CN210124874U

CN210124874U - Pulling and shaping degradable implantation wire and surgical needle thereof

Info

Publication number: CN210124874U
Application number: CN201920641878.1U
Authority: CN
Inventors: 夏佩佩; 晏伟; 魏征
Original assignee: Yipurun (shanghai) Biotechnology Co Ltd
Current assignee: Yipurun (shanghai) Biotechnology Co Ltd
Priority date: 2019-05-07
Filing date: 2019-05-07
Publication date: 2020-03-06
Anticipated expiration: 2029-05-07

Abstract

The utility model relates to a carry and draw moulding degradable implantation line has integrative silk thread body and cantilever structure, and the silk thread body has radially towards the inboard sunken opening of recessed and from the fluting of opening axial from the peripheral surface, and cantilever structure includes covers the fluting and follows the silk thread body towards the inverted structure that the opening axial was stretched out in the grooved top, and the end that keeps away from the free end of inverted structure forms the tooth root, and the fluting position of silk thread body below the tooth root is formed with the circular arc chamfer. The utility model also provides an including foretell carry draw moulding degradable implant line's operation needle, including connecting in carrying the syringe needle of drawing moulding degradable implant line, cantilever structure stretches out in the syringe needle dorsad. The utility model discloses a carry and draw moulding degradable implantation line, through impressing out the sawtooth and forming on a complete degradable silk thread, the cantilever that forms this sawtooth is difficult for splitting. Moreover, through the design of the saw teeth, the strength of the wire can be kept to the maximum extent while the lifting force of the cantilever is improved, and the lifting effect is better shown.

Description

Pulling and shaping degradable implantation wire and surgical needle thereof

Technical Field

The utility model relates to a line is implanted in the operation, more specifically relates to a draw moulding degradable implant line of moulding and operation needle thereof.

Background

In recent years, the development of the medical and beauty industry is rapid, and the medical and beauty industry is particularly embodied in a pulling operation for improving the skin firmness. Effectively improving the problem of skin relaxation and aging, is one of the fields in which medical equipment manufacturers want to develop innovation at present. Pulling the suture is an important tool for pulling surgery, and the suture needle advances the thread into the tissue to close the wound and hold the tissue together to support healing and regrowth.

The pull suture, which is currently common in the industry, is typically a barbed wire, which is a unidirectional suture having a pointed leading end and a plurality of axially and circumferentially spaced barbs on the outer surface of the elongated body. These barbs typically spread along the elongated body, thereby tending to cause unwanted damage to the tissue. Moreover, the barb line is usually processed in a cold mode, teeth are cut through a single-piece cutter, and the phenomena of sawtooth breakage, tooth overturning and the like are easy to occur in the stress process of the product, so that the lifting effect is lost.

Some sawtooth lines which are formed by hot-pressing injection molding are also arranged on the market, and the phenomena of sawtooth fracture, tooth overturning and the like are avoided, but because the sawtooth lines are low in stress strength and high in hardness, the phenomena that line body fracture occurs easily or implantation is difficult to pass through in the operation process, and discomfort of operators is caused.

SUMMERY OF THE UTILITY MODEL

In order to solve the problem that the suture line is easy to crack by barbs, turn over teeth, break the line body and the like in the lifting process, the utility model aims to provide a plastic degradable implanted line and an operation needle thereof.

The utility model provides a carry and draw moulding degradable implantation line has integrative silk thread body and cantilever structure, and this silk thread body has from its peripheral surface radial towards the inboard sunken opening of line and from the sunken fluting of opening axial, and cantilever structure includes covers the fluting and follows silk thread body towards the structure of hanging upside down that the opening axial was stretched out in the slotted top, and the end of keeping away from the free end of hanging upside down forms the tooth root, and the silk thread body is formed with the circular arc chamfer in the fluting position of tooth root below.

According to the utility model discloses a carry and draw moulding degradable and implant line, it is formed by the production of a complete degradable silk thread, through punching press (impression promptly) silk thread body and form the sawtooth structure on the silk thread body, this sawtooth structure is defined by crisscross cantilever structure and the unsmooth form of open-ended, not only the difficult fracture of cantilever and the tooth that turns over, can furthest keep the intensity of the line body in addition when improving the cantilever and carrying tensile force, the line body fracture can not take place. The wire body and the cantilever structure are of an integral structure, and the cantilever structure basically does not protrude out of the diameter of the wire body. The expression "substantially" here means that although the serrations may slightly protrude from the thread body during actual processing due to the punching force of the die on the thread body, they do not substantially protrude from the thread body as a whole, thereby avoiding the problem of damage to the weave of the barbed thread of the prior art. Particularly, the utility model discloses a carry and draw moulding degradable implantation line reduces the influence of sawtooth processing to line body intensity through the circular arc chamfer below the tooth root to avoid the reduction of the intensity of silk thread body, carry and draw the fracture of process silk thread.

The pull-up shaped degradable implant thread is selected from the group consisting of a thread formed from: chitosan, gelatin, algin, starch, hyaluronic acid, cellulose and derivatives thereof, polylactide-glycolide, polyglycolide, polylactic acid (PLA), L-polylactic acid (PLLA), D-polylactic acid (PDLA), polyvinyl alcohol, polyvinylpyrrolidone (PVP), polylactic-co-glycolic acid (PLGA), polyethylene glycol (PEG), Polycaprolactone (PCL), polyorthoester, polyglycolic acid (PGA), Polydioxanone (PDO), and one or more of copolymerization or blending.

The radius range of the arc chamfer is 0.05mm-2 mm. In a preferred embodiment, the radius of the rounded chamfer is 0.06mm-0.7 mm.

The wire diameter of the lifting shaping degradable implantation wire is 0.1mm-10 mm. Preferably, the wire diameter is 0.3mm to 5 mm. In a preferred embodiment, the wire diameter is 0.6mm to 2 mm.

It should be appreciated that the root width and thickness determine the strength of the cantilever. Preferably, the root width is 10% -100%, preferably 50% -100%, of the wire diameter; the thickness of the tooth root is 5% -60%, preferably 10% -40% of the wire diameter. In a preferred embodiment, the root width is 0.3mm to 1mm, which is 50% of the wire diameter, and the root thickness is 0.1mm to 0.6mm, which is 17% to 30% of the wire diameter.

It will be appreciated that the radial depth and axial length of the opening determine the amount of tissue that the cantilever can pull. Preferably, the radial depth of the opening is 10% -100%, preferably 50% -100%, of the wire diameter; the axial length of the opening is 0.05mm to 5mm, preferably 0.1mm to 2 mm. In a preferred embodiment, the radial depth of the opening is 0.3mm to 1mm, which is 50% of the wire diameter, and the axial length of the opening is 0.8mm to 2 mm.

The cantilever structure comprises a plurality of rows of inverted hanging structures distributed on the cross section of the silk thread at included angles of 90-180 degrees, and each row of inverted hanging structures comprises a plurality of cantilevers. For example, the distribution angle of each row of inverted structures along the circumference of the line may be 90 °, 120 °, 180 °.

The cantilever is triangular, trapezoidal or rectangular.

The cantilevers and the openings are alternately arranged to form a concave-convex sawtooth structure, and the axial distance (also called staggered distance) between adjacent sawteeth is 0.05mm-7 mm. Preferably, the axial spacing is 0.1mm to 2 mm. In a preferred embodiment, the axial spacing is 0.2mm to 0.5 mm.

The silk thread body is provided with arc chamfers at the highest position C and the lowest position of the opening.

The utility model also provides an including foretell carry draw moulding degradable implant line's operation needle, including connecting in carrying the syringe needle of drawing moulding degradable implant line one end, cantilever structure stretches out in this syringe needle dorsad.

The surgical needle comprises a first needle head and a second needle head, one part of the cantilever structure extends out back to the first needle head, and the other part of the cantilever structure extends out back to the second needle head. It should be understood that the cantilever structures herein may be segmented in the same or opposite directions along the axial direction (lengthwise direction) of the surgical needle.

The utility model discloses a carry and draw moulding degradable implantation line, it forms through impressing out the sawtooth on a complete degradable silk thread, forms the difficult fracture of cantilever of this sawtooth from this. Moreover, through the design of the saw teeth, the strength of the wire can be kept to the maximum extent while the lifting force of the cantilever is improved, and the lifting effect is better shown.

Drawings

Fig. 1 is an overall schematic view of a surgical needle including a lift-molded degradable implant thread according to a preferred embodiment of the present invention;

FIG. 2 is an enlarged view of a portion of FIG. 1;

fig. 3 is a partial enlarged view of a lift-molded degradable implant line according to a preferred embodiment of the present invention;

FIG. 4 is an enlarged view of the radiused chamfer of FIG. 3;

FIG. 5 shows the cantilever of embodiment 1;

fig. 6 shows the cantilever of embodiment 3.

Detailed Description

The following description of the preferred embodiments of the present invention will be made with reference to the accompanying drawings.

Fig. 1 shows a surgical needle used in a pulling and lifting surgical procedure, which comprises a first needle head 1, a second needle head 2 and a pulling and shaping degradable implantation wire 3 according to a preferred embodiment of the present invention, wherein the pulling and shaping degradable implantation wire 3 is connected and fixed between the first needle head 1 and the second needle head 2.

Specifically, the lift-molded degradable implant thread 3 comprises a first lift-molding part 31, a second lift-molding part 32 and a connecting part 33, wherein the first lift-molding part 31 is fixedly connected with the first needle 1, the second lift-molding part 32 is fixedly connected with the second needle 2, and the connecting part 33 is fixedly connected between the first lift-molding part 31 and the second lift-molding part 32. The first pulling portion 31 has a first cantilever structure projecting away from the first needle 3, and the second pulling portion 32 has a second cantilever structure projecting away from the second needle 2. Thus, when the first and

second needles

1, 2 advance along the direction X for operation, the first and second cantilever structures do not hinder the implantation of the pulling-up plastic degradable implantation line 3 because the extension direction is opposite to the direction X; after the operation is finished, the lifting and shaping degradable implantation wire 3 is hung on the tissue by means of the first and second cantilever structures to keep the lifting and shaping state of the tissue.

Fig. 2 is a partially enlarged view of the first lifting portion of fig. 1, the first cantilever structure of the first lifting portion 31 is a two-row embossed inverted structure formed by symmetrically stamping the outer peripheral surface 31a of the wire through a die, and the top first inverted structure 311 and the bottom second inverted structure 312 are arranged at an angle of 180 ° in the cross section of the wire. In addition, unlike fig. 1, the first needle 1 is also shown in fig. 2 as being curved.

Fig. 3 is a partial enlarged view of fig. 2, the lift-molded degradable implant wire 3 having a wire diameter D1, and a punching depth of a die D2 (radial direction) in a cross section of the wire, thereby forming an opening O1 recessed from the outer peripheral surface 31a of the wire toward the inside of the wire, the opening O1 having an axial length of L1; meanwhile, the punching length of the die in the lengthwise direction (axial direction) of the wire is greater than the axial length L1 of the opening O1, forming a notch O2 axially recessed from the opening O1, the notch O2 being defined by a cantilever, the depth of the notch O2 being the difference between the punching depth D2 and the cantilever thickness D3. The cantilever is an inverted structure covering the slot O2, the end of the inverted structure far from the free end, i.e. the end connected to the wire body, is formed as a tooth root a, and the wire body is formed with a circular arc chamfer at the slot O2 position B below the tooth root a. In a preferred embodiment, the wire body is formed with a rounded chamfer at both the highest position C and the lowest position D of the opening O1. The axial spacing between adjacent teeth along the lengthwise direction of the wire is L2.

FIG. 4 is an enlarged view of the radiused chamfer of FIG. 3 showing the radius R of the radiused chamfer.

Example 1

The pulling-shaping degradable implantation line is a PLLA silk thread, the diameter D1 of the line is 0.6mm, two adjacent rows of inverted structures are distributed at an included angle of 180 degrees, the axial distance L2 between adjacent sawteeth is 0.2mm, a cantilever of the inverted structure 311a is triangular in a lateral cross-sectional view (as shown in figure 5), the width of a tooth root (the extension length on the circumferential surface) is 0.3mm, the thickness D3 of the tooth root is 0.1mm, the opening depth D2 is 0.3mm, the opening length L1 is 0.8mm, and the radius R of an arc chamfer is 0.06 mm.

The barbed wire of the same wire diameter on the market was taken as a comparative sample.

Polyurethane sponge material is used for simulating skin, a thread is embedded in the simulated skin, and certain pressure is applied. The force value of the wire pulling out the tissue is tested by using a universal material testing machine, and the force value can represent the wire pulling force performance. Specifically, the test pulling force of the pulling-up molding degradable implantation wire of the embodiment is 16N, and after pulling out, the cantilever is observed to have no phenomena of fracture and tooth overturning; the pulling force is 9N for the test of barb line on the market, and it is not cracked to observe the barb after pulling out, has 50% tooth phenomenon of turning over.

A universal material testing machine is used for testing the strength and the tensile breaking force. Specifically, the test breaking force of the pull-up molding degradable implant line of the present embodiment is 19N; the tested breaking force of the commercial barbed wire was 27N.

According to the normal facial expression process, the dynamic acting force of facial muscles is not more than 5N, the pulling force and the breaking force of the pulling and shaping degradable implantation wire are both more than 5N, and the operation requirements are met. Moreover, compared with the barb line which is possibly turned into teeth on the market, the pulling and shaping degradable implant line of the embodiment has no phenomena of fracture and tooth turning.

Example 2

The pulling and shaping degradable implantation line is a PLLA silk thread, the diameter D1 of the line is 0.8mm, two adjacent rows of inverted hanging structures are distributed at an included angle of 180 degrees, the axial distance L2 between adjacent sawteeth is 0.3mm, a cantilever is triangular in a lateral sectional view, the width of a tooth root is 0.4mm, the thickness D3 of the tooth root is 0.2mm, the opening depth D2 is 0.4mm, the opening length L1 is 0.8mm, and the radius R of an arc chamfer is 0.12 mm.

Polyurethane sponge material is used for simulating skin, a thread is embedded in the simulated skin, and certain pressure is applied. The force value of the wire pulling out the tissue is tested by using a universal material testing machine, and the force value can represent the wire pulling force performance. Specifically, the test pulling force of the pulling-up molding degradable implant line of the embodiment is 17N, and after pulling out, the cantilever is observed to have no fracture and tooth overturning phenomenon.

A universal material testing machine is used for testing the strength and the tensile breaking force. Specifically, the test breaking force of the pull-up molded degradable implant wire of the present embodiment is 19N.

According to the normal facial expression process, the dynamic acting force of facial muscles is not more than 5N, the pulling force and the breaking force of the pulling and shaping degradable implantation wire are both more than 5N, and the operation requirements are met. Moreover, the lifting shaping degradable implant wire of the embodiment has no phenomena of fracture and tooth overturning.

Example 3

The pulling and shaping degradable implantation line is a PLGA silk line, the line diameter D1 is 2mm, two adjacent rows of inverted hanging structures are distributed at an included angle of 120 degrees, the axial distance L2 between the adjacent sawteeth is 0.5mm, a cantilever of the inverted hanging structure 311b is trapezoidal in a lateral cross-sectional view (as shown in figure 6), the tooth root width is 1mm, the tooth root thickness D3 is 0.6mm, the opening depth D2 is 1mm, the opening length L1 is 2mm, and the arc chamfering radius R is 0.7 mm.

The same diameter of the sawtooth line on the market was taken as a comparative sample.

Polyurethane sponge material is used for simulating skin, a thread is embedded in the simulated skin, and certain pressure is applied. The force value of the wire pulling out the tissue is tested by using a universal material testing machine, and the force value can represent the wire pulling force performance. Specifically, the test pulling force of the pulling-up molding degradable implantation wire is 25N, and after pulling out, the cantilever is observed to have no phenomena of fracture and tooth overturning; the pulling force of the test of the sawtooth line on the market is 20N, and the sawtooth is observed to have no fracture and tooth overturning phenomenon after being pulled out.

A universal material testing machine is used for testing the strength and the tensile breaking force. Specifically, the test breaking force of the pull-up molding degradable implant line of the embodiment is 30N; the test breaking force of the sawtooth line on the market is 23N.

Comparative example 1

The only difference from example 1 is that the axial spacing L2 between adjacent serrations was 0.04 mm.

Polyurethane sponge material is used for simulating skin, a thread is embedded in the simulated skin, and certain pressure is applied. The force value of the wire pulling out the tissue is tested by using a universal material testing machine, and the force value can represent the wire pulling force performance. Specifically, the test pulling force of the pulling-up molding degradable implant wire of the embodiment 1 is 16N, and after pulling out, the cantilever is observed to have no phenomena of fracture and tooth overturning; the test pull-up force of the nip of comparative example 1 was 7N.

A universal material testing machine is used for testing the strength and the tensile breaking force. Specifically, the test breaking force of the pull-up molded degradable implant wire of example 1 was 19N; the test breaking force of the nip of comparative example 1 was 3.5N.

The dynamic force of facial muscles according to the normal facial expression process does not exceed 5N, and the fracture force of the nip of comparative example 1 is less than 5N, so that the nip is easy to fracture and cannot meet the requirements of the operation.

Comparative example 2

The only difference from example 1 is that the axial spacing L2 between adjacent serrations was 8 mm.

Polyurethane sponge material is used for simulating skin, a thread is embedded in the simulated skin, and certain pressure is applied. The force value of the wire pulling out the tissue is tested by using a universal material testing machine, and the force value can represent the wire pulling force performance. Specifically, the test pulling force of the pulling-up molding degradable implant wire of the embodiment 1 is 16N, and after pulling out, the cantilever is observed to have no phenomena of fracture and tooth overturning; the test pull-up force of the nip of comparative example 2 was 4N.

A universal material testing machine is used for testing the strength and the tensile breaking force. Specifically, the test breaking force of the pull-up molded degradable implant wire of example 1 was 19N; the test breaking force of the nip of comparative example 2 was 23N.

The dynamic acting force of facial muscles in the normal facial expression process is not more than 5N, the lifting force of the nip of the comparative example 2 is less than 5N, and the post-operation lifting state cannot be ensured, namely the operation requirement cannot be met.

Comparative example 3

The only differences from example 1 are a root width of 0.05mm, a root thickness D3 of 0.02mm, an opening depth D2 of 0.05mm and an opening length L1 of 0.04 mm.

Polyurethane sponge material is used for simulating skin, a thread is embedded in the simulated skin, and certain pressure is applied. The force value of the wire pulling out the tissue is tested by using a universal material testing machine, and the force value can represent the wire pulling force performance. Specifically, the test pulling force of the pulling-up molding degradable implant wire of the embodiment 1 is 16N, and after pulling out, the cantilever is observed to have no phenomena of fracture and tooth overturning; the test pull-up force of the nip of comparative example 3 was 4.5N, and after pulling out, the cantilever was observed to be 30% broken and 60% tooth-flipping.

A universal material testing machine is used for testing the strength and the tensile breaking force. Specifically, the test breaking force of the pull-up molded degradable implant wire of example 1 was 19N; the test breaking force of the nip of comparative example 3 was 25N.

The dynamic acting force of facial muscles in the normal facial expression process is not more than 5N, the lifting force of the nip of the comparative example 3 is less than 5N, and the post-operation lifting state cannot be ensured, namely the operation requirement cannot be met. Moreover, the nip of comparative example 3 had breakage and tooth-flipping phenomena.

Comparative example 4

The only differences from example 1 are 0.6mm root width, 0.4mm root thickness D3, 0.6mm opening depth D2 and 2.5mm opening length L1.

Polyurethane sponge material is used for simulating skin, a thread is embedded in the simulated skin, and certain pressure is applied. The force value of the wire pulling out the tissue is tested by using a universal material testing machine, and the force value can represent the wire pulling force performance. Specifically, the test pulling force of the pulling-up molding degradable implant wire of the embodiment 1 is 16N, and after pulling out, the cantilever is observed to have no phenomena of fracture and tooth overturning; the test pull up force of the nip of comparative example 4 was 4.5N and the wire was stretch broken.

A universal material testing machine is used for testing the strength and the tensile breaking force. Specifically, the test breaking force of the pull-up molded degradable implant wire of example 1 was 19N; the test breaking force of the nip of comparative example 3 was 7.5N.

The dynamic force of facial muscles according to the normal facial expression process is not more than 5N, the lifting force of the nip of the comparative example 4 is less than 5N, and the post-operation lifting state cannot be ensured, namely the operation requirement cannot be met.

What has been described above is only the preferred embodiment of the present invention, not for limiting the scope of the present invention, but various changes can be made to the above-mentioned embodiment of the present invention. All the simple and equivalent changes and modifications made according to the claims and the content of the specification of the present invention fall within the scope of the claims of the present invention. The present invention is not described in detail in the conventional technical content.

Claims

1. A pulling plastic degradable implant line is characterized in that the pulling plastic degradable implant line is provided with an integrated wire body and a cantilever structure, the wire body is provided with an opening which is recessed towards the inside of the line from the radial direction of the outer peripheral surface of the wire body and a groove which is recessed from the axial direction of the opening, the cantilever structure comprises an inverted hanging structure which covers the groove above the groove and axially extends out from the wire body towards the opening, the tail end of the inverted hanging structure far away from the free end is formed into a tooth root, and the groove position of the wire body below the tooth root is formed with a circular arc chamfer.

2. The lift-molding degradable implant line of claim 1, wherein the radius of the rounded chamfer ranges from 0.05mm to 2 mm.

3. The lift-molded degradable implant string of claim 1, wherein the diameter of the lift-molded degradable implant string is 0.1mm to 10 mm.

4. The lift-molded degradable implant line of claim 3, wherein the root width is 10% to 100% of the wire diameter and the root thickness is 5% to 60% of the wire diameter.

5. The lift-molded degradable implant line of claim 3, wherein the radial depth of the opening is 10% to 100% of the line diameter; the axial length of the opening is 0.05mm-5 mm.

6. The lift-molding degradable implant line of claim 1, wherein the cantilever structure comprises a plurality of rows of inverted structures distributed at an included angle of 90 ° -180 ° on the cross section of the wire, each row of inverted structures comprising a plurality of cantilevers.

7. The lift-molding degradable implant line of claim 6, wherein the cantilevers and the openings are alternately arranged to form a concave-convex saw-tooth structure, and the axial distance between adjacent saw teeth is 0.05mm-7 mm.

8. The lift-molding degradable implant line of claim 1, wherein the wire body is formed with a rounded chamfer at both the highest position C and the lowest position of the opening.

9. A surgical needle comprising a pull-up molded degradable implant thread according to any one of claims 1 to 8, characterized in that the surgical needle comprises a needle head connected to one end of the pull-up molded degradable implant thread, the cantilever structure protruding away from the needle head.

10. The surgical needle of claim 9, wherein the surgical needle comprises a first needle tip and a second needle tip, a portion of the cantilevered structure extending away from the first needle tip and another portion of the cantilevered structure extending away from the second needle tip.