A drug-loaded anastomosis nail processing technology

By creating drug-loaded grooves on the staples and spraying medication, the inflammation problem caused by early bacterial adhesion to the staples was solved, achieving long-term effective protection and accelerated wound healing during use.

CN116475698BActive Publication Date: 2026-02-24JIANGSU BRIGHTNESS MEDICAL DEVICES CO LTD
View PDF 2 Cites 0 Cited by

Patent Information

Application Number
CN202310468009.4
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2023-04-26
Publication Date
2026-02-24
Estimated Expiration
2043-04-26

AI Technical Summary

Technical Problem

The existing drug-loaded groove structure design of anastomotic staples in the current manufacturing process, the existing drug-loaded groove design of anastomotic staples, the technical problems existing in the design of anastomotic staples in the field of anastomotic staples, the technical problems existing in the drug-loaded groove design of anastomotic staples, the application of the drug-loaded groove of anastomotic staples, the design of the drug-loaded groove of anastomotic staples, the problems of bacterial adhesion and inflammation affecting wound healing.

Method used

By creating drug-loaded grooves on the staples and spraying the medication into them, the medication is continuously released through the staple feet during use, thus accelerating wound healing.

Benefits of technology

This technology enables the continuous release of medication through the nail feet of the drug-eluting staple during use, improving the speed and effectiveness of wound healing, providing long-term effective protection, and reducing postoperative complications.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure CN116475698B_ABST
    Figure CN116475698B_ABST
Patent Text Reader

Abstract

The present application relates to the technical field of medical devices, in particular to a drug-loaded anastomosis nail processing technology, which comprises the following steps: slotting or drilling is performed on a metal wire by a laser cutting device, and the end of the metal wire is cut into a pointed end structure as a drug-loaded anastomosis nail base; the obtained drug-loaded anastomosis nail base is cleaned; the cleaned drug-loaded anastomosis nail base is fitted and installed on a spraying assembly, and a spraying solution containing an antibacterial drug and a polymer carrier is used to spray the drug-loaded anastomosis nail base under the condition that the spraying assembly drives the drug-loaded anastomosis nail base to rotate; the obtained sprayed drug-loaded anastomosis nail base is formed into a U-shaped nail on a nail forming tool, and the U-shaped nail is the drug-loaded anastomosis nail. The present application is provided with a drug-loading groove on the anastomosis nail, and the drug is sprayed into the drug-loading groove. When the anastomosis nail is used, the drug is continuously released through the nail foot of the drug-loaded anastomosis nail, and the wound healing is accelerated.
Need to check novelty before this filing date? Find Prior Art

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a process for manufacturing drug-eluting anastomotic staples. Background Technology

[0002] Traditional suturing of skin and tissue wounds involves manual stitching with needles and sutures, requiring a high level of surgical skill and necessitating manual removal of the sutures after healing. In recent years, disposable alloy staplers have become increasingly widely used in surgeries both domestically and internationally. Using staplers simplifies the procedure, significantly shortens surgical time, is safe and reliable, ensures a high success rate, and effectively reduces postoperative complications. With the rapid development of medical technology, staplers with only suturing functions are no longer sufficient to meet practical needs.

[0003] Existing staples and their processing technology still have certain shortcomings. In the early stages after anastomosis of internal wounds, staples cannot prevent bacterial adhesion, which may lead to inflammation. They cannot provide long-term effective protection during the wound healing period, affecting the speed and effect of wound healing. Summary of the Invention

[0004] Based on the aforementioned problems in the existing technology, the purpose of this invention is to provide a manufacturing process for drug-loaded anastomotic staples, wherein a drug-loaded groove is formed on the anastomotic staple, and the drug is sprayed into the drug-loaded groove. When the anastomotic staple is used, the drug is continuously released through the staple feet to accelerate wound healing.

[0005] The technical solution adopted by this invention to solve its technical problem is as follows: This invention discloses a process for processing drug-loaded anastomotic staples, including the following steps:

[0006] S1: Grooves or holes are made in the metal wire using a laser cutting device, and the end of the metal wire is cut into a pointed structure to serve as the substrate for drug-loaded anastomosis staples;

[0007] S2: Clean the drug-loaded anastomosis staple substrate obtained in step S1;

[0008] S3: The drug-loaded anastomosis staple substrate cleaned in step S2 is fitted onto the spraying assembly, and while the spraying assembly drives the drug-loaded anastomosis staple substrate to rotate, the drug-loaded anastomosis staple substrate is sprayed with a spraying solution containing antibacterial drugs and polymer carriers.

[0009] S4: The drug-loaded anastomosis staple substrate obtained in step S3 is coated and then formed into a U-shaped staple on a staple forming fixture, which is the drug-loaded anastomosis staple.

[0010] Furthermore, in S1, the metal wire is slotted or perforated by laser cutting at a height of 0.2-0.8 mm.

[0011] Furthermore, in S1, the angle between the cut surface of the tip structure and the cylindrical surface of the metal wire is between 10 and 50°.

[0012] Furthermore, in S2, the drug-loaded anastomotic staple matrix is ​​placed in a dispersion containing phosphoric acid and sulfuric acid at a temperature of 50°C and ultrasonically removed for 5-30 seconds, then placed in anhydrous ethanol and ultrasonically cleaned 3 times for 1 minute each time, and then the surface is dried with compressed air.

[0013] Furthermore, in S3, the spraying method is ultrasonic spraying, the ultrasonic power is 1-2W, the spraying solution flow rate is 0.01-0.1mL / min, the fixture rotation speed is 200-1000r / min, and the number of spraying revolutions is 5-10 revolutions.

[0014] Furthermore, in S3, the solvent in the spraying solution is one or a combination of two or more of tetrahydrofuran, dichloromethane, acetone, methanol, and concentrated ammonia, the antibacterial drug content is 10-100 mg / mL, and the polymer carrier content is 10-20 mg / mL.

[0015] Furthermore, in S4, the grooves or holes on the sprayed drug-loaded anastomotic staple substrate are fitted onto the staple forming fixture in the bending direction, a pressure of 40N is applied, and the pressure is removed after 3-5 seconds to complete the staple making.

[0016] The beneficial effects of this invention are as follows: The processing technology of the drug-loaded anastomosis staple of this invention includes slotting or drilling a hole in a metal wire using a laser cutting device, and cutting the end of the metal wire into a pointed structure as the drug-loaded anastomosis staple substrate; cleaning the obtained drug-loaded anastomosis staple substrate; fitting the cleaned drug-loaded anastomosis staple substrate onto a spraying assembly, and spraying the drug-loaded anastomosis staple substrate with a spraying solution containing antibacterial drugs and polymer carriers while the spraying assembly drives the drug-loaded anastomosis staple substrate to rotate; the obtained sprayed drug-loaded anastomosis staple substrate is then formed into a U-shaped staple on a staple forming fixture, which is the drug-loaded anastomosis staple. This invention provides a drug-loaded groove on the anastomosis staple and sprays the drug into the drug-loaded groove. During use, the drug is continuously released through the staple feet of the drug-loaded anastomosis staple, accelerating wound healing. Attached Figure Description

[0017] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0018] Figure 1 This is a schematic diagram of the apparatus for manufacturing drug-loaded anastomotic staples according to the first embodiment of the present invention;

[0019] Figure 2 This is a cross-sectional view of the cutting and grooving fixture according to the first embodiment of the present invention;

[0020] Figure 3 This is a schematic diagram of the mounting base according to the first embodiment of the present invention;

[0021] Figure 4 This is a schematic diagram of the installation fixture according to the first embodiment of the present invention;

[0022] Figure 5 This is a schematic diagram of the structure of the protective tube according to the first embodiment of the present invention;

[0023] Figure 6 This is an exploded view of the nail-making assembly according to the first embodiment of the present invention;

[0024] Figure 7 This is a schematic diagram of the base according to the first embodiment of the present invention;

[0025] Figure 8 This is a schematic diagram of the nail plate according to the first embodiment of the present invention;

[0026] Figure 9 This is a bottom view of the nail tray according to the first embodiment of the present invention;

[0027] Figure 10 This is a schematic diagram of the structure of the nail presser according to the first embodiment of the present invention;

[0028] Figure 11 This is a process flow diagram of the drug-loaded anastomosis staple manufacturing process according to the second embodiment of the present invention.

[0029] The component names and their numbers in the diagram are as follows:

[0030] Apparatus 100 for making drug-loaded anastomotic staples;

[0031] Cutting and grooving fixture 1, fixture body 11, fixing hole 12, cutting part 13, air diversion port 14;

[0032] Spraying component 2, mounting base 21, base 211, threaded hole 2111, mounting rod 212, mounting clamp 22, mounting part 221, limiting part 222, limiting groove 2221, mating hole 223, mounting hole 224, flow groove 225, protective tube 23, spray nozzle 231, limiting piece 232;

[0033] Nail-making assembly 3, base 31, placement part 311, positioning groove 3111, pressing groove 312, mating groove 313, nail tray 32, nail pressing port 321, placement groove 322, positioning part 323, nail presser 33, top plate 331, mating part 332, pressing block 333. Detailed Implementation

[0034] The present invention will now be described in detail with reference to the accompanying drawings. These drawings are simplified schematic diagrams, illustrating only the basic structure of the invention, and therefore only show the components relevant to the invention.

[0035] like Figure 1 As shown, the first embodiment of the present invention provides an apparatus 100 for manufacturing drug-loaded anastomotic staples, including a cutting and grooving fixture 1, a spraying assembly 2, and a staple-making assembly 3. The cutting and grooving fixture 1 is used for the drug-loaded groove 41 and tip 42 of the drug-loaded anastomotic staple 4, the spraying assembly 2 is used for spraying drug into the drug-loaded groove 41 of the drug-loaded anastomotic staple 4, and the staple-making assembly 3 is used for manufacturing the drug-loaded anastomotic staple 4 into a U-shaped staple.

[0036] Specifically, such as Figure 2 As shown, the cutting and grooving fixture 1 includes a fixture body 11, a fixing hole 12 extending through the fixture body 11, a cutting section 13 disposed on the fixture body 11, and an air diversion port 14 disposed on one side of the cutting section 13. The lower end of the fixture body 11 is cylindrical, and the fixture body 11 is fixed to the chuck of a laser cutting machine (not shown in the figure). The fixing hole 12 is a circular through hole, extending through the upper and lower ends of the fixture body 11, and is located at the center of the lower and upper ends of the fixture body 11. The fixing hole 12 is used to place a straight metal wire. The cutting section 13 is disposed on the side of the fixture body 11, and the bottom surface of the cutting section 13 is located at half of the side of the fixing hole 12. The cutting section 13 is used to cut the metal wire placed in the fixing hole 12 and located on one side of the cutting section 13 into a drug-loaded groove by the laser cutting machine. The air diversion port 14 is a through-hole in the shape of an oblong shape. Multiple air diversion ports 14 are provided and are evenly arranged with the through-hole 12 as the reference line. When it is necessary to cut out the loading tank, the position of the fixture body 11 on the laser cutting machine is adjusted so that the air diversion port 14 is located near the compressed air nozzle. This ensures that the compressed air carries away the cutting residue and does not cause the airflow to be blocked by the lower solid part of the fixture body 11, which would cause the airflow to blow back and drive the metal wire to move.

[0037] In some embodiments, the anastomotic staples are made of nickel-titanium alloy or magnesium-aluminum alloy. A metal wire is placed in the fixing hole 12. The laser focus point height of the laser cutting machine is adjusted to 0.4mm to ensure a uniform spot size that can penetrate a certain thickness of material. Combined with a specially designed wiring program, this ensures the drug-loaded groove meets the requirements of the drawings. After the drug-loaded groove is processed, the laser cutting machine cuts the tip of the anastomotic staple, selecting an intersection between the staple tip and the drug-loaded groove. This ensures that the drug-loaded groove of the staple, on the outer surface of the inner ring of the curved part, can more quickly contact the human tissue and release the antibacterial drug immediately.

[0038] Specifically, the spraying assembly 2 includes a mounting base 21, a mounting clamp 22 sleeved on the mounting base 21, and a protective tube 23 sleeved on the outer side of the mounting clamp 22. For example... Figure 3 As shown, the mounting base 21 includes a base 211 and a mounting rod 212. A threaded hole 2111 is provided at the bottom of the base 211 for fixed connection with the spraying equipment. The mounting rod 212 is a square rod for holding the mounting clamp 22. Pin holes are provided at one end of both the base 211 and the mounting rod 212 for mounting the entire mounting base 21. Figure 4 As shown, the mounting fixture 22 includes a mounting part 221, a limiting part 222 at one end, and mating holes 223 extending through both ends of the mounting fixture 22. The mounting part 221 is cylindrical, and mounting holes 224 are formed on the side of the bottom surface of the mounting part 221. The mounting holes 224 extend through both ends of the mounting part 221, and a portion of the side of the mounting holes 224 communicates with the outer surface of the mounting part 221. Multiple mounting holes 224 are formed and evenly arranged on the side of the mounting part 221. The mounting holes 224 are used to mount the cut straight metal wire and to position the drug-carrying groove of the straight metal wire on the outer surface of the mounting part 221 for easy spraying. The limiting part 222 has two symmetrical limiting grooves 2221 for mounting the protective tube 23. A flow channel 225 is also provided between the mounting part 221 and the limiting part 222. The flow channel 225 is an annular groove and communicates with the bottom of the mounting hole 225. The flow channel 225 is used to discharge excess liquid. The shape of the mating hole 223 is adapted to the mounting rod 212, so that the entire mounting clamp 22 can be fitted onto the mounting rod 212. Figure 5 As shown, the protective tube 23 includes a spray nozzle 231 on its outer surface and a limiting piece 232 at one end. Two limiting pieces 232 are symmetrically arranged and are adapted to the limiting groove 2221. The spray nozzles 231 are located on the outer surface of the protective tube 231, and the number of spray nozzles 231 is equal to the number of mounting holes 224. The positions of the spray nozzles 231 and mounting holes 224 correspond one-to-one. When the protective tube 231 is fitted onto the outer side of the mounting clamp 22, spraying the liquid medicine onto the spray nozzles 231 of the protective tube 231 allows the medicine to be sprayed into the medicine-carrying groove of the straight metal wire within the mounting hole 224.

[0039] like Figure 6 As shown, specifically, the nail-making assembly 3 includes a base 31, a nail disc 32 mounted on the base 31, and a nail presser 33. For example... Figure 7As shown, the base 31 includes a placement portion 311, a pressing groove 312 formed in the center of the placement portion 311, and mating grooves 313 provided on both sides of the placement portion 311. The placement portion 311 is located in the center of the base 31, and positioning grooves 3111 are provided at its four ends for placing the nail tray 32. The pressing groove 312 is a rectangular groove, and the bottom of the pressing groove 312 has rounded corners to prevent the matching nails from breaking during the nail making process. The mating grooves 313 are arc-shaped grooves, and there are two mating grooves 313, symmetrically arranged on both sides of the placement portion 311. Figure 8 , Figure 9 As shown, the staple tray 32 is placed on the base 31. The staple tray 32 includes a staple pressing opening 321 in the center of the staple tray 32, placement grooves 322 on both sides of the staple pressing opening 321, and positioning parts 323 at the bottom of the staple tray 32. The staple pressing opening 321 is rectangular, and its size matches the size of the staple pressing grooves 312. Multiple placement grooves 322 are provided, and they are vertically opened on both sides of the staple pressing opening 321. The placement grooves 322 are suitable for placing staples to be bent. Four positioning parts 323 are provided, fixed at the four corners of the bottom of the staple tray 32. The positioning parts 323 are adapted to the positioning grooves 3111, allowing the staple tray 32 to be stably placed above the base 31, preventing the staple tray 32 from moving during the staple making process. Figure 10 As shown, the nail presser 33 includes a top plate 331, mating parts 332 on both sides, and pressing blocks 333. The bottom of the top plate 331 is flat, and the mating parts 332 are adapted to the mating groove 313. The pressing blocks 333 are adapted to the size of the nail pressing opening 321 and are used to press and bend the matching nails located in the placement groove 322. The matching nails are placed in the placement groove 322, the nail tray 32 is placed on the base plate 31, and the pressing blocks 333 of the nail presser 33 are placed in the nail pressing opening 321 of the nail tray 32, applying positive pressure to the nail presser 33 to press the nails.

[0040] like Figure 11 As shown, the second embodiment of the present invention provides the steps of the manufacturing process for drug-loaded anastomotic staples used in the device during use:

[0041] Step S1: Grooves or holes are made in the metal wire using a laser cutting device, and the end of the metal wire is cut into a pointed structure to serve as the substrate for the drug-loaded anastomosis staple.

[0042] Specifically, the metal wire is slotted or perforated using a laser cutting height of 0.2-0.8 mm. The angle between the cut surface of the tip structure and the cylindrical surface of the metal wire is between 10-50°.

[0043] Step S2: Clean the drug-loaded anastomosis staple substrate obtained in step S1.

[0044] Specifically, the drug-loaded anastomotic staple matrix is ​​placed in a dispersion containing phosphoric acid and sulfuric acid at a temperature of 50°C and ultrasonically removed for 5-30 seconds. Then, it is placed in anhydrous ethanol and ultrasonically cleaned 3 times for 1 minute each time. Finally, the surface is dried with compressed air.

[0045] Step S3: The drug-loaded anastomosis staple substrate, cleaned in step S2, is fitted onto the spraying assembly, and while the spraying assembly drives the drug-loaded anastomosis staple substrate to rotate, a spraying solution containing antibacterial drugs and polymer carriers is sprayed onto the drug-loaded anastomosis staple substrate.

[0046] Specifically, the spraying method is ultrasonic spraying, with an ultrasonic power of 1-2W, a spray solution flow rate of 0.01-0.1mL / min, a fixture rotation speed of 200-1000r / min, and 5-10 spraying revolutions. The spray solution contains one or more of the following solvents: tetrahydrofuran, dichloromethane, acetone, methanol, and concentrated ammonia; the antibacterial drug content is 10-100mg / mL; and the polymeric carrier content is 10-20mg / mL.

[0047] Step S4: The drug-loaded anastomosis staple substrate obtained in step S3 is coated and then formed into a U-shaped staple on a staple forming fixture, which is the drug-loaded anastomosis staple.

[0048] Specifically, the grooves or holes on the sprayed drug-loaded anastomotic staple substrate are fitted onto the staple forming fixture in the bending direction, a pressure of 40N is applied, and the pressure is released after 3-5 seconds to complete the staple making.

[0049] In some examples, the steps of the drug-eluting staple fabrication process used in the device are as follows:

[0050] Step S1: Select a nickel-titanium alloy wire with a diameter of 0.28mm and feed it into the laser cutting equipment. Use the cutting and grooving fixture 1 to fix the metal wire. The laser cutting height is 0.2mm. Make a straight drug-carrying groove with a groove width of 90μm and a groove depth of 50μm according to the cutting drawing. Then cut out drug-carrying staples with pointed tips and select the tip of the staple to intersect with the straight drug-carrying groove.

[0051] Step S2: Place the staples in a residue solution with a volume ratio of phosphoric acid: sulfuric acid: purified water = 7:3:10 and sonicate for 5 seconds to remove residue. The water temperature is controlled at 50℃. Then, place them in anhydrous ethanol and sonicate for 3 times, 1 minute each time. Finally, dry the surface with compressed air.

[0052] Step S3: Load the staples onto the spraying assembly 2. Prepare a concentrated ammonia solution of silver sulfadiazine and a tetrahydrofuran solution of polylactic acid-glycolic acid copolymer (PLGA) as the spraying solution, with concentrations of 10 mg / mL and 10 mg / mL, respectively. Set the spraying parameters as follows: ultrasonic power 1W, ultrasonic spraying solution flow rate 0.01 mL / min, fixture rotation speed 200 r / min, spraying revolutions 5, and dry after spraying.

[0053] Step S4: Place the dried drug-loaded anastomotic staples onto the staple-making assembly 3 to form U-shaped staples.

[0054] In other examples, the steps of the drug-eluting staple fabrication process used in this device are as follows:

[0055] Step S1: Select a nickel-titanium alloy wire with a diameter of 0.21mm and feed it into the laser cutting equipment. Use the cutting and grooving fixture 1 to fix the metal wire. The laser cutting height is 0.8mm. Make a straight drug-carrying groove with a groove width of 70μm and a groove depth of 40μm according to the cutting drawing. Then cut out drug-carrying staples with pointed tips and select the tip of the staple to intersect with the straight drug-carrying groove.

[0056] Step S2: Place the staples in a residue solution with a volume ratio of phosphoric acid: sulfuric acid: purified water = 7:3:10 and sonicate for 30 seconds to remove residue. The water temperature is controlled at 50℃. Then, place them in anhydrous ethanol and sonicate for 3 times, 1 minute each time. Finally, dry the surface with compressed air.

[0057] Step S3: Load the staples onto the spraying assembly 2, and prepare a methanol solution of rifampicin and a tetrahydrofuran solution of poly(D,L-lactide) (PDLLA) as the spraying solution, with concentrations of 100 mg / mL and 20 mg / mL, respectively. Set the spraying parameters as follows: ultrasonic power 1.6 W, ultrasonic spraying solution flow rate 0.1 mL / min, fixture rotation speed 1000 r / min, and 10 spraying cycles. After spraying, dry the product.

[0058] Step S4: Place the dried drug-loaded anastomotic staples onto the staple-making assembly 3 to form U-shaped staples.

[0059] In other examples, the steps of the drug-eluting staple fabrication process used in this device are as follows:

[0060] Step S1: Select a nickel-titanium alloy wire with a diameter of 0.21mm and feed it into the laser cutting equipment. Fix the metal wire with the cutting and grooving fixture 1. The laser cutting height is 0.35mm. Make a straight drug-carrying groove with a groove width of 70μm and a groove depth of 40μm according to the cutting drawing. Then cut out drug-carrying staples with pointed tips and select the tip of the staple to intersect with the straight drug-carrying groove.

[0061] Step S2: Place the staples in a slurry containing phosphoric acid: sulfuric acid: purified water in a volume ratio of 7:3:10 and sonicate for 30 seconds to remove the residue. The water temperature is controlled at 50℃. Then, place them in anhydrous ethanol and sonicate for 3 times, 1 minute each time. Finally, dry the surface with compressed air.

[0062] Step S3: Load the staples onto the spraying assembly 2. Prepare a concentrated ammonia solution of silver sulfadiazine and a tetrahydrofuran solution of rifampicin and polylactic acid-glycolic acid copolymer (PLGA) as the spraying solution, with concentrations of 33 mg / mL, 14 mg / mL and 10 mg / mL, respectively. Set the spraying parameters as follows: ultrasonic power 2W, ultrasonic spraying concentrated ammonia solution flow rate 0.015 mL / min, tetrahydrofuran solution flow rate 0.035 mL / min, fixture rotation speed 300 r / min, spraying revolutions 8, and dry after spraying.

[0063] Step S4: Place the dried drug-loaded anastomotic staples onto the staple-making assembly 3 to form U-shaped staples.

[0064] The drug-loaded anastomosis staple manufacturing process of the present invention includes: grooving or drilling a metal wire using a laser cutting device, and cutting the end of the metal wire into a pointed structure to serve as the drug-loaded anastomosis staple substrate; cleaning the obtained drug-loaded anastomosis staple substrate; mounting the cleaned drug-loaded anastomosis staple substrate onto a spraying assembly, and spraying the drug-loaded anastomosis staple substrate with a spraying solution containing antibacterial drugs and polymer carriers while the spraying assembly drives the drug-loaded anastomosis staple substrate to rotate; and forming the resulting sprayed drug-loaded anastomosis staple substrate into a U-shaped staple on a staple forming fixture, which is the drug-loaded anastomosis staple. The present invention has a drug-loaded groove on the anastomosis staple, and the drug is sprayed into the drug-loaded groove. During use, the drug-loaded anastomosis staple continuously releases the drug through the staple feet, accelerating wound healing.

[0065] Based on the above-described preferred embodiments of the present invention, and through the foregoing description, those skilled in the art can make various changes and modifications without departing from the scope of the present invention. The technical scope of this invention is not limited to the contents of the specification, but must be determined according to the scope of the claims.

Claims

1. A manufacturing process for drug-eluting anastomotic staples, characterized in that, Includes the following steps: S1: Grooves or holes are made in the metal wire using a laser cutting device, and the end of the metal wire is cut into a pointed structure to serve as the substrate for drug-loaded anastomosis staples; S2: Clean the drug-loaded anastomosis staple substrate obtained in step S1; S3: The drug-loaded anastomosis staple substrate cleaned in step S2 is fitted onto the spraying assembly, and while the spraying assembly drives the drug-loaded anastomosis staple substrate to rotate, the drug-loaded anastomosis staple substrate is sprayed with a spraying solution containing antibacterial drugs and polymer carriers. S4: The drug-loaded anastomosis staple substrate obtained in step S3 is coated and then formed into a U-shaped staple on a staple forming fixture, which is the drug-loaded anastomosis staple.

2. The processing technology for drug-loaded anastomotic staples according to claim 1, characterized in that, In S1, the metal wire is slotted or perforated by laser cutting at a height of 0.2-0.8mm.

3. The processing technology for drug-eluting anastomotic staples according to claim 1, characterized in that, In S1, the angle between the cut surface of the tip structure and the cylindrical surface of the metal wire is between 10 and 50°.

4. The processing technology for drug-loaded anastomotic staples according to claim 1, characterized in that, In step S2, the drug-loaded anastomotic staple matrix is ​​placed in a dispersion containing phosphoric acid and sulfuric acid at a temperature of 50°C and ultrasonically removed for 5-30 seconds. Then, it is placed in anhydrous ethanol and ultrasonically cleaned 3 times for 1 minute each time. Finally, the surface is dried with compressed air.

5. The processing technology for drug-eluting anastomotic staples according to claim 4, characterized in that, In S3, the spraying method is ultrasonic spraying, the ultrasonic power is 1-2W, the spraying solution flow rate is 0.01-0.1mL / min, the fixture rotation speed is 200-1000r / min, and the number of spraying revolutions is 5-10 revolutions.

6. The processing technology for drug-eluting anastomotic staples according to claim 5, characterized in that, In S3, the solvent in the spraying solution is one or a combination of two or more of tetrahydrofuran, dichloromethane, acetone, methanol, and concentrated ammonia, the antibacterial drug content is 10-100 mg / mL, and the polymer carrier content is 10-20 mg / mL.

7. The processing technology for drug-loaded anastomotic staples according to claim 1, characterized in that, In step S4, the grooves or holes on the sprayed drug-loaded anastomotic staple substrate are fitted onto the staple forming fixture in the direction of bending, a pressure of 40N is applied, and the pressure is released after 3-5 seconds to complete the staple making.

Citation Information

Patent Citations

  • Nail abutting seat assembly of disposable endoscope inner cutting anastomat and manufacturing method thereof

    CN107714121A

  • Bone staple, instrument and method of use and manufacturing

    US20130030437A1