JP2000279534A - Balloon catheter device and balloon catheter system - Google Patents

Abstract

(57) [Problem] To provide a balloon catheter system capable of replacing a dilatation balloon catheter in a state where a balloon is inflated on a peripheral side of a blood vessel part to be dilated. SOLUTION: The catheter 10 and the catheter 10
A balloon mechanism 20 attached to the distal end 11 of the catheter 10 and a chuck mechanism for holding the rear end 12 of the catheter 10;
With this chuck mechanism, the injection port 30 detachably attached to the rear end portion 12 of the catheter 10 and the lumen of the catheter 10 so as to air-tightly or liquid-tightly close the rear end opening 12A of the catheter 10. It has a tip portion 41 to be inserted, and has a shaft 40 connected to the rear end portion 12 of the catheter 10 by inserting the tip portion 41 into the lumen.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a balloon catheter device and a balloon catheter system, and more particularly, to a balloon catheter device which can be suitably used as a balloon catheter for distal protection during endovascular surgery. The present invention relates to a balloon catheter system in which such a balloon catheter device is inserted into a lumen of a dilatation balloon catheter.

[0002]

2. Description of the Related Art As an intravascular operation for a stenotic blood vessel site where cholesterol or the like adheres to an inner wall, a technique called PTA for restoring blood flow by expanding the blood vessel with a balloon catheter has been performed. Also, in order to prevent re-narrowing of the expanded blood vessel, a technique called stenting for placing a net-like pipe (stent) is performed. A balloon catheter (a balloon catheter for placing a stent and a balloon catheter for expanding a stent) is also used as a means.

[0003] However, in PTA and stenting in an artery connected to the head and neck, cholesterol clumps and thrombus adhering to the inner wall of the blood vessel are released during vasodilation, and these released substances are released into the peripheral blood vessels of the brain. Many cases have been reported in which an embolus is formed in a blood vessel, thereby leaving a neurological symptom in a postoperative patient.

[0004] As a means for preventing such side effects associated with PTA and stenting, PTA is used.
Protection that is inserted into the lumen of a balloon catheter such as a balloon catheter for stent placement, a balloon catheter for stent placement, a balloon catheter for stent expansion (hereinafter collectively referred to as a “balloon catheter for expansion”), and used.
balloon catheter device (hereinafter also simply referred to as “protection balloon catheter device”).
Has been proposed.

FIG. 1 is an explanatory view showing a state in which a balloon catheter device for protection and a balloon catheter device for PTA are combined. In FIG. 1, reference numeral 1 denotes a protection balloon catheter device. The protection balloon catheter device 1 includes a catheter 2, a protection balloon 3, and an injection port 4.
It has. Reference numeral 5 denotes a PTA balloon catheter device. The PTA balloon catheter device 5 includes a catheter 6, a PTA balloon 7, and an injection port 8 with a side arm. As shown in FIG. 1, this protection balloon catheter device 1
Is inserted into the lumen of the PTA balloon catheter device 5 and used as a child catheter.

FIGS. 2 (1) to 2 (3) show P which is performed using the balloon catheter device for protection shown in FIG.
It is explanatory drawing which shows the procedure of TA typically. In FIG. 2, G is a guiding catheter, A is a common carotid artery, I is an internal carotid artery, E is an external carotid artery, C is a deposit composed of cholesterol or thrombus, and p is a part of the deposit C. It is a free substance.

[0007] The vascular site to be dilated, ie, the deposit C
The balloon 7 for PTA is located at the blood vessel (internal carotid artery I) where the is formed, and the balloon 3 for protection is located at a site closer to the peripheral blood vessel than the balloon 7 for PTA. By inflation, blood flow from the internal carotid artery I to peripheral blood vessels in the skull is blocked (see FIG. 2 (1)). In this state, the PTA balloon 7 is inflated. As a result, as shown in FIG. 2 (2), the blood vessels are dilated, and free matter p is generated [see FIG. 2 (2)]. Anyway,
This free matter p is blocked by the inflation protection balloon 3 and does not flow into peripheral blood vessels in the skull. Next, by deflating the PTA balloon 7 and injecting physiological saline from the rear end (not shown) of the guiding catheter G, the loose substance p flows toward the external carotid artery E [see FIG. 2 (3)]. ]. In addition, it is also possible to suction and remove the loose substance p using the guiding catheter G.

[0008] However, when performing PTA, the blood vessels are usually expanded stepwise by PTA balloons having different sizes. Here, as an example of the method of performing PTA, there is a method in which a blood vessel region is pre-dilated with a small-diameter PTA balloon, and then the blood vessel region is expanded to a target inner diameter with a large-diameter PTA balloon. When performing stenting, the stent is placed at a target site with a stent placement balloon (balloon on which the stent is mounted), and then the placed stent is expanded with a stent expansion balloon. The operation of expanding the stent is usually performed stepwise by using stent expansion balloons having different sizes. Further, when performing stenting following PTA, P
After the blood vessel is pre-dilated by the TA balloon, it is necessary to cause the stent to be placed and expanded by the stent placement balloon and the stent expansion balloon.

[0009]

However, in the known balloon catheter device for protection, when the balloon balloon for replacement is replaced, the balloon catheter for protection must be replaced at the same time.

That is, in the protection balloon catheter device 1 having the structure as shown in FIG. 1, the injection port 4 constituting the balloon catheter obstructs the PT.
Only the balloon catheter device 5 for A cannot be removed. Also, if the injection port 4 is removed from the catheter 2 in order to remove the balloon catheter device 5 for PTA, the protection balloon 3 will deflate and block the blood flow from the internal carotid artery to peripheral blood vessels. become unable.

When the protection balloon catheter is removed together with the dilatation balloon catheter, the blood staying in front of the protection balloon is physiologically absorbed so that the cholesterol mass released during the dilatation of the blood vessel does not flow into the peripheral blood vessels. It is necessary to flush the external carotid artery with saline solution. As described above, every time the balloon catheter for replacement is exchanged, it is extremely complicated to wash out the staying blood, which leads to a longer operation time.

Further, if the protection balloon catheter is removed together with the dilatation balloon catheter, a dilatation balloon catheter having a balloon of a new size must be inserted using a guide wire or the like. The operation of inserting a dilatation balloon catheter while selecting a stenotic blood vessel is extremely complicated.

The present invention has been made based on the above circumstances. An object of the present invention is to provide a balloon catheter device that can replace (remove and insert) a parent catheter while the balloon is inflated. Another object of the present invention is to provide a balloon catheter device for distal protection that can replace (remove and insert) a dilatation balloon catheter in a state where the balloon is inflated on the peripheral side of a vascular site to be dilated. Is to provide. Yet another object of the present invention is to provide a balloon catheter system in which such a balloon catheter device is inserted into the lumen of a dilatation balloon catheter.

[0014]

A balloon catheter device according to the present invention comprises a catheter (10) and a balloon (2) mounted on a distal end (11) of the catheter (10).
0) and a chuck mechanism for holding a rear end (12) of the catheter (10), and the chuck mechanism allows the injection to be detachably mounted on the rear end (12) of the catheter (10). It has a port (30) and a tip (41) inserted into the lumen of the catheter (10) so as to airtightly or liquid-tightly close the rear end opening (12A) of the catheter (10). Tip (41)
Is inserted into the lumen, whereby the shaft (4) connected to the rear end (12) of the catheter (10) is
0).

Further, a valve (35) for maintaining the pressure in the lumen of the catheter (10) is provided at the injection port (30), and the valve (35) is provided at the rear end of the catheter (10). Preferably, the structure is such that it can be closed when the shaft (40) is removed from (12).

Further, an extension shaft may be connected to a rear end of the shaft (40).

The balloon catheter apparatus of the present invention comprises a catheter (10), a balloon (50) mounted on the distal end (11) of the catheter (10), and having an opening (52A) at the distal end, and the catheter (10). ) Having a chuck mechanism for holding the rear end (12) of the catheter (10).
An injection port (60) removably attached to 2), and a shaft (70) inserted from the injection port (60) and penetrating through the lumen of the catheter (10) and the inside of the balloon (50). A tip (71) projecting from the opening (52A) so as to airtightly or liquid-tightly close the opening (52A) of the balloon (50);
This tip (71) is connected to the opening (5) of the balloon (50).
When closing the 2A), the catheter (10) has an enlarged diameter portion (72) capable of closing the rear end opening (12A) of the catheter (10) in an air-tight or liquid-tight manner.

An extension shaft may be connected to a rear end of the shaft (70).

The balloon catheter apparatus of the present invention comprises a catheter (80), a balloon (20) mounted on the distal end (81) of the catheter (80), and a rear end opening (82A) of the catheter (80). The tip (91) is inserted into the lumen from the front, and the tip (91) is inserted into the lumen to thereby be injected into the rear end (82) of the catheter (80). A port (90), and the catheter (80) is provided with a valve (83) for maintaining the internal pressure of the balloon (20), and the valve (83) is connected to the injection port ( 90) is opened when mounted, and closed when the injection port (90) is removed.

The catheter (10) and the balloon (2)
0), injection port (30) and shaft (4)
0) according to the present invention (the balloon catheter device according to claim 1 or 2), wherein the length of the catheter (10) is L.
And _10, a length of the shaft (40) when the L _40, preferably satisfies the condition _{0.3 ≦ (L 40 / L 10} ).

The catheter (10) and the balloon (2)
0), injection port (30) and shaft (4)
0) and an extension shaft, the balloon catheter device according to the present invention (the balloon catheter device according to claim 3), wherein the length of the catheter (10) is L _10.
When the length of the connection between the shaft (40) and the extension shaft is L40 _{+ E} , 0.3 ≦ (L
_{40 + E} / L ₁₀ ).

The catheter (10) and the balloon (5)
0), the injection port (60) and the shaft (7).
0) The balloon catheter device of the present invention comprising:
(The balloon catheter device according to claim 4)
Sets the length of the catheter (10) to L_TenAnd the
The length of the shaft (70) is L₇₀Where 1.3 ≦ (L
₇₀/ L_TenIt is preferable to satisfy the condition of (1).

The catheter (10) and the balloon (5)
0), the injection port (60) and the shaft (7).
0) and an extension shaft, the balloon catheter device according to the present invention (the balloon catheter device according to claim 5), wherein the length of the catheter (10) is L _10.
When the length of the connection between the shaft (70) and the extension shaft is L _{70 + E} , 1.3 ≦ (L
_{70 + E} / L ₁₀ ).

The balloon catheter system of the present invention comprises:
The balloon catheter device of the present invention is characterized in that it is inserted into the lumen of a balloon catheter for expansion.

The balloon catheter system of the present invention comprises:
The balloon catheter device of the present invention (the balloon catheter device according to claim 1 or 2) comprising a catheter (10), a balloon (20), an injection port (30), and a shaft (40) is an expansion balloon. When the length when the catheter (10) and the shaft (40) are connected to each other is L10 _{+ 40} and the total length of the dilatation balloon catheter is Le, 1 0.5 ≦ (L _{10 + 40} / Le).

The balloon catheter system of the present invention comprises:
The balloon catheter device of the present invention comprising the catheter (10), the balloon (20), the injection port (30), the shaft (40), and the extension shaft (the balloon catheter device according to claim 3) is an expansion balloon catheter. The length when the catheter (10), the shaft (40) and the extension shaft are connected is L10 _{+ 40 + E,} and the total length of the dilatation balloon catheter is Le. Where 1.5 ≦ (L
_{10 + 40 + E} / Le).

[0027] The balloon catheter system of the present invention comprises:
Catheter (10), balloon (50) and injector
And a shaft port (60) and a shaft (70).
The balloon catheter device of the present invention (the bag
Rune catheter device)
The shaft (70) is inserted through the lumen.
L₇₀And the total length of the dilatation balloon catheter is Le.
When 1.5 ≦ (L ₇₀/ Le)
It is characterized by.

The balloon catheter system of the present invention comprises:
The balloon catheter device (balloon catheter device according to claim 5) of the present invention comprising a catheter (10), a balloon (50), an injection port (60), a shaft (70), and an extension shaft is a balloon catheter for expansion. The length when the shaft (70) and the extension shaft are connected to each other is L _{70 + E,} and the total length of the dilatation balloon catheter is Le.
Where the condition 1.5 ≦ (L _{70 + E} / Le) is satisfied.

The balloon catheter system of the present invention comprises:
The balloon catheter device according to the present invention (the balloon catheter device according to any one of claims 1 to 5) is inserted into the lumen of a dilatation balloon catheter to form a catheter (10) constituting the balloon catheter device. the length and L _10, when the Le a total length of the dilatation balloon catheter, characterized by satisfying the condition of _{1.5 ≧ (L 10 / Le)} .

[0030]

[Action] [1] Opening the rear end of the catheter (10) (12)
Since A) is air-tightly or liquid-tightly closed by the tip portion (41) of the shaft (40), even if the injection port (30) is removed from the rear end portion (12) of the catheter (10), the catheter ( The pressure in the lumen of 10) and inside the balloon (20) is maintained. Therefore, the injection port (30) can be removed from the rear end (12) of the catheter (10) while the balloon (20) is inflated. Then, by removing the injection port (30) from the rear end (12) of the catheter (10), the dilatation balloon catheter can be withdrawn along the catheter (10) and the shaft (40). A dilatation balloon catheter with a new size balloon can be easily inserted along the shaft (40) and the catheter (10).

[2] Since the injection port (30) is provided with a valve (35) for maintaining the pressure in the lumen of the catheter (10), the rear end portion (12) of the catheter (10) is provided. The balloon (20) does not deflate even when the shaft (40) is removed from the shaft. Also, a fluid injection adapter is attached to the injection port (30), and a fluid (gas or liquid) is injected into the lumen of the catheter (10) from the adapter to inflate the balloon (20). When the adapter is removed, the balloon (20) does not deflate.

[3] Opening (52A) of balloon (50)
Is air-tightly or liquid-tightly closed by the distal end portion (71) of the shaft (70), and the rear end opening (12A) of the catheter (10) is air-tight or liquid-tight by the enlarged diameter portion (72) of the shaft (70). Is closed. Thereby, even if the injection port (60) is removed from the rear end (12) of the catheter (10), the pressure inside the lumen of the catheter (10) and the inside of the balloon (50) is maintained.
Therefore, with the balloon (50) inflated,
The injection port (60) can be removed from the rear end (12) of the catheter (10). And
The injection port (60), which has been an obstacle when removing the dilatation balloon catheter, is inserted into the catheter (1).
0) can be removed from the rear end (12) so that the dilatation balloon catheter can be withdrawn along the catheter (10) and the shaft (70), and the dilatation balloon with the new size balloon can be removed. A balloon catheter can be easily inserted along the shaft (70) and the catheter (10).

[4] Since the catheter (80) is provided with a valve (83) for maintaining the internal pressure of the balloon (20), the catheter (80) is inflated with the balloon (20) inflated. 80) rear end (8
The injection port (90) can be removed from 2). And the injection port (90)
Is removed, and the rear end opening (82) of the catheter (80) is removed.
By inserting the shaft from A) into the lumen, the dilatation balloon catheter can be withdrawn along the catheter (80) and the shaft, and the dilatation balloon catheter with the new size balloon can be inserted into the shaft and It can be easily inserted along the catheter (80).

[5] Catheter (10) and shaft (4)
0) is 1.5 times or more the total length (Le) of the dilatation balloon catheter, and the length (L) of the shaft (70) is larger than the length (L _{10 +40} ). ₇₀ )
Is 1.5 times the total length (Le) of the dilatation balloon catheter.
By being twice or more, it is possible to remove only the dilatation balloon catheter in a state where the protection balloon is securely placed at a predetermined site.

[0035]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described below in detail with reference to the drawings. <First Embodiment> FIG. 3 is an explanatory sectional view showing one embodiment of a balloon catheter device (protection balloon catheter device) of the present invention. The balloon catheter device for protection includes a catheter 10, a protection balloon 20, an injection port 30,
And a shaft 40.

The catheter 10 includes an elastomer pipe,
It is composed of a metal pipe, a composite pipe in which a metal wire is braided on the inner wall of an elastomer, and the like. Examples of the metal material forming the catheter 10 include stainless steel and a superelastic alloy. Inner diameter of catheter 10 (inner diameter when tip 41 of shaft 40 is not inserted)
Is, for example, 0.3 to 0.5 mm, and the outer diameter is, for example, 0.7 to 1.0 mm. The length of the catheter 10 is preferably 1.5 times or less the entire length of the dilatation balloon catheter that is the parent catheter with respect to the catheter 10, and is, for example, 1500 to 2000 mm. When the length of the catheter 10 is 1.5 times or less the total length of the balloon balloon for expansion, the inflation operation and the deflation operation of the protection balloon 20 can be performed more easily. It is preferable that the outer surface of the catheter 10 is coated with a hydrophilic resin, whereby the frictional resistance with the inner surface of the dilatation catheter is reduced, and the removal and insertion operations of the dilatation catheter can be performed smoothly. Can be. In order not to damage the inner wall of the blood vessel, the distal end 11 of the catheter 10 is
It is preferable to have flexibility as compared with other parts. A contrast tip (not shown) made of platinum or the like is provided at the distal end 11 of the catheter 10.

The protection balloon 20 is mounted on the distal end portion 11 of the catheter 10, and the inside of the protection balloon 20 communicates with the lumen of the catheter 10. Examples of a constituent material of the protection balloon 20 include silicone rubber. The outer diameter of the protection balloon 20 at the time of inflation is, for example, 3 to 15 mm. An imaging chip 20C made of platinum or the like is provided at the tip of the protection balloon 20.

The injection port 30 is detachably mounted on the rear end 12 of the catheter 10 and
0 rear end opening 12A
0 lumen. The distal end 41 of the shaft 40 is inserted into the lumen of the catheter 10 so as to airtightly or liquid-tightly close the rear end opening 12A.

As shown in FIG. 4, the injection port 30 has a tip 31, a port body 32 screwed to the tip 31 and acting as a rotator, and a tip 3.
Rubber sleeve 33 interposed between port 1 and port body 32
And a valve 35 formed of an O-ring provided in the lumen (conduit) of the port body 32. The injection port 30 includes a chuck mechanism that holds the outer periphery of the rear end portion 12 of the catheter 10. The chuck mechanism includes a distal end portion 31, a port body 32, and a rubber sleeve 33. That is, in a state where the rear end portion 12 of the catheter 10 is inserted into the lumen of the injection port 30, while pressing the front end portion 31,
When the port main body 32 is turned in a direction in which the first surface 31A and the surface 32A of the port main body 32 approach each other, the rear end portion 12 of the catheter 10 is tightened by the rubber sleeve 33 compressed in the axial direction. Thereby, the injection port 30 is mounted on the rear end portion 12 of the catheter 10. When the port main body 32 is turned in a direction in which the surface 31A and the surface 32A are separated from each other, the catheter 10 by the rubber sleeve 33 is rotated.
The tightening force on the rear end 12 is released. Thereby, the rear end 12 of the catheter 10 is connected to the injection port 3.
0 from the lumen of catheter 0, ie, catheter 10
The injection port 30 can be detached from the rear end portion 12.

The valve 35 provided in the injection port 30 is opened when the distal end portion 41 of the shaft 40 is inserted into the lumen of the catheter 10 (see FIG. 4). 40
When it is removed, it is closed (see FIG. 5). By providing the valve 35 having such a structure, even if the shaft 40 is removed from the rear end portion 12 of the catheter 10 in a state where the protection balloon 20 is inflated, the lumen of the catheter 10 and the protection The pressure inside the balloon 20 is maintained, and the protection balloon 20 does not deflate. In addition, after a fluid injection adapter is attached to the injection port 30 and a fluid is injected into the lumen of the catheter 10 via the adapter to inflate the protection balloon 20, the protection is removed even if the adapter is removed. The balloon 20 does not deflate.

The valve provided at the injection port is not limited to a valve comprising an O-ring, but may include various valves including those described below.

FIGS. 6A and 6B are cross-sectional views showing an injection port provided with a duckbill valve 35D as a valve for maintaining the pressure in the lumen of the catheter. As shown in FIG.
When the distal end portion 41 of the shaft 40 is inserted into the lumen of the catheter 10, the duckbill valve 35D is in an open state, and the distal end portion 4 of the shaft 40 extends from the lumen of the catheter 10.
When 1 is removed and the shaft 40 is removed from the injection port 30, the duckbill valve 35D is closed as shown in FIG. 6 (2).

FIGS. 7 (1) and 7 (2) are sectional views showing an injection port provided with a rubber sleeve as a valve for maintaining the pressure in the lumen of the catheter.
The injection port 36 shown in FIG.
A port body 38 screwed to the tip portion 37; a rotator 39 screwed to the port body 38; and a rubber sleeve 35 interposed between the tip portion 37 and the port body 38.
1 and a rubber sleeve 352 (a valve for maintaining the pressure in the lumen of the catheter) interposed between the port body 38 and the rotator 39.

As shown in FIG. 7A, the catheter 10
When the distal end portion 41 of the shaft 40 is inserted into the internal cavity of the shaft 40, the valve formed of the rubber sleeve 352 is in an open state. Then, the shaft 40 is removed from the injection port 36 and the rotator 39 screwed to the port body 38 is turned to rotate the rubber sleeve 35.
By compressing 2 in the axial direction, the valve made of the rubber sleeve 352 can be closed as shown in FIG. 7 (2).

FIG. 8 is a cross-sectional view showing an injection port provided with a slit valve 35S as a valve for maintaining the pressure in the lumen of the catheter. As shown in FIG. When the shaft is removed, the slit valve 35S is closed.

As shown in FIGS. 3 and 4, the rear end opening 12A of the catheter 10 is provided in the lumen of the catheter 10.
The tip 41 of the shaft 40 is inserted so as to seal airtight or liquidtight. Thereby, the catheter 10 and the shaft 40 are connected, and the catheter 10
Of the catheter 10 and the pressure inside the protection balloon 20 can be maintained, and the rear end portion 12 of the catheter 10 can be maintained while the protection balloon 20 is inflated.
The injection port 30 can be removed from the device.

The injection port 30 which has been an obstacle when removing the dilatation balloon catheter is removed.
Is removed from the rear end portion 12 of the catheter 10, whereby the dilatation balloon catheter is connected to the catheter 10.
And can be withdrawn along the shaft 40, and a dilatation balloon catheter with a new size balloon can be easily inserted along the shaft 40 and the catheter 10.

As a constituent material of the shaft 40, stainless steel and a titanium nickel alloy can be exemplified. As shown in FIG. 4, the distal end portion 41 of the shaft 40 has a corrugated cross-sectional shape, whereby air-tightness or liquid-tightness in the lumen of the catheter 10 can be reliably maintained. The diameter of the distal end portion 41 inserted into the lumen of the catheter 10 is d (m) when the inner diameter of the catheter 10 (the inner diameter when the distal end portion 41 is not inserted) is d (m
m), the minimum diameter is, for example, (d-0.10)
[Mm] or more and (d−0.05) [mm] or less, and the maximum diameter is, for example, d [mm] or more and (d + 0.10) [m
m]. The diameter of the shaft 40 in a portion other than the distal end portion 41 is the injection port 30
The size is not particularly limited as long as it can be inserted into the lumen of the catheter 10, but is preferably equal to or less than the outer diameter of the catheter 10. The sectional shape of the distal end of the shaft 40 is not particularly limited, and may have a tapered cross section like the distal end 411 shown in FIG. 9 or the distal end 412 shown in FIG. As shown in the figure, it may have the same cross-sectional shape as other parts.

The length of the shaft 40 is, for example, 500 to 2
000 mm. When the total length of the balloon catheter for expansion is Le, and the length when the catheter 10 and the shaft 40 are connected is L _{10 + 40} , (L _{10 + 40} /
It is preferable to adjust the length of the shaft 40 so that the value of Le) is 1.5 or more, particularly 2 or more. (L
_When the value of ( _{10 + 40} / Le) is 1.5 or more, only the dilatation balloon catheter can be removed while the protection balloon 20 is securely placed at a predetermined site. When the value of (L _{10 + 40} / Le) is less than 1.5, when only the dilatation balloon catheter is withdrawn while the protection balloon is indwelled, the dilatation balloon catheter is withdrawn. In the middle of the operation, the rear end (hand end) of the dilatation balloon reaches the rear end (hand end) of the shaft, and when the dilatation balloon catheter is to be further removed therefrom, it is left at a predetermined position. There is a risk that the protection balloon that has been removed may move in the direction in which it is being removed (hand side).

[0050] In addition, the length of the catheter 10 and L _10,
When the length of the shaft 40 and _{L 40, (L 40 / L} 10)
Is preferably 0.3 or more, more preferably 0.5 to 1.5. The value of (L ₄₀ / L ₁₀ ) is 0.
By being 3 or more, the value of (L10 _{+ 40} / Le) can be made 1.5 or more.

FIGS. 11 and 12 are cross-sectional views for illustrating a modification of the balloon catheter device according to the embodiment of the present invention. The injection port 3 shown in FIG.
0 and the shaft 40 have the same configuration as that shown in FIG. The protection balloon catheter device shown in FIG. 11 is provided with a protection balloon 25 so as to surround the outer peripheral surface of the distal end portion of the catheter 15. That is, the protection balloon 25 has one end and the other end adhered to the outer peripheral surface of the distal end portion of the catheter 15, and a single lumen of the catheter 15 is provided with a through-hole 16 formed in the peripheral wall of the catheter 15. Is connected to the internal space of the protection balloon 25 via the.
An end sleeve 17 is connected to a distal end of the catheter 15, and an opening 19 for inserting a guide wire 18 is formed in a peripheral wall of the end sleeve 17.

The protection balloon catheter apparatus shown in FIG. 12 is provided with a protection balloon 25 so as to surround the outer peripheral surface of the distal end portion of the catheter 13, and the lumen 13A of the catheter 13 It communicates with the internal space of the protection balloon 25 via a through hole 14A formed in the peripheral wall. A guide wire 1 is provided on the peripheral wall of the catheter 13.
An opening 14 </ b> B for inserting the first opening 8 is formed.
The guide wire 18 inserted from 4B passes through the lumen 13B of the catheter 13 and protrudes from the distal end opening of the catheter 13.

Hereinafter, a procedure for performing PTA, including an operation of exchanging the balloon catheter for PTA, which is performed using the balloon catheter device for protection having the configuration shown in FIG. 3 will be described.

(1) A balloon catheter for PTA (I) is inserted into the lumen of a guiding catheter which has been inserted in advance so as to be opened in front of a vascular site (internal carotid artery) to be dilated.
Is inserted, and the small-diameter PTA balloon (i) attached to the tip is positioned at the vascular site to be expanded.

(2) PTA balloon catheter (I)
The protection balloon catheter device having the configuration shown in FIG. 3 is inserted into the lumen, and the protection balloon 20 is positioned at a position closer to the peripheral blood vessel than the PTA balloon (i). At this stage, the shaft 40 may not be connected to the rear end 12 of the catheter 10.

(3) In a state where the shaft 40 is not connected to the rear end portion 12 of the catheter 10, as shown in FIG. The distal end portion 34A of the catheter 34 is inserted into the lumen of the catheter 10. Next, a fluid is injected into the lumen of the catheter 10 from a syringe (not shown) via the adapter 34, and the protection balloon 20 is inflated to cut off the blood flow from the internal carotid artery to the peripheral blood vessels.

(4) Remove the adapter 34 from the injection port 30. At this time, the valve 35 composed of the O-ring is closed (the state as shown in FIG. 5), the pressure inside the lumen of the catheter 10 and the inside of the protection balloon 20 is maintained, and the protection balloon 20 is inflated. (A state in which blood flow to peripheral blood vessels is blocked) can be maintained.

(5) The shaft 40 is inserted through the opening of the injection port 30, and the tip 41 is inserted into the lumen of the catheter 10. Thereby, the catheter 10
And the shaft 40 are connected, and the catheter 1
0 is in a state where the rear end opening 12A is air-tightly or liquid-tightly closed.

(6) By turning the port main body 32 in a direction in which the surface 31A of the distal end portion 31 of the injection port 30 and the surface 32A of the port main body 32 are separated from each other (direction of releasing the compressive force on the rubber sleeve 33), The injection port 30 is removed from the rear end 12 of the catheter 10 by relaxing the tightening force of the rubber sleeve 33 on the rear end 12 of the catheter 10 (see FIG. 14). At this time, the protection balloon 20 can keep the inflated state.

(7) The vascular site is pre-dilated by inflating the PTA balloon (i) according to a usual method. Next, the PTA balloon (i) is deflated. At this time, the lump of cholesterol released at the time of inflation of the PTA balloon (i) is blocked by the inflated protection balloon 20 and does not flow into peripheral blood vessels.

(8) While holding down the rear end (hand end) of the shaft 40 so that the protection balloon 20 does not move, only the balloon catheter (I) for PTA is withdrawn along the catheter 10 and the shaft 40.

(9) PTA balloon catheter (II)
Is inserted along the shaft 40 and the catheter 10,
The large-diameter PTA balloon (ii) attached to the distal end is positioned at the vascular site to be expanded (pre-expanded site). Next, the vascular site is expanded to a target inner diameter by inflation of a balloon (ii) for PTA according to a usual method, and then the PTA is inflated.
The balloon (ii) is deflated.

(10) Blood Retaining in Front of Protective Balloon 20 (Blood Containing Cholesterol Mass)
After flushing to the external carotid artery side, the shaft 40 is removed from the lumen of the catheter 10 and the protection balloon 20 is removed.
Deflate. Next, the balloon catheter for protection is removed together with the balloon catheter for PTA (II).

<Second Embodiment> FIG. 15 is an explanatory sectional view showing another embodiment of the balloon catheter device (protection balloon catheter device) of the present invention. This balloon catheter device for protection includes a catheter 10, a protection balloon 50, an injection port 60 with a side arm, and a shaft 70 that penetrates the lumen of the catheter 10 and the inside of the protection balloon 50.

The catheter 10 is the same as the catheter constituting the protection balloon catheter device (first embodiment) shown in FIG.

The protection balloon 50 is mounted on the distal end portion 11 of the catheter 10, and the inside of the protection balloon 50 communicates with the lumen of the catheter 10. The protection balloon 50 includes a balloon body 51.
And a cylindrical portion 52 having an opening 52A at the tip.
The cylindrical portion 52 is provided with a contrast chip 50C made of platinum or the like. Examples of the constituent material of the balloon body 51 include silicone rubber and the like, and examples of the constituent material of the tubular portion 52 include platinum, silver, gold, and tungsten. Protective balloon 50
The outer diameter at the time of inflation is, for example, 3 to 15 mm
It is said.

The injection port 60 is detachably attached to the rear end portion 12 of the catheter 10, and the rear end opening 12 A of the catheter 10 is connected to the injection port 60.
Is located in the lumen.

The shaft 70 is inserted through the opening 60 A of the injection port 60 and is mounted so as to penetrate the lumen of the catheter 10 and the inside of the protection balloon 50. The shaft 70 has a distal end portion 71 protruding from the opening 52A so as to airtightly or liquid-tightly close the opening 52A of the protection balloon 50, and when the distal end portion 71 covers the opening 52A of the protection balloon 50. And a diameter-enlarging portion 72 capable of closing the rear end opening 12A of the catheter 10 in an airtight or liquid tight manner. Here, the “increased diameter portion 72” refers to the inner diameter of the catheter 10 (the inner diameter when the enlarged diameter portion is not inserted) (d)
, The tapered portion (where α ≧ 0, β ≧ 0) whose diameter increases from (d−α) to (d + β). A contrast coil (70C) made of platinum or the like is welded to the distal end portion 71 of the shaft 70.

FIG. 16 is a partially enlarged view of the balloon catheter device for protection shown in FIG. 15, and FIG.
Is a state in which the rear end opening 12A of the catheter 10 is not closed by the enlarged diameter portion 72 of the shaft 70 (catheter 1).
0 is in a state in which fluid can be injected into the lumen of FIG.
(2) shows a state in which the rear end opening 12A of the catheter 10 is closed by the enlarged diameter portion 72 of the shaft 70 (a state in which the pressure in the lumen of the catheter 10 is maintained).

As shown in FIG. 16, the injection port 60 has a front end 61, a port main body 62 with a side arm screwed to the front end 61, and a rear end 63 screwed to the port main body 62. , A rubber sleeve 64 interposed between the distal end portion 61 and the port body 62,
2 and a rubber sleeve 65 interposed between the rear end portion 63.

The injection port 60 has a chuck mechanism for holding the outer periphery of the rear end portion 12 of the catheter 10. The chuck mechanism includes a distal end portion 61, a port body 62, and a rubber sleeve 64. .
That is, with the rear end 12 of the catheter 10 inserted into the lumen of the injection port 60, while pressing the front end 61, the surface 61 A of the front end 61 and the port body 62 are pressed.
When the port body 62 is turned in a direction in which the surface 62A approaches, the rear end portion 12 of the catheter 10 is tightened by the rubber sleeve 64 compressed in the axial direction. Thereby, the injection port 60 is mounted on the rear end portion 12 of the catheter 10. When the port body 62 is turned in a direction in which the surface 61A and the surface 62A are separated from each other, the tightening force of the rubber sleeve 64 on the rear end portion 12 of the catheter 10 is released. Thereby, withdrawing the rear end portion 12 of the catheter 10 from the lumen of the injection port 60,
That is, the injection port 60 can be removed from the rear end 12 of the catheter 10.

Further, the injection port 60
A chuck mechanism is provided for holding the outer periphery of the shaft 70 inserted into the lumen. The chuck mechanism includes a port body 62, a rear end 63, and a rubber sleeve 65. That is, the injection port 60
With the shaft 70 inserted through the lumen of the port body 6
When the rear end 63 is turned in a direction in which the surface 62B of the port body 62 and the surface 63B of the rear end 63 approach each other while holding down 2, the outer periphery of the shaft 70 is tightened by the rubber sleeve 65 compressed in the axial direction. .

The diameter of the distal end portion 71 of the shaft 70 is such that the opening 52 A of the protection balloon 50 can be air-tightly or liquid-tightly closed, and can be inserted into the lumen of the catheter 10. It needs to be large. Note that the tip portion 71 may be formed in a tapered shape so that the diameter thereof increases continuously. In addition, the minimum diameter of the enlarged diameter portion 72 of the shaft 70 (d−
α) is (d−0.20) [mm] or more and (d−0.0
5) [mm] or less, and the maximum diameter (d + β) is d [m
m] or more and (d + 0.10) [mm] or less. In addition, the shaft 7 between the tip portion 71 and the enlarged diameter portion 72
The diameter of 0 is not particularly limited as long as it can be inserted into the lumen of the catheter 10. The diameter of the shaft 70 on the rear end side (hand side) of the enlarged diameter portion 72 is not particularly limited as long as it can be inserted into the lumen of the injection port 60.

The length (L ₇₀ ) of the shaft 70 is preferably 1.5 times or more, and more preferably 2 times or more, the total length (Le) of the dilatation balloon catheter serving as a parent catheter with respect to the catheter 10. It is said. (L ₇₀ / L
When e) is 1.5 or more, only the dilatation balloon catheter can be withdrawn while the protection balloon 50 is securely placed at a predetermined site. The shaft 7 with respect to the length (L ₁₀ ) of the catheter 10
Preferably the value is 1.3 or more of the ratio of the length of _{0 (L 70) (L 70} / L 10), more preferably 1.5 to 2.2
It is said. By the value of (L ₇₀ / L ₁₀₎ is 1.3 or more, it is possible to a value of 1.5 or more (L ₇₀ / Le). The specific length of the shaft 70 is, for example, 1000 to 4000 mm.

An extension shaft may be connected to the rear end of the shaft. The connecting means between the shaft and the extension shaft is not particularly limited. For example, as shown in FIG. 17A, the tip 74 of the extension shaft 73 is formed in a pipe shape, and the inside of the tip 74 is formed. Means for connecting by inserting a rear end portion 75 of a tapered shaft 70, as shown in FIG. 17 (2), a rear end portion 76 of a tapered shaft 70.
And the connecting pipe 7 with the tip 78 of the extension shaft 77.
And means for connecting by inserting it into the reference numeral 9. In addition, when the extension shaft is connected to the rear end of the shaft, the length when both are connected,
It is sufficient that the length is not less than 1.5 times the total length (Le) of the dilatation balloon catheter, and the length when both are connected is not less than 1.3 times the length (L ₁₀ ) of the catheter 10. .

In the protection balloon catheter device of this embodiment, the opening 52A of the protection balloon 50 is air-tightly or liquid-tightly closed by the distal end portion 71 of the shaft 70, and as shown in FIG.
The rear end opening 12A of the catheter 10 is air-tightly or liquid-tightly closed by the enlarged diameter portion 72 of the shaft 70. This allows
The lumen of the catheter 10 and the protection balloon 50
Can be maintained, and the injection port 60 can be removed from the rear end 12 of the catheter 10 while the protection balloon 50 is inflated.

Then, the injection port 60 which has been an obstacle when removing the dilatation balloon catheter is removed.
Is removed from the rear end portion 12 of the catheter 10 so that the balloon catheter for expansion is connected to the catheter 1.
0 and can be withdrawn along the shaft 70, and a dilatation balloon catheter with a new size balloon can be easily inserted along the shaft 70 and the catheter 10.

Hereinafter, a procedure for performing PTA including an operation of replacing a balloon catheter for PTA, which is performed using the balloon catheter device for protection having the configuration shown in FIG. 15, will be described.

(1) A balloon catheter for PTA (I) is inserted into the lumen of a guiding catheter which is inserted in advance so as to be opened in front of a vascular site (internal carotid artery) to be dilated.
Is inserted, and the small-diameter PTA balloon (i) attached to the tip is positioned at the vascular site to be expanded.

(2) PTA balloon catheter (I)
The protection balloon catheter device having the configuration shown in FIG. 15 is inserted into the lumen, and the protection balloon 50 is positioned at a site closer to the peripheral blood vessel than the PTA balloon (i). At this time, the rear end opening 12A of the catheter 10 constituting the protection balloon catheter device is in a state not closed by the enlarged diameter portion 72 of the shaft 70 (a state shown in FIG. 16A). The outer circumference of the shaft 70 is fastened by the rubber sleeve 65. The shaft 70 functions as a guide wire when the protection balloon catheter device is inserted.

(3) A fluid is injected into the lumen of the catheter 10 from the side arm of the injection port 60 to inflate the protection balloon 50, and the rubber sleeve 65 is pressed while holding the port body 62.
By turning the rear end 63 in the direction of releasing the compressive force to the outside, the tightening force of the rubber sleeve 65 on the outer periphery of the shaft 70 is reduced, and the rear end opening 12A of the catheter 10
2 so that the shaft 70 is sealed air-tight or liquid-tight.
Is advanced (the state shown in FIG. 16 (2)). And
When the rear end opening 12A of the catheter 10 is air-tightly or liquid-tightly closed by the enlarged diameter portion 72, the opening 52A of the protection balloon 50 is also air-tightly or liquid-tightly closed by the distal end portion 71 of the shaft 70. As a result, the pressure in the lumen of the catheter 10 and the inside of the protection balloon 50 is maintained, and the inflated protection balloon 50 blocks blood flow from the internal carotid artery to the peripheral blood vessels.

(4) While holding down the distal end 61 of the injection port 60, the port is moved in the direction in which the surface 61A of the distal end 61 and the surface 62A of the port body 62 are separated (in the direction in which the compressive force to the rubber sleeve 64 is released). Body 62
Is rotated to adjust the rear end 12 of the rubber sleeve 64.
The injection port 60 is removed from the rear end portion 12 of the catheter 10 with the tightening force applied to the catheter 10 reduced. At this time,
The protection balloon 50 can keep the inflated state.

(5) The vascular site is pre-dilated by inflating the PTA balloon (i) according to a usual method. Next, the PTA balloon (i) is deflated. At this time, the cholesterol mass released at the time of inflation of the PTA balloon (i) is blocked by the inflated protection balloon 50 and does not flow into peripheral blood vessels.

(6) While holding down the rearmost end (hand end) of the shaft 70 so that the protection balloon 50 does not move, only the PTA balloon catheter (I) is withdrawn along the catheter 10 and the shaft 70.

(7) Balloon catheter for PTA (II)
Is inserted along the shaft 70 and the catheter 10,
The large-diameter PTA balloon (ii) attached to the distal end is positioned at the vascular site to be expanded (pre-expanded site). Next, the vascular site is expanded to a target inner diameter by inflation of the PTA balloon (ii) according to an ordinary method, and then the PTA balloon (ii) is deflated.

(8) Blood Retaining in Front of Protective Balloon 50 (Blood Containing Cholesterol Mass)
After flushing to the external carotid artery, a protection balloon 5
0 and the lumen of the catheter 10
Is removed to deflate the protection balloon 50. Next, the balloon catheter for protection is removed together with the balloon catheter for PTA (II).

<Third Embodiment> FIG. 18 is an explanatory sectional view showing another embodiment of the balloon catheter device (protection balloon catheter device) of the present invention. This protection balloon catheter device includes a catheter 80, a protection balloon 20 attached to a distal end portion 81 of the catheter 80, and a rear end opening 8 of the catheter 80.
An insertion port 90 attached to the rear end 82 of the catheter 80 by inserting the distal end 91 into the lumen from 2A is provided. This embodiment is characterized in that a valve 83 for maintaining the internal pressure of the protection balloon 20 is provided in the catheter 80. As shown in FIG. 19A, when the injection port 90 is attached to the rear end 82 of the catheter 80, that is, when the distal end 91 is inserted into the lumen of the catheter 80, the valve 83 is opened. When the injection port 90 is removed from the rear end portion 82 of the catheter 80, the valve 83 is closed as shown in FIG. 19 (2).

Since the catheter 83 is provided with the valve 83, the injection port 90 can be removed from the rear end 82 of the catheter 80 while the protection balloon 20 is inflated. Then, after removing the injection port 90, as shown in FIG. 19 (3), by inserting the distal end portion 46 of the shaft 45 into the lumen of the catheter 80, the protection balloon 20 is inflated, The dilatation balloon catheter can be withdrawn along the catheter 80 and the shaft 45, and a dilatation balloon catheter with a new size balloon can be easily inserted along the shaft 45 and the catheter 80.

The procedure for performing PTA, including the operation of exchanging the balloon catheter for PTA, performed using the balloon catheter device for protection having the configuration shown in FIG. 18 will be described below.

(1) The balloon catheter for PTA (I) is inserted into the lumen of the guiding catheter which is inserted in advance so as to be opened in front of the vascular site (internal carotid artery) to be dilated.
Is inserted, and the small-diameter PTA balloon (i) attached to the tip is positioned at the vascular site to be expanded.

(2) Balloon catheter for PTA (I)
The protection balloon catheter device having the configuration shown in FIG. 18 is inserted into the lumen, and the protection balloon 20 is positioned at a position closer to the peripheral blood vessel than the PTA balloon (i).

(3) By injecting a fluid from the injection port 90 into the lumen of the catheter 80 to inflate the protection balloon 20, the blood flow from the internal carotid artery to the peripheral blood vessels is cut off.

(4) Remove the injection port 90 from the lumen of the catheter 80. At this time, the valve 83 provided in the lumen of the catheter 80 is closed, the pressure in the lumen of the catheter 10 and the inside of the protection balloon 20 are maintained, and the protection balloon 20 is in an inflated state ( (A state in which blood flow flowing to peripheral blood vessels is blocked).

(5) By inserting the distal end portion 46 of the shaft 45 into the lumen through the rear end opening 82A of the catheter 80, 1.5 times the total length (Le) of the dilatation balloon catheter is obtained.
Form more than twice as many linked bodies.

(6) The vascular site is pre-dilated by inflating the PTA balloon (i) according to the usual method. Next, the PTA balloon (i) is deflated. At this time, the lump of cholesterol released at the time of inflation of the PTA balloon (i) is blocked by the inflated protection balloon 20 and does not flow into peripheral blood vessels.

(7) While holding down the rear end (hand end) of the shaft 45 so that the protection balloon 20 does not move, only the PTA balloon catheter (I) is withdrawn along the catheter 10 and the shaft 45.

(8) Balloon catheter for PTA (II)
Is inserted along the shaft 45 and the catheter 10,
The large-diameter PTA balloon (ii) attached to the distal end is positioned at the vascular site to be expanded (pre-expanded site). Next, the vascular site is expanded to a target inner diameter by inflation of the PTA balloon (ii) according to an ordinary method, and then the PTA balloon (ii) is deflated.

(9) Blood Retaining on the Front Side of Protective Balloon 20 (Blood Containing Cholesterol Mass)
Is washed out to the external carotid artery side, and the protection balloon 20 is deflated by inserting the injection port 90 into the lumen through the rear end opening 82A of the catheter 80, for example. Next, a balloon catheter for PTA (II)
At the same time, the balloon catheter for protection is removed.

[0099]

<Example 1> Using a balloon catheter device for protection having a configuration as shown in FIG. 3, PTA including a balloon catheter exchange operation and stenting were performed.

[Structure and Specifications of Protective Balloon Catheter Device] The catheter (10) constituting the protect balloon catheter device has an inner diameter of 0.4 m.
m, an outer diameter of 0.8 mm and a length of 1750 mm made of a nylon elastomer pipe having an outer surface coated with a vinylpyrrolidone copolymer (hydrophilic resin). The distal end (11) of the catheter (10) is more flexible than the other parts, and the distal end (11) is provided with a contrast tip made of platinum.

The protection balloon (20) constituting the protection balloon catheter device includes:
A silicone rubber balloon having an outer diameter of about 10 mm when inflated was used. A contrast tip (20C) made of platinum is provided at the tip of the balloon (20).

The shaft (40) constituting the balloon catheter device for protection has a distal end (41) (about 10 mm from the distal end) having a corrugated cross-sectional shape, and has a maximum diameter at the distal end (41). Is 0.42m
m, the minimum diameter is 0.38 mm, the diameter of the shaft (40) other than the tip (41) is 0.8 mm, and the length is 1500 mm.
The stainless steel (SUS304) wire was used.

[PTA and Stenting] A guiding catheter was inserted into the internal carotid artery so as to open before a stenosis site (a vascular site to be dilated). A PTA balloon catheter having a total length of 1500 mm is inserted into the lumen of the guiding catheter, and the PTA balloon (the outer diameter at the time of inflation:
5 mm) at the site of the stenosis. Then, PTA
A balloon catheter device for protection (a catheter device with the shaft 40 removed) was inserted into the lumen of the balloon catheter for protection, and the protection balloon (20) was positioned at a site closer to the peripheral blood vessel than the balloon for PTA.

In a state where the shaft (40) is not connected to the rear end (12) of the catheter (10), the injection needle-like tip (3) is inserted through the opening of the injection port (30).
The adapter (34) for fluid injection having 4A) was inserted, and the distal end (34A) was inserted into the lumen of the catheter (10). Next, a contrast agent is injected from the syringe into the lumen of the catheter (10) via the adapter (34), and the protection balloon (20) is inflated to cut off the blood flow from the internal carotid artery to the peripheral blood vessels. did.

When the adapter (34) was removed from the injection port (30), the valve (35) of the injection port (30) was closed, and the pressure inside the lumen of the catheter (10) and the inside of the protection balloon (20) was reduced. As a result, the protection balloon (20) was kept in an inflated state.

The shaft (40) was inserted through the opening of the injection port (30), and the tip (41) of the shaft (40) was inserted into the lumen of the catheter (10). Thereby, the catheter (10) and the shaft (4)
0) was connected, and the rear end opening (12A) of the catheter (10) could be closed in a liquid-tight manner.

The face (31A) of the tip (31) of the injection port (30) and the port body (32)
By rotating the port body (32) in a direction in which the surface (32A) of the rubber sleeve (32A) is separated, that is, in a direction of releasing the compressive force on the rubber sleeve (33), the rubber sleeve (3) is rotated.
The tightening force on the rear end (12) by 3) was relaxed, and the injection port (30) was removed from the rear end (12) of the catheter (10).

After injecting a contrast medium from the rear end side (hand side) of the guiding catheter, it was confirmed that the blood flow flowing to the peripheral blood vessels was blocked, and then the contrast medium was injected to remove the PTA balloon. The stenosis was predilated by inflation (injection pressure 10 atm). After a lapse of 30 seconds, the PTA balloon was deflated.

While holding down the rear end (hand end) of the shaft (40) so that the protection balloon (20) would not move, only the PTA balloon catheter was pulled out along the catheter (10) and the shaft (40).

Next, a balloon mounted with a stent (a balloon for indwelling a stent having an outer diameter of 7 mm at the time of inflation) with a total length of 1500 mm attached to the distal end.
Insert a stent placement balloon catheter [I],
The stent placement balloon was positioned at a stenosis site (pre-expanded site) to be expanded. The operation of inserting the stent placement balloon catheter [I] is performed by using a shaft (40).
And it could be performed smoothly along the catheter (10). Next, the stent was expanded by inflating the stent placement balloon, and the outer surface of the stent was pressed against the inner wall of the blood vessel. After 10 seconds,
The stent placement balloon was deflated. The shaft (4) is used to prevent the protection balloon (20) from moving.
While holding the last end (hand end) of (0), only the balloon catheter [I] for indwelling the stent is inserted into the catheter (10).
And withdrawn along the shaft (40).

Next, a stent expansion balloon catheter [II] having a total length of 1500 mm with a stent expansion balloon having an outer diameter of 8 mm at the time of inflation attached to the tip is inserted, and the stent is placed in the stent expansion balloon. Was located at the site. The operation for inserting the stent expansion balloon catheter [II] is performed using a shaft (4).
0) and along the catheter (10). Next, the stent was expanded by inflating a stent expansion balloon, and the outer surface of the stent was pressed against the inner wall of the blood vessel, thereby expanding the blood vessel to a conventional (normal) diameter. After a lapse of 30 seconds, the balloon for stent placement was deflated.

By injecting about 200 ml of physiological saline from the rear end side (hand side) of the guiding catheter, the blood retained on the front side of the protection balloon (20) was flushed to the external carotid artery side. . After removing the shaft (40) from the lumen of the catheter (10) and deflating the protection balloon (20), the balloon balloon for protection was removed together with the balloon catheter for stent expansion [II].

<Embodiment 2> Except for having an injection port (36) as shown in FIG.
Using a balloon catheter device for protection having the same configuration as that shown in (1), PTA and stenting including an operation of replacing the balloon catheter were performed.

[Configuration and Specifications of Protective Balloon Catheter Device] The catheter (10) constituting the protect balloon catheter device has an inner diameter of 0.5 m.
A pipe made of a titanium-nickel alloy having a diameter of 0.8 mm, an outer diameter of 0.8 mm, and a length of 1750 mm was used, the outer surface of which was coated with a Teflon resin (hydrophilic resin). The tip (11) of this catheter (10)
It has more flexibility than other parts,
In 1), an imaging chip made of platinum is provided.

The protection balloon (20) constituting the protection balloon catheter device includes:
A silicone rubber balloon having an outer diameter of about 10 mm when inflated was used. A contrast tip (20C) made of platinum is provided at the tip of the balloon (20).

Further, as for the shaft (40) constituting the balloon catheter device for protection, the distal end (41) (about 10 mm from the distal end) has a corrugated cross-sectional shape, and the maximum diameter at the distal end (41). Is 0.51m
m, the minimum diameter is 0.48 mm, the diameter of the shaft (40) other than the tip (41) is 0.8 mm, and the length is 1500 mm.
Was used.

[PTA and Stenting] A guiding catheter was inserted into the internal carotid artery so as to open before a stenosis site (a vascular site to be dilated). A PTA balloon catheter having a total length of 1500 mm is inserted into the lumen of the guiding catheter, and the PTA balloon (the outer diameter at the time of inflation:
5 mm) at the site of the stenosis. Then, PTA
A protection balloon catheter device (catheter device with the shaft 40 removed) was inserted into the lumen of the balloon balloon for protection, and the protection balloon (20) was positioned at a site closer to the peripheral blood vessel than the PTA balloon. .

In a state where the shaft (40) is not connected to the rear end (12) of the catheter (10), an injection needle-like tip (3) is inserted through the opening of the injection port (36).
The adapter (34) for fluid injection having 4A) was inserted, and the distal end (34A) was inserted into the lumen of the catheter (10). Next, a contrast agent is injected from the syringe into the lumen of the catheter (10) via the adapter (34), and the protection balloon (20) is inflated to cut off the blood flow from the internal carotid artery to the peripheral blood vessels. did.

The adapter was removed from the injection port (36), and the rotator (39) was rotated to compress the rubber sleeve (352) in the axial direction. As a result, the valve made of the rubber sleeve (352) is closed, and the pressure inside the lumen of the catheter (10) and the inside of the protection balloon (20) is maintained.
The protection balloon (20) was kept in an inflated state.

By rotating the rotator (39) to reduce the compressive force on the rubber sleeve (352), the shaft (40) is inserted from the opening of the injection port (36), and the tip (41) of the shaft (40) is inserted. To the catheter (1
0) was inserted into the lumen. Thereby, the catheter (1)
0) and the shaft (40) were connected, and the rear end opening (12A) of the catheter (10) could be closed in a liquid-tight manner.

By rotating the port body (38) in a direction to release the compression force on the rubber sleeve (351) at the injection port (36), the rubber sleeve (351) tightens the rear end (12). The applied force was reduced, and the injection port (36) was removed from the rear end (12) of the catheter (10).

After confirming that the blood flow flowing to the peripheral blood vessels was blocked by injecting the contrast agent from the rear end side (hand side) of the guiding catheter, the contrast agent 50 was injected.
And a mixture of 50% by volume of physiological saline and 50% by volume of physiological saline.
Inflate the TA balloon (injection pressure 10 at
m), the stenosis site was predilated. After 15 seconds, PT
The balloon for A was deflated.

While pressing the rear end (hand end) of the shaft (40) so that the protection balloon (20) would not move, only the PTA balloon catheter was pulled out along the catheter (10) and the shaft (40).

Next, a balloon having a stent mounted thereon (a balloon for indwelling a stent having an outer diameter of 7 mm at the time of inflation) is attached at the tip to a total length of 1350 mm.
Insert a stent placement balloon catheter [I],
The stent placement balloon was positioned at a stenosis site (pre-expanded site) to be expanded. The operation of inserting the stent placement balloon catheter [I] is performed by using a shaft (40).
And it could be performed smoothly along the catheter (10). Next, the stent was expanded by inflating the stent placement balloon, and the outer surface of the stent was pressed against the inner wall of the blood vessel. After 15 seconds,
The stent placement balloon was deflated. Shaft (4) so that the protection balloon (20) does not move.
While holding the last end (hand end) of (0), only the balloon catheter [I] for indwelling the stent is inserted into the catheter (10).
And withdrawn along the shaft (40).

Next, when the outer diameter at the time of inflation is 10 mm
A stent expansion balloon catheter [II] having a total length of 1350 mm and having a stent expansion balloon attached to the tip was inserted, and the stent expansion balloon was positioned at the site where the stent was placed. The operation for inserting the stent expansion balloon catheter [II] is performed using a shaft (4).
0) and along the catheter (10). Next, the stent was expanded by inflating a stent expansion balloon, and the outer surface of the stent was pressed against the inner wall of the blood vessel, thereby expanding the blood vessel to a conventional (normal) diameter. After 30 seconds, the balloon for stent expansion was deflated.

By injecting about 200 ml of physiological saline from the rear end side (hand side) of the guiding catheter, the blood retained on the front side of the protection balloon (20) was flushed to the external carotid artery side. . After removing the shaft (40) from the lumen of the catheter (10) and deflating the protection balloon (20), the balloon balloon for protection was removed together with the balloon catheter for stent expansion [II].

<Example 3> Using a balloon catheter device for protection having a structure as shown in Fig. 15, PTA including a balloon catheter exchange operation and stenting were performed.

[Configuration and Specifications of Protective Balloon Catheter Device] The catheter (10) constituting the protect balloon catheter device has an inner diameter of 0.5 mm with a stainless steel (SUS304) flat wire braided on the inner wall of a nylon elastomer. Consisting of a composite pipe with an outer diameter of 0.8 mm and a length of 1700 mm,
The outer surface is a vinylpyrrolidone copolymer (hydrophilic resin)
Was used. The distal end (11) of the catheter (10) is more flexible than the other parts, and the distal end (11) is provided with a contrast tip made of platinum.

The protection balloon (50) constituting the protection balloon catheter device includes:
A silicone rubber balloon having an opening (52A) at the tip and having an outer diameter of about 10 mm when inflated was used. A contrast tip (50C) made of platinum is provided at the tip of the balloon (50).

The shaft (70) constituting the balloon catheter device for protection has a length of 1900.
mm stainless steel (SUS304) wire was used. The tip (71) (about 70 to 150 mm from the tip) of the shaft (70) has a tapered cross-sectional shape, and a contrast coil (70C) made of platinum is welded to the tip (71). ing. The minimum diameter at the tip (71) is 0.2 mm and the maximum diameter is 0.4 mm.

The enlarged diameter portion (72) (about 1400 to 1600 mm from the tip) of the shaft (70) has a tapered cross-sectional shape, and the minimum diameter (d-α) of the enlarged diameter portion (72) is 0.35mm, maximum diameter (d + β) is 0.5
2 mm. In addition, the tip portion (71) and the enlarged diameter portion (72)
The diameter of the shaft (70) in between is 0.35 mm.

[PTA and Stenting] A guiding catheter was inserted into the internal carotid artery (a vascular site to be dilated) so as to open just before the stenosis site. A PTA balloon catheter having a total length of 1350 mm is inserted into the lumen of the guiding catheter, and the PTA balloon (the outer diameter at the time of inflation:
5 mm) at the site of the stenosis. Then, PTA
The balloon balloon device for protection was inserted into the lumen of the balloon catheter for protection, and the protection balloon (50) was positioned at a site closer to the peripheral blood vessel than the balloon for PTA.

The rear end opening (12A) of the catheter (10)
Is not blocked by the enlarged diameter portion (72) of the shaft (70) (the state shown in FIG. 16 (1)), and is contrasted from the side arm of the injection port (60) onto the lumen of the catheter (10). An agent is injected to inflate the protection balloon (50), and the rear end (63) is moved in a direction to release the compressive force on the rubber sleeve (65).
To reduce the tightening force of the rubber sleeve (65) on the outer periphery of the shaft (70),
0) The shaft (70) was advanced so that the rear end opening (12A) was air-tightly or liquid-tightly closed by the enlarged-diameter portion (72) (the state as shown in FIG. 16 (2)). At this time,
The opening (52A) of the protection balloon (50) is also air-tightly or liquid-tightly closed by the distal end (71) of the shaft (70).
The pressure in the lumen of 0) and the inside of the protection balloon (50) was maintained, and the blood flow from the internal carotid artery to the peripheral blood vessel was blocked by the inflated protection balloon (50).

By rotating the port body (62) in a direction to release the compressive force on the rubber sleeve (64),
The tightening force on the rear end (12) of the catheter (10) by the rubber sleeve (64) was reduced, and the injection port (60) was removed from the rear end (12) of the catheter (10).

After confirming that the blood flow flowing to the peripheral blood vessels is blocked by injecting the contrast agent from the rear end side (hand side) of the guiding catheter, the contrast agent is injected to remove the PTA balloon. The stenosis was pre-dilated by inflation (injection pressure 8 atm). After a lapse of 15 seconds, the PTA balloon was deflated.

While holding down the rear end (hand end) of the shaft (70) so that the protection balloon (50) would not move, only the PTA balloon catheter was pulled out along the catheter (10) and the shaft (70).

Next, a balloon having a stent mounted thereon (a balloon for indwelling a stent having an outer diameter of 7 mm at the time of inflation) is attached to the distal end and has a total length of 1350 mm.
Insert a stent placement balloon catheter [I],
The stent placement balloon was positioned at a stenosis site (pre-expanded site) to be expanded. The operation of inserting the stent placement balloon catheter [I] is performed by using a shaft (7).
0) and along the catheter (10). Next, the stent was expanded by inflating the stent placement balloon, and the outer surface of the stent was pressed against the inner wall of the blood vessel. After a lapse of 15 seconds, the stent placement balloon was deflated. While pressing the rearmost end (hand end) of the shaft (70) so that the protection balloon (50) does not move, only the stent placement balloon catheter [I] is inserted into the catheter (1).
0) and withdrawn along the shaft (70).

Then, a stent expansion balloon catheter [II] having a total length of 1350 mm and having a stent expansion balloon having an outer diameter of 9 mm at the time of inflation attached to the tip is inserted, and the stent is placed in the stent expansion balloon. Was located at the site. The insertion operation of the balloon catheter for stent expansion [II] is performed by the shaft (7).
0) and along the catheter (10). Next, the stent was expanded by inflating a stent expansion balloon, and the outer surface of the stent was pressed against the inner wall of the blood vessel, thereby expanding the blood vessel to a conventional (normal) diameter. After 30 seconds, the balloon for stent expansion was deflated.

By injecting about 200 ml of physiological saline from the rear end side (hand side) of the guiding catheter, the blood retained on the front side of the protection balloon (50) was flushed to the external carotid artery side. . With the protection balloon (50) and the catheter (10) fixed, the shaft (70) is retracted,
The protection balloon (50) was deflated. Next, the balloon catheter for protection was removed together with the balloon catheter for stent expansion [II].

[0140]

According to the balloon catheter apparatus of the present invention, the parent catheter can be exchanged (withdrawn and inserted) while the balloon is inflated. According to the balloon catheter device of the present invention and the balloon catheter system of the present invention provided with the balloon catheter device, the parent catheter can be used while the balloon (protection balloon) is inflated at a site closer to the peripheral blood vessel than the blood vessel site to be expanded. Certain dilatation balloon catheters can be replaced. As a result, there is no need to wash away the stagnant blood every time the dilatation balloon catheter is replaced, and the PTA
Further, simplification and speeding up of stenting can be achieved. In addition, since a new balloon catheter for dilatation can be inserted along the balloon catheter of the present invention, the operation for inserting the balloon catheter for dilatation can be easily performed.

[Brief description of the drawings]

FIG. 1 shows a balloon catheter device for protection and PT
It is explanatory drawing which shows the state combined with the balloon catheter apparatus for A.

FIG. 2 is an explanatory view schematically showing a procedure of PTA performed using the protection balloon catheter device shown in FIG.

FIG. 3 is an explanatory sectional view showing one embodiment of the balloon catheter device of the present invention.

4 is a partially enlarged view of the balloon catheter device shown in FIG.

FIG. 5 is an explanatory cross-sectional view showing a state when a valve provided in an injection port is closed.

FIG. 6 is an explanatory sectional view showing a modified example of the valve.

FIG. 7 is an explanatory sectional view showing a modification of the valve.

FIG. 8 is an explanatory sectional view showing a modified example of the valve.

FIG. 9 is an explanatory cross-sectional view showing a modified example of a tip portion of a shaft.

FIG. 10 is an explanatory cross-sectional view showing a modified example of a tip portion of a shaft.

FIG. 11 is an explanatory sectional view showing a modified example of the balloon catheter device according to one embodiment of the present invention.

FIG. 12 is an explanatory cross-sectional view showing a modified example of the balloon catheter device according to one embodiment of the present invention.

FIG. 13 is an explanatory cross-sectional view showing a state in which a distal end of a fluid injection adapter is inserted into a lumen of a catheter.

FIG. 14 is an explanatory sectional view showing a state in which an injection port has been removed from a rear end of a catheter.

FIG. 15 is an explanatory sectional view showing another embodiment of the balloon catheter device of the present invention.

16 is a partially enlarged view of the balloon catheter device shown in FIG.

FIG. 17 is an explanatory cross-sectional view showing a state where an extension shaft is connected to a rear end of the shaft.

FIG. 18 is an explanatory sectional view showing another embodiment of the balloon catheter device of the present invention.

19 is a partially enlarged view of the balloon catheter device shown in FIG.

[Explanation of symbols]

 REFERENCE SIGNS LIST 10 catheter 11 distal end of catheter 12 rear end of catheter 12A rear end opening 13 catheter 13A lumen 13B lumen 14A through hole 14B opening 15 catheter 16 through hole 17 end sleeve 18 guide wire 19 opening 20 protection balloon 20C imaging Tip 25 Protection Balloon 30 Injection Port 31 Injection Port Tip 32 Port Body 33 Rubber Sleeve 34 Adapter 35 Valve 35D Duck Bill Valve 36 Injection Port 37 Injection Port Tip 38 Port Body 39 Rotator 351 Rubber Sleeve 352 Rubber Sleeve 35S Slit Valve 40 Shaft 41 Shaft Tip 411 Shaft Tip 412 Shaft Tip 45 Shaft 46 Shaft tip 50 Protective balloon 51 Balloon body 52 Cylindrical part 52A Opening 50C Imaging tip 60 Injection port 61 Injection port tip 62 Port body 63 Rear end of injection port 64 Rubber sleeve 65 Rubber sleeve 70 Shaft 71 Shaft tip 72 Large diameter portion 73 Extension shaft 74 Extension shaft tip 75 Shaft rear end 76 Shaft rear end 77 Extension shaft 78 Extension shaft tip 70C Imaging coil 80 Catheter 81 Catheter tip 82 Catheter Rear end part 82 rear end opening 83 valve 90 injection port 91 tip part of injection port

Claims (16)

[Claims] 1. A catheter (10), a balloon (20) attached to a distal end (11) of the catheter (10), and a chuck mechanism for holding a rear end (12) of the catheter (10). The chuck mechanism has an injection port (30) detachably attached to a rear end (12) of the catheter (10), and a rear end opening (12A) of the catheter (10) airtight or liquid. It has a tip (41) inserted into the lumen of the catheter (10) so as to close it tightly.
The shaft (4) connected to the rear end (12) of the catheter (10) by inserting the catheter (1) into the lumen.
(0). 2. The balloon catheter device according to claim 1, wherein a valve (35) for maintaining a pressure in a lumen of the catheter (10) is provided in the injection port (30), and the valve (35) is provided. ) Is a balloon catheter device characterized in that it can be closed when the shaft (40) is removed from the rear end (12) of the catheter (10). 3. The balloon catheter device according to claim 1, wherein an extension shaft is connected to a rear end of the shaft. 4. A catheter (10), mounted on a distal end (11) of the catheter (10),
It has a balloon (50) having an opening (52A) at the distal end, and a chuck mechanism for holding a rear end (12) of the catheter (10). With this chuck mechanism, the rear end ( An injection port (60) detachably attached to the injection port (60); a lumen (5) inserted into the injection port (60), the lumen of the catheter (10) and the balloon (5);
And a shaft (70) penetrating through the inside of the balloon (50). The shaft (70) is configured to air-tightly or liquid-tightly close the opening (52A) of the balloon (50).
2A) and a tip (71) protruding from the tip (7).
When 1) is closing the opening (52A) of the balloon (50), the rear end opening (12) of the catheter (10) is closed.
A) The enlarged diameter portion (7) capable of sealing air-tight or liquid-tight
2) A balloon catheter device comprising: 5. The balloon catheter device according to claim 4, wherein an extension shaft is connected to a rear end of the shaft. 6. A catheter (80), a balloon (20) attached to a distal end (81) of the catheter (80), and a catheter (80) inserted into a lumen through a rear end opening (82A). The tip (91) has a
An injection port (90) attached to the rear end (82) of the catheter (80) by inserting the catheter (1) into the lumen. The catheter (80) includes the balloon. A valve (83) for maintaining the internal pressure of (20) is provided. The valve (83) opens when the injection port (90) is attached, and opens when the injection port (90) is removed. A balloon catheter device having a closed structure. 7. A balloon catheter device according to claim 1 or claim 2, the length of the catheter (10) and L _10, when the length of the shaft (40) and L _40, the following A balloon catheter device which satisfies the condition shown in the formula. Formula: 0.3 ≦ (L ₄₀ / L ₁₀ ) 8. A balloon catheter device according to claim 3, the catheter a length of (10) and L _10, the length L ₄₀₊ when the extension shaft is coupled with the shaft (40) A balloon catheter device characterized by satisfying the following formula when _E is satisfied. Formula: 0.3 ≦ (L _{40 + E} / L ₁₀ ) 9. A balloon catheter device according to claim 4, when the length of the catheter (10) and L _10, the length of the shaft (70) and L _70, the conditions shown in the following formula A balloon catheter device characterized by satisfying the following. Formula: 1.3 ≦ (L ₇₀ / L ₁₀ ) 10. The balloon catheter device according to claim 5, wherein the length of the catheter (10) is L ₁₀ ,
A balloon catheter device characterized by satisfying a condition represented by the following expression, where L70 _{+ E} is the length when the shaft (70) and the extension shaft are connected. Formula: 1.3 ≦ (L _{70 + E} / L ₁₀ ) 11. A balloon catheter system, wherein the balloon catheter device according to any one of claims 1 to 10 is inserted into a lumen of a dilatation balloon catheter. 12. The balloon catheter device according to claim 1 or 2 is inserted through the lumen of the dilatation balloon catheter, and the length of the balloon catheter device when the catheter and the shaft are connected to each other. When the length is L _{10 + 40} and the total length of the balloon balloon for expansion is Le, the balloon catheter system satisfies the condition shown in the following equation. Formula: 1.5 ≦ (L _{10 + 40} / Le) 13. The length of the balloon catheter device according to claim 3, which is inserted into the lumen of the balloon catheter for expansion, and the length of the catheter constituting the balloon catheter device, the shaft, and the extension shaft are connected. Where L _{10 + 40 + E} and the total length of the balloon balloon for expansion is Le, the following formula is satisfied. Formula: 1.5 ≦ (L _{10 + 40 + E} / Le) 14. balloon catheter device according to claim 4 will be inserted into the lumen of the dilatation balloon catheter, the length of the shaft constituting the balloon catheter device and L _70, of the expansion balloon catheter A balloon catheter system which satisfies a condition represented by the following equation when the total length is Le. Formula: 1.5 ≦ (L ₇₀ / Le) 15. The balloon catheter device according to claim 5, which is inserted into a lumen of a dilatation balloon catheter, and has a length L when a shaft constituting the balloon catheter device and an extension shaft are connected to each other. _{70 + E} ,
When the total length of the balloon catheter for expansion is Le, the balloon catheter system satisfies the condition shown in the following equation. Formula: 1.5 ≦ (L _{70 + E} / Le) 16. become by balloon catheter device according to any one of claims 1 to 5 is inserted into the lumen of the dilatation balloon catheter, the length of the catheter which forms the balloon catheter device and L ₁₀ The balloon catheter system according to claim 1, wherein when the overall length of the balloon catheter for expansion is Le, the condition shown in the following equation is satisfied. Formula: 1.5 ≧ (L ₁₀ / Le)