Access needle pressure sensor device and method of use

• US 8,282,565 B2
• Filed: 03/12/2008
• Issued: 10/09/2012
• 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: Mahapatra, Srijoy, Gillies, George T.
• Primary Examiner(s): STIGELL, THEODORE J
• Application Number:
  US12/530,830
• Publication Number:
  US 20100094143A1
• Time in Patent Office: 1,672 Days
• Field of Search: 604 65- 67, 604/272, 604/246, 604/500, 604/506, 600/488, 600/561, 600/300, 600485-486, 606/185
• 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 and configured for sensing pressure in said one or more locations,

the pressure sensor in further communication with a processor configured to read sensed information from the pressure sensor to determine pressure frequencies and to be able to differentiate sensed information on a basis of different sensed pressure frequencies.

2. The device of claim 1, wherein the processor is configured to read sensed information from said one or more locations which 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, and the processor is configured to be able to differentiate between 0.2 Hz and 1.0 Hz.

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

6. The device of claim 1, further comprising an operator accessible reading system for reading the pressure frequency information from the pressure sensor, the reading system configured to interpret the pressure frequency information to identify whether the needle is in an appropriate or inappropriate location.

7. The device of claim 6, wherein the pressure frequency information is provided in real time while the needle is being advanced.

8. The device of claim 1, wherein the processor is configured to link with a display monitor and to provide information to be displayed as actual pressure readings from the pressure sensor or a time-derivative of the pressure readings from the pressure sensor.

9. The device of claim 8, wherein said information to be displayed is provided as a time-derivative of the pressure frequency readings from the pressure sensor.

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 medical element connection means.

13. The device of claim 11, further comprising multiple fluid flow channels in communication with said at least one proximal aperture.

14. The device of claim 13, wherein a connector is present along at least one of the multiple fluid flow channels and the connector comprises a stopcock.

15. The device of claim 14, wherein said 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 configured to 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 restoring force device, in communication with said puncture needle.

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

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

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

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

22. The device of claim 11, where said device is adapted to be visible on a medical imaging modality and the processor is configured with an algorithm to carry out signal analysis in near real time.

23. The device of claim 22, wherein said medical imaging modality comprises at least one of magnetic resonance imaging, computed tomography, and fluoroscopy.

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

25. The device of claim 24, further comprising multiple lumens configured between said plurality of distal apertures and plurality of said proximal apertures.

26. 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.

27. 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.

28. The device of claim 27, wherein said guideway provides coaxial alignment for said at least one of guide wire, sheath or catheter.

29. The device of claim 28, wherein said coaxial alignment is inside or outside said needle.

30. The device of claim 27, wherein said at least one guide wire, sheath, or catheter are coaxially aligned with one another.

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

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

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

inserting a needle having a pressure sensor associated with the needle, through the thorax and the middle mediastinum;

sensing pressure in said one or more locations; and

reading sensed information from the pressure sensor to determine pressure frequencies and differentiating sensed information on a basis of different sensed pressure frequencies.

34. The method of claim 33, wherein said sensing of pressure is provided by a pressure sensor attached to the needle.

35. The method of claim 33, wherein said one or more locations comprise the thorax and middle mediastinum.

36. The method of claim 33, wherein said one or more locations comprise an integral body part or space and an operator reading the pressure frequency information from the sensor and interpreting the pressure frequency information to identify whether the needle is in an appropriate or inappropriate location.

37. The method of claim 36, wherein said integral body part or space being located in the thorax.

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

39. The method of claim 38, wherein said organ comprises hollow organs, solid organs, parenchymal tissue, stromal tissue, and/or ducts.

40. The method of claim 33, where the one or more locations of the body comprises at least a portion of a tubular structure.

41. The method of claim 40, wherein said tubular structure comprises a blood vessel.

42. The method of claim 33, wherein said middle mediastinum includes the pericardial space.

43. The method of claim 33, further comprising inserting a guide wire into said needle.

44. The method of claim 43, further comprising placing a sheath on said guide wire or inside said needle.

45. The method of claim 43, further comprising placing a catheter on said guide wire or inside said needle.

46. The method of claim 33, further comprising puncturing tissue of the subject.

47. The method of claim 46, wherein said puncturing is provided by a puncture needle.

48. The method of claim 33, wherein said sensing of pressure comprises the indication of regions of positive pressure as well as those of negative pressure.

49. The method of claim 33, further comprising regulating infusion flow to be delivered through said needle.

50. The method of claim 33, further comprising imaging said needle with at least one of magnetic resonance imaging, computed tomography, fluoroscopy, or other radiological modalities.

51. The method of claim 33, further comprising providing readings from said sensing of pressure for navigating said needle that accesses the thorax and middle mediastinum.

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

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

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

a processor configured to read sensed information from the pressure sensor to determine pressure frequencies and to be able to differentiate sensed information on a basis of different sensed pressure frequencies.

53. The device of claim 52, wherein said elongated member is a needle or axial device.

54. The device of claim 52, wherein said one or more locations comprise the thorax and middle mediastinum.

55. The device of claim 52, wherein said one or more locations comprise an integral body part or space.

56. The device of claim 55, wherein said integral body part or space being located in the thorax.

57. The device of claim 52, wherein said one or more locations comprise at least a portion of an organ.

58. The device of claim 57, wherein said organ comprises hollow organs, solid organs, parenchymal tissue, stromal tissue, and/or ducts.

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

60. The device of claim 59, wherein said tubular structure comprises a blood vessel.

61. A method for sensing the pressure in one or more locations of a patient, said method comprising:

inserting an elongated member through the thorax and the middle mediastinum; and

sensing pressure frequencies in said one or more locations and differentiating a location of the needle as between the one or more locations by associating a specific sensed frequency with a particular location of the one or more locations.

62. The method of claim 61, wherein said sensing of pressure is provided by a pressure sensor.

63. The method of claim 61, wherein said elongated member is a needle or axial device.

64. The method of claim 61, wherein said one or more locations comprise the thorax and middle mediastinum.

65. The method of claim 61, wherein said one or more locations comprise an integral body part or space of the patient.

66. The method of claim 65, wherein said integral body part or space being located in the thorax.

67. The method of claim 61, wherein said one or more locations comprise at least a portion of an organ of the patient.

68. The method of claim 67, wherein said organ comprises hollow organs, solid organs, parenchymal tissue, stromal tissue, and/or ducts.

69. The method of claim 61, where the one or more locations of the body comprises at least a portion of a tubular structure of the patient.

70. The method of claim 69, wherein said tubular structure comprises a blood vessel.