Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-05-07
2001-07-17
Seidel, Richard K. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S523000
Reexamination Certificate
active
06261273
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to apparatus and methods for delivering a variety of medical devices, such as angioplasty balloons or stents to a precise position within a vessel through a delivery sheath or catheter. More particularly, the present invention provides a delivery sheath or catheter that may be used to position medical devices within two or more branches of a branched vessel.
BACKGROUND OF THE INVENTION
Numerous introducer sheaths and catheter systems have been developed for the endovascular delivery of a variety of medical devices, such as stents or angioplasty balloons. Typically, a guide wire is introduced into a vessel and advanced through the vasculature to a treatment site. A catheter is then advanced over the guide wire so that the distal end of the catheter is located at the treatment site. The catheter then may be used to transport and place any of a variety of medical devices or tools, such as stents, grafts, angioplasty balloons, atherectomy devices, etc., at the treatment site. The success of many minimally invasive medical procedures relies on the ability to precisely position such a catheter or sheath within a diseased vessel.
Endovascular procedures, such as angioplasty, may be complicated if the treatment site is near a bifurcation in a vessel. Complications may arise if, for example, one branch of the vessel will become closed or narrowed when an angioplasty balloon is inflated in the other branch.
It may also be necessary to treat both branches of a bifurcated vessel. For instance, when inserting a stent or graft in a bifurcated vessel to strengthen a diseased region of the vessel that spans both branches of the vessel, multiple stents may be required. Although such a procedure may be performed using previously known endovascular delivery apparatus and methods, the procedure may be difficult and time consuming, as it may be necessary to separately reinsert the catheter to place each of the stents.
Several prior catheter systems have attempted to address these difficulties. U.S. Pat. No. 5,720,735 to Dorros, for example, shows a catheter having a distal end with two branches. Two guide wires are used to deploy the branches of the distal end of the catheter into the two branches of a bifurcated vessel. A similar bifurcated catheter is shown in U.S. Pat. No. 5,613,980 to Chauhan.
A disadvantage of such previously known bifurcated access systems is that both branches of such systems are advanced through the vasculature simultaneously. Consequently, the delivery profile of such previously known devices may be quite large, herein the width of the distal end of the catheter is at least as wide as the combined diameters of the branching portions of the catheter. Consequently, access to narrow vessels is expected to be limited.
Additionally, if the region being treated with the previously known systems described in the aforementioned patents includes multiple branches, it may be necessary to repeatedly reinsert and reposition such catheter systems to treat all of the branches of the vasculature.
In view of the above, it would be desirable to provide apparatus and methods that permit rapid delivery and positioning of a medical device at a bifurcation in a vessel with an access device having a reduced delivery profile compared to previously known systems.
It would also be desirable to provide apparatus and methods that permit rapid delivery or positioning of a medical device within multiple branches of a vessel.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide apparatus and methods that permit rapid and accurate placement of a medical device in either or both branches of a bifurcated vessel.
It is another object of this invention to provide apparatus and methods that have a delivery profile only slightly larger than the width of the individual branches of the vessel.
It is a still further object of the present invention to provide apparatus and methods that permit rapid delivery and placement of a medical device within any one of multiple branches of a vessel having multiple branches.
These and other objects of the present invention are accomplished by providing a main tubular member having one or more openings disposed on a lateral surface near a distal end of the member. The main tubular member is positioned in a vessel so that the openings are aligned with branches of the vessel. A secondary tubular member, or one or more branch segments, are then extended through the openings and into the branches.
In one embodiment, the main tubular member is first positioned in one branch of a multi-branch vessel, and one or more branch segments are advanced down the main tubular member and extended through the openings into the branches of the vessel. Each branch segment has a flexible flange disposed at its proximal end and a diameter only slightly narrower than the diameter of the main tubular member. The flange permits the length of the branch segment to pass through one of the openings in the main tubular member, but prevents the proximal end of the branch segment from passing through the opening. By providing a branch segment for each of the branches of the vessel, a multi-branch sheath or catheter may be constructed in situ, and then used to deliver and position a variety of medical devices.
In an alternative embodiment, after the main tubular member is positioned in one branch of the vessel, a secondary tubular member is advanced through the main tubular member and extended through one of the openings into a branch of the vessel. The secondary tubular member may then be used to deliver or place medical devices within the branch of the vessel. After treatment of the branch is completed, the secondary member may be repositioned to extend through another opening to treat another branch, or repositioned to extend through the distal end of the main tubular member. The diameter of the secondary tubular member need be only slightly smaller than the diameter of the main tubular member. Alternatively, the secondary tubular member may include a lateral opening at a predetermined distance from its distal end that is aligned with the lumen of the main tubular branch, thereby providing access to both branches simultaneously.
REFERENCES:
patent: 4774949 (1988-10-01), Fogarty
patent: 4905667 (1990-03-01), Foerster et al.
patent: 4909258 (1990-03-01), Kuntz et al.
patent: 5443500 (1995-08-01), Sigwart
patent: 5613980 (1997-03-01), Chauhan
patent: 5643340 (1997-07-01), Nunokawa
patent: 5653743 (1997-08-01), Martin
patent: 5709713 (1998-01-01), Evans et al.
patent: 5720735 (1998-02-01), Dorros
patent: 5906640 (1999-05-01), Penn et al.
Fish & Neave
Hayes Michael J
Pisano Nicola A.
Seidel Richard K.
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