# US 7,744,637 B2 · Method for restoring vertebral body height

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- Number: US 7,744,637 B2
- Document ID: US7744637B2
- Status: Granted
- Kind: B2
- Application number: 11/867,867
- Filed: 2007-10-05
- Published: 2008-01-31
- Granted: 2010-06-29
- Earliest claimed: 2001-03-08
- Assignees: Spine Wave, Inc.
- Inventors: Wesley D. Johnson; Tyler Lipschultz; Larry Wales; Robert Kieval
- Web page: https://patentgrep.com/patent/US7744637B2

## CPC

- A61F 2/4455: {for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages (intervertebral discs A61F2/442)}
- A61B 17/025: {Joint distractors}
- A61B 17/66: {Alignment}, compression or distraction mechanisms
- A61B 17/8852: {capable of being assembled or enlarged, or changing shape, inside the bone or disc}
- A61F 2/44: for the spine, e.g. vertebrae or spinal discs
- A61F 2/442: {Intervertebral or spinal discs, e.g. resilient (non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455)}
- A61F 2/4425: {made of articulated components}
- A61F 2/4611: {of spinal prostheses}
- A61B 17/7097: {Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants (disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444)}
- A61B 2017/0256: {for the spine}
- A61F 2/28: Bones
- A61F 2/447: {substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section}
- A61F 2002/30075: {swellable, e.g. when wetted}
- A61F 2002/3008: {radio-opaque, e.g. radio-opaque markers}
- A61F 2002/30237: {partial tubes}
- A61F 2002/30261: {parallelepipedal}
- A61F 2002/30385: {the rib and groove having non-parallel, e.g. conically-tapered, cooperating sides, e.g. having a trapezoidal front cross-section}
- A61F 2002/30387: {Dovetail connection}
- A61F 2002/30392: {Rotation}
- A61F 2002/304: {with additional means for limiting said sliding}
- A61F 2002/30448: {using adhesives}
- A61F 2002/30449: {the adhesive being cement}
- A61F 2002/30462: {retained or tied with a rope, string, thread, wire or cable}
- A61F 2002/30476: {locked by an additional locking mechanism}
- A61F 2002/3049: {using a slidable sleeve covering the connection}
- A61F 2002/305: {Snap connection}
- A61F 2002/30599: {stackable}
- A61F 2002/30604: {modular}
- A61F 2002/30616: {Sets comprising a plurality of prosthetic parts of different sizes or orientations}
- A61F 2002/30772: {Apertures or holes, e.g. of circular cross section}
- A61F 2002/4415: {elements of the prosthesis being arranged in a chain like manner}
- A61F 2002/4485: {comprising three or more adjacent spinal implants}
- A61F 2002/4627: {with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument}
- A61F 2002/4666: {for measuring force, pressure or mechanical tension}
- A61F 2210/0061: swellable
- A61F 2220/0025: Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F 2220/005: using adhesives
- A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
- A61F 2230/0069: cylindrical
- A61F 2230/0082: parallelepipedal
- A61F 2250/0063: Nested prosthetic parts
- A61F 2250/0098: radio-opaque, e.g. radio-opaque markers
- A61F 2310/00017: Iron- or Fe-based alloys, e.g. stainless steel
- A61F 2310/00023: Titanium or titanium-based alloys, e.g. Ti-Ni alloys
- A61F 2310/00029: Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
- A61F 2310/00071: Nickel or Ni-based alloys
- A61F 2310/00203: containing alumina or aluminium oxide
- A61F 2310/00239: containing zirconia or zirconium oxide ZrO2
- A61F 2310/00293: containing a phosphorus-containing compound, e.g. apatite
- A61F 2310/00353: Bone cement, e.g. polymethylmethacrylate or PMMA
- A61F 2310/00359: Bone or bony tissue
- A61F 2310/00365: Proteins; Polypeptides; Degradation products thereof
- Y10S 606/907: Composed of particular material or coated
- Y10S 606/912: Radiolucent material
- Y10S 606/914: Toolkit for installing or removing spinal positioner or stabilizer
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS

## Abstract

A method for distracting, in a given direction, and supporting the opposite endplates of a vertebral body includes consecutively inserting a plurality of wafers between the endplates to create a column of wafers. The column of wafers is oriented between the endplates so as to expand in the given direction as the wafers are consecutively added to the column to restore the vertebral body height.

## Claims

### Claim 1

A method of restoring height to a damaged or diseased vertebral body in a spine, said vertebral body comprising spaced opposing superior and inferior endplates and cancellous bone therewithin, comprising the steps of:
placing an access channel into said cancellous bone between said opposing endplates;
introducing through said access channel a non-inflatable expandable structure into said cancellous bone between said opposing endplates; then
expanding said expandable structure in substantially only the direction of the axis of the spine to distract and support said endplates restoring height to said vertebral body; and then,
introducing bone filler through said access channel into said cancellous bone at a location exteriorly of, adjacent to and in contact with said expanded structure such that said bone filler interdigitates with said cancellous bone and cooperates with said expanded structure to stabilize said vertebral body.

### Claim 2 (depends on 1)

The method of claim 1, wherein said bone filler comprises bone cement.

### Claim 3 (depends on 1)

The method of claim 1, further including the step of providing an expandable structure that comprises openings through which bone filler may flow.

### Claim 4

A method of restoring height to a damaged or diseased vertebral body in a spine, said vertebral body comprising spaced opposing superior and inferior endplates and cancellous bone therewithin, comprising the steps of:
providing access into said cancellous bone between said opposing endplates;
introducing an expandable structure into said cancellous bone between said opposing endplates, wherein said expandable structure comprises a plurality of substantially similarly configured elements, said expandable structure being formed in vivo by consecutive individual insertion of each of said elements into said cancellous bone and in contact with each other;
expanding said expandable structure in the direction of the axis of the spine to distract and support said endplates restoring height to said vertebral body; and then,
introducing bone filler into said cancellous bone at a location exteriorly of, adjacent to and in contact with said expanded structure such that said bone filler interdigitates with said cancellous bone and cooperates with said expanded structure to stabilize said vertebral body.

### Claim 5 (depends on 4)

The method of claim 4, wherein said elements are configured to cause said expansion in said substantially only one direction upon said consecutive insertion.

### Claim 6

A method of restoring height to a damaged or diseased vertebral body in a spine, said vertebral body comprising spaced opposing superior and inferior endplates and cancellous bone therewithin, comprising the steps of:
placing an access channel into said cancellous bone between said opposing endplates;
introducing through said access channel a non-inflatable expandable structure having an upper contact face and a lower contact face into said cancellous bone between said opposing endplates, the structure having openings to receive a bone filler and to facilitate movement of such bone filler therethrough; then
expanding said expandable structure with said upper face and said lower face moving substantially only in the direction of the axis of the spine to distract and support said endplates restoring height to said vertebral body; and then,
introducing bone filler through said access channel into and through said openings of said expanded structure to stabilize said vertebral body.

### Claim 7 (depends on 6)

The method of claim 6, wherein bone filler comprises bone cement.

### Claim 8 (depends on 6)

The method of claim 6, wherein said step of providing access is practiced by an access channel having a passageway therethrough, said access channel being placed into said vertebral body with said passageway in communication with said cancellous bone.

### Claim 9 (depends on 8)

The method of claim 8, wherein said step of introducing said non-inflatable expandable structure is practiced by an inserter releasably supporting said expandable structure, said inserter being configured to pass through said passageway of said access channel.

### Claim 10

The method of claim of 9, wherein said step of introducing said bone filler is practiced by a bone delivery device separate from and additional to said inserter and including a delivery channel configured to pass through said access channel passageway in communication with said cancellous bone upon release of said inserter from said structure and removal from said access channel.

### Claim 11

The method of claim of 9, wherein said step of introducing said bone filler is practiced with said inserter.

### Claim 12 (depends on 6)

The method of claim 6, wherein said upper contact face and said lower contact face are moved substantially in parallel.

### Claim 13 (depends on 6)

The method of claim 6, wherein said upper contact face and said lower contact face are moved to an oblique orientation.

### Claim 14

A method of restoring height to a damaged or diseased vertebral body in a spine, said vertebral body comprising spaced opposing superior and inferior endplates and cancellous bone therewithin, comprising the steps of:
providing access into said cancellous bone between said opposing endplates;
introducing a non-inflatable expandable structure into said cancellous bone between said opposing endplates, wherein said expandable structure comprises a plurality of substantially similarly configured elements, said expandable structure being formed in vivo by consecutive individual insertion of each of said elements into said cancellous bone and in contact with each other, the structure having openings to receive a bone filler and to facilitate movement of such bone filler therethrough;
expanding said expandable structure in the direction of the axis of the spine to distract and support said endplates restoring height to said vertebral body; and then,
introducing bone filler into and through said openings of said expanded structure to stabilize said vertebral body.

### Claim 15 (depends on 14)

The method of claim 14, wherein said elements are configured to cause said expansion in said substantially only one direction upon said consecutive insertion.

### Claim 16

A method of restoring height to a damaged or diseased vertebral body in a spine, said vertebral body comprising spaced opposing superior and inferior endplates and cancellous bone therewithin, comprising the steps of:
providing access into said cancellous bone between said opposing endplates;
providing a delivery member having a delivery passage, said delivery member movably supporting a plunger communicating with said delivery passage;
disposing a plurality of elements adjacent one another in a linear array in said passage;
placing said delivery member in communication with said access to said cancellous bone:
moving said plunger along the delivery passage to apply a force to said elements to move said elements into said cancellous bone in contact with each other to distract and support said endplates thereby restoring height to said vertebral body; and
introducing bone filler into said vertebral body in contact with said elements to stabilize said vertebral body.

### Claim 17 (depends on 16)

The method of claim 16, wherein said elements are configured to form an expandable structure upon movement of said elements into said cancellous bone.

### Claim 18 (depends on 17)

The method of claim 17, wherein said elements are configured to cause expansion of said structure in said substantially only one direction.

### Claim 19 (depends on 18)

The method of claim 18, wherein said bone filler is introduced after said structure is expanded.

### Claim 20 (depends on 16)

The method of claim 16, wherein said elements are tethered together to form a continuous linear array of elements.

### Claim 21 (depends on 20)

The method of claim 20, wherein said tether is formed of a thin section of deformable material defining a linear array of spaced individual elements each joined by a tether.

### Claim 22 (depends on 21)

The method of claim 21, wherein said elements and said tethers are integrally formed from a continuous piece of material.

### Claim 23 (depends on 16)

The method of claim 16, wherein said elements define one or more channels to facilitate the movement of bone filler therein.

### Claim 24 (depends on 16)

The method of claim 16, wherein each of said elements is provided with a leading end and a trailing end, at least the leading end of one of said elements comprising an angled surface.

### Claim 25

A method of restoring height to a damaged or diseased vertebral body in a spine, said vertebral body comprising spaced opposing superior and inferior endplates and cancellous bone therewithin, comprising the steps of:
providing access into said cancellous bone between said opposing endplates;
introducing through said access a non-inflatable expandable structure into said cancellous bone between said opposing endplates; then
expanding said expandable structure in the direction of the axis of the spine to distract and support said endplates restoring height to said vertebral body; and then,
introducing an injection channel having at least one opening into said access and advancing said injection channel within said vertebral body until said at least one opening approximates the expanded structure;
injecting a bone filler through the injection channel directly into the interior of the vertebral body adjacent the distraction component.

### Claim 26 (depends on 25)

The method of claim 25, wherein said expandable structure is substantially solid and said filler is placed at a location exteriorly of, adjacent to and in contact with said expanded structure such that said bone filler interdigitates with said cancellous bone and cooperates with said expanded structure to stabilize said vertebral body.

### Claim 27 (depends on 25)

The method of claim 25, wherein said expandable structure has at least one opening and wherein said filler is injected into said expanded structure and through said at least one opening into surrounding cancellous bone.

### Claim 28 (depends on 25)

The method of claim 25, further including an access channel having a passageway, said access channel being placed through said access into said vertebral body, and wherein said expandable structure is introduced through said passageway in a non-expanded condition.

### Claim 29 (depends on 28)

The method of claim 28, wherein after expanding said expandable structure said access channel is maintained in place and said injection channel is introduced through said access channel to inject said filler.

### Claim 30 (depends on 25)

The method of claim 25, wherein said expandable structure is configured for expansion in substantially only one direction.