Artificial membrane rupture and amniotic fluid collector

Abstract

The invention relates to the field of gynecological or obstetrical instruments, and discloses an artificial membrane rupture and amniotic fluid collector which comprises a membrane rupture probe, the tail of the membrane rupture probe is connected with a handle, the membrane rupture probe comprises an outer sleeve and a membrane rupture rod slidably arranged in the outer sleeve, and the head of the membrane rupture rod is provided with a membrane rupture tip. A driving device for driving the membrane rupture rod to stretch back and forth is arranged in the handle, the driving device is connected with the membrane rupture rod, and a depth limiting assembly is arranged at the joint of the driving device and the membrane rupture rod; an amniotic fluid channel is formed in the membrane rupture probe; a flow guide pipe is arranged on one side, close to the handle, of the membrane rupture probe and is communicated with the amniotic fluid channel; a supporting air bag is fixed to the periphery of the head of the membrane rupture probe, an inflation channel is arranged in the membrane rupture probe, one end of the inflation channel is communicated with the supporting air bag, and the other end of the inflation channel is communicated with an inflation and deflation device installed in the handle. The problems that in the prior art, the membrane rupture risk is high, amniotic fluid is difficult to collect, and the occupational exposure risk of medical staff is large can be solved.

Description

Technical Field

[0001] This invention relates to the field of gynecological or obstetric instruments, specifically to an artificial membrane rupture device and amniotic fluid collector. Background Technology

[0002] Artificial rupture of membranes (APRM) is a common method of inducing labor during natural childbirth. It involves artificially tearing the amniotic membrane at the cervix to observe the color of the amniotic fluid, strengthen uterine contractions, and accelerate the progress of labor. The traditional procedure involves the pregnant woman emptying her bladder and lying in the lithotomy position. After strict disinfection of the vulva and vagina, aseptic techniques are employed. The left index finger is inserted into the vagina to guide the flow, while the right hand holds instruments such as an artificial rupture needle, rat-tooth forceps, or tissue forceps to rupture the amniotic membrane during the intervals between contractions. After rupture, amniotic fluid flows out, and its volume and characteristics are carefully observed. In the past, artificial rupture of membranes mainly relied on medical staff using instruments and their rich experience and keen sense of touch to carry out the operation. However, this method has obvious drawbacks. It requires a very high level of technical skill from medical staff. Precisely grasping the timing of membrane rupture and properly controlling the force of rupture are quite difficult. Even a slight deviation may affect the progress of labor or even endanger the safety of the mother and baby. Currently, amniotic fluid collection often involves using ordinary containers placed under the mother to collect the fluid. This method is inefficient, and the amniotic fluid is prone to spillage, polluting the surrounding environment and significantly increasing the occupational exposure risk for healthcare workers as the fluid may carry pathogens such as hepatitis B, hepatitis C, and HIV. When the amniotic sac is ruptured, the amniotic fluid often sprays out. While disposable protective clothing and other protective equipment offer some protection, they cannot completely eliminate the problem of amniotic fluid splashing. Although some improved products have been introduced to the market, they still have many shortcomings in key areas such as automated rupture of the amniotic sac, efficient amniotic fluid collection, and comprehensive protection, failing to fully meet the urgent clinical needs for safety and efficiency. Summary of the Invention

[0003] The present invention aims to provide an artificial membrane rupture device and an amniotic fluid collector to solve the problems of high risk of membrane rupture, difficulty in amniotic fluid collection, and high occupational exposure risk for medical staff in the prior art.

[0004] To achieve the above objectives, the present invention adopts the following technical solution: An artificial membrane rupture and amniotic fluid collector includes a membrane rupture probe with a handle connected to its tail. The membrane rupture probe includes an outer sleeve and a membrane rupture rod slidably disposed within the outer sleeve. The head of the membrane rupture rod is provided with a membrane rupture tip. A drive device for driving the membrane rupture rod to extend and retract is provided inside the handle. The drive device is connected to the membrane rupture rod, and a depth limiting component is provided at the connection point. An amniotic fluid passage is provided inside the membrane rupture probe. A guide tube is provided on the side of the membrane rupture probe near the handle, communicating with the amniotic fluid passage. The other end of the guide tube is connected to a collection bag. A support airbag is fixed to the outer periphery of the head of the membrane rupture probe. An inflation channel is provided inside the membrane rupture probe. One end of the inflation channel is connected to the support airbag, and the other end of the inflation channel is connected to an inflation / deflation device installed inside the handle.

[0005] Preferably, as an improvement, the drive device includes a micro motor, a main button on the handle, a controller electrically connected to the main button, the controller electrically connected to the micro motor, a sleeve connected to the output end of the micro motor, a rod head threadedly connected to the sleeve, the rod head passing through a through hole on the handle and connected to a film-breaking rod, an anti-rotation strip provided at the through hole on the handle, an anti-rotation groove axially opened on the rod head, the anti-rotation strip being engaged in the anti-rotation groove, and a depth limiting component including a limiting step fixed to the free end of the sleeve.

[0006] Preferably, as an improvement, the handle is detachably connected to the membrane rupture probe.

[0007] Preferably, as an improvement, a ring-shaped connector is fixed on the handle, the free end of the rod head passes through the connector, the tail of the membrane breaking probe has an insertion hole that is interference-fitted with the connector, the free end of the connector is tapered, the tail of the membrane breaking rod has a connecting square hole, the free end of the rod head is fixed with a connector that is interference-fitted with the connecting square hole, the free end of the connector is also tapered; the inflation / deflation port of the inflation / deflation device is connected to an inflation / deflation connector, the inflation / deflation connector protrudes from the handle, the inflation / deflation connector can be interference-fitted with the inflation channel, and the free end of the inflation / deflation connector is tapered.

[0008] Preferably, as an improvement, a sealing ring is provided on the inner wall of the end where the air passage connects to the air inlet / outlet connector.

[0009] Preferably, as an improvement, the guide tube is detachably connected to the collection bag.

[0010] Preferably, as an improvement, the collection bag is a transparent collection bag.

[0011] Preferably, as an improvement, the collection bag is provided with scale lines.

[0012] Preferably, as an improvement, the handle is provided with a mounting cavity, the drive device is disposed in the mounting cavity, and a cover plate is detachably installed at the opening of the mounting cavity.

[0013] Preferably, as an improvement, the end of the supporting airbag facing the head of the rupture probe is integrally connected with an airbag ring, and after the airbag ring is inflated, a collection area for amniotic fluid is formed between it and the rupture probe.

[0014] The principles and beneficial effects of this solution are as follows: 1. In practical application, medical staff hold the handle and insert the membrane rupture probe into the vagina, aligning it with the amniotic sac. Using the main button on the handle, the extension length of the rupture probe is selected according to the mother's specific situation. A micro-motor drives the sleeve to rotate, which in turn extends the rupture probe through the rod head. When the set depth is reached, the probe stops advancing, thus rupturing the amniotic sac. This method, by controlling the extension length of the rupture probe via the main button, allows for precise control of the rupture depth, effectively avoiding complications such as cervical injury and umbilical cord prolapse caused by improper rupture depth or force, thus improving the safety and accuracy of the rupture procedure.

[0015] 2. Building upon the above, a support balloon is circumferentially positioned at the tip of the amniotic sac rupture probe. After insertion, the balloon inflates and adheres to the vaginal wall, providing support to the vagina and sealing the area between the rupture tip and the balloon. When the amniotic sac ruptures, the ejected amniotic fluid is blocked by the balloon, preventing leakage and potential contamination of medical staff. Furthermore, the balloon concentrates the amniotic fluid in this area, allowing it to flow more smoothly and quickly through the amniotic duct to the collection bag. The collection bag is transparent and graduated, allowing for direct observation of the amount and characteristics of the amniotic fluid.

[0016] 3. The membrane rupture probe and handle are detachably connected. In practical applications, the membrane rupture probe can be used as a disposable medical material. When needed, it can be removed from the packaging and installed on the handle. Each person uses a single-use probe, ensuring greater safety and hygiene. The membrane rupture probe can be quickly installed on the handle by inserting the connector on the handle into the connector hole on the membrane rupture probe, and simultaneously inserting the connector on the rod end into the connecting square hole on the membrane rupture rod. The interference fit between the connector and the connector ensures the stability of the connection between the membrane rupture probe and the handle. Furthermore, when the membrane rupture probe is inserted into the handle, the inflation / deflation connector on the handle is also interference-fitted into the inflation channel, achieving automatic connection between the inflation / deflation device and the inflation channel. This connection between the inflation / deflation connector and the inflation channel also increases the connection points between the membrane rupture probe and the handle, further ensuring the stability of the connection.

[0017] 4. A mounting cavity is provided inside the handle for installing the drive device, and a cover plate is provided to open the mounting cavity for inspection and maintenance of the various components of the drive device.

[0018] 5. The end of the supporting airbag facing the head of the rupture probe is integrally connected with an airbag ring, forming a cylindrical airbag that fits over the rupture probe. After the airbag ring is inflated, a gap is formed between it and the outer wall of the rupture probe, thus forming an amniotic fluid collection area. On the one hand, this allows the amniotic fluid to collect around the outer sleeve so that the amniotic fluid can flow out better along the amniotic fluid passage. On the other hand, the large area structure of the airbag ring enhances the support effect of the vaginal wall and the sealing effect of the vaginal wall against the amniotic fluid, further preventing the amniotic fluid from flowing out along the vagina. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the structure of Embodiment 1 of the present invention.

[0020] Figure 2 for Figure 1 An enlarged schematic diagram of part A in the middle.

[0021] Figure 3 This is a front view of the tail of the membrane-breaking probe in Embodiment 1 of the present invention.

[0022] Figure 4 This is a cross-sectional view of the supporting airbag in Embodiment 4 of the present invention.

[0023] Figure 5 This is a cross-sectional view of the supporting airbag in Embodiment 5 of the present invention.

[0024] The reference numerals in the accompanying drawings of the instruction manual include: handle 1, outer sleeve 2, inflation channel 3, guide tube 4, collection bag 5, membrane rupture rod 6, amniotic fluid flow channel 7, support airbag 8, membrane rupture tip 9, main button 10, motor bracket 11, micro motor 12, flange 13, sleeve 14, rod head 15, cover plate 16, bolt 17, inflation / deflation device 18, inflation / deflation connector 19, connector 20, plug connector 21, plug hole 22, connecting square hole 23, airbag ring 24, anti-rotation strip 25, support ring 26. Detailed Implementation

[0025] The present invention will be further described in detail below with reference to the embodiments. Example 1 like Figure 1 , Figure 2 and Figure 3As shown, the artificial membrane rupture and amniotic fluid collection device includes a membrane rupture probe and a handle 1. The membrane rupture probe includes an outer sleeve 2 and a membrane rupture rod 6 slidably connected inside the outer sleeve 2. A sealing ring is glued to the inner wall of the head of the outer sleeve 2 (right side in the figure) to ensure the airtightness of the channel where the membrane rupture rod 6 is located. The head of the membrane rupture rod 6 has an integrally formed membrane rupture tip 9. An amniotic fluid flow channel 7 is machined inside the membrane rupture probe. The front end of the amniotic fluid flow channel 7 passes through the head of the membrane rupture probe. A guide tube 4 is installed on one side of the tail of the membrane rupture probe. The guide tube 4 is tightly connected to the amniotic fluid flow channel 7 through a pipe connector. The other end of the guide tube 4 is located outside the membrane rupture probe and is connected to a collection bag 5 through a pipe connector. The collection bag 5 is a transparent collection bag with scale lines, such as the drainage bag used in hospitals in the prior art. The outer periphery of the membrane rupture probe head is glued and fixed with an annular support airbag 8. The membrane rupture probe has an inflation channel 3 inside. One end of the inflation channel 3 is tightly connected to the support airbag 8, and the other end of the inflation channel 3 is connected to the inflation / deflation device 18 installed in the handle 1. The inflation / deflation device 18 adopts a miniature air pump.

[0026] The membrane rupture probe is made of disposable medical materials. The tail end of the probe is detachably connected to the head of the handle 1, allowing for one-time replacement of the probe. Specifically, as follows... Figure 2 As shown, the handle 1 has a machined mounting cavity, in which a drive device for driving the film-breaking rod 6 to extend and retract is installed. A cover plate 16 is detachably installed at the opening of the mounting cavity via bolts 17. The drive device includes a micro motor 12, which is mounted in the mounting cavity via a motor holder 11. The output end of the micro motor 12 is connected to a sleeve 14 via a flange 13. A rod head 15 is threaded onto the sleeve 14. The rod head 15 passes through a through hole on the head of the handle 1. An anti-rotation strip 25 is fixed to the inner wall of this through hole by screws. An anti-rotation groove is axially formed on the rod head 15, and the anti-rotation strip 25 is engaged in the anti-rotation groove. A limiting step is integrally formed at the free end of the sleeve 14 to limit the tail of the rod head 15. An annular connector 21 is integrally formed at the head of the handle 1, and a connector 20 is integrally formed at the free end of the rod head 15. The free end of the rod head 15 passes into the connector 21, and the connector 20 protrudes from the connector 21. Figure 3As shown, the outer sleeve 2 has an insertion hole 22 at its tail end that is interference-fitted with the connector 21. The free end of the connector 21 is tapered to allow insertion into the insertion hole 22. A sealing gasket is glued to the end face of the outer sleeve 2 to ensure a tight seal between the two after the membrane breaking probe is installed on the handle 1. The membrane breaking rod 6 has a connecting square hole 23 at its tail end that is interference-fitted with the connector 20. The free end of the connector 20 is also tapered to allow insertion into the connecting square hole 23. In addition, the inflation / deflation device 18 has a rigid inflation / deflation connector 19 connected to its inflation / deflation port. The inflation / deflation connector 19 protrudes from the head of the handle 1 and can be interference-fitted with the inflation channel 3. The free end of the inflation / deflation connector 19 is tapered to allow insertion into the inflation channel 3. A sealing ring is snapped and fixed on the inner wall of the inflation channel 3 where it connects to the inflation / deflation connector 19. The handle 1 is equipped with a main button 10 and an inflation / deflation button. The inflation / deflation button is used to control the inflation / deflation of the inflation / deflation device 18. The main button 10 is electrically connected to the controller, and the micro motor 12 is electrically connected to the controller. The controller is a PLC or a microcontroller. The handle 1 is also equipped with a rechargeable battery to provide power to the controller, the micro motor 12 and the inflation / deflation device 18.

[0027] Working principle: Take a disposable membrane breaking probe, tear open the packaging, and install the membrane breaking probe onto the handle 1. During installation, the connector 21 on the handle 1 is inserted into the connector hole 22 on the membrane breaking probe, and at the same time, the connector 20 on the rod head 15 is inserted into the connecting square hole 23 on the membrane breaking rod 6. At the same time, the inflation / deflation connector 19 on the handle 1 is inserted into the inflation channel 3 on the membrane breaking probe, so as to realize the automatic connection between the inflation / deflation device 18 and the inflation channel 3.

[0028] After installation, use a vaginal speculum to open the vaginal opening, making it easier for medical staff to view the internal condition. Hold handle 1 and insert the membrane rupture probe into the vagina. During insertion, the support balloon 8 should adhere to the surface of the membrane rupture probe without affecting its insertion. Stop insertion when the head of the membrane rupture probe is close to the amniotic sac. It should be noted that handle 1 is located outside the body during use; therefore, the structure of handle 1 can be designed to be slightly larger for gripping and installing the internal structure.

[0029] After the membrane rupture probe is inserted into place, the inflation / deflation button is pressed to activate the inflation / deflation device 18, which inflates the support balloon 8. The inflated support balloon 8 then adheres to the vaginal wall, supporting the vagina while simultaneously blocking the area between the probe head and the balloon 8, creating a space for amniotic fluid to collect and drain. Next, the main button 10 is pressed to select the extension length of the membrane rupture rod 6 (depending on the patient's condition). The main button 10 sends a signal to the controller, which controls the micro-motor 12 to rotate the sleeve 14. The sleeve 14, through the rod head 15, slowly extends the membrane rupture rod 6 from the outer sleeve 2 to a predetermined length (the micro-motor 12 is set to a low-speed motor to achieve a slow extension of the membrane rupture rod 6), rupturing the amniotic membrane with the membrane rupture tip 9. After the amniotic sac ruptures, amniotic fluid is ejected into the area sealed by the support balloon 8, which effectively prevents the amniotic fluid from flowing out along the vagina. The pressurized amniotic fluid gathers in this area and flows out through the amniotic fluid channel 7 into the collection bag 5. The transparent collection bag 5 with graduations makes it easy for doctors to observe the amount and characteristics of the amniotic fluid.

[0030] After amniotic fluid collection is complete, press the button again. The micro motor 12 reverses its movement, causing the membrane rupture rod 6 to retract, pulling the membrane rupture tip 9 back into the outer sleeve 2. Then, the inflation / deflation device 18 deflates the support airbag 8. After deflation, the support airbag 8 adheres to the membrane rupture probe, facilitating its removal. After removing the membrane rupture probe, detach it from the handle 1 and discard it.

[0031] Example 2 The difference between this embodiment and embodiment 1 is that the guide tube 4 and the collection bag 5 are detachably connected, specifically adopting the connection method of the drainage bag and the drainage tube in the prior art.

[0032] Example 3 The difference between this embodiment and Embodiment 1 is that a fastening sleeve is threaded onto the outer wall of the tail end of the outer sleeve 2, and the head of the handle 1 has an annular threaded hole that mates with the fastening sleeve. When the membrane rupture probe is inserted into the handle 1, the fastening sleeve can be screwed onto the tail end of the outer sleeve 2, and a portion of the fastening sleeve can be screwed into the threaded hole, further strengthening the connection between the membrane rupture probe and the handle 1. It should be noted that in actual use, the tail end of the outer sleeve 2 does not extend into the human body, therefore the presence of the fastening sleeve will not affect the patient.

[0033] Example 4 Combination Figure 4As shown, the difference between this embodiment and Embodiment 2 is that the end of the supporting airbag 8 facing the head of the rupture probe is integrally connected to an airbag ring 24, making the supporting airbag 8 a cylindrical airbag as shown in the figure. When the supporting airbag 8 and the airbag ring 24 are inflated, an amniotic fluid collection area is formed between the airbag ring 24 and the outer sleeve 2. On the one hand, this allows the amniotic fluid to collect around the outer sleeve 2 so that the amniotic fluid can flow out better along the amniotic fluid passage 7. On the other hand, the large area structure of the airbag ring 24 enhances the support effect of the vaginal wall and the sealing effect of the vaginal wall against the amniotic fluid, further preventing the amniotic fluid from flowing out along the vagina. Furthermore, the airbag ring 24 is designed with an arc, which can buffer the pressure of the amniotic fluid, thereby ensuring the structural strength at this point and ensuring the support effect of the vaginal wall.

[0034] Example 5 like Figure 5 As shown, the difference between this embodiment and embodiment 4 is that the free end (right end) of the airbag ring 24 is aligned with the head of the outer sleeve 2, and the inner wall of the airbag ring 24 is a non-elastic support ring 26. That is, when inflated, the support airbag 8 bulges in the radial direction, and the airbag ring 24 also bulges only in the radial direction, while it does not expand or contract in the axial direction because the inner ring is a non-elastic support ring 26.

[0035] In this embodiment, after inflation, an amniotic fluid collection area still forms between the outer sleeve 2 and the airbag ring 24. After deflation, the supporting airbag 8 and the airbag ring 24 shrink and deflate radially, while the length of the airbag ring 24 remains unchanged. Therefore, after deflation, the cylindrical airbag can act as a protective sleeve to adhere to the outer wall of the outer sleeve 2, and the right end of the airbag ring 24 is aligned with the head of the outer sleeve 2. This can wrap the area of ​​the outer sleeve 2 that comes into contact with the amniotic fluid inside the airbag ring 24, thereby preventing medical staff from coming into contact with the amniotic fluid remaining on the outer sleeve 2, and further eliminating contact between medical staff and the amniotic fluid.

[0036] The above descriptions are merely embodiments of the present invention, and common knowledge such as specific technical solutions and / or characteristics are not described in detail here. It should be noted that those skilled in the art can make various modifications and improvements without departing from the technical solutions of the present invention, and these should also be considered within the scope of protection of the present invention. These modifications and improvements will not affect the effectiveness of the implementation of the present invention or the practicality of the patent. The scope of protection claimed in this application should be determined by the content of its claims, and the specific embodiments described in the specification can be used to interpret the content of the claims.

Claims

1. An artificial amniocentesis and amniotic fluid collection device, characterized in that: The device includes a membrane rupture probe with a handle connected to its tail. The probe includes an outer sleeve and a membrane rupture rod slidably disposed within the outer sleeve. The head of the membrane rupture rod has a membrane rupture tip. A drive device for extending and retracting the membrane rupture rod is located within the handle. The drive device is connected to the membrane rupture rod, and a depth limiting component is provided at the connection point. An amniotic fluid passage is located within the membrane rupture probe. A guide tube is located on the side of the membrane rupture probe near the handle, communicating with the amniotic fluid passage. The other end of the guide tube is connected to a collection bag. A support airbag is fixed to the outer periphery of the probe head. An inflation channel is located inside the membrane rupture probe, with one end communicating with the support airbag and the other end communicating with an inflation / deflation device installed within the handle.

2. The artificial membrane rupture and amniotic fluid collector according to claim 1, characterized in that: The drive device includes a micro motor, a main button on the handle, a controller electrically connected to the main button, the controller electrically connected to the micro motor, a sleeve connected to the output end of the micro motor, a rod head connected to the internal thread of the sleeve, the rod head passing through a through hole on the handle and connected to the film breaking rod, an anti-rotation strip provided at the through hole on the handle, an anti-rotation groove axially opened on the rod head, the anti-rotation strip being engaged in the anti-rotation groove, and a depth limiting component including a limiting step fixed to the free end of the sleeve.

3. The artificial membrane rupture and amniotic fluid collection device according to claim 2, characterized in that: The handle and the membrane breaking probe are detachably connected.

4. The artificial membrane rupture and amniotic fluid collection device according to claim 3, characterized in that: A ring-shaped connector is fixed on the handle, and the free end of the rod head passes through the connector. The tail of the membrane breaking probe has an insertion hole that is interference-fitted with the connector. The free end of the connector is tapered. The tail of the membrane breaking rod has a connecting square hole. The free end of the rod head is fixed with a connector that is interference-fitted with the connecting square hole. The free end of the connector is also tapered. The inflation / deflation port of the inflation / deflation device is connected to an inflation / deflation connector. The inflation / deflation connector protrudes from the handle and can be interference-fitted with the inflation channel. The free end of the inflation / deflation connector is tapered.

5. The artificial membrane rupture and amniotic fluid collector according to claim 4, characterized in that: A sealing ring is provided on the inner wall of the end where the air channel connects to the air inlet / outlet connector.

6. The artificial membrane rupture and amniotic fluid collection device according to claim 5, characterized in that: The guide tube and the collection bag are detachably connected.

7. The artificial membrane rupture and amniotic fluid collector according to claim 6, characterized in that: The collection bags are transparent.

8. The artificial membrane rupture and amniotic fluid collector according to claim 7, characterized in that: The collection bag has graduated lines.

9. The artificial membrane rupture and amniotic fluid collector according to claim 8, characterized in that: The handle has a mounting cavity, the drive unit is located inside the mounting cavity, and a cover plate can be detachably installed at the opening of the mounting cavity.

10. The artificial membrane rupture and amniotic fluid collector according to claim 9, characterized in that: The end of the supporting airbag facing the head of the rupture probe is integrally connected to an airbag ring. After the airbag ring is inflated, a collection area for amniotic fluid is formed between it and the rupture probe.

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