Thermodilution and pressure transducer balloon catheter

• US 4,878,898 A
• Filed: 09/16/1988
• Issued: 11/07/1989
• Est. Priority Date: 08/17/1987
• Status: Expired due to Fees

• Current Assignee: Nova Medical Specialties
• Original Assignee: Nova Medical Specialties
• Inventors: Skaggs, James L., Griffin, Joseph C.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US07/245,623
• Time in Patent Office: 417 Days
• Field of Search: 604/96, 604/53, 604/280, 604/101, 128/675, 128/642
• US Class Current: 604/96.01
• CPC Class Codes: A61B 2562/02 Details of sensors specially adapted for in-vivo measurements
• CPC Class Codes: A61B 2562/0261 Strain gauges
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/028 by thermo-dilution
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61M 2025/1065 having a balloon which is inversely attached to the shaft at the distal or proximal end
• 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 25/10 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 multi lumen balloon catheter suitable for pulmonary artery catheterization incorporating both pressure and temperature measurement functionalities by means of a forward facing transducer strain gauge device located axially of the inflated balloon for pressure measurement and means for sensing the temperature of the fluid surrounding the exterior of the catheter in use.

Claims

1. A multiple lumen balloon catheter for pulmonary artery catheterization procedures comprising:

a multiple lumen catheter body having a distal end portion and proximal end portions;

inflatable balloon means surrounding said distal end portion and including hollow elastic cylindrical sleeve means having inside and outside surfaces, said sleeve means adhesively affixed proximal to said distal end to said catheter body by the inside surface of said sleeve means and adhesively affixed adjacent to the distal end of said catheter body by the outside surface of said sleeve means which has been turned inwardly of the sleeve so as to be inside at least a portion of the inside surface of said sleeve means, and

transducer means containing housing means having a closed distal end and an open proximal end and capable of being received in fluid tight relationship at the distal end of one of said lumens and adhesively adhered therein, said housing means containing arranged therein a silicon strain gauge bridge within but not fixedly connected to said housing means having wire means electrically connected thereto said wire means communicating through said lumen to the proximal end portion of said catheter body;

a piezoelectric Silicon strain gauge means having a front face and a rear face, said rear face being distally contiguous to said strain gauge bridge but not affixed thereto and in electrical contact therewith so that changes in resistance in said piezoelectric strain gauge means can be electrically sensed through the wire means electrically connected to said strain gauge bridge and said wire means, such changes in resistance being proportion to the pressure exerted onto the front face of said transducer means;

force transmitting means closing the distal end of said housing and contiguous to the distal face of said strain gauge means said force transmitting means comprising metal diaphragm means normally in physical contact with said strain gauge means and a titanium diaphragm means located distally of said metal diaphragm means and contiguous thereto, covering said open distal end of said housing means and in fluid tight relationship therewith to form the distal face of said transducer housing means, whereby fluid pressure applied to the titanium diaphragm means transmits a force to said metal diaphragm and onto said strain gauge means to produce a change in resistance that is proportional to said applied force and detectable through the wire means electrically connected to said silicon strain gauge bridge; and

said transducer means being located axially of the circumference of said balloon means when said balloon means is inflated.

2. The multiple lumen catheter of claim 1 wherein said multiple lumen catheter further contains infusion means, said infusion means including another of said lumens, and an opening through said catheter body communicating with said lumen of said infusion means communicating with the outside of said catheter body at a first locus proximal to said distal tip and said lumen further provided to communicate with a source of infusion fluid at a second location proximal to said first locus.

3. The multiple lumen catheter of claim 1 wherein said multiple lumen catheter body further contains temperature sensing means said temperature sensing means including at least one additional lumen and an opening through said catheter body communicating with said lumens, and including thermistor means located at the opening to said lumen, said lumen of said temperature sensing means further provided to communicate with a source of infusion fluid at location proximal to said opening.

4. The multiple lumen catheter of claim 3 wherein said thermistor means is located adjacent to the outer periphery of said catheter body at a position distal to said locus of communication of said infusion means lumen with the outside of said catheter body.

5. The multiple lumen catheter of claim 2 wherein said catheter comprises at least four lumens.

6. The multiple lumen catheter of claims 3 wherein said catheter comprises at least five lumens.

7. A multiple lumen balloon catheter for pulmonary artery catheterization procedures comprising:

a multiple lumen catheter body having a distal end portion and a proximal portion;

inflatable balloon means surrounding said distal portion and including hollow elastic cylindrical sleeve means having inside and outside surfaces, said sleeve means adhesively affixed proximal to said distal end to said catheter body by the inside surface of said sleeve means and adhesively affixed adjacent to the distal end of said catheter body by the outside surface of said sleeve means which has been turned inwardly of the sleeve so as to be inside at least a portion of the inside surface of said sleeve means, and

transducer means received in the distal end portion of said catheter body and adhesively affixed thereto, said transducer means having a deformable distal face generally perpendicular to the longitudinal axis of said catheter body, said face being capable of being deflected in response to fluid pressure, said transducer means further including piezoelectric Silicon strain gauge means physically communicating with said deformable distal face in a manner so that said gauge means exhibits proportional changes in electrical resistance in response to movements of said deformable distal face caused by the pressure on said deformable distal face, said transducer means being located axially of said balloon means when said balloon means is inflated, and

infusion means including at least another of said lumens said infusion means being exposed to the outside of said catheter body proximal to said distal tip for introducing or receiving fluid therethrough, and

temperature sensing means in at least one lumen exposed to the outside of said catheter body between said exposed infusion lumen and said distal tip for measuring the temperature of the fluid external to said catheter body at the location of said temperature sensing means.