Nasal balloon catheter and preparation method

Abstract

The invention relates to a nasal cavity balloon catheter and a preparation method. The nasal cavity balloon catheter comprises an expansion body and an injection part communicated with the expansion body. The dilation body comprises a positioning and fixing structure and a dilation structure, the positioning and fixing structure can be supported in the nasal cavity of a target object, and the dilation structure can be converted from a contraction configuration to a dilation configuration when the injection part injects the filling medium; under the expansion configuration, the expansion body is matched with a physiological anatomical structure in the nasal cavity of a target object; at least one ventilation catheter is arranged in the expansion body in a penetrating mode, an inner cavity of the ventilation catheter is a ventilation channel, one end of the ventilation channel is communicated with the outside atmosphere, and the other end of the ventilation channel is communicated with an air channel in the nasal cavity. Compared with the prior art, the invention solves the problems of inaccurate reduction and large injury in the existing nasal bone fracture treatment; the compression is not thorough when the nose bleeding; postoperative nasal tamponade leads to incapability of ventilation and low comfort in treatment; a nasal cavity stenosis treatment method is poor in effect; and drainage and cleaning of the nasal cavity cannot be realized while the nasal cavity is filled.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a nasal balloon catheter and a preparation method thereof. Background Art

[0002] The nose is located at the most prominent part of the face and is easily injured by external forces. The bones are thin and wide, and due to the lack of support from the surrounding bones, it is relatively fragile and prone to fractures. Nasal bone fractures are common facial injuries, accounting for about 50% of ENT traumatic diseases. Nasal bone fractures are mostly caused by direct violence, such as intentional or unintentional trauma during exercise, fighting, traffic or industrial accidents, etc. Nasal bone fractures can also be caused by landing on the nose or forehead during a fall. Nasal bone fractures can affect the appearance of the face and the ventilation function of the nasal cavity. Nasal bone fractures can occur alone, and in severe cases, they can be combined with nasal septum fractures, cartilage dislocations, maxillary frontal processes, sinuses, orbital walls, skull base, etc., leading to structural and functional abnormalities of the corresponding parts. The traditional treatment of nasal bone fractures is to use metal nasal bone reduction forceps to reduce the fractured nasal bone to its original position. The reduction is not accurate, the patient is in pain, and the nasal mucosa is severely damaged.

[0003] Nosebleed, also known as epistaxis, refers to the rupture of blood vessels in the nasal cavity and surrounding tissues, and blood flows forward through the nostrils or backward into the oropharynx. It is one of the common clinical symptoms and can be caused by diseases of the nose itself or by systemic diseases. Nosebleeds are mostly unilateral or bilateral; they can bleed intermittently and repeatedly, or they can bleed continuously. The amount of bleeding varies. In mild cases, there is only blood in the nasal mucus, and in severe cases, it can cause hemorrhagic shock. Repeated bleeding can lead to anemia. Conventional treatment methods for nosebleeds can use toilet paper, cotton balls, ice water mixtures, expanded sponges, vaseline gauze and other materials to fill the nasal cavity to achieve the effect of hemostasis. However, with this treatment method, due to the complex anatomical structure inside the nasal cavity, the compression is not accurate and the hemostasis is not complete; in addition, the nasal cavity will be blocked, and the patient cannot breathe through the nose, and the treatment comfort is low.

[0004] After nasal surgery, how to promote early recovery of the surgical mucosa and prevent surgical adhesion and sinus closure is also a clinical problem that needs to be urgently solved. Nasal irrigation is an important measure to alleviate the above-mentioned postoperative complications. However, the nasal cavity is in a packed state in the early stage after nasal surgery, and it is impossible to flush and drain, missing the best time for flushing and drainage.

[0005] Therefore, a nasal balloon catheter that can solve the above problems and achieve precise minimally invasive reduction of nasal bone fractures, precise compression hemostasis after nasal surgery, packing the nasal cavity while ventilating smoothly, flushing and drainage, etc. is still to be developed. Summary of the invention

[0006] The purpose of the present invention is to provide a nasal balloon catheter and a preparation method, which can keep the patient's breathing unobstructed while supporting the nasal bone and improve the treatment comfort.

[0007] The purpose of the present invention can be achieved by the following technical solutions:

[0008] A nasal balloon catheter, which defines the desired expansion shape of the nasal cavity of a target subject as a preset shape, and the nasal balloon catheter comprises an expansion body and an injection part connected to the expansion body;

[0009] The expansion body comprises a positioning and fixing structure and an expansion structure; the positioning and fixing structure can be supported in the nasal cavity of the target object, and the expansion structure can be transformed from a contracted configuration to an expanded configuration when the injection part injects the filling medium; in the expanded configuration, the expansion body matches the physiological and anatomical structure inside the nasal cavity of the target object, and is used to reposition the nasal cavity of the target object to the preset shape;

[0010] At least one bent ventilation tube is provided through the expansion body, and a sealed expansion cavity is formed between the expansion body and the outer wall of the ventilation tube; the inner cavity of the ventilation tube is a ventilation channel; one end of the ventilation channel is connected to the outside atmosphere, and the other end of the ventilation channel is connected to the airway inside the nasal cavity.

[0011] Furthermore, the outer wall surface of the expansion body includes a nasal septum positioning fitting surface (inner surface) facing the nasal septum, a nasal bone supporting surface (outer surface) facing the nose wing, and a posterior nasal cavity supporting surface (back surface) facing the oral cavity.

[0012] Furthermore, the nasal septum positioning and fitting surface is the positioning and fixing structure, and the nasal bone supporting surface and the posterior nasal cavity supporting surface are the expansion structure. When expanded, the nasal septum positioning and fitting surface can be closely attached to the nasal septum.

[0013] Furthermore, the thickness of the nasal septum positioning fitting surface is greater than the nasal bone supporting surface and the posterior nasal cavity supporting surface.

[0014] Furthermore, the thickness of the nasal septum positioning fitting surface is 1-5 mm, the thickness of the nasal bone supporting surface is 0.5-2 mm, and the thickness of the posterior nasal cavity supporting surface is 0.5-2 mm.

[0015] Furthermore, at least a portion of the nasal septum positioning fitting surface is a rough surface (ie, an anti-slip surface), and the anti-slip design can increase friction and improve the fixing ability.

[0016] Furthermore, at least a portion of the nasal bone supporting surface is provided with an anti-adhesion coating.

[0017] Furthermore, the expansion body and the ventilation catheter are integrally formed.

[0018] Furthermore, the ventilation catheter is a bent structure, and the bending angle is about 90° to meet the actual angle of the ventilation catheter from entering the nasal cavity to leading to the airway.

[0019] Furthermore, one end of the ventilation tube extends from the nasal cavity surface to communicate with the external atmosphere; the other end extends from the posterior nasal cavity support surface to communicate with the airway inside the nasal cavity.

[0020] Furthermore, the injection portion is connected to an external filling medium supply end, and the filling medium supply end is connected to a driving member for driving the filling medium to flow toward the expansion body.

[0021] Furthermore, the nasal balloon catheter also includes an ear clamping assembly, which includes a support rod connected to the filling medium supply end and an ear fixing piece connected to the support rod.

[0022] Furthermore, in the expanded configuration, the pressure of the filling medium in the expansion body is 100-200 mm Hg.

[0023] Furthermore, the filling medium is selected from air or water.

[0024] Furthermore, the nasal balloon catheter also includes a sensor unit for monitoring the pressure value of the filling medium.

[0025] Furthermore, the sensing unit includes a pressure sensor arranged in the expansion cavity of the expansion body and a pressure display arranged on the injection part, and both the pressure sensor and the pressure display are connected to the controller.

[0026] Furthermore, the nasal balloon catheter also includes a sensor unit for monitoring the pressure value of the filling medium, and the sensor unit is arranged in the expansion cavity of the expansion body or on the wall surface corresponding to the expansion structure.

[0027] Furthermore, there are two expansion bodies, which correspond to the left nasal cavity and the right nasal cavity respectively and are connected to the injection part respectively.

[0028] Furthermore, a plurality of drainage and flushing holes are arranged on the expansion body, and the drainage and flushing holes are distributed on the expansion body in a manner similar to a ventilation catheter, and will not affect the sealing performance of the expansion body.

[0029] Furthermore, the diameter of the drainage and flushing holes is about 1 mm, and part of the drainage and flushing holes are connected to the ventilation catheter.

[0030] Furthermore, the nasal balloon catheter of this embodiment also includes a drainage and irrigation tube.

[0031] Furthermore, one end of the drainage and irrigation tube extends out of the expansion body, which can inject liquid medicine or saline into the nasal cavity from the outside into the drainage and irrigation tube; the other end is connected to some drainage and irrigation holes, so that the liquid medicine or saline can penetrate into the nasal cavity through each drainage and irrigation hole.

[0032] Furthermore, the drainage and irrigation holes are evenly distributed on the expansion body, and a three-dimensional network of multiple channels is formed through the connection between the drainage and irrigation holes and the drainage and irrigation tubes and / or the ventilation catheter.

[0033] When the expansion body is expanded to a certain extent after being injected with filling medium, the drainage flushing hole is compressed and closed due to the small diameter of the drainage flushing hole; when part of the filling medium in the expansion body is extracted, the expansion body contracts and the drainage flushing hole opens, which can be used for flushing and drainage.

[0034] The present invention also provides a method for preparing a nasal balloon catheter, comprising the following steps:

[0035] S1: Acquire nasal cavity image information corresponding to the nasal cavity of the target object, and form a first nasal cavity 3D model based on the nasal cavity image information;

[0036] S2: forming an expected nasal cavity 3D model of the target object according to the first nasal cavity 3D model obtained in S1 and the standard nasal cavity 3D model;

[0037] S3: Draw the expected expansion body model based on the expected nasal cavity 3D model obtained in S2, and obtain the expansion body and ventilation tube by 3D printing;

[0038] S4: Assemble the injection part to finally obtain the nasal balloon catheter.

[0039] Compared with the prior art, the present invention has the following beneficial effects:

[0040] (1) The nasal balloon catheter of the present invention is provided with an expansion body having a sac-like structure, and a ventilation tube is provided inside the expansion body, so that the expansion body can realize the resetting of the internal physiological structure of the nasal cavity while the patient can still keep the nasal cavity unobstructed, thereby solving the problem of low treatment comfort due to nasal obstruction in the existing treatment of nasal bone fractures.

[0041] (2) The nasal balloon catheter of the present invention can be designed according to the physiological and anatomical structure of the nasal cavity, and the shape and thickness of the expansion body are cleverly designed so that the expansion body in the expanded configuration can play a supporting role and can fit the internal structure of the nasal cavity as closely as possible, effectively performing compression and hemostasis for nasal bleeding; in addition, there is a catheter in the middle of the reducer, which can be used as ventilation and drainage after surgery, so that the patient can breathe freely without affecting the patient's sleep and rest.

[0042] (3) The expansion body of the present invention can change from a contracted configuration to an expanded configuration when a filling medium is input into the injection portion, so that the expanded configuration can match the physiological and anatomical structure of the patient's nasal cavity, and can reset the target subject's nasal cavity to a preset shape to treat nasal bone fractures.

[0043] (4) The present invention is loaded with a pressure sensor, which can sense the pressure inside the nose during internal nasal treatment, making it less invasive and more comfortable for the patient.

[0044] (5) The nasal balloon catheter of the present invention can be used on one or both sides of the patient's nasal cavity, and can be used for both children and adults. It can be applied to compression hemostasis, nasal adhesion / stenosis, collapsed nasal bone fracture, drainage ventilation and other scenarios.

[0045] (6) The nasal balloon of the present invention controls the opening and closing of the drainage holes on the balloon wall by adjusting the pressure to achieve the purpose of flushing and drainage. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] Figure 1 It is a schematic structural diagram of the nasal balloon catheter of the present invention.

[0047] Figure 2 It is the internal structure diagram of the nasal balloon catheter of the present invention.

[0048] Figure 3 This is a schematic diagram of the structure of the nasal balloon catheter according to Example 2 of the present invention.

[0049] Figure 4 Schematic diagram of the structure of the nasal balloon catheter according to Example 4 of the present invention.

[0050] Figure 5 This is a schematic diagram of the structure of the expansion body of Example 7 of the present invention.

[0051] Figure 6 Schematic diagram of the structure of the nasal balloon catheter according to Example 7 of the present invention.

[0052] Description of the markings in the figure:

[0053] 1- expansion body, 11- positioning and fixing structure, 12- expansion structure;

[0054] 2-Injection part;

[0055] 3-ventilation catheter, 31-ventilation channel;

[0056] 4-Filling medium supply end;

[0057] 5- driving member;

[0058] 6-ear clamping assembly, 61-support rod, 62-ear fixing piece;

[0059] 7- Pressure sensor;

[0060] 8-Pressure display;

[0061] 9 drainage and flushing holes;

[0062] 10-Drainage irrigation tube. DETAILED DESCRIPTION

[0063] The present invention is described in detail below in conjunction with the accompanying drawings and specific embodiments. This embodiment is implemented based on the technical solution of the present invention, and provides a detailed implementation method and specific operation process, but the protection scope of the present invention is not limited to the following embodiments.

[0064] In the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inside", "outside" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific position, be constructed and operated in a specific position, and therefore cannot be understood as limiting the present invention; the terms "first", "second", and "third" are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance; in addition, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be the internal communication of two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0065] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0066] Embodiment 1:

[0067] A nasal balloon catheter defines a desired expansion shape of the nasal cavity of a target subject as a preset shape. The nasal balloon catheter comprises an expansion body 1 and an injection part 2 connected to the expansion body 1.

[0068] like Figure 1-2 As shown, the expansion body 1 is a sac-like structure, which includes a positioning and fixing structure 11 and an expansion structure 12; the positioning and fixing structure 11 can be supported in the nasal cavity of the target object, and the expansion structure 12 can be transformed from a contracted configuration to an expanded configuration when the injection part 2 injects the filling medium; in the expanded configuration, the expansion body 1 matches the physiological and anatomical structure inside the nasal cavity of the target object, and is used to reset the nasal cavity of the target object to a preset shape;

[0069] At least one bent ventilation tube 3 is provided through the expansion body 1, and a sealed expansion cavity is formed between the expansion body 1 and the outer wall of the ventilation tube 3; the inner cavity of the ventilation tube 3 is a ventilation channel 31; one end of the ventilation channel 31 is connected to the outside atmosphere, and the other end of the ventilation channel 31 is connected to the airway inside the nasal cavity.

[0070] The preparation method of the nasal balloon catheter of the present embodiment is as follows:

[0071] S1: Acquire nasal cavity image information corresponding to the nasal cavity of the target object, and form a first nasal cavity 3D model based on the nasal cavity image information;

[0072] S2: forming an expected nasal cavity 3D model of the target object according to the first nasal cavity 3D model obtained in S1 and the standard nasal cavity 3D model;

[0073] S3: based on the expected nasal cavity 3D model obtained in S2, the expected expansion body model is drawn, and the expansion body 1 and the ventilation tube 3 are obtained by 3D printing;

[0074] S4: Assemble the injection part 2, and finally obtain the nasal balloon catheter. The nasal balloon catheter of this embodiment is provided with an expansion body 1 having a contraction configuration and an expansion configuration, and the expansion configuration of the expansion body 1 is set to match the internal physiological and anatomical structure of the patient's nasal cavity, and an injection part 2 is provided, and the injection part 2 inputs the filling medium into the expansion body 1 to change it from the contraction configuration to the expansion configuration. At the same time, this embodiment further provides a ventilation catheter 3 through the expansion body 1, so that the internal airway of the nasal cavity can be connected with the outside atmosphere through the ventilation channel 31 of the ventilation catheter 3, that is, the expansion body 1 with an expansion configuration can realize the resetting of the internal physiological structure of the nasal cavity, while the patient can still keep the nasal breathing unobstructed, which solves the problem of low treatment comfort due to nasal obstruction in the existing treatment of nasal bone fractures.

[0075] Embodiment 2:

[0076] A nasal balloon catheter defines the desired expansion shape of the nasal cavity of a target object as a preset shape, and the nasal balloon catheter comprises an expansion body 1 and an injection part 2 connected to the expansion body 1. The expansion body 1 is a sac-like structure, which comprises a positioning and fixing structure 11 and an expansion structure 12; the positioning and fixing structure 11 can be supported in the nasal cavity of the target object, and the expansion structure 12 can be transformed from a contraction configuration to an expansion configuration when the injection part 2 injects a filling medium; in the expansion configuration, the expansion body 1 matches the physiological and anatomical structure inside the nasal cavity of the target object, and is used to reset the nasal cavity of the target object to the preset shape.

[0077] The difference from Example 1 is that Figure 3As shown, the outer wall surface of the expansion body 1 of this embodiment includes a nasal septum positioning fitting surface a facing the nasal septum, a nasal bone supporting surface b facing the nose wing, and a posterior nasal cavity supporting surface c facing the oral cavity. Among them, the nasal septum positioning fitting surface a is a positioning and fixing structure 11 used for support and positioning, and the nasal bone supporting surface b and the posterior nasal cavity supporting surface c are expansion structures 12. The thickness of the nasal septum positioning fitting surface a is greater than that of the nasal bone supporting surface b and the posterior nasal cavity supporting surface c. The thickness of the nasal septum positioning fitting surface a is 1-5mm, the thickness of the nasal bone supporting surface b is 0.5-2mm, and the thickness of the posterior nasal cavity supporting surface c is 0.5-2mm.

[0078] In addition, in this embodiment, at least part of the nasal septum positioning fitting surface a is a rough surface, which can increase friction and improve fixation ability; at least part of the nasal bone support surface b is provided with an anti-adhesion coating to increase expansion ability and avoid movement of tissue in the nasal cavity during expansion.

[0079] Embodiment 3:

[0080] A nasal balloon catheter defines the desired expansion shape of the nasal cavity of a target object as a preset shape, and the nasal balloon catheter comprises an expansion body 1 and an injection part 2 connected to the expansion body 1. The expansion body 1 is a sac-like structure, which comprises a positioning and fixing structure 11 and an expansion structure 12; the positioning and fixing structure 11 can be supported in the nasal cavity of the target object, and the expansion structure 12 can be transformed from a contraction configuration to an expansion configuration when the injection part 2 injects a filling medium; in the expansion configuration, the expansion body 1 matches the physiological and anatomical structure inside the nasal cavity of the target object, and is used to reset the nasal cavity of the target object to the preset shape.

[0081] The difference from Example 1 is that at least one ventilation tube 3 is provided through the expansion body 1 of this embodiment, and the expansion body 1 and the ventilation tube 3 are integrally formed. Specifically, the outer wall surface of the tube section of the ventilation tube 3 in the sac-like structure of the expansion body 1 can be used as a part of the sac-like structure, and a sealed expansion cavity is formed between the expansion body 1 and the outer wall of the ventilation tube 3, and the ventilation tube 3 and the expansion body 1 can be made of the same material. In addition, the inner cavity of the ventilation tube 3 of this embodiment is a ventilation channel 31, one end of which is connected to the outside atmosphere, and the other end of the ventilation channel 31 is connected to the airway inside the nasal cavity.

[0082] like Figure 2 As shown, the ventilation catheter 3 of this embodiment is specifically a bending structure with a bending angle of about 90° to meet the actual angle of the ventilation catheter 3 from entering the nasal cavity to leading to the airway, making the patient's breathing smoother and further improving the patient's treatment comfort.

[0083] Embodiment 4:

[0084] A nasal balloon catheter, which differs from the embodiment 1 in that the injection part 2 of the embodiment is connected to the external filling medium supply end 4, and the filling medium supply end 4 is connected to a driving member 5 for driving the filling medium to flow toward the expansion body 1. Specifically, the injection part is an injection catheter, the filling medium supply end 4 is an injection pot filled with filling medium, and the driving member 5 can be a commonly used pressure pump.

[0085] The nasal balloon catheter of this embodiment further includes an ear clamping assembly 6, which includes a support rod 61 connected to the filling medium supply end 4 and an ear fixing member 62 connected to the support rod 61. The ear fixing member 62 is adapted to the outer contour of the ear and can be hung on the ear, so that the entire nasal balloon catheter can be stably supported on the face.

[0086] Embodiment 5:

[0087] A nasal balloon catheter is different from Example 4 in that the number of expansion bodies 1 in this embodiment is two, and the two expansion bodies 1 correspond to the left nasal cavity and the right nasal cavity respectively, and the expansion bodies 1 are respectively connected to the injection part 2, so as to be suitable for patients with bilateral nasal fractures, nasal bleeding, nasal packing, etc. The bilateral expansion bodies 1 can independently repair the fractures of the nasal bones on the corresponding sides.

[0088] Embodiment 6:

[0089] A nasal balloon catheter, which differs from the embodiment 1 in that, in the expanded configuration, the pressure of the filling medium in the expansion body 1 is 100-200 mm Hg, which can be adjusted accordingly according to the patient's condition. The filling medium is selected from air or water.

[0090] In order to monitor the pressure value of the filling medium, the nasal balloon catheter also includes a sensing unit for monitoring the pressure value of the filling medium. The sensing unit includes a pressure sensor 7 arranged in the expansion cavity of the expansion body 1 and a pressure display 8 arranged on the injection part 2, and the pressure sensor 7 and the pressure display 8 are both connected to the controller. The pressure sensor 7 is distributed on the nasal septum positioning fitting surface a and / or the nasal bone support surface b. After the pressure sensor 7 senses the pressure change in the expansion body, it converts the pressure signal into an electrical signal, and converts the signal into a signal form that can be processed by the microprocessor through the signal conditioning circuit, analog-to-digital converter, etc. integrated in the pressure display 8. The microprocessor processes and calculates the signal and controls the pressure display 8 (a common LED display screen can be selected) through the driving circuit to display it. The connection relationship between this type of pressure sensor 7 and the pressure display 8 is a conventional connection and coordination, which will not be repeated here.

[0091] The sensing unit 7 can use a conventional pressure sensor, and transmit the detected pressure signal to an external device through a wireless communication module, thereby detecting the pressure of the filling medium and outputting the detection data. The doctor can control the amount of the filling medium entering the expansion body 1 according to the value of the detection data during actual operation.

[0092] Embodiment 7:

[0093] A nasal balloon catheter, which is different from the first embodiment in that the nasal balloon catheter of the present embodiment also has a drainage and flushing function for patients whose nasal cavity is in a packed state after nasal surgery. At this time, the patient is already in the treatment of the nasal balloon catheter, such as nasal bone fracture reduction, nasal compression hemostasis, etc.

[0094] Specifically, Figure 5-6 As shown, a plurality of drainage irrigation holes 9 are arranged on the nasal septum positioning fitting surface a, the nasal bone support surface b and the posterior nasal cavity support surface c of the expansion body 1 of this embodiment. The drainage irrigation holes 9 are distributed on the expansion body 1 in a manner similar to the ventilation catheter 3, and will not affect the sealing of the expansion body 1. The aperture of the drainage irrigation hole 9 is about 1 mm, and part of the drainage irrigation holes 9 are connected to the ventilation catheter 3. The nasal balloon catheter of this embodiment also includes a drainage irrigation tube 10. One end of the drainage irrigation tube 10 extends out of the expansion body 1, and liquid medicine or saline can be injected into the nasal cavity from the outside into the drainage irrigation tube 10; the other end of the drainage irrigation tube 10 is connected to part of the drainage irrigation holes 9, so that the liquid medicine or saline is infiltrated into the nasal cavity through each drainage irrigation hole 9. Therefore, the drainage irrigation holes 9 of this embodiment are evenly distributed on the expansion body 1, and a multi-channel three-dimensional network form is formed by the connection between the drainage irrigation holes 9 and the drainage irrigation tube 10 and / or the ventilation catheter 3.

[0095] When the expansion body 1 is expanded to a certain extent after being injected with filling medium, the drainage flushing hole 9 will be compressed and closed due to the small aperture of the drainage flushing hole 9; when part of the filling medium in the expansion body 1 is extracted, the expansion body 1 contracts and the drainage flushing hole 9 opens, which can be used for flushing and drainage.

[0096] If the patient feels itchy, dry or has a lot of secretions in the nasal cavity 24 hours or 48 hours after the operation, the medical staff will extract part of the liquid in the expansion body 1 through the injection part 2 to reduce the airbag pressure and open the drainage and flushing holes 9. The secretions on the inner wall of the nasal cavity can be drained to the ventilation catheter 3 or the drainage and flushing tube 10 through the drainage and flushing holes 9 distributed on each surface of the expansion body 1. Liquid medicine or saline can also be injected into each drainage and flushing hole 9 through the drainage and flushing tube 10 to flush the inner side of the nasal cavity or perform drug treatment, and the residual liquid medicine can be discharged from the body through the ventilation catheter 3.

[0097] Embodiment 8:

[0098] A nasal balloon catheter is suitable for compression hemostasis after nasal surgery, dilation treatment of nasal stenosis caused by various reasons, reduction of nasal bone fractures, ventilation and drainage after nasal surgery, nasal packing and shaping, etc., and defines the desired dilation shape of the patient's nasal cavity as a preset shape. The nasal balloon catheter of this embodiment includes at least one dilation body 1 and an injection part 2.

[0099] The expansion body 1 is configured to be arranged in the patient's nasal cavity, and is configured to change between a contracted configuration and an expanded configuration. In the expanded configuration, the expansion body 1 matches the physiological and anatomical structure inside the patient's nasal cavity to support and reset the patient's nasal cavity to a preset shape. The injection part 2 is configured to be connected to the expansion body 1, and is configured to inject a filling medium into the expansion body 1 to change the expansion body 1 from a contracted configuration to an expanded configuration. Each expansion body 1 is provided with at least one ventilation channel 31, and the head end of the ventilation channel 31 is connected to the outside atmosphere, and the tail end of the ventilation channel 31 is connected to the patient's internal nasal airway.

[0100] The specific structure of the nasal balloon catheter of this embodiment is further described below:

[0101] In this embodiment, in the case of treating unilateral nasal bone fracture, nasal stenosis, etc., the number of the above-mentioned expander 1 can be one (i.e., only a single nasal cavity needs to be supported). In the case of treating bilateral nasal bone fracture, nasal stenosis, etc., the number of the above-mentioned expander 1 can be two, corresponding to the left and right nasal cavities of the patient, respectively, to support both nasal cavities.

[0102] In this embodiment, in order to ensure the positioning and fixation in the nasal cavity, the above-mentioned expansion body 1 can be configured to have a positioning and fixing structure 11 and an expansion structure 12. The positioning and fixing structure 11 is configured to be positioned and fixed in the patient's nasal cavity and serve as a support for the expansion structure 12, and the expansion structure 12 is configured to expand under the action of the filling medium, that is, the positioning and fixing structure 11 achieves the relative position fixation of the expansion body 1 and the nasal cavity by cooperating with the nasal cavity inner wall structure, and the expansion structure 12 expands under the action of the filling medium to support the nasal bone or other nasal cavity structures, so that the patient's nasal cavity reaches the above-mentioned preset shape.

[0103] Furthermore, the outer wall surface of the expansion body 1 can be specifically configured to include a nasal septum positioning fitting surface facing the nasal septum, a nasal bone supporting surface facing the nose wing, and a posterior nasal cavity supporting surface facing the oral cavity. The nasal septum positioning fitting surface can be set as the above-mentioned positioning and fixing structure 11, and the nasal bone supporting surface and / or the posterior nasal cavity supporting surface can be set as the above-mentioned expansion structure 12. Among them, the thickness of the nasal septum positioning fitting surface is greater than the nasal bone supporting surface and the posterior nasal cavity supporting surface, and the thickness can be increased to make the wall surface of the expansion body 1 corresponding to the nasal septum positioning fitting surface have stronger mechanical properties, thereby playing a fixing role and serving as a mechanical support surface, while the nasal bone supporting surface and the posterior nasal cavity supporting surface can be set to be thinner, thereby having a certain elasticity, and can expand under the action of the filling medium, and serve as a force-generating surface to support the nasal cavity part that needs to be supported.

[0104] Specifically, the material of the expansion body 1 can be medical silicone or medical plastic (specifically, the elastic modulus can be between 5MPa and 30MPa). The thickness of the nasal septum positioning fitting surface can be set to 1mm to 5mm (the deformation index (maximum strain range) of the wall corresponding to the nasal septum positioning fitting surface can be in the range of 10% to 40%, which is not specifically limited here); the thickness of the nasal bone support surface can be set to 0.5mm to 2mm (the deformation index (maximum strain range) of the wall corresponding to the nasal bone support surface 14 can be in the range of 10% to 50%, which is not specifically limited here); the thickness of the posterior nasal cavity support surface can be set to 0.5mm to 2mm (similarly, the deformation index (maximum strain range) of the wall corresponding to the posterior nasal cavity support surface is in the range of 10% to 50%, which is not specifically limited here).

[0105] In this embodiment, at least part of the nasal septum positioning fitting surface can be configured as a rough surface (anti-slip design). The thickened and anti-slip design can increase friction and enhance the fixation ability. At least part of the nasal bone support surface can be provided with an anti-adhesion coating. The thinning and anti-adhesion coating design can increase the expansion ability and avoid the movement of tissue in the nasal cavity during the expansion process.

[0106] In the present embodiment, the nasal balloon catheter also includes a ventilation catheter 3, which runs through the expansion body 1, and the ventilation cavity of the ventilation catheter 3 is the ventilation channel 31 mentioned above. That is, the expansion body 1 can be specifically configured as a sac-like structure surrounding the ventilation catheter 3, and the sac-like structure and the ventilation catheter 3 are fixedly connected. In the present embodiment, the entire balloon surface is also wrapped with a layer of water-absorbing resin, which can achieve anti-slip and water-absorbing effects. The water-absorbing resin can absorb a large amount of water and is a new type of functional polymer material. It also has extremely strong moisture retention. The water-absorbing resin is non-toxic and non-irritating. It will not react after contacting with human skin, and will not have a significant impact on the environment. Therefore, it is widely used in medical, industrial, and health fields.

[0107] Furthermore, in order to improve the user experience of the patient, one end of the ventilation tube 3 extending into the patient's nasal cavity is provided with an avoidance angle, that is, to prevent the extending end of the ventilation tube 3 from hitting the tissue in the patient's nasal cavity. Specifically, for the nasal cavity of children, the length of the ventilation tube 3 extending from the saccular structure can be 2mm to 5mm, and the diameter of the ventilation tube 3 can be 3mm to 5mm; for the nasal cavity of adolescent patients, the length of the ventilation tube 3 extending from the saccular structure can be 3mm to 6mm, and the diameter of the ventilation tube 3 can be 4mm to 6mm; for the nasal cavity of adult patients, the length of the ventilation tube 3 extending from the saccular structure can be 4mm to 7mm, and the diameter of the ventilation tube 3 can be 4mm to 7.5mm.

[0108] In this embodiment, the ventilation catheter 3 and the expansion body 1 are integrally formed. The outer wall surface of the tube section of the ventilation catheter 3 in the sac-like structure can be used as a part of the sac-like structure, and the ventilation catheter 3 and the expansion body 1 can be made of the same material.

[0109] In the present embodiment, for the scenario where the number of expansion bodies 1 is one, the above-mentioned injection part 2 can specifically be an injection tube, the diameter of the injection tube can be set to be smaller than the inner diameter of the ventilation tube 3, and the injection tube can be set to be arranged in a close fit on the inner wall surface of the ventilation tube 3, and one end of the injection tube passes through the ventilation tube 3 and is connected to the inner cavity of the expansion body 1 (of course, in other embodiments, the injection tube can also be set to be connected to the inner cavity of the expansion body 1 through a connection interface on the expansion body 1 or directly fixedly connected to the expansion body 1), and the other end can be set to extend out of the ventilation tube 3 and be connected to the external filling medium supply end 4 (for example, an injection pot filled with filling medium can be used).

[0110] In this embodiment, in the case where there are two expansion bodies 1, the two expansion bodies 1 correspond to the left nasal cavity and the right nasal cavity respectively, and the expansion bodies 1 are respectively connected to the injection part 2, so as to be suitable for patients with bilateral nasal fractures, and the expansion bodies 1 on both sides can independently repair the nasal bones on the corresponding sides. In addition, the two injection parts 2 can be independently connected to the filling medium supply end 4, and the two balloon catheters can also be respectively fixed on the patient's ears through the ear clamping assembly 6.

[0111] In this embodiment, in order to ensure that the supporting force inside the nasal cavity meets the treatment requirements, in the expanded configuration, the filling medium pressure in the above-mentioned expansion body 1 (cystic structure) can be 100 mmHg-200 mmHg. The filling medium pressure for adult patients can be relatively wide, depending on the applicable disease; and the filling medium pressure for pediatric patients can be set to a relatively low value, such as 100 mmHg-150 mmHg, to avoid unnecessary stimulation or damage to the nasal cavity of children, and the specific adjustment also needs to be made according to factors such as the child's age, weight and condition.

[0112] In this embodiment, the nasal balloon catheter may also include a sensing unit to detect the pressure of the filling medium in the expansion body 1. The sensing unit of this embodiment includes a pressure sensor 7, which is arranged in the inner cavity of the expansion body 1 or on the surface corresponding to the above-mentioned expansion structure 12, and is used to detect the pressure of the filling medium and output a pressure signal. The sensing unit also includes a pressure display 8, which is used to display the pressure signal sensed by the pressure sensor 7 in real time on the display screen, so that the doctor can control the amount of filling medium entering the expansion body 1 according to the numerical value of the detection data during actual operation. Further, the above-mentioned pressure sensor 7 can also be set on the injection part (the above-mentioned injection tube), and both can realize the detection of the filling medium pressure. In this embodiment, the above-mentioned filling medium can be a fluid, specifically air or water. In this embodiment, the nasal balloon catheter may also include an injection plug, which can be configured to block the filling medium inlet on the expansion body 1 or block the input end of the above-mentioned injection part 2.

[0113] The nasal balloon catheter of this embodiment can be specifically applied to compression hemostasis (the purpose of hemostasis is achieved by expanding and compressing the nasal mucosa through the expansion body 1), nasal adhesion / stenosis (the narrow nasal cavity is enlarged by expanding the space through the expansion body 1), collapsed nasal bone fracture (the collapsed nasal bone is repositioned by expanding through the expansion body 1), drainage and ventilation (it changes the traditional treatment method of iodoform oil sand strips, which causes nasal obstruction and discomfort for patients; the shape of the packing is clumpy and inconsistent with the normal physiological nasal cavity. While "compressing hemostasis", "dilatating the nasal cavity" and "repositioning the nasal bone", it can also play the function of drainage and ventilation) and other scenarios.

[0114] Embodiment 9:

[0115] This embodiment provides a method for preparing a nasal balloon catheter, which is applied to the nasal balloon catheter in the above-mentioned embodiment 8, and specifically comprises the following steps:

[0116] The nasal imaging information corresponding to the volunteer's nasal cavity was obtained, and the first nasal 3D model was formed based on the nasal imaging information. The noses of volunteers of different ages were selected. Those with no history of chronic upper respiratory tract diseases, no history of nasal trauma and surgery, and no history of acute upper respiratory tract diseases in the past 3 months were selected. Those who had no signs of nasal diseases or obvious anatomical abnormalities after anterior rhinoscopy and nasal endoscopy were selected (Note: those with no nasal diseases and functional disorders but obvious nasal septum deviation were excluded). After the volunteers were quiet for 30 minutes at room temperature (about 20°C), the coronal continuous scan of the nose was performed, ranging from the tip of the nose to the posterior wall of the nasopharynx, with a layer thickness of 3mm, a layer spacing of 3mm, and a soft tissue window was selected as the window position. The obtained DICOM imaging data was converted into BMP format images using the software provided by the Siemens multi-slice spiral CT machine. The image in BMP format obtained above was digitized by using the image reading function of Matlab software, and the boundary of the nasal airway was identified by using a self-compiled program, and then imported into Ansys 6.1 software. The surface of the nasal airflow channel and the maxillary sinus cavity was reconstructed in three dimensions with the help of the pre-processing function of the software. The pre-processing function of the finite element analysis software Ansys 6.1 was used to select the key points of each layer that can accurately reflect the basic structural characteristics of the nasal airflow channel and the maxillary sinus cavity, connect them into lines, and further construct faces and bodies in sequence. The tetrahedron unit was used to perform finite element segmentation on the entire nasal airflow channel and the maxillary sinus cavity, and the digital reconstruction of the airflow channel and the maxillary sinus cavity was completed. Finally, the expected expansion body model was drawn based on the expected nasal 3D model, and the expansion body 1 and ventilation catheter 3 of the nasal balloon catheter were obtained by 3D printing. When printing the expansion body 1, a filling medium inlet for assembling the injection part 2 was reserved, and finally the injection part 2 was assembled to obtain the nasal balloon catheter.

[0117] Embodiment 10:

[0118] This embodiment describes the practical application of the nasal balloon catheter in the above-mentioned embodiment 8.

[0119] 1. Unilateral nasal bone fracture: Under local / general anesthesia, adults can use cotton pads soaked in 1% tetracaine to perform surface anesthesia of the nasal mucosa, and children can use general anesthesia. Then, a nasal balloon catheter is placed in the nasal cavity on the side of the fractured nasal bone, and the pressure is pressed to 150 mm Hg (the specific pressure depends on the patient's condition). The expansion time is 2 minutes, the balloon is depressurized, and the low pressure state is maintained. Use the index finger and thumb of the other hand to assist outside the nose to perform nasal bone reduction. The reduction is successful under nasal endoscopy, the nasal bone is observed from the outside of the nose, and bone friction sound is heard. Nasal packing can be performed after the operation.

[0120] 2. Bilateral nasal bone fracture: Adults can use 1% tetracaine soaked cotton pads to perform surface anesthesia of the nasal mucosa, and children can be general anesthetized. Then two nasal balloon catheters are placed in the nasal cavity of the fractured nasal bone, and the pressure is pressed to 150mm Hg (the specific pressure depends on the patient's condition). The expansion time is 2 minutes, and the balloon is depressurized and maintained at a low pressure state. Use the index finger and thumb of the other hand to assist in the nasal bone reduction. The reduction is successful under nasal endoscopy. The nasal bone is observed from the outside of the nose, and bone friction sound is heard. Nasal packing can be performed after the operation.

[0121] The above description of the embodiments is to facilitate the understanding and use of the invention by those skilled in the art. It is obvious that those skilled in the art can easily make various modifications to these embodiments and apply the general principles described herein to other embodiments without creative work. Therefore, the present invention is not limited to the above embodiments, and improvements and modifications made by those skilled in the art based on the disclosure of the present invention without departing from the scope of the present invention should be within the scope of protection of the present invention.

Claims

1. A nasal balloon catheter, characterized in that: The desired expansion shape of the nasal cavity of the target subject is defined as a preset shape, and the nasal balloon catheter comprises an expansion body (1) and an injection part (2) connected to the expansion body (1); The expansion body (1) comprises a positioning and fixing structure (11) and an expansion structure (12); the positioning and fixing structure (11) can be supported in the nasal cavity of the target object, and the expansion structure (12) can be transformed from a contracted configuration to an expanded configuration when the injection part (2) injects the filling medium; in the expanded configuration, the expansion body (1) matches the physiological and anatomical structure inside the nasal cavity of the target object, and is used to reposition the nasal cavity of the target object to the preset shape; At least one ventilation tube (3) is provided through the expansion body (1), and a sealed expansion cavity is formed between the expansion body (1) and the outer wall of the ventilation tube (3); the inner cavity of the ventilation tube (3) is a ventilation channel (31); one end of the ventilation channel (31) is connected to the outside atmosphere, and the other end of the ventilation channel (31) is connected to the airway inside the nasal cavity.

2. A nasal balloon catheter according to claim 1, characterized in that: The outer wall surface of the expansion body (1) comprises a nasal septum positioning and fitting surface facing the nasal septum, a nasal bone supporting surface facing the nose wing, and a posterior nasal cavity supporting surface facing the oral cavity; Among them, the nasal septum positioning and fitting surface is the positioning and fixing structure (11), and the nasal bone supporting surface and the posterior nasal cavity supporting surface are the expansion structure (12).

3. A nasal balloon catheter according to claim 2, characterized in that: The thickness of the nasal septum positioning fitting surface is greater than the nasal bone supporting surface and the posterior nasal cavity supporting surface; The thickness of the nasal septum positioning fitting surface is 1-5 mm, the thickness of the nasal bone supporting surface is 0.5-2 mm, and the thickness of the posterior nasal cavity supporting surface is 0.5-2 mm.

4. A nasal balloon catheter according to claim 2, characterized in that: At least a portion of the nasal septum positioning and fitting surface is a rough surface, and at least a portion of the nasal bone supporting surface is provided with an anti-adhesion coating.

5. A nasal balloon catheter according to claim 1, characterized in that: The injection portion (2) is connected to an external filling medium supply end (4), and the filling medium supply end (4) is connected to a driving member (5) for driving the filling medium to flow toward the expansion body (1).

6. A nasal balloon catheter according to claim 1, characterized in that: The nasal balloon catheter further comprises an ear clamping assembly (6), wherein the ear clamping assembly (6) comprises a support rod (61) connected to the filling medium supply end (4) and an ear fixing member (62) connected to the support rod (61).

7. A nasal balloon catheter according to claim 1, characterized in that: In the expanded configuration, the pressure of the filling medium in the expansion body (1) is 100-200 mm Hg; The filling medium is selected from air or water.

8. A nasal balloon catheter according to claim 1, characterized in that: The nasal balloon catheter also includes a sensor unit for monitoring the pressure value of the filling medium; The sensing unit comprises a pressure sensor (7) arranged in the expansion cavity of the expansion body (1) and a pressure display (8) arranged on the injection part (2); the pressure sensor (7) and the pressure display (8) are both connected to the controller.

9. A nasal balloon catheter according to claim 1, characterized in that: The number of the expansion bodies (1) is two, and the two expansion bodies (1) correspond to the left nasal cavity and the right nasal cavity respectively and are connected to the injection part (2) respectively.

10. A method for preparing the nasal balloon catheter according to any one of claims 1 to 9, characterized in that: The following steps are involved: S1: Acquire nasal cavity image information corresponding to the nasal cavity of the target object, and form a first nasal cavity 3D model based on the nasal cavity image information; S2: forming an expected nasal cavity 3D model of the target object according to the first nasal cavity 3D model obtained in S1 and the standard nasal cavity 3D model; S3: Drawing the expected expansion body model based on the expected nasal cavity 3D model obtained in S2, and obtaining the expansion body (1) and the ventilation tube (3) by 3D printing; S4: Assemble the injection part (2) to finally obtain the nasal balloon catheter.

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