CN215228294U

CN215228294U - Degradable metal internal fixation cable

Info

Publication number: CN215228294U
Application number: CN202121425796.7U
Authority: CN
Inventors: 李岩; 何东磊
Original assignee: Yantai Haoyi Biotechnology Co ltd
Current assignee: Yantai Haoyi Biotechnology Co ltd
Priority date: 2021-06-25
Filing date: 2021-06-25
Publication date: 2021-12-21
Anticipated expiration: 2031-06-25

Abstract

The utility model relates to a medical implant technical field provides a degradable metal internal fixation cable. The method comprises the following steps: a cable body and a fixed end; wherein one end of the cable body is connected with the fixed end; the cable body is one of a single-strand wire cable, a double-strand wire cable or a flat ribbon cable; when the cable body is a single-strand wire cable or a double-strand wire cable, more than two circular through holes are formed in the fixed end; when the cable body is a flat ribbon cable, more than two rectangular through holes are arranged on the fixed end; the single-strand filamentous cable rope, the double-strand filamentous cable rope, the flat ribbon cable rope and the fixed end are made of degradable materials. The beneficial effects of the utility model reside in that: the fixing cable is made of degradable materials, particularly magnesium alloy, so that the effect of stress shielding on the healing of bone tissues in the implantation process can be effectively reduced or avoided; in addition, the magnesium alloy promotes bone repair after degradation, and shortens the recovery time of patients.

Description

Degradable metal internal fixation cable

Technical Field

The utility model relates to an orthopedic implant technical field, concretely relates to degradable metal internal fixation cable.

Background

The cable binding and fixing system widely applied in clinic at present is made of stainless steel or titanium alloy, and the cable binding and fixing system is mainly used for binding and fixing after fracture. The stainless steel and the titanium alloy have the advantages of high strength, good processing performance, high biocompatibility and the like, can meet the bearing force required by clinical use, and are the orthopedic implant materials widely used in clinic at present. However, they also have some problems in use, such as mechanical properties far higher than those of human bone tissues, causing stress shielding effect, causing bone tissue loss and the like to affect the healing of bone tissues. In addition, the stainless steel material is easy to break in the implantation process and after implantation, which leads to implantation failure or fixation failure and brings health risks to patients. Although these problems can be controlled to a certain extent by the optimisation of the material properties and the manipulation in clinical use, these materials present a difficult problem to solve, they are not degradable and eventually require a second surgical removal, which undoubtedly puts a great psychological and economic stress on the patient.

With the development and application of degradable materials in clinic, some researchers develop degradable polylactic acid bundling systems, which can solve the problem of secondary operation in clinic. However, the degradation of the polymer can generate a local acidic environment, which is not beneficial to the growth and healing of bone tissues, in addition, the mechanical property of the polylactic acid is poor, the stability is insufficient, and the use requirement of the part with a slight bearing requirement is difficult to meet, so the application of the polymer cable system is greatly limited.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide a degradable metal internal fixation cable to solve the problem that exists among the prior art.

In order to achieve the above object, the utility model adopts the following technical scheme: a degradable metallic internal fixation cable comprising: a cable body and a fixed end; wherein one end of the cable body is connected with the fixed end; the cable body is one of a single-strand wire cable, a double-strand wire cable or a flat ribbon cable; when the cable body is a single-strand wire cable or a double-strand wire cable, more than two circular through holes are formed in the fixed end; when the cable body is a flat ribbon cable, more than two rectangular through holes are arranged on the fixed end; the single-strand filamentous cable rope, the double-strand filamentous cable rope, the flat ribbon cable rope and the fixed end are made of degradable materials.

In an alternative embodiment, the degradable material is one of pure magnesium, magnesium alloy, pure zinc, zinc alloy, pure iron or iron alloy.

In an optional embodiment, the magnesium alloy is one of a magnesium-zinc alloy, a magnesium-calcium alloy, a magnesium-manganese alloy, a magnesium-rare earth alloy, a magnesium-strontium alloy, a magnesium-gallium alloy, a magnesium-lithium alloy, a magnesium-copper alloy or a magnesium-silver alloy; the zinc alloy is one of zinc-magnesium alloy, zinc-calcium alloy, zinc-copper alloy, zinc-strontium alloy, zinc-manganese alloy, zinc-silver alloy, zinc-iron alloy or zinc-gallium alloy; the iron alloy is one of iron-manganese alloy, iron-gallium alloy, iron-tungsten alloy, iron-carbon alloy, iron-zinc alloy, iron-boron alloy, iron-silicon alloy or iron-nitrogen alloy.

In an alternative embodiment, the cable body and the securing end are integrally formed.

In an optional embodiment, when the cable body is a bifilar filiform cable, the other end of the cable body is sleeved with a tip, and the edge of a duct of the tip and all outer peripheral lines adopt fillet transition; the end head is the same as the fixed end and the cable body in material.

In an alternative embodiment, when the cable body is a bifilar wire cable, the end of the cable body is provided with a welding zone, and the welding zone is one of arc welding, plasma welding, brazing or laser welding.

In an optional embodiment, the fixed end is a cuboid block structure, and all edges of the fixed end adopt fillet transition.

In an alternative embodiment, the rounded corners of the rectangular through-hole match the shape of the flat ribbon cable.

In an optional embodiment, the inner wall of the rectangular through hole or the circular through hole of the fixed end is provided with a thread or convex point anti-skid structure; the peripheral lines of the rectangular through hole or the circular through hole of the fixed end are in fillet transition.

In an alternative embodiment, the fixed end is plastically deformable under an external force.

The beneficial effects of the utility model reside in that:

(1) the utility model provides a hawser body of degradable metal internal fixation cable encircles behind the fixed part, the hawser body alternates a plurality of through-holes of stiff end repeatedly, force stiff end plastic deformation through external force at last and realize the clamp tight to its inside hawser body, finally realize the fixed of cable system, the filament processing that can solve traditional fixed cable effectively is difficult, cable system structure is complicated, with high costs scheduling problem, this cable appearance simple structure, high durability and convenient use, it is fixed firm, can realize that the cable is effectively fixed for a long time, ensure the restoration healing of fixed part bone tissue.

(2) The mooring rope body, the fixed end and the end head of the degradable metal internal fixing cable rope in the utility model are all made of degradable materials, especially magnesium alloy, the mechanical property of the cable rope is close to that of human bone tissue, and the healing of the bone tissue influenced by the stress shielding effect in the implantation process can be effectively reduced or avoided; in addition, the cable fixing system can be completely degraded in vivo, so that economic pressure and psychological burden of a patient caused by taking out an implant through a secondary operation can be avoided, particularly, the magnesium alloy has the effect of promoting bone repair after being degraded, and the recovery time of the patient is shortened.

Drawings

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

Fig. 1 is a schematic cross-sectional structure view of a single-strand wire rope and a double-strand wire rope according to an embodiment of the present invention.

Fig. 2 is a schematic cross-sectional view of a flat ribbon cable according to an embodiment of the present invention.

Fig. 3 is a schematic view of an end structure according to an embodiment of the present invention.

Fig. 4 is a schematic view of the overall structure of a flat ribbon cable according to another embodiment of the present invention.

Fig. 5 is a schematic view of a flat ribbon cable according to another embodiment of the present invention in use.

Fig. 6 is a schematic view of the overall structure of a single-stranded wire rope according to another embodiment of the present invention.

Fig. 7 is a schematic view of a single-strand wire rope according to another embodiment of the present invention.

Wherein, the reference numbers in the figures are: 1. single strand filiform hawser, 2, double strand filiform hawser, 3, flat banded hawser, 4, end, 5, stiff end, 6, rectangle through-hole, 7, circular through-hole.

Detailed Description

In order to make the technical problem, technical solution and advantageous effects to be solved by the present invention more clearly understood, the following description is given in conjunction with the accompanying drawings and embodiments to illustrate the present invention in further detail. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the invention.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly or indirectly secured to the other element. When an element is referred to as being "connected to" another element, it can be directly or indirectly connected to the other element. The terms "upper", "lower", "left", "right", "front", "rear", "vertical", "horizontal", "top", "bottom", "inner", "outer", and the like indicate orientations or positions based on the orientations or positions shown in the drawings, and are for convenience of description only and not to be construed as limiting the technical solution. The terms "first", "second" and "first" are used merely for descriptive purposes and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features. The meaning of "plurality" is two or more unless specifically limited otherwise.

Referring to fig. 1-7, the present embodiment provides a degradable metal internal fixation cable, comprising: a cable body and a fixed end 5; wherein, one end of the cable body is connected with the fixed end 5, preferably, the cable body and the fixed end 5 are integrally formed; the cable body is one of a single-strand filamentous cable 1, a double-strand filamentous cable 2 or a flat ribbon cable 3; when the cable body is a single-strand wire cable 1 or a double-strand wire cable 2, more than two circular through holes 7 are arranged on the fixed end 5; when the cable body is a flat ribbon cable 3, more than two rectangular through holes 7 are arranged on the fixed end 5; the single-strand filamentous cable 1, the double-strand filamentous cable 2, the flat ribbon cable 3 and the fixed end 5 are made of degradable materials.

It is noted that the degradable material is one of pure magnesium, magnesium alloy, pure zinc, zinc alloy, pure iron or iron alloy. Preferably, the magnesium alloy is one of magnesium-zinc alloy, magnesium-calcium alloy, magnesium-manganese alloy, magnesium-rare earth alloy, magnesium-strontium alloy, magnesium-gallium alloy, magnesium-lithium alloy, magnesium-copper alloy or magnesium-silver alloy; the zinc alloy is one of zinc-magnesium alloy, zinc-calcium alloy, zinc-copper alloy, zinc-strontium alloy, zinc-manganese alloy, zinc-silver alloy, zinc-iron alloy or zinc-gallium alloy; the iron alloy is one of iron-manganese alloy, iron-gallium alloy, iron-tungsten alloy, iron-carbon alloy, iron-zinc alloy, iron-boron alloy, iron-silicon alloy or iron-nitrogen alloy. When the cable body is a bifilar filamentous cable 2, the other end of the cable body is sleeved with an end head 4, and the edges of the pore channels of the end head 4 and all the outer peripheral lines adopt fillet transition; the end 4, the fixed end 5 and the cable body are made of the same material, and particularly when the degradable material is magnesium alloy, the mechanical property of the degradable material is close to that of human bone tissues, so that the effect of stress shielding on the healing of the bone tissues in the implantation process can be effectively reduced or avoided; in addition, the cable fixing system can be completely degraded in vivo, so that economic pressure and psychological burden of a patient caused by taking out an implant through a secondary operation can be avoided, particularly, the magnesium alloy has the effect of promoting bone repair after being degraded, and the recovery time of the patient is shortened. Further, when the cable body is the bifilar filamentous cable 2, the tail end of the cable body is provided with a welding area, the welding mode of the welding area is one of arc welding, plasma welding, brazing or laser welding, the cable is prevented from being loose, the welding area is located at the tail end of the cable weaving section, the tail end of the cable is welded after being woven, the function of the welding area is the same as that of the end head 4, and the welding area and the end head are all prevented from being loose during weaving.

In addition, stiff end 5 is cuboid massive structure, and all sidelines of stiff end 5 adopt the fillet transition, and the fillet of rectangle through-hole 6 matches with the shape of flat ribbon hawser 3. The inner wall of the rectangular through hole 6 or the circular through hole 7 of the fixed end 5 is provided with a thread or convex point anti-skid structure; the peripheral lines of the rectangular through hole 6 or the circular through hole 7 of the fixed end 5 are in fillet transition. It is worth mentioning that the fixed end 5 is plastically deformable under the action of an external force. After the hawser body encircleed the fixed part, the hawser body alternates a plurality of through-holes of stiff end repeatedly, forces stiff end plastic deformation to realize the clamp tightly to its inside hawser body through external force at last, finally realizes the fixed of cable system, can solve the filament processing difficulty of traditional fixed cable effectively, cable system structure complicacy, problem such as with high costs, this cable appearance simple structure, convenient to use, fixed firm, can realize that the cable is effectively fixed for a long time, ensure the restoration healing of fixed part bone tissue.

The first embodiment is as follows: scapular glenoid fracture degradable metal cable fixing system

The fixation system in this example was constructed as shown in fig. 5 and was made of degradable medical grade pure magnesium (99.99 wt.%).

Prior to surgery, the cable is first passed through a pre-drilled hole in the bone tissue (in all embodiments pre-drilled holes are pre-drilled holes in the bone tissue through which the cable is passed), bone screws or needles are passed back to the cable retaining segment, the cable is tightened with a tightener, the cable extension is sleeved with a clamping buckle, and the fixing buckle is clamped with clamping pliers.

The mechanical property of the cable is subjected to tensile test by adopting a long gauge length according to a room temperature test method of part 1 of a GB/T228.1-2010 metal material tensile test, and the actually measured tensile strength of the cable is 220MPa, and the breaking elongation is 14.3%. Elastic modulus the cable measured the elastic modulus 42.3GPa according to the experimental methods of GB/T22315 metal material elastic modulus and Poisson ratio. In vitro degradation Testing was performed in accordance with ASTM G31-2016Standard Practice for Laboratory imaging calibration of Metals, in accordance with GB/T16545-. The experiment adopts simulated body fluid as a soaking medium, the soaking period is 28 days, and the degradation rate of the cable in the simulated body fluid is 0.15 mm/y. The in vitro cell experiment conforms to GB/T16886.5-2017 in vitro cytotoxicity experiment, an MTT method is adopted, the leaching ratio is 1.25cm2/ml, MC3T3 cells and alpha-MEM containing 10% fetal calf serum are adopted for culture and the experiment is carried out, the relative proliferation rate of the detected cells is 99%, and the toxicity reaction is grade 0. After the implantation, the full degradation period of the cable fixing system is 16 months, the fracture healing is good, and the loosening and falling do not occur in the healing process.

Example two: degradable metal cable fixing system for scaphoid fracture

The fixing system in this embodiment is shown in fig. 7, and the system is made of degradable medical AZ31 magnesium alloy.

During the operation, the cable is passed through the pre-drilled hole in the bone tissue, bone screw or needle, the cable is passed back to the cable fixing section, the cable is tightened with tightener, the extended part of the cable is covered with clamping buckle, and the fixing buckle is clamped with clamping pliers.

The mechanical property of the cable is subjected to tensile test by adopting a long gauge length according to a room temperature test method of part 1 of a GB/T228.1-2010 metal material tensile test, and the actually measured tensile strength of the cable is 274MPa and the breaking elongation is 10.6%. Elastic modulus the cable measured an elastic modulus of 44.5GPa according to the experimental methods for the elastic modulus and Poisson ratio of GB/T22315 metal materials. In vitro degradation Testing was performed in accordance with ASTM G31-2016Standard Practice for Laboratory imaging calibration of Metals, in accordance with GB/T16545-. The experiment adopts simulated body fluid as a soaking medium, the soaking period is 28 days, and the degradation rate of the cable in the simulated body fluid is 0.17 mm/y. The in vitro cell experiment conforms to GB/T16886.5-2017 in vitro cytotoxicity experiment, adopts MTT method, the leaching ratio is 1.25cm2/ml, the experiment is carried out by adopting L929 cells and alpha-MEM containing 10% fetal calf serum, the relative proliferation rate of the detected cells is 89%, and the toxicity reaction is grade 1. After the implantation, the full degradation period of the cable fixing system is 15 months, the fracture healing is good, the loosening and falling do not occur in the healing process, and the adverse reaction does not occur.

The above description is only exemplary of the present invention and should not be taken as limiting the scope of the present invention, as any modifications, equivalents, improvements and the like made within the spirit and principles of the present invention are intended to be included within the scope of the present invention.

Claims

1. A degradable metallic internal fixation cable comprising: a cable body and a fixed end (5); wherein one end of the cable body is connected with the fixed end (5);

the method is characterized in that: the cable body is one of a single-strand filamentous cable (1), a double-strand filamentous cable (2) or a flat ribbon cable (3); when the cable body is a single-strand wire cable (1) or a double-strand wire cable (2), more than two circular through holes (7) are formed in the fixed end (5); when the mooring rope body is a flat ribbon mooring rope (3), more than two rectangular through holes (6) are formed in the fixed end (5); the single-strand filamentous cable rope (1), the double-strand filamentous cable rope (2), the flat ribbon cable rope (3) and the fixed end (5) are made of degradable materials.

2. The degradable metallic internal fixation cable of claim 1 wherein said degradable material is one of pure magnesium, magnesium alloy, pure zinc, zinc alloy, pure iron or iron alloy.

3. The degradable metallic internal fixation cable of claim 2, wherein said magnesium alloy is one of magnesium-zinc alloy, magnesium-calcium alloy, magnesium-manganese alloy, magnesium-rare earth alloy, magnesium-strontium alloy, magnesium-gallium alloy, magnesium-lithium alloy, magnesium-copper alloy or magnesium-silver alloy; the zinc alloy is one of zinc-magnesium alloy, zinc-calcium alloy, zinc-copper alloy, zinc-strontium alloy, zinc-manganese alloy, zinc-silver alloy, zinc-iron alloy or zinc-gallium alloy; the iron alloy is one of ferro-manganese alloy, ferro-tungsten alloy, ferro-carbon alloy, ferro-zinc alloy, ferro-boron alloy, ferro-silicon alloy or ferro-nitrogen alloy.

4. A degradable metal internal fixation cable as claimed in claim 1, wherein said cable body and fixation end (5) are integrally formed.

5. A degradable metal internal fixation cable as claimed in claim 4, wherein when said cable body is a bifilar filamentous cable (2), the other end of said cable body is sleeved with a terminal (4), the pore edge and all outer peripheral lines of said terminal (4) are rounded; the end head (4) and the fixed end (5) are made of the same material as the cable body.

6. A degradable metallic internal fixation cable as claimed in claim 4, wherein when said cable body is a bifilar wire cable (2), the end of said cable body is provided with a welding zone, said welding zone being one of arc welding, plasma welding, brazing or laser welding.

7. A degradable metal internal fixation cable as claimed in claim 1, wherein said fixation end (5) is a cuboid block structure, and all edges of said fixation end (5) are rounded.

8. A degradable metal internal fixation cable as claimed in claim 7, characterized in that the rounded corners of said rectangular through hole (6) match the shape of said flat ribbon cable (3).

9. A degradable metal internal fixation cable as claimed in claim 8, wherein the inner wall of the rectangular through hole (6) or the circular through hole (7) of said fixation end (5) is provided with a screw thread or a convex point anti-slip structure; the outer peripheral lines of the rectangular through holes (6) or the circular through holes (7) of the fixed end (5) are in fillet transition.

10. A degradable metal internal fixation cable as claimed in claim 1, wherein said fixation end (5) is plastically deformable under the action of external force.