WO2023080251A1

WO2023080251A1 - Medical instrument

Info

Publication number: WO2023080251A1
Application number: PCT/JP2022/041506
Authority: WO
Inventors: 優畑; 陽一郎岩瀬; 宏伊藤; 弘樹吉川; 学有延; 拓心密岡; 聡山本
Original assignee: テルモ株式会社
Priority date: 2021-11-08
Filing date: 2022-11-08
Publication date: 2023-05-11
Also published as: JPWO2023080251A1

Abstract

[Problem] To provide a medical instrument capable of reducing the invasiveness of a procedure for the administration of an administration substance to a site in, for instance, the brain. [Solution] A medical instrument 100 includes: an administration device 10 that can be indwelling and that is capable of gradually releasing a drug over time; and a puncture part 220 that comprises an inside wall 221 capable of holding the administration device and that has a tip formed such as to be capable of piercing a vessel wall BW.

Description

medical instruments

The present invention relates to medical instruments.

In drug therapy for central nervous system diseases, it is difficult to obtain sufficient efficacy, especially since preparations containing macromolecules cannot pass through the blood-brain barrier. Regarding such a technique, Patent Document 1 describes an apparatus for administering a solid drug, which is an administration product, into the brain ventricle through an intracranial opening.

Japanese Patent Publication No. 2016-515866

The inventors of the present invention are concerned about the increased invasiveness of the procedure because the technique of Patent Document 1 administers the drug to the target site through an opening such as a burr hole made in the skull.

At least one embodiment of the present invention has been made in view of the above circumstances, and aims to provide a medical device capable of significantly reducing the invasiveness of a procedure for administering a substance such as a drug to a site such as the brain. purpose.

In order to solve the above problems, the medical device according to this embodiment has an administration device and a puncture section. The administration device is configured to be indwellable in a living body and to release a substance to be administered (such as a drug) over time. The puncture section includes an inner wall that can accommodate the administration device, and the tip is formed to be able to penetrate the blood vessel wall.

Since the medical device according to one embodiment of the present invention is configured as described above, it can contribute to reducing the invasiveness of the procedure for administering a substance such as a drug to a site such as the brain.

FIG. 2 is a schematic diagram of the brain for explaining the site on which the administration administered by the administration device that constitutes the medical device according to the present embodiment acts. FIG. 2 is a schematic diagram of the brain for explaining the site on which the administration administered by the administration device that constitutes the medical device according to the present embodiment acts. FIG. 2 is a schematic diagram of the brain for explaining the site on which the administration administered by the administration device that constitutes the medical device according to the present embodiment acts. FIG. 2 is a schematic diagram of the brain for explaining the site where the administration device that constitutes the medical device according to the present embodiment is placed. It is a figure which shows the structure of the medical instrument which concerns on 1st Embodiment. FIG. 10 is a diagram showing a state in which the indwelling section of the medical device is moved (arranged) from the internal space of the puncture section to the outside. Fig. 2 shows an administration device constituting a medical device; 4 is a flow chart showing how to use the medical instrument according to the first embodiment. It is a figure which shows the site|part which introduces the medical instrument which concerns on 1st Embodiment. It is a figure explaining the procedure concerning the usage method of a medical instrument. FIG. 4 is a diagram showing a state in which a tubular member penetrates a hole in a blood vessel wall made by a puncture section that constitutes a medical device, and a distal side expansion section that constitutes an indwelling section is expanded outside the blood vessel. The tubular member penetrates the hole in the blood vessel wall made by the puncture section that constitutes the medical device, expands the distal expansion section that constitutes the indwelling section outside the blood vessel, and expands the distal expansion section within the blood vessel. FIG. 10 is a diagram showing a state in which the FIG. 10 is a diagram showing a medical instrument according to a second embodiment, showing a state in which the indwelling section and the administration device that constitute the medical instrument are separated. FIG. 14 is a view showing a state in which the indwelling portion of the medical device shown in FIG. 13 and the administration device are connected; It is a figure which shows the site|part which introduces the medical device which concerns on 2nd Embodiment. FIG. 10 is a diagram showing a state in which a tubular member is pierced through a hole in a blood vessel wall made by a puncture section that constitutes the medical device according to the second embodiment, and the distal side expansion section is expanded outside the blood vessel. FIG. 10 is a diagram illustrating a state in which the medical device according to the second embodiment is subcutaneously indwelled in the vicinity of the neck;

Hereinafter, embodiments for carrying out the present invention will be described in detail with reference to the drawings. The embodiment shown here is an example for embodying the technical idea of the present invention, and does not limit the present invention. In addition, other practicable modes, embodiments, operation techniques, etc. that can be conceived by those skilled in the art without departing from the gist of the present invention are all included in the scope and gist of the present invention, and are described in the scope of claims. included within the scope of the claimed invention and its equivalents.

Furthermore, the drawings attached to this specification may be represented schematically by appropriately changing the scale, length-to-width ratio, shape, etc. from the actual thing for the convenience of illustration and ease of understanding. and does not limit the interpretation of the present invention.

Also, in the following description, ordinal numbers such as "first" and "second" may be added, but unless otherwise specified, they are used for convenience and do not prescribe any order.

FIGS. 1 to 4 are diagrams of the inside of a living body showing a site where an administration device 100 that constitutes the medical device 1 according to this embodiment is placed. FIG. 5 is a diagram showing the medical device 1 according to this embodiment. FIG. 6 is a diagram showing a state in which the indwelling section 230 that constitutes the medical device 1 is arranged from the internal space of the puncture section 220 to the outside. FIG. 7 is a diagram showing the configuration of the administration device 100. As shown in FIG.

The medical device 1 according to this embodiment can be indwelled by puncturing the blood vessel wall BW such as the hypopyramidal sinus SPI (see FIG. 4) with the administration device 100 constituting the medical device 1 . The dose X administered by the administration device 100 can act on the striatum ST located near the lateral ventricle LV as shown in FIGS. 1-3.

The medical device 1 according to the present embodiment continuously administers (sustained release) an administration substance X such as a drug to an administration target such as a living body for a long period of time (at least three weeks to several months, or even several years). It is a device for The substance X to be administered from the medical device 1 is a fluid composition capable of exhibiting a predetermined effect by long-term sustained release to the living body to which it is administered, and which can be continuously released from the device. The administered substance X is, for example, a drug (liquid drug) intended for treatment of a given disease. Pharmaceuticals include drugs. A drug can be any physiologically or pharmacologically active substance, especially one known to be delivered to the human or animal body. Drugs are used in peripheral nerves, adrenergic receptors, cholinergic receptors, skeletal muscle, cardiovascular system, smooth muscle, vascular system, synoptic sites, neuroexchange junctions, endocrine and hormonal system, immune system, reproductive organs system, skeletal system, local hormonal system, digestive and excretory system, histamine system, or central nervous system. Additionally, drugs include, but are not limited to, drugs used to treat infectious diseases, chronic pain, diabetes, autoimmune diseases, endocrine diseases, metabolic disorders, and rheumatic diseases. Additionally, drugs include peptides, proteins, polypeptides (e.g., enzymes, hormones, cytokines), nucleic acids, oligonucleotides, viruses, viral vectors, plasmids, nucleoproteins, polysaccharides, glycoproteins, lipoproteins, cells, steroids, analgesics. , local anesthetics, antibiotic agents, anti-inflammatory corticosteroids, eye drops, other small molecules for pharmaceutical use, or synthetic analogs of these types, and mixtures thereof, and the like. . Dosage X specifically includes the nusinersen sodium preparations Spinraza and baclofen, the idursulphase beta (genetical recombination) preparation Hyuntarase, the cerliponase alfa (genetical recombination) preparation Brineura, and dopamine. A D2 receptor agonist such as ropinirole can be used. In this embodiment, the administration device 100 that constitutes the medical device 1 is left in the patient's blood vessel to administer the administration X.
is slowly released.

The medical device 1 includes an administration device 100, a pushing member 210, a puncture section 220, and an indwelling section 230, as shown in FIGS. Details will be described below.

(Dosing device)
The administration device 100 is configured to be indwellable in a living body and to release the administered substance X gradually over time. The administration device 100 includes a body portion 10, a liquid permeable portion 20, a pressing portion 30, a stopper 40, and a discharge portion 50, as shown in FIG.

The main body 10 is composed of a hollow cylindrical member that constitutes the housing of the administration device 100 . The body portion 10 has a proximal end portion 12 positioned upstream where fluid components in the body fluid (extracellular fluid) flow, and a distal end portion 13 positioned downstream where the administered substance X is released into the living body. The liquid permeable portion 20 , the pressing portion 30 , the plug 40 , and the release portion 50 are arranged in order from the proximal end portion 12 toward the distal end portion 13 of the body portion 10 .

The main body 10 has a first space A1 and a second space A2 with the plug 40 as a boundary. The first space A1 is a space that is partitioned by the liquid permeable portion 20 and the plug 40 and that accommodates the pressing portion 30 . The second space A2 is a space (lumen) that is partitioned by the plug 40 and the discharge part 50 and that accommodates the administration material X. As shown in FIG. At least part of the second space A2 constitutes a sliding region of the plug 40. As shown in FIG.

The first space A1 and the second space A2 expand or contract as the plug body 40 slides before and after the administration device 100 is driven. That is, when the injection device 100 starts to drive, the first space A1 gradually widens as the plug 40 slides downstream by the pressing portion 30 . In addition, when the injection device 100 starts to drive, the second space A2 gradually narrows as the stopper 40 slides downstream by the pressing portion 30 . Since the first space A1 and the second space A2 share the inner space of the main body 10, if the first space A1 increases due to the sliding of the plug 40, the second space A2 decreases and the first space A1 decreases, the second space A2 increases.

As a constituent material of the body part 10, resin materials known in the medical field (acrylonitrile polymers, halogenated polymers, polyimide, polysulfone, polycarbonate, polyethylene, polypropylene, polychlorinated vinyl-acrylic acid copolymer, polycarbonate-acrylonitrile-butadiene-styrene, and polystyrene, etc.), metal materials (stainless steel, titanium, nickel, aluminum, vanadium, platinum, tantalum, gold, and their alloys, and gold plating ferroalloys, platinum-plated ferroalloys, cobalt-chromium alloys, and titanium nitride-coated stainless steels, etc.) are applicable. In addition, biocompatibility may be improved by appropriately suppressing or promoting thrombus formation, fibrosis, endothelialization, etc. by coating the surface.

The liquid permeable part 20 is arranged on the proximal end side of the main body part 10, isolates the inside of the administration device 100 from the living body, and allows only liquid components contained in body fluids in the living body to pass therethrough. The liquid permeable part 20 is composed of a member having a solid-liquid separating function that allows only the liquid component in the body fluid to pass therethrough. The liquid permeable part 20 is, for example, plasticized cellulosic materials, reinforced polymethyl methacrylates (PMMA) such as hydroxyl ethyl methacrylate (HEMA), and polyurethanes and polyamides, polyether-polyamide copolymers. Semipermeable membranes composed of materials such as elastomeric materials such as thermoplastic copolyesters can be applied.

The pressing part 30 is positioned downstream of the liquid permeable part 20 in the main body part 10 and upstream of the plug 40, and presses the plug 40 downstream. In this embodiment, the pressing portion 30 is an osmotic pressure engine that expands by being permeated by the liquid component that permeates the liquid permeable portion 20 using the principle of osmotic pressure. The pressing portion 30 gradually expands due to the liquid component that has permeated through the liquid permeable portion 20, and causes the stopper 40 to slide downstream due to the pressing action caused by the increase in internal pressure in the first space A1 accompanying this expansion.

The pressing portion 30 is made of a constituent material so that the pressing speed of the plug 40 (that is, the expansion speed of the pressing portion 30) corresponds to the usage conditions (sustained release period of the administered substance X, release amount per unit time, etc.). and size can be determined as appropriate. For example, salt or the like can be used for the pressing portion 30 . The administration device 100 can release a drug over a long period of time over several years, depending on the composition of the osmotic engine that constitutes the pressing portion 30 and the material and thickness of the semipermeable membrane that constitutes the liquid permeable portion 20. is.

The plug body 40 includes a columnar base portion 41 and an annular protrusion 42 projecting from the radially outer periphery of the base portion 41 . The stopper 40 is pressed by the pressing portion 30 and slidably moved downstream to push out the administration substance X accommodated in the second space A2 toward the discharge portion 50 side. The plug 40 is located downstream of the pressing portion 30 in the main body 10 , and its outer peripheral surface is in liquid-tight contact with the inner peripheral surface of the lumen 11 of the main body 10 and slides into the inner lumen 11 . placed as possible.

In this embodiment, the protruding portion 42 includes a first protruding portion 42a provided on the outer surface of the proximal end side of the base portion 41, a second protruding portion 42b provided substantially in the middle of the base portion 41, and an outer surface of the distal end side of the base portion 41. and a third projecting portion 42c provided in the . The outermost protruding vertex of the projecting portion 42 abuts the inner peripheral surface of the lumen 11 of the body portion 10 . The first projecting portion 42a, the second projecting portion 42b, and the third projecting portion 42c seal with the inner peripheral surface of the lumen 11 so that the administered substance X does not leak to the proximal end side of the stopper 40. .

Although the projecting portion 42 has a configuration including a first projecting portion 42a, a second projecting portion 42b, and a third projecting portion 42c, the number and arrangement position thereof are not particularly limited. Also, the plug 40 may be configured without the protruding portion 42 .

The constituent material of the plug 40 is a flexible material that maintains adhesion (liquid-tightness) to the inner peripheral surface of the lumen 11 of the main body 10 . The flexible material is preferably an elastic material, and examples of the elastic material include various rubber materials such as natural rubber, isoprene rubber, butyl rubber, chloroprene rubber, nitrile-butadiene rubber, styrene-butadiene rubber, and silicone rubber (particularly, rubber). Sulfur-treated), styrene elastomers, hydrogenated styrene elastomers, polyolefins such as polyethylene, polypropylene, polybutene, and α-olefin copolymers in these styrene elastomers, liquid paraffin, oils such as process oils, and talc , cast, mica, and the like. Furthermore, polyvinyl chloride elastomers, olefin elastomers, polyester elastomers, polyamide elastomers, polyurethane elastomers, and mixtures thereof can be used as constituent materials. As the constituent material, diene-based rubber, styrene-based elastomer, and the like are particularly applicable from the viewpoint of having elastic properties and being capable of γ-ray sterilization, electron beam sterilization, and autoclave sterilization. The stopper 40 may have a configuration that allows liquid-tight sliding within the lumen 11 . Therefore, the base 41 and the protruding portion 42 of the plug 40 may be made of a flexible material or an elastic material. It may be made of a hard material that does not have elasticity. Also, the sliding performance can be changed by coating the surface.

The release part 50 is arranged on the distal end side of the body part 10 and releases the administration substance X pushed out by the stopper 40 into the living body. The ejection part 50 has a through-hole 51 axially passing through a plate-shaped member having a predetermined thickness in order to efficiently administer the substance X into the living body. The release part 50 can release the administration substance X into the living body by connecting the through-hole 51 with a channel 241 of the tubular member 240 described later. Regarding the shape of the through-hole of the discharge part 50, it is necessary to allow the administered substance X to flow through the channel 241 of the tubular member 240, and the properties of the administered substance X and the easiness of diffusion of the administered substance X at the detention site of the administration device 100 are considered. etc. can be considered and determined as appropriate. In addition, the surfaces of the discharge part 50 and the tubular member 240 are coated with a hydrophilic material, a hydrophobic material, heparin, parylene, or the like to prevent adhesion of thrombus, clogging of the channel 241 due to cell migration, and an appropriate dose of the administered substance X. It can be used as appropriate for adjustment.

(Pushing member)
The pushing member 210 can be arranged on the proximal end side of the administration device 100 and configured to be able to push the administration device 100 toward the body lumen. The pushing member 210 has flexibility so that it can follow a complicatedly curved body lumen, and has relatively high rigidity so that the administration device 100 can be pushed.

As an example of the material of the pushing member 210, it can be made of a known resin material, metal material, or the like similar to that of the main body 10, or a combination thereof. The tip of the pushing member 210 is not particularly limited as long as it can push the administration device 100 toward the tip side, but it may not be connected to the administration device 100, or it may be detachable from the administration device 100 by providing an adhesive member or the like. may be configured.

(Puncture part)
Puncture section 220 includes an inner wall 221 forming an internal space capable of accommodating administration device 100 and indwelling section 230, as shown in FIG. . The piercing portion 220 may comprise a metal such as stainless steel, titanium, nickel, or alloys thereof such that the tip can pierce the vessel wall BW. The dimensions of the puncture part 220 may be, for example, 2 mm in diameter, 0.1 mm in thickness, and 150 cm in length in the longitudinal direction.

However, the material and specific dimensions of the puncture part 220 are not limited to the above, as long as the puncture part 220 can puncture in the vicinity of the blood vessel wall, which is the target site. The puncture unit 220 can confirm the puncture distance from the blood vessel wall BW and the like by providing a marker or the like at the tip so that the position of the tip can be visually recognized in a contrast image or the like. This can prevent damage to brain tissue.

(Detention part)
The indwelling section 230 is connected to the administration device 100 and is configured to be hooked on the blood vessel wall BW when the administration device 100 is placed in the blood vessel. The indwelling section 230 includes a tubular member 240, a distal extension section 250, and a proximal extension section 260, as shown in FIG. 5 and the like. Indwelling section 230 is configured to be housed in the internal space of puncturing section 220 .

The tubular member 240 is configured in an elongated shape, and is configured to be able to be accommodated in the internal space of the puncture section 220 and arranged at the puncture site of the blood vessel wall BW punctured by the puncture section 220 . Tubular member 240 includes channel 241 and opening 242 as shown in FIG.

The flow path 241 is provided inside the tubular member 240 and communicates with the discharge portion 50 of the administration device 100 so that the administered substance X from the through hole 51 of the discharge portion 50 of the administration device 100 can flow. The tubular member 240 can form the channel 241 so that the wall thickness in the circumferential direction is substantially uniform. The opening 242 is provided in communication with the flow path 241, and configured to be able to release the administered substance X flowing from the flow path 241 to the outside. In this embodiment, the opening 242 can be configured as a hole facing the distal side at the distal end of the tubular member 240 in the longitudinal direction. However, the ejection portion is not limited to the above as long as the administered substance X can be ejected to the outside.

The tubular member 240 can be made of the same material as the main body 10 of the administration device 100. Further, by winding a wire, a spring, or the like around the tubular member 240, it is possible to improve the pushing force when the tubular member 240 is pushed forward in the longitudinal direction. Tubular member 240 can be configured to communicate with a bore formed in discharge portion 50 . At this time, by applying a coating such as a swelling gel to the proximal surface of the distal side expansion part 250, it is possible to prevent the spinal fluid from leaking out when placed in the blood vessel wall BW. Further, the tubular member 240 is configured to be integrally connected with the administration device 100 in this embodiment. At this time, by installing a sterilization-grade filter in the lumen of the tubular member 240, it is also possible to prevent infections caused by administration of the substance X to be administered.

Distal-side expanding portion 250 and proximal-side expanding portion 260 can be accommodated in the internal space of puncturing portion 220, and are positioned outside the internal space of puncturing portion 220 in a radial direction relative to the state in which they are positioned in the internal space. It is configured to be expandable and deformable so that the dimensions of the Distal extension 250 and proximal extension 260 comprise extension members that are shaped to be larger than the dimensions of the interior space of puncture 220 in an unloaded state when not in the interior space of puncture 220 . The expansion members of the distal side expansion section 250 and the proximal side expansion section 260 include an elastic member such as a shape memory alloy, a shape memory resin, or a spring biased to be larger than the internal space of the puncture section 220. can be done.

The distal side extension part 250 is provided on the distal side of the tubular member 240 . As shown in FIG. 6, the distal side expansion part 250 expands radially outward by being placed outside the tubular member 240, and can be caught on the blood vessel wall BW with the puncture part 220 puncturing the blood vessel wall BW. . The distal side expansion part 250 prevents the distal side expansion part 250 from passing through the blood vessel wall such as the vein wall and moving into the blood vessel by being caught on the blood vessel wall BW.

The proximal-side expanding portion 260 is formed closer to the proximal side than the distal-side expanding portion 250 in the longitudinal direction of the tubular member 240, can be accommodated in the internal space of the puncture portion 220, and expands in a radial direction intersecting the longitudinal direction. configured as possible. Similar to the distal-side expanding portion 250, the proximal-side expanding portion 260 can be expanded radially outward by including a shape memory alloy or an elastic member, and when the indwelling portion 230 is placed in the blood vessel, the vascular wall BW It is formed so as to push on.

This can prevent or suppress the tubular member 240 of the indwelling section 230 and the administration device 100 from moving in the longitudinal direction of the tubular member 240 . Proximal extension 260 may have a coating on its outer surface to inhibit thrombus formation within the blood vessel when extended external to puncture 220 .

In addition, the tip side expansion part 250 can be provided with a hinge jt that enables bending at least at a predetermined angle at an intermediate position in the longitudinal direction when the tip part and the puncture part 220 are housed in the internal space. Similarly, the proximal side extension part 260 can be provided with a hinge jt at an intermediate position in the longitudinal direction when it is housed in the internal space of the puncture part 220 (Fig. 5, See Figure 6).

(how to use)
Next, a procedure using the medical instrument 1 according to this embodiment will be described. FIG. 8 is a flow chart explaining how to use the medical device 1, and FIGS. 9 to 12 are diagrams for explaining how to use the medical device 1. FIG. Referring to FIG. 8, the procedure of the medical device 1 will be outlined. The medical device 1 is introduced into the body lumen (ST1), the puncture unit 220 is moved to the target site, and the puncture unit 220 punctures the blood vessel wall BW. (ST2), and the administration device 100 is left at the target site (ST3). Details will be described below.

First, as shown in FIG. 9, the operator inserts the guide wire GW into the blood vessel from the femoral vein FV by the Seldinger method, and the tip of the guide wire GW is passed through the jugular vein into the dura mater (lower pyramidal) venous sinus. move up to After the tip of the guide wire GW has been delivered to the dural venous sinus, the operator inserts the guide catheter GC along the guide wire GW and moves the tip of the guide catheter GC to the vicinity of the dural venous sinus (Fig. 10). In this embodiment, the femoral vein FV is punctured, but the puncture site is not limited to this, and the jugular vein, axillary vein, cubital vein, radial vein, ulnar vein, leg vein, etc. can also be punctured. .

After delivering the tip of the guide catheter GC to the dural venous sinus, the operator removes the guide wire GW delivered to the dural venous sinus from the biological lumen. Next, the operator introduces the medical device 1 into the inner space of the guide catheter GC and moves it to the blood vessel wall BW near the dural venous sinus (ST1). By providing a marker at the distal end portion of the puncture portion 220 of the medical device 1, the position of the puncture portion 220 can be confirmed with a contrast image or the like.

After the medical device 1 is delivered to the vascular wall BW near the dural venous sinus, the operator determines the position of the vascular wall BW to be indwelled and pushes the medical device 1 to cause the puncture part 220 to pierce the vascular wall BW. (ST2). After puncturing the blood vessel wall BW with the puncturing unit 220 , the operator positions the tip of the puncturing unit 220 so as not to damage the brain tissue and fixes the position of the puncturing unit 220 in the longitudinal direction. The distal side extension part 250 is pushed out from the puncture part 220 to the distal side.

As a result, the tubular member 240 penetrates the blood vessel wall BW punctured by the puncture part 220 from the inner space of the puncture part 220, and the distal end moves to the outside. As a result, the distal expansion portion 250 expands and deforms outward in the radial direction crossing the longitudinal direction of the tubular member 240 while being placed in the subarachnoid space or the like outside the blood vessel (see FIG. 11). As a result, even if the tubular member 240 is unintentionally drawn into the blood vessel, the distal side expanding portion 250 can prevent or suppress the position of the medical device 1 from moving in the longitudinal direction, particularly into the blood vessel.

Next, the operator withdraws the guide catheter GC from the body, and withdraws the pushing member 210 and the puncture section 220 from the body. By withdrawing the puncturing section 220 from the indwelling section 230, the proximal side expansion section 260 constituting the indwelling section 230 is moved (arranged) from the internal space of the puncturing section 220 to the outside. A side extension 260 extends radially outward. This allows the proximal extension 260 to flare radially outward and contact the surrounding vessel wall BW, as shown in FIG.

Accordingly, it is possible to prevent or suppress displacement of the tubular member 240 and the administration device 100 together with the distal side expansion portion 250 in the body. Next, the operator stops bleeding at the punctured site of the thigh. As a result, the administration device 100 is left in the blood vessel in the ventricle (ST3), and the administration substance X can be slowly released to the target site for a long period of time.

As described above, the medical device 1 according to this embodiment has the administration device 100 and the puncture section 220. The administration device 100 can be left in the living body and is configured to release the substance X over time. The puncture part 220 includes an inner wall 221 forming an internal space capable of accommodating the administration device 100, and the tip thereof is formed so as to be able to penetrate the blood vessel wall BW.

By configuring in this way, the invasiveness of the procedure for administering the drug to the target site can be reduced compared to the conventional procedure for administering the drug to the target site by introducing a cannula from the skull.

The medical device 1 also has an indwelling section 230 that is connected to the administration device 100 and that can be caught on the blood vessel wall BW when the administration device 100 is placed in the blood vessel. By configuring in this way, it is possible to prevent or suppress displacement of the administration device 100 from the indwelling position.

In addition, the indwelling section 230 includes a tubular member 240 and a distal extension section 250 . Tubular member 240 is elongated, can be accommodated in the internal space of puncturing section 220 , and is configured to be arranged at the puncture site of blood vessel wall BW punctured by puncturing section 220 . Distal side expansion section 250 is provided on the distal side of tubular member 240 , can be accommodated in the internal space of puncture section 220 , and is configured to be expandable and deformable while exposed from the internal space of puncture section 220 . With such a configuration, it is possible to easily maintain the state in which the administration device 100 is indwelled inside the target blood vessel.

In addition, the indwelling section 230 includes a proximal extension section 260 that is provided closer to the proximal side than the distal extension section 250 in the longitudinal direction of the tubular member 240 and that is expandable in a radial direction intersecting the longitudinal direction. By configuring in this way, the administration device 100 can be made difficult to move inside the blood vessel near administration of the substance X to be administered. The proximal extension 260 also allows the tubular member 240 to be positioned near the center of the body lumen, thereby preventing or suppressing the formation of thrombi.

Further, the tubular member 240 includes a channel 241 through which the administration substance X flowing through the administration device 100 can flow, and an opening 242 through which the administration substance X flowing through the channel 241 can be released to the outside. By configuring in this way, the administration agent X used for central nervous system diseases can be administered under conditions where efficacy is likely to be obtained.

The administration device 100 includes a body portion 10, a liquid-permeable portion 20, a stopper 40, a pressing portion 30, and a substance X to be administered. The main body part 10 has a lumen that accommodates a substance to be administered X such as a drug. The liquid permeable part 20 is arranged in the lumen of the main body part 10 and configured to allow liquid components contained in body fluid to pass therethrough. The plug 40 is arranged in the lumen of the main body 10 and is slidable in the lumen. The pressing portion 30 is arranged upstream of the plug 40 in the lumen of the main body 10 and configured to press the plug 40 downstream. The substance to be administered X is housed downstream of the stopper 40 in the lumen of the main body 10, and is released into the living body by sliding the stopper 40 downstream when the administration device 100 remains in the living body. be.

By configuring in this manner, the substance X to be administered can be slowly released over a long period of time, such as 0.01 mL/day or less, while the administration device 100 remains in the living body. In this manner, the administration device 100 can administer the administration substance X at a rate assuming long-term sustained release, which can contribute to suppressing an increase in cerebrospinal pressure and the like.

In a procedure using the medical device 1 according to the present embodiment, the medical device 1 is introduced into a living body lumen, the puncture unit 220 is moved to the target site, and the puncture unit 220 punctures the blood vessel wall BW. placed at or near the target site. If the puncture part 220 is punctured into the inferior pyramidal sinus SPI or the like near the jugular vein using such a method, the administered substance X can be locally injected between the lateral ventricle LV and the third ventricle TV, etc., regardless of the drug. can be administered.

In addition, by changing the vein to be punctured, such as the superior sagittal sinus, the administered substance X can be locally administered to any site, such as just above the cerebrum, if the superior sagittal sinus is used. In addition, the risk of infection can be reduced by embedding the administration device 100 serving as a reservoir into the blood vessel.

(Second embodiment)
13 and 14 are diagrams for explaining the medical device 1a according to the second embodiment. In the first embodiment, it was explained that the tubular member 240 of the indwelling section 230 and the administration device 100 are integrally connected, and the medical device 1 is introduced into the body lumen from the femoral vein FV. However, the medical device can also be configured as follows.

The medical device 1a has an administration device 100a, a puncture section 220, and an indwelling section 230a, as shown in FIGS. Since the puncture part 220 and the distal end side extension part 250 are the same as those in the first embodiment, description thereof will be omitted.

(Dosing device)
The administration device 100 includes a main body portion 10 a , a liquid permeable portion 20 , a pressing portion 30 , a stopper 40 and a discharge portion 50 . The liquid permeable portion 20, the pressing portion 30, the plug 40, and the discharging portion 50 are the same as those in the first embodiment, and thus description thereof is omitted.

The main body part 10a has a proximal end part 12 and a distal end part 13 as in the first embodiment, and the internal space is divided into a first space A1 and a second space A2 by the plug 40. The main body 10a is detachably attached to the tubular member 240a by providing an engaging portion 14 such as a screw on the inner wall surface of the main body 10 on the release portion 50 side, unlike the first embodiment. The release portion 50 can be provided at or near the engagement portion 14 . Other configurations of the main body portion 10a are the same as those of the first embodiment, so description thereof will be omitted.

(tubular member constituting the indwelling section)
The tubular member 240a is configured to have a channel 241 and an opening 242 as in the first embodiment, as well as an engaged portion 243 (see FIG. 13). The engaged portion 243 is configured to have a shape that engages with the engaging portion 14 of the main body portion 10a on the base end side of the hollow member forming the flow path 241 . The engaged portion 243 can be engaged with the engaging portion 14 by providing an internal thread or the like on the inner wall surface of the hollow member. Thus, the indwelling section 230a can be configured to be attachable/detachable (connectable) to the administration device 100a. Note that the engaging portion 14 may be provided with a cap or the like so as not to be contaminated by the time of engagement. A sterilizing grade filter may also be placed in the lumen of tubular member 240a to prevent contamination of the lumen due to engagement.

(how to use)
Next, a procedure using the medical instrument 1a according to this embodiment will be described. First, the operator makes an incision in the skin at the site where the administration device 100a is to be implanted to expose the jugular vein JV. Then, the operator introduces the guide wire GW from the jugular vein JV into the living body lumen by the Seldinger technique, and moves the tip of the guide wire GW to the dural venous sinus in the same manner as in the first embodiment. In the present embodiment, puncture is performed from the jugular vein JV, but the puncture site is not limited to this, and puncture can also be performed from the jugular vein, axillary vein, cubital vein, radial vein, ulnar vein, leg vein, and the like. be.

After delivering the tip of the guide wire GW to the dural sinus, the operator introduces the guide catheter GC into the body along the guide wire GW and moves it to the target site. After moving the tip of the guide catheter GC to the target site, the operator withdraws the guide wire GW, introduces the medical device 1a into the internal space of the guide catheter GC, and pushes the tip to the vicinity of the blood vessel wall BW at the site to be punctured. Move (see ST1 in FIG. 8). After confirming that the puncture part 220 of the medical device 1a has been delivered to the vicinity of the target blood vessel wall BW by a contrast image or the like, the operator pushes the puncture part 220 and the tip of the puncture part 220 punctures the blood vessel wall BW ( (See ST2 in FIG. 8).

Next, as in the first embodiment, the operator positions the tip of the puncture unit 220 from the blood vessel wall BW to such an extent that the brain tissue is not damaged, and the puncture unit is primed with a saline solution or the administration substance X. 220 is moved from the internal space of the puncture unit 220 to the outside. As a result, the tubular member 240a penetrates the blood vessel wall BW punctured by the puncture unit 220 from the internal space of the puncture unit 220, and the distal end moves to the outside. As a result, the distal side expanding portion 250 of the indwelling portion 230a expands radially outward in the subarachnoid space or the like outside the blood vessel wall BW.

Next, the operator removes the guide catheter GC and the puncture section 220 from the body lumen. Puncturing part 220 can be removed from the living body by separating a part of the outer surface from another part of the outer surface (such a mechanism can be called a peel cut).

Next, the operator stops bleeding from the jugular vein JV, which was the puncture site. Next, the operator fits the engaging portion 243 of the tubular member 240a to the engaging portion 14 of the main body portion 10a to connect the detaining portion 230a to the administration device 100a. Next, the operator sutures the skin and the periphery of the implanted site in a state where the administration device 100a is subcutaneously implanted. In addition, the operator may sew the injection device 100a to the jugular vein JV or muscle layer in order to fix the injection device 100a more firmly.

By the above-described operation, the administration device 100a can be subcutaneously indwelled so that the substance to be administered X accommodated inside the administration device 100a can be gradually released. When replacing the administration device 100a, the skin is incised to release the engagement between the engaged portion 243 of the tubular member 240a and the engaging portion 14 of the body portion 10a, and the body portion 10a of the new administration device 100a is replaced. The engaging portion 14 is engaged with the engaged portion 243 of the tubular member 240a to suture the skin.

In addition, when the administration device 100a is not replaced immediately and the indwelling portion 230a is maintained in the body, the channel 241 of the tubular member 240a is washed with physiological saline or the like, plugged, and replaced with a new one. The plug is removed when implanting the administration device 100a.

As described above, in this embodiment, the administration device 100a is configured to be connectable (detachable) to the indwelling section 230a. Therefore, when one administration device does not complete the administration of the drug, the administration device can be replaced relatively easily.

It should be noted that the present invention is not limited to the above-described embodiments, and various modifications are possible within the scope of the claims. In the first embodiment and the second embodiment, the

medical device

1, 1a has been described as having the detention unit 230 or the detention unit 230a. may not be provided. In this case, the administration device can be accommodated in the inner space of the puncture part, and after the puncture part punctures the blood vessel wall BW around the target site, the puncture part can be removed from the puncture site leaving the administration device. .

In the second embodiment, when the administration device is subcutaneously indwelled, the administration device 100a and the indwelling unit 230a are detachable. It does not have to be detachable from the indwelling part.

This application is based on Japanese Patent Application No. 2021-182020 filed on November 8, 2021, the disclosure of which is incorporated by reference in its entirety.

1, 1a medical instruments,
10, 10a main body,
20 liquid permeable part,
30 pressing part,
40 plugs,
50 discharge section,
100, 100a dosing device,
220 piercer,
221 inner wall,
230, 230a detention unit,
240, 240a tubular member,
241 flow path,
242 openings,
250 distal extension,
260 proximal extension;
BW vessel wall,
X dose.

Claims

an administration device that can be indwelled in vivo and that can release an administered substance over time;
and a puncture part having an inner wall that forms an internal space that can accommodate the administration device, and a puncture part that has a distal end that can penetrate a blood vessel wall.
The medical device according to claim 1, which has an indwelling portion that is connected or connectable to the administration device and that can be hooked on the wall of the blood vessel in a state in which the administration device is placed in the blood vessel.
The indwelling section includes an elongated tubular member that can be accommodated in the internal space of the puncture section and that can be arranged at the puncture site of the blood vessel wall punctured by the puncture section; 3. The medical device according to claim 2, further comprising: , and a distal side expansion part that can be accommodated in the internal space of the puncture part and that is expandable and deformable in a state of being exposed from the internal space of the puncture part.
4. The indwelling section according to claim 3, wherein the indwelling section includes a proximal expansion section formed closer to the proximal side than the distal expansion section in the longitudinal direction of the tubular member and expandable in a radial direction intersecting the longitudinal direction. medical instruments.
4. The medical device according to claim 3, wherein the tubular member comprises a flow path through which the administration material flowing through the administration device can flow, and an opening through which the administration material flowing through the flow path can be released to the outside.
The administration device includes a main body portion having a lumen for containing the substance to be administered, a liquid permeable portion arranged in the lumen for allowing liquid components contained in body fluid to pass therethrough, and a liquid permeable portion arranged in the lumen for allowing the lumen to pass through. a tightly slidable plug body, a pressing part arranged upstream of the plug body in the lumen and pressing the plug body downstream, and a pressure part downstream of the plug body in the lumen. and the administered substance that is housed and released into the living body by sliding the stopper toward the downstream side in a state in which the administration device is left in the living body. medical instruments.