Dressing fixation device and method for manufacturing same

Abstract

Disclosed is a dressing fixation device. An embodiment of the present invention provides a dressing fixation device comprising: a cover part formed by mimicking the shape of a body part including an area to be treated; and a support part disposed along an edge of the cover part and having a thickness greater than the thickness of the cover part, wherein the cover part wraps around one side of the body part, in which the area to be treated is positioned, and the other side opposed to the one side and applies pressure to the area to be treated.

Description

Dressing fixation device and method of manufacturing the same

[0001] An embodiment of the present invention relates to a patient-specific dressing fixation device and a method for manufacturing the same.

[0002] Generally, the wound healing process consists of the inflammatory phase (hemostasis, inflammatory response), the proliferative phase (granulation, contraction, epithelialization), and the maturation phase; this serves as a protective mechanism of the body to prevent pathogens and foreign substances from entering the damaged skin area. However, since this wound healing process takes time, dressings are required during this period to protect the incomplete skin barrier and accelerate the healing process. A dressing refers to covering a wound with gauze or similar materials to protect the wound surface, and recently, moist dressings that maintain the wound area in an appropriate moist state are primarily used.

[0003] Conventional wound dressing methods use adhesive tape, glue, gauze, synthetic mesh, etc., to secure the dressing to the wound surface. However, these conventional dressing methods had problems such as causing patient discomfort by requiring excessive dressing to secure it on curved body parts, and the poor fixation of the dressing could hinder normal wound healing or become a risk factor for secondary infection, potentially leading to larger scarring.

[0004] Meanwhile, keloids can also occur as a side effect of the wound healing process. A keloid is a type of hypertrophic scar resulting from the abnormal proliferation of tissue during the healing process following burns, surgical wounds, as well as artificial injuries such as piercings and tattoos. Keloids cause patients not only physical suffering, such as pain and itching, but also psychological distress due to their grotesque appearance. The auricle, in particular, is known to be the site most prone to keloid formation, and because it is a highly visible area compared to other parts of the body, it causes significant cosmetic stress to patients.

[0005] To date, there is no established cure for keloids, and they are generally treated by combining surgical excision with adjuvant therapy. Injection therapy, radiation therapy, and compression therapy are commonly used as adjuvant treatments. Among these, compression therapy involves physically compressing the surgical site and is recommended for a certain period after surgery to suppress abnormal tissue proliferation, minimize scarring, and prevent the recurrence of keloids.

[0006] However, conventional surgical excision treatment compresses the surgical site by fixing the dressing using taping or the like, but there was a problem where the dressing was not properly fixed to the surgical site and fell off due to limitations in the fixing force. In addition, there was a problem where the keloid frequently recurred and treatment was not carried out smoothly because the compression of the surgical site was not properly applied.

[0007] The embodiments of the present invention aim to solve the aforementioned problems or limitations and to provide a dressing fixation device and a method for manufacturing the same that can effectively compress a treatment site by being custom-made for a patient.

[0008] In addition, embodiments of the present invention aim to provide a dressing fixation device that can stably fix a dressing to a wounded treatment site and is easy to attach and detach, as well as a method for manufacturing the same.

[0009] However, these tasks are exemplary and do not limit the scope of the invention.

[0010] One embodiment of the present invention provides a dressing fixing device comprising a cover portion formed by mimicking the shape of a body part including a treatment area, and a support portion disposed along the edge of the cover portion and having a thickness greater than the thickness of the cover portion, wherein the cover portion surrounds one side of the body part where the treatment area is located and the other side opposite to the one side and applies pressure to the treatment area.

[0011] Embodiments of the present invention can be manufactured to be precisely coupled to the patient's body by reflecting not only the curvature of the patient's body part but also the shape of the affected area, thereby allowing the dressing to be stably fixed to the treatment site and the treatment site to be compressed more effectively.

[0012] In addition, the embodiments of the present invention are composed of a shape memory material capable of changing shape according to temperature changes, so that the dressing fixation device can adjust the force compressing the treatment site and deliver uniform and appropriate pressure to prevent keloids from forming on the treatment site.

[0013] In addition, the embodiments of the present invention provide a dressing fixation device that is easy to attach and detach, thereby facilitating the management of the treatment site and the dressing fixation device in the patient's daily life and increasing patient convenience.

[0014] Of course, the scope of the present invention is not limited by these effects.

[0015] FIG. 1 is a flowchart illustrating a method for manufacturing a dressing fixing device according to one embodiment of the present invention.

[0016] FIGS. 2 and FIGS. 3 are diagrams illustrating a method for manufacturing a dressing fixing device according to an embodiment of the present invention.

[0017] FIG. 4 is a perspective view illustrating a dressing fixing device according to one embodiment of the present invention.

[0018] FIG. 5 is a diagram showing the state in which a dressing fixation device according to one embodiment of the present invention is coupled to a treatment site.

[0019] FIG. 6 is a drawing illustrating a dressing fixing device according to another embodiment of the present invention.

[0020] FIG. 7 is a drawing illustrating a dressing fixing device according to another embodiment of the present invention.

[0021] One embodiment of the present invention provides a dressing fixing device comprising a cover portion formed by mimicking the shape of a body part including a treatment area, and a support portion disposed along the edge of the cover portion and having a thickness greater than the thickness of the cover portion, wherein the cover portion surrounds one side of the body part where the treatment area is located and the other side opposite to the one side and applies pressure to the treatment area.

[0022] In one embodiment of the present invention, the cover portion may be spaced apart from the body part, so that a spaced-apart space is formed between them.

[0023] In one embodiment of the present invention, a plurality of through holes may be formed in the cover portion.

[0024] In one embodiment of the present invention, the cover portion is divided into a plurality of regions, and a plurality of through holes having different diameters may be formed for each of the divided regions.

[0025] In one embodiment of the present invention, the cover portion and the support portion may be made of a material capable of changing shape according to temperature changes.

[0026] In one embodiment of the present invention, the cover portion and the support portion have ductility when heated to a first critical temperature range and their shape is deformed through pressure, and can self-restore to their original shape when heated to a second critical temperature range.

[0027] In one embodiment of the present invention, the cover portion and the support portion may include a shape memory material.

[0028] In one embodiment of the present invention, a ring-shaped ring portion extending from the support portion may be further included.

[0029] In one embodiment of the present invention, the thickness of the ring portion may be the same as the thickness of the support portion.

[0030] Another embodiment of the present invention provides a method for manufacturing a dressing fixation device comprising the steps of: obtaining a scan image of a body part including a treatment area of ​​a patient through 3D scanning; generating a corrective image of a body part to be fitted with a dressing fixation device using the obtained scan image; generating a blueprint of the dressing fixation device using the generated corrective image; and manufacturing the dressing fixation device based on the generated blueprint. The dressing fixation device comprises a cover portion formed by mimicking the shape of the body part including the treatment area, and a support portion disposed along the edge of the cover portion and having a thickness greater than the thickness of the cover portion. The cover portion surrounds one side of the body part where the treatment area is located and the other side opposite to the one side, and applies pressure to the treatment area.

[0031] In another embodiment of the present invention, the body part includes an ear, and the step of generating the correction image may involve using a scan image of the normal side ear included in the scan image to remove a keloid lesion from the ear to be worn with the dressing fixation device and generating the correction image.

[0032] In another embodiment of the present invention, the step of generating the design drawing may be designed so that the cover part is spaced apart from the body part by a predetermined distance.

[0033] In another embodiment of the present invention, a plurality of through holes may be formed in the cover portion.

[0034] In another embodiment of the present invention, the cover portion is divided into a plurality of regions, and the through hole having a different diameter may be formed for each of the divided regions.

[0035] In another embodiment of the present invention, the cover portion and the support portion may be made of a material capable of changing shape according to temperature changes.

[0036] In another embodiment of the present invention, the cover portion and the support portion have ductility when heated to a first critical temperature range and their shape is deformed through pressure, and can self-restore to their original shape when heated to a second critical temperature range.

[0037] In another embodiment of the present invention, the cover portion and the support portion may include a shape memory material.

[0038] In another embodiment of the present invention, a ring-shaped ring portion extending from the support portion may be further included.

[0039] In another embodiment of the present invention, the thickness of the ring portion may be the same as the thickness of the support portion.

[0040] Other aspects, features, and advantages other than those described above will become clear from the following drawings, claims, and detailed description of the invention.

[0041] Hereinafter, the following embodiments will be described in detail with reference to the attached drawings. When describing with reference to the drawings, identical or corresponding components are given the same reference numerals, and redundant descriptions thereof will be omitted.

[0042] Since the embodiments are capable of various modifications, specific embodiments are illustrated in the drawings and described in detail in the detailed description. The effects and features of the embodiments and the methods for achieving them will become clear by referring to the details described below in conjunction with the drawings. However, the embodiments are not limited to those disclosed below and can be implemented in various forms.

[0043] In the drawings, parts unrelated to the explanation have been omitted to clearly explain the invention, and similar parts throughout the specification have been given similar reference numerals.

[0044] In the following embodiments, terms such as first, second, etc. are used not in a limiting sense, but for the purpose of distinguishing one component from another.

[0045] In the following embodiments, singular expressions include plural expressions unless the context clearly indicates otherwise.

[0046] In the following examples, terms such as "include" or "have" mean that the features or components described in the specification are present, and do not preclude the possibility that one or more other features or components may be added.

[0047] Where an embodiment can be implemented differently, the order of specific steps may be performed differently from the order described. For example, two steps described consecutively may be performed substantially simultaneously or proceed in the reverse order of the description.

[0048] FIG. 1 is a flowchart illustrating a method for manufacturing a dressing fixing device (100) according to one embodiment of the present invention, and FIG. 2 and FIG. 3 are state diagrams illustrating a method for manufacturing a dressing fixing device (100) according to one embodiment of the present invention.

[0049] Referring to FIGS. 1 to 3, a method for manufacturing a dressing fixing device (100) according to one embodiment of the present invention may include the steps of acquiring a scanned image (S100), generating a correction image using the scanned image (S200), generating a design drawing for the dressing fixing device (100) using the correction image (S300), and manufacturing the dressing fixing device (100) based on the design drawing (S400).

[0050] As illustrated in FIGS. 1 and 2, a manufacturing device for a dressing fixation device (100) (hereinafter, manufacturing device) first scans a body part including a patient's treatment area and obtains a scan image of the patient's body part (S100).

[0051] Here, the treatment area refers to an area within a specific part of the patient's body that requires fixation with a dressing or requires compression therapy. For example, the treatment area may include a skin lesion area requiring surgical excision. Specifically, the treatment area may correspond to a surgical site for the removal of a malignant tumor or a benign skin tumor that has occurred on a specific part of the body, a surgical site for the removal of a keloid lesion (C), or an affected area where a scar has formed due to a keloid lesion (C), and may be set larger than the actual surgical site or the affected area to account for a margin of error. As another example, the treatment area may include various wound areas other than surgical wounds, such as lacerations, abrasions, ulcers, burns, etc.

[0052] The dressing fixing device (100) can be attached to a body part having a different three-dimensional shape for each patient, such as the ear, nose, or finger, to fix a dressing to a treatment site where a wound, such as a surgical wound, has occurred, or to compress a treatment site where a wound has occurred or a treatment site where a keloid scar has occurred. For convenience of explanation, the technical concept of the present invention is described below with a dressing fixing device (100) attached to the patient's ear for the treatment of a keloid lesion (C) that has occurred on the patient's ear, and a method of manufacturing the same; however, the present invention is not limited thereto, and it is understood that modifications are possible so that it can be attached to a wound site where a dressing needs to be fixed or to various body parts that require compression treatment.

[0053] In one embodiment, the scan image may include three-dimensional (3D) information regarding the shape of each of the patient's two ears. Specifically, the scan image may include a first scan image (10) containing 3D information regarding the shape of the ear (E1) on which the dressing fixation device (100) is worn, and a second scan image (20) containing 3D information regarding the shape of the normal ear (E2).

[0054] Here, the ear (E1) on which the dressing fixation device (100) is worn refers to the ear containing the treatment area where the keloid lesion (C) occurred among the patient's two ears, and the normal side ear (E2) refers to the ear opposite to the ear containing the treatment area.

[0055] The scan image may include information regarding the location where the keloid lesion (C) occurred in the patient's ear and the shape of the keloid lesion (C). Additionally, the scan image may include information regarding the location and shape of the treatment area, including the keloid lesion (C) and the periphery of the keloid lesion (C). Here, the treatment area may refer to the area where the dressing fixation device (100) is attached and fixed in the ear (E1) where the dressing fixation device (100) is worn.

[0056] In another embodiment, the scan image may be obtained by photographing only the body part where the keloid lesion (C) has occurred. That is, the scan image may consist only of the first scan image (10) containing 3D information about the shape of the ear (E1) on which the dressing fixation device (100) is worn. When applying compression treatment without surgical treatment for a keloid lesion (C) that has occurred on a specific body part, 3D information of the body part for designing the dressing fixation device (100) attached to the body part can be obtained by photographing the patient's body part containing the keloid lesion (C) and obtaining a scan image. In this case, the step (S200) of generating a correction image described later may be omitted.

[0057] Meanwhile, FIG. 2 illustrates an example in which a scan image is generated by 3D scanning both ears of a patient with a 3D scanner (S), but the present invention is not limited thereto. As another example, the scan image of both ears of a patient may be obtained by receiving image data captured by medical imaging equipment such as magnetic resonance imaging (MRI) or computed tomography (CT) from the manufacturing device.

[0058] Next, the manufacturing device uses the first scan image (10) and the second scan image (20) to generate a correction image (30) for the ear (E1) on which the dressing fixing device (100) is worn (S200).

[0059] Here, the correction image (30) is an image of the ear (E1) on which the dressing fixation device (100) is worn, and may be an image in which the keloid lesion (C) has been removed. The manufacturing device may synthesize a first scan image (10) containing 3D information about the shape of the ear (E1) on which the dressing fixation device (100) is worn, and a second scan image (20) containing 3D information about the shape of the normal side ear (E2), and generate the correction image (30).

[0060] In one embodiment, the manufacturing device may generate a corrected image (30) by symmetrically shifting a second scan image (20) of the normal ear (E2) with respect to a virtual line, superimposing the symmetric image of the normal ear (E2) generated through the symmetrical shift onto a first scan image (10) of the ear (E1) to which the dressing fixing device (100) will be worn, and removing a keloid lesion (C) from the first scan image (10) using the superimposed symmetric image.

[0061] That is, the correction image (30) can be generated by aligning the second scan image (20) of the normal side ear (E2) with the first scan image (10) of the ear (E1) where the dressing fixation device (100) is worn, and by removing the keloid lesion (C) to match the shape of the normal side ear (E2).

[0062] Next, the manufacturing device generates a design drawing (40) for a dressing fixing device (100) using the generated calibration image (30) and / or the first scan image (10) (S300).

[0063] The manufacturing device can generate a design drawing (40) for the dressing fixing device (100) by 3D modeling the dressing fixing device (100) in three dimensions according to a preset program based on the generated calibration image (30) and / or the first scan image (10).

[0064] Specifically, the manufacturing device can design the shape of the dressing fixation device (100) by simulating the shape of a body part including the treatment area based on a correction image (30) or a first scan image (10). Additionally, the manufacturing device can design the dressing fixation device (100) and generate a design drawing (40) based on information about a keloid lesion (C) or information about the treatment area included in the correction image (30) and / or the first scan image (10), so that the dressing fixation device (100) can be fixed to the treatment area while compressing the treatment area with a predetermined pressure.

[0065] That is, the dressing fixing device (100) may be designed to have a shape suitable for fixing the dressing fixing device (100) on the treatment site by taking into account the location and shape of the treatment site, and to compress the treatment site with appropriate pressure by maintaining a predetermined distance from the treatment site.

[0066] For example, the dressing fixing device (100) may be designed to extend from one side of the ear (E1) containing the treatment area to the other side opposite to said one side to wrap around the earlobe included in the treatment area, and may be designed to have a curved portion formed along the curvature of the ear (E1). Here, one side of the ear refers to the front side of the ear visible when looking at the patient's face from the front, and the other side of the ear may refer to the back side of the ear.

[0067] In one embodiment, the dressing fixing device (100) may be designed to form a predetermined spacing between the ear (E1) on which the dressing fixing device (100) is worn and the dressing fixing device (100) so that a dressing can be placed therein. For example, the dressing fixing device (100) may be designed to form a predetermined spacing between the front of the ear and the dressing fixing device (100) and / or between the back of the ear and the dressing fixing device (100) as it is spaced a predetermined distance from the ear (E1).

[0068] Immediately after keloid removal surgery, a dressing is applied to the surgical site to aid in the recovery of the surgical wound. Accordingly, the manufacturing device is designed so that the dressing fixing device (100) surrounds the treatment site at a predetermined distance from the ear (E1), thereby allowing the dressing to be placed in the gap formed between the dressing fixing device (100) and the ear, and the dressing fixing device (100) can surround and fix the dressing placed on the treatment site, and ensure that the dressing adheres closely to the treatment site.

[0069] In another embodiment, the manufacturing device may design the shape of the dressing fixing device (100) by simulating the shape of a body part including the treatment area based on the first scan image (10), and in this case, the design drawing (40) of the dressing fixing device (100) may be designed so that no gap occurs between the ear (E1) on which the dressing fixing device (100) is worn and the dressing fixing device (100). After the wound from keloid removal surgery has healed, there is no need to attach a dressing to the surgical site, but it is necessary to compress the surgical site to prevent the recurrence of the keloid. In addition, for a treatment area where compression treatment is applied without performing keloid removal surgery, it is necessary for the dressing fixing device (100) to compress the treatment area without a dressing. Accordingly, the manufacturing device may design the dressing fixing device (100) so that the entire surface area of ​​the dressing fixing device (100) is in close contact with the ear (E1) and can compress the treatment area.

[0070] Additionally, in one embodiment, the manufacturing device may divide the treatment area of ​​the ear (E1) to which the dressing fixing device (100) is attached into a plurality of regions, and design the dressing fixing device (100) to compress the ear (E1) with different forces for each divided region. The force with which the dressing fixing device (100) compresses the ear (E1) may vary depending on the distance between the dressing fixing devices (100) positioned facing each other on the front and back sides of the ear (E1).

[0071] That is, in the divided areas of the ear (E1), the shorter the distance between the first area of ​​the dressing fixing device (100) positioned on the front of the ear (E1) and the second area of ​​the dressing fixing device (100) positioned on the back of the ear (E1), the more strongly the dressing fixing device (100) presses against the ear (E1). Accordingly, the manufacturing device can be designed so that the distance between the first area and the second area positioned opposite each other with the ear (E1) in between is different for each divided area of ​​the ear (E1), and the force pressing against the ear (E1) is different.

[0072] For example, the manufacturing device can divide the treatment area of ​​the ear (E1) to which the dressing fixation device (100) is attached into multiple areas based on the location of the keloid lesion (C) and the distance from the keloid lesion (C), and the dressing fixation device (100) can be designed to compress the ear (E1) with a stronger force the closer the area is to the keloid lesion (C).

[0073] Next, the manufacturing device manufactures a dressing fixing device (100) based on the generated design (40) (S400).

[0074] The manufacturing device can manufacture a dressing fixing device (100) based on a design drawing (40) of a dressing fixing device (100) that is modeled in three dimensions. For example, the manufacturing device can manufacture a dressing fixing device (100) by printing the dressing fixing device (100) by stacking it within the three-dimensional space of a 3D printer device using the material of the dressing fixing device (100). However, the present invention is not limited thereto, and any method capable of manufacturing the dressing fixing device (100) according to the design drawing (40) of the dressing fixing device (100), such as injection molding, can be applied to the manufacturing of the dressing fixing device (100).

[0075] In one embodiment, the manufacturing device may print a dressing fixing device (100) using a stereolithography apparatus (SLA)-based 3D printer. Since the process of the manufacturing device 3D printing the dressing fixing device (100) is similar to a commonly used 3D printing process, a detailed description thereof will be omitted.

[0076] The material of the dressing fixation device (100) may be made of a material having sufficient hardness to apply pressure to the treatment site. Additionally, the material of the dressing fixation device (100) may be a material capable of changing shape according to temperature changes.

[0077] In one embodiment, the material of the dressing fixing device (100) may include a shape memory material. As a specific example, the material of the dressing fixing device (100) may be a shape memory polymer (SMP), but is not limited thereto. Here, a shape memory polymer (SMP) can be understood as a polymer having the property of returning to its original shape when brought back to a certain condition (temperature, pressure, etc.), even if its shape changes due to external conditions (temperature, pressure, etc.) after being manufactured to have a certain shape under specific conditions.

[0078] For example, when the dressing fixing device (100) is heated to a first critical temperature range, it becomes ductile and can be deformed by applying pressure, and can be hardened by cooling in the deformed shape. Additionally, when the dressing fixing device (100) is heated to a second critical temperature range, it becomes ductile again and can self-restore to its original shape. Here, the first critical temperature range may be higher than the second critical temperature range, and the second critical temperature range may be lower than the first critical temperature range and higher than body temperature. For example, the first critical temperature range may be a temperature range of about 60°C to about 70°C, and the second critical temperature range may be a temperature range of about 39°C to about 59°C.

[0079] That is, the user can apply force to the dressing fixing device (100) while the dressing fixing device (100) is heated to a first critical temperature range higher than a second critical temperature range, thereby causing the dressing fixing device (100) to unfold. The dressing fixing device (100) can be slowly cooled at room temperature while maintaining the unfolded state.

[0080] Additionally, the user can place the unfolded dressing fixing device (100) on the treatment site of the ear (E1) and apply heat to the dressing fixing device (100) at a second critical temperature range to self-restore the dressing fixing device (100) to its original shape. The dressing fixing device (100) that has self-restored to its original shape can be coupled to the treatment site of the ear (E1) to fix the dressing on the treatment site or to compress the treatment site with a predetermined pressure.

[0081] FIG. 4 is a perspective view illustrating a dressing fixing device (100) according to one embodiment of the present invention, and FIG. 5 is a state diagram illustrating a state in which a dressing fixing device (100) according to one embodiment of the present invention is coupled to a treatment site.

[0082] Referring to FIGS. 4 and 5, a dressing fixation device (100) according to one embodiment of the present invention may be coupled to a treatment area of ​​the ear (E1) and compress the treatment area with a predetermined pressure. Here, the treatment area is an area requiring fixation of the dressing or compression treatment, and may include a surgical portion where a keloid lesion (C) has been removed and a surrounding portion surrounding said surgical portion. Additionally, the treatment area may include a keloid scar portion that has not undergone surgical treatment.

[0083] In this embodiment, the dressing fixation device (100) is manufactured as a customized dressing fixation device (100) for fixing a dressing to the ear (E1) and applying a predetermined pressure after an excision surgery to remove a keloid lesion (C) that has occurred on the ear (E1), but is not limited thereto and can, of course, be used for keloid lesions (C) on other body parts other than the ear (E1). At this time, the shape of the dressing fixation device (100) may be manufactured in a form that can apply a predetermined pressure to the treatment area, including the surgical site where the keloid lesion (C) has been removed or the treatment area including the keloid scar.

[0084] In one embodiment, the dressing fixing device (100) may include a cover portion (110) and a support portion (120). The cover portion (110) may be positioned to cover one side of a body part where the treatment area is located and the other side opposite to said one side. Here, said one side and the other side of the body part may refer to two surfaces facing each other with the treatment area in between (e.g., the front and back of the ear).

[0085] Specifically, when the dressing fixation device (100) is used to fix the dressing after surgery to remove a keloid lesion (C), the cover portion (110) may be provided to cover the surgical site where the keloid lesion (C) has been removed, along with the dressing, and the surrounding area surrounding the surgical site. As another example, when the dressing fixation device (100) is used to compress the treatment site without a dressing, the cover portion (110) may be provided to cover the treatment site in close contact with the treatment site. An embodiment in which the cover portion (110) is in close contact with the treatment site will be described in detail later with reference to FIG. 6.

[0086] For example, if the treatment area is near the auricle on the front side of the ear (E1), the cover portion (110) may have a shape that extends from the front side of the ear (E1) to the back side of the ear (E1). Accordingly, the cover portion (110) may compress the treatment area by having a first area positioned on the front side of the ear (E1) and a second area positioned on the back side of the ear (E1) positioned opposite each other with the treatment area in between.

[0087] In one embodiment, the cover portion (110) may have a uniform thickness overall. For example, the cover portion (110) may have a thickness of 0.5 mm to 5 mm. However, the thickness of the cover portion (110) may vary depending on the characteristics and design of the material of the cover portion (110), so it is not limited thereto.

[0088] In another embodiment, the cover portion (110) may be provided to have different thicknesses for each region corresponding to a plurality of regions divided in the treatment area. By having the cover portion (110) have different thicknesses for each of the plurality of divided regions, the pressure applied by the cover portion (110) to each region of the treatment area can be configured differently, and a more suitable pressure can be provided to the treatment area.

[0089] The cover portion (110) may be made of a material having sufficient hardness to apply pressure to the treatment area. Additionally, the cover portion (110) may be composed of a material capable of changing shape according to temperature changes. The cover portion (110) may unfold as needed or be bent to have a curvature corresponding to the patient's ear (E1).

[0090] That is, the cover portion (110) can be made flexible under temperature and pressure conditions and can be spread out to a shape close to a flat plate, and at room temperature it self-restores to its original shape and hardens, thereby allowing the treatment area to be compressed with appropriate pressure.

[0091] Additionally, the cover portion (110) may be made of a material having characteristics such as transparency or biocompatibility. If the cover portion (110) is made of a transparent material, it may be easy to observe the treatment site during the patient's treatment. Furthermore, since the dressing fixation device (100) is a device that comes into direct contact with the patient's body, the cover portion (110) constituting a part thereof is required to be biocompatible.

[0092] A plurality of through holes (111) may be formed in the cover portion (110) to ensure airflow. In one embodiment, the through holes (111) may be formed throughout the entire cover portion (110). In this case, the through holes (111) formed throughout the entire cover portion (110) may all have the same diameter, but are not limited thereto.

[0093] For example, the through hole (111) formed in the cover portion (110) may be formed by dividing the cover portion (110) into multiple regions, with each region having a different diameter. Specifically, the through hole (111) may have a different size in the region corresponding to the surgical site where the keloid lesion (C) was removed and in other regions of the cover portion (110). If the through hole (111) formed in the region corresponding to the surgical site in the cover portion (110) is made smaller than the through hole (111) formed in other regions, the surgical site can be compressed more strongly.

[0094] As another example, the through hole (111) may be formed such that its diameter varies according to the curvature of the cover portion (110). Specifically, the durability of the cover portion (110) can be improved by having the through hole (111) have a relatively small diameter in the part where the curvature is relatively large and the through hole (111) have a relatively large diameter in the part where the curvature is relatively small. In addition, as the diameter of the through hole (111) varies according to the curvature of the cover portion (110), the entire treatment area of ​​the ear (E1) can be compressed with appropriate pressure regardless of the curvature of the cover portion (110).

[0095] In another embodiment, the through hole (111) may be formed only in a part of the cover portion (110). For example, the through hole (111) may be formed only in the remaining part of the cover portion (110), excluding the part corresponding to the surgical site where the keloid lesion (C) was removed. In this case, the part of the cover portion (110) where the through hole (111) is not formed may compress the ear (E1) more strongly than the part where the through hole (111) is formed.

[0096] Meanwhile, in one embodiment, the cover portion (110) may have a shape that covers the ear (E1) while being spaced apart from the ear (E1) by a predetermined distance. That is, the cover portion (110) may be provided in a shape that can cover the treatment area by mimicking the curvature of the ear (E1) at a position spaced apart from the ear (E1) by a predetermined distance.

[0097] Specifically, the cover portion (110) may have a shape that surrounds the earlobe and covers a part of the front surface of the ear (E1) and a part of the back surface of the ear (E1), and a first spaced-out space (g1) may be formed between the front surface of the ear (E1) and a second spaced-out space (g2) may be formed between the back surface of the ear (E1). At this time, the distance at which the cover portion (110) is spaced from the front surface and the back surface of the ear (E1), respectively, may have a value selected from the range of 0.5 to 4 times the thickness of the cover portion (110).

[0098] A dressing may be placed in the first separation space (g1) and the second separation space (g2). The cover portion (110) covers the dressing attached to the treatment area of ​​the ear (E1), can fix the dressing to the treatment area, and can compress the treatment area so that the dressing adheres to the front surface of the ear (E1) and the back surface of the ear (E1).

[0099] The support member (120) is connected to the cover member (110) and can be positioned along the perimeter of the cover member (110). The support member (120) can be formed integrally with the cover member (110). A first region of the support member (120) can be fixed on the front surface of the ear (E1), and a second region of the support member (120) can be fixed on the rear surface of the ear (E2).

[0100] The support portion (120) may have a thicker thickness than the cover portion (110). By having the support portion (120) have a thicker thickness than the cover portion (110), the connection between the dressing fixing device (100) and the ear (E1) can be made more secure, and the dressing fixing device (100) can stably fix the dressing placed in the first spaced space (g1) and the second spaced space (g2).

[0101] The support portion (120) may be made of the same material as the cover portion (110) (e.g., shape memory polymer (SMP)). In this embodiment, the cover portion (110) and the support portion (120) are composed of a shape memory material, but are not limited thereto, and various types of materials capable of changing shape according to temperature changes may be used for the cover portion (110) and the support portion (120).

[0102] In one embodiment, a dressing fixing device (100) composed of a cover portion (110) and a support portion (120) becomes pliable when heated in a first critical temperature range (a temperature range of about 60°C to about 70°C) and can be hardened by being spread out through pressure. Then, the dressing fixing device (100) becomes pliable again when heated in a second critical temperature range (a temperature range of about 39°C to about 59°C) and can self-restore to its original shape.

[0103] For example, the dressing fixation device (100) can be unfolded by pressure at a certain temperature range (e.g., about 65°C) and then hardened so as to be attached to the ear (E1). After the unfolded and hardened dressing fixation device (100) is placed on the treatment site of the ear (E1), it can self-restore to its original shape to wrap around and compress the treatment site of the ear (E1) as it is heated to a certain temperature range (e.g., 55°C).

[0104] In addition, the dressing fixing device (100) attached to the ear (E1) can be heated to a certain temperature range (e.g., about 65°C) and then unfolded by pressure in order to be separated from the ear (E1). In this way, the dressing fixing device (100) can change shape according to temperature changes, allowing the user to easily wear it on the ear (E1) or separate it from the ear (E1), and the dressing fixing device (100), which has hardened after being attached to the ear (E1), can be stably fixed to the treatment area of ​​the ear (E1).

[0105] In addition, since the dressing fixation device (100) is custom-made using a scanned image of the patient's ear (E1), it causes less discomfort when worn and allows the treatment site to be compressed with optimized pressure. Furthermore, since the custom-made dressing fixation device (100) is securely attached to the patient's ear (E1), the patient can wear it comfortably and perform daily activities.

[0106] FIG. 6 is a drawing illustrating a dressing fixing device (100) according to another embodiment of the present invention.

[0107] Compared to the dressing fixing device (100) according to the embodiment described in FIG. 4 and 5, the dressing fixing device (100) according to the embodiment shown in FIG. 6 differs in that no gap is formed between it and the ear (E1). Therefore, the following description will focus on the differences mentioned above, and redundant descriptions will be omitted.

[0108] Referring to FIG. 6, a dressing fixing device (100) according to another embodiment of the present invention can be manufactured so that no gap occurs between it and the ear (E1).

[0109] Specifically, the manufacturing device can generate a design drawing (40) of a dressing fixing device (100) to precisely implement the shape of the ear (E1) based on a scanned image of the ear (E1). Through this, the dressing fixing device (100) produced can be completely in close contact with the ear (E1) without any separation, and pressure can be transmitted more effectively to the treatment site of the ear (E1).

[0110] Accordingly, the dressing fixation device (100) can be fixed to the treatment site where a scar remains due to the keloid lesion (C) and can properly compress the treatment site, thereby effectively preventing the keloid from recurring.

[0111] At this time, it is important for the dressing fixing device (100), which is fixed in close contact with the ear (E1) without a dressing, to ensure breathability and appropriately adjust the pressure compressing the ear (E1). If the pressure compressing the ear (E1) is too weak, a keloid may recur, and if the pressure compressing the ear (E1) is too strong, a pressure ulcer wound may occur. Accordingly, the dressing fixing device (100) can ensure breathability and adjust the amount of pressure compressing the ear (E1) by forming a through hole (111) in the cover portion (110) and adjusting the area where the through hole (111) is formed and the diameter of the through hole (111) as needed.

[0112] In one embodiment, the dressing fixing device (100) may form a concave portion (110a) that is recessed inward from the shape of the ear (E1) in a cover portion (110) corresponding to a part of the treatment area that requires greater pressure than the surrounding area. The concave portion (110a) can apply pressure to a certain area of ​​the ear (E1) with greater pressure than the surrounding area.

[0113] In addition, as another example, the dressing fixing device (100) may divide the cover portion (110) into multiple regions and form the cover portion (110) to have different thicknesses for each divided region, so that the pressure exerted by the cover portion (110) on the treatment area of ​​the ear (E1) is different for each region.

[0114] In this way, the dressing fixing device (100) can be configured so that the pressure applied to the ear (E1) is configured differently for each area, thereby maximizing the therapeutic effect through compression. However, the present invention is not limited thereto, and the dressing fixing device (100) may be configured to apply uniform pressure to the entire treatment area.

[0115] FIG. 7 is a drawing illustrating a dressing fixing device (100') according to another embodiment of the present invention.

[0116] Compared to the dressing fixing device (100) according to the embodiment described in FIG. 4 and 5, the dressing fixing device (100') according to the embodiment illustrated in FIG. 7 differs in that it further includes a loop portion (130') extending from the support portion (120). Therefore, the following description will focus on the differences mentioned above, and redundant descriptions will be omitted.

[0117] Referring to FIG. 7, a dressing fixing device (100') according to another embodiment of the present invention may further include a loop portion (130').

[0118] The ring portion (130') may be provided in the shape of a ring extending from the support portion (120). Specifically, the ring portion (130') may extend from the support portion (120) positioned on the front of the ear (E1), wrap around a part of the ear (E1), and then be connected to the support portion (120) positioned on the back of the ear (E1).

[0119] As illustrated in FIG. 7(a), the ring portion (130') has a curved shape along the curvature of the ear (E1) and can be positioned adjacent to the area where the earlobe begins. That is, the ring portion (130') can be attached to the ear (E1) by extending in a direction different from the curved direction in which the cover portion (110) and the support portion (120) are attached to the ear (E1), and can serve to prevent the cover portion (110) and the support portion (120) from detaching from the ear (E1).

[0120] The ring portion (130') may be made of the same material as the cover portion (110) and the support portion (120) (e.g., shape memory polymer (SMP)). That is, the ring portion (130') may have flexibility within a certain temperature range, making it easy to attach and detach.

[0121] Additionally, the ring portion (130') may have the same thickness as the support portion (120), but is not limited thereto. As another example, the ring portion (130') may have a thicker thickness than the cover portion (110) and a thinner thickness than the support portion (120).

[0122] Meanwhile, as illustrated in FIG. 7(b), the loop portion (130') may be provided in multiple numbers. The multiple loop portions (130') may extend in different directions and be connected to the ear (E1). For example, the dressing fixing device (100') may include two loop portions (130'), and the two loop portions (130') may extend in opposite directions relative to the cover portion (110) and the support portion (120) to support the cover portion (110) and the support portion (120).

[0123] Specifically, one of the two loop portions (130') can be extended upward on the ear (E1) and attached to the earlobe, and the other of the two loop portions (130') can be extended downward on the ear (E1) and attached to the earlobe. The dressing fixing device (100') can be provided with a plurality of loop portions (130') so that the cover portion (110) and the support portion (120) can be attached to the ear (E1) more stably.

[0124] As described above, embodiments of the present invention provide a dressing fixation device (100) manufactured to be customized for the patient, thereby enabling the stable fixation of a dressing to a treatment site where a surgical wound or the like has occurred, and preventing the formation of keloids in the treatment site by appropriately compressing the treatment site. In addition, as it is manufactured to be customized for the patient, wearability is improved and bonding strength is enhanced, and it is possible to ensure that there are no restrictions on the patient's daily activities. Furthermore, it can be manufactured quickly to fit various shapes of body parts that differ from patient to patient, and can provide an optimized compression treatment effect for the patient.

[0125] The embodiments may also be implemented in the form of a recording medium containing computer-executable instructions, such as program modules executed by a computer. A computer-readable medium may be any available medium accessible by a computer and includes both volatile and non-volatile media, and both removable and inremovable media. Additionally, a computer-readable medium may include both computer storage media and communication media. A computer storage medium includes both volatile and non-volatile, removable and inremovable media implemented by any method or technique for storing information, such as computer-readable instructions, data structures, program modules, or other data. A communication medium typically includes computer-readable instructions, data structures, other data of modulated data signals such as program modules, or other transmission mechanisms, and includes any information transmission medium.

[0126] Additionally, in this specification, "part" may be a hardware component, such as a processor or circuit, and / or a software component executed by a hardware component, such as a processor.

[0127] As such, the present invention has been described with reference to an embodiment illustrated in the drawings, but this is merely illustrative, and those skilled in the art will understand that various modifications and variations of the embodiments are possible therefrom. Accordingly, the true technical scope of protection of the present invention should be determined by the technical spirit of the appended claims.

[0128] The present invention relates to a dressing fixation device and a method for manufacturing the same, and can be used as a medical aid for fixing a dressing and compression therapy on a treatment site.

Claims

1. A cover portion formed by mimicking the shape of a body part including a treatment area; and A support member disposed along the edge of the cover portion and having a thickness greater than the thickness of the cover portion; comprising A dressing fixing device in which the above-mentioned cover portion surrounds one side of the body part where the treatment area is located and the other side opposite to the one side, and applies pressure to the treatment area.

2. In Paragraph 1, A dressing fixing device in which the above-mentioned cover portion is spaced apart from the above-mentioned body part, forming a spaced-apart space between them.

3. In Paragraph 1, A dressing fixing device having a plurality of through holes formed in the above-mentioned cover portion.

4. In Paragraph 3, A dressing fixing device in which the above-mentioned cover portion is divided into a plurality of regions, and a plurality of through holes having different diameters are formed for each of the divided regions.

5. In Paragraph 1, A dressing fixing device in which the above cover portion and the above support portion are made of a material capable of changing shape according to temperature changes.

6. In Paragraph 5, A dressing fixing device in which the cover portion and the support portion become ductile when heated to a first critical temperature range and their shape is deformed through pressure, and self-restore to their original shape when heated to a second critical temperature range.

7. In Paragraph 1, A dressing fixing device comprising the above cover portion and the above support portion, wherein the above cover portion and the above support portion comprise a shape memory material.

8. In Paragraph 1, A dressing fixing device further comprising a ring-shaped loop portion extending from the above support portion.

9. In Paragraph 8, A dressing fixing device in which the thickness of the above-mentioned ring portion is the same as the thickness of the above-mentioned support portion.

10. A step of acquiring a scan image of a body part including the patient's treatment area through 3D scanning; A step of generating a correction image of the body part to be worn with the dressing fixation device using the acquired scanned image; A step of generating a design drawing for the dressing fixation device using the generated correction image; and The method includes the step of manufacturing the dressing fixing device based on the generated design drawing; and The above dressing fixing device is, A cover portion formed by mimicking the shape of the body part including the treatment area; and A support member disposed along the edge of the cover portion and having a thickness greater than the thickness of the cover portion; comprising A method for manufacturing a dressing fixation device, wherein the above-mentioned cover portion surrounds one side of the body part where the treatment area is located and the other side opposite to the one side, and applies pressure to the treatment area.

11. In Paragraph 10, The above body part includes the ear, and A method for manufacturing a dressing fixation device, wherein the step of generating the correction image above involves removing a keloid lesion from the ear to be worn by using a scan image of the normal side ear included in the scan image above and generating the correction image above.

12. In Paragraph 10, A method for manufacturing a dressing fixation device, wherein the step of generating the above design drawing is designed so that the cover portion is spaced apart from the body part by a predetermined distance.

13. In Paragraph 10, A method for manufacturing a dressing fixing device in which a plurality of through holes are formed in the above-mentioned cover portion.

14. In Paragraph 13, A method for manufacturing a dressing fixing device, wherein the above-described cover portion is divided into a plurality of regions, and the through holes having different diameters are formed for each of the divided regions.

15. In Paragraph 10, A method for manufacturing a dressing fixing device, wherein the cover portion and the support portion are made of a material capable of changing shape according to temperature changes.

16. In Paragraph 15, A method for manufacturing a dressing fixing device, wherein the cover portion and the support portion become ductile when heated to a first critical temperature range and their shape is deformed through pressure, and self-restore to their original shape when heated to a second critical temperature range.

17. In Paragraph 10, A method for manufacturing a dressing fixing device, wherein the cover portion and the support portion comprise a shape memory material.

18. In Paragraph 10, A method for manufacturing a dressing fixing device, further comprising a ring-shaped ring portion extending from the above-mentioned support portion.

19. In Paragraph 18, A method for manufacturing a dressing fixing device, wherein the thickness of the above-mentioned ring portion is the same as the thickness of the above-mentioned support portion.

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