US20080119932A1 - Method and a Device for Total Spinal Disc Replacement - Google Patents

Method and a Device for Total Spinal Disc Replacement Download PDF

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Publication number
US20080119932A1
US20080119932A1 US11/722,908 US72290805A US2008119932A1 US 20080119932 A1 US20080119932 A1 US 20080119932A1 US 72290805 A US72290805 A US 72290805A US 2008119932 A1 US2008119932 A1 US 2008119932A1
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US
United States
Prior art keywords
intervertebral prosthesis
central axis
prosthetic
intervertebral
axis
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US11/722,908
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English (en)
Inventor
Beat Lechmann
Robert Frigg
Paul W. Pavlov
Roger Buerki
Gregor Feigenwinter
Andreas Appenzeller
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
DePuy Spine LLC
DePuy Synthes Products Inc
Original Assignee
Synthes USA LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=35998566&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=US20080119932(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Synthes USA LLC filed Critical Synthes USA LLC
Assigned to SYNTHES (U.S.A.) reassignment SYNTHES (U.S.A.) ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SYNTHES GMBH
Assigned to SYNTHES GMBH reassignment SYNTHES GMBH ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: LECHMANN, BEAT, BUERKI, ROGER, FEIGENWINTER, GREGOR, APPENZELLER, ANDREAS, PAVLOV, PAUL W., FRIGG, ROBERT
Publication of US20080119932A1 publication Critical patent/US20080119932A1/en
Assigned to SYNTHES USA, LLC reassignment SYNTHES USA, LLC CHANGE OF NAME (SEE DOCUMENT FOR DETAILS). Assignors: SYNTHES (U.S.A.)
Assigned to DEPUY SPINE, LLC reassignment DEPUY SPINE, LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SYNTHES USA, LLC
Assigned to HAND INNOVATIONS LLC reassignment HAND INNOVATIONS LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DEPUY SPINE, LLC
Assigned to DePuy Synthes Products, LLC reassignment DePuy Synthes Products, LLC CHANGE OF NAME (SEE DOCUMENT FOR DETAILS). Assignors: HAND INNOVATIONS LLC
Assigned to HAND INNOVATIONS LLC reassignment HAND INNOVATIONS LLC CORRECTIVE ASSIGNMENT TO CORRECT THE INCORRECT APPL. NO. 13/486,591 PREVIOUSLY RECORDED AT REEL: 030359 FRAME: 0001. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Assignors: DEPUY SPINE, LLC
Assigned to DEPUY SPINE, LLC reassignment DEPUY SPINE, LLC CORRECTIVE ASSIGNMENT TO CORRECT THE INCORRECT APPLICATION NO. US 13/486,591 PREVIOUSLY RECORDED ON REEL 030358 FRAME 0945. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Assignors: SYNTHES USA, LLC
Abandoned legal-status Critical Current

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    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389The prosthesis being coated or covered with a particular material
    • A61F2310/00592Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
    • A61F2310/0073Coating or prosthesis-covering structure made of compounds based on metal carbides
    • A61F2310/00748Coating made of titanium carbide

Definitions

  • the state of the art concerning total spinal disc replacement device insertion is the anterior approach, i.e. true anterior, anterolateral (oblique) or true lateral.
  • the surgeon decides between transperitoneal or retroperitoneal approaches, depending on the treated level or his personal experience.
  • major vessels e.g. aorta, vena cava
  • the anterior approach to the spine is often performed in the presence of vascular surgeons thereby causing extra costs.
  • a prosthetic device for transforaminal insertion into an intervertebral space is known from US 2004/0225365 EISERMANN.
  • This known prosthesis comprises two components having an articulating surface each in order to permit articulating motion between the first and second components and consequently of the adjoining vertebrae.
  • the transforaminal path disclosed might cause potential damage to important anatomical structures such as nerve roots, dura, ligamentum flavum and interspinous ligaments.
  • the above object is achieved by means of an extraforaminal approach including an access portal in the Fibrocartilago Intervertebralis between the anterior and posterior longitudinal ligaments for removing the affected intervertebral disc as well as for insertion of a total disc prosthesis.
  • the key element of the extraforaminal approach to the spinal disc is a path in front of the transverse processes (Processus Transversus).
  • the disc material is removed with a surgical device through a protection sleeve.
  • a protection sleeve This permits the advantage that the use of a protection sleeve during removing the disc material allows a better protection of the surrounding soft tissue.
  • the access portal is cut at a distance X>0 apart from the anterior longitudinal ligament and the posterior longitudinal ligament, therewith permitting the advantage that the anterior longitudinal ligament and the posterior longitudinal ligament remain intact in order to stabilize the treated segment of the vertebra.
  • the distance X amounts between 2 mm and 38 mm.
  • the width W of the access portal is between 8 mm and 36 mm.
  • the area A of the access portal is between 24 mm 2 and 684 mm 2 and the height is preferably between 3 and 19 mm.
  • the step of distracting of the vertebral bodies adjoining the disc space to be treated is performed through the protection sleeve.
  • the distraction of the vertebral bodies adjoining the disc space to be treated is performed by slightly bending a distractor in order to keep the view to the situs free for the surgeon.
  • the total disc replacement procedure is performed without dissecting the facet joints.
  • the total disc replacement procedure is performed without dissecting the transverse processes.
  • the access to the intervertebral space to be treated is essentially straight. This allows the advantage that due to the almost straight access the use of essentially straight instruments e.g. for cleaning the endplates of the adjacent vertebral bodies or other surgical actions is possible.
  • the incision is reduced to a tube.
  • the risk of damaging the neural structures is reduced by means of passing (not approaching) the spinal cord and locating, mobilising and marking the nerve root.
  • an intervertebral prosthesis which essentially comprises a first and a second prosthetic component each having an apposition surface disposed transversely to the central axis and apt for contacting the end plate of an adjoining vertebral body each. Furthermore, said first and second prosthetic components are connected by means of an articulation. When viewed parallel to said central axis said first and second prosthetic components have an elongated shape with a major axis and a transverse minor axis, whereby said central axis, major axis and transverse minor axis intersect each other and said central axis and transverse minor axis defining a middle plane.
  • Said first and second prosthetic component have a cross-sectional area orthogonal to said central axis which is essentially oval or elliptical and said cross-sectional area comprises at least a first and a second concavity lying on different side of the middle plane and on the same side of the major axis.
  • said cross-sectional area of said first and second prosthetic component is kidney shaped with an enlargement arranged essentially symmetrical to said the middle plane.
  • said at least two concavities have an essentially semi-elliptical or semi-oval shape.
  • said at least two convavities are disposed essentially symmetrical to said middle plane.
  • said first and second prosthetic component have a length H measured parallel to said major axis and wherein each of said at least two concavities has a width W measured parallel to said major axis, said width W amounting to between 15% and 35% of said length H.
  • said first and second prosthetic component have a maximum width B measured parallel to said transverse minor axis and wherein each of said at least two concavities has a depth T measured parallel to said transverse minor axis, said depth T amounting to between 5% and 25% of said maximum width B.
  • said cross-sectional area of said first and second prosthetic components has an essentially elliptical periphery with a smaller radius of curvature at the first subsidiary vertex than at the second subsidiary vertex of said periphery.
  • said first subsidiary vertex is on the same side of said major axis as said at least two concavities.
  • the ratio of the length H of the prosthetic components to the width B thereof is between 3:1 and 5:1.
  • said articulation is configured as a ball-and-socket joint comprising a spherical cap connected to one of the first and second prosthetic components and congruent to said spherical cap a spherical recess in the other of said first and second prosthetic components.
  • the intervertebral prosthesis is realised in two pieces, i.e. the spherical cap is made in one piece with one of the two prosthetic components.
  • the intervertebral prosthesis is realised in three pieces, so that the spherical cap forming the third piece is connectable with one of the two prosthetic components.
  • the advantage of this design is to be seen essentially in the fact that the plate and the spherical cap may be realised by using different materials, so that it is possible to achieve optimal sliding properties for the articular surfaces.
  • Preferred materials for the plates are titanium or a titanium alloy as well as PEEK or coated variants, and for the spherical cap highly crosslinked polyethylene (X-UHMWPE), an alloy of cobalt and chrome, or a ceramic material.
  • the intervertebral prosthesis is realised in at least three pieces and comprises an articular shell including the recess, whereby said articular shell is attachable to one of said first and second prosthetic components as a third piece.
  • the spherical cap and the articular shell consist of a material combination made of metal and plastic.
  • the advantages of this embodiment are that it is possible to use proven combinations of joint replacement materials such as, for example, highly crosslinked polyethylene (X-UHMWPE) and an alloy of cobalt and chrome. Further advantages are to be seen in the fact that low frictional forces are achievable for the relative displacement of the articular surfaces and that a compensation of axial impact loads can be achieved.
  • a ceramic-to-ceramic articulation is used.
  • the surfaces of the spherical cap and the recess are coated with titanium carbide or with amorphous carbon (ADLC) therewith permitting a substantial reduction of the coefficient of friction.
  • ADLC amorphous carbon
  • At least the spherical cap is made of a memory metal or of a material capable of swelling (e.g. hydrogels).
  • at least the spherical cap is made of a flowable, thermosetting material.
  • the monomers, comonomers, homopolymers, oligomers, or mixtures which contain such thermosetting, flowable substances may suitably be selected from the group of:
  • polyethylene glycols preferably polyethylene glycol(di)-acrylates
  • n-vinylpyrrolidones preferably vinyl alcohols
  • vinyls preferably vinyl alcohols
  • the polymers thus obtained may be widely varied as regards their elasticity.
  • the advantages of these designs are to be seen essentially in the fact that due to the reduced volume of the joint, the insertion of the intervertebral prosthesis becomes less invasive, the increased volume being best suited for achieving an optimal articular function.
  • first prosthetic component is selected from a first kit of at least M ⁇ 2 first prosthetic components and the second prosthetic component is selected from a second kit of at least N ⁇ 2 second prosthetic components.
  • Said first and second kit may comprise first and second prosthetic components being provided with different heights, articulation radii or locations of the centre of the respective radii, i.e. the center of rotation.
  • said first and second prosthetic component each comprise an intermediate surface, said first and second intermediate surfaces facing each other. At least the first or second intermediate surface is provided with at least one cavity with an undercut being located at the first or/and second lateral end of said first and second prosthetic components, said cavity with an undercut being apt for acceptance of an anchoring member of an implant holder.
  • the implant holder according to the invention is provided with a sleeve and an anchoring member, e.g. a hook member being insertable into the cavity and undercut and being displaceably disposed in the central bore of the sleeve, said implant holder further having a front end being provided with a fore-part which is adapted to the lateral ends of the first and/or second prosthetic component of an intervertebral prosthesis according to invention. Furthermore, the implant holder is provided with a fastening mechanism permitting to pull the anchoring member towards the sleeve such pressing the lateral end of the intervertebral prosthesis against the fore-part.
  • an anchoring member e.g. a hook member being insertable into the cavity and undercut and being displaceably disposed in the central bore of the sleeve
  • said implant holder further having a front end being provided with a fore-part which is adapted to the lateral ends of the first and/or second prosthetic component of an intervertebral prosthesis
  • FIG. 1 is a cross-section through the spinal column orthogonal to the longitudinal axis of the spinal column;
  • FIG. 2 is a plane view to the back of a patient in prone position
  • FIG. 3 is a plane view to the dorsal muscle configuration of a patient
  • FIG. 4 is a cross-section through the body of a patient orthogonal to the longitudinal axis of the spinal column and seen from cranial;
  • FIG. 5 is a perspective view to the lumbar part of the spinal column whereby a Kirschner wire is inserted into the affected spinal disc according to one step of an embodiment of the method of the present invention
  • FIG. 6 is a perspective view to the lumbar part of the spinal column whereby a trockar and a protection sleeve are slid over the Kirschner wire according to one step of an embodiment of the method of the present invention
  • FIG. 7 is a perspective view to the lumbar part of the spinal column whereby a cutting device is slid through the protection sleeve according to one step of an embodiment of the method of the present invention
  • FIG. 8 is a perspective view to the lumbar part of the spinal column whereby an access portal is being cut into the affected disc space;
  • FIG. 9 is a perspective view to the lumbar part of the spinal column together with a distractor according to one step of an embodiment of the method of the present invention.
  • FIG. 10 is a perspective view to the lumbar part of the spinal column together with an intervertebral prosthesis and an implant holder according to one step of an embodiment of the method of the present invention
  • FIG. 11 is a lateral view to the portion of the spinal column together with the inserted intervertebral prosthesis
  • FIG. 12 is a view from anterior to the portion of the spinal column together with the inserted intervertebral prosthesis
  • FIG. 13 is a top view of an embodiment of the intervertebral prosthesis according to the invention.
  • FIG. 14 is a front view of the embodiment of FIG. 13 ;
  • FIG. 15 is a lateral view of the embodiment of FIGS. 13 and 14 ;
  • FIG. 16 is a perspective view of the second prosthetic component of the embodiment of FIGS. 13-15 ;
  • FIG. 17 is a cross-section along the major axis of the second prosthetic component of FIG. 16 ;
  • FIG. 18 is a magnified view of one lateral end of the second prosthetic component of FIGS. 16 and 17 ;
  • FIG. 19 is a perspective view of the second prosthetic component of FIGS. 16-18 together with the leading end of an embodiment of the implant holder according to the invention.
  • FIG. 20 is a perspective view of the second prosthetic component of FIGS. 16-18 together with a portion of the sleeve of an embodiment of the implant holder according to the invention.
  • FIGS. 11 and 12 illustrate the situation after completion of the surgical process, i.e. an intervertebral prosthesis 30 has been inserted between the two vertebral bodies 10 ; 11 .
  • the intervertebral prosthesis 30 shown comprises an upper and a lower apposition member 24 ; 25 the outer surfaces of which abut the end plates of the vertebral bodies 10 ; 11 .
  • the intervertebral prosthesis 30 comprises an articulation 26 jointedly connecting the upper and lower apposition member 24 ; 25 such allowing articulating motion between the two apposition members 24 ; 25 and consequently of the two adjoining vertebrae 10 ; 11 .
  • FIGS. 13-15 illustrate an embodiment of the intervertebral prosthesis 100 comprising a first prosthetic component 101 , a second prosthetic component 102 and an articulation 106 articulatedly connecting said first and second prosthetic component 101 ; 102 .
  • the first and second prosthetic component 101 ; 102 comprise a first apposition surface 107 , respectively a second apposition surface 108 , whereby said first apposition surface 107 is configured for abutting the base plate of a first intervertebral body 10 contacting the intervertebral prosthesis 100 on top and said second apposition surface 108 is configured for abutting the cover plate of a second intervertebral body 11 contacting the intervertebral prosthesis 100 at the bottom.
  • the articulation 106 is configured as a ball-and-socket joint, said ball-and-socket joint comprising a spherical cap 112 at the second prosthetic component 102 and congruent to said spherical cap 112 a spherical recess 111 in the first prosthetic component 101 .
  • Each of the first and second apposition surfaces 108 ; 109 is disposed transversely to the central axis 103 .
  • said first and second prosthetic components 101 ; 102 have an elongated shape with a major axis 127 and a transverse minor axis 128 , whereby said central axis 103 , major axis 127 and transverse minor axis 128 intersect each other.
  • Said central axis 103 and said transverse minor axis 128 further define a middle plane 126 .
  • said first and second prosthetic component 101 ; 102 have a cross-sectional area orthogonal to said central axis 103 which is essentially elliptical and comprises two concavities 125 lying on different sides of said middle plane 126 and on the same side of said major axis 127 .
  • the two concavities 125 are disposed symmetrically to said middle plane 126 such that one of said two concavities 125 is arranged in a first quadrant of a circle the centre of which coincides with the point of intersection of the major axis 127 , the transverse minor axis 128 and the central axis 103 and the circumference of which is tangent to the periphery 129 of said cross-sectional area at the principal vertices.
  • the second of said two concavities 125 is arranged in a clockwise succeeding, second quadrant of said circle.
  • the two concavities 125 have an essentially semi-elliptical shape and have a depth T measured parallel to said transverse minor axis 128 amounting to about 5% of the maximum width B of said first and second prosthetic components 101 ; 102 .
  • the first and second prosthetic component 101 ; 102 each comprise an intermediate surface 109 ; 110 , said first and second intermediate surfaces 109 ; 110 facing each other.
  • the second intermediate surface 110 is provided with two cavities 131 with an undercut 132 being located at the first and second lateral end 133 ; 134 of said first and second prosthetic components 101 ; 102 whereby said cavities 131 with undercut 132 are apt for acceptance of an anchoring member 141 of an implant holder 22 (FIG. 19 , 20 ) whereby the surgeon may select the respective cavity 133 in case of approaching the intervertebral space from the left or from the right side.
  • FIGS. 19 and 20 illustrate an embodiment of the implant holder 22 which is provided with a sleeve 140 and an anchoring member 141 , with a hook member at the front end.
  • the anchoring member 141 may be inserted into the cavity 131 and undercut 132 and is displaceably disposed in the central bore of the sleeve 140 .
  • the implant holder 22 further has a front end 142 being provided with a fore-part 143 which is adapted to the lateral ends 133 , 134 ( FIG. 16 ) of the first and/or second prosthetic component 101 , 102 .
  • the implant holder 22 is provided with a fastening mechanism (not shown) permitting to pull the anchoring member 141 into the sleeve 140 such pressing the lateral end 133 of the intervertebral prosthesis against the fore-part 143 .
  • the sleeve 140 is curved in order to permit an insertion of the intervertebral prosthesis 100 along an extraforaminal path.
US11/722,908 2004-12-28 2005-12-27 Method and a Device for Total Spinal Disc Replacement Abandoned US20080119932A1 (en)

Applications Claiming Priority (3)

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CH02160/04A CH697330B1 (de) 2004-12-28 2004-12-28 Zwischenwirbelprothese.
CH2160/04 2004-12-28
PCT/CH2005/000776 WO2006069464A2 (en) 2004-12-28 2005-12-27 A method and a device for total spinal disc replacement

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US20080119932A1 true US20080119932A1 (en) 2008-05-22

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US11/722,905 Active 2027-05-26 US10182924B2 (en) 2004-12-28 2005-12-27 Prosthetic joint with articulating surface layers comprising ADLC
US11/722,903 Abandoned US20080103597A1 (en) 2004-12-28 2005-12-27 Intervertebral Prosthesis
US11/722,908 Abandoned US20080119932A1 (en) 2004-12-28 2005-12-27 Method and a Device for Total Spinal Disc Replacement

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US11/722,903 Abandoned US20080103597A1 (en) 2004-12-28 2005-12-27 Intervertebral Prosthesis

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US (3) US10182924B2 (ja)
EP (3) EP1833523B1 (ja)
JP (3) JP4965459B2 (ja)
KR (3) KR101266678B1 (ja)
CN (3) CN101094627B (ja)
AT (2) ATE475380T1 (ja)
AU (3) AU2005321740B2 (ja)
BR (3) BRPI0518730A2 (ja)
CA (3) CA2592421C (ja)
CH (1) CH697330B1 (ja)
DE (1) DE602005022627D1 (ja)
ES (1) ES2347980T3 (ja)
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