WO2020095496A1 - Method for reducing pain, liquid and medical instrument - Google Patents

Method for reducing pain, liquid and medical instrument Download PDF

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Publication number
WO2020095496A1
WO2020095496A1 PCT/JP2019/030565 JP2019030565W WO2020095496A1 WO 2020095496 A1 WO2020095496 A1 WO 2020095496A1 JP 2019030565 W JP2019030565 W JP 2019030565W WO 2020095496 A1 WO2020095496 A1 WO 2020095496A1
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Prior art keywords
liquid
pain
puncture
inner cavity
distilled water
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PCT/JP2019/030565
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French (fr)
Japanese (ja)
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涼 経田
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テルモ株式会社
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P23/00—Anaesthetics
    • A61P23/02—Local anaesthetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

  • the present invention relates to a method for reducing pain, a liquid and a medical device.
  • Patent Document 1 discloses a technique of administering a composition containing bicarbonate, nitrate, phosphate or the like when performing epidural anesthesia.
  • the merit of the method using epidural anesthesia as in Patent Document 1 is that the pain relief effect is high, the consciousness of the mother is clear, the anesthetic does not affect the fetus, and caesarean section can be performed as it is. ..
  • the demerit of epidural anesthesia may be serious complications such as anesthesia poisoning. Therefore, a medical institution that performs epidural anesthesia needs to have a doctor such as an experienced anesthesiologist and a facility system that can respond in an emergency.
  • the number of anesthesiologists in Japan is insufficient, and an experienced anesthesiologist cannot always handle all pregnant women.
  • an object of the present invention is to provide a pain reducing method that can reduce the pain in the lower back during delivery without resorting to epidural anesthesia.
  • a method for reducing pain according to the present invention comprising a lumen and a puncture portion, and using the puncture portion of a medical device in which the lumen is pre-filled with a liquid, skin on the lumbar region of a pregnant woman during delivery Form a puncture site inside. Then, by injecting the liquid from the lumen into the puncture site, stimulation is given to a nerve having a faster conduction velocity than the nerve stimulated by uterine contraction. Further, the present invention is a liquid used in the above-mentioned method for reducing pain. The present invention is also a medical device in which the above-mentioned lumen is pre-filled with a liquid.
  • the liquid and the medical device used in the pain reducing method according to the present invention by injecting the liquid into the skin in the lumbar region of a pregnant woman from the lumen of the medical device, without depending on epidural anesthesia.
  • the pain in the lower back of a pregnant woman during delivery can be reduced.
  • FIG. 2 is a diagram in the vicinity of a waist showing a puncture site of a human body punctured by the medical device shown in FIG. 1.
  • 3 is a flowchart showing a pain reducing method according to an embodiment of the present invention. It is a fragmentary sectional view which shows the modification of the syringe main body in FIG.
  • FIG. 1 is an exploded front view showing a medical device 100 used in a pain reducing method according to an embodiment of the present invention.
  • FIG. 2 is an enlarged view showing the tip of the puncture part of the medical device 100 shown in FIG.
  • FIG. 3 is a partial cross-sectional view of the medical device 100 shown in FIG.
  • the pain reducing method according to the present embodiment is used to reduce back pain and the like of a pregnant woman who gives birth by natural delivery or the like.
  • the medical device 100 used in the pain reducing method according to the present embodiment will be described.
  • the medical device 100 includes a syringe body 10 and a needle assembly 20 as shown in FIG.
  • the syringe main body 10 includes a pusher 11, an outer cylinder 12, a lock mechanism 16, a cylinder tip 17, and a cap 18.
  • the pusher 11 is configured to push the liquid filled in the inner cavity 14 toward an injection needle 27 described below.
  • the inner cavity 14 is configured to be provided inside the outer cylinder 12.
  • the pusher 11 is configured to be insertable into the inner cavity 14 of the outer cylinder 12.
  • a gasket 13 made of rubber or the like is attached to the tip of the pusher 11, and the pusher 11 can be inserted into the inner cavity 14 of the outer cylinder 12 together with the gasket 13.
  • the base end of the pusher 11 is configured to be exposed from the outer cylinder 12 as shown in FIG.
  • sterilized distilled water 15 is preliminarily liquid-tightly sealed before use.
  • the sterilized distilled water 15 corresponds herein to a liquid that is injected (administered) intradermally in the lumbar region of a pregnant woman.
  • the term “liquid” means a liquid that can be administered to a pregnant woman at birth without having to be an anesthesiologist, such as epidural anesthesia.
  • the distilled water 15 sterilized in the present embodiment is not particularly limited as long as distilled water is subjected to a sterilization treatment.
  • distilled water 15 produced by a reverse osmosis method and a distillation method distilled water subjected to high pressure steam sterilization, etc.
  • the barrel tip 17 extends from the outer barrel 12, and as shown in FIG. 3, the barrel tip 17 is provided therein with an inner cavity 14 having a diameter smaller than that of the proximal end side.
  • the lock mechanism 16 is formed of a female screw that can be screwed into the cap 18 in this embodiment.
  • a male screw is provided on the cap 18, and the distilled water 15 contained in the inner cavity 14 is sealed by screwing the male screw of the cap 18 and the female screw of the lock mechanism 16 together.
  • the injection needle assembly 20 includes an engagement tube 22, an elastic body 23, a needle hub 24, a stabilizing portion 26, and an injection needle 27 (corresponding to a puncturing portion).
  • the engagement cylinder 22 is provided with a male screw which can be screwed with a female screw of the lock mechanism 16 on the outer peripheral surface.
  • the needle hub 24 is configured to hold the injection needle 27 at the tip of the injection needle assembly 20.
  • the elastic body 23 is configured to fill a gap provided between the barrel tip 17 and the needle hub 24 by the engagement of the lock mechanism 16 and the engagement barrel 22.
  • the injection needle 27 is provided with a needle hole communicating from the needle tip to the needle base end, and a needle tube having a blade surface is provided at the needle tip.
  • the injection needle 27 is configured to project from the adjusting portion 25 of the needle hub 24.
  • the stabilizing portion 26 is formed in a hollow cylindrical shape at the needle tip of the needle hub 24, and is configured to surround the adjusting portion 25 from the outside in the radial direction.
  • the length L1 from the needle tip of the injection needle 27 to the needle tip side end surface of the adjusting portion 25 is about 2 mm at the longest, and the needle barrel length L2 is about 1 mm at the shortest, which is 26 to 25 gauge. (Corresponding to a diameter of 0.45 to 0.15 mm).
  • the injection needle assembly 20 is surrounded by a packaging container 21b and a packaging lid 21a which are integrally configured until just before use, and can be taken out by separating the packaging lid 21a from the packaging container 21b and separating the packaging lid 21a. I am configuring.
  • the material of the member forming the medical device 100 is not particularly limited, but the following is an example.
  • the outer cylinder 12, the lock mechanism 16, the cylinder tip 17, the engagement cylinder 22, the needle hub 24, the adjusting portion 25, and the stabilizing portion 26 can be made of polypropylene, polyethylene, cycloolefin polymer, or the like.
  • the gasket 13 and the elastic body 23 can be made of various rubber materials such as natural rubber and silicone rubber, various thermoplastic elastomers such as polyurethane series and styrene series, or a mixture thereof.
  • the injection needle 27 can be made of stainless steel, aluminum, aluminum alloy, titanium, titanium alloy or other metal.
  • FIG. 4 is a (back) view in the vicinity of the waist showing a puncture site of a human body to be punctured by the medical device 100 shown in FIG.
  • FIG. 5 is a flowchart showing a pain reducing method according to an embodiment of the present invention.
  • the medical device 100 in which the lumen 14 is pre-filled with 0.1 ml of sterilized distilled water 15.
  • the pregnant woman lays down on a known delivery table (not shown) in a supine posture in response to instructions from a doctor or midwife (ST1). Then, the posture is temporarily changed so that the vicinity of the waist, which is the puncture points P1 to P4, faces the doctor even in the back.
  • the doctor peels and separates the packaging lid 21a from the packaging container 21b, and takes out the injection needle assembly 20 from the packaging container 21b.
  • the cap 18 of the syringe main body 10 is removed from the barrel tip 17, and the male screw of the engagement barrel 22 of the injection needle assembly 20 and the female screw of the lock mechanism 16 are screwed onto the barrel tip 17.
  • the injection needle assembly 20 is attached to the syringe body 10.
  • the gap between the cylinder tip 17 and the needle hub 24 is filled without any gap by the elastic deformation of the elastic body 23, resulting in a liquid-tight state.
  • the doctor directs the needle tip of the injection needle 27 of the injection needle assembly 20 to the puncture points P1 to P4 near the waist, which is the puncture site, as shown in FIG.
  • the doctor has about 0.1 ml of distilled water 15 sterilized by using the medical device 100 in a state facing the vicinity of the lumbar region of the pregnant woman, and two places on the left and right except on the spinal column of the pregnant woman, for a total of four places (the puncture in FIG. 4). It is intradermally administered (injected) at points P1 to P4) (ST2).
  • the doctor or the like presses the medical device 100 so that the injection needle 27 is perpendicular to the skin 30.
  • the needle tip of the injection needle 27 is punctured into the skin 30.
  • the stabilizing unit 26 presses the skin epidermis 33 of the skin 30, and the adjusting unit 25 contacts the skin epidermis 33.
  • the surface of the skin epidermis 33 is pulled by the adjusting unit 25 and the stabilizing unit 26, and the medical treatment is performed by the needle hub 24.
  • the device 100 is fixed (stabilized) to the puncture site.
  • the injection needle 27 penetrates the skin epidermis 33 by the sharp blade surface of the needle tip, and the opening of the needle hole of the blade surface is 1 to 4 mm from the surface of the skin epidermis 33, just inside the skin 32 of the upper skin layer.
  • the target position is a shallow intradermal target site, but not the subcutaneous tissue 31.
  • the pusher 11 is pushed down to inject sterilized distilled water 15.
  • the sterilized distilled water 15 reaches the inside of the skin 32 having a depth of 1 to 4 mm from the surface of the skin epidermis 33.
  • the pregnant woman After administration of distilled water 15, the pregnant woman should be in the supine position on the delivery table, and the left and right thighs and lower legs should be opened apart and placed on the foot rest of the delivery table. Then, according to the instruction of the doctor or midwife, the fetus is delivered from the uterine ostium while changing the body position such as raising the upper body, breathing, or taking a deep breath (ST3).
  • ST3 deep breath
  • the pain reduction method according to the present embodiment can be expected to have a significant pain relief effect as compared with no treatment or massage.
  • the duration of pain relief is about 2 hours at maximum, and repeated administration of distilled water 15 is also possible.
  • the pain reduction method based on this method is considered to be based on the so-called gate control theory. That is, the uterine contraction in labor during labor is visceral pain sensation and is mediated by C nerve fiber.
  • the C nerve fiber is a relatively thin unmyelinated nerve and has a slow conduction velocity.
  • the visceral pain sensation is suppressed by stimulating the A ⁇ nerve fibers (tactile / pressure sensation) and A ⁇ nerve fibers (somatic pain sensation), which are thicker and faster in conduction velocity (myelinated nerves). This alleviates the pain caused by uterine contraction, which is a visceral pain sensation.
  • the pain reduction method of the present invention the consciousness of a pregnant woman is not affected and the behavior is not restricted. Therefore, it is possible to prevent the progress of labor after the injection of the distilled water 15 from being affected. Further, in this method, sterilized distilled water 15 is applied intradermally to the above-mentioned location, and manual labor is required only during administration. Furthermore, it is possible to perform treatment without requiring a doctor having specialized knowledge such as epidural anesthesia.
  • this method is safe for mothers and children, and at least has no side effects on children.
  • the method does not require anesthesia such as epidural anesthesia and can reduce the cost of the procedure.
  • the pain reducing method according to the present embodiment can be used in combination with other pain reducing methods such as Lammers method, massage, and aromatherapy.
  • the pain reducing method according to the present embodiment includes the lumen 14 and the injection needle 27, and the delivery is performed using the injection needle 27 of the medical device 100 in which the lumen 14 is preliminarily filled with distilled water 15. Puncture points P1 to P4 are formed on the waist of the pregnant woman. Then, sterilized distilled water 15 is injected (administered) from the inner cavity 14 of the medical device 100 into the skin at the puncture points P1 to P4. As a result, stimulation is imparted to nerves having a faster conduction velocity than nerves stimulated by uterine contractions.
  • epidural anesthesia is another method for reducing the pain caused by uterine contractions in pregnant women at birth. It is said that epidural anesthesia is highly effective in reducing pain, the maternal consciousness is clear, the anesthesia does not affect the fetus, and caesarean section can be performed as it is. However, epidural anesthesia becomes difficult to move, and in some cases, fever and hypotension may occur, which may cause serious complications such as anesthetic poisoning and, in the worst case, death.
  • the puncture points P1 to P4 are formed on the lumbar region of a pregnant woman and distilled water 15 that is sterilized is administered, which is a simpler procedure than epidural anesthesia. Can be carried out.
  • the analgesic effect of this method appears in about 30 seconds after administration, lasts up to about 2 hours, and repeated administration of distilled water is also possible.
  • the lumen 14 of the medical device 100 is configured to be pre-filled with sterilized distilled water 15 before use. Therefore, it is not necessary to fill the inner cavity 14 with the distilled water 15 during the procedure and the time required for the filling work. Therefore, it is possible to improve the workability of a worker such as a doctor and quickly reduce the pain of a pregnant woman at the time of delivery.
  • the sterilized distilled water 15 is injected into the puncture points P1 to P4 on the waist of the pregnant woman. Since it is considered that an anesthesiologist such as epidural anesthesia is not required to handle sterile distilled water, even if it is a medical institution without an expert anesthesiologist with specialized knowledge and experience compared to epidural anesthesia The method for reducing pain according to the embodiment can be performed. Further, since sterilized distilled water 15 is cheaper than anesthesia used for epidural anesthesia, it can also contribute to reducing the economical burden on pregnant women who want to reduce pain associated with uterine contraction during childbirth. ..
  • the medical device 100 in which the lumen 14 is filled with distilled water 15 that has been sterilized in advance, it is possible to reduce the pain in the lower back caused by a pregnant woman during childbirth.
  • the distilled water 15 when the distilled water 15 is injected into the puncture points P1 to P4, the pregnant woman temporarily feels some pain during the injection of the distilled water 15 due to the difference between the living body and the osmotic pressure. Therefore, physiological saline or the like may be added to sterilized distilled water instead of the distilled water 15. This can be expected to maintain the above-described pain relief (pain relief) effect while reducing the osmotic pressure stimulation.
  • the liquid to be injected into the puncture points P1 to P4 on the lumbar region of a pregnant woman may be a liquid other than sterile distilled water as long as it can be injected by a person other than an anesthesiologist.
  • FIG. 6 is a partial cross-sectional view showing a modified example of the syringe body 10 of the medical device 100 shown in FIG.
  • the medical device 100 has been described above as including the syringe body 10 including the pusher 11 and the outer cylinder 12, the medical device 100 is not limited to this.
  • the syringe body 10a of the medical device 100a is provided with a plurality of engaging portions 11b such as a plurality of convex portions in the longitudinal direction on the outer surface of the pusher 11a, and the inner surface of the outer cylinder 12a. May be provided with a plurality of engaged portions 12b that engage with the plurality of engaging portions 11b.
  • the plurality of engaged portions 12b are provided inside the outer cylinder 12a having the inner cavity 14. As described above, the distilled water 15 is injected into the puncture points P1 to P4 in the skin of the waist. If one medical device is used at one place, four medical devices are needed to puncture the puncture points P1 to P4.
  • the pusher 11a is moved by using the plurality of engaging portions 11b and the plurality of engaged portions 12b, even if the pusher 11a is moved toward the injection needle 27, one engaging portion 11b is obtained.
  • the movement is temporarily stopped by engaging with the adjacent engaged portions 12b.
  • the user of the medical device 100a such as a doctor, can recognize (recognize) that the engaging portion 11b is engaged with the adjacent engaged portion 12b by the sense (tactile sense) of the hand.
  • distilled water 15 can be injected into multiple puncture sites with one medical device. Therefore, it is possible to reduce the number of medical instruments required for injecting distilled water into the puncture points P1 to P4, and reduce the storage space and waste. Further, it is possible to continuously administer to a plurality of puncture sites with a single medical device, which can be expected to shorten the time of the procedure.
  • FIG. 6 three engaging portions 11b and engaged portions 12b each having a tapered shape are provided.
  • the shapes and numbers of the engaging portions and the engaged portions are not limited to those shown in FIG. 6 as long as the amount of movement of the engaging portions toward the injection needle can be regulated by engaging with the adjacent engaged portions.

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Abstract

[Problem] To provide a method for reducing the pain associated with childbirth without using epidural anesthesia. [Solution] In this method for reducing pain, a medical instrument 100 includes an inner cavity 14 and an injection needle 27, and the inner cavity of the instrument is preloaded with distilled water 15. The needle 27 of the medical instrument is used to form puncture sections P1-P4 intradermally in the lower back of a person who is giving birth, and the disinfected distilled water is injected from the inner cavity of the medical instrument to the puncture sections, thereby imparting stimulation to a nerve that transmits faster than the nerve stimulated by uterine contraction.

Description

疼痛軽減方法、液体及び医療器具Pain relief methods, liquids and medical devices
　本発明は、疼痛軽減方法、液体及び医療器具に関する。 The present invention relates to a method for reducing pain, a liquid and a medical device.
　妊婦は、自然分娩による出産の際に多大なる痛みを経験することから、その痛みを緩和する方法について鋭意研究がなされている。一般的な自然分娩においては、分娩時に陣痛が始まるが、この陣痛が強い腰痛として感知されることが少なくない。このような腰痛は、いわゆる一般的な腰痛と異なり、子宮が収縮することによって起きるものである。この腰痛によって妊婦は起立困難になる場合もあり、妊婦の体力消耗の大きな原因となっている。 Pregnant women experience a great deal of pain during childbirth due to natural birth, and therefore intensive research has been conducted on methods to alleviate the pain. In general natural labor, labor pain begins during labor, and this labor pain is often perceived as strong back pain. Such low back pain is caused by contraction of the uterus, unlike so-called general low back pain. This backache may make it difficult for a pregnant woman to stand up, which is a major cause of physical exhaustion of the pregnant woman.
　このような分娩時の痛みを軽減する方法として、和痛方法ではアロマテラピーやマッサージがあるものの、その効果は曖昧である。また、無痛分娩には陰部神経ブロックや硬膜外麻酔による局所麻酔又は静脈点滴による全身麻酔があり、一般的には硬膜外麻酔が行われ、硬膜外麻酔が実施できない場合に静脈点滴が実施される。硬膜外麻酔に関する技術として、特許文献１には硬膜外麻酔を行う際に重炭酸塩や硝酸塩、又はリン酸塩等を含む組成物を投与する技術が開示されている。 Although there are aromatherapy and massage in the Japanese pain method as a method to reduce such pain during labor, the effect is vague. Painless labor includes local anesthesia with pudendal nerve block or epidural anesthesia or general anesthesia with intravenous drip, and epidural anesthesia is generally performed, and intravenous drip is given when epidural anesthesia cannot be performed. Be implemented. As a technique related to epidural anesthesia, Patent Document 1 discloses a technique of administering a composition containing bicarbonate, nitrate, phosphate or the like when performing epidural anesthesia.
特表２０１７－５０８００４号公報Special table 2017-508004 gazette
　特許文献１のような硬膜外麻酔を用いる方法のメリットは、除痛効果が高く、母体の意識も明瞭で、麻酔薬が胎児に影響することもなく、そのまま帝王切開を行える等が挙げられる。ただし、硬膜外麻酔のデメリットには麻酔中毒等の重大な合併症が起こる可能性がある。そのため、硬膜外麻酔を実施する医療機関では経験豊富な麻酔科医等の医師の存在や緊急時に対応できる施設体制等が必要となる。しかし、わが国において麻酔科医の数は不足しており、全ての妊婦に対して経験豊富な麻酔科医が必ずしも担当できるとは限らない。 The merit of the method using epidural anesthesia as in Patent Document 1 is that the pain relief effect is high, the consciousness of the mother is clear, the anesthetic does not affect the fetus, and caesarean section can be performed as it is. .. However, the demerit of epidural anesthesia may be serious complications such as anesthesia poisoning. Therefore, a medical institution that performs epidural anesthesia needs to have a doctor such as an experienced anesthesiologist and a facility system that can respond in an emergency. However, the number of anesthesiologists in Japan is insufficient, and an experienced anesthesiologist cannot always handle all pregnant women.
　そこで本発明は、硬膜外麻酔によらずに出産時の腰部の痛みを軽減できる疼痛軽減方法を提供することを目的とする。 Therefore, an object of the present invention is to provide a pain reducing method that can reduce the pain in the lower back during delivery without resorting to epidural anesthesia.
　上記目的を達成する本発明に係る疼痛軽減方法は、内腔と穿刺部とを備え、前記内腔に液体が予め充填された医療器具の前記穿刺部を用いて分娩中の妊婦の腰部における皮内に穿刺箇所を形成する。そして、前記内腔から前記穿刺箇所に前記液体を注入することによって子宮収縮により刺激される神経よりも伝導速度の速い神経に刺激を付与する。また、本発明は上記疼痛軽減方法に用いられる液体である。また、本発明は上記内腔に液体が予め充填された医療器具である。 A method for reducing pain according to the present invention that achieves the above-mentioned object, comprising a lumen and a puncture portion, and using the puncture portion of a medical device in which the lumen is pre-filled with a liquid, skin on the lumbar region of a pregnant woman during delivery Form a puncture site inside. Then, by injecting the liquid from the lumen into the puncture site, stimulation is given to a nerve having a faster conduction velocity than the nerve stimulated by uterine contraction. Further, the present invention is a liquid used in the above-mentioned method for reducing pain. The present invention is also a medical device in which the above-mentioned lumen is pre-filled with a liquid.
　本発明に係る疼痛軽減方法、疼痛軽減方法に用いられる液体及び医療器具によれば、医療器具の内腔から妊婦の腰部における皮内に液体を注入することによって、硬膜外麻酔によらずに分娩時における妊婦の腰部の痛みを軽減することができる。 According to the pain reducing method, the liquid and the medical device used in the pain reducing method according to the present invention, by injecting the liquid into the skin in the lumbar region of a pregnant woman from the lumen of the medical device, without depending on epidural anesthesia. The pain in the lower back of a pregnant woman during delivery can be reduced.
本発明の一実施形態に係る疼痛軽減方法に用いられる医療器具を分解して示す正面図である。It is a front view which decomposes | disassembles and shows the medical device used for the pain reduction method which concerns on one Embodiment of this invention. 図１に示す医療器具における穿刺部の先端を示す拡大図である。It is an enlarged view which shows the front-end | tip of the puncture part in the medical device shown in FIG. 図１に示す医療器具の部分断面図である。It is a partial cross section figure of the medical device shown in FIG. 図１に示す医療器具によって穿刺される人体の穿刺箇所を示す腰部付近の図である。FIG. 2 is a diagram in the vicinity of a waist showing a puncture site of a human body punctured by the medical device shown in FIG. 1. 本発明の一実施形態に係る疼痛軽減方法を示すフローチャートである。3 is a flowchart showing a pain reducing method according to an embodiment of the present invention. 図１におけるシリンジ本体の変形例を示す部分断面図である。It is a fragmentary sectional view which shows the modification of the syringe main body in FIG.
　以下、添付した図面を参照しながら、本発明の実施形態を説明する。図１は、本発明の一実施形態に係る疼痛軽減方法に用いられる医療器具１００を分解して示す正面図である。図２は、図１に示す医療器具１００の穿刺部の先端を示す拡大図である。図３は図１に示す医療器具１００の部分断面図である。本実施形態に係る疼痛軽減方法は、自然分娩等によって出産を行う妊婦の腰痛等を軽減するために用いられる。まず、疼痛軽減方法の説明にあたり、本実施形態に係る疼痛軽減方法に用いられる医療器具１００について説明する。 Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. FIG. 1 is an exploded front view showing a medical device 100 used in a pain reducing method according to an embodiment of the present invention. FIG. 2 is an enlarged view showing the tip of the puncture part of the medical device 100 shown in FIG. FIG. 3 is a partial cross-sectional view of the medical device 100 shown in FIG. The pain reducing method according to the present embodiment is used to reduce back pain and the like of a pregnant woman who gives birth by natural delivery or the like. First, in explaining the pain reducing method, the medical device 100 used in the pain reducing method according to the present embodiment will be described.
　（医療器具）
　医療器具１００は、図１に示すようにシリンジ本体１０と、注射針組立体２０と、を有する。 (Medical equipment)
The medical device 100 includes a syringe body 10 and a needle assembly 20 as shown in FIG.
　シリンジ本体１０は、図１に示すように押し子１１と、外筒１２と、ロック機構１６と、筒先１７と、キャップ１８と、を備える。押し子１１は、内腔１４に充填された液体を後述する注射針２７に向けて押出すように構成している。内腔１４は外筒１２の内部に設けるように構成している。押し子１１は、外筒１２の内腔１４に挿入可能に構成している。押し子１１は、先端にゴム等によって形成されたガスケット１３が取り付けられ、ガスケット１３とともに外筒１２の内腔１４に挿入可能に構成している。 As shown in FIG. 1, the syringe main body 10 includes a pusher 11, an outer cylinder 12, a lock mechanism 16, a cylinder tip 17, and a cap 18. The pusher 11 is configured to push the liquid filled in the inner cavity 14 toward an injection needle 27 described below. The inner cavity 14 is configured to be provided inside the outer cylinder 12. The pusher 11 is configured to be insertable into the inner cavity 14 of the outer cylinder 12. A gasket 13 made of rubber or the like is attached to the tip of the pusher 11, and the pusher 11 can be inserted into the inner cavity 14 of the outer cylinder 12 together with the gasket 13.
　押し子１１の基端は、図１に示すように外筒１２から露出するように構成している。外筒１２の内腔１４には、滅菌された蒸留水１５が使用前に予め液密に封入されるように構成している。滅菌された蒸留水１５は、本明細書において妊婦の腰部における皮内に注入（投与）される液体に相当する。本明細書における「液体」とは、硬膜外麻酔のように麻酔科医でなくても出産時に妊婦への投与が可能なものを意味する。 The base end of the pusher 11 is configured to be exposed from the outer cylinder 12 as shown in FIG. In the inner cavity 14 of the outer cylinder 12, sterilized distilled water 15 is preliminarily liquid-tightly sealed before use. The sterilized distilled water 15 corresponds herein to a liquid that is injected (administered) intradermally in the lumbar region of a pregnant woman. As used herein, the term “liquid” means a liquid that can be administered to a pregnant woman at birth without having to be an anesthesiologist, such as epidural anesthesia.
　本実施形態において滅菌した蒸留水１５は、蒸留水に滅菌処理を施していれば特に限定されないが、例示すれば逆浸透圧法と蒸留法により製造したものや、蒸留水を高圧蒸気滅菌したもの等を挙げることができる。筒先１７は、外筒１２から延在しており、図３に示すように内部に基端側よりも径を小さく構成した内腔１４を設けている。 The distilled water 15 sterilized in the present embodiment is not particularly limited as long as distilled water is subjected to a sterilization treatment. For example, distilled water 15 produced by a reverse osmosis method and a distillation method, distilled water subjected to high pressure steam sterilization, etc. Can be mentioned. The barrel tip 17 extends from the outer barrel 12, and as shown in FIG. 3, the barrel tip 17 is provided therein with an inner cavity 14 having a diameter smaller than that of the proximal end side.
　ロック機構１６は、図３に示すように本実施形態においてキャップ１８と螺合可能な雌ねじによって構成している。キャップ１８には雄ねじが設けられ、キャップ１８の雄ねじとロック機構１６に係る雌ねじとを螺合させることによって内腔１４に収容された蒸留水１５が封止されるように構成している。注射針組立体２０は、図１に示すように係合筒２２と、弾性体２３と、針ハブ２４と、安定部２６と、注射針２７（穿刺部に相当）と、を備える。係合筒２２は、図３に示すようにロック機構１６に係る雌ねじと螺合可能な雄ねじを外周面に設けている。針ハブ２４は、注射針組立体２０の先端において注射針２７を保持するように構成している。弾性体２３は、図３に示すようにロック機構１６と係合筒２２とが係合することによって筒先１７及び針ハブ２４の間に設けられた隙間を埋めるように構成している。注射針２７は、針先から針基端に連通する針穴が設けられ、針先に刃面を備えた針管を設けている。注射針２７は、針ハブ２４の調整部２５から突出するように構成している。安定部２６は、針ハブ２４の針先において中空の筒状に形成し、調整部２５を径方向外方から包囲する
ように構成している。 As shown in FIG. 3, the lock mechanism 16 is formed of a female screw that can be screwed into the cap 18 in this embodiment. A male screw is provided on the cap 18, and the distilled water 15 contained in the inner cavity 14 is sealed by screwing the male screw of the cap 18 and the female screw of the lock mechanism 16 together. As shown in FIG. 1, the injection needle assembly 20 includes an engagement tube 22, an elastic body 23, a needle hub 24, a stabilizing portion 26, and an injection needle 27 (corresponding to a puncturing portion). As shown in FIG. 3, the engagement cylinder 22 is provided with a male screw which can be screwed with a female screw of the lock mechanism 16 on the outer peripheral surface. The needle hub 24 is configured to hold the injection needle 27 at the tip of the injection needle assembly 20. As shown in FIG. 3, the elastic body 23 is configured to fill a gap provided between the barrel tip 17 and the needle hub 24 by the engagement of the lock mechanism 16 and the engagement barrel 22. The injection needle 27 is provided with a needle hole communicating from the needle tip to the needle base end, and a needle tube having a blade surface is provided at the needle tip. The injection needle 27 is configured to project from the adjusting portion 25 of the needle hub 24. The stabilizing portion 26 is formed in a hollow cylindrical shape at the needle tip of the needle hub 24, and is configured to surround the adjusting portion 25 from the outside in the radial direction.
　図２に示すように注射針２７の針先から調整部２５の針先側端面までの長さＬ１は、最長で２ｍｍ程度であり、針胴長Ｌ２は最短で１ｍｍ程度で、２６～２５ゲージ（直径０．４５～０．１５ｍｍに相当）となるように構成している。 As shown in FIG. 2, the length L1 from the needle tip of the injection needle 27 to the needle tip side end surface of the adjusting portion 25 is about 2 mm at the longest, and the needle barrel length L2 is about 1 mm at the shortest, which is 26 to 25 gauge. (Corresponding to a diameter of 0.45 to 0.15 mm).
　注射針組立体２０は、図１に示すように使用直前まで一体に構成された包装容器２１ｂと包装蓋２１ａによって包囲され、包装蓋２１ａを包装容器２１ｂから剥離して分離することによって取り出し可能に構成している。 As shown in FIG. 1, the injection needle assembly 20 is surrounded by a packaging container 21b and a packaging lid 21a which are integrally configured until just before use, and can be taken out by separating the packaging lid 21a from the packaging container 21b and separating the packaging lid 21a. I am configuring.
　医療器具１００を構成する部材の材料は特に限定されないが、例示すれば以下のようになる。外筒１２、ロック機構１６、筒先１７、係合筒２２、針ハブ２４、調整部２５及び安定部２６はポリプレロピレン、ポリエチレン、シクロオレフィンポリマー等によって構成できる。 The material of the member forming the medical device 100 is not particularly limited, but the following is an example. The outer cylinder 12, the lock mechanism 16, the cylinder tip 17, the engagement cylinder 22, the needle hub 24, the adjusting portion 25, and the stabilizing portion 26 can be made of polypropylene, polyethylene, cycloolefin polymer, or the like.
　ガスケット１３及び弾性体２３については、天然ゴム、シリコーンゴムのような各種ゴム材料や、ポリウレタン系、スチレン系等の各種熱可塑性エラストマー、或いはそれらの混合物等によって構成できる。注射針２７については、ステンレス鋼、アルミニウム、アルミニウム合金、チタン、チタン合金その他の金属によって構成することができる。 The gasket 13 and the elastic body 23 can be made of various rubber materials such as natural rubber and silicone rubber, various thermoplastic elastomers such as polyurethane series and styrene series, or a mixture thereof. The injection needle 27 can be made of stainless steel, aluminum, aluminum alloy, titanium, titanium alloy or other metal.
　（疼痛軽減方法）
　次に本実施形態に係る疼痛軽減方法について説明する。図４は図１に示す医療器具１００によって穿刺される人体の穿刺箇所を示す腰部付近の（背面）図である。図５は、本発明の一実施形態に係る疼痛軽減方法について示すフローチャートである。 (Pain relief method)
Next, the pain reducing method according to the present embodiment will be described. FIG. 4 is a (back) view in the vicinity of the waist showing a puncture site of a human body to be punctured by the medical device 100 shown in FIG. FIG. 5 is a flowchart showing a pain reducing method according to an embodiment of the present invention.
　まず、内腔１４に滅菌した０．１ｍｌの蒸留水１５が予め充填された医療器具１００を用意する。次に、妊婦は医師や助産師の指示を受けて公知の分娩台（図示省略）に仰臥等の姿勢で横になる（ＳＴ１）。そして、一時的に背中の中でも穿刺箇所Ｐ１～Ｐ４である腰部付近が医師に対して対向するように姿勢を変える。 First, prepare the medical device 100 in which the lumen 14 is pre-filled with 0.1 ml of sterilized distilled water 15. Next, the pregnant woman lays down on a known delivery table (not shown) in a supine posture in response to instructions from a doctor or midwife (ST1). Then, the posture is temporarily changed so that the vicinity of the waist, which is the puncture points P1 to P4, faces the doctor even in the back.
　次に、医師は包装蓋２１ａを包装容器２１ｂから剥離して分離し、包装容器２１ｂから注射針組立体２０を取り出す。そして、シリンジ本体１０のキャップ１８を筒先１７から取り外し、筒先１７に注射針組立体２０の係合筒２２の雄ねじとロック機構１６の雌ねじとを螺合する。これにより、注射針組立体２０がシリンジ本体１０に取り付けられる。そして、筒先１７と針ハブ２４との間の隙間が弾性体２３の弾性変形によって隙間なく埋められ、液密状態となる。 Next, the doctor peels and separates the packaging lid 21a from the packaging container 21b, and takes out the injection needle assembly 20 from the packaging container 21b. Then, the cap 18 of the syringe main body 10 is removed from the barrel tip 17, and the male screw of the engagement barrel 22 of the injection needle assembly 20 and the female screw of the lock mechanism 16 are screwed onto the barrel tip 17. Thereby, the injection needle assembly 20 is attached to the syringe body 10. Then, the gap between the cylinder tip 17 and the needle hub 24 is filled without any gap by the elastic deformation of the elastic body 23, resulting in a liquid-tight state.
　次に、医師は、図４に示すように注射針組立体２０の注射針２７の針先を穿刺部位である腰部付近の穿刺箇所Ｐ１～Ｐ４に向ける。次に、医師は、妊婦の腰部付近と対向した状態において医療器具１００を用いて滅菌した蒸留水１５を略０．１ｍｌ、妊婦の脊柱上を除く左右２箇所、計４箇所（図４の穿刺箇所Ｐ１～Ｐ４参照）に皮内投与（注入）する（ＳＴ２）。 Next, the doctor directs the needle tip of the injection needle 27 of the injection needle assembly 20 to the puncture points P1 to P4 near the waist, which is the puncture site, as shown in FIG. Next, the doctor has about 0.1 ml of distilled water 15 sterilized by using the medical device 100 in a state facing the vicinity of the lumbar region of the pregnant woman, and two places on the left and right except on the spinal column of the pregnant woman, for a total of four places (the puncture in FIG. 4). It is intradermally administered (injected) at points P1 to P4) (ST2).
　次に、医師等は、医療器具１００を注射針２７が皮膚３０に対して垂直となるように押し付ける。これにより、注射針２７の針先が皮膚３０に穿刺される。それとともに安定部２６が皮膚３０の皮膚表皮３３を押し当て、調整部２５が皮膚表皮３３に接触する結果、調整部２５と安定部２６によって皮膚表皮３３の表面が引っ張られ、針ハブ２４によって医療器具１００が穿刺箇所に対して固定（安定化）される。 Next, the doctor or the like presses the medical device 100 so that the injection needle 27 is perpendicular to the skin 30. As a result, the needle tip of the injection needle 27 is punctured into the skin 30. At the same time, the stabilizing unit 26 presses the skin epidermis 33 of the skin 30, and the adjusting unit 25 contacts the skin epidermis 33. As a result, the surface of the skin epidermis 33 is pulled by the adjusting unit 25 and the stabilizing unit 26, and the medical treatment is performed by the needle hub 24. The device 100 is fixed (stabilized) to the puncture site.
　注射針２７は、針先の鋭利な刃面によって皮膚表皮３３を貫通し、刃面の針穴の開口が丁度皮膚上層部の皮内３２のうち、皮膚表皮３３の表面から１～４ｍｍの比較的浅い皮内標的部位に達するが、皮下組織３１には達しない位置となる。この状態で押し子１１を押し切って滅菌された蒸留水１５を注入する。これにより、皮膚表皮３３の表面より１～４ｍｍの深さである皮内３２へ滅菌された蒸留水１５が到達する。 The injection needle 27 penetrates the skin epidermis 33 by the sharp blade surface of the needle tip, and the opening of the needle hole of the blade surface is 1 to 4 mm from the surface of the skin epidermis 33, just inside the skin 32 of the upper skin layer. The target position is a shallow intradermal target site, but not the subcutaneous tissue 31. In this state, the pusher 11 is pushed down to inject sterilized distilled water 15. As a result, the sterilized distilled water 15 reaches the inside of the skin 32 having a depth of 1 to 4 mm from the surface of the skin epidermis 33.
　蒸留水１５を投与した後は、妊婦が分娩台の上において仰臥位となり、左右の大腿及び下腿を離間するように開いて分娩台の足置きに載せる。そして、医師又は助産師の指示に従って、上体を起こすなど体位を変化させたり、いきんだり、深呼吸したりしながら、子宮口より胎児を分娩する（ＳＴ３）。 After administration of distilled water 15, the pregnant woman should be in the supine position on the delivery table, and the left and right thighs and lower legs should be opened apart and placed on the foot rest of the delivery table. Then, according to the instruction of the doctor or midwife, the fetus is delivered from the uterine ostium while changing the body position such as raising the upper body, breathing, or taking a deep breath (ST3).
　本方法において、腰部の穿刺箇所Ｐ１～Ｐ４の皮内３２に蒸留水１５を投与した後は、投与部位に一時的に痛みを感じるものの、その痛みは略３０秒程度～数分程度で消失し、除痛効果を発現する。本実施形態に係る疼痛軽減方法は、硬膜外麻酔による方法と比べて除痛効果が早く発現することが期待できる。 In this method, after administration of distilled water 15 to the intradermal skin 32 at the puncture points P1 to P4 on the lumbar region, temporary pain is felt at the administration site, but the pain disappears in about 30 seconds to several minutes. , Develops analgesic effect. The pain reducing method according to the present embodiment can be expected to exhibit the pain relief effect earlier than the method using epidural anesthesia.
　また、本実施形態に係る疼痛軽減方法は、無処置やマッサージ等と比較して有意な除痛効果が期待できる。除痛の持続時間は最大２時間程度であり、蒸留水１５の繰り返しの投与も可能である。 Moreover, the pain reduction method according to the present embodiment can be expected to have a significant pain relief effect as compared with no treatment or massage. The duration of pain relief is about 2 hours at maximum, and repeated administration of distilled water 15 is also possible.
　本方法に基づく疼痛軽減方法は、いわゆるゲートコントロール理論に基づくと考えられる。すなわち、出産の際の陣痛における子宮収縮は、内臓痛覚であり、Ｃ神経線維を介する。Ｃ神経線維は、比較的細い無髄神経であり、伝導速度は遅い。これに対して、より太く伝導速度の速い神経線維（有髄神経）であるＡβ神経線維（触覚・圧覚）やＡδ神経線維（体性痛覚）を刺激することによって内臓痛覚を抑制する。これにより、内臓痛覚である子宮収縮による痛みが緩和される。 The pain reduction method based on this method is considered to be based on the so-called gate control theory. That is, the uterine contraction in labor during labor is visceral pain sensation and is mediated by C nerve fiber. The C nerve fiber is a relatively thin unmyelinated nerve and has a slow conduction velocity. On the other hand, the visceral pain sensation is suppressed by stimulating the Aβ nerve fibers (tactile / pressure sensation) and Aδ nerve fibers (somatic pain sensation), which are thicker and faster in conduction velocity (myelinated nerves). This alleviates the pain caused by uterine contraction, which is a visceral pain sensation.
　疼痛軽減（除痛）効果を得るためには皮膚に存在する神経を刺激する必要がある。このような神経は、皮下組織よりも皮膚（主に真皮層）に多く分布している。また、このような刺激は、薬剤の投与量（物理的な皮膚の圧迫）、浸透圧（痛み）、温度（冷たい、熱い）等によってもたらされる。 It is necessary to stimulate the nerves existing on the skin to obtain the pain relief (pain relief) effect. Such nerves are distributed more in the skin (mainly the dermis layer) than in the subcutaneous tissue. Further, such irritation is brought about by the dose of the drug (physical compression of the skin), osmotic pressure (pain), temperature (cold, hot), and the like.
　本方法によれば、妊婦はいきむことも可能である。本発明に係る疼痛軽減方法によれば、妊婦の意識に影響を与えず、行動を制限することもない。そのため、蒸留水１５の注入後の分娩の進行に影響を与えないようにすることができる。また、本方法は、滅菌した蒸留水１５を上述した箇所に皮内要与する程度であり、人手が必要であるのは投与時程度である。さらに、硬膜外麻酔のように専門知識を備えた医師でなくても処置が可能である。 According to this method, pregnant women can also live. According to the pain reduction method of the present invention, the consciousness of a pregnant woman is not affected and the behavior is not restricted. Therefore, it is possible to prevent the progress of labor after the injection of the distilled water 15 from being affected. Further, in this method, sterilized distilled water 15 is applied intradermally to the above-mentioned location, and manual labor is required only during administration. Furthermore, it is possible to perform treatment without requiring a doctor having specialized knowledge such as epidural anesthesia.
　また、本方法は、母子に対して安全であり、少なくとも子供への副作用はない。さらに、本方法は、硬膜外麻酔のような麻酔を必要とせず、処置に必要な費用を安くすることができる。また、本実施形態に係る疼痛軽減方法は、ラマーズ法やマッサージ、アロマテラピー等の他の疼痛軽減方法との併用も可能である。 Also, this method is safe for mothers and children, and at least has no side effects on children. In addition, the method does not require anesthesia such as epidural anesthesia and can reduce the cost of the procedure. In addition, the pain reducing method according to the present embodiment can be used in combination with other pain reducing methods such as Lammers method, massage, and aromatherapy.
　以上、説明したように本実施形態に係る疼痛軽減方法は、内腔１４と注射針２７とを備え、内腔１４に蒸留水１５が予め充填された医療器具１００の注射針２７を用いて分娩中の妊婦の腰部に穿刺箇所Ｐ１～Ｐ４を形成する。そして、医療器具１００の内腔１４から穿刺箇所Ｐ１～Ｐ４の皮内に滅菌された蒸留水１５を注入（投与）する。これにより、子宮収縮により刺激される神経よりも伝導速度の速い神経に刺激が付与される。 As described above, the pain reducing method according to the present embodiment includes the lumen 14 and the injection needle 27, and the delivery is performed using the injection needle 27 of the medical device 100 in which the lumen 14 is preliminarily filled with distilled water 15. Puncture points P1 to P4 are formed on the waist of the pregnant woman. Then, sterilized distilled water 15 is injected (administered) from the inner cavity 14 of the medical device 100 into the skin at the puncture points P1 to P4. As a result, stimulation is imparted to nerves having a faster conduction velocity than nerves stimulated by uterine contractions.
　本方法以外に出産時の妊婦の子宮収縮による痛みを軽減する方法には硬膜外麻酔がある。硬膜外麻酔による疼痛軽減効果は高く、母体の意識も明瞭で、麻酔が胎児に影響することはなく、そのまま帝王切開などもできると言われている。ただし、硬膜外麻酔は、いきみにくくなり、場合によっては発熱や低血圧となり、麻酔薬中毒等の重大な合併症を引き起こし、最悪の場合には死亡に至る可能性もある。 In addition to this method, epidural anesthesia is another method for reducing the pain caused by uterine contractions in pregnant women at birth. It is said that epidural anesthesia is highly effective in reducing pain, the maternal consciousness is clear, the anesthesia does not affect the fetus, and caesarean section can be performed as it is. However, epidural anesthesia becomes difficult to move, and in some cases, fever and hypotension may occur, which may cause serious complications such as anesthetic poisoning and, in the worst case, death.
　そのため、硬膜外麻酔を実施するには麻酔薬の厳格な管理が要求されたり、専門知識を有する麻酔科医が必要とされ、さらに緊急時に対応可能な施設体制も必要とされる。日本では上述のように麻酔科医が十分いるとは言い難く、硬膜外麻酔に伴う夫婦の費用負担も軽いとは言い難い。 Therefore, in order to perform epidural anesthesia, strict management of anesthetics is required, an anesthesiologist with specialized knowledge is required, and a facility system capable of responding in an emergency is also required. As mentioned above, it is hard to say that there are sufficient anesthesiologists in Japan, and it is hard to say that the cost burden for the couple due to epidural anesthesia is light.
　これに対して、本実施形態に係る疼痛軽減方法では、妊婦の腰部に穿刺箇所Ｐ１～４を形成して滅菌した蒸留水１５を投与する程度であり、硬膜外麻酔に比べて簡便に手技を実施することができる。また、本方法による除痛効果は、投与後略３０秒程度で発現し、最大で２時間程度持続し、繰り返しの蒸留水投与も可能である。 On the other hand, in the method of reducing pain according to the present embodiment, the puncture points P1 to P4 are formed on the lumbar region of a pregnant woman and distilled water 15 that is sterilized is administered, which is a simpler procedure than epidural anesthesia. Can be carried out. In addition, the analgesic effect of this method appears in about 30 seconds after administration, lasts up to about 2 hours, and repeated administration of distilled water is also possible.
　さらに麻酔科医も不要で、ラマーズ法やマッサージ、及びアロマテラピー等の他の疼痛軽減方法との併用も可能である。また、本方法によれば、投与後に妊婦の意識にも影響を与えず、行動を制限することもなく、自然分娩が可能となり、その後の分娩の進展にも影響を与えないようにすることができる。 Furthermore, it does not require an anesthesiologist and can be used in combination with other pain relief methods such as lammers method, massage, and aromatherapy. In addition, according to this method, it is possible to allow natural delivery without affecting the consciousness of pregnant women after administration and without restricting their behavior, and to prevent the progress of subsequent delivery from being affected. it can.
　また、本方法では妊婦の腰部の皮内３２に穿刺箇所Ｐ１～Ｐ４を形成することによって出産時の子宮収縮による痛みを軽減することができる。 Also, in this method, by forming the puncture points P1 to P4 in the skin 32 of the lumbar region of a pregnant woman, pain due to uterine contraction during childbirth can be reduced.
　また、医療器具１００の内腔１４には滅菌された蒸留水１５が使用前に予め充填するように構成している。そのため、手技の際に内腔１４に蒸留水１５を充填する作業と充填作業にかかる時間が不要になる。そのため、医師等の作業者の作業性を向上させるとともに、出産時に生じる妊婦の痛みを速やかに軽減することができる。 Also, the lumen 14 of the medical device 100 is configured to be pre-filled with sterilized distilled water 15 before use. Therefore, it is not necessary to fill the inner cavity 14 with the distilled water 15 during the procedure and the time required for the filling work. Therefore, it is possible to improve the workability of a worker such as a doctor and quickly reduce the pain of a pregnant woman at the time of delivery.
　また、本実施形態に係る疼痛軽減方法によれば、妊婦の腰部の穿刺箇所Ｐ１～Ｐ４には滅菌された蒸留水１５を注入している。滅菌蒸留水の取り扱いには硬膜外麻酔のような麻酔科医が不要と考えられるため、硬膜外麻酔に比べて専門知識や経験豊富な麻酔科医のいない医療機関であっても本実施形態に係る疼痛軽減方法を実施することができる。また、滅菌された蒸留水１５は硬膜外麻酔に用いられる麻酔よりも安価であるため、出産時の子宮収縮に伴う疼痛軽減を望む妊婦への経済的な負担を軽減することにも寄与できる。 Further, according to the pain reducing method according to the present embodiment, the sterilized distilled water 15 is injected into the puncture points P1 to P4 on the waist of the pregnant woman. Since it is considered that an anesthesiologist such as epidural anesthesia is not required to handle sterile distilled water, even if it is a medical institution without an expert anesthesiologist with specialized knowledge and experience compared to epidural anesthesia The method for reducing pain according to the embodiment can be performed. Further, since sterilized distilled water 15 is cheaper than anesthesia used for epidural anesthesia, it can also contribute to reducing the economical burden on pregnant women who want to reduce pain associated with uterine contraction during childbirth. ..
　また、本方法によれば、上記医療器具に滅菌した蒸留水１５を用いることによって出産時の子宮収縮に伴う妊婦の疼痛軽減を図ることができる。 In addition, according to the present method, it is possible to reduce the pain of a pregnant woman due to uterine contraction during childbirth by using sterilized distilled water 15 for the medical device.
　また、本実施形態によれば、内腔１４に予め滅菌された蒸留水１５を充填した医療器具１００を用いることによって、出産時に妊婦に生じる腰部の痛みを軽減することができる。 Further, according to the present embodiment, by using the medical device 100 in which the lumen 14 is filled with distilled water 15 that has been sterilized in advance, it is possible to reduce the pain in the lower back caused by a pregnant woman during childbirth.
　なお、本発明は上述した実施形態のみに限定されず、特許請求の範囲において種々の変更が可能である。上記では自然分娩における妊婦の痛みを軽減する実施形態について説明したが、これに限定されない。上記以外にも硬膜外麻酔を用いなければ、妊婦に陣痛促進剤等を投与してもよい。 Note that the present invention is not limited to the above-described embodiments, and various modifications can be made within the scope of the claims. Although the above has described the embodiment for reducing the pain of a pregnant woman during spontaneous delivery, the embodiment is not limited thereto. In addition to the above, unless epidural anesthesia is used, a labor promoting agent or the like may be administered to a pregnant woman.
　また、蒸留水１５を穿刺箇所Ｐ１～Ｐ４に注入する際には生体と浸透圧との差によって、蒸留水１５の注入時に妊婦は若干の痛みを一時的に感じる。そのため、蒸留水１５の代わりとして、滅菌された蒸留水に生理食塩水等を加えてもよい。これにより、浸透圧による刺激を下げつつ、上述した疼痛軽減（除痛）効果を維持することが期待できる。また、妊婦の腰部における穿刺箇所Ｐ１～Ｐ４に注入する液体は、麻酔科医以外の者でも注入が可能であれば、滅菌蒸留水以外の液体であってもよい。 Also, when the distilled water 15 is injected into the puncture points P1 to P4, the pregnant woman temporarily feels some pain during the injection of the distilled water 15 due to the difference between the living body and the osmotic pressure. Therefore, physiological saline or the like may be added to sterilized distilled water instead of the distilled water 15. This can be expected to maintain the above-described pain relief (pain relief) effect while reducing the osmotic pressure stimulation. The liquid to be injected into the puncture points P1 to P4 on the lumbar region of a pregnant woman may be a liquid other than sterile distilled water as long as it can be injected by a person other than an anesthesiologist.
　図６は、図１における医療器具１００のシリンジ本体１０の変形例を示す部分断面図である。上記では医療器具１００が押し子１１や外筒１２を備えるシリンジ本体１０を有すると説明したが、これに限定されない。上記以外にも図６に示すように医療器具１００ａのシリンジ本体１０ａは、押し子１１ａの外側面に長手方向に複数の凸部等の複数の係合部１１ｂを設け、外筒１２ａの内表面には複数の係合部１１ｂと係合する複数の被係合部１２ｂを設けてもよい。 FIG. 6 is a partial cross-sectional view showing a modified example of the syringe body 10 of the medical device 100 shown in FIG. Although the medical device 100 has been described above as including the syringe body 10 including the pusher 11 and the outer cylinder 12, the medical device 100 is not limited to this. In addition to the above, as shown in FIG. 6, the syringe body 10a of the medical device 100a is provided with a plurality of engaging portions 11b such as a plurality of convex portions in the longitudinal direction on the outer surface of the pusher 11a, and the inner surface of the outer cylinder 12a. May be provided with a plurality of engaged portions 12b that engage with the plurality of engaging portions 11b.
　複数の係合部１１ｂは、複数の被係合部１２ｂと共に、外筒１２ａに対して蒸留水１５を押し出す移動量を段階的に規制するストッパーのように機能する。複数の被係合部１２ｂは、内腔１４を設けた外筒１２ａの内側に設けられる。上記のように蒸留水１５は、腰部の皮内において穿刺箇所Ｐ１～Ｐ４に注入される。仮に、一箇所につき医療器具を１つ使用すれば、穿刺箇所Ｐ１～Ｐ４に穿刺するためには医療器具が４本必要になる。 The plurality of engaging portions 11b, together with the plurality of engaged portions 12b, function as stoppers that stepwise regulate the amount of movement of pushing the distilled water 15 toward the outer cylinder 12a. The plurality of engaged portions 12b are provided inside the outer cylinder 12a having the inner cavity 14. As described above, the distilled water 15 is injected into the puncture points P1 to P4 in the skin of the waist. If one medical device is used at one place, four medical devices are needed to puncture the puncture points P1 to P4.
　これについて、複数の係合部１１ｂと複数の被係合部１２ｂを用いて押し子１１ａを移動させれば、押し子１１ａを注射針２７に向けて移動させても係合部１１ｂが１つ隣り合う被係合部１２ｂと係合して移動が一旦停止する。医師等の医療器具１００ａの使用者は、係合部１１ｂが隣接する被係合部１２ｂと係合したことを手の感覚（触覚）によって認識（認知）できる。 In this regard, if the pusher 11a is moved by using the plurality of engaging portions 11b and the plurality of engaged portions 12b, even if the pusher 11a is moved toward the injection needle 27, one engaging portion 11b is obtained. The movement is temporarily stopped by engaging with the adjacent engaged portions 12b. The user of the medical device 100a, such as a doctor, can recognize (recognize) that the engaging portion 11b is engaged with the adjacent engaged portion 12b by the sense (tactile sense) of the hand.
　これにより、一本の医療器具にて複数の穿刺箇所に蒸留水１５を注入できる。そのため、穿刺箇所Ｐ１～Ｐ４への蒸留水注入に必要な医療器具を減らし、保管スペースや廃棄物を削減することができる。また、一本の医療器具により、複数の穿刺箇所へ連続投与することができ、これにより手技の時間短縮等も期待できる。 With this, distilled water 15 can be injected into multiple puncture sites with one medical device. Therefore, it is possible to reduce the number of medical instruments required for injecting distilled water into the puncture points P1 to P4, and reduce the storage space and waste. Further, it is possible to continuously administer to a plurality of puncture sites with a single medical device, which can be expected to shorten the time of the procedure.
　なお、図６ではテーパー形状を備えた係合部１１ｂと被係合部１２ｂを３つ設けている。ただし、隣接する被係合部と係合することによって係合部の注射針に向けての移動量が規制できれば、係合部及び被係合部の形状や数は図６に限定されない。 Incidentally, in FIG. 6, three engaging portions 11b and engaged portions 12b each having a tapered shape are provided. However, the shapes and numbers of the engaging portions and the engaged portions are not limited to those shown in FIG. 6 as long as the amount of movement of the engaging portions toward the injection needle can be regulated by engaging with the adjacent engaged portions.
　本出願は、２０１８年１１月６日に出願された日本国特許出願第２０１８－２０９２３９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. 2018-209239 filed on Nov. 6, 2018, the disclosure content of which is incorporated by reference in its entirety.
１００、１００ａ　医療器具、
１０　シリンジ本体、
１１、１１ａ　押し子、
１１ｂ　係合部、
１２、１２ａ　外筒、
１２ｂ　被係合部、
１４　内腔、
１５　蒸留水（液体）、
２０　注射針組立体、
２７　注射針（穿刺部）、
３２　皮内、
Ｐ１～Ｐ４　穿刺箇所。 100, 100a medical equipment,
10 Syringe body,
11, 11a pusher,
11b engaging part,
12, 12a outer cylinder,
12b Engagement part,
14 lumen,
15 distilled water (liquid),
20 needle assembly,
27 injection needle (puncture part),
32 intradermal,
P1 to P4 puncture site.

Claims (5)

  1. 　内腔と穿刺部とを備え、前記内腔に液体が予め充填された医療器具の前記穿刺部を用いて分娩中の妊婦の腰部における皮内に穿刺箇所を形成し、
    　前記内腔から前記穿刺箇所に前記液体を注入することによって、子宮収縮により刺激される神経よりも伝導速度の速い神経に刺激を付与する疼痛軽減方法。     An inner cavity and a puncture portion are formed, and a puncture point is formed in the skin in the lumbar region of a pregnant woman during delivery using the puncture portion of a medical device in which the inner cavity is preliminarily filled with liquid.
    A method for reducing pain, which comprises injecting the liquid from the lumen into the puncture site to give stimulation to a nerve having a faster conduction velocity than the nerve stimulated by uterine contraction.
  2. 　前記液体は、滅菌された蒸留水を含む請求項１に記載の疼痛軽減方法。 The pain reducing method according to claim 1, wherein the liquid contains sterilized distilled water.
  3. 　内腔と穿刺部とを備え、前記内腔に液体が予め充填された医療器具の前記穿刺部を用いて分娩中の妊婦の腰部における皮内に穿刺箇所を形成し、
    　前記内腔から前記穿刺箇所に前記液体を注入することによって、子宮収縮により刺激される神経よりも伝導速度の速い神経に刺激を付与する疼痛軽減方法に用いられる液体。     An inner cavity and a puncture portion are formed, and a puncture point is formed in the skin in the lumbar region of a pregnant woman during delivery using the puncture portion of a medical device in which the inner cavity is preliminarily filled with liquid.
    A liquid used for a pain relieving method of injecting the liquid from the lumen into the puncture site to give stimulation to a nerve having a faster conduction velocity than the nerve stimulated by uterine contraction.
  4. 　内腔と穿刺部とを備え、前記内腔に液体が予め充填された医療器具の前記穿刺部を用いて分娩中の妊婦の腰部における皮内に穿刺箇所を形成し、
    　前記内腔から前記穿刺箇所に前記液体を注入することによって、子宮収縮により刺激される神経よりも伝導速度の速い神経に刺激を付与する疼痛軽減方法において、前記内腔に前記液体が予め充填された医療器具。     An inner cavity and a puncture portion are formed, and a puncture point is formed in the skin in the lumbar region of a pregnant woman during delivery using the puncture portion of a medical device in which the inner cavity is preliminarily filled with liquid.
    By injecting the liquid from the lumen to the puncture site, a method of reducing pain in which stimulation is applied to a nerve having a faster conduction velocity than the nerve stimulated by uterine contraction, the lumen is pre-filled with the liquid. Medical equipment.
  5. 　前記内腔に充填された前記液体を前記穿刺部に向けて押出す押し子と、
    　前記内腔を設けた外筒と、をさらに備え、
    　前記押し子は、前記外筒に対して前記液体を押出す移動量を段階的に規制する複数の係合部を備え、
    　前記外筒は、前記内腔を設けた内側に設けられ、前記複数の係合部と係合する被係合部を備える請求項４に記載の医療器具。     A pusher that pushes the liquid filled in the lumen toward the puncture portion,
    And an outer cylinder provided with the inner cavity,
    The pusher includes a plurality of engaging portions that regulate a moving amount for pushing the liquid with respect to the outer cylinder in a stepwise manner,
    The medical instrument according to claim 4, wherein the outer cylinder includes an engaged portion that is provided inside the inner cavity and that engages with the plurality of engaging portions.
PCT/JP2019/030565 2018-11-06 2019-08-02 Method for reducing pain, liquid and medical instrument WO2020095496A1 (en)

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Citations (2)

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JPS60138542U (en) * 1984-02-28 1985-09-13 三菱鉛筆株式会社 syringe
JP2009028527A (en) * 2007-06-28 2009-02-12 Tokai Univ Syringe

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Publication number Priority date Publication date Assignee Title
JPS60138542U (en) * 1984-02-28 1985-09-13 三菱鉛筆株式会社 syringe
JP2009028527A (en) * 2007-06-28 2009-02-12 Tokai Univ Syringe

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Title
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