JP4526608B2 - Introducer sheath - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to an introducer sheath used for introducing an angiographic catheter or a therapeutic catheter into a living body lumen, particularly into a blood vessel.
[0002]
[Prior art]
A conventional introducer sheath is composed of a sheath having a hollow structure continuous from a proximal end portion to a distal end portion, and a hollow structure hub attached to the proximal end portion of the sheath. This introducer sheath has been conventionally used for transcutaneously introducing a contrast catheter or a treatment catheter used for diagnosis of blood vessels and organs into a blood vessel. It is also used for guiding catheters.
[0003]
When this introducer sheath is used to introduce a catheter into a blood vessel, the following method is used. First, a Seldinger needle was punctured into an artery or vein, a guide wire was inserted into the blood vessel through the Seldinger needle, the Seldinger needle was removed leaving the guide wire, and a dilator was inserted and set around the remaining guide wire Introduce the introducer sheath into the blood vessel so that the introducer sheath is covered, leave the introducer sheath in the blood vessel, remove the guide wire and dilator, and place the introducer sheath in the artery or vein To do. In order to prevent blood coagulation in the sheath during indwelling, work to fill from the three-way stopcock to the tip of the sheath with heparinized diet, and the catheter is inserted into and removed from the blood vessel through the placed introducer sheath. It has been known. In addition, it is necessary to taper the tip of the introducer sheath so that it can be easily introduced into a living body or blood vessel.
[0004]
In these techniques, a catheter is introduced into a patient's blood vessel to perform observation, treatment, and the like, and thus a method such as blood pressure electrocardiogram measurement is taken to grasp the patient's condition as needed.
[0005]
In the case of measuring this blood pressure electrocardiogram, conventionally, the blood pressure electrocardiogram due to blood inflow from the gap between the introduced catheter and the sheath tip has been measured.
[0006]
[Problems to be solved by the invention]
However, when a blood pressure electrocardiogram is measured from the sheath tip, a sufficient blood pressure electrocardiogram cannot be measured unless there is a difference in the outer diameter of the catheter and the inner diameter of the sheath tip. Therefore, the setting of the sheath tip inner diameter requires an inner diameter of + α, which is the maximum outer diameter of the catheters sold from a plurality of manufacturers. Therefore, when an accurate blood pressure electrocardiogram from the distal end of the sheath is to be measured, the outer diameter of the sheath inevitably increases as the inner diameter of the distal end increases.
[0007]
On the other hand, considering shortening of the postoperative hemostasis time and recovery of the patient, it is better that the perforation in the living body when introducing the blood vessel into the sheath is smaller, and therefore a smaller sheath outer diameter is required.
[0008]
The objective of this invention is providing the introducer sheath which provided the side hole in the specific position in order to measure a blood pressure electrocardiogram, without enlarging a sheath outer diameter.
[0009]
[Means for Solving the Problems]
In order to solve the above-described problems, an introducer sheath according to the present invention includes an introducer sheath comprising a sheath having a hollow structure continuous from a base end portion to a tip end portion, and a hub attached to the base end portion of the sheath. The sheath has a tapered portion at the tip that narrows the gap between the straight portion of the main body and the introduced catheter, which can secure a gap where stable blood can flow when the catheter is introduced into the sheath, The side hole which takes in blood is arrange | positioned within the range of 3-10 mm from the front-end | tip of the side wall of the straight part of this sheath, It is characterized by the above-mentioned.
[0010]
Moreover, it is preferable that the diameter of the side hole provided in the side wall of the said sheath is 0.8 mm or less.
[0011]
In addition, the number of side holes provided in the sheath is at least two, and in the case of two, it is preferable that the side holes are arranged 180 degrees away from the axial direction.
[0012]
Moreover, it is preferable that the hub has a valve body in the hub, and has a branching channel and a branch channel communicating from the branching unit on the tip side of the valve body.
[0013]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, the introducer sheath of the present invention will be described with reference to the accompanying drawings.
[0014]
FIG. 1 is a view showing an embodiment of an introducer sheath of the present invention.
[0015]
The introducer sheath 1 of the present invention includes a sheath 13 having a hollow structure continuous from a base end portion 11 to a tip end portion 12 and a hub 14 having a hollow structure and attached to the base end portion 11 of the sheath 13. A side hole 16 is provided in the sheath side wall.
[0016]
The introducer sheath 1 has a straight portion 22 forming a main body portion and a tapered portion 15 provided at the tip of the straight portion 22. The tapered portion 15 is tapered toward the tip so that it can be easily introduced when introduced into the living body.
[0017]
The side holes 16 are provided not in the tapered portion 15 but in the straight portion 22. When the side hole is provided in the tapered portion 15, the gap with the introduced catheter becomes narrow and blood inflow becomes difficult. Therefore, in order to measure the blood pressure electrocardiogram more reliably, the gap that allows stable blood inflow Is preferably provided on the straight portion 22 of the sheath 13.
[0018]
The hub 14 is provided with a blood pressure electrocardiogram measurement line as a branch pipe 17 communicating with the valve body 19, the branch part 21, and the branch part 21, and a three-way cock 18 is provided at the base end part thereof. At the time of indwelling, heparinized raw food is injected from the three-way cock 18 to prevent blood coagulation in the sheath, and the sheath tip is filled.
[0019]
The branch pipe 17 is provided on the distal end side of the valve body so that the liquid flows into the blood pressure measurement line which is the branch pipe 17 without leaking from the hub proximal end even when the blood flows in along the gap with the catheter. Has been.
[0020]
In the embodiment shown in FIG. 1, the hub 14 is attached to the sheath 13 by being inserted into a support 20 for preventing the kink (bending) of the sheath 13. However, the attachment structure of the hub 14 and the sheath 13 is not limited to this. For example, the distal end portion of the hub 14 is inserted into the opening of the proximal end portion 11 of the sheath 13 and attached to the sheath 13. It may be.
[0021]
In addition, it is indirectly connected between the sheath and the hub through an elastic member such as silicon, rubber, thermoplastic elastomer, or a tube made of silicon, butyl rubber, polyvinyl chloride, polybutadiene, polyurethane, or the like. Sometimes it is.
[0022]
Further, the hub is provided with, for example, a support 20 for preventing kinking (bending) of the sheath as a distal end side or a separate member. In addition, a groove portion and / or a ring-shaped thread hanging piece for applying a suture may be provided for suturing in order to retain the hub in the patient after securing the blood vessel.
[0023]
The material used as the sheath support 20 is preferably a styrene-based, olefin-based, or polyester-based thermoplastic elastomer from the viewpoint of preventing kinking of the sheath body.
[0024]
The material of the sheath 13 is preferably a material that has a certain degree of rigidity for introduction into the blood vessel, and that can take a large internal lumen, that is, can be thinned. Moreover, in order to percutaneously place in a blood vessel, it is necessary to have excellent biocompatibility. Considering these points, it is formed of a fluororesin, a polyethylene resin, a polypropylene resin, a polyester-based elastomer or the like.
[0025]
It is more preferable that the sheath 13 contains an X-ray contrast material such as bismuth oxide or tungsten at the time of molding in order to confirm the blood vessel introduction position.
[0026]
In the embodiment shown in FIG. 1, the hub 14 is formed of a synthetic resin. The synthetic resin may be formed of, for example, a polyethylene resin, a polypropylene resin, a polyamide resin, a polycarbonate resin, a polystyrene resin, or the like. preferable.
[0027]
Moreover, you may coat | cover the inner surface or outer surface of the said sheath 13 and the hub 14 with an antithrombogenic resin thin film. Thereby, it can be set as the introducer sheath excellent in biocompatibility. As the antithrombotic resin for coating the inner or outer surface of the sheath 13, various conventionally known resins can be used alone or in combination. For example, polyhydroxyethyl methacrylate, hydroxyethyl methacrylate and styrene can be used together. A polymer (for example, HEMA-St-HEMA block copolymer) etc. can be used conveniently.
[0028]
A valve body 19 is provided at the proximal end portion of the hub 14 so that blood and liquid do not leak. The valve body is not particularly limited, but is preferably formed of silicon, latex, butyl rubber, isoprene rubber or the like. This valve body is a cruciform slit on one side and the other side and intersects only inside, but if it is a valve body that does not leak blood or liquid, it is a multi-layered Y-shaped slit Alternatively, it may be a cross, a single-slit duck bill valve, or any other known valve body.
[0029]
The outer diameter of the introducer sheath is not particularly limited, but is usually preferably about 0.8 mm to 11 mm, and more preferably about 1.0 to 5.0 mm. The inner diameter of the sheath is not particularly limited, but is preferably about 0.7 to 10 mm, and preferably about 0.9 mm to 4.7 mm. The thickness of the sheath is not particularly limited, but is usually preferably about 0.1 to 0.3 mm, and more preferably about 0.1 to 0.25 mm.
[0030]
The length of the introducer sheath is not particularly limited, but is preferably about 10 to 300 mm, and more preferably about 50 to 150 mm.
[0031]
The side hole 16 preferably has a side hole diameter of about 0.1 to 0.8 mm, and more preferably about 0.2 to 0.8 mm.
[0032]
This size is not only difficult to resist when puncturing a living body, but also effective in preventing strength reduction and kinking due to the side holes.
[0033]
Further, the number of side holes is preferably 1 to 10, more preferably 1 to 4.
[0034]
The method of forming the side holes 16 is not particularly limited, and the side holes 16 can be formed by machining or laser processing. However, in this embodiment, since the number of side holes is small, a hole called a punch that is economically preferable. I went with the instrument.
[0035]
Although the formation part of the side hole 16 is not specifically limited if it is not the front-end | tip taper part 15 of the sheath 13, About 3-50 mm is preferable from a front-end | tip, and about 3-10 mm is more preferable.
[0036]
FIG. 2 shows a cross-sectional view of the side hole forming portion of the sheath 13. Two side holes of the introducer sheath of the present embodiment are provided at opposing positions. The arrangement in the case of forming a plurality of side holes is not particularly limited, and it is possible to arrange the side holes in parallel in the axial direction, but it is preferable to dispose them in the circumferential direction. The preferred arrangement of the plurality of side holes is preferably arranged so as to be shifted by 45 to 270 degrees with respect to the axial direction from one side hole. It is more preferable that they are arranged 90 to 180 degrees apart. In this embodiment, the two side holes are arranged to be opposed to each other, that is, shifted by 180 degrees. As a result, the inflow direction of blood is not limited, so that blood pressure electrocardiogram can be measured even when one side hole is blocked by contact with a blood vessel wall or the like.
[0037]
Next, an actual work state diagram is schematically shown in FIG. The introducer sheath 1 is punctured into the living body 100 and reaches the blood vessel 110. The catheter 30 is introduced into the introducer sheath 1 and is in a state of performing an operation such as treatment. In this state, blood flows from the side hole 16 into the introducer sheath of the present invention, and a blood pressure electrocardiogram is measured at any time from a blood pressure electrocardiogram measurement line 17 by a blood pressure electrocardiograph. FIG. 4 shows a cross section of the side hole forming portion of FIG. As described above, since the side hole is provided in the straight portion of the introducer 1, a gap with the introduced catheter is ensured, and sufficient blood can flow from the side hole. Measurement is possible.
[0038]
【The invention's effect】
The introducer sheath of the present invention is an introducer sheath comprising a sheath having a hollow structure continuous from a proximal end portion to a distal end portion, and a hub attached to the proximal end portion of the sheath, wherein the sheath is a sheath When the catheter is introduced inside, it has a taper portion at the tip which narrows the gap between the straight portion of the main body and the introduced catheter, which can secure a gap where stable blood can flow in, and the side wall of the straight portion of the sheath A side hole for taking in blood is arranged on the side wall of the straight portion within a range of 3 to 10 mm from the tip . For this reason, the gap | interval of the introduce | transduced catheter can fully be ensured and the measurement of an accurate electrocardiogram is possible.
[0039]
Moreover, since the diameter of the side hole provided in the side wall of the sheath is formed to be 0.8 mm or less, it is also effective in preventing kinks without reducing the strength of the side hole of the sheath as compared with the case where a large side hole is made. Is.
[0040]
In addition, there are at least two side holes provided in the sheath, and in the case of two, since the side holes are arranged 180 degrees away from the axial direction, the inflow direction of blood is not limited, In the unlikely event that one side hole is in contact with a blood vessel wall or the like, the blood pressure electrocardiogram can be measured.
[0041]
Further, since the hub has a valve body in the hub and has a branching portion and a branch channel communicating from the branching portion on the tip side of the valve body, the liquid is filled in the blood pressure electrocardiogram measurement line 17. Thus, liquid does not leak from the proximal end of the hub, and accurate blood pressure electrocardiogram measurement can be performed.
[Brief description of the drawings]
FIG. 1 is a diagram showing an introducer sheath of the present invention.
2 is a view showing a cross section of the side hole forming portion of FIG. 1. FIG.
FIG. 3 is a state diagram in which blood pressure electrocardiogram measurement is performed using the introducer sheath of the present invention.
4 is a view showing a cross-section of the side hole forming part of FIG. 3;
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Introducer sheath 11 Base end part 12 Tip part 13 Sheath 14 Hub 15 Tapered part 16 Side hole 17 Branching flow path (blood pressure electrocardiogram measurement line)
18 Three-way stopcock 19 Valve part 20 Support part 21 Branch pipe 22 Straight part 30 Catheter

Claims (4)

An introducer sheath comprising a sheath having a hollow structure continuous from the proximal end portion to the distal end portion, and a hub attached to the proximal end portion of the sheath, wherein the sheath introduces a catheter inside the sheath, It has a taper portion at the tip that narrows the gap between the straight portion of the main body that can secure a stable blood inflow and the introduced catheter, and is within a range of 3 to 10 mm from the tip of the side wall of the straight portion of the sheath a, b down Toro sheath that is characterized in that side holes for taking blood is disposed.   The introducer sheath according to claim 1, wherein a diameter of a side hole provided in a side wall of the sheath is 0.8 mm or less. 3. The intro according to claim 1, wherein at least two side holes are provided in the sheath, and in the case of two , the side holes are arranged to be shifted by 180 degrees with respect to the axial direction. Deusa sheath.   The introducer sheath according to any one of claims 1 to 3, wherein the hub has a valve body in the hub, and has a branch portion and a branch channel communicating from the branch portion on the tip side of the valve body. .

Images