# Patent

## Title
Methods and instruments for delivering interspinous process spacers

## Abstract

A method for implanting an interspinous process spacer includes deforming a spacer from an extended configuration to a collapsed configuration. The spacer has a first pair of resiliently deformable arms extending from a central section of the spacer and when the spacer is deformed into the collapsed configuration, the first pair of arms moves toward each other. When in the collapsed configuration, the spacer is advanced into a guide tube such that the first pair of arms is constrained only by the guide tube. The guide tube is positioned proximate a pair of adjacent spinous processes and then the spacer is removed from the guide tube so that the first pair of arms resiliently move away from each other and are disposed on a common lateral side of the spinous processes.

## Background
BACKGROUND
Lumbar spinal stenosis (“LSS”, and sometimes called sciatica) is a condition of the spine characterized by a narrowing of the lumbar spinal canal. With spinal stenosis, the spinal canal narrows and pinches the spinal cord and nerves, causing pain in the back and legs. One surgical technique for relieving LSS involves distracting adjacent vertebrae and implanting an interspinous process spacer to maintain the desired separation between the segments. This technique is somewhat less invasive than alternative treatments such as decompressive laminectomy, but may actually provide significant benefits to patients experiencing LSS symptoms. As with other surgeries, one consideration when performing surgery to implant an interspinous spacer is the size of the incision that is required to allow introduction of the device. Interspinous spacers previously known to the art were not easily implanted with minimally invasive surgical techniques. A need exists for instrumentation and methods for implanting an interspinous process spacer using minimally invasive surgical techniques.
SUMMARY
In one embodiment, a system for implanting an interspinous process spacer comprises a deformation instrument adapted to engage a pair of opposing arms of the interspinous process spacer and operable to move the opposing arms relative to one another to deform the interspinous process spacer from an uncollapsed state to a collapsed state. The system further comprises a cannula adapted to receive the collapsed interspinous process spacer from the deformation instrument and direct the interspinous process spacer to an area between a pair of spinous processes.
In another embodiment, a system for minimally invasive implantation of an interspinous process spacer comprises a pair of actuators adapted for insertion between a pair of collapsible arms of the interspinous process spacer and a pivot joint connecting the pair of actuators and adapted to cause the actuators to move apart and to thereby move the collapsible arms from an uncollapsed state to a collapsed state.
In another embodiment, a method comprises selecting an interspinous process spacer having a first pair of opposing arms interconnected by a blocking member. The method further comprises selecting a deformation instrument having a first movable portion and a second movable portion, engaging the first movable portion with one of the opposing arms, and engaging the second movable portion with the other opposing arm. The method further includes moving the first movable portion relative to the second movable portion to move the interspinous process spacer into a collapsed state. The method also includes inserting a first guide tube into a space between a pair of spinous processes and inserting the interspinous process spacer in the collapsed state into the first guide tube.
Additional embodiments are included in the attached drawings and the description provided below.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a sagittal view of a section of a vertebral column.
FIG. 2 is an interspinous process spacer engaged with a spacer deformation instrument according to one embodiment of the present disclosure.
FIG. 3 is an implantation system including the instrument and spacer of FIG. 2.
FIG. 4 is an interspinous process spacer engaged with a spacer deformation instrument according to another embodiment of the present disclosure.
FIG. 5 is an implantation system including the instrument and spacer of FIG. 4.
FIG. 6 is an interspinous process spacer engaged with a spacer deformation instrument according to another embodiment of the present disclosure.
FIG. 7 is an implantation system including the instrument and spacer of FIG. 6.
FIG. 8 is an implantation system according to another embodiment of the present disclosure.
FIG. 9 is an implantation system and interspinous process spacer according to another embodiment of the present disclosure.
FIG. 10 is an implantation system according to another embodiment of the present disclosure.
FIG. 11 is an implantation system according to another embodiment of the present disclosure.
FIG. 12 is an interspinous process spacer according to another embodiment of the present disclosure.
FIG. 13 is a view of the spacer of FIG. 12 after transformation to an uncollapsed state.
FIGS. 14-15 show an interspinous spacer according to another embodiment of the present disclosure.



DETAILED DESCRIPTION
The present disclosure relates generally to vertebral device implantation systems, and more particularly, to systems and procedures for minimally invasive interspinous process spacer implantation. For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments, or examples, illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modifications in the described embodiments, and any further applications of the principles of the invention as described herein are contemplated as would normally occur to one skilled in the art to which the invention relates.
Referring first to FIG. 1, the reference numeral 10 refers to a vertebral joint section or a motion segment of a vertebral column. The joint section 10 includes adjacent vertebral bodies 12, 14. The vertebral bodies 12, 14 include spinous processes 16, 18, respectively. An interspinous process space 20 is located between the spinous processes 16, 18.
Referring now to FIG. 2, an interspinous process spacer 30 is adapted for implantation in the interspinous space 20. The interspinous spacer 30 is designed to maintain a minimal distance between the spinous processes of adjacent vertebrae 12, 14. As such, the spacer 30 has a blocking portion 32 that keeps the vertebrae from coming together. The spacer 30 may be designed to fit snugly around the spinous processes, and thus to avoid being dislodged by movement of the spine. In this embodiment, the spacer 30 achieves a snug fit by including “arms” 34, 36, extending from the blocking portion 32 upward along both sides of the upper spinous process, and “arms” 38, 40 extending from the blocking portion 32 downward along both sides of the lower spinous process. The arms 34, 36, 38, 40 may keep the spacer 30 from moving laterally with respect to the spinous processes. In FIG. 2, spacer 30 is shown in an uncollapsed, generally “H” shaped configuration. The shape as well as the material properties of the spacer may allow it to assume a collapsed configuration which may further allow the spacer to be implanted using a minimally invasive surgical technique.
An interspinous process spacer may be formed from a wide variety of biocompatible materials including those that can undergo reversible elastic deformation. Examples of such materials include elastic or rubbery polymers, hydrogels or other hydrophilic polymers, or composites thereof. Examples of suitable polymers may include silicone, polyurethane, silicone-polyurethane copolymers, polyesters, polyethylenes, polyethyleneterephthaltates, polyaryletherketone (PAEK) polyether block copolymer (PEBAX), ABS (acrylonitrile butadiene styrene), ANS (acrylonitrile styrene), delrin acetal; PVC (polyvinyl chloride), PEN (polyethylene napthalate), PBT (polybutylene terephthalate), polycarbonate, PEI (polyetherimide), PES (polyether sulfone), PET (polyethylene terephthalate), PETG (polyethylene terephthalate glycol), polyamide, aromatic polyamide, polyether, polyester, polymethylmethacrylate, polyurethane copolymer, ethylene vinyl acetate (EVA), ethylene vinyl alcohol, FEP (fluorinated ethylene polymer), PTFE (polytetrafluoroethylen-e), PFA (perfluoro-alkoxyalkane), polypropylene, polyolefin, polysiloxane, liquid crystal polymer, ionomer, poly(ethylene-co-methacrylic) acid, SAN (styrene acrylonitrile), nylon, polyether block amide and thermoplastic elastomer.
The spacer material may be a solid, sheet/film, fiber, mesh and/or braided configurations. The elastomeric material can be formed into a solid one-piece, monoblock unit having the configuration described above. In one alternative, the spacer may be fillable or have otherwise alterable material properties as described more fully below.
Examples of suitable polyurethanes for use in forming a spacer may include thermoplastic polyurethanes, aliphatic polyurethanes, segmented polyurethanes, hydrophilic polyurethanes, polyether-urethane, polycarbonate-urethane and silicone polyetherurethane. Other suitable hydrophilic polymers include polyvinyl alcohol hydrogel, polyacrylamide hydrogel, polyacrylic hydrogel, poly(N-vinyl-2-pyrrolidone hydrogel, polyhydroxyethyl methacrylate hydrogel, and naturally occurring materials such as collagen and polysaccharides, such as hyaluronic acid and cross-linked carboxyl-containing polysaccharides, and combinations thereof.
In other embodiments, the spacer is made of a metal that can undergo reversible elastic deformation, such as shape memory metals or nickel titanium. Further description of interspinous process spacers, of the type shown in FIG. 2, is provided in detail in pending U.S. patent application Ser. No. 10/851,889, entitled “Interspinous Spacer” which is incorporated herein by reference.
FIG. 2 also depicts an interspinous process spacer deformation instrument 42. The instrument 42 includes supports 44, 46 pivotally connected by pivot mechanism 48 and arranged in an “X” shaped configuration. The pivot mechanism 48 may allow the supports 44, 46 to pivotally move relative to each other in the directions shown in FIG. 2. The movement of the pivot mechanism 48 may be controlled or biased by a mechanical spring mechanism, a ratchet mechanism, a shape memory material, or other bias or control mechanisms known in the art. The supports 44, 46 include projections 50, 52, respectively which, as shown in FIG. 2, may be configured to extend between arms 44, 46 of the spacer 30. The projections 50, 52 may be fitted with rollers 54, 56, respectively. The opposite side of the supports 44, 46 may also be fitted with corresponding projections and rollers to fit between arms 38, 40 of the spacer 30.
Referring now to FIG. 3, the deformation instrument 42 may be used to deform the spacer 30 into a collapsed state suitable for implanting the spacer 30 into a patient in a minimally invasive way. With the deformation instrument 42 positioned as shown in FIG. 2 with the rollers 54, 56 engaged with the arms 34, 36, respectively, the supports 44, 46 are pivoted about the pivot mechanism 48. As the supports 44, 46 are moved, the rollers 54, 56 are separated, moving the spacer 30 into a collapsed state with arms 34 and 38 moved toward one another and arms 36, 40 moved toward each other. As the supports 44, 46 are moved, the rollers 54, 56 may roll along the arms 34, 36, reducing friction while collapsing the spacer 30.
A cannula 58 may be inserted into the vicinity of a patient's vertebral column and positioned adjacent to or between the spinous processes 16, 18 of a spinal joint 10. The spacer 30, now in a collapsed state, may be positioned at the opening of the cannula 58. An insertion instrument 60, such as a probe, may then be used to push the spacer 30 along the rollers 54, 56, into the cannula 58, and into the interspinous process space 20. As the spacer 30 is pushed from the cannula 58, it returns from the collapsed state to the uncollapsed state and assumes its original “X” shape with the blocking portion 32 positioned between the adjacent spinous processes 16, 18 and the unfolded arms 34, 38 extending upward and downward along one side of two spinous processes, as shown in FIG. 3. The cannula 58 is then withdrawn as the spacer 30 is ejected, and the second pair of arms 36 and 40 unfolds to extend upward and downward along the second side of the spinous processes, as shown in FIG. 3.
The surgery may be accomplished using, for example, a posterior oblique approach through a small incision in the patient's back. Prior to the implantation of the interspinous process spacer, the interspinous space may be prepared by removing soft tissue from around the spinous processes. The spinous processes may also be distracted to enlarge the space for receiving the spacer.
Referring now to FIG. 4, the spacer 30 may be reduced to a collapsed state using an alternative embodiment of a deformation instrument. The deformation instrument may include a pulling device 70 that may include wires attached to each of the arms 34, 36, 38, 40. In use, the wires may be used to collapse the spacer 30 by pulling arms 38, 38 together and arms 36, 40 together. As shown in FIG. 5, the collapsed spacer 30 may then be introduced to cannula 58, with the wires 70 removed, and implanted between the spinous processes 16, 18 as described above.
Referring now to FIG. 6, a deformation instrument 80 may, alternatively, be used to reduce the spacer 30 from an uncollapsed to a collapsed state. The instrument 80 may comprise a pair of actuators or supports 82, 84 connected by a pivot mechanism 86. In use, the pivot mechanism 86 may be positioned between the arms 34, 36 of the spacer 30 with the supports 82, 84 engaged with the arms. The deformation instrument 80 may include a second pivot mechanism 88 and supports 90, 92 that are substantially similar to those described above for positioning between the arms 38, 40. The movement of the pivot mechanism 86 may be controlled or biased by a mechanical spring mechanism, a ratchet mechanism, a shape memory material, or other bias or control mechanisms known in the art.
With the deformation instrument 80 positioned within the spacer 30, pivot mechanism 86 may be operated to move the supports 82, 84 from a “V” shaped configuration to a straight or elongated configuration (as shown in FIG. 7). The pivot mechanism 88 and supports 90, 92 located between arms 38, 40 may operate in a similar manner to reduce the spacer 30 from an uncollapsed state to a collapsed state. The straightened supports 82, 84, 90, 92 may form a portion of a guide tube which may serve a similar function as the cannula 58 described above.
As shown in FIG. 7, with the collapsed spacer 30 positioned within the guide tube formed by the straightened supports 82, 84, 90, 92, the insertion instrument 60 may be used to push the spacer 30 through the guide tube and into the interspinous process space 20 where it is allowed to return to its uncollapsed state.
Referring now to FIG. 8, in an alternative embodiment to cannula 58 or the guide tube created by supports 82, 84, 90, 92, a multi-part cannula 100 may include two cannula halves 102, 104. The cannula half 102 may be sized and configured to fit within a flare 106 of the cannula 104 to form a single, essentially continuous cannula. The collapsed spacer 30 may be deformed using any of the deformation instruments described above and inserted through the cannula 100 using any of the techniques described above. The multi-part cannula 100 may suitable for situations in which the arms 36, 40 are collapsed prior to collapsing the arms 34, 38. The multi-part cannula 100 allows one half of the spacer 30 to be held in a collapsed position while the opposite half of the spacer is being collapsed.
Referring now to FIG. 9, a spacer 120 includes a body 122 having arms 126, 128 and a body 124 having arms 130, 132. The spacer 120 may further include a spring 134 to bias the arms into an uncollapsed position. Such an embodiment may work much like a pair of scissors, with the four arms 126, 128, 130, 132 extending from a central pivot. As with scissors, the device may be converted from a generally “X”-shaped device to a generally “I”-shaped device by pivoting one pair of arms relative to the other. Such a spacer is disclosed in detail in pending U.S. patent application Ser. No. 10/851,889, entitled “Interspinous Spacer” which is incorporated herein by reference.
The spacer 120 may be collapsed using any of the deformation instruments disclosed above or any other deformation technique known in the art. In a collapsed configuration, as shown in FIG. 9, arms 132, 128 are drawn together, and arms 126, 130 are drawn together. The spacer may then be delivered to the interspinous process space 20 using any of the cannula configurations disclosed above. When the spacer 120 is ejected from the cannula, the spring 134 may bias the spacer 120 to return to its uncollapsed state.
Referring now to FIG. 10, in this embodiment, precision alignment through a minimally invasive approach may be achieved with an installation instrument 110 used to install a spacer 111 between spinous processes 16, 18. The installation instrument 110 includes a fixed member 112 which is connectable to either a fixed location on the patient's body or to an external location. A swing member 114 may have a distal end pivotally connected to the fixed member 112. A proximal end of the swing member 114 may be connected to a curved member 116. The curved member 116 may be a curved cannula capable of receiving an interspinous process spacer. Alternatively, the curved member may have a holder for attaching a spacer to a distal end of the curved member. The swing member 114 may be connected to the curved cannula 116 with a release knob 117 to allow for simplified release and locking of the curved cannula 116 to the swing member 114.
In use, the fixed member 112 may be held stable relative to the interspinous space 20. An interspinous process spacer 111 may be collapsed using one of the methods described above or any other known in the art. With the swing member 114 detached or extended away from the interspinous process space 20, the collapsed spacer may be inserted through the curved cannula 116. The swing arm 114 may then be pivoted to move the curved cannula to the interspinous process space 20. The spacer 111 may then be ejected from the curved cannula 116. The use of the installation instrument 110 may reduce the invasiveness of the spacer implantation by delivering the spacer to the interspinous space with a controlled and precise technique. Such a technique may improve efforts to preserve the surrounding soft tissue. Several features of the minimally invasive installation instrument are disclosed in pending U.S. patent application Ser. No. 10/769,569 which is incorporated herein by reference.
In this embodiment, the spacer 111 may be similar to either spacer 30 or spacer 120 but may include additional features which permit a more minimally invasive implantation using the installation instrument 110. For example, the spacer 111 may be “banana” shaped or slightly curved in the direction of insertion. The curvature of the spacer 111 may match the curvature of the curved cannula 116.
Referring now to FIG. 11, in an alternative embodiment, a cannula 136 may have a distal end section with an opening 138 that may be enlarged to permit distraction of the adjacent spinous processes. In use, the cannula 136 may be inserted through a minimally invasive opening and positioned between the spinous processes 16, 18. Once in position, the opening 138 may be enlarged to further separate the spinous processes and provide additional space to position a spacer. The enlargement of the opening may be mechanically or thermally actuated.
The deformation instruments, installation instruments, and cannula systems described above may also be used to deliver other types of interspinous process devices. For example, as shown in FIGS. 12 and 13, a fillable spacer 140 may inserted between the spinous processes 16, 18 in a collapsed and unfilled state. Once in position, the fillable spacer 140 may be injected or otherwise filled with any of a variety of filling materials to transform the spacer 140 from the collapsed state to an uncollapsed state.
Examples of injectable materials for injection into the inflatable interspinous process spacers include elastomers, hydrogels, or rigid polymers. Examples of elastomers include silicone elastomers, polyurethane elastomers, silicone-polyurethane copolymers, polyolefin rubbers, butyl rubbers, or combinations thereof. Example of hydrogels include polysaccharides, proteins, polyphosphazenes, poly(oxyethylene)-poly(oxypropylene) block polymers, poly(oxyethylene)-poly(oxypropylene) block polymers of ethylene diamine, poly(acrylic acids), poly(methacrylic acids), copolymers of acrylic acid and methacrylic acid, poly(vinyl acetate), sulfonated polymers, or combinations thereof. Examples of rigid polymers include polymethylmethacrylate, silicones, polyurethanes, polyvinyl alcohol, polyamide, aromatic polyamide, polyether, polyesterliquid crystal polymer, ionomer, poly(ethylene-co-methacrylic) acid, PBT (polybutylene terephthalate), polycarbonate, or combinations
Suitable materials may be natural or synthetic. The filling materials may cure or polymerize in situ. The filling materials may be transformable such that when the spacer is filled and in an uncollapsed state, the material may harden to create a rigid spacer.
In an alternative embodiment as shown in FIG. 14, a fillable spacer 150 may include one or more inflatable chambers 152. In this example, the arms of the spacer 150 may be formed of solid elastomeric material and the blocking portion of the spacer may include the inflatable chamber 152 to allow the physician to create a customized distraction between the spinous processes. This spacer 150 may be inserted in a collapsed state, with the arm folded into a low profile package, using any of the instruments described above. When implanted the arms of the spacer 150 may unfold as shown in FIG. 14 and the chamber 152 may be subsequently filled with a material, including those filling materials described above, to distract the spinous processes to a desired level as shown in FIG. 15. The in situ curable materials may cure to a compliant or rigid mass depending upon the materials selected. Biological or pharmaceutical agents may be added to the filling material.
The arms of the spacer may be elastic or rigid and formed of any of the materials listed above. When used with rigid arms, an injectable material capable of setting or curing can lock the rigid arms into a desired position.
The partially inflatable spacer 150 may be incrementally adjustable to allow for better fit and customized distraction. Because the chambers 152 may be filled to different levels, the need to maintain large inventories of implants in a wide variety of sizes may be reduced.
The delivery of any of the spacers described above may facilitated by lubricating any of the instruments described above. Suitable lubricants may include oils, solvents, bodily fluids, fat, saline, or hydrogel coatings. For example, in FIG. 3, a lubricant may be applied to the rollers 54, 56, and to the interior shaft of the cannula 58 to reduce friction and ease the passage of the spacer 30.
In still another alternative, spinous process systems may include artificial ligaments or tethers for connecting two or more spinous processes. These ligaments may be connect to or extend through a spacer and wrap around one or both of the adjacent spinous processes to hold the spacer securely in place. Such ligaments may be elastic or non-elastic and may be made of woven or braided textiles.
Although only a few exemplary embodiments have been described in detail above, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this disclosure. Accordingly, all such modifications and alternative are intended to be included within the scope of the invention as defined in the following claims. Those skilled in the art should also realize that such modifications and equivalent constructions or methods do not depart from the spirit and scope of the present disclosure, and that they may make various changes, substitutions, and alterations herein without departing from the spirit and scope of the present disclosure. It is understood that all spatial references, such as “horizontal,” “vertical,” “top,” “upper,” “lower,” “bottom,” “left,” “right,” “anterior,” “posterior,” “superior,” “inferior,” “upper,” and “lower” are for illustrative purposes only and can be varied within the scope of the disclosure. In the claims, means-plus-function clauses are intended to cover the elements described herein as performing the recited function and not only structural equivalents, but also equivalent elements.

## Claims

1. A method of implanting an interspinous process spacer comprising:
deforming an interspinous spacer having first and second pairs of resiliently deformable arms extending from a central section; the deforming comprising moving the first pair of arms toward each other from an extended configuration to a collapsed configuration;
after the deforming, advancing the spacer in a guide tube with the first pair of arms in the collapsed configuration such that first pair of arms is constrained only by the guide tube;
positioning the guide tube such that a distal portion thereof is disposed proximate a pair of adjacent spinous processes; and
thereafter, pushing the spacer distally through the guide tube such that the first pair of arms and central section exits the distal portion of the guide tube; the first pair of arms exiting the guide tube prior to the central section; the first pair of arms assuming the extended configuration after the exiting such that the first pair arms resiliently move away from each other and move toward the second pair of arms, and wherein the first pair of arms are disposed on a common lateral side of the spinous processes.

2. The method of claim 1 wherein the interspinous spacer is deformed with a deformation instrument having first and second movable portions and the step of deforming further comprises pivoting the first movable portion relative to the second movable portion.

3. The method of claim 2 wherein first and second projections extend outwardly from the first and second movable portions respectively and the step of deforming further comprises engaging the first projection with one of the first pair of arms and engaging the second projection with the other of the first pair of arms.

4. The method of claim 1 wherein when the first pair of arms is moved toward each other, the first pair of arms extend in a generally lateral direction from the central section.

5. The method of claim 1 wherein the guide tube is a first guide tube, the method further comprising:
moving the arms of the second pair of arms toward each other from the extended configuration to the collapsed configuration;
after moving the arms of the second pair of arms, advancing the spacer in a second guide tube with the second pair of arms in the collapsed configuration such that the second pair of arms is constrained only by the second guide tube.

6. The method of claim 5 further comprising inserting the second guide tube at least partially into the first guide tube.

7. A method of implanting an interspinous process spacer comprising:
providing an interspinous process spacer having first, second, third, and fourth arms extending from a central body; the central body having a longitudinal axis;
the spacer having an initial state wherein the first and second arms form a first saddle for receiving a spinous process and the third and fourth arms form a second saddle; the first and second saddles facing away from each other in generally opposite directions;
deforming the spacer to a deformed state by moving the first and third arms toward each other so that the first and third arms are oriented closer to parallel to the longitudinal axis than in the initial state and moving the second and fourth arms toward each other so that the second and fourth arms are oriented closer to parallel to the longitudinal axis than in the initial state;
thereafter, advancing the spacer in a cannula in the deformed state such that the first and third arms are constrained only by the cannula;
thereafter, directing the spacer from the cannula to a position between adjacent upper and lower spinous processes such that the spacer moves from its deformed state towards its initial state, with a first spinous process disposed in the first saddle and an adjacent second spinous process disposed in the second saddle;
wherein when the spacer moves from its deformed state towards its initial state, the first arm moves toward the second arm and the third arm moves toward the fourth arm.

8. The method of claim 7 wherein the spacer is deformed with a deformation instrument having first and second movable portions and the step of deforming further comprises pivoting the first movable portion relative to the second movable portion.

9. The method of claim 7 wherein when the first and third arms are moved toward each other, the first and third arms extend in a generally lateral direction from the central body.

10. The method of claim 7 wherein directing the spacer from the cannula comprises pushing the spacer from the cannula.

11. The method of claim 1 further comprising removing the spacer from the guide tube by pushing the spacer from the guide tube.

12. The method of claim 7 wherein the cannula is a first cannula and the method further comprises:
after moving the second and fourth arms towards each other, advancing the spacer in a second cannula wherein the second and fourth arms are constrained only by the second cannula.

13. The method of claim 12 further comprising inserting the first cannula at least partially into the second cannula.