WO2024177590A1

WO2024177590A1 - A comfortable prosthetic socket

Info

Publication number: WO2024177590A1
Application number: PCT/TR2023/050273
Authority: WO
Inventors: Ramazan UNAL; Noor Alhuda AMEEN
Original assignee: Ozyegin Universitesi
Current assignee: Ozyegin Universitesi
Priority date: 2023-02-23
Filing date: 2023-03-22
Publication date: 2024-08-29
Anticipated expiration: 2025-08-23

Abstract

The invention relates to a prosthetic socket (10) which is positioned in the area where the prosthesis is in contact with the amputee and acts as a buffer between the skin of the person and the prosthesis in the area where the amputation begins. The invention is characterized in that it comprises at least one core body (20), which acts as a main frame body for said prosthetic socket (10) and is formed at least partially to surround the stump of the person with which it is connected, it comprises at least one opening (22) on the surface of the said core body (20), it comprises at least one first region (30) and at least one second region (40), at least some of which are positioned so that they remain within said opening (22) and can be of different thicknesses from different materials.

Description

A COMFORTABLE PROSTHETIC SOCKET

TECHNICAL FIELD

The invention relates to a prosthetic socket which is positioned in the area where the prosthesis is in contact with the amputee and acts as a buffer between the skin of the person and the prosthesis in the area where the amputation begins.

BACKGROUND

Prostheses are devices that are configured to mimic the movements of the limb by replacing the lost limbs of people who have limbs loss due to congenital or later causes. Accordingly, it is ensured that the person has the functions of the relevant limb by placing a prosthesis where there is a loss of limb.

Especially in leg prostheses, a socket is placed between the prosthesis and the person's body. The socket forms a mounting surface for connecting the prosthesis to the body and also serves as a buffer element between the body and the prosthesis. Herein, the prosthesis should be precisely structured so that the person can feel comfortable during the use of the prosthesis. For example, if the prosthesis fitting process is considered for an individual who is amputated below the knee region, it is seen that all surfaces of the person's leg that will come into contact with the socket do not have the same sensitivity level.

Known socket structures are mostly manufactured using a single material without considering the different sensitivity surfaces mentioned above. However, socket embodiments incorporating different materials are also known in the art. These sockets, on the other hand, have high weight structures that are challenging and costly to produce.

Application US2019091043A1 , which is the state of the art, relates to the socket and liner used in prostheses. The invention of the application is intended to provide a prosthetic socket system with increased user comfort and simplified placement in the prosthetic socket. However, a socket that adequately responds to current needs and whose production is facilitated is not disclosed herein. As a result, all the above-mentioned problems have made it imperative to innovate in the relevant technical field.

BRIEF DESCRIPTION OF THE INVENTION

The present invention relates to a prosthesis socket for eliminating the above-mentioned disadvantages and bringing new advantages to the relevant technical field.

An object of the invention is to provide a prosthetic socket that is lightened, easy to manufacture, comfortable, and reliable.

The present invention is a prosthetic socket which is positioned in the area where the prosthesis is in contact with the amputee and acts as a buffer between the skin of the person and the prosthesis in the area where the amputation begins in order to realize all the objects that will emerge from the abovementioned and the following detailed description. Accordingly, the novelty of the invention is in that it comprises at least one core body that acts as a main skeleton body for said prosthetic socket and is formed at least partially surrounding the stump of the person with which it is connected, at least one opening on the surface of the said core body, at least one first region and at least one second region that are positioned at least some parts of them within said opening and can be of different thicknesses from different materials. Thus, different regions of the prosthetic socket can be made of different materials of different thicknesses according to the sensitivity regions of the amputee person's skin.

A possible embodiment of the invention is characterized in that the core body comprises at least one flap, which may be of different thicknesses from a material different from the core body. Thus, it is ensured that the flaps can be selected from a material different from other regions of the prosthetic socket.

Another possible embodiment of the invention is characterized in that the core body is made of Kevlar-based material. Thus, the core body acting as the main frame is ensured to have the desired strength and hardness values.

Another possible embodiment of the invention is characterized in that the flap is made of carbon fiber-based material. Thus, it is ensured that the region corresponding to the flap in the stump of the person has the desired hardness value. Another possible embodiment of the invention is characterized in that the first region is made of PLA-based material. Thus, it is ensured that the first region corresponding to the most sensitive region on the stump of the person has the desired hardness value.

Another possible embodiment of the invention is characterized in that the second region is made of TPU-based material. Thus, it is ensured that the second region corresponding to the second most sensitive region on the stump of the amputee person has the desired hardness value.

A production method for the prosthetic socket of the invention is characterized in that it comprises the following method steps:

- Performing the pain perception threshold test by exposing the amputation region to the pressure for the region where the prosthesis socket will be connected to the amputee person and determining the tissue sensitivities along the amputation region where the prosthesis socket will contact,

- According to the results of the pain perception threshold test, determination of the amputation area as a very sensitive area and a less sensitive area as at least two areas,

- Configuring the prosthetic socket to comprise at least a first region positioned to contact the entire said very sensitive region and at least a second region positioned to contact said less sensitive region,

- Selecting the thicknesses or materials of said first region and said second region to apply pressure below the predetermined pain perception threshold value in the pain perception threshold test to the tissue to be contacted in the amputation region.

Thus, a personalized and comfortable prosthetic socket is presented.

A possible embodiment of the invention is characterized in that it comprises the step of determining the amputation region as four different sensitivity regions, at least one core body, at least one first region, at least one second region, and at least one flap, according to the results obtained in the pain perception threshold test.

Another possible embodiment of the invention is characterized in that it comprises the step of selecting the material or thicknesses for configuring the prosthetic socket to apply pressure below the predetermined pain perception threshold limit value in the pain perception threshold test to the tissue to which said core body, the first region, the second region, and the flap regions will come into contact in the amputation region. Thus, it is possible to determine varied materials or thicknesses for smaller sensitivity changes compared to a two-piece prosthetic socket and the comfort level is increased.

BRIEF DESCRIPTION OF THE FIGURES

Figure 1 shows a representative perspective view of the prosthetic socket of the invention.

Figure 2 shows a representative front view of the prosthetic socket of the invention.

Figure 3 shows a representative side view of the prosthetic socket of the invention.

DETAILED DESCRIPTION OF THE INVENTION

In this detailed description, the subject matter of the invention is explained only by means of examples that will not have any limiting effect for a better understanding of the subject matter.

Figure 1 shows a representative perspective view of the prosthetic socket (10) of the invention. The said prosthetic socket (10) is positioned between the prosthesis to be placed in the place of the relevant limbs of amputee persons such as arms and legs and the body of the person. These prostheses may be below the knee, above-the-knee prostheses, arm prostheses, etc. The prosthesis socket (10) serves as an intermediate element between the person's tissue and the prosthesis at the point where these prostheses will contact the person.

The prosthetic socket (10) includes at least one core body (20). The core body (20) is the structure that forms the main skeleton of the prosthetic socket (10). The core body (20) is configured to at least partially include the stump to which the prosthetic socket (10) is to be connected. Accordingly, for example, for a below-knee prosthesis, the core body (20) is configured to partially include the upper leg of the person. It is the representation of the prosthetic socket (10) and the core body (20) given in the Figures. The core body (20) has predetermined dimensions and shape according to the person to whom the prosthesis will be connected and which prosthesis is applied. Accordingly, the shape of the core body (20) is determined by the measurements made beforehand.

The prosthetic socket (10) comprises at least one flap (21 ). The flaps (21 ) are protruding from the core body (20) towards the upper portion of the residual limb of the person. The prosthetic socket (10) comprises two flaps (21 ) opposite each other in a possible embodiment of the invention. The prosthetic socket (10) comprises at least one first region (30). The first region (30) is essentially a wall of the prosthetic socket (10) that contacts the amputee person's body. There is at least a second region (40) on both sides of the first region (30). The second region is essentially the lateral wall of the prosthetic socket (10) that contacts the amputee person's body. The first region (30) and the second region (40) are subsequently placed in the prosthetic socket (10). Accordingly, the first region (30) and the second region (40) are removably connected to the prosthetic socket (10). The prosthetic socket (10) comprises at least one connection part (50) to enable the first region (30) and the second region (40) to be removably connected to each other and the core body (20). The connection part (50) may be a pin in a possible embodiment of the invention.

According to the preferred embodiment of the invention, the first region (30), the second region (40), the core body (20), and the flaps (21 ) are made of different materials. However, the first region (30), the second region (40), the core body (20), and the flaps (21 ) may be of different thicknesses from each other. The widths and thicknesses of the mentioned regions are also determined according to the predetermined values.

There is at least one opening (22) on the core body (20). The opening is essentially a space located on the surface of the core body (20). The first region (30) and the second region (40) are arranged so that at least some of them correspond to the opening (22). The opening (22) allows the first region (30) and the second region (40) to flex outwardly through the core body (20).

The materials of the core body (20), the flap (21 ), the first region (30), and the second region (40) are selected according to the sensitivity of the tissue in contact with the stump of the person. Accordingly, softer materials are preferred for the region with the highest sensitivity. Harder materials are preferred in regions with less sensitivity and in regions that serve as load carriers. In addition to the type of materials, the hardness levels of the regions can be adjusted with their thickness. The placements and surface widths of the core body (20), the first region (30), the second region (40), and flaps (21 ) shown in the Figures are representative, and the distributions of all these regions on the prosthetic socket (1 ) are essentially determined individually. For this, the distribution of the sensitivity regions in the tissue of the person that will come into contact with the prosthetic socket (1 ) is observed. For example, the first region (30), which will contact the most sensitive tissue in the prosthetic socket (10), may consist of more than one part if it is determined that the person has more than one sensitive region in separate regions. There are currently some methods used to determine tissue sensitivities and pain perception thresholds. Accordingly, the region where the sensitivity is desired to be determined is subjected to the pressure of various magnitudes. Accordingly, a pressure-time graph is created, and the pain perception threshold graph of the person is created by increasing the pressure gradually. Two critical values, namely the pain perception threshold and the pain tolerance threshold, are determined in these graphs. The pain perception threshold is the limit value at which a person begins to feel pain for the first time due to an increase in pressure. The pain tolerance threshold is the limit value of the maximum pain a person can withstand.

The prosthetic socket (1 ) of the invention, intends to expose the amputated person's amputation region to a pressure smaller than the limit values at the pain perception threshold. Accordingly, the following method steps are followed while manufacturing the inventive prosthetic socket (1 ):

- Performing the pain perception threshold test by exposing the amputation region to the pressure for the region where the prosthesis socket (1 ) will be connected to the amputee person and determining the tissue sensitivities along the amputation region where the prosthesis socket (1 ) will contact,

- According to the results obtained in the pain perception threshold test, the amputation region is divided into at least two regions: a very sensitive region and a less sensitive region,

- Configuring the prosthetic socket (1 ) to comprise at least a first region positioned to contact the entire said very sensitive region and at least a second region positioned to contact said less sensitive region,

- Selecting the thicknesses or materials of said first region and said second region to apply pressure below the predetermined limit value in the pain perception threshold test to the tissue to be contacted in the amputation region,

In this way, a pressure below the pain perception threshold is formed for the contacted tissue along the entire surface area where the prosthesis socket (1 ) contacts the amputee person. Thus, the amputee person does not feel any pain during the use of the prosthetic socket (1 ) since they do not feel any pressure at or above the pain perception threshold in any region that comes into contact with the prosthetic socket (1 ).

The said pain perception threshold tests are performed specifically for the amputation region for each amputee person. All movements that the person will make with the prosthesis are simulated during the test. For example, for a below-knee prosthesis to be connected to the prosthesis socket (1 ), the maximum forces that the prosthesis socket (1 ) and therefore the amputation region can be exposed and the pressures that will occur due to it, such as walking, sit-to-stand, slope ascending-descending, stair ascending-descending, are considered.

In a preferred embodiment of the invention, the prosthetic socket (1 ) is manufactured to consist of four separate regions in accordance with the tests. Accordingly, the amputation region is divided into four different sensitivity regions and thus different materials and different thicknesses can be selected for smaller sensitivity differences in the tissue compared to the two-piece structure. The relatively softest material in the material group is selected for the first region (30). The second region (40) is less sensitive than the first region (30). The core body (20) is selected from the relatively hardest material in the material group due to the load it carries. The widths and distributions of the core body (20), the first region (30), the second region (40), and the flaps (21 ) may vary individually. The thickness of the material to be used in these regions can also be manufactured according to the desired flexibility and hardness. In the preferred embodiment of the invention, at least one of the core bodies (20), the flaps (21 ), the first region (30), and the second region (40) is manufactured by the additive manufacturing method. In this way, it is ensured that the prosthesis socket (10) can be manufactured easily and at low costs. The material of the connection part (50) can also be selected according to the load to be placed on it. However, the material of the connection part (50) may be one of the materials of the parts it joins.

In a possible embodiment of the invention,

The core body (20) is essentially made of Kevlar-based material.

The flaps (21 ) are made of carbon fiber.

The first region (30) is made of PLA-based material.

The second region (40) is essentially made of TPU-based material.

The prosthetic socket (10) of the invention can be manufactured with different materials and walls of different thicknesses for the regions with different sensitivity on the stump of the person with its fragmented structure. Since the amputation regions and the sensitivity regions are areas that can vary from person to person, the personal configuration of the prosthetic socket (10) of the invention significantly increases the comfort of prosthetic use. Thanks to the connection part (50) included in the prosthetic socket (1 ), this structure can also be removed and installed. A prosthetic socket (10) that offers a high level of comfort and safety is presented with this whole embodiment.

The protection scope of the invention is specified in the appended claims and cannot be strictly limited to those explained in this detailed description for illustrative purposes. It is evident that a person skilled in the art may exhibit similar embodiments in light of the foregoing without departing from the main theme of the invention.

REFERENCE NUMBERS GIVEN IN THE FIGURE

10 Prosthetic Socket

20 Core Body

21 Flap

22 Opening

30 First Region

40 Second Region

50 Connection Part

Claims

1. The invention is a prosthesis socket (10) which is positioned in the area where the prosthesis is in contact with the amputee and acts as a buffer between the skin of the person and the prosthesis in the area where the amputation begins and characterized in that it comprises at least one core body (20) that acts as a main skeleton body for said prosthesis socket (10) and is shaped to at least partially surround the stump of the person that is connected to the prosthesis, at least one opening (22) on the surface of the said core body (20), at least one first region (30) and at least one second region (40) of different thicknesses of varied materials, positioned so that at least part of them are located within the said opening (22).

2. A prosthetic socket (10) according to Claim 1 , characterized in thatthe core body (20) comprises at least one flap (21 ) that can be of different thicknesses from a material different from the core body (20).

3. A prosthetic socket (10) according to Claim 1 , characterized in thatthe core body (20) is made of Kevlar-based material.

4. A prosthetic socket (10) according to Claim 1 , characterized in that the flap (21 ) is made of carbon fiber-based material.

5. A prosthetic socket (10) according to Claim 1 , characterized in that the first region (30) is made of PLA-based material.

6. A prosthetic socket (10) according to Claim 1 , characterized in that the second region (40) is made of TPU-based material.

7. A production method for the prosthetic socket (1 ) of the invention, characterized in that it comprises the following method steps:

- Performing the pain perception threshold test by exposing the amputation region to the pressure for the region where the prosthesis socket (1 ) will be connected to the amputee person and determining the tissue sensitivities along the amputation region where the prosthesis socket (1 ) will contact, - According to the results of the pain perception threshold test, determination of the amputation area as a very sensitive area and a less sensitive area as at least two areas,

- Configuring the prosthetic socket (1 ) to comprise at least a first region (30) positioned to contact the entire said very sensitive region and at least a second region (40) positioned to contact said less sensitive region,

- Selecting the thicknesses or materials of said first region (30) and said second region (40) to apply pressure below the predetermined pain perception threshold value in the pain perception threshold test to the tissue to be contacted in the amputation region.

8. A method according to Claim 7, characterized in that it comprises the step of determining the amputation region as four different sensitivity regions as at least one core body (20), at least one first region (30), at least one second region (40) and at least one flap (21 ) according to the results obtained in the pain perception threshold test.

9. A method according to Claim 8, characterized in that it comprises the step of selecting the material or its thicknesses so that the prosthetic socket (1 ) is configured to apply pressure below the pain perception threshold limit value determined in the pain perception threshold test to the tissue to which said core body (20), the first region (30), the second region (40) and the regions of the flap (21 ) will come into contact in the amputation region.