BODILY FLUID SPACE ENTRY DETECTION

• US 20060167405A1
• Filed: 12/13/2004
• Published: 07/27/2006
• Est. Priority Date: 12/13/2004
• Status: Abandoned Application

• Current Assignee: Smiths Medical ASD, Inc. (Smiths Group International Holdings Ltd.)
• Original Assignee: Medex Incorporated (Smiths Group International Holdings Ltd.)
• Inventors: KING, Alan D, MUSKATELLO, James M
• Application Number:
  US10/905,047
• Publication Number:
  US 20060167405A1
• Time in Patent Office: Days
• US Class Current: 604/65
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150396 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/1535 comprising means for indicating vein or arterial entry A61B5/1545 takes precedence
• CPC Class Codes: A61M 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001
• CPC Class Codes: A61M 5/3286 Needle tip design, e.g. for improved penetration
• CPC Class Codes: A61M 5/329 characterised by features of the needle shaft

Abstract

A bodily fluid space entry detection system includes electrical contacts in non-conducting relationship and associated with a needle cannula. Entry of the distal, sharp tip of the cannula into a bodily fluid space such as a blood vessel or epidural space allows bodily fluid such as blood or spinal fluid to make a conduction path between the contacts which, in turn, causes an alert source to be energized to indicate entry into the bodily fluid space. The alert source could be an LED and/or a buzzer.

Claims

1. A bodily fluid space entry detection system comprising:

a cannula having a proximal end and a distal end, the distal end defining a sharp tip adapted to enter a bodily fluid space;

a pair of electrical contacts in non-conductive relationship associated with the cannula;

an electrically energizable alert source; and

an alert circuit in electrical communication with the pair of electrical contacts and adapted to cause the alert source to be electrically energized in response to bodily fluid establishing electrical conduction between the pair of electrical contacts whereby to provide an indication that the cannula tip is in a bodily fluid space.

2. The bodily fluid space entry detection system of claim 1 further comprising a first electrical conductor extending along a length of the cannula with a portion of the first electrical conductor exposed adjacent the cannula and defining one of the pair of electrical contacts.

3. The bodily fluid space entry detection system of claim 2, the exposed portion of the first electrical conductor being adjacent the cannula tip.

4. The bodily fluid space entry detection system of claim 2, the cannula including a groove on an exterior surface thereof, the first electrical conductor extending in the groove.

5. The bodily fluid space entry detection system of claim 2, the first electrical conductor extending within the cannula.

6. The bodily fluid space entry detection system of claim 5, the first electrical conductor including a conductive blunting member moveable within the cannula.

7. The bodily fluid space entry detection system of claim 6, further comprising an insulating coating on the conductive blunting member.

8. The bodily fluid space entry detection system of claim 2 further comprising a second electrical conductor extending along a length of the cannula with a portion of the second electrical conductor exposed adjacent the cannula and defining another of the pair of electrical contacts.

9. The bodily fluid space entry detection system of claim 8, the exposed portions of the first and second electrical conductors each being adjacent the cannula tip.

10. The bodily fluid space entry detection system of claim 8, one of the pair of electrical contacts being spaced further from the cannula tip then the other of the pair of electrical contacts.

11. The bodily fluid space entry detection system of claim 8, the conductors extending within the cannula.

12. The bodily fluid space entry detection system of claim 8, the electrical conductors being insulated from each other except at their respective exposed portions.

13. The bodily fluid space entry detection system of claim 2 wherein the cannula is conductive and defines another of the pair of electrical contacts.

14. The bodily fluid space entry detection system of claim 13, the first electrical conductor being insulated from the cannula except at a portion thereof.

15. The bodily fluid space entry detection system of claim 14, the portion being a distal end of the first electrical contact.

16. The bodily fluid space entry detection system of claim 14, the cannula including a groove on an exterior surface thereof, the first electrical conductor extending in the groove.

17. The bodily fluid space entry detection system of claim 13 further comprising a conductive blunting member moveable within the cannula.

18. The bodily fluid space entry detection system of claim 1, the alert source including an LED.

19. The bodily fluid space entry detection system of claim 18, the LED being red.

20. The bodily fluid space entry detection system of claim 18, the alert source further including a buzzer.

21. The bodily fluid space entry detection system of claim 1, the alert source including a buzzer.

22. The bodily fluid space entry detection system of claim 1 further comprising a battery.

23. The bodily fluid space entry detection system of claim 1, the alert source being positioned near the proximal end of the cannula.

24. The bodily fluid space entry detection system of claim 1, the alert circuit being positioned near the proximal end of the cannula.

25. The bodily fluid space entry detection system of claim 1 further comprising a housing containing the alert circuit and the alert source.

26. The bodily fluid space entry detection system of claim 25, the housing further containing a battery.

27. The bodily fluid space entry detection system of claim 26, the housing being removably connected to conductive elements electrically communicating with the electrical contacts.

28. The bodily fluid space entry detection system of claim 25, the housing being removably connected to conductive elements electrically communicating with the electrical contacts.

29. The bodily fluid space entry detection system of claim 1, further comprising a conductive blunting member moveable within the cannula.

30. The bodily fluid space entry detection system of claim 26, further comprising an insulating coating on the conductive blunting member.

31. The bodily fluid space entry detection system of claim 1 further comprising a third electrical contact associated with the cannula and being in non-conducting relationship with at least a first of the pair of electrical contacts, the alert circuit further being in electrical communication with the third electrical contact and adapted to cause the alert source to be electrically energized in response to bodily fluid establishing electrical conduction between the third and the at least first of the pair of electrical contacts.

32. The bodily fluid space entry detection system of claim 31 further comprising a conductive wire defining the third electrical contact and a second of the pair of the electrical contacts.

33. The bodily fluid space entry detection system of claim 1 further comprising at least a third electrical contact associated with the cannula and being in non-conducting relationship with both of the pair of electrical contacts, the alert circuit further being in electrical communication with the third electrical contact and adapted to cause the alert source to be electrically energized in response to bodily fluid establishing electrical conduction between the third electrical circuit and at least one of the pair of electrical contacts.

34. A catheter introducer device comprising:

a catheter hub and a catheter tube extending therefrom;

a cannula having a proximal end and a distal end, the distal end defining a sharp tip adapted to enter a bodily fluid space, the cannula extending through the catheter tube with the cannula tip projecting out therefrom;

a pair of electrical contacts in non-conductive relationship associated with cannula;

an electrically energizable alert source; and

an alert circuit in electrical communication with the pair of electrical contacts and adapted to cause the alert source to be electrically energized in response to body fluid establishing electrical conduction between the pair of electrical contacts whereby to provide an indication that the cannula tip is in a bodily fluid space.

35. The catheter introducer device of claim 34 further comprising a first electrical conductor extending along a length of the cannula with a portion of the first electrical conductor exposed adjacent the cannula and defining one of the pair of electrical contacts.

36. The catheter introducer device of claim 35, the exposed portion of the first electrical conductor being adjacent the cannula tip.

37. The catheter introducer device of claim 35, the cannula including a groove on an exterior surface thereof, the first electrical conductor extending in the groove.

38. The catheter introducer device of claim 35, the first electrical conductor extending within the cannula.

39. The catheter introducer device of claim 38, the first electrical conductor including a conductive blunting member moveable within the cannula.

40. The catheter introducer device of claim 39, further comprising an insulating coating on the conductive blunting member.

41. The catheter introducer device of claim 35 further comprising a second electrical conductor extending along a length of the cannula with a portion of the second electrical conductor exposed adjacent the cannula and defining another of the pair of electrical contacts.

42. The catheter introducer device of claim 41, the exposed portions of the first and second electrical conductors each being adjacent the cannula tip.

43. The catheter introducer device of claim 41, one of the pair of electrical contacts being spaced further from the cannula tip then the other of the pair of electrical contacts.

44. The catheter introducer device of claim 41, the conductors extending within the cannula.

45. The catheter introducer device of claim 41, the electrical conductors being insulated from each other except at their respective exposed portions.

46. The catheter introducer device of claim 35 wherein the cannula is conductive and defines another of the pair of electrical contacts.

47. The catheter introducer device of claim 46, the first electrical conductor being insulated from the cannula except at a portion thereof.

48. The catheter introducer device of claim 47, the portion being a distal end of the first electrical conductor.

49. The catheter introducer device of claim 47, the cannula including a groove on an exterior surface thereof, the first electrical conductor extending in the groove.

50. The catheter introducer device of claim 46, further comprising a conductive blunting member moveable within the cannula.

51. The catheter introducer device of claim 34, the alert source including an LED.

52. The catheter introducer device of claim 51, the LED being red.

53. The catheter introducer device of claim 51, the alert source further including a buzzer.

54. The catheter introducer device of claim 34, the alert source including a buzzer.

55. The catheter introducer device of claim 34 further comprising a battery.

56. The catheter introducer device of claim 34, the alert source being positioned near the catheter hub.

57. The catheter introducer device of claim 34, the alert circuit being positioned near the catheter hub.

58. The catheter introducer device of claim 34 further comprising a housing containing the alert circuit and the alert source.

59. The catheter introducer device of claim 58, the housing further including a battery.

60. The catheter introducer device of claim 59, the housing being removably mounted to the catheter hub.

61. The catheter introducer device of claim 59, the housing being removably connected to conductive elements electrically communicating with the electrical contacts.

62. The catheter introducer device of claim 61, one of the conductive elements communicating with one of the electrical contacts via the cannula.

63. The catheter introducer device of claim 61, one of the conductive elements communicating with one of the electrical contacts via a blunting member.

64. The catheter introducer device of claim 58, the housing being removably mounted to the catheter hub.

65. The catheter introducer device of claim 58, the housing being removably connected to conductive elements electrically communicating with the electrical contacts.

66. The catheter introducer device of claim 65, one of the conductive elements communicating with one of the electrical contacts via the cannula.

67. The catheter introducer device of claim 65, one of the conductive elements communicating with one of the electrical contacts via a blunting member.

68. The catheter introducer device of claim 34 further comprising a third electrical contact associated with the cannula and being in non-conducting relationship with at least a first of the pair of electrical contacts, the alert circuit further being in electrical communication with the third electrical contact and adapted to cause the alert source to be electrically energized in response to bodily fluid establishing electrical conduction between the third and the at least first of the pair of electrical contacts.

69. The catheter introducer device of claim 68 further comprising a conductive wire defining the third electrical and a second of the pair of electrical contacts.

70. The catheter introducer device of claim 34 further comprising at least a third electrical contact associated with the cannula and in non-conducting relationship with both of the pair of electrical contacts, the alert circuit further being in electrical communication with the third electrical contact and adapted to cause the alert source to be electrically energized in response to bodily fluid establishing electrical conduction between the third electrical circuit and at least one of the pair of electrical contacts.

71. A method of detecting entry of a cannula into a bodily fluid space comprising inserting a tip of a cannula into the bodily fluid space and energizing an alert source in response to body fluid in the bodily fluid space establishing electrical conduction along the cannula.

72. The method of claim 71 wherein energizing an alert source includes energizing an LED.

73. The method of claim 71 wherein energizing an alert source includes energizing a buzzer.

74. The method of claim 71 wherein the cannula extends through a catheter to be introduced into the bodily fluid space, the method further comprising withdrawing the cannula from the catheter after the alert source is energized.

75. The method of claim 71 wherein the alert source is coupled to an alert circuit and a battery all contained within a housing removably held adjacent an end of the cannula opposite the tip, the method further comprising removing the housing.

76. The method of claim 71 wherein the alert source is energized in response to the bodily fluid establishing electrical contact adjacent the cannula tip.

77. The method of claim 76 wherein the bodily fluid space is a blood vessel, the method further comprising inserting the cannula tip into the blood vessel and energizing the alert source in response to blood establishing the electrical conduction.

78. The method of claim 71, wherein the bodily fluid space is a blood vessel, the method further comprising inserting the cannula tip into the blood vessel and energizing the alert source in response to blood establishing the electrical conduction.

79. The method of claim 71 further comprising energizing the alert source in a modified manner in response to modified electrical conduction being established along the cannula by further flow of bodily fluid along the cannula.