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

• US 8,128,633 B2
• Filed: 12/09/2009
• Issued: 03/06/2012
• Est. Priority Date: 11/18/2005
• Status: Active Grant

• Current Assignee: Stryker Corporation
• Original Assignee: CareFusion 2200 Inc (Becton, Dickinson & Co)
• Inventors: Linderman, Evan D., Krueger, John A.
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US12/634,366
• Publication Number:
  US 20100121336A1
• Time in Patent Office: 818 Days
• Field of Search: 606/94, 606/264, 606/93, 606/92, 606/185, 604/272, 604/164.01, 604/506, 604/164.11, 604/187, 604/95.01, 604/82, 604/264, 433/224, 222/386.5, 222/399
• US Class Current: 606/94
• 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. The device may be used to create voids for receiving curable material, and may include spacers configured to control location and/or orientation of the voids.

Claims

1. 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 closed distal end having a blunt tip,

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, and

a handle forming a fluid port fluidly coupled to the proximal end;

a guide cannula including an elongate tubular body extending distally from a guide cannula hub and housing a lumen configured that receives the deflectable segment in a proximal lumen end, the tubular body having a length such that the deflectable segment extends by a first distance from a distal end of the guide cannula when the delivery cannula handle contacts the guide cannula hub; and

at least one spacer

including a spacer lumen configured to slidingly receive the delivery cannula, and

having a longitudinal first spacer length configured to occupy a longitudinal exterior region along the delivery cannula between the delivery cannula handle and the guide cannula hub such that, when spacer lumen is disposed around the delivery cannula between the delivery cannula handle and the guide cannula handle, the deflectable segment may extend beyond the distal end of the guide cannula only up to a second distance that is less than the first distance, wherein the maximum difference between the first distance and the second distance is equal to the first spacer length, and wherein the spacer permits linear non-rotary longitudinal movement of the delivery cannula through the spacer lumen.

2. The cannula device of claim 1, wherein the at least one spacer and the delivery cannula each comprise complementary detent structures configured to engage each other.

3. The cannula device of claim 1, wherein the at least one spacer includes a generally columnar construction and includes an elongate opening along one side and in mechanical communication with the spacer lumen such that the spacer may be mounted to the delivery cannula by passage of a cannula portion through the elongate opening into the spacer lumen while a portion of the delivery cannula is engaged into the guide cannula lumen.

4. The cannula device of claim 1, wherein the at least one spacer comprises indicia selected from visual indicia, tactile indicia, and a combination thereof.

5. The cannula device of claim 4, wherein the indicia comprise at least one of size data, order of use data, and end orientation data.

6. The cannula device of claim 1, wherein the at least one spacer comprises a plurality of spacers.

7. The cannula device of claim 6, wherein each of the plurality of spacers comprises indicia selected from visual indicia, tactile indicia, and a combination thereof, and the indicia of each of the plurality of spacers distinguishes it from all others of the plurality of spacers.

8. The cannula device of claim 1, wherein the at least one spacer is configured to be removable from the region along the delivery cannula between the delivery cannula handle and the guide cannula hub without movement of delivery cannula handle and the guide cannula hub when the deflectable segment of the delivery cannula occupies the guide cannula lumen.

9. 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;

mounting a first at least one spacer around the delivery cannula in a manner limiting distal longitudinal movement distance of the delivery cannula relative to the guide cannula;

distally advancing the delivery cannula such that the distal end and at least a portion of the deflectable segment projects distal of the distal tip of the guide cannula by the second distance which is limited by the spacer length of the first at least one spacer, characterized by the portion of the deflectable segment that is distal of the distal tip naturally reverting to the curved shape;

manipulating the delivery cannula such that at least a portion of the deflectable segment creates a first void 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 first void.

10. The method of claim 9, wherein the first at least one spacer comprises indicia corresponding to its predetermined length.

11. The method of claim 9, wherein the step of manipulating includes rotating the delivery cannula at least partially about its longitudinal axis.

12. The method of claim 9, further comprising a step of removing the first at least one spacer.

13. The method of claim 12, further comprising steps of:

moving the delivery cannula longitudinally so that the at least a portion of the deflectable segment projects distal of the distal tip of the guide cannula by a third distance different than the second distance; and

manipulating the delivery cannula such that at least a portion of the deflectable segment creates a second void in soft body tissue within the bone structure.

14. The method of claim 12, further comprising steps of:

mounting a second spacer having a second spacer length, different than the first spacer length, around the delivery cannula in a manner limiting distal longitudinal movement distance of the delivery cannula relative to the guide cannula; and

manipulating the delivery cannula such that at least a portion of the deflectable segment creates a second void in soft body tissue within the bone structure.

15. The method of claim 14, further comprising a step of delivering the curable material to the second void.

16. The method of claim 9, further comprising the steps of:

measuring the bone structure; and

selecting the first at least one spacer based upon a desirable length thereof for directing the blunt tip of the delivery cannula to a desired location within the bone structure.

17. A kit for performing a vertebroplasty procedure, the kit comprising:

a delivery cannula including;

a proximal end handle including a proximal fluid port configured for connection with a curable material delivery device,

an elongate tubular member extending distally from the handle and including a deflectable segment opposite the proximal end handle, the deflectable segment terminating in a closed distal end having a blunt tip, and

a lumen extending through the tubular member from the proximal end handle, 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;

a guide cannula including;

an elongate tubular body extending distally from a guide cannula hub and housing a guide lumen configured to receive the deflectable segment in a proximal end, the tubular body configured with a length such that the deflectable segment extends by a first distance from a distal end of the guide cannula when the delivery cannula handle contacts the guide cannula hub; and

at least one spacer including

a spacer length and

a central lumen in open communication with an elongate side aperture that is mountable upon the delivery cannula when the elongate tubular member of the delivery cannula is engaged into the elongate tubular body of the guide cannula,

the central lumen providing for longitudinal non-rotary movement of the delivery cannula through the central lumen,

where the spacer length is configured to occupy a region along the delivery cannula between the delivery cannula handle and the guide cannula hub such that the deflectable segment may extend beyond the distal end of the guide cannula by a second distance that is less than the first distance,

wherein the difference between the first distance and the second distance is less than or equal to the spacer length.

18. The kit of claim 17, wherein the at least one spacer comprises a second spacer having a different length than a first at least one spacer.

19. The kit of claim 18, wherein the spacers each comprise indicia differentiating them from each other.

20. 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, and

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

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

a spacer configured to control longitudinal distance of engagement of the delivery cannula with the guide cannula, wherein the spacer is engaged around and is laterally removable from the delivery cannula when the delivery cannula is engaged into the inner diameter of the guide cannula;

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.