Access Needle Pressure Sensor Device and Method of Use

• US 20100094143A1
• Filed: 03/12/2008
• Published: 04/15/2010
• Est. Priority Date: 03/19/2007
• Status: Active Grant

• Current Assignee: University of Virginia
• Original Assignee: University of Virginia Patent Foundation (University of Virginia)
• Inventors: Gillies, George T., Mahapatra, Srijoy
• Granted Patent: US 8,282,565 B2
• Time in Patent Office: Days
• US Class Current: 600/486
• CPC Class Codes: A61B 17/34 Trocars; Puncturing needles pointed biopsy instruments A61B10/0233; devices for piercing the ear-lobes A44C7/001; seals or hemostasis valves A61M39/06
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61B 5/202 Assessing bladder functions, e.g. incontinence assessment
• CPC Class Codes: A61B 5/4887 Locating particular structures in or on the body
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives

Abstract

A tool and method of positioning and delivering medical devices and therapeutics within the pericardial space, as well as other body part or space. A needle is inserted into the chest through a sub-xiphoid puncture, and the pressure within the needle is monitored manometrically or otherwise sensed as the needle is advanced towards the pericardial space. By reading the pressure within the needle while it is advanced, the clinician is able to know that he or she is avoiding insertion of it into organs or spaces not intended to be the target location. In addition the retractable sharp edge allows the operator to access the space and cut tissue but do so safely by retracting the sharp edge.

Claims

1. A device for accessing one or more locations of a subject, said device comprising:

a needle having a distal end and a proximal end; and

a pressure sensor in communication with said needle for sensing pressure in said one or more locations.

2. The device of claim 1, wherein said one or more locations comprise the thorax and middle mediastinum.

3. The device of claim 2, wherein said middle mediastinum includes the pericardial space.

4. The device of claim 1, wherein said one or more locations comprise an integral body part or space.

5. The device of claim 4, wherein said integral body part or space being located in the thorax.

6. The device of claim 1, wherein said one or more locations comprise at least a portion of an organ.

7. The device of claim 6, wherein said organ comprises hollow organs, solid organs, parenchymal tissue, stromal tissue, and/or ducts.

8. The device of claim 1, where the one or more locations of the body comprises at least a portion of a tubular structure.

9. The device of claim 8, wherein said tubular structure comprises a blood vessel.

10. The device of claim 1, further comprising:

at least one proximal lumen in communication with said at least one distal aperture and said at least one proximal aperture.

11. The device of claim 1, further comprising:

at least one aperture located at said distal end of said needle; and

at least one aperture located at said proximal end of said needle.

12. The device of claim 11, wherein said at least one proximal aperture comprises a Luer fitting or some other suitable medical connection means.

13. The device of claim 11, further comprising a multi-channel connector in communication with said at least one proximal aperture.

14. The device of claim 13, wherein said multi-channel connector comprises a stopcock or other connector means.

15. The device of claim 13, wherein said multi-channel connector comprises a control means for regulating infusion or flow of agents or other medium to be delivered through said needle.

16. The device of claim 11, further comprising a guide wire that can be inserted through said at least one proximal aperture and withdrawn from said distal aperture.

17. The device of claim 11, further comprising a puncture needle coaxially aligned with said needle.

18. The device of claim 17, further comprising a spring or other restoring force device, in communication with said puncture needle.

19. The device of claim 11, wherein said distal aperture comprises a configuration having at least one of the following:

the Barker Needle, the Tuohy Needle, the Tuohy-Flowers Needle, The Hustead Needle, the Weiss Needle, the Special Sprotte Needle, the Crawford Needle, or other such medical devices, or any combination thereof.

20. The device of claim 11, wherein said pressure sensor comprises at least one of the following:

manometric, solid-state, optical in nature, or otherwise sensitive to hydrostatic and hydrodynamic pressures.

21. The device of claim 11, wherein said pressure sensor is able to indicate regions of positive pressure and those of negative pressure.

22. The device of claim 11, further comprising at least one marking or scale indicator located on said needle.

23. The device of claim 11, where said device is adapted to be visible on a medical imaging modality.

24. The device of claim 23, wherein said medical imaging modality comprises at least one of magnetic resonance imaging, computed tomography, fluoroscopy, or other radiological modalities.

25. The device of claim 11, further comprising a plurality of distal apertures.

26. The device of claim 25, further comprising multiple lumens configured between said plurality of distal apertures and plurality of said proximal apertures.

27. The device of claim 1, further comprising a control means in communication with said device for regulating infusion flow to be delivered through said needle.

28. The device of claim 1, wherein said pressure sensor provides pressure readings for navigating said needle that accesses said at least one or more locations.

29. The device of claim 28, wherein said one or more locations comprise the thorax and middle mediastinum.

30. The device of claim 29, wherein said middle mediastinum includes the pericardial space.

31. The device of claim 28, wherein said one or more locations comprise integral body part or space.

32. The device of claim 31, wherein said integral body part or space being located in the thorax.

33. The device of claim 28, wherein said one or more locations comprise at least a portion of an organ.

34. The device of claim 33, wherein said organ comprises hollow organs, solid organs, parenchymal tissue, stromal tissue, and/or ducts.

35. The device of claim 28, where the one or more locations of the body comprises at least a portion of a tubular structure.

36. The device of claim 35, wherein said tubular structure comprises a blood vessel.

37. The device of claim 1, wherein said needle provides a guideway for the positioning of at least one of a guide wire, a sheath or a catheter for use in medical procedures, or any combination thereof.

38. The device of claim 37, wherein said guideway provides coaxial alignment for said at least one of guide wire, sheath or catheter.

39. The device of claim 38, wherein said coaxial alignment is inside or outside said needle.

40. The device of claim 37, wherein said at least one guide wire, sheath, or catheter are coaxially aligned with one another.

41. The device of claim 1, wherein said accessing comprises an interventional procedure.

42. The device of claim 41, wherein said interventional procedure comprises insertion of said needle through the sub-xyphoid area of the patient.

43. The device of claim 1, wherein said accessing comprises a surgical procedure.

44. The device of claim 1, wherein said accessing comprises medical procedure whereby the subject is not intubated.

45. A method for accessing one or more locations of a patient, said method comprising:

inserting a needle through the thorax and the middle mediastinum; and

sensing pressure in said one or more locations.

46. The method of claim 45, wherein said sensing of pressure is provided by a pressure sensor.

47. The method of claim 45, wherein said one or more locations comprise the thorax and middle mediastinum.

48. The method of claim 45, wherein said one or more locations comprise an integral body part or space.

49. The method of claim 48, wherein said integral body part or space being located in the thorax.

50. The method of claim 45, wherein said one or more locations comprise at least a portion of an organ.

51. The method of claim 50, wherein said organ comprises hollow organs, solid organs, parenchymal tissue, stromal tissue, and/or ducts.

52. The method of claim 45, where the one or more locations of the body comprises at least a portion of a tubular structure.

53. The method of claim 52, wherein said tubular structure comprises a blood vessel.

54. The method of claim 45, wherein said middle mediastinum includes the pericardial space.

55. The method of claim 45, further comprising inserting a guide wire into said needle.

56. The method of claim 55, further comprising placing a sheath on said guide wire or inside said needle.

57. The method of claim 55, further comprising placing a catheter on said guide wire or inside said needle.

58. The method of claim 45, further comprising puncturing tissue of the subject.

59. The method of claim 58, wherein said puncturing is provided by a puncture needle.

60. The method of claim 45, wherein said sensing of pressure comprises the indication of regions of positive pressure as well as those of negative pressure.

61. The method of claim 45, further comprising regulating infusion flow to be delivered through said needle.

62. The method of claim 45, further comprising imaging said needle with at least one of magnetic resonance imaging, computed tomography, fluoroscopy, or other radiological modalities.

63. The method of claim 45, further comprising providing readings from said sensing of pressure for navigating said needle that accesses the thorax and middle mediastinum.

64. A device for sensing the pressure in one or more locations of a subject, said device comprising:

an elongated member and having a distal end and a proximal end; and

a pressure sensor in communication with said elongated member for sensing pressure in said one or more locations.

65. The device of claim 64, wherein said elongated member is a needle or axial device.

66. The device of claim 64, wherein said one or more locations comprise the thorax and middle mediastinum.

67. The device of claim 64, wherein said one or more locations comprise an integral body part or space.

68. The device of claim 67, wherein said integral body part or space being located in the thorax.

69. The device of claim 64, wherein said one or more locations comprise at least a portion of an organ.

70. The device of claim 69, wherein said organ comprises hollow organs, solid organs, parenchymal tissue, stromal tissue, and/or ducts.

71. The device of claim 64, where the one or more locations of the body comprises at least a portion of a tubular structure.

72. The device of claim 71, wherein said tubular structure comprises a blood vessel.

73. A method for accessing one or more locations of a patient, said method comprising:

inserting a needle through the thorax and the middle mediastinum; and

sensing pressure in said one or more locations.