Shapeable medical film

Abstract

The present invention discloses a plastic medical membrane. In particular, it refers to a biodegradable plastic medical membrane, which can be applied to dentistry or other disciplines. The plastic medical membrane includes a dense layer and a porous layer, and the porous layer is arranged on the dense layer. The dense layer is formed by a first material, and the porous layer is formed by a second material. The plastic medical membrane has a plastic temperature range. The melting point of the dense layer is within the plastic temperature range, and the melting point of the porous layer is higher than the plastic temperature range.

Description

Technical Field

[0001] The invention relates to a plastic medical film, in particular to a biodegradable plastic medical film. Background Art

[0002] Before dental implant surgery, guided bone regeneration (GBR), commonly known as bone filling surgery, is usually performed to solve the problem of alveolar bone atrophy caused by long-term tooth loss in the implant area.

[0003] See also Figure 1 As shown in the figure, during the guided bone regeneration procedure, the gum G is first turned over, and bone powder B is placed in the bone defect to promote the proliferation of bones in the tooth ridge R. In order to prevent the gum G, oral mucosa and other soft tissues from occupying the growth space of the bone during cell proliferation, an isolation membrane F is covered on the bone powder B to isolate the alveolar bone from the soft tissue, and finally the gum G is sutured. In this way, the growth of bone cells in a specific space can be controlled to achieve the purpose of reconstructing the tooth ridge R.

[0004] The isolation membrane commonly used in the industry is made of collagen (hereinafter referred to as collagen membrane). The physical properties of collagen are weak, and it is easy to break after dental implantation, which causes the artificial bone to fall off. In addition, the collagen membrane does not have the function of shaping. In order to completely cover the wound, the doctor needs to fix the shape of the collagen membrane through sutures or other auxiliary methods. Therefore, the collagen membrane has the problems of weak physical properties and inconvenience in use.

[0005] Therefore, how to improve the existing isolation membrane to enhance the physical properties of the isolation membrane and increase the convenience of use to overcome the above-mentioned defects has become one of the important issues that this industry wants to solve. Summary of the invention

[0006] The technical problem to be solved by the present invention is to provide a plastic medical membrane in view of the deficiencies of the prior art.

[0007] In order to solve the above technical problems, one of the technical solutions adopted by the present invention is to provide a plastic medical membrane. The plastic medical membrane includes a dense layer and a porous layer. The dense layer is formed by a first material. The porous layer is arranged on the dense layer, and the porous layer is formed by a second material. The plastic medical membrane has a plastic temperature range, the melting point of the dense layer is within the plastic temperature range, and the melting point of the porous layer is higher than the plastic temperature range.

[0008] Furthermore, when the plastic medical membrane is at a temperature within the plastic temperature range, the dense layer is in a plastic state, and the shape of the porous layer changes with the shape of the dense layer.

[0009] Furthermore, the shaping temperature ranges from 45°C to 100°C.

[0010] Furthermore, the melting point of the first material is lower than 100°C, and the melting point of the second material is not lower than 100°C.

[0011] Furthermore, the melting point of the first material is between 45°C and 70°C, and the melting point of the second material is between 100°C and 150°C.

[0012] Furthermore, the viscosity of the first material is 0.20 dl / g to 1.87 dl / g.

[0013] Furthermore, the viscosity of the second material is 2.00 dl / g to 6.50 dl / g.

[0014] Furthermore, the porous layer has a porous structure, and a portion of the dense layer is disposed in the porous structure.

[0015] Furthermore, the thickness of the plastic medical film is 200 microns to 600 microns.

[0016] Furthermore, the thickness of the dense layer is 150 micrometers to 300 micrometers.

[0017] Furthermore, the porous layer has a thickness of 50 micrometers to 400 micrometers.

[0018] Furthermore, the first material includes polycaprolactone, and the second material includes polylactic acid.

[0019] Furthermore, the weight average molecular weight of the first material is 5000 g / mol to 50000 g / mol.

[0020] Furthermore, the tensile stress of the moldable medical membrane after being immersed in a physiological saline solution at 37° C. for 30 minutes is greater than 10 MPa.

[0021] Furthermore, the tensile stress of the plastic medical film is greater than 10 MPa at a temperature of 25° C. and an absolute humidity of 50%.

[0022] Furthermore, the suture retention strength of the plastic medical film according to the ISO 7198 test standard is above 10N.

[0023] One of the beneficial effects of the present invention is that the plastic medical membrane provided by the present invention can achieve the effect of improving the physical properties of the plastic medical membrane and making the plastic medical membrane have plastic properties through the technical solution of "the melting point of the dense layer is within the plastic temperature range, and the melting point of the porous layer is higher than the plastic temperature range".

[0024] To further understand the features and technical contents of the present invention, please refer to the following detailed description and drawings of the present invention. However, the drawings provided are only for reference and description and are not intended to limit the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 Schematic diagram illustrating guided bone regeneration.

[0026] Figure 2 It is a schematic side cross-sectional view of the plastic medical membrane of the present invention. DETAILED DESCRIPTION

[0027] The following is to illustrate the embodiments of the "plastic medical membrane" disclosed in the present invention through specific examples. Those skilled in the art can understand the advantages and effects of the present invention from the contents disclosed in this specification. The present invention can be implemented or applied through other different specific embodiments, and the details in this specification can also be modified and changed based on different viewpoints and applications without departing from the concept of the present invention. In addition, the drawings of the present invention are only simple schematic illustrations, not depictions based on actual sizes, and are stated in advance. The following embodiments will further describe the relevant technical contents of the present invention in detail, but the disclosed contents are not intended to limit the scope of protection of the present invention. In addition, the term "or" used herein may include any one or more combinations of the associated listed items depending on the actual situation.

[0028] The plastic medical membrane of the present invention can be applied to guided bone regeneration surgery and used as an isolation membrane to separate bone powder and soft tissue. Since the plastic medical membrane has good physical properties, the problem of easy rupture of the isolation membrane during dental implantation can be improved. In addition, the plastic medical membrane of the present invention has a plastic function. By appropriately changing the temperature, the shape of the plastic medical membrane can be changed so as to fit more closely to the injured part. Therefore, the plastic medical membrane of the present invention has better convenience of use.

[0029] The plastic medical film is not limited to dental surgery, but can be used in any surgery related to the human body. However, in order to maintain the coherence of the description and fully express the characteristics of this case, the application of dental surgery will be mainly described in this specification.

[0030] The plastic medical film of the present invention has a plastic temperature range, and when the temperature of the plastic medical film is within the plastic temperature range, the shape of the plastic medical film can be changed. Specifically, the plastic temperature range can be 45°C to 100°C, but it should be noted that any temperature range within the range of 45°C to 100°C belongs to the plastic temperature range referred to in the present invention. In other words, the upper limit and lower limit of the plastic temperature range can be any integer between 45°C and 100°C, such as but not limited to: 45°C, 50°C, 55°C, 60°C, 65°C, 70°C, 75°C, 80°C, 85°C, 90°C, 95°C or 100°C.

[0031] When the moldable medical membrane of the present invention is used as an isolation membrane, the moldable medical membrane can be placed in deionized water at 45°C to 100°C, or a heating plate at 45°C to 100°C can be used for shaping, so that the shape of the moldable medical membrane corresponds to the shape of the alveolar bone. After cooling, the moldable medical membrane is reshaped, and the molded moldable medical membrane can be placed on the alveolar bone and bone powder to completely cover the bone powder and achieve the effect of isolating the bone powder from the soft tissue. In this way, the effect of guided bone regeneration can be improved.

[0032] See also Figure 2 As shown, the plastic medical membrane of the present invention comprises a dense layer 10 and a porous layer 20 , wherein the porous layer 20 is disposed on the dense layer 10 .

[0033] The dense layer 10 has good physical strength and can improve the physical properties of the entire plastic medical membrane. Since the dense layer 10 has no pores, it can effectively isolate epithelial cells and bone cells to prevent epithelial cells from occupying the growth space of bone cells after proliferation. In addition, the dense layer 10 has a plastic property, and the melting point of the dense layer 10 is within the plastic temperature range. Therefore, at a temperature within the plastic temperature range, the dense layer 10 is in a plastic state, and the shape of the dense layer 10 can be reshaped.

[0034] The density of the porous layer 20 is less than that of the dense layer 10. The porous layer 20 has a porous structure and is flexible. In some embodiments, a portion of the dense layer 10 is formed in the porous structure, so that the dense layer 10 and the porous layer 20 have good bonding force. When in use, the porous layer 20 contacts the alveolar bone, so that the periodontal tissue can grow by adhering to the porous structure of the porous layer 20, promoting the regeneration and repair of the alveolar bone. In addition, the melting point of the porous layer 20 is higher than the shaping temperature range. Therefore, at a temperature in the shaping temperature range, the porous layer 20 itself is not in a plastic state, but can achieve the function of supporting the dense layer 10. In addition, since the porous layer 20 is flexible, the shape of the porous layer 20 will change with the shape of the dense layer 10, thereby making the plastic medical membrane have plastic characteristics and good physical strength.

[0035] The dense layer 10 is formed of a first material, and the porous layer 20 is formed of a second material, and the first material is different from the second material. By selecting different materials, the plastic medical membrane has good physical properties at room temperature, and at the molding temperature (45°C to 100°C), the plastic medical membrane has the property of being plastic.

[0036] Specifically, the melting point of the first material is lower than 100° C., and the melting point of the second material is higher than 100° C. Furthermore, the melting point of the first material is 45° C. to 70° C., and the melting point of the second material is 100° C. to 150° C. It can be seen that the dense layer 10 contributes to the plasticity of the plastic medical film.

[0037] At a temperature within the shaping temperature range, the dense layer 10 is in a plastic state, and the shape of the overall plastic medical membrane can be adjusted. Since the melting point of the porous layer 20 is higher than the shaping temperature range, the porous layer 20 can maintain its original shape during the shaping process to achieve the effect of supporting the dense layer 10. Moreover, the shape of the porous layer 20 will change with the shape of the dense layer 10, and a deformation stress will be stored due to the deformation. In addition, the original porous structure of the porous layer 20 will not be destroyed by temperature changes, so that the porous layer 20 still has a bendable property.

[0038] When the temperature of the plastic medical membrane drops back to room temperature, the shape of the dense layer 10 is fixed, and the shape of the porous layer 20 remains consistent with the dense layer 10. In this way, the overall shape of the plastic medical membrane can be reshaped.

[0039] On the other hand, the viscosity of the first material is 0.20 dl / g to 1.87 dl / g, and the viscosity of the second material is 2.00 dl / g to 6.50 dl / g. It can be seen that the porous layer 20 contributes good physical properties to the plastic medical membrane to solve the problem of easy rupture of the previous isolation membrane.

[0040] In order to improve the convenience of use, the thickness of the plastic medical membrane of the present invention can be controlled to be 200 microns to 600 microns. In addition, in order to weigh the characteristics of plasticity and physical strength, the thickness of the dense layer 10 is adjusted to be less than or equal to the thickness of the porous layer 200. In some embodiments, the thickness of the dense layer 10 is 150 microns to 300 microns, and the thickness of the dense layer 10 can be 175 microns, 200 microns, 225 microns, 250 microns or 275 microns. The thickness of the porous layer 20 is 50 microns to 400 microns, and the thickness of the porous layer 20 can be 75 microns, 100 microns, 125 microns, 150 microns, 175 microns, 200 microns, 225 microns, 250 microns, 275 microns, 300 microns, 325 microns, 350 microns or 375 microns.

[0041] In some embodiments, by adjusting the properties of the first material, the present invention can also achieve that the plastic medical film has both plastic properties and good physical properties. In order to make the dense layer 10 plasticizable within the molding temperature range, the first material can be selected to be a biodegradable polymer with a weight average molecular weight of 5000g / mol to 50000g / mol. Preferably, the first material can be a biodegradable polymer with a weight average molecular weight of 10000g / mol to 30000g / mol. In one example, the first material includes polycaprolactone (PCL). However, the above example is only one feasible embodiment and is not intended to limit the present invention.

[0042] In addition, the second material can be another biodegradable polymer, and the second material can be a biodegradable polymer with a weight average molecular weight of 100,000 g / mol to 600,000 g / mol. Preferably, the second material can be a biodegradable polymer with a weight average molecular weight of 150,000 g / mol to 350,000 g / mol. In one example, the second material includes polylactic acid (PLA). However, the above example is only one feasible embodiment and is not intended to limit the present invention.

[0043] The plastic medical membrane of the present invention can be prepared by the following method, however, the present invention is not limited to the following example: In order to form the porous structure of the porous layer 20, the porous layer 20 can be made by non-woven spinning technology, freeze drying technology or electrostatic spinning technology.

[0044] Taking electrospinning technology as an example, when the porous layer 20 is prepared by spinning technology, an electrospinning liquid must be prepared first. The electrospinning liquid adopts a non-(low) toxicity formula, which mainly includes a polymer material and a solvent, the polymer material accounts for 1 to 50 weight percent of the total weight of the electrospinning liquid, and the solvent accounts for 50 to 99 weight percent of the total weight of the electrospinning liquid.

[0045] The polymer material may be selected from the group consisting of polylactic acid, polycaprolactone, polyhydroxyalkanoate (PHA) and polyglycolic acid (PGA). The solvent may be selected from the group consisting of acetone, butanone, ethylene glycol, isopropanol, deacetylated chitosan (DAC), N,N-dimethylformamide (DMF), dimethylacetamide (DMAC), dimethyl sulfoxide (DMSO) and ether.

[0046] In an exemplary embodiment, the polymer material is polylactic acid. In view of the stability and quality of spinning, the solvent is a mixture of acetone and dimethylacetamide, and the weight ratio of acetone to dimethylacetamide can be 1:9 to 9:1.

[0047] The prepared electrospinning liquid is added to a liquid storage tank, and the positive and negative electrodes of a high-voltage power supply are electrically connected to a nozzle and a collecting plate, respectively. After the high-voltage power supply is applied, the electrospinning liquid is ejected from the nozzle. Under the action of the electric field, the electrospinning liquid solidifies to form polymer fibers and is deposited on the collecting plate. By controlling the movement of the nozzle, the polymer fibers can be tightly stacked, entangled or interwoven in a specific direction, thereby forming a porous layer 20 with uniform thickness.

[0048] In an exemplary embodiment, the electrospinning temperature may be 5° C. to 95° C., and preferably 10° C. to 90° C. The voltage strength of the high voltage power supply is 5 kilovolts (KV) to 60KV, and preferably 10KV to 25KV. The ejection speed of the electrospinning liquid is 0.1cc / min to 5cc / min. There is a collection distance of 15 cm to 90 cm between the nozzle and the collection plate.

[0049] After the porous layer 20 is formed, the dense layer 10 is disposed on the porous layer 20 by heat pressing to complete the plastic medical membrane of the present invention. When the dense layer 10 is disposed on the porous layer 20 by heat pressing, a portion of the dense layer 10 is formed in the porous structure, so that the dense layer 10 and the porous layer 20 have good bonding strength.

[0050] In order to prove that the plastic medical membrane of the present invention can improve the defects of insufficient physical strength and lack of plasticity of the previous isolation membrane, after the plastic medical membrane was made according to the above method, the plastic medical membrane was subjected to tensile stress test and suture pull-out strength test, and compared with the existing isolation membranes on the market. The specific test results are listed in Table 1.

[0051] In Table 1, tensile stress (dry) refers to the tensile stress of the moldable medical film / existing isolation film tested at a temperature of 25°C and an absolute humidity of 50%. Tensile stress (wet) refers to the tensile stress of the moldable medical film / existing isolation film after being immersed in 37°C saline for 30 minutes. Suture pull-out strength is measured according to ISO 7198 test standard.

[0052] Table 1

[0053]

[0054] According to the results in Table 1, the plastic medical membrane of the present invention can have good tensile stress in both dry and humid environments. Even in a humid environment, the plastic medical membrane of the present invention can still maintain a certain tensile stress.

[0055] In contrast, the tensile stress of existing isolation membranes in humid environments is poor. Among them, although the cross-linked collagen membrane has extremely high tensile stress in a dry environment, once the environment becomes humid, the tensile stress of the cross-linked collagen membrane will drop significantly. Therefore, under certain operating conditions, the cross-linked collagen membrane still has the problem of poor physical properties. As for the uncross-linked collagen membrane and polylactic acid membrane, they all have the problem of poor physical properties regardless of dry or humid environments.

[0056] Specifically, the tensile stress of the plastic medical membrane of the present invention after being immersed in 37°C physiological saline for 30 minutes is greater than 10 MPa (tensile stress (wet)). The tensile stress at 25°C and 50% absolute humidity is greater than 10 MPa (tensile stress (dry)).

[0057] In addition, the plastic medical membrane of the present invention has a higher suture retention strength. Therefore, in actual use, the plastic medical membrane is less likely to break and has better convenience of use.

[0058] Specifically, the suture pull-out strength of the plastic medical membrane of the present invention according to the ISO 7198 test standard is 5N or more. Preferably, the suture pull-out strength of the plastic medical membrane is 8N or more. More preferably, the suture pull-out strength of the plastic medical membrane is 10N or more.

[0059] Accordingly, the plastic medical membrane of the present invention overcomes the defects of poor physical properties (tensile strength, suture pull-out strength) of the existing isolation membrane. In addition to good physical properties, the plastic medical membrane of the present invention also has the property of being plastic. Therefore, compared with the existing isolation membrane, the plastic medical membrane of the present invention has better convenience of use.

[0060] [Beneficial Effects of Embodiments]

[0061] One of the beneficial effects of the present invention is that the plastic medical membrane provided by the present invention can achieve the effect of improving the physical properties of the plastic medical membrane and making the plastic medical membrane have plastic properties through the technical solution of "the melting point of the dense layer 10 is within the plastic temperature range, and the melting point of the porous layer 20 is higher than the plastic temperature range".

[0062] Furthermore, the plastic medical membrane provided by the present invention can have plastic properties through the technical solution of "the melting point of the first material is lower than 100° C., and the melting point of the second material is higher than 100° C.".

[0063] Furthermore, the plastic medical membrane provided by the present invention can improve the physical properties of the plastic medical membrane and make the plastic medical membrane have plastic properties through the technical solution of "the viscosity of the first material is 0.20dl / g to 1.87dl / g" or "the viscosity of the second material is 2.00dl / g to 6.50dl / g".

[0064] Furthermore, the plastic medical membrane provided by the present invention can achieve the effect of improving the physical properties of the plastic medical membrane through the technical solution of "the porous layer 20 has a porous structure, and a part of the dense layer 10 is arranged in the porous structure".

[0065] The contents disclosed above are only preferred feasible embodiments of the present invention, and are not intended to limit the protection scope of the claims of the present invention. Therefore, all equivalent technical changes made using the contents of the present invention description and drawings are included in the protection scope of the claims of the present invention.

Claims

1. A plastic medical membrane, It is characterized in that The shaped medical film comprises: a dense layer, wherein the dense layer is formed of a first material and has no pores; and a porous layer, which is located on the dense layer, and the porous layer is formed of a second material and is made by electrospinning technology; The plastic medical membrane has a plastic temperature range, the melting point of the dense layer is within the plastic temperature range, and the melting point of the porous layer is higher than the plastic temperature range; Wherein, the thickness of the plastic medical membrane is 200 microns to 600 microns, and the thickness of the dense layer is less than or equal to the thickness of the porous layer; The molding temperature ranges from 45° C. to 100° C., the first material includes polycaprolactone, and the second material includes polylactic acid.

2. The plastic medical membrane according to claim 1, It is characterized in that When the shapeable medical membrane is at a temperature within the shaping temperature range, the dense layer is in a shapeable state, and the shape of the porous layer changes with the shape of the dense layer.

3. The plastic medical membrane according to claim 1, It is characterized in that The melting point of the first material is lower than 100°C, and the melting point of the second material is not lower than 100°C.

4. The plastic medical membrane according to claim 1, It is characterized in that The melting point of the first material is between 45°C and 70°C, and the melting point of the second material is between 100°C and 150°C.

5. The plastic medical membrane according to claim 1, It is characterized in that The viscosity of the first material is 0.20 dl / g to 1.87 dl / g.

6. The plastic medical membrane according to claim 1, It is characterized in that The viscosity of the second material is 2.00 dl / g to 6.50 dl / g.

7. The plastic medical membrane according to claim 1, It is characterized in that The porous layer has a porous structure, and a portion of the dense layer is disposed in the porous structure.

8. The plastic medical membrane according to claim 1, It is characterized in that The thickness of the dense layer is 150 micrometers to 300 micrometers.

9. The plastic medical film according to claim 1, It is characterized in that The thickness of the porous layer is 50 micrometers to 400 micrometers.

10. The plastic medical film according to claim 1, It is characterized in that The weight average molecular weight of the first material is 5000 g / mol to 50000 g / mol.

11. The plastic medical film according to claim 1, It is characterized in that The tensile stress of the plastic medical membrane after being immersed in physiological saline at 37° C. for 30 minutes is greater than 10 MPa.

12. The plastic medical film according to claim 1, It is characterized in that The tensile stress of the plastic medical film is greater than 10 MPa at a temperature of 25° C. and an absolute humidity of 50%.

13. The plastic medical membrane according to claim 1, It is characterized in that The suture pull-out strength of the plastic medical membrane according to the ISO7198 test standard is above 10N.

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