JP2007289680A - Socket liner for artificial limb and its manufacturing method - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a socket liner for an artificial limb capable of enhancing the adaptability to the limbs and reduced in cost. <P>SOLUTION: Paste 11 is compounded with a rubber latex 12 to prepare a compounded liquid 13, and air is mixed with the compounded liquid 13 to prepare an air mixed liquid 16. A gelling agent 17 is charged in the air mixed liquid 16 under stirring to prepare a raw liquid 18 which is, in turn, is charged in the cavity of the mold of a molding machine to produce a socket liner original shape 26. The socket liner original shape 26 is vulcanized to produce the socket liner. Since the socket liner has air permeability and the hardness, repulsive elasticity and tensile strength thereof also become a proper range and the adaptability to the limbs can be enhanced. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to a prosthetic socket liner used inside a prosthetic socket that supports a stump formed by illness or an accident on the leg of a human body, and a method of manufacturing the same.

  The socket liner for prosthetic limbs is required to have appropriate rebound resilience in order to mitigate the compatibility with the stumps of the extremities of the human body and the impact from the outside. As this socket liner, a socket socket made of silicone is disclosed in paragraph 0003 of the publication of Patent Document 1. Since this socket liner is not air permeable, there are problems that the limbs sweat, the user feels uncomfortable, the skin becomes inflamed, and the skin becomes weak.

In order to solve the above problem, the invention described in Patent Document 1 proposes a method for manufacturing a custom-molded liner with good air permeability for a prosthetic socket. That is, the method of manufacturing the liner includes providing a liner comprising an open cell foam material impregnated with a curable resin, activating the foam material, and until the curing is substantially complete. The limb remaining on the opposite first surface is disposed, and the prosthetic limb socket is disposed on the opposite second surface of the liner, thereby deforming the foam material and remaining in the foam material. Generating and maintaining the impressions.
JP 2001-518350 A paragraph number 0003

  However, the socket liner manufacturing method described above can form a liner that fits the limb, but has a relatively complicated structure and a large number of manufacturing steps. Also, because the foam material is impregnated with a curable resin, it is difficult to properly control physical properties such as breathability and rebound resilience of the finished product even if the number and size of cells of the foam material are controlled. was there. Furthermore, there has been a problem that no measures have been taken to improve the feel when the limb contacts the socket liner, so-called touch.

  An object of the present invention is to provide a socket liner for a prosthetic limb that can solve the above-mentioned conventional problems and improve the adaptability to the limb, and a manufacturing method thereof.

  In order to solve the above-mentioned problems, the invention according to claim 1 is a prosthetic socket comprising a rubber latex foam made of at least one of isoprene rubber, chloroprene rubber and deproteinized natural rubber. The gist of the liner is that the air permeability based on JIS standard P8117 is set to 10 to 30 seconds.

  The invention according to claim 2 is characterized in that, in claim 1, the tensile strength based on JIS standard K6251 is 0.4 to 2.0 MPa, and the tear strength by the non-cut angle type test piece based on JIS standard K6252 is 2.0. The gist is that it is set to ˜10.0 N / mm.

The gist of the invention of claim 3 is that, in claim 1 or 2, the rubber latex foam is made of isoprene rubber.
The gist of the invention described in claim 4 is that, in any one of claims 1 to 3, the surface of the prosthetic socket liner is subjected to a slip treatment.

  The invention according to claim 5 includes a step of blending a rubber latex with a paste to produce a blended solution, a step of stirring the blended solution and blowing air into the blended solution to produce an air mixture, and the air A step of producing a stock solution for producing a prosthetic socket liner by mixing a gelling agent into the mixed solution, a step of injecting the stock solution into a mold to form a prosthetic socket liner prototype, and the prosthetic socket liner And a vulcanization step of producing a socket liner for a prosthetic limb by vulcanizing the original form using a vulcanizer.

  According to the invention according to any one of claims 1 to 4, the prosthetic socket liner is made of a rubber latex foam, and the air permeability based on JIS standard P8117 is set to 10 to 30 seconds. With the prosthetic socket liner attached to the limb, heat generated from the limb is dissipated through the prosthetic socket liner, preventing the limbs from being steamed and improving adaptability to the limb. Further, the prosthetic socket liner can absorb the impact and protect the limb appropriately when the limb is strongly pressed against the prosthetic socket liner.

  According to the fifth aspect of the present invention, in the step of manufacturing the stock solution for manufacturing the socket liner for prosthetic limbs, the water passage is formed when the water inside the rubber is released to the outside, and this becomes an infinite number of bubbles. Since it is formed vertically and horizontally as an infinite number of communicating passages, the restriction condition of adjustment of the amount of air to form bubbles and the timing of gelation of rubber is relaxed, and it becomes easy to obtain appropriate air permeability. . Therefore, physical properties such as air permeability of the prosthetic socket liner can be easily controlled as compared with other polyurethane foams and the like.

Hereinafter, an embodiment in which the socket liner for prosthetic limbs of the present invention is embodied will be described with reference to the drawings.
First, a method for manufacturing a prosthetic socket liner using isoprene rubber (IR) will be described.

  As shown in step S1 of FIG. 1, various compounding agents such as a cross-linking agent, a vulcanization accelerator, a pigment, and an antibacterial agent for paste production are weighed using a measuring instrument. Specifically, when 100 parts by mass of isoprene rubber is used, 1.5 parts by mass of sulfur as a crosslinking agent, 1 part by mass of thiurams as a vulcanization accelerator, or 5 parts by mass of zinc oxide, a pigment and an antibacterial agent If necessary, mass parts are appropriately added. A paste 11 is manufactured by storing various measured ingredients and water in a ball mill (not shown) at a mass ratio of 1: 1 and stirring and kneading.

  Next, in step S2 of FIG. 1, for example, a 1-liter volume of isoprene rubber (IR) latex 12 prepared in advance and 10 to 20 milliliters of the paste 11 are contained in a container (not shown) and blended. The blended liquid 13 is produced by aging for a time (for example, 12 to 24 hours).

  In step S3 of FIG. 1, a predetermined amount (for example, 250 milliliters) of the above-mentioned mixed solution 13 required for one prosthetic limb liner is measured, and this measured mixed solution 13 is stored in the stirring container 14 of the stirring device shown in FIG. Then, the pair of stirring rods 15 are stirred at a high speed so that air is mixed into the compounded liquid 13 to produce an air mixed liquid 16. In this step, the volume of the air mixture 16 is approximately twice (500 ml) of the volume of the blended liquid 13 (250 ml).

  Thereafter, in step S4 of FIG. 1, as shown in FIG. 3, a small amount of gelling agent 17 is introduced into the stirring vessel 14 containing the air mixed solution 16, and the stirring rod 15 is rotated at a rotational speed (for example, several hundred times / The gelling agent 17 is mixed into the air mixed solution 16 by rotating at a minute) to produce a stock solution 18 for forming a socket liner original shape.

  Next, in step S5 of FIG. 1, as shown in FIGS. 4 and 5, the stock solution 18 is placed in a cavity 24 formed by an inner mold 22 and an outer mold 23 standing on the base 21 of the molding apparatus. Is injected from an injection hole 23 a formed in the upper part of the outer mold 23. The outer mold 23 is fixed to the inner mold 22 by a plurality of (for example, six) bolts 25 screwed into a screw hole 23b formed at the lower end of the outer mold 23. Then, as shown in FIG. 5, the stock solution 18 filled in the cavity 24 is aged for a predetermined time (for example, 10 to 60 minutes) to manufacture the socket liner original 26.

  In step S6 of FIG. 1, as shown in FIG. 6, after removing the bolt 25 screwed into the screw hole 23b of the outer mold 23 of the molding apparatus, the outer mold 23 is moved upward from the inner mold 22 and the socket liner original pattern 26. The socket liner original 26 attached to the inner mold 22 is aged for a predetermined time (for example, 15 to 30 minutes). In this aging process, water contained in the socket liner original 26 is evaporated. The socket liner prototype 26 is accommodated in a vulcanizer 31 shown in FIG. 7, and the socket liner prototype 26 is vulcanized in a warm bath atmosphere using sulfur as a vulcanizing agent. Remove and cool.

  As shown in FIG. 8, in step S7 of FIG. 1, the socket liner original form 26 is removed from the inner mold 22 and removed from the mold. After cooling by natural cooling, the socket liner original form 26 is accommodated in a cleaning device (not shown). Residues such as soap are removed by washing with hot water and water, and the socket liner original form 26 is accommodated in a drying device (not shown) and dried to complete the manufacture of the socket liner original form 26 as a rubber latex foam.

  Finally, in step S8 of FIG. 1, the socket liner original form 26 is accommodated in the treatment tank 36 of the halogen processing apparatus as shown in FIG. 9, and the outer surface of the socket liner original form 26 is subjected to halogen treatment as a lubrication treatment. In this halogen treatment, a treatment solution 37 obtained by blending 15 parts by mass of hydrochloric acid and 30 parts by mass of sodium hypochlorite with respect to 100 parts by mass of water is used. The socket liner original pattern 26 is immersed in the processing solution 37 for a predetermined time (for example, 5 to 15 minutes), and a fine rough surface is formed on the outer surface of the socket liner original pattern 26.

  As shown in FIG. 10, the halogen liner socket liner original 26 is cut into a predetermined length according to the shape of the socket portion 42 of the prosthesis 41 and used as a prosthetic socket liner 43 as shown in FIG. 10. The thickness t1 of the cylindrical portion 43a of the socket liner 43 is set to 5 to 7 mm, for example, and the thickness t2 of the lower spherical portion 43b is set to 7 to 9 mm, for example. Moreover, the diameter d dimension of the cylindrical part 43a is set to 90-100 mm, for example. The socket liner 43 is tapered according to the size of the prosthesis 41 so that the upper opening side of the cylindrical portion 43a has a large diameter as shown by a two-dot chain line in FIG. Kinds are manufactured.

Next, the physical characteristics of the hardness, rebound resilience, air permeability, and tensile strength of the socket liner 43 manufactured by the above-described manufacturing method will be described.
(hardness)
A sample made of the same material as the socket liner 43, 300 mm long, 500 mm wide, and 7.5 mm thick was prepared. The hardness of the surface of the sample was measured using a type E durometer hardness meter based on JIS standard K6253 as a hardness meter. As a result of the measurement, the hardness of the surface of the sample was 10.8.
(Rebound resilience)
As a result of measuring the resilience elastic modulus with a measuring device of JIS standard K6400-3 using the same sample as the measurement of hardness, it was 37%.
(Breathability)
Breathability was measured with a measuring device of JIS standard P8117 using four samples of 300 mm in length and 500 mm in width and 5.0 mm in thickness made of the same material as the socket liner 43. Each sample is different in the amount of air mixed with the compounding liquid 13, the number of rotations of the stirrer, and the rotation time. The time for air to pass through the area 642 mm 2 of each sample was measured. As a result, it was found that each sample was different from 23 seconds, 12 seconds, 16 seconds, and 24 seconds. The average value was about 19 seconds. When the air permeability of the prosthetic socket liner 43 is improved, the tensile strength and the tear strength are reduced, and when the air permeability is deteriorated, stuffiness is caused in the use state.
(Tensile strength and tear strength)
Tensile stress was measured with a tensile strength measuring device of JIS standard K6272 using a sample of 300 mm in length and 500 mm in width and 5.0 mm in thickness made of the same material as the socket liner 43. As a result, as shown in the graph of FIG. 11, it was found that as the amount of strain of the sample increases, the increasing tendency of stress increases like a parabola.

  The tensile stress when the elongation percentage of the sample was 300% was 0.38 MPa, and the tensile stress when the elongation percentage was 880% was 1.65 MPa. The tear strength was 8.8 N / mm, and the width was 7.9 N / mm.

According to the prosthetic socket liner 43 of the above embodiment, the following effects can be obtained.
(1) In the said embodiment, the paste 11 is mix | blended with the latex 12 of isoprene rubber, the liquid mixture 13 is manufactured, the liquid mixture 13 is stirred at high speed with a stirrer, air is blown, and the air liquid mixture 16 is manufactured, and air The stock solution 18 was produced by adding the gelling agent 17 to the mixed solution 16 and stirring, and the stock solution 18 was poured into a molding die of a molding apparatus to mold the socket liner prototype 26. In the molding process of the socket liner original 26, the rubber is gelled while there are innumerable bubbles mixed in the original 26, and the water passage when the water inside the rubber is released to the outside. This passage is formed vertically and horizontally as an infinite number of passages communicating with the bubbles, and an appropriate air permeability is obtained in the original shape 26. Accordingly, among the physical characteristics of the socket liner 43, the air permeability of JIS standard P8117 is within a proper range (for example, 12 to 24 seconds). As shown in FIG. 10, in a state where the socket liner 43 is accommodated in the socket portion 42 of the prosthesis 40 and the prosthesis 41 is mounted in the socket liner 43, heat generated from the prosthesis 41 is dissipated through the socket liner 43. Steaming is prevented.

  (2) In the above embodiment, as described above, a moisture passage is formed when moisture inside the original 26 (rubber) is released to the outside, and this passage serves as an infinite number of passages communicating with countless bubbles. Since it is formed vertically and horizontally, the restriction condition of adjustment of the amount of air to form bubbles and the timing of gelation is relaxed, and it becomes easy to obtain appropriate air permeability. Therefore, in addition to the breathability of the prosthetic socket liner 43, physical properties such as rebound resilience, hardness and tensile strength can be easily controlled.

  (3) In the above embodiment, since the prosthetic socket liner 43 is formed by the latex foam of isoprene rubber, the touch is good and the limb allergy does not occur.

  (4) In the above embodiment, among the physical characteristics of the socket liner 43, the hardness of the type E durometer hardness tester based on JIS standard K6253 is in an appropriate range of 10 to 12, and the rebound elastic modulus of JIS standard K6400-3 is 37. It is an appropriate range of ˜63%. For this reason, a prosthetic socket liner 43 that is not insufficient in strength is manufactured at low cost, and when an external force acts on the socket liner 43 from the prosthetic limb 41 during walking, the impact is properly absorbed by the socket liner 43. Thus, the prosthetic limb 41 can be properly protected.

  (5) In the above embodiment, since the socket liner 43 is manufactured using latex of isoprene rubber, the material cost can be reduced as compared with the socket liner made of silicon.

  (6) In the above-described embodiment, a fine rough surface is formed on the outer surface of the socket liner 43 by halogen treatment to reduce the friction coefficient of the surface, so that the slip property is improved and the socket liner 43 against the socket portion 42 is improved. It is possible to easily perform the desorption operation.

  (7) In the above embodiment, since the socket liner 43 has the tensile strength characteristics shown in FIG. 11, when the socket liner 43 is attached to the prosthesis 41, the strain when the opening of the liner 43 is first expanded is 100. Since it is ˜300%, the stress is small, so that the socket liner 43 can be easily attached to the prosthesis 41.

In addition, you may change the said embodiment as follows.
-As rubber latex, in addition to isoprene rubber (IR) latex, at least one of chloroprene rubber latex and deproteinized natural rubber latex may be selected. The isoprene rubber latex, chloroprene rubber latex, and deproteinized natural rubber latex have better tensile strength and tear strength characteristics than nitrile rubber (NBR) latex, styrene butadiene rubber (SBR) latex, etc. Suitable for the material used. In addition, when natural rubber latex is used, there is no practical difference in physical properties depending on the presence or absence of deproteinization treatment, but in the case of natural rubber that has not undergone deproteinization treatment, tensile strength characteristics and tear strength characteristics However, it is not preferable because allergic symptoms due to the protein contained in the rubber may occur. Synthetic rubber isoprene rubber latex does not have an adverse effect on the human body, but contains chlorine, so there is a concern about the impact on the environment. The most preferable material from the viewpoint of the influence of the human body and the environment is isoprene rubber latex which is a synthetic rubber.

  Of the various types of rubber latex, for example, blending a plurality of types of rubber latex, such as mixing a deproteinized natural rubber latex and isoprene rubber latex, or mixing isoprene rubber latex and SBR latex, etc. It may be used.

  Of the various types of rubber latex, for example, blending a plurality of types of rubber latex, such as mixing a deproteinized natural rubber latex and isoprene rubber latex, or mixing isoprene rubber latex and SBR latex, etc. It may be used.

  The hardness of the physical properties of the socket liner 43 is set in the range of 5 to 40 when measured with a type E durometer hardness meter based on JIS standard K6253. When the hardness is 5 or less, the liner 43 is compressed by the tip portion of the prosthesis 41 during use and butts down, and when the hardness is 40 or more, it is too hard and the cushioning property is impaired. From the viewpoint of cushioning properties, the hardness is preferably 8 to 16, and more preferably 10 to 14.

  Of the physical characteristics of the socket liner 43, the rebound resilience is set in a range of 35 to 65% when measured using a measuring device of JIS standard K6400-3. If it is 35% or less, the liner 43 is compressed by the distal end portion of the prosthetic limb 41 during use and sticks to the bottom. Further, if it is 65% or more, the hardness is increased, which is not good.

  Of the physical characteristics of the socket liner 43, the air permeability is set in the range of 10 to 30 seconds when measured with a measuring device of JIS standard P8117. If it is longer than 30 seconds, the air permeability is poor, and stuffiness occurs during use. Also, if it is 10 seconds or less, the air permeability is improved, but it is not preferable because the tensile strength, tear strength, hardness and impact resilience are lowered.

  -The tensile strength based on K6251 of the JIS specification of the physical characteristic of the said socket liner 43 is set to the range of 0.4-2.0 MPa. Further, the tear strength of the angle type test piece without cut based on K6252 of JIS standard is set in the range of 2.2 to 10.0 N / mm on the average of the vertical length.

A silicon baking process may be performed instead of the halogen process as the lubrication process.
The socket liner 43 may be used as a soft liner for a temporary prosthesis.

  -You may make it adjust the air permeability of the socket liner 43 by adjusting the usage-amount of the gelatinizer 17. FIG.

The flowchart which shows the manufacturing method of the socket liner original form as a socket liner for artificial limbs of this invention. Explanatory drawing which shows the process of blowing air in a compounding liquid and manufacturing an air liquid mixture. Explanatory drawing which shows the process of mixing a gelatinizer in an air liquid mixture and manufacturing a stock solution. Sectional drawing which shows the formation process of a socket liner original form. Sectional drawing which shows the formation process of a socket liner original form. Sectional drawing which shows the formation process of a socket liner original form. Explanatory drawing which shows the vulcanization process of a socket liner original form. Sectional drawing which shows the process of demolding an inner type | mold from a socket liner original form. Sectional drawing which shows the halogen treatment process of a socket liner. Sectional drawing which shows the use condition of a socket liner. The graph which shows the relationship between the distortion | strain of a sample, and stress in the tension test of a socket liner.

Explanation of symbols

  DESCRIPTION OF SYMBOLS 11 ... Paste, 13 ... Compound liquid, 16 ... Air mixed liquid, 17 ... Gelling agent, 18 ... Stock solution, 26 ... Socket liner original form, 24 ... Cavity, 31 ... Vulcanizer, 43 ... Socket liner for artificial limbs

Claims (5)

A prosthetic socket liner made of a rubber latex foam made of at least one of isoprene rubber, chloroprene rubber, and deproteinized natural rubber, which has a breathability of 10-30 seconds based on JIS standard P8117. A socket liner for prosthetic limbs that is set. In Claim 1, the tensile strength based on JIS standard K6251 was set to 0.4 to 2.0 MPa, and the tear strength by a not-cut angle type test piece based on JIS standard K6252 was set to 2.0 to 10.0 N / mm. A socket liner for prosthetic limbs characterized by that. The prosthetic socket liner according to claim 1 or 2, wherein the rubber latex foam is made of isoprene rubber. The prosthetic socket liner according to any one of claims 1 to 3, wherein a surface of the prosthetic socket liner is lubricated. A step of blending a rubber latex with a paste to produce a blended solution;
Stirring the compounded liquid and blowing air into the compounded liquid to produce an air mixed liquid;
A step of producing a stock solution for producing a prosthetic socket liner by mixing a gelling agent into the air mixture,
Injecting the stock solution into a mold, and molding a prosthetic socket liner prototype,
A method for producing a socket liner for a prosthetic limb, comprising: a vulcanization step of vulcanizing the original prosthetic socket liner using a vulcanizer to produce a prosthetic socket liner.

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