Systems and methods for injecting flowable materials into bones

• US 6,048,346 A
• Filed: 08/13/1997
• Issued: 04/11/2000
• Est. Priority Date: 08/13/1997
• Status: Expired due to Term

• Current Assignee: Orthophoenix, LLC (Marathon Patent Group, Inc.)
• Original Assignee: Kyphon Incorporated
• Inventors: Scholten, Arie, Reiley, Mark A, Scribner, Robert M, Reo, Michael L
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): NGO, LIEN M
• Application Number:
  US08/910,809
• Time in Patent Office: 972 Days
• Field of Search: 606/92, 606/94, 606/62, 606/67, 606/72, 606/83, 606/192, 623/19, 623/16, 623/22, 623/23, 604/56, 604/96, 222/391, 222/327
• 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,

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

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

16. An assembly according to claim 1 wherein the cutting element comprises a single wire filament.

17. An assembly according to claim 1 wherein the cutting element comprises more than one wire filament.

18. An assembly according to claim 1 wherein the cutting element is secured to the dispensing end.

19. An assembly according to claim 1 and further including a connector to releasably connect the tube body to an injecting tool.

20. An assembly according to claim 1 and further including a mechanism for deflecting the dispensing end.

21. An assembly according to claim 20 wherein the mechanism comprises at least one steering wire in the tube body coupled to the dispensing end.

22. An assembly according to claim 1 and further including a steering mechanism for deflecting the dispensing end through a range of deflected positions.

23. An assembly according to claim 22 wherein the steering mechanism includes an member movable through a range of positions each of which generally marks a position of the dispensing end within the range of deflected positions.

24. An assembly according to claim 1 wherein the tube body includes indicia to gauge extent of penetration of the dispensing end into bone.

2. 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,

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

a cutting element comprising a single wire filament 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 2 or 3 wherein the cutting element is secured to the dispensing end.

5. An assembly according to claim 2 or 3 and further including a connector to releasably connect the tube body to an injecting tool.

10. An assembly according to claim 2 or 3 or 9 or 8 wherein the tube body includes indicia to gauge extent of penetration of the dispensing end into bone.

15. A method according to claim 5 or 6 and further including the step of visualizing the dispensing end in the bone.

3. 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,

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

a cutting element comprising more than one wire filament 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.

6. 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,

an opening in the dispensing end communicating with the bore to dispense the material 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, and

a mechanism to deflect the dispensing end.

7. An assembly according to claim 6 wherein the mechanism comprises at least one steering wire in the tube body coupled to the dispensing end.

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,

an opening in the dispensing end communicating with the bore to dispense the material 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, and

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

9. An assembly according to claim 8 wherein the steering mechanism includes an member movable through a range of positions each of which generally marks a position of the dispensing end within the range of deflected positions.

11. 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 an opening to dispense a material flow and a cutting element extending in the opening adjacent the dispensing end,

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

rotating the dispensing end to move the cutting element through the material flow and thereby sever the material flow adjacent the dispensing end.

25. A method according to claim 11 and further including the step of deflecting the dispensing end in the bone.

26. A method according to claim 25 and further including the step of gauging orientation of the dispensing end before, during, or after the deflecting step.

27. A method according to claim 26 wherein orientation of the dispensing end is gauged without visualizing the dispensing end in the bone.

28. A method according to claim 11 and further including the step of visualizing the dispensing end in the bone.

12. 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 an opening to dispense a material flow and a cutting element extending in the opening,

injecting a material flow into the bone through the opening,

rotating the dispensing end to move the cutting element through the material flow and thereby sever the material flow from the opening, and

deflecting the dispensing end in the bone.

13. A method according to claim 12 and further including the step of gauging orientation of the dispensing end before, during, or after the deflecting step.

14. A method according to claim 13 wherein orientation of the dispensing end is gauged without visualizing the dispensing end in the bone.