Blood vessel patch

• US 5,104,400 A
• Filed: 08/28/1991
• Issued: 04/14/1992
• 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., Berguer, Ramon, Kowligi, Rajagopal R., Colone, William M., Sinnott, Joseph B., Della Corna, Linda V.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): Jackson, Gary
• Application Number:
  US07/751,877
• Time in Patent Office: 230 Days
• Field of Search: 623/1, 128/DIG. 4, 128/156, 264/41, 264/46.9, 264/49, 264/215, 264/216, 264/310, 264/512, 264/74, 264/509, 264/512, 264/132, 264/136, 264/146, 264/309, 264/310, 428/36.8, 428/36.9, 428/36.91, 428/58, 428/295, 428/57, 428/421
• US Class Current: 264/132
• 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: A61B 2017/00526 Methods of manufacturing
• 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 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• 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 27/56 Porous materials, e.g. foams or sponges
• 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
• CPC Class Codes: Y10T 428/3154 Of fluorinated addition polymer from unsaturated monomers

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 PTFE 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 PTFE 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 method of producing a vascular patch form an expanded porous PTFE tube having opposing inner and outer cylindrical walls, said method comprising the steps of:

a. coating the outer cylindrical wall of the PTFE tube with a liquified elastomer without coating the inner cylindrical wall thereof, to form an elastomeric coating upon the outer cylindrical wall of the PTFE tube;

b. drying the elastomeric coating;

c. cutting the cylindrical wall of the PTFE tube along its length to provide a relatively flat sheet of material; and

d. cutting a vascular patch form the flat sheet.

2. The method of producing a vascular patch as recited by claim 1 wherein said coating step includes the steps of mounting the PTFE tube upon a mandrel, and dipping the mandrel in a container of the liquified elastomer.

3. The method of producing a vascular patch as recited by claim 1 wherein said coating step includes the steps of mounting the PTFE tube upon a mandrel, and spraying the liquified elastomer upon the outer cylindrical wall of the PTFE tube.

4. The method of producing a vascular patch as recited by claim 1 wherein the liquified elastomer is selected from the group of elastomers consisting of consisting of medical-grade silicone rubber elastomers, segmented polyurethanes, polyurethane-ureas, and silicone-polyurethane copolymers.

5. The method of producing a vascular patch as recited by claim 1 further including the step of adding a colorant to the liquified elastomer prior to said coating step to add a color to the elastomeric coating, thereby identifying an ablumenal side of the vascular patch.

6. The method of producing a vascular patch as recited by claim 1 further including the step of marking indicia upon the outer cylindrical wall of the PTFE tube prior to said coating step to aid in the identification of an ablumenal side of the vascular patch.

7. The method of producing a vascular patch as recited by claim 6 wherein said marking step includes the step of applying stripes of PTFE ink upon the outer cylindrical wall of the PTFE tube prior to said coating step, said stripes running generally perpendicular to a central axis of the PTFE tube to form suture guidelines upon an ablumenal side of the vascular patch for aiding a surgeon in the proper and consistent placement of sutures.

8. The method of producing a vascular patch as recited by claim 7 wherein said stripe application step includes the step of rotating the mandrel while moving a PTFE ink pen linearly along the outer cylindrical wall of the PTFE tube generally parallel to the central axis of the PTFE tube to form a continuous helical stripe upon the outer cylindrical wall of the PTFE tube.

9. A method of manufacturing a vascular patch form an expanded porous PTFE tube, the PTFE tube having a cylindrical wall with an outer surface, said method comprising the steps of:

a. mounting an expanded PTFE tube on a cylindrical mandrel;

b. coating the outer surface of the cylindrical wall of the PTFE tube with a liquified elastomer to form an elastomeric coating thereon;

c. drying the elastomeric coating;

d. cutting the cylindrical wall of the PTFE tube along the length of the PTFE tube;

e. laying the cut PTFE tube relatively flat to form a generally planar sheet; and

f. cutting the vascular patch from the generally planar sheet.

10. The method recited by claim 9 further including the step of adding a colorant to the liquified elastomer prior to said coating step for adding a color to the elastomeric coating and thereby identifying an ablumenal side of the vascular patch.

11. The method recited by claim 9 wherein the liquified elastomer is selected from the group of elastomers consisting of medical-grade silicone rubber elastomers, segmented polyurethanes, polyurethane-ureas, and silicone-polyurethane copolymers.

12. The method recited by claim 9 wherein said coating step includes the step of dipping the mandrel into a container of the liquified elastomer.

13. The method recited by claim 9 wherein said coating step includes the steps of rotating the mandrel while spraying the liquified elastomer upon the outer surface of the cylindrical wall of the PTFE tube.

14. The method recited by claim 9 including the step of applying stripes of PTFE ink upon the outer surface of the cylindrical wall of the PTFE tube prior to said coating step, said stripes running generally perpendicular to the central axis of the PTFE tube to form suture guidelines upon an ablumenal side of the vascular patch, the suture guidelines aiding a surgeon in the proper and consistent placement of sutures and aiding in the identification of the ablumenal side of the vascular patch.

15. The method recited by claim 14 wherein said stripe application step includes the step of rotating the mandrel while moving a PTFE ink pen linearly along the outer surface of the cylindrical wall of the PTFE tube generally parallel to the central axis of the PTFE tube to form a continuous helical stripe upon the outer surface thereof.