RU2766268C2 - Method for preventing implant extrusion during two-stage breast reconstruction - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely reconstructive surgery and oncology. Dissection of the skin with subcutaneous fat to the muscle layer is performed. Above the muscle layer of the endoprosthesis capsule, the mobilization of the integumentary tissues is carried out to a width of 1.5 cm in the cranial and caudal direction from the plane of the skin incision, the dissection of the muscle layer and the fibrous capsule is performed. Capsulotomy of the anterior leaf of the endoprosthesis is performed, retreating 1.5 cm from the upper and lower edges of the wound. A permanent implant is installed, separate nodular sutures are applied to the capsule strips adjacent to the edges of the wound with the capture of the muscle layer attached to them into the seam. A continuous suture is applied to the edges of the integumentary tissues, the operation is completed by applying a continuous cosmetic intradermal suture.

EFFECT: method makes it possible to counteract the pressure of the implant from the inside on the integumentary tissues, reduce the risks of eruption and stretching of sutures, completely isolate the implant from the skin wound.

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Description

The present invention relates to medicine, namely to reconstructive surgery, oncology, and can be used in a complex of breast reconstruction operations and is intended for isolating an implant from a skin wound and strengthening it during the second stage of a two-stage breast reconstruction using endoprostheses.

The only effective method of rehabilitation of patients with no breasts recognized in the modern medical community is breast reconstruction, which not only restores the shape of the organ and eliminates body asymmetry, but also, more importantly, improves the quality of life of women (Ermoshchenkova, M.V. The use of biological and synthetic materials in reconstructive plastic surgery in patients with breast cancer / M. V. Ermoshchenkova, V. I. Chissov, A. V. Usov et al. // Research'n. Practical. Medicine. J. - 2017. - No. 1. - T. 4. - S. 23-32). There are many methods in the surgeon’s arsenal for complete breast reconstruction, among which the two-stage breast reconstruction technique using endoprostheses is the most popular today (American society of plastic surgeons. Plastic Surgery Statistics Report. - Access mode: www.plasticsurgery.org/news /plastic-surgery-statistics - 2018). The essence of the operation is the formation of a soft tissue pocket for the installation of the endoprosthesis, as a result of which the covering tissues adhere to the walls of the implant and take its shape. Technically, this method is carried out in two stages, in which at the first stage, a tissue expander is implanted into the subpectoral pocket formed by the pectoralis major and serratus anterior muscles. In the postoperative period, the expander is filled by introducing a sterile isotonic NaCl solution through its port until the volume is reached, which usually exceeds the volume of the planned breast by about one third, due to which the surrounding soft tissues are stretched. Approximately six months later, the second stage of reconstruction is performed, which consists in replacing the tissue expander with a permanent implant.

Installation of an endoprosthesis during breast reconstruction, like any other foreign object in the human body, leads to the formation of a protective shell around it, which is a biologically determined process. The connective tissue capsule formed around the endoprosthesis is a type of scar tissue, which consists mainly of collagen with low elastic properties, which performs a delimiting and fixing role. Therefore, during the second stage of breast reconstruction, it is recommended to perform capsulectomy of the anterior leaflet in order to level the holding function of the capsule, as a result of which it becomes possible to form a classic teardrop-shaped, ptotic form of the breast, which improves the aesthetic results of the operation.

Thus, at the second stage of breast reconstruction, the implant is installed in a pre-formed pocket, consisting of a layer of muscle tissue stretched by the expander with overlying skin and subcutaneous fat. An implant placed in a soft tissue pocket formed for it exerts pressure on the surrounding tissues due to its weight and volume. The pressure force in this case depends on the ratio of the size of the implant to the volume of the pocket formed for it. It should be borne in mind that during expander dermatension, an increase in the area of integumentary tissues occurs as a result of reversible elastic stretching deformation, therefore, due to their elastic properties, dermal structures overstretched by the expander do not lose their ability to contract (Aziz, J. Molecular Mechanisms of Stress-Responsive Changes in Collagen and Elastin Networks in Skin / J. Aziz, H. Shezal, Z. Radzi et al. // Skin. Pharmacology and Physiology. - 2016. - T. 29. - P. 190-203).

After removal of the tissue expander, the tensile force ceases to act, which leads to elastic deformation, which is manifested by skin retraction and some of its constriction around the implant, which occurs until the interstitial pressure normalizes (Tepole, A.V. Growing skin: A computational model for skin expansion in reconstructive surgery / AB Tepole, CJ Ploch, J. Wong et al. // J. Mech Phys. Solids - 2011. - No. 10. - T. 59. - P. 2177-2190). At the same time, the tighter the pocket is eventually formed, the greater the tension is on the edges of the wound and the more pronounced the compressive effect of the surrounding tissues on the endoprosthesis, which has a given volume and shape memory, as a result of which the implant, in turn, presses from the inside on the tightened integumentary tissues. against the deforming force. Therefore, the tension of the wound edges during suturing and additional pressure from the inside on the integumentary tissues of the implant can lead to its divergence, resulting in the exposure of the endoprosthesis with infection by the exogenous microflora of its shell, which becomes the matrix for maintaining the infection. This complication leads to the need to remove the endoprosthesis.

Thus, suturing the surgical wound after implant installation at the second stage of breast reconstruction is an important stage of the operation, the competent implementation of which allows the prophylaxis of endoprosthesis extrusion and its removal. In this case, it should be taken into account that the composition of the integumentary tissues for the implant includes both a layer of chest muscles and a skin sheath, that is, tissues with different biomechanical properties. The skin has the properties of extensibility and elasticity, in contrast to the muscles, which are characterized by a contractile function that allows you to counteract the pressure force of the implant from the inside on the skin cover (Terentiev, A.A. Biochemistry of muscle tissue: a textbook / A.A. Terentiev. // M: N.I. Pirogov Russian National Research Medical University of the Ministry of Health of Russia. -2019.-76 p.).

From the prior art studied by the applicant, a number of methods used for suturing the surgical wound have been identified, the use of which is possible after the installation of the implant at the second stage of breast reconstruction.

The usual, layered suturing with comparison of homogeneous tissues, which is the general surgical canon for suturing the surgical wound (Maslov, V.I. Minor surgery. Manual. / V.I. Maslov, Yu.G. Shapkin. // Infra-M. - 2016. - 248 s), as a result of which the wound is sutured in one plane. However, the problem of suturing the wound after two-stage breast reconstruction using this method does not allow adequately reliable comparison of the edges, which is due to the structural features of the tissues covering the implant. Skeletal muscles consist of muscle fibers that form parallel bundles, shrouded in a connective tissue bag (peremysium), which are interconnected by transverse partitions, consisting of loose fibrous connective tissue (Terentyev A.A. Biochemistry of muscle tissue: textbook / A.A. Terentyev // M.: FGBOU VO Russian National Research Medical University named after N.I. Pirogov of the Ministry of Health of Russia. - 2019. - 76 p.). At the same time, it should be noted that as a result of the previous expander dermatension, the muscle layer becomes thinner. As a result of this structure, with an excessive pressure of the implant from the inside on the integumentary tissues, the skeletal muscle is defibrillated along the fibers. With the failure of the muscle layer, the pressure of the implant begins to act on the overlying skin sheath. However, in the case when the skin cover remains attached to the underlying muscles and the wound is sutured in the same plane, its extensibility and elasticity properties decrease, which leads to the same force of the implant pressure both on the muscle and on the overlying skin. At the same time, the strength of the scar on the 5-10th day after the operation, that is, by the time the skin sutures are removed, reaches only 5-10% of the strength of the intact skin, with its further increase as the scar matures, but even after 100-120 days it makes up only 45-70% of intact skin (Sokolov V.N. Plastic reconstructive and cosmetic surgery / V.N. Sokolov, D.S. Avetikov. - Moscow, 2004. - 340 p.). Thus, the usual layer-by-layer suturing of the surgical wound, under the conditions of previous expander dermatitis and the implant installed at the second stage, does not allow adequate prevention of diastasis of the wound edges and the associated extrusion of the endoprosthesis.

In addition, it is also necessary to note the fact that reconstructive surgery, like any other surgical intervention, is associated with the risk of developing general surgical complications, in particular, infectious complications in the area of the skin wound (since it directly communicates with the external environment) and accumulation of serous fluid. in the periprosthetic cavity. If an infectious reaction occurs in the area of the skin wound, in the case when the skin cover remains attached to the underlying muscles and the wound is sutured in one plane, it is transmitted to the underlying muscle layer, under which the endoprosthesis is directly located, which causes seeding of its shell with an infectious agent with consequent the need to remove the implant. Excessive accumulation of serous fluid in the periprosthetic cavity, when isolated only by the muscle layer, can lead to its seepage through the bundles of muscle fibers and a wound sutured in one plane, which impairs the regeneration process and increases the risk of its edges divergence.

From the prior art investigated by the applicant, a technique for closure of the wound by creating a de-epithelialized skin flap was revealed (RP Cauley, E. Liao. Deepithelialization and extended dermal apposition: a technique for closure of high-risk incisions in breast reconstruction / Plastic and Reconstructive Surgery - Global Open. - 2016. - T. 4. - p 802-803). When applying this method, an elliptical de-epithialization of the upper or lower wound edge is performed to a width of 1-1.5 cm. After that, the de-epithelialized skin flap is sutured with interrupted sutures to the deep layers of the dermis under the contralateral edge of the wound so that the epidermis of both edges of the wound begins to come into contact with each other. When using this technique, the wound is sutured with an overlap, as a result of which the wound channel acquires a curved direction. The use of the above method makes it possible to strengthen the wound by doubling the number of integumentary tissues in the area of the scar and suturing them in different planes, which is the prevention of divergence of the skin edges of the wound and extrusion of the implant. In addition, there is a prevention of leakage of serous fluid, which accumulates in the early postoperative period in the periprosthetic cavity, due to the presence of a curved wound channel. Despite its advantages, the use of this method has certain disadvantages. Carrying out de-epithalization of the skin to a width of 1-1.5 cm leads to a decrease in the area of the skin cover, the excess of which is necessary to create a drop-shaped, ptotic form of the reconstructed breast, in which the implant is lowered anterior to the inframammary fold. A decrease in the area of the skin sheath leads to the implant being pulled up, to the level or above the inframammary fold, which worsens the aesthetic result of breast reconstruction. In addition, doubling the thickness of the integumentary tissues in the area of the scar disrupts the tactile sensations of the reconstructed breast.

From the studied prior art, the method described in RU 2.596.090 C1, 27.08.2015 and chosen by the applicant as a prototype was revealed. The technical result is achieved by the fact that after removing the expander in the lower part of the inner surface of the capsule, a U-shaped incision is made by 1.5 cm without reaching the edge of the wound, the capsule is separated over the subcutaneous fat, while maintaining its attachment at the edge of the wound 1.5 cm wide , the implant is installed, the free edge of the capsular flap is rotated 180° and sutured with a continuous suture to the capsule of the opposite side, going beyond the edge of the wound by 1.5 cm, sutures are placed on the subcutaneous fat and skin. The use of this method makes it possible to achieve reliable shelter of the implant and its isolation from the skin wound through the use of a fibrous capsule of the endoprosthesis. The connective tissue capsule is a type of scar tissue with a dense structure and low elastic properties, as a result of which the sutures placed on it are less prone to eruption and stretching, which makes it possible to achieve reliable fixation of the tissues between them. By maintaining the attachment of the capsule to the overlying muscle, which has a contractile function, the pressure force of the implant is counteracted from the inside on the skin cover. In addition, the presence of a barrier function in the capsule leads to the prevention of leakage of serous fluid formed in the periprosthetic cavity in the early postoperative period through the surgical wound.

However, despite its advantages, this method is not without a number of disadvantages. To create a free capsular flap, leaving attachment to the muscle at the edge of the wound, it is necessary to mobilize it from the integumentary tissues, which is carried out not along the surgeon’s work plane, but in the opposite direction, which is a laborious process in technical terms. Due to this feature of the mobilization of the capsular flap, the time for performing the surgical intervention increases, and, accordingly, the duration of anesthesia, which increases the cost of the reconstructive operation. In addition, the creation of duplication of the capsule leads to the formation of a limited cavity located between the upper and lower walls of the capsule, in which the accumulation of serous fluid is possible. The formation of a seroma in the formed cavity requires a puncture with the evacuation of the accumulated fluid, however, its location directly above the surface of the implant increases the risk of damage to the endoprosthesis wall by the needle.

The purpose of the claimed technical solution is to increase the reliability of suturing the surgical wound and reduce the operation time by reducing the risk of endoprosthesis extrusion during breast reconstruction.

The technical result is achieved, and the task is solved by the proposed method for suturing the surgical wound in a two-stage reconstruction of the mammary gland, which consists in the following:

- performing a skin incision along the previous postoperative scar and dissection of the dermis with subcutaneous fat up to the muscle layer,

- mobilization of the skin with subcutaneous fat from the muscle layer to a width of 1.5 cm in the cranial and caudal direction from the plane of the skin incision,

- dissection of the muscle layer and the capsule of the endoprosthesis,

- removal of the expander,

- carrying out capsulectomy of the anterior leaf, with the exception of a portion of the capsule 1.5 cm wide, attached to the muscle tissue of the upper and lower edges of the wound,

- installation of an implant,

- the imposition of interrupted sutures on the strips of the endoprosthesis capsule adjacent to the edges of the wound with the capture of the muscle layer attached to them into the suture,

- the imposition of a continuous suture on the edges of the mobilized dermis with subcutaneous fat,

- the operation is completed by applying a continuous cosmetic intradermal suture.

The claimed technical solution is illustrated in Fig. 1-Fig. 5 where;

On FIG. 1 is a schematic representation of a reconstructed mammary gland with dissected skin and subcutaneous fat up to the muscle layer and performed mobilization of these tissues from the muscle to a width of 1.5 cm in the cranial and caudal directions from the plane of the skin incision;

On FIG. 2 - a schematic representation of the reconstructed mammary gland with a dissected muscle layer, a fibrous capsule of the endoprosthesis and a remote expander;

On FIG. 3 is a schematic representation of the reconstructed mammary gland after capsulectomy, with the exception of a portion of the capsule 1.5 cm wide attached to the muscle tissue of the upper and lower edges of the wound;

On FIG. 4 - a schematic representation of the reconstructed mammary gland with the implant installed and interrupted sutures applied to the endoprosthesis capsule strips adjacent to the wound edges with the muscle layer attached to them being captured into the suture;

On FIG. 5 is a schematic representation of a reconstructed mammary gland with an implant installed and layers of sutured tissues, where

1 - skin with subcutaneous fat;

2 - muscle layer;

3 - front leaf of the endoprosthesis capsule;

4 - expander

5 - implant.

The method is carried out as follows:

On the operating table, after preliminary marking in the position of the patient on the back, a skin incision is made, usually carried out along the old scar. The dermis is dissected with subcutaneous fat 1 to the muscle layer 2, above which these tissues are mobilized to a width of 1.5 cm in the caudal and cranial direction from the plane of the skin incision (Fig. 1). After that, the muscle layer and the capsule of the endoprosthesis 3 are dissected. The expander 4 is removed (Fig. 2). Next, capsulectomy of the anterior leaf of the endoprosthesis capsule is performed, retreating 1.5 cm from the upper and lower edges of the wound, which is necessary to leave a strip of fibrous capsule attached to the muscle layer (Fig. 3). The next step is to install a permanent implant 5 and the wound is sutured in layers. The first row is sutured by placing separate interrupted sutures on the endoprosthesis capsule strips adjacent to the wound edges with the muscle layer attached to them being captured into the suture (Fig. 4). The next layer is sutured by applying a continuous suture to the edges of the mobilized dermis with subcutaneous fat. The operation is completed by applying a continuous cosmetic intradermal suture (Fig. 5).

The possibility of using the proposed method is confirmed by the following examples of specific implementation in a clinical setting:

Clinical case #1

Patient M, born in 1972. Diagnosis: Cancer of the left breast pT1N1M0, stage Pa., clinical group 2. On June 13, 2017, a radical mastectomy according to Madden was performed with simultaneous implementation of the first stage of breast reconstruction in the form of a tissue expander. In the postoperative period, the expander was gradually filled with physiological saline in order to stretch the skin to the required volume.

On April 9, 2018, the second stage of reconstruction of the left breast was performed: the expander was replaced with a permanent implant. The volume of the implant, installed at the second stage, fully corresponded to the volume of the filled expander. On the operating table, after preliminary marking in the position of the patient on the back, a skin incision was made along the old scar. The dermis with subcutaneous fat was dissected in layers; to the muscle layer, over which these tissues were mobilized to a width of 1.5 cm in the caudal and cranial direction from the edge of the wound. After that, the muscle layer and the capsule of the endoprosthesis were dissected. The expander has been removed. Next, capsulectomy of the anterior leaflet was performed, retreating 1.5 cm from the upper and lower edges of the wound. The next step was to install a permanent implant, one drain into the periprosthetic cavity, and the wound was sutured in layers. The first row was sutured by placing separate interrupted sutures on the strips of the endoprosthesis capsule adjacent to the edges of the wound, with the muscle layer attached to them captured in the suture. The next layer was sutured by applying a continuous suture to the edges of the mobilized dermis with subcutaneous fat. The operation was completed with a continuous cosmetic intradermal suture.

On April 14, 2018, the drainage was removed. On April 19, 2018, the patient complained of induration in the area of the postoperative scar. During the examination, there was a seal in the area of the postoperative scar with a fluctuation symptom, occupying its entire length. The skin was of physiological color, there were no symptoms of inflammation, there was no defect in the healing of the skin wound. Above the site of maximum fluctuation, a puncture was performed with the evacuation of 13 ml of light yellow serous fluid, without pathological impurities. An ultrasound of the mammary glands was prescribed, during which a slight accumulation of serous fluid in the periprosthetic cavity was revealed, no other pathological conditions were found. The patient was invited for a second examination on 04/25/2018. During the control examination, the skin was of a physiological color, no defect in the healing of the skin wound was observed, no symptoms of inflammation were found. In the region of the middle third of the postoperative scar, an area of compaction with a slight symptom of fluctuation was palpated. A repeated puncture of the formation was performed with the evacuation of 5 ml of light yellow serous fluid, without pathological impurities. On repeated ultrasound of the mammary glands, fluid accumulation in the periprosthetic cavity was not detected. In the future, the above symptoms were not observed in the patient.

Six months after the second stage of breast reconstruction, neither cicatricial deformities of the mammary gland, nor subcutaneous seals, nor defects in skin wound healing were noted. The restored mammary gland demonstrated tactile uniformity both in the scar zone and in other departments.

Clinical case #2

Patient K., born in 1978. Diagnosis: Cancer of the right breast pT2N0M0, stage., clinical group 2. On January 24, 2018, a radical mastectomy according to Madzen was performed with simultaneous implementation of the first stage of breast reconstruction in the form of a tissue expander. In the postoperative period, the expander was gradually filled with physiological saline in order to stretch the skin to the required volume.

On September 17, 2018, the second stage of reconstruction of the right breast was performed: the expander was replaced with a permanent implant. The volume of the implant, installed at the second stage, fully corresponded to the volume of the filled expander. On the operating table, a skin incision was made along the old scar. The dermis with subcutaneous fat was dissected in layers to the muscle layer, above which these tissues were mobilized to a width of 1.5 cm in the caudal and cranial direction from the wound edge. After that, the muscle layer and the capsule of the endoprosthesis were dissected. The expander has been removed. Next, a capsulectomy of the anterior leaf was performed, retreating 1.5 cm from the upper and lower edges of the wound. The next step was to install a permanent implant, one drain into the periprosthetic cavity, and the wound was sutured in layers. The first row was sutured by placing separate interrupted sutures on the strips of the endoprosthesis capsule adjacent to the edges of the wound, with the muscle layer attached to them captured in the suture. The next layer was sutured by applying a continuous suture to the edges of the dermis with subcutaneous fat. The operation was completed with a continuous cosmetic intradermal suture.

On September 25, 2018, at the follow-up examination, the failure of the skin suture was revealed in the form of thread eruption in the lower third of the scar, as a result of which diastasis of the skin edges of the wound was observed in an area of 1 cm, with hyperemia of the skin around. The presence of the above symptoms led to the need to excise the area of diastasis with suture repositioning. Why was made elliptical skin incision, bordering the affected area of the skin with its removal. After excision of the area of diastasis, the underlying muscle was exposed, the healing defect of which was not observed. After confirming the integrity of the muscle layer and the absence of exposure of the implant, layer-by-layer suturing of the surgical wound was performed. At subsequent follow-up examinations of the patient, wound healing defects were not observed. After 7 months, there were no cicatricial deformities of the mammary gland, subcutaneous seals. The restored mammary gland demonstrated tactile uniformity both in the scar zone and in other departments.

An analysis of the known methods of covering the endoprosthesis during a two-stage breast reconstruction allows us to state the presence of novelty and differences.

A feature of the claimed technical solution is the use of a fibrous capsule of the endoprosthesis for applying interrupted sutures, which remains attached to the muscle layer, as a result of which the contractile function of the muscles makes it possible to counteract the pressure force of the implant from the inside on the skin with subcutaneous fat, and the capsule reduces the risks of eruption and seam stretching. At the same time, in order to leave a strip of the capsule necessary for the implementation of the claimed method, capsulectomy of the anterior leaf begins to be carried out 1.5 cm from the edges of the wound and along the plane of the surgeon’s work, as a result of which, in technical execution, the operation does not become more complicated, which has a positive effect at the time of surgery. Thus, a reliable strengthening of the postoperative wound is carried out after the installation of the implant during breast reconstruction, in the absence of lengthening the course of the operation and its technical complication.

Carrying out additional mobilization of the skin with subcutaneous fat from the muscles allows you to isolate the skin wound from the layer that strengthens the cavity of the endoprosthesis. Thus, if surgical complications occur in the area of the skin wound, their isolated treatment is possible, without opening the implant cavity and the associated infection of the endoprosthesis with exogenous microflora. In addition, in the case of leakage of serous fluid formed in the early postoperative period in the periprosthetic cavity, it accumulates in the cavity above the muscle layer, which allows its safe puncture evacuation.

It was not possible to find a similar method in the available open Russian and foreign sources of information. The claimed technical solution meets the "novelty" criterion for inventions, since no technical solutions have been identified from the studied prior art that have the claimed set of distinctive features that ensure the achievement of the claimed results.

The proposed method is industrially applicable and does not require additional financial costs. It can be reproduced and repeated many times in specialized oncological and surgical institutions. The technical and economic efficiency of the method lies in the reliable prevention of silicone implant extrusion by completely isolating it from the skin wound and strengthening it.

Claims (1)

A method for preventing implant extrusion during a two-stage reconstruction of the mammary gland, including a skin incision made along an old scar, with a dissection of the dermis with subcutaneous fat to the muscle layer, characterized in that the skin with subcutaneous fat is mobilized over the muscle layer to a width of 1, 5 cm in the cranial and caudal directions from the plane of the skin incision, the muscle layer and the capsule of the endoprosthesis are dissected, the anterior leaflet is capsulectomy, 1.5 cm from the upper and lower edges of the wound, a permanent implant is installed, separate interrupted sutures are applied to the wound adjacent to the edges strips of the capsule with capture in the seam of the muscle layer attached to them, apply a continuous seam to the edges of the dermis with subcutaneous fat, complete the operation by applying a continuous cosmetic intradermal seam.

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