Puncture device

Abstract

To provide a puncture device capable of stably puncturing an egg membrane to form a small hole in artificially breaking the membrane.SOLUTION: Provided is a puncture device 1 for performing transvaginal puncturing on an egg membrane VL. The puncture device 1 includes: a cup 2 that is a cap-shaped cylindrical body with an opening 22a in a proximal end, has a recess part 23 in a distal end portion 21, has a puncture needle 24 in an inner surface of the recess part 23, and has a suction hole 23a opened; and a suction tube 3 having one end connected with the suction hole 23a of the cup 2 and the other end connectable with suction means 5.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present disclosure relates to a puncturing device for transvaginally puncturing the amniotic membrane, and more particularly to a puncturing device that can be used while visually checking the condition with a transvaginal ultrasound probe. [Background technology]

[0002] In the medical field, artificial amniotomy, a procedure in which the amniotic membrane enveloping the fetus and amniotic fluid is blindly ruptured using fingers or forceps inserted transvaginally, has been used to induce labor in a planned manner in a pregnant woman experiencing protracted labor. Artificial amniotomy creates a small hole in the amniotic membrane, allowing local infection with intravaginal bacteria through the hole, which is expected to trigger cervical ripening and the onset of labor. Therefore, various surgical instruments for transvaginally rupturing the amniotic membrane have been proposed (e.g., Patent Documents 1 to 3).

[0003] Furthermore, in recent years, with the advent of techniques such as painless childbirth, a form of childbirth called planned childbirth, in which the timing of labor is artificially controlled, has become widespread, and as a result, the frequency of artificial amniotomy being used is on the rise. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Publication No. 48-62294 [Patent Document 2] Japanese Patent Application Publication No. 60-210249 [Patent Document 3] International Publication No. 2021 / 224961 Summary of the Invention [Problem to be solved by the invention]

[0005] However, adverse events associated with artificial amniotic rupture include fetal dysfunction due to the sudden loss of amniotic fluid caused by a defect in the amniotic membranes, and a particularly serious complication, umbilical cord prolapse, in which the umbilical cord prolapses and becomes trapped along with the amniotic fluid, causing permanent fetal ischemia. It has been pointed out that these adverse events may occur when artificial amniotic rupture is performed before labor progresses sufficiently and the fetus has yet to descend. Furthermore, with the spread of planned childbirth, there are concerns that these problems will increase.

[0006] The present disclosure has been made in consideration of the above-mentioned problems, and aims to provide a puncture device that can stably puncture a small hole in the fetal membrane during artificial membrane rupture. [Means for solving the problem]

[0007] In order to achieve the above object, a puncturing device according to one aspect of the present disclosure is a puncturing device for transvaginally puncturing the amniotic membrane, and is characterized by including a cap-shaped cylindrical body with an open base end, a cup having a recess at its tip end, a puncturing needle on the inner surface of the recess, and an air suction hole, and a suction tube having one end connected to the air suction hole of the cup and the other end configured to be connectable to suction means. [Effects of the Invention]

[0008] According to one aspect of the present disclosure, a puncturing device can be provided that can stably puncture a small hole in the fetal membrane during artificial membrane rupture, thereby suppressing the sudden outflow of amniotic fluid that occurs due to a defect in the fetal membrane during artificial membrane rupture. [Brief explanation of the drawings]

[0009] [Figure 1] 1A and 1B are schematic diagrams illustrating how the puncture device 1 according to the embodiment is used during surgery. [Figure 2] FIG. 1 is a perspective view showing the configuration of a lancing device 1. [Figure 3] 1 is a side cross-sectional view showing the configuration of a lancing device 1. FIG. [Figure 4]2 is an enlarged view of part A in FIG. 1, and is a side cross-sectional view illustrating the operating state of the part of the puncture device 1 that is inserted into the body during surgery. FIG. [Figure 5] 10(a) to 10(c) are photographs of a cup according to an embodiment of the lancing device 1. FIG. [Figure 6] 10(a) to 10(c) are photographs showing the results of an evaluation test of the lancing operation using an embodiment of the lancing device 1. [Figure 7] 10 is a photograph showing the results of an evaluation test of the lancing operation using an embodiment of the lancing device 1. DETAILED DESCRIPTION OF THE INVENTION

[0010] <<Outline of the mode for carrying out the present invention>> A puncturing device according to an embodiment of the present disclosure is a puncturing device for transvaginally puncturing the amniotic membrane, comprising: a cap-shaped cylindrical body with an open base end, a cup having a recessed portion at its tip end, a puncturing needle on the inner surface of the recessed portion, and an air suction hole; and a suction tube having one end connected to the air suction hole of the cup and the other end connectable to suction means. Furthermore, the puncturing device may be configured such that, with the tip end of the cup positioned transvaginally close to the amniotic membrane, the amniotic membrane can be sucked against the inner surface of the recessed portion, including the puncturing needle, by negative pressure generated by the suction means.

[0011] With this configuration, a puncture device can be provided that uses external negative pressure to slowly adsorb and suction the fetal membrane, enabling stable perforation of a small hole in the fetal membrane during artificial membrane rupture, thereby suppressing the sudden outflow of amniotic fluid that accompanies a defect in the fetal membrane during artificial membrane rupture.

[0012] In another aspect, in any of the above aspects, the cup may be a tubular soft member made of a flexible material that is permeable to ultrasound, and may be configured so that a transvaginal ultrasound probe can penetrate through the lumen of the tube to the back surface of the recessed portion.

[0013] With this configuration, the tip of the cup can be brought close to and into contact with the amniotic membrane while checking the amniotic membrane under ultrasound guidance, ensuring safety for the fetus.

[0014] In another aspect, in any of the above aspects, the puncture needle may be configured to be formed by embedding the base end of a needle-shaped metal or hard resin member into the inner surface of the recessed portion.

[0015] This configuration allows a small hole to be stably opened in the fetal membrane, preventing adverse events such as gross fetal membrane damage and maximum prolapse associated with fetal membrane damage.

[0016] In another aspect, in any of the above aspects, the suction tube may be configured so that the suction of amniotic fluid can be visually observed from outside the tube.

[0017] With this configuration, the success of the puncture can be confirmed externally by observing the state in which the amniotic fluid is being aspirated.

[0018] In another aspect, in any of the above aspects, a sleeve made of an elastic member may be configured to extend a predetermined length from the base end of the cup.

[0019] This configuration allows the sleeve to function as a transvaginal probe cover.

[0020] <Embodiment> The puncture device 1 according to the present embodiment will be described with reference to the drawings. Note that the drawings are schematic diagrams and may differ in scale from the actual one. Furthermore, the following description is an example for explaining the configuration, operation, and effect of one embodiment of the present disclosure, and the essential parts of the present disclosure are not limited to the following embodiment. Furthermore, in this specification and claims, including the following description, up and down indicate relative positional relationships, with the upward direction on the paper in the drawings being the "up" direction and the downward direction on the paper being the "down" direction. Furthermore, the distal end direction along the tube axis (insertion) direction of the puncture device 1 is the "forward" direction, and the proximal end direction is the "rear" direction. However, this does not necessarily correspond to an absolute (vertical) positional relationship between up and down. Furthermore, in this specification and claims, the symbol "~" used to indicate a numerical range includes both ends of the range.

[0021] <Overall configuration of lancing device 1> The puncture device 1 (hereinafter referred to as "Device 1") is a medical instrument used by doctors to transvaginally puncture the amniotic membranes of pregnant women experiencing prolonged labor in order to perform a procedure called artificial amniotomy, in which doctors break the amniotic membranes and initiate planned labor. Artificial amniotomy involves creating a small hole in the amniotic membrane, allowing local infection with vaginal bacteria to occur through the hole, with the hope that the infection will trigger cervical ripening and the onset of labor.

[0022] FIG. 1 is a schematic diagram illustrating a state in which a puncture device 1 according to an embodiment is used during surgery. As shown in Figure 1, within the body of a pregnant woman PR, a fetus FT resides in the uterus UT, filled with amniotic fluid AF and surrounded by a fetal membrane VL. To artificially rupture membranes in a pregnant woman PR using device 1, the physician places cup 2 of device 1 over a transvaginal ultrasound probe 4 through sleeve 6, inserts cup 2 into the pregnant woman's vaginal canal VG, and advances cup 2 deeply until the tip of cup 2 reaches the uterine cervical canal UC. While checking the fetal membrane VL under ultrasound guidance, the physician brings the tip of cup 2 close to and into contact with the fetal membrane VL. In this state, negative pressure is applied by suction means 5 to suction tube 3 pulled out of cup 2 of device 1, and the fetal membrane VL is attracted to the tip of cup 2, thereby puncturing the fetal membrane VL.

[0023] <Configuration of each part of Device 1> Next, the configuration of each part of the device 1 will be described. As shown in Figure 1, device 1 is a disposable device used in conjunction with an ultrasound probe. Device 1 comprises a cup 2 and a suction tube 3 connected to cup 2. Device 1 may also comprise a sleeve 6 that functions as a transvaginal probe cover.

[0024] The cup 2 is a component that is inserted into the vaginal canal VG of a pregnant woman and that directly punctures the amniotic membrane VL. FIG. 2 is a perspective view showing the configuration of the device 1, and FIG. 3 is a side cross-sectional view. The cup 2 is a cap-shaped cylindrical body with an open base end (rear end) 22c, and is a tubular soft member made of a flexible material that allows ultrasound to pass through. As shown in Figures 2 and 3, the cup 2 has a hemispherical tip portion 21 and a cylindrical tubular portion 22. Here, in this specification, the tip portion 21 refers to the portion of the outer surface of the cup 2 other than the tubular portion 22.

[0025] A hemispherical recess 23 is formed in the tip 21, a puncture needle 24 is embedded in the inner surface of the recess 23, and an air intake hole 23a is opened near the puncture needle 24 on the inner surface of the recess 23.

[0026] The puncture needle 24 is a needle-shaped member made of metal or hard resin, and its base end is embedded in the soft member that constitutes the recess 23, thereby forming a needle-shaped protrusion in the center of the bottom surface of the recess 23. The diameter of the puncture needle may be approximately 22G (0.7 mm). This prevents adverse events such as severe damage to the fetal membrane and maximum prolapse associated with fetal membrane damage. Furthermore, by constructing the puncture needle 24 from a resin material, it is possible to easily handle the cup 2 by medical personnel after surgery and prevent injury to their fingers.

[0027] An opening 22a large enough to allow the tip head portion 41 of the transvaginal ultrasound probe 4 to pass through is provided at the rear end 22c of the tube portion 22, and the transvaginal ultrasound probe 4 is configured to be able to enter up to the back surface 21a of the tip portion 21 through the tube inner cavity 22b.

[0028] In addition, the back surface 21a of the tip portion 21 is connected to one end of the suction tube 3 at a connection portion 25 provided at the outlet portion of the intake hole 23a to the cylindrical lumen 22b, so that the intake hole 23a and the lumen of the suction tube 3 are connected to each other.

[0029] One end of the suction tube 3 is connected to the air intake hole of the cup 2, and the other end is connected to the suction means 5, forming a suction tube circuit. The suction tube 3 is made of, for example, a transparent polyvinyl chloride tube or resin, and is configured so that the suction of amniotic fluid can be visually observed from outside the tube. Needless to say, the tube diameter and material are not limited.

[0030] The sleeve 6 is a cylindrical elastic member extending rearward from the rear end 22c of the cylindrical portion 22 of the cup 2. The sleeve 6 is made of, for example, rubber, polyurethane, elastomer, or the like, and may have a thickness of, for example, 0.05 mm to 1 mm and a length of, for example, 15 cm to 20 cm. The sleeve 6 may be bonded to the rear end 22c of the cylindrical portion 22, or may be formed integrally with the tip portion 21 and the cylindrical portion 22 of the cup 2.

[0031] The transvaginal ultrasound probe 4 is a commercially available transvaginal ultrasound diagnostic probe used for intracavity ultrasound diagnosis, such as rectal examination or transvaginal examination.

[0032] The suction means 5 is connected to the suction tube 3 drawn out from the cup 2 of the device 1, and is a suction means for applying negative pressure to the surgical site to suck and adsorb the fetal membrane VL to the tip 21 of the cup 2. It also functions as a suction means for aspirating and removing the amniotic fluid AF after puncture. The suction means 5 may be configured, for example, with an injection tube (syringe). For example, the negative pressure is applied manually using a 20-50 mL syringe, and the pressure is applied variably.

[0033] <Operation of Device 1> Next, the operation of the device 1 will be described. FIG. 4 is an enlarged view of part A in FIG. 1, and is a side cross-sectional view illustrating the operating state of the part of the puncture device 1 that is inserted into the body during surgery.

[0034] As shown in FIG. 4 , with the device 1, the distal head 41 of the transvaginal ultrasound probe 4 is inserted into the tubular lumen 22b of the cup 2 through the sleeve 6 extending from the rear end 22c of the cup 2. The cup 2 is then inserted into the vaginal canal VL, and the distal end 21 of the cup 2 is advanced deep into the effaced cervical canal UC, and brought into close contact with the fetal membrane VL to be destroyed under ultrasound guidance. At this time, the rear end 6a of the sleeve 6 is positioned outside the vaginal opening UL, and the sleeve 6 functions as a transvaginal probe cover. In this state, the fetal membrane VL is punctured and perforated by sucking the fetal membrane VL into the inner surface of the recess 23 containing the puncture needle 24 using the negative pressure of the suction means 5. This operation of the device 1 allows a small hole to be stably opened in the fetal membrane VL.

[0035] <Evaluation test> Performance evaluation was carried out by evaluation tests using examples of the device 1 according to the embodiment, and the results are described below.

[0036] (Example) A full-size usable prototype was created and evaluated as an example of the device 1. Figures 5(a) to 5(c) are photographs of the example of the device 1 taken from the side, front, and rear, respectively.

[0037] The cup 2 is a cylindrical body with an open base end (rear end) 22c and a hemispherical tip 21, an outer diameter of 18 mm, an inner diameter of 15 mm, and a length of 35 mm, as shown in Figures 2 and 3, and was made from an elastomer material using a 3D printer. The depth of the recess 23 was 8.0 mm, and the size of the air intake hole 23a was 2.0 mm. Note that the embodiment of the device 1 was configured without a sleeve 6.

[0038] The puncture needle 24 was a metal injection needle with a diameter of 22 gauge (outer diameter 0.7 mm), and was formed by embedding the base end in the center of the recess 23 of the tip 21 of the cup 2 so as to protrude 2 to 3 mm.

[0039] The suction tube 3 was a transparent vinyl chloride tube with an outer diameter of 2.0 mm, and was attached to the connecting portion 25 on the back surface 21a of the tip portion 21 of the cup 2 with an adhesive.

[0040] (Test equipment) A rubber membrane with a thickness of 0.1 to 0.5 mm, which imitates the egg membrane VL, was used as a sample test membrane to be perforated, and the opening of a cylindrical container with a bottom filled with water was sealed with the test membrane. The transvaginal ultrasound probe used was a 15 mm diameter transvaginal probe model 4'. The suction means used was a syringe with a capacity of 20 mL.

[0041] (Test Method) With the tip of the transvaginal probe morphological model 4' enclosed, the cup 2 was brought into contact with the test membrane at the opening of the container, and in this state, negative pressure was manually applied to the suction means to suck the test membrane into the cup 2. The negative pressure applied by the suction means was continued for approximately 6 seconds, and the state of water flowing into the suction tube 3 was observed.

[0042] (Test results) In an evaluation test using a rubber membrane according to the embodiment of the device 1, multiple punctures were completed. 6(a) to 6(c) are photographs showing the results of an evaluation test of the puncturing operation using an embodiment of the puncturing device 1, with Fig. 6(a) being a photograph before the start of the test, Fig. 6(b) being a photograph showing the state about 2 seconds after negative pressure was applied, and Fig. 6(c) being a photograph showing the state about 4 seconds after negative pressure was applied. Also, Fig. 7 is a photograph showing the state after about 6 seconds had passed and the cup 2 had stopped contacting the device and the negative pressure had been released.

[0043] When observing the suction tube 3 while negative pressure was applied, as shown in Figure 6(a), no water was flowing into the suction tube 3 before the start of the test. However, approximately 2 seconds after negative pressure was applied, water was observed to be flowing into the suction tube 3 as shown in Figure 6(b), and even after approximately 4 seconds, water containing air bubbles was observed to be flowing into the suction tube 3 as shown in Figure 6(c).

[0044] Furthermore, when the cup 2 was released from the contact and the negative pressure was released approximately 6 seconds after the negative pressure was applied, it was confirmed that water from inside the container was dripping from the test membrane, as shown in Figure 7, and it was confirmed that the test membrane had been perforated.

[0045] From the above results, according to the embodiment of the puncture device 1, the fetal membrane VL is sucked by negative pressure, and is damaged by the puncture needle 24 installed inside the cup 2, completing the perforation and achieving the purpose of artificial membrane rupture. It was confirmed that the damage to the fetal membrane VL causes amniotic fluid AF to be sucked into the suction tube 3, making it possible to visually confirm the success of the puncture from the outside.

[0046] <Summary> As described above, the puncturing device 1 according to the embodiment is a puncturing device 1 for transvaginally puncturing the fetal membrane VL, and is a cap-shaped cylindrical body with opening 22a at base end (rear end) 22c. It comprises cup 2 having recess 23 at tip 21, puncturing needle 24 on the inner surface of recess 23, and air suction hole 23a, and suction tube 3 having one end connected to air suction hole 23a of cup 2 and the other end connectable to suction means 5. When tip 21 of cup 2 is brought close to the fetal membrane VL transvaginally, the negative pressure from suction means 5 can be used to suck the fetal membrane VL into the inner surface of recess 23, including puncturing needle 24.

[0047] In other words, device 1 has the characteristic of slowly adsorbing and suctioning the amniotic membrane VL that it comes into contact with transvaginally using external negative pressure, and can realize a mechanism that inflicts minor damage to the amniotic membrane VL without causing a large amount of amniotic fluid to leak out.

[0048] This configuration provides a puncture device 1 that can stably puncture a small hole in the amniotic membrane VL during artificial amniotic rupture. This makes it possible to suppress the sudden outflow of amniotic fluid that accompanies a defect in the amniotic membrane during artificial amniotic rupture. As a result, it is possible to prevent, for example, fetal dysfunction that accompanies the sudden outflow of amniotic fluid, and particularly serious complications such as umbilical cord prolapse, in which the umbilical cord prolapses along with the amniotic fluid and becomes trapped, causing permanent ischemia in the fetus.

[0049] In another embodiment, the cup 2 may be a tubular soft member made of a flexible material that is permeable to ultrasound, and may be configured so that the transvaginal ultrasound probe 4 can enter the back surface 21a of the recess 23 through the tubular cavity 22b.

[0050] With this configuration, compared to conventional procedures in which the amniotic membrane is blindly grasped and damaged, the tip 21 of the cup 2 can be brought close to and into contact with the amniotic membrane VL while checking the amniotic membrane VL under ultrasound guidance. This avoids blind puncture of the amniotic membrane VL, and even in cases where the fetal head and the amniotic membrane VL are close together, such as in cases of oligohydramnios, safe puncture can be performed under ultrasound guidance while being aware of the presence of the fetal head, ensuring safety for the fetus FT. In another embodiment, the puncture needle 24 may be configured to be formed by embedding the base end of a needle-shaped metal or hard resin member into the inner surface of the recessed portion 23.

[0051] This configuration allows a small hole to be stably opened in the fetal membrane VL, preventing adverse events such as gross fetal membrane damage and maximum prolapse associated with fetal membrane damage.

[0052] In another embodiment, the suction tube 3 may be configured so that the suction of amniotic fluid can be visually observed from outside the tube.

[0053] With this configuration, the success of the puncture can be confirmed externally by observing the state in which the amniotic fluid AF is being aspirated.

[0054] In another embodiment, a sleeve 6 made of an elastic member may be configured to extend from the base end (rear end) 22c of the cup 2 by a predetermined length.

[0055] With this configuration, the sleeve 6 can function as a transvaginal probe cover.

[0056] <<Variations>> While the specific configuration of the present disclosure has been described above using the embodiments as examples, the present disclosure is not limited to the above embodiments except for the essential characteristic components thereof. For example, the present disclosure also includes forms obtained by various modifications to the embodiments and forms realized by arbitrarily combining the components and functions of each embodiment within the scope of the present invention. Below, a modified example will be described as an example of such a configuration.

[0057] (1) In the above embodiment, the cup 2 is made of a material that allows ultrasound to pass through, and the transvaginal ultrasound probe 4 can be inserted through the cylindrical lumen 22b to the rear surface 21a of the recess 23. However, the device 1 may be configured so that the fetal membrane VL can be sucked into the inner surface of the recess 23, including the puncture needle 24, by negative pressure, and the transvaginal ultrasound probe 4 need not be inserted into the cup 2. Alternatively, a method of contacting a separate ultrasound probe with the body surface may be used.

[0058] (2) In the above embodiment, a medical device for transvaginally puncturing the amniotic membrane to allow a doctor to artificially rupture the amniotic membrane was described. However, the biological membrane to be punctured may be other than the amniotic membrane, and device 1 may be used as a medical device for slowly adsorbing and perforating a body membrane present in the body through a body cavity using external negative pressure, in addition to a puncturing device for transvaginally puncturing the amniotic membrane.

[0059] <<Additional Information>> The embodiments described above each illustrate a preferred specific example of the present invention. The numerical values, shapes, materials, components, component placement and connection configurations, steps, and step sequences shown in the embodiments are merely examples and are not intended to limit the present invention. Furthermore, among the components in the embodiments, those not described in the independent claims that represent the highest concept of the present invention are described as optional components that constitute more preferred embodiments.

[0060] The order in which the above methods are performed is merely an example for specifically explaining the present invention, and other orders may be used. Also, some of the above methods may be performed simultaneously (in parallel) with other methods.

[0061] In order to facilitate understanding of the invention, the scale of the components in the drawings of the above embodiments may differ from the actual scale. Furthermore, the present invention is not limited to the description of the above embodiments, and can be modified as appropriate within the scope of the gist of the present invention. Furthermore, at least some of the functions of the embodiments and their modifications may be combined. [Industrial Applicability]

[0062] The puncturing device according to one aspect of the present disclosure can be used as a puncturing device for transvaginally puncturing the amniotic membrane, and can also be widely used as a medical device for perforating membranes present throughout the body through a body cavity, in addition to the amniotic membrane. [Explanation of symbols]

[0063] 1 Lancing device 2 cups 21 Tip 21a Back side 22 Cylinder part 22a opening 22b Cylinder bore 23 Depression 23a Air intake 24 Puncture needle 25 Connection 3 Suction tube 4. Transvaginal ultrasound probe 41 Tip head 5 Suction means 6 sleeves

Claims

1. A puncturing device for transvaginally puncturing the amniotic membrane, a cup that is a cap-shaped cylindrical body with an open base end, a recessed portion at the tip end, a puncture needle on the inner surface of the recessed portion, and an air intake hole; a suction tube having one end connected to the intake hole of the cup and the other end connectable to a suction means; Puncture device.

2. The puncture needle is configured to suck the amniotic membrane to the inner surface of the recessed portion including the amniotic membrane by negative pressure from the suction means while the tip of the cup is brought into close proximity to the amniotic membrane through the vagina. The lancing device of claim 1 .

3. The cup is a tubular soft member made of a flexible material that is permeable to ultrasound, and is configured so that a transvaginal ultrasound probe can be inserted through the lumen of the tube to the rear surface of the recessed portion. The lancing device of claim 1 .

4. The puncture needle is formed by embedding a base end of a needle-shaped metal or hard resin member into the inner surface of the recessed portion. The lancing device of claim 1 .

5. The suction tube is configured so that the suction of amniotic fluid can be visually observed from outside the tube. The lancing device of claim 1 .

6. A sleeve made of an elastic material extends a predetermined length from the base end of the cup. The lancing device of claim 1 .

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