Surgery – Instruments – Internal pressure applicator
Reexamination Certificate
2000-02-11
2001-05-29
Buiz, Michael (Department: 3731)
Surgery
Instruments
Internal pressure applicator
Reexamination Certificate
active
06238410
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a stent delivery catheter system, such as the kind used in percutaneous transluminal coronary angioplasty (PTCA) procedures. More particularly, it relates to a stent delivery catheter employ a rolling retractable sheath which may be retracted to release a self-expanding or balloon expandable stent.
BACKGROUND OF THE INVENTION
In typical PTCA procedures, a guiding catheter is percutaneously introduced into the cardiovascular system of a patient and advanced through the aorta until the distal end is in the ostium of the desired coronary artery. Using fluoroscopy, a guide wire is then advanced through the guiding catheter and across the site to be treated in the coronary artery. An over the wire (OTW) balloon catheter is advanced over the guide wire to the treatment site. The balloon is then expanded to reopen the artery. The OTW catheter may have a guide wire lumen which is as long as the catheter or it may be a rapid exchange catheter wherein the guide wire lumen is substantially shorter than the catheter. Alternatively, a fixed wire balloon catheter could be used. This device features a guide wire which is affixed to the catheter and cannot be removed.
To help prevent arterial closure, repair dissection, or prevent restenosis, a physician can implant an intravascular prosthesis, or a stent, for maintaining vascular patency inside the artery at the lesion. The stent may either be a self-expanding stent or a balloon expandable stent. For the latter type, the stent is often delivered on a balloon and the balloon is used to the expand the stent. The self-expanding stents may be made of shape memory materials such as nitinol or constructed of regular metals but of a design which exhibits self expansion characteristics.
In certain known stent delivery catheters, a stent and an optional balloon are positioned at the distal end of the catheter, around a core lumen. The stent and balloon are held down and covered by a sheath or sleeve. When the distal portion is in its desired location of the targeted vessel the sheath or sleeve is retracted to expose the stent. After the sheath is removed, the stent is free to self-expand or be expanded with a balloon.
A number of sheath designs are known in the art including those disclosed in U.S. Pat. No. 4,732,152 to Wallsten ('152), U.S. Pat. No. 4,848,343 to Wallsten ('343), U.S. Pat. No. 4,875,480 to Imbert, U.S. Pat. No. 5,662,703 to Yurek et al. ('703), U.S. Pat. No. 5,690,644 to Yurck ('644) and WO 94/15549, all of which disclose using a sleeve formed of a doubled-over section of membrane to compress and contain the stent.
Wallsten '152 and Wallsten '343 disclose the use of lubricants on the interior walls of the membrane. Moreover, fluid may be introduced into the chamber that is formed, in part, by the walls of the doubled-over membrane.
The Imbert device contains small holes in the sleeve to allow for the expulsion of gas therefrom upon the introduction of a fluid into the region between the inner and outer walls. The holes are not sized to allow for fluid flow therethrough.
Yurek '703 discloses a stent that is retained distal to the inner tube by a folded over sheath. The outer layer of the sheath, although not the inner layer, is disclosed as being porous. The Yurek '644 patent and WO 94/15549 disclose a catheter in which a stent is mounted on an inner tube and retained by a double walled hose having micropores in the outer wall of the hose. The micropores allow for the flow of fluid therethrough. The Yurek catheter is of the rapid-exchange design.
U.S. Pat. No. 5,445,646 to Euteneuer et al., incorporated herein in its entirety by reference, discloses a stent delivery apparatus comprising a single layer sheath retaining sleeve means for retaining the stent in its delivery configuration attached to a slipping sleeve means for releasing the stent to self-expand. The slipping sleeves may be activated hydraulically by delivering a fluid to the area in between the inner and outer layers of the slipping sleeve.
While the use of rolling membranes is known, it is desirable to provide a medical device delivery system with a rolling retractable sheath in which the frictional interactions between the inner and outer walls of the sheath are reduced without requiring hydraulic activation. A rolling membrane eliminates the problem of sliding friction that is common with sliding sheaths as the rolling membrane, literally, rolls off of the stent. This, in turn, results in a lesser likelihood of the stent being damaged as the sheath is removed from over it. It is also desirable to provide such a system with a sealed rolling retractable sheath to prevent any lubricants interior to the sheath from interacting with any bodily fluids. It is also desirable to provide such a system having a rolling retractable sheath whose inner and outer walls exhibits different physical properties such as hoop strength and creep resistance. The creep resistance of the outer wall is of particular value in preventing the stent from growing in profile and thereby deforming the catheter sheath. Finally, it is desirable to provide a medical device delivery system which is self-priming.
The present invention addresses these needs in its various embodiments as described below.
SUMMARY OF THE INVENTION
The present invention provides a medical device delivery system which comprises an inner tube having a medical device mounting region at the distal region for concentrically mounting a medical device thereon and a rolling retractable sheath for retaining a medical device on the inner tube and a retraction device.
The rolling retractable sheath, which includes a rolling double walled member, may be formed of a single member folded over on itself or of two different members joined together and folded over on itself. It is disposed concentrically about the inner tube. The inner wall of the double walled member is attached to the inner tube proximal to the medical device mounting region and the outer wall of the double walled member is attached to a retraction device. The inner wall has a greater tendency to rollingly move upon the application of a rolling force than the outer wall.
A sealed chamber may optionally be formed by the inner and outer walls of the sheath, at least a portion of the inner tube and the portion of the retraction device which is distal to the point of attachment of the outer wall to the retraction device. The sheath is retractable from a delivery position to a release position. In the delivery position, the sheath covers at least a portion of the medical device mounting region while in the release position, the sheath no longer covers the medical device mounting region.
The retraction device, which is operably connected to the rolling retractable sheath for retraction of the retractable sheath, moves the outer wall in a proximal direction relative to the inner wall so that the sheath no longer covers the medical device mounting region.
In another embodiment, the invention provides a self-priming medical device delivery system comprising an inner tube, a rolling retractable sheath for retaining a medical device on the inner tube and a retraction device operably connected to the rolling retractable sheath for retraction of the retractable sheath.
The inner tube has a medical device mounting region at the distal region for concentrically mounting a medical device thereon. The rolling retractable sheath, formed of a material porous enough to allow fluids through, is disposed concentrically about the inner tube and includes a rolling double walled member. The inner wall of the rolling retractable sheath is attached to the inner tube proximal to the medical device mounting region while the outer wall is attached to a retraction device. In the delivery position, the sheath covers at least a portion of the medical device mounting region while in the release position the sheath no longer covers the medical device mounting region.
The retraction device is operably connected to the roll
Monroe Lance A.
Smith Scott R.
Sogard Dave J.
Vrba Anthony C.
Buiz Michael
Sci-Med Life Systems, Inc.
Truong Kevin
Vidas Arrett & Steinkraus
LandOfFree
Pulling membrane stent delivery system does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Pulling membrane stent delivery system, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Pulling membrane stent delivery system will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2504930