Expandable occlusion apparatus

• US 4,413,989 A
• Filed: 08/17/1981
• Issued: 11/08/1983
• Est. Priority Date: 09/08/1980
• Status: Expired due to Term

• Current Assignee: Schneider Electric SE
• Original Assignee: Angiomedics Corporation
• Inventors: Schjeldahl, Gilmore T., Sharma, B.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Wallen, T. J.
• Application Number:
  US06/293,466
• Time in Patent Office: 813 Days
• Field of Search: 604/4, 604/7, 604/8, 604/9, 604/41, 604/44, 604/52, 604/93, 604/95, 604/96, 604/99, 604/104, 128/341
• US Class Current: 604/103.13
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• 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 25/104 used for angioplasty

Abstract

A catheter assembly or catheter attachment for use in treatment of coronary artery disease resulting from atheromatous lesions whereby stenotic lesions can be dilated without interruption to the blood supply distal to the stenotic lesion being treated, the catheter further allowing blood pressure distal to the site to be measured throughout the treatment procedure. In one form of the invention, the catheter assembly comprises first and second coaxial telescoping tubes, the outer tube having a pattern of perforations through its side wall proximate the distal end thereof and an inelastic expander member sealed to its outer surface at spaced apart locations so as to span the pattern of perforations. The patient'"'"'s own blood may be perfused through the lumen of the outer tube between the outer surface of the inner tube and the inner surface of the outer tube and through the pattern of perforations to uniformly expand the inelastic expander member. The inner and outer tubes are tapered at their distal ends so as to facilitate insertion of the catheter assembly through a blood vessel and, by relative longitudinal displacement of the inner tube with respect to the outer tube, the pressure and rate of flow of blood from the open distal end of the catheter can be controlled from its proximal end. In an alternative arrangement, the inner tube is replaced with a cylindrical wire of a predetermined diameter less than the inner diameter of said outer tube. Further, the distal end portion of the outer tube may be made distensible so that it can be made to expand by applying a suitable pressure at the proximal end of the catheter, and the catheter may be provided with a highly flexible guidance pigtail for facilitating the insertions of the instrument into a blood vessel, without interfering with the expanding and perfusing functions of the instrument.

Claims

1. A catheter attachment for facilitating coronary transluminal angioplasty/coronary perfusion procedures, comprising:

(a) an elongated outer tubular member having at least one perforation proximate the distal end thereof;

(b) a generally non-elastic, hollow, expander member surrounding said outer tubular member proximate said distal end and sealingly connected to said outer tubular member at longitudinally spaced apart locations on either side of said perforation; and

(c) an elongated inner tubular member of a predetermined diameter less than the inner diameter of said outer tubular member and disposed within the lumen of said outer tubular member and extending from the proximal end thereof beyond the distal end thereof, the arrangement being such that a fluid introduced at said proximal end of said outer tubular member perfuses between said outer and inner tubular members, through said perforation to fill the volume of said expander member and out the distal end of said outer tubular member.

2. The catheter attachment as in claim 1 wherein said outer tubular member tapers to a lesser diameter a predetermined distance proximal the distal end thereof.

3. The catheter attachment as in claim 2 wherein said elongated outer tubular member has an outer diameter generally in the range of from 0.5 to 5 millimeters and wherein said lesser diameter is in the range of from 0.025 to 5.0 millimeters.

4. The catheter attachment as in claim 1 wherein said inner tubular member tapers to a lesser diameter from a predetermined distance proximal said distal end of said inner tubular member to said distal end thereof.

5. The catheter as in claim 4 wherein said inner tubular member is longitudinally displaceable within the lumen of said outer tubular member from a location near said proximal end of said outer tubular member.

6. The catheter attachment as in claim 5 wherein the longitudinal displacement of said inner tubular member within the lumen of said outer tubular member controls the perfusion rate of fluid therebetween and the pressure acting on the wall surface of said expander member.

7. The catheter attachment as in claim 4 wherein said elongated inner tubular member has an outer diameter generally in the range of from 0.2 to 3.0 millimeters and wherein said lesser diameter is in the range of from 0.16 to 2.4 millimeters.

8. Apparatus as in claim 1 wherein said non-elastic expander member comprises a longitudinally extending thin, flexible, tubular element formed from a biaxially oriented synthetic plastic material surrounding said outer tubular member with opposed ends thereof secured to said outer tubular member at spaced apart locations proximate said distal end thereof.

9. Apparatus as in claim 8 wherein said synthetic plastic material is polypropylene.

10. The catheter attachment as in claim 8 wherein said expander member, when expanded, has a continuous taper from a relatively large diameter middle zone thereof to a lesser diameter at said opposed ends of said expander member.

11. The catheter attachment as in claim 10 wherein said relatively large diameter of said middle zone of expander member is in the range of from 1.0 to 30.0 millimeters and wherein the length of said expander member between said sealed connections to said outer tubular member is in the range of from 5 to 100 millimeters.

12. The catheter attachment as in claim 8 wherein said expander member, when expanded, tapers continuously from an enlarged cross-sectional dimension inward of said distal end to a lesser cross-sectional dimension proximate said distal end.

13. The catheter attachment as in claim 8 wherein said expander member and said outer tubular member surrounded thereby form a generally smooth curve.

14. The catheter attachment as in claim 8 wherein said expander member, when expanded, has a continuous taper from a relatively large diameter proximal end toward a relatively small diameter distal end.

15. The catheter attachment as in claim 8 wherein said expander member, when expanded, includes at least two bifurcated branches.

16. The catheter attachment as in claim 8 wherein said expander member, when expanded, imparts a curve to portion of said outer tubular member surrounded by said expander member.

17. The catheter attachment as in claim 1 wherein said outer and said inner tubular members are formed from synthetic plastic materials selected from the class including polyurethane, polyvinylchloride and polyethylene.

18. The catheter attachment as in claim 1 and further including a predetermined length of wire reinforced high-torque tubing attached to the proximal end of said outer tubular member for facilitating the application of twisting forces to said outer tubular member during the insertion of said catheter through a blood vessel.

19. The catheter attachment as in claim 1 and further including a radiopaque coating on the inside surface of said generally non-elastic, hollow, expander member.

20. A catheter attachment for facilitating coronary transluminal angioplasty/coronary perfusion procedures, comprising:

(a) an enlongated expander mounting tube having at least one perforation proximate the distal end thereof;

(b) a generally non-elastic, hollow, expander member surrounding said elongated expander member proximate said distal end and sealingly connected to said expander mounting tube at longitudinally spaced apart locations on either side of said perforation; and

(c) an elongated generally cylindrical member of a predetermined diameter less than the inner diameter of said expander mounting tube and disposed within the lumen of said expander mounting tube and extending from the proximal end thereof beyond the distal end thereof, the arrangement being such that a fluid introduced at said proximal end of said expander mounting tube perfuses between said expander mounting tube and said cylindrical member, through said perforation to fill the volume of said expander member and out the distal end of said expander mounting tube.

21. The catheter attachment as in claim 20 wherein said cylindrical member comprises a generally solid, flexible wire.

22. The catheter attachment as in claim 20 wherein said elongated cylindrical member has a tubular cross-section.

23. The catheter attachment as in claim 20 wherein said expander mounting tube is formed from a soft, distensible, plastic material.

24. The catheter attachment as in claim 23 wherein the portion of said expander member sealingly connected to said expander mounting tube on the distal side of said perforation is generally non-distensible.

25. The catheter attachment as in claim 24 and further including a high-torque tube secured to the proximal end of said expander mounting tube.

26. A catheter attachment for use in treatment of coronary artery disease, comprising:

(a) an outer tubular member formed from a distensible, soft plastic material and having a central lumen a distal end and a proximal end and a relatively expandable segment formed thereon displaced a predetermined distance proximal of said distal end; and

(b) an elongated generally cylindrical member of a predetermined diameter less than or equal to the inner diameter of said outer tubular member and disposed within the central lumen of said outer tubular member and extending from said proximal end thereof beyond said distal end thereof, the arrangement being such that a fluid introduced at said proximal end of said outer tubular member perfuses between said outer tubular member and said elongated generally cylindrical member to distend said relatively expandable segment to a desired diameter and out said distal end of said outer tubular member.

27. The catheter attachment as in claim 26 wherein said expandable segment is integrally formed in said outer tubular member.

28. The catheter attachment as in claim 27 wherein said elongated generally cylindrical member is a generally solid, flexible, wire member.

29. The catheter attachment as in claim 27 wherein said outer tubular member has a predetermined distensibility less than the distensibility of said relatively expandable segment in the portion of said outer tubular member distal of said expandable segment.

30. The catheter attachment as in claim 29 and further including a high-torque tube of a predetermined diameter secured to said proximal end of said outer tubular member.

31. A catheter comprising, in combination:

(a) a first, tubular member having an open end;

(b) a second member of smaller diameter slidable within said first member to define a lumen between the inner wall of the first member and the outer wall of the second member;

(c) valving means carried by said second member near one end thereof for engaging the second end of said first member and preventing access to said lumen lumenn;

(d) and flexible guide means extending from the last named means in a direction away from said first member.

32. A catheter according to claim 31 in which said second member is tubular and said valve means comprises an enlargement on the end thereof, and in which a side port is provided in said second member near said enlargement for enabling communication between said lumen and the interior of said second member.

33. A catheter according to claim 31 in which said second member is tubular and said guide means includes a central core having a generally spherical enlargement near one end to be received in said second member and enlarging the same to comprise said valving means.