Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Made of synthetic material
Reexamination Certificate
1999-07-26
2002-06-11
McDermott, Corrine (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Made of synthetic material
C623S001100
Reexamination Certificate
active
06402779
ABSTRACT:
BACKGROUND OF THE INVENTION
A. Field of Invention
This invention relates to the field of intraluminal devices and particularly to intraluminal grafts useful as an inner lining for blood vessels or other body conduits. More particularly, the present invention provides tubular structures which can be expanded in a transversal direction to conform to the diameter of a particular vessel in a patient's anatomy.
B. Description of the Prior Art
Conventional vascular grafts have been used routinely for the repair of the human vasculature. These devices are typically flexible tubes of woven or knitted polyethylene terephthalate (PET or Dacron ®), porous polytetrafluoroethylene (PTFE) or porous polyurethane (PU). Grafts of biological origin have also been used, typically comprising preserved human umbilical or bovine arteries. These conventional vascular grafts usually require invasive surgical procedures for insertion to expose at least the two ends of the segment of vessel to be repaired. Frequently, it is necessary to expose the entire length of the vessel segment. These types of procedures can cause major trauma to the patient with corresponding lengthy recovery periods, and may result in occasional mortality. In addition, grafts of various sizes are required to conform to the specific vasculature of a patient.
Other methods have evolved which use intraluminal vascular grafts, adjustable stents providing structural support, or a combination of both. These devices are preferably remotely introduced into a body cavity using a catheter type of delivery system. Alternatively, these devices may be directly implanted by invasive surgery. The intent of these methods is to maintain patency after an occluded vessel has been reopened using balloon angioplasty, laser angioplasty, atherectomy, roto-ablation, invasive surgery, or a combination of these treatments.
Intraluminal vascular grafts can also be used to repair and provide structural support to aneurysmal vessels, particularly aortic arteries, by inserting an intraluminal vascular graft within the aneurysmal vessel so that it can withstand the blood pressure forces responsible for creating the aneurysm. In this environment, intraluminal vascular grafts provide new blood contacting surfaces within the lumen of a diseased living vessel. Moreover, intraluminal grafts are not limited to blood vessels, but have other applications, such as the repair and reconstruction of urinary tracts, biliary ducts, respiratory tracts and the like.
In the prior art, an intraluminal graft is collapsed and inserted into a body conduit at a smaller diameter at a location remote from the intended repair site. A catheter type of delivery system is then used to move the intraluminal graft into the repair site and then expand its diameter to conform to the inner surface of the living vessel. Various attachments, including adjustable stents or barbs, may also be used to secure the intraluminal graft to the subject vessel at the desired location without the necessity of invasive surgery.
Various attempts have been made to provide intraluminal vascular grafts with or without stents. For example, an intraluminal vascular graft was suggested as early as 1912 in an article by Alexis Carrel (“Results of the permanent intubation of the thoracic aorta”, Surg., Gyn. and Ob. 1912;15:245-248).
Ersek (U.S. Pat. No. 3,657,744) describes a method of using one or more stents to secure a flexible fabric vascular graft intraluminally, the graft and stent having been introduced distally and delivered to the desired position with a separate delivery system. According to this patent, the graft is introduced to the patient at its final diameter, since the device is placed following surgical exposure and resection of the injury site. The stents are mechanically deployed by twisting an external apparatus.
Choudhury (U.S. Pat. No. 4,140,126) describes a similar method of repairing aortic aneurysms whereby a PET vascular graft is fitted at its ends with metal anchoring pins and pleated longitudinally to collapse the graft to a size small enough to allow for distal introduction. The barbed anchoring pins are deployed by advancing a wire to mechanically increase the diameter of the rings.
Rhodes (U.S. Pat. No. 5,122,154), describes endovascular bypass grafts for intraiuminal use which comprises a sleeve made of standard graft material and unidirectionally hinged stents. The graft is longitudinally pleated for introduction, and the stents are expanded in location by external means.
Lee (U.S. Pat. No. 5,123,917) describes an intraluminal vascular graft made of flexible, radially expandable material and balloon-expandable stents. The material and stents are both radially expanded in situ using, e.g., a balloon.
Gianturco (U.S. Pat. No. 5,507,771), describes a self-expanding stent assembly with an elastic covering for the prevention of restenosis. The entire device fully self-expands upon deployment.
Meyers (U.S. Pat. No. 5,700,285) describes a seamed, thin walled intraluminal PTFE graft with balloon expandable stents. A balloon is employed to expand the graft and stents in location.
Banas (U.S. Pat. No. 5,749,880) similarly describes a reinforced vascular graft with radially expandable PTFE coupled with balloon expandable stents. The graft and stents are stretched beyond their plastic limits by a balloon to deploy the device.
Fogarty (U.S. Pat. No. 5,824,037) describes modular tubular prostheses made of radially expandable cloth material and self-expanding stents. The graft material is expanded by balloon, and the stents provide radial support for the reoriented cloth fibers.
Martin (European Patent Application EP 0893108 A2,) describes a stent-graft with a ribbon affixing a portion of a stent to a PTFE graft.
All of these devices have a number of drawbacks that make them undesirable for clinical use. First, devices made of non-expandable materials and having predetermined deployed diameters cannot accommodate variations in patient physiology, and changes in diameter between the distal and proximal implantation site.
Second, devices with plastically deformable stents cannot withstand external compression without deformation of the stents, limiting the use of the devices in patient's extremities.
Third, fully self-expanding devices must be deployed through a sheath, which typically compels the user to deploy the devices linearly, i.e. from the proximal to the distal end.
SUMMARY OF THE INVENTION
Therefore, it would be advantageous to provide an intraluminal device having a diameter which can be adjusted in vivo. It is further desirable to provide a device that is self-expandable so that it can recover from external compression. It is still further desirable to provide a device which can be deployed in a non-linear fashion, i.e., first attaching the proximal end, then attaching the distal end, and, finally adjusting the diameter of the device between the two ends.
It is an objective of the present invention to provide an intraluminal device which has initially a small diameter so that it can be introduced easily into the vessel of a patient from a remote location and which can be easily expanded in place to any desired diameter thereby conforming to the diameter of the vessel being repaired or reinforced.
A further objective is to provide an intraluminal device such as a stent graft including a conformable ePTFE tube and a self-expandable support stent.
A further objective is to provide a novel process for making a conformable ePTFE tube usable as an intraluminal device which can be radially deformed easily up to a preset diameter without exceeding its plastic deformation limit.
Other objectives and advantages of the invention shall become apparent from the following description of the invention.
An intraluminal device constructed in accordance with this invention includes at least one self-expanding stent affixed to a tube formed of a porous, conformable ePTFE. The term ‘conformable ePTFE tube’ shall be used herein to define a tube made from ePTFE using a particular process described
Colone William M.
Creer William L.
Farl Kevin G.
Sinnott Joseph B.
Teeter Barbara L.
Barrett Thomas
Endomed Inc.
McDermott Corrine
Rogers David E.
Squire Sanders & Dempsey L.L.P.
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