RU2721822C1 - Heart aortic valve formation device - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to cardiovascular surgery, and can be used for surgical management of aortic valve defects. A cardiac aortic valve formation device comprises a retaining portion, a washer and a working portion. Retaining portion is made in the form of three metal pins soldered on proximal end, and ends with handle. Washer is put on wires through three holes in it with possibility of free movement from proximal end to distal end. Working part on the distal end consists of three parts rigidly fixed on the pins with possibility of opening when the washer is moved to the proximal end and closed when the washer moves to the distal end, each of the parts being shaped as a sine of the semilunar valve.

EFFECT: using the invention enables forming a new aortic valve of the heart by creating autopericardium neoleaflets.

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Description

The invention relates to medicine, namely to cardiovascular surgery, and can be used for the surgical treatment of aortic valve defects.

Currently, mechanical or biological prostheses are widely used to treat aortic valve defects. The disadvantages of mechanical prostheses are lifelong administration of anticoagulants, prosthetic thrombosis, frequent embolic complications, hemolysis, and acoustic discomfort. After implantation of bioprostheses, continuous use of anticoagulants is not required, but prostheses are subject to degenerative changes, which increases the risk of reoperation and limits their use in patients younger than 65 years of age.

It is known to restore the aortic valve using an autopericardium treated with glutaraldehyde using special patterns. To select a template, the inter-commissural distance is measured in each leaf using special meters [1]. This technology for the treatment of blemishes does not require lifelong administration of anticoagulants and at the same time the neo-valve is less susceptible to degenerative changes, unlike a bioprosthesis. However, the method is not without drawbacks, the main one is an increase in the time of cardiopulmonary bypass and clamping of the aorta due to the difficulty of cutting out neoplasms from the autopericardium and the need for an additional skill of their implantation into the aortic position.

It is known a holding device that allows you to form a valve blank of three xenopericardium flaps and place them in the aortic position using the implantation technique of a conventional frameless bioprosthesis [2].

The disadvantage of this device is the long formation time of the valves due to the need for the formation of the cuff, it requires additional calibers to measure the fibrous ring of the aortic valve.

An adequate prototype was not found in the analyzed patent and medical literature

The objective of the present invention is to develop a device that allows you to form a new aortic valve of the heart by creating neoplasms from the autopericardium.

The problem is solved by creating a device containing a holding part, a washer and a working part. The holding part is made in the form of three metal knitting needles soldered at the proximal end and ending with a handle. The washer is put on knitting needles through three holes with the possibility of free movement from the proximal end of the retaining part to the distal end. The working part is located at the distal end and consists of three parts. Each of the three parts is made in the form of a sine of the lunar valve and is rigidly fixed on the spokes with the possibility of opening when moving the washer to the proximal end and closing when moving the washer to the distal end. The device fixes the pericardium as a collet clamp when moving the washer to and from the working part. When moving the washer from the working part, the three parts of which it consists, diverge, forming gaps. When the washer is moved to the working part, the three parts of which it consists are compressed. Additionally, when closed, the proposed device is a caliber for measuring the fibrous ring of the aortic valve. To work, you need a set of devices with a diameter of the working part from 19 to 27 mm, to select the right size depending on the diameter of the fibrous ring of the patient’s aortic valve. The technique of creating new aortic valve flaps is simplified, which reduces the time of surgery.

The device can be made of any durable and stable material in antibacterial treatment, including stainless steel grade 12X18H10T. Details of the working part of the device and the washer can be made of polymer, including PLA plastic.

The essential features characterizing the invention showed in the inventive combination new properties that are not explicitly derived from the prior art in this field and are not obvious to a specialist.

An identical set of features was not found in the study of patent and medical literature.

The proposed device can be used in practical health care to improve the quality and effectiveness of treatment, provide a quick cutting nevostok, their convenient fixation in the formation of a new aortic valve of the heart.

In FIG. 1 shows the proposed device: 1A, where 1 is the handle, 2 is the knitting needles, 3 is the washer, 4 is the working part: 1B, where 5 is the part, the three parts of the working part are closed.

In FIG. 2 shows the proposed device: 2A, where 1 is the handle, 2 is the knitting needles, 3 is the washer, 4 is the working part: 2B, where 5 is the part, three details of the working part are disclosed.

The invention will be clear from the following description and the figures attached to it.

The proposed device (Fig. 1) consists of a holding part made in the form of three metal spokes 2, brazed at the proximal end and ending with a handle 1, washers 3, worn on the spokes 2 through three holes in the washer with the possibility of free movement from the proximal end to the distal the end, the working part 4 at the distal end, consisting of three parts 5, rigidly fixed on the spokes 2 with the possibility of opening when moving the washer 3 to the proximal end and closing when moving the washer 3 to the distal end, each of the parts 5 is made in the form of a sine lunar valve.

Proposed as an invention, the device operates as follows:

The operation is performed under endotracheal anesthesia. After twice processing the surgical field with an antiseptic, a soft tissue incision is made along the midline on the chest. Median sternotomy is carried out in the accepted way. After visualization of the anterior mediastinum, 3 flaps of the pericardium are cut out and treated in 0.6% glutaraldehyde according to the accepted procedure. Simultaneously with the processing of the pericardium, the heart-lung machine is connected according to the “right atrium-aorta” scheme. After clamping the aorta and conducting myocardial protection by cardioplegia, a transverse aortotomy is performed 1 cm above the mouth of the right coronary artery. The altered valve is dissected, and using the proposed device in the closed position (Fig. 1), the washer 3 is shifted to the working part 4 and the necessary device size is selected, which corresponds to the size of the patient’s aortic root. Three previously prepared autopericardial flaps are fixed in a device of a suitable size: the washer 3 is moved from the working part 4 to the proximal end of the proposed device (Fig. 2), while the three parts 5 of the working part 4 are opened, the prepared pericardium is inserted into the obtained intervals, then the washer 3 is moved to the working part 4 (Fig. 1) while the three parts 5 of the working part 4 are closed, fixing the pericardium. Excess pericardium is removed, retreating from the 2-Zmm device, 3 / 0-4 / 0 polypropylene monofilament thread fixes along the commissures. The washer 3 is moved in the proximal direction from the working part 4 and the parts 5 are opened (Fig. 2) and the blank for the neo-valve is released. Next, the preform is implanted with a continuous twisting seam of polypropylene monofilament thread 4 / 0-5 / 0 in the aortic position. The aorta is sutured in a convenient manner. Conduct generally accepted measures for the prevention of air embolism. Remove the clamp from the aorta. To control the quality of reconstruction of the aortic valve, intraoperative transesophageal ultrasound of the heart can be used. They stop the cardiopulmonary bypass, produce a decanulation. Metal osteosynthesis is carried out by a convenient method. The wound is sutured in layers.

Clinical example.

Patient N, 71 years old, with a diagnosis of

Primary: Degenerative aortic valve disease: stenosis with a gradient of 129/87 mm Hg Hemodynamic angina pectoris.

Complication of the underlying disease: CHF stage I, FC II (NYHA).

Background disease: Stage 2 hypertension, drug correction of blood pressure. Risk 4.

Associated: Artifakia of both eyes (2010). Hernioplasty on both sides (2014).

Echocardiographic examination showed calcification of the fibrous ring of the aortic valve, the process partially goes to the aortic wall, pronounced fibrocalcinosis of the valves, the valves are spliced by commissures, the peak valve gradient is significantly increased 129 mmHg, average 87 mmHg, regurgitation 1 degree. The remaining valves without structural changes, function normally. According to coronarography, atherosclerotic lesions of the coronary arteries were not detected.

A decision was made to perform surgical treatment in the volume of aortic valve surgery using an autopericardium. Access to the heart is performed using sternotomy. Cut 3 flaps of the pericardium and processed in a 0.6% solution of glutaraldehyde according to the accepted method. The heart-lung machine was connected, the main stage of the operation was started. The aortic valve is excised. Using the proposed device in the closed position (Fig. 1), the washer 3 is shifted to the working part 4, the required device size corresponding to the size of the patient’s aortic root is 23 mm. Three previously prepared patches from the autopericardium are fixed in the device 23 of size: the washer 3 is moved from the working part 4 to the proximal end of the proposed device (Fig. 2) while the three parts 5 of the working part 4 are opened, the prepared pericardium is inserted into the gaps, then the washer 3 is moved to the working part 4 (Fig. 1) while the three parts 5 of the working part 4 are closed, the pericardium is fixed. The excess pericardium was removed with a 2 mm indent from the device, with polypropylene monofilament thread “Prolene 4/0” fixing sutures were placed along commissures. The washer 3 was moved in the proximal direction from the working part 4, parts 5 were opened (Fig. 2) and the blank for the neo-valve was released. Next, the preform was implanted with a continuous twisting seam of polypropylene monofilament thread “Prolene 5/0” in the aortic position. The aorta is sutured with a two-row (continuous U-shaped and continuous twisted) suture (Premilene 4/0 thread) on the pads, with deaeration of the left heart at the last sutures.

Measures to prevent air embolism. Clamp removed from the aorta. Cardiac activity recovered on its own. Measures to prevent air embolism. IR stop. To control the quality of the new aortic valve, an intraoperative transesophageal ultrasound examination of the heart was performed: the valves are functioning normally, there is no regurgitation, the gradient is 14/7 mm Hg. Decanulation. Hemostasis. A pair of electrodes is hemmed to the front wall of the right ventricle. Sternum osteosynthesis with 8 separate wire ligatures. Layer-by-layer suturing of soft tissues. Aseptic semi-alcohol dressing.

The device was tested during aortic valve reconstruction operations in 3 patients with isolated degenerative aortic valve disease. According to an echocardiographic study, all patients prior to surgery revealed high average and peak gradients, the sizes of the fibrous ring of the aortic valve varied from 21 to 25. All patients underwent isolated reconstruction of the aortic valve using devices of different sizes (21 mm, 23 mm, 25 mm). Anesthetic management was the same in all patients. All patients had access to the heart using median sternotomy, the operation was performed on the background of cardiopulmonary bypass and cardioplegia with the drug Custodiol. In the control echocardiographic study after surgery, all patients have a neo-valve that functions normally - there is no regurgitation, pressure gradients are within physiological values.

The use of the device proposed as an invention allows for the efficient and safe formation of a new aortic valve from an autopericardium.

Bibliography:

1. Ozaki S., Kawase I., Yamashita H. et al. Aortic valve reconstruction using self-developed aortic valve plasty system in aortic valve disease. Interact Cardiovasc. Thorac. Surg. 2011; 12: 550-553

2. Nesmachny A.C., Kareva Yu.E., Ruzmatov T.M., Chernyavsky A.M. “Plastic surgery of aortic valve cusps with a xenopericardial flap using a holding device as an alternative to aortic valve prosthetics”, Circulatory pathology and cardiac surgery. 2016.V. 20. No. 2. S. 58-65

Claims (1)

A device for forming the aortic valve of the heart, consisting of a holding part made in the form of three metal spokes soldered at the proximal end and ending with a handle, a washer worn on the spokes through three holes in it with the possibility of free movement from the proximal end to the distal end, working parts at the distal end, consisting of three parts, rigidly fixed on the knitting needles with the possibility of disclosure when moving the washer to the proximal end and closing when moving the washer to the distal end, each of the parts is made in the form of a sine of a lunar valve.

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