Methods and device for inserting and withdrawing a two piece stent across a constricting anatomic structure

• US 6,576,008 B2
• Filed: 07/06/2001
• Issued: 06/10/2003
• Est. Priority Date: 02/19/1993
• Status: Expired due to Fees

• Current Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Rioux, Robert F., Paddock, Kimberly A., Lehman, John W., Devonec, Marian A.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): BLANCO, JAVIER G
• Application Number:
  US09/899,112
• Publication Number:
  US 20020128705A1
• Time in Patent Office: 704 Days
• Field of Search: 604/8, 623/1.11, 623/1.12, 623/1.16, 623/23-4-, 623/23.7
• US Class Current: 623/1.16
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2002/047 Urethrae
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

A stent device and methods for inserting and removing a stent to and from an anatomical tract of a living being. The stent includes a distal segment and a proximal segment joined by a flexible connection structure. The stent is inserted using components comprising a delivery assembly such that the stent proceeds through the anatomical tract and seats the flexible connection structure of the stent in a natural constricting structure of the anatomical tract. The flexible quality of the connection structure permits the natural constricting functions of the anatomical tract to occur. The natural closure of the anatomical constricting structure stops the flow of fluid, for example, from a target organ which indicates that the stent is properly placed within the anatomical tract.

Claims

1. A method of placing a prosthesis into an anatomical tract that passes through an anatomical constricting structure, the prosthesis comprising a first segment, a second segment and a connection structure that flexibly connects the first and second segments, the prosthesis mounted on an insertion assembly, the method comprising:

inserting the prosthesis and the insertion assembly into an opening in the anatomical tract;

advancing the prosthesis through the anatomical tract using the insertion assembly until at least the first segment is at least partially located on a far side of the anatomical constricting structure from the opening in the anatomical tract;

at least partially withdrawing at least a first portion of the insertion assembly from the anatomical tract relative to the prosthesis; and

manipulating at least one of (a) a second portion of the insertion assembly and (b) a portion of the prosthesis to extend the connection structure through the anatomical constricting structure, the first segment being located entirely on the far side of the anatomical constricting structure, and the second segment being located entirely on a near side of the anatomical constricting structure relative to the opening in the anatomical tract.

2. The method of claim 1, wherein advancing the prosthesis through the anatomical tract using the insertion assembly comprises locating at least one of the first and second segments relative to at least one of an organ and a cavity associated with the anatomical tract.

3. The method of claim 2, wherein locating at least one of the first and second segments relative to at least one of an organ and a cavity comprises locating the first segment relative to an opening in a bladder.

4. The method of claim 3, wherein:

the first segment comprises a first end connected to the connection structure and a second end opposite the first end, the second end having an opening; and

locating the first segment relative to the opening in the bladder comprises advancing the second end of the first segment through the opening in the bladder and into the bladder such that fluid held in the bladder can flow through the opening of the second end and into the first segment.

5. The method of claim 4, wherein:

the insertion assembly comprises;

a mandrel,

a pusher mountable on the mandrel, and

a removal structure attached to one of the first and second segments; and

at least partially withdrawing at least a portion of the insertion assembly from the anatomical tract comprises removing the mandrel and the pusher from the anatomical constricting structure.

6. The method of claim 5, wherein locating the first segment relative to the at least one of an organ and a cavity comprises locating the first segment entirely on the far side of the anatomical constricting structure.

7. The method of claim 6, wherein manipulating one of the second portion of the insertion assembly and a portion of the prosthesis comprises pulling on at least a portion of the removal structure until the connection structure extends through the anatomical constricting structure and the second segment is entirely on the near side.

8. The method of claim 2, wherein:

the first segment comprises a first end connected to the connection structure and a second end opposite the first end, the second end having an opening; and

locating the first segment relative to the organ and/or cavity comprises advancing the second end of the first segment through an opening in the organ and/or cavity and into the organ and/or cavity such that at least one of liquids and gases flow through the prosthesis signaling entry of the first segment into the organ and/or cavity.

9. The method of claim 2, wherein locating at least one of the first and second segments relative to at least one of the organ and the cavity comprises advancing the first segment entirely through the anatomical constricting structure and advancing the second segment at most partially through the anatomical constricting structure.

10. The method of claim 9, wherein:

the insertion assembly comprises;

a mandrel;

a pusher mountable on the mandrel;

a removal structure attached to one of the first and second segments; and

at least partially withdrawing at least a portion of the insertion assembly from the anatomical tract comprises removing the mandrel and the pusher from the anatomical constricting structure.

11. The method of claim 10, wherein manipulating one of the second portion of the insertion assembly and a portion of the prosthesis comprises pulling on at least a portion of the removal structure until the connection structure extends through the anatomical constricting structure and the second segment is on the near side.

12. The method of claim 9, wherein manipulating one of the second portion of the insertion assembly and a portion of the prosthesis comprises pulling one of the second portion of the insertion assembly and a portion of the prosthesis to withdraw the second segment to the near side such that the connection structure extends through the anatomical constricting structure.

13. The method of claim 12, wherein said pulling comprises pulling at least a portion of a removal structure, the pulled portion of the removal structure attached to at least the second segment.

14. The method of claim 13, wherein the pulled portion of the removal structure includes at least a removal thread attached to the second segment.

15. The method of claim 12, wherein:

the insertion assembly comprises;

a mandrel,

a pusher mountable on the mandrel, and

a removal structure attached to one of the first and second segments; and

at least partially withdrawing at least a portion of the insertion assembly from the anatomical tract comprises removing the mandrel and the pusher from the anatomical constricting structure.

16. The method of claim 15, wherein pulling the second portion of the insertion assembly comprises pulling at least a portion of the removal structure that is attached to the second segment.

17. The method of claim 12, wherein:

the insertion assembly comprises;

a stiff member that extends through the first and second segments and the connection structure and that contacts an end of the first segment that is opposite an end of the first segment connected to the connection structure,

an insertion structure that extends through the second segment and the connection structure and into the first segment,

at least one segment release structure, each segment release structure releasably connecting the insertion structure to one of the first and second segments, and

a removal structure attached to at least the second segment; and

pulling at least one of the second portion of the insertion assembly and the portion of the prosthesis comprises pulling the insertion structure.

18. The method of claim 17, wherein:

the at least one segment release structure comprises a first segment release structure that releasably connects the insertion structure to the first segment; and

withdrawing at least a portion of the insertion assembly comprises withdrawing the first segment release structure to release the first segment from the insertion structure before pulling the insertion structure.

19. The method of claim 17, wherein withdrawing at least a portion of the insertion assembly further comprises at least partially withdrawing the stiff member from the prosthesis before pulling the insertion structure.

20. The method of claim 17, further comprising, after pulling the insertion structure, withdrawing the stiff member from the anatomical tract.

21. The method of claim 20, further comprising, after removing the stiff member, withdrawing the insertion structure from the anatomical tract.

22. The method of claim 21, wherein:

when the first and second segments and the connection structure are mounted on the insertion structure, the at least one segment release structure releasably connects the insertion structure to the first and second segments such that the connection structure is in a collapsed state; and

pulling the insertion structure after withdrawing the segment release structure that connects the insertion structure to the first segment causes the connection structure to expand from the collapsed state and extend through the anatomical constricting structure.

23. The method of claim 17, wherein withdrawing at least a portion of the insertion assembly further comprises withdrawing one of the at least one segment release structure that connects the insertion structure to the first segment before pulling the insertion structure.

24. The method of claim 23, wherein the at least one segment release structure further releasably connects the insertion structure to the first and second segments such that the first and second segments approximately abut each other.

25. The method of claim 17, wherein the stiff member contacts the first segment at a closed end of the first segment opposite an end of the first segment connected to the connection structure.

26. The method of claim 25, wherein at least partially withdrawing at least a portion of the insertion assembly from the anatomical tract relative to the prosthesis further comprises at least partially withdrawing the stiff member from the prosthesis before partially withdrawing the insertion structure from the anatomical tract.

27. The method of claim 26, further comprising withdrawing the stiff member from the anatomical tract.

28. The method of claim 27, wherein the at least one segment release structure releasably further connects the insertion structure to the first and second segments such that the first and second segments approximately abut each other.

29. The method of claim 25, further comprising, after partially withdrawing the insertion structure from the anatomical tract:

removing the second segment release structure from the insertion assembly to release the second segment from the insertion structure; and

withdrawing the insertion structure from the anatomical tract.

30. The method of claim 29, wherein:

when the first and second segments and the connection structure are mounted on the insertion structure, the at least one segment release structure releasably connects the insertion structure to the first and second segments such that the connection structure is in a collapsed state; and

pulling the insertion structure after withdrawing the segment release structure that connects the insertion structure to the first segment causes the connection structure to expand from the collapsed state and extend through the anatomical constricting structure.

31. The method of claim 12, wherein:

the insertion assembly comprises;

a stiff member that extends through the first and second segments and the connection structure and that contacts the first segment,

an insertion structure that extends through the second segment and the connection structure and into the first segment,

a first segment release structure that releasably holds the first segment relative to the insertion structure, and

a second segment release structure that releasably holds the second segment relative to the insertion structure;

at least partially withdrawing at least a portion of the insertion assembly from the anatomical tract relative to the prosthesis comprises removing the first segment release structure from the insertion assembly to release the first segment from the insertion structure; and

pulling at least one of the second portion of the insertion assembly and the portion of the prosthesis comprises partially withdrawing the insertion structure from the anatomical tract.

32. The method of claim 2, wherein:

locating at least one of the first and second segments relative to at least one of the organ and the cavity comprises advancing the first segment at most partially through the anatomical constricting structure; and

manipulating one of the second portion of the insertion assembly and a portion of the prosthesis comprises advancing the second portion of the insertion assembly further into the anatomical tract to advance the first segment entirely to the far side of the anatomical constricting structure such that the connection structure extends through the anatomical constricting structure.

33. The method of claim 32, wherein:

the insertion assembly comprises;

a stiff member that extends through the first and second segments and the connection structure and that contacts the first segment,

a first portion of the insertion assembly that extends through the second segment and the connection structure and into the first segment,

a first segment release structure that releasably holds the first segment relative to the insertion assembly, and

a second segment release structure that releasably holds the second segment relative to the insertion assembly; and

at least partially withdrawing at least a first portion of the insertion assembly from the anatomical tract relative to the prosthesis comprises removing the first segment release structure from the insertion assembly to release the first segment from the insertion structure; and

advancing the second portion of the insertion assembly comprises advancing the stiff member to advance the first segment entirely to the far side of the anatomical constricting structure.

34. The method of claim 33, wherein:

when the first and second segments and the connection structure are mounted on the insertion structure, the at least one segment release structure releasably connects the insertion structure to the first and second segments such that the connection structure is in a collapsed state; and

advancing the insertion structure after withdrawing the segment release structure that connects the insertion structure to the first segment causes the connection structure to expand from the collapsed state and extend through the anatomical constricting structure.

35. The method of claim 33, wherein the at least one segment release structure further releasably connects the insertion assembly to the first and second segments such that the first and second segments approximately abut each other.

36. The method of claim 32, wherein advancing the second portion of the insertion assembly comprises advancing the second portion to place the first segment in a location on the far side of the anatomical constricting structure that is relative to at least one of an organ and a cavity associated with the anatomical tract.

37. The method of claim 36, wherein placing the first segment in a location relative to at least one of an organ and a cavity comprises placing the first segment relative to an opening in a bladder.

38. The method of claim 37, wherein:

the first segment comprises a first end connected to the connection structure and a second end opposite the first end, the second end having an opening; and

placing the first segment relative to the opening in the bladder comprises advancing the second end of the first segment through the opening and into the bladder such that fluid held in the bladder can flow into the first segment.

39. The method of claim 32, wherein:

the insertion assembly comprises;

a stiff member that extends through the first and second segments and the connection structure and that contacts the first segment,

an insertion structure that extends through the second segment and the connection structure and into the first segment,

a first segment release structure that releasably holds the first segment relative to the insertion structure, and

a second segment release structure that releasably holds the second segment relative to the insertion structure;

at least partially withdrawing at least a first portion of the insertion assembly from the anatomical tract relative to the prosthesis comprises removing the second segment release structure from the insertion assembly to release the second segment from the insertion structure;

advancing the second portion of the insertion assembly comprises advancing the insertion structure to advance the first segment entirely to the far side of the anatomical constricting structure.

40. The method of claim 39, wherein:

when the first and second segments and the connection structure are mounted on the insertion structure, the at least one segment release structure releasably connects the insertion structure to the first and second segments such that the connection structure is in a collapsed state; and

advancing the insertion structure after withdrawing the segment release structure that connects the insertion structure to the second segment causes the connection structure to expand from the collapsed state and extend through the anatomical constricting structure.

41. The method of claim 40, wherein the at least one segment release structure further releasably connects the insertion structure to the first and second segments such that the first and second segments approximately abut each other.

42. The method of claim 39, further comprising:

removing the first segment release structure from the insertion structure; and

removing the insertion structure from the anatomical tract.

43. The method of claim 39, wherein advancing the second portion of the insertion assembly comprises advancing the second portion to place the first segment in a location on the far side of the anatomical constricting structure that is relative to at least one of an organ and a cavity associated with the anatomical tract.

44. The method of claim 43, wherein placing the first segment in a location relative to at least one of an organ and a cavity comprises placing the first segment relative to an opening in a bladder.

45. The method of claim 44, wherein:

the first segment comprises a first end connected to the connection structure and a second end opposite the first end, the second end having an opening; and

placing the first segment relative to the opening in the bladder comprises advancing the second end of the first segment through the opening and into the bladder such that fluid held in the bladder can flow into the first segment.

46. The method of claim 1, wherein:

locating the first segment entirely on the far side of the anatomical constricting structure, and locating the second segment entirely on a near side of the anatomical constricting structure relative to the opening in the anatomical tract signals placement of the connecting structure within the anatomical constricting structure by voluntary control of the anatomical constricting structure.