WO2021224961A1 - Medical instrument for rupturing membranes - Google Patents

Abstract

Provided is a medical instrument for rupturing membranes which enables fetal membranes to be ruptured safely in an amniotomy. The medical instrument (100) for rupturing membranes comprises: a first finger covering part (10) for covering the first finger; and a first membrane rupturing part (11) which includes a file-like portion provided on the first finger covering part (10).

Description

Medical device for rupture

The present invention relates to a medical device for breaking the fetal membrane during childbirth.

Conventionally, artificial rupture of the membrane has been performed to artificially perforate and rupture the amniotic fluid in order to induce and promote labor pain. Such artificial rupture of the uterus is generally performed by inserting Kochel or Pean forceps by guiding the internal examination fingers (mainly the index finger and middle finger) inserted into the cervix and perforating the fetal membrane at the uterine ostium. ..

Further, as a medical device used for artificial rupture of the membrane, the one described in Patent Document 1 is known. That is, Patent Document 1 describes a finger cot comprising "a finger cot made of a hard material and a claw or hook-shaped curved element attached to one finger of a glove". A surgical instrument that is glove-like and intended to be placed in the vagina during delivery to rupture the fetal membrane, the fetal membrane, is disclosed.

Japanese Unexamined Patent Publication No. 60-210249

By the way, in conventional artificial rupture surgery, there is a risk that forceps or the like inserted into the cervical canal may damage these parts when they directly touch the uterine ostium, the inside of the cervical canal, or the head of the foetation. .. Further, the surgical instrument described in Patent Document 1 also has the same problem, and since the curved element protrudes from the fingertip, the curved element provided on the fingertip is generated when the finger is inserted into and removed from the cervical canal. There is still a risk of getting caught in the cervix, inside the cervix, or on the fetal head and damaging these areas.

Therefore, the main object of the present invention is to provide a medical device capable of safely rupturing the fetal membrane in artificial rupture of the membrane.

The present invention relates to a medical device for fetal membrane rupture. The medical instrument for rupture of a membrane according to the present invention is for a first rupture of a membrane including a first finger covering portion for covering the first finger and a file-shaped portion provided on the first finger covering portion. Has a part. The medical device for membrane rupture according to the present invention may be a glove type or a finger cot type. An example of the first finger is the index or middle finger. In addition, the membrane rupture part is file-shaped and has a physical structure that can be ruptured by cutting the fetal membrane. By providing such a file-shaped rupture membrane portion in the finger covering portion, it is possible to prevent the rupture membrane portion from injuring the body of a pregnant woman or the head of a foetation when inserting and removing a medical device into the cervix. .. In particular, the file-shaped rupture film portion is formed on the surface of the finger covering portion and does not protrude from the fingertip or the like. Therefore, the medical device of the present invention can be more safely inserted into the cervix as compared with the surgical device described in Patent Document 1 provided with a curved element protruding from the fingertip.

In one embodiment of the membrane rupture medical device according to the present invention, the first membrane rupture portion is provided on the side surface of the first finger covering portion. In this way, by providing the membrane rupture part on the side surface of the finger instead of the fingertip of the finger covering part, the medical device can be safely inserted and removed from the cervical canal.

In the medical device for membrane rupture according to the present invention, the tip portion of the first finger is A, the portion closest to the tip portion of the first membrane rupture portion is B, and the longitudinal direction of the first finger is the X-axis. The position of B on the X-axis is preferably 2 mm or more and 3 cm or less away from the position of A. In this way, by providing the membrane rupture site at a position separated from the fingertip by a certain distance, it is possible to more effectively prevent the membrane rupture site from injuring the body of the pregnant woman or the head of the foetation.

The medical device for membrane rupture according to the present invention may be in the shape of a glove. In this case, the medical device for membrane rupture has a second finger covering portion for covering the second finger adjacent to the first finger and a file-shaped portion provided on the side surface of the second finger covering portion. It is preferable to further have a second membrane rupture portion containing the above. Further, it is preferable that the first membrane rupture portion and the second finger covering portion are provided at positions facing each other. In this way, by providing a file-shaped membrane rupture part at the opposite positions of the first finger covering part (for example, the part covering the index finger) and the second finger covering part (for example, the part covering the middle finger). The membrane can be ruptured by sandwiching the fetal membrane between the two membrane rupture portions. Therefore, it is possible to more reliably perform the rupture work of the fetal membrane.

In another embodiment of the membranous medical device according to the present invention, the first membranous portion extends from the finger pad side of the first finger covering portion beyond the fingertip to the finger dorsal side. May be. In this way, by providing the membrane rupture portion extending on the finger pad side and the finger dorsal side with the fingertip as the center, it becomes easy to perform the procedure of rupturing the fetal membrane by hooking it on the fingertip.

In the membrane rupture medical device according to the present invention, the first membrane rupture portion may be attached to the first finger covering portion as a retrofit. In this way, the existing medical glove (glove) can be used to construct the medical device for membrane rupture according to the present invention.

According to the present invention, it is possible to provide a medical device capable of safely rupturing the fetal membrane in artificial rupture of the membrane.

FIG. 1 schematically shows a glove-type medical device for membrane rupture according to the first embodiment. FIG. 2 schematically shows an example of using the medical device for membrane rupture according to the first embodiment. FIG. 3 schematically shows a finger cot type medical device for membrane rupture according to the second embodiment. FIG. 4 schematically shows a finger cot type medical device for membrane rupture according to the third embodiment.

Hereinafter, a mode for carrying out the present invention will be described with reference to the drawings. The present invention is not limited to the forms described below, and includes those which are appropriately modified by those skilled in the art from the following forms to the extent obvious to those skilled in the art.

FIG. 1 shows a glove-type medical device for membrane rupture 100 according to the first embodiment of the present invention. The entire membrane rupture medical device 100 is made of a flexible material such as natural rubber, synthetic rubber such as chloroprene, or plastic such as nylon, polyethylene, vinyl chloride, vinyl acetate, etc., and is inserted. It is configured to be in close contact with the fingers. Further, as shown in FIG. 1, the glove-type rupture membrane medical device 100 includes an index finger covering portion 10 that covers the index finger, a middle finger covering portion 20 that covers the middle finger, a thumb covering portion 30 that covers the thumb, and a ring finger coating that covers the ring finger. The part 40, the little finger covering part 50 covering the little finger, the palm covering part 60 covering the palm and the back, and the wrist covering part 70 covering the wrist are included, and these parts are integrally connected to form a glove shape. ing. In the example shown in FIG. 1, the medical device 100 for membrane rupture is a glove type for the right hand, but may be a glove type for the left hand.

In the glove-type medical device 100 for membrane rupture, an egg membrane is provided on the side surface of at least one of the index finger covering portion 10, the middle finger covering portion 20, the thumb covering portion 30, the ring finger covering portion 40, and the little finger covering portion 50. A membrane rupture portion for rupturing the membrane is provided. In particular, among the index finger covering portion 10, the middle finger covering portion 20, the thumb covering portion 30, the ring finger covering portion 40, and the little finger covering portion 50, a membrane rupture portion is provided on each side surface of the pair of covering portions that cover adjacent fingers. Is preferable. In the example shown in FIG. 1, film breaking portions 11 and 21 are provided on the side surface of the index finger covering portion 10 and the side surface of the middle finger covering portion 20, respectively. As described above, it is particularly preferable to provide the membranous portion 11.21 on each of the index finger and the middle finger, which are the pelvic examination fingers inserted into the cervix. However, the one shown in the figure is an example. For example, the index finger covering portion 10 and the thumb covering portion 30 are provided with a membrane rupture portion, the middle finger covering portion 20 and the ring finger covering portion 40 are provided with a membrane rupture portion, or the ring finger. It is also possible to provide a film-breaking portion on the covering portion 40 and the little finger covering portion 50.

In the present embodiment, the film-breaking portions 11 and 21 provided on the side surfaces of the index finger covering portion 10 and the middle finger covering portion 20 have a file-shaped portion. The file shape means a shape in which a plurality of fine protruding or linear blades (eyes) are formed, and the fetal membrane is partially scraped by such a blade to rupture the membrane. The file-shaped membrane rupture portions 11 and 21 are not particularly limited as long as they have a shape capable of rupturing the fetal membrane. Intersecting compound (double or triple), shaving with more grooves for the compound, wavy with curved blades, or multiple protrusions without grooves It is possible to adopt a demon-like shape formed by. In addition, the cross-sectional shape of each blade may be a shape suitable for film rupture, such as a triangle, a square, or a rhombus. Since the membrane rupture portions 11 and 21 are used for the purpose of rupturing the fetal membrane, they are formed of other parts of the rupture medical device 100 or a material harder than the fetal membrane. The film-breaking portions 11 and 21 can be formed of, for example, a biocompatible metal material, a hard plastic material, or a hardened natural rubber or synthetic rubber. Further, the membrane rupture portions 11 and 21 can be attached to the finger covering portions 10 and 20 as a retrofit. In this case, the film-breaking portions 11 and 21 may be formed into a sheet shape, one surface may be formed into a file shape, and an adhesive layer or an adhesive layer may be provided on the other surface. For example, the sheet-shaped membrane-breaking medical device 100 according to the present invention may be formed by attaching the sheet-shaped membrane-breaking portions 11 and 21 to the existing medical gloves afterwards.

The method for forming a file-shaped rupture membrane portion is as follows. That is, the file material can be rolled, annealed, the surface of the material is polished, and then the file can be formed on the film-breaking portions 11 and 21 by a dressing machine or hand cutting. Alternatively, diamond abrasive grains or the like can be electrodeposited on the surface of the rolled material to form files on the film-breaking portions 11 and 21. As another method, a method of forming microneedles can be adopted. For example, a master mold having an acute-angled groove is produced by a lithography technique used for precision microfabrication or manufacturing a semiconductor device, and the master mold is used as a mold and pressed onto the base material of the film breaking portions 11 and 21 to be transferred. By rotating this mold by a predetermined angle and pressing it again, it is possible to form a polygonal pyramid-shaped spear on the film-breaking portions 11 and 21. Alternatively, using inkjet technology, highly viscous raw materials are adhered to the substrate as droplets at predetermined intervals, and the droplets are stretched to form substantially conical spirals on the film-breaking portions 11 and 21. Can be done. Alternatively, by irradiating the base material of the film breaking portions 11 and 21 with a circularly polarized light vortex laser beam, an ablation phenomenon is generated on the surface of the base material, and needle-shaped spicules are formed on the surface. be able to.

The film-breaking portions 11 and 21 formed on the covering portions of a pair of adjacent fingers are provided at positions facing each other. Specifically, the membrane-breaking portion 11 provided on the index finger covering portion 10 and the membrane-breaking portion 21 provided on the middle finger covering portion 20 are at least partially mutually formed when the wearer's finger is closed. It is provided at the contact position. That is, the membrane rupture portion 11 of the index finger covering portion 10 is provided on the side surface on the middle finger side, and the membrane rupture portion 21 of the middle finger finger covering portion 20 is provided on the side surface on the index finger side. In particular, the membrane-breaking portions 11 and 21 formed on the covering portions of a pair of adjacent fingers have an upper edge portion (edge on the fingertip side) and a lower edge portion (finger's edge) when the wearer's finger is closed. It is preferable that the edges on the root side are aligned. In this way, by providing the two membrane rupture portions 11 and 21 at positions facing each other, the fetal membrane is sandwiched between the two razor-shaped membrane rupture portions 11 and 21 with two finger fingers. By pinching the fetal membrane, it becomes possible to easily rupture the fetal membrane.

In FIG. 1, the longitudinal direction of a finger (for example, the index finger) provided with the membrane rupture portion 11 is shown on the X-axis. Further, the tip portion of the finger provided with the membrane rupture portion 11 is designated as A, and the portion closest to the tip portion of the membrane rupture portion 11 is designated as B. In this case, the distance d between the position B on the X-axis and the position A on the X-axis is preferably 2 mm to 3 cm, particularly preferably 5 mm to 2.5 cm or 1 cm to 2 cm. .. By providing the membrane rupture portion 11 at a position separated from the fingertip by a certain distance d in this way, when the membrane rupture medical device 100 is inserted into the cervix, the membrane rupture portion 11 can be placed inside the pregnant woman or in the pregnant woman. Damage to the head of the fetal can be suppressed more effectively. In FIG. 1, for the sake of simplicity, the distance d is shown only for the film-breaking portion 11 provided on the index finger covering portion 10, but the film-breaking portion 21 provided on the middle finger covering portion 20 is also shown. Similarly, it may be provided at a position separated from the fingertip by a distance d. It is preferable that the index finger rupture part 11 and the middle finger rupture part 21 adjust the value of the distance d so that the upper edge and the lower edge are aligned when the finger is closed. The distance d of the index finger rupture part 11 and the distance d of the middle finger rupture part 21 may be different values.

FIG. 2 schematically shows an example of using the glove-type medical device 100 for membrane rupture. As shown in FIG. 2, when artificial rupture of the membrane is performed at the time of delivery, the index finger and the middle finger provided with the rupture membrane portions 11 and 21 are placed on the cervix while the medical device for rupture membrane 100 is attached. It is inserted into the tube, and the fetal membrane is sandwiched between the two rupture parts 11 and 21, and the rupture parts 11 and 21 are rubbed against each other to rupture the membrane by scraping a part of the rupture membrane. .. As a result, for example, the fetal membrane can be ruptured without inserting Kochel or Pean forceps, so that it is possible to perform highly safe artificial rupture of the membrane for the mother and the foetation.

FIG. 3 shows finger cot type medical devices for rupture of the membrane 110, 120 according to the second embodiment of the present invention. As shown in FIG. 3, in the case of the finger cot type, for example, the rupture medical device 110 for the index finger and the rupture medical device 120 for the middle finger are separately manufactured. The index finger and middle finger may be sold separately or as a pair of two.

For the finger cot type medical devices 110 and 120 for rupture of the membrane, basically the same configuration and material as the above-mentioned glove type medical device for rupture of the membrane 100 can be adopted. That is, the finger cot type medical devices for rupture of the membrane 110 and 120 are provided with the rupture portions 111 and 112 on the side surface of the finger covering portion, respectively. The membrane rupture portions 111 and 112 have file-shaped portions, and are arranged at positions at a certain distance from their respective fingertips. Further, when the medical instrument 110 for rupture of the index finger and the medical instrument 120 for rupture of the middle finger are prepared, it is preferable that the rupture portions 111 and 112 are provided at positions facing each other. Other conditions can be the same as those of the glove type described above.

FIG. 4 shows a medical device for membrane rupture according to the third embodiment. The example shown in FIG. 4 is a finger cot type medical device 110 for rupture of the membrane for the index finger. FIG. 4A shows the dorsal side of the finger of the medical device 110 for rupture of the membrane, and FIG. 4B shows the ventral side of the finger of the same medical device for rupture of the membrane 110. In the embodiments shown in FIGS. 1 and 3, a file-shaped film-breaking portion is provided on the side surface of the finger covering portion. On the other hand, in the third embodiment shown in FIG. 4, the file-shaped membrane rupture portion 110 extends from the finger pad side of the membrane rupture medical instrument 110 (that is, the finger covering portion) to the finger back beyond the fingertip. It is arranged so as to reach the side. That is, one strip of membrane rupture portion 110 is formed over the finger pad, the fingertip, and the back of the finger. By arranging the file-shaped membrane rupture portion 100 in this way, the membrane can be ruptured by hooking the fetal membrane with a fingertip. Since the embodiment shown in FIG. 4 is used differently from the embodiment shown in FIGS. 1 and 3, it can be used properly according to the ability of the operator and the condition of the pregnant woman.

In the embodiment shown in FIG. 4, the width of the membrane rupture part 110 is preferably 0.5 to 2 cm or 0.8 to 1.5 cm, for example. Further, the length from the finger pad side end to the fingertip and the length from the finger dorsal end to the fingertip of the membrane rupture part 110 may be in the range from the wearer's fingertip to the first joint, respectively. preferable. Specifically, the length from the fingertip to each end is preferably 1 to 4 cm or 1.5 to 3 cm.

In the example shown in FIG. 4, the file-shaped membrane rupture portion 110 is not provided on the side surface of the membrane rupture medical device 110 (finger covering portion). That is, there are non-file-shaped portions on the left and right side surfaces of the medical device 110 for membrane rupture. By providing the non-file-shaped portion on the side surface of the membrane-breaking medical instrument 110 in this way, for example, when the membrane-breaking medical instrument is attached to the index finger and the middle finger, the file-shaped membrane-breaking portion 110 can be formed. It is possible to avoid a situation in which both fingers cannot be operated well due to mutual interference, or it becomes difficult to insert both fingers into the cervical canal. However, in another embodiment, the file-like rupture of the membrane is performed over the entire area of the finger pad, the side surface (finger side), and the back of the finger in the range from the fingertip to the first joint of the rupture membrane medical device 110. The portion 110 may be formed.

As described above, in the specification of the present application, in order to express the content of the present invention, the embodiments of the present invention have been described with reference to the drawings. However, the present invention is not limited to the above-described embodiment, and includes modifications and improvements which are obvious to those skilled in the art based on the matters described in the present specification.

The present invention relates to a medical device for breaking the fetal membrane during childbirth. Therefore, the present invention can be suitably used in the manufacturing industry of medical devices.

10 ... Index finger covering part 11 ... Membrane rupture part 20 ... Middle finger covering part 21 ... Membrane rupture part 30 ... Thumb covering part 40 ... Ring finger covering part 50 ... Little finger covering part 60 ... Palm covering part 70 ... Wrist covering part 100 ... Gloves Type medical device for rupture of the membrane 110 ... Finger cot type medical device for rupture of the membrane (for index finger)
120 ... Finger cot type medical device for membrane rupture (for middle finger)

Claims (6)

1. A first finger covering for covering the first finger, and
   A medical device for rupture of a membrane having a first portion for rupture of the membrane including a file-like portion provided on the first finger covering portion.
2. The medical device for membrane rupture according to claim 1.
   The first membrane rupture portion is a medical device for rupture of the membrane provided on the side surface of the first finger covering portion.
3. The medical device for membrane rupture according to claim 1 or 2.
   When the tip portion of the first finger is A, the portion of the first membrane rupture part closest to the tip portion is B, and the longitudinal direction of the first finger is the X axis, the X axis. The position of B on the top is 2 mm or more and 3 cm or less away from the position of A.
   Medical device for membrane rupture.
4. The medical device for membrane rupture according to claim 2.
   It is glove-shaped
   A second finger covering portion for covering the second finger adjacent to the first finger, and
   It further has a second membrane rupture portion including a file-like portion provided on the side surface of the second finger covering portion.
   The first membrane rupture portion and the second membrane rupture portion are medical devices for rupture of the membrane provided at positions facing each other.
5. The medical device for membrane rupture according to claim 1.
   The first membranous portion is a medical instrument for rupture of the membrane extending from the finger pad side of the first finger covering portion to the dorsal side of the finger beyond the fingertip.
6. The medical device for membrane rupture according to any one of claims 1 to 5.
   The first membrane-breaking portion is a medical device for membrane-breaking that is retrofitted to the first finger covering portion.

Images