CN113769239A - Method for manufacturing medical guide wire - Google Patents
Method for manufacturing medical guide wire Download PDFInfo
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- CN113769239A CN113769239A CN202111187838.2A CN202111187838A CN113769239A CN 113769239 A CN113769239 A CN 113769239A CN 202111187838 A CN202111187838 A CN 202111187838A CN 113769239 A CN113769239 A CN 113769239A
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- core wire
- spring
- stainless steel
- steel core
- nickel
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- 238000004519 manufacturing process Methods 0.000 title claims abstract description 26
- 238000000034 method Methods 0.000 title claims description 25
- 229910001220 stainless steel Inorganic materials 0.000 claims abstract description 107
- 239000010935 stainless steel Substances 0.000 claims abstract description 107
- HZEWFHLRYVTOIW-UHFFFAOYSA-N [Ti].[Ni] Chemical group [Ti].[Ni] HZEWFHLRYVTOIW-UHFFFAOYSA-N 0.000 claims abstract description 36
- 238000005520 cutting process Methods 0.000 claims abstract description 12
- 238000003466 welding Methods 0.000 claims description 35
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims description 18
- 210000001503 joint Anatomy 0.000 claims description 13
- 238000002844 melting Methods 0.000 claims description 10
- 230000008018 melting Effects 0.000 claims description 10
- 238000001816 cooling Methods 0.000 claims description 9
- 238000010438 heat treatment Methods 0.000 claims description 9
- 229910052757 nitrogen Inorganic materials 0.000 claims description 9
- 238000007493 shaping process Methods 0.000 claims description 9
- 238000000576 coating method Methods 0.000 claims description 5
- RVTZCBVAJQQJTK-UHFFFAOYSA-N oxygen(2-);zirconium(4+) Chemical compound [O-2].[O-2].[Zr+4] RVTZCBVAJQQJTK-UHFFFAOYSA-N 0.000 claims description 4
- 238000005507 spraying Methods 0.000 claims description 3
- 239000000463 material Substances 0.000 description 6
- 238000004140 cleaning Methods 0.000 description 4
- 238000003032 molecular docking Methods 0.000 description 4
- 239000012299 nitrogen atmosphere Substances 0.000 description 3
- 239000011248 coating agent Substances 0.000 description 2
- 230000006698 induction Effects 0.000 description 2
- 229910000679 solder Inorganic materials 0.000 description 2
- 238000005476 soldering Methods 0.000 description 2
- 238000004857 zone melting Methods 0.000 description 2
- 210000000013 bile duct Anatomy 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 210000003238 esophagus Anatomy 0.000 description 1
- 230000004907 flux Effects 0.000 description 1
- 229940127554 medical product Drugs 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 231100000915 pathological change Toxicity 0.000 description 1
- 230000036285 pathological change Effects 0.000 description 1
- 238000004381 surface treatment Methods 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
- B21F—WORKING OR PROCESSING OF METAL WIRE
- B21F15/00—Connecting wire to wire or other metallic material or objects; Connecting parts by means of wire
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09108—Methods for making a guide wire
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2207/00—Methods of manufacture, assembly or production
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biomedical Technology (AREA)
- Pulmonology (AREA)
- Anesthesiology (AREA)
- Biophysics (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Mechanical Engineering (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
The invention discloses a manufacturing method of a medical guide wire, wherein the manufacturing method of the medical guide wire comprises the following steps: cutting at least one end of the nickel-titanium core wire; connecting the cut end of the nickel-titanium core wire with a stainless steel core wire to form a first whole; sleeving the first whole into a pre-wound spring; the stainless steel core wire and the spring are directly welded, and the whole body is cleaned.
Description
Technical Field
The invention relates to the technical field of medical guide wires, in particular to a medical guide wire and a manufacturing method thereof.
Background
With continuous exploration and pursuit of minimally invasive treatment, more and more self-expandable stents and release systems are applied to treatment of pathological changes in various human body lumens, such as bile ducts, esophagus, neurovascular and the like. Currently, in surgery, the delivery of self-expanding stents is typically accomplished using a delivery guidewire. The medical guide wire is a medical product, has the functions of guiding, positioning or puncturing and the like, and is a special metal wire widely applied in operations.
In the prior art, a main body of the medical guide wire is made of stainless steel, and a Sn ball is used as a solder, so that the stainless steel guide wire has poor wettability after the solder is melted by heat in a welding process, and the situations of insufficient soldering, false soldering and the like are easy to occur, so that the product yield is influenced.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provides a medical guide wire and a manufacturing method thereof, wherein at least one end of a nickel-titanium core wire is cut; connecting the cut end of the nickel-titanium core wire with a stainless steel core wire to form a first whole; sleeving the first whole into a pre-wound spring; the stainless steel core wire and the spring are directly welded and are integrally cleaned, welding auxiliary materials are not adopted, so that insufficient welding and false welding caused by welding auxiliary materials are avoided, the yield of the medical guide wire is improved, the repeatability and stability of manufacturing the medical guide wire are improved, and the quality of manufacturing the medical guide wire is ensured.
In order to solve the technical problem, an embodiment of the present invention provides a method for manufacturing a medical guidewire, including: cutting at least one end of the nickel-titanium core wire; connecting the cut end of the nickel-titanium core wire with a stainless steel core wire to form a first whole; sleeving the first whole into a pre-wound spring; the stainless steel core wire and the spring are directly welded, and the whole body is cleaned.
Optionally, at least one end of the cut nitinol wire comprises: horizontally placing the nickel-titanium core wire, and cutting at least one end of the nickel-titanium core wire; flattening the cut end of the nickel-titanium core wire; the flattened nickel-titanium core wire is butted with the stainless steel core wire.
Optionally, the step of sleeving the first whole into the pre-wound spring includes: the spring is correspondingly wound based on a preset diameter; and sleeving the first whole body, which is connected with the cutting end of the nickel-titanium core wire and the stainless steel core wire, into the pre-wound spring.
Optionally, the stainless steel core wire and the spring are directly welded, and the integral cleaning is performed, including: horizontally clamping the stainless steel core wire and the spring by adopting two clamps respectively; horizontally butting the stainless steel core wire with the spring; carrying out laser welding on a butt joint between the stainless steel core wire and the spring, and heating to a molten state; and filling nitrogen into the welding part between the stainless steel core wire and the spring, and cooling and shaping.
Optionally, the outer diameter of the welding position between the stainless steel core wire and the spring is 0.015-0.017 inch, and the tensile strength is larger than or equal to 500 MPa.
Optionally, the stainless steel core wire and the spring are directly welded, and the integral cleaning is performed, including: horizontally clamping the stainless steel core wire and the spring by adopting two clamps respectively; horizontally butting the stainless steel core wire with the spring; carrying out high-frequency eddy melting on a butt joint between the stainless steel core wire and the spring, and heating to a molten state; and filling nitrogen into the welding part between the stainless steel core wire and the spring, and cooling and shaping.
Optionally, the outer diameter of the welding position between the stainless steel core wire and the spring is 0.013-0.016 inches, and the tensile strength is larger than or equal to 400 MPa.
Optionally, the stainless steel core wire and the spring are directly welded, and the integral cleaning is performed, including: horizontally clamping the stainless steel core wire and the spring by adopting two clamps respectively; horizontally aligning the stainless steel core wire with the spring; controlling the distance between the stainless steel core wire and the spring to be 1-10 mu m; electrifying the two clamps, and pressurizing the two clamps to 10kV respectively to enable the butt joint between the stainless steel core wire and the spring to be in a molten state; and filling nitrogen into the joint between the stainless steel core wire and the spring, and cooling and shaping.
Optionally, the outer diameter of the welding position between the stainless steel core wire and the spring is 0.014-0.016 inches, and the tensile strength is more than or equal to 500 MPa.
Optionally, the method further includes: and spraying hydrophilic coatings on the nickel-titanium core wire, the stainless steel core wire and the spring.
In an embodiment of the invention, at least one end of the nitinol wire is cut by the method of an embodiment of the invention; connecting the cut end of the nickel-titanium core wire with a stainless steel core wire to form a first whole; sleeving the first whole into a pre-wound spring; the stainless steel core wire and the spring are directly welded and are integrally cleaned, welding auxiliary materials are not adopted, so that insufficient welding and false welding caused by welding auxiliary materials are avoided, the yield of the medical guide wire is improved, the repeatability and stability of manufacturing the medical guide wire are improved, and the quality of manufacturing the medical guide wire is ensured.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.
Fig. 1 is a schematic flow chart of a method of manufacturing a medical guidewire in an embodiment of the invention;
fig. 2 is a schematic view of the docking of the medical guide wire according to the present invention;
fig. 3 is a schematic diagram of a docking of a medical guidewire according to an embodiment of the present invention;
fig. 4 is a schematic view of the docking of the medical guide wire according to the second embodiment of the present invention;
fig. 5 is a schematic view of the docking of the medical guide wire according to an embodiment of the present invention.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Examples
As shown in fig. 1 and 2, a method for manufacturing a medical guidewire includes:
s11: cutting at least one end of the nickel-titanium core wire;
in the specific implementation process of the invention, the specific steps can be as follows: horizontally placing the nickel-titanium core wire, and cutting at least one end of the nickel-titanium core wire; flattening the cut end of the nickel-titanium core wire; the flattened nickel-titanium core wire is butted with the stainless steel core wire.
The cutting end of the nickel-titanium core wire is flattened, so that the nickel-titanium core wire is in butt joint with the stainless steel core wire, and the connectivity of the nickel-titanium core wire and the stainless steel core wire is improved.
S12: and connecting the cut end of the nickel-titanium core wire with the stainless steel core wire to form a first whole.
The cutting end of the nickel-titanium core wire and the stainless steel core wire are connected horizontally and form a first whole body, so that the connection of the spring is realized based on the first whole body.
S13: and sleeving the first whole body into the pre-wound spring.
In the specific implementation process of the invention, the specific steps can be as follows: the spring is correspondingly wound based on a preset diameter; and sleeving the first whole body, which is connected with the cutting end of the nickel-titanium core wire and the stainless steel core wire, into the pre-wound spring.
The springs are correspondingly wound based on preset diameters, and various springs with different diameters are formed, so that the springs with different diameters can be connected conveniently.
S14: the stainless steel core wire and the spring are directly welded, and the whole body is cleaned.
The stainless steel core wire and the spring are clamped and fixed through a clamp, the stainless steel core wire and the spring are fixed through the clamp, the stainless steel core wire and the spring are butted, a certain local heating method is adopted, such as high-energy laser melting, high-frequency induction zone melting, high-voltage discharge melting and the like, so that the interface between the stainless steel core wire and the spring is locally melted, heating is stopped after a certain time, and the interface between the stainless steel core wire and the spring is automatically welded. The welding process can realize accurate regulation and control by adjusting the technical parameters of heating, has high production repeatability and stable performance, and can greatly improve the yield of the key process.
The first embodiment is as follows:
in the specific implementation process of the invention, the specific steps can be as follows: horizontally clamping the stainless steel core wire and the spring by adopting two clamps respectively; horizontally butting the stainless steel core wire with the spring; carrying out laser welding on a butt joint between the stainless steel core wire and the spring, and heating to a molten state; and filling nitrogen into the welding part between the stainless steel core wire and the spring, and cooling and shaping. The outer diameter of the welding position between the stainless steel core wire and the spring is 0.015-0.017 inch, and the tensile strength is larger than or equal to 500 MPa.
Referring to fig. 3, a stainless steel core wire with an outer diameter of 0.014 inches was fixed using a jig, a spring with an outer diameter of 0.018 was fixed using a jig, the stainless steel core wire was butted against the spring, the butted portion of the stainless steel core wire and the spring was irradiated with a high-energy laser with a power of 10kW, so that the butted portion of the stainless steel core wire and the spring was in a molten state, the irradiation was stopped after 100ms, and the temperature was rapidly reduced and cooled in a nitrogen atmosphere, and then the butted portion of the stainless steel core wire and the spring was automatically welded. The outer diameter of the joint of the stainless steel core wire and the spring is 0.015-0.017 inch, and the tensile strength is more than or equal to 500 MPa.
The second embodiment is as follows:
in the specific implementation process of the invention, the specific steps can be as follows: horizontally clamping the stainless steel core wire and the spring by adopting two clamps respectively; horizontally butting the stainless steel core wire with the spring; carrying out high-frequency eddy melting on a butt joint between the stainless steel core wire and the spring, and heating to a molten state; and filling nitrogen into the welding part between the stainless steel core wire and the spring, and cooling and shaping. The outer diameter of the welding part between the stainless steel core wire and the spring is 0.013-0.016 inches, and the tensile strength is larger than or equal to 400 MPa.
Referring to fig. 4, the stainless steel core wire with an outer diameter of 0.012 inches is fixed by a clamp, the spring with an outer diameter of 0.016 is fixed by a clamp, the stainless steel core wire and the spring are butted, the butted part of the stainless steel core wire and the spring is heated by a high-frequency eddy current melting device with a power of 1kW, so that the guide wire at the butted part of the stainless steel core wire and the spring is in a molten state, power supply is stopped after 1s, the temperature is rapidly reduced and the guide wire is cooled in a nitrogen atmosphere, and then the interfaces of the two guide wires are automatically welded. The outer diameter of the joint of the stainless steel core wire and the spring is 0.013-0.016 inches, and the tensile strength is larger than or equal to 400 MPa.
The third concrete embodiment:
in the specific implementation process of the invention, the specific steps can be as follows: horizontally clamping the stainless steel core wire and the spring by adopting two clamps respectively; horizontally aligning the stainless steel core wire with the spring; controlling the distance between the stainless steel core wire and the spring to be 1-10 mu m; electrifying the two clamps, and pressurizing the two clamps to 10kV respectively to enable the butt joint between the stainless steel core wire and the spring to be in a molten state; and filling nitrogen into the joint between the stainless steel core wire and the spring, and cooling and shaping. The outer diameter of the welding position between the stainless steel core wire and the spring is 0.014-0.016 inches, and the tensile strength is more than or equal to 500 MPa.
Referring to fig. 5, the stainless steel core wire with an outer diameter of 0.014 inches was fixed using a jig, the spring with an outer diameter of 0.016 was fixed using a jig 33, the stainless steel core wire and the spring were aligned, the distance between the stainless steel core wire and the spring was controlled to be 1 to 10 μm, a voltage of 10kV was applied between the two jigs, a current was 50mA, the power was turned off after 100ms, the butt joint of the stainless steel core wire and the spring was in a molten state, the butt joint of the stainless steel core wire and the spring was rapidly cooled down in a nitrogen atmosphere, and then the butt joint of the stainless steel core wire and the spring was automatically welded. The outer diameter of the joint of the stainless steel core wire and the spring is 0.014-0.016 inches, and the tensile strength is more than or equal to 500 MPa.
In addition, the embodiment lists three methods of high-energy laser melting, high-frequency induction zone melting and high-voltage discharge melting for local hot melting of the welding port to realize the welding of the medical guide wire. Other situations which conform to the automatic welding mode of no welding flux and local high-temperature hot melting of the welding port to prepare the medical guide wire are all within the protection scope of the invention.
S15: and spraying hydrophilic coatings on the nickel-titanium core wire, the stainless steel core wire and the spring.
And cleaning and drying the nickel-titanium core wire, the stainless steel core wire and the spring, performing surface treatment on the nickel-titanium core wire, the stainless steel core wire and the spring, coating a hydrophilic coating, and then performing further subsequent processes to finally manufacture a finished product.
In an embodiment of the invention, at least one end of the nitinol wire is cut by the method of an embodiment of the invention; connecting the cut end of the nickel-titanium core wire with a stainless steel core wire to form a first whole; sleeving the first whole into a pre-wound spring; the stainless steel core wire and the spring are directly welded and are integrally cleaned, welding auxiliary materials are not adopted, so that insufficient welding and false welding caused by welding auxiliary materials are avoided, the yield of the medical guide wire is improved, the repeatability and stability of manufacturing the medical guide wire are improved, and the quality of manufacturing the medical guide wire is ensured.
The principle and embodiments of the present invention should be explained by using specific examples, and the above descriptions of the examples are only used to help understanding the method and the core idea of the present invention; meanwhile, for a person skilled in the art, according to the idea of the present invention, there may be variations in the specific embodiments and the application scope, and in summary, the content of the present specification should not be construed as a limitation to the present invention.
Claims (10)
1. A method of manufacturing a medical guidewire, comprising:
cutting at least one end of the nickel-titanium core wire;
connecting the cut end of the nickel-titanium core wire with a stainless steel core wire to form a first whole;
sleeving the first whole into a pre-wound spring;
the stainless steel core wire and the spring are directly welded, and the whole body is cleaned.
2. The method for manufacturing a medical guide wire according to claim 1, wherein at least one end of the cut nitinol wire comprises:
horizontally placing the nickel-titanium core wire, and cutting at least one end of the nickel-titanium core wire;
flattening the cut end of the nickel-titanium core wire;
the flattened nickel-titanium core wire is butted with the stainless steel core wire.
3. The method of claim 1, wherein said nesting the first monolith into a pre-wound spring comprises:
the spring is correspondingly wound based on a preset diameter;
and sleeving the first whole body, which is connected with the cutting end of the nickel-titanium core wire and the stainless steel core wire, into the pre-wound spring.
4. The method of manufacturing a medical guidewire according to claim 1, wherein the stainless steel core wire is directly welded to the spring and is integrally cleaned, comprising:
horizontally clamping the stainless steel core wire and the spring by adopting two clamps respectively;
horizontally butting the stainless steel core wire with the spring;
carrying out laser welding on a butt joint between the stainless steel core wire and the spring, and heating to a molten state;
and filling nitrogen into the welding part between the stainless steel core wire and the spring, and cooling and shaping.
5. The method for manufacturing the medical guide wire according to claim 4, wherein the outer diameter of the welding part between the stainless steel core wire and the spring is 0.015-0.017 inches, and the tensile strength is more than or equal to 500 MPa.
6. The method of manufacturing a medical guidewire according to claim 1, wherein the stainless steel core wire is directly welded to the spring and is integrally cleaned, comprising:
horizontally clamping the stainless steel core wire and the spring by adopting two clamps respectively;
horizontally butting the stainless steel core wire with the spring;
carrying out high-frequency eddy melting on a butt joint between the stainless steel core wire and the spring, and heating to a molten state;
and filling nitrogen into the welding part between the stainless steel core wire and the spring, and cooling and shaping.
7. The method for manufacturing a medical guide wire according to claim 6, wherein the outer diameter of the welded portion between the stainless steel core wire and the spring is 0.013 to 0.016 inches, and the tensile strength is not less than 400 MPa.
8. The method of manufacturing a medical guidewire according to claim 1, wherein the stainless steel core wire is directly welded to the spring and is integrally cleaned, comprising:
horizontally clamping the stainless steel core wire and the spring by adopting two clamps respectively;
horizontally aligning the stainless steel core wire with the spring;
controlling the distance between the stainless steel core wire and the spring to be 1-10 mu m;
electrifying the two clamps, and pressurizing the two clamps to 10kV respectively to enable the butt joint between the stainless steel core wire and the spring to be in a molten state;
and filling nitrogen into the joint between the stainless steel core wire and the spring, and cooling and shaping.
9. The method for manufacturing a medical guide wire according to claim 8, wherein the outer diameter of the welded portion between the stainless steel core wire and the spring is 0.014 to 0.016 inches, and the tensile strength is not less than 500 MPa.
10. The method for manufacturing a medical guidewire according to any one of claims 1-9, further comprising:
and spraying hydrophilic coatings on the nickel-titanium core wire, the stainless steel core wire and the spring.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111187838.2A CN113769239A (en) | 2021-10-12 | 2021-10-12 | Method for manufacturing medical guide wire |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111187838.2A CN113769239A (en) | 2021-10-12 | 2021-10-12 | Method for manufacturing medical guide wire |
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| Publication Number | Publication Date |
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| CN113769239A true CN113769239A (en) | 2021-12-10 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN202111187838.2A Pending CN113769239A (en) | 2021-10-12 | 2021-10-12 | Method for manufacturing medical guide wire |
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Address after: 414000 floors 1, 3 and 4, building 7, phase II, innovation and entrepreneurship Park, Tianyue new area, Pingjiang County, Yueyang City, Hunan Province Applicant after: Hunan Xinke Medical Technology Co.,Ltd. Address before: 414000 floors 1, 3 and 4, building 7, phase II, innovation and entrepreneurship Park, Tianyue new area, Pingjiang County, Yueyang City, Hunan Province Applicant before: Hunan Shunmei Medical Technology Co.,Ltd. |
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Application publication date: 20211210 |