UNITARILY FORMED EXPANDABLE SPINAL IMPLANT AND METHOD OF MANUFACTURING AND IMPLANTING SAME

• US 20160206440A1
• Filed: 01/21/2015
• Published: 07/21/2016
• Est. Priority Date: 01/21/2015
• Status: Active Grant

• Current Assignee: Onc. Warsaw Orthopedic
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Ritland, Stephen L., DeRidder, Steven, Marik, Gregory C.
• Granted Patent: US 9,907,670 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• CPC Class Codes: A61F 2/4603 for insertion or extraction of endoprosthetic joints or of accessories thereof
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30153 rectangular
• CPC Class Codes: A61F 2002/30232 Half-cylinders
• CPC Class Codes: A61F 2002/30401 with additional means for preventing or locking said sliding
• 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 2002/30538 for adjusting angular orientation
• CPC Class Codes: A61F 2002/30556 for adjusting thickness
• CPC Class Codes: A61F 2002/30772 Apertures or holes, e.g. of circular cross section
• CPC Class Codes: A61F 2002/30774 internally-threaded
• CPC Class Codes: A61F 2002/30904 serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2002/30968 Sintering
• CPC Class Codes: A61F 2002/3097 using laser
• CPC Class Codes: A61F 2002/30985 using three dimensional printing [3DP]
• 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 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A63F 1/04 Card games combined with other games
• CPC Class Codes: A63F 13/30 Interconnection arrangements between game servers and game devices; Interconnection arrangements between game devices; Interconnection arrangements between game servers
• CPC Class Codes: A63F 2001/008 : adapted for being playable on a screen
• CPC Class Codes: A63F 2009/0484 : Dice with pictures or figures
• CPC Class Codes: B22F 10/28 : Powder bed fusion, e.g. selective laser melting [SLM] or electron beam melting [EBM]
• CPC Class Codes: B22F 5/10 : of articles with cavities or holes, not otherwise provided for in the preceding subgroups
• CPC Class Codes: B33Y 10/00 : Processes of additive manufacturing
• CPC Class Codes: B33Y 80/00 : Products made by additive manufacturing
• CPC Class Codes: Y02P 10/25 : Process efficiency

Abstract

A unitarily formed expandable spinal implant for insertion in a disc space between two adjacent vertebrae. The unitarily formed expandable spinal implant is moveable from an unexpanded configuration to an expanded configuration, and can be manufactured by a 3-dimensional printer. The unitarily formed expandable spinal implant includes an upper portion, a lower portion, a proximal wall, a first distal wall portion, a second distal wall portion, and a separator connected by at least one point of attachment to the spinal implant. A separation tool breaks the separator free from the at least one point of attachment, and moves the separator within the implant to force expansion thereof from the unexpanded configuration to the expanded configuration.

Claims

1. A unitarily formed expandable spinal implant for insertion into a disc space between two adjacent vertebrae, the implant comprising:

a proximal end, an opposite distal end, a mid-longitudinal axis extending through the proximal end and the distal end, and a length along the mid-longitudinal axis between the proximal end and the distal end;

an upper portion having a proximal end, an opposite distal end, an upper portion exterior surface, and an upper portion interior surface, the upper portion exterior surface and the upper portion interior surface extending from at least adjacent the upper portion proximal end to at least adjacent the upper portion distal end, the upper portion exterior surface being configured to contact one of the two adjacent vertebrae, the upper portion interior surface at least in part declining between the upper portion proximal end and the upper portion distal end, and at least one opening being provided in the upper portion between the upper portion interior surface and the upper portion exterior surface thereof;

a lower portion having a proximal end, an opposite distal end, a lower portion exterior surface, and a lower portion interior surface, the lower portion exterior surface and the lower portion interior surface extending from at least adjacent the lower portion proximal end to at least adjacent the lower portion distal end, the lower portion exterior surface configured to contact the other of the two adjacent vertebrae, the lower portion interior surface at least in part inclining between the lower portion proximal end and the lower portion distal end, and at least one opening being provided in the lower portion between the lower portion interior surface and the lower portion exterior surface thereof;

a proximal wall having an exterior surface and an interior surface, the proximal wall extending between the upper portion and the lower portion, the proximal wall having a maximum height, and an aperture provided in the proximal wall between the interior surface and the exterior surface thereof, the aperture provided in the proximal wall communicating with the chamber;

a chamber defined between portions of the upper portion interior surface, the lower portion interior surface, and the interior surface of the proximal wall;

a first distal wall portion and a second distal wall portion, the first distal wall portion being attached to the upper portion at the distal end thereof, the second distal wall portion being attached to the lower portion at the distal end thereof, the first distal wall portion and the second distal wall portion having a first height less than the maximum height of the proximal wall; and

a separator including a leading portion, the separator being unitarily formed with one of the upper portion interior surface, the lower portion interior surface, and the interior surface of the proximal wall;

wherein the separator is configured to be separated from the one of the upper portion interior surface, the lower portion interior surface, and the interior surface of the proximal wall, and be moved along at least a portion of the lower portion interior surface and at least a portion of the upper portion interior surface toward the first distal wall portion and the second distal wall portion to move the upper portion and the lower portion apart from one another into an expanded configuration, the first distal wall portion and the second distal wall portion having a second height in the expanded configuration greater than the maximum height of the proximal wall.

2. The expandable spinal implant of claim 1, wherein the separator is separably attached to the one of the upper portion interior surface, the lower portion interior surface, and the interior surface of the proximal wall by at least one point of attachment.

3. The expandable spinal implant of claim 1, wherein the upper portion interior surface includes a concave portion adjacent the first distal wall portion, and the lower portion interior surface includes a concave portion proximate the second distal wall portion.

4. The expandable spinal implant of claim 3, wherein the concave portions of the upper portion interior surface and the lower portion interior surface are configured to receive therein portions of the separator, the concave portions inhibiting further movement of the separator along the lower portion interior surface and the upper portion interior surface.

5. The expandable spinal implant of claim 2, further comprising an insertion tool configured to be inserted through the aperture in the proximal wall, and into contact with the separator to break the separator free from the at least one point of attachment, and move the separator toward the first distal wall portion and the second distal wall portion.

6. The expandable spinal implant of claim 5, wherein the separator includes an aperture, and the insertion tool includes a distal end configured to fit into the aperture of the separator.

7. The expandable spinal implant of claim 1, wherein the spinal implant is formed at least in part by titanium powder.

8. The expandable spinal implant of claim 1, wherein the chamber between the upper portion and the lower portion is configured to receive bone growth material therein.

9. The expandable spinal implant of claim 1, wherein the at least one opening in the upper portion and the at least one opening in the lower portion are configured for bone growth therethrough between the two adjacent vertebrae.

10. A method of manufacturing a unitarily formed expandable spinal implant for implantation in a disc space between two adjacent vertebrae, the method comprising:

utilizing a 3-dimensional printer to lay down sequential layers of an upper portion having a proximal end and an opposite distal end, the upper portion having an upper portion exterior surface and an upper portion interior surface, the upper portion exterior surface and the upper portion interior surface extending from at least adjacent the upper portion proximal end to at least adjacent the upper portion distal end, the upper portion exterior surface being configured to contact one of the two adjacent vertebrae, the upper portion interior surface at least in part declining between the upper portion proximal end and the upper portion distal end, and at least one opening being defined between the upper portion interior surface and the upper portion exterior surface;

utilizing the 3-dimensional printer to lay down sequential layers of a lower portion having a proximal end and an opposite distal end, the lower portion having a lower portion exterior surface and a lower portion interior surface, the lower portion exterior surface and the lower portion interior surface extending from at least adjacent the lower portion proximal end to at least adjacent the lower portion distal end, the lower portion exterior surface being configured to contact the other of the two adjacent vertebrae, the lower portion interior surface at least in part inclining between the lower portion proximal end and the lower portion distal end, and at least one opening being defined between the lower portion interior surface and the lower portion exterior surface;

utilizing the 3-dimensional printer to lay down sequential layers of a proximal wall having an exterior surface and an interior surface, the proximal wall extending between the upper portion and the lower portion, the proximal wall having a maximum height, and an aperture provided in the proximal wall between the interior surface and the exterior surface thereof, the aperture provided in the proximal wall communicating with a chamber formed between portions of the upper portion interior surface and the lower portion interior surface;

utilizing the 3-dimensional printer to lay down sequential layers of a first distal wall portion and a second distal wall portion, the first distal wall portion being attached to the upper portion at the distal end thereof, the second distal wall portion being attached to the lower portion at the distal end thereof, the first distal wall portion and the second distal wall portion having a first height less than the maximum height of the proximal wall; and

utilizing the 3-dimensional printer to lay down sequential layers of a separator including a leading portion, the separator being unitarily formed with one of the upper portion interior surface, the lower portion interior surface, and the interior surface of the proximal wall by at least one point of attachment;

wherein the separator is configured to be separated from the at least one point of attachment, and be moved along at least a portion of the lower portion interior surface and at least a portion of the upper portion interior surface toward the first distal wall portion and the second distal wall portion to move the upper portion and the lower portion apart from one another into an expanded configuration, the first distal wall portion and the second distal wall portion having a second height in the expanded configuration greater than the maximum height of the proximal wall.

11. The method claim 10, further comprising utilizing the 3-dimensional printer to lay down sequential layers of an insertion tool configured to separate the separator from the at least one point of attachment and move the separator along the portions of the lower portion interior surface and the upper portion interior surface.

12. The method of claim 10, wherein titanium powder is used with the 3-dimensional printer to manufacture the unitarily formed expandable spinal implant.

13. A method of implanting a unitarily formed expandable spinal implant into a disc space between two adjacent vertebrae, the method comprising:

utilizing the unitarily formed expandable spinal implant comprising;

an upper portion having a proximal end, an opposite distal end, an upper portion exterior surface, and an upper portion interior surface, the upper portion exterior surface and the upper portion interior surface extending from at least adjacent the upper portion proximal end to at least adjacent the upper portion distal end, the upper portion exterior surface being configured to contact one of the two adjacent vertebrae, the upper portion interior surface at least in part declining between the upper portion proximal end and the upper portion distal end, and at least one opening being defined between the upper portion interior surface and the upper portion exterior surface;

a lower portion having a proximal end, an opposite distal end, a lower portion exterior surface, and a lower portion interior surface, the lower portion exterior surface and the lower portion interior surface extending from at least adjacent the lower portion proximal end to at least adjacent the lower portion distal end, the lower portion exterior surface being configured to contact the other of the two adjacent vertebrae, the lower portion interior surface at least in part inclining between the lower portion proximal end and the lower portion distal end, and at least one opening being defined between the lower portion interior surface and the lower portion exterior surface;

a proximal wall having an exterior surface and an interior surface, the proximal wall extending between the upper portion and the lower portion, the proximal wall having a maximum height, and an aperture provided in the proximal wall between the interior surface and the exterior surface thereof;

a chamber formed between portions of the upper portion interior surface, the lower portion interior surface, and the interior surface of the proximal wall, the aperture formed in the proximal wall communicating with the chamber;

a first distal wall portion and a second distal wall portion, the first distal wall portion being attached to the upper portion at the distal end thereof, the second distal wall portion being attached to the lower portion at the distal end thereof, the first distal wall portion and the second distal wall portion having a first height less than the maximum height of the proximal wall; and

a separator including a leading portion, the separator being unitarily formed with the spinal implant by at least one point of attachment;

wherein the separator is configured to be separated from the at least one point of attachment and be moved along at least a portion of the lower portion interior surface and at least a portion of the upper portion interior surface toward the first distal wall portion and the second distal wall portion to move the upper portion and the lower portion apart from one another into an expanded configuration, the first distal wall portion and the second distal wall portion having a second height in the expanded configuration greater than the maximum height of the proximal wall;

inserting the spinal implant into the disc space;

inserting an insertion tool through the aperture defined in the proximal wall and into contact with the separator;

applying force to the separator with the insertion tool to break the at least one point of attachment; and

forcing the separator along the upper portion interior surface and the lower portion interior surface toward the first distal wall portion and the second distal wall portion to move the upper portion and the lower portion apart from one another into the expanded configuration.

14. The method of claim 13, further comprising inserting bone growth material through the aperture defined in the proximal wall and into the chamber after the implant is inserted in the disc space.

16. The method of claim 13, wherein one of the upper portion interior surface and the lower portion interior surface includes a concave portion for receiving a portion of the separator therein.

17. The method of claim 16, wherein the concave portion is configured to inhibit further movement of the separator along the lower portion interior surface and the upper portion interior surface.

18. The method of claim 13, wherein the separator includes an aperture, and the insertion tool includes a distal end configured to fit into the aperture of the separator.

20. The method of claim 13, wherein the chamber between the upper portion and the lower portion is configured to receive bone growth material therein, and wherein the at least one opening in the upper portion and the at least one opening in the lower portion are configured for bone growth therethrough between the two adjacent vertebrae through the chamber.

15. The method of dam 13, wherein the separator is separably attached via the at least one point of attachment to the one of the upper portion interior surface, the lower portion interior surface, and the interior surface of the proximal wall.

19. The method of dam 13, wherein the spinal implant is formed at least in part by titanium powder.