JP6833429B2 - Medical device surface attachment device - Google Patents

Description

The present invention relates to a medical device surface attachment device that attaches a drug or the like to the surface of a medical device such as a balloon that expands in the lumen of a living body.

Balloon catheters are widely used as medical devices for improving lesions (stenosis) that occur in the lumen of a living body. Balloon catheters typically include a long shaft and a radially expandable balloon on the tip of the shaft that allows the contracted balloon to pass through the narrow biological lumen into the body. The lesion can be expanded by expanding the balloon after reaching the destination.

On the other hand, when the lesion is forcibly expanded by a balloon, endothelial cells may proliferate excessively and develop new stenosis (restenosis) in the lesion. For this reason, a drug-coated balloon (DCB) in which the outer surface of the balloon is coated with a drug for suppressing stenosis may be used. By expanding the drug application balloon, the drug coated on the outer surface can be released to the lesion portion and the drug can be transferred to the living tissue, whereby restenosis can be suppressed.

In addition, in the treatment of myocardial infarction and angina, a method of indwelling a stent (living object) in a lesion (stenosis) of a coronary artery to secure a space in the coronary artery is performed, and other blood vessels, Similar methods may be used to improve strictures formed in the bile ducts, trachea, esophagus, urinary tract, and other living lumens. Also in treatment with a stent, a drug-eluting stent whose surface is coated with a drug for suppressing stenosis may be used.

As described above, in a medical device having a substance such as a drug on the surface, it is necessary to prevent the substance having the surface from falling off until the medical device is delivered to the lesion. For example, in Patent Document 1, a drug-containing material is provided on the inner surface of the tip of an accommodating portion for accommodating a self-expandable stent, and when the stent is released from the accommodating portion, the drug-containing material is attached to the outer surface of the stent. I have to. As a result, since the drug is provided on the surface of the stent after the stent is delivered to the lesion portion, it is possible to prevent the stent from falling off during delivery.

International Publication No. 2014/162400

Although the invention of Patent Document 1 can attach a drug to a self-expandable stent, it cannot be directly applied to other medical devices such as a drug application balloon. Further, as the substance to be attached to the surface of the medical device, there are various substances such as a lubricating coat and a gel for protecting the drug as well as the drug. Therefore, there is a demand for an instrument capable of easily adhering a necessary substance to the surface of various types of medical devices.

The present invention has been made to solve the above-mentioned problems, and provides a medical device surface attachment device capable of easily attaching a necessary substance to the surface of various types of medical devices. The purpose is.

The medical device surface attachment device according to the present invention that achieves the above object is a medical device surface attachment device provided on the proximal end side of a port portion that guides the medical device to the biological lumen.
It has a storage unit that holds the adhering substance to be attached to the surface of the medical device.
The storage portion has an inlet opening for inserting the medical device inside and an outlet opening for communicating with the port portion.
The adhering substance is stored in the storage portion so as to be able to adhere to the surface of the medical device passing from the inlet opening toward the outlet opening.
The adhering substance stored in the storage portion is held in the porous body and is held.
The porous body, an inner diameter contacts the large diameter portion of the medical device has, and have a communication hole having an inner diameter larger than the outer diameter of the portion other than the large-diameter portion of said medical device,
The storage portion has an adhesion amount adjusting portion at the outlet opening, and the adhesion amount adjusting portion adjusts the adhered substance adhering to the surface of the medical device that has passed through the storage portion to a predetermined thickness .

The medical device surface attachment device configured as described above can attach substances to the surface by inserting the medical device through the entrance opening, so that various substances can be easily applied to the surface of the medical device. Can be attached to.

If the adhering substance stored in the storage portion is in the form of a gel, the adhering substance can be prevented from leaking from the storage portion.

If the adhering substance stored in the storage portion is held by the porous body, it is possible to prevent the adhering substance from leaking from the storage portion even if the adhering substance has a low viscosity.

The storage portion has an adhesion amount adjusting portion at the outlet opening, and the adhesion amount adjusting portion adjusts the adhered substance adhering to the surface of the medical device that has passed through the storage portion to a predetermined thickness. Therefore, the amount of the adhering substance on the surface of the medical device can be appropriately adjusted.

The storage portion has a check valve at the inlet opening. Therefore, it is possible to prevent the adhering substance from leaking from the inlet opening.

If the storage portion has a deformable wall that deforms so as to change the volume inside the storage portion, the deformable wall is deformed to increase the pressure inside the storage portion and adhere to the storage portion. The substance can be attached by the medical device, and even when the attached substance is reduced, the attached substance can be surely attached to the surface of the medical device.

The storage portion has a partition wall portion that moves so as to change the internal volume for storing the adhering substance, and the partition wall portion is urged in a direction of reducing the internal volume for storing the adhering substance. By doing so, the volume of the storage portion is reduced as the amount of adhering substances is reduced, and the pressure inside the storage portion can be maintained at a constant level.

If a plurality of the storage portions are provided in series, a plurality of types of adhering substances can be adhered to the surface as the medical device passes through.

It is a front view of the state which attached the medical device surface attachment device of 1st form to the port member of a guiding catheter. It is sectional drawing of the medical device surface attachment device of 1st form. It is the whole front view of the balloon catheter. It is an enlarged sectional view near the tip of a balloon catheter. It is sectional drawing of the state which inserted the balloon catheter into the medical device surface attachment device. It is sectional drawing of the state which attached the medical device surface attachment device of 2nd form to a port member. It is sectional drawing of the medical device surface attachment device of 3rd form. It is sectional drawing of the medical device surface attachment device of 4th form. It is sectional drawing of the medical device surface attachment device of 5th form. It is sectional drawing of the medical device surface attachment device of 6th form.

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 where the catheter is inserted into the biological lumen 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 medical device surface attachment device 1 of the first form is provided at the proximal end portion of the guiding catheter 2 that guides the medical device into the living lumen, and is used for adhering an adherent substance to the surface of the medical device. In this embodiment, the medical device is a balloon catheter. As shown in FIG. 1, the guiding catheter 2 has a long shaft 20 inserted into a living lumen and a port member 21 provided at a proximal end portion of the shaft 20. The port member 21 has a port portion 22 at the base end, which is an inlet of the medical device, and the medical device surface attachment device 1 is attached to the port portion 22.

As shown in FIG. 2, the medical device surface attachment device 1 engages with a storage portion 10 for accommodating a gel-like adhering substance 13 containing a drug to be attached to the surface of a balloon of a balloon catheter and a port portion 22. It has a port fixing portion 14 to be fixed. The medical device surface attachment device 1 is formed of a hard resin or the like. The storage portion 10 has an entrance opening 11 that serves as an entrance for the medical device and an outlet opening 12 that serves as the exit for the medical device. The outlet opening 12 communicates with the lumen of the port 22, and a medical device inserted into the storage 10 through the inlet 11 can be guided from the port 22 into the guiding catheter 2.

The inlet opening 11 is provided with a check valve portion 11a so that the adhering substance 13 in the storage portion 10 does not leak to the outside. Further, the outlet opening 12 is provided with an adhesion amount adjusting portion 12a for adjusting the thickness of the adhering substance 13 adhering to the surface of the medical device that has passed through the storage portion 10. The adhesion amount adjusting portion 12a is formed in a tapered shape that reduces the diameter of the outlet opening 12 along the insertion direction, and the adhered substance 13 adhering to the surface of the medical device is removed to a predetermined thickness.

The balloon catheter 30 which is a medical device will be described. As shown in FIG. 3, the balloon catheter 30 includes a long balloon catheter shaft 31, a balloon 32 provided at the tip of the balloon catheter shaft 31, and a hub 33 provided at the base end of the balloon catheter shaft 31. have. As shown in FIG. 4, in the balloon catheter shaft 31, the outer tube 35 and the inner tube 36, which are formed in a long hollow shape, are arranged concentrically. The inner diameter of the outer pipe 35 is larger than the outer diameter of the inner pipe 36, and the inner pipe 36 is housed in the hollow inside of the outer pipe 35. The hollow interior of the inner tube 36 forms a guide wire lumen 38 through which the guide wire 34 is inserted. Further, an expansion lumen 37 for circulating the expansion fluid of the balloon 32 is formed inside the hollow inside of the outer tube 35 and outside the inner tube 36.

The guide wire 34 is inserted into the guide wire lumen 38 through the opening 31a at an intermediate position in the axial direction of the balloon catheter shaft 31. The inner pipe 36 is provided only on the tip side of the opening 31a. The balloon catheter 30 is a so-called rapid exchange type catheter.

The inner pipe 36 projects further to the tip side than the tip of the outer pipe 35. The base end side end of the balloon 32 is fixed to the tip end of the outer tube 35, and the tip end side end is fixed to the tip end of the inner tube 36. As a result, the inside of the balloon 32 communicates with the expansion lumen 37. The balloon 32 is expanded by injecting an expansion fluid through the expansion lumen 37. The expansion fluid may be a gas or a liquid, and for example, a gas such as helium gas, CO ₂ gas, or O ₂ gas, or a liquid such as physiological saline or a contrast medium can be used.

The outer tube 35 and the inner tube 36 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. Further, the balloon 32 is made of a flexible material like the outer tube 35 and the inner tube 36.

When such a balloon catheter 30 is inserted into the living lumen, the guiding catheter 2 is inserted into the living lumen in advance, and the balloon catheter 30 is inserted from the port member 21 of the guiding catheter 2. At this time, the balloon catheter 30 passes through the medical device surface attachment device 1 provided at the proximal end portion of the port member 21.

As shown in FIG. 5, the adhering substance 13 in the storage portion 10 comes into contact with the surface of the balloon 32 of the balloon catheter 30 inserted into the storage portion 10 from the inlet opening 11. As a result, the adhering substance 13 adheres to the surface of the balloon 32. In the balloon 32 that has passed through the storage portion 10, excess adhering substance 13 is removed by the adhering amount adjusting portion 12a of the outlet opening 12. The port member 21 has a valve portion 23 for preventing backflow of blood in the lumen, and the balloon 32 is guided into the biological lumen through the valve portion 23.

In this way, the medical device surface attachment device 1 is provided in the port portion 22, and the balloon 32 of the balloon catheter 30 passes through the storage portion 10 in which the adhering substance 13 is stored, so that the surface of the balloon 32 contains the drug. Adherent substance 13 can be attached. That is, since the drug can be easily attached to the surface of the balloon 32 simply by passing the medical device surface attachment device 1 through the balloon 32, the workability in the procedure for delivering the balloon 32 having the drug to the lesion portion is good. Can be.

Next, the medical device surface attachment device 40 of the second form will be described. As shown in FIG. 6, the medical device surface attachment device 40 of the present embodiment has a storage portion 41 for storing a gel-like adhering substance 44, and the storage portion 41 has an inlet opening 42 and an outlet opening 43. In that respect, it is similar to the medical device surface attachment device 1 of the first form.

The medical device surface attachment device 40 of this embodiment has a port fixing portion 45 that is inserted into the lumen of the port portion 22. The port fixing portion 45 has an outer diameter that matches the inner diameter of the port member 21, and is formed in a tubular shape having an inner diameter through which a balloon catheter can be inserted. Further, the port fixing portion 45 is inserted from the port portion 22 to the tip end side of the valve portion 23. In this way, the medical device surface attachment device 40 may be fixed in the lumen of the port member 21.

Next, the medical device surface attachment device 50 of the third form will be described. As shown in FIG. 7, the medical device surface attachment device 50 of the present embodiment has a storage portion 51 for storing a gel-like adhering substance 54 and a port fixing portion 55 for engaging and fixing with respect to the port portion 22. However, the storage portion 51 is similar to the medical device surface attachment device 1 of the first embodiment in that it has an inlet opening 52 and an outlet opening 53.

In the medical device surface attachment device 50 of the present embodiment, a part of the wall surface of the storage portion 51 can be deformed. Specifically, the upper and lower surfaces of the storage portion 51 are each deformable wall 51a formed of a flexible material, and the volume inside the storage portion 51 can be changed by pressing the deformable wall 51a.

When the deformable wall 51a is pressed to reduce the volume inside the storage portion 51, the pressure of the adhering substance 54 in the storage portion 51 increases, and the adhering substance 54 can be easily adhered to the surface of the balloon 32. Further, even when the balloon catheter passes through the medical device surface attachment device 50 many times and the amount of the adhered substance 54 in the storage portion 51 decreases, the deformable wall 51a is pressed to reduce the volume in the storage portion 51. By reducing the size of the balloon 32, the adhering substance 54 can be attached to the surface of the balloon 32. Even when the deformable wall 51a is pressed to increase the pressure of the adhering substance 54 in the storage portion 51, the check valve 52a is provided in the inlet opening 52, so that the adhering substance 54 is provided. Leakage is prevented.

Next, the medical device surface attachment device 60 of the fourth form will be described. As shown in FIG. 8, the medical device surface attachment device 60 of the present embodiment has a storage portion 61 for storing a gel-like adhering substance 64 and a port fixing portion 65 for engaging and fixing with respect to the port portion 22. However, the storage portion 61 is similar to the medical device surface attachment device 1 of the first embodiment in that it has an inlet opening 62 and an outlet opening 63.

The medical device surface attachment device 60 of the present embodiment has two partition walls 66 in the storage portion 61, and the adhering substance 64 is stored between the two partition walls 66. Each partition wall 66 is urged by the urging portion 67 in a direction of reducing the volume of the portion accommodating the adhering substance 64. Therefore, when the adhering substance 64 decreases, the volume between the partition walls 66 decreases accordingly, and the pressure of the adhering substance 64 is kept constant. As a result, even if the amount of the adhering substance 64 in the storage portion 61 is reduced, the adhering substance 64 can be attached to the surface of the balloon 32. In this embodiment, two partition walls 66 are provided so as to face each other in the storage section 61, but one may be used.

Next, the medical device surface attachment device 70 of the fifth form will be described. As shown in FIG. 9, the medical device surface attachment device 70 of the present embodiment has a storage portion 71 for storing adhered substances and a port fixing portion 75 for engaging and fixing with respect to the port portion 22. 71 is similar to the medical device surface attachment device 1 of the first embodiment in that it has an inlet opening 72 and an outlet opening 73.

In the medical device surface adhesion device 70 of the present embodiment, the adhering substance stored in the storage portion 71 is held by a porous body 74 such as a sponge. The porous body 74 has a communication hole 74a that allows the inlet opening 72 and the outlet opening 73 to communicate with each other. The balloon catheter 30 inserted through the entrance opening 72 passes through the communication hole 74a. The communication hole 74a is formed to have a diameter that allows it to come into contact with the surface of the passing balloon 32, and an adhering substance can be attached to the surface of the balloon 32.

By holding the adhered substance in the porous body 74 in this way, even an adherent substance having a low viscosity can be stored in the storage portion 71 and prevented from leaking. Further, of the balloon catheter 30, only the portion of the balloon 32 having a large diameter comes into contact with the communication hole 74a of the porous body 74, so that it is possible to prevent the adhering substance from adhering to the balloon catheter shaft 31.

Next, the medical device surface attachment device 80 of the sixth form will be described. As shown in FIG. 10, in the medical device surface attachment device 80 of this embodiment, the first storage portion 81, the second storage portion 82, and the third storage portion 83 are arranged in series. The first adhering substance 87 is stored in the first storage portion 81, the second adhering substance 88 is stored in the second storage portion 82, and the third adhering substance 89 is stored in the third storage portion 83. Is stored.

The first storage portion 81 on the most proximal side of the medical device surface attachment device 80 has an inlet opening 84 into which the balloon catheter 30 is inserted. The third storage portion 83 on the most distal side of the medical device surface attachment device 80 has an outlet opening 85 that communicates with the lumen of the port portion 22. Further, the first storage unit 81 and the second storage unit 82, and the second storage unit 82 and the third storage unit 83 are communicated with each other by the communication unit 86.

The balloon catheter 30 inserted into the first storage portion 81 from the entrance opening 84 passes through the second storage portion 82 and the third storage portion 83 via the communication portion 86, and from the outlet opening 85 to the port portion 22. Be guided. At this time, the first adhering substance 87 is adhered to the surface of the balloon 32 at the first accommodating portion 81, the second adhering substance 88 is adhered to the surface of the second accommodating portion 82, and the third adhering substance 88 is attached to the surface thereof. The third adhering substance 89 is adhering to the accommodating portion 83. That is, each adhering substance is adhered to the balloon 32 in a layered manner.

By providing the storage portions in series in this way, a plurality of different substances can be attached to the surface of the medical device at once. The number of storage units provided in series is three in this embodiment, but may be two or four or more.

As described above, the medical device surface attachment device 1 according to the present embodiment is the medical device surface attachment device 1 provided on the proximal end side of the port portion 22 that guides the medical device to the biological lumen, and is the surface of the medical device. The storage unit 10 has a storage unit 10 for holding the adhering substance 13 to be adhered to the medical device, and the storage unit 10 has an inlet opening 11 for inserting the medical device inside and an outlet opening 12 communicating with the port 22. The substance 13 is stored in the storage unit 10 so as to be able to adhere to the surface of the medical device passing from the inlet opening 11 toward the outlet opening 12. As a result, the adhering substance 13 can be adhered to the surface by inserting the medical device from the entrance opening 11, so that various substances can be easily adhered to the surface of the medical device.

Further, if the adhering substance 13 stored in the accommodating portion 10 is in the form of a gel, the adhering substance 13 can be prevented from leaking from the accommodating portion 10.

Further, if the adherent substance 74 stored in the storage portion 71 is held by the porous body 74, the adherent substance 74 does not leak from the storage portion 71 even if the adherent substance 74 has a low viscosity. Can be done.

Further, the storage unit 10 has an adhesion amount adjusting unit 12a at the outlet opening 12, and the adhesion amount adjusting unit 12a adjusts the adhered substance 13 adhering to the surface of the medical device that has passed through the storage unit 10 to a predetermined thickness. .. Therefore, the amount of the adhering substance 13 on the surface of the medical device can be appropriately adjusted.

Further, the storage portion 10 has a check valve 11a at the inlet opening 11. Therefore, it is possible to prevent the adhered substance 13 from leaking from the inlet opening 11.

Further, if the storage portion 50 has a deformable wall 51a that is deformed so as to change the internal volume for storing the adhering substance 54, the pressure inside the storage portion 51 can be obtained by deforming the deformable wall 51a. Can be increased, and the adhering substance 54 can be adhered to the surface of the medical device even when the adhering substance 54 is reduced.

Further, the storage portion 60 has a partition wall portion 66 that moves so as to change the internal volume of accommodating the adhering substance 64, and the partition wall portion 66 is urged in a direction of reducing the internal volume of accommodating the adhering substance 64. If this is done, the volume of the storage portion 61 will decrease as the amount of the adhering substance 64 decreases, and the pressure inside the storage portion 61 can be maintained at a constant level.

Further, if a plurality of the storage portions 80 are provided in series, a plurality of types of adhering substances can be adhered to the surface as the medical device passes through.

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. For example, in the above embodiment, the medical device to which the adhering substance is attached is a balloon catheter, but the medical device may be another type such as a catheter or a guide wire for delivering the stent to the lesion.

In addition to the drug, the adhering substance to be attached to the medical device may be another type such as a gel or a lubricating coat for protecting the surface of the medical device. Further, when the gel-like adhering substance is stored in the storage portion, the amount of gel adhering to the surface of the medical device can be adjusted by adjusting the viscosity of the gel.

1 Medical device surface attachment device 2 Guiding catheter 10 Storage part 11 Inlet opening 11a Check valve part 12 Outlet opening 12a Adhesion amount adjustment part 13 Adhesive substance 14 Port fixing part 20 Shaft 21 Port member 22 Port part 23 Valve part 30 Balloon catheter 31 Balloon catheter shaft 32 Balloon 33 Hub 34 Guide wire

Claims (6)

A medical device surface attachment device provided on the base end side of a port portion that guides a medical device to a biological lumen.
It has a storage unit that holds the adhering substance to be attached to the surface of the medical device.
The storage portion has an inlet opening for inserting the medical device inside and an outlet opening for communicating with the port portion.
The adhering substance is stored in the storage portion so as to be able to adhere to the surface of the medical device passing from the inlet opening toward the outlet opening.
The adhering substance stored in the storage portion is held in the porous body and is held.
The porous body, an inner diameter contacts the large diameter portion of the medical device has, and have a communication hole having an inner diameter larger than the outer diameter of the portion other than the large-diameter portion of said medical device,
The storage portion has an adhesion amount adjusting portion at the outlet opening, and the adhesion amount adjusting portion adjusts the adhered substance adhering to the surface of the medical device that has passed through the storage portion to a predetermined thickness. Adhesive device. The medical device surface-adhering device according to claim 1, wherein the adhering substance stored in the storage portion is in the form of a gel. The medical device surface attachment device according to claim 1 or 2 , wherein the storage portion has a check valve at the inlet opening. The medical device surface-adhering device according to any one of claims 1 to 3 , wherein the accommodating portion has a deformable wall that deforms so as to change the internal volume for accommodating the adhering substance. The storage portion has a partition wall portion that moves so as to change the internal volume for storing the adhering substance, and the partition wall portion is urged in a direction of reducing the internal volume for storing the adhering substance. The medical device surface attachment device according to any one of claims 1 to 3. The medical device surface attachment device according to any one of claims 1 to 5 , wherein a plurality of the storage portions are provided in series.

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