WO2011108950A1 - Prosthesis for spinal column, instrument for its guiding and method for implantation thereof - Google Patents
Prosthesis for spinal column, instrument for its guiding and method for implantation thereof Download PDFInfo
- Publication number
- WO2011108950A1 WO2011108950A1 PCT/PL2011/000013 PL2011000013W WO2011108950A1 WO 2011108950 A1 WO2011108950 A1 WO 2011108950A1 PL 2011000013 W PL2011000013 W PL 2011000013W WO 2011108950 A1 WO2011108950 A1 WO 2011108950A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- prosthesis
- positioner
- instrument
- hole
- situated
- Prior art date
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Classifications
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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
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
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- A—HUMAN NECESSITIES
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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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
- A61F2/4465—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
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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
- A61F2/02—Prostheses implantable into the body
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- 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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- 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
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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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- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2002/30383—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
- A61F2002/3039—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove with possibility of relative movement of the rib within the groove
- A61F2002/30392—Rotation
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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
- A61F2/02—Prostheses implantable into the body
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- A61F2002/30383—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
- A61F2002/3039—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove with possibility of relative movement of the rib within the groove
- A61F2002/30398—Sliding
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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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30772—Apertures or holes, e.g. of circular cross section
- A61F2002/30784—Plurality of holes
- A61F2002/30787—Plurality of holes inclined obliquely with respect to each other
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- 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
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- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
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- 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
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
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- A61F2002/30843—Pyramidally-shaped
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- 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
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30904—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves serrated profile, i.e. saw-toothed
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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
- A61F2/02—Prostheses implantable into the body
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- 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
- A61F2002/4625—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 with relative movement between parts of the instrument during use
- A61F2002/4628—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 with relative movement between parts of the instrument during use with linear motion along or rotating motion about an axis transverse to the instrument axis or to the implantation direction, e.g. clamping
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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
- 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
- A61F2002/4629—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 connected to the endoprosthesis or implant via a threaded connection
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- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
-
- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0041—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using additional screws, bolts, dowels or rivets, e.g. connecting screws
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- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
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- A—HUMAN NECESSITIES
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- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0069—Three-dimensional shapes cylindrical
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0093—Umbrella-shaped, e.g. mushroom-shaped
Definitions
- the invention relates to a prosthesis of an anterior spinal column, prosthesis-guiding instrument and method for installation thereof, which find application in the treatment of cervical, thoracic and lumbar spinal segments.
- a spinal prosthesis in the form of a cylinder with a perforated wall and prostheses of intervertebral discs attached to it made of spring silicone rubber in the shape of balloons.
- Anchoring of the cylinder in the damaged vertebra is provided by means of an entrapment of an elongate lug of the cylinder within a slot of a plate retained by screws within a recess of the damaged vertebra.
- the springs of the resilient beads are attached to the natural vertebrae, superior and inferior to the damaged vertebra by fixing plates provided with flanges that are fixed by screws to those vertebrae.
- a prosthesis for a partial replacement of a vertebral body which has an upper contact plate for connection to an upper vertebral body, a lower contact plate for connection to a lower vertebral body, and a bridging part which connects the upper and lower contact plates to each other and bridges at least one vertebral body which is located between the upper and lower vertebral bodies.
- the bridging part is accommodated in a recess in the vertebral body.
- the prosthesis has lateral anchoring projections, which penetrate into the bone substance, located on both sides of the bridging part. Its cross section narrows toward the rear preferably in a trapezoid shape.
- the inconvenience of this solution is the complex structure of the prosthesis and necessity of accommodating the bony recess to the bridging part to reinforce the support of the vertebral body.
- a prosthesis for the replacement of all vertebral elements such as the vertebral body, the pedicles v/ith the joint facets and the lamina is known from the patent application EP1188424.
- the prosthesis has interconnection capability to a posterior fusion system by means of special screws.
- the prosthesis consists of the front part, which in a section is in the octagonal shape and screws that can connect it to the posterior fixation pedicle screw system and thus create a complete construction which replaces the whole dislocated vertebral unit.
- the inconvenience of this solution is the necessity of cooperation with an additional posterior spinal stabilization by a posterior fusion system and the complicated two-stage surgical operation - first, using the posterior, and then the anterio-lateral approach.
- a prosthesis which has a telescopic perforated cylinder is known from the patent application EP 0968692
- the cylinder consists of two parts and an intersected shield, connected by screws.
- the telescopic construction allows regulating the length of the prosthesis depending on the distance between the neighboring vertebrae.
- the prosthesis is situated in a definite position by two external screws fixed in the cylinder's hole.
- the cylinder is provided with teeth and other anchoring elements preventing sliding of the prosthesis and a decrease of its height during implantation.
- the inconvenience of this solution is the multi-element construction of the prosthesis. Bearing surfaces of the prosthesis are small, which decreases its load bearing capacity.
- the round shape of cylinders is not accommodated to the anatomy of the spine. For a proper placement of the prosthesis it is necessary to use an external element in the form of the above mentioned screws.
- a monorail system which improves the use of the procedure of a spinal fusion, and a method for preparation of the intervertebral space and for introduction of the implant are known from the patent application US 2007/0270873.
- the system consists of an instrument for distraction of the intervertebral space, preferably in the form of a rod having a rail, chisel provided with a canal cooperating with the rail and an implant provided with a canal cooperating with the rail.
- the instrument for distraction whose sliding section is constituted by the rail, cooperates with other instruments used for preparation of the intervertebral space and may act as an instrument for inserting the implant into the intervertebral space.
- the instrument and the implant are provided with a canal which is connected with the rail during guiding and controlling their insertion into the disc space.
- the inconvenience of this solution is a lack of the possibility of positioning and anchoring the instrument during insertion of the implant into the intervertebral space.
- the instrument may slide and harm sensitive tissues.
- a method of installation of an expandable prosthesis for support of the anterior spinal column is known from the instruction of use of the LfC implant.
- the method consists in: resection of vertebral body/bodies to enable secure, axial installation of the prosthesis,
- a method of performance of vertebral body replacement surgery is known from the instruction of introducing the ECD implant - Expandable Corpectomy Device of Synthes .
- the method consists in:
- spinal segment distraction for setting the anatomic height of intervertebral space, selection of implant's size, connecting the implant to the holding-distraction instrument by placing implant's teeth in implant's notches,
- the prosthesis of elements of the anterior spinal column contains a perforated sleeve body provided with holes for bone overgrowth, hereinafter referred to as overgrowth holes, and at least one anchoring element on each of the end faces of the body.
- the body has got in its wall at least one through manipulative hole and at least one positioning hole cooperating with it. Longitudinal axes of both holes are parallel to each other.
- the positioning hole is through or blind and made in the internal surface of the body from its internal side.
- the manipulative hole and positioning hole are elongated or are of the shape comparable to a wheel.
- At least one end face or/and body's wall are provided with at least one pair of opposite guidelines.
- a part of at least one end face of the body located at the side of the manipulative hole is inclined at an angle a not greater than 80° relative to the transverse axis of the body.
- the wall of the body from its internal side is preferably provided with a bar, within which a gap is made.
- the wall of the body from its internal side is provided with a thread.
- the positioner is provided with at least one hole, situated within the inside diameter of the body's manipulative hole, cooperating with the known installation instrument.
- the length of the body's manipulative hole corresponds to the distance between extreme locations of the positioner's hole, which is situated within the inside diameter of the manipulative hole.
- the positioner is in the form of a shaped solid, whose shape, depending on the embodiment, is comparable to a hollow barrel, a hollow cylinder, a bowl, or it is in the shape of polygon in a section.
- the positioner has got a longitudinal cut constituting spring arms, which facilitate the placement of the positioner inside the body.
- the situating element in variant embodiments is of the form of a pivot, projection, pin, a slot cooperating with an additional external fastening element, a hook or hump.
- the positioner's situating element in one embodiment is of the length approximate to the positioner's length.
- the positioner's wall from its external side is provided with a thread cooperating with a thread situated on the body's wall from its internal side.
- the positioner is provided with a projection cooperating with a gap made in a body's threshold, securing the positioner against rotating within the body and falling out of it.
- the hole in the positioner's wall is provided with a thread.
- the positioner is provided with an internal protrusion, wherein the positioner's hole is situated.
- the positioner's hole depending on the embodiment, is through or blind.
- the prosthesis-guiding instrument is used for the proper installation of the prosthesis of the anterior spinal column. It is in the form of a rod ended on one side with a holder and on the other side with a shaped working element provided with a sliding segment.
- the working element in the instrument has got a guiding surface provided with at least one guide and a positioning surface situated on the opposite side of the working element, and a bearing surface situated with respect to the positioning surface at an angle ⁇ near or equal to 90° ; the bearing surface is provided with at least one anchoring element.
- the guiding surface and positioning surface of the working element are situated relative to each other at an angle ⁇ not greater than 20°.
- the guiding surface of the working element is in variant embodiments convex or concave.
- a part of the working element provided with the guiding surface in one embodiment is in a section in the form comparable to a channel, wherein both lateral walls are provided withat least one guide situated in parallel to the positioning surface of the guiding instrument.
- the anchoring element of the guiding instrument is fastened to the bearing surface in a separable or inseparable manner.
- the anchoring element is in the form of a spike.
- the bearing surface is provided with teeth.
- the method of implantation of the prosthesis of the anterior spinal column in the intervertebral space consists in performing the following steps: After resection of the vertebral body, in thus surgically prepared intervertebral space, a distance between endplates of vertebrae adjacent to the resected vertebra is measured to select a prosthesis with a proper height, providing that the height of the prosthesis together with anchoring elements is at least equal to the distance between vertebral endplates of adjacent vertebral bodies.
- a prosthesis selected with regard to biomechanical and dimensional aspects is installed on the known installation instrument through the positioner's hole situated in the inside diameter of the body's manipulative hole, therewith the prosthesis is filled with a material enabling bone fusion.
- the guiding instrument is situated in the intervertebral space by resting its working element's bearing surface against the external surface of the vertebral body and placing the guiding instrument's anchoring element into this vertebral body to secure the proper location of the instrument and to restrict its mobility v/ith respect to the vertebral body.
- the installation instrument with the prosthesis installed on it is placed into the intervertebral space, resting the anchoring elements situated on the prosthesis end face unilaterally against the vertebral endplate opposite the vertebra, on which the guiding instrument is situated.
- the prosthesis is placed deep inside the intervertebral space along at least one guide of the guiding instrument cooperating with at least one pair of opposite guidelines made in the prosthesis body.
- distraction of the resected space is performed using the guiding instrument.
- the support and rotation point is located on the anchoring elements situated on body's end face embedded in the vertebral body.
- the solution according to the invention increases precision of implantation, decreases the level of complexity of surgery, shortens the duration of surgery and improves its safety.
- the construction of the prosthesis allows for independent support of the anterior spinal column without the necessity of using additional stabilization, due to the prosthesis shape comparable to the shape of a vertebral body and owing to the fact that the prosthesis is made of a material with properties comparable to bone properties.
- the application of the internal positioner assures an attachment of the installation instrument during implantation through the positioner's hole located in the inside diameter of the body's manipulative hole.
- the prosthesis can also be connected with an additional stabilizer using a screw screwed in the positioner's hole situated in the inside diameter of the body's manipulative hole.
- the positioner is not in contact with the vertebral bones, thus it does not transfer the loads acting on the prosthesis.
- the installation instrument and the guiding instrument, which in the procedure of installation assure distraction of the intervertebral space and precise placement of the prosthesis within the space.
- the construction of the guiding instrument assures accurate and secure introduction of the prosthesis into the intervertebral space.
- Service simplicity and ease of applying the instrumentation assure high precision and quickness of implantation, as well as an improvement in patient safety.
- a wide range of prosthesis' dimensions enables their application in most patients, assuring high ergonomics of surgeon's work. Solutions according to the invention are presented in examples of embodiments, which do not restrict its range, in accompanying figures, where fig.
- fig. 1 illustrates the body and the positioner in an arrangement
- fig. 2 presents the body with a section and the positioner in an arrangement
- fig. 3 illustrates the body with a section and the positioner situated within the body , the positioner being in the form of a hollowed cylinder provided with a thread on a part of the external surface
- fig. 4 presents in a transverse section the body with the positioner situated within it, the positioner being in the form of a hollowed cylinder provided with two situating elements in the form of pivots
- fig. 5 illustrates the body with a section, provided with a blind positioning hole and the positioner situated within the body in the form of a hollowed cylinder, fig.
- FIG. 6 presents in an arrangement the body provided with three elongated oblique manipulative holes and three elongated oblique positioning holes and the positioner in the form similar to a hollowed barrel
- fig. 7 illustrates the body with a section and the positioner situated within the body, having the form of a hollowed cylinder, with the situating element in the form of a slot
- fig. 8 presents the positioner in the form of a hollowed cylinder provided with a hump
- fig. 9 presents the positioner in the form of a hollowed cylinder with the situating element in the form of a slot
- fig. 10 illustrates the positioner in a form similar to a hollowed barrel, fig.
- FIG. 1 1 presents the positioner in the form of a hollowed cylinder, provided with a thread on a part of the wall from the external surface
- fig. 12 presents the positioner in a form similar to a bowl having a transverse section of a polygon
- fig. 13 presents the guiding instrument
- fig. 14 illustrates the working element of the guiding instrument
- fig. 15 presents the working element of the guiding instrument provided with a movable anchoring element in the form of a spike
- fig. 16 presents the working element of the guiding instrument, whose part provided with a guiding surface in a section is in the shape comparable to a channel
- fig. 17 presents the installation instrument, fig.
- fig. 18 presents the guiding instrument with a convex guiding surface introduced into the intervertebral space
- fig. 19 illustrates the method of prosthesis installation with the guiding instrument and the installation instrument
- fig. 20 presents an illustration of the method of prosthesis installation with the use of the guiding instrument with a movable anchoring element in the form of a spike and the installation instrument
- fig. 21 presents the working element of the guiding instrument with the prosthesis located on it
- fig. 22 presents in a longitudinal section the prosthesis installed between two adjacent vertebrae reinforced with elements of external stabilization.
- the prosthesis of the anterior spinal column presented in fig. 1 consists of a body 1 in the form of a perforated sleeve, and a positioner 2 cooperating with the body 1 and situated within.
- the body 1 is provided on every end face 3 with four anchoring elements 4 in the form of spikes and teeth 5.
- a through elongated manipulative hole 6 is made, and from the side of the manipulative hole 6 a through positioning hole 7 is located, whose longitudinal axis is parallel to the longitudinal axis of the manipulative hole 6. Longitudinal axes of the manipulative holes 6 and positioning hole 7 are parallel to the longitudinal axis A of the body 1.
- Each body's 1 end face 3 is cut from the side of the manipulative hole 6 and deflected from the transverse axis of body 1 at an angle a of 42°, which renders it possible in an initial phase of installation to embed and anchor the spikes 4 in the upper and lower vertebral endplates.
- the end face 3 of body 1 is inclined at an angle enabling the introduction of the prosthesis and fitting it to the patient's spine anatomy.
- the inside of the body in a section is in the shape of a wheel.
- the positioner 2 is in the form of a hollowed cylinder. On its external surface there is a situating element 8 in the form of a pivot situated in the positioning hole 7 of the body 1 , limiting mobility of the positioner 2 inside the body 1.
- the positioner 2 is provided with a longitudinal cut 9 forming spring arms 10 and enabling their deflection for a more efficient introduction of the positioner 2 into the inside of the body 1.
- the positioner 2 is provided with an internal protrusion 1 1 , where a threaded through hole 12 is made which is situated within the inside diameter of the body's 1 manipulative hole 6. Hole 12 enables the attachment of the end of the installation instrument, not visible in the figure, and this in turn improves the process of installing the prosthesis in the intervertebral space.
- both the wall of the body 1 and the positioner 2 are provided with overgrowth holes 13.
- each end face 3 of the body 1 is provided with a pair of opposite guidelines 14 cooperating with the guide of the guiding instrument, not visible in the figure.
- Positioner 2 is in the form of a hollowed, longitudinally cut cylinder provided with a situating element 8 in the form of a hook on a strip formed between the cuts. Hole 12 of the positioner 2 is non-threaded.
- a wall of the body 1 from its internal side is provided in a part of its length with a thread 15, whereas the positioner 2 situated inside the body 1 is provided on a part of its wall from its external side with a thread 16 cooperating with the thread 15 on body's 1 wall from its internal side.
- the wall of the body 1 from its internal side is provided with a threshold 17, within which a gap 18 is made which cooperates with a projection 19 made on the wall of positioner 2 from its external side.
- the gap 18 prevents the positioner 2 from rotating inside the body 1 and facilitates placing hole 12 of positioner 2 within the inside diameter of the manipulative hole 6 of body 1.
- the body 1 has got in its wall two through positioning holes 7 located on both sides of the manipulative hole 6.
- Manipulative hole 6 and positioning holes 7 are in the shape similar to a wheel.
- Positioner 2 cooperating with such body 1 is provided with two situating elements 8 in the form of pivots located on both sides of the hole 12 of positioner 2, which are situated in positioning holes 7 of the body 1.
- the positioner's 2 situating element 8 in the form of a pivot is situated in the blind elongated positioning hole 7 performed in body's 1 wall from its internal side.
- a pair of opposite guidelines 20 is made with longitudinal axes B lying in a plane perpendicular to the longitudinal axis A of the body 1.
- the body 1 has got in its wall three through elongated oblique manipulative holes 6 and three elongated oblique through positioning holes 7.
- the wall of body 1 is provided with a pair of opposite guidelines 20 in the shape similar to the letter T.
- Positioner 2 is in the form similar to a hollowed barrel and is provided with a longitudinal cut 9 forming spring arms 10.
- Positioner 2 has got a non- threaded hole 12.
- Positioner 2 is equipped with a situating element 8 in the form of projection with a length corresponding approximately with positioner's 2 length, the situating element 8 is located on positioner's wall from its external side.
- the situating element 8 of positioner 2 is constituted by a through elongated slot for an additional fixing element 21 in the form of a screw situated in the positioning hole 7 of body 1
- Figures 8 - 12 present further embodiments of the positioner.
- the positioner 2 presented in fig. 8 is in the form of a hollow, longitudinally cut cylinder provided with the situating element 8 in the form of a hump on the strip formed between cuts.
- the positioner 2 is provided with an inner thickened area 1 1 , wherein a non-threaded through hole 12 is made.
- the positioner 2 shown in fig. 9 is in the form of a hollowed cylinder.
- the situating element 8 of the positioner 2 is constituted by an elongated through slot.
- the positioner 2 is provided with the inner thickened area 1 1 , wherein a threaded through hole 12 is made.
- the positioner 2 presented in fig. 10 is in the form similar to a hollowed barrel.
- Positioner 2 On its wall from the external side is located the situating element 8 in the form of a pivot.
- the positioner 2 is provided with a longitudinal cut 9 forming spring arms 10.
- Positioner 2 is provided with the inner thickened area 1 , wherein the threaded through hole 12 is made.
- the positioner 2 shown in fig. 1 1 is in the form of a hollowed cylinder provided with a thread 16 in a part of the wall from its external side.
- the positioner 2 has got a through threaded hole 12, and the situating element 8 in the form of a pivot is located on its wall from the external side.
- positioner 2 is in the form similar to a hollowed bowl ended with planes forming a polygon in a transverse section.
- the positioner 2 is provided with the non-threaded hole 12 and the situating element 8 in the form of a pin situated on positioner's 2 wall from its external side.
- all embodiments of positioner 2 are provided with overgrowth holes 13.
- the guiding instrument presented in fig. 13 is in the form of a rod 22 ended with a handle 23 on one of the ends, and a working element 24 on the other end.
- the working element 24 of the guiding instrument presented in fig. 14 has got a convex guiding surface 25, provided with a shaped guide 26, cooperating with guidelines 14, not visible in this figure, located in the end face 3 of the body 1.
- the working element 24 of the guiding instrument has got a positioning surface 27 and a bearing surface 28 situated relative to it at an angle ⁇ equal to 90°; the bearing surface 28 fixes the guiding instrument in a proper position relative to the vertebral body.
- the guiding surface 25 and positioning surface 27 of the working element 24 are situated relative to each other at an angle ⁇ equal to 10° forming a wedge.
- the positioning surface 27 and bearing surface 28 are situated on the other side of the guiding surface 25.
- the working element 24 of the guiding instrument has got a concave guiding surface 25 provided with a shaped guide 26, and the bearing surface 28 of the working element 24 is provided with a movable anchoring element 29 in the form of a spike.
- a movable anchoring element 29 in the form of a spike.
- the movable cylinder 31 has a threaded port 32 in its lateral wall. The port 32 enables screwing the anchoring element 29 into the cylinder 31.
- the anchoring element 29 is in the form of a spike and is provided with a thread 33 on the part located within the working element 24.
- the anchoring element 29 in the form of a spike may move in a swinging way within the inside diameter of the elongated through port 30 due to rotational movement of the cylinder 31 in a range of angle ⁇ changes of ⁇ 4°. This movement takes place only in one plane.
- a part of the working element 24 provided with the guiding surface 25 in a section is in the form comparable to a channel.
- the guides 26 are situated on the edges of both walls in parallel to the positioning surface
- the bearing surface 28 is provided with teeth 34 preventing the bearing surface 28 from uncontrolled move along the vertebral body.
- the installation instrument presented in fig. 17 is constituted by a sleeve 35, within which a tang 36 is located, ended on the one side with a junction 37 enabling provisional connection with the hole 12 in the positioner 2, not visible in the figure, and on the other side with a knob 38 cooperating with the junction 37.
- the end of the sleeve from the side of the junction 37 is provided with a collar 39 with a bearing plane 40.
- the bearing plane 40 of the collar 39 has got a profile similar to the shape of the prosthesis body's 1 , which allows precise adjustment of the instrument to body 1 of the prosthesis, which is not visible in the figure, and prevents the body 1 from moving relative to the installation instrument, thus improving precision of prosthesis installation.
- a holder 41 is mounted on the sleeve 35 underneath the knob 38 .
- Fig. 18 illustrates the guiding instrument introduced into the intervertebral space.
- the working element 24 of the guiding instrument has got a convex guiding surface 25, provided with a shaped guide 26 and positioning surface 27 and a bearing surface 28 situated relative to the positioning surface 27 at an angle ⁇ equal to 90°.
- the positioning surface 27 and bearing surface 28 are situated on the opposite side of the guiding surface 25.
- On the bearing surface 28 is located an immobile anchoring element 29 in the form of a spike.
- the bearing surface 28 of the guiding instrument is rested against the external part of the vertebral body 42, within which the immobile anchoring element 29 in the form of a spike is situated.
- the method of installation of the prosthesis of the anterior spinal column is illustrated in fig. 19.
- a distance between endplates of vertebral bodies 42 adjacent to the resected vertebra is measured to select a prosthesis with a proper height, providing that the height of the prosthesis together with anchoring elements 4 is at least equal to the distance between endplates of adjacent vertebral bodies 42.
- the prosthesis for installation in the intervertebral space consists of a sleeve body 1 whose each end face 3 is provided with four anchoring elements 4 in the form of spikes, teeth 5 and a pair of opposite guidelines 14; the sleeve body 1 has in its wall a through elongated manipulative hole 6, and a through elongated positioning hole 7 and a positioner 2, situated inside the body 1 , in the shape of a hollowed cylinder provided with a threaded hole 12, situated within the inside diameter of the body's 1 manipulative hole 6 and a situating element 8 in the form of a pivot located in the positioning hole 7 of the body 1 , and also a longitudinal cut 9, not visible in the figure, which forms spring arms 10.
- Both the body 1 and positioner 2 are provided with overgrowth holes 13 for filling the prosthesis with a material enabling bone overgrowth.
- the prosthesis that has been selected is installed on a junction 37 of the installation instrument through a threaded positioner's 2 hole 12 situated in body's 1 elongated manipulative hole 6.
- the prosthesis is filled with a material enabling bone fusion, using a mallet of bony fragments.
- the guiding instrument is situated in the intervertebral space.
- the guiding instrument is in the form of a rod 22 ended with a handle 23 on the one side , not visible in the figure, and a working element 24 on the other side.
- the working element 24 of the guiding instrument has got a convex guiding surface 25, provided with a shaped guide 26, cooperating with a pair of opposite guidelines 14 located in the end face 3 of body 1.
- the working element 24 of the guiding instrument has got a positioning surface 27 and a bearing surface 28 situated relative to the positioning surface at an angle ⁇ equal to 90°.
- the bearing surface 28 fixes the guiding instrument in a proper position with respect to the vertebral body.
- On the bearing surface 28 is located an immobile anchoring element 29 in the form of a spike.
- the positioning surface 27 and bearing surface 28 are situated on an opposite side of the guiding surface 25.
- the guiding instrument is introduced to the intervertebral space by resting its bearing surface 28 against the external part of the vertebral body 42 and the guiding instrument's immobile anchoring element 29 in the form of a spike is placed in this vertebral body in order to place the guiding instrument properly and restrict its mobility relative to the vertebral body 42.
- the installation instrument with the prosthesis installed on it is placed in the intervertebral space by unilaterally resting the anchoring elements 4 in the form of spikes situated on the end face 3 of body 1 against the endplate of a vertebra 42 opposite the vertebra 42, on which the guiding instrument is placed.
- the prosthesis is positioned deep inside the intervertebral space along the guide 26 of the guiding instrument cooperating with a pair of opposite guidelines 14 performed in the end face 3 of the prosthesis body 1 , the intervertebral space is simultaneously distracted with the use of the guiding instrument, where the support and rotation point is located on the anchoring elements 4 in the form of spikes situated on the end face 3 of body 1 embedded in the endplate of the vertebral body 42.
- the prosthesis is held in position by means of the installation instrument and the guiding instrument is removed from the intervertebral space.
- the installation instrument is disconnected from the prosthesis.
- Fig. 20 shows an example of installation of the prosthesis with the use of the guiding instrument, whose working element 24 has got a concave guiding surface 25 provided with a shaped guide 26 cooperating with a pair of opposite guidelines 14 performed in the end face 3 of body 1.
- a movable anchoring element 29 in the form of a spike is located on the bearing surface 28 of the guiding instrument.
- Within the working element 24 of the guiding instrument in a plane approximately perpendicular to the guiding surface 28 there is an elongated port 30, within which a rotationally movable cylinder 31 is located, having in its lateral wall a threaded port 32.
- the port 32 enables screwing the anchoring element 29 in the form of a spike into the cylinder 31 .
- the anchoring element is provided with a thread 33 on the part located within the working element 24.
- the anchoring element 29 in the form of a spike may move in a swinging way within the inside diameter of the elongated through port 30 due to rotational movement of the cylinder 31 in a range of angle ⁇ changes of ⁇ 4°. This movement takes place only in one plane.
- the guiding instrument is introduced to the intervertebral space by resting its bearing surface 28 against the external part of the vertebral body 42 and the movable anchoring element 29 in the form of a spike is placed into this vertebral body 42.
- the installation instrument with the prosthesis installed on it is positioned in the intervertebral space by unilaterally resting the anchoring elements 4 in the form of spikes situated on the end face 3 of body 1 against the endpiate of the vertebra 42 opposite the vertebra 42, on which the guiding instrument is placed.
- the guiding surface 25 of the working element 24 of the guiding instrument is deflected from the vertebral body 42 and the placement of the prosthesis into the intervertebral space starts along the guide 26 of the guiding instrument cooperating with a pair of opposite guidelines 14 located in the end face 3 of body 1.
- the guiding surface 25 of the guiding instrument's working element 24 is inclined towards the vertebral body 42 and the prosthesis is situated deep inside the intervertebral space.
- Fig. 21 illustrates the guiding instrument, whose working element 24 has got a convex guiding surface 25 provided with a shaped guide 26, cooperating with a pair of opposite guidelines 14 located in end faces 3 of body .
- the prosthesis is additionally fixed with an external plate stabilizer 43 using a fixing element 44 in the form of a screw driven into the positioner's 2 hole 12 situated in the manipulative hole 6 of body 1.
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Transplantation (AREA)
- Neurology (AREA)
- Heart & Thoracic Surgery (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Cardiology (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Physical Education & Sports Medicine (AREA)
- Prostheses (AREA)
- Surgical Instruments (AREA)
Abstract
Description
Claims
Priority Applications (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
ES11710579.1T ES2613065T3 (en) | 2010-03-03 | 2011-02-11 | Spine prosthesis |
MX2012009947A MX2012009947A (en) | 2010-03-03 | 2011-02-11 | Prosthesis for spinal column, instrument for its guiding and method for implantation thereof. |
EP11710579.1A EP2542188B1 (en) | 2010-03-03 | 2011-02-11 | Prosthesis for spinal column |
CN201180022079.2A CN102869322B (en) | 2010-03-03 | 2011-02-11 | Prosthesis for spinal column, instrument for its guiding and method for implantation thereof |
BR112012022226A BR112012022226A2 (en) | 2010-03-03 | 2011-02-11 | anterior spinal prosthesis, prosthetic guide instrument and method of installation |
RU2012137429/14A RU2570967C2 (en) | 2010-03-03 | 2011-02-11 | Anterior spinal implant, implant guide instrument and method for installing it |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PL390601A PL217567B1 (en) | 2010-03-03 | 2010-03-03 | Prosthesis of anterior spinal column, prosthesis guiding tool and method for the implantation thereof |
PLP-390601 | 2010-03-03 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2011108950A1 true WO2011108950A1 (en) | 2011-09-09 |
Family
ID=44065585
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/PL2011/000013 WO2011108950A1 (en) | 2010-03-03 | 2011-02-11 | Prosthesis for spinal column, instrument for its guiding and method for implantation thereof |
Country Status (9)
Country | Link |
---|---|
US (1) | US8753400B2 (en) |
EP (1) | EP2542188B1 (en) |
CN (1) | CN102869322B (en) |
BR (1) | BR112012022226A2 (en) |
ES (1) | ES2613065T3 (en) |
MX (1) | MX2012009947A (en) |
PL (1) | PL217567B1 (en) |
RU (1) | RU2570967C2 (en) |
WO (1) | WO2011108950A1 (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2535023B1 (en) * | 2011-06-14 | 2017-10-11 | Biedermann Technologies GmbH & Co. KG | Intervertebral implant |
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WO2010135537A2 (en) * | 2009-05-20 | 2010-11-25 | Synthes Usa, Llc | Patient-mounted retraction |
DE102010047901B4 (en) * | 2010-10-11 | 2019-01-10 | Heinrich Böhm | Implant for the spine and operating instrument |
US8940030B1 (en) | 2011-01-28 | 2015-01-27 | Nuvasive, Inc. | Spinal fixation system and related methods |
US9848994B2 (en) * | 2011-09-16 | 2017-12-26 | Globus Medical, Inc. | Low profile plate |
CN104394805B (en) * | 2012-07-04 | 2017-03-01 | 德普伊爱尔兰无限公司 | For orthopedic measuring apparatuss |
US9138325B2 (en) * | 2012-07-11 | 2015-09-22 | Globus Medical, Inc. | Lamina implant and method |
AU2013293221B2 (en) * | 2012-07-23 | 2017-09-07 | Zimmer, Inc. | Porous metal dental implant |
US9615931B2 (en) * | 2015-03-20 | 2017-04-11 | Globus Medical, Inc. | Surgical plate systems |
US10034768B2 (en) * | 2015-09-02 | 2018-07-31 | Globus Medical, Inc. | Implantable systems, devices and related methods |
CN109077835A (en) * | 2018-10-26 | 2018-12-25 | 北京爱康宜诚医疗器材有限公司 | Centrum prosthese |
CN113974926B (en) * | 2021-12-24 | 2022-05-03 | 北京爱康宜诚医疗器材有限公司 | Prosthesis assembly |
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Also Published As
Publication number | Publication date |
---|---|
EP2542188A1 (en) | 2013-01-09 |
RU2570967C2 (en) | 2015-12-20 |
PL390601A1 (en) | 2011-09-12 |
US20110218628A1 (en) | 2011-09-08 |
CN102869322B (en) | 2015-07-08 |
RU2012137429A (en) | 2014-04-10 |
ES2613065T3 (en) | 2017-05-22 |
US8753400B2 (en) | 2014-06-17 |
PL217567B1 (en) | 2014-07-31 |
BR112012022226A2 (en) | 2016-07-05 |
MX2012009947A (en) | 2012-10-05 |
CN102869322A (en) | 2013-01-09 |
EP2542188B1 (en) | 2016-11-02 |
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