JP2022016725A - Pain relief method, liquid, and medical device - Google Patents

Abstract

To provide a pain relief method capable of relieving pain during childbirth without relying on epidural anesthesia.SOLUTION: A pain relief method according to the invention uses a medical device 100 having a lumen 14 previously filled with sterilized distilled water 15 and an injection needle 27 to form puncture points P1 to P4 in the skin of the waist of a pregnant woman during delivery, and inject the sterilized distilled water into the puncture points from the lumen of the medical device through the injection needle 27 thereof to stimulate a nerve with a faster conduction velocity than a nerve stimulated by uterine contraction.SELECTED DRAWING: Figure 3

Description

The present invention relates to pain relief methods, liquids and medical devices.

Pregnant women experience a great deal of pain during childbirth due to natural childbirth, and much research has been done on how to relieve that pain. In general spontaneous delivery, labor begins at the time of delivery, and this labor is often perceived as strong low back pain. Such low back pain is caused by contraction of the uterus, unlike so-called general low back pain. This back pain may make it difficult for pregnant women to stand up, which is a major cause of physical exhaustion in pregnant women.

Aromatherapy and massage are available as methods for reducing such pain during labor, but their effects are ambiguous. In addition, painless delivery includes local anesthesia by pudendal nerve block or epidural anesthesia or general anesthesia by intravenous infusion. Generally, epidural anesthesia is performed, and when epidural anesthesia cannot be performed, intravenous infusion is performed. Will be implemented. As a technique relating to epidural anesthesia, Patent Document 1 discloses a technique for administering a composition containing a bicarbonate, a nitrate, a phosphate or the like when performing epidural anesthesia.

Special Table 2017-508004

The merits of the method using epidural anesthesia as in Patent Document 1 are that the pain-relieving effect is high, the mother's consciousness is clear, the anesthetic does not affect the fetus, and the caesarean section can be performed as it is. .. However, the disadvantage of epidural anesthesia may be serious complications such as anesthesia poisoning. Therefore, medical institutions that perform epidural anesthesia need the presence of experienced anesthesiologists and other doctors and a facility system that can respond to emergencies. However, the number of anesthesiologists is insufficient in Japan, and it is not always possible for an experienced anesthesiologist to be in charge of all pregnant women.

Therefore, an object of the present invention is to provide a pain reducing method capable of reducing lower back pain during childbirth without using epidural anesthesia.

The pain-relieving method according to the present invention, which achieves the above object, has a lumen and a puncture portion, and the skin in the lumbar region of a pregnant woman during delivery using the puncture portion of a medical device in which the lumen is prefilled with liquid. A puncture site is formed inside. Then, by injecting the liquid from the lumen into the puncture site, the nerve having a faster conduction rate than the nerve stimulated by the uterine contraction is stimulated. Further, the present invention is a liquid used in the above-mentioned pain relief method. Further, the present invention is a medical device in which the lumen is pre-filled with a liquid.

According to the pain-relieving method, the liquid used in the pain-relieving method, and the medical device 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 epidural anesthesia. It is possible to reduce the pain in the lower back of a pregnant woman at the time of delivery.

It is a front view which shows disassembled the medical device used for the pain relief method which concerns on one Embodiment of this invention. It is an enlarged view which shows the tip of the puncture part in the medical device shown in FIG. It is a partial cross-sectional view of the medical device shown in FIG. It is a figure in the vicinity of the lumbar region which shows the puncture point of the human body punctured by the medical device shown in FIG. 1. It is a flowchart which shows the pain relief method which concerns on one Embodiment of this invention. It is a partial cross-sectional view which shows the modification of the syringe body in FIG.

Hereinafter, embodiments of the present invention will be described with reference to the attached drawings. FIG. 1 is a front view showing the medical device 100 used in the pain reduction method according to the embodiment of the present invention in an exploded manner. FIG. 2 is an enlarged view showing the tip of the puncture portion 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 low back pain in a pregnant woman who gives birth by natural childbirth or the like. First, in explaining the pain reduction method, the medical device 100 used in the pain reduction method according to the present embodiment will be described.

(Medical equipment)
The medical device 100 has a syringe body 10 and an injection needle assembly 20 as shown in FIG.

As shown in FIG. 1, the syringe 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 out the liquid filled in the lumen 14 toward the injection needle 27 described later. The lumen 14 is configured to be provided inside the outer cylinder 12. The pusher 11 is configured to be insertable into the lumen 14 of the outer cylinder 12. A gasket 13 formed of rubber or the like is attached to the tip of the pusher 11, and the pusher 11 is configured to be insertable into the lumen 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. The lumen 14 of the outer cylinder 12 is configured so that the sterilized distilled water 15 is preliminarily liquid-tightly sealed before use. The sterilized distilled water 15 corresponds to the liquid injected (administered) into the skin in the waist of a pregnant woman in the present specification. As used herein, the term "liquid" means an epidural anesthesia that can be administered to a pregnant woman at the time of delivery without being an anesthesiologist.

The distilled water 15 sterilized in the present embodiment is not particularly limited as long as the distilled water is sterilized. Can be mentioned. The cylinder tip 17 extends from the outer cylinder 12, and as shown in FIG. 3, a lumen 14 having a diameter smaller than that of the proximal end side is provided inside.

As shown in FIG. 3, the lock mechanism 16 is configured by a female screw that can be screwed with the cap 18 in the present embodiment. A male screw is provided on the cap 18, and the male screw of the cap 18 and the female screw related to the lock mechanism 16 are screwed so that the distilled water 15 contained in the lumen 14 is sealed.
As shown in FIG. 1, the injection needle assembly 20 includes an engaging cylinder 22, an elastic body 23, a needle hub 24, a stabilizing portion 26, and an injection needle 27 (corresponding to a puncture portion). As shown in FIG. 3, the engaging cylinder 22 is provided with a male screw that can be screwed with the female screw related to 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 the gap provided between the cylinder tip 17 and the needle hub 24 by engaging the lock mechanism 16 and the engaging cylinder 22. The injection needle 27 is provided with a needle hole that communicates from the needle tip to the needle base end, and is provided with a needle tube having a blade surface at the needle tip. The injection needle 27 is configured to protrude from the adjusting portion 25 of the needle hub 24. The stabilizing portion 26 is formed in a hollow tubular 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.

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, and is 26 to 25 gauge. It is configured to be (corresponding to a diameter of 0.45 to 0.15 mm).

As shown in FIG. 1, the injection needle assembly 20 is surrounded by a packaging container 21b and a packaging lid 21a integrally configured until just before use, and can be taken out by peeling the packaging lid 21a from the packaging container 21b and separating it. It is composed.

The material of the member constituting the medical device 100 is not particularly limited, but is as follows, for example. The outer cylinder 12, the locking mechanism 16, the cylinder tip 17, the engaging cylinder 22, the needle hub 24, the adjusting portion 25, and the stabilizing portion 26 can be made of polyprelopylene, 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 and styrene, or a mixture thereof. The injection needle 27 can be made of stainless steel, aluminum, aluminum alloy, titanium, titanium alloy or other metal.

(Pain reduction method)
Next, the pain reduction method according to the present embodiment will be described. FIG. 4 is a (back) view of the vicinity of the lumbar region showing the puncture site of the human body punctured by the medical device 100 shown in FIG. FIG. 5 is a flowchart showing a pain reduction method according to an embodiment of the present invention.

First, a medical device 100 in which the lumen 14 is pre-filled with 0.1 ml of sterilized distilled water 15 is prepared. Next, the pregnant woman lies on a known delivery table (not shown) in a supine position (ST1) under the direction of a doctor or midwife. Then, the posture is temporarily changed so that the vicinity of the lumbar region, which is the puncture points P1 to P4, faces the doctor even in the back.

Next, the doctor peels off the packaging lid 21a from the packaging container 21b to separate it, and takes out the injection needle assembly 20 from the packaging container 21b. Then, the cap 18 of the syringe body 10 is removed from the cylinder tip 17, and the male screw of the engaging cylinder 22 of the injection needle assembly 20 and the female screw of the lock mechanism 16 are screwed into the cylinder tip 17. As a result, 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 completely filled by the elastic deformation of the elastic body 23, and the liquid-tight state is established.

Next, as shown in FIG. 4, the doctor points the needle tip of the injection needle 27 of the injection needle assembly 20 toward the puncture points P1 to P4 near the waist, which is the puncture site. Next, the doctor put about 0.1 ml of distilled water 15 sterilized using the medical device 100 in a state facing the vicinity of the waist 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 (puncture in FIG. 4). Intradermal administration (injection) to sites P1 to P4) (ST2).

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 portion 26 presses the skin epidermis 33 of the skin 30 and the adjusting portion 25 contacts the skin epidermis 33. As a result, the surface of the skin epidermis 33 is pulled by the adjusting portion 25 and the stabilizing portion 26, and the needle hub 24 provides medical treatment. The instrument 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 on the blade surface is just 1 to 4 mm from the surface of the skin epidermis 33 among the intradermal 32 in the upper layer of the skin. It reaches the shallow intradermal target site, but does not reach the subcutaneous tissue 31. In this state, the pusher 11 is pushed all the way out and sterilized distilled water 15 is injected. As a result, the sterilized distilled water 15 reaches the inside of the skin 32, which is 1 to 4 mm deep from the surface of the skin epidermis 33.

After the administration of the distilled water 15, the pregnant woman is in the supine position on the delivery table, and the left and right thighs and lower legs are opened so as to be separated from each other and placed on the footrest of the delivery table. Then, according to the instructions of the doctor or midwife, the fetus is delivered from the uterine ostium while changing the position such as raising the upper body, breathing, and taking a deep breath (ST3).

In this method, after the distilled water 15 is administered to the intracutaneous 32 of the puncture points P1 to P4 of the lumbar region, a temporary pain is felt at the administration site, but the pain disappears in about 30 seconds to several minutes. , Exhibits a pain-relieving effect. The pain-relieving method according to the present embodiment is expected to have a faster pain-relieving effect than the method using epidural anesthesia.

In addition, the pain-relieving method according to the present embodiment can be expected to have a significant pain-relieving effect as compared with no treatment or massage. The duration of pain relief is up to about 2 hours, 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, uterine contractions in labor during childbirth are visceral pain sensations and are mediated by C nerve fibers. C nerve fibers are relatively thin unmyelinated nerves and have a slow conduction rate. On the other hand, the visceral pain sensation is suppressed by stimulating Aβ nerve fibers (tactile / pressure sensation) and Aδ nerve fibers (somatic pain sensation), which are thicker and faster conduction nerve fibers (myelinated nerves). This alleviates the pain caused by uterine contractions, which is a visceral pain sensation.

In order to obtain a pain-relieving (pain-relieving) effect, it is necessary to stimulate nerves existing in the skin. Such nerves are more distributed in the skin (mainly the dermis layer) than in the subcutaneous tissue. In addition, such irritation is brought about by the dose of the drug (physical skin compression), osmotic pressure (pain), temperature (cold, hot) and the like.

According to this method, pregnant women can also live. According to the pain reducing method according to the present invention, the consciousness of the pregnant woman is not affected and the behavior is not restricted. Therefore, it is possible to prevent the progress of delivery 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 at the time of administration. Furthermore, treatment is possible even if the doctor does not have specialized knowledge, such as epidural anesthesia.

In addition, this method is safe for mothers and children, and at least has no side effects on children. Furthermore, this method does not require anesthesia such as epidural anesthesia, and the cost required for the procedure can be reduced. In addition, the pain-relieving method according to the present embodiment can be used in combination with other pain-relieving methods such as Lamaze method, massage, and aromatherapy.

As described above, the pain relief method according to the present embodiment is provided with a cavity 14 and an injection needle 27, and delivery is performed using an injection needle 27 of a medical device 100 in which the lumen 14 is prefilled with distilled water 15. Puncture points P1 to P4 are formed on the waist of the pregnant woman inside. Then, sterilized distilled water 15 is injected (administered) from the lumen 14 of the medical device 100 into the skins of the puncture points P1 to P4. This stimulates nerves that have a faster conduction rate than nerves that are stimulated by uterine contractions.

Epidural anesthesia is another method for reducing pain caused by uterine contractions in pregnant women during childbirth. It is said that epidural anesthesia has a high pain-relieving effect, the mother's consciousness is clear, the anesthesia does not affect the fetus, and a caesarean section can be performed as it is. However, epidural anesthesia becomes difficult to breathe, and in some cases, fever and hypotension occur, causing serious complications such as anesthetic poisoning, and in the worst case, death may occur.

Therefore, in order to carry out epidural anesthesia, strict control of anesthetics is required, an anesthesiologist with specialized knowledge is required, and a facility system capable of responding to emergencies is also required. As mentioned above, it is hard to say that there are enough anesthesiologists in Japan, and it is hard to say that the cost burden for couples associated with epidural anesthesia is light.

On the other hand, in the pain reduction method according to the present embodiment, the puncture site P1 to the waist of the pregnant woman
The procedure can be carried out more easily than epidural anesthesia, because the distilled water 15 formed by forming 4 and sterilized is administered. In addition, the pain-relieving effect of this method appears in about 30 seconds after administration, lasts for up to about 2 hours, and repeated administration of distilled water is possible.

Furthermore, no anesthesiologist is required, and it can be used in combination with other pain-relieving methods such as Lamaze method, massage, and aromatherapy. In addition, according to this method, it is possible to deliver spontaneously without affecting the consciousness of the pregnant woman after administration, without restricting the behavior, and not to affect the progress of the subsequent delivery. can.

In addition, in this method, pain due to uterine contraction during childbirth can be reduced by forming puncture points P1 to P4 in the intracutaneous 32 of the waist of a pregnant woman.

Further, the lumen 14 of the medical device 100 is configured to be pre-filled with sterilized distilled water 15 before use. Therefore, the time required for the work of filling the lumen 14 with the distilled water 15 and the filling work during the procedure becomes unnecessary. Therefore, it is possible to improve the workability of workers such as doctors and promptly reduce the pain of pregnant women caused during childbirth.

Further, according to the pain reducing method according to the present embodiment, 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 sterilized distilled water, this implementation is carried out even at medical institutions that do not have specialized knowledge or experienced anesthesiologists compared to epidural anesthesia. A morphologically pain-relieving method can be implemented. In addition, since the sterilized distilled water 15 is cheaper than the anesthesia used for epidural anesthesia, it can also contribute to reducing the financial burden on pregnant women who desire to reduce the pain associated with uterine contractions during childbirth. ..

Further, according to this method, by using sterilized distilled water 15 for the medical device, it is possible to reduce pain in a pregnant woman due to uterine contraction during childbirth.

Further, according to the present embodiment, by using the medical device 100 in which the lumen 14 is filled with distilled water 15 sterilized in advance, it is possible to reduce the pain in the lower back that occurs in a pregnant woman during childbirth.

The present invention is not limited to the above-described embodiment, and various modifications can be made within the scope of the claims. In the above, the embodiment for reducing the pain of a pregnant woman in natural childbirth has been described, but the present invention is not limited thereto. In addition to the above, if epidural anesthesia is not used, a labor-promoting agent or the like may be administered to the pregnant woman.

Further, when the distilled water 15 is injected into the puncture sites P1 to P4, the pregnant woman temporarily feels some pain when the distilled water 15 is injected due to the difference between the living body and the osmotic pressure. Therefore, instead of the distilled water 15, physiological saline or the like may be added to the sterilized distilled water. As a result, it can be expected that the above-mentioned pain-relieving (pain-relieving) effect is maintained while reducing the stimulation by osmotic pressure. Further, the liquid to be injected into the puncture points P1 to P4 in the lumbar region of the 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 in FIG. 1. Although it has been described above that the medical device 100 has a syringe body 10 including a pusher 11 and an outer cylinder 12, the present invention 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 is provided. May be provided with a plurality of engaged portions 12b that engage with the plurality of engaging portions 11b.

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 the distilled water 15 with respect to the outer cylinder 12a. The plurality of engaged portions 12b are provided inside the outer cylinder 12a provided with the lumen 14. As described above, the distilled water 15 is injected into the puncture points P1 to P4 in the skin of the lumbar region. If one medical device is used for each site, four medical devices are required to puncture the puncture points P1 to P4.

Regarding this, 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 provided. The movement is temporarily stopped by engaging with the adjacent engaged portions 12b. A 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 of the hand (tactile sense).

This makes it possible to inject distilled water 15 into a plurality of puncture points with a single medical device. Therefore, it is possible to reduce the number of medical devices required for injecting distilled water into the puncture points P1 to P4, and reduce the storage space and waste. In addition, one medical device can be used for continuous administration to a plurality of puncture sites, which can be expected to shorten the procedure time.

In FIG. 6, three engaging portions 11b and three engaged portions 12b having a tapered shape are provided. However, the shape and number of the engaged portion and the engaged portion are not limited to FIG. 6 as long as the amount of movement of the engaged portion toward the injection needle can be regulated by engaging with the adjacent engaged portion.

100, 100a medical equipment,
10 Syringe body,
11, 11a pusher,
11b engaging part,
12, 12a outer cylinder,
12b engaged part,
14 lumen,
15 Distilled water (liquid),
20 needle assembly,
27 Injection needle (puncture site),
32 In the skin,
P1 to P4 puncture points.

Claims (5)

Using the puncture portion of a medical device having a lumen and a puncture portion in which the lumen is prefilled with liquid, a puncture site is formed in the skin of the lumbar region of a pregnant woman during delivery.
A pain-relieving method for injecting the liquid from the lumen into the puncture site to stimulate a nerve having a faster conduction rate than a nerve stimulated by uterine contraction. The pain-relieving method according to claim 1, wherein the liquid contains sterilized distilled water. The liquid used for the pain relief method according to claim 1 or 2. The medical device in which the liquid is pre-filled in the lumen according to any one of claims 1 to 3. A pusher that pushes the liquid filled in the lumen toward the puncture site,
Further provided with an outer cylinder provided with the lumen,
The pusher comprises a plurality of engaging portions that stepwise regulate the amount of movement of the liquid to be pushed out to the outer cylinder.
The medical device according to claim 4, wherein the outer cylinder is provided inside the lumen and is provided with an engaged portion that engages with the plurality of engaging portions.

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