JP7432333B2 - balloon catheter - Google Patents

Description

TECHNICAL FIELD The present invention relates to balloon catheters.

For example, Patent Document 1 discloses a balloon catheter for treating a diseased part (stenosis or occlusion) of a fallopian tube. This balloon catheter includes a flexible outer tube, an inner tube disposed in the inner lumen of the outer tube so as to be movable in the axial direction relative to the outer tube, and a distal end of the outer tube and an inner tube. and an annular balloon that connects the distal end portions to each other and expands inward in the radial direction of the outer tube.

Patent No. 3921108

In salpingoscopic salpingoplasty using a balloon catheter, a balloon is inflated inward in the radial direction of the outer tube and guided to the distal end of the outer tube to push against the diseased part (occlusion or stenosis) of the fallopian tube. Perform the expanding balloon derivation process.

Specifically, in the balloon extraction step, the balloon and the salpingoscope are advanced relative to the external tube in a state in which the balloon is inflated and brought into close contact with (supported by) the salpingoscope. At this time, since the balloon protrudes distally from the distal opening of the outer tube while its distal end is turned over, the forward distance of the balloon is half of the forward distance of the salpingoscope. Therefore, when the tip of the salpingoscope reaches the tip of the balloon, it is necessary to reduce the pressure of the fluid used to inflate the balloon and retreat the salpingoscope with respect to the balloon.

In this way, with conventional balloon catheters, the balloon is pressed against the salpingoscope (medical wire material), which tends to damage the salpingoscope, and the salpingoscope must be retracted relative to the balloon, so the balloon There is a possibility that the derivation process cannot be performed efficiently.

The present invention was made in consideration of such problems, and an object of the present invention is to provide a balloon catheter that can reduce damage to medical wires and efficiently carry out the balloon extraction process. do.

One aspect of the present invention provides a flexible outer tube, an inner tube disposed in a lumen of the outer tube so as to be movable in the axial direction with respect to the outer tube, and a distal end of the outer tube. a balloon mechanism having an annular balloon that connects the inner tube and the distal end of the inner tube and inflates inward in the radial direction of the outer tube, the balloon mechanism having a With the balloon inflated radially inward without inserting a medical wire, a pushing force in the distal direction is transmitted from the inner tube to the balloon, causing the balloon to open at the distal end of the outer tube. The balloon is formed so as to be able to protrude in the distal direction from the balloon, and as the balloon protrudes, it is possible to spread out a lesion that is a blocked or constricted part of the biological duct by the balloon into which the medical wire is not inserted. An outer space is formed between the balloon and the outer tube to which a balloon operating fluid for inflating the balloon radially inward is supplied, and the balloon mechanism is arranged in the outer space. The balloon catheter has a deflection suppressing member disposed in the balloon for suppressing deflection of the balloon .

According to the present invention, it is possible to spread the lesion area using a balloon into which no medical wire is inserted, so that damage to the medical wire can be reduced. In addition, since the retraction process of retracting the medical wire relative to the balloon is not necessary, the balloon extraction process can be performed efficiently.

1 is a schematic configuration diagram of a balloon catheter according to an embodiment of the present invention. 2 is a partially omitted vertical cross-sectional view of the balloon catheter of FIG. 1. FIG. FIG. 2 is a first explanatory view of salpingoscopic salpingoplasty using the balloon catheter of FIG. 1; FIG. 2 is a second explanatory view of salpingoscopic salpingoplasty using the balloon catheter of FIG. 1; FIG. 2 is a third explanatory diagram of salpingoscopic salpingoplasty using the balloon catheter of FIG. 1; FIG. 4 is a fourth explanatory view of salpingoscopic salpingoplasty using the balloon catheter of FIG. 1; It is a partially omitted vertical cross-sectional view of a balloon catheter equipped with a deflection suppressing member according to a modification.

Hereinafter, preferred embodiments of the balloon catheter according to the present invention will be described with reference to the accompanying drawings.

The balloon catheter 10 according to an embodiment of the present invention is used, for example, in salpingoscopic salpingoplasty to treat a diseased part (stenosis, obstruction, etc.) of a fallopian tube. However, the balloon catheter 10 may be used to treat lesions in living organs other than the fallopian tubes, such as blood vessels, bile ducts, tracheas, esophagus, urethra, and other organs.

1 and 2, the balloon catheter 10 includes an outer catheter 16, a slider 18 provided on the outer catheter 16, an inner catheter 20 inserted into the outer catheter 16, and a balloon catheter 10 provided at the distal end of the inner catheter 20. and a balloon mechanism 23 having a balloon 22.

The outer catheter 16 includes an elongated flexible outer tube 24, an outer tube hub 26 provided at the proximal end of the outer tube 24, and a fixing screw 28 provided on the outer tube hub 26. The total length of the outer tube 24 is preferably set to 100 mm or more and 1500 mm or less, more preferably 200 mm or more and 1000 mm or less.

In FIG. 2, the outer tube 24 includes an outer tube main body 30 and a distal tip 32 provided at the distal end of the outer tube main body 30. The constituent materials of the outer tube body 30 and the tip 32 include, for example, polyolefin (for example, polyethylene, polypropylene, polybutene, etc.), olefin elastomer, polyester (for example, polyethylene terephthalate, etc.), polyester elastomer, and soft polychloride. Examples include flexible polymeric materials such as vinyl, polyurethane, urethane elastomer, polyamide, amide elastomer, polytetrafluoroethylene, fluororesin elastomer, polyimide, ethylene-vinyl acetate copolymer, and silicone rubber.

The outer tube main body 30 is a tube body having a first lumen 30a penetrating from the distal end to the proximal end. The outer tube main body 30 has a substantially constant outer diameter from the distal end to the proximal end. The outer diameter of the outer tube 24 is preferably set to 1.8 mm or more and 10 mm or less, more preferably 2.3 mm or more and 8 mm or less. The distal end side of the outer tube main body 30 is shaped to be curved in an arc shape.

The outer surface of the distal tip 32 is curved to prevent damage to the balloon catheter 10 and living tissue. A balloon outlet hole 32a is formed in the distal tip 32 to allow the balloon 22 to be guided out in the distal direction from the distal tip 32.

The outer tube hub 26 is made of hard resin or metal (stainless steel, titanium, titanium alloy, etc.). Examples of the hard resin include polycarbonate, acrylic resin, polyester, polyolefin, styrene resin, polyamide, polysulfone, polyarylate, and polyetherimide.

The outer tube hub 26 is hollow and has a size that is easy to operate manually. The outer tube hub 26 includes a first space 34 that communicates with the first lumen 30a of the outer tube 24, and a first insertion hole 36 located on the proximal end side of the first space 34 and into which the inner catheter 20 is inserted. An introduction port 38 communicating with the first space 34 is formed.

The introduction port 38 introduces a balloon operating fluid supplied from a syringe or the like (not shown) into the first space 34 . The balloon operating fluid is a fluid for inflating the balloon 22 inward in the radial direction of the outer tube 24, and is, for example, physiological saline. The outer tube hub 26 is provided with a first seal member 42 that prevents the fluid in the first space 34 from leaking to the outside through the first insertion hole 36 .

The fixing screw 28 fixes the inner catheter 20 to the outer tube hub 26 by screwing into a screw hole 44 formed at the proximal end of the outer tube hub 26 . The fixing screw 28 may be made of the same material as the outer tube hub 26.

The slider 18 is provided on the outer peripheral surface of the outer tube 24 so as to be movable (slidable) in the axial direction of the outer tube 24. The total length of the slider 18 is shorter than the total length of the outer tube 24. The slider 18 includes a long tubular slider body 46 and a slider hub 48 provided at the base end of the slider body 46. Each of the slider body 46 and the slider hub 48 is made of the same material as the outer tube hub 26 described above.

The slider hub 48 is formed into an annular shape with a size that is easy to operate manually.

When the slider 18 is moved to the most proximal side with respect to the outer tube 24 (the proximal end of the slider 18 is positioned at the distal end of the outer tube hub 26), the distal end side of the outer tube 24 is further away from the slider 18. It is also exposed on the tip side and curved in an arc shape. When the slider 18 is moved to the distal end side with respect to the outer tube 24, the distal end side of the outer tube 24 extends linearly along the shape of the slider body 46.

The inner catheter 20 includes an elongated inner tube 50 and an inner tube hub 52 provided at the proximal end of the inner tube 50. The total length of the inner tube 50 is preferably set to 100 mm or more and 1500 mm or less, more preferably 200 mm or more and 1000 mm or less.

The inner tube 50 is made of relatively hard resin (for example, fluororesin, polycarbonate, polyimide, PEEK resin, etc.) or metal (for example, stainless steel, titanium, titanium alloy, etc.). The inner tube 50 is a tube body having a second lumen 50a penetrating from the distal end to the proximal end. The inner tube 50 has a substantially constant inner diameter and a substantially constant outer diameter from the distal end to the proximal end. The outer diameter of the inner tube 50 is preferably set to 0.8 mm or more and 6.8 mm or less, more preferably 1 mm or more and 5 mm or less. The wall thickness of the inner tube 50 is preferably set to 0.025 mm or more and 1 mm or less, more preferably 0.03 mm or more and 0.5 mm or less.

The inner tube 50 is inserted through the first space 34 and the first insertion hole 36 of the outer tube hub 26 and is disposed in the first inner cavity 30a of the outer tube 24. The distal end of the inner tube 50 is located closer to the proximal end than the distal end of the outer tube 24. An outer lumen 54 is provided between the inner tube 50 and the outer tube 24, through which a balloon operating fluid flows.

A salpingoscope 15 as a medical wire is inserted into the second lumen 50a of the inner tube 50. The salpingoscope 15 is an endoscope for photographing the inside of the fallopian tube. When the salpingoscope 15 is inserted into the second lumen 50a of the inner tube 50, an inner lumen 56 (perfusion lumen) through which irrigation fluid flows is provided between the inner tube 50 and the salpingoscope 15. It is formed. The perfusion fluid is, for example, physiological saline.

The inner tube hub 52 is made of the same material as the outer tube hub 26. The inner tube hub 52 is formed in a hollow shape. The inner tube hub 52 includes a second space 58 that communicates with the second lumen 50a of the inner tube 50, and a second insertion hole 60 located on the proximal side of the second space 58 and into which the salpingoscope 15 is inserted. , and an introduction port 62 communicating with the second space 58 are formed.

The introduction port 62 introduces perfusion fluid supplied from an unillustrated perfusion pump or the like into the second space 58 . The inner tube hub 52 is provided with a second seal member 66 that prevents the fluid in the second space 58 from leaking to the outside through the second insertion hole 60.

The balloon mechanism 23 includes a balloon 22 and a deflection suppressing member 70. The balloon mechanism 23 allows pushing force in the distal direction to be transmitted from the inner tube 50 to the balloon 22 while the balloon 22 is inflated radially inward without inserting the salpingoscope 15 inside the balloon 22. The balloon 22 is formed to be able to protrude distally from the distal opening 24a of the outer tube 24, and as the balloon 22 protrudes, the salpingoscope 15 is inserted into the diseased part (stenosis or obstruction) of the fallopian tube. It is formed so that it can be expanded by the balloon 22 that is not inflated.

The balloon 22 is an annular member that connects the distal end of the outer tube 24 and the distal end of the inner tube 50 to each other. The balloon 22 inflates inward in the radial direction of the outer tube 24. In other words, the balloon 22 is formed to be elastically deformable in the radial direction.

The balloon 22 is configured so that the balloon 22 into which the salpingoscope 15 is not inserted can expand a diseased area such as an occluded area or a stenotic area of the fallopian tube. The thickness of the balloon 22 is preferably set to, for example, 0.01 mm or more and 0.1 mm or less. The Shore D hardness of the balloon 22 is 40 or more.

Examples of the constituent materials of the balloon 22 include natural rubber, polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, soft polyvinyl chloride, polyurethane, polyurethane elastomer, polyisoprene, polyamide, polyamide elastomer, Examples include polyimide, polytetrafluoroethylene, and silicone rubber. The balloon 22 is preferably made of polyamide elastomer, urethane elastomer, or polyester elastomer.

One end of the balloon 22 is adhered or fused to the distal end of the outer tube 24. In other words, one end of the balloon 22 is adhered or fused to the outer tube 24 near the proximal end of the balloon outlet hole 32a. The other end of the balloon 22 is adhered or fused to the tip of the outer surface of the inner tube 50. However, the other end of the balloon 22 may be adhered or fused to the tip of the inner surface of the inner tube 50.

The balloon 22 is pushed out toward the distal end of the outer tube 24 through the balloon outlet hole 32a as the inner tube 50 moves toward the distal end relative to the outer tube 24 (see FIGS. 5 and 6). The balloon 22 is formed such that the inner surface of the balloon 22 has a color different from the inner surface of the fallopian tube (for example, yellow-green). Thereby, it is possible to easily determine whether the tip of the salpingoscope 15 is located within the balloon 22 or not.

A bag-shaped outer space S with a closed tip is formed between the balloon 22 and the outer tube 24. The inside of the balloon 22 opens toward the distal end.

As shown in FIG. 2, the deflection suppressing member 70 is disposed in the outer space S. As shown in FIG. The deflection suppressing member 70 is a coil member 72. Examples of the constituent material of the coil member 72 include metal materials, resin materials, and the like.

The coil member 72 is provided such that the balloon 22 is located inside the coil member 72. The total length (free length) of the coil member 72 is approximately the same as the total length of the balloon 22. In other words, the coil member 72 covers substantially the entire length of the balloon 22 in the initial state of the balloon catheter 10 in which the inner tube 50 is retracted the most with respect to the outer tube 24 . However, the total length (free length) of the coil member 72 may be shorter than the total length of the balloon 22. That is, the coil member 72 may cover only the distal end side of the balloon 22 in the initial state of the balloon catheter 10.

The inner diameter of the coil member 72 is approximately the same as the outer diameter of the balloon 22 when the balloon 22 is not inflated (the balloon 22 is not elastically deformed radially inward). That is, the inner surface of the coil member 72 is in contact with the outer surface of the balloon 22. The coil member 72 is formed so that adjacent windings 72a are spaced apart from each other when the outer tube 24 is not bent. The pitch of the coil member 72 (the interval between adjacent windings 72a) can be set as appropriate. The cross-sectional shape of the winding 72a is circular. However, the cross-sectional shape of the winding wire 72a is not limited to a circular shape, but may be a rectangular shape or the like. Note that the coil member 72 may be in contact with the inner circumferential surface of the outer tube main body 30.

Next, salpingoscopic salpingoplasty using the balloon catheter 10 configured as described above will be described.

In salpingoscopic salpingoplasty, as shown in FIG. Bring it close to the fallopian tube orifice 202a (insertion step). At this time, the operator confirms the oviduct orifice 202a using the image of the oviductoscope 15.

Subsequently, a balloon ejection step is performed in which the balloon 22 inflated inward in the radial direction of the outer tube 24 is guided out to the distal end side of the outer tube 24 to spread the lesioned part 204 of the fallopian tube 202. Specifically, in FIG. 4, the balloon operating fluid is supplied to the introduction port 38 with the salpingoscope 15 pulled out from the balloon 22 (pressurization step). Then, the balloon operating fluid is supplied from the introduction port 38 to the outer space S of the balloon 22 via the first space 34 and the outer lumen 54. The balloon 22 is pressed radially inward by the balloon operating fluid supplied to the outer space S and is elastically deformed. That is, the inner surfaces of the balloons 22 are in contact with each other.

Thereafter, as shown in FIG. 5, the operator operates the inner tube hub 52 with the fixing screw 28 loosened to advance the inner tube 50 relative to the outer tube 24 (advance step). Then, the balloon 22 pushed toward the distal end by the inner tube 50 is led out toward the distal end of the outer tube 24 via the balloon outlet hole 32a.

At this time, since one end of the balloon 22 is fixed to the distal end of the outer tube 24, the balloon 22 moves forward while its distal end is turned over. That is, the balloon 22 is turned over at its tip so that the inner surface faces outward. Therefore, the balloon 22 moves forward by a distance equivalent to half of the forward movement distance of the salpingoscope 15.

Then, as shown in FIG. 6, when the balloon 22 reaches the lesion 204, the balloon 22 pushes and spreads the lesion 204. That is, the narrowing or occlusion of the fallopian tube 202 is improved. At this time, the balloon 22 receives a reaction force from the lesion 204. However, since the balloon 22 is relatively hard, it is difficult to bend due to reaction force. Further, the deflection of the balloon 22 is suppressed by the coil member 72.

After expanding the lesion 204, the operator removes the balloon catheter 10 (removal step). Note that before removing the balloon catheter 10, inject physiological saline through the introduction port 62, insert the salpingoscope 15, and remove the balloon catheter 10 while observing the inside of the fallopian tube 202 with the salpingoscope 15. You may. This completes the salpingoscopic salpingoplasty.

In this case, the balloon catheter 10 according to this embodiment has the following effects.

In the balloon catheter 10, the balloon mechanism 23 applies a pushing force in the distal direction from the inner tube 50 to the balloon 22 in a state in which the balloon 22 is inflated radially inward without inserting the salpingoscope 15 inside the balloon 22. This transmission allows the balloon 22 to protrude distally from the distal opening 24a of the outer tube 24, and as the balloon 22 protrudes, the salpingoscope 15 inserts the diseased part 204 of the fallopian tube 202. It is formed so that it can be expanded by the balloon 22 that is not inflated.

According to such a configuration, the lesioned area 204 can be spread apart by the balloon 22 into which the salpingoscope 15 is not inserted, so that damage to the salpingoscope 15 can be reduced. Further, since the retraction step of retracting the salpingoscope 15 with respect to the balloon 22 is not necessary, the balloon extraction step can be performed efficiently.

The Shore D hardness of the balloon 22 is 40 or more.

According to such a configuration, the diseased part 204 of the fallopian tube 202 can be effectively expanded using only the balloon 22.

An outer space S is formed between the balloon 22 and the outer tube 24 to which a balloon operating fluid for inflating the balloon 22 radially inward is supplied, and the balloon mechanism 23 is disposed in the outer space S. It has a deflection suppressing member 70 for suppressing deflection of the balloon 22.

According to such a configuration, the deflection suppressing member 70 can suppress the balloon 22 from deflecting due to a reaction force when the balloon 22 spreads the lesion 204.

The deflection suppressing member 70 is a coil member 72.

According to such a configuration, the configuration of the deflection suppressing member 70 can be simplified.

The inner diameter of the coil member 72 is approximately the same as the outer diameter of the balloon 22 when the balloon 22 is not inflated.

According to such a configuration, the deflection of the balloon 22 can be efficiently suppressed by the coil member 72.

As shown in FIG. 7, in the balloon catheter 10, the deflection suppressing member 70 may be a flexible cylindrical body 74 instead of the coil member 72. The cylinder body 74 is formed into a cylindrical shape. The outer peripheral surface of the cylindrical body 74 is in contact with the inner peripheral surface of the outer tube main body 30. The inner peripheral surface of the cylinder 74 is in contact with the outer peripheral surface of the balloon 22 when the balloon 22 is not inflated. However, the inner circumferential surface of the cylindrical body 74 may be spaced apart from the outer circumferential surface of the balloon 22 while the balloon 22 is not inflated. A hole 74 a is formed in the wall of the cylindrical body 74 for guiding the balloon operating fluid to the balloon 22 . That is, the cylinder 74 is a porous member.

The cylindrical body 74 is formed into a mesh shape or a sponge shape. Specifically, the mesh-like cylinder 74 can be formed by, for example, weaving metal or resin wire. Further, the sponge-like cylindrical body 74 can be formed by foam molding a resin material.

In this modification, the deflection suppressing member 70 is a flexible cylindrical body 74.

According to such a configuration, deflection of the balloon 22 can be effectively suppressed by the cylinder body 74.

The cylindrical body 74 is formed into a mesh shape or a sponge shape.

According to such a configuration, the balloon operating fluid can be efficiently supplied to the entire outer space S.

In the balloon catheter 10, the deflection suppressing member 70 may be omitted. Even in such a case, since the balloon 22 is formed to be relatively hard, the lesioned area 204 can be expanded using only the balloon 22 without using the salpingoscope 15.

The present invention is not limited to the embodiments described above, and various modifications can be made without departing from the gist of the present invention.

The above embodiments can be summarized as follows.

The above embodiment includes a flexible outer tube (24) and an inner tube (50) disposed in the inner lumen (30a) of the outer tube so as to be movable in the axial direction with respect to the outer tube. and a balloon mechanism (23) having an annular balloon (22) that connects the distal end of the outer tube and the distal end of the inner tube and inflates inward in the radial direction of the outer tube. 10), wherein the balloon mechanism is such that when the balloon is inflated radially inward without inserting the medical wire (15) inside the balloon, a pushing force in the distal direction is applied from the inner tube. By being transmitted to the balloon, the balloon is formed to be able to protrude in the distal direction from the distal opening (24a) of the outer tube, and as the balloon protrudes, the occluded portion of the biological tube (202) or A balloon catheter is disclosed that is formed so that a diseased part (204), which is a stenotic part, can be pushed and expanded by the balloon in which the medical wire is not inserted.

In the balloon catheter described above, the balloon may have a Shore D hardness of 40 or more.

In the above balloon catheter, an outer space (S) is formed between the balloon and the outer tube, and an outer space (S) is supplied with a balloon operating fluid for inflating the balloon radially inward, and the balloon mechanism may include a deflection suppressing member (70) disposed in the outer space to suppress deflection of the balloon.

In the above balloon catheter, the deflection suppressing member may be a coil member (72).

In the balloon catheter described above, the inner diameter of the coil member may be substantially the same as the outer diameter of the balloon in an uninflated state.

In the above balloon catheter, the deflection suppressing member may be a flexible cylinder (74).

In the above balloon catheter, the cylindrical body may be formed in a mesh shape or a sponge shape.

10...Balloon catheter 15...Salpingoscope (medical wire)
22... Balloon 24... Outer tube 30a... First inner cavity (lumen) 50... Inner tube 70... Deflection suppressing member 72... Coil member 74... Cylindrical body S... Outer space

Claims (5)

an outer tube having flexibility; an inner tube disposed in a lumen of the outer tube so as to be movable in the axial direction relative to the outer tube; a distal end of the outer tube; and a distal end of the inner tube. a balloon mechanism having an annular balloon connecting the outer tube and the outer tube and inflating inward in the radial direction of the outer tube,
In the balloon mechanism, a pushing force in the distal direction is transmitted from the inner tube to the balloon while the balloon is inflated radially inward without inserting a medical wire inside the balloon. The balloon is formed to be able to protrude in the distal direction from the distal opening of the outer tube, and the medical wire is inserted into a lesion that is a blocked or constricted portion of the biological tube as the balloon protrudes. formed so as to be inflatable by said balloon;
An outer space is formed between the balloon and the outer tube, into which a balloon operating fluid for inflating the balloon radially inward is supplied;
The balloon mechanism is a balloon catheter, wherein the balloon mechanism has a deflection suppressing member disposed in the outer space to suppress deflection of the balloon. The balloon catheter according to claim 1 ,
In the balloon catheter, the deflection suppressing member is a coil member. The balloon catheter according to claim 2 ,
In the balloon catheter, an inner diameter of the coil member is approximately the same as an outer diameter of the balloon when the balloon is not inflated. The balloon catheter according to claim 1 ,
In the balloon catheter, the deflection suppressing member is a flexible cylindrical body. The balloon catheter according to claim 4 ,
A balloon catheter in which the cylindrical body is formed into a mesh shape or a sponge shape.

Images