Stent introducer system
First Claim
Patent Images
1. A stent introducer systems comprising:
- a catheter comprising a flexible elongate catheter shaft having an inflatable balloon located adjacent the distal end thereof;
the inflatable balloon having a first, unexpanded exterior diameter and a second, expanded exterior diameter;
at least one flexible end cap having a mounting sleeve affixed to the catheter shaft at a region adjacent one end of the balloon and an annular socket surrounding a portion of the balloon, the annular socket having an interior diameter that is greater than the first, unexpanded exterior diameter of the balloon to create an annular zone between the socket and the unexpanded balloon; and
an expandable stent surrounding at least a portion of the balloon, wherein at least a portion of the stent is contained within the annular zone;
the apparatus being such that, upon expansion of the balloon, the stent is released from the annular zone.
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Accused Products
Abstract
A system for introducing a stent into a patient at a site of stenosis is disclosed. The system comprises a balloon catheter having a stent surrounding the balloon portion of the catheter. At least one stent-retaining means is located adjacent to at least one end of the balloon to retain the stent in position on the catheter until the balloon is inflated. Upon inflation of the balloon, the stent is expanded and the retention means releases the stent. The balloon is then deflated and the catheter is removed from the patient, leaving the expanded stent in place.
733 Citations
43 Claims
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1. A stent introducer systems comprising:
- a catheter comprising a flexible elongate catheter shaft having an inflatable balloon located adjacent the distal end thereof;
the inflatable balloon having a first, unexpanded exterior diameter and a second, expanded exterior diameter; at least one flexible end cap having a mounting sleeve affixed to the catheter shaft at a region adjacent one end of the balloon and an annular socket surrounding a portion of the balloon, the annular socket having an interior diameter that is greater than the first, unexpanded exterior diameter of the balloon to create an annular zone between the socket and the unexpanded balloon; and an expandable stent surrounding at least a portion of the balloon, wherein at least a portion of the stent is contained within the annular zone; the apparatus being such that, upon expansion of the balloon, the stent is released from the annular zone. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
- a catheter comprising a flexible elongate catheter shaft having an inflatable balloon located adjacent the distal end thereof;
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14. A stent introducer system comprising:
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a catheter comprising a flexible elongate catheter shaft having an inflatable balloon located adjacent the distal end thereof; and at least one flexible end cap having a mounting sleeve affixed to the catheter shaft at a region adjacent one end of the balloon and an annular socket surrounding said one end of the balloon to thereby define an annular space between the balloon and the socket. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22, 23)
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24. A method for introducing a stent into a patient, the method comprising the steps of:
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a) providing a stent introducer comprising; a catheter comprising a flexible, elongate catheter shaft having an inflatable balloon located adjacent the distal end thereof; the inflatable balloon having a first, unexpanded exterior diameter and a second, expanded exterior diameter; at least one flexible end cap having a mounting sleeve affixed to the catheter shaft at a region adjacent one end of the balloon and an annular socket surrounding a portion of the balloon, the annular socket having an interior diameter that is greater than the first, unexpanded exterior diameter of the balloon to create an annular zone between the socket and the unexpanded balloon; and an expandable stent surrounding at least a portion of the balloon, wherein at least a portion of the stent is contained within the annular zone; b) inserting the stent introducer into a blood vessel of the patient; c) guiding the introducer to a selected site; d) inflating the balloon to thereby expand and seat the stent at the selected site; e) deflating the balloon; and f) withdrawing the introducer from the patient.
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25. A method for introducing a stent into a patient, the method comprising the steps of:
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a) providing a stent introducer comprising; a catheter comprising a flexible, elongate catheter shaft having an inflatable balloon located adjacent the distal end thereof; the inflatable balloon having a first, unexpanded exterior diameter and a second, expanded exterior diameter; at least one flexible end cap having a mounting sleeve affixed to the catheter shaft at a region adjacent one end of the balloon and an annular socket surrounding a portion of the balloon, the annular socket having an interior diameter that is greater than the first, unexpanded exterior diameter of the balloon to create an annular zone between the socket and the unexpanded balloon; an expandable stent surrounding at least a portion of the balloon, wherein at least a portion of the stent is contained within the annular zone; and
,a sheath means surrounding the stent and a section of the catheter shaft located proximally thereto, said sheath means being slideable in the proximal direction to expose the stent prior to expansion thereof; b) inserting the stent introducer into a blood vessel of the patient; c) guiding the catheter to a selected site; d) sliding the sheath in the proximal direction to expose the stent; e) inflating the balloon to thereby expand and seat the stent at the selected site; f) deflating the balloon; and g) withdrawing the introducer from the patient.
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26. A stent introducer system comprising;
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a catheter comprising a flexible elongate catheter shaft having an inflatable balloon located adjacent the distal end thereof; and at least one flexible end cap mounted on the catheter shaft in the interior of the balloon at a region adjacent one end of the balloon. - View Dependent Claims (27, 28, 29, 30)
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31. A stent introducer system comprising:
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a catheter comprising a flexible elongate catheter shaft having an inflatable balloon located adjacent the distal end thereof; an expandable stent surrounding at least a portion of the balloon; and at least one flexible end cap mounted on the catheter shaft in the interior of the balloon at a region adjacent one end of the balloon, the end cap defining a shoulder on the exterior surface of the balloon when the balloon is deflated, to maintain the position of the stent on the exterior of the balloon. - View Dependent Claims (32, 33, 34)
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35. A method for introducing a stent into a patient, the method comprising:
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a) providing a stent introducer comprising; a catheter comprising a flexible elongate catheter shaft having an inflatable balloon located adjacent the distal end thereof; an expandable stent surrounding at least a portion of the balloon; and at least one flexible end cap mounted on the catheter shaft in the interior of the balloon at a region adjacent one end of the balloon; b) inserting the stent introducer into a blood vessel of the patient; c) guiding the introducer to a selected site; d) inflating the balloon to thereby expand and seat the stent at the selected site; e) deflating the balloon; and f) withdrawing the introducer from the patient.
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36. A stent introducer system for introducing a stent having a predetermined length into a lumen of a blood vessel comprising:
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a catheter having an elongated flexible shaft and an inflatable balloon mounted on the shaft adjacent the distal end of the shaft; a pair flexible end caps mounted on the catheter shaft, the end caps being disposed adjacent the ends of the balloon and each end cap having at least a portion positioned about a margin of the balloon, the end caps having shoulder-defining surfaces that face each other; the end caps being spaced so that their shoulder-defining surfaces are spaced from each other a distance no less than the predetermined length of the stent; whereby the stent may be mounted, in an unexpanded configuration, on the balloon, and between the facing surfaces of the end caps whereby the end caps will define an abutting surface engagable with the ends of the stent, thereby to retain the stent on the balloon.
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37. A stent introducer system comprising:
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a catheter comprising a flexible, elongate catheter shaft having an inflatable balloon located adjacent to the distal end thereof; and two flexible end caps, each end cap having a mounting sleeve affixed to the catheter shaft at a region adjacent one end of the balloon and an annular socket surrounding said one end of the balloon to thereby define an annular space between the balloon and the socket, wherein each end cap includes a weakening means in the region between the mounting sleeve and the annular socket. - View Dependent Claims (38, 39)
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40. A stent introducer system comprising:
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a catheter comprising a flexible, elongate catheter shaft having an inflatable balloon located adjacent to the distal end thereof; and a first flexible end cap mounted to the catheter shaft in the interior of the balloon at a region adjacent one end of the balloon and second flexible end cap having a mounting sleeve affixed to the catheter shaft at a region adjacent the other end of the balloon, the second end cap having an annular socket surrounding said other end of the balloon to thereby define an annular space between the balloon and the socket.
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41. A stent introducer system comprising:
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a catheter comprising a flexible elongate catheter shaft having an inflatable balloon located adjacent to the distal end thereof; and at least one flexible end cap mounted on the catheter shaft in the interior of the balloon in a region adjacent one end of the balloon wherein each of said at least one flexible end cap is wider at one end than at the other end and contains at least one slit extending along a portion of the end cap from the wider end toward the other end.
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42. A stent introducer system comprising:
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a catheter comprising a flexible, elongate catheter shaft having an inflatable balloon located adjacent the distal end thereof; an expandable stent surrounding at least a portion of the balloon; and at least one flexible end cap mounted on the catheter shaft in the interior of the balloon at a region adjacent one end of the balloon, the end cap defining a shoulder on the exterior surface of the balloon when the balloon is deflated, to maintain the position of the stent on the exterior of the balloon, and further wherein each of said at least one flexible end cap is wider at one end than at the other end and contains at least one slit extending along a portion of the end cap from the wider end toward the other end.
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43. A stent introducer system comprising:
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a catheter comprising a flexible, elongate catheter shaft having an inflatable balloon located adjacent the distal end thereof; an expandable stent surrounding at least a portion of the balloon; and at least one flexible end cap fabricated from a shape memory polymer and mounted on the catheter shaft in the interior of the balloon at a region adjacent one end of the balloon, the end cap defining a shoulder on the exterior surface of the balloon when the balloon is deflated to maintain the position of the stent on the exterior of the balloon.
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Specification