Customizable and adjustable expansion and vibration assisting 3D printing nasal cavity supporting device

Abstract

The invention relates to a customizable and adjustable expansion and vibration assisting 3D printing nasal cavity supporting device which comprises a hollow tubular supporting main body made of a biocompatible material through 3D printing, and the front end of the hollow tubular supporting main body is in a round blunt shape; the multi-section expansion mechanism comprises at least one expansion unit arranged along the peripheral side of the supporting main body; the expansion unit is of an annular structure, a functional element made of a shape memory material is anchored in the expansion unit, and the expansion unit is configured to be capable of radially expanding when activated; the vibration and positive pressure auxiliary module is arranged at the tail end of the supporting body and used for generating vibration and / or positive expiratory pressure. Multi-section adjustable expansion and vibration / positive pressure assistance are combined, and the personalized 3D printing and shape memory material technology is applied, so that serious nasal obstruction can be solved, and a patient can still smoothly exhale with the nose when rhinitis attacks.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a customizable, adjustable, expandable, and vibration-assisted 3D-printed nasal support device. Background Technology

[0002] Nasal congestion is a common symptom of nasal diseases such as rhinitis and turbinate hypertrophy. Currently, commonly used clinical methods for relief include physical dilation (such as nasal strips and rigid nasal dilators) and drug treatment (such as nasal drops). However, these traditional methods have significant limitations: physical dilators are fixed in size and non-adjustable, making them unsuitable for different patients or different stages of the same patient's disease; while long-term use of drugs can easily lead to dependence and has a limited range of action, proving ineffective for refractory nasal congestion.

[0003] Some tubular nasal support devices have emerged in the existing technology, but their functions are limited, mainly providing static support and unable to achieve dynamic adjustment. They also lack auxiliary therapeutic functions, and their effects on patients with severe nasal congestion are unsatisfactory.

[0004] Studies have shown that acoustic vibrations at specific frequencies can significantly increase the concentration of nitric oxide in the nasal cavity, thereby promoting ciliary movement and enhancing mucus clearance. Simultaneously, moderate positive expiratory pressure helps open collapsed nasal passages. Combining acoustic vibrations, positive expiratory pressure, and adjustable expansion support holds promise as a more effective solution for relieving nasal congestion.

[0005] Therefore, there is an urgent need in the field for a comprehensive nasal support device that can be customized according to the patient's nasal anatomy, has adjustable support strength, and can provide vibration and positive pressure-assisted therapy. Summary of the Invention

[0006] The purpose of this invention is to overcome the shortcomings of existing technologies and provide a customizable, adjustable, expandable 3D-printed nasal support device with vibration and positive pressure assistance functions. This device integrates multiple functions such as multi-segment adjustable expansion, acoustic vibration, positive expiratory pressure, drug sustained release, and physiological parameter monitoring, aiming to provide a safe, efficient, and comfortable nasal support device for patients with nasal congestion of different conditions.

[0007] To achieve the above objectives, the present invention provides the following solution:

[0008] A customizable, adjustable, expandable, and vibration-assisted 3D-printed nasal support device, comprising:

[0009] A hollow tubular support body made of biocompatible material through 3D printing has a rounded front end to facilitate insertion and reduce the risk of tissue damage.

[0010] A multi-segment expansion mechanism includes at least one expansion unit disposed along the periphery of the support body; the expansion unit is a ring structure with an inherent shape memory segment anchored inside, and the expansion unit is configured to expand radially when activated.

[0011] A vibration and positive pressure assist module is disposed at the tail end of the support body for generating vibration and / or positive expiratory pressure.

[0012] Furthermore, the shape memory segment is a nickel-titanium alloy wire or a shape memory polymer; and an electrode is embedded in the shape memory segment, the electrode being configured to heat the shape memory segment after being energized to activate its expansion.

[0013] Furthermore, the multi-segment expansion mechanism also includes at least one mechanical adjustment component; the mechanical adjustment component includes an elastic membrane covering the periphery of the support body, and at least one connecting rod assembly disposed inside the elastic membrane and driven by the internal mechanism of the support body;

[0014] Furthermore, the connecting rod assembly includes: two rotatably connected connecting rods, one of which is rotatably connected to the support body; and a slidably disposed motion ring within the support body, which is rotatably connected to the other connecting rod via a connecting block passing through a groove in the side wall of the support body.

[0015] The supporting body is equipped with a drive mechanism that drives the motion ring to slide.

[0016] The connecting rod assembly is configured to lift the elastic membrane when driven, thereby achieving radial expansion.

[0017] Furthermore, the drive mechanism includes:

[0018] A screw that is rotatably connected to the support body;

[0019] A connecting frame fixedly connected to the moving ring, wherein the screw passes through the connecting frame and is threaded therewith;

[0020] A miniature stepper motor for driving the screw to rotate.

[0021] Specifically, the vibration and positive pressure auxiliary module includes:

[0022] The vibration unit is a miniature electromagnetic loudspeaker or piezoelectric vibrator that is fixedly embedded in the inner wall of the support body;

[0023] The exhalation positive / oscillating one-way valve is a flutter valve or a micro turbine located at the tail end of the support body;

[0024] A controller is used to control the operating parameters of the vibration unit.

[0025] Furthermore, it also includes: a drug sustained-release and humidification component, which includes micropores and / or drug compartments disposed on the support body for sustained drug release and maintaining local humidity.

[0026] Furthermore, it also includes: a safety component, which includes a flexible limiting wing fixed to the front end of the support body, and / or a pull-back rope or safety ring disposed at the rear end of the support body.

[0027] Furthermore, the support body also integrates a sensor group, which includes one or more of a pressure sensor, a flow sensor, and a temperature and humidity sensor; the rear end of the support body is also provided with a wireless communication module for transmitting sensor data to external devices.

[0028] A method for manufacturing a customizable, adjustable, expandable, and vibration-assisted 3D-printed nasal support device includes the following steps:

[0029] S1. Obtain anatomical data of the patient's nasal cavity through medical imaging scans;

[0030] S2. Parametric modeling is performed based on anatomical structure data to generate a customized 3D model of the supporting structure;

[0031] S3. Using multi-material 3D printing technology, the support body and expansion unit are integrally formed, wherein the shape memory segment is anchored in the expansion unit during the printing process;

[0032] S4. Integrate the vibration and positive pressure auxiliary module and sensor group within the support body.

[0033] The beneficial effects of this invention are:

[0034] The acoustic vibration and positive expiratory pressure of this invention can significantly increase peak nasal inspiratory flow and reduce nasal congestion scores by increasing nasal nitric oxide, promoting ciliary movement and mucus discharge. Compared with single support, it can accelerate the relief of severe nasal congestion and improve the efficiency of nasal congestion relief.

[0035] Combining 3D customized dimensions and multi-material partitioned structure, it adapts to the nasal cavity morphology and pathological conditions of different groups of people.

[0036] Shape memory self-expanding reduces forceful manipulation; hydrophilic coating and soft wings reduce friction; positive pressure / vibration is controlled within a safe range, making it easily tolerated by patients. The synergistic combination of support, vibration, positive pressure, drug delivery, and data monitoring improves nasal congestion and mucosal inflammation.

[0037] By combining multi-segment adjustable expansion with vibration / positive pressure assistance, and utilizing personalized 3D printing and shape memory material technology, this invention can resolve severe nasal congestion, allowing patients to breathe smoothly through their nose even during rhinitis flare-ups. The introduction of these integrated functions not only enhances the technological sophistication but also improves the relief effect and commercial value. Attached Figure Description

[0038] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0039] Figure 1 This is a front view of the 3D-printed nasal cavity support device of the present invention;

[0040] Figure 2 This is a schematic diagram of the 3D-printed nasal cavity support device of the present invention;

[0041] Figure 3 for Figure 2 A magnified view of a section at point A in the middle;

[0042] The figure shows: 1. Support body; 2. Ring structure; 3. Elastic membrane; 4. Connecting rod; 5. Motion ring; 6. Through groove; 7. Screw; 8. Connecting frame; 9. Vibration unit; 10. Drug sustained release and humidification component; 11. Limiting wing; 12. Wireless communication module. Detailed Implementation

[0043] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0044] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0045] In the description of this invention, it should be understood that the terms "longitudinal", "lateral", "up", "down", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this invention, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention.

[0046] like Figure 1-3 As shown, the present invention provides a customizable, adjustable, expandable, and vibration-assisted 3D-printed nasal cavity support device, including...

[0047] Support body 1 is a hollow tubular composite material, 3D printed from biocompatible material with a soft front end, a medium-hard middle section, and a relatively rigid rear end, to adapt to different nasal cavity locations. The front end of support body 1 is rounded.

[0048] A multi-segment expansion mechanism includes at least one expansion unit disposed along the periphery of the support body 1; the expansion unit is a ring structure 2, which has an inherent shape memory segment anchored inside, and the expansion unit is configured to expand radially when activated; the shape memory segment is an element made of shape memory material, such as nickel-titanium alloy wire or shape memory polymer, integrally formed with a flexible elastic material by multi-material 3D printing, and an electrode is also embedded in the shape memory segment, the electrode being configured to heat the shape memory material after being energized to activate its expansion.

[0049] Furthermore, 2-6 expansion units are arranged along the support body 1. The static outer diameter of the expansion unit and the mechanical adjustment component is 4mm-8mm, and the expansion size is 1.2-1.8 times the static size. It can automatically expand under body temperature or electric heating, and gradually expands while keeping the channel open when worn.

[0050] Furthermore, the multi-segment expansion mechanism also includes at least one mechanical adjustment component; the mechanical adjustment component includes an elastic membrane 3 covering the periphery of the support body 1, with both ends of the elastic membrane 3 fixedly connected to the support body 1, and a plurality of connecting rod groups arranged around the periphery of the support body 1, the plurality of connecting rod groups being located within the elastic membrane 3, the connecting rod groups being configured to lift the elastic membrane (3) when driven, thereby achieving radial expansion. Each connecting rod group includes two rotatably connected connecting rods 4, any one of the connecting rods 4 being rotatably connected to the support body 1, a motion ring 5 being slidably connected to the end of the other connecting rod 4 within the support body 1, a connecting block being fixedly connected to the periphery of the motion ring 5 corresponding to the connecting rod 4, and a through groove 6 for the connecting block to slide on the side wall of the support body 1, the connecting block passing through the through groove 6 and being rotatably connected to the corresponding connecting rod 4.

[0051] A vibration and positive pressure assist module, located at the tail end of the support body 1, is used to generate vibration and / or positive expiratory pressure.

[0052] Furthermore, the support body 1 is provided with a drive mechanism for driving the motion ring 5 to slide. The drive mechanism includes a screw 7 rotatably connected to the support body 1, a connecting frame 8 fixedly connected to the motion ring 5, and a micro stepper motor for driving the screw 7 to rotate. The screw 7 passes through the connecting frame 8 and is threadedly engaged with it.

[0053] A micro stepper motor drives the control screw 7 to rotate, which in turn drives the connecting frame 8, which is threaded with the screw 7, and the motion ring 5 fixed thereto to move horizontally. In turn, the motion ring 5 drives a connecting rod 4 to move, so that the connection between the two connecting rods 4 gradually rises, lifting the elastic membrane 3, thereby increasing the outer diameter and providing support.

[0054] Furthermore, an arc-shaped plate is rotatably installed at the connection point of the two connecting rods 4. The arc-shaped plate contacts the elastic membrane 3 to prevent the connection point of the two connecting rods 4 from damaging the elastic membrane 3 and from causing pain to the inner wall of the nasal cavity.

[0055] Furthermore, the vibration and positive pressure assist module includes a vibration unit 9, an expiratory positive / oscillatory one-way valve, and a controller. The vibration unit 9 is a miniature electromagnetic speaker or piezoelectric vibrator fixedly embedded in the inner wall of the support body 1. The expiratory positive / oscillatory one-way valve is a flutter valve or miniature turbine located at the tail end of the support body 1, with an acoustic vibration frequency of 100-200Hz and a positive pressure range of 10-20cmH2O, promoting mucus discharge and relieving nasal congestion on a principle similar to the SinuSonic device. Utilizing the device of acoustic vibration and expiratory resistance, peak nasal inspiratory flow can be significantly increased, reducing the nasal congestion score from 5.8 to 2.9, with 95% of patients experiencing no discomfort.

[0056] The vibration unit 9 and the control circuit are integrated into the support body 1. The operating parameters of the vibration unit 9, including the vibration frequency and positive pressure, are wirelessly controlled by an external controller. The controller monitors the intranasal pressure and flow rate and automatically adjusts the vibration intensity and the heating time of the shape memory material to ensure comfort.

[0057] Furthermore, it also includes a drug sustained-release and humidification component 10, which includes micropores and / or drug reservoirs disposed on the support body 1. This is used to sustain drug release and control the amount and duration of drug release.

[0058] Furthermore, it also includes micro humidifiers or hydrophilic coatings to maintain local humidity and reduce mucosal dryness.

[0059] Furthermore, the support body 1 is equipped with safety components, including a limiting wing 11 fixedly installed at the front end of the support body 1 and a pull-back rope or safety ring located at the rear end of the support body 1. The limiting wing 11 is made of flexible material with a wingspan of 2-5mm, used to limit the insertion depth and improve the grip when removing the device. The pull-back rope or safety ring can prevent accidental aspiration during sleep.

[0060] Furthermore, the safety components also include a pressure relief setting, which sets safety limits on the maximum radial and positive pressure values ​​of the expansion unit to prevent overexpansion or excessive pressure.

[0061] Furthermore, the length of the support body 1 is 30mm-70mm. For adults, it is 55-70mm, and for children, it is 30-45mm. The front section of the support body 1 has an elliptical shape that gradually transitions to a circular shape at the rear to reduce airflow resistance. The dimensions are customized through scanning. The rounded front end facilitates insertion, and the rear end can extend to the nasopharynx and even the oropharynx.

[0062] Furthermore, the support body 1 also integrates a sensor group, including one or more of a pressure sensor, a flow sensor, and a temperature and humidity sensor. The tail end of the support body 1 is equipped with a wireless communication module 12 for controlling the pressure sensor, flow sensor, and temperature and humidity sensor, and optionally a Bluetooth module, for sending sensor data to external devices.

[0063] A method for manufacturing a customizable, adjustable, expandable, and vibration-assisted 3D-printed nasal support device includes the following steps:

[0064] S1. Obtain anatomical data of the patient's nasal cavity through medical imaging scans; obtain the patient's nasal cavity structure using CT / 3D scanning or optical scanning.

[0065] S2. Based on the anatomical structure data, perform parametric modeling to generate a customized three-dimensional model of the supporting structure;

[0066] Customized models are generated through parametric modeling, and then printed in sections using materials such as shape memory alloy wire, TPU / silicone rubber, and nylon / PEEK to form a partitioned structure that is soft at the front, medium hard in the middle, and relatively rigid at the back.

[0067] S3. Using multi-material 3D printing technology, the support body and expansion unit are integrally formed, wherein the shape memory segment is anchored in the expansion unit during the printing process;

[0068] The shape memory segment is embedded with a microelectrode, which can be heated by an external controller to induce deformation; after completion, it is treated with sandblasting, hydrophilic coating, and antibacterial coating.

[0069] S4. Integrate vibration and positive pressure auxiliary modules and sensor groups within the support body.

[0070] Sensor channels are reserved during the printing process, integrating pressure, flow, and temperature and humidity sensors. Data is transmitted via Bluetooth and used to drive the vibration and expansion units.

[0071] A method for relieving nasal congestion using a customizable, adjustable, expandable, and vibration-assisted 3D-printed nasal support device includes: lubricating and inserting the device into the limiting wing 11; adaptively expanding the expansion unit; activating the vibration unit 9 and generating positive pressure by gently exhaling to expel mucus from the flutter valve; adjusting the mechanical adjustment components or vibration parameters as needed; and removing and cleaning or replacing the device after use.

[0072] A specific embodiment of a customizable, adjustable, expandable, and vibration-assisted 3D-printed nasal support device:

[0073] Adult full-function version: The main support body 1 is 65mm long and 6mm in diameter, with three ring structures 2 with nickel-titanium alloy wires, embedded with electrodes, two mechanical adjustment components, a rear flutter valve to provide 12cmH2O positive pressure, a built-in 150Hz vibrator, and an external regulator to control vibration and heating; the drug compartment capacity is 0.2ml.

[0074] Simplified version for children: The support body 1 is 40mm long and has two ring structures with electrodes embedded in nickel-titanium alloy wires. The vibration unit 9 uses a low intensity of 100Hz. The positive pressure valve limits the H2O to 8cm. The drug compartment and sensing module are selected.

[0075] Version for patients with nasal turbinate hypertrophy: Enhanced mid-section support, increased mechanical adjustment components, higher vibration frequency and positive pressure (180Hz, 15cmH2O) to improve severe obstruction.

[0076] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the implementation of the present invention. For those skilled in the art, other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively describe all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the claims of the present invention.

Claims

1. A customizable, adjustable, expandable, and vibration-assisted 3D-printed nasal cavity support device, characterized in that, include: A hollow tubular support body (1) made of biocompatible material by 3D printing, with a blunt front end; A multi-segment expansion mechanism includes at least one expansion unit disposed along the periphery of the support body (1); the expansion unit is a ring structure (2) with an inherent shape memory segment anchored inside, and the expansion unit is configured to expand radially when activated; A vibration and positive pressure assist module is disposed at the tail end of the support body (1) for generating vibration and / or positive expiratory pressure.

2. The customizable, adjustable, expandable, and vibration-assisted 3D-printed nasal cavity support device according to claim 1, characterized in that, The shape memory segment is a nickel-titanium alloy wire or a shape memory polymer; and The shape memory segment is also embedded with electrodes, which are configured to heat the shape memory segment after power is applied to activate its expansion.

3. The customizable, adjustable, expandable, and vibration-assisted 3D-printed nasal cavity support device according to claim 1, characterized in that, The multi-segment expansion mechanism also includes at least one mechanical adjustment component; The mechanical adjustment assembly includes an elastic membrane (3) covering the periphery of the support body (1), and at least one connecting rod assembly disposed inside the elastic membrane (3) and driven by the internal mechanism of the support body (1). The connecting rod assembly is configured to lift the elastic membrane (3) when driven, thereby achieving radial expansion.

4. The customizable, adjustable, expandable, and vibration-assisted 3D-printed nasal cavity support device according to claim 3, characterized in that, The connecting rod assembly includes: Two rotatably connected connecting rods (4), one of which is rotatably connected to the support body (1); A slidable motion ring (5) is disposed within the support body (1), and is rotatably connected to another connecting rod through a connecting block passing through a groove (6) in the side wall of the support body (1); The supporting body (1) is provided with a driving mechanism for driving the motion ring (5) to slide.

5. The customizable, adjustable, expandable, and vibration-assisted 3D-printed nasal cavity support device according to claim 4, characterized in that, The drive mechanism includes: A screw (7) rotatably connected to the support body (1); A connecting frame (8) is fixedly connected to the moving ring (5), and the screw (7) passes through the connecting frame (8) and is threadedly engaged with it; A miniature stepper motor for driving the screw (7) to rotate.

6. The customizable, adjustable, expandable, and vibration-assisted 3D-printed nasal support device according to claim 1, characterized in that, The vibration and positive pressure auxiliary module includes: The vibration unit (9) is a miniature electromagnetic loudspeaker or piezoelectric vibrator that is fixedly embedded in the inner wall of the support body (1); The exhalation positive / oscillating one-way valve is a flutter valve or a micro turbine located at the tail end of the support body (1); A controller is used to control the operating parameters of the vibration unit (9).

7. The customizable, adjustable, expandable, and vibration-assisted 3D-printed nasal support device according to claim 1, characterized in that, Also includes: The drug sustained release and humidification component (10) includes micropores and / or drug compartments disposed on the support body (1) for sustained release of drugs and maintenance of local humidity.

8. The customizable, adjustable, expandable, and vibration-assisted 3D-printed nasal cavity support device according to claim 1, characterized in that, Also includes: Safety components include a flexible limiting wing (11) fixed to the front end of the support body (1), and / or a pull-back rope or safety ring disposed at the rear end of the support body (1).

9. The customizable, adjustable, expandable, and vibration-assisted 3D-printed nasal cavity support device according to claim 1, characterized in that, The supporting body (1) also integrates a sensor group, which includes one or more of a pressure sensor, a flow sensor, and a temperature and humidity sensor; The supporting body (1) is also provided with a wireless communication module (12) at its tail end, which is used to send sensor data to external devices.

10. A method for manufacturing a nasal support device as described in any one of claims 1-9, characterized in that, Includes the following steps: S1. Obtain anatomical data of the patient's nasal cavity through medical imaging scans; S2. Parametric modeling is performed based on anatomical structure data to generate a customized 3D model of the supporting structure; S3. Using multi-material 3D printing technology, the support body and expansion unit are integrally formed, wherein the shape memory segment is anchored in the expansion unit during the printing process; S4. Integrate the vibration and positive pressure auxiliary module and sensor group within the support body.

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