Nasal balloon catheter and method of making

Abstract

The present application relates to a kind of nasal balloon catheter and preparation method, the nasal balloon catheter includes expansion body and with expansion body communication injection part;The expansion body includes positioning fixed structure and expansion structure, positioning fixed structure can be supported in the nasal cavity of target object, expansion structure can be converted from shrink configuration to expansion configuration when injection filling medium in injection part;In expansion configuration, the expansion body matches with the internal physiological structure of the nasal cavity of target object;At least one ventilation catheter is provided in the expansion body, the inner cavity of ventilation catheter is ventilation passage, one end of ventilation passage is communicated with external atmosphere, the other end is communicated with nasal cavity internal airway.Compared with prior art, the present application solves the problems of inaccurate reduction, large damage in existing nasal bone fracture treatment, incomplete compression of nasal bleeding, low comfort level caused by nasal postoperative tamponade, poor effect of nasal cavity narrow treatment method, nasal cavity tamponade while unable to drain and clean nasal cavity and the like.

Description

TECHNICAL FIELD

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

[0002] The nose is located at the most protruding part of the face and is easily injured by external force. The bone is thin and wide, and is relatively fragile due to the lack of support from surrounding bone, and is prone to fracture. Nasal bone fracture is a common facial injury, accounting for about 50% of otolaryngology trauma diseases. Nasal bone fracture is usually caused by direct violence, such as intentional or unintentional trauma during exercise, fighting, traffic or work accidents, etc. Nose or forehead landing when falling can also cause nasal bone fracture. Nasal bone fracture can affect the appearance of the face and the ventilation function of the nasal cavity. Nasal bone fracture can occur alone, and severe cases can be combined with nasal septum fracture, cartilage dislocation, maxillary frontal process, nasal sinus, orbital wall, skull base and other injuries, leading to abnormalities in the structure and function of the corresponding parts. The traditional treatment for nasal bone fracture 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 damage to the nasal mucosa is large.

[0003] Nosebleed, also known as epistaxis, is a common clinical symptom, which is caused by the rupture of blood vessels in the nasal cavity and surrounding tissues, and the flow of blood out of the nostrils or into the pharynx. It is usually unilateral, but can also be bilateral. It can be intermittent and repeated, or continuous. The amount of bleeding varies from a little blood in the nasal discharge to severe cases that can cause hemorrhagic shock. Repeated bleeding can lead to anemia. The conventional treatment method for nosebleed is to use toilet paper, cotton balls, ice water mixture, expanded sponge, Vaseline gauze and other materials to pack the nasal cavity to achieve hemostasis. However, due to the complex anatomical structure of the nasal cavity, the compression is not accurate and the hemostasis is not complete. In addition, the nasal cavity is blocked and the patient cannot breathe through the nasal cavity, resulting in low treatment comfort.

[0004] After nasal surgery, how to promote the early recovery of the mucosa in the surgical cavity and prevent adhesion and closure of the surgical cavity is also a problem that needs to be solved in clinical practice. Nasal irrigation is an important measure to reduce the above-mentioned postoperative complications. However, the nasal cavity is in a packed state in the early postoperative period, and cannot be irrigated and drained, missing the best time for irrigation and drainage.

[0005] Therefore, there is still a need to develop a nasal balloon catheter that can solve the above problems, achieve accurate and minimally invasive reduction of nasal bone fracture, accurate compression hemostasis after nasal surgery, smooth ventilation while packing the nasal cavity, and irrigation and drainage. SUMMARY

[0006] The purpose of the present application is to provide a nasal balloon catheter and a preparation method that can maintain smooth breathing of the patient during nasal bone support and improve treatment comfort.

[0007] The object of the present application can be achieved by the following technical solutions:

[0008] A nasal balloon catheter defines a preset shape of a nasal cavity of a target object required for expansion, and the nasal balloon catheter comprises an expansion body and an injection part in communication with 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 a filling medium; in the expanded configuration, the expansion body matches the internal physiological structure of the nasal cavity of the target object, and is used for resetting the nasal cavity of the target object to the preset shape.

[0010] At least one bent ventilation conduit is provided in the expansion body, and a sealed expansion cavity is formed between the expansion body and the outer wall of the ventilation conduit; the inner cavity of the ventilation conduit is a ventilation passage; one end of the ventilation passage is in communication with the outside atmosphere, and the other end of the ventilation passage is in communication with the internal airway of the nasal cavity.

[0011] Further, the outer wall surface of the expansion body comprises a nasal septum positioning and fitting surface (inner surface) facing the nasal septum, a nasal bone supporting surface (outer surface) facing the alae nasi, and a posterior nasal cavity supporting surface (rear surface) facing the oral cavity.

[0012] Further, 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. The nasal septum positioning and fitting surface can be tightly attached to the nasal septum during expansion.

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

[0014] Further, the thickness of the nasal septum positioning and 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] Further, at least part of the nasal septum positioning and fitting surface is a rough surface (i.e. an anti-slip surface), which can increase the friction and improve the fixing capacity through the anti-slip design.

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

[0017] Further, the expansion body and the ventilation conduit are integrally formed.

[0018] Further, the ventilation conduit is a bent structure, and the bending angle is about 90° to conform to the actual angle of the ventilation conduit from entering the nasal cavity to the airway.

[0019] Further, one end of the ventilation conduit extends from the nasal cavity surface and is used for communication with the external atmosphere; the other end extends from the rear nasal cavity support surface and is in communication with the internal nasal cavity airway.

[0020] Further, the injection part is connected with an external filling medium supply end, and the filling medium supply end is connected with a driving member for driving the filling medium to flow into the expansion body.

[0021] Further, the nasal cavity balloon catheter further comprises an ear clamping assembly, which comprises a support rod connected with the filling medium supply end and an ear fixing member connected with the support rod.

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

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

[0024] Further, the nasal cavity balloon catheter further comprises a sensing unit for monitoring the pressure value of the filling medium.

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

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

[0027] Further, the number of the expansion bodies is two, and the two expansion bodies correspond to the left nasal cavity and the right nasal cavity respectively and are connected with the injection part respectively.

[0028] Further, 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 the ventilation conduit and do not affect the sealing property of the expansion body.

[0029] Further, the drainage and flushing holes have a diameter of about 1 mm, and part of the drainage and flushing holes are in communication with the ventilation conduit.

[0030] Further, the nasal cavity balloon catheter of the embodiment further comprises a drainage and flushing tube.

[0031] Further, one end of the drainage and flushing tube extends out of the expansion body and can inject liquid medicine or normal saline into the nasal cavity from the outside; the other end is in communication with part of the drainage and flushing holes, so that the liquid medicine or normal saline can be infiltrated into the nasal cavity through the drainage and flushing holes.

[0032] Further, the drainage and flushing holes are uniformly distributed on the expansion body, and the communication of the drainage and flushing holes with the drainage and flushing tube and / or the ventilation catheter forms a multi-channel three-dimensional network form.

[0033] When the expansion body is expanded to a certain extent by injecting the filling medium, the drainage and flushing holes are closed due to the small pore size of the drainage and flushing holes; when part of the filling medium in the expansion body is extracted, the expansion body is contracted, and the drainage and flushing holes are opened for drainage and flushing.

[0034] The application also provides a preparation method of the nasal balloon catheter, comprising the following steps:

[0035] S1: obtaining nasal cavity image information corresponding to the nasal cavity of the target object, and forming 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 a standard nasal cavity 3D model;

[0037] S3: drawing an expected expansion body model based on the expected nasal cavity 3D model obtained in S2, and obtaining the expansion body and the ventilation catheter through 3D printing;

[0038] S4: assembling an injection part, and finally obtaining the nasal balloon catheter.

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

[0040] (1) The nasal balloon catheter of the application is provided with an expansion body having a balloon structure, and a ventilation catheter is arranged in the expansion body, so that the expansion body can reset the physiological structure of the nasal cavity while the patient can still maintain the patency of the nasal cavity for breathing, thereby solving the problem of low treatment comfort caused by nasal cavity obstruction in the treatment of nasal bone fracture.

[0041] (2) The nasal balloon catheter of the application can be designed according to the internal anatomical structure of the nasal cavity, and the shape and thickness of the expansion body are designed ingeniously, so that the expansion body in the expansion configuration can play a supporting role and can also be as close as possible to the internal structure of the nasal cavity to effectively perform nasal cavity bleeding compression hemostasis, etc.; in addition, the catheter in the reset device can be used as postoperative ventilation and drainage, and the patient can breathe freely without affecting the patient's sleep and rest.

[0042] (3) The expansion body of the application can change from a contracted configuration to an expanded configuration when the filling medium is input into the injection part, so that the expanded configuration can match the internal anatomical structure of the nasal cavity of the patient, and the nasal cavity of the target object can be reset to a preset shape to treat nasal bone fracture.

[0043] (4) The present application is loaded with a pressure sensor, which can sense the pressure inside the nose during the treatment of the inside of the nose, is more minimally invasive, and is more comfortable for the patient.

[0044] (5) The nasal balloon catheter of the present application can be used for unilateral or bilateral nasal cavities of patients, and can be used for children and adults, and can be applied to compression hemostasis, nasal adhesion / narrowing, collapsed nasal bone fracture, drainage ventilation, etc.

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

[0046] Figure 1 It is a structure diagram of the nasal balloon catheter of the present application.

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

[0048] Figure 3 It is a structure diagram of the nasal balloon catheter of the present application embodiment 2.

[0049] Figure 4 It is a structure diagram of the nasal balloon catheter of the present application embodiment 4.

[0050] Figure 5 It is a structure diagram of the dilatation body of the present application embodiment 7.

[0051] Figure 6 It is a structure diagram of the nasal balloon catheter of the present application embodiment 7.

[0052] Marking explanation in the figure:

[0053] 1-dilatation body, 11-positioning and fixing structure, 12-dilatation 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-supporting rod, 62-ear fixing member;

[0059] 7-pressure sensor;

[0060] 8-pressure display;

[0061] 9-drainage flushing hole;

[0062] 10-drainage flushing tube. DETAILED DESCRIPTION

[0063] The present application will be described in detail below with reference to the drawings and specific embodiments. The embodiments are implemented on the premise of the technical solutions of the present application, and detailed implementation modes and specific operation processes are given, but the protection scope of the present application is not limited to the following embodiments.

[0064] In the present application, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application; the terms "first", "second", "third" are only for the purpose of description, and cannot be understood as indicating or implying relative importance; in addition, unless otherwise explicitly specified and limited, the terms "mounting", "connecting", "connecting" should be understood in a broad sense, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium, or it can be the communication between two elements inside. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0065] It should be noted that: similar reference numerals and letters represent similar items in the following drawings, so once an item is defined in one drawing, it does not need to be further defined and explained in subsequent drawings.

[0066] Embodiment 1:

[0067] A nasal balloon catheter, defining the shape of the required expansion of the nasal cavity of a target object as a preset shape, the nasal balloon catheter comprising an expansion body 1 and an injection part 2 in communication with the expansion body 1.

[0068] As shown in Figures 1-2 , the expansion body 1 is a balloon 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 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 internal physiological structure of the nasal cavity of the target object, and is used to reset the nasal cavity of the target object to the preset shape;

[0069] The dilation body 1 is provided with at least one bent air passage 3, and a sealed dilation cavity is formed between the dilation body 1 and the outer wall of the air passage 3; the inner cavity of the air passage 3 is an air passage 31; one end of the air passage 31 is in communication with the outside atmosphere, and the other end of the air passage 31 is in communication with the internal airway of the nasal cavity.

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

[0071] S1: obtaining the nasal cavity image information corresponding to the nasal cavity of the target object, and forming 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 a standard nasal cavity 3D model;

[0073] S3: drawing an expected dilation body model based on the expected nasal cavity 3D model obtained in S2, and obtaining the dilation body 1 and the air passage 3 through 3D printing;

[0074] S4: assembling the injection part 2, and finally obtaining the nasal balloon catheter. The nasal balloon catheter of the embodiment is provided with the dilation body 1 having a contraction configuration and an expansion configuration, the expansion configuration of the dilation body 1 is matched with the internal physiological structure of the nasal cavity of the patient, the injection part 2 is provided, and the filling medium is input from the injection part 2 to the dilation body 1 to change the dilation body 1 from the contraction configuration to the expansion configuration. Meanwhile, the through air passage 3 is further provided in the dilation body 1, so that the internal airway of the nasal cavity can be in communication with the outside atmosphere through the air passage 31 of the air passage 3, that is, the dilation body 1 in the expansion configuration can realize the reset of the internal physiological structure of the nasal cavity, and the patient can still maintain the unobstructed breathing of the nasal cavity, thereby solving the problem of low treatment comfort caused by the nasal cavity blockage in the treatment of the existing nasal bone fracture.

[0075] Embodiment 2:

[0076] A nasal balloon catheter, the shape required for the dilation of the nasal cavity of a target object is a preset shape, and the nasal balloon catheter comprises a dilation body 1 and an injection part 2 in communication with the dilation body 1. The dilation body 1 is a capsule structure, which comprises a positioning and fixing structure 11 and a dilation structure 12; the positioning and fixing structure 11 can be supported in the nasal cavity of the target object, and the dilation structure 12 can be changed from a contraction configuration to an expansion configuration when the injection part 2 injects a filling medium; in the expansion configuration, the dilation body 1 is matched with the internal physiological structure of the nasal cavity of the target object, and is used for resetting the nasal cavity of the target object to the preset shape.

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

[0078] In addition, in this embodiment, at least part of the nasal septum positioning and 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 moving the tissues in the nasal cavity during expansion.

[0079] Example 3:

[0080] A nasal balloon catheter defines a preset shape for the expansion of a target's nasal cavity. The nasal balloon catheter includes an expander 1 and an injection section 2 communicating with the expander 1. The expander 1 is a sac-like structure, including a positioning and fixing structure 11 and an expansion structure 12. The positioning and fixing structure 11 can be supported within the target's nasal cavity, and the expansion structure 12 can transform from a contracted configuration to an expanded configuration when the injection section 2 injects a filling medium. In the expanded configuration, the expander 1 matches the internal physiological and anatomical structure of the target's nasal cavity, and is used to reposition the target's nasal cavity to the preset shape.

[0081] The difference from Embodiment 1 is that, in this embodiment, at least one ventilation conduit 3 is provided through the expander 1, and the expander 1 and the ventilation conduit 3 are integrally formed. Specifically, the outer wall surface of the section of the ventilation conduit 3 within the sac-like structure of the expander 1 can be part of the sac-like structure, forming a sealed expansion cavity between the outer walls of the expander 1 and the ventilation conduit 3, and the ventilation conduit 3 and the expander 1 can be made of the same material. Furthermore, the inner cavity of the ventilation conduit 3 in this embodiment is a ventilation channel 31, one end of which communicates with the outside atmosphere, and the other end of which communicates with the airway inside the nasal cavity.

[0082] like Figure 2 As shown, the ventilation tube 3 in this embodiment has a bent structure with a bending angle of approximately 90°, which conforms to the actual angle of the ventilation tube 3 from entering the nasal cavity to reaching the airway, making the patient's breathing smoother and further improving the patient's treatment comfort.

[0083] Example 4:

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

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

[0086] Embodiment 5:

[0087] A nasal balloon catheter, which is different from the embodiment 4 in that the number of the expansion body 1 of the present embodiment is two, and the two expansion bodies 1 correspond to the left and right nasal cavities respectively, and the expansion bodies 1 are respectively connected with the injection part 2, so as to be suitable for patients with bilateral nasal fracture, nasal cavity bleeding, nasal cavity tamponade, etc. The bilateral expansion bodies 1 can independently reduce the fracture of the corresponding side of the nasal bone.

[0088] Embodiment 6:

[0089] A nasal balloon catheter, which is different from the embodiment 1 in that the pressure of the filling medium in the expansion body 1 under the expansion configuration is 100-200 mm of mercury, which can be adjusted 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 further comprises a sensing 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, and the pressure sensor 7 and the pressure display 8 are both connected with a controller. The pressure sensor 7 is distributed on the nasal septum positioning and fitting surface a and / or the nasal bone supporting surface b. After the pressure sensor 7 senses the pressure change in the expansion body, the pressure signal is converted into an electric signal, and the signal is converted into a signal form that can be processed by a microprocessor through a signal conditioning circuit, an analog-to-digital converter, etc. integrated in the pressure display 8, and the microprocessor processes and calculates the signal and controls the pressure display 8 (which can be a common LED display screen) to display. The connection relationship of such pressure sensor 7 and pressure display 8 is a conventional connection and cooperation, which will not be described here.

[0091] The sensing unit 7 can be a conventional pressure sensor, which transmits the detected pressure signal to an external device through a wireless communication module, so as to detect the pressure of the filling medium and output the detection data. The doctor can control the amount of filling medium entering the dilation body 1 according to the value of the detection data in actual operation.

[0092] Embodiment 7

[0093] A nasal balloon catheter, which is different from the embodiment 1, has a drainage and flushing function for a patient whose nasal cavity is in a tampon state after a nasal operation. At this time, the patient has already been treated by the nasal balloon catheter, such as reduction of nasal bone fracture and nasal cavity compression hemostasis.

[0094] Specifically, as shown in Figures 5-6 The nasal septum positioning surface a, the nasal bone supporting surface b and the posterior nasal cavity supporting surface c of the dilation body 1 are provided with a plurality of drainage and flushing holes 9, which are distributed on the dilation body 1 in a manner similar to the ventilation catheter 3 and do not affect the sealing property of the dilation body 1. The drainage and flushing holes 9 have a hole diameter of about 1 mm, and part of the drainage and flushing holes 9 are in communication with the ventilation catheter 3. The nasal balloon catheter of the embodiment further comprises a drainage and flushing tube 10. One end of the drainage and flushing tube 10 extends out of the dilation body 1, and liquid medicine or normal saline can be injected into the nasal cavity from the outside through the drainage and flushing tube 10. The other end of the drainage and flushing tube 10 is in communication with part of the drainage and flushing holes 9, so that the liquid medicine or normal saline can be infiltrated into the nasal cavity through the drainage and flushing holes 9. Therefore, the drainage and flushing holes 9 of the embodiment are uniformly distributed on the dilation body 1, and form a three-dimensional network shape through the communication of the drainage and flushing holes 9 with the drainage and flushing tube 10 and / or the ventilation catheter 3.

[0095] When the dilation body 1 is expanded to a certain extent by injecting the filling medium, the drainage and flushing holes 9 will be closed due to the small hole diameter. When part of the filling medium in the dilation body 1 is extracted, the dilation body 1 shrinks, and the drainage and flushing holes 9 open, which can be used for flushing and drainage.

[0096] For the patient whose nasal cavity feels itchy, dry or has more secretions after 24 hours or 48 hours after the operation, the medical staff can extract part of the liquid in the dilation body 1 through the injection part 2, so that the balloon pressure is reduced, and the drainage and flushing holes 9 open. The secretions on the inner wall of the nasal cavity can be drained through the drainage and flushing holes 9 distributed on each surface of the dilation body 1 to the ventilation catheter 3 or the drainage and flushing tube 10 to the outside of the body. Liquid medicine or normal saline can also be injected into each drainage and flushing hole 9 through the drainage and flushing tube 10, so as to flush the inner side of the nasal cavity or perform drug treatment, and the residual liquid medicine can be discharged to the outside of the body through the ventilation catheter 3.

[0097] Embodiment 8

[0098] A nasal balloon catheter is suitable for postoperative compression hemostasis of nasal surgery or expansion treatment of nasal stenosis caused by various reasons or reduction of nasal bone fracture or postoperative ventilation drainage of nasal surgery, nasal packing shaping and other scenarios, and defines the shape of the required expansion of the patient's nasal cavity as a preset shape. The nasal balloon catheter of the embodiment includes at least one expansion body 1 and an injection part 2.

[0099] The expansion body 1 is configured to be arranged into 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 internal anatomical structure of the patient's nasal cavity to support and reduce the patient's nasal cavity to the preset shape. The injection part 2 is configured to communicate with the expansion body 1, and is configured to inject a filling medium into the expansion body 1 to change the expansion body 1 from the contracted configuration to the expanded configuration. Each expansion body 1 is provided with at least one ventilation passage 31, and the leading end of the ventilation passage 31 is connected to the outside atmosphere, and the trailing end of the ventilation passage 31 is communicated to the internal airway of the patient's nasal cavity.

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

[0101] In the embodiment, in the case of treating unilateral nasal bone fracture, nasal stenosis and the like, the number of the above-mentioned expansion body 1 can be one (i.e. only a single nasal cavity needs to be supported). While for the treatment of bilateral nasal bone fracture, nasal stenosis and the like, the number of the above-mentioned expansion body 1 can be two, corresponding to the left and right nasal cavities of the patient respectively, thereby supporting the two nasal cavities.

[0102] In the 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, i.e. the positioning and fixing structure 11 fixes the relative position of the expansion body 1 and the nasal cavity by cooperating with the inner wall structure of the nasal cavity, and the expansion structure 12 expands under the action of the filling medium to prop up the nasal bone or other internal structures of the nasal cavity, so that the patient's nasal cavity reaches the above-mentioned preset shape.

[0103] Further, the outer wall surface of the above-mentioned expansion body 1 can be configured to include a nasal septum positioning and fitting surface facing the nasal septum, a nasal bone supporting surface facing the ala nasi, and a posterior nasal cavity supporting surface facing the oral cavity. The nasal septum positioning and fitting surface can be provided 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 provided as the above-mentioned expansion structure 12. The thickness of the nasal septum positioning and fitting surface is greater than that of the nasal bone supporting surface and the posterior nasal cavity supporting surface, that is, the nasal septum positioning and fitting surface can be thickened to have strong mechanical properties, thereby playing a fixing role and serving as a mechanical supporting surface, while the nasal bone supporting surface and the posterior nasal cavity supporting surface can be thin, thereby having a certain elasticity and being capable of expanding under the action of the filling medium to serve as a force surface for supporting the nasal cavity part to be lifted.

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

[0105] In the present embodiment, at least part of the nasal septum positioning and fitting surface can be configured as a rough surface (anti-slip design), and the thickening and anti-slip design can increase the friction and improve the fixing capacity; at least part of the nasal bone supporting surface can be provided with an anti-adhesion coating, and the thinning and anti-adhesion coating design can increase the expansion capacity and avoid moving the nasal cavity tissue during expansion.

[0106] In the present embodiment, the nasal cavity balloon catheter further includes a ventilation catheter 3, which penetrates the expansion body 1, and the ventilation cavity of the ventilation catheter 3 is the above-mentioned ventilation passage 31. That is, the expansion body 1 can be provided as a balloon structure surrounding the ventilation catheter 3, and the balloon 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 the effects of anti-slip and water absorption. The water-absorbing resin can absorb a large amount of water and belongs to a new type of functional polymer material, which has strong moisturizing properties. The water-absorbing resin is non-toxic and non-irritating, and does not react after contacting with human skin, and does not have a great impact on the environment, so it has been widely used in medical, industrial, health and other fields.

[0107] Further, in order to improve the patient's experience, the end of the ventilation catheter 3 extending into the patient's nasal cavity is provided with an avoidance bevel angle, that is, to avoid the end of the ventilation catheter 3 from hitting the tissue in the patient's nasal cavity. Specifically, for the nasal cavity of a child patient, the length of the ventilation catheter 3 extending out of the capsule structure can be 2mm to 5mm, and the diameter of the ventilation catheter 3 can be 3mm to 5mm; for the nasal cavity of a teenager patient, the length of the ventilation catheter 3 extending out of the capsule structure can be 3mm to 6mm, and the diameter of the ventilation catheter 3 can be 4mm to 6mm; for the nasal cavity of an adult patient, the length of the ventilation catheter 3 extending out of the capsule structure can be 4mm to 7mm, and the diameter of the ventilation catheter 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 segment of the ventilation catheter 3 in the capsule structure can be part of the capsule structure, and the ventilation catheter 3 and the expansion body 1 can be made of the same material.

[0109] In this embodiment, for the case where the number of expansion bodies 1 is one, the injection part 2 described above can be specifically an injection tube, the diameter of which can be set to be smaller than the inner diameter of the ventilation catheter 3, and the injection tube can be arranged to fit on the inner wall surface of the ventilation catheter 3, and one end of the injection tube can be arranged to penetrate through the ventilation catheter 3 to communicate with the inner cavity of the expansion body 1 (of course, in other embodiments, the injection tube can also be arranged to communicate with the inner cavity of the expansion body 1 through a connecting interface on the expansion body 1 or be directly fixedly connected to the expansion body 1), and the other end can be arranged to extend out of the ventilation catheter 3 to connect with the external filling medium supply end 4 (such as an injection flask filled with filling medium).

[0110] In this embodiment, for the case where the number of expansion bodies 1 is two, the two expansion bodies 1 correspond to the left and right nasal cavities respectively, and the expansion bodies 1 are respectively connected with the injection parts 2, so as to be suitable for patients with bilateral nasal fractures, and the bilateral expansion bodies 1 can independently fracture the corresponding side nasal bones. In addition, the two injection parts 2 can be independently connected with the filling medium supply end 4, and the two balloon catheters can also be respectively fixed by being sleeved on the patient's ears through the ear clamping assembly 6.

[0111] In this embodiment, in order to ensure that the support force inside the nasal cavity meets the treatment requirements, under the expansion configuration, the filling medium pressure in the above-mentioned expansion body 1 (capsule structure) can be 100mmHg-200mmHg, and the filling medium pressure for adult patients can be relatively wide, and the specific value depends on the applicable disease; and the filling medium pressure for child patients can be set to be relatively low, for example, 100mmHg-150mmHg, so as to avoid unnecessary irritation or damage to the nasal cavity of the child, and the specific value also needs to be adjusted according to the age, weight and condition of the child.

[0112] In the embodiment, the nasal balloon catheter can further comprise a sensing unit for detecting the pressure of the filling medium in the dilatation body 1. The sensing unit of the embodiment comprises a pressure sensor 7 arranged in the inner cavity of the dilatation body 1 or on the surface corresponding to the dilatation structure 12 described above, for detecting the pressure of the filling medium and outputting a pressure signal. The sensing unit further comprises a pressure display 8 for displaying 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 dilatation body 1 according to the numerical value of the detection data during actual operation. Further, the pressure sensor 7 described above can also be arranged on the injection part (the injection tube described above), and the detection of the pressure of the filling medium can be realized. In the embodiment, the filling medium described above can be a fluid, specifically air or water. In the embodiment, the nasal balloon catheter can further comprise an injection plug, which can be configured to block the filling medium inlet on the dilatation body 1 or block the input end of the injection part 2 described above.

[0113] The nasal balloon catheter of the embodiment can be specifically applied to compression hemostasis (by expanding the dilatation body 1 to compress the nasal mucosa to achieve the purpose of hemostasis), nasal adhesion / narrowing (by expanding the dilatation body 1 to expand the space and enlarge the narrow nasal cavity), collapsed nasal bone fracture (by expanding the dilatation body 1 to reset the collapsed nasal bone), drainage ventilation (changing the traditional treatment method of iodoform oil sand strip, which is not ventilated in the nostril and the patient is uncomfortable; the shape of the tampon is in a lump, which is not consistent with the normal physiological nasal cavity; while achieving the functions of “compression hemostasis”, “dilation of nasal cavity” and “resetting of nasal bone”, the nasal balloon catheter can also play the function of drainage ventilation), and the like.

[0114] Embodiment 9:

[0115] The embodiment provides a preparation method of 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 cavity image information corresponding to the nasal cavity of the volunteer is acquired, and a first nasal cavity 3D model is formed based on the nasal cavity image information. The nasal parts of volunteers of different ages are selected, who have no history of chronic upper respiratory tract disease, no history of nasal trauma and surgery, no history of acute upper respiratory tract disease in the past 3 months, and no signs of nasal disease or significant anatomical abnormalities are selected by applying the front nasal mirror and nasal endoscope (note: except for those who have no nasal disease and dysfunction but have significant nasal septum deviation). The volunteers are scanned continuously in the coronal position after being quiet for 30 minutes in a room temperature environment (about 20°C), the range is from the nasal tip to the posterior wall of the nasopharynx, the layer thickness is 3mm, the layer spacing is 3mm, and the window position is selected for soft tissue window. The obtained DICOM image data is converted into BMP format images by using the software of Siemens multi-slice spiral CT machine. The BMP format images obtained above are digitized by using the image reading function of Matlab software, the boundaries of the nasal cavity airway are recognized by using the self-compiled program, and they are imported into Ansys 6.1 software, and the surface three-dimensional reconstruction of the nasal airflow channel and the maxillary sinus cavity is performed by using the pre-processing function of the software. The key points of each layer that can accurately reflect the basic structural characteristics of the nasal airflow channel and the maxillary sinus cavity are connected into a line by using the pre-processing function of the finite element analysis software Ansys 6.1, and the surface and body are further constructed in sequence, and the tetrahedral element is selected to perform finite element section on the entire nasal airflow channel and the maxillary sinus cavity, and the digital reconstruction of the airflow channel and the maxillary sinus cavity is completed. Finally, the expected expansion body model is drawn based on the expected nasal cavity 3D model, and the expansion body 1 and the ventilation catheter 3 of the nasal balloon catheter are obtained by 3D printing. When printing the expansion body 1, the filling medium inlet for assembling the injection part 2 is left out, and finally the injection part 2 is assembled, and the nasal balloon catheter is obtained.

[0117] Example 10:

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

[0119] 1. Unilateral nasal bone fracture: under local / general anesthesia, adults can use 1% tetracaine soaked cotton to perform nasal mucosa surface anesthesia, and children are given general anesthesia. Then, one nasal balloon catheter is placed in the nasal cavity of the fractured nasal bone on one side, and is pressed to 150mmHg (the specific pressure is determined according to the patient's condition). The expansion time is 2 minutes, the balloon is depressurized, and the low pressure state is maintained. The index finger and thumb of the other hand are used to assist in the nasal bone reduction, and the reduction success is observed under the nasal endoscope, the nasal bone protrusion is observed from the outside of the nose, the bone rubbing sound is heard, and the nasal cavity can be packed after the operation.

[0120] 2. Bilateral nasal bone fracture: Adults can use 1% tetracaine soaked cotton to perform nasal mucosa surface anesthesia, and children are anesthetized. Then place two nasal balloon catheters in the nasal cavity of the fractured nasal bone, respectively, and press to 150 mm Hg (the specific pressure is determined according to the patient's condition), expand for 2 minutes, deflate the balloon, and keep it in a low pressure state. With the index finger and thumb of the other hand, assist in nasal bone reduction, observe the success of reduction under nasal endoscopy, observe the nasal bone protrusion from the outside of the nose, and hear the bone rubbing sound. Nasal packing can be performed after operation.

[0121] The above description of the embodiments is to facilitate those of ordinary skill in the art to understand and use the invention. Those skilled in the art can obviously make various modifications to these embodiments, and apply the general principles described herein to other embodiments without having to go through creative labor. Therefore, the present invention is not limited to the above embodiments, and any improvements and modifications made by those skilled in the art within the scope of the present invention should be within the scope of protection of the present invention.

Claims

1. A nasal balloon catheter, comprising: The shape of the nasal cavity of the target object required to be expanded is a preset shape, and the nasal cavity balloon catheter comprises an expansion body (1) and an injection part (2) in communication with the expansion body (1); The expansion body (1) comprises a positioning and fixing structure (11) capable of being supported in the nasal cavity of the target object and an expansion structure (12) capable of being 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 internal physiological structure of the nasal cavity of the target object and is used for resetting the nasal cavity of the target object to the preset shape; At least one ventilation conduit (3) is provided in the expansion body (1), and a sealed expansion cavity is formed between the expansion body (1) and the outer wall of the ventilation conduit (3); the inner cavity of the ventilation conduit (3) is a ventilation passage (31); one end of the ventilation passage (31) is in communication with the atmosphere, and the other end of the ventilation passage (31) is in communication with the internal airway of the nasal cavity; 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 alae nasi, and a posterior nasal cavity supporting surface facing the oral cavity; wherein the nasal septum positioning and fitting surface is the positioning and fixing structure (11), the nasal bone supporting surface and the posterior nasal cavity supporting surface are the expansion structure (12); the thickness of the nasal septum positioning and fitting surface is greater than that of the nasal bone supporting surface and the posterior nasal cavity supporting surface, and at least part of the nasal septum positioning and fitting surface is a rough surface; one end of the ventilation conduit (3) extending into the nasal cavity of the patient is provided with an avoidance inclined angle.

2. The nasal balloon catheter of claim 1, wherein, The thickness of the nasal septum positioning and fitting surface is 1-5mm, the thickness of the nasal bone supporting surface is 0.5-2mm, and the thickness of the posterior nasal cavity supporting surface is 0.5-2mm.

3. The nasal balloon catheter of claim 1, wherein, At least part of the nasal bone supporting surface is provided with an anti-adhesion coating.

4. The nasal balloon catheter of claim 1, wherein, The injection part (2) is connected with an external filling medium supply end (4), and the filling medium supply end (4) is connected with a driving member (5) for driving the filling medium to flow to the expansion body (1).

5. The nasal balloon catheter of claim 1, wherein, The nasal cavity balloon catheter further comprises an ear clamping assembly (6) comprising a supporting rod (61) connected with the filling medium supply end (4) and an ear fixing member (62) connected with the supporting rod (61).

6. The nasal balloon catheter of claim 1, wherein, In the expanded configuration, the pressure of the filling medium in the expansion body (1) is 100-200mmHg; The filling medium is selected from air or water.

7. The nasal balloon catheter of claim 1, wherein, The nasal cavity balloon catheter further comprises a sensing 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), and the pressure sensor (7) and the pressure display (8) are connected with a controller.

8. The nasal balloon catheter of claim 1, wherein, 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 with the injection part (2).

9. A method of making a nasal balloon catheter according to any one of claims 1-8, characterized in that, The method comprises the following steps: S1: obtaining nasal cavity image information corresponding to the nasal cavity of the target object, and forming 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 a standard nasal cavity 3D model; S3: based on the expected nasal cavity 3D model obtained in S2, an expected dilator model is drawn, and the dilator (1) and the ventilation catheter (3) are obtained through 3D printing; S4: the injection part (2) is assembled, and finally the nasal balloon catheter is obtained.

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