Inner liner forming device and inner liner forming process
Through the inner liner forming device, the filling and swelling technology of elastic-plastic materials is used to solve the problems of waste and high cost of gypsum molds in the prior art, and the efficient and environmentally friendly forming of the inner liner is achieved, reducing production costs and improving production efficiency .
Patent Information
- Application Number
- CN202011438092.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2020-12-07
- Publication Date
- 2024-12-24
- Estimated Expiration
- 2040-12-07
AI Technical Summary
Disposable gypsum molding is required in the existing prosthetic limb inner lining molding process, resulting in high production costs, serious waste, uneco-friendly and troublesome process.
An inner liner forming device is adopted, which includes an outer capsule body and an inner capsule body of an elastic-plastic material that is easily deformed. By swelling the filling material, the inner liner raw material forms a matching shape in the prosthetic receiving cavity to achieve molding of the inner liner.
It reduces the production and scrapping costs of gypsum molds, reduces the manufacturing cost of inner bushings, improves production efficiency and environmental protection, and facilitates the secondary production of inner bushings.
Smart Images

Figure CN112706345B_ABST
Abstract
Description
Technical Field
[0001] The invention relates to the field of prostheses, and in particular to an inner liner sleeve molding device and an inner liner sleeve molding process using the molding device. Background Art
[0002] The prosthetic liner is the link between the residual limb and the prosthetic socket, and plays a vital role in the prosthesis. It has the function of inserting the prosthesis and buffering the force. The realization of these functions will stimulate the skin and muscle tissue of the residual limb. If it is not handled properly, it will cause discomfort to the amputee or even limb damage.
[0003] At present, the forming process of the inner liner is roughly as follows:
[0004] A plaster bandage is used to take a mold of the patient's residual limb to make a negative plaster mold, the shape of which matches the shape of the residual limb;
[0005] Injecting gypsum slurry into the inner cavity of the gypsum female mold, and obtaining a gypsum male mold after the slurry solidifies, taking it out, and reshaping the gypsum male mold, so that the shape of the gypsum male mold is consistent with the shape of the residual limb;
[0006] The inner liner material is rolled into a cone-like shape, put on the outside of the plaster positive mold, heated, and then sealed with a plastic sleeve, and the plastic sleeve is vacuumed to stretch and shape the material and fit completely on the plaster positive mold; after cooling, the finished inner liner is taken out, and the inner cavity of the inner liner is completely matched with the plaster positive mold, that is, it completely matches the shape of the patient's residual limb.
[0007] After the inner sleeve is made, the prosthetic receiving cavity is made according to the shape of the inner sleeve (the shape of the prosthetic receiving cavity matches the inner sleeve, and the prosthetic receiving cavity is the outer shell of the prosthesis. The manufacturing process mainly involves putting a layer of plastic bag on the outside of the inner sleeve, then injecting material and grouting, and then putting another layer of plastic bag on the outside. After solidification, the outer sleeve prosthetic receiving cavity is obtained). The inner sleeve is placed in the prosthetic receiving cavity for use.
[0008] In summary, the idea and sequence of the existing prosthetic molding process are roughly as follows: based on the shape of the residual limb, a plaster mold is first made, then an inner sleeve is made, and finally a receiving cavity is made. However, since the shape of each patient's residual limb is different, and the inner sleeve is customized according to the patient's individual situation, it is determined that a plaster mold must be made for each inner sleeve. After the inner sleeve is manufactured, the plaster mold needs to be broken and scrapped.
[0009] The existing process has major defects: (1) The production of plaster molds is costly and takes up a lot of space. Plaster is also fragile and needs to be carefully stored. (2) Each plaster mold can only be used once before it is scrapped, which causes great waste. The production cost is difficult to reduce. In addition, plaster molds are not environmentally friendly and cannot be recycled. (3) The scrapping of plaster molds is also time-consuming and labor-intensive. After breaking them, the fragments need to be cleaned up and transported away, and the waste disposal cost is very high. (4) When the patient needs to replace the inner sleeve due to atrophy of the residual limb or contamination of the inner sleeve, the plaster mold needs to be remade, which is very troublesome. Summary of the invention
[0010] In order to overcome the shortcomings of the prior art, one of the objects of the present invention is to provide an inner sleeve molding device, which can solve the problem that the inner sleeve molding in the prior art must adopt a gypsum mold; the second object of the present invention is to provide an inner sleeve molding process applied to the inner sleeve molding device, which can solve the problem that the prior art must first make a gypsum mold and then make the inner sleeve, resulting in high production cost, high cost of replacing the inner sleeve, high processing cost, non-environmental protection, and complicated process.
[0011] The present invention is achieved by adopting the following technical solutions:
[0012] A liner forming device comprises: an outer bladder and a base; the outer bladder is made of an elastic-plastic material that is easy to deform, the bottom of the outer bladder is circumferentially fixedly connected to the base, and a filling space for accommodating filling material is formed between the outer bladder and the base; an openable and closable filling nozzle is provided at the bottom of the base, and the filling nozzle is communicated with the filling space.
[0013] Furthermore, the inner liner forming device also includes an inner sac body and a stretching rope; the inner sac body is an elastic-plastic material that is easy to deform, and is arranged inside the outer sac body. A stretching through hole is also provided on the base, and the bottom of the inner sac body is circumferentially fixedly connected to the side of the stretching through hole; the upper surface of the top of the inner sac body is fixedly connected to the lower surface of the top of the outer sac body; one end of the stretching rope is fixedly connected to the lower surface of the top of the inner sac body, and the other end passes through and extends out of the stretching through hole.
[0014] Furthermore, the material of the outer capsule is any one of silicone and rubber.
[0015] Furthermore, the material of the inner capsule is any one of silicone and rubber.
[0016] Furthermore, the filling material is any one of air and sand.
[0017] An inner sleeve forming process applied to the inner sleeve forming device is characterized in that it includes the following steps: a prosthetic receiving cavity taking step: making a new prosthetic receiving cavity according to the shape of the patient's residual limb; or directly taking the existing old prosthetic receiving cavity; a step of placing the inner sleeve raw material: taking the inner sleeve raw material according to the required thickness and volume requirements of the inner sleeve, and placing the inner sleeve raw material into the prosthetic receiving cavity; a heating step: heating the inner sleeve raw material so that the inner sleeve raw material is heated to have good ductility; a filling and extrusion molding step: placing the inner sleeve molding device into the prosthetic receiving cavity so that the inner sleeve raw material is located in the desired between the prosthesis receiving cavity and the inner liner forming device; opening the filling nozzle, filling the interior of the outer bladder to make the outer bladder swell, the outer bladder exerts a force on the inner liner raw material, and the inner liner raw material is tightly pressed into the prosthesis receiving cavity, so that the outer surface of the inner liner matches the inner surface of the prosthesis receiving cavity, and the inner surface shape of the inner liner is consistent with the inner surface shape of the prosthesis receiving cavity; cooling and molding step: opening the filling nozzle to let the filling material leak out, taking out the inner liner forming device, and after the inner liner raw material is cooled and molded, a finished inner liner is obtained and taken out.
[0018] Furthermore, before the filling and extrusion molding steps, an adjustment step is also included: according to the specific size of the patient's residual limb, the stretch rope is pulled downward and fixed to reduce the length of the outer balloon, thereby adjusting the size of the filling space to adapt to the specific size of the patient's residual limb.
[0019] Furthermore, the step of obtaining the prosthetic receiving cavity is a 3D printing step: producing a residual limb contour model by means of a 3D scanning device; digitally shaping the residual limb contour 3D module according to the residual limb contour 3D model, according to the prosthetic shaping principle and computer-aided software, establishing a 3D model of the inner surface curved surface of the prosthetic receiving cavity; establishing a 3D model of the prosthetic receiving cavity with a solid thickness according to the 3D model of the inner surface curved surface; performing 3D printing and molding according to the 3D model of the prosthetic receiving cavity to obtain the finished product of the prosthetic receiving cavity.
[0020] Furthermore, in the heating step, the heating temperature is 60°C to 100°C.
[0021] Furthermore, the inner liner sleeve is made of any one of EVA, polyurethane, silicone grease and gel grease.
[0022] Compared with the prior art, the present invention can achieve the following beneficial effects:
[0023] The inner sleeve forming process adopts a completely different process method from the past. First, take the prosthetic receiving cavity. You can make a new prosthetic receiving cavity according to the shape of the patient's residual limb, or you can take the old prosthetic receiving cavity that has been made (the shape of the prosthetic receiving cavity matches the shape of the residual limb). Then put the inner sleeve raw material into the prosthetic receiving cavity. After heating to an appropriate temperature, put the inner sleeve forming device into the receiving cavity to fill it and make the outer capsule swell. Since the inner sleeve forming device itself has no fixed shape, after filling and swelling, the shape of the outer capsule will be limited by the inner surface of the prosthetic receiving cavity, and its shape is consistent with the shape of the residual limb. In this process, the outer capsule exerts a force on the inner sleeve raw material, so that the inner sleeve raw material fits tightly on the inner surface of the prosthetic receiving cavity. Since the heated inner sleeve raw material has good ductility, the outer surface shape of the inner sleeve matches the inner surface shape of the prosthetic receiving cavity. At the same time, the inner surface shape of the inner sleeve is the same as the inner surface shape of the prosthetic receiving cavity, which is also a shape that just matches the shape of the residual limb. After forming, the inner sleeve finished product is obtained.
[0024] In the whole process, the forming device plays a role in shaping the inner sleeve. Since the forming device itself is made of elastic-plastic material that is easy to deform, it produces bulging through filling. Since it has no fixed shape, it can adapt to any shape of the prosthetic receiving cavity to shape the inner sleeve raw material.
[0025] By using the inner sleeve molding device of the present invention to implement the process, only one set of molding devices is needed to adapt to the production of inner sleeves of various shapes, and there is no need to customize plaster molds according to each different residual limb shape, which directly saves the high production cost, transportation cost, storage cost, scrapping cost, and cleaning cost of the previous plaster molds, reduces waste, greatly reduces the manufacturing cost of the inner sleeve, and greatly improves production efficiency and production benefits. At the same time, because the molding device can be used multiple times, it has the advantage of being green and environmentally friendly; in addition, when the patient needs to replace the inner sleeve due to residual limb atrophy or the inner sleeve being contaminated, the molding device and molding process can facilitate the secondary production of the inner sleeve without the need for additional molds, which brings great convenience to the patient. BRIEF DESCRIPTION OF THE DRAWINGS
[0026] Figure 1 Shown is a front cross-sectional view of the inner liner forming device;
[0027] Figure 2 Shown is a side cross-sectional view of the liner sleeve forming device;
[0028] Figure 3 Shown is a cross-sectional view of the inner liner forming device in a stretched adjustment state;
[0029] Figure 4 Shown is a flow chart of the liner forming process.
[0030] In the figure: 10, outer capsule; 20, base; 21, stretching hole; 30, filling space; 40, filling nozzle; 50, inner capsule; 60, stretching rope. DETAILED DESCRIPTION
[0031] The present invention is further described below in conjunction with the accompanying drawings and specific implementation methods. It should be noted that, under the premise of no conflict, the various embodiments or technical features described below can be arbitrarily combined to form a new embodiment.
[0032] See also Figure 1-Figure 3 The present invention discloses an inner liner forming device, including an outer bladder 10 and a base 20. The outer bladder 10 is an elastic-plastic material that is easy to deform, and the bottom of the outer bladder 10 is circumferentially fixedly connected to the base 20. More specifically, the bottom of the outer bladder 10 is sleeved outside the base 20, so that a filling space 30 for accommodating filling materials is formed between the outer bladder 10 and the base 20; a freely openable and closable filling nozzle 40 is provided at the bottom of the base 20, one end of the filling nozzle 40 is connected to the filling space 30, and the other end extends out of the lower part of the base 20. When there is no content in the filling space 30, the outer bladder 10 is collapsed. When the filler is injected into the filling space 30 through the filling nozzle 40, the outer bladder 10 swells, and its specific shape will change according to the external restriction. For example, the molding device is placed in a hemispherical prosthesis receiving cavity, which is filled and bulged, and the outer capsule 10 with good plasticity will be restricted by the hemispherical shape, and the outer capsule 10 will adapt to form a hemispherical shape; the same applies to other shapes.
[0033] Preferably, the inner liner forming device further comprises an inner capsule 50 and a stretching rope 60. The inner capsule 50 is also made of an elastic-plastic material that is easy to deform, and is arranged inside the outer capsule 10. A stretching through hole 21 is also provided on the base 20, and the bottom of the inner capsule 50 is circumferentially fixedly connected to the side of the stretching through hole 21. The upper surface of the top of the inner capsule 50 and the lower surface of the top of the outer capsule 10 are fixedly connected. It should be noted that the inner capsule 50 and the outer capsule 10 are fixedly connected only by one end point, rather than the entire outer surface of the inner capsule 50 and the entire inner surface of the outer capsule 10 are completely bonded. One end of the stretching rope 60 is fixedly connected to the lower surface of the top of the inner capsule 50, and the other end passes through and extends out of the stretching through hole 21.
[0034] In the case of setting the inner capsule 50, the filling space 30 is actually the size of the cavity formed between the inner capsule 50 and the outer capsule 10. When the stretching rope 60 is pulled downward, the inner capsule 50 will drive the top of the outer capsule 10 to move downward, and then the stretching rope 60 is fixed, which is equivalent to compressing the size of the filling space 30. The size adjustment of the molding device is achieved through the stretching rope 60 and the inner capsule 50.
[0035] Preferably, the material of the outer capsule 10 can be any one of silicone and rubber, or other known materials with good heat resistance and elasticity and plasticity; preferably, the material of the inner capsule 50 can be any one of silicone and rubber, or other known materials with good heat resistance and elasticity and plasticity.
[0036] Preferably, the filling material can be any one of air and sand, or other known materials with strong plasticity and easy filling. In the present invention, the preferred filling material is air, and the gas is directly injected or released into the outer capsule 10, which has the advantages of convenience, speed and cost saving.
[0037] Specifically, the filling nozzle 40 is a valve, which is connected to the filling space 30 .
[0038] The present invention also discloses an inner sleeve forming process applied to the inner sleeve forming device, see Figure 4 , including at least the following steps:
[0039] The step of obtaining a prosthetic receiving cavity: making a new prosthetic receiving cavity according to the shape of the patient's residual limb; or directly taking an existing old prosthetic receiving cavity; specifically, a new prosthetic receiving cavity can be made for the patient using an existing method, or the patient's old prosthetic receiving cavity in use can be directly taken and the inner liner raw material can be placed in the step of: taking the inner liner raw material according to the required thickness and volume requirements of the inner liner, and placing the inner liner raw material in the prosthetic receiving cavity, more specifically, when placing the inner liner raw material, the inner liner raw material can be well attached to the inner surface of the prosthetic receiving cavity, so as to facilitate subsequent extrusion molding;
[0040] Pressurizing step: heating the inner liner material so that the inner liner material is heated to have good ductility;
[0041] Filling and extrusion molding steps: discharge the filling material in the above-mentioned inner liner molding device, place the inner liner molding device into the prosthesis receiving cavity, and make the inner liner raw material be located between the prosthesis receiving cavity and the inner liner molding device; open the filling nozzle 40, fill the inside of the outer balloon 10, so that the outer balloon 10 swells, and the swollen outer balloon 10 applies force to the inner liner raw material, and presses the inner liner raw material tightly onto the inner surface of the prosthesis receiving cavity; since the inner liner raw material has good ductility, after pressing, the outer surface of the inner liner and the inner surface of the prosthesis receiving cavity match each other, and since the inner liner molding device applies force to various parts of the inner liner raw material, the thickness of the inner liner at various parts is basically consistent, and the inner surface shape of the inner liner is consistent with the inner surface shape of the prosthesis receiving cavity, that is, it matches the shape of the patient's residual limb;
[0042] Cooling and molding step: open the filling nozzle 40 to allow the filling material to leak out, take out the inner liner molding device, and after the inner liner raw material is cooled and molded, obtain the inner liner finished product and take it out.
[0043] The technical effect that can be achieved by the process method disclosed in the present invention is: the inner sleeve molding process adopts a completely different process method from the past. First, a prosthetic receiving cavity is taken. A new prosthetic receiving cavity can be made according to the shape of the patient's residual limb, or an old prosthetic receiving cavity that has been made can be taken (the shape of the prosthetic receiving cavity matches the shape of the residual limb), and then the inner sleeve raw material is placed in the prosthetic receiving cavity. After heating to an appropriate temperature, the inner sleeve molding device is placed in the receiving cavity to fill it so that the outer capsule 10 is inflated. Since the inner sleeve molding device itself has no fixed shape, after filling and swelling, the shape of the outer capsule 10 will be limited by the inner surface of the prosthetic receiving cavity, and its shape is consistent with the shape of the residual limb. In this process, the outer capsule 10 exerts force on the inner liner material so that the inner liner material fits tightly to the inner surface of the prosthetic receiving cavity. Since the heated inner liner material has good ductility, the outer surface shape of the inner liner matches the inner surface shape of the prosthetic receiving cavity. At the same time, the inner surface shape of the inner liner is the same as the inner surface shape of the prosthetic receiving cavity, which is also a shape that just matches the shape of the residual limb. After molding, the finished inner liner product is obtained.
[0044] In the whole process, the forming device plays a role in shaping the inner sleeve. Since the forming device itself is made of elastic-plastic material that is easy to deform, it produces bulging through filling. Since it has no fixed shape, it can adapt to any shape of the prosthetic receiving cavity to shape the inner sleeve raw material.
[0045] By using the inner sleeve molding device of the present invention to implement the process, only one set of molding devices is needed to adapt to the production of inner sleeves of various shapes, and there is no need to customize plaster molds according to each different residual limb shape, which directly saves the high production cost, transportation cost, storage cost, scrapping cost, and cleaning cost of the previous plaster molds, reduces waste, greatly reduces the manufacturing cost of the inner sleeve, and greatly improves production efficiency and production benefits. At the same time, because the molding device can be used multiple times, it has the advantage of being green and environmentally friendly; in addition, when the patient needs to replace the inner sleeve due to residual limb atrophy or the inner sleeve being contaminated, the molding device and molding process can facilitate the secondary production of the inner sleeve without the need for additional molds, which brings great convenience to the patient.
[0046] Preferably, an adjustment step may be included before the filling and molding steps.
[0047] As the residual limb of the patient tends to shrink gradually over time, the shape of the residual limb changes, resulting in the residual limb shape and the inner sleeve gradually not fitting well, and at this time the thickness of the inner sleeve needs to be increased, and there is a need to replace the inner sleeve; in addition, after a long period of use, the inner sleeve easily absorbs sweat, resulting in unsatisfactory hygiene of the inner sleeve, or when the inner sleeve is contaminated by other factors, the inner sleeve also needs to be replaced. The new inner sleeve must match the new residual limb shape, so when the inner sleeve is made for the second time, its size needs to be adjusted according to the patient's latest residual limb size.
[0048] The adjustment steps are as follows: according to the specific size of the residual limb of the patient, the stretch rope 60 is pulled downward and fixed to reduce the length of the outer bladder 10 (the outer bladder 10 can also be expanded after filling), thereby adjusting the size of the filling space 30 to adapt to the specific size of the residual limb of the patient. Specifically, by pulling the stretch rope to reduce the filling space 30, the thickness of the inner liner can be increased to adapt to the size of the residual limb of the patient after atrophy.
[0049] Preferably, the prosthetic receiving cavity manufacturing step is specifically a 3D printing step, in which a residual limb contour model is produced by a three-dimensional scanning device; based on the residual limb contour three-dimensional model, the residual limb contour three-dimensional module is digitally reshaped according to the prosthetic shaping principle and computer-aided software, and a three-dimensional model of the inner surface curved surface of the prosthetic receiving cavity is established; based on the inner surface curved surface three-dimensional model, a three-dimensional model of the prosthetic receiving cavity with a solid thickness is established; and 3D printing and molding are performed according to the three-dimensional model of the prosthetic receiving cavity to obtain a finished product of the prosthetic receiving cavity.
[0050] In the field of prosthetics, three-dimensional scanning and 3D printing methods are known technologies. For details, please refer to the Chinese invention application number CN201910485877.7.
[0051] Preferably, in the heating step, the heating temperature is preferably 60°C to 100°C.
[0052] Preferably, the inner liner is made of any one of EVA, polyurethane, silicone grease and gel grease.
[0053] Preferably, in the filling step: air is selected as the filling material, the filling nozzle 40 is opened, and the filling nozzle 40 is pressurized and inflated.
[0054] The above-mentioned embodiments are only preferred embodiments of the present invention and cannot be used to limit the scope of protection of the present invention. Any non-substantial changes and substitutions made by technicians in this field on the basis of the present invention shall fall within the scope of protection required by the present invention.
Claims
1. An inner liner forming device, characterized in that: include: The outer capsule and base; The outer sac is made of an elastic-plastic material that is easily deformed. The bottom of the outer sac is circumferentially fixedly connected to the base, and a filling space for accommodating filling material is formed between the outer sac and the base. An openable and closable filling nozzle is provided at the bottom of the base, and the filling nozzle is communicated with the filling space. The inner liner forming device also includes an inner bladder body and a stretching rope; the inner bladder body is made of an elastic-plastic material that is easy to deform and is arranged inside the outer bladder body. The base is also provided with a stretching through hole, and the bottom of the inner bladder body is circumferentially fixedly connected to the side of the stretching through hole; the upper surface of the top of the inner bladder body is fixedly connected to the lower surface of the top of the outer bladder body; one end of the stretching rope is fixedly connected to the lower surface of the top of the inner bladder body, and the other end passes through and extends out of the stretching through hole; The material of the inner capsule is any one of silica gel and rubber; The material of the outer capsule is any one of silicone and rubber; The filling material is any one of air and sand; Inner sleeve forming process of inner sleeve forming device The method comprises the following steps: a prosthetic receiving cavity taking step: making a new prosthetic receiving cavity according to the shape of the residual limb of the patient; or directly taking an existing old prosthetic receiving cavity; a step of placing inner liner raw material: taking the inner liner raw material according to the thickness and volume requirements of the inner liner, and placing the inner liner raw material into the prosthetic receiving cavity; a heating step: heating the inner liner raw material so that the inner liner raw material is heated to have good ductility; a filling and extrusion molding step: placing the inner liner molding device into the prosthetic receiving cavity so that the inner liner raw material is located between the prosthetic receiving cavity and the inner liner molding device; Open the filling nozzle, fill the interior of the outer balloon to make the outer balloon swell, and the outer balloon applies force to the inner liner material to tightly press the inner liner material into the prosthesis receiving cavity, so that the outer surface of the inner liner matches the inner surface of the prosthesis receiving cavity, and the inner surface shape of the inner liner is consistent with the inner surface shape of the prosthesis receiving cavity; Cooling and molding step: opening the filling nozzle to allow the filling material to leak out, taking out the inner liner molding device, and after the inner liner raw material is cooled and molded, obtaining the inner liner finished product, and taking it out; The step of obtaining the prosthetic receiving cavity is a 3D printing step: producing a residual limb contour model by a 3D scanning device; digitally shaping the residual limb contour 3D module according to the residual limb contour 3D model, according to the prosthetic shaping principle and computer-aided software, establishing a 3D model of the inner surface curved surface of the prosthetic receiving cavity; establishing a 3D model of the prosthetic receiving cavity with a solid thickness according to the inner surface curved surface 3D model; performing 3D printing and molding according to the prosthetic receiving cavity 3D model to obtain the finished product of the prosthetic receiving cavity.
2. The inner sleeve forming device according to claim 1, characterized in that: Before the filling and extrusion molding steps, an adjustment step is also included: according to the specific size of the patient's residual limb, the stretch rope is pulled downward and fixed to reduce the length of the outer balloon, thereby adjusting the size of the filling space to adapt to the specific size of the patient's residual limb.
3. The inner sleeve forming device according to claim 1, characterized in that: In the heating step, the heating temperature is 60°C to 100°C.
4. The inner liner forming device according to claim 1, characterized in that: The inner liner sleeve is made of any one of EVA, polyurethane, silicone grease and gel grease.
