Surgery – Instruments – Means for inserting or removing conduit within body
Reexamination Certificate
1999-09-22
2001-02-06
Philogene, Pedro (Department: 3732)
Surgery
Instruments
Means for inserting or removing conduit within body
C606S151000, C606S191000, C623S001110
Reexamination Certificate
active
06183481
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to medical devices and procedures. More particularly, the present invention relates to a method and apparatus for percutaneous introduction of an endoluminal stent or stent graft that is particularly suited for percutaneous delivery of bifurcated stents or stent grafts into the vascular system of a patient.
Transluminal prostheses for implantation in blood vessels, biliary ducts, or other similar organs of the living body are, in general, well known in the medical art. For example, prosthetic vascular grafts formed of biocompatible materials (e.g., Dacron or expanded, porous polytetrafluoroethylene (PTFE) tubing) have been employed to replace or bypass occluded or damaged natural blood vessels. Examples of prosthetic vascular grafts are described in U.S. Pat. No. 4,955,899 (issued to Della Coma, et al. on Sep. 11, 1990); U.S. Pat. No. 5,152,782 (Kowligi, et. al., Oct. 6, 1992).
A form of transluminal prostheses, used to maintain, open, or dilate tubular structures or to support tubular structures, is commonly known as a stent, or when covered or lined with biocompatible material, as a stent-graft or endoluminal graft. In general, the use of stents, and stent-grafts for treatment or isolation of vascular aneurysms and vessel walls which have been thinned or thickened by disease (endoluminal repair or exclusion) are well known.
Many stents and stent grafts, are “self-expanding”, i.e., inserted into the vascular system in a compressed or contracted state, and permitted to expand upon removal of a restraint. Self-expanding stents typically employ a wire of suitable material, such as a stainless steel, configured (e.g. bent) to provide an outward radial force, and/or formed of shape memory wire such as nitinol (nickel-titanium) wire. When the shape memory wire is employed, the stent is typically of a tubular configuration of a slightly greater diameter than the diameter of the lumen, e.g., blood vessel, in which the stent is intended to be used. The stent may be annealed at an elevated temperature and then allowed to cool in air so that the shape memory wire “remembers” the initial configuration. The shape memory wire is suitably martensitic at room temperature, austenitic at typical body temperature. For example type “M” nitinol wire is martensitic at temperatures below about 13° C. and is austenitic at temperatures above about 25° C.; type “M” wire will be austenitic at body temperature of 37° C. Such nitinol wire is “super elastic” in its austenitic state; the radial outward force exerted by the stent on the wall of the lumen, (e.g., blood vessel) is therefore substantially constant irrespective of the diameter of the vessel and the expanded stent.
Various forms of stents and/or stent grafts are described in U.S. Pat. Nos. 5,873,906 (issued to Lau, et. al. on Feb. 23, 1999); 5,302,317 (Kleshinski, et. al., May 11, 1999); 5,662,713 (Andersen, et. al., Sep. 2, 1997); 5,575,816 (Rudnick, et. al, Nov. 19th, 1996); 5,0507,767 (Maeda, et. al, Apr. 16th, 1996); 5,415,664 (Pinchuk, May 16, 1995); 4,655,771 (Wallsten, Apr. 7, 1987); 4,800,882 (Gianturco, Mar. 13, 1987); 4,907,336 (Gianturco, Sep. 9, 1988); and 5,718,724 (Goicoechea, Feb. 17, 1998).
In general, stents and stent grafts are deployed either by a “cut-down” procedure, i.e., cutting directly into the lumen from an entry point proximate to the site where the prosthesis is to be deployed, or through a less invasive percutaneous intraluminal delivery, i.e., cutting through the skin to access a lumen e.g., vasculature, at a convenient (minimally traumatic) entry point, and routing the stent graft through the lumen to the site where the prosthesis is to be deployed.
Intraluminal deployment is typically effected using a delivery catheter with coaxial inner (plunger) and outer (sheath) tubes arranged for relative axial movement. The stent is compressed and disposed within the distal end of the outer catheter tube in front of the inner tube. The catheter is then maneuvered, typically routed though a lumen (e.g., vessel), until the end of the catheter (and thus the stent) is positioned in the vicinity of the intended treatment site. The inner tube is then held stationary when the outer tube of the delivery catheter is withdrawn. The inner tube prevents the stent from being withdrawn with the outer tube, so that, as the outer tube is withdrawn, the stent radially expands into a substantially conforming surface contact with the interior of the lumen e.g., blood vessel wall. An example of such a delivery system is described in aforementioned U.S. Pat. No. 4,655,771 (Wallsten, Apr. 7, 1987).
Other more specialized forms of delivery systems are also used. For example, U.S. Pat. No. 5,415,664 issued to Pinchuk on May 16, 1995, describes a stent delivery and deployment apparatus including three concentric tubes: an interior hollow tube and an outer sheath (generally corresponding to the inner and outer tubes of the delivery system described above); and an inner tubular actuation member with a cup-like gripping member rigidly attached to the distal end thereof. Relative movement between the interior tube and the actuation member provides a selectively actuable clamping or gripping mechanism between the cup-like member and the end of the interior tube. The end of a stent or stent-graft is inserted into the cup-like member and clasped between the cup-like member and the end of the interior tube. The distal end of the introducer is inserted into the sheath and pulls the distal end of the stent into the sheath, thereby stretching and radially compressing the stent to a reduced diameter. The sheath containing the stent and the remainder of the introducer is maneuvered to the site for deployment of the stent. The introducer is held in a stationary position and the sheath is pulled partially back towards the proximal end of the introducer so that a middle portion of the stent is released from the sheath. The introducer, stent, and sheath can then be moved to precisely locate the stent before it is deployed. When the stent is in a precise desired location, the introducer is held in a stationary position and the sheath is pulled back further to release the proximal end of the stent. The distal end of the stent is then released from the cup-like cap member and the distal end of the hollow tube. The introducer is then removed through the lumen of the expanded stent.
Other devices for deploying self-expanding endoprosthesis are described in: U.S. Pat. No. 5,484,444 issued to Braunschweiler, et. al., on Jan. 16, 1996, (including a mechanism for recompressing and recapturing the endoprosthesis within an outer sheath to facilitate repositioning and extraction) and U.S. Pat. No. 5,833,694 (Poncet, Nov. 10, 1998) (including a mechanism for deploying multiple stents at multiple sites within a body passage without completely withdrawing any part of the deployment device from the patient's body); and 5,776,142 (Gunderson, Jul. 7, 1998) (including a mechanism for controlling axial movement of the ends of the stent towards each other while simultaneously controllably rotating the ends of the stent about the longitudinal axis to provide for its controlled radial expansion); and U.S. Pat. No. 5,700,269 (Pinchuk, et. al., Dec. 23, 1997) (including mechanism for retracting the stent).
The use of trigger or release wires to control expansion of self-expanding endoprosthesis are also known. For example, such a system is described in U.S. Pat. No. 5,019,085 issued to Hillstead on May 28, 1991. A stent is disposed on the exterior of the distal end of a catheter. An elongated wire is inserted down the catheter's passageway then routed outside the catheter through an opening in the catheter sidewall. The wire is then looped over the stent, and routed back into the catheter interior through a second opening in the catheter sidewall. The wire is routed through the catheter interior passageway to a third opening in the catheter sidewall where it is again routed outside the catheter's passageway to loop ov
Colone William M.
Creer William L.
Farl Kevin G.
Lee Peter Y.
Teeter Barbara L.
Endomed Inc.
Lechter Michael A.
Philogene Pedro
Rogers David E.
Squire Sanders & Dempsey
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