WO2007080843A1 - Catheter system - Google Patents

Catheter system Download PDF

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Publication number
WO2007080843A1
WO2007080843A1 PCT/JP2007/050063 JP2007050063W WO2007080843A1 WO 2007080843 A1 WO2007080843 A1 WO 2007080843A1 JP 2007050063 W JP2007050063 W JP 2007050063W WO 2007080843 A1 WO2007080843 A1 WO 2007080843A1
Authority
WO
WIPO (PCT)
Prior art keywords
adapter
catheter
balloon
seal
fluid
Prior art date
Application number
PCT/JP2007/050063
Other languages
French (fr)
Japanese (ja)
Inventor
Kohei Fukaya
Hitoshi Tahara
Original Assignee
Kaneka Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Kaneka Corporation filed Critical Kaneka Corporation
Priority to JP2007553895A priority Critical patent/JP5067164B2/en
Publication of WO2007080843A1 publication Critical patent/WO2007080843A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/12—Tube connectors; Tube couplings for joining a flexible tube to a rigid attachment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1025—Connections between catheter tubes and inflation tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M2025/0042—Microcatheters, cannula or the like having outside diameters around 1 mm or less
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1027—Quick-acting type connectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1077—Adapters, e.g. couplings adapting a connector to one or several other connectors

Definitions

  • the present invention relates to a catheter system having a balloon which is introduced into the body percutaneously and transluminally to close the lumen of the body or to remove foreign substances from the thrombus.
  • angioplasty is performed to improve the blood flow on the peripheral side of the blood vessel by expanding the stenosis or occlusion site of the blood vessel.
  • Percutaneous Transluminal Angioplasty ⁇ PTCA Percutaneous Translumina 1 Coronary Angioplasty, etc.
  • stents and the like for maintaining the state of the expanded stenosis have been used in recent years.
  • Balloon catheters used for PTA and PTCA are mainly used as a set of a guide catheter and a guide wire in order to expand a stenosis site or a blockage site of a blood vessel.
  • a guide catheter is first inserted from the femoral artery, the tip is positioned at the entrance of the coronary artery via the aorta, and then a guide wire penetrating the balloon catheter is inserted into the blood vessel.
  • This balloon catheter is not limited to the treatment of stenosis or occlusion in blood vessels, but is useful for many medical applications including insertion into blood vessels and insertion into various body cavities and tubular tissues.
  • the blood clot may be released from the inner wall of the blood vessel and occlude the downstream peripheral blood vessel.
  • a stenotic site in a blood vessel is expanded, if the lesion contains a large number of rod-like plaques, expansion by a balloon catheter causes a plaque-like plaque (character) from the lesion. (ROHM) may scatter and obstruct peripheral blood vessels.
  • ROHM plaque-like plaque
  • vasodilators may be administered to restore blood flow, or drugs such as thrombolytic agents may be administered locally to dissolve obstructions. Sometimes it does not reach. If peripheral occlusion is severe and hemodynamics are poor, auxiliary means such as IABP are also used.
  • a temporary occlusion balloon catheter since the occlusion state can be confirmed on contrast, it may be actively used for lesions that require reliable occlusion.
  • the problem with temporary occlusion balloon catheters is that blood flow does not flow to the periphery during occlusion for protection, and the periphery can easily become temporarily ischemic, which can have adverse effects.
  • temporary occlusion balloon catheters expand the balloon at the periphery of the lesion, This problem is exacerbated by the need to insert and remove other force tapers along the shaft of the temporary occlusion balloon catheter while maintaining its expansion, which is more complicated than the filter device. Easy to come out.
  • Patent Document 1 discloses a catheter for blocking blood flow using a single inflation balloon and an adapter for inflating or deflating an inflation balloon. It is only described that the adapter in the prior art is detachable from the proximal end portion of the catheter, and the adapter is also provided with a function for operating the extension member (the moving part in the present invention) in the prior art. Not. In such a case, it is considered that it is quite difficult to directly operate the thin shaft with the hand, which seems to be directly operated by the operator's hand.
  • Patent Document 2 discloses a catheter having a rope mouth file valve and an inflation adapter for operating the valve.
  • the adapter in this prior art is a housing force having a first part and a second part, which secures the catheter in the housing and aligns the first part and the second part with a locking clip and nosing.
  • Patent Document 1 Japanese Unexamined Patent Application Publication No. 2002-126093
  • Patent Document 2 Japanese Patent Publication No. 2000-511082
  • the present invention is to provide a catheter system that is very simple and quick to operate.
  • Means for solving the above problems include an adapter for introducing and discharging a fluid necessary for the expansion and contraction operation of the catheter body and the balloon depending on the structure of the catheter system having a new balloon and the selected material arrangement.
  • the purpose of the present invention is to provide a catheter system in which the procedure required for the operation is reduced by improving the connectivity (simpleness of operation).
  • a balloon a tubular body having an inflation lumen through which a fluid for expanding or contracting the balloon can move, a catheter body having a fluid seal portion that seals the fluid at a proximal portion of the tubular body, and a catheter body
  • the adapter system is connected to the catheter, and the seal is opened by inserting and inserting the seal portion of the catheter body into the adapter, and the seal is closed by removing the adapter force from the adapter. Since the catheter system is characterized in that the catheter body can be connected to and detached from the adapter and the catheter body can be opened and closed with a minimum operation procedure, the problem of the present invention can be solved.
  • the invention's effect is characterized in that the catheter body can be connected to and detached from the adapter and the catheter body can be opened and closed with a minimum operation procedure.
  • the present invention relates to inflation in which a balloon and a fluid for expanding or contracting the balloon are movable.
  • a tubular body having a lumen; a catheter body having a fluid seal portion that seals the fluid at a proximal portion of the tubular body; and a force that serves as an adapter connected to the catheter body.
  • the catheter system is characterized in that the seal is opened by inserting and inserting the adapter into the adapter, and the seal is closed by removing the seal portion with one action.
  • FIG. 1 is an overall schematic diagram of a catheter body for occluding a body lumen according to the present invention.
  • a proximal portion 103 having The material of the balloon is not particularly limited.
  • Polyurethane silicone rubber, polyethylene, polyamide, polyurethane, polyamide elastomer, polyester elastomer, latex rubber, SEBS (styrene-ethylene-butylene-styrene block polymer), SI BS
  • styrene-ethylene-butylene-styrene block polymer polystyrene-ethylene-butylene-styrene block polymer
  • SI BS styrene-ethylene-butylene-styrene block polymer
  • SI BS relatively flexible material such as (styrene isobutylene-styrene block polymer) can be suitably used. There are no particular restrictions on the material of the main shaft.
  • Polyimide stainless steel, Ni-Ti, Ni-Ti-Fe, Ni-Ti-Cu, Ni-Ti-Cr, Ni-Ti V ⁇ Ni-Ti Co Ni—Ti Nb, Ni—Ti Pd ⁇ Ni—Ti Cu—Cr ⁇ Fe Mn—Si, Co—Cr, etc. are used alone or in combination to optimize the axial direction in consideration of the strength balance of the catheter. Can be used with various material arrangements.
  • FIG. 2 is a schematic diagram showing a state where the seal portion of the catheter body is inserted into the adapter 204 and inserted.
  • a syringe 206 for expanding or contracting the balloon is connected to the adapter via a connection circuit 205 between the adapter and the syringe.
  • Fig. 2 shows an example in which an adapter and a syringe for expanding or deflating a balloon are connected by a circuit.
  • a device for controlling a fluid for expanding or deflating a balloon may be incorporated in the force adapter.
  • valve 3 is an example of a seal portion formed in the proximal portion 303 of the tubular body (main shaft 3002) of the catheter body of the present invention, and is a schematic view showing a state V not inserted into the adapter. Inserted into the adapter! In this state, the taper partial force of the valve body 307 that substantially seals the fluid is pressed against the sealing surface 308 formed in a taper shape on the catheter body side by the panel 310 and closely contacts Due to seal It is made. In this state, the valve body 307 is in a state where the valve body 307 enters the inside of the taper relative to the proximal end 309 of the catheter body, but there is little possibility of unintentional opening and closing that makes the valve body difficult to contact with the other.
  • valve body and the seal surface is an important factor for the reliability of the seal, and it is preferable to finish the contact surface of both of them as a mirror surface, or to arrange a material more flexible than the other on at least one surface Place the urethane taper coating on the taper taper made of MASUGA STAINLESS, or place the valve body in a stainless steel and a thin polyimide resin on the sealing surface of the catheter body. From the viewpoint of dimensional control and durability. To preferred.
  • FIG. 4 is a schematic diagram showing an example of the adapter of the present invention.
  • the adapter 1 has an insertion portion 412 to be inserted by inserting the seal portion of the catheter body, and the insertion portion is preferably such that the shaft of the seal portion to be inserted is always inserted at a fixed position with respect to the adapter.
  • the cross-sectional shape of the insertion portion is similar to the cross-sectional shape of the catheter seal portion.
  • the cross-sectional shape of the insertion portion is also circular, which makes it easy to insert the shaft of the seal portion at a constant position with respect to the adapter and opens and closes the seal. It is preferable because the operation is more stable.
  • the adapter outermost surface portion of the insertion portion has a tapered portion 425 opened outward in a tapered shape.
  • the airtight member 413 it is preferable that the material has rubber elasticity because it maintains the airtightness and immediately exhibits the retainability of the catheter body.
  • the forcetail body A shape that covers the outer surface without any gap is preferred.
  • the adapter has a holding mechanism for fixing the relative position of the catheter body and the adapter because the operation is more stable.
  • a mechanism that does not require complicated operations is preferred. For example, as shown in FIG. 4, in a normal state, if the catheter holding portion 414 protrudes on the inner surface of the insertion portion by the spring material 415 and the member 416 connected to both, the catheter body is inserted into the adapter. If the member 416 is pressed so as to compress the panel at the same time, the catheter holding portion 414 can be retracted from the inner surface of the insertion portion, and the member 416 is released after the catheter body is disposed in the insertion portion.
  • the catheter holding portion 514 is preferable because it can hold the catheter body without excessive movement.
  • the valve body 307 as illustrated in FIG. 3 has a seal portion that enters the inside of the catheter relative to the proximal end 309 of the catheter body.
  • the valve body is attached to the adapter insertion portion in accordance with the operation of inserting and inserting the seal portion of the force tape body into the adapter. It is preferable to use an adapter of a type in which the seal is opened by being displaced by the structure.
  • FIG. 5 shows the force when the catheter body is inserted and inserted into the adapter.
  • the protruding structure 517 places the valve body 507 in the catheter relative to the proximal end 509 of the catheter body.
  • the protrusion-like structure is not particularly limited as long as it has a shape that allows the balloon expansion and contraction fluid to be taken in and out of the catheter, but it is a hollow tubular structure that expands the balloon inside.
  • a structure that allows the fluid for contraction to pass is preferable because a sufficient fluid flow rate can be secured.
  • stainless steel is preferable from the viewpoint of workability which requires a certain degree of strength because it must be brought into contact with the valve body and moved, and is preferably a metal material.
  • the portion 518 that is cut obliquely at the tip of the cylindrical structure because the flow rate of the fluid is ensured and it is easy to insert into the proximal end of the catheter. It is preferable to provide a hole 519 for allowing fluid to pass through on the side of the structure, since it makes it easier to secure the flow rate of the fluid.
  • FIG. 6 shows another preferred example of the seal portion formed in the proximal 603 of the tubular body (main shaft 602) of the catheter body according to the present invention, and shows a state in which it is inserted into the adapter. It is a schematic diagram. Inserted into the adapter! In the state, it substantially seals the fluid. Taper partial force of the valve body 607 The panel 610 is pressed against the sealing surface 608 formed in a taper shape on the catheter body side to be in close contact with it. The seal is achieved. In this state, the protruding portion 621 of the valve body 607 protrudes to the outside of the catheter relative to the proximal end 609 of the catheter body, but the valve body is manually operated when urgent balloon deflation is necessary.
  • the valve body may be more preferable than the example shown in Fig. 3, because the valve body is less susceptible to contact with others.
  • an adapter as shown in FIG. 7 is preferably applied.
  • the seal structure of the catheter body is inserted into the adapter and inserted into the adapter by a pressing structure 722 that is arranged in the adapter insertion portion and pushes the protruding portion of the valve body outside the catheter.
  • the valve body is displaced by the pressing structure, whereby the seal is opened.
  • FIG. 8 shows a state in which the catheter body is inserted and inserted into the adapter.
  • the pressing structure 822 has the protruding portion 821 of the valve body pushed into the proximal end 809 of the catheter body.
  • the material and structure of the pressing structure disposed in the insertion portion of the adapter are not particularly defined, but the mesh-like structure that can pass the fluid for expanding or contracting the balloon has good fluid permeability. This is preferable because a sufficient flow rate can be secured. Further, it is preferable that the mesh is made of metal since it has sufficient strength against pressing.
  • the pressing structure disposed in the insertion portion of the adapter is a porous structure that can pass a fluid for expanding or contracting the balloon, so that sufficient strength against pressing can be imparted. For this reason, a sintered porous body of metal or ceramic that is preferred is preferred for its strength.
  • the present invention can provide a detachable adapter that is easy to operate, so a balloon for removing thrombus and foreign matter of the type that uses a shaft of a force tail as a guide wire for guiding another catheter. It is suitably used for a catheter system.
  • the main shaft consists of a cylindrical proximal shaft with a 0.33 mm outer diameter (made of stainless steel coated with Teflon (registered trademark)) and a cylindrical distal shaft with a 0.33 mm outer diameter (surface Teflon). (Registered trademark) coated NiTi steel).
  • a polyurethane balloon, polyethylene on the inner surface of the guide wire lumen, and a tip shaft composed of polyamide elastomer as the main body were assembled and connected to the main shaft.
  • a cylindrical stainless steel tube with an outer diameter of 0.35 mm is used to draw the proximal end of the force tape body so that the outer diameter is 0.27 mm (the inner diameter is 0.21 mm).
  • a catheter body for body lumen occlusion of approximately 1800 mm was produced.
  • it has a circular section with an inner diameter of 0.42 mm, and has an insertion portion into which the seal portion of the catheter body is inserted and inserted, and the adapter outermost surface portion of the insertion portion is tapered and opened outward.
  • An adapter with the configuration shown in Fig. 4 is made of a hollow cylindrical structure with an outer diameter of 0.18mm, made of stainless steel, with its tip cut diagonally and with holes formed on its side. As a result, a catheter system as shown in FIG. 2 was obtained.
  • the main shaft is a cylindrical proximal shaft with a circular outer diameter of 0.33 mm (made of stainless steel coated with Teflon (registered trademark)) and a cylindrical distal shaft with a circular outer diameter of 0.33 mm (surface Teflon) (Registered trademark) coated NiTi steel).
  • a polyurethane balloon, polyethylene on the inner surface of the guide wire lumen, and a tip shaft composed of polyamide elastomer as the main body were assembled and connected to the main shaft.
  • a cylindrical stainless steel tube with a cross section of 0.36 mm in outer diameter is attached to the end of the force tape body, which is proximal to the outer diameter of 0.29 mm (a polyimide thin-film tubular body is attached to the inside of this portion, and the inner diameter is 0.20 mm. )
  • And parts with a maximum diameter of 0.25 mm From the proximal end of the catheter body to the outside of the catheter about 1.5 mm, with the valve body having a taper with a minimum diameter of 0.17 mm and the protrusion of the valve body with an outer diameter of 0.17 mm.
  • a seal part was constructed as shown in FIG. 6 to produce a body lumen occlusion catheter body having a total length of about 1800 mm.
  • the catheter body has a circular section with an inner diameter of 0.42 mm, and has an insertion part that is inserted and inserted into the seal portion of the catheter body, and the adapter outermost surface part of the insertion part is opened in a tapered shape.
  • the catheter body When the catheter body is inserted and inserted into the polycarbonate adapter and the silicon airtight member and adapter placed in the insertion section, it has a holding mechanism to fix the relative position of the catheter body and the adapter. Then, a pressing structure having a stainless steel metal mesh (SUS304-350) force is placed in the insertion portion to produce an adapter having the configuration shown in FIG. 7, and a catheter system as shown in FIG. 2 is obtained. It was.
  • SUS304-350 stainless steel metal mesh
  • a percussion occlusion balloon catheter (G14-6-200A), which is a body lumen occlusion catheter manufactured by Medtronic, was used.
  • Example 1 Using the above-mentioned catheter for occluding a body lumen in Example 1, an attempt was made to simulate dilation with an expansion balloon and the generated thrombus and atheroma suction while the internal carotid artery of the pig was occluded.
  • a 6F guide catheter was inserted from the porcine femoral artery and placed up to the common carotid artery.
  • the catheter body of Example 1 was inserted into the internal carotid artery through the guide catheter.
  • the dilatation balloon catheter prepared for dilatation was advanced to the vicinity of the balloon portion of the catheter for occlusion of the inner diameter artery.
  • the contrast medium 50% physiological saline was introduced into the balloon through the adapter, and the balloon was expanded to occlude the internal carotid artery. .
  • the Tetel was expanded to maintain the expanded state for 30 seconds, and then the expanded balloon was deflated.
  • the adapter of the catheter system of Example 1 was removed, and the dilatation balloon catheter was removed with the balloon of the occlusion catheter expanded.
  • Thrombus suction force After removing the tape, connect the adapter to the catheter body of Example 1 again, then remove the contrast medium through the adapter, deflate the balloon, recirculate the blood flow, and then the catheter system of Example 1. was removed from the body.
  • the force at the time of connecting the adapter to the body lumen occlusion force tail of Example 1 The time to recirculate the blood flow was 3 minutes 40 seconds o
  • FIG. 1 is a schematic diagram of a catheter body for explaining an embodiment of a catheter system according to the present invention.
  • FIG. 2 is a schematic diagram for explaining an embodiment of the catheter system according to the present invention.
  • FIG. 3 is a schematic diagram of one embodiment of the proximal portion of the catheter body according to the present invention.
  • FIG. 4 is a schematic diagram of one embodiment of a catheter adapter according to the present invention.
  • FIG. 5 is a schematic diagram of one embodiment of a catheter system according to the present invention.
  • FIG. 6 is a schematic diagram of one embodiment of the proximal portion of the catheter body according to the present invention.
  • FIG. 7 is a schematic diagram of one embodiment of a catheter adapter according to the present invention.
  • FIG. 8 is a schematic diagram of one embodiment of a catheter body according to the present invention.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Pulmonology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
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Abstract

In a catheter system having a balloon which is to be transdermally and transluminally introduced into the body for obstructing a hollow organ in the body, it is sometimes required to provide a detachable adaptor for inflating and deflating the balloon. It is also required to attach/detach the adaptor while maintaining the balloon in the inflated state. Existing adaptors suffer from a problem that a complicated procedure is needed and thus the obstruction time is prolonged. This problem can be solved by providing a catheter system comprising a balloon, a tubular member having an inflation lumen, the main catheter body having a fluid-sealing part, and an adaptor to be connected to the main catheter body, characterized in that the seal is opened by inserting the main catheter body and the sealing part into the adaptor and closed by drawing off the sealing part from the adaptor, thereby saving the troubles in the procedure.

Description

明 細 書  Specification
力テーテノレシステム  Force tester system
技術分野  Technical field
[0001] 本発明は、経皮的経管的に体内に導入され、体内の管腔を閉塞したり、血栓ゃ異 物を除去するためのバルーンを有するカテーテルシステムに関する。  [0001] The present invention relates to a catheter system having a balloon which is introduced into the body percutaneously and transluminally to close the lumen of the body or to remove foreign substances from the thrombus.
背景技術  Background art
[0002] 従来、血管などの脈管において狭窄あるいは閉塞が生じた場合、血管の狭窄部 位あるいは閉塞部位を拡張して、血管末梢側の血流を改善するために行う血管成形 術 (PTA: Percutaneous Transluminal Angioplasty ^ PTCA: Percutaneous Translumina 1 Coronary Angioplastyなど）は、多くの医療機関において多数の術例があり、この種 の症例における手術としては一般的になっている。さらに、拡張した狭窄部の状態を 保持するためのステント等も近年多く用いられるようになってきた。  [0002] Conventionally, when stenosis or occlusion occurs in a blood vessel such as a blood vessel, angioplasty (PTA) is performed to improve the blood flow on the peripheral side of the blood vessel by expanding the stenosis or occlusion site of the blood vessel. Percutaneous Transluminal Angioplasty ^ PTCA: Percutaneous Translumina 1 Coronary Angioplasty, etc.) has a large number of surgical cases in many medical institutions, and it has become a common operation for this type of case. Furthermore, stents and the like for maintaining the state of the expanded stenosis have been used in recent years.
[0003] PTA、 PTCAに用いられるバルーンカテーテルは、主に血管の狭窄部位あるいは 閉塞部位を拡張するために、ガイドカテーテルとガイドワイヤーとのセットで使用され る。このバルーンカテーテルを用いた血管成形術は、まずガイドカテーテルを大腿動 脈から挿入して大動脈を経て冠状動脈の入口に先端を位置させた後、バルーンカテ 一テルを貫通させたガイドワイヤーを血管の狭窄部位あるいは閉塞部位を越えて前 進させ、その後バルーンカテーテルをガイドワイヤーに沿って前進させ、バルーンを 狭窄部位あるいは閉塞部位に位置させた状態で膨張させて、狭窄部位あるいは閉 塞部位を拡張する手順で行い、そしてバルーンを収縮させて体外に除去する。この バルーンカテーテルは、血管の狭窄部位ある 、は閉塞部位の治療だけに限定され ず、血管内への挿入、並びに種々の体腔、管状組織への挿入を含む多くの医療的 用途に有用である。  [0003] Balloon catheters used for PTA and PTCA are mainly used as a set of a guide catheter and a guide wire in order to expand a stenosis site or a blockage site of a blood vessel. In angioplasty using this balloon catheter, a guide catheter is first inserted from the femoral artery, the tip is positioned at the entrance of the coronary artery via the aorta, and then a guide wire penetrating the balloon catheter is inserted into the blood vessel. Advance beyond the stenosis or occlusion site, and then advance the balloon catheter along the guide wire to expand the stenosis or occlusion site by inflating the balloon with the balloon positioned at the stenosis or occlusion site The procedure is performed and the balloon is deflated and removed from the body. This balloon catheter is not limited to the treatment of stenosis or occlusion in blood vessels, but is useful for many medical applications including insertion into blood vessels and insertion into various body cavities and tubular tissues.
[0004] し力しながら、血管内の閉塞が血栓による場合、閉塞部位をバルーンカテーテルで 拡張すると、血栓が血管内壁より遊離して下流側の末梢血管を閉塞させてしまう場合 がある。また、血管内の狭窄部位を拡張する場合も病変部が粥状のプラークを多く含 む場合などでは、バルーンカテーテルによる拡張で病変部より粥状のプラーク（ァテ ローム）が飛散してしまい、末梢血管を閉塞させてしまう場合がある。このように末梢 血管を閉塞させてしまう血栓ゃァテロームのような塞栓性物質が発生する場合は、閉 塞部や狭窄部を拡張しても、末梢に血流が流れなくなってしまい、スローフローゃノ 一フローの状況に陥る。 However, when the occlusion in the blood vessel is caused by a thrombus, the blood clot may be released from the inner wall of the blood vessel and occlude the downstream peripheral blood vessel. In addition, when a stenotic site in a blood vessel is expanded, if the lesion contains a large number of rod-like plaques, expansion by a balloon catheter causes a plaque-like plaque (character) from the lesion. (ROHM) may scatter and obstruct peripheral blood vessels. When an embolic material such as thrombosis or atheroma that occludes peripheral blood vessels is generated in this way, even if the obstruction or stenosis is expanded, blood flow does not flow to the periphery, so slow flow The situation falls into a single flow situation.
[0005] この様な状況に陥った場合、冠動脈などでは血流が回復するまで様子を見るのが 一般的であるが回復までには相当な時間が力る場合がある。また、状況に応じて血 管拡張剤を投与して血流の回復を図ったり、血栓溶解剤などの薬物を局所投与して 閉塞物を溶解させることが試みられるが、完全な血流回復までに至らない場合もある 。末梢閉塞がひどく血行動態が悪い場合は IABPなどの補助手段も用いられる。  [0005] In such a situation, it is common to look at the coronary artery or the like until the blood flow is recovered, but it may take a considerable amount of time to recover. Depending on the situation, vasodilators may be administered to restore blood flow, or drugs such as thrombolytic agents may be administered locally to dissolve obstructions. Sometimes it does not reach. If peripheral occlusion is severe and hemodynamics are poor, auxiliary means such as IABP are also used.
[0006] また、特に頸動脈や脳動脈における血管閉塞や血管狭窄の場合は、バルーンカテ 一テルゃステントで血管形成術を行うことで末梢閉塞が生じてしまうと、脳への血流 が停止してしまい閉塞部位の末梢の脳細胞が虚血状態になってしまう。脳の虚血状 態が長く続くと脳細胞の死滅が起こり、脳機能へ傷害が発生するという非常に危険な 状態も起こりうるため、脳動脈や頸動脈の血管形成術の場合は他の血管に比較して 特に末梢血管で閉塞が生じな 、ように十分な注意が必要である。  [0006] In particular, in the case of vascular occlusion or stenosis in the carotid artery or cerebral artery, blood flow to the brain stops when peripheral occlusion occurs due to angioplasty with a balloon catheter stent. As a result, the peripheral brain cells at the obstruction site become ischemic. In the case of angioplasty of cerebral arteries and carotid arteries, other ischemic conditions such as the death of brain cells and the damage to brain function may occur if brain ischemia continues for a long time. In particular, it is necessary to be careful not to cause obstruction in peripheral blood vessels.
[0007] この様に末梢の血管が閉塞をするのを防止するために、病変となる血管の末梢血 管を保護するために一時的に閉塞させて、その状態で病変部の血管形成術を行うこ とが試みられている。このようなデバイスは種々提案されている力 その例としてはフ ィルターデバイスや一時閉塞用バルーンカテーテルがあげられる。しかし、これらの デバイスを使用するときにはいくつかの問題が生じている。例えば、フィルターデバイ スを使用する場合、フィルタ一部分を病変部末梢まで挿入しフィルターを拡張する際 に、フィルターが過度に拡張されて血管に損傷を与えることがある。また、逆に拡張が 不充分な場合は血管の保護が出来て 、な 、ことになるが、それを確認する術がな ヽ 。その点、一時閉塞用バルーンカテーテルの場合、閉塞状態を造影上確認できるた め確実な閉塞が求められる病変に対して積極的に用いられることがある。一時閉塞 用バルーンカテーテルの問題点としては、保護するための閉塞中は末梢に血流も流 れないので、末梢が一時的に虚血状態になり易ぐ悪影響が出る可能性があることで ある。特に一時閉塞用バルーンカテーテルは、病変部末梢にてバルーンを拡張し、 その拡張を維持したまま、一時閉塞用バルーンカテーテルのシャフトに沿って他の力 テーテルの挿入及び抜去を行う必要性があることからフィルターデバイスに比べて操 作が煩雑なので、この問題点がより強く出やすい。そのため、バルーンの拡張、収縮 操作をなるベく早く行うこと、すなわち、拡張、収縮操作に必要な流体導入、排出の ためのアダプターとの接続性が非常に重要である。特許文献 1では、単一の膨張バ ルーンを利用して血流を閉塞するカテーテル及び膨張バルーンを膨張または収縮 するためのアダプターが開示されている。本先行技術におけるアダプタ一はカテー テル近位端部分に着脱自在であることしか記載されておらず、本先行技術における 伸長部材 (本発明での稼動部分)を操作する機能もアダプターには備えつけられて いない。このような場合、術者の手によって直接伸長部材が操作されるものと思われ る力 細いシャフトを直接手で操作するのはかなりの困難を伴う。伸長部材とカテーテ ル本体との適合及び流体シールはねじ切り加工又は摩擦により行われている力 ね じ切り加工の場合、実際の臨床現場において、細いシャフトに細い伸長部材をねじ により挿入することは非常に操作しにくぐスムーズな手技が行えないという問題点が ある。また摩擦による適合の場合、流体シールの能力を発揮するためには非常に精 密な公差を持って製造しなければならないという問題があるのと同時に、流体シール の能力を発揮するために摩擦抵抗が非常に大きぐ伸長部材を操作する際に細い伸 長部材ゃカテーテルシャフトを破壊するといつた問題があった。 [0007] In order to prevent the peripheral blood vessels from being occluded in this manner, the peripheral blood vessels of the blood vessels that become the lesions are temporarily occluded, and in that state, the angioplasty of the lesion is performed. Attempts to do so. Such devices have various proposed forces. Examples include filter devices and temporary occlusion balloon catheters. However, several problems have arisen when using these devices. For example, when a filter device is used, when the filter part is inserted to the periphery of the lesion and the filter is expanded, the filter may be excessively expanded to damage the blood vessel. On the other hand, if dilation is insufficient, the blood vessels can be protected, but there is no way to confirm it. On the other hand, in the case of a temporary occlusion balloon catheter, since the occlusion state can be confirmed on contrast, it may be actively used for lesions that require reliable occlusion. The problem with temporary occlusion balloon catheters is that blood flow does not flow to the periphery during occlusion for protection, and the periphery can easily become temporarily ischemic, which can have adverse effects. . In particular, temporary occlusion balloon catheters expand the balloon at the periphery of the lesion, This problem is exacerbated by the need to insert and remove other force tapers along the shaft of the temporary occlusion balloon catheter while maintaining its expansion, which is more complicated than the filter device. Easy to come out. Therefore, it is very important to perform balloon expansion and contraction operations as soon as possible, that is, connectivity to adapters for introducing and discharging fluids necessary for expansion and contraction operations. Patent Document 1 discloses a catheter for blocking blood flow using a single inflation balloon and an adapter for inflating or deflating an inflation balloon. It is only described that the adapter in the prior art is detachable from the proximal end portion of the catheter, and the adapter is also provided with a function for operating the extension member (the moving part in the present invention) in the prior art. Not. In such a case, it is considered that it is quite difficult to directly operate the thin shaft with the hand, which seems to be directly operated by the operator's hand. In the case of thread-cutting, the fitting between the extension member and the catheter body and the fluid seal are performed by threading or friction It is very difficult to insert a thin extension member into a thin shaft with a screw in an actual clinical setting. However, there is a problem that a smooth procedure that is difficult to operate cannot be performed. In addition, in the case of fitting by friction, there is a problem that in order to demonstrate the ability of the fluid seal, it must be manufactured with very close tolerances. When manipulating a very large elongate member, there was a problem when the thin elongate member was destroyed when the catheter shaft was broken.
[0008] 特許文献 2では、ロープ口ファイルのバルブを有したカテーテル及びそのバルブを 操作するためのインフレーションアダプタが開示されて 、る。本先行技術におけるァ ダブターは、第 1の部分及び第 2の部分を有するハウジング力 なり、そのハウジング 内にカテーテルを固定し、第 1の部分及び第 2の部分を合わせてロック ·クリップでノヽ ウジングを固定するという形状であり、 1つの操作で簡便にカテーテルを固定すること ができず、実際の臨床現場にぉ 、てスムーズな手技が行えな 、と 、う問題がある。  [0008] Patent Document 2 discloses a catheter having a rope mouth file valve and an inflation adapter for operating the valve. The adapter in this prior art is a housing force having a first part and a second part, which secures the catheter in the housing and aligns the first part and the second part with a locking clip and nosing. There is a problem that the catheter cannot be easily fixed by a single operation, and a smooth procedure cannot be performed in an actual clinical setting.
[0009] また、血栓や異物を除去するためのバルーンを有するカテーテルシステムについて は脱着可能なアダプタ一は複雑すぎて適用が難しぐカテーテルのシャフトを他の力 テーテルを誘導するガイドワイヤーとして使用することは出来ないという問題があった 特許文献 1 :特開 2002— 126093号公報 [0009] In addition, for a catheter system having a balloon for removing a thrombus or a foreign substance, the removable adapter is too complicated to be applied, and the catheter shaft should be used as a guide wire for guiding other forces. There was a problem that could not Patent Document 1: Japanese Unexamined Patent Application Publication No. 2002-126093
特許文献 2 :特表 2000— 511082号公報  Patent Document 2: Japanese Patent Publication No. 2000-511082
発明の開示  Disclosure of the invention
発明が解決しょうとする課題  Problems to be solved by the invention
[0010] これらの状況を鑑み、本発明が解決しょうとするところは、操作が非常に簡便で素 早く操作可能なカテーテルシステムを提供することである。 [0010] In view of these circumstances, the present invention is to provide a catheter system that is very simple and quick to operate.
課題を解決するための手段  Means for solving the problem
[0011] 上記課題を解決するための手段は、新しいバルーンを有するカテーテルシステム の構造、選択された材料配置により、カテーテル本体とバルーンの拡張、収縮操作 に必要な流体導入、排出のためのアダプターとの接続性 (操作の簡易性)を向上さ せることで、操作に要する手順を低減させたカテーテルシステムを提供することにあ る。すなわち、バルーンと、前記バルーンを拡張又は収縮させるための流体が移動 可能なインフレーションルーメンを有する管状体と、管状体の近位部分に前記流体を シールする流体シール部分を有するカテーテル本体と、カテーテル本体と接続され るアダプタ一力もなるカテーテルシステムであって、カテーテル本体のシール部分を アダプターに差込み挿入する操作でシールが開放状態になり、シール部分をァダプ ター力 抜去する操作でシールが閉塞状態になることを特徴とするカテーテルシステ ムであることから最小限の操作手順でカテーテル本体とアダプターの接続、取り外し 、カテーテル本体のシール開閉が行えることから本発明の課題が解決可能である。 発明の効果 [0011] Means for solving the above problems include an adapter for introducing and discharging a fluid necessary for the expansion and contraction operation of the catheter body and the balloon depending on the structure of the catheter system having a new balloon and the selected material arrangement. The purpose of the present invention is to provide a catheter system in which the procedure required for the operation is reduced by improving the connectivity (simpleness of operation). That is, a balloon, a tubular body having an inflation lumen through which a fluid for expanding or contracting the balloon can move, a catheter body having a fluid seal portion that seals the fluid at a proximal portion of the tubular body, and a catheter body The adapter system is connected to the catheter, and the seal is opened by inserting and inserting the seal portion of the catheter body into the adapter, and the seal is closed by removing the adapter force from the adapter. Since the catheter system is characterized in that the catheter body can be connected to and detached from the adapter and the catheter body can be opened and closed with a minimum operation procedure, the problem of the present invention can be solved. The invention's effect
[0012] 従来の体内の管腔を一時閉塞するバルーンを有するカテーテルはバルーンの拡 張、収縮操作に必要な流体導入、排出のためのアダプターとの接続性が悪く操作が 煩雑であった。本発明により、操作による手順が低減されたことからそれらの問題を 解決した。  [0012] Conventional catheters having a balloon that temporarily occludes a lumen in the body have poor connectivity with adapters for introducing and discharging fluids necessary for balloon expansion and contraction, and the operation is complicated. The present invention solves these problems because the procedure by operation is reduced.
発明を実施するための最良の形態  BEST MODE FOR CARRYING OUT THE INVENTION
[0013] 以下に本発明に係るカテーテルの最良の実施形態を説明する。本発明は、バル一 ンと、前記バルーンを拡張又は収縮させるための流体が移動可能なインフレーション ルーメンを有する管状体と、管状体の近位部分に前記流体をシールする流体シール 部分を有するカテーテル本体と、カテーテル本体と接続されるアダプタ一力 なる力 テーテルシステムであって、カテーテル本体のシール部分をアダプターに差込み揷 入する操作でシールが開放状態になり、シール部分をアダプタ一力 抜去する操作 でシールが閉塞状態になることを特徴とするカテーテルシステムである。 Hereinafter, the best embodiment of the catheter according to the present invention will be described. The present invention relates to inflation in which a balloon and a fluid for expanding or contracting the balloon are movable. A tubular body having a lumen; a catheter body having a fluid seal portion that seals the fluid at a proximal portion of the tubular body; and a force that serves as an adapter connected to the catheter body. The catheter system is characterized in that the seal is opened by inserting and inserting the adapter into the adapter, and the seal is closed by removing the seal portion with one action.
[0014] 図 1は、本発明に係る体内管腔閉塞用カテーテル本体の全体模式図である。バル ーン 101と、カテーテル手元端力もバルーン内部まで連通した前記バルーンを拡張 又は収縮させるための流体が移動可能なインフレーションルーメンを有した管状体で あるメインシャフト 102と、流体をシールする流体シール部分を有する近位部 103が ある。バルーンの材質については、特に制限はされず、ポリウレタン、シリコンゴム、ポ リエチレン、ポリアミド、ポリウレタン、ポリアミドエラストマ一、ポリエステルエラストマ一 、ラテックスゴム、 SEBS (スチレン一エチレンブチレン一スチレンブロック重合体）、 SI BS (スチレン イソブチレン—スチレンブロック重合体）、等の比較的柔軟な材料を 好適に用いるとことができる。メインシャフトの材料についても、特に制限はされず、ポ リイミド、ステンレス鋼、 Ni— Ti、 Ni— Ti— Fe、 Ni—Ti—Cu、 Ni— Ti— Cr、 Ni— Ti Vゝ Ni— Ti Co、 Ni— Ti Nb、 Ni— Ti Pdゝ Ni— Ti Cu— Crゝ Fe Mn— S i、 Co— Cr等の材料を単独もしくは複合ィ匕させ、カテーテルの強度バランスを考慮し て軸方向に最適な材料配置で使用できる。  FIG. 1 is an overall schematic diagram of a catheter body for occluding a body lumen according to the present invention. A balloon 101, a main shaft 102 having a tubular body having an inflation lumen through which a fluid for expanding or contracting the balloon, which has a proximal end force communicating with the inside of the balloon, can be moved, and a fluid seal portion for sealing the fluid There is a proximal portion 103 having The material of the balloon is not particularly limited. Polyurethane, silicone rubber, polyethylene, polyamide, polyurethane, polyamide elastomer, polyester elastomer, latex rubber, SEBS (styrene-ethylene-butylene-styrene block polymer), SI BS A relatively flexible material such as (styrene isobutylene-styrene block polymer) can be suitably used. There are no particular restrictions on the material of the main shaft. Polyimide, stainless steel, Ni-Ti, Ni-Ti-Fe, Ni-Ti-Cu, Ni-Ti-Cr, Ni-Ti V ゝ Ni-Ti Co Ni—Ti Nb, Ni—Ti Pd ゝ Ni—Ti Cu—Cr ゝ Fe Mn—Si, Co—Cr, etc. are used alone or in combination to optimize the axial direction in consideration of the strength balance of the catheter. Can be used with various material arrangements.
[0015] 図 2は、カテーテル本体のシール部分をアダプター 204に差込み挿入した状態を 示す模式図である。アダプターにはバルーンを拡張又は収縮させるためのシリンジ 2 06がアダプターとシリンジの接続回路 205を介して接続されている。図 2ではァダプ ターとバルーンを拡張又は収縮させるためのシリンジを回路で接続した例を示してい る力 アダプター内にバルーンを拡張又は収縮させるための流体を制御するための 装置を組み込んでもよ ヽ。図 3は本発明のカテーテル本体の管状体 (メインシャフト 3 02)の近位部 303に構成されたシール部分の一例で、アダプターに挿入されていな V、状態を示す模式図である。アダプターに挿入されて!、な 、状態では実質的に流体 をシールする弁体 307のテーパー部分力 カテーテル本体側にテーパー状に形成 されたシール面 308に対し、パネ 310により押されて密着することによりシールが達 成されている。この状態では弁体 307が、カテーテル本体近位端 309より相対的に力 テーテル内部に入った状態であるが、弁体が他との接触を受けにくぐ意図しない開 閉が起こる可能性が少な 、ことから好ま 、場合がある。弁体とシール面の密着性は シールの確実性に対して重要な要素であり、両者の接触面を鏡面状に仕上げること 、もしくは少なくとも一方の面に他方より柔軟な材料を配置することが好ましぐステン レス製の弁体テーパー部分にウレタン榭脂をコーティングする配置、または弁体をス テンレス、カテーテル本体のシール面にポリイミド榭脂を薄く配置すること力 寸法制 御的、耐久性という観点から好ましい。 FIG. 2 is a schematic diagram showing a state where the seal portion of the catheter body is inserted into the adapter 204 and inserted. A syringe 206 for expanding or contracting the balloon is connected to the adapter via a connection circuit 205 between the adapter and the syringe. Fig. 2 shows an example in which an adapter and a syringe for expanding or deflating a balloon are connected by a circuit. A device for controlling a fluid for expanding or deflating a balloon may be incorporated in the force adapter. FIG. 3 is an example of a seal portion formed in the proximal portion 303 of the tubular body (main shaft 3002) of the catheter body of the present invention, and is a schematic view showing a state V not inserted into the adapter. Inserted into the adapter! In this state, the taper partial force of the valve body 307 that substantially seals the fluid is pressed against the sealing surface 308 formed in a taper shape on the catheter body side by the panel 310 and closely contacts Due to seal It is made. In this state, the valve body 307 is in a state where the valve body 307 enters the inside of the taper relative to the proximal end 309 of the catheter body, but there is little possibility of unintentional opening and closing that makes the valve body difficult to contact with the other. If you like it, you may. The adhesion between the valve body and the seal surface is an important factor for the reliability of the seal, and it is preferable to finish the contact surface of both of them as a mirror surface, or to arrange a material more flexible than the other on at least one surface Place the urethane taper coating on the taper taper made of MASUGA STAINLESS, or place the valve body in a stainless steel and a thin polyimide resin on the sealing surface of the catheter body. From the viewpoint of dimensional control and durability. To preferred.
[0016] 図 4は本発明のアダプターの一例を示す模式図である。アダプタ一は、カテーテル 本体のシール部分を差込み挿入される挿入部 412を有し、挿入部は挿入されるシー ル部分の軸がアダプターに対し常に一定の位置で挿入されるようであることが好まし ぐ挿入部の断面形状とカテーテルシール部分の断面形状が相似であることがより好 ましい。例えばカテーテルのシール部分断面形状が円形である場合には、挿入部の 断面形状も円形であることが、シール部分の軸がアダプターに対し常に一定の位置 で挿入することを容易にし、シールの開閉動作がより安定することから好ましい。また 、アダプターにシール部分を挿入しやすくするために該揷入部のアダプター最外面 部がテーパー状に外に開いた、テーパー部分 425を有している形状であることが好 ましい。 FIG. 4 is a schematic diagram showing an example of the adapter of the present invention. The adapter 1 has an insertion portion 412 to be inserted by inserting the seal portion of the catheter body, and the insertion portion is preferably such that the shaft of the seal portion to be inserted is always inserted at a fixed position with respect to the adapter. It is more preferable that the cross-sectional shape of the insertion portion is similar to the cross-sectional shape of the catheter seal portion. For example, when the cross-sectional shape of the seal portion of the catheter is circular, the cross-sectional shape of the insertion portion is also circular, which makes it easy to insert the shaft of the seal portion at a constant position with respect to the adapter and opens and closes the seal. It is preferable because the operation is more stable. Further, in order to facilitate the insertion of the seal portion into the adapter, it is preferable that the adapter outermost surface portion of the insertion portion has a tapered portion 425 opened outward in a tapered shape.
[0017] バルーンの拡張や収縮をスムーズかつ確実に行うためには、アダプターにカテー テル本体が差込み挿入された場合に、カテーテルのインフレーションルーメンとァダ プターの流体供給部間が気密性を保持されている方が好ましぐそのために、ァダプ ターの挿入部中に気密部材 413を配置することが好ま 、。気密部材につ 、ては、 材質的にゴム弾性を有することが気密性を保持しやすぐカテーテル本体の保持性 も発揮することから好ましく、カテーテルのシール部分が挿入された場合に力テーテ ル本体外面を隙間無く覆う形状であることが好ましい。また、アダプターにカテーテル 本体が差込み挿入された場合に、カテーテル本体とアダプターの相対位置を固定す るための保持機構をアダプターに有することが、操作をより安定させることから好まし いが、保持機構としては煩雑な操作を要しない機構であるほうが発明の目的上好ま しぐ例えば図 4で示すような、通常状態ではカテーテル保持部分 414がバネ材 415 と両者に接続された部材 416により挿入部内面に突出している構造であれば、ァダ プターにカテーテル本体を挿入するために手にとると同時に部材 416をパネを圧縮 するように押圧すれば、カテーテル保持部分 414を挿入部内面より引き込めることが 出来、挿入部にカテーテル本体を配置した後に、部材 416をリリースすれば、ァダプ ターにカテーテル本体が差込み挿入された状態を示す図 5のように、カテーテル保 持部分 514でカテーテル本体を余分な動作なく保持可能とすることから好ま U、。図 3に例示されているような弁体 307が、カテーテル本体近位端 309より相対的にカテ 一テル内部に入った状態のシール部分を有するカテーテル本体に対しては、図 4に 示されるような、アダプターの挿入部に取り付けられた突起状の構造体 417により、力 テーテル本体のシール部分をアダプターに差込み挿入する操作に伴って、前記弁 体が前記アダプターの挿入部に取り付けられた突起状の構造体によって変位させら れることによりシールが開放状態となるような形式のアダプターを用いることが好まし い。 [0017] In order to smoothly and reliably expand and contract the balloon, when the catheter body is inserted and inserted into the adapter, the air tightness is maintained between the inflation lumen of the catheter and the fluid supply part of the adapter. Therefore, it is preferable to place an airtight member 413 in the adapter insertion portion. For the airtight member, it is preferable that the material has rubber elasticity because it maintains the airtightness and immediately exhibits the retainability of the catheter body. When the seal portion of the catheter is inserted, the forcetail body A shape that covers the outer surface without any gap is preferred. In addition, when the catheter body is inserted and inserted into the adapter, it is preferable that the adapter has a holding mechanism for fixing the relative position of the catheter body and the adapter because the operation is more stable. For the purpose of the invention, a mechanism that does not require complicated operations is preferred. For example, as shown in FIG. 4, in a normal state, if the catheter holding portion 414 protrudes on the inner surface of the insertion portion by the spring material 415 and the member 416 connected to both, the catheter body is inserted into the adapter. If the member 416 is pressed so as to compress the panel at the same time, the catheter holding portion 414 can be retracted from the inner surface of the insertion portion, and the member 416 is released after the catheter body is disposed in the insertion portion. Then, as shown in FIG. 5 showing the state where the catheter body is inserted and inserted into the adapter, the catheter holding portion 514 is preferable because it can hold the catheter body without excessive movement. As shown in FIG. 4, the valve body 307 as illustrated in FIG. 3 has a seal portion that enters the inside of the catheter relative to the proximal end 309 of the catheter body. In addition, with the protruding structure 417 attached to the adapter insertion portion, the valve body is attached to the adapter insertion portion in accordance with the operation of inserting and inserting the seal portion of the force tape body into the adapter. It is preferable to use an adapter of a type in which the seal is opened by being displaced by the structure.
[0018] 図 5にアダプターにカテーテル本体が差込み挿入された状態を示す力 突起状の 構造体 517が弁体 507をカテーテル本体近位端 509より相対的にカテーテル内部 に入った状態にしている。突起状の構造体は、その状態でカテーテル内部にバル一 ン拡張、収縮用の流体を出し入れ可能な形状であれば特に制限は無いが、中空の 筒状構造体で、内部に前記バルーンを拡張又は収縮させるための流体を通過させる 構造であることが充分な流体の流量を確保できることから好ましい。材質としては、弁 体と接触し、移動させなければならないため、ある程度の強度が必要で、金属材料で あることが好ましぐ加工性の面からステンレス鋼であることが好ましい。また、前記筒 状構造体の先端に斜めにカットしてある部分 518を有する方が、流体の流量を確保 しゃすぐ加えてカテーテル近位端に挿入しやすくなることから好ましぐ前記筒状構 造体の側面に流体を通過させるための孔 519を設けることは流体の流量をさらに確 保しやすくすることから好まし 、。  [0018] FIG. 5 shows the force when the catheter body is inserted and inserted into the adapter. The protruding structure 517 places the valve body 507 in the catheter relative to the proximal end 509 of the catheter body. The protrusion-like structure is not particularly limited as long as it has a shape that allows the balloon expansion and contraction fluid to be taken in and out of the catheter, but it is a hollow tubular structure that expands the balloon inside. Alternatively, a structure that allows the fluid for contraction to pass is preferable because a sufficient fluid flow rate can be secured. As a material, stainless steel is preferable from the viewpoint of workability which requires a certain degree of strength because it must be brought into contact with the valve body and moved, and is preferably a metal material. In addition, it is preferable to have the portion 518 that is cut obliquely at the tip of the cylindrical structure because the flow rate of the fluid is ensured and it is easy to insert into the proximal end of the catheter. It is preferable to provide a hole 519 for allowing fluid to pass through on the side of the structure, since it makes it easier to secure the flow rate of the fluid.
[0019] 図 6は本発明のカテーテル本体の管状体 (メインシャフト 602)の近位 603に構成さ れたシール部分の好ま 、別の一例で、アダプターに挿入されて ヽな 、状態を示す 模式図である。アダプターに挿入されて!、な 、状態では実質的に流体をシールする 弁体 607のテーパー部分力 カテーテル本体側にテーパー状に形成されたシール 面 608に対し、パネ 610により押されて密着することによりシールが達成されている。 この状態では弁体 607の突出した部分 621が、カテーテル本体近位端 609より相対 的にカテーテル外部に突出して 、る状態であるが、緊急のバルーン収縮が必要にな つた場合に弁体を手動で操作可能であり、また弁の開閉状態が常に目視で確認でき る利点があることから、適用する部位によっては弁体が他との接触を受けにくい図 3 の例よりも好ましい場合がある。この形式のカテーテル本体に対しては、例えば図 7 に示されるようなアダプターがこの好ましく適用される。図 7のアダプターでは、ァダプ ターの挿入部に配置され、前記弁体のカテーテル外部に突出した部分を押すような 押し当て構造体 722により、カテーテル本体のシール部分をアダプターに差込み挿 入する操作に伴って、前記弁体が前記押し当て構造体によって変位させられること によりシールが開放状態となる。図 8にアダプターにカテーテル本体が差込み挿入さ れた状態を示すが、押し当て構造体 822が弁体の突出した部分 821をカテーテル本 体近位端 809まで押し入った状態にして 、る。前記アダプターの挿入部に配置され た押し当て構造体の材質、構造には特に規定されないが、前記バルーンを拡張又は 収縮させるための流体を通過させることの出来るメッシュ状構造体力 流体の通過性 が良ぐ流量を確保できるので好ましい。また、メッシュが金属製であることが押し当て に対する充分な強度を有することから好ましい。また、前記アダプターの挿入部に配 置された押し当て構造体は、前記バルーンを拡張又は収縮させるための流体を通過 させることの出来る多孔構造体であることが、押し当てに対する充分な強度付与可能 であることから好ましぐ金属もしくはセラミックスの焼結多孔体が強度の面力 好まし い。 FIG. 6 shows another preferred example of the seal portion formed in the proximal 603 of the tubular body (main shaft 602) of the catheter body according to the present invention, and shows a state in which it is inserted into the adapter. It is a schematic diagram. Inserted into the adapter! In the state, it substantially seals the fluid. Taper partial force of the valve body 607 The panel 610 is pressed against the sealing surface 608 formed in a taper shape on the catheter body side to be in close contact with it. The seal is achieved. In this state, the protruding portion 621 of the valve body 607 protrudes to the outside of the catheter relative to the proximal end 609 of the catheter body, but the valve body is manually operated when urgent balloon deflation is necessary. In some cases, the valve body may be more preferable than the example shown in Fig. 3, because the valve body is less susceptible to contact with others. For this type of catheter body, for example, an adapter as shown in FIG. 7 is preferably applied. In the adapter of FIG. 7, the seal structure of the catheter body is inserted into the adapter and inserted into the adapter by a pressing structure 722 that is arranged in the adapter insertion portion and pushes the protruding portion of the valve body outside the catheter. Along with this, the valve body is displaced by the pressing structure, whereby the seal is opened. FIG. 8 shows a state in which the catheter body is inserted and inserted into the adapter. The pressing structure 822 has the protruding portion 821 of the valve body pushed into the proximal end 809 of the catheter body. The material and structure of the pressing structure disposed in the insertion portion of the adapter are not particularly defined, but the mesh-like structure that can pass the fluid for expanding or contracting the balloon has good fluid permeability. This is preferable because a sufficient flow rate can be secured. Further, it is preferable that the mesh is made of metal since it has sufficient strength against pressing. In addition, the pressing structure disposed in the insertion portion of the adapter is a porous structure that can pass a fluid for expanding or contracting the balloon, so that sufficient strength against pressing can be imparted. For this reason, a sintered porous body of metal or ceramic that is preferred is preferred for its strength.
[0020] また、本発明は、操作が簡便な脱着可能なアダプターを提供できるため、力テーテ ルのシャフトを他のカテーテルを誘導するガイドワイヤーとして使用するタイプの血栓 や異物を除去するためのバルーンカテーテルシステムへも好適に用いられる。  [0020] In addition, the present invention can provide a detachable adapter that is easy to operate, so a balloon for removing thrombus and foreign matter of the type that uses a shaft of a force tail as a guide wire for guiding another catheter. It is suitably used for a catheter system.
実施例  Example
[0021] 以下に本発明に係るより具体的な実施例と比較例について詳説する。 (実施例 1) Hereinafter, more specific examples and comparative examples according to the present invention will be described in detail. (Example 1)
メインシャフトは外径 0. 33mmの断面円形の筒状手元側シャフト（表面テフロン (登 録商標)コーティングされたステンレス鋼製)と外径 0. 33mmの断面円形の筒状先端 側シャフト（表面テフロン (登録商標）コーティングされた NiTi鋼製)のシャフトを用い て構成した。ポリウレタン製のバルーン、ガイドワイヤールーメン内面がポリエチレン、 本体はポリアミドエラストマ一力も構成されたチップシャフト、を組み立てメインシャフト に接続した。それに外径 0. 35mmの断面円形の筒状ステンレスチューブで力テーテ ル本体の近位となる末端を外径 0. 27mm (該部分の内径は 0. 21mm)になるように 絞り加工した部品と、最大径 0. 25mmから最小径 0. 19mmまでのテーパーを有し、 テーパー表面にウレタン榭脂を塗布された弁体と、パネを組み合わせて図 3に示すよ うにシール部分を構成し、全長が約 1800mmの体内管腔閉塞用カテーテル本体を 作製した。また、内径 0. 42mmの断面円形である、カテーテル本体のシール部分を 差込み挿入される挿入部を有し、該揷入部のアダプター最外面部がテーパー状に 外に開いている形状にカ卩ェされたポリカーボネート製のアダプターと、挿入部中配置 されたシリコン製の気密部材とアダプターにカテーテル本体が差込み挿入された場 合に、カテーテル本体とアダプターの相対位置を固定するための保持機構を有し、 挿入部中に取り付けられた、ステンレス製で先端が斜めにカットされ、側面に孔が形 成してある外径 0. 18mmの中空筒状構造体を有する図 4に示す構成のアダプター を作製し、図 2で表されるようなカテーテルシステムを得た。  The main shaft consists of a cylindrical proximal shaft with a 0.33 mm outer diameter (made of stainless steel coated with Teflon (registered trademark)) and a cylindrical distal shaft with a 0.33 mm outer diameter (surface Teflon). (Registered trademark) coated NiTi steel). A polyurethane balloon, polyethylene on the inner surface of the guide wire lumen, and a tip shaft composed of polyamide elastomer as the main body were assembled and connected to the main shaft. In addition, a cylindrical stainless steel tube with an outer diameter of 0.35 mm is used to draw the proximal end of the force tape body so that the outer diameter is 0.27 mm (the inner diameter is 0.21 mm). , Which has a taper with a maximum diameter of 0.25 mm to a minimum diameter of 0.19 mm, and combines a valve body coated with urethane resin on the taper surface and a panel to form a seal part as shown in Fig. 3. A catheter body for body lumen occlusion of approximately 1800 mm was produced. In addition, it has a circular section with an inner diameter of 0.42 mm, and has an insertion portion into which the seal portion of the catheter body is inserted and inserted, and the adapter outermost surface portion of the insertion portion is tapered and opened outward. When the catheter body is inserted and inserted into the adapter made of polycarbonate, the silicone airtight member arranged in the insertion section, and the adapter, it has a holding mechanism for fixing the relative position of the catheter body and the adapter. An adapter with the configuration shown in Fig. 4 is made of a hollow cylindrical structure with an outer diameter of 0.18mm, made of stainless steel, with its tip cut diagonally and with holes formed on its side. As a result, a catheter system as shown in FIG. 2 was obtained.
(実施例 2) (Example 2)
メインシャフトは外径 0. 33mmの断面円形の筒状手元側シャフト（表面テフロン（ 登録商標)コーティングされたステンレス鋼製)と外径 0. 33mmの断面円形の筒状先 端側シャフト（表面テフロン (登録商標)コーティングされた NiTi鋼製)のシャフトを用い て構成した。ポリウレタン製のバルーン、ガイドワイヤールーメン内面がポリエチレン、 本体はポリアミドエラストマ一力も構成されたチップシャフト、を組み立てメインシャフト に接続した。それに外径 0. 36mmの断面円形の筒状ステンレスチューブで力テーテ ル本体の近位となる末端を外径 0. 29mm (該部分の内側にはポリイミドの薄膜管状 体を取り付け内径は 0. 20mm)になるように絞り加工した部品と、最大径 0. 25mm から最小径 0. 17mmまでのテーパーを有した弁体と、パネを外径 0. 17mmの弁体 の突出した部分が、カテーテル本体近位端より相対的にカテーテル外部に約 1. 5m m突出して 、る状態で組み合わせて図 6に示すようにシール部分を構成し、全長が 約 1800mmの体内管腔閉塞用カテーテル本体を作製した。また、内径 0. 42mmの 断面円形である、カテーテル本体のシール部分を差込み挿入される挿入部を有し、 該揷入部のアダプター最外面部がテーパー状に外に開いている形状にカ卩ェされた ポリカーボネート製のアダプターと、挿入部中配置されたシリコン製の気密部材とァダ プターにカテーテル本体が差込み挿入された場合に、カテーテル本体とアダプター の相対位置を固定するための保持機構を有し、挿入部中にステンレス製金属メッシ ュ（SUS304— 350)力もなる押し当て構造体を配置して図 7に示す構成のアダプタ 一を作製し、図 2で表されるようなカテーテルシステムを得た。 The main shaft is a cylindrical proximal shaft with a circular outer diameter of 0.33 mm (made of stainless steel coated with Teflon (registered trademark)) and a cylindrical distal shaft with a circular outer diameter of 0.33 mm (surface Teflon) (Registered trademark) coated NiTi steel). A polyurethane balloon, polyethylene on the inner surface of the guide wire lumen, and a tip shaft composed of polyamide elastomer as the main body were assembled and connected to the main shaft. A cylindrical stainless steel tube with a cross section of 0.36 mm in outer diameter is attached to the end of the force tape body, which is proximal to the outer diameter of 0.29 mm (a polyimide thin-film tubular body is attached to the inside of this portion, and the inner diameter is 0.20 mm. ) And parts with a maximum diameter of 0.25 mm From the proximal end of the catheter body to the outside of the catheter about 1.5 mm, with the valve body having a taper with a minimum diameter of 0.17 mm and the protrusion of the valve body with an outer diameter of 0.17 mm. In this state, a seal part was constructed as shown in FIG. 6 to produce a body lumen occlusion catheter body having a total length of about 1800 mm. In addition, it has a circular section with an inner diameter of 0.42 mm, and has an insertion part that is inserted and inserted into the seal portion of the catheter body, and the adapter outermost surface part of the insertion part is opened in a tapered shape. When the catheter body is inserted and inserted into the polycarbonate adapter and the silicon airtight member and adapter placed in the insertion section, it has a holding mechanism to fix the relative position of the catheter body and the adapter. Then, a pressing structure having a stainless steel metal mesh (SUS304-350) force is placed in the insertion portion to produce an adapter having the configuration shown in FIG. 7, and a catheter system as shown in FIG. 2 is obtained. It was.
(比較例） (Comparative example)
比較例として、メドトロニック社製の体内管腔閉塞用カテーテルである、パーキュ サージ ォクルージョンバルーンカテーテル（G14— 6— 200A)を用いた。  As a comparative example, a percussion occlusion balloon catheter (G14-6-200A), which is a body lumen occlusion catheter manufactured by Medtronic, was used.
(評価）  (Evaluation)
上記、実施例 1の体内管腔閉塞用カテーテルを用い、ブタの内頸動脈の閉塞を行 つた状態で拡張バルーンによる拡張治療と発生した血栓、ァテローム吸引の模擬的 な治療を試みた。ブタ大腿動脈より 6Fガイドカテーテルを挿入、総頸動脈まで配置し た。該ガイドカテーテルを通して実施例 1のカテーテル本体を内頸動脈内まで挿入し た。実施例 1のカテーテル本体のメインシャフトをガイドワイヤーのように使用して拡張 準備がされた拡張バルーンカテーテルを内径動脈の閉塞用カテーテルのバルーン 部分近傍まで進めた。実施例 1のカテーテル本体にアダプターのロック機構を開放し つつ挿入して接続して後、アダプターを通じて造影剤 50%生理食塩水をバルーン 内に導入、バルーンを拡張させて内頸動脈を閉塞させた。すぐさま拡張バルーン力 テーテルを拡張して 30秒拡張状態を維持した後、拡張バルーンを収縮させた。実施 例 1のカテーテルシステムのアダプターを取り外し、閉塞用カテーテルのバルーンを 拡張させた状態で、拡張バルーンカテーテルを抜去した。引き続き、血栓吸引カテ 一テルを実施例 1のカテーテル本体のメインシャフトをガイドワイヤーのように使用し て閉塞用カテーテルのバルーン部分近傍まで進め、吸引操作を行った。血栓吸引力 テーテルを抜去した後、実施例 1のカテーテル本体に再度アダプターを接続して後、 アダプターを通じて造影剤を抜き去りバルーンを収縮させ血流を再行させて後、実施 例 1のカテーテルシステムを体外へ抜去した。実施例 1の体内管腔閉塞用力テーテ ルにアダプターを接続する時点力 血流を再行させるまでの時間は、 3分 40秒であ つた o Using the above-mentioned catheter for occluding a body lumen in Example 1, an attempt was made to simulate dilation with an expansion balloon and the generated thrombus and atheroma suction while the internal carotid artery of the pig was occluded. A 6F guide catheter was inserted from the porcine femoral artery and placed up to the common carotid artery. The catheter body of Example 1 was inserted into the internal carotid artery through the guide catheter. Using the main shaft of the catheter body of Example 1 like a guide wire, the dilatation balloon catheter prepared for dilatation was advanced to the vicinity of the balloon portion of the catheter for occlusion of the inner diameter artery. After inserting and connecting the adapter locking mechanism to the catheter body of Example 1, the contrast medium 50% physiological saline was introduced into the balloon through the adapter, and the balloon was expanded to occlude the internal carotid artery. . Immediately expandable balloon force The Tetel was expanded to maintain the expanded state for 30 seconds, and then the expanded balloon was deflated. The adapter of the catheter system of Example 1 was removed, and the dilatation balloon catheter was removed with the balloon of the occlusion catheter expanded. Subsequently, use the main shaft of the catheter body of Example 1 as a guide wire for the thrombus aspiration catheter. Then, the catheter was advanced to the vicinity of the balloon portion of the occlusion catheter, and a suction operation was performed. Thrombus suction force After removing the tape, connect the adapter to the catheter body of Example 1 again, then remove the contrast medium through the adapter, deflate the balloon, recirculate the blood flow, and then the catheter system of Example 1. Was removed from the body. The force at the time of connecting the adapter to the body lumen occlusion force tail of Example 1 The time to recirculate the blood flow was 3 minutes 40 seconds o
[0024] 実施例 2の体内管腔閉塞用カテーテルでも同様に操作を行ったが、アダプターを 接続する時点力 血流を再行させるまでの時間は、 3分 40秒であった。  [0024] The same operation was performed with the catheter for occluding a body lumen of Example 2, but the time required to recirculate the blood force when the adapter was connected was 3 minutes and 40 seconds.
[0025] 比較例を用いて同様の操作を行ったが、アダプターを接続操作には、アダプター の蓋を開け、カテーテル近位側にあるゴールドマーカーをブルークリップの中央に入 れ、真っ直ぐに直し、ゴールドマーカーより近位側の部分をグレークリップに入れ、ァ ダプターインフレーションポートから造影剤が流れてくるまでエクステンションチューブ をフラッシュして力もアダプターを閉じ、ラッチ機構を閉じ、アダプターのダイアルノッ チを「OPEN」にするように多段階的な操作が必要でるため、血流を再行させるまで の時間は、 4分 20秒であった。  [0025] The same operation was performed using the comparative example. However, to connect the adapter, open the lid of the adapter, insert the gold marker on the proximal side of the catheter into the center of the blue clip, and straighten it. Insert the part proximal to the gold marker into the gray clip, flush the extension tube until the contrast medium flows from the adapter inflation port, close the adapter, close the latch mechanism, and open the adapter dial notch. Therefore, the time required to recirculate blood flow was 4 minutes and 20 seconds.
図面の簡単な説明  Brief Description of Drawings
[0026] [図 1]本発明に係るカテーテルシステムの実施様態を説明するためのカテーテル本 体の概略模式図である。  FIG. 1 is a schematic diagram of a catheter body for explaining an embodiment of a catheter system according to the present invention.
[図 2]本発明に係るカテーテルシステムの実施様態を説明するための概略模式図で ある。  FIG. 2 is a schematic diagram for explaining an embodiment of the catheter system according to the present invention.
[図 3]本発明に係るカテーテル本体近位部の一実施様態の概略模式図である。  FIG. 3 is a schematic diagram of one embodiment of the proximal portion of the catheter body according to the present invention.
[図 4]本発明に係るカテーテルのアダプターの一実施様態の概略模式図である。  FIG. 4 is a schematic diagram of one embodiment of a catheter adapter according to the present invention.
[図 5]本発明に係るカテーテルシステムの一実施様態の概略模式図である。  FIG. 5 is a schematic diagram of one embodiment of a catheter system according to the present invention.
[図 6]本発明に係るカテーテル本体近位部の一実施様態の概略模式図である。  FIG. 6 is a schematic diagram of one embodiment of the proximal portion of the catheter body according to the present invention.
[図 7]本発明に係るカテーテルのアダプターの一実施様態の概略模式図である。  FIG. 7 is a schematic diagram of one embodiment of a catheter adapter according to the present invention.
[図 8]本発明に係るカテーテル本体の一実施様態の概略模式図である。  FIG. 8 is a schematic diagram of one embodiment of a catheter body according to the present invention.
符号の説明  Explanation of symbols
[0027] 101 バルーン 102 メインシャフト [0027] 101 balloon 102 Main shaft
103 近位部 103 Proximal part
201 バルーン 201 balloon
202 メインシャフト  202 main shaft
204 アダプター 204 adapter
205 アダプターとシリンジ接続回路 205 Adapter and syringe connection circuit
206 シリンジ 206 syringe
302 メインシャフト  302 Main shaft
303 近位部  303 proximal
307 弁体  307 Disc
308 シーノレ面  308 Sinore side
309 近位端  309 Proximal end
310 パネ  310 panel
310 パネ固定部  310 Panel fixing part
404 アダプター  404 adapter
405 アダプターとシリンジ接続回路 405 Adapter and syringe connection circuit
412 挿入部 412 Insertion section
413 気密部材  413 Airtight member
414 カテーテル保持部分  414 Catheter holding part
415 バネ材  415 Spring material
416 部材  416 members
417 突起状の構造体  417 Protruding structure
418 先端の斜めにカットしてある部分 418 The part that is cut diagonally at the tip
419 孑し 419
420 流体通路  420 Fluid passage
425 テーパー部分  425 taper part
504 アダプター  504 adapter
505 アダプターとシリンジ接続回路 507 弁体 505 Adapter and syringe connection circuit 507 Disc
509 近位端  509 Proximal end
512 揷入部  512 inserts
513 気密部材  513 Airtight member
514 カテーテル保持部分  514 Catheter holding part
515 ノネ材  515 None
516 部材  516 members
517 突起状の構造体  517 Protruding structure
518 先端の斜めにカットしてある部分 518 The part that is cut diagonally at the tip
519 孔 519 holes
520 流体通路  520 Fluid passage
525 テーパー部分  525 taper part
602 メインシャフト  602 main shaft
603 近位部  603 Proximal part
607 弁体  607 Disc
608 シーノレ面  608 surface
609 近位端  609 Proximal end
610 ノ^ネ  610
621 突出した部分  621 Protruding part
704 アダプター  704 adapter
705 アダプターとシリンジ接続回路 705 Adapter and syringe connection circuit
712 挿入部 712 Insertion section
713 気密部材  713 Airtight member
714 カテーテル保持部分  714 Catheter holding part
715 ノ ネ材  715
716 部材  716 parts
722 押し当て構造体  722 Pushing structure
725 テーパー部分 804 アダプター 725 taper part 804 adapter
805 アダプターとシリンジ接続回路 805 Adapter and syringe connection circuit
807 弁体 807 Disc
809 近位端  809 Proximal end
812 挿入部  812 Insertion section
813 気密部材  813 Airtight material
814 カテーテル保持部分  814 Catheter holding part
815 ノネ材  815 None
816 部材  816 members
820 流体通路  820 Fluid passage
821 突出した部分  821 Protruding part
822 押し当て構造体  822 Pushing structure
825 テーパー部分  825 taper part

Claims

請求の範囲 The scope of the claims
[1] バルーンと、前記バルーンを拡張又は収縮させるための流体が移動可能なインフ レーシヨンルーメンを有する管状体と、管状体の近位部分に前記流体をシールする 流体シール部分を有するカテーテル本体と、カテーテル本体と接続されるアダプタ 一からなるカテーテルシステムであって、カテーテル本体のシール部分をアダプター に差込み挿入する操作でシールが開放状態になり、シール部分をアダプタ一力 抜 去する操作でシールが閉塞状態になることを特徴とするカテーテルシステム。  [1] A balloon, a tubular body having an inflation lumen through which fluid for expanding or deflating the balloon can move, and a catheter body having a fluid seal portion for sealing the fluid to a proximal portion of the tubular body The catheter system is composed of a single adapter connected to the catheter body. The seal is opened by inserting and inserting the seal portion of the catheter body into the adapter, and the seal is removed by removing the seal portion with one adapter. A catheter system characterized by being in an occluded state.
[2] アダプターが、シール部分を差込み挿入される挿入部を有し、挿入されるシール部 分の軸がアダプターに対し常に一定の位置で挿入されるような挿入部を有するァダ プターを含む請求項 1記載のカテーテルシステム。  [2] The adapter includes an adapter having an insertion portion that is inserted by inserting the seal portion, and an insertion portion in which the shaft of the inserted seal portion is always inserted at a fixed position with respect to the adapter. The catheter system according to claim 1.
[3] アダプターにカテーテル本体が差込み挿入された場合に、カテーテルのインフレ一 シヨンルーメンとアダプターの流体供給部の気密性を保持するためにアダプターの挿 入部中に気密部材を有することを特徴とする請求項 2記載のカテーテルシステム。 [3] When the catheter body is inserted and inserted into the adapter, an airtight member is provided in the adapter insertion portion in order to maintain the airtightness of the inflation lumen of the catheter and the fluid supply portion of the adapter. The catheter system according to claim 2.
[4] アダプターにカテーテル本体が差込み挿入された場合に、カテーテル本体とァダ プターの相対位置を固定するための保持機構をアダプターに有することを特徴とす る請求項 2から 3記載のカテーテルシステム。 [4] The catheter system according to any one of claims 2 to 3, wherein the adapter has a holding mechanism for fixing the relative position of the catheter body and the adapter when the catheter body is inserted and inserted into the adapter. .
[5] アダプターが、シール部分を挿入される挿入部を有し、該揷入部のアダプター最外 面部がテーパー状に外に開いている形状であることを特徴とする請求項 2から 4記載 の力テーテノレシステム。 [5] The adapter according to any one of claims 2 to 4, wherein the adapter has an insertion portion into which the seal portion is inserted, and the adapter outermost surface portion of the insertion portion has a shape opened outward in a tapered shape. Force tester system.
[6] アダプターが、シール部分を差込み挿入される挿入部を有し、該揷入部の断面形 状とシール部分の断面形状が相似であることを特徴とする請求項 2から 5記載のカテ ーテノレシステム。  6. The catheter system according to claim 2, wherein the adapter has an insertion portion into which the seal portion is inserted and inserted, and the cross-sectional shape of the insertion portion is similar to the cross-sectional shape of the seal portion. .
[7] アダプターの挿入部の断面形状およびカテーテル本体のシール部分の断面形状 が共に円形であることを特徴とする請求項 6記載のカテーテルシステム。  7. The catheter system according to claim 6, wherein both the cross-sectional shape of the insertion portion of the adapter and the cross-sectional shape of the seal portion of the catheter body are circular.
[8] アダプターに挿入されていない状態で閉塞状態であるように実質的に流体をシー ルする弁体力 アダプターの挿入部に取り付けられた突起状の構造体により、カテー テル本体のシール部分をアダプターに差込み挿入する操作に伴って、前記弁体が 前記アダプターの挿入部に取り付けられた突起状の構造体によって変位させられる ことによりシールが開放状態となることを特徴とする請求項 1から 7記載のカテーテル システム。 [8] Valve body force that substantially seals the fluid so that it is in a closed state when not inserted into the adapter. The protruding structure attached to the insertion part of the adapter allows the seal part of the catheter body to be The valve body is displaced by a projecting structure attached to the insertion portion of the adapter in accordance with the insertion and insertion operation. 8. The catheter system according to claim 1, wherein the seal is opened.
[9] 前記突起状の構造体が中空の筒状構造体で、内部に前記バルーンを拡張又は収 縮させるための流体を通過させる構造であることを特徴とする請求項 8記載のカテー テノレシステム。  [9] The catheter system according to claim 8, wherein the projecting structure is a hollow cylindrical structure and has a structure that allows a fluid for expanding or contracting the balloon to pass therethrough. .
[10] 前記筒状構造体の先端に斜めにカットしてある部分を有することを特徴とする請求 項 9記載のカテーテルシステム。  10. The catheter system according to claim 9, further comprising a portion that is obliquely cut at a tip of the cylindrical structure.
[11] 前記筒状構造体の側面に流体を通過させるための孔を設けてあることを特徴とする 請求項 9から 10記載のカテーテルシステム。  11. The catheter system according to claim 9, wherein a hole for allowing fluid to pass through is provided on a side surface of the cylindrical structure.
[12] アダプターに挿入されていない状態で閉塞状態であるように実質的に流体をシー ルする弁体がカテーテル外部に突出した部分を有するシール部分と、アダプターの 挿入部に配置され前記弁体のカテーテル外部に突出した部分を押すような押し当て 構造体により、カテーテル本体のシール部分をアダプターに差込み挿入する操作に 伴って、前記弁体が前記押し当て構造体によって変位させられることによりシールが 開放状態となることを特徴とする請求項 1から 7記載のカテーテルシステム。  [12] A valve body that substantially seals the fluid so as to be in a closed state when not inserted into the adapter, and a seal portion having a portion protruding to the outside of the catheter; and the valve body disposed at the insertion portion of the adapter With the pressing structure that pushes the protruding portion of the catheter to the outside, the valve body is displaced by the pressing structure as the seal portion of the catheter body is inserted and inserted into the adapter, thereby sealing the seal. The catheter system according to claim 1, wherein the catheter system is in an open state.
[13] 前記アダプターの挿入部に配置された押し当て構造体力 前記バルーンを拡張又 は収縮させるための流体を通過させることの出来るメッシュ状構造体であることを特徴 とする請求項 12記載のカテーテルシステム。  [13] The catheter structure according to claim 12, wherein the structure is a mesh-like structure capable of passing a fluid for expanding or deflating the balloon. system.
[14] 前記アダプターの挿入部に配置された押し当て構造体力 前記バルーンを拡張又 は収縮させるための流体を通過させることの出来る多孔構造体であることを特徴とす る請求項 12記載のカテーテルシステム。  [14] The catheter according to claim 12, wherein the structure is a porous structure capable of passing a fluid for expanding or deflating the balloon. system.
PCT/JP2007/050063 2006-01-11 2007-01-09 Catheter system WO2007080843A1 (en)

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JPS60501343A (en) * 1983-08-20 1985-08-22 アエロ、プムプ、ゲ−エムベ−ハ−、ツエアシユトイバプムペン Check valve for medical use, especially for balloon catheters
JPH0411043U (en) * 1990-05-18 1992-01-29
JPH09327519A (en) * 1996-03-15 1997-12-22 Becton Dickinson & Co Separation device for access device for medical use
JP2002537953A (en) * 1999-03-11 2002-11-12 アドヴァンスト カーディオヴァスキュラー システムズ インコーポレーテッド Blood regurgitation control valve
WO2005018726A1 (en) * 2003-08-12 2005-03-03 Sherwood Services Ag Valved catheter
WO2005092426A1 (en) * 2004-03-26 2005-10-06 Kaneka Corporation Catheter
US20050256461A1 (en) * 2004-05-12 2005-11-17 Difiore Attilio E Catheter with removable extension

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