Apex closure device

• US 9,839,415 B2
• Filed: 03/11/2013
• Issued: 12/12/2017
• Est. Priority Date: 01/30/2009
• Status: Active Grant

• Current Assignee: St Jude Medical LLC (Abbott Laboratories)
• Original Assignee: St Jude Medical LLC (Abbott Laboratories)
• Inventors: Tegels, Zachary J.
• Primary Examiner(s): Nguyen, Tuan V
• Assistant Examiner(s): IGBOKO, CHIMA U
• Application Number:
  US13/794,105
• Publication Number:
  US 20130253577A1
• Time in Patent Office: 1,737 Days
• Field of Search: 606213, 606214, 606215, 606232
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/34 Trocars; Puncturing needles pointed biopsy instruments A61B10/0233; devices for piercing the ear-lobes A44C7/001; seals or hemostasis valves A61M39/06
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2017/3454 Details of tips

Abstract

Wound closure devices, systems, and methods may be used to close an opening, such as a puncture wound or incision, formed in tissue, such as heart tissue. A wound closure device may be configured and adapted to be placed within the puncture wound or incision to close and/or seal the puncture wound or incision. A bioadhesive may be used to strengthen the closure and/or seal of the puncture wound after placement of the wound closure device relative to the puncture wound.

Claims

1. A wound closure device for closing a wound opening accessing an interior of an organ, comprising:

a first section formed from a first material configured to promote tissue growth, the first section extending in a longitudinal direction between a trailing end and a distal end, and including a defined channel extending proximally from the distal end, the channel having an open end with a first transverse cross-section at the distal end of the first section, a closed end with a second transverse cross-section at a spaced distance from the trailing end of the first section, and a transverse cross-section between the open end and the closed end that is larger than the first transverse cross-section and the second transverse cross-section so as to define a recess in the channel; and

a second section positioned at the distal end of the first section, the second section having a protrusion positioned in the recess of the channel to secure the second section within the channel, the second section being formed from a second material different from the first material, wherein the first and second sections are sized for placement within the wound opening with the second section being proximate to the interior of the organ and separating the first section from the interior of the organ, the second section having a longitudinal axis and a distal end remote from the first section, the distal end of the second section being rounded in longitudinal cross-section.

2. The wound closure device according to claim 1, wherein the first material is a collagen-based material.

3. The wound closure device according to claim 1, wherein the first material is fibrous.

4. The wound closure device according to claim 1, wherein the first material is a gelatin.

5. The wound closure device according to claim 1, wherein the first material is resorbable.

6. The wound closure device according to claim 1, wherein the first material is non-thrombogenic.

7. The wound closure device according to claim 1, wherein the second material is a polymer.

8. The wound closure device according to claim 1, wherein the first section has a first diameter and the second section has a second diameter greater than the first diameter.

9. The wound closure device according to claim 1, wherein the second section has a compressed condition and an expanded condition and at least partially fills the recess in the channel upon movement from the compressed condition to the expanded condition.

10. A wound closure system for closing a wound through a wall of an organ to an interior of the organ, the wound closure system comprising:

a self-expandable stent frame configured and adapted to be placed within the wound in the wall of the organ, the stent frame having an expanded condition;

an anchor having a first end positionable in the interior of the organ and a second end receivable within the stent frame when the stent frame is in the expanded condition, the anchor being movable relative to the stent frame between an initial position in which the first end of the anchor is at a first position relative to the stent frame and a use position in which the first end of the anchor is at a second position relative to the stent frame, the second position being closer to the stent frame than the first position;

a wound closure plug movable relative to the stent frame between a starting position in which the wound closure plug is spaced apart from the stent frame and an assembled position in which the wound closure plug is received within the stent frame when the stent frame is in the expanded condition; and

a length of suture slidingly disposed through the wound closure plug and coupling the anchor to the wound closure plug.

11. The wound closure system according to claim 10, further comprising a retainer for holding the wound closure plug at a fixed distance from the anchor.

12. A method for closing a wound through a wall of an organ, the wall having an interior surface and an exterior surface, the wound accessing an interior of the organ, the method comprising:

providing a closure device having a first section and a second section, the first section being formed from a first material configured to promote tissue growth, the first section including a distal end, a trailing end and a channel extending proximally from the distal end toward the trailing end, and the second section being a body positioned at the distal end of the first section and within the channel, the second section including a leading end at a spaced distance from the first section and being formed from a second material different from the first material, the leading end of the second section being rounded in longitudinal cross-section;

placing a self-expanding stent into the wound in the wall of the organ;

expanding the stent within the wound;

fixing an anchor relative to one of the interior surface or the exterior surface of the wall of the organ;

inserting the leading end of the closure device into the stent;

advancing the closure device into the stent so that the closure device is substantially positioned within the wall of the organ with the leading end exposed to the interior of the organ and the trailing end exposed to an exterior of the wound;

sliding a length of suture through the closure device to couple the closure device to the anchor at a fixed distance from the anchor; and

applying a bioadhesive material over the trailing end of the closure device after the closure device has been advanced into the stent.

13. A wound closure device for closing a wound opening accessing an interior of an organ, comprising:

a first section formed a first material configured to promote tissue growth, the first section extending in a longitudinal direction between a trailing end and a distal end, and including a defined channel extending proximally from the distal end, the channel having an open end with a first transverse cross-section at the distal end of the first section, a closed end with a second transverse cross-section at a spaced distance from the trailing end of the first section, and a transverse cross-section between the open end and the closed end that is smaller than the first transverse cross-section and the second transverse cross-section so as to define a protrusion in the channel; and

a second section positioned at the distal end of the first section, the second section having a recess, the protrusion in the channel residing in the recess in the second section to secure the second section within the channel, the second section being formed from a second material different from the first material, wherein the first and second sections are sized for placement within the wound opening with the second section being proximate to the interior of the organ and separating the first section from the interior of the organ, the second section having a longitudinal axis and a distal end remote from the first section, the distal end of the second section being rounded in longitudinal cross-section.