CN112706345A

CN112706345A - Inner bushing forming device and inner bushing forming process

Info

Publication number: CN112706345A
Application number: CN202011438092.3A
Authority: CN
Inventors: 练志坚; 劳永华; 崔耀鹏
Original assignee: Heyi Shide Foshan Technology Co ltd
Current assignee: Foshan Gongqiao Medical Equipment Co ltd
Priority date: 2020-12-07
Filing date: 2020-12-07
Publication date: 2021-04-27

Abstract

The invention discloses an inner bushing forming device, which comprises: an outer bladder and a base; the outer bag body is made of elastic plastic materials which are easy to deform, the bottom of the outer bag body is fixedly connected to the base in the circumferential direction, and a filling space capable of containing filling materials is formed between the outer bag body and the base; the bottom of the base is provided with an openable filling nozzle which is communicated with the filling space. The invention also discloses an inner bushing forming process, which comprises the following steps: taking a prosthetic socket; putting the inner lining raw material; a heating step; filling and extrusion molding; and (5) cooling and forming. By adopting the inner liner forming device to implement the process, only one set of forming device is needed to adapt to the manufacture of inner liners with different shapes, and a plaster mold does not need to be customized according to each different stump shape, so that the cost is saved, the environment is protected, and the secondary manufacture and the replacement of the inner liner are convenient.

Description

Inner bushing forming device and inner bushing forming process

Technical Field

The invention relates to the field of artificial limbs, in particular to an inner bushing forming device and an inner bushing forming process using the forming device.

Background

The prosthesis inner liner is a link between the residual limb and the prosthesis socket, which is the most important position in the prosthesis, and has the functions of being installed in the prosthesis and buffering the stress. These functional effects are achieved by stimulating the skin and muscle tissue of the stump, which can cause discomfort and even injury to the amputee if not properly treated.

At present, the molding process of the inner bushing is roughly as follows:

taking a mould from the stump of the patient in a plaster bandage manner to manufacture a plaster female mould, wherein the shape of the plaster female mould is matched with that of the stump;

injecting gypsum slurry into the inner cavity of the gypsum female die, solidifying the slurry to obtain a gypsum male die, taking out the gypsum male die, and shaping the gypsum male die, wherein the shape of the gypsum male die is consistent with that of the stump;

rolling the lining sleeve material into a cone-like shape, sleeving the lining sleeve material outside the gypsum male mold, heating, sealing the lining sleeve material by using a plastic sleeve, vacuumizing the plastic sleeve, and extending and molding the material to be completely attached to the gypsum male mold; after cooling, taking out the finished inner bushing, wherein the inner cavity of the inner bushing is completely matched with the plaster male die, namely the shape of the stump of the patient.

After the inner bushing is manufactured, a prosthetic socket is manufactured according to the shape of the inner bushing (the shape of the prosthetic socket is matched with that of the inner bushing, the prosthetic socket is a shell part of an artificial limb, the manufacturing process mainly comprises the steps of sleeving a plastic bag on the outer surface of the inner bushing, injecting materials and grouting, sleeving a plastic bag on the outer surface, and curing to obtain the outer bushing prosthetic socket). The inner lining is put into the artificial limb receiving cavity for use.

In summary, the idea and sequence of the existing prosthesis forming process are roughly as follows: based on the shape of the stump, a plaster mold, an inner liner and a receiving cavity are manufactured. However, because the shape of the stump of each patient is different, and the inner liner is tailored to the individual condition of the patient, a plaster mold is determined to be made for each inner liner, and the plaster mold needs to be broken and discarded after the inner liner is made.

The prior art has great defects: (1) the manufacturing of the plaster mold needs to cost, the placement occupies extremely large space, and the plaster is a fragile product and needs to be carefully stored; (2) each gypsum mold can be scrapped only once, so that great waste is caused, the production cost is difficult to compress, and the gypsum mold is not environment-friendly and can not be recycled; (3) the scrapping of the gypsum mould is time-consuming and labor-consuming, and after the gypsum mould is smashed, the broken pieces need to be cleaned and carried away, so that the cost of garbage disposal is very high; (4) when the patient needs to replace the inner bushing due to atrophy of the stump or fouling of the inner bushing, the plaster mold needs to be manufactured again, which is very troublesome.

Disclosure of Invention

In order to overcome the defects of the prior art, the invention provides an inner bushing forming device, which can solve the problem that a plaster mold is required for forming the inner bushing in the prior art; the second purpose of the present invention is to provide an inner bushing forming process applied to the inner bushing forming apparatus, which can solve the problems of high production cost, high inner bushing replacement cost, high treatment cost, environmental pollution and troublesome process caused by the necessity of manufacturing a plaster mold and manufacturing an inner bushing.

The invention is realized by adopting the following technical scheme:

an inner liner molding apparatus, comprising: an outer bladder and a base; the outer bag body is made of elastic plastic materials which are easy to deform, the bottom of the outer bag body is circumferentially and fixedly connected to the base, and a filling space capable of containing filling materials is formed between the outer bag body and the base; the bottom of the base is provided with an openable filling nozzle, and the filling nozzle is communicated with the filling space.

Further, the inner liner forming device also comprises an inner bag body and a tensile rope; the inner bag body is made of elastic plastic materials which are easy to deform and is arranged inside the outer bag body, the base is also provided with a stretching through hole, and the bottom of the inner bag body is circumferentially and fixedly connected to the side part of the stretching through hole; the upper surface of the top end of the inner bag body is fixedly connected with the lower surface of the top end of the outer bag body; one end of the stretching rope is fixedly connected with the lower surface of the top end of the inner bag body, and the other end of the stretching rope penetrates through the stretching through hole and extends out of the stretching through hole.

Further, the material of the outer bag body is any one of silica gel and rubber.

Further, the material of the inner bag body is any one of silica gel and rubber.

Further, the filling material is any one of air and sand.

An inner liner molding process applied to the inner liner molding apparatus, characterized by comprising the steps of: taking a prosthetic socket: manufacturing a new artificial limb receiving cavity according to the shape of the residual limb of the patient; or directly taking the existing old prosthetic socket; putting the inner lining raw materials: taking an inner lining raw material according to the required thickness and volume requirements of the inner lining, and placing the inner lining raw material into the artificial limb receiving cavity; a heating step: heating the inner lining raw material to ensure that the inner lining raw material is heated to have good ductility; filling and extrusion molding: placing the inner liner forming device into the artificial limb receiving cavity, and enabling the inner liner raw material to be located between the artificial limb receiving cavity and the inner liner forming device; opening the filling nozzle, filling the interior of the outer bag body to expand the outer bag body, applying acting force on the inner lining raw material by the outer bag body, tightly pressing the inner lining raw material in the artificial limb receiving cavity to enable the outer surface of the inner lining to be matched with the inner surface of the artificial limb receiving cavity, and enabling the shape of the inner surface of the inner lining to be consistent with the shape of the inner surface of the artificial limb receiving cavity; and (3) cooling and forming: and opening the filling nozzle to discharge the filling material, taking out the inner bushing forming device, cooling and forming the inner bushing raw material to obtain an inner bushing finished product, and taking out the inner bushing finished product.

Further, before the filling and extrusion molding step, the method further comprises an adjusting step: and according to the specific size of the patient residual limb, pulling and fixing the stretching rope downwards to reduce the length size of the outer bag body, so that the size of the filling space is adjusted to adapt to the specific size of the patient residual limb.

Further, the prosthesis socket taking step is a 3D printing step: producing a residual limb contour model through three-dimensional scanning equipment; according to the three-dimensional model of the profile of the residual limb, digitally modifying the three-dimensional module of the profile of the residual limb according to an artificial limb modification principle and computer-aided software, establishing a three-dimensional model of an inner surface curved sheet of the artificial limb socket, and establishing the three-dimensional model of the artificial limb socket with the solid thickness according to the three-dimensional model of the inner surface curved sheet; and 3D printing, processing and forming are carried out according to the three-dimensional model of the prosthetic socket to obtain a finished product of the prosthetic socket.

Further, in the heating step, the heating temperature is 60 ℃ to 100 ℃.

Furthermore, the inner lining raw material is any one of EVA, polyurethane, silicone grease and coagulated grease.

Compared with the prior art, the invention can achieve the following beneficial effects:

the inner liner forming process adopts a process method completely different from the prior art, firstly, a new artificial limb receiving cavity can be manufactured according to the shape of the residual limb of a patient, or an old artificial limb receiving cavity which is already manufactured (the shape of the artificial limb receiving cavity is matched with the shape of the residual limb), then, the inner liner raw material is put into the artificial limb receiving cavity, after the artificial limb receiving cavity is heated to a proper temperature, the inner liner forming device is put into the receiving cavity for filling, and the outer sac body is expanded. Because the inner liner forming device itself is not shaped, after inflation, the shape of the outer bladder is constrained by the inner surface of the prosthetic socket cavity, which is shaped to conform to the shape of the residual limb. In the process, the outer capsule applies acting force to the inner lining raw material to enable the inner lining raw material to be tightly attached to the inner surface of the artificial limb receiving cavity, the heated inner lining raw material has good ductility, so that the shape of the outer surface of the inner lining is matched with the shape of the inner surface of the artificial limb receiving cavity, meanwhile, the shape of the inner surface of the inner lining is the same as the shape of the inner surface of the artificial limb receiving cavity, and is also exactly matched with the shape of a residual limb, and a finished product of the inner lining is obtained after forming.

In the whole process flow, the forming device plays a role in sizing the inner bushing. Because the forming device is made of elastic plastic materials which are easy to deform, the forming device generates bulging through filling, and the forming device has no definite shape and can adapt to artificial limb receiving cavities with any shape to form the inner lining raw materials.

By adopting the inner bushing forming device to implement the process, only one set of forming device is needed to adapt to the manufacture of inner bushings in various shapes, a plaster mold is not needed to be customized according to each different stump shape, the high manufacturing cost, transportation cost, storage cost, scrapping cost and cleaning cost of the traditional plaster mold are directly saved, the waste is reduced, the manufacturing cost of the inner bushing is greatly reduced, and the production efficiency and the production benefit are greatly improved. Meanwhile, the forming device can be used for multiple times, so that the forming device has the advantages of environmental protection; in addition, when the patient needs to replace the inner bushing due to the reason that the residual limb is atrophied or the inner bushing is polluted and the like, the forming device and the forming process can be used for conveniently carrying out secondary manufacturing on the inner bushing, and the mold opening is not needed, so that great convenience is brought to the patient.

Drawings

FIG. 1 is a front sectional view of an inner liner forming apparatus;

FIG. 2 is a side cross-sectional view of an inner liner forming apparatus;

FIG. 3 is a cross-sectional view of the inner liner forming apparatus in a tension adjustment state;

FIG. 4 is a flow chart illustrating the inner liner forming process.

In the figure: 10. an outer bladder body; 20. a base; 21. stretching the through hole; 30. filling the space; 40. a filling nozzle; 50. an inner bladder body; 60. and (6) stretching the rope.

Detailed Description

The present invention will be further described with reference to the accompanying drawings and the detailed description, and it should be noted that any combination of the embodiments or technical features described below can be used to form a new embodiment without conflict.

Referring to fig. 1-3, the present invention discloses an inner liner forming device, which comprises an outer bag body 10 and a base 20. Wherein, the outer bag 10 is made of elastic plastic material which is easy to deform, the bottom of the outer bag 10 is circumferentially and fixedly connected to the base 20, more specifically, the bottom of the outer bag 10 is sleeved outside the base 20, so that a filling space 30 which can contain filling material is formed between the outer bag 10 and the base 20; the bottom of the base 20 is opened with a freely openable and closable filling nozzle 40, one end of the filling nozzle 40 is communicated with the filling space 30, and the other end extends out of the lower part of the base 20. When there is no contents in the filling space 30, the outer bag 10 is collapsed, and when a filler is injected into the filling space 30 through the filling nozzle 40, the outer bag 10 is inflated, and its specific shape is changed according to external restrictions. For example, when the forming device is placed in a hemispherical prosthetic socket and the balloon is inflated after filling, the outer bladder 10 with good plasticity is limited by the hemispherical shape, and the outer bladder 10 is adapted to form a hemisphere; the other shapes are the same.

Preferably, the inner liner forming device further comprises an inner bladder 50 and a tensile cord 60. The inner bag body 50 is also made of an elastic plastic material which is easy to deform and is arranged inside the outer bag body 10, the base 20 is further provided with a stretching through hole 21, and the bottom of the inner bag body 50 is circumferentially and fixedly connected to the side part of the stretching through hole 21. The upper surface of the top end of the inner bag 50 is fixedly connected with the lower surface of the top end of the outer bag 10, it should be noted that the inner bag 50 and the outer bag 10 are fixedly connected only through one end point, and not the whole outer surface of the inner bag 50 and the whole inner surface of the outer bag 10 are completely bonded. One end of the stretching rope 60 is fixedly connected with the lower surface of the top end of the inner bag body 50, and the other end thereof penetrates through the stretching through hole 21 and extends out of the stretching through hole.

In the case of the inner bladder 50, the filling space 30 is actually the size of the cavity formed between the inner bladder 50 and the outer bladder 10. When the tensile rope 60 is pulled downwards, the inner bag body 50 drives the top end of the outer bag body 10 to move downwards, the tensile rope 60 is fixed again, the size of the filling space 30 is compressed, and the size adjustment of the forming device is realized through the tensile rope 60 and the inner bag body 50.

Preferably, the material of the outer capsule 10 may be any one of silicone rubber and rubber, and may also be other known materials with good heat resistance and elastic-plastic property; preferably, the material of the inner bag 50 may be any one of silicone rubber and rubber, or other known materials with good heat resistance and elastic-plastic property.

Preferably, the filling material may be any one of air and sand, and may be other known materials which are strong in plasticity and easy to fill. In the present invention, the filling material is preferably air, and the air is directly injected into or discharged from the outer bag body 10, which is convenient and fast and saves cost.

Specifically, the filling nozzle 40 is embodied as a valve, and the valve is communicated with the filling space 30.

The invention also discloses an inner bushing forming process applied to the inner bushing forming device, which at least comprises the following steps with reference to fig. 4:

taking a prosthetic socket: manufacturing a new artificial limb receiving cavity according to the shape of the residual limb of the patient; or directly taking the existing old prosthetic socket; specifically, a new prosthetic socket can be manufactured for a patient by adopting the existing method, or an old prosthetic socket in use of the patient can be directly taken out, and the inner lining raw material is put into the step: taking an inner lining raw material according to the required thickness and volume requirements of an inner lining, and placing the inner lining raw material into the artificial limb receiving cavity, more specifically, the inner lining raw material can be well attached to the inner surface of the artificial limb receiving cavity during placement so as to facilitate subsequent extrusion forming;

a pressurizing step: heating the inner lining raw material to enable the inner lining raw material to be heated so as to have good ductility;

filling and extrusion molding: discharging the filling material in the inner liner forming device, and placing the inner liner forming device into the artificial limb receiving cavity to enable the inner liner raw material to be positioned between the artificial limb receiving cavity and the inner liner forming device; opening the filling nozzle 40, filling the inner part of the outer bag body 10 to enable the outer bag body 10 to swell, applying acting force on the inner lining raw material by the swelled outer bag body 10, and tightly pressing the inner lining raw material on the inner surface of the prosthetic socket; because the inner lining raw material has good ductility, after the pressing, the outer surface of the inner lining is matched with the inner surface of the artificial limb receiving cavity, meanwhile, because the inner lining forming device exerts acting force on all parts of the inner lining raw material, the thicknesses of all parts of the inner lining are basically close to the same, and the shape of the inner surface of the inner lining is consistent with that of the inner surface of the artificial limb receiving cavity, namely, is matched with the shape of the stump of a patient;

and (3) cooling and forming: and opening the filling nozzle 40 to discharge the filling material, taking out the inner bushing forming device, cooling and forming the inner bushing raw material to obtain an inner bushing finished product, and taking out the inner bushing finished product.

The technical effect that the process method disclosed by the invention can achieve is as follows: the inner liner forming process adopts a process method completely different from the prior art, firstly, a prosthetic socket is taken, a new prosthetic socket can be manufactured according to the shape of the residual limb of a patient, or an old prosthetic socket which is already manufactured (the shape of the prosthetic socket is matched with the shape of the residual limb), then the raw material of the inner liner is put into the prosthetic socket, after the inner liner is heated to a proper temperature, the inner liner forming device is put into the socket for filling, and the outer bag body 10 is expanded. Since the inner liner forming means itself is not positively shaped, the shape of the outer bladder 10 is constrained by the inner surface of the prosthetic socket cavity after inflation, which is shaped to conform to the shape of the residual limb. In the process, the outer bag body 10 applies acting force to the inner lining raw material to enable the inner lining raw material to be tightly attached to the inner surface of the artificial limb receiving cavity, the outer surface shape of the inner lining is matched with the inner surface shape of the artificial limb receiving cavity due to the good ductility of the heated inner lining raw material, meanwhile, the inner surface shape of the inner lining is the same as the inner surface shape of the artificial limb receiving cavity and is also exactly matched with the shape of the stump, and the finished product of the inner lining is obtained after forming.

Preferably, before the filling and forming steps, an adjustment step may also be included.

Because the stump of a patient is easy to gradually shrink along with time, the shape of the stump is changed, so that the shape of the stump is gradually not attached to the inner liner, the thickness of the inner liner needs to be increased, and the inner liner needs to be replaced; in addition, after a long period of use, the inner liner tends to absorb sweat, which results in undesirable sanitary conditions of the inner liner, or the inner liner needs to be replaced when it is contaminated by other contaminants. The new inner liner must match the new residual limb shape, so when the inner liner is manufactured twice, its size needs to be adjusted according to the latest residual limb size of the patient.

The adjusting steps are as follows: the tensile cord 60 is pulled and fixed downward according to the specific size of the stump of the patient, so that the length of the outer bladder 10 is reduced (the outer bladder 10 can be inflated as well) and the size of the filling space 30 is adjusted to fit the specific size of the stump of the patient. Specifically, by pulling the tensile cord to reduce the fill space 30, the inner liner can be made thicker to accommodate the size of the stump after atrophy.

Preferably, the artificial limb socket manufacturing step is a 3D printing step, and a residual limb contour model is produced through three-dimensional scanning equipment; according to the three-dimensional model of the profile of the residual limb, digitally modifying the three-dimensional module of the profile of the residual limb according to an artificial limb modification principle and computer-aided software, establishing a three-dimensional model of an inner surface curved sheet of the artificial limb socket, and establishing the three-dimensional model of the artificial limb socket with the solid thickness according to the three-dimensional model of the inner surface curved sheet; and 3D printing, processing and forming according to the three-dimensional model of the prosthetic socket to obtain a finished product of the prosthetic socket.

In the field of artificial limb production, three-dimensional scanning and 3D printing methods are known, and refer to chinese invention with application number CN 201910485877.7.

Preferably, in the heating step, the heating temperature is preferably 60 ℃ to 100 ℃.

Preferably, the inner lining raw material adopts any one of EVA, polyurethane, silicone grease and coagulated grease.

Preferably, in the filling step: the filling material is air, the filling nozzle 40 is opened, and the filling nozzle 40 is pressurized and inflated.

The above embodiments are only preferred embodiments of the present invention, and the protection scope of the present invention is not limited thereby, and any insubstantial changes and substitutions made by those skilled in the art based on the present invention are within the protection scope of the present invention.

Claims

1. An inner liner forming apparatus, comprising: an outer bladder and a base; the outer bag body is made of elastic plastic materials which are easy to deform, the bottom of the outer bag body is circumferentially and fixedly connected to the base, and a filling space capable of containing filling materials is formed between the outer bag body and the base; the bottom of the base is provided with an openable filling nozzle, and the filling nozzle is communicated with the filling space.

2. The interlining forming device of claim 1, further comprising an inner bladder and a tensile cord; the inner bag body is made of elastic plastic materials which are easy to deform and is arranged inside the outer bag body, the base is also provided with a stretching through hole, and the bottom of the inner bag body is circumferentially and fixedly connected to the side part of the stretching through hole; the upper surface of the top end of the inner bag body is fixedly connected with the lower surface of the top end of the outer bag body; one end of the stretching rope is fixedly connected with the lower surface of the top end of the inner bag body, and the other end of the stretching rope penetrates through the stretching through hole and extends out of the stretching through hole.

3. The inner liner molding apparatus as claimed in claim 1, wherein the material of the outer bladder is any one of silicone rubber and rubber.

4. The inner liner molding apparatus as claimed in claim 2, wherein the material of the inner bladder is any one of silicone and rubber.

5. The inner liner molding apparatus as claimed in claim 1, wherein the filling material is any one of air and sand.

6. An inner liner forming process applied to the inner liner forming device according to any one of claims 1 to 5, characterized by comprising the following steps:

taking a prosthetic socket: manufacturing a new artificial limb receiving cavity according to the shape of the residual limb of the patient; or directly taking the existing old prosthetic socket;

putting the inner lining raw materials: taking an inner lining raw material according to the required thickness and volume requirements of the inner lining, and placing the inner lining raw material into the artificial limb receiving cavity;

a heating step: heating the inner lining raw material to ensure that the inner lining raw material is heated to have good ductility;

filling and extrusion molding: placing the inner liner forming device of any one of claims 1 to 5 into the prosthetic socket with the inner liner feedstock between the prosthetic socket and the inner liner forming device; opening the filling nozzle, filling the interior of the outer bag body to expand the outer bag body, applying acting force on the inner lining raw material by the outer bag body, tightly pressing the inner lining raw material in the artificial limb receiving cavity to enable the outer surface of the inner lining to be matched with the inner surface of the artificial limb receiving cavity, and enabling the shape of the inner surface of the inner lining to be consistent with the shape of the inner surface of the artificial limb receiving cavity;

and (3) cooling and forming: and opening the filling nozzle to discharge the filling material, taking out the inner bushing forming device, cooling and forming the inner bushing raw material to obtain an inner bushing finished product, and taking out the inner bushing finished product.

7. The inner liner molding process as claimed in claim 6, further comprising, before the filling and extruding step, an adjusting step of: and according to the specific size of the patient residual limb, pulling and fixing the stretching rope downwards to reduce the length size of the outer bag body, so that the size of the filling space is adjusted to adapt to the specific size of the patient residual limb.

8. The inner liner molding process of claim 6, wherein the prosthetic socket taking step is a 3D printing step: producing a residual limb contour model through three-dimensional scanning equipment; according to the three-dimensional model of the profile of the residual limb, digitally modifying the three-dimensional module of the profile of the residual limb according to an artificial limb modification principle and computer-aided software, establishing a three-dimensional model of an inner surface curved sheet of the artificial limb socket, and establishing the three-dimensional model of the artificial limb socket with the solid thickness according to the three-dimensional model of the inner surface curved sheet; and 3D printing, processing and forming are carried out according to the three-dimensional model of the prosthetic socket to obtain a finished product of the prosthetic socket.

9. The inner liner molding process according to claim 6, wherein in the heating step, the heating temperature is 60 ℃ to 100 ℃.

10. The inner liner molding process according to claim 6, wherein the inner liner is made of any one of EVA, polyurethane, silicone grease, and coagulated grease.