WO2006017397A2 - Methods and apparatus for intervertebral disc prosthesis insertion - Google Patents
Methods and apparatus for intervertebral disc prosthesis insertion Download PDFInfo
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- WO2006017397A2 WO2006017397A2 PCT/US2005/027049 US2005027049W WO2006017397A2 WO 2006017397 A2 WO2006017397 A2 WO 2006017397A2 US 2005027049 W US2005027049 W US 2005027049W WO 2006017397 A2 WO2006017397 A2 WO 2006017397A2
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- prosthesis
- space
- vertebrae
- endplates
- pushing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
- A61F2/4611—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses
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- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical 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
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Definitions
- intervertebral disc prostheses As the use of intervertebral disc prostheses increases, an increasing need exists for improved methods and apparatus for inserting such prostheses.
- such intervertebral prosthesis insertion methods and devices would provide for insertion of a prosthesis a desired distance into an intervertebral space while reducing the need for intervertebral distraction, thus preventing or at least reducing trauma to surrounding tissues.
- such insertion methods and devices would be relatively simple and easy to use, thereby reducing the overall invasiveness of the procedure. At least some of these objectives will be met by the present invention.
- the present invention generally provides methods for inserting an intervertebral disc prosthesis, as well as devices and systems for performing the methods.
- One advantage of these improved methods is that a disc prosthesis may be inserted with minimal or reduced intervertebral distraction, thus avoiding trauma to tissues in and around the insertion site.
- Reduced distraction is generally achieved by inserting a prosthesis into an intervertebral space while allowing endplates of the prosthesis to articulate during at least part of the insertion process.
- to "articulate" means to move relative to another structure.
- endplates of an intervertebral prosthesis to articulate means that endplates are free to move relative to each other, relative to a core of the prosthesis, relative to a ball and socket joint of the prosthesis, relative to a mobile or fixed center of rotation of the prosthesis and/or the like.
- various embodiments of the insertion method may be applied to any other intervertebral disc prosthesis. Articulation of the endplates during insertion allows the prosthesis to be pushed posteriorly into a disc space without excessive intervertebral distraction or significant forces being applied to the vertebrae, thus achieving desirable positioning of the prosthesis while avoiding trauma to surrounding muscles, ligaments, nerves and the like.
- Some embodiments also involve using a vertebral midpoint indicator device to locate a midpoint of at least one of the two vertebrae, and marking the midpoint on one or both of the two vertebrae.
- a midline indicator device is described by the assignees of the present application in PCT Patent Application Number 2004/000170, filed January 26, 2004 (Attorney Docket Number currently being updated with International Bureau to 022031-000900PC), the full disclosure of which is hereby incorporated by reference.
- Midline finding and marking are typically performed before inserting the constrained prosthesis partway into the intervertebral space.
- locating the midpoint involves inserting the vertebral midpoint indicator device into the space between the vertebrae and imaging the midpoint indicator device using a radiographic imaging device.
- the grasping member comprises movable opposing jaws adapted to simultaneously grasp inner rims of the endplates.
- a grasping member may, for example, be coupled with the actuator via at least one rod extending through the shaft.
- the grasping member may include a first half coupled with a first movable rod extending from the actuator and a second half coupled with a second movable rod extending from the actuator, hi some embodiments, the actuator comprises a thumb screw adapted to move the first and second rods closer together and farther apart by turning the thumb screw in opposite directions.
- a system for inserting an intervertebral prosthesis into a space between two adjacent vertebrae includes a prosthesis grasping device for grasping the prosthesis and pushing the prosthesis at least partway into the space and at least one prosthesis pusher device for pushing the prosthesis farther into the space.
- the grasping device is similar to the device described immediately above and may include any of the described features.
- the pusher device may include: an elongate shaft having a proximal end and a distal end; a concave pusher portion disposed at the distal end, the pusher portion adapted to push the endplates either simultaneously or individually into the space; and a handle disposed at the proximal end.
- the system further includes a vertebral spacing device for increasing a height of the space between the two vertebrae.
- a vertebral spacing device for increasing a height of the space between the two vertebrae.
- the grasping member is adapted to slide through the vertebral spacing device disposed between two adjacent vertebrae.
- the pusher device may also be adapted to slide through the spacing device.
- FIGs. 2 A and 2B are top views of a grasping device for inserting an intervertebral disc prosthesis according to one embodiment of the present invention.
- FIG. 3 is a top view of a pusher device for inserting an intervertebral disc prosthesis according to one embodiment of the present invention.
- Fig. 5 demonstrates the spreading action of the spreader device in Figs. 4A-4E.
- FIGs. 6A-6D are various views of a vertebral body midline indicator device according to one embodiment of the present invention.
- the insertion device 102 may be used to push the unconstrained prosthesis 104 farther into the intervertebral space.
- one or more separate pusher devices may be used in addition to or instead of the insertion device 102 for pushing the prosthesis 104 farther into the space IS.
- Figs. 1C and ID demonstrate that in one embodiment the grasping member 110 of the insertion device 102 is adapted to push individually against the upper (Fig. 1C) and lower (Fig. ID) endplates 106.
- the grasping member 110 may also be adapted to push simultaneously against the upper and lower endplates 106, thus pushing the prosthesis 104 as a unit farther into the intervertebral space IS.
- midline indicator device An example of such a midline indicator device is described in PCT Patent Application Number 2004/000170, previously incorporated by reference. Typically, the midline indicator is used before the disc prosthesis 104 is inserted. These and other steps or features may be included in various embodiments of the method without departing from the scope of the invention.
- the insertion device 120 may grasp a disc prosthesis 140 such that the grasping member 122 does not protrude beyond an outer edge 141 of the prosthesis 140.
- the grasping member 122 holds onto an inner portion of the prosthesis 140, so that it will not extend beyond the lateral edges 141 of the prosthesis 140.
- This configuration is advantageous during insertion, as the grasping member 122 is essentially out of the way, within the outer edge 141 of the prosthesis 140.
- Fig. 2C is a side view of a distal end of the insertion device 120 shown in Figs. 2 A and 2B. It is more readily seen that the disc prosthesis 140 includes a core 146 and two endplates 142.
- Each endplate 142 includes an inner rim 144 that contacts the core 146 and a fin 148 for enhancing attachment to vertebral bone.
- the grasping member 122 of the insertion device 120 grasps the inner rims 144 of the endplates 142, thus positioning it within the outer edges 141 of the endplates 142.
- any suitable alternative prosthesis may be used, as well as any suitable insertion device (or devices).
- a separate pusher device 150 may be used to push an unconstrained prosthesis 140 farther into an intervertebral space.
- the pusher device 150 is typically constructed of stainless steel or other suitable metal and suitably includes an elongate shaft 152, a pusher member 154 at the distal end of the shaft 152, and a handle 158 at the proximal end of the shaft 152.
- the pusher member 154 includes a concave inner portion 156 for pushing against the inner rims 144 of endplates 142 of the prosthesis 140.
- the concave portion 156 may be tapered and/or rounded to facilitate pushing against upper and lower endplates 142 individually while also allowing for simultaneous pushing against both endplates 142.
- the pusher device 150 may have any of a number of alternative configurations, shapes, sizes and the like. In some embodiments, multiple pusher devices 150 of different configurations and/or sizes are provided to allow a physician to select one or more desired devices 150.
- a spreader device 10 for spreading adjacent vertebrae to facilitate intervertebral disc prosthesis 30 insertion is shown. Again, the device 10 is described in greater detail in PCT Patent Application Number 2004/000171, which was previously incorporated by reference.
- the spreader device 10 generally includes distally located opposable jaws 12, a slidable pusher member 45 and an actuator 15.
- the opposable jaws 12 are carried by arms 14 which form part of a scissors-type mechanism having a single hinge point 15.
- Handles 16 on the proximal end of the device are used to manipulate the opposable jaws 12. When the handles 16 are actuated, arms 14 translate the actuation motion to the single hinge point scissors type mechanism 15.
- Figs. 4A and 4B illustrate how the handles 14 are inclined relative to the jaws 12. Manipulation of the handles 16 by moving them causes the jaws 12 to open or close. Other embodiments include a double hinge instead of the single hinge 15 which would pivot the jaws apart from one another when the handles 16 are displaced towards one another.
- the insertion device 10 illustrated in Figs. 4A-4E is designed for placement of an intervertebral prosthetic disc 30.
- a prosthetic disc 30 comprises opposing endplates 32 which are located on opposite sides of a central core 34.
- the opposing endplates 32 articulate about the central core 34.
- the prosthetic disc 30 also comprises projecting fins 36 which are aligned with matching slots 40 in the vertebrae 38 during implantation. Typically slots 40 are saw cut into the vertebrae 38.
- FIGs. 4D and 5 A method of inserting the intervertebral prosthesis is illustrated in Figs. 4D and 5.
- the vertebrae 38 are distracted by a distance sufficient for at least partial insertion of the prosthesis 30.
- the tips 24 of the opposable jaws 12 are inserted between the vertebrae 38 with the slots 22 in the opposable jaws 12 aligned with the slots in the vertebrae 40.
- the handles 16 are then manipulated to force the opposable jaws 12 apart which also forces the vertebrae 38 apart from one another, creating a gap.
- the prosthesis 30 is then inserted into the gap 42 between the opposable jaws 12 where it is held therein with fins 36 engaged with the corresponding slots 22.
- the prosthesis placement procedure may be modified so that the initial distraction of the vertebra 38 is achieved by manipulation of the handles 16 and then a force may be applied manually to the pusher 45 or it may be tapped in order to create the final intervertebral gap and placement of the prosthesis 30.
- the spreader device 10 serves both to facilitate insertion of the prosthesis 30 between the vertebrae 38 and also to ensure that the prosthesis 30 is accurately guided into position with its fins 36 lined up with the vertebral slots 40.
- Fig. 5 shows in greater detail (solid-tipped arrows) the various motions involved in inserting the spreader device 10 into the intervertebral space and manipulating the handles 16 to force open the jaws 12 and thus increased the height of the intervertebral space between the two adjacent vertebrae 38.
- this or other spreader devices 10 is optional and is not required in all embodiments.
- Embedded in the body 214 are two elongate radiopaque markers 216, also made of any suitable radiopaque material(s).
- the markers 216 are parallel to the shaft 212 and are located on opposite sides and equidistant from the shaft 212.
- FIGs. 7A and 7B demonstrate a method for using the midline indicator to find a vertebral body midline 222.
- Fig. 7A shows, in anterior view, adjacent upper 218 and lower 220 vertebrae.
- the surgeon uses the shaft 212 to insert the body 214 between the vertebrae 218, 220.
- the surgeon attempts to position the shaft 212 at the vertebral midline 222, and a radiograph is taken of the vertebrae 218, 220 and indicator 210 from the anterior-posterior (A-P) direction.
- A-P anterior-posterior
- the shaft 212 and markers 216 are properly aligned in the A-P direction, they will appear as dots on the radiograph. If the midline indicator 210 is turned, however, as is demonstrated by the dotted lines in Fig. 7B, the shaft 212 and markers 216 will show up as lines or stretched-out dots on the radiograph.
- the A-P direction of the radiograph is shown by 224, with misalignment of the indicator 210 shown by angles ⁇ .
- the surgeon positions the handle 212 of the indicator 210 at the vertebral midline 222. The surgeon may then make a mark 226 in one or more vertebrae 218, 220 to indicate the midline 222.
- the mark 226 may be made by any suitable means, such as by burning with an electrocautery device, marking with a marking pen, inserting a pin, or the like. After one or more midline marks 226 are made, the midline indicator 210 is removed and the disc prosthesis (not shown) is inserted. Again, the midline finding step is optional.
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
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JP2007524870A JP4580986B2 (en) | 2004-08-06 | 2005-07-29 | Method and apparatus for inserting an intervertebral disc prosthesis |
EP17172943.7A EP3241529B1 (en) | 2004-08-06 | 2005-07-29 | Instrument set for inserting an articulating intervertebral disc prosthesis |
EP05777414.3A EP1778135B1 (en) | 2004-08-06 | 2005-07-29 | Apparatus for intervertebral disc prosthesis insertion |
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US10/913,780 US7585326B2 (en) | 2004-08-06 | 2004-08-06 | Methods and apparatus for intervertebral disc prosthesis insertion |
US10/913,780 | 2004-08-06 |
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WO2006017397A2 true WO2006017397A2 (en) | 2006-02-16 |
WO2006017397A3 WO2006017397A3 (en) | 2007-06-07 |
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PCT/US2005/027049 WO2006017397A2 (en) | 2004-08-06 | 2005-07-29 | Methods and apparatus for intervertebral disc prosthesis insertion |
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EP (2) | EP3241529B1 (en) |
JP (2) | JP4580986B2 (en) |
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WO (1) | WO2006017397A2 (en) |
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