阅读说明：本技术 股骨柄假体及其制造方法 (Femoral stem prosthesis and method of making same ) 是由 贾海涛 童西平 吴梦飞 梁涛 张纪锋 于 2019-10-25 设计创作，主要内容包括：本发明提供了一种股骨柄假体及其制造方法,涉及医用假体技术领域,以解决现有金属制成的股骨柄容易松动、容易屈服和断裂的技术问题。股骨柄假体由多层润过PEEK浆液的碳纤维层铺设制成；每层碳纤维层内均包括多条长碳纤维,且股骨柄假体内的长碳纤维的走向与骨纤维的走向相同。该制造方法包括：将长碳纤维丝编织成碳纤维层；将碳纤维层浸润掺杂有短碳纤维的PEEK浆液；将多层碳纤维层层叠铺设于模具中；模具对多层碳纤维层进行固化。本发明的技术方案能够防止该股骨柄假体发生松动,使股骨柄假体具有各向异性的特点,能够承受多个方向的载荷,不易屈服和断裂,延长了股骨柄假体的使用寿命。(The invention provides a femoral stem prosthesis and a manufacturing method thereof, relates to the technical field of medical prostheses, and aims to solve the technical problems that a femoral stem made of the existing metal is easy to loosen, yield and break. The femoral stem prosthesis is prepared by laying a plurality of carbon fiber layers which are wet by PEEK slurry; each layer of carbon fiber layer comprises a plurality of long carbon fibers, and the direction of the long carbon fibers in the femoral stem prosthesis is the same as that of the bone fibers. The manufacturing method comprises the following steps: weaving long carbon fiber filaments into a carbon fiber layer; infiltrating the carbon fiber layer with PEEK slurry doped with short carbon fibers; laying a plurality of carbon fiber layers in a mold in a laminated manner; the mold is used for curing the plurality of carbon fiber layers. The technical scheme of the invention can prevent the femoral stem prosthesis from loosening, so that the femoral stem prosthesis has the characteristic of anisotropy, can bear loads in multiple directions, is not easy to yield and break, and prolongs the service life of the femoral stem prosthesis.)

1. The femoral stem prosthesis is characterized in that the femoral stem prosthesis is formed by laying a plurality of carbon fiber layers soaked by PEEK slurry;

each layer of the carbon fiber layer comprises a plurality of long carbon fibers, and the direction of the long carbon fibers in the femoral stem prosthesis is the same as the direction of the bone fibers.

2. The femoral stem prosthesis of claim 1, wherein short carbon fibers are filled between adjacent carbon fiber layers.

3. The femoral stem prosthesis of claim 1, wherein the long carbon fibers in each carbon fiber layer are staggered and oriented in the same direction as the bone fibers.

4. The femoral stem prosthesis of claim 1, wherein the long carbon fibers in the same carbon fiber layer all extend in the same direction;

after the plurality of carbon fiber layers are laid in a stacked mode, long carbon fibers in different carbon fiber layers are arranged in a staggered mode according to the trend of bone fibers.

5. The femoral stem prosthesis according to claim 1, comprising a first long carbon fiber extending from the conical head (10) to the distal end (40) throughout the femoral stem prosthesis forming a "Sichuan" shaped running streak.

6. The femoral stem prosthesis of claim 5, further comprising a second long carbon fiber arranged from the proximal end (30) to the distal end (40) forming a '╭' shaped running water-like stripe.

7. The femoral stem prosthesis according to claim 6, further comprising a third long carbon fiber arranged from the conical head (10) to the proximal end (30) forming a water-flowing stripe shaped as "".

8. The femoral stem prosthesis according to claim 7, wherein the long carbon fibers at the conical head (10) and the neck (20) form a net structure of interweaving 'chuan' and ''.

9. The femoral stem prosthesis according to claim 7, wherein the long carbon fibers at the proximal end (30) form an interwoven mesh structure of "Sichuan", "" and "╭".

10. The femoral stem prosthesis according to claim 6 or 7, wherein the long carbon fibers at the proximal end (30) to the distal end (40) form a net structure interweaving in a "Sichuan" shape and a "╭" shape.

11. A method of manufacturing a femoral stem prosthesis according to any one of claims 1 to 10, comprising:

weaving long carbon fiber filaments into a carbon fiber layer;

infiltrating the carbon fiber layer with PEEK slurry doped with short carbon fibers;

laying a plurality of carbon fiber layers in a mold in a laminated manner;

the mold is used for curing the plurality of carbon fiber layers.

Technical Field

The invention relates to the technical field of medical prostheses, in particular to a femoral stem prosthesis and a manufacturing method thereof.

Background

The prosthesis is called a prosthesis in medicine, and is a medical appliance for replacing a certain limb, organ or tissue of a human body. In the field of femoral stem prosthesis, metal materials are mostly adopted for manufacturing, but because the elastic modulus of metal is generally much larger than that of human bones, stress shielding is easy to occur, and the femoral stem bears more load, so that the prosthesis is loosened. In addition, the metal material is an isotropic material, which is not advantageous when it is subjected to a load having a significant directionality, and generally causes phenomena such as fracture, yielding, buckling, and instability.

Disclosure of Invention

The invention aims to provide a femoral stem prosthesis and a manufacturing method thereof, which aim to solve the technical problems that a femoral stem made of the existing metal is easy to loosen, yield and break.

In a first aspect, the invention provides a femoral stem prosthesis, which is made by laying a plurality of carbon fiber layers infiltrated with PEEK slurry;

each layer of the carbon fiber layer comprises a plurality of long carbon fibers, and the direction of the long carbon fibers in the femoral stem prosthesis is the same as the direction of the bone fibers.

With reference to the first aspect, in a first possible implementation manner of the first aspect, short carbon fibers are filled between adjacent carbon fiber layers.

With reference to the first aspect, in a second possible implementation manner of the first aspect, the long carbon fibers in each carbon fiber layer are arranged in a staggered manner, and the direction of the long carbon fibers in each carbon fiber layer is the same as the direction of the bone fibers.

With reference to the first aspect, in a third possible implementation manner of the first aspect, the long carbon fibers in the same carbon fiber layer all extend in the same direction;

after the plurality of carbon fiber layers are laid in a stacked mode, long carbon fibers in different carbon fiber layers are arranged in a staggered mode according to the trend of bone fibers.

With reference to the first aspect, in a fourth possible implementation manner of the first aspect, the femoral stem prosthesis includes first long carbon fibers, and the first long carbon fibers extend from the conical head to the distal end and penetrate through the femoral stem prosthesis to form a "river" shaped flowing stripe.

With reference to the fourth possible implementation manner of the first aspect, in a fifth possible implementation manner of the first aspect, the femoral stem prosthesis further includes a second long carbon fiber, and the second long carbon fiber is arranged from the proximal end to the distal end to form a "╭" shaped flowing water-like stripe.

With reference to the fifth possible implementation manner of the first aspect, in a sixth possible implementation manner of the first aspect, the femoral stem prosthesis further includes a third long carbon fiber, and the third long carbon fiber is arranged from the conical head to the proximal end to form a "" shaped flowing water-like stripe.

With reference to the sixth possible implementation manner of the first aspect, in a seventh possible implementation manner of the first aspect, the long carbon fibers at the conical head and the neck portion form a mesh structure in which a "river" shape and a "" shape are interwoven.

In combination with the sixth possible implementation manner of the first aspect, in an eighth possible implementation manner of the first aspect, the long carbon fibers at the proximal end form an interwoven mesh structure of a "chuan" shape, a "" shape, and a "╭" shape.

With reference to the fifth or sixth possible implementation manner of the first aspect, in a ninth possible implementation manner of the first aspect, the long carbon fibers from the proximal end to the distal end form a mesh structure in which a "river" shape and a "╭" shape are interwoven.

In a second aspect, the present invention also provides a method of manufacturing a femoral stem prosthesis as described above, comprising:

weaving long carbon fiber filaments into a carbon fiber layer;

infiltrating the carbon fiber layer with PEEK slurry doped with short carbon fibers;

laying a plurality of carbon fiber layers in a mold in a laminated manner;

the mold is used for curing the plurality of carbon fiber layers.

By combining the technical scheme, the beneficial effects brought by the invention are analyzed as follows:

the femoral stem prosthesis provided by the invention is prepared by laminating and laying a plurality of carbon fiber layers soaked with PEEK slurry, each carbon fiber layer comprises a plurality of long carbon fibers, and the direction of the long carbon fibers in the femoral stem prosthesis is the same as that of the bone fibers. The carbon fiber layer soaked by the PEEK slurry forms a carbon fiber reinforced PEEK material, has the elastic modulus equivalent to that of human skeleton, does not have the stress shielding problem, can prevent the femoral stem prosthesis from loosening, and prolongs the service life of the femoral stem prosthesis. Meanwhile, the direction of the long carbon fibers in the femoral stem prosthesis is the same as that of the bone fibers, so that the femoral stem prosthesis has the characteristic of anisotropy, can bear loads in multiple directions, has better performances such as compression resistance, bending resistance, tensile resistance, torsion resistance and shear resistance, is not easy to yield and fracture, has better matching performance with bone tissues, and further prolongs the service life of the femoral stem prosthesis. Meanwhile, the femoral stem prosthesis is made of PEEK material and carbon fiber material, so that the femoral stem prosthesis has higher biological safety, and a patient using the femoral stem prosthesis cannot generate metal anaphylactic reaction.

The invention also provides a manufacturing method of the femoral stem prosthesis, which comprises the following steps: weaving long carbon fiber filaments into a carbon fiber layer; infiltrating the carbon fiber layer with PEEK slurry doped with short carbon fibers; laying a plurality of carbon fiber layers in a mold in a laminated manner; the mold is used for curing the plurality of carbon fiber layers. The elastic modulus of the femoral stem prosthesis manufactured by the manufacturing method is equivalent to that of human skeleton, the problem of stress shielding can not occur, the femoral stem prosthesis can be prevented from loosening, and the service life of the femoral stem prosthesis is prolonged. Meanwhile, the femoral stem prosthesis with the same direction of the long carbon fibers and the bone fibers can be obtained by the method, the femoral stem prosthesis has the characteristic of anisotropy, can bear loads in multiple directions, has good performances such as compression resistance, bending resistance, tensile resistance, torsion resistance and shear resistance, is not easy to yield and break, has better matching performance with bone tissues, and further prolongs the service life of the femoral stem prosthesis. Meanwhile, the femoral stem prosthesis is made of PEEK material and carbon fiber material, so that the femoral stem prosthesis has higher biological safety, and a patient using the femoral stem prosthesis cannot generate metal anaphylactic reaction.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

FIG. 1 is an elevational view, in cross-section, of a femoral stem prosthesis provided in accordance with an embodiment of the present invention;

FIG. 2 is an enlarged view of a portion of the upper portion of FIG. 1;

FIG. 3 is a side cross-sectional view of a femoral stem prosthesis provided in accordance with an embodiment of the present invention;

fig. 4 is a partially enlarged view of the upper portion of fig. 3.

Icon: 10-cone head; 20-neck part; 30-a proximal end; 40-distal end.

Detailed Description

The technical solutions of the present invention will be described clearly and completely with reference to the following embodiments, and it should be understood that the described embodiments are some, but not all, embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

In the description of the present invention, it should be noted that the terms "upper", "lower", "inside", "outside", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience in describing the present invention and simplifying the description, but do not indicate or imply that the referred device or element must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, should not be construed as limiting the present invention.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted" and "connected" are to be interpreted broadly, e.g., as being either fixedly connected, detachably connected, or integrally connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

The embodiment of the invention provides a femoral stem prosthesis, and please refer to fig. 1 to 4 in the attached drawings of the specification together.

Fig. 1 is a front cross-sectional view of a femoral stem prosthesis according to an embodiment of the present invention; FIG. 2 is an enlarged view of a portion of the upper portion of FIG. 1; FIG. 3 is a side cross-sectional view of a femoral stem prosthesis provided in accordance with an embodiment of the present invention; fig. 4 is a partially enlarged view of the upper portion of fig. 3.

As shown in fig. 1 and 3, the femoral stem prosthesis has a conical head 10, a neck 20, a proximal end 30 and a distal end 40.

The femoral stem prosthesis is prepared by laying a plurality of carbon fiber layers soaked with PEEK (polyetheretherketone) slurry, and the carbon fiber layers soaked with the PEEK slurry form a carbon fiber reinforced PEEK material, so that the femoral stem prosthesis has the elasticity modulus equivalent to that of human bones, the stress shielding problem can not occur, the femoral stem prosthesis can be prevented from loosening, and the service life of the femoral stem prosthesis is prolonged.

Every layer of carbon fiber layer all includes many long carbon fiber, and the long carbon fiber's in the femoral stem false body trend is the same with the fibrous trend of bone, can bear the load of a plurality of directions, has better resistance to compression, bending-resistant, tensile, antitorque, shear resistance performance etc. the difficult condition of surging and fracture that takes place, and is better with the matching performance of bone tissue, has further prolonged the life of femoral stem false body.

In addition, the femoral stem prosthesis made of metal can release metal ions in a human body, and can cause allergic reaction of part of the human body. The femoral stem prosthesis is made of PEEK material and carbon fiber material, free metal ions are not generated, the femoral stem prosthesis has higher biological safety, and a patient using the femoral stem prosthesis cannot generate metal anaphylactic reaction.

Referring to fig. 3 and 4, short carbon fibers are filled between adjacent carbon fiber layers, and the short carbon fibers enhance the shearing strength between the adjacent carbon fiber layers, so that the femoral stem prosthesis has strong shearing resistance and can bear large shearing force.

During the process of specifically manufacturing the femoral stem prosthesis, the woven carbon fiber layers are soaked in the PEEK slurry doped with the short carbon fibers, then the plurality of carbon fiber layers are laid in the mold, the mold is used for curing the plurality of carbon fiber layers, and the short carbon fibers are arranged between the adjacent carbon fiber layers.

The arrangement of the long carbon fibers in the carbon fiber layer is classified into the following two cases.

The first is that the long carbon fibers in each carbon fiber layer are arranged in a staggered manner, and the direction of the long carbon fibers in each carbon fiber layer is the same as the direction of the bone fibers.

When the carbon fiber layers are manufactured according to the arrangement mode of the long carbon fibers, long fibers in each carbon fiber layer are woven into a net according to bone fibers, the femoral stem prosthesis is formed by mold fixation, and the formed femoral stem prosthesis has the characteristic of anisotropy, can bear loads in multiple directions such as compression resistance, bending resistance, tensile resistance, torsion resistance, shear resistance and the like, has better matching performance with bone tissues, and prolongs the service life of the femoral stem prosthesis.

Secondly, the long carbon fibers in the same carbon fiber layer extend along the same direction; after the plurality of carbon fiber layers are laid in a stacked mode, long carbon fibers in different carbon fiber layers are arranged in a staggered mode according to the trend of bone fibers.

When the carbon fiber layer is manufactured according to the arrangement mode of the long carbon fibers, long fibers in the same carbon fiber layer are placed in the same direction, a fiber net which is the same with the bone fiber in the running direction is formed after the plurality of layers of carbon fiber layers are laid in a mold, the femoral stem prosthesis is formed through mold fixation, the formed femoral stem prosthesis has the characteristic of anisotropy, can bear loads in multiple directions such as compression resistance, bending resistance, tensile resistance, torsion resistance and shearing resistance, the matching performance with bone tissues is better, and the service life of the femoral stem prosthesis is prolonged.

The orientation of the long carbon fibers in the femoral stem prosthesis is the same as the orientation of the bone fibers, and in particular, the orientation and distribution of the long carbon fibers in the femoral stem prosthesis at the awl head 10, the neck 20, the proximal end 30, and the distal end 40 are described in detail below.

Referring to fig. 1 and 2, the femoral stem prosthesis includes a first long carbon fiber, and a plurality of first long carbon fibers extend from the conical head 10 to the distal end 40, and penetrate through the femoral stem prosthesis to form a "river" shaped flowing stripe, so that the femoral stem prosthesis can bear a large pulling force.

Referring to fig. 1 and 2, the femoral stem prosthesis further includes a second long carbon fiber, and a plurality of the second long carbon fibers are arranged from the proximal end 30 to the distal end 40 to form a water-flowing stripe in the shape of '╭', so that the femoral stem has stronger compression, bending and torsion resistances between the proximal end 30 and the distal end 40.

With continued reference to fig. 1 and 2, the femoral stem prosthesis further includes a third plurality of long carbon fibers arranged from the tip 10 to the proximal end 30 to form a water-flowing stripe in the shape of "", thereby providing the femoral stem prosthesis with strong compression, bending and torsion resistance between the tip 10 and the tip.

Referring to fig. 1 and 2, the cone head 10 and the neck 20 have a plurality of first long carbon fibers and a plurality of third long carbon fibers, so that the long carbon fibers at the cone head 10 and the neck 20 form a net structure interwoven in a shape of "chuan" and "", thereby ensuring that the cone head 10 and the neck 20 have strong tensile, compressive, bending and torsional resistance and can bear loads in various directions.

Referring to fig. 1 and 2, both the first long carbon fibers and the second long carbon fibers are arranged at the positions from the proximal end 30 to the distal end 40, and then the long carbon fibers at the positions from the proximal end 30 to the distal end 40 form a net structure formed by interweaving a "river" shape and a "╭" shape, so that the positions from the proximal end 30 to the distal end 40 have strong tensile, compressive, bending and torsional capabilities, and can bear loads in all directions.

The femoral stem prosthesis is relatively complex and subject to significant loads at the proximal end 30 when in the human body. To enable the proximal end 30 of the femoral stem prosthesis to withstand large and complex loads. Referring to fig. 1 and 2, the first long carbon fibers, the second long carbon fibers and the third long carbon fibers are disposed at the proximal end 30, so that the long carbon fibers at the proximal end 30 form a net structure formed by interweaving a shape of "chuan", "" and "╭", thereby ensuring that the proximal end 30 has strong tensile, compressive, bending and torsional resistance, and can bear large and complex loads in various directions.

Embodiments of the present invention also provide a method of manufacturing the femoral stem prosthesis, the method including the steps of:

weaving long carbon fiber filaments into a carbon fiber layer;

infiltrating the carbon fiber layer with PEEK slurry doped with short carbon fibers;

laying a plurality of carbon fiber layers in a mold in a laminated manner;

the mold is used for curing the plurality of carbon fiber layers.

The elastic modulus of the femoral stem prosthesis manufactured by the manufacturing method is equivalent to that of human skeleton, the problem of stress shielding can not occur, the femoral stem prosthesis can be prevented from loosening, and the service life of the femoral stem prosthesis is prolonged.

When the long carbon fibers are woven into the carbon fiber layer, there are two cases of arranging the long carbon fibers.

In the first case, the long carbon fibers in each carbon fiber layer are arranged in a staggered manner, and the direction of the long carbon fibers in each carbon fiber layer is the same as the direction of the bone fibers.

In the second case, the long carbon fibers in the same carbon fiber layer extend along the same direction, and after the plurality of carbon fiber layers are stacked and laid, the long carbon fibers in different carbon fiber layers are arranged in a staggered manner according to the trend of the bone fibers.

No matter whether the first condition or the second condition is adopted when the long carbon fiber is woven into the carbon fiber layer, after the mold is used for curing the multi-layer carbon fiber layer, the femoral stem prosthesis with the same trend of the long carbon fiber and the bone fiber is obtained by demolding, so that the femoral stem prosthesis has the characteristic of anisotropy, can bear loads in multiple directions, has the performances of better compression resistance, bending resistance, tensile resistance, torsion resistance, shearing resistance and the like, is not easy to yield and fracture, has better matching performance with bone tissues, and further prolongs the service life of the femoral stem prosthesis. Meanwhile, the femoral stem prosthesis is made of PEEK material and carbon fiber material, so that the femoral stem prosthesis has higher biological safety, and a patient using the femoral stem prosthesis cannot generate metal anaphylactic reaction.

Finally, it should be noted that: the above examples are only intended to illustrate the technical solution of the present invention, but not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.