WO2019182131A1

WO2019182131A1 - Medical device and method of applying medicament

Info

Publication number: WO2019182131A1
Application number: PCT/JP2019/012162
Authority: WO
Inventors: ともみ井上; 隆熊澤; 雄紀坂口; 太輝人犬飼; 和俊大橋
Original assignee: テルモ株式会社
Priority date: 2018-03-23
Filing date: 2019-03-22
Publication date: 2019-09-26
Also published as: JP7214715B2; JPWO2019182131A1

Abstract

[Problem] To provide a medical device and a method of applying a medicament which are capable of preventing a medicament from being removed while delivering the medicament to a target site in a body lumen and of selectively applying the medicament to the target site by a simple procedure. [Solution] A medical device 10 that includes: a catheter 100 which has a long body portion 110 that includes an inner wall portion 121 that forms a lumen 111, an outer wall portion 123 that forms an outer surface, a medicament retaining portion 125 that is provided between the inner wall portion 121 and the outer wall portion 123 and is capable of retaining a medicament 130 to be released inside a blood vessel B, and a medicament releasing portion 127 that is formed on the outer wall portion and is capable of releasing the medicament from the medicament retaining portion toward the outer surface; and a balloon catheter 200 that initiates release of the medicament from the medicament releasing portion by applying energy to the body portion of the catheter.

Description

Medical device and method of applying drug

The present invention relates to a medical device for applying a drug and a method for applying the drug.

Conventionally, a drug-coated balloon catheter used for applying a drug to a target site in a living body is known (for example, see Patent Document 1).

The drug-coated balloon catheter includes a long shaft and a balloon disposed at the tip of the shaft, and a drug is carried (held) on the outer surface of the balloon. A surgeon such as a doctor delivers a balloon to a target site in the living body (for example, a treatment site of a biological lumen such as a blood vessel), and applies the drug to the blood vessel wall or the like by expanding the balloon at the target site. Take action.

JP 2013-192755 A

However, in the treatment using the drug-coated balloon catheter, for example, the following problems can occur.

In a drug-coated balloon, when the balloon is expanded, the drug is applied to the site that comes into contact with the outer surface of the balloon. There is a possibility of being applied.

Also, while the drug-coated balloon catheter is being delivered to the target site, the drug may fall off from the outer surface of the balloon, and the therapeutic effect of the drug may be reduced.

Also, in treatment using a drug coated balloon catheter, the amount of drug that can be applied in one treatment depends on the balloon length. Therefore, when the target site exists over a relatively wide range (for example, a relatively long range in the extending direction of the body lumen), it is necessary to perform a plurality of treatments using a plurality of drug-coating balloon catheters. is there. Therefore, the work burden required for the procedure is applied and the medical economy is reduced.

Also, depending on the properties of the drug (for example, when the drug is a liquid or has a high viscosity), it may be difficult to coat the drug on the balloon. In such a case, it is necessary to give up application of the drug by the drug coating balloon catheter. However, depending on the target site, it may be difficult to eject the medicine (injection), so it may be necessary to abandon the application of the medicine itself.

There is also a demand for applying a drug to a target site prophylactically by a simple procedure (procedure) regardless of the use of a drug-coated balloon catheter.

The present invention has been made in view of the above problems, and can prevent the drug from dropping during delivery of the drug to the target site in the living body lumen, and the drug to the target site by a simple treatment. It is an object of the present invention to provide a medical device capable of selectively applying a drug and a method for applying a drug.

A medical device according to the present invention is provided between an inner wall portion that forms a lumen, an outer wall portion that forms an outer surface, and the inner wall portion and the outer wall portion, and holds a drug that is released in a living body lumen. An elongate member comprising a body part having a possible drug holding part, a drug release part formed on the outer wall part and capable of releasing the drug from the drug holding part to the outer surface side, and the drug release part An energy application unit that starts the release of the drug from the drug release unit by applying energy thereto.

In addition, the method for applying a medicine according to the present invention includes a step of providing a long member including a long main body portion in a state in which the medicine is held in a medicine holding portion provided between the inner wall portion and the outer wall portion; A step of preparing an energy applying unit capable of applying energy for starting the release of the drug from the drug holding unit, a step of introducing the main body into a body lumen, and a step of introducing the main body into the living body. In the state introduced into the lumen, the energy application unit selectively applies energy to an arbitrary position of the main body unit to release the drug from the drug holding unit, and the biological tube Applying the medicine to the application target portion of the cavity.

According to the medical device and the method of applying the drug, it is possible to prevent the drug from dropping out while delivering the drug to the target site in the living body lumen, and to select the drug for the target site by a simple treatment. It becomes possible to apply it.

It is a figure which shows the medical device which concerns on embodiment. It is sectional drawing which shows the main-body part of the elongate member which concerns on embodiment. FIG. 3 is a cross-sectional view taken along arrows 3A-3A in FIG. It is a flowchart which shows each procedure of the coating method of the chemical | medical agent which concerns on embodiment. FIGS. 5A to 5C are cross-sectional views schematically showing each procedure of the drug application method. 6 (A) to 6 (C) are cross-sectional views schematically showing each procedure of the method of applying a medicine. It is sectional drawing which shows the modification 1 of embodiment. FIG. 8 is a sectional view taken along arrows 8A-8A in FIG. FIG. 9A and FIG. 9B are cross-sectional views for explaining a second modification of the embodiment. FIG. 10A and FIG. 10B are cross-sectional views for explaining a third modification of the embodiment. It is sectional drawing for demonstrating the modification 4 of embodiment. It is sectional drawing for demonstrating the modification 5 of embodiment. It is a perspective view for demonstrating the modification 6 of embodiment. It is sectional drawing for demonstrating the modification 6 of embodiment.

Hereinafter, embodiments of the present invention will be described with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio.

As shown in FIG. 1, the medical device 10 according to the present embodiment includes a catheter 100 (corresponding to “long member”) and a balloon catheter 200 (corresponding to “energy applying unit”).

As shown in FIGS. 5 (A) to (C) and FIGS. 6 (A) to (C), the medical device 10 has a predetermined target site (application of a drug) in a blood vessel (corresponding to “biological lumen”) B. It is configured as a device for applying the drug 130 to the target site. The living body lumen to which the drug is applied is not limited to blood vessels, and may be, for example, the bile duct, trachea, esophagus, other gastrointestinal tract, urethra, ear and nose lumen, and preferably coronary artery or lower limb artery It is.

(catheter)
The catheter 100 includes a long main body 110 having flexibility, and a hub 140 disposed on the proximal end side of the main body 110. In the description of the present specification, the side of the catheter 100 that is introduced into the living body is referred to as the “front end side”, the side on which the hub 140 is disposed is referred to as the “base end side”, and the direction in which the main body 110 extends. (The left-right direction in FIG. 1) is referred to as an “axial direction”.

FIG. 2 shows a cross-sectional view (longitudinal cross-sectional view) near the tip of the main body 110. FIG. 3 shows a cross-sectional view (transverse cross-sectional view) of a portion indicated by arrows 3A-3A in FIG.

The main body 110 of the catheter 100 is formed of a hollow tubular member.

As shown in FIGS. 2 and 3, the main body 110 of the catheter 100 includes an inner wall 121 that forms the lumen 111, an outer wall 123 that forms the outer surface of the main body 110, an inner wall 121 and an outer wall 123. And a drug holding part 125 that can hold the drug 130 released in the blood vessel B, and a drug release part that is formed on the outer wall part 123 and that can release the drug 130 from the drug holding part 125 to the outer surface side. 127.

At the distal end of the main body 110 of the catheter 100, a distal end opening 112 that communicates the lumen 111 with the outside is formed.

The medicine holding part 125 is configured by a space part that extends along the axial direction of the main body part 110 and is formed between the inner wall part 121 and the outer wall part 123. The medicine holding part 125 is closed at the tip of the main body part 110.

The range (length in the axial direction) in which the medicine holding part 125 is formed in the axial direction of the main body 110 is not particularly limited. For example, a plurality of drug holding portions 125 may be provided at arbitrary positions in the axial direction of the main body 110 in a state where they are not in communication with each other. Moreover, the thickness (thickness on the cross section) of the medicine holding part 125 is not particularly limited.

The drug release part 127 is configured by a through hole formed in the outer wall part 123 so as to communicate the drug holding part 125 and the outer surface of the main body part 110. For example, the through hole may be formed over the entire circumference of the main body 110 or may be formed only in a part of the circumferential direction. Further, the cross-sectional shape and the number of through-holes constituting the medicine discharge portion 127, the interval between the through-holes in the axial direction of the main body 110, etc. are not particularly limited.

In addition, when the medicine discharge | release part 127 is comprised with a through-hole, it is preferable that the diameter (hole diameter) of a through-hole is more than the molecular size of the chemical | medical agent to apply | coat and 100 micrometers or less, for example. The reason why such a dimension example is preferable is as follows. If the diameter of the through hole is excessively large, the medicine may be released from the through hole in a state where energy is not applied by the energy application unit 200. Further, if the diameter of the through hole is excessively small, it may be difficult to smoothly release the drug 130 through the through hole. However, the specific dimension of the diameter of the through hole is not particularly limited as long as the drug 130 can be released when energy is applied by the energy application unit 200.

The specific configuration of the drug release unit 127 according to the present embodiment is not limited as long as the drug 130 can be released from the drug holding unit 125 to the outside as the balloon 210 is expanded. For example, the drug release part 127 may be configured by a mesh shape in which a small hole is formed, a semipermeable membrane that allows only the drug 130 to pass through, a rupture part (fragile part) that breaks when the balloon 210 is expanded, and the like. Is possible.

When the balloon 210 is expanded in the lumen 111 (see FIGS. 5C and 6B), the main body 110 deforms the inner wall 121 and the outer wall 123 and holds them in the medicine holding part 125. It is preferable to have a predetermined flexibility so that the drug 130 can be released from the drug release portion 127. From this point of view, the main body 110 (inner wall 121 and outer wall 123) is made of, for example, polyethylene, polypropylene, polyolefin of ethylene-propylene copolymer, polyester such as polyethylene terephthalate, polyvinyl chloride, ethylene-vinyl acetate copolymer. It can be made of a material such as a polymer, a crosslinked ethylene-vinyl acetate copolymer, a thermoplastic resin such as polyurethane, a polyamide, a polyamide elastomer, a polystyrene elastomer, a silicone rubber, or a latex rubber. Or the material of the inner wall part 121 and the outer wall part 123 may not be the same, for example, the outer wall part 123 is comprised with a polyamide elastomer in order to maintain the shape of the chemical | medical agent discharge | release part 127, and the inner wall part 121 becomes extensible. Thus, it may be composed of silicone rubber or fluororubber.

The drug held in the drug holding unit 125 is not particularly limited as long as it is intended for application to a biological lumen such as the blood vessel B. In this embodiment, since the medicine holding part 125 is configured by a closed space part formed between the inner wall part 121 and the outer wall part 123, the medicine holding part 125 can be used in the medicine holding part 125 regardless of the properties of the medicine. The medicine 130 can be suitably held. The properties of the drug 130 are widely selected from, for example, liquids, highly viscous liquids, gels, solids, powders, granules, water-soluble ones, fat-soluble ones, and any combination thereof. be able to.

Specific examples of the drug 130 include, for example, when the biological lumen to be applied is a blood vessel B, an anticancer agent, an immunosuppressive agent, an antibiotic, an antirheumatic agent, an antithrombotic agent, and an HMG-CoA reductase inhibitor. , Insulin resistance improver, ACE inhibitor, calcium antagonist, antihyperlipidemic agent, integrin inhibitor, antiallergic agent, antioxidant, GP IIb / IIIa antagonist, retinoid, flavonoid, carotenoid, lipid improver DNA synthesis inhibitors, tyrosine kinase inhibitors, antiplatelet drugs, anti-inflammatory drugs, biological materials, interferons, nitric oxide production promoters, paclitaxel, docetaxel, sirolimus, everolimus, biolimus, zotarolimus, and the like.

Note that the drug 130 may be filled in the drug holding unit 125 at a medical site (surgical site), for example. At the product shipping stage of the catheter 100, it is necessary to perform EOG sterilization or the like, and the period from shipment to use may be long. For example, if the medicine holding unit 125 is filled with the medicine 130 in the medical field, the medicine 130 that cannot be used due to the effect of EOG sterilization is used, or the medicine 130 with a short expiration date is used. Is also possible.

The configuration that does not particularly refer to the catheter 100 can be configured in the same manner as a known catheter device (for example, a microcatheter or a guide catheter) in the medical field, and detailed description thereof is omitted.

(Balloon catheter)
The balloon catheter 200 starts the release of the drug 130 from the drug release unit 127 by applying energy to the main body 110 of the catheter 100 (see FIGS. 5C and 6B).

The balloon catheter 200 is composed of a rapid exchange type balloon catheter generally used in the medical field.

As shown in FIG. 1, a balloon catheter 200 includes a balloon 210 that can be expanded and contracted as fluid flows in and out, a long shaft 220 having the balloon 210 disposed at the distal end, and a proximal end of the shaft 220. And a hub 230 disposed on the side. The shaft 220 is provided with a guide wire port 225 for introducing the guide wire 300 into the lumen of the shaft 220.

As shown in FIG. 5B and FIG. 5C, the balloon catheter 200 can be inserted into the lumen 111 of the main body 110 of the catheter 100. The balloon catheter 200 starts releasing the drug 130 from the drug discharge unit 127 when the balloon 210 is expanded while being inserted into the lumen 111.

Near the hand of the balloon catheter 200 (near the base end), a marker or the like for accurately positioning the balloon 210 with respect to the target site of the blood vessel B may be provided. The balloon 210 may have a protrusion or a reinforcing body for smoothly transferring the drug 130 from the drug holding part 125 to the outside or for breaking the outer wall part 123.

The specific configuration of the balloon catheter 200 is not particularly limited, and the balloon catheter 200 may be, for example, an over-the-wire type balloon catheter.

(Treatment method)
Next, a method for applying a medicine according to the present embodiment will be described with reference to FIGS.

As shown in FIG. 4, the method of applying the drug can be summarized as follows: a step of preparing a long member (S101), a step of preparing an energy application unit (S102), and a body portion of the long member as a body lumen. A step (S103) of introducing the energy application unit into the elongated member (S104), a step of applying a drug (S105), a step of moving the energy application unit (S106), Applying (S107).

An operator such as a doctor prepares the catheter 100 holding the medicine 130 in the medicine holding part 125 when starting the treatment for applying the medicine. In addition, the surgeon prepares a balloon catheter 200 that is used to start the release of the drug 130 from the drug holding unit 125.

Next, the surgeon introduces the main body 110 of the catheter 100 into the blood vessel B as shown in FIG. When introducing the catheter 100 into the blood vessel B, the surgeon can appropriately use a medical instrument such as a guide wire or a guide catheter. Alternatively, it may be introduced into the blood vessel B in a state where the balloon catheter 200 is inserted into the catheter 100 in advance and assembled.

Next, the operator inserts the balloon catheter 200 into the lumen 111 of the main body 110 of the catheter 100 as shown in FIG. The surgeon places the balloon 210 of the balloon catheter 200 at the target site (application target site) of the blood vessel B. When inserting the balloon catheter 200 into the catheter 100, the operator can move the balloon catheter 200 along the guide wire 300 inserted into the lumen 111 of the main body 110 prior to the balloon catheter 200.

Next, as shown in FIG. 5 (C), the surgeon introduces the body portion 110 of the catheter 100 into an arbitrary position (the purpose of the blood vessel B) with the balloon catheter 200 in a state where the body portion 110 is introduced into the blood vessel B. Energy (physical pressing force accompanying expansion of the balloon 210) is selectively applied to the periphery of the region. The inner wall 121 and the outer wall 123 are deformed so as to approach each other as the balloon 210 is expanded. The medicine holding part (space part) 125 formed between the inner wall part 121 and the outer wall part 123 is deformed so as to be crushed in a direction intersecting the axial direction when the inner wall part 121 and the outer wall part 123 approach each other. . The drug 130 held in the drug holding part 125 is released to the outside through the drug release part 127 formed in the outer wall part 123 as the drug holding part 125 is deformed so as to be crushed. It is applied to the blood vessel wall. The range where the drug 130 is applied in the blood vessel B (the length in the traveling direction of the blood vessel B) is within the range where the pressing force applied by the balloon 210 acts. Alternatively, once the necessary application is complete, the treatment may end here.

Next, the surgeon contracts the balloon 210 as shown in FIG. After the balloon 210 is deflated, the surgeon moves the balloon 210 to the proximal end side with respect to the main body 110. Note that the surgeon may move the balloon 210 to the distal end side of the main body 110 together with the main body 110 when the target site to which the next medicine 130 is applied is the distal end side of the main body 110.

Next, as shown in FIG. 6B, the surgeon expands the balloon 210 at a position different from the position described above (see FIG. 5C). The balloon 210 applies energy to the main body 110 of the catheter 100 to release the drug 130 held by the drug holding part 125 to the outside through the drug release part 127 and apply it to the blood vessel wall of the blood vessel B. To do. The medicine 130 is applied to a target site different from the target site described above.

Next, the surgeon contracts the balloon 210. After the balloon 210 is deflated, the surgeon removes the catheter 100 and the balloon catheter 200 from the living body. As shown in FIG. 6C, when the balloon 210 is expanded, the drug 130 is selectively applied to a portion of the blood vessel B corresponding to the portion to which energy is applied from the balloon 210. As described above, in the method of applying the drug 130 using the medical device 10, the drug 130 can be applied over an arbitrary range of the blood vessel B by adjusting the position and number of times of expansion of the balloon 210.

In the above-described embodiment, the operator applies the drug 130 by expanding the balloon 210 twice, but the number of times the balloon 210 is expanded is not particularly limited as long as it is one or more times.

Further, when the surgeon dilates the balloon 210 multiple times in one treatment, the balloon 210 is dilated so that the drug 130 is applied to a continuous position along the axial direction of the main body 110 of the catheter 100. There is no need to let them. For example, the operator may intermittently apply the drug 130 in the axial direction by expanding the balloon 210 a plurality of times at intervals in the axial direction of the main body 110 of the catheter 100.

Further, for example, the surgeon may perform a treatment to release the drug from the drug holding unit 125 more reliably by expanding the balloon 210 once and then expanding it again without shifting the position of the balloon 210. Good.

In addition, the operator prepares a plurality of types of balloon catheters having different lengths of the balloon 210, and each time the medicine 130 is applied, the balloon catheter is replaced to change the range of the medicine 130 to be applied. You may adjust. The surgeon can also apply the drug 130 using a perfusion balloon catheter 200A (FIG. 12) described later in combination with the balloon catheter 200.

As described above, the medical device 10 according to the present embodiment is provided between the inner wall 121 that forms the lumen 111, the outer wall 123 that forms the outer surface, and the inner wall 121 and the outer wall 123. A long portion having a medicine holding portion 125 capable of holding the medicine 130 released in B and a medicine releasing portion 127 formed on the outer wall portion 123 and capable of releasing the medicine 130 from the medicine holding portion 125 to the outer surface side. A catheter 100 including a main body 110 and an energy application unit (balloon catheter) 200 for starting the release of the drug 130 from the drug release unit 127 by applying energy to the main body 110.

According to the medical device 10 according to the present embodiment, the operator selects the target site of the blood vessel B by a simple procedure of operating the energy application unit 200 and applying energy to the main body 110 of the catheter 100. In particular, the drug 130 can be applied. Further, since the catheter 100 can hold the drug 130 in the drug holding unit 125 until the energy applying unit 200 applies energy to the main body 110, the catheter 100 is being delivered to the target site of the blood vessel B. In addition, it is possible to suitably prevent the medicine 130 from falling off.

The energy application unit 200 includes a balloon catheter that includes a balloon 210 that can be inserted into the lumen 111 of the main body 110 of the catheter 100 and that expands the lumen 111 to release the drug 130 from the drug discharge unit 127. . Therefore, the surgeon can selectively apply the medicine 130 to the target site by a simple operation of expanding the balloon 210 disposed in the lumen 111 of the main body 110. Moreover, since the medical device 10 can be comprised using the existing balloon catheter 200, the manufacturing cost of the medical device 10 can be reduced.

Moreover, the medicine holding part 125 extends along the axial direction of the main body part 110 of the catheter 100 and has a space part formed between the inner wall part 121 and the outer wall part 123. Therefore, until the medicine 130 is applied to the blood vessel B, the medicine 130 is held so as not to be exposed to the outer surface of the main body 110. It is possible to more reliably prevent the main body 110 from falling off.

Also, the drug release part 127 has a through hole formed in the outer wall part 123 so as to communicate the drug holding part 125 and the outer surface of the main body part 110. Therefore, the medicine release unit 127 can smoothly release the medicine 130 to the outside when the balloon 210 is expanded and receives a pressing force.

In addition, the drug application method according to this embodiment includes a catheter 100 including a long main body 110 in a state where the drug 130 is held in a drug holding part 125 provided between the inner wall part 121 and the outer wall part 123. Preparing an energy application unit 200 capable of applying energy for starting the release of the drug 130 from the drug holding unit 125, and introducing the main body 110 of the catheter 100 into the blood vessel B. In the state where the main body part 110 of the catheter 100 is introduced into the blood vessel B, the energy applying part 200 selectively applies energy to an arbitrary position of the main body part 110 of the catheter 100, thereby The step of applying the drug 130 to the target site (application target site) of the blood vessel B by releasing the drug 130 from 125. And, with a.

According to the medicine application method described above, the surgeon operates the energy application unit 200 to selectively apply to the target site of the blood vessel B by a simple procedure of applying energy to the main body 110 of the catheter 100. A drug 130 can be applied. Further, since the catheter 100 can hold the drug 130 in the drug holding unit 125 until the energy applying unit 200 applies energy to the main body 110, the catheter 100 is being delivered to the target site of the blood vessel B. In addition, it is possible to suitably prevent the medicine 130 from falling off.

In addition, in the medicine application method according to the present embodiment, the step of moving the energy application unit 200 relative to the medicine holding part 125 after the step of applying the medicine 130 is completed, and the catheter 100 is moved by the energy application part 200. Applying energy to the main body 110 and applying the drug 130 to a site different from the site where the drug 130 has already been applied.

According to the medicine application method described above, the surgeon shifts the position of the energy application unit 200 and applies energy to the main body 110 of the catheter 100 a plurality of times, thereby causing the blood vessel B to move in the traveling direction. The drug 130 can be applied over an arbitrary range. Therefore, for example, the surgeon can more reliably apply the medicine 130 to a lesioned part or the like that is formed long along the traveling direction of the blood vessel B.

In the drug application method according to the present embodiment, the drug 130 is applied by inserting the balloon catheter 200 provided in the energy application unit into the lumen 111 of the main body 110 of the catheter 100 and then using the balloon 210 provided in the balloon catheter 200. Do this by expanding. Therefore, the surgeon can selectively apply the medicine 130 to the target site by a simple operation of expanding the balloon 210 disposed in the lumen 111 of the main body 110. In addition, since the medicine can be applied using the existing balloon catheter 200, the medical economy can be improved.

Next, a medical device according to a modification will be described. The same components as those in the above-described embodiment are denoted by the same reference numerals, and the description thereof is omitted. In addition, configurations and treatment procedures that are not particularly mentioned in the description of the modified example can be configured substantially the same as those of the above-described embodiment.

(Modification 1)
As shown in FIGS. 7 and 8, the main body 110 </ b> A according to Modification 1 includes a misalignment prevention unit 410 that prevents the medicine 130 held by the medicine holding unit 125 from being displaced.

The misalignment prevention unit 410 is configured by a partition wall formed between the inner wall 121 and the outer wall 123. For example, as shown in FIG. 8, the misalignment prevention unit 410 can be formed over the entire circumference of the main body 110 </ b> A. However, the shape, position, number, and the like of the misalignment prevention unit 410 are not particularly limited. For example, the misregistration prevention unit 410 may extend spirally in the drug holding unit 125. When the misregistration prevention unit 410 is formed in this manner, the misregistration prevention unit 410 can prevent the drug 130 from being misaligned in both the circumferential direction and the axial direction of the main body 110A.

The misalignment prevention unit 410 is accompanied by the movement of the balloon catheter 200 when the balloon catheter 200 inserted into the lumen 111 of the main body 110A is moved in the axial direction relative to the main body 110A. Prevents 130 from moving in the axial direction. Thereby, it can prevent that the chemical | medical agent 130 is offset and arrange | positioned in the chemical | medical agent holding | maintenance part 125 at the front end side or the base end side.

In addition, it is preferable that the misalignment prevention unit 410 is made of a flexible resin material or the like so as not to hinder the deformation of the inner wall 121 when the balloon 210 is expanded in the lumen 111.

(Modification 2)
As shown in FIGS. 9A and 9B, the catheter according to Modification 2 is relatively movable along the axial direction of the main body 110 of the catheter, and the outer wall portion of the main body 110. 123, a masking member 510 that restricts the release of the drug 130 from the drug release portion 127 is provided.

The masking member 510 can be constituted by a hollow member that can slide with respect to the main body 110, for example. As shown in FIG. 9A, in a state where the masking member 510 covers the outer wall portion 123 and the drug release portion 127 from the outer surface side, even if the balloon 210 is expanded in the lumen 111, the drug release portion 127 The release of the drug 130 is limited. On the other hand, as shown in FIG. 9B, in a state where the masking member 510 is shifted in the axial direction of the main body portion 110 of the catheter 100 and a part of the outer wall portion 123 and the medicine discharge portion 127 are exposed from the masking member 510. By expanding the balloon 210, the drug 130 can be released from the drug release portion 127. As described above, by using the masking member 510, it is possible to control the portion to which the medicine 130 is applied more precisely.

Note that the catheter main body 110 may be provided with a dedicated lumen for inserting the masking member 510 on the outer side of the outer wall portion 123, for example. In addition, the drug 130 may be applied to a part of the circumference of the inner surface of the blood vessel by providing the masking member 510 on a part of the circumference.

The masking member 510 can be made of, for example, a known resin material or metal material.

(Modification 3)
As shown in FIGS. 10 (A) and 10 (B), the catheter according to the modified example 3 is a pushing assisting member 610 that assists pushing of the main body 110 when the main body 110 of the catheter is moved in the blood vessel B. Have

The pushing assisting member 610 can be formed of a hollow member that can slide with respect to the main body 110, for example. As shown in FIG. 10A, the rigidity of the main body 110 is reinforced by inserting the pushing assisting member 610 into the lumen 111 of the main body 110. Therefore, the pushing force of the main body 110 can be improved. The surgeon can smoothly move the main body 110 in the blood vessel B by improving the pushing force of the main body 110. In addition, the surgeon can prevent the main body 110 from being folded or kinked while moving the main body 110 in the blood vessel B. As shown in FIG. 10B, after delivering the catheter main body 110 to the target site of the blood vessel B, the pushing assisting member 610 is removed from the lumen 111. By removing the pushing assisting member 610, the surgeon can expand the balloon 210 within the lumen 111 to smoothly release the medicine 130.

The catheter body 110 may be provided with a dedicated lumen for inserting the push assisting member 610 inside the inner wall 121, for example.

The pushing assisting member 610 can be made of, for example, a known resin material or metal material.

(Modification 4)
As shown in FIG. 11, for example, the balloon catheter 200 can be used as a pushing assisting member that assists in the movement of the main body 110 of the catheter. When the balloon catheter 200 is used as a pushing assisting member, for example, a membrane material 710 for bringing the vicinity of the distal end of the balloon 210 into contact with the distal end of the main body 110 of the catheter can be attached. When the catheter main body 110 is moved, the catheter main body 110 can be smoothly moved by pushing the balloon catheter 200 while the tip of the balloon 210 is in contact with the membrane material 710. Note that the film material 710 can be provided with a through-hole through which the guide wire 300 or the like is inserted. Further, the film material 710 can be made of, for example, a known resin material.

(Modification 5)
As shown in FIG. 12, for example, a so-called perfusion balloon catheter 200A can be used as a balloon catheter. By using the perfusion balloon catheter 200A, it becomes possible to secure blood flow while the balloon 210 is expanded and the drug 130 is applied, so that the drug 130 is applied to the target site of the blood vessel B. Can be continued for a long time. As a result, the drug 130 can be more reliably applied to the target site of the blood vessel B. As the perfusion balloon catheter 200A, a known one in the medical field can be used.

(Modification 6)
13 and 14 show a part of the main body 110B according to Modification 6. FIGS. 13A and 13B are perspective views showing a state before and after the medicine is released from the slit 127 provided in the main body 110B. 14A and 14B are cross-sectional views showing a state before and after the medicine is released from the slit 127 included in the main body 110B.

As shown in FIGS. 13 (A) and 13 (B), the main body 110B includes an inner wall 121, an outer wall 123, and a medicine holding part 125 formed between the inner wall 121 and the outer wall 123. And a slit 127 formed in the outer wall portion 123 so that the medicine holding portion 125 and the outer surface of the main body portion 110B can communicate with each other.

As shown in FIG. 13A, the slit 127 is formed in a part of the main body 110 in the axial direction. As shown in FIG. 14A, a plurality of slits 127 are formed at different positions in the circumferential direction of the main body 110. The position in the axial direction where the slits 127 are formed, the number of the slits 127, the interval in the circumferential direction of the slits 127, etc. are not particularly limited.

FIG. 13B and FIG. 14B show a state when the medicine 130 is released from the medicine holding part 125 by expanding a part of the main body part 110B. For example, the surgeon expands the slit 127 by expanding the balloon 210 (see FIGS. 5A and 5B) of the balloon catheter 200 within the lumen 111 of the main body 110B, thereby expanding the slit 127. Thus, the medicine 130 held in the medicine holding part 125 can be released to the outside of the main body part 110B, and the surgeon has a slit 127 as shown in FIGS. In a state where the medicine is not spread, the medicine 130 held in the medicine holding part 125 can be prevented from leaking out from the main body part 110B, so that the surgeon moves the main body part 110B within a living body lumen such as a blood vessel. During this time, the medicine 130 can be prevented from being unintentionally applied to the patient.

In addition, the slit 127 should just be formed so that it can communicate with the outer wall part 123, and a part may be non-communication. Further, the slit 127 may be one that expands the balloon 210 to be opened and communicates.

(Other variations)
In the description of the embodiment, the example in which the balloon catheter is used as the energy application unit has been described. However, the energy application unit is not limited to the balloon catheter. As the energy application unit, for example, energy such as pressure, electricity, ultrasonic waves, electromagnetic waves, heat, etc., and each of these energies is applied to the main body of the catheter simultaneously or with a time difference, etc. It is also possible to use a device configured to release the drug from The main body of the catheter can be appropriately modified in the form of the medicine holding part and the medicine releasing part according to the form of energy applied by the energy applying part.

Further, the long member only needs to be a member that can be inserted into the living body lumen, and is not limited to the structure like the catheter described in the embodiment.

As described above, the medical device and the medicine application method according to the present invention have been described through the embodiment and a plurality of modified examples. However, the present invention is not limited to the contents described in the embodiment and each modified example, and is claimed. It is possible to change appropriately based on the description of the range.

This application is based on Japanese Patent Application No. 2018-055981 filed on Mar. 23, 2018, the disclosure of which is incorporated by reference in its entirety.

10 medical devices,
100 catheter (long member),
110, 110A body part,
111 lumens,
121 inner wall,
123 outer wall,
125 drug holder,
127 drug release part,
130 drugs,
200 balloon catheter (energy application part),
200A perfusion balloon catheter (energy application unit),
210 balloon,
220 shaft,
300 guidewire,
410 misalignment prevention unit,
510 masking member,
610 push-in auxiliary member,
710 membrane material,
B Blood vessel (biological lumen).

Claims

An inner wall part forming a lumen, an outer wall part forming an outer surface, a drug holding part provided between the inner wall part and the outer wall part and capable of holding a drug released in a living body lumen; A long member comprising an elongate main body formed on an outer wall and having a drug release part capable of releasing the drug from the drug holding part to the outer surface side;
A medical device comprising: an energy application unit that starts the release of the drug from the drug release unit by applying energy to the main body unit.
The said energy application part has a balloon catheter provided with the balloon which discharges the said chemical | medical agent from the said chemical | medical agent discharge | release part by expanding in the said lumen | rumen while being able to be inserted in the said lumen | rumen of the said main-body part. Medical devices.
The medical device according to claim 1, wherein the medicine holding portion has a space portion that extends along the axial direction of the main body portion and is formed between the inner wall portion and the outer wall portion. .
The medical device according to any one of claims 1 to 3, wherein the medicine release section includes a through hole formed in the outer wall section so as to communicate the medicine holding section and the outer surface of the main body section. .
The medical medicine according to any one of claims 1 to 3, wherein the medicine discharge section has a slit formed in the outer wall section so as to allow communication between the medicine holding section and the outer surface of the main body section. device.
The medical device according to any one of claims 1 to 5, further comprising a displacement prevention unit that prevents the medicine held by the medicine holding unit from being displaced.
A masking member that is relatively movable along the axial direction of the main body and that is disposed so as to cover the outer wall of the main body so as to limit the release of the medicine from the medicine discharge portion. The medical device according to any one of claims 1 to 6, comprising:
The medical device according to any one of claims 1 to 7, further comprising a pushing assisting member for assisting pushing of the main body when the main body is moved in a living body lumen.
Preparing an elongate member comprising an elongated main body in a state of holding a drug in a drug holding part provided between an inner wall part and an outer wall part;
Preparing an energy application unit capable of applying energy for initiating release of the drug from the drug holding unit;
Introducing the body portion into the body lumen;
With the main body portion introduced into the living body lumen, the energy is applied to the arbitrary position of the main body portion by the energy application portion, thereby releasing the medicine from the medicine holding portion. And applying the medicine to the application target site of the living body lumen.
Moving the energy application part relative to the body part after finishing the step of applying the medicine;
The medicine application according to claim 9, further comprising: applying energy to the body portion by the energy application section, and applying the medicine to a site different from a site to which the medicine is applied. Method.
The drug application according to claim 9 or 10, wherein the drug application is performed by inserting a balloon catheter provided in the energy application unit into a lumen of the main body part and expanding a balloon provided in the balloon catheter. Application method.