# Patent

## Title
Expandable interspinous process implant and method of installing same

## 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.

## Background
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 that 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 up 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 THE DRAWINGS
FIG. 1 is a lateral view of a portion of a vertebral column;
FIG. 2 is a lateral view of a pair of adjacent vertebrae;
FIG. 3 is a top plan view of a vertebra;
FIG. 4 is a view of a first expandable interspinous process implant in a relaxed configuration;
FIG. 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. 7 is a view of the second expandable interspinous process implant with an injection tube removed;
FIG. 8 is a view of an expandable interspinous process implant in a relaxed configuration between adjacent spinous processes and within a first molding device;
FIG. 9 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. 11 is a view of an expandable interspinous process implant in a relaxed configuration between adjacent spinous processes;
FIG. 12 is a view of the expandable interspinous process implant in an expanded, unmolded 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;
FIG. 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;
FIG. 19 is a view of the expandable interspinous process implant in an expanded, molded configuration between adjacent spinous processes;
FIG. 20 is a side plan view of a first molding device;
FIG. 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 FIG. 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. 26 is rear plan view of the second molding device;
FIG. 27 is a cross-section view of the second molding device taken along line 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;
FIG. 33 is a cross-section view of the third molding device in a closed position taken along line 33-33 in FIG. 31;
FIG. 34 is another cross-section view of the third molding device in a closed position taken along line 34-34 in FIG. 31;
FIG. 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 interspinous 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. 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. 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 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 yet still another embodiment, a method of treating a spine is disclosed and can include installing an interspinous 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 interspinous 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 vertebral 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. 1, the lumbar region 102 includes a first lumbar vertebra 108, a second lumbar vertebra 110, a third lumbar vertebra 112, a fourth lumbar vertebra 114, and a fifth lumbar vertebra 116. The sacral region 104 includes a sacrum 118. Further, the coccygeal region 106 includes a coccyx 120.
As depicted in FIG. 1, 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 110 and the third lumbar vertebra 112. A third intervertebral lumbar disc 126 is disposed between the third lumbar vertebra 112 and the fourth lumbar vertebra 114. Further, a fourth intervertebral lumbar disc 128 is disposed between the fourth lumbar vertebra 114 and the fifth lumbar vertebra 116. Additionally, a fifth intervertebral lumbar disc 130 is disposed between the fifth lumbar vertebra 116 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 108, 110, 112, 114, 116 shown in FIG. 1. FIG. 2 illustrates a superior vertebra 200 and an inferior vertebra 202. As shown, each vertebra 200, 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. FIG. 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 FIG. 3, a vertebra, e.g., the inferior vertebra 202 (FIG. 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 310, and a second lamina 312. Further, a vertebral foramen 314 is established within the inferior vertebra 202. A spinal cord 316 passes through the vertebral foramen 314. Moreover, a first nerve root 318 and a second nerve root 320 extend from the spinal cord 316.
It is well known 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 Interspinous Process implant
Referring to FIG. 4 and FIG. 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. FIG. 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 polyolefin materials can include polypropylene, polyethylene, halogenated polyolefin, and flouropolyolefin.
The hydrogels can include polyacrylamide (PAAM), poly-N-isopropylacrylamine (PNIPAM), polyvinyl methylether (PVM), polyvinyl alcohol (PVA), polyethyl hydroxyethyl cellulose, poly (2-ethyl) oxazoline, polyethyleneoxide (PEO), polyethylglycol (PEG), polyacrylacid (PAA), polyacrylonitrile (PAN), polyvinylacrylate (PVA), polyvinylpyrrolidone (PVP), or a combination thereof. The resorbable polymers can include polylactide (PLA), polyglycolide (PGA), polylactide-co-glycolide (PLG), Poly-e-caprolactone, polydiaoxanone, polyanhydride, trimethylene carbonate, poly-β-hydroxybutyrate (PHB), poly-g-ethyl glutamate, 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, 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 Interspinous Process Implant
Referring to FIG. 6 and FIG. 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 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. 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, polyolefin, silicone, silicone polyurethane copolymers, polymethylmethacrylate, epoxy, cyanoacrylate, hydrogels, resorbable polymers, or a combination thereof. Further, the polyolefin materials can include polypropylene, polyethylene, halogenated polyolefin, and flouropolyolefin.
The hydrogels can include polyacrylamide (PAAM), poly-N-isopropylacrylamine (PNIPAM), polyvinyl methylether (PVM), polyvinyl alcohol (PVA), polyethyl hydroxyethyl cellulose, poly(2-ethyl) oxazoline, polyethyleneoxide (PEO), polyethylglycol (PEG), polyacrylacid (PAA), polyacrylonitrile (PAN), polyvinylacrylate (PVA), polyvinylpyrrolidone (PVP), or a combination thereof The resorbable polymers can include polylactide (PLA), polyglycolide (PGA), polylactide-co-glycolide (PLG), Poly-e-caprolactone, polydiaoxanone, polyanhydride, trimethylene carbonate, poly-β-hydroxybutyrate (PHB), poly-g-ethyl glutamate, 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, 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.
Referring back to FIG. 6 and FIG. 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. In 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 Interspinous Process Implant Installed between Adjacent Spinous Processes and within a First Molding Device
As shown in FIG. 8 through FIG. 10, an expandable interspinous process implant 800, having a body 802 and an injection tube 804, can be installed between a superior spinous process 900 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 FIG. 8 and FIG. 9, a molding device 1000 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 FIG. 8, to an expanded, molded configuration, shown in FIG. 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 900, 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 1000 can be removed, as shown in FIG. 10. 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 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 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 910 between the superior spinous process 900 and the inferior spinous process 902 from returning to a pre-distraction value.
Description of an Expandable Interspinous Process Implant Installed between Adjacent Spinous Processes and within a Second Molding Device
As shown in FIG. 11 through FIG. 14, an expandable interspinous process implant 1100, having a body 1102 and an injection tube 1104, can be installed between a superior spinous process 1200 and an inferior spinous process 1202. In a particular embodiment, the expandable interspinous process implant 1100 is an expandable interspinous process implant 1100 according to one or more embodiments described herein.
FIG. 12 illustrates that the expandable interspinous process implant 1100 can be inflated between the superior spinous process 1200 and the inferior spinous process 1202. For example, the expandable interspinous process implant 1100 can be inflated with an injectable biocompatible material, e.g., one or more of the materials described herein.
After the expandable interspinous process implant 1100 is inflated between the spinous processes 1200, 1202, the injection tube 1104 can be removed and a molding device 1300 can be placed around the expandable interspinous process implant 1100 and the spinous processes 1200, 1202. The molding device 1300 can be moved between an open position, shown in FIG. 12, and a closed position, shown in FIG. 13. In the closed position, the molding device 1300 can cause the expandable interspinous process implant 1100 to substantially conform to the area bound by the molding device 1300 and the spinous processes 1200, 1202.
Accordingly, the expandable interspinous process implant 1100 can be moved from a relaxed configuration, shown in FIG. 11, to an expanded, unmolded configuration, shown in FIG. 12. Further, the expandable interspinous process implant 1100 can be moved from the expanded, unmolded configuration to an expanded, molded configuration. In the expanded, molded configuration, the expandable interspinous process implant 1100 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 1100, e.g., the body 1102, can be partially inflated around the spinous processes 1200, 1202.
After the expandable interspinous process implant 1100 is injected with the injectable biocompatible material and molded as described herein, the injectable biocompatible material can be cured and the molding device 1300 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 FIG. 14, the expandable interspinous process implant 1100 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 1100 is inflated, molded, and cured as described herein, the distractor can be removed and the expandable interspinous process implant 1100 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 1502 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 FIG. 15 through FIG. 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 material, e.g., one or more of the materials described herein. Accordingly, the expandable interspinous process implant 1500 can be moved from a relaxed configuration, shown in FIG. 15 and FIG. 16, to an expanded, molded configuration, shown in FIG. 17 through FIG. 19. As the expandable interspinous process implant 1500 expands, it can distract the spinous processes 1600, 1602 and increase a distance 1610 therebetween. Further, in 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 FIG. 19. As depicted in FIG. 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 1500 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 Device
Referring now to FIG. 20 through FIG. 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. 21 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 mold 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 near 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 FIG. 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 to block 2406, a molding device can be inserted around two 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. 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 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 (UV) 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 block 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. At 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 2428, postoperative care can be initiated. The method can end at state 2430.
In 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 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 Second Molding Device
Referring now to FIG. 25 through FIG. 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 can 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.
FIG. 25 and FIG. 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 proximal end 2522 of the first support post 2520 can be rotably engaged with the distal end 2506 of the body 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 proximal end 2528 and a distal end 2530. The first mold component 2526 can also include an interior surface 2532 and an exterior surface 2534.
As shown in FIG. 19 and FIG. 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 relative to the body 2502.
FIG. 25 and FIG. 26 indicate that a second support post 2540 can extend from the distal 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 support post 2540. As shown in FIG. 27, the second mold component 2546 can include a proximal end 2548 and a distal end 2550. The second mold component 2546 can also include an interior surface 2552 and an exterior surface 2554.
As shown in FIG. 19 and FIG. 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. Further, as shown in FIG. 28, the molding device 2500 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 2528, 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.
As illustrated in FIG. 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 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 FIG. 29, a second method of treating a spine is shown and commences at block 2900. At block 2900, a patient can be secured in a prone position, e.g., on an operating table. 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 block 2908, 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 block 2910, an injection tube can be removed from the expandable interspinous process implant. Thereafter, at block 2912, 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.
At block 2914, a molding device can be inserted around two 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. 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 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 (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 2924, 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 arm 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 FIG. 35 indicate that the first mold component 3028 can include an opening 3034. Moreover, as indicated in FIG. 34, the first mold component 3028 can include an interior surface 3036.
As shown in FIG. 19 and FIG. 30, a first 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.
FIG. 30 and FIG. 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. FIG. 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 FIG. 30, a second handle 3058 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 device 3000 can be moved between a closed position, shown in FIG. 33 and FIG. 34, and an open position, shown in FIG. 35. Further, as shown in FIG. 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 mold 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 block 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 block 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 3614.
At block 3614, an injection tube can be removed from the expandable interspinous process implant. Thereafter, at block 3616, 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.
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.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 (UV) 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 around 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 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 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

1. A method of treating a spine, comprising:
moving a mold relative to a flexible interspinous process implant so as to laterally bound the implant in an interspinous space between superior and inferior spinous processes; the mold comprising first and second mold parts;
thereafter, while the implant is disposed in the mold and in the interspinous space, changing a compressibility of the implant by performing at least one of the following:
inflating the implant; or
curing a curable material of the implant; and

wherein the moving step comprises moving the mold from an open position to a closed position by moving the first mold part relative to the second mold part; and
wherein moving the mold from the open position to the closed position comprises pivoting the first mold part relative to the second mold part.

2. A method of treating a spine, comprising:
moving a mold relative to a flexible interspinous process implant so as to laterally bound the implant in an interspinous space between superior and inferior spinous processes; the mold comprising first and second mold parts;
thereafter, while the implant is disposed in the mold and in the interspinous space, changing a compressibility of the implant by performing at least one of the following:
inflating the implant; or
curing a curable material of the implant; and

wherein the moving step comprises positioning the first and second mold parts on opposing lateral sides of the superior and inferior spinous processes and thereafter inserting the flexible implant between the first and second mold parts.

3. A method of treating a spine, comprising:
moving a mold relative to a flexible interspinous process implant so as to laterally bound the implant in an interspinous space between superior and inferior spinous processes; the mold comprising first and second mold parts;
thereafter, while the implant is disposed in the mold and in the interspinous space, changing a compressibility of the implant by performing at least one of the following:
inflating the implant; or
curing a curable material of the implant; and

wherein the first and second mold parts are rigid prior to and during the changing the compressibility step.

4. A method of treating a spine, comprising:
moving a mold relative to a flexible interspinous process implant so as to laterally bound the implant in an interspinous space between superior and inferior spinous processes; the mold comprising first and second mold parts;
thereafter, while the implant is disposed in the mold and in the interspinous space, changing a compressibility of the implant by performing at least one of the following:
inflating the implant; or
curing a curable material of the implant; and

wherein the moving step comprises moving the mold from an open position to a closed position by moving the first mold part relative to the second mold part; and
wherein in the open position, the first mold part is disposed more proximally than a first lateral side of the implant and the second mold part is disposed more distally than a second lateral side of the implant, the second lateral side being opposite the first lateral side;
in the closed position the first mold part engages the first lateral side of the implant and the second mold part engages the second lateral side of the implant.