RU2698443C1 - Locking ligature device for nodeless closure of wound surfaces and method of application - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions relates to medical equipment, specifically to surgical stapling instruments for nodeless stapling of tissues, and can be used when closing surface and deep wounds in humans and animals. Locking ligature device for nodeless closure of wound surfaces consists of bidirectional ligature body with sharpened shanks from both ends of ligature body, set of locks, including separate head and combined lock, as well as set of conductors with possibility of connection with shank ends of ligature. Reliefs of ligature body are made with inclination oriented in direction from shanks to centre of ligature body, on not sharpened shanks additionally notches are made, and combined lock consists of two separate heads connected inseparably to each other. Method for nodeless suturing of wound surfaces, which connects and retains wound edges with the help of a device containing a head, a ligature body and a shank, including insertion of a ligature body shank into the head and ligature fixation in the head. Above device is used, and to produce a suture, the body tissue is pierced with a conductor, into which a pointed shank of the bidirectional ligature body is inserted and jointly delivered through the wound edges, after which the conductor is removed.

EFFECT: use of inventions allows providing higher quality of application and fixation of sutures when performing superficial and deep surgical procedures for skin incision closure, muscle ruptures, as well as for surgical interventions on vessels and internal organs, for example, liver and pulmonary tissue, in patients.

7 cl, 21 dwg

Description

The invention relates to surgery, namely to surgical stapling instruments for knot-free tissue stitching, and can be used for suturing superficial and deep wounds in humans and animals.

Of great importance in the successful outcome of a surgical intervention is the ability to quickly and reliably impose a quality ligature in combination with atraumatic surrounding tissues. The search for new technical solutions for suturing in surgical practice remains an urgent need.

It is known (see RU 2417770, IPC АВВ 17/06) A ligature lock device for stitching a skin incision and / or body tissue wound and a knotless method for stitching a skin incision and / or body tissue wound. This work is of fundamental importance, since it opens up the possibility of knotless stitching of tissues using a unidirectional device made of surgical-grade materials consisting of a head end in the form of a head with a lock, a ligature body and its tail end. The head contains a through channel with a lock, which is designed to receive and subsequently advance the tail end and the ligature body until the lock is locked in the required position. The ligature body has a non-circular cross-section and one surface of the ligature body is smooth, and the opposite surface has reliefs formed by transverse protrusions and depressions that are oppositely oriented towards the head. The tail end is made pointed for ease of passage through stitched fabrics. A surgical needle may be attached to the tail end to enhance penetration into the stitched tissue. For suturing, one or more castle ligature devices are used. The tail end and the ligature body are passed through the edges of the bodily tissue defect, then inserted into the through channel of the head and fixed in the lock. Manipulations are repeated as many times as necessary, using the necessary number of devices, until they provide a knot-free stitching of the skin incision and / or body tissue wound. The known device effectively connects soft tissue without tying a knot. At the same time, the use of the device is ineffective when connecting dense organs and tissues, during surgical interventions, accompanied by compression of the vessels of the resected tissues, tying up large vessels. The known device, due to the sliding and displacement of tissues, is not able to provide accuracy and reliability of rapprochement and connection. The disadvantage is the inconvenience of suturing deep wounds and the existing difficulty in piercing tissues.

It is known (see Pat. 159168 Russian Federation, IPC А61В 17/06, 2015) A ligature locking device, which is supplemented with a locking ring of rectangular cross section with rounded corners to prevent displacement and sliding, on which one long side there are two rounded teeth parallel to the axis body ligatures. The locking ring is placed at the head of the device so that the teeth are on the inside of the ligature body and are directed towards the head. The experience of using a one-vector castle ligature device [I.G. Kiselev, 2016] with a different type carried through connected tissues is also known to introduce a pointed tail end. The tail end and ligature body are dragged through the stitched tissue and the injection needle is removed. Tissues or vessels are then circled to form a loop from the ligature body.

Despite the fact that the well-known one-vector castle ligature device provides prophylaxis of bleeding from resected large vessels during organ removal, it has the disadvantages of the known castle ligature device: the shank is difficult to insert into dense tissues (for example, skin), and the attachment of the shank to the surgical needle is unreliable and inefficient.

The objective of the invention is the expansion of the arsenal of surgical devices for closing wounds and improving the technology of their application.

The technical result from the use of the claimed device and method of its use is to improve the quality of the application and fixation of sutures when performing superficial and deep surgical procedures to close the skin incision, muscle breaks, as well as during surgical interventions on the vessels and internal organs, for example, the liver and pulmonary tissue in patients.

The technical result achieved by the group of inventions is to reduce the time spent on suturing wounds and blood vessels, improving the quality of the operation. The use of a group of inventions provides quality control of the stitched seam and uniform pressure on the connected tissue, since each fragment of the seam is independent and maintains a given tension. This allows for optimal matching of the edges of the wound and the formation of an even linear scar.

The specified technical result is achieved by the fact that the ligature lock device for knotless suturing of wound surfaces consists of a bidirectional ligature body with pointed shanks on both ends of the ligature body, a set of locks including a separate head and combined lock, as well as a set of conductors with the ability to connect with the body shanks ligatures, and the reliefs of the ligature body are made with a slope oriented in the direction from the shanks to the center of the ligature body, on the pointed tails The notches are additionally made notches, and the combination lock consists of two separate heads connected inseparably to each other.

In addition, the conductors are straight and curved, as well as hollow and solid.

In addition, the hollow conductors contain, located at the distal end, a cutting tip, beveled at an angle, and a V-shaped slot made at an angle to the axis of the conductor.

Also, solid conductors contain, located at the distal end, a cutting tip and a through hole for introducing a shank, which is made at an angle with respect to the axis of the conductor.

And finally, the pointed shank of the ligature body can be provided with both a cutting tip and a piercing shape.

What is new in the invention is that the ligature body is bi-directional with pointed shanks on both ends of the ligature body equally suitable for insertion into the fabric, and the slope of the ligature body reliefs, oriented in the direction from the shanks to the center of the ligature body, facilitates the smooth passage of the ligature body. New in the invention is the implementation of notches on the pointed shanks. New in the invention is a separate head and a combination lock of double heads capable of fixing a pair of ligatures. New in the invention is a set of conductors for the body of the ligature, contributes to the smooth conduct of the body of the ligature. New in the invention is the implementation of notches on the pointed shanks. New in the invention is a separate head and a combination lock of double heads capable of fixing a pair of ligatures. New in the invention is a set of conductors for holding the ligature body to the required depth in all types of stitched tissues in accordance with the anatomical size of the wound or sutured organ.

The claimed technical solution differs from the known ones in that the ligature device is bi-directional, with notches on the pointed shanks; the head is made in the form of a separate node, represented by a separate head, as well as two connected heads together; the device is provided with a set of conductors for different types of tissues that differ in density, as well as for wounds that differ in width and depth.

The inventive device is illustrated by drawings:

FIG. 1 - locking ligature device, bidirectional;

FIG. 2 - shank with a piercing tip, with notches;

FIG. 3 - shank with a cutting tip, with notches;

FIG. 4 - shank with a piercing tip, with reliefs;

FIG. 5 - shank with a cutting tip, with reliefs;

FIG. 6 - ligature locking device, unidirectional with a separate head;

FIG. 7 - combination lock;

FIG. 8 - straight hollow conductor;

FIG. 9 - curved hollow conductor;

FIG. 10 - straight conductor continuous;

FIG. 11 - solid curved conductor;

FIG. 12 - counter directional reliefs of the ligature body;

FIG. 13 - section of the head with the body of the ligature;

FIG. 14- the tip of the hollow conductors with a slot;

FIG. 15 - the tip of the conductors of direct solid;

FIG. 16 - the tip of the conductors of curved solid;

FIG. 17 - handle for conductors

FIG. 18 - connection of a straight hollow conductor with a shank;

FIG. 19 - connection of a curved continuous conductor with a shank;

FIG. 20 - suturing of a deep wound using bidirectional ligatures and combined locks;

FIG. 21 - suturing of a skin wound using unidirectional ligature and a separate head.

The ligature lock device for knotless suturing of wound surfaces consists of a ligature body 1 (Fig. 1) with two shanks 2,3 (Fig. 2-5), a set of locks in the form of a separate head 5 (Fig. 6) and a combination lock 6 (Fig. 7), a set of conductors (Fig. 8 - Fig. 11). The composition of the claimed device also includes a single-vector lock ligature device (Fig. 5).

The ligature body 1 (Fig. 1) has a smooth outer side, and the inner side adjacent to the tissue or vessel has transverse reliefs formed by protrusions and depressions, the inclination of which is oriented from the shanks to the center of the ligature 1 body (Fig. 12). The proposed element is bidirectional, because both ends are suitable for insertion into body tissue and this makes the device more universal, since it allows you to simultaneously bring together, hold the edges of the wound and perform compression along the depth of the wound. In the pointed shank, the shape of the tip can be pricking 2 (Fig. 2) or cutting 3 (Fig. 3) and notches 4 are made on the tip. The width of the ligature body can be 2-3 mm, 3.5-4 mm, 4.5- 5 mm, etc., up to 15 mm, and the length depends on the area of anatomical application. The piercing shank 2 is carried out on the ligature body with a width of more than 4 mm, and the ligature body up to 3 mm wide is provided with a cutting shank 3. In another embodiment of the shank, transverse reliefs are performed to the end of the shank (Fig. 4 and Fig. 5). The shank of the unidirectional locking ligature device is also performed (Fig. 5) in accordance with the above description: pricking or cutting, with notches on the tip, smooth or with reliefs. In the present invention, the body tissue is punctured not by shanks, but by conductors into which firmly held shanks are inserted. The presented options for performing shanks of the ligature body effectively solve this problem.

The set of locks includes a separate head 5 (Fig. 6) and a combination lock 6 (Fig. 7). The head 5 is carried out separately from the body of the ligature 1, and the combination lock 6 consists of two heads 5 connected inseparably to each other. Each head 5 contains a through channel 7 with a locking element inside, and the width of the channel corresponds to the width of the ligature body 1. A shank 2 or 3 of the ligature body is introduced into the through channel 7 (Fig. 13) and the lock does not interfere with the reception and subsequent movement of the ligature body inside the channel, because the direction of the locking elements (teeth) of the lock of each head corresponds to the direction of the reliefs of the body of the ligature 1. At the same time, the locking element of each head 5 prevents the reverse movement of the body of the ligature 1. The outer surface of each head 5 is shaped into a polyhedron in the form of a prism with a hexagonal base that does not injure tissue and promotes the rapid growth of tissue capsules. Elimination of right angles on the head allows dense encapsulation of the fastening fragment during fouling. And with subcutaneous use, there is no sensation of the appearance of a foreign body. In addition, the beveled surface of the head in front of the through channel 7 allows you to effortlessly achieve maximum compression of the soft tissues (vessels) without additional devices, for example, rings from patent No. 159168. The proposed external shape of the head is performed for a unidirectional castle ligature device (Fig. 6). In addition, any other external geometric shape of the head is allowed provided that it meets the requirements for non-injuries.

The surgeon has the ability to perform superficial and deep surgical procedures, using various options for nodeless stitching of tissues using the inventive ligature, a combination lock and a separate head, as well as the well-known castle ligature device.

A set of conductors, which are part of the claimed device, expand the range of effective use of the device from closing wounds of soft tissues (liver, lung tissue) to connecting dense organs and tissues - sternum, fascia, tendons, skin. Conductors reduce the effort when piercing biological tissue and can, depending on the task, be carried out at different depths of takna and in a different plane without restrictions, including intradermal, subcutaneous, transmuscular, as well as passing through any thickness of parenchymal organs. Conductors can be made of any metal for medical purposes. In accordance with embodiments, the cylindrical conductors can have a different shape, including a straight line (Fig. 8, Fig. 10) and curved with different curvatures (Figs. 9-11). All conductors (straight and curved) are both hollow (Fig. 8.9) and solid (Fig. 10.11). The length of the conductor corresponds to the anatomical size of the wound or sutured organ and can be in the range of 50 mm ÷ 300 mm or more. When choosing a conductor, the diameter of the conductor is correlated with the width of the ligature body. For example:

- for the ligature body with a width of 2-3 mm, a conductor with a diameter of 2.2-3 mm is used;

- for the ligature body with a width of 3.5-4 mm, a conductor with a diameter of 3-3.5 mm is used;

- for the ligature body with a width of 4.5-5 mm - the diameter of the conductor is 4-4.5 mm;

- for a ligature body with a width of 6-8 mm - the diameter of the conductor is 6 mm;

- for a ligature body of 10-12 mm, the diameter of the conductor is 6-8 mm.

The straight hollow conductor 8 (Fig. 8) in the form of a rod has at its distal end a cutting tip 13, beveled at an angle, and also a V-shaped slot 14, made at an angle to the axis of the conductor 8 (Fig. 12). On the slot, on the side oriented towards the tip of the conductor, micro teeth can be made. Slot 14 is designed to introduce the shank of the ligature body into the conductor. The inclined shape of the slot 14 simplifies the insertion of the shank into the conductor, and the micro-teeth, in combination with the shape of the shank and the notches, firmly hold the shank in the conductor.

The curved hollow conductor 9 (Fig. 9) also has a cutting beveled tip 13 and a V-shaped slot 14 (Fig. 12). Such a conductor effectively punctures soft tissues. The dimensions of the slot, as well as the dimensions of the conductors, are correlated with the dimensions of the ligature body.

The straight conductor 12 continuous (FIG. 10) has a cutting tip 15 located at the distal end and a through hole 16 (FIG. 15). The through hole 16 is made at an angle relative to the axis of the conductor and is intended to introduce a shank 2 or 3 of the ligature body 1. The hole 16 may have a round or rectangular shape.

The curved solid conductor 11 (Fig. 11) has a cutting tip 16 located at the distal end and a through hole 16 (Fig. 16). The through hole 16 is made at an angle relative to the axis of the conductor and is intended to introduce a shank 2 or 3 of the ligature body 1. The hole 16 may have a round or rectangular shape. The dimensions of the holes correspond to the dimensions of the ligature body.

Known knotless method of stitching a skin incision and / or wounds of bodily tissue (see RU 2417770, IPC AB 17/06, 2011). For stitching a skin incision and / or wound of body tissue, the required number of known devices is used. The tail end and body of the ligature are first passed through the edges of the defect in body tissue, then through the through channel in the head. A loop is formed and fixed, fixing the ligature of the seam. Manipulations are repeated the required number of times, and the free part of the ligature body is cut off. The disadvantage of this method is the difficulty in suturing deep extensive wounds, as well as the inefficiency of piercing the edges of the wound with a shank.

Object of the invention A method for knotless suturing of wound surfaces is to simplify the surgical procedure by using a ligature device to bring together the edges of the wounds, including extensive and deep wounds.

The technical result from the use of the proposed method is to reduce irrational manipulations, increase the speed of suturing during surgical interventions on tissues and organs with different spatial geometry of the defect and at any depth. The technical result is also to increase the reliability and accuracy when suturing, which allows for complex closures.

The claimed technical result is achieved by the fact that for knotless suturing of wound surfaces using the device according to p. 1-6. The method of application differs from the known methods of knotless suturing of wound surfaces with features that are embedded in the design of the device according to p. 1-6. To make a seam, the body tissue is punctured by the conductor, after which, the ligature body shank is inserted into the conductor, which are jointly passed through the edges of the wound, after which the conductor is removed.

Example 1

To stitch an extensive wound, a conductor is selected from a set of conductors. A straight hollow conductor 8 pierces the tissue, leads around the wound (Fig. 20), leads to the tip of the conductor, and the pointed shank 2 of the bidirectional ligature body 1 is inserted into the slot 14. Then the conductor together with the ligature body is drawn back, the shank is released from the conductor and, in the desired position, the shank is introduced into the through channel 7 of the head of the combined lock 6. The surgeon simultaneously brings together, holds the edges of the wound and performs compression along the depth of the wound. The second shank of the ligature body is introduced into the second free through channel of the head of the combination lock 5. Dosed movement (reshooting) of the ligature body in the head allows the surgeon to calculate the necessary pressure on the organ and stop applying force when the bleeding from the wound of the injured organ stops, making the necessary pause, thereby saving the possibility of normal blood supply to the squeezed area and to avoid unnecessary manipulations. Unlike suturing with threads, where the desire to stop bleeding from a wound subconsciously pushes the surgeon to an even greater effort due to the fact that the tied knot of the thread is not controlled. In the case of an unsatisfactory result, the thread, as a rule, is cut off and the procedure for suturing with a thread starts again.

Example 2

A straight continuous conductor 12 with a unidirectional locking ligature device installed in it (Fig. 5) cleaves the edges of the skin wound, removes the conductor and inserts the shank into a separate head 5 (Fig. 21). When suturing using the claimed device, a uniform pressure of suture material is created on the connected tissues, since the specified tension is maintained. This allows you to provide the necessary hemostatic effect, the optimal comparison of the edges of the wound and the formation of an even linear scar.

The technique of suturing different tissues using conductors has been tested on more than 100 dogs for suturing skin wounds of various sizes, depths and configurations, with varying degrees of their infection (clean, purulent). When closing the muscle layers of surgical wounds on the abdominal wall, during surgical interventions on the chest in case of extensive trauma to it with the phenomena of pneumothorax and fracture of the ribs, as well as with gastropexy if it is necessary to keep the stomach near the muscle wall.

The author has presented and described preferred embodiments of the invention, but other modifications are possible that do not go beyond the essence and claims. Therefore, the description serves solely the purpose of illustrating the invention and in no way limit it.

Information sources

1. Pat.2417770 Russian Federation, IPC 6 A61B 17/06. Ligature locking device for stitching a skin incision and / or wound of body tissue and a knotless method for stitching a skin incision and / or wound of body tissue / Krivokorytov A.L. (RU), Krivokorytov L.A.

(RU); Applicant and patent holder A. Krivokorytov A. (RU), Krivokorytov L.A. - No. 2009105136/14; declared 02/13/2009; publ. 08/20/2010 Bull.№23.

2. Pat. 159168 Russian Federation, IPC 6 АВВ 17/06. Ligature locking device / Kiselev I.G (RU); applicant and patentee Kiselev I.G. - No. 2015141721/14; declared 09/30/2015; publ. 02/10/2016 Bull. Number 4.

3. Kiselev I.G. APPLICATION OF SINGLE-VECTOR LOCKED LIGATURE DEVICES (OSLU) WITH A TITANIUM COATING IN VETERINARIUM // International Journal of Applied and Basic Research. - 2016. - No. 12-9. - S. 1644-1648.

Claims (7)

1. Ligature lock device for suturing wound surfaces without knots, characterized in that the device consists of a bidirectional ligature body with pointed shanks at both ends of the ligature body, a set of locks including a separate head and combined lock, as well as a set of conductors with the ability to connect with body shanks ligatures, and the reliefs of the ligature body are made with a slope oriented in the direction from the shanks to the center of the ligature body, on the pointed shanks additionally Execute the notches, and a combination lock consists of two separate heads are connected integrally to each other. 2. The device according to claim 1, characterized in that the conductors are straight and curved, as well as hollow and solid. 3. The device according to p. 2, characterized in that the hollow conductors contain located at the distal end of the cutting tip, beveled at an angle, and a V-shaped slot made at an angle to the axis of the conductor. 4. The device according to claim 2, characterized in that the solid conductors contain a cutting tip located at the distal end and a through hole for introducing the shank, which is made at an angle with respect to the axis of the conductor. 5. The device according to claim 1, characterized in that the pointed shank of the ligature body is provided with a cutting tip shape, which is performed on the ligature body with a width of up to 3 mm. 6. The device according to claim 1, characterized in that the pointed shank of the ligature body has a piercing tip shape, which is performed on the ligature body with a width of more than 4 mm. 7. A method for knotless suturing of wound surfaces that connects and keeps the wound edges closed using a device containing a head, a ligature body and a shank, including introducing a ligature body shank into the head and fixing the ligature in the head, characterized in that the device according to claims. 1-6 and to make a seam, the body tissue is pierced with a conductor, into which the pointed shank of the bidirectional ligature body is inserted and jointly passed through the edges of the wound, after which the conductor is removed.

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