Surgery – Instruments – Surgical mesh – connector – clip – clamp or band
Reexamination Certificate
2000-03-07
2002-12-03
Jackson, Gary (Department: 3731)
Surgery
Instruments
Surgical mesh, connector, clip, clamp or band
C606S139000
Reexamination Certificate
active
06488692
ABSTRACT:
TECHNICAL FIELD OF THE INVENTION
The present invention relates to the general art of surgery, and to the particular field of minimally invasive surgery.
BACKGROUND OF THE INVENTION
As discussed in the incorporated documents, there is current interest in surgical techniques that are less invasive than previous techniques. This current interest has engendered interest in many areas that were previously abandoned including coronary fastening and valve placement among other areas that will occur to those skilled in the surgical art.
Furthermore, many of these procedures include use of cardiopulmonary bypass for their execution. Cardiopulmonary bypass removes the venous blood from the heart and returns it to the circulation system of the patient through the patient's aorta or through one of its branches after it has been oxygenated. This bypass procedure makes it possible to remove the heart from the circulation system in order to perform corrections on the heart and also makes it possible to arrest the heart so that there is a non-moving field that is relatively free of obstructions for the surgeon to work.
Numerous surgical procedures such as the just-mentioned cardiopulmonary bypass procedures require cannulation of a hollow anatomical structure such as the heart, the great vessels associated with the heart as well as other internal organs during the course of surgical procedures. Venous cannulation (where unoxygenated blood is removed from the patient's circulation system) can be performed in the right atrium, SVC, IVC or other major venous branch. Typically, blood is removed from the right atrium by cannulas which have extensions into the SVC or IVC. A single cannula is sufficient for routine bypass procedures. Such a cannula typically has a basket-shaped area which sits in the right atrium and has an extension into the IVC. For valve procedures or in situations where it is necessary to totally exclude blood from the heart, it is necessary to drain blood from both the SVC and the IVC independently so that two cannulation sites and two cannulas are required.
Oxygenated blood is usually returned via the aorta (arterial cannulation site). This is usually accomplished with a single cannula of smaller diameter than the venous cannula since blood is pumped into the patient. The pumped blood distributes itself in the arterial system.
Cannulation sites are also necessary for other purposes. Cardioprotective solutions (cardioplegia) are often infused into the coronary arteries through the aortic root. Such solutions can also be delivered into the coronary sinus and used to perfuse the myocardium in a reverse direction (i.e., vein to myocardium to artery), which is also known as “retrograde cardioplegia.” Cannulation is also necessary when pressure or flow monitoring catheters are introduced into the heart or great vessels.
In short, cannulation is an essential component of many surgery procedures associated with a hollow anatomical structure such as the heart or blood vessels. Therefore, there is a need for efficient and effective means and methods for carrying out cannulation during a surgical procedure associated with a hollow anatomical structure and whenever cardiopulmonary bypass is necessary or whenever catheters or tubes must be inserted into the heart. This is especially so during minimally invasive surgery.
Many operations still require a considerable incision or port to conduct the operation, and many of these operations require hand suturing to perform the procedures. Smaller access sites must be used to effect truly minimally invasive procedures on patients. This necessitates technologies which obviate the need for suturing and other fine motor tasks which require direct visualization and hand suturing since the suturing will be difficult with the limited access associated with minimally invasive surgery.
Still further, general access restrictions make manipulations difficult and blood in the surgical field is also a cause for concern. Therefore, there is a need for providing a generally bloodless field when carrying out the steps associated with cannulation and subsequent closure of the cannulation incision. Furthermore, blood leakage may cause a problem. Therefore, there is a need for a cannulation means and method which can be carried out in minimally invasive surgery and which will minimize, if not totally eliminate, blood in the surgical field.
Since cannulation is an area which has heretofore required considerable hand suturing, there is a need for a cannulation device and method which requires only a minimal incision in the patient and eliminates the need for hand suturing. The device and any tools associated therewith could, for example, allow the cannulation of the heart by a tiny incision or port because no hand suturing would be necessary. During such a procedure, the patient could be placed on bypass by cannulas in the heart without the need for large incisions. Other examples of such nonhand sutured cannulation include procedures on any hollow anatomical structure, including blood vessels and other organs as will be known to those skilled in the medical art.
In addition to hand suturing techniques required by the prior art, the prior art discloses devices which incorporate a variety of balloon configurations which act to seal an incision site while cannulas are in place and which can also restrict the flow of blood to and through the structure, such as a major vessel. One problem with such devices is caused when the cannula is removed and the only way to re-establish patency of the vessels is to hand suture them closed. This method is not well suited to the small incisions used in minimally invasive surgery since hand suturing requires more room to manipulate tools and also to enable the surgeon to visualize what he or she is doing. Therefore, in addition to the needs discussed above, there is also a need for a device which can be placed in a patient without requiring hand suturing and which is suitable for use in minimally invasive surgery to meet these requirements as well.
In addition, older patients may have frail tissue which result in trouble pulling purse-string sutures tight. In some cases, the sutures will cut the tissue causing further leaks which must be patched and sutured again. Therefore, there is a need for a means and a method for setting a cannula in a patient who may have fragile and/or friable tissue, especially in minimally invasive surgery.
It is also noted that anchoring a cannula in tissue stresses that tissue by transmitting any forces associated with the cannula or movements of the cannula to the tissue. As is especially the case with frail tissue, such anchoring may tend to tear the tissue. Therefore, there is a need for a means and a method for attaching a cannula to an anatomical structure in a manner that reduces or eliminates cannula-induced stress on the tissue.
Closure of purse-string sutures causes the tissue to be gathered and bunched resulting in a loss of cross-sectional area and/or a decreased function. Therefore, there is a need for a means and a method for gaining access to the interior of an organ or a vessel that can be closed without causing bunching and/or gathering of the patient's tissue.
Still further, in manually sutured procedures a substantial amount of tissue is required to make a port closure. For example, when the atrium of the heart or the aorta is cannulated with a purse-string suture the tissue inside the purse string is lost when the suture is tied. This causes stretching and deformity of the heart or aorta when the purse-string is tied, sometimes leading to tears in the tissue and/or leaks. Therefore, there is a need for a means and a method for cannulating organs which does not require purse-string sutures.
Specifically, surgeries on many organs also require opening the organ and/or the vessels associated with therewith. The vessels must be closed at the end of the procedure to complete the operation. It is important to minimally invasive procedures to have a tool which will allow closure
Christakis George
Spence Paul A.
Williamson IV Warren P.
Jackson Gary
Origin Medsystems Inc.
Thelen Reid & Priest LLP
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