RU2641368C1 - Method for inguinal hernia treatment - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: in the medial part of the patient's inguinal canal lying on the back, a polymerizable mixture consisting of three solutions A, B and C is introduced by injection through the needle. Solution A is a solution of a copolymer of acrylamide and hydroxysuccinimide ester of acrylic acid. Solution B is a solution of 1,4-butanediamine and succinic acid. Solution C is a solution of sodium hydrogencarbonate. The molar ratio of acrylamide and hydroxysuccinimide ester of acrylic acid in the copolymer is selected in the range of 9:1 to 7:3, the molar ratio of 1,4-butanediamine to succinic acid in solution B is selected in the range of 4:1 to 1:1. The concentration of solution A was selected from the mass concentration of the copolymer in solution A in the range 21.8-26.3 g/l. The concentration of solution B is: for 1,4-butanediamine - about 22.0 g/l, for succinic acid - in the range of 7.4-29.5 g/l. The concentration of solution C is in the range of 0.6-1.1 mol/l. The ratio of the quantity of solutions A and B is chosen so that the molar ratio of hydroxysuccinimide ester of acrylic acid in the copolymer and 1,4-butanediamine does not exceed 2:1. The ratio of the quantity of solutions B and C is selected from the condition that the molar ratio of sodium hydrogencarbonate and succinic acid is not less than 2:1. The mixture is prepared by successively mixing solutions A and B and then solution C. Then, the prepared mixture is injected until the inguinal canal is filled and the patient is left in the indicated position until the polymerization of the mixture introduced into the inguinal channel is completed.

EFFECT: invention allows minimally invasive elimination of hernial protrusion, reliable closure of hernial gates, and prevention of recurrent inguinal hernia.

7 cl, 9 dwg

Description

FIELD OF TECHNOLOGY

The invention relates to medicine, namely to general surgery, in particular to methods for treating inguinal hernias, and can be used to treat relieved and unstressed inguinal hernias.

BACKGROUND

For the treatment of inguinal hernias, various methods are used to strengthen the posterior wall of the inguinal canal, among which are:

1) a method in which the posterior wall of the inguinal canal is strengthened by suturing the lower edge of the internal oblique muscle and the transverse muscle to the inguinal ligament. This method involves the creation of tension stitched fabrics;

2) a method in which the posterior wall of the inguinal canal is strengthened by applying a mesh prosthesis (without tensioning the tissues). This method is known under the name of its author, Liechtenstein. Various modifications of this method are known, mainly depending on the location of the mesh prosthesis (above the inguinal canal, under the inguinal canal in the preperitoneal space, in the peritoneal cavity).

Both methods are very traumatic, since they involve the incision of the skin, subcutaneous tissue, the anterior wall of the inguinal canal and its contents. Such operations require general anesthesia, which has its complications and contraindications. All this significantly affects the duration of the postoperative recovery period, as well as the cost of the entire treatment.

Currently, one of the priority areas in surgery is to minimize the amount of surgical trauma due to the active introduction of minimally invasive methods of surgical treatment. This can significantly reduce the patient’s hospital stay. In this regard, as well as the requirements for cosmetic results of surgery, recently proposed new minimally invasive methods of surgical treatment of hernias. They exclude the classic incision and are performed using laparoscopy in the inguinal region with open access. Two types of such operations are known, described in [Current treatment concepts for groin hernia - Antoniou SA1, Pointner R, Granderath FA. Langenbecks Arch Surg. 2014 Jun; 399 (5): 553-8. doi: 10.1007 / s00423-014-1212-8. Epub 2014 May 14]:

1) TAPP (trans abdominal pre-peritoneal repair), in which the mesh is installed in the peritoneal space through the peritoneal incision from the side of the peritoneal cavity;

2) TEP (totally extra-peritoneal repair), in which the mesh is installed in the peritoneal space without opening the peritoneal cavity.

Although these methods are less traumatic than the previous two, they require the use of laparoscopic techniques and general anesthesia. At the same time, although to a lesser extent, a noticeable amount of surgical trauma and, accordingly, a longer recovery time after surgery and the cost of treatment are retained.

US 2010/0137890 describes a surgically implantable fibrous mesh and a method for its implantation into the patient’s internal cavity, in particular for the treatment of hernias. The mesh has a laminar extracellular structure, similar to a matrix, contains a first layer characterized by porosity that promotes the ingrowth of the patient’s tissue in the first layer, and a substantially non-porous second layer. The first layer is able to “stick” to the wall of the cavity that needs to be repaired, so that the wall tissue penetrates into it, while the second layer is not adhesive and does not injure the patient’s internal organs and gland. The first layer is made of biodegradable material, and tissues grow into the second layer and, therefore, it becomes part of the cavity wall.

This method also requires the use of laparoscopic techniques and general anesthesia.

US 2014/0187661 describes a method for treating inguinal hernias in which an implant is formed that closes the hernia gate. The implant is formed from a composition (mixture) consisting of telechelate macromers and a photoinitiator. The macromer contains (meth) acrylic end groups and contains a base that is joined by urethane, ester or anhydride bonds to (meth) acrylic groups. The mixture can be given a specific shape at a temperature of 37 ° C, and it is able to go from liquid to solid when irradiated with low-intensity light. When irradiated with light, the mixture acquires the desired physicochemical properties - it hardens and turns into an elastic body. The mixture can be injected directly in the form of a viscous fluid or paste in the area of the hernia through a small incision in the mucous membrane of the abdominal cavity.

This method is less traumatic than the above. Nevertheless, it involves performing a section of the abdominal mucosa, as well as the use of additional special equipment to irradiate the prepolymer mixture with light in order to start the polymerization process.

US 2005/0129733 describes surgical glue and a method for its use in the treatment of abdominal hernias. It is proposed to use liquid monomer as an adhesive, which can be introduced into the patient and which forms a solid hydrogel during in situ polymerization upon contact with body tissue. The process of forming an implant or coating involves polymerizing and stitching the adhesive with surrounding tissues. The described liquid adhesives contain a polyester polyol rich in isocyanate and a low molecular weight polyisocyanate. Preferred adhesives further include polyhydroxy compounds, such as water, or polyester polyols, so that swelling can be controlled and adhesion formation can be minimized. During treatment, the hernia is first set back, and then by laparoscopy, for example, through a patient’s navel, a catheter is inserted into the inguinal canal, through which a liquid adhesive - prepolymer is introduced. Upon contact with the tissue, the liquid prepolymer adsorbs tissue fluid and polymerizes with tissue proteins. The process ends with the formation of an elastic, associated with the surrounding tissue elastomeric plug, preventing the loss of hernia.

This method is quite simple to use, but involves the use of laparoscopic techniques, which significantly increases the total cost of the procedure and inevitably increases the amount of surgical injury and recovery time after surgery.

The problem to which the claimed invention is directed is to create a minimally invasive, laparoscopy-free method for treating inguinal hernias, based on the formation of an “in situ” polymer implant that reliably closes the hernial portal and eliminates hernial protrusion, as well as prevention of recurrence of inguinal hernia.

SUMMARY OF THE INVENTION

The essence of the claimed invention is associated with the formation directly in the inguinal canal of a polymer gel-like implant that is formed "in situ" from a special mixture capable of polymerization, introduced in liquid form into the inguinal canal by injection through a needle.

The claimed invention discloses a method of treating inguinal hernias, in which a polymerizable mixture consisting of three solutions A, B and C is introduced through the medial part of the inguinal canal into the inguinal canal of a patient lying on his back, the following are used:

solution A - a solution of a copolymer of acrylamide and hydroxysuccinimide ester of acrylic acid;

solution B - a solution of 1,4-butanediamine and succinic acid;

solution C - sodium bicarbonate solution.

The molar ratio of the units of acrylamide and hydroxysuccinimide ester of acrylic acid in the copolymer is selected in the range from 9: 1 to 7: 3, the molar ratio of 1,4-butanediamine and succinic acid in solution B is selected in the range from 4: 1 to 1: 1.

As a solvent of the above solutions used physiological saline, and:

the concentration of solution A is selected from the concentration of functional groups responsible for the gelation process in the range of 0.03-0.08 mol / l, which corresponds to the mass concentration of the copolymer in the solution in the range of 21.8-26.3 g / l;

the concentration of solution B is: for 1,4-butanediamine about 0.25 mol / l (or mass concentration about 22.0 g / l); succinic acid in the range of 0.06-0.25 mol / l, which corresponds to the mass concentration of succinic acid in solution in the range (7.4-29.5 g / l);

the concentration of solution C is in the range of 0.6-1.1 mol / L.

The ratio of the number of solutions A and B is selected from the condition that the molar ratio of hydroxysuccinimide ester of acrylic acid in the copolymer and 1,4-butanediamine does not exceed 2: 1, and the ratio of the number of solutions B and C is selected from the condition that the molar ratio of sodium bicarbonate and succinic acid not less than 2: 1.

The specified mixture is prepared by sequentially mixing solutions A and B, and then solution C, after which the prepared mixture is injected through a needle until the inguinal canal is filled, and the patient is left in this position until the polymerization process of the mixture introduced into the inguinal canal is completed.

As a result, the following processes occur. After adding solution C to mixed solutions A and B, the release of free amino groups begins, which in turn begin to interact with the active succinimide groups of the copolymer with the formation of intermolecular bridges and the formation of an intermolecular network - the basis of the future gel. The polymer base of the gel — the mentioned copolymer in solution A — is water-soluble, non-toxic, and capable of a quick crosslinking reaction (the process takes about 5-15 minutes) with the formation of intermolecular bridges and gel formation. As a crosslinker, 1,4-butanediamine was selected: the substance is non-toxic, capable of producing a homogeneous solution of a small molecular weight with a polymer base and having two functional groups, which makes it possible to crosslink the copolymer molecule at both ends. In the process of crosslinking, a gel of the required degree of hardness is formed, as well as low molecular weight substances - succinic acid and N-hydroxyscinimide, which is gradually hydrolyzed to succinic acid and hydroxylamine, which are harmless in the amounts used.

The required mechanical properties of the forming polymer are ensured, in particular, due to the selected crosslinker. For example, the use of 1,6-hexanediamine as a crosslinker leads to a decrease in the stiffness of the forming gel.

The indicated ratio of components in solution A also affects the result. The minimum concentration of the succinimide component is due to the minimum degree of crosslinking at which a gel of a sufficient degree of rigidity would be obtained. The maximum concentration of the succinimide component is due to the solubility of the copolymer in aqueous media (physiological saline); with an increase in the proportion of succinimide groups, the solubility of the copolymer decreases markedly.

The indicated concentration of solution A (mass concentration of copolymer) is due to the required viscosity of the copolymer solution, which, on the one hand, should be sufficient to achieve the highest possible concentration of active functional succinimide groups in the solution, and on the other hand, should not exceed values that would not allow work with this solution, that is, inject it into the body by injection without visible effort.

The indicated concentration of solution B and the ratio of its components makes it possible to vary the time of formation of the final product - the gel: the higher the concentration of succinic acid, the more time the resulting mixture remains fluid, which gives more time for manipulation. The maximum concentration of succinic acid in solution B (component ratio 1: 1) is due to the amount of 1,4-butanediamine necessary for the crosslinking reaction, on the one hand, and on the other hand, the amount of water (physiological solution in the system). For gel formation of a sufficient degree of rigidity necessary to maintain the shape of the resulting implant and to withstand the applied load from the abdominal cavity, the amount of water (physiological saline) in the system should be minimized.

The maximum concentration of solution C is due to the limiting solubility of sodium bicarbonate in aqueous media. The minimum concentration of solution C is determined by the amount of sodium bicarbonate required to start the crosslinking reaction, on the one hand, and on the other hand, by the amount of water (physiological saline) in the system. For gel formation of a sufficient degree of rigidity necessary to maintain the shape of the resulting implant and to withstand the applied load from the side of the abdominal cavity, the amount of saline in the system should be minimized.

The indicated quantitative ratio of solutions A and B (based on the molar ratio of hydroxysuccinimide ester of acrylic acid in the copolymer and 1,4-butanediamine) allows to obtain a network structure during the polymerization of the mixture, where each diamine molecule on both sides is linked to the corresponding group of the copolymer, exceeding the specified value leads to a drop in the strength properties of the resulting gel.

The indicated ratio of the components of solutions B and C was chosen so that the molar ratio of sodium bicarbonate and succinic acid was at least 2: 1, which allows activation of all amino groups in the solution for their interaction with the active succinimide groups of the copolymer.

The indicated sequence of preparation of the mixture from solutions A, B and C is also important to achieve the result. Failure to comply with the sequence of preparation of the mixture, for example, in the case of adding solution C to solution A, can lead to the inability to form an intermolecular network and, as a consequence, the impossibility of gel formation. Solution A is the most viscous (least fluid) component, so other components of the resulting mixture are added to solution A, and not vice versa. By adding solution B to solution A and mixing them thoroughly, the crosslinking agent — 1,4-butanediamine is evenly distributed throughout the volume of the mixture even before the polymerization (crosslinking) reaction begins, since the crosslinking agent is blocked by succinic acid (it is not in the form of pure amine in solution B) , and in the form of its succinic salt). After obtaining a homogeneous mixture of solution A and solution B (which is visually controlled), solution C containing soda is added to it and quickly mixed.

After mixing all the solutions, the gelation process begins. Soda neutralizes succinic acid, with the release of 1,4-butanediamine from its salt and the polymerization reaction begins. As a result of the reaction of the amino group of the crosslinker and the succinimide group of the copolymer, a covalent (amide) bond is formed between the crosslinker molecule and the copolymer molecule. In this case, N-hydroxysuccinimide is released into the environment. A similar reaction of the second amino group of the crosslinker leads to the formation of a bridge between the two molecules of the copolymer. Repeated repetition of such reactions leads to the formation of a continuous network of covalent bonds, uniting the entire volume of the mixture, the gel formation process is ongoing.

Gelation mainly occurs in the inguinal canal, where the resulting mixture is injected with a syringe. The injected mixture fills all the free space of the inguinal canal, displacing from it - due to hydraulic pressure and gravity, since the patient lies on his back - a hernial sac. Since the succinimide groups of the copolymer are reactive with respect to any amino groups, including those that belong to the protein molecules of the surrounding tissues, covalent crosslinking of the gel with the host tissue occurs in the area of contact of the mixture with the tissues. This ensures its good adhesion to the walls of the inguinal canal. As a result, the forming polymer adheres firmly to the walls of the inguinal canal, as a result of which an implant is formed - a mechanical obstacle for the hernia sac to again exit through the hernia gate.

Thus, in the implementation of the method in accordance with the invention provides a minimally invasive treatment of inguinal hernias without the use of laparoscopy, ensuring the elimination of hernial protrusion and the prevention of recurrence of inguinal hernia.

In the method, it is preferable to introduce the mixture into the inguinal canal through its external opening or through its front wall. In this case, the injected mixture enters the inguinal canal by the shortest, safest and easiest way from an anatomical point of view.

To better fill the inguinal canal with the mixture during its administration, it is preferable to advance the needle from the substantially external inguinal ring to the substantially transverse fascia. In this case, the injected mixture hydraulically pushes the spermatic cord and further advances the tip of the needle to the desired area. In addition, the introduction of the mixture allows you to perform a kind of hydraulic dissection of the various layers, in particular to separate the transverse fascia from the peritoneum.

To increase the reliability of closing the inguinal portal in the case of a direct inguinal hernia after filling the inguinal canal with the mixture, they additionally pass the needle behind the transverse fascia in the area of the medial inguinal fossa and enter the mixture into the preperitoneal tissue. In this case, a kind of “patch” is created in the preperitoneal tissue. Thus, the back wall of the inguinal canal is additionally strengthened in the projection of the hernial portal. As a result, after the completion of the polymerization of the injected mixture, the connection of the main part of the implant in the inguinal canal with the above part in the preperitoneal tissue forms a kind of “cufflink”. It also contributes to a more reliable fixation of the implant.

For the same purpose, in the case of an oblique inguinal hernia, after filling the inguinal canal with the mixture, they additionally pass a needle behind the transverse fascia in the lateral inguinal fossa and the mixture is introduced into the preperitoneal tissue. In this case, the deep inguinal ring narrows and an obstacle is created for the hernial sac from the abdominal cavity to enter the spermatic cord through the lateral inguinal fossa.

In the method, the introduction of the mixture into the inguinal canal of the patient is preferably carried out under ultrasound control. In this case, a clear visualization of the needle tip is carried out, which contributes to its safe, accurate and controlled progress.

When implementing the method, the introduction of the mixture into the inguinal canal of the patient can be carried out under local anesthesia, given that the mixture is administered by injection.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is illustrated by the drawings of FIG. 1-9, which schematically shows a horizontal section of the right inguinal canal at the level of the medial half of the inguinal ligament and which illustrate the stages of the implementation of the proposed method in cases of various types of inguinal hernia, while:

in FIG. 1 shows the condition of the inguinal canal without a hernia;

in FIG. 2 - the same with a direct inguinal hernia;

in FIG. 3 - the same with oblique inguinal hernia;

in FIG. 4-6 show the stages of treatment of a direct inguinal hernia in accordance with the present invention, wherein:

in FIG. 4 shows the initial stage of introducing the mixture into the inguinal canal;

in FIG. 5 shows the stage of reduction of the hernia under the action of the hydraulic pressure of the mixture filling the space of the inguinal canal;

in FIG. 6 shows the stage when the needle is advanced beyond the transverse fascia and the mixture is introduced into the preperitoneal fiber;

in FIG. 7-9 show the stages of treatment of oblique inguinal hernia in accordance with the present invention, with:

in FIG. 7 shows the initial stage of introducing the mixture into the inguinal canal;

in FIG. 8 shows the stage of reduction of the hernia under the action of the hydraulic pressure of the mixture filling the space of the inguinal canal;

in FIG. 9 shows the stage when the needle is advanced beyond the transverse fascia and the mixture is introduced into the preperitoneal fiber.

DETAILED DESCRIPTION OF THE INVENTION

In FIG. 1 schematically shows a horizontal section of the right inguinal canal at the level of the medial half of the inguinal ligament in a healthy condition without a hernia. Moreover, in FIG. 1 shows: inguinal canal 1 (medial part), internal seminal fascia 2, spermatic cord 3, parietal peritoneum 4, preperitoneal fiber 5, transverse fascia 6, internal oblique and transverse muscles 7 of the abdomen, aponeurosis 8 of the external oblique muscle of the abdomen. The inguinal canal 1 is limited by the transverse fascia 6 and aponeurosis 8 of the external oblique muscle of the abdomen. Also in FIG. 1 shows the medial inguinal fossa 9 (otherwise, the hernial portal for direct inguinal hernia) and the lateral inguinal fossa 10 (otherwise, the hernial portal for oblique inguinal hernia), as well as the medial umbilical cord 11 and the lower epigastric artery 12 and vein 13. Arrows 14 and 15 shows the direction of intra-abdominal pressure in the medial inguinal fossa 9 and lateral inguinal fossa 10, respectively.

In FIG. 2 shows the state of the inguinal canal 1 with a direct inguinal hernia. It is seen that in the area of the medial inguinal fossa 9 under the influence of intra-abdominal pressure (shown by arrow 14), the hernia (hernial sac) 16 was protruded into the space of the inguinal canal 1.

Similarly, in FIG. 3 shows the condition of the inguinal canal 1 with oblique inguinal hernia. It is seen that in the area of the lateral inguinal fossa 10 under the influence of intra-abdominal pressure (shown by arrow 15), a hernia (hernial sac) 17, localized in the spermatic cord 3, was protruded into the space of the inguinal canal 1.

The inventive method can be carried out as follows.

Before starting the procedure, the patient takes a horizontal position, which contributes to the self-adjustment of the hernia in the abdominal cavity or facilitates its reduction. After treatment of the surgical field with an antiseptic solution and its limitations, an anesthesiological aid is performed, in particular, endotracheal anesthesia, regional anesthesia, sedation, and local anesthesia are possible. In the General case, for the implementation of the method there is no need to perform general anesthesia. It is sufficient for the patient to administer an intravenous sedative and achieve shallow sedation. Local administration of anesthetic helps to avoid possible discomfort during the procedure.

Mixture preparation

To prepare the mixture, the starting components are taken in the following amount based on 1 ml of the resulting mixture:

a copolymer of acrylamide and hydroxysuccinimide ester of acrylic acid (with the number of units of hydroxysuccinimide ester of acrylic acid from 10 to 30 mol.%) - 100 mg;

saline - 400 μl;

a solution of 1,4-butanediamine and succinic acid (concentration 0.25 mol / l) - 100 μl;

sodium bicarbonate solution (concentration 0.6 mol / l) - 200 μl.

To implement the method in accordance with the invention, it is necessary to prepare the mixture in an amount sufficient to fill the inguinal canal, from about 10 to 20 ml, depending on the age, gender, type of physique of the patient.

The copolymer of acrylamide and hydroxysuccinimide ester of acrylic acid is a white hygroscopic powder that must be stored in dry conditions, and solution A should be prepared immediately before use. Solution A retains the ability to gel for about half an hour, then the number of reactive groups of the copolymer begins to gradually decrease. The longer the solution A was stored, the less hard the gel could ultimately be obtained, and about 12 hours after the preparation of solution A, gel formation became impossible.

Solution B can be prepared in advance by dissolving the required amount of 1,4-butanediamine and succinic acid in the desired volume of saline. The prepared solution B can be stored (preferably in the refrigerator and sterilized) for a rather long time - about several months.

Solution C can also be prepared in advance by dissolving the required amount of sodium bicarbonate in the desired volume of saline. The prepared solution C can be stored arbitrarily for a long time in a closed container.

Solution A is prepared immediately before use by dissolving a portion of a copolymer of acrylamide and hydroxysuccinimide ester of acrylic acid in physiological saline. This can be done in a transparent glass or plastic vessel, where the dry copolymer is first placed, then physiological saline and dissolve for several minutes, stirring the mixture with a stick or spatula to a visually homogeneous state - a clear, viscous solution without lumps.

After that, solution B is added to solution A, thoroughly mixed to a homogeneous state, and then solution C is added and mixed again to a homogeneous state. The mixture thus obtained is drawn into a syringe.

The resulting mixture remains in a liquid state for about 5 minutes. In this case, the viscosity of the mixture is such that its passage from the syringe, for example, through a 21G needle (on the Gage scale) does not meet noticeable resistance, therefore the contents of the syringe (approximately 20 ml) can be squeezed out of it within a few seconds.

The introduction of the mixture into the inguinal canal in the case of a direct inguinal hernia (Fig. 4-6) is as follows. Based on the visible and / or palpable external bone contours, folds, places of resistance and compliance during palpation, it is possible to determine the external inguinal ring, spermatic cord and the course of the inguinal canal. The needle 20 (see Fig. 4) is inserted through the skin into the medial part of the inguinal canal 1 in the region of the external inguinal ring, through which the spermatic cord 3. The use of ultrasound control provides a more accurate visualization of the tip of the needle 20 and allows you to monitor its progress in the inguinal channel 1. The mixture 22 is first introduced into the medial part of the inguinal canal 1 so that it is filled in the area of the lateral inguinal fossa 9. The mixture 22 introduced through the needle 20 pushes the spermatic cord 3 to the side (in Fig. 4 - up) and thus creates b zopasnoe space for further advancement of the needle 20 into the inguinal canal 1. Smooth and simultaneous administration of a mixture of 22 and advancement of the needle tip 20 is an important aspect in the implementation of the method according to the invention. The introduction of the mixture 22 is carried out until it fills the inguinal canal 1 (see Fig. 5), which leads to an obstacle to the hernia 16. Additionally, the needle 20 can be advanced through the transverse fascia 6 into the preperitoneal tissue 5 in the region of the medial inguinal fossa 9, where the introduction mixture 22 can be continued (see Fig. 6).

As a result of filling the inguinal canal 1 with the mixture 22 (see Fig. 5), the hernial protrusion is mechanically eliminated by displacing the hernial sac 16 from the cavity of the inguinal canal 1. The polymer formed from the mixture 22 is firmly bound to the tissues of the walls of the hernial canal 1, completely filling the volume of the hernial canal 1 and securely closing the hernia gate.

As described in the section "Disclosure of the invention", after mixing all the solutions, the gelation process begins. Sodium bicarbonate neutralizes succinic acid, with the release of 1,4-butanediamine from its salt and the polymerization reaction begins. As a result of the reaction of the amino group of 1,4-butanediamine (crosslinker) and the succinimide group of the copolymer, a covalent (amide) bond is formed between the crosslinker molecule and the copolymer molecule. In this case, N-hydroxysuccinimide is released into the environment. A similar reaction of the second amino group of the crosslinker leads to the formation of a bridge between the two molecules of the copolymer. Repeated repetition of such reactions leads to the formation of a continuous network of covalent bonds, uniting the entire volume of the mixture, the gel formation process is ongoing.

The injected mixture fills the entire free space of the inguinal canal 1, displacing the hernial sac 16 from it due to hydraulic pressure and gravity. As a result, the polymer formed from the mixture 22 adheres firmly to the walls of the inguinal canal 1, as a result of which an implant is formed - a mechanical obstacle for repeated exit of the hernial sac through the hernial gate. Due to its soft elastic consistency, the resulting polymer implant does not damage the spermatic cord 3, but at the same time, like a “plug”, reliably closes the hernial gate.

Additionally introduced into the preperitoneal fiber 5 mixture 22 after the completion of its polymerization process forms in the preperitoneal fiber 5 in the region of the medial inguinal fossa 9 an additional “plug” 23 (see Fig. 6), which provides even more reliable closure of the hernial portal.

After completing the procedure, the patient must remain in a lying position for approximately 30 minutes, a time sufficient to complete the polymerization of the injected mixture and the resulting implant to acquire sufficient rigidity. After this, the patient can be discharged and observed on an outpatient basis.

Similarly, the mixture is introduced into the inguinal canal 1 in the case of an oblique inguinal hernia (Fig. 7-9). Based on the visible and / or palpable external bone contours, folds, places of resistance and compliance during palpation, it is possible to determine the external inguinal ring, spermatic cord and the course of the inguinal canal. The needle 20 (see Fig. 7) is inserted through the skin into the medial part of the inguinal canal 1 in the region of the external inguinal ring through which the spermatic cord 3. The use of ultrasound control provides a more accurate visualization of the tip of the needle 20 and allows you to monitor its progress in the inguinal channel 1. The mixture 22 is first introduced into the medial part of the inguinal canal 1, so that a “plug” is formed in the region of the lateral inguinal fossa 9 and the medial inguinal fossa 10. The mixture 22 introduced through the needle 20 pushes the spermatic cord 3 to the side and thus gives a safe space for further advancement of the needle 20 in the inguinal canal 1. The smooth and simultaneous introduction of the mixture 22 and the advancement of the tip of the needle 20 are an important point in the implementation of the method in accordance with the invention. The introduction of the mixture 22 is carried out before filling it with the inguinal canal 1 (see Fig. 8).

Additionally, the needle 20 can be advanced through the transverse fascia 6 into the preperitoneal tissue 5 in the region of the lateral inguinal fossa 10, where the introduction of the mixture 22 can be continued (see Fig. 9).

As a result of filling the inguinal canal 1 with the mixture 22 (see Fig. 7), the hernial protrusion is mechanically eliminated due to the displacement of the hernial sac 17 from the spermatic cord 3 and thus from the cavity of the inguinal canal 1. The polymer formed from the mixture 22 is firmly bound to the tissues of the walls of the hernial channel 1, completely filling the volume of the hernial channel 1 and reliably closing the hernial gate.

As in the described case of treatment of a direct inguinal hernia, an implant is formed as a result, which prevents the hernia sac from reappearing through the hernia gate. Due to its soft elastic consistency, the resulting polymer implant does not damage the spermatic cord, but at the same time, like a “cork”, reliably closes the hernial gate.

Additionally introduced into the preperitoneal fiber 5 mixture 22 after the completion of its polymerization process forms in the preperitoneal fiber 5 in the region of the lateral inguinal fossa 10 an additional “plug” 24 (see Fig. 9), which provides even more reliable closure of the hernial portal.

After completing the procedure, the patient must remain in a lying position for approximately 30 minutes, a time sufficient to complete the polymerization of the injected mixture and the resulting implant to acquire sufficient rigidity. After this, the patient can be discharged and observed on an outpatient basis.

The result that is achieved by the implementation of the proposed method is the complete elimination of hernial protrusion due to mechanical displacement of the hernial sac with hernial contents into the abdominal cavity, as well as reliable closure of the hernial portal to prevent relapse. This result is achieved due to the fact that the polymer implant formed from the mixture introduced into the inguinal canal reliably and firmly binds to the tissues of the inguinal canal, is encapsulated and, having sufficient mechanical strength, prevents the passage of the hernia through the hernia gate. At the same time, the operation itself excludes the use of laparoscopy, a complete absence of a cosmetic defect is achieved, the skin integuments remain intact. All this helps to reduce the time of postoperative rehabilitation and quick recovery of the patient.

Claims (17)

1. A method of treating correctable and non-strangulated inguinal hernias, in which a mixture consisting of three solutions A, B and C is injected through the medial part of the inguinal canal into the inguinal canal of a patient lying on his back, wherein: solution A is a solution of a copolymer of acrylamide and hydroxysuccinimide ester of acrylic acid; solution B - a solution of 1,4-butanediamine and succinic acid; solution C - sodium bicarbonate solution, the molar ratio of the units of acrylamide and hydroxysuccinimide ester of acrylic acid in the copolymer of solution A is selected in the range from 9: 1 to 7: 3, the molar ratio of 1,4-butanediamine and succinic acid in solution B is selected in the range from 4: 1 to 1: one, physiological saline is used as a solvent of these substances, moreover the copolymer concentration in solution A is selected in the range of 21.8-26.3 g / l; the concentration of 1,4-butanediamine in solution B is approximately 22.0 g / l; the concentration of succinic acid in solution B is selected in the range of 7.4-29.5 g / l; the concentration of sodium bicarbonate in solution C is selected in the range of 0.6-1.1 mol / l, the quantitative ratio of solutions A and B is selected from the condition that the molar ratio of hydroxysuccinimide ester of acrylic acid in the copolymer and 1,4-butanediamine does not exceed 2: 1, and the quantitative ratio of solutions B and C is selected from the condition that the molar ratio of sodium bicarbonate and succinic acid not less than 2: 1, the mixture is prepared by sequentially mixing solutions A and B, and then solution C, after which the prepared mixture is injected through a needle until the inguinal canal is filled with it and the patient is left in this position until the polymerization process of the mixture introduced into the inguinal canal is completed. 2. The method according to claim 1, wherein said mixture is introduced into the inguinal canal through its external opening or through its front wall. 3. The method according to claim 1, wherein during the introduction of the mixture, the needle is advanced from a substantially external inguinal ring to a substantially transverse fascia. 4. The method according to p. 1, in which in the case of a direct inguinal hernia after filling with the said mixture of the inguinal canal, they additionally pass the needle behind the transverse fascia in the area of the medial inguinal fossa and enter the mixture into the preperitoneal tissue. 5. The method according to claim 1, wherein in the case of an oblique inguinal hernia, after filling the inguinal canal with said mixture, they additionally pass the needle behind the transverse fascia in the lateral inguinal fossa and the mixture is introduced into the preperitoneal tissue. 6. The method according to p. 1, in which the introduction of the mixture into the inguinal canal of the patient is carried out under ultrasound control. 7. The method according to p. 1, in which the introduction of the mixture into the inguinal canal of the patient is carried out under local anesthesia.

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