WO2020036557A2

WO2020036557A2 - Suture with elasto-plastic characteristic and stabilization system

Info

Publication number: WO2020036557A2
Application number: PCT/TR2019/050298
Authority: WO
Inventors: Mehmet KABALCI
Original assignee: Kabalci Mehmet
Priority date: 2018-05-04
Filing date: 2019-05-06
Publication date: 2020-02-20
Also published as: WO2020036557A3

Abstract

The present invention relates to a suture with elasto-plastic characteristic and stabilization system thereof that can be used in practices including suturing, closure, securing, suspending, supporting, splinting as well as in cerclage applications of all osseous and soft tissues in surgical operations. In particular, the present invention relates to a suture material with elasto-plastic characteristics configured to immobilize bones and to reunite them tightly in procedures involving reunion of bones such as sternal reunion, a tensioning apparatus that applies tension to the suture in order to hold the relevant tissue firmly and a stabilization system thereof which can ensure that the suture maintains its final position after the tensioning operation is complete.

Description

SUTURE WITH ELASTO-PLASTIC CHARACTERISTIC AND STABILIZATION

SYSTEM

Technical Field The present invention relates to a suture and stabilization system with elasto-plastic characteristic thereof that can be used in practices including suturing, closure, securing, suspending, supporting, splinting as well as in cerclage applications of all osseous and soft tissues in surgical operations.

In particular, the present invention relates to a suture material with elasto-plastic characteristics configured to immobilize bones and to reunite them tightly in procedures involving reunion of bones such as sternal reunion, a tensioning apparatus that applies tension to the suture in order to hold the relevant tissue firmly and a stabilization system thereof which can ensure that the suture maintains its final position after the tensioning operation is complete. State of the Art

Anatomically, organs such as the heart and lungs are inside the thoracic cage. To be able to perform certain types of surgeries involving the heart, lung and major vessels such as aorta, surgeons have to gain access to the thoracic cavity or the cardiac cavity (mediastinum). Median sternotomy (which is a type of surgical procedure in which a vertical incision is made along the sternum) is one of the most commonly used methods in order to gain access to these cavities.

Subsequently, after the surgical operation is complete, several different methods and apparatuses are utilized for the closure of the thoracic cage and incorporation of tissues. Soft tissues and osseous tissues are among the tissues that are to be fused together after the surgical operation. While performing procedures such as suturing, stabilization, suspending, supporting, splinting as well as in the practice of cerclage carried out for the reunion of these mentioned tissues, different materials called sutures are used. In terms of raw materials used in their manufacturing, suture materials can be divided into two groups as inorganic and organic. While organic sutures are coming from a biological origin, inorganic sutures can be manufactured from metal alloys or synthetic materials. Metallic materials in the form of suture or prosthesis may further be divided into two groups as magnetic resonance imaging compatible/incompatible (affected/unaffected by the magnetic field). Magnetic resonance imaging (MRI) systems are inclined to pull metal objects to themselves due to powerful magnets integrated within, the fact that whether these suture materials are affected by the magnetic field created by magnetic resonance imaging machines or not is of vital importance. If a material that is inclined to be affected by a magnetic field (MRI incompatible) is used on an incision, the mentioned suture would be exposed to severe vibrations during magnetic resonance imaging and would cause damage to both itself and surrounding tissues thereby, resulting in serious heating of suture material. Inorganic sutures (whether it is of metallic or not) are further divided into two groups as visible in X-Ray and suchlike imaging systems (fluoroscopy, etc.) and invisible (radiopaque/radiolucent) sutures. A further separation can be made as absorbable and nonabsorbable by human body in terms of biodegradation or dissolution within the tissue. As for structural form, sutures can be further divided into two groups as sutures and tapes. Furthermore, these can be divided into two groups in terms of structural features once again as monofilament sutures and multifilament sutures. Several different types of sutures having combinations of above-mentioned characteristics are utilized in various branches of surgical operations.

In particular, since the force imposed on sutures in surgical specialties such as orthopedics, neurosurgery, thoracic surgery and heart surgery is quite high, surgeons are commonly inclined to prefer the use of metal sutures and/or metal prostheses and/or metal screw systems. Several different types of metal including titanium, platinum, stainless chrome-steel, alloys of nitinol which are both highly resistant and biocompatible are commonly used in these fields.

However, metal materials have various disadvantages to provide reunion of both osseous and soft tissues. Despite the fact that tissue compatible metals are used in above-mentioned procedures, most of the time these metal materials which are commonly inserted in order to provide support to tissues as well as unifying elements, are required to be extracted subsequently due to the large quantities of volume they occupy. Moreover, the placement of these implants further challenges in various characteristics. One of the main problems experienced in using of metal sutures is the necessity of fixation of the end side of the metal suture after passing through the tissue, or retain by means of an equivalent buckle, bands, rings, screws or suchlike apparatuses. Furthermore, after the metallic suture is passed through the tissue, removal of the extra space by means of tensioning the suture is much harder when compared to more flexible non-metallic sutures.

Particularly in open heart surgery, after a vertical incision is made along (longitudinally) the sternum, monofibril stainless steel is the most commonly used suture type in the closure of the sternum (reunion of sternum) during the final stage of the surgery. A cerclage application is performed by using steel wires by means of perforating the bone or by passing the wire through the gaps between the costae (ribs) around the sternum and knots are tied to these wires by means of swiveling through the use of a plier-like apparatus (Porte-aiguille- needle holder).

The purpose of this practice is to provide support to the osseous structure that is split in half until these two parts of bone rejoin together and to keep them in an immobile position in which these two parts are in close contact with one another as much as possible. If this practice fails, beginning with the infection in the first place, several different fatal complications may develop.

Since its surface of contact with bone tissue is quite thin, stainless steel suture may induce osseous deformations as a result of certain actions such as coughing. The fact that the elastic phase value of the steel wire that is being utilized is low and that the wire stretches due to exhibiting plastic phase characteristics under major forces and that it cannot revert back is yet another problem experienced by surgeons. Additionally, irreversibly unfastening of the knot that is obtained through twining even after being exposed to low forces is another problem experienced in this field.

If the wire twined inappropriately (more or less) the wire may create a gap on the bone or may result in disadvantageous situations in which the bone may become deformed by wearing down. In order to obtain a knot that is both secure and that will not weaken the metal, the wire must be bent by holding the wire with the end side of the needle- holder in a manner that it will remain in an even angle. However, this usually depends on the person who is tying the knot and snapping of wire during the tying phase is a commonly experienced problem. Since there is no mechanism that measures/controls/limits the tension on the wire and/or on the bone, the wire may fail or may not create a stabilizing force on the bone. Many different inventions have been developed in order to eliminate this problem, however, an extensive usage of these inventions was not achieved.

Therefore, the tissue reunion may be disrupted, and life-threatening infections may develop due to sternal dehiscence. Sharp-edged osseous pieces may sever the major vessels and the vessels that are subjected to bypass operation under the bone and may cause lethal complications. Moreover, a condition such as this may be the source of an excruciating pain for the patient.

Various alternative products were developed in order to eliminate this particular problem. One of these products is multifilament woven steel wire.

Multifilament steel wire is a metal suture that provides better elastic features when compared to monofilament steel suture and it is more durable against plastic stretching. It was initially used in surgical operations performed in the field of orthopedics. Although the strength of the mentioned material is high, it poses certain disadvantages. In a case a narrow-angle plication occurs, it can be highly fragile and therefore, being able to tie a knot is impossible. Therefore, a locking system was developed in order to utilize as a substitution for tying a knot on the wire. Subsequently, after end side of wires that are moved into knot position passed through a pipe-shaped, crushable part having many different names such as the ring or domino, this ring/domino part is crushed for fastening of the wire. This apparatus which is designed for tensioning as well as tightening constitutes disadvantages since it is quite large in size, unpractical, complex in terms of use and non-ergonomic. In order to ensure that mentioned domino is crushed in a manner that it will not allow the wire to slide away, it has to be crushed and squeezed by applying a very high intensity of force, nevertheless, the wire may slip through the domino and may result in the separation of bones. In consequence of a preliminary search conducted in the state of the art, the patent application numbered US51 16340 was examined. The mentioned invention relates to a method for surgically securing body parts with a cable.

In consequence of a preliminary search conducted in the state of the art, the patent application numbered US5536270 was examined. The mentioned application discloses a cable system for bone stabilization to be used in surgical operations.

Various polymer-based raw materials that can withstand forces with higher intensity than stainless monofilament steel wire was manufactured in woven wire/cable or tape forms. The most essential problem of various inorganic materials such as elastane, polydioxanone, polyethylene, polyolefin, polyester, polypropylene, ABS, polyglactin, aramid, polyetheretherketone, carbon fiber, polymer and fiberglass that their forms that can carry loads in this magnitude cannot be tied with a secure knot. Furthermore, not only tensioning but also tying a knot with these materials is another technical challenge. Concisely, there is a necessity towards special designs/inventions that can ensure both tensioning and securing these materials.

In consequence of a preliminary search conducted in the state of the art, the patent application numbered US4730615A was examined. The mentioned invention relates to a sternum closure device for closing the sternum of a patient comprising a head portion, tail portion and flexible spine portion. The head portion comprises a locking tang in order to prevent backward movement of the spine portion once it is received and engaged in the head portion.

Tape forms of these sutures became available as a result of enlarging the surface area of the suture used for the purpose of reducing the pressure created on the bone in the sternal closure operation (i.e. bringing pieces closer to one another and securing it tightly in a fixated position). One of the first tape-formed sutures is steel tape. The greatest disadvantage of these steel tapes is that tying a knot with them is quite a challenge. Moreover, since the material is quite thick, controlling it while passing through the tissue is very difficult and accordingly deemed discomforting by surgeons. Yet another disadvantage with the large surface area is experienced during tensioning stage. Quite a large amount of force is required in order to ensure that the material is tensioned until it comes into contact with the bone and the apparatus that is widely accepted, practical, easily controlled and ergonomic is yet to be designed.

To be able to take advantage of wide surface area principle, easily manipulable tapes that can be locked on itself were manufactured from an abovementioned polymer or metal raw materials. Durability forces in linear form (some being stronger while others are weaker) resemble stainless steel wire. The major frailty of this particular material is that the auto-locking mechanism releases itself, gets deformed or breaks apart a lot sooner than the material's itself.

In consequence of a preliminary search conducted in the state of the art, the patent application numbered US2015305792 was examined. The mentioned invention relates to a bone fixation system that includes at least one bone fixation member and a bone fixation instrument.

Yet another invention used for sternal closure is that engaging, screwed, tabbed products having their own mechanisms that are designed as prostheses. Primal disadvantages of these prosthesis-like products can be adduced as the fact that they are quite crude, they are unable to hold the tissue completely, they are not cost- efficient, they are not ergonomic in terms of surgeon's application and that their use causes loss of time. Titanium or medical metal alloys are among the preferred materials for these products.

Another prosthesis-like product is nitinol clips. The fact that mentioned invention does not comprise any moving mechanism has rendered this particular invention less complicated. It is solely based on reformation induced by temperature changes. Used together with its custom-engineered applicator, this product constitutes many different disadvantages inclusive of posing difficulties in implementation, creating a mound under the skin due to its crude structure and technique's inability to provide any additional success.

Cardiothoracic operations being in the first place, crudeness of this particular product constitutes a major problem in operations in which osseous tissue is much closer to the skin. The fact that patients can feel the locking mechanisms over their skin due to the size of these mechanisms, that they induce pain and even that they cause lacerations on the skin by traumatizing it are major problems. Despite the fact that soft tissues such as muscle and adipose tissues are able to mask this problem due to their thickness particularly in operations performed in the field of orthopedics, designing locking mechanisms that are slim in structure is important for surgical fields in which surgeons are forced to operate on thinner subcutaneous tissues. Particularly in pediatric heart surgeries where surgeons perform operations on the skin and subcutaneous tissues that have millimeters of thickness, these problems pose serious difficulties.

In consequence of a preliminary search conducted in the state of the art, the patent application numbered US20150080895(A1 ) was examined. The mentioned patent application discloses a prosthesis-like closing member for sternal closure in both human and animal bodies.

The invention numbered as W02008073898 in the state of the art relates to a prosthesis-like material developed for the closure of a gap created as a consequence of a vertical inline incision is made along the sternum. Since areas in which this particular material is used for osseous healing cover the cleft portion of vertically incised sternum, it becomes unlikely to open the thoracic cage by means of a bone saw in case of emergencies.

The patent application numbered US20020128654 in the state of the art relates to a method and a prosthesis-like apparatus developed for the fixation of various bone fractures. The structure of mentioned apparatus poses disadvantages in terms of reassembly of the apparatus following the interventions performed on a patient in case of an emergency.

In consequence of a preliminary search conducted in the state of the art, the patent application numbered US20050240189 was examined. The mentioned invention relates to a device and a method for joining a severed sternum. The mentioned sternum joining element is manufactured from a material selected from a group consisting of stainless steel, titanium, shape memory alloys, superelastic alloys and polymers. In the mentioned invention, superelastic alloy or shape memory alloy is nitinol. In consequence of a preliminary search conducted in the state of the art, the patent application numbered US7803176 was examined. The mentioned invention relates to a sternal closure clamp device for securing and retaining longitudinally divided halves of a sternum. In consequence of a preliminary search conducted in the state of the art, the patent application numbered US2017172636 was examined. The mentioned patent application discloses a sternal closure assembly for securing the first and the second lateral halves of a sternum. The first body and the elastic deformation is joined together with a strong bond between the male and female portions. In consequence of a preliminary search conducted in the state of the art, the patent application numbered US2013178906 was examined. The mentioned invention relates to systems, devices and methods for longitudinal closure of a dissected sternum.

Consequently, even though the inventions provided thus far has eliminated at least one problem from its own point of view, they created even more disadvantages and thereby have failed to make a persistent contribution to the elimination of problems. Additionally, the fact that these inventions developed thus far cannot be implemented ergonomically by a single surgeon without causing loss of time is yet another important problem.

Problems the Present Invention Seeks To Solve

The main aim of the present invention is to double the force on the buckle, by using the point of support when applying force to the suture, like pulley block. Thus, not only the tensioning can be performed with half the force but also the force required for the prevention of suture's unraveling is doubled. Another aim of the present invention is to prevent suture breaks and slides by means of the buckle having different geometrical shapes. Thus, a secure and highly durable buckle can be obtained. Yet another aim of the present invention is to provide a product that can be used in cases where there is hardly any subcutaneous tissue or where subcutaneous tissues are thin.

Another aim of the present invention is to provide a stabilization system consisting of an elastoplastic suture that is safe, secure, durable, ergonomic, easily applicable, that does not cause the surgeon to lose time, that does not discomforts the patient, that does not cause any traumatization or damage on the tissue prior to and/or during and/or after the application, and that does not cause any damage to the material prior to and/or during and/or after the application; a hand apparatus that can be used as tensioning element for the suture; and a locking buckle and thereby, securing the sternum and/or other tissues.

Yet another aim of the present invention is to provide a suture with elastoplastic characteristic and stabilization system thereof that can be used in practices including suturing, closure, securing, suspending, supporting, splinting as well as in cerclage applications of all osseous and soft tissues.

Another aim of the present invention is to ensure that the inflammatory reaction given by human body to foreign bodies is taken under control and/or to add an anti-microbial feature to the invention by means of coating the elastoplastic suture material with bioactive materials.

Yet another aim of the present invention is to strengthen the weak parts on the bone with "bracket-crochet" like design in order to securely carry the load on edges and/or other weak spots on the gathered material. Therefore, sizes of buckles are designed in a manner that they will be supportive to weak spots on the relevant tissue.

Another aim of the present invention is to ensure the tensioning of materials that are utilized with a tensioning system with proper force and secure, durable, ergonomic, easily applicable, that does not cause the surgeon to lose time, that can measurable and/or controllable and/or the torque in analog or digital manner or without comprising this particular feature that does not cause any damage or trauma on the tissue prior to and/or during and/or after the application, that does not cause any damage to the material. Yet another aim of the present invention is to allow for utilizing one or some of various materials that are used in several industrial fields and/or in medicine or that are not actively used in medicine individually, together and/or compositely, and that allows for utilizing wide surface area, proper flexibility, high force resistance, resistant against time, that is highly biocompatible with the tissue, that prevents tissue trauma during and/or after the application, that provides comfort to the patient as well as providing ergonomy and opportunity of easy application to the surgeon and that does not cause any time loss, that does not necessitate more than one person for implementation.

Another aim of the present invention is to allow for utilizing composite materials that are capable of bringing various properties together as suture and to provide a locking mechanism that is capable of securing this suture safely. Thus, it is aimed to eliminate problems and disadvantages in the state of the art by means of utilizing the portion that will tension the suture on the bone with a proper amount of force.

Structural and characteristic features and all advantages of the present invention will be understood more clearly with figures and the detailed description provided herein by means of making references to these figures. Figures provided below serve solely for the purpose illustration and these designs or various other designs that are in accord with terms disclosed in the detailed description can also be used.

Description of the Figures:

FIGURE 1 illustrates the frontal cross-section view of the tensioning gun according to the inventive system.

FIGURE 2 illustrates the frontal view of the tensioning gun according to the inventive system.

FIGURE 3 illustrates the isometric view of the tensioning gun according to the inventive system.

FIGURE 4 illustrates the frontal view of the screwed buckle according to the inventive system. FIGURE 5 illustrates the perspective view of the screwed buckle according to the inventive system.

FIGURE 6 illustrates the perspective view of the riveted buckle according to the inventive system.

FIGURE 7 illustrates the frontal view of the spring buckle according to the inventive system.

FIGURE 8 illustrates the perspective view of the spring buckle according to the inventive system.

FIGURE 9 illustrates the perspective view of the wedged buckle according to the inventive system.

FIGURE 10 illustrates the frontal view of the buckle with clamp according to the inventive system.

FIGURE 11 illustrates the perspective view of the buckle with clamp according to the inventive system.

FIGURE 12 illustrates the frontal view of the slidable wedged buckle according to the inventive system.

FIGURE 13 illustrates the perspective view of the slidable wedged buckle according to the inventive system.

FIGURE 14 illustrates the view of the slidable spring buckle according to the inventive system.

FIGURE 15 illustrates the isometric frontal view of the buckle with clip according to the inventive system.

FIGURE 16 illustrates the perspective view of the buckle with clip according to the inventive system.

FIGURE 17 illustrates the isometric frontal view of the spring profile buckle according to the inventive system. FIGURE 18 illustrates the perspective view of the spring profile buckle according to the inventive system.

FIGURE 19 illustrates the view of the suspension buckle according to the inventive system.

FIGURE 20 illustrates the isometric frontal view of the ball buckle according to the inventive system.

FIGURE 21 illustrates the sectional view of the ball buckle according to the inventive system.

FIGURE 22 illustrates the view of the tensioning buckle according to the inventive system.

FIGURE 23 illustrates the perspective view of the tensioning buckle according to the inventive system.

FIGURE 24 illustrates the view of the ring buckle according to the inventive system.

FIGURE 25 illustrates the view of the split ring buckle according to the inventive system.

FIGURE 26 illustrates the view of the split ring buckle according to the inventive system.

FIGURE 27 illustrates the view of the strip ring buckle according to the inventive system.

FIGURE 28 illustrates the view of the open-end ring buckle according to the inventive system.

FIGURE 29 illustrates the view of the uniform suture ring buckle according to the inventive system.

FIGURE 30 illustrates the general view of the inventive system. Reference Numerals:

1. Stabilization System

100. Locking Element

101. Screw

102. Rivet

103. Wedge

104. Clamp Screw

105. Wedge Clamp

106. Clip Screw

107. Latch Spring

108. Ball

109. Plate Tab

110. Locking Ring

200. Tightener

201. Plate

202. Screw Socket

203. Spring

204. Tightening Wedge

205. Clamp

206. Slidable Part 207. Spring Wedge

208. Clip

209. Latch

210. Hinged Plate 300. Buckle

400. Suture Channel 500. Suture 600. Point of Support 700. Tensioning Apparatus 701. Palm Grip

702. Tensioning Trigger

703. Gear Lower Latch

704. Gear Upper Latch

705. Tensioning Gear 706. Suture Socket

707. Tensioning Pulley Description of the Invention

The inventive stabilization system (1 ) is used in suturing and rejoining of osseous and soft tissues after a surgical operation. In particular, the inventive stabilization system (1 ) is used in operations that require bones such as the sternum to remain immobile and which necessitate that these bones are tightly rejoined. The inventive stabilization system (1 ) is comprised of an elastoplastic suture (500) that is safe, secure, durable, ergonomic, easily applicable, that does not cause the surgeon to lose time, that does not discomforts the patient, that does not cause any traumatization or damage on the tissue prior to and/or during and/or after the application, and that does not cause any damage on the material prior to and/or during and/or after the application; a tensioning apparatus (700) that can be used as tensioning element for the suture (500); and a buckle (300). The phrase "prior to" used herein describes the preliminary preparation activities such as sterilization, packaging, transferring and manufacturing; the expression of "during" describes the perioperative stage, namely, the administration phase; and the expression of "after" describes the postoperative actions such as the healing stage and continuation of life.

The inventive stabilization system (1 ) is basically comprised of three main elements which are buckle (300), suture (500) and tensioning apparatus (700).

The suture (500) has two ends which are; the entry end, namely, the entry suture (501 ) and an exit end thereof, namely, the exit suture (502). The suture (500) reaches to the buckle (300) by means of surrounding (cerclage) the osseous tissue. The suture (500) can be passed through the suture channels (400) in different combinations. Various applicative sequences can be preferred based on ease of tensioning and loosening. In each buckle (300) embodiment, the suture (500) comprises at least one entry suture (501 ) and at least one exit suture (502). The suture (500) can be all kinds of biocompatible materials including elastane, polydioxanone, poliglecaprone 25, polyethylene, polyolefin, polyester, polypropylene, ABS, polyglactin, aramid, polyetheretherketone, carbon fiber and suchlike polymers and biodegradable materials and fiberglass, nitinol, platinum, titanium, stainless steel; and/or a form thereof that is shaped as a tape-strip/tabbed strip; and/or compositions thereof that are physically or chemically combined and/or coated with, their monofilament string form, multifilament string-rope-cable forms or woven tape-ribbon-strip forms. Again, these binding materials can be coated with rubber, silicone, epoxy and any other material that can be equivalent to these materials.

The suture (500) passes through the buckle (300). This portion which allows the suture (500) to pass through can be constituted by shaping the suture (500) itself or by a separate buckle (300) component. The suture (500) can be utilized in following structures which are provided for illustrative purposes down below. The following elements are provided for illustrative purposes only and the number of these examples can be increased further by using all combinations of abovementioned materials.

• Polypropylene-polyester strap (circle) composite tapes,

• Polyethylene or ultra high molecular weight polyethylene (UHMWPE) monofilament tapes, multifilament woven/twined tapes,

• Polyester-polyamide composite tapes, spun thin ropes,

• Elastane/polyester multifilament woven/knitted tapes of spun thin ropes,

• Elastane/polyester/polyamide composite multifilament woven/knitted tapes or spun thin ropes,

• UHMWPE/elastane/polyester/polyamide composite multifilament woven/knitted tapes of spun thin ropes,

• Aramide/polyester composite multifilament woven/knitted tapes or spun thin ropes,

• Aramide/polyester/fiberglass composite multifilament woven/knitted tapes or spun thin ropes,

• It can be used compositely with various raw materials such as aramid multifilament woven/knitted tapes or spun thin ropes.

In pediatric surgeries, utilization of absorbable sutures (500) is quite crucial in terms of allowing pediatric development and growth. Therefore, the suture (500) can also be manufactured from bioabsorbable materials such as polydioxanone, poliglecaprone 25 which are absorbable by the human body. Apart from this, any other absorbable material can also be used.

As seen in Figure 1 , the suture (500) is inserted inside the tensioning apparatus (700) through the suture sockets (706) by using the palm grip (701 ). Each time the tensioning trigger (702) is pulled by the user using his/her index finger, the tensioning gear (705) rotates around its own shaft, thereby rotating the tensioning pulley (707) in which the suture (500) located in the same direction. Thus, the suture (500) begins to wind around the tensioning pulley (707) on which the suture (500) is located. Gear lower latch (703) can be produced in a torque adjustable manner. Once the element having the feature of a spring of which room for flexibility is predetermined, exceeds the adjusted force, it will move up to a thread. A second torque adjusting mechanism is positioned on the shaft which provides the connection between the suture socket (706) and the tensioning gear (705). This shaft is directly integrated with the tensioning gear (705), however, the suture socket (706) is connected with the tensioning pulley (707) by means of a torque spring. Accordingly, once the appropriate tension is exceeded, tensioning trigger (702) rotates the tensioning gear (705), however, this rotating motion cannot achieve a force that will rotate the tensioning pulley (707) thus, the tensioning pulley (707) does not rotate. As both of these systems can be used together, only one of them can be utilized as well. Locking gear lower latch (703) and gear upper latch (704) move freely on their own central shafts.

When the tensioning operation is completed at an appropriate intensity of force, buckles (300) are locked and this operation is brought to an end by cutting the suture (500). Tensioning apparatus (700) is removed by pulling the suture (500) away. For the next operation of the suture (500), same procedure is applied once again.

Buckle (300) is basically comprised of locking element (100), tightener (200), suture channel (400) and point of support (600). Buckle (300) is used in more than one different geometrical shapes and structures. All embodiments of the buckle (300) comprises at least one locking element (100), at least one tightener (200), at least one suture channel (400) and at least one point of support (600).

By means of the point of support (600), one unit of force applied to the exit suture (502) provides two units of tensioning force on the buckle (300).

Since the entry suture (501 ) is rotated around the point of support (600), when entry suture (501 ) is tightened in a manner that it will create one unit of friction force inside the suture channels (400) before the suture (500) comes out of the buckle (300) as the exit suture (502), the suture does not slide away so long as two units of unraveling/loosening force are not applied to the buckle (300).

Results of the test conducted in order to measure the tensioning force applied to the suture (500) passing through the buckle (300) are provided in Table 1 down below.

Table. 1

Different structures and various geometrical shapes of the buckle (300) are given in detail down below.

In the embodiment shown in Figure 4 and Figure 5, the locking element (100) is in the form of a screw (101 ), while the tightener (200) is in the form of a plate (201 ).

The screw (101 ) allows the plate (201 ) to move towards the buckle (300). Thus, the suture (500) that remains in between the plate (201 ) and the buckle (300) can be tightened. Once the screw is tightened to its limit, the system gets locked in a manner that will prevent loosening. Screw socket (202) which allows the locking screw (101 ) to pass through, is positioned on the plate (201 ). The screw (101 ) which is placed inside mentioned screw socket (202), subsequently moves inside the grooved screw channel which is located on the buckle (300). Suture channels (400) through which the suture (500) enters into and comes out, are located within the buckle's (300) body. Although the number of these suture channels (400) may vary, the illustration shown in Figure 4 comprises four of these channels.

The suture (500) is tensioned in a manner that will provide a strong grip in the required amount by means of the suture tensioning apparatus (700). The tightening plate (201 ) immobilizes the suture (500) by means of applying force to suture (500) on points of support (600) in a manner that will prevent any loosening. For immobilizing the suture, required intensity of force is provided by the screw (101 ). When the locking screw (101 ) is tightened, it pushes the tightening plate (201 ) towards the suture (500), thereby performing a locking action. In case of need, the suture (500) can be loosened rapidly by means of loosening the locking screw (101 ).

In addition to screw (101 ), mentioned locking operation can also be carried out by a rivet (102). As it is shown in Figure 6, locking is performed by the locking rivet (102) on the same system.

In the embodiment shown in Figure 7 and Figure 8, locking element (100) is in the form of a wedge (103) and the tightener (200) is in the form of a spring (203).

The suture (500) is passed through the suture channels (400) located on the buckle (300) and the tensioning adjustment is performed by means of tensioning apparatus

(700). Tightening spring (203) applies pressure to the suture (500) horizontally and ensures that the suture (500) is tightened and remains tensioned. The spring (203) applies force to the suture (500) at the points of support (600) and provides assistance in immobilization of the suture (500). After the tensioning adjustment is made, locking wedge (103) is moved, thereby ensuring that the suture (500) remains immobile and it is prevented from moving. Locking wedge (103) is moved within the wedge channel. Locking wedge (103) is in a structure that expands from end portion to the top portion and therefore, by means of the horizontal movement within the wedge channel, it ensures that suture (500) that is located both below and above gets locked. Suture channels (400) through which the suture (500) enters into and comes out, are located within the buckle (300). While the number of these suture channels (400) may vary, in the illustration shown in Figure 7 and Figure 8, four suture channels (400) having geometrically triangular shapes are being demonstrated. These suture channels (400) are symmetrically positioned on both sides of the buckle (300) in a manner that there will be two channels at both sides.

In this embodiment, in addition to the spring (203), a tightening operation can also be performed by the tightening wedge (204). As it is shown in Figure 9, the tightening is provided by the tightening wedge (204) in the same system.

In the embodiment shown in Figure 10 and Figure 1 1 , locking element (100) is in the form of a clamp screw (104) while the tightener (200) is in the form of a clamp (205).

The suture (500) is passed through the suture channels (400) located on the buckle (300) and the tensioning adjustment is performed by means of tensioning apparatus (700). The clamp (205) applies pressure to the suture (500) and ensures that the suture (500) is tightened and remains tensioned. The clamp (205) applies force to the suture (500) at the points of support (600) and provides assistance in the immobilization of the suture (500). After the tensioning adjustment is made, clamp screw (104) is tightened, thereby ensuring that the suture (500) remains immobile and prevented from moving. Clamp screw (104) moves inside the channel positioned on the clamp (205).

In the embodiment shown in Figure 12 and Figure 13, locking element (100) is in the form of wedge clamp (105), while the tightener (200) is in the form of the slidable part (206). Buckle's (300) body has the shape of a rectangular pipe. The wedge clamp (105) is positioned in the middle of the buckle (300). Slidable parts (206) are symmetrically positioned on both sides of the wedge clamp (105) in a manner that at least two of these parts are located on each side. Slidable parts (206) are capable of moving in a uniaxial manner within the buckle (300). The buckle (300) serves as a cradle for these slidable parts (206). Gaps created between mentioned slidable parts constitute the suture channel (400). In this embodiment, there are a total of six suture channels (400) symmetrically positioned on both sides of the buckle clamp (105) which are distributed in a manner that each side has three of these channels. Once the suture (500) which is passed through these suture channels (400) is tensioned, slidable parts (206) begin to move towards one another and ensures that the suture (500) remains tensioned. Slidable part (206) applies force to the suture (500) at the points of support (600) and provides assistance in the immobilization of the suture (500). After the tensioning adjustment is made, locking action is performed by means of the wedge clamp (105) and thus, the suture (500) is prevented from moving.

In the illustration given in Figure 12, four slidable parts (206) are used. Two of them located in the middle serve as points of support (600).

In this embodiment, in addition to the wedge clamp (206), the tightening operation can also be performed by the spring wedge (207). As it is shown in Figure 14, the tightening is provided by the spring wedge (207) in the same system. Spring channel that allows the spring to move is positioned on the spring wedge (207).

In the embodiment shown in Figure 15 and Figure 16, locking element (100) is in the form of clip screw (106), while the tightener (200) is in the form of a clip (208). Flerein, the buckle (300) which consists of two clips (208) has a hinged structure. Gaps created with the closure of mentioned clips (208) constitute the suture channel (400). The tension of the suture (500) which passes through these suture channel (400) is adjusted by means of clips (208). After the suture's (500) tensioning adjustment is complete, mentioned suture (500) is locked by means of the clip screw (106). Another retainer or a tightener (200) can also be used instead of the clip screw (106). Clip screw (106) that is positioned within the gap located on each clip (208), ensures that these clips (208) remain together tightly and that the suture is immobilized (500). The clip (208) applies force to the suture (500) at the points of support (600) and provides assistance in immobilization of the suture (500).

In the embodiment shown in Figure 17 and Figure 18, locking element (100) is in the form of a latch spring (107), while the tightener (200) is in the form of a latch (209). A shaft that allows for moving the latch (209) is positioned on the buckle (300). A latch spring (107) which serves as a locking element is positioned on the latch (209). The gap created between the latch (209) and the body of the buckle (300) constitutes the suture channel (400). Once the suture (500) is passed through the suture channel (400), its tension is adjusted by means of the tensioning apparatus (700) and tightened by means of the tightening latch (209). After the adjustment is performed, immobilizing of the suture (500) is ensured by means of the locking latch spring (107) located within the latch (209). The latch (209) applies force to the suture (500) at the points of support (600) and provides assistance in immobilization of the suture (500).

The latch (209) which is used for the tightening operation in this embodiment, can also be used in the form illustrated in Figure 19. In this embodiment, one end of the buckle (300) can be flat suture channeled (400) while its other end can be latch (209) channeled.

In this embodiment, in addition to latch spring (107), locking action can also be performed by the ball (108). As it is shown in Figure 20 and Figure 21 , locking is ensured by the ball (108) in the same system. After the tension of the suture (500) is adjusted, suture (500) is immobilized by means of being dropped into the locking gap through being moved within the ball channel of the ball (108). In this embodiment, one end can be flat suture channeled (400) while the other end can be a ball (108) channeled.

In the embodiment shown in Figure 22 and Figure 23, locking element (100) is in the form of plate tap (109) while the tightener (200) is in the form of the hinged plate (210). Flerein, the buckle (300) which consists of two plates has a hinged structure. Suture channels (400) are positioned on the bodies of the hinged plate (210) which is located on the buckle (300). After the suture (500) is passed through the suture channels (400), tensioning is performed by means of drawing hinged plates (210) closer to each other. In this embodiment of the buckle (300), tensioning apparatus (700) is not required for performing the tensioning operation for the suture (500). Since the suture channels (400) are eccentrical to the hinge point, sutures (500) become tensioned, as the plates (210) are closed by means of drawing them closer to each other. After the required tension is obtained and the buckle (300) is closed, suture (500) is immobilized by means of tightening the last locking plate tab (109) towards the hinged plate (210). Flinged plate (210) applies two units of force to the suture (500) by means of the point of support (600) and provides assistance in immobilizing of the suture (500).

In the embodiment illustrated in Figure 24, the locking element (100) and the tightener (200) are in the form of locking rings (1 10). The gap created by the locking ring (1 10) positioned on the buckle (300) and the point of support (600) constitutes the suture channel (400). The suture (500) is initially passed around the point of support (600) in the desired way and through the suture channel (400), and its tension is adjusted by means of the tensioning apparatus (700). After the tension is adjusted, force is applied to the locking ring (1 10) and accordingly ensured that the suture (500) that remains in between the body of the buckle (300) and the locking ring (1 10) is tightened and immobilized. As the locking ring (1 10) can be crushed flatly, it can also be crushed in a manner that creates a zigzag shape. The term "zigzag" used herein, means that the locking ring (1 10) is crushed in a manner that it will create more than one edge, more than one contact point and more than one peak point.

As the buckle (300) illustrated in Figure 24 can be used in a uniform structure, it can also be used in a manner in which it may comprise individually more than one part. As it is illustrated in Figure 25, after two sutures (500) that pass through the point of support (600) which is located in the middle are tensioned by means of the tensioning apparatus (700), two units of force are applied by means of the point of support (600) and the suture (500) is immobilized by means of crushing locking rings (1 10) which are located at different ends. In this embodiment, the point of support (600) also serves as a suture channel (400). In addition to this, a point of support (600) can be created by means of nestling the sutures (500) in one another without using a separate ring and thus, two units of force can be created. Tension adjustment can be performed by the tensioning apparatus (700) and it is ensured that sutures (500) are immobilized by means of crushing locking rings (1 10). This particular embodiment is illustrated in Figure 26.

The mentioned structure can be constituted in different ways. As it is shown in Figure 27, the buckle (300) can also be used as ring-shaped points of support (600) located at both above and below in the middle of mentioned buckle (300) and locking rings (1 10) at each end, in a geometrical shape in which sutures (500) come into contact with each other.

As it is shown in Figure 28, the end of the locking ring (1 10) can also be open. Thus, the difficulty of passing the suture (500) through the locking ring (1 10) in confined spaces is eliminated. In the embodiment illustrated in Figure 29, one of the ends of the suture (500) is used with the buckle (300) in one piece, while the locking ring (110) positioned at the other end can be in an open or closed geometrical shape as stated above. Thus, tensioning and locking operations can be performed through one end. In the entire stabilization system (1 ), sutures (500) are rotated in the opposite direction through a point of support (600) that is positioned on the buckle (300) and based on simple pulley-block logic, one unit of force applied to the exit suture (502) creates two units of tension force on the buckle (300). Thus, one unit of loosening force created due to motions of the body and bone can be controlled at the point of tightening with a half unit of friction force.

When the entry suture (501 ) and the exit suture (502) are exposed to forces that are in opposite directions, they create friction force, thereby providing assistance in locking of the buckle (300). In order to immobilize the suture (500) ultimately, more than one means can be utilized when necessary. Adjuvant locking materials such as surgical adhesives and hardening agents that can be used with all other sutures (500) are among the examples for these means. Yet again more than one buckle (300) embodiment can be used in combination and/or consecutively. Furthermore, the buckle (300) may have moved and/or fixed edges as well as friction surfaces and/or tabs in order to prevent the suture (500) from sliding. Parts that are being used in the inventive stabilization system (1 ) can be roughened, tabbed or smoothed. Chemical, biological adhesives and/or hardeners can be used individually or in combination. Pleating, UV-irradiation, infrared irradiation or hot melting through energy transmission or with the methods of other irradiation means, convection, evaporation and conduction, throttling, hardening, bonding or point welding and other welding systems can be utilized.

In addition to the tensioning apparatus (700), basic hand tools that function under the principle of pliers, screwdrivers, clamps, wrenches, bolt/nut holders can also be used for the tensioning operation. Furthermore, in case of need, combining materials can be coated or covered with rubber, silicon, epoxy or suchlike materials in order to reduce and/or balance the point pressure.

Moreover, an angle bracket-crochet (the element that prevents the bone tissue from rupturing in case of excessive tensioning) like part can be prepared by using above mentioned or not mentioned materials and be used with the stabilization system (1 ) in order to ensure that the load imposed on edges and/or other weak points on assembled materials is carried safely.

Particularly in pediatric surgeries, since the skin and subcutaneous tissues are much thinner, and the bone growth is still ongoing, providing an ultrathin stabilization system (1 ) is crucial. Therefore, since the inventive stabilization system (1 ) can be also be used on the sternum, and because the skin is right on top of the osseous tissue, it has a slim structure that does not cause any discomfort to the patient and that cannot be felt from outside. The structure of the stabilization system (1 ) renders this system usability not only for the sternal closure but also for any type of medical use and in any other industrial fields that require the use of such a system. In the manufacturing of the parts that are being used in the inventive stabilization system (1 ) biocompatible raw materials that can remain in the human body for a long time can be used. The inventive stabilization system (1 ) can also be used for extracorporeal operations without featuring this particular characteristic.

The inventive stabilization system (1 ) can be used individually or in combination with custom-engineered and/or adapted systems comprising impellers, geared mechanisms, spring mechanism that can apply tensile force by means of rotating and/or moving linearly.

As it is shown in Figure 1 and Figure 2, as the tensioning apparatus (700) can be operated with manually, it can also be operated with various energy sources including motors, accumulators or batteries.

Claims

1. The stabilization system (1 ) that can be used in suturing, rejoining, securing, cerclage applications of all osseous and soft tissues in surgical operations characterized by comprising;

• locking element (100) which ensures that suture (500) remains immobilized and that prevents suture (500) from moving by means of applying force to the tension-adjusted suture (500) and which can be in one or more than one of the forms of screw (101 ), wedge (103), clamp screw (104), wedge clamp (105), clip screw (106), latch spring (107), ball (108), plate tab (109) and locking ring (110); tightener (200) that applies pressure towards the suture when it is tightened and that can be in one or more than one of the forms of plate (201 ), spring (203), clamp (205), slidable part (206), clip (208), latch (209) and hinged plate (210); suture channel (400) that provides assistance in tensioning of suture (500) and that allows suture (500) to go in and come out; buckle (300) that carries suture (500) which creates a line by means of surrounding or passing through the structure that is desired to be secured and that carries point of support (600) that allows for obtaining two units of force on buckle (300) when one unit of force is applied to suture (500) by means of points of support (600);

• suture (500) that has two ends as entry suture (501 ) and exit suture (502), that reaches to buckle (300) by means of being wound around osseous tissue and/or by means of being passed through osseous tissue, that can be passed through suture channels (400) in various combinations, and that allows the applicator to select various sequences based on ease of tensioning, safety of loosening;

• tensioning apparatus (700) having a palm grip (701 ) that allows the user to grip the apparatus; tensioning trigger (702) that rotates tensioning pulley (707) in the same direction with tensioning gear (705) by means of rotating tensioning gear (705) around its own shaft each time it is pulled with user's index finger; locking gear lower latch (703) and gear upper latch (704) that move freely on their own central shafts; and that contains suture socket (706) which provides the necessary gap and path for winding suture (500) around tensioning pulley (707) and that allows suture (500)to be tensioned.

2. Stabilization system (1) according to Claim 1 characterized by comprising;suture (500) that can be manufactured from elastoplastic material, that does not cause any damage to the material, that does not cause any trauma or damage to the tissue prior to, during or after the implementation and that does not cause any discomfort for the patient.

3. Stabilization system (1 ) according to Claim 1 characterized in that; suture (500) can be manufactured from a bioabsorbable material that can be absorbed by the human body in order to prevent suture (500) from hindering child development and growth in pediatric surgeries.

4. Stabilization system (1 ) according to Claim 1 or Claim 3 characterized in that; bioabsorbable suture (500) materials polydoxanone.

5. Stabilization system (1 ) according to Claim 1 or Claim 3 characterized in that; bioabsorbable suture (500) materials poliglecaprone.

6. Stabilization system (1 ) according to Claim 1 characterized by comprising; suture (500) that can be used as an adjuvant to locking element as chemical, biological adhesives and/or hardeners which can be utilized individually or in combination and that can be used individually or in combination with heating, UV-irradiation, infrared irradiation or hot melting through energy transmission or with the methods of other irradiation means, convection, evaporation and conduction, throttling, hardening, bonding or point welding and other welding systems.

7. Stabilization system (1 ) according to Claim 1 characterized by comprising; buckle (300) having movable and/or fixed edges as well as friction surfaces and/or tabs in order to prevent suture (500) from sliding.

8. Stabilization system (1 ) according to Claim 1 characterized by comprising; suture (500) that is in a structure which allows for using standard hand tools for tensioning operation.

9. Stabilization system (1 ) according to Claim 1 or Claim 7 characterized in that; standard hand tools can be one or more than one of pliers, screwdriver, clamp, wrench, bolt/nut holder.

10. Stabilization system (1 ) according to Claim 1 characterized in that; the structure allows using the stabilization system (1 ) with an angle bracket-crochet like part or extension in order to ensure that the load imposed on edges and/or other weak spots on assembled materials is carried safely.

11. Stabilization system (1 ) according to Claim 1 characterized in that; parts that are being used in stabilization system (1 ) may be manufactured from biocompatible raw materials that can remain in the human body for a long time.

12. Stabilization system (1 ) according to Claim 1 characterized by comprising; tensioning apparatus (700) that can also be operated with various energy sources including motors or accumulators and batteries.

13. The method of stabilization system (1 ) according to Claim 1 characterized by comprising the process steps of;

• tensioning suture (500) with tensioning apparatus (700) in a manner that a grip that is strong enough is provided by means of passing suture (500) through suture channels (400) located on buckle (300);

• ensuring that force created on buckle (300) is controlled with only half of the force through the point of support (600) that allows for obtaining two units of force on buckle (300) when one unit of force is applied to suture (500) by means of points of support (600);

• immobilizing suture (500) by tightening plate (201 ) by means of applying force to suture (500) through points of support (600) in a manner that loosening is prevented;

• moving tightener (200) that is in plate form towards buckle (300) with locking element (100) that is in the form of a screw;

• tightening suture (500) that remains in between plate (201 ) and buckle (300);

• locking stabilization system (1 ) by means of tightening screw (101 ) through moving it within the screw socket (202) located on the plate (201 ).

14. The method of stabilization system (1 ) according to Claim 1 characterized by comprising the process steps of;

• ensuring that force created on buckle (300) is controlled with only half the force through the point of support (600) that allows for obtaining two units of force on buckle (300) when one unit of force is applied to suture (500) by means of points of support (600);

• tightening suture (500) with tightener (200) that is in the form of spring (203) by means of applying a horizontal force to suture (500) and ensuring that it remains tensioned;

• providing assistance in immobilizing of suture (500) by means of applying force to suture (500) with spring (203) at points of support (600);

• locking stabilization system (1 ) by means of moving locking element (100) that is in the form of the wedge (103) within the wedge channel.

15. The method of stabilization system (1 ) according to Claim 1 characterized by comprising the process steps of;

• tightening suture (500) by means of applying pressure to suture (500) with tightener (200) that is in the form of clamp (205) and ensuring that it remains tensioned; • locking stabilization system (1 ) by means of moving locking element (100) that is in the form of clamp screw (104) within the channel positioned on clamp (205).

16. The method of stabilization system (1 ) according to Claim 1 characterized by comprising the process steps of;

• tightening suture (500) by means of applying pressure to suture (500) by moving tightener (206) that is in the form of the slidable part (206) within buckle (300) in a uniaxial manner and ensuring that suture (500) remains tensioned;

• ensuring that force created on buckle (300) is controlled with only half the force through point of support (600) that allows for obtaining two units of force on buckle (300) when one unit of force is applied to suture (500) by means of points of support (600) and providing assistance in immobilizing suture (500) by means of applying force to suture (500) with slidable part (206) at points of support (600);

• locking stabilization system (1 ) by means of moving locking element (100) that is in the form of wedge clamp (105.

17. The method of stabilization system (1 ) according to Claim 1 characterized by comprising the process steps of;

• ensuring that force created on buckle (300) is controlled with only half the force through the point of support (600) that allows for obtaining two units of force on buckle (300) when one unit of force is applied to suture (500) by means of points of support (600); • tightening suture (500) with tightener (200) that is in the form of clip (208) by means of applying pressure to suture (500) by moving it and ensuring that suture (500) remains tensioned;

• providing assistance in immobilizing of suture (500) by means of applying force to suture (500) with clip (208) at points of support (600);

• locking stabilization system (1 ) by means of moving locking element (100) that is in the form of clip screw (106).

18. The method of stabilization system (1 ) according to Claim 1 characterized by comprising the process steps of;

• tightening suture (500) by means of applying pressure to suture (500) by moving with the assistance of shaft with tightener (200) that is in the form of the latch (209) and ensuring that suture (500) remains tensioned;

• providing assistance in immobilizing of suture (500) by means of applying force to suture (500) with latch (209) at points of support (600);

• locking stabilization system (1 ) by means of moving locking element (100) that is in the form of latch spring (107).

19. The method of stabilization system (1 ) according to Claim 1 or Claim 18 characterized by comprising the process steps of;

• tensioning suture (500) with tensioning apparatus (700) in a manner that a grip that is strong enough is provided by means of passing suture (500) through suture channels (400) located on buckle (300); • ensuring that force created on buckle (300) is controlled with only half the force through the point of support (600) that allows for obtaining two units of force on buckle (300) when one unit of force is applied to suture (500) by means of points of support (600);

• locking stabilization system (1 ) by means of moving locking element (100) that is in the form of a ball (108) within the ball channel.

20. The method of stabilization system (1 ) according to Claim 1 characterized by comprising the process steps of;

• tensioning suture (500) by means of applying pressure to suture (500) by drawing tightener (200) that is in the form of the hinged plate (210) together with a hinge;

• providing assistance in immobilizing of suture (500) by means of applying force to suture (500) with a hinged plate (210) at points of support (600);

• locking stabilization system (1 ) by means of moving locking element (100) that is in the form of plate tab (109).

21. The method of stabilization system (1 ) according to Claim 1 characterized by comprising the process steps of;

• Ensuring that force created on buckle (300) is controlled with only half the force through the point of support (600) that allows for obtaining two units of force on buckle (300) when one unit of force is applied to suture (500) by means of points of support (600); • immobilizing suture (500) by means of applying force to suture (500) with locking ring (110) at points of support,

• locking stabilization system (1 ) by means of crushing locking element (100) that is in the form of locking ring (110) in a flat shape or in a shape having zigzag pattern.

22. Stabilization system according to Claim 1 or Claim 21 characterized in that; buckle (300) is of a structure that allows for using it in more than one and individual parts.

23. Stabilization system (1 ) according to Claim 1 or Claim 14 characterized by comprising: wedge (204) having the same function with spring (203) and that can be used instead of spring (203).

24. Stabilization system (1 ) according to Claim 1 or Claim 16 characterized by comprising: spring wedge (207) having spring channel that allows for moving spring and that can be used instead of wedge clamp (206).