JPH07289643A - Baloon catheter and stent feeder - Google Patents

Abstract

PURPOSE: To provide a balloon catheter having high flexibility, easy to manufacture, and easy to use. CONSTITUTION: The balloon catheter 1 has a tubular shaft 3 having a base end and a tip, a slender expansion balloon 5 attached in the vicinity of the tip of the tubular shaft 3 which also has a tip and a base end, and a sleeve 12 fixed to the tubular shaft 3 so as to prevent the expansion of a part of the balloon 5. The tubular shaft 3 has a guide wire lumen 8, the guide wire lumen 8 has an entrance 9 for the guide wire 10 formed at the tip side of the balloon 5, and an outlet 11 for the guide wire 10 formed at the tip side of the base end of the tubular shaft 3. The sleeve 12 is attached to the tubular shaft 3 at the tip side of the outlet 11 in the case of the outlet 11 for the guide wire 10 is on the side of the base end of the balloon 5, and is attached to the tubular shaft at the base side of the outlet in the case of the outlet 11 for the guide wire 10 is on the tip side.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a balloon catheter, which comprises a tubular shaft having a proximal end and a distal end, an elongated dilatation balloon provided near the distal end of the tubular shaft, and a portion of the balloon. Means secured to the tubular shaft to prevent expansion of the.

The present invention also relates to a stent delivery device for a balloon-expandable stent, the stent delivery device comprising a balloon catheter, the balloon catheter having a tubular shaft having a proximal end and a distal end, and the tubular catheter. And an elongated dilatation balloon provided near the tip of the shaft.

[0003]

Balloon catheter technology uses constant length balloons, and therefore many medical procedures that require balloon catheter technology rely on several catheters having different length balloons. There is a need to. For example, if a procedure requires two balloons of different sizes, it may be necessary to either replace the balloon catheter or actuate one usable balloon length in sequence. Replacing a balloon catheter is costly, while sequential actuation of available balloon lengths is time consuming and can potentially lead to patient injury and inadequate dilation. This is a dangerous operation.

A balloon catheter is a mechanism for carrying and applying a balloon-expandable prosthesis called a stent in order to maintain the function of blood vessels.
It is a commonly used instrument. The length of the balloon must be selected as a function of the length of the stent to avoid inadequate expansion of the stent or damage to the vessel. This can also be expensive as it requires multiple balloon catheters to properly and safely deliver the stent.

US Pat. No. 5,246,421 refers to a method of treating an occluded region of a body passageway that allows the use of a balloon catheter having an adjustable length balloon. Accordingly, the above U.S. patent uses a balloon catheter that externally steers an adjustable sheath to partially enclose and contain a portion of the dilatation balloon of the catheter in situ during the treatment procedure. Is teaching. Various balloon lengths can be obtained by external manipulation by sliding the sheath back and forth to inflate a predetermined length of the balloon portion before inflating the balloon. The catheter body may comprise an elongate tube and a balloon with both neck portions attached to the elongate tube at two axially spaced locations, the catheter also defining a lumen. A catheter body may be provided, the balloon terminating such body as a one-piece, one-piece assembly having a closed end. The above-identified US patents contemplate that the technology disclosed therein is compatible with virtually all catheter constructions, including over-wire catheters (catheters that surround a wire) and fixed-wire catheters. , It can be changed. To prevent creeping of the sheath during and after inflation of the balloon and to cover more balloons than originally selected, position the sheath before it is inflated, for example using a clamping device. Can be securely fixed. The fact that the sheath is manipulated externally adds considerable complexity to the construction of the catheter and poses the risk of occluding the sheath. Also, the device is relatively cumbersome and has high rigidity due to the overlapping elements due to external manipulation of the sheath around the shaft of the catheter, which is related to the treatment of tortuous or narrow vessels. , It may cause some difficulty. Also, problems of friction between the sheath and the sheath of the catheter may occur, which also makes manipulation of the sheath from the outside difficult. The US patent does not suggest that the moving sheath and the resulting variable length balloon catheter are feasible as a device that meets the balloon length requirements for stent delivery. .

[0006]

SUMMARY OF THE INVENTION It is an object of the present invention to overcome the drawbacks and limitations of the prior art as described above by providing a balloon catheter which is highly flexible, easy to manufacture and easy to use. Is.

Another object of the present invention is to provide a stent delivery device which is also flexible, easy to manufacture and easy to use.

[0008]

[MEANS FOR SOLVING THE PROBLEMS] A basic use of a balloon catheter, that is, for expanding a stenosis or for supplying a balloon-expandable stent, the monorail (MONORAIL: trade name)
It is extremely simple and easy to change the length of the balloon, while making full use of the advantages of the technique known as "quickly, efficiently and widely implemented". A means for preventing inflation of a portion of the balloon during the introduction, withdrawal or use of a balloon catheter with respect to dilation of the stenosis or delivery of the stent into the blood vessel of a patient,
There is no external control. The construction of the balloon catheter remains simple and does not consume a lot of elements that are overlaid with the tubular shaft. Also, there is no friction that causes movement of the elements.

In practice, for the purpose of dilating a stenosis, the physician may simply modify a standard balloon catheter or dilate it first with a first length balloon before dilating the stenosis. And then, as usual,
Along the guide wire, the balloon catheter is withdrawn and the working length of the balloon is altered by attaching a means to the tubular shaft to prevent inflation of a portion of the balloon, and then, as usual, a balloon catheter. Can be passed around the guide wire to quickly reach the stenosis to be treated with a shorter length balloon. For the purpose of delivering the stent, the physician modifies the standard balloon catheter to deliver the stent into the dilated stricture, or dilates the stricture with an available dilatation balloon. Then withdraw the balloon catheter over the guide wire, attach a means to the catheter shaft to prevent inflation of the balloon portion, attach the deflated stent to the appropriate balloon portion, then As usual, the stent can be expanded by passing a balloon catheter loaded with the stent around the guide wire to reach the required site or site of the patient's blood vessel and inflating the balloon. .

The means for preventing inflation of a portion of the balloon can be removably or permanently attached to the tubular shaft. The removable means is
Allowing the physician to select balloon lengths and exchanging inflation arresting means to allow the physician's requirements to be met based on standard balloon lengths. The permanently attached means allows the number of balloon sizes to be reduced by mounting a series of balloon catheters with standard sized balloons with different inflation arresting means.

The expansion inhibiting means comprises a sleeve having a proximal end and a distal end, one of the proximal end and the distal end enclosing a portion of the tubular shaft near the balloon and the other of the proximal end and the distal end of the balloon. If partly enclosed, the expansion arresting means can be realized very economically, and
The sleeve can be permanently or removably attached to the tubular body for a series of balloon catheters with standard sized balloons, for example by providing a set of sleeves of different lengths to provide different Inflation of the balloon portion of length can be prevented.

A simple, efficient and inexpensive mounting of the sleeve is achieved by means of a latch, which cooperates with the catch means to enclose one end of the sleeve in a tubular shape surrounded by this one end. Attach to the shaft part. To enclose a portion of the balloon to protect the wall of the vessel from a jet of fluid, which can result from the balloon rupturing due to the very high pressures required to expand the stent. Of elastic balloon jacket means are provided. The jacket means has a proximal end and a distal end, one of the proximal end and the distal end attached to a tubular shaft, and the other of the proximal end and the distal end prevents inflation of a portion of the balloon. Attached to the means. In this way, the elastic jacket means cushions the jets created by balloon rupture and protects the vessel wall. The jacket means also protects the balloon skin or membrane from rupture that may be caused by a sharp edged stent. When the balloon is deflated, the jacket means assists in the folding of the balloon.

The above and other objects will be more readily understood by reading the following detailed description with reference to the drawings, which schematically show, by way of example only, various embodiments of the invention.

[0014]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The stent delivery system shown in FIG. 1 comprises a balloon catheter 1 adapted to handle a balloon-expandable stent 2 in a living vessel, such as a coronary artery. The balloon catheter comprises a tubular shaft 3 having a proximal end (not shown) and a distal end 4. An elongated dilatation balloon (shown inflated) 5 having a proximal end 6 and a distal end 7 is provided near the distal end 4 of a tubular shaft 3. Balloon 5
Is attached to the tubular shaft in a manner that is common in the art.

The tubular shaft 3 has a fluid supply lumen 21 for inflating a balloon and a guide wire lumen 8. The guide wire lumen 8 is provided on the distal end side of the balloon 5. It has an inlet 9 for the guide wire 10 and an outlet 11 for the guide wire 10 provided on the distal end side of the proximal end (not shown) of the tubular shaft 3.

A means for preventing inflation of the balloon portion is provided with a guide wire 10 provided on the proximal end side of the balloon 5.
It is attached to the tubular shaft 3 at the distal end side of the outlet 11 for use. Such means for preventing inflation of the balloon portion comprises a non-inflatable or inextensible sleeve 12 mounted on the tubular shaft 3, the non-inflatable sleeve 12 having a proximal end. 13 and tip 14
have. The tip 14 of the sleeve 12 has a balloon 5
It surrounds a portion 15 of the proximal end 6 to prevent inflation of the balloon.

The base end 13 of the sleeve 12 surrounds a part of the tubular shaft 3. The proximal end 13 of the sleeve comprises a circular constriction 16 (FIG. 3) which engages a corresponding circular groove 17 in the tubular shaft 3 to secure the proximal end of the sleeve 12 relative to the tubular shaft 3. Moreover, it is detachably attached. Therefore, the sleeve 12 is prevented from moving during inflation of the balloon and during insertion and withdrawal of the catheter 1 into and from a blood vessel of a living body.

The balloon jacket 18 having elasticity is
It surrounds part of the balloon 5. The balloon jacket 18 is attached to the tip 1 of the sleeve 12 by, for example, bonding.
It has a base end 19 attached to 4 and a tip 20 for elastically tightening the tip of the tubular shaft 3 at the position of the tip 7 of the balloon 5.

The balloon expandable stent 2 is provided in the balloon jacket 18 in a manner generally known in the art for balloon delivering a balloon expandable stent.

To attach the sleeve 12 to the balloon catheter 1, the sleeve is engaged around the tip of the balloon catheter and the sleeve and catheter are used until the constriction 16 snaps into the groove 17. Just slide along. The sleeve can be removed by performing the opposite operation.

The balloon catheter 31 shown in FIG. 2 comprises a tubular shaft 32 having a proximal end (not shown) and a distal end 33. An elongated dilatation balloon (shown inflated) with a proximal end 35 and a distal end 36 3
4 is provided near the tip 33 of the tubular shaft 32,
Bonded in the usual manner.

The tubular shaft 32 has an inflation lumen 37 for the balloon 34 and a guide wire lumen 38, which is provided at the distal end side of the balloon 34 and has a guide wire 40. And an outlet 39 for the guide wire 40, which is provided on the distal side of the proximal end (not shown) of the tubular shaft 32.

Means for preventing inflation of the balloon portion is attached to the tubular shaft 32, which is located proximal of the outlet 41 for the guidewire 40 and distal of the balloon 34. ing. The means for preventing inflation of the balloon portion comprises a non-inflatable or inextensible sleeve 42 mounted on the tubular shaft 32, which sleeve 42 comprises a proximal end 43 and a distal end 4.
Have four. The proximal end 43 of the sleeve 42 surrounds a portion 45 of the distal end 36 of the balloon 34 and prevents inflation of the balloon. The tip end 44 of the sleeve 42 surrounds a part of the tubular shaft 32. Tip 4 of sleeve 42
4 is a circular constriction (also shown in FIG. 3) 46 that engages a corresponding circular groove 47 in the tubular shaft 32.
The tip of the sleeve 42 is firmly and removably attached to the tubular shaft 32. Therefore, the movement of the sleeve is prevented during inflation of the balloon, insertion of the balloon catheter 31 into the blood vessel of the living body, and withdrawal of the balloon catheter 31 from the blood vessel of the living body.

With respect to the stent delivery device of FIG. 1, until the sleeve 42 is engaged around the distal end of the tubular shaft 32 and the constriction 46 snaps into the circular groove 47,
The sleeve 42 can be attached to the balloon catheter 31 simply by sliding the sleeve along the tubular shaft and the distal end 36 of the balloon 34. The sleeve can be removed by performing the opposite movement.

Various modifications may be considered without departing from the scope of the invention.

For example, the stent delivery system of FIG. 1 can be used as a balloon catheter for dilating a stenosis, with or without a balloon jacket. Similarly, the balloon catheter of Figure 2 can be used as a stent delivery device with or without the addition of a balloon jacket.

The balloon jacket 18 shown in FIG. 1 can alternatively be mounted on the tubular shaft 3.
For example, the distal end 20 may be adhered at the position of the distal end 7 of the balloon 5, and the proximal end 19 thereof may be elastically tightened at the position of the proximal end 6 of the balloon 5 at the distal end of the tubular shaft 3. it can.

Using other combinations of catching means,
The contracting portion 16 (46) and the groove 17 shown in FIGS. 1 and 2
Instead of (47), one end of the sleeve 12 (42) can be attached to the tubular shaft 3 (32).
For example, as shown in FIG. 4, a circular rib 50 that cooperates with the circular groove 51 of the sleeve 12 (42) may be provided on the tubular shaft 3 (32). Alternatively, as shown in FIG. 5, a round circular rib 52 is formed on the tubular shaft 3 (32), and an embossed portion (expansion portion) 53 having a shape corresponding to the rib and cooperating with the rib. Can also be provided on the sleeve 12 (42). In addition, two ribs cooperating with one rib to allow the position of the sleeve to be selected.
Alternatively, more grooves can be provided. It is also possible to provide the tubular shaft and the corresponding end of the sleeve with threaded parts that fit together. Further, using a belt (FIG. 6) 54 for tightening the sleeve 12 (42),
The sleeve is fitted into the corresponding groove 55 of the tubular shaft 3 (32).
It can also be transformed into.

If the sleeve needs to be permanently attached to the tubular shaft, such permanent attachment can be accomplished by gluing or welding the corresponding portions of the sleeve.

The means for preventing inflation of a portion of the balloon can take forms other than sleeves, for example:
If the exit for the guidewire is proximal to the balloon, provide a clamp distal to such exit, and if the exit for the guidewire is distal to the balloon. May have a clamp proximal to such an outlet.

[Brief description of drawings]

FIG. 1 is a cross-sectional view of a stent delivery device embodying the present invention.

FIG. 2 is a cross-sectional view of a balloon catheter embodying the present invention.

FIG. 3 is a detailed cross-sectional view of the stent delivery device of FIG. 1 or the balloon catheter of FIG.

FIG. 4 is a cross-sectional view showing a modified example of details of FIG.

5 is a cross-sectional view showing another modification of the details of FIG.

FIG. 6 is a cross-sectional view showing yet another modification of the details of FIG.

[Explanation of symbols]

 1, 31 balloon catheter 3, 32 tubular shaft 5, 34 dilatation balloon 8, 38 guide wire lumen 9, 39 inlet 10, 40 guide wire 11, 41 outlet 12, 42 sleeve (balloon expansion inhibiting means) 13, 43 bases End 14,44 Tip 16,46,50,52,54 Latch means 17,47,51,53,55 Catch means 18 Balloon jacket

Claims (12)

[Claims] 1. A tubular shaft (3, 32) having a proximal end and a distal end, which is used as a balloon catheter (1, 31).
An elongated dilatation balloon (5, 34) having a distal end and a proximal end and mounted near the distal end of the tubular shaft, and the tubular shaft (3, 34) to prevent inflation of a portion of the balloon. 32) a balloon catheter comprising means (12, 42) fixed to said guide shaft, said tubular shaft (3, 32) comprising a guide wire lumen (8, 38). The cavity is
An inlet (9, 39) for the guide wire (10, 40) provided on the distal side of the balloon (5, 34) and a proximal side of the proximal end of the tubular shaft (3, 32); Outlet (11, for the guide wire (10, 40)
41) and the means (12, 42) for preventing inflation of a portion of the balloon comprises: an outlet (11) for the guide wire (10);
The proximal side of the outlet (11) is attached to the tubular shaft (3) on the distal side of the outlet (11), and the outlet (41) for the guide wire (40) is the balloon ( 34) on the distal side of the tubular shaft (3) at the proximal side of the outlet (41).
Balloon catheter characterized by being attached to 2). 2. A balloon catheter according to claim 1, wherein means (12, 42) for inhibiting inflation of a portion of the balloon are removably attached to the tubular shaft (3, 32). A balloon catheter characterized in that 3. The balloon catheter of claim 1, wherein the means (12, 42) for inhibiting inflation of a portion of the balloon is permanently attached to the tubular shaft (3, 32). A balloon catheter characterized in that 4. The balloon catheter of claim 1, wherein the means for inhibiting inflation of a portion of the balloon has a sleeve (12,42) having a proximal end (13,43) and a distal end (14,44). ), One of the proximal end and the distal end encloses a portion of the tubular shaft (3, 32) in the vicinity of the balloon (5, 34),
The other of the proximal end and the distal end is the balloon (5, 34)
A balloon catheter characterized by surrounding a part of the balloon. 5. The balloon catheter according to claim 4, wherein said one end of said sleeve (12, 42) is surrounded by said one end in cooperation with catching means (17, 47, 51, 53, 55). Tubular shaft (3, 32)
Latch means (16, 46,
50, 52, 54). 6. The balloon catheter of claim 1, further comprising elastic balloon jacket means (18) for surrounding a portion of the balloon (5),
The balloon jacket means has a proximal end and a distal end, one of the proximal end and the distal end being attached to the tubular shaft (3), and the other of the proximal end and the distal end of the balloon. A balloon catheter adapted to be attached to a means for preventing inflation of a portion. 7. A stent delivery device for a balloon expandable stent (2) comprising a balloon catheter (1, 31), the balloon catheter having a tubular shaft (3, 3) having a proximal end and a distal end. 32), and an elongated dilatation balloon (5, 34) having a distal end and a proximal end and attached near the distal end of the tubular shaft, the tubular shaft (3, 32) Comprises a guide wire lumen (8, 38), the guide wire lumen comprising:
An inlet (9, 39) for the guide wire (10, 40) provided on the distal side of the balloon (5, 34) and a proximal side of the proximal end of the tubular shaft (3, 32); Outlet (11, for the guide wire (10, 40)
41) and the means (12, 42) for preventing inflation of a portion of the balloon comprises: an outlet (11) for the guide wire (10);
The proximal side of the outlet (11) is attached to the tubular shaft (3) on the distal side of the outlet (11), and the outlet (41) for the guide wire (40) is the balloon ( 34) on the distal side of the tubular shaft (3) at the proximal side of the outlet (41).
2) A stent supply device characterized by being attached to 8. The stent supply device according to claim 7, wherein
Means (1) for preventing inflation of a portion of the balloon
2, 42) is detachably attached to said tubular shaft (3, 32). 9. The stent supply device according to claim 7, wherein
Means (1) for preventing inflation of a portion of the balloon
2, 42) is permanently attached to said tubular shaft (3, 32). 10. The stent delivery device of claim 7, wherein the means for preventing inflation of a portion of the balloon comprises a sleeve (12, 42) having a proximal end (13, 43) and a distal end (14, 44). 42), wherein one of the proximal end and the distal end surrounds a portion of the tubular shaft (3, 32) in the vicinity of the balloon (5, 34),
The other of the proximal end and the distal end is the balloon (5, 34)
A stent supply device characterized in that it surrounds a part of the stent. 11. The stent delivery device of claim 10, cooperating with catching means (17, 47, 51, 53, 55) such that one end of the sleeve (12, 42) is surrounded by the one end. The tubular shaft (3, 32)
Latch means (16, 46,
50, 52, 54) is further provided. 12. The stent delivery device of claim 7, further comprising elastic balloon jacket means (18) for surrounding a portion of the balloon (5),
The balloon jacket means has a proximal end and a distal end, one of the proximal end and the distal end being attached to the tubular shaft (3), and the other of the proximal end and the distal end of the balloon. A stent delivery device adapted to be attached to a means for inhibiting expansion of a portion.