Closure system and methods of use

• US 8,758,400 B2
• Filed: 11/08/2010
• Issued: 06/24/2014
• Est. Priority Date: 01/05/2000
• Status: Expired due to Fees

• Current Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories)
• Original Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories)
• Inventors: Ginn, Richard S., Aldrich, William N., Belef, William Martin, Roe, Steven N., Carley, Michael T., Jabba, Ronald J., Salmon, Stephen M., Pantages, Anthony J., Sagastegui, Francisco Javier
• Primary Examiner(s): TYSON, MELANIE RUANO
• Application Number:
  US12/941,809
• Publication Number:
  US 20110106148A1
• Time in Patent Office: 1,324 Days
• Field of Search: 606/213, 623/23.72
• US Class Current: 606/213
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 18/148 having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/00862 elastic or resilient
• CPC Class Codes: A61B 2017/00986 Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/081 Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 2018/00595 Cauterization
• CPC Class Codes: A61B 2018/0063 Sealing

Abstract

An apparatus for sealing a passage through tissue communicating with a body lumen is provided. The apparatus includes an elongate member having a proximal end a distal end and a lumen extending from the distal end toward the proximal end defining a longitudinal axis. A plug member is disposed on the distal end and extends distally from the elongate member in a pre-deployed and deployed configuration. The plug member includes a distal port therein in communication with the lumen and has a cross-sectional diameter at a plug proximal end and a plug distal end greater than a cross-sectional diameter of the distal end of the elongate member in the pre-deployed configuration. The apparatus also includes a member extendable distally from the distal port, the member including a proximal end and a distal end.

Claims

1. An apparatus for sealing a passage through tissue communicating with a body lumen, the apparatus comprising:

an elongate member having a proximal end, a distal end, and a lumen extending from said distal end to said proximal end and defining a longitudinal axis;

a plug member disposed on said distal end and extending distally from said elongate member in a pre-deployed configuration and in a deployed configuration, and said plug member comprising a distal port therein in communication with said lumen, said plug member having a cross-sectional diameter at a plug proximal end and at a plug distal end that is greater than a cross-sectional diameter of said distal end of said elongate member in said pre-deployed configuration;

a locator member extending distally from said distal port of said plug member, said locator member comprising a proximal end and a distal end, in an inactivated configuration said distal end of said locator member being movable into said distal port of said plug member, and in an activated configuration said distal end of said locator member being restricted from moving into said distal port of said plug member, said locator member being deflectable, said locator member comprises a helically wound wire extending between said proximal end and said distal end of said elongate deflectable element, and wherein said control element comprises a tether extending along an outer surface of at least a portion of said helically wound wire; and

a control element coupled to said distal end of said locator member, said control element being movable proximally for reconfiguring said locator member into the activated configuration by causing an intermediate portion of said elongate deflectable element to buckle substantially transversely with respect to said longitudinal axis.

2. The apparatus of claim 1, wherein said plug member comprises a passage therein extending between said distal port and said lumen.

3. The apparatus of claim 2, further comprising a sealing member disposed in said passage for substantially sealing said passage from fluid flow therethrough.

4. The apparatus of claim 1, wherein said plug member is releasable from said elongate member.

5. The apparatus of claim 1, wherein said elongate member comprises an actuator for releasing said plug member from said distal end of said elongate member.

6. The apparatus of claim 5, further comprising one or more connectors on at least one of said distal end of said elongate member and said plug member for releasably securing said plug member to said distal end of said elongate member.

7. The apparatus of claim 5, wherein said plug member comprises bioabsorbable material.

8. The apparatus of claim 1, wherein said plug member comprises a helical thread pattern on its outer surface.

9. The apparatus of claim 1, wherein said intermediate portion of said elongate deflectable element has a cross-section in said activated configuration that is larger than a cross-section of said distal port.

10. The apparatus of claim 1, wherein said locator member and said elongate member comprise cooperating feedback elements for identifying when said locator member is inserted a predetermined distance through said elongate member.

11. The apparatus of claim 1, wherein said elongate member and said locator member include cooperating detents for substantially securing said locator member axially with respect to said elongate member.

12. The apparatus of claim 1, wherein said locator member comprises a marker band to provide a visual indication of the location of said plug member, said elongate member comprising a window or opening for identifying when said locator member is inserted a predetermined distance through said elongate member.

13. An apparatus for sealing a passage through tissue communicating with a body lumen, comprising:

an elongate member having a proximal end, a distal end, and a lumen extending from said distal end to said proximal end and defining a longitudinal axis;

a plug member disposed on said distal end and extending distally from said elongate member in a pre-deployed configuration and in a deployed configuration, and said plug member comprising a distal port therein in communication with said lumen, said plug member having a cross-sectional diameter at a plug proximal end and at a plug distal end greater than a cross-sectional diameter of said distal end of said elongate member in said pre-deployed configuration;

a locator member at least partially located in said lumen of said elongate member, said locator member extending distally from said distal port of said plug member, said locator member comprising a proximal end and a distal end, said elongate member and said locator member include cooperating detents for substantially securing said locator member axially with respect to said elongate member, said locator member comprises a marker band to provide a visual indication of the location of said plug member, said elongate member comprising a window or opening for identifying when said locator member is inserted a predetermined distance through said elongate member; and

a control element coupled to the locator member, said control member being operable to reconfigure said locator member from an inactivated configuration to an activated configuration, in said activated configuration said distal end of said locator member being restricted from moving into said distal port of said plug member.

14. The apparatus of claim 13, further comprising a sealing member disposed in said passage for substantially sealing said passage from fluid flow therethrough.

15. The apparatus of claim 13, wherein said plug member is releasable from said elongate member.

16. The apparatus of claim 13, wherein said elongate member comprises an actuator for releasing said plug member from said distal end of said elongate member.

17. The apparatus of claim 16, further comprising one or more connectors on at least one of said distal end of said elongate member and said plug member for releasably securing said plug member to said distal end of said elongate member.

18. The apparatus of claim 16, wherein said plug member comprises bioabsorbable material.

19. The apparatus of claim 13, wherein said plug member comprises a helical thread pattern on its outer surface.

20. The apparatus of claim 13, wherein said control element being movable proximally for reconfiguring said locator member into activated configuration by causing an intermediate portion of said locator member to buckle substantially transversely with respect to said longitudinal axis.

21. The apparatus of claim 20, wherein said locator member comprises a helically wound wire extending between said proximal end and said distal end of said locator member, and wherein said control element comprises a tether extending along an outer surface of at least a portion of said helically wound wire.

22. The apparatus of claim 20, wherein said intermediate portion of said locator member has a cross-section in said activated configuration that is larger than a cross-section of said distal port.

23. The apparatus of claim 20, wherein said locator member and said elongate member comprise cooperating feedback elements for identifying when said locator member is inserted a predetermined distance through said elongate member.

24. The apparatus of claim 13, wherein said plug member comprises a helical thread pattern on its outer surface, said helical thread pattern having a substantially square cross-section.