Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Stent combined with surgical delivery system
Reexamination Certificate
2000-05-16
2003-09-02
McDermott, Corrine (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Stent combined with surgical delivery system
C606S108000
Reexamination Certificate
active
06613075
ABSTRACT:
BACKGROUND AND SUMMARY OF THE INVENTION
1. Technical Background
The present invention relates generally to medical devices, and more particularly to a self-expanding stent delivery catheter system having a rapid exchange configuration.
2. Discussion
Catheter systems are used in a variety of therapeutic applications, including many vascular treatments. Various types of catheters are available, such as balloon catheters for procedures such as angioplasty. Angioplasty can be used to treat vascular disease, in which blood vessels are partially or totally blocked or narrowed by a lesion or stenosis.
In many instances of vascular disease, a local area of a blood vessel may become narrowed. This narrowing is called a lesion or stenosis, and may take the form of hard plaque, cholesterol, fats, or viscous thrombus. Such a stenosis may cause heart attack or stroke, which are significant health problems affecting millions of people each year. Typical disease patterns involve stenosis development, causing a blockage or partial blockage at the site.
For example, various procedures are well known for addressing stenoses and opening body vessels that have a constriction due to plaque buildup or thrombus, etc. With such procedures, an expansive force may be applied to the lumen of the stenosis. This outward pressing of a constriction or narrowing at the desired site in a body passage is intended to partially or completely re-open or dilate that body passageway or lumen, increasing its inner diameter or cross-sectional area. In the case of a blood vessel, this procedure is referred to as angioplasty. The objective of this procedure is to increase the inner diameter or cross-sectional area of the vessel passage or lumen through which blood flows, to encourage greater blood flow through the newly expanded vessel.
Often, it is deemed to be desirable to leave a device in place at the site of the expanded lumen of the stenosis, to provide support for the vessel wall at that location. Such a device may provide a scaffold type of structure about which, for example, endothelium development can occur to help repair the diseased, injured or damaged area. This scaffold device is referred to as a stent or endoprosthesis, and may have various designs, often having a resilient, flexible and cylindrical spring shape. In some cases, the stent which is a flexible cylinder or scaffold made of metal or polymers may be permanently implanted into the vessel. The stent tends to hold the lumen open longer, to reinforce the vessel wall and improve blood flow.
Stenting has come to be an accepted interventional medical procedure in many situations where vessels require support on a long-term basis. In operation, a catheter is used to transport the stent into and through a blood vessel, until the stent or the like is positioned at a desired location. Once at the desired location, the stent is deployed to provide internal support of the vessel or other treatment.
Some stents are deployed by an angioplasty balloon catheter, either during the angioplasty procedure or after a balloon has opened up the stenosis. These are called balloon-deployed or balloon-expandable stents. The balloon-expandable stents are forcibly expanded by a balloon or similar device through plastic deformation of the stent from a smaller to a larger diameter.
Another type of stent is of the self-expanding variety. Self-expanding stents tend to resiliently expand from an initial diameter, and must be held constantly in compression to remain at the initial diameter during delivery. Typically, a single cylindrical sheath or similar device over the stent is needed to hold the stent or other endoprosthesis at an initial diameter during passage through the body vessel. Once the treatment site is reached, the sheath or other device is withdrawn from around the stent, and the stent resiliently expands in place of its own accord.
This invention generally relates to stents which are of the self-expanding type. More particularly, the invention relates to self-expanding stents or other endoprostheses delivered in a compressed condition under radial compression, and which are deployed by removing a restraining member to permit the stent to resiliently expand and support a body vessel at that location. The stent may be made of a continuous strand shaped as a generally cylindrical member and having a plurality of coiling and/or undulating spring portions wound from the strand so as to impart the desired radial expansion force. The stent may also be formed of a metal or polymer tube, with cuts or slits removed to form a lattice.
As an example, the present invention will be described in relation to coronary, peripheral, and neurological vascular stenting treatments. The coronary procedure is often referred to as “coronary stenting.” However, it should be understood that the present invention relates to any rapid exchange stent delivery system having the features of the present invention, and is not limited to a particular stent design or a particular deployment location.
Some catheters have a relatively long and flexible tubular shaft defining one or more passages or lumens, and may deliver and deploy the stent near one end of the shaft. This end of the catheter where the stent is located is customarily referred to as the “distal” end, while the other end is called the “proximal” end. The proximal end of the shaft may lead to a hub coupling for connecting the shaft and the lumens to various equipment. Examples of stents and catheters are shown in U.S. Pat. No. 5,843,176, entitled “Self-Expanding Endoprosthesis,” issued to Weier on Dec. 1, 1998; and also U.S. Pat. No. 5,968,070, entitled “Covered Expanding Mesh Stent,” issued to Bley et al. on Oct. 19, 1999. In addition, U.S. Pat. No. 6,019,778 to Wilson et al., entitled “Delivery Apparatus For A Self-Expanding Stent” describes a self-expanding stent delivery system.
A common treatment method for using such a catheter is to advance the catheter into the body of a patient, by directing the catheter distal end percutaneously through an incision and along a body passage until the stent is located within the desired site. The term “desired site” refers to the location in the patient's body currently selected for treatment by a health care professional. After the stent is deployed within the desired site, it will tend to resiliently expand to press outward on the body passage.
It is of course desirable to retain the stent securely in the proper position. The stent delivery system should also preferably protect the stent from damage or deformation during delivery. It is further desirable that the stent delivery system should be flexible and able to push through and traverse as many different anatomical arrangements and stenosis configurations as possible. Moreover, the stent delivery system should preferably have a positive mechanism for holding and then releasing and deploying the stent at the desired site. The stent delivery system also desirably includes a mechanism for securing the stent in the form of a sheath, capable of completely covering the compressed stent during insertion.
Stent delivery systems are often designed for the smallest possible outer diameter or profile at the distal end. This small profile may be preferred for access into small vessels following angioplasty, or during a procedure called “direct stenting” where no angioplasty is performed.
In addition, the stent delivery system should provide for high visibility under fluoroscopy. Often the stent delivery system will be used in conjunction with an outer guiding catheter, which surrounds and guides the stent delivery system to the desired site. The visibility of the stent delivery system on a fluoroscope may be affected by the size of the lumen through which radiopaque contrast fluid is injected. This fluid is generally injected through the annular space between the guiding catheter and the stent delivery system. The visibility can therefore preferably be increased by further reducing the outer diameter of the stent delivery system.
Like many cat
Healy Stephen R.
Inderbitzen Mark N.
Barrett Thomas
Cordis Corporation
McDermott Corrine
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