Method and apparatus for augmenting bone

• US 10,413,340 B2
• Filed: 05/11/2018
• Issued: 09/17/2019
• Est. Priority Date: 08/19/2009
• Status: Active Grant

• Current Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Original Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Inventors: Teisen, Jacques
• Primary Examiner(s): Yang, Andrew
• Application Number:
  US15/977,454
• Publication Number:
  US 20180256216A1
• Time in Patent Office: 494 Days
• CPC Class Codes: A61B 17/1642 for producing a curved bore
• CPC Class Codes: A61B 17/1662 for particular parts of the body
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 17/8872 Instruments for putting said fixation devices against or away from the bone A61B17/7074, A61B17/808 take precedence
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel

Abstract

An expandable implant system is configured to increase the height of a target bone, for instance that has been subjected to a compression fracture. The expandable implant system includes an implant assembly that can be inserted into the target bone, and subsequently expanded so as to increase the height of the target bone. The expandable implant system further includes an and insertion assembly that is configured to create an insertion channel into the target bone, such that the implant assembly can be inserted in a collapsed configuration into the target bone along the insertion channel, and subsequently expanded.

Claims

1. An expandable implant assembly for insertion within patient anatomy, the assembly comprising:

a primary implant elongate along a central axis and configured to expand, within the anatomy, radially outward from the central axis from an insertion configuration to an expanded configuration, the primary implant including an inner surface that defines an internal void; and

an auxiliary implant configured to reside in the internal void and expand radially outward from the central axis from a collapsed configuration to an expanded configuration against the inner surface of the primary implant, the auxiliary implant defining a central body portion and at least first and second nodes each extending outwardly from the central body portion along respective radial directions perpendicular to the central axis, the central axis extending through the central body portion, wherein each of the at least first and second nodes defines;

a neck; and

a foot spaced outwardly from the neck along the respective radial direction, the foot configured to abut the inner surface of the primary implant, the neck extending from the foot to a respective leg of the central body portion, the leg defining a pair of side surfaces, wherein, when the auxiliary implant is in the expanded configuration;

the foot defines a circumferential dimension about the central axis greater than a circumferential dimension of the neck about the central axis, and

a circumferential width of the respective leg measured between the respective pair of side surfaces does not decrease along the leg toward the central axis.

2. The expandable implant assembly of claim 1, wherein the at least first and second nodes comprise a third node, the central body portion has a substantially triangular shape in a reference plane orthogonal to the central axis, and the respective legs define respective vertices of the central body portion.

3. The expandable implant assembly of claim 2, wherein the substantially triangular shape is substantially equilateral.

4. The expandable implant assembly of claim 1, wherein the central body portion and the at least first and second nodes are configured to at least partially define at least first and second pockets that extend respectively between the at least first and second nodes.

5. The expandable implant assembly of claim 4, further comprising bone stimulating material configured to be inserted into the at least first and second pockets.

6. The expandable implant assembly of claim 1, wherein the primary implant comprises a plurality of linkages arranged in at least one annular row of connected linkages, each of the plurality of linkages defining first and second opposed side portions connected by corresponding first and second end portions, the first and second side portions defining a distance therebetween, such that the distance is configured to increase as the at least first and second impart an expansion force to the inner surface of the primary implant so as to expand the primary implant to the expanded configuration.

7. The expandable implant assembly of claim 1, wherein the auxiliary implant comprises a body that defines an interior volume that is configured to be filled with a bone filler material so as to expand the body from the collapsed configuration to the expanded configuration.

8. The expandable implant assembly of claim 7, wherein the primary implant is substantially cylindrical when the primary implant is in the expanded configuration.

9. The expandable implant assembly of claim 7, wherein the central axis of the primary implant is substantially straight when the primary implant is in the expanded configuration.

10. The expandable implant assembly of claim 7, wherein the central axis of the primary implant is curved when the primary implant is in the expanded configuration.

11. The expandable implant assembly of claim 10, wherein the body of the auxiliary implant defines opposed first and second sides that are elongate along respective first and second directions that are parallel with the central axis, the first side defines a first thickness, and the second side defines a second thickness less than the first thickness such that the first side is configured to be convex along the first direction and the second side is configured to be concave along the second direction when the auxiliary implant is in the expanded configuration.

12. The expandable implant assembly of claim 7, wherein the body of the auxiliary implant is folded when in the collapsed configuration.

13. The expandable implant assembly of claim 12, wherein the body unfolds and substantially does not stretch during expansion from the collapsed configuration to the expanded configuration.

14. The expandable implant assembly of claim 1, further comprising an expansion body that is configured to fit into the internal void of the primary implant body when the primary implant is in the insertion configuration and prior to the auxiliary implant residing in the internal void, the expansion body further configured to expand when disposed in the internal void so as to expand the primary implant to its expanded configuration, wherein the auxiliary implant is configured to reside in the internal void after the expansion body is withdrawn from the internal void.

15. The expandable implant assembly of claim 1, wherein the expandable implant assembly is selectively insertable within one of a vertebral body and an intervertebral disc space.

16. A system for inserting at least one expandable implant assembly into a target region of patient anatomy, the system comprising:

a cannulated body configured to advance within the patient anatomy at least to a location adjacent the target region;

a primary implant configured to advance through the at least one cannulated body and into the target region, the primary implant being elongate along a central axis and configured to expand radially outward from the central axis, the primary implant including an inner surface that defines an internal void; and

an auxiliary implant configured to reside in the internal void and expand radially outward from the central axis and against the inner surface of the primary implant, the auxiliary implant defining a central body portion and at least first and second nodes each extending outwardly from the central body portion along respective radial directions perpendicular to the central axis, the central axis extending through the central body portion, wherein each of the at least first and second nodes defines;

a neck; and

a foot spaced outwardly from the neck along the respective radial direction, the foot configured to abut the inner surface of the primary implant, the neck extending from the foot to a respective leg of the central body portion, the leg defining a pair of side surfaces, wherein, when the auxiliary implant is in the expanded configuration;

the foot defines a circumferential dimension about the central axis greater than a circumferential dimension of the neck about the central axis, and

a circumferential width of the respective leg measured between the respective pair of side surfaces does not decrease along the leg toward the central axis.

17. The system of claim 16, further comprising an opening device that defines a proximal end, a distal end spaced from the proximal end, and a cannula extending from the proximal end to the distal end, wherein the distal end includes a cutting edge that is configured to advance distally beyond a distal end of the cannulated body and cut into bone at the target region so as to form a guide path within the target region of the bone, and the primary implant is configured to advance through the cannula of the opening device and along the guide path.

18. The expandable implant assembly of claim 17, wherein the opening device is substantially straight such that the cutting edge cuts a substantially straight guide path within the target bone.

19. The system of claim 17, wherein at least a portion of the opening device located proximally from the distal end is configured to extend 1) substantially axially straight while located within the cannulated body and 2) axially curved after extending beyond the distal end of the cannulated body such that the cutting edge cuts a curved guide path within the target bone, and the primary implant is configured such that the central axis is curved while the primary implant resides within the curved guide path.

20. The system of claim 16, further comprising an expansion body configured to fit within the internal void of the primary implant while the primary implant resides within the target region and before the auxiliary implant resides within the internal void, wherein the expansion body is further configured to expand so as to expand the primary implant radially outward from the central axis to an expanded configuration.

21. The system of claim 20, wherein the expansion body is pre-inserted within the internal void of the primary implant, and the expansion body and the primary implant are configured to advance together through the cannulated body and into the target region.