WO2006093273A1

WO2006093273A1 - Double balloon catheter

Info

Publication number: WO2006093273A1
Application number: PCT/JP2006/304105
Authority: WO
Inventors: Keiichi Kagami; Eiji Ueda; Jiro Hara; Satoshi Saito; Noboru Fukuda; Shinichiro Yokoyama
Original assignee: Goodman Co., Ltd.; Gentier Biosystems, Inc.
Priority date: 2005-03-03
Filing date: 2006-03-03
Publication date: 2006-09-08
Also published as: JPWO2006093273A1; JP4778956B2; JP2008173137A

Abstract

[PROBLEMS] To provide a double balloon catheter by which a blood flow (perfusion) in a sufficient amount is ensured in a part other than the site under a treatment even in the case of blowing up balloons and operations such as the injection of a liquid drug, etc. into the site under the treatment can be easily conducted by efficiently retaining sectional areas of lumens. [MEANS FOR SOLVING PROBLEMS] At a boundary (around the line X-X) located in the basal side of a perfusion hole (12), the sectional area of a first lumen (4) for a guide wire, the sectional area of a second lumen (5) for a balloon and the sectional area of a third lumen (7) for injecting a liquid drug, etc. are changed between the front side and the basal side of a tube body (1) so that the first lumen (4) has a larger sectional area in the front side than in the basal side while the second lumen (5) and the third lumen (7) have smaller sectional areas in the front side than in the basal side.

Description

Specification

Dub Nore Nolane Force Tete Nore

Technical field

The present invention relates to a double balloon catheter that is a catheter having two balloons at the tip.

Background art

[0002] As a conventional double vanolene catheter, one described in Patent Document 1 below is known. This catheter is formed independently of each other with the same cross-sectional area for lumen expansion, for guide wire insertion, or for injection of chemicals or the like. Patent Document 1: JP-A-11 164891

Disclosure of the invention

Problems to be solved by the invention

[0003] In the double balloon catheter described above, the lumen for injecting the drug solution and the other three lumens is provided together with the other three lumens even though the outer diameter of the catheter body is limited. In some cases, the working time may be increased due to viscous resistance, and a relatively large amount of chemical solution cannot be injected quickly. Alternatively, in the double balloon catheter, the cross-sectional area of each balloon expansion lumen is relatively small, and in some cases, it takes time to expand the balloon. In the double balloon catheter, when the distal or proximal balloon is expanded and the blood vessel is pressed, blood flow stops at that portion, so that the balloon cannot be expanded for a long time.

[0004] Therefore, the present invention can secure a sufficient amount of blood flow (perfusion) other than the treatment site even when the balloon is expanded, and by efficiently securing the cross-sectional area of the lumen, The purpose is to provide a double balloon catheter that facilitates operations such as injection of chemicals.

Means for solving the problem

[0005] In order to achieve the above object, the invention of claim 1 includes a tube main body, and an inside of the tube main body. The first lumen that is open to the tip of the tube body and through which a guide wire can be inserted, and the first lumen that is formed at regular intervals on the outer peripheral wall of the tip end of the tube body.

A first side hole and a second side hole; and a second lumen formed in the tube main body and communicating with the first side hole and the second side hole; the first side hole and the second side hole; Formed on the outer peripheral wall of the tube main body between the first balloon and the second balloon, and between the first balloon and the second balloon installed around the outer periphery of the tube main body so as to cover each of the side holes. A third side hole formed in the tube main body, communicated with the third side hole, formed on an outer peripheral wall of the tube main body on a proximal side from the second balloon, and A perforation hole communicating with the one lumen, and at a boundary disposed on the proximal side of the perfusion hole, the cross-sectional area of the first lumen and at least one of the second lumen and the third lumen The area is the tip side of the tube body and The first lumen has a larger cross-sectional area on the distal end side than the proximal end side, and at least one of the second lumen or the third lumen is located on the distal end side with respect to the proximal end side. A feature is that the cross-sectional area is reduced.

[0006] In addition to the above object, in order to achieve the object of enabling each balloon to be individually expanded, the invention of claim 2 is that in the above invention, each tube body is replaced with the second lumen. A second A lumen and a second B lumen formed therein, wherein the second A lumen communicates only with the first side hole, and the second B lumen communicates only with the second side hole. The cross-sectional area of the first lumen and the cross-sectional area of at least one of the second A lumen, the second B lumen, or the third lumen at the boundary located on the proximal side from the perfusion hole It changes between the distal end side and the proximal end side of the tube main body, and the first lumen is one of the second A lumen, the second B lumen, or the third lumen whose sectional area on the distal end side is larger than the proximal end side. At least one of the cross sections on the distal end side with respect to the proximal end side Characterized in that is so that configurations smaller.

[0007] Further, in addition to the above object, in order to achieve the object of increasing the amount of perfusion and reducing the resistance smoothly, the invention according to claim 3 is characterized in that the tip of the first invention is more advanced than the first balloon. It has a perfusion assisting hole formed on the outer peripheral wall of the tube body on the side and communicating with the first lumen. [0008] Furthermore, in addition to the above object, in order to achieve the object of further smoothing the guide wire insertion and fluid flow, the invention of claim 4 is the above invention, wherein The sectional area of at least one lumen is gradually changed.

[0009] In addition to the above object, in order to achieve an object of easy manufacture at low cost and enhancing operability and safety, the invention according to claim 5 is characterized in that, The side portion and the base end portion are formed of separate members, and these members are bonded or fused to each other.

[0010] Further, in addition to the above object, in order to achieve the object of further improving the operability and safety by gradually changing the flexibility, the invention according to claim 6 is characterized in that in the above invention, The side portion and the base end portion are connected to each other at a joining surface that forms an acute angle with respect to the axis of the tube main body, and are adhered or fused to each other.

The invention's effect

[0011] In this double balloon catheter, a large lumen area through which blood in the catheter is perfused can be secured, so that sufficient perfused blood can be secured and treatment can be performed safely. Since it is possible to suppress the influence of resistance to a small level, it is possible to efficiently perform the operation of performing injection and performing the operation, which is extremely useful as a medical device.

BEST MODE FOR CARRYING OUT THE INVENTION

Hereinafter, embodiments according to the present invention will be described with reference to the drawings as appropriate.

[0013] [First embodiment]

FIG. 1 is an overall explanatory view of a double balloon catheter (W1) according to a first embodiment of the present invention, FIG. 2 (a) is a schematic cross-sectional view of the tip side of the double balloon catheter (W1), and FIG.

) And (c) are cross-sectional views taken along lines A-A and B-B.

[0014] This double balloon catheter (W1) is a tube body extending from the distal end to the proximal end edge.

(1), port connection part (la) continuous with the base end of the tube body (1), balloon port (lb) connected to the port connection part (la), drug solution port (lc), guide wire Port (Id).

[0015] The tube body (1) includes a first lumen (4) communicating with the guide wire port (Id), and a bar A second lumen (5) communicating with the rune port (lb) and a third lumen (7) communicating with the chemical port (lc) are arranged.

[0016] The first lumen (4) opens to the tip of the tube body (1). The tube body

(1) A first side hole (8) and a second side hole (9) are formed on the outer peripheral wall of the front end edge at regular intervals. The second lumen (5) communicates with the first side hole (8) and the second side hole (9). In addition, a first balloon (2) and a second balane (3) are installed around the outer periphery of the tube body (1) in a state of covering each of the first side hole (8) and the second side hole (9). I'm going.

[0017] A third side hole (10) is formed in the outer peripheral wall of the tube body (1) between the first balloon (2) and the second balloon (3). The third lumen (7) communicates with this third side hole (10).

[0018] Further, a perfusion auxiliary hole (1 1) formed on the outer peripheral wall of the tube body (1) on the distal end side from the first balloon (2) and communicating with the first lumen (4), and a second balloon (3 ) On the outer peripheral wall of the tube main body (1) on the proximal end side, and a perfusion hole (12) communicating with the first lumen (4) is provided.

[0019] Then, the cross-sectional area of each lumen changes with the portion immediately on the proximal end side of the perfusion hole (12) (the portion around the X-X line in the figure) as a boundary. That is, the first lumen (4) has a larger cross-sectional area on the distal end side than a cross-sectional area on the proximal end side from the boundary. The cross-sectional area on the proximal end side of the first lumen (4) is almost the same as the outer diameter of the guide wire. The second lumen (5) and the third lumen (7) have a smaller sectional area on the distal end side than the sectional area on the proximal end side from the boundary.

[0020] It should be noted that, at the boundary, each lumen is formed in a tapered shape, and therefore, the cross-sectional area of each lumen is configured to gradually change. In addition, the double balloon catheter (W1) is formed by separating the base end side from the X-X line and the front end side from the X-X line, and these members are bonded or bonded together.

[0021] The double balloon catheter (W1) described above is mainly used as follows. That is, a guide wire is introduced to the treatment site by a known method in advance, and the proximal end of the guide wire is inserted into the distal end of the first lumen (4). Advance the double balloon catheter (W1) along the guide wire so that the treatment site is located between the first balloon (2) and the second balloon (3). Pull the guide wire to the border (or the proximal side).

[0022] Then, the fluid injector connected to the balloon port (lb) is operated to expand the first balloon (2) and the second vanolene (3). At this time, the treatment site is blocked between both balloons, but the blood flow is between the first lumen (4) tip or between the perfusion assistance hole (11) and the perfusion hole (12), that is, the first lumen. Secured at the cross-sectional area enlargement (4) (perfusion).

[0023] Thereafter, the device connected to the drug solution port (lc) is operated to inject the drug solution or the like from the third side hole (10) between the balloons, or to collect blood or the like. Then, the balloon is deflated, the double balloon catheter (W1) is pulled out, and the guide wire is pulled out.

[0024] In the double vanolane catheter (W1) described above, the first lumen (4) has a larger cross-sectional area on the distal end side than the proximal end side, so that a sufficient blood flow rate in perfusion can be secured. In addition, blood can be circulated smoothly by reducing the viscous resistance of blood flow. Moreover, since the cross-sectional area of the first lumen (4) changes at the boundary, the position where the guide wire is pulled during the treatment is easy to understand. Furthermore, since the cross-sectional area of the proximal end side of the first lumen (4) is almost the same as the outer diameter of the guide wire, the double balloon catheter (W1) can be easily introduced during the operation, and it can be easily introduced during surgery. Perfusion can be facilitated by sealing the blood inflow to the proximal end with a guide wire.

[0025] Since the second lumen (5) and the third lumen (7) have a smaller sectional area on the distal end side than the sectional area on the proximal end side, the sectional area on the distal end side is wide. In combination with the first lumen (4), the outer diameter of the tube body (1) (except the tip) can be changed, and it can be much more proximal than the boundary of the tube body (1). In this part, the second lumen (5) and the third lumen (7) can have a large cross-sectional area, and a chemical solution or a balloon expansion fluid can be smoothly injected in a state of low resistance. .

[0026] Further, since the outer peripheral wall of the tube body (1) on the distal end side from the first balloon (2) has a perfusion auxiliary hole (11) formed in a state communicating with the first lumen, the perfusion can be performed. A large amount of blood flow can be ensured in a state of even less resistance. In addition, since the cross-sectional area of each lumen gradually changes, the guide wire and each fluid can smoothly pass through the boundary (cross-sectional area changing portion), improving operability and safety. In addition, the tip side and base end side parts from the boundary are composed of separate members that are bonded or bonded to each other. Therefore, it is possible to enhance the safety by making the member on the distal end side, which is easy to manufacture the double balloon catheter (W1) and more flexible, to process each member.

[0027] [Second Embodiment]

Next, a second embodiment obtained by modifying the first embodiment of the present invention will be described. FIG. 3 is a schematic sectional view of the distal end side of a double balloon catheter (W2) according to a second embodiment of the present invention. The configuration of the double balloon catheter (W2) is almost the same as that of the first embodiment, but the boundary (15) where the cross-sectional area of each lumen changes is wider than that of the first embodiment (15 ) Running diagonally (making an acute angle with respect to the axis of the tube body (1)), the distal end side member and the proximal end side member are bonded or fused.

[0028] In the double vanolene catheter (W2) of the second embodiment, the distal end side member and the proximal end side member are bonded or fused together at the joining surface that forms an acute angle with the axis of the tube body (1). Therefore, the double balloon catheter (W2) is easy to manufacture, and when using materials with different flexibility for the distal and proximal members, the rigidity at the boundary is gradually changed to improve operability. Or safety can be further improved.

[0029] [Third embodiment]

Subsequently, a third embodiment obtained by modifying the first embodiment of the present invention will be described. FIG. 4 is an overall explanatory view of a double balloon catheter (W3) according to a third embodiment of the present invention, FIG. 5 (a) is a schematic cross-sectional view of the distal side of the double balloon catheter (W3), FIG. 5 (b), (c) is a cross-sectional view of C-Cf spring, DD.

[0030] The double balloon catheter (W3) has two ports (le, If) instead of the balloon port (lb). Further, in the double balloon catheter (W3), two lumens of a second A lumen (26) and a second B lumen (25) are provided instead of the second lumen (5) in the first embodiment. The second A lumen (26) communicates with the port (le) and the first side hole (8) with respect to the first balloon (2), and the second B lumen (25) includes the port (If) and the second balane ( It communicates with the second side hole (9) for 3). The second-A nomenclature (26) and the second-B lumen (25) are configured such that the cross-sectional area changes at the boundary and the front end side widens and the front end side narrows. [0031] In the double balloon catheter (W3) of the third embodiment, since there are two ports (le, If) for the balloon and two lumens or side holes corresponding to the two ports (le, If), each balloon Can be expanded and contracted individually, and the treatment site can be occluded even in a blood vessel whose cross-sectional area changes rapidly. The second A lumen (26) and the second B lumen (25) have a cross-sectional area that is wide at the proximal end and narrow at the distal end. Injection can be facilitated, and the outer diameter of the tube body (1) can be kept small and kept constant.

[0032] The embodiment of the present invention is not limited to the above-described embodiment, and the above-described embodiment can be variously modified as illustrated below. That is, the cross sectional areas of all of the second lumen, the second A lumen, the second B lumen, and the third lumen are not changed, but the cross sectional area is changed for a part of them. A plurality of side holes or perfusion holes and perfusion auxiliary holes are provided. Alternatively, change the location of each lumen as it appears in the A-A cross-sectional view etc. by replacing the position of the second lumen with the position of the third lumen. Do not reduce the outer diameter of the tube tip, or change it more slowly (more rapidly). Each lumen should also change more gently (more abruptly) at the boundary. The double balloon catheter is not composed of two separate members, but is a single unit or a larger number of members. The diameter of each lumen is the length or length of the tube body, and the diameter or length of each balloon is lengthened or shortened. The cross-sectional shape of each lumen shall be a polygonal shape other than a circle or a bowl shape. The outer cross-sectional shape of the tube is not circular but elliptical. Also, bend the tip of the tube body slightly (for example, 150 degrees or more and less than 180 degrees).

Brief Description of Drawings

[0033] FIG. 1 is an overall explanatory view of a double vanolene catheter according to a first embodiment of the present invention.

[FIG. 2] (a) is a schematic cross-sectional view of the distal end side of the double vanolene catheter of FIG. 1, and (b) and (c) are cross-sectional views taken along lines AA and BB.

FIG. 3 is a schematic cross-sectional view of the distal end side of a double vanolene catheter according to a second embodiment of the present invention.

FIG. 4 is an overall explanatory view of a double vanolene catheter according to a third embodiment of the present invention. 5 (a) is a schematic cross-sectional view of the distal side of the double balloon catheter of FIG. 4, and (b) and (c) are CC line and DD cross-sectional views.

Explanation of symbols

1 Tube body

2 First balloon

3 Second balloon

4 First Nomenen

5 Second lumen

7 3rd lumen

8 1st side hole

9 Second side hole

10 3rd side hole

11 Perfusion assist hole

12 Perfusion hole

Claims

The scope of the claims

A tube body;

A first lumen that is formed in the tube body and opens to the tip of the tube body and through which the guide wire can pass;

A first side hole and a second side hole formed at regular intervals on the outer peripheral wall of the distal end edge of the tube body;

A second lumen formed in the tube body and communicating with the first side hole and the second side hole;

A first balloon and a second balloon installed around an outer periphery of the tube main body so as to cover each of the first side hole and the second side hole;

A third side hole formed in the outer peripheral wall of the tube main body between the first balloon and the second vanolene;

A third lumen that is formed in the tube body and communicates with the third side hole, and a perfusion that is formed on the outer peripheral wall of the tube body on the proximal side of the second balloon and communicates with the first lumen. With holes,

The cross-sectional area of the first lumen and the cross-sectional area of at least one of the second lumen and the third lumen are at the boundary disposed on the proximal side from the perfusion hole, and the distal end side and the proximal end of the tube main body are Change with the side,

The first lumen has a larger sectional area on the distal end side than on the proximal end side.

At least one of the second lumen and the third lumen is configured such that the cross-sectional area on the distal end side is smaller than the proximal end side.

A double balloon catheter characterized by that.

Instead of the second lumen, there are provided a second A lumen and a second B lumen respectively formed in the tube body,

The second A lumen communicates only with the first side hole, the second B lumen communicates only with the second side hole,

A cross-sectional area of the first lumen, and at least one of the second A lumen, the second B lumen, or the third lumen at a boundary disposed on the proximal side from the perfusion hole. The area changes between the distal end side and the proximal end side of the tube body,

The first lumen has a larger cross-sectional area on the distal end side than on the proximal end side

At least one of the second A lumen, the second B lumen, or the third lumen is configured so that the cross-sectional area on the distal end side is smaller than the proximal end side.

The double balloon catheter according to claim 1, wherein:

[3] A perfusion assisting hole formed on the outer peripheral wall of the tube body on the distal end side from the first balloon and communicating with the first lumen.

The double balloon catheter according to claim 1 or 2, wherein

[4] At the boundary, the cross-sectional area of at least one lumen gradually changes

The double balloon catheter according to any one of claims 1 to 3, wherein the double balloon catheter is characterized.

[5] The portion on the distal end side and the portion on the proximal end side from the boundary are formed of separate members,

These members are bonded or fused together

5. The double balloon catheter according to any one of claims 1 to 4.

[6] The distal end portion and the proximal end portion are bonded to each other at a bonding surface that forms an acute angle with respect to the axis of the tube body, and are bonded or fused together.

6. The double balloon catheter according to claim 5, wherein