RU2764353C2 - Method for coagulation after vacuum assisted biopsy and/or removal of breast neoplasms using laser interstitial radiation - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to mammology. A light guide with a cylindrical scattering lens is inserted through the working channel of a biopsy probe needle into the cavity under ultrasonic control. Coagulation is therein performed by laser radiation with a wavelength of 1,560 nm and a power of 15 W by means of automatic rotation of the biopsy probe needle along the upper semi-circumference of the cavity, wherein coagulation is executed for 12 s. After extracting the biopsy probe needle, an arthroscopic camera is inserted through the wound canal into the cavity under ultrasonic control, hemostasis and effectiveness of laser radiation are assessed.

EFFECT: method allows for stable hemostasis after vacuum assisted biopsy and in removal of both multiple and single benign breast neoplasms, thereby reducing the compression time to 16-24 hours and providing a more comfortable period of early rehabilitation of patients.

1 cl, 2 tbl, 2 dwg

Description

Technical field

The present invention relates to medicine, in particular to the diagnosis and treatment of benign breast tumors.

State of the art

Breast neoplasms are diagnosed in patients of all age categories, including children, and generally affect about 25% of the female population worldwide. The most common benign tumors of the mammary glands include fibroadenomas, nodular forms of fibrocystic mastopathy, cysts, intraductal papillomas [1, 2].

For a long time, having no technical alternative, the only method of surgical treatment of benign breast tumors was sectoral resection [2]. At the same time, non-palpable formations of small size were often not removed or partially removed due to the difficulty of intraoperative detection by palpation and visual assessment through a small incision. This entails not only an increase in the time of the operation, but also the expansion of the surgical wound. The invasiveness of the operation, often accompanied by an unsatisfactory cosmetic effect, followed by a negative psycho-emotional state, was a deterrent not only for doctors, but also for patients [3, 4, 6].

Today, an alternative to classical sectoral resection, devoid of its disadvantages, is vacuum aspiration biopsy and resection under X-ray and ultrasound control [5,7,8]. The technique of vacuum aspiration biopsy (VAB) is as follows: under the control of ultrasound, through a skin puncture using a needle with a cutting rotary mechanism, the object is completely removed by vacuum into a special external container. The manipulation is performed under local anesthesia and takes 15-20 minutes. Within 2 hours after the manipulation, the patient goes home, remaining fully able-bodied. There is no cosmetic defect in the form of cicatricial deformities of soft tissues after this manipulation - suturing is not required for skin puncture.

An important aspect of the PSA procedure is the achievement of hemostasis-i.e. prevention of hemorrhages and hematomas. This is achieved by preoperative drug correction (within 2 days before the procedure, taking tranexam 500 mg 2 times a day), and by applying a pressure bandage immediately after performing the VAB (elastic bandage with compression class 2 for up to 32-40 hours). When using this method of coagulation after PSA, we noted subcutaneous bruising and hematomas in the early postoperative period, the frequency of manifestations of which depended on the amount of PSA performed. If after VAB and removal of single formations, the frequency of hematomas and bruises was in isolated cases, then in more than half of the cases this occurred after a single-stage bilateral VAB, and VAB and removal of multiple formations, respectively (Table 1).

Table 1. The frequency of hematomas and hemorrhages as a result of PSA and removal of neoplasms using medical-compression coagulation in 2017

No. p / p Name of manipulation Number of patients
(n=85) Hematomas and hemorrhages
n(%) one. Removal of a single formation 58 5 (8.6%) 2. Removal of multiple formations 27 11 (40.7%) 3. Unilateral VAB 60 7 (11.6%) 4. Bilateral VAB 25 14 (56%)

To clarify the genesis of hematomas after VAB and removal of formations (2 cm), endoscopic visualization of the cavity was performed by inserting a manipulator needle through the wound channel after removal of the needle under ultrasound control of the arthroscopic video camera of the KARL STORZ system. In all cases, the presence of bleeding into the cavity was noted (Fig. 1). Of course, the visualized intensity of bleeding did not pose a threat, and compression immediately after manipulation was sufficient to stop bleeding. However, it is not possible to create adequate compression when removing multiple formations, bilateral PSA is not possible. This was the reason for the higher frequency of bruising and hematomas with such a volume of manipulations [9].

Based on the results obtained, it can be concluded that the prescribed measures for the prevention of hemorrhages and hematomas were effective in unilateral PSA and removal of single formations, but not always effective in the removal of multiple formations and bilateral PSA. The proposed method of laser coagulation to increase the dignity of the method of vacuum aspiration biopsy requires a method of stable hemostasis in unilateral and bilateral VAB, both in the removal of single and multiple formations.

The closest technical solutions to this invention, adopted as a prototype are diathermocoagulation using a device with a cryogenic probe for minimally invasive removal of breast tumors [10]; a method for the surgical treatment of benign nodular formations of the mammary gland, including the use of laser irradiation with a diode laser by introducing an optical fiber into the formation under ultrasound control [11]; into its thickness through a puncture needle [12].

Disclosure of the essence of the invention

The objective of the invention is to achieve stable hemostasis after vacuum aspiration biopsy and removal of benign breast tumors under ultrasound control.

The essence of the invention lies in the implementation of coagulation by low-intensity laser radiation through the working channel of the biopsy needle-probe, which reduces the compression time to 16-24 hours and provides a more comfortable period of early rehabilitation.

Implementation of the invention.

Vacuum biopsy and resection under local anesthesia using a 1% solution of naropin from 40 to 50 ml were performed on the EnCor ENSPIRE apparatus with probes-needles 7 and 10 G.

For ultrasound imaging, a Hitachi F37 apparatus with a 7.5 MHz linear transducer was used. (registration certificate FS No. P3H 2013/402. dated 10/31/16).

To carry out coagulation using laser interstitial radiation, a laser device was used (a laser multimode surgical device MEDIOLA----ALMOKH-0.1 / 0.25-"LAMI", OOO "Opttekhnika"; registration

MZRF certificate No. 29/10020203/5212-03 dated May 20, 2003; certificate of conformity №Ross ru. AE68.B12482. dated October 10, 2007), and a flexible light guide with a circular radiation lens (a set of products for intravenous blood irradiation with low-intensity laser radiation KIVL-01 according to TU9444-001-17515211-98, Polyronic LLC).

After the performed PSA and removal of the formation, a flexible light guide with a cylindrical lens of dispersion was inserted into the working channel of the biopsy needle-probe. Then, by turning on the automatic rotation of the needle-manipulator along the upper semicircle, coagulation was performed with a laser with a wavelength of 1560 nm. The radiation power was 15 W in the pulsed mode. The radiation delivery time is limited to 12 s.

To assess hemostasis and control the effectiveness of laser radiation, visualization of the cavity was performed. To do this, after removing the manipulator needle, an arthroscopic video camera of the KARL STORZ system was inserted through the wound channel under ultrasound control. In all cases, there was no bleeding into the cavity and no signs of thermal tissue destruction after laser irradiation (Fig. 2).

Experimental and clinical trials were carried out at the Central Clinical Hospital of the Russian Academy of Sciences, Moscow. The method was tested after 295 vacuum aspiration biopsies and removal of mammary tumors from 1 to 2 cm were performed. The results of testing the method are presented in table 2.

Table 2. The frequency of hematomas and hemorrhages as a result of PSA and removal of neoplasms using laser coagulation in 2018-2019

No. p / p Name of manipulation Number of patients
(n=295) Hematomas and hemorrhages
n(%) one. Removal of a single formation 180 3 (1.7%) 2. Removal of multiple formations 115 5(4.3%) 3. Unilateral VAB 235 5 (2.1%) 4. Bilateral VAB 65 3 (4.6%)

The data in the table show that the application of the proposed method has significantly reduced the frequency and likelihood of hematomas and bruising. After removal of single formations 5 times (from 8.6% to 1.7%), after removal of multiple formations 9 times (from 40.7% to 4.3%). After unilateral VAB by 5.5 times (from 11.6% to 2.1%), after simultaneous bilateral VAB by 12 times (from 56% to 4.6%) [13].

There were no significant complications after coagulation. In isolated cases, burning and pain were noted during coagulation. This phenomenon was eliminated by additional injection of anesthetic through the working channel of the manipulator needle. In cases of localization of remote formations close to the skin, in the early postoperative period, local hyperemia of the skin and tissue infiltration in the area of the remote formation were observed.

Bibliography

1. Goncharov A.V., Apanasevich V.I., Mordvinov Yu.P., Pavlyuk E.G. Minimally invasive breast surgery: vacuum total biopsy // Tumors of the female reproductive system. -2017.- №1.- From 20-24

2.Adamyan A.G. Periareolar access for sectoral resection of the mammary gland. Khirurgiya. - 1986. - No. 9. - S. 29-31

3. Lazarev A.F. et al. Improving mammological care in the Altai Territory // Topical issues of mammology. Materials of the interregional scientific-practical conference. - Barnaul, 2001. - S. 106-109.

4. Yakovets E.A., Kulikov V.G. Innovative approaches in breast surgery. // Modern problems of science and education // Modern problems of science and education. - 2015. - No. 1-1.8.

5. Skurikhin S.S., Suvorova Yu.V. Vacuum aspiration biopsy in mammological practice. Analysis of 3 years of application experience. // Tumors of the female reproductive system. - 2020. -№2. - pp. 19-24

6. Burbank F. Stereotactic breast biopsy of atypical ductal hyperplasia and ductal carcinoma in situ lesions: improved accuracy with directional, vacuum-assisted biopsy. radiology. 1997; 202:843-847.

7. Regolo L., Coppola M., Angelini L. Periareolar subcutaneous quadrantectomy: a new approach in breast cancer surgery. G Chir. - 2002. No. 23.

8. Victor J. Zannis, MD, Kristina M. Aliano, The Evolving Practice Pattern of the Breast Surgeon with Disappearance of Open Biopsy for Nonpalpable Lesions RT(M), Phoenix, Arizona., The American journal of surgery® volume 176 december 1998 ; 525-528

9. Levanov A.V., Marushchak E.A., Pletner P.D., Magomedova P.T. Ultrasound navigation for vacuum aspiration biopsy in breast neoplasms - from diagnostic to therapeutic significance // Ultrasonic and functional diagnostics. Appendix to the magazine. -№3-2019-S.48

10. Cherenkov V.G., Loktionova M.A., Ivanchenko V.V., Tverezovsky S.A., Khazov A.V. A method for minimally invasive removal of tumor diseases of the breast and a device for its implementation // RF Patent 2394521 dated 07/20/2010

11. Alekhin A.I., Bogatyrev O. et al. Method for the treatment of nodular benign neoplasms of the mammary gland // RF Patent 2381765 dated 20.02.2010

12. Mumladze R.B., Yakovlev V.N. et al. Method of surgical treatment of benign thyroid nodules // Patent RF 2438604 dated 10.01.2012

13. Levanov A.V., Marushchak E.A., Melkumova N.A., Kuzumova A.A., Pletner P.A. Vacuum aspiration biopsy in breast neoplasms from diagnostic to therapeutic significance // Collection of materials of the international scientific and practical conference "Modern medicine: new approaches and current research" - 2020 - P. 55-58

Claims (1)

A method of coagulation after performing a vacuum aspiration biopsy and/or removal of benign breast tumors by laser radiation, including insertion of a biopsy needle-probe through the working channel into the cavity under ultrasound control of a light guide with a cylindrical dispersion lens, characterized in that coagulation is performed by laser radiation with a wavelength 1560 nm and a power of 15 W, by automatically rotating the biopsy needle-probe along the upper semicircle of the cavity, while coagulation is carried out for 12 s, hemostasis and the effectiveness of laser radiation are assessed after removing the biopsy needle-probe by inserting it through the wound channel into the cavity under ultrasound - control of the arthroscopic video camera.

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