため、即効的に放射痙攣を解除することができる。
【００３３】
従って、従来より常套的に使用されていた薬用放出用及び抜去用の２種類のオプチュレータ（図示せず）が不要になるものであり、また、この（スリット式）シースチューブ１にあっては、円形の側孔シースに比して血管内壁が食い込む心配がなく、また、表面の段差抵抗も感じられないため、換言すれば、穿刺・抜去時における抵抗が皆無となるため、最も確実にかつ安全にシースチューブ１を抜去することができる。
【００３４】
因に、ダイレーター６の先端大径部６ｂの大きさ（外径）如何で、シースチューブ１の先端開口のシール性（水密度）が異なるため、換言すれば、シースチューブ１の内周面に水密にも粗密にも接合できるため、同シースチューブ１の先端開口からの薬液流出を完全に阻止したり、僅かな流出量に抑えることができるなど、使用目的に応じて先端方向への流量調整ができることは云うまでもない。
【００３５】
尚、本発明は本実施例に限定されることなく、本発明の目的の範囲内で自由に設計変更し得るものであり、本発明はそれらの全てを包摂するものである。例えば、シースチューブ１及びダイレーター６の形状、大きさ、長さ、スリット位置等は本実施例に限定されるものではい。
【００３６】
また、薬液の逆流を有効的に防止するために、ダイレーター６の先端側のみならず、中間にも大径部（図示せず）を突設しても良い。しかも、斯かる中間大径部の取付位置（高さ）の異なる多種類のダイレーター６を予め用意しておけば、シースチューブ１内に挿着した際に、中間大径部の位置（高さ）がそれぞれに異なることから、同シースチューブ１のスリット１ａ，１ａ…との連通（孔数）を規制できるため（同一のシースチューブを使用しながらも）、任意的に必要部分以外の薬液投与を阻止したり、薬液の噴出圧をも調整可能となる。
【００３７】
更に、ダイレーターの周面に螺旋状等の凹溝（図示せず）を設ければ、シースチューブ１内に挿着した際、互いのクリアランス（間隙）なく密着する場合であっても、ヘパリンライン３よりシースチューブ１内に注入された薬液は、斯かる螺旋状の凹溝を介してシースチューブ１の各スリット１ａ，１ａ…に連通し、径方向へと噴出することができる。
【００３８】
また、前記スリット１ａ，１ａを、シースチューブ１の表面に凹部（図示せず）を介して形成すれば、手技の途中で痙攣が起きた場合、例えば、橈骨動脈等の血管がシースチューブ１を締め付けた状態にあっても、スリット１ａ，１ａ…が前記凹部により囲繞されるため、換言すれば、血管内皮との密着を避けるべく凹部によりクリアランスが確保されてスリット１ａ，１ａ…を閉塞させることがないため、血管拡張剤等の薬液を血管の内皮に確実に放出することができる結果、即効的に血管攣縮を解除することができ、シースチューブ１を安全に抜去することができるのである。
【００３９】
【発明の効果】
本発明は上述のように構成され、前記シースチューブの表面に、周方向に等間隔でスパイラル状に複数のスリットを有すると共に、血管拡張用のダイレーターを内挿し、前記ヘパリンラインより血管拡張剤等の薬液を注入することによって、スリット孔内に血管内壁が食い込んでしまう心配がなく、穿刺・抜去時の抵抗値を更に低下せしめることができると共に、ヘパリンラインより注入される薬液が、シースチューブとダイレーターとの間の狭いクリアランス内に圧入し、その圧力（水圧）を利用してシースチューブの各スリットより均等かつ勢い良く噴出（拡散放射）できるといった効果を奏するものであり、従来、使用していた薬液放出用及び抜去用の二種類のオプチュレータが不要になる。
【００４０】
また、前記スリットが、長さ０．１ミリ〜５０ミリ、深さはシースチューブの肉厚と略等しくすることにより、通常の血圧よりも高い、ある一定圧でのみ弁として働くため、シースチューブ内への血液の侵入を阻止できるといった効果を奏するものである。
【００４１】
更に、前記スリットが、シースチューブの長手方向を基本とし、必要に応じて所定方向に角度をつければ、シースチューブの可撓性を損なうことのないように穿設できるため、スリットに起因する意に反した安易な折れ曲がりを防止できるといった効果を奏する。
【００４２】
また、前記スリットをシースチューブの表面に凹部を介して形成すれば、血管攣縮時にあっても、血管内皮との間に薬液を流出するのに必要な空隙（クリアランス）を確保できるため、各スリットから血管拡張剤等の薬液を血管内皮に確実に放出することができ、即効的に血管攣縮を解除することができるといった効果を奏するものであり、また、血管攣縮時におけるシースチューブと血管との間の摩擦を減滅できることも相俟って、シースチューブの抜去操作をより安全かつスムースに行うことができるといった効果を奏するものである。
【００４３】
更に、前記ダイレーターは、外径がシースチューブの内径よりも小さく形成されると共に、所定位置にシースチューブの内周面に接合する大径部を設けてなることによって、シースチューブの先端開口からの一方的な薬液の流出を阻止し、スリットからの噴出を助長できるといった効果を奏するものである。
【００４４】
このように本発明は、シースチューブの側孔に血管内壁が食い込んでしまう心配がなく、穿刺・抜去時の抵抗値を更に低下せしめ、ヘパリンラインから注入される血管拡張剤等の薬液を効率良く同シースチューブのスリットから均等かつ確実に噴出させることができ、仮令、手技の途中で血管攣縮が起きたとしても、即効的に解除させてシースチューブを安全に抜去することができるものであり、また、構成が単純であるため、大量生産に適し、価格も低廉なものとして需要者に供給できる等、本発明を実施することはその実益的価値が甚だ大である。
【図面の簡単な説明】
【図１】ダイレーターを挿着した状態を示す本発明に係るカテーテルイントロデューサの正面図である。
【図２】ダイレーターの未挿着状態を示す同カテーテルイントロデューサの正面図である。
【図３】シースチューブのスリット位置を示す説明図である。
【図４】本実施例で使用するダイレーターの正面図である。
【図５】本発明に係るカテーテルイントロデューサによるスパズム解除イメージを示す説明図である。
【符号の説明】
Ａ カテーテルイントロデューサ
Ｂ 血管
Ｓ 皮膚
１ シースチューブ
１ａ スリット
２ シース本体
２ａ プロテクター
２ｂ 接手管（チューブ止め）
２ｃ 上キャップ
２ｄ 突起
３ ヘパリンライン
４ 三方活栓
５ ダイレーター基
５ａ ルアコネクター
５ｂ 突起
６ ダイレーター
６ａ 円錐状部
６ｂ 大径部
７ 注射器[0001]
BACKGROUND OF THE INVENTION
The present invention relates to an improvement of a catheter introducer in which a sheath tube is introduced into a blood vessel in advance in order to insert the catheter into the blood vessel. More specifically, the resistance value at the time of puncture / extraction is low, and (conventional optolator) A catheter introducer capable of efficiently ejecting a liquid medicine such as a vasodilator injected from a heparin line from a slit of a sheath tube (without using any).
[0002]
[Prior art]
Conventionally, as such a catheter introducer, for example, one disclosed in Japanese Patent No. 2510886 is known. This conventional catheter introducer includes a hollow sheath tube that can be introduced into a blood vessel and has a distal end opened, and a sheath body (base) that communicates with the hollow portion of the sheath tube and has a valved conduit. A plurality of side holes are provided on the peripheral surface of the sheath tube.
[0003]
[Problems to be solved by the invention]
However, in the catheter introducer disclosed in the above-mentioned Japanese Patent No. 2510886, since the side hole of the sheath tube is formed in a circle or an ellipse, the inner wall of the blood vessel may bite into the hole. In addition, this may increase the resistance at the time of removal, causing radial spasm, or by forcibly withdrawing the sheath tube, There are also concerns about the worst conditions such as dissociation and further causing internal hemorrhage (arterial hemorrhage) due to vascular rupture.
[0004]
In addition, this conventional catheter introducer has a problem that arterial blood will be ejected from the side hole of the sheath tube unless an extraction optolator is used. ) Has to be infused with a chemical solution.
[0005]
The present invention has been made in view of such a conventional problem, and there is no fear that the inner wall of the blood vessel bites into the slit hole, and the resistance value at the time of puncture / extraction is further reduced and injected from the heparin line. It is an object of the present invention to provide a useful catheter introducer that can efficiently and reliably eject a drug solution such as a vasodilator from a slit of a sheath tube.
[0006]
[Means for Solving the Problems]
The present invention has been made in view of the conventional problems as described above. In a catheter introducer comprising a sheath tube having a desired length and a heparin line communicated with the sheath tube, the surface of the sheath tube is provided. In addition, a plurality of slits are provided in a spiral shape at equal intervals in the circumferential direction, and a vasodilator dilator is inserted into the sheath tube, and a drug solution such as a vasodilator injected from the heparin line is ejected from the slit. In order to achieve this, the dilator includes a conical portion having an outer diameter smaller than the inner diameter of the sheath tube and a thin tip, and is joined to the inner peripheral surface of the sheath tube. the large diameter portion for substantially closing the distal opening of the sheath tube Te provided, the slit has to flow out the liquid medicine between the vascular endothelium To ensure the air gap necessary for, and is characterized in that it is formed through a recess in the surface of the sheath tube.
[0007]
The slit is preferably 0.1 to 50 mm in length and the depth is substantially equal to the thickness of the sheath tube.
[0008]
Furthermore, the slit may be basically formed in the longitudinal direction of the sheath tube, and may be formed in an angle in a predetermined direction as necessary, or may be formed on the surface of the sheath tube via a recess.
[0010]
In the catheter introducer of the present invention configured as described above, the sheath tube has a plurality of slits in the circumferential direction at equal intervals and in a spiral shape, and a dilator for vasodilation is inserted. In addition, there is no worry that the inner wall of the blood vessel will bite into the slit, and the resistance value at the time of puncture / extraction will be further reduced, and the chemical injected from the heparin line will be pressed into the narrow clearance between the sheath tube and the dilator Then, the pressure (water pressure) is used to eject the slits of the sheath tube uniformly and vigorously (uniformly).
[0011]
In addition, the slit has a length of 0.1 mm to 50 mm and a depth substantially equal to the thickness of the sheath tube, so that it functions as a valve only at a certain pressure higher than the normal blood pressure. The blood can be prevented from entering.
[0012]
Furthermore, if the slit is based on the longitudinal direction of the sheath tube and is angled in a predetermined direction as necessary, the slit can be drilled so as not to impair the flexibility of the sheath tube.
[0013]
In addition, if the slit is formed on the surface of the sheath tube via a recess, a gap (clearance) necessary for the drug solution to flow out from the vascular endothelium can be secured even during vasospasm, and the blood vessel Friction between the sheath tube and the blood vessel during spasm can be further reduced.
[0015]
DETAILED DESCRIPTION OF THE INVENTION
Next, an example of implementation of the catheter introducer according to the present invention will be described with reference to the drawings. In the drawing, A is a catheter introducer according to the present invention, and this catheter introducer A is attached to a hollow sheath tube 1 and a proximal end side of the sheath tube 1 as shown in FIG. 1 or FIG. A sheath body 2 and a heparin line 3 projecting from a side surface of the sheath body 2.
[0016]
The sheath tube 1 is made of an appropriate synthetic resin material such as fluororesin or polyurethane, and slits 1a, 1a,. The sheath tube 1 is of a length appropriate for the location of use or treatment purpose (for example, an effective length of about 16 to 18 cm).
[0017]
The sheath tube 1 is preferably a so-called side hole sheath (SH sheath). For example, as shown in FIG. 2, there is a sheath tube formed by drilling 10 to 15 slits 1a, 1a,.
[0018]
The slits 1a, 1a,... Are fine slit holes having a length of 0.1 to 50 mm (preferably 2 to 5 mm or less), a depth of 0.11 to 0.15 mm, and a width (closer to 0). 3 and is perforated in a spiral shape so as to open at intervals of 120 degrees in the circumferential direction at intervals of 10 mm from the tip and as shown in FIG.
[0019]
Moreover, it is preferable to apply a silicone coating or a hydrophilic coating to the surface of the sheath tube 1 as necessary (for example, in the case of a sheath tube made of polyurethane resin).
[0020]
Cover and reduce the frictional force between the sheath tube 1 and the vascular endothelium during vasospasm, so that the removal operation of the sheath tube 1 can be made smoother. As a result, the incidence of radial spasm This is because it can be lowered.
[0021]
On the other hand, the sheath body 2 has a short cylindrical shape, and as shown in FIG. 2, an annular protector 2a for communicating and holding the sheath tube 1 and an annular joint tube (for connecting and holding a heparin line 3 described later) A tube stopper) 2b, and a valve hole (not shown) formed in the rear end surface (top surface) of the sheath body 2 through an on-off valve so as to communicate with the dilator base 5.
[0022]
The sheath tube 1, the joint tube (tube stopper) 2b, and the valve hole are in communication with each other. In other words, a chemical injected from the heparin line 3 to be described later does not leak into the sheath tube 1 without leakage. It is connected so that it may flow in.
[0023]
The heparin line 3 is made of, for example, a synthetic resin tube having a length of 175 to 185 (preferably 180) mm and an outer diameter of 2.52 mm, and a conventional three-way stopcock (three-way switching valve) 4 is mounted on the free end side. Has been.
[0024]
Further, a dilator base 5 formed by connecting and supporting a dilator for blood vessel expansion described later is detachably screwed onto the top surface side of the sheath body 2 (see FIG. 1). The dilator base 5 is formed in a large-diameter lid shape in which a female helix is engraved on the inside so that it can be screwed onto the sheath body 2.
[0025]
Further, an annular luer connector 5a is projected from the top surface of the dilator base 5 as shown in FIG. The luer connector 5a is provided with a communication path (not shown) in a concentric direction so as to communicate with the upper end of the dilator 6, and is closed by a cap (not shown) when not needed.
[0026]
The dilator base 5 and the cap have a spiral groove (not shown) formed on the inner peripheral surface on the lower end opening side of each of the protrusions 2d, which protrude from the outer peripheral surfaces of the sheath body 2 and the luer connector 5a. By screwing 2d (see FIG. 2), 5b, and 5b (see FIG. 4), it is possible to easily and firmly connect each other.
[0027]
On the other hand, as shown in FIG. 4, the dilator 6 is formed of a synthetic resin hollow thin tube having a conical portion 6 a with a thin tip, and its outer diameter is smaller than the inner diameter of the sheath tube 1. In addition, a large-diameter portion 6b that is joined to the inner peripheral surface of the sheath tube 1 in a watertight manner or a coarsely dense manner projects from the distal end side.
[0028]
For example, the inner diameter of the sheath tube 1 differs depending on the French size. For example, as shown in Table 1 below, when the effective length is 170 mm, 1.40 mm (4 Fr), 1.70 mm. (5Fr) and 2.04mm (6Fr) are preferably used, and the outer diameter of the dilator 6 suitable for this size is 1.29mm, 1.55mm and 1.89mm, respectively. (Clearance: 0.11 mm, 0.15 mm, 0.15 mm).
[0029]
[Table 1]

[0030]
The catheter introducer A of the present invention configured as described above includes the sheath tube 1 in which the dilator 6 having a sharp tip is inserted into the sheath tube 1 and the conical portion 6a at the tip of the thin tube is cued. The blood vessel B (see FIG. 5) such as an artery is pierced from the skin S, then the dilator 6 is removed, the sheath tube 1 is inserted into the blood vessel, and the catheter is inserted (not shown) to insert the affected part. It covers medical practices such as occlusion and contrast enhancement.
[0031]
Thus, when blood vessel B causes a so-called radial spasm in the initial stage or in the middle of such a procedure (puncture to radial artery and sheath insertion), as shown in FIG. Instead of the catheter, the dilator 6 is inserted into the sheath tube 1 again, the three-way cock 4 of the heparin line 3 is opened, and the syringe 7 is connected to inject a drug solution such as a vasodilator.
[0032]
At that time, such a chemical solution flows out slightly in the distal direction because the distal end opening of the sheath tube 1 is substantially closed by the large-diameter portion 6b, but is temporarily pressed into the clearance between the two members. .., And radiant convulsions can be immediately and effectively released because the pressure is vigorously ejected (diffused radiation) from the slits 1a, 1a...
[0033]
Therefore, two types of optolators (not shown) for medicinal release and extraction, which have been conventionally used conventionally, become unnecessary, and in this (slit type) sheath tube 1, Compared to a circular side-hole sheath, there is no risk of the inner wall of the blood vessel biting, and there is no surface step resistance, so in other words, there is no resistance at the time of puncture and removal, so it is the most reliable and safe. The sheath tube 1 can be removed.
[0034]
Incidentally, since the sealing property (water density) of the distal end opening of the sheath tube 1 differs depending on the size (outer diameter) of the distal end large diameter portion 6b of the dilator 6, in other words, the inner peripheral surface of the sheath tube 1 Since it can be joined to both the watertight and the coarsely, the flow of the chemical solution from the opening of the sheath tube 1 can be completely prevented, or the flow rate in the distal direction can be reduced depending on the purpose of use. It goes without saying that adjustments can be made.
[0035]
In addition, this invention is not limited to a present Example, It can change freely in the range of the objective of this invention, and this invention includes all of them. For example, the shape, size, length, slit position and the like of the sheath tube 1 and the dilator 6 are not limited to the present embodiment.
[0036]
Further, in order to effectively prevent the backflow of the chemical solution, a large-diameter portion (not shown) may be provided not only on the tip side of the dilator 6 but also in the middle. In addition, if various types of dilators 6 having different attachment positions (heights) of the intermediate large diameter portion are prepared in advance, the position (high height) of the intermediate large diameter portion when inserted into the sheath tube 1 is prepared. ) Are different from each other, so that the communication (number of holes) with the slits 1a, 1a... Of the sheath tube 1 can be regulated (even though the same sheath tube is used). It is possible to prevent administration and adjust the ejection pressure of the chemical solution.
[0037]
Further, if a spiral groove or the like groove (not shown) is provided on the peripheral surface of the dilator, heparin even when closely attached without mutual clearance (gap) when inserted into the sheath tube 1. The chemical solution injected from the line 3 into the sheath tube 1 communicates with the slits 1a, 1a,... Of the sheath tube 1 through the spiral concave groove and can be ejected in the radial direction.
[0038]
In addition, if the slits 1a and 1a are formed on the surface of the sheath tube 1 via a recess (not shown), when a convulsion occurs during the procedure, for example, a blood vessel such as a radial artery causes the sheath tube 1 to Even in the tightened state, the slits 1a, 1a,... Are surrounded by the recesses. In other words, a clearance is secured by the recesses to avoid close contact with the vascular endothelium, and the slits 1a, 1a,. As a result, the chemical solution such as a vasodilator can be surely released to the endothelium of the blood vessel, so that the vasospasm can be released immediately and the sheath tube 1 can be safely removed.
[0039]
【The invention's effect】
The present invention is configured as described above, and has a plurality of slits spirally formed on the surface of the sheath tube at equal intervals in the circumferential direction, and a dilator for vasodilation is inserted, and a vasodilator from the heparin line By injecting a chemical solution such as the above, there is no concern that the inner wall of the blood vessel will bite into the slit hole, and the resistance value at the time of puncture / extraction can be further reduced, and the chemical solution injected from the heparin line is a sheath tube It has the effect that it can be injected into the narrow clearance between the tube and the dilator and can be ejected (diffuse radiation) evenly and vigorously from each slit of the sheath tube using the pressure (water pressure). The two types of optolators for discharging the chemical solution and for removing it are no longer necessary.
[0040]
In addition, since the slit is 0.1 mm to 50 mm in length and the depth is substantially equal to the thickness of the sheath tube, the slit acts as a valve only at a certain constant pressure higher than normal blood pressure. This has the effect of preventing blood from entering the inside.
[0041]
Furthermore, if the slit is based on the longitudinal direction of the sheath tube and is angled in a predetermined direction as necessary, the slit can be drilled so as not to impair the flexibility of the sheath tube. It has an effect that it can prevent easy bending contrary to the above.
[0042]
In addition, if the slit is formed on the surface of the sheath tube through a recess, a gap (clearance) necessary for the drug solution to flow out from the vascular endothelium can be ensured even during vasospasm. It is possible to reliably release a chemical solution such as a vasodilator to the vascular endothelium, and to immediately release vasospasm. In addition, between the sheath tube and the blood vessel during vasospasm Combined with the fact that the friction between them can be reduced, there is an effect that the operation of removing the sheath tube can be performed more safely and smoothly.
[0043]
Furthermore, the dilator is formed with an outer diameter smaller than the inner diameter of the sheath tube, and a large-diameter portion that is joined to the inner peripheral surface of the sheath tube at a predetermined position, so that the distal end of the sheath tube is opened. This prevents the unilateral chemical liquid from flowing out and promotes the ejection from the slit.
[0044]
As described above, the present invention eliminates the concern that the inner wall of the blood vessel bites into the side hole of the sheath tube, further lowers the resistance value at the time of puncture / removal, and efficiently supplies a drug solution such as a vasodilator injected from the heparin line. It can be ejected evenly and reliably from the slit of the sheath tube, and even if vasospasm occurs in the middle of the procedure, the sheath tube can be safely removed by releasing it immediately. In addition, since the configuration is simple, it is suitable for mass production and can be supplied to the consumer with a low price, so that the present invention has a great practical value.
[Brief description of the drawings]
FIG. 1 is a front view of a catheter introducer according to the present invention showing a state in which a dilator is inserted.
FIG. 2 is a front view of the catheter introducer showing a state where the dilator is not inserted.
FIG. 3 is an explanatory view showing a slit position of a sheath tube.
FIG. 4 is a front view of a dilator used in the present embodiment.
FIG. 5 is an explanatory view showing an image of releasing spasm by a catheter introducer according to the present invention.
[Explanation of symbols]
A catheter introducer B blood vessel S skin 1 sheath tube 1a slit 2 sheath body 2a protector 2b joint tube (tube stop)
2c Upper cap 2d Protrusion 3 Heparin line 4 Three-way cock 5 Dilator base 5a Luer connector 5b Protrusion 6 Dilator 6a Conical part 6b Large diameter part 7 Syringe

Claims (3)

In a catheter introducer comprising a sheath tube of a desired length and a heparin line communicated with the sheath tube, the surface of the sheath tube is provided with a plurality of slits at equal intervals in the circumferential direction and spirally, In order to eject a liquid medicine such as a vasodilator injected from the heparin line by inserting a dilator for vasodilation into the sheath tube, the dilator has an outer diameter larger than the inner diameter of the sheath tube. A conical portion having a small tip and a thin tip is provided, and a large-diameter portion is provided in the conical portion so as to join the inner peripheral surface of the sheath tube and substantially close the opening of the sheath tube. The surface of the sheath tube is used to secure a gap necessary for the drug solution to flow between the slit and the vascular endothelium. Catheter introducer, characterized in that it is formed through a recess.   The catheter introducer according to claim 1, wherein the slit has a length of 0.1 mm to 50 mm and a depth substantially equal to a thickness of the sheath tube.   The catheter introducer according to claim 1 or 2, wherein the slit is formed with an angle in a predetermined direction as required based on the longitudinal direction of the sheath tube.

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