Wire reinforced articulation segment

• US 7,004,937 B2
• Filed: 07/31/2002
• Issued: 02/28/2006
• Est. Priority Date: 07/31/2002
• Status: Active Grant

• Current Assignee: CryoCor Incorporated (Boston Scientific Corporation)
• Original Assignee: CryoCor Incorporated (Boston Scientific Corporation)
• Inventors: Estepa, Phillip A., Lentz, David J.
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US10/210,616
• Publication Number:
  US 20040024413A1
• Time in Patent Office: 1,308 Days
• Field of Search: 606/108, 606/1, 606 20- 26, 606/129, 604/264, 604523-284
• US Class Current: 606/22
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0262 using a circulating cryogenic fluid
• 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

Abstract

A device for steering a cardiac cryoablation catheter through the vasculature of a patient includes separate first and second deflection members that connect a tip member to the distal end of a catheter tube. Importantly, the first deflection member has a first flexural modulus, and the second deflection member has a second flexural modulus that is greater than the first flexural modulus. Also included is a control wire for pulling the tip member toward the catheter tube. In response, the first and second deflection members differentially deflect, according to their respective flexural moduli, to move the tip member for steering the catheter through the vasculature.

Claims

1. A device for steering a cardiac cryoablation catheter through the vasculature and heart of a patient which comprises:

a resilient, cylindrical-shaped articulation segment defining a longitudinal axis, said articulation segment having a distal end and a proximal end and forming a lumen therebetween;

a tip member affixed to the distal end of said articulation segment;

a flexible spine fixedly attached to said articulation segment to extend between the proximal and distal ends thereof, and oriented on said articulation segment off-set from the axis thereof and substantially parallel thereto;

a control wire having a first end attached to said tip member, wherein the first end of said control wire is attached to said tip member at an attachment point between the axis of the articulation segment and a location opposite to said spine, said control wire being positioned in the lumen of said articulation segment to extend a second end of said control wire from the proximal end of said articulation segment; and

a means engaged with the second end of said control wire for axially moving said control wire to selectively deflect said tip member, said articulation segment and said spine through an arc in a plane to steer the catheter.

2. A device as recited in claim 1 wherein said articulation segment has a first flexural modulus, said spine is a wire having a second flexural modulus and, with said second flexural modulus of said spine being greater than said first flexural modulus of said articulation segment to establish a direction for deflection of said tip member.

3. A device as recited in claim 1 wherein said device further comprises a catheter tube having a distal end and a proximal end, and wherein said distal end of said catheter tube is attached to said articulation segment and said proximal end of said catheter tube is attached to said means for moving said control wire.

4. A device as recited in claim 1 wherein said spine and the axis of said articulation segment define a plane, with said spine having a first radius of curvature in the plane during a deflection thereof and the axis having a second radius of curvature in the plane during a deflection of said articulation segment, and wherein the first radius of curvature is greater than the second radius of curvature.

5. A device as recited in claim 1 wherein the arc has an arc length greater than approximately two radians during a deflection of said articulation segment.

6. A device as recited in claim 1 wherein said articulation segment has a length greater than approximately ten millimeters.

7. A device as recited in claim 1 further comprising a pivot arm mounted on said means for moving said control wire, said pivot arm being connected to the second end of said control wire for axially moving said control wire.

8. A device as recited in claim 1 wherein said tip member is made of a thermo-conductive material and said device further comprises:

a refrigeration source for generating a sub-cooled fluid; and

a transfer tube extending through the lumen of said articulation segment to interconnect said refrigeration source in fluid communication with said tip member.

9. A device as recited in claim 1 wherein said articulation segment comprises:

a helical spring defining the lumen;

an inner tube positioned against said helical spring inside the lumen; and

an outer tube positioned against said helical spring opposite said inner tube, said outer tube being bonded to said inner tube to embed said helical spring between said inner tube and said outer tube.

10. A device as recited in claim 9 wherein said inner tube and said outer tube are made of a Pebax material.

11. A device for steering a cardiac cryoablation catheter through the vasculature and heart of a patient which comprises:

a tip member made of a thermo-conductive material;

a catheter tube having a proximal end and a distal end;

a first deflection member attached to said tip member and to the distal end of said catheter tube to position said first deflection member therebetween, said first deflection member having a first flexural modulus;

a second deflection member attached to said tip member and to the distal end of said catheter tube to position said second deflection member substantially parallel to said first deflection member between said tip member and said catheter tube, said second deflection member having a second flexural modulus with the second flexural modulus being greater than the first flexural modulus;

a control means for pulling said tip member toward said catheter tube to differentially deflect said first deflection member and said second deflection member according to the respective flexural moduli to move said tip member for steering said catheter through the vasculature;

a refrigeration source for generating a sub-cooled fluid; and

a transfer tube extending through the lumen of said articulation segment to interconnect said refrigeration source in fluid communication with said tip member.

12. A device as recited in claim 11 wherein said first deflection member is a resilient, cylindrical-shaped articulation segment defining a longitudinal axis, said articulation segment having a distal end and a proximal end and forming a lumen therebetween, and wherein said second deflection member is a flexible spine fixedly attached to said articulation segment to extend between the proximal and distal ends thereof, and oriented on said articulation segment off-set from the axis thereof and substantially parallel thereto.

13. A device as recited in claim 12 wherein the control means includes a control wire attached to said tip member at an attachment point between the axis of the articulation segment and a location diametrically opposite said spine.

14. A device as recited in claim 12 wherein said articulation segment comprises:

a helical spring defining the lumen;

an inner tube positioned against said helical spring inside the lumen; and

an outer tube positioned against said helical spring opposite said inner tube, said outer tube being bonded to said inner tube to embed said helical spring between said inner tube and said outer tube.

15. A method for manufacturing a device for steering a cardiac cryoablation catheter through the vasculature and heart of a patient which comprises the steps of:

providing a helical spring having a proximal end and a distal end, the helical spring defining an axis and forming a lumen;

positioning an inner tube in the lumen of the helical spring;

positioning an outer tube against the helical spring opposite the inner tube;

bonding the outer tube to the inner tube to embed the helical spring therebetween to create a resilient, cylindrical-shaped articulation segment, with the articulation segment having a first flexural modulus;

fixedly attaching a flexible spine to said articulation segment to extend between the proximal and distal ends thereof, said spine being oriented on said articulation segment off-set from the axis thereof and substantially parallel thereto, with the spine having a second flexural modulus wherein the second flexural modulus is greater than the first flexural modulus;

affixing a tip member to the distal end of the articulation segment; and

attaching a control wire to the tip member to differentially deflect the articulation segment and the spine according to their respective flexural moduli, whenever the control wire is pulled, to move the tip member for steering the catheter through the vasculature.

16. A method as recited in claim 15 wherein the control wire is attached to the tip member at an attachment point between the axis of the articulation segment and a location diametrically opposite the spine.

17. A method as recited in claim 15 wherein the inner tube and the outer tube are made of a Pebax material.

18. A method as recited in claim 15 wherein the tip member is made of a thermo-conductive material and the method further comprises the step of connecting a refrigeration source in fluid communication with the tip member, wherein the refrigeration source is used for generating a sub-cooled fluid.