FOLDABLE SENSOR DEVICE AND METHOD OF USING SAME

• US 20080208023A1
• Filed: 02/27/2007
• Published: 08/28/2008
• Est. Priority Date: 02/27/2007
• Status: Active Grant

• Current Assignee: Nonin Medical Incorporated
• Original Assignee: Nonin Medical Incorporated
• Inventors: Rosendahl, Peter R., Gruvac, Vladimir
• Granted Patent: US 8,326,392 B2
• Time in Patent Office: Days
• US Class Current: 600/344
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/6824 Arm or wrist
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6838 Clamps or clips
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A physiologic sensor device configured to be placed on an appendage. The sensor device includes a foldable portion designed to be deformed around the tip of the appendage. In some embodiments the foldable portion is a soft compressible material. In other embodiments a stabilization component is provided to isolate sensing elements from external forces. Some embodiments also include a deformable frame that folds in response to a bending force as the sensing device is placed on the appendage. The deformable frame holds the sensor device in place until another bending force is applied. In other embodiments the frame and/or sensor elements are removable and disposable relative to other components of the sensor device.

Claims

1. A sensor device comprising:

a foldable member carrying one or more sensor elements;

a communications link configured to transmit data from said one or more sensor elements; and

a frame engaging said foldable member, together said frame and foldable member adapted to be deformed from an initial shape into a customized form providing said one or more sensor elements in a desired orientation relative to a tissue field, with said frame maintaining said foldable member in said customized form.

2. The sensor device of claim 1 further comprising:

a flexible cover material connected to the foldable member, said flexible cover material covering a skin surface engaging material.

3. The sensor device of claim 1 further comprising:

a stabilization component between a lead of said communications link and said one or more sensors elements.

4. The sensor device of claim 3 wherein the stabilization component comprises:

a first aperture through said foldable member and disposed between said one or more sensor elements and said lead.

5. The sensor device of claim 4 wherein the stabilization component further comprises:

a second aperture through said foldable member and disposed between said first aperture and said one ore more sensor elements; and

a bridge disposed between said first aperture and second aperture.

6. The sensor device of claim 3 wherein the stabilizing component comprises:

an elongated tail.

7. The sensor device of claim 6 wherein the tail is configured to wrap around a finger and forearm of a user.

8. The sensor device of claim 1 wherein said one or more sensor elements further comprises:

a light source; and

a light detector configured to receive light from said light source through said tissue field.

9. The sensor device of claim 1 wherein the foldable member is removable from said one or more sensor elements.

10. The sensor device of claim 1 wherein said communications link is a wired link to a remote site.

11. The sensor device of claim 1 wherein said communications link is a wireless link.

12. The sensor device of claim 1 wherein said foldable member further comprises:

a first material disposed on a bottom portion of the device; and

a second material disposed on a top portion of the device.

13. The sensor device of claim 12 wherein the first material is a compressible material.

14. The sensor device of claim 13 wherein the first material is a polyurethane foam.

15. The sensor device of claim 12 wherein the second material is denser than the first material.

16. The sensor device of claim 12 wherein said frame is disposed between the first material and second material.

17. The sensor device of claim 16 wherein said frame is separable and disposable from said foldable component.

18. The sensor device of claim 1 wherein said frame is of malleable material.

19. The sensor device of claim 1 wherein the foldable member has a plurality of apertures arranged to provide air circulation to said tissue field covered by said foldable component.

20. The sensor device of claim 1 further comprising:

an alignment aperture adapted to be engaged by an appendage tip prior to folding of said foldable member.

21. The sensor device of claim 20 wherein the aperture has a first radius and a second radius, the first radius and the second radius corresponding to radii of said appendage tip.

22. The sensor device of claim 1 wherein the foldable member further comprises:

a curved portion configured to interface with a bottom portion of an appendage and to allow movement of the appendage when the device is folded.

23. The sensor device of claim 22 wherein the curved portion define portions of a pair of winglets configured to fold around sides of the appendage.

24. The sensor device of claim 1 wherein a rear section of the foldable member further comprises a stabilization component.

25. The sensor device of claim 24 wherein the stabilization component comprises a first aperture, wherein an appendage is placed through the first aperture prior to folding the device.

26. The sensor device of claim 25 wherein the stabilization component further comprises:

a second aperture proximate to the first aperture;

a bridge disposed between the first and second aperture; and

wherein the appendage is inserted through the second aperture over the bridge and through the first aperture such that the appendage

27. The sensor device of claim 24 wherein the stabilization component comprises a wrapping tail, the wrapping tail having a length sufficient to wrap around a forearm.

28. A sensor device configured to be placed on an appendage of an animal, comprising:

a foldable member carrying one or more sensor elements; and

a pliant frame connected to said foldable member, said frame and foldable member being configured by a deforming force to conform to an appendage, said frame and foldable member positioning said one or more sensor elements proximate to a tissue field of said appendage, and said frame maintaining said foldable member in a deformed orientation upon release of the deforming force.

29. The sensor device of claim 28 wherein the foldable member comprises:

a first material;

a second material; and

wherein the first material and second material overlap such that when folded the first material engages a surface of said tissue field and the second material is generally disposed on an outside of the folded member.

30. The sensor device of claim 29 wherein the first material is a foam-type material.

31. The sensor device of claim 30 wherein the first material is a polyurethane foam.

32. The sensor device of claim 29 wherein the second material is comprised of a foam like material, the second material being denser than the first material.

33. The sensor device of claim 32 wherein the second material defines a protective layer for the sensor device.

34. The sensor device of claim 28 wherein said foldable member is separable from said frame.

35. The sensor device of claim 28 further comprising:

a communications link providing communication between said one or more sensors and a remote device.

36. The sensor device of claim 35 wherein the communications link includes a wired component.

37. The sensor device of claim 35 wherein the communication link includes a wireless component.

38. The sensor device of claim 28 wherein the foldable member further comprises:

an alignment aperture adapted to be engaged by a tip of said appendage prior to folding of said foldable member.

39. The sensor device of claim 38 wherein the aperture has a first radius and a second radius, the first radius and the second radius corresponding to radii of said appendage tip.

40. The sensor device of claim 28 wherein the foldable member further comprises:

a curved portion, said curved portion configured to interface with a bottom portion of the appendage and to allow movement of the appendage when the device is folded.

41. The sensor device of claim 40 wherein the curved portion comprises portions of two winglets, the winglets configured to fold around sides of the appendage.

42. The sensor device of claim 28 wherein a rear section of the foldable member further comprises a stabilization component.

43. The sensor device of claim 42 wherein the stabilization component comprises a first aperture, wherein the appendage is placed through the first aperture prior to folding the device.

44. The sensor device of claim 43 wherein the stabilization component further comprises:

a second aperture proximate to the first aperture;

a bridge disposed between the first and second aperture; and

wherein the appendage is inserted through the second aperture over the bridge and through the first aperture during application of said sensor device.

45. The sensor device of claim 42 wherein the stabilization component comprises a wrapping tail, the wrapping tail having a length sufficient to wrap around a forearm.

46. The sensor device of claim 28 wherein the sensor comprises:

a pair of light emitting diodes disposed on the foldable member;

a photodiode disposed on the foldable member; and

wherein the LED and the photodiode are arranged on foldable member such that when folded the LED and photodiode are on opposite sides of the appendage.

47. A method of attaching a foldable sensor device to an appendage comprising:

placing the sensor device at a portion of the appendage;

folding the sensor device over said appendage portion into a folded orientation; and

biasing the sensor device in the folded orientation so as to retain said appendage portion within said folded sensor device.

48. The method of claim 47 further comprising:

placing a portion of the appendage into an alignment aperture, said aperture being sized to correspond with a tip of the appendage.

49. The method of claim 48 further comprising:

providing stabilization of the sensor device using portions of said appendage for stabilization.

50. The method of claim 49 wherein providing stabilization comprises:

inserting the appendage through a first aperture in the sensor device.

51. The method of claim 50 further comprising:

inserting the appendage through a second aperture in the sensor device; and

placing the appendage over a bridge located between the first and second apertures.

52. The method of claim 47 wherein providing stabilization comprises:

wrapping a portion of the sensor device around the appendage.

53. The method of claim 52 wherein wrapping the portion of the sensor device, further comprises:

wrapping the portion around a forearm of a patient.

54. The method of claim 47 wherein said folding comprises:

bending a rigid deformable frame disposed in a portion of said sensor device.

55. The method of claim 54 wherein the frame is initially provided in a flat form prior to being folded before use.

56. A method of attaching a foldable sensor device to an appendage comprising:

bending a deformable sensor device over an appendage portion so as position optical sensor elements on either side of the appendage; and

biasing said sensor device in a bent position so as to retain said appendage portion within said sensor device.

57. The method of claim 56 further comprising:

placing a tip portion of the appendage into an alignment aperture of said sensor device.

58. The method of claim 56 further comprising:

isolating said optical sensor elements with a stabilization component, said stabilization component transferring an external force to the appendage away from the optical sensor elements.

59. The method of claim 58 wherein said isolating comprises:

inserting the appendage through a first aperture in the sensor device.

60. The method of claim 59 further comprising:

inserting the appendage through a second aperture in the sensor device; and

placing the appendage over a bridge located between the first and second apertures.

61. The method of claim 58 wherein said isolating comprises:

wrapping a tail portion of the sensor device around the appendage.

62. The method of claim 61 wherein wrapping the portion of the sensor device, further comprises:

wrapping the portion around a forearm of a patient.

63. The method of claim 56 wherein the frame is initially provided in a flat form prior to being folded before use.

64. The method of claim 62 wherein said biasing is performed by a malleable frame engaging foldable material in contact with said apendage.

65. A method of adapting an oximeter sensor to an appendage comprising:

bending a deformable sensor device over an appendage into a customized form so as conform portions of said sensor device to said appendage and position elements of a light sensor at a tissue field of the appendage; and

maintaining said sensor device in said customized form with a biasing element so as to retain said sensor device upon said appendage and said light sensor elements at the tissue field.

66. The method of claim 65 further comprising:

isolating said optical sensor elements with a stabilization component, said stabilization component transferring an external force to the appendage away from the optical sensor elements.

67. The method of claim 66 wherein said isolating comprises:

inserting the appendage through a first aperture in the sensor device.

68. The method of claim 67 further comprising:

inserting the appendage through a second aperture in the sensor device; and

placing the appendage over a bridge located between the first and second apertures.

69. The method of claim 65 wherein said isolation comprises:

wrapping a tail portion of the sensor device around the appendage.

70. The method of claim 65 wherein said biasing element is a deformable frame.

71. The method of claim 70 wherein said frame is enclosed within at least a portion of the sensor device.

72. An assembly comprising:

a plurality of preformed sensor devices each having a deformable body, optical sensor components and a communications link, each sensor device being customized prior to use by deformation of said body from a preformed shape into a form fit to a unique patient morphology, and each sensor having a frame for maintaining said sensor in said form during a sensor process.

73. The assembly of claim 72 wherein the sensors are provided in a preformed shape which is generally flat.

74. The assembly of claim 72 wherein the patient morphology is defined upon an appendage of the patient.

75. A method of customizing a sensor device to a unique user comprising:

applying a bending force to a preformed sensor device having a deformable body, optical sensor components and a communications link, said bending force causing the body to deform into a shape unique to an appendage of said user; and

biasing said deformable body in said unique shape upon removal of said bending force, said biasing relying at least in part on a frame deformed by said bending force.

76. The method of claim 75 wherein said applying a bending force results in a portion of said body being bent over a finger tip with winglet portions being bent around the finger tip.

77. A method of manufacturing a sensor device comprising:

attaching optical sensor elements to a flexible substrate, said substrate sized to conform to at least a portion of a patient appendage;

coupling said optical sensor elements to a communications link extending away from said substrate; and

connecting a deformable frame to the substrate, said frame being sized to maintain the substrate to said portion of the patient appendage.

78. The method of claim 77 wherein said connecting includes encompassing said frame within said substrate.

79. The method of claim 77 wherein said substrate includes multiple plies of material.

80. A sensor device comprising:

a foldable member carrying one or more sensor elements; and

deformable means connected to said foldable member, said deformable means and foldable member being reconfigured by a deforming force to conform to an appendage, said deformable means and foldable member positioning said one or more sensor elements proximate to a tissue field of said appendage, and said deformable means providing forces tending to maintain the foldable member in a deformed orientation upon release of said deforming force.

81. The sensor device of claim 80 wherein said deformable means includes a malleable frame adapted to be bent around a tip of the appendage.

82. The sensor device of claim 81 wherein a portion of the malleable frame is bent along a longitudinal axis of the appendage and another portion of the malleable frame is bent along an axis perpendicular to the longitudinal axis.