Surgery – Instruments – Means for inserting or removing conduit within body
Reexamination Certificate
1998-04-21
2001-09-11
Philogene, Pedro (Department: 3732)
Surgery
Instruments
Means for inserting or removing conduit within body
C606S194000, C606S195000
Reexamination Certificate
active
06287314
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to the field of intravascular stent deploying catheters, and more particularly to a catheter balloon formed of compliant material with a uniform radial expansion that provides for improved stent deployment.
In percutaneous transluminal coronary angioplasty (PTCA) procedures a guiding catheter is advanced until the distal tip of the guiding catheter is seated in the ostium of a desired coronary artery. A guidewire, positioned within an inner lumen of an dilatation catheter, is first advanced out of the distal end of the guiding catheter into the patient's coronary artery until the distal end of the guidewire crosses a lesion to be dilated. Then the dilatation catheter, having an inflatable balloon on the distal portion thereof, is advanced into the patient's coronary anatomy over the previously introduced guidewire until the balloon of the dilatation catheter is properly positioned across the lesion. Once properly positioned, the dilatation balloon is inflated with liquid one or more times to a predetermined size at relatively high pressures (e.g. greater than 8 atmospheres) so that the stenosis is compressed against the arterial wall and the wall expanded to open up the passageway. Generally, the inflated diameter of the balloon is approximately the same diameter as the native diameter of the body lumen being dilated so as to complete the dilatation but not overexpand the artery wall. After the balloon is finally deflated, blood flow resumes through the dilated artery and the dilatation catheter can be removed therefrom.
In such angioplasty procedures, there may be restenosis of the artery, i.e. reformation of the arterial blockage, which necessitates either another angioplasty procedure, or some other method of repairing or strengthening the dilated area. To reduce the restenosis rate and to strengthen the dilated area, physicians frequently implant an intravascular prosthesis, generally called a stent, inside the artery at the site of the lesion. Stents may also be used to repair vessels having an intimal flap or dissection or to generally strengthen a weakened section of a vessel. Stents are usually delivered to a desired location within a coronary artery in a contracted condition on a balloon of a catheter which is similar in many respects to a balloon angioplasty catheter, and expanded to a larger diameter by expansion of the balloon. The balloon is deflated to remove the catheter and the stent left in place within the artery at the site of the dilated lesion. See for example, U.S. Pat. No. 5,507,768 (Lau et al.) and U.S. Pat. No. 5,458,615 (Klemm et al.), which are incorporated herein by reference. Thus, stents are used to open a stenosed vessel, and strengthen the dilated area by remaining inside the vessel.
In conventional stent deploying balloon catheters, the balloon is made of essentially non-compliant material, such as nylon or polyethyleneterephthalate (PET). Such non-compliant material exhibits little expansion in response to increasing levels of inflation pressure. Because the non-compliant material has a limited ability to expand, the uninflated balloon must be made sufficiently large that, when inflated, the balloon has sufficient working diameter to compress the stenosis and open the patient's passageway. However, a large profile non-compliant balloon can make the catheter difficult to advance through the patient's narrow vasculature because, in a uninflated condition, such balloons form flat or pancake shape wings which extend radially outward. Consequently, the wings of an uninflated balloon are typically folded into a low profile configuration for introduction and advancement through the vessel. The wings are again produced upon deflation of the balloon following stent deployment within the patient. These wings on the deflated balloon are undesirable because they result in an increased balloon profile which can complicate withdrawing the catheter after stent deployment.
Although stents have been used effectively for some time, the effectiveness of a stent can be diminished if it is not properly implanted within the vessel. For example, expansion of a balloon folded into a low profile configuration for introduction into the patient, can cause nonuniform expansion of a stent mounted on the balloon. The nonuniform expansion of conventional designs has resulted in the use of an elastic sleeve around the balloon and under the stent to distribute force from the expanding folded balloon to the stent uniformly, see for example U.S. Pat. No. 5,409,495 (Osborn), which is incorporated herein by reference. However, such sleeves may fail to completely prevent the nonuniform expansion of the stent, they increase the deflated profile upon insertion into the patient, and they complicate the assembly of the stent onto the balloon. Additionally, the final location of the implanted stent in the body lumen may be beyond the physician's control where longitudinal growth of the stent deploying balloon causes the stent's position on the balloon to shift during deployment. As the balloon's axial length grows during inflation, the stent may shift position along the length of the balloon, and the stent may be implanted upstream or downstream of the desired location in the body lumen. Thus, balloons which have a large amount of longitudinal growth during inflation provide inadequate control over the location of the implanted stent.
Therefore, what has been needed is a stent delivery system in which the stent is more uniformly expanded and implanted into the patient. The present invention satisfies these and other needs.
SUMMARY OF THE INVENTION
The invention is directed to a stent delivery system with a stent deploying balloon formed of compliant material that uniformly expands the stent to properly implant the stent within the patient's body lumen.
The stent delivery system of the invention generally comprises a catheter having an elongated shaft with an inflatable balloon on a distal portion of the catheter and a stent disposed about the working length of the balloon. The balloon is formed of material compliant at least within a working range of the balloon, and which therefore provides for substantially uniform radial expansion within the working range. The compliant balloon material therefore expands substantially elastically when pressurized at least within the pressure range disclosed herein for use in inflating the stent deploying balloon of the invention. The compliant balloon material will generally be an highly elastic material. The term “compliant” as used herein refers to thermosetting and thermoplastic polymers which exhibit substantial stretching upon the application of tensile force. Additionally, compliant balloons transmit a greater portion of applied pressure before rupturing than non-compliant balloons. Suitable compliant balloon materials include, but are not limited to, elastomeric materials, such as elastomeric varieties of latex, silicone, polyurethane, polyolefin elastomers, such as polyethylene, flexible polyvinyl chloride (PVC), ethylene vinyl acetate (EVA), ethylene methylacrylate (EMA), ethylene ethylacrylate (EEA), styrene butadiene styrene (SBS), and ethylene propylene diene rubber (EPDM). The presently preferred compliant material has an elongation at failure at room temperature of at least about 250% to at least about 500%, preferably about 300% to about 400%, and a Shore durometer of about 50A to about 75D, preferably about 60A to about 65D.
When the stent delivery balloon of the invention is pressurized, the balloon expands radially in a uniform manner to a working diameter. Because the balloon expands uniformly without unwrapping wings, it will uniformly expand a stent mounted on the balloon. The uninflated balloon does not require folding into a low profile configuration for insertion into the patient or the use of elastomeric sleeves used with conventional stent deploying balloons made from relatively non-compliant material. Similarly, the balloon of the in
Lee Jeong S.
Lim Florencia
Advanced Cardiovascular Systems Inc.
Heller Ehrman White & McAuliffe
Philogene Pedro
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