WO2022025850A1

WO2022025850A1 - Hip prosthesis systems used in femoral head and acetabulum bone deformations

Info

Publication number: WO2022025850A1
Application number: PCT/TR2021/050728
Authority: WO
Inventors: Fatih OZAYDIN; Mustafa CETIN; Serdar OZMEN; Ozlem ARI
Original assignee: Estas Eksantrik Sanayi Ve Ticaret Anonim Sirketi; So Saglik Ortopedi Medikal Elektrik Insaat Taahhut Proje Ithalat Ihracat Pazarlama Ve Ticaret Limited Sirketi
Priority date: 2020-07-28
Filing date: 2021-07-13
Publication date: 2022-02-03
Also published as: TR202012007A2

Abstract

The invention relates to hip prosthesis systems used to treat the deformation of the femoral and acetabulum bones in the hip joints and is characterised in that; containing: roximal femoral trunk (5) that - is composed of Ti6A14V ELI (Grade 23) material whose yield and elongation values, thus strength are increased, - adhesion of the prosthesis to the region driven into the bone is increased by special chemical etching and sandblasting, and - its biocompatibility is increased by performing the anodic oxidation process as a result of the reactions on the electrodes in the electrolytic environment, Stem (support nail) (10), which has an angle adjustment notch (14) to be fixed at the desired angle, and which is placed in the bone tissue to get support from the neighbouring bone tissues so that the products can be implanted, Bipolar cup (1), which connects the hip prosthesis system to the articular cartilage of the acetabulum in the bone, and The acetabulum (12), which connects the total hip prosthesis system to the ilium bone.

Description

Hip Prosthesis Systems Used in Femoral Head and Acetabulum Bone

Deformations

Technical Field The invention relates to hip prosthesis systems used to treat the deformations of the femoral and acetabulum bones in the hip joints.

Prior Art

The platinum made of metal compatible with the body, which is used in cases where the hip joint cannot function and replaces the hip joint, is called hip prosthesis. Hip prostheses are used in hip fractures and in cases where the hip joint needs to be removed such as cancer.

Hip prostheses in the prior art cannot be applied to various amounts of deformations. Since it cannot be a solution to various deformation amounts, it extends the operation times considerably. The designs of the hand tools used in hip prostheses in the prior art are insufficient.

The inadequacy of the designs also extends the operation times considerably.

Partial hip prosthesis is mentioned in the European patent document coded EP2512379 in the prior art. The prosthesis in the mentioned patent document reduces friction and wear in partial hip prosthesis by combining the surface treatment of the prosthetic component and the optimized geometry of the articulation. The acetabulum is engraved into the bone. One of the articulated surfaces, either that of the carved acetabulum or that of the femoral head prosthesis, is spherical, thus fluid-filled cavity is created in the significant load transfer area. The fluid-filled cavity is sealed with a circular contact area where the concave and convex components are compatible. The preferred surface treatment is by means of a diamond-like coating, which results in a very low coefficient of friction against bone and high wear resistance. The prosthetic head is fixed to the femur by a perforated shell with a conventional root or by a femoral neck prosthesis screwed onto the femur, so that it is partially covered by bone and partially exposed downwards towards the centre where it rests on the carved cortex of the calcar region. The prosthesis in the said patent document cannot be applied in various amounts of deformations. In addition, due to the design of the prosthesis, the hand tools used during assembly are quite more. The large number of hand tools used extends the operation time.

Purpose of the Invention

The purpose of the invention is to obtain a hip prosthesis that can be applied in various amounts of deformations.

Another purpose of the invention is to obtain a hip prosthesis with increased biocompatibility.

Another purpose of the invention is to minimise the hand tools used during the application of the prosthesis.

Another purpose of the invention is to increase the yield and percent elongation values 1.5 times more than the Ti 4 material.

Another purpose of the invention is to provide more strength in small diameter implants considering the yield value and percent elongation value.

The system developed to realize the mentioned objectives includes bipolar cup (1), wear plate (2), segment (3), head (4), proximal femoral trunk (5), tissue holes (6), bolts (7), hip prosthesis cap (8), hip prosthesis connector region (9), support nail (stem) (10), screws (11), acetabulum (12), total system wear plate (13) and angle adjustment notch (14).

Description of Figures

Attached Figure - 1 is the top perspective view of the disassembled hip prosthesis. Figure-2 is the detailed view of the hip prosthesis.

Figure-3 is the top perspective view of the assembled hip prosthesis.

Figure-4 is the top perspective view of the disassembled version of the total system hip prosthesis. Figure-5 is the detailed view of the total system hip prosthesis.

Figure-6 is the top perspective view of the assembled total system hip prosthesis. The main parts expressed in the figures are given below as numbers and names.

(1) Bipolar cup

(2) Wear plate (3) Segment

(4) Head

(5) Proximal femoral trunk

(6) Tissue holes

(7) Bolts (8) Hip prosthesis cap

(9) Hip prosthesis connector region

(10) Support spike (stem)

(11) Screws

(12) Acetabulum (13) Total system wear plate

(14) Angle adjustment notch

Explanation of the Invention

The invention relates to hip prosthesis systems used to treat the deformation of the femoral and acetabulum bones in the hip joints. The hip prosthesis system subject to the invention includes bipolar cup (1), wear plate (2), segment (3), head (4), proximal femoral trunk (5), tissue holes (6), bolts (7), hip prosthesis cap (8), hip prosthesis connector region (9), support nail (stem) (10), screws (11), acetabulum (12), total system wear plate (13) and angle adjustment notch (14). Ti6A14V ELI (Grade 23) was used as the material of the proximal femoral trunk (5) of the hip prosthesis. The yield and percent elongation values are 1.5 times higher than the Ti 4 material used in hip prostheses in the prior art. Considering the yield value and percent elongation value, more strength is provided with small diameter implants. Hip prosthesis systems can be applied up to 250 mm deformations. The hip prosthesis proximal femur trunk (5) and the support nail (10) are connected to each other with a spacer part (connection module). In this case, as the deformation increases in the region where the hip prosthesis will be placed, the spacer pieces can be attached to each other like a puzzle piece and extend the length of the prosthesis. Spacer parts offer solutions up to 250 mm.

For bone-implant adhesion, chemical etching process special to Ti6A14V ELI (Grade 23) material is applied on the surfaces of the hip prosthesis trunk. After the chemical etching process, the surfaces are sandblasted to increase the adhesion of the prostheses to the region driven into the bone. The biocompatibility of the surfaces of hip prosthesis trunks is increased by performing the anodic oxidation process because of the reactions occurring on the electrodes in the electrolytic environment.

Support nails (10) of various diameters and lengths can be attached to the trunk, thanks to the hip prosthesis cap (8) and the uniform convector in the proximal femoral trunk (5), which are included in the hip prosthesis systems subject to the invention.

There are tissue holes (6) on the hip prosthesis trunk, which is subject to the invention. The tissue holes (6) are used for the attachment of the tendons. Since the places where the muscles attach to the bone are cut during the surgery and thus there is no place for the muscles to attach, tissue holes (6) are left on the prosthesis for the tendons to be attached.

In the surgery, the physician is offered incisions between 45 mm and 250 mm with 10 mm intervals. The possibility of incision between 45 mm and 250 mm given to physicians in surgery is related to the application of hip prosthesis in deformations up to 250 mm. An incision is made during the surgery as much as the size of the deformed area. Since spacer parts are a solution up to 250 mm, the physician can perform a surgical operation on the area between 45 mm and 250 mm.

The stems (10) placed in the bone are brought to the desired angle by means of the angle adjustment notch (14) in the hip prosthesis cap (8).

There are hand tools special to hip prosthesis in the application set to be used in the surgical operation. While 158 hand tools are used in hip prostheses used in the prior art, this number is 58 in the hip prosthesis system subject to the invention. By reducing the mentioned number of tools, the duration of the operation was shortened by 40 %. The fact that the hip prosthesis is a solution to the deformations that are found to be too wide ensures that the prosthesis is the solution with a single surgical operation and a single set. The fact that one set of hand tools is sufficient reduces the number of hand tools. The hip prosthesis subject to the invention works in harmony with the Diaphyseal and Arthrodesis Endoprosthesis systems used for tissue reconstruction because of the loss of bone tissues in the limbs due to various reasons that cannot be repaired. Stems (10) and hip prosthesis connector region (9) with the same design ensure that hip prostheses and Diaphyseal and Arthrodesis Endoprosthesis Systems work in harmony with each other. Stems (10) are the parts placed in the bone tissue in order to get support from the neighbouring bone tissues so that the products can be implanted. The hip prosthesis connector region (9) is used for joining more prosthesis parts in cases where the loss of bone tissue is greater than the product dimensions. The region where the connector is located is generally called the connector region (9).

Hip prosthesis system steps, which are designed and produced, are divided into two as bipolar and total system steps. If there is deformation in the femur line and femur bone, bipolar systems are used; if there is deformation in the hip bone, total systems are used.

In hip prosthesis, the bipolar system works in the following steps:

- The damaged bone is cut and removed,

- The support nail belonging to the hip prosthesis systems is driven into the femur bone and fixed.

- The proximal femoral trunk (5) is fixed at the ideal angle and position.

- The proximal femoral trunk (5) is attached to the connector part located in the hip prosthesis connector region (9) and the hip prosthesis cap (8) is tightened with bolts (7).

- The head (4) is driven into the proximal femoral trunk (5). - The wear plate (2) is driven into the bipolar cup (1) and fixed with the segment (3). The prepared system is placed on the head (4).

- Finally, the system is placed in the acetabulum (12) region by the physician. If there is only a femoral problem in the deformation of the hip, the hip prosthesis system shown in figure- 1 is used. The hip prosthesis system is attached to the articular cartilage of the acetabulum in the bone together with the bipolar cup (1).

In hip prosthesis systems, the total system works in the following steps:

- The damaged bone is cut and removed. - The support nail (10) belonging to the hip prosthesis systems is driven into the femur bone and fixed.

- The proximal femoral trunk (5) is fixed at the ideal angle and position.

- The head (4) is driven into the proximal femoral trunk (5).

- The part of the acetabulum (12) in total hip prosthesis is nailed to the head (4).

- Finally, the hip bone cavity is excavated, and the acetabulum (12) part is fitted by the physician. If the deformation in the hip is also seen in the acetabulum joint cartilage in the bone, that is, if the acetabulum joint cartilage needs to be replaced, the total hip prosthesis systems in Figure-4 are used. In the mentioned total hip prosthesis system, since the acetabulum articular cartilage in the bone is deformed, the total hip prosthesis is connected to the ilium bone with the acetabulum (12). The bipolar cup (1) and head (4) part of the hip prosthesis subject to the invention is made of chrome cobalt, the segment (3) and the wear plate (2) are made of UHMWPE (Ultra High Molecular Volume Polyethylene). Thanks to the material used, the life of the system is considerably extended. The part of the acetabulum (12) used in total systems is also produced from chrome cobalt.

In the bipolar cups (1) in the hip prosthesis systems in Figure-1, a segment (3) is used to provide fixation with a liner. The head (4) in Figure- 1 and the bipolar cup (1) are connected to each other by the wear plate (2). Said wear plate prevents wear.

Two different types of femoral trunks can be used in hip prosthesis systems: the paediatric proximal femoral trunk (5) used in children and the normal proximal femoral trunk (5) used in adults. The size of the paediatric product group is 027 mm, and the size of the trunk used for adults is 030 mm. The size range of hip prostheses varies between 021-027-033-039. The size chosen among the mentioned ranges may vary depending on the adultness, paediatrics, age and gender of the person.

Claims

C L A I M S

1. The invention relates to hip prosthesis systems used to treat the deformation of the femoral and acetabulum bones in the hip joints and is characterised in that; containing: proximal femoral trunk (5) that

-is composed of Ti6A14V ELI (Grade 23) material whose yield and elongation values, thus strength are increased,

- adhesion of the prosthesis to the region driven into the bone is increased by special chemical etching and sandblasting, and

-its biocompatibility is increased by performing the anodic oxidation process as a result of the reactions on the electrodes in the electrolytic environment, stem (support nail) (10), which has an angle adjustment notch (14) to be fixed at the desired angle, and which is placed in the bone tissue to get support from the neighbouring bone tissues so that the products can be implanted,

- bipolar cup (1), which connects the hip prosthesis system to the articular cartilage of the acetabulum in the bone, and

- the acetabulum (12), which connects the total hip prosthesis system to the ilium bone.

2. A hip prosthesis system mentioned in Claim 1 and is characterised in that; containing a spacer part (connection module) that connects the proximal femoral trunk (5) and the support nail (10).

3. A hip prosthesis system mentioned in Claim 1 and is characterised in that; hip prosthesis cap (8) and proximal femoral trunk (5) contain a uniform convector to connect the support nails (10) of various diameters and lengths to the trunk.

4. A hip prosthesis system mentioned in Claim 1 and is characterised in that; containing tissue holes (6) that allow tendons to be attached.

5. A hip prosthesis system mentioned in Claim 1 and is characterised in that; containing a hip prosthesis connector region (9) used for joining more than one prosthesis piece in cases where bone tissue loss is more than the product dimensions.

6. A hip prosthesis system mentioned in Claim 1 and is characterised in that; containing a segment (3) that provides fixation with a liner in bipolar cups (1) in hip prosthesis systems.

7. A hip prosthesis system mentioned in Claim 1 and is characterised in that; containing a wear plate (2) that connects the head (4) part and the bipolar cup (1) and prevents possible friction.

8. A bipolar cup (1) mentioned in claim 1 and is characterised in that; it is composed of chrome cobalt material.

9. An acetabulum (12) mentioned in claim 1 and is characterised in that; it is composed of chrome cobalt material.

10. The invention is the application method of the bipolar hip prosthesis system used to treat the deformation in the femoral and acetabulum bones in the hip joints, and is characterised in that; including these operation steps:

- the damaged bone is cut and removed,

- the proximal femoral trunk (5) is fixed at the ideal angle and position. - the proximal femoral trunk (5) is attached to the connector part located in the hip prosthesis connector region (9) and the hip prosthesis cap (8) is tightened with bolts (7).

- the head (4) is driven into the proximal femoral trunk (5).

- the wear plate (2) is driven into the bipolar cup (1) and fixed with the segment (3). The prepared system is placed on the head (4). finally, the system is placed in the acetabulum (12) region by the physician.

11. The invention is the application method of the total hip prosthesis system used to treat the deformation in the femoral and acetabulum bones in the hip joints, and is characterised in that; including these operation steps:

- the damaged bone is cut and removed.

The support nail (10) belonging to the hip prosthesis systems is driven into the femur bone and fixed.

- the proximal femoral trunk (5) is fixed at the ideal angle and position.

- the head (4) is driven into the proximal femoral trunk (5).

- the part of the acetabulum (12) in total hip prosthesis is nailed to the head (4). finally, the hip bone cavity is excavated, and the acetabulum (12) part is fitted by the physician.