JP4586545B2 - Balloon catheter - Google Patents

Description

  The present invention relates to a balloon catheter used in the treatment of congenital heart diseases such as tricuspid valve closure, pure pulmonary artery closure, and complete macrovascular transition. In particular, the present invention relates to a balloon catheter used for atrial septal opening.

    One of the treatments for congenital heart diseases such as tricuspid valve closure, pure pulmonary artery closure, and complete macrovascular transition is formation of interatrial traffic. Inter-atrial traffic is a puncture of the atrial septum between the right and left atria that causes blood flow between the atria. Inter-atrial traffic improves hypoxemia and pulmonary congestion.

  Conventionally, a balloon catheter has been used as an atrial septal opening, but there is a problem that adaptation is limited because the catheter is too thick for newborns and infants. In actual use, the sheath (sheath introducer) used when inserting the catheter into the blood vessel is thick, and there is a problem that the mental and physical burden on the patient is large.

As a catheter related to the atrial septum, for example, a catheter as disclosed in Patent Document 1 is known.

Special table 2003-509175 gazette

  In order to reduce the diameter of a conventional catheter with respect to the conventional problems as described above, it is necessary to make the balloon thin. However, various problems such as insufficient balloon expansion diameter and reduced balloon strength (distortion and rupture due to pulling) occur.

  The present invention has been made in view of the above circumstances, and can reliably tear the atrial septum, causing problems such as insufficient balloon expansion diameter and reduced balloon strength (distortion and rupture due to tension). It is an object of the present invention to provide a catheter for atrial septal opening that can be used for a thinner sheath.

In order to solve the above-mentioned problems, the present inventors, as a result of intensive studies, a balloon-like balloon is attached to the tip of the shaft, and if a fixing member is attached to the end of the balloon, The inventors have conceived that the diameter of the catheter can be reduced and that the corresponding sheath size can also be reduced, thereby completing the present invention. That is, the balloon catheter includes a balloon that can be expanded and contracted and a shaft to which the balloon is attached at the tip, and a fixing member is provided at the attachment portion of the balloon that is attached to the shaft. Further, the fixing member is a pair of members facing both ends of the balloon. Moreover, a pair of member is the same shape.

In addition, the fixing member has a wide-mouthed shape in which a portion in contact with the balloon extends toward the balloon. Furthermore, the fixing member has a rotating body shape and is provided so that the axis is aligned with the axis of the shaft, and has a tapered shape that extends toward the balloon on the outer peripheral surface. Furthermore, the outer diameter of the fixing member is 0.6 to 2.5 mm. Furthermore, the material for forming the fixing member is a soft material. Furthermore, the forming material of the fixing member is a metal material. In addition, the material for forming the fixing member is a composite material in which a soft material and a metal material are combined. In addition, the composite material is a blade tube.

  By adopting the present invention, there are no problems such as insufficient balloon expansion diameter and reduced balloon strength (distortion and rupture due to pulling), and a thinner sheath can be used in catheterization. The mental and physical burden on the patient can be reduced, and the atrial septal opening can be easily performed.

  In addition, since the part where the fixing member and the balloon come into contact has a wide-mouth shape that expands toward the balloon, the balloon when expanded can be held stably and reliably by the large and large contact part, and the position of the balloon can be displaced. It is possible to suppress. Furthermore, since the fixing member has a tapered shape that spreads toward the balloon on the outer peripheral surface, not only smooth insertion and extraction into the sheath but also contact with surrounding tissues when moving in the body. The situation of damaging the organization can be prevented.

  Soft materials such as plastics and natural rubber, metal materials such as stainless steel, and composite materials such as braided tubes can be used. Therefore, flexibility and strength can be increased, and flexibility and strength can be freely adjusted.

Next, embodiments of the present invention will be described with reference to the drawings.
FIG. 1 is a plan view showing an embodiment of the present invention. FIG. 2 is a plan view showing another embodiment of the present invention.

FIG. 3 is an enlarged view of the distal end portion including the balloon and the fixing member in FIG. FIG. 4 is an enlarged cross-sectional view taken along line AA in FIG. FIG. 5 is a view showing a state in which the balloon is expanded in FIG. 3. 6 to 9 are explanatory views of the atrial septal opening using the atrial septal opening catheter of the present invention. FIG. 10 is a diagram showing dimensions of the both-end fixed portion of the balloon by the fixing member.

  As shown in FIGS. 1 to 5, the catheter for atrial septal opening of the present invention includes a shaft 2, a balloon-like balloon 1 attached to the tip of the shaft 2, and a balloon 1 when the balloon 1 is expanded. , A fixing member 3 that can be smoothly inserted into and removed from the sheath, and a connector 4 and a two-way stopcock 5 attached to the proximal end of the shaft 2. Consists of.

  The shaft 2 can be inserted into the blood vessel from the femoral vein via a sheath (not shown), and has a hardness that does not cause damage in the blood vessel. The shaft 2 has a perfect circle shape or a shape close thereto, and the size is desirably an outer diameter of 0.5 to 2 mm. The shaft 2 is provided with a lumen (not shown) for sending physiological saline for expanding the balloon 1, and the number of lumens is determined as necessary. The shaft 2 may be a double lumen or a double tube provided with a guide wire lumen (not shown). As a material for forming the shaft 2, plastics such as polyolefin, polyamide, polyester, fluororesin, silicone resin, polyvinyl chloride, and polyurethane, natural rubber, stainless steel, a braided tube combining plastic and stainless steel, and the like can be used.

  The balloon 1 can be expanded to such a size that the atrial septum can be cleaved, and since the expansion diameter necessary for the cleaving is 30 mm at the maximum, the outer diameter is preferably 2 to 5 mm. The elongation is preferably about 5 to 8 times. As a material for forming such a balloon 1, synthetic rubber such as silicone rubber or polyisoprene, natural rubber, or the like can be used. The thickness of the balloon 1 is generally about 0.1 to 0.5 mm, preferably about 0.2 mm.

  The balloon 1 can be attached to the shaft 2 by adhering both ends of the balloon 1 using, for example, a cyanoacrylate or silicone adhesive.

  The fixing member 3 suppresses displacement of the balloon 1 when the balloon 1 is expanded (distortion when the balloon 1 is pulled), and enables smooth insertion and removal from the sheath. It arrange | positions in the attachment part with the shaft 2. FIG. The length of each fixing member 3 in the axial direction is about 3 to 20 mm, preferably about 5 to 10 mm. Each fixing member 3 covers and fixes both end portions of the balloon 1. The total length of both end portions of the balloon 1 covered with each fixing member 3 is about 5 to 50% of the total length of the balloon 1. The length of the balloon 1 that is not covered with each fixing member 3 is 3 to 30 mm, and preferably 10 to 20 mm. (See Figure 10)

Next, the fixing member 3 will be described in detail. The fixing member 3 is a pair of members facing both ends of the balloon 1. Since the fixing member 3 is disposed so as to face both ends of the balloon 1, the positional deviation of the balloon 1 when the balloon 1 is expanded can be reliably suppressed. Further, since the pair of fixing members 3 have the same shape, the parts can be shared (standardized) in the product, and the cost can be reduced. Furthermore, the fixing member 3 has a wide-mouthed shape 31 in which the portion that contacts the balloon 1 extends toward the balloon. Therefore, it is possible to stably hold the large contact portion balloon 1 stably and surely when the balloon 1 is expanded, and to suppress the displacement of the balloon 1.

In addition, the fixing member 3 has a rotating body shape (shaft object shape) and is provided so that the shaft center is aligned with the shaft center of the shaft 2, and has a tapered shape 32 spreading toward the balloon 1 on the outer peripheral surface. Yes. Therefore, not only smooth insertion and removal from the sheath, but also the fixing member 3 does not pierce the surrounding tissue when moving in the body, and even if the fixing member 3 contacts the surrounding tissue, the tissue is damaged. Such a situation can be prevented. It is possible to arrange only one fixing member 3 at one end. In addition, the fixing member 3 may have a taper shape 32 of the fixing member 3 on the distal end side slightly longer than the other in order to make the insertion into the body more smooth, and may not have the same shape.

The size of the fixing member 3 is preferably 0.6 to 2.5 mm in outer diameter in order to match the dimension of the shaft 2 and the applicable sheath size. As a material for forming the fixing member 3, soft materials such as polyolefins, polyamides, polyesters, fluororesins, silicone resins, plastics such as polyvinyl chloride and polyurethane, and natural rubber can be employed. The use of a soft material can be expected to reduce the weight and flexibility of the fixing member.

Furthermore, a metal material with good corrosion resistance such as stainless steel can be used. By using a metal material, the strength of the fixing member can be increased. In addition, it is also possible to employ a composite material, such as a braid tube, in which a plastic material, which is a soft material, is embedded with a metal material such as a stainless steel fiber that is configured in a mesh shape, and the soft material and the metal material are combined. By adopting the composite material, the balance between flexibility and strength of the fixing member can be improved.

  The fixing member 3 can be attached by, for example, adhesion using a cyanoacrylate-based or silicone-based adhesive, heat welding, or fixing with a heat-shrinkable tube.

  In addition, the catheter may be bent at 30 to 40 degrees in accordance with the position of the atrial septum as shown in FIG.

  Next, atrial septal opening using the catheter for atrial septal opening of the present invention will be described with reference to the drawings (FIGS. 6 to 9).

  First, a catheter for atrial septal dehiscence as shown in FIG. 1 is prepared, inserted through the femoral vein with the balloon 1 in a sufficiently negative pressure, passed through a microaperture in the atrial septum, and left in the left atrium. The tip of the shaft 2 including the balloon 1 is introduced (see FIG. 6). After confirming the position, the balloon 1 is expanded by injecting, for example, physiological saline containing a contrast medium into the balloon 1 through a lumen (not shown) (FIG. 7). After the balloon 1 is expanded to the target size, the catheter is pulled, and the balloon 1 is pulled out so as to expand the micropores in the atrial septum (FIG. 8). When the balloon 1 is pulled out to the right atrium, and the formation of a sufficiently large hole is confirmed, the physiological saline containing the contrast medium is withdrawn from the balloon 1, and the balloon 1 is set to a sufficiently negative pressure as in the insertion. (FIG. 9). Finally, the atrial septal dehiscence catheter is removed from the body and the atrial septal dehiscence is completed.

It is a top view which shows one Example of this invention. It is a top view which shows the other Example of this invention. It is an enlarged view of the front-end | tip part containing the balloon and fixing member in FIG. It is an AA line expanded sectional view of FIG. It is a figure which shows the state which expanded the balloon in FIG. It is explanatory drawing of the atrial septal opening using the catheter for atrial septal opening of this invention. It is explanatory drawing of the atrial septal opening using the catheter for atrial septal opening of this invention. It is explanatory drawing of the atrial septal opening using the catheter for atrial septal opening of this invention. It is explanatory drawing of the atrial septal opening using the catheter for atrial septal opening of this invention. It is a figure which shows the dimension of the both ends fixed part of the balloon by a fixing member.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Balloon 2 Shaft 3 Fixing member 31 Wide mouth shape 32 Taper shape

Claims (8)

A balloon that can expand and contract,
A shaft wherein the balloon is attached to the tip portion,
Provided at least one fixed member is fixed over the mounting portion between both ends of the shaft of the balloon,
The fixing member is a pair of members facing both ends of the balloon,
The fixing member is a balloon catheter having a wide mouth shape that extends toward a balloon expandable portion . The balloon catheter according to claim 1, wherein the pair of members have the same shape. The balloon catheter according to claim 1 or 2, wherein the fixing member has a rotating body shape and is provided so that the axis is aligned with the axis of the shaft, and has a tapered shape that extends toward the balloon on the outer peripheral surface. The balloon catheter according to claim 3, wherein an outer diameter of the fixing member is 0.6 to 2.5 mm. The balloon catheter according to any one of claims 1 to 4, wherein a material for forming the fixing member is a soft material. The balloon catheter according to any one of claims 1 to 5, wherein a forming material of the fixing member is a metal material. The balloon catheter according to any one of claims 1 to 6, wherein a material for forming the fixing member is a composite material in which a soft material and a metal material are combined. The balloon catheter according to claim 7, wherein the composite material is a blade tube.

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