Closure devices, systems, and methods

• US 9,414,820 B2
• Filed: 01/08/2010
• Issued: 08/16/2016
• Est. Priority Date: 01/09/2009
• Status: Active Grant

• Current Assignee: Abbott Vascular Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Vascular Incorporated (Abbott Laboratories)
• Inventors: Voss, Laveille K., Fortson, Aaron M.
• Primary Examiner(s): Templeton, Christopher L
• Application Number:
  US12/684,470
• Publication Number:
  US 20100179572A1
• Time in Patent Office: 2,412 Days
• Field of Search: 606/144, 606/145, 606/139, 606/232, 606/142, 606/143, 604/164.04, 604/164.03, 604/107, 604/105, 604/106
• US Class Current: 1/1
• 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 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00867 shape memory effect

Abstract

A closure system is provided that may include a plurality of needle carriers each having detachable needles and at least one of the detachable needles detachably coupled to the needle carriers. The detachable needle may be configured to resist proximal movement when deployed in a vessel wall. The closure system may further include at least one suture secured to each of the detachable needles and a guide member having a plurality of first lumens in which each of the first lumens is sized to receive one of the needle carriers and one of the detachable needles coupled to the needle carrier. The first lumens may direct the needle carrier and the detachable needle radially outward and distally away from the guide member.

Claims

1. A closure system, comprising:

a plurality of needle carriers each having a distal end and a proximal end and a suture lumen;

a plurality of detachable needles, wherein prior to deployment thereof, at least one of the detachable needles is detachably coupled to the distal end of one of the needle carriers with a slip fit to allow the distal end of the one of the needle carriers and the at least one of the detachable needles to move together when moving in a distal direction and to allow the at least one of the detachable needles to detach from the distal end of the one of the needle carriers, the detachable needles having a base being configured to resist proximal movement when the detachable needles are deployed in a vessel wall;

at least one suture secured to each of the detachable needles, the at least one suture being located within one of the suture lumens;

a guide member having a plurality of first lumens defined internally therein extending distally from a proximal end of the guide member toward a distal end of the guide member, wherein each of the first lumens is sized to receive a respective one of the needle carriers and a respective one of the detachable needles coupled to the needle carrier, the first lumens having a curved, angled portion configured to direct the needle carrier and the detachable needle radially outward and distally away from the guide member;

an outer housing having a distal end and a proximal end, wherein a second lumen is defined between the distal end of the outer housing and the proximal end of the outer housing, the second lumen being configured to receive at least a portion of the guide member;

an expandable plug coupled to the distal end of the guide member, the expandable plug compressible to fit inside the second lumen of the outer housing and expandable when extended beyond the distal end of the outer housing, such that a distal end of the expandable plug is larger than the second lumen of the outer housing in an expanded configuration; and

an anchor member configured to be at least partially disposed within the second lumen, the anchor member comprising an anchor portion and an elongate portion, the anchor portion being disposed in the second lumen in an initial configuration and configured to move to an expanded configuration when positioned distally from the distal end of the outer housing and distal the distal end of the expandable plug, the anchor member being distal and the expandable plug when the anchor member is in the expanded configuration; and

wherein the first lumens of the guide member direct the needle carriers so that the detachable needles engage the vessel wall at a point adjacent to, in a direction transverse to a longitudinal axis of the guide member, an outer peripheral surface of each of the plug and the anchor member.

2. The closure system of claim 1, wherein the expandable plug is configured to be positioned between the guide member and the anchor member.

3. The closure system of claim 1, wherein the first lumens each further include an axial portion.

4. The closure system of claim 1, wherein at least one of the detachable needles includes a conical portion and a shaft, the conical portion having a tip, the base being wider than the shaft.

5. The closure system of claim 1, wherein the outer housing is coupled to a handle, the guide member is coupled to a first plunger, and the needle carriers are coupled to a second plunger.

6. The closure system of claim 5, wherein the guide member is configured to be moved between a retracted position in which the distal end of the guide member is positioned within the distal end of the outer housing and an extended position in which the distal end of the guide member is positioned distally of the distal end of the outer housing by moving the first plunger relative to the handle.

7. The closure system of claim 6, wherein the needle carriers are configured to be moved between a retracted position in which the detachable needles are positioned within the distal end of the guide member and an extended position in which the detachable needles are positioned distally of the distal end of the outer housing by moving the second plunger relative to the handle.

8. The closure system of claim 7, wherein the second plunger is operable independently from the first plunger.

9. The closure system of claim 1, wherein the anchor member further includes a plurality of control members coupled thereto, the control members extending proximally through the guide member.

10. A closure system, comprising:

first and second needle carriers, each having a distal end and a proximal end, the first needle carrier having a first suture lumen and the second needle carrier having a second suture lumen;

first and second detachable needles, wherein prior to deployment thereof, the first and second detachable needles are detachably coupled to the distal ends of the first and second needle carriers with a slip fit to allow the first and second needle carriers and the first and second detachable needles to move together when moving in a distal direction and to allow the first and second detachable needles to detach from the first and second needle carriers when the first and second needle carriers are drawn in a proximal direction, the first and second detachable needles having a base being configured to resist movement of the first and second detachable needles sufficiently to detach the first and second detachable needles from the first and second needle carriers, when the first and second needle carriers move in the proximal direction, after the first and second detachable needles are deployed in a vessel wall;

a first suture secured to the first detachable needle and a second suture secured to the second detachable needle, the first suture being located within the first suture lumen and the second suture being located within the second suture lumen;

a guide member having a plurality of first lumens formed in an interior of the guide member, each of the plurality of first lumens extending from a proximal end of the guide member toward a distal end thereof, wherein each of the first lumens is sized to receive a respective one of the needle carriers and a respective one of the detachable needles coupled to the needle carriers, the first lumens having an axial portion and a curved portion configured to direct the needle carrier and the detachable needle radially outward and distally away from the guide member;

an outer housing having a distal end and a proximal end, wherein a second lumen is defined between the distal end of the outer housing and the proximal end of the outer housing, the second lumen being configured to receive at least a portion of the guide member; and

an anchor member configured to be at least partially disposed within the second lumen, the anchor member comprising an anchor portion being disposed in the second lumen in an initial configuration and configured to move to an expanded configuration when positioned distally from the distal end of the outer housing; and

wherein the first lumens of the guide member direct the needle carriers so that the detachable needles engage the vessel wall at a point adjacent to, in a direction transverse to a longitudinal axis of the guide member, an outer peripheral surface of the anchor member in its expanded configuration.

11. The closure system of claim 10, further comprising an expandable plug configured to be positioned between the guide member and the anchor member.

12. The closure system of claim 11, wherein the expandable plug is coupled to the distal end of the guide member.

13. The closure system of claim 10, wherein at least one of the first and second detachable needles includes a conical portion and a shaft, the conical portion having a tip, the base being wider than the shaft.

14. A method of closing a puncture in a vessel, comprising:

advancing a distal end of a first member closure system into proximity with the puncture in a vessel wall, the closure system comprising;

first and second needle carriers, each having a distal end and a proximal end, the first needle carrier having a first suture lumen and the second needle carrier having a second suture lumen;

first and second detachable needles, wherein prior to deployment thereof, the first and second detachable needles are detachably coupled to the distal ends of the first and second needle carriers with a slip fit to allow the first and second needle carriers and the first and second detachable needles to move together when moving in a distal direction and to allow the first and second detachable needles to detach from the first and second needle carriers when the first and second needle carriers are drawn in a proximal direction, the first and second detachable needles having a base being configured to resist movement of the first and second detachable needles sufficiently to detach the first and second detachable needles from the first and second needle carriers, when the first and second needle carriers move in the proximal direction, after the first and second detachable needles are deployed in the vessel wall;

a first suture secured to the first detachable needle and a second suture secured to the second detachable needle, the first suture being located within the first suture lumen and the second suture being located within the second suture lumen;

a guide member having a plurality of first lumens formed in an interior of the guide member, each of the plurality of first lumens extending from a proximal end of the guide member toward a distal end thereof, wherein each of the first lumens is sized to receive a respective one of the needle carriers and a respective one of the detachable needles coupled to the needle carriers, the first lumens having an axial portion and a curved portion configured to direct the needle carrier and the detachable needle radially outward and distally away from the guide member;

an outer housing having a distal end and a proximal end, wherein a second lumen is defined between the distal end of the outer housing and the proximal end of the outer housing, the second lumen being configured to receive at least a portion of the guide member; and

an anchor member configured to be at least partially disposed within the second lumen, the anchor member comprising an anchor portion being disposed in the second lumen in an initial configuration and configured to move to an expanded configuration when positioned distally from the distal end of the outer housing; and

wherein the first lumens of the guide member direct the needle carriers so that the detachable needles engage the vessel wall at a point adjacent to, in a direction transverse to a longitudinal axis of the guide member, an outer peripheral surface of the anchor member in its expanded configuration;

advancing the anchor member through the second lumen and distally from the distal end of the outer housing and expanding the anchor member distally of the puncture in the vessel;

drawing the anchor member proximally into engagement with a posterior side of the vessel wall;

advancing the guide member through the second lumen and distally from the distal end of the outer housing to expose openings in the guide member, each of the openings being in communication with one of the plurality of first lumens defined in the guide member;

advancing the needle carriers and the needles coupled to the needle carriers through the plurality of first lumens to move the needles radially outward and distally away from the distal end of the guide member to pass the needles at least partially through the vessel wall;

retracting the needle carriers into the guide member to detach the needles from the needle carriers;

retracting the guide member into the second lumen; and

establishing tension in the sutures with a constrictor to move the needles toward each other to thereby close the puncture.

15. The method of claim 14, further comprising advancing an expandable plug through the second lumen and into contact with the vessel wall before the advancing the of needle carriers and the needles coupled to the needle carriers through the plurality of first lumens.

16. The method of claim 14, wherein the advancing of the needle carriers and the needles coupled to the needle carriers through the plurality of first lumens to move the needles radially outward and distally away from the distal end of the guide member includes using the two needle carriers and the two needles.

17. The method of claim 14, wherein the closure system further comprises third and fourth detachable needles, and third and fourth needle carriers;

wherein the advancing of the needle carriers and the needles coupled to the needle carriers through the plurality of first lumens to move the needles radially outward and distally away from the distal end of the guide member includes using the four needle carriers and the four needles.