Biodegradable and biocompatible suture and method for preparing the same

A biodegradable suture using poly(3-hydroxypropionate) with controlled manufacturing parameters maintains strength and biocompatibility, addressing strength loss and inflammatory issues in existing sutures.

WO2025264635A1PCT designated stage Publication Date: 2025-12-26NOROO IC CO LTD
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Patent Information

Application Number
PCT/US2025/033919
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-06-18
Filing Date
2025-06-17
Publication Date
2025-12-26

AI Technical Summary

Technical Problem

Existing biodegradable sutures lose strength over time in vivo and do not provide sufficient strength retention, antibacterial properties, and biocompatibility, leading to potential inflammatory reactions.

Method used

A biodegradable suture made from poly(3-hydroxypropionate) (P(3-HP) with controlled molecular weight and hot drawing process parameters to maintain strength and biocompatibility, featuring antibacterial properties and low biotoxicity.

Benefits of technology

The suture maintains 40-95% of its initial tensile strength for 2-4 weeks and 20-80% for 8 weeks in vivo, with no inflammatory reaction and biodegrades naturally, ensuring effective suturing and lifting effects.

✦ Generated by Eureka AI based on patent content.

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Abstract

A biodegradable and biocompatible suture includes poly(3-hydroxypropionate). The biodegradable and biocompatible suture is prepared by a hot drawing method using poly(3-hydroxypropionate) and under process conditions where melt extrusion temperature, elongation rate and drawing temperature are adjusted. The biodegradable and biocompatible suture maintains a predetermined strength in vivo, can be naturally biodegraded in vivo after a certain period of time, and exhibits antibacterial properties and low biotoxicity without causing an inflammatory reaction in vivo.
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Description

[0001] BIODEGRADABLE AND BIOCOMPATIBLE SUTURE AND METHOD FOR

[0002] PREPARING THE SAME

[0003] BACKGROUND

[0004] 1. Technical Field

[0005]

[0001] The present invention relates to a biodegradable and biocompatible suture and a method for preparing the same, and more specifically, to a suture prepared by a hot drawing method using poly(3-hydroxypropionate) as a biodegradable resin and under process conditions where melt extrusion temperature, elongation rate and drawing temperature are adjusted, and a method for preparing the same. The suture according to the present invention may maintain a predetermined strength in vivo, can be naturally biodegraded in vivo after a certain period of time, and exhibits antibacterial properties and low biotoxicity without causing an inflammatory reaction in vivo.

[0006] 2. Background Art

[0007]

[0002] Sutures are threads that are mainly used in surgical operations to stitch damaged tissues due to trauma or to re-stitch incised skin. Depending on the diameter of the suture, sutures are used for various applications such as human tissue lifting or filler applications for skin volume, in addition to typical surgical purposes.

[0008]

[0003] Conventional non-biodegradable sutures required removal after a certain period of time had elapsed following surgery. To resolve this inconvenience, biodegradable sutures that do not need to be removed even after a certain period of time has elapsed are being researched and developed.

[0009]

[0004] Biodegradable sutures are threads that naturally biodegrade in vivo or in the skin itself after a certain period of time has elapsed, and are particularly suitable for use in fixing skin or suturing soft tissue.

[0010]

[0005] Several technologies related to such biodegradable sutures have been developed in the art. Among them, Patent Document 1 discloses a biodegradable surgical suture composed of a core portion made of a biodegradable monofilament and a sheath portion made of a biodegradable multi-filament that is installed and encloses an outer surface of the core portion in order to solve the problems associated with the non-uniform diameter of the biodegradable monofilament suture and to improve knot stability. Here, the biodegradable monofilament and the biodegradable multi -filament are composed of a homopolymer or copolymer of polyglycolic acid, polyglycolic-co-L-lactide, poly-p- dioxanone, polyglycolic-co-8-caprolactone, poly(e-caprolactone), and polytrimethylene carbonate.

[0011]

[0006] In addition, Patent Document 2 discloses a biodegradable suture including heterologous first and second components in order to control the biodegradation rate of the suture so as to maintain a predetermined strength or higher, and further discloses that the first and second components each include polycaprolactone, poly-L-lactic acid, polydioxanone, or polyglycolic acid.

[0012]

[0007] In addition, Patent Document 3 discloses a high-functional suture prepared using a lactide polymer and a caprolactone polymer to secure the processability (injectability and flexibility) of the suture and to improve fixation and tensile strength within the tissue.

[0013]

[0008] Meanwhile, Patent Document 4 discloses a method for preparing a suture including a polycaprolactone-paradioxanone block copolymer that enables continuous production and mass production, and suggests that a first drawing step is performed at a high temperature in the range of 110 to 120°C and a second drawing step is performed at a high temperature in the range of 115 to 125°C in the suture manufacturing process.

[0014]

[0009] However, these patent documents and other prior art do not disclose a suture that may maintain sufficient strength even after a certain period of time has elapsed while resolving the problem of biodegradable sutures losing strength over time in vivo without using a combination of heterologous biodegradable resins, and furthermore, do not provide any data on the change in strength of the suture over time.

[0015]

[0010] Therefore, there is a demand for the development of a suture that can be biodegraded in vivo after a certain period of time has elapsed, exhibits antibacterial properties and low biotoxicity without causing an inflammatory reaction in vivo, and has improved biodegradability and biocompatibility, so that it may maintain a predetermined strength for a certain period of time after in vivo application.

[0016] [Prior Art Document]

[0017] [Patent Document]

[0018]

[0011] (Patent Document 0001) [Patent Document 1] Korean Patent Laid-Open

[0019] Publication No. 10-2011-0088999

[0020] (Patent Document 0002) [Patent Document 2] Korean Patent Laid-Open

[0021] Publication No. 10-2021-0092015

[0022] (Patent Document 0003) [Patent Document 3] Korean Patent Laid-Open

[0023] Publication No. 10-2506968

[0024] (Patent Document 0004) [Patent Document 4] Korean Patent Laid-Open

[0025] Publication No. 10-2102342

[0026] SUMMARY

[0027]

[0012] It is an object of the present invention to provide a suture that can be biodegraded in vivo after a certain period of time has elapsed, exhibits antibacterial properties and low biotoxicity without causing an inflammatory reaction in vivo, and has biodegradability and biocompatibility (hereinafter, also referred to as “biodegradable / biocompatible”) while maintaining sufficient strength for a certain period of time.

[0028]

[0013] In addition, it is another obj ect of the present invention to provide a method for preparing a biodegradable / biocompatible suture according to the present invention using a hot drawing method.

[0029]

[0014] The present invention has been devised to solve the problems of the abovedescribed prior art, and according to the present invention, a biodegradable / biocompatible suture including poly(3-hydroxypropionate) (hereinafter, also referred to as “P(3-HP)”) is provided.

[0030]

[0015] In the present invention, the P(3-HP) may have a weight average molecular weight of 50,000 to 2,000,000 Daltons.

[0031]

[0016] The biodegradable / biocompatible suture of the present invention may be formed in a monofilament form, a pseudo-monofilament form, a multi-filament form, or a coreshell filament form.

[0032]

[0017] The biodegradable / biocompatible suture of the present invention may have an initial tensile strength of 100 to 800 N / mm2

[0033]

[0018] The biodegradable / biocompatible suture of the present invention may maintain a tensile strength of 40 to 95%, based on the initial tensile strength of the suture, after 2 to 4 weeks of in vivo application.

[0034]

[0019] The biodegradable / biocompatible suture of the present invention may maintain a tensile strength of 20 to 80%, based on the initial tensile strength of the suture, after 8 weeks of in vivo application.

[0035]

[0020] The present invention also provides a method for preparing a biodegradable / biocompatible suture of the present invention, and the method for preparing a biodegradable / biocompatible suture according to the present invention may include the following steps of:

[0036]

[0021] 1) melt-extruding P(3-HP);

[0037]

[0022] 2) uniformly mixing the P(3-HP) melt-extruded in step 1) and then spinning it; and

[0023] 3) hot drawing the spun product obtained in step 2) to prepare a suture in a filament form.

[0038]

[0024] The melt extrusion in step 1) may be performed at a temperature of 100 to 200°C.

[0025] In step 2) above, the spinning may be performed at a temperature of 100 to 200°C.

[0039]

[0026] In step 3) above, the hot drawing may be performed at a temperature of 30 to 100°C.

[0040]

[0027] Depending on the drawing conditions in step 3), the prepared suture may have a weight average molecular weight reduced by 50 to 96%, compared to its initial weight average molecular weight at the beginning of hot drawing, after 2 to 4 weeks of in vivo application.

[0041]

[0028] In step 3) above, the hot drawing may be performed at an elongation rate of 300 to 1200%.

[0042]

[0029] According to the present invention, there may be provided a biodegradable / biocompatible suture that can be biodegraded in vivo after a certain period of time has elapsed, exhibiting antibacterial activity' and low biotoxicity without causing an inflammatory reaction in vivo, and may maintain sufficient strength for a certain period of time.

[0043]

[0030] In addition, according to the present invention, the biodegradation rate of the suture after in vivo application may be adjusted depending on the drawing conditions in the suture manufacturing process.

[0044] BRIEF DESCRIPTION OF THE DRAWINGS

[0045]

[0031] FIG. 1 is a graph illustrating the comparison of the biodegradability' (cumulative CO2 emission) among poly(3-hydroxypropionate (P(3-HP)), polylactic acid (PLA), and microcrystalline cellulose. FIG. 2 is a view illustrating an example of a manufacturing process of a suture according to an embodiment of the present invention.

[0046] FIG. 3 is a graph illustrating the trend of changes in the weight average molecular weight (MW) by week after the sutures according to examples of the present invention and comparative examples were applied in vivo in animal experiments.

[0047] FIG. 4 is a graph illustrating the trend of changes in the tensile strength (N / mm2) by week after the sutures according to examples of the present invention and comparative examples were applied in vivo in animal experiments.

[0048] FIG. 5 is a graph illustrating the trend of changes in the elongation rate (%) by week after the sutures according to examples of the present invention and comparative examples were applied in vivo in animal experiments.

[0049] FIG. 6 is a photograph illustrating the condition of the suture according to an embodiment of the present invention, which was applied to the abdominal cavity in an animal experiment and then removed weekly.

[0050] FIG. 7 is a photograph illustrating the condition of the suture according to an embodiment of the present invention, which was applied to the subcutaneous tissue in an animal experiment and then removed weekly.

[0051] FIG. 8 is a photograph illustrating the condition of the suture according to a comparative example, which was applied subcutaneously in an animal experiment and then removed weekly.

[0052] FIGS. 9A and 9B are set of photographs demonstrating excellent biocompatibility7by illustrating a clean state without inflammation at 12 weeks after the suture according to an embodiment of the present invention was applied subcutaneously (FIG. 9A) and to the abdominal cavity (FIG. 9B).

[0032] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present disclosure pertains. Terms, such as those defined in commonly used dictionaries, are not to be construed in an idealized or overly formal sense unless expressly so defined herein.

[0053]

[0033] Hereinafter, a biodegradable / biocompatible suture according to the present invention and a method for preparing the same will be described in detail.

[0054]

[0034] The present inventors have conducted extensive research to improve the problems of conventional biodegradable / biocompatible sutures and. as a result, have discovered that poly(3-hydroxypropionate) not only has excellent biodegradability, particularly at room temperature, but also that the 3-hydroxypropionate produced by its decomposition in vivo exhibits antibacterial properties. Therefore, it is highly suitable as a material for biodegradable / biocompatible sutures that do not cause an inflammatory reaction in vivo. Furthermore, in addition to its excellent biodegradability and biocompatibility, it maintains sufficient strength even after a certain period of time has elapsed following in vivo application, such as in internal organ sutures, or skin sutures. Accordingly, the present invention has been completed on the basis of the above discoveries.

[0055]

[0035] Accordingly, the biodegradable / biocompatible suture according to the present invention is characterized by including poly(3-hydroxypropionate) (P(3-HP)).

[0056]

[0036] In general, since most of the existing biodegradable resins can be biodegraded under composting conditions, parameters such as temperature (high temperature), the carbon to nitrogen ratio, the oxygen ratio in the air, the moisture content, and pH should be adjusted to conditions suitable for composting in order to achieve biodegradability. In contrast, the P(3-HP) included in the biodegradable / biocompatible suture of the present invention has the characteristic of being biodegradable even under room temperature conditions (20±5°C), which are not composting conditions. In the experiments of the present inventors, it was proven that P(3-HP) exhibits excellent biodegradability even at room temperature, whereas polylactic acid (PLA). a representative biodegradable resin, was hardly biodegraded at room temperature (see the experimental examples described below and FIG. 1).

[0057]

[0037] According to a preferred embodiment of the present invention, the weight average molecular weight of the P(3-HP) may be in the range of 50,000 to 2,000,000 Daltons (Da), 50,000 to 1,000,000 Da, and more preferably 100,000 to 1,000,000 Da. When the molecular weight of P(3-HP) is within the above range, the biodegradability and strength retention over time may be optimally adjusted, and is therefore preferable. In addition, the suture of the present invention may have a weight average molecular weight reduced by 50 to 96%, compared to its initial weight average molecular weight at the beginning of hot drawing, after 2 to 4 weeks of in vivo application, by adjusting the biodegradation rate depending on the drawing conditions in the suture manufacturing process.

[0058]

[0038] According to a preferred embodiment of the present invention, the biodegradable / biocompatible suture of the present invention may be made of filaments having a diameter of 0.01 to 2.0 mm. The filament of the present invention may have various filament forms such as a monofilament shape, a pseudo-monofilament shape, a multi -filament shape, or a core-shell filament shape depending on the intended uses, such as for surgical operations, facial wrinkle lifting, or body wrinkle lifting. Furthermore, the diameter of the filament is not limited to the above range, and may have various diameters from 0.01 to 600 mm, for example, depending on the intended applications.

[0059]

[0039] According to a preferred embodiment of the present invention, the biodegradable / biocompatible suture of the present invention may have an initial tensile strength in the range of 100 to 800 N / mm2, preferably 200 to 800 N / mm2, and more preferably 350 to 800 N / mm2. Here, the term "initial tensile strength” refers to the tensile strength of the suture in a state prepared in a filament form, i.e. before in vivo application.

[0060]

[0040] According to a preferred embodiment of the present invention, the biodegradable / biocompatible suture of the present invention may maintain a tensile strength of 40% or more, for example, 40 to 95%, preferably 70% or more, for example, 70 to 95%, of the initial tensile strength after 2 to 4 weeks of in vivo application. In addition, the biodegradable / biocompatible suture of the present invention may maintain a tensile strength of 20% or more, for example, 20 to 80%, preferably 50% or more, for example, 50 to 80%, of the initial tensile strength after 8 weeks of in vivo application.

[0061]

[0041] In general, biodegradable / biocompatible sutures, after being inserted or applied to the body through a surgical operation or a procedure such as skin lifting, biodegrade over time, thereby reducing their strength. As a result, the effects of suturing or lifting may not be sufficiently maintained for the required period of time. However, the biodegradable / biocompatible suture according to the present invention has a strength retention rate within the above range, and thus has the advantage of being able to maintain effective strength for the required period of time to obtain the desired suturing or lifting effect according to a surgical operation or a procedure.

[0062]

[0042] The present invention also provides a method for preparing a biodegradable / biocompatible suture of the present invention, and the method for preparing a biodegradable / biocompatible suture according to the present invention may include the following steps:

[0063]

[0043] 1) melt-extruding P(3-HP);

[0064]

[0044] 2) uniformly mixing the P(3-HP) melt-extruded in step 1) and then spinning it;

[0065]

[0045] 3) hot drawing the spun product obtained in step 2) to prepare a suture in a filament form.

[0046] Hereinafter, the method for preparing a biodegradable / biocompatible suture of the present invention will be described with reference to FIG. 2, which illustrates an example of the method for preparing a biodegradable / biocompatible suture according to one specific example of the present invention.

[0066]

[0047] In step 1) above, a raw material including P(3-HP) may be fed into a hopper 1 at the upper end of a nozzle unit, melted, and extruded through a nozzle 2. In this case, the melt extrusion of P(3-HP) may be performed at a temperature of 100 to 200°C, preferably 110 to 150°C, and more preferably 120 to 140°C.

[0067]

[0048] In step 2) above, the P(3-HP) melted in step 1) and extruded through the nozzle 2 may be supplied to a spinning block, uniformly mixed in a spinning pack, and then spun to prepare a filament. In this case, the spinning may be performed at a temperature of 100 to 200°C, preferably 110 to 150°C, and more preferably 120 to 140°C.

[0068]

[0049] In step 3) above, the spun product obtained in step 2) may be hot-drawn to prepare a filament. In a preferred embodiment of the present invention, the hot drawing may be performed in a first drawing step (3-1) and a second drawing step (3-2), and may be carried out by setting the temperature of heating sections (4-1 and 4-2) to 40 to 90°C. That is, the hot drawing in step 3) may be performed at a temperature of 30 to 100°C, preferably 40 to 90°C, and more preferably 60 to 80°C. In the present invention, by hot drawing the spun P(3-HP) product within the above temperature range, a biodegradable / biocompatible suture having excellent strength retention over time after in vivo application may be prepared, compared to a case in which it is drawn at room temperature.

[0069]

[0050] According to a preferred embodiment of the present invention, in step 3) above, the spun product may be drawn at an elongation rate of 300 to 1200%, preferably 500 to 1000%. By drawing within this elongation rate range, a biodegradable / biocompatible suture having a desired diameter may be prepared. Depending on the drawing conditions in step 3), the biodegradation rate of the prepared suture may be adjusted, thereby resulting in the weight average molecular weight being reduced by 50 to 96%, compared to its initial weight average molecular weight at the beginning of hot drawing, after 2 to 4 weeks of in vivo application.

[0070]

[0052] Hereinafter, the biodegradable / biocompatible suture and the method for preparing the same according to the present invention will be described in more detail through the following experimental examples and examples. It should be understood, however, that the present invention is not limited to the embodiments described below and may be embodied in various forms, and that the following embodiments are provided merely to ensure a complete disclosure of the present invention and to fully inform a person who has ordinary' knowledge in the technical field to which the present invention belongs. The present invention is defined by the scope of the claims.

[0071]

[0054] Experimental Example

[0072]

[0055] In order to confirm the room temperature biodegradability of P(3-HP), the biodegradability of the natural biodegradable material microcrystalline cellulose, as well as polylactic acid (PLA) and P(3-HP) was tested. That is, according to the ISO 17556 test standard, 5 g of each of the three biodegradable materials was ground and mixed with soil, and while the samples were maintained at room temperature of 25°C, the cumulative CO2 emission was measured over a period of 0 to 59 days to confirm the degree of biodegradation. The results are shown in FIG. 1. As shown in FIG. 1. it can be seen that, while PLA did not biodegrade under room temperature conditions, biodegradation of P(3-HP) proceeded at a relatively fast rate from about the 11th day. The calculated biodegradability of microcrystalline cellulose was 80.54%, and the biodegradability of P(3-HP) was 52.27%. From these experimental results, it was confirmed that although P(3-HP) has lower biodegradability than natural material microcrystalline cellulose, P(3- HP) shows significantly higher room temperature biodegradability compared to PLA, a representative biodegradable resin, which did not show any room temperature biodegradability.

[0073]

[0057] Example 1

[0074]

[0058] As shown in the process exemplified in FIG. 2, P(3-HP) pellets were fed into the hopper 1, melted at 130°C, extruded through the nozzle 2, and supplied to a spinning block. The material was then uniformly mixed in a spinning pack and spun at a spinning temperature of 130°C. Subsequently, in a first drawing section 3, the roller speed was adjusted to 30 RPM, in a second drawing section 5, the roller speed was adjusted to 65 RPM, in a third drawing section 7, the roller speed was adjusted to 90 RPM, and in a fourth drawing section 9, the roller speed was adjusted to 150 RPM. The temperatures of heating sections 4, 6 and 8 between the drawing sections were each set to 60°C, so that the monofilament was finally spun by drawing at an elongation rate of 500%. Then, the spun monofilament was wound (10) to prepare a suture.

[0075]

[0060] Example 2

[0076]

[0061] In Example 2, a monofilament suture was prepared in the same manner as in Example 1, except that the drawing was performed at an elongation rate of 600% by adjusting the roller speed in the fourth drawing section 9 to 180 RPM.

[0077]

[0063] Example 3

[0078]

[0064] In Example 1, a monofilament suture was prepared in the same manner as in Example 1, except that the drawing was performed at an elongation rate of 650% by adjusting the roller speed in the fourth drawing section 9 to 195 RPM.

[0066] Example 4

[0079]

[0067] In Example 1, a monofilament suture was prepared in the same manner as in Example 1, except that the drawing was performed at an elongation rate of 700% by adjusting the roller speed in the fourth drawing section 9 to 210 RPM.

[0080]

[0069] Comparative Example 1

[0081]

[0070] P(3-HP) pellets were fed into the hopper 1, melted at 130°C, extruded through the nozzle 2, and supplied to a spinning block. The material was then uniformly mixed in a spinning pack and spun at a spinning temperature of 130°C. Subsequently, in the first drawing section 3, the roller speed was adjusted to 30 RPM, in the second drawing section 5, the roller speed was adjusted to 65 RPM, in the third drawing section 7, the roller speed was adjusted to 90 RPM, and in the fourth drawing section 9, the roller speed was adjusted to 150 RPM. The temperatures of the heating sections 4, 6 and 8 between the drawing sections were set to room temperature (25°C). so that the monofilament was finally spun by drawing at an elongation rate of 500%. Then, the spun monofilament was wound (10) to prepare a suture.

[0082]

[0072] Comparative Example 2

[0083]

[0073] In Comparative Example 1, a monofilament suture was prepared in the same manner as in Comparative Example 1, except that the drawing was performed at an elongation rate of 600% by adjusting the roller speed in the fourth drawing section 9 to 180 RPM.

[0084]

[0075] Comparative Example 3

[0085]

[0076] In Comparative Example I, a monofilament suture was prepared in the same manner as in Comparative Example 1, except that the drawing was performed at an elongation rate of 650% by adjusting the roller speed in the fourth drawing section 9 to 195 RPM.

[0086]

[0078] Comparative Example 4

[0087]

[0079] In Comparative Example 1, a monofilament suture was prepared in the same manner as in Comparative Example 1, except that the drawing was performed at an elongation rate of 700% by adjusting the roller speed in the fourth drawing section 9 to 210 RPM.

[0088]

[0081] [Measurement of physical properties]

[0089]

[0082] The tensile strength and other physical properties of the monofilament sutures prepared in Examples 1 to 4 and Comparative Examples 1 to 4 were measured using the following method.

[0090]

[0083] The prepared filament was cut to a length of 240 mm, and 20 mm at opposite ends of the filament were fixed to a universal testing machine (UTM). Then, the thicknesses of the upper, middle and lower portions of the filament were measured, and the average thickness of the specimen was determined.

[0091]

[0084] Next, the gauge length (length intended to be measured) of the filament was set to 200 mm, and the filament was stretched at a speed of 100 mm / min until the filament broke. During this process, the maximum displacement and tensile strength of the filament were measured, and the breaking elongation rate was calculated from the measurements.

[0092]

[0085] The results of the physical property measurement are shown in Table 1 below.

[0093]

[0086] [TABLE I]

[0094]

[0087] Note) 1) Sample elongation rate: The elongation rate when a filament is drawn by adjusting the RPM multiple of a resin softened at a high temperature.

[0095]

[0088] 2) Gauge length: The length intended to be measured.

[0096]

[0089] 3) Breaking elongation rate: The ratio of elongation until the prepared suture breaks when cooled and then stretched.

[0097]

[0091] As shown in Table 1 above, the sutures prepared by room-temperature drawing in the comparative examples exhibited high maximum displacement and breaking elongation rate. Therefore, when used as a suture, the knot may be too easily stretched after suturing, and the workability may be poor. In addition, their strength may be relatively low, resulting in reduced stability after suturing, making them unsuitable for use as a suture. In contrast, the sutures prepared by hot drawing according to the examples of the present invention exhibited appropriate maximum displacement and breaking elongation rate, ensuring excellent suture workability. Furthermore, they had high strength, thereby maintaining excellent stability' after suturing, and thus are very suitable for use as sutures.

[0098]

[0093] [Analysis of biodegradability and biocompatibility in vivo over time (animal experiment)]

[0094] In an animal experiment using rats, the trend of changes in the physical properties and condition of the suture over time after in vivo application was analyzed as follows.

[0099]

[0095] In the cases where the suture prepared in Example 2 was applied in vivo (abdominal cavity7and subcutaneous tissue) and where the suture prepared in Comparative Example 2 was applied in vivo (subcutaneously), the weight average molecular weight (MW), tensile strength (N / mm2), and breaking elongation rate (%) were measured after removing the sutures weekly up to the 12th week. The results are shown in Table 2 and FIGS. 3 to 5. In addition, after the in vivo application of the suture, photographs taken weekly up to the 12th week after removal are shown in FIGS. 6 to 9B.

[0100]

[0097] [TABLE 2]

[0098] As shown in Table 2 and FIGS. 3 to 8 above, it can be seen that the biodegradable / biocompatible suture according to the examples of the present invention could maintain sufficient strength for a considerable period of time after in vivo application, whereas the suture according to the comparative example showed a decrease in strength after a certain period of time had elapsed.

[0101]

[0099] In addition, as shown in FIGS. 9A and 9B, it was confirmed that the biodegradable / biocompatible suture according to the examples of the present invention did not cause any inflammatory reaction in vivo even after 12 weeks, indicating excellent biocompatibility.

Claims

WHAT IS CLAIMED IS:

1. A biodegradable and biocompatible suture comprising poly(3- hydroxypropionate).

2. The biodegradable and biocompatible suture according to claim 1, wherein the poly(3-hydroxypropionate) has a weight average molecular weight of 50.000 to 2,000,000 Daltons.

3. The biodegradable and biocompatible suture according to claim 1, wherein the biodegradable and biocompatible suture is formed in a monofilament form, a pseudomonofilament form, a multi-filament form, and / or a core-shell filament form.

4. The biodegradable and biocompatible suture according to claim 1, wherein the biodegradable and biocompatible suture has an initial tensile strength of 100 to 800 N / mm2.

5. The biodegradable and biocompatible suture according to claim 4, wherein the biodegradable and biocompatible suture maintains a tensile strength of 40 to 95%, based on the initial tensile strength of the suture, after 2 to 4 weeks of in vivo application.

6. The biodegradable and biocompatible suture according to claim 4, wherein the biodegradable and biocompatible suture maintains a tensile strength of 20 to 80%, based on the initial tensile strength of the suture, after 8 weeks of in vivo application.

7. A method for preparing a biodegradable and biocompatible suture, the method comprising: melt-extruding poly(3-hydroxypropionate); mixing the melt-extruded poly(3-hydroxypropionate) and then spinning the mixed poly(3-hydroxypropionate) to obtain a spun product; and hot-drawing the spun product to prepare the biodegradable and biocompatible suture in a filament form.

8. The method of claim 7, wherein the biodegradable and biocompatible suture has a weight average molecular weight reduced by 50 to 96%, compared to its initial weight average molecular weight at the beginning of the hot-drawing, depending on drawing conditions of the biodegradable and biocompatible suture after 2 to 4 weeks of in vivo application.

9. The method of claim 7, wherein the melt-extruding is performed at a temperature of 100 to 200°C.

10. The method of claim 7, wherein the spinning is performed at a temperature of 100 to 200°C.

11. The method of claim 7, wherein the hot-drawing is performed at a temperature of30 to 100°C.[Claim 12JThe method of claim 7. wherein the hot-drawing is performed at an elongation rate of 300 to 1200%.

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