JP2002291868A - Thrombus aspirator - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a tool to easily, safely and reliably aspirate stagnating matter such as a thrombus in the interior of a tool for introducing into a biological duct such as a sheath introducer and a combination of the tool and the sheath introducer to remove a thrombus while confirming presence of the thrombus. SOLUTION: The thrombus aspirator has a body portion having an engagement portion with the tip of a syringe and an insertion portion inserted into the interior of the sheath introducer, and at least a part of which is transparent and the inside diameter is 1 to 4 mm.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a jig for sucking stagnant substances inside a device for introducing a medical device into a living body tube.

2. Description of the Related Art In general, a catheter is guided by a guide wire and inserted into a tubular organ such as a blood vessel. After a distal end of the catheter reaches a target site, for example, a contrast agent or the like is administered to perform various tests. It is used for collecting tissue of an affected part through a forceps or the like inside, inserting a member such as a stent, and placing the member.

As shown in FIG. 2, a sheath introducer, which is a tool for introducing these guide wires and catheters into a blood vessel, is a sealing means for preventing body fluid from flowing out when blood is not inserted when a catheter or the like is inserted or withdrawn. valve)
6 are provided so that the catheter can be easily replaced or exchanged.

However, when a catheter or guidewire is left in a blood vessel for a long time, a thrombus layer is formed on the surface of the catheter or guidewire. If the catheter or guide wire is removed as it is, most of the thrombus adhering to the catheter or guide wire surface when passing through the hemostatic valve is stopped by the hemostatic valve and stays in the hub interior 8. Therefore,
Even when thrombus is not adhered to the surface of the extracted catheter or guide wire, thrombus often actually adheres. In the case where the sheath introducer is also immediately removed after the catheter or guide wire is removed, there is no danger that the thrombus staying inside the sheath introducer hub 8 will return to the body, but the sheath introducer is left for a long time, and again When a catheter is inserted, there is a danger that thrombus staying inside the sheath introducer hub 8 will be pushed out into the body. Normally, the retained blood is once suctioned and removed from the side port tube 1 branched from the sheath introducer hub 5 so that the blood inside the sheath introducer does not coagulate during the indwelling, and then the blood such as heparin is removed therefrom. Blood coagulation prevention measures such as filling the sheath with an anticoagulant, a thrombolytic agent and the like are taken.

[0004] However, the above-described means requires a considerable amount of time to remove the thrombus that has accumulated and stayed inside the sheath introducer hub 8, and has problems such as incomplete thrombus dissolution. Despite this situation,
Until now, there is no device for aspirating and removing thrombus remaining in the sheath introducer interior 8.

[0005]

A jig for easily, safely and surely sucking and removing a stagnant substance such as a thrombus inside a device for introduction into a living body tube such as a sheath introducer,
And a combination of the jig with a sheath introducer to help remove the thrombus while confirming its presence.

[0006]

Means for Solving the Problems As a result of intensive studies, the present inventors have found that a medical device having the following structure solves the above-mentioned problems and achieves the object, and has completed the present invention. That is, the present invention relates to a thrombus suction device which, in combination with a syringe, suctions a thrombus staying inside a hub of a sheath introducer, and has a main body having a fitting portion with a syringe tip and an insertion to be inserted into the sheath introducer. With a thrombus suction device comprising a portion, at least a part of the thrombus suction device is transparent, the inner diameter of the insertion portion is 1 to 4 mm, a sheath having a lumen communicating from the front end to the rear end, It is a thrombus suction tool which has a transparent hub having a hollow structure and is used in combination with a sheath introducer having a side port branched from the hub.

[0007]

Embodiments of the present invention will be described below with reference to the drawings. FIG. 3 shows an embodiment of the present invention. 29 is a main body for confirming the sucked thrombus, 30 is an insertion part which penetrates the hemostatic valve rubber of the sheath introducer and is inserted into the hub, and 31 is a fitting part with the syringe.

The thrombus suction device of the present invention is used as shown in FIG. That is, after attaching the syringe to the fitting portion 31, the insertion portion 30 of the thrombus suction tool is inserted into the hub through the hemostatic valve rubber 6 of the sheath introducer,
The thrombus 15, 16 inside or near the hub is aspirated. The thrombus suction device has a distal end shown in FIG. 7 or 8 described later, and the insertion portion 30 is thinner than the main body. The whole or at least a part of the thrombus suction device has a viewing region made of a transparent or translucent material.

The inner diameter of the insertion portion 30 of the thrombus suction device is 1 to 4
mm, preferably 1-2 mm, more preferably 1.2-1.5 mm. The outer diameter can be up to 5 mm, but is more preferably 3 to 4 mm.

The distal end of the insertion portion may be tapered, chamfered or rounded as shown in FIG. Further, as shown in FIG. 5B, one or more slits may be provided so that a large thrombus can be sucked while tearing. The width of the slit is from 1/4 to 2/3 of the diameter of the tube constituting the suction section, and the depth is also 1
It is desirable to set it in the range of / 4 to 3/4, but it is not limited to this value. Also, as shown in FIG. 5C, even if the thrombus is rather large, the inside diameter of the distal end portion is divergent, that is, the diameter is reduced toward the hand side from the suction port, as shown in FIG. Good. The angle is not particularly limited, but is preferably in the range of 30 to 60 degrees, and more preferably 40 to 50 degrees.

Further, the suction port of the thrombus suction tool may be a side hole as shown in FIG. FIG. 7 shows the thrombus suction device of the present invention.
As described above, the body part including the insertion part 30 and the fitting part can be separated.

The suction aid is preferably made of a polypropylene resin (PP), a polycarbonate resin (PC), a polyethylene resin (PE), a polyester styrene terephthalate resin (PE).
It is made of a transparent or translucent material such as T), acrylic resin, acrylic styrene resin (AS), vinyl chloride resin (PVC), polymethylpentene resin (TPX). It may be colored for identification to make sure the application is correct.

The present invention is directed to FIG.
And a thrombus suction device used in combination with a sheath introducer having a transparent hub 5a as shown in FIG. Because the sheath introducer is a hub with visibility,
It can be performed while confirming whether or not the thrombus has been completely removed.

[0015] The transparent material of the hub of the sheath introducer having a transparent hub includes polyethylene terephthalate resin (PET), polycarbonate resin (PC), polyamide resin (PA), polymethylpentene resin (TPX),
Examples thereof include polypropylene resin (PP).

FIGS. 9 and 10 show another sheath introducer used in combination with the present thrombus suction device. The side port tube of FIG. 9 is a thick sheath introducer and the sheath introducer of FIG. 10 with the side port angled. The hub 5a of these sheath introducers is also transparent. The inner diameter of the large side port is 1.5 to 4 mm.

The material of the branch tube is not particularly limited as long as it is used for medical purposes, but preferably has a material surface on which thrombus formation is difficult. Soft polyvinyl chloride resin, polyurethane resin, 1-2 polybutadiene resin and the like are preferable, and those having an inner surface coated with antithrombotic properties, water lubricity and the like may be used.

The sheath tube and the dilator are made of tetrafluoroethylene hexafluoropropylene resin (FEP), ethylene tetrafluoroethylene copolymer resin (ETFE), perfluoroalkoxy resin (PF
A), fluororesin such as polytetrafluoroethylene resin (PTFE), polyvinyl fluoride resin (PVDF), polyamide resin such as nylon 11, nylon 12, polyether block amide resin (PEBA), polyethylene (PE), etc. Can be used. These materials may be formed in a multilayer or a combination of two or more resins. Further, in the sheath tube, a reinforcing layer formed in a linear shape, a mesh shape, or a coil shape with a metal wire, a fiber, or the like may be provided. Further, the distal end of the sheath tube or the dilator may contain an X-ray opaque substance such as gold, platinum, tungsten, and bismuth.

The material of the body fluid back-flow sealing means (hemostatic valve 6) may be natural rubber, silicone resin or the like.

The material (opaque material) of the ordinary introducer hub 5 is polyacetal resin (PO
M), ABS resin, polyethylene resin (PE) and the like. Examples of the material of the sheath tube kink preventing member 13 include soft vinyl chloride resin (PVC), polyether block amide resin (PEBA), polyurethane resin (PU), polypropylene elastomer resin, and styrene elastomer resin.

The lubricity of the surfaces of the sheath tube and the dilator may be determined, for example, by coating silicone oil, glycerin, etc. on the surface, coating the surface with a low friction material such as silicone coat, fluororesin coat, etc., and using starch, polysaccharide, etc. Coating of natural polymers, polyvinyl alcohol, polyvinyl pyrrolidone, polyethylene glycol, maleic anhydride polymer, methyl vinyl ether maleic anhydride copolymer, acrylic acid, methacrylic acid and its derivatives, hydrophilic polymers such as acrylamide And the like by low friction treatment and surface lubricity treatment.

The treatment of the surface of the sheath tube for antithrombotic property is described in TD disclosed in JP-A-10-323386.
Application of a MAC-containing heparin solution, a coating composition disclosed in JP-A-62-558, or the like;
No. 744155 discloses a vinyl graft block composed of a vinyl monomer unit (a) as a hydrophilic portion and a fluorinated vinyl monomer unit (b) as a hydrophobic portion. Covalently bonding a hydrophilic compound with a vinyl-based graft / block copolymer having a hydrolyzed silyl group (c) at least at one end, and further subjecting it to an alkali treatment (Patent Publication 269)
No. 6053). It is also possible to use known techniques other than these.

[0023]

According to the thrombus suction device of the present invention, the thrombus staying inside the hub of the sheath introducer can be easily, safely and surely removed.

[Brief description of the drawings]

FIG. 1 is a diagram illustrating suction of a thrombus from inside a hub using only a conventional side port tube.

FIG. 2 shows a sheath introducer hub inner portion 8 and a sheath tube assembling portion 9 to which thrombus usually tends to adhere.

FIG. 3 is a thrombus suction device of the present invention.

FIG. 4 is a view showing a method of using the thrombus suction device of the present invention.

FIG. 5 (A): The thrombus suction device of the present invention having a tapered distal end. (B): The thrombus suction device of the present invention in which a slit is provided at the suction port at the tip. (C): The thrombus suction device of the present invention in which the lumen at the distal end is flared.

FIG. 6 is a thrombus suction device of the present invention in which a suction port is a side hole.

FIG. 7 is a thrombus suction device of the present invention in which a main body portion and a fitting portion can be separated.

FIG. 8 shows a combination of a sheath introducer having a transparent hub and a thrombus suction device included in the present invention.

FIG. 9 is a sheath introducer having a thick side port used in combination with a thrombus suction device included in the present invention.

FIG. 10 is a sheath introducer having an angled side port for use in combination with a thrombus aspirator included in the present invention.

[Explanation of symbols] [Explanation of symbols]

1. Side port tube 2. Three-way cock 3. Stopcock cap 4. Syringe 5. Sheath introducer hub 5a. Sheath introducer transparent hub 6. 6. hemostatic valve rubber Hemostatic valve cap 8. 8. Inside sheath introducer hub Sheath tube assembly section 10. Thrombus suction device 11. Dilator 12. Sheath introducer 13. 13. Sheath tube kink prevention member Sheath tube 15. 13. Thrombus adhering to sheath tube assembly Thrombus attached inside sheath introducer hub 17. 17. Tip of tapered insertion section Suction port slit 19. 26. Lumen of distal end of flared insertion portion Side hole suction port 27. Side port 28. Connecting part 29. Main body 30. Insertion part 31. Fitting portion

Claims (5)

[Claims] 1. A thrombus suction device for sucking a thrombus that stays inside a hub of a sheath introducer in combination with a syringe, wherein the main body has a fitting portion with a tip of the syringe and an insertion to be inserted into the sheath introducer. Part, at least a part of the thrombus suction tool is transparent,
A thrombus suction device, wherein the inner diameter of the insertion portion is 1 to 4 mm. 2. The thrombus according to claim 1, wherein the distal end of the insertion portion is tapered, the lumen of the distal end of the insertion portion is divergent, or the insertion portion has a slit in a suction port. Suction tool. 3. The thrombus suction device according to claim 1, wherein the main body portion including the insertion portion and the fitting portion are separable. 4. A sheath introducer having a lumen having a lumen communicating from a front end to a rear end, a transparent hub having a hollow structure, and a sheath introducer having a side port branched from the hub. The thrombus suction device according to any one of the above items. 5. The thrombus suction device according to claim 4, wherein the thrombus suction device is used in combination with a sheath introducer having an inner diameter of the side port of 1.5 to 4 mm.