Vascular guiding catheter assembly and vascular dilating catheter assembly and a combination thereof and methods of making the same

• US 4,323,071 A
• Filed: 05/19/1980
• Issued: 04/06/1982
• Est. Priority Date: 04/24/1978
• Status: Expired

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Catheter Systems Incorporated
• Inventors: Simpson, John B., Robert, Edward W.
• Primary Examiner(s): ROSENBAUM, C FRED
• Application Number:
  US06/151,175
• Time in Patent Office: 687 Days
• Field of Search: 128/656, 128/657, 128/658, 128/679, 128/692, 128/772, 128/214.4, 128/325, 128/341-344, 128/347-349 R, 128/349 B, 128/DIG. 9, 128/16, 128/18
• US Class Current: 606/194
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61M 2025/0047 the inner layer having a higher lubricity
• CPC Class Codes: A61M 2025/0048 with an outer layer made from silicon
• CPC Class Codes: A61M 2025/1077 having a system for expelling the air out of the balloon before inflation and use
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/1025 Connections between catheter tubes and inflation tubes
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/1034 Joining of shaft and balloon
• CPC Class Codes: A61M 25/1036 Making parts for balloon catheter systems, e.g. shafts or distal ends A61M25/1029 takes precedence
• CPC Class Codes: Y10S 128/18 Heat shrinkable film

Abstract

A combination guiding catheter assembly and a dilating catheter assembly. The guiding catheter assembly includes a first flexible tubular member formed of a material which has a low coefficient of friction and a second flexible tubular member encasing said first tubular member so that the first tubular member fits tightly in the second tubular member. The combined first and second tubular members have proximal and distal ends with a fitting mounted on the proximal end. The dilating catheter assembly includes a flexible tubular member. The tubular member of the dilating catheter assembly having proximal and distal ends and an inflatable annular portion formed integral with the tubular member of the dilating catheter assembly near the distal end thereof. A fitting is mounted on the proximal end of the tubular member of the dilating catheter assembly. The dilating catheter assembly is disposed within the guiding catheter assembly. An inflator is provided for inflating and deflating the inflatable annular portion.

Claims

1. In a combination of a guiding catheter assembly and a dilating catheter assembly, the guiding catheter assembly comprising a first flexible tubular member formed of a material which has a low coefficient of friction, a second flexible tubular member encasing said first tubular member so that the first tubular member fits tightly in the second tubular member, said combined first and second tubular members having proximal and distal ends and a fitting mounted on the proximal ends, the dilating catheter assembly comprising a flexible tubular member, said tubular member of said dilating catheter assembly having proximal and distal ends and an inflatable annular portion formed integral with the tubular member of said dilating catheter assembly near the distal end thereof, a fitting mounted on the proximal end of the tubular member of the dilating catheter assembly, said dilating catheter assembly being disposed within said guiding catheter assembly and means for inflating and deflating said inflatable annular portion.

2. A combination as in claim 1 wherein the second tubular member of said guiding catheter assembly of said guiding catheter assembly has greater rigidity than said first tubular member.

3. A combination as in claim 2 wherein said first tubular member of the guiding catheter assembly is formed of a tetrafluoroethylene polymer.

4. A combination as in claim 1 wherein said first and second tubular members of said dilating catheter assembly are coaxial.

5. In a combination of a guiding catheter assembly and a dilating catheter assembly, a guiding catheter assembly comprising a first flexible tubular member formed of a material which has a low coefficient of friction below 0.05, a second flexible tubular member encasing said first tubular member so that the first tubular member fits tightly in the second tubular member to combine the first and second tubular members, said combined first and second tubular members having proximal and distal ends and a fitting mounted on the proximal end, the dilating catheter assembly comprising first and second tubular members, said first tubular member of said dilating catheter assembly surrounding said second tubular member of said dilating catheter assembly surrounding said second tubular member of said dilating catheter assembly, said first tubular member of said dilating catheter assembly having proximal and distal ends and an inflatable annular portion formed integral with the tubular member near the distal end thereof, means forming a fluid-tight seal between the first and the second tubular members of the dilating catheter assembly in a region between the inflatable annular portion and the distal ends of the first and second tubular members of the dilating catheter assembly, a fitting mounted on the proximal ends of the first and second tubular members of the dilating catheter assembly, means forming a fluid passageway from the proximal ends of the first and second tubular members of the dilating catheter assembly extending into the inflatable annular portion, said dilating catheter assembly being disposed within said guiding catheter assembly and means for inflating said inflatable annular portion with a radiographic contract liquid.

7. A guiding catheter assembly as in claim 5 wherein said first flexible tubular member is formed of a tetrafluoroethylene polymer.

6. In a guiding catheter assembly, a first flexible tubular member formed of a material which has a low coefficient of friction and having a guiding passageway extending therethrough, a second flexible tubular member encasing said first tubular member so that the first tubular member fits tightly in said second tubular member, and so that the second tubular member is coextensive in length with the first tubular member, said second tubular member being formed of a plastic material which is flexible but which has a greater rigidity than said first tubular member so as to provide a catheter assembly with the desired rigidity to permit manuevering of the same, the first and second tubular members having proximal and distal ends the distal ends each having a bend therein, a fitting mounted on the proximal ends to permit access to the passage in the first tubular member and an additional tubular member engaging the fitting and the proximal ends with a shrink fit to form an adhesive-free liquid-tight connection between the fitting and the proximal ends.

8. A guiding catheter assembly as in claim 6 wherein the distal end of the second tubular member is provided with an annular recess.

9. A guiding catheter assembly as in claim 8 wherein the distal end of the second tubular member is provided with an annular recess.

10. In a dilating catheter assembly for use with a radiographic contrast liquid, a flexible tubular member and having proximal and distal ends, said tubular member having an inflatable annular portion formed integral therewith adjacent the distal end and a fitting carried by the proximal end and means permitting the introduction of a radiographic contrast liquid for inflating said inflatable annular portion and the removal of said radiographic contrast liquid to deflate said annular portion.

11. In a dilating catheter assembly, a first flexible tubular member formed of a flexible plastic material and serving as an inner catheter, a second flexible tubular member, said second tubular member encasing said first tubular member so that said first and second tubular members are coaxially aligned, said first and second tubular members having proximal and distal ends, said second tubular member having a balloon-shaped portion formed therein adjacent the distal end and a fitting carried by the proximal ends for permitting insertion and withdrawal of a fluid for inflating and deflating the balloon-shaped portion of the second tubular member.

12. An assembly as in claim 11 in which the first and second tubular members are formed of a heat-shrinkable plastic.

13. An assembly as in claim 12 wherein the distal ends of the first and second tubular members are bonded together to form a fluid-tight adhesive free seal.

14. An assembly as in claim 12 wherein the first and second annular members are formed so that an annular flow passage extends therebetween from the proximal ends to the inflatable annular portion.

15. An assembly as in claim 12 in which the inflatable annular portion is integral with the second tubular member.

16. An assembly as in claim 15 in which the inflatable annular portion has a wall thickness substantially less than the wall thickness of the second tubular member.

17. In combination, a dilating catheter assembly having proximal and distal ends, the dilating catheter assembly having an inflatable annular member near the distal end and having a first flow passage leading from the proximal end to the inflatable annular member, a removable tubular member disposed within the dilating catheter assembly and providing a second flow passage extending from the proximal end into the inflatable annular member and means for introducing a radiographic contrast liquid into the inflatable annular member by using one of said first and second flow passages to introduce the liquid into the inflatable annular member to fill the same and to thereby force all air out of the inflatable annular member through the other of the first and second flow passages.

18. A combination as in claim 17 wherein the second tubular member is removed after the inflatable annular member has been inflated.

19. A combination as in claim 17 wherein said removable tubular member is in the form of a flushing tube and wherein the radiographic contrast liquid is introduced into the inflatable annualar member through the flushing tube.

20. In a method for inflating a dilating catheter assembly having a first tubular member with an inflatable annular portion near the distal end thereof and having a first flow passage leading from the proximal end to the inflatable annular portion, placing a second tubular member in said first flow passage of said first tubular member forming a seal between the first and second tubular members between the inflatable annular portion and the distal ends and providing a second flow passage extending from the inflatable annular portion to the proximal end, introducing a radiographic contrast liquid into one of said first and second flow passages to fill the inflatable annular portion with the radiographic contrast liquid and to thereby force air out of the inflatable annular portion and out through the other of the first and second flow passages.

21. A method as in claim 20 wherein the radiographic contrast fluid is introduced through the second flow passage provided in the tubular member.