WO2007146464A1

WO2007146464A1 - Expandable interspinous process implant and method of installing same

Info

Publication number: WO2007146464A1
Application number: PCT/US2007/064600
Authority: WO
Inventors: Thomas A. Carls; Kent M. Anderson; Eric C. Lange; Roy K. Lim; Hai H. Trieu; Aurelien Bruneau
Original assignee: Warsaw Orthopedic, Inc.
Priority date: 2006-04-28
Filing date: 2007-03-22
Publication date: 2007-12-21
Also published as: US20070270825A1; US7846185B2

Abstract

An expandable interspinous process implant is disclosed and can include a body and an injection tube extending from the body. The expandable interspinous process implant can be moved from a relaxed configuration to an expanded configuration in which the body is at least partially inflated around a superior spinous process and an inferior spinous process.

Description

EXPANDABLE INTERSPINOUS PROCESS IMPLANT AND METHOD OF

INSTALLING SAME

Field of the disclosure

The present disclosure relates generally to orthopedics and orthopedic surgery. More specifically, the present disclosure relates to devices used to support adjacent spinous processes Background

In human anatomy, the spine is a generally flexible column thai can take tensile and compressive loads. The spine also allows bending motion and provides a place of attachment for keels, muscles and ligaments. Generally, the spine is divided into three sections: the cervical spine, the thoracic spine and the lumbar spine. The sections of the spine are made op of individual bones called vertebrae. Also, the vertebrae are separated by intervertebral discs, which are situated between adjacent vertebrae.

The intervertebral discs function as shock absorbers and as joints. Further, the intervertebral discs can absorb the compressive and tensile loads to which the spinal column may be subjected At the same time, the intervertebral discs can allow adjacent vertebral bodies to move relative to each other a limited amount, particularly during bending, or flexure, of the spine. Thus, the intervertebral discs are under constant muscular and/or gravitational pressure and generally, the intervertebral discs are the first parts of the lumbar spine to show signs of deterioration.

Facet joint degeneration is also common because the facet joints are in almost constant motion with the spine In fact, facet joint degeneration and disc degeneration frequently occur together. Generally, although one may be the primary problem while the other is a secondary problem resulting from the altered mechanics of the spine, by the time surgical options are considered, both facet joint degeneration and disc degeneration typically have occurred For example, the altered mechanics of the facet joints and/or intervertebral disc may cause spinal stenosis, degenerative spondylolisthesis, and degenerative scoliosis. Brief Description of lhe Drawings

FlG. ! is a lateral view of a portion of a vertebral column;

FIG. l is a lateral view of a pair of adjacent vertrebrae; FIG 3 is a top plan view of a vertebra,

FlG. 4 is a view of a first expandable interspinous process implant in a relaxed configuration,

FlG. 5 is a view of the first expandable interspinous process implant with an injection tube removed:

FIG. 6 is a view of a second expandable interspinous process implant in a relaxed configuration,

FIG, ? is a view of the second expandable interspinous process implant with an injection tube removed:

RG. 8 ts a view of an expandable interspinous process implant in a relaxed configuration between adjacent spinous processes and within a first molding device;

FKJ, 0 is a view of the expandable interspinous process implant in an expanded, molded configuration between adjacent spinous processes and within the first molding device;

FIG. 10 is a view of the expandable interspinous process implant in an expanded, molded configuration between adjacent spinous processes;

FIG I l is a \ iew of an expandable interspinous process implant in a relaxed configuration between adjacent spinous processes:

FIG. i2 is a view of the expandable interspinous process implant in an expanded, unniolded configuration between adjacent spinous processes and within a second molding device;

FIG. 13 is a view of the expandable interspinous process implant in an expanded, molded configuration between adjacent spinous processes and within the second molding device;

FIG. 14 is a view of the expandable interspinous process implant in an expanded, molded configuration between adjacent spinous processes;

FIG. 15 is a view of an expandable interspinous process implant in a relaxed configuration between adjacent spinous processes and within a third molding device;

FIG. 16 is a view of an expandable interspinous process implant in a relaxed configuration between adjacent spinous processes and within a third molding device, shown in cross-section: FIG. 17 is a view of the expandable interspinous process implant in an expanded, molded configuration between adjacent spinous processes and within the third molding device,

FlG. 18 is a view of the expandable interspinous process implant in an expanded, molded configuration between adjacent spinous processes and within the third molding device, shown in cross-section;

FICJ S 9 is a view of the expandable interspinous process implant in an expanded, molded configuration between adjacent spinous processes;

FlG. 20 is a side plan view of a first molding device,

RG. 21 is rear plan view of the first molding device,

FIG. 22 is a cross-section view of the first molding device taken along line 22-22 in HG. 21 ;

FIG 23 is a cross-section view of the first molding device installed around adjacent spinous processes;

FIG. 24 is a flow chart illustrating a first method of treating a spine;

FIG. 25 is a side plan view of a second molding device;

FIG 2b is rear plan view of the second molding device,

FIG. 27 is a cross-section view of the second molding device taken along iirse 27- 27 in FIG. 26;

FIG. 28 is a cross-section view of the second molding device installed around adjacent spinous processes;

FIG. 29 is a flow chart illustrating a second method of treating a spine,

FIG. 30 is a side plan view of a third molding device;

FIG. 31 is a rear plan view of the third molding device;

FIG. 32 is a front plan view of the third molding device,

FKJ, 33 is a cross-section view of the third molding device in a closed position taken along line 33-33 in FΪG. 3 1 ;

FIG. 34 is another cross-section view of the third molding device in a closed position taken along line 34-34 in FIG. 3 1 ;

FlG. 35 is a cross-section view of the third molding device in an open position, and

FIG. 36 is a flow chart illustrating a third method of treating a spine. DETAILED DESCRIPTION OF THE DRAWINGS

A method of treating a spine is disclosed and can include installing a molding device around a superior spinous process and an inferior spinous process. The method can also include installing an expandable mterspmous process implant within the molding device. Further, the method can include expanding the expandable interspinous process implant to substantially conform to a volume bound by the molding device, the superior spinous process, and the inferior spinous process

In another embodiment, a method of treating a spine is disclosed and can include distracting a superior spinous process and an inferior spinous process and installing a molding device around the superior spinous process and the inferior spinous process. Also, the method can include installing an expandable interspinous process implant within the molding device and expanding the expandable interspinous process implant to substantially conform to a volume bound by the molding device, the superior spinous process, and the inferior spinous process,

In yet another embodiment a method of treating a spine is disclosed and can include installing an expandable interspinous process implant between a superior spinous process and an inferior spinous process The method can also include expanding the expandable interspinous process implant to an expanded configuration. Jn the expanded configuration, the expandable interspinous process implant can be at least partially inflated around the superior spinous process and the inferior spinous process. Additionally, the method can include installing a molding device around the superior spinous process, the inferior spinous process, and the expandable interspinous process implant. Moreover, the method can include moving the molding device from an open position to a closed position to mold the expandable interspinous process implant to substantially conform to a volume bound by the molding device, the superior spinous process, and the inferior spinous process

In still another embodiment, a method of treating a spine is disclosed and can include distracting a superior spinous process and an inferior spinous process, installing an expandable interspinous process implant between the superior spinous process and the inferior spinous process, and expanding the expandable interspinous process implant to an expanded configuration. In the expanded configuration, the expandable interspinous process implant can be at least partially inflated around the superior spinous process and the inferior spinous process Further, the method can include installing a molding device around the superior spinous process, the inferior spinous process, and the expandable interspinous process implant and moving the molding device from an open position to a closed position to moid the expandable interspinous process implant to substantially conform to a volume bound by the molding device, the superior spinous process, and the inferior spinous process

In yet still another embodiment, a method of treating a spine is disclosed and can include installing an imerspinous process implant between a superior spinous process and an inferior spinous process and installing a molding device around the superior spinous process, the inferior spinous process, and the imerspinous process implant. Also, the method can include moving the molding device from an open position to a closed position to mold the interspinous process implant at least partially around the superior spinous process and the inferior spinous process.

In still yet another embodiment, a method of treating a spine is disclosed and can include distracting a superior spinous process and an inferior spinous process, installing an interspinous process implant between the superior spinous process and the inferior spinous process, and installing a molding device around the superior spinous process, the inferior spinous process, and the interspinous process implant. Moreover, the method can include moving the molding device from an open position to a closed position to mold the interspinous process implant at least partially around the superior spinous process and the inferior spinous process.

In another embodiment, an expandable interspinous process implant is disclosed and can include a body and an injection tube extending from the body The expandable interspinous process implant can be moved from a relaxed configuration to an expanded configuration in which the body is at least partially inflated around a superior spinous process and an inferior spinous process. Description of Relevant Anatomy

Referring initially to FIG. 1, a portion of a \ertebral column, designated 100. is shown. As depicted, the vertebral column 100 includes a lumbar region 102, a sacral region 104. and a coccygeal region 106. As is known in the art, the vertebral column 100 also includes a cervical region and a thoracic region. For clarity and ease of discussion, the cervical region and the thoracic region are not illustrated.

As shown in FiG, i, the lumbar region 102 includes a first lumbar vertebra 108. a second lumbar vertebra 1 10, a third lumbar vertebra 112, a fourth lumbar vertebra i 14, and a fifth lumbar vertebra 1 16 The sacral region 104 includes a sacrum 118. Further, the coccygeal region 106 includes a coccyx 120.

As depicted in FΪG. I ₅ a first intervertebral lumbar disc 122 is disposed between the first lumbar vertebra 108 and the second lumbar vertebra 110. A second intervertebral lumbar disc 124 is disposed between the second lumbar vertebra 1 10 and the third lumbar vertebra 1 12, A third intervertebral lumbar disc 126 is disposed between the third lumbar vertebra 1 12 and the fourth lumbar vertebra 1 14, Further, a fourth intervertebral lumbar disc 128 is disposed between the fourth lumbar vertebra 1 14 and the fifth lumbar vertebra S 16. Additionally, a fifth intervertebral lumbar disc 130 is disposed between the fifth lumbar vertebra ! 16 and the sacrum 118.

In a particular embodiment, if one of the intervertebral lumbar discs 122, 124, 126, 128, 130 is diseased, degenerated, damaged, or otherwise in need of repair, augmentation or treatment, that intervertebral lumbar disc 122, 124, 126, 128, 130 can be treated in accordance with one or more of the embodiments described herein FIG 2 depicts a detailed lateral view of two adjacent vertebrae, e.g , two of the lumbar vertebra SOS, 1 10, ! 12, 1 14, ! 16 shown in FlG. 1. FlG. 2 illustrates a superior vertebra 200 and an inferior vertebra 202. As shown, each vertebra 20O₅ 202 includes a vertebral body 204, a superior articular process 206, a transverse process 208, a spinous process 210 and an inferior articular process 212 FΪG 2 further depicts an intervertebral disc 216 between the superior vertebra 200 and the inferior vertebra 202 As described in greater detail below, a collagen material according to one or more of the embodiments described herein can be injected within the intervertebral disc 216 to treat a degenerative or otherwise deleterious condition

Referring to FlG. 3, a vertebra, e.g., the inferior vertebra 202 (FlG. 2), is illustrated. As shown, the vertebral body 204 of the inferior vertebra 202 includes a cortical rim 302 composed of cortical bone Also, the vertebral body 204 includes cancellous bone 304 within the cortical rim 302. The cortical rim 302 is often referred to as the apophyseal rim or apophyseal ring Further, the cancellous bone 304 is softer than the cortical bone of the cortical rim 302

As illustrated in FIG. 3, the inferior vertebra 202 further includes a first pedicle 306, a second pedicle 308, a first lamina 3 i 0, and a second lamina 3 12 Further, a vertebral foramen 314 is established within the inferior vertebra 202 A spina! cord 316 passes through the vertebral foramen 314, Moreover, a first nerve root 3 18 and a second nerve root 320 extend from the spinal cord 316

It is well know n in the art that the vertebrae that make up the vertebral column have slightly different appearances as they range from the cervical region to the lumbar region of the vertebral column. However, all of the vertebrae, except the first and second cervical vertebrae, have the same basic structures, e.g , those structures described above in conjunction with FIG. 2 and FIG. 3. The first and second cervical vertebrae are structurally different than the rest of the vertebrae in order to support a skull.

Description of a First Embodiment of an Expandable lnterspinous Process implant Referring to FIG. 4 and FlG. 5, a first expandable interspinous process implant is shown and is generally designated 400. As shown, the expandable interspinous process implant can include a hollow, expandable body 402. In a particular embodiment the expandable body 402 can be made from one or more elastic biocompatible materials. For example, the materials can be silicone, polyurethane, polycarbonate urethane, polyethylene terephthalate. silicone copolymers, polyolefin, or any combination thereof. As illustrated in FIG. 4, the expandable interspinous process implant 400 can further include an injection tube 404 FlG. 5 indicates that the injection tube 404 can be removed, e.g , after the expandable interspinous process implant 400 is inflated

In a particular embodiment, the expandable interspinous process implant 400 can be injected with one or more injectable biocompatible materials that become substantially rigid after curing. Further, the injectable biocompatible materials can include polymer materials that become substantially rigid yet remain elastic after curing Also, the injectable biocompatible materials can include ceramics

For example, the polymer materials can include polyurethane, polyolefin, silicone, silicone polyurethane copolymers, polymethylmethacrylate, epoxy, cyanoacrylate, hydrogels. resorbable polymers, or a combination thereof Further, the polyolefϊn materials can include polypropylene, polyethylene, halogenated polyoleftn, and flouropolyolefin. The hydrogels can include polyacryl amide (PA AM h poly-N-isopropylacrylaniine (PNlPAM), polyvinyl methyl ether (P VM), polyvinyl alcohol (PVA), polyethyl hydroxyethyl cellulose, poly (2-etbyl) oxazoliπe, polyelhyleneoxide (PEO), polyethylglycol (PEG), polyacrylacid (PAA), polyacrylonitrile (PAN), poly virrylacry late (PVA), polyvinylpyrrolidone (PVP), or a combination thereof The resorbable polymers can include polylactide (PLA), polyglycolide (PGA), polyiactide-co-glycolide (PLG), Poiy~e-caprolacloϊie, polydiaoxanone, polyanhydride, trimethylene carbonate, poly -13- hydroxybυtyrate (PHB), poly~g-ethyl glutamate, poly-DTH- irainocarbonate, poly- bisphenoi-A-iminocarbonate), polyorthoester (POE), polyglycolic lactic acid (PGLA), or a combination thereof.

In a particular embodiment, the ceramics can include calcium phosphate, hydroxyapatite. calcium sulfate, bioactive glass, or a combination thereof, In an alternative embodiment, the injectable biocompatible materials can include one or more fluids such as sterile water, saline, or sterile air. In certain embodiments, the body can be provided with a seal (not shown) or one way valve (not shown) to maintain the injectable biocompatible material within the body

Description of a Second Embodiment of an Expandable lnterspinous Process implant

Referring to FlG. 6 and FlG 7, a second expandable interspinous process implant is shown and is generally designated 600. As shown, the expandable interspinous process implant can include a hollow, expandable body 602 In a particular embodiment, the expandable body 602 can be made from one or røore elastic biocompatible materials For example, the materials can be silicone, polyurethane, polycarbonate urethane, polyethylene terephthalate, silicone copolymers, polyolefin, or any combination thereof As illustrated in FlG 6, the expandable interspinous process implant 600 can further include an injection tube 604 FIG 7 indicates that the injection tube 604 can be removed, e.g., after the expandable interspinous process implant 600 is inflated

In a particular embodiment, the expandable interspinous process implant 600 can be injected with one or more injectable biocompatible materials that become substantially rigid after curing. Further, the injectable biocompatible materials can include polymer materials that become substantially rigid yet remain elastic after curing. Also, the injectable biocompatible materials can include ceramics.

For example, the polymer materials can include polyurethane, polyolefln, silicone, silicone polyurethane copolymers, polymethylmethacrylate, epoxy, cyanoacrylate, hydrogels, resorbable polymers, or a combination thereof. Further, the polyolefln materials can include polypropylene, polyethylene, halogenated polyoleiln, and ftourøpol yol efin .

The hydrogels can include poiyacrylamide (PAAM), poly-N-isopiopylacryiamine (PN IPAM), polyvinyl methylether (PVM), polyvinyl alcohol (PVA), polyethyl hydroxyethyi cellulose, poly (2-ethyl) oxazoline, polyethyleneoxide (PEO), polyethylglycol (PEG)₅ polyacrylacid (PAA), polyacrylonUrile (PAN), polyvinyl acrylate (PVA), polyvinylpyrrolidone (PVP), or a combination thereof. The resorbable polymers can include polylaetide (PLA), polyglycolide (PGA), polylactide-co-glycolide (PLG), Poly-e-caprolactone, polydiaoxanone, polyanhydride, trimethylene carbonate, poly-^β- hydroxybutyrate (PFIB). po!y-g-ethyl gliUamate, poly-DTH- iminocarbonate, poly- bisphenol-A-iminocarbonate), polyorthoester (POE), polyglycolic lactic acid (PGLA), or a combination thereof in a particular embodiment, the ceramics can include calcium phosphate, hydroxy apatite, calcium sulfate, bioactive glass, or a combination thereof. Io an alternative embodiment, the injectable biocompatible materials can include one or more fluids such as sterile water, saline, or sterile air.

Referring back Io FIG. 6 and FlG 7, the expandable interspinous process implant 600 can include one or more bands 606 there around. The bands 606 can be integrally formed with the body 602. Alternatively, the bands 606 can be disposed on an outer surface of the body 602. ϊn a particular embodiment, the bands 606 can reinforce the body 602. Further, the bands 606 can confine the body 602 and prevent the body 602 from expanding radially.

Description of an Expandable lnterspinous Process Implant Installed between Adjacent Spinous Processes and within a First Molding Device IO

As shown in FlG 8 through FlG. 10, an expandable interspinous process implant 800, having a body 802 and an injection tube 804, can be installed between a superior spinous process 000 and an inferior spinous process 902 in a particular embodiment, the expandable interspinous process implant 800 is an expandable interspinous process implant 800 according to one or more embodiments described herein.

As depicted in FlG. 8 and FlG 9, a molding device !000 can be placed around the expandable interspinous process implant 800 and the spinous processes 900, 902 Further, the expandable interspinous process implant 800 can be inflated with an injectable biocompatible material, e g., one or more of the materials described herein. Accordingly, the expandable interspinous process implant 800 can be moved from a relaxed configuration, shown in FlG 8, to an expanded, molded configuration, shown in FlG 9 and FIG 10. In the expanded, molded configuration, the expandable interspinous process implant 800 can substantially conform to a volume bound by the molding device 1000 and the spinous processes 9(XJ, 902 Further, in the expanded, molded configuration the expandable interspinous process implant 800. e.g., the body 802. can be partially inflated around the spinous processes 900, 902

After the expandable interspinous process implant 800 is injected with the injectable biocompatible material, the injectable biocompatible material can be cured and the injection tube 804 and the molding device i000 can be removed, as shown in FIG. i0 As depicted in FIG. 10, the expandable interspinous process implant 800 can provide support for the spinous processes 900, 902 and prevent a distance 910 between the spinous processes 900, 902 from substantially decreasing - other than slight temporary decreases due Io the elasticity of the cured biocompatible material within the expandable interspinous process implant 800.

In another embodiment, a distractor can be used to increase the distance between the superior spinous process 900 and the inferior spinous process 902 and the expandable interspinous process implant 800 can be expanded within the distracted superior spinous process 902 and the inferior spinous process 900. After the expandable interspinous process implant 800 is inflated and cured as described herein, the distractor can be removed and the expandable interspinous process implant 800 can support the superior spinous process 900 and the inferior spinous process 902 and substantially prevent the distance 9] 0 between the superior spinous process 900 and the inferior spinous process 902 from returning to a pre-dtstraction value.

Description of an Expandable Interspinoυs Process Implant Installed between Adjacent Spinous Processes and within a Second Molding Device

As shown in FlG 1 1 through FlG 14, an expandable interspinous process implant 1 100, having a body 1 102 and an injection tube 1 104, can be installed between a superior spinous process S 200 and an inferior spinous process 1202 In a particular embodiment the expandable interspinous process implant 1 100 is an expandable interspinous process implant 1100 according to one or more embodiments described herein

FlG. 12 illustrates that the expandable interspinous process implant 1 100 can be inflated between the superior spinous process 1200 and the inferior spinous process 1202. For example, the expandable interspinoυs process implant 1 100 can be inflated with an injectable biocompatible material e g., one or more of the materials described herein.

After the expandable interspinous process implant 1 100 is inflated between the spinous processes 1200, 1202. the injection tube 1 104 can be removed and a molding device 1300 can be placed around the expandable interspinoυs process implant 1 100 and the spinous processes 1200, 1202. The molding dev ice 1300 can be moved between an open position, shown in FlG. 12. and a closed position, shown in FIG. 13. Jn the closed position, the molding device 1300 can cause the expandable interspinous process implant ! 100 to substantially conform to the area bound by the molding device ! 300 and the spinous processes 120O₅ 1202.

Accordingly, the expandable interspinous process implant 1 100 can be moved from a relaxed configuration, shown in FlG 1 1. Io an expanded, uπmolded configuration, shown in FIG 12. Further, the expandable interspinous process implant 1 100 can be moved from the expanded, υnniolded configuration to an expanded, molded configuration, in the expanded, molded configuration, the expandable interspinous process implant 1 100 can substantially conform to a volume bound by the molding device 1300 and the spinous processes 1200, 1202 Further, in the expanded, molded configuration the expandable interspinous process implant 1 100, e.g., the body 1 102, can be partially inflated around the spinous processes 1200, 1202. After the expandable interspinous process impiant ϊ 100 is injected with the injectable biocompatible materia] and molded as described herein, the injectable biocompatible material can be cured and the molding device L>00 can be removed, as shown in FIG. 14. In various embodiments, the injectable biocompatible material can be cured by application of an energy source or by chemical activation or in any art- recognized manner appropriate to the material used. In certain embodiments, the injection tube can be retained in place after injection in order to provide a conduit for delivering a curing agent into the body

As depicted in FlG 14, the expandable interspinous process implant 1 100 can provide support for the spinous processes 1200, 1202 and substantially prevent a distance 1210 between the spinous processes 1200, 1202 from decreasing - other than slight temporary decreases due to the elasticity of the cured biocompatible material within the expandable interspinous process implant 800.

In another embodiment, a distractor can be used to increase the distance between the superior spinous process 1200 and the inferior spinous process 1202 and the expandable interspinous process implant 1100 can be expanded within the distracted superior spinous process 1202 and the inferior spinous process 1200. After the expandable interspinous process implant 1 100 is inflated, molded, and cured as described herein, the distractor can be removed and the expandable interspinous process implant ! 100 can support the superior spinous process 1200 and the inferior spinous process 1202 and substantially prevent the distance 1210 between the superior spinous process 1200 and the inferior spinous process 1202 from returning to a pre-distraction value.

Description of an Expandable Interspinous Process Implant Installed between Adjacent Spinous Processes and within a Third Molding Device

As shown in FIG. 15 through FIG. 19, an expandable interspinous process implant 1500, having a body 1 502 and an injection tube 1504, can be installed between a superior spinous process 1600 and an inferior spinous process 1602. In a particular embodiment, the expandable interspinous process implant 1500 is an expandable interspinous process implant 1500 according to one or more embodiments described herein.

As depicted in FlG. 15 through FlG. 18, a molding device 1700 can be placed around the expandable interspinous process implant 1500 and the spinous processes 1600, 1602. Further, the expandable interspinous process implant 1500 can be inflated with an injectable biocompatible materia!, e.g , one or more of the materials described herein Accordingly, the expandable interspinous process implant i 500 can be moved from a relaxed configuration, shown in FIG. 15 and FlG. 16, to an expanded, molded configuration, shown in FlG. 17 through FlG. 19 As the expandable interspinous process implant 1500 expands, it can distract the spinous processes 1600, 1602 and increase a distance 1610 therebetween. Further, m the expanded, molded configuration, the expandable interspinous process implant 1500 can substantially conform to a volume bound by the molding device 1700 and the spinous processes 1600, 1602 Further, in the expanded, molded configuration the expandable interspinous process implant 1500.. e g., the body 1502, can be partially inflated around the spinous processes 1600, 1602

After the expandable interspinous process implant 1500 is injected with the injectable biocompatible material, the injectable biocompatible material can be cured and the injection tube 1504 and the molding device 1700 can be removed, as shown in FlG. 19, As depicted in FlG. 19, the expandable interspinous process implant 1500 can provide support for the spinous processes 1600, 1602 and prevent the distance 1610 between the spinous processes 1600, 1602 from substantially decreasing - other than slight temporary- decreases due to the elasticity of the cured biocompatible material within the expandable interspinous process implant 1500

In another embodiment, a distractor can be used to increase the distance between the superior spinous process 1600 and the inferior spinous process 1602 and the expandable interspinous process implant 1500 can be expanded within the distracted superior spinous process 1602 and the inferior spinous process 1600. After the expandable interspinous process implant 1 500 is inflated and cured as described herein, the distractor can be removed and the expandable interspinous process implant 1500 can support the superior spinous process 1600 and the inferior spinous process 1602 and substantially prevent the distance 1610 between the superior spinous process 1600 and the inferior spinous process 1602 from returning to a pre-distraction value. Description of a First Molding Dev ice

Referring now to FlG 20 through FlG 23, a first embodiment of a molding device is shown and is generally designated 2000. As shown, the molding device 2000 includes a body 2002 that can include a proximal end 2004 and a distal end 2006. A handle 2008 can be attached to the proximal end 2004 of the body 2002.

FiG, 20 and FIG. 2 1 indicate that a first support post 2020 can extend from the distal end 2006 of the body 2002. Specifically, the first support post 2020 can include a proximal end 2022 and a distal end 2024 and the proximal end 2022 of the first support post 2020 can be connected, or otherwise attached, to the distal end 2006 of the body 2002.

Moreover, a first mold component 2026 can be attached to. or otherwise extend from, the distal end 2024 of the first support post 2020 As shown in FIG. 22, the first mold component 2026 can include a proximal end 2028 and a distal end 2030 The first mold component 2026 can also include an interior surface 2032 and an exterior surface 2034.

FIG 20 and FIG. 21 indicate that a second support post 2040 can extend from the distal end 2006 of the body 2002 Specifically, the second support post 2040 can include a proximal end 2042 and a distal end 2044 and the proximal end 2042 of the second support post 2040 can be connected, or otherwise attached, to the distal end 2006 of the body 2002.

Moreover, a second mold component 2046 can be attached to, or otherwise extend from, the distal end 2044 of the second support post 2040. As shown in FiG. 22, the second moid component 2046 can include a proximal end 2048 and a distal end 2050 The second mold component 2046 can also include an interior surface 2052 and an exterior surface 2054.

In a particular embodiment, as shown in FIG. 23, the molding device 2000 can be placed around adjacent spinous processes such that the proximal end 2028, 2048 of each mold component 2026. 2046 can be near a first spinous process 2300. Further, the distal end 2030, 2050 of each mold component 2026, 2046 can be mm^~ a second spinous process 2302

As illustrated in FIG 23, the interior surfaces 2032. 2052 of the mold components 2026. 2046 and the spinous processes 2300, 2302 can create a volume into which an expandable interspinous process implant can be inserted, expanded, and molded, as described herein. Description of a First Method of Treating a Spine

Referring to FlG. 24, a method of treating a spine is shown and commences at block 2400. At block 2400, a patient can be secured in a prone position, e.g., on an operating table. At block 2402, the posterior spine can be exposed in order to expose adjacent spinous processes. Further, at block 2404, a surgical retractor system can be installed to keep a surgical field open.

Moving Io block 2406, a molding device can be inserted around I wo adjacent spinous processes In a particular embodiment, the molding device can be a molding device according to one or more of the embodiments described herein At block 2408, an expandable interspinous process implant can be installed within the molding device between the adjacent spinous processes, hi a particular embodiment, the expandable interspinous process implant can be an expandable interspinous process implant according to one or more of the embodiments described herein.

At block 2410. an injectable biocompatible material can be injected into the expandable interspinous process implant. In a particular embodiment, the injectable biocompatible material can be one or more of the materials described herein. Proceeding to decision step 2412, it can be determined whether the fit of the expandable interspinous process implant is correct. In other words, it can be determined whether to inject more material into the expandable interspinous process implant At decision step 2412, if the fit of the expandable interspinous process implant is not correct, the method returns to block 2410 and more material can be injected into the expandable interspinous process implant Thereafter, the method can continue as described herein.

Returning to decision step 2412, if the fit of the expandable interspinous process implant is correct, the method can proceed to block 2414 and the material within the expandable interspinous process implant can be cured. In a particular embodiment, the material within the expandable interspinous process implant can cure naturally, i.e., under ambient conditions, in situ. Alternatively, the material within the expandable interspinous process implant can be cured in situ using an energy source For example, the energy source can be a light source that emits visible light infrared (IR) light or ultra-violet (IJV) light. Further, the energy source can be a heating device, a radiation device, or other mechanical device. Moving to block 2416. an injection tube can be removed from the expandable interspinous process implant. Further, at bock 2418, the expandable interspinous process implant can be sealed. In a particular embodiment the expandable interspinous process implant can be sealed by curing the material within the expandable interspinous process implant. Alternatively, a plug, a dowel, or another similar device can be used to seal the expandable interspinous process implant. Further, a one-way valve can be incorporated into the expandable interspinous process implant and can allow material to be injected into the expandable interspinous process implant, but prevent the same material from being expelled from the expandable interspinous process implant.

Continuing to block 2420, the molding device can be removed from around the spinous processes and the expandable interspinous process implant. Thereafter, at block 2422, the surgical area can be irrigated. Λt block 2424, the retractor system can be removed Further, at block 2426, the surgical wound can be closed. The surgical wound can be closed by simply allowing the patient's skin to close due to the elasticity of the skin. Alternatively, the surgical wound can be closed using sutures, surgical staples, or any other suitable surgical technique well known in the art. At block 242S₅ postoperative care can be initiated The method can end at state 2430 lii a particular embodiment, the spinous processes can be distracted prior to inserting the molding device and the expandable interspinous process implant After the expandable interspinous process implant is inflated, molded, and cured as described herein, the distract or can be removed and the expandable interspinous process implant can support the superior spinous process and the inferior spinous process and substantially prevent a distance between the superior spinous process and the inferior spinous process from returning to a pre-distraction value. Description of a Second Molding Device

Referring now to FlG 25 through FlG 28, a second embodiment of a molding device is shown and is generally designated 2500. As shown, the molding device 2500 includes a body 2502 that cars include a proximal end 2504 and a distal end 2506. A handle 2508 can be attached to the proximal end 2504 of the body 2502 FlG 25 and FlG 26 indicate that a first support post 2520 can extend from the distal end 2506 of the body 2502 Specifically, the first support post 2520 can include a proximal end 2522 and a distal end 2524 and the proximai end 2522 of the first support post 2520 can be rotably engaged with the distal end 2506 of the hods 2502

Moreover, a first mold component 2526 can be attached to. or otherwise extend from, the distal end 2524 of the first support post 2520 As shown in FIG 27, the first mold component 2526 can include a pioximai end 2528 and a distal end 2530 The first mold component 2526 can also include an interior surface 2532 and an exterior surface 2534

Λs shown in FIG ! 0 and KIG 25, a first handle 2536 can extend from the proximal end 2522 of the first support post 2520 The first handle 2536 can be used to rotate the first support post 2520 relativ e to the body 2502

FIG 25 and FlG 26 indicate that a second support post 2540 can extend fioπi the distai end 2506 of the body 2502 Specifically, the second support post 2540 can include a proximal end 2542 and a distal end 2544 and the proximal end 2542 of the second support post 2540 can be rotably engaged with to the distal end 2506 of the body 2502

Moreover, a second mold component 2546 can be attached to. or otherwise extend from, the distal end 2544 of the second suppoπ post 2540 Λs shown in FlG 27, the second moid component 2546 can include a proximal end 2548 and a distal end 2550 I he second mold component 2546 can also include an interior surface 25^2 and an exterior surface 2554

Λs shown in FIG 19 and FlG 25, a second handle 2556 can extend from the proximal end 2542 of the first support post 2540 The second handle 2556 can be used to rotate the second support post 2540 relative to the body 2502

In a particular embodiment, as shown in FIG 27 and FiG 28, the molding device 2500 can be moved between an open position, indicated in dashed lines, and a closed position, indicated in solid lines Fuither, as shown in F1G 28, the molding device 2500 can be placed along a patient^'s sptne and moved from the open position to the closed position In the closed position, the proximal end 252S, 2548 of each mold component 2526. 2546 can be near a first spinous process 2800 Further, the distal end 2530, 2550 of each mold component 2526, 2546 can be near a second spinous process 2802

Λs illustrated in WG 28, in the closed position, the interior surfaces 2532. 2552 of the mold components 2526. 2546 and the spinous processes 2800, 2802 can create a ! 8 volume into which an expandable interspinous process implant can be molded as described herein

Description of a Second Method of Treating a Spine

Referring to FlG, 2^C>, a second method of treating a spine is shown and commences at block 2900. At block 2°00, a patient can be secured in a prone position, e g.. on an operating fable. At block 2902, the posterior spine can be exposed in order to expose adjacent spinous processes Further, at block 2904, a surgical retractor system can be installed to keep a surgical field open.

Moving to block 2906, an expandable interspinous process implant can be installed between the adjacent spinous processes In a particular embodiment, the expandable interspinous process implant can be an expandable interspinous process implant according to one or more of the embodiments described herein. At Mock 2908. an injectable biocompatible material can be injected into the expandable interspinous process implant. In a particular embodiment, the injectable biocompatible materia! can be one or more of the materials described herein.

Proceeding to block 291O₅ an injection tube can be removed from the expandable interspinous process implant. Thereafter, at bock 2912, the expandable interspinous process implant can be sealed. In a particular embodiment, the expandable interspinous process implant can be sealed by curing the materia! within the expandable interspinous process implant. Alternatively, a plug, a dowel, or another similar device can be used to seal the expandable interspinous process implant Further, a one-way valve can be incorporated into the expandable interspinous process implant and can allow material to be injected into the expandable interspinous process implant, but prevent the same material from being expelled from the expandable interspinous process implant

At block 2914, a molding device can be inserted around two adjacent spinous processes ϊn a particular embodiment, the molding device can be a molding device according to one or more of the embodiments described herein Continuing to block 2916, the molding device is rotated from an open position to a closed position around the expandable interspinous process. Accordingly, the expandable interspinous process can be molded by the molding device and substantially conform a volume bound by the molding device and the spinous processes. Proceeding to block 2918, the materia! within the expandable interspinous process implant can be cured ϊn a particular embodiment, the materia! within the expandable interspinous process implant can cure naturally, i.e., under ambient conditions, in situ. Alternatively, the material within the expandable interspinous process implant can be cured in situ using an energy source. For example, the energy source can be a light source that emits visible light, infrared (TR) light, or ultra-violet (UV) light Further, the energy source can be a heating device, a radiation device, or other mechanical device.

At to block 2920, the molding device can be removed from around the spinous processes and the expandable interspinous process implant. Thereafter, at block 2922. the surgical area can be irrigated. At block 2024, the retractor system can be removed. Further, at block 2926, the surgical wound can be closed. The surgical wound can be closed by simply allowing the patient's skin to close due to the elasticity of the skin. Alternatively, the surgical wound can be closed using sutures, surgical staples, or any other suitable surgical technique well known in the art. At block 2928, postoperative care can be initiated. The method can end at state 2930.

In a particular embodiment, the spinous processes can be distracted prior to inserting the expandable interspinous process implant and the molding device. After the expandable interspinous process implant is inflated, molded, and cured as described herein, the distractor can be removed and the expandable interspinous process implant can support the superior spinous process and the inferior spinous process and substantially prevent a distance between the superior spinous process and the inferior spinous process from returning to a pre-distraction value Description of a Third Molding Device

Referring now to FIG. 30 through FIG. 35, a third embodiment of a molding device is shown and is generally designated 3000. As shown, the molding device 3000 includes a body 3002 that can include a proximal end 3004 and a distal end 3006. A handle 3008 can be attached to the proximal end 3004 of the body 3002.

FIG. 30 through FIG. 32 indicate that a first support post 3020 can extend from the distal end 3006 of the body 3002. Specifically, the first support post 3020 can include a proximal end 3022 and a distal end 3024 and the proximal end 3022 of the first support post 3020 can be rotably engaged with the distal end 3006 of the body 3002. Moreover, a first ami 3026 can be attached to, or otherwise extend from, the distal end 3024 of the first support post 3020 Further, a first mold component 3028 can be attached to the first arm 3026. As shown in FiG. 33 through FiG. 35, the first arm 3026 can include a proximal end 3030 and a distal end 3032 FIG. 33 and FlG. 35 indicate that the first mold component 3028 can include an opening 3034 Moreover, as indicated in FlG 34, the first mold component 3028 can include an interior surface 3036

As shown bi FlG 19 and FlG. 30, a fust handle 3038 can extend from the proximal end 3022 of the first support post 3020. The first handle 3038 can be used to rotate the first support post 3020 relative to the body 3002

FlG. 30 and FKI 32 indicate that a second support post 3040 can extend from the distal end 3006 of the body 3002. Specifically, the second support post 3040 can include a proximal end 3042 and a distal end 3044 and the proximal end 3042 of the second support post 3040 can be rotably engaged with to the distal end 3006 of the body 3002. Moreover, a second arm 3046 can be attached to, or otherwise extend from, the distal end 3044 of the second support post 3040. Further, a second mold component 3048 can be attached to the second arm 3046. As shown in FIG 33 through FIG 35, the second arm 3046 can include a proximal end 3050 and a distal end 3052. FlG. 33 and FIG 35 indicate that the second mold component 3048 can include an opening 3054 Moreover, as indicated in FIG. 34, the second mold component 3048 can include an interior surface 3056.

As shown in FIG. 19 and FlG 30, a second handle 3O5S can extend from the proximal end 3042 of the first support post 3040. The second handle 3056 can be used to rotate the second support post 3040 relative to the body 3002.

In a particular embodiment, the molding

ice 3000 can be moved between a closed position, shown in FlG 33 and FIG. 34, and an open position, shown in FIG. 35 Further, as shown tn FlG 33 and FIG, 34, the molding device 3000 can be placed along a patient^'s spine and moved from the open position to the closed position In the closed position, the proximal end 3030, 3050 of each arm 3026, 3046 can be near a first spinous process 3300. Further, the distal end 3032, 3052 of each arm 3026, 3046 can be near a second spinous process 3302. As illustrated in FIG. 34, in the closed position, the interior surfaces 3036, 3056 of the mold components 3028, 3048 and the spinous processes 3300, 3302 can create a volume into which an expandable interspinous process implant can be molded, as described herein. Additionally, in the closed position, the mold components 3028, 3048 create an open ended, barrel-shaped mold that can constrain expansion of an expandable process implant in a radial direction, relative to the mold. However, the mold components 3028, 3048 can allow expansion of the expandable process implant in a longitudinal direction, relative to the mold Accordingly, as the expandable process implant is inflated, it can expand through the open ends of the mold components 3028, 3048 and distract the spinous processes 3300, 3302,

Also, in a particular embodiment, the openings 3034, 3054 formed in the moid components 3028, 3048 can allow the mold components 3028, 3048 to be closed around an injection tube of the expandable interspinous process implant. Description of a Third Method of Treating a Spine

Referring to FIG. 36, a third method of treating a spine is shown and commences at block 3600 At biock 3600, a patient can be secured in a prone position, e.g , on an operating table. At block 3602, the posterior spine can be exposed in order to expose adjacent spinous processes. Further, at block 3604, a surgical retractor system can be installed to keep a surgical field open.

Moving to block 3606, an expandable interspinous process implant can be installed between the adjacent spinous processes. In a particular embodiment, the expandable interspinous process implant can be an expandable interspinous process implant according to one or more of the embodiments described herein At biock 3608, a molding device can be installed around the expandable interspinous process implant. In a particular embodiment, the molding device can be a molding device according to one or more of the embodiments described herein.

At block 3610, an injectable biocompatible material can be injected into the expandable interspinous process implant In a particular embodiment the injectable biocompatible material can be one or more of the materials described herein Continuing to decision step 3612, it can be determined whether a distraction of a superior spinous process and an inferior spinous process is correct. If not, the method can return to block 3610 and additional material can be injected into the expandable interspinous process implant Thereafter, the method can proceed as described herein If the distraction is correct, the method can proceed to block 361-1

At block 3(314, an injection tube can be removed from the expandable mterspmous process implant Thereafter, at bock 3616, the expandable interspinous process implant can be sealed In a particular embodiment, the expandable mterspinous process implant can be sealed by curing the material within the expandable interspinous process implant Alternativ ely, a plug, a dowel, or another similar dev ice can be used to seal the expandable iπterspiπous process implant Further, a one-way valve can be incorporated into the expandable interspinous process implant and can allow material to be injected into the expandable interspinous process implant but prevent the same material from being expelled from the expandable interspinous piocess implant

Proceeding to 3618, the material within the expandable interspinous process implant can be cured In a particular embodiment, the material within the expandable interspinous process implant can cure naturally, i c , under ambient conditions, in situ Alternativ ely, the material within the expandable interspinous process implant can be cured in situ using an energ> source For example, the energ\ source can be a light source that emits visible light, infrared (IR) light, or ultra-violet (U V) light Further, the energy source can be a heating device, a radiation device, or other mechanical device

At to block 3620, the molding device can be rotated from a closed position to an open position Next, at block 3622, the molding device can be removed from aiound the spinous processes and the expandable interspinous process implant Moving to block 3624 the surgical area can be irrigated At block 3626 the retractor system can be removed Further, at block 3628, the surgical wound can be closed The surgical wound can be closed b> simply allowing the patient^'s skin to close due to the elasticity of the skin '\ltemati\ely, the surgical wound can be closed using sutures, surgical staples or anv, other suitable surgical technique well known in the ait At block 3630, postoperative care can be initiated The method can end at state 3632.

In a particular embodiment, the spinous processes can be distracted prior to inserting the expandable interspinous process implant and the molding device After the expandable interspinous process implant is inflated, molded, and cured as described herein, the distractor can be removed and the expandable interspinous process implant can support the superior spinous process and the inferior spinous process and substantially prevent a distance between the superior spinous process and the inferior spinous process from returning to a pre-distraction value Conclusion

With the configuration of structure described above, the expandable interspinous process implant provides a device that can be used to treat a spine and substantially alleviate or minimize one or more symptoms associated with disc degeneration, facet joint degeneration, or a combination thereof. For example, the expandable interspinous process implant can be installed between adjacent spinous processes, expanded, molded., and cured in order to support the spinous processes and maintain them at or near a predetermined distance there between.

The above-disclosed subject matter is to be considered illustrative, and not restrictive, and the appended claims are intended to cover all such modifications, enhancements, and other embodiments that fall within the true spirit and scope of the present invention Thus, to the maximum extent allowed by law, the scope of the present invention is to be determined by the broadest permissible interpretation of the following claims and their equivalents, and shall not be restricted or limited by the foregoing detailed description.

Claims

What is claimed is:

1. An expandable interspinoυs process implant, comprising: a body; and an injection tube extending from the body, wherein the expandable interspinous process implant is movable from a relaxed configuration to an expanded configuration in which the body is at least partially inflated around a superior spinous process and an inferior spinous process.

2. The expandable interspinous process implant of claim 1 , wherein the expandable interspinous process implant is configured to be expanded within a molding device placed around the superior spinous process and the inferior spinous process.

3. The expandable interspinous process implant of claim 2. wherein the expandable interspinous process implant is configured to substantially conform to a volume bound by the molding device, the superior spinous process, and the inferior spinous process.

4. The expandable interspinous process implant of claim L further comprising a band around the body.

5. The expandable interspinous process implant of claim 22, wherein the band is integrally formed with the body.

6. The expandable interspinous process implant of claim 4. wherein the band prevents a portion of the body from expanding.

7. The expandable interspinous process implant of claim 4, wherein the band reinforces a portion of the body.

8. The expandable interspinous process implant of claim 1 , wherein the body is configured to receive an injectable biocompatible material. ^c>. The expandable interspinous process implant of claim 8, wherein the injectable biocompatible materia! comprises a polymer, a ceramic, or a combination thereof.

, polyethylglycol (PEG), polyacrylacid (PAA), polyaerylonitrile (PAN), polyvinylacrylate (PVA), polyvinylpyrrolidone (PVP), or a combination thereof.

10. The expandable interspinous process implant of claim 8, wherein the injectable biocompatible materia! comprises a fluid.

1 1. The expandable inierspinous process implant of claim 10, wherein the fluid comprises sterile water, saline, or sterile air