WO2021059935A1

WO2021059935A1 - Catheter

Info

Publication number: WO2021059935A1
Application number: PCT/JP2020/033717
Authority: WO
Inventors: 早川浩一
Original assignee: テルモ株式会社
Priority date: 2019-09-26
Filing date: 2020-09-07
Publication date: 2021-04-01
Also published as: JPWO2021059935A1; CN114144221B; CN114144221A

Abstract

A catheter (10) is provided with: a flexible outer tube (24); an inner tube (50) provided in an inner cavity (30a) of the outer tube (24) to be movable in the axial direction relative to the outer tube (24); and a flexible annular distal end member (22) connected to a distal end portion of the inner tube (50) without being connected to the outer tube (24). The distal end member (22) has such characteristics that, by pushing the inner tube (50) in the outer tube (24) in the distal end direction in a state in which an endoscope (15) is inserted into an inner cavity (22a) of the distal end member (22), the distal end member (22) protrudes from a distal end opening (24a) of the outer tube (24) in the distal end direction without being supported by the endoscope (15).

Description

catheter

The present invention relates to a catheter.

For example, Japanese Patent No. 3921108 discloses a balloon catheter for treating a lesion (stenosis or occlusion) of the fallopian tube. This balloon catheter includes a flexible outer tube, an inner tube arranged in the inner tube of the outer tube so as to be movable in the axial direction with respect to the outer tube, and the tip and inner tube of the outer tube. It is provided with an annular balloon that connects the tips to each other.

In tuboplasty using a balloon catheter, a balloon inflated in the radial direction of the outer tube is pulled out to the tip of the outer tube to push the lesion (occlusion or stenosis) of the fallopian tube. Perform a derivation process to expand.

Specifically, in the derivation process, the balloon and the fallopian tube are advanced with respect to the outer tube in a state where the balloon is inflated and brought into close contact (support) with the fallopian tube. At this time, since the tip of the balloon is pulled out from the tip opening of the outer tube in the tip direction while the tip is turned over, the advancing distance of the balloon is half the advancing distance of the oviduct. Therefore, when the tip of the fallopian tube reaches the tip of the balloon, it is necessary to reduce the pressure of the fluid for inflating the balloon and retract the fallopian tube with respect to the balloon.

In this way, in the conventional balloon catheter, since the balloon is pressed against the fallopian tube mirror, the fallopian tube mirror (endoscope) is easily damaged, and the fallopian tube mirror needs to be retracted with respect to the balloon. The process may not be carried out efficiently.

The present invention has been made in consideration of such a problem, and an object of the present invention is to provide a catheter capable of reducing damage to the endoscope and efficiently performing a derivation process.

One aspect of the present invention is a catheter comprising a flexible outer tube and an inner tube arranged in the lumen of the outer tube so as to be movable in the axial direction with respect to the outer tube. A flexible tubular tip member connected to the tip of the inner tube without being connected to the outer tube is provided, and the tip member is internally viewed in the lumen of the tip member. By pushing the inner tube toward the tip of the outer tube with the mirror inserted, it is possible to project from the tip opening of the outer tube toward the tip without being supported by the endoscope. Is a catheter.

According to the present invention, since the tip member has a characteristic that it can protrude in the tip direction from the tip opening of the outer tube without being supported by the endoscope, damage to the endoscope can be reduced. Further, since the tip member is not connected to the outer tube, the tip member and the endoscope can be advanced without changing their relative positions (it is necessary to retract the endoscope with respect to the tip member). Absent). Therefore, the derivation process can be performed efficiently.

It is a schematic block diagram of the catheter which concerns on one Embodiment of this invention. It is a partially omitted longitudinal sectional view of the catheter of FIG. FIG. 1 is a first explanatory view of salpingoscopic tuboplasty using the catheter of FIG. FIG. 2 is a second explanatory view of salpingoscopic tuboplasty using the catheter of FIG. FIG. 3 is a third explanatory view of salpingoscopic tuboplasty using the catheter of FIG.

Hereinafter, a suitable embodiment of the catheter according to the present invention will be described with reference to the attached drawings.

The catheter 10 according to an embodiment of the present invention is used, for example, in tuboplasty for treating a lesion (stenosis, occlusion, etc.) of the fallopian tube. However, the catheter 10 may be for treating a lesion in a living organ such as a blood vessel, a bile duct, a trachea, an esophagus, a urethra, or another organ other than the oviduct.

In FIGS. 1 and 2, the catheter 10 is provided at the outer catheter 16, the slider 18 provided on the outer catheter 16, the inner catheter 20 inserted into the outer catheter 16, and the tip of the inner catheter 20. The tip member 22 is provided.

The outer catheter 16 has a long flexible outer tube 24, an outer tube hub 26 provided at the base 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, and 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 tip tip 32 provided at the tip of the outer tube main body 30. Examples of the constituent materials of the outer tube main body 30 and the tip tip 32 include polyolefin (for example, polyethylene, polypropylene, polybutene, etc.), olefin elastomer, polyester (for example, polyethylene terephthalate, etc.), polyester elastomer, and soft polyvinyl chloride. Examples thereof include flexible polymer materials such as vinyl, polyurethane, urethane-based elastomers, polyamides, amide-based elastomers, polytetrafluoroethylene, fluororesin elastomers, polyimides, ethylene-vinyl acetate copolymers, and silicone rubbers.

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

The outer surface of the tip tip 32 is curved to prevent damage to the catheter 10 and living tissue. The tip tip 32 is formed with a lead-out hole 32a for leading the tip member 22 toward the tip of the tip 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, polyetherimide and the like.

The outer tube hub 26 is formed in a hollow shape with a size that is easy to operate manually. The outer tube hub 26 has a first space 34 communicating 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 through which the inner catheter 20 is inserted. A lead-out port 38 communicating with the first space 34 is formed.

Negative pressure is generated in the lead-out port 38 by the action of a suction pump (not shown). As a result, the perfusate led out to the distal end side of the catheter 10 via the inner catheter 20 can be drawn into the out-drawing port 38 via between the outer catheter 16 and the inner catheter 20. The perfusate is, for example, saline. The outer pipe hub 26 is provided with a first seal member 42 for preventing the perfusate 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 it into the screw hole 44 formed at the base end portion of the outer tube hub 26. Examples of the constituent material of the fixing screw 28 are the same as those of the outer tube hub 26.

The slider 18 is provided on the outer peripheral surface of the outer pipe 24 in a state where it can be moved (sliding) in the axial direction of the outer pipe 24. The total length of the slider 18 is shorter than the total length of the outer pipe 24. The slider 18 has a long tubular slider main body 46 and a slider hub 48 provided at a base end portion of the slider main 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 in a ring shape in a size that is easy to operate manually.

In a state where the slider 18 is moved to the most proximal side with respect to the outer pipe 24 (a state where the proximal end of the slider 18 is positioned at the tip of the outer pipe hub 26), the tip side of the outer pipe 24 is from the slider 18. Is exposed to the tip side and curved in an arc shape. With the slider 18 moved to the most 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 main body 46.

The inner catheter 20 includes a long 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 pipe 50 is preferably set to 100 mm or more and 1500 mm or less, and more preferably 200 mm or more and 1000 mm or less.

The inner tube 50 is made of a relatively hard resin (for example, fluororesin, polycarbonate, polyimide, PEEK resin, etc.) or a 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 tip end to the base end.

The inner pipe 50 is arranged in the first lumen 30a of the outer pipe 24 while inserting the first space 34 and the first insertion hole 36 of the outer pipe hub 26. The tip of the inner tube 50 is located in the proximal direction with respect to the tip of the outer tube 24. An outer lumen 54 for guiding the perfusate to the first space 34 is provided between the inner pipe 50 and the outer pipe 24.

The fallopian tube mirror 15 is inserted into the second lumen 50a of the inner tube 50. The fallopian tube mirror 15 is an endoscope for photographing the inside of the fallopian tube. With the fallopian tube mirror 15 inserted in the second lumen 50a of the inner tube 50, an inner lumen 56 for guiding the perfusate to the tip member 22 is formed between the inner tube 50 and the fallopian tube mirror 15. Will be done.

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 has a second space 58 communicating with the second lumen 50a of the inner tube 50, and a second insertion hole 60 located on the proximal end side of the second space 58 and through which the oviduct mirror 15 is inserted. , An introduction port 62 communicating with the second space 58 is formed.

The introduction port 62 introduces the perfusion solution supplied from a perfusion pump or the like (not shown) into the second space 58. The inner pipe hub 52 is provided with a second seal member 66 for preventing the perfusate in the second space 58 from leaking to the outside through the second insertion hole 60.

The tip member 22 is a flexible tubular member, which is flexible and is formed in a tubular shape. The tip member 22 is connected to the tip of the inner tube 50 without being connected to the outer tube 24. The base end portion of the tip member 22 is adhered or fused to the tip end portion of the outer surface of the inner pipe 50. However, the base end portion of the tip member 22 may be adhered or fused to the tip end portion of the inner surface of the inner pipe 50.

The tip member 22 has a lumen 22a communicating with the inner lumen 56. The tip member 22 is not supported by the fallopian tube mirror 15 by pushing the inner tube 50 toward the tip of the outer tube 24 with the fallopian tube mirror 15 inserted in the lumen 22a of the outer tube 24. It has the property of being able to protrude in the tip direction from the tip opening 24a. In addition, the tip member 22 has a property of being able to expand a lesion portion which is an occluded portion or a stenotic portion of the oviduct without being supported by the oviduct mirror 15 as the tip member 22 protrudes in the tip direction. This characteristic is due to the rigidity of the tip member 22.

The tip member 22 is made of a resin material such as urethane or polyester elastomer. The shore D hardness of the tip member 22 is 30 or more. The outer diameter of the tip member 22 is preferably set to 1.2 mm or more and 1.5 mm or less, and more preferably 1.3 mm. The wall thickness of the tip member 22 is preferably set to 0.2 mm or more and 0.4 mm, and more preferably 0.3 mm.

A lubricating film 70 is provided on the outer surface of the tip member 22 in order to reduce frictional resistance. The lubricating film 70 is formed, for example, by coating the outer surface of the tip member 22 with a hydrophilic polymer.

The tip member 22 has a tubular portion 72 into which the oviduct mirror 15 is inserted, and a tip wall portion 74 that covers the opening at the tip of the tubular portion 72. The tubular portion 72 has a substantially constant outer diameter and a substantially constant inner diameter over the entire length. The outer peripheral shape of the tubular portion 72 is formed in a circular shape. The tip wall portion 74 bulges hemispherically in the tip direction. The diameter of the tip wall portion 74 may be reduced in a tapered shape in the tip direction.

An outflow hole 78 for allowing the perfusate to flow out is formed through the tip wall portion 74. The outflow hole 78 is located on the axis of the tip member 22. The diameter of the outflow hole 78 is less than 0.6 mm. That is, the diameter of the outflow hole 78 is smaller than the outer diameter of the fallopian tube mirror 15. An outer space S communicating with the lead-out hole 32a and the outer lumen 54 is formed between the tip member 22 and the outer pipe main body 30.

Next, tubuloscopic tuboplasty using the catheter 10 configured in this way will be described.

In tuboplasty, as shown in FIG. 3, the operator (operator) inserts the catheter 10 transcervically to the uterine cavity 200, and the tip of the outer tube 24 is the egg of the fallopian tube 202. Bring it closer to the tube opening 202a (insertion step). At this time, the operator puts the fallopian tube mirror 15 in the catheter 10 so that the tip of the fallopian tube mirror 15 is close to the outflow hole 78 of the tip member 22 (the tip of the fallopian tube mirror 15 faces the outflow hole 78). The fallopian tube opening 202a is confirmed by the image of the fallopian tube mirror 15 that is inserted and displayed on the monitor.

Subsequently, a lead-out step is performed in which the tip member 22 is led out toward the tip of the outer tube 24 to spread the lesion portion 204 of the oviduct 202. Specifically, as shown in FIG. 4, the operator pushes the inner tube 50 toward the tip of the outer tube 24 and advances the fallopian tube mirror 15 with the fixing screw 28 loosened (advance step). .. As a result, in the tip member 22 and the fallopian tube mirror 15, the tip opening 24a of the outer tube 24 remains in a state where the tip of the fallopian tube mirror 15 is located near the outflow hole 78 of the tip member 22 (the tip of the tip member 22). Protrudes in the direction of the tip.

Further, the perfusate is supplied to the introduction port 62 and the fluid in the outlet port 38 is sucked (perfusion solution supply step). Then, the perfusate supplied to the introduction port 62 flows through the second space 58, the inner lumen 56, and the lumen 22a of the tip member 22, and flows out from the outflow hole 78 to the outside of the tip member 22 (inside the oviduct 202). To do. The perfusate that has flowed out into the oviduct 202 is sucked into the outer space S through the lead-out hole 32a while contacting the outer surface (lubricating membrane 70) of the tip member 22. The perfusate guided to the outer space S is discharged to the outside through the outer lumen 54, the first space 34, and the outlet port 38. As a result, the outer surface of the tip member 22 becomes wet with the perfusate. In this perfusate supply step, it is not necessary to suck the fluid in the outlet port 38.

Subsequently, the operator determines whether or not the tip member 22 has reached the lesion portion 204 based on the image of the fallopian tube mirror 15. Then, as shown in FIG. 5, when the tip member 22 reaches the lesion portion 204, the lesion portion 204 is expanded by the tip member 22. At this time, the tip member 22 spreads the lesion portion 204 without being supported by the fallopian tube mirror 15. This improves the stenosis or obstruction of the oviduct 202. After expanding the lesion 204, the operator removes the catheter 10 (removal step). Before removing the catheter 10, physiological saline is injected through the introduction port 62, then the fallopian tube mirror 15 is inserted, and the catheter 10 is removed while observing the inside of the fallopian tube 202 with the fallopian tube mirror 15. May be good. This completes the salpingoscopic tuboplasty.

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

The catheter 10 includes a flexible tubular tip member 22 connected to the tip of the inner tube 50 without being connected to the outer tube 24. By pushing the lumen 22a of the tip member 22 in the tip direction with respect to the outer tube 24, the tip member 22 projects in the tip direction from the tip opening 24a of the outer tube 24 without being supported by the oviduct mirror 15. Has the properties that are possible.

According to such a configuration, the tip member 22 has a characteristic that it can protrude in the tip direction from the tip opening 24a of the outer tube 24 in a state where the tip member 22 is not supported by the fallopian tube mirror 15, so that the fallopian tube mirror 15 is damaged. Can be reduced. Further, since the tip member 22 is not connected to the outer tube 24, the tip member 22 and the fallopian tube mirror 15 can be advanced without changing the relative positions (the fallopian tube mirror with respect to the tip member 22). There is no need to retract 15). Therefore, the derivation process can be performed efficiently.

The tip member 22 has a characteristic that the lesion portion 204, which is an obstructed portion or a narrowed portion of the fallopian tube 202, can be expanded without being supported by the oviduct mirror 15 as the tip member 22 protrudes in the tip direction.

With such a configuration, damage to the fallopian tube mirror 15 can be further reduced.

The shore D hardness of the tip member 22 is 30 or more.

According to such a configuration, the lesion portion 204 of the fallopian tube 202 can be easily expanded without being supported by the fallopian tube mirror 15.

The tip member 22 has a tubular portion 72 into which the oviduct mirror 15 is inserted, and a tip wall portion 74 that covers the opening at the tip of the tubular portion 72.

According to such a configuration, the lesion portion 204 of the oviduct 202 can be efficiently expanded by the tip member 22.

The perfusate flows through the lumen 22a of the tip member 22, and the outflow hole 78 for letting the perfusate flow out of the tip member 22 is formed through the tip wall portion 74.

According to such a configuration, the perfusate that has flowed out of the tip member 22 from the outflow hole 78 can be brought into contact with the outer surface of the tip member 22, so that the outer surface of the tip member 22 and the inner wall surface of the oviduct 202 can be brought into contact with each other. Friction resistance can be reduced by the perfusate.

The outflow hole 78 is located on the axis of the tip member 22.

According to such a configuration, the tip of the fallopian tube mirror 15 can face the outflow hole 78. As a result, the inside of the fallopian tube 202 can be photographed by the fallopian tube mirror 15 through the outflow hole 78.

The diameter of the outflow hole 78 is less than 0.6 mm.

According to such a configuration, the diameter of the outflow hole 78 can be made smaller than the outer diameter of the oviduct mirror 15, so that the oviduct mirror 15 projects to the tip side of the tip member 22 through the outflow hole 78. It can be suppressed.

An outer space S for sucking the perfusate that has flowed out of the tip member 22 from the outflow hole 78 is formed between the outer pipe 24 and the tip member 22.

According to such a configuration, the perfusate that has flowed out from the outflow hole 78 can be efficiently brought into contact with the outer surface of the tip member 22.

A lubricating film 70 is provided on the outer surface of the tip member 22.

According to such a configuration, the frictional resistance between the outer surface of the tip member 22 and the inner wall surface of the oviduct 202 (lesion portion 204) can be further reduced.

The catheter 10 may include a fallopian tube mirror 15. In this case, the fallopian tube mirror 15 may be fixed to the tip member 22 so that its tip surface faces the outflow hole 78. According to such a configuration, the misalignment between the tip of the oviduct mirror 15 and the outflow hole 78 can be effectively suppressed. The outflow hole 78 may not be formed in the tip wall portion 74. In this case, for example, by forming the tip wall portion 74 transparently, the inside of the fallopian tube can be photographed by the oviduct mirror 15. The diameter of the outflow hole 78 may be 0.6 mm or more. In this case, the wall surface forming the outflow hole 78 can be made difficult or invisible in the image of the fallopian tube mirror 15.

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

The above embodiments can be summarized as follows.

In the above embodiment, a flexible outer tube (24) and an inner tube (50) arranged in the inner tube (30a) of the outer tube so as to be movable in the axial direction with respect to the outer tube. A catheter (10) comprising the above, comprising a flexible tubular tip member (22) connected to the tip of the inner tube without being connected to the outer tube. The tip member is not supported by the endoscope by pushing the inner tube toward the tip of the outer tube with the endoscope (15) inserted in the cavity (22a) of the tip member. Disclosed is a catheter having the property of being able to protrude in the distal direction from the distal end opening (24a) of the outer tube in a state.

In the above-mentioned catheter, the tip member can push out a lesion (204) which is an obstruction or a stenosis of a biological tube (202) without being supported by the endoscope as the tip member protrudes in the tip direction. It may have various characteristics.

In the above catheter, the characteristic may be the rigidity of the tip member.

In the above catheter, the shore D hardness of the tip member may be 30 or more.

In the catheter, the tip member may have a tubular portion (72) into which the endoscope is inserted and a tip wall portion (74) that covers an opening at the tip of the tubular portion.

In the catheter, the perfusate flows through the cavity of the tip member, and an outflow hole (78) for draining the perfusate to the outside of the tip member is formed through the tip wall portion. May be done.

In the above catheter, the outflow hole may be located on the axis of the tip member.

In the above catheter, the diameter of the outflow hole may be less than 0.6 mm.

In the catheter, an outer space (S) for sucking the perfusate that has flowed out of the tip member from the outflow hole may be formed between the outer tube and the tip member.

In the above catheter, a lubricating film (70) may be provided on the outer surface of the tip member.

Claims

A catheter comprising a flexible outer tube and an inner tube disposed in the lumen of the outer tube so as to be movable in the axial direction with respect to the outer tube.
A flexible tubular tip member connected to the tip of the inner tube without being connected to the outer tube.
The tip member is not supported by the endoscope by pushing the inner tube toward the tip of the outer tube with the endoscope inserted in the cavity of the tip member. A catheter having the property of being able to protrude in the distal direction from the distal opening of the catheter.
The catheter according to claim 1.
The tip member is a catheter having a property of being able to expand a lesion portion which is an occluded portion or a stenotic portion of a biological tube without being supported by the endoscope as the tip member protrudes in the tip direction.
The catheter according to claim 1 or 2.
A catheter whose characteristic is the rigidity of the tip member.
The catheter according to claim 3.
A catheter having a shore D hardness of 30 or more for the tip member.
The catheter according to any one of claims 1 to 4.
The tip member
The tubular part into which the endoscope is inserted and
A catheter having a tip wall portion that covers an opening at the tip of the tubular portion.
The catheter according to claim 5.
A perfusate flows through the lumen of the tip member,
A catheter in which an outflow hole for allowing the perfusate to flow out of the tip member is formed through the tip wall portion.
The catheter according to claim 6.
The outflow hole is a catheter located on the axis of the tip member.
The catheter according to claim 6 or 7.
A catheter having an outflow hole diameter of less than 0.6 mm.
The catheter according to any one of claims 6 to 8.
A catheter in which an outer space for sucking the perfusate that has flowed out of the tip member from the outflow hole is formed between the outer tube and the tip member.
The catheter according to any one of claims 1 to 9.
A catheter provided with a lubricating film on the outer surface of the tip member.