Device, system and method for delivering a curable material into bone

• US 20070142842A1
• Filed: 02/08/2007
• Published: 06/21/2007
• Est. Priority Date: 11/18/2005
• Status: Active Grant

• Current Assignee: Stryker Corporation
• Original Assignee: CareFusion 2200 Inc (Becton, Dickinson & Co)
• Inventors: Linderman, Evan, Krueger, John
• Granted Patent: US 7,799,035 B2
• Time in Patent Office: Days
• US Class Current: 606/92
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• 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 17/8819 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 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/00455 Orientation indicators, e.g. recess on the handle
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2090/062 penetration depth

Abstract

A curable material delivery cannula device is disclosed. The device includes a cannula and a hub. The cannula includes an open proximal end, a deflectable segment forming a pre-set curve, a lumen, and side orifice(s) adjacent, and proximally spaced from, the distal end and fluidly connected to the lumen. When inserted within a guide cannula, the deflectable segment straightens. When distally extended from the guide cannula, the deflectable segment reverts to the curved shape. The distal end has a blunt tip for non-traumatic interface with bodily material. During use, curable material, such as bone cement, is delivered from the side orifice(s) in a radial direction relative to the lumen.

Claims

6. A method of injecting curable material within a bone structure, the method comprising:

providing a delivery cannula defining;

an open, proximal end,

a deflectable segment opposite the proximal end having a distal end,

a lumen extending from the proximal end,

wherein the deflectable segment has a shape memory characteristic and naturally assumes a curved shape in longitudinal extension;

locating a distal tip of a guide cannula within the bone structure;

inserting the delivery cannula within the guide cannula, characterized by the deflectable segment deflecting to a substantially straightened shape within the guide cannula;

distally advancing the delivery cannula such that the distal end and at least a portion of the deflectable segment projects distal the distal tip, characterized by the portion of the deflectable segment distal the distal tip naturally reverting to the curved shape;

positioning the distal end distally adjacent a first region within the delivery site;

delivering the curable material to the first region within the delivery site;

positioning the distal end distally adjacent a second region within the delivery site; and

delivering the curable material to the second region within the delivery site.

7. The method of claim 6 wherein a region between the first region and second region is substantially free of curable material.

8. The method of claim 6 wherein the deflectable segment of the delivery cannula terminates in a closed end and the delivery cannula further comprises a side orifice fluidly connected to the lumen.

9. The method of claim 6 further comprising the step of preloading the delivery cannula with curable material prior to inserting the delivery cannula into the guide cannula.

10. The method of claim 6 wherein the bone structure is a vertebral body.

11. The method of claim 6 wherein the bone structure is a sacrum.

12. A cannula device for delivering a curable material, such as bone cement, into bone as part of a curable material delivery system, the device comprising:

a delivery cannula preloaded with bone cement defining;

an open, proximal end,

a deflectable segment opposite the proximal end and terminating in a closed distal end;

a lumen extending from the proximal end,

at least one side orifice formed adjacent to, and proximally spaced from, the distal end and fluidly connected to the lumen,

wherein the deflectable segment forms a curved shape in longitudinal extension and has a shape memory characteristic such that the deflectable segment is configured to assume a longitudinally, substantially straightened form when subjected to a force and naturally revert to the curved shape upon removal of the force.

1. A method of injecting curable material to a delivery site within a bone structure, the method comprising:

providing a delivery cannula defining;

an open, proximal end,

a deflectable segment opposite the proximal end having a distal end,

a lumen extending from the proximal end, wherein the deflectable segment has a shape memory characteristic and naturally assumes a curved shape in longitudinal extension;

locating a distal tip of a guide cannula within the bone structure;

inserting the delivery cannula within the guide cannula, characterized by the deflectable segment deflecting to a substantially straightened shape within the guide cannula;

distally advancing the delivery cannula such that the distal end and at least a portion of the deflectable segment projects distal the distal tip, characterized by the portion of the deflectable segment distal the distal tip naturally reverting to the curved shape;

manipulating the delivery cannula such that at least a portion of the deflectable segment creates one or more voids in soft body tissue within the bone structure; and

delivering the curable material to the delivery site wherein the curable material is delivered to the one or more voids in the soft body tissue created by the deflectable segment.

2. The method of claim 1 wherein manipulating the delivery cannula comprises retracting at least a portion of the delivery cannula from the delivery site relative to the guide cannula and distally advancing the delivery cannula relative to the guide in a reciprocating manner such that at least a portion of the deflectable segment creates voids in soft body tissue within the bone structure.

3. The method of claim 1 wherein manipulating the delivery cannula comprises rotating the delivery cannula such that at least a portion of the deflectable segment creates voids in the soft body tissue within the bone structure.

4. The method of claim 1 wherein the deflectable segment of the delivery cannula terminates in a closed end and the delivery cannula further comprises a side orifice fluidly connected to the lumen.

5. The method of claim 1 further comprising the step of preloading the delivery cannula with curable material prior to inserting the delivery cannula into the guide cannula.

13. The device of claim 12, wherein the cannula device further comprises a removable cap to cover the open, proximal end.

14. The device of claim 12, wherein the closed end is substantially flat.

15. The device of claim 12, wherein the closed end is substantially sharp.

16. The device of claim 13, wherein the closed end is substantially trocar shaped.

17. The device of claim 12 further comprising a rotatable connector to rotatably connect the delivery cannula with a source of curable material.

18. The device of claim 12, wherein the cannula device further comprises a probe operable to be inserted into the lumen.

19. The device of claim 18, wherein the probe is of a smaller diameter than the lumen to allow material to flow around the probe when inserted into the lumen.

20. A cannula device for delivering a curable material, such as bone cement, into bone as part of a curable material delivery system, the device comprising:

a delivery cannula defining;

an open, proximal end,

a deflectable segment opposite the proximal end and terminating in a distal end;

a lumen extending from the proximal end,

wherein the deflectable segment defines a plurality of curved shapes in longitudinal extension and has shape memory characteristic such that the deflectable segment is configured to assume a longitudinally, substantially straightened form when subjected to a force and naturally revert to the curved shapes upon removal of the force.

21. The device of claim 20, wherein the distal end forms an open end.

22. The device of claim 20, wherein the distal end forms a closed end and comprises at least one side orifice formed adjacent to, and proximally spaced from, the distal end and fluidly connected to the lumen.

23. An intraosseous, curable material delivery system for delivering a curable material such as bone cement to a delivery site within bone, the system comprising:

a delivery cannula defining;

an open, proximal end,

a deflectable segment opposite the proximal end and terminating in a distal end,

a lumen extending from the proximal end, wherein the deflectable segment has a shape memory characteristic and assumes a curved shape in longitudinal extension; and

a guide cannula defining an inner diameter greater than an outside diameter of the delivery cannula and having an open distal tip;

wherein the deflectable segment is configured to be deflectable to a substantially straightened shape such that the delivery cannula is slidable within the guide cannula, and to naturally revert to the curved shape when extended distal the distal tip for delivery of a curable material within implantation site via the distal end; and

wherein the delivery cannula is smoothly slidable within the guide cannula.

24. The system of claim 20, wherein the substantially smoothed outer diameter surface has an RMS value of about 0 to about 16.

25. The system of claim 23, wherein the substantially smoothed outer diameter ace is coated by a layer of Teflon.

20-1. The system of claim 19, wherein the guide cannula has a substantially smoothed inner diameter surface.

21-2. The system of claim 20, wherein the substantially smoothed inner diameter surface has an RMS value of about 0 to about 16.

22-3. The system of claim 21, wherein the substantially smoothed inner diameter surface is coated by a layer of Teflon.

23-4. The system of claim 19, wherein the delivery cannula has a substantially smoothed outer diameter surface.

26. A curable material structure for stabilizing a vertebral body comprising:

a first curable material deposit proximal to an endplate of a vertebral body for providing support to a first endplate of the vertebral body.

a second curable material deposit proximal to an endplate of a vertebral body for providing support to a second endplate of the vertebral body; and

a column of curable material between the first curable material deposit and the second curable material deposit for providing support to the vertebral body.