Fixing material and device for fracture patient and preparation method

Abstract

The invention relates to the technical field of orthopedic medical materials and instruments, and discloses a fixing material and device for a fracture patient and a preparation method.The fixing material is provided with an upper cover, a bottom plate, a filling layer and a photosensitive filling material, the filling layer and the photosensitive filling material are arranged between the upper cover and the bottom plate, and a plurality of supporting columns which protrude towards the skin of the patient and are arranged at intervals are arranged on the bottom plate; the skin of a patient is isolated from the bottom plate through the supporting columns. The fixing device for the fracture patient comprises a fixing material for the fracture patient and a connecting piece connected to the fixing material, and the connecting piece is used for fixing the fixing material for the fracture patient to the fracture part of the patient. According to the fixing material and device for the fracture patient and the preparation method, the fixing material and device for the fracture patient have better buffering and protecting effects on the orthopedic patient, are convenient to mount and dismount during use, are breathable, skin-friendly, light and convenient to use and have good performance, the preparation method is convenient and rapid, no glue is used in the whole manufacturing process, and the cost is low. Adverse reactions such as stimulation and sensitization on the human body are avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of orthopedic medical materials and instruments, and in particular to fixation materials, devices and preparation methods for fracture patients. Background Art

[0002] The statements in this section merely provide background art related to the present disclosure and do not necessarily constitute prior art.

[0003] During current clinical use, patients with fractures are fixed with plaster, that is, the specific fracture site is fixed with plaster. However, since the plaster covering the surface of the fracture site is not breathable, the rehabilitation effect of the fracture site is not good. At the same time, due to the airtightness, it causes skin problems. At the same time, if the plaster method is used, it is necessary to go to the hospital to remove the plaster after recovery. The operation is cumbersome, and the plaster site cannot be exposed to water at all, which affects normal life.

[0004] Another commonly used medical external fixation belt in clinical practice is a glass fiber material. Glass fiber is used to fix patients with fractures, and cotton rolls or cotton sleeves are used as pads at the specific fracture site. If there is no cotton sleeve, direct contact will cause the glass fiber material to adhere to the skin. After the medical external fixation belt hardens, the friction and pressure on the skin are more obvious. To remove the glass fiber material medical external fixation belt, latex gloves need to be worn to prevent sticking to the hands. Soak it in room temperature water for 3-5 seconds and squeeze it 2-3 times. After taking it out, squeeze out excess water, and wrap it in sequence according to the patient's fracture site. The tightness is generally moderate, and the overall operation is very cumbersome and complicated. The shaping and curing time is 3-5 minutes. When shaping and exposing the wound need to be completed within 3-5 minutes, the operator must complete the winding quickly. The operating time is too short. It can be completely cured after 20 minutes. If it accidentally comes into contact with water, it will soften due to the characteristics of the material and lose its curing effect on the original fracture site, causing secondary damage to the patient.

[0005] At present, there is a Chinese patent CN202322482293.9, which discloses a fixation device for fracture patients. The device includes a fixed body and a detachable connector arranged on the fixed body. The fixed body includes a skin-friendly layer, a first layer and a second layer. A filling cavity is formed between the first layer and the second layer, and the filling cavity is filled with a photosensitive layer; the fixed body is wrapped around the fracture site, and then the photosensitive layer is irradiated by a curing light source to harden it, thereby improving the strength of the entire fixed body and avoiding secondary damage to the fracture site. The skin-friendly layer is completely in contact with the skin during use. The material used in the skin-friendly layer is made of foam or sponge material. It is not good to be close to the skin and has poor air permeability. Long-term contact with the human body is prone to skin sensitization. The foam or sponge material is water-absorbent and not waterproof. Once it absorbs water, it is not easy to dry. At the same time, it is close to the skin, which will cause skin sensitization for a long time; the skin-friendly layer and the first layer need to be bonded with glue. The large area of ​​glue bonding has a pungent smell, which is easy to cause discomfort to the patient. The weight of the multi-layer stacking increases, which has a certain impact on the recovery of the patient's fracture site.

[0006] The main disadvantages of existing fixation devices for orthopedic patients are:

[0007] ① The foam or sponge used in the skin-friendly layer is close to the skin and has poor air permeability. Although it is a flexible material, it has the risk of irritation and allergy to the skin;

[0008] ②The skin-friendly layer is mainly sponge or foam. Once it comes into contact with water or high humidity, it has strong water absorption and is difficult to dry when it gets wet, causing the skin to be wrapped in airtight and humid conditions for a long time, which can easily lead to serious skin problems;

[0009] ③ The skin-friendly layer needs to be bonded with glue, which has a pungent odor and can easily cause discomfort to patients, and is also time-consuming and laborious;

[0010] ④Since the skin-friendly layer and the first silicone layer are bonded on the entire surface, a large amount of glue is required and the weight is heavy. The patient will bear the weight for a long time, which will affect his daily life;

[0011] ⑤ The foam or sponge material used in the skin-friendly layer is in close contact with the skin. During the actual light curing process, the material will generate slight heat. The foam or sponge is not conducive to heat dissipation, resulting in a large amount of heat accumulation and causing the risk of low-temperature burns. Summary of the invention

[0012] In order to overcome the shortcomings of the above-mentioned prior art, the present invention provides a product with strong air permeability, high comfort and excellent waterproof performance, which is convenient for wound recovery and does not affect the patient's daily water activities such as bathing and swimming. At the same time, the product material is highly accessible, the manufacturing cost is low and it is more environmentally friendly, providing safe and comfortable protection for patients.

[0013] The technical solution adopted by the present invention is: a fixation material for fracture patients, comprising an upper cover and a bottom plate, and a filling layer and a photosensitive filling material arranged between the upper cover and the bottom plate, wherein a plurality of support columns protruding toward the patient's skin and arranged at intervals are arranged on the bottom plate, and the plurality of support columns isolate the patient's skin from the bottom plate, forming a dispersed breathable isolation and waterproof layer between the bottom plate and the patient.

[0014] In the technical solution, the filling layer is a plurality of filling grooves arranged at intervals in the upper cover, and the photosensitive filling material is filled in the corresponding filling grooves.

[0015] In the technical solution, the bottom plate and a plurality of support columns are connected to form an integrated structure.

[0016] In the technical solution, the support columns are evenly distributed on the base plate.

[0017] In the technical solution, the upper cover and the bottom plate are made of any one of silicone, PVC and TPU or a combination of two of them.

[0018] A fixation device for patients with fractures comprises a fixation material for patients with fractures and a connector connected thereto, wherein the connector is used to fix the fixation material for patients with fractures at the fracture site of the patient.

[0019] In the present technical solution, the connecting piece is a quick-detachable component, which is respectively fixed on both sides of the fixation material for the fracture patient so as to achieve quick installation and disassembly.

[0020] In the technical solution, the connecting piece is a Velcro assembly or a zipper assembly or a snap assembly, which is respectively connected to the two sides of the fixation material for the fracture patient.

[0021] The preparation process of fixation materials for fracture patients includes at least:

[0022] S1. Use the upper cover mold and the lower cover film to form an upper cover with a filling layer;

[0023] S2. Using the bottom plate mold and the bottom plate under the film pressed together to form a bottom plate having several support columns;

[0024] S3 bonds the upper cover to the bottom plate;

[0025] S4. Liquid photosensitive resin is poured into the filling layer of the upper cover to obtain a fixation material for fracture patients.

[0026] Compared with the prior art, the present invention has the following beneficial effects:

[0027] (1) The part of the material that comes into direct contact with the patient's skin is soft, providing better cushioning and protection for the patient's fracture site;

[0028] (2) The bottom plate has a plurality of support columns arranged at intervals and protruding toward the patient's skin, which can improve the air permeability. After the patient contacts the water, the water will flow out immediately and evaporate easily without affecting the skin;

[0029] (3) The upper cover and the bottom plate can be integrally formed, which is convenient and quick to manufacture. No glue is used in the entire manufacturing process, which will not cause adverse reactions such as irritation and sensitization to the human body;

[0030] (4) The material is lightweight and convenient for daily use by patients. It is not restricted by time or space and can be used at any time. It is easy to disassemble and quick.

[0031] In summary, the fixation material, device and preparation method for fracture patients of the present invention have obtained a fixation material and device for fracture patients which has better cushioning and protection for orthopedic patients, is easy to install and disassemble during use, and has good breathability, skin-friendliness, and lightness to use. The preparation method is convenient and fast, no glue is used in the entire manufacturing process, and no adverse reactions such as irritation and sensitization are produced to the human body. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 A three-dimensional structural diagram of the skin-friendly side of an embodiment of a fixation material for fracture patients;

[0033] Figure 2 for Figure 1 An enlarged view of A of an embodiment;

[0034] Figure 3 for Figure 1 A three-dimensional structural diagram of another side of the embodiment;

[0035] Figure 4 for Figure 3 A magnified view of point B;

[0036] Figure 5 for Figure 1 A three-dimensional structural diagram of an embodiment in which the upper cover and the bottom plate are separated;

[0037] Figure 6 A three-dimensional structural diagram of an embodiment of a fixation device for fracture patients;

[0038] Figure 7 A structural diagram of the skin-friendly side of an embodiment of a base plate;

[0039] Figure 8 A structural diagram of an embodiment of a fixation device for fracture patients in which the connecting member of the fixation device for fracture patients is a zipper structure;

[0040] Fig. 9 A three-dimensional structural diagram of an embodiment of a fixation device for a patient with a fracture of a finger;

[0041] Fig.10 A process diagram for preparing the upper cover;

[0042] Fig.11 Prepare process diagram for base plate;

[0043] Fig.12 This is the process diagram for pouring the upper cover;

[0044] Fig.13 for Fig. 9 A side view of an embodiment of a fixation device for a fracture patient;

[0045] Among them: 100-fixation material for fracture patients, 110-upper cover, 120-bottom plate, 130-filling layer, 140-photosensitive filling material, 150-support column, 160-finger jack; 200-connecting piece, 300-upper mold of upper cover, 400-lower film of upper cover, 500-upper mold of bottom plate, 600-lower film of bottom plate, 700-pouring needle. DETAILED DESCRIPTION

[0046] Embodiments of the present invention are described in detail below, examples of which are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and cannot be understood as limiting the present invention.

[0047] In the description of the present invention, it should be understood that the terms "center", "up", "down", "front", "back", "left", "right" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the combination or element referred to must have a specific position, be constructed and operated in a specific position, and therefore cannot be understood as limiting the present invention. In addition, in the description of the embodiments of the present invention, the device positional relationships such as "up", "down", "front", "back", "left", "right" and the like in all the drawings are based on the positions or positional relationships shown in the accompanying drawings. Figure 1 As standard.

[0048] like Figure 1As shown, the fixation material 100 for fracture patients comprises an upper cover 110 and a bottom plate 120, and a filling layer 130 and a photosensitive filling material 140 arranged between the upper cover 110 and the bottom plate 120. The bottom plate 120 is provided with a plurality of support columns 150 protruding toward the patient's skin and arranged at intervals. The plurality of support columns 150 isolate the patient's skin from the bottom plate 120 to form a dispersed breathable isolation waterproof layer, so that the photosensitive filling material 140 cannot directly contact the patient's skin, which has the following three advantages: (1) it can effectively prevent the patient's skin from being scalded by the heat released during the light curing process of the photosensitive filling material 140, and has a good heat insulation effect; (2) on the other hand, the use of these support columns 150 can ensure that when the patient wears the fixation material and water enters, the water entering can be evacuated from between the support columns 150 and flow out to the outside without water accumulation; (3) at the same time, since the support columns 150 are dispersedly arranged protruding toward the patient's skin, their heat dissipation and ventilation and air permeability performance on the patient's skin surface are also good.

[0049] In the embodiment of the fixation material for fracture patients, in the initial state, the orthopedic fixation material 100 is naturally expanded as shown in FIG. Figure 1 When in use, the orthopedic fixation material 100 is fitted to the fracture site of the human body, thereby forming a wrapped and rolled orthopedic fixation material 100, and the orthopedic fixation material 100 has a plurality of contoured models according to different fracture sites to adapt to different fracture sites, such as arms, palms, legs, etc., such as Fig. 9 and Fig.13 As shown, the orthopedic fixation material 100 and the fixation device for fracture patients are designed with a finger jack 160 for finger fixation. In actual use, the shape, size and curling angle of the orthopedic fixation material 100 can be selected according to the specific fracture site. Through the quickly detachable connector 200 on the orthopedic fixation material 100, according to the size of the patient's injured part, it is adjusted to a comfortable position and fixed. The operation is simple for personnel, and then the surface of the orthopedic fixation material 100 is evenly irradiated one by one by a curing blue light source until the entire liquid photosensitive resin is completely cured. The specific use time is based on the size of the fracture site. The model of the appropriate orthopedic fixation material is selected. The liquid photosensitive resin instantaneous curing time is 5s. The entire surface is evenly irradiated according to the size of the area of ​​different models. The entire light curing generally takes 5-8 minutes. After the curing is completed, the material strength is reliable, and it has better binding force on the fracture site, which is helpful for the recovery of the fracture site. At the same time, the orthopedic fixation material 100 is specifically a porous structure, and the orthopedic fixation material-bottom plate has a spaced and dispersed breathable isolation and waterproof layer structure formed by fixing a plurality of support columns 150 on the bottom plate 120, such as Figure 1 , Figure 2 and Figure 7As shown, after the orthopedic fixation material 100 fixes the fracture site, the spaced apart breathable isolation and waterproof layer structure is as shown in FIG. Figure 1 , Figure 2 and Figure 7 As shown, the air permeability of the fracture site can be directly improved, which is beneficial to the breathing of the skin, has no irritation to the skin, does not retain water, has good water permeability, does not affect the daily life of contact with water, is beneficial to the recovery of the fracture site and can also improve the comfort of fracture patients. The orthopedic fixation material has a variety of different models according to the shape of different parts of the human body, and the embodiment is only an example of one model.

[0050] In at least one embodiment, Figure 3 , Figure 4 and Figure 5 As shown, the filling layer 130 is a plurality of filling grooves arranged at intervals in the upper cover 110 or arranged at intervals in the upper cover 110 and the bottom plate 120, and the photosensitive filling material 140 is filled in the corresponding filling grooves. This structural design has two main advantages. First, it can make full use of the flexibility of the upper cover 110 and the bottom plate 120 to adaptively bend and fix the patient's treatment part, and second, it can realize multi-point photosensitive thermal curing of the patient's treatment part, completely cover the patient's treatment part, and fix it in all directions. During the implementation of this technical solution, a plurality of filling grooves can be arranged at intervals in the upper cover 110 as a filling layer; a plurality of filling grooves can also be arranged at intervals in the upper cover 110 as a filling layer, and corresponding filling grooves are also arranged at the position of the bottom plate 120 corresponding to the filling grooves on the upper cover 110, so that more photosensitive filling material 140 can be filled between the upper cover 110 and the bottom plate 120 of the same thickness, so as to enhance its curing effect, and at the same time make the entire fracture patient fixation material 100 lighter.

[0051] In at least one embodiment, Figure 1 , Figure 2 and Figure 7 As shown, the bottom plate 120 and the plurality of support columns 150 are connected to form an integrated structure, thereby ensuring that the plurality of support columns 150 have sufficient support performance for the bottom plate 120 and are not easy to fall off during use. The support columns 150 are evenly distributed on the bottom plate 120, thereby further enhancing the uniform support performance of the fixation material for fracture patients.

[0052] In at least one embodiment, the upper cover 110 and the bottom plate 120 are made of any one of silicone, PVC and TPU or a combination of two thereof, and both are soft, comfortable and skin-friendly. The photosensitive filling material 140 is a liquid photosensitive resin, and is photosensitive. Curing effect.

[0053] Patients with fractures use immobilization devices, such as Figure 5and Figure 6 As shown, it includes a fixation material 100 for fracture patients and a connector 200 connected thereto, and the connector 200 is used to fix the fixation material 100 for fracture patients at the fracture site of the patient.

[0054] In at least one embodiment, the connector 200 is a quick-detach component, which is fixed to both sides of the fixation material 100 for fracture patients, so as to achieve quick installation and removal.

[0055] In at least one embodiment, the connector 200 is a Velcro assembly or a zipper assembly or a snap assembly, which is respectively connected to both sides of the fixation material 100 for fracture patients, and the connection can be completed by combining standard parts and fine-tuning, so as to facilitate processing and use, take into account both economy and practicality, and better quickly open or close to achieve connection. Figure 5 and Figure 6 In the embodiment shown, the connector 200 is a Velcro assembly. Figure 8 The connecting member 200 in the embodiment is a zipper structure.

[0056] The preparation process of fixation materials for fracture patients is carried out under the processing environment requirements of temperature 18-28°C and humidity 40%-80%. The preparation process steps include at least:

[0057] S1. Fig.10 As shown, the upper cover upper mold 300 and the upper cover lower film 400 are pressed together to form the upper cover 110 with the filling layer 130; the material hardness of the upper cover 110 is selected to be 10A-50A; the ratio of the vulcanizing agent is 1-3%; the number of rubber mixing is 15-30 times; the thickness requirement: the thickness parameter controlled by the upper cover 110 is 2-3mm; the temperature of the molding equipment is 120-140°C, the pressure is 20-30MPA, and the extrusion control insulation time is 10-15 minutes;

[0058] S2. Fig.11 As shown, the bottom plate upper mold 500 and the bottom plate lower film 600 are pressed together to form a bottom plate 120 with a plurality of support columns 150; the material hardness of the bottom plate 120 in this embodiment is 10A-50A; the ratio of the vulcanizing agent is 1-3%; the required masterbatch is added, and this product uses green as an example, and the ratio of the green masterbatch is 2‰-3‰; the number of rubber mixing is 20-30 times; the thickness requirement: the thickness parameter controlled by the bottom plate is 1-1.5mm; the temperature of the molding equipment is 160-170℃, the pressure is 20-30MPA, and the extrusion control insulation time is 10-15 minutes;

[0059] S3: bonding the upper cover 110 and the bottom plate 120;

[0060] S4. Fig.12As shown, a pouring needle 700 is used to pour liquid photosensitive resin into the filling layer 130 of the upper cover 110 to obtain a fixation material 100 for fracture patients. When pouring the liquid photosensitive resin, the filling speed is 20 mL / s, and the diameter of the filling needle is 3.5-4.5 mm. After the filling is completed, the filling port is blocked to complete the sealing.

[0061] In at least one embodiment, when the upper cover 110 and the bottom plate 120 are bonded, vacuum plasma treatment is performed to make the bonding surface reach 44-50 dyn / cm, and then high-temperature pressing is performed, wherein: the temperature of the molding equipment is 160-170° C., the pressure is 10-20 MPA, and the pressing and holding time is 10-15 minutes, so as to complete the bonding of the upper cover 110 and the bottom plate 120;

[0062] Alternatively, when the upper cover 110 and the bottom plate 120 are bonded, a layer of silicone is evenly coated on the bonding surface of the upper cover 110 and the bottom plate 120, and then they are pressed at high temperature, wherein: the temperature of the molding equipment is 120-140°C, the pressure is 10-20MPA, and the pressing and heat preservation time is 10-15 minutes, and the bonding of the upper cover 110 and the bottom plate 120 is completed, and the bonding of the upper cover 110 and the bottom plate 120 can be well achieved.

[0063] The fixation material or fixation device for fracture patients prepared by the above preparation process has better cushioning and protection, is easy to install and disassemble during use, and is breathable, skin-friendly, and light to use. The fixation material and device for fracture patients have good performance, and the preparation method is convenient and fast. No glue is used in the entire manufacturing process, and no adverse reactions such as irritation and sensitization will be generated to the human body. The comparison table of the advantages and disadvantages of specific orthopedic materials is shown in Table 1.

[0064] Table 1 Comparison of the advantages and disadvantages of orthopedic materials

[0065] name plaster Fiberglass Orthopedic fixation materials (this product) Operation difficulty high generally none Hardening time 24 hours 3-5 minutes Hardens immediately Full curing time 24-72 hours 20 minutes 5-8 minutes weight Heavy medium light Breathability none Small Comfort Comfort Low medium high Waterproof none No (water softening) 100％ Skin effects Big risks Big risks Low risk

[0066] In summary, the orthopedic fixation material prepared by the preparation process of the fixation material for fracture patients of the present invention has the following advantages over the fixation devices for fracture patients made of existing gypsum materials and glass fiber materials:

[0067] ①The material is highly safe, non-toxic, harmless, and has no irritating odor;

[0068] ②The material has strong plasticity, is easy to shape and simple to manufacture;

[0069] ③ Extrusion molding process, supporting equipment is easy to obtain, the production is simple, and the production cost is saved.

[0070] The embodiments of the present invention disclose preferred embodiments, but are not limited thereto. A person skilled in the art can easily understand the spirit of the present invention based on the above embodiments and make different extensions and changes. However, as long as they do not deviate from the spirit of the present invention, they are all within the protection scope of the present invention.

Claims

1. A fixation material for fracture patients, comprising an upper cover (110) and a bottom plate (120), and a filling layer (130) and a photosensitive filling material (140) arranged between the upper cover (110) and the bottom plate (120), characterized in that: The bottom plate (120) is provided with a plurality of support columns (150) arranged at intervals and protruding toward the patient's skin, so as to form a breathable, isolating and waterproof layer at intervals between the bottom plate (120) and the patient.

2. The fixation material for fracture patients according to claim 1, characterized in that: The filling layer (130) is a plurality of filling grooves arranged at intervals in the upper cover (110) or arranged at intervals in the upper cover (110) and the bottom plate (120), and the photosensitive filling material (140) is filled in the corresponding filling grooves.

3. The fixation material for fracture patients according to claim 1 or 2, characterized in that: The bottom plate (120) and a plurality of support columns (150) are connected to form an integrated structure.

4. The fixation material for fracture patients according to claim 3, characterized in that: The support columns (150) are evenly distributed on the bottom plate (120).

5. The fixation material for fracture patients according to claim 4, characterized in that: The upper cover (110) and the bottom plate (120) are made of any one of silica gel, PVC and TPU or a combination of two thereof, and the photosensitive filling material (140) is liquid photosensitive resin.

6. A fixation device for fracture patients, characterized in that: The invention comprises a fixing material (100) for patients with fractures and a connecting piece (200) connected thereto, wherein the connecting piece (200) is used to fix the fixing material (100) for patients with fractures at the fracture site of the patient.

7. The fixation device for fracture patients according to claim 6, characterized in that: The connecting piece (200) is a quick-detachable component, which is respectively fixed on both sides of the fixation material (100) for fracture patients.

8. The fixation device for fracture patients according to claim 7, characterized in that: The connecting piece (200) is a Velcro assembly, a zipper assembly, or a snap assembly, and is respectively connected to both sides of the fixation material (100) for fracture patients.

9. A process for preparing a fixation material for fracture patients, characterized in that: At least: S1. Using the upper cover mold (300) and the upper cover lower film (400) to form an upper cover (110) with a filling layer (130); S2. Using the bottom plate upper mold (500) and the bottom plate lower film (600) to form a bottom plate (120) having a plurality of support columns (150); S3: bonding the upper cover (110) and the bottom plate (120); S4. Pour liquid photosensitive resin into the filling layer (130) of the upper cover (110) to obtain a fixation material for fracture patients.

10. The process for preparing the fixation material for fracture patients according to claim 9, characterized in that: When the upper cover (110) and the bottom plate (120) are bonded, vacuum plasma treatment is performed to make the bonding surface reach 44-50 dyn / cm, and then high-temperature pressing is performed, wherein: the temperature of the molding equipment is 160-170° C., the pressure is 10-20 MPa, and the pressing and heat preservation time is 10-15 minutes, so as to complete the bonding of the upper cover (110) and the bottom plate (120); Alternatively, a layer of silicone is uniformly coated on the bonding surface of the upper cover (110) and the bottom plate (120), and then the bonding is completed by high-temperature pressing, wherein: the temperature of the molding equipment is 120-140°C, the pressure is 10-20MPA, and the pressing and heat preservation time is 10-15 minutes, so as to complete the bonding of the upper cover (110) and the bottom plate (120).

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