Surgery – Instruments – Electrical application
Reexamination Certificate
2002-04-03
2003-04-22
Gibson, Roy D. (Department: 3739)
Surgery
Instruments
Electrical application
Reexamination Certificate
active
06551314
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to medical apparatus and methods. More particularly, the present invention relates to methods and systems for intraluminal vein harvesting or removal.
Cardiac and peripheral vascular bypass surgery commonly employs veins harvested from the patient undergoing surgery, usually obtained by autologous vein harvesting procedures. Vein harvesting commonly relies on making a long skin incision to expose the length of vein which is to be excised and removed. Such exposure of the vein allows for dissection and division of the veins which branch from the portion of vein being removed. The greater saphenous vein in the leg is most commonly used, followed by the lesser saphenous vein in the leg and the basilic and cephalic veins in the arm.
Such long incisions made for vein harvesting are highly traumatic and problematic for a number of reasons. First, patients requiring bypass surgery often suffer from other diseases, such as diabetes, obesity, malnutrition, which may impede healing and increase the risk of infection of the skin incisions. Additionally, the cosmetic scarring which results from the long incisions is of concern to many patients.
To partly overcome these drawbacks, systems for the endoscopic harvesting of veins have been developed. Such systems, presently available from suppliers such as Ethicon and General Surgical Innovations, rely on introduction of endoscopic apparatus through an incision at one end of the vein segment to be removed. The apparatus includes a viewing scope, a mechanism for dissecting the vein from the surrounding tissue bed, and additional mechanisms for dissecting the vein from side branches to facilitate removal. Other systems, such as that available from Guidant Corporation, use gas insufflation to create a working space around the vein and rely on percutaneously introduced instruments for excising the vein. In all cases, the systems are expensive, cumbersome to use, and still traumatic to the patient.
For these reasons, it would be desirable to provide improved vein harvesting apparatus and methods for their use, which are minimally traumatic to the patient, which do not require long skin penetrations or incisions at points between the two ends of the vein segment being removed, which permit selective excision of the venous side branches and optional sealing of the side branches, and which provide a vein segment which is maintained relatively intact allows for valve removal and which can be used for bypass grafting or other purposes with minimal additional preparation. It would be further desirable if the systems and methods were also useful for vein stripping and removal for treatment of varicose veins and other conditions. The system and methods should optionally permit endoscopic visualization of the vein while it is being removed and remove relatively long vein segments with a single device deployment. At least some of these objectives will be met by the inventions described hereinafter.
2. Description of the Background Art
Intraluminal vein removal and modification devices are described in U.S. Pat. Nos. 6,165,172; 6,030,396; 6,013,073; 5,843,104; 4,528,982; 3,788,325; 3,568,677; 3,185,155; 3,045,676; 2,770,334; and PCT Publication WO 00/45691. Endoscopic and extraluminal vein removal devices are described in U.S. Pat. Nos. 6,022,313; 5,817,013; 4,793,346; and Re. 36,053. Patents relating to vein harvesting assigned to General Surgical Innovations include U.S. Pat. Nos. 6,196,968; 6,077,289; 6,068,639; 5,993,412; 5,968,066; 5,944,734; 5,899,913; and 5,853,417. Patents relating to vein harvesting assigned to Ethicon include U.S. Pat. Nos. 6,193,653; 5,928,138; 5,922,004; 5,902,315; and 5,667,480.
BRIEF SUMMARY OF THE INVENTION
The present invention provides improved methods, systems, and kits for removing veins from their surrounding tissue beds. While the methods will find their greatest use in the harvesting of veins for subsequent implantation in bypass and other procedures, they will also find use for removing varicose veins and diseased veins for cosmetic and other purposes. When used for vein harvesting, the target veins will most often be the greater saphenous vein or the lesser saphenous vein in the leg, and the basilic and cephalic veins in the arm.
The present invention is advantageous in a number of respects. It does not require a long incision along the length of the vein segment to be removed. Instead, it is less invasive and may be performed via surgical cut downs at each end of the vein segment to be removed. Additionally, the present invention allows for selective severing of venous side branches from the vein segment being removed during the removal process. In one embodiment of the present invention, such selective severing (and optionally subsequent sealing) of the side branches may be performed under direct endoscopic visualization. In another embodiment, such selective severing is achieved in a blind fashion, greatly simplifying the protocols. Use of the methods and apparatus of the present invention has been found to produce very long and high quality vein segments suitable for coronary artery and other bypass and implantation procedures. In some embodiments, the apparatus of the present invention facilitates manipulation of the long vein segments after they have been removed, in particular allowing trimming of the valves and other preparation steps to be performed while the vein remains over a long distal portion of the vein removal catheter.
In a first aspect, methods according to the present invention for vein removal comprise exposing first and second spaced-apart locations along a vein, typically by surgically exposing the locations, commonly referred to as a surgical cut down. The veins are then transected at each of the locations so that a segment of the vein is isolated and ready for removal from the surrounding tissue bed. The remaining portions of the vein, i.e., those which are not to be removed, may have their free ends tied off or otherwise sealed.
After exposing and transecting the ends of the venous segment to be removed, a guidewire is passed through a lumen between the first and second locations. The length of the guidewire is sufficient to permit introduction of intraluminal devices over at least one end, and preferably over both ends, of the guidewire to perform the methods described herein. In particular, a pull catheter will be introduced over the guidewire from the first location until a distal end of the pull catheter reaches the second location. Usually, the first location will be that which is closest to the patient's heart and which therefore has a larger diameter.
Alternatively, the pull catheter may have a fixed rail at its distal end or the pull catheter may be provided with a rail immobilization mechanism for selectively holding a movable rail with the distal end of the movable rail exposed distally out the pull catheter. In either case, the pull catheter may be introduced to and through the target vein without the prior positioning of a movable rail. With a fixed rail, the rail would be designed to be long enough to allow introduction of a side branch management catheter (as described below) excision or other catheter over a movable rail in a direction opposite to that of the pull catheter. An advantage of using a pull catheter and a fixed rail is that there is no need to separately manipulate a long guidewire, which when both a pull catheter and an side branch management tool are to be introduced, may have a length which is more than three times that of the individual catheters. A similar advantage is found with the use of the immobilized rail, where the rail could have a length only slightly longer than that of the pull catheter. The immobilized guidewire, however, could be released after the pull catheter is extended distally so that it could remain in place as the pull catheter is withdrawn from the vessel. An advantage of both these alternative rail designs, is that introduction of a side br
Hill Bradley
Holmbren Neil
Modesitt Bruce
Fogarty Thomas J.
Gibson Roy D.
Townsend and Townsend / and Crew LLP
Vrettakos Peter
LandOfFree
Methods and systems for vein harvesting does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Methods and systems for vein harvesting, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Methods and systems for vein harvesting will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3005945