Medical device and a method for sealing a puncture or an opening

摘要

The invention is generally directed to devices and methods for sealing a puncture or an opening through a wall of a blood vessel or a body cavity. The device includes a structural member and a sealing material associated with the structural member. The structural member includes a rod, a first obstructing body and a second obstructing body. The first obstructing body is affixed against an inner surface of the wall of the blood vessel or body cavity and the second obstructing body is affixed against an outer surface of the wall of the blood vessel or body cavity once placed at the puncture or the opening. The sealing material includes a reconstituted or naturally-derived collagenous material, which can expand at the puncture or the opening to restore hemostasis and enhance sealing.

主权项

1. A medical device for immediate sealing of a puncture or an opening through a wall of a blood vessel or a body cavity, comprising:
a) a structural member which can be in a first collapsed configuration and in a second expanded configuration, the structural member comprising
i) an elongated member having a distal end and a proximal end, wherein at least a portion of the elongated member comprises protruding structural elements;ii) a first obstructing body disposed on the distal end of the elongated member and having a first obstructing body perimeter enclosing a substantially solid surface; andiii) a second obstructing body having a second obstructing body perimeter enclosing a substantially solid surface capable of being translated along the portion of the elongated member comprising the protruding structural elements for adjusting a distance between the first and the second obstructing bodies; and b) a remodelable sealing material associated with the structural member comprising a reconstituted or naturally-derived collagenous material wherein the collagenous material encourages and promotes tissue ingrowth at the puncture or the opening, wherein the sealing material is attached to or lining at least a portion of at least one of the elongated member, the first obstructing body and the second obstructing body, wherein the sealing material is substantially enclosed within the structural member once the structural member is in the expanded configuration and deployed at the puncture or the opening; wherein the first and the second obstructing bodies are opposing each other once the structural member is in the expanded configuration, wherein the first obstructing body is configured to be affixed against an inner surface of the wall of the blood vessel or body cavity so that at least the first obstructing body perimeter is in a continuous contact with the inner surface of the wall of the blood vessel or body cavity and the second obstructing body is configured to be affixed against an outer surface of the wall of the blood vessel or body cavity so that at least the second obstructing body perimeter is in a continuous contact with the outer surface of the wall of the blood vessel or body cavity, once the structural member is in the expanded configuration and deployed at the puncture or the opening to immediately seal the puncture or the opening and substantially prevent leakage through the puncture or the opening, and wherein the first and the second obstructing bodies are configured to biodegrade or detach following the tissue ingrowth and the closure of the puncture or opening.