A total pelvic postoperative vsd support drainage integrated device and a preparation method thereof

Abstract

The application belongs to the technical field of medical devices, and mainly provides a full-pelvic postoperative VSD supporting and draining integrated device and a preparation method thereof. The device comprises a main unit, a hollow air bag, a VSD sponge layer, a composite pipe network system, a longitudinal folding guide structure and a multi-cavity integrated pipe cable. The main unit is formed by one-step molding of medical silicone rubber to form an integrated structure of an internal high-density dense layer and an external low-density porous layer. The hollow air bag provides dynamic support after inflation, and the VSD sponge layer conducts negative pressure in adhesion with a wound surface. The composite pipe network system switches between gravity drainage and VSD negative pressure drainage in a double mode, and four rows of 12 pipes are arranged to improve the drainage and flushing coverage range. The longitudinal folding guide structure guides the axial symmetrical folding after air extraction, and is convenient for minimally invasive extraction. The multi-cavity integrated pipe cable simplifies the extracorporeal pipeline. The application integrates support, negative pressure drainage, active flushing and minimally invasive extraction, effectively solves the problems of dead space, uneven drainage and difficult extraction after full-pelvic postoperative surgery, and is suitable for postoperative pelvic floor reconstruction and wound treatment after full-pelvic organ resection.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and in particular relates to an integrated device for VSD support and drainage after full pelvic surgery and its preparation method. Background Technology

[0002] Total pelvic organ resection is an important surgical procedure for treating advanced or recurrent pelvic malignancies. However, it leaves a large dead space in the pelvis after the operation, which can easily lead to complications such as small bowel prolapse, exudate accumulation, infection, anastomotic leakage, and poor wound healing. Therefore, there is an urgent clinical need for reliable pelvic floor support and wound drainage solutions.

[0003] Current clinical methods commonly used include pelvic floor peritoneal suturing, gauze packing, simple drainage tubes, or local negative pressure drainage. These methods generally have the following drawbacks:

[0004] 1. Limited functionality; unable to simultaneously achieve pelvic floor support, full-area negative pressure conduction, and active flushing.

[0005] 2. The pipeline layout is unreasonable, resulting in limited coverage for drainage and flushing, and low efficiency;

[0006] 3. The support volume is fixed and cannot be dynamically adjusted with the healing process, which can easily lead to over- or under-support.

[0007] 4. If the volume is too large when removed, there will be great resistance when removing it through the perineum, which may easily cause tissue damage;

[0008] 5. The drainage mode is inconvenient to switch, and it cannot meet the needs of early gravity drainage and later VSD negative pressure to promote healing.

[0009] 6. Existing VSD drainage devices and pelvic floor support devices are mostly separate structures, which cannot simultaneously achieve dynamic support, full-area drainage and irrigation, and minimally invasive removal, thus limiting their clinical use.

[0010] Therefore, the present invention provides an integrated, dynamically adjustable, longitudinally foldable, and minimally invasively removable VSD support and drainage device for postoperative pelvic cavity drainage. Summary of the Invention

[0011] In view of the shortcomings of the prior art described above, the purpose of this invention is to provide an integrated VSD support and drainage device for postoperative pelvic cavity and its preparation method, which can realize dynamic support of the pelvic floor, full-area negative pressure drainage, distributed active irrigation, free switching of drainage mode and longitudinal folding for minimally invasive removal after aspiration, and solve problems such as postoperative dead space, uneven drainage and difficult removal.

[0012] To achieve the above and other related objectives, the first aspect of the present invention provides an integrated VSD support and drainage device for postoperative pelvic drainage, comprising:

[0013] The main body unit is made of foamed modified medical silicone rubber in one piece. The whole body is a cavity adapted to the anatomical structure of the human pelvis, in the shape of an inverted pear or saddle, with the bottom narrowed to accommodate the perineal outlet. The main body unit has a gradient density structure, which is formed by a continuous change in foaming ratio between an inner high-density dense layer and an outer low-density porous layer, without physical layering interface.

[0014] The air bladder is formed by a high-density, compact layer, which provides physical support to the pelvic floor after inflation, and the internal pressure can be dynamically adjusted.

[0015] VSD sponge layer, which is composed of a low-density porous layer, is wrapped around the outside of the air bladder and has three-dimensional interconnected pores, used to fit the wound surface, conduct negative pressure, collect exudate and disperse irrigation fluid;

[0016] A composite pipe network system, which is embedded in the VSD sponge layer, includes multiple drainage pipes and flushing pipes, and supports switching between gravity drainage mode and VSD negative pressure drainage mode;

[0017] The longitudinal folding guide structure is integrated into a high-density layer and includes reinforcing ribs evenly distributed along the device axis and preset longitudinal weakening creases. The two are alternately spaced along the circumferential direction to guide the device to fold symmetrically and orderly along the axial direction after the airbag is deflated, thereby reducing the radial dimension.

[0018] In some embodiments of the present invention, the composite pipe network system includes four rows of pipes extending parallel to the longitudinal axis of the device, with three sub-pipes in each row, for a total of 12 sub-pipes, including 8 drainage sub-pipes and 4 flushing sub-pipes.

[0019] In some embodiments of the present invention, at the top of the device, eight drainage sub-pipes converge to form a main drainage network, and four flushing sub-pipes converge to form a main flushing network.

[0020] In some embodiments of the present invention, at the bottom of the device, the main drainage network converges into two independent drainage tubes, and the main flushing network converges into one independent flushing tube.

[0021] In some embodiments of the present invention, the two drainage tubes, one flushing tube, and the inflation tube communicating with the air bladder are combined into a multi-cavity integrated cable at the bottom of the device, and the multiple channels inside the cable are independently separated from each other.

[0022] In some embodiments of the present invention, in gravity drainage mode, the drainage tube is connected to a sterile drainage bag to achieve passive drainage; in VSD negative pressure drainage mode, the drainage tube is connected to a medical negative pressure aspirator to achieve negative pressure drainage.

[0023] In some embodiments of the present invention, the longitudinal folding guide structure includes multiple reinforcing ribs and multiple preset longitudinal weakening creases, all of which are straight structures extending along the axial direction, to achieve symmetrical and orderly folding after air extraction.

[0024] In some embodiments of the present invention, the four rows of pipes in the composite pipe network system are all located outside the reinforcing ribs and embedded in the VSD sponge layer.

[0025] In some embodiments of the present invention, the multi-cavity integrated cable is connected to the bottom of the device by a large-arc tapered transition, and the outer surface of the cable is provided with a hydrophilic lubricating coating.

[0026] In some embodiments of the present invention, the drainage tube is provided with a side hole communicating with the VSD sponge layer, and the flushing tube is provided with multiple distributed liquid outlet holes.

[0027] In some embodiments of the present invention, the internal pressure of the air-filled balloon is adjustable, and the support volume gradually decreases as the postoperative healing process progresses.

[0028] A second aspect of the present invention provides a method for preparing the above-mentioned device, comprising:

[0029] S1: Select foamed modified medical silicone rubber and preset gradient foaming parameters;

[0030] S2: Using a precision mold, the raw material is injected into the mold cavity in one go;

[0031] S3: Control the amount of foaming agent, heating temperature and cooling rate in different areas to simultaneously form a high-density dense layer, a low-density porous layer, a medium-density air bladder, a composite pipe network system and a longitudinal folding guide structure.

[0032] S4: After demolding, perform tests on sealing, connectivity, and channel isolation, and then clean and sterilize the packaging.

[0033] In some embodiments of the present invention, a high-density dense layer and a low-density porous layer are formed into an interface-free integrated structure by continuously varying the foaming ratio.

[0034] As described above, the present invention has the following beneficial effects:

[0035] 1. Highly integrated functions: It integrates dynamic support, negative pressure drainage, active irrigation, and minimally invasive removal to meet the full-cycle treatment needs after pelvic surgery;

[0036] 2. Full-area drainage and flushing: The four rows of 12 tubes with a top confluence layout achieve full coverage of the deep pelvic cavity, significantly improving drainage and flushing efficiency;

[0037] 3. Dual-mode free switching: early gravity drainage and later VSD negative pressure drainage, adapting to different healing stages;

[0038] 4. Adjustable dynamic support: The airbag pressure is adjustable, and the support volume gradually decreases as healing progresses, avoiding pressure damage;

[0039] 5. Minimally invasive and safe removal: The reinforcing ribs and weakened creases work together to guide axial symmetrical folding, significantly reducing radial dimensions, and allowing for smooth removal through the perineum;

[0040] 6. Reliable one-piece molding: Gradient density silicone rubber is molded in one piece, with no delamination or assembly failure, resulting in strong structural stability;

[0041] 7. Simple and user-friendly tubing: The multi-cavity integrated tubing design reduces external tubing entanglement and perineal irritation. Attached Figure Description

[0042] Figure 1 The diagram shows the overall structure of the device.

[0043] Figure 2 The diagram shows a cross-sectional view of the device.

[0044] Figure 3 The diagram shows a longitudinal cross-sectional view of the device.

[0045] Figure 4 The diagram shows the device in its axially folded state.

[0046] Figure 5 The diagram shows a cross-sectional view of a multi-cavity integrated cable.

[0047] Explanation of icon numbers:

[0048] 1. Reinforcing ribs; 2. Medium air bladder; 3. High-density dense layer; 4. Pre-set longitudinal weakening creases; 5. Drainage tube; 6. Inflation tube; 7. Flushing tube; 8. Main unit; 9. Low-density porous layer; 10. Drainage sub-pipe; 11. Flushing sub-pipe; 12. Multi-cavity integrated cable. Detailed Implementation

[0049] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

[0050] Please see Figure 1-5It should be noted that the illustrations provided in this embodiment are only schematic representations of the basic concept of the present invention. Therefore, the drawings only show the components related to the present invention and are not drawn according to the actual number, shape and size of the components in the actual implementation. In the actual implementation, the form, quantity and proportion of each component can be arbitrarily changed, and the layout of the components may also be more complex.

[0051] This device includes: main body unit 8, high-density dense layer 3, low-density porous layer 9, medium air bladder 2, drainage sub-pipe 10, flushing sub-pipe 11, drainage pipe 5, flushing pipe 7, reinforcing rib 1, preset longitudinal weakening crease 4, inflation pipe 6, and multi-cavity integrated cable 12.

[0052] 1. Main unit and gradient density structure:

[0053] The main unit 8 is an inverted pear-shaped cavity with a narrowed bottom to fit the perineum; it is made of foamed modified medical silicone rubber in one piece to form a gradient density integrated structure: the inner high-density dense layer 3 has good airtightness and high strength; the outer low-density porous layer 9 has three-dimensional interconnected pores; the two layers are continuously transitioned without a layered interface.

[0054] 2. Middle airbag and VSD foam layer:

[0055] The air bladder 2 is formed by a high-density, dense layer 3 enclosing the inner side. It is connected to an external air source via an inflation tube 6. After inflation, it supports the pelvic floor and prevents organs from falling. The pressure can be gradually adjusted to deflate and reduce the volume.

[0056] The VSD sponge layer consists of a high-density dense layer 3 on the outside and a low-density porous layer 9, which wraps the airbag 2. After expansion, it fits tightly against the wound surface, transmits negative pressure, collects exudate, and disperses irrigation fluid.

[0057] 3. Composite Pipeline System:

[0058] The composite pipe network system is embedded in the VSD sponge layer, with a total of four rows of 12 sub-pipes: 8 drainage sub-pipes 10 and 4 flushing sub-pipes 11.

[0059] Top: Drainage sub-pipe 10 merges and connects, flushing sub-pipe 11 merges and connects.

[0060] Bottom: Drainage sub-pipe 10 converges into two drainage pipes 5, and flushing sub-pipe 11 converges into one flushing pipe 7.

[0061] The drainage sub-channel 10 has side holes inside the VSD sponge layer to connect to the sponge layer, and the flushing sub-channel 11 has multiple sets of liquid outlet holes inside the sponge layer to achieve distributed flushing.

[0062] 4. Multi-cavity integrated conduit cable:

[0063] The multi-cavity integrated cable 12 is located at the bottom of the main unit 8. The drainage pipe 5, flushing pipe 7, and air inflator 6 are combined to form the multi-cavity integrated cable 12, which has multiple independent channels inside. The cable transitions to the bottom with a large arc-shaped tapered shape, and the surface is hydrophilic and lubricated, making it easy to insert and remove.

[0064] 5. Longitudinal folding guide structure:

[0065] The longitudinal folding guide structure includes multiple reinforcing ribs 1 and multiple preset longitudinal weakening creases 4, which are evenly distributed and alternately spaced along the axial direction. After air is drawn out, the reinforcing ribs 1 retract inward, and the weakening creases 4 bend preferentially. The guide device folds symmetrically and orderly along the axial direction, which facilitates minimally invasive removal.

[0066] 6. Work Mode:

[0067] (1) Perioperative period: balloon inflatable support, drainage tube connected to drainage bag, gravity drainage;

[0068] (2) Healing promotion period: The drainage tube is connected to a negative pressure suction device, VSD negative pressure drainage is performed, and the irrigation tube is used for intermittent irrigation;

[0069] (3) Dynamic adjustment period: gradually release air and reduce the support volume to adapt to the reduction of cavity size;

[0070] (4) Removal period: The air is completely depressurized, the device is folded axially, and the traction cable is removed through the perineum via a minimally invasive procedure.

[0071] 7. Preparation method:

[0072] S1: Select foamed modified medical silicone rubber and set gradient foaming parameters;

[0073] S2: Uses precision molds for one-time material injection;

[0074] S3: Control the amount of foaming agent, temperature and cooling rate in different areas to simultaneously form high-density layers, low-density layers, airbags, pipe networks and folded structures;

[0075] S4: Demolding test to check sealing, connectivity and channel isolation;

[0076] S5: Cleaning, sterilization, and packaging.

[0077] The above embodiments are merely illustrative of the principles and effects of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by those skilled in the art without departing from the spirit and technical concept disclosed in the present invention should still be covered by the claims of the present invention.

Claims

1. A VSD support and drainage integrated device for postoperative full pelvic surgery, characterized in that, include: The main body unit (8) is made of foamed modified medical silicone rubber in one molding process. The whole body is a cavity adapted to the anatomical structure of the human pelvis, in the shape of an inverted pear or saddle, with the bottom narrowed to adapt to the perineal outlet. The main body unit (8) is a gradient density structure, which is formed by the continuous change of the foaming ratio between the inner high-density dense layer (3) and the outer low-density porous layer (9), without physical layering interface. The air bladder (2) is formed by a high-density dense layer (3), which provides physical support for the pelvic floor after inflation, and the internal pressure can be dynamically adjusted. VSD sponge layer, which is composed of a low-density porous layer (9) and is wrapped around the outside of the air bladder (2). It has three-dimensional interconnected pores and is used to fit the wound surface, conduct negative pressure, collect exudate and disperse irrigation fluid. A composite pipe network system, which is embedded in the VSD sponge layer, includes multiple drainage pipes (5) and flushing pipes (7), and supports switching between gravity drainage mode and VSD negative pressure drainage mode; The longitudinal folding guide structure is integrated into a high-density layer (3) and includes reinforcing ribs (1) evenly distributed along the axial direction of the device and preset longitudinal weakening creases (4). The two are alternately arranged along the circumferential direction to guide the device to fold symmetrically and orderly along the axial direction after the airbag is deflated, thereby reducing the radial dimension.

2. The apparatus according to claim 1, characterized in that, The composite pipe network system includes four rows of pipes extending parallel to the longitudinal axis of the device, with three sub-pipes in each row, for a total of 12 sub-pipes, including 8 drainage sub-pipes (10) and 4 flushing sub-pipes (11).

3. The apparatus according to claim 2, characterized in that, At the top of the device, 8 drainage sub-pipes (10) converge to form the main drainage network, and 4 flushing sub-pipes (11) converge to form the main flushing network.

4. The apparatus according to claim 3, characterized in that, At the bottom of the device, the main drainage network converges into two independent drainage pipes (5), and the main flushing network converges into one independent flushing pipe (7).

5. The apparatus according to claim 4, characterized in that, The two drainage tubes (5), one flushing tube (7), and the inflation tube (6) connected to the air bladder (2) are combined at the bottom of the device into a multi-cavity integrated cable (12), with multiple channels inside the cable being independently separated from each other.

6. The apparatus according to claim 1, characterized in that, In gravity drainage mode, the drainage tube (5) is connected to a sterile drainage bag to achieve passive drainage; in VSD negative pressure drainage mode, the drainage tube (5) is connected to a medical negative pressure aspirator to achieve negative pressure drainage.

7. The apparatus according to claim 1, characterized in that, The longitudinal folding guide structure includes multiple reinforcing ribs (1) and multiple preset longitudinal weakening creases (4), all of which are straight structures extending along the axial direction, achieving symmetrical and orderly folding after air extraction.

8. The apparatus according to claim 1, characterized in that, The four rows of pipes in the composite pipe network system are all located outside the reinforcing rib (1) and embedded in the VSD sponge layer.

9. The apparatus according to claim 5, characterized in that, The multi-cavity integrated cable (12) is connected to the bottom of the device with a large-arc tapered transition, and the outer surface of the cable is provided with a hydrophilic lubricating coating.

10. The apparatus according to claim 1, characterized in that, The drainage tube (5) is provided with a side hole that communicates with the VSD sponge layer, and the flushing tube (7) is provided with multiple distributed liquid outlet holes.

11. The apparatus according to claim 1, characterized in that, The internal pressure of the air-filled balloon (2) is adjustable, and the support volume gradually decreases as the postoperative healing process progresses.

12. A method for preparing the apparatus according to any one of claims 1 to 11, characterized in that, include: S1: Select foamed modified medical silicone rubber and preset gradient foaming parameters; S2: Using a precision mold, the raw material is injected into the mold cavity in one go; S3: Control the amount of foaming agent, heating temperature and cooling rate in different areas to simultaneously form a high-density dense layer (3), a low-density porous layer (9), a medium-density air bladder (2), a composite pipeline system and a longitudinal folding guide structure; S4: After demolding, perform tests on sealing, connectivity, and channel isolation, and then clean and sterilize the packaging.

13. The preparation method according to claim 12, characterized in that, The high-density dense layer (3) and the low-density porous layer (9) form an interface-free integrated structure through continuous changes in foaming ratio.

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