Low pressure delivery system and method for delivering a solid and liquid mixture into a target site for medical treatment

• US 9,301,792 B2
• Filed: 01/26/2007
• Issued: 04/05/2016
• Est. Priority Date: 01/27/2006
• Status: Active Grant

• Current Assignee: Stryker Corporation
• Original Assignee: Stryker Corporation
• Inventors: Huyser, Richard F, Henniges, Bruce D, Tyler, Douglas L
• Primary Examiner(s): LAWSON, MATTHEW JAMES
• Application Number:
  US11/627,771
• Publication Number:
  US 20070233146A1
• Time in Patent Office: 3,357 Days
• Field of Search: 606 92- 94, 604523-527, 604 57- 64, 604272-274, 623 1711- 1716
• US Class Current: 1/1
• 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 system for forming an implant to stabilize a vertebral body having an interior of cancellous bone, said system comprising:

a delivery cannula defining a delivery passage for providing access to the interior of the vertebral body;

a plurality of elements disposed adjacent to one another in said delivery passage of said delivery cannula with a void space defined among said elements, said plurality of elements including a first element adjacent to a second element;

a fluent material capable of setting to a hardened condition disposed within at least a portion of said void space in said delivery passage; and

a push rod slidably disposed within said delivery passage of said delivery cannula to apply a force to said first element to push said first element in said delivery passage and transfer the force through said first element to said second element to move said elements through said delivery passage and into the interior of the vertebral body, said elements simultaneously carrying said fluent material therewith through said delivery passage and into the interior of the vertebral body upon application of said force to said first element whereby said fluent material sets to the hardened condition to secure said elements and form the implant,

said delivery cannula including a delivery wall surrounding said delivery passage wherein said delivery wall defines at least one groove separate from said delivery passage, said at least one groove open to said delivery passage and configured to allow said fluent material to flow around said elements and to allow said fluent material to backflow from said void space into said at least one groove so that pressurization of said fluent material is reduced.

2. A system as set forth in claim 1 wherein said delivery cannula includes one or more extension ribs extending radially inwardly from said delivery wall to radially support said elements and define said at least one groove.

3. A system as set forth in claim 1 wherein said plurality of elements are disposed in said delivery passage in a linear array and include at least three elements and at least two void spaces.

4. A system as set forth in claim 1 wherein said delivery passage of said delivery cannula extends along a delivery axis and said delivery cannula further defines an exit port open to said delivery passage for allowing said elements and said fluent material to exit said delivery cannula and enter the interior of the vertebral body.

5. A system as set forth in claim 1 wherein said elements are flexibly connected.

6. A system as set forth in claim 1 further including an access cannula defining an access passage for accessing the interior of the vertebral body wherein said delivery cannula is sized for insertion in said access passage of said access cannula.

7. A system as set forth in claim 1 wherein said push rod and said delivery cannula define at least one gap therebetween for allowing said fluent material to backflow through said gap as said push rod is moved along said delivery passage of said delivery cannula.

8. A system as set forth in claim 7 wherein said push rod defines a hole for allowing said fluent material to backflow through said hole as said push rod is moved along said delivery passage of said delivery cannula.

9. A system as set forth in claim 7 wherein said push rod has a minimum dimension T and said push rod and said delivery cannula define a space therebetween for allowing said fluent material to backflow through said space as said push rod is moved along said delivery passage of said delivery cannula.

10. A system as set forth in claim 1 further including a delivery mechanism adapted to engage said push rod and said delivery cannula to provide said force of said push rod while holding said delivery cannula to allow relative movement between said push rod and said delivery cannula and move said elements and said fluent material along said delivery passage and into the interior of the vertebral body.

11. A system as set forth in claim 1 wherein said fluent material is bone cement.

12. A system as set forth in claim 1 wherein said plurality of elements are further defined as having a generally spherical shape.

13. A system as set forth in claim 1 wherein said first element is abutting said second element such that said force applied by said push rod is transferred from said first element to said second element without pressurizing said fluent material in said void space.

14. A system for forming an implant in a non-soft body tissue, the system comprising:

a delivery cannula configured for insertion into the non-soft body tissue and having an open distal end and a proximal end opposite the distal end;

an agglomeration of solid beads and fluent material contained within the delivery cannula, the solid beads not being interconnected, the fluent material being capable of setting into a hardened condition;

a delivery mechanism attached to the proximal end of the delivery cannula and being configured to urge the agglomeration out of the distal end of the delivery cannula;

a first passage configured to hold the solid beads adjacent one another along a delivery axis such that void spaces are defined between the solid beads;

a second passage, separate from the first passage, opening into the first passage at a location distal to the proximal end of the delivery cannula, the second passage being configured to allow the fluent material to flow therethrough and into the void spaces between the solid beads and configured to allow the fluent material to backflow from the void spaces into the second passage so that pressurization of the fluent material is reduced; and

a plurality of ribs configured to radially support the solid beads and confine the solid beads to the first passage, the first passage being radially inward of the second passage.

15. A system as set forth in claim 14, the first passage being configured to hold the solid beads in a linear array centered along the delivery axis.

16. A system as set forth in claim 14, the ribs defining grooves therebetween, the second passage being formed by the grooves.

17. A system as set forth in claim 14, the second passage opening into the first passage at multiple locations proximal to the distal end of the delivery cannula.

18. A system as set forth in claim 14, the first passage extending alongside the second passage.

19. A system as set forth in claim 18, the first passage being parallel to the second passage.

20. A system as set forth in claim 14, comprising a push rod shaped and sized for insertion into the delivery cannula to move the agglomeration through the delivery cannula.