FIELD OF THE INVENTION The present invention relates generally to a prosthesis or artificial body member that is implantable in a spinal column.
BACKGROUND OF THE INVENTION Spinal nerve injuries can be the result of many things including torn, ruptured, prolapsed, or herniated intervertebral disks. These injuries occur when disks are damaged so that disk material (the nucleus pulposus) extrudes through the annulus fibrosis and compresses spinal nerves. For younger individuals, disk herniation can occur when lifting a heavy load whereas sneezing can cause disk herniation in the elderly. Regardless of cause, disk herniation is usually painful.
Common symptoms of disk herniation can include: a stiff neck, back aches, muscle spasms, pain while coughing or straining, and sensory disturbances in the arms, hands, legs and feet. Most disk herniation is treated conservatively, at least initially.
Conservative treatment consists of strict bed rest on a firm mattress and the use of drugs. Local heat applications are also employed, but prolonged heat applications increase the likelihood of congestion. Corsets can provide additional support for an individual with a lumbar disk problem.
When the conservative approach is ineffective, surgery may be required. Surgical treatment of a herniated intervertebral disk often involves the removal of all, or a portion, of the nucleus pulposus of an intervertebral disk. Currently, no reconstruction of an intervertebral disk is performed thereby allowing rapid degeneration of the disk. This invention allows reconstruction of the disk using an implant. For an effective treatment, however, an implant must be firmly anchored in place. Unfortunately, known implants have a tendency to shift around like the damaged intervertebral disks that they replace, resulting in surgical treatments whose long-term outcomes are not always positive. Implants that employ sutures as an anchor are notorious for their high failure rates. Other implant designs that rely on caps, covers, and tethers attached to the annulus fibrosis are similarly problematic.
SUMMARY OF THE INVENTION In light of the problems associated with the known methods and apparatus for repairing ruptured, prolapsed, or herniated intervertebral disks, it is a principal object of the invention to provide a surgical implant that both replaces the nucleus pulposus of a human intervertebral disk and plugs the annulus fibrosis of the same disk. The means employed to replace the nucleus pulposus and the means employed to plug the annulus fibrosis serve to mutually anchor one another between adjacent vertebrae.
It is another object of the present invention to provide a surgical implant of the type described that can be easily embedded within the body of a patient with conventional surgical tools after a limited period of instruction.
It is an object of the invention to provide improved features and arrangements thereof in a surgical implant for the purposes described that is uncomplicated in construction, inexpensive to manufacture, and fully dependable in use.
Briefly, the surgical implant in accordance with this invention achieves the intended objects by featuring an inflatable bladder and an externally threaded inlet port connected to the inflatable bladder. The inlet port has a threaded bore through which a self-hardening, polymeric filler is admitted into the bladder to permanently inflate it. A setscrew is screwed into the threaded bore for plugging the threaded bore to retain the filler within the bladder.
The surgical implant constructed in accordance with the invention also features an inlet port having an “hourglass” shape with a peripheral groove near its midpoint for receiving the raised marginal edges of adjacent vertebrae to prevent the migration of the inlet port and the remainder of the implant of which the inlet port is a part. Furthermore, once positioned between adjacent vertebrae, the inlet port acts as a plug in the annulus fibrosis.
Additionally, the surgical implant features an inflatable bladder packed with a polymeric filler that assumes the shape of an intervertebral void to anchor the inlet port for the inflatable bladder located between adjacent vertebrae.
Furthermore, the surgical implant features an inlet port made of an elastomeric material and having a threaded bore therein for the passage of polymeric filler into the inflatable bladder. The threaded bore is plugged by an oversized, tapered setscrew that expands the inlet port to lock such tightly between adjacent vertebrae.
The foregoing and other objects, features and advantages of the present invention will become readily apparent upon further review of the following detailed description of the preferred embodiments as illustrated in the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS The present invention may be more readily described with reference to the accompanying drawings, in which:
FIG. 1 is a side view of a surgical implant in accordance with the present invention with portions broken away to reveal details thereof.
FIG. 2 is a longitudinal cross-sectional view of the inlet port of the surgical implant ofFIG. 1 with a syringe inserted therein.
FIG. 3 is a longitudinal cross-sectional view of the inlet port with a setscrew being inserted therein.
FIG. 4 is a schematic cross-sectional showing forceps being employed to remove the nucleus pulposus of an intervertebral disk.
FIG. 5 is a schematic cross-sectional showing the surgical implant, with its inflatable bladder in a collapsed state, positioned by a screwdriver for insertion between adjacent vertebrae.
FIG. 6 is a schematic cross-sectional view showing the surgical implant, with its inflatable bladder in a collapsed state, after being driven between adjacent vertebrae with the upper and lower surfaces of the vertebrae pinching the inlet port of the implant to hold such in place.
FIG. 7 is a schematic cross-sectional view showing the inflatable bladder of the surgical implant, positioned between adjacent vertebrae, being filled with a settable polymer delivered through the inlet port by a syringe.
FIG. 8 is a schematic cross-sectional view showing a setscrew being threaded into the inlet port of the surgical implant, positioned between adjacent vertebrae, by a screwdriver to retain a settable polymer within the inflatable bladder of the implant.
FIG. 9 is a schematic cross-sectional view showing the surgical implant fully deployed between adjacent vertebrae.
FIG. 10 is an exploded side view of an alternative surgical implant in accordance with the present invention with portions broken away to reveal details thereof.
FIG. 11 is a schematic cross-sectional showing the inlet port of the surgical implant ofFIG. 10 being positioned by a screwdriver for insertion between adjacent vertebrae.
FIG. 12 is a schematic cross-sectional view showing the inlet port of the alternative surgical implant pinched between the upper and lower surfaces of adjacent vertebrae with the inflatable bladder of the alternative implant being slid through the inlet port into the evacuated space between the vertebrae.
FIG. 13 is a schematic cross-sectional view showing the locking sleeve of the alternative surgical implant being screwed into the inlet port, pinched between the upper and lower surfaces of adjacent vertebrae, to fasten the inflatable bladder to the inlet port.
FIG. 14 is a schematic cross-sectional view showing the inflatable bladder of the alternative surgical implant, positioned between adjacent vertebrae, being filled with a settable polymer delivered through the inlet port by a syringe.
FIG. 15 is a schematic cross-sectional view showing a setscrew being threaded into the inlet port of the alternative surgical implant, positioned between adjacent vertebrae, by a screwdriver to retain a settable polymer within the inflatable bladder of the implant.
FIG. 16 is a schematic cross-sectional view showing the alternative surgical implant fully deployed between adjacent vertebrae.
Similar reference characters denote corresponding features consistently throughout the accompanying drawings.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the FIGS., a surgical implant in accordance with the present invention is shown at10 inFIGS. 1-9.Implant10 includes aninflatable bladder12 to which is fastened aninlet port14 for the controlled admission of afiller16 intobladder12. Asetscrew18plugs inlet port14 to retainfiller16 withinbladder12. In use,implant10 partially replaces anintervertebral disk20 having anouter annulus fibrosis22 and an inner nucleus pulposus24. Implant10 permits flexible articulation ofadjacent vertebrae26 and28 yet provides an internal resistance to bending that lends stability to a spine.
Inflatable bladder12 includes a material-holding reservoir30 from which atubular spout32 extends.Reservoir30 andspout32 are integrally formed of a plastic material that is lightweight, nonporous, impermeable, and biocompatible but incapable of dissolution within the human body. Similarly, the material is flexible and strong so that it cannot be easily torn or punctured when used.Bladder12 can be formed from any suitable material and made in any suitable manner known in the art.
Reservoir30 is provided with a size and shape that is substantially the same as that ofintervertebral void34 left after excavating the nucleus pulposus24 betweenvertebrae26 and28. When inflated by the addition offiller16 to the interior ofbladder12,reservoir30 completely packsvoid34 and fully engages the surfaces that define the boundaries ofvoid34 such as the layers ofcartilage36 and38 covering the upper and lower surfaces ofvertebrae26 and28 and theannulus fibrosis22. Furthermore,inflated reservoir30 drivesvertebrae26 and28 away from one another and retains such in a spaced-apart condition to lengthen and tighten the fibers ofannulus fibrosis22 resulting in spinal stability.
Filler16 is a biocompatible polymer, delivered to the interior ofbladder12 in a liquid or semi-liquid state, which is capable of gelling within a short period of time. Once solidified, the polymer must stay as a gel for the lifetime of the patient. One suitable polymer is formed by the mixture of bovine serum albumin (BSA) and glutaldehyde that hardens from a liquid to a rubber-like solid within minutes. Of course, other materials can be employed asfiller16 and these can be provided in a suitable manner to the interior ofbladder12 in a solid, liquid, and/or gaseous state.
Inlet port14 is a tube having inner and outer diameters that vary along the length thereof. One end ofinlet port14 is formed as avertebral engagement portion40 with a silhouette resembling that of an hourglass. The other end ofinlet port14 is abladder attachment portion42 with a T-shaped outline.
Vertebral engagement portion40 has ahip44 and ashoulder46 connected together by anarrow waist48. As shown,hip44 is convex with an inwardly slopingsurface50 that cants towardwaist48 and an outwardlysloping surface52 that tilts away fromwaist48 and toward theinner end54 ofvertebral engagement portion40. Inwardly slopingsurface50 flows smoothly intowaist48 that is concave and defines a peripheral groove about the middle ofvertebral engagement portion40.Waist48, in turn, flows smoothly intoshoulder46 that flares outwardly fromwaist48 to terminate at the planarouter end56 ofvertebral engagement portion40.
Helical threads58 are provided around the periphery ofvertebral engagement portion40 extending frominner end54 toouter end56.Threads58 have an even height and width along their lengths and conform closely to the surface contours ofvertebral engagement portion40. Thus,threads58 trace helical paths that increase in diameter over outwardly slopingsurface52 when traveling frominner end54 towardouter end56. Also,threads58 trace helical paths that decrease in diameter over inwardly slopingsurface50 to the middle ofwaist48. From the middle ofwaist48 across toshoulder46, the helical paths ofthreads58 increase in diameter.
Attachment portion42 extends frominner end54 ofvertebral engagement portion40 and is sized for positioning withinspout32 ofbladder12.Attachment portion42 includes acylindrical leg60 from the bottom of which aperipheral flange62 extends outwardly. Aperipheral channel64 is formed betweenperipheral flange62 andinner end54 ofvertebral engagement portion40.
After insertingattachment portion42 ofinlet port14 intospout32 ofbladder12, a lockingring66 is fitted aroundspout32 and overattachment portion42 at a location adjacentperipheral channel64. Since lockingring66 is dimensioned to fit snugly withinperipheral channel64, the release of lockingring66 forces spout32 againstattachment portion42 and strongly fastensinlet port14 tobladder12. Preferably, lockingring66 is formed from a resilient plastic material that permits it to be stretched prior to it being seated inperipheral channel64.
A bore68 extends longitudinally throughinlet port14, passing through bothvertebral engagement portion40 andattachment portion42.Bore68 has aninlet end70 inshoulder46 and a threaded outlet end72 that extends fromwaist48 to flange62, both ends70 and72 taper in diameter. Preferably,inlet end70 is enlarged in terms of diameter so that the taperedhead74 ofsetscrew18 can be countersunk therein.Inlet end70 is also provided with a plurality ofradial slots76 around the perimeter thereof. Thetool end78 of ascrewdriver80 can be positioned withinslots76 for rotatinginlet port14 so as to screw it intointervertebral void34.
Setscrew18 is adapted to be threaded intobore68.Setscrew18 has a taperedhead74 for positioning ininlet end70 ofbore68 and a threadedrod82 extending fromhead74 for positioning within threaded outlet end72 ofbore68.Head74 is provided with a plurality ofradial slots84 that receive tool end78 ofscrewdriver80 when it is desired tothread setscrew18 intobore68. For a snug fit inbore68, bothhead74 and threadedrod82 are tapered likebore68.
Inlet port14 is formed from a resilient plastic material and bore68 is provided with a size that is slightly smaller in terms of diameter than that ofsetscrew18. Thus, whensetscrew18 is threaded intobore68,setscrew18 acts as a wedge to expandinlet port14, increasing its outer diameter to firmly anchor such betweenvertebrae26 and28.
The use ofsurgical implant10 is straightforward. First, through anincision86 inannulus fibrosis22, damagednucleus pulposus24 is removed from betweenvertebrae26 and28 withforceps88 as shown inFIG. 4. Then, as is illustrated inFIG. 5, deflatedbladder12 is inserted into theintervertebral void34 resulting from the removal ofnucleus pulposus24. Simultaneously,inner end54 is placed againstincision86. Now, by positioningtool end78 ofscrewdriver80 intoend70 ofbore68 and intoslots76, with continued reference toFIG. 5,inlet port14 is ready to be screwed intovoid34.
Threads58 onintervertebral engagement portion40 facilitate the entry ofinlet port14 intovoid34. Asscrewdriver80 is turned, the portion ofthreads58 adjacent outwardly slopingsurface52 serve to leadinlet port14 throughincision86, grip and spreadvertebrae26 and28, and pullinlet port14 forward intovoid34. The portion ofthreads58 adjacent inwardly slopingsurface50,waist48, andshoulder46, aid in settingwaist48 comfortably between raisedmarginal edges90 and92 ofvertebrae26 and28 as shown inFIG. 6. Thethreads58adjacent waist48 “bite” intomarginal edges90 and92 to securely anchorinlet port14 in place with flaredshoulder46 effectively pluggingincision86.
Onceinlet port14 is positioned betweenvertebrae26 and28,bladder12 is inflated. To do this, thenozzle94 of asyringe96, filled with a liquid orsemi-liquid polymer filler16, is inserted intobore68 as shown inFIGS. 2 and 7. Preferably,nozzle94 is provided with a taper like that ofbore68 so that upon insertion, a good seal is provided to prevent leakage offiller16. Then,plunger98 ofsyringe96 is depressed to drive a predetermined volume offiller16 intobladder12. The pressure applied to plunger98 and ultimately tofiller16 is largely a matter of trial and error but must be sufficient to expandreservoir30 so that it packsintervertebral void34 and holdsvertebrae26 and28 in a spaced-apart condition to lengthen and tighten the fibers ofannulus fibrosis22.
Afterpolymeric filler16 has changed state from a liquid or semi-liquid to a rubber-like solid (a few minutes),nozzle94 is withdrawn frombore68 and is replaced bysetscrew18.FIG. 8 illustratesscrewdriver80 engaged withhead74 ofsetscrew18 and threadingsetscrew18 intobore68. Becausesetscrew18 is somewhat larger than bore68 andinlet port14 is formed of a resilient material, fully threadingsetscrew18 intobore68 in accordance withFIG. 9 slightly enlarges the diameter ofinlet port14 to lock such in place betweenvertebrae26 and28. Finally, after a brief period of convalescence, the patient receivingsurgical implant10 should find his spine to be pain free with nearly full mobility restored.
An alternative surgical implant in accordance with the present invention is shown at110 inFIGS. 10-16.Implant110 includes aninflatable bladder112 to which is fastened aninlet port114 for the controlled admission of afiller116, identical tofiller16 described above, intobladder112. Asetscrew118 plugsinlet port114 to retainfiller116 withinbladder112.
Inflatable bladder112 includes a material-holdingreservoir130 from which atubular spout132 extends.Reservoir130 and spout132 are integrally formed from the same materials and same manner asreservoir30 and spout32 ofbladder12.Reservoir130 is provided with a size and shape that is substantially the same as that ofintervertebral void134 left after excavating the nucleus pulposus from between a pair ofadjacent vertebrae126 and128 as shown inFIG. 11. When inflated by the addition offiller116 to the interior ofbladder112,reservoir130 packs void134 and fully engages the surfaces that define the boundaries ofvoid134. Furthermore,inflated reservoir130forces vertebrae126 and128 apart and retains such in a spaced-apart condition to lengthen and tighten the fibers of annulus fibrosis122.
Inflatable bladder112 further comprises anattachment portion142 that is inserted withinspout132 and alocking ring166 that is fitted overspout132.Attachment portion142 includes acylindrical leg160 from the top and middle of whichperipheral flanges162aand162bextend outwardly. Aperipheral channel164 is formed betweenperipheral flanges162aand162b.After insertingattachment portion142 intospout132, lockingring166 is moved overspout132 andattachment portion142 to a location adjacentperipheral channel164. Since lockingring166 is dimensioned to fit snugly withinperipheral channel164, the release of lockingring166 forces spout132 againstattachment portion142 and strongly fastensattachment portion142 tobladder112.
Inlet port114 includes avertebral engagement portion140 having atubular sleeve141 with a silhouette resembling that of an hourglass and atubular insert143 for positioning withinsleeve141.Sleeve141 has ahip144 and ashoulder146 connected together by anarrow waist148.Hip144 is convex with an inwardly slopingsurface150 that cants towardwaist148 and an outwardly sloping surface152 that tilts away fromwaist148 and toward theinner end154 ofsleeve141. Inwardly slopingsurface150 flows smoothly intowaist148 that is concave and defines a peripheral groove about the middle ofsleeve141. Also,waist148 flows smoothly intoshoulder146 that flares outwardly fromwaist148 to terminate at the planarouter end156 ofsleeve141.
Helical threads158 are provided around the periphery ofsleeve141 extending betweenends154 and156.Threads158 have an even height and width along their lengths and conform closely to the surface contours ofsleeve141.Threads158, therefore, trace helical paths that increase in diameter over outwardly sloping surface152 when moving fromend154 towardend156. Additionally,threads158 trace helical paths that decrease in diameter over inwardly slopingsurface150 to the middle ofwaist148. From the middle ofwaist148 toshoulder146 the helical paths ofthreads158 increase in diameter.
A threadedbore145 extends longitudinally throughtubular sleeve141 and is sized to receiveattachment portion142 ofbladder112 andtubular insert143.Sleeve141 is provided with aperipheral lip147 atinner end154 that projects inwardly intobore145.Lip147 serves as an abutment surface forattachment portion142 and a stop to prevent the full passage of bothattachment portion142 and insert143 throughsleeve141.
Tubular insert143 has helical threads149 on its exterior so that it can be screwed into threadedbore145 intubular sleeve141. A threadedbore168 also extends longitudinally throughtubular insert143 so thatsetscrew118 can be screwed into it.Bore168 has aninlet end170 for positioningadjacent shoulder146 and a threadedoutlet end172 for positioningadjacent waist148, both ends170 and172 tapering in diameter. Preferably,inlet end170 is enlarged so that the taperedhead174 ofsetscrew118 can be countersunk within it.Inlet end170 is also provided with a plurality ofradial slots176 around its perimeter. Thetool end178 of ascrewdriver180 can be positioned withinslots176 for rotatinginsert143 so as to screw it intosleeve141. Continued rotation ofscrewdriver180, onceinsert143 is fully screwed intosleeve141, imparts rotational motion tosleeve141 to screwinlet port114 intointervertebral void134.
Setscrew118 is threaded intobore168 intubular insert143.Setscrew118 has ahead174 for positioning ininlet end170 ofbore168 and a threadedrod182 extending fromhead174 for positioning within threadedoutlet end172 ofbore168.Head174 is provided with a plurality ofradial slots184 that receive thetool end178 ofscrewdriver180 when it is desired tothread setscrew118 intobore168. For a snug fit withinbore168,head174 and threadedrod182 are provided with tapers similar to that ofbore168.
Tubular sleeve141 andtubular insert143 are formed from a resilient plastic material and bore168 is provided with a size that is slightly smaller in terms of diameter than that ofsetscrew118. Thus, whensetscrew118 is threaded intobore168,setscrew118 acts as a wedge to expandinsert143 andsleeve141, increasing the outer diameter ofinlet port114 to firmly anchor such betweenvertebrae126 and128.
The use of alternativesurgical implant110 is as straightforward as the use ofsurgical implant10. First, through anincision186 in annulus fibrosis122, damaged nucleus pulposus is removed from betweenvertebrae126 and128 with forceps as shown inFIG. 4 to formintervertebral void134. Then, as illustrated inFIG. 11,inner end154 ofsleeve141 is placed againstincision186 by means ofscrewdriver181 whosetool end183 is inserted withinradial slots151 provided inouter end156 ofsleeve141 about threadedbore145. Now, by apply a light pressure toscrewdriver181 and by rotatingscrewdriver181,sleeve141 is screwed betweenvertebrae126 and128 intovoid134 at the location shown inFIG. 12.
Threads158 onsleeve141 facilitate the entry ofsleeve141 intovoid134. Asscrewdriver181 is turned, the portion ofthreads158 adjacent outwardly sloping surface152 serve to:lead sleeve141 throughincision186, grip and spreadvertebrae126 and128, and pullsleeve141 forward intovoid134. The portions ofthreads158 adjacent inwardly slopingsurface150,waist148, andshoulder146, aid in settingwaist148 comfortably between raisedmarginal edges190 and192 ofvertebrae126 and128 as shown inFIG. 12. Thethreads158adjacent waist148 “bite” intomarginal edges190 and192 ofvertebrae126 and128 to securely anchorsleeve141 in place withshoulder146 effectively pluggingincision186.
Oncesleeve141 is positioned betweenvertebrae126 and128,bladder112 is affixed tosleeve141. To do this arod153 is inserted throughattachment portion142 intoreservoir130 as shown inFIG. 12, androd153, withbladder112 positioned thereon, is extended throughbore145 insleeve141 intovoid134. Then, whenattachment portion142 is engageslip147,rod153 is withdrawn frombore145 leavingbladder112 in place invoid134. Next, as illustrated inFIG. 13,tubular insert143 is threaded intobore145 by positioningtool end178 ofscrewdriver180 inslots176 androtating screwdriver180. When insert143 presses againstattachment portion142 rotation ofscrewdriver180 is stopped andscrewdriver180 is withdrawn fromslots176.Bladder112 andinlet port114 cannot now be easily separated.
Bladder112 is inflated by pressing thenozzle194 of asyringe196, filled with a liquid orsemi-liquid polymer filler116, intobore168 ininsert143 as shown inFIG. 14.Nozzle194 is tapered likebore168 so that upon insertion intobore168, a good seal is provided. Then,plunger198 ofsyringe196 is depressed to drivepolymeric filler116 intobladder112 to expandreservoir130 so that it packsintervertebral void134 and holdsvertebrae126 and128 in a spaced-apart condition.
Afterfiller116 has hardened,nozzle194 is withdrawn frombore168 and is replaced bysetscrew118 as shown inFIG. 15. Here, thetool end178 ofscrewdriver180 is positioned withinslots184 insetscrew118 and is rotated tothread setscrew118 intobore168. Becausesetscrew118 is somewhat larger thanbore168 andsleeve141 and insert143 are formed of a resilient material, fully threadingsetscrew118 intobore168 in accord withFIG. 16 increases the diameter ofinlet port114 to lockinlet port114 betweenvertebrae126 and128. After convalescing, the patient should find that he is pain free and his spine has a full range of flexible articulation.
Whilesurgical implants10 and110 have been described with a high degree of particularity, it will be appreciated by those skilled in the art that modifications can be made to them. Thus, it is to be understood that the present invention is not limited to the implant embodiments described above, but encompasses any and all embodiments within the scope of the following claims.