BALLOON-TYPE CATHETERS AND METHOD OF MANUFACTURE

• US 3,625,793 A
• Filed: 09/23/1969
• Issued: 12/07/1971
• Est. Priority Date: 09/23/1969
• Status: Expired due to Term

• Current Assignee: Malco Incorporated St Louis Missouri
• Original Assignee: David S. Sheridan, Isaac S. Jackson
• Inventors: Sheridan, David S., Jackson, Isaac S.
• Primary Examiner(s): Quarforth, Carl D.
• Assistant Examiner(s): Lechert, Jr., Stephen J.
• Application Number:
  US04/860,278
• Time in Patent Office: 805 Days
• Field of Search: 156/293,294,296,303.1,229,83,250,257 128/349
• US Class Current: 156/229
• CPC Class Codes: A61M 16/0434 Cuffs
• CPC Class Codes: A61M 16/0459 one cuff behind another
• CPC Class Codes: A61M 16/0486 Multi-lumen tracheal tubes
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 25/001 Forming the tip of a catheter, e.g. bevelling process, join or taper
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: B29C 48/0019 combined with shaping by flattening, folding or bending
• CPC Class Codes: B29C 48/0022 combined with cutting
• CPC Class Codes: B29C 48/09 Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
• CPC Class Codes: B29C 48/10 flexible, e.g. blown foils
• CPC Class Codes: B29C 48/13 Articles with a cross-section varying in the longitudinal direction, e.g. corrugated pipes
• CPC Class Codes: B29C 57/00 Shaping of tube ends, e.g. flanging, belling or closing; Apparatus therefor , e.g. collapsible mandrels
• CPC Class Codes: B29L 2031/7542 Catheters
• CPC Class Codes: Y10T 156/1064 Partial cutting [e.g., grooving or incising]

Abstract

Disposable balloon-type catheters are made from tubes of extruded waterproof plastic having a major lumen and at least one secondary lumen within the tube wall. Such secondary lumens are joined for fluid flow to inflation tubes by a series of cutting and cementing steps and to elastic inflatable balloons which are fitted in special fashion to the distal end of the tube.

Claims

2. A method as claimed in claim 1 wherein liquid cement is applied at the ends of said tubular extensions around the walls of said tube to form beaded joints between the tube and the balloon.

3. Method for the production of balloon-type catheters which comprises:

a. providing an extruded tube of predetermined length formed of flexible waterproof plastic material, said tube comprising a major lumen and a secondary lumen, said major lumen having an area equal to at least one-half the cross-sectional area of the tube, said secondary lumen being of smaller diameter than the wall thickness of the tube, both said lumens extending the full length of the tube, b. cutting a first opening through the wall of said tube adjacent the distal end thereof into communication with said secondary lumen, c. closing said secondary lumen at the distal tip of said tube while leaving the secondary lumen open for fluid flow proximal of said first opening, d. sealing an elastic inflatable balloon to the outside of said tube so as to envelope said first opening, e. cutting a second opening through the wall of said tube into communication with said secondary lumen between said first opening and the proximal end of the tube, f. providing a section of extruded tubing of predetermined length having an outside diameter larger than said secondary lumen, g. inserting a heated tapered mandrel into said second opening to cause said lumen to be expanded in the region of said second opening, h. removing said mandrel from said second opening, inserting promptly one end of said section of extruded tubing into the expanded said second opening, and i. allowing said second opening to contract about said inserted end of tubing.

4. A method as claimed in claim 3 wherein a layer of liquid cement is applied to said one end of tubing section before inserting said tubing into said second opening in step '"'"''"'"''"'"''"'"'i.'"'"''"'"''"'"''"'"'

5. A method as claimed in claim 3 wherein said closing of the secondary lumen in step '"'"''"'"''"'"''"'"'c'"'"''"'"''"'"''"'"' is accomplished by forcing the end of the tube into a mold heated to a temperature sufficient to produce plastic flow of the plastic material of the tube, said mold having a concave contour to create a smooth convex surface upon the tube end in the step of closing of the secondary lumen.

6. A method as claimed in claim 5 wherein the distal tip of said tube is cut at an angle to the longitudinal axis of the tube and said mold is complimentarily contoured to create a smoothly rounded tapered distal end tip on the balloon-type catheter.

7. A method as claimed in claim 6 wherein said catheter is an endotrachael tube and the tube provided in step '"'"''"'"''"'"''"'"'a'"'"''"'"''"'"''"'"' has a permanent arcuate shape.

8. A method as claimed in claim 6 wherein air within said mold is allowed to escape therefrom through an air bleed hole that extends through a wall of said mold.

9. A method as claimed in claim 4 wherein said tube is made of plasticized polyvinyl chloride having an extrusion temperature about 300*-350* F. and said tapered mandrel is heated to a temperature about 160*-200* F.