Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Stent combined with surgical delivery system
Reexamination Certificate
2002-06-06
2004-01-13
McDermott, Corrine (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Stent combined with surgical delivery system
C623S902000, C623S903000, C623S909000, C606S108000, C606S194000
Reexamination Certificate
active
06676694
ABSTRACT:
BACKGROUND OF INVENTION
1. Field of the invention
This invention relates, generally, to the medical arts. More particularly, it relates to a method for endoluminal installation of a stent graft.
2. Description of the prior art
Stent grafts are used to hold arteries open so that blood may flow therethrough. They also have utility in treating aneurysms, in effect replacing an artery where the walls of the artery have ballooned outwardly and are in danger of rupturing. Stent grafts are formed of materials that are inert to the human body so that they may be left in place indefinitely. The materials from which stent grafts are made are highly flexible so that they may be compressed into a small space such as a lumen of a catheter. The materials are also highly resilient, i.e. , have excellent memory, so that when a stent graft is pushed out of the lumen of a catheter, it expands under its inherent bias to its operable size.
Tubular stent grafts are relatively easy to deploy in straight sections of arteries. However, there are areas of the body where deployment is problematic because a tubular stent graft cannot be used. A section of the abdominal artery, just slightly upstream of where it divides into the left and right iliac arteries, also known as the left and right common iliac arteries, is prone to the development of aneurysms and is a location where a tubular stent graft has no utility.
The stent graft that has been developed for this problematic area of the abdominal artery is often described as looking like a pair of pants having a waist part with one long leg and one short leg depending therefrom. When properly deployed, the waist part and the short leg thereof are positioned within the aneurysm of the abdominal artery, just downstream of the renal arteries. The long leg has a trailing end disposed within a first common iliac artery. If the short leg were also elongate and if its trailing end could easily be fitted into the second common iliac artery, then the positioning of a stent graft in an abdominal artery aneurysm would not be problematic.
Deploying a stent graft in an abdominal artery aneurysm so that blood can flow through the stent graft and avoid putting pressure on the ballooned arterial walls is difficult because the waist part of the stent graft must be positioned within the abdominal artery, and the left and right legs of the stent graft must fit into the left and right common iliac arteries, respectively.
There are two basic designs for endoluminal stents having utility in the repair of abdominal aortic aneurysms. Two. elongate legs are provided in the first design. A first leg is positioned in the first iliac artery and a second leg is pulled into the second iliac artery to form an inverted “Y” configuration. The present invention pertains to the second design where the stent includes a long leg and a short leg. An extension for the short leg is manufactured as a separate piece and is known as a contralateral limb because it is laterally opposed with respect to the first elongate leg of the stent graft. The physician inserts the contralateral limb into the short leg, thereby creating a conduit from the stent to the contralateral iliac artery and excluding blood flow from the aneuryismaneurysm.
Thus, in the second design, an extension for the short leg must be manufactured as a separate piece, and the physician must insert the extension for the short leg into the second iliac artery and try to secure it to the short leg.
The method most commonly employed to join a contralateral limb to the short leg of a stent graft is to introduce the contralateral limb through an incision in the patient's leggroin. More particularly, the contralateral limb is endoluminally introduced through a common femoral artery. The leading end of the contralateral limb is inserted into the trailing end of the short leg of the stent graft and the trailing end of the contralateral limb is left in the second common iliac artery to complete the installation.
There are several drawbacks to this approach, but the primary drawback is that it requires a physician to correctly aim the leading end of the contralateral limb at the trailing end of the stent graft short leg. This is a very difficult task under fluoroscopy or other imaging technique. What might look like a perfect connection may be a complete miss. For example, if the leading end of the contralateral limb goes directly underneath the trailing end of the short leg of the stent graft, it will appear to the physician performing the procedure that the alignment is perfect and that the job has been successfully completed. The results of such a misalignment are catastrophic.
What is needed, then, is an improved method for endoluminally introducing the leading end of a contralateral limb into the trailing end of the short leg of a stent graft.
However, in view of the prior art considered as a whole at the time the present invention was made, it was not obvious to those of ordinary skill in the pertinent art how such need could be fulfilled.
SUMMARY OF INVENTION
The long-standing but heretofore unfulfilled need for an improved method for installing a contralateral limb to a stent graft in the area of an abdominal artery aneurysm is now met by a new, useful, and nonobvious invention. The novel method includes the steps of inserting a first guide wire through an incision endoluminally into a first common femoral artery and pushing the first guide wire into the abdominal artery until a leading end of the first guide wire extends beyond a leading end of the stent graft. A first sheath is endoluminally introduced into an elongate leg of the stent graft, using the first guide wire to guide the first sheath into the elongate leg. The elongate leg has a trailing end received within the first iliac artery. The first guide wire is then removed from the sheath. A first catheter having a return bend formed near its distal end and having a first magnet means mounted to the distal end is introduced into a lumen of the first sheath. The first catheter is pushed into the first sheath until the return bend emerges from the lumen of said first sheath. The first catheter is then displaced in a distal-to-proximal direction, relative to the incision site, until the first magnet means emerges from the hollow interior of the stent graft and into the interior of the aneurysm. A second catheter having a second magnet means on a distal free end thereof is introduced into a second, opposite femoral artery and positioned near the first magnet means so that the first and second magnet means (having a polarity opposite to that of the first) are attracted to one another. The second catheter is then pulled into the hollow interior of the stent graft. A second guide wire is then introduced into the lumen of the second catheter until the distal free end of the second guide wire has extended completely through the second catheter and through the stent graft. The first and second catheters are then removed. A second sheath is introduced over the second guide wire until the distal free end of the second sheath has entered the hollow interior of the stent graft. A contralateral limb is then introduced through the second sheath until the distal free end of the contralateral limb has extended from the second sheath and entered into the hollow interior of the stent graft. The contralateral limb deploys under its inherent bias so that it expands in diameter. The second sheath is then withdrawn and blood flows into a first end of the. stent graft and out the bifurcated lower end thereof into the left and right iliac arteries.
The steps of the novel method may also be performed with a modified version of the first catheter. An opening is formed in the distal end of the first catheter in close proximity to the first magnet means secured to the distal end of the first catheter. The opening may also be formed in close proximity to the reverse bend formed in the first catheter. A guide wire extends through the first catheter from its proximal end and exits through the opening. Thi
Landrem Kamrin
McDermott Corrine
Smith Ronald E.
Smith & Hopen , P.A.
LandOfFree
Method for installing a stent graft does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Method for installing a stent graft, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Method for installing a stent graft will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3231273