Steerable balloon catheter

• US 7,351,214 B2
• Filed: 10/23/2003
• Issued: 04/01/2008
• Est. Priority Date: 03/22/2002
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Burgermeister, Robert
• Primary Examiner(s): Hindenburg; Max F.
• Assistant Examiner(s): HOEKSTRA, JEFFREY GERBEN
• Application Number:
  US10/691,824
• Publication Number:
  US 20040193205A1
• Time in Patent Office: 1,622 Days
• Field of Search: 600/585, 600/453, 600/434, 600/435, 600/433, 600/549, 604/103.09, 604/103, 604/95.01, 604/525, 604/530, 604/264, 604/508, 604/509, 604/95.03, 604/96.01, 604/97.01, 604/98.01, 604/99.01, 604/104, 604/164.03, 604/164.13, 604/528, 604/6.13, 604/290
• US Class Current: 600/585
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/09008 having a balloon
• CPC Class Codes: A61M 2025/09083 having a coil around a core
• CPC Class Codes: A61M 2025/09133 having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/09033 with fixed mandrils, e.g. mandrils fixed to tip; Tensionable wires
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

A steerable balloon catheter including a balloon catheter supported by a steerable guidewire having a deflectable distal tip. The guidewire comprises a longitudinal hypotube and a spring coil attached to the distal end of the hypotube and includes a longitudinally movable deflection member which is attached to the distal end of the spring coil and a tip retaining member which extends from the distal end of the hypotube to the distal end of the spring coil for providing very precise deflection of the distal tip of the balloon catheter.

Claims

1. A steerable balloon catheter having a deflectable tip which comprises:

an inner elongated flexible hollow tubing having proximal and distal portions;

a flexible helical coil having proximal and distal ends, the proximal end of said helical coil is attached to the distal portion of the inner elongated flexible hollow tubing;

an elongated deflection member having proximal and distal portions and being slidably disposed within said inner elongated flexible hollow tubing and within said helical coil, the distal portion of said deflection member being flattened to form a deflection ribbon which extends in a plane;

a retaining ribbon having proximal and distal ends, the proximal end of the retaining ribbon is attached to the distal portion of the inner elongated flexible hollow tubing and the retaining ribbon is oriented to extend in a plane which is generally parallel to the plane of the deflection ribbon;

an attachment member engaging the distal end of the helical coil, the distal portion of the deflection member, and the distal end of the retaining ribbon so that longitudinal movement of the deflection member in a distal direction causes the distal end of the helical coil to be deflected in one direction and longitudinal movement of the deflection member in a proximal direction causes the distal end of the helical coil to deflect in another opposite direction;

the attachment member takes the form of a rounded bead which contacts the distal end of the helical coil to define a curved surface at the distal end of the coil;

the deflection ribbon engages the rounded bead at a location offset from the center of the curved surface of the rounded bead;

the distal end of the retaining ribbon engages the rounded bead at a location offset from the center of the curved surface of the rounded bead;

said deflection ribbon and said retaining ribbon being joined together to form a generally U-shaped configuration;

an outer elongated flexible tubing surrounding the inner elongated hollow tubing so as to define a passageway between the outer tubing and the inner elongated flexible hollow tubing; and

an inflatable balloon mounted on the outer flexible tubing and communicating with the passageway between the outer tubing and the inner hollow tubing.

2. A steerable balloon catheter as defined in claim 1, wherein the retaining ribbon and the deflection ribbon are normally biased in an arcuate configuration to thereby cause the distal end of the helical coil to be normally biased in a curved shape.

3. A steerable balloon catheter as defined in claim 1, wherein the proximal portion of said deflection member is of a circular cross section which extends from the proximal portion of the inner flexible tubing to approximately the distal portion of the inner flexible tubing.

4. A steerable balloon catheter as defined in claim 3, wherein the proximal end of said retaining ribbon extends from the distal portion of the inner flexible tubing to approximately the distal end of the flexible helical coil.

5. A steerable balloon catheter as defined in claim 1, wherein the rounded bead is formed with an epoxy material.

6. A steerable balloon catheter as defined in claim 1, wherein the distal end of the retaining ribbon engages the rounded bead at a location offset from the center of the circular surface in an opposite direction from the offset location of the deflection ribbon.

7. A steerable balloon catheter as defined in claim 6, wherein the deflection member and the retaining ribbon are joined to each other within the rounded bead.

8. A steerable balloon catheter as defined in claim 7, wherein the deflection ribbon and the retaining ribbon are formed as a single unitary element.

9. A steerable balloon catheter as defined in claim 1, wherein the deflection ribbon and the retaining ribbon provide a predetermined spacing between the deflection ribbon and the retaining ribbon and to maintain the deflection ribbon and the retaining ribbon in planes which are parallel to each other.

10. A steerable balloon catheter as defined in claim 1, wherein the deflection ribbon is formed by flattening an intermediate portion of the deflection member and the retaining ribbon is formed by flattening the distal portion of the deflection member.

11. A steerable balloon catheter as defined in claim 10, wherein the retaining ribbon is of a thickness which is less than the thickness of the deflection ribbon.

12. A steerable balloon catheter as defined in claim 11, wherein the deflection ribbon is of a thickness equal to about 0.002 inches and the retaining ribbon is of a thickness equal to about 0.0015 inches.

13. A steerable balloon catheter having a deflectable tip which comprises:

an inner elongated flexible hollow tubing having proximal and distal portions;

a flexible helical coil having proximal and distal ends, the proximal end of said helical coil is attached to the distal portion of the inner elongated flexible hollow tubing;

an elongated deflection member having proximal and distal portions and being slidably disposed within said hollow tubing and within said helical coil, the distal portion of said deflection member being tapered;

an elongated retaining member having proximal and distal ends, the proximal end of the retaining member is attached to the distal portion of the flexible hollow tubing;

an attachment member engaging the distal end of the helical coil, the deflection member, and the distal end of the retaining member so that longitudinal movement of the deflection member in a distal direction causes the distal end of the helical coil to be deflected in one direction and longitudinal movement of the deflection member in a proximal direction causes the distal end of the helical coil to deflect in an opposite direction;

said retaining member being preshaped into an arcuate configuration to thereby cause the flexible helical coil to be normally biased into a curved shape;

an outer elongated flexible tubing surrounding the inner elongated hollow tubing so as to define a passageway between the outer elongated flexible tubing and the inner elongated hollow tubing; and

,

an inflatable balloon mounted on the outer elongated tubing and the communicating with the passageway between the outer tubing and the inner tubing.

14. A steerable balloon catheter as defined in claim 13, wherein the attachment member takes the form of a rounded bead.

15. A steerable balloon catheter as defined in claim 13, wherein a portion of the attachment member extends across the distal end of the helical coil, the distal portion of the deflection member engages the attachment member at a location offset from the center of the attachment member extending across the distal end of the helical coil.

16. A steerable balloon catheter as defined in claim 15, wherein the distal end of the retaining member engages the attachment member at a location offset from the center of the attachment member extending across the distal end of the helical coil.

17. A steerable balloon catheter as defined in claim 16, wherein the distal end of the retaining member engages the attachment member at a location offset from the center of the attachment member in an opposite direction from the offset location of the deflection member.

18. A steerable balloon catheter as defined in claim 13, wherein the deflection member and the retaining member are joined to each other within the attachment member.

19. A steerable balloon catheter as defined in claim 18, wherein the deflection member and the retaining member are formed as a single unitary element.

20. A steerable balloon catheter as defined in claim 19, wherein the junction between the deflection member and the retaining member form a generally U-shaped configuration to thereby provide a predetermined spacing between the distal portion of the deflection member and the distal end of the retaining member.

21. A steerable balloon catheter as defined in claim 20, wherein the attachment member takes the form of a rounded bead.

22. A steerable balloon catheter having a deflectable tip which comprises:

a first elongated flexible hollow tubing having proximal and distal portions;

a flexible helical coil having proximal and distal ends, the proximal end of said helical coil is attached to the distal portion of the first elongated flexible hollow tubing;

an elongated deflection member comprised of proximal and distal portions and being slidably disposed within said hollow tubing and within said helical coil, the proximal portion of the deflection member being of a cylindrical cross section and the distal portion of said deflection member takes the form a deflection ribbon which extends in a plane;

a retaining ribbon having proximal and distal ends, the proximal end of the retaining ribbon is attached to the distal portion of the first elongated flexible hollow tubing and the retaining ribbon is oriented to extend in a plane which is generally parallel to the plane of the deflection ribbon;

an attachment member engaging the distal end of the helical coil, the distal portion of the deflection member, and the distal end of the retaining ribbon so that longitudinal movement of the deflection member in a distal direction causes the distal end of the helical coil to be deflected in one direction and longitudinal movement of the deflection member in a proximal direction causes the distal end of the helical coil to deflect in another opposite direction;

wherein the attachment member takes the form of a rounded bead which contacts the distal end of the helical coil to define a curved surface at the distal end of the coil, and the deflection ribbon engages the rounded bead at a location offset from the center of the rounded surface of the rounded bead; and

wherein the distal end of the retaining ribbon engages the rounded bead at a location offset from the center of the rounded surface of the rounded bead, said retaining ribbon being offset from the center of the rounded surface in an opposite direction from the offset location of the deflection ribbon;

said deflection ribbon and retaining ribbon being joined to each other within the rounded bead;

a second elongated flexible tubing attached to and supported by said first elongated flexible hollow tubing, said second tubing having an inflation lumen; and

an inflatable balloon mounted on said second elongated flexible tubing and communicating with the lumen of said second elongated tubing.

23. A steerable balloon catheter as defined in claim 22, wherein the retaining ribbon and the deflection ribbon are normally biased in an arcuate configuration to thereby cause the distal end of the helical coil to be normally biased in a curved shape.

24. A steerable balloon catheter as defined in claim 22, wherein the distal portion of the deflection member and the deflection ribbon are formed from a wire of a circular cross section and in which the distal portion is flattened to form a deflection ribbon.

25. A steerable balloon catheter as defined in claim 22, wherein the deflection ribbon and the retaining ribbon are joined to form a generally U-shaped configuration to thereby provide a predetermined spacing between the deflection ribbon and the retaining ribbon and to maintain the deflection ribbon and the retaining ribbon in planes which are parallel to each other.

26. A steerable balloon catheter as defined in claim 25, wherein the deflection ribbon is formed by flattening an intermediate portion of the deflection member and the retaining ribbon is formed by flattening a distal portion of the deflection member.

27. A steerable balloon catheter as defined in claim 26, wherein the retaining ribbon is of the thickness which is less than the thickness of the deflection ribbon.

28. A steerable balloon catheter as defined in claim 22, wherein the proximal portion of the elongated flexible tubing is coupled to a control handle and the elongated deflection member is mounted with the control handle for longitudinal movement.

29. A steerable balloon catheter as defined in claim 28, wherein said control handle includes a movable knob which is coupled to the elongated deflection member for longitudinal positioning of the deflection member.

30. A steerable balloon catheter as defined in claim 29, wherein said control handle is coupled to the elongated flexible tubing with a release mechanism so that the handle may be removed from the guidewire.