WO2023100571A1 - Medical instrument and medical device - Google Patents

Medical instrument and medical device Download PDF

Info

Publication number
WO2023100571A1
WO2023100571A1 PCT/JP2022/040618 JP2022040618W WO2023100571A1 WO 2023100571 A1 WO2023100571 A1 WO 2023100571A1 JP 2022040618 W JP2022040618 W JP 2022040618W WO 2023100571 A1 WO2023100571 A1 WO 2023100571A1
Authority
WO
WIPO (PCT)
Prior art keywords
medical device
movable
posture
blood vessel
tube
Prior art date
Application number
PCT/JP2022/040618
Other languages
French (fr)
Japanese (ja)
Inventor
拓心 密岡
優 畑
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2023100571A1 publication Critical patent/WO2023100571A1/en

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps

Definitions

  • the present invention relates to medical instruments and medical devices that deliver a substance to be administered released from an administration device that is left in vivo to a delivery site.
  • a device described in Patent Document 1 below is known as a medical device that transdermally delivers a predetermined administered substance (medicine, etc.) to a delivery site in vivo.
  • the device of Patent Document 1 includes a cannula, and a hub attached to the proximal end of the cannula and placed outside the body to transport a predetermined fluid (such as a drug to be administered) to the lumen of the cannula.
  • a predetermined fluid such as a drug to be administered
  • a patient When administering an object to be administered using the device disclosed in Patent Document 1, a patient pierces a blood vessel with a cannula and administers the object to a patient using an infusion device (syringe, infusion pump, etc.) via a hub. be done. For this reason, the patient is not only restricted in his/her activities such as sitting or lying down while administering the substance, but also undergoes a series of procedures from cannula puncture to administration (administration procedure). is required and the burden is heavy.
  • a cannula is connected to an administration device containing a substance to be administered and left in the body (for example, subcutaneously), and the substance to be administered is transvascularly delivered to the delivery site through the cannula.
  • an administration device containing a substance to be administered and left in the body (for example, subcutaneously)
  • the substance to be administered is transvascularly delivered to the delivery site through the cannula.
  • the cannula When the above medical device is indwelled in vivo, the cannula is placed through the blood vessel wall, so it is necessary to seal the puncture site of the blood vessel to prevent bleeding.
  • the living tissue for example, subcutaneous tissue, muscles, blood vessels, etc.
  • the initial indwelling posture of the medical device may change due to deformation of the surrounding living tissue.
  • a large load is likely to be applied particularly to the puncture site of the cannula, and in some cases, the seal may be released and bleeding may occur.
  • At least one embodiment of the present invention has been made in view of the above-described circumstances, and specifically aims to reduce the risk of bleeding by suppressing the load applied to the puncture site of the blood vessel due to the movement of the surrounding living tissue.
  • the purpose is to provide medical instruments and medical devices that can
  • the medical device is attached to an administration device that is indwelled in a position in which the surrounding biological tissue moves in vivo, and delivers a substance to be administered that is released from the administration device.
  • a medical device for delivery to a site wherein the first portion is connected to the administration device and extends from the administration device through the blood vessel to the delivery site and is positioned closer to the administration device than the vascular wall of the blood vessel serving as the puncture site. and a second portion positioned closer to the delivery site than the blood vessel wall, and attached to the first portion to follow the movement of the living tissue while holding a portion of the first portion. and a movable part that moves by
  • a medical device includes the above-described medical device, and an administration device having the medical device attached to its distal end side and indwelled at a position in which movement occurs in the surrounding biological tissue in a living body.
  • the administered substance released from the administration device is delivered to the delivery site through the medical device.
  • a medical instrument and a medical device capable of reducing the risk of bleeding by suppressing the load applied to the puncture site of the blood vessel due to the movement of the surrounding living tissue.
  • FIG. 4 is a schematic cross-sectional view showing a state in which the movable portion of the medical device according to the first embodiment is movable;
  • FIG. 2 is a conceptual diagram showing a state in which the medical device according to the first embodiment is placed inside the living body; 4B is a partially enlarged sectional view of FIG. 4A;
  • FIG. 4 is a conceptual diagram showing a state in which the indwelling posture of the medical device according to the first embodiment has changed in vivo.
  • FIG. 5C is a partially enlarged cross-sectional view of FIG. 5B; It is a figure which shows the structure of the medical device which concerns on a 2nd form. It is a schematic sectional drawing which shows the medical device which concerns on a 2nd form.
  • FIG. 11 is a schematic cross-sectional view showing a state in which the movable portion of the medical device according to the second embodiment is movable; It is a figure which shows the structure of the medical device which concerns on a 3rd form.
  • FIG. 11 is a schematic cross-sectional view showing a medical device according to a third embodiment; FIG.
  • FIG. 11 is a schematic cross-sectional view showing a state in which the movable portion of the medical device according to the third embodiment is movable; It is a figure which shows the structure of the medical device which concerns on a 4th form. It is a schematic sectional drawing which shows the medical device which concerns on a 4th form.
  • FIG. 11 is a schematic cross-sectional view showing a state in which the movable portion of the medical device according to the fourth embodiment is movable;
  • the side that is inserted into a biological lumen is defined as the “distal end”, and the side opposite to the distal end side (the side that is grasped or operated by the operator) is defined as the “base end”.
  • distal end means a certain range in the axial direction (longitudinal direction) from the distal end
  • base end means a certain range in the axial direction from the most proximal end.
  • the vascular wall (a two-dot chain line) is schematically shown, and the Y1 side of the vascular wall is the outside of the blood vessel, and the Y2 side is the inside of the blood vessel.
  • the medical device 1 As shown in FIG. to the intended delivery site.
  • the medical device 1 is left in the living body, penetrates the blood vessel Bv with the medical device 20, and transvascularly delivers the administered substance X to the delivery site.
  • the object X to be administered contained in the administration device 10 is a fluid composition that exerts a predetermined effect on the delivery site and can be released from the device.
  • the administered object X is, for example, a drug (liquid drug) intended to treat a predetermined disease.
  • Drugs 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 mobile sites, endocrine and hormonal system, immune system, reproductive organs system, skeletal system, local hormonal system, digestive and excretory system, histamine system, or central nervous system.
  • Drugs also 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. . Specifically, spinraza, baclofen, hyuntalase, brineura, and the like can be used as the administered substance X.
  • drugs include peptides, proteins, polypeptides (e.g. enzymes, hormones, cytokines), nucleic acids, oli
  • the administration device 10 includes at least a storage section 11 that stores a subject X to be administered, and a release mechanism 12 that releases the subject X stored in the storage section 11 .
  • the administration device 10 accommodates the object X to be administered, and is left in a living body (subcutaneous tissue S as an example) while being connected to the medical device 20 .
  • the containing portion 11 is a space formed inside the administration device 10 to contain the substance X to be administered.
  • the container 11 communicates with the outside (specifically, the medical device 20 ) via an administration opening formed in the housing of the administration device 10 .
  • the object X to be administered is released from the opening by driving the release mechanism 12 .
  • the release mechanism 12 is configured to be able to control the administration operation of the substance X to be administered based on the administration period of the substance X and predetermined administration conditions (administration timing, administration time, dose, etc.). As long as the release mechanism 12 has a control function related to the administration of the object X to be administered as described above, the configuration of the device for releasing the object to be administered X, the power source required for driving, etc. are not particularly limited.
  • the release mechanism 12 can be configured to include, for example, an extrusion section that pushes out the administration subject X accommodated in the accommodation section 11, and a driving section that drives the extrusion section under predetermined conditions.
  • the release mechanism 12 can use, as a power source for the drive section, a source capable of generating the power required to drive the drive section, such as moisture in the body, a small battery, or electromagnetic waves.
  • the administration device 10 may be a continuous administration device that is left in the body and is capable of sustainably releasing the object X over a long period of time.
  • the continuous administration device includes a body portion having a lumen, a liquid permeable portion disposed on the proximal end side of the body portion, and a liquid (moisture in body fluid) disposed upstream of the liquid permeable portion and permeating the liquid permeable portion. ) that expands and pushes the stopper downstream (osmotic engine), the stopper that can slide liquid-tightly in the lumen of the main body, and the administered substance pushed out by the sliding of the stopper.
  • the driving portion of the release mechanism 12 is composed of the liquid permeable portion and the pressing portion, the pushing portion is composed of the plug, and the power source of the driving portion is the liquid in the body fluid. becomes water.
  • the medical device 20 follows the movement of a tube 21 connected to the administration device 10 and the body tissue while part of the tube 21 is held so as to maintain the posture of the tube 21 puncturing the blood vessel Bv.
  • a movable part 22 is provided.
  • the tube 21 is a long tubular member connected to the distal end of the administration device 10 and extending from the administration device 10 through the blood vessel Bv to the delivery site.
  • the tube 21 has a lumen communicating from the proximal end of the first portion 211 to the distal end of the second portion 212 .
  • the tube 21 has a first portion 211 located on the administration device 10 side with the blood vessel wall Bw as a boundary, and a second portion 212 located on the delivery site side with the blood vessel wall Bw as a boundary.
  • a first portion 211 of the tube 21 is left in the living body outside the blood vessel Bv, and a second portion 212 is inserted through the blood vessel wall Bw into the blood vessel Bv.
  • the tip of the second portion 212 is inserted through the blood vessel Bv to the delivery site, and delivers the administered substance X released from the administration device 10 to the delivery site.
  • the portion of the first portion 211 of the tube 21 to which the movable portion 22 is attached becomes the third portion 213 . That is, the third portion 213 constitutes part of the first portion 211 of the two portions that separate the tube 21 with the blood vessel wall Bw as a boundary.
  • connection between the tube 21 and the administration device 10 is a form in which a thread (or thread groove) formed at the distal end of the administration device 10 and a thread groove (or thread) formed at the proximal end of the tube 21 are screwed together.
  • a thread or thread groove
  • a thread groove or thread formed at the proximal end of the tube 21
  • the movable portion 22 is attached to the first portion 211 of the tube 21, and maintains communication with the first portion 211 and the second portion 212, and at least the second portion 212 is maintained in a posture of puncturing the blood vessel Bv. , while holding a part of the first portion 211, it moves following the movement of the living tissue. More preferably, the movable part 22 is mounted on the first part 211 in a state of covering and holding the third part 213 corresponding to the mounting part of the movable part 22 in the first part 211 , and is located on the tip side of the third part 213 .
  • the third part 213 and the first part closer to the proximal end than the third part 213 are moved by the movement of the living tissue.
  • 211 can be moved by following the posture change.
  • the movable part 22 maintains communication between the first portion 211 and the second portion 212 of the tube 21, and allows the administration device 10 and the tube 21 to assume a posture (for example, an indwelling posture of the administration device 10) according to the movement of surrounding living tissue. , the posture of puncturing the blood vessel Bv of the tube 21 and the posture of indwelling in the living body), it moves following the movement of the living tissue. Since the movable portion 22 moves following the movement of the living tissue, the first portion 211 and the second portion 212 on the distal side (delivery site side) of the third portion 213 are affected by the movement of the living tissue. it gets harder. Therefore, the medical device 20 can reduce the burden on the blood vessel Bv due to displacement of the tube 21 .
  • a posture for example, an indwelling posture of the administration device 10.
  • the movable part 22 can be mounted so as to cover the third part 213 and its surroundings so as to prevent the lumen of the third part 213 from collapsing due to the movement of the surrounding living tissue. As a result, the third portion 213 of the tube 21 is crushed by the surrounding living tissue, and the communication state of the tube 21 is maintained.
  • the tube 21 is not particularly limited as long as it is a material that can be applied in the medical field and has sufficient rigidity to suppress buckling against the movement of the surrounding living tissue.
  • the constituent material of the tube 21 is, for example, polyolefin (eg, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or these mixture of two or more), polyolefin elastomer, crosslinked polyolefin, polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polyurethane elastomer, fluorine resin, polycarbonate, polystyrene, polyacetal, polyimide, polyetherimide , polymer materials such as aromatic polyetherketone, resin materials such as mixtures thereof, shape memory alloys, metal materials such as stainless steel, tantalum, titanium,
  • polyolefin e
  • the third portion 213 of the tube 21 can be made of the same material as the first portion 211, but can more flexibly follow the movement of the movable portion 22 accompanying the change in posture of the administration device 10 and the tube 21. Therefore, a material other than the third portion 213, which is more flexible than the first portion 211 and the second portion 212, can be applied. Even if the third portion 213 of the medical device 20 is made of a material that is more flexible than the first portion 211 and the second portion 212, by attaching the movable portion 22 while covering the third portion 213, Collapse of the lumen due to surrounding living tissue can be prevented.
  • the medical device 1A to medical device 1D can be configured as shown in the following first to fourth modes. It should be noted that each form described below is merely an example and does not limit the components and actions of the medical device 1 . In addition, in the first to fourth embodiments described below, detailed descriptions of components having the same functions as those of the above-described embodiments are omitted, and configurations, members, and methods of use that are not particularly mentioned are It may be similar to the embodiment described above.
  • the medical devices 1A to 1D differ in the configuration and action of the movable portions 22A to 22D, respectively, and other configurations (administration devices 10A to 10D, tubes 21 of the medical devices 20A to 20D, etc.) , can be configured in the same manner as the administration device 10 and the tube 21 described above. Therefore, in the following description, the configurations and actions of the movable parts 22A to 22D, which are characteristic requirements of each form, will be mainly referred to.
  • the medical device 1A comprises an administration device 10A and a medical instrument 20A, as shown in FIGS. 2-3B.
  • the movable portion 22A of the medical device 20A is mounted on the proximal side of the third portion 213A of the tube 21A, and serves as the center of rotation when the posture of the first portion 211A on the proximal side of the third portion 213A changes. and a second movable portion 221Ab attached to the distal end side of the third portion 213A and rotatably holding the first movable portion 221Aa while covering a part of the first movable portion 221Aa.
  • the first movable portion 221Aa is rotatably fitted into the second movable portion 221Ab.
  • the movable part 22A has a configuration in which the first movable part 221Aa is rotatably held.
  • the first movable portion 221Aa rotates while holding part of the third portion 213A so as to follow changes in posture of the administration device 10A and the tube 21A, and can absorb these changes in posture. Therefore, the medical device 20A can maintain the posture of the tube 21A (more specifically, the placement posture of the first portion 211A on the distal side of the third portion 213A and the puncture posture of the second portion 212A with respect to the blood vessel Bv). .
  • the first movable part 221Aa is a substantially hollow sphere with an internal space.
  • the first movable portion 221Aa is partially formed with an opening 222Aa that communicates with the internal space, and is formed with an insertion hole 223Aa at a position facing the opening 222Aa through which the third portion 213A of the tube 21A is inserted.
  • the first movable portion 221Aa is fitted into the internal space of the second movable portion 221Ab with the opening 222Aa facing the opening 222Ab of the second movable portion 221Ab.
  • the second movable part 221Ab is a substantially hollow sphere having an internal space into which the first movable part 221Aa can be fitted.
  • the second movable portion 221Ab is partially formed with an opening 222Ab that communicates with the internal space, and is formed with an insertion hole 223Ab at a position facing the opening 222Ab, through which the third portion 213A of the tube 21A is inserted.
  • the second movable portion 221Ab rotatably holds the first movable portion 221Aa that is inserted into the internal space with the opening 222Aa facing the opening 222Ab.
  • the opening 222Ab of the second movable part 221Ab preferably has an opening size (opening diameter) that does not come off when the first movable part 221Aa rotates. Also, when the first movable portion 221Aa is rotated in a state where the first movable portion 221Aa is fitted in the second movable portion 221Ab, the surrounding living tissue enters between the first movable portion 221Aa and the second movable portion 221Ab.
  • the outer size (outer diameter) of the first movable portion 221Aa and the inner space size (inner diameter) of the second movable portion 221Ab are defined so as to prevent this.
  • the outer peripheral surface of the first movable portion 221Aa and the inner peripheral surface of the second movable portion 221Ab may be defined to be in contact with each other. It may be defined so that there is a gap.
  • the tip of the third portion 213A of the tube 21A is fixed to the inner peripheral surface of the insertion hole 223Ab while protruding from the opening 222Aa by a predetermined length from the tip side to the base end side.
  • the base end side of the third portion 213A is fixed to the inner peripheral surface of the insertion hole 223Aa. That is, the third portion 213A is held by the second movable portion 221Ab at the distal end and held by the first movable portion 221Aa at the proximal end, but the other portions are in a free state in which they are not fixed.
  • the third portion 213A can be flexibly deformed, so that the lumen shape of the third portion 213A is maintained. and buckling of the tube 21A is prevented.
  • the medical device 1A is placed in the subcutaneous tissue S near the neck as an indwelling position in the living body, and the blood vessel Bv through which the tube 21A is punctured is the jugular vein.
  • the indwelling position of the medical device 1A is not limited to the vicinity of the neck shown in FIGS. 4A and 4B, since the blood vessel Bv through which the tube 21A is punctured is determined by the position of the delivery site of the object X to be administered.
  • the indwelling position of the medical device 1A and the blood vessel Bv to be punctured can be appropriately determined according to the position of the delivery site of the object X to be administered.
  • the medical device 1A is indwelled in the subcutaneous tissue S in the vicinity of the neck where the jugular vein to be punctured runs based on the position of the delivery site of the object X to be administered.
  • the medical device 1A is to be indwelled, first, the skin near the indwelling position is incised to expose the jugular vein (blood vessel Bv), and the tube 21A is introduced by puncturing the blood vessel Bv.
  • the tube 21A can be introduced by puncturing the blood vessel Bv by a well-known introduction method.
  • the administration device 10A is left in the subcutaneous tissue S (or fixed to the jugular vein with suture or adhesive) while being connected to the tube 21A.
  • the indwelling posture of the administration apparatus 10A has changed from the beginning of indwelling due to the movement of the surrounding living tissue.
  • the medical device 1A includes the medical instrument 20A, it can move about the first movable portion 221Aa of the movable portion 22A as the center of rotation, and can absorb changes in posture of the administration device 10A. Therefore, even if the posture of the administration device 10A or the like changes due to the movement of the living tissue, the medical device 1A can maintain the placement posture of the first portion 211A on the distal side of the third portion 213A of the tube 21A and the blood vessel of the second portion 212A. The puncture posture with respect to Bv can be maintained.
  • the medical device 20A is attached to the proximal side of the third portion 213A of the tube 21A, and is the first movable body that serves as the center of rotation as the posture of the first portion 211A, which is closer to the proximal side than the third portion 213A, changes.
  • a movable portion composed of a portion 221Aa and a second movable portion 221Ab attached to the distal end side of the third portion 213A and rotatably holding the first movable portion 221Aa while covering a part of the first movable portion 221Aa. 22A. As shown in FIG. 3B and FIG.
  • the movable part 22A can maintain the movement of the body tissue around the medical device 1A even if the placement posture of the components of the medical device 1A (for example, the administration device 10A) changes from the initial placement. It is possible to move the first movable portion 221Aa as the center of rotation to absorb changes in posture of the administration device 10A. Therefore, the indwelling posture of the first portion 211A on the distal side of the third portion 213A of the tube 21A and the puncturing posture of the second portion 212A with respect to the blood vessel Bv are maintained in the initial state of indwelling. Therefore, the medical device 1A including the medical instrument 20A suppresses the load applied to the puncture site of the blood vessel Bv even if the surrounding living tissue moves after being placed in the living body. Risk can be reduced.
  • the medical device 1B of the second embodiment differs from the medical device 1A of the first embodiment in that the medical device 20B includes a cover portion 230 that covers the second movable portion 221Bb holding the first movable portion 221Ba. . Therefore, the administration device 10B, the tube 21B, and the movable portion 22B (the first movable portion 221Ba and the second movable portion 221Bb) of the medical device 20B, which constitute the medical device 1B, are configured with the corresponding portions of the medical device 1A of the first embodiment. and functions match.
  • the medical device 1B according to the second embodiment has the same configuration as the medical device 1A according to the first embodiment, but is given a different reference numeral.
  • the medical device 1B includes an administration device 10B and a medical instrument 20B, as shown in any of FIGS. 6, 7A, and 7B.
  • the movable portion 22B of the medical device 20B is mounted on the proximal side of the third portion 213B of the tube 21B, and serves as the center of rotation when the posture of the first portion 211B on the proximal side of the third portion 213B changes.
  • a cover portion 230 is provided to cover the held second movable portion 221Bb.
  • the cover part 230 forms a substantially hollow sphere.
  • the cover portion 230 is partially formed with an opening portion 231 that allows the attitude change of the first portion 211B closer to the base end than the third portion 213B of the tube 21B connected to the first movable portion 221Ba.
  • the opening portion 231 is defined to have an opening size (opening diameter) that does not hinder the posture change of the first portion 211B closer to the proximal end than the third portion 213B of the tube 21B due to the rotation of the first movable portion 221Ba.
  • the cover portion 230 is formed with an insertion hole 232 through which the third portion 213B of the tube 21B that is inserted through the second movable portion 221Bb is inserted.
  • the inner peripheral surface of the insertion hole 232 may be in contact with the outer peripheral surface of the third portion 213B, or may have some gap between it and the third portion 213B.
  • the cover part 230 is a member for preventing the surrounding living tissue from being pulled into the gap between the first movable part 221Ba and the second movable part 221Bb when the first movable part 221Ba rotates. Therefore, the cover portion 230 is configured to cover at least the overlapping region between the first movable portion 221Ba and the second movable portion 221Bb in the fitted state of the first movable portion 221Ba and the second movable portion 221Bb.
  • the constituent material of the cover part 230 is not particularly limited as long as it is a material having biocompatibility, such as a material similar to that of the tube 21B.
  • the medical device 20B is configured by the first movable portion 221Ba, the second movable portion 221Bb, and the cover portion 230 that covers the second movable portion 221Bb while holding the first movable portion 221Ba.
  • a portion 22B is provided.
  • the movable part 22B is set to the first movable position even if the placement posture of the components of the medical device 1B (for example, the administration device 10B) changes from the initial placement due to the movement of the living tissue around the medical device 1B. It is possible to absorb changes in posture of the administration device 10B by moving around the portion 221Ba as the center of rotation.
  • the indwelling posture of the first portion 211B on the distal side of the third portion 213B of the tube 21B and the puncturing posture of the second portion 212B with respect to the blood vessel Bv are maintained in the initial state of indwelling. Therefore, the medical device 1B including the medical instrument 20B suppresses the load applied to the puncture site of the blood vessel Bv even if the surrounding living tissue moves after being indwelled in the living body. Risk can be reduced.
  • the medical device 20B since the medical device 20B includes the cover portion 230, in addition to the above-described effect of reducing the risk of bleeding, the rotational movement of the first movable portion 221Ba causes the living body to move between the first movable portion 221Ba and the second movable portion 221Bb. It is also possible to achieve the effect of preventing the rotation of the first movable portion 221Ba from being hindered due to the tissue being pulled in.
  • the medical device 1C of the third embodiment differs in structure from the movable portion 22A of the medical device 1A of the first embodiment and the movable portion 22B of the medical device 1B of the second embodiment. It has the structure which supports the 3rd part 213C, deform
  • the medical device 1C includes an administration device 10C and a medical instrument 20C, as shown in FIGS. 8, 9A, and 9B.
  • the movable portion 22C of the medical device 20C includes a support portion 221Ca that supports the third portion 213C while deforming following changes in posture of the first portion 211C on the proximal side of the third portion 213C of the tube 21C, and a third portion 213C. and a protective portion 221Cb that has an opening 222C that allows the position of the first portion 211C on the proximal side of the portion 213C to change, and that covers the third portion 213C supported by the support portion 221Ca.
  • the support portion 221Ca is attached to the protection portion 221Cb (in FIG. 9A, the inner peripheral surface of the protection portion 221Cb), and deforms in accordance with the change in posture of the third portion 213C due to the movement of the living tissue to support at least the third portion 213C.
  • one end of the supporting portion 221Ca is connected to the boundary between the first portion 211C and the third portion 213C.
  • the connection position with is not particularly limited.
  • the support part 221Ca is preferably composed of a member having a characteristic of following changes in posture of the third portion 213C and supporting the third portion 213C so that it does not buckle due to excessive posture change.
  • the support portion 221Ca can be configured by a spring member such as a coiled spring or an elastic member such as an elastic body made of synthetic rubber.
  • the protective part 221Cb has a substantially hollow hemispherical shape with an opening 222C in part. Further, the protective portion 221Cb is formed with an insertion hole 223C through which the third portion 213C is inserted. The protection portion 221Cb is attached to the tip side of the third portion 213C while covering the third portion 213C.
  • the protective portion 221Cb is configured to cover the third portion 213C and a portion of the distal end side of the first portion 211C that is continuous with the third portion 213C, and is configured to cover at least the third portion 213C. All you have to do is Also, the opening size (opening diameter) of the opening 222C of the protection portion 221Cb is not particularly limited, and may be any size that does not hinder the posture change of the first portion 211C.
  • the third portion 213C is fixed to the protective portion 221Cb with the distal end inserted through the insertion hole 223C, the base end side is supported in a suspended state by the support portion 221Ca, and the other portions are in a free state where they are not fixed. Become. Therefore, the third portion 213C, for example, when the posture of the first portion 211C changes, the support portion 221Da is deformed (extended or contracted) in a predetermined direction, so that the first portion 211C closer to the proximal end than the third portion 213C is. (see FIG. 9B).
  • the medical device 20C includes the support portion 221Ca that supports the third portion 213C while deforming in accordance with the posture change of the first portion 211C closer to the proximal end than the third portion 213C of the tube 21C, and the third portion 213C.
  • the movable portion 22C includes a protection portion 221Cb that has an opening 222C that allows the position of the first portion 211C on the proximal side of the portion 213C to change, and that covers the third portion 213C supported by the support portion 221Ca. Prepare. As shown in FIG.
  • the movable part 22C is configured to support the support part 221Ca even if the placement posture of the components of the medical device 1C (for example, the administration device 10C) changes from the initial placement due to the movement of the living tissue around the medical device 1C. can appropriately deform to follow the posture change of the first portion 211C closer to the proximal side than the third portion 213C. Therefore, the indwelling posture of the first portion 211C on the distal side of the third portion 213C of the tube 21C and the puncturing posture of the second portion 212C with respect to the blood vessel Bv are maintained in the initial state of indwelling. Therefore, the medical device 1C including the medical instrument 20C suppresses the load applied to the puncture site of the blood vessel Bv even if the surrounding living tissue moves after being placed in the living body. Risk can be reduced.
  • the medical device 1D of the fourth form is a modification of the medical device 1C of the third form, and has a configuration in which the shape and function of the support portion 221Ca of the third form are partially changed.
  • the medical device 1D as shown in FIGS. 10, 11A, and 11B, includes an administration device 10D and a medical instrument 20D.
  • the movable portion 22D of the medical device 20D includes a support portion 221Da that supports the third portion 213D while deforming in accordance with the posture change of the first portion 211D closer to the proximal end than the third portion 213D of the tube 21D; and a protective portion 221Db that has an opening 222D that allows the position of the first portion 211D on the proximal side of the portion 213D to change, and that covers the third portion 213D supported by the support portion 221Da.
  • the support part 221Da is attached to the protection part 221Db, and supports at least the third part 213D while deforming according to the posture change of the third part 213D caused by the movement of the living tissue.
  • the support portion 221Da is attached to an opening 222D formed in the protection portion 221Db, and an insertion hole 224D through which the third portion 213D is inserted is formed in a substantially central portion.
  • the support portion 221Da has a shape in which a flexible, substantially circular plate material is bellows-folded along the radial direction of the tube 21D from the outer peripheral surface of the third portion 213D (concentrically alternating peaks and valleys).
  • the support portion 221Da can be made of an elastic material (for example, synthetic rubber or synthetic resin) that has flexibility and can expand and contract following changes in the posture of the third portion 213D. Note that the support portion 221Da does not necessarily need to be made of an elastic material because it has a structure that can be expanded and contracted by the accordion folding. Further, as shown in FIG. 11A, the support portion 221Da is connected to the boundary portion between the first portion 211D and the third portion 213D. The connection position with is not particularly limited.
  • the protective part 221Db has a substantially hollow hemispherical shape with an opening 222D in part. Further, the protective portion 221Db is formed with an insertion hole 223D through which the third portion 213D is inserted. The protective portion 221Db is attached to the tip side of the third portion 213D while covering the third portion 213D.
  • the opening size (opening diameter) of the opening 222D of the protection portion 221Db is not particularly limited, and may be any size that does not hinder the posture change of the first portion 211D.
  • the third portion 213D is fixed to the support portion 221Da with its distal end inserted through the insertion hole 223D and its base end inserted through the insertion hole 224D, and other portions are left unfixed. Therefore, the third portion 213D is deformed (extended or contracted) in a predetermined direction by the support portion 221Da when the posture of the first portion 211D is changed, for example, so that the first portion 211D on the base end side of the third portion 213D is moved. (See FIG. 11B).
  • the medical device 20D supports the third portion 213D of the tube 21D while deforming in accordance with the posture change of the first portion 211D closer to the proximal end than the third portion 213D of the tube 21D, as in the third embodiment.
  • a portion 221Da, and a protection portion 221Db that has an opening 222D that allows a change in posture of the first portion 211D on the proximal side of the third portion 213D and that covers the third portion 213D supported by the support portion 221Da.
  • a movable part 22D is provided. As shown in FIG.
  • the movable part 22D is configured to support the supporting part 221Da even if the placement posture of the components of the medical device 1D (for example, the administration device 10D) changes from the initial placement due to the movement of the living tissue around the medical device 1D. can appropriately deform to follow the posture change of the first portion 211D closer to the proximal side than the third portion 213D. Therefore, the indwelling posture of the first portion 211D on the distal side of the third portion 213D of the tube 21D and the puncturing posture of the second portion 212D with respect to the blood vessel Bv are maintained in the initial state of indwelling. Therefore, the medical device 1D including the medical instrument 20D suppresses the load applied to the puncture site of the blood vessel Bv even if the surrounding living tissue moves after being indwelled in the body. Risk can be reduced.
  • the medical device 20 is attached to the administration device 10 that is indwelled at a position in the living body where movement occurs in the surrounding living tissue, and the administration device 10 ejects the object X to be administered.
  • a tube 21 having a first portion 211 and a second portion 212 located closer to the delivery site side than the blood vessel wall Bw, and attached to the first portion 211 to hold a portion of the first portion 211 while the body tissue is being cut. and a movable part 22 that moves following the movement.
  • the movable part 22 can move while holding at least a part of the first portion 211 of the tube 21 while following changes in posture of the administration device 10 and the tube 21 due to movement of living tissue. Therefore, the posture of the second portion 212 of the tube 21 to puncture the blood vessel Bv can be maintained. Therefore, even if the postures of the administration device 10 and the tube 21 change due to the movement of the living tissue at the indwelling destination, the medical device 20 absorbs these posture changes and suppresses the load applied to the puncture site of the blood vessel Bv. can reduce the risk of bleeding due to unsealing.
  • the movable part 22 is mounted on the first part 211 while covering and holding the third part 213 corresponding to the mounting part of the movable part 22 in the first part 211, It is also possible to adopt a configuration in which the third portion 213 and the first portion 211 closer to the proximal end than the third portion 213 are moved following the change in posture caused by the movement of living tissue.
  • the third portion 213 of the tube 21 to which the movable portion 22 is attached is covered with the movable portion 22, so that the third portion 213 is prevented from being crushed by the surrounding living tissue.
  • the communication state of the tube 21 is maintained.
  • the movable portion 22A is mounted on the proximal side of the third portion 213A so as to cover a part of the third portion 213A, and is located on the proximal side of the third portion 213A.
  • the first movable part 221Aa which serves as the center of rotation when the posture of the first part 211A changes, is attached to the distal end side of the third part 213A, and the first movable part 221Aa can be rotated while covering a part of the first movable part 221Aa. It is good also as a structure provided with 2nd movable part 221Ab hold
  • the medical device 20A can rotate around the first movable portion 221Aa even if the placement posture of the administration device 10A changes from the initial placement due to the movement of the living tissue around the medical device 1A. posture change can be absorbed. As a result, the indwelling posture of the first portion 211A on the distal side of the third portion 213A of the tube 21A and the puncturing posture of the second portion 212A with respect to the blood vessel Bv are maintained in the initial state of indwelling. Therefore, the medical device 20A can suppress the load applied to the puncture site of the blood vessel Bv, and reduce the risk of bleeding due to releasing the seal of the puncture site.
  • the movable portion 22B has an opening 231 that allows the first portion 211B on the proximal side of the third portion 213B to change its posture, and the first movable portion 221Ba.
  • a configuration may be adopted in which a cover portion 230 that covers the held second movable portion 221Bb is further provided.
  • the medical device 20B includes the cover portion 230. Therefore, in addition to the effect of reducing the risk of bleeding caused by changes in the indwelling posture of the components of the medical device 1B (for example, the administration device 10B), the first It is also possible to prevent the rotation of the first movable portion 221Ba from being hindered due to the living tissue being drawn between the first movable portion 221Ba and the second movable portion 221Bb due to the rotational movement of the movable portion 221Ba.
  • the movable portions 22C and 22D are deformed while following the posture change of the first portions 211C and 211D closer to the proximal side than the third portions 213C and 213D. It has support portions 221Ca and 221Da that support the three portions 213C and 213D, and opening portions 222C and 222D that allow posture changes of the first portions 211C and 211D closer to the proximal side than the third portions 213C and 213D.
  • a configuration including protection portions 221Cb and 221Db covering the third portions 213C and 213D supported by 221Ca and 221Da may be provided.
  • the components of the medical devices 1C and 1D change their placement postures from the beginning of placement due to the movement of the living tissue around the medical devices 1C and 1D. Even so, the support portions 221Ca and 221Da can follow the tubes 21C and 21D while deforming appropriately to absorb the posture change of the administration devices 10C and 10D.
  • the medical instruments 20C and 20D can suppress the load applied to the puncture site of the blood vessel Bv, and reduce the risk of bleeding due to releasing the seal at the puncture site.
  • the medical device 1 is equipped with any of the medical instruments 20 (20A to 20D) described above and the medical instrument 20 (20A to 20D) on the distal end side, and is equipped with the surrounding biological tissue in vivo. and an administration device 10 (10A to 10D) indwelled at a position where movement occurs, and the administration subject X released from the administration device 10 (10A to 10D) is passed through the medical device 20 (20A to 20D). delivered to the delivery site.
  • the administration device 10 and the tube 21 may change from the initial placement posture due to the movement of the surrounding living tissue.
  • a load is applied to the blood vessel wall Bw of the blood vessel Bv, which is the puncture site, and there is a risk that the seal will be released and bleeding will occur.
  • the movable part 22 can move while holding at least a part of the first portion 211 of the tube 21 while following changes in posture of the administration device 10 and the tube 21 due to movement of living tissue.
  • the puncturing posture of the second portion 212 with respect to the blood vessel Bv can be maintained.
  • the medical device 1 including the medical device 20 absorbs the change in posture and reduces the load applied to the puncture site of the blood vessel Bv. and reduce the risk of bleeding due to unsealing of the puncture site.

Abstract

[Problem] To minimize a load acting on a blood vessel puncture site due to movement of surrounding tissue and reduce the risk of bleeding. [Solution] This invention is mounted on an administration device 10 indwelled in a location in a living body at which movement occurs in the surrounding tissue, and delivers an administered substance X released from the administration device 10 to a delivery site, the invention comprising: a tube 21 having a first portion 211 extending from the administration device 10 through a blood vessel Bv to the delivery site, the first portion 211 being located on the administration device side of the blood vessel wall Bw of the blood vessel Bv that is to be a puncture site, and a second portion 212 located on the delivery site side of the blood vessel wall Bw; and a movable part 22 that is mounted on the first portion 211 and that moves to follow tissue movement while holding a part of the first portion 211 so that at least the attitude at which the second portion 212 is puncturing the blood vessel Bv is maintained while maintaining a state in which the first portion 211 and the second portion 212 are communicating.

Description

医療器具および医療デバイスmedical instruments and devices
　本発明は、生体内に留置される投与装置から放出された被投与物を送達部位に送達する医療器具および医療デバイスに関する。 The present invention relates to medical instruments and medical devices that deliver a substance to be administered released from an administration device that is left in vivo to a delivery site.
　生体内の送達部位に所定の被投与物（薬剤など）を経皮的に送達する医療デバイスとして、下記特許文献１に記載された装置が知られている。特許文献１の装置は、カニューレと、カニューレの近位端に取り付けられた状態で体外に配置されて所定の流体（被投与物となる薬剤など）をカニューレの内腔に輸送するハブと、を含み、カニューレの一部を血管（静脈）内に留置して経皮的に生体内に流体を輸送するものである。 A device described in Patent Document 1 below is known as a medical device that transdermally delivers a predetermined administered substance (medicine, etc.) to a delivery site in vivo. The device of Patent Document 1 includes a cannula, and a hub attached to the proximal end of the cannula and placed outside the body to transport a predetermined fluid (such as a drug to be administered) to the lumen of the cannula. A part of the cannula is placed in a blood vessel (vein) to percutaneously transport fluid into the body.
特表２０１２－５１７２７１号公報Japanese Patent Publication No. 2012-517271
　特許文献１に開示される装置を用いて被投与物を投与する場合、患者は、血管にカニューレを穿通してハブを介して輸液器具（シリンジや輸液ポンプなど）を用いて被投与物が投与される。そのため、患者は、被投与物を投与している間、着座姿勢や横臥姿勢を取るなど行動が制限されるだけでなく、投与の都度、カニューレの穿刺から投与に至る一連の処置（投与処置）が必要となり負担が大きい。 When administering an object to be administered using the device disclosed in Patent Document 1, a patient pierces a blood vessel with a cannula and administers the object to a patient using an infusion device (syringe, infusion pump, etc.) via a hub. be done. For this reason, the patient is not only restricted in his/her activities such as sitting or lying down while administering the substance, but also undergoes a series of procedures from cannula puncture to administration (administration procedure). is required and the burden is heavy.
　このような課題を解決するため、被投与物を収容した投与装置にカニューレを接続して生体内に留置（例えば皮下留置）し、カニューレを介して経血管的に被投与物を送達部位に送達することが考え得る。このように、投与装置とカニューレとで構成した医療デバイスを生体内に留置することで、患者は、投与の都度行われる投与処置や投与中の行動制限から解放され、日常生活を支障なく行うことができる。 In order to solve such problems, a cannula is connected to an administration device containing a substance to be administered and left in the body (for example, subcutaneously), and the substance to be administered is transvascularly delivered to the delivery site through the cannula. can be considered. In this way, by indwelling the medical device composed of the administration device and the cannula in the living body, the patient is freed from the administration treatment to be performed each time of administration and movement restrictions during administration, and can carry out daily life without hindrance. can be done.
　上記医療デバイスを生体内に留置するにあたり、カニューレは、血管壁を貫通して配置されるため、血管の穿刺部位をシールして出血を抑える必要がある。 When the above medical device is indwelled in vivo, the cannula is placed through the blood vessel wall, so it is necessary to seal the puncture site of the blood vessel to prevent bleeding.
　ところが、医療デバイスの留置位置の周囲に存在する生体組織（例えば皮下組織、筋肉、血管など）は、日常生活の範囲内の動作や姿勢であっても、それ相応に変形する。医療デバイスは、周囲の生体組織の変形により、当初の留置姿勢が変化することがある。医療デバイスの留置姿勢が変化した場合、特にカニューレの穿刺部位に大きな負荷が掛かり易く、場合によってはシールが解除されて出血する虞がある。 However, the living tissue (for example, subcutaneous tissue, muscles, blood vessels, etc.) that exists around the indwelling position of the medical device deforms accordingly even in the movements and postures within the range of daily life. The initial indwelling posture of the medical device may change due to deformation of the surrounding living tissue. When the indwelling posture of the medical device changes, a large load is likely to be applied particularly to the puncture site of the cannula, and in some cases, the seal may be released and bleeding may occur.
　本発明の少なくとも一実施形態は、上述の事情に鑑みてなされたものであり、具体的には、周囲の生体組織の動きによる血管の穿刺部位に掛かる負荷を抑えて出血のリスクを低減させることができる医療器具および医療デバイスを提供することを目的としている。 At least one embodiment of the present invention has been made in view of the above-described circumstances, and specifically aims to reduce the risk of bleeding by suppressing the load applied to the puncture site of the blood vessel due to the movement of the surrounding living tissue. The purpose is to provide medical instruments and medical devices that can
　上記課題を解決するため、本実施形態に係る医療器具は、生体内において周囲の生体組織に動きが生じる位置に留置される投与装置に装着され、前記投与装置から放出される被投与物を送達部位に送達する医療器具であって、前記投与装置に接続され前記投与装置から血管を通じて前記送達部位まで延在し、穿刺部位となる前記血管の血管壁より前記投与装置側に位置する第１部分と、前記血管壁より前記送達部位側に位置する第２部分と、を有するチューブと、前記第１部分に装着され、前記第１部分の一部を保持した状態で前記生体組織の動きに追従して可動する可動部と、を備える。 In order to solve the above problems, the medical device according to the present embodiment is attached to an administration device that is indwelled in a position in which the surrounding biological tissue moves in vivo, and delivers a substance to be administered that is released from the administration device. A medical device for delivery to a site, wherein the first portion is connected to the administration device and extends from the administration device through the blood vessel to the delivery site and is positioned closer to the administration device than the vascular wall of the blood vessel serving as the puncture site. and a second portion positioned closer to the delivery site than the blood vessel wall, and attached to the first portion to follow the movement of the living tissue while holding a portion of the first portion. and a movable part that moves by
　本実施形態に係る医療デバイスは、上述した医療器具と、先端側に前記医療器具が装着され、生体内において周囲の前記生体組織に動きが生じる位置に留置される投与装置と、を備え、前記投与装置から放出された前記被投与物を、前記医療器具を介して送達部位に送達する。 A medical device according to this embodiment includes the above-described medical device, and an administration device having the medical device attached to its distal end side and indwelled at a position in which movement occurs in the surrounding biological tissue in a living body. The administered substance released from the administration device is delivered to the delivery site through the medical device.
　本発明の少なくとも一実施形態によれば、周囲の生体組織の動きによる血管の穿刺部位に掛かる負荷を抑えて出血のリスクが低減可能な医療器具および医療デバイスを提供することができる。 According to at least one embodiment of the present invention, it is possible to provide a medical instrument and a medical device capable of reducing the risk of bleeding by suppressing the load applied to the puncture site of the blood vessel due to the movement of the surrounding living tissue.
本実施形態に係る医療デバイスの全体構成を示す概略図である。It is a schematic diagram showing the whole medical device composition concerning this embodiment. 第１形態に係る医療デバイスの構成を示す図である。It is a figure which shows the structure of the medical device which concerns on a 1st form. 第１形態に係る医療デバイスを示す概略断面図である。It is a schematic sectional drawing which shows the medical device which concerns on a 1st form. 第１形態に係る医療デバイスの可動部が可動した状態を示す概略断面図である。FIG. 4 is a schematic cross-sectional view showing a state in which the movable portion of the medical device according to the first embodiment is movable; 第１形態に係る医療デバイスを生体内に留置した状態を示す概念図である。FIG. 2 is a conceptual diagram showing a state in which the medical device according to the first embodiment is placed inside the living body; 図４Ａの部分拡大断面図である。4B is a partially enlarged sectional view of FIG. 4A; FIG. 第１形態に係る医療デバイスの生体内での留置姿勢が変化した状態を示す概念図である。FIG. 4 is a conceptual diagram showing a state in which the indwelling posture of the medical device according to the first embodiment has changed in vivo. 図５Ｂの部分拡大断面図である。FIG. 5C is a partially enlarged cross-sectional view of FIG. 5B; 第２形態に係る医療デバイスの構成を示す図である。It is a figure which shows the structure of the medical device which concerns on a 2nd form. 第２形態に係る医療デバイスを示す概略断面図である。It is a schematic sectional drawing which shows the medical device which concerns on a 2nd form. 第２形態に係る医療デバイスの可動部が可動した状態を示す概略断面図である。FIG. 11 is a schematic cross-sectional view showing a state in which the movable portion of the medical device according to the second embodiment is movable; 第３形態に係る医療デバイスの構成を示す図である。It is a figure which shows the structure of the medical device which concerns on a 3rd form. 第３形態に係る医療デバイスを示す概略断面図である。FIG. 11 is a schematic cross-sectional view showing a medical device according to a third embodiment; 第３形態に係る医療デバイスの可動部が可動した状態を示す概略断面図である。FIG. 11 is a schematic cross-sectional view showing a state in which the movable portion of the medical device according to the third embodiment is movable; 第４形態に係る医療デバイスの構成を示す図である。It is a figure which shows the structure of the medical device which concerns on a 4th form. 第４形態に係る医療デバイスを示す概略断面図である。It is a schematic sectional drawing which shows the medical device which concerns on a 4th form. 第４形態に係る医療デバイスの可動部が可動した状態を示す概略断面図である。FIG. 11 is a schematic cross-sectional view showing a state in which the movable portion of the medical device according to the fourth embodiment is movable;
　以下、本発明を実施するための形態について、図面を参照しながら詳細に説明する。ここで示す実施形態は、本発明の技術的思想を具体化するために例示するものであって、本発明を限定するものではない。また、本発明の要旨を逸脱しない範囲で当業者などにより考え得る実施可能な他の形態、実施例および運用技術などは全て本発明の範囲、要旨に含まれると共に、特許請求の範囲に記載された発明とその均等の範囲に含まれる。 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.
　さらに、本明細書に添付する図面は、図示と理解のしやすさの便宜上、適宜縮尺、縦横の寸法比、形状などについて、実物から変更し模式的に表現される場合があるが、あくまで一例であって、本発明の解釈を限定するものではない。 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.
　本実施形態に係る医療デバイスにおいて、生体管腔（血管など）に挿入される側を「先端」とし、先端側と反対側（術者が把持や操作する側）を「基端」とする。また、「先端」とは、最先端から軸方向（長手方向）における一定の範囲を含み、「基端」とは、最基端から軸方向における一定の範囲を含むことを意味する。また、各図において血管壁（二点鎖線）を模式的に示しており、血管壁を境としてＹ１側は血管の外側であり、Ｙ２側は血管の内側となる。 In the medical device according to this embodiment, the side that is inserted into a biological lumen (such as a blood vessel) is defined as the "distal end", and the side opposite to the distal end side (the side that is grasped or operated by the operator) is defined as the "base end". Also, the term "distal end" means a certain range in the axial direction (longitudinal direction) from the distal end, and the term "base end" means a certain range in the axial direction from the most proximal end. In each figure, the vascular wall (a two-dot chain line) is schematically shown, and the Y1 side of the vascular wall is the outside of the blood vessel, and the Y2 side is the inside of the blood vessel.
　なお、以下の説明において、「第１」、「第２」のような序数詞を付して説明する場合は、特に言及しない限り、便宜上用いるものであって何らかの順序を規定するものではない。 It should be noted that, in the following description, when describing with ordinal numbers such as "first" and "second", unless otherwise specified, it is used for convenience and does not prescribe any order.
　［デバイス概要］
　まず、本実施形態に係る医療デバイス１の概要について説明する。医療デバイス１は、図１に示すように、概説すると、収容する所定の被投与物Ｘを投与可能な投与装置１０と、投与装置１０に接続されて投与装置１０から放出された被投与物Ｘを目的の送達部位まで送達する医療器具２０と、で構成される。医療デバイス１は、生体内に留置され、医療器具２０を血管Ｂｖに穿通して経血管的に送達部位に被投与物Ｘを送達する。 [Device Overview]
First, an overview of the medical device 1 according to this embodiment will be described. The medical device 1, as shown in FIG. to the intended delivery site. The medical device 1 is left in the living body, penetrates the blood vessel Bv with the medical device 20, and transvascularly delivers the administered substance X to the delivery site.
　投与装置１０に収容される被投与物Ｘは、送達部位に対して所定の効果発現が得られ、かつ装置から放出可能な流体組成物である。被投与物Ｘは、一例として、所定の疾患の治療を目的とする薬剤（液剤）である。薬剤は、薬物を含む。薬物は、任意の生理学的にまたは薬理学的に活性な物質であり、特にヒトまたは動物の体に送達されることが知られるものであり得る。薬剤は、末梢神経、アドレナリン受容体、コリン作動性受容体、骨格筋、心臓血管系、平滑筋、血管系、シナプス（ｓｙｎｏｐｔｉｃ）部位、神経交換器可動部位、内分泌およびホルモン系、免疫系、生殖器系、骨格系、局所ホルモン系、消化器および排泄系、ヒスタミン系、または中枢神経系に作用する薬物を含むが、これらに限定されない。また、薬物は、感染症、慢性痛、糖尿病、自己免疫疾患、内分泌疾患、代謝異常、およびリウマチ性疾患の治療に用いられる薬物を含むが、これらに限定されない。さらに、薬物は、ペプチド、タンパク質、ポリペプチド（例えば、酵素、ホルモン、サイトカイン）、核酸、オリゴヌクレオチド、ウイルス、ウイルスベクター、プラスミド、核タンパク質、多糖、糖タンパク質、リポタンパク質、細胞、ステロイド、鎮痛薬、局所麻酔薬、抗生物質製剤、抗炎症性コルチコステロイド、眼薬、製薬学的用途の他の小分子、またはこれらの種の合成アナログ、およびこれらの混合物などを含むが、これらに限定されない。被投与物Ｘは、具体的には、スピンラザ、バクロフェン、ヒュンタラーゼ、ブリニューラなどを使用することができる。 The object X to be administered contained in the administration device 10 is a fluid composition that exerts a predetermined effect on the delivery site and can be released from the device. The administered object X is, for example, a drug (liquid drug) intended to treat a predetermined disease. Drugs 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 mobile sites, endocrine and hormonal system, immune system, reproductive organs system, skeletal system, local hormonal system, digestive and excretory system, histamine system, or central nervous system. Drugs also 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. . Specifically, spinraza, baclofen, hyuntalase, brineura, and the like can be used as the administered substance X.
　＜投与装置＞
　投与装置１０は、被投与物Ｘを収容する収容部１１と、収容部１１に収容された被投与物Ｘを放出する放出機構１２と、を少なくとも備える。投与装置１０は、被投与物Ｘを収容し、医療器具２０と接続された状態で生体（一例として、皮下組織Ｓ）内に留置される。 <Administration device>
The administration device 10 includes at least a storage section 11 that stores a subject X to be administered, and a release mechanism 12 that releases the subject X stored in the storage section 11 . The administration device 10 accommodates the object X to be administered, and is left in a living body (subcutaneous tissue S as an example) while being connected to the medical device 20 .
　収容部１１は、被投与物Ｘを収容するために投与装置１０の内部に形成された空間である。収容部１１は、投与装置１０の筐体に形成された投与用の開口部を介して外部（具体的には医療器具２０）と連通している。被投与物Ｘは、放出機構１２の駆動により開口部から放出される。 The containing portion 11 is a space formed inside the administration device 10 to contain the substance X to be administered. The container 11 communicates with the outside (specifically, the medical device 20 ) via an administration opening formed in the housing of the administration device 10 . The object X to be administered is released from the opening by driving the release mechanism 12 .
　放出機構１２は、被投与物Ｘを投与期間、所定の投与条件（投与タイミング、投与時間、投与量など）に基づき被投与物Ｘの投与動作が制御可能に構成される。放出機構１２は、上記のような被投与物Ｘの投与に関する制御機能を有していれば、被投与物Ｘを放出する装置構成や駆動に必要な動力源などは特に限定されない。放出機構１２は、例えば収容部１１に収容された被投与物Ｘを押し出す押出部と、押出部を所定条件で駆動させる駆動部を備えた構成とすることができる。また、放出機構１２は、駆動部の動力源として、例えば生体内の水分、小型電池、電磁波のような駆動部の駆動に必要な動力が発生し得るものを適用することができる。 The release mechanism 12 is configured to be able to control the administration operation of the substance X to be administered based on the administration period of the substance X and predetermined administration conditions (administration timing, administration time, dose, etc.). As long as the release mechanism 12 has a control function related to the administration of the object X to be administered as described above, the configuration of the device for releasing the object to be administered X, the power source required for driving, etc. are not particularly limited. The release mechanism 12 can be configured to include, for example, an extrusion section that pushes out the administration subject X accommodated in the accommodation section 11, and a driving section that drives the extrusion section under predetermined conditions. In addition, the release mechanism 12 can use, as a power source for the drive section, a source capable of generating the power required to drive the drive section, such as moisture in the body, a small battery, or electromagnetic waves.
　投与装置１０は、生体内に留置され、被投与物Ｘを長期間に亘って持続的に徐放可能な持続投与装置としてよい。持続投与装置は、内腔を有する本体部と、本体部の基端側に配置される液体透過部と、液体透過部よりも上流側に配置され液体透過部を透過した液体（体液中の水分）により膨張して栓体を下流側へ押圧する押圧部（浸透圧エンジン）と、本体部の内腔を液密に摺動可能な栓体と、栓体の摺動によって押し出された被投与物Ｘを外部に放出する放出部と、を備えた浸透圧方式による持続的な投与が可能な装置であってよい。このような構成を備えた持続投与装置において、放出機構１２の駆動部は、液体透過部と押圧部で構成され、押出部は、栓体で構成され、駆動部の動力源は、体液中の水分となる。 The administration device 10 may be a continuous administration device that is left in the body and is capable of sustainably releasing the object X over a long period of time. The continuous administration device includes a body portion having a lumen, a liquid permeable portion disposed on the proximal end side of the body portion, and a liquid (moisture in body fluid) disposed upstream of the liquid permeable portion and permeating the liquid permeable portion. ) that expands and pushes the stopper downstream (osmotic engine), the stopper that can slide liquid-tightly in the lumen of the main body, and the administered substance pushed out by the sliding of the stopper. It may be a device capable of continuous administration by an osmotic method, which has a release part for releasing the substance X to the outside. In the continuous administration device having such a configuration, the driving portion of the release mechanism 12 is composed of the liquid permeable portion and the pressing portion, the pushing portion is composed of the plug, and the power source of the driving portion is the liquid in the body fluid. becomes water.
　＜医療器具＞
　医療器具２０は、概説すると、投与装置１０に接続されるチューブ２１と、チューブ２１の血管Ｂｖに対する穿刺姿勢を維持するようにチューブ２１の一部を保持した状態で生体組織の動きに追従して可動する可動部２２を備える。 <Medical Instruments>
Generally speaking, the medical device 20 follows the movement of a tube 21 connected to the administration device 10 and the body tissue while part of the tube 21 is held so as to maintain the posture of the tube 21 puncturing the blood vessel Bv. A movable part 22 is provided.
　チューブ２１は、投与装置１０の先端側に接続され、投与装置１０から血管Ｂｖを通じて送達部位まで延在する長尺な管状部材である。チューブ２１は、第１部分２１１の基端から第２部分２１２の先端まで連通する内腔を有する。 The tube 21 is a long tubular member connected to the distal end of the administration device 10 and extending from the administration device 10 through the blood vessel Bv to the delivery site. The tube 21 has a lumen communicating from the proximal end of the first portion 211 to the distal end of the second portion 212 .
　チューブ２１は、血管壁Ｂｗを境として投与装置１０側に位置する第１部分２１１と、血管壁Ｂｗを境として送達部位側に位置する第２部分２１２と、を有する。チューブ２１のうち、第１部分２１１は血管Ｂｖの外側で生体内に留置され、第２部分２１２は血管壁Ｂｗを穿通して血管Ｂｖ内に挿入される。第２部分２１２は、先端が血管Ｂｖを介して先端が送達部位まで挿入され、投与装置１０から放出された被投与物Ｘを送達部位に送達する。また、チューブ２１の第１部分２１１のうち、可動部２２が装着される部分は、第３部分２１３となる。すなわち、第３部分２１３は、血管壁Ｂｗを境にチューブ２１を区切った２部分のうち、第１部分２１１の一部を構成する。 The tube 21 has a first portion 211 located on the administration device 10 side with the blood vessel wall Bw as a boundary, and a second portion 212 located on the delivery site side with the blood vessel wall Bw as a boundary. A first portion 211 of the tube 21 is left in the living body outside the blood vessel Bv, and a second portion 212 is inserted through the blood vessel wall Bw into the blood vessel Bv. The tip of the second portion 212 is inserted through the blood vessel Bv to the delivery site, and delivers the administered substance X released from the administration device 10 to the delivery site. Further, the portion of the first portion 211 of the tube 21 to which the movable portion 22 is attached becomes the third portion 213 . That is, the third portion 213 constitutes part of the first portion 211 of the two portions that separate the tube 21 with the blood vessel wall Bw as a boundary.
　チューブ２１と投与装置１０との接続形態は、投与装置１０の先端に形成したネジ山（またはネジ溝）とチューブ２１の基端に形成したネジ溝（またはネジ山）とを螺合する形態、投与装置１０の先端とチューブ２１の基端とを圧入嵌合（必要に応じて接着剤も併用）する形態、スナップフィットのような係合方式を用いた形態など、生体内に留置した際に投与装置１０とチューブ２１との接続が解除されない形態であれば特に限定されない。さらに、投与終了後に新たな投与装置１０に付け替えられる形態がより好ましい。 The form of connection between the tube 21 and the administration device 10 is a form in which a thread (or thread groove) formed at the distal end of the administration device 10 and a thread groove (or thread) formed at the proximal end of the tube 21 are screwed together. When the distal end of the administration device 10 and the proximal end of the tube 21 are press-fitted (using an adhesive if necessary), or the engagement method such as a snap fit is used, the There is no particular limitation as long as the connection between the administration device 10 and the tube 21 is not released. Furthermore, a form in which a new administration device 10 can be used after administration is more preferable.
　可動部２２は、チューブ２１の第１部分２１１に装着され、第１部分２１１および第２部分２１２との連通を維持しつつ少なくとも第２部分２１２の血管Ｂｖへの穿刺姿勢が維持されるように、第１部分２１１の一部を保持した状態で生体組織の動きに追従して可動する。より好ましくは、可動部２２は、第１部分２１１における可動部２２の装着部分に相当する第３部分２１３を覆って保持した状態で第１部分２１１に装着され、第３部分２１３よりも先端側の第１部分２１１の留置姿勢および第２部分２１２の血管Ｂｖへの穿刺姿勢が維持されるように、生体組織の動きによる第３部分２１３および第３部分２１３よりも基端側の第１部分２１１の姿勢変化に追従して可動する。 The movable portion 22 is attached to the first portion 211 of the tube 21, and maintains communication with the first portion 211 and the second portion 212, and at least the second portion 212 is maintained in a posture of puncturing the blood vessel Bv. , while holding a part of the first portion 211, it moves following the movement of the living tissue. More preferably, the movable part 22 is mounted on the first part 211 in a state of covering and holding the third part 213 corresponding to the mounting part of the movable part 22 in the first part 211 , and is located on the tip side of the third part 213 . so that the indwelling attitude of the first part 211 and the puncturing attitude of the second part 212 into the blood vessel Bv are maintained, the third part 213 and the first part closer to the proximal end than the third part 213 are moved by the movement of the living tissue. 211 can be moved by following the posture change.
　可動部２２は、チューブ２１の第１部分２１１と第２部分２１２との連通を維持しつつ、投与装置１０やチューブ２１が周囲の生他組織の動きよる姿勢（例えば、投与装置１０の留置姿勢、チューブ２１の血管Ｂｖに対する穿刺姿勢や生体内での留置姿勢）の変化を吸収するように、生体組織の動きに追従して可動する。可動部２２が生体組織の動きに追従して可動することで、第３部分２１３よりも先端側（送達部位側）の第１部分２１１および第２部分２１２は、生体組織の動きの影響を受け難くなる。そのため、医療器具２０は、チューブ２１の変位による血管Ｂｖに対する負担を低減することができる。 The movable part 22 maintains communication between the first portion 211 and the second portion 212 of the tube 21, and allows the administration device 10 and the tube 21 to assume a posture (for example, an indwelling posture of the administration device 10) according to the movement of surrounding living tissue. , the posture of puncturing the blood vessel Bv of the tube 21 and the posture of indwelling in the living body), it moves following the movement of the living tissue. Since the movable portion 22 moves following the movement of the living tissue, the first portion 211 and the second portion 212 on the distal side (delivery site side) of the third portion 213 are affected by the movement of the living tissue. it gets harder. Therefore, the medical device 20 can reduce the burden on the blood vessel Bv due to displacement of the tube 21 .
　また、可動部２２は、周囲の生体組織の動きによる第３部分２１３の内腔の潰れを防止するように、第３部分２１３やその周囲を覆って装着することができる。これにより、チューブ２１は、周囲の生体組織による第３部分２１３の潰れ周囲の生体組織による第３部分２１３の潰れ、チューブ２１の連通状態が維持される。 In addition, the movable part 22 can be mounted so as to cover the third part 213 and its surroundings so as to prevent the lumen of the third part 213 from collapsing due to the movement of the surrounding living tissue. As a result, the third portion 213 of the tube 21 is crushed by the surrounding living tissue, and the communication state of the tube 21 is maintained.
　チューブ２１は、周囲の生体組織の動きに抗して座屈が抑制される程度の剛性が得られる医療分野で適用可能な材料であれば、特に限定されない。チューブ２１（第１部分２１１および第２部分２１２）の構成材料は、一例として、ポリオレフィン（例えば、ポリエチレン、ポリプロピレン、ポリブテン、エチレン－プロピレン共重合体、エチレン－酢酸ビニル共重合体、アイオノマー、またはこれら二種以上の混合物など）、ポリオレフィンエラストマー、ポリオレフィンの架橋体、ポリ塩化ビニル、ポリアミド、ポリアミドエラストマー、ポリエステル、ポリエステルエラストマー、ポリウレタン、ポリウレタンエラストマー、フッ素系樹脂、ポリカーボネート、ポリスチレン、ポリアセタール、ポリイミド、ポリエーテルイミド、芳香族ポリエーテルケトンなどの高分子材料またはこれらの混合物のような樹脂材料、形状記憶合金、ステンレス、タンタル、チタン、プラチナ、金、タングステンのような金属材料を好適に用いることができる。 The tube 21 is not particularly limited as long as it is a material that can be applied in the medical field and has sufficient rigidity to suppress buckling against the movement of the surrounding living tissue. The constituent material of the tube 21 (the first portion 211 and the second portion 212) is, for example, polyolefin (eg, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or these mixture of two or more), polyolefin elastomer, crosslinked polyolefin, polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polyurethane elastomer, fluorine resin, polycarbonate, polystyrene, polyacetal, polyimide, polyetherimide , polymer materials such as aromatic polyetherketone, resin materials such as mixtures thereof, shape memory alloys, metal materials such as stainless steel, tantalum, titanium, platinum, gold, and tungsten.
　また、チューブ２１の第３部分２１３については、第１部分２１１と同様の材料で構成できるが、投与装置１０やチューブ２１の姿勢変化に伴う可動部２２の動きに対し、より柔軟に追従可能とするため、第３部分２１３以外の第１部分２１１や第２部分２１２よりも柔軟性を有する材料を適用することもできる。医療器具２０は、第３部分２１３を第１部分２１１や第２部分２１２よりも柔軟性を有する材料で構成したとしても、第３部分２１３を覆った状態で可動部２２を装着させることで、周囲の生体組織による内腔の潰れが防止できる。 In addition, the third portion 213 of the tube 21 can be made of the same material as the first portion 211, but can more flexibly follow the movement of the movable portion 22 accompanying the change in posture of the administration device 10 and the tube 21. Therefore, a material other than the third portion 213, which is more flexible than the first portion 211 and the second portion 212, can be applied. Even if the third portion 213 of the medical device 20 is made of a material that is more flexible than the first portion 211 and the second portion 212, by attaching the movable portion 22 while covering the third portion 213, Collapse of the lumen due to surrounding living tissue can be prevented.
　次に、医療デバイス１の具体的な形態について説明する。医療デバイス１Ａ～医療デバイス１Ｄは、下記第１形態～第４形態に示す構成とすることができる。なお、以下に説明する各形態は、あくまで一例であって医療デバイス１の構成要素や作用を限定するものではない。また、以下に説明する第１形態～第４形態は、前述した実施形態と同一の機能を有する構成要件については詳細な説明を省略し、特に言及しない構成、部材、および使用方法などについては、前述した実施形態と同様のものとしてよい。 Next, a specific form of the medical device 1 will be described. The medical device 1A to medical device 1D can be configured as shown in the following first to fourth modes. It should be noted that each form described below is merely an example and does not limit the components and actions of the medical device 1 . In addition, in the first to fourth embodiments described below, detailed descriptions of components having the same functions as those of the above-described embodiments are omitted, and configurations, members, and methods of use that are not particularly mentioned are It may be similar to the embodiment described above.
　医療デバイス１Ａ～医療デバイス１Ｄは、可動部２２Ａ～可動部２２Ｄの構成や作用がそれぞれ異なり、その他の構成（投与装置１０Ａ～投与装置１０Ｄ、医療器具２０Ａ～医療器具２０Ｄのチューブ２１など）については、前述した投与装置１０、チューブ２１と同様に構成することができる。そのため、以下の説明では、主として各形態の特徴要件となる可動部２２Ａ～可動部２２Ｄの構成および作用について言及することとする。 The medical devices 1A to 1D differ in the configuration and action of the movable portions 22A to 22D, respectively, and other configurations (administration devices 10A to 10D, tubes 21 of the medical devices 20A to 20D, etc.) , can be configured in the same manner as the administration device 10 and the tube 21 described above. Therefore, in the following description, the configurations and actions of the movable parts 22A to 22D, which are characteristic requirements of each form, will be mainly referred to.
　［第１形態］
　第１形態に係る医療デバイス１Ａについて説明する。医療デバイス１Ａは、図２～図３Ｂに示すように、投与装置１０Ａと、医療器具２０Ａと、を備える。 [First form]
A medical device 1A according to the first embodiment will be described. The medical device 1A comprises an administration device 10A and a medical instrument 20A, as shown in FIGS. 2-3B.
　医療器具２０Ａの可動部２２Ａは、チューブ２１Ａの第３部分２１３Ａの基端側に装着され、第３部分２１３Ａよりも基端側の第１部分２１１Ａの姿勢変化に伴う回転中心となる第１可動部２２１Ａａと、第３部分２１３Ａの先端側に装着され、第１可動部２２１Ａａの一部を覆いながら第１可動部２２１Ａａを回転可能に保持する第２可動部２２１Ａｂと、を備える。第１可動部２２１Ａａは、第２可動部２２１Ａｂに対して回転可能に嵌入される。 The movable portion 22A of the medical device 20A is mounted on the proximal side of the third portion 213A of the tube 21A, and serves as the center of rotation when the posture of the first portion 211A on the proximal side of the third portion 213A changes. and a second movable portion 221Ab attached to the distal end side of the third portion 213A and rotatably holding the first movable portion 221Aa while covering a part of the first movable portion 221Aa. The first movable portion 221Aa is rotatably fitted into the second movable portion 221Ab.
　可動部２２Ａは、第１可動部２２１Ａａが回転可能に保持される構成を有する。第１可動部２２１Ａａは、投与装置１０Ａやチューブ２１Ａの姿勢変化に追従するように第３部分２１３Ａの一部を保持した状態で回転し、これらの姿勢変化を吸収することができる。したがって、医療器具２０Ａは、チューブ２１Ａの姿勢（詳細には、第３部分２１３Ａよりも先端側の第１部分２１１Ａの留置姿勢や第２部分２１２Ａの血管Ｂｖに対する穿刺姿勢）を維持することができる。 The movable part 22A has a configuration in which the first movable part 221Aa is rotatably held. The first movable portion 221Aa rotates while holding part of the third portion 213A so as to follow changes in posture of the administration device 10A and the tube 21A, and can absorb these changes in posture. Therefore, the medical device 20A can maintain the posture of the tube 21A (more specifically, the placement posture of the first portion 211A on the distal side of the third portion 213A and the puncture posture of the second portion 212A with respect to the blood vessel Bv). .
　第１可動部２２１Ａａは、内部空間を有する略中空球体をなす。第１可動部２２１Ａａは、一部に内部空間と連通する開口部２２２Ａａが形成されるとともに、開口部２２２Ａａと対向する位置にチューブ２１Ａの第３部分２１３Ａが挿通される挿通孔２２３Ａａが形成される。第１可動部２２１Ａａは、開口部２２２Ａａを第２可動部２２１Ａｂの開口部２２２Ａｂに向けた状態で第２可動部２２１Ａｂの内部空間に嵌入される。 The first movable part 221Aa is a substantially hollow sphere with an internal space. The first movable portion 221Aa is partially formed with an opening 222Aa that communicates with the internal space, and is formed with an insertion hole 223Aa at a position facing the opening 222Aa through which the third portion 213A of the tube 21A is inserted. . The first movable portion 221Aa is fitted into the internal space of the second movable portion 221Ab with the opening 222Aa facing the opening 222Ab of the second movable portion 221Ab.
　第２可動部２２１Ａｂは、第１可動部２２１Ａａが嵌入可能な内部空間を有する略中空球体をなす。第２可動部２２１Ａｂは、一部に内部空間と連通する開口部２２２Ａｂが形成されるとともに、開口部２２２Ａｂと対向する位置にチューブ２１Ａの第３部分２１３Ａが挿通される挿通孔２２３Ａｂが形成される。第２可動部２２１Ａｂは、開口部２２２Ａａを開口部２２２Ａｂに向けた状態で内部空間に挿入される第１可動部２２１Ａａを、回転可能に保持する。 The second movable part 221Ab is a substantially hollow sphere having an internal space into which the first movable part 221Aa can be fitted. The second movable portion 221Ab is partially formed with an opening 222Ab that communicates with the internal space, and is formed with an insertion hole 223Ab at a position facing the opening 222Ab, through which the third portion 213A of the tube 21A is inserted. . The second movable portion 221Ab rotatably holds the first movable portion 221Aa that is inserted into the internal space with the opening 222Aa facing the opening 222Ab.
　第２可動部２２１Ａｂの開口部２２２Ａｂは、第１可動部２２１Ａａが回転する際に離脱しない程度の開口サイズ（開口径）とするのが好ましい。また、第１可動部２２１Ａａを第２可動部２２１Ａｂに嵌入した状態で第１可動部２２１Ａａを回転させた際、第１可動部２２１Ａａと第２可動部２２１Ａｂとの間に周囲の生体組織が進入しないように、第１可動部２２１Ａａの外形サイズ（外径）と第２可動部２２１Ａｂの内部空間サイズ（内径）は規定される。この際、第１可動部２２１Ａａの外周面と第２可動部２２１Ａｂの内周面とが接触するように規定してもよいし、摺動抵抗を考慮して周囲の生体組織を引き込まない程度の隙間が空くように規定してもよい。 The opening 222Ab of the second movable part 221Ab preferably has an opening size (opening diameter) that does not come off when the first movable part 221Aa rotates. Also, when the first movable portion 221Aa is rotated in a state where the first movable portion 221Aa is fitted in the second movable portion 221Ab, the surrounding living tissue enters between the first movable portion 221Aa and the second movable portion 221Ab. The outer size (outer diameter) of the first movable portion 221Aa and the inner space size (inner diameter) of the second movable portion 221Ab are defined so as to prevent this. At this time, the outer peripheral surface of the first movable portion 221Aa and the inner peripheral surface of the second movable portion 221Ab may be defined to be in contact with each other. It may be defined so that there is a gap.
　チューブ２１Ａの第３部分２１３Ａは、先端側から基端側に向かう所定長さだけ開口部２２２Ａａから突出した状態で先端が挿通孔２２３Ａｂの内周面に固着される。また、第３部分２１３Ａは、基端側が挿通孔２２３Ａａの内周面に固着される。つまり、第３部分２１３Ａは、先端側が第２可動部２２１Ａｂに保持され、基端側が第１可動部２２１Ａａに保持されるが、その他の部位については固定されないフリーな状態となる。これにより、チューブ２１Ａの第１部分２１１Ａなどの姿勢変化に伴い、第１可動部２２１Ａａが回転したとしても、第３部分２１３Ａは、柔軟に変形できるため、第３部分２１３Ａの内腔形状は維持され、チューブ２１Ａの座屈が防止される。 The tip of the third portion 213A of the tube 21A is fixed to the inner peripheral surface of the insertion hole 223Ab while protruding from the opening 222Aa by a predetermined length from the tip side to the base end side. The base end side of the third portion 213A is fixed to the inner peripheral surface of the insertion hole 223Aa. That is, the third portion 213A is held by the second movable portion 221Ab at the distal end and held by the first movable portion 221Aa at the proximal end, but the other portions are in a free state in which they are not fixed. As a result, even if the first movable portion 221Aa rotates as the posture of the first portion 211A of the tube 21A changes, the third portion 213A can be flexibly deformed, so that the lumen shape of the third portion 213A is maintained. and buckling of the tube 21A is prevented.
　次に、医療デバイス１Ａを生体内に留置した際の態様について説明する。 Next, a mode when the medical device 1A is left in the living body will be described.
　医療デバイス１Ａは、図４Ａや図４Ｂに示すように、生体内の留置位置として頚部近傍の皮下組織Ｓとし、チューブ２１Ａを穿刺する血管Ｂｖを頸静脈とする。なお、医療デバイス１Ａの留置位置は、被投与物Ｘの送達部位の位置によってチューブ２１Ａを穿刺する血管Ｂｖが決まるため、図４Ａ、図４Ｂに示す頚部近傍に限定されない。医療デバイス１Ａの留置位置や穿刺対象となる血管Ｂｖは、被投与物Ｘの送達部位の位置に応じて、適宜決定することができる。 As shown in FIGS. 4A and 4B, the medical device 1A is placed in the subcutaneous tissue S near the neck as an indwelling position in the living body, and the blood vessel Bv through which the tube 21A is punctured is the jugular vein. Note that the indwelling position of the medical device 1A is not limited to the vicinity of the neck shown in FIGS. 4A and 4B, since the blood vessel Bv through which the tube 21A is punctured is determined by the position of the delivery site of the object X to be administered. The indwelling position of the medical device 1A and the blood vessel Bv to be punctured can be appropriately determined according to the position of the delivery site of the object X to be administered.
　図４Ａ、図４Ｂに示すように、医療デバイス１Ａは、被投与物Ｘの送達部位の位置に基づき穿刺対象となる頸静脈が走行する頚部近傍の皮下組織Ｓに留置される。医療デバイス１Ａを留置する場合、まず留置位置近傍の皮膚を切開して頸静脈（血管Ｂｖ）を露出させ、その血管Ｂｖにチューブ２１Ａを穿刺して導入する。チューブ２１Ａは、周知の導入方法により血管Ｂｖに穿刺して導入することができる。投与装置１０Ａは、チューブ２１Ａと接続された状態で、皮下組織Ｓ内に留置（若しくは頸静脈に縫合または接着剤により固定）される。 As shown in FIGS. 4A and 4B, the medical device 1A is indwelled in the subcutaneous tissue S in the vicinity of the neck where the jugular vein to be punctured runs based on the position of the delivery site of the object X to be administered. When the medical device 1A is to be indwelled, first, the skin near the indwelling position is incised to expose the jugular vein (blood vessel Bv), and the tube 21A is introduced by puncturing the blood vessel Bv. The tube 21A can be introduced by puncturing the blood vessel Bv by a well-known introduction method. The administration device 10A is left in the subcutaneous tissue S (or fixed to the jugular vein with suture or adhesive) while being connected to the tube 21A.
　医療デバイス１Ａは、図５Ａ、図５Ｂに示すように、周囲の生体組織の動きにより例えば投与装置１０Ａの留置姿勢が留置当初から変化したとする。医療デバイス１Ａは、医療器具２０Ａを備えているため、可動部２２Ａの第１可動部２２１Ａａを回転中心として可動して投与装置１０Ａの姿勢変化を吸収することができる。そのため、医療デバイス１Ａは、生体組織の動きにより投与装置１０Ａなどの姿勢が変化したとしても、チューブ２１Ａの第３部分２１３Ａよりも先端側の第１部分２１１Ａの留置姿勢や第２部分２１２Ａの血管Ｂｖに対する穿刺姿勢を維持することができる。 　As shown in FIGS. 5A and 5B, it is assumed that the indwelling posture of the administration apparatus 10A, for example, has changed from the beginning of indwelling due to the movement of the surrounding living tissue. Since the medical device 1A includes the medical instrument 20A, it can move about the first movable portion 221Aa of the movable portion 22A as the center of rotation, and can absorb changes in posture of the administration device 10A. Therefore, even if the posture of the administration device 10A or the like changes due to the movement of the living tissue, the medical device 1A can maintain the placement posture of the first portion 211A on the distal side of the third portion 213A of the tube 21A and the blood vessel of the second portion 212A. The puncture posture with respect to Bv can be maintained.
　このように、医療器具２０Ａは、チューブ２１Ａの第３部分２１３Ａの基端側に装着され、第３部分２１３Ａよりも基端側の第１部分２１１Ａの姿勢変化に伴う回転中心となる第１可動部２２１Ａａと、第３部分２１３Ａの先端側に装着され、第１可動部２２１Ａａの一部を覆いながら第１可動部２２１Ａａを回転可能に保持する第２可動部２２１Ａｂと、で構成される可動部２２Ａを備える。可動部２２Ａは、図３Ｂや図５Ｂに示すように、医療デバイス１Ａの周囲の生体組織の動きにより医療デバイス１Ａの構成要素（例えば投与装置１０Ａ）の留置姿勢が留置当初から変化したとしても、第１可動部２２１Ａａを回転中心として可動して投与装置１０Ａの姿勢変化を吸収することができる。そのため、チューブ２１Ａの第３部分２１３Ａよりも先端側の第１部分２１１Ａの留置姿勢や第２部分２１２Ａの血管Ｂｖに対する穿刺姿勢は、留置当初の状態が維持される。したがって、医療器具２０Ａを備える医療デバイス１Ａは、生体内に留置した後に周囲の生体組織が動いたとしても、血管Ｂｖの穿刺部位に掛かる負荷が抑制されるため、穿刺部位のシール解除による出血のリスクを低減することができる。 In this way, the medical device 20A is attached to the proximal side of the third portion 213A of the tube 21A, and is the first movable body that serves as the center of rotation as the posture of the first portion 211A, which is closer to the proximal side than the third portion 213A, changes. A movable portion composed of a portion 221Aa and a second movable portion 221Ab attached to the distal end side of the third portion 213A and rotatably holding the first movable portion 221Aa while covering a part of the first movable portion 221Aa. 22A. As shown in FIG. 3B and FIG. 5B, the movable part 22A can maintain the movement of the body tissue around the medical device 1A even if the placement posture of the components of the medical device 1A (for example, the administration device 10A) changes from the initial placement. It is possible to move the first movable portion 221Aa as the center of rotation to absorb changes in posture of the administration device 10A. Therefore, the indwelling posture of the first portion 211A on the distal side of the third portion 213A of the tube 21A and the puncturing posture of the second portion 212A with respect to the blood vessel Bv are maintained in the initial state of indwelling. Therefore, the medical device 1A including the medical instrument 20A suppresses the load applied to the puncture site of the blood vessel Bv even if the surrounding living tissue moves after being placed in the living body. Risk can be reduced.
　［第２形態］
　次に、第２形態に係る医療デバイス１Ｂについて説明する。 [Second form]
Next, a medical device 1B according to the second embodiment will be described.
　第２形態の医療デバイス１Ｂは、医療器具２０Ｂが、第１可動部２２１Ｂａを保持した状態の第２可動部２２１Ｂｂを覆うカバー部２３０を具備する点で、第１形態の医療デバイス１Ａと相違する。したがって、医療デバイス１Ｂを構成する投与装置１０Ｂ、医療器具２０Ｂのチューブ２１Ｂおよび可動部２２Ｂ（第１可動部２２１Ｂａ、第２可動部２２１Ｂｂ）は、第１形態の医療デバイス１Ａの対応する各部と構成や機能が一致する。なお、説明の便宜上、第２形態に係る医療デバイス１Ｂは、第１形態の医療デバイス１Ａと同一構成であっても異なる符号を付している。 The medical device 1B of the second embodiment differs from the medical device 1A of the first embodiment in that the medical device 20B includes a cover portion 230 that covers the second movable portion 221Bb holding the first movable portion 221Ba. . Therefore, the administration device 10B, the tube 21B, and the movable portion 22B (the first movable portion 221Ba and the second movable portion 221Bb) of the medical device 20B, which constitute the medical device 1B, are configured with the corresponding portions of the medical device 1A of the first embodiment. and functions match. For convenience of explanation, the medical device 1B according to the second embodiment has the same configuration as the medical device 1A according to the first embodiment, but is given a different reference numeral.
　医療デバイス１Ｂは、図６、図７Ａ、図７Ｂの何れかに示すように、投与装置１０Ｂと、医療器具２０Ｂと、を備える。 The medical device 1B includes an administration device 10B and a medical instrument 20B, as shown in any of FIGS. 6, 7A, and 7B.
　医療器具２０Ｂの可動部２２Ｂは、チューブ２１Ｂの第３部分２１３Ｂの基端側に装着され、第３部分２１３Ｂよりも基端側の第１部分２１１Ｂの姿勢変化に伴う回転中心となる第１可動部２２１Ｂａと、第３部分２１３Ｂの先端側に装着され、第１可動部２２１Ｂａの一部を覆いながら第１可動部２２１Ｂａを回転可能に保持する第２可動部２２１Ｂｂと、第１可動部２２１Ｂａを保持した第２可動部２２１Ｂｂを覆うカバー部２３０を備える。 The movable portion 22B of the medical device 20B is mounted on the proximal side of the third portion 213B of the tube 21B, and serves as the center of rotation when the posture of the first portion 211B on the proximal side of the third portion 213B changes. A portion 221Ba, a second movable portion 221Bb attached to the tip side of the third portion 213B and rotatably holding the first movable portion 221Ba while covering a part of the first movable portion 221Ba, and the first movable portion 221Ba. A cover portion 230 is provided to cover the held second movable portion 221Bb.
　カバー部２３０は、略中空球体をなす。カバー部２３０は、一部に第１可動部２２１Ｂａに接続されるチューブ２１Ｂの第３部分２１３Ｂよりも基端側の第１部分２１１Ｂの姿勢変化を許容する開口部２３１が形成される。開口部２３１は、第１可動部２２１Ｂａの回転によるチューブ２１Ｂの第３部分２１３Ｂよりも基端側の第１部分２１１Ｂの姿勢変化を阻害しない程度の開口サイズ（開口径）に規定される。 The cover part 230 forms a substantially hollow sphere. The cover portion 230 is partially formed with an opening portion 231 that allows the attitude change of the first portion 211B closer to the base end than the third portion 213B of the tube 21B connected to the first movable portion 221Ba. The opening portion 231 is defined to have an opening size (opening diameter) that does not hinder the posture change of the first portion 211B closer to the proximal end than the third portion 213B of the tube 21B due to the rotation of the first movable portion 221Ba.
　また、カバー部２３０は、第２可動部２２１Ｂｂに挿通されるチューブ２１Ｂの第３部分２１３Ｂが挿通される挿通孔２３２が形成される。挿通孔２３２の内周面は、第３部分２１３Ｂの外周面と接触していてもよいし、第３部分２１３Ｂとの間に多少の隙間が空いていてもよい。 Further, the cover portion 230 is formed with an insertion hole 232 through which the third portion 213B of the tube 21B that is inserted through the second movable portion 221Bb is inserted. The inner peripheral surface of the insertion hole 232 may be in contact with the outer peripheral surface of the third portion 213B, or may have some gap between it and the third portion 213B.
　カバー部２３０は、第１可動部２２１Ｂａが回転した際に周囲の生体組織が第１可動部２２１Ｂａと第２可動部２２１Ｂｂとの間の隙間に引き込まれることを防止するための部材である。そのため、カバー部２３０は、第１可動部２２１Ｂａと第２可動部２２１Ｂｂとの嵌合状態において、少なくとも第１可動部２２１Ｂａと第２可動部２２１Ｂｂとの重なり領域を覆うように構成される。 The cover part 230 is a member for preventing the surrounding living tissue from being pulled into the gap between the first movable part 221Ba and the second movable part 221Bb when the first movable part 221Ba rotates. Therefore, the cover portion 230 is configured to cover at least the overlapping region between the first movable portion 221Ba and the second movable portion 221Bb in the fitted state of the first movable portion 221Ba and the second movable portion 221Bb.
　カバー部２３０の構成材料は、チューブ２１Ｂと同様の材料で構成するなど、生体適合性を有する材料であれば特に限定されない。 The constituent material of the cover part 230 is not particularly limited as long as it is a material having biocompatibility, such as a material similar to that of the tube 21B.
　このように、医療器具２０Ｂは、第１可動部２２１Ｂａと、第２可動部２２１Ｂｂと、第１可動部２２１Ｂａを保持した状態の第２可動部２２１Ｂｂを覆うカバー部２３０と、で構成された可動部２２Ｂを備える。可動部２２Ｂは、図７Ｂに示すように、医療デバイス１Ｂの周囲の生体組織の動きにより医療デバイス１Ｂの構成要素（例えば投与装置１０Ｂ）の留置姿勢が留置当初から変化したとしても、第１可動部２２１Ｂａを回転中心として可動して投与装置１０Ｂの姿勢変化を吸収することができる。そのため、チューブ２１Ｂの第３部分２１３Ｂよりも先端側の第１部分２１１Ｂの留置姿勢や第２部分２１２Ｂの血管Ｂｖに対する穿刺姿勢は、留置当初の状態が維持される。したがって、医療器具２０Ｂを備える医療デバイス１Ｂは、生体内に留置した後に周囲の生体組織が動いたとしても、血管Ｂｖの穿刺部位に掛かる負荷が抑制されるため、穿刺部位のシール解除による出血のリスクを低減することができる。 In this way, the medical device 20B is configured by the first movable portion 221Ba, the second movable portion 221Bb, and the cover portion 230 that covers the second movable portion 221Bb while holding the first movable portion 221Ba. A portion 22B is provided. As shown in FIG. 7B, the movable part 22B is set to the first movable position even if the placement posture of the components of the medical device 1B (for example, the administration device 10B) changes from the initial placement due to the movement of the living tissue around the medical device 1B. It is possible to absorb changes in posture of the administration device 10B by moving around the portion 221Ba as the center of rotation. Therefore, the indwelling posture of the first portion 211B on the distal side of the third portion 213B of the tube 21B and the puncturing posture of the second portion 212B with respect to the blood vessel Bv are maintained in the initial state of indwelling. Therefore, the medical device 1B including the medical instrument 20B suppresses the load applied to the puncture site of the blood vessel Bv even if the surrounding living tissue moves after being indwelled in the living body. Risk can be reduced.
　また、医療器具２０Ｂは、カバー部２３０を備えるため、前述の出血のリスクの低減効果に加え、第１可動部２２１Ｂａの回転移動により第１可動部２２１Ｂａと第２可動部２２１Ｂｂとの間に生体組織が引き込まれて第１可動部２２１Ｂａの回転が阻害されることを防止する効果も奏することができる。 Further, since the medical device 20B includes the cover portion 230, in addition to the above-described effect of reducing the risk of bleeding, the rotational movement of the first movable portion 221Ba causes the living body to move between the first movable portion 221Ba and the second movable portion 221Bb. It is also possible to achieve the effect of preventing the rotation of the first movable portion 221Ba from being hindered due to the tissue being pulled in.
　［第３形態］
　次に、第３形態に係る医療デバイス１Ｃについて説明する。 [Third form]
Next, a medical device 1C according to the third embodiment will be described.
　第３形態の医療デバイス１Ｃは、第１形態の医療デバイス１Ａの可動部２２Ａや第２形態の医療デバイス１Ｂの可動部２２Ｂとは構造が異なり、チューブ２１Ｃの第３部分２１３Ｃを被覆しつつ、チューブ２１Ｃの第３部分２１３Ｃよりも基端側の第１部分２１１Ｃの姿勢変化に追従して変形しつつ第３部分２１３Ｃを支持する構成を有する。 The medical device 1C of the third embodiment differs in structure from the movable portion 22A of the medical device 1A of the first embodiment and the movable portion 22B of the medical device 1B of the second embodiment. It has the structure which supports the 3rd part 213C, deform|transforming following the attitude|position change of the 1st part 211C of the base end side rather than the 3rd part 213C of the tube 21C.
　医療デバイス１Ｃは、図８、図９Ａ、図９Ｂに示すように、投与装置１０Ｃと、医療器具２０Ｃと、を備える。 The medical device 1C includes an administration device 10C and a medical instrument 20C, as shown in FIGS. 8, 9A, and 9B.
　医療器具２０Ｃの可動部２２Ｃは、チューブ２１Ｃの第３部分２１３Ｃよりも基端側の第１部分２１１Ｃの姿勢変化に追従して変形しつつ第３部分２１３Ｃを支持する支持部２２１Ｃａと、第３部分２１３Ｃよりも基端側の第１部分２１１Ｃの姿勢変化を許容する開口部２２２Ｃを有し、支持部２２１Ｃａで支持された第３部分２１３Ｃを覆う保護部２２１Ｃｂと、を備える。 The movable portion 22C of the medical device 20C includes a support portion 221Ca that supports the third portion 213C while deforming following changes in posture of the first portion 211C on the proximal side of the third portion 213C of the tube 21C, and a third portion 213C. and a protective portion 221Cb that has an opening 222C that allows the position of the first portion 211C on the proximal side of the portion 213C to change, and that covers the third portion 213C supported by the support portion 221Ca.
　支持部２２１Ｃａは、保護部２２１Ｃｂに取り付けられ（図９Ａでは保護部２２１Ｃｂの内周面）、生体組織の動きに伴う第３部分２１３Ｃの姿勢変化に追従して変形しつつ少なくとも第３部分２１３Ｃを支持する。図９Ａに示すように、支持部２２１Ｃａは、一端が第１部分２１１Ｃと第３部分２１３Ｃとの境界部分に接続されているが、少なくとも第３部分２１３Ｃが支持可能な位置であれば、チューブ２１Ｃとの接続位置は特に限定されない。 The support portion 221Ca is attached to the protection portion 221Cb (in FIG. 9A, the inner peripheral surface of the protection portion 221Cb), and deforms in accordance with the change in posture of the third portion 213C due to the movement of the living tissue to support at least the third portion 213C. To support. As shown in FIG. 9A, one end of the supporting portion 221Ca is connected to the boundary between the first portion 211C and the third portion 213C. The connection position with is not particularly limited.
　支持部２２１Ｃａは、第３部分２１３Ｃの姿勢変化に追従しつつ第３部分２１３Ｃが過度に姿勢変化して座屈しないように支持する特性を有する部材で構成するのが好ましい。支持部２２１Ｃａは、一例として弦巻バネなどのバネ部材や、合成ゴム製の弾性体などの弾性部材で構成することができる。 The support part 221Ca is preferably composed of a member having a characteristic of following changes in posture of the third portion 213C and supporting the third portion 213C so that it does not buckle due to excessive posture change. For example, the support portion 221Ca can be configured by a spring member such as a coiled spring or an elastic member such as an elastic body made of synthetic rubber.
　保護部２２１Ｃｂは、一部に開口部２２２Ｃが形成された略中空半球形状をなす。また、保護部２２１Ｃｂは、第３部分２１３Ｃが挿通される挿通孔２２３Ｃが形成される。保護部２２１Ｃｂは、第３部分２１３Ｃを覆った状態で第３部分２１３Ｃの先端側に装着される。 The protective part 221Cb has a substantially hollow hemispherical shape with an opening 222C in part. Further, the protective portion 221Cb is formed with an insertion hole 223C through which the third portion 213C is inserted. The protection portion 221Cb is attached to the tip side of the third portion 213C while covering the third portion 213C.
　図９Ａにおいて、保護部２２１Ｃｂは、第３部分２１３Ｃおよび第３部分２１３Ｃと連続する第１部分２１１Ｃの先端側の一部を覆った構成であるが、少なくとも第３部分２１３Ｃを覆うように構成されればよい。また、保護部２２１Ｃｂの開口部２２２Ｃの開口サイズ（開口径）は、特に制限されず、第１部分２１１Ｃの姿勢変化を阻害しない程度のサイズであればよい。 In FIG. 9A, the protective portion 221Cb is configured to cover the third portion 213C and a portion of the distal end side of the first portion 211C that is continuous with the third portion 213C, and is configured to cover at least the third portion 213C. All you have to do is Also, the opening size (opening diameter) of the opening 222C of the protection portion 221Cb is not particularly limited, and may be any size that does not hinder the posture change of the first portion 211C.
　第３部分２１３Ｃは、先端端が挿通孔２２３Ｃに挿通された状態で保護部２２１Ｃｂに固着され、基端側が支持部２２１Ｃａにより吊られた状態で支持され、その他の部位は固定されないフリーな状態となる。そのため、第３部分２１３Ｃは、例えば第１部分２１１Ｃが姿勢変化した際に支持部２２１Ｄａが所定方向に変形（伸長または収縮）することで、第３部分２１３Ｃよりも基端側の第１部分２１１Ｃの姿勢変化に追従することができる（図９Ｂを参照）。 The third portion 213C is fixed to the protective portion 221Cb with the distal end inserted through the insertion hole 223C, the base end side is supported in a suspended state by the support portion 221Ca, and the other portions are in a free state where they are not fixed. Become. Therefore, the third portion 213C, for example, when the posture of the first portion 211C changes, the support portion 221Da is deformed (extended or contracted) in a predetermined direction, so that the first portion 211C closer to the proximal end than the third portion 213C is. (see FIG. 9B).
　このように、医療器具２０Ｃは、チューブ２１Ｃの第３部分２１３Ｃよりも基端側の第１部分２１１Ｃの姿勢変化に追従して変形しつつ第３部分２１３Ｃを支持する支持部２２１Ｃａと、第３部分２１３Ｃよりも基端側の第１部分２１１Ｃの姿勢変化を許容する開口部２２２Ｃを有し、支持部２２１Ｃａで支持された第３部分２１３Ｃを覆う保護部２２１Ｃｂと、で構成される可動部２２Ｃを備える。可動部２２Ｃは、図９Ｂに示すように、医療デバイス１Ｃの周囲の生体組織の動きにより医療デバイス１Ｃの構成要素（例えば投与装置１０Ｃ）の留置姿勢が留置当初から変化したとしても、支持部２２１Ｃａが適度に変形して第３部分２１３Ｃよりも基端側の第１部分２１１Ｃの姿勢変化に追従することができる。そのため、チューブ２１Ｃの第３部分２１３Ｃよりも先端側の第１部分２１１Ｃの留置姿勢や第２部分２１２Ｃの血管Ｂｖに対する穿刺姿勢は、留置当初の状態が維持される。したがって、医療器具２０Ｃを備える医療デバイス１Ｃは、生体内に留置した後に周囲の生体組織が動いたとしても、血管Ｂｖの穿刺部位に掛かる負荷が抑制されるため、穿刺部位のシール解除による出血のリスクを低減することができる。 In this way, the medical device 20C includes the support portion 221Ca that supports the third portion 213C while deforming in accordance with the posture change of the first portion 211C closer to the proximal end than the third portion 213C of the tube 21C, and the third portion 213C. The movable portion 22C includes a protection portion 221Cb that has an opening 222C that allows the position of the first portion 211C on the proximal side of the portion 213C to change, and that covers the third portion 213C supported by the support portion 221Ca. Prepare. As shown in FIG. 9B, the movable part 22C is configured to support the support part 221Ca even if the placement posture of the components of the medical device 1C (for example, the administration device 10C) changes from the initial placement due to the movement of the living tissue around the medical device 1C. can appropriately deform to follow the posture change of the first portion 211C closer to the proximal side than the third portion 213C. Therefore, the indwelling posture of the first portion 211C on the distal side of the third portion 213C of the tube 21C and the puncturing posture of the second portion 212C with respect to the blood vessel Bv are maintained in the initial state of indwelling. Therefore, the medical device 1C including the medical instrument 20C suppresses the load applied to the puncture site of the blood vessel Bv even if the surrounding living tissue moves after being placed in the living body. Risk can be reduced.
　［第４形態］
　次に、第４形態に係る医療デバイス１Ｄについて説明する。 [Fourth form]
Next, a medical device 1D according to the fourth embodiment will be described.
　第４形態の医療デバイス１Ｄは、第３形態の医療デバイス１Ｃの変形例であり、第３形態の支持部２２１Ｃａの形状および機能を一部変更した構成を有する。 The medical device 1D of the fourth form is a modification of the medical device 1C of the third form, and has a configuration in which the shape and function of the support portion 221Ca of the third form are partially changed.
　医療デバイス１Ｄは、図１０、図１１Ａ、図１１Ｂに示すように、投与装置１０Ｄと、医療器具２０Ｄと、を備える。 The medical device 1D, as shown in FIGS. 10, 11A, and 11B, includes an administration device 10D and a medical instrument 20D.
　医療器具２０Ｄの可動部２２Ｄは、チューブ２１Ｄの第３部分２１３Ｄよりも基端側の第１部分２１１Ｄの姿勢変化に追従して変形しつつ第３部分２１３Ｄを支持する支持部２２１Ｄａと、第３部分２１３Ｄよりも基端側の第１部分２１１Ｄの姿勢変化を許容する開口部２２２Ｄを有し、支持部２２１Ｄａで支持された第３部分２１３Ｄを覆う保護部２２１Ｄｂと、を備える。 The movable portion 22D of the medical device 20D includes a support portion 221Da that supports the third portion 213D while deforming in accordance with the posture change of the first portion 211D closer to the proximal end than the third portion 213D of the tube 21D; and a protective portion 221Db that has an opening 222D that allows the position of the first portion 211D on the proximal side of the portion 213D to change, and that covers the third portion 213D supported by the support portion 221Da.
　支持部２２１Ｄａは、保護部２２１Ｄｂに取り付けられ、生体組織の動きに伴う第３部分２１３Ｄの姿勢変化に追従して変形しつつ少なくとも第３部分２１３Ｄを支持する。図１１Ａに示すように、支持部２２１Ｄａは、保護部２２１Ｄｂに形成された開口部２２２Ｄに取り付けられ、略中央部分には第３部分２１３Ｄが挿通される挿通孔２２４Ｄが形成される。支持部２２１Ｄａは、柔軟性を有する略円形の板材に対し、第３部分２１３Ｄの外周面からチューブ２１Ｄの径方向に沿って蛇腹折りが施された形状（同心円状に山部と谷部が交互に配置された形状）を備え、チューブ２１Ｄの外周面に対してチューブ２１Ｄの径方向に伸縮可能に構成される。支持部２２１Ｄａは、第３部分２１３Ｄの姿勢変化に追従して伸縮可能な柔軟性を有する弾性材料（例えば、合成ゴムや合成樹脂）で構成することができる。なお、支持部２２１Ｄａは、前記蛇腹折りにより伸縮可能な構造を有しているため、必ずしも弾性材料で構成する必要はない。また、図１１Ａに示すように、支持部２２１Ｄａは、第１部分２１１Ｄと第３部分２１３Ｄとの境界部分に接続されているが、少なくとも第３部分２１３Ｄが支持可能な位置であれば、チューブ２１Ｄとの接続位置は特に限定されない。 The support part 221Da is attached to the protection part 221Db, and supports at least the third part 213D while deforming according to the posture change of the third part 213D caused by the movement of the living tissue. As shown in FIG. 11A, the support portion 221Da is attached to an opening 222D formed in the protection portion 221Db, and an insertion hole 224D through which the third portion 213D is inserted is formed in a substantially central portion. The support portion 221Da has a shape in which a flexible, substantially circular plate material is bellows-folded along the radial direction of the tube 21D from the outer peripheral surface of the third portion 213D (concentrically alternating peaks and valleys). ), and is configured to be expandable and contractable in the radial direction of the tube 21D with respect to the outer peripheral surface of the tube 21D. The support portion 221Da can be made of an elastic material (for example, synthetic rubber or synthetic resin) that has flexibility and can expand and contract following changes in the posture of the third portion 213D. Note that the support portion 221Da does not necessarily need to be made of an elastic material because it has a structure that can be expanded and contracted by the accordion folding. Further, as shown in FIG. 11A, the support portion 221Da is connected to the boundary portion between the first portion 211D and the third portion 213D. The connection position with is not particularly limited.
　保護部２２１Ｄｂは、一部に開口部２２２Ｄが形成された略中空半球形状をなす。また、保護部２２１Ｄｂは、第３部分２１３Ｄが挿通される挿通孔２２３Ｄが形成される。保護部２２１Ｄｂは、第３部分２１３Ｄを覆った状態で第３部分２１３Ｄの先端側に装着される。保護部２２１Ｄｂの開口部２２２Ｄの開口サイズ（開口径）は、特に制限されず、第１部分２１１Ｄの姿勢変化を阻害しない程度のサイズであればよい。 The protective part 221Db has a substantially hollow hemispherical shape with an opening 222D in part. Further, the protective portion 221Db is formed with an insertion hole 223D through which the third portion 213D is inserted. The protective portion 221Db is attached to the tip side of the third portion 213D while covering the third portion 213D. The opening size (opening diameter) of the opening 222D of the protection portion 221Db is not particularly limited, and may be any size that does not hinder the posture change of the first portion 211D.
　第３部分２１３Ｄは、先端端が挿通孔２２３Ｄに挿通され、基端側が挿通孔２２４Ｄに挿通された状態で支持部２２１Ｄａに固着され、その他の部位は固定されないフリーな状態となる。そのため、第３部分２１３Ｄは、例えば第１部分２１１Ｄが姿勢変化した際に支持部２２１Ｄａが所定方向に変形（伸長または収縮）することで、第３部分２１３Ｄよりも基端側の第１部分２１１Ｄの姿勢変化に追従することができる（図１１Ｂを参照）。 The third portion 213D is fixed to the support portion 221Da with its distal end inserted through the insertion hole 223D and its base end inserted through the insertion hole 224D, and other portions are left unfixed. Therefore, the third portion 213D is deformed (extended or contracted) in a predetermined direction by the support portion 221Da when the posture of the first portion 211D is changed, for example, so that the first portion 211D on the base end side of the third portion 213D is moved. (See FIG. 11B).
　このように、医療器具２０Ｄは、第３形態と同様、チューブ２１Ｄの第３部分２１３Ｄよりも基端側の第１部分２１１Ｄの姿勢変化に追従して変形しつつ第３部分２１３Ｄを支持する支持部２２１Ｄａと、第３部分２１３Ｄよりも基端側の第１部分２１１Ｄの姿勢変化を許容する開口部２２２Ｄを有し、支持部２２１Ｄａで支持された第３部分２１３Ｄを覆う保護部２２１Ｄｂと、で構成される可動部２２Ｄを備える。可動部２２Ｄは、図１１Ｂに示すように、医療デバイス１Ｄの周囲の生体組織の動きにより医療デバイス１Ｄの構成要素（例えば投与装置１０Ｄ）の留置姿勢が留置当初から変化したとしても、支持部２２１Ｄａが適度に変形して第３部分２１３Ｄよりも基端側の第１部分２１１Ｄの姿勢変化に追従することができる。そのため、チューブ２１Ｄの第３部分２１３Ｄよりも先端側の第１部分２１１Ｄの留置姿勢や第２部分２１２Ｄの血管Ｂｖに対する穿刺姿勢は、留置当初の状態が維持される。したがって、医療器具２０Ｄを備える医療デバイス１Ｄは、生体内に留置した後に周囲の生体組織が動いたとしても、血管Ｂｖの穿刺部位に掛かる負荷が抑制されるため、穿刺部位のシール解除による出血のリスクを低減することができる。 Thus, the medical device 20D supports the third portion 213D of the tube 21D while deforming in accordance with the posture change of the first portion 211D closer to the proximal end than the third portion 213D of the tube 21D, as in the third embodiment. a portion 221Da, and a protection portion 221Db that has an opening 222D that allows a change in posture of the first portion 211D on the proximal side of the third portion 213D and that covers the third portion 213D supported by the support portion 221Da. A movable part 22D is provided. As shown in FIG. 11B , the movable part 22D is configured to support the supporting part 221Da even if the placement posture of the components of the medical device 1D (for example, the administration device 10D) changes from the initial placement due to the movement of the living tissue around the medical device 1D. can appropriately deform to follow the posture change of the first portion 211D closer to the proximal side than the third portion 213D. Therefore, the indwelling posture of the first portion 211D on the distal side of the third portion 213D of the tube 21D and the puncturing posture of the second portion 212D with respect to the blood vessel Bv are maintained in the initial state of indwelling. Therefore, the medical device 1D including the medical instrument 20D suppresses the load applied to the puncture site of the blood vessel Bv even if the surrounding living tissue moves after being indwelled in the body. Risk can be reduced.
　［作用効果］
　以上説明したように、本実施形態に係る医療器具２０は、生体内において周囲の生体組織に動きが生じる位置に留置される投与装置１０に装着され、投与装置１０から放出される被投与物Ｘを送達部位に送達するものであって、前記投与装置に接続され前記投与装置から血管を通じて前記送達部位まで延在し、穿刺部位となる血管Ｂｖの血管壁Ｂｗより投与装置１０側に位置する第１部分２１１と、血管壁Ｂｗより送達部位側に位置する第２部分２１２と、を有するチューブ２１と、第１部分２１１に装着され、第１部分２１１の一部を保持した状態で生体組織の動きに追従して可動する可動部２２と、を備える。 [Effect]
As described above, the medical device 20 according to the present embodiment is attached to the administration device 10 that is indwelled at a position in the living body where movement occurs in the surrounding living tissue, and the administration device 10 ejects the object X to be administered. is connected to the administration device and extends from the administration device through the blood vessel to the delivery site, and is located closer to the administration device 10 side than the blood vessel wall Bw of the blood vessel Bv serving as the puncture site A tube 21 having a first portion 211 and a second portion 212 located closer to the delivery site side than the blood vessel wall Bw, and attached to the first portion 211 to hold a portion of the first portion 211 while the body tissue is being cut. and a movable part 22 that moves following the movement.
　このような構成により、可動部２２は、生体組織の動きによる投与装置１０やチューブ２１の姿勢変化に追従しながら、少なくともチューブ２１の第１部分２１１の一部を保持した状態で可動することができるため、チューブ２１の第２部分２１２の血管Ｂｖに対する穿刺姿勢を維持することができる。したがって、医療器具２０は、留置先の生体組織の動きにより投与装置１０やチューブ２１の姿勢が変化したとしても、これら姿勢変化を吸収して血管Ｂｖの穿刺部位に掛かる負荷を抑制し、穿刺部位のシール解除による出血のリスクを低減することができる。 With such a configuration, the movable part 22 can move while holding at least a part of the first portion 211 of the tube 21 while following changes in posture of the administration device 10 and the tube 21 due to movement of living tissue. Therefore, the posture of the second portion 212 of the tube 21 to puncture the blood vessel Bv can be maintained. Therefore, even if the postures of the administration device 10 and the tube 21 change due to the movement of the living tissue at the indwelling destination, the medical device 20 absorbs these posture changes and suppresses the load applied to the puncture site of the blood vessel Bv. can reduce the risk of bleeding due to unsealing.
　また、本実施形態に係る医療器具２０において、可動部２２は、第１部分２１１における可動部２２の装着部分に相当する第３部分２１３を覆って保持した状態で第１部分２１１に装着され、生体組織の動きによる第３部分２１３および第３部分２１３よりも基端側の第１部分２１１の姿勢変化に追従して可動する構成としてもよい。 Further, in the medical device 20 according to the present embodiment, the movable part 22 is mounted on the first part 211 while covering and holding the third part 213 corresponding to the mounting part of the movable part 22 in the first part 211, It is also possible to adopt a configuration in which the third portion 213 and the first portion 211 closer to the proximal end than the third portion 213 are moved following the change in posture caused by the movement of living tissue.
　このような構成により、チューブ２１の可動部２２の装着部分となる第３部分２１３が可動部２２により覆われた状態となるため、周囲の生体組織による第３部分２１３の潰れなどが防止され、チューブ２１の連通状態が維持される。 With this configuration, the third portion 213 of the tube 21 to which the movable portion 22 is attached is covered with the movable portion 22, so that the third portion 213 is prevented from being crushed by the surrounding living tissue. The communication state of the tube 21 is maintained.
　また、本実施形態に係る医療器具２０Ａにおいて、可動部２２Ａは、第３部分２１３Ａの基端側に第３部分２１３Ａの一部を覆うように装着され、第３部分２１３Ａよりも基端側の第１部分２１１Ａの姿勢変化に伴う回転中心となる第１可動部２２１Ａａと、第３部分２１３Ａの先端側に装着され、第１可動部２２１Ａａの一部を覆いながら第１可動部２２１Ａａを回転可能に保持する第２可動部２２１Ａｂと、を備える構成としてもよい。 In the medical device 20A according to the present embodiment, the movable portion 22A is mounted on the proximal side of the third portion 213A so as to cover a part of the third portion 213A, and is located on the proximal side of the third portion 213A. The first movable part 221Aa, which serves as the center of rotation when the posture of the first part 211A changes, is attached to the distal end side of the third part 213A, and the first movable part 221Aa can be rotated while covering a part of the first movable part 221Aa. It is good also as a structure provided with 2nd movable part 221Ab hold|maintained at.
　このような構成により、医療器具２０Ａは、医療デバイス１Ａの周囲の生体組織の動きにより例えば投与装置１０Ａの留置姿勢が留置当初から変化したとしても、第１可動部２２１Ａａを回転中心として投与装置１０Ａの姿勢変化を吸収することができる。これにより、チューブ２１Ａの第３部分２１３Ａよりも先端側の第１部分２１１Ａの留置姿勢や第２部分２１２Ａの血管Ｂｖに対する穿刺姿勢は、留置当初の状態が維持される。したがって、医療器具２０Ａは、血管Ｂｖの穿刺部位に掛かる負荷が抑制され、穿刺部位のシール解除による出血のリスクを低減することができる。 With such a configuration, the medical device 20A can rotate around the first movable portion 221Aa even if the placement posture of the administration device 10A changes from the initial placement due to the movement of the living tissue around the medical device 1A. posture change can be absorbed. As a result, the indwelling posture of the first portion 211A on the distal side of the third portion 213A of the tube 21A and the puncturing posture of the second portion 212A with respect to the blood vessel Bv are maintained in the initial state of indwelling. Therefore, the medical device 20A can suppress the load applied to the puncture site of the blood vessel Bv, and reduce the risk of bleeding due to releasing the seal of the puncture site.
　また、本実施形態に係る医療器具２０Ｂにおいて、可動部２２Ｂは、第３部分２１３Ｂよりも基端側の第１部分２１１Ｂの姿勢変化を許容する開口部２３１を有し、第１可動部２２１Ｂａを保持した第２可動部２２１Ｂｂを覆うカバー部２３０をさらに備える構成としてもよい。 In the medical device 20B according to this embodiment, the movable portion 22B has an opening 231 that allows the first portion 211B on the proximal side of the third portion 213B to change its posture, and the first movable portion 221Ba. A configuration may be adopted in which a cover portion 230 that covers the held second movable portion 221Bb is further provided.
　このような構成により、医療器具２０Ｂは、カバー部２３０を備えるため、医療デバイス１Ｂの構成要素（例えば投与装置１０Ｂ）の留置姿勢の変化を起因とする出血のリスクの低減効果に加え、第１可動部２２１Ｂａの回転移動により第１可動部２２１Ｂａと第２可動部２２１Ｂｂとの間に生体組織が引き込まれて第１可動部２２１Ｂａの回転が阻害されることも防止することができる。 With such a configuration, the medical device 20B includes the cover portion 230. Therefore, in addition to the effect of reducing the risk of bleeding caused by changes in the indwelling posture of the components of the medical device 1B (for example, the administration device 10B), the first It is also possible to prevent the rotation of the first movable portion 221Ba from being hindered due to the living tissue being drawn between the first movable portion 221Ba and the second movable portion 221Bb due to the rotational movement of the movable portion 221Ba.
　また、本実施形態に係る医療器具２０Ｃ、２０Ｄにおいて、可動部２２Ｃ、２２Ｄは、第３部分２１３Ｃ、２１３Ｄよりも基端側の第１部分２１１Ｃ、２１１Ｄの姿勢変化に追従して変形しつつ第３部分２１３Ｃ、２１３Ｄを支持する支持部２２１Ｃａ、２２１Ｄａと、第３部分２１３Ｃ、２１３Ｄよりも基端側の第１部分２１１Ｃ、２１１Ｄの姿勢変化を許容する開口部２２２Ｃ、２２２Ｄを有し、支持部２２１Ｃａ、２２１Ｄａで支持された第３部分２１３Ｃ、２１３Ｄを覆う保護部２２１Ｃｂ、２２１Ｄｂと、を備える構成としてもよい。 In addition, in the medical instruments 20C and 20D according to the present embodiment, the movable portions 22C and 22D are deformed while following the posture change of the first portions 211C and 211D closer to the proximal side than the third portions 213C and 213D. It has support portions 221Ca and 221Da that support the three portions 213C and 213D, and opening portions 222C and 222D that allow posture changes of the first portions 211C and 211D closer to the proximal side than the third portions 213C and 213D. A configuration including protection portions 221Cb and 221Db covering the third portions 213C and 213D supported by 221Ca and 221Da may be provided.
　このような構成により、医療器具２０Ｃ、２０Ｄは、医療デバイス１Ｃ、１Ｄの周囲の生体組織の動きにより医療デバイス１Ｃ、１Ｄの構成要素（例えば投与装置１０Ｃ、１０Ｄ）の留置姿勢が留置当初から変化したとしても、支持部２２１Ｃａ、２２１Ｄａが適度に変形しながらチューブ２１Ｃ、２１Ｄに追従して投与装置１０Ｃ、１０Ｄの姿勢変化を吸収することができる。これにより、チューブ２１Ｃ、２１Ｄの第３部分２１３Ｃ、２１３Ｄよりも先端側の第１部分２１１Ｃ、２１１Ｄの留置姿勢や第２部分２１２Ｃ、２１２Ｄの血管Ｂｖに対する穿刺姿勢は、留置当初の状態が維持される。したがって、医療器具２０Ｃ、２０Ｄは、血管Ｂｖの穿刺部位に掛かる負荷が抑制され、穿刺部位のシール解除による出血のリスクを低減することができる。 With such a configuration, in the medical devices 20C and 20D, the components of the medical devices 1C and 1D (for example, the administration devices 10C and 10D) change their placement postures from the beginning of placement due to the movement of the living tissue around the medical devices 1C and 1D. Even so, the support portions 221Ca and 221Da can follow the tubes 21C and 21D while deforming appropriately to absorb the posture change of the administration devices 10C and 10D. As a result, the indwelling posture of the first portions 211C and 211D on the distal side of the third portions 213C and 213D of the tubes 21C and 21D and the puncturing posture of the second portions 212C and 212D with respect to the blood vessel Bv are maintained in the initial state of indwelling. be. Therefore, the medical instruments 20C and 20D can suppress the load applied to the puncture site of the blood vessel Bv, and reduce the risk of bleeding due to releasing the seal at the puncture site.
　また、本実施形態に係る医療デバイス１は、上記何れかに記載の医療器具２０（２０Ａ～２０Ｄ）と、先端側に医療器具２０（２０Ａ～２０Ｄ）が装着され、生体内において周囲の生体組織に動きが生じる位置に留置される投与装置１０（１０Ａ～１０Ｄ）と、を備え、投与装置１０（１０Ａ～１０Ｄ）から放出された被投与物Ｘを、医療器具２０（２０Ａ～２０Ｄ）を介して送達部位に送達する。 Further, the medical device 1 according to the present embodiment is equipped with any of the medical instruments 20 (20A to 20D) described above and the medical instrument 20 (20A to 20D) on the distal end side, and is equipped with the surrounding biological tissue in vivo. and an administration device 10 (10A to 10D) indwelled at a position where movement occurs, and the administration subject X released from the administration device 10 (10A to 10D) is passed through the medical device 20 (20A to 20D). delivered to the delivery site.
　医療デバイス１は、生体内に留置されると、投与装置１０やチューブ２１が周囲の生体組織の動きより留置当初の留置姿勢から変化することがある。この際、特にチューブ２１の第２部分２１２の姿勢が変化すると、穿刺部位となる血管Ｂｖの血管壁Ｂｗに負荷が掛かり、シールが解除されて出血する虞がある。可動部２２は、生体組織の動きによる投与装置１０やチューブ２１の姿勢変化に追従しながら、少なくともチューブ２１の第１部分２１１の一部を保持した状態で可動することができるため、チューブ２１の第２部分２１２の血管Ｂｖに対する穿刺姿勢を維持することができる。したがって、医療器具２０を備える医療デバイス１は、留置先の生体組織の動きにより投与装置１０やチューブ２１の姿勢が変化したとしても、これら姿勢変化を吸収して血管Ｂｖの穿刺部位に掛かる負荷を抑制し、穿刺部位のシール解除による出血のリスクを低減することができる。 When the medical device 1 is left in the living body, the administration device 10 and the tube 21 may change from the initial placement posture due to the movement of the surrounding living tissue. At this time, especially when the posture of the second portion 212 of the tube 21 changes, a load is applied to the blood vessel wall Bw of the blood vessel Bv, which is the puncture site, and there is a risk that the seal will be released and bleeding will occur. The movable part 22 can move while holding at least a part of the first portion 211 of the tube 21 while following changes in posture of the administration device 10 and the tube 21 due to movement of living tissue. The puncturing posture of the second portion 212 with respect to the blood vessel Bv can be maintained. Therefore, even if the posture of the administration device 10 or the tube 21 changes due to the movement of the living tissue at the indwelling destination, the medical device 1 including the medical device 20 absorbs the change in posture and reduces the load applied to the puncture site of the blood vessel Bv. and reduce the risk of bleeding due to unsealing of the puncture site.
　本出願は、２０２１年１１月３０日に出願された日本国特許出願第２０２１－１９３９５５号に基づいており、その開示内容は、参照により全体として引用されている。 This application is based on Japanese Patent Application No. 2021-193955 filed on November 30, 2021, the disclosure of which is incorporated by reference in its entirety.
　１（１Ａ～１Ｄ）　医療デバイス、
　１０（１０Ａ～１０Ｄ）　投与装置、
　２０（２０Ａ～２０Ｄ）　医療器具、
　２１（２１Ａ～２１Ｄ）　チューブ、
　２１１（２１１Ａ～２１１Ｄ）　チューブの第１部分、
　２１２（２１２Ａ～２１２Ｄ）　チューブの第２部分、
　２１３（２１３Ａ～２１３Ｄ）　チューブの第３部分、
　２２（２２Ａ～２２Ｄ）　可動部、
　２２１Ａａ、２２１Ｂａ　第１可動部、
　２２１Ａｂ、２２１Ｂｂ　第２可動部、
　２２１Ｃａ、２２１Ｄａ　支持部、
　２２１Ｃｂ、２２１Ｄｂ　保護部、
　２２２Ａａ、２２２Ａｂ、２２２Ｂａ、２２２Ｂｂ、２２２Ｃ、２２２Ｄ　開口部、
　２３０　カバー部（２３１　開口部）、
　Ｂｖ　血管、
　Ｂｗ　血管壁、
　Ｓ　皮下組織、
　Ｘ　被投与物。 1 (1A-1D) medical devices,
10 (10A-10D) administration device,
20 (20A-20D) medical instruments,
21 (21A-21D) tubes,
211 (211A-211D) the first portion of the tube;
212 (212A-212D) the second portion of the tube;
213 (213A-213D) the third portion of the tube;
22 (22A to 22D) movable part,
221Aa, 221Ba first movable portion,
221Ab, 221Bb second movable portion,
221Ca, 221Da support,
221Cb, 221Db protection part,
222Aa, 222Ab, 222Ba, 222Bb, 222C, 222D openings,
230 cover portion (231 opening),
Bv blood vessels,
Bw vessel wall,
S subcutaneous tissue,
X recipient.

Claims (6)

  1. 　生体内において周囲の生体組織に動きが生じる位置に留置される投与装置に装着され、前記投与装置から放出される被投与物を送達部位に送達する医療器具であって、
    　前記投与装置に接続され前記投与装置から血管を通じて前記送達部位まで延在し、穿刺部位となる前記血管の血管壁より前記投与装置側に位置する第１部分と、前記血管壁より前記送達部位側に位置する第２部分と、を有するチューブと、
    　前記第１部分に装着され、前記第１部分の一部を保持した状態で前記生体組織の動きに追従して可動する可動部と、
    　を備える、医療器具。     A medical device that is attached to an administration device that is indwelled in a position where movement occurs in surrounding biological tissues in vivo, and that delivers a substance to be administered released from the administration device to a delivery site,
    a first portion connected to the administration device and extending from the administration device through the blood vessel to the delivery site and positioned closer to the delivery site than the blood vessel wall of the blood vessel serving as a puncture site; a tube having a second portion located at
    a movable part that is attached to the first part and moves following the movement of the living tissue while holding a part of the first part;
    A medical device comprising:
  2. 　前記可動部は、前記第１部分における前記可動部の装着部分に相当する第３部分を覆って保持した状態で前記第１部分に装着され、前記生体組織の動きによる前記第３部分および前記第３部分よりも基端側の前記第１部分の姿勢変化に追従して可動する、請求項１に記載の医療器具。 The movable part is attached to the first part in a state of covering and holding a third part corresponding to the attachment part of the movable part in the first part. 2. The medical device according to claim 1, wherein the first portion, which is closer to the proximal end than the three portions, is movable following a change in posture.
  3. 　前記可動部は、
    　前記第３部分の基端側に前記第３部分の一部を覆うように装着され、前記第３部分よりも基端側の前記第１部分の姿勢変化に伴う回転中心となる第１可動部と、
    　前記第３部分の先端側に装着され、前記第１可動部の一部を覆いながら前記第１可動部を回転可能に保持する第２可動部と、
    　を備える、請求項２に記載の医療器具。     The movable part is
    A first movable part mounted on the base end side of the third part so as to cover a part of the third part, and serving as a rotation center according to a change in posture of the first part on the base end side of the third part. and,
    a second movable part mounted on the distal end side of the third part and rotatably holding the first movable part while covering a part of the first movable part;
    3. The medical device of claim 2, comprising:
  4. 　前記可動部は、前記第３部分よりも基端側の前記第１部分の姿勢変化を許容する開口部を有し、前記第１可動部を保持した前記第２可動部を覆うカバー部をさらに備える、請求項３に記載の医療器具。 The movable section further includes a cover section that has an opening that allows a change in posture of the first section that is closer to the base end than the third section, and that covers the second movable section that holds the first movable section. 4. The medical device of claim 3, comprising:
  5. 　前記可動部は、
    　前記第３部分よりも基端側の前記第１部分の姿勢変化に追従して変形しつつ前記第３部分を支持する支持部と、
    　前記第３部分よりも基端側の前記第１部分の姿勢変化を許容する開口部を有し、前記支持部で支持された前記第３部分を覆う保護部と、
    　を備える、請求項２に記載の医療器具。     The movable part is
    a support portion that supports the third portion while deforming following changes in posture of the first portion that is closer to the proximal end than the third portion;
    a protection part that has an opening that allows a posture change of the first part on the base end side of the third part and that covers the third part supported by the support part;
    3. The medical device of claim 2, comprising:
  6. 　請求項１～５の何れか１項に記載の医療器具と、
    　先端側に前記医療器具が装着され、生体内において周囲の前記生体組織に動きが生じる位置に留置される投与装置と、を備え、
    　前記投与装置から放出された前記被投与物を、前記医療器具を介して送達部位に送達する、医療デバイス。
          a medical device according to any one of claims 1 to 5;
    an administration device to which the medical device is mounted on the distal end side and left in a position where movement occurs in the surrounding biological tissue in the living body;
    A medical device that delivers the administered substance released from the administration device to a delivery site via the medical device.
PCT/JP2022/040618 2021-11-30 2022-10-31 Medical instrument and medical device WO2023100571A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2021-193955 2021-11-30
JP2021193955 2021-11-30

Publications (1)

Publication Number Publication Date
WO2023100571A1 true WO2023100571A1 (en) 2023-06-08

Family

ID=86611932

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2022/040618 WO2023100571A1 (en) 2021-11-30 2022-10-31 Medical instrument and medical device

Country Status (1)

Country Link
WO (1) WO2023100571A1 (en)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008508024A (en) * 2004-07-28 2008-03-21 アーディアン インコーポレイテッド Renal nerve blocking method and apparatus
JP2011505988A (en) * 2007-12-11 2011-03-03 マサチューセッツ インスチテュート オブ テクノロジー Implantable drug delivery device and method for treating bladder and other body vesicles or lumens
JP2020023562A (en) * 2009-09-28 2020-02-13 インターシア セラピューティクス，インコーポレイティド Rapid establishment and/or termination of substantial steady-state drug delivery

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008508024A (en) * 2004-07-28 2008-03-21 アーディアン インコーポレイテッド Renal nerve blocking method and apparatus
JP2011505988A (en) * 2007-12-11 2011-03-03 マサチューセッツ インスチテュート オブ テクノロジー Implantable drug delivery device and method for treating bladder and other body vesicles or lumens
JP2020023562A (en) * 2009-09-28 2020-02-13 インターシア セラピューティクス，インコーポレイティド Rapid establishment and/or termination of substantial steady-state drug delivery

Similar Documents

Publication Publication Date Title
EP2968762B1 (en) Multi-chamber injection device
US9017289B2 (en) Transdermal fluid delivery device
US9005163B2 (en) Balloon catheter with external delivery tube
US11344708B2 (en) Microneedle system for administering liquid formulations
US20070016149A1 (en) Injection Needle
JP4954084B2 (en) Device for injecting drug active factors
JPS6077766A (en) Insuline administration apparatus into abdominal cavity
JP2001510080A (en) Catheter assembly for percutaneous access to a subcutaneous port
JP2008528086A (en) Medical device with protected puncture device
EP1624916A1 (en) External inserter for transcutaneous device
US10518071B2 (en) Transdermal microneedle drug delivery device and method
US7758549B2 (en) Injection needle assembly comprising an injection needle and a needle guide
US7731705B2 (en) Eluting coils and methods of deploying and retrieving
JP2021532871A (en) Needle insertion and retreat mechanism
JPH0663145A (en) Balloon catheter for intravascular dosing
WO2023100571A1 (en) Medical instrument and medical device
US20140005595A1 (en) Delivery devices and methods for delivering therapeutic agents
US20220143302A1 (en) Torsional insertion devices
CN116829223A (en) Medical device with fluid-actuated actuation mechanism
CN116829114A (en) Medical device with improved actuation mechanism
WO2023080251A1 (en) Medical instrument
JP6765990B2 (en) Medical device
JP2022513945A (en) Device for delivery of therapeutic fluids
WO2023181997A1 (en) Continuous administering device
WO2023085144A1 (en) Administration device

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 22901004

Country of ref document: EP

Kind code of ref document: A1