Systems and methods for applying cross-linked mechanical barriers

• US 20010031948A1
• Filed: 02/28/2001
• Published: 10/18/2001
• Est. Priority Date: 08/26/1998
• Status: Active Grant

• Current Assignee: Neomend, Inc. (Becton, Dickinson & Co)
• Original Assignee: Neomend, Inc. (Becton, Dickinson & Co)
• Inventors: Hnojewyj, Olexander, Cruise, Gregory M.
• Granted Patent: US 6,994,686 B2
• Time in Patent Office: Days
• US Class Current: 604/191
• 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 in contact with a tissue region a biocompatible, non-liquid barrier matrix comprising

a delivery device defining a fluid delivery channel movable into association with the tissue region,

a first dispenser containing a protein solution,

a second dispenser containing a polymer solution including a derivative of a hydrophilic polymer with a functionality of at least three, and

an introducer attachable in communication with the fluid delivery channel and including a holder to mutually support the first and second dispensers while conveying the protein solution and polymer solution from the dispensers into the fluid delivery channel for mixing as a result of flow through the channel, wherein, upon mixing, the protein solution and the polymer solution cross-link to form the non-liquid barrier matrix.

2. A system according to

claim 1

wherein the introducer includes an actuator to mechanically link the dispensers to convey the protein solution and the polymer solution simultaneously into the fluid delivery channel for mixing.

3. A system according to

claim 1

wherein the delivery device comprises a cannula.

4. A system according to

claim 1

wherein the delivery device comprises a sprayer.

5. A system according to

claim 1

wherein the delivery device comprises a catheter tube.

6. A system according to

claim 1

wherein the dispensers comprise syringes.

7. A system according to

claim 6

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.

8. A system according to

claim 1

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

9. A system according to

claim 1

or

8

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

10. A system according to

claim 1

wherein the protein solution includes recombinant or natural serum albumin.

11. A system according to

claim 1

wherein the polymer includes poly(ethylene) glycol (PEG).

12. A system according to

claim 11

wherein the PEG comprises a multi-armed polymer.

13. A system according to

claim 1

and further including instructions for applying the non-liquid barrier matrix to seal a vascular puncture site.

14. 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,

a first dispenser containing a first liquid component,

a second dispenser containing a second liquid component, the first and second liquid components being free of an enzyme, 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 first and second liquid 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 first and second liquid components chemically cross-link to form the non-liquid barrier matrix at the vascular puncture site.

15. A system according to

claim 14

wherein the catheter device includes a positioner on the distal end of the catheter tube to locate the outlet with respect to the vascular puncture site.

16. A system according to

claim 15

wherein the positioner is located distally of the outlet.

17. A system according to

claim 15

wherein, in use, the positioner is located inside the blood vessel while the outlet is located outside the blood vessel.

18. A system according to

claim 15

wherein the positioner comprises an expandable structure on the distal end.

19. A system according to

claim 18

wherein the structure expands in response to fluid pressure.

20. A system according to

claim 18

wherein the structure expands in response to axial compression.

21. A system according to

claim 18

wherein the expandable structure comprises a balloon.

22. A system according to

claim 18

wherein the expandable structure comprises a basket.

23. A system according to

claim 14

,

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

24. A system claim according to 14,

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

25. A system according to

claim 14

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

26. A system according to

claim 14

wherein the first liquid component includes a protein solution.

27. A system according to

claim 26

wherein the protein solution includes recombinant or natural serum albumin.

28. A system according to

claim 14

wherein the second liquid component includes a polymer solution.

29. A system according to

claim 28

wherein the polymer solution includes poly(ethylene) glycol (PEG).

30. A system according to

claim 29

wherein the PEG comprises a multi-armed polymer.

31. A system according to

claim 14

wherein the dispensers comprise syringes.

32. A system according to

claim 31

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.

33. A system according to

claim 14

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

34. A system according to

claim 14

or

33

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

35. An apparatus for dispensing a biocompatible barrier material comprising a mixture of a protein component and a polymer component, which, upon mixing, cross-link to form a mechanical barrier matrix, the apparatus comprising

a holder to support a first dispenser containing the protein component and a second dispenser containing the polymer component, free of mixing,

an actuator linking the first dispenser and second dispenser to cause simultaneous dispensement of the protein component and the polymer component from the dispensers in the holder,

a joiner coupled to the holder to convey the simultaneously dispensed protein component and polymer component, free of mixing, and

a mixer coupled to the joiner to receive the simultaneously dispensed protein component and polymer component and defining a channel in which the protein and polymer components mix.

36. An apparatus according to

claim 35

, wherein the mixer includes an outlet to dispense the mixture.

37. An apparatus according to

claim 36

, wherein the outlet comprises a spray head.

38. An apparatus according to

claim 36

, wherein the outlet includes a fitting to couple the outlet to a lumen of a catheter tube.

39. An apparatus according to

claim 36

, wherein the outlet includes a fitting to couple the outlet to a cannula.