Coaxial dual lumen pigtail catheter

• US 8,613,706 B2
• Filed: 08/03/2007
• Issued: 12/24/2013
• Est. Priority Date: 03/10/2004
• Status: Active Grant

• Current Assignee: Vascular Solutions LLC (Teleflex Incorporated)
• Original Assignee: Phil Langston
• Inventors: Langston, Phil
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): TOTH, KAREN E
• Application Number:
  US11/890,070
• Publication Number:
  US 20080027334A1
• Time in Patent Office: 2,335 Days
• Field of Search: 600/481, 600/485, 600/486, 604/43
• 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 of a heart and an aorta of a patient across an aortic valve for diagnosis of aortic stenosis, the method comprising:

creating a percutaneous access to a major artery in a human body of the patient;

inserting a guidewire into the major artery and guiding the guidewire from the major artery through an aorta and into a left ventricle of the heart, the aorta and the left ventricle being separated by an aortic valve;

inserting a coaxial dual lumen pigtail catheter having a dual lumen portion and a single lumen portion along the guidewire, the single lumen portion having a first proximal straight portion, a second distal straight portion, a bend between the first proximal straight portion and the second distal straight portion and a pigtail portion, the single lumen portion having a constant fixed diameter along its length and the dual lumen portion having exactly two coaxial lumens along an entire length extending from a manifold to the single lumen portion;

advancing the coaxial dual lumen catheter until the pigtail portion of the single lumen portion and the second straight portion of the catheter are positioned in the left ventricle while the first straight portion of the single lumen portion bridges the aortic valve and extends into the aorta and the dual lumen portion is positioned partially in the aorta and extends to the exterior of the patient;

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 while the first straight portion of the single lumen portion bridges the aortic valve; 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 4, 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.