Apparatus and methods for the measurement of cardiac output

• US 9,289,141 B2
• Filed: 10/10/2008
• Issued: 03/22/2016
• Est. Priority Date: 10/12/2007
• Status: Active Grant

• Current Assignee: Ecom Med Inc., Micropen Technologies Corporation (Heico Corporation)
• Original Assignee: Ecom Med Inc., Micropen Technologies Corporation (Heico Corporation)
• Inventors: Lowery, Guy Russell, Grande, William J.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): So, Elizabeth K
• Application Number:
  US12/249,886
• Publication Number:
  US 20090227885A1
• Time in Patent Office: 2,720 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0215 Silver or silver chloride containing
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/0535 Impedance plethysmography for measuring blood flow A61B5/0295
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/285 Endotracheal, oesophageal or gastric probes
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: H05K 1/0284 Details of three-dimensional rigid printed circuit boards H05K1/119 takes precedence; shaping of the substrate H05K3/0014
• CPC Class Codes: H05K 1/117 Pads along the edge of rigid circuit boards, e.g. for pluggable connectors
• CPC Class Codes: H05K 1/141 One or more single auxiliary printed circuits mounted on a main printed circuit, e.g. modules, adapters H05K1/142 and H05K1/147 take precedence
• CPC Class Codes: H05K 1/147 at least one of the printed circuits being bent or folded, e.g. by using a flexible printed circuit H05K1/148 takes precedence
• CPC Class Codes: H05K 2201/0949 Pad close to a hole, not surrounding the hole
• CPC Class Codes: H05K 3/4069 for via connections in organic insulating substrates

Abstract

The current invention provides an endotracheal tube fabricated with an array of electrodes disposed on an inflatable cuff on the tube. The array of electrodes includes multiple sense electrodes and a current electrode. The array of electrodes on the inflatable cuff is applied using a positive displacement dispensing system, such as a MicroPen®. A ground electrode is disposed on the tube approximately midway between the inflatable cuff and the midpoint of the endotracheal tube. The endotracheal tube is partially inserted into a mammalian subject'"'"'s airway such that when the inflatable cuff is inflated, thereby fixing the tube in position, the array of electrodes is brought into close contact with the tracheal mucosa in relative proximity to the aorta. The endotracheal tube is useful in the measurement of cardiac parameters such as cardiac output.

Claims

1. A medical device comprising:

a tube having a proximal portion and a distal portion;

an inflatable cuff connected to the distal portion of said tube; and

a plurality of sense electrodes, each of said sense electrodes comprising,

an electrode patch joined to said inflatable cuff,

an electrode runner extending a length in a proximal-distal orientation from said electrode patch, along said inflatable cuff, and along said distal portion of said tube, said electrode runner being joined along the length to said inflatable cuff and said tube,

a polymeric underlayer applied on the inflatable cuff and the tube, the polymeric underlayer separating said electrode patch from said inflatable cuff and separating said electrode runner from said inflatable cuff and said tube, and

a polymeric overlayer applied over the length of said electronic runner and applied over a periphery of said electrode patch,

wherein said electrode runner, said polymeric underlayer, and said polymeric overlayer being in a sandwich format with said polymeric underlayer being on the bottom and closest to said tube, said polymeric overlayer being on the top and farthest from the tube, and said electrode runner being between said polymeric underlayer and said polymeric overlayer.

2. The medical device of claim 1, wherein a circumferential distance between adjacent electrode runners is greater at a region of the inflated inflatable cuff when a maximal outer diameter of the cuff is achieved than at a region where the inflatable cuff contacts the distal portion of the tube.

3. The medical device of claim 2, wherein the polymeric overlayer is applied to said periphery of the sense electrode patches and said electrode runners after application of said sense electrode patches and said electrode runners to the tube and cuff.

4. The medical device of claim 3, wherein the polymeric underlayer comprises a UV curable adhesive, the sense electrodes comprise an electrically conductive ink, and the polymeric overlayer comprises a UV curable adhesive.

5. The medical device of claim 1, further comprising a tubule for inflating the inflatable cuff.

6. The medical device of claim 1, wherein the polymeric underlayer is applied to the inflatable cuff and the tube prior to application of the sense electrodes.

7. The medical device of claim 1, wherein the plurality of sense electrodes comprises five sense electrodes and the combination of the five sense electrodes provides three orthogonal pairs of sense electrodes.

8. The medical device of claim 7, wherein the tube is an endotracheal tube.

9. The medical device of claim 1 further comprising a current electrode joined on the distal portion of the tube approximately equidistant from a distal end of the tube and the midpoint of the tube.

10. The medical device of claim 9, wherein the current electrode is at least one centimeter in length as measured along a proximal-distal dimension of the tube.

11. The medical device of claim 1, wherein the electrode patch and the electrode runner of the sense electrodes comprise electrically conductive particles suspended in a polymeric matrix material.

12. The medical device of claim 11, wherein the electrically conductive particles are selected from silver and gold.

13. The medical device of claim 1, wherein electrode runner comprises a substantially linear and rigid beam like structure on the inflatable cuff that remains substantially linear and rigid when the inflatable cuff is deflated.

14. The medical device of claim 1, wherein the electrode patch and the electrode runner of the sense electrodes are written as a trace on the tube and/or the inflatable cuff.