Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Including means for graft delivery
Reexamination Certificate
2001-12-17
2004-10-26
Willse, David H. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Including means for graft delivery
C623S001110, C623S001130, C623S001350, C604S096010, C606S108000
Reexamination Certificate
active
06808534
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to a system and method for emplacing a prosthesis and more particularly, to a reduced profile delivery system and method of use for placement of a bifurcated graft having attachment systems within a corporeal lumen.
It is well established that various fluid conducting bodies or corporeal lumens, such as veins and arteries, may deteriorate or suffer trauma so that repair is necessary. For example, various types of aneurysms or other deteriorative diseases may affect the ability of the lumen to conduct fluids and in turn may be life-threatening. In some cases, the damaged lumen is repairable only with the use of a prosthesis such as an artificial vessel or graft.
For repair of vital vessels, such as the aorta, surgical repair is significantly life-threatening. Surgical techniques known in the art involve major surgery in which a graft resembling the natural vessel is spliced into the diseased or obstructed section of the natural vessel. Known procedures include surgically bypassing the damaged or diseased portion of the vessel and inserting an artificial or donor graft attached to the native vessel by an anastomosis.
It is known within the art to provide a prosthesis for intraluminal repair of a vessel, such as an abdominal aorta having an aneurysm. The art has taught to provide a prosthesis positioned in a vessel and then to secure the prosthesis within the vessel with hooks or staples. Improvements since the earliest prosthesis and intraluminal delivery systems have attempted to increase the flexibility of the entire grafting system and reduce the complexity of the implantation procedure.
More recent art has taught the use of bifurcated grafts having attachment systems configured on each end of the graft prior to delivery. These attachment systems required the use of multiple balloon catheters to expand each of the attachment systems individually. Although these recent improvements simplify the procedure and reduce risks to the patient, more improvement is possible.
In recent years, several devices have been developed in an attempt to treat an aortic aneurysm through intraluminal repair. For example, a method and article for performing an aneurysm repair, wherein a prosthetic graft is utilized to replace the damaged segment of the blood vessel have previously been developed. A plurality of radially spaced anchoring pins are located adjacent each end of the graft and provide means for securing the graft to the wall of the vessel. An assembly is provided for moving the graft within the vessel and permanently anchoring the graft to the wall of the vessel.
Additionally, there has been previously described a bifurcated aortic graft constructed for intraluminal insertion having a plurality of struts having angled hooks with barbs at their superior ends. An assembly for inserting the graft and implanting the hooks into the vessel lumen is also disclosed.
Others have disclosed an intraluminal grafting system including a hollow graft having an attachment means located at one end of the graft. The system includes positioning means for moving the graft within the vessel, the positioning means having a capsule positioned at one end for covering the graft attachment means. The disclosed positioning means further includes an inflatable member for securing the attachment means within the lumen.
Moreover, there has been described an aortic graft and apparatus for repairing an aneurysm that includes a tube graft secured within the aorta and an attachment means at each end of the graft. Intraluminal delivery is accomplished using a catheter having a balloon for expanding and securing the attachment means. The graft and attachment means are preferably enclosed by a sheath which covers the entire graft and attachment means.
There have also previously been developed arrangements including an intraluminal grafting system including a tubular graft having attachment means positioned at both ends. The system includes a positioning means for transporting the graft through a vessel lumen and for deploying the graft within the lumen. The positioning means includes an inflatable member, a capsule and means for removing the graft from the capsule. The capsule is disclosed as a rigid cylindrical member covering the entire graft.
A sheath for use in introducing a catheter in the body of a patient has also been previously described. The sheath includes a flexible elongate tube and a backflow adapter having a hemostatic valve secured to the proximal extremity of the tube. The sheath may be used for introducing a deployment catheter into a femoral artery of the patient. The use of a sheath in such a manner has proven to be beneficial in the delivery and deployment of a graft prosthesis, however, several drawbacks must still be addressed. For example the leading edge of the sheath may cause trauma to the vessel during delivery. One attempt to remedy this problem was introduced in the form of a rigid guard member positioned upon the distal portions of the delivery system that may provide a covering and a smooth transitional surface about the leading edge of sheath thereby buffering the traumatic leading edge from causing damage to the vessel during the delivery of the graft prosthesis. However, this attempted solution has been shown to be of limited benefit as the rigid guard member may cause further complications during the deployment process such as snagging a partially deployed graft during the deployment procedure. Therefore, further improvements may be made to enhance the safety and ease of use of such a system.
To provide consistency with the common usage of terms used in the medical surgical arts in the United States, the terms “proximal, distal, inferior and superior” are used with a certain regularity within the present specification. “Proximal” refers to parts of the system, such as catheters, capsules and wires, which are closest to the user and closest to that portion of the system lying outside or exterior of the patient. “Distal” refers to the point farthest from the user and typically most interior of the corporeal lumen. The term “superior” refers to a location situated upstream of the flow of blood and is used herein in description of the graft and attachment system. “Inferior” refers to the point situated downstream of the flow of blood and again is used herein with reference to the graft and attachment system.
A typical procedure used with the described invention uses a “femoral approach.” This term describes an application which begins with an incision in the femoral artery. Similarly, the described invention may be used in an “iliac approach” which begins with an incision in the iliac artery. Using the terminology defined in the previous paragraph, the distal tip of the system maybe inserted into the femoral artery and advanced upstream into the iliac artery and the abdominal aorta. Thus, the more distal portions of the system reside upstream of those portions described as more proximal. Furthermore, in the described procedure, the superior portions of the graft will permanently reside in the abdominal aorta, while the inferior portions will reside in the iliac arteries.
The terms “ipsilateral” and “contralateral” typically refer to opposing portions of a corporeal lumen having symmetric right and left sides. “Ipsilateral” refers to those portions residing on the same side through which the grafting system enters the corporeal lumen, while “contralateral” refers to the opposite portions. Therefore, this distinction is dependent on whichever side (right or left) the physician decides to insert the grafting system. The portions of the grafting system which reside or operate within the symmetric vessels of the corporeal lumen use the same terminology. For example, the physician may insert the grafting device into the ipsilateral femoral artery, advance the device through the ipsilateral iliac artery and into the abdominal aorta. Then the device can be manipulated downstream into the contralateral iliac artery.
What has been needed and heretofor
Blanco Javier G.
Endovascular Technologies, Inc.
Fulwider Patton Lee & Utecht LLP
Willse David H.
LandOfFree
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