A multi-functional device for amniocentesis, amniotic fluid collection, amniotic sac occlusion, and labor induction.

Abstract

This invention relates to the field of medical device technology, specifically to a multifunctional device for amniocentesis, amniotic fluid collection, amniocentesis closure, and labor induction. The device includes: a first sac placed vaginally into the cervix; fluid is added to the first sac to change its volume and support the amniotic sac; a catheter is located within a channel on the first sac; a puncture needle is located within the channel; the puncture needle extends and punctures the amniotic sac, allowing amniotic fluid to flow into the catheter; a collector is connected to the catheter to store the amniotic fluid. This application allows the puncture needle to be inserted through the vagina and cervix to puncture the amniotic sac and release amniotic fluid, reducing surgical risks. Simultaneously, for pregnant women with premature rupture of membranes, amniotic fluid is collected for pathogen testing. The first sac supports the amniotic sac and seals the rupture. For patients with premature rupture of membranes requiring labor induction, the first sac is filled with fluid, increasing its volume and stimulating the release of prostaglandins, promoting cervical ripening, softening the cervix, and inducing labor. This application can be used in multiple scenarios and has comprehensive functions.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a multifunctional device for amniocentesis, amniotic fluid collection, amniocentesis occlusion, and labor induction. Background Technology

[0002] Pregnant women with excessive amniotic fluid need to undergo amniocentesis before delivery to prevent amniotic fluid embolism during labor and postpartum. This is usually done via ultrasound-guided transabdominal puncture, an invasive procedure that may cause uterine contractions or rapid changes in amniotic fluid volume, potentially leading to placental abruption. Additionally, for preterm pregnant women with premature rupture of membranes, it's necessary to determine if infection caused the premature rupture, whether pathogens are present in the amniotic fluid, and to collect amniotic fluid for bacterial culture and measurement.

[0003] Therefore, the above-mentioned transabdominal amniocentesis technique has safety risks and limited functionality. Summary of the Invention

[0004] Therefore, the technical problem to be solved by the present invention is to overcome the defects of transabdominal amniocentesis, which has safety risks and limited functionality.

[0005] To overcome the above-mentioned defects, the present invention provides a multifunctional device for amniocentesis, amniotic fluid collection, amniocentesis occlusion, and labor induction, comprising:

[0006] The first sac is adapted to be placed in the cervix via the vagina, and is adapted to be filled with fluid to change its volume in order to support the amniotic sac.

[0007] The catheter is located within a channel provided on the first capsule;

[0008] A puncture needle is located within the channel; the puncture needle is adapted to extend and puncture the amniotic sac, allowing amniotic fluid from the amniotic sac to flow into the catheter.

[0009] A collector, connected to a catheter, is adapted to store amniotic fluid flowing in through the catheter.

[0010] Optionally, it also includes:

[0011] A cover is rotatably connected to one end of the channel near the amniotic sac, the cover being adapted to rotate to close or open the inlet of the catheter; when the cover closes the inlet of the catheter, the cover is in contact with the amniotic sac.

[0012] Optionally, it also includes:

[0013] The inner end of the first guidewire is connected to the cap near the rotating end, and the outer end of the first guidewire passes through the wall of the catheter, passes through the channel through the first capsule, and extends to the outside; the outer end of the first guidewire is adapted to push and pull to rotate the cap.

[0014] Optionally, it also includes:

[0015] The second capsule is adapted to be placed at the upper end of the vagina and is adapted to be filled with fluid to change its volume for fixed support; the catheter passes through the second capsule.

[0016] Optionally, it also includes:

[0017] A first filling / discharging assembly passes through a pipe through a second bladder and is connected to the first bladder. The first filling / discharging assembly is adapted to fill or discharge fluid into the first bladder.

[0018] A second inflation / deflation assembly is connected to a second capsule and is adapted to inflate or deflate fluid into the second capsule.

[0019] Optionally, both the first and second capsules are balloons.

[0020] Optionally, an epidermal growth factor release medium is coated on the tip of the first capsule.

[0021] Optionally, the tip of the first sac is adapted to abut against the amniotic sac.

[0022] Optionally, it also includes:

[0023] The second guidewire has its inner end connected to the puncture needle, and its outer end passes through the channel through the first capsule and extends to the outside; the outer end of the second guidewire is adapted to push and pull to extend and retract the puncture needle.

[0024] Optionally, it also includes:

[0025] A protective shell is fixedly disposed between the first capsule and the catheter, and the puncture needle and part of the second guidewire are both sleeved inside the protective shell;

[0026] A baffle is fixedly installed inside the protective shell; a through hole is provided on the baffle; the second guide wire passes through the through hole; a limiting structure is provided on the second guide wire on the side of the baffle near the puncture needle, the limiting structure being adapted to prevent the part of the second guide wire connected to the puncture needle from coming out of the protective shell.

[0027] The technical solution of the present invention has the following advantages compared with the prior art:

[0028] 1. The present invention provides a multifunctional device for amniocentesis, amniotic fluid collection, amniotic sac occlusion, and labor induction, comprising: a first sac body, adapted for placement in the cervix via the vagina, and adapted to be filled with fluid to change its volume and support the amniotic sac; a catheter located within a channel provided on the first sac body; a puncture needle located within the channel; the puncture needle is adapted to extend and puncture the amniotic sac, allowing amniotic fluid in the amniotic sac to flow into the catheter; and a collector connected to the catheter, adapted to store the amniotic fluid flowing in through the catheter. This application employs the above technical solution, allowing the puncture needle to enter through the vagina and cervix, puncturing the amniotic sac and releasing amniotic fluid, thus reducing surgical risks. Simultaneously, for pregnant women with premature rupture of membranes, amniotic fluid can be collected for pathogen testing, and the outflowing amniotic fluid can be precisely measured; based on the pathogen test results, targeted anti-inflammatory treatment can be administered, increasing the chances of successful pregnancy maintenance. In addition, for patients with premature rupture of membranes requiring induction of labor, while collecting amniotic fluid, the first sac in the cervix can be filled with a larger amount of fluid, increasing its size and bulging. This stimulates the release of endogenous prostaglandins, promoting uterine contractions and cervical ripening, thus softening the cervix and inducing labor. The technical solution presented in this application can be used in multiple scenarios and is fully functional.

[0029] 2. The multifunctional device for amniocentesis, amniotic fluid collection, amniotic sac closure, and labor induction provided by the present invention further includes: a cover, rotatably connected to one end of the channel near the amniotic sac, the cover being adapted to rotate and close or open the inlet of the catheter; when the cover closes the inlet of the catheter, the cover is in contact with the amniotic sac; the present application adopts the above technical solution to prevent foreign objects from entering the channel. In addition, after the amniotic fluid is released, the cover can be rotated to close the inlet of the catheter, thus sealing the rupture and preventing a rapid change in amniotic cavity pressure.

[0030] 3. The multifunctional device for amniocentesis, amniotic fluid collection, amniocentesis occlusion, and labor induction provided by the present invention further includes: a first guidewire, the inner end of which is connected to the cover near the rotating end, the outer end of which passes through the wall of the catheter, passes through the channel through the first sac, and extends to the outside; the outer end of the first guidewire is adapted to push and pull to rotate the cover; the present application adopts the above technical solution, and the first guidewire facilitates the opening or closing of the catheter entrance from the outside.

[0031] 4. The multifunctional device for amniocentesis, amniotic fluid collection, amniocentesis occlusion, and labor induction provided by the present invention further includes: a second sac body, suitable for placement in the upper part of the vagina, and suitable for filling with fluid to change its volume for fixed support; the catheter passes through the second sac body; this application adopts the above technical solution, and further improves the stability of the fixed support through the second sac body. In addition, if the first sac body expands too much, it will stimulate uterine contractions and lead to delivery; therefore, when delivery is not required, a small amount of fluid is filled into the first sac body, which only serves as an occlusion function; then the second sac body expands in the upper part of the vagina to serve as a fixation function.

[0032] 5. The multifunctional device for amniocentesis, amniotic fluid collection, amniocentesis occlusion, and labor induction provided by the present invention further includes: a first inflation / deflation component, which passes through a tube through a second sac and is connected to the first sac, and the first inflation / deflation component is adapted to inflate or deflate fluid into the first sac; and a second inflation / deflation component, which is connected to the second sac and is adapted to inflate or deflate fluid into the second sac. The present application adopts the above technical solution, which facilitates the external inflation / deflation of fluid into the first and second sacs, causing the first and second sacs to expand or contract.

[0033] 6. In this invention, both the first and second sacs are balloons; this application adopts the above technical solution to apply a uniform force to the support and fixation points of the first and second sacs to achieve uniform expansion and contraction.

[0034] 7. The present invention coats the top of the first sac with an epidermal growth factor releasing medium; the present application adopts the above technical solution, which can continuously release growth factors through the epidermal growth factor releasing medium to promote rapid healing of the amniotic sac rupture.

[0035] 8. The top of the first sac of the present invention is adapted to abut against the amniotic sac; the present application adopts the above technical solution, the first sac located in the cervix allows the amniotic fluid to be released slowly, avoiding rapid pressure changes; in addition, for pregnant women with premature rupture of membranes, if they have a strong desire to preserve the pregnancy, the first sac can be used to hold the amniotic sac in place, which can temporarily close the amniotic membrane rupture, and at the same time, anti-inflammatory and pregnancy-preserving treatment can be combined to observe the efficacy and increase the chances of successful pregnancy preservation.

[0036] 9. The multifunctional device for amniocentesis, amniotic fluid collection, amniocentesis occlusion and labor induction provided by the present invention further includes: a second guidewire, the inner end of which is connected to the puncture needle, and the outer end of the second guidewire passing through the first sac through a channel and extending to the outside; the outer end of the second guidewire is adapted to push and pull to extend and retract the puncture needle; the present application adopts the above technical solution, and the second guidewire facilitates the extension and retraction of the puncture needle from the outside.

[0037] 10. The multifunctional device for amniocentesis, amniotic fluid collection, amniocentesis occlusion, and labor induction provided by the present invention further includes: a protective shell, fixedly disposed between the first sac and the catheter, wherein the puncture needle and part of the second guidewire are sleeved within the protective shell; a baffle, fixedly disposed within the protective shell; a through hole provided on the baffle; the second guidewire passing through the through hole; a limiting structure provided on the second guidewire on the side of the baffle near the puncture needle, the limiting structure being adapted to prevent part of the second guidewire connected to the puncture needle from detaching from the protective shell; the present application adopts the above technical solution, through the protective shell, the puncture needle is guided to prevent the puncture needle from puncturing the first sac and the cervix; in addition, the limiting structure prevents the puncture needle and the second guidewire from detaching from the protective shell. Attached Figure Description

[0038] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0039] Figure 1 This is a schematic diagram of the connection structure of the multifunctional device for amniocentesis, amniotic fluid collection, amniocentesis occlusion and labor induction provided in the embodiments of the present invention.

[0040] Figure 2 for Figure 1 A magnified schematic diagram of the structure at point A in the middle.

[0041] Explanation of reference numerals in the attached figures:

[0042] 1. First capsule; 2. Second capsule; 3. First inflation / deflation assembly; 4. Second inflation / deflation assembly; 5. First guidewire; 6. Second guidewire; 7. Puncture needle; 8. Cap; 9. Catheter; 10. Collector; 11. Channel; 12. Rotary shaft; 13. Protective shell; 14. Baffle; 15. Limiting structure. Detailed Implementation

[0043] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0044] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0045] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0046] Furthermore, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0047] like Figures 1 to 2 A specific embodiment of the multifunctional device for amniocentesis, amniotic fluid collection, amniotic sac occlusion, and labor induction, as shown, includes: a first sac body 1 and a first inflation / deflation assembly 3 connected together; a second guidewire 6 and a puncture needle 7 connected together; a catheter 9 and a collector 10 connected together; a cover 8 and a first guidewire 5 connected together; a second sac body 2 and a second inflation / deflation assembly 4 connected together; a protective shell 13 sleeved over the puncture needle 7 and part of the second guidewire 6; and a baffle 14 fixedly disposed within the protective shell 13. Specifically, the puncture needle 7 is a fine needle.

[0048] like Figure 1As shown, the first sac 1 is adapted to be placed inside the cervix via the vagina, and is adapted to be filled with fluid to change its volume, thereby supporting the amniotic sac and sealing any rupture. Specifically, fluid is filled into the first sac 1 to increase its volume, allowing it to contact the amniotic sac and provide support. The catheter 9 is located within a channel 11 on the first sac 1, the channel 11 having a very small aperture to minimize amniotic fluid leakage. The collector 10 is connected to the catheter 9 and is adapted to store the amniotic fluid flowing in through the catheter 9. The second sac 2 is adapted to be placed at the upper end of the vagina, and is adapted to be filled with fluid to change its volume, thereby providing fixed support. The catheter 9 passes through the second sac 2. The first filling and discharging assembly 3 passes through the second sac 2 via a conduit and is connected to the first sac 1, and is adapted to fill the first sac 1 with fluid. The second filling and discharging assembly 4 is connected to the second sac 2 and is adapted to fill the second sac 2 with fluid. Specifically, the fluid is a liquid. When the technical solution of this application is used for labor induction, 45 ml of liquid can be injected into the first capsule 1; when the technical solution of this application is used for amniotic sac occlusion, 5 ml of liquid can be injected into the first capsule 1. The first filling and discharging assembly 3 and the second filling and discharging assembly 4 are both connected syringes and valves, and the valves can be three-way valves; the collector 10 is a collection bag. Further, the first capsule 1 and the second capsule 2 are both balloons. The top of the first capsule 1 is coated with an epidermal growth factor release medium. The top of the first capsule 1 is adapted to abut against the amniotic sac. Further, the top of the cover 8 is also coated with an epidermal growth factor release medium. A valve is also provided between the collector 10 and the catheter 9; when the valve is closed, it prevents amniotic fluid from flowing out, thus playing a occlusion role. The outer ends of the first guidewire 5 and the second guidewire 6 extend 3-5 cm outside the vagina.

[0049] like Figure 2As shown, the puncture needle 7 is located within the channel 11 provided on the first sac 1; the puncture needle 7 is adapted to extend and puncture the amniotic sac, allowing amniotic fluid in the amniotic sac to flow into the catheter 9. The cover 8 is rotatably connected to one end of the channel 11 near the amniotic sac via a rotating shaft 12. Specifically, the rotating shaft 12 can be positioned at the junction of the catheter 9 and the channel 11. The cover 8 is adapted to rotate to close or open the entrance of the catheter 9; when the cover 8 closes the entrance of the catheter 9, the cover 8 contacts the amniotic sac. The inner end of the first guidewire 5 is connected to the cover 8 near the rotating end. In cross-section, the inner walls of the first guidewire 5, the cover 8, and the channel 11 are similar to a triangular shape. The first guidewire 5 provides stable support for the cover 8, allowing for stable rotation of the cover 8. The outer end of the first guidewire 5 passes through the wall of the catheter 9, through the channel 11, through the first sac 1 and the second sac 2, and extends to the outside; the outer end of the first guidewire 5 is adapted to push and pull to rotate the cover 8. Specifically, when the outer end of the first guidewire 5 is pushed, the cover 8 rotates to close the inlet of the catheter 9; when the outer end of the first guidewire 5 is pulled, the cover 8 rotates to open the inlet of the catheter 9. The inner end of the second guidewire 6 is connected to the puncture needle 7, and the outer end of the second guidewire 6 passes through the channel 11 through the first capsule 1 and the second capsule 2, extending to the outside; the outer end of the second guidewire 6 is adapted to be pushed and pulled to extend and retract the puncture needle 7. The protective shell 13 is fixedly disposed between the first capsule 1 and the catheter 9, or the protective shell 13 may be glued and fixed to the first capsule 1 and the catheter 9; and the puncture needle 7 and part of the second guidewire 6 are both sleeved inside the protective shell 13; specifically, the protective shell 13 may be a round tube. Furthermore, a through hole is provided on the baffle 14; the second guide wire 6 passes through the through hole; a limiting structure 15 is provided on the second guide wire 6 on the side of the baffle 14 near the puncture needle 7, the limiting structure 15 is adapted to prevent the part of the second guide wire 6 connected to the puncture needle 7 from coming out of the protective shell 13, and also prevents the puncture needle 7 from coming out of the protective shell 13; specifically, the limiting structure 15 can be a spherical protrusion. Sealing is provided at the position near the protective shell 13 at the top of the channel 11, and at the position adjacent to the catheter 9 at the top of the channel 11, to prevent amniotic fluid leakage; thereby collecting more amniotic fluid. Epidermal growth factor release medium can also be coated on the outside of the seal. A structure similar to the channel 11 is also provided at the corresponding positions of the first guide wire 5, the second guide wire 6, the catheter 9, and the tubing connecting the first capsule 1 and the first inflation / deflation assembly 3 when passing through the second capsule 2.

[0050] The main working process of the multifunctional device for amniocentesis, amniotic fluid collection, amniotic sac closure, and labor induction described in this application is briefly described as follows: The puncture needle 7 is inserted through the vagina and cervix to puncture the amniotic sac and release amniotic fluid. At the same time, the first sac 1 in the cervix allows the amniotic fluid to be released slowly, avoiding rapid pressure changes. It can also collect amniotic fluid for precise measurement. When it is necessary to stop releasing amniotic fluid, the puncture needle 7 can be retracted. The first sac 1 can support the amniotic sac and close the rupture.

[0051] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A multifunctional device for amniocentesis, amniotic fluid collection, amniocentesis occlusion, and labor induction, characterized in that, include: The first sac (1) is suitable for placement in the cervix via the vagina, and is suitable for filling the first sac (1) with fluid to change its volume in order to support the amniotic sac. The top of the first sac (1) is coated with an epidermal growth factor release medium. The catheter (9) is located in the channel (11) provided on the first capsule (1); A puncture needle (7) is located within the channel (11); the puncture needle (7) is adapted to extend and puncture the amniotic sac, allowing the amniotic fluid in the amniotic sac to flow into the catheter (9); A collector (10) is connected to a catheter (9) and the collector (10) is adapted to store amniotic fluid flowing into the catheter (9); The cover (8) is rotatably connected to one end of the channel (11) near the amniotic sac. The cover (8) is adapted to rotate to close or open the entrance of the duct (9). When the cover (8) closes the entrance of the duct (9), the cover (8) is in contact with the amniotic sac. The top of the cover (8) is coated with the epidermal growth factor release medium. The inner end of the first guidewire (5) is connected to the cover (8) near the rotating end. The outer end of the first guidewire (5) passes through the wall of the catheter (9), passes through the channel (11) through the first capsule (1), and extends to the outside. The outer end of the first guidewire (5) is adapted to push and pull to rotate the cover (8).

2. The multifunctional device for amniocentesis, amniotic fluid collection, amniocentesis occlusion, and labor induction according to claim 1, characterized in that, Also includes: The second capsule (2) is adapted to be placed at the upper end of the vagina and is adapted to be filled with fluid to change its volume for fixed support; the catheter (9) passes through the second capsule (2).

3. The multifunctional device for amniocentesis, amniotic fluid collection, amniocentesis occlusion, and labor induction according to claim 2, characterized in that, Also includes: The first filling and discharging assembly (3) passes through the second bladder (2) and is connected to the first bladder (1) via a pipeline. The first filling and discharging assembly (3) is adapted to fill and discharge fluid into the first bladder (1). The second filling and discharging assembly (4) is connected to the second capsule (2) and is adapted to fill and discharge fluid into the second capsule (2).

4. The multifunctional device for amniocentesis, amniotic fluid collection, amniocentesis occlusion, and labor induction according to claim 2, characterized in that, Both the first sac (1) and the second sac (2) are balloons.

5. The multifunctional device for amniocentesis, amniotic fluid collection, amniocentesis occlusion, and labor induction according to claim 1, characterized in that, The top of the first capsule (1) is coated with an epidermal growth factor release medium.

6. The multifunctional device for amniocentesis, amniotic fluid collection, amniocentesis occlusion, and labor induction according to claim 1, characterized in that, The top of the first sac (1) is adapted to abut against the amniotic sac.

7. The multifunctional device for amniocentesis, amniotic fluid collection, amniocentesis occlusion, and labor induction according to claim 1, characterized in that, Also includes: The second guidewire (6) has its inner end connected to the puncture needle (7), and its outer end passes through the channel (11) through the first capsule (1) and extends to the outside. The outer end of the second guidewire (6) is adapted to push and pull to extend and retract the puncture needle (7).

8. The multifunctional device for amniocentesis, amniotic fluid collection, amniocentesis occlusion, and labor induction according to claim 7, characterized in that, Also includes: A protective shell (13) is fixedly disposed between the first capsule (1) and the catheter (9), and the puncture needle (7) and part of the second guidewire (6) are both sleeved inside the protective shell (13); A baffle (14) is fixedly disposed inside the protective shell (13); a through hole is provided on the baffle (14); the second guide wire (6) is disposed through the through hole; a limiting structure (15) is provided on the second guide wire (6) on the side of the baffle (14) near the puncture needle (7), the limiting structure (15) is adapted to prevent the part of the second guide wire (6) connected to the puncture needle (7) from coming out of the protective shell (13).

Images