The present invention relates to a prosthetic spinal disc nucleus. More particularly, it relates to a prosthetic spinal disc nucleus having a pre-implant shape for facilitating implantation and a different, post-implant shape for restoring proper spacing and anatomical configuration of an intradiscal space.
The vertebral spine is the axis of the skeleton upon which all of the body parts xe2x80x9changxe2x80x9d. In humans, the normal spine has seven cervical, twelve thoracic and five lumbar segments. The lumbar segments sit upon a sacrum, which then attaches to a pelvis, in turn supported by hip and leg bones. The bony vertebral bodies of the spine are separated by intervertebral discs, which act as joints, but allow known degrees of flexion, extension, lateral bending and axial rotation.
The typical vertebra has a thick interior bone mass called the vertebral body, with a neural (vertebral) arch that arises from a posterior surface of the vertebral body. Each narrow arch combines with the posterior surface of the vertebral body and encloses a vertebral foramen. The vertebral foramina of adjacent vertebrae are aligned to form a vertebral canal, through which the spinal sac, cord and nerve rootlets pass. The portion of the neural arch that extends posteriorly and acts to protect a posterior side of the spinal cord is known as the lamina. Projecting from the posterior region of the neural arch is a spinous process. The central portions of adjacent vertebrae are each supported by an intervertebral disc.
The intervertebral disc primarily serves as a mechanical cushion between the vertebral bones, permitting controlled motions within vertebral segments of the axial skeleton. The normal disc is a unique, mixed structure, comprised of three component tissues: The nucleus pulposus (xe2x80x9cnucleusxe2x80x9d), the anulus fibrosus (xe2x80x9canulusxe2x80x9d), and two opposing vertebral end plates. The two vertebral end plates are each composed of thin cartilage overlying a thin layer of hard, cortical bone which attaches to the spongy, richly vascular, cancellous bone of the vertebral body. The end plates thus serve to attach adjacent vertebrae to the disc. In other words, a transitional zone is created by the end plates between the malleable disc and the bony vertebrae.
The anulus of the disc is a tough, outer fibrous ring that binds together adjacent vertebrae. This fibrous portion, which is much like a laminated automobile tire, is generally about 10 to 15 millimeters in height and about 15 to 20 millimeters in thickness. The fibers of the anulus consist of 15 to 20 overlapping multiple plies, and are inserted into the superior and inferior vertebral bodies at roughly a 30 degree angle in both directions. This configuration particularly resists torsion, as about half of the angulated fibers will tighten when the vertebrae rotate in either direction, relative to each other. The laminated plies are less firmly attached to each other.
Immersed within the anulus, positioned much like the liquid core of a golf ball, is the nucleus. The anulus and opposing end plates maintain a relative position of the nucleus in what can be defined as a nucleus cavity. The healthy nucleus is largely a gel-like substance having a high water content, and similar to air in a tire, serves to keep the anulus tight yet flexible. The nucleus-gel moves slightly within the anulus when force is exerted on the adjacent vertebrae with bending, lifting, etc.
The nucleus and the inner portion of the anulus have no direct blood supply. In fact, the principal nutritional source for the central disc arises from circulation within the opposing vertebral bodies. Microscopic, villous-like fingerlings of the nuclear and anular tissue penetrate the vertebral end plates and allow fluids to pass from the blood across the cell membrane of the fingerlings and then inward to the nuclear tissue. These fluids are primarily body water and the smallest molecular weight nutrients and electrolytes.
The natural physiology of the nucleus promotes these fluids being brought into, and released from, the nucleus by cyclic loading. When fluid is forced out of the nucleus, it passes again through the end plates and then back into the richly vascular vertebral bodies. The cyclic loading amounts to daily variations in applied pressure on the vertebral column (e.g., body weight and muscle pull) causing the nucleus to expel fluids, followed by periods of relaxation and rest, resulting in fluid absorption or swelling by the nucleus. Thus, the nucleus changes volume under loaded and non-loaded conditions. Further, the resulting tightening and loosening effect on the anulus stimulates the normal anulus collagen fibers to remain healthy or to regenerate when torn, a process found in all normal ligaments related to body joints. Notably, the ability of the nucleus to release and imbibe fluids allows the spine to alter its height and flexibility through periods of loading or relaxation. Normal loading cycling is thus an effective nucleus and inner anulus tissue fluid pump, not only bringing in fresh nutrients, but perhaps more importantly, removing the accumulated, potentially autotoxic by-products of metabolism.
The spinal disc may be displaced or damaged due to trauma or a disease process. A disc herniation occurs when the anulus fibers are weakened or torn and the inner tissue of the nucleus becomes permanently bulged, distended, or extruded out of its normal, internal anular confines. The mass of a herniated or xe2x80x9cslippedxe2x80x9d nucleus can compress a spinal nerve, resulting in leg pain, loss of muscle control, or even paralysis. Alternatively, with discal degeneration, the nucleus loses its water binding ability and deflates, as though the air had been let out of a tire. Subsequently, the height of the nucleus decreases, causing the anulus to buckle in areas where the laminated plies are loosely bonded. As these overlapping laminated plies of the anulus begin to buckle and separate, either circumferential or radial anular tears may occur, which may contribute to persistent and disabling back pain. Adjacent, ancillary spinal facet joints will also be forced into an overriding position, which may create additional back pain.
Whenever the nucleus tissue is herniated or removed by surgery, the disc space will narrow and may lose much of its normal stability. In many cases, to alleviate pain from degenerated or herniated discs, the nucleus is removed and the two adjacent vertebrae surgically fused together. While this treatment alleviates the pain, all discal motion is lost in the fused segment. Ultimately, this procedure places greater stress on the discs adjacent the fused segment as they compensate for the lack of motion, perhaps leading to premature degeneration of those adjacent discs. A more desirable solution entails replacing in part or as a whole the damaged nucleus with a suitable prosthesis having the ability to complement the normal height and motion of the disc while stimulating the natural disc physiology.
The first prostheses embodied a wide variety of ideas, such as ball bearings, springs, metal spikes and other perceived aids. These prosthetic discs were designed to replace the entire intervertebral disc space and were large and rigid. Beyond the questionable efficacy of those devices was the inherent difficulties encountered during implantation. Due to their size and inflexibility, these first generation devices required an anterior implantation approach as the barriers presented by the lamina and, more importantly, the spinal cord and nerve rootlets during posterior implantation, could not be avoided. Recently, smaller and more flexible prosthetic nucleus devices have been developed. With the reduction in prosthesis size, the ability to work around the spinal cord and nerve rootlets during posterior implantation has become possible.
Generally speaking, these reduced size prostheses are intended to serve as a replacement for the natural nucleus. In other words, the anulus and end plates remain intact, and the prosthesis implanted within the nucleus cavity. It is generally believed that this approach facilitates healing of the anulus. Unfortunately, however, inherent design characteristics of these prostheses may in fact damage the anulus. For example, Bao et al., U.S. Pat. No. 5,047,055, discloses a prosthetic nucleus made of a hydrogel material that is implanted into the intradiscal space in a dehydrated state. Following implant, the hydrogel material hydrates and expands without constraint to, at least in theory, a shape conforming to the natural nucleus. Similarly, Bao et al., U.S. Pat. No. 5,192,326, describes a prosthetic nucleus comprised of a solid hydrogel core or of a multiplicity of hydrogel beads surrounded by a membrane. Once again, this prosthesis is implanted into the disc space in a dehydrated state, subsequently hydrating, at least in theory, to a shape conforming to the natural nucleus. The prostheses of Bao, as well as other similar products, rely solely upon the natural anulus to constrain expansion of the hydrogel core. Obviously, this essentially uncontrolled expansion imparts a lateral force directly upon the anulus. In most situations, the anulus is already damaged, and any additional forces placed on the anulus by the prosthesis may impede healing and even cause further deterioration. Further, it is virtually impossible to accurately orientate the dehydrated prostheses of Bao within the nucleus cavity due to the confined environment.
As previously described, an important feature of a prosthetic nucleus is that the anulus is not entirely removed upon implantation. Normally, however, an opening of some type must be created through the anulus. The prosthetic nucleus is then passed through this opening for implantation into the nucleus cavity. Because creation of this opening traumatizes the anulus, it is highly desirable to minimize its size. Unfortunately, however, most prosthetic nucleus devices currently available do not account for this generally accepted implantation technique. For example, a relatively rigid prosthesis configured to approximate a shape of the natural nucleus requires an extremely large opening in the anulus in order for the prosthetic device to xe2x80x9cpassxe2x80x9d into the nucleus cavity. Further, a hydrogel-based prosthesis, such as that described in Bao, minimizes, at least in part, the size of the anulus opening in that the hydrogel prosthesis is implanted in a dehydrated state, thereby having a reduced overall size. However, even in the dehydrated state, the Bao prosthesis still has a shape generally conforming to that of a natural nucleus. As a result, regardless of orientation, a relatively blunt surface is presented to the anulus when attempting to implant. This blunt surface is not conducive to insertion through the anulus opening. In fact, the blunt surface may impede implantation, thereby requiring an enlarged opening in the anulus.
In addition to the above-described concern for minimizing stress on the anulus, anatomical variations of the nucleus cavity should also be considered. Generally speaking, each intradiscal space has a greater transverse diameter (as defined by the anulus) at a posterior side than at an anterior side. Additionally, the intradiscal space varies in height (as defined by the opposing end plates) from posterior side to anterior side. In this regard, each intradiscal space has a relatively unique height configuration. For example, the L3-L4 intradiscal space has a slightly greater height at a central area in comparison to the posterior and anterior sides. The L4-L5 intradiscal space displays a more dramatic increase in central height. Finally, the L5-S1 intradiscal space increases in height from the posterior side to the anterior side. Effectively, each intradiscal space can be generally referred to as having an anterior area. With these dimensional variations in mind, a xe2x80x9cstandardxe2x80x9d or single-sized prosthesis likely will not meet the anatomical needs of each and every intradiscal space. This is especially true for a single, rigid prosthesis design sized to encompass the entire intradiscal space that therefore does not recognize the general distinction between the anterior area and the posterior area. A prosthetic nucleus that fails to account for the anatomical variation in height of the nucleus cavity may also result in an uneven load distribution across the prosthesis and therefore poor spacing performance.
Finally, restoring the nutrition-flushing cycle of a natural disc is important for a prosthetic spinal disc nucleus to be successful. As previously described, most of the nutrition for the inner anulus and nucleus is provided by diffusion through the end plates of the vertebral bodies and by the important pumping action between the partially loaded and fully loaded conditions of the disc. If the nutritional cycle is impeded, a variety of degenerative changes may occur. Nutrition to the inner disc slowly ceases, resulting in intradiscal build-up of acids and autotoxins, and other changes. This is followed by anular fiber and nucleus degeneration, shrinkage of the nucleus, segmental laxity, spur formation, disc space collapse and perhaps spontaneous fusion. Significantly disabling back pain may also develop. Thus, a prosthetic nucleus sized to encompass the entire nucleus cavity prevents the fluid pumping action of the disc space from occurring, and will not result in complete healing.
Degenerated, painfully disabling intraspinal discs are a major economic and social problem for patients, their families, employers and the public at large. Any significant means to correct these conditions without further destruction or fusion of the disc may therefore serve an important role. Other means to replace the function of a degenerated disc have major problems such as complex surgical procedures, unproven efficacy, placing unnecessary and possibly destructive forces on an already damaged anulus, etc. Therefore, a substantial need exists for a prosthetic spinal disc nucleus formed to facilitate implantation through an anulus opening while providing necessary intradiscal support following implant.
The present invention provides an elongated prosthetic spinal disc nucleus for implantation within a nucleus cavity defined by opposing end plates and an anulus, and a method of manufacturing such a prosthesis. In one preferred embodiment, the prosthesis is comprised of a formed hydrogel core surrounded by a constraining jacket.
The hydrogel core is configured to expand from a dehydrated state to a hydrated state. In this regard, the hydrogel core has a dehydrated shape in the dehydrated state and a hydrated shape in the hydrated state. The dehydrated shape is configured to facilitate insertion of the prosthetic spinal disc nucleus through an opening in the anulus. Further, the dehydrated shape is generally different from the hydrated shape, which in one preferred embodiment relates to size characteristics of the nucleus cavity.
The constraining jacket surrounds the hydrogel core and constrains expansion upon hydration. The constraining jacket is preferably flexible but substantially inelastic. Further, in one preferred embodiment, the constraining jacket has a generally fixed maximum volume that is less than the volume of the nucleus cavity.
The method of manufacturing a prosthetic spinal disc nucleus in accordance with the present invention includes providing a hydrogel material that expands from a dehydrated state to a hydrated state. The hydrogel material is then formed into a hydrogel core having a first shape in the hydrated state. The hydrogel core is inserted into a constraining jacket and reshaped to have a second shape in the dehydrated state, the second shape being different from the first shape. In this regard, the hydrogel core is configured to transition from the second shape to the first shape upon hydration. In one preferred embodiment, reshaping the hydrogel core to have a second shape in the dehydrated state includes forcing the hydrogel core to an elongated shape defined by a leading end, a trailing end and a central portion, the hydrogel core tapering from the central portion to the leading end. This taper facilitates insertion of the leading end of the hydrogel core, otherwise encompassed by the constraining jacket, through an opening in the anulus.
The prosthetic spinal disc nucleus is implanted into the nucleus cavity with the hydrogel core in a dehydrated state. In one preferred embodiment, in the dehydrated state, the hydrogel core has a tapered leading end to facilitate insertion through an opening in the anulus. Once inserted, the prosthetic spinal disc nucleus is preferably transversely orientated within the nucleus cavity, and the hydrogel core is allowed to hydrate. During hydration, the hydrogel core transitions from the dehydrated shape to a predetermined hydrated shape. The hydrated shape preferably conforms with a general anatomical spacing of the particular disc space. For example, in one preferred embodiment, the hydrogel core is wedge shaped in the hydrated state, having a variable height corresponding generally to a shape of the nucleus cavity.
Another aspect of the present invention relates to a prosthetic spinal disc nucleus for implantation into a nucleus cavity of a spinal disc. The nucleus cavity has a height defined by an opposing pair of end plates and an outer periphery defined by an anulus. The prosthetic spinal disc nucleus comprises a formed hydrogel core surrounded by a constraining jacket. The formed hydrogel core is configured to expand from a dehydrated state to a hydrated state. The hydrogel core has a streamlined shape in the dehydrated state and a generally wedge shape in the hydrated state. Further, the hydrogel core is configured to transition from the streamlined shape to the wedge shape upon hydration. The constraining jacket is flexible but substantially inelastic, having a generally fixed maximum volume that is less than a volume of the nucleus cavity. With this configuration, the constraining jacket allows the hydrogel core to transition from the streamlined shape to the wedge shape upon hydration. However, the constraining jacket limits expansion of the hydrogel core in the hydrated state.
USPTO Backgrounds
USPTO Backgrounds