Vascular hole closure delivery device

• US 9,226,738 B2
• Filed: 04/02/2012
• Issued: 01/05/2016
• Est. Priority Date: 02/15/2008
• Status: Active Grant

• Current Assignee: REX Medical LP
• Original Assignee: REX Medical LP
• Inventors: DeFonzo, Stephan A., Tarmin, James S., Anidharan, Thanu
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US13/437,146
• Publication Number:
  US 20120232583A1
• Time in Patent Office: 1,373 Days
• Field of Search: 606151-154, 606/157, 606/213, 606/215, 606/216, 606218-221
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0456 Surface features on the anchor, e.g. ribs increasing friction between the suture and the anchor
• CPC Class Codes: A61B 2017/0459 Multiple holes in the anchor through which the suture extends and locking the suture when tension is applied

Abstract

A surgical delivery instrument for delivering a vascular hole closure device having a hole covering member. The delivery instrument comprises a housing, a plunger and an advancer movable within the housing, the advancer having a first portion and a distal portion hingedly connected to the first portion and forming a casing for supporting the hole covering member. Distal movement of the advancer pivots the casing from an angled position to a more linear position to change the orientation of the covering member from a transverse position to a more aligned position. The plunger is advanceable to advance the covering member into the vessel.

Claims

1. A surgical delivery instrument for delivering a vascular hole closure device having a hole covering member, the delivery instrument comprising a housing, a plunger and an advancer movable within the housing, the advancer having a first portion and a distal portion hingedly connected to the first portion and forming a casing for supporting the hole covering member, wherein distal movement of the advancer pivots the casing from an angled position to a more linear position to change the orientation of the covering member from an angled position to a more aligned position, the plunger advanceable to advance the covering member into the vessel, the hole closure device includes first and second flexible members, the first flexible member having a first engagement member and the second flexible member having a second engagement member, wherein the plunger has first and second longitudinally extending openings and first and second engaging portions, the first engaging portion limiting movement of the first engagement member and the second engaging portion limiting movement of the second engagement member, wherein the first engagement member is held by the first engaging portion until a predetermined force is applied to the first engagement member during placement of the hole closure device at a target site and the second engagement member is held by the second engaging portion until a predetermined force is applied to the second engagement member during placement of the hole closure device at the target site.

2. The surgical delivery instrument of claim 1, wherein the first engaging portion comprises a first opening in a first grommet aligned with the first longitudinally extending opening and the second engaging portion comprises a second opening in a second grommet aligned with the second longitudinally extending opening.

3. The surgical delivery instrument of claim 1, wherein the housing includes an angled inner surface engagable by the casing to pivot the casing to the more linear position.

4. The surgical delivery instrument of claim 1, wherein the plunger includes a tube and a handle portion positioned proximally of the tube, and movement of the handle portion distally advances the tube within a lumen of the advancer.

5. The surgical delivery instrument of claim 1, further comprising a distal stop to limit distal movement of the advancer.

6. The surgical delivery instrument of claim 1, further comprising a first actuator for moving the advancer distally, the first actuator movable independently of the plunger.

7. The surgical delivery instrument of claim 1, wherein initial advancement of the plunger moves the advancer distally and subsequent advancement of the plunger advances the covering member into the vessel.

8. The surgical delivery instrument of claim 1, further comprising first and second rails operatively connecting the advancer and the plunger.

9. The surgical delivery instrument of claim 8, wherein the first and second rails are operatively dissociated from the plunger when the advancer is moved to a distal position into contact with the stop.

10. A surgical delivery instrument for delivering into a vessel a vascular hole closure device having a hole covering member, the delivery instrument comprising a housing, an advancer movable within the housing, and a plunger, the advancer movable to change the position of the covering member within the housing and the plunger subsequently movable to advance the covering member from the housing into the vessel, and first and second rails operatively connecting the advancer and the plunger.

11. The surgical delivery instrument of claim 10, wherein the hole closure device includes first and second flexible members, the first flexible member having a first engagement member and the second flexible member having a second engagement member, wherein the plunger has first and second longitudinally extending openings and first and second engaging portions, the first engaging portion limiting movement of the first engagement member and the second engaging portion limiting movement of the second engagement member, wherein the first engagement member is held by the first engaging portion until a predetermined force is applied to the first engagement member during placement of the hole closure device at a target site and the second engagement member is held by the second engaging portion until a predetermined force is applied to the second engagement member during placement of the hole closure device at the target site.

12. The surgical delivery instrument of claim 10, wherein movement of the plunger moves the advancer to change the position of the covering member.

13. The surgical delivery instrument of claim 10, further comprising a first actuator for moving the advancer, the first actuator movable independently of the plunger.

14. The surgical delivery instrument of claim 10, further comprising a stop to limit movement of the advancer, wherein the plunger is movable within the advancer when the advancer comes into contact with the stop.

15. A surgical delivery instrument for delivering a vascular hole closure device having a first flexible member having a first engagement member extending therefrom and a second flexible member having a second engagement member extending therefrom, the delivery instrument comprising a housing having first and second longitudinally extending lumens and first and second members, the first member having a first opening aligned with the first lumen, the second member having a second opening aligned with the second lumen, the first engagement member passing through the first opening when a predetermined proximal force is applied and the second engagement member passing through the second opening when a predetermined proximal force is applied, wherein the first engagement member is held by the first member until the predetermined proximal force is applied to the first engagement member during placement of the closure device at a target site.

16. The surgical delivery instrument of claim 15, wherein the second engagement member is held by the second member until the predetermined proximal force is applied to the second engagement member during placement of the closure device at the target site.

17. The surgical delivery instrument of claim 16, wherein the first flexible member is a suture and the second flexible member is a suture, and the delivery instrument further comprises a cutting member positioned within the housing for automatically severing the sutures.

18. The surgical delivery instrument of claim 15, wherein the first member has a third opening and the second member has a fourth opening, wherein the first engagement member is passable through the first opening when a first force is applied and subsequently passable through the third opening when a subsequent force is applied.

19. The surgical delivery instrument of claim 18, wherein the second engagement member is passable through the second opening when a second force is applied and subsequently passable through the fourth opening when a subsequent force is applied.

20. The surgical delivery instrument of claim 15, wherein the vascular hole closure device has a covering member at a distal end for positioning internal of a vessel and a first and a second retainer for positioning external of the vessel, the first flexible member extending between the covering member and the first retainer and the first engagement member positioned at a proximal portion of the first flexible member, and the second flexible member extending between the covering member and the second retainer and the second engagement member positioned at a proximal portion of the second flexible member, wherein proximal movement of the delivery instrument advances the first retainer and the second retainer toward the covering member.