Dual port thermodilution catheter and method for manufacture

• US 5,443,074 A
• Filed: 11/16/1994
• Issued: 08/22/1995
• Est. Priority Date: 01/21/1992
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: Taimisto, Miriam, Roelandt, Robert, Lieber, Clement E.
• Primary Examiner(s): JONES, MARYBETH O
• Application Number:
  US08/341,327
• Time in Patent Office: 279 Days
• Field of Search: 128/642, 128/668, 128/673, 128/691, 128/692, 128/713, 128/736, 604/102, 604/164, 604/180
• US Class Current: 600/526
• CPC Class Codes: A61B 5/028 by thermo-dilution
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• 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 catheter for monitoring heart function comprises a catheter tube having a plurality of lumens. The catheter includes an inflatable balloon at a distal tip of the catheter tube for positioning the catheter in a wedged position within a pulmonary artery within the heart of a patient. Dual injectate ports are formed in a side wall of the catheter tube. Each port communicates with a respective injectate lumen carried in the catheter tube. When inserted into the heart of a patient, either the first or second injectate port is positioned within the desired distance from the tricuspid valve for thermodilution depending upon the size of the heart. Thermodilution to obtain cardiac output and/or right heart ejection fraction is implemented by injecting injectate through the lumen associated with the port properly positioned relative the tricuspid valve and discharged through the corresponding port.

Claims

1. A bolus thermodilution catheter for use in monitoring heart function by injecting fluid into the right atrium and measuring fluid temperature downstream, said catheter comprising an inflatable balloon for positioning a distal end of said catheter in a pulmonary artery, said catheter additionally comprising plural lumens and corresponding plural injectate ports for injecting fluid proximal to the tricuspid valve of the heart, a first of said injectate ports being located closer to said balloon than a second of said injectate ports, said plural injectate ports being spaced from each other within the range of 3-4 cm to accommodate hearts of different sizes, so that one of said injectate ports is positioned proximal to the tricuspid valve in the right atrium when said balloon is in said pulmonary artery.

2. The catheter of claim 1, wherein each of said injectate ports comprises an array of closely spaced openings.

3. The catheter of claim 2, wherein said array consists of three openings.

4. The catheter of claim 1, wherein the first injectate port is spaced from the balloon within the range of 19-21 cm.

5. A method of manufacturing a bolus thermodilution catheter, said method comprising:

forming a catheter having plural injectate lumens and an inflatable balloon for positioning a distal end of the catheter in a pulmonary artery;

forming openings in a wall of said catheter to provide plural injectate ports for receiving fluid from said plural injectate lumens, respectively; and

locating said injectate ports within the range of 3-4 cm from each other to accommodate hearts of different sizes such that one of the injectate ports is proximal to the tricuspid valve in the right atrium for a relatively large heart and another of the injectate ports is proximal to the tricuspid valve in the right atrium for a relatively small heart.

6. A bolus thermodilution catheter for use in monitoring heart function by injecting fluid into the right atrium and measuring fluid temperature downstream, said catheter comprising an inflatable balloon for positioning a distal end of said catheter in a pulmonary artery, said catheter additionally comprising plural lumens and corresponding plural injectate ports for injecting fluid proximal to the tricuspid valve of the heart, a first of said injectate ports being located closer to said balloon than a second of said injectate ports, said plural injectate ports being spaced from each other by about 7 cm to accommodate hearts of different sizes, so that one of said injectate ports is positioned proximal to the tricuspid valve in the right atrium when said balloon is in said pulmonary artery.

7. The catheter of claim 6, wherein the first injectate port is spaced from the balloon within the range of 9-13 cm.

8. A bolus thermodilution catheter for use in monitoring heart function by injecting fluid into the right atrium and measuring fluid temperature downstream, said catheter comprising an inflatable balloon for positioning a distal end of said catheter in a pulmonary artery, said catheter additionally comprising plural lumens and corresponding plural injectate ports for injecting fluid proximal to the tricuspid valve of the heart, a first of said injectate ports being located closer to said balloon than a second of said injectate ports, said plural injectate ports being spaced from each other within the range of 15-20% of the distance between the first injectate port and the balloon to accommodate hearts of different sizes, so that one of said injectate ports is positioned proximal to the tricuspid valve in the right atrium when said balloon is in said pulmonary artery.

9. A method of manufacturing a bolus thermodilution catheter, said method comprising:

forming a catheter having plural injectate lumens and an inflatable balloon for positioning a distal end of the catheter in a pulmonary artery.

forming openings in a wall of said catheter to provide plural injectate ports for receiving fluid from said plural injectate lumens, respectively; and

locating said injectate ports about 7 cm from each other to accommodate hearts of different sizes such that one of the injectate ports is proximal to the tricuspid valve in the right atrium for a relatively large heart and another of the injectate ports is proximal to the tricuspid valve in the right atrium for a relatively small heart.

10. A method of manufacturing a bolus thermodilution catheter, said method comprising:

forming a catheter having plural injectate lumens and an inflatable balloon for positioning a distal end of the catheter in a pulmonary artery.

forming openings in a wall of said catheter to provide plural injectate ports for receiving fluid from said plural injectate lumens, respectively; and

locating said injectate ports from each other within the range of 15-20% of the distance between the first injectate port and the balloon to accommodate hearts of different sizes such that one of the injectate ports is proximal to the tricuspid valve in the right atrium for a relatively large heart and another of the injectate ports is proximal to the tricuspid valve in the right atrium for a relatively small heart.