Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Stent structure
Reexamination Certificate
1998-12-02
2003-10-28
Willse, David H. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Stent structure
Reexamination Certificate
active
06638300
ABSTRACT:
TECHNICAL FIELD
The following invention relates to surgical stents of a generally cylindrical configuration which can be surgically implanted into a body lumen, such as an artery, and radially expanded. More specifically, this invention relates to radially expandable surgical stents which exhibit little or no axial contraction when radially expanded.
BACKGROUND OF THE INVENTION
Surgical stents have long been known which can be surgically implanted into a body lumen, such as an artery, to reinforce, support, repair or otherwise enhance the performance of the lumen. For instance, in cardiovascular surgery it is often desirable to place a stent in the coronary artery at a location where the artery is damaged or is susceptible to collapse. The stent, once in place, reinforces that portion of the artery allowing normal blood flow to occur through the artery. One form of stent which is particularly desirable for implantation in arteries and other body lumens is a cylindrical stent which can be radially expanded from a first smaller diameter to a second larger diameter. Such radially expandable stents can be inserted into the artery by being located on a catheter and fed internally through the arterial pathways of the patient until the unexpanded stent is located where desired. The catheter is fitted with a balloon or other expansion mechanism which exerts a radial pressure outward on the stent causing the stent to expand radially to a larger diameter. Such expandable stents exhibit sufficient rigidity after being expanded that they will remain expanded after the catheter has been removed.
Radially expandable stents come in a variety of different configurations to provide optimal performance to various different particular circumstances. For instance, the patents to Lau (U.S. Pat. Nos. 5,514,154, 5,421,955, and 5,242,399), Baracci (U.S. Pat. No. 5,531,741), Gaterud (U.S. Pat. No. 5,522,882), Gianturco (U.S. Pat. Nos. 5,507,771 and 5,314,444), Termin (U.S. Pat. No. 5,496,277), Lane (U.S. Pat. No. 5,494,029), Maeda (U.S. Pat. No. 5,507,767), Marin (U.S. Pat. No. 5,443,477), Khosravi (U.S. Pat. No. 5,441,515), Jessen (U.S. Pat. No. 5,425,739), Hickle (U.S. Pat. No. 5,139,480), Schatz (U.S. Pat. No. 5,195,984), Fordenbacher (U.S. Pat. No. 5,549,662) and Wiktor (U.S. Pat. No. 5,133,732), each include some form of radially expandable stent for implantation into a body lumen.
Each of these prior art stents suffer from a variety of drawbacks which make them less than ideal. For instance, many of these expandable stents are not particularly flexible and they have a central axis which remains substantially linear when the stents are not yet expanded. Such lack of flexibility makes the stent difficult to thread along arterial pathways for proper positioning within the body of the patient. Another problem which is exhibited by each of these prior art stents is that when they are expanded radially, an axial length of these stents is decreased. Even the patent to Lau (U.S. Pat. No. 5,514,154), although it teaches a stent design which attempts to limit axial contraction, still exhibits some axial contraction, especially at one end thereof.
When a surgeon is positioning a stent within an artery or other body lumen, it is critical that the stent be positioned precisely where the surgeon desires the stent to be placed. A common occurrence with prior art stents is that the stent will be precisely located where desired before radial expansion and then when the stent is expanded, its axial contraction will cause the stent to not be finally located precisely where desired. Such a mis-location problem is compounded by the fact that most stents can only be easily expanded and not easily contracted once expansion has occurred.
Additionally, it is often difficult, even with state of the art medical imaging equipment, to accurately determine the location of a stent during implantation thereof within a body lumen. This difficulty in determining exactly what the position is of the stent compounds the problem of accurately locating the stent where desired. Accordingly, a need exists for a radially expandable stent which exhibits little or no axial contraction when radially expanded and which can be easily located by medical imaging equipment during the stent positioning process.
SUMMARY OF THE INVENTION
This invention provides a radially expandable stent which exhibits little or no contraction along an entire axial length thereof when the stent is expanded radially. The stent includes a series of struts which act as circumferential elements circumscribing the cylindrical contour of the stent. Each strut is aligned within a separate plane perpendicular to a central axis of the cylindrical contour of the stent and parallel to other planes of adjacent struts. The stent can have various different numbers of struts joined together to form the stent. However, at least two end struts are provided including a first end strut and a second end strut which define ends of the cylindrical contour of the stent. Intermediate struts are also typically provided between the two end struts.
Each of these struts exhibits a wave-like contour as they circumscribe the cylindrical contour of the stent. Thus, each strut has a series of bends which have troughs and crests alternating along the length of each strut. Each trough defines a portion of the strut which is most distant from adjacent struts and each crest defines a portion of the strut closest to adjacent struts. An amplitude of each strut, defined by the distance between the bottom of each trough and the top of each crest, is modified when the stent is radially expanded so that the amplitude is generally decreased.
The end struts are attached to adjacent intermediate struts by tie bars which act as axial elements connecting the two adjacent struts together. Tie bars can also connect adjacent intermediate struts to each other. Each tie bar attaches to the struts adjacent thereto through a first junction on one extremity of the tie bar and a second junction on an opposite extremity of the tie bar. Both the first junction and the second junction are located within troughs of the struts. Thus, the tie bars span a gap between adjacent struts at a maximum width portion of the gap. Not all of the gaps are necessarily spanned by tie bar axial elements. Rather, separate intermediate circumferential elements can be attached to each other through links which connect to the intermediate elements at locations spaced away from the troughs thereof. Depending on the flexibility needs for the stent, different numbers of troughs can be provided with tie bars attaching adjacent struts to each other. If enhanced flexibility is desired, a greater number of troughs will be left empty with as few as one tie bar located between adjacent struts. The undulating contour of the struts can either be serpentine with the struts lacking flat surfaces but rather curving entirely along their length, or the struts can be formed from a series of linear sections including linear trough sections and linear crest sections joined together by linear inflection sections.
To enhance the visibility of the stent when viewed by various different medical imaging devices, the struts forming the first end and the second end of the stent can be formed from a radio-opaque material, such as gold, silver or platinum which will allow the first end and second end of the stent to be clearly visible through a medical imaging or after implantation of the stent within a body lumen of a patient.
OBJECTS OF THE INVENTION
Accordingly, a primary object of the present invention is to provide a radially expandable stent which does not contract axially when expanded radially.
Another object of the present invention is to provide a stent which exhibits sufficient flexibility to allow a central axis thereof to bend, especially when the stent is being threaded through arterial pathways within a patient.
Another object of the present invention is to provide a surgical stent which exhibits little or no axial contraction at ends thereof when expand
Cook Incorporated
Godlewski Richard J.
Stewart Alvin
Willse David H.
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