KR102061194B1 - Nasal implant for nasal surgery - Google Patents

Abstract

According to an embodiment, the present invention relates to a prosthesis for a nasal surgery comprising: a pillar unit formed of polycaprolactone (PCL) and having a plurality of penetration holes on a body thereof; a first fixing unit coupled to one side surface of the pillar unit; and a second fixing unit coupled to the other side surface of the pillar unit. In addition, a tail side unit of septal cartilage is positioned in a fixing groove specified between the first and second fixing units. Moreover, the tail side unit is fixed by a suture thread penetrating the plurality of penetration holes on the first and second fixing units. The first and second fixing units are formed of a PCL material same as the material for the pillar unit. Therefore, the prosthesis for a nasal surgery using PCL, which is safe for infection by bacteria and has sufficient stiffness, can maintain the shape and functions of the nose of a patient even after a surgery for long time.

Description

Nasal Surgery Inserts {NASAL IMPLANT FOR NASAL SURGERY}

The present invention relates to a nasal surgical insert, and more particularly to a nasal surgical insert using a polycaprolactone (PCL).

Since the nose occupies the center of the face and plays a decisive role in forming facial contours and overall impressions, more people are trying to perform nose surgery. In addition to these aesthetic purposes, people also want to perform nasal surgery when a part of the nose is damaged due to an injury or when the shape of the nose is not natural or acquired. Nasal surgeries to raise the nose, orthodontic rhinoplasty to correct the nasal tip, and nasal septal graft nasal surgery to improve the structural integrity of the skeletal constituting the nasal valve by strengthening the nasal cavity are performed.

In particular, the nasal valve, which is a narrow organ inside the nose, acts as a central part of the nose to control breathing by allowing air flow into and out of the nose. If the non-valve is constricted due to anatomical glandular or acquired abnormalities such as septal curvature, nasal congestion may occur. In order to solve these symptoms, the structural integrity of the skeleton constituting the nasal valve should be improved. As one of the improvement methods, surgery to expand the nasal septum by reinforcing the nasal cavity through implantation has been used.

On the other hand, for the nasal augmentation of the nose, medical silicone or Gore-Tex is generally used as an artificial material inserted into the nose. In addition, polyethylene terephthalate, Proplast I and II (trade name Medpore ) May be used. By the way, these materials are hard materials that are inserted outside the nose and may be suitable for raising the nose as a whole.However, the inside of the nose is applied to reinforce the nasal cavity to relieve nasal valve stenosis due to problems such as protrusion and inflammatory reaction. It's hard to be.

Due to these problems, a method of using autologous cartilage, which is relatively hard, is used to expand the nasal septum by reinforcing the nasal passages. In the existing surgery to reinforce the nasal cavity, a part of the nasal septum cartilage of the patient is cut and processed according to the use, or the rib cartilage is collected and processed from the patient, and then the method is used as a pillar to reinforce the nasal cavity. However, in the case of using autologous cartilage such as septal cartilage or rib cartilage of a patient, cartilage may be infected with bacteria, and deformation or melting may be absorbed, resulting in deformation of the nose shape.

In addition, since the cartilage is artificially increased during autologous transplantation during surgery, the autologous cartilage implanted in the postoperative intraoperative cartilage has a force to return to the original low nasal state, that is, downward pressure. It is easy to bend or damage the cartilage after surgery due to insufficient stiffness, and after a long time, the cartilage may be displaced from the original surgical position.
Korean Patent Publication No. 10-1505385 relates to a cartilage support, wherein a plurality of support legs are formed at both ends of the support body at both sides, so that the support body can stand evenly if the support body is standing on the basis of the trabecular or nasal septum that is the support point. To help. However, the above patent has a problem that the support structure as a prosthesis at the time of molding can form a simple and stable structure, but can not properly cope with the nose height of the patient during surgery.

The present invention is to solve the above-described technical problem, an object of the present invention is to use a prosthesis instead of the patient's cartilage to perform nose surgery in a simple procedure without damaging the cartilage or other body parts of the patient. In addition, to provide a nose surgical insert that can be adjusted in length during the surgery to the height of the patient's nose.

Nasal surgical insert according to an embodiment of the present invention, the pillar portion is formed of a polycaprolactone (PCL) material and having a plurality of through holes in the body; A first fixing part coupled to one side of the pillar part; And a second fixing portion coupled to the other side of the pillar portion, wherein a trailing side portion of a septal cartilage is located in a fixing groove defined between the first and second fixing portions, and the trailing side portion is formed of the second fixing portion. It is secured with a suture passing through a plurality of through holes in the first and second fixing portions, wherein the first and second fixing portions are formed of the same PCL material as the pillar portion.

In an embodiment, the pillar has a configuration for being fixedly coupled between the two non-wing cartilage. The total length of the pillar portion and the first and second fixing portions may be determined according to a coupling position of the through hole of the pillar portion and the first and second fixing portions. The first fixing part and the first and second fixing parts may be integrally combined and manufactured. The PCL material may be composed of a gamma sterilized porous PCL mesh. The PCL mesh has a porous interconnect structure with a lay-down pattern of 0 °, 60 °, and 120 °.

According to an embodiment of the present invention, by providing a prosthesis that is used instead of the autologous cartilage of the patient in performing nasal surgery to reinforce the nasal cavity to improve the function of the non-valve, it is simple without damaging the cartilage or other body parts of the patient The procedure can be performed nose surgery. In addition, the present invention provides a nasal surgical insert using a PCL (polycaprolactone) that is safe and stiff enough for bacterial infection instead of autologous cartilage that is vulnerable to bacterial infection and does not have sufficient rigidity. The function can be maintained for a long time.

1 is a view showing the outside of a person's nose.
2 to 4 are views showing the inside of a person's nose.
5 and 6 are views showing the nose surgical insert according to an embodiment of the present invention by way of example.
Figure 7 is a photograph showing a PCL mesh used in the nose surgical insert according to an embodiment of the present invention.
8 and 9 are views for explaining the process of the nose surgical insert according to the present invention is inserted into the nose to be combined and fixed with the surrounding tissue.
10 is a view showing the nose surgical insert according to another embodiment of the present invention.

Hereinafter, embodiments of the present invention will be described clearly and in detail so that those skilled in the art can easily carry out the present invention.

1 is a view showing the outside of a person's nose. Referring to FIG. 1, the outside of a person's nose includes a nostril 12 extending from the nose root 11 to the tip of the nose 14, the nostrils 13 roundly positioned on both sides of the nose, both nostrils 15 and both nostrils. It is located in between is composed of a column (columella, 16) and the like to serve as a nose post to support the tip of the nose (14).

2 to 4 are views showing the inside of a person's nose. Referring to FIGS. 2 and 3, the inside of a person's nose is a septal cartilage 20, a lower lateral cartilage 30, an upper lateral cartilage 40, and a nasal backbone. (nasal bone, 50) and the like.

The nasal septum cartilage 20 forms a boundary of the left and right nose as a site forming the center of the nose. The nasal septum cartilage 20 has good elasticity and is relatively hard to support the nose back 12 and the nose tip 14 from the inside. The nasal septum cartilage 20 serves as a morphological center to determine the length and height of the nose. Lower cartilaginous region 30, also referred to as alcartilage (alarcartilage) is composed of the lateral cartilage 31 and the medial cartilage 32, as shown in Figure 2, and serves to determine the shape of the nose tip (12). Upper cartilaginous portion 40 constitutes a third 1/3 of the nose and serves to connect the nose bone 50 and the nose (13). Nasal bone (50) is the upper third of the nose consists of a thin thickness.

Referring to FIG. 4, the rain valve 60 serves as a passage inside the nose by flowing airflow as a portion corresponding to the ceiling space at the upper end of the nose. When the non-valve 60 is constricted due to anatomical glandular or acquired abnormalities such as septal curvature, symptoms such as nasal congestion may occur. In order to solve this symptom, it is necessary to improve the structural integrity of the skeleton constituting the non-valve 60. Surgery to expand the nasal septum by reinforcing the nasal passages 16 through the insert is used as one of these improvements.

On the other hand, in the nasal surgery for raising the nose lamp 12, medical silicone or Gore-Tex is generally used as an artificial material inserted into the nose lamp 12 in a long time. In addition, polyethylene terephthalate and proplast are used. I and II (trade name Medpore) may be used. However, these materials may be suitable for raising the nose lamp 12 as a whole as it is inserted into the outside of the nose lamp 12 as a hard material. However, problems such as protrusions and inflammatory reactions can occur inside the nose.

Therefore, such a material is difficult to be applied to applications in which the nose tip 14 is vertically supported by being inserted into the beads 16 in order to alleviate the symptoms of nasal valve stenosis. Due to this problem, in the case of expanding the nasal septum by reinforcing the nasal passage 16, a method of using a relatively hard autologous cartilage is used.

In the surgery to reinforce the nasal passage 16, a portion of the nasal septum cartilage 20 of the patient is cut and processed according to the use, or the costal cartilage is taken from the patient and processed, and then the cartilage is inserted into the nasal passage 16. There is a method to use as a pillar. However, when using autologous cartilage such as septal cartilage or costal cartilage of the patient, autologous cartilage may be infected with the bacteria and deformation or melting may be absorbed, resulting in deformation of the nose shape.

In addition, since the nose end 14 is raised by artificially extending the nasal passage 16 through autologous cartilage at the time of surgery, the force to return to the original low nasal state, ie, downward pressure, acts on the autologous cartilage within the nasal passage 16 after the operation. Done. These autologous cartilage does not have enough rigidity to withstand such downward pressure, so autologous cartilage is liable to bend or damaged after surgery. In addition, a long time after the operation may cause a problem that the autologous cartilage is separated from the original surgical position.

In addition, when transplanting septal cartilage, Asians have a lower nose and lower nasal septum cartilage, which is smaller in size and stiffness than Westerners, which limits the amount of autologous cartilage that can be harvested for transplantation. . The thickness of the nasal septum cartilage is not constant, but if a thin portion is taken and reinforced, the force supporting the nose tip 14 may be weakened. If the thick portion is taken and reinforced, the remaining pillars of the septal cartilage are weakened, which may cause a problem of failing to support the nose and the like (12).

In addition, when the rib cartilage is implanted, a separate operation for collecting the rib cartilage is required, which may involve additional scarring and pain in the body of the patient, and may further increase the overall operation time. Indeed, female patients who primarily do nasal surgery may be reluctant to collect ribs due to scarring around the ribs.

The present invention provides a nasal surgical insert used in place of the autologous cartilage of the patient in performing the nasal surgery to reinforce the nasal cavity 16 for improving the function of the nasal valve 60, etc., to damage the cartilage or other body parts of the patient You can simply perform a nose operation without the need. In addition, the present invention provides a nasal surgical insert that is safe and rigid for bacterial infection instead of autologous cartilage that is vulnerable to bacterial infection and does not have sufficient rigidity, thereby maintaining the shape and function of the nose of the patient after surgery for a long time. .

5 and 6 are views showing the nose surgical insert according to an embodiment of the present invention by way of example. 5 is a plan view of the nose surgical insert 100, Figure 6 is a side view.

Referring to FIG. 5, the nasal surgical insert 100 includes a pillar part 110, a first fixing part 120, and a second fixing part 130. The main body 111 of the pillar portion 110 has a plurality of through holes 112. Similarly, the main bodies 121 and 131 of the first and second fixing parts 120 and 130 also have a plurality of through holes 122 and 132. The first and second fixing parts 120 and 130 may be made of the same material as the pillar part 110, or may be made by shortly cutting the length of the pillar part 110. The horizontal length D of the pillar part 110 and the first and second fixing parts 120 and 130 may be, for example, about 1 cm to 2 cm.

Referring to FIG. 6, the nasal surgical insert 100 has an approximately 'Y' shape upside down as a whole, and the pillar portion 110 and the pillar portion 110, which are positioned in the nose 16 when being inserted into the nose, are long. The first fixing part 120 is connected to one side, and the second fixing part 130 is connected to the other side of the column 110. The pillar portion 110 and the first and second fixing portions 120 and 130 are coupled through the through holes 112, 122, and 132 as shown in FIG. 6 to form one nose surgical insert 100. can do.

The through hole 112 penetrating the body 111 of the pillar part 110, the through hole 122 penetrating the body 121 of the first fixing part 120, and the body of the second fixing part 130. The through hole 132 penetrating the 131 can be easily coupled using a surgical needle and a thread even during surgery by adjusting the penetrating direction. The nose surgical insert 100 may have a total length L determined according to a coupling position of the pillar part 110 and the first and second fixing parts 120 and 130.

In an embodiment, the length L of the nose surgical insert 100 may be, for example, approximately 2 cm to 5 cm. The pillar part 110 and the first and second fixing parts 120 and 130 may have a straight line shape, but are not limited thereto. The pillar part 110 and the first and second fixing parts 120 and 130 may have a shape that follows a curved curve somewhat along the outer surface of the base 16. Can be. The side length d of the pillar part 110 and the first and second fixing parts 120 and 130 may be smaller than the plane length D. The side length d may be approximately 0.5 mm to 3 mm.

The length of the nasal passage 16 (the height of the nose) varies from patient to patient, and the distance between the posterior side 21 and the nasal cartilage 30 of the nasal septum cartilage 20 may also vary from patient to patient. Nose surgical insert 100 according to an embodiment of the present invention by adjusting the coupling position of the pillar portion 100 and the first and second fixing portions 120, 130, the length of the non-note 16 different for each patient and It can respond appropriately to the position of the non-wing cartilage 30.

In addition, the nose surgical insert 100 of the present invention can be tightly adhered to the surrounding tissue by filling the living tissue in the plurality of through holes. To this end, the nasal surgical insert 100 according to an embodiment of the present invention may use a PCL (polycaprolactone) material. PCL materials are highly biocompatible materials.

Figure 7 is a photograph showing a PCL mesh (mesh) used in the nose surgical insert according to an embodiment of the present invention. PCL (polycaprolactone), a biodegradable polymer material, has excellent biocompatible and ton-toxic in the body. The pillar portion 100 and the first and second fixing portions 120 and 130 of the nasal surgical insert 100 may be manufactured using PCL material having structural stability and strong holding force as a living implant.

Nasal surgical insert 100 using the PCL of the present invention may use a gamma sterilized porous PCL mesh. The PCL mesh consists of a fibrous structure about 0.3 mm in diameter and can form a porous interconnect structure with a lay-down pattern of 0/60/120 °. The PCL mesh may have a porosity of 70%. PCL mesh is 0.75mm thick and can be cut to size appropriate for the patient.

PCL is a safe, nontoxic bioabsorbable material that is reabsorbed through normal metabolic pathways by hydrolysis of polymeric ester bonds and is easily excreted. PCL mesh has a porous characteristic, which causes blood and cell contents to be absorbed into the pores through capillary action and thus have a strong resistance to infection. PCL mesh is easy to use as a graft material because of its precise and easy to adjust size and shape, it takes more than two years to disintegrate, retains its strength for a long time and does not remain in the body for a lifetime, thus reducing the risk of potential infection. Can

After surgery, the nasal surgical insert 100 using PCL implanted in the nose can withstand deformation without being forced to return to its original low nasal state, i.e., downward pressure. In addition, the nasal surgical insert 100 using the PCL is not easily deformed or damaged by external impact, so that the shape and function of the nose of the patient may be preserved even after surgery.

8 and 9 are views for explaining the process of the nose surgical insert according to the present invention is inserted into the nose to be combined and fixed with the surrounding tissue. 8 and 9, the first and second fixing parts 120 and 130 may be combined with the rear side 21 of the nasal septum cartilage 20. As shown in FIG. 6, a fixing groove 125 is included between the first fixing part 120 and the second fixing part 130, and the fixing groove 125 has a rear side portion 21 of the nasal septum cartilage 20. ) Can be inserted and positioned.

At the bottom of the nasal septum cartilage 20, an anterior nasal spine (70) composed of hard bones (tibia) is located. The rear side 21 of the nasal septum cartilage 20 is the portion closest to the anterior nasal pole 70 of the nasal septum cartilage 20. On the other hand, the septal cartilage 20 is a wide plate-like cartilage different in thickness or strength depending on the site, the rear side portion 21 of the nasal septum cartilage 20 is a relatively thick and high strength. Since the nasal septum cartilage 20 is a part that is firmly fixed near the tibia frontal electrode 70, when the first fixing part 120 is coupled to the rear side 21 of the nasal septum cartilage 20, the nose Surgical insert 100 may be securely fixed in the nose.

9, the nasal surgical insert 100 includes a suture made of a biodegradable polymer material, a through hole 122 of the first fixing part 120, a rear side 21 of the nasal septum cartilage 20, and 2 through the through hole 132 of the fixing part 130 in order or in the reverse order to suture, it can be fixed to the rear side 21 of the nasal septum cartilage (20). Since the rear side portion 21 of the septal cartilage 20 is cartilage, the surgical needle and the suture can be passed without a separate through-hole forming process. Since the through holes 122 and 132 are already formed in the first and second fixing parts 120 and 130, the first fixing part 120 is attached to the rear side 21 of the nasal septum cartilage using a suture. The process of joining in can be a very simple procedure.

In addition, since the rear side portion 21 of the first fixing portion 120 and the septum cartilage 20 may be overlapped and stitched in multiple layers, it may be more firmly coupled. Here, the suture should be harmless to the human body because it is inserted into the living body, it is possible to select and use a variety of suture known in the art. After a certain period of time, for example about 6 months, the suture is disintegrated and extinguished in the body, and the through-holes 122 and 132 are filled by living tissue, so that the tail of the surrounding tissue, in particular, the septal cartilage 20 It can be integrally bonded with the side portion 21. As a result, the first and second fixing parts 120 and 130 may be stably adhered to and fixed to the rear side 21 of the nasal septum cartilage 20.

On the other hand, the pillar portion 110 may be coupled between the two non-wing cartilage (30a, 30b). As shown in FIG. 9, the nasal surgical insert 100, in which the first and second fixation parts 120 and 130 are coupled to the aft side 21 of the septal cartilage 20 by a suture, is shown in the abdomen 16. It extends long in the roof portion 110 is located between the two non-wing cartilage (30a, 30b). As a result, the pillar portion 110 is located between the inner cartilage (32a 32b) of both non-wing cartilage (30a, 30b).

At this time, the pillar portion 110, the suture made of a biodegradable polymer material to pass through one side of the non-wing cartilage (30a), at least one of the plurality of through holes 112, and the other non-wing cartilage (30b) in turn or in reverse order By suture, it can be fixed between the two non-wing cartilage (30a, 30b). Here, because both sides of the non-wing cartilage (30a, 30b) is cartilage can be passed through the surgical needle and suture without a separate through-hole forming process. Since the plurality of through holes 112 are already formed in the pillar part 110, the process of coupling the pillar part 110 between the two non-wing cartilage 30a and 30b using a suture can be performed in a very simple procedure. have.

On the other hand, since the length of the nasal passage 16 (the height of the nose) varies from patient to patient, the distance between the posterior side 21 and the nasal cartilage 30 of the nasal septum cartilage 20 may also vary. In this regard, since the plurality of through-holes 112 are formed in the horizontal and vertical directions in the pillar portion 110, the plurality of through holes 112 are formed in a plurality of patients in correspondence with the length of the non-adjuvant cartilage 30 and the position of the non-bone cartilage 30 which are different for each patient. The most suitable position of the through hole 112 may be selected and sealed.

As described above, according to the nasal surgical insert 100 for nasal surgery using a PCL according to an embodiment of the present invention, there is no need to collect the septal cartilage or the costal cartilage of the patient used to reinforce the non-adjuvant 16 in the past Therefore, it is possible to prevent the intrinsic function of autologous cartilage is reduced or lost. In addition, the nasal surgical insert 100 according to the present invention does not need to collect the cartilage rib cartilage, so the nasal surgery is simplified, and in addition to the nose, there is no need to additionally cut the skin around the ribs, thus scarring around the ribs of the patient. May not leave.

10 is a view showing the nose surgical insert according to another embodiment of the present invention. The nose surgical insert 200 according to the embodiment of the present invention is the pillar portion 110 is coupled to the first and second fixing parts 220, 230 in one, the nose surgical insert shown in Figure 6 ( 100). Hereinafter, only the configuration with differences will be described, and the rest of the description will be omitted.

Referring to FIG. 10, the nose surgery insert 200 according to an embodiment of the present invention may be formed in one piece by using a PCL material in the pillar portion 210 and the first and second fixing portions 220 and 230. have. The pillar portion 210 and the body 211 of the first and second fixing portions 220 and 230 have a plurality of through holes 212. In FIG. 10, the through hole 212 is shown only at a portion where the pillar 210 and the first and second fixing parts 220 and 230 meet, but the through hole 212 is formed in the horizontal and vertical directions on the entire body. Can be.

As such, the pillar portion 210 and the first and second fixing portions 220 and 230 are formed as a single structure using polycaprolactone (PCL), which is a biodegradable polymer material, thereby inserting a nose surgery 200. The stiffness can be further enhanced and the ability to withstand downward pressure and external shocks to return to the original low nasal state after surgery can be further improved. As a result, even after surgery, the shape and function of the patient's nose can be maintained more stably without damage.

The foregoing is specific embodiments for practicing the present invention. In addition to the above-described embodiments, the present invention will include embodiments that can be simply changed in design or easily changed. In addition, the present invention will also include techniques that can be easily modified and practiced using the embodiments. Therefore, the scope of the present invention should not be limited to the above-described embodiments, but should be determined by the equivalents of the claims of the present invention as well as the following claims.

11: nose root 12: nose
13: Nasal drops 14: Nose tip
15: Nostrils 16: Bijoux (nose pillar)
20: nasal septal cartilage 21: posterior side of nasal septum cartilage
30: non-wing cartilage 31: lateral cartilage
32: medial cartilage 40: upper cartilage area
50: nose bone 60: non-valve
70: tragedy
100, 200: nasal surgical inserts 110, 210: column part
120, 220: first fixing part 130, 230: second fixing part
125: fixing groove 111, 211: body
112, 122, 132, 212: through holes

Claims (6)

A through hole formed of PCL (polycaprolactone) material, the first through holes formed in the body in the horizontal and vertical directions, and the suture made of the biodegradable polymer material in one transverse direction among the non-wing cartilage and the first through holes. Pillar portion is fixed between the two non-wing cartilage of the patient by passing through the field and the other non-wing cartilage in turn or in reverse order;
It is formed of the same PCL material as the pillar portion, the second through holes are formed in the body in the horizontal and vertical direction, the through holes formed in the horizontal direction of the second through holes are the first through holes through the suture A first fixing part coupled to one side of the pillar by being sealed with the through holes formed in a horizontal direction among the pillars; And
The third suture formed of the same PCL material as the pillar portion, the third through holes formed in the body in the horizontal and vertical directions, and the suture passing through the through holes formed in the transverse direction of the first and second through holes, respectively. A second fixing part coupled to the other side of the pillar by being sealed with the through holes formed in the horizontal direction among the through holes,
The rear side portion of the septal cartilage is located in the fixing groove defined between the first and second fixing portions, and the rear side portion has the second and third through holes in the first and second fixing portions. Fixed with sutures passing through the through-holes formed in the horizontal direction,
The total length of the pillar portion and the first and second fixing portions is a through hole formed in the longitudinal direction among the through holes of the pillar portion and the first and second fixing portions in accordance with the height of the nose of the patient and the position of the nasal cartilage. Is determined by the bonding position of,
The pillar portion and the first and second fixing portions are joined by suturing the first through third through holes formed in the transverse direction at the determined engagement position through the suture,
The horizontal length (D) of the column and the first and second fixing portions in the transverse direction is 1 to 2 cm, and the lateral length (d) is 0.5 to 3 mm. delete delete delete The method of claim 1,
The PCL material is a nasal surgical insert consisting of a gamma sterilized porous PCL mesh (PCL mesh). The method of claim 5, wherein
The PCL mesh has a nasal surgical insert having a porous interconnect structure with a lay-down pattern of 0 °, 60 °, and 120 °.

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