Systems, methods, and compositions for achieving closure of vascular puncture sites

• US 7,279,001 B2
• Filed: 05/08/2002
• Issued: 10/09/2007
• Est. Priority Date: 11/06/1998
• Status: Expired due to Fees

• Current Assignee: Neomend, Inc. (Becton, Dickinson & Co)
• Original Assignee: Neomend, Inc. (Becton, Dickinson & Co)
• Inventors: Hnojewyj, Olexander, Addis, Bruce, Milo, Charles
• Primary Examiner(s): Hayes; Michael J.
• Assistant Examiner(s): Mendoza; Michael G.
• Application Number:
  US10/141,510
• Publication Number:
  US 20030100921A1
• Time in Patent Office: 1,980 Days
• Field of Search: 606213-215, 604/181, 604/183, 604/184, 604/191, 604/57, 604/58, 604/148, 604/15, 604/82
• US Class Current: 606/214
• 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 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like

Abstract

Systems and methods convey a closure material into a catheter, e.g., to seal a puncture site in a blood vessel. The closure material comprises a mixture of first and second components, which, upon mixing, undergo a reaction to form solid closure material composition. The first component may be a lyophilized polyethylene glycol (PEG) material contained within a vial. The second component may be a buffered albumin solution plus water contained within a syringe. An applicator provides easy and effective mixing of the components and delivery of the mixture to the puncture site.

Claims

1. An assembly comprising

a biocompatible polymer in lyophilized form,

a first container holding the polymer in lyophilized form, the first container including a fluid receiving end,

a protein solution,

a second container holding the protein solution including a fluid dispensing end and a single actuator for expelling the protein solution from the fluid dispensing end, and

applicator to join the fluid receiving end of the first container with the fluid dispensing end of the second container to introduce the protein solution into the first container for mixing with the polymer in lyophilized form to reconstitute the polymer and form a mixture, wherein, upon mixing, the protein solution and the polymer cross-link, the applicator including a first fluid passage adapted to join the fluid dispensing end of the second container in fluid communication with the fluid receiving end of the first container, the first fluid passage including a distal end region that, when the fluid dispensing end of the second container is joined in fluid communication with the fluid receiving end of the first container, extends into the first container to contact the polymer in lyophilized form, the distal end region including a plurality of holes in a side of the distal end region for uniformly introducing the protein solution into the first container for mixing with the polymer in response to operation of the single actuator, the applicator further including a second fluid passage next to the first fluid passage for conveying the mixture from the first container concurrent with introduction of the protein solution into the first container in response to operation of the single actuator.