News Column

Researchers Submit Patent Application, "Spinal Implants, Spinal Implant Kits, and Surgical Methods", for Approval

August 21, 2014



By a News Reporter-Staff News Editor at Politics & Government Week -- From Washington, D.C., VerticalNews journalists report that a patent application by the inventor Theofilos, Charles (Palm Beach Gardens, FL), filed on January 25, 2013, was made available online on August 7, 2014.

The patent's assignee is K2M, Inc.

News editors obtained the following quote from the background information supplied by the inventors: "The present disclosure relates to devices and methods for treating spinal conditions and, more particularly, to spinal implants configured for positioning within the intervertebral space between adjacent vertebral bodies.

"The human spine includes thirty-three vertebrae. The vertebrae interlock with one another to form a spinal column. Each vertebra has a cylindrical bony body (vertebral body), two pedicles extending from the vertebral body, a lamina extending from the pedicles, two wing-like projections extending from the pedicles, a spinous process extending from the lamina, a pars interarticularis, two superior facets extending from the pedicles, and two inferior facets extending from the lamina. The vertebrae are separated and cushioned by thin pads of tough, resilient fiber known as intervertebral discs. Intervertebral discs provide flexibility to the spine and act as shock absorbers during activity. A small opening (foramen) located between each vertebra allows passage of nerves. When the vertebrae are properly aligned, the nerves pass through without a problem. However, when the vertebrae are misaligned or a constriction is formed in the spinal canal, the nerves get compressed and may cause back pain, leg pain, or other neurological disorders."

As a supplement to the background information on this patent application, VerticalNews correspondents also obtained the inventor's summary information for this patent application: "In accordance with the present disclosure, a spinal implant including a substantially U-shaped body, a plate, and a plurality of bone screws is provided. The substantially U-shaped body has first, second, and third walls, A first end of each of the second and third walls is joined to the first wall at opposing ends of the first wall such that the second and third walls define legs of the substantially U-shaped body. The substantially U-shaped body is configured and dimensioned to be positioned between first and second vertebral bodies. The plate has a main portion and a flange portion. The main portion of the plate defines opposed first and second surfaces and a first screw hole oriented towards the first vertebral body at an oblique angle relative to the horizontal axis of the substantially U-shaped body. The flange portion of the plate defines a second screw hole oriented towards the second vertebral body. The second screw hole is oriented substantially parallel to the horizontal axis of the substantially U-shaped body. The flange portion is coupled to the main portion such that the flange portion extends past the first surface of the main portion. Each of the bone screws is insertable through a corresponding screw hole of the plate and is attachable to bone.

"In embodiments, the plate further includes one or more locking mechanisms configured such that, when a bone screw is inserted through a screw hole, the locking mechanism maintains the bone screw within the screw hole. The locking mechanism may include, for example, a locking ring positionable in the screw hole for retaining the bone screw, a lip formed in the screw hole with the screw made of a harder material than the plate such that a thread on the screw, e.g., a second screw thread disposed about the screw head, locks to the lip upon engagement of the screw with the lip, or any other suitable locking mechanism.

"In embodiments, the body is configured and dimensioned such that when the body is inserted between the first and second vertebral bodies, the first surfaces of the body walls contact the first vertebral body and the second surfaces of the body walls contact the second vertebral body.

"In embodiments, first and second surfaces of the body are substantially coplanar with the first and second surfaces of the main portion of the plate.

"In embodiments, the plate is spaced from the body and defines a gap between the body and the plate when the body and the plate main portion are disposed between the first and second vertebral bodies.

"In embodiments, the main portion of the plate includes generally uninterrupted planar surfaces and free ends of the second ends of the second and third walls of the body have generally planar surfaces that contact the generally planar surfaces of the main portion of the plate, such that the main portion of the plate and the body are repositionable relative to each other.

"In embodiments, the body is formed from a first material and the plate is formed from a second material that is different from the first material. Alternatively, the body and plate may be formed from the same material.

"In embodiments, the bone screw insertable through the first screw hole into the first vertebral body is configured for insertion at an oblique angle relative to the horizontal axis of the substantially U-shaped body and the bone screw insertable through the second screw hole into the second vertebral body is configured for insertion substantially parallel to the horizontal axis of the substantially U-shaped body.

"Also provided in accordance with the present disclosure is a spinal interbody kit. The spinal interbody kit includes a body, a first plate, a second plate, and a plurality of bone screws. The body is configured and dimensioned to be inserted between first and second vertebral bodies. The first plate defines a plurality of screw holes and is configured to be spaced from the body to define a gap between the first plate and the body when the body and the first plate are disposed between the first and second vertebral bodies. A first screw hole of the first plate is oriented towards the first vertebral body and a second screw hole of the first plate is oriented towards the second vertebral body. The second plate may be configured similarly to and may include any or all of the features of the plate of the spinal implant described above, e.g., a main body portion and a flange portion. Each of the bone screws is insertable through a corresponding screw hole and is attachable to bone. Preferably, the bone screws are insertable through the screw holes of the first or second plate.

"In embodiments, the kit further includes a plurality of locking rings. Each locking ring is positionable in one of the screw holes and is engagable with a respective bone screw for retaining the respective bone screw in the screw hole. The locking rings may be prepositioned in each hole of the first and second plates.

"In embodiments, the body may further be configured similar to and may include any or all of the features of the body of the spinal implant described above.

"In embodiments, the body is formed from a first material, the first plate is formed from a second material different from the first material, and the second plate is formed from a third material different from the first material. Further, the first and second plates may be formed from the same material. Alternatively, the body and the first plate and/or the second plate may be formed from the same material.

"In embodiments, the material forming the body is non-metallic (e.g., polymeric materials such as polyetheretherketone), bone, or other suitable non-metallic material, while the material forming the first and second plates is metallic, e.g., titanium, or other suitable non-metallic material.

"In embodiments, the body has alignment features that correspond to both the alignment features of the first plate and the alignment features of the second plate.

"In embodiments, the bone screw insertable through the first screw hole of the second plate into the first vertebral body is configured for insertion at an oblique angle relative to the horizontal axis of the substantially U-shaped body and the bone screw insertable through the second screw hole of the second plate into the second vertebral body is configured for insertion substantially parallel to the horizontal axis of the substantially U-shaped body. Further, the bone screws insertable through the first and second screw holes of the first plate into the respective first and second vertebral bodies may be configured for insertion at oblique angles relative to the horizontal axis of the substantially U-shaped body.

"A method of performing surgery provided in accordance with the present disclosure includes providing a surgical kit including a body, first and second plates, and a plurality of bone screws. The kit, or components thereof, may be configured similar to and may include any or all of the features of the embodiments described above. The method further includes preparing an intervertebral space between first and second vertebral bodies to receive the body, inserting the body into the prepared intervertebral space, selecting one of the first or second plates, positioning the selected plate in front of the body, inserting a first screw through the selected plate into one of the vertebral bodies, and inserting a second screw through the selected plate into the other vertebral body.

"In embodiments, positioning the selected plate may further include positioning the selected plate such that a gap is defined between the body and the selected plate.

"In embodiments where the body is a substantially U-shaped body, positioning the body may include positioning the body such that the open end of the substantially U-shaped body faces the direction of insertion.

"In embodiments, the selected plate further includes a screw locking mechanism and inserting the screws further includes locking the screws to the plate.

"In embodiments where the second plate is selected, inserting the first screw includes inserting the first screw through a screw hole of the second plate main portion and into the first vertebral body at an oblique angle relative to the horizontal axis of the body. Inserting the second screw in such embodiments may include inserting the second screw through a screw hole of the flange portion substantially parallel to the horizontal axis of the body and into the second vertebral body.

"In embodiments, inserting the body includes packing the body with material prior to positioning one of the plates in front of the body.

"In embodiments, inserting the body includes introducing the body and one of the first and second plates to the surgical site simultaneously under the common control of a single insertion instrument.

"Another method of surgery provided in accordance with the present disclosure includes providing a surgical kit including a body, first and second plates, and a plurality of bone screws. The kit, or components thereof, may be configured similar to and may include any or all of the features of the embodiments described above. The method further includes preparing an intervertebral space between first and second vertebral bodies to receive the body, selecting one of the first or second plates, inserting the body into the prepared intervertebral space with the selected plate pre-positioned in front of the body, inserting a first screw through the selected plate into one of the vertebral bodies, and inserting a second screw through the selected plate into the other vertebral body.

"In embodiments, pre-positioning the selected plate includes positioning the selected plate such that a gap is defined between the body and the selected plate.

"In embodiments, inserting the body includes packing the body with material prior to pre-positioning one of the plates in front of the body.

"In embodiments where the second plate is selected, inserting the first screw includes inserting the first screw through a screw hole of the second plate main portion into the first vertebral body at an oblique angle relative to the horizontal axis of the body. Further, inserting the second screw may include inserting the second screw through a screw hole of the second plate flange portion substantially parallel to the horizontal axis of the body into the second vertebral body.

BRIEF DESCRIPTION OF THE DRAWINGS

"Various aspects and features of the present disclosure are described with reference to the accompanying drawing figures, wherein:

"FIG. 1A is an exploded, top, perspective view of one embodiment of a spinal implant assembly provided in accordance with the present disclosure;

"FIG. 1B is a front view of the spinal implant assembly of FIG. 1A;

"FIG. 1C is a rear view of the spinal implant assembly of FIG. 1A;

"FIG. 1D is a side view of the spinal implant assembly of FIG. 1A;

"FIG. 1E is a side, cross-sectional view of the spinal implant assembly of FIG. 1A;

"FIG. 2A is a front, perspective view of a plate of the spinal implant assembly of FIG. 1A;

"FIG. 2B is a front view of the plate of FIG. 2A;

"FIG. 3 is a top, perspective view of a body of the spinal implant assembly of FIG. 1A;

"FIG. 4A is a side view of a bone screw configured for use with the spinal implant assembly of FIG. 1A;

"FIG. 4B is a side, cross-sectional view of the bone screw of FIG. 4A;

"FIG. 4C is a top view of the bone screw of FIG. 4A;

"FIG. 5 is a top, perspective view of a locking ring configured for use with the spinal implant assembly of FIG. 1A;

"FIG. 6A is an exploded, top, perspective view of another embodiment of a spinal implant assembly provided in accordance with the present disclosure;

"FIG. 6B is a front view of the spinal implant assembly of FIG. 6A;

"FIG. 6C is a side, cross-sectional view of the spinal implant assembly of FIG. 6A;

"FIG. 7 is a front, perspective view of a plate of the spinal implant assembly of FIG. 6A;

"FIG. 8A is a bottom, perspective view of a unitary spinal implant provided in accordance with the present disclosure;

"FIG. 8B is a top, perspective view of the unitary spinal implant of FIG. 8A;

"FIG. 8C is a side view of the unitary spinal implant of FIG. 8A;

"FIG. 9A is an exploded, top, perspective view of an insertion instrument shown in use with the spinal implant assembly of FIG. 6A;

"FIG. 9B is an enlarged, cross-sectional view of the insertion instrument of FIG. 9A engaged with the spinal implant assembly of FIG. 6A; and

"FIG. 10 illustrates a surgical kit provided in accordance with the present disclosure."

For additional information on this patent application, see: Theofilos, Charles. Spinal Implants, Spinal Implant Kits, and Surgical Methods. Filed January 25, 2013 and posted August 7, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=1507&p=31&f=G&l=50&d=PG01&S1=20140731.PD.&OS=PD/20140731&RS=PD/20140731

Keywords for this news article include: Surgery, K2M Inc., Bone Research, Medical Devices.

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Source: Politics & Government Week


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