WO2025128037A1

WO2025128037A1 - Prosthetic liner with herbal content suitable for use in prosthetic products and a method for producing this prosthetic liner

Info

Publication number: WO2025128037A1
Application number: PCT/TR2024/051019
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: 2023-12-13
Filing date: 2024-09-04
Publication date: 2025-06-19
Anticipated expiration: 2026-06-13

Abstract

The invention relates to a prosthetic liner with herbal content developed for use between the stump and the prosthetic socket, which is suitable for use in prosthetic products, flexible, low in toxicity, easy to wear and remove, provided with antibacterial properties, and resistant to external conditions, and a method for producing this prosthetic liner.

Description

PROSTHETIC LINER WITH HERBAL CONTENT SUITABLE FOR USE IN PROSTHETIC PRODUCTS AND A METHOD FOR PRODUCING THIS PROSTHETIC LINER

TECHNICAL FIELD

The invention relates to a prosthetic liner with herbal content developed for use between the stump and the prosthetic socket, which is suitable for use in prosthetic products, flexible, low in toxicity, easy to wear and remove, provided with antimicrobial properties, and resistant to external conditions, and a method for producing this prosthetic liner.

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.

Prostheses are used to provide the function and visuality of a wide variety of body parts, including the upper extremity and lower extremity. Prosthetic limbs are used for varying degrees of amputation/in absence of body parts, for example, after partial finger, finger, partial hand, wrist disarticulation, trans-radial amputation (often referred to as below- elbow or forearm amputation), elbow disarticulation, transhumeral amputation, often referred to as above-elbow amputation, shoulder disarticulation, partial foot, syme, chopart, prigoff, below-knee, above-knee, knee disarticulation, hip disarticulation amputations.

After amputation, before the user wears the prosthesis, a sock, a cover / sheath / interface / lining / liner is worn to protect the skin of the stump. These products preferably consist of materials such as wool, cotton, polyester, polyurethane, silicone, thermoplastic elastomer, etc.

The sock sockets used in prostheses provide contact of the artificial limb with the skin, helping the prosthesis to be worn and removed comfortably and reducing the friction between the prosthesis and the skin. Sock sockets play an important role in improving the comfort and functionality of prosthesis users. Thus, the comfort of the user should also be prioritized. However, it has some disadvantages in long-term use.

Prosthesis users often encounter sweating and moisture problems inside their prostheses. The sweat accumulated inside the sock socket causes a bad smell from the prosthesis and skin irritation.

In long-term use, the sock sockets cause irritation due to friction on the skin. These irritations also cause skin problems over time.

Sweat and bacteria accumulating in the sock sockets cause the prosthesis to smell bad and are socially disturbing. On the other hand, it causes wounds on the skin in long-term use. These wounds cause serious problems in terms of hygiene due to moisture accumulation from the use of the sock socket. And it makes it difficult for wounds to heal and causes infection. With this infection, there are delays in the treatment process.

On the other hand, it should be in a form that the user can wear and remove comfortably. Thus, it is ensured that the comfort of the user is increased in daily life.

For liners made of polymeric material, during the piston movement that occurs in the use of the prosthesis, sound effects such as sucking, humming, and flatulence sounds occur, which are disturbing and often embarrassing to the patient. In these users, it irritates the skin by creating different moments of movement with uneven pressures and loading on the skin.

Many amputees experience stump swelling. Inside a prosthetic socket, the stump tends to contract significantly and expand within a few minutes after the stump is removed from the socket. This expansion and contraction of the remaining limb causes the development of air pockets and the formation of disturbing sounds. A liner sock that is compatible with the expanded stump gathers the stump and becomes compatible with the socket. Over time, the amputee's stump usually shrinks and remains constant in size, and does not tend to change. As these changes occur, the noise and irritations caused by the piston effect described above increase. In this case, it leads to lesions on the stump.

Patent No. US4923474 relates to an arm element to enclose and fix a deformed part of the body, such as an amputation stump. The new sleeve element is primarily intended to aid in the application of a prosthesis and the treatment of a stump, but it is also used for other purposes, such as attaching various auxiliary and educational equipment to an amputation stump.

Patent No. US5201774 provides a valve housing for a prosthetic housing in which a secure, sealed mechanical lock is formed between the valve housing and the housing. Said patent comprises a valve housing with an opening for receiving a removable air relief valve. A blind plug, which is separate from the relief valve, is also located in the opening of the valve seat in a removable manner.

Patent No. US9066821 relates to sling liner sleeves adapted to provide an interface between a limb and a prosthetic housing. In said patent, the liner sleeve has a recessed portion that extends around at least a peripheral portion of the liner sleeve to accommodate the sealing element of the sealing element.

Patent No. US9877851 provides an adjustable sealing system, a sealing component for use in the system, and a method for creating a sealing interface between a residual limb and a prosthetic housing. The sealing component is selectively placed on the outer surface of a suspension liner comprising a large number of sealing bands to which the sealing component can be securely attached and removed. In said patent, the liners may also comprise a different outer coating from elastomeric material, and the exemplary outer coatings are various textiles with different stretchability properties.

As a result, all the above-mentioned problems have made it imperative to make an innovation in the relevant technical field.

SUMMARY OF THE INVENTION The prosthetic liners currently used in the relevant technical field are not resistant to moisture and sweat when in contact with the skin, causing infection and irritation in the skin barrier due to bacterial problems caused by moisture and sweat. The present invention, in order to eliminate the above-mentioned disadvantages and to bring new advantages to the relevant technical field, relates to a prosthetic liner with herbal content developed for use between the stump and the prosthetic socket, which is suitable for use in prosthetic products for preventing skin irritation from moisture and sweat during use, flexible, low in toxicity, easy to wear and remove, resistant to external conditions, and provided with antimicrobial properties.

An object of the invention is to introduce a prosthetic liner that offers an antimicrobial effect.

Another object of the invention is to introduce a prosthetic liner that protects the skin barrier.

Another object of the invention is to introduce a flexible prosthetic liner.

Another object of the invention is to introduce a prosthetic liner with reduced toxicity.

Another object of the invention is to introduce a prosthetic liner resistant to external conditions.

The present invention, in order to eliminate the above-mentioned disadvantages and to bring new advantages to the relevant technical field, relates to a method for producing the prosthetic liner with herbal content developed for use between the stump and the prosthetic socket, which is suitable for use in prosthetic products for preventing skin irritation from moisture and sweat during use, flexible, low in toxicity, easy to wear and remove, resistant to external conditions, and provided with antimicrobial properties.

BRIEF DESCRIPTION OF THE FIGURES

Figure 1 -A refers to the 20 pm view of SEM images of microencapsulated aloe vera gel extract. Figure 1 -B refers to the 10 gm view of SEM images of microencapsulated aloe vera gel extract.

DETAILED DESCRIPTION OF THE INVENTION

In this detailed description, the subject matter of the invention relates to a prosthetic liner with herbal content developed for use between the stump and the prosthetic socket, which is suitable for use in prosthetic products, flexible, low in toxicity, easy to wear and remove, resistant to external conditions, and provided with antimicrobial properties, and a method for producing this prosthetic liner, 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 prosthetic liner with herbal content developed for use between the stump and the prosthetic socket, which is flexible, low in toxicity, easy to wear and remove, resistant to external conditions, provided with antimicrobial properties, and which offers technical solutions and advantages for the relevant technical field. Along with not being resistant to moisture and sweat, the prosthetic liners used in the present art also cause microbial problems due to moisture and sweat. Along with these microbial problems, it causes infection and irritation in the skin barrier.

The sock sockets used in prostheses provide contact of the artificial limb with the skin, helping the prosthesis to be worn and removed comfortably and reducing the friction between the prosthesis and the skin. Sock sockets play an important role in improving the comfort and functionality of prosthesis users. Thus, the comfort of the user is also prioritized.

The prosthetic liners in the prior art cause irritation and infection on the skin when they come into contact with the skin. This discomfort causes discomfort for the user in daily social life. Some arrangements need to be made in prosthetic liners that require longterm use.

The prosthetic lining of the invention contains at least one herbal component. Herbal components have wound healing, skin barrier healing, antimicrobial properties. The herbal component of the invention comprises at least one, several or all of the group of aloe vera, marigold, lavender, thyme, mint, rosemary, fennel, tea tree, lemon oil.

In the most preferred embodiment of the invention, the herbal component contains aloe vera and/or marigold plant. These plants, due to their antioxidant and antibacterial properties, are specially selected to accelerate the healing of wounds. Aloe vera and the marigold plant included in the herbal component of the invention are in gel form. Since the herbal gel composition on the inside of the liner will now be in contact with the skin of a limb when the liner is worn, the gel composition is preferably flat and continuous, such that there are no stitches or other discontinuities that can cause amputee discomfort.

The herbal component of the invention contains aloe vera extract at a value between 0.5 % to 10 % by weight of TPE and/or silicone, which are the main raw material of said liner. The amount of aloe vera extract adjusts the release time.

The herbal component of the invention contains marigold extract at a value between 0.5 % to 10 % by weight of TPE and/or silicone, which are the main raw material of said liner. The amount of marigold extract adjusts the release time. The release time increases at a value between 1 week to 12 months.

In a preferred embodiment of the prosthetic liner of the invention, the herbal component contained therein is microencapsulated.

By spray drying, substances in liquid form are converted into powder form. The feed is sprayed (atomized) into the hot dryer chamber to remove moisture. With spray drying, a spherical-shaped powder product with homogeneous particle size distribution is obtained. Compared to other drying methods, the drying time is short and this situation provides an advantage in the rapid drying of temperature sensitive products. With spray drying, it is ensured that the microencapsulated extract remains in the core part of a coating material. Not only the sensitivity to heat, but also the stability of the extracts is increased with this technique and the material is protected from changes that may occur due to temperature, light and storage conditions. Furthermore, microencapsulated products also offer advantages in terms of the release of active substances from the material.

The microcapsule comprises gum arabic at a value between 1 .5% to 2.5% by weight and maltodextrin at a value between 4% to 8% by weight as raw material. The polysaccharide in aloe vera gel provides a homogeneous distribution in the microcapsule, which is a polymer in its structure.

With the researches carried out in the invention, it is determined that TPE and or silicone material modified with aloe vera microcapsule inhibits the growth of Stapylococcus aureus bacteria by 98.4%. Compared to the antimicrobial activity of the blank silicone material against E. Coli, the modification of the material with Aloe contributes to the antimicrobial activity against E. Coli.

Scanning Electron Microscope (SEM) is an important tool for material analysis. It provides high-resolution images of samples at high magnification at 50000x magnifications.

Microencapsulated Aloe vera gel extract SEM micrographs show that microspheres are formed and there is no clustering even though they are of variable particle sizes. Thus, the extracts mixed homogeneously into silicone and/or TPE penetrate the user's skin evenly. Images are shared in Figures 1 A and 1 B.

The microencapsulated herbal extract, which is deaerated by vacuum, is shaped by injection into a modified silicone liner sock mold, and heat-treated at a value between 20 °C to 80 °C to form an elastic cylinder shape. The mold is cooled and the product is removed. Then, by adhering the same cylinder-shaped textile to the outer surface of the product, both the elasticity direction is adjusted and the product is strengthened and made durable. On the other hand, in TPE material, microencapsulated herbal extract is melted in a modified TPE modified cylinder with a temperature of 130 °C to 220 °C and injected into a mold preheated between 20 °C to 40 °C and covered with a reinforcement textile with pre-adjusted elasticity. As a final processing step, the mold is cooled and the final product is obtained. After the molten product is injected into the mold, it is cooled in order not to deteriorate the surface quality and to increase the production speed. After the mold is reduced to a temperature below room temperature, the product is removed from the mold.

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 prosthetic liner developed for use between the stump and the prosthetic socket in prosthetic products, characterized in that it contains

- at least one herbal component to provide antimicrobial properties,

- at least one of the TPE and/or silicone components as the main raw material.

2. A prosthetic liner according to Claim 1 , characterized in that it contains aloe vera extract as a herbal component.

3. A prosthetic liner according to one of the preceding claims, characterized in that it comprises aloe vera extract at a value between 0.5 % to 10 % by weight of TPE and/or silicone, which are the main raw material of said liner.

4. A prosthetic liner according to one of the preceding claims, characterized in that it contains marigold extract as a herbal component.

5. A prosthetic liner according to one of the preceding claims, characterized in that it comprises marigold extract at a value between 0.5 % to 10 % by weight of TPE and/or silicone, which are the main raw material of said liner.

6. A prosthetic liner according to one of the preceding claims, characterized in that the herbal components it contains are microencapsulated.

7. A prosthetic liner according to Claim 6, characterized in that it contains gum arabic at a value between 1 .5% to 2.5%.

8. A prosthetic liner according to one of Claim 6-7, characterized in that it contains maltodextrin at a value between 4% to 8% by weight.