Bone fusion device and methods

• US 7,985,231 B2
• Filed: 12/31/2007
• Issued: 07/26/2011
• Est. Priority Date: 12/31/2007
• Status: Active Grant

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: Kyphon SARL (Medtronic Plc)
• Inventors: Sankaran, Meera
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): NEGRELLIRODRIGUEZ, CHRISTINA
• Application Number:
  US11/967,727
• Publication Number:
  US 20090171389A1
• Time in Patent Office: 1,303 Days
• Field of Search: 606/246, 606/61, 606248-249, 606/279, 606/60, 606/259, 606/105, 623 1711- 1716, 623/16.11
• US Class Current: 606/105
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/446 having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
• CPC Class Codes: A61F 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30125 elliptical or oval
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/30153 rectangular
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30383 made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
• CPC Class Codes: A61F 2002/30405 made by screwing complementary threads machined on the parts themselves
• CPC Class Codes: A61F 2002/30471 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2002/30476 locked by an additional locking mechanism
• CPC Class Codes: A61F 2002/30545 for adjusting a diameter
• CPC Class Codes: A61F 2002/3055 for adjusting length
• CPC Class Codes: A61F 2002/30556 for adjusting thickness
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30601 telescopic
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30784 : Plurality of holes
• CPC Class Codes: A61F 2002/30795 : Blind bores, e.g. of circular cross-section
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/3085 : with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
• CPC Class Codes: A61F 2002/4627 : with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4629 : connected to the endoprosthesis or implant via a threaded connection
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2002/4677 : using a guide wire
• CPC Class Codes: A61F 2002/4693 : hydraulic
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0091 : connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0008 : elliptical or oval
• CPC Class Codes: A61F 2230/0015 : Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/0019 : rectangular
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2250/0009 : for adjusting thickness
• CPC Class Codes: A61F 2250/001 : for adjusting a diameter
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00011 : Metals or alloys
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures

Abstract

A bone fusion device can include elongated interlockable segments, each having an engaging surface interlockable with the engaging surface of another segment. The segments can be inserted in between bones one at a time. A device can include an outer expandable component having outer expandable members insertable to a location between bones in an unexpanded configuration and an inner expander including surface engaging portions interlockable with inner surface engaging portions in the outer expandable members. A device can include the inner expander having an outwardly flared proximal portion that can interlock with the proximal end of the outer expandable members. A device can include a locking bridge expandable with an expandable body, such as an inflatable balloon, and movable to a locked expanded configuration. A bone fusion system, a bone fusion device kit, and/or a method for fusing bone can include such a bone fusion device.

Claims

1. A bone fusion device comprising:

a plurality of elongated interlockable segments, each segment having at least a first side and a second side extending transversely to each other along a longitudinal axis of the segment, the segment including at least one longitudinal opening extending along the longitudinal axis and defining a hollow interior region of the segment;

a first engaging surface along the first side; and

a second mateably engaging surface along the second side,

wherein the first engaging surface on a first one of the segments inserted into a location between bones is engageable with the second engaging surface on a second one of the segments inserted into the location so that the first and second segments are interlockable side by side in the location; and

wherein the interlockable segments comprise separate individual elements entirely separable from one another and configured for individual insertion into the location between the bones and structured to be interlocked with one another in situ at the location between the bones by engagement of the first engaging surface with the second engaging surface.

2. The device of claim 1, wherein the first engaging surface further comprises a channel and the second engaging surface further comprises a rib matingly interlocked within the channel in situ at the location between the bones.

3. The device of claim 1, further comprising the longitudinal axis of the segments orientable perpendicularly to a vertical axis of a spinal column.

4. The device of claim 1, wherein each segment includes a plurality of transverse openings extending transversely from an outer surface of the segment and into communication with the at least one longitudinal opening.

5. The device of claim 4, further comprising a bone growth promoting material positioned within the at least one longitudinal opening to promote bone growth into the hollow interior region of the segment.

6. The device of claim 1, wherein the at least one longitudinal opening extends entirely through each segment;

and

further comprising a guide wire positioned within the at least one longitudinal opening and adapted to guide the segment to the location between the bones.

7. The device of claim 6, wherein each segment includes a plurality of transverse openings extending transversely from an outer surface of the segment and into communication with the at least one longitudinal opening.

8. The device of claim 1, further comprising two of the at least one longitudinal opening extending along the longitudinal axis and each defining a hollow interior region of the segment.

9. The device of claim 8, wherein each segment includes a plurality of transverse openings extending transversely from an outer surface of the segment and into communication with at least one of the longitudinal openings.

10. A bone fusion device comprising:

a plurality of elongated interlockable segments, each segment having at least a first side and a second side extending transversely to each other along a longitudinal axis of the segment;

a first engaging surface along the first side; and

a second mateably engaging surface along the second side,

wherein the first engaging surface on a first one of the segments inserted into a location between bones is engageable with the second engaging surface on a second one of the segments inserted into the location so that the first and second segments are interlockable side by side in the location; and

a delivery tube detachably attachable to a proximal end of each of the segments, wherein the delivery tube comprises a size slightly larger than an outer dimension of a single segment such that the device can be delivered to the location utilizing a minimally invasive procedure; and

a guide wire insertable through the delivery tube and through a longitudinal lumen extending along the longitudinal axis in the segment, the guide wire adapted to control a position of the first segment while the second segment is locked to the first segment.

11. A method for fusing bone, comprising:

providing a bone fusion device comprising a plurality of interlockable segments;

positioning a first one of the segments attached to a delivery tube in a location between bones;

detaching the delivery tube from the first segment;

attaching the delivery tube to a second one of the segments;

positioning the second segment with the delivery tube in the location adjacent the first segment;

interlocking the first and second segments in the location; and

detaching the delivery tube from the second segment;

each segment having a guide wire lumen, the method further comprising;

inserting a first guide wire through the delivery tube and a guide wire lumen in the first segment; and

inserting a second guide wire through the delivery tube and a guide wire lumen in the second segment,

wherein interlocking the first and second segments further comprises controlling the position of the first segment in the location with the guide wire while the first and second segments are being interlocked.

12. A bone fusion device comprising:

an outer expandable component having a plurality of outer expandable members each having a length extending along a longitudinal axis of the outer expandable component, the outer expandable component insertable to a location between bones in an unexpanded configuration;

an inner expander movable from a proximal end toward a distal end of the outer expandable component to expand the outer expandable members into an expanded configuration;

inner surface engaging portions in the outer expandable members; and

outer surface engaging portions on the inner expander matingly engageable and interlockable with the inner surface engaging portions in the outer expandable members in the expanded configuration to limit displacement of the outer expandable members away from the inner expander; and

wherein each of the outer expandable members are interlocked with the inner expander by a locking rib that is matingly interlocked within a locking channel to retain the outer expandable members on the inner expander, and wherein the locking rib and the locking channel each have a length extending along the longitudinal axis of the outer expandable component whereby relative axial displacement of the locking rib within the locking channel in a direction along the longitudinal axis expands the outer expandable members into the expanded configuration.

13. The device of claim 12, wherein the outer expandable members comprise separate individual elements that are entirely separable from one another and which are each individually interlocked with the inner expander.

14. The device of claim 12, wherein expansion of the outer expandable members by the inner expander comprises uniform expansion along a longitudinal axis of the outer expandable members to provide the outer expandable component with a substantially uniform height.

15. A bone fusion device comprising:

an outer expandable component having a plurality of outer expandable members each having a length extending along a longitudinal axis of the outer expandable component, the outer expandable component insertable to a location between bones in an unexpanded configuration;

an inner expander movable from a proximal end toward a distal end of the outer expandable component to expand the outer expandable members into an expanded configuration;

inner surface engaging portions in the outer expandable members; and

outer surface engaging portions on the inner expander matingly engageable and interlockable with the inner surface engaging portions in the outer expandable members in the expanded configuration to limit displacement of the outer expandable members away from the inner expander; and

wherein the outer expandable members are separable from each other in a radial direction relative to the longitudinal axis and cooperate with one another to provide the expanded configuration of the outer expandable members with a circular outer cross section along the longitudinal axis.

16. A bone fusion device comprising:

an outer expandable component having a plurality of outer expandable members insertable to a location between bones in an unexpanded configuration;

an inner expander movable from a proximal end toward a distal end of the outer expandable component to expand the outer expandable members into an expanded configuration;

inner surface engaging portions in the outer expandable members; and

outer surface engaging portions on the inner expander matingly engageable and interlockable with the inner surface engaging portions in the outer expandable members in the expanded configuration to limit axial displacement of the outer expandable members away from the inner expander;

wherein each of the outer expandable members are interlocked with the inner expander by a locking rib that is matingly interlocked within a locking channel to retain the outer expandable members on the inner expander;

an inner rod detachably attached to the outer expandable component; and

a pushing tube detachably attached to the inner expander,

wherein the inner expander and the attached pushing tube are slidable about the inner rod so that a distal end of the inner expander is engageable with the outer expandable component.

17. A bone fusion device comprising:

an outer expandable component having a plurality of outer expandable members each having a length extending along lonitudinal axis of the outer expandable component, the outer expandable component insertable to a location between bones in an unexpanded configuration;

an inner expander movable from a proximal end toward a distal end of the outer expandable component to expand the outer expandable members into an expanded configuration;

inner surface engaging portions in the outer expandable members; and

outer surface engaging portions on the inner expander matingly engageable and interlockable with the inner surface engaging portions in the outer expandable members in the expanded configuration to limit displacement of the outer expandable members away from the inner expander; and

wherein the outer surface engaging portions further comprise a plurality of locking flanges extending outwardly from the outer surface of the inner expander, and wherein the inner surface engaging portions in each of the outer expandable members further comprises a locking channel configured to matingly interlock with one of the locking flanges, and wherein the locking flanges and the locking channels each have a length extending along the longitudinal axis of the outer expandable component whereby relative axial displacement of the locking flanges within the locking channels in a direction along the longitudinal axis expands the outer expandable members into the expanded configuration.

18. A bone fusion device comprising:

an outer expandable component comprising a plurality of outer expandable members, each outer expandable member including a number of engaging surfaces positioned in engagement with one or more engaging surfaces of at least one other outer expandable member along at least one separable interface in an unexpanded configuration to define a lumen;

a locking bridge at each interface connecting each outer expandable member with another one of the outer expandable members and movable from the unexpanded configuration to a locked expanded configuration where each of the engaging surfaces is disengaged from the one or more engaging surfaces of the at least one other outer expandable member; and

an expandable body insertable into the lumen of the outer expandable component and adapted to expand the outer expandable members into the expanded configuration,

wherein in the expanded configuration each locking bridge locks the outer expandable members together.

19. The device of claim 18, wherein each locking bridge locked in the expanded configuration between adjacent vertebral body endplates is substantially perpendicular to the endplates.

20. The device of claim 18, wherein each locking bridge is independent from each other locking bridge.

21. The device of claim 18, wherein the locking bridge further comprises:

a flange connected to the interface between two of the outer expandable members along a length of the device and pivotable between the unexpanded configuration and the expanded configuration; and

a terminal locking arm having a center pivot connector pivotably connected on each end of the pivotable flange and an anchor arm anchored to the end of each of the two outer expandable members, the locking arm pivotable between the anchors,

wherein the flange and the terminal locking arm self-lock in the expanded configuration.

22. The device of claim 18, wherein the outer expandable members comprise separate individual elements that are entirely separable from one another and which are locked in the expanded configuration by the locking bridge at each interface location.

23. A method for fusing bone, comprising:

providing a bone fusion device comprising an outer expandable component comprising a plurality of outer expandable members, each outer expandable member including a number of engaging surfaces positioned in engagement with one or more engaging surfaces of at least one other outer expandable member along at least one separable interface in an unexpanded configuration to define a lumen;

inserting an expandable body into the outer expandable component;

expanding the expandable body to expand the outer expandable members into an expanded configuration where each of the engaging surfaces is disengaged from the one or more engaging surfaces of the at least one other outer expandable member; and

the device further comprising a locking bridge at each interface connecting each outer expandable member with another one of the outer expandable members, the method further comprising moving each locking bridge from the unexpanded configuration to a locked expanded configuration to lock the outer expandable members together.

24. The method of claim 23, wherein moving each locking bridge from the unexpanded configuration to an expanded configuration further comprises moving each locking bridge to the expanded configuration between adjacent vertebral body endplates such that each locking bridge is substantially perpendicular to the endplates.

25. The method of claim 23, wherein the outer expandable members comprise separate individual elements that are entirely separable from one another and which are locked in the expanded configuration by the locking bridge at each interface location.