WO2018094484A1

WO2018094484A1 - System for surgical treatment of heart valves to facilitate the task of performing an operation by organising the surgical threads and facilitating the surgical presentation of the structures of the heart to be treated

Info

Publication number: WO2018094484A1
Application number: PCT/BR2016/000141
Authority: WO
Inventors: Mário César SANTOS DE ABREU
Original assignee: Santos De Abreu Mario Cesar
Priority date: 2016-11-23
Filing date: 2016-11-25
Publication date: 2018-05-31
Also published as: BR102016027541A2

Abstract

The invention patent describes a "system for surgical treatment of heart valves to facilitate the task of performing an operation by organising the surgical threads and facilitating the surgical presentation of the structures of the heart to be treated". This surgical instrument is an accessory device for cardiovascular surgery for use during heart surgery, since, during operations involving heart valves - the mitral, aortic and tricuspid valves - the valve replacement procedure, i.e. the moment when a prosthetic valve for treating the insufficiency of a valve is implanted, it is necessary to use a large number of surgical threads for securing the prosthesis in the valve ring in such a manner as to prevent retrograde blood leakage.

Description

SURGICAL TREATMENT SYSTEM FOR HEART VALVES TO EASILY THE OPERATING ACT ORGANIZING SURGICAL WIRE, EASYING THE SURGICAL PRESENTATION OF THE HEART STRUCTURES TO BE TREATED

SHORT PRESENTATION

[001] The present invention describes the Cardiovascular Surgery Auxiliary Device (AACCV) - CARDIO-CARROUSEL, which is a surgical instrument to be used during cardiac surgeries, especially valvular surgeries. heart valve, mitral, aortic and tricuspid valve operations, the valve replacement procedure, that is, when a valve prosthesis is implanted to treat valve incompetence, the use of a large number of surgical wires is necessary to fix the prosthesis in the valve ring so as not to allow blood to escape retrograde.

In these surgeries several separate stitches are used ranging from a minimum of 12 threads to 18 or more than twenty threads. These wires, after being fixed in the valve ring, must be fixed in the surgical field in an organized manner, and arranged so as to be subsequently fixed and tied keeping the prosthesis in proper position, without possibility of reflux or detachment of the valve ring.

Thus (AACCV) the CARDIO-CARROUSEL during this operation, becomes of great importance during these surgeries interfering in the systematization of the operation making the procedure very simple and agile allowing the easy integration of team components, as well as synchronization, reducing up to 3 times the time required for valve replacement. The average time is between 40 and 80 minutes sometimes even longer, but with the AACCV - CARDIO-CARROUSEL, we reach 12 to 20 minutes, time required for valve replacement.

[0001] This surgical instrument makes it possible to maintain the arrangement of the wires in an orderly manner, to support the fixation of different types of prostheses, to facilitate the passage of surgical wires by fixing: and keeping traction surgical structures (anatomical repairs) such as borders of the atria, ventricles, aorta, pulmonary artery, allowing the necessary exposure of the heart valves.

In addition to these functions, the instrument serves as an aid in measuring angles, facilitates the marking of valvular commissures of importance in the positioning of heart valves, allows different traction on the edges of the structures. Still finds application in the training rooms of surgeons serving as support for the use of hearts to train surgeries such as valvular plastics, and especially valve replacements.

APPLICATION FIELD

[006] The present invention will be applied in the area of cardiac surgeries, especially valvular surgeries, with the main purpose of facilitating these surgeries, because during the operations of cardiac valves, mitral, aortic and tricuspid, it is necessary to use a large number of surgical threads. for fixation of the prosthesis in the valve ring so as not to allow retrograde blood to escape, also preventing wire entanglements, and fixation of structures. TECHNICAL STATE

Annually experts nationally and internationally come together to discuss to discuss advances in the surgical chartering of heart valve diseases. These advances will influence the new techniques of cardiac valve replacement, allowing a better evolution of patients from the general point of view, often clearly interfering with mortality and morbidity rates.

Therefore, the creation of surgical instruments that allow the handling of cardiac structures with lower operative risk will help the surgery and will influence a chain of events since the patients' hospitalization time, exposure to risks during hospitalization, shorter time of surgery. cardiac arrest, significantly reducing operative risk, and complications related to length of hospital stay, such as the risk of nosocomial infections, bleeding from coagulopathies, and even cardiac function.

[009] The subject is quite complex and the constant updating of the surgical techniques of cardiac valve treatment positively influences the operative results. Therefore surgeons must be up to date in order to be able to use more and more advanced resources to treat patients, especially heart disease. Thus during the congresses the experts put their opinions, their techniques, and results.

Comparing the invention with the state of the art

[010] The present invention deals with the technique of performing cardiac valve replacement, bringing as its main advantage the organization of surgical threads during valve replacement surgeries, preventing thread entanglements, and speeding up the operative act.

[011] In this area rheumatic heart disease that clearly interferes with heart valve health is still very common. Patients suffering from rheumatic disease outbreaks end up with complications of the inflammatory process generated in the heart and mainly affecting the heart valves. This inflammatory process will lead to valvular disease (mitral, aortic and tricuspid), making the number of cardiac operations for surgical treatment of the aortic and tricuspid mitral valves still very common, despite advances in minimally invasive techniques.

[012] All advances in surgical technique and understanding of the pathophysiology of heart valve dysfunction have led to better results. Seen as a development beyond morbidity and mortality measures, health-related quality of life outcomes (HRQoL) measures are becoming increasingly popular. These measures are important because complications from routine (ie, low-risk) mitral valve operations are uncommon and other outcome markers are required.

[013] Surgeons are increasingly operating on asymptomatic patients and will need to prove that HRQoL is not impacted. New minimally invasive and transcatheter technologies will also need to demonstrate satisfactory HEALTH RELATED QUALITY OF LIFE (HRQOL) results before widespread use.

[014] This systematic review (Tan MKH, Jarral OA, Thong EHE, Kidher E, Uppal R, Punjabi PP et al. Quality of life after mitral valve interventional Interact CardioVasc Thorac Surg 2016; doi: 10.1093 / icvts / ivw312), provides an overview of all available literature detailing HRQOL in patients receiving mitral valve interventions. In the 43 included studies, 6865 patients underwent procedures ranging from open replacement to percutaneous repair using devices such as MitraClip Clip Delivery System (Abbott Vascular, Santa Clara, CA). USA). Most studies performed baseline HRQoL assessment, allowing for postoperative comparison.

[015] Although the underlying literature has deficiencies, most studies have acceptable post-intervention HRQoL that is comparable to that of corresponding general populations. Patient-specific factors (eg female gender, renal dysfunction) and specific surgical factors (eg replacement rather than repair, high transmission gradient) were identified that predispose patients to poorer long-term HRQoL results. These factors are important for clinicians developing strategies to maximize their HRQoL results.

Future randomized trials would benefit from HRQOL measurements at specific time points to allow for large-scale comparisons. The establishment of a common HRQoL instrument for use in mitral valve intervention studies may support detailed comparisons between specific techniques. Physical activity monitors, physiological biomarkers and radiological markers could also be used as innovative indicators of functional outcome.

OF THE INVENTION

[017] The present invention is a device for assisting during the cardiac valve replacement procedure. The assistive device for cardiovascular surgery consists of a stainless steel rim to be placed on the patient's chest during valve replacement surgery.

[018] At the top of the rim, 12 steel springs made of 1mm diameter steel, 6mm outside diameter, 4mm inner diameter, and 42.5mm overall length are attached. The springs are attached at their ends to the ring with steel rivets through holes that secure the horizontal ring of the springs to the surface of the rim. Each spring has 02 steel rivets securing them to the rim, one at each end of the spring. The spacing of the springs is 14 mm.

[019] The steel rim is the basis for the springs and is made up of a 2.5 cm wide stainless steel circle with an inner diameter of 20 cm. and outside diameter and 25 cm. So the steel disc is 5 cm wide. On the outer edge of the steel rim marks are printed with graduation every 2.5 degrees, marks printed at 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180.195, 210, 225, 240, 255, 270, 285, 300, 315, 330, 345, 360 degrees.

[0201 Springs attached to the circumference of the circle have equidistant marks every 30 degrees on the outside. Near the edge, springs were fixed, arranged at intervals of 30 degrees, as auxiliary devices for fixation of surgical wires, and intermediate marking at the 30 degree points. Thus, we have points marked throughout the circle, equidistant of 15 degrees. In four (04) of these points, we have four holes, two (02) for fixing the metal nails, where the prostheses to be implanted can be fixed, such as for example, in aortic valve changes, where the prosthesis is fixed with the valve hofder, dispensing the first helper from holding the prosthesis in position for the passage of wires for attachment to the aortic ring. Two holes will be used to fix the instrument in the surgical field.

[021] It is a surgical instrument to be used during cardiac surgeries, especially valvular surgeries, with the main purpose of facilitating these surgeries, because during the operations of cardiac valves, mitral, aortic and tricuspid, the procedure of valvular juncture, that is. When a valve prosthesis is implanted to treat valve incompetence, a large number of surgical wires are required to fix the prosthesis to the valve annulus so that blood cannot escape retrograde. These strands after tying will fix the prosthesis in the respective ring (mitral, aortic, tricuspid).

[022] In these surgeries several separate stitches ranging from a minimum of 12 threads to 18 or more than twenty threads are used. These wires, after being fixed in the valve ring, must be fixed in the surgical field in an organized manner, and arranged so as to be subsequently fixed and tied keeping the prosthesis in proper position.

[023] Thus, the AACCV - CARDIO-CARROUSEL during this operation, becomes an important instrument in these surgeries interfering in the systematization of the operation taking the very simple procedure and allowing easy integration of team components, as well as synchronization, and agility of the procedure, reducing up to 3 times the time required for valve replacement.

[024] This surgical instrument makes it possible to maintain the arrangement of the wires in an orderly manner, to support the fixation of different types of prostheses, to facilitate the passage of surgical threads, fixing and keeping traction surgical structures (anatomical repairs) such as borders of the atria, ventricles, aorta, pulmonary artery, allowing the necessary exposure of the heart valves.

[025] In addition to these functions, the instrument serves as an aid in measuring angles, facilitates marking of valvular commissures of importance in the positioning of heart valves, and allows for different traction at the edges of structures. Still finds application in the training rooms of surgeons serving as support for the use of hearts assisting in the training of cardiac surgeries such as valvular plastic, and valve replacement mainly.

DESCRIPTION OF THE FIGURES

[026] The objects and advantages of the present invention will become more apparent from the following detailed description of an exemplary embodiment of the invention and accompanying drawings by way of non-limiting example, wherein:

FIG. 1 illustrates the bolt-free rim (CARDIO-CARROUSEL) containing 4 holes for the holder shanks, marking the angles on the outer edge and clamp on the underside to secure to the surgical field;

FIG. 2 illustrates the 1 - Stems and 2 - Holder over the prosthesis fixation ring that will be sutured in the valve ring, holder that positions it correctly to suture it and fit it correctly in the aortic ring;

FIG. 3 illustrates the prosthesis attached to the aortic ring.

Claims

1) SYSTEM AND SURGICAL TREATMENT OF HEART VALVES TO FACILITATE THE OPERATING ACT ORGANIZING SURGICAL WIRE, FACILITATING THE SURGICAL PRESENTATION OF THE HEART STRUCTURES TO BE TRADED FOR THE MAIN OPERATION OF THE CARDIAC VALVE facilitate these surgeries.

2) SURGICAL TREATMENT SYSTEM OF HEART VALVES TO EASILY THE OPERATING ACT ORGANIZING SURGICAL WIRES, EASYING THE SURGICAL PRESENTATION OF THE HEART STRUCTURES TO BE TREATED, according to the aforementioned surgery for the use of cardiac surgery to assist the surgery. to be placed on the patient's chest during valve replacement surgery.

3) SURGICAL HEART VALVE TREATMENT SYSTEM TO EASILY THE OPERATING ACT ORGANIZING SURGICAL WIRES, EASYING THE SURGICAL PRESENTATION OF THE HEART STRUCTURES TO BE TREATED, according to claim 1 to steel, It consists of a circle of stainless steel, 2.5 cm wide, with an inner diameter of 20 cm, and an outer diameter of 25 cm. So the steel disc is 5 cm wide. On the outer edge of the steel rim, marks are graduated every 2.5 degrees, marks printed at 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180,195, 210, 225. , 240, 255, 270, 285, 300, 315, 330, 345, 360 degrees.

4) SURGICAL HEART VALVE TREATMENT SYSTEM TO EASILY THE OPERATING ACT ORGANIZING SURGICAL WIRES »EASYING THE HEART STRUCTURES TO BE TREATED, according to claim 1, which are in accordance with claims 1 and 2, which are in accordance with claims 1 and 2. steel rivets through holes that secure the horizontal spring ring to the rim surface, with 2 steel rivets fastening them to the rim, one at each end of the spring, with spring spacing of 14 mm.

5) SURGICAL TREATMENT SYSTEM FOR HEART VALVES TO EASILY THE OPERATING ACT ORGANIZING SURGICAL WIRE, EASYING THE SURGICAL PRESENTATION OF THE HEART STRUCTURES TO BE TREATED, DETERMINED BY THE CIRCUMSTANCES OF 1 In four (04) of these points, we have four holes, two (02) for fixing the metal nails, where the prostheses to be implanted can be fixed.

6) SURGICAL TREATMENT SYSTEM FOR HEART VALVES TO EASILY THE OPERATING ACT ORGANIZING SURGICAL WIRES, EASYING THE HEART STRUCTURES TO BE TREATED, according to claim 4, two of which are for the treatment of two, 1, 2, 3 where the prostheses to be implanted in the aortic valve replacements can be fixed, in which the prosthesis is fixed with the valve holder, dispensing or facilitating the first assistant's job of keeping the prosthesis in position for the passage of the wires for fixation in the aortic ring in the aortic ring. Two holes will be intended for affixing the instrument in the surgical field.