JP2001204824A - Catheter straitening device and catheter assembly - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a catheter straitening device and a catheter assembly safely and easily straitening a shaped catheter and preventing an introduction port into the body, a tube wall, etc., from being damaged in inserting the straightened catheter into the body. SOLUTION: This catheter straightening device 1 for straightening the shaped catheter is constituted of a tube 2 having flexibility capable of being inserted into the catheter and a long linear body 4 capable of being inserted into the tube 2 and having the whole length longer than the tube 2. A first connector 3 installed in the proximal end of the tube 2 and a second connector 5 installed in the proximal end of the linear body 4 are provided with connecting means connected with each other.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a catheter straightening device and a catheter assembly for pre-straightening a shaped catheter before insertion into a body.

[0002]

2. Description of the Related Art In recent years, variously shaped catheters have been developed according to purposes and applications. For example, a catheter having a curved end (for example, a pigtail shape) has been developed as a device that is indwelled in a body cavity to aspirate a body fluid or inject a drug solution. A catheter having such a shape has advantages such as being less likely to deviate from the indwelling site than a catheter having a straight tip.

[0003] Shaped catheters, however, are generally more difficult to insert into the body than straight catheters.

[0004] In order to solve this problem, a device has been developed in which a shaped catheter is straightened before it is inserted into the body. Devices include a tube-shaped device made of resin and a tube-shaped device made of metal. These devices are used as follows.

[0005] First, the device is inserted into the lumen of a shaped catheter. Next, a guide wire that has been inserted in advance into a target site in the body is inserted from the distal end of the catheter that has been straightened by inserting the device. And put the catheter along the guide wire,
Advance the catheter to the target site. After the catheter reaches the target site, the device and guide wire are removed. Withdrawal of the device restores the catheter to its original shape and remains at the target site.

[0006]

However, the above device has the following problems. First, a device made of resin is flexible and has a low pushing force, so that it takes time and skill to insert it into a shaped part.
On the other hand, devices made of metal have high rigidity,
The catheter may be damaged when inserted into the shaped site, or the catheter itself may be stretched out when the device hits the shaped site. Also, after inserting the device, the catheter itself becomes hard, so when the catheter reaches the target site in the body,
There is also a problem that the inlet (the surface of the skin) into the body and the wall of the tube are easily damaged.

Accordingly, an object of the present invention is to enable a shaped catheter to be straightened safely and easily, and to introduce a straightened catheter into a body when introducing the straightened catheter into a body or a tube wall. It is an object of the present invention to provide a catheter straightening device and a catheter assembly which are safe without damaging the catheter.

[0008]

This and other objects are achieved by the present invention which is defined below as (1) to (7).

(1) A catheter straightening device for straightening a catheter at least partially shaped, comprising a flexible tube that can be inserted into the catheter, and a tube inside the tube. A linear body that can be inserted and has a longer overall length than the tube.

(2) The device for linearizing a catheter according to the above (1), wherein the linear body has a main body portion and a tip portion having lower rigidity than the main body portion.

(3) The main body and the tip end are composed of a core material and a resin layer covering the core material.
The catheter linearization device according to (2), wherein the core has a smaller outer diameter at the distal end than at the main body.

(4) The catheter linearization device according to (3), wherein a first lubricating layer is provided on at least a part of the outer surface of the resin layer.

(5) The first connector attached to the proximal end of the tube and the second connector attached to the proximal end of the linear body are provided with means capable of being connected to each other. The catheter straightening device according to any one of the above (1) to (4), which is characterized by the following.

(6) The catheter straightening vise according to any of (1) to (5), wherein a second lubricating layer is provided on at least a part of the outer surface of the tube.

(7) A catheter assembly characterized by comprising a catheter at least partially shaped and the catheter straightening device according to any one of (1) to (6).

[0016]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

FIG. 1 is a plan view showing the overall shape of a catheter straightening device of the present invention (hereinafter, referred to as the device of the present invention). FIG. 2 is a longitudinal section showing the overall shape of a linear body in the device of the present invention of FIG. FIG. 3 is a longitudinal sectional view showing a state where the first connector and the second connector are connected to each other in the device of the present invention shown in FIG. 1, and FIG. 4 is an example of a shaped catheter having a circular tip. FIG. 5 shows a top view of the catheter of FIG.
FIG. 6 is a plan view showing a state inserted into the catheter of FIG.
FIG. 4 is a plan view showing a state where a linear body has been removed from FIG. In addition,
In this specification, the left side of FIGS. 1 to 6 is described as a “proximal end” and the right side is described as a “distal end”.

The device 1 of the present invention shown in FIGS.
Is a device for straightening a shaped catheter, having a flexible tube 2 that can be inserted into the catheter, a tube 2 that can be inserted through the tube, and And a linear body 4 whose overall length is longer than 2. First, tube 2
Will be described.

The tube 2 extends from its proximal end to its distal end.
A lumen 21 is formed inside. The linear body 4 and the guide wire are inserted through the lumen 21.

Examples of the constituent material of the tube 2 include polyolefins such as polyethylene and polypropylene, polyesters such as polyethylene terephthalate and polybutylene terephthalate, fluorine resins such as polytetrafluoroethylene and ethylene-tetrafluoroethylene copolymer, and polystyrene resins. Resin, polyamide, polyurethane,
Various resins such as polyimide, polyamide elastomer,
Examples include various elastomers such as polyester elastomer, polyurethane elastomer, polystyrene elastomer, and fluorine-based elastomer, or a combination of two or more of these elastomers.

Such a tube 2 may be composed of a laminate of two or more layers, in addition to the case where the tube 2 is composed of one layer. Further, a reinforcing material may be provided in or between the layers. Examples of the reinforcing material include those formed of a linear or spiral (coiled) linear body and those formed of a net-like body.

In addition, a second lubricating layer 22 is provided on the outer surface of the tube 2 so that insertion and removal from the shaped catheter can be performed more easily and smoothly. As a constituent material of the second lubricating layer 22, for example,
Cellulose-based polymer, polyethylene oxide-based polymer, maleic anhydride-based polymer (eg, maleic anhydride copolymer such as methyl vinyl ether-maleic anhydride copolymer), acrylamide-based polymer (eg, , Polyacrylamide, polyglycidyl methacrylate-dimethylacrylamide (PGMA-DMA
A) a block copolymer), hydrophilic polymer materials such as water-soluble nylon, and silicone resins.

The outer diameter of the tube 2 is not particularly limited as long as it is smaller than the inner diameter of the catheter to be used.
It is preferably about 0.2 to 2.0 mm smaller than the inner diameter of the catheter used, and more preferably about 0.8 to 1.2 mm smaller.

The thickness of the tube 2 is not particularly limited, but is usually preferably about 0.15 to 0.5 mm.
It is more preferably about 0.2 to 0.3 mm. When the wall thickness is smaller than the above range, when a linear body 4 described later is removed from the tube 2, the used catheter cannot be kept in a straight state, and may be restored to the original shape.

The total length of the tube 2 is not particularly limited as long as it can reach the shaped portion of the catheter to be used.

At the base end of the tube 2, a first connector 3
Is installed. Since the first connector 3 functions as an insertion port of the linear body 4 and the guide wire into the tube 2, an inner cavity 31 communicating with the lumen 21 of the tube 2 is formed.

The first connector 3 also functions as a grip when the tube 2 is operated. Therefore, a pair of handles 32 is formed on the side of the first connector 3 so as to protrude.

A male screw 33 is formed on the outer periphery of the base end of the first connector 3.
Can be screwed.

Next, the configuration of the linear member 4 will be described.
The linear body 4 of the device of the invention shown in FIG. 2 has a body 41 and a lower rigidity than the body 41 so that insertion into a shaped catheter can be performed more smoothly and safely. And a tip 42.

The linear member 4 is composed of a core material 43 and a resin layer 44 covering the core material 43. The core member 43 has a uniform outer diameter in the main body portion 41, but has a distal end portion 42.
In, the outer diameter gradually decreases in a tapered shape toward the distal end side. As described above, the distal end portion 42 of the linear body 4
Since the outer diameter of the core member 43 is reduced, the rigidity is lower than that of the main body 41.

As a constituent material of the core material 43, for example, N
Examples include superelastic alloys such as i-Ti alloys, stainless steels, and various metal materials such as piano wires.

Examples of the constituent material of the resin layer 44 include polyolefins such as polyethylene and polypropylene, polyesters such as polyethylene terephthalate and polybutylene terephthalate, fluorine-based resins such as polytetrafluoroethylene and ethylene-tetrafluoroethylene copolymer, and polystyrene. Resin, polyamide, polyurethane,
Various resins such as polyimide, polyamide elastomer,
Various elastomers such as a polyester elastomer, a polyurethane elastomer, a polystyrene elastomer, and a fluorine-based elastomer are exemplified.

Further, in order to make it easier and smoother to insert and remove the tube 2 and the shaped catheter, a first surface is formed on the outer surface of the resin layer 44.
A lubrication layer 45 is provided. As a constituent material of the first lubricating layer 45, for example, a cellulose-based polymer, a polyethylene oxide-based polymer, or a maleic anhydride-based polymer (for example, an anhydride such as a methyl vinyl ether-maleic anhydride copolymer) is used. Maleic acid copolymer), acrylamide-based polymer substances (for example, polyacrylamide, block copolymer of polyglycidyl methacrylate-dimethylacrylamide (PGMA-DMAA)),
Examples include hydrophilic polymer materials such as water-soluble nylon and silicone resins.

The outer diameter of the linear body 4 is not particularly limited as long as it is smaller than the inner diameter of the tube 2, but is usually preferably about 0.05 to 0.5 mm smaller than the inner diameter of the tube 2, More preferably, it is smaller by about 1 mm.

The total length of the linear body 4 is not particularly limited as long as it is longer than the entire length of the tube 2, but it is usually preferably about 100 to 500 mm longer than the entire length of the tube 2.
More preferably, the length is about 150 to 250 mm.

At the base end of the linear body 4, a second connector 5 is mounted. The second connector 5 is a member in which the inner cylinder 51 and the outer cylinder 52 are arranged concentrically. The linear body 4 is inserted into the inner cylinder 51, and the inner cylinder 51 is bonded by a method such as bonding.
It is fixed to. The outer cylinder 52 is a member that functions as a grip for operating the linear body 4. The outer cylinder 52 and the inner cylinder 51 are connected and integrated at their base ends.

On the inner periphery of the outer cylinder 51, the male screw 3
A female screw 53 that can be screwed with 3 is formed.

Next, an example of a method of using the device 1 of the present invention will be described.

First, as shown in FIG. 1, the linear body 4 is inserted through the lumen 21 of the tube 2. Then, as shown in FIG. 3, the male screw 33 and the female screw 53 are screwed together to connect the first connector 3 and the second connector 5. Due to the connection, the tube 2 and the linear body 4 are integrated and can be operated at the same time. Further, when they are connected, the distal end of the linear body 4 projects from the distal end opening of the tube 2.

The device 1 thus assembled
Is inserted from the hub 8 attached to the proximal end of the catheter 6 whose distal end is curved in an arc shape as shown in FIG. The tip 4 of the linear body 4 reaching the curved portion 7 of the catheter 6 first
2 has a lower rigidity than the main body 41, and thus follows the curved portion 7 safely and smoothly. Then, the tube 2 reaches the curved portion 7, and the curved portion 7 is straightened. The tube 2 is easily inserted into the curved portion 7 because the linear body 4 is inserted into the lumen 21 and the pushing force is increased.
When the constituent materials of the second lubricating layer 22 and the first lubricating layer 45 are hydrophilic polymer materials, the device 1 is connected to the catheter 6.
If it is immersed in a physiological saline solution before inserting it into the
Since the tube 2 and the linear body 4 are provided with lubricity, insertion of the device 1 into the curved portion 7 is further facilitated.

Then, as shown in FIG. 5, after the tube 2 is completely inserted into the curved portion 7, the first connector 33
Remove the second connector 53 from the connector. Then, the linear body 4 is removed from the first connector 33. As shown in FIG. 6, when the linear body 4 is removed, the tube 2 is left in the catheter 6, so that the curved portion 7 is maintained in a substantially straight state.

Next, a guide wire is inserted percutaneously to a target site in the body (a site where a catheter is to be placed). Then, a guide wire is inserted from the distal end of the catheter 6, which is maintained in a substantially straight state shown in FIG. Then, the catheter 6 is advanced along the guide wire and guided to a target site.

After the catheter 6 reaches the target site, the tube 2 is removed from the hub 8. Thereafter, the guide wire is also removed. By removing the tube 2 and the guide wire, the curved portion 7 of the catheter 6 is restored to the original shape shown in FIG. 4, and is placed at the target portion.

As described above, the present invention has been described based on the embodiments. However, it is needless to say that the present invention is not limited to these embodiments, and that the configuration of each unit can be replaced with any configuration capable of exhibiting the same function. it can.

In the above, the case where the device of the present invention is used for a catheter whose tip is curved in an arc has been described. However, the present invention is not limited to this, and for example, an indwelling catheter having a curved intermediate portion, It can also be used to straighten indwelling catheters in the form of loops, angiographic catheters in the form of Jatkins, amplats, and PTCA guiding catheters.

[0046]

As described above, the catheter straightening device of the present invention is a catheter straightening device for straightening a catheter at least partially shaped, and can be inserted into the catheter. A flexible tube, which is capable of being inserted through the tube, and is characterized by being constituted by a linear body having a longer overall length than the tube,
The shaped catheter can be safely straightened without damaging or stretching the shaped site. Further, insertion into the shaped catheter can be performed smoothly and easily. Further, when the straightened catheter is inserted into the body, the catheter is safe without damaging the introduction port into the body or the tube wall.

In the case where the linear body has a main body and a distal end having a lower rigidity than the main body, when the shaped catheter is straightened, the safety is further improved. .

Further, the main body portion and the tip portion are composed of a core material and a resin layer covering the core material,
When the core material has an outer diameter smaller than that of the main body at the distal end, the distal end of the linear body is inserted into the shaped catheter when the catheter straightening device is inserted into the catheter. Since it easily follows the shaped part, the easiness and safety are further improved.

Further, when a first lubricating layer is provided on at least a part of the outer surface of the resin layer, insertion / removal into / from a tube and a shaped catheter can be performed more easily and smoothly. Can be.

In the case where the first connector attached to the proximal end of the tube and the second connector attached to the proximal end of the linear body are provided with a means capable of connecting with each other, Since the tube and the linear body are integrated and can be operated simultaneously, the insertion into the shaped catheter is further facilitated.

When at least a part of the outer surface of the tube has a second lubricating layer, insertion and removal from the shaped catheter becomes easier.

[Brief description of the drawings]

FIG. 1 is a plan view showing the overall shape of a catheter straightening device of the present invention.

FIG. 2 is a longitudinal sectional view showing the overall shape of a linear body in the catheter straightening device of FIG.

FIG. 3 is a longitudinal sectional view showing a state where a first connector and a second connector are connected to each other in the catheter straightening device of FIG. 1;

FIG. 4 is a plan view showing a catheter whose tip is curved in an arc as an example of a shaped catheter.

5 is a plan view showing a state where the catheter straightening device of FIG. 1 is inserted into the catheter of FIG. 4;

FIG. 6 is a plan view showing a state where a linear body is removed from FIG. 5;

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Catheter straightening device 2 Tube 21 Lumen 22 Second lubrication layer 3 First connector 31 Lumen 32 Handle 33 Male screw 4 Linear body 41 Main body 42 Tip part 43 Core material 44 Resin layer 45 First lubrication layer 5 Second Connector 51 Inner tube 52 Outer tube 53 Female screw 6 Catheter 7 Bending part 8 Hub

Claims (7)

[Claims] 1. A catheter straightening device for straightening a catheter at least partially shaped, comprising: a flexible tube that can be inserted into the catheter; And a linear body having a longer overall length than the tube. 2. The catheter straightening device according to claim 1, wherein the linear body has a main body and a distal end having lower rigidity than the main body. 3. The main body and the distal end portion are composed of a core material and a resin layer covering the core material, and the core material has an outer diameter at the distal end portion that is smaller than that of the main body portion. 3. The catheter straightening device of claim 2, wherein the device is reduced. 4. The method according to claim 1, wherein at least a part of the outer surface of the resin layer is
The catheter straightening device according to claim 3, comprising a first lubricating layer. 5. The method according to claim 1, wherein the first connector attached to the proximal end of the tube and the second connector attached to the proximal end of the linear body have coupling means capable of coupling with each other. A catheter straightening device according to any of the preceding claims. 6. A tube according to claim 1, further comprising a second lubricating layer on at least a part of an outer surface of said tube.
6. The device for linearizing a catheter according to any one of claims 5 to 5. 7. A catheter assembly comprising at least a partly shaped catheter and a catheter straightening device according to any one of claims 1 to 6.