The present disclosure relates generally to orthopedics and orthopedic surgery. More specifically, the present disclosure relates to devices used to support adjacent spinous processes.
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.
A molding device is disclosed and can include a first mold component and a second mold component substantially opposite the first mold component. The first mold component and the second mold component can fit around a superior spinous process and an inferior spinous process.
In still another embodiment, a molding device is disclosed and can include a first mold component and a second mold component substantially opposite the first mold component. The first mold component and the second mold component can be rotated between an open position and a closed position. Further, the molding device can be placed around an unmolded implant, a superior spinous process, and an inferior spinous process.
In another embodiment, a kit for field use is disclosed and can include a molding device that can be placed around a superior spinous process and an inferior spinous process. Also, the kit can include an expandable interspinous process implant that can be placed between the superior spinous process and the inferior spinous process within the molding device.
In yet another embodiment, a kit for field use is disclosed and can include an unmolded interspinous process implant that can be placed between a superior spinous process and an inferior spinous process. Additionally, the kit can include a molding device that can be placed around the unmolded interspinous process implant.
In another embodiment, a molding device is disclosed and can include a first arm and a first mold can be component attached to the first arm. Further, the molding device can include a second arm substantially opposite the first arm and a second mold component can be attached to the second arm. The first mold component and the second mold component can fit around a superior spinous process and an inferior spinous process.
In yet another embodiment, a molding device is disclosed and can include a first arm and a first mold component can be attached to the first arm. The molding device can also include a second arm substantially opposite the first arm and a second mold component can be attached to the second arm. Moreover, the molding device can be rotated between an open position and a closed position. In the closed position, the molding device can be placed around an implant, a superior spinous process, and an inferior spinous process.
In still 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 and installing a molding device around the expandable interspinous process. Further, the method can include expanding the expandable interspinous process implant to distract the superior spinous process and the inferior spinous process.
Description of Relevant Anatomy
Referring initially to
As shown in
As depicted in
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.
Referring to
As illustrated in
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
Description of a First Embodiment of an Expandable Interspinous Process Implant
Referring to
As illustrated in
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
As illustrated in
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
Description of an Expandable Interspinous Process Implant Installed between Adjacent Spinous Processes and within a First Molding Device
As shown in
As depicted in
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
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
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
Accordingly, the expandable interspinous process implant 1100 can be moved from a relaxed configuration, shown in
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
As depicted in
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
As depicted in
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
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
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
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
In a particular embodiment, as shown in
As illustrated in
Description of a First Method of Treating a Spine
Referring to
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
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
As shown in
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
As shown in
In a particular embodiment, as shown in
As illustrated in
Description of a Second Method of Treating a Spine
Referring to
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 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 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
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
As shown in
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
As shown in
In a particular embodiment, the molding device 3000 can be moved between a closed position, shown in
As illustrated in
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
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 bock 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.
With the configuration of structure described above, the molding device for an expandable interspinous process implant provides a device that can be used to mold an implant along a patient's spine and substantially alleviate or minimize one or more symptoms associated with disc degeneration, facet joint degeneration, or a combination thereof. For example, an 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.
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