WO2025080225A1

WO2025080225A1 - A composite material suitable for use as a modular adapter and joint and a method for producing this composite material

Info

Publication number: WO2025080225A1
Application number: PCT/TR2024/051018
Authority: WO
Inventors: Mustafa Avci
Original assignee: Nish Teknoloji Tasarim Ve Gelistirme Sanayi Ve Ticaret AS
Current assignee: Nish Teknoloji Tasarim Ve Gelistirme Sanayi Ve Ticaret AS
Priority date: 2023-10-12
Filing date: 2024-09-04
Publication date: 2025-04-17
Anticipated expiration: 2026-04-12

Abstract

The invention relates to a corrosion-resistant composite material suitable for use as a modular adapter, orthotic part and joint in prosthetic products, and the production method of this composite material.

Description

A COMPOSITE MATERIAL SUITABLE FOR USE AS A MODULAR ADAPTER AND JOINT AND A METHOD FOR PRODUCING THIS COMPOSITE MATERIAL

TECHNICAL FIELD

The invention relates to a corrosion-resistant composite material suitable for use as a modular adapter, prosthetic and orthotic joint in prosthetic products, and the production method of this composite material.

PRIOR ART

Amputation is the separation of any part of the arm or leg from the body by cutting it after trauma or surgery. Amputation occurs due to different reasons. Amputation can be due to trauma such as occupational accidents, traffic accidents, and war injuries, and also can be performed as a surgical treatment due to any disease such as bone or soft tissue tumor in the arm or leg, infection, blood supply disorder due to vascular disease, excessive tissue damage or dysfunction. The part of the limb that remains with the patient after amputation is called the stump. The length of the stump also varies according to the level at which the amputation is performed. As the amputation level approaches the finger level, the length of the stump increases. There are 3 types of amputations: major, lower limb and transfemoral amputation.

Major amputation: amputations performed above the level of the hand in the arm and above the level of the heel of the leg are defined as major amputations. All amputations performed from below the hip joint and pelvis level are lower limb amputations. Transfemoral amputation is an amputation that occurs when the leg is cut at a level between the knee and the hip joint.

Prostheses are externally applied prosthetic limbs in the form of fingers, hands, arms, legs, which are prepared to fulfill the functions of that limb and visually provide body integrity in case of complete or partial loss of a limb due to any congenital or acquired reason. Furthermore, there are prostheses that are applied internally in the joints. As a result of injuries, tumor surgeries, gangrene, inflammation and similar organ damage, the damaged organ is removed in order to protect the health of the rest of the body. Prostheses that mimic the function and shape of this organ are attached to the body cavity remaining from this organ using auxiliary materials.

The socket is the most basic and important prosthetic material that connects the prosthesis to the stump, that is, into which the stump enters. The socket is specially designed and produced according to the shape of the stump, the nerve structure and skin structure of the person.

In general, a customized socket is manufactured for the stump. These sockets are made of polyester, epoxy, polyethylene, polypropylene and similar materials. Reinforcements such as carbon, kevlar, and fiberglass are used.

Adapters describe the components located at the connection points of the limbs. They vary depending on the limb. The prosthesis adapter is always fixed directly under the prosthesis socket. Often, the practitioner places a pylon and various adapter components on the prosthetic limb. Especially when making thigh prostheses, the adapter connection point is sometimes moved distal to the socket in order to be able to attach the prosthetic knee joint in line with the pivot point of the prosthetic knee joint without using additional adapters. The socket is integrated with a socket adapter manufactured in different shapes so that it can be combined with other constituents of the prosthesis. The locking mechanisms used to provide suspension with the socket adapter, the adapters used to adapt according to gravity and/or to adjust the length are present in the prosthesis. An amputation at the hip level includes mechanical, pneumatic, hydraulic and similar joints that will provide hip joint movement. Mechanical, pneumatic, hydraulic, microprocessor controlled knee joints are attached under these adapters. The joints can be attached directly to the tube with adapter, or the tube adapter is used to connect the joint and the tube with adapter. An ankle adapter is attached at the ankle level of the tube adapter and a prosthetic foot is attached under the ankle adapter. These adapter connections are similar to the shape of an inverted pyramid and are designed to be tightened with 4 screws in order to keep this pyramid stable and to position it at a 4-way angle.

In the prior art, adapters are produced by machining from aluminum, stainless steel, titanium materials, and types and combinations of these materials. There are many operation processes in this manufacturing process. The raw material mass and / or the metal mass formed by the investment casting technique are finalized by turning, milling and similar metal processing methods. Shaped metals are subjected to surface cleaning, polishing, painting and/or heat treatment. The manufacturing process of prosthetic components produced using conventional methods is quite long. The conventional production process increases the amount of waste of metals and the energy consumption used in production. Aluminum, stainless steel, and titanium materials used to produce prosthetic components increase the weight of the final product. Combinations of these metals are preferred in the production of prosthetic components according to factors such as weight, mechanical properties, production time, and energy consumption. The preferred material must comply with mechanical properties such as brittleness, ductility, elasticity, fatigue, hardness, machinability, plasticity, flexibility, rigidity, toughness and yield strength. The weights and specific weights of prosthetic and orthotic components are important in terms of providing comfortable use and longevity for users.

In prosthesis users in the growth and development period, components or all of the prosthesis and orthosis should be replaced depending on the growth. In this case, the practitioner needs to change the main components of the limb, and as the person's height and weight change, even a completely new prosthetic limb or auxiliary is needed. Replacing the main prosthetic components is expensive, both in terms of materials and the time of the practitioner, and also inconvenient.

Application No. US5545230 relates to prosthetic devices, and particularly to an improved adapter and method for facilitating mounting of prosthetic devices, with the device and method particularly advantageous for a Symes amputee.

Application No. SE542686 relates to a prosthetic adapter module configured to be attached to a socket element of a prosthetic sheath to be used to connect a prosthetic limb device such as a leg, foot, or arm.

As a result, it has become necessary to make innovations in order to eliminate the above- mentioned technical problems.

SUMMARY OF THE INVENTION

The invention relates to a composite material suitable for use as a modular adapter, prosthetic and orthotic joint in prosthetic products. The specific weights of metals such as aluminum, titanium, and steel used in the prior art is different from each other, and since they are heavy and not resistant to corrosion, a lighter and corrosion-resistant material is needed.

The object of the present invention is to introduce a composite material with a lower specific weight than aluminum, steel, and titanium, and therefore lighter.

Another object of the present invention is to provide a corrosion-resistant composite material.

The invention relates to a method for the production of a composite material suitable for use as a modular adapter in prosthetic products.

Another object of the present invention is to introduce a composite material by plastic injection molding.

BRIEF DESCRIPTION OF DRAWINGS

The adapter assembly subject to the present invention is shown in Figure 1 .

DETAILED DESCRIPTION OF THE INVENTION

In this detailed explanation, the invention relates to a lightweight and corrosion-resistant composite material suitable for use as a modular adapter, prosthetic and orthotic joint in prosthetic products, and a method for producing this composite material, and is described by way of non-limiting examples only for a better understanding of the subject matter.

The inventors of the present invention introduce a lightweight and corrosion-resistant composite material suitable for use as a modular adapter, prosthetic and orthotic joint in prosthetic products, which offers technical solutions and advantages for the relevant technical field. The adapter assembly of the present art is shown in Figure 1 . Although the aluminum used in the present art is light and corrosion-resistant, it is less resistant to load, titanium is a hard and expensive metal and is difficult to shape, steel is not preferred to be used due to its increasing of weight resulting from its high specific weight, therefore the object of the present invention is to introduce a composite material instead of these metals.

“Modular adapter” is referred to as connection components in prosthetic products. Adapters are included as components located at the connection points of the limbs. They vary depending on the limb. The prosthesis adapter is always fixed directly under the prosthesis socket. Often, the practitioner places a pylon and various adapter components on the prosthetic limb.

The subject matter of the present invention relates to a composite material suitable for use as a modular adapter, prosthetic and orthotic joint in prosthetic products. The composite material obtained in the invention is used as a raw material in the production of modular adapter and prosthetic and orthotic joint. By means of modular adapters obtained from composite material, prosthetic limbs with the desired length and orientation are connected to each other in a replaceable and/or adjustable manner.

The composite material of the invention contains at least one matrix and at least one reinforcing component. While the matrix components within the composite material provide permanent form properties such as the mechanical properties of the final product; reinforcing components are included to provide additional properties to the properties of the matrix components.

The composite material of the present invention includes plastic materials. By adding carbon fibre and/or fiberglass and/or graphene and/or graphite doped PTFE to the matrix components within the present invention, which are called plastic materials, brittleness, ductility, elasticity, fatigue, hardness, machinability, plasticity, flexibility, rigidity, toughness and yield strength are achieved.

The composite material of the present invention contains as matrix components at least one selected from the group of acrylonitrile butadiene styrene (ABS), liquid crystal polymers (LCP), polybutylene terephthalate (PBT), polymethyl methacrylate (PMMA), Polytetrafluoroethylene (PTFE), polyamide (PA), polyarylsulfone (PSU/P/PPSU), polycarbonate (PC), polyimide (PI), polyoxymethylene (POM), polyphthalamide (PPA), polyphenylene sulfide (PPS), polyvinylidene fluoride (PVDF), thermoplastic polyester elastomer (TPE-E), and ultra-high molecular weight polyethylene (UHMWPE). Said components are corrosion-resistant components, ensuring that the final product is corrosion-resistant and lightweight. By adding carbon fibre and/or fiberglass and/or graphene and/or graphite doped PTFE to these components, the desired material having brittleness, ductility, elasticity, fatigue, hardness, machinability, plasticity, flexibility, rigidity, toughness and yield strength is achieved.

In a preferred embodiment of the present invention, the matrix component is the polyphenylene sulfide (PPS) component. PPS mechanical strength is more durable, moisture resistant and more rigid than other conventional thermoplastics.

In a preferred embodiment, the composite material of the present invention contains the matrix component at a value in the range of 1% to 95% by weight.

The present invention is related to composite material and contains reinforcing components. These reinforcing components contain at least one of carbon fibre and/or fiberglass and/or graphene and/or graphite doped thermoplastic materials. Since said components are light and corrosion-resistant, the composite material is also light and corrosion-resistant.

In a preferred embodiment, the composite material of the present invention contains the rei nforcing/f iller component at a value in the range of 1% to 80% by weight.

In the most preferred embodiment of the present invention, the composite material contains at least one of the carbon-reinforced PPS (Polyphenylene Sulfide) and/or Polytetrafluoroethylene (PTFE).

In the present invention, the composite material contains at least one filler in addition to containing at least one matrix component and at least one reinforcing component. The number of said filler can be more than one. Here, the filler can be added to prevent adhesion, increase softness and flexibility, perform coloring, increase the strength values against temperature and mechanical effects, prevent fading and brittleness against external influences, and reduce costs before it is shaped for the final product. In a preferred embodiment of the present invention, carbon is used as a reinforcing component for reinforcement and teflon is used for corrosion resistance.

In the present invention, the composite material to be shaped may be in the form of powder, fragments, granules or tablets.

In the present invention, shaping methods are performed as injection and extrusion methods applied for thermoplastics. In the production method, the plastic which is heated and sent to the mold is shaped here by pressure and turned into a prosthetic component.

The modular adapters of the present invention are obtained by plastic injection method. Injection molding is a production process that allows a plastic, metal, or other material to be melted and injected into a mold to take the desired shape. The melting temperature of the PPS component used in the injection molding process of the present invention is at a value between 275 °C to 292 °C and the melting temperature of the PTFE component is between 320 °C to 350 °C. PPS is melted at temperature ranges of 275 °C to 292 °C and PTFE is added to it at temperature values of 320 °C to 350 °C. Also, the injection molding process of the present invention has a duration value between 17 to 25 seconds.

The scope of protection of the invention is specified in the appended claims and cannot be limited to what is described for illustrative purposes in this detailed description. It is clear that a person skilled in the art can produce similar embodiments in the light of what is explained above, without deviating from the main theme of the invention.

Claims

1. A corrosion-resistant composite material suitable for use as a modular adapter in prosthetic products, characterized in that it contains

- A matrix component comprising at least one of acrylonitrile butadiene styrene (ABS), liquid crystal polymers (LCP), polybutylene terephthalate (PBT), polymethyl methacrylate (PMMA), polyamide (PA), polyarylsulfone (PSU/P/PPSU), polycarbonate (PC), polyimide (PI), polyoxymethylene (POM), polyphthalamide (PPA), polyphenylene sulfide (PPS), polyvinylidene fluoride (PVDF), Polytetrafluoroethylene (PTFE), thermoplastic polyester elastomer (TPE-E), and ultra-high molecular weight polyethylene (UHMWPE),

- A reinforcing/filler/additive component comprising at least one selected from the group of carbon fibre and/or fiberglass and/or graphene and/or graphite doped PTFE reinforced thermoplastic materials.

2. A composite material according to claim 1 , characterized in that it contains at least one matrix component at a value in the range of 1 % to 95% by weight.

3. A composite material according to claim 1 , characterized in that it contains at least one reinforcing/filler/additive component at a value in the range of 1% to 85% by weight.

4. A method for producing a corrosion-resistant composite material suitable for use as a modular adapter, orthotic part and joint in prosthetic products, characterized in that it is made by plastic injection molding.

5. A method according to claim 4, characterized in that the melting temperature of the PPS component used in injection molding is at a value between 275 °C to 292 °C.

6. A method according to one of claims 4-5, characterized in that the melting temperature of the PTFE component used in injection molding is at a value between 320 °C to 350 °C.

7. A method according to one of claims 4-6, characterized in that the injection molding process has a duration value between 17 to 25 seconds.