Surgery – Instruments – Cutting – puncturing or piercing
Reexamination Certificate
2000-02-23
2001-02-13
Buiz, Michael (Department: 3731)
Surgery
Instruments
Cutting, puncturing or piercing
C606S167000, C606S153000, C030S366000
Reexamination Certificate
active
06187022
ABSTRACT:
BACKGROUND OF THE INVENTION
1. The Field of the Invention
The present invention is directed generally to methods and apparatus for effectuating surgical incisions. More specifically, the present invention is related to methods and apparatus for effectuating precise and uniform incisions, including aortic incisions.
2. The Relevant Technology
Coronary artery bypass surgery is commonly required when coronary arteries narrowed by cholesterol-rich fatty deposits or plaques are unable to supply the heart muscle with a sufficient amount of blood, and as a result, the heart becomes starved for oxygen. Left untreated, coronary artery disease ultimately leads to acute myocardial infarction, commonly referred to as a heart attack. In coronary artery bypass surgery, a surgeon grafts a section of a healthy vessel, such as a portion of a saphenous vein, to bypass a stenotic or partially blocked portion of a coronary artery in order to ameliorate the oxygen access to the heart muscle.
Various techniques have been used to create the opening in the aorta, known as an aortotomy, to which the graft is sutured. Most aortotomies used for bypass grafts are created using a surgical scalpel in concert with an aortic punch. The surgical scalpel is used to make a linear incision in the aorta Then, a portion of the aortic punch known as the “anvil” is passed through the incision. The punch is then engaged creating an aortotomy.
Conventionally, in order for the anvil of the punch to pass through the linear incision, either the incision needs to be longer than the diameter of the anvil or the hole created by the incision needs to be stretched. When the incision is made longer than the punch diameter, lateral nicks in the circumference of the aortotomy are created. These lateral nicks necessitate either repunching the aorta to enlarge the aortotomy or special suturing to avert bleeding at the lateral incision sites. Alternatively, when the initial hole created by the incision is stretched, often by utilizing a dilator prior to inserting the punch, an irregular and unpredictable tearing of the aorta often occurs.
The brittle and fragile nature of the aorta in the average coronary artery bypass graft patient necessitates great care in dealing with the aortic wall. The problems associated with conventional aortotomies can cause major problems with bleeding, compromise of the anastomosis, or aortic dissection.
Similar problems exist with incisions made in other vessels and even other body organs. Therefore, it will be advantageous to provide an improved method and aparatus for performing improved incisions.
SUMMARY AND OBJECTS OF THE INVENTION
It is an object of the present invention to provide improved methods and apparatus for achieving precise and uniform surgical incisions.
It is another object of the present invention to provide improved methods and apparatus for providing aortotomies for coronary artery bypass grafts.
It is still another object of the present invention to provide improved methods and apparatus for providing aortotomies which do not require stretching or repunching.
These and other objects and features of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter.
The present invention is directed to a surgical knife which provides the unique feature of multi-sided incisions, for example, within an aorta for effectuating improved aortotomies. The surgical knife preferably includes a multi-bladed portion connected to a handle portion. The handle is sized and configured to maximize grip and surgical manipulation thereof. In one configuration, the multi-bladed portion extends to a sharpened distal point with a plurality of blade members radiating outwardly and proximally from the sharpened point. Each blade member is formed with a sharpened edge. A preferred surgical knife provides a substantially cruciate, or cross-shaped, incision with four sharpened blade members.
In a preferred embodiment of the present invention, the multi-bladed portion is formed from a primary blade and a secondary blade. The primary blade has a sharpened distal point and the secondary blade has a distal end. The primary and secondary blades are joined such that the distal end of the secondary blade is at a location spaced proximally from the sharpened distal point of the primary blade. The primary blade may be configured with two or more primary blade members, each formed with a sharpened edge. The primary blade members combine to form a sharpened distal point. The secondary blade may be formed from two or more secondary blade members which combine to form a distal end of the secondary blade.
The multi-bladed portion of the surgical knife may comprise three, four, five, six, or more blade members. It is currently preferred that the blade members form equal angles in radiation outwardly and proximally from the sharpened distal point such that, in the preferred embodiment, the surgical knife provides a substantially cruciate, or cross-shaped, incision with limited force applied by a user.
In a preferred method of the present invention, an appropriate site and size for an incision is determined. An appropriately sized surgical knife having a primary and a secondary blade of the present invention is obtained and then inserted perpendicularly into the predetermined site. In another preferred method of the present invention, an appropriately sized surgical or aortic knife is obtained and stabbed into a portion of an aorta or other vessel, or other body organ. An anvil of an aortic punch is then inserted into the incision, for example, in the aorta, a step that may be performed without the stretching necessitated by the conventional single linear incision. The punch is then centered and fired. The resulting aortotomy lacks the lateral nicks and aortic dissection associated with the prior art.
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Alexander, Jr. John C.
Swindle Carl A.
Buiz Michael
Edwards Lifesciences Corporation
Lewis William
Workman & Nydegger & Seeley
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