Articulation member for use in a surgical apparatus

Surgery – Specula – Retractor

Reexamination Certificate

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Details

C600S234000

Reexamination Certificate

active

06648818

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to the field of cardiac surgery instrumentation and more specifically to the surgical method and apparatus optimized for coronary bypass operations.
BACKGROUND OF THE INVENTION
Direct coronary artery revascularization on a beating heart was conducted, both experimentally and clinically, in the 1950's and the 1960's, without stabilization.
Challenges associated with this surgical technique are as follows:
complete anastomosis is very difficult to achieve due to the motion of the beating heart;
the technique is limited to vessels of a minimum diameter—again due to difficulty in the anastomosis technique on a beating heart;
lifting of the heart for revascularization of posterior arteries results in a precipitous drop in arterial pressure;
the learning curve for surgeons performing this technique is very high; negotiating the learning curve may represent significant surgical morbidity and mortality.
The development of the cardio-pulmonary machine for extracorporeal circulation (ECC) enables coronary operations on an arrested heart. This allows the surgeon to operate on a perfectly still heart and to manipulate the heart to expose the target artery.
At the present time, the standard coronary artery bypass graft (CABG) procedure typically requires a full median sternotomy and extracorporeal circulation through a cardio-pulmonary machine.
Even with the constant technological improvements achieved during the last twenty-five years, the advantages offered with ECC have been offset by morbidity and mortality related to the ECC itself. The inflammatory response, as well as systemic. microembolisms generated by ECC, induce to some extent a dysfunctional state of the brain, lungs and kidneys, which tends to increase with the aging of the patient. Furthermore, evidence suggests that when ECC can be avoided, the left ventricular function is better preserved, thereby reducing risk of post-operative complications.
As a result, alternate CABG procedures that do not rely on the use of ECC offer distinct advantages.
Recently, minimally invasive surgery, involving a partial sternotomy or mini-thorocotomy, has generated much interest since it removes precisely the need for ECC. This surgery does, however, have its limitations. It is adequate for only one or two coronary bypass grafts. Moreover, it does not provide access to the posterior descending or circumflex arteries, and impairs both the anastomosis and the surgeon's vision due to the limited heart exposure.
These limitations may lead to future, more-invasive surgical interventions through partial or full sternotomy, if “blockages” progress in those arteries which were not accessible via minimally invasive procedures.
Therefore, partial revascularization may lead to re-intervention which not only represents a disadvantage to the patient but a financial burden to the health care system.
SUMMARY OF THE INVENTION
It is therefore an object of the present invention to provide a surgical apparatus allowing to perform coronary surgery, in particular coronary artery revascularization, without the need for extra-corporeal circulation.
It is a further object of the invention to provide a surgical apparatus to perform complete revascularization of coronary arteries without the need for extra-corporeal circulation.
It is a further object of the invention to provide a surgical apparatus for performing coronary surgery, in particular coronary artery revascularization, on a beating heart.
It is a further object of the invention to provide a surgical apparatus for performing coronary surgery, in particular coronary artery revascularization, enabling grafting on all arteries of the heart and their respective branches, most particularly the right coronary (RC), the posterior descending artery (PDA), the left anterior descending artery (LAD) and diagonals, the branches of the circumflex artery (Cx) namely the obtuse marginal (1 through 4) and the postero-lateral branches.
It is a further object of the invention to provide a surgical apparatus for performing coronary surgery, in particular coronary artery revascularization, provided with positioning means being capable of being mounted in a plurality of locations on a sternum retractor or any other adequate support.
It is a further object of the invention to provide a surgical apparatus for performing coronary surgery, in particular coronary artery revascularization, simplifying the grafting process.
It is a further object of the invention to provide a surgical apparatus for performing coronary surgery, in particular coronary artery revascularization, with reduced costs associated with shorter time of surgery, reduced costs of surgical equipment, reduced surgical staff, significantly reduced risk of medical complications, and shorter hospital recovery stay.
It is a further object of the invention to provide a surgical apparatus for performing coronary surgery, in particular coronary artery revascularization, that is easy to utilize for surgeons and representing an evolution of current proven practice without the need for long retraining period.
It is a further object of the invention to provide a surgical apparatus for performing coronary surgery, in particular coronary artery revascularization, enabling surgeons to operate on all patients, especially those not well suited to minimally invasive techniques or well suited to conventional coronary artery bypass grafting (CABG) with extra corporeal circulation (ECC).
It is a further object of the invention to provide a surgical apparatus for performing coronary surgery, in particular coronary artery revascularization, with a risk reduced procedure for the patient, a cost effective solution to reducing health care expenses, and an ergonomic layout enhancing the efficiency of surgeons.
It is a further object of the invention to provide a surgical apparatus for performing coronary surgery, in particular coronary artery revascularization, that is ergonomic, easy to deploy, easy to sterilize, and time efficient with respect to the multitude of attachments which might be needed during the course of open chest surgery.
It is a further object of the invention to provide a surgical apparatus for performing coronary surgery, in particular coronary artery revascularization, which optimizes accessibility to all different arteries requiring grafting irrespective of variations in personal physiology from one patient to another.
It is a further object of the invention to provide a surgical apparatus for performing coronary surgery, in particular coronary artery revascularization, that can be used with known types retractors, as a retrofit arrangement.
Another object of the invention is to provide positioning means for a surgical apparatus, in particular a heart stabilizer for performing coronary surgery, particularly coronary artery revascularization, without the need for extra-corporeal circulation.
Another object of the invention is to provide contacting means for a surgical apparatus, in particular a heart stabilizer for performing coronary surgery, particularly coronary artery revascularization, without the need for extra-corporeal circulation.
Another object of the invention is to provide a sternum retractor for performing coronary surgery, particularly coronary artery revascularization, without the need for extra-corporeal circulation.
As embodied and broadly described herein, the invention provides a surgical apparatus for coronary surgery on a patient comprising contacting means being capable of providing a mechanical force against at least a portion of the patient's coronary organs according to its positioning with regard to said organs, positioning means to set said contacting means in a given substantially stable spatial position and orientation within a given volume, said contacting means being pivotingly connected to a sternum retractor via said positioning means.
This surgical apparatus enables performing coronary surgery, particularly coronary artery revascularization, without the need for extr

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