CN113618234A - Surface roughening method of thin-wall metal shell implanted into human body - Google Patents
Surface roughening method of thin-wall metal shell implanted into human body Download PDFInfo
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
- B23P—METAL-WORKING NOT OTHERWISE PROVIDED FOR; COMBINED OPERATIONS; UNIVERSAL MACHINE TOOLS
- B23P15/00—Making specific metal objects by operations not covered by a single other subclass or a group in this subclass
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
- B23K—SOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM
- B23K26/00—Working by laser beam, e.g. welding, cutting or boring
- B23K26/16—Removal of by-products, e.g. particles or vapours produced during treatment of a workpiece
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
- B23K—SOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM
- B23K26/00—Working by laser beam, e.g. welding, cutting or boring
- B23K26/352—Working by laser beam, e.g. welding, cutting or boring for surface treatment
- B23K26/3568—Modifying rugosity
- B23K26/3584—Increasing rugosity, e.g. roughening
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- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Physics & Mathematics (AREA)
- Optics & Photonics (AREA)
- Plasma & Fusion (AREA)
- Prostheses (AREA)
- ing And Chemical Polishing (AREA)
Abstract
The invention discloses a surface roughening method of a thin-wall metal shell implanted into a human body, belonging to the technical field of medical instruments and comprising the following steps: (1) punching and forming to obtain a metal shell, cleaning the surface of the metal shell, and removing oil stains and impurities on the surface; (2) fixing a metal shell on a processing table, setting a metal surface to be roughened as a processing area, adjusting laser process parameters, focusing the surface to be roughened, starting a laser to scan the metal surface to be roughened, enabling the metal surface to generate a roughening effect, and naturally cooling; (3) scrubbing the metal surface subjected to the laser treatment by using citric acid, and removing oxide particles generated in the laser treatment process; (4) and (4) cleaning the metal surface with water, removing residual citric acid, and naturally drying. The invention can avoid the personal danger of the surface treatment process to the operators, avoid the residue of unexpected foreign matters, not change the structural strength of parts and ensure the biocompatibility and structural reliability of materials.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a surface roughening method of a thin-wall metal shell implanted into a human body.
Background
An implantable cardiac pacemaker is an electronic therapeutic apparatus implanted in a patient for a long time, an electric pulse provided with energy by a battery is delivered by a pulse generator, and the electric pulse is conducted by a lead electrode to stimulate cardiac muscle contacted by the electrode so as to excite and contract the heart, thereby achieving the purpose of treating the cardiac dysfunction caused by certain arrhythmia. As a long-term implant, the pulse generator needs to operate in the human interstitial fluid environment for 8-20 years, for which long-term biocompatibility, long-term structural reliability, and long-term electrical continuity are critical.
The pulse generator of an implantable cardiac pacemaker generally comprises two parts, as shown in fig. 1 and 2, a connector 1 made of non-metallic material and a metal housing 2. The pulse generator shell is generally connected with a power supply and a Hybrid circuit, and is used as a component of an electronic instrument, a sealed shell is needed to prevent body fluid from permeating into the circuit to cause the failure of the instrument, the shell is required to have good biocompatibility and is suitable for being implanted into a human body for a long time, and most of the conventional cardiac pacemakers adopt titanium or titanium alloy as a material of the sealed shell. The housing of the pulse generator is typically made of a thin sheet of titanium or titanium alloy having a thickness of 0.1-0.5 mm.
The metal shell 2 and the non-metal connector 1 are generally connected with each other in a bonding mode, so that the surface of the shell needs to be treated to a certain degree, the roughness of the bonding surface 3 on the metal shell 2 is increased, and the bonding reliability of shell materials and connector materials is enhanced, so that the long-term structural reliability and the long-term electrical connection performance of the shell are ensured.
Meanwhile, the surface treatment process and the process of the shell also need to be strictly controlled, so that the influence of other pollutants in the processing process on the biocompatibility of the part is avoided. If the biocompatibility of the material is not good, infection of the capsular bag for placing the pulse generator, hematoma and the like are easy to occur.
At present, in the technical field of medical instruments, the method for increasing the roughness of the surface of a metal implant mainly comprises the following steps: sand blasting or acid etching, or a combination of both, by which the surface roughness of the metal implant is increased, resulting in a surface with uniform roughness.
For example, U.S. Pat. No. US 6,491,723 discloses a surface treatment method for a metal implant, which comprises performing a first acid etching process using hydrofluoric acid (HF) to remove a native oxide layer on the surface; then, the mixed solution of high temperature sulfuric acid (H2SO 4)/hydrochloric acid (HCl) is used for the second acid etching to form an irregular and uniform surface.
However, hydrofluoric acid is a dangerous chemical and can enter the body through the mouth, nose, eyes or skin, causing severe systemic toxicosis symptoms such as hypocalcemia, hypomagnesemia, pulmonary edema, metabolic acidosis, ventricular arrhythmia, and even death. The sulfuric acid/hydrochloric acid mixed solution is a mixture of two strong acids, and can generate a violent exothermic dehydration reaction during preparation, so that operators can easily burn the mixed solution.
The sand blasting method adopts sand grains mainly comprising alumina, zirconia, steel balls, glass beads and the like. When the fine sand particles impact the metal surface under high pressure to generate pits, part of the sand particles or the fragments thereof are possibly embedded into the material surface, and the fine sand particles and the fragments thereof are difficult to remove from the material surface and easy to remain, thereby influencing the biocompatibility of the shell. In addition to the impact, friction between the grit and the metal surface can also occur, as can the risk of residual grit material. Fig. 3 is a photomicrograph of sand embedded in the metal surface after grit blasting, with zirconia grit in white.
Meanwhile, the rigidity of the thin-wall part with the thickness of 0.1-0.5mm is poor, and the sand blasting of the thin-wall part is easy to cause the part to generate warping deformation, generate residual stress and influence the assembly matching and welding sealing of the shell.
If only a part with a local surface subjected to roughening treatment is needed, the two methods need to adopt an additional means to protect the unmachined surface, so that the whole machining process is complicated, strong acid or high-speed sand grains are easy to invade into an interface to cause the boundary to be fuzzy, and the consistency of a product is not easy to ensure.
Disclosure of Invention
In order to solve the problems in the prior art, the invention provides a surface roughening method for a thin-wall metal shell implanted into a human body, which avoids the personal danger of an operator in the surface treatment process, avoids the residue of unexpected foreign substances, does not change the structural strength of parts, and can ensure the biocompatibility and the structural reliability of materials.
A surface roughening method of a thin-wall metal shell implanted into a human body comprises the following steps:
(1) punching and forming to obtain a metal shell, cleaning the surface of the metal shell, and removing oil stains and impurities on the surface;
(2) fixing a metal shell on a processing table, setting a metal surface to be roughened as a processing area, adjusting laser process parameters, focusing the surface to be roughened, starting a laser to scan the metal surface to be roughened, enabling the metal surface to generate a roughening effect, and naturally cooling;
(3) scrubbing the metal surface subjected to the laser treatment by using citric acid, and removing oxide particles generated in the laser treatment process;
(4) and (4) cleaning the metal surface with water, removing residual citric acid, and naturally drying.
Further, in the step (1), the metal casing is made of pure titanium or titanium alloy, and the thickness of the metal casing is 0.1-0.5 mm.
Further, in the step (1), the step of cleaning the surface of the metal shell specifically comprises: and (3) soaking the metal shell in a cleaning agent, treating the metal shell by ultrasonic waves for 2 to 4 minutes, taking out the metal shell, and naturally drying the metal shell.
Further, the cleaning agent can be 75% medical alcohol, absolute alcohol or absolute isopropanol.
Further, in the step (2), adjusting laser process parameters specifically includes: the power of the laser is adjusted to be 10-100W, the scanning speed is 100-1000mm/s, and the scanning frequency is 50-150 kHz.
The larger the power, the greater the depth of the surface treatment and the higher the roughness value; for a given power, the slower the speed, the greater the energy acting on a unit area, the greater the depth of the surface treatment, the higher the roughness value, but the lower the machining efficiency; for a given power and speed, the frequency decreases, the greater the unit pulse energy, the greater the depth of the surface treatment, and the higher the roughness value of the surface texture. By adjusting the parameters, different surface roughness can be modulated, meanwhile, the base material cannot be subjected to large heat influence, thermal deformation, burning-through and the like cannot occur, and the thickness of the part cannot be changed.
Further, in the step (2), when focusing the surface to be roughened, the spot diameter of the laser beam emitted on the surface to be roughened is less than 0.05 mm.
Further, in the step (3), the concentration of the citric acid is 10-50 g/L.
Further, in the step (4), the metal surface is washed with purified water or deionized water.
The surface roughness before processing is less than Ra0.8um, and the surface roughness after processing is Ra0.8-Ra2.0um.
As a further scheme of the invention: the laser processing method adopted by the invention can control the required processing area through programming, and can carry out accurate local surface treatment without adopting additional protective measures. The method can realize the local processing of a plane and a 3D curved surface.
As a further scheme of the invention: in addition to pure titanium and titanium alloys, the method of the present invention is equally applicable to surgically implanted metallic materials of similar construction, such as stainless steel, MP35N (cobalt chromium nickel molybdenum alloy), and the like.
As a further scheme of the invention, inert gas protection is added in the laser processing process in the step (2), so that oxide splashing is not generated on the surface, and the step (3) can be omitted and the cleaning requirement can be met. The method specifically comprises the following steps:
(1) punching and forming to obtain a metal shell, cleaning the surface of the metal shell, and removing oil stains and impurities on the surface;
(2) fixing the metal shell on a processing table, setting the metal surface to be roughened as a processing area, and adding inert gas protection to the processing area;
adjusting laser process parameters, focusing the surface to be roughened, starting a laser to scan the metal surface to be roughened, enabling the metal surface to generate a roughening effect, and naturally cooling;
(3) and (5) cleaning the metal surface with water, and naturally drying.
Compared with the prior art, the invention has the following beneficial effects:
1. compared with the traditional acid etching method, the method adopts laser as a non-contact processing mode, only needs to provide laser energy, is clean and environment-friendly in process, does not need to use strong corrosive chemical reagents, improves the personal safety of operators, and reduces the supervision and control cost of the processing process.
2. Compared with the traditional sand blasting method, the laser processing method is free from stress, and does not generate mechanical stress residue, so that the thin-wall metal shell is warped and deformed. Meanwhile, no sand grains are embedded or remained on the surface of the shell, so that the biocompatibility and structural reliability of the material are ensured.
3. In the traditional acid etching method and the traditional sand blasting method, parts needing to be locally processed need extra protection measures, and strong acid or sand grains moving at high speed easily invade protected boundaries, so that the interfaces are difficult to control, and the precision and the consistency of products are influenced. The laser processing can accurately control the scanning area of the laser through programming, local processing can be carried out without extra protective measures, the precision is high, and the interface is clear. The process can be effectively simplified, and the treatment links are reduced.
4. The cleaning method before and after laser processing adopts reagents, such as alcohol, isopropanol, citric acid and the like, which are harmless to human bodies, so that the personal danger of operating personnel in the processing process can be effectively avoided.
5. According to the invention, by controlling the laser process parameters, the material at the laser scanning position is not subjected to gasification and evaporation, but is subjected to micro melting and solidification, namely, the material is not removed in the processing process of the invention, the thickness of the part can be kept unchanged, and the structural strength is reliable.
Drawings
FIG. 1 is a schematic diagram of a pulse generator of a prior art implantable cardiac pacemaker;
FIG. 2 is a schematic structural diagram of the metal shell in FIG. 1;
FIG. 3 is a microscopic enlarged view of a metal surface after being processed by sand blasting in the background art;
FIG. 4 is a flow chart of the method of the present invention;
FIG. 5 is a 10-fold microscopic enlarged view of the surface roughening method of example 1 of the present invention;
FIG. 6 is a 45-fold microscopic enlarged view of the surface roughening method of example 1 according to the present invention;
FIG. 7 is a schematic representation of a tensile test conducted after treatment in example 1 of the present invention;
FIG. 8 is a schematic drawing of a tensile section of a tensile test conducted after treatment in example 1 of the present invention.
Detailed Description
The invention will be described in further detail below with reference to the drawings and examples, which are intended to facilitate the understanding of the invention without limiting it in any way.
Example 1:
as shown in fig. 4, a surface roughening method for a thin-walled metal shell implanted in a human body comprises the following steps:
(1) and (4) punching and forming to obtain a metal shell, cleaning the surface of the metal to be treated, and removing oil stains and impurities on the surface.
The metal shell is made of pure titanium TA1, and the cleaning method specifically comprises the following steps: soaking the shell in a cleaning agent, treating the shell with ultrasonic waves for 2 minutes, taking out the shell, and naturally drying the shell; the cleaning agent is anhydrous isopropyl alcohol.
(2) Fixing the metal shell on a processing table, setting a processing area, adjusting laser process parameters, focusing a surface to be processed, starting a laser to scan the metal surface, enabling the surface to generate a roughening effect, and naturally cooling.
Laser process parameters: the power is 10W, the scanning speed is 100mm/s, the scanning frequency is 100kHz, and the diameter of a light spot is about 0.01 mm. The surface roughness of the shell after laser treatment is Ra0.8um.
(3) The treated metal surface is scrubbed with citric acid to remove oxide particles that may be generated during the laser machining process. The citric acid concentration was 10 g/L.
(4) And (5) cleaning the metal surface by using purified water, removing residual citric acid, and naturally airing.
Example 2:
a surface roughening method of a thin-wall metal shell implanted into a human body comprises the following steps:
(1) and (4) punching and forming to obtain a metal shell, cleaning the surface of the metal to be treated, and removing oil stains and impurities on the surface.
The metal shell is made of titanium alloy TC 4; the cleaning method specifically comprises the following steps: soaking the shell in a cleaning agent, treating the shell for 4 minutes by using ultrasonic waves, taking out the shell, and naturally drying the shell; the cleaning agent is absolute alcohol.
(2) Fixing the metal shell on a processing table, setting a processing area, adjusting laser process parameters, focusing a surface to be processed, starting a laser to scan the metal surface, enabling the surface to generate a roughening effect, and naturally cooling.
Laser process parameters: the power is 50W, the scanning speed is 250mm/s, the scanning frequency is 80kHz, and the diameter of a light spot is about 0.01 mm. The surface roughness of the shell after laser treatment is Ra1.2um.
(3) The treated metal surface is scrubbed with citric acid to remove oxide particles that may be generated during the laser machining process. The citric acid concentration was 30 g/L.
(4) And (5) cleaning the metal surface by using purified water, removing residual citric acid, and naturally airing.
Example 3:
a surface roughening method of a thin-wall metal shell implanted into a human body comprises the following steps:
(1) and (4) punching and forming to obtain a metal shell, cleaning the surface of the metal to be treated, and removing oil stains and impurities on the surface.
The metal shell is made of stainless steel 316L; the cleaning method specifically comprises the following steps: soaking the shell in a cleaning agent, treating the shell with ultrasonic waves for 2 minutes, taking out the shell, and naturally drying the shell; the cleaning agent is 75% medical alcohol.
(2) Fixing the metal shell on a processing table, setting a processing area, adjusting laser process parameters, focusing a surface to be processed, starting a laser to scan the metal surface, enabling the surface to generate a roughening effect, and naturally cooling.
Laser process parameters: the power is 100W, the scanning speed is 800mm/s, the scanning frequency is 50kHz, and the diameter of a light spot is about 0.01 mm. The surface roughness of the shell after laser treatment is Ra2.0um.
(3) The treated metal surface is scrubbed with citric acid to remove oxide particles that may be generated during the laser machining process. The citric acid concentration was 50 g/L.
(4) And (4) washing the metal surface by using deionized water, removing residual citric acid, and naturally drying.
To verify the effect of the present invention, the present invention was conducted to test the metal case treated in example 1.
First, the treated shell was observed under a microscope, and fig. 5 is a 10-fold microscopic enlarged view of the surface roughening method of example 1; fig. 6 is a 45-fold microscopic enlarged view of the surface roughening method of example 1, in which an untreated region 4, a boundary 5, and a laser-treated region 6 are arranged in this order from left to right. It can be seen that a uniform and pronounced roughening effect is produced with the method of example 1.
Further, each of the untreated housing and the housing treated in example 1 was prepared as 10 pieces of the joint test article. Tensile test As shown in FIG. 7, the metal shell 2 was fixed, two rods were inserted into the cavity of the connector 1, and upward tensile force was applied, the values of which are shown in Table 1.
TABLE 1 values of snap-apart force of joint
| Number of |
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
| Surface treatment (N) | 229 | 239 | 237 | 210 | 236 | 222 | 249 | 250 | 263 | 260 |
| Surface non-treatment (N) | 104 | 107 | 114 | 113 | 89 | 114 | 86 | 113 | 104 | 96 |
Compared with the tensile strength value, the bonding strength between the surface of the metal shell 2 treated by the embodiment 1 and the connector 1 is remarkably improved.
Further, when the sample after the pulling-off was analyzed, it was found that the case 2, which was not surface-treated, was separated from the connector 1 at the bonding surface 3. On the other hand, in the metal case 2 treated in example 1, the fracture surface structure is shown in fig. 8, and the bonding surface 3 is not separated, and the base material position at the bottom of the connector 1 is fractured, and a fracture surface 7 is generated.
By comprehensively comparing the snapping states and the force values, it can be seen that the bonding strength between the surface of the metal shell treated by the embodiment 1 and the connector is significantly improved, which further illustrates that the invention has a better roughening effect.
Meanwhile, the metal shells treated in the embodiments 2 and 3 are also made into connector experimental products, and similar results to those in the embodiment 1 can be obtained after the test.
In addition, as a supplement to the present invention, the processing method provided by the present invention is suitable for but not limited to metal housings of implantable cardiac pacemakers, Implantable Cardioverter Defibrillators (ICDs), cardiac resynchronization therapy defibrillators (CRT-D), cardiac resynchronization therapy pacemakers (CRT-P), implantable cerebral pacemakers, implantable spinal cord stimulators, implantable sacral nerve stimulators, implantable vagus nerve stimulators, etc.
The embodiments described above are intended to illustrate the technical solutions and advantages of the present invention, and it should be understood that the above-mentioned embodiments are only specific embodiments of the present invention, and are not intended to limit the present invention, and any modifications, additions and equivalents made within the scope of the principles of the present invention should be included in the scope of the present invention.
Claims (10)
1. A surface roughening method of a thin-wall metal shell implanted into a human body is characterized by comprising the following steps:
(1) punching and forming to obtain a metal shell, cleaning the surface of the metal shell, and removing oil stains and impurities on the surface;
(2) fixing a metal shell on a processing table, setting a metal surface to be roughened as a processing area, adjusting laser process parameters, focusing the metal surface to be roughened, starting a laser to scan the metal surface to be roughened, enabling the metal surface to generate a roughening effect, and naturally cooling;
(3) scrubbing the metal surface subjected to the laser treatment by using citric acid, and removing oxide particles generated in the laser treatment process;
(4) and (4) cleaning the metal surface with water, removing residual citric acid, and naturally drying.
2. The method for roughening the surface of a thin-walled metal shell implanted into a human body according to claim 1, wherein in the step (1), the metal shell is made of pure titanium or titanium alloy and has a thickness of 0.1-0.5 mm.
3. The method for roughening the surface of the thin-walled metal shell implanted into the human body according to claim 1, wherein in the step (1), the step of cleaning the surface of the metal shell comprises: and (3) soaking the metal shell in a cleaning agent, treating the metal shell by ultrasonic waves for 2 to 4 minutes, taking out the metal shell, and naturally drying the metal shell.
4. The method for roughening the surface of a thin-walled metal shell implanted into a human body according to claim 3, wherein said cleaning agent is 75% alcohol for medical use, anhydrous alcohol or anhydrous isopropyl alcohol.
5. The method for roughening the surface of the thin-walled metal shell implanted into a human body according to claim 1, wherein in the step (2), the adjusting of the laser process parameters specifically comprises:
the power of the laser is adjusted to be 10-100W, the scanning speed is 100-1000mm/s, and the scanning frequency is 50-150 kHz.
6. The method for roughening the surface of a thin-walled metal shell implanted into a human body according to claim 1, wherein in the step (2), the laser is irradiated on the surface to be roughened, and the spot diameter of the laser is less than 0.05 mm.
7. The method for roughening the surface of a thin-walled metal shell implanted into a human body according to claim 1, wherein the concentration of citric acid in step (3) is 10 to 50 g/L.
8. The method for roughening the surface of a thin-walled metal shell implanted into a human body according to claim 1, wherein in the step (4), the metal surface is washed with purified water or deionized water.
9. A surface roughening method of a thin-wall metal shell implanted into a human body is characterized by comprising the following steps:
(1) punching and forming to obtain a metal shell, cleaning the surface of the metal shell, and removing oil stains and impurities on the surface;
(2) fixing the metal shell on a processing table, setting the metal surface to be roughened as a processing area, and adding inert gas protection to the processing area;
adjusting laser process parameters, focusing the surface to be roughened, starting a laser to scan the metal surface to be roughened, enabling the metal surface to generate a roughening effect, and naturally cooling;
(3) and (5) cleaning the metal surface with water, and naturally drying.
10. The method for roughening the surface of the thin-walled metal shell implanted into the human body according to claim 9, wherein in the step (2), the adjusting of the laser process parameters specifically comprises: adjusting the power of the laser to 10-100W, the scanning speed to 100-;
when focusing the surface to be roughened, the diameter of a light spot of laser light emitted on the surface to be roughened is smaller than 0.05 mm.
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| CN111632195A (en) * | 2020-05-25 | 2020-09-08 | 北京航空航天大学 | Medical implant for improving cell osteogenesis performance and preparation method thereof |
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| US20120312779A1 (en) * | 2005-05-06 | 2012-12-13 | Titian Spine, LLC | Methods for manufacturing implants having integration surfaces |
| CN101905221A (en) * | 2009-06-04 | 2010-12-08 | 中芯国际集成电路制造(上海)有限公司 | Method for cleaning wafer after chemical mechanical polishing |
| CN107717354A (en) * | 2017-11-06 | 2018-02-23 | 金学芳 | A kind of preparation method of body implant titanium alloy rod bar |
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Denomination of invention: A surface roughening method for implanting thin-walled metal shells into the human body Granted publication date: 20230307 Pledgee: Agricultural Bank of China Limited Hangzhou Yuhang Branch Pledgor: Danyuan medical technology (Hangzhou) Co.,Ltd. Registration number: Y2024980016105 |