Method of delivering a plurality of elements and fluent material into a vertebral body

• US 10,426,536 B2
• Filed: 02/29/2016
• Issued: 10/01/2019
• Est. Priority Date: 01/27/2006
• Status: Active Grant

• Current Assignee: Stryker Corporation
• Original Assignee: Stryker Corporation
• Inventors: Henniges, Bruce D., Huyser, Richard F., Tyler, Douglas L.
• Primary Examiner(s): Lawson, Matthew J
• Application Number:
  US15/056,393
• Publication Number:
  US 20160175019A1
• Time in Patent Office: 1,310 Days
• Field of Search: 623 1711- 1716, 606 92- 94
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/7094 Solid vertebral fillers; devices for inserting such fillers
• CPC Class Codes: A61B 17/7095 the filler comprising unlinked macroscopic particles
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• 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 17/8822 characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum

Abstract

A system for forming an implant to stabilize an interior of a vertebral body is provided. The system includes a delivery cannula. A plurality of elements are disposed adjacent to one another in the delivery cannula with void spaces defined between the elements. A fluent material, capable of setting to a hardened condition, is disposed within at least a portion of the void space in the delivery cannula. A push rod is movably disposed within the delivery cannula to apply a force to move the elements through the delivery cannula and into the interior of the vertebral body. Upon application of the force, the elements simultaneously carry the fluent material through the delivery cannula and into vertebral body to delivery the fluent material at a low pressure. The fluent material sets to the hardened condition to secure the elements and form the implant.

Claims

1. A method of delivering elements and a fluent material capable of setting into a hardened condition into a vertebral body having an interior of cancellous bone to form an implant, said method comprising the steps of:

providing a delivery cannula defining a delivery passage and at least one groove separate from and open to the delivery passage, and a push rod;

placing the fluent material at least partially within a void space defined among the elements in the delivery passage of the delivery cannula, wherein the elements are disposed adjacent to one another in the delivery passage; and

inserting the push rod in the delivery passage of the delivery cannula to slide the push rod along the delivery passage and apply a force to a first of the elements and transfer the force through the first element to a second of the elements disposed in the delivery passage to move the elements through the delivery passage and into the interior of the vertebral body such that the fluent material is simultaneously carried with the elements as the elements move through the delivery passage and into the interior of the vertebral body, and such that the fluent material flows from the void space to the at least one groove and backflows around the elements so that pressurization of the fluent material is reduced upon application of the force whereby the fluent material sets to the hardened condition to secure the elements and form the implant.

2. A method as set forth in claim 1 further comprising loading the fluent material into the delivery cannula after the elements are disposed adjacent to one another in the delivery passage.

3. A method as set forth in claim 2, wherein loading the fluent material into the delivery cannula includes attaching a fill container to the delivery cannula and moving the fluent material from the fill container to the delivery cannula so that the fluent material flows around the elements in the delivery passage to at least partially fill in the void space.

4. A method as set forth in claim 3 further comprising sealing an end of the delivery cannula to retain the fluent material within the delivery cannula.

5. A method as set forth in claim 1 further comprising filling a loading cannula with the fluent material and the elements and transferring the fluent material and the elements from the loading cannula to the delivery cannula.

6. A method as set forth in claim 1 further comprising attaching a fill container to the delivery cannula and transferring the fluent material and the elements from the fill container to the delivery cannula.

7. A method as set forth in claim 1 further comprising loading the fluent material into the delivery cannula while a distal containment member holds the elements in the delivery cannula.

8. A method as set forth in claim 7 further comprising removing the distal containment member from the delivery cannula prior to delivering the fluent material and the elements into the vertebral body.

9. A method as set forth in claim 1 further comprising loading the fluent material into a separate delivery passage.

10. A method as set forth in claim 1 further comprising delivering the elements and the fluent material from an exit port radially from the delivery cannula into the interior of the vertebral body.

11. A method as set forth in claim 1, wherein the elements are flexibly connected to one another with a connecting member, said method further comprising moving the access cannula to sever the connecting member with a cutter disposed on a distal end of the access cannula.

12. A method as set forth in claim 1 further comprising measuring a linear distance the push rod travels along the delivery passage of the delivery cannula and estimating a volume of the elements and the fluent material delivered into the interior of the vertebral body based on the linear distance the push rod traveled.

13. A method as set forth in claim 1 further comprising controlling a volumetric ratio of the elements to the fluent material to deliver the fluent material at a desired pressure.

14. A method as set forth in claim 13 further comprising delivering the elements and the fluent material at a volumetric ratio of the elements to the fluent material of from 0.1:

1 to 10;

1.

15. A method as set forth in claim 13 further comprising delivering the elements and the fluent material at a volumetric ratio of the elements to the fluent material of from 0.2:

1 to 5;

1.

16. A method as set forth in claim 13 further comprising delivering the elements and the fluent material at a volumetric ratio of the elements to the fluent material of about 2:

1.

17. A method of delivering elements and a fluent material capable of setting into a hardened condition into a vertebral body having an interior of cancellous bone to form an implant, said method comprising the steps of:

providing a delivery cannula, and a push rod including a pusher;

placing the fluent material at least partially within a void space defined among the elements in a delivery passage of the delivery cannula, wherein the elements are disposed adjacent to one another in the delivery passage; and

inserting the push rod in the delivery passage of the delivery cannula to slide the pusher along the delivery passage and apply a force to move the elements through the delivery passage and into the interior of the vertebral body such that the fluent material is simultaneously carried with the elements as the elements move through the delivery passage and into the interior of the vertebral body, and such that the fluent material backflows past the pusher so that pressurization of the fluent material is reduced upon application of the force, whereby the fluent material sets to the hardened condition to secure the elements and form the implant.

18. The method as set forth in claim 17 wherein the pusher and the delivery cannula define a gap therebetween such that the fluent material backflows through the gap and around the pusher during the step of inserting the push rod.

19. The method as set forth in claim 17 wherein the pusher defines a hole such that the fluent material backflows through the hole during the step of inserting the push rod.