Stent introducer apparatus
First Claim
1. A stent delivery system for use in target duct or vessels having an acute bend at a known general location in the body of a patient, comprising:
- a pusher assembly that includes a pusher member configured to urge a preloaded stent from an introducer catheter into which it is slidably disposed, the pusher member being adapted to engage a proximal end of the stent, the pusher assembly comprising a first and a second tubular portion, at least a portion of the second tubular portion extending distal of the first tubular portion, the second tubular portion including a flexible section, the flexible section having a degree of flexibility that is greater than that of the first tubular section, and a stent-carrying section located distal to the flexible section, the pusher member being located along the second tubular section at point that is proximal to the stent-carrying section and is distal to the flexible section;
the flexible section of the second tubular portion having a preselected length and location along the pusher assembly such that when the pusher assembly and the preloaded stent are disposed within the introducer catheter and are subjected to lateral bending stresses at the known general location in the body, the flexible section of the second tubular portion traverses the known general location in the body, whereby the likelihood of a kink occurring in the introducer catheter is greatest within a region corresponding to the region of greatest flexibility of the pusher assembly.
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Accused Products
Abstract
Disclosed is a stent introducer apparatus comprising a introducer catheter, usually comprising clear polytetrafluoroethylene, and a pusher assembly that is configured to be able to deliver a stent, such as a self-expanding stent, within a tortuous duct or vessel, even if the introducer catheter becomes kinked during the procedure. In an embodiment for use in the biliary system, the pusher assembly includes a first tubular portion, comprising a material with high column strength, such as polyetheretherketone, and a shorter second tubular portion, which is made of a highly flexible material such as metal-braided polyimide or nititnol tubing, that is divided into a distal, stent-carrying section and a proximal, flexible section. The second tubular portion may be made of a smaller diameter that the first tubular portion to reduce possible impingement by the introducer catheter is the latter kinks during a procedure. At the junction between the stent-carrying and flexible sections is a pusher member to urge the stent from the distal end of the introducer catheter. In one aspect of the invention, the distal tip and pusher member tightly hold the stent to eliminate gaps so that the likelihood of the introducer catheter kinking at the contact point between the pusher member and stent is greatly reduced.
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Citations
40 Claims
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1. A stent delivery system for use in target duct or vessels having an acute bend at a known general location in the body of a patient, comprising:
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a pusher assembly that includes a pusher member configured to urge a preloaded stent from an introducer catheter into which it is slidably disposed, the pusher member being adapted to engage a proximal end of the stent, the pusher assembly comprising a first and a second tubular portion, at least a portion of the second tubular portion extending distal of the first tubular portion, the second tubular portion including a flexible section, the flexible section having a degree of flexibility that is greater than that of the first tubular section, and a stent-carrying section located distal to the flexible section, the pusher member being located along the second tubular section at point that is proximal to the stent-carrying section and is distal to the flexible section;
the flexible section of the second tubular portion having a preselected length and location along the pusher assembly such that when the pusher assembly and the preloaded stent are disposed within the introducer catheter and are subjected to lateral bending stresses at the known general location in the body, the flexible section of the second tubular portion traverses the known general location in the body, whereby the likelihood of a kink occurring in the introducer catheter is greatest within a region corresponding to the region of greatest flexibility of the pusher assembly. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A stent delivery system, comprising:
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an introducer catheter having a distal end and a distal portion;
a stent preloaded within the distal portion of the introducer catheter, the stent having a proximal end and a distal end;
a pusher assembly slidably disposed within the introducer catheter, the pusher assembly including both a second tubular portion having a first diameter and a first tubular portion having a second diameter, the first tubular portion being located proximate of the second tubular portion, the second diameter being greater than the first diameter;
a pusher member located along the second tubular portion, the pusher member including a distal face having a diameter equal to or greater than that of the stent preloaded in the introducer catheter, the distal face of the pusher member being disposed adjacent to the proximal end of the stent;
a distal tip affixed about the distal end of the second tubular portion, the stent being tightly held between the distal tip and the face of the pusher member such that during deflection of the stent introducer apparatus, the point along the introducer catheter that receives the largest amount of bending stress and represents the more likely point where a kink would occur, is located proximal the pusher member. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22, 23)
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24. A stent introducer apparatus to be slidably disposed within an introducer catheter, wherein the stent introducer apparatus comprises a pusher member for exerting a force on the proximal end of a stent in order to expel the stent from the distal end of the catheter after the stent has been positioned within the distal end of the at least one of the introducer catheter or the stent introducer apparatus, wherein the stent introducer apparatus further comprises a pusher assembly to be mounted within the introducer catheter and to be controllable from the proximal region of the stent introducer apparatus in order to exert the force on the pusher member;
- characterized in that a distal section of the apparatus and catheter has an increased ability to laterally flex in comparison to the remaining section of the stent introducer apparatus and introducer catheter, the distal section of the apparatus and catheter being at least partially proximal to the stent.
- View Dependent Claims (25, 26, 27, 28, 29, 30, 31, 32, 33, 34)
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35. A stent delivery system, comprising:
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an introducer catheter having a distal end and a distal portion;
a stent preloaded within the distal portion of the introducer catheter, the stent having a proximal end and a distal end;
a pusher assembly slidably disposed within the introducer catheter, the pusher assembly including both a second tubular portion comprising a metal braided reinforced polymer tube having a first outer diameter and including a distal end; and
a first tubular portion having a second outer diameter and located proximal the second tubular portion, the second outer diameter being greater than the first outer diameter;
the second tubular portion further comprising a stent-carrying section and a flexible section located proximal thereof, the stent-carrying section and flexible section divided by a pusher member that includes a face having a diameter equal to or greater than that of the stent preloaded in the introducer catheter; and
a distal tip affixed about the distal end of the second tubular portion, the stent being tightly held between the distal tip and the face of the pusher member such that during deflection of the stent introducer apparatus, the point along the introducer catheter that receives the largest amount of bending stress is located proximal the pusher member.
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36. A stent delivery system, comprising:
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an introducer catheter having a distal end and a distal portion;
a stent preloaded within the distal portion of the introducer catheter, the stent having a proximal end and a distal end;
a pusher assembly slidably disposed within the introducer catheter, the pusher assembly including both a second tubular portion having a first outer diameter and including a distal end; and
a first tubular portion having a second outer diameter and located proximal the second tubular portion, the second outer diameter being greater than the first outer diameter; and
a pusher member comprising a polymer material, the pusher member being located distal to the second tubular portion and in close proximity with the proximal end of the stent, wherein the likelihood of a kink between the stent and the pusher member, and between the distal and proximal ends of the stent, is reduced. - View Dependent Claims (37, 38, 39, 40)
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Specification