System and method for vessel access closure

• US 9,775,592 B2
• Filed: 12/08/2014
• Issued: 10/03/2017
• Est. Priority Date: 02/26/2010
• Status: Expired due to Fees

• Current Assignee: Promed, Inc.
• Original Assignee: Promed, Inc.
• Inventors: Ginn, Richard S., Domingo, Nicanor, Valencia, Hans F., Decou, Robert Elliott, Yerby, Scott
• Primary Examiner(s): LYNCH, ROBERT A
• Application Number:
  US14/563,685
• Publication Number:
  US 20150119930A1
• Time in Patent Office: 1,030 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 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/0061 Implements located only on one side of the opening
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/00942 hydrophilic
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2002/9534 for repositioning of stents

Abstract

Embodiments are described for closing vascular access ports, such as arteriotomies, which involve placement and deployment of an expandable device configured to prevent blood flow across a subject arteriotomy while also keeping disturbance of intravascular flow to a minimum. Suitable prostheses may comprise one or more frames constructed from lengths of flexible materials, such as shape memory alloys or polymers. Such frames may be coupled to sheetlike or tube-like structures configured to spread loads, minimize thrombosis which may be related to intravascular flow, and maintain hemostasis.

Claims

1. An apparatus for closing a hole in a vessel, comprising:

a. a delivery assembly comprising a delivery sheath and a foot member having proximal and distal portions and a flexible portion therebetween,

wherein the flexible portion is capable of accommodating rotation of the distal portion relative to the proximal portion,

b. a rotation activating member comprising an elongate bending spring member coupled to the proximal and distal portions of the foot member, said spring member being adapted to cause the distal portion of the foot member to rotate relative to the proximal portion of the foot member;

c. an implantable closure device having proximal and distal ends, the implantable device being removably coupled to the distal end of the foot member and being expandable from a collapsed state to an expanded state after the implantable device is inserted through the hole into a lumen defined by the vessel, the expanded state providing a geometry sufficient to substantially occlude the hole; and

d. an elongate member housed in said delivery assembly, a catch member coupled to said elongate member and configured to extend away from the proximal end of the implantable device by a catch member length, wherein the catch member length is selected to extend within the lumen to prevent withdrawal of the implantable closure device back through the hole.

2. The apparatus of claim 1, wherein the foot member having a proximal portion and a movable distal portion, the distal portion being coupled to the closure device, and wherein the distal portion may be moved from a first configuration wherein the distal portion is substantially aligned with the proximal portion, to a second configuration, wherein the distal portion is rotated relative to the proximal portion in a manner selected to prevent the closure device from exiting the opening in the blood vessel.

3. The apparatus of claim 2, wherein the movable distal portion or said foot member is biased to rotate to the second configuration when not constrained to remain in the first configuration.

4. The apparatus of claim 1, wherein the closure device is a self expanding structure configured to expand itself from the collapsed state to the expanded state when not restrained in the collapsed state.

5. The apparatus of claim 1, wherein the closure device expanded state forms a generally cylindrical shape defining a lumen therethrough.

6. The apparatus of claim 1, wherein the closure device comprises a frame structure and a cover member coupled to the frame structure in at least one location, wherein the frame structure is configured to retain a position within the blood vessel in its expanded state, and wherein the cover member has a thickness and is configured to at least temporarily resist the flow of blood across the thickness.

7. The apparatus of claim 1, wherein the catch member is pivotally coupled to said elongate member.

8. The apparatus of claim 1, wherein the catch member is controllably and movably coupled to the elongate member such that it may be reconfigured from a deployed configuration, wherein it extends to prevent withdrawal of the implantable closure device, to a retracted configuration, wherein it is retracted back toward the delivery sheath to facilitate removal of the delivery sheath back through the hole.