Brain retraction sensor

• US 7,153,279 B2
• Filed: 12/21/2004
• Issued: 12/26/2006
• Est. Priority Date: 07/09/2002
• Status: Expired due to Term

• Current Assignee: Michael Ayad
• Original Assignee: George Washington University
• Inventors: Ayad, Michael
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US11/016,818
• Publication Number:
  US 20050228315A1
• Time in Patent Office: 735 Days
• Field of Search: 600/587, 600/547, 600/372, 600/300, 600/544, 600/504, 600/202, 600/206, 600/207, 600/229, 600/473, 606/1
• US Class Current: 600/587
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/293 Invasive
• CPC Class Codes: A61B 5/4076 Diagnosing or monitoring particular conditions of the nervous system A61B5/4821, A61B5/4824 take precedence

Abstract

An electrode device is disclosed comprising a deformable envelope, further comprising recording electrodes and a pressure recording port. The device allows for monitoring of brain retraction pressure and local cortical electrical activity including DC potential, as well as redistribution of the force applied during retraction and cushioning of the rigid edges of the brain retractor, thereby diminishing the chance of focal brain injury during surgery. Retraction pressure recorded is equal over the full area of contact. A means is disclosed for optional evacuation of air from the system to improve accuracy and fidelity of the pressure measurements. Local brain hypothermia may be induced via the bladder and attached catheter, thereby providing additional neuroprotection during brain retraction. The device also allows for measurement of intracranial pressure, DC potential, EEG and, optionally, other physiologic parameters in epileptic and severe head trauma patients for management of edema and injury.

Claims

1. A brain retractor device comprising:

a first end comprising a substantially inextensible first cavity, wherein said first end is integral with a retractor blade;

a plurality of electrodes exposed along a first surface of said first end;

a first electric conduit;

a second conduit, which said second conduit allows for measuring pressure; and

a second end comprising an exit port, which exit port engages said first and second conduit.

2. The device of claim 1, wherein said electrodes are polarizable or non-polarizable.

3. The device of claim 2, wherein said electrodes are non-polarizable.

4. The device of claim 3, further wherein a distal end of said first electric conduit and one end of a remote reference electrode electrically connect to a differential DC amplifier.

5. The device of claim 1, wherein said second conduit is hydraulic.

6. The device of claim 1, wherein said retractor blade comprises a first aperture, which first aperture allows said first and second conduits to traverse opposing blade surfaces.

7. The device of claim 1, wherein said first end comprises substantially flat, smooth atraumatic faces.

8. The device of claim 1, wherein said first end comprises a thin, elastically deformable, bio-compatible material.

9. The device of claim 8, wherein the bio-compatible material is selected from silicone-based materials, thermoplastic elastomer, low density polyethylene or polyurethane.

10. The device of claim 1, wherein the exposed outer surface of the first cavity extends beyond the edges of the retractor blade.

11. The device of claim 10, wherein the extended surface does not obscure the operative field.

12. The device of claim 10, wherein said first cavity comprises a bladder or a network of interconnected lumens internal to the exposed surface.

13. The device of claim 1, wherein said device is able to operate whether the first cavity is filled with a gas or a liquid.

14. The device of claim 13, wherein the first cavity is filled with a gas.

15. The device of claim 13, wherein the first cavity is filled with a liquid.

16. The device of claim 15, wherein the liquid is selected from normal saline, buffered salt solution, Ringer'"'"'s solution, Elliot'"'"'s B solution, or mock cerebrospinal fluid.

17. The device of claim 1, wherein the cavity comprises a heat exchange fluid for induction of local brain hypothermia for the purpose of neuroprotection.

18. The device of claim 17, wherein said fluid is cooled by extracorporeal refrigeration.

19. The device of claim 18, wherein the fluid is cooled to a temperature of between about 0°

C. to about 10°

C.

20. The device of claim 17, wherein the heat exchange fluid is selected from saline, lactated Ringer'"'"'s solution, water, Elliot'"'"'s B solution or mock cerebrospinal fluid.

21. The device of claim 1, wherein said electric conduit further comprises a first tail distal to said first end, wherein said tail allows for communication between the device and at least one peripheral apparatus.

22. The device of claim 21, wherein the peripheral device comprises at least one adjunctive monitoring modality.

23. The device of claim 22, wherein said modality measures physiological parameters selected from brain compliance or elastance, cerebral impedance, fluid flow, partial pressure of oxygen or carbon dioxide, temperature, pH, metabolites or a combination thereof.

24. The device of claim 23, wherein said fluid flow is blood flow.

25. The device of claim 23, wherein said metabolites are selected from extracellular potassium or glutamate.

26. The device of claim 1, wherein said second conduit comprises a flexible, noncompliant material.

27. The device of claim 26, wherein said second conduit comprises at least one luminal surface.

28. The device of claim 27, wherein said second conduit comprises a double lumen catheter.

29. The device of claim 28, wherein one end of each separate luminal surface comprising said double lumen catheter engages separate fluid-flow directing connectors.

30. The device of claim 29, wherein said fluid-flow connectors are female luer-lock connectors.

31. The device of claim 1, wherein said first cavity can accommodate pressures of between about one mm Hg and about 120 mm Hg.

32. The device of claim 1, wherein the refractor blade comprises a substantially polygonal shape.

33. The device of claim 32, wherein the polygonal shape is substantially quadrilateral, further comprising rounded edges at straight-line boundaries.

34. The device of claim 32, wherein the retractor blade is tapered or blunt.

35. The device of claim 1, wherein said device is a brain retractor sensor (BRS).

36. A sub-dural device comprising:

a first end comprising a substantially inextensible cavity;

a plurality of electrodes exposed along a first surface of said first end;

a first electric conduit;

a second conduit, which said second conduit allows for measuring pressure; and

a second end comprising an exit port, which exit port engages said first and second conduit,

wherein said device is able to operate whether the cavity is filled with a gas or a liquid.

37. The device of claim 36, wherein said electrodes are polarizable or non-polarizable.

38. The device of claim 37, wherein said electrodes are non-polarizable.

39. The device of claim 38, further wherein a distal end of said first electric conduit and one end of a remote reference electrode electrically connect to a differential DC amplifier.

40. The device of claim 36, wherein said second conduit is hydraulic.

41. The device of claim 36, wherein said first end comprises substantially flat, smooth atraumatic faces.

42. The device of claim 36, wherein said first end comprises a thin, elastically deformable, bio-compatible material.

43. The device of claim 42, wherein the bio-compatible material is selected from silicone-based materials, thermoplastic elastomer, low density polyethylene or polyurethane.

44. The device of claim 43, wherein said cavity comprises a bladder or a network of interconnected lumens internal to the exposed surface.

45. The device of claim 36, wherein the cavity is filled with a gas.

46. The device of claim 36, wherein the cavity is filled with a liquid.

47. The device of claim 46, wherein the liquid is selected from normal saline, buffered salt solution, Ringer'"'"'s solution, Elliot'"'"'s B solution or mock cerebrospinal fluid.

48. The device of claim 36, wherein the cavity comprises a heat exchange fluid for induction of local brain hypothermia for the purpose of neuroprotection.

49. The device of claim 48, wherein said fluid is cooled by extracorporeal refrigeration.

50. The device of claim 49, wherein the fluid is cooled to a temperature of between about 0°

C. to about 10°

C.

51. The device of claim 50, wherein the heat exchange fluid is selected from saline, lactated Ringer'"'"'s solution, water, Elliot'"'"'s B solution or mock cerebrospinal fluid.

52. The device of claim 36, wherein said first electric conduit further comprises a first tail distal to said first end, wherein said tail allows for communication between the device and at least one peripheral apparatus.

53. The device of claim 52, wherein the peripheral device comprises at least one adjunctive monitoring modality.

54. The device of claim 53, wherein said modality measures physiological parameters selected from brain compliance or elastance, cerebral impedance, fluid flow, partial pressure of oxygen or carbon dioxide, temperature, pH, metabolites or a combination thereof.

55. The device of claim 54, wherein said fluid flow is blood flow.

56. The device of claim 54, wherein said metabolites are selected from extracellular potassium or glutamate.

57. The device of claim 36, wherein said second conduit comprises a flexible, noncompliant material.

58. The device of claim 57, wherein said second conduit comprises at least one luminal surface.

59. The device of claim 58, wherein said second conduit comprises a double lumen catheter.

60. The device of claim 59, wherein one end of each separate luminal surface comprising said double lumen catheter engages separate fluid-flow directing connectors.

61. The device of claim 60, wherein said fluid-flow connectors are female luer-lock connectors.

62. The device of claim 36, wherein said cavity can accommodate pressures of between about one mm Hg and about 120 mm Hg.