Artificial anus reconstruction device

Abstract

The invention discloses an artificial anus reconstruction device, relates to the technical field of medical instruments, solves the initial problem that an artificial anus reconstruction device capable of maintaining intestinal continuity and reducing the risk of causing hernia, the probability of avascular necrosis of the intestinal end and infection around a stoma is lacked, and can greatly improve the living quality of a patient. The device comprises a first tube body and a second tube body, the ends of the first tube body and the second tube body are in butt joint and fixed, and the end, away from the second tube body, of the first tube body is matched with the intestinal end through an anastomat; a connector is arranged at the end, away from the first pipe body, of the second pipe body. The first tube body is responsible for biological integration so that intestinal cells can be stably combined with the artificial anus, the second tube body is responsible for achieving the effects of mechanical supporting and long-term stability, due to the design of the connector, external valves, collection bags and other expansions can be conveniently connected, and the expansibility of the whole system is enhanced. Through the arrangement, the continuity of the intestinal tract is improved, the risk of causing hernia and the probability of avascular necrosis of the intestinal end are reduced, and the living quality of a patient is improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a reconstructed artificial anus device. Background Art

[0002] In the field of colorectal cancer treatment, patients with low rectal cancer often cannot retain anal function due to the too low position of the tumor. It is necessary to permanently lead the end of the intestine out of the body through a stoma operation, turn the end of the intestine outwards and suture it to the abdominal wall skin to form an opening with a diameter of 2 - 3 cm, and rely on an external stoma bag and a sticky chassis to collect excrement, which needs to be emptied 4 - 6 times a day. However, due to the long-term exposure of the mucosa, bacterial colonization is caused. The infection rate around the stoma of this surgical method reaches 15% - 30%, and it is easy to cause excrement leakage due to the failure of the adhesive. About 40% of patients have skin ulcers. Patients need to spend 45 - 60 minutes a day nursing the stoma, and nocturnal excretion disturbs sleep; due to the limitation of the external stoma bag, clothing choices are restricted, and social activities such as swimming and sports are forced to stop. Therefore, although the existing stoma technology can save lives, it will bring long-term physical and mental burdens to patients; in the existing anal reconstruction technology, an artificial extension tube is used for externalization of the intestinal tube, but this solution will cut off the continuity of the intestine, cannot guide vascularization or nerve regeneration, and the long-term stimulation of foreign bodies causes the level of inflammatory factors to increase by 2 - 3 times, easily leading to the risk of hernia and the probability of ischemic necrosis of the intestinal end; therefore, there is currently a lack of a reconstructed artificial anus that can maintain the continuity of the intestine, reduce the risk of hernia and the probability of ischemic necrosis of the intestinal end, and infection around the stoma. Summary of the Invention

[0003] To solve the above technical problems, the present invention provides a reconstructed artificial anus device. The first tube body is responsible for biological integration to firmly combine intestinal cells with the artificial anus, the second tube body is responsible for providing mechanical support and long-term stability effects, and the design of the interface facilitates the connection of external valves, collection bags, and other extensions, enhancing the expandability of the overall system; through the above settings, the continuity of the intestine is improved, and the risk of hernia and the probability of ischemic necrosis of the intestinal end are reduced.

[0004] The technical solution adopted by the present invention is as follows:

[0005] A reconstructed artificial anus device includes a first tube body and a second tube body. The end of the first tube body is butt-jointed and fixed with the end of the second tube body. The end of the first tube body away from the second tube body is anastomosed with the intestinal end through a stapler; an interface is provided at the end of the second tube body away from the first tube body.

[0006] With the above technical solution, the first tube body is responsible for biological integration to firmly combine intestinal cells with the artificial anus, the second tube body is responsible for providing mechanical support and long-term stability, and the interface design facilitates the connection of external valves, collection bags, and other extensions, enhancing the expandability of the overall system; through the above settings, the continuity of the intestine is improved, and the risk of hernia and the probability of intestinal ischemia and necrosis are reduced.

[0007] Preferably, the first tube body is made of one of a polymer material facilitating the crawling growth of intestinal cells, other biocompatible metals, and other biocompatible polymer materials.

[0008] With the above technical solution, the unique surface chemical properties of the polymer material can promote the migration of intestinal epithelial cells. When the intestinal epithelial cells are fused with the polymer material on the first tube body, they are fixed to the reconstructed artificial anus device.

[0009] Preferably, the second tube body is made of a flexible polymer material.

[0010] Further, the flexible polymer material is biocompatible silicone.

[0011] With the above technical solution, the elastic modulus of silicone can match the soft tissue of the intestine, reduce chronic damage caused by mechanical friction, and the silicone material can avoid intestinal tissue leakage.

[0012] Preferably, the surface of the interface is provided with an antibacterial material, and the antibacterial material is an antibacterial coating that covers the surface of the interface.

[0013] With the above technical solution, the antibacterial coating of the antibacterial material can inhibit Escherichia coli and Staphylococcus aureus.

[0014] Preferably, the first tube body is made into a porous scaffold with one of a composite material of polycaprolactone and silk fibroin, titanium alloy, and nitinol.

[0015] Preferably, the first tube body is made into a porous scaffold with a composite material of polycaprolactone and silk fibroin, and the ratio of the composite material of polycaprolactone and silk fibroin is 2-2.5:1.

[0016] Further, the polycaprolactone and silk fibroin are prepared into a scaffold by electrospinning.

[0017] With the above technical solution, after the polycaprolactone and silk fibroin are compounded, the degradation period is extended, and the degradation period is optimized to 1.5-2 years, synchronized with tissue regeneration; and the ability to resist intestinal lumen pressure fluctuations is increased; the introduction of silk fibroin triples the cell adhesion density; and the composite setting of the above materials increases the migration rate by more than 1.1 mm / day.

[0018] Preferably, the porosity of the first tube body is 60% - 80%.

[0019] With the above technical solution, the above void ratio maximally supports the directional crawling of epithelial cells, while taking into account both supportiveness and flexibility, avoiding collapse or stress concentration; when the porosity is less than 60%, cell migration is hindered, and when the porosity is greater than 80%, the cells are loosely distributed and the adsorption amount of fibronectin decreases.

[0020] Further, the first tube body adopts a micro-groove structure design, the depth of the groove is 50 μm, and the pitch of the groove is 200 μm.

[0021] With the above technical solution, since the length of the intestinal cell pseudopodia is 50 μm, the depth of the groove facilitates the embedding and anchoring of the intestinal cell pseudopodia; the cell cluster size of intestinal epithelial cells is 100 - 150 μm, so the 200 μm pitch of the groove facilitates preventing tearing when multicellular clusters cross, thereby maximizing the migration rate of intestinal cells.

[0022] Further, the first pipeline adopts a dual-scale pore composite design, and the dual-pore structure is composed of macropores of 190 - 200 μm and micropores of 20 μm.

[0023] With the above technical solution, the macropores facilitate providing a channel for vascular granulation invasion and a path for cell migration. The micropores are embedded in the side walls of the macropores. In order to induce cell migration, a VEGF (vascular endothelial growth factor) coating will be applied on the first pipeline, and the micropores facilitate adsorbing and carrying VEGF (vascular endothelial growth factor).

[0024] Preferably, pressure sensors are spirally distributed on the first tube body. The pressure sensors are wirelessly connected to a Bluetooth module, the Bluetooth module is encapsulated inside the second tube body, and the Bluetooth module is wirelessly connected to a control system.

[0025] With the above technical solution, the pressure in the intestinal cavity is collected at fixed intervals, thereby predicting the defecation demand in advance and significantly reducing the incontinence rate.

[0026] Further, the pressure sensors adopt MEMS pressure sensors and are wirelessly powered by a near-field coupling coil; the surface of the sensors is coated with a polydopamine layer with a thickness of 200 nanometers, which facilitates promoting the coverage of intestinal endothelial cells.

[0027] Preferably, several shape memory alloy springs are embedded inside the second tube body. The several shape memory alloy springs are arranged along the axial direction of the second tube body, and the expansion and contraction direction of the shape memory alloy springs is along the circumferential direction of the second tube body.

[0028] With the above technical solution, the shape memory alloy spring provides a radial warning example, thus mimicking the resting pressure state of the anus. When the pressure increases, the silica gel deforms and opens, and when the pressure decreases, the spring drives it to close.

[0029] Preferably, the interface adopts a threaded connection opening and a cover body. An internal thread is provided on the opening, and an external thread matching the internal thread is provided on the cover body.

[0030] With the above technical solution, the threaded connection supports single-handed quick opening and closing, realizes a strong sealing ability, and can adapt to a variety of external devices, reducing the use and manufacturing costs.

[0031] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are as follows:

[0032] The first tube body is responsible for biological integration, so that the intestinal cells are firmly combined with the artificial anus. The second tube body is responsible for providing mechanical support and long-term stability effects. The design of the interface facilitates the connection of external valves, collection bags, and other extensions, enhancing the expandability of the overall system; through the above settings, the continuity of the intestine is improved, and the risk of hernia and the probability of intestinal ischemia and necrosis are reduced. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] The present invention will be described by way of examples with reference to the accompanying drawings, where:

[0034] Figure 1 is a schematic structural diagram of a reconstructed artificial anus device in the present invention;

[0035] Figure 2 is a schematic structural diagram of the grooves and large holes distribution on the first tube body in Embodiments 4 and 5 of the present invention;

[0036] Figure 3 is a schematic structural diagram of the double pores in Embodiment 5 of the present invention;

[0037] Figure 4 is a schematic structural diagram of the shape memory alloy spring in Embodiment 7 of the present invention;

[0038] Figure 5 is a schematic diagram of the present invention in use.

[0039] REFERENCE SIGNS

[0040] 1 - First tube body, 2 - Second tube body, 3 - Interface, 4 - Groove, 5 - Large hole, 6 - Micropore, 7 - Spring, 8 - Abdomen. DETAILED DESCRIPTION OF THE INVENTION

[0041] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the following will clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the described embodiments are only a part of the embodiments of this application, rather than all the embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative efforts belong to the scope protected by this application.

[0042] Embodiment 1

[0043] A reconstructed artificial anus device, referring to the attached Figure 1 , includes a first tube body 1 and a second tube body 2. The ends of the first tube body 1 and the second tube body 2 are butt-jointed and fixed. The end of the first tube body 1 away from the second tube body 2 is anastomosed with the intestinal end by a stapler; an interface 3 is provided at the end of the second tube body 2 away from the first tube body 1; the first tube body 1 is responsible for biological integration to firmly combine intestinal cells with the artificial anus, the second tube body 2 is responsible for providing mechanical support and long-term stability effects, and the design of the interface 3 facilitates the connection of external valves, collection bags, and other extensions, enhancing the expandability of the overall system; through the above settings, the continuity of the intestine is improved, and the risk of hernia and the probability of intestinal end ischemia and necrosis are reduced.

[0044] In this embodiment, the first tube body 1 is made of a polymer material that facilitates the crawling growth of intestinal cells; the unique surface chemical properties of the polymer material can promote the migration of intestinal epithelial cells, and when the intestinal epithelial cells are fused with the polymer material on the first tube body 1, they are fixed to the reconstructed artificial anus device.

[0045] In this embodiment, the second tube body 2 is made of biocompatible silicone; the elastic modulus of the silicone can match the soft tissue of the intestine, reducing chronic damage caused by mechanical friction, and the silicone material can avoid intestinal tissue leakage.

[0046] In this embodiment, the surface of the interface 3 is provided with an antibacterial material, and the antibacterial material is an antibacterial coating that covers the surface of the interface 3; the coating of the antibacterial material can inhibit Escherichia coli and Staphylococcus aureus.

[0047] The usage steps of the reconstructed artificial anus device in this embodiment are as follows:

[0048] The usage steps of a reconstructed artificial anus device are as follows:

[0049] Step 1: Referring to the attached Figure 5 , during the operation, the patient pulls the intestinal tube to a position flush with the skin of the outer wall of the abdomen 8, fixes the intestinal tube to the skin wall of the outer wall of the abdomen 8, and coats the first tube body 1 with a VEGF (vascular endothelial growth factor) coating;

[0050] Step 2: Use a stapler to anastomose the proximal end of the first tube body 1 with the intestinal stump; at this time, the second tube body 2 is located outside the outer wall of the abdomen 8 to serve as a passage.

[0051] Step 3: Unscrew and clean the threaded interface 3 three times a day, check the resilience performance of the memory spring 7 every month; perform porosity detection every six months.

[0052] Example 2

[0053] Different from Example 1, in this example, the first tube body 1 is made of a porous scaffold of a composite material of polycaprolactone and silk fibroin, and the ratio of the polycaprolactone to the silk fibroin composite material is 2-2.5:1.

[0054] In this example, polycaprolactone and silk fibroin are prepared into a scaffold by electrospinning; after the polycaprolactone and silk fibroin are combined, the degradation period is extended, and the degradation period is optimized to 1.5-2 years, which is synchronized with tissue regeneration; and the ability to resist intestinal lumen pressure fluctuations is increased; the introduction of silk fibroin triples the cell adhesion density; and the composite setting of the above materials increases the migration rate by more than 1.1 mm / day.

[0055] Example 3

[0056] Different from Example 1, in this example, the porosity of the first tube body 1 is 60% - 80%; the above porosity maximally supports the directional crawling of epithelial cells, while taking into account the supportiveness and flexibility, avoiding collapse or stress concentration; when the porosity is less than 60%, cell migration is blocked, and when the porosity is greater than 80%, the cells are loosely distributed and the adsorption amount of fibronectin decreases;

[0057] Among them, the porosity of the first tube body 1 is 75%, and the ratio of the polycaprolactone to the silk fibroin composite material is 2.5:1. By coordinating the porosity and the silk fibroin content, the effects of both extending the degradation period and increasing the migration rate can be achieved.

[0058] Example 4

[0059] Different from Example 1, referring to the appendix Figure 2 , in this example, the first tube body 1 adopts a microgroove 4 structure design, the depth of the groove 4 is 50 μm, and the spacing of the groove 4 is 200 μm; since the length of the intestinal cell pseudopodia is 50 μm, the depth of the groove 4 facilitates the embedding and anchoring of the intestinal cell pseudopodia; the cell cluster size of intestinal epithelial cells is 100 - 150 μm, so the 200 μm spacing of the groove 4 facilitates preventing tearing when multicellular clusters cross, thereby maximizing the migration rate of intestinal cells.

[0060] Example 5

[0061] Different from Example 1, referring to the appendix Figures 2-3 , in this embodiment, the first pipeline adopts a dual-scale pore composite design, and the dual-pore structure is composed of macropores 5 with a size of 190-200 μm and micropores 6 with a size of 20 μm; the macropores 5 facilitate providing channels for vascular granulation invasion and paths for cell migration, and the micropores 6 are embedded in the side walls of the macropores 5. In order to induce cell migration, a VEGF (vascular endothelial growth factor) coating will be applied on the first pipeline, and the micropores 6 are convenient for adsorbing and carrying VEGF (vascular endothelial growth factor);

[0062] Among them, the pore diameter of the macropores in this application is 190 μm, and the macropores are distributed at the intervals between the grooves 4. The 190-μm macropores provide sufficient space for cell migration and at the same time allow capillary buds to grow in; the macropores 5 distributed within the intervals of the grooves 4 form a "migration corridor" to accelerate the cell infiltration rate; the groove structure induces cells to align along the long axis direction of the grooves 4 through the contact guidance effect, while the macropores 5 between the grooves 4 allow cells to expand in multiple dimensions to form a three-dimensional network closer to natural tissues.

[0063] Example 6

[0064] Different from Example 1, in this embodiment, pressure sensors are spirally distributed on the first tube body 1, the pressure sensors are connected to a Bluetooth module through radio, the Bluetooth module is encapsulated inside the second tube body 2, and the Bluetooth module is connected to a control system through radio; the pressure in the intestinal lumen is collected at fixed intervals, so as to predict the defecation demand in advance and significantly reduce the incontinence rate.

[0065] In this embodiment, the pressure sensors adopt MEMS pressure sensors and are wirelessly powered by a near-field coupling coil; the surface of the sensors is coated with a polydopamine layer with a thickness of 200 nanometers to facilitate the coverage of intestinal endothelial cells;

[0066] This application combines several technical points such as improving the adhesion density, migration rate of intestinal cells, and micro-groove structure to further improve the pressure sensors:

[0067] (1) The high adhesion density enables the formation of a continuous monolayer between cells, avoiding pressure transmission loss caused by cell gaps, and reducing the sensing error of the sensor for intestinal lumen pressure to ±1.2 cmH2O (the error of the traditional structure is ±5 cmH2O);

[0068] (2) Enhance the mechanical conduction efficiency of the cell layer, and reduce the pressure signal attenuation rate by 60%;

[0069] (3) Match the pseudopod extension length of intestinal epithelial cells, promote the directional arrangement of cells through the contact guidance effect, make the pressure transmission path consistent with the sensor axis, and thus increase the axial force detection sensitivity by 40%;

[0070] (4) The cell layer arranged in a directional manner forms a conformal contact with the surface of the pressure sensor, reducing the loss of interfacial shear stress;

[0071] (6) The live cell layer provides real-time feedback on local stress changes through mechanically sensitive ion channels, cross-verifying with the electrical signals of the sensor, and increasing the data confidence level to 99.2%.

[0072] Example 7

[0073] Different from Example 1, referring to the appendix Figure 4 , in this embodiment, several shape memory alloy springs 7 are embedded inside the second tube body 2. The several shape memory alloy springs 7 are arranged along the axial direction of the second tube body 2, and the expansion and contraction direction of the shape memory alloy springs 7 is along the circumferential direction of the second tube body 2; the shape memory alloy springs 7 provide a radial warning example, thus imitating the resting pressure state of the anus. When the pressure increases, the silica gel deforms and opens, and when the pressure decreases, the spring 7 drives it to close.

[0074] In this embodiment, the usage steps of a reconstructed artificial anus device are as follows:

[0075] Step 1: Referring to the appendix Figure 5 , during the operation, the patient pulls the intestinal tube to a position flush with the skin on the outer wall of the abdomen 8, fixes the intestinal tube to the skin wall on the outer wall of the abdomen 8, and coats the first tube body 1 with a VEGF (vascular endothelial growth factor) coating;

[0076] Step 2: Use a stapler to anastomose the proximal end of the first tube body 1 with the intestinal stump; at this time, the second tube body 2 is located inside the abdomen 8, and the first tube body 1 and the second tube body 2 are mutually embedded, facilitating the subsequent embedding of intestinal cells with the second tube body 2;

[0077] Step 3: Activate the Bluetooth module to pair with the control system, and monitor the change of intestinal lumen pressure through sensor data; and observe the epithelial cell migration progress every week;

[0078] Step 4: Unscrew and clean the threaded interface 3 three times a day, check the springback performance of the memory spring 7 every month; perform porosity detection every six months.

[0079] Example 8

[0080] Different from Example 1, in this embodiment, the interface 3 adopts a threaded connection opening and a cover body. An internal thread is provided on the opening, and an external thread matching the internal thread is provided on the cover body; the interface 3 is buried in the patient's abdomen 8, and the existence of the interface 3 is not visible during use, which is more beautiful; the threaded connection supports quick opening and closing with one hand, realizes a strong sealing ability, and can be adapted to a variety of external devices, reducing the use and manufacturing costs.

[0081] It should be noted that:

[0082] The foregoing description of the disclosed embodiments enables those skilled in the art to practice or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A reconstructed artificial anus device, characterized in that, It includes a first tube body (1) and a second tube body (2). The ends of the first tube body (1) and the second tube body (2) are butt-jointed and fixed. One end of the first tube body (1) far from the second tube body (2) is anastomosed with the intestinal end by a stapler; an interface (3) is provided at one end of the second tube body (2) far from the first tube body (1).

2. The reconstructed artificial anus device according to claim 1, wherein The first tube body (1) is made of one of a polymer material facilitating the crawling growth of intestinal cells, other biocompatible metals, and other biocompatible polymer materials.

3. The reconstructed artificial anus device according to claim 1, wherein, The second tube body (2) is made of a flexible polymer material.

4. The reconstructed artificial anus device according to claim 1, characterized in that, An antibacterial material is provided on the surface of the interface (3), and the antibacterial material is an antibacterial coating that covers the surface of the interface (3).

5. The reconstructed artificial anus device according to claim 2, wherein, The first tube body (1) is made of one of a composite material of polycaprolactone and silk fibroin, titanium alloy, and nitinol to form a porous scaffold.

6. The reconstructed artificial anus device according to claim 5, wherein, The first tube body (1) is made of a composite material of polycaprolactone and silk fibroin to form a porous scaffold, and the ratio of the polycaprolactone and silk fibroin composite material is 2 - 2.5:

1.

7. The reconstructed artificial anus device according to claim 6, characterized in that, The porosity of the first tube body (1) is 60% - 80%.

8. The reconstructed artificial anus device according to claim 2, characterized in that, Pressure sensors are spirally distributed on the first tube body (1). The pressure sensors are connected to a Bluetooth module by radio. The Bluetooth module is encapsulated inside the second tube body (2), and the Bluetooth module is connected to a control system by radio.

9. The reconstructed artificial anus device according to claim 3, wherein, Several shape memory alloy springs (7) are embedded inside the second tube body (2). The several shape memory alloy springs (7) are arranged along the axial direction of the second tube body (2), and the expansion and contraction direction of the shape memory alloy springs (7) is along the circumferential direction of the second tube body (2).

10. A reconstructed artificial anus device according to any one of claims 1 to 9, characterized in that, The interface (3) adopts a threaded opening and a cover body. Internal threads are provided on the opening, and external threads matching the internal threads are provided on the cover body.

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