Delivery system with helical shaft

• US 7,578,838 B2
• Filed: 01/12/2005
• Issued: 08/25/2009
• Est. Priority Date: 01/12/2005
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Melsheimer, Jeffry S.
• Primary Examiner(s): Nguyen; Anhtuan T.
• Assistant Examiner(s): Severson; Ryan J
• Application Number:
  US11/034,913
• Publication Number:
  US 20060155357A1
• Time in Patent Office: 1,686 Days
• Field of Search: 623/1.11, 623/1.23, 623/1.2, 623/1.34, 623/1.16, 623/1.12, 606/108
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

A delivery system is provided for releasing a medical device within a body cavity. The delivery system may be used in an intravascular procedure to implant a self-expandable stent. A helical structure on the shaft of the delivery system engages the inner surface of the stent. As a result, the stent may be released by rotating the shaft relative to the stent which pushes the stent forward from the distal end of the shaft.

Claims

1. A medical system comprising:

an implantable medical device; and

a delivery system comprising;

a shaft comprising an outer circumference with a helical raised region and an interposed helical recessed region, said helical raised and recessed regions disposed along a distal portion of said shaft;

a sheath comprising an inner circumference with a longitudinal raised region and an interposed longitudinal recessed region, said longitudinal raised and recessed regions disposed along a distal portion of said sheath;

wherein said outer circumference of said shaft is adapted to be disposed within said inner circumference of said sheath, said helical raised region of said shaft having a smaller outer diameter than an inner diameter of said raised longitudinal region of said sheath, said shaft thereby being longitudinally moveable within said sheath without rotating either of said shaft or said sheath; and

wherein said implantable medical device is receivable between said shaft and said sheath, said helical raised and recessed regions of said shaft engaging an inner surface of said implantable medical device and said longitudinal raised and recessed regions of said sheath engaging an outer surface of said implantable medical device;

wherein relative rotational movement between said shaft and said sheath, without any relative axial movement between said shaft and said sheath, is capable of causing said implantable medical device to move longitudinally relative to said shaft over a distance at least an entire length of said implantable medical device with substantially no relative rotational movement between said implantable medical device and said sheath;

wherein said implantable medical device may be released from a distal end of said delivery system.

2. The medical system according to claim 1, further comprising a first handle connected to said sheath and a second handle connected to a rod extending through said first handle, said rod being connected to said shaft.

3. The medical system according to claim 1, further comprising a first raised portion on said inner surface of said implantable medical device and a second raised portion on said outer surface of said implantable medical device, said first raised portion being engaged by said helical raised and recessed regions of said shaft, and said second raised portion being engaged by said longitudinal raised and recessed regions of said sheath.

4. The medical system according to claim 3, wherein said implantable medical device comprises radiopaque markers, said first raised portion and said second raised portion being formed by said radiopaque markers.

5. The medical system according to claim 1, wherein said implantable medical device is a self-expandable stent comprising a ring of undulating struts, said sheath compressing said stent into a collapsed diameter for intravascular delivery.

6. The medical system according to claim 5, further comprising first raised portions on said inner surface of said stent and second raised portions on said outer surface of said stent, said first raised portions being engaged by said helical raised and recessed regions of said shaft, and said second raised portions being engaged by said longitudinal raised and recessed regions of said sheath, said stent comprising at least one of said first raised portions and said second raised portions at each end of said stent.

7. The medical system according to claim 6, wherein said stent comprises radiopaque markers, said first raised portions and said second raised portions being formed by said radiopaque markers.

8. The medical system according to claim 6, wherein said stent further comprises at least one of said first raised portions and said second raised portions at an intermediate position between said ends of said stent.

9. The medical system according to claim 8, wherein said stent comprises radiopaque markers, said first raised portions and said second raised portions being formed by said radiopaque markers.

10. The medical system according to claim 1, wherein said helical raised and recessed regions of said shaft and said longitudinal raised and recessed regions of said sheath extend a length of at least two of said implantable medical devices, at least two of said implantable medical devices thereby being receivable between said shaft and said sheath one after the other.

11. The medical system according to claim 10, wherein said at least two implantable medical devices are self-expandable stents, said sheath compressing said stents into collapsed diameters for intravascular delivery.

12. The medical system according to claim 1, wherein said helical recessed region of said shaft comprises at least one groove.

13. The medical system according to claim 1, wherein said shaft further comprises a lumen extending through said shaft adapted to receive a guidewire.

14. The medical system according to claim 1, wherein said implantable medical device is a self-expandable stent, said sheath compressing said stent into a collapsed diameter for intravascular delivery;

further comprising a first handle connected to said sheath and a second handle connected to a rod extending through said first handle, said rod being connected to said shaft; and

said shaft further comprising a lumen extending through said shaft adapted to receive a guidewire.

15. The medical system according to claim 14, further comprising first raised portions on said inner surface of said stent and second raised portions on said outer surface of said stent, said first raised portions being engaged by said helical raised and recessed regions of said shaft, and said second raised portions being engaged by said longitudinal raised and recessed regions of said sheath, said stent comprising at least one of said first raised portions and said second raised portions at each end of said stent and at an intermediate position between said ends of said stent;

wherein said stent comprises radiopaque markers said first raised portions and said second raised portions being formed by said radiopaque markers;

said helical raised and recessed regions of said shaft and said longitudinal raised and recessed regions of said sheath extend a length of at least two of said implantable medical devices, at least two of said implantable medical devices thereby being receivable between said shaft and said sheath one after the other; and

said helical recessed region of said shaft comprises at least one groove.

16. A medical system comprising:

an implantable medical device; and

a delivery system comprising;

a shaft comprising an outer circumference with a helical raised region and an interposed helical recessed region, said helical raised and recessed regions disposed along a distal portion of said shaft;

a sheath comprising an inner circumference disposed along a distal portion of said sheath; and

wherein said outer circumference of said shaft is adapted to be disposed within said inner circumference of said sheath, said implantable medical device thereby being receivable between said shaft and said sheath, said helical raised and recessed regions of said shaft engaging an inner surface of said implantable medical device, said implantable medical device comprising a portion on an outer surface of said implantable medical device engaging said sheath, said portion restricting relative rotational movement between said implantable medical device and said sheath, and wherein relative rotational movement between said shaft and said sheath, without any relative axial movement between said shaft and said sheath, is capable of causing said implantable medical device to move longitudinally relative to said shaft over a distance at least an entire length of said implantable medical device with substantially no relative rotational movement between said implantable medical device and said sheath;

wherein said implantable medical device may be released from a distal end of said delivery system.

17. The medical system according to claim 16, further comprising a first handle connected to said sheath and a second handle connected to a rod extending through said first handle, said rod being connected to said shaft.

18. The medical system according to claim 16, further comprising a raised portion on an inner surface of said implantable medical device, said raised portion being engaged by said helical raised and recessed regions of said shaft.

19. The medical system according to claim 18, wherein said implantable medical device comprises radiopaque markers, said raised portion and said portion on said outer surface of said implantable medical device being formed by said radiopaque markers.

20. The medical system according to claim 16, wherein said implantable medical device is a self-expandable stent comprising a ring of undulating struts, said sheath compressing said stent into a collapsed diameter for intravascular delivery.

21. The medical system according to claim 20, further comprising raised portions on said inner surface of said stent, said raised portions being engaged by said helical raised and recessed regions of said shaft, said stent comprising at least one of said raised portions and said portions on said outer surface of said stent at each end of said stent.

22. The medical system according to claim 21, wherein said stent comprises radiopaque markers, said raised portions and said portions on said outer surface of said stent being formed by said radiopaque markers.

23. The medical system according to claim 21, wherein said stent further comprises at least one of said raised portions and said portions on said outer surface of said stent at an intermediate position between said ends of said stent.

24. The medical system according to claim 23, wherein said stent comprises radiopaque markers, said raised portions and said portions on said outer surface of said stent being formed by said radiopaque markers.

25. The medical system according to claim 16, wherein said helical raised and recessed regions of said shaft extend a length of at least two of said implantable medical devices, at least two of said implantable medical devices thereby being receivable between said shaft and said sheath one after the other.

26. The medical system according to claim 25, wherein said at least two implantable medical devices are self-expandable stents, said sheath compressing said stents into collapsed diameters for intravascular delivery.

27. The medical system according to claim 16, wherein said helical recessed region of said shaft comprises at least one groove.

28. The medical system according to claim 16, wherein said shaft further comprises a lumen extending through said shaft adapted to receive a guidewire.

29. The medical system according to claim 16, wherein said implantable medical device is a self-expandable stent, said sheath compressing said stent into a collapsed diameter for intravascular delivery;

further comprising a first handle connected to said sheath and a second handle connected to a rod extending through said first handle, said rod being connected to said shaft; and

said shaft further comprising a lumen extending through said shaft adapted to receive a guidewire.

30. The medical system according to claim 29, further comprising raised portions on said inner surface of said stent, said raised portions being engaged by said helical raised and recessed regions of said shaft, said stent comprising at least one of said raised portions and said portions on said outer surface of said stent at each end of said stent and at an intermediate position between said ends of said stent;

wherein said stent comprises radiopaque markers said raised portions and said portions on said outer surface of said stent being formed by said radiopaque markers;

said helical raised and recessed regions of said shaft extend a length of at least two of said implantable medical devices, at least two of said medical devices thereby being receivable between said shaft and said sheath one after the other; and

said helical recessed region of said shaft comprises at least one groove.