Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-05-17
2001-04-24
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06221063
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to an improved balloon catheter and, more specifically, to a catheter incorporating means adapted to prevent the sticking of the expandable member or balloon to the catheter. In another aspect, the invention relates to a catheter for use in coronary bypass surgery positioned externally of the heart and adapted to assist in the retention of a retrograde cardioplegia solution perfusion (“RCSP”) catheter in the coronary sinus.
2. Description of the Related Art
Catheters having an expandable member provided thereon have a wide variety of applications in numerous, different, medical procedures. One known structure for such a catheter comprises an expandable member or balloon provided on the outside surface thereof wherein the balloon is expandable between a retracted state and an expanded state. In the retracted state, the balloon can be a “tight-fitting” balloon which is inflated through the application of a pressurized fluid to the interior of the balloon. One problem inherent with such tight-fitting balloons is the uneven inflation of the balloon upon the application of a pressurized fluid to the balloon interior. In drastic cases, portions of the balloon remain tacked to the exterior surface of the catheter body when the balloon is in the fully-inflated position. This can result in the balloon, in the expanded shape, assuming an undesirable, unpredictable configuration. In addition, tacking of the balloon can result in excessive elongation of portions of the balloon body.
As noted above, balloon catheters have a wide variety of applications, only one of which is used during coronary bypass surgical procedures. Perfusion of a heart during coronary bypass surgery with cardioplegia solution can be performed retrograde, antigrade, or a combination of retro and antigrade. During the retrograde provision process a catheter is first typically inserted into the right atrium through an appropriate incision and then inserted through the ostia into the coronary sinus. Next, an expandable member, such as a balloon which is provided on the catheter, is inflated inside the coronary sinus to occlude this vessel. Cardioplegia solution is forced through the catheter into the coronary sinus to perfuse the heart tissue. Examples of known retrograde catheters are seen in U.S. Pat. No. 5,395,330 issued Mar. 7, 1995 to Marcadis et al. and U.S. Pat. No. 5,505,698 issued Apr. 9, 1996 to Booth et al.
One problem with the known RCSP process is possible movement or dislodging of the RCSP catheter from the coronary sinus as a result of the fluid pressure generated inside the coronary sinus. Excessive movement of the inflated RCSP catheter could result in leaking of cardioplegia solution from the coronary sinus back into the right atrium.
Another problem experienced by some patients during the retrograde perfusion process is insufficient perfusion of the heart tissue as a result of leaking of solution from the middle cardiac vein and the small cardiac vein back into the right atrium. When perfusion solution is allowed to drain from the veins back into the right atrium, the cardioplegia solution being perfused through the tissue will seek the path of least resistance and drain into these veins rather than completely perfusing the heart tissue.
SUMMARY OF THE INVENTION
The improved balloon catheter and method for using the same overcomes the problems of the prior art by providing means for preventing the inadvertent sticking or tacking of the inflatable member to the exterior surface of the catheter as the inflatable member is expanded. The catheter and method for using the same also overcomes the problems of the prior art by providing means for effectively sealing the middle and small cardiac veins during the retrograde perfusion process and also providing means for retaining the RCSP catheter within the coronary sinus during the perfusion process.
In a first aspect, the invention comprises a catheter having an inflatable member, preferably a balloon, mounted to the exterior surface of the catheter. The balloon is adapted for expansion or inflation between an inflated state and a retracted state. Means are provided between at least a portion of the interior surface of the balloon and the exterior surface of the catheter to prevent inadvertent sticking of the balloon body to the catheter as the balloon is inflated. The means for preventing the sticking include injecting a liquid lubricant between the balloon and the catheter body, positioning a spring between the balloon and catheter body, and positioning a fluid-permeable sleeve between the balloon and catheter body. Alternatively, the balloon can be stretched or elongated prior to adhering the balloon to the exterior surface of the catheter. Still another means for preventing sticking of the balloon to the catheter would be roughening the contact surfaces of one of the balloon and catheter body to thereby reduce the effective surface area of contact between these two elements. The roughening can be performed by chemical, mechanical, or electrical processes. The catheter incorporating means to prevent sticking of the balloon to the catheter body can be used in any application in which an expandable member such as a balloon is mounted to the exterior surface of the catheter body and in which it is desirable to prevent sticking of the balloon body to the catheter body during the inflation of the balloon. The preferred application of the invention is for use in a coronary surgical application.
In another aspect, the invention comprises a catheter which is ideally suited for use during the retrograde administration of cardioplegia solution. The catheter preferably comprises a catheter body and an inflatable member such as a balloon mounted to the exterior of the catheter body. The balloon is spaced from the proximal and distal ends of the catheter body a sufficient distance so that the balloon can be positioned immediately adjacent to and intermediate the inferior vena cava and the coronary sinus ostia during the retrograde administration of cardioplegia solution while the proximal and distal ends of the catheter body are positioned above the heart.
In the preferred embodiment, a stopcock is mounted to the proximal end of the catheter body, and a guide wire is selectively received in both the stopcock and the catheter body to provide support and rigidity for proper positioning of the catheter.
In still another aspect, the invention comprises a method for the retrograde administration of cardioplegia solution to the heart through the coronary sinus. A cardioplegia catheter is inserted into the coronary sinus through the coronary sinus ostia. A restriction catheter having a balloon provided thereon is positioned externally of the heart so that the balloon is immediately adjacent to the coronary sinus and at least one of the diaphragm and the inferior vena cava. The restriction catheter balloon is inflated so that the balloon bears against the coronary sinus ostia and one of the diaphragm and inferior vena cava. The inflated balloon restricts the coronary sinus ostia and prevents removal of the cardioplegia catheter during the retrograde administration of cardioplegia solution.
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Barra Jean-Aubert
Bocheff Carolyn Rose
Booth William Morris
Rodriguez Ernest J.
Sandmore Donald R.
Foley & Lardner
Kennedy Sharon
Lam Ann Y.
Medtronic Inc.
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