Sequential implant delivery system

• US 7,963,987 B2
• Filed: 12/28/2007
• Issued: 06/21/2011
• Est. Priority Date: 12/28/2007
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Magnuson, Mark A., Melsheimer, Jeffry S.
• Primary Examiner(s): Jackson; Gary
• Assistant Examiner(s): COLELLO, ERIN L
• Application Number:
  US11/966,369
• Publication Number:
  US 20090171427A1
• Time in Patent Office: 1,271 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.2, 623/1.16, 606/108
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

A method and device includes advancing a first stent and a second stent into a stenosed region of a blood vessel to protect or shield the vessel from possible blockage. The delivery device may include placement rings, selectively engagable by positioning members disposed on the outer wall of in inner catheter. The positioning members and the placement rings may be utilized to accurately place multiple stents within an afflicted vessel, in a single invasive procedure.

Claims

1. A method for using a sequential delivery device, comprising:

introducing a device into an organ, said device including an inner catheter, a first stent, at least a second stent, a floating placement ring, and an outer sheath;

said first stent having a proximal end, a distal end, an exterior surface, and an inner lumen;

said second stent having a proximal end, a distal end, an exterior surface, and an inner lumen;

said inner catheter having at least one member extending radially outward from an outer surface thereof to a first diameter, said member extending partially around a circumference of said inner catheter; and

said placement ring being disposed between said proximal end of said first self-expanding stent and a distal end of said member, wherein said placement ring comprises a first portion and a second portion, said first and second portions defining a receiving cavity, wherein said first portion has a second diameter that is greater than said first diameter of said member, and said second portion has a third diameter that is less than said first diameter of said member and greater than a diameter of said inner catheter,

disposing said device within a specified region of said organ, said distal end of said second stent being positioned approximately adjacent said proximal end of said first stent;

rotating said inner catheter to a first rotational position relative to said placement ring where said member is not aligned with said receiving cavity;

unsheathing said first stent within said organ by moving said sheath proximally with respect to said inner catheter and engaging said member in said first rotational position such that said distal end of said member engages said proximal end of said placement ring and a distal end of said placement ring engages said proximal end of said first stent, said member and said placement ring thereby providing a force against said proximal end of said first stent and preventing said first stent from moving proximally relative to said inner catheter during deployment;

advancing said second stent through said organ;

rotating said inner catheter to a second rotational position relative to said placement ring where said member is aligned with said at least one receiving cavity;

moving said placement ring along said inner catheter in said second position past said member; and

unsheathing said second stent.

2. The method of claim 1, wherein said first stent is a self expanding stent, and wherein said first stent expands when said outer sheath is withdrawn toward said proximal end of said blood vessel to expose said first stent.

3. The method of claim 1, wherein said second stent is a self expanding stent, and wherein said second stent is at least partially expanded upon withdrawal of said outer sheath.

4. The method of claim 1, wherein said second stent is a self expanding stent, said second stent being at least partially expanded upon withdraw of said outer sheath, and wherein said method further includes post-dilating said second stent with an inflation device.

5. The method of claim 1, wherein said member is integrally formed along said longitudinal axis of said inner catheter.

6. The method of claim 1, wherein said member comprises a flange protruding from an exterior surface of said inner catheter in a distal direction, at an angle less than 90 degrees.

7. The method of claim 5, wherein said member comprises one or more barbs, said barbs protruding from an exterior surface of said inner catheter in a distal direction, at an angle less than 90 degrees.

8. The method of claim 1, wherein said device further includes a fixed placement ring disposed at said proximal end of said second stent.

9. The method of claim 8, wherein said first stent is a self expanding stent, and wherein said first stent expands when said outer sheath is withdrawn toward said proximal end of said blood vessel to expose said first stent.

10. The method of claim 8, wherein said second stent is a self expanding stent, and wherein said second stent is at least partially expanded upon withdrawal of said outer sheath.

11. The method of claim 8, wherein said second stent is a self expanding stent, said second stent being at least partially expanded upon withdraw of said outer sheath, and wherein said method further includes post-dilating said second stent with an inflation device.

12. A sequential implant delivery device, comprising:

an inner catheter, a first stent, a second stent, at least a first and a second floating placement ring, and an outer sheath;

said inner catheter having at least one member extending radially outward from an outer surface thereof to a first diameter, said member extending partially around a circumference of said inner catheter;

said first stent having a proximal end, a distal end, an exterior surface, and an interior lumen; and

said second stent having a proximal end, a distal end, an exterior surface, and an interior lumen;

wherein said first and second placement rings are free from attachment to said inner catheter and said outer sheath, said first placement ring being disposed between said proximal end of said first stent and a distal end of said member;

wherein said first and second placement rings, said first stent, and said second stent are selectively movable along a longitudinal axis of said inner catheter,

wherein at least said first placement ring comprises a first portion and a second portion, said first and second portions defining a receiving cavity, wherein said first portion has a second diameter that is greater than said first diameter of said member, and said second portion has a third diameter that is less than said first diameter of said member and greater than a diameter of said inner catheter,

whereby when said first placement ring is in a first rotational position relative to said member, said member is not aligned with said receiving cavity, wherein as said inner catheter is moved distally with respect to said outer sheath, said member engages said proximal end of said first placement ring and a distal end of said first placement ring engages said proximal end of said first stent, said member and said first placement ring thereby providing a force against said proximal end of said first stent and preventing said first stent from moving proximally relative to said inner catheter during deployment, and

whereby when said first placement ring is in a second rotational position relative to said member, said member is aligned with said receiving cavity to allow said first placement ring to move proximally along said inner catheter past said member.

13. The device of claim 12, wherein said member comprises at least one flange.

14. The device of claim 13, wherein said device further includes a tertiary catheter affixed to a proximal placement ring.

15. The device of claim 12, wherein said outer sheath includes positioning members defined by a plurality of flanges, spaced along said longitudinal axis of an inner surface of said outer sheath.

16. The device of claim 12, wherein said outer sheath has a first inner diameter and a second inner diameter, creating an impingement surface for a proximal placement ring.