Device for multi-mode rehabilitation treatment of swallowing dysfunction

Abstract

The utility model provides a device for swallowing dysfunction multi-mode rehabilitation treatment, which comprises a multi-chamber elastic tube (10), a stimulation bag (20), an infusion interface (30), a stimulation electrode, an electrode lead (405) and an electrical stimulation interface (406), and is characterized in that at least two channels are arranged in the multi-chamber elastic tube (10); the open end of the stimulation bag (20) is combined on the outer wall of the head end of the multi-cavity elastic tube (10) in a sealed mode, and an inner cavity of the stimulation bag (20) is communicated with a refrigerant injection port (104) in the head of a first channel (101) in the multi-cavity elastic tube (10). According to the device, intervention methods of various modes such as cold stimulation, electrical stimulation or balloon dilatation are achieved in one device, the treatment effect better than that of a single treatment means is improved, the integration level of rehabilitation treatment materials for dysphagia is improved, and the convenience of preparation of the rehabilitation treatment materials is improved. Meanwhile, the feed can be left in the esophagus of a patient for enteral nutrition support.

Description

Technical Field

[0001] The present disclosure relates to a device for multi-modal rehabilitation treatment of dysphagia, belonging to the fields of medical devices and rehabilitation supplies. Background Art

[0002] Dysphagia refers to the inability to safely and effectively transport food from the oral cavity to the stomach to obtain sufficient nutrition and moisture, resulting in difficulties in eating. The causes of dysphagia include neurogenic, structural, and psychogenic dysphagia. Neurogenic dysphagia is a high-incidence disease in recent years. It is reported that the incidence and prevalence of dysphagia increase with age. Among them, the prevalence in people over 50 years old is 5.5%-8%, the prevalence of dysphagia in the acute stage of stroke patients is about 42%, the prevalence of brainstem lesions can reach 80%, and the incidence of oropharyngeal dysphagia in patients after radiotherapy for nasopharyngeal carcinoma can also be as high as 70%-80%. The most direct adverse consequence of dysphagia is malnutrition and insufficient moisture, and it may also lead to the risk of aspiration and aspiration pneumonia, and in severe cases, it can endanger life.

[0003] In view of the multiplicity and serious adverse consequences of dysphagia, domestic and foreign scientific research workers seek to provide precise and individualized intervention programs for dysphagia patients to improve the swallowing function of patients, reduce the risks of aspiration pneumonia and malnutrition, and improve their quality of life. The present disclosure provides a device and method for multi-modal rehabilitation treatment of dysphagia, providing a more optimized new rehabilitation treatment technology for medical staff and patients. Summary of the Invention

[0004] The present disclosure proposes a device and method for multi-modal rehabilitation treatment of dysphagia.

[0005] A device for multi-modal rehabilitation treatment includes a multi-chamber elastic tube, a stimulation bladder, an infusion interface, a stimulation electrode, an electrode wire, and an electrical stimulation interface.

[0006] The multi-chamber elastic tube is a flexible tube made of medical polymer materials, and the medical polymer materials used include but are not limited to soft polyvinyl chloride, silicone rubber, polyurethane, and nylon.

[0007] At least 2 channels are provided inside the multi-chamber elastic tube. For example, 4 channels are provided inside the multi-chamber elastic tube, which are respectively marked as the first channel, the second channel, the third channel, and the fourth channel.

[0008] The multi-chamber elastic tube is a circular or oval tube with an outer diameter between 8Fr and 22Fr, and can be inserted through the nasal cavity or oral cavity to reach near the pharynx of the patient.

[0009] The stimulation bladder is an elastic cavity made of a thin and light medical polymer material. The medical polymer materials used include, but are not limited to, soft polyvinyl chloride, silicone rubber, polyurethane, and nylon.

[0010] The shapes of the stimulation bladder include spherical, pear-shaped, gourd-shaped, heart-shaped, and cylindrical, and the volume of the stimulation bladder is between 10 ml and 50 ml. According to the patient's individuality, the shape and volume of the stimulation bladder should be such that after the stimulation bladder is inflated with water, the outer periphery of the stimulation bladder can comfortably contact the inner side of the oral cavity or the outer periphery of the pharynx.

[0011] The open end of the stimulation bladder is hermetically combined on the outer wall of the head end of the multi-chamber elastic tube, and the inner cavity of the stimulation bladder is communicated with the refrigerant injection port at the head of the first channel in the multi-chamber elastic tube.

[0012] The infusion interface is arranged at the tail end of the first channel in the multi-chamber elastic tube. The infusion interface is communicated with the first channel in the multi-chamber elastic tube by an infusion extension tube. The infusion interface is a closable port for inputting or extracting refrigerant or gas into the stimulation bladder. The infusion interface includes, but is not limited to, a one-way valve, a Luer connector, and a sealing cap. The infusion interface is connected to the output port of the refrigerant infusion device, and the refrigerant infusion device includes any one of a syringe, a syringe pump, an infusion pump, or a medical refrigeration device.

[0013] The stimulation electrodes are distributed in pairs and are arranged on the outer periphery of the head end of the multi-chamber elastic tube. At least one pair of stimulation electrodes should be set, marked as the first electrode and the second electrode, and the distance between the first electrode and the second electrode is 5 mm - 20 mm. For another example, according to the need to stimulate multiple parts simultaneously, two pairs of stimulation electrodes are set. The first pair of stimulation electrodes is marked as the first electrode and the second electrode, and the second pair of stimulation electrodes is marked as the third electrode and the fourth electrode.

[0014] The stimulation electrodes are made of a conductive material, including, but not limited to, conductive metal and conductive silicone rubber. The shapes of the stimulation electrodes include ring electrodes, sheet electrodes, and flexible printed electrodes.

[0015] In one embodiment, the stimulation electrodes are flexible electrodes, and the flexible stimulation electrodes are respectively arranged on the outer periphery of the stimulation bladder. For example, one pair of stimulation electrodes is respectively arranged on the left and right of the outer periphery of the stimulation bladder, and the distance between each pair of stimulation electrodes is 5 mm - 20 mm.

[0016] The electrode wires are conventional two-core insulated wires, and the electrode wires are arranged in the second channel inside the multi-chamber elastic tube. For example, the head of the first core of the electrode wire is connected to the first electrode, and the head of the second core of the electrode wire is connected to the second electrode.

[0017] The electrical stimulation interface is an interface for quickly connecting the electrode wires to the output port of the electrical stimulation device. The types of the electrical stimulation interface include, but are not limited to, USB interfaces, DC connectors, and audio connectors.

[0018] A method of multimodal rehabilitation therapy, comprising:

[0019] Insert a multi-chamber elastic tube into the pharynx or the inner side of the oral cavity through the oral cavity or nasal cavity, and inject a refrigerant into the infusion interface. The refrigerant includes pre-cooled sterile water or physiological saline, and cold stimulation is performed on the root of the tongue, the palate or the pharynx.

[0020] The input refrigerant includes sterile water pre-cooled to 0 °C or physiological saline at -1.9 °C to 0.5 °C. The pre-cooling method includes pre-freezing or refrigerating sterile water or physiological saline, and using a syringe or an infusion pump to transport it to the stimulation sac at the infusion interface.

[0021] It further includes that the infusion interface is directly connected to the refrigeration device. After the refrigeration device cools the sterile water or physiological saline, it is transported to the stimulation sac.

[0022] When the infusion interface is directly connected to the refrigeration device, a temperature sensor is also provided in the head of the multi-chamber elastic tube or inside the stimulation sac. The temperature sensor is connected to the data interface of the refrigeration device through a temperature measurement wire and a temperature measurement interface. The temperature measurement wire is arranged in the 3rd channel of the multi-chamber elastic tube, and the temperature measurement interface is arranged at the tail of the temperature measurement wire. The temperature sensor dynamically monitors the temperature of the refrigerant in the stimulation sac and feeds it back to the control system of the refrigeration device. After the temperature of the refrigerant rises, the refrigeration device actively withdraws the refrigerant in the stimulation sac and injects new refrigerant, and circulates automatically in this way, reducing the labor intensity of manual injection or extraction.

[0023] Since patients with swallowing dysfunction cannot eat normally, therefore, it is a normal nursing operation to indwell a gastrointestinal tube for enteral nutrition support for such patients. In order to improve the integration level of medical consumables, further, the gastrointestinal tube is combined with the multi-chamber elastic tube. The multi-chamber elastic tube extends from the front end upstream of the stimulation sac until it can reach the patient's gastrointestinal tract. The 4th chamber of the multi-chamber elastic tube is used as the nutrition delivery chamber to achieve enteral nutrition support. For example, the front end of the multi-chamber elastic tube is extended by 50 cm, the 4th channel is added as the nutrition delivery chamber, and the tail of the 4th channel is connected to an extension tube and a closed valve.

[0024] A method of multimodal rehabilitation therapy, comprising:

[0025] Insert the multi-chamber elastic tube into the pharynx or the inner side of the oral cavity through the oral cavity or nasal cavity, and connect the infusion interface to the output port of the gas output device. The gas output device includes any one of a syringe, a syringe pump, a medical rehabilitation device or an air pump. The gas output device pulsingly inflates, maintains, inhales and retracts the stimulation sac, then inflates, maintains, inhales and retracts again, and so on for repeated intervention, pulling the cricopharyngeal muscle by changing the balloon diameter, activating the neural network regulation of the brainstem and the brain, and restoring the swallowing function.

[0026] A method of multimodal rehabilitation therapy further includes:

[0027] A flexible electrode is arranged on the outer wall of the stimulation sac. After a multi-chamber elastic tube is inserted into the pharynx or the inner side of the oral cavity through the oral cavity or nasal cavity, the infusion interface is connected to the refrigerant input device, and the electrical stimulation interface of the flexible electrode is connected to the electrical stimulation device. After injecting the refrigerant, the electrical stimulation device is turned on to perform cold stimulation and sac dilation multi-modal intervention treatment on the treatment site, improving the treatment effect and intervention efficiency.

[0028] Obviously, with the continuous improvement of the integration level of medical electronic devices, a medical device that not only has the functions of refrigerant preparation and infusion control but also has the function of electrical stimulation is a conventional and achievable technology. For example, a multi-functional swallowing function rehabilitation device is provided, and a device of the present disclosure is used in combination with the multi-functional swallowing function rehabilitation device. Through programming control, automatic control of cold stimulation is performed, including the prefabricated temperature of the refrigerant, the input amount of the refrigerant, the temperature threshold to be extracted after the refrigerant is heated, the refrigerant circulation time, etc., and automatic control of electrical stimulation is performed by programming control, including the stimulation current intensity, stimulation frequency, and stimulation duration.

[0029] A device of the present disclosure is used in combination with a multi-functional swallowing function rehabilitation device. The flexible electrode is arranged on the outer wall of the stimulation sac. The refrigerant is injected or extracted in a pulsed manner through programming control, and the injection amount and injection interval time can be set independently. For example, 30 ml of refrigerant is injected quickly, and after maintaining for 10 seconds, it is quickly extracted, and then injected again, extracted... to make the stimulation sac expand and contract, and so on. The refrigerant stimulates the treatment site in a pulsed manner.

[0030] Furthermore, while the refrigerant in the stimulation sac stimulates the treatment site in a pulsed manner, the multi-functional swallowing function rehabilitation device controls the electrical stimulation through programming. When the stimulation sac injects refrigerant and expands and maintains, electrical stimulation is applied; when the stimulation sac extracts refrigerant and retracts, the electrical stimulation is paused, and so on, maximizing the contact area between the stimulation electrode and the treatment site, realizing synchronous stimulation of the upper palate and the root of the tongue, and multi-point stimulation of the periphery of the pharynx, and improving the intervention effect.

[0031] During the period when enteral nutrition support is required, the closed valve is opened, a syringe or an infusion pump is connected, and fluid nutritional drugs or foods are infused into the patient's gastrointestinal tract. After the infusion is completed, the closed valve is closed again.

[0032] The beneficial effects of the present disclosure are as follows: A device and method for multi-modal rehabilitation treatment are provided, which improve the integration degree of the rehabilitation treatment materials for dysphagia and the convenience of preparing the rehabilitation treatment materials. A variety of modal intervention methods such as cold stimulation, electrical stimulation, or sac dilation are realized in one device, increasing the treatment effect that is better than a single treatment method. At the same time, the present invention can be left in the patient's esophagus for enteral nutrition support. The device and method for multi-modal rehabilitation treatment proposed by the present disclosure, when combined with such a medical device, can further improve the efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Many aspects of the present disclosure can be better understood with reference to the following drawings, in which the components are not necessarily drawn to scale or shape. Instead, emphasis is placed on clearly illustrating the principles of the present disclosure. For a more intuitive representation of the technical features of the present disclosure, the stimulation sacs shown in the drawings are all drawn in the expanded state after injecting the refrigerant.

[0034] Figure 1 A schematic structural diagram according to the first embodiment of the present disclosure is depicted.

[0035] Figure 2 A schematic structural diagram according to the second embodiment of the present disclosure is depicted.

[0036] Figure 3 A schematic structural diagram according to the third embodiment of the present disclosure is depicted.

[0037] Multi-chamber elastic tube 10, first channel 101, second channel 102, third channel 103, refrigerant injection port 104, stimulation sac 20, infusion interface 30, infusion extension tube 301, first electrode 401, second electrode 402, third electrode 403, fourth electrode 404, electrode wire 405, electrical stimulation interface 406, temperature sensor 50, temperature measurement wire 501, temperature measurement interface 502, gastrointestinal tube 60, extension tube 601, closed valve 602 DETAILED DESCRIPTION OF THE EMBODIMENTS

[0038] The present invention will be specifically described below in conjunction with the drawings and embodiments

[0039] Example 1: An example of a technical method of using a ring electrode and arranging the electrode on the outer wall of the multi-chamber elastic tube 10 is given, and the specific process is described as follows:

[0040] 1. Material preparation

[0041] 1.1 As Figure 1 shown, an extrusion die for the multi-chamber elastic tube 10 is prepared, and the applicable material is medical soft polyurethane. The outer diameter of the multi-chamber elastic tube 10 is Fr16, and there are 3 channels inside. The inner diameter of the first channel 101 is 2.0 mm, the inner diameter of the second channel 102 is 1.0 mm, and the inner diameter of the third channel 103 is 1.0 mm. It is cut into short tubes with each length of 350 mm.

[0042] 1.2 An extrusion die for the infusion extension tube 301 is prepared, and the applicable material is medical soft polyurethane. The outer diameter is 1.9 mm, and it is cut into short tubes with each length of 100 mm.

[0043] 1.3 Fabricate the mold for the stimulation bladder 20, with the applicable material being medical soft polyurethane. Use the blow molding process to prepare the stimulation bladder 20. The stimulation bladder 20 is circular with a single-way opening, a wall thickness of 0.2 mm, and a volume of 30 ml.

[0044] 1.4 Prepare the annular electrode. Use a capillary tube extruded from 316 stainless steel, with a thickness of 0.1 mm and an inner diameter of 5.3. Cut it into rings with a height of 5 mm.

[0045] 1.5 The infusion interface 30 uses a spring one-way valve, and the interface inner diameter with the infusion extension tube 301 is 2.0 mm. The injection port can be matched and connected to the output port of a standard 20 ml or 50 ml syringe.

[0046] 1.6 The electrode wire 405 and the temperature measurement wire 501 both use insulated copper wires with an outer diameter of 0.8 mm. The impedance of the insulated copper wire does not exceed 100 ohms, and it is cut into short wires with each segment being 500 mm long.

[0047] 1.7 The temperature sensor 50 uses a 103K type small round head thermistor. The head of the temperature sensor 50 is encapsulated with epoxy resin insulation, and the lead wire is enameled wire. The maximum outer diameter of the head is 1.0 mm, the length is 2 mm, the minimum indication value is 0.1 °C, and the error does not exceed ±0.2 °C.

[0048] 1.8 The electrical stimulation interface 406 uses a standard mini-USB interface, and the temperature measurement interface 502 uses a standard 2.5 mm audio male head.

[0049] 2. Assembly process

[0050] 2.1 Weld the two lead wires of the temperature sensor 50 to the head ends of the temperature measurement wires 501 respectively, and weld the two stimulation electrodes to the head parts of the electrode wires 405 respectively.

[0051] 2.2 As Figure 1 shown, use a punching device to punch a 1 mm - 2 mm small hole on the tube wall of the first channel 101 of the multi-chamber elastic tube 10 at a distance of 10 mm from the head as the refrigerant injection port 104.

[0052] 2.3 As Figure 1 shown, use a punching device to punch 1 mm small holes on the tube walls of the second channel 102 of the multi-chamber elastic tube 10 at distances of 40 mm and 50 mm from the head respectively as the through holes for the electrode wires 405. Pass the electrode wires 405 of the first electrode 401 and the second electrode 402 through the two small holes respectively. After the electrode wires 405 penetrate the second channel 102, lead the rear ends of the electrode wires 405 to the tail of the multi-chamber elastic tube 10, and couple the ends of the electrode wires 405 with the electrical stimulation interface 406.

[0053] 2.4 As Figure 1As shown in the figure, the temperature measurement wire 501 on the temperature sensor 50 penetrates through the third channel 103 of the multi-chamber elastic tube 10. The temperature measurement wire 501 is led out to the tail of the multi-chamber elastic tube 10, and the end of the temperature measurement wire 501 is coupled with the temperature measurement interface 502.

[0054] 2.5 Put the stimulation bladder 20 onto the head of the multi-chamber elastic tube 10, and use medical glue to hermetically bond the opening of the stimulation bladder 20 to the outer wall of the multi-chamber elastic tube 10.

[0055] 2.6 Use medical glue to hermetically bond the head of the infusion extension tube 301 to the first channel 101 of the multi-chamber elastic tube 10, and hermetically bond the tail of the infusion extension tube 301 to the infusion interface 30.

[0056] 3. Check that there should be no leakage at each fixed connection part, and package it with a medical dialysis bag, and keep it for use after sterilization.

[0057] Example 2: An example of a technical method of using a flexible electrode and arranging the flexible stimulation electrode on the outer wall of the stimulation bladder 20

[0058] 1. Use copper foil of purple copper with a wall thickness of 0.02 mm, cut it into rectangles with a size of 10 mm × 4 mm for each piece as the flexible stimulation electrode.

[0059] 2. Weld the prepared flexible stimulation electrode to the electrode wire 405, and the welding point should be flat, smooth and free of burrs.

[0060] 3. As Figure 2 shown in the figure, use medical-grade glue to paste the flexible stimulation electrodes on the outer periphery of the stimulation bladder 20 respectively. The first electrode 401 and the second electrode 402 are on the left side, with an upper and lower spacing of 8 mm; the third electrode 403 and the fourth electrode 404 are on the right side, with an upper and lower spacing of 8 mm.

[0061] 4. Refer to the assembly process steps 2.3 - 2.6 described in Example 1 to complete other processes, which will not be elaborated here one by one.

[0062] Example 3: An example of a technical method of adding a gastrointestinal tube 60 on the basis of Example 1 or Example 2

[0063] 1. As Figure 3 shown in the figure, open an extrusion die for the multi-chamber elastic tube 10, and the applicable material is medical soft polyurethane. The outer diameter of the multi-chamber elastic tube 10 is Fr22, and there are 4 channels inside. The inner diameter of the first channel 101 is 2.0 mm, the inner diameter of the second channel 102 is 1.0 mm, the inner diameter of the third channel 103 is 1.0 mm, and the inner diameter of the fourth channel is 2.5 mm. Cut it into short tubes with a length of 900 mm for each piece.

[0064] 2. Extrusion die for the extension tube 601, with the applicable material being medical soft polyurethane. The outer diameter is 2.4 mm, and it is cut into short tubes with each length of 90 mm.

[0065] 3. The fourth channel serves as the extended cavity of the gastrointestinal tube 60. Medical glue is used to bond the tail of the fourth channel to the extension tube 601, and the tail of the extension tube 601 is hermetically combined with the closed valve 602. The closed valve 602 is a spring one-way valve with self-locking.

[0066] 4. Preparation of components such as the stimulating electrode and the stimulating capsule 20, referring to Example 1 or Example 2.

[0067] The above-mentioned drawings and embodiments are only used to illustrate the technical solutions of the present invention rather than to limit them. The serial numbers such as the first, the second, the third, the fourth, etc. are only used to distinguish different parts rather than specific sequences, and the left and right, up and down, front end, tail, etc. are only for expressing the spatial distribution rather than the limit positions. Although the present invention has been described in detail with reference to the preferred embodiments, those of ordinary skill in the art should understand that the technical solutions of the present invention can be modified or equivalently replaced without departing from the purpose and scope of the technical solutions of the present invention, and they should all be covered by the scope of the claims of the present invention, without constituting any limitation to the protection scope of the present invention.

Claims

1. A device for multi-modal rehabilitation treatment of dysphagia, characterized in that It consists of a multi-chamber elastic tube (10), a stimulation bladder (20), an infusion interface (30), stimulation electrodes, an electrode wire (405), and an electrical stimulation interface (406). The multi-chamber elastic tube (10) is a flexible tube made of a medical polymer material, and at least two channels are provided inside the multi-chamber elastic tube (10). The stimulation bladder (20) is an elastic cavity made of a thin medical polymer material. The open end of the stimulation bladder (20) is hermetically combined on the outer wall of the head end of the multi-chamber elastic tube (10). The inner cavity of the stimulation bladder (20) is communicated with the refrigerant injection port (104) at the head of the first channel (101) inside the multi-chamber elastic tube (10). The stimulation electrodes are distributed in pairs and are arranged on the outer periphery of the head end of the multi-chamber elastic tube (10).

2. The device for multi-modal rehabilitation treatment of dysphagia according to claim 1, wherein: The chamber elastic tube is a circular or oval tube with an outer diameter between 8Fr and 22Fr.

3. The device for multimodal rehabilitation treatment of dysphagia according to claim 1, characterized in that: The shape of the stimulation bladder (20) includes spherical, pear-shaped, gourd-shaped, heart-shaped, and cylindrical, and the volume of the stimulation bladder (20) is between 10 ml and 50 ml.

4. The device for multi-modal rehabilitation treatment of dysphagia according to claim 1, characterized in that: The infusion interface (30) is arranged at the tail end of the first channel (101) inside the multi-chamber elastic tube (10). The infusion interface (30) is communicated with the first channel (101) inside the multi-chamber elastic tube (10) by an infusion extension tube (301). The infusion interface (30) is a closable port for inputting or extracting refrigerant or gas into the stimulation bladder (20).

5. A device for multimodal rehabilitation treatment of dysphagia according to claim 1, characterized in that: The stimulation electrodes are flexible electrodes, and the flexible stimulation electrodes are respectively arranged on the outer periphery of the stimulation bladder (20).

6. The device for multi-modal rehabilitation therapy for dysphagia according to claim 1, characterized in that: A temperature sensor (50) is also provided inside the head of the multi-chamber elastic tube (10) or the stimulation bladder (20). The temperature sensor (50) is connected to the data interface of the refrigeration equipment through a temperature measurement wire (501) and a temperature measurement interface (502).

7. A device for multi-modal rehabilitation therapy for dysphagia according to claim 1, characterized in that, The gastrointestinal tube (60) is combined with the multi-chamber elastic tube (10). The multi-chamber elastic tube (10) extends from the front end upstream of the stimulation bladder (20) until it can reach the patient's gastrointestinal tract. The fourth chamber of the multi-chamber elastic tube (10) is used as a nutrition delivery chamber.

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