Polymer scaffold for prosthesis and manufacturing method thereof
Patent Information
- Application Number
- KR1020260133282
- Authority / Receiving Office
- KR · KR
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2026-07-20
- Publication Date
- 2026-08-14
Smart Images
Figure PAT00003_ABST
Abstract
Description
Technology Field
[0001] The present invention relates to a prosthetic polymer scaffold made of a biodegradable polymer material for the stabilization and regeneration of a wound, inserted into a wound to support the wound, and a method for manufacturing the same. Background Technology
[0002] Conventionally, even when a space is created due to tissue damage or rupture in the surgical site, such as within a muscle or joint, the surgery is typically completed by wrapping the ligaments and tissues with sutures.
[0003] For example, in the case of rotator cuff repair surgery illustrated in Fig. 1, the surgery is performed by making an incision in part and inserting an arthroscope to view a monitor screen, rather than directly observing the inside of the joint.
[0004] As a result, the distance between the end of the surgical instrument and the hand is long, and since the surgical instrument must be controlled indirectly through a monitor, unless the surgeon is extremely skilled, a long surgery of more than one hour must be performed after administering general anesthesia.
[0005] In addition, consistent rehabilitation exercises must be performed within a set period after surgery to allow the regenerable tissue at the surgical site to recover and the sutures to stabilize.
[0006] However, since there is an empty space in the surgical site and the muscles have not recovered, movements for rehabilitation cause significant pain, so the rehabilitation process is inevitably a continuous series of tremendous suffering.
[0007] To solve this problem, a technology has been developed that facilitates the rehabilitation process by inserting a tube-shaped device into the surgical site as described in US Patent 9,770,337 B2, and filling the inside of the tube with liquid through a special nozzle during the surgery to protect the surgical site, while also significantly reducing pain by minimizing movement of the surgical site during the rehabilitation process.
[0008] However, in the prior art, since leakage of the liquid filled in the tube must be prevented, the nozzle that injects the liquid into the tube must be equipped with precision mechanisms of a special structure at its end so that no nozzle insertion hole remains in the tube after it is removed from the tube.
[0009] In addition, to prevent liquid leakage, the tube must be prevented from dissolving inside the body, which requires a separate removal surgery to take the tube out later, resulting in slower patient recovery and high costs.
[0010] In addition, while conventional technology can perform the function of repairing ligament tissue by attaching biodegradable polymers such as collagen to the ligament during a ligament repair procedure, conventional technology has the problem that the strength of the biodegradable hydrogel scaffold alone is weak, it is difficult to fix collagen, etc. to the target tissue surface in the body, and collagen, etc. easily becomes disorganized in the body after the procedure.
[0011] Therefore, there is a need for a technology that can eliminate costs and stress by maintaining the stabilization of the surgical site and pain reduction effects of conventional technology, while eliminating the need for subsequent removal surgery.
[0012] In particular, since recovery and tissue regeneration rates vary depending on the type of affected area or the patient's age, there is a need to control the drug delivery rate; however, technology for biodegradable prosthetic polymer scaffolds capable of controlling biodegradation rates and tissue support properties is still difficult to find.
[0013] Furthermore, despite the fact that the type and size of the affected area vary depending on the type and severity of the injury, and that even for similar injuries, the speed of recovery and tissue regeneration can differ based on the patient's age, body type, and physique, the technology for implantable prosthetics that can be customized for patients is still lacking. Prior art literature
[0014] U.S. Patent No. 9,770,337 (Date of Registration: September 26, 2017) The problem to be solved
[0015] Accordingly, since the type and size of the affected area vary depending on the type and severity of the injury, and even for similar injuries, the speed of recovery and tissue regeneration may vary depending on the patient's age, body type, and physique, the present invention aims to provide a prosthetic polymer scaffold, which is an insertable support that can be customized for the patient, and a method for manufacturing the same.
[0016] In addition, by controlling electrospinning conditions to realize external sheets with different porosities and densities, we aim to provide a prosthetic polymer scaffold having biodegradable properties corresponding to the patient's treatment period and tissue regeneration characteristics. means of solving the problem
[0017] A prosthetic polymer scaffold according to the present invention for achieving such purposes comprises two outer sheets formed with a certain size and shape and made of a biodegradable synthetic polymer material, and an inner sheet disposed between the two outer sheets and made of a biodegradable natural polymer material, wherein the edges of the two outer sheets are joined together to form a sealed pouch, the outer sheets are formed by cutting a portion of a synthetic polymer matrix having a larger area and thickness than the outer sheets and made of the biodegradable synthetic polymer material, and the inner sheet is formed by cutting a portion of a natural polymer matrix having a larger area and thickness than the inner sheet and made of the biodegradable natural polymer material.
[0018] Here, the edges of the two outer sheets are preferably joined by heat pressing, so that the edges can be formed into a heat-bonded band of a certain width.
[0019] In addition, the plurality of synthetic polymer matrices can preferably be formed into a fine network structure by spraying a synthetic polymer solution through a piston nozzle and applying a high voltage to the piston nozzle so that the sprayed synthetic polymer forms into a fine fiber strand, and the fine fiber strands are amorphously stacked on a collector plate. At this time, a plurality of synthetic polymer matrices having different porosities and densities can be formed by controlling at least one of the viscosity of the synthetic polymer solution filled into the piston nozzle, the magnitude of the high voltage, the inflow rate of the synthetic polymer solution flowing into the piston nozzle, or the amount of salt added to the synthetic polymer solution, and the two outer sheets can be cut from each of the plurality of synthetic polymer matrices to have different porosities and densities.
[0020] And the material of the above synthetic polymer matrix may preferably include a component composed of one or more combinations of PLA [poly(L-lactic acid], PLGA [poly(glycolic acid)], PCL [poly(ε-Caprolactone)], and PLCL [poly(l-lactide-co-ε-capprolactone)].
[0021] In addition, the material of the above natural polymer matrix may preferably include a component consisting of one or more combinations of collagen type 1, HA (sodium hyaluronate), and chondroitin sulfate.
[0022] And the inner sheet may preferably contain a therapeutic agent for the regeneration of affected tissue.
[0023] Meanwhile, the method for manufacturing a polymer scaffold according to the present invention comprises the steps of: mixing a biodegradable natural polymer fuel to make a natural polymer solution, and then drying the natural polymer solution to produce a natural polymer matrix; mixing a biodegradable synthetic polymer fuel to make a synthetic polymer solution, and then producing a synthetic polymer matrix using the synthetic polymer solution; cutting out an inner sheet from the natural polymer matrix to an area and thickness corresponding to the affected area to be injected; cutting out two outer sheets from the synthetic polymer matrix twice to a certain area and thickness so as to have an area larger than the inner sheet; placing the inner sheet between the two outer sheets; and joining the two outer sheets along the edges.
[0024] Here, the step of producing the synthetic polymer matrix can preferably be carried out by spraying and dispersing the synthetic polymer solution through a piston nozzle, and by placing a high-pressure electrode at the nozzle and applying a high voltage, the surface tension of the synthetic polymer sprayed from the nozzle is weakened so that it forms into a fine fiber strand shape, and the fiber strands are sequentially amorphously stacked on a collector plate of a predetermined area in which the fiber shape is prepared.
[0025] In this case, the step of producing the synthetic polymer matrix can preferably control the porosity and density of the completed synthetic polymer matrix by increasing or decreasing the viscosity of the synthetic polymer solution to make the thickness of the fiber strands smaller or larger, increasing or decreasing the magnitude of the high voltage to make the thickness of the fiber strands smaller or larger, and decreasing or increasing the inflow speed of the synthetic polymer solution flowing into the piston nozzle to make the thickness of the fiber strands smaller or larger.
[0026] In addition, the step of preparing the synthetic polymer matrix can further reduce the diameter of the fiber strands spun from the piston nozzle by preferably adding a salt to the synthetic polymer solution to increase the charge density of the surface of the synthetic polymer sprayed from the piston nozzle.
[0027] Meanwhile, the step of joining along the edges is preferably composed of the step of bringing the edges of the two outer sheets into close contact with each other and the step of joining by applying heat along the area where the edges of the outer sheets are in close contact, so that even if the outer sheet and the inner sheet are manufactured to have an area corresponding to the size and shape of a specific wound, they can be manufactured in the form of a sealed pouch that can be quickly inserted into the wound. Effects of the invention
[0028] The prosthetic polymer scaffold and the method for manufacturing the same according to the present invention have the effect of being able to be provided to a patient in a customized manner, as the type and size of the affected area vary depending on the type and severity of the injury, and even for similar injuries, the speed of recovery and tissue regeneration may vary depending on the patient's age, body type, and physique.
[0029] Furthermore, since external sheets with different porosities and densities can be produced under electrospinning conditions, biodegradable properties corresponding to the patient's tissue regeneration rate and treatment duration can be achieved, and stable tissue support is possible while reducing pressure applied to the affected area as the external sheet gradually dissolves. Brief explanation of the drawing
[0030] FIGS. 1a and 1b are drawings showing conventional rotator cuff repair surgery, FIG. 2 is a perspective view of a prosthetic polymer scaffold according to the present invention. FIG. 3 is a side cross-sectional view of FIG. 2, FIG. 4 is a plan view of FIG. 2, FIG. 5 is a conceptual diagram showing electron emission in the method for manufacturing a prosthetic polymer scaffold according to the present invention. FIG. 6 is a conceptual diagram showing some principles of the electron radiation of FIG. 5. FIG. 7 is a conceptual diagram showing the later process of the method for manufacturing a prosthetic polymer scaffold according to the present invention. FIG. 8 is a flowchart illustrating a method for manufacturing a prosthetic polymer scaffold according to the present invention. Specific details for implementing the invention
[0031] The specific structural or functional descriptions presented in the embodiments of the present invention are merely illustrative for the purpose of explaining embodiments according to the concept of the present invention, and embodiments according to the concept of the present invention may be implemented in various forms. Furthermore, it should not be interpreted as being limited to the embodiments described herein, but should be understood to include all modifications, equivalents, and substitutions that fall within the spirit and scope of the present invention.
[0032] The present invention will be described in detail below with reference to the attached drawings.
[0033] As shown in FIGS. 2 to 4, the prosthetic polymer scaffold (10) according to the present invention is formed with a certain size and shape and consists of two outer sheets (200) made of a biodegradable synthetic polymer material and an inner sheet (100) disposed between the two outer sheets (200) and made of a biodegradable natural polymer material.
[0034] Here, two outer sheets (200) are formed into a sealed pouch shape by joining their edges together, and the outer sheet (200) is made of a biodegradable synthetic polymer material and is formed by cutting a portion of a synthetic polymer matrix (8) that has a larger area and thickness than the outer sheet (200), and the inner sheet (100) is made of a biodegradable natural polymer material and can be formed by cutting a portion of a natural polymer matrix (7) that has a larger area and thickness than the inner sheet (100).
[0035] That is, the outer sheet (200), which is a biodegradable synthetic polymer, and the inner sheet (100), which is a biodegradable natural polymer, are first manufactured in the form of a relatively large volume matrix having a certain size and thickness. Then, when a patient requiring immediate insertion arises, the prosthesis is cut into a size and shape corresponding to the actual patient requiring it, according to the size of the space where the prosthesis must be inserted in the affected area, the severity of the injury, and the recovery period according to the patient's age, thereby allowing the insertable prosthesis to be prepared immediately in a customized manner.
[0036] At this time, the two outer sheets (200) are joined at the edges to form a sealed pouch, thereby preventing the inner sheet (100) from dissolving rapidly when body fluid seeps in and allowing it to decompose at a constant speed as it passes through the microstructure forming the outer sheet (200).
[0037] In particular, the inner sheet (100) dissolves in body fluid and passes through the microstructure forming the outer sheet (200), and can pass through the outer sheet (200) together with the therapeutic medicine contained in the inner sheet (100). Here, the speed at which the therapeutic medicine also exits to the outside can be controlled according to the characteristics of the microstructure of the outer sheet (200), so that the therapeutic medicine can be supplied to the affected area at a speed suitable for the characteristics of the patient and the characteristics of the affected area.
[0038] Meanwhile, even when the inner sheet does not contain therapeutic medicine, the inner sheet gradually dissolves due to body fluids, and the dissolution rate is controlled by the microstructure of the outer sheet, allowing for stable support of the affected area.
[0039] Additionally, the synthetic polymer matrix (8) corresponding to the raw material of the outer sheet (200) may have a tissue structure in the form of a network structure in which fine strands of nanofibers (9) are amorphously stacked. In this case, the fine strands of nanofibers (9) may be extracted in the form of electrospinning, which will be described later.
[0040] In this way, when the outer sheet (200) is manufactured by electrospinning and has a structure in which fine nanofibers (9) are amorphously stacked, multiple synthetic polymer matrices (8) with different porosity and densities can be formed by controlling the viscosity of the synthetic polymer solution filled into the piston nozzle, the magnitude of the applied high voltage, the inflow rate of the synthetic polymer solution into the piston nozzle, or the amount of salt added to the synthetic polymer solution, and the two outer sheets (200) cut from these can be configured to have biodegradable properties corresponding to the characteristics of the affected area, the age of the patient, the tissue regeneration rate, and the treatment period. In addition, since the outer sheet (200) gradually dissolves while stably maintaining the dissolution of the inner sheet (100) after being inserted into the body, the prosthetic polymer scaffold (10) according to the present invention can shrink at an appropriate speed without applying unnecessary pressure to the affected area according to the degree of recovery of the affected area, thereby stably supporting the affected area. In an embodiment where a therapeutic drug is included in the inner sheet (100), the release rate of the therapeutic drug can also be controlled by the fine mesh structure of the outer sheet (200).
[0041] At this time, the edges of the two outer sheets (200) can be joined by heat pressure to form a heat-bonded band (210) of a certain width. That is, although the outer sheets (200) can be formed by cutting them immediately to any size, if heat is applied and joined along the edges for a certain width, the edges can be formed directly into a heat-bonded band (210) and become a sealed pouch.
[0042] Therefore, the formation of the heat bonding band (210) means that the prosthetic polymer scaffold (10) according to the present invention can be immediately manufactured into a customized prosthesis that fits a specific actual patient, and this effect is achieved by having the heat bonding band (210) provided and not requiring any other separate configuration for sealing.
[0043] And, as the outer sheet (200) is made of a material in which fine nanofibers (9) are laminated as described above, the density and porosity of the outer sheet (200) can be controlled, so that the synthetic polymer matrix (8) can be formed into a fine mesh structure by irregularly laminating synthetic polymer nanofibers (9) that are injected by applying high voltage to the piston nozzle (1).
[0044] At this time, depending on the viscosity of the synthetic polymer solution filled in the piston nozzle (1) and the magnitude of the high voltage, the thickness of the nanofibers (9) and the stacking distance between the nanofibers (9) are formed differently, thereby providing a plurality of synthetic polymer matrices (8) with different densities and porosities, so that the outer sheet (200) can be provided with a plurality of outer sheets (200) with different densities and porosities.
[0045] For reference, the material of the synthetic polymer matrix (8) here may include a component composed of one or more combinations of PLA [poly(L-lactic acid], PLGA [poly(glycolic acid)], PCL [poly(ε-Caprolactone)], and PLCL [poly(l-lactide-co-ε-caprolactone)].
[0046] And the material of the natural polymer matrix (7) may include a component consisting of one or more combinations of collagen type 1, HA (sodium hyaluronate), and chondroitin sulfate.
[0047] Hereinafter, a method for manufacturing a polymer scaffold for prosthetics according to the present invention will be described.
[0048] The prosthetic polymer scaffold according to the present invention comprises the steps of: preparing a natural polymer matrix (7) by mixing a biodegradable natural polymer fuel to make a natural polymer solution and then drying the natural polymer solution; preparing a synthetic polymer matrix (8) by mixing a biodegradable synthetic polymer fuel to make a synthetic polymer solution and then preparing the synthetic polymer solution; preparing an inner sheet (100) by cutting out an area and thickness corresponding to the affected area to be injected from the natural polymer matrix (7); preparing two outer sheets (200) by cutting out a certain area and thickness twice from the synthetic polymer matrix (8) so that they have an area larger than the inner sheet (100); placing the inner sheet (100) between the two outer sheets (200); and joining the two outer sheets (200) along the edges.
[0049] At this time, as described above, the outer sheet (200) can be manufactured in a customized size by producing it in the form of a synthetic polymer matrix (8) and then cutting it, and the porosity and density can be controlled by producing the synthetic polymer matrix using an electrospinning method.
[0050] Accordingly, the step of producing the synthetic polymer matrix (8) can be carried out by an electrospinning method in which a synthetic polymer solution is sprayed and dispersed through a piston nozzle (1) as shown in FIG. 5, and a high voltage is applied by placing a high-pressure electrode (2) on the piston nozzle (1) so that the surface tension of the synthetic polymer sprayed from the piston nozzle (1) is weakened, forming a fine nanofiber (9) strand shape, and the fiber strands are sequentially amorphously stacked on a collector plate (3) of a certain area in which the fiber shape is prepared in advance.
[0051] At this time, the step of producing the synthetic polymer matrix (8) can control the porosity and density of the completed synthetic polymer matrix (8) by increasing or decreasing the viscosity of the synthetic polymer solution to make the thickness of the fiber strands smaller or larger, increasing or decreasing the magnitude of the high voltage to make the thickness of the fiber strands smaller or larger, and decreasing or increasing the flow rate of the synthetic polymer solution flowing into the piston nozzle (1) to make the thickness of the fiber strands smaller or larger.
[0052] At this time, as shown in FIG. 5, charges are injected into the discharged polymer solution to charge it, and the opposite electrode is grounded to the collector plate (3). When the polymer solution forms a hemispherical shape due to the surface tension of the polymer discharged from the nozzle tip, the liquid polymer solution droplet is stretched into a cone-like funnel shape due to the mutual electrostatic repulsion between surface charges caused by the high voltage and the Coulomb force applied to the external electric field, as shown in FIG. 6. Here, as charges continue to accumulate in the polymer solution, spin-stretching occurs into a Taylor cone-shaped jet due to the mutual repulsion of the same charges, as shown on the right side of FIG. 5. At this time, fibers are gathered in the direction of the collector plate (3) that is charged with the opposite charge or grounded.
[0053] In this case, the diameter of the nanofibers produced by electrospinning depends significantly on the spinning conditions.
[0054] The first factor in spinning conditions is voltage. Higher voltage can increase the diameter of nanofibers by introducing a larger amount of polymer solution into the jet, whereas in the case of natural polymer materials such as silk, the diameter of the nanofibers may decrease as the voltage increases. In particular, high surface charge density induces high ion mobility, leading to strong electrostatic repulsion, which causes significant elongation and further reduces the diameter of the nanofibers.
[0055] The second factor is the viscosity of the polymer solution. In electrospinning, for solutions with low viscosity, the polymer accumulates in droplet form due to surface tension. As the concentration gradually increases, the droplets do not collapse but fly through the air, forming a stable continuous fiber through a process in which spindle-shaped droplets are connected to each other by fine threads. Additionally, as the viscosity of the solution increases, the degree of entanglement of polymer chains within the solvent increases, hindering the collapse of the jet (cone jet, liquid jet, or initial jet), so the jet takes on a fibrous shape.
[0056] When the speed at which the polymer solution flows into the piston nozzle is controlled so that the flow rate becomes faster, the droplet size formed at the end of the nozzle increases, and the solvent does not completely evaporate even when it reaches the collector plate (3) after spinning, so the final nanofiber (9) layer may include a bead shape or a structure in which multiple strands of fibers intersect.
[0057] Therefore, as the flow rate of the polymer solution decreases, the diameter of the nanofiber (9) obtained decreases, and as the flow rate of the polymer solution increases, the diameter of the nanofiber (9) obtained also increases.
[0058] In addition, the step of preparing the synthetic polymer matrix (8) can further reduce the diameter of the nanofiber (9) strands ejected from the piston nozzle (1) by adding a small amount of salt to the synthetic polymer solution to increase the charge density on the surface of the synthetic polymer sprayed from the piston nozzle (1). This is because the added salt induces the formation of a higher charge density on the surface of the polymer solution being discharged. As a result, the mobility of the polymer solution increases, and a large electrostatic repulsion is generated, causing significant elongation.
[0059] Accordingly, according to the method for manufacturing a prosthetic polymer scaffold (10) according to the present invention, the porosity and density of the outer sheet can be controlled so that an optimal prosthesis can be provided to the affected area of a specific patient, and a plurality of synthetic polymer matrices and natural polymer matrices with different porosities and densities are provided, thereby enabling the provision of a prosthesis in which the dissolution rate can be controlled to be optimized for the patient's treatment period and tissue regeneration period.
[0060] The present invention described above is not limited by the aforementioned embodiments and attached drawings, and it will be obvious to those skilled in the art that various substitutions, modifications, and changes are possible within the scope of the technical concept of the present invention. Explanation of the symbols
[0061] TC: Taylor cone shape 1: Piston nozzle 2: High-voltage electrode 3: Collector plate 7: Natural polymer matrix 8: Synthetic polymer matrix 9 : Nanofiber 10 : Prosthetic polymer scaffold according to the present invention 100 : Inner seat 200 : Outer seat 210 : Thermal bonding band
Claims
Claim 1 Two outer sheets formed with a fixed size and shape and made of a biodegradable synthetic polymer material; It includes an inner sheet made of a biodegradable natural polymer material disposed between the two outer sheets; wherein the edges of the two outer sheets are joined by heat pressure along the areas in close contact with each other, so that the edges are formed into a heat-bonded band of a certain width, thereby forming a sealed pouch shape; wherein the two outer sheets are formed into a pouch with four sides sealed by heat-bonding their corresponding four edge surfaces; wherein the two outer sheets are formed by cutting a portion of each from a plurality of synthetic polymer matrices made of the biodegradable synthetic polymer material, having a larger area and thickness than each outer sheet, and having different porosity and density; wherein the inner sheet is formed by cutting a portion of a natural polymer matrix made of the biodegradable natural polymer material, having a larger area and thickness than the inner sheet; wherein the plurality of synthetic polymer matrices are each dispersed by spraying a synthetic polymer solution through a piston nozzle, and a high voltage is applied by placing a high-pressure electrode on the piston nozzle so that the surface tension of the synthetic polymer sprayed from the piston nozzle is weakened, thereby forming a fine fiber strand shape; and A prosthetic polymer scaffold having a network structure formed by the amorphous lamination of microfibers, wherein the outer sheet is formed by the amorphous lamination of microfibers by sequentially amorphously laminating fine fiber strands onto a pre-prepared collector plate of a certain area to form the plurality of synthetic polymer matrices, wherein the synthetic polymer material is composed of any one of polylactic acid (PLA), polylactic-co-glycolic acid (PLGA), polycaprolactone (PCL), and polylactic-co-caprolactone (PLCL), the natural polymer material is composed of collagen type 1, and the plurality of synthetic polymer matrices control the viscosity of the synthetic polymer solution or control the magnitude of the high voltage,A prosthetic polymer scaffold characterized by being formed to have different porosities and densities by controlling the diameter of the fiber strands spun by at least one of the methods of controlling the inflow rate of the synthetic polymer solution flowing into the piston nozzle or increasing the surface charge density by adding a salt to the synthetic polymer solution, wherein after the prosthetic polymer scaffold is inserted into the body, the inner sheet is formed to dissolve by body fluids, and the outer sheet is configured to gradually dissolve within the body to reduce pressure applied to the affected area. Claim 2 The method comprises the steps of: preparing a natural polymer matrix by mixing biodegradable natural polymer raw materials to form a natural polymer solution and then drying the natural polymer solution; preparing a plurality of synthetic polymer matrices having different porosities and densities by mixing biodegradable synthetic polymer raw materials to form a synthetic polymer solution and then preparing the plurality of synthetic polymer matrices using the synthetic polymer solution; preparing an inner sheet by cutting out an area and thickness corresponding to the affected area to be injected from the natural polymer matrix; preparing two outer sheets by cutting out a certain area and thickness from each of the plurality of synthetic polymer matrices so that they each have an area larger than the inner sheet; placing the inner sheet between the two outer sheets; and joining the two outer sheets along the edges; wherein the step of preparing the plurality of synthetic polymer matrices comprises, for each of the plurality of synthetic polymer matrices, spraying and dispersing the synthetic polymer solution through a piston nozzle, wherein a high-voltage electrode is placed on the piston nozzle and a high voltage is applied so that the surface tension of the synthetic polymer sprayed from the piston nozzle is weakened and formed into a fine fiber strand, and the fine fiber strand is formed into a predetermined certain A method for manufacturing a prosthetic polymer scaffold, wherein the plurality of synthetic polymer matrices are formed by sequentially amorphously stacking them on a collector plate of an area, and the step of bonding along the edges comprises the step of pressing the edges of the two outer sheets together and the step of bonding by applying heat along the area where the edges of the outer sheets are pressed together, wherein the four edge surfaces of the two outer sheets are each heat-bonded to form a pouch shape with four sides sealed, and wherein the outer sheet and the inner sheet are manufactured to have an area corresponding to the size and shape of a specific affected area, wherein the synthetic polymer material is polylactic acid (PLA), polylactic-co-glycolic acid (PLGA),A method for manufacturing a prosthetic polymer scaffold, characterized in that the polymer is composed of either polycaprolactone (PCL) or polylactic-co-caprolactone (PLCL), the natural polymer material is composed of collagen type 1, the step of producing the plurality of synthetic polymer matrices is performed such that the porosity and density of the plurality of synthetic polymer matrices are controlled differently from each other by controlling the diameter of the fiber strands spun through at least one of the following methods: controlling the viscosity of the synthetic polymer solution, controlling the magnitude of the applied high voltage, controlling the inflow rate of the synthetic polymer solution flowing into the piston nozzle, or increasing the surface charge density by adding a salt to the synthetic polymer solution, and the two outer sheets are each produced by cutting from the plurality of synthetic polymer matrices formed to have different porosities and densities, and after the prosthetic polymer scaffold is inserted into the body, the inner sheet dissolves due to body fluids and the outer sheet gradually dissolves within the body to reduce pressure applied to the affected area.