Vascular closure device

• US 9,782,156 B2
• Filed: 10/12/2016
• Issued: 10/10/2017
• Est. Priority Date: 09/28/2015
• Status: Active Grant

• Current Assignee: Arterica, Inc.
• Original Assignee: M-V Arterica AB
• Inventors: Larzon, Thomas, Whirley, Robert G., Karlsson, Daniel, Nyman, Henrik, Humphrey, Joseph, Larzon, Cecilia
• Primary Examiner(s): David, Shaun L
• Application Number:
  US15/291,991
• Publication Number:
  US 20170086807A1
• Time in Patent Office: 363 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 17/0401 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00676 promotion of self-sealing of the puncture
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

The present disclosure relates to a vascular closure device adapted for use in closing a puncture in a blood vessel after e.g. a percutaneous interventional procedure. The disclosure also relates to a method for vascular closure using such a vascular closure device.

Claims

1. A vascular closure device for treating a passage in a blood vessel wall by closing a passage through tissue proximate to the blood vessel wall, the vascular closure device comprising:

an elongated housing having a proximal end, a distal end, and a distal section;

a plurality of engagement members which are each adapted to be secured to tissue upon deployment into tissue;

a plurality of deployment members adapted to extend from the distal section of the elongated housing in a distal and radially outward direction with distal most ends of the deployment members disposed in a distal and radially outward direction, each of the deployment members being adapted to deploy at least one of the engagement members into the tissue proximate to the blood vessel such that the engagement members are secured to the tissue proximate to the blood vessel and disposed at a distance from each other in engaged contact with said tissue, without engaging a portion of the blood vessel adjacent the tissue;

a plurality of elongate flexible tension elements, each tension element being secured to at least one engagement member;

a retraction member coupled in operative arrangement with the tension elements and adapted to apply axial tension to the tension elements and reduce the distance between the engagement members to a radially retracted state to close the passage in the tissue proximate to the blood vessel; and

a locking member adapted to secure the tension elements relative to each other with the tension elements in the retracted state thereby creating a tissue lock, the locking member comprising a preloaded self-retracting coil with an interior passage which is disposed about the tension elements, which is sized to allow free movement of the tension elements with the coil in an expanded state and which has an interior surface that is adapted to clench the tension elements when in a retracted state.

2. The vascular closure device according to claim 1, wherein the locking member is formed of a biodegradable and bio-absorbable material.

3. The vascular closure device according to claim 1, wherein the deployment members are adapted to deploy the engagement members in the tissue proximate to the blood vessel at a predetermined radial distance from the distal end of the vascular closure device.

4. The vascular closure device according to claim 1, wherein the engagement members are adapted to mechanically capture the tissue proximate to the blood vessel.

5. The vascular closure device according to claim 1, wherein the engagement members are adapted to rotate, pivot or expand once in engaged connection with the tissue.

6. The vascular closure device according to claim 5, wherein the engagement members each comprise a hypotube section having an inclined sharpened end portion.

7. The vascular closure device according to claim 1, wherein the engagement members are adapted to engage with a fascia membrane of said tissue.

8. The vascular closure device according to claim 1, wherein the elongate flexible tension members comprise sutures secured to the engagement members, and wherein the retraction member is adapted to retract the sutures toward a common position adjacent a surface of the tissue proximate the blood vessel in order to reduce the distance between the engagement members and associated tissue respectively engaged therewith.

9. The vascular closure device according to claim 8, wherein the sutures are formed of a biodegradable or bio-absorbable material.

10. The vascular closure device according to claim 1, wherein the engagement members are formed of a biodegradable or bio-absorbable material.

11. The vascular closure device according to claim 1, wherein the elongated housing further comprises a guidewire lumen allowing the vascular closure device to be advanced over a guidewire.

12. The vascular closure device according to claim 1, wherein the deployment members further comprise a spring-loaded portion adapted to project the engagement members into the tissue.

13. The vascular closure device according to claim 1, wherein the retraction member is adapted to apply a predetermined retraction force to the tension elements to thereby reduce the distance between the engagement members which have been secured to the tissue.

14. The vascular closure device according to claim 1, further comprising a tapered nosecone arranged at the distal end of the elongated housing.

15. A vascular closure device for closing a passage through tissue proximate to a blood vessel, the vascular closure device comprising:

an elongated housing having a proximal end and a distal end, the distal end adapted to be proximate the tissue;

a first and a second engagement member releasably arranged with the elongated housing;

a plurality of deployment members adapted to extend from the distal section of the elongated housing in a distal and radially outward direction with distal most ends of the deployment members disposed in a distal and radially outward direction, each of the deployment members being adapted to deploy at least one of the engagement members into the tissue proximate to the blood vessel such that the engagement members are secured to the tissue proximate to the blood vessel and disposed at a distance from each other in engaged contact with said tissue, without engaging a portion of the blood vessel adjacent the tissue;

a retraction member arranged with the elongated housing and adapted to reduce the distance between the first and the second engagement member to close said passage through tissue proximate to the blood vessel; and

a locking member adapted to secure tension elements relative to each other thereby creating a tissue lock with the tension elements being secured to the respective first and second engagement members and the locking member comprising a preloaded self-retracting coil with an interior passage which is disposed about the tension elements, which is sized to allow free movement of the tension elements with the coil in an expanded state and which has an interior surface that is adapted to clench the tension elements when in a retracted state.

16. The vascular closure device according to claim 15, wherein the first and the second engagement member are adapted to mechanically capture the tissue.

17. The vascular closure device according to claim 15, wherein the first and the second engagement member are adapted to engage with a fascia membrane of said tissue.

18. The vascular closure device according to claim 15, wherein the tension elements comprise sutures connected to the first and the second engagement member, and wherein the retraction member is adapted to retract the sutures to reduce the distance between the first and the second engagement member.