Perfusion dilatation catheter

• US 5,295,995 A
• Filed: 08/27/1992
• Issued: 03/22/1994
• Est. Priority Date: 08/27/1992
• Status: Expired due to Fees

• Current Assignee: Symmetry Medical Inc
• Original Assignee: Kleiman, Jay H.
• Inventors: Kleiman, Jay H.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Maglione, Corrine
• Application Number:
  US07/937,051
• Time in Patent Office: 572 Days
• Field of Search: 604/96, 604/101, 606/194 , 606/192
• US Class Current: 606/194
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

The present invention relates to angioplasty dilatation catheters. Specifically, the perfusion dilatation catheter of the present invention is used in coronary angioplasty, but it is equally applicable to renal, cerebral, and peripheral angioplasties. The catheter is comprised of a long flexible tubular shaft having an expandable balloon affixed near the distal end of the shaft and surrounding the circumference of the shaft. Upon expansion, the balloon'"'"'s cross-section is circumscribed by the circular perimeter of the target vessel cross-section. The balloon tip has a minimum of two rounded apices, wherein the maximum height of the apices does not exceed the nominal radius of the target vessel, and further wherein multiple radii of the balloon tip cross-section are of lesser radial dimension than the nominal radius of the target vessel. Thus, due to the unique shape and configuration of the balloon, a path for blood to flow past the balloon tip during expansion is formed through the areas of submaximal tip radial dimension. The remainder of the dilatation catheter incorporates conventional catheter features, including at least one lumen.

Claims

1. A dilatation catheter adapted for insertion into a target vessel and subsequent inflation therein, the catheter comprising:

a flexible elongated tubular shaft having proximal and distal ends defining at least one lumen and adapted for receiving a guide wire; and

,

an inflatable balloon affixed near said distal end of said shaft and surrounding the circumference of said shaft, said balloon having a wall of substantially constant thickness and at least two substantially rounded axial protrusions formed in said wall said protrusions having a common internal chamber with substantially no internal boundaries, wherein upon expansion of said balloon, said protrusions come into apposition with the walls of said target vessel, such that said balloon upon expansion, becomes non-circular, thereby forming blood flow paths around said protrusions.

2. The catheter of claim 1 wherein said target vessel has a nominal radius, and wherein said protrusions of said balloon, upon expansion, have a maximum height which does not exceed said nominal radius of said target vessel, and further wherein multiple radii of said balloon'"'"'s cross-section, said multiple radii extending from a center of said tubular shaft to an outer surface point of said balloon, are of lesser radial dimension than said nominal radius of said target vessel.

3. The catheter of claim 1 including a radiopaque marker affixed to said shaft.

4. The catheter of claim 1 wherein said lumen of said tubular shaft is in communication with or is integral with an interior of said balloon, said lumen providing for the inflation of said balloon.

5. The catheter of claim 1 wherein said tubular shaft has a first lumen extending longitudinally through said shaft and being out of communication with the interior of said balloon, and a second lumen in communication with or integral with said interior of said balloon, said second lumen providing for the inflation and deflation of said balloon.

6. The catheter of claim 5 wherein said first and second lumen are a thermo-plastic polymer.

7. The catheter of claim 5 wherein said second lumen provides a surface on which to carry said balloon.

8. A dilatation catheter adapted for insertion into a target vessel and subsequent inflation therein, the catheter comprising:

a flexible elongated tubular shaft having proximal and distal ends defining at least one lumen and adapted for receiving a guide wire;

an expandable, inflatable tip affixed near said distal end of said shaft and surrounding the circumference of said shaft, wherein upon expansion of said tip concentrically around said shaft, said tip has a cross-section circumscribed by a circular perimeter of a cross-section of said target vessel;

said target vessel having a nominal radius and said tip having a wall of substantially constant thickness and at least two rounded apices formed in said wall, said apices having a common internal chamber substantially with no internal boundaries, wherein a maximum height of said apices does not exceed said nominal radius of said target vessel, and further wherein multiple radii of said tip cross-section, said multiple radii extending from a center of said tubular shaft to an outer surface point of said tip, are of lesser radial dimension than said nominal radius of said target vessel;

wherein said tip, upon expansion, forms a path for blood to flow past said tip and through areas of submaximal tip radial dimension.

9. The catheter of claim 8 wherein said expandable tip is a balloon.

10. The catheter of claim 8 including a radiopaque marker affixed to said shaft.

11. The catheter of claim 8 wherein said lumen of said tubular shaft is in communication with or is integral with an interior of said tip, said lumen providing for the inflation of said tip.

12. The catheter of claim 8 wherein said tubular shaft has a first lumen extending longitudinally through said shaft and being out of communication with the interior of said tip, and a second lumen in communication with or integral with said interior of said tip, said second lumen providing for the inflation and deflation of said tip.

13. The catheter of claim 12 wherein said first and second lumen are a thermo-plastic polymer.

14. The catheter of claim 12 wherein said second lumen provides a surface on which to carry said tip.

15. A dilatation catheter adapted for insertion into a target vessel and subsequent inflation therein, the catheter comprising:

a flexible elongated tubular shaft having proximal and distal ends defining at least one lumen and adapted for receiving a guide wire;

an inflatable balloon tip affixed near said distal end of said shaft and surrounding the circumference of said shaft, said balloon tip having a wall of substantially constant thickness and at least two substantially rounded axial protrusions formed in said wall, said protrusions having a common internal chamber with substantially no internal boundaries, and wherein upon expansion of said balloon tip concentrically around said shaft, said balloon tip has a cross-section having at least two arcs of contact with said target vessel perimeter;

said target vessel having a nominal radius and said arcs having a radius which is substantially equal in length to said nominal radius of said target vessel, and further wherein said arcs have multiple areas of lesser radial dimension than said nominal radius of said target vessel;

said balloon tip, upon expansion, forming a path for blood to flow past said balloon tip and through areas of submaximal tip radial dimension.

16. The catheter of claim 15 including a radiopaque marker affixed to said shaft.

17. The catheter of claim 15 wherein said lumen of said tubular shaft is in communication with or is integral with an interior of said balloon, said lumen providing for the inflation of said balloon.

18. The catheter of claim 15 wherein said tubular shaft has a first lumen extending longitudinally through said shaft and being out of communication with the interior of said balloon, and a second lumen in communication with or integral with said interior of said balloon tip, said second lumen providing for the inflation and deflation of said balloon tip.

19. The catheter of claim 18 wherein said first and second lumen are a thermo-plastic polymer.

20. The catheter of claim 18 wherein said second lumen provides a surface on which to carry said balloon.