US20120290094A1 - Minimally invasive expanding spacer and method - Google Patents
Minimally invasive expanding spacer and method Download PDFInfo
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- US20120290094A1 US20120290094A1 US13/558,060 US201213558060A US2012290094A1 US 20120290094 A1 US20120290094 A1 US 20120290094A1 US 201213558060 A US201213558060 A US 201213558060A US 2012290094 A1 US2012290094 A1 US 2012290094A1
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- United States
- Prior art keywords
- spacer
- linkages
- height
- orientation
- pull arm
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-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
- A61B17/025—Joint distractors
-
- 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
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
- A61B17/0206—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors with antagonistic arms as supports for retractor elements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/28—Surgical forceps
- A61B17/2804—Surgical forceps with two or more pivotal connections
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
- A61B17/025—Joint distractors
- A61B2017/0256—Joint distractors for the spine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/06—Measuring instruments not otherwise provided for
- A61B2090/061—Measuring instruments not otherwise provided for for measuring dimensions, e.g. length
-
- 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
- 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
- A61F2002/30471—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
-
- 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
- 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
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30537—Special structural features of bone or joint prostheses not otherwise provided for adjustable
- A61F2002/3055—Special structural features of bone or joint prostheses not otherwise provided for adjustable for adjusting length
-
- 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
- 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
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30579—Special structural features of bone or joint prostheses not otherwise provided for with mechanically expandable devices, e.g. fixation devices
-
- 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
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30621—Features concerning the anatomical functioning or articulation of the prosthetic joint
- A61F2002/30624—Hinged joint, e.g. with transverse axle restricting the movement
-
- 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
- A61F2220/0091—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
Definitions
- the indicator gauge 90 may be positioned at a variety of locations along the delivery device 80 . In one embodiment, indicator gauge 90 is positioned in proximity to the scroll 77 . The markings 121 or indicator 130 may be positioned on the scroll 77 , with the other positioned on a support 79 that extends along the second section 84 . The indicator gauge 90 may also be positioned between the collar 73 and the receptacle 74 , or between the receptacle 74 and the first section 82 .
- a linkage axis L is formed by the line extending through the linkage 40 .
- linkage axis L extends through the points of intersection with the plate 50 and pull arm 30 .
- a link angle ⁇ is formed by the linkage axis L and the centerline C. In the embodiment illustrated in FIG. 1 , the link angle ⁇ is greater than zero when the spacer 10 is in the dosed orientation. In one embodiment, a link angle ⁇ greater than 0° in the dosed orientation has been determined to facilitate opening the spacer 10 .
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Surgery (AREA)
- Neurology (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Molecular Biology (AREA)
- Medical Informatics (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Vascular Medicine (AREA)
- Prostheses (AREA)
Abstract
A minimally invasive spacer for positioning between vertebral members. The spacer is adjustable between a first orientation having a reduced size to facilitate insertion between the vertebral members. A second orientation has an enlarged size for contacting the vertebral members. The spacer includes linkages that are attached to a pair of plates. A pull arm is operatively connected to the linkages for adjusting the spacer from the first orientation to the second orientation. A indicator gauge indicates the height of the spacer.
Description
- This application is a continuation-in-part of previously filed U.S. patent application Ser. No. 10/817,024 filed on Apr. 2, 2004, which itself is a continuation-in-part of previously filed U.S. patent application Ser. No. 10/178,960 filed on Jun. 25, 2002.
- Various devices are used for controlling the spacing between vertebral members. These devices may be used on a temporary basis, such as during surgery when it is necessary to access the specific surfaces of the vertebral member. One example includes preparing the endplates of a vertebral member. The devices may also remain permanently within the patient to space the vertebral members.
- It is often difficult to position the device between the vertebral members in a minimally invasive manner. A device that is small may be inserted into the patient and between the vertebral members in a minimally invasive manner. However, the small size may not be adequate to effectively space the vertebral members. A larger device may be effective to space the vertebral members, but cannot be inserted into the patient and between the vertebral members in a minimally invasive manner.
- The present invention is directed to a minimally invasive spacer for spacing vertebral members. The spacer is positionable between a closed orientation to fit between the vertebral members. The spacer may be expanded to a variety of sizes larger than the closed orientation to space the vertebral members as desired. A height gauge may be positioned at a point away from the spacer to indicate a height of the spacer.
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FIG. 1 is a perspective view of a spacer in a dosed orientation according to one embodiment of the present invention; -
FIG. 2 is a perspective view of a spacer in an opened orientation according to one embodiment of the present invention; -
FIG. 3 is a perspective view of a pull arm according to one embodiment of the present invention; -
FIG. 4 is a is a perspective view of one embodiment of the spacer and attached delivery device constructed according to one embodiment of the present invention; -
FIG. 5 is a perspective view of one embodiment of the spacer, delivery device, and force mechanism constructed according to one embodiment of the present invention; -
FIG. 6 is a perspective view of another embodiment of the spacer in a dosed orientation; -
FIG. 7 is a perspective view of another embodiment of the spacer in an open orientation; -
FIG. 8 is a perspective view of another spacer embodiment in a dosed orientation; -
FIG. 9 is a perspective view of the spacer ofFIG. 8 in a partially-open orientation; -
FIG. 10 is a perspective view of the spacer ofFIG. 9 in an open orientation; -
FIG. 11 is a schematic diagram corresponding to the spacer ofFIG. 8 in the dosed orientation illustrating the angles formed between a distal link and a proximal link; -
FIG. 12 is a schematic diagram corresponding to the spacer ofFIG. 9 in the partially-opened orientation illustrating the angles formed between a distal link and a proximal link; -
FIG. 13 is a schematic diagram corresponding to the spacer ofFIG. 10 in the open orientation illustrating the angles formed between a distal link and a proximal link; and -
FIG. 14 is a perspective view of an alternative embodiment with a push link within the slot of the pull arm. -
FIG. 15 is a partial perspective view illustrating a height gauge according to one embodiment. - The present invention is directed to a minimally invasive spacer, generally illustrated as 10, for positioning between vertebral members. The
spacer 10 is adjustable between a variety of sizes between a first orientation and a second orientation. The first orientation is illustrated inFIG. 1 and has a reduced size to facilitate insertion into the patient and between the vertebral members. A second orientation, as illustrated inFIG. 2 , has an enlarged size for contacting and spreading the vertebral members. Thespacer 10 includeslinkages 40 attached to a pair ofplates 50. Apull arm 30 operatively connects to thelinkages 40 to adjust thespacer 10 at positions between the first orientation and the second orientation. Adelivery device 80 is attached to thespacer 10 to deliver thespacer 10 between the vertebral members. Thedelivery device 80 may be detachable to be removed from thespacer 10 once positioned between the vertebral members. -
Spacer 10 may include a number oflinkages 40 positioned between theplates 50 depending upon the application. Eachindividual linkage 40 mates with acomplimentary linkage 40 to provide movement to thespacer 10. In embodiments illustrated inFIGS. 1 and 2 ,spacer 10 includes two pairs oflinkages 40 on a first side of thepull arm 30, and another two pairs oflinkages 40 on a second side of thepull arm 30 for a total of four pairs of linkages, or eight total linkages. In another embodiment (not illustrated),spacer 10 includes only two pairs oflinkages 40, or four total linkages. Various numbers oflinkages 40 may be included within the present invention depending upon the specific requirements of the spacer and necessary amount of disc space load. In one embodiment,linkages 40 are independent and individually spaced apart. In another embodiment,linkages 40 are paired together, but adjacent linkage pairs do not contact. - Each
linkage 40 has an elongated shape with anaperture 42 adjacent to each end to receive pins. The ends of eachlinkage 40 may have a variety of shapes and configurations. In embodiments illustrated inFIGS. 1 and 2 , each end is substantially rounded. In the embodiments illustrated inFIGS. 6 and 7 , each end has a partially rounded section with a linear edge extending along one side of thelinkage 40. In one embodiment,teeth 44 are positioned about at least one end of eachlinkage 40.Teeth 44 are sized to mate withcomplimentary teeth 44 onadjacent linkages 40.Teeth 44 may be positioned along the ends of thelinkages 40, or may also extend along the elongated length. In the embodiments illustrated inFIGS. 1 and 2 ,teeth 44 are positioned along one side of the rounded edge. In the embodiments ofFIGS. 6 and 7 ,teeth 44 extend along only a section of each end and further down along the length. - In one embodiment,
linkages 40 are shaped to compliment adjacent linkages. In one embodiment illustrated inFIG. 2 , a linkagefirst side 40 a includes arecessed section 47 and an extendedsection 46. Anedge 45 extends across the length of thelinkage 40 defining therecessed section 47 andextended section 46. A linkagesecond side 40 b may have a variety of configurations, such as substantially flat. Thelinkages 40 overlap with thefirst sides 40 a mating together in the closed orientation. The complimentary shapes give thelinkages 40 a smaller profile thus reducing the dimensions of thespacer 10 as illustrated inFIG. 1 . -
Plates 50 are positioned on a first and second side of thespacer 10 to contact the vertebral members.Plates 50 include acontact surface 52 having a surface area to distribute the disc space load created by thespacer 10 across a large region of the vertebral members. In one embodiment, thecontact surface 52 is about 16 mm in length by about 8 mm in width. The dimensions of thecontact surface 52 may vary depending upon the construction of thespacer 10. By way of example, embodiments illustrated inFIGS. 1 and 2 have acontact surface 52 with a substantially hourglass shape. In embodiments illustrated inFIGS. 6 and 7 ,contact surface 52 has a substantially rectangular shape. In embodiments illustrated inFIGS. 1 and 2 , thecontact surface 52 is substantially flat. In another embodiment, thecontact surface 52 may be rounded. In one embodiment,plate 50 has a width equal to the overall width of thespacer 10. In another embodiment,plate 50 has a width less than the overall width of thespacer 10. -
Linkages 40 may connect to theplates 50 in a number of different positions. In one embodiment, anedge 56 ofcontact surface 52 has a width for receiving an aperture for receiving a pin. In embodiments illustrated inFIGS. 1 and 2 ,plates 50 include an outwardly extendingrib 54.Rib 54 is sized with an aperture therein to receive the pin. - In one embodiment,
plate 50 includes a front 57 which is angled or rounded inward relative to thecontact surface 52. In one embodiment,front 57 has a length such that distal ends of the first andsecond plates 50 contact each other in the closed orientation. In another embodiment,front 57 extends a lesser distance to cover only a portion of thelinkages 40 and pullarm 30 when in the closed orientation. - Pull
arm 30 moves thelinkages 40 from the closed orientations through the open orientations. One embodiment of thepull arm 30 is illustrated inFIG. 3 and includes an elongated body having anaperture 36 and aslot 37 for receiving pins. Anose 34 on the distal end may have a rounded or angled shape. As illustrated inFIG. 1 , the rounded or angled shape facilitates insertion of thespacer 10 between the vertebral members. In one embodiment as illustrated inFIG. 3 , pullarm 30 includes adistal section 31 and aproximal section 33 that are detachable. When thedevice 80 is detached from thespacer 10,proximal section 33 detaches from thedistal section 31. Thespacer 10, including the pull armdistal section 31, remains as thedelivery device 80 andproximal pull arm 33 are removed. Thepull arm 30 may extend through only a portion of thedelivery device 80, or may extend through the entire length. - Pins are positioned within the
spacer 10 to connect together thelinkages 40, pullarm 30, andplates 50. As illustrated inFIG. 1 , pins 60 extend through thelinkages 40 andplate 50.Pin 61 extends through thelinkages 40 andaperture 36 in thepull arm 30 at the distal end of the spacer.Pin 62 extends through thelinkages 40 andslot 37 in thepull arm 30.Pins spacer 10. In one embodiment,pin 62 andpin 86 are constructed from asingle push link 97 as illustrated inFIG. 14 . In one embodiment, each pin has a diameter of about 1.33 mm. The term “pin” used herein is broadly used as a means for pivotally attached two or more members. One skilled in the art will understand that various other similar devices may serve this same function and are considered within the scope of the present invention. - As illustrated in
FIG. 1 , in the closed orientation thespacer 10 has a bullet-like configuration. Theplates 50,linkages 40, and pullarm 30 combine together to form a rounded or angled front which eases the insertion of thespacer 10 in the patient. In one embodiment, the contact surfaces 52 are symmetric about a centerline C, i.e., and have the same orientation relative to the centerline. In one embodiment, the contact surfaces 52 of theplates 50 are parallel with the centerline C when thespacer 10 is in the closed orientation. In one embodiment, thespacer 10 in the closed orientation has a length of between about 22-24 mm, width of about 8 mm, and a height of about 7 mm. - As illustrated in
FIG. 2 , thespacer 10 in the open configuration has a larger height. The height may be adjusted depending upon the angle of thelinkages 40 relative to the centerline C. Thespacer 10 may be expanded to a variety of different sizes and heights and the term “open configuration” is used to indicate any of these orientations. In one embodiment, when thespacer 10 is expanding from the closed orientation, the contact surfaces 52 remain symmetrical about the centerline C. In one embodiment, bothplates 50 move equal amounts such that the distance between the centerline C and the contact surface is the same for eachplate 50. In another embodiment, oneplate 50 moves a greater amount than thecorresponding plate 50. In another embodiment, oneplate 50 is fixed and thecorresponding plate 50 moves outward to increase the height ofspacer 10. - A variety of
different delivery devices 80 may be used for positioning thespacer 10 between the vertebral members. One embodiment is illustrated inFIG. 4 and includes an elongated rod attached to the proximal end of thespacer 10. In one embodiment, the delivery device is hollow and surrounds at least a portion of thepull arm 30.Delivery device 80 may have a variety of cross-sectional shapes and sizes depending upon the application.Delivery device 80 may be constructed of a single elongated member, or may be constructed of different sections such asfirst section 82 andsecond section 84. - In one embodiment, movement of the
second section 84 relative to thefirst section 82 causes thespacer 10 to move between the first and second orientations. In one embodiment, greater relative movement results in a greater spacer height. Anindicator gauge 90 may be positioned along thedelivery device 80 to indicate the height of thespacer 10. In one embodiment as illustrated inFIG. 5 ,first indicia 91 on thefirst section 82 is positioned in proximity tosecond indicia 92 on thesecond section 84. Theindicia spacer 10. Theindicator gauge 90 may be positioned at a variety of locations along the length of thedelivery device 80. In one embodiment, theindicator gauge 90 is located to be positioned on the exterior of the patient to provide for more straight-forward viewing by the surgeon. -
Delivery device 80 may be attached to thespacer 10 in a number of different manners. In one embodiment as illustrated inFIG. 1 ,pin 86 extends through thedevice 80 and theslot 37 within thepull arm 30 to connect thespacer 10 to thedevice 80. In one embodiment, apush link 97 has afirst pin 62 that connects to theproximal linkages second pin 86 that connects to thedelivery device 80. In another embodiment, thedelivery device 80 is permanently attached to thespacer 10. In another embodiment, thepull arm 30 is also thedelivery device 80. - In one embodiment, the
spacer 10 is inserted via thedelivery device 80 between the vertebral members and removed upon completion of the procedure. In one embodiment, thespacer 10 is removed from thedelivery device 80 and remains within the patient. Thespacer 10 may remain permanently within the patient, or in one embodiment, after the spacer is detached and the surgeon completes the procedure, thedelivery device 80 is reattached to remove thespacer 10. In one embodiment,pin 86 is broken to remove thedevice 80 from thespacer 10. In one embodiment as illustrated inFIG. 3 , pullarm 30 includes adistal section 31 and aproximal section 33 that are detachable. When thedevice 80 is detached from thespacer 10,proximal section 33 detaches from thedistal section 31. Thespacer 10, including the pull armdistal section 31, remains as thedevice 80 andproximal pull arm 33 are removed. - In one manner of use,
spacer 10 is connected to the distal end of thedelivery device 80. While in the closed orientation, thespacer 10 is positioned within the patient between adjacent vertebral members. In one embodiment, thespacer 10 is positioned within the disc space between the adjacent vertebral members and contacts the end plates of the vertebral members upon expansion. Once positioned, an axial load or deployment force is applied to thepull arm 30 to force thepull arm 30 inward in the direction ofarrow 89 inFIG. 4 . Axial movement results in thelinkages 40 pivoting outward from the closed position in the embodiment ofFIG. 1 towards the open orientation in the embodiment ofFIG. 2 . Theteeth 44 of opposinglinkages 40 mate together during the movement with theplates 50 moving outward from the centerline C. In one embodiment, each of the twoplates 50 move equal amounts and are symmetric about the centerline C. - As the
linkages 40 expand outward and thepull arm 30 moves inward, pin 62 slides along thedistal arm slot 37 as thespacer 10 moves from the closed to open orientations.Pin 61 is mounted withinlinkages 40 and thepull arm aperture 36 and does not move relative to thepull arm 30. In the closed orientation illustrated inFIG. 1 ,pin 61 is spaced apart from pin 62 a distance greater than in the open orientation as illustrated inFIG. 2 . The amount of axial movement of thepull arm 30 results in the amount of deployment of thespacer 10. Thespacer 10 may he opened to any distance between the closed and open orientations depending upon the specific application. - An axial force is applied to the
pull arm 33 to deploy thespacer 10 to the open position. The power mechanism to apply the force may be within thespacer 10, ordelivery device 80. In one embodiment, the axial force is applied by linearly moving thepull arm 30. In one embodiment,section 84 is attached to theproximal pull arm 33. Thesection 84 can be locked in the extended position away from thefirst section 82 to lock thespacer 10 in the open orientation. In one embodiment, ascroll 77 is threaded onto the distal end of thesecond section 84 adjacent to thefirst section 82 as illustrated inFIG. 4 .Section 84 and scroll 77 apply a force to thepull arm 30 to expand thedistractor 10. Scroll 77 can be threaded distally along thesecond section 84 to contact thefirst section 82 and lock thedistractor 10 in an opened position. To close thedistractor 10, scroll 77 is threaded proximally along thesecond section 84. In one embodiment, scroll 77 is knurled to allow rotation of thescroll 77 by hand. - A mechanism for applying an axial force to the
pull arm 30 may have a variety of configurations. The mechanism may be positioned adjacent to thespacer 10, or positioned distant from thespacer 10 to be outside the patient. In one embodiment illustrated inFIG. 5 , a power mechanism is attached to thedelivery device 80 to apply an axial force. Power mechanism includes aquick release mechanism 72 at the distal end of power mechanism to attach to the delivery devicefirst section 82. In one embodiment,quick release mechanism 72 includes a spring-biasedcollar 73 positioned around areceptacle 74.Collar 73 may be pulled back to load thefirst section 82 within thereceptacle 74. Releasing thecollar 73 causes thereceptacle 74 to contract and lock thefirst section 82. In one embodiment,quick release mechanism 72 includes one or more balls that engage in grooves in thefirst section 82. In one embodiment, aslide lock 75 attaches to thesecond section 84. Torque is applied to ahandle 76 causing thescrod 77 andsecond section 84 to separate from thefirst section 82 thus applying an axial force to thepull arm 30 and opening thedistractor 10. At the desired orientation, scroll 77 is threaded distally to contact thefirst section 82 and lock thedistractor 10. Once locked, the power mechanism 70 can be removed from thedelivery device 80 for more working space for the surgeon. - The
handle 76 is operatively connected to thescroll 77 and rotation causes movement of thespacer 10. In one embodiment as illustrated inFIG. 15 , handle 76 includes aheight indicator gauge 90 to determine the height of thespacer 10. Theheight indicator gauge 90 includesmarkings 121 on thehandle 76 that align with anindicator 130 on thesection 84. Themarkings 121 may be radially positioned along thehandle 76 and move past thestationary indicator 130 during rotation of thehandle 76 to indicate the height of thespacer 10. - In one embodiment, the
indicator 130 is an arrow or similar marking that points towards thehandle 76. The height of thespacer 10 is indicated by the marking 121 that is aligned with theindicator 130.Indicator 130 may also include a window with the spacer height indicated by the marking 121 appearing within the window. - The markings 120 may include a single row of numbers that extend radially around the height gauge 120. The numbers indicate the height of the
spacer 10. By way of example,number 08 indicates thespacer 10 is at a height of about 8 mm, 09 indicates a height of about 9 mm, etc. In one embodiment, themarkings 121 are evenly spaced around the circumference of the height gauge 120. In another embodiment, the space between themarkings 121 increases as the height of thespacer 10 increases. The chart below indicates one embodiment of the angular rotation and height. In this embodiment, thespacer 10 includes a height of about 8 mm when in the dosed orientation. An increase in height to about 9 mm requires an angular rotation of the handle of about 48°. An increase in height from 9 mm to 10 mm requires an additional angular rotation of about 59°. The additional amounts of angular rotations are further illustrated for each height. In this embodiment,spacer 10 includes a maximum height of about 15 mm. -
Height Angular Angular h Rotation Increase (mm) (degrees) (degrees) 8 0 0 9 48 48 10 107 59 11 179 72 12 266 87 13 369 103 14 492 123 15 641 149 - The
markings 121 may be arranged in a single row spaced along the circumference of thehandle 76. In another embodiment as illustrated inFIG. 15 , two or more rows of axially-offsetmarkings 121 extend along thehandle 76. The additional rows may be necessary when the amount of angular rotation exceeds 360°. - In one embodiment,
teeth 129 may be positioned on the edge of thehandle 76. Theteeth 129 contact the edge ofsection 84 during rotation of thehandle 76 to provide tactile feedback to assist in indicating the amount of relative movement and the height of thespacer 10. - The
indicator gauge 90 may be positioned at a variety of locations along thedelivery device 80. In one embodiment,indicator gauge 90 is positioned in proximity to thescroll 77. Themarkings 121 orindicator 130 may be positioned on thescroll 77, with the other positioned on asupport 79 that extends along thesecond section 84. Theindicator gauge 90 may also be positioned between thecollar 73 and thereceptacle 74, or between thereceptacle 74 and thefirst section 82. - A linkage axis L is formed by the line extending through the
linkage 40. In embodiments illustrated inFIGS. 1 and 2 , linkage axis L extends through the points of intersection with theplate 50 and pullarm 30. A link angle α is formed by the linkage axis L and the centerline C. In the embodiment illustrated inFIG. 1 , the link angle α is greater than zero when thespacer 10 is in the dosed orientation. In one embodiment, a link angle α greater than 0° in the dosed orientation has been determined to facilitate opening thespacer 10. - The axial force, or required deployment force, necessary to open the spacer 10 changes during the expansion process. Additionally, the force applied by the
spacer 10 on the vertebral members during the expansion process, or allowable disc space load, changes during the expansion process. Stated in another manner using a 3-coordinate geometry having coordinates x, y, and z, the axial force is the force in the x direction and the vertebral member bad is the force in the y direction. - In one embodiment, the
spacer 10 is positionable between a dosed orientation having a height of about 7 mm and a link angle α of about 16°, and an open configuration having a height of about 14 mm and a link angle α of about 49°. The following chart illustrates the parameters of thespacer 10 at the various stages of deployment: -
Link Link Required Allowable Height Angle Angle Deployment Disc Space h θ θ Force Load (mm) (rads) (degrees) (lbf) (lbf) 7 0.29 16.61 541.15 322.79 7.5 0.33 18.63 535.12 360.76 8 0.36 20.67 528.34 398.74 8.5 0.40 22.75 520.77 436.71 9 0.43 24.85 512.40 474.69 9.5 0.47 27.00 503.17 512.66 10 0.51 29.18 493.04 550.64 10.5 0.55 31.41 481.94 588.61 11 0.59 33.70 469.82 626.59 11.5 0.63 36.05 456.59 664.56 12 0.67 38.47 442.15 702.54 12.5 0.72 40.97 426.38 740.51 13 0.76 43.57 409.11 778.49 13.5 0.81 46.30 390.17 816.46 14 0.86 49.16 369.28 854.44
These calculations are theoretical and based on the yield strength (2% elongation) of a 1.3 mm pin in double shear which is approximately 564.7 lbs. As can be seen, the required deployment force decreases as the link angle α increases, and the allowable vertebral member load increases as the link angle α increases. -
FIGS. 6 and 7 illustrate another embodiment of thespacer 10.FIG. 6 illustrates thespacer 10 in a closed orientation. The overall shape of thespacer 10 is cylindrical and includes anose 34 having a rounded front to ease insertion into the patient. Thespacer 10 includeslinkages 40, a pair ofplates 50, and apull arm 30 including thenose 34. Aproximal section 39 forms part of thespacer 10. In one embodiment,plates 50 have a length less than the overall spacer length.Linkages 40 includeteeth 44 at each end, and a pair ofapertures 42 for receiving pins 62.Nose 34 andproximal section 39 includerecesses 31 in which thelinkages 40 are positioned. In one embodiment,linkages 40 andplates 50 have a rounded surface to conform to the cylindrical shape. In another embodiment,linkages 40 andplates 50 have a flat exterior surface. In the closed orientation, the link angle α is 0°. -
FIG. 7 illustrates thespacer 10 in the opened orientation.Teeth 44 of opposinglinkages 40 mate together as thespacer 10 opens.Nose 34 is connected to apull arm 30. An axial force applied to thepull arm 30 forces thenose 34 inward towards thedelivery device 80. The movement of thenose 34 causes thelinkages 40 to move resulting inplates 50 moving outward from the centerline C of thespacer 10. Thepull arm 30 may be axially moved a variety of distances to control the height of thespacer 10. - In embodiments illustrated in
FIGS. 6 and 7 ,linkages 40 do not connect directly to thepull arm 30.Linkages 40 connect to thenose 34 which is connected to thepull arm 30. Movement of thenose 34 causes movement of thelinkages 40. Theproximal linkages 40 may or may not be directly or indirectly connected to thepull arm 30. In one embodiment,proximal linkages 40 are directly connected to the pull arm through pins. - In one embodiment, the
linkages 40 connect to a middle section of theplates 50 adjacent to a mid-point M of the length. In another embodiment,linkages 40 connect to theplates 50 towards the ends distanced away from the mid-point M. In another embodiment, twolinkages 40 connect at different positions along theplates 50 relative to the mid-point M (i.e.,linkages 40 are not evenly spaced from the mid-point M). By way of example, afirst linkage 40 connects at a position near the distal end of the plate 50 a distance x from the mid-point M, and asecond linkage 40 connects adjacent to the mid-point of theplate 50 at a distance x less y from the mid-point. Theplates 50 may be parallel to the centerline C, or angled in either direction relative to the centerline C. -
FIGS. 8 , 9, and 10 illustrate another embodiment havingfirst linkages 140 with a different length thansecond linkages 240. First andsecond linkages pull arm 130 andplate 150.Pin 161 attaches a first end of thefirst linkages 140 to thepull arm 130, and pin 162 attaches a first end of thesecond linkages 240 to thepull arm 130.Pins 160 connect the second ends of thelinkages plates 150.Teeth 144 at the second ends of thelinkages spacer 110 moves between open and closed orientations. -
Plates 150 each have curved contact surfaces 152. In one embodiment, the curvature has a radius of about 100 mm to fit the concave shape of the endplates of the vertebral members. Adistal end 189 of thepull arm 130 has an angled configuration that compliments the curvature of theplates 150. The combination of thedistal end 189 andcurved plates 150 give the spacer 110 a bullet shape in the closed orientation as illustrated inFIG. 8 . In one embodiment, thespacer 110 has a length of about 30 mm, and a width of about 27 mm. - Varying the ratios of the link lengths controls the amount of lordotic angle θ formed by the
plates 150 during deployment. The greater the differences in lengths, the greater the lordotic angle as thespacer 110 is deployed. In one embodiment, the length of thedistal linkages 140 is about 7.4 mm, and the length of theproximal linkages 240 is about 12 mm. The height of thespacer 110 also increases with the deployment. The height is measured from the peak of curvature of theplates 150.FIGS. 8 , 9, and 10 illustrate the changes in height and lordotic angle θ during deployment of thespacer 110. -
FIG. 8 illustrates thespacer 110 in the closed orientation. In one embodiment, the height is about 8.4 mm. In the closed orientation, the lordotic angle is about 0° with theplates 150 being substantially parallel. -
FIG. 9 illustrates a partial deployment of thespacer 110. Thepull arm 130 has been moved proximally inward (i.e., to the right as illustrated inFIG. 9 ) thus pullingpin 161 inward and causingpin 162 to slide along the slot 37 (not illustrated) centered on the centerline C. In this embodiment, the height is about 13.8 mm, and the lordotic angle θ is between about 8.4°-8.6°. -
FIG. 10 illustrates thespacer 110 in a fully-deployed orientation. The pull arm 132 and pin 161 have been moved further in the proximal direction.Pin 162 has continued to slide towards a distal section ofslot 37.Plates 150 have continued to move outward with the lordotic angle θ increasing to about 15°-15.3°, and the height about 16.8 mm. -
FIGS. 11 , 12, and 13 schematically illustrate the movement of thelinkages spacer 110 moves between closed and open orientations.FIG. 11 schematically illustrates thespacer 110 in the closed orientation (as shown inFIG. 8 ). As illustrated inFIG. 11 ,line 201 extends between a mid-point of thepins 160 that connect theupper plate 150 to thelinkages line 201.Line 202 extends between a mid-point ofpin 161 and a mid-point ofpin 160 that connects thedistal linkage 140 to theupper plate 150.Line 203 extends between a mid-point ofpin 162 and the mid-point ofpin 160 that connects theproximal linkage 240 to theupper plate 150. A first angle A is formed between theline 202 and line P. A second angle B is formed between theline 203 and line P. In the closed orientation, line P is perpendicular to the centerline C, and the lordotic angle is 0°. In one embodiment, thedistal linkages 140 are about 7.4 mm, theproximal linkages 240 are about 12 mm, and the distance between thepins 160 is about 3.75 mm. - In an embodiment with the
distal linkages 140 shorter than theproximal linkages 240, a difference exists between larger angle B and smaller angle A. The formula explaining the angles is defined as: -
Angle B=Angle A+Difference (Eq 1) - In one embodiment with
distal linkage 140 being about 7.4 mm and theproximal linkages 240 about 12 mm, the angle A is about 73.2°, angle B is about 79.6°, and the difference is about 6.4°. -
FIG. 12 schematically illustrates thespacer 110 in a partially-deployed orientation (as shown inFIG. 9 ). The orientation ofline 201 has changed as the relative distance changes betweenpins line 201 also changes accordingly. Angle A formed betweenline 202 and line P has decreased, and angle B formed betweenline 203 and line P has also decreased. However, the difference between the two angles has remained the same andEquation 1 remains true. This is caused because thelinkages plate 150. In the specific embodiment, angle A is about 49.7°, Angle B is about 56.3°, and the difference is about 6.4°. -
FIG. 13 schematically illustrates thespacer 110 in the open orientation (as shown inFIG. 10 ).Pins - In one embodiment, the angles formed on a lower section of the
spacer 110 also follow the parameters ofEquation 1. In an embodiment with longerdistal linkages 140 thanproximal linkages 240, angle A is greater than angle B by the constant difference. - In the embodiments illustrated, the lordotic angle was about 0° when the
spacer 110 is in the closed orientation. The lordotic angle may be an amount other than 0° in the dosed orientation. Also, the embodiments illustrated include thefirst linkages 140 towards the distal end of thespacer 110 having a smaller length. In other embodiments, thefirst linkages 140 have a greater length than the proximalsecond linkages 240. - In one embodiment, the lordotic angle is determined by the edges of the
plates line 201 and the centerline C. Embodiments are also contemplated in which thespacer 110 includes only a single moving plate. In these embodiments, the lordotic angle is the angled formed byline 201 and the centerline C. -
FIG. 14 illustrates an alternative embodiment of thepins push link 97 is positioned within theslot 37 of thepull arm 30. Thepush link 97 includespins linkages 40 anddelivery device 80 respectively. Pushlink 97 is sized to slide within theslot 37 during movement of thepull arm 30. In one embodiment, push link 97 has an “H” shape with a first set of pins (62, 86) extending on a first side of the device to connect thedelivery device 80 and the first set of proximal links, with a second set of pins extending on a second side to connect the delivery device and the second set of proximal links. - In another embodiment (not illustrated),
pin 62 does not extend through thepull arm 30. A first pin on a first lateral side of thepull arm 30 attaches together two of the proximal linkages, and a second pin on a second lateral side of thepull arm 30 attaches together the other two proximal linkages. In this embodiment, the two pins may be connected to thedelivery device 80. - The term vertebral member is used generally to describe the vertebral geometry comprising the vertebral body, pedicles, lamina, and processes. The
spacer 10 may be sized and shaped, and have adequate strength requirements to be used within the different regions of the vertebra including the cervical, thoracic, and lumbar regions. In one embodiment,spacer 10 is positioned within the disc space between adjacent vertebra.Plates 50 contact the end plates of the vertebra to space the vertebra as necessary. In one embodiment, thespacer 10 is inserted posteriorly in the patient. In another embodiment, thespacer 10 is inserted from an anteriorly into the patient. In another embodiment, the spacer is inserted laterally into the patient. - In another embodiment (not illustrated),
spacer 10 includes only one movingplate 50. A first plate is attached to thelinkages 40 and moves as discussed above. A second plate is stationary. Thelinkages 40 move outward from the stationary plate to expand the height of thespacer 10 to the open orientation. This embodiment may include any number oflinkages 40 depending upon the desired spacing and strength requirements. - The present invention may be carried out in other specific ways than those herein set forth without departing from the scope and essential characteristics of the invention. In one embodiment,
spacer 10 anddelivery device 80 are constructed of stainless steel. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive, and all changes coming within the meaning and equivalency range of the appended claims are intended to be embraced therein.
Claims (7)
1-20. (canceled)
21. A method of spacing vertebral members comprising the steps of:
inserting a spacer in a first orientation with a first height and a first angle between the vertebral members;
applying an axial force to a pull arm and moving an indicator gauge from a first position to a second position; and
pivoting linkages attached to the pull arm and increasing the spacer to a second height larger than the first height, and a second angle greater than the first angle.
22. The method of claim 21 , wherein the step of pivoting the linkages comprises moving the linkages from a first link angle to a second larger link angle.
23. The method of claim 22 , wherein the step of pivoting the linkages causes a plate to move outward from a centerline of the spacer to increase the spacer from the first height to the second height and from the first angle to the second angle.
24. The method of claim 21 , wherein the step of applying the axial force to the pull arm comprises rotating a handle operatively connected to the pull arm.
25. A method of spacing vertebral members comprising the steps of:
orienting a spacer in a first orientation with a first marking on a handle aligned with an indicator;
inserting a spacer in the first orientation between the vertebral members, the spacer having a first height;
rotating the handle and aligning a second marking on the handle with the indicator and causing linkages operatively attached to the handle to move thereby increasing the spacer to a second height larger than the first height.
26. The method of claim 25 , wherein the step of rotating the handle and aligning the second marking on the handle with the indicator further causes the spacer to form a second angular position that is different than a first angular position when the spacer is in the first orientation.
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