JP2014200356A - Treatment device and use method thereof - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a treatment device capable of suppressing an amount of medicine to be administered in a living body.SOLUTION: A treatment device including an inflatable closure balloon 2 disposed near a distal end of an elongate shaft 1 is inserted into a living body lumen, and the closure balloon 2 is inflated to close the adjacency of an affected area in the living body lumen filled with a water component W and to form a closed chamber 17 in the living body lumen. A water removal part absorbs the water component W in the closed chamber 17 via a semipermeable membrane 16 exposed to the interior of the closed chamber 17 so as to thicken a medical agent D being present in the closed chamber 17.

Description

  The present invention relates to a therapeutic device and a method of using the same, and more particularly to a therapeutic device for supplying a drug to a lesion in a living body lumen and a method of using the same.

  In the medical field, when a lesion such as a stenosis or occlusion occurs in a living body lumen such as a blood vessel, a bile duct, a trachea, an esophagus, or a urethra, a balloon catheter for expanding the lesion and performing treatment It is used. This balloon catheter generally has a structure in which an expandable balloon is disposed in the vicinity of the distal end portion of a long shaft, and a guide wire introduced from the distal end of the shaft is led out to the proximal end side through the inside of the shaft. Have For example, in the treatment of myocardial infarction or angina caused by the occurrence of a stenosis in a blood vessel, a catheter is inserted into the blood vessel while being guided by a guide wire introduced from the tip of the shaft. A balloon disposed in the vicinity of the distal end portion is positioned in the narrowed portion. Then, by expanding the balloon in the radial direction, the stenosis portion is pushed and expanded to ensure blood flow in the blood vessel and to treat the stenosis portion with a drug or the like.

However, when a plurality of stenosis portions are generated in the blood vessel, it takes a lot of time and labor to insert the catheter to the target lesion portion. In particular, when there is an occlusion that closes the inside of the blood vessel, it is difficult to deliver the guide wire to the target lesion. Therefore, a balloon catheter has been proposed for administering a drug that decomposes the occluded portion or the like in a blood vessel.
For example, Patent Document 1 discloses a method of applying a collagen-containing preparation to a calcified lesion that occludes an artery. When the balloon catheter inserted into the artery is advanced to the vicinity of the occlusion portion while performing fluoroscopy, the balloon is expanded to seal the artery, and a drug is supplied between the balloon and the occlusion portion.

JP-T-2005-503820

In this way, by confining the drug between the balloon that blocks the inside of the artery and the occluded part, it is possible to suppress the drug from diffusing into the artery and enhance the action effect of the drug. In particular, in a body lumen filled with a water component such as a blood vessel, the drug easily moves together with the water component, so it is effective to confine the drug in the vicinity of the occlusion with a balloon to prevent diffusion. It becomes.
However, since the drug supplied from the balloon catheter into the blood vessel is diluted by the blood in the blood vessel, an excessive amount of drug is supplied into the blood vessel in order to perform the decomposition reaction of the occluded portion with the optimal drug concentration. There was a risk that this would be a burden on the living body.

  The present invention has been made to solve such conventional problems, and it is an object of the present invention to provide a therapeutic device capable of suppressing the amount of a drug administered into a living body and a method for using the same. .

  The therapeutic device according to the present invention includes an elongated shaft for insertion into a living body lumen and an expandable arrangement in the vicinity of the distal end portion of the shaft, and seals the vicinity of a lesioned part in the living body lumen filled with a water component. A sealing balloon that expands to form a sealed chamber in the body lumen and a semipermeable membrane that is exposed in the sealed chamber, and the water component in the sealed chamber is sucked through the semipermeable membrane, thereby blocking the blockage. And a water removal unit for concentrating the drug present in the room.

  Here, the dewatering part has a dewatering balloon with a semipermeable membrane disposed on the outer peripheral part, and the dewatering balloon is disposed near the tip of the shaft and is supplied with a hypertonic solution therein, It is preferable to absorb the water component in the sealed chamber through the semipermeable membrane by osmotic pressure.

In addition, the sealing balloon and the dewatering balloon are integrally formed as an integral balloon, and the integral balloon is expanded by being provided with a semipermeable membrane at the front portion and supplied with a hypertonic solution therein. When the rear part contacts the living body lumen and seals the rear part, a sealing chamber can be formed with the lesion part located in front.
Further, it may further include an auxiliary sealing balloon that is disposed behind the integrated balloon and expands to seal the living body lumen to assist the sealing with the integrated balloon.
Further, the dewatering balloon is disposed in front of the sealing balloon and the semipermeable membrane is disposed in the entire outer peripheral portion, and the sealing balloon is expanded so as to be in contact with the living body lumen and sealed backward. Thus, it is also possible to form a sealed chamber between the lesion located in front of the water removal balloon.

Further, the sealing balloon is composed of a pair of sealing balloons, and the sealing chamber can be formed by expanding the pair of sealing balloons so as to contact the living body lumen.
Further, the water removal balloon may be disposed between a pair of sealing balloons. In addition, at least one of the pair of sealing balloons is formed as an integral balloon integrally formed with the dewatering balloon, and the integral balloon is expanded by being supplied with a hypertonic solution therein, and the outer peripheral portion is a living body tube. A sealing chamber may be formed in contact with the cavity, and a semipermeable membrane may be disposed on the outer peripheral portion exposed in the sealing chamber.

Further, the shaft has a water removal lumen extending from the proximal end portion to the vicinity of the distal end portion, a semipermeable membrane is disposed at the distal end portion of the water removal lumen, and the water removal portion is disposed at the proximal end portion of the water removal lumen. It has a connected water removal pump, and the water component in the sealed chamber can be sucked through the semipermeable membrane by the suction force of the water removal pump.
The shaft preferably has a drug lumen extending from the proximal end portion to the vicinity of the distal end portion, and the drug is preferably supplied into the sealed chamber through the drug lumen.

  A method of using the therapeutic device according to the present invention is to insert a therapeutic device as described above into a living body lumen and expand a sealing balloon, thereby forming a sealed chamber near a lesioned part in the living body lumen. And the chemical | medical agent which exists in a sealing chamber is concentrated by sucking out the water component in a sealing chamber through a semipermeable membrane.

Here, it is preferable that the sealing balloon is moved so as to narrow the sealing chamber while sucking water components from the sealing chamber through the semipermeable membrane.
Further, after the drug is concentrated by sucking out the water component in the sealed chamber, the drug concentrated in the sealed chamber can be diluted by supplying moisture into the sealed chamber through the semipermeable membrane.

  According to the present invention, the drug present in the sealed chamber is concentrated by forming a sealed chamber that seals the vicinity of the lesion and sucking the water component in the sealed chamber through the semipermeable membrane. It becomes possible to suppress the amount of drug.

It is a side view which shows the structure of the therapeutic device which concerns on Embodiment 1 of this invention. FIG. 3 is a cross-sectional view showing a configuration in the vicinity of the distal end portion of the therapeutic device according to the first embodiment. It is a figure which shows a mode that the chemical | medical agent in the blood vessel is concentrated by the therapeutic device which concerns on Embodiment 1. FIG. It is a figure which shows a mode that a therapeutic device is moved ahead so that a sealing chamber may be narrowed. 6 is a side view showing a configuration of a treatment device according to Embodiment 2. FIG. It is a figure which shows a mode that the chemical | medical agent in the blood vessel is concentrated with the therapeutic device which concerns on Embodiment 2. FIG. It is a figure which shows a mode that the chemical | medical agent in a blood vessel is concentrated with the therapeutic device which concerns on the modification of Embodiment 2. FIG. FIG. 10 is a diagram showing a state where a drug in a blood vessel is concentrated by a therapeutic device according to a third embodiment. FIG. 10 is a diagram illustrating a state where a drug in a blood vessel is concentrated by a therapeutic device according to a modification of the third embodiment. It is a figure which shows a mode that the chemical | medical agent in a blood vessel is concentrated with the suction force of a water removal pump. It is a figure which shows a mode that the chemical | medical agent in a blood vessel is diluted with the water supply force of a water supply pump.

Embodiments of the present invention will be described below with reference to the accompanying drawings.
Embodiment 1
FIG. 1 shows a therapeutic device according to Embodiment 1 of the present invention. This therapeutic device has an elongated shaft 1 for insertion into a blood vessel, and an integrated balloon 2 disposed so as to be expandable near the tip of the shaft 1. Further, a GW hub 3 for inserting a guide wire and an expansion liquid hub 4 for supplying an expansion liquid for expanding the integrated balloon 2 are disposed at the proximal end portion of the shaft 1. The GW hub 3 has a port 5, and a guide wire 6 introduced from the tip opening of the shaft 1 is led out from the port 5 through the inside of the shaft 1. The expansion fluid hub 4 has a port 7, and the expansion fluid injected from the port 7 is supplied into the integrated balloon 2 through the shaft 1.
The material for forming the shaft 1 is preferably a material having a certain degree of flexibility, and examples thereof include metals and resins. Examples of the metal include pseudo-elastic alloys (including superelastic alloys) such as Ni-Ti alloys, shape memory alloys, stainless steel (for example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS429, SUS430F, SUS302, etc.), cobalt-based alloys, noble metals such as gold and platinum, tungsten-based alloys, carbon-based materials (including piano wires), and the like. Examples of the resin include polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyvinyl chloride, polyamide, polyamide. Examples thereof include polymer materials such as elastomers, polyesters, polyester elastomers, polyurethanes, polyurethane elastomers, polyimides, fluororesins, mixtures thereof, and the above two or more polymer materials. Moreover, it can be comprised by the multilayer tube etc. which consist of a composite formed from these metals and resin.
The balloon 2 can be made of a flexible material that deforms along the shape of the blood vessel when expanded, for example, a soft material such as rubber.

FIG. 2 shows a configuration in the vicinity of the distal end portion of the treatment device in a state where the integrated balloon 2 is expanded. As shown in FIG. 2, the shaft 1 has a so-called double-pipe structure composed of an outer tube 8 extending from the vicinity of the distal end portion to the proximal end portion and an inner tube 9 disposed inside the outer tube 8. Have The inner tube 9 is connected to the GW hub 3, and a GW lumen 11 extending from the opening 10 at the tip to the port 5 of the GW hub 3 is formed in the inner tube 9. On the other hand, the outer pipe 8 is connected to the expansion liquid hub 4, and the port of the expansion liquid hub 4 is opened from the opening 12 at the tip between the outer peripheral surface of the inner pipe 9 and the inner peripheral surface of the outer pipe 8. An expansion fluid lumen 13 extending to 7 is formed.
Thereby, the guide wire 6 introduced from the distal end opening 10 of the treatment device can be led out from the port 5 through the GW lumen 11 formed inside the shaft 1. In addition, a medicine for treating a lesion in the blood vessel can be supplied from the port 5 of the GW hub 3, and the medicine supplied from the port 5 is opened through the GW lumen 11 to the opening 10 of the inner tube 9. To the outside.

  Here, as a drug, collagenase, pyrophosphate, EDTA (ethylenediaminetetraacetic acid), urokinase, t-PA (tissue-type plasminogen activator) for stenosis that is blocked in vascular due to calcification and thrombus, etc. Etc. can be applied.

The integrated balloon 2 is disposed so as to be attached to the distal end portion of the inner tube 9 and the distal end portion of the outer tube 8 so as to wrap around the opening 12 of the outer tube 8. As a result, the expansion liquid injected from the port 7 of the expansion liquid hub 4 is supplied into the integrated balloon 2 from the opening 12 via the expansion liquid lumen 13. Here, as the expansion liquid, a hypertonic liquid having an osmotic pressure higher than that of blood circulating in the blood vessel is used.
The integrated balloon 2 that is expanded by supplying a hypertonic solution therein is configured such that the rear portion 14 abuts against the blood vessel wall and seals the rear, and blood in the blood vessel is moved from the rear portion 14 side of the integrated balloon 2 to the front portion. Inflow to the 15 side is suppressed. In addition, a semipermeable membrane 16 is disposed on the front portion 15 of the expanded integrated balloon 2, and the semipermeable membrane 16 is interposed between the blood in the blood vessel and the hypertonic solution in the integrated balloon 2. A difference occurs in the osmotic pressure, and components in the blood vessel are sucked into the integrated balloon 2 in accordance with the osmotic pressure difference.

Here, as the semipermeable membrane 16, a membrane that does not transmit a degradation component contained in a drug, such as collagenase, but transmits only a water component contained in blood is used. In addition, a water component shows the component of a comparatively low molecular weight centering on a water | moisture content. For example, by using the semipermeable membrane 16 that transmits only a component having a relatively low molecular weight of 10,000 MW or less, preferably 5000 MW or less, only a component centered on moisture such as a plasma component can be transmitted.
As described above, the integrated balloon 2 functions as a sealing balloon in which the rear portion 14 seals the inside of the blood vessel, and the front portion 15 functions as a dewatering balloon that absorbs water components contained in the blood. It is formed.

As the hypertonic solution, a crystalline solution in which sugars such as glucose or sodium chloride is dissolved can be used, and the crystalline osmotic pressure is adjusted to be higher than the crystalline osmotic pressure of blood. As the hypertonic solution, a colloid solution in which hydroxyethyl starch, dextran or the like is dissolved can be used, and the colloid osmotic pressure is adjusted to be higher than the colloid osmotic pressure of blood.
For example, when a crystalline liquid is used for the hypertonic solution, the semipermeable membrane 16 disposed in the front portion 15 of the integrated balloon 2 is a membrane such as a reverse osmosis membrane (RO membrane) in which salt does not move. it can. When a colloidal solution is used for the hypertonic solution, the semipermeable membrane 16 should be a porous membrane in which protein molecules do not move, such as regenerated cellulose, acetylcellulose, polytetrafluoroethylene, polyester-based polymer alloy, and polysulfone. Can do.

Next, the operation of the first embodiment will be described.
First, as shown in FIG. 3a, blood containing a water component W circulates in the blood vessel V, and a blocking portion B (calcification, thrombus, etc.) is generated so as to block the blood flow. A guide wire 6 of the device is inserted along the blood vessel V to the vicinity of the obstruction. Subsequently, the distal end portion of the shaft 1 is inserted to the vicinity of the closing portion B while being guided by the guide wire 6 inserted to the vicinity of the closing portion B.

  Next, after the tip portion of the shaft 1 is positioned in the vicinity of the blocking portion B, the drug D for decomposing the blocking portion B is supplied to the vicinity of the blocking portion B, and then the hypertonic solution is added to the expansion fluid hub 4. As shown in FIG. 3 b, the liquid is injected into the integrated balloon 2 from the opening 12 of the shaft 1 through the expansion liquid lumen 9. Here, the medicine D can be supplied to the vicinity of the occlusion B using another catheter such as a microcatheter. In addition, by injecting the drug D from the port 5 of the GW hub 3, the drug D can be supplied from the opening 10 of the shaft 1 to the vicinity of the blocking part B via the GW lumen 11. For example, by connecting a Y-shaped branch connector in which two branch ports are formed to the port 5 of the GW hub 3, the guide wire 6 is led out from one branch port, and then from the other branch port. The drug D can be injected, and the drug D can be supplied in the vicinity of the blocking part B.

As shown in FIG. 3c, the integrated balloon 2 to which the hypertonic solution is supplied is expanded until the outer peripheral portion comes into contact with the blood vessel wall, and the rear portion 14 of the integrated balloon 2 blocks the back of the blood vessel V. The blood in the blood vessel V is prevented from flowing from the rear part 14 side to the front part 15 side of the integrated balloon 2. On the other hand, in front of the integrated balloon 2, there is a blocking portion B generated so as to block the blood vessel V. For this reason, between the integrated balloon 2 and the obstruction | occlusion part B, the sealing chamber 17 which suppresses the inflow of the blood from the front and back, and confine | contains the chemical | medical agent D inside is formed.
Thus, by confining the drug D in the sealed chamber 17, it is possible to suppress the drug D from being diffused into the blood vessel V by riding on the blood flow.

In addition, the semipermeable membrane 16 disposed in the front portion 15 of the integrated balloon 2 is exposed in the sealing chamber 17. Further, a hypertonic solution having an osmotic pressure higher than that of the blood in the sealing chamber 17 is supplied into the integrated balloon 2. For this reason, a pressure toward the integrated balloon 2 across the semipermeable membrane 16 acts on the blood in the sealed chamber 17, and the water component W contained in the blood in the sealed chamber 17 passes through the semipermeable membrane 16. The integrated balloon 2 is sucked into the interior.
At this time, since the sealing chamber 17 is sealed by the rear portion 14 and the blocking portion B of the integrated balloon 2, almost no new water component W flows into the sealing chamber 17, and the water component W in the sealing chamber 17 does not flow. As the integrated balloon 2 is sucked into the integrated balloon 2, the amount of water component W in the sealed chamber 17 decreases. Then, the amount of the water component W in the sealed chamber 17 is reduced, so that the drug D trapped in the sealed chamber 17 is concentrated, and the drug D effectively acts on the closed portion B exposed in the sealed chamber 17. be able to.

  For example, when a normally used concentration of the drug D is supplied into the blood vessel V, the concentration of the drug D in the sealed chamber 17 is increased by concentrating by osmotic pressure, and the drug D is allowed to act in a short time. Thus, the closed portion B can be quickly disassembled. It is also possible to supply a drug D having a lower concentration than that normally used into the blood vessel V and concentrate the drug D to the normal concentration in the sealed chamber 17. Thereby, the dose of the medicine D into the living body can be reduced, and the burden on the living body can be reduced.

In this way, by allowing the concentrated drug D to act on the occlusion part B, it can be disassembled to a state where the therapeutic device can be passed through the occlusion part B. For example, as shown in FIG. The blocking portion B can be pushed through with the guide wire 6 led out from the opening 10. Then, after the guide wire 6 is inserted up to the target lesion through the block B, the treatment device can be inserted up to the target lesion by being guided by the guide wire 6.
According to the present embodiment, the sealing chamber 17 that seals the vicinity of the lesion is formed, and the water component W in the sealing chamber 17 is sucked into the integrated balloon 2 using the osmotic pressure. The drug D supplied to the can be quickly concentrated and act on the lesion. In addition, even if the drug D supplied into the blood vessel V is once diluted with blood, the drug D can be returned to a desired concentration by concentration, so there is no need to supply an excessive amount of the drug. The amount of drug to be administered can be suppressed.

In the above embodiment, the integrated balloon 2 is expanded after the drug D is supplied into the blood vessel V. However, after the integrated balloon 2 is expanded until the blood vessel V is sealed, the drug D is It may be supplied into the blood vessel V.
As shown in FIG. 4, the integrated balloon 2 is moved forward so as to narrow the sealed chamber 17 while sucking the water component W in the sealed chamber 17 into the integrated balloon 2 through the semipermeable membrane 16. It is preferable to move. Specifically, the integrated balloon 2 is easily moved forward by sucking out the water component W in the sealed chamber 17. For example, the operator artificially moves the treatment device forward. Alternatively, the therapeutic device may be automatically moved forward. Thus, by narrowing the sealing chamber 17, the drug D concentrated in the sealing chamber 17 can be effectively applied to the blocking portion B.

Next, a method of calculating the amount of water component W (water removal amount) removed from the sealed chamber 17 by osmotic pressure will be described.
The osmotic pressure π (atm) can be generally expressed by the Vanthoff's law defined by π = nRT / V. Here, n is the number of particles (number of moles) in the solution, R is a gas constant (R = 8.31 × 10 ³ Pa · L / K · mol), T is an absolute temperature (K), and V is a volume (dm ³ ) Respectively.
Here, the osmotic pressure of the blood in the sealed chamber 17 is 793.5 (Pa) when the blood has an osmotic pressure equivalent to 0.9% NaCl and the temperature is assumed to be 37 ° C. according to the Vanthoff's law. ) On the other hand, the osmotic pressure of the hypertonic solution supplied into the integrated balloon 2 is 2645 (Pa) when calculated according to the Vanthoff's law assuming that 3% NaCl is used as the hypertonic solution and the temperature is 37 ° C. Thus, since the hypertonic solution in the integrated balloon 2 across the semipermeable membrane 16 has a high osmotic pressure with respect to the blood in the sealed chamber 17, the hypertonic solution from the sealed chamber 17 until the osmotic pressure reaches equilibrium. Movement of the water component W occurs in the integrated balloon 2.

  Therefore, by setting the osmotic pressure of blood in the sealing chamber 17 to 793.5 (Pa), the sealing chamber corresponding to the concentration of the hypertonic solution, the device capacity for storing the hypertonic solution, and the volume of the sealing chamber 17 is obtained. The amount of water removed in 17 can be calculated according to Fanthof's law. An example of calculating the water removal amount in the sealed chamber 17 is shown in Table 1 below.

  Thus, the hypertonic solution concentration, the device capacity, and the device capacity and the volume of the sealing chamber are determined in advance so that the water removal amount in the sealing chamber 17 can be obtained in advance, and the drug D in the sealing chamber 17 can be concentrated to a desired concentration. And the volume of the enclosed chamber can be set respectively. For example, the amount of water removal can be controlled by changing the device capacity between 1 mL and 50 ML with respect to the volume of the sealed chamber.

Embodiment 2
As shown in FIG. 5, in the first embodiment, the auxiliary sealing that assists the sealing of the integrated balloon 2 by expanding the integrated balloon 2 behind the integrated balloon 2 disposed in the vicinity of the tip of the shaft 1 to seal the blood vessel. A new balloon 21 can also be arranged. An expansion liquid hub 22 for supplying an expansion liquid for expanding the auxiliary sealing balloon 21 is disposed at the proximal end portion of the shaft 1, and the expansion liquid is injected into the expansion liquid hub 22. A port 23 is formed for this purpose. Here, the expansion solution is not limited as long as the auxiliary sealing balloon 21 is expanded, and, for example, physiological saline or a contrast medium can be used.

As shown in FIG. 6, when the treatment device is inserted to the vicinity of the occlusion B while being guided by the guide wire 6, the drug D is supplied to the vicinity of the occlusion B and the hypertonic solution is supplied to the lumen for the expansion liquid. 13 is supplied into the integrated balloon 2 through the opening 12 of the shaft 1. Further, the expansion liquid is injected from the port 23 of the expansion liquid hub 22, and enters the auxiliary sealing balloon 21 from the opening 25 via the expansion liquid lumen 24 connected to the expansion liquid hub 22 in the shaft 1. Supplied. As described above, the hypertonic solution and the expansion solution are supplied to the integrated balloon 2 and the auxiliary sealing balloon 21, respectively, so that the integrated balloon 2 and the auxiliary sealing balloon 21 are expanded until the outer peripheral portions abut against the blood vessel wall. Is done.
In the expanded integrated balloon 2, the rear portion 14 seals the back of the blood vessel V and forms a sealing chamber 17 between the closed portion B and the front portion. On the other hand, the expanded auxiliary sealing balloon 21 suppresses the blood in the blood vessel V from flowing from the rear portion 26 side to the front portion 27 side, and seals the blood vessel V in front of the integrated balloon 2. Thereby, the blood vessel V is blocked by the auxiliary sealing balloon 21 by the rear portion 14 of the integrated balloon 2, and blood can be prevented from flowing into the sealing chamber 17 more strongly.

A semipermeable membrane 16 disposed in the front portion 15 of the integrated balloon 2 is exposed in the sealed chamber 17, and the blood in the sealed chamber 17 and the blood in the integrated balloon 2 are separated from the semipermeable membrane. There is an osmotic pressure difference with the hypertonic solution. For this reason, the water component W contained in the blood in the sealed chamber 17 is sucked into the integrated balloon 2 through the semipermeable membrane 16 by osmotic pressure.
At this time, since the inflow of blood into the sealing chamber 17 is strongly suppressed by the auxiliary sealing balloon 21, the water component W in the sealing chamber 17 can be reduced efficiently, and the inside of the sealing chamber 17 The concentration rate of the drug D confined in can be further improved.

  According to the present embodiment, the drug D can be concentrated to a higher concentration in the sealed chamber 17 by strongly suppressing the inflow of blood into the sealed chamber 17. The effect of action can be further enhanced.

In the present embodiment, as shown in FIG. 7, a water removal balloon 28 can be arranged in place of the integrated balloon 2 and a sealing balloon 29 can be arranged in place of the auxiliary sealing balloon 21. This water removal balloon 28 is a balloon dedicated to water removal that absorbs the water component W contained in the blood. Liquid is supplied. When the hypertonic solution is supplied to the inside, the dewatering balloon 28 is expanded, but it is not necessary to expand until the outer peripheral portion comes into contact with the blood vessel wall. Expansion of the balloon 28 is stopped.
On the other hand, the sealing balloon 29 is a dedicated balloon for sealing the inside of the blood vessel. When the expansion liquid is supplied into the inside via the expansion liquid lumen 24, the sealing balloon 29 is expanded until the outer peripheral portion comes into contact with the blood vessel wall. Block back. In this way, the expansion of the sealing balloon 29 suppresses the inflow of blood from the rear part 26 side to the front part 27 side of the sealing balloon 29, and is positioned in front of the sealing balloon 29 and the water removal balloon 28. A sealing chamber 30 is formed between the closed portion B to be closed.

The semipermeable membrane 16 disposed on the entire outer peripheral portion of the water removal balloon 28 is exposed in the thus formed sealing chamber 30, and the semipermeable membrane is separated from the inside of the sealing chamber 30. There is an osmotic pressure difference between the blood and the hypertonic solution in the water removal balloon 28. For this reason, the water component W contained in the blood in the sealed chamber 30 is sucked into the dewatering balloon 28 through the semipermeable membrane 16 by osmotic pressure. As the water component W in the sealed chamber 30 decreases, the drug D trapped in the sealed chamber 30 is concentrated, and the drug D effectively acts on the closed portion B exposed in the sealed chamber 30. be able to.
As described above, by separating the sealing balloon 29 dedicated to sealing and the dewatering balloon 28 dedicated to water removal, the range of the sealing chamber 30 can be freely changed.

Embodiment 3
FIG. 8 shows the configuration of a therapeutic device according to Embodiment 3 of the present invention. This therapeutic device includes a pair of sealing balloons 31 and 32 disposed in the vicinity of the distal end portion of the shaft 1, and a water removal balloon 33 disposed between the pair of sealing balloons 31 and 32. Have The sealing balloons 31 and 32 are dedicated balloons for sealing when the outer peripheral portion abuts against the blood vessel wall when expanded, and the blood vessel V is sealed. The dewatering balloon 33 has the semipermeable membrane 16 on the entire outer peripheral portion. It is a balloon dedicated to water removal that is disposed and sucks up the water component W contained in the blood.

Further, expansion fluid lumens 34 and 35 extending from the base end portion to the vicinity of the tip end portion are formed inside the shaft. The expansion liquid is injected into the expansion liquid lumen 34 from the proximal end portion of the shaft 1, and the injected expansion liquid is supplied into the sealing balloon 31 from the opening 36 a of the expansion liquid lumen 34 and is used for the expansion liquid. It is supplied into the sealing balloon 32 from the opening 36 b of the lumen 34. On the other hand, the hypertonic solution is injected into the expansion fluid lumen 35 from the proximal end portion of the shaft 1, and the injected hypertonic solution is supplied into the dewatering balloon 33 from the opening 37 of the expansion fluid lumen 35.
Here, the expansion solution is not limited as long as the auxiliary sealing balloon 21 is expanded, and, for example, physiological saline or a contrast medium can be used. As the hypertonic solution, one having an osmotic pressure higher than that of blood circulating in the blood vessel is used.

Next, the operation of the third embodiment will be described.
First, the therapeutic device is inserted to the vicinity of the stenosis part S generated so as to narrow the width of the blood vessel V, and the medicine D is supplied to the vicinity of the stenosis part S. Subsequently, when the expansion liquid is supplied to the sealing balloons 31 and 32 via the expansion liquid lumen 34, the sealing balloons 31 and 32 are expanded until the outer peripheral portions abut against the blood vessel wall, respectively. 31 seals the front of the blood vessel V and the sealing balloon 32 blocks the rear of the blood vessel V. As a result, a sealing chamber 38 in which the drug D is confined is formed between the sealing balloon 31 and the sealing balloon 32.

Thus, the semipermeable membrane 16 disposed on the entire outer peripheral portion of the water removal balloon 33 is exposed in the formed sealing chamber 38, and the sealing chamber 38 is separated from the semipermeable membrane 16. There is an osmotic pressure difference between the blood inside and the hypertonic solution in the water removal balloon 33. For this reason, the water component W contained in the blood in the sealed chamber 38 is sucked into the dewatering balloon 33 through the semipermeable membrane 16 by osmotic pressure.
As the water component W in the sealed chamber 38 decreases, the drug D trapped in the sealed chamber 38 is concentrated, and the drug D effectively acts on the constricted portion S exposed in the sealed chamber 38. be able to.

  According to the present embodiment, the sealing chamber 38 is formed by expanding the pair of sealing balloons 31 and 32, so that the sealing chamber 38 can be freely formed in the blood vessel V. For this reason, not only the treatment of the stenosis part S as described above but also the treatment of an injured part occurring in the blood vessel V can be widely applied only by changing the type of the drug D.

In the present embodiment, at least one of the pair of blocking balloons 31 and 32 may be formed as an integrated balloon configured integrally with the water removal balloon 33. This integrated balloon is expanded by supplying a hypertonic solution to the inside, the outer peripheral portion abuts against the blood vessel wall to form a sealed chamber, and a semipermeable membrane is disposed on the outer peripheral portion exposed in the sealed chamber. is there.
For example, as shown in FIG. 9, an integrated balloon 39 in which a blocking balloon 31 and a water removal balloon 33 are integrated can be disposed in front of the blocking balloon 32. The integrated balloon 39 is expanded until the outer peripheral portion comes into contact with the blood vessel wall by being supplied with the hypertonic liquid via the expansion liquid lumen 34 formed inside the shaft 1. As a result, the front portion 40 of the integrated balloon 39 blocks the front of the blood vessel V, and the blood in the blood vessel V is prevented from flowing from the front portion 40 side to the rear portion 41 side of the integrated balloon 39. On the other hand, the sealing balloon 32 is supplied with the expansion liquid via the expansion liquid lumen 35 formed inside the shaft 1 and expands until the outer peripheral portion comes into contact with the blood vessel wall. In this way, the front portion 40 of the integrated balloon 39 seals the front of the blood vessel V and the sealing balloon 32 seals the rear of the blood vessel V, so that a sealing chamber is provided between the integrated balloon 39 and the sealing balloon 32. 42 can be formed.

Thus, the semipermeable membrane 16 disposed in the rear portion 41 of the integrated balloon 39 is exposed in the formed sealing chamber 42, and the semipermeable membrane 16 is separated from the inside of the sealing chamber 42. There is an osmotic pressure difference between the blood and the hypertonic solution in the integrated balloon 39. For this reason, the water component W contained in the blood in the sealed chamber 42 is sucked into the integrated balloon 39 through the semipermeable membrane 16 by osmotic pressure.
As described above, by integrally forming the sealing balloon 31 and the dewatering balloon 33, the sealing chamber 42 can be formed narrowly, and the drug D confined and concentrated in the sealing chamber 42 is effective. Can act on the constriction S.

In the above first to third embodiments, the water component W in the sealed chamber is sucked up by the osmotic pressure difference generated between the blood in the blood vessel and the hypertonic solution in the balloon. However, the water component W in the sealed chamber is sucked up. It is not limited to this as long as it can be done.
For example, as shown in FIG. 10, in the treatment device of the third embodiment, a water removal lumen 51 extending from the proximal end to the vicinity of the distal end is formed inside the shaft 1 while removing the water removal balloon 33, A semipermeable membrane 52 can be disposed at the tip of the water removal lumen 51. Further, a water removal pump 53 is connected to the base end portion of the water removal lumen.

  The semipermeable membrane 52 disposed at the distal end portion of the water removal lumen 51 is exposed in the sealing chamber 38 formed by the pair of sealing balloons 31 and 32, and is semiconductive by the suction force of the water removal pump 53. The water component W in the sealed chamber 38 can be sucked through the permeable membrane 52. As a result, the drug D trapped in the sealed chamber 38 can be concentrated, and the drug can effectively act on the constricted portion S exposed in the sealed chamber 38.

Moreover, in said Embodiment 1-3, the water supply part which supplies a water | moisture content in a sealing chamber through the semipermeable membrane exposed in the sealing chamber can be further provided.
For example, as shown in FIG. 11, in the treatment device of the first embodiment, a water supply pump 54 is connected to the proximal end portion of the expansion fluid lumen 9, and the blood and the hypertonic solution are separated with the semipermeable membrane 16 interposed therebetween. Thus, a hypertonic solution or the like can be supplied into the integrated balloon 2 with a pressure larger than the osmotic pressure difference generated between the two. Thereby, the moisture W in the integrated balloon 2 moves against the osmotic pressure and is supplied into the sealed chamber 17 through the semipermeable membrane 16. Thus, by supplying the moisture W into the sealing chamber 17, for example, the drug D confined in the sealing chamber 17 is concentrated to act on the occlusion B in the blood vessel, and then concentrated in the sealing chamber 17. The drug D applied can be diluted. By diluting the drug D, the decomposition reaction of the blockage B can be stopped, and it is possible to suppress the burden on the living body due to the drug D acting more than necessary.

  In the first to third embodiments, the drug D is supplied into the sealed chamber via another catheter such as a microcatheter, a GW lumen, or the like. It is also possible to form a medicine lumen extending to the inside and supply the medicine D into the sealed chamber through this medicine lumen.

In the first to third embodiments, the therapeutic device is used for a lesion such as an obstruction occurring in a blood vessel. However, a living tube in which the inside of a bile duct, a urethra, etc. is filled with moisture. It can also be used for lesions in the cavity.
In the first to third embodiments, a so-called over-the-wire type balloon catheter in which a guide wire is inserted from the proximal end portion to the distal end portion is used as a therapeutic device. A so-called rapid exchange type balloon catheter in which a guide wire is passed only in the vicinity can also be used as a therapeutic device.

1 shaft, 2,39 integrated balloon, 3 GW hub, 4,22 expansion fluid hub, 5, 7, 23 port, 6 guide wire, 8 outer tube, 9 inner tube, 10, 12, 25, 36a, 36b, 37 opening, 11 GW lumen, 13, 24, 34, 35 expansion fluid lumen, 14, 26, 41 rear, 15, 27, 40 front, 16, 52 semipermeable membrane, 17, 30, 38 , 42 Sealing chamber, 21 Auxiliary sealing balloon, 28, 33 Water removal balloon, 29, 31, 32 Sealing balloon, 51 Water removal lumen, 53 Water removal pump, 54 Water supply pump, V blood vessel, B blockage part, S constriction, D drug, W water component.

Claims (10)

An elongate shaft for insertion into a body lumen;
A sealing balloon which is disposed in the vicinity of the distal end of the shaft so as to be expandable and expands so as to seal the vicinity of a lesion in a living body lumen filled with a water component to form a sealing chamber in the living body lumen;
A semi-permeable membrane that is exposed in the sealed chamber, and a water removal unit that concentrates a drug present in the sealed chamber by sucking a water component in the sealed chamber through the semi-permeable membrane. And therapeutic device.   The dewatering part has a dewatering balloon in which the semipermeable membrane is disposed on the outer peripheral part, and the dewatering balloon is disposed in the vicinity of the tip of the shaft and is supplied with a hypertonic solution therein. The therapeutic device according to claim 1, wherein water components in the sealed chamber are sucked into the inside through the semipermeable membrane by osmotic pressure. The sealing balloon and the dewatering balloon are integrally formed as an integrated balloon,
The integrated balloon has the semipermeable membrane disposed at the front and expanded by being supplied with the hypertonic solution therein, and when expanded, the rear part comes into contact with the body lumen and seals the rear. The therapeutic device according to claim 2, wherein the sealed chamber is formed with a lesion located in front.   The therapeutic device according to claim 3, further comprising an auxiliary sealing balloon that is disposed behind the integrated balloon, expands to seal a living body lumen, and assists the sealing with the integrated balloon. The dewatering balloon is disposed in front of the blocking balloon and the semipermeable membrane is disposed over the entire outer periphery,
The said blocking balloon forms the said sealing chamber between the lesioned part located ahead of the said dewatering balloon by expanding so that it may contact | abut to a biological lumen, and sealing back. The therapeutic device as described. The sealing balloon is composed of a pair of sealing balloons, and forms the sealing chamber by expanding the pair of sealing balloons so as to contact the living body lumen.
At least one of the pair of sealing balloons is formed as an integrated balloon configured integrally with the dewatering balloon, and the semipermeable membrane is disposed on an outer peripheral portion exposed in the sealing chamber of the integrated balloon. The therapeutic device according to claim 2. The shaft has a water removal lumen extending from the proximal end portion to the vicinity of the distal end portion, and the semipermeable membrane is disposed at a distal end portion of the water removal lumen,
The dewatering part has the dewatering pump connected to the base end of the dewatering lumen, and sucks out water components in the sealed chamber through the semipermeable membrane by the suction force of the dewatering pump. The therapeutic device according to claim 1. The shaft has a drug lumen extending from the proximal end portion to the vicinity of the distal end portion,
The therapeutic device according to any one of claims 1 to 7, wherein the drug is supplied into the sealed chamber through the drug lumen. Inserting the therapeutic device according to any one of claims 1 to 8 into a biological lumen;
By expanding the sealing balloon, a sealing chamber is formed in the vicinity of the lesion in the living body lumen,
A method of using a therapeutic device, comprising: concentrating a drug present in the sealed chamber by sucking a water component in the sealed chamber through the semipermeable membrane.   The drug concentrated in the sealed chamber is diluted by supplying water into the sealed chamber through the semipermeable membrane after the drug is concentrated by sucking out water components in the sealed chamber. How to use your therapeutic device.