Implantable intraosseous device for rapid vascular access

• US 5,868,711 A
• Filed: 12/05/1994
• Issued: 02/09/1999
• Est. Priority Date: 04/29/1991
• Status: Expired due to Term

• Current Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Original Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Inventors: Kramer, George C., Jenkinson, Joel P., Castaldo, Domenico N.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US08/349,371
• Time in Patent Office: 1,527 Days
• Field of Search: 604/49, 604/51, 604/137, 604/135, 604/180, 604/272, 604/174, 604/136, 606/185, 606/79
• US Class Current: 604/136
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/3247 Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/3291 Shafts with additional lateral openings
• CPC Class Codes: A61N 1/0575 with drug delivery

Abstract

A device and method for rapid access to the bone marrow for the infusion of drugs and other fluids into the bone marrow; sampling the bone marrow; and monitoring the physical properties of the blood and bone marrow. These operations may proceed sequentially or simultaneously. A "smart" controller may be utilized to direct or control these operations. An implantable intraosseous needle assembly and various means for injecting, utilizing, and extracting that assembly into a bone containing bone marrow are disclosed.

Claims

1. An intraosseous device, comprising:

an implantable intraosseous needle assembly for accessing a patient'"'"'s bone marrow; and

an injector having a nonrotationally produced axial driving force for rapidly and forcibly implanting the intraosseous needle assembly into an implantation site over a bone containing bone marrow, the injector being configured to house the intraosseous needle assembly prior to implantation and to be removed from the implantation site following implantation and before the intraosseous needle assembly is used to access the patient'"'"'s bone marrow.

2. The device of claim 1, wherein the intraosseous needle assembly comprises a tapered exterior surface.

3. The device of claim 1, wherein the intraosseous needle assembly comprises a fluted exterior surface.

4. The device of claim 1, wherein the intraosseous needle assembly has a means for connecting the needle assembly to peripheral devices.

5. The device of claim 1, wherein the intraosseous needle assembly has a medical tubing fitting.

6. The device of claim 1, wherein the intraosseous needle assembly has a high pressure fitting.

7. The device of claim 1, wherein the intraosseous needle assembly comprises a puncturing end, an interconnecting end opposite the puncturing end, and a removable protective cap, the cap being positioned over the interconnecting end.

8. The device of claim 7, wherein the intraosseous needle assembly further comprises a removable trocar for puncturing the bone.

9. The device of claim 8, wherein the trocar is connected to the protective cap.

10. The device of claim 9, wherein the removable trocar is housed within a cannula, said cannula extending between the puncturing end and the interconnecting end of the needle assembly.

11. The device of claim 10, wherein the cannula comprises at least two lumens.

12. The device of claim 1, wherein the intraosseous needle assembly comprises a removable trocar for puncturing the surface of the bone.

13. The device of claim 12, wherein the intraosseous needle assembly further comprises a cannula through which the removable trocar can be positioned for implantation and then removed to allow access to the bone marrow through the cannula.

14. The device of claim 1, wherein the injector comprises a piston configured to move in the axial direction without substantial rotation.

15. The device of claim 14, wherein the injector further comprises a cylinder that extends in the axial direction within which the piston is displaced to implant the needle assembly.

16. The device of claim 15, wherein the injector further comprises one or more safety interlocks.

17. The device of claim 16, wherein at least one of the one or more safety interlocks comprises a vent assembly.

18. The device of claim 17, wherein the vent assembly comprises a valve with a venting port and a pressurizing port.

19. The device of claim 18, wherein the venting port is configured to vent the cylinder unless the injector is properly aligned to implant the needle assembly, and the pressurizing port is configured to pressurize the cylinder when the injector is properly aligned to implant the needle assembly.

20. The device of claim 15, wherein the piston is pneumatically driven.

21. The device of claim 16, wherein at least one of the one or more safety interlocks comprises a latching means for inhibiting displacement of the piston.

22. The device of claim 14, wherein the piston is hydraulically driven.

23. The device of claim 14, wherein the piston is electromechanically driven.

24. The device of claim 14, wherein the piston is spring driven.

25. The device of claim 24, wherein the injector further comprises a single drug or fluid dose and a means for injecting said dose into the bone marrow during implantation of the intraosseous needle assembly.

26. The device of claim 14, wherein the injector further comprises a displacing means for moving the piston.

27. The device of claim 26, further comprising one or more safety interlocks, wherein at least one of the one or more safety interlocks comprises a blocking means for preventing the displacing means from acting upon the piston.

28. The device of claim 14, wherein the injector further comprises a handle for applying manual force to the piston.

29. The device of claim 14, wherein the piston comprises a hammerhead for receiving an axial implanting force from a hammer or mallet.

30. The device of claim 1, wherein the injector further comprises one or more safety interlocks.

31. The device of claim 30, wherein the injector further comprises an enabling switch operatively connected to at least one of the one or more safety interlocks.

32. The device of claim 30, wherein at least one of the one or more safety interlocks comprises an enabling spring cooperatively connected to the injector.

33. The device of claim 32, wherein the injector comprises a compressible member configured to allow compression of the enabling spring.

34. The device of claim 30, wherein at least one of the one or more safety interlocks comprises an hydraulic force venting assembly.

35. The device of claim 30, wherein at least one of the one or more safety interlocks comprises an electric switch.

36. The device of claim 1, wherein the intraosseous needle assembly further comprises an extendible puncturing tip.

37. The device of claim 36, wherein the extendible puncturing tip comprises a recessed infusion port covered by the extendible tip unless the tip is extended.

38. The device of claim 37, wherein the needle assembly comprises a means for extending and retracting the extendible tip.

39. The device of claim 1, wherein the injector and needle assembly comprise packaging containing equipment, drugs and fluid required for the treatment of specific emergency situations.

40. The device of claim 39, wherein the packaging comprises labeling indicating the particular emergency the packaged materials are intended to treat.

41. The device of claim 1, wherein the injector comprises:

a pressure chamber;

a piston;

a cylinder within which the piston is displaced in the axial direction during operation of the injector;

a channel which connects the pressure chamber to the cylinder;

a quantity of pressurized fluid contained within the pressure chamber;

a valve positioned between the pressure chamber and the cylinder; and

a firing mechanism located on the injector for operating the valve.

42. The device of claim 41, wherein the intraosseous needle assembly further comprises:

a tapered and fluted exterior surface;

a puncturing end and an interconnecting end opposite the puncturing end;

a medical fitting positioned at the interconnecting end;

at least one infusion port located near the puncturing end of the needle assembly;

a threaded, removable protective cap positioned between the injector and the medical fitting;

a trocar connected to the protective cap; and

threads positioned near the interconnecting end for securing the protective cap and trocar to the needle assembly.

43. The device of claim 1, wherein the intraosseous needle assembly further comprises:

a tapered and fluted exterior surface;

a medical fitting positioned at the interconnecting end;

at least one infusion port located near the puncturing end of the needle assembly;

a threaded, removable protective cap positioned between the injector and the medical fitting;

a trocar connected to the protective cap; and

threads positioned near the interconnecting end for securing the protective cap and trocar to the needle assembly.

44. The device of claim 1, wherein the injector comprises a carrier which comprises:

one or more guidance rings;

one or more spring-driven pins for triggering the injector; and

a means for removing the injector from the implantation site following implantation of the needle assembly.

45. A rapidly implantable intraosseous device, comprising an intraosseous needle assembly having an unthreaded puncturing end and an interconnecting end, wherein the interconnecting end further comprises a means for connecting the needle assembly to peripheral devices, and wherein the puncturing end of the needle assembly comprises at least one infusion port, and wherein the puncturing end further comprises a puncturing tip configured to penetrate the surface of a bone containing bone marrow without substantial rotation of the needle assembly.

46. An intraosseous device, comprising:

an implantable intraosseous needle assembly for accessing a patient'"'"'s bone marrow, the needle assembly having a puncturing end and an interconnecting end opposite the puncturing end; and

an injecting means for rapidly and forcibly implanting the intraosseous needle assembly in a bone containing bone marrow without substantial rotation of the needle assembly.

47. An intraosseous device, comprising:

an implantable intraosseous needle assembly for accessing a patient'"'"'s bone marrow having a puncturing end and an interconnecting end opposite the puncturing end;

an injector for rapidly and forcibly implanting the needle assembly through the application of a nonrotationally produced axial driving force; and

a receiver positioned over an implantation site, and configured such that the injector is positioned over the receiver prior to implantation, the needle assembly is guided into the patient'"'"'s bone marrow by the receiver during implantation, the injector is removed from the implantation site after implantation, and the receiver remains in place over the implantation site while the bone marrow is being accessed through the needle assembly.

48. The device of claim 47, wherein the receiver comprises a patient interface surface and an injector interface surface.

49. The device of claim 48, wherein the injector comprises a conical base, and the injector interface surface comprises a conical exterior surface configured to matingly receive the injector'"'"'s conical base.

50. The device of claim 48, wherein the patient interface surface further comprises a force absorbing means.

51. The device of claim 48, wherein the injector comprises one or more safety interlocks, at least one of the one or more safety interlocks being activated (i.e., positioned such that the injector can implant the needle assembly) when the injector is positioned over the receiver.

52. The device of claim 51, wherein the injector interface surface comprises one or more outwardly extending studs for operating at least one of the one or more safety interlocks.

53. The device of claim 47, wherein the receiver comprises a means for securing the receiver in place at the implantation site.

54. The device of claim 47, wherein the receiver further comprises one or more latches to secure the intraosseous needle assembly to the receiver after implantation.

55. The device of claim 47, wherein the receiver further comprises an intraosseous needle alignment channel.

56. An intraosseous device, comprising:

an implantable intraosseous needle assembly for accessing a patient'"'"'s bone marrow, and having a puncturing end and an interconnecting end opposite the puncturing end;

an injector for rapidly and forcibly implanting the needle assembly through the application of a nonrotationally produced axial driving force; and

a receiving means for receiving the injector and securing the needle assembly to an implantation site after implantation.

57. An intraosseous device, comprising:

an intraosseous needle assembly with a puncturing end and an interconnecting end opposite the puncturing end;

an injector for implanting the needle assembly in a patient, the injector configured to house the needle assembly prior to implantation;

a receiver positioned over an implantation site to receive the needle assembly and to secure the needle assembly to the patient; and

,

an intraosseous needle extractor for removing the needle assembly from the patient following use.

58. The device of claim 57, wherein the receiver comprises one or more latches for securing the intraosseous needle assembly and the extractor comprises one or more wedges for disengaging at least one of the one or more latches.

59. The device of claim 57, wherein the extractor comprises a shaft having threads for rotating the needle assembly during removal.

60. The device of claim 59, wherein the extractor has a threaded engager for connecting the extractor to the needle assembly.

61. The device of claim 60, wherein the engager'"'"'s threads are opposed to the extractor shaft threads.

62. The device of claim 57, wherein the receiver comprises at least one stud extending away from the implantation site, and the extractor comprises a groove for housing the at least one stud.

63. The device of claim 57, wherein the extractor has an engaging means for connecting the extractor to the needle assembly.

64. An intraosseous device, comprising:

an intraosseous needle assembly for accessing a patient'"'"'s bone marrow with a puncturing end and an interconnecting end opposite the puncturing end;

an injector for implanting the needle assembly, the injector configured to house the needle assembly prior to implantation;

a receiver positioned over an implantation site to receive the needle assembly and to secure the needle assembly to the patient; and

,

one or more sensors positioned in contact with the bone marrow through the needle assembly.

65. The device of claim 64, wherein at least one of the one or more sensors is connected to a central processing unit configured to analyze one or more properties of the bone marrow.

66. The device of claim 65, wherein the central processing unit comprises a visual display configured to display the output of at least one of the one or more sensors.

67. The device of claim 66, wherein the visual display is further configured to provide treatment information.

68. A method for monitoring blood and bone marrow properties, comprising:

providing an intraosseous needle assembly having a puncturing end and an interconnecting end, an injector, and a receiver;

loading the intraosseous needle assembly into the injector;

attaching the receiver to an implantation site;

aligning the injector with the receiver;

injecting the puncturing end of the needle assembly into a bone by operating the injector;

securing the needle assembly to the receiver;

inserting at least one sensor into the bone marrow via the intraosseous needle assembly; and

monitoring the output of the at least one sensor.

69. A method for accessing the bone marrow, comprising:

providing an intraosseous needle assembly having an unthreaded puncturing end and an interconnecting end, said puncturing end having at least one port; and

forcibly implanting the intraosseous needle assembly into a bone containing bone marrow by applying a nonrotationally produced axial driving force to the needle assembly.

70. An intraosseous device, comprising:

an implantable intraosseous needle assembly for accessing a patient'"'"'s bone marrow; and

an injector configured to implant the needle assembly into a bone containing bone marrow by applying a nonrotationally produced axial driving force to the needle assembly such that the needle assembly develops substantial momentum prior to contacting the bone.

71. The device of claim 70, wherein the injector produces momentum sufficient to cause the needle assembly to penetrate the surface of the bone.