A magnetic control porcelain bead ring for controlling defecation of an enterostomy and a control method thereof

Abstract

The application discloses a magnetic control porcelain bead ring for controlling defecation of an enterostomy and a control method thereof, and relates to the technical field of medical devices. The porcelain bead ring comprises a ring-shaped base body and a magnetic bead assembly installed in the ring-shaped base body; the magnetic bead assembly comprises a plurality of magnetic beads which are uniformly arranged on the inner side wall of the ring-shaped base body in the circumferential direction, and the magnetic polarities of adjacent magnetic beads are opposite to each other, so that a ring-shaped closed magnetic field with the magnetic adsorption force concentrated in the center area of the enterostomy is formed; wherein a magnetic field adjusting module is arranged in the ring-shaped base body and is used for generating a magnetic field which is opposite to the direction of the ring-shaped closed magnetic field, so as to control the diameter of the enterostomy by changing the magnetic adsorption force. The application can improve the convenience and tolerance of the patient and improve the postoperative life quality of the patient.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more particularly to medical enterostomy care devices, specifically a magnetically controlled ceramic bead ring for controlling defecation in an enterostomy and its control method. Background Technology

[0002] Enterostomy is a common surgical procedure for treating diseases such as colorectal cancer and intestinal obstruction. Patent documents CN102834074A and WO2022258832A1 both involve medical devices used for this type of surgery.

[0003] CN102834074A relates to a stoma device comprising an implant positioned within the body near a stoma during use, and a discharge device positioned to facilitate the drainage of intestinal waste to the outside of the body. The discharge device is held at the stoma location by magnetic attraction between the implant and the discharge device, enabling a removable design. The discharge device includes a tubular member inserted into the intestine, a flange member with an inflatable bladder, and a manually operated control valve to control the drainage of waste. Therefore, although the device improves user comfort by using magnetism instead of adhesive to secure the discharge device, the patient still needs to manually control defecation via the valve.

[0004] WO2022258832A1 proposes a controllable intestinal closure system. This system involves placing a controllable intestinal closure device within the body and implanting a magnetized internal substrate in the abdominal wall. An external substrate is then magnetically sealed to the internal substrate. Under normal conditions, the intestine is closed, functioning similarly to a sphincter. When defecation is needed, the closure device opens, allowing waste to be introduced into the ostomy bag. This system, by applying a closure and magnetic adhesion mechanism to the ostomy care system, enables rapid and uncomplicated ostomy bag changes, allowing ostomy patients to, for example, ride bicycles or jog without the ostomy bag.

[0005] While the controlled bowel closure system represents a significant improvement in ease of use and comfort compared to previous stoma devices, its complex structure, requiring multiple components within the patient's body, leads to surgical complexity and a higher risk of infection. Furthermore, the controlled bowel closure system achieves closure through the physical compression of an inflatable cuff, posing a risk of pressure damage to the mucosa. Summary of the Invention

[0006] The purpose of this invention is to provide a magnetically controlled ceramic bead ring and its control method for controlling defecation in an enterostomy, so as to avoid intestinal compression damage while ensuring sealing and reducing the leakage rate.

[0007] In a first aspect, embodiments of the present invention disclose a magnetically controlled ceramic bead ring for controlling defecation in an enterostomy, comprising an annular substrate and a magnetic bead assembly installed in the annular substrate; the magnetic bead assembly comprises multiple magnetic beads uniformly disposed along the circumferential direction on the inner annular sidewall of the annular substrate, with adjacent magnetic beads having opposite magnetic polarities to form an annular closed magnetic field with magnetic adsorption force concentrated in the central region of the stoma; wherein, a magnetic field adjustment module is provided in the annular substrate for generating a magnetic field opposite in direction to the annular closed magnetic field, so as to control the diameter of the enterostomy by changing the magnetic adsorption force.

[0008] In another example, each magnetic bead is mounted on a ring-shaped base by multiple titanium alloy springs.

[0009] In another example, the magnetic beads are made of a composite material, including a core, a core encapsulation layer, and a surface layer. The core is made of neodymium iron boron ferrite composite magnet, the core encapsulation layer is a zirconia ceramic shell, and the surface layer is a hydroxyapatite (HA) coating wrapped around the surface of the ceramic shell.

[0010] In another example, the surface layer of the magnetic beads facing the center of the annular matrix also includes a mucosal repair sustained-release layer, which uses sodium alginate-chitosan composite gel, loaded with growth factors and traditional Chinese medicine extracts, and the surface of the mucosal repair sustained-release layer is provided with micropores.

[0011] In another example, the surface magnetic flux density of a single magnetic bead increases linearly from the inner to the outer ring along the radial direction of the annular substrate.

[0012] In another example, the magnetic field conditioning module includes a micro battery and an electromagnetic coil wrapped around a toroidal substrate, with at least part of the magnetic bead having a built-in micro pressure sensor connected to the magnetic field conditioning module.

[0013] In another example, the magnetic field adjustment module includes a Bluetooth module.

[0014] In another example, an elastic buffer layer is also included, located on the inner wall of the annular substrate, covering the outer side of the magnetic bead assembly, and bonded to the annular substrate with epoxy adhesive.

[0015] Secondly, embodiments of the present invention disclose a method for controlling defecation through an enterostomy using the aforementioned magnetically controlled ceramic bead ring. When a defecation command is received, the magnetic field adjustment module is activated to generate a reverse magnetic field, which reduces the surface magnetic induction intensity of the magnetic beads, weakens the magnetic adsorption force, and increases the diameter of the enterostomy to an open state, allowing the patient to defecate normally. When a closing command is received, the magnetic field adjustment module closes the reverse magnetic field, the magnetic beads restore their magnetic adsorption force, and the diameter of the enterostomy decreases back to a closed state.

[0016] In another example, the command is sent via an external controller.

[0017] Beneficial effects: This invention utilizes a magnetic field adjustment module to regulate the gradient magnetic force of magnetic beads to achieve dynamic closure of the enterostomy, ensuring both airtightness and avoiding intestinal compression. Simultaneously, this invention improves the biocompatibility of the implant, integrates a sustained-release function of traditional Chinese medicine, alleviates intestinal mucosal irritation, and reduces the risk of inflammation and bleeding.

[0018] In summary, this invention can improve the convenience and tolerability of patient use and improve the quality of life of patients after surgery.

[0019] Other features and advantages of the invention will become clear from the following detailed description of exemplary embodiments of the invention with reference to the accompanying drawings. Attached Figure Description

[0020] The accompanying drawings, which are included to provide a further understanding of the invention and form part of this invention, illustrate exemplary embodiments of the invention and are used to explain the invention, but do not constitute an undue limitation of the invention. In the drawings: Figure 1 This is a schematic diagram of a magnetically controlled ceramic bead structure for automatic defecation control in an enterostomy according to an embodiment of the present invention; Figure 2 This is a schematic diagram of the composition of the magnetic bead composite material according to an embodiment of the present invention; Figure 3 This is a schematic diagram of the manufacturing process of a magnetic bead assembly according to an embodiment of the present invention; Figure 4 This is a schematic diagram of the ring matrix preparation process according to an embodiment of the present invention. Detailed Implementation

[0021] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0022] Enterostomy is a common surgical procedure for treating colorectal cancer, intestinal obstruction, and other diseases. Post-operatively, patients need to excrete feces through an abdominal stoma. Traditional care relies on ostomy bags for collection, but this presents problems such as odor leakage, skin irritation, and limited mobility. Similar to patent documents CN102834074A and WO2022258832A1, this invention also relates to an enterostomy device for use by individuals who have undergone stoma surgery, such as colostomy or ileostomy.

[0023] To address the shortcomings of existing devices and improve patients' quality of life, an implantable anti-reflux device, similar to the magnetic bead rings used in gastroesophageal reflux surgery (e.g., an implantable anti-reflux device disclosed in patent document CN105997296A), has been considered. However, in practice, it has been found that directly applying this device to enterostomies has significant limitations. For example, magnetic beads can easily overcompress the intestinal mucosa, leading to local circulatory disorders, causing mucosal ischemia, bleeding, or even perforation. Simultaneously, the large pressure fluctuations during intestinal peristalsis can easily result in incomplete closure under low pressure and compression damage under high pressure. Furthermore, magnetic beads may induce bacterial adhesion and inflammatory responses.

[0024] Therefore, embodiments of the present invention propose a magnetically controlled ceramic bead ring for automatic control of defecation in enterostomy, such as... Figure 1 As shown, it includes an annular substrate 1 and a magnetic bead assembly 2 installed in the annular substrate 1.

[0025] The annular matrix, for example, is made of polyetheretherketone (PEEK), and is circular in shape. Its inner diameter is adapted to the diameter of an adult enterostomy, for example, 2.5-3 cm, its outer diameter is 4-4.5 cm, and its thickness is 1.5-2 mm. This allows its tensile strength, flexural modulus, and other parameters to withstand the mechanical stress of long-term intestinal peristalsis. Exemplarily, the annular matrix can be a single piece or a separate structure.

[0026] The magnetic bead assembly includes 6 to 8 magnetic beads, which are evenly arranged on the inner sidewall of the annular substrate. The magnetic polarities of adjacent magnetic beads are opposite, that is, the N pole and S pole are arranged alternately along the circumferential direction to form an annular closed magnetic field. This allows the magnetic attraction force to be concentrated in the central area of ​​the stoma. When closed, the stoma diameter can be reduced from 2-3 cm to 0.3-0.5 cm to meet the leakage prevention requirements.

[0027] According to an embodiment of the present invention, the magnetic beads are made of a composite material, including a core 21, a core encapsulation layer 22, and a surface layer 23.

[0028] In one example, core 21 uses neodymium iron boron ferrite composite magnets, prepared by powder metallurgy, for example, with a density of 7.3-7.5 g / cm³. 3 This allows it to maintain magnetic stability in the intestinal temperature environment.

[0029] In one example, the core encapsulation layer 22 is a zirconia ceramic shell with a sandblasted surface, for example, a thickness of 0.3 mm, to prevent the magnetic material from directly contacting the intestine.

[0030] In one example, surface layer 23 is a hydroxyapatite (HA) coating wrapped around the surface of the ceramic shell, prepared by a sol-gel method, for example, with a thickness of 50-100 nm, to improve biocompatibility and reduce bacterial adhesion.

[0031] In one example, the surface layer 23 also includes a mucosal repair sustained-release layer, for example, disposed on the side of the magnetic beads facing the center of the annular matrix, using a sodium alginate-chitosan composite gel, loaded with growth factors and traditional Chinese medicine extracts. The growth factor, for example, is EGF, used to promote mucosal repair, and the traditional Chinese medicine extract, for example, is baicalin, used to inhibit intestinal inflammation and reduce the risk of mucosal bleeding. Furthermore, micropores can be formed on the surface of the mucosal repair sustained-release layer, thereby both preserving magnetic penetration and facilitating mucus permeation, maintaining a moist environment on the intestinal surface.

[0032] According to an embodiment of the present invention, each magnetic bead forms a gradient magnetic force distribution, that is, the surface magnetic induction intensity of a single magnetic bead increases linearly from the inner circle to the outer circle along the radial direction of the annular substrate. For example, the magnetic induction intensity of the innermost bead is 800-1000 Gs, and that of the outermost bead is 1200-1500 Gs. For example, each magnetic bead is connected to the annular base 1 via multiple titanium alloy springs 3 to form a suspended mounting structure. The springs have a predetermined compression stroke, such as 2-3 mm, so that when the intestinal peristalsis pressure increases, the springs compress and buffer, and the magnetic bead slightly shifts with the intestinal morphology, avoiding local stress concentration and thus reducing the risk of compression. Furthermore, the spring surface is coated with a polytetrafluoroethylene coating to make the movement of the magnetic bead smoother and avoid jamming.

[0033] According to an embodiment of the present invention, at least some of the magnetic beads incorporate miniature pressure sensors for real-time monitoring of intestinal contact pressure. A magnetic field adjustment module, including a micro battery and an electromagnetic coil surrounding the annular matrix, is disposed within the annular matrix. When the contact pressure exceeds a set threshold, for example, greater than 30 mmHg, the magnetic field adjustment module dynamically reduces the magnetic force intensity to maintain the contact pressure within a safe range.

[0034] Furthermore, the magnetic field adjustment module also includes a Bluetooth module for transmitting contact pressure values ​​and receiving external pressure control commands.

[0035] According to embodiments of the present invention, an elastic buffer layer is further included, located on the inner wall of the annular substrate, covering the outer side of the magnetic bead assembly, and bonded to the annular substrate with epoxy adhesive. Exemplarily, the elastic buffer layer is made of silicone rubber with a thickness of 0.5-0.8 mm. The surface of the buffer layer has annular grooves to store intestinal mucus, thereby reducing friction between the magnetically controlled ceramic bead ring and the intestinal wall. Simultaneously, the moisture in the mucus can reduce the rate of magnetic attenuation of the magnetic beads.

[0036] Example 1: This embodiment provides a detailed description of the fabrication method for gradient magnetic bead components. For example... Figure 3 As shown, the process includes the following steps: S11, magnetic powders were mixed in a mass ratio of NdFeB:Fe3O4=3:1, 0.5% zinc stearate lubricant was added, and the mixture was pressed into a magnetic bead blank with a diameter of 3mm under a pressure of 100MPa. After vacuum sintering at 1100℃ for 2 hours, the core was obtained by cooling and polishing.

[0037] S12 uses a thermal spraying method to coat the core surface with zirconia ceramic at a spraying temperature of 1500℃ and a coating thickness of 0.3mm. After that, it is sandblasted to achieve a surface roughness of Ra0.3μm.

[0038] S13, prepare hydroxyapatite sol, mix Ca(NO3)2 and (NH4)2HPO4 at Ca / P=1.67, immerse ceramic-coated magnetic beads in the sol, pull at a speed of 5mm / s, and sinter at 600℃ for 1 hour to form an HA coating with a thickness of 80nm.

[0039] S14. Drill a hole in the center of the magnetic bead, insert a miniature pressure sensor, and fix it with epoxy glue; weld one end of three titanium alloy springs to the outside of the magnetic bead, and use the other end of the springs to connect to the reserved interface of the annular substrate.

[0040] S15. Coat the inside of the magnetic beads (the side facing the intestine) with sodium alginate-chitosan composite gel and cure at room temperature for 30 minutes to form a mucosal repair sustained-release layer.

[0041] Example 2: This embodiment provides a detailed description of the overall assembly process of the magnetically controlled ceramic bead ring. For example... Figure 4 As shown, the process includes the following steps: S21, PEEK granules are injection molded into a ring with an inner diameter of 2.8cm, an outer diameter of 4cm, and a thickness of 1.8mm. The ring has a reserved battery compartment, a magnetic field adjustment module mounting slot, and a magnetic bead connection interface.

[0042] S22 embeds a micro battery and a magnetic field adjustment module (including an electromagnetic coil and a Bluetooth chip) inside the substrate, and connects them to the pressure sensor of the magnetic bead through wires. The coil is wound inside the substrate with 500 turns and a wire diameter of 0.05mm. The other end of the magnetic bead spring is connected to the reserved interface of the annular substrate.

[0043] S23, cut silicone rubber into rings with a thickness of 0.6mm and an inner diameter of 3cm, process annular grooves on the surface, and bond it to the inner wall of the substrate with epoxy adhesive to cover the area where the magnetic field adjustment module and spring are connected.

[0044] S24, after assembly, magnetic parameters, pressure monitoring accuracy and sealing performance were tested in a simulated intestinal environment.

[0045] It is understood that, in the above embodiments of the present invention, apart from the basic structure of the annular substrate and the magnetic field adjustment module and magnetic bead assembly installed therein, other designs are optional, and the combination of these optional designs is not limited unless there is a conflict. Furthermore, it is understood that the materials used in all parts of the ceramic bead ring, especially the materials of the components in contact with internal organs, are all medical-grade materials.

[0046] Testing showed that after 30 days at 37℃, the magnetic induction intensity inside the magnetic beads did not significantly decrease. Simulating intestinal peristalsis pressure of 20-80 mmHg, the magnetic field adjustment module stabilized the contact pressure at 25 mmHg within 10 seconds without overpressure. When mushy feces were injected into the simulated intestine, there was no leakage after 24 hours in a closed state. Co-culturing the magnetic bead extract with L929 cells showed a cell viability of ≥95%. Implanting magnetically controlled ceramic bead rings into a rabbit intestinal stoma model and observing the mucosal tissue 14 days later showed no redness or ulceration, and the concentration of the inflammatory factor (IL-6) was reduced by 60% compared to the control group.

[0047] After the stoma has healed and stabilized post-surgery, the magnetically controlled ceramic bead ring is implanted along the stoma axis under local anesthesia using a specialized implanter. Following implantation, the magnetic parameters are calibrated via a mobile app or dedicated device, setting the initial mucosal contact pressure threshold. The gradient magnetic bead assembly automatically adheres, reducing the stoma diameter to 0.3 cm, achieving closure and preventing leakage. When the patient needs to defecate, a defecation command is sent via the external controller. This activates the magnetic field adjustment module, generating a reverse magnetic field in the electromagnetic coil, reducing the surface magnetic induction intensity of the magnetic beads (e.g., to 300-500 Gs). This weakens the magnetic adhesion, restoring the stoma diameter to 2-3 cm, allowing the patient to defecate normally. After defecation, the controller sends a closure command, the reverse magnetic field closes, the magnetic beads regain their gradient magnetic force, and the stoma closes again.

[0048] The external controller receives contact pressure data from the built-in pressure sensor of the magnetic bead in real time. When the contact pressure is >30mmHg or <20mmHg, it automatically issues an audible and visual alarm to prompt the patient to adjust the magnetic parameters.

[0049] Thirty patients aged 45-65 years were selected after colostomy, including 22 patients after colorectal cancer surgery and 8 patients after intestinal obstruction surgery. All patients underwent implantation of the magnetically controlled ceramic bead ring of this invention and were followed up for 3 months. Results showed that one month post-surgery, the fecal leakage rate decreased to 3%, and the skin irritation rate was 4%. Three months post-surgery, the patient satisfaction rate for spontaneous defecation control reached 93%. Furthermore, none of the 30 patients experienced serious complications such as mucosal bleeding or perforation; only two patients experienced mild mucosal redness and swelling (which was relieved after adjusting the magnetic parameters), significantly lower than existing implantable colostomy control devices.

[0050] This invention designs a magnetic bead assembly adapted to the intestinal environment and utilizes a magnetic field adjustment module to regulate the gradient magnetic force of the magnetic beads to achieve dynamic closure of the enterostomy, ensuring both airtightness and avoiding intestinal compression. Simultaneously, this invention improves biocompatibility by optimizing the magnetic bead material and surface modification, integrates the sustained-release function of traditional Chinese medicine, alleviates intestinal mucosal irritation, and reduces the risk of inflammation and bleeding.

[0051] Therefore, the present invention can improve the convenience and tolerability of patients and improve their postoperative quality of life.

[0052] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of the invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the appended claims.

Claims

1. A magnetically controlled ceramic bead ring for controlling defecation in an enterostomy, comprising an annular substrate and a magnetic bead assembly installed in the annular substrate; the magnetic bead assembly comprises multiple magnetic beads uniformly disposed along the circumferential direction on the inner annular sidewall of the annular substrate, with adjacent magnetic beads having opposite magnetic polarities to form a closed annular magnetic field with magnetic attraction concentrated in the central region of the stoma; wherein, A magnetic field adjustment module is provided within the annular matrix to generate a magnetic field opposite to the direction of the annular closed magnetic field, so as to control the diameter of the enterostomy by changing the magnetic adsorption force.

2. The magnetically controlled ceramic bead ring according to claim 1, wherein, Each magnetic bead is mounted on a ring-shaped base by multiple titanium alloy springs.

3. The magnetically controlled ceramic bead ring according to claim 1, wherein, The magnetic beads are made of composite materials, including a core, a core coating layer and a surface layer. The core is made of neodymium iron boron ferrite composite magnetic material, the core coating layer is a zirconium oxide ceramic shell, and the surface layer is a hydroxyapatite (HA) coating on the surface of the ceramic shell.

4. The magnetically controlled ceramic bead ring according to claim 3, wherein, The surface layer on the side of the magnetic bead facing the center of the annular matrix also includes a mucosal repair sustained-release layer, which uses sodium alginate-chitosan composite gel, loaded with growth factors and traditional Chinese medicine extracts, and has micropores on its surface.

5. The magnetically controlled ceramic bead ring according to claim 1, wherein, The surface magnetic induction intensity of a single magnetic bead increases linearly from the inner circle to the outer circle along the radial direction of the annular substrate.

6. The magnetically controlled ceramic bead ring according to claim 1, wherein, The magnetic field conditioning module includes a micro battery and an electromagnetic coil surrounding a ring-shaped substrate. At least some of the magnetic beads have built-in micro pressure sensors, which are connected to the magnetic field conditioning module.

7. The magnetically controlled ceramic bead ring according to claim 2, wherein, The magnetic field adjustment module includes a Bluetooth module.

8. The magnetically controlled ceramic bead ring according to claim 1, wherein, It also includes an elastic buffer layer located on the inner wall of the annular substrate, covering the outer side of the magnetic bead assembly, and bonded to the annular substrate with epoxy adhesive.

9. A method for controlling defecation through an enterostomy using the magnetically controlled ceramic bead ring according to any one of claims 1-8, wherein when a defecation command is received, the magnetic field adjustment module is activated to generate a reverse magnetic field, thereby reducing the surface magnetic induction intensity of the magnetic beads, weakening the magnetic adsorption force, and increasing the diameter of the enterostomy to an open state to allow the patient to defecate normally; when a closing command is received, the magnetic field adjustment module closes the reverse magnetic field, the magnetic beads regain their magnetic adsorption force, and the diameter of the enterostomy decreases back to a closed state.

10. The method according to claim 9, wherein, The instructions are sent via an external controller.

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