System and methods for injecting flowable materials into bones

• US 6,719,761 B1
• Filed: 02/02/2000
• Issued: 04/13/2004
• Est. Priority Date: 08/13/1997
• Status: Expired due to Term

• Current Assignee: Orthophoenix, LLC (Marathon Patent Group, Inc.)
• Original Assignee: Kyphon Incorporated (Medtronic Plc)
• Inventors: Reiley, Mark A, Scholten, Arie, Scribner, Robert M, Reo, Michael L
• Primary Examiner(s): Shaver, Kevin
• Assistant Examiner(s): Priddy, Michael B.
• Application Number:
  US09/496,987
• Time in Patent Office: 1,532 Days
• Field of Search: 606/92, 606/94, 606/93, 604/528, 604/529, 604/21, 604/43, 604/93.01, 604/257, 604/264, 604/272, 604/275, 604/279, 604/523, 222/330, 222/386, 222/478
• US Class Current: 606/92
• CPC Class Codes: A61B 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• CPC Class Codes: A61B 17/8816 characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
• CPC Class Codes: A61B 17/8819 characterised by the introducer proximal part, e.g. cannula handle, or by parts which are inserted inside each other, e.g. stylet and cannula A61B17/8825 takes precedence
• CPC Class Codes: A61B 17/8836 for heating, cooling or curing of bone cement or fluid fillers
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61F 2002/4635 using minimally invasive surgery
• CPC Class Codes: A61F 2002/4653 using cooling means

Abstract

A tube body includes an interior bore to carry a material flow into bone. The tube body includes a dispensing end having an opening communicating with the bore to dispense the material flow. One embodiment provides a cutting element, which extends in the opening to permit passage of the material flow and to sever the material flow in response to rotation of the tube body. Another embodiment deflects the dispensing end from the main axis of the tube body, to facilitate targeted introduction of flowable material, even when the access path does not align the tube body along the natural geometric axes of the treatment site. Another embodiment provides a connector having a rotating fitting, which releasably connects the tube body to a cement injecting tool. The rotating fitting allows the physician to rotate the injection nozzle assembly to control orientation and position in the treatment site, without rotating the associated injection tool itself.

Claims

1. An assembly for injecting flowable material into bone comprising

a tube body including an interior bore to carry a material flow, the tube body including a dispensing end,

a connector to releasably connect the tube body to an injecting tool, the connector including a rotating fitting coupled to the tube body to permit rotation of the tube body relative to the connector, and

a steering mechanism for deflecting the dispensing end through a range of deflected positions.

2. An assembly according to claim 1

wherein the steering mechanism includes a member movable through a range of positions each of which generally marks a position of the dispensing end within the range of deflected positions.

3. An assembly for injecting cement into bone comprising

a tube body including an interior bore to carry a cement flow, the tube body including a dispensing end,

an opening in the dispensing end communicating with the bore to dispense the cement flow,

the tube body including at least one interior lumen adapted to communicate with a source of cooling fluid to circulate cooling fluid along the bore while the dispensing end dispenses the cement flow, and

a cutting element extending in the opening to permit passage of the material flow and to sever the material flow in response to rotation of the tube body.

4. An assembly according to claim 3

and further including means for deflecting the dispensing end.

5. An assembly according to claim 4

and further including a steering mechanism for deflecting the dispensing end through a range of deflected positions.

6. An assembly according to claim 5

wherein the steering mechanism includes a member movable through a range of positions each of which generally marks a position of the dispensing end within the range of deflected positions.

7. An assembly for injecting flowable material into bone comprising

a tube body including an interior bore to carry a material flow, the tube body including a dispensing end having a side wall,

an opening in the side wall of the dispensing end communicating with the bore to dispense the material flow, the dispensing end being sized for rotation within the bone while dispensing the material flow, whereby rotation of the tube body within the bone severs the material flow at the opening, and

a connector to releasably connect the tube body to an injecting tool,

wherein at least one of the connector and tube body includes indicia to gauge orientation of the opening.

8. An assembly for injecting flowable material into bone comprising

a tube body including an interior bore to carry a material flow, the tube body including a dispensing end having a side wall,

an opening in the side wall of the dispensing end communicating with the bore to dispense the material flow, the dispensing end being sized for rotation within the bone while dispensing the material flow, whereby rotation of the tube body within the bone severs the material flow at the opening, and

a connector to releasably connect the tube body to an injecting tool,

wherein the connector includes a rotating fitting coupled to the tube body to permit rotation of the tube body relative to the connector.

9. An assembly according to claim 8

wherein the connector and tube body include indicia to gauge rotation of the tube body relative to the connector.

10. An assembly for injecting flowable material into bone comprising

a tube body including an interior bore to carry a material flow, the tube body including a dispensing end having a side wall,

an opening in the side wall of the dispensing end communicating with the bore to dispense the material flow, the dispensing end being sized for rotation within the bone while dispensing the material flow, whereby rotation of the tube body within the bone severs the material flow at the opening,

a connector to releasably connect the tube body to an injecting tool, and

means for deflecting the dispensing end.

21. A bone cement injection tool comprising

a cartridge for holding bone cement, and

an injector nozzle assembly according to claim 7 or 8 or 15 or 10 or 11 or 13 or 15 or 3 coupled to the cartridge.

11. An assembly for injecting flowable material into bone comprising

a tube body including an interior bore to carry a material flow, the tube body including a dispensing end having a side wall,

an opening in the side wall of the dispensing end communicating with the bore to dispense the material flow, the dispensing end being sized for rotation within the bone while dispensing the material flow, whereby rotation of the tube body within the bone severs the material flow at the opening,

a connector to releasably connect the tube body to an injecting tool, and

a steering mechanism for deflecting the dispensing end through a range of deflected positions.

12. An assembly according to claim 11

wherein the steering mechanism includes a member movable through a range of positions each of which generally marks a position of the dispensing end within the range of deflected positions.

13. An assembly for injecting flowable material into bone comprising

a tube body including an interior bore to carry a material flow, the tube body including a flexible dispensing end,

means on the tube body for deflecting the flexible dispensing end within the bone, and

a connector to releasably connect the tube body to an injecting tool,

wherein the connector includes a rotating fitting coupled to the tube body to permit rotation of the tube body relative to the connector.

14. An assembly according to claim 13

wherein the connector and tube body include indicia to gauge rotation of the tube body relative to the connector.

15. An assembly for injecting flowable material into bone comprising

a tube body including an interior bore to carry a material flow, the tube body including a flexible dispensing end, and

a connector to releasably connect the tube body to an injecting tool, the connector including a rotating fitting coupled to the tube body to permit rotation of the tube body relative to the connector when the tube body is coupled to the injecting tool.

16. An assembly according to claim 15

wherein the connector and tube body include indicia to gauge rotation of the tube body relative to the connector.

17. An assembly according to claim 15

wherein the connector and tube body include indicia to gauge orientation of the tube body relative to the connector.

20. An assembly according to claim 15

and further including a marker carried by the dispensing end to enable visualizing the dispensing end in the bone.

18. An assembly for injecting flowable material into bone comprising

a tube body including an interior bore to carry a material flow, the tube body including a dispensing end,

a connector to releasably connect the tube body to an injecting tool, the connector including a rotating fitting coupled to the tube body to permit rotation of the tube body relative to the connector, and

means for deflecting the dispensing end.

19. An assembly according to claim 18

wherein the connector and tube body include indicia to gauge orientation of tube body deflection.

22. A method for injecting flowable material into bone comprising the steps of

deploying a tube body into bone, the tube body including a dispensing end having a side wall and a side opening in the side wall to dispense a material flow,

injecting a material flow into the bone through the side opening, and

rotating the dispensing end to move the side opening through the material flow and thereby sever the material flow from the side opening.

23. A method according to claim 22

and further including the step of gauging the rotation of the dispensing end.

24. A method according to claim 23

wherein rotation of the dispensing end is gauged without visualizing the dispensing end in the bone.

25. An assembly for injecting flowable material into bone comprising

a tube body including an interior bore to carry a material flow, the tube body including a dispensing end having a side wall,

the tube body further having at least one substantially non-flexible section and at least one substantially flexible section, and

an opening in the side wall of the dispensing end communicating with the bore to dispense the material flow, and

a connector to releasably connect the tube body to an injecting tool

wherein at least one of the connector and tube body includes indicia to gauge orientation of the opening.

28. An assembly a according to claim 25 or 26

and further including means for deflecting the dispensing end.

29. An assembly according to claim 25 or 26

and further including a steering mechanism for deflecting the dispensing end through a range of deflected positions.

30. An assembly according to claim 29

wherein the steering mechanism includes a member movable through a range of positions each of which generally marks a position of the dispensing end within the range of deflected positions.

26. An assembly for injecting flowable material into bone comprising

a tube body including an interior bore to carry a material flow, the tube body including a dispensing end having a side wall,

the tube body further having at least one substantially non-flexible section and at least one substantially flexible section,

an opening in the side wall of the dispensing end communicating with the bore to dispense the material flow, and

a connector to releasably connect the tube body to an injecting tool,

wherein the connector includes a rotating fitting coupled to the tube body to permit rotation of the tube body relative to the connector.

27. An assembly according to claim 26

wherein the connector and tube body include indicia to gauge rotation of the tube body relative to the connector.