Universal electrocardiogram sensor positioning mask with repositionable sensors and method for employing same

• US 20030130585A1
• Filed: 01/09/2002
• Published: 07/10/2003
• Est. Priority Date: 01/09/2002
• Status: Active Grant

• Current Assignee: Unilead International Incorporated
• Original Assignee: Unilead International Incorporated
• Inventors: Wenger, William K.
• Granted Patent: US 6,751,493 B2
• Time in Patent Office: Days
• US Class Current: 600/509
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• CPC Class Codes: A61B 5/6841 by using templates

Abstract

A universal disposable ECG sensor positioning device and method for use with electrocardiogram diagnostic equipment in which the mask has six sensors, two of which are movable, to provide four different sizes to accommodate varying sized human torsos.

Claims

22. A method for obtaining electrocardiograms by means of a universal ECG multiple sensor dermal precordial mask incorporating sensors V₁, V₂, V₃, V₄, V₅, and V₆ for fitting different sizes of human bodies including extra large, said method comprising the steps of

providing a mask having at least ten precordial sensor positions disposed in a specific geometric arrangement and forming at least four sets of sensor groups including four alternate sensor positions for each of said V₅ and V₆ sensors,

said V₁-V₄ sensor positions being utilized for all sizes of bodies and said V₅ and V₆ positions, each having two independent sensor positions and sharing two positions corresponding to said four sensor sets,

said V₅ and V₆ sensors being releasably secured to said mask as detachable sensors with detachable variable length and flexible leads formed integral thereto whereby said V₅ and V₆ sensors are repositionable to each of said respective V₅ and V₆ alternate sensor positions, and

said mask including indicia for determining which alternate V₅ and V₆ sensor positions correspond to said four sensor sets,

aligning said mask on a patient'"'"'s chest so that said V₁ and V₂ are disposed approximately on opposite sides of the patient'"'"'s sternum,

ascertaining from said indicia which of said four V₆ sensor positions lies on or is closest to the patient'"'"'s midaxillary line,

detaching if necessary said releasably secured V₅ and V₆ sensors and then repositioning them onto the corresponding sensor positions of said set of positions on said mask which includes said V₆ sensor position lying closest to the patient'"'"'s midaxillary line, and

obtaining electrocardiographic information from said fixed position V₁-V₄ sensors and said movable V₅ and V₆ sensors.

23. The method of claim 22 wherein said repositionable sensors and leads are initially disposed at the sensor positions for one of the said four sets of sensor positions.

24. The method of claim 22 wherein said alternate V₅ and V₆ sensor positions are disposed along a horizontal line.

25. The method of claim 22 wherein said alternate V₅ and V₆ sensor positions on said mask are comprised of holes therein through which the movable sensor leads can be secured to the patient'"'"'s skin.

26. A method of sensor placement for performing twelve lead electrocardiograms by means of a universal ECG multiple sensor dermal chest mask formed for fitting or accommodating different sizes of adult human bodies including extra large with repeatability and clinical efficacy of sensors V₁, V₂, V₃, V₄, V₅, and V₆ placement irrespective of the varying human body torso sizes and the different distances between the human body anatomical landmarks, said method of sensor placement comprising the steps of

providing a mask having at least ten precordial sensor positions disposed in a specific geometric arrangement rather than in predetermined fixed arrays of individual sensor groups or an arbitrary individually located array of six precordial sensors needed for a resting ECG, said arrangement of ten sensor positions forming four sets of sensor groups including four alternative sensor positions for each of said V₅ and V₆ in which two sensor positions serve for either V₅ or V₆ in four different sensor sets whereby four sets of six sensor positions each are provided by said ten sensor positions to position six of said sensors proximate to the anatomical landmarks of four different classes of sizes of human torsos, said mask including first indicia for positioning said mask on a patient'"'"'s sternum centerline and the fourth intercostal space and second indicia for determining which sensor positions correspond to said four sensor sets,

providing six sensors for said ten sensor positions wherein four of said sensors and the leads therefor are positioned at said V₁-V₄ sensor positions and two sensors and leads therefor are releasably secured to said mask for subsequent repositioning onto two of said four respective alternative V₅ and V₆ sensor positions,

placing said mask on a patient'"'"'s chest and aligning said first positioning indicia on said mask with said patient'"'"'s corresponding anatomy,

ascertaining from said second indicia which of the four V₆ sensor positions lies on or closest to the patient'"'"'s midaxillary line,

repositioning said two sensors and the leads therefor if necessary onto the corresponding V₅ and V₆ sensor positions in said set of sensor positions which includes said V₆ sensor position lying closest to the patient'"'"'s midaxillary line, and

connecting ECG test apparatus to said sensor lead wires from said six sensors.

27. A universal ECG multiple sensor dermal precordial mask for fitting different sizes of human bodies including extra large for obtaining electrocardiographic information using sensors V₁, V₂, V₃, V₄, V₅, and V₆, said mask comprising

a sheet of non-conductive material incorporating at least six sensors and ten sensor positions disposed in a specific geometric arrangement with said V₁-V₄ sensors being utilized for all sizes of bodies, said ten sensor positions including four alternate positions for each V₅ and V₆ positions, said V₅ and V₆ sensors having first and second independent sensor positions each and first and second shared positions and being detachably secured to said sheet and repositionable and resecurable to any of the four separate sensor positions for each of V₅ and V₆.

28. A universal ECG multiple sensor dermal precordial mask for fitting different sizes of human bodies including extra large for obtaining electrocardiographic information using sensors V₁, V₂, V₃, V₄, V₅, and V₆, said mask comprising

a flexible sheet of non-conductive material incorporating at least ten sensor positions disposed in a specific geometric arrangement forming four sets of sensor groups including four alternate positions for each V₅ and V₆ position disposed along a horizontal line and including first and second independent sensor positions each and first and second shared positions, said V₁-V₄ positions including fixed sensors utilized for all sizes of bodies, and said V₅ and V₆ sensors being detachably secured to said sheet and repositionable and attachable to a patient'"'"'s skin through holes in said mask and at any of the four separate sensor positions for each of V₅ and V₆.

29. A mask as set forth in claim 28, wherein

when said mask is utilized for a small size torso, said repositionable V₅ sensor is secured at said first independent V₅ sensor position disposed closest to said V₄ position and said repositionable V₆ sensor is secured at said first shared V₅ and V₆ position which is also disposed closest to said V₄ position,

when said mask is utilized for a medium size torso, said repositionable V₅ sensor is secured at said second independent V₅ sensor position, disposed furthest from said V₄ position, and said repositionable V₆ sensor is secured at said second shared V₅ and V₆ position which is also disposed furthest from said V₄ position,

when said mask is utilized for a large size torso, said repositionable V₅ sensor is secured at said first shared V₅ and V₆ sensor position and said repositionable V₆ sensor is secured at first independent V₆ position disposed closest to said V₄ sensor position, and

when said mask is utilized for an extra large size torso, said repositionable V₅ sensor is secured at said second shared V₅ and V₆ sensor position and said repositionable V₆ sensor is secured at said second independent V₆ sensor position which is disposed furthest from said V₄ position.

30. The mask as set forth in claim 28 wherein

said V₁ and V₂ sensor positions are disposed equidistant from the patient'"'"'s sternum and on the fourth intercostal space, the center of said V₁ position is located approximately 2.0 inches from the center of said V₂ position on the 270 degree radial therefrom,

the center of said V₄ position is located approximately 3.5 inches from the center of said V₂ position on the 125 degree radial therefrom,

the center of said V₃ position is disposed on a line and equidistant between said V₂ and said V₄ positions, and

said V₅ and V₆ positions have four alternative positions each, all of said positions being disposed on a 90 degree radial from said V₄ position, the centers of said V₅ positions being located 1.75, 2.5, 3.5, and 5.0 inches therefrom and the centers of said V₆ positions being located 3.5, 5.0, 7.0, and 10.0 inches therefrom whereby the centers of said V₅ and V₆ positions which are both located 3.5 and 5.0 inches from said V₄ position share a common position in the different sets of sensors.

31. A disposable universal ECG multiple sensor dermal chest mask for fitting or accommodating different sizes of adult human bodies including extra large for performing twelve lead electrocardiograms with repeatability and clinical efficacy of sensor V₁, V₂, V₃, V₄, V₅, and V₆ placement irrespective of the varying human body torso sizes and the different distances between the human body anatomical landmarks, said mask comprising

a flexible sheet of non-conductive material having ten sensor positions disposed in a single pattern rather than in predetermined fixed arrays of individual sensor groups or an arbitrary individually located array of six precordial sensors which are needed for a resting twelve-lead ECG, said sensor positions disposed on said sheet in a specific geometric arrangement, said V₁-V₄ sensor positions including sensors which are utilized for all sizes of bodies, and said V₅ and V₆ sensor positions each having four alternate positions including first and second independent sensor positions each and first and second shared positions, said V₅ and V₆ sensors being detachably secured to said sheet and repositionable and attachable to a patient'"'"'s skin through holes in said mask at any of the four separate sensor positions for each of V₅ and V₆,

said V₁ and V₂ sensor positions being disposed to lie on opposite sides of a patient'"'"'s sternum equidistant therefrom and on the fourth intercostal space, the center of said V₁ position being located approximately 2.0 inches from the center of said V₂ position on the 270 degree radial therefrom,

the center of said V₄ position being located approximately 3.5 inches from the center of said V₂ position on the 125 degree radial therefrom,

the center of said V₃ position being disposed on a line and equidistant between said V₂ and said V₄ positions, and

said V₅ and V₆ sensors having four alternative positions each, all of said positions being disposed on a 90 degree radial from said V₄ position, the centers of said V₅ positions being located 1.75, 2.5, 3.5, and 5.0 inches therefrom and the centers of said V₆ positions being located 3.5, 5.0, 7.0, and 10.0 inches therefrom whereby the centers of said V₅ and V₆ positions which are both located 3.5 and 5.0 inches from said V₄ position share a common position in the different sets of sensors, whereby

when said mask is utilized for a small size torso, said repositionable V₅ sensor is secured at said first independent V₅ sensor position disposed closest to said V₄ sensor position and said repositionable V₆ sensor is secured at said first shared V₅ and V₆ sensor position which is also disposed closest to said V₄ position,

when said mask is utilized for a medium size torso, said repositionable V₅ sensor is secured at said second independent V₅ sensor position disposed furthest from said V₄ sensor position and said repositionable V₆ sensor is secured at said second shared V₅ and V₆ sensor position which is also disposed furthest from said V₄ position,

when said mask is utilized for a large size torso, said repositionable V₅ sensor is secured at said first shared V₅ and V₆ sensor position and said repositionable V₆ sensor is secured at said first independent V₆ sensor position which is disposed closest to said V₄ sensor position, and

when said mask is utilized for an extra large size torso, said repositionable V₅ sensor is secured at said second shared V₅ and V₆ sensor position and said repositionable V₆ sensor is secured at said second independent V₆ sensor position which is disposed furthest from said V₄ sensor position.