A device and method for treating a neonatal omphalocele

Abstract

The application discloses a new-born umbilical protrusion treatment device and method, relates to the technical field of medical devices, and comprises a ring-shaped fixing seat and a first component, wherein the first component comprises a fan beam for adapting to different protrusion sizes and adjusting the surrounding diameter, and the fan beam is rotationally connected with the ring-shaped fixing seat; through the setting of the first component, the precise adjustment of the surrounding diameter is realized through the cooperation of the fan beam and multiple components such as the engaging body, flexible adjustment and rapid locking, and the device is suitable for different specifications of small to large umbilical protrusion cases; meanwhile, the side wing fixing belt is designed by using elastic cloth and magic tape, the tightness can be flexibly adjusted according to the body type of the new-born, and it is ensured that the ring-shaped fixing seat is always attached to the skin and does not affect the respiratory movement during the treatment process; the multi-dimensional adaptive design solves the problem that the size of the traditional device is fixed and it is difficult to adapt to individual differences, and meets the treatment requirements of different new-born umbilical morphologies and changes in the disease.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a treatment device and method for neonatal umbilical cord prolapse. Background Technology

[0002] Omphalocele, a common congenital abdominal wall malformation, is mainly caused by incomplete closure of the abdominal wall tissue at the umbilicus during embryonic development. This leads to the protrusion of organs such as the intestines and liver through the umbilical defect, covered by a thin sac membrane composed of peritoneum and amnion. This condition has a high incidence in newborns and seriously threatens their lives. If effective treatment is not administered promptly, the sac membrane is prone to rupture, leading to serious complications such as abdominal infection and organ damage, and even neonatal death. In clinical practice, non-surgical conservative treatment is widely used for small omphaloceles and omphalocele in premature infants due to its minimal invasiveness and rapid recovery. The core principle is to apply continuous and controllable pressure to the protruding site, gradually returning the abdominal contents back into the abdominal cavity while stimulating the growth and repair of tissues at the abdominal wall defect, laying a good foundation for subsequent treatment.

[0003] With the continuous improvement of medical standards, the performance requirements for omphalocele treatment devices in clinical practice are becoming increasingly stringent. An ideal treatment device not only needs to be able to transmit pressure accurately and stably to ensure the efficient return of abdominal contents, but also needs to have good individual adaptability to accommodate the differences in umbilical morphology and bulge size among different newborns. At the same time, ease of operation and safety of use are also key clinical concerns. The device should avoid damage to the fragile sac and surrounding skin during dressing changes, adjustments, and other operations, and should provide reliable protection for the sac to reduce the risk of sac rupture caused by external factors. However, current clinically used treatment devices have significant shortcomings in several key performance aspects: In terms of pressure control, most use a single-density material to apply uniform pressure, which cannot match the tension differences in different parts of the omphalocele, easily leading to problems such as excessive local pressure causing ischemia or insufficient pressure affecting treatment efficacy; in terms of adaptability, the fixed base size is fixed and difficult to adjust flexibly according to the size of the omphalocele, and the fixation strap design lacks elastic adjustment function, failing to adapt to changes in the newborn's body shape and respiratory movements, easily leading to device displacement or skin compression; the assembly and disassembly structure design is unreasonable, requiring complete removal of the device during dressing changes, which can easily cause traction damage to the omphalocele and surrounding skin; protective measures are inadequate, lacking a dedicated physical protective structure, making the omphalocele susceptible to damage from external friction and impact; the operation procedure is cumbersome, relying on the experience of medical staff, and prone to operational errors.

[0004] Therefore, this invention proposes a treatment device for neonatal umbilical prolapse to solve the above problems. Summary of the Invention

[0005] To address the shortcomings of existing technologies, this invention provides a treatment device for neonatal umbilical prolapse, thereby resolving the problems mentioned in the background section.

[0006] To achieve the above objectives, in the first aspect, the present invention provides the following technical solution: a neonatal umbilical prolapse treatment device and method, comprising: an annular fixing seat and a first component, the first component comprising: a fan beam for adjusting the circumferential diameter to adapt to different prolapse sizes, the fan beam being rotatably connected to the annular fixing seat, the fan beam being made of a flexible material, the outer arc surface of the fan beam away from the annular fixing seat being provided with toothed blocks at equal intervals, a cover being fixedly connected to one side of the annular fixing seat, and a groove being formed on the side of the cover away from the annular fixing seat;

[0007] The second component is used for the quick assembly and disassembly of multiple parts.

[0008] Preferably, the annular fixation seat consists of an annular body and a rectangular body protruding on one side. The annular fixation seat is made of medical-grade silicone material. The inner side of the annular fixation seat has an arc-shaped curved surface, the radius of which is adapted to the physiological curvature of the skin around the umbilicus of the newborn. A compression body is provided above the annular fixation seat, and a cover is provided around the outer ring of the compression body. The cover is semi-circular and made of transparent medical-grade polycarbonate material. A side wing fixing strap is fixedly connected to the bottom of the annular fixation seat.

[0009] Preferably, the first component further includes: a shaped groove fixedly connected to the annular fixed seat, a meshing body engaged with the outer ring tooth block of the fan beam, one end of the meshing body being rotatably connected to the annular fixed seat, a rectangular protrusion provided at one end of the meshing body, the side of the meshing body near the rectangular protrusion being fitted and engaged with the shaped groove, and an arc groove being provided in the middle of the side of the meshing body away from the fan beam.

[0010] Preferably, a functional body is provided on the side of the meshing body away from the fan beam. The functional body is slidably connected to the annular fixed seat. A rectangular groove is formed on the side of the functional body near the meshing body. A through groove is formed in the middle of the functional body. A control body is slidably connected in the through groove. An abutment body is fixedly connected on the side of the functional body near the meshing body. An actuating member is rotatably connected to the annular fixed seat on one side of the functional body. The end of the actuating member away from the annular fixed seat is slidably connected in the actuating groove. A limiting member is provided on the side of the actuating member near the meshing body. The limiting member is fixedly connected to the annular fixed seat.

[0011] Preferably, the rectangular groove and the rectangular protrusion of the meshing body are on the same axis. The control body is composed of a positioning post and a spring. The positioning post in the control body is fixedly connected to the annular fixed seat, and the two ends of the spring are respectively connected to the functional body and the positioning post. There is an elastic force between the abutting body and the functional body. One end of the abutting body is set as an arc surface and abuts against the arc groove.

[0012] Preferably, the second component includes: ear seats fixedly connected to both sides of the annular fixing seat, a base fixedly connected to the ear seats, the bases being synchronously and symmetrically arranged on the annular fixing seat, an outer shell being provided on the base, a connector being fixedly connected to the side of the outer shell near the annular fixing seat, the end of the connector away from the base being fixedly connected to the cover, a middle shell being slidably connected inside the outer shell, and an abutment ring being fixedly connected to the outer ring of the middle shell near the base, the abutment ring being in contact with the base.

[0013] Preferably, a fan-shaped cavity is formed at one end of the middle shell near the base, and the fan-shaped cavity is connected to the inner cavity of the middle shell. A driving component is slidably connected inside the middle shell. The driving component consists of an electrically controlled telescopic rod and an auxiliary column. An auxiliary component is rotatably connected to one end of the driving component near the base. A limiting cavity is formed in the middle of the auxiliary component. A positioning triangle is rotatably connected inside the limiting cavity. The other triangular end of the positioning triangle is rotatably connected to the fan-shaped cavity. The end of the positioning triangle away from the auxiliary component abuts against the top surface of the inner cavity of the base.

[0014] Secondly, the present invention provides the following technical solution: a treatment method for neonatal omphalocele, comprising the following steps:

[0015] Step 1: Select an appropriate size ring-shaped fixing seat according to the size of the umbilical prolapse, ensuring that the adjustment range can cover the diameter of the prolapsed base, and select a compression body of the corresponding size;

[0016] Prepare the disinfected mask, side wing fixing straps, and related auxiliary tools, including various materials such as sterile saline, medical iodine, and sterile gauze;

[0017] Step 2: Unfold the annular fixing seat. The fan beam in the first component engages with the meshing body. Initially, the inner diameter of the annular fixing seat is larger than the diameter of the bulging base. Place the annular fixing seat around the umbilical cord to ensure that the inner arc surface completely fits the skin and the edges are not raised. Subsequently, push the fan beam into the annular fixing seat according to the needs of the umbilical bulging and adjust the bottom fitting diameter of the annular fixing seat.

[0018] Wrap the side wing fixing strap around the newborn's abdomen, adjust the tightness to allow for a finger gap, and secure it with Velcro fasteners to ensure that the ring fixing seat does not shift and does not affect the newborn's breathing;

[0019] Step 3: With the high-density foam layer of the compression body facing the surface of the capsule, press slowly and work in conjunction with the second component until the positioning triangle locks with the base. At this point, the compression body will gently contact the surface of the capsule.

[0020] Install the cover, align and fasten the outer shell with the base, and check that the cover completely includes the compressed body and surrounding skin to ensure there are no gaps.

[0021] Step 4: During dressing change, control the contraction of the drive unit, remove the cover, remove the compression body, and gently clean the surface of the capsule and surrounding skin with sterile saline to remove secretions and scabs.

[0022] Check the integrity of the capsule. If there is any damage or infection, apply medical antibacterial ointment, cover with sterile gauze, replace with a new compression body, adjust the pressure to the original parameters, and reinstall the capsule.

[0023] Step 5: The abdominal contents are completely returned to normal, the bulge disappears, the skin around the navel basically returns to its normal shape, and ultrasound examination shows that the abdominal cavity volume has returned to normal, the position of the abdominal organs is normal, and there are no obvious signs of intra-abdominal hypertension.

[0024] Gradually reduce the pressure until it drops to the initial level, then completely remove the compressor and the annular fixing seat.

[0025] Remove the side fixation band, clean the umbilical skin, observe for 24 hours without any abnormalities, and then wear a sterile umbilical brace to protect the wound.

[0026] Compared with the prior art, the present invention provides a device and method for treating neonatal omphalocele, which has the following beneficial effects:

[0027] 1. Through the design of the first component, and with the coordinated operation of multiple parts such as the fan beam and the meshing body, the circumferential diameter can be precisely adjusted through flexible adjustment and quick locking, adapting to omphalocele cases of different sizes from small to large. At the same time, the side fixation straps adopt an elastic fabric and Velcro design, which can flexibly adjust the tightness according to the newborn's body shape, ensuring that the ring fixation seat always fits the skin during treatment and does not affect breathing. This multi-dimensional adaptation design solves the problem of fixed size and difficulty in adapting to individual differences of traditional devices, meeting the treatment needs of different newborn umbilical morphology and changes in condition.

[0028] 2. Through the design of the compression body, the three-layer gradient density foam structure achieves scientific pressure transmission to the omphalocele site; the high-density foam layer directly acts on the surface of the sac to provide core compression force, the medium-density foam layer achieves a smooth pressure transition, and the low-density foam layer uniformly transmits pressure and buffers vibration. The three layers work together to form a gradient pressure field. This design avoids the problem of uneven pressure distribution in traditional single-density materials. It can apply effective pressure to the bulging center to promote the rapid return of abdominal contents, and reduce the risk of sac ischemia caused by excessive local pressure through the pressure gradient. It significantly improves the efficiency and safety of non-surgical conservative treatment and accelerates the repair process of neonatal umbilical tissue.

[0029] 3. With the second component, the connectors on both sides of the component only need to be aligned perpendicularly with the base. After the outer ring of the outer shell is in contact with the base, the external controller can be used to extend the drive component, which will cause the positioning triangle to deflect and contact the top of the inner cavity of the card holder to complete the fixation. The whole process does not require complicated operation steps. When disassembling, simply control the drive component to retract, and the positioning triangle will deflect in the opposite direction to release the contact, so that the component can be easily lifted out of the ring fixing seat. This assembly and disassembly method greatly shortens the operation time of device installation and dressing change, and significantly improves the efficiency of clinical treatment. Moreover, it avoids the traction damage to the fragile capsule and surrounding skin when the traditional device is completely removed during dressing change, reduces the operation risk during dressing change, simplifies the operation process of medical staff, reduces the dependence on operation experience, and improves the standardization of the treatment process.

[0030] 4. The diaphragm is made of medical-grade polycarbonate material, which effectively protects the umbilical cord from external friction and impact through physical barrier, reducing the risk of rupture. Its transparency allows medical staff to easily observe changes in the cord's color, blood supply, and bulging, enabling daily monitoring without removing the device. The ring-shaped fixation base is made of medical-grade silicone, with an inner curved surface that conforms to the physiological curvature of the newborn's skin, reducing skin pressure damage. The side fixation straps are made of breathable, elastic fabric to prevent skin stuffiness and discomfort. This multi-layered protective design creates a safe and stable treatment environment for the newborn's umbilical cord, significantly reducing the risk of complications during treatment. Attached Figure Description

[0031] Figure 1 This is a schematic diagram of the overall structure of the present invention;

[0032] Figure 2 This is a schematic diagram of the overall structure of the invention from another perspective;

[0033] Figure 3 This is a disassembled structural diagram of the present invention;

[0034] Figure 4 This is a partial top view of the structure of the present invention;

[0035] Figure 5 This is a partial structural diagram of the first component of the present invention;

[0036] Figure 6 This is a disassembled structural diagram of the first component of the present invention;

[0037] Figure 7 For the present invention Figure 6 Enlarged structural diagram at point A in the middle;

[0038] Figure 8 This is a cross-sectional view of the second component of the present invention;

[0039] Figure 9This is a partial structural diagram of the second component of the present invention;

[0040] Figure 10 This is a disassembled structural diagram of the second component of the present invention;

[0041] Figure 11 This is a partial disassembly diagram of the second component of the present invention.

[0042] In the picture:

[0043] 11. Annular fixing seat; 12. Compression body; 13. Cover; 14. Side wing fixing strap;

[0044] 21. Fan beam; 22. Cover; 23. Slot; 24. Irregular groove; 25. Meshing body; 26. Arc groove; 27. Functional body; 28. Rectangular groove; 29. ​​Through groove; 210. Control body; 211. Abutting body; 212. Actuating element; 213. Limiting element;

[0045] 31. Ear base; 32. Base; 33. Connector; 34. Outer shell; 35. Middle shell; 36. Contact ring; 37. Sector cavity; 38. Drive unit; 39. Auxiliary component; 310. Limiting cavity; 311. Positioning triangle. Detailed Implementation

[0046] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. 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.

[0047] The present invention will now be described in further detail with reference to the accompanying drawings and embodiments.

[0048] Example

[0049] Please refer to Figures 1 to 7 As shown:

[0050] To address the problems mentioned in the technical solutions, this application provides a neonatal umbilical cord prolapse treatment device, comprising: an annular fixing seat 11 and a first component. The first component includes: a fan beam 21 for adjusting the circumferential diameter to accommodate different prolapse sizes. The fan beam 21 is rotatably connected to the annular fixing seat 11. The fan beam 21 is made of a flexible material. Tooth blocks are equidistantly arranged on the outer arc surface of the connecting end of the fan beam 21 away from the annular fixing seat 11. A cover 22 is fixedly connected to one side of the annular fixing seat 11. A groove 23 is provided on the side of the cover 22 away from the annular fixing seat 11.

[0051] The second component is used for the quick assembly and disassembly of multiple parts.

[0052] The annular fixation base 11 consists of an annular body and a rectangular body protruding on one side. The annular fixation base 11 is made of medical-grade silicone. The inner side of the annular fixation base 11 has an arc-shaped curved surface, the radius of which is adapted to the physiological curvature of the skin around the umbilicus of the newborn. A compression body 12 is provided above the annular fixation base 11. The compression body 12 is composed of a three-layer foam substrate with gradually increasing gradient density. The first layer is high-density foam, which directly acts on the surface of the umbilical prolapse membrane. The second layer is medium-density foam, located below the high-density foam. The third layer is low-density foam, which serves as the base of the compression body 12 and is attached to and connected to the compression body 12. Next, the compression body 12 is used to apply gradient pressure to the umbilical prolapse area. Both the compression body 12 and the cover 13 can be quickly assembled and disassembled with the annular fixing seat 11 through the second component. The cover 13 is provided on the outer ring of the compression body 12. The cover 13 is semi-circular and made of transparent medical-grade polycarbonate material. A side wing fixing strap 14 is fixedly connected below the annular fixing seat 11. The side wing fixing strap 14 is made of breathable medical elastic fabric and has a Velcro fastener at one end. The surface and the rough side of the Velcro fastener are sewn to the front and back of the side wing fixing strap 14 respectively. The side wing fixing strap 14 is used to wrap around the newborn to fix the whole device.

[0053] The first component also includes: a shaped groove 24 fixedly connected to the annular fixed seat 11; a meshing body 25 engaged with the outer ring tooth block of the fan beam 21; one end of the meshing body 25 being rotatably connected to the annular fixed seat 11; a rectangular protrusion provided at one end of the meshing body 25; the side of the meshing body 25 near the rectangular protrusion being fitted and engaged with the shaped groove 24; and an arc groove 26 being provided in the middle of the side of the meshing body 25 away from the fan beam 21.

[0054] A functional body 27 is provided on the side of the meshing body 25 away from the fan beam 21. The functional body 27 is slidably connected to the annular fixed seat 11. A rectangular groove 28 is provided on the side of the functional body 27 near the meshing body 25. A through groove 29 is provided in the middle of the functional body 27. A control body 210 is slidably connected in the through groove 29. An abutment body 211 is fixedly connected on the side of the functional body 27 near the meshing body 25. A toggle member 212 is rotatably connected on the annular fixed seat 11 on one side of the functional body 27. The end of the toggle member 212 away from the annular fixed seat 11 is slidably connected in the toggle groove 23. A limit member 213 is provided on the side of the toggle member 212 near the meshing body 25. The limit member 213 is fixedly connected to the annular fixed seat 11.

[0055] The rectangular groove 28 and the rectangular protrusion of the meshing body 25 are on the same axis. The control body 210 consists of a positioning post and a spring. The positioning post in the control body 210 is fixedly connected to the annular fixing seat 11, and the two ends of the spring are respectively connected to the functional body 27 and the positioning post. There is an elastic force between the contact body 211 and the functional body 27. One end of the contact body 211 is set as an arc surface and abuts against the arc groove 26.

[0056] A further embodiment: Please refer to Figures 8 to 11 As shown:

[0057] The second component includes: ear seats 31 fixedly connected to both sides of the annular fixing seat 11, a base 32 fixedly connected to the ear seats 31, the base 32 being synchronously and symmetrically arranged on the annular fixing seat 11, an outer shell 34 being provided on the base 32, a connector 33 being fixedly connected to the side of the outer shell 34 near the annular fixing seat 11, the end of the connector 33 away from the base 32 being fixedly connected to the cover 13, connectors 33 being provided on both sides of the compression body 12 and connected to the second component, a middle shell 35 being slidably connected inside the outer shell 34, an abutment ring 36 being fixedly connected to the outer ring of the middle shell 35 near the base 32, and the abutment ring 36 being in contact with the base 32.

[0058] A sector-shaped cavity 37 is provided at one end of the middle shell 35 near the base 32. The sector-shaped cavity 37 is connected to the inner cavity of the middle shell 35. A driving component 38 is slidably connected inside the middle shell 35. The driving component 38 is controlled by an external controller. The driving component 38 consists of an electrically controlled telescopic rod and an auxiliary column. An auxiliary component 39 is rotatably connected inside the end of the driving component 38 near the base 32. A limiting cavity 310 is provided in the middle of the auxiliary component 39. A positioning triangle 311 is rotatably connected inside the limiting cavity 310. The other triangular end of the positioning triangle 311 is rotatably connected inside the sector-shaped cavity 37. The end of the positioning triangle 311 away from the auxiliary component 39 abuts against the top surface of the inner cavity of the base 32.

[0059] The specific treatment methods for neonatal omphalocele are as follows:

[0060] Step 1: Select an annular fixing seat 11 of appropriate size according to the size of the umbilical prolapse, ensuring that the adjustment range can cover the diameter of the prolapsed base, and select a compression body 12 of the corresponding size.

[0061] Prepare the disinfected cover 13, side wing fixing straps 14 and related auxiliary tools, including sterile saline, medical iodine, sterile gauze and other materials;

[0062] Step 2: Unfold the annular fixing seat 11. The fan beam 21 in the first component engages with the meshing body 25. Initially, the inner diameter of the annular fixing seat 11 is larger than the diameter of the bulging base. Place the annular fixing seat 11 around the umbilical cord to ensure that the inner arc-shaped surface completely fits the skin and the edges are not raised. Subsequently, push the fan beam 21 into the annular fixing seat 11 according to the needs of umbilical bulging and adjust the bottom fitting diameter of the annular fixing seat 11.

[0063] Wrap the side wing fixing strap 14 around the newborn's abdomen, adjust the tightness to allow for a finger gap, and fix it with Velcro fasteners to ensure that the ring fixing seat 11 does not shift and does not affect the newborn's breathing.

[0064] Step 3: With the high-density foam layer of the compression body 12 facing the surface of the capsule, press slowly and use it in conjunction with the second component until the positioning triangle 311 and the base 32 are locked. At this time, the compression body 12 will gently contact the surface of the capsule.

[0065] Install the cover 13, align and fasten the outer shell 34 with the base 32, and check whether the coverage area of ​​the cover 13 completely includes the compression body 12 and the surrounding skin to ensure there are no gaps.

[0066] Step 4: During dressing change, control the retraction of drive component 38, remove cover 13, remove compression body 12, and gently clean the surface of the capsule and surrounding skin with sterile saline to remove secretions and scabs.

[0067] Check the integrity of the capsule. If there is any damage or infection, apply medical antibacterial ointment, cover with sterile gauze, replace with a new compression body 12, adjust the pressure to the original parameters, and reinstall the cover 13.

[0068] Step 5: The abdominal contents are completely returned to normal, the bulge disappears, the skin around the navel basically returns to its normal shape, and ultrasound examination shows that the abdominal cavity volume has returned to normal, the position of the abdominal organs is normal, and there are no obvious signs of intra-abdominal hypertension.

[0069] Gradually reduce the pressure until it drops to the initial level, then completely remove the compressor 12 and the annular fixed seat 11.

[0070] Remove the lateral fixation band 14, clean the umbilical skin, observe for 24 hours without any abnormalities, and then wear a sterile umbilical brace to protect the wound.

[0071] The working principle of all the content in the above embodiments is as follows:

[0072] The following is the working process of the first component:

[0073] When using it, before treating neonatal omphalocele, place the ring fixation seat 11 on the skin around the neonatal omphalocele, ensuring that the inner arc-shaped surface is completely in contact with the skin around the navel. Wrap the side fixation straps 14 around the neonatal abdomen from both sides to the opposite side. Control the tightness of the fixation straps by adjusting the position of the Velcro fasteners. The ring fixation seat 11 should not shift and should not affect the neonatal breathing. This completes the fixation of the ring fixation seat 11.

[0074] Then, the annular fixing seat 11 is adjusted according to the actual size of the umbilical bulge, pushing the fan beam 21 to move towards the center of the annular fixing seat 11. The outer ring of the toothed block engages with the meshing body 25. Since the direction of the toothed block is the same as the offset direction of the fan beam 21, the diameter of the annular fixing seat 11 is reduced. When the appropriate diameter is adjusted, the fan beam 21 abuts against the meshing body 25 and moves towards the functional body 27. This abutting force pushes the abutting body 211 to deflect in the opposite direction with the connection point of the functional body 27 as the axis. The rectangular block on the meshing body 25 is engaged in the rectangular groove 28 to assist the displacement redundancy of the meshing body 25. Under this operation, the meshing body 25 deflects with the connection point of the annular fixing seat 11 as the axis, realizing the gradual engagement of the fan beam 21 and the meshing body 25. When the fan beam 21 abuts against the meshing body 25, the abutting body 211 and the meshing body 25 abut against each other, causing the abutting body 211 to reset after being pressed by the fan beam 21, strengthening the engagement between the meshing body 25 and the fan beam 25. After the meshing connection of beam 21 is adjusted, the actuating element 212 is reversed and deflected in the opposite direction around the connection of the annular fixed seat 11, so that one end of it deflects towards the functional body 27, pushing the functional body 27 to slide away from the actuating element 212 on the annular fixed seat 11. The control body 210 is fixed to the annular fixed seat 11 and provides linear guidance for the movement of the functional body 27. The spring in the control body 210 is compressed to store elastic potential energy to assist the subsequent reset of the functional body 27. Under the displacement of the functional body 27, the front arc surface of the contact body 211 engages with the arc groove 26. The side of the functional body 27 near the meshing body 25 abuts against the rectangular block at the upper end of the meshing body 25 to prevent further deflection of the meshing body 25 and fix the deflection angle of the meshing body 25, thereby achieving the meshing stability of the meshing body 25 and the fan beam 21, thus completing the diameter adjustment.

[0075] Through the design of the first component, the fan beam 21 and the meshing body 25, along with other components, achieve precise adjustment of the circumferential diameter through flexible adjustment and quick locking, adapting to omphalocele cases of different sizes from small to large. At the same time, the side fixation strap 14 adopts an elastic fabric and Velcro design, which can flexibly adjust the tightness according to the newborn's body shape, ensuring that the ring fixation seat 11 always fits the skin during treatment and does not affect breathing. This multi-dimensional adaptation design solves the problem of fixed size and difficulty in adapting to individual differences in traditional devices, meeting the treatment needs of different newborn umbilical morphologies and changes in condition.

[0076] Please refer to the above work process. Figures 1 to 7 .

[0077] The following is the working process of the second component:

[0078] In use, the compressor 12 is positioned so that the connecting parts 33 on both sides are perpendicular to the base 32 on the annular fixing seat 11. The compressor 12 is then placed vertically on the annular fixing seat 11, directly facing the surface of the umbilical protuberance membrane, providing compression force. As the compressor 12 approaches the annular fixing seat 11, the compressor 12 drives the outer shells 34 on both sides to gradually approach the base 32 until the contact ring 36 on the outer ring of the outer shell 34 is in contact with the base 32. When the lower surface of the contact ring 36 is in contact with the base 32, the drive unit 38 is activated by the external controller to extend, pushing the drive unit 38 towards the base 32. At the same time, the auxiliary parts 39 inside the drive unit 38 extend synchronously. The auxiliary component 39 moves towards the base 32. The movement of the auxiliary component 39 causes one end of the positioning triangle 311, which is movably connected inside it, to slide and deflect. Since the positioning triangle 311 is triangular in shape and its middle part is rotatably connected to the wall of the middle shell 35 in the fan-shaped cavity 37, when the auxiliary component 39 moves and causes one end of the positioning triangle 311 to deflect, under the limitation of the rotational connection between the positioning triangle 311 and the middle shell 35, the end of the positioning triangle 311 away from the auxiliary component 39 deflects upward about the connection between the positioning triangle 311 and the middle shell 35 as the axis until it abuts against the top of the inner cavity of the base 32, thereby realizing the rapid fixation of the compression body 12 and the annular fixing seat 11.

[0079] The installation process of the cover 13 and the annular fixing seat 11 is the same as described above. The connectors 33 on both sides of the cover 13 correspond vertically to the base 32 on the ear seat 31 to complete the quick installation. At the same time, ensure that the cover 13 completely covers the compression body 12 and the skin around the umbilical protrusion, and the edges fit the surface of the annular fixing seat 11.

[0080] Furthermore, during treatment, the high-density foam layer in the compression body 12, which acts directly on the surface of the cyst, provides the main compressive force, applying high pressure to the center of the bulging area through plastic compression; the medium-density foam layer is located in the middle, achieving a smooth transition of pressure and avoiding damage to the cyst from sudden pressure changes; the low-density foam layer serves as a base, uniformly transmitting pressure to the annular fixation seat 11 and buffering external vibrations. The three-layer structure works synergistically to form a gradient pressure field, continuously promoting the return of abdominal contents into the abdominal cavity; the semi-circular transparent cover 13, through the physical properties of medical-grade polycarbonate material, effectively blocks external friction and collisions, preventing cyst rupture. At the same time, its transparency allows medical staff to observe the cyst color, blood supply, and bulging changes at any time, enabling daily monitoring without removing the device;

[0081] During dressing changes, there is no need to remove the annular fixing seat 11 and the side wing fixing straps 14. The control drive 38 retracts, the positioning triangle 311 deflects in the opposite direction, and the contact force against the base 32 is applied. The cover 13 and the compression body 12 are pulled upward to detach them from the annular fixing seat 11, achieving quick disassembly. After cleaning the capsule and surrounding skin and completing the dressing change, the compression body 12 and the protective cover 13 are reinstalled according to the installation steps. If pressure adjustment is required, the compression body 12 can be quickly replaced through the second component, and the fan beam 21 can be adjusted to ensure that the treatment pressure is adapted to changes in the condition.

[0082] With the compression body 12, the three-layer gradient density foam structure achieves scientific pressure transmission to the omphalocele site. The high-density foam layer directly acts on the surface of the sac to provide core compression force, the medium-density foam layer achieves a smooth pressure transition, and the low-density foam layer uniformly transmits pressure and buffers vibration. The three layers work together to form a gradient pressure field. This design avoids the problem of uneven pressure distribution in traditional single-density materials. It can apply effective pressure to the bulge center to promote the rapid return of abdominal contents, and reduce the risk of sac ischemia caused by excessive local pressure through the pressure gradient. It significantly improves the efficiency and safety of non-surgical conservative treatment and accelerates the repair process of neonatal umbilical tissue.

[0083] With the second component, the connecting parts 33 on both sides of the component are aligned perpendicularly with the base 32. After the contact ring 36 on the outer ring of the outer shell 34 is in contact with the base 32, the drive component 38 is extended by the external controller, which drives the positioning triangle 311 to deflect and contact the top of the inner cavity of the card holder to complete the fixation. The whole process does not require complicated operation steps. When disassembling, the drive component 38 is retracted and the positioning triangle 311 deflects in the opposite direction to release the contact, so that the component can be easily lifted out of the annular fixing seat 11. This assembly and disassembly method greatly shortens the operation time of device installation and dressing change, and significantly improves the work efficiency of clinical treatment. Moreover, it avoids the traction damage to the fragile capsule and surrounding skin when the traditional device is completely removed during dressing change, reduces the operation risk during dressing change, simplifies the operation process of medical staff, reduces the dependence on operation experience, and improves the standardization of the treatment process.

[0084] The cover 13 is made of medical-grade polycarbonate material, which effectively protects the umbilical cord from external friction and impact through physical barrier, reducing the risk of umbilical cord rupture. Its transparency also allows medical staff to easily observe changes in the color, blood supply, and bulging of the umbilical cord, enabling daily monitoring without removing the device. The ring-shaped fixation base 11 is made of medical-grade silicone, with an inner curved surface that conforms to the physiological curvature of the newborn's skin, reducing skin pressure damage. The side fixation straps 14 are made of breathable elastic fabric to prevent skin stuffiness and discomfort. This multi-protective design creates a safe and stable treatment environment for the newborn's umbilical cord, significantly reducing the risk of complications during treatment.

[0085] Please refer to the above work process. Figures 8 to 11 .

[0086] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0087] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A treatment device for neonatal omphalocele, comprising: The annular fixing seat (11) and the first component are characterized in that the first component includes: a fan beam (21) for adjusting the circumferential diameter to accommodate different bulge sizes, the fan beam (21) being rotatably connected to the annular fixing seat (11), the fan beam (21) being made of flexible material, the outer arc surface of the connecting end of the fan beam (21) away from the annular fixing seat (11) being provided with toothed blocks at equal intervals, a cover (22) being fixedly connected to one side of the annular fixing seat (11), and a groove (23) being provided on the side surface of the cover (22) away from the annular fixing seat (11); the second component is used for quick assembly and disassembly of multiple components; The annular fixing seat (11) consists of an annular body and a rectangular body protruding on one side. The annular fixing seat (11) is made of medical silicone material. The inner side of the annular fixing seat (11) is an arc-shaped curved surface. The radius of the arc-shaped curved surface is adapted to the physiological curvature of the skin around the umbilicus of the newborn. A compression body (12) is provided above the annular fixing seat (11). A cover (13) is provided on the outer ring of the compression body (12). The cover (13) is semi-circular and made of transparent medical-grade polycarbonate material. A side wing fixing strap (14) is fixedly connected to the bottom of the annular fixing seat (11).

2. The neonatal umbilical cord prolapse treatment device according to claim 1, characterized in that: The first component also includes: a shaped groove (24) fixedly connected to the annular fixed seat (11), a meshing body (25) meshing with the outer ring tooth block of the fan beam (21), one end of the meshing body (25) being rotatably connected to the annular fixed seat (11), a rectangular protrusion being provided at one end of the meshing body (25), the side of the meshing body (25) near the rectangular protrusion being fitted and snapped with the shaped groove (24), and an arc groove (26) being provided in the middle of the side of the meshing body (25) away from the fan beam (21).

3. The neonatal umbilical cord prolapse treatment device according to claim 2, characterized in that: The engagement body (25) has a functional body (27) on the side away from the fan beam (21). The functional body (27) is slidably connected to the annular fixed seat (11). The side of the functional body (27) near the engagement body (25) has a rectangular groove (28). The middle of the functional body (27) has a through groove (29). A control body (210) is slidably connected in the through groove (29). A contact body (211) is fixedly connected to the side of the functional body (27) near the engagement body (25). A toggle member (212) is rotatably connected to the annular fixed seat (11) on one side of the functional body (27). The end of the toggle member (212) away from the annular fixed seat (11) is slidably connected in the toggle groove (23). A limit member (213) is provided on the side of the toggle member (212) near the engagement body (25). The limit member (213) is fixedly connected to the annular fixed seat (11).

4. The neonatal umbilical cord prolapse treatment device according to claim 3, characterized in that: The rectangular groove (28) and the rectangular protrusion of the meshing body (25) are on the same axis. The control body (210) is composed of a positioning post and a spring. The positioning post in the control body (210) is fixedly connected to the annular fixing seat (11), and the two ends of the spring are respectively connected to the functional body (27) and the positioning post. There is an elastic force between the contact body (211) and the functional body (27). One end of the contact body (211) is set as an arc surface and abuts against the arc groove (26).

5. A neonatal umbilical cord prolapse treatment device according to claim 1, characterized in that: The second component includes: ear seats (31) fixedly connected to both sides of the annular fixing seat (11), a base (32) fixedly connected to the ear seats (31), the base (32) being synchronously and symmetrically arranged on the annular fixing seat (11), an outer shell (34) being provided on the base (32), a connector (33) being fixedly connected to the side of the outer shell (34) near the annular fixing seat (11), the end of the connector (33) away from the base (32) being fixedly connected to the cover (13), a middle shell (35) being slidably connected inside the outer shell (34), an abutment ring (36) being fixedly connected to the outer ring of the middle shell (35) near the base (32), and the abutment ring (36) being in contact with the base (32).

6. A neonatal umbilical cord prolapse treatment device according to claim 5, characterized in that: The middle shell (35) has a fan-shaped cavity (37) at one end near the base (32). The fan-shaped cavity (37) is connected to the inner cavity of the middle shell (35). A driving member (38) is slidably connected inside the middle shell (35). The driving member (38) consists of an electrically controlled telescopic rod and an auxiliary column. An auxiliary member (39) is rotatably connected inside the end of the driving member (38) near the base (32). A limiting cavity (310) is opened in the middle of the auxiliary member (39). A positioning triangle (311) is rotatably connected inside the limiting cavity (310). The other triangular end of the positioning triangle (311) is rotatably connected inside the fan-shaped cavity (37). The end of the positioning triangle (311) away from the auxiliary member (39) abuts against the top surface of the inner cavity of the base (32).

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