Systems for applying cross-linked mechanical barriers

• US 6,994,686 B2
• Filed: 02/28/2001
• Issued: 02/07/2006
• Est. Priority Date: 08/26/1998
• Status: Expired due to Term

• Current Assignee: Neomend, Inc. (Becton, Dickinson & Co)
• Original Assignee: Neomend, Inc. (Becton, Dickinson & Co)
• Inventors: Hnojewyj, Olexander, Cruise, Gregory M
• Primary Examiner(s): Thanh, LoAn H.
• Application Number:
  US09/796,238
• Publication Number:
  US 20010031948A1
• Time in Patent Office: 1,805 Days
• Field of Search: 604507-509, 604/513, 604/514, 604/522, 604/57, 604/73, 604/82, 604/83, 604/84, 604/85, 604/91, 604/93.01, 604/94.01, 604/181, 604/182, 604186-187, 604/191, 604/199, 604207-208, 604/218, 604/225, 604/236, 604/238, 604/275, 606/93, 606/213, 222/137
• US Class Current: 604/82
• 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 2017/00495 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: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61L 24/043 Mixtures of macromolecular materials
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices artificial blood vessels A61L27/507
• CPC Class Codes: C08L 71/02 Polyalkylene oxides
• CPC Class Codes: C08L 89/00 Compositions of proteins; Compositions of derivatives thereof foodstuff preparations A23J3/00

Abstract

A delivery device applies a biocompatible and biodegradable barrier material to a tissue region, e.g., to seal a vascular puncture site. The material comprises two liquid components, which are pre-packaged in individual dispensers. Upon mixing, the liquid components cross-link to create a barrier matrix. A holder attaches to the delivery device. The holder mutually supports the first and second dispensers while the protein solution and polymer solution are conveyed from the dispensers into a fluid delivery channel. The protein and polymer solutions mix as a result of flow through the channel.

Claims

1. A system for applying a biocompatible, non-liquid barrier matrix to seal a vascular puncture site comprising

a catheter device defining a catheter tube movable into association with the vascular puncture site, the catheter tube including a distal end with an outlet, the catheter device including a positioner comprising an expandable structure on the distal end of the catheter tube to locate the outlet with respect to the vascular puncture site

a first dispenser containing a protein component,

a second dispenser containing a polymer component comprising poly(ethylene) glycol (PEG) with a functionality of at least three, and

an introducer attachable in communication with the catheter tube and including a holder to mutually support the first and second dispensers while conveying the protein and polymer components from the dispensers into the catheter tube for mixing as a result of flow through the catheter tube toward the outlet, wherein, upon mixing, the protein and polymer components chemically cross-link to form the non-liquid harder matrix at the vascular puncture site without the use of a photo initiator and ultraviolet light.

2. A system according to claim 1

wherein the structure expands in response to fluid pressure.

3. A system according to claim 1

wherein the structure expands in response to axial compression.

4. A system according to claim 1

wherein the expandable structure comprises a balloon.

5. A system according to claim 1,

wherein the catheter device includes a deformable region on the distal end located proximal to the outlet.

6. A system claim according to 1,

wherein the catheter tube includes an interior lumen to accommodate passage of a guide wire.

7. A system according to claim 1

wherein the introducer includes an actuator to mechanically link the dispensers to convey the protein and polymer components simultaneously into the catheter tube for mixing.

8. A system according to claim 1

wherein the protein component includes recombinant or natural serum albumin.

9. A system according to claim 1

wherein the PEG comprises a multi-armed polymer.

10. A system according to claim 1

wherein the dispensers comprise syringes.

11. A system according to claim 10

wherein the dispensers each include a piston advanceable to convey contents from the dispenser, and

wherein the introducer includes an actuator to mechanically link the pistons together for simultaneously advancement.

12. A system according to claim 1

and further including a kit for holding the dispensers prior to use.

13. A system according to claim 1 or 12

and further including a kit holding at least one of the catheter device and introducer prior to use.