RU2760620C2 - Method for thoracic defect replacement by individual 3d implant - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: individual 3-D implant for replacing the tumor-affected area of the sternum in the size from the jugular notch to the interval between the second and third costal notches of the sternum body, made by layer-by-layer fusion of metal powder based on the results of computed tomography of the chest wall and using the obtained scans. The implant is made in the form of a perforated volumetric body in the form of a "crab" with interconnected internal cavities, having two costal processes on each side, equipped with "pincer" joints having a lower part fused with the body, and the upper part is movable, attached to the lower one by means of a connection Ear-plug. The upper and lower parts are made with through holes for conducting the wire. The body in the form of a "crab" has a rough surface on the inner and outer sides, and its costal processes have a rough surface only on the inner side. The method for replacing a defect in the chest wall with an individual 3-D implant is characterized by the fact that a plastic trial template is used to determine the border of resection of the ribs, sternum and sternotomy and the above implant. During the operation, the internal thoracic artery is isolated from both sides in the second intercostal space using a standard approach, transected and ligated, the aforementioned template is applied, and the boundaries of the resection of the ribs, sternum and sternotomy are determined. After marking, the said template is removed and the sternum is crossed along the marked boundaries at the point of attachment of the third ribs. The first and second ribs are resected along the boundaries indicated by the said template. Cartilaginous segments of 1 and 2 ribs are resected on both sides. Acute and blunt way, the tumor is separated from the mediastinum. The clavicles are dislocated from the joints. The preparation is removed, after which the above implant is fixed through the perforation of the body to the edges of the resection of the ribs, clavicle and sternum with wire. The pectoralis major muscles are sutured through the perforated body to the above implant. The lower part of the "pincer" connector is inserted from the inner side of the rib, and the movable upper part is folded back, closed and fixed with a wire through the through holes of the "pincer" connector.

EFFECT: inventions provide a reduction in trauma during the operation and an increase in the aesthetic effect.

2 cl, 7 dwg

Description

The invention relates to medicine and can be used in oncology, traumatology, reconstructive surgery when performing the reconstruction of the chest wall.

The standard of treatment for primary and metastatic tumors of the chest wall is a combination or combination therapy. Conducting preoperative treatment helps in some cases to create more favorable conditions for performing the surgical stage of treatment. The main treatment for chest wall tumors is surgery [Bagheri R., Haghi SZ, Kalantari MR, Sharifian Attar A., Salehi M., Tabari A., Soudaneh M. Primary malignant chest wall tumors: analysis of 40 patients // J. Cardiothorac. Surg. 2014. Vol. 9. P. 106. doi: 10.1186 / 1749-8090-9-106]. Moreover, the choice of the method of replacing the post-resection defect of the chest wall is of particular importance in order to preserve the physiological volume of the chest, restore the skeleton of the chest, prevent paradoxical breathing, seal the pleural cavity [Davydov MI, Aliev MD, Sobolevsky V.A. , Ilyushin A.L. Surgical treatment of malignant tumors of the chest wall. // Bulletin of the Blokhin Russian Cancer Research Center. 2008.Т 19.No. 1.С35-40 .; Zheravin A.A., Gunther V.E., Anisenya I.I., Garbukov E.Yu., Zhamgaryan G.S., Bogoutdinova A.V. Chest wall reconstruction using titanium nickelide in cancer patients // Siberian Journal of Oncology. 2015 .№3. С 31-37; Chudacek J., Bohanes T., Szkorupa M., Klein J., Stasek M., Zalesak B., Stehlik D., Ctvrtlík F., Neoral C. Strategies of treatment of chest wall tumors and our experience // Rozhl. Chir. 2015. Vol. 94 (1). P. 17-23 .; Abraham V.J., Devgarha S., Mathur R.M., Sisodia A., Yadav A. Dedifferentiated Chondrosarcoma of the Rib Masquerading as a Giant Chest Wall Tumor in a Teenage Girl // Korean J. Thorac. Cardiovasc. Surg. 2014. Vol. 47 (4). P. 427-430. doi: 10.5090 / kjtcs.2014.47.4.427].

Currently, various techniques are used to reconstruct the bone frame, and the body's own tissues (bone autoplasty, displaced flaps), polymer meshes (polypropylene, Gor-Tex - polytetrafluoroethylene), bone cement (methyl methacrylate), structures made of stainless steel and titanium, titanium construction "Stratos" [Bennett DT, Weyant MJ Extended chest wall resection and reconstruction in the setting of lung cancer // Thorac Surg Clin. 2014. Vol. 24 (4). P. 383-390. doi: 10.1016 / j.thorsurg.2014.07.002 .; Mahabir R.C., Butler C.E. Stabilization of the Chest Wall: Autologous and Alloplastic Reconstructions // Semin. Plast. Surg. 2011. Vol. 25 (1). P. 34–42. doi: 10.1055 / s-0031-1275169]. Despite the abundance of available techniques for the reconstruction of the chest wall, the search for new materials and methods of their application is urgent.

Of particular interest are extended radical surgical interventions on the chest wall with simultaneous combined reconstruction of the rib frame with implants made of biologically compatible materials [Mansour K.A., Thourani V.H., Losken A., Reeves J.G., Miller J.I. Jr., Carlson G.W., Jones G.E. Chest wall resections and reconstruction: a 25-year experience // Ann. Thorac. Surg. 2002. Vol. 73 (6). P. 1720-1726; Berthet J.P., Canaud L., D'Annoville T., Alric P., Marty-Ane C.H. Titanium plates and Dualmesh: a modern combination for reconstructing very large chest wall defects // Ann. Thorac. Surg. 2011. Vol. 91 (6). P. 1709-1716. doi: 10.1016 / j.athoracsur.2011.02.014 .; Berthet J.P., D'Annoville T., Canaud L., Marty-Ané C.H. Use of the titanium vertical ribs osteosynthesis system for reconstruction of large posterolateral chest wall defect in lung cancer // Interact. Cardiovasc. Thorac. Surg. 2011. Vol. 13 (2). P. 223-225. doi: 10.1510 / icvts.2011.269175 .; Khalil el-SA., El-Zohairy M.A., Bukhari M. Reconstruction of Large Full Thickness Chest Wall Defects Following Resection of Malignant Tumors // J. Egypt. Nat. Cancer Inst. 2010. Vol. 22 (1). P. 19-27; Matsumoto K., Sano I., Nakamura A., Morino S., Yamasaki N., Tsuchiya T., Miyazaki T., Nagayasu T. Anterior chest wall reconstruction with titanium plate sandwiched between two polypropylene sheets // Gen. Thorac. Cardiovasc. Surg. 2012. Vol. 60 (9). P. 590-592. doi: 10.1007 / s11748-012-0048-9 .; Nazerali R., Rogers J., Canter R., Hinchcliff K.M., Stevenson T.R. The use of polypropylene mesh in chest wall reconstruction; a novel approach // J. Plast. Reconstr. Aesthet. Surg. 2015. Vol. 68 (2). P. 275-276. doi: 10.1016 / j.bjps.2014.09.036].

However, all known wire-based systems usually lead to one or more disadvantages:

- the wire cuts into the bones;

- fragmentation of the sternum;

- wire breakage;

-sternotomy from the outside.

Known module for frame reconstruction of the chest "(RU 2694213 C1), made of superelastic titanium nickelide, in the form of a flat regular, unidirectionally translated wire structure from a sequence of loop-like bends located relative to the translation axis. The invention provides an increase in the consistency of the operation and an increase in the period of operation.

Known device for closing defects of the chest, containing two clamps (Patent US 6051007). The first and second clips have a tubular shape, the second clip can be slidably fixed within the first clip.

A device for closing a chest defect with a double locking mechanism is known (WO 2020146669 A1, MavrekMedical). The device includes an insert member, a receiving member and a joint locking mechanism. The hinge locking mechanism includes a double latch assembly and a double ratchet assembly. The dual pawl assembly includes a pair of pawl levers that include outward-facing teeth. The dual ratchet assembly includes a pair of inward-facing ratchet arms that are configured to intermesh with teeth on respective pawl arms. The locating lugs on the ratchet arms are fixed in the guide channels on the receiving element. The configuration and number of teeth contribute to the strength of the device. The locking mechanism contributes to the efficiency, speed and strength of the closure.

The prototype is a surgical device for gripping, positioning and aligning parts of the human sternum (US 7033377 B2). The device is positioned around the costal cartilaginous portion of each of the paired set of ribs located on opposite sides of the resected sternum, simultaneously surrounding the anterior and posterior portions of the sternum, containing connected insertion guide attachment members, each of which has first and second end portions, first and second side portions , a body part, anterior and posterior surfaces, two half-moon-shaped leg parts with angled parts, a plurality of engagement surfaces with the sternum, rib and costal cartilage, and a pivotal locking element pivotally attached to the insertion guide, further comprising a gripping mechanism having angled toothed structures on the first side interacting with reciprocating tooth structures integrated on the first side of the plug-in element for positioning, fixing in place and functional integration of the plug-in element, the pivot lock, etc. insert guide.

However, the disadvantages of all known devices are:

- high risk of cutting through the device (wire devices);

- trauma, unsatisfactory aesthetic and functional results;

- lack of congruence with a defect due to the choice of the method of manufacturing structures;

- many locking mechanisms used in thrust devices fail under increased loads;

- the complexity of manipulation and their impossibility to quickly remove;

- devices with multiple parts or segments that need to be pivotally connected and spot welded increase the likelihood of device failure.

In view of the shortcomings of clamping surgical devices and, in addition, due to life-threatening conditions, a search is underway for new technical solutions that can solve the existing problems of the known devices.

The technical result is the creation of an individual 3-D implant for replacing the tumor-affected area of the sternum in the size from the jugular notch to the gap between the second and third costal notches of the sternum body, as well as reducing trauma during surgery and increasing the aesthetic effect.

The technical result is solved in that, as in the known device (US 7033377 B2), frame reconstruction of the chest is carried out by fixing the ribs and costal cartilage to the resected part of the sternum with the help of fixing fasteners.

A distinctive feature of the device is that an individual 3-D implant for replacing the tumor-affected area of the sternum in the size from the jugular notch to the interval between the second and third costal notches of the sternum body, made by layer-by-layer fusion of metal powder based on the results of computed tomography of the chest wall and using of the obtained scans, in the form of a perforated volumetric body in the form of a "crab" with interconnected internal cavities, having two costal processes on each side, equipped with "pincer" joints, which have the lower part fused with the body, and the upper part is movable attached to the lower one by means of the connection " ear ", and the upper and lower parts are made with through holes for conducting the wire, the body in the form of a" crab "has a rough surface on the inner and outer sides, and its costal processes have a rough surface only on the inner side. To replace the defect of the chest wall with an individual 3-D implant, a plastic trial template is used to determine the border of resection of the ribs, sternum and sternotomy, and the implant during the operation using a standard approach in the second intercostal space, the internal thoracic artery is isolated from both sides, transected and ligated, the said template is applied and the boundaries of the resection of the ribs, sternum and sternotomy are determined, after marking, the mentioned template is removed and along the marked boundaries the sternum is crossed at the point of attachment of the third ribs, the first and second ribs are resected along the boundaries indicated by the said template, the cartilaginous segments 1 and 2 of the ribs are resected on both sides, by an acute and blunt way, the tumor is separated from the mediastinum, the clavicle is dislocated from the joints, the drug is removed, after which the implant according to item 1 is fixed through the perforation of the body to the edges of resection of the ribs, clavicle and sternum with wire, the pectoralis major muscles are sutured through the perforated body to the implant according to item 1, the lower part of the "glue of the “pincer” connector is inserted from the inner side of the rib, and the movable upper part is folded back, closed and fixed with a wire through the through holes of the “pincer” connector.

An important difference is that the structure is designed individually for a specific defect of the patient, and the fasteners are guided in the direction of the most pronounced bone mass specified during the design.

The invention is illustrated by a detailed description and illustrations, which depict:

Fig. 1 is a diagram of a defect in the chest wall shown in red: a) 1 - an approximate template (green); b) side view.

FIG. 2 - a diagram of the location of a 3-D implant in the chest wall: 2 - a perforated volumetric body in the form of a "crab"; 3 - costal processes; 4- "pincer" connections (green).

FIG. 3 - diagram of the "pincer" connection - 4: a) closed and b) open: 5 - upper part of the connector, 6 - lower part of the connector, 7 - through holes in the upper and lower parts of the connector; 8 - ear-plug connection.

4 is an illustration of a "pincer" connection during fixation.

Fig. 5 - Photo-illustration of a 3-D implant for replacing a defect in the chest wall: a) top view; b) bottom view.

Fig. 6 is a photographic illustration of the surgical intervention: the result of replacing the chest wall with a 3-D implant.

FIG. 7 - X-ray after surgery to replace the chest wall with a 3-D implant.

The method is performed as follows.

Before surgery, at the first stage, the localization of the alleged defect of the chest wall is determined. Next, a three-dimensional computer simulation of the required geometry of the template for resection, corresponding to the alleged defect of the chest wall, is performed. The required structure, graft geometry and fastening holes are modeled.

After planning, the device is 3D printed using a 3D printer by direct laser sintering by 3D printing from titanium powder in the form of a lightweight perforated 3-D implant (Fig. 2). A 3-D implant is made taking into account anthropometric data obtained on the basis of a preoperative examination (CT), which accurately repeats the anatomical features and geometry of the resected chest wall fragment before the tumor appears. Additionally, a plastic trial template 1 is printed (Fig. 1 a, b).

An individual 3-D implant for replacing a defect in the chest wall (Fig. 1-3) consists of: a perforated volumetric body in the form of a "crab" 2 with interconnected internal cavities, having on each side two costal processes 3, equipped with "pincer" joints 4 (Fig. 2) with through holes 7 (Fig. 3 b), and the upper part 5 of the "pincer" connection 4 is movable and is attached by means of the ear-plug connection 8, and the lower part 6 is fused with the body 2 (Fig. 3 b) ... During the operation, the clavicle bones in the glenoid cavity are fixed with wire. For this, in the upper 5 and lower 6 parts of the "pincer" joints (Fig. 3 a) there are holes 7 for conducting the wire (Fig. 3 b). Body 2 has a rough surface on the inner and outer sides, and costal processes 3 have a rough surface only on the inner side (for better adhesion to bone structures).

During the operation, the internal thoracic artery is isolated from both sides in the second intercostal space using a standard approach, transected and ligated. Approximate template 1 is applied (Fig. 1 a, b) and the boundaries of the resection of the ribs, sternum and sternotomy are determined. After marking, the template is removed. Along the marked boundaries, the sternum is crossed at the point of attachment of the third ribs. The first and second ribs are resected along the borders indicated by the template (depending on the localization of the defect). Using Liston costal nippers, resection of cartilaginous segments 1 and 2 ribs on both sides is performed. Acute and blunt way, the tumor is separated from the mediastinum. The clavicles are dislocated from the joints. The drug is removed. Hemostasis. Then the sternocostal implant (Fig. 2) is fixed through the perforation of the body 2 to the edges of the resection of the ribs, clavicle and sternum with wire. The pectoralis major muscles are sutured to the 3-D implant through the perforation of the body 2. Since the lower part 5 of the "pincer" connector 4 (Fig. 3 a, b) is made monolithic with the common body of the 3-D implant 2, it is inserted from the inside of the rib ... The movable upper part 5 of the "pincer" connector 4 is folded back, closed and fixed with a wire through the through holes 7 in the upper 5 and lower 6 parts of the "pincer" connector, providing a stronger connection (Fig. 3 a, b, Fig. 5 a, b) ...

Clinical example of implementation.

Patient B., diagnosis C73 Thyroid cancer pT4N0M0. Surgical treatment (09/25/2018 - thyroidectomy, median lymphadenectomy). Progression from 2020 - metastatic lesion of the bones of the skeleton (upper third of the left femur, sternum handle).

From the anamnesis: Since 2015, he was observed for nodules in the thyroid gland. He did not receive any treatment. In 2018, he noted the appearance of pain in the left hip joint. Ultrasound of the thyroid gland in 2018 revealed the growth of nodules in dynamics. In TIAB, a follicular tumor, probably an adenoma. Surgical treatment was performed (Rostov-on-Don GBU RO "OKB No. 2") September 25, 2018 - thyroidectomy, median lymphadenectomy. Histology - papillary cancer, follicular, sclerosing variant, occupying the entire volume of the thyroid gland, with the germination of the capsule of the gland, invasion of the perithyroid fatty tissue, invasion of the venous and arterial vessels, invasion of the isthmus and the left lobe of the thyroid gland. MRI of the hip joints dated 04/15/2020 - a picture of the volumetric formation of the proximal metaphysis of the left femur. CT scan of the hip joints from 06/07/2020 - CT picture of the formation (68x50x89 mm) of the upper third of the diaphysis of the left femur. Consulted at the FF Tsyba MRRC - it was decided at the first stage to carry out surgical treatment in the volume of segmental resection of the upper third of the left femur with endoprosthetics of the left hip joint. At the second stage, surgical treatment in volume - removal of the sternum tumor. Endoprosthetics of the sternum.

After the surgical treatment - the decision of the issue of radioiodine therapy.

Stage I. On August 21, 2020, the operation "Segmental femoral resection with endoprosthetics" was performed.

Stage II. 12/11/2020 - Resection of the sternum with combined plastic. Endoprosthetics of the sternum with an individual sternocostal 3-D implant.

CT scan of the chest organs was performed to plan the boundaries of resection and the geometry of the implant. After planning, the device was 3D printed using a 3D printer by direct laser sintering by 3D printing from titanium powder in the form of a lightweight perforated 3-D implant (Fig. 2). A plastic trial template was made (Fig. 1 a, b).

Description of the operation: The skin was exposed by the combined incisions bordering the tumor of the sternum. Acute and blunt subcutaneous dissection of fatty tissue and muscles. The indentation from the tumor is 1.5 cm. In the second intercostal space, the internal thoracic artery is highlighted on both sides, tied twice, and transected. Attached is a sample template (Fig. 1 a, b), the boundaries of the resection of the ribs and sternum are determined. Passed with a sternot, the sternum is crossed at the point of attachment of the third ribs. Using Liston costal nippers, resection of cartilaginous segments 1 and 2 ribs was performed on both sides. Acute and blunt way, the tumor is separated from the mediastinum, without growing into the anatomical structures. The clavicles are dislocated from the joints. The drug has been removed. Hemostasis. Trocars 10 mm and 5 mm were inserted in the umbilical region, right and left hypochondrium. Superimposed carboxyperitoneum. The omentum was mobilized in an acute and blunt way, passed through the subcutaneous tunnel in front of the sternum. Control for hemostasis is dry, foreign bodies are not. Elimination of pneumoperitoneum. Abdominal wall defects were sutured. The 3-D implant (Fig. 5) was fixed to the edges of the resection of the ribs, the clavicle and the sternum with wire through the holes of the pincer joints and the holes in the body of the implant, and the pectoralis major muscles were sutured only to the body of the implant (Fig. 6).

The metal structure was closed with an omentum and fixed to the pectoral muscles with separate interrupted sutures. Layer-by-layer wound closure. Intradermal suture. Aseptic stickers.

The postoperative period was uneventful. The patient was discharged from the hospital on the 10th day after the operation.

At control radiography - the structure is stable (Fig. 7).

The proposed 3-D upper thorax implant is intended to replace the tumor-affected area of the sternum in the size from the jugular notch to the gap between the second and third costal notches of the sternum body.

The use of the present invention leads to a decrease in pain in a patient in the postoperative period, a decrease in the likelihood of infection in the operation area, a decrease in the risk of bleeding, and a decrease in the likelihood of repeated surgeries. The device does not make sternum replacement heavier and minimizes the trauma of its use.

For physicians, the benefits include: ease of use, shorter operation times, better efficacy.

Due to its individuality, the device completely adheres congruently to the contour of the chest wall defect, ensuring maximum adherence of the structure to the surface of the chest wall and its stability. Thus, the operation time and its invasiveness are reduced, the functional and aesthetic result of the surgical intervention is significantly improved.

This design makes it possible to achieve an increase in the cosmetic effect of the operation with a significant resection area, as well as the convenience and strength of the quick fastening of the device itself.

Claims (2)

1. An individual 3-D implant for replacing the tumor-affected area of the sternum in the size from the jugular notch to the interval between the second and third costal incisions of the sternum body, made by layer-by-layer fusion of metal powder based on the results of computed tomography of the chest wall and using the obtained scans, in the form a perforated volumetric body in the form of a "crab" with interconnected internal cavities, having two costal processes on each side, equipped with "pincer" joints having a lower part fused with the body, and the upper part is movable, attached to the lower one by means of an ear-plug connection ", And the upper and lower parts are made with through holes for conducting the wire, the body in the form of a" crab "has a rough surface on the inner and outer sides, and its costal processes have a rough surface only on the inner side. 2. A method of replacing a defect in the chest wall with an individual 3-D implant, characterized by the fact that a plastic trial template is used to determine the border of resection of the ribs, sternum and sternotomy, and the implant according to claim 1, during the operation, the internal thoracic artery is isolated in the second intercostal space using a standard approach on both sides, cross and ligate, apply the mentioned template and determine the boundaries of the resection of the ribs, sternum and sternotomy, after marking the said template is removed and along the marked boundaries the sternum is crossed at the point of attachment of the third ribs, the first and second ribs are resected along the boundaries indicated by the mentioned template, resection of cartilaginous segments of 1 and 2 ribs from both sides is performed, the tumor is separated from the mediastinum in an acute and blunt way, the clavicle is dislocated from the joints, the drug is removed, after which the implant according to item 1 is fixed through the perforation of the body to the edges of the resection of the ribs, clavicle and sternum with wire, pectoralis major muscles are sutured through the perforated body to them the plant according to claim 1, the lower part of the "pincer" connector is wound up from the inner side of the rib, and the movable upper part is folded back, closed and fixed with a wire through the through holes of the "pincer" connector ".

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