WO2021192538A1

WO2021192538A1 - Catheter

Info

Publication number: WO2021192538A1
Application number: PCT/JP2021/001476
Authority: WO
Inventors: 大沢悠; 澤田賢志
Original assignee: テルモ株式会社
Priority date: 2020-03-27
Filing date: 2021-01-18
Publication date: 2021-09-30
Also published as: JP2023062710A

Abstract

Provided is a catheter that can send a high-oxygen solution to the brain in a state where the position of the catheter is fixed.　A catheter (10) includes a tube body (20) that is inserted into a living body. The tube body (20) includes, at the proximal end, an entrance part (35A) and an exit part (36a) which are for a fluid. The entrance part (35a) communicates with an injection port (30) that is formed on the distal end of the tube body (20). The exit part (36a) communicates with a suction port (31) that is provided closer to the proximal end than the injection port (30) is. The catheter includes a balloon that presses the tube body (20) against the living body.

Description

catheter

The present invention relates to a catheter that is inserted through the spine and sends a hyperoxygen solution to the brain.

In the treatment of cerebral infarction, treatment methods such as thrombolytic therapy and thrombus recovery therapy have been established. However, these treatments are often difficult due to the risk of bleeding and the effects of poor access. For this reason, most treatments for cerebral infarction are limited to medical treatment.

As one of the treatments for cerebral infarction, it is conceivable to approach the brain with an oxygenated solution and deliver oxygen from other than transvascular. This treatment requires a catheter that is inserted through the spine and has a tip that reaches near the brain. Examples of the catheter inserted from the spine include those listed in Patent Document 1.

Japanese Unexamined Patent Publication No. 2016-172087

The catheter described in Patent Document 1 is a device that is inserted into the spine to remove and return cerebrospinal fluid, and cannot be used for the above-mentioned treatment. In the above-mentioned treatment, it can be imagined that the position of the catheter easily moves even though the tip of the catheter reaches the vicinity of the brain, which is not preferable in terms of safety.

The present invention has been made to solve the above-mentioned problems, and an object of the present invention is to provide a catheter capable of delivering a high oxygen solution to the brain in a fixed position.

The catheter according to the present invention that achieves the above object is a catheter having a tube body to be inserted into a living body.
The pipe body has a fluid inlet and outlet at the base end, and has a fluid inlet and outlet.
The inlet portion communicates with an injection port formed at the tip end portion of the pipe body, and communicates with the injection port.
The outlet portion communicates with a suction port provided on the proximal end side of the injection port.
It has a balloon that presses the tube body against the living body.

The catheter configured as described above can inject the high oxygen solution around the brain from the injection port, suck the cerebrospinal fluid from the suction port, and send the high oxygen solution to the brain while suppressing the increase in intracranial pressure. .. Further, since the position of the tube body can be fixed by the balloon of the catheter, the tube body and its tip can be prevented from moving in the vicinity of the brain.

Further, a plurality of the suction ports may be formed along the length direction of the pipe body. As a result, the catheter can efficiently suck cerebrospinal fluid through the suction port, so that the increase in intracranial pressure can be effectively suppressed.

Further, the inlet portion may be connected to the supply portion of the artificial cerebrospinal fluid, and the outlet portion may be connected to the collection portion of the cerebrospinal fluid. This allows the catheter to inject artificial cerebrospinal fluid from the inlet through the inlet and aspirate cerebrospinal fluid from the suction port through the outlet.

Further, the balloon is provided on the proximal end side of the suction port. As a result, the suction port is located on the peripheral side of the spinal cord from the balloon, so that the suction port can efficiently suck cerebrospinal fluid at a position with a low risk to the spinal cord.

Further, the balloon may be provided at a position near the suction port and at the same circumferential position as the suction port. As a result, the catheter can form a space around the suction port by expanding the balloon and pressing the tube body against the wall of the living body cavity, so that the suction port is not blocked. ..

Further, the tube body may have an intracranial pressure sensor at the tip. This allows the operator to perform the procedure while checking the intracranial pressure.

Further, the tube body may have an oxygen concentration sensor at the tip thereof. This allows the operator to perform the procedure while checking the oxygen concentration at the tip of the tube body.

It is a front view of the catheter of this embodiment. It is an enlarged cross-sectional view of the vicinity where a balloon and a suction port are provided in a catheter. It is a schematic enlarged view of the catheter in the state where the balloon is expanded in the spinal canal. It is a front view of the vicinity of a suction port of a catheter provided with a recess in the tube body.

Hereinafter, embodiments of the present invention will be described with reference to the drawings. The dimensional ratios in the drawings may be exaggerated and differ from the actual ratios for convenience of explanation. Further, in the present specification, the side of the catheter 10 to be inserted into the living body is referred to as "tip" or "tip side", and the hand side to be operated is referred to as "base end" or "base end side".

The catheter 10 according to the embodiment of the present invention is inserted into the spinal canal from the lumbar spine, the tip of the catheter 10 is delivered to the vicinity of the brain to inject highly oxygenated artificial cerebrospinal fluid, and the cerebrospinal fluid is injected at the proximal end side. The cerebral infarction is treated by inhaling.

As shown in FIG. 1, the catheter 10 has a long tube body 20. The tube body 20 has an intracranial pressure sensor 22 at its tip. An injection port 30 that opens toward the tip is formed at the tip of the tube body 20. A plurality of suction ports 31 are formed in the middle portion of the tube body 20.

The base end of the pipe body 20 is branched into two, an inlet pipe 35 and an outlet pipe 36. Further, a balloon 21 that can be expanded and contracted and a balloon tube 37 that supplies an expansion fluid to the balloon 21 are provided at the base end portion of the tube body 20.

An inlet portion 35a is provided at the base end portion of the inlet pipe 35. A liquid supply unit 50 for supplying highly oxygenated artificial cerebrospinal fluid is connected to the inlet portion 35a. An outlet portion 36a is provided at the base end portion of the outlet pipe 36. A cerebrospinal fluid collection unit 52 is connected to the outlet unit 36a. A fluid introduction portion 37a is provided at the base end portion of the balloon tube 37. An expansion fluid supply unit 53 is connected to the fluid introduction unit 37a. As the inlet portion 35a, the outlet portion 36a, and the fluid introduction portion 37a, for example, a hub can be used.

As shown in FIG. 2, an injection lumen 40 continuous from the inlet portion 35a of the inlet pipe 35 is formed inside the pipe body 20. The injection lumen 40 extends to the tip of the tube body 20 and communicates with the injection port 30. Further, inside the pipe body 20, a suction lumen 41 is formed which is continuous from the outlet portion 36a of the outlet pipe 36 and communicates with the suction port 31.

Inside the balloon tube 37, an expansion lumen 42 is formed that is continuous from the fluid introduction portion 37a and communicates with the inside of the balloon 21. The balloon 21 can be expanded by injecting an expansion fluid into the balloon 21 via the expansion lumen 42. The expansion fluid may be a gas or a liquid, and for example, a gas such as helium gas, CO ₂ gas, O ₂ gas, or laughing gas, physiological saline, a contrast medium, or a mixed liquid thereof can be used.

The balloon 21 is a side portion of the tube main body 20 and is arranged on the proximal end side from the suction port 31. As a result, the balloon 21 can press the tube body 20 in the spinal canal in the radial direction. Further, the balloon 21 is provided at the same circumferential position as the suction port 31 and at a position near the suction port 31. The balloon 21 and the suction port 31 are located near the insertion position when the catheter 10 is inserted into the spine.

The balloon 21 may have a shape that extends in the opposite direction of the tube body 20. As a result, the balloon 21 can fix the tube body 20 more stably.

In this embodiment, four suction ports 31 are provided. However, the number of suction ports 31 is not limited to this. Further, the position of the suction port 31 is not limited to the position shown in FIG. 1, and can be provided at an arbitrary position on the tip side of the balloon 21.

The tube body 20 and the balloon tube 37 are preferably formed of a material having a certain degree of flexibility. Examples of such a material include polyolefins such as polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof, and a soft polyvinyl chloride resin. Examples thereof include fluororesins such as polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane and polytetrafluoroethylene, silicone rubber and latex rubber.

The balloon 21 is formed of a thin-film balloon film, and is formed of a flexible material like the tube body 20 and the balloon tube 37. As the material of the balloon 21, the ones mentioned above for the tube main body 20 and the balloon tube 37 can be used, or other materials may be used.

Next, a treatment method using the catheter 10 of the present embodiment will be described. The catheter 10 is percutaneously inserted into the living body and introduced into the spinal canal through the interlumbar or the gap between the lumbar vertebra and the sacrum. Specifically, the catheter 10 is introduced into the spinal canal using the space of L3-L4, L4-L5, or L5-S1. However, the catheter 10 may be introduced into the spinal canal from a position other than these.

The catheter 10 introduced into the spinal canal is inserted toward the brain. The catheter 10 is inserted until the injection port 30 at the tip reaches the vicinity of the brain. The maximum insertion position of the catheter 10 is preferably up to the cisterna magna.

After inserting the catheter 10, the expansion fluid is injected from the expansion fluid supply unit 53 into the balloon 21 via the expansion lumen 42 to expand the balloon 21. As shown in FIG.
When the balloon 21 expands in the spinal canal P, the tube body 20 is pressed against the canal wall of the spinal canal P. As a result, the tube body 20 is fixed so as not to move in the length direction, so that the catheter 10 does not shift during the treatment, and the safety can be improved.

Further, when the balloon 21 expands and the tube body 20 is pressed against the tube wall of the spinal canal P, a gap is formed between the suction port 31 and the tube wall of the spinal canal P. Therefore, the cerebrospinal fluid can be smoothly sucked from the suction port 31 without blocking the suction port 31. Further, since a plurality of suction ports 31 are formed along the length direction of the tube body 20, cerebrospinal fluid can be efficiently sucked and an increase in intracranial pressure can be suppressed. The suction ports 31 may be arranged in a row along the length direction of the pipe body 20, but may be arranged so that the rows are staggered.

It is desirable that the balloon 21 does not completely occlude the inside of the spinal canal. As a result, it is possible to prevent the cerebrospinal fluid in the spinal canal below the balloon 21 from becoming impermeable. Therefore, the shape of the balloon 21 may be a simple circle or a shape that holds a flow passage inside.

After the balloon 21 is expanded, the highly oxygenated artificial cerebrospinal fluid is supplied from the liquid supply unit 50 and injected from the injection port 30 via the injection lumen 40. The artificial cerebrospinal fluid is supplied to the brain from the injection port 30. When supplying the artificial cerebrospinal fluid, the cerebrospinal fluid collection unit 52 is also operated to suck the cerebrospinal fluid in the spinal canal from the suction port 31 via the suction lumen 41. The suction of cerebrospinal fluid is preferably equal to the injection amount of artificial spinal fluid. As a result, an increase in intracranial pressure can be suppressed. Since the suction port 31 is formed on the base end side of the tube body 20, the artificial cerebrospinal fluid injected from the tip of the tube body 20 is not directly sucked, and the artificial cerebrospinal fluid is hyperoxygenated into the brain. The liquid can be reliably supplied. During the supply of artificial cerebrospinal fluid and the suction of cerebrospinal fluid, the intracranial pressure measured by the intracranial pressure sensor 22 is checked at any time. Further, an oxygen concentration sensor may be provided at the tip of the tube body 20. By providing the oxygen concentration sensor, the oxygen concentration at the tip of the tube body 20 can be checked at any time.

The cerebrospinal fluid collected by the cerebrospinal fluid collection unit 52 is discarded as it is, but the collected cerebrospinal fluid may be passed through a filter and then supplied to the brain together with the artificial cerebrospinal fluid. In that case, the cerebrospinal fluid collection unit 52 and the liquid supply unit 50 in FIG. 2 may be the same, or may be distributed through a filter or the like.

In addition, when the fluidity of cerebrospinal fluid is poor, the balloon 21 can be repeatedly expanded and contracted in the spinal canal. This may increase the fluidity of the cerebrospinal fluid.

When the supply of artificial cerebrospinal fluid is completed, the balloon 21 is contracted and the catheter 10 is removed from the living body.

As described above, the catheter 10 according to the present embodiment is a catheter 10 having a tube body 20 to be inserted into the living body, and the tube body 20 has a fluid inlet portion 35a and a fluid inlet portion 35a and an outlet portion 36a at the proximal end portion. The inlet 35a communicates with the injection port 30 formed at the tip of the tube body 20, the outlet 36a communicates with the suction port 31 provided on the proximal end side of the injection port 30, and the tube body 20 is used as a living body. Has a balloon 21 that presses against. The catheter 10 can suck cerebrospinal fluid from the suction port 31 while injecting the high oxygen solution into the brain from the injection port 30, and can send the high oxygen solution to the brain while suppressing an increase in intracranial pressure. Further, since the position of the tube body 20 can be fixed by the balloon 21 of the catheter 10, the tip of the tube body 20 can be prevented from moving in the vicinity of the brain.

Further, a plurality of suction ports 31 may be formed along the length direction of the pipe body 20. As a result, the catheter 10 can efficiently suck the cerebrospinal fluid through the suction port 31, so that the increase in the intracranial pressure can be effectively suppressed.

Further, the inlet portion 35a may be connected to the liquid supply portion 50, and the outlet portion 36a may be connected to the cerebrospinal fluid collection unit 52. As a result, the catheter 10 can inject the liquid from the injection port 30 through the inlet 35a and suck the cerebrospinal fluid from the suction port 31 through the outlet 36a.

Further, the balloon 21 may be provided on the proximal end side of the suction port 31. As a result, the suction port 31 has more cerebrospinal fluid than the balloon 21 and is arranged on the peripheral side with respect to the spinal cord. Therefore, the suction port 31 efficiently sucks the cerebrospinal fluid at a position having a low risk to the spinal cord. can.

Further, the balloon 21 may be provided at a position near the suction port 31 and at the same circumferential position as the suction port 31. As a result, the catheter 10 can form a space around the suction port 31 by expanding the balloon 21 and pressing the tube body 20 against the wall of the living body so that the suction port 31 is not blocked. Can be.

Further, the tube body 20 may have an intracranial pressure sensor 22 at the tip end portion. This allows the operator to perform the procedure while checking the intracranial pressure.

Further, the tube body 20 may have an oxygen concentration sensor at the tip thereof. As a result, the operator can perform the treatment while checking the oxygen concentration at the tip of the tube body 20.

Further, the treatment method according to the present embodiment includes a step of introducing the tube body 20 into the spine from the tip having the injection port 30, a step of delivering the tip of the tube body 20 to the vicinity of the brain, and a balloon 21. A step of expanding and pressing and fixing the tube body 20 into the spine, a step of injecting artificial spinal fluid from the injection port 30, and a step of sucking cerebrospinal fluid from a suction port 31 provided on the proximal end side of the injection port 30. Has. This treatment method can supply artificial cerebrospinal fluid to the brain while suppressing an increase in intracranial pressure. In addition, this treatment method can prevent the position of the tube body 20 from changing when the artificial cerebrospinal fluid is supplied by expanding the balloon 21.

It is also possible to prevent the balloon 21 from completely obstructing the living body cavity when the balloon 21 is expanded. Thereby, this treatment method can prevent the cerebrospinal fluid in the spinal canal below the balloon 21 from becoming impermeable.

It is also possible to repeatedly expand and contract the balloon 21 in the lumen of the living body. Thereby, this treatment method may be able to increase the fluidity of cerebrospinal fluid.

The present invention is not limited to the above-described embodiment, and various modifications can be made by those skilled in the art within the technical idea of the present invention. As shown in FIG. 4, a recess 33 may be formed in the tube body 20 and the suction port 31 may be arranged in the recess 33. As a result, it is possible to more reliably prevent the suction port 31 from being blocked in the spinal canal, and it is possible to smoothly suck cerebrospinal fluid and suppress an increase in intracranial pressure.

Further, the number of balloons 21 is not limited to one, and a plurality of balloons 21 may be provided. When a plurality of balloons 21 are provided, the expansion lumen 42 can be common. One of the plurality of balloons 21 may be expanded outside the body. When the balloon 21 outside the body expands and comes into contact with the outside of the living body, it is possible to more reliably prevent the position of the tube body 20 from shifting.

Further, a marker having a contrast medium may be provided at the tip of the tube body 20. As a result, the tip of the pipe body 20 can be prevented from being inserted into a predetermined position, for example, above the large tank.

Further, the liquid injected from the injection port 30 may be other than the artificial cerebrospinal fluid. The solution for increasing oxygen may be a highly gas-soluble liquid such as fluorocarbon, an emulsion thereof, or a solution having no effect on the living body such as physiological saline. Further, the solution may not be hyperoxygenated, or may be cooled or heated.

Further, the catheter 10 may have a safety mechanism in which the intracranial pressure is measured by the intracranial pressure sensor 22 and the inflow of cerebrospinal fluid is stopped according to a preset intracranial pressure threshold. Further, the catheter 10 may have a mechanism for monitoring the value measured by the intracranial pressure sensor 22 and automatically adjusting the balance between infusion and suction of cerebrospinal fluid.

Also, in combination with or in place of the intracranial pressure sensor 22, at least one of carbon dioxide concentration, carbon dioxide partial pressure (pCO2), pH, mineral components (Na, K, Glucose), creatinine, and cerebrospinal fluid flow rate. It may have a sensor to measure one. In addition, these measured values can be used to calculate oxygen consumption (VO2) and oxygen supply (DO2), which can be used for feedback. For example, by incorporating an optical fiber type sensor into the catheter 10, the sensor can measure a value at an arbitrary position of the catheter 10.

Alternatively, a guide wire may be used to insert the catheter 10. In this case, the guide wire is inserted into the injection lumen, and the tube body 20 is inserted into the living body while the guide wire precedes the injection lumen. When the tube body 20 reaches a predetermined position, the guide wire is removed.

The catheter 10 can also be used for treatments other than cerebral infarction. For example, for cerebral hemorrhage, subarachnoid hemorrhage, hydrocephalus, brain diseases such as Alzheimer's disease, and spinal cord ischemia, it is considered effective to inject a high oxygen solution or forcibly circulate cerebrospinal fluid. The catheter 10 can be used for the disease.

Note that this application is based on Japanese Patent Application No. 2020-58236 filed on March 27, 2020, and the disclosure contents thereof are referred to and incorporated as a whole.

10 Catheter 20 Tube body 21 Balloon 22 Cranial pressure sensor 30 Injection port 31 Suction port 33 Recess 35 Inlet tube 35a Inlet 36 Outlet tube 36a Outlet 37 Balloon tube 37a Fluid introduction 40 Injection lumen 41 Suction lumen 42 Expansion lumen 50 Liquid Supply unit 52 Spinal fluid collection unit 53 Expansion fluid supply unit

Claims

A catheter having a tube body that is inserted into the living body.
The pipe body has a fluid inlet and outlet at the base end, and has a fluid inlet and outlet.
The inlet portion communicates with an injection port formed at the tip end portion of the pipe body, and communicates with the injection port.
The outlet portion communicates with a suction port provided on the proximal end side of the injection port.
A catheter having a balloon that presses the tube body against a living body.
The catheter according to claim 1, wherein a plurality of suction ports are formed along the length direction of the tube body.
The catheter according to claim 1 or 2, wherein the inlet portion is connected to a liquid supply portion and the outlet portion is connected to a cerebrospinal fluid collection unit.
The catheter according to any one of claims 1 to 3, wherein the balloon is provided on the proximal end side of the suction port.
The catheter according to claim 4, wherein the balloon is located near the suction port and is provided at the same circumferential position as the suction port.
The catheter according to any one of claims 1 to 5, wherein the tube body has an intracranial pressure sensor at the tip.
The catheter according to any one of claims 1 to 6, wherein the tube body has an oxygen concentration sensor at the tip thereof.