CN117503427A - Fatigue-resistant ossicular prosthesis and processing method thereof - Google Patents
Fatigue-resistant ossicular prosthesis and processing method thereof Download PDFInfo
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- CN117503427A CN117503427A CN202311681525.1A CN202311681525A CN117503427A CN 117503427 A CN117503427 A CN 117503427A CN 202311681525 A CN202311681525 A CN 202311681525A CN 117503427 A CN117503427 A CN 117503427A
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- 238000001035 drying Methods 0.000 claims description 7
- 238000005498 polishing Methods 0.000 claims description 7
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 claims description 5
- 230000008569 process Effects 0.000 claims description 5
- 229910052719 titanium Inorganic materials 0.000 claims description 5
- 239000010936 titanium Substances 0.000 claims description 5
- GRYLNZFGIOXLOG-UHFFFAOYSA-N Nitric acid Chemical compound O[N+]([O-])=O GRYLNZFGIOXLOG-UHFFFAOYSA-N 0.000 claims description 3
- 229910017604 nitric acid Inorganic materials 0.000 claims description 3
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- 229910001220 stainless steel Inorganic materials 0.000 claims description 2
- 229910052715 tantalum Inorganic materials 0.000 claims description 2
- GUVRBAGPIYLISA-UHFFFAOYSA-N tantalum atom Chemical compound [Ta] GUVRBAGPIYLISA-UHFFFAOYSA-N 0.000 claims description 2
- 230000003746 surface roughness Effects 0.000 abstract description 20
- 230000002829 reductive effect Effects 0.000 abstract description 9
- 210000000959 ear middle Anatomy 0.000 abstract description 5
- 208000000781 Conductive Hearing Loss Diseases 0.000 abstract description 4
- 206010010280 Conductive deafness Diseases 0.000 abstract description 4
- 208000023563 conductive hearing loss disease Diseases 0.000 abstract description 4
- 230000000052 comparative effect Effects 0.000 description 46
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- OCKGFTQIICXDQW-ZEQRLZLVSA-N 5-[(1r)-1-hydroxy-2-[4-[(2r)-2-hydroxy-2-(4-methyl-1-oxo-3h-2-benzofuran-5-yl)ethyl]piperazin-1-yl]ethyl]-4-methyl-3h-2-benzofuran-1-one Chemical compound C1=C2C(=O)OCC2=C(C)C([C@@H](O)CN2CCN(CC2)C[C@H](O)C2=CC=C3C(=O)OCC3=C2C)=C1 OCKGFTQIICXDQW-ZEQRLZLVSA-N 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/18—Internal ear or nose parts, e.g. ear-drums
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/18—Internal ear or nose parts, e.g. ear-drums
- A61F2002/183—Ear parts
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- Health & Medical Sciences (AREA)
- Otolaryngology (AREA)
- Pulmonology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The invention discloses a fatigue-resistant ossicular prosthesis and a processing method thereof, comprising the following steps: performing ultrasonic cavitation water jet impact on the polished ossicle prosthesis; the ultrasonic power density of the ultrasonic cavitation water jet impact is 0.40W/cm 2 ～0.50W/cm 2 The water pressure of the ultrasonic cavitation water jet impact is 15 MPa-20 MPa. The surface residual compressive stress of the processed ossicular prosthesis is increased, the surface hardness is obviously improved, and the surface roughness is slightly reduced, so that the fatigue strength of the ossicular prosthesis is improved, the stability and the safety of the ossicular prosthesis are improved, and the ossicular prosthesis is suitable for performing replacement operation on all or part of ossicular chains of the middle ear and reconstructing a sound conduction chain when conductive hearing loss of a patient occurs.
Description
Technical Field
The invention belongs to the technical field of medical appliances, and particularly relates to a processing method of a fatigue-resistant ossicular prosthesis and the fatigue-resistant ossicular prosthesis obtained after processing.
Background
Ossicles, also known as ossicular chains, are important sound-transmitting tissue structures in the human ear. When sound waves are transmitted from the external auditory meatus, the vibrations of the eardrum are caused, which in turn cause vibrations of the ossicles through which sound is then transmitted into the cochlea.
When a patient produces conductive hearing loss due to middle ear lesions or ossicular damage and the like, a middle ear full or partial ossicular replacement operation needs to be performed, and a sound conduction chain is rebuilt. After the auditory ossicle prosthesis is implanted into the ear, the auditory ossicle prosthesis can be subjected to long-term effects of sound waves, eardrum, cochlea, human body activities and the like, generates alternating stress fatigue, is easy to cause damage to the auditory ossicle prosthesis, even has abnormal phenomena such as displacement or falling off, influences the stability and safety of the auditory ossicle prosthesis, causes hearing damage or loss of a patient, and brings serious influence to life.
Existing ossicular prostheses on the market are mostly developed by adopting different materials, different structures or different processes (machining, powder sintering, 3D printing and the like), however, few related documents or patents relate to a further processing or treatment method of small miniature parts which have high requirements on the performance (fatigue strength, fracture strength, surface hardness, surface roughness and the like) of the ossicular prostheses and are in direct contact with human tissues.
In the prior art, ultrasonic cavitation is widely applied in the fields of biomedicine, chemical production and the like. In the chemical industry field, at present, ultrasonic cavitation is more used for cleaning the outer surface of an object, and the ultrasonic power density needs to be large enough to achieve the aim of better surface strengthening cleaning; however, the greater the ultrasonic power density, the more severe the cavitation erosion of the part surface. Cavitation water jet is applied to the field of industrial production such as surface strengthening, but to achieve a good strengthening purpose, cavitation water pressure is generally up to tens of megapascals or impacts for a long time. Also, the greater the ultrasonic cavitation power density or cavitation water jet injection pressure, the more severe the cavitation erosion of the part surface. Cavitation corrosion can damage the surface integrity of the part, so that the surface roughness is increased, the surface residual compressive stress and the surface hardness are reduced, and the fatigue strength, the breaking strength and other mechanical properties and the service performance of the part are adversely affected.
Compared with the conventional metal parts, the medical ossicular prosthesis has the characteristics of small size (the thickness of a top plate of the prosthesis is only about 0.2mm, the diameter of the top plate is not more than 5mm, the diameter of a supporting rod is less than 0.5 mm), light weight (generally less than 50 mm), relatively complex outline (most of the top plates of the commercial ossicular prosthesis are hollowed out), and the like, so that a proper processing method is required to achieve the purposes of increasing the residual compressive stress of the surface of the ossicular prosthesis, improving the surface hardness of the ossicular prosthesis, reducing the surface roughness, improving the fatigue strength and other mechanical properties of the ossicular prosthesis, and further improving the stability and the safety of the product in the use process.
Disclosure of Invention
Based on the above, the invention aims to provide a fatigue-resistant ossicular prosthesis and a processing method thereof, which can not only reduce the surface roughness of the ossicular prosthesis, but also increase the surface residual compressive stress, improve the surface hardness of the ossicular prosthesis and strengthen the fatigue resistance.
The technical scheme for realizing the aim of the invention comprises the following steps.
In a first aspect of the invention, a method for processing a fatigue-resistant ossicular prosthesis is provided, comprising the following steps: performing ultrasonic cavitation water jet impact on the polished ossicle prosthesis; the ultrasonic power density of the ultrasonic cavitation water jet impact is 0.40W/cm 2 ～0.50W/cm 2 The water pressure of the ultrasonic cavitation water jet impact is 15 MPa-20 MPa.
In a second aspect of the invention, a fatigue-resistant ossicular prosthesis is provided, which is processed by the processing method.
According to the processing method of the fatigue-resistant ossicular prosthesis, ultrasonic cavitation and water jet impact are adopted for the first time, the polished ossicular prosthesis is processed at the same time, through reasonably setting relevant parameters of ultrasonic cavitation water jet (lower ultrasonic power density and lower jet water pressure and proper jet time and jet distance), the residual compressive stress on the surface of the processed ossicular prosthesis is obviously increased, the surface hardness is obviously improved, and the surface roughness is obviously reduced compared with a mechanically-formed prosthesis, so that the stability and the safety of the ossicular prosthesis are improved, and the processing method is suitable for performing replacement operation on all or part of auditory chains of a middle ear when conductive hearing loss of a patient is generated, and reconstructing a sound conductive chain.
Drawings
FIG. 1 is a schematic structural view of a fatigue-resistant ossicular prosthesis according to the present invention, wherein 11 is a top plate; 12 is a supporting rod; 13 is a base.
Fig. 2 is a process route diagram of a method of processing a fatigue-resistant ossicular prosthesis according to the present invention.
FIG. 3 is a schematic view of an ultrasonic cavitation water jet treatment device for processing a fatigue-resistant ossicle prosthesis according to the present invention; 1, an ultrasonic vibration mechanism; 2. a water jet injection mechanism; 3. an injection hole; 4. a cavitation tank; 5. deionized water; 6. cavitation bubbles; 7. a work table; 8. ossicular prostheses.
Fig. 4 is a surface topography (at 800 x magnification) of an auditory ossicle prosthesis of example 4 of the present invention.
Fig. 5 is a surface topography (at 800 x magnification) of an auditory ossicle prosthesis of comparative example 4 of the present invention.
Fig. 6 is a surface topography (at 800 x magnification) of an auditory ossicle prosthesis of comparative example 13 of the present invention.
Detailed Description
The present invention will be described more fully hereinafter in order to facilitate an understanding of the present invention. This invention may be embodied in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and/or" as used herein includes any and all combinations of one or more of the associated listed items.
The experimental procedures, which do not address the specific conditions in the examples below, are generally carried out under conventional conditions or under conditions recommended by the manufacturer. The various chemicals commonly used in the examples are commercially available.
The conventional ossicular prosthesis is a machined integrally formed titanium ossicular prosthesis (the structural schematic diagram is shown in fig. 1), which comprises three parts, namely a top plate 1, a support rod 2 and a base 3. The top plate 1 is in a regular round shape, the round surface is provided with two equal-divided vacancies, and the arrangement of the vacancy structure ensures that the top plate can be better attached to a cartilage pad of an implanted tympanic membrane to prevent the implant from being displaced; the support rod 2 is used for connecting the top plate 1 and the base 3; the base 3 is bowl-shaped or hemispherical, so that the base 3 is more tightly connected with the stapes footplate.
In some embodiments of the present invention, a method for processing a fatigue-resistant ossicular prosthesis is provided, where the ossicular prosthesis may be prepared according to a conventional method, and the ossicular prosthesis may be polished conventionally (to remove burrs and processing lines on the surface of the prosthesis and reduce the surface roughness thereof), to obtain a polished ossicular prosthesis; then the polished ossicular prosthesis is subjected to ultrasonic cavitation water jet impact treatment (the ultrasonic power density of ultrasonic cavitation water jet impact is 0.40W/cm) 2 ～0.50W/cm 2 The water pressure of the ultrasonic cavitation water jet impact is 15-20 MPa), the surface residual compressive stress of the ossicular prosthesis is obviously increased, the surface hardness is obviously improved, the fatigue strength is improved (the increase of the surface residual compressive stress of the metal, the improvement of the surface hardness and the reduction of the surface roughness are all helpful for the improvement of the fatigue strength of the ossicular prosthesis, wherein the size of the surface residual compressive stress and the surface hardness has a slightly larger influence on the size of the fatigue strength), and the stability and the safety of the product are improved; finally, passivating, rinsing, slow-pulling, dehydrating and drying are carried out to finish the processing of the ossicular prosthesis. The processing method of the invention can greatly improve the safety of the ossicular prosthesis, so as to be suitable for performing replacement operation on all or part of ossicular chains of the middle ear when conductive hearing loss of a patient occurs, and rebuilding the sound conductive chain.
In some embodiments, the ultrasonic cavitation water jet impingement ultrasonic power density is 0.45W/cm 2 ～0.55W/cm 2 The water pressure of the ultrasonic cavitation water jet impact is 18MPa to 20MPa, more preferably 20MPa.
In some embodiments, the nozzle is 25mm to 35mm from the surface of the ossicular prosthesis when the ultrasonic cavitation water jet impacts, and the nozzle hole diameter is 0.12mm to 0.15mm.
In some embodiments, the spraying time is 5 min-12 min, preferably 8 min-10 min, less than 5min, and the ultrasonic cavitation water jet impact method is less helpful for improving the surface hardness and fatigue resistance of the ossicular prosthesis, and cavitation may occur due to longer treatment time when the ultrasonic cavitation water jet impact method is higher than 12min, so that the surface roughness is increased, the surface residual compressive stress is reduced, and the like, and the good effect is not achieved.
In some embodiments, the ultrasonic cavitation water jet impingement further comprises the steps of passivating, rinsing, slow-pull dehydrating and drying the ossicular prosthesis after the ultrasonic cavitation water jet impingement.
In some embodiments, the polishing is to put the machined ossicular prosthesis into a mussel Q/YS.406 polishing solution for treatment, so that the ossicular prosthesis can be polished, wherein the polishing time is 30-60S, burrs and processing marks on the ossicular prosthesis are removed after polishing, and the surface roughness of the ossicular prosthesis is reduced.
In some embodiments, the passivation is performed in a 35% -45% nitric acid solution, the passivation temperature is 50+ -2deg.C, and the passivation time is 25 min-35 min.
In some embodiments, the number of rinses is 2-3, each rinse being for 2-3 minutes. Preferably, the number of times of rinsing is 3, and the time is 2min, 2min and 3min in sequence.
In some embodiments, the slow-pull dewatering is performed 2 to 3 times, 3 to 5 minutes per time.
In some of these embodiments, the temperature of the drying (performed in an industrial oven) is 75-85 ℃ and the drying time is 5-8 min.
In some of these embodiments, the ossicular prosthesis is made of a metallic material with good biocompatibility, such as titanium, tantalum, stainless steel, or alloys thereof.
In some of these embodiments, the ossicular prosthesis is a titanium ossicular prosthesis.
In other embodiments of the present invention, fatigue-resistant ossicular prostheses resulting from the above-described processing methods are disclosed.
In the processing method of the fatigue-resistant ossicular prosthesis, the ultrasonic cavitation water jet impact step is carried out in the device shown in fig. 3, wherein an ultrasonic vibration mechanism 1 and a water jet injection mechanism 2 are fixed together, and an injection hole 3 at the lower end of the water jet injection mechanism 1 is completely submerged in deionized water 5 in a cavitation groove 4. When the ultrasonic cavitation water jet is impacted, the ultrasonic vibration mechanism 1 axially vibrates, meanwhile, water is sprayed out from the spray hole 3 at high speed under the action of pressure, and the ultrasonic vibration mechanism and the spray hole cooperate to generate a large number of cavitation bubbles 6 to impact the surface of the ossicle prosthesis 8 fixed on the workbench 7, so that modification is completed.
The reagents and apparatus referred to in the examples below are all commercially available.
The invention is described in detail below with reference to the drawings and the specific embodiments.
Example 1 method of processing fatigue-resistant ossicular prosthesis
The processing method of the fatigue-resistant ossicular prosthesis of the embodiment comprises the following steps (the process route chart please refer to fig. 2):
1. a machined ossicular prosthesis (a sample produced by the applicant and formed by conventional machining processes, the machining process being, in particular, (1) a bone prosthesis having a size ofThe titanium alloy GR5 wire is placed on a double-spindle numerical control core walking machine on the body fluid for fixation, and an end face cutter is used for rough turning of the end face and the outer circle; (2) finish turning all outlines of the auditory ossicle prosthesis except for the hollowed-out top plate; (3) finely milling a hollowed-out outline on the top plate, and removing burrs; (4) stress relief annealing is carried out on the ossicular prosthesis subjected to machining), a certain amount of mussel cis Q/YS.406 polishing solution is put into the ossicular prosthesis to be polished for 45S, and the ossicular prosthesis is taken out after polishing is finished;
2. placing the polished ossicular prosthesis into an ultrasonic cavitation water jet impact treatment device (such asFig. 3) the ossicular prosthesis is fixed to the table by means of a clamp, and the position of the nozzle hole is adjusted so as to be spaced 30mm from the surface of the ossicular prosthesis. Starting a power switch, setting an ultrasonic frequency to 28kHz, and setting the ultrasonic power density to be 0.40W/cm 2 The spray water pressure is 15MPa, and ultrasonic cavitation water jet impact is carried out on the ossicular prosthesis for 8min;
3. placing the ossicle prosthesis subjected to ultrasonic cavitation water jet impact into a nitric acid solution with the concentration of 40%, and passivating at 50 ℃ for 30 min;
4. rinsing the passivated ossicle prosthesis with deionized water at normal temperature for 3 times, wherein the rinsing time is 2min, 2min and 3min in sequence;
5. slowly pulling and dehydrating the rinsed ossicular prosthesis for 2 times for 3 min/time;
and 6, putting the ossicle prosthesis subjected to slow-pull dehydration into an industrial oven, adjusting the temperature of the oven to 80 ℃, and baking for 5min to obtain the fatigue-resistant ossicle prosthesis.
Example 2 method of processing fatigue-resistant ossicular prosthesis
The processing method of the fatigue-resistant ossicular prosthesis of the embodiment except that the ultrasonic power density in the second step is 0.50W/cm 2 Except for this, the procedure was the same as in example 1.
Example 3 method of processing fatigue-resistant ossicular prosthesis
The processing method of the fatigue-resistant ossicular prosthesis of the present embodiment is the same as that of example 1 except that the water pressure emitted from the nozzle in the second step is 20MPa.
Example 4 method of processing fatigue-resistant ossicular prosthesis
The processing method of the fatigue-resistant ossicular prosthesis of the embodiment except that the ultrasonic power density in the second step is 0.50W/cm 2 Except that the water pressure from the nozzle was 20MPa, the same as in example 1 was used.
Comparative example 1A method of processing ossicular prostheses
The processing method of the ossicular prosthesis of this comparative example except that the ultrasonic power density in the second step was 0.30W/cm 2 Water pressure from nozzleThe procedure of example 1 was repeated except that the pressure was 20MPa.
Comparative example 2A method of processing ossicular prostheses
The processing method of the ossicular prosthesis of this comparative example except that the ultrasonic power density in the second step was 0.60W/cm 2 The procedure of example 1 was repeated except that the water pressure from the nozzle was 20MPa.
Comparative example 3A method of processing ossicular prostheses
The processing method of the ossicular prosthesis of this comparative example except that the ultrasonic power density in the second step was 0.50W/cm 2 The procedure of example 1 was repeated except that the water pressure from the nozzle was 10 MPa.
Comparative example 4A method of processing ossicular prostheses
The processing method of the ossicular prosthesis of this comparative example except that the ultrasonic power density in the second step was 0.50W/cm 2 The procedure of example 1 was repeated except that the water pressure from the nozzle was 25 MPa.
Comparative example 5A method of processing ossicular prostheses
The processing method of the ossicular prosthesis of this comparative example except that the ultrasonic power density in the second step was 0.40W/cm 2 The procedure of example 1 was repeated except that the water pressure from the nozzle was 25 MPa.
Comparative example 6 processing method of ossicular prosthesis
The processing method of the ossicular prosthesis of this comparative example except that the ultrasonic power density in the second step was 0.60W/cm 2 The procedure of example 1 was repeated except that the water pressure from the nozzle was 15 MPa.
Comparative example 7A method of manufacturing an ossicular prosthesis
The processing method of the ossicular prosthesis of this comparative example was the same as in example 4, except that the injection time in the second step was 5min.
Comparative example 8A method of manufacturing ossicular prosthesis
The processing method of the ossicular prosthesis of this comparative example was the same as in example 4, except that the injection time in the second step was 15 min.
Comparative example 9A method of manufacturing ossicular prosthesis
The processing method of the ossicular prosthesis of the comparative example was the same as that of example 4 except that the ultrasonic step was performed for 8min in the second step and then the cavitation water jet impact step was performed for 8min.
Comparative example 10A method of processing ossicular prostheses
The processing method of the ossicular prosthesis of this comparative example was the same as in example 4 except that the ejection distance in the second step was 10 mm.
Comparative example 11A method of manufacturing ossicular prosthesis
The processing method of the ossicular prosthesis of this comparative example except that the ultrasonic power density in the second step was 0.50W/cm 2 And the same as in example 1 except for the anhydrous jet injection.
Comparative example 12A method of manufacturing ossicular prosthesis
The processing method of the ossicular prosthesis of the present comparative example was the same as in example 1, except that the water pressure emitted from the nozzle in the second step was 20MPa and no ultrasonic wave was used.
Comparative example 13 processing method of ossicular prosthesis
The ossicular prosthesis of this comparative example was the one machined in example 1 (sample produced by applicant) without any surface treatment.
The relevant parameters of ultrasonic high-pressure compressed water jet impact for fatigue-resistant ossicular prostheses of examples 1-4 and comparative examples 1-13 are shown in Table 1.
The surface residual compressive stress (the negative sign in the table indicates only the direction of the force), the surface microhardness and the surface roughness of the fatigue-resistant ossicle prostheses of examples 1 to 4 and comparative examples 1 to 13 were measured by using a PMT-1000 portable indentation residual stress tester, an euro spectrum OU2560S digital microscopic vickers hardness tester and TR200 surface roughness tester, respectively, and the results are shown in table 1.
The surface morphologies of the ossicular prostheses of example 4, comparative example 4 and comparative example 13 were observed using a PAIRSEN digital microscope, and the surface microscopic morphologies (magnified 800 times) of the three were shown in FIGS. 4 to 6, respectively.
TABLE 1
As is clear from the results in Table 1, the processing of the ossicular prosthesis by ultrasonic cavitation jet treatment technique (combination of ultrasonic cavitation and cavitation water jet) significantly improved both the surface residual compressive stress and the surface hardness of the processed ossicular prosthesis and the surface roughness of less than 0.8 μm (the surface roughness may have other adverse effects such as increased friction with human ear tissue, etc., and therefore, the surface roughness of the processed ossicular prosthesis is preferably not more than 1 μm, at a preferable level (examples 1 to 4). This not only improves the fatigue strength of the ossicular prosthesis, but also ensures a smoother surface. The combined effect achieved is significantly better than that achieved by other parametric treatments (comparative examples 1-6) and ultrasonic cavitation alone (comparative example 11) and water jet cavitation alone (comparative example 12), demonstrating that the ultrasonic power density (0.4W/cm) is relatively low 2 ～0.5W/cm 2 ) And lower injection water pressure (15 MPa-20 MPa), so that better processing effect on the ossicular prosthesis can be realized. The processing method is particularly suitable for parts with high requirements on precision and mechanical properties of ossicular prostheses, and can ensure consistency and uniformity of surface properties after processing. In addition, the two are combined, so that the requirement on the injection pressure can be reduced, the requirement on equipment can be reduced by the lower injection pressure, the cost is saved, and the industrial production is facilitated.
Wherein, the surface residual compressive stress and the surface hardness of the example 4 reach-276 MPa and 462HV respectively, the roughness is 0.77 μm, the effect is optimal, and the surface residual compressive stress and the surface hardness have obvious advantages compared with all the comparative examples. The surface residual compressive stress and the surface hardness effect (251 MPa and 448HV, respectively) of example 1 were slightly worse than those of examples 2 to 4, but still had certain advantages over the comparative example.
In comparison with example 4, comparative examples 1 and 3 were insufficient in strength of the ossicular prosthesis due to too small ultrasonic power density or too small water pressure emitted from the nozzle, resulting in an unsatisfactory increase in surface residual compressive stress and surface hardness.
Compared with example 4, the cavitation impact on the surface of the ossicle is too strong due to the too high ultrasonic power density or the too high water pressure emitted by the nozzle, so that cavitation erosion occurs on the surface of the prosthesis, thereby remarkably increasing the surface roughness of the prosthesis (the surface roughness is larger than 1 μm and is remarkably larger than that of other comparative examples), releasing part of residual compressive stress and reducing the surface hardness. In contrast to example 1, which is slightly less effective, comparative examples 5 and 6 also had cavitation on the surface of the ossicular prosthesis due to too high ultrasonic power density or too high water pressure emitted from the nozzle, resulting in an increase in surface roughness, while both surface residual stress and surface hardness were inferior to those of example 1.
Compared with the example 4, the ultrasonic cavitation jet impact time in the comparative example 7 and the comparative example 8 is 5min and 15min respectively, and the effects of the surface residual compressive stress and the surface hardness are not as good as those of the example 4, which shows that the ideal effects are difficult to achieve when the ultrasonic cavitation jet impact time is too short or too long.
In comparative example 9, the auditory ossicle prosthesis adopts the mode of ultrasonic treatment and then cavitation water jet impact, the effect of the residual compressive stress and the surface hardness of the surface of the auditory ossicle prosthesis is also lower than that of example 4, and the method of carrying out ultrasonic cavitation and cavitation water jet impact separate treatment on the auditory ossicle prosthesis is illustrated, so that the effect is lower than that of carrying out ultrasonic cavitation and cavitation water jet impact simultaneously.
Compared with example 4, the spraying distance in comparative example 10 is only 10mm, the surface residual compressive stress and the surface hardness of the treated ossicular prosthesis are only-141 MPa and 403HV respectively, and the effect is far less than that of example 4, because the spraying distance is too short, the inoculation of cavitation bubbles is insufficient, the generation of cavitation bubbles is less, and a large number of cavitation bubbles are difficult to collapse on the surface of the ossicular prosthesis to generate strong shock waves, so that the expected effect is not achieved.
Further, it can be seen from the surface topography of the ossicular prosthesis of fig. 4 to 6: the auditory ossicle prosthesis (comparative example 13) which was not processed by the present invention had machined striations with more regular directions on the surface; the auditory ossicle prosthesis processed by the invention (example 4) has a smooth surface and no obvious processing lines; the surface of comparative example 4 has obvious pits and surface relief is large, and cavitation erosion occurs on the surface due to the overlarge impact strength of ultrasonic cavitation water jet, so that irregular pits are formed, and the surface roughness is obviously increased.
From the above analysis, it is apparent that the method for processing ossicular prosthesis according to the present invention provides a low ultrasonic power density (0.4W/cm 2 ～0.5W/cm 2 ) And lower cavitation water jet water pressure (15-20 MPa) (when the ultrasonic power density is lower than 0.4W/cm) 2 And/or when the injection water pressure is lower than 15MPa, the ultrasonic cavitation treatment strength is insufficient, and a better effect cannot be achieved; also, when the ultrasonic power density is greater than 0.5W/cm 2 And/or when the spraying water pressure is higher than 20MPa, the ultrasonic cavitation treatment intensity is overlarge, so that cavitation is generated on the surface, the surface roughness is increased, the surface residual compressive stress and the surface hardness are reduced, and the better effect cannot be achieved), the proper spraying time (5 min-12 min) and the proper specified spraying distance (25 mm-35 mm) are ensured, the surface residual compressive stress of the ossicular prosthesis can be obviously increased, the surface hardness of the ossicular prosthesis is improved, and the fatigue strength of the ossicular prosthesis is enhanced, so that the stability and the safety of the ossicular prosthesis are improved. In addition, the lower ultrasonic power density and the lower cavitation water injection pressure reduce the requirements on processing equipment, so that the processing cost is reduced, and the method is more suitable for industrial production.
The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.
The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.
Claims (10)
1. The processing method of the fatigue-resistant ossicular prosthesis is characterized by comprising the following steps of: performing ultrasonic cavitation water jet impact on the polished ossicle prosthesis; the ultrasonic power density of the ultrasonic cavitation water jet impact is 0.40W/cm 2 ～0.50W/cm 2 The water pressure of the ultrasonic cavitation water jet impact is 15 MPa-20 MPa.
2. The method for processing a fatigue-resistant ossicular prosthesis according to claim 1, wherein the ultrasonic cavitation water jet impingement ultrasonic power density is 0.45W/cm 2 ～0.50W/cm 2 The water pressure of the ultrasonic cavitation water jet impact is 18-20 MPa.
3. The method for processing a fatigue-resistant ossicular prosthesis according to claim 1, wherein the distance between the nozzle and the surface of the ossicular prosthesis is 25-35 mm and the diameter of the nozzle hole is 0.12-0.15 mm when the ultrasonic cavitation water jet impacts.
4. The method for processing a fatigue-resistant ossicular prosthesis according to claim 1, wherein the jet time of the ultrasonic cavitation water jet impact is 5-12 min; preferably 8-10 min;
and/or the polishing time is 30 to 60S.
5. The method of processing a fatigue-resistant ossicular prosthesis according to any one of claims 1-4, further comprising the steps of passivating, rinsing, slow-pull dehydrating and drying the ossicular prosthesis after the ultrasonic cavitation water jet impingement treatment.
6. The method for processing a fatigue-resistant ossicular prosthesis according to claim 5, wherein the passivating is performed in a nitric acid solution of 35% -45%, the passivating temperature is 50+ -2 ℃, and the passivating time is 25-35 min.
7. The method for processing a fatigue-resistant ossicular prosthesis of claim 5, wherein the number of rinsing is 2 to 3 and the time of each rinsing is 2 to 3 minutes; preferably, the rinsing is performed for 3 times, and the rinsing time is sequentially 2min, 2min and 3min.
8. The method for processing a fatigue-resistant ossicular prosthesis according to claim 5, wherein the number of slow pull dehydration is 2 to 3 times, 3 to 5 min/time; the temperature of the drying is 75-85 ℃, and the time of the drying is 5-8 min.
9. The method of claim 5, wherein the ossicular prosthesis is made of titanium, tantalum, stainless steel, or alloys thereof; preferably, the ossicular prosthesis is a titanium ossicular prosthesis.
10. A fatigue-resistant ossicular prosthesis obtainable by the process of any one of claims 1 to 9.
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| US20040199261A1 (en) * | 2003-02-24 | 2004-10-07 | Benoist Girard Sas | Surface treatment for a metal prosthesis |
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| DE202009000935U1 (en) * | 2009-01-24 | 2010-07-01 | Heinz Kurz Gmbh Medizintechnik | Passive ossicle prosthesis with applicator |
| JP2019130599A (en) * | 2018-01-29 | 2019-08-08 | 公立大学法人山陽小野田市立山口東京理科大学 | Method for generating ultra-high temperature and high pressure cavitation, method for imparting compressive residual stress onto surface of substance and method for changing geometrical shape, mechanical characteristics and corrosion resistance of the surface, and device for generating ultra-high temperature and high pressure cavitation |
| CN211834872U (en) * | 2020-01-19 | 2020-11-03 | 安徽奥弗智能微创医疗器械有限公司 | Auditory ossicle prosthesis with high reliability |
| CN114949340A (en) * | 2022-06-05 | 2022-08-30 | 南通大学 | Manufacturing method of wear-resistant antibacterial medical titanium alloy surface |
| WO2023193704A1 (en) * | 2022-04-07 | 2023-10-12 | 燕山大学 | Metal having microporous structure on surface, and preparation method therefor and application thereof |
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|---|---|---|---|---|
| US20040199261A1 (en) * | 2003-02-24 | 2004-10-07 | Benoist Girard Sas | Surface treatment for a metal prosthesis |
| US20090165898A1 (en) * | 2007-11-30 | 2009-07-02 | Abbott Laboratories | Fatigue-resistant nickel-titanium alloys and medical devices using same |
| DE202009000935U1 (en) * | 2009-01-24 | 2010-07-01 | Heinz Kurz Gmbh Medizintechnik | Passive ossicle prosthesis with applicator |
| JP2019130599A (en) * | 2018-01-29 | 2019-08-08 | 公立大学法人山陽小野田市立山口東京理科大学 | Method for generating ultra-high temperature and high pressure cavitation, method for imparting compressive residual stress onto surface of substance and method for changing geometrical shape, mechanical characteristics and corrosion resistance of the surface, and device for generating ultra-high temperature and high pressure cavitation |
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| WO2023193704A1 (en) * | 2022-04-07 | 2023-10-12 | 燕山大学 | Metal having microporous structure on surface, and preparation method therefor and application thereof |
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