Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Stent combined with surgical delivery system
Reexamination Certificate
1999-04-07
2001-11-20
Truong, Kevin (Department: 3731)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Stent combined with surgical delivery system
C606S108000
Reexamination Certificate
active
06319275
ABSTRACT:
FIELD OF THE INVENTION
The present invention is a surgical device assembly and method. More particularly, it is an endolumenal prosthesis assembly and method for implanting an endolumenal prosthesis within a body lumen. Still more particularly, the invention is an endolumenal prosthesis delivery assembly with an endolumenal prosthesis releasably coupled to a first delivery member that tracks over a second delivery member which has an anchor that secures the second delivery member within the body lumen distally of the desired location for delivering the prosthesis.
BACKGROUND
A wide range of medical treatments have been previously developed using “endolumenal prostheses,” which terms are herein intended to mean medical devices that are adapted to be implanted within a body lumen. Examples of lumens in which endolumenal prostheses may be implanted include, without limitation: blood vessels, including arteries and veins, and such as for example those located within the coronary, mesentery, peripheral, or cerebral vasculature; the gastrointestinal tract; biliary ducts; the urethra; and fallopian tubes.
Various different types of endolumenal prosthesis have also been developed, each providing a uniquely beneficial structure intended to mechanically couple to the specifically targeted lumenal wall. For example, various stents, grafts, and combination stent-graft prostheses have been previously disclosed for implantation within body lumens in order to provide artificial radial support to the lumenal wall tissue while maintaining lumenal patency through the supported region. One more frequently disclosed arterial “stenting” procedure involves implanting a stent in an artery in order to provide radial support to the vessel to thereby prevent abrupt closure subsequent to recanalization of stenosed regions of the artery, such as by balloon angioplasty or atherectomy (mechanical dilation of stenosed vessel by radial balloon expansion or by direct removal of stenotic plaque, respectively).
Conventional Stent Designs
Stents are designed to provide radial support to the vessel wall and also forms a prosthesis passageway or stent lumen extending centrally through the stent in order to provide a conduit for flow through the stented region. Moreover, a wide variety of stent designs have been previously disclosed that differ in the aspect of their structural design. In general, most of these various stent structures include a network of integrated support members having a geometry such that the networked design defines a longitudinal passageway. The structural integrity of the integrated support members provides radial rigidity against physiological collapsible forces at the vessel wall, whereas the longitudinal passageway through the prosthesis allows for flow through the stented region.
Various examples of previously disclosed stent structures include, without limitation: wire mesh; coiled wire; slotted tubes; and connected rings. More detailed examples of these types of stents are also variously disclosed in the following references: U.S. Pat. No. 4,580,568 issued to Gianturco; U.S. Pat. No. 4,655,771 issued to Wallsten; U.S. Pat. No. 4,733,665 issued to Palmaz; U.S. Pat. No. 4,739,762 issued to Palmaz; U.S. Pat. No. 4,776,337 issued to Palmaz; U.S. Pat. No. 4,830,003 issued to Wolff et al.; U.S. Pat. No. 5,571,172 issued to Chin; U.S. Pat. No. 4,913,141 to Hillstead; U.S. Pat. No. 4,969,458 issued to Wiktor; U.S. Pat. No. 5,019,090 issued to Pinchuk; and U.S. Pat. No. 5,292,331 issued to Boneau; U.S. Pat. No. 5,817,152 issued to Birdsall. The disclosures of these references are herein incorporated in their entirety by reference thereto.
Conventional Stent Delivery Assemblies & Methods
Various stent delivery assemblies and methods have also been disclosed which are adapted to deliver particular stents within desired locations of specific body lumens or lumens and to thereafter implant the stents at their respectively desired locations. In general, stents are adapted to be delivered to the desired location by engaging the stent in a radially collapsed condition to a coupler on a delivery member or catheter which is adapted to be delivered to the desired location via known access procedures, such as for example via known translumenal procedures. In a further more detailed example adapted for percutaneous translumenal catheterization procedures, the delivery member is a catheter which is adapted to track over a second delivery member, such as for example a guidewire, which is specifically adapted to subselect a percutaneous translumenal path to the desired location and provide a rail for the first delivery member to follow.
Once delivered and positioned at the desired location for implantation, the stent is then adjusted to a radially expanded condition which is adapted to radially engage the interior surface of the lumenal wall tissue, such as a vessel wall in an arterial stenting procedure. Further to this generally applicable stent delivery method just described, various stent designs have also been disclosed which differ in the aspect of their structure which allows the expansion from the radially collapsed condition to the radially expanded condition. Examples of different stent structures which are adapted according to these varied modes of delivery include, without limitation: “self-expanding” stents, which generally expand under their own force once delivered to the desired stenting site; and “balloon expandable” stents, which generally expand under mechanical strain from an inflating balloon at the stenting site.
Further to the “self-expanding” stent variation just described, one more detailed example of this type of stent is adjustable from the radially collapsed condition to the radially expanded condition by removing a radial constraining member once delivered to the stenting site. This type of self-expanding stent is adapted to recover from an elastically deformed state, when radially confined by the constraining member in the radially collapsed condition, to a resting or recovered state in the radially expanded condition, when radially unconstrained. Further detailed examples of known constraining members for use in delivery systems for such known self-expanding stents include, without limitation, radially confining sheaths, releasable tethers, and other securing devices which are releasably coupled to the stent wall when in the radially collapsed condition. Still further, another more specific example of a previously disclosed “self-expanding” stent is one which is formed from a shape-memory alloy and is adjustable from the radially collapsed condition to the radially expanded condition by heating the stent once delivered to the stenting site, thereby inducing a heat-memory recovery of the material in the stent wall to the radially expanded condition. One drawback of self-expanding stent assemblies is the difficulty of accurate positioning. Specifically, the stent tends to advance or “pop” forward when released. For example, a self-expanding stent assembly utilizing a radially confining sheath will typically include an inner member to hold the stent in position while the outer sheath is removed. However, it has been observed that when the sheath is withdrawn, the stent tends to advance in unpredictable fashion.
Further to the “balloon expandable” stent variation previously described, according to one more detailed example a stent is crimped or otherwise held in the radially collapsed condition over an exterior surface of a balloon on the distal end of a balloon catheter. The balloon catheter is adapted to track over a guidewire to the desired location for stent implantation. Inflating the balloon at the desired location adjusts the stent to the radially expanded condition which is adapted to engage the body lumen or lumen wall. Subsequent deflation of the balloon thereby leaves the stent implanted within the lumen. Further detailed examples of previously known “balloon expandable” stents and related delivery assemblies include, without limitation: assemblies which provide stents
Brooks Dennis L.
Lashinski Robert D.
Swanson Vance E.
Medtronic Ave Inc.
Truong Kevin
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