Maxillary sinus fracture restoration and support device

Abstract

The present invention relates to a fracture restoration and support device and, more specifically, provides a fracture restoration and support device, using a tube unit and a balloon, to be installed in the maxillary sinus below a fractured orbital floor and support the orbital floor and maxillary anterior wall that are surgically repositioned.

Description

Maxillary sinus fracture restoration and support device

[0001] The present invention relates to a fracture restoration and support device, and more particularly, to a fracture restoration and support device that is installed in the maxillary sinus below a fractured inferior orbital wall (upper maxillary wall) and supports the surgically reduced inferior orbital wall and anterior maxillary wall.

[0002] In general, an orbital fracture is a fracture that occurs in the orbital bone that forms the eye socket due to external impact on the area around the eye. It often occurs alone in the inferior or inner wall of the orbit, or it can occur simultaneously in the inferior and inner walls.

[0003] If orbital fractures are not restored to normal through surgery, complications such as double vision and sunken eyes due to eye movement disorders may occur.

[0004] When an orbital fracture occurs, if the extent of the fracture is wide and the orbital wall bone loss is severe, orbital wall reconstruction surgery is performed. First, the orbital soft tissue that has escaped to the ethmoid sinus and maxillary sinus outside the orbit through the fracture site is restored to its original position within the orbit, and then the fractured orbital bone fragments are restored to their original shape.

[0005] At this time, since the orbital bone is made of thin bone with a thickness of about 1 to 2 mm, it is difficult to restore and fix the thin orbital bone fragments that have been fractured into several pieces to their original position. Therefore, most surgeons do not restore the fractured orbital bone fragments to their original position, but leave them in a fractured state and replace the orbital wall with an artificial implant (polyethylene plate, titanium plate, or absorbable plate).

[0006] Among the above artificial implants, the polyethylene plate and titanium plate permanently replace the bone at the site of the orbital fracture and exist within the eye, and the absorbable plate acts as a substitute for the orbital wall until the fractured orbital wall is fused and restored.

[0007] However, when the orbital wall is restored by replacing it with an artificial implant, the artificial implant that remains in the orbit for decades has a high risk of secondary infection if inflammation such as rhinitis or sinusitis occurs in the surrounding maxillary and ethmoid sinuses, and complications such as prolapse into the ethmoid and maxillary sinuses may occur after a long period of time.

[0008] In addition, if a titanium plate, which is a hard metal material, is used for restoration, there is a high risk of eye damage due to the implant if a secondary accident occurs around the patient's eye.

[0009] In addition, when a flat artificial implant is used to replace an orbital fracture in orbital fracture surgery, the original natural orbital wall curvature may not be accurately restored, which may cause complications such as double vision or enophthalmos, making the two eyes appear to be different sizes.

[0010] Therefore, in the case of orbital fracture, it is safer to restore the orbital fracture using the patient's own fractured orbital wall bone fragments.

[0011] For prior art, please refer to Patent Publication No. 10-2019-0093762 (August 12, 2019).

[0012] The present invention is a device that helps to restore fractured inferior orbital wall bone fragments to their original positions by inserting a balloon into the maxillary sinus through the maxillary ostium of the nasal cavity during facial fracture restoration surgery, particularly orbital fracture restoration surgery, and expanding the balloon, and then maintaining the balloon support device in the maxillary sinus for several days thereafter to help heal the inferior orbital wall fracture with the patient's own fracture fragments.

[0013] This device can be used to restore the orbital inferior wall bone defect caused by an orbital fracture using the patient's own orbital inferior wall bone fragment, thereby reducing or completely eliminating the bone defect size. In orbital fracture surgery, it can be restored using a relatively small-sized artificial implant, or when complete recovery is achieved using the patient's orbital bone fragment, an artificial implant can be omitted altogether.

[0014] In addition, the purpose is to provide a fracture restoration support device that can restore orbital fractures using the patient's own orbital bone fragments and reduce long-term complications such as inflammation and implant dislodgement.

[0015] According to one embodiment of the present invention, a fracture restoration support device including a tube portion and a balloon is provided.

[0016] The effects of the fracture restoration support device according to the present invention are as follows.

[0017] The fracture restoration support device is inserted into the maxillary sinus through the nasal cavity through the maxillary sinus foramen without additional incision during surgery, and then positioned inside the maxillary sinus. Then, through balloon expansion, the bone fragments of the orbital inferior wall fracture are restored to their original position using the patient's own orbital wall bone fragments. The shape of the fractured orbit can be restored to its original state using the patient's own orbital wall bone fragments, and the size of the inferior wall bone defect caused by the orbital fracture can be reduced or completely eliminated.

[0018] Therefore, in orbital fracture surgery, a relatively small-sized artificial implant can be used to restore the fracture, or if complete inferior wall fracture restoration is achieved and there is no bone defect, an artificial implant can be omitted altogether.

[0019] Furthermore, orbital fractures are reconstructed using a piece of the patient's own orbital bone, reducing complications such as inflammation. This is expected to be particularly helpful for pediatric patients requiring long-term prosthetic implant use, immunocompromised patients at high risk for inflammation, and patients with sinusitis or rhinitis in the periorbital area, who are at high risk for prosthetic-induced inflammation.

[0020] Additionally, a balloon inserted into the maxillary sinus can be used to support the inferior orbital wall in cases of orbital wall fracture, and can also be used to support depressed fractures of the outer maxillary wall, such as the anterior maxillary wall.

[0021] Figure 1 is an exemplary diagram showing a state of use of a fracture restoration support device according to one embodiment of the present invention.

[0022] FIG. 2 is a plan view illustrating a fracture restoration support device according to one embodiment of the present invention.

[0023] Figure 3 is an exemplary diagram showing the installation state of a fracture restoration support device according to one embodiment of the present invention.

[0024] The present invention provides a maxillary sinus fracture restoration support device including a tube and a balloon installed in the maxillary sinus below the fractured orbital inferior wall to support the surgically corrected orbital inferior wall and maxillary anterior wall.

[0025] Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the attached drawings. Prior to this, it should be noted that the terms and words used in this specification and claims should not be construed as limited to their conventional or dictionary meanings. Based on the principle that the inventor can appropriately define the concept of a term to best explain his or her invention, they should be construed as meanings and concepts consistent with the technical spirit of the present invention.

[0026] Therefore, the embodiments described in this specification and the configurations illustrated in the drawings are only the most preferred embodiments of the present invention and do not represent all of the technical ideas of the present invention. Therefore, it should be understood that there may be equivalent modified examples that can replace them at the time of filing this application.

[0027] The present invention relates to a fracture restoration and support device that enables fracture fragments of damaged fractures such as fractures and depressions to be restored to their original positions. The configuration of the present invention will be described in detail below with reference to the drawings.

[0028] Fig. 1 is an exemplary diagram showing a state of use of a fracture restoration support device according to an embodiment of the present invention. Specifically, Fig. 1 (a) is an exemplary diagram showing a state of use of a fracture restoration support device according to an embodiment of the present invention, and Fig. 1 (b) is a CT image showing a state of use of a fracture restoration support device according to an embodiment of the present invention.

[0029] As illustrated in FIG. 1, a support device (200) for bone structure reconstruction according to one embodiment of the present invention includes a tube portion (210) and a balloon (220).

[0030] The tube portion (210) functions as a passage for the filling liquid injected into the balloon (220) to move, and also functions as a passage for draining bodily fluids or discharges from the maxillary sinus or its surrounding area to the outside of the body during bone structure reconstruction. The configuration of the tube portion (210) will be described later with reference to FIG. 2.

[0031] The balloon (220) passes through the nasal cavity and maxillary sinus of a patient with damaged bone structure in a contracted state and enters the maxillary sinus of the patient.

[0032] After the above entry, the liquid for filling the balloon is introduced into the balloon (220) through the tube portion (210), and accordingly, the balloon (220) expands in volume inside the maxillary sinus.

[0033] The inflated balloon (220) supports bone structures that have been damaged by fracture, collapse, etc. and displaced from their normal positions to be returned to their original positions, thereby assisting in the recovery and support of the fracture.

[0034] The bone structure supported by the balloon (220) may be, for example, the inferior orbital wall (upper maxillary wall) and / or the anterior maxillary wall, but it is of course possible to restore other bone structures of the outer and inner walls surrounding the maxilla outside of the above-mentioned areas using the present invention.

[0035] FIG. 2 is a plan view illustrating a fracture restoration support device according to one embodiment of the present invention.

[0036] As previously described with reference to FIG. 1, a fracture restoration support device (200) according to one embodiment of the present invention includes a tube portion (210) and a balloon (220).

[0037] The tube section (210) includes a first euro (211) and a second euro (212), and the first and second euros (211, 212) can be arranged inside one flexible tube (not shown in the drawing).

[0038] The first flow path (211) functions as a flow path through which the balloon filling liquid flows into the balloon (220). After the balloon (220) is inserted in a contracted state into the maxillary sinus through the patient's nasal cavity and maxillary sinus, the balloon filling liquid flows into the balloon (220) through the first flow path (211) to expand the volume of the balloon (220) and support the restoration of the patient's damaged fracture fragment.

[0039] At this time, the liquid flowing into the balloon (220) through the first euro (211) may be, for example, saline solution, but of course, other liquids may also be possible.

[0040] The second euro (212) functions as a passage for draining body fluids (blood, etc.) and exudates (exudate, etc.) within the maxillary sinus.

[0041] The first flow path (211) and the second flow path (212) of the tube section (210) must pass through the nasal cavity and maxillary sinus formed by a curved passage, and therefore must be made of a flexible material.

[0042] In addition, it is important that the first urea (211) and the second urea (212) have an appropriate diameter. Here, an appropriate diameter means a diameter that is wide enough to allow a sufficient amount of liquid to flow and prevent internal blockage of the tube portion (210) by foreign substances, while at the same time having a diameter that is narrow enough to pass through the patient's nasal cavity and maxillary sinus without difficulty.

[0043] The appropriate diameter of the first euro (211) and the second euro (212) may be, for example, 6 to 15 Fr (French), and preferably 10 to 12 Fr.

[0044] For example, the material of the first euro (211) and the second euro (212) may be transparent silicone, but it is of course possible to manufacture the first euro (211) and the second euro (212) using materials other than transparent silicone.

[0045] When the first flow path (211) and the second flow path (212) are manufactured using transparent silicone, the first flow path (211) and the second flow path (212) are formed flexibly so that they can be easily inserted into the patient's maxillary sinus through the nasal cavity and maxillary sinus, and at the same time, the inside of the first flow path (211) and the second flow path (212) can be observed from the outside.

[0046] That is, the inflow or outflow of the balloon filling liquid passing through the first passage (211) can be observed, and the discharge of the patient's body fluid or body waste passing through the second passage (212) can be observed. Accordingly, there is an advantage in that the internal condition of the patient's maxillary sinus can be quickly and intuitively identified during bone reconstruction surgery.

[0047] One end of the first euro (211) is connected to a balloon (220), and an injection port (213) is formed at the other end of the first euro (211).

[0048] During the bone reconstruction process, the liquid for filling the balloon is introduced into the injection port (213), passes through the first flow path (211), and is filled into the balloon (220). At this time, the injection port (213) can be connected to a separate syringe containing the liquid for filling the balloon.

[0049] In addition, as an example, a plug (not shown in the drawing) may be formed in the injection port (213) to enable opening and closing of the end of the first euro (211).

[0050] A communication hole (2121) is formed at one end of the second flow path (212) to be positioned so as to communicate with the internal space of the patient's maxillary sinus during bone reconstruction, and a drainage port (214) is formed at the other end of the second flow path (212).

[0051] During the bone reconstruction process, the fluid and discharge existing in the patient's maxillary sinus are introduced into the communication hole (2121), passed through the second flow path (212), and discharged into the drainage port (214).

[0052] In addition, as an example, a plug (not shown in the drawing) may be formed in the drainage port (214) so ​​as to be able to open and close the end of the second flow path (212). The plugs formed in the injection port (213) and the drainage port (214) are formed so as to be able to close the openings formed at the ends of the injection port (213) and the drainage port (214), thereby preventing contamination of the first flow path (211), the second flow path (212), and the internal space of the balloon (220).

[0053] A fixing member (215) for preventing the tube part (210) from flowing may be placed in the first and second flow paths (211, 212) of the tube part (210) or in the other end region of the flexible tube body surrounding the first and second flow paths (211, 212) (i.e., the region adjacent to the region where the injection port (213) and the drainage port (214) are formed).

[0054] At this time, the fixed part (215) may be configured to be fixed to the patient's cheek, etc., for example, with an adhesive structure, but may also be configured with other components such as forceps or a ring that can prevent movement of the tube part (210).

[0055] Additionally, it is desirable that the tube portion have an appropriate overall length.

[0056] If the tube part is too long, the tube and drainage port exposed to the outside may remain long, which may cause discomfort to the patient when fixed to the cheek. If the tube part is too short, it may be difficult to fix the drainage port to the cheek.

[0057] At this time, the desired overall length of the tube part may be approximately 16 to 18 cm, but since the length from the nasal cavity to the inside of the maxillary sinus differs for each patient, the above figure may be appropriately changed depending on the situation.

[0058] In addition, for example, the length of the tube portion (210) introduced into the nasal cavity may be about 10 or 11 cm, the length of the tube portion (210) outside the nasal cavity may be about 2 to 3 cm, and the length of each port (213, 214) may be about 3 to 4 cm, but the above figures may be appropriately changed depending on the situation.

[0059] The balloon (220) is a structure that supports the patient's inferior orbital wall structure and the anterior maxillary sinus wall structure during the bone reconstruction process.

[0060] The balloon (220) can exist in a contracted state in which there is no filling liquid in the internal space of the balloon (220) and in an expanded state in which the filling liquid is filled in the internal space of the balloon (220).

[0061] In the process of bone reconstruction surgery and treatment, the inside of a balloon (220) inserted into the patient's maxillary sinus is filled with a filling liquid so that the balloon (220) becomes inflated, and the patient's orbital inferior wall structure and the maxillary sinus anterior wall structure are supported by the balloon (220) and the balloon filling liquid injected into the inside of the balloon (220), thereby performing fracture restoration and support.

[0062] The balloon (220) may be made of, for example, a radiopaque material that is harmless to the human body, but may also be made of an elastic material other than the above material.

[0063] If the balloon (220) is made of a radiopaque material, there is an advantage in that the balloon (220) inserted into the maxillary sinus can be observed via X-ray after surgery without using radiopaque dye.

[0064] In addition, it is preferable that the balloon (220) be made of a material with sufficient durability. If the balloon (220) is formed of a material that is prone to bursting, there is a risk that it may burst due to a screw tip for bone fixation, a bone protrusion within the maxillary sinus, or a bone fragment with a sharp end.

[0065] The above balloon (220) can support the bone structure of the patient's orbital inferior wall structure and the outer wall of the maxillary sinus in a state in which it is inflated to a size of, for example, about 10 to 20 cc as the liquid for filling the balloon is introduced during the bone reconstruction process.

[0066] Figure 3 is an exemplary diagram showing the installation state of a fracture restoration support device according to one embodiment of the present invention.

[0067] Hereinafter, with reference to FIGS. 1 to 3, a process of restoring and supporting a fracture of a patient with bone damage through a fracture restoration support device (200) according to one embodiment of the present invention will be described.

[0068] First, a balloon (220) in a deflated state is inserted into the maxillary sinus through the patient's nasal cavity and maxillary sinus.

[0069] Thereafter, a syringe containing liquid for filling the balloon is connected to the injection port (213), and the liquid for filling the balloon is introduced into the balloon (220) through the injection port (213) and the first flow path (211). At this time, bodily fluids and wastes in the patient's maxillary sinus can be discharged through the second flow path (212).

[0070] When the balloon (220) is filled with the balloon filling liquid, the patient's inferior orbital wall and the inner wall of the maxillary sinus are maintained in the correct position by the balloon (220) and the balloon filling liquid.

[0071] After several days in this state, the broken bone fragments from the fracture fuse together and the bone structure is rebuilt.

[0072] Afterwards, a syringe is connected to the injection port (213) of the first euro (211), the saline solution injected into the balloon (220) is recovered using the syringe, and the fracture restoration support device (200) is removed from the patient.

[0073] While the present invention has been described with reference to the embodiments illustrated in the drawings, these are merely exemplary, and those skilled in the art will appreciate that various modifications and equivalent alternative embodiments are possible. Therefore, the true scope of technical protection of the present invention should be determined by the technical spirit of the appended claims.

Claims

1. A maxillary sinus fracture restoration support device including a tube and a balloon.

2. In claim 1, A maxillary sinus fracture restoration support device, characterized in that the tube portion includes a first tube and a second tube.

3. In claim 2, A fracture restoration support device, characterized in that the first tube and the second tube are formed of a flexible material.

4. In claim 2, A fracture restoration support device, characterized in that the first tube and the second tube are accommodated inside a flexible tube body.

5. In claim 2, A fracture restoration support device, characterized in that the first tube is formed of a transparent material.

6. In claim 2, A fracture restoration support device, characterized in that the second tube is formed of a transparent material.

7. In claim 2, A fracture restoration support device characterized in that one end of the first tube is connected to a balloon, and an injection port is formed at the other end of the first tube so that a liquid for balloon injection is introduced.

8. In claim 7, A fracture restoration support device, characterized in that the liquid for the balloon injection is saline solution.

9. In claim 2, A fracture restoration support device, characterized in that a communication hole communicating with the outside of the second tube is formed at one end of the second tube, and a drainage port is formed at the other end of the second tube.

10. In claim 1, A fracture restoration support device, characterized in that the above balloon is made of a radiopaque material.

11. In claim 1, A fracture restoration support device characterized in that the diameter of the above tube portion is 10 to 12 Fr.

12. In claim 1, A fracture restoration support device, characterized in that a fixing part is formed in the above tube part to prevent movement of the above tube part.

13. A fracture restoration support device according to claim 12, characterized in that the fixing part is an adhesive fixing part.

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