Blood vessel patch

• US 5,100,422 A
• Filed: 05/26/1989
• Issued: 03/31/1992
• Est. Priority Date: 05/26/1989
• Status: Expired due to Term

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: IMPRA Incorporated (Becton, Dickinson & Co)
• Inventors: Farnan, Robert C., Sinnott, Joseph B., Della Corna, Linda V., Berguer, Ramon, Kowligi, Rajagopal R., Colone, William M.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): Jackson, Gary
• Application Number:
  US07/358,785
• Time in Patent Office: 1,040 Days
• Field of Search: 623/1, 623/11, 623/12, 428/304.4, 428/308.4, 428/322.2, 428/207.0, 428/339, 428/411.1, 428/339, 128/155, 128/156, 606/151
• US Class Current: 606/151
• 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 17/07292 Reinforcements for staple line, e.g. pledgets
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: C08L 75/04 Polyurethanes
• CPC Class Codes: C08L 83/00 Compositions of macromolecular compounds obtained by reactions forming in the main chain of the macromolecule a linkage containing silicon with or without sulfur, nitrogen, oxygen or carbon only; Compositions of derivatives of such polymers

Abstract

A vascular patch for closing an incision in a blood vessel includes a base layer of expanded polytetrafluoroethylene (PTFE) having an outer coating of an elastomeric, biocompatible material such as polyurethane to minimize suture hole bleeding. Suture guidelines are formed upon the ablumenal side of the PFTE base layer prior to application of the elastomeric coating to facilitate proper and consistent placement of sutures. A colorant is added to the elastomeric coating to identify the ablumenal side of the vascular patch. The vascular patch is made by mounting an expanded PTFE tube upon a mandrel and applying a water based PFTE ink as a helical stripe about the outer surface of the PTFE tube to form the suture guidelines. The striped PTFE tube is then dip-coated or spray-coated with the elastomeric coating to which the colorant has been added. The PTFE tube is slit to form a flat sheet from which vascular patches are cut.

Claims

1. A vascular patch for patching incisions in blood vessels, comprising in combination:

a. a substantially planar layer of expanded PTFE having a first lumenal side for overlying a blood vessel and having a second opposing ablumenal side for facing away from the blood vessel; and

b. a non-porous elastomeric coating applied over at least the peripheral portions of the ablumenal side of the expanded PTFE layer to minimize suture hole bleeding resulting from the application of sutures to the vascular patch.

2. A vascular patch as recited by claim 1 wherein said elastomeric coating is applied over the entire ablumenal side of the expanded PTFE layer but not over the lumenal side of the expanded PTFE layer.

3. A vascular patch as recited by claim 1 wherein said elastomeric coating is a layer of polyurethane.

4. A vascular patch as recited by claim 3 wherein said polyurethane layer has a colorant therein to distinguish the uncoated lumenal side of the expanded PTFE layer from the coated ablumenal side of the expanded PTFE layer.

7. A vascular patch as recited by claim 4 wherein said indicia is comprised of PTFE ink.

8. A vascular patch as recited by claim 4 wherein said indicia includes suture guidelines for aiding a surgeon in the proper and consistent placement of sutures used to secure the patch to a blood vessel.

5. A vascular patch for patching incisions in blood vessels, comprising in combination:

a. a layer of expanded PTFE having a first lumenal side for overlying a blood vessel and having a second opposing ablumenal side for facing away from the blood vessel; and

b. a layer of polyurethane coated over the ablumenal side of the expanded PTFE layer but not over the lumenal side of the expanded PTFE layer, said polyurethane layer having a colorant therein to distinguish the uncoated lumenal side of the expanded PTFE layer from the coated ablumenal side of the expanded PTFE layer.

6. A vascular patch for patching incisions in blood vessels, comprising in combination:

a. a layer of expanded PTFE having a first lumenal side for overlying a blood vessel and having a second opposing ablumenal side for facing away from the blood vessel;

b. indicia formed upon the ablumenal side of the PTFE layer;

c. a layer of an elastomer coated over the ablumenal side of the expanded PTFE layer;

d. said indicia being visible through the layer of elastomer to distinguish the uncoated lumenal side of the expanded PTFE layer from the coated ablumenal side of the expanded PTFE layer.

9. A vascular patch as recited by claim 6 wherein said elastomer is selected from the group of elastomers consisting of medical-grade silicone rubber elastomers, segmented polyurethane, polyurethane-ureas, and silicone-polyurethane copolymers.

10. A vascular patch as recited by claim 6 wherein said elastomer has a hardness rating between 50A-100A and 55D-60.

11. A vascular patch for patching incisions in blood vessels, comprising in combination:

a. a substantially planer layer of expanded PTFE having a first lumenal side for overlying a blood vessel and having a second opposing ablumenal side for facing away from the blood vessel;

b. a non-porous layer of an elastomer coated over the ablumenal side of the expanded PTFE layer, said layer of elastomer being substantially transparent; and

c. said layer of expanded PTFE including a colorant proximate one of the lumenal or ablumenal sides thereof, said colorant distinguishing the uncoated lumenal side of the expanded PTFE layer from the coated ablumenal side of the expanded PTFE layer.