ANTIMICROBIAL AND HEMOSTATIC SUTURE

Technical Field

The invention includes the spinning of commercially available hemostatic and antimicrobial preparations with biocompatible polymers. In this context, as an example, PVA-Chitosan antibacterial and hemostatic suture and I or textile constructions obtained from the said suture will be described with superficial application and I or use in the surgical field. Approved herbal hemostatic agents with hemostatic and antimicrobial activity can be used in preparations for this purpose in the production of this product.

Known State of the Art

Loss of 20 % or more of the total body blood volume is defined as severe blood loss. Hemostasis refers to the process of clot formation and stopping bleeding as a result of the relationship between platelets and clotting factors. In general, auxiliary devices and drugs used in trauma, dental operations, spontaneous or surgical procedures are called hemostatic agents. Hemostatic agents (bleeding stopping agents) show their effects through different mechanisms. Systemic agents trigger primary hemostasis, promote fibrin formation or coagulation, inhibit fibrinolysis, while local hemostatic agents cause vasoconstriction or induce platelet aggregation.

Surgical sutures have a thriving market among other materials used in medicine as wound closure elements. Other wound closure materials such as staples and tapes, which have been offered as alternatives to surgical sutures for wound repair, have not been as widely used as surgical sutures. In current surgical sutures, it is very important that biocompatibility and antimicrobial properties can be combined and most importantly, strength can be ensured during application. In standard procedures, different natural or synthetic polymers are used.

Non-absorbable surgical sutures have played an important role in the development of surgical procedures. These are surgical sutures that can maintain their strength for more than 60 days and are defined as filamentous material based on the degradation mechanisms of living tissue. In living tissue, they effectively resist digestion by enzymes. Non-absorbable surgical sutures remain in the body with little loss of physical properties without loss of mass. However, certain types degrade in the body over a long period of time. The material is encapsulated or surrounded rather than digested. The healing tissue grows around the surgical suture. When embedded in tissue in this way, they usually stay in place. When used for skin closure, they should be removed after healing has taken place.

Non-absorbable surgical sutures are divided into 3 classes by the USP.

1- Silk and monofilament or multifilament synthetic sutures.

2- Cotton, linen and coated natural or synthetic sutures.

3- Monofilament or multifilament steel wire sutures.

The reason for non-absorbable surgical sutures are divided into classes is due to differences in their tensile strength. Class 1 is stronger than class 2. Class 3 is the strongest. The most common non-absorbable surgical sutures today are silk, polyamide, polypropylene, polyester and metal suture.

Absorbable surgical sutures are surgical sutures that lose their tensile strength within 60 days and are destroyed by degradation. Absorbable surgical sutures are digested by the release of proteolytic tissue enzymes, which are complex substances found in polymorphonuclear leukocytes surrounding the catgut, or hydrolyzed by tissue fluids secreted from the lung or kidney, as in the case of synthetics. Compared to enzymatic action, hydralization causes less tissue reaction. There are two properties that determine the behavior of absorbable surgical sutures in living tissue; the first is the rate of melting and mass loss and the second is the retention of tensile strength. The fact that absorbable surgical sutures lose their tensile strength does not mean that they are completely absorbed. Because, all absorbable surgical sutures remain in the tissue for some time after losing their strength. Although the rate of absorption is important for various suture complications, the rate of tensile strength loss is important as a guarantee of maintaining tissue approximation during healing. Therefore, although the rate of absorption of an absorbing surgical suture material is important for various surgical suture complications, the rate of tensile strength loss is important as a guarantee to maintain tissue approximation during healing. This makes it necessary to distinguish between the rate or time of absorption of an absorbable surgical suture material and the rate or time of tensile strength loss. The most commonly used absorbable surgical sutures today are catgut, polyglycolic acid, polyglactin, polydioxanone, polymethylene carbonate and polyglecapron 25.

One of the documents in the state of the art is patent application EP1375706B1. Disclosed herein is a method for forming a bioabsorbable, high tenacity surgical suture fiber, and a surgical suture fiber produced by this method. The suture described herein is a PGA/PLA copolymer surgical suture fiber with a fiber strength in the range of about 7.2 to 8.0 grams/ denier and a fiber elongation of about 22 % to 35 %.

However, products in the state of the art are insufficient for these needs. Therefore, it is necessary to make a development in the relevant field in order to prevent and eliminate the problems related to the subject.

Object of the Invention

The present invention relates to an antimicrobial and hemostatic suture which meets the above mentioned requirements, eliminates all disadvantages and brings some additional advantages.

The primary object of the present invention is to provide a technique of processing commercially available hemostatic and antimicrobial preparations into sutures with biocompatible polymers and to use the PVA-Chitosan antimicrobial and hemostatic sutures and I or textile constructions obtained from the said sutures in the superficial application and I or surgical field.

The hemostatic suture developed to fulfill the above-mentioned objectives comprises a combination of chitosan as an antimicrobial and hemostatic agent with a biocompatible polymer.

The structural and characteristic features and all advantages of the invention will be more clearly understood from the detailed description and figures below, and therefore the evaluation should be made by taking these detailed descriptions and figures into consideration.

Description of the figures

Figure 1- Perspective and cross-sectional view of the suture

Figure 2- Electron microscope view of the developed suture

Detailed Description of the Invention

In this detailed description, the invention is described only for a better understanding of the subject matter and without any limiting effect.

In its most basic form, the inventive antimicrobial and hemostatic suture comprises a combination of chitosan as an antimicrobial and hemostatic agent with a biocompatible polymer. The suture preferably comprises herbal hemostatic agents.

In a preferred embodiment of the invention, the biocompatible polymer is for example PVA, TPU or PP. The inventive hemostatic suture is used in the superficial application of textile constructions and I or in the surgical field. Said textile construction may be knitted, woven or electrospinning. The perspective and cross-sectional view of the developed suture is given in Figure 1.

The antimicrobial and hemostatic suture developed in an embodiment of the invention is obtained with the following process steps; a solution of biocompatible polymer (preferably selected from the group containing PVA, TPU, PP) and chitosan, a hemostatic agent, is prepared, preferably in a total proportion of 2 % to 80 %,

The prepared solution is preferably passed through a coagulation bath containing acetone and Na2SO4/(NH4)2SO4, preferably leaving the spinneret running at a pump speed of 5-10 rpm;

It is drawn through godets with a total draft ratio of preferably 1 .2-3.5, dried and wound on a bobbin. The most important point to be considered in the developed method is that the suture produced is obtained by using the combination of PVA and chitosan. In other words, a produced suture is not obtained by method steps such as dipping in and out of PVA and I or chitosan solution, but directly contains this combination. This increases the effectiveness of the product.

In a preferred embodiment of the invention, the biocompatible polymer (PVA)-chitosan containing solution is prepared as follows; PVA granules are made into a solution in a solvent (preferably DMSO) for 3-4 hours at a temperature of 70-80 'C. Preferably, a minimum of 0.01 % chitosan by weight is added to the prepared solution and preferably at 70-80 D for 3-4 hours with the help of a mixer and the solution containing PVA-DMSO- Chitosan is obtained.

The chitosan mentioned here can be of any molecular weight and can be obtained from any source. The said chitosan is preferably derived from the exoskeleton of fungi, molds or arthropods. Chitosan is a crystalline microfibril synthesized by numerous living organisms, forming structural components in the exoskeleton of arthropods and in the cell walls of fungi and yeasts. Both coagulation and agglutination tests show that the hemostatic mechanism of chitosan is independent of the classical coagulation cascade and is a direct interaction between the erythrocyte cell membrane and chitosan. The electron microscope view of the developed suture is given in Figure 2.

In the developed invention, when the biocompatible structure of PVA and the antimicrobial and hemostatic effect of chitosan come together, the microbiological quality of the infection that may occur especially in the suture area is ensured and the occurrence of infection in the said area is limited. With the invention, the healing process of the wound is faster as the microbiological quality is assured during the healing process. Similarly, effective results are obtained in micro and I or post-operative bleeding that cannot be solved as desired in the state of the art with its bleeding stopping effect and related operative cauterization. The suture obtained can be made into textile construction by itself and I or with additional functional substances (natural, organic, inorganic synthesis product or a single element).