US20110098746A1 - Methods and Apparatus For Treating Spinal Stenosis - Google Patents

Abstract

This invention relates generally to spine surgery and, in particular, to methods and apparatus for treating spinal stenosis with a spinous process spacer and an overlay designed to extend between the superior and inferior spinous processes in order to restore the integrity and functional benefits of the supraspinous ligament.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• This application is a continuation of U.S. patent application Ser. No. 11/635,698 filed Dec. 6, 2006, now U.S. Pat. No. 7,862,592 which claims the benefit under 35 U.S.C. §119(e) to U.S. Provisional Application Ser. No. 60/748,107 filed Dec. 6, 2005, the entire contents of which are hereby expressly incorporated by reference into this disclosure as if set forth fully herein.
BACKGROUND OF THE INVENTION
• I. Field of the Invention
• This invention relates generally to spine surgery and, in particular, to methods and apparatus for treating spinal stenosis.
• II. Discussion of the Prior Art
• Spinal stenosis is a narrowing of spaces in the spine which results in pressure on the spinal cord and/or nerve roots. This disorder usually involves the narrowing of one or more of the following: (1) the canal in the center of the vertebral column through which the spinal cord and nerve roots run, (2) the canals at the base or roots of nerves branching out from the spinal cord, or (3) the openings between vertebrae through which nerves leave the spine and go to other parts of the body.
• Pressure on the lower part of the spinal cord, or on nerve roots branching out from that area, may give rise to pain or numbness in the legs. Pressure on the upper part of the spinal cord (neck area) may produce similar symptoms in the shoulders, or even the legs. The condition generally occurs in patients who are in their last decade or decades of life.
• Laminectomy, which involves removing bone, the lamina, from the vertebrae, is the most common surgical treatment for spinal stenosis. Laminectomy enlarges the spinal canal, thus relieving the pressure on compressed nerves. Surgical burs, drills, punches, and chisels are used during the procedure.
• Surgeons risk injuring the nerves or the spinal cord as they enlarge the spinal canal. In addition, elderly patients frequently have co-morbidities that increase the risk of laminectomy.
• Complications of laminectomy include increased back pain, infection, nerve injury, blood clots, paralysis, prolonged recovery, and death.
• Lumbar fusion is frequently preformed in conjunction with laminectomy. Current fusion techniques require abrasion of large surfaces of bone. Bone bleeds during and after abrasion. Current fusion techniques increase the risk of spinal stenosis procedures. Fusion also prolongs patient recovery following spinal stenosis surgery. Furthermore, various fusion techniques require the severing and/or removal of certain soft tissue surrounding the spine, including but not limited to the supraspinous ligament, the intraspinous ligament, the ligamentum flavum, the posterior longitudinal ligament, and/or the anterior longitudinal ligament.
• Increasingly, surgeons are looking for improved methods of effecting less invasive treatments for spinal stenosis. The device must be able to be safely and consistently implanted without excess damage to the patient. The present invention is directed at overcoming, or at least improving upon, the disadvantages of the prior art.
SUMMARY OF THE INVENTION
• This invention is directed to a surgical apparatus for treating spinal stenosis without the need for a laminectomy. Broadly, the invention resides in an apparatus configured for placement in an intraspinous space, (e.g. posteriorly to a spinal canal between a first spinous process and an adjacent second spinous process). In the preferred embodiment, the device permits spinal flexion while limiting spinal extension, thereby providing an effective treatment for treating spinal stenosis. The invention may be used in the cervical, thoracic, or lumbar spine.
• The preferred embodiments teach a spinal apparatus configured for placement between adjacent vertebrae and adapted to fuse to a first spinous process. Various mechanisms, including shape, porosity, tethers, and bone-growth promoting substances may be used to enhance fusion. The tether may be a wire, cable, suture, allograft tissue, or other single or multi-filament member. Preferably, the device forms a pseudo-joint in conjunction with the non-fused vertebra.
• The spinous process spacer of the present invention may be of bone or non-bone construction. In the bone embodiments, the spinous process spacer may be constructed from any suitable allograft, including but not limited to portions of clavicle, rib, humerus, radius, ulna, metacarpal, phalanx, femur, tibia, fibula, or metatarsal bone. In non-bone embodiments, the spinous process spacer may be any suitable construction, including but not limited to polyaryletherketone (PEEK) and/or polyaryletherketoneketone (PEKK). In either event, the spacer includes a slot or indent to receive a portion of a spinous process to enhance fusion. The device may contain one or more bone-growth promoting substances such as BMP1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 . . . n, demineralized bone matrix, allograft cancellous bone, autograft bone, hydroxyapatite, coral and/or other highly porous substance.
• During insertion of the spinous process spacer of the present invention, it may become necessary to sever the supraspinous and interspinous ligaments. In such instances it may be desirable to include an overlay designed to extend from one of the first and second spinous processes to the other in order to restore the integrity and functional benefits of the supraspinous and/or intraspinous ligaments.
BRIEF DESCRIPTION OF THE DRAWINGS
• Many advantages of the present invention will be apparent to those skilled in the art with a reading of this specification in conjunction with the attached drawings, wherein like reference numerals are applied to like elements and wherein:
• FIG. 1 is a side view of the spinous processes of a pair of adjacent vertebrae with a spinous process spacer according to one embodiment of the present invention inserted therebetween, illustrating in particular the spinous process spacer tethered to one spinous process during use;
• FIG. 2 is a perspective view of the spinal process spacer assembly ofFIG. 1 including bone growth promoting material;
• FIG. 3 is a perspective view of a spinous process spacer according to one embodiment of the present invention;
• FIG. 4 is a side plan view of the spinous process spacer ofFIG. 3;
• FIG. 5 is a front plan view of the spinous process spacer ofFIG. 3;
• FIG. 6 is a top plan view of the spinous process spacer ofFIG. 3;
• FIG. 7 is a front cross section view of the spacer ofFIG. 3;
• FIG. 8 is a perspective view of a spinous process spacer according to an alternative embodiment of the present invention;
• FIG. 9 is a side view of the spinous process spacer ofFIG. 8;
• FIG. 10 is an end view of the spinous process spacer ofFIG. 8;
• FIG. 11 is a side view of the spinous processes of a pair of adjacent vertebrae with a spinous process spacer according to one embodiment of the present invention inserted therebetween, illustrating the spinous process spacer thethered to one spinous process during use and further illustrating the disruption of the supraspinous ligament and the intraspinous ligament during insertion;
• FIG. 12 is a side view of the affixed spinous process spacer ofFIG. 11, illustrating the further use of an overlay spanning from one spinous process to the other, primarily covering the distal portions of the spinous processes; and
• FIG. 13 is a side view of the affixed spinous process spacer ofFIG. 11, illustrating the further use of an overlay spanning from one spinous process to the other and covering a significant portion of the spinous processes.
DESCRIPTION OF THE PREFERRED EMBODIMENT
• Illustrative embodiments of the invention are described below. In the interest of clarity, not all features of an actual implementation are described in this specification. It will of course be appreciated that in the development of any such actual embodiment, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure. The spinal alignment system disclosed herein boasts a variety of inventive features and components that warrant patent protection, both individually and in combination.
• FIG. 1 illustrates a perspective view of a spinous process spacer (“SPS”)assembly10 of the present invention in use between the spinous processes of a pair of adjacent vertebrae in a human spine. TheSPS assembly10 includes aspacer12, aprimary tether14, and two side tethers15 (only one of which is shown inFIG. 1). Thespacer12, as illustrated inFIGS. 4-8, is generally cylindrical and includes amain chamber16, a pair ofinsertion tool apertures18, afusion notch20, and a pair oftether lumens22. As will be described in greater detail below, according to a preferred embodiment thespacer12 is coupled to only one spinous process (e.g. the superiorspinous process2 as shown inFIG. 1). This is accomplished, by way of example only, by securing theprimary tether14 to the superior spinous process2 (as a first step of affixation), and then using a pair of side tethers15 to affixspacer12 to theprimary tether14. This step may be accomplished, by way of example only, by passing oneside tether15 through each of thetether lumens22, further passing theside tether15 between the superiorspinous process2 and theprimary tether14, and finally tightening eachside tether15 until thespacer12 is generally transverse to the longitudinal axis of the spine.
• Thespacer12 may be of bone or non-bone construction. The bone embodiment involves manufacturing thespacer12 from a suitable allograft, including but not limited to clavicle, rib, humerus, radius, ulna, metacarpal, phalanx, femur, tibia, fibula, or metatarsal bone. The non-bone embodiment involves manufacturing thespacer12 from suitable non-bone materials, including but not limited to polyaryletherketone (PEEK) and polyaryletherketoneketone (PEKK). In either event, thespacer12 is designed to fuse to the superiorspinous process2 over time, resulting in what is called “hemi-fusion” in that thespacer12 will be fused to only one spinous process. This may be augmented by disposing any number of suitable fusion-inducingmaterials17 within the spacer12 (as shown by way of example only inFIG. 2), including but not limited to BMP1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 . . . n, demineralized bone matrix, allograft cancellous bone, autograft bone, hydroxyapatite, coral and/or other highly porous substance.
• Although shown and described with regard to the superiorspinous process2, it will be appreciated that thespacer12 may also be coupled to only the inferiorspinous process4 without departing from the scope of the present invention. Thespacer12, once positioned, serves to distract the interspinous process space, which advantageously restores foraminal height in stenotic patients and may also indirectly decompress the intervertebral space.
• As depicted inFIGS. 3-4, themain chamber16 extends through the lateral sides of thespacer12. Themain chamber16 may be provided in any of a variety of suitable shapes in addition to the generally cylindrical shape as shown, including but not limited to a generally oblong, triangular, rectangular shape and/or combinations thereof. The pair ofinsertion tool apertures18 may be located on either the posterior or anterior side of thespacer12 and extend a portion of the way through thespacer12. Thefusion notch20 includes a slot or indent to receive a portion of the superior spinous process2 (or other vertebral structure) to enhance fusion. Thefusion notch20 may be located generally towards the middle portion of the top of thespacer12. Thenotch20 helps center thespacer12 relative to the superior spinous process.
• As best shown inFIG. 7, thetether lumens22 each extend at an angle through the top surface of thespacer12 and into themain chamber16. Eachtether lumen22 may be provided in any of a variety of suitable shapes in addition to the cylindrical shape shown, including but not limited to oblong, triangular, rectangular and/or any combination thereof. Theprimary tether14 and the side tethers15 may comprise any number of suitable materials and configurations, including but not limited to wire, cable, suture thread (permanent and/or bioresorbable), allograft tissue and/or other single or multi-filament member. Suture thread may include any number of components capable of attaching to a spinous process, including but not limited to ordinary suture threads known to and used by those skilled in the art of wound closure. Thetethers14,15 may be of any length necessary to effectively fuse thespacer12 to the particular spinous process.
• According to an alternative embodiment of the present invention shown inFIGS. 8-10, thespacer12 may be provided with asecond notch21 opposite thefusion notch20. Thesecond notch21 is capable of resting on the inferiorspinous process4 during use, which may assist in maintaining thespacer12 in a fully centered position relative to the inferiorspinous process4. As best shown inFIG. 8, thefusion notch20 may be further provided withslots23 extending into themain chamber16. When thespacer12 is coupled to the superiorspinous process2, theseslots23 will establish direct communication between the fusion-inducing compounds provided within themain chamber16 and the lower aspect of the superiorspinous process2, which advantageously augments the ability of thespacer12 to fuse to the superior spinous process2 (particularly if thespacer12 is constructed of non-bone materials).
• During insertion of the spinous process spacer of the present invention, it may become necessary to sever the supraspinous and interspinous ligaments.FIG. 11 illustrates aSPS assembly10 attached to a superiorspinous process2 as described above.Supraspinous ligament6 is illustrated having been severed during the insertion process.Intraspinous ligaments7,9 remain intact, while intraspinous ligament8 (situated between superiorspinous process2 and inferior spinous process4) is also severed.
• FIG. 12 illustrates an alternative embodiment of the present invention, in which theSPS assembly10 may further include anoverlay30 designed to extend between the superior and inferiorspinous processes2,4 in order to restore the integrity and functional benefits of thesupraspinous ligament6. By way of example only,overlay30 may be any material suitable for restoring the structural and functional integrity of thesupraspinous ligament6, including but not limited to a surgical mesh, textile, and/or embroidery. Exemplary textiles are shown and described in commonly owned U.S. Pat. No. 5,990,378 entitled “Textile Surgical Implants Anchors,” which is attached hereto as Exhibit A forming part of this disclosure, and commonly owned US Patent Application Publication No. 2004/0078089 entitled “Textile Prosthesis,” which is attached hereto as Exhibit B forming part of this disclosure.Anchors32 may be used to secure theoverlay30 to thespinous processes2,4. Preferably, anchors32 are inserted into the distal portion of thespinous processes2,4, however it is contemplated that anchors32 may be inserted into any portion of the spinous process suitable to provide purchase. Optionally, side anchors34 may be inserted into the side of thespinous processes2,4 to further secure theoverlay30 to the bone.Anchors32 and side anchors34 may be any device suitable for attaching theoverlay30 to the bone, including but not limited to pins, screws, nails, tacks, staples, and the like.
• FIG. 13 illustrates a still further alternative embodiment of the present invention, in which theSPS assembly10 may further include anoverlay36 designed to extend between the superior and inferiorspinous processes2,4 in order to restore the integrity and functional benefits of thesupraspinous ligament6 and theintraspinous ligament8. By way of example only,overlay36 may be any material suitable for restoring the structural and functional integrity of thesupraspinous ligament6, including but not limited to a surgical mesh, textiles, and/or embroidery (including the exemplary textiles referenced above).Anchors38 may be used to secure theoverlay30 to thespinous processes2,4. Preferably, anchors38 are inserted into the distal portion of thespinous process spacers2,4, however it is contemplated that anchors38 may be inserted into any portion of the spinous process suitable to provide purchase. Optionally, side anchors40 may be inserted into the side of thespinous processes2,4 to further secure theoverlay36 to the bone.Anchors38 and side anchors40 may be any device suitable for attaching theoverlay36 to the bone, including but not limited to pins, screws, nails, tacks, staples, and the like.
• Although shown as separate components, it is contemplated that overlays30,36 may be integrally formed withspacer12 such that the overlay and spacer are inserted contemporaneously.
• Thespacer12 according to the present invention may be constructed of allograft bone and formed in a generally cylindrical shape. Thespacer12 of the present invention may be provided in any number of suitable shapes and sizes depending upon a particular patient and the shape and strength characteristics given the variation from cadaver to cadaver. Thespacer12 may be dimensioned for use in the cervical and/or lumbar spine without departing from the scope of the present invention. Thespacer12 may be dimensioned, by way of example only, having a length ranging between 6-20 mm and a height ranging between 20-25 mm.
• TheSPS assembly10 of the present invention may be introduced into a spinal target site through the use of any of a variety of suitable instruments having the capability to releasably engage thespacer12. In a preferred embodiment, the insertion tool permits quick, direct, accurate placement of thespacer12 between an upper and lower spinous process. An exemplary insertion tool is shown and described in commonly owned U.S. Pat. No. 6,923,814 entitled “System and Method for Cervical Fusion,” which is attached hereto as Exhibit C forming part of this disclosure.
• In order to use theSPS assembly10 of the present invention in a treatment of spinal stenosis, a clinician must first designate theappropriate spacer size12. A clinician can utilize theSPS assembly10 in either an open or minimally invasive spinal fusion procedure. In either type of procedure, a working channel would be created in a patient that reaches a targeted spinal level. After the creation of the working channel, the interspinous space would be prepared. After preparation a sizer instrument is used to determine the appropriate size of thespacer12. Then thespacer12 is positioned and inserted into the prepared space between the spinous processes. The device forces the spinous processes apart. The spine flexes as the spinous processes are forced apart. The neuroforamina and the spinal canal are enlarged as the spine is flexed. TheSPS assembly10 holds the vertebrae in a flexed position. By way of example only, theSPS assembly10 may be made from an allograft shaft of a long bone such as the humerus, tibia, fibula, radius, ulna, or femur.
• Preparation of the inter spinous process space includes perforating the interspinous ligament between the superior and inferior spinous processes. The supraspinous ligament may be either severed or left intact and distracted out of the way if necessary. A key part of the preparation includes abrading the inferior portion of the superior spinous process where it will communicate with thefusion inducing materials32 packed in themain chamber16. Abrading removes the hard cortical bone from the inferior surface of the superior spinous process and leaves bleeding bone which is better adapted for fusion. As new bone generates to heal the abraded portion it may grow into themain chamber16, fixingspacer12 to the superior spinous process. In the event that the supraspinous ligament has been severed, it may be desirable to secure anoverlay36 to the superior and inferior spinous processes as described above.
• When constructed from allograft, thespacer12 may be manufactured according to the following exemplary method. If necessary, first use a belt sander to reduce any high spots or imperfections to standardize the shape of the bone. Cut the allograft bone to length using the band saw. Remove the cancellous material from the inner canal to create themain chamber16. Using calipers, measure the struts and create a size distribution ofspacers12. Machine theinsertion tool apertures18. Set-up a standard vice for holding the implant across its width on the mill. Use a 3/32″ ball end mill to create the insertion tool apertures18 (same as cervical allograft implant). Insert thespacer12 into the vice and tighten. Calculate the centerline of the20 or 25 mmlong spacer12. Create the holes 2.26 mm away from each side of the centerline (4.52 mm hole to hole distance). Create anotch22 for the spinous process. Set-up the cervical allograft holding fixture that uses theinsertion tool apertures18 and vice to hold thespacer12 across its width on the mill. Use a ¼″ flat end mill to create thenotch22. Calculate the centerline of the 20 or 25 mmlong spacer12. Insert thespacer12 onto the fixture using theinsertion tool apertures18 and tighten the vice. This automatically verifies the correct sizing/spacing of theinsertion tool apertures18. Measure thespacer12 height. Calculate the cut depth to create the desiredspacer12 size. Cut the flat on thespacer12 to the desired depth. Remeasure thespacer12 to insure proper cut depth. Drill theangled lumens22 in face ofspacer12. Remove thespacer12 from the cervical allograft fixture and tighten into the standard vice. Using a battery powered or corded drill with a 1/16″ drill bit, drill through the front face to the canal on both sides. Belt sand the face if needed to create a flat surface for the drill bit to engage thespacer12.
• While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and are herein described in detail. It should be understood, however, that the description herein of specific embodiments is not intended to limit the invention to the particular forms disclosed, but on the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined herein.

Claims (21)

1. A system for treating spinal stenosis, comprising:

an implant dimensioned to fit between a superior spinous process and an inferior spinous process, the implant including a first notch to receive the superior spinous process and a second notch to receive the inferior spinous process to effect fusion between at least one of the first notch and the superior spinous process and the second notch and the inferior spinous process; and

an overlay dimensioned to extend from a distal portion of the first spinous process to a distal portion of the second spinous process to restore the supraspinous ligament.

2. The system ofclaim 1, further comprising a coupling element configured to maintain placement of the implant between the superior spinous process and the inferior spinous process;

3. The system ofclaim 1, wherein the implant is made of at least one of a bone material and a non-bone material.

4. The system ofclaim 3, wherein the non-bone material is at least one of polyetheretherketone and polyetherketoneketone.

5. The system ofclaim 1, wherein the overlay comprises at least one of surgical mesh, textile and embroidery.

6. The system ofclaim 1, further comprising a plurality of anchors to secure the overlay to the superior spinous process and the inferior spinous process.

7. The system ofclaim 6, wherein the anchors include at least one of pins, screws, nails, tacks and staples.

8. The system ofclaim 1, wherein the overlay extends over a portion of the sides of the superior spinous process and over a portion of the sides of the inferior spinous process such that the implant is covered by the overlay.

9. The system ofclaim 1, wherein the overlay is formed as an integral part of the implant.

10. A method for treating spinal stenosis, comprising:

gaining access to an interspinous space between a first spinous process and a second spinous process;

inserting an implant in the interspinous space, the implant dimensioned to fit between the first spinous process and the second spinous process, the implant including a first notch to receive the first spinous process and a second notch to receive the second spinous process to effect fusion between at least one of the first notch and the first spinous process and the second notch and the second spinous process; and

securing an overlay to at least a portion of the first spinous process and at least a portion of the second spinous process such that the overlay extends from a distal portion of the first spinous process to a distal portion of the second spinous process to restore the supraspinous ligament.

11. The method ofclaim 10, wherein the overlay comprises at least one of surgical mesh, textile and embroidery.

12. The method ofclaim 10, wherein securing the overlay comprises introducing at least one anchor into each of the first and second spinous processes and through the overlay.

13. The method ofclaim 12, wherein the anchors include at least one of pins, screws, nails, tacks and staples.

14. The method ofclaim 10, wherein the overlay extends over a portion of the sides of the first spinous process and over a portion of the sides of the second spinous process such that the implant is covered by the overlay.

15. The method ofclaim 10, wherein the overlay is formed as an integral part of the implant.

16. The method ofclaim 10, further comprising abrading a portion of at least one of the first spinous process or second spinous process.

17. The method ofclaim 10, further comprising

applying fusion inducing materials in contact with the implant to effect fusion between the implant and at least one of the first spinous process and the second spinous process

18. The method ofclaim 17, wherein the fusion inducing material includes any of Bone Morphogenic Protein, demineralized bone matrix, allograft cancellous bone, autograft bone, hydroxyapatite and coral.

19. The method ofclaim 10, further comprising

coupling the implant between the first spinous process and the second spinous process with a coupling element to maintain placement of the implant.

20. The method ofclaim 10, wherein the implant is made of at least one of a bone material and a non-bone material.

21. The method ofclaim 20, wherein the non-bone material is at least one of polyetheretherketone and polyetherketoneketone.

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