Intraosseous device and methods for accessing bone marrow in the sternum and other target areas

• US 8,998,848 B2
• Filed: 01/08/2007
• Issued: 04/07/2015
• Est. Priority Date: 11/12/2004
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences II LLC
• Original Assignee: Vidacare LLC (Teleflex Incorporated)
• Inventors: Miller, Larry J., Titkemeyer, Robert W., Bolleter, David S., Trevino, Ruben, Harmon, Matthew T., Kilcoin, Christopher
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Thomas, Jr., Bradley G
• Application Number:
  US11/620,927
• Publication Number:
  US 20070270775A1
• Time in Patent Office: 3,011 Days
• Field of Search: 604/19, 604/48, 604/117, 604/506, 604/507, 604/187, 604/116, 604/181, 604/21, 606/80
• US Class Current: 604/117
• CPC Class Codes: A61B 10/025 for taking bone, bone marrow or cartilage samples
• CPC Class Codes: A61B 2010/0258 Marrow samples
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

Apparatus and methods are provided to access bone marrow at various target areas. Such apparatus may include an intraosseous device operable to penetrate bone at a selected target area and a depth limiter operable to control depth of penetration of the intraosseous device into bone and associated bone marrow. A manual driver and a guide may be included to optimize optimum insertion of the intraosseous device at a selected insertion site on a sternum.

Claims

1. Apparatus for accessing bone marrow of a sternum comprising:

a intraosseous device having a penetrator with a tip operable to penetrate the sternum;

a driver operable to insert a portion of the intraosseous device into the sternum, the driver having an exterior surface configured to be grasped by the user;

wherein the driver further comprises;

a handle having a first surface with a generally dome shaped configuration extending from the first surface;

the dome shaped portion ergonomically designed to fit the palm of an operator; and

a connector extending from the first surface of the handle; and

the connector operable to releasably engage the driver with the intraosseous device;

a guide operable to locate the driver and intraosseous device at an insertion site on the sternum;

the guide having an elongated cavity operable to receive a portion of the intraosseous device therein;

the elongated cavity in the guide defined in part by a first opening operable to receive the portion of the intraosseous device therethrough; and

the elongated cavity in the guide having a second opening sized to accommodate releasably engaging the driver with the intraosseous device and to accommodate inserting the intraosseous device into the sternum using the driver;

where the apparatus is configured such that the distance between the tip and the exterior surface of the driver will remain substantially constant during insertion of the intraosseous device into the sternum.

2. The apparatus of claim 1 further comprising a depth limiter operable to control depth of penetration of the intraosseous device into the sternum.

3. The apparatus of claim 1 wherein the driver further comprises a handle having a generally circular configuration.

4. The apparatus of claim 1 wherein the guide further comprises:

a first surface operable to be disposed on the sternum; and

a notch formed in one end of the first surface.

5. The apparatus of claim 1 wherein the depth control mechanism further comprises a collar disposed on an exterior portion of the intraosseous device.

6. The apparatus of claim 1 further comprising a depth control mechanism operable to limit depth of penetration of the intraosseous device into the sternum.

7. The apparatus of claim 6 wherein the depth control mechanism further comprises:

a collar having a generally elongated, hollow configuration;

the collar disposed on an exterior portion of the intraosseous device;

a plurality of longitudinal slots formed in the exterior of the collar;

a respective blade disposed in each slot; and

the blades operable to form incisions in skin, muscle and other soft tissue covering the desired injection site.

8. The apparatus of claim 7 further comprising portions of the intraosseous device, while being inserted into the sternum, operable to rotate relative to the collar.

9. The apparatus of claim 1, further comprising a plurality of finger grips formed in exterior portions of the handle.

10. Apparatus for accessing bone marrow proximate an insertion site comprising:

a driver operable to insert an intraosseous device into the bone marrow, the intraosseous device including at least a cannula;

the driver having a handle with an exterior surface configured to be grasped by the user and a connector extending from the handle, where the connector is configured to releasable secure the handle relative to the cannula;

the intraosseous device disposed in a kit prior to engagement with the driver;

the intraosseous device having a tip;

the driver and intraosseous device being configured such that distance between the tip and the exterior surface of the driver will remain substantially constant during insertion of the intraosseous device;

a scalpel disposed in the kit; and

the scalpel operable to form an incision in soft tissue covering the insertion site after removing the scalpel from the kit.

11. The apparatus of claim 10 further comprising:

the driver having a handle with a connector extending therefrom; and

the intraosseous device having a connector receptacle operable to be releasably engaged with the connector of the driver.

12. The apparatus of claim 10 further comprising:

a removable cover placed over the first recess and the second recess to retain the intraosseous device and the scalpel therein until the cover has been removed from the kit; and

the kit and the cover formed from disposable material.

13. The apparatus of claim 10 wherein the first recess further comprises:

a first container operable to receive the intraosseous device; and

a removable cover placed over the container to retain the intraosseous device in the first container.

14. The apparatus of claim 13 wherein the second recess further comprises:

a second container operable to receive at least a portion of the scalpel therein; and

the first container and the second container engaged with each other.

15. Apparatus for accessing bone marrow of a sternum comprising:

an intraosseous needle set configured to penetrate the sternum and provide access to the bone marrow of the sternum;

a driver operable to insert the IO needle set into the bone marrow of the sternum;

a guide mechanism operable to stabilize the intraosseous needle set during insertion into the bone marrow of the sternum;

the guide mechanism including a generally hollow, cylindrical portion operable to be inserted into an incision formed in soft tissue covering the sternum;

the generally hollow, cylindrical portion having an inside diameter operable to receive portions of the intraosseous needle set therein and to allow rotation of the intraosseous needle set during insertion relative to the generally hollow, cylindrical portion;

a generally disk shaped portion with the hollow, cylindrical portion extending therefrom and unitary with the generally disk shaped portion;

an opening formed in the disk shaped portion adjacent to and communicating with the elongated cylindrical portion; and

the opening formed in the disk having a generally coned shaped surface operable to guide one end of the intraosseous needle set therethrough.

16. The apparatus of claim 15 wherein the intraosseous needle set further comprises an outer cannula and an inner stylet.

17. The apparatus of claim 16 wherein the hollow, cylindrical portion comprises an elongated collar surrounding the cannula.

18. An intraosseous device operable to penetrate a bone and associated bone marrow comprising:

a hub having a first end operable to be releasably engaged with a connector and a second end operable to be disposed adjacent to an insertion site for the intraosseous device;

a first opening formed in the first end of the hub;

a first longitudinal bore extending from the first opening through the hub to a second opening formed in the second end of the hub;

an outer penetrator having a first end securely disposed within the longitudinal bore of the hub proximate the first opening in the hub;

the outer penetrator having a second end extending from the second opening of the hub;

a depth limiter having a first end engaged with the hub;

the depth limiter disposed around exterior portions of the outer penetrator extending from the second end of the hub; and

a second end of the depth limiter spaced a selected distance from a tip of the intraosseous device.

19. The apparatus of claim 18 further comprising:

a Luer lock connection formed on the first end of the hub; and

the Luer lock connection operable to accommodate attaching the first end of the hub to a fluid source.

20. The intraosseous device of claim 18 further comprising:

the first end of the hub formed on a first segment of the hub;

the first longitudinal bore extending through the first segment of the hub;

the second end of the hub formed on a second segment of the hub;

the second segment of the hub having a second longitudinal bore extending therethrough;

the first segment of the hub having exterior dimensions sized to fit within the second longitudinal bore of the second segment of the hub;

a first set of threads formed on exterior portions of the first segment of the hub;

a second set of threads form on interior portions of the second longitudinal bore;

the first portion of the hub threadably engaged with the second portion of the hub;

a first end of the outer penetrator disposed proximate the first end of the first portion of the hub; and

the first set of threads and to cooperate with the second set of threads operable to cooperate with each other to vary the distance between the second end of the depth limiter and the second surface of the hub.

21. The apparatus of claim 18 further comprising a removable inner penetrator disposed within the first longitudinal bore of the first portion of the hub.

22. Apparatus for accessing bone marrow in a sternum comprising:

a driver operable to insert an IO needle set into the bone marrow of the sternum;

the intraosseous needle set operable to penetrate the sternum and provide access to bone marrow of the sternum;

the intraosseous needle set including an outer cannula having a tip and an inner trocar;

a hub having a flange operable to stabilize the intraosseous needle set after inserting the intraosseous needle set into the bone marrow in the sternum where the hub is configured to be removably coupled to the driver; and

a collar extending from the hub to a distal end disposed between the flange and the tip, the collar disposed around and in non-adjustably fixed relation to the cannula such that the distal end of the collar is configured to limit depth of penetration of the intraosseous needle set into the bone marrow of the sternum;

where the apparatus is configured such that the distance between the distal end of the collar and the tip of the outer cannula will remain substantially constant during insertion of the intraosseous needle set into the sternum.

23. The apparatus of claim 22, further comprising:

the driver having a handle defined in part by a generally dome shaped portion;

the dome shaped portion extending from a surface having a generally circular configuration defined in part by a first diameter;

the intraosseous needle set having a connector defined in part by a first end having a generally circular configuration defined in part by a second diameter; and

the first diameter associated with the handle approximately equal to the second diameter associated with the first end of the connector.

24. Apparatus operable to direct and limit depth of penetration of an intraosseous device into bone marrow proximate an insertion site for the intraosseous device, comprising:

an elongated, hollow portion operable to be inserted into an incision formed in soft tissue covering the insertion site;

the elongated, hollow portion having a first end with an enlarged portion of the apparatus disposed adjacent thereto;

the elongated, hollow portion having a second end operable to engage portions of an anterior cortex proximate the insertion site without penetrating the anterior cortex; and

the enlarged portion of the apparatus operable to removably receive a needle set of the intraosseous device to limit movement of the intraosseous device through the elongated, hollow portion.

25. The apparatus of claim 24 wherein the enlarged portion further comprises:

a generally circular disk having a first surface and a second surface;

the elongated, hollow portion extending from the second surface of the disk opposite from the first surface;

the elongated, hollow portion having a longitudinal passageway extending therethrough;

an opening disposed in the disk;

the hole in the disk generally aligned with the longitudinal passageway of the elongated, hollow portion;

the opening and the longitudinal passageway sized to receive portions of the intraosseous device therein.

26. The apparatus of claim 25 further comprising the second surface of the disk operable to support portions of the intraosseous device thereon.

27. Apparatus operable to access bone marrow proximate an insertion site comprising:

an intraosseous device including an outer penetrator, an inner penetrator, and a connector securely engaged with a manual driver;

the manual driver operable to insert portions of the intraosseous device through an anterior cortex of a bone and into adjacent bone marrow;

the manual driver defined in part by a handle; and

the connector configured to releasably secure the handle and inner penetrator relative to the outer penetrator.

28. The apparatus of claim 27 further comprising:

the handle having a generally spherical portion extending from a generally planar surface; and

the generally planar surface of the handle securely engaged with the one end of the connector.

29. The apparatus of claim 28 further comprising the generally planar surface of the handle having a diameter approximately equal to a diameter of the one end of the connector.

30. The apparatus of claim 27 further comprising the manual driver formed as an integral component of the connector.