Coaxial dual lumen pigtail catheter

• US 20080027334A1
• Filed: 08/03/2007
• Published: 01/31/2008
• Est. Priority Date: 03/10/2004
• Status: Active Grant

• Current Assignee: Vascular Solutions LLC (Teleflex Incorporated)
• Original Assignee: Vascular Solutions Incorporated
• Inventors: Langston, Phil
• Granted Patent: US 8,613,706 B2
• Time in Patent Office: Days
• US Class Current: 600/486
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/02158 provided with two or more sensor elements
• CPC Class Codes: A61B 5/6857 with a distal pigtail shape
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked

Abstract

A method of measuring differential pressure between a left ventricle and an aorta across an aortic valve for diagnosis of aortic stenosis using a coaxial dual lumen pigtail catheter that utilizes coaxial construction incorporating a thin wall guiding catheter technology for the outer lumen and using a strong braided diagnostic technology for the central lumen to accommodate high-pressure injections. The catheter includes a manifold body to provide for connection to each of the dual lumens. The distal end of the coaxial dual lumen pigtail catheter tapers to a more flexible portion that is perforated by spiral side holes to provide for more undistorted pressure readings in the left ventricle. The coaxial dual lumen pigtail catheter also utilizes proximal straight sideholes at the end of the dual lumen portion and a taper between the dual lumen portion and the single lumen portion.

Claims

1. A method of measuring differential pressure between a left ventricle and an aorta across an aortic valve for diagnosis of aortic stenosis, the method comprising:

creating a percutaneous access to a major artery in a human body;

inserting a guidewire into the blood vessel and guiding the guidewire through an aorta and into the left ventricle of the heart;

inserting a coaxial dual lumen pigtail catheter along the guidewire until a pigtail portion of the catheter is positioned in the left ventricle;

withdrawing the guidewire from the catheter;

operably coupling a pressure measuring device in fluid communication with a first lumen and a second lumen of the catheter, the first lumen being in fluid communication with the left ventricle and the second lumen being in fluid communication with the aorta;

obtaining simultaneous pressure measurements from both the aorta and the left ventricle; and

determining a diagnostic pressure gradient across the valve by comparing the pressure measurements in the left ventricle and the aorta.

2. The method as claimed in claim 1, in which the determination of the diagnostic pressure gradient further comprises determining the diagnostic pressure gradient across the valve by comparing systolic peaks in the ventricle and the aorta.

3. The method as claimed in claim 1, further comprising measuring differential pressure between the ventricle and the aorta.

4. The method as claimed in claim 1, further comprising injecting a marker fluid through the first lumen into the ventricle.

5. The method as claimed in claim 1, further comprising observing the marker fluid whereby flow across the aortic valve is observed.

6. The method as claimed in claim 4, wherein the marker fluid comprises a radio opaque fluid.

7. The method as claimed in claim 6, further comprising observing the radio opaque fluid via fluoroscopy.

8. A method of manufacturing a coaxial dual lumen pigtail catheter, comprising:

forming a manifold portion including a first connector and a second connector;

connecting a dual lumen portion comprising an inner lumen wall defining an inner lumen in operable fluid communication with the first connector;

connecting an outer lumen wall defining an annular outer lumen in operable fluid communication with the second connector, and coaxial with the inner lumen;

perforating the outer lumen wall with a at least one outer lumen side hole proximate a distal end thereof;

connecting a single lumen portion comprising a first generally straight portion to the dual lumen portion;

perforating the single lumen portion with at least one inner lumen side hole proximate a distal end of the single lumen portion; and

forming a pigtail portion on the single lumen portion distal to the first generally straight portion.

9. The method as claimed in claim 8, further comprising tapering a portion of the catheter between the dual lumen portion and the single lumen portion.

10. The method as claimed in claim 9, further comprising distributing the inner lumen side holes in a generally spiral pattern over a section of the single lumen portion about two centimeters in length.

11. The method as claimed in claim 9, further comprising distributing the outer lumen side holes over a section of the dual lumen portion about four centimeters in length.

12. The method as claimed in claim 9, further comprising forming a second generally straight portion adjacent the first generally straight portion and joined thereto by a bend and forming a bend angle to be between about one hundred thirty degrees and one hundred sixty degrees.

13. The method as claimed in claim 9, further comprising forming the bend angle to be about one hundred forty five degrees.

14. The method as claimed in claim 9, further comprising forming the outer lumen wall using thin wall extrusion technology.

15. The method as claimed in claim 9, further comprising forming the inner lumen wall using braided extrusion technology to accommodate high-pressure injections at a pressure of at least about twelve hundred pounds per square inch.