KR810001953B1 - Surgical Suture - Google Patents

Abstract

No content.

Description

Surgical Suture

The present invention relates to an absorbent or nonabsorbable surgical stitch which improves the downward movement properties of the knot and reduces tissue disturbances, the stitching being comprised of a multi-threaded polymer twist and a thin coating of the lubricity absorbent copolymer thereon. have.

The lubricity copolymer consists of polyoxyethylene blocks and polyoxypropylene blocks to facilitate downward movement and handling, and the bioabsorbable copolymer has a molecular weight such that it is kneaded to a solid state at 25 ° C.

Lubricatable sheaths are approximately 0.1-25% by weight of the uncoated braids, based on the weight of the uncoated braids forming the stitches, so that the friction of friction is sufficiently reduced so that the angular knots sew the yarn. By adjusting the edge of the wound.

The present invention also relates to a method of stitching the upper body to a living tissue, in which the edge of the wound in the living tissue is stitched with a surgical stitch with the lubricity coating, the stitch is tied with a angular knot, and the angular knot is woven into the tissue. Move down near the desired location, add extra strands to the angular knot, and bioabsorb and remove the lubricity absorbent copolymer from the stitch within about 48 hours to increase the safety of the knot and increase the safety of the absorbent surgical stitch. The case is left in the living tissue to allow the living tissue to absorb the strands of stitching during the healing process, in which the stitching provides tissue traction for at least 15 days and the absorption is substantially complete within 90 days In the case of dragon sewing, leave the tissue intact to reinforce the tissue.

One of the important handling characteristics of surgical stitches is that associated with the downward movement of the knot. One widely used method is to tie a angular knot first in an external location and then move the knot down to touch the tissue and tighten it to the desired extent. Move the knot down and hold it to the extent desired by your doctor, depending on your particular situation, and tie the separate strands to the angular knots. In some cases, the strands of the angular knot are initially single-stranded and then twisted in duplicate to form separate angular knots as separate strands as necessary.

In contrast to the ease of movement of the knot there is a need for stability of the knot. It is hoped that it is easy to tie a knot, but this knot needs to be kept unslip for the allowable time.

Some sewing materials are so smooth that the knot can easily loosen as a result of the knot's downward movement. The material of the other sewing thread is difficult to move the strands down and touch the tissue because the knot is fixed and refuses downward movement, in which case only a few strands are needed and stability is not a problem. Knots in tissues that are constantly in motion, such as near the heart, are much more likely to loosen than knots in stationary tissues, such as wounds in plaster gibs.

It is generally well known to coat, color and control surgical stitching with polymeric materials. Silica, waxes, polytetrafluoroethylene and other polymers have been used.

However, specific coating materials have been explored to make improved sewing threads with unique advantages.

Surgical sewing threads with improved knot downward migration properties and reduced tissue disturbances of the present invention consist of a multithreaded polymer twisted yarn, which is thinly coated with a lubricious bioabsorbable copolymer. The lubricity copolymer is made of polyoxyethylene block and polyoxypropylene block to facilitate downward movement and handling, and the bioabsorbable copolymer has a molecular weight to form a dough to a solid form at 25 ℃.

As one specific example, the lubricity bioabsorbable copolymer has the structure

Wherein one of R ₁ and R ₂ is methyl and the other is hydrogen, n and m are sufficiently large that the compound is kneaded to solid form at 25 ° C. and R is the residue of a relatively low molecular weight reactive hydrogen compound There are 2 to 6 reactive hydrogen atoms and no more than 6 carbon atoms, and C is the number of reactive hydrogens in the compound forming R.

As another specific example, the polymer string is a tissue absorbent polymer, which is hydrolyzed to a nontoxic absorbent component that can coexist with the tissue and the polymer also has glycolic acid ester linkages.

As another specific example, the polymer string is selected from the group consisting of silk, cotton, nylon, nonabsorbable polyester, polypropylene, polyethylene, and the like.

Lubricatable sheath is about 0.1 to 25% by weight of the uncoated twisted line, based on the weight of the uncoated twisted line forming the stitch, so that the friction of friction is sufficiently reduced so that the angular knot moves on the stitch. To adjust the edges of the wound.

The method of sewing a wound to a living tissue is to sew the edge of the wound of the living tissue with a surgical sewing thread with the above-mentioned lubricity coating, tie the sewing thread into a angular knot, and move the angular knot down to the desired position of the tissue. Place a separate strand in the angular knot, increase the safety of the knot by bioabsorbing and removing the lubricious absorbent copolymer from the stitch within about 48 hours, and in the case of absorbent surgical stitching, the stitching string is the healing process. The tissue is left in the biological tissue until it is absorbed into the biological tissue, where the stitching provides tissue traction for at least 15 days and the absorption is substantially complete within 90 days, and in the case of nonabsorbable surgical stitching Have the organization reinforce the organization.

Current marketable absorbent stitches are glycolic acid ester bonds that are hydrolyzed and absorbed into the tissue. The invention can also be used for other synthetic absorbent surgical stitches known in the art. In synthetic absorbent stitching, it is more difficult to improve the knot's downward movement properties by coating because of the requirement that the coating be non-toxic and absorbent.

Non-absorbent stitches are those that remain undigested in living tissue unless removed or pushed surgically. Nonabsorbable stitching provides support to living tissue for a long time, and sometimes for life. Non-absorbent stitches for stitching the skin to make knots on the surface of the skin are removed by the doctor at appropriate stages of the healing process. If the knot of the nonabsorbable stitching thread remains embedded in the living tissue, the lubricant is absorbed from the nonabsorbable stitching thread within about 48 hours, so that the lubrication is stopped and the safety of the knot is improved.

Nonabsorbent stitching is usually made of silk, cotton, nylon, nonabsorbent polyester, polypropylene, polyethylene, or linen. Metals such as stainless steel, tantalum and platinum in the form of single-threaded or braided thread have also been used.

The term absorbent or bioabsorbent applied to a coating refers to a coating in which the molecular weight and solubility characteristics are absorbed from the surface of the sewing thread and removed in unchanged or hydrolyzed form by hydrolysis or enzymatic degradation or because of its inherent properties. .

Lubricatable sheaths not only facilitate the downward movement of the knot, but also increase the lubricity and flexibility of the stitches, making the stitches easier to pass through the skin and other tissues. This reduction in friction is called a decrease in resistance to tissue. A sheath that reduces tissue resistance and smoothes knot movement also causes the knot to slip easily.

Another unexpected advantage of the lubricity coating of the present invention is that the knot is improved as the wound heals because the lubricity copolymer is absorbed within days of sewing.

The absorbent coating is one or more of the group of compounds whose structure consists of polyoxyethylene blocks, polyoxypropylene blocks, and the like. For convenience of explanation, these compounds will be treated as if two or three blocks are chained. However, it should be understood that small amounts of polyoxypropylene may be present in the polyoxyethylene block, and that small amounts of polyoxyethylene may also be present in the polyoxypropylene block. From the method of preparation it will appear that such small amounts of mixture are present in chains.

The lubricant of the present invention has the following structural formula.

Wherein one of R ₁ and R ₂ is methyl and the other is hydrogen, n and m are sufficiently large that at 25 ° C. the compound is kneaded to solid, and R is a reactive hydrogen compound having a relatively low molecular weight of 2 to 6 reactions. Having hydrogen atoms and no more than six carbon atoms, C is the number of reactive hydrogens in the compound forming R. Preferred compounds at least kneaded at 25 ° C. are those compounds that adhere better to the synthetic absorbent multithread thread. There is no clear limit, but in general, the more kneaded or solid the material, the more effective it is.

These lubricity bioabsorbable copolymers are classified as surfactants because polyoxyethylene blocks are predominantly hydrophilic and polyoxypropylene blocks are predominantly hydrophobic. This material is marketed under the trademark PLURONICS and has the following structural formula:

Where x, y and z are total numbers.

REVERSE PLURONICS has the following structural formula:

Where n, m and o are the total number.

Tetronics has the following structural formula:

이고 q 및 r은 전체 수이다.Where R ₁ is

And q and r are total numbers.

Synthetic absorbent sewing lubricants suitable for the purposes of the present invention are such that the values of x, y, z, n, m, o, q and r cause the lubricant to be kneaded or solid at 25 ° C.

The kneading state is an opaque semisolid, which has a melting point of at least room temperature, preferably at least about 40 ° C.

Those classified as pluronix are particularly useful in the present invention.

The compositions of some commercially available products are shown in Table I as a rough indication.

All compositions are mixtures, so all values are approximate and slightly rounded off.

TABLE 1

Pluronix, generally having a molecular weight range of about 4750-16250, is a waxy solid. The molecular weight of the polyoxypropylene moiety is 950-4000 and the content of polyoxyethylene is about 60-80%.

Generally, the total molecular weight range of the kneaded state is 3500 to 5700, the polyoxypropylene molecular weight range is 1750 to 6500 and the polyoxyethylene content is 30 to 50%. There is no clear limit from the wax to the kneading process.

The low toxicity of the polyoxyethylene-polyoxypropylene compounds of the present invention is shown in the following table.

TABLE 2

When making absorbent surgical stitches, the string to be sewn is used as the basis of weight in determining the amount of material placed on the synthetic absorbent polymer string.

The amount of lubricious bioabsorbable copolymer is about 0.1 to 25% by weight of the uncoated twisted line, based on the weight of the uncoated twisted line making the stitch. Even if the surface is discontinuously coated, the coating does not necessarily have to be continuous because it reduces the locking friction. If the lubricious bioabsorbable copolymer penetrates into the twist line, larger amounts can be used to partially or wholly cover the various threads.

Because of the wide range of coating weights, the sewing of the present invention can be used in various other applications. Twisting lines to sew not only have different mechanical structures, such as how to twist them, but also make filaments of more than 6 denier from less than 2 denier per thread, and the smaller the thread, the smoother the surface. The roughness of the surface may vary considerably. The degree of surface removal may also vary because the thread is extended or heat treated after the sewing thread is made. The smoother the surface, the less lubricious bioabsorbable copolymer can be used to achieve comparable lubrication.

The various surgical techniques used are correlated with the desired degree of lubrication. For certain types of knots, the use of more lubricants in certain techniques increases the ease of downward movement, while also increasing the ease of slipping the knot, called knot safety. For some surgical methods it is highly desirable that the knot move down very freely, even if the knot slides back more easily.

The knotting physician is faced with the interaction between the knotting method and the ease of slipping. If the sewing thread is relatively well coated, the doctor can use a angular knot that moves easily down, while creating a separate angular strand to ensure the knot's safety. Conversely, if there is less lubricant on the sewing thread, the doctor may use a double half-joint or other form of knot to make the knot easier to move down and pull the double half-line after it is in place to make it a angular knot. Or you can make a separate strand on the knot to ensure the safety of the knot. In this way, the doctor can adapt his knot technique to a particular sewing thread, or adapt the lubricity of the sewing thread to the knot technique he wishes to use. In general, they are adapted to each other. The doctor tries to find a sewing thread with the characteristics he likes, and then adapts his knotting technique to his sewing thread. Some doctors have successfully made knots with stainless steel strings using knot technology, which is extremely poor in mobility. Others prefer to sew well-lubricated stitches with much better downward mobility. Since the downward mobility of the knot and the safety of the knot are slightly opposite properties, the surgeon must use separate strands or knots that endure under certain conditions of the surgical procedure. By varying the amount of lubricious bioabsorbable copolymer, downward mobility can be tailored to the physician's preference.

The duration of the knot can vary considerably.

Since the lubricious bioabsorbable copolymer of the present invention is removed from the sewing in the living tissue, the safety of the knot is significantly improved if the lubricant is removed after about 48 hours.

The need for surgery varies widely, so changing the dosage can be adapted to different conditions. In general, if the surgeon wants to sew well lubricated, use a larger amount of lubricious bioabsorbable copolymer; on the contrary, if the surgeon wants the knot to have a slightly lower downward mobility and tissue suppression property to increase the safety of the knot, What is necessary is to reduce a coating amount.

Using a lubricity bioabsorbable copolymer, usually 2% -8%, provides a useful balance between ease of knot downward movement and knot safety.

For braided strings made of polyglycolic acid and 2-6 denier per thread, using about 5% by weight of Pluronic F-68 provides a good balance between knot downward movement and knot safety. .

The following examples show the effect of type and amount of coating under a given situation.

Example 1

Downward movement and jam friction test

A set of 2/0 USP XIX (diameter 0.339 mm, maximum) polyglycolic acid sewn from twisted extrudate, 2 denier per filament, covered with 7 levels of Pluronic F-68 and uncoated The angular knot was tested for downward movement.

In this test, a woven knot was sewn around a 4 inch cylinder. The loop formed in this way was removed from the cylinder and placed in the tester jaw. Pulling the free end of the knot in the tester allowed the knot to move down, where the tester recorded traction on the chart as the knot descended along the stitch. As the knot was moved downward, there was a change in the frictional friction, i.e. the downward tension of the knot. I drew this on the graph. After one set of tests with varying degrees of coverage, the percentage of the maximum force of downward movement of the knot was indicated in the individual ranges given in the table. In the case of a covered stitch, all knots were moved down along the entire length of the stitch without being destroyed. The knot breaking force of the string to be sewed was in the range of 7-8 pounds. In the case of uncoated braids, the knot did not move and was sewn 9 times in 10 tests.

TABLE 3

For this coating, the twist line was passed through a Pluronic F-68 solution having a concentration about 2 times greater than the percent coating of the sewing thread in chloroform.

For other twisted line structures and sizes, the relative ease of downward movement of the knot may be greater or angled for the same amount of sheath, or conversely, the desired amount of knot downward movement may be obtained by adjusting the sheath.

The amount of Pluronic in the solvent can be changed and a solvent other than chloroform can also be used.

Other organic solvents such as methyl alcohol, ethyl alcohol, isopropyl alcohol, methylene chloride, hot xylene (about 60 ° C), tetrahydrofuran, acetone, dimethylformamide, dimethyl sulfoxide, mixtures of these or other similar lubricants Can be used for coating. It is another useful coating technique to pass the solution through the moving string and dropping excess liquid.

A small amount of water increases the solubility of the lubricant and also aids in the coating, but the sewing thread should be dried quickly if there is moisture in the coating system, since the time for sewing to come into contact with water is minimal.

In general, it is convenient to use a solvent coating device at a sampling level of less than 10% and a heating die at a sampling rate of 10% or more.

Example 2

A series of tests were carried out using a 2/0 size sewing thread made of absorbent polyglycolic acid braided with 6-denier per filament coated with two types of Pluronix F-68 and F-127. Coating was carried out with a pluronic solution in chloroform. Pluronic concentration in the solution used for the coating was about twice that obtained from the twist line. The solution containing about 2.8% of Pluronic F-68 in chloroform left about 1.4% of Pluronic F-68 in the twist line. By adjusting the concentration, any desired coating level can be obtained. The strands to be coated were twisted with a 2/0 size sewing thread using 6 denier polyglycolic acid extrudate per thread. Uncoated seams of the same size were used for comparison. Using the two-way amplifier recorder, the tensile force of the twist line fed to the tester and the test line was recorded. The frictional interest is the ratio of the maximum tensile force (T ₃ ) to the supply tensile force (T ₂ ) minus the ratio of the minimum tensile force (T ₁ ) to the supply tensile force, ie, T ₃ / T ₁ -T ₂ / T ₁ .

The value of the frictional force is T ₂ when it starts to slide.

Of particular interest are ratios and percent reductions. With other test instruments, the figures may change, but the relative ratios as indicators of improvement are similar.

Untested twisted lines coated as indicated were used in this test. To sew, the strings are cut to length, stitched, packed and sterilized. The locking friction is better measured in the untwisted continuous twist line.

Static friction, friction and reduced friction coefficients are shown in Table IV for sewing at normal cover levels.

TABLE 4

Testing the safety of knots depends on the knotting technique.

A series of tests were conducted on the safety of the knots by coating them with 4.79% Pluronic F-68 on polyglycolic acid stitching, 2 denier per thread, and making other knots. The force in pounds for the knot to slip or break without slipping is shown below:

Example 3

A series of tests were carried out by the method of Example 2 with no coating and with a fluoroform bioabsorbable lubricity copolymer solution. Table V shows the improvement in jam friction obtained with a series of polymers and concentrations.

TABLE 5

Example 4

Polyglycolic acid strands of size to form 2/0 USP stitches were soaked in 10% Pluronic F-68 solution in chloroform and dried. The yield was about 5% by weight of the twist line.

The dried coated string was delivered 54 inches long to sew, packaged, sterilized and dried.

This stitch was used for surgical operations. When used on injured tissue, the stitches were put in place and tied in a angular knot. The angular knot moved down easily and pulled the edge of the wound as tight as the doctor wanted. The stitching had a low resistance to the tissue and the knot downward mobility was excellent. When the knot came to the desired final position, three separate angular strands were made to make the knot safe. The knots contained within the tissue had a lubricity bioabsorbable copolymer, which was removed from the surface to be sewn within 48 hours, making the knot more secure. The stitches themselves had tissue support for at least 15 days and were significantly absorbed after 90 days.

Although angular knots have been tested as examples, ease of knot downwards and reduced tissue resistance are useful for most sewing and knot support. The relative value of the amount of coating, and thus the downward movement of the knot and the reduction of tissue resistance, can be altered to suit specific surgical conditions.

Sewing, packaging and sterilizing needles on the coated sewing thread is carried out in a conventional manner.

Example 5

Friction and Jam Test

A set of 2/0 USP XIX (0.339 mm diameter, maximum) twisted silk stitches were covered with 5 levels of Pluronic F-68 and 12 levels of Pluronic F-127.

Four uncoated braids of the same size were tested and their averages used as comparisons.

Five tests with commercially available silicone-coated silk stitches were used as comparisons.

To coat them, the plutonic solution in chloroform was sewn to a concentration twice that of the desired percentage for the coating to pass through the twist line and air dried.

Using a two-way amplification recorder, the tensile force of the twist line fed to the tester and the test line exiting the tester was recorded. The friction factor is the ratio of the maximum tensile force (T ₃ ) to the supply tensile force (T ₁ ) minus the ratio of the minimum tensile force (T ₂ ) to the supply tensile force, ie, T ₃ / T ₁ -T ₂ / T ₁ . The value of the friction force is T ₂ / T ₁ when it starts to slide.

Of particular interest are ratios and percentage reductions. Using other types of test equipment, the figures may change, but the relative ratios as eye indicators are comparable.

In this test, uncut cords coated as indicated were used. To sew, these twisted strings are cut to length, stitched and packed and sterilized. Friction and grip are better measured with continuous twisted lines that are not cut.

Static friction, friction and reduction of friction coefficients are shown in Table VI.

TABLE 6

In the case of twisted strings of other structures and sizes, the relative ease of downward knot movement for the same amount of sheath may be greater or smaller, or, conversely, by adjusting the amount of sheath, the desired knot downward movement can be obtained. .

The amount of plutonic in the solvent can be varied and other solvents other than chloroform may be used.

For other organic solvents, such as methyl alcohol, ethyl alcohol, isopropyl alcohol, methylene chloride, hot xylene (about 60 ° C.), tetrahydrofuran, acetone, dimethylformamide, dimethyl sulfoxide, mixtures thereof, or other lubricants A solvent can also be used for a coating | cover. Flowing the solution through a moving twisting line and draining out excess liquid is another useful coating technique.

Small amounts of water increase the solubility of the lubricant and help the coating.

In general, it is convenient to use less than 10% of the collection in a solvent coating apparatus and more than 10% of the collection in a heating die.

Example 6

2/0 Nylon Twist

The method of Example 1 was tested using a nylon twist to make a 2/0 size sewing thread. Reduction of friction and locking factors is shown in Table V. Uncoated braids of the same size and commercially available silicone coated nylon were used for comparison.

In particular, the reduction of jams is remarkable.

TABLE 7

Example 7

2/0 Dacron Twist

It was tested by the method of Example 1 with a polyester twist (darkon) to make a 2/0 size sewing thread. Reduction of friction and locking factors is shown in Table V.

Uncoated twist lines of equal size and silicone coated twist lines were used for comparison. The degree of improvement was indicated using the average of the test results for uncoated twisted lines.

TABLE 8

The materials in the examples are for illustration. Reduced friction and improved grip result in sewing of any size. Different materials and structures can result in different results.

The amount of coating and the ease of downward movement can be varied to obtain the results desired by the physician.

In the case of stitching where capillary is a problem, whether absorbent or non-absorbent, phosphatide, more preferably a purified lecithin coating, can be used to reduce capillary and friction, wherein the coating of the present invention further reduces friction Role. Lecithin sometimes causes tissue pain, especially when it is not pure.

Example 8

Silk tufts of size to make 2/0 USP stitches were soaked in a 10% Pluronic F-68 solution in chloroform and dried. The harvest was about 5% by weight of the twisted string itself.

The dried coated string was cut to 54 inches long and stitched into needles for packaging, sterilization and drying.

The silk stitches thus made were used for surgical operations. When used on wounded tissue, the stitches are placed in place and tied in a angular knot. The angular knot was easily moved down and pulled the edge of the wound as tight as the doctor wanted. This stitching had a low tissue resistance and a good knot downward movement. When the knot came to the desired final position, three angular strands were made separately to make the knot safe. The knot in the tissue had a lubricious bioabsorbable copolymer, which was removed from the surface of the stitch within 48 hours to make the knot safer.

When removed from the test animals after 48 hours, the safety of the angular knot increased significantly without making a separate strand.

In human tissues, as can be observed, the safety of the knot increased as the bioabsorbable sheath was absorbed into the tissue.

Although angular knots have been tested as examples, ease of knot downward movement and reduced tissue resistance are useful for most sewing and knot support. The amount of sheath, and therefore the relative value of the knot downward movement and the reduction in tissue resistance, can be altered to suit the particular surgical situation.

Needle cutting, packaging and sterilization should be done in the usual way.

Claims (1)

It is made of multi-threaded polymer twisted string, and is thinly coated with a lubricity absorbent copolymer including polyoxyethylene block, polyoxypropylene block, etc., and the absorbent copolymer has a molecular weight of 25 ° C. in a kneaded to solid state. Surgical sewing characterized in that it has an improved knot downward movement and reduced tissue resistance.