RU90673U1 - LIGATURE LOCKING DEVICE FOR SEWING OF THE SKIN CUT AND / OR BODY TISSUE - Google Patents

Abstract

1. The ligature lock device, providing the stitch when stitching the skin incision and / or wounds of body tissue, made of materials of surgical quality, characterized in that it contains three sequentially located elements: the head end with the lock of the ligature body, the ligature body and its tail end where! the head end starts the ligature lock device and is made in the form of a thickening on it, has external atraumatically rounded surfaces and edges, while it contains a through channel with a lock inside, and the channel is designed so that the lock does not interfere with the reception and subsequent advancement of the tail end and body ligatures inside the channel, up to fixing the ligature body section with a lock, in the required position, permanently or permanently - for the desired period; ! the ligature body is a direct continuation of the cephalic end, made in the form of a segment of a vein and has a surface that allows the ligature body to pass through the body tissue and the canal of the cephalic end; ! the tail end is pointed and ends the ligature body, which ensures the desired passage of the tail end and the ligature body through stitched tissues and the channel at the head end. ! 2. The ligature lock device according to claim 1, characterized in that the ligature body has a non-circular section and pronounced surfaces: dorsal and ventral, with rounding at the ends, allowing the ligature body to pass through the body tissue and the through channel of the head end. ! 3. The ligature lock device according to claim 1, characterized in that the ligature body has a circular cross-section, allowing the ligature body to pass through the body tissue

Description

The claimed technical solution relates to medical materials, specifically to suture materials, the use of which provides a knotless stitching of the skin incision and / or wounds of body tissue, providing reliability and tensile strength, resistance to infection, good handling properties, ease of sterilization, low price in mass production.

At the time of writing this application, the authors are aware of at least 250 items of suture material - hereinafter referred to as CMM, of various firms and companies, which indicates a reasonable dissatisfaction of practitioners with the quality of CMM and the ongoing search for better solutions.

Surgical wounds and occasional damage to the skin of the body are usually covered with a piece of thread inserted into the tissue with a sharp metal needle attached to one end of the thread. Such a thread in surgery is called “suture material”, or “ligature”, from the Latin ligature - “connection”.

From the source [14], continuous CMM is known, having “teeth”, which has first and second distal ends. Moreover, the direction of the teeth along the different ends of the "vein" proposed by the authors of CM is oriented in such a way that they prevent reverse bias, or otherwise, retraction of the CM in stitched tissues. However, despite the fact that the above products have relatively high strength and reduce the time of surgical intervention, their use often does not allow the surgeon to manipulate the wound edges with the plasticity of the defect with the accuracy that is provided by the use of traditional suture material, hereinafter referred to as TSW. In addition, almost all known alternatives to TSHM are cumbersome, and do not allow precise control of the tension obtained by tying a segment of suture material into the knot, and cause excessive pain when removed. When choosing analogues among medical devices, there was no one that would be suitable for solving the task - it would allow soft tissues to pass through the thickness, and then connect the ends of the ligature without tying a knot. Therefore, devices from another field of technology that have more common structural features with the claimed object are selected for the closest analogue, namely, these devices have elements that form a loop connection without tying a knot. Ties for cables and wires were chosen as analogues - the well-known patented products of Thomas & Betts [3] - [12]. These devices have a fairly rigid structure, but at the same time, they can be made quite plastic. These devices contain three main, sequentially located elements: the head end with the clamp "belt-shaped" body, the actual "belt-shaped" body and the tail end.

The disadvantage of these technical solutions is that the devices that implement them are not intended for use in performing surgical operations — they do not have an element for connecting to a surgical needle and a device for piercing body tissue. Products manufactured according to the above-mentioned inventions have a technical purpose and do not have surgical properties.

BACKGROUND OF THE INVENTION

Surgical wounds and accidental damage to the skin and / or other bodily tissue are usually closed by the approach and retention of the opposite edges of the defect using a piece of sterile thread held in the thickness of stitched tissues with a metal needle. Such a thread in surgery is called suture material. CMM is used to create “stitches” that allow you to close the wound, which is necessary to hold the tissues together until healing.

Usually, a surgical needle should penetrate into the tissue and pass through it, producing a CMM through the edges of stitched tissues in the projection of the defect of the latter. Opposite sides of the respective edges and layers of the wound bring together. A surgical needle with a thread is removed, after which the ends of the latter must be pulled and tied into a knot. As a result, CMM forms a loop in the thickness of soft tissues. When the knot is tied, the loop of the CMM with its plane, most often, is oriented transversely to the largest linear size of the sutured wound.

The knot tying procedure allows you to adjust the thread tension in accordance with the properties of the stitched fabric and control the occlusion and other characteristics of the surgical suture. The ability to control tension is an extremely important characteristic, regardless of the type of surgery performed by the surgeon.

Suturing, otherwise stitching of body tissues, is the most routine and longest part of most surgical procedures, especially in micro- and minimally invasive surgery, when there are technical difficulties in manipulating the surgical needle and stitched tissues. For proper closure of some injuries, CMM must have high strength, and therefore a relatively large diameter, resulting in reduced blood flow in stitched tissues, which can lead to iatrogenic ischemia and subsequent necrosis of the wound edges, which, in turn, does not contribute to the healing of the defect and increases the risk of infection. Moreover, the stitched fabric is often deformed by the CM loop due to excessive tension in the nodes, and the additional volume of the latter is often a significant obstacle to the normal healing of wounds of any nature.

Numerous alternatives to traditional threads are known - these are actively implantable medical devices such as brackets, clips, clips, clips, etc. [18, 21, 26, 38, 44]. These devices are usually installed across the largest size of the wound defect for connection and exposure in the opposite direction of its respective surfaces.

However, despite the fact that the above products have a relatively high strength and reduce the time of surgical intervention, their use often does not allow the surgeon to manipulate the edges of the wound with the accuracy provided by the use of TSM. In addition, almost all known alternatives to TSHM are cumbersome and do not allow you to adjust the tension obtained by tying a piece of surgical thread into a knot, and cause excessive pain when removed.

There are other no-knot technologies that offer the use of all kinds of adhesive tapes and adhesives to cover wound skin defects, but these materials have relatively low tensile strength, which in practice limits their scope, for example, the treatment of microdamages [48]. Other technologies, as a rule, include electrical coagulation and / or the use of laser radiation energy [55]. In other words, in these cases, it is proposed to use electrothermal or beam “welding” of the edges of the wound defect, which is certainly associated with the application of additional trauma to the bodily tissue in the area of its existing mechanical damage (accidental or surgical nature) and does not contribute to the normal course of the wound process [37] .

Based on the foregoing, it can be argued that the urgency of creating a device for knotless stitching of a skin incision and / or wound of body tissue exists at the present time. In the ideal case, the use of this device will allow the surgeon to efficiently, quickly, accurately and reliably bring together and hold in the required position until the edges of bodily tissue defects that have both surgical and random nature heal.

The technical results obtained when using the inventive device ligature lock (hereinafter referred to as UZL) for stitching a skin incision and / or wounds of body tissue are that:

1) when connecting the parts of the ultrasonic wave, a loop is formed from the core having an atraumatic surface, which, depending on the embodiment, can be formed in space permanently and / or permanently for the entire desired period;

2) the form of an ultrasound scan is made in such a way that it causes the least irritation in the puncture channel, because with a sufficient density of the ultrasonic material, the device is flexible, thin, and not bulky;

3) a wide range of polymers and other materials having the desired bioresistant and / or bioactive properties and proper medical quality can be used as UZL material. For example, an UZL can be made of such non-absorbable, i.e. biodegradable material like nylon, polypropylene and the like. Alternative materials in the manufacture of ultrasonic ultrasound can be composite or monolithic and / or foamed plastic substances, as well as stainless steel, or another metal alloy, or another polymer with specified surgical properties;

4) a significant reduction in financial costs for surgical operations due to the rejection of the use of expensive CMM, which, according to available data, is effectively used only by 10%. This amount of material goes to the formation of a loop and a node fixing in the necessary position the edges of the wound. The rest (about 90%) is utilized in the very process of traditional suturing when suturing wounds;

5) the use of a new device prevents wound bleeding, reduces local tissue ischemia in the projection of sutures, which means the risk of postoperative suppuration of sutures, especially during surgical closure of accidental wounds. The proposed device potentiates wound healing by optimizing the course of the wound healing process when performing a castle ligature device made of a composite polymer material containing antibacterial and other biologically, chemically and physically active inclusions that allow, if necessary, to organize a prolonged flow of therapeutic agents directly into the area of the sutured bodily tissue defect;

6) in addition, the use of the new device prevents excessive deformation and scarring of stitched tissues and implements all the advantages of nodeless self-retention of CM while maintaining the universalism of traditional surgical techniques.

The use of this device will be especially useful in urgent surgery, traumatology, in field surgery and disaster medicine.

DESCRIPTION OF THE TECHNICAL SOLUTION

The claimed UZL, is intended to perform stitching when stitching a skin incision and / or wound of body tissue and fixing the ligature tension made of surgical materials and contains three sequentially located elements: the head end with the ligature body lock, the ligature body and its tail end.

- The head end begins the ligature lock device and is made in the form of a thickening on it with external atraumatically rounded surfaces and edges, while containing a through channel with a lock inside the channel. The channel is arranged in such a way that the lock does not interfere with the reception and subsequent advancement of the tail end and the ligature body inside the channel, up to the fixation of the desired area of the ligature body with the lock in the required position, permanently or permanently, for the desired period. Moreover, in some versions of the ultrasound, the closure and fixation of the ligature body in the head end remains stable for the entire period of operation of the ultrasound, in others it may provide for the possibility of controlled separation of the head end and the body of the ligature of the ultrasound, taking into account the specific clinical situation. These disconnections are achieved through the use at the head end of the structural elements that control the size of the channel of the head end of the ultrasound, and / or the position of the lock for fixing the ligature body - brackets, nuts, etc.

- The body of the ligature is made in the form of a segment of the core, providing unhindered passage of the body of the ligature through the body tissue and the channel of the head end, most often in one direction.

Part of the surface of the ligature body can carry a relief in the form of macroperforation or microperforation, which, when the ligature body passes through the body tissue, does not injure it due to the orientation of the protrusions and depressions of the relief of the ligature body, which contributes to the desired movement of the latter in the thickness of soft tissues.

Depending on the purpose of the UZL, the core in cross section can be made round or non-circular. A non-circular vein can have pronounced dorsal and ventral surfaces, ending with fillets at the edges. Such vein forms provide an atraumatic passage of the ligature body through the body tissue.

When the direction of movement of the body of the ligature through the channel at the head end, the lock is fixed on the body of the ligature.

Castle execution options:

1. in one of the UZL design versions, on the central part of one of the surfaces of the ligature body, opposite to the head of the device, there is a relief, the surface of which forms when fixing with the lock of the ligature body in the form of a relief a final or permanent connection for the desired period;

2. the lock is made in the form of a bracket crashing into the body of the ligature;

3. the lock is made in the form of a tightening nut, etc. - various options.

For example, the following series of well-known technical solutions described in analogues can be used: [3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13].

- The tail end has a shape suitable for its desired passage through stitched tissues, and then through the channel at the head end. Its shape is made in such a way that it causes the least irritation in the puncture channel. The tail end is either connected to a surgical needle, or is itself a surgical needle.

The absolute and relative sizes of the individual parts of the ultrasound system, their volume and spatial embodiment, together with other qualities of all its surfaces and internal contents, can vary significantly, depending on various factors, the most significant of which may be such as the size and prescription of the wound, and its anatomical location, a type of damaged tissue and the likelihood of contamination. In addition, we emphasize that the cross section of the ligature body and the caudal end of the ultrasound has a predominantly non-circular section, allowing a suitable way to increase the inner surface area of the new suture material. Moreover, the relatively smaller sizes (diameters) of non-circular cross sections for products with different thicknesses can lie in the range from about 0.001 millimeter to about 1.0 millimeter.

UZL can be made so that the length, width and thickness of the ligature can vary depending on the anatomical scope of the ligature product.

UZL can be made of absorbable, i.e. biodegradable material, which provides for the possibility of resorption of this new CMM in sutured tissues as they heal. Modern biodegradable polymers and copolymers dissolve over a wide time period (from 1 month to 2 years). The choice of a specific composition of biodegradable material should be determined by the desired resorption time of the new CMM.

A wide range of polymers and other materials having the desired, bioresistant and / or bioactive properties and proper medical quality can be used as UZL material. For example, UZL can be made of such non-absorbable - biodegradable material as nylon, polypropylene, etc. Alternative materials in the manufacture of ultrasonic treatment can be composite, or monolithic, and / or foamed plastic substances, as well as stainless steel or another metal alloy, or a polymer of surgical quality.

NOD can be made so that the tail end has a length and thickness sufficient to be inserted into a surgical needle.

NOD can be performed so that the tail end is used as a surgical needle.

The ultrasound can be made so that the tail end ends with a proper connection with a metal needle of surgical quality.

NOD can be performed such that the tail end ends with a transition, i.e. it is necessary by a strong connection with a polymer needle of surgical quality having increased stiffness compared to other parts of the ultrasound, while the needle is attached to the tail end using adhesives, crimping, crimping, or made by pressing the ligature body between the two halves of the needle.

Figure 1 shows the proposed actively implantable medical device - USL, which contains three main parts:

a) Head end - 1;

b) The body of the ligature - 2;

c) The caudal end is 3. It has pronounced surfaces: the outer (dorsal) is 4 and the inner (ventral) is 5.

In one embodiment, the USL material is flexible and mainly inelastic, so that the outside and interstitial geometry of the actively implanted, i.e. introduced CMM will be determined by the introduction path and the properties of the surrounding and stitched tissues - see Figure 2 (arrows indicate the direction of ultrasound in the thickness of the body tissue). However, in some applications of ultrasound, it may be desirable to perform it in such a way that the ligature body section would have sufficient dimensional stability - non-shrinkage, which allows creating a predominantly stable geometric configuration in stitched fabrics during the entire period of operation; and have sufficient elasticity to return to the desired position after any deviation from it.

The head end of the UZL, in one of the variants of its execution (but without limitation), has the form most similar to a hollow cube with atraumatically rounded edges (see Figure 3). The ratio of the length of the edge of the head end to the thickness of the body of the ultrasound can be expressed as a fraction 3/1; the edges of the head end of the ultrasound should be rounded to increase the non-invasiveness of surgical procedures.

At the most general consideration, the head end of the ultrasound scan looks like a thickening of the device in the dorsal direction by about two thicknesses of its body. The head end channel - 6 (in this embodiment) has a fixing element - 7 (see Fig. 3 section); the channel is designed for unhindered reception of the tail end and subsequent proper fixation, i.e. without unwanted retraction of the ligature body area, in view of the prospect of creating the equivalent of a traditional surgical suture ligature.

At the same time, the specific version of the final and / or controlled fixation of the body section of the ligature of the USL in the head part, the particular material used and all other technological and spatial parameters of the head end of the USL can vary depending on the specific anatomical areas of application and the clinical requirements for the predicted tension, loss of strength and service life, as well as elasticity, flexibility and the necessary biological inertness of the suture material we offer.

Further, we emphasize that, due to practical considerations, the head end of the UZL can be equipped with any effective and reliable version of the lock for fixing the ligature body in the desired position.

The body of the UZL is a predominantly non-circular vein (in this embodiment, ribbon-like, but without limitation) and is a direct continuation of the head end; can bear micro- and macroperforations, and at the same time, the length, width and thickness of the body of ultrasound can vary depending on the anatomical field of application of the ultrasound, and on the specific clinical requirements for the predicted tension, as well as loss of strength and service life, as well as elasticity, the flexibility and necessary biological inertness and / or reactogenicity of the newly proposed suture material. The inner - ventral surface of the body of the UZL, in this embodiment, has a special relief - 8 (see Figure 3), formed by transverse protrusions - 9 and depressions - 10, with rounded edges, which generally creates the conditions for proper and / or final fixation section of the body of the ultrasound in the head part through its permanent physical contact with the fixing element of the latter. The outer is the dorsal surface of the body of the ligature of the UZL, in this embodiment, it has a flat surface. The ligature body is monolithic and devoid of perforations; the ratio of the width of the body of the ligature of the UZL to its thickness can be approximately expressed as a fraction, as 3/1; the edges of the non-circular ligature of the USL ligature must be smoothed - rounded to increase the non-invasiveness of surgical procedures; the ratio of the length of the body of the ligature of the UZL to the length of the face of the head end can be approximately expressed as a fraction, as 30/1.

The tail end of the UZL is a direct continuation of its ligature body, and has the necessary shape suitable for its desirable passage through stitched tissues (but without limitation). The tail end of the ultrasound can be straight and curved. The terminal part of the tail end of the UZL adjacent to its sharp end can be made of sufficiently rigid material; so that the end of the device can be actively implanted, i.e. penetrate the stitched fabric, while the axial force is applied at the junction of the ligature body in the tail end.

In one of the options for the execution of ultrasound, the end of this CMM may be a surgical needle, which, mainly, can be made of stainless steel or another metal alloy of surgical quality. At the same time, the needles can be attached to the tail end with adhesives, crimping, crimping, or the connection can be formed using a heat-pressed tube.

Also, detachable connections of the tail end - 3 with the surgical needle - 11 can be used (see Figure 4). Moreover, the length and cross section of the needles can vary widely, and their specific choice is determined by the dependence on the properties of the stitched tissues, so that after the complete removal of the needles, the tail end and the body of the ligature of the UZL remain in the most favorable, i.e. desired position.

On Photo 2 and 3 - preparation for equipping the NOD with standard "reusable" surgical needles. Photo 4, 5, 6 - causing artificial damage to cadaveric pig skin.

The photo shows illustrations of the dynamics of surgical closure of a wound created artificially on cadaveric pig skin in the traditional way (see Photo 7-19) and using ultrasound (see Photo 20-28).

At the same time, the parameters of the trajectory of the passage of a new CMM reflected in the illustrations of the present invention through the wound sides are not restrictive, since any trajectory of active tissue manipulations during surgery is determined by the surgeon and depends on the specific clinical situation. Moreover, when using an ultrasound with straight tail ends for the surgeon, the possibility of creating indirect trajectories of its implementation in the tissues is not ruled out.

At the same time, in order to make it possible to visually compare the new and traditional methods of closing wounds of bodily tissues, these photographs show an approximate sequence of surgical procedures aimed at drawing closer, connecting and holding the wound in the closed position by means of active implantation of the cervical cord (holding) into the thickness of the stitched tissues, and the formation of the desired trajectory and depth of conduct). Further actions created the desired tension of the surgical ligatures and maintained it by tying the ends (see Photo 7-19) of the traditional surgical CMM, or by fixing the UZL elements in a knotless way (see Photo 20-28).

Further, we emphasize that all these photographs are not restrictive for the present invention, since they are presented here only for the convenience of analytical comparison of the stages of practical application of the new CMM with TSM.

In accordance with the present invention, explanations are given below for graphical illustrations of two options for connecting and holding the wound in the closed position (see: FIG. 2; 5 (a, b, c); FIG. 6 (d, e, f). it should be borne in mind that the operation of rapprochement of the sides - 12 and 13 of the wound, can be carried out after active implantation, i.e. advancement of the tail end - 3 and the ligature body - 2 in the thickness of stitched tissues - 14, thus with such a depth of trajectory, that after the complete removal of the needles - 11, the tail end - 3, the ligature body - 2 and the head end - 1 remains, in bark position for further surgical procedures.

Thus, completing the illustration of the present invention, the following comparative experimental data characterizing the results of checking the biomechanical characteristics of surgical sutures made in the traditional way, and using this version of the new suture material - USL.

Example 1:

A comparative strength test (ex situ) was carried out by testing for complete dissociation of the edges of closed standard linear incised wounds 5.0 cm × 1.5 cm × 0.5 cm. Artificially created on cadaveric pig skin. These injuries were inflicted on identical ones in length - 7.0 cm, width - 7.0 cm and thickness - 5.0 mm. plates of cadaveric pig skin were sutured using different amounts of ligatures (from 1 to 4) made of traditional and new suture materials of comparable thickness. Then, the free lower edge of the pig cadaver skin plate was stationary fixed on the plane of the laboratory table using portable locksmiths, while household spring scales with a scale from 0 to 10 kg were attached to the upper edge of each sample. The scales were then manually moved vertically — raised to create tension forces directed perpendicular to the horizontal plane of the sutured wounds in each specimen of pig cadaverous skin. In this case, the lifting of the weights was carried out until the complete dissociation of the sutured wounds occurred, and the peak force required to separate the closed incision was recorded in each of the eight observations as the tensile strength. The following is a graphical representation of the results of these comparative biomechanical tests.

Example 2:

A comparative assessment of the effectiveness (in vivo) of the ultrasound and TSM models was carried out when 32 artificially created wounds of the skin of 16 experimental animals were closed - dark mestizo dogs. The average age of the animals was 4.5 years, the average weight was 7.3 kg, and the sex ratio was 1: 1.

All experiments with this embodiment of the invention began with the production of local anesthesia (a tight creeping infiltrate according to Wisniewski 0.5% solution of novocaine) and standard preparation of the surgical field in the field of future surgical intervention. Then, almost equal sections of the skin with underlying fatty tissue were dissected up to the superficial fascia with two bordering oncoming cuts; as a result, a standard skin defect formed, having the following average values of its maximum linear dimensions: length 5.52 ± 0.601 (cm), width 1.18 ± 0.312 (cm), thickness 0.97 ± 0.355 (cm) . These defects were closed to half their length by separate interrupted sutures made of TShM (kapron thread 5 [57]). At the same time, the other half of the artificial wound defect was closed with a new suture material - UZL - of comparable thickness.

Subsequently, within 14 days, operated dogs were observed. In three cases (despite safety precautions), the animals completely cracked the stitches by the end of the first two days. The other two were bitten to about half, during the first day of the postoperative period. In all remaining cases (84.3%), the wounds healed normally throughout.

In other words, the data we found on the use of a new suture material (in vivo), under experimental conditions that exclude artifacts as much as possible, convincingly reflect the results of the practical realization of all the advantages of nodeless self-retention of the UZL loop while maintaining the retention ability and versatility of traditional surgical techniques.

It should be emphasized that despite the above description of one of the options for the preferred design of ultrasonic protection, it should be completely clear that this option is not restrictive, and specialists in this field may make changes, additions and exceptions to the invention. But at the same time, and in connection with the foregoing, it should be considered all such changes, exceptions, additions and equivalents are not beyond the scope of the following claims, and consistent with its spirit.

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Claims (14)

1. The ligature lock device that provides the stitch when stitching the skin incision and / or wound of body tissue, made of materials of surgical quality, characterized in that it contains three sequentially located elements: the head end with the lock of the ligature body, the ligature body and its tail end where the head end starts the ligature lock device and is made in the form of a thickening on it, has external atraumatically rounded surfaces and edges, while it contains a through channel with a lock inside, and the channel is designed so that the lock does not interfere with the reception and subsequent advancement of the tail end and body ligatures inside the channel, up to fixing the ligature body section with a lock, in the required position, permanently or permanently - for the desired period; the ligature body is a direct continuation of the cephalic end, made in the form of a segment of a vein and has a surface that allows the ligature body to pass through the body tissue and the canal of the cephalic end; the tail end is pointed and ends the ligature body, which ensures the desired passage of the tail end and the ligature body through stitched tissues and the channel at the head end. 2. The ligature lock device according to claim 1, characterized in that the ligature body has a non-circular section and pronounced surfaces: dorsal and ventral, with rounding at the ends, allowing the ligature body to pass through the body tissue and the through channel of the head end. 3. The ligature lock device according to claim 1, characterized in that the ligature body has a circular cross-section, allowing the ligature body to pass through the body tissue and the through channel of the head end. 4. The ligature locking device according to claim 1, characterized in that the surface of the ligature body has a relief. 5. The ligature locking device according to claim 1, characterized in that the surface of the ligature body does not have a relief. 6. The ligature locking device according to claim 1, characterized in that the tail end is straight. 7. The ligature locking device according to claim 1, characterized in that the tail end is made curved. 8. The ligature locking device according to claim 1, characterized in that the tail end is connected to a surgical needle. 9. The ligature locking device according to claim 8, characterized in that the surgical needle is attached to the tail end using adhesives, crimping, crimping, using a tube pressed by heating. 10. The ligature locking device according to claim 8, characterized in that the surgical needle is attached to the tail end using a detachable connection. 11. The ligature locking device according to claim 1, characterized in that it is made of a surgical-grade metal alloy. 12. The ligature locking device according to claim 1, characterized in that it is made of a composite polymer material of surgical quality, containing antibacterial biologically, chemically and physically active inclusions. 13. The ligature locking device according to claim 1, characterized in that it is made of biodegradable material of surgical quality. 14. The ligature locking device according to claim 1, characterized in that it is made of a biodegradable material of surgical quality.