CA2232723A1 - Spinal implant - Google Patents
Spinal implant Download PDFInfo
- Publication number
- CA2232723A1 CA2232723A1 CA002232723A CA2232723A CA2232723A1 CA 2232723 A1 CA2232723 A1 CA 2232723A1 CA 002232723 A CA002232723 A CA 002232723A CA 2232723 A CA2232723 A CA 2232723A CA 2232723 A1 CA2232723 A1 CA 2232723A1
- Authority
- CA
- Canada
- Prior art keywords
- pillars
- microns
- spinal implant
- thread
- implant according
- 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
Links
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
- 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
- A61F2/446—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 elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
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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
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
-
- 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
- A61F2/30767—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
-
- 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
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
-
- 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
- A61F2/28—Bones
- A61F2002/2817—Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
- A61F2/28—Bones
- A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
- A61F2002/3011—Cross-sections or two-dimensional shapes
- A61F2002/30112—Rounded shapes, e.g. with rounded corners
- A61F2002/30125—Rounded shapes, e.g. with rounded corners elliptical or oval
- A61F2002/30126—Rounded shapes, e.g. with rounded corners elliptical or oval oval-O-shaped
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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
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
- A61F2002/3011—Cross-sections or two-dimensional shapes
- A61F2002/30138—Convex polygonal shapes
- A61F2002/30153—Convex polygonal shapes rectangular
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
- A61F2002/3011—Cross-sections or two-dimensional shapes
- A61F2002/30138—Convex polygonal shapes
- A61F2002/30154—Convex polygonal shapes square
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
- A61F2002/30199—Three-dimensional shapes
- A61F2002/30224—Three-dimensional shapes cylindrical
- A61F2002/30228—Cylinders of elliptical or oval basis
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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
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
- A61F2002/30199—Three-dimensional shapes
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- A61F2002/30235—Three-dimensional shapes cylindrical tubular, e.g. sleeves
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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
- 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
- A61F2002/30593—Special structural features of bone or joint prostheses not otherwise provided for hollow
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
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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
- A61F2/02—Prostheses implantable into the body
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- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
-
- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
- A61F2310/00796—Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S606/00—Surgery
- Y10S606/907—Composed of particular material or coated
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S606/00—Surgery
- Y10S606/907—Composed of particular material or coated
- Y10S606/909—Bone
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
A spinal implant including a hollow, generally tubular shell having an exterior lateral surface, a leading end, and a trailing end. The shell has a helical thread projecting from its exterior surface. The thread includes a plurality of pillars. Each pillar has a height of 100-4500 microns and a lateral dimension at the widest point of 100-4500 microns. The exterior surface has a plurality of holes therethrough to permit bone growth therethrough. The spinal implant may alternatively have a plurality of pillars projecting from its exterior surface in a regular, non-helical array.
Description
l SPINAL IMPLANT
This invention relates generally to surgical devices for 6 stabilizing the spine, and more particularly to a spinal implant 7 ior use in fusing and stabilizing adjoining spinal vertebrae.
:LO
1l Chronic back problems cause pain and disability for a large 12 segment of the population. In many cases, the chronic back 13 problems are attributed to relative movement between vertebrae 14 in the spine. Spinal surgery includes procedures to stabilize adjacent vertebrae. Common sta~bilization techniques include 16 fusing the vertebrae together.
17 Fusion techniques include removing disc material which 18 separates the vertebrae and impacting bone into the disc area.
19 The impacted bone fuses with the bone material of the vertebrae to thereby fuse the two vertebrae together. In a further advance 21 in the art, spinal implants have been developed to increase the 22 probability of a successful fusion. An example of such a spinal 23 implant is shown in U.S. Pat. No. 5,489,308, which shows a 24 threaded spinal implant which includes a hol]ow cylinder into which bone chips or bone slurry may be placed. The cylinder has 26 holes extending radially therethrough. The bone material grows 27 through the holes to fuse with the bone material of the 28 ~ertebrae. Similar threaded spinal implants are disclosed in 29 V.S. Pat. Nos. 5,489,307; 5,263,'353; 5,458,638; and 5,026,373;
the disclosures of all of the foregoing patents are incorporated 3l herein by reference.
32 The metallic surfaces of these spinal implants, other than 33 the threaded structure with large pores, is essentially smooth 34 without pillars, micropillars or surface texturing. Without such surface texturing the spinal implants in some circumstances may l not mechanically anchor at an early date or affix into the 2 adjoining bone as much as is desi~-able, and may not effectively 3 minimize fibrous capsule formation around the implant. There is 4 a need for a spinal implant with pillars~ micropillars, fins or surface texturing which addresses these problems and provides 6 improvements in these areas; the present invention is such an 7 implant.
9 SUMMARY OF THE. INVENTION
:LO
Ll A spinal implant comprising a hollow, generally tubular L2 shell having an exterior lateral surface, a first end and a 13 second end. The shell has a heli_al thread projecting from its 14 exterior surface, the thread comprising a plurality of pillars.
Each pillar has a height of l00-4500 microns and a lateral 16 dimension at the widest point of 100-4500 microns. The exterior 17 surface has a plurality of holes therethrough to permit bone 18 qrowth therethrough. Alternatively, a plurality of pillars may 19 project from the exterior surface of the shell in a regular, non-helical array.
24 FIG. l is a side elevational view of a spinal implant according to the invention.
26 FIG. 2 is a cross-sectional view taken along line 2-2 of 27 Fig. l.
28 FIG. 3 is a plan view of a portion of the outer surface of 29 the implant of Fig. l.
FIG. 4 is a cross-sectional view taken along line 4-4 of 31 Fig. 3.
32 FIG. 5 is a plan view of an alternative embodiment of the 33 surface of Fig. 3.
34 FIG. 6 is a cross-sectional view taken along line 6-6 of Fig. 5-1 FIG. 7 is a cross-sectional view similar to Fig. 6 showing 2 an alternative embodiment.
3 FIG. 8 is a cross-sectional view similar to Fig. 7 showing 4 an alternative embodiment.
FIG. 8A is a cross-sectional view similar to Fig. 4 showing 6 an alternative embodiment.
7 FIG. 9 is a cross-sectional view similar to Fig. 8 showing 8 an alternative embodiment.
9 FIG. 10 is a cross-sectional view similar to Fig. 7 showing an alternative embodiment.
ll FIG. 11 is a cross-sectional view similar to Fig. 10 showing 12 an alternative embodiment.
13 FIG. llA is a plan view simi]ar to Fig. 5 with the top half 14 of each pillar removed showing an alternative embodiment.
FIG. 12 is a plan view similar to Fig. 5 showing an 16 alternative embodiment.
17 FIG. 13 is a plan view similar to Fig. 12 showing an 18 alternative embodiment.
19 FIG. 14 is a plan view similar to Fig. 13 showing an alternative embodiment.
21 FIG. 15 is a plan view similar to Fig. 13 showing an 22 alternative embodiment.
23 FIG. 16 is a plan view similar to Fig. 15 showing an 24 alternative embodiment.
FIG. 17 is a plan view similar to Figs. 5 and 12 showing an 26 alternative embodiment.
27 FIG. 18 is a plan view similar to Fig. 17 showing an 28 alternative embodiment.
29 FIG. 19 is a plan view similar to Fig. 18 showing an alternative embodiment.
31 FIG. 20 is a plan view similar to Fig. 17 showing an 32 alternative embodiment.
33 FIG. 21 is a plan view similar to Fig. 20 showing an 34 alternative embodiment.
FIG. 22 is a plan view of an alternative embodiment of a CA 02232723 l998-03-l9 1 pillar or fin.
2 FlG. 23 is a cross-sectional view of an alternative 3 embodiment of the implant of Fig. 1.
4 FIG. 24 is a cross-sectional view of an alternative embodiment of the implant of Fig. 1.
]O Generally, the same number is used to identify the same ]1 element which appears in different Figures. With reference to ]2 F'igs. 1-2, there is shown a spinaL implant 10 of a conventional ]3 material such as titanium or other metal or metal alloy having 14 t:hreads or thread segments 12; the spinal implant 10 preferably 'L5 has only one thread which spirals helically around the implant :L6 approximately eight times, a single spiral or helical thread at :L7 t:welve threads per inch being known in the art. Thread 12 :L8 spirals helically around the implant 10 in the conventional :L9 manner, less preferably a plurality of intertwined helical threads may be provided. Space, or valleys 15 are provided ;71 between the threads; preferably, as known in the art, there is 22 only a single valley 15 which spirals helically around the 23 implant approximately eight times and which is defined by the 24 turns of the helical thread. Less preferably the valley 15 can :25 be flat across instead of trough-shaped, so that there is no dip, 26 so that a flat surface joins the base surface 32 of one thread 27 with the base surface 32 of the adjacent thread. A terminal :28 portion 14 of the thread is shown at one end of the implant. The ~9 implant 10 includes a hollow, generally tubular, preferably generally cylindrical shell as shown in Figs. 1-2 and has an 31 exterior lateral surface having a helical thread 12 projecting 32 therefrom as shown in Fig. 1. The cross-section of the 33 cylindrical shell of the implant 10 is preferably circular as 34 known in the art; less preferably it is oval as shown in Fig. 23, :Less preferably rectangular or rectangular with rounded ends as 1 shown in Fig. 24 (like a squashed oval). The implant 10 has a 2 leading or first end 7 and a trailing or second end 8; the 3 helical nature of thread 12 permits thread 12 to engage vertebra 4 material as the implant is screwed in (with leading end 7 leading the way) and draw the implant into the spine. The implant has 6 a longitudinal axis down the ce~ter of the cylinder and the 7 thread 12 is helically oriented around this axis.
8 As known in the art, a spinal implant is generally a hollow 9 threaded cylinder made of a titanium alloy, about 12-18 mm in L0 diameter and 20-28 mm in length. Polyethylene or plastic caps L1 may be used on the ends of the implant to maintain the cage 12 material inside. Inside the cylindrical spinal implant lO is a L3 first interior chamber lG, a second interior chamber 18, and 14 reinforcing ribs 20, 24, 26. I~oles 22 are provided radially through the side surface of the implant to permit bone growth 16 therethrough. Larger holes than those shown in Fig. 1 may also 17 be provided, as is known in the arlt (see U.S. Pat. No. 5,489,307, 18 incorporated herein by reference). The threads 12 comprise a 19 plurality of pillars or micropillars 6. Preferably the entirety of thread 12 or all the turns of thread 12 comprises pillars, 21 less preferably at least 75%, 50%, or 25% of thread 12 comprises 22 pillars. Pillars as used in the claims herein includes 23 cylindrical pillars, square pillars, rectangular pillars, and 24 crescent-shaped pillars.
With reference to Figs. 3-4, there is shown a detail of the 26 surface of the implant 10 showing pillars 6 extending from base 27 surface 32 of the thread 12, the threads being separated by 28 valleys 15. Each pillar 6 in Figs. 3-4 is essentially an 29 inverted truncated cone, each piLlar 6 having a truncated cone side surface 28 and a round top face 30. As shown in Fig. 4, the 31 side surface 28 of pillar 6 is undercut, having an undercut angle 32 A-A which is preferably 10~-20~.
33 With reference to Figs. 5-6, there is shown an alternative 34 embodiment comprising square four-sided truncated pyramidal pillars 34 extending from base surface 32 between valleys 15, 1 each pillar 34 being undercut by an angle C-C of preferably 10~-2 20~ on all four faces to yield side surface face 3~, the pillar 3 having a square top face 38. The base surface 32 is typically 4 about 900 microns wide.
With reference to Fig. 7, there is shown an alternative 6 embodiment wherein pillars 46, which may be cylindrical or square 7 as described above, extend from base surface 40, have a top face 8 44 and are undercut as described above yielding side surface 42.
9 With reference to Fig. 8, there is shown an alternative embodiment similar to Fig. 7, but wherein each pillar in Fig. 7 11 is replaced by a pair of pillars in Fig. 8; pillars 48, 50 12 extending from base surface 56 are the same and are side by side 13 (alternatively they are staggered), each pillar being square or 14 circular in top view, having a top face 54 and being undercut as described above to yield side sur-face 52. As shown in Fig. 8, 16 the pair of pillars 48, S0 define a line which is laterally 17 oriented with respect to the direction of the thread, that is, 18 the helical line defined by the helical thread.
19 Fig. 9 is an alternative embodiment similar to Fig. 8, wherein pillars 58, 60, which are circular or square in top view 21 and are the same and are side by side, extend from base surface 22 62, have a top surface 6~, and are undercut as described above 23 to yield a side surface 64.
24 Fig. 10 shows an alternative embodiment identical to Fig.
7, except that a pillar 70 is placed in each valley adjacent each 2~ pillar 68; each pillar 70 having the same dimensions as pillar 27 48. Fig. 11 shows an alternative embodiment similar to Fig. 10, 28 wherein pillars 72 are the same as pillars 70, but the threads 29 74, 76 are solid without pillars, thus having the appearance of a conventional thread, and having a sloping side surface having 31 an angle of about 5~, less preferably 1~-10~, as shown at K-K.
32 Fig. 12 is a plan view similar to Fig. 5 showing an 33 alternative embodiment wherein regularly-arrayed pillars or fins 34 78 are rectangular in top view and extend from base surface 79 to form threads which are separated by valleys 15.
CA 02232723 l998-03-l9 1 Alternatively, every other pillar 78 can be rotated 90~ so it is 2 oriented laterally rather than longitudinally. ~ig. 13 is an 3 alternative embodiment similar to Fig. 12, except that regularly-4 arrayed rectangular pillars 80 extending from base surface 81 are oriented laterally rather than longitudinally. Fig. 14 is an 6 alternative embodiment similar to Fig. 13, except that each 7 pillar 82 extending from base surface 83 is staggered between the 8 pillars in the adjacent threads, rather than being directly 9 across from the pillars in the adjacent threads.
~ig. 15 shows an alternative embodiment similar to Fig. 13, ]1 wherein each pillar 84a, 84b, and 84c extending from base surface 12 85 is angled with respect to the longitudinal axis of the thread ].3 on which it is placed, the angle being preferably 45~, less 'L4 preferably 30~-60~, angled having the conventional meaning of :L5 other than 0~, 90~ and 180~. As helical thread 12 progresses :L6 helically around implant 10, it travels 360~ each time or turn :L7 around the implant. As shown in Fig. 15, every 360~ or one turn :L8 around the implant, the angle of the pillars is rotated 90~ as :L9 shown in Fig. 15 so that the angle of the pillars alternates in ;'0 adjacent threads to yield a herringbone arrangement as shown in 21 Fig. 15. Holes 71a, 71b are provided in valleys 15a, 15c to ;72 permit bone chip placement or deposit therethrough as described 23 below, and subsequent bone growth therethrough. Since the ;74 implant is screwed into position in the spine of the patient, ;'5 each fin or pillar acts like a tiny snowplow blade pushing snow ;'6 to the side of the street; that is, as the implant is screwed in, 27 each fin shaves additional bone from the adjacent bony tissue and ;'8 pushed it in a certain direction. If the implant segment shown 29 in Fig. 15 is raked downwardly (corresponding to the implant :30 being screwed in), fins 84a will shave off bone chips or :31 fragments and push them toward holes 71a; fins 84b will shave off :32 bone fragments and push them in the opposite direction toward :33 holes 71b; fins 84c will shave off bone fragments and also push :34 them toward holes 7lb. Thus the holes are placed in every other :35 valley, not every valley, the holes being placed in the valleys 1 where the bone fragments are being pushed. Note valleys 15b and 2 15d do not have holes and the alternate valleys 15a and 15c do 3 have holes. The fins may be tilted toward the holes or undercut 4 more severely or with a concave surface on the side or portion facing the holes to assist in pushing the bone fragments down 6 toward the holes. In this way additional bony material is driven 7 down into the holes and into the implant as it is screwed in, or 8 at least driven toward or adjacent the holes to facilitate bone 9 growth through the holes. These concepts are further illustrated by Fig. 22, where a scalloped or crescent-shaped pillar or fin ll 100 having ends 101 and 102 is shown in top view. These fins 100 12 can be substituted for the fins in Fig. 15 and oriented on an 13 angle so as to scrape or shave off bone fragments and direct or ~4 push them towards the holes 7la, 7lb. The ends 101, 102 can alternatively be flat, have a blunt point, or have a small or 16 large radius of curvature. To be more effective, these fins for 17 scraping may be spaced further apart and placed in particular at 18 the leading end 7 of the implant 10. With regard to the l9 herringbone arrangement in Fig. 15, alternatively the angle of the pillars may be kept constant all over the implant and not 21 rotated periodically to form the herringbone arrangement. The 22 pillars can be staggered or un-,taggered with respect to the 23 pillars in adjacent threads. Alternatively the holes may be 24 placed in all the valleys or staggered or eliminated.
Fig. 16 shows an alternative embodiment similar to Fig. 15, 26 except that each pillar 86 extending from base surface 87 is 27 rotated 90~ from the orientation of the immediately preceding 28 pillar in the thread. The pillars 86 can be staggered or un-29 staggered with respect to the pillars in adjacent threads.
Any combinations of any of the arrangements described herein 31 can also be provided.
32 The pillars preferably or alternatively have a top face 33 which is somewhat rounded instead of flat and without sharp edges 34 which may have a potential for tissue necrosis. This can be 3S achieved by sandblasting the pillars after fabrication or 1 treating them chemically to take the edges off. This embodiment 2 is illustrated in Fig. 8A, which is the same as Fig. 4, except 3 that each pillar 6a has a top face 30a which is somewhat rounded 4 and the sharp edge where top face 30a meets side surface 28a has been removed, these changes being achieved by sandblasting or 6 chemical treatment. This feature is further illustrated in Fig.
7 llA, which is the same as Fig. 5, except that the top half of 8 each pillar 34 has been removed to show cutaway top surface 38a 9 and to illustrate that each of t:he four side edges 39 of the pillar 34 has been rounded (such as replaced by a radius of 11 curvature) and the sharp edge removed such as by sandblasting or 12 chemical treatment. Furthermore a radius of curvature or fillet 13 can be provided at or around the base of each pillar where it 14 joins or attaches to the surface.
In the Figures, dimension B-B in Fig. 4 is preferably 1000 16 microns and the following dimensions are preferably the following 17 lengths: D-D -- 1000 microns; E-E -- 500 microns; G-G -- 500 18 microns; J-J -- 500 microns. He:ight is measured from the base 19 surface to the top face, width is~measured at the top face (width of a circle being the diameter), and the edge-to-edge distance 21 is measured at the top face. In Fig. 8 the edge-to-edge distance 22 F-F is preferably 500 microns and in Fig. 9 the edge-to-edge 23 distance H-H is preferably 250 microns. In Figs. 3-6, the 24 pillars are preferably 1000 microns in width; in Fig. 7 the pillars are 500 microns in width, and in Figs. 8-9 the individual 26 pillars are 2S0 microns in width. The angles A-A and C-C are 27 preferably 10~-20~, less preferably 5~-30~. Less preferably 28 these angles may be 0~. Alternatively, the pillars may be wider 29 at the bottom than at the top, so that the side surfaces slope outward as they get closer to the base, by an amount such as 1~-31 30~, more preferably 1~-10~, more preferably 1~-5~. The valleys 32 lS are typically 250-3000, more preferably 500-2000, more 33 preferably about 1000, microns wi.de.
34 The pillars on the external surface of the spinal implant will help to more effectively mechanically anchor the implant at CA 02232723 l998-03-l9 l an early date and affix the implant into the adjoining bone and 2 more effectively reduce, minimize or disrupt fibrous capsule 3 formation around the implant.
4 The pillars of the implant are preferably inverted truncated cones or pyramids as illustrated, preferably with the above 6 dimensions. In Figs. 12-16, the pillars or fins have a 7 rectangular top face having a width of 100-1000, more preferably 8 200-950, more preferably 300-900, more preferably 400-825, more 9 preferably 500-750, less preferably about 250, less preferably ]L0 200-250, less preferably 150-300, microns and a length of 400-]Ll 4500, more preferably 500-3000, more preferably 600-2000, more ;L2 preferably 700-1750, more preferably 1000-1500, microns (the :L3 length being greater than the width and preferably being 2-lo, :L4 more preferably 2-6, more preferably 2-4, times the width);
:L5 otherwise these pillars are dimensionally the same as the pillars :L6 described above.
:L7 Less preferably the dimensions or distances of the pillars :L8 mentioned herein can be within a range +5~, less preferably +10%, :L9 less preferably +20%, less preferably +30~, less preferably +40%, less preferably +50%.
:71 The height of the pillars is preferably 100-4500 microns, ;~2 more preferably 100-2500 microns, more preferably 150-2000 23 microns, more preferably 200-1500 microns, more preferably 400-~4 1200 microns, more preferably 500-1000 microns, alternatively about 500 or 1000 microns. The width of the pillars is ;'6 preferably 100-4500, more preferably 100-3000, more preferably ;27 150-2000, more preferably 200-1500, more preferably 250-1000, ;28 microns. Where a pair of pillars is on the same thread as in 29 Fig. 8, the edge-to-edge distance is preferably 100-3000, more preferably 100-2000, more preferclbly 130-1000, more preferably 31 160-800, more preferably 200-600, more preferably 250-500, 32 microns. The lateral dimension at the widest point of each 33 pillar (for circular and square pillars the width and for 34 rectangular pillars the length) is preferably 100-4500, more preferably 150-2500, more preferably 200-1500, microns.
CA 02232723 l998-03-l9 1 Two adjacent pillars in the same thread (ie, without 2 crossing a valley) such as in Figs. 1, 18 and 19 have an edge-to-3 edge distance preferably the same as the width of the pillar or 4 alternatively 100-4500, more preferably 100-2000, more preferably 250-1000, microns or 250, 500 o.r 1000 microns. For fins or 6 rectangular pillars such as in Figs. 12-16, the edge-to-edge 7 distance is preferably about the width of the pillar, or loO-8 4500, more preferably 100-2500, more pre~erably 250-1000, 9 microns, or as shown in Figs. 12-lG, or 250, 500, or loOo microns.
11 Less preferably pillars such as those described above can 12 be placed on the interior surface of the implant (to help hold 13 the bone in place), but preferably without undercutting.
14 The metal surfaces of the implant can optionally be coated with hydroxy appetite, bone morphogenic protein, or other bone 16 inductive agents.
17 Conventional spinal implants are provided with large holes, 18 such as at 22 in Figs. 1-2, for bone growth therethrough. The 19 present invention also provides a plurality of smaller, more effective holes for bone growth therethrough. Fig. 17 is an 21 alternative embodiment similar to Figs. 5 and 12 showing valleys 22 15, pillars 88 extending from the base surface 32, and holes 90 23 provided between the pillars 88. Fig. 18 is an alternative 24 embodiment similar to Fig. 17 showing pillars 91 in the threads and holes 92 in the valleys 15...... Fig. 19 is an alternative 26 embodiment similar to Fig. 18 showing pillars 93 in the threads 27 and fin holes or rectangular holes 94 in the valleys 15. Fig.
28 20 is an alternative embodiment wherein the cylindrical surface 29 of the spinal implant 10 has a smooth unthreaded surface 95 from which the pillars 96, which are regularly-arrayed and non-31 helical, directly emerge, and has holes 97 between the pillars 32 96. Fig. 21 is an alternative embodiment similar to Fig. 20, 33 also having a smooth unthreaded surface 89 from which fins or 34 rectangular pillars 98, which are arrayed in a non-helical herringbone arrangement or herringbone type pattern, directly CA 02232723 l998-03-l9 1 emerge, interspersed with holes 95~.
2 With reference to Figs. 17-21, the pillars may be any of the 3 pillars described herein. The round holes go through the wall of 4 the implant into the interior chamber and are preferably 150-1500, more preferably 200-1250, more preferably 250-1000, 6 alternatively 375-750, alternative]y 450-575, alternatively about 7 500, microns in diameter, with 250, 500, and 1000 microns being 8 typical hole diameters. The rectangular holes 94 have the same 9 width and length dimensions as the width and length dimensions of the pillars or fins in Figs. 12--16. Rectangular holes may be 11 substituted for round holes and vice versa. I~ectanyular holes 12 may be oriented longitudinally or laterally or at an angle or a 13 combination thereof, such as alternating longitudinal and 14 lateral, or oriented as the fins in Figs. 12-16 are oriented.
The holes may be staggered or unstaggered with respect to each 16 other and with respect to the pillars. The pillars may be 17 staggered or unstaggered with respect to each other and with 18 respect to the holes. Any of the foregoing arrangements may be 19 combined on the same implant, sucl-l as the holes in Figs. 17 and 18 being placed into the same imp]ant.
21 Although the preferred embodiments of the invention have 22 been shown and described, it should be understood that various 23 modifications may be resorted to without departing from the scope 24 of the invention as disclosed and claimed herein.
This invention relates generally to surgical devices for 6 stabilizing the spine, and more particularly to a spinal implant 7 ior use in fusing and stabilizing adjoining spinal vertebrae.
:LO
1l Chronic back problems cause pain and disability for a large 12 segment of the population. In many cases, the chronic back 13 problems are attributed to relative movement between vertebrae 14 in the spine. Spinal surgery includes procedures to stabilize adjacent vertebrae. Common sta~bilization techniques include 16 fusing the vertebrae together.
17 Fusion techniques include removing disc material which 18 separates the vertebrae and impacting bone into the disc area.
19 The impacted bone fuses with the bone material of the vertebrae to thereby fuse the two vertebrae together. In a further advance 21 in the art, spinal implants have been developed to increase the 22 probability of a successful fusion. An example of such a spinal 23 implant is shown in U.S. Pat. No. 5,489,308, which shows a 24 threaded spinal implant which includes a hol]ow cylinder into which bone chips or bone slurry may be placed. The cylinder has 26 holes extending radially therethrough. The bone material grows 27 through the holes to fuse with the bone material of the 28 ~ertebrae. Similar threaded spinal implants are disclosed in 29 V.S. Pat. Nos. 5,489,307; 5,263,'353; 5,458,638; and 5,026,373;
the disclosures of all of the foregoing patents are incorporated 3l herein by reference.
32 The metallic surfaces of these spinal implants, other than 33 the threaded structure with large pores, is essentially smooth 34 without pillars, micropillars or surface texturing. Without such surface texturing the spinal implants in some circumstances may l not mechanically anchor at an early date or affix into the 2 adjoining bone as much as is desi~-able, and may not effectively 3 minimize fibrous capsule formation around the implant. There is 4 a need for a spinal implant with pillars~ micropillars, fins or surface texturing which addresses these problems and provides 6 improvements in these areas; the present invention is such an 7 implant.
9 SUMMARY OF THE. INVENTION
:LO
Ll A spinal implant comprising a hollow, generally tubular L2 shell having an exterior lateral surface, a first end and a 13 second end. The shell has a heli_al thread projecting from its 14 exterior surface, the thread comprising a plurality of pillars.
Each pillar has a height of l00-4500 microns and a lateral 16 dimension at the widest point of 100-4500 microns. The exterior 17 surface has a plurality of holes therethrough to permit bone 18 qrowth therethrough. Alternatively, a plurality of pillars may 19 project from the exterior surface of the shell in a regular, non-helical array.
24 FIG. l is a side elevational view of a spinal implant according to the invention.
26 FIG. 2 is a cross-sectional view taken along line 2-2 of 27 Fig. l.
28 FIG. 3 is a plan view of a portion of the outer surface of 29 the implant of Fig. l.
FIG. 4 is a cross-sectional view taken along line 4-4 of 31 Fig. 3.
32 FIG. 5 is a plan view of an alternative embodiment of the 33 surface of Fig. 3.
34 FIG. 6 is a cross-sectional view taken along line 6-6 of Fig. 5-1 FIG. 7 is a cross-sectional view similar to Fig. 6 showing 2 an alternative embodiment.
3 FIG. 8 is a cross-sectional view similar to Fig. 7 showing 4 an alternative embodiment.
FIG. 8A is a cross-sectional view similar to Fig. 4 showing 6 an alternative embodiment.
7 FIG. 9 is a cross-sectional view similar to Fig. 8 showing 8 an alternative embodiment.
9 FIG. 10 is a cross-sectional view similar to Fig. 7 showing an alternative embodiment.
ll FIG. 11 is a cross-sectional view similar to Fig. 10 showing 12 an alternative embodiment.
13 FIG. llA is a plan view simi]ar to Fig. 5 with the top half 14 of each pillar removed showing an alternative embodiment.
FIG. 12 is a plan view similar to Fig. 5 showing an 16 alternative embodiment.
17 FIG. 13 is a plan view similar to Fig. 12 showing an 18 alternative embodiment.
19 FIG. 14 is a plan view similar to Fig. 13 showing an alternative embodiment.
21 FIG. 15 is a plan view similar to Fig. 13 showing an 22 alternative embodiment.
23 FIG. 16 is a plan view similar to Fig. 15 showing an 24 alternative embodiment.
FIG. 17 is a plan view similar to Figs. 5 and 12 showing an 26 alternative embodiment.
27 FIG. 18 is a plan view similar to Fig. 17 showing an 28 alternative embodiment.
29 FIG. 19 is a plan view similar to Fig. 18 showing an alternative embodiment.
31 FIG. 20 is a plan view similar to Fig. 17 showing an 32 alternative embodiment.
33 FIG. 21 is a plan view similar to Fig. 20 showing an 34 alternative embodiment.
FIG. 22 is a plan view of an alternative embodiment of a CA 02232723 l998-03-l9 1 pillar or fin.
2 FlG. 23 is a cross-sectional view of an alternative 3 embodiment of the implant of Fig. 1.
4 FIG. 24 is a cross-sectional view of an alternative embodiment of the implant of Fig. 1.
]O Generally, the same number is used to identify the same ]1 element which appears in different Figures. With reference to ]2 F'igs. 1-2, there is shown a spinaL implant 10 of a conventional ]3 material such as titanium or other metal or metal alloy having 14 t:hreads or thread segments 12; the spinal implant 10 preferably 'L5 has only one thread which spirals helically around the implant :L6 approximately eight times, a single spiral or helical thread at :L7 t:welve threads per inch being known in the art. Thread 12 :L8 spirals helically around the implant 10 in the conventional :L9 manner, less preferably a plurality of intertwined helical threads may be provided. Space, or valleys 15 are provided ;71 between the threads; preferably, as known in the art, there is 22 only a single valley 15 which spirals helically around the 23 implant approximately eight times and which is defined by the 24 turns of the helical thread. Less preferably the valley 15 can :25 be flat across instead of trough-shaped, so that there is no dip, 26 so that a flat surface joins the base surface 32 of one thread 27 with the base surface 32 of the adjacent thread. A terminal :28 portion 14 of the thread is shown at one end of the implant. The ~9 implant 10 includes a hollow, generally tubular, preferably generally cylindrical shell as shown in Figs. 1-2 and has an 31 exterior lateral surface having a helical thread 12 projecting 32 therefrom as shown in Fig. 1. The cross-section of the 33 cylindrical shell of the implant 10 is preferably circular as 34 known in the art; less preferably it is oval as shown in Fig. 23, :Less preferably rectangular or rectangular with rounded ends as 1 shown in Fig. 24 (like a squashed oval). The implant 10 has a 2 leading or first end 7 and a trailing or second end 8; the 3 helical nature of thread 12 permits thread 12 to engage vertebra 4 material as the implant is screwed in (with leading end 7 leading the way) and draw the implant into the spine. The implant has 6 a longitudinal axis down the ce~ter of the cylinder and the 7 thread 12 is helically oriented around this axis.
8 As known in the art, a spinal implant is generally a hollow 9 threaded cylinder made of a titanium alloy, about 12-18 mm in L0 diameter and 20-28 mm in length. Polyethylene or plastic caps L1 may be used on the ends of the implant to maintain the cage 12 material inside. Inside the cylindrical spinal implant lO is a L3 first interior chamber lG, a second interior chamber 18, and 14 reinforcing ribs 20, 24, 26. I~oles 22 are provided radially through the side surface of the implant to permit bone growth 16 therethrough. Larger holes than those shown in Fig. 1 may also 17 be provided, as is known in the arlt (see U.S. Pat. No. 5,489,307, 18 incorporated herein by reference). The threads 12 comprise a 19 plurality of pillars or micropillars 6. Preferably the entirety of thread 12 or all the turns of thread 12 comprises pillars, 21 less preferably at least 75%, 50%, or 25% of thread 12 comprises 22 pillars. Pillars as used in the claims herein includes 23 cylindrical pillars, square pillars, rectangular pillars, and 24 crescent-shaped pillars.
With reference to Figs. 3-4, there is shown a detail of the 26 surface of the implant 10 showing pillars 6 extending from base 27 surface 32 of the thread 12, the threads being separated by 28 valleys 15. Each pillar 6 in Figs. 3-4 is essentially an 29 inverted truncated cone, each piLlar 6 having a truncated cone side surface 28 and a round top face 30. As shown in Fig. 4, the 31 side surface 28 of pillar 6 is undercut, having an undercut angle 32 A-A which is preferably 10~-20~.
33 With reference to Figs. 5-6, there is shown an alternative 34 embodiment comprising square four-sided truncated pyramidal pillars 34 extending from base surface 32 between valleys 15, 1 each pillar 34 being undercut by an angle C-C of preferably 10~-2 20~ on all four faces to yield side surface face 3~, the pillar 3 having a square top face 38. The base surface 32 is typically 4 about 900 microns wide.
With reference to Fig. 7, there is shown an alternative 6 embodiment wherein pillars 46, which may be cylindrical or square 7 as described above, extend from base surface 40, have a top face 8 44 and are undercut as described above yielding side surface 42.
9 With reference to Fig. 8, there is shown an alternative embodiment similar to Fig. 7, but wherein each pillar in Fig. 7 11 is replaced by a pair of pillars in Fig. 8; pillars 48, 50 12 extending from base surface 56 are the same and are side by side 13 (alternatively they are staggered), each pillar being square or 14 circular in top view, having a top face 54 and being undercut as described above to yield side sur-face 52. As shown in Fig. 8, 16 the pair of pillars 48, S0 define a line which is laterally 17 oriented with respect to the direction of the thread, that is, 18 the helical line defined by the helical thread.
19 Fig. 9 is an alternative embodiment similar to Fig. 8, wherein pillars 58, 60, which are circular or square in top view 21 and are the same and are side by side, extend from base surface 22 62, have a top surface 6~, and are undercut as described above 23 to yield a side surface 64.
24 Fig. 10 shows an alternative embodiment identical to Fig.
7, except that a pillar 70 is placed in each valley adjacent each 2~ pillar 68; each pillar 70 having the same dimensions as pillar 27 48. Fig. 11 shows an alternative embodiment similar to Fig. 10, 28 wherein pillars 72 are the same as pillars 70, but the threads 29 74, 76 are solid without pillars, thus having the appearance of a conventional thread, and having a sloping side surface having 31 an angle of about 5~, less preferably 1~-10~, as shown at K-K.
32 Fig. 12 is a plan view similar to Fig. 5 showing an 33 alternative embodiment wherein regularly-arrayed pillars or fins 34 78 are rectangular in top view and extend from base surface 79 to form threads which are separated by valleys 15.
CA 02232723 l998-03-l9 1 Alternatively, every other pillar 78 can be rotated 90~ so it is 2 oriented laterally rather than longitudinally. ~ig. 13 is an 3 alternative embodiment similar to Fig. 12, except that regularly-4 arrayed rectangular pillars 80 extending from base surface 81 are oriented laterally rather than longitudinally. Fig. 14 is an 6 alternative embodiment similar to Fig. 13, except that each 7 pillar 82 extending from base surface 83 is staggered between the 8 pillars in the adjacent threads, rather than being directly 9 across from the pillars in the adjacent threads.
~ig. 15 shows an alternative embodiment similar to Fig. 13, ]1 wherein each pillar 84a, 84b, and 84c extending from base surface 12 85 is angled with respect to the longitudinal axis of the thread ].3 on which it is placed, the angle being preferably 45~, less 'L4 preferably 30~-60~, angled having the conventional meaning of :L5 other than 0~, 90~ and 180~. As helical thread 12 progresses :L6 helically around implant 10, it travels 360~ each time or turn :L7 around the implant. As shown in Fig. 15, every 360~ or one turn :L8 around the implant, the angle of the pillars is rotated 90~ as :L9 shown in Fig. 15 so that the angle of the pillars alternates in ;'0 adjacent threads to yield a herringbone arrangement as shown in 21 Fig. 15. Holes 71a, 71b are provided in valleys 15a, 15c to ;72 permit bone chip placement or deposit therethrough as described 23 below, and subsequent bone growth therethrough. Since the ;74 implant is screwed into position in the spine of the patient, ;'5 each fin or pillar acts like a tiny snowplow blade pushing snow ;'6 to the side of the street; that is, as the implant is screwed in, 27 each fin shaves additional bone from the adjacent bony tissue and ;'8 pushed it in a certain direction. If the implant segment shown 29 in Fig. 15 is raked downwardly (corresponding to the implant :30 being screwed in), fins 84a will shave off bone chips or :31 fragments and push them toward holes 71a; fins 84b will shave off :32 bone fragments and push them in the opposite direction toward :33 holes 71b; fins 84c will shave off bone fragments and also push :34 them toward holes 7lb. Thus the holes are placed in every other :35 valley, not every valley, the holes being placed in the valleys 1 where the bone fragments are being pushed. Note valleys 15b and 2 15d do not have holes and the alternate valleys 15a and 15c do 3 have holes. The fins may be tilted toward the holes or undercut 4 more severely or with a concave surface on the side or portion facing the holes to assist in pushing the bone fragments down 6 toward the holes. In this way additional bony material is driven 7 down into the holes and into the implant as it is screwed in, or 8 at least driven toward or adjacent the holes to facilitate bone 9 growth through the holes. These concepts are further illustrated by Fig. 22, where a scalloped or crescent-shaped pillar or fin ll 100 having ends 101 and 102 is shown in top view. These fins 100 12 can be substituted for the fins in Fig. 15 and oriented on an 13 angle so as to scrape or shave off bone fragments and direct or ~4 push them towards the holes 7la, 7lb. The ends 101, 102 can alternatively be flat, have a blunt point, or have a small or 16 large radius of curvature. To be more effective, these fins for 17 scraping may be spaced further apart and placed in particular at 18 the leading end 7 of the implant 10. With regard to the l9 herringbone arrangement in Fig. 15, alternatively the angle of the pillars may be kept constant all over the implant and not 21 rotated periodically to form the herringbone arrangement. The 22 pillars can be staggered or un-,taggered with respect to the 23 pillars in adjacent threads. Alternatively the holes may be 24 placed in all the valleys or staggered or eliminated.
Fig. 16 shows an alternative embodiment similar to Fig. 15, 26 except that each pillar 86 extending from base surface 87 is 27 rotated 90~ from the orientation of the immediately preceding 28 pillar in the thread. The pillars 86 can be staggered or un-29 staggered with respect to the pillars in adjacent threads.
Any combinations of any of the arrangements described herein 31 can also be provided.
32 The pillars preferably or alternatively have a top face 33 which is somewhat rounded instead of flat and without sharp edges 34 which may have a potential for tissue necrosis. This can be 3S achieved by sandblasting the pillars after fabrication or 1 treating them chemically to take the edges off. This embodiment 2 is illustrated in Fig. 8A, which is the same as Fig. 4, except 3 that each pillar 6a has a top face 30a which is somewhat rounded 4 and the sharp edge where top face 30a meets side surface 28a has been removed, these changes being achieved by sandblasting or 6 chemical treatment. This feature is further illustrated in Fig.
7 llA, which is the same as Fig. 5, except that the top half of 8 each pillar 34 has been removed to show cutaway top surface 38a 9 and to illustrate that each of t:he four side edges 39 of the pillar 34 has been rounded (such as replaced by a radius of 11 curvature) and the sharp edge removed such as by sandblasting or 12 chemical treatment. Furthermore a radius of curvature or fillet 13 can be provided at or around the base of each pillar where it 14 joins or attaches to the surface.
In the Figures, dimension B-B in Fig. 4 is preferably 1000 16 microns and the following dimensions are preferably the following 17 lengths: D-D -- 1000 microns; E-E -- 500 microns; G-G -- 500 18 microns; J-J -- 500 microns. He:ight is measured from the base 19 surface to the top face, width is~measured at the top face (width of a circle being the diameter), and the edge-to-edge distance 21 is measured at the top face. In Fig. 8 the edge-to-edge distance 22 F-F is preferably 500 microns and in Fig. 9 the edge-to-edge 23 distance H-H is preferably 250 microns. In Figs. 3-6, the 24 pillars are preferably 1000 microns in width; in Fig. 7 the pillars are 500 microns in width, and in Figs. 8-9 the individual 26 pillars are 2S0 microns in width. The angles A-A and C-C are 27 preferably 10~-20~, less preferably 5~-30~. Less preferably 28 these angles may be 0~. Alternatively, the pillars may be wider 29 at the bottom than at the top, so that the side surfaces slope outward as they get closer to the base, by an amount such as 1~-31 30~, more preferably 1~-10~, more preferably 1~-5~. The valleys 32 lS are typically 250-3000, more preferably 500-2000, more 33 preferably about 1000, microns wi.de.
34 The pillars on the external surface of the spinal implant will help to more effectively mechanically anchor the implant at CA 02232723 l998-03-l9 l an early date and affix the implant into the adjoining bone and 2 more effectively reduce, minimize or disrupt fibrous capsule 3 formation around the implant.
4 The pillars of the implant are preferably inverted truncated cones or pyramids as illustrated, preferably with the above 6 dimensions. In Figs. 12-16, the pillars or fins have a 7 rectangular top face having a width of 100-1000, more preferably 8 200-950, more preferably 300-900, more preferably 400-825, more 9 preferably 500-750, less preferably about 250, less preferably ]L0 200-250, less preferably 150-300, microns and a length of 400-]Ll 4500, more preferably 500-3000, more preferably 600-2000, more ;L2 preferably 700-1750, more preferably 1000-1500, microns (the :L3 length being greater than the width and preferably being 2-lo, :L4 more preferably 2-6, more preferably 2-4, times the width);
:L5 otherwise these pillars are dimensionally the same as the pillars :L6 described above.
:L7 Less preferably the dimensions or distances of the pillars :L8 mentioned herein can be within a range +5~, less preferably +10%, :L9 less preferably +20%, less preferably +30~, less preferably +40%, less preferably +50%.
:71 The height of the pillars is preferably 100-4500 microns, ;~2 more preferably 100-2500 microns, more preferably 150-2000 23 microns, more preferably 200-1500 microns, more preferably 400-~4 1200 microns, more preferably 500-1000 microns, alternatively about 500 or 1000 microns. The width of the pillars is ;'6 preferably 100-4500, more preferably 100-3000, more preferably ;27 150-2000, more preferably 200-1500, more preferably 250-1000, ;28 microns. Where a pair of pillars is on the same thread as in 29 Fig. 8, the edge-to-edge distance is preferably 100-3000, more preferably 100-2000, more preferclbly 130-1000, more preferably 31 160-800, more preferably 200-600, more preferably 250-500, 32 microns. The lateral dimension at the widest point of each 33 pillar (for circular and square pillars the width and for 34 rectangular pillars the length) is preferably 100-4500, more preferably 150-2500, more preferably 200-1500, microns.
CA 02232723 l998-03-l9 1 Two adjacent pillars in the same thread (ie, without 2 crossing a valley) such as in Figs. 1, 18 and 19 have an edge-to-3 edge distance preferably the same as the width of the pillar or 4 alternatively 100-4500, more preferably 100-2000, more preferably 250-1000, microns or 250, 500 o.r 1000 microns. For fins or 6 rectangular pillars such as in Figs. 12-16, the edge-to-edge 7 distance is preferably about the width of the pillar, or loO-8 4500, more preferably 100-2500, more pre~erably 250-1000, 9 microns, or as shown in Figs. 12-lG, or 250, 500, or loOo microns.
11 Less preferably pillars such as those described above can 12 be placed on the interior surface of the implant (to help hold 13 the bone in place), but preferably without undercutting.
14 The metal surfaces of the implant can optionally be coated with hydroxy appetite, bone morphogenic protein, or other bone 16 inductive agents.
17 Conventional spinal implants are provided with large holes, 18 such as at 22 in Figs. 1-2, for bone growth therethrough. The 19 present invention also provides a plurality of smaller, more effective holes for bone growth therethrough. Fig. 17 is an 21 alternative embodiment similar to Figs. 5 and 12 showing valleys 22 15, pillars 88 extending from the base surface 32, and holes 90 23 provided between the pillars 88. Fig. 18 is an alternative 24 embodiment similar to Fig. 17 showing pillars 91 in the threads and holes 92 in the valleys 15...... Fig. 19 is an alternative 26 embodiment similar to Fig. 18 showing pillars 93 in the threads 27 and fin holes or rectangular holes 94 in the valleys 15. Fig.
28 20 is an alternative embodiment wherein the cylindrical surface 29 of the spinal implant 10 has a smooth unthreaded surface 95 from which the pillars 96, which are regularly-arrayed and non-31 helical, directly emerge, and has holes 97 between the pillars 32 96. Fig. 21 is an alternative embodiment similar to Fig. 20, 33 also having a smooth unthreaded surface 89 from which fins or 34 rectangular pillars 98, which are arrayed in a non-helical herringbone arrangement or herringbone type pattern, directly CA 02232723 l998-03-l9 1 emerge, interspersed with holes 95~.
2 With reference to Figs. 17-21, the pillars may be any of the 3 pillars described herein. The round holes go through the wall of 4 the implant into the interior chamber and are preferably 150-1500, more preferably 200-1250, more preferably 250-1000, 6 alternatively 375-750, alternative]y 450-575, alternatively about 7 500, microns in diameter, with 250, 500, and 1000 microns being 8 typical hole diameters. The rectangular holes 94 have the same 9 width and length dimensions as the width and length dimensions of the pillars or fins in Figs. 12--16. Rectangular holes may be 11 substituted for round holes and vice versa. I~ectanyular holes 12 may be oriented longitudinally or laterally or at an angle or a 13 combination thereof, such as alternating longitudinal and 14 lateral, or oriented as the fins in Figs. 12-16 are oriented.
The holes may be staggered or unstaggered with respect to each 16 other and with respect to the pillars. The pillars may be 17 staggered or unstaggered with respect to each other and with 18 respect to the holes. Any of the foregoing arrangements may be 19 combined on the same implant, sucl-l as the holes in Figs. 17 and 18 being placed into the same imp]ant.
21 Although the preferred embodiments of the invention have 22 been shown and described, it should be understood that various 23 modifications may be resorted to without departing from the scope 24 of the invention as disclosed and claimed herein.
Claims (19)
1. A spinal implant comprising a hollow, generally tubular shell having an exterior lateral surface, a first end, and a second end, said shell having a helical thread projecting from said exterior surface, said thread comprising a plurality of pillars, each pillar having a height of 100-4500 microns and a lateral dimension at the widest point of 100-4500 microns, said exterior surface having a plurality of holes therethrough to permit bone growth therethrough.
2. A spinal implant according to claim 1, each pillar being substantially circular or substantially square in top view and having a height of 150-2000 microns, a width of 200-1500 microns, and adjacent pillars in the same thread having an edge-to-edge distance of 100-4500 microns.
3. A spinal implant according to claim 1, each pillar being substantially rectangular in top view and having a width of 100-1000 microns and a length of 400-4500 microns and a height of 150-2000 microns, and adjacent pillars in the same thread having an edge-to-edge distance of 100-4500 microns.
4. A spinal implant according to claim 1, a plurality of said pillars having a side surface which is undercut at an undercut angle of 5°-30°.
5. A spinal implant according to claim 1, said thread comprising a plurality of pairs of pillars, each pair of pillars being two pillars which are side-by-side, each pair defining a line which is laterally oriented with respect to the direction of the thread.
6. A spinal implant according to claim 1, each pillar being substantially without sharp edges.
7. A spinal implant according to claim 1, said helical thread defining a helical valley between turns of said thread, a plurality of pillars projecting from said valley.
8. A spinal implant according to claim 3, at least some of said rectangular pillars being oriented laterally in said thread.
9. A spinal implant according to claim 3, said thread having a longitudinal axis, at least some of said rectangular pillars being angled with respect to said longitudinal axis of said thread.
10. A spinal implant according to claim 3, said rectangular pillars being provided in a herringbone arrangement.
11. A spinal implant according to claim 10, said helical thread defining a helical valley between turns of said thread, a plurality of holes being provided in said valley through said shell.
12. A spinal implant according to claim 1, a hole through said shell being provided between each pair of said pillars which are adjacent one another in said thread.
13. A spinal implant according to claim 1, said helical thread defining a helical valley between turns of said thread, a plurality of holes being provided in said valley through said shell.
14. A spinal implant according to claim 1, said implant being coated with bone inductive agent.
15. A spinal implant according to claim 1, wherein said generally tubular shell is cylindrical.
16. A spinal implant comprising a hollow, generally tubular shell having an exterior lateral surface, a first end, and a second end, a plurality of pillars projecting from said exterior surface in a regular, non-helical array, each pillar having a height of 100-4500 microns and a lateral dimension at the widest point of 100-4500 microns, said exterior surface having a plurality of holes therethrough to permit bone growth therethrough.
17. A spinal implant according to claim 16, each pillar being substantially rectangular in top view and having a width of 100-1000 microns and a length of 400-4500 microns and a height of 150-2000 microns.
18. A spinal implant according to claim 17, said rectangular pillars being arrayed in a non-helical herringbone arrangement.
19. A spinal implant according to claim 16, wherein said generally tubular shell is cylindrical.
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US08/859,577 US5876457A (en) | 1997-05-20 | 1997-05-20 | Spinal implant |
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- 1998-03-19 CA CA002232723A patent/CA2232723A1/en not_active Abandoned
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- 1998-05-19 JP JP10137272A patent/JPH10328217A/en not_active Withdrawn
- 1998-11-23 US US09/197,819 patent/US6071310A/en not_active Expired - Lifetime
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2001
- 2001-12-05 US US10/011,338 patent/US7556648B2/en not_active Expired - Lifetime
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US20020040242A1 (en) | 2002-04-04 |
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