Universal introducer

• US 6,733,515 B1
• Filed: 03/10/1998
• Issued: 05/11/2004
• Est. Priority Date: 03/12/1997
• Status: Expired due to Term

• Current Assignee: Neomend, Inc. (Becton, Dickinson & Co)
• Original Assignee: Neomend, Inc. (Becton, Dickinson & Co)
• Inventors: Parker, Theodore L., Wehman, Thomas C., Kucklick, Theodore, Lax, Ronald, Edwards, Stuart D.
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US09/037,659
• Time in Patent Office: 2,254 Days
• Field of Search: 604/20, 604/21, 604/41, 604/278, 604/501, 604/506, 604/507, 604/508, 604/48, 604/93.01, 604/113, 604/114, 604/158, 604/164.01, 604/181, 604/187, 604/218, 604/264, 604/523, 606/213, 606/214-215, 606/32-33, 606/27-31, 607/96-102, 607/115, 607/154
• 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 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 18/1487 Trocar-like, i.e. devices producing an enlarged transcutaneous opening
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61B 2017/005 hardenable using external energy source, e.g. laser, ultrasound
• 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 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/3441 with distal sealing means
• CPC Class Codes: A61B 2017/3492 against the outside of the body
• CPC Class Codes: A61B 2018/0063 Sealing
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

A device for introducing a catheter into a vessel through a puncture in a vessel and for sealing the puncture. The device includes an elongated body having a proximal end and a distal end sized to be positioned within a tissue site which includes the puncture. The elongated body includes a utility lumen sized to allow a catheter to be delivered through the utility lumen. The utility lumen is positioned within the elongated body so positioning the elongated body within the tissue site allows a catheter delivered through the utility lumen to enter the vessel. The elongated body also includes a closure lumen having an entrance port. A closure composition can be delivered through the entrance port into the closure lumen. The closure lumen also includes an exit port adjacent the distal end of the elongated body. The closure composition delivered into the closure lumen can be delivered through the exit port to the tissue site adjacent the puncture.

Claims

1. An apparatus having a distal end, the apparatus sized and configured for introducing a catheter instrument through a vessel puncture site and introducing a closure composition to seal the vessel puncture site after removal of the catheter instrument, the apparatus comprising

a unitary elongated body adapted for passage through a tissue puncture and having an end region defining the distal end of the apparatus and adapted to occupy a position adjacent the vessel puncture site, the body including a circumferential wall having an inner surface and an outer surface,

a first lumen in the elongated body, the first lumen being defined by the inner surface of the circumferential wall and accommodating passage of a catheter instrument through the vessel puncture site and removal of the catheter instrument from the vessel puncture site,

a closure composition comprising a combination of closure components which, when combined, react to form the closure composition,

a second lumen in the elongated body separate from the first lumen and being defined by a bore within the circumferential wall between the inner and outer surfaces, the second lumen having a fluid delivery port located at a fixed distance from the distal end of the apparatus, the second lumen being adapted for introducing the closure composition to seal the vessel puncture site after removal of the catheter instrument, and

one or more dispensers in fluid communication with the second lumen for dispensing the closure components as a combination that reacts in situ to form the closure composition adjacent the vessel puncture site,

the first and second lumens being at least partially free of communication with each other.

2. The assembly of claim 1

wherein the closure components include a matrix component.

3. The assembly of claim 2

wherein the matrix component is a biocompatible material.

4. The assembly of claim 3

wherein the biocompatible material is selected from a group consisting essentially of proteins, saccharides, mucopolysaccharides, mucoproteins and proteoglycans, and synthetic polymer conjugates.

5. The assembly of claim 2

wherein the matrix component includes ionizable functional groups that increase compatibility of the matrix component with water-based solvents.

6. The assembly of claim 2

wherein the matrix component includes chemical functionalities that are reactive with themselves and each other.

7. The assembly of claim 6

wherein the chemical functionalities are selected from a group consisting essentially of a carboxy group, an amino group, a thiol group, a disulfide group, a hydroxy group, an ester group, and an amide group.

8. The assembly of claim 1

wherein the closure components include a conductivity enhancing material.

9. The assembly of claim 8

further including an electrode on the elongated body to conduct electrical energy through the conductivity enhancer to increase rate of formation of the closure composition.

10. The assembly of claim 8

wherein the conductivity enhancer includes physiologic saline.

11. The assembly of claim 8

wherein the conductivity enhancer functions as a physiologic buffer.

12. The assembly of claim 8

wherein the conductivity enhancer includes at least one of an inorganic ionic salt and an organic ionic salt.

13. The assembly of claim 1

wherein the closure components include a composition vehicle.

14. The assembly of claim 13

wherein the composition vehicle includes water.

15. The assembly of claim 1

wherein the closure components include a matrix component, a conductivity enhancing material, and a composition vehicle.

16. The assembly of claim 15

wherein the matrix component is a biocompatible material.

17. The assembly of claim 16

wherein the biocompatible material is selected from a group consisting essentially of proteins, saccharides, mucopolysaccharides, mucoproteins and proteoglycans, and synthetic polymer conjugates.

18. The assembly of claim 15

wherein the matrix component includes ionizable functional groups that increase compatibility of the matrix component with water-based solvents.

19. The assembly of claim 15

wherein the matrix component includes chemical functionalities that are reactive with themselves and each other.

20. The assembly of claim 19

wherein the chemical functionalities are selected from a group consisting essentially of a carboxy group, an amino group, a thiol group, a disulfide group, a hydroxy group, an ester group, and an amide group.

21. The assembly of claim 15

further including an electrode on the elongated body to conduct electrical energy through the conductivity enhancer to increase rate of formation of the closure composition.

22. The assembly of claim 15

wherein the conductivity enhancer includes physiologic saline.

23. The assembly of claim 15

wherein the conductivity enhancer functions as a physiologic buffer.

24. The assembly of claim 15

wherein the conductivity enhancer includes at least one of an inorganic ionic salt and an organic ionic salt.

25. The assembly of claim 15

wherein the composition vehicle includes water.