Systems for sealing a tissue wall puncture

• US 10,357,232 B2
• Filed: 01/02/2017
• Issued: 07/23/2019
• Est. Priority Date: 01/28/2011
• Status: Active Grant

• Current Assignee: Apica Cardiovascular Limited (Thoratec LLC)
• Original Assignee: Apica Cardiovascular Limited (Thoratec LLC)
• Inventors: Jimenez, Jorge H., Greene, James L., Fitzgerald, Peter J.
• Primary Examiner(s): Scherbel, Todd J
• Application Number:
  US15/396,696
• Publication Number:
  US 20170143320A1
• Time in Patent Office: 932 Days
• 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 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/0498 for advancing a suture filament along a helical path through tissue
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/06076 helically or spirally coiled for sutures A61B2017/06171
• CPC Class Codes: A61B 2017/0649 Coils or spirals

Abstract

Embodiments of the invention provide systems, apparatus, device and methods for sealing a puncture in a tissue wall. According to one aspect, the system includes at least one supporting element for insertion into or placement on at least a portion of a tissue wall proximate a puncture to prevent expansion of the puncture; and a closing element adapted for at least partial insertion into the tissue wall and shaped to compress at least a portion of a tissue wall in an inward direction to close the tissue puncture when inserted at least partially into the tissue wall.

Claims

1. A system for closing a puncture formed in a tissue wall, the system comprising:

a supporting device comprising;

a first coil adapted for at least partial insertion into the tissue wall such that at least a portion of the first coil is disposed between a first surface and an opposite second surface of the tissue wall and proximate the puncture to inhibit expansion of the puncture; and

a first flange fixedly attached to the first coil and defining a central opening positioned along a central axis of the supporting device, the first flange adapted for positioning against the first surface of the tissue wall; and

a closing device comprising;

a second coil adapted for at least partial insertion through the central opening of the first flange and at least partial insertion into the tissue wall such that at least a portion of the second coil is disposed between the first surface and the second surface of the tissue wall and proximate the puncture to close the puncture; and

a second flange fixedly attached to the second coil, the second flange adapted for at least partial insertion through the central opening of the first flange and positioning against the first surface of the tissue wall,

wherein a minimum helical diameter of the first coil is greater than an the internal diameter of the central opening, wherein a maximum helical diameter of the second coil is less than the internal diameter of the central opening, and wherein a maximum outer diameter of the second flange is less than the internal diameter of the central opening.

2. The system of claim 1, wherein the first coil is adapted for compressing at least a portion of the tissue wall inward toward a central axis of the first coil when the first coil is inserted at least partially into the tissue wall.

3. The system of claim 1, wherein the first coil has a proximal end and a distal end, and wherein the first flange is fixedly attached to the proximal end of the first coil.

4. The system of claim 3, wherein a helical diameter of the first coil increases along at least a portion of the first coil in a direction from the proximal end toward the distal end of the first coil.

5. The system of claim 3, wherein a helical diameter of the first coil is constant along at least a portion of the first coil.

6. The system of claim 3, wherein the first coil has a first helical diameter at the proximal end of the first coil and a second helical diameter at the distal end of the first coil, wherein a maximum outer diameter of the first flange is greater than the first helical diameter, and wherein the maximum outer diameter of the first flange is less than the second helical diameter.

7. The system of claim 3, wherein the first coil comprises a sharpened tip positioned at the distal end of the first coil and adapted for piercing the first surface of the tissue wall.

8. The system of claim 3, wherein a central axis of the first coil is coaxial with the central axis of the supporting device.

9. The system of claim 1, wherein the second coil is adapted for compressing at least a portion of the tissue wall inward toward a central axis of the second coil when the second coil is inserted at least partially into the tissue wall.

10. The system of claim 1, wherein the second coil has a proximal end and a distal end, and wherein the second flange is fixedly attached to the proximal end of the second coil.

11. The system of claim 10, wherein a helical diameter of the second coil increases along at least a portion of the second coil in a direction from the proximal end toward the distal end of the second coil.

12. The system of claim 10, wherein a helical diameter of the second coil is constant along at least a portion of the second coil.

13. The system of claim 10, wherein the second coil has a first helical diameter at the proximal end of the second coil and a second helical diameter at the distal end of the second coil, wherein a maximum outer diameter of the second flange is greater than the first helical diameter, and wherein the maximum outer diameter of the second flange is less than the second helical diameter.

14. The system of claim 10, wherein the second coil comprises a sharpened tip positioned at the distal end of the second coil and adapted for piercing the first surface of the tissue wall.

15. A system for closing a puncture formed in a tissue wall, the system comprising:

a supporting device comprising;

a first coil adapted for at least partial insertion into the tissue wall such that at least a portion of the first coil is disposed between a first surface and an opposite second surface of the tissue wall, the first coil having a proximal end and a distal end; and

a first flange fixedly attached to the proximal end of the first coil and defining a central opening positioned along a central axis of the supporting device, the first flange adapted for positioning against the first surface of the tissue wall; and

a closing device comprising;

a second coil adapted for at least partial insertion through the central opening of the first flange and at least partial insertion into the tissue wall such that at least a portion of the second coil is disposed between the first surface and the second surface of the tissue wall and for compressing at least a portion of the tissue wall inward toward a central axis of the second coil when the second coil is inserted at least partially into the tissue wall, the second coil having a proximal end and a distal end; and

a second flange fixedly attached to the proximal end the second coil, the second flange adapted for at least partial insertion through the central opening of the first flange and positioning against the first surface of the tissue wall,

wherein a minimum helical diameter of the first coil is greater than an the internal diameter of the central opening, wherein a maximum helical diameter of the second coil is less than the internal diameter of the central opening, and wherein a maximum outer diameter of the second flange is less than the internal diameter of the central opening.