CN113560735B - Anti-skid surgical suture needle with low reflectivity and anti-adhesion function and processing method - Google Patents

Anti-skid surgical suture needle with low reflectivity and anti-adhesion function and processing method Download PDF

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CN113560735B
CN113560735B CN202110673153.2A CN202110673153A CN113560735B CN 113560735 B CN113560735 B CN 113560735B CN 202110673153 A CN202110673153 A CN 202110673153A CN 113560735 B CN113560735 B CN 113560735B
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suture needle
needle
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CN113560735A (en
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梁春永
王洪水
邹显睿
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Beijing Wanjia High Tech Pharmaceutical Technology Co ltd
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B23MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
    • B23KSOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM
    • B23K26/00Working by laser beam, e.g. welding, cutting or boring
    • B23K26/352Working by laser beam, e.g. welding, cutting or boring for surface treatment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066Needles, e.g. needle tip configurations

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Abstract

The invention relates to an anti-skid surgical suture needle with a low-reflectivity and antibody liquid adhesion functional structure on the surface and a processing method thereof, wherein the surface of the needle tip of the suture needle is provided with the low-reflectivity and antibody liquid adhesion functional structure, the structure is a secondary micro-nano composite structure, the first-stage structure is a groove structure with the width of 5-50 mu m and the depth of 0.2-1 mu m, the second-stage structure is a periodic stripe structure with the width of 250-650nm and the height of 50-200nm, and the second-stage structure is distributed on the surface of the first-stage structure. According to the invention, the composite structure is prepared on the surface of the suture needle by a pulse laser processing method, so that the suture needle is endowed with low reflectivity, antibody liquid adhesion and anti-slip functions, the problem of difficult operation caused by light reflection, liquid adhesion and unstable clamping can be effectively avoided, and the positioning accuracy and operation stability in the operation of the surgical robot can be improved. Meanwhile, the pulse laser processing technology only relates to physical processing, and the introduction of a chemical coating is avoided.

Description

Anti-skid surgical suture needle with low reflectivity and anti-adhesion function and processing method
Technical Field
The invention belongs to the field of medical instruments, and relates to an operation suture needle, in particular to an anti-slip operation suture needle with a structure having a low reflectivity and an antibody liquid adhesion function on the surface and a non-contact physical processing method thereof.
Background
In clinical surgery, the final stage of the surgery requires suturing the wound with suturing. The traditional suture needle materials are mostly metal materials, and the surface is polished, so that the problem that the operation difficulty of doctors is increased due to light reflection easily occurs during operation. Aiming at the problem of reflecting the suture needle, the prior art reduces the reflectivity of the needle body to visible light by preparing a chemical coating blackened suture needle body on the surface, but the direct contact chemical processing method has serious environmental pollution problem, has poor binding force between the coating and a substrate and is easy to fall off in operation.
Meanwhile, various body fluids including blood are easy to adhere to the surface of the suture needle, so that the identification degree of the suture needle can be disturbed, and the postoperative blood pollution is easy to cause. In particular, with the popularization of surgical robots, higher requirements are clinically placed on the accurate positioning and operation stability of suture needles in surgery.
In addition, the suture needle is often designed as a round needle and a triangular needle, and unstable sliding is easy to occur when the suture needle is clamped by the needle holder to suture, so that suture failure is caused.
Therefore, there is a need to develop a surgical suture needle having low reflectivity, antibody liquid adhesion and anti-slip function and a non-contact physical processing method thereof.
Disclosure of Invention
In order to solve the problems of high light reflectivity, no antibody liquid adhesion and no skid resistance of the existing surgical suture needle, the invention provides the skid-resistant surgical suture needle with the surface having the low-reflectivity and antibody liquid adhesion functional structure and the non-contact physical processing method thereof.
The needle surface of the suture needle is provided with a composite structure, and the composite structure has the functions of absorbing light, resisting blood adhesion and stabilizing clamping. The composite structure is composed of two levels of structure superposition. The first level structure is a groove structure with the width of 5-50 mu m and the depth of 0.2-1 mu m, the second level structure is a periodic stripe structure with the width of 250-650nm and the height of 50-200nm, and the second level structure is distributed on the surface of the first level structure. The non-contact physical processing method of the two-stage composite structure is pulse laser processing. The laser processing parameters and the process are as follows: laser wavelength 1060 or 1064nm, pulse energy 20-30 μJ, pulse width about 150fs, pulse frequency 320kHz or 640kHz or 1280kHz, processing speed 500-5000mm/s, and spot size 10-50 μm.
The surface of the needle holding part of the suture needle is provided with an anti-skid structure, the structure is also a two-stage micro-nano structure, wherein the first-stage structure consists of array protrusions with the height of 0.5-5 mu m. The second-level structure is distributed on the surface of the first-level structure and consists of micron or submicron structures such as particles, rods, cones and the like with the diameter of 0.05-1 mu m. The processing method is also pulse laser processing, and the related parameters and the process of the laser processing are as follows: the laser wavelength is 1064nm, the pulse energy is 0.1-2mJ, the pulse width is 270ns, the pulse frequency is 50kHz, the processing speed is 0.1-1000mm/s, and the light spot size is 5-200 mu m.
The two-stage micro-nano structure on the surface of the needle body enables light rays entering the needle body to be refracted, reflected and scattered for multiple times among structures such as micron-level protrusions and submicron-level protrusions, so that the optical path is effectively increased, the absorption of the light on the surface of the material is increased, and the reflectivity of the surface of the needle body to the light is reduced. By regulating and controlling the parameters and the process of laser processing, micro-nano structures with different sizes can be constructed on the surface of the surgical suture needle, so that the surface of the suture needle has different absorbance and reflectance so as to adapt to different clinical requirements. Meanwhile, the two-stage micro-nano structure effectively reduces the surface energy of the suture needle, so that liquid is not easy to adhere to the surface of the needle, the suture needle with the two-stage micro-nano structure has the function of resisting liquid adhesion, the low reflection and easy identification of the suture needle in operation are ensured, and meanwhile, the body fluid pollution is avoided.
The two-stage micro-nano structure of the needle holding part can effectively increase the roughness of the surface of the part, increase the friction between the needle holder and the suture needle, and ensure the clamping stability of the suture needle in operation.
The beneficial effects of the invention are as follows:
the composite structure is prepared on the surface of the suture needle by a pulse laser processing method, so that the suture needle has the functions of low reflectivity, antibody liquid adhesion and skid resistance, the problem of difficult operation caused by light reflection, liquid adhesion and unstable clamping can be effectively avoided, and the positioning accuracy and the operation stability in the operation of the surgical robot can be particularly improved. Meanwhile, the pulse laser processing technology only relates to physical processing, so that the introduction of a chemical coating is avoided, the pulse laser processing technology does not conflict with the existing suture needle production technology, and the difficulty of registration and approval of related implant products can be reduced.
Drawings
FIG. 1 is a schematic view of a needle surface treatment area; the black part is a micro-nano structure surface with low reflectivity and anti-liquid adhesion function, and the oblique line area is a micro-nano structure surface with anti-skid function.
FIG. 2 is a schematic view of the suture needle according to example 1. Wherein a is a suture needle before laser processing, and b is a suture needle after processing.
Fig. 3 is a composite structural diagram formed by pulse laser processing in example 1. Wherein a is a micro-nano structure scanning electron microscope image with low reflectivity and anti-liquid adhesion function, and b is a micro-nano structure scanning electron microscope image with anti-skid function.
Fig. 4 is a composite structural diagram formed by pulse laser processing in example 1. Wherein a is a micro-nano structure scanning electron microscope image with low reflectivity and anti-liquid adhesion function, and b is a micro-nano structure scanning electron microscope image with anti-skid function.
Fig. 5 is a reflectance comparison of the surface of comparative example 1 for the visible light band.
FIG. 6 is a comparison of the amount of surface protein adhering in comparative example 2.
FIG. 7 is a comparison of the amounts of surface platelet adhesion in comparative example 2.
Fig. 8 shows a comparison of the adhesion of blood to a smooth surface and a surface with a composite structure, wherein a portion of the surface of the suture needle was treated with a pulsed laser according to the process of example 1, and the black segment near the needle tip of the suture needle was the laser treated portion, and the bright segment near the tail of the suture needle was the smooth segment that was not pulsed laser processed.
Detailed Description
The invention will be further described by the following examples
Example 1
In this embodiment, a pulsed laser processing method is applied to prepare a micro-nano structure with functions of light absorption, blood adhesion resistance and stable clamping on the surface of a suture needle, and the specific steps are as follows:
the chord length of the sewing needle is 14mm, and the diameter is 1/2 arc sewing (delta 1/26 multiplied by 14) of 0.6 mm.
The laser processing technology is regulated, the wavelength is 1060nm, the pulse width is 150fs, the pulse frequency is 640kHz, and the pulse energy is 24uJ. During processing, the laser is kept to process according to parallel line paths, the processing direction is along the axial direction of the suture needle, the processing speed is 1500mm/s, the line spacing of the processing path is 15um, and the line width is about 20um. The laser beam is always kept perpendicular to the surface of the suture needle during processing, and the distance between the laser focus and the surface of the suture needle is constant. The front end of the whole suture needle body is scanned. The processed structure is a two-stage micro-nano structure, wherein the first-stage structure is a groove structure with the width of about 15 mu m and the depth of 0.2 mu m, the second-stage structure is a periodical stripe structure with the width of 450nm and the height of 90nm, and the second-stage structure is distributed on the surface of the first-stage structure.
Subsequently, the needle holding part is processed by the following processing technology: the laser wavelength is 1064nm, the pulse energy is 1mJ, the pulse width is 270ns, the pulse frequency is 50kHz, the processing speed is 10mm/s, and the light spot size is 100 mu m. The laser beam is always kept perpendicular to the surface of the suture needle during processing, and the distance between the laser focus and the surface of the suture needle is constant. Scanning the whole needle holding part surface. The resulting structure is also a two-stage micro-nano structure, where the first stage structure consists of array protrusions 1 μm high. The second level structure is distributed on the surface of the first level structure and consists of submicron stripe structures with the width of about 1 μm.
Fig. 1 is a schematic view of a surface treatment area of the suture needle, wherein a black area is a micro-nano structure with a low reflectivity and an antibody liquid adhesion function on the surface, and a slant line area is a needle holding part, namely a surface area with an anti-skid function microstructure. Fig. 2 is a physical view of a suture needle, wherein fig. 2a is a suture needle before processing, and fig. 2b is a suture needle after processing. Fig. 3 is a diagram of a micro-nano structure of the surface after processing, wherein fig. 3a is a scanning electron microscope diagram of a micro-nano structure of a front end surface structure of a needle body, namely, a micro-nano structure with low reflectivity and antibody liquid adhesion function, and fig. 3b is a scanning electron microscope diagram of a needle holding part, namely, a micro-nano structure with anti-skid function.
Example 2
In the embodiment, a pulse laser twice processing method is applied to prepare a composite structure with functions of light absorption, blood adhesion resistance and stable clamping on the surface of the suture needle. The suture needle adopts 1/2 arc suture (delta 1/26 multiplied by 10) with the chord length of 10mm and the diameter of 0.6 mm. The method comprises the following specific steps:
the laser processing technology is regulated, the wavelength is 1064nm, the pulse width is 150fs, the pulse frequency is 320kHz, and the pulse energy is 30uJ. During processing, the laser is kept to process according to parallel line paths, the processing direction is along the axial direction of the suture needle, the processing speed is 1500mm/s, the line spacing of the processing path is 45um, and the line width is about 50um. The laser beam is always kept perpendicular to the surface of the suture needle during processing, and the distance between the laser focus and the surface of the suture needle is constant. The front end of the whole suture needle body is scanned. The processed structure is a two-stage micro-nano structure, wherein the first-stage structure is a groove structure with the width of about 45 mu m and the depth of 1.2 mu m, the second-stage structure is a periodic stripe structure with the width of 500nm and the height of 150nm, and the second-stage structure is distributed on the surface of the first-stage structure.
Subsequently, the needle holding part is processed by the following processing technology: the laser wavelength is 1064nm, the pulse energy is 1mJ, the pulse width is 270ns, the pulse frequency is 50kHz, the processing speed is 10mm/s, and the light spot size is 100 mu m. The laser beam is always kept perpendicular to the surface of the suture needle during processing, and the distance between the laser focus and the surface of the suture needle is constant. Scanning the whole needle holding part surface. The resulting structure is also a two-stage micro-nano structure, where the first stage structure consists of array protrusions 1.5 μm high. The second level structure is distributed on the surface of the first level structure and consists of submicron stripe structures with the width of about 0.6 μm.
Fig. 4 is a diagram of a micro-nano structure of the surface after processing, wherein fig. 4a is a scanning electron microscope diagram of a micro-nano structure of a front end surface structure of a needle body, namely, a micro-nano structure with low reflectivity and antibody liquid adhesion function, and fig. 4b is a scanning electron microscope diagram of a needle holding part, namely, a micro-nano structure with anti-skid function.
Comparative example 1
This comparative example compares the reflectivity of a smooth surface to visible light with two surfaces having a composite structure. Wherein the smooth surface was prepared by mechanical polishing, two surface structures having a composite structure were prepared according to the methods and processes of examples 1 and 2, respectively.
The reflectivity of the three surfaces to visible light is measured by an ultraviolet-visible spectrophotometer, and the measurement range is 400-800nm. The three measured visible light reflection spectrums of the surfaces are shown in fig. 5, and compared with the mechanically polished surface, the two surfaces with the composite structures have lower reflectivity to visible light in the wavelength range of 400-800nm, and have obvious light absorption effect.
Comparative example 2
The surface protein adsorption experiments of the suture needle with the composite structure and the smooth suture needle are carried out in the comparative example, and the anti-protein adhesion capability of the two surfaces is compared. Among them, the smooth suture needle of example 2 was selected from the needle type (. DELTA.1/26X 10), and the suture needle with the composite structure was prepared using the same needle type suture needle as in example 2.
Protein adsorption experiments were performed using a microba kit, cu in the kit components 2+ Ions are reduced to Cu when reacting with protein + Ion, cu + The ions react with BCA in the kit components, and the OD value of the solution in which the color reaction occurs is proportional to the protein content. The specific experimental steps are as follows:
(1) Three of the smooth suture needle and the suture needle with the composite structure on the surface are respectively soaked in a solution of 40mg/ml equivalent standard fetal bovine serum, and placed for 30 minutes in a sterile environment at 37 ℃.
(2) The suture needles were taken out separately, washed thoroughly in sterile PBS solution and dried.
(3) The detection reagent is prepared according to the use instructions of the MicroBCA kit, the suture needle is soaked in the detection reagent, and the suture needle is placed for 15 minutes at 37 ℃ to fully carry out the chromogenic reaction.
(4) And respectively taking 100 mu l of each developed solution in a 96-well plate, setting three parallel holes in each group of solutions, measuring the absorbance of the solutions at the wavelength of 562nm, and counting and comparing the adsorption quantity of protein on the surfaces of the smooth suture needle and the suture needle with the composite structure. As shown in fig. 6, the protein adhesion amount on the surface of the suture needle with the composite structure is obviously lower than that of a smooth suture needle, which proves that the pulse laser surface treatment effectively improves the protein adhesion resistance of the suture needle surface and can well avoid the protein adhesion in blood and body fluid in surgical use.
Comparative example 3
This control compares the adhesion of blood to a smooth surface and a surface with a composite structure.
Platelet adhesion experiments were first performed by cutting a thin sheet of stainless steel material of the same material as the suture needle into thin sheets 1mm thick and 4mm by 4mm in size. A smooth stainless steel surface was prepared using a mechanical polishing method, a stainless steel surface with a composite structure was prepared using a femtosecond laser machining process, and the femtosecond laser machining process was identical to that in example 2. The platelet adhesion test method comprises the following steps:
(1) Fresh human whole blood was centrifuged at 1500r/min for 15 min and the supernatant was taken for the experiment.
(2) Three samples of stainless steel having a smooth surface and stainless steel having a composite structure surface were prepared, and 40. Mu.l of the supernatant obtained in the previous step was added dropwise to each sample surface, respectively. The samples were incubated at 37℃for 30 minutes.
(3) Each sample was washed with PBS and the surface of the sample was washed free of blood and non-adherent platelets. The samples were soaked in 2.5% glutaraldehyde solution for 4 hours.
(4) Dehydration samples were sequentially soaked with 30%, 40%, 50%, 60%, 70%, 75%, 80%, 85%, 90%, 95% and 100% absolute ethanol for 15 minutes in each ethanol solution. The samples were then sequentially soaked with solutions of absolute ethanol to hexamethyldisilazane in volume ratios of 3:1, 1:1, 1:3, and 0:1 for 15 minutes with each concentration of liquid.
(5) And (5) drying the samples, then spraying gold, and observing the surfaces of the samples by using SEM. Randomly selecting 15 positions, taking a picture with the magnification of 1000 times, counting and analyzing the number of platelets in the visual field of each position.
As shown in fig. 7, the number of platelets in the 1000-fold magnification view of the smooth stainless steel surface is about 80, and the number of platelets in the 1000-fold magnification view of the stainless steel surface with the composite structure is significantly smaller, which proves that the composite structure prepared by the femtosecond laser processing method is favorable for inhibiting activation and adhesion of platelets.
And an intuitive blood contamination and throwing experiment is performed. As shown in fig. 8, a section near the needle tip (a black section near the needle tip in the drawing) was treated on the surface of one needle by using a pulse laser processing method, and the processing method and process were the same as those in example 1. The section near the needle tail is not treated (the bright section near the needle tail in the figure). 10 mu l of human whole blood is respectively dripped on two surfaces of the suture needle, and the blood drop forms a sphere on the surface with the composite structure, so that the blood drop is not easy to spread. The drop spreads easily on smooth surfaces. Subsequently, the suture needle is gently thrown off, the surface blood drop with the composite structure is completely thrown off, there is no adhesion, and the blood spread on the smooth surface cannot be thrown off. This result demonstrates the resistance of the surface with the composite structure to blood adhesion.

Claims (1)

1. A surgical suture needle, characterized in that: the surface of the needle tip of the suture needle is provided with a low-reflectivity and antibody liquid adhesion functional structure, the structure is a secondary micro-nano composite structure, wherein the primary structure is a groove structure with the width of 45 mu m and the depth of 1.2 mu m, the secondary structure is a periodic stripe structure with the width of 500nm and the height of 150nm, the secondary structure is distributed on the surface of the primary structure, the secondary micro-nano composite structure enables light rays entering the secondary micro-nano composite structure to be refracted, reflected and scattered for multiple times among structures such as micron and submicron protrusions, so that the optical path is effectively increased, the absorption of the material surface to visible light with the wavelength of 400-800nm is increased, and the reflectivity of the needle surface to light is reduced; the laser processing technology comprises the following steps: the wavelength is 1064nm, the pulse width is 150fs, the pulse frequency is 320kHz, the pulse energy is 30uJ, the laser is processed according to parallel line paths during processing, the processing direction is along the axial direction of the suture needle, the processing speed is 1500mm/s, the line spacing of the processing path is 45um, the line width is about 50um, the laser beam is always perpendicular to the surface of the suture needle during processing, the distance between the laser focus and the surface of the suture needle is constant, and the front end of the whole suture needle body is scanned;
the needle holding part of the suture needle is provided with a micro-nano structure with an anti-skid function, the micro-nano mechanism is of a secondary structure, the primary structure is composed of array protrusions with the height of 1.5 mu m, the secondary structure is distributed on the surface of the primary structure, and the secondary structure is composed of submicron stripe structures with the width of 0.6 mu m; the processing technology comprises the following steps: the laser wavelength is 1064nm, the pulse energy is 1mJ, the pulse width is 270ns, the pulse frequency is 50kHz, the processing speed is 10mm/s, the light spot size is 100 mu m, the laser beam is always vertical to the surface of the suture needle during processing, the distance between the laser focus and the surface of the suture needle is constant, and the surface of the whole needle holding part is scanned.
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