WO2005072301A2 - Percutaneous spine distraction implant systems and methods - Google Patents

Percutaneous spine distraction implant systems and methods Download PDF

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Publication number
WO2005072301A2
WO2005072301A2 PCT/US2005/002163 US2005002163W WO2005072301A2 WO 2005072301 A2 WO2005072301 A2 WO 2005072301A2 US 2005002163 W US2005002163 W US 2005002163W WO 2005072301 A2 WO2005072301 A2 WO 2005072301A2
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WO
WIPO (PCT)
Prior art keywords
spinous processes
adjacent spinous
taper
arms
angle
Prior art date
Application number
PCT/US2005/002163
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French (fr)
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WO2005072301A3 (en
Inventor
Mark A. Reiley
Original Assignee
Reiley Mark A
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Publication date
Application filed by Reiley Mark A filed Critical Reiley Mark A
Publication of WO2005072301A2 publication Critical patent/WO2005072301A2/en
Publication of WO2005072301A3 publication Critical patent/WO2005072301A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/025Joint distractors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7062Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7062Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
    • A61B17/7065Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00557Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/025Joint distractors
    • A61B2017/0256Joint distractors for the spine

Definitions

  • the invention generally relates to systems and methods for treating conditions of the spine, and, in particular, systems and methods for distending the spine and/or blocking and/or limiting spinal extension for treating, e.g., spinal stenosis.
  • Spinal stenosis is a narrowing of the spinal canal . The narrowing of the spinal canal itself does not usually cause any symptoms.
  • the pain starts in the legs and moves upward to the buttocks; in other patients the pain begins higher in the body and moves downward.
  • the pain may radiate or may be a cramping pain. In severe cases, the pain can be constant, excruciating, and debilitating.
  • spinal stenosis occurs as the gradual result of aging and "wear and tear" on the spine during everyday activities. The incidence of spinal stenosis increases as people exceed 50 years of age. Stenosis can sometimes be treated without surgery, e.g., through the use of medications, steroid injections, rest or restricted activity, or physical therapy.
  • surgical treatments can be performed, e.g., decompressive laminectomy, laminotomy, foraminotomy, cervical discectomy and fusion, cervical corpectomy, and laminoplasty.
  • decompressive laminectomy, laminotomy, foraminotomy, cervical discectomy and fusion, cervical corpectomy, and laminoplasty The use of surgically implanted devices that distract the spine, called the X-Bar, has also been advocated, e.g., as disclosed in United States Patent 6,451,020.
  • These surgical techniques though effective for many, are invasive. They require exposure of a section of the spine through an open incision, approximately two inches in length, made along the midline of the back, for excision of vertebral lamina or the placement of an implant between adjacent spinous processes.
  • the present invention overcomes the problems and disadvantages associated with current strategies and systems in the treatment of spinal stenosis by invasive, open surgical procedures.
  • One aspect of the invention provides systems and methods for treating spinal stenosis.
  • the systems and methods direct an implant device to a position resting between the adjacent spinous processes.
  • the device is sized and configured to distend the adjacent spinous processes.
  • the device can also block or limit extension of the back.
  • the device includes a region that, in use, receives a spinous process. The region tapers from a high surface to a low surface in an anterior-to-posterior direction.
  • Fig. 1 shows a vertebra with a normal neuroforamen.
  • Fig. 2 shows the passage of the spinal cord and nerve roots in a normal neuroforamen.
  • Fig. 3 shows a vertebra with a stenotic neuoforamen, i.e., a neuroforamen that has a reduced sized, compared to the neuroforaman shown in Fig. 1.
  • Fig. 4 shows the narrowing of the spaces in the spine that results in pressure on the spinal cord and/or nerve roots, causing nerves to swell and become inflamed.
  • Fig. 1 shows a vertebra with a normal neuroforamen.
  • Fig. 2 shows the passage of the spinal cord and nerve roots in a normal neuroforamen.
  • Fig. 3 shows a vertebra with a stenotic neuoforamen, i.e., a neuroforamen that has a reduced sized, compared to the neuroforaman shown in Fig. 1.
  • Fig. 4 shows
  • FIG. 5 shows a device that has been implanted by percutaneous access between adjacent first and second spinous processes of the stenotic vertebrae shown in Fig. 4 to relieve the pressure on the spinal cord and/or nerve roots .
  • Fig. 6 shows the device shown in Fig. 5 as it exists outside the body, prior to implantation.
  • Figs . 7 to 12 show the implantation of the device shown in Fig. 6 by percutaneous access.
  • Fig. 13 shows an alternative embodiment of a device that can be implanted by percutaneous access between adjacent first and second spinous processes of the stenotic vertebrea to relieve the pressure on the spinal cord and/or nerve roots .
  • Figs. 14 to 16 show the implantation of the device shown in Fig. 13 by percutaneous access.
  • FIG. 17 shows the device shown in Fig. 13 after implantation.
  • Fig. 18A shows an alternative embodiment of a device that can be implanted by percutaneous access between adjacent first and second spinous processes of the stenotic vertebrea to relieve the pressure on the spinal cord and/or nerve roots .
  • Fig. 18B is a section view of the device taken generally along line 18B-18B in Fig. 18A.
  • Fig. 19 shows the implantation of the device shown in Fig. 18A by percutaneous access.
  • Fig. 20 shows the device shown in Fig. 18A after implantation.
  • Fig. 21 is a section view of the device taken generally along line 21-21 in Fig. 20. Figs .
  • FIG. 22A and 22B are perspective views of an alternative embodiment of a device that can be implanted by percutaneous access between adjacent first and second spinous processes of the stenotic vertebrea to relieve the pressure on the spinal cord and/or nerve roots and having a hinge mechanism and in which the angle of the inclined planes may be controlled by a series of screws and bores .
  • FIG. 23 is a side view of the device of Figs. 22A and 22B implanted between adjacent first and second spinous processes of the stenotic vertebrae and in a contracted condition.
  • Fig. 24 is a side view similar to Fig. 23 and illustrating the device in an enlarged condition which relieves pressure on the spinal cord and/or nerve roots.
  • Fig. 23 is a side view of the device of Figs. 22A and 22B implanted between adjacent first and second spinous processes of the stenotic vertebrae and in a contracted condition.
  • Fig. 24 is a side view similar to Fig. 23 and illustrating the device in an enlarged condition
  • FIG. 25 is a top plan view of the bottom arm of the device of Figs. 22A and 22B illustrating a configuration and placement of screws and bores which serves to raise the incline planes of the device upon insertion of the screws into the bores.
  • Fig. 26 is a view similar to Fig. 25 and illustrating an alternative configuration and placement of screws and bores .
  • Fig. 27 is a perspective view illustrating the device of Figs. 22A and 22B implanted between adjacent first and second spinous processes after insertion of screws into the bores and the incline planes raised.
  • Fig. 28 is a view similar to Fig. 25 and illustrating another alternative configuration and placement of screws and bores.
  • Fig. 29 is a view similar to Fig.
  • Fig. 30 is a side view of an alternative embodiment of a device that can be implanted by percutaneous access between adjacent first and second spinous processes of the stenotic vertebrea to relieve the pressure on the spinal cord and/or nerve roots and having a hinged mechanism and in which the angle of the inclined planes may be controlled by an enlargeable bladder.
  • Fig. 31 is an alternative embodiment of the device of Fig. 30.
  • Fig. 32 is a bottom plan view of the upper arm of an alternative embodiment of the device of Fig. 30 having left and right bladders .
  • Fig. 33 is a bottom plan view of the upper arm of an alternative embodiment of the device of Fig. 30 having anterior and posterior bladders .
  • Fig. 1 shows a vertebra with a normal neuroforamen.
  • Fig. 2 shows the passage of the spinal cord and nerve roots in a normal neuroforamen.
  • Fig. 3 shows a vertebra with a stenotic neuoforamen, i.e., a neuroforamen that has a reduced sized, compared to the neuroforaman shown in Fig. 1.
  • Fig. 4 shows, the narrowing of the spaces in the spine that results in pressure on the spinal cord and/or nerve roots. When the neuroforamina are reduced in size, the nerves may swell and become inflamed, causing pain and discomfort .
  • Fig. 1 shows a vertebra with a normal neuroforamen.
  • Fig. 2 shows the passage of the spinal cord and nerve roots in a normal neuroforamen.
  • Fig. 3 shows a vertebra with a stenotic neuoforamen, i.e., a neuroforamen that has a reduced sized, compared
  • FIG. 5 shows a device 10 that has been implanted by percutaneous access between adjacent first and second spinous processes of the stenotic vertebrea shown in Fig. 4.
  • the device 10 relieves the pressure on the spinal cord and/or nerve roots.
  • Fig. 6 shows the device 10 as it exists outside the body, prior to implantation.
  • the device 10 can be made of a durable prosthetic material, such as, e.g., polyethylene, rubber, a sponge material (e.g., polyethylene sponge), tantalum, titanium, chrome cobalt, surgical steel, bony in-growth material, ceramic, artificial bone, or a combination thereof.
  • the implanted device 10 includes a body 12 having a contact region 14 that, in use, rests between the first and second spinous processes (see Fig. 12) .
  • Fig. 12 As Fig. 12 best shows, the region 14, in use, engages both spinous processes to apply a separating force. The force spreads apart or distracts the spinous processes. The degree of distraction can be seen by comparing Fig. 5 (with distraction) with Fig. 4 (before distraction) . The distraction enlarges the volume of the spinal canal to alleviate pressure on blood vessels and/or nerves, thereby treating the pain and other symptoms that can accompany spinal stenosis.
  • the implanted device 10 also serves as an extension stop for the back. As the back is bent backwardly and placed in extension, the presence of the implanted device 10 resists extension beyond a given point.
  • the spacing between adjacent spinous processes cannot be reduced to less than the outside diameter of the body region 14.
  • the presence of the implanted device 10 can serve to block the last 4° to 5° of extension. Pressure on nerves and the resulting pain are therefore alleviated or reduced.
  • the device 10 can be implanted by non-invasive percutaneous access, instead of requiring an open surgical procedure.
  • a small incision e.g., 1 cm
  • a guide pin 16 is inserted through the incision.
  • the guide pin 16 Under imaging guidance (e.g., x-ray (fluoroscopy) , ultrasound, magnetic resonance, computed tomography, or combinations thereof) the guide pin 16 is inserted in between the adjacent spinous processes.
  • a first tubular obturator 18 is inserted over the guide pin 16 under imaging guidance into the space between the two spinous process (see Fig. 9) .
  • the outside diameter of the obturator 18 is selected to initiate distension of the spinous processes.
  • the first tubular obturator 18 is withdrawn over the guide pin 16, and a second tubular obturator 20 is inserted over the guide pin 16 under imaging guidance into the previously distended space between the spinous processes (see Fig. 10) .
  • the second tubular obturator 20 has a second outside diameter greater than the outside diameter of the first obturator 18, to open a greater distention of the spinous processes. This distension is slightly smaller than the outside diameter of the body region 14 of the device 10 to be implanted.
  • the second obturator 20 is then withdrawn over the guide pin 16. Additional (or fewer) obturators may be deployed in this manner until a desired degree of distension is achieved.
  • the device 10 is now inserted over the guide pin 16 under imaging guidance into the distended space between the spinous processes (Fig. 11) .
  • the body 12 of the device 10 includes an interior lumen 22 to accommodate its passage over the guide pin 16.
  • the body 12 of the device 10 can be sized and configured in various ways.
  • the body 12 can, e.g., be cylindrical, square, rectangular, or curvilinear (banana- shaped) .
  • the body 12 also desirably includes threaded lands 24, so that the device 10 functions as a screw.
  • a screw driving tool 26 passes over the guide pin 16 and engages the device 10 (Fig. 11) , to rotate the device 10 about the guide pin 16 and advance the device 10 between the spinous processes .
  • the threaded lands 24 take purchase in the bone of the spinous processes, to secure the device 10 in place between the distended spinous processes .
  • the tool 26 and guide pin 16 can now be withdrawn, leaving the implanted device 10 behind (Fig. 12) .
  • the incision is closed.
  • FIG. 13 shows an alternative embodiment of a device 28 that can be implanted by percutaneous access to cause distention between adjacent first and second spinous processes of stenotic vertebrea.
  • the device 28 includes a blunt nose 29 and a bullet-shaped body 30 having a stepped-down or notched region 32 between adjoining stepped-up or ridge regions 34.
  • the interior of the notched region 32 includes grooves, lands, or an otherwise roughened exterior surface to gain purchase in bone .
  • the body 30 can be made of a durable prosthetic material, such as, e.g., polyethylene, rubber, a sponge material (e.g., polyethylene sponge), tantalum, titanium, chrome cobalt, surgical steel, bony in-growth material, ceramic, artificial bone, or a combination thereof.
  • the body 30 includes a lumen 36 to accommodate passage of a guide pin 16, as will be described in greater detail later.
  • the body 30 measures about 9 mm in overall length, and the regions 32 and 34 are approximately equal in length (i.e., each being approximately 3mm in length) .
  • the outside diameter of the body 30 at the ridge regions 34 can be about 5mm to 6mm.
  • the depth of the notched region 32 can be about 2mm. If desired, there can be two, oppositely facing notched regions 32 (not shown) .
  • the device 28 is desirably implanted using a tool 40 that comprises a sleeve 42 carried at the end of a handle 38 and a pusher 44 that entends through the handle 38 into the sleeve 42.
  • the sleeve 42 accommodates insertion of the device 28, with its blunt distal end partially exposed.
  • the pusher 44 serves, in use, to push against the proximal end of the device 28 within the sleeve 42, to expel the device 28 from the sleeve 42.
  • the proximal end of the body 30 desirably includes a receptacle 46 in which the pusher 44, when in use, rests.
  • the pusher 44 includes a lumen 48 that accommodates passage of a guide pin 16, so the tool 40, like the device 28 can be percutaneously deployed.
  • the guide pin 16 and obturators 18 and 20 are manipulated under imaging guidance as previously described and shown in Figs. 7 to 10.
  • the tool 40, carrying the device 28 (the device 28 being preferably retracted, at least in part, within the sleeve 42) , is deployed over the guide pin 16 to a location adjacent the distended spinous processes.
  • the pusher 44 is advanced forward (see Fig.
  • Figs. 18A and 18B show an alternative embodiment of the device 28. Structural elements that are shared with the device 28 shown in Figs. 13 are designated by the same reference numbers. In Figs.
  • the device 28 includes a notched region 50, where the spinous process rests when the device 28 is installed.
  • the notched region 50 is tapered between a high surface 52 and a low surface 54.
  • the taper forms an angle ⁇ (shown in Figs. 18A and 18B) that is in the range of 4-degrees to 25-degrees from horizonal, which is gauged relative to the anterior-to- posterior orientation of the receptacle 46.
  • the interior of the notched region 50 can include grooves, lands, or otherwise roughened exterior surface to gain purchase in bone.
  • the device 28 is installed between adjacent first and second spinous processes of stenotic vertebrae (see Fig. 20) , such that the high surface 52 is oriented in an anterior direction - i.e., adjacent the disc - and the low surface 54 is oriented in a posterior direction - i.e., facing away from the vertebral body (see Fig. 21, also) .
  • the taper angle ⁇ of the notched region 50 is preferably selected to approximate the degree of the posterior curvature of the spinous process that settles within the notched region 50, to maximize contact between the notched region 50 and the spinous process throughout the notched region 50.
  • the degree of taper may be chosen to accommodate a specific location and/or individual anatomy.
  • the inferior side of the device 28 can also be notched in the same manner with a posterior-directed taper 52, so that spinous processes will settle into the superior and interior notched regions 50.
  • the guide pin 16 and obturators 18 and 20 are manipulated under imaging guidance as previously described and shown in Figs. 7 to 10.
  • the tool 40 carrying the device 28 (the device 28 being preferably retracted, at least in part, within the sleeve 42) , is deployed over the guide pin 16 to a location adjacent the distended spinous processes such that the tapered region 50 is oriented with the high surface 52 directed anteriorly and the low surface 54 directed posteriorly, as shown in Fig. 19.
  • the pusher 44 is then advanced forward to expel the device 28 from the sleeve 42, as previously described.
  • the blunt distal end 29 of the body 30 enters the distended space between the processes, distending them slightly more, until one (or both, depending upon the configuration) of the spinous processes settles within the notched region 50, as shown in Figs. 20 and 21.
  • Distraction of stenotic vertebrae may also be accomplished by placement of an enlargeable or expandable structure between adjacent first and second spinous processes .
  • the enlargeable structure may be selectively manipulated between a contracted condition suitable for percutaneous introduction between the spinous processes and an expanded or enlarged condition in which the expandable structure engages both spinous processes to apply a separating force to spread apart or distract the spinous processes .
  • the enlargeable structure may take various configurations suitable for percutaneous access and providing suitable distraction.
  • Fig. 22A shows a device 100 suitable for non- invasive insertion by percutaneous access and without requiring an open surgical procedure.
  • the device 100 provides a hinged arrangement that permits selective expansion of the device 100 to allow adjustment of incline planes to the desired angle for each interspinous process.
  • the device 100 has a contracted condition, shown in Fig. 23, suitable for percutaneous insertion between adjacent spinous processes and an expanded condition, shown in Fig. 24, in which the device 100 engages ' both spinous processes to apply a separating force to spread apart or distract the spinous processes.
  • the device 100 comprises a hinge 102, a top or first arm 104 and a bottom or second arm 106.
  • the arms 104 and 106 define an angle of taper ( ⁇ ) .
  • the arms may be selectively expanded to increase the angle ⁇ to a desired angle to accommodate the angle of adjacent spinous processes at a given location on the spinal column and to accommodate individual anatomy.
  • the device 100 is introduced in the contracted condition between adjacent first and second spinous processes of stenotic vertebrae such that the arms 104 and 106 are oriented in an anterior direction, i.e., adjacent the disc, and the hinge 102 is oriented in a posterior direction, i.e., facing away from the vertebral body.
  • the first arm 104 provides a first contact surface 108 that, upon expansion, engages the first spinous process.
  • the second arm 106 provides a second contact surface 110 that, upon expansion, engages the second spinous process.
  • the contact surfaces 108 and 110 may be essentially smooth, as seen in Fig. 22A. Alternatively, either or both of the contact surfaces 108 and 110 may be roughened or saw- toothed to provide a series of projections 111 in a manner that prevents slippage of the device, as seen in Fig. 22B.
  • the projections 111 may take any of a variety of configurations (e.g., ridges, teeth) . It is contemplated that the number, size, and configuration of the projections 111 may be varied as desired or as necessary to prevent slippage.
  • the device 100 can be made of a durable prosthetic material, such as, e.g., polyethylene, rubber, a sponge material (e.g., polyethylene sponge), tantalum, titanium, chrome cobalt, surgical steel, bony in-growth material, ceramic, artificial bone, or a combination thereof.
  • the device 100 may be inserted by percutaneous access as previously described and using suitable surgical tools.
  • the implanted device 100 also serves as an extension stop for the back and can serve to block the last 4° to 5°. Due to the presence of the implanted device 100, the spacing between adjacent spinous processes cannot be reduced to less than angle ⁇ . Pressure on nerves and the resulting pain are therefore alleviated or reduced.
  • a series of complementary and mating fixation members, e.g., screws, and fixation member receivers, e.g., holes or bores, allow for controlled expansion and independent right and left side adjustment to achieve desired inclined planes and thereby create the desired angle ⁇ for each interspinous process .
  • a first bore 112A extends in a lateral direction across the spinous processes (i.e., along an axis A and at approximately a 90-degree angle from the axis B of the device 100) from a first side 114 (i.e., the right side in Fig. 25) to a second side 116 (i.e, the left side in Fig.
  • the first bore 112A receives a first screw 118A, e.g., by threaded engagement.
  • the first screw has a body 120A that tapers medially from the first side 114 to the second side 116 from a larger diameter D2 to a smaller diameter D3.
  • D2 is greater than Dl (D2 > Dl) such that, upon insertion into the first bore 112A, the first screw 112A raises the first side 114
  • a second' bore 112B extends in a lateral direction and tapers in diameter medially from a larger diameter D4 to a smaller diameter D5.
  • the second bore 112B receives a second screw 118B e.g., by threaded engagement.
  • the second screw 118B has a body 120B of an essentially constant diameter (D6) .
  • D6 is greater than D5 (D6 > D5) , such that upon insertion into the second bore 112B, the second screw 118B raises the second (i.e., opposing) side 116 of the inclined plane formed by the first and second arms 104 and 106.
  • the screws may be formed of any suitable durable and biocompatible material, e.g., titanium, titanium alloys, tantalum, chrome cobalt, surgical steel, ceramic, sintered glass, artificial bone, or combinations thereof .
  • the size as well as the depth of insertion of the screws 118A and 118B can be selectively controlled to achieve the desired incline plane for a given location on the spinal ⁇ column and to accommodate individual anatomy.
  • the range of incline plane is adjustable from approximately 4- degrees to approximately 25-degrees from horizontal, which is gauged relative to the anterior-to-posterior orientation of the device 100.
  • the first and second screws 118A and 118B are inserted from the same side 114. In the embodiment illustrated in Fig.
  • both screws are inserted from the right or first side 114 such that the first screw 118A raises right side and the second screw 118B raises left or second side 116.
  • both the first and second screws 118A and 118B may be inserted from the opposing or left side 116, as shown in Fig. 26.
  • the first screw 118A raises the second or left side 116,while the second screw 118B raises the first or right side l ⁇ 4.
  • the first and second screws are inserted from opposite sides 114 and 116 respectively. In one embodiment, illustrated in Fig.
  • both the first and second bores 112A and 112B extend in a lateral direction and are of an essentially constant diameter Dl such that the bores 112A and 112B are generally parallel.
  • the first screw 118A is inserted from the first side 114 to raise the first side 114.
  • the second screw 118B is inserted from the second side 116 to raise the second side 116.
  • both of the first and second bores 112A and 112B extend in a lateral direction and taper in diameter medially from a larger diameter D4 to a smaller diameter D5.
  • the first bore 112A tapers medially from the first side 114 toward the second side 116.
  • the second bore 112B tapers medially from the second side 116 toward the first side 114.
  • Both of the first and second screws 118A and 118B have a body 120A and 120B, respectively, of an essentially constant diameter D6.
  • the first screw 118A is inserted from the first side 114 to raise the second (i.e., opposite) side 116.
  • the second screw 118B is inserted the second side 116 to raise the first (i.e., opposite) side 114. It will be readily apparent to one of skill in the art in view of this disclosure that the number, configuration, and placement of screws 118 and bores 112 may be varied to accommodate specific needs as well as to accommodate individual anatomy.
  • an enlargeable container is used to displace or raise the arms 104 and 106 and thereby increase the inclined planes to _the desired angle ⁇ .
  • Fig. 30 illustrates an alternative embodiment of a device 200 suitable for non-invasive insertion by percutaneous access and without requiring an open surgical procedure.
  • the device 200 has a hinged arrangement and shares features of the device 100 previously described. Therefore, like reference numbers will be assigned to denote like parts.
  • a bladder 202 may be inserted between the arms 104 and 106 and expanded or inflated, e.g., by bone cement, to raise the arms 104 and 106 to the desired inclined planes.
  • the bladder 202 may be formed integral with the device 202.
  • the device 200 is inserted between adjacent spinous processes as previously described with the bladder 202 in the contracted condition.
  • the bladder 202 may include an injection port 204 for introducing bone cement or other medium into the bladder 202 to enlarge the bladder 202.
  • the degree of expansion of the bladder 202 may be selectively controlled and is desirably uniform in the medial-lateral direction to provide equivalent right and left side distraction.
  • the arm 104 includes an inflation port 204 that communicates with the bladder 202 through a lumen 206 to permit introduction of a medium into the bladder 202.
  • the bladder 202 may be a separate component from the device 200.
  • the device 202 is first inserted between adjacent spinous processes as previously described.
  • the bladder 202 is then inserted in the contracted condition and positioned between arms 104 and 106.
  • a medium is then injected or otherwise introduced into the bladder
  • bladders 202 to enlarge the bladder 202, as previously described. It is contemplated that multiple bladders 202 can be used, e.g., left and right bladders 202 (Fig. 32), or anterior and posterior bladders (Fig. 33) . Desirably, the bladders 202 may be enlarged independently, e.g. by distinct inflation ports 204, to selectively control the degree of enlargement of each bladder 202 to produce the desired angle ⁇ . It is further contemplated that the bladders 202 may be of varying size and configuration as desired to accommodate specific needs and individual anatomy. Other embodiments and uses of the inventions described herein will be apparent to those skilled in the art from consideration of the specification and practice of the inventions disclosed. All documents referenced herein are specifically and entirely incorporated by reference.

Abstract

Systems and methods for treating spinal stenosis insert a guide element percutaneously into proximity with the adjacent spinous processes. The systems and methods direct an implant device over the guide element to a position resting between the adjacent spinous processes. The device is sized and configured to distend the adjacent spinous processes. The implant device itself can be variously constructed. It can, e.g., possess threaded lands and/or a notched region in which a spinous process can rest. The implant device has a lumen to accommodate passage of the guide element, so that the device can be passed percutaneously over the guide element for implantation between adjacent spinous processes.

Description

PERCUTANEOUS SPINE DISTRACTION IMPLANT SYSTEMS AND METHODS Related Applications This application claims the benefit of provisional U.S. Application Serial No. 60/539,208, filed January 26, 2004, and provisional U.S. Application Serial No. 60/600,039, filed August 9, 2004. Field of the Invention The invention generally relates to systems and methods for treating conditions of the spine, and, in particular, systems and methods for distending the spine and/or blocking and/or limiting spinal extension for treating, e.g., spinal stenosis. Background of the Invention , Spinal stenosis is a narrowing of the spinal canal . The narrowing of the spinal canal itself does not usually cause any symptoms. However, symptoms such as pain, weakness, and/or numbness appear when the narrowing leads to compression of the spinal cord and nerve roots . The nerves react by swelling and undergoing inflammation. While spinal stenosis can be found in any part of the spine, the lumbar and cervical areas are the most commonly affected. Patients with lumbar spinal stenosis may feel pain, weakness, or numbness in the legs, calves or buttocks. In the lumbar spine, symptoms often increase when walking short distances and decrease when the patient sits, bends forward or lies down. Cervical spinal stenosis may cause similar symptoms in- the shoulders, arms, and legs; hand clumsiness and gait and balance disturbances can also occur. In some patients the pain starts in the legs and moves upward to the buttocks; in other patients the pain begins higher in the body and moves downward. The pain may radiate or may be a cramping pain. In severe cases, the pain can be constant, excruciating, and debilitating. Some people are born with spinal stenosis. Typically, however, spinal stenosis occurs as the gradual result of aging and "wear and tear" on the spine during everyday activities. The incidence of spinal stenosis increases as people exceed 50 years of age. Stenosis can sometimes be treated without surgery, e.g., through the use of medications, steroid injections, rest or restricted activity, or physical therapy. In cases when non-surgical treatments are not effective, surgical treatments can be performed, e.g., decompressive laminectomy, laminotomy, foraminotomy, cervical discectomy and fusion, cervical corpectomy, and laminoplasty. The use of surgically implanted devices that distract the spine, called the X-Bar, has also been advocated, e.g., as disclosed in United States Patent 6,451,020. These surgical techniques, though effective for many, are invasive. They require exposure of a section of the spine through an open incision, approximately two inches in length, made along the midline of the back, for excision of vertebral lamina or the placement of an implant between adjacent spinous processes. Due to the obvious risks involved, many surgeons will not consider open surgical treatment of spinal stenosis unless several months of non-surgical treatment methods have been tried. Summary of the Invention The present invention overcomes the problems and disadvantages associated with current strategies and systems in the treatment of spinal stenosis by invasive, open surgical procedures. One aspect of the invention provides systems and methods for treating spinal stenosis. The systems and methods direct an implant device to a position resting between the adjacent spinous processes. The device is sized and configured to distend the adjacent spinous processes. The device can also block or limit extension of the back. The device includes a region that, in use, receives a spinous process. The region tapers from a high surface to a low surface in an anterior-to-posterior direction. Other objects, advantages, and embodiments of the invention are set forth in part in the description which follows, and in part, will be obvious from this description, or may be learned from the practice of the invention. Description of the Drawings Fig. 1 shows a vertebra with a normal neuroforamen. Fig. 2 shows the passage of the spinal cord and nerve roots in a normal neuroforamen. Fig. 3 shows a vertebra with a stenotic neuoforamen, i.e., a neuroforamen that has a reduced sized, compared to the neuroforaman shown in Fig. 1. Fig. 4 shows the narrowing of the spaces in the spine that results in pressure on the spinal cord and/or nerve roots, causing nerves to swell and become inflamed. Fig. 5 shows a device that has been implanted by percutaneous access between adjacent first and second spinous processes of the stenotic vertebrae shown in Fig. 4 to relieve the pressure on the spinal cord and/or nerve roots . Fig. 6 shows the device shown in Fig. 5 as it exists outside the body, prior to implantation. Figs . 7 to 12 show the implantation of the device shown in Fig. 6 by percutaneous access. Fig. 13 shows an alternative embodiment of a device that can be implanted by percutaneous access between adjacent first and second spinous processes of the stenotic vertebrea to relieve the pressure on the spinal cord and/or nerve roots . Figs. 14 to 16 show the implantation of the device shown in Fig. 13 by percutaneous access. Fig. 17 shows the device shown in Fig. 13 after implantation. Fig. 18A shows an alternative embodiment of a device that can be implanted by percutaneous access between adjacent first and second spinous processes of the stenotic vertebrea to relieve the pressure on the spinal cord and/or nerve roots . Fig. 18B is a section view of the device taken generally along line 18B-18B in Fig. 18A. Fig. 19 shows the implantation of the device shown in Fig. 18A by percutaneous access. Fig. 20 shows the device shown in Fig. 18A after implantation. Fig. 21 is a section view of the device taken generally along line 21-21 in Fig. 20. Figs . 22A and 22B are perspective views of an alternative embodiment of a device that can be implanted by percutaneous access between adjacent first and second spinous processes of the stenotic vertebrea to relieve the pressure on the spinal cord and/or nerve roots and having a hinge mechanism and in which the angle of the inclined planes may be controlled by a series of screws and bores . Fig. 23 is a side view of the device of Figs. 22A and 22B implanted between adjacent first and second spinous processes of the stenotic vertebrae and in a contracted condition. Fig. 24 is a side view similar to Fig. 23 and illustrating the device in an enlarged condition which relieves pressure on the spinal cord and/or nerve roots. Fig. 25 is a top plan view of the bottom arm of the device of Figs. 22A and 22B illustrating a configuration and placement of screws and bores which serves to raise the incline planes of the device upon insertion of the screws into the bores. Fig. 26 is a view similar to Fig. 25 and illustrating an alternative configuration and placement of screws and bores . Fig. 27 is a perspective view illustrating the device of Figs. 22A and 22B implanted between adjacent first and second spinous processes after insertion of screws into the bores and the incline planes raised. Fig. 28 is a view similar to Fig. 25 and illustrating another alternative configuration and placement of screws and bores. Fig. 29 is a view similar to Fig. 25 and illustrating another alternative configuration and placement of screws and bores . Fig. 30 is a side view of an alternative embodiment of a device that can be implanted by percutaneous access between adjacent first and second spinous processes of the stenotic vertebrea to relieve the pressure on the spinal cord and/or nerve roots and having a hinged mechanism and in which the angle of the inclined planes may be controlled by an enlargeable bladder. Fig. 31 is an alternative embodiment of the device of Fig. 30. Fig. 32 is a bottom plan view of the upper arm of an alternative embodiment of the device of Fig. 30 having left and right bladders . Fig. 33 is a bottom plan view of the upper arm of an alternative embodiment of the device of Fig. 30 having anterior and posterior bladders . Description of the Preferred Embodiment Fig. 1 shows a vertebra with a normal neuroforamen. Fig. 2 shows the passage of the spinal cord and nerve roots in a normal neuroforamen. Fig. 3 shows a vertebra with a stenotic neuoforamen, i.e., a neuroforamen that has a reduced sized, compared to the neuroforaman shown in Fig. 1. As Fig. 4 shows, the narrowing of the spaces in the spine that results in pressure on the spinal cord and/or nerve roots. When the neuroforamina are reduced in size, the nerves may swell and become inflamed, causing pain and discomfort . Fig. 5 shows a device 10 that has been implanted by percutaneous access between adjacent first and second spinous processes of the stenotic vertebrea shown in Fig. 4. The device 10 relieves the pressure on the spinal cord and/or nerve roots. Fig. 6 shows the device 10 as it exists outside the body, prior to implantation. The device 10 can be made of a durable prosthetic material, such as, e.g., polyethylene, rubber, a sponge material (e.g., polyethylene sponge), tantalum, titanium, chrome cobalt, surgical steel, bony in-growth material, ceramic, artificial bone, or a combination thereof. The implanted device 10 includes a body 12 having a contact region 14 that, in use, rests between the first and second spinous processes (see Fig. 12) . As Fig. 12 best shows, the region 14, in use, engages both spinous processes to apply a separating force. The force spreads apart or distracts the spinous processes. The degree of distraction can be seen by comparing Fig. 5 (with distraction) with Fig. 4 (before distraction) . The distraction enlarges the volume of the spinal canal to alleviate pressure on blood vessels and/or nerves, thereby treating the pain and other symptoms that can accompany spinal stenosis. In use, the implanted device 10 also serves as an extension stop for the back. As the back is bent backwardly and placed in extension, the presence of the implanted device 10 resists extension beyond a given point. Due to the presence of the implanted device 10, the spacing between adjacent spinous processes cannot be reduced to less than the outside diameter of the body region 14. Typically, given an outside diameter of between 5 mm to 14 mm, the presence of the implanted device 10 can serve to block the last 4° to 5° of extension. Pressure on nerves and the resulting pain are therefore alleviated or reduced. Significantly, the device 10 can be implanted by non-invasive percutaneous access, instead of requiring an open surgical procedure. As Fig. 7 shows, a small incision, e.g., 1 cm, is desirably made about 8 cm to 10 cm from the midline of the back. With reference to Fig. 8, a guide pin 16 is inserted through the incision. Under imaging guidance (e.g., x-ray (fluoroscopy) , ultrasound, magnetic resonance, computed tomography, or combinations thereof) the guide pin 16 is inserted in between the adjacent spinous processes. A first tubular obturator 18 is inserted over the guide pin 16 under imaging guidance into the space between the two spinous process (see Fig. 9) . The outside diameter of the obturator 18 is selected to initiate distension of the spinous processes. The first tubular obturator 18 is withdrawn over the guide pin 16, and a second tubular obturator 20 is inserted over the guide pin 16 under imaging guidance into the previously distended space between the spinous processes (see Fig. 10) . The second tubular obturator 20 has a second outside diameter greater than the outside diameter of the first obturator 18, to open a greater distention of the spinous processes. This distension is slightly smaller than the outside diameter of the body region 14 of the device 10 to be implanted. The second obturator 20 is then withdrawn over the guide pin 16. Additional (or fewer) obturators may be deployed in this manner until a desired degree of distension is achieved. The device 10 is now inserted over the guide pin 16 under imaging guidance into the distended space between the spinous processes (Fig. 11) . As Fig. 6 shows, the body 12 of the device 10 includes an interior lumen 22 to accommodate its passage over the guide pin 16. The body 12 of the device 10 can be sized and configured in various ways. The body 12 can, e.g., be cylindrical, square, rectangular, or curvilinear (banana- shaped) . The body 12 also desirably includes threaded lands 24, so that the device 10 functions as a screw. A screw driving tool 26 passes over the guide pin 16 and engages the device 10 (Fig. 11) , to rotate the device 10 about the guide pin 16 and advance the device 10 between the spinous processes . The threaded lands 24 take purchase in the bone of the spinous processes, to secure the device 10 in place between the distended spinous processes . The tool 26 and guide pin 16 can now be withdrawn, leaving the implanted device 10 behind (Fig. 12) . The incision is closed. The implantation of the device 10 has been completed percutaneously and without need of an open surgical procedure. Fig. 13 shows an alternative embodiment of a device 28 that can be implanted by percutaneous access to cause distention between adjacent first and second spinous processes of stenotic vertebrea. The device 28 includes a blunt nose 29 and a bullet-shaped body 30 having a stepped-down or notched region 32 between adjoining stepped-up or ridge regions 34. Desirably, the interior of the notched region 32 includes grooves, lands, or an otherwise roughened exterior surface to gain purchase in bone . Like the body 12 , the body 30 can be made of a durable prosthetic material, such as, e.g., polyethylene, rubber, a sponge material (e.g., polyethylene sponge), tantalum, titanium, chrome cobalt, surgical steel, bony in-growth material, ceramic, artificial bone, or a combination thereof. Also like the body 12, the body 30 includes a lumen 36 to accommodate passage of a guide pin 16, as will be described in greater detail later. In a typical embodiment, the body 30 measures about 9 mm in overall length, and the regions 32 and 34 are approximately equal in length (i.e., each being approximately 3mm in length) . The outside diameter of the body 30 at the ridge regions 34 can be about 5mm to 6mm. The depth of the notched region 32 can be about 2mm. If desired, there can be two, oppositely facing notched regions 32 (not shown) . As Fig. 14 shows, the device 28 is desirably implanted using a tool 40 that comprises a sleeve 42 carried at the end of a handle 38 and a pusher 44 that entends through the handle 38 into the sleeve 42. The sleeve 42 accommodates insertion of the device 28, with its blunt distal end partially exposed. The pusher 44 serves, in use, to push against the proximal end of the device 28 within the sleeve 42, to expel the device 28 from the sleeve 42. The proximal end of the body 30 desirably includes a receptacle 46 in which the pusher 44, when in use, rests. The pusher 44 includes a lumen 48 that accommodates passage of a guide pin 16, so the tool 40, like the device 28 can be percutaneously deployed. In use, the guide pin 16 and obturators 18 and 20 are manipulated under imaging guidance as previously described and shown in Figs. 7 to 10. At this point in the procedure (see Fig. 15), the tool 40, carrying the device 28 (the device 28 being preferably retracted, at least in part, within the sleeve 42) , is deployed over the guide pin 16 to a location adjacent the distended spinous processes. The pusher 44 is advanced forward (see Fig. 16), to expel the device 28 from the sleeve 42. The blunt distal end of the body 30 enters the distended space between the processes, distending them slightly more, until one of the spinous processes settles within the notched region 32 (see Fig. 17) (if two notched regions are present, both spinous processes will settle into its own notched region) . The tool 40 is withdrawn back over the guide pin 16. The guide pin 16 is removed, leaving the device 28 resting between the two spinous processes. The incision is closed. The percutaneous implantation of the device 28 has been completed. Figs. 18A and 18B show an alternative embodiment of the device 28. Structural elements that are shared with the device 28 shown in Figs. 13 are designated by the same reference numbers. In Figs. 18A and 18B, the device 28 includes a notched region 50, where the spinous process rests when the device 28 is installed. Unlike the notched region 32 in Fig. 13, the notched region 50 is tapered between a high surface 52 and a low surface 54. In a representative embodiment, the taper forms an angle α (shown in Figs. 18A and 18B) that is in the range of 4-degrees to 25-degrees from horizonal, which is gauged relative to the anterior-to- posterior orientation of the receptacle 46. If desired, there can be two, oppositely facing notched tapered notched regions 32 (not shown) . As with the notched region 32, the interior of the notched region 50 can include grooves, lands, or otherwise roughened exterior surface to gain purchase in bone. In use, the device 28 is installed between adjacent first and second spinous processes of stenotic vertebrae (see Fig. 20) , such that the high surface 52 is oriented in an anterior direction - i.e., adjacent the disc - and the low surface 54 is oriented in a posterior direction - i.e., facing away from the vertebral body (see Fig. 21, also) . The taper angle α of the notched region 50 is preferably selected to approximate the degree of the posterior curvature of the spinous process that settles within the notched region 50, to maximize contact between the notched region 50 and the spinous process throughout the notched region 50. The degree of taper may be chosen to accommodate a specific location and/or individual anatomy. The inferior side of the device 28 can also be notched in the same manner with a posterior-directed taper 52, so that spinous processes will settle into the superior and interior notched regions 50. To install, the guide pin 16 and obturators 18 and 20 are manipulated under imaging guidance as previously described and shown in Figs. 7 to 10. The tool 40, carrying the device 28 (the device 28 being preferably retracted, at least in part, within the sleeve 42) , is deployed over the guide pin 16 to a location adjacent the distended spinous processes such that the tapered region 50 is oriented with the high surface 52 directed anteriorly and the low surface 54 directed posteriorly, as shown in Fig. 19. The pusher 44 is then advanced forward to expel the device 28 from the sleeve 42, as previously described. The blunt distal end 29 of the body 30 enters the distended space between the processes, distending them slightly more, until one (or both, depending upon the configuration) of the spinous processes settles within the notched region 50, as shown in Figs. 20 and 21. Distraction of stenotic vertebrae may also be accomplished by placement of an enlargeable or expandable structure between adjacent first and second spinous processes . The enlargeable structure may be selectively manipulated between a contracted condition suitable for percutaneous introduction between the spinous processes and an expanded or enlarged condition in which the expandable structure engages both spinous processes to apply a separating force to spread apart or distract the spinous processes . The enlargeable structure may take various configurations suitable for percutaneous access and providing suitable distraction. By way of example and not limitation, a representative embodiment will now be described. Fig. 22A shows a device 100 suitable for non- invasive insertion by percutaneous access and without requiring an open surgical procedure. The device 100 provides a hinged arrangement that permits selective expansion of the device 100 to allow adjustment of incline planes to the desired angle for each interspinous process. The device 100 has a contracted condition, shown in Fig. 23, suitable for percutaneous insertion between adjacent spinous processes and an expanded condition, shown in Fig. 24, in which the device 100 engages' both spinous processes to apply a separating force to spread apart or distract the spinous processes. As Figs. 22A shows, the device 100 comprises a hinge 102, a top or first arm 104 and a bottom or second arm 106. The arms 104 and 106 define an angle of taper (β) . The arms may be selectively expanded to increase the angle β to a desired angle to accommodate the angle of adjacent spinous processes at a given location on the spinal column and to accommodate individual anatomy. With reference to Fig. 23, the device 100 is introduced in the contracted condition between adjacent first and second spinous processes of stenotic vertebrae such that the arms 104 and 106 are oriented in an anterior direction, i.e., adjacent the disc, and the hinge 102 is oriented in a posterior direction, i.e., facing away from the vertebral body. As best seen in Fig. 24, the first arm 104 provides a first contact surface 108 that, upon expansion, engages the first spinous process. The second arm 106 provides a second contact surface 110 that, upon expansion, engages the second spinous process. The contact surfaces 108 and 110 may be essentially smooth, as seen in Fig. 22A. Alternatively, either or both of the contact surfaces 108 and 110 may be roughened or saw- toothed to provide a series of projections 111 in a manner that prevents slippage of the device, as seen in Fig. 22B. The projections 111 may take any of a variety of configurations (e.g., ridges, teeth) . It is contemplated that the number, size, and configuration of the projections 111 may be varied as desired or as necessary to prevent slippage. The device 100 can be made of a durable prosthetic material, such as, e.g., polyethylene, rubber, a sponge material (e.g., polyethylene sponge), tantalum, titanium, chrome cobalt, surgical steel, bony in-growth material, ceramic, artificial bone, or a combination thereof. The device 100 may be inserted by percutaneous access as previously described and using suitable surgical tools. In use, the implanted device 100 also serves as an extension stop for the back and can serve to block the last 4° to 5°. Due to the presence of the implanted device 100, the spacing between adjacent spinous processes cannot be reduced to less than angle β. Pressure on nerves and the resulting pain are therefore alleviated or reduced. A series of complementary and mating fixation members, e.g., screws, and fixation member receivers, e.g., holes or bores, allow for controlled expansion and independent right and left side adjustment to achieve desired inclined planes and thereby create the desired angle β for each interspinous process . In a representative embodiment illustrated in Fig. 25, a first bore 112A extends in a lateral direction across the spinous processes (i.e., along an axis A and at approximately a 90-degree angle from the axis B of the device 100) from a first side 114 (i.e., the right side in Fig. 25) to a second side 116 (i.e, the left side in Fig. 25) of the device 100 and is of an essentially constant diameter (Dl) . The first bore 112A receives a first screw 118A, e.g., by threaded engagement. The first screw has a body 120A that tapers medially from the first side 114 to the second side 116 from a larger diameter D2 to a smaller diameter D3. D2 is greater than Dl (D2 > Dl) such that, upon insertion into the first bore 112A, the first screw 112A raises the first side 114
(i.e., the side of insertion) of the inclined plane formed by the first and second arms 104 and 106 (see also Fig. 27) . A second' bore 112B extends in a lateral direction and tapers in diameter medially from a larger diameter D4 to a smaller diameter D5. The second bore 112B receives a second screw 118B e.g., by threaded engagement. The second screw 118B has a body 120B of an essentially constant diameter (D6) . D6 is greater than D5 (D6 > D5) , such that upon insertion into the second bore 112B, the second screw 118B raises the second (i.e., opposing) side 116 of the inclined plane formed by the first and second arms 104 and 106. The screws may be formed of any suitable durable and biocompatible material, e.g., titanium, titanium alloys, tantalum, chrome cobalt, surgical steel, ceramic, sintered glass, artificial bone, or combinations thereof . The size as well as the depth of insertion of the screws 118A and 118B can be selectively controlled to achieve the desired incline plane for a given location on the spinal column and to accommodate individual anatomy. In a representative embodiment, the range of incline plane is adjustable from approximately 4- degrees to approximately 25-degrees from horizontal, which is gauged relative to the anterior-to-posterior orientation of the device 100. In this arrangement, the first and second screws 118A and 118B are inserted from the same side 114. In the embodiment illustrated in Fig. 25, both screws are inserted from the right or first side 114 such that the first screw 118A raises right side and the second screw 118B raises left or second side 116. Alternatively, both the first and second screws 118A and 118B may be inserted from the opposing or left side 116, as shown in Fig. 26. In this embodiment, the first screw 118A raises the second or left side 116,while the second screw 118B raises the first or right side lι4. In alternative embodiments, the first and second screws are inserted from opposite sides 114 and 116 respectively. In one embodiment, illustrated in Fig. 28, both the first and second bores 112A and 112B extend in a lateral direction and are of an essentially constant diameter Dl such that the bores 112A and 112B are generally parallel. The bodies 120A and 12OB of the first and second screws 118A and 118B, respectively, taper medially from a larger diameter D2 to a smaller diameter D3. The first screw 118A is inserted from the first side 114 to raise the first side 114. The second screw 118B is inserted from the second side 116 to raise the second side 116. In another embodiment, illustrated in Fig. 29, both of the first and second bores 112A and 112B extend in a lateral direction and taper in diameter medially from a larger diameter D4 to a smaller diameter D5. The first bore 112A tapers medially from the first side 114 toward the second side 116. The second bore 112B tapers medially from the second side 116 toward the first side 114. Both of the first and second screws 118A and 118B have a body 120A and 120B, respectively, of an essentially constant diameter D6. The first screw 118A is inserted from the first side 114 to raise the second (i.e., opposite) side 116. The second screw 118B is inserted the second side 116 to raise the first (i.e., opposite) side 114. It will be readily apparent to one of skill in the art in view of this disclosure that the number, configuration, and placement of screws 118 and bores 112 may be varied to accommodate specific needs as well as to accommodate individual anatomy. In other alternative embodiments, an enlargeable container is used to displace or raise the arms 104 and 106 and thereby increase the inclined planes to _the desired angle β. For example, Fig. 30 illustrates an alternative embodiment of a device 200 suitable for non-invasive insertion by percutaneous access and without requiring an open surgical procedure. The device 200 has a hinged arrangement and shares features of the device 100 previously described. Therefore, like reference numbers will be assigned to denote like parts. In the illustrated embodiment, a bladder 202 may be inserted between the arms 104 and 106 and expanded or inflated, e.g., by bone cement, to raise the arms 104 and 106 to the desired inclined planes. The bladder 202 may be formed integral with the device 202. The device 200 is inserted between adjacent spinous processes as previously described with the bladder 202 in the contracted condition. As shown in Fig. 30, the bladder 202 may include an injection port 204 for introducing bone cement or other medium into the bladder 202 to enlarge the bladder 202. The degree of expansion of the bladder 202 may be selectively controlled and is desirably uniform in the medial-lateral direction to provide equivalent right and left side distraction. In another embodiment, illustrated in Fig. 31, the arm 104 includes an inflation port 204 that communicates with the bladder 202 through a lumen 206 to permit introduction of a medium into the bladder 202. Alternatively, the bladder 202 may be a separate component from the device 200. In this arrangement, the device 202 is first inserted between adjacent spinous processes as previously described. The bladder 202 is then inserted in the contracted condition and positioned between arms 104 and 106. A medium is then injected or otherwise introduced into the bladder
202 to enlarge the bladder 202, as previously described. It is contemplated that multiple bladders 202 can be used, e.g., left and right bladders 202 (Fig. 32), or anterior and posterior bladders (Fig. 33) . Desirably, the bladders 202 may be enlarged independently, e.g. by distinct inflation ports 204, to selectively control the degree of enlargement of each bladder 202 to produce the desired angle β. It is further contemplated that the bladders 202 may be of varying size and configuration as desired to accommodate specific needs and individual anatomy. Other embodiments and uses of the inventions described herein will be apparent to those skilled in the art from consideration of the specification and practice of the inventions disclosed. All documents referenced herein are specifically and entirely incorporated by reference. The specification should be considered exemplary only with the true scope and spirit of the invention indicated by the following claims. As will be easily understood by those of ordinary skill in the art, variations and modifications of each of the disclosed embodiments can be easily made within the scope of this invention as defined by the following claims .

Claims

I Claim: 1. An implant device for distending adjacent spinous processes comprising a body sized and configured to rest between and distend the adjacent spinous processes, the body including inclined planes that taper from a superior surface to an inferior surface in an anterior-to- posterior direction. 2. A device according to claim 1, further including a lumen in the body sized and configured to accommodate passage of a percutaneous guide element . 3. A device according to claim 1 wherein the inclined planes define a region that is sized and configured to receive a spinous process . 4. A device according to claim 3 wherein the region has a taper angle in the range of 4-25° . 5. A device according to claim 3 wherein the region includes a surface sized and configured to frictionally engage bone. 6. A device according to claim 1 wherein the body is made of at least one selected prosthetic material. 7. A device according to claim 6 wherein the selected prosthetic material includes polyethylene, rubber, tantalum, titanium, chrome cobalt, surgical steel, bony in-growth material, ceramic, artificial bone, or a combination thereof. 8. A device according to claim 1, further including a tool sized and configured to engage the device and urge the device into a position resting between the adjacent spinous processes, the tool including a lumen accommodating passage of a guide element . 9. A device according to claim 1 wherein the body comprises a hinge mechanism and first and second arms coupled to the hinge mechanism which define an angle of taper. 10. A device according to claim 9 wherein the arms have a contracted condition permitting insertion of the device between adjacent spinous processes and an enlarged condition which distends the adjacent spinous processes. 11. A device according to claim 10 wherein the arms define an angle of taper selectively adjustable between 4-25°. 12. A device according to claim 10, further comprising means for moving the arms from the contracted position to the enlarged condition to increase the angle of taper. 13. A device according to claim 10, further comprising a fixation member which engages a fixation member receiver to move the arms from the contracted position to the enlarged condition to increase the angle of taper. 14. A device, according to claim 10, further comprising a bladder adapted to receive an enlarging medium which enlarges the bladder to move the arms from the contracted position to the enlarged condition to increase the angle of taper. 15. A device according to claim 14 wherein the enlarging medium is bone cement . 16. A method for treating spinal stenosis comprising directing a device as defined in claim 1 to a position resting between the adjacent spinous processes, the device being sized and configured to distend the adjacent spinous processes.
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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007018114A1 (en) 2005-08-11 2007-02-15 National University Corporation Kobe University Minimally-invasive implant for opening and enlargement of processus spinosus interspace and method of percutaneously enlarging processus spinosus interspace therewith
EP1807012A2 (en) * 2004-10-25 2007-07-18 Robert E. Lins Interspinous distraction devices and associated methods of insertion
GB2436293A (en) * 2006-03-24 2007-09-26 Galley Geoffrey H Spinous processes insertion device
EP1850799A2 (en) * 2005-02-04 2007-11-07 Nuvasive, Inc. Methods and apparatus for treating spinal stenosis
JP2011502573A (en) * 2007-11-02 2011-01-27 ランクス インコーポレイテッド Spine implant and method

Families Citing this family (246)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6068630A (en) * 1997-01-02 2000-05-30 St. Francis Medical Technologies, Inc. Spine distraction implant
US20080039859A1 (en) 1997-01-02 2008-02-14 Zucherman James F Spine distraction implant and method
US8128661B2 (en) * 1997-01-02 2012-03-06 Kyphon Sarl Interspinous process distraction system and method with positionable wing and method
US6712819B2 (en) * 1998-10-20 2004-03-30 St. Francis Medical Technologies, Inc. Mating insertion instruments for spinal implants and methods of use
US7959652B2 (en) 2005-04-18 2011-06-14 Kyphon Sarl Interspinous process implant having deployable wings and method of implantation
US5836948A (en) * 1997-01-02 1998-11-17 Saint Francis Medical Technologies, Llc Spine distraction implant and method
US7201751B2 (en) * 1997-01-02 2007-04-10 St. Francis Medical Technologies, Inc. Supplemental spine fixation device
US20080027552A1 (en) * 1997-01-02 2008-01-31 Zucherman James F Spine distraction implant and method
US20080071378A1 (en) * 1997-01-02 2008-03-20 Zucherman James F Spine distraction implant and method
US7306628B2 (en) 2002-10-29 2007-12-11 St. Francis Medical Technologies Interspinous process apparatus and method with a selectably expandable spacer
US20080086212A1 (en) 1997-01-02 2008-04-10 St. Francis Medical Technologies, Inc. Spine distraction implant
FR2828398B1 (en) * 2001-08-08 2003-09-19 Jean Taylor VERTEBRA STABILIZATION ASSEMBLY
US6793678B2 (en) 2002-06-27 2004-09-21 Depuy Acromed, Inc. Prosthetic intervertebral motion disc having dampening
FR2844179B1 (en) 2002-09-10 2004-12-03 Jean Taylor POSTERIOR VERTEBRAL SUPPORT KIT
US20060064165A1 (en) * 2004-09-23 2006-03-23 St. Francis Medical Technologies, Inc. Interspinous process implant including a binder and method of implantation
US8048117B2 (en) 2003-05-22 2011-11-01 Kyphon Sarl Interspinous process implant and method of implantation
US7931674B2 (en) * 2005-03-21 2011-04-26 Kyphon Sarl Interspinous process implant having deployable wing and method of implantation
US8147548B2 (en) * 2005-03-21 2012-04-03 Kyphon Sarl Interspinous process implant having a thread-shaped wing and method of implantation
US7909853B2 (en) 2004-09-23 2011-03-22 Kyphon Sarl Interspinous process implant including a binder and method of implantation
US8070778B2 (en) 2003-05-22 2011-12-06 Kyphon Sarl Interspinous process implant with slide-in distraction piece and method of implantation
US20050075634A1 (en) * 2002-10-29 2005-04-07 Zucherman James F. Interspinous process implant with radiolucent spacer and lead-in tissue expander
US7549999B2 (en) * 2003-05-22 2009-06-23 Kyphon Sarl Interspinous process distraction implant and method of implantation
US20080021468A1 (en) * 2002-10-29 2008-01-24 Zucherman James F Interspinous process implants and methods of use
US7833246B2 (en) * 2002-10-29 2010-11-16 Kyphon SÀRL Interspinous process and sacrum implant and method
US7335203B2 (en) 2003-02-12 2008-02-26 Kyphon Inc. System and method for immobilizing adjacent spinous processes
US7585316B2 (en) * 2004-05-21 2009-09-08 Warsaw Orthopedic, Inc. Interspinous spacer
US7651496B2 (en) * 2004-07-23 2010-01-26 Zimmer Spine, Inc. Methods and apparatuses for percutaneous implant delivery
US8470004B2 (en) 2004-08-09 2013-06-25 Si-Bone Inc. Apparatus, systems, and methods for stabilizing a spondylolisthesis
US20060036251A1 (en) 2004-08-09 2006-02-16 Reiley Mark A Systems and methods for the fixation or fusion of bone
US8444693B2 (en) 2004-08-09 2013-05-21 Si-Bone Inc. Apparatus, systems, and methods for achieving lumbar facet fusion
US8414648B2 (en) 2004-08-09 2013-04-09 Si-Bone Inc. Apparatus, systems, and methods for achieving trans-iliac lumbar fusion
US9662158B2 (en) 2004-08-09 2017-05-30 Si-Bone Inc. Systems and methods for the fixation or fusion of bone at or near a sacroiliac joint
US8425570B2 (en) 2004-08-09 2013-04-23 Si-Bone Inc. Apparatus, systems, and methods for achieving anterior lumbar interbody fusion
US20180228621A1 (en) 2004-08-09 2018-08-16 Mark A. Reiley Apparatus, systems, and methods for the fixation or fusion of bone
US8388667B2 (en) * 2004-08-09 2013-03-05 Si-Bone, Inc. Systems and methods for the fixation or fusion of bone using compressive implants
US9949843B2 (en) 2004-08-09 2018-04-24 Si-Bone Inc. Apparatus, systems, and methods for the fixation or fusion of bone
US7854752B2 (en) * 2004-08-09 2010-12-21 Theken Spine, Llc System and method for dynamic skeletal stabilization
US20070156241A1 (en) 2004-08-09 2007-07-05 Reiley Mark A Systems and methods for the fixation or fusion of bone
US8012209B2 (en) 2004-09-23 2011-09-06 Kyphon Sarl Interspinous process implant including a binder, binder aligner and method of implantation
US8123807B2 (en) 2004-10-20 2012-02-28 Vertiflex, Inc. Systems and methods for posterior dynamic stabilization of the spine
US8317864B2 (en) 2004-10-20 2012-11-27 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US8425559B2 (en) 2004-10-20 2013-04-23 Vertiflex, Inc. Systems and methods for posterior dynamic stabilization of the spine
US8613747B2 (en) 2004-10-20 2013-12-24 Vertiflex, Inc. Spacer insertion instrument
US8277488B2 (en) 2004-10-20 2012-10-02 Vertiflex, Inc. Interspinous spacer
US9119680B2 (en) 2004-10-20 2015-09-01 Vertiflex, Inc. Interspinous spacer
US8945183B2 (en) 2004-10-20 2015-02-03 Vertiflex, Inc. Interspinous process spacer instrument system with deployment indicator
US8409282B2 (en) 2004-10-20 2013-04-02 Vertiflex, Inc. Systems and methods for posterior dynamic stabilization of the spine
US9161783B2 (en) 2004-10-20 2015-10-20 Vertiflex, Inc. Interspinous spacer
US8012207B2 (en) * 2004-10-20 2011-09-06 Vertiflex, Inc. Systems and methods for posterior dynamic stabilization of the spine
US8123782B2 (en) 2004-10-20 2012-02-28 Vertiflex, Inc. Interspinous spacer
US9023084B2 (en) 2004-10-20 2015-05-05 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for stabilizing the motion or adjusting the position of the spine
US8152837B2 (en) 2004-10-20 2012-04-10 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US8128662B2 (en) 2004-10-20 2012-03-06 Vertiflex, Inc. Minimally invasive tooling for delivery of interspinous spacer
US8167944B2 (en) 2004-10-20 2012-05-01 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
WO2009009049A2 (en) 2004-10-20 2009-01-15 Vertiflex, Inc. Interspinous spacer
US7763074B2 (en) * 2004-10-20 2010-07-27 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US8241330B2 (en) 2007-01-11 2012-08-14 Lanx, Inc. Spinous process implants and associated methods
ATE524121T1 (en) 2004-11-24 2011-09-15 Abdou Samy DEVICES FOR PLACING AN ORTHOPEDIC INTERVERTEBRAL IMPLANT
WO2009086010A2 (en) 2004-12-06 2009-07-09 Vertiflex, Inc. Spacer insertion instrument
DE102005005694A1 (en) * 2005-02-08 2006-08-17 Henning Kloss Spine vertebra support device for twpporting two sucessive vertebras, useful in implantation processes has two supoirts and two suppor holders
US8100943B2 (en) 2005-02-17 2012-01-24 Kyphon Sarl Percutaneous spinal implants and methods
US8007521B2 (en) 2005-02-17 2011-08-30 Kyphon Sarl Percutaneous spinal implants and methods
US20080288078A1 (en) * 2005-02-17 2008-11-20 Kohm Andrew C Percutaneous spinal implants and methods
US7998174B2 (en) 2005-02-17 2011-08-16 Kyphon Sarl Percutaneous spinal implants and methods
US8157841B2 (en) 2005-02-17 2012-04-17 Kyphon Sarl Percutaneous spinal implants and methods
US8096995B2 (en) 2005-02-17 2012-01-17 Kyphon Sarl Percutaneous spinal implants and methods
US8097018B2 (en) 2005-02-17 2012-01-17 Kyphon Sarl Percutaneous spinal implants and methods
US20070276373A1 (en) * 2005-02-17 2007-11-29 Malandain Hugues F Percutaneous Spinal Implants and Methods
US8057513B2 (en) 2005-02-17 2011-11-15 Kyphon Sarl Percutaneous spinal implants and methods
US8038698B2 (en) * 2005-02-17 2011-10-18 Kphon Sarl Percutaneous spinal implants and methods
US8096994B2 (en) * 2005-02-17 2012-01-17 Kyphon Sarl Percutaneous spinal implants and methods
US20070276493A1 (en) 2005-02-17 2007-11-29 Malandain Hugues F Percutaneous spinal implants and methods
US7993342B2 (en) 2005-02-17 2011-08-09 Kyphon Sarl Percutaneous spinal implants and methods
US7927354B2 (en) 2005-02-17 2011-04-19 Kyphon Sarl Percutaneous spinal implants and methods
US20070276372A1 (en) * 2005-02-17 2007-11-29 Malandain Hugues F Percutaneous Spinal Implants and Methods
US20080039944A1 (en) * 2005-02-17 2008-02-14 Malandain Hugues F Percutaneous Spinal Implants and Methods
US7988709B2 (en) 2005-02-17 2011-08-02 Kyphon Sarl Percutaneous spinal implants and methods
US8092459B2 (en) * 2005-02-17 2012-01-10 Kyphon Sarl Percutaneous spinal implants and methods
US8034080B2 (en) * 2005-02-17 2011-10-11 Kyphon Sarl Percutaneous spinal implants and methods
US7998208B2 (en) * 2005-02-17 2011-08-16 Kyphon Sarl Percutaneous spinal implants and methods
US8029567B2 (en) 2005-02-17 2011-10-04 Kyphon Sarl Percutaneous spinal implants and methods
US20060184248A1 (en) * 2005-02-17 2006-08-17 Edidin Avram A Percutaneous spinal implants and methods
US8029549B2 (en) 2005-02-17 2011-10-04 Kyphon Sarl Percutaneous spinal implants and methods
JP2006253316A (en) * 2005-03-09 2006-09-21 Sony Corp Solid-state image sensing device
US8066742B2 (en) 2005-03-31 2011-11-29 Warsaw Orthopedic, Inc. Intervertebral prosthetic device for spinal stabilization and method of implanting same
US20060241757A1 (en) * 2005-03-31 2006-10-26 Sdgi Holdings, Inc. Intervertebral prosthetic device for spinal stabilization and method of manufacturing same
CN103479419B (en) 2005-04-08 2017-04-12 帕拉迪格脊骨有限责任公司 Interspinous vertebral and lumbosacral stabilization devices and methods of use
US7862590B2 (en) 2005-04-08 2011-01-04 Warsaw Orthopedic, Inc. Interspinous process spacer
US8034079B2 (en) 2005-04-12 2011-10-11 Warsaw Orthopedic, Inc. Implants and methods for posterior dynamic stabilization of a spinal motion segment
US7780709B2 (en) * 2005-04-12 2010-08-24 Warsaw Orthopedic, Inc. Implants and methods for inter-transverse process dynamic stabilization of a spinal motion segment
US7789898B2 (en) * 2005-04-15 2010-09-07 Warsaw Orthopedic, Inc. Transverse process/laminar spacer
US7727233B2 (en) 2005-04-29 2010-06-01 Warsaw Orthopedic, Inc. Spinous process stabilization devices and methods
US20060247634A1 (en) * 2005-05-02 2006-11-02 Warner Kenneth D Spinous Process Spacer Implant and Technique
FR2887434B1 (en) 2005-06-28 2008-03-28 Jean Taylor SURGICAL TREATMENT EQUIPMENT OF TWO VERTEBRATES
CN103169533B (en) 2005-09-27 2015-07-15 帕拉迪格脊骨有限责任公司 Interspinous vertebral stabilization devices
US8167915B2 (en) 2005-09-28 2012-05-01 Nuvasive, Inc. Methods and apparatus for treating spinal stenosis
US8357181B2 (en) 2005-10-27 2013-01-22 Warsaw Orthopedic, Inc. Intervertebral prosthetic device for spinal stabilization and method of implanting same
US7862591B2 (en) * 2005-11-10 2011-01-04 Warsaw Orthopedic, Inc. Intervertebral prosthetic device for spinal stabilization and method of implanting same
US7862592B2 (en) * 2005-12-06 2011-01-04 Nuvasive, Inc. Methods and apparatus for treating spinal stenosis
US8002802B2 (en) 2005-12-19 2011-08-23 Samy Abdou Devices and methods for inter-vertebral orthopedic device placement
US8083795B2 (en) 2006-01-18 2011-12-27 Warsaw Orthopedic, Inc. Intervertebral prosthetic device for spinal stabilization and method of manufacturing same
US20070173823A1 (en) 2006-01-18 2007-07-26 Sdgi Holdings, Inc. Intervertebral prosthetic device for spinal stabilization and method of implanting same
US7837711B2 (en) * 2006-01-27 2010-11-23 Warsaw Orthopedic, Inc. Artificial spinous process for the sacrum and methods of use
US7691130B2 (en) * 2006-01-27 2010-04-06 Warsaw Orthopedic, Inc. Spinal implants including a sensor and methods of use
US20070191838A1 (en) * 2006-01-27 2007-08-16 Sdgi Holdings, Inc. Interspinous devices and methods of use
US7682376B2 (en) 2006-01-27 2010-03-23 Warsaw Orthopedic, Inc. Interspinous devices and methods of use
US9011441B2 (en) * 2006-02-17 2015-04-21 Paradigm Spine, L.L.C. Method and system for performing interspinous space preparation for receiving an implant
US20070233068A1 (en) * 2006-02-22 2007-10-04 Sdgi Holdings, Inc. Intervertebral prosthetic assembly for spinal stabilization and method of implanting same
FR2897771B1 (en) * 2006-02-28 2008-06-06 Abbott Spine Sa INTERVERTEBRAL IMPLANT
US8262698B2 (en) 2006-03-16 2012-09-11 Warsaw Orthopedic, Inc. Expandable device for insertion between anatomical structures and a procedure utilizing same
US8025681B2 (en) 2006-03-29 2011-09-27 Theken Spine, Llc Dynamic motion spinal stabilization system
US7985246B2 (en) * 2006-03-31 2011-07-26 Warsaw Orthopedic, Inc. Methods and instruments for delivering interspinous process spacers
FR2899788B1 (en) * 2006-04-13 2008-07-04 Jean Taylor TREATMENT EQUIPMENT FOR VERTEBRATES, COMPRISING AN INTEREPINOUS IMPLANT
US8118844B2 (en) 2006-04-24 2012-02-21 Warsaw Orthopedic, Inc. Expandable device for insertion between anatomical structures and a procedure utilizing same
US7846185B2 (en) * 2006-04-28 2010-12-07 Warsaw Orthopedic, Inc. Expandable interspinous process implant and method of installing same
US8105357B2 (en) 2006-04-28 2012-01-31 Warsaw Orthopedic, Inc. Interspinous process brace
US8348978B2 (en) * 2006-04-28 2013-01-08 Warsaw Orthopedic, Inc. Interosteotic implant
US8252031B2 (en) 2006-04-28 2012-08-28 Warsaw Orthopedic, Inc. Molding device for an expandable interspinous process implant
DE102007018860B4 (en) * 2006-04-28 2023-01-05 Paradigm Spine L.L.C. Instrument system for use with an interspinous implant
US20070270823A1 (en) 2006-04-28 2007-11-22 Sdgi Holdings, Inc. Multi-chamber expandable interspinous process brace
US8048118B2 (en) 2006-04-28 2011-11-01 Warsaw Orthopedic, Inc. Adjustable interspinous process brace
US8062337B2 (en) 2006-05-04 2011-11-22 Warsaw Orthopedic, Inc. Expandable device for insertion between anatomical structures and a procedure utilizing same
US8147517B2 (en) 2006-05-23 2012-04-03 Warsaw Orthopedic, Inc. Systems and methods for adjusting properties of a spinal implant
US20070276496A1 (en) * 2006-05-23 2007-11-29 Sdgi Holdings, Inc. Surgical spacer with shape control
US8303601B2 (en) 2006-06-07 2012-11-06 Stryker Spine Collet-activated distraction wedge inserter
US8048119B2 (en) 2006-07-20 2011-11-01 Warsaw Orthopedic, Inc. Apparatus for insertion between anatomical structures and a procedure utilizing same
US8834526B2 (en) 2006-08-09 2014-09-16 Rolando Garcia Methods and apparatus for treating spinal stenosis
FR2907329B1 (en) * 2006-10-20 2009-02-27 Jean Taylor INTEREPINEAL VERTEBRAL PROSTHESIS
US20080086115A1 (en) * 2006-09-07 2008-04-10 Warsaw Orthopedic, Inc. Intercostal spacer device and method for use in correcting a spinal deformity
US20080071380A1 (en) * 2006-09-19 2008-03-20 Thomas Sweeney Systems and Methods for Percutaneous Placement of Interspinous Process Spacers
US8092533B2 (en) * 2006-10-03 2012-01-10 Warsaw Orthopedic, Inc. Dynamic devices and methods for stabilizing vertebral members
US20080161920A1 (en) * 2006-10-03 2008-07-03 Warsaw Orthopedic, Inc. Dynamizing Interbody Implant and Methods for Stabilizing Vertebral Members
US8845726B2 (en) 2006-10-18 2014-09-30 Vertiflex, Inc. Dilator
US8097019B2 (en) 2006-10-24 2012-01-17 Kyphon Sarl Systems and methods for in situ assembly of an interspinous process distraction implant
US20080177298A1 (en) * 2006-10-24 2008-07-24 St. Francis Medical Technologies, Inc. Tensioner Tool and Method for Implanting an Interspinous Process Implant Including a Binder
FR2908035B1 (en) 2006-11-08 2009-05-01 Jean Taylor INTEREPINE IMPLANT
US20080114357A1 (en) * 2006-11-15 2008-05-15 Warsaw Orthopedic, Inc. Inter-transverse process spacer device and method for use in correcting a spinal deformity
US7879104B2 (en) 2006-11-15 2011-02-01 Warsaw Orthopedic, Inc. Spinal implant system
AR064013A1 (en) * 2006-11-30 2009-03-04 Paradigm Spine Llc VERTEBRAL, INTERLAMINAR, INTERESPINOUS STABILIZATION SYSTEM
US8105382B2 (en) 2006-12-07 2012-01-31 Interventional Spine, Inc. Intervertebral implant
US7955392B2 (en) 2006-12-14 2011-06-07 Warsaw Orthopedic, Inc. Interspinous process devices and methods
US8974496B2 (en) 2007-08-30 2015-03-10 Jeffrey Chun Wang Interspinous implant, tools and methods of implanting
US9265532B2 (en) 2007-01-11 2016-02-23 Lanx, Inc. Interspinous implants and methods
CN101677862B (en) 2007-02-06 2012-04-18 先锋外科技术公司 Intervertebral implant devices and methods for insertion thereof
US7842074B2 (en) * 2007-02-26 2010-11-30 Abdou M Samy Spinal stabilization systems and methods of use
US9545267B2 (en) * 2007-03-26 2017-01-17 Globus Medical, Inc. Lateral spinous process spacer
WO2008124831A2 (en) * 2007-04-10 2008-10-16 Lee David M D Adjustable spine distraction implant
EP2155121B1 (en) 2007-04-16 2015-06-17 Vertiflex, Inc. Interspinous spacer
US8142479B2 (en) * 2007-05-01 2012-03-27 Spinal Simplicity Llc Interspinous process implants having deployable engagement arms
US20080281361A1 (en) * 2007-05-10 2008-11-13 Shannon Marlece Vittur Posterior stabilization and spinous process systems and methods
US8840646B2 (en) 2007-05-10 2014-09-23 Warsaw Orthopedic, Inc. Spinous process implants and methods
US20080294199A1 (en) * 2007-05-25 2008-11-27 Andrew Kohm Spinous process implants and methods of using the same
US8070779B2 (en) * 2007-06-04 2011-12-06 K2M, Inc. Percutaneous interspinous process device and method
US8900307B2 (en) 2007-06-26 2014-12-02 DePuy Synthes Products, LLC Highly lordosed fusion cage
US8348976B2 (en) * 2007-08-27 2013-01-08 Kyphon Sarl Spinous-process implants and methods of using the same
US20090105773A1 (en) * 2007-10-23 2009-04-23 Warsaw Orthopedic, Inc. Method and apparatus for insertion of an interspinous process device
WO2009091922A2 (en) 2008-01-15 2009-07-23 Vertiflex, Inc. Interspinous spacer
EP2471493A1 (en) 2008-01-17 2012-07-04 Synthes GmbH An expandable intervertebral implant and associated method of manufacturing the same
US20090198338A1 (en) 2008-02-04 2009-08-06 Phan Christopher U Medical implants and methods
US8114136B2 (en) 2008-03-18 2012-02-14 Warsaw Orthopedic, Inc. Implants and methods for inter-spinous process dynamic stabilization of a spinal motion segment
US8202299B2 (en) 2008-03-19 2012-06-19 Collabcom II, LLC Interspinous implant, tools and methods of implanting
US8343190B1 (en) 2008-03-26 2013-01-01 Nuvasive, Inc. Systems and methods for spinous process fixation
CA2720580A1 (en) 2008-04-05 2009-10-08 Synthes Usa, Llc Expandable intervertebral implant
US9301788B2 (en) 2008-04-10 2016-04-05 Life Spine, Inc. Adjustable spine distraction implant
US20100030549A1 (en) * 2008-07-31 2010-02-04 Lee Michael M Mobile device having human language translation capability with positional feedback
US8172878B2 (en) 2008-08-27 2012-05-08 Yue James J Conical interspinous apparatus and a method of performing interspinous distraction
US8292923B1 (en) 2008-10-13 2012-10-23 Nuvasive, Inc. Systems and methods for treating spinal stenosis
US8114131B2 (en) 2008-11-05 2012-02-14 Kyphon Sarl Extension limiting devices and methods of use for the spine
US8114135B2 (en) * 2009-01-16 2012-02-14 Kyphon Sarl Adjustable surgical cables and methods for treating spinal stenosis
US20100217272A1 (en) * 2009-02-20 2010-08-26 Holt Development Llc Method and apparatus for positioning implant between spinous processes
US9757164B2 (en) 2013-01-07 2017-09-12 Spinal Simplicity Llc Interspinous process implant having deployable anchor blades
US9861399B2 (en) 2009-03-13 2018-01-09 Spinal Simplicity, Llc Interspinous process implant having a body with a removable end portion
US9526620B2 (en) 2009-03-30 2016-12-27 DePuy Synthes Products, Inc. Zero profile spinal fusion cage
WO2010114925A1 (en) 2009-03-31 2010-10-07 Lanx, Inc. Spinous process implants and associated methods
US9050194B2 (en) 2009-05-06 2015-06-09 Stryker Spine Expandable spinal implant apparatus and method of use
US8372117B2 (en) 2009-06-05 2013-02-12 Kyphon Sarl Multi-level interspinous implants and methods of use
US8157842B2 (en) 2009-06-12 2012-04-17 Kyphon Sarl Interspinous implant and methods of use
TW201103521A (en) * 2009-07-20 2011-02-01 Wei-Zhen Hong Spinal fusion device
US8771317B2 (en) 2009-10-28 2014-07-08 Warsaw Orthopedic, Inc. Interspinous process implant and method of implantation
US8795335B1 (en) 2009-11-06 2014-08-05 Samy Abdou Spinal fixation devices and methods of use
US8764806B2 (en) 2009-12-07 2014-07-01 Samy Abdou Devices and methods for minimally invasive spinal stabilization and instrumentation
US9393129B2 (en) 2009-12-10 2016-07-19 DePuy Synthes Products, Inc. Bellows-like expandable interbody fusion cage
US8740948B2 (en) 2009-12-15 2014-06-03 Vertiflex, Inc. Spinal spacer for cervical and other vertebra, and associated systems and methods
US8317831B2 (en) 2010-01-13 2012-11-27 Kyphon Sarl Interspinous process spacer diagnostic balloon catheter and methods of use
US8114132B2 (en) 2010-01-13 2012-02-14 Kyphon Sarl Dynamic interspinous process device
US8147526B2 (en) 2010-02-26 2012-04-03 Kyphon Sarl Interspinous process spacer diagnostic parallel balloon catheter and methods of use
JP5272279B2 (en) * 2010-03-09 2013-08-28 国立大学法人神戸大学 Interspinous process implant
US9592063B2 (en) 2010-06-24 2017-03-14 DePuy Synthes Products, Inc. Universal trial for lateral cages
US8979860B2 (en) 2010-06-24 2015-03-17 DePuy Synthes Products. LLC Enhanced cage insertion device
TW201215379A (en) 2010-06-29 2012-04-16 Synthes Gmbh Distractible intervertebral implant
US8814908B2 (en) 2010-07-26 2014-08-26 Warsaw Orthopedic, Inc. Injectable flexible interspinous process device system
WO2012040001A1 (en) 2010-09-20 2012-03-29 Pachyderm Medical, L.L.C. Integrated ipd devices, methods, and systems
US9402732B2 (en) 2010-10-11 2016-08-02 DePuy Synthes Products, Inc. Expandable interspinous process spacer implant
US8496689B2 (en) 2011-02-23 2013-07-30 Farzad Massoudi Spinal implant device with fusion cage and fixation plates and method of implanting
US8562650B2 (en) 2011-03-01 2013-10-22 Warsaw Orthopedic, Inc. Percutaneous spinous process fusion plate assembly and method
US8425560B2 (en) 2011-03-09 2013-04-23 Farzad Massoudi Spinal implant device with fixation plates and lag screws and method of implanting
US8591548B2 (en) 2011-03-31 2013-11-26 Warsaw Orthopedic, Inc. Spinous process fusion plate assembly
US8591549B2 (en) 2011-04-08 2013-11-26 Warsaw Orthopedic, Inc. Variable durometer lumbar-sacral implant
USD757943S1 (en) 2011-07-14 2016-05-31 Nuvasive, Inc. Spinous process plate
US8882805B1 (en) 2011-08-02 2014-11-11 Lawrence Maccree Spinal fixation system
US8845728B1 (en) 2011-09-23 2014-09-30 Samy Abdou Spinal fixation devices and methods of use
US11812923B2 (en) 2011-10-07 2023-11-14 Alan Villavicencio Spinal fixation device
US20130226240A1 (en) 2012-02-22 2013-08-29 Samy Abdou Spinous process fixation devices and methods of use
IN2014DN06946A (en) 2012-03-09 2015-04-10 Si Bone Inc
WO2013134682A1 (en) 2012-03-09 2013-09-12 Si-Bone Inc. Artificial si joint
US10363140B2 (en) 2012-03-09 2019-07-30 Si-Bone Inc. Systems, device, and methods for joint fusion
US10448977B1 (en) 2012-03-31 2019-10-22 Ali H. MESIWALA Interspinous device and related methods
ES2828357T3 (en) 2012-05-04 2021-05-26 Si Bone Inc Fenestrated implant
US8940052B2 (en) 2012-07-26 2015-01-27 DePuy Synthes Products, LLC Expandable implant
US9198767B2 (en) 2012-08-28 2015-12-01 Samy Abdou Devices and methods for spinal stabilization and instrumentation
US20140067069A1 (en) 2012-08-30 2014-03-06 Interventional Spine, Inc. Artificial disc
US9320617B2 (en) 2012-10-22 2016-04-26 Cogent Spine, LLC Devices and methods for spinal stabilization and instrumentation
US9522070B2 (en) 2013-03-07 2016-12-20 Interventional Spine, Inc. Intervertebral implant
US9675303B2 (en) 2013-03-15 2017-06-13 Vertiflex, Inc. Visualization systems, instruments and methods of using the same in spinal decompression procedures
US9936983B2 (en) 2013-03-15 2018-04-10 Si-Bone Inc. Implants for spinal fixation or fusion
WO2015001661A1 (en) * 2013-07-05 2015-01-08 テルモ株式会社 Medical assistance tool, medical tool, and method of measuring distance
US11147688B2 (en) 2013-10-15 2021-10-19 Si-Bone Inc. Implant placement
WO2015057866A1 (en) 2013-10-15 2015-04-23 Si-Bone Inc. Implant placement
AU2015256024B2 (en) 2014-05-07 2020-03-05 Vertiflex, Inc. Spinal nerve decompression systems, dilation systems, and methods of using the same
US9662157B2 (en) 2014-09-18 2017-05-30 Si-Bone Inc. Matrix implant
WO2016044731A1 (en) 2014-09-18 2016-03-24 Si-Bone Inc. Implants for bone fixation or fusion
US11426290B2 (en) 2015-03-06 2022-08-30 DePuy Synthes Products, Inc. Expandable intervertebral implant, system, kit and method
US10376206B2 (en) 2015-04-01 2019-08-13 Si-Bone Inc. Neuromonitoring systems and methods for bone fixation or fusion procedures
US9913727B2 (en) 2015-07-02 2018-03-13 Medos International Sarl Expandable implant
US10857003B1 (en) 2015-10-14 2020-12-08 Samy Abdou Devices and methods for vertebral stabilization
JP7023877B2 (en) 2016-06-28 2022-02-22 イーアイティー・エマージング・インプラント・テクノロジーズ・ゲーエムベーハー Expandable and angle-adjustable range-of-motion intervertebral cage
CN109688981A (en) 2016-06-28 2019-04-26 Eit 新兴移植技术股份有限公司 Distensible, adjustable angle intervertebral cage
US10744000B1 (en) 2016-10-25 2020-08-18 Samy Abdou Devices and methods for vertebral bone realignment
US10973648B1 (en) 2016-10-25 2021-04-13 Samy Abdou Devices and methods for vertebral bone realignment
US10537436B2 (en) 2016-11-01 2020-01-21 DePuy Synthes Products, Inc. Curved expandable cage
US10888433B2 (en) 2016-12-14 2021-01-12 DePuy Synthes Products, Inc. Intervertebral implant inserter and related methods
US10398563B2 (en) 2017-05-08 2019-09-03 Medos International Sarl Expandable cage
US11344424B2 (en) 2017-06-14 2022-05-31 Medos International Sarl Expandable intervertebral implant and related methods
US10940016B2 (en) 2017-07-05 2021-03-09 Medos International Sarl Expandable intervertebral fusion cage
AU2018327353A1 (en) 2017-09-08 2020-03-19 Pioneer Surgical Technology, Inc. Intervertebral implants, instruments, and methods
EP3687422A4 (en) 2017-09-26 2021-09-22 SI-Bone, Inc. Systems and methods for decorticating the sacroiliac joint
USD907771S1 (en) 2017-10-09 2021-01-12 Pioneer Surgical Technology, Inc. Intervertebral implant
US11179248B2 (en) 2018-10-02 2021-11-23 Samy Abdou Devices and methods for spinal implantation
US11446156B2 (en) 2018-10-25 2022-09-20 Medos International Sarl Expandable intervertebral implant, inserter instrument, and related methods
US11369419B2 (en) 2019-02-14 2022-06-28 Si-Bone Inc. Implants for spinal fixation and or fusion
AU2020223180A1 (en) 2019-02-14 2021-07-22 Si-Bone Inc. Implants for spinal fixation and or fusion
EP4065015A4 (en) 2019-11-27 2024-01-03 Si Bone Inc Bone stabilizing implants and methods of placement across si joints
US11426286B2 (en) 2020-03-06 2022-08-30 Eit Emerging Implant Technologies Gmbh Expandable intervertebral implant
EP4259015A1 (en) 2020-12-09 2023-10-18 SI-Bone, Inc. Sacro-iliac joint stabilizing implants and methods of implantation
US11850160B2 (en) 2021-03-26 2023-12-26 Medos International Sarl Expandable lordotic intervertebral fusion cage
US11752009B2 (en) 2021-04-06 2023-09-12 Medos International Sarl Expandable intervertebral fusion cage

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5645599A (en) * 1994-07-26 1997-07-08 Fixano Interspinal vertebral implant
US20040024458A1 (en) * 2000-12-22 2004-02-05 Jacques Senegas Intervertebral implant with deformable wedge
US20040181282A1 (en) * 2002-10-29 2004-09-16 Zucherman James F. Interspinous process apparatus and method with a selectably expandable spacer
US20050228384A1 (en) * 1997-01-02 2005-10-13 St. Francis Medical Technologies, Inc. Spinous process implant with tethers

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5645599A (en) * 1994-07-26 1997-07-08 Fixano Interspinal vertebral implant
US20050228384A1 (en) * 1997-01-02 2005-10-13 St. Francis Medical Technologies, Inc. Spinous process implant with tethers
US20040024458A1 (en) * 2000-12-22 2004-02-05 Jacques Senegas Intervertebral implant with deformable wedge
US20040181282A1 (en) * 2002-10-29 2004-09-16 Zucherman James F. Interspinous process apparatus and method with a selectably expandable spacer

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1807012A2 (en) * 2004-10-25 2007-07-18 Robert E. Lins Interspinous distraction devices and associated methods of insertion
EP1807012A4 (en) * 2004-10-25 2010-12-29 Lanx Llc Interspinous distraction devices and associated methods of insertion
EP1850799A2 (en) * 2005-02-04 2007-11-07 Nuvasive, Inc. Methods and apparatus for treating spinal stenosis
EP1850799A4 (en) * 2005-02-04 2014-07-30 Nuvasive Inc Methods and apparatus for treating spinal stenosis
WO2007018114A1 (en) 2005-08-11 2007-02-15 National University Corporation Kobe University Minimally-invasive implant for opening and enlargement of processus spinosus interspace and method of percutaneously enlarging processus spinosus interspace therewith
GB2436293A (en) * 2006-03-24 2007-09-26 Galley Geoffrey H Spinous processes insertion device
JP2011502573A (en) * 2007-11-02 2011-01-27 ランクス インコーポレイテッド Spine implant and method

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