US20080039945A1 - Spine distraction implant and method - Google Patents
Spine distraction implant and method Download PDFInfo
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- US20080039945A1 US20080039945A1 US11/768,957 US76895707A US2008039945A1 US 20080039945 A1 US20080039945 A1 US 20080039945A1 US 76895707 A US76895707 A US 76895707A US 2008039945 A1 US2008039945 A1 US 2008039945A1
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- implant
- implant member
- spinous processes
- wing
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- KWVFUKQIZZANSC-UHFFFAOYSA-N CC1C(CC2)C2CCC1 Chemical compound CC1C(CC2)C2CCC1 KWVFUKQIZZANSC-UHFFFAOYSA-N 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/366—Lactones having six-membered rings, e.g. delta-lactones
- A61K31/37—Coumarins, e.g. psoralen
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7062—Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
- A61B17/7065—Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7062—Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
- A61B17/7068—Devices comprising separate rigid parts, assembled in situ, to bear on each side of spinous processes; Tools therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/60—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like for external osteosynthesis, e.g. distractors, contractors
- A61B17/66—Alignment, compression or distraction mechanisms
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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
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7047—Clamps comprising opposed elements which grasp one vertebra between them
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7071—Implants for expanding or repairing the vertebral arch or wedged between laminae or pedicles; Tools therefor
Abstract
Description
- This application is a continuation of each of U.S. patent application Ser. No. 11/806,529 (Attorney Docket No. KYPH-039/10US 305363-2188) and Ser. No. 11/806,527 (Attorney Docket No. KYPH-039/11US 305363-2189), each entitled “Spine Distraction Implant and Method,” and filed May 31, 2007; each of which is incorporated herein by reference in its entirety.
- Each of U.S. patent application Ser. No. 11/806,529 (Attorney Docket No. KYPH-039/10US 305363-2188) and Ser. No. 11/806,527 (Attorney Docket No. KYPH-039/11US 305363-2189) is a continuation-in-part of U.S. patent application Ser. No. 11/092,862, entitled “Supplemental Spine Fixation Device and Method,” filed Mar. 29, 2005, which is a divisional application of U.S. patent application Ser. No. 09/842,819, entitled “Supplemental Spine Fixation Device,” filed Apr. 26, 2001, now U.S. Pat. No. 7,201,751, which claims priority to U.S. Provisional Application Ser. No. 60/219,985, entitled “Supplemental Spine Fixation Device and Method,” filed Jul. 21, 2000 and which is a continuation-in-part of U.S. patent application Ser. No. 09/579,039, entitled “Supplemental Spine Fixation Device and Method,” filed May 26, 2000, now U.S. Pat. No. 6,451,019, which is a continuation-in-part of U.S. patent application Ser. No. 09/473,173, entitled “Spine Distraction Implant,” filed Dec. 28, 1999, now U.S. Pat. No. 6,235,030, which is a continuation of U.S. patent application Ser. No. 09/179,570, entitled “Spine Distraction Implant,” filed October 27, 1998, now U.S. Pat. No. 6,048,342, which is a continuation-in-part of U.S. patent application Ser. No. 08/958,281, entitled “Spine Distraction Implant and Method,” filed Oct. 27, 1997, now U.S. Pat. No. 5,860,977, which is a continuation-in-part of U.S. patent application Ser. No. 08/778,093, entitled “Spine Distraction Implant and Method,” filed Jan. 2, 1997, now U.S. Pat. No. 5,836,948; each of which is incorporated herein by reference in its entirety.
- Each of U.S. patent application Ser. No. 11/806,529 (Attorney Docket No. KYPH-039/10US 305363-2188) and Ser. No. 11/806,527 (Attorney Docket No. KYPH-039/11US 305363-2189) is a continuation-in-part of U.S. patent application Ser. No. 10/747,534, entitled “Interspinous Process Distraction System and Method With Positionable Wing and Method,” filed Dec. 29, 2003, which is a continuation of U.S. patent application Ser. No. 10/014,118, entitled “Interspinous Process Distraction System and Method With Positionable Wing and Method,” filed Oct. 26, 2001, now U.S. Pat. No. 6,695,842, which claims priority to U.S. Provisional Application Ser. No. 60/306,263, entitled “Interspinous Process Distraction System and Method With Positionable Wing and Method,” filed Jul. 18, 2001 and which is a continuation-in-part of U.S. patent application Ser. No. 09/799,215, entitled “Spine Distraction Implant,” filed Mar. 5, 2001, now U.S. Pat. No. 7,101,375, which is a continuation-in-part of U.S. patent application Ser. No. 09/473,173, entitled “Spine Distraction Implant,” filed Dec. 28, 1999, now U.S. Pat. No. 6,235,030, which is a continuation of U.S. patent application Ser. No. 09/179,570, entitled “Spine Distraction Implant,” filed Oct. 27, 1998, now U.S. Pat. No. 6,048,342, which is a continuation-in-part of U.S. patent application Ser. No. 08/958,281, entitled “Spine Distraction Implant and Method,” filed Oct. 27, 1997, now U.S. Pat. No. 5,860,977, which is a continuation-in-part of U.S. patent application Ser. No. 08/778,093, entitled “Spine Distraction Implant and Method,” filed Jan. 2, 1997, now U.S. Pat. No. 5,836,948; each of which is incorporated herein by reference in its entirety.
- Each of U.S. patent application Ser. No. 11/806,529 (Attorney Docket No. KYPH-039/10US 305363-2188) and Ser. No. 11/806,527 (Attorney Docket No. KYPH-039/11US 305363-2189) is a continuation-in-part of U.S. patent application Ser. No. 10/037,236, entitled “Interspinous Process Implant and Method With Deformable Spacer,” filed Nov. 9, 2001, which claims priority to U.S. Provisional Application Ser. No. 60/323,467, entitled “Interspinous Process Implant and Method With Deformable Spacer,” filed Sep. 18, 2001 and which is a continuation-in-part of U.S. patent application Ser. No. 09/799,215, entitled “Spine Distraction Implant,” filed Mar. 5, 2001, now U.S. Pat. No. 7,101,375, which is a continuation-in-part of U.S. patent application Ser. No. 09/473,173, entitled “Spine Distraction Implant,” filed Dec. 28, 1999, now U.S. Pat. No. 6,235,030, which is a continuation of U.S. patent application Ser. No. 09/179,570, entitled “Spine Distraction Implant,” filed Oct. 27, 1998, now U.S. Pat. No. 6,048,342, which is a continuation-in-part of U.S. patent application Ser. No. 08/958,281, entitled “Spine Distraction Implant and Method,” filed Oct. 27, 1997, now U.S. Pat. No. 5,860,977, which is a continuation-in-part of U.S. patent application Ser. No. 08/778,093, entitled “Spine Distraction Implant and Method,” filed Jan. 2, 1997, now U.S. Pat. No. 5,836,948; each of which is incorporated herein by reference in its entirety.
- Each of U.S. patent application Ser. No. 11/806,529 (Attorney Docket No. KYPH-039/10US 305363-2188) and Ser. No. 11/806,527 (Attorney Docket No. KYPH-039/11US 305363-2189) is a continuation-in-part of U.S. patent application Ser. No. 10/770,372, entitled “Mating Insertion Instruments for Spinal Implants and Methods of Use,” filed Feb. 2, 2004, which is a divisional application of U.S. patent application Ser. No. 09/981,859, entitled “Mating Insertion Instruments for Spinal Implants and Methods of Use,” filed Oct. 18, 2001, now U.S. Pat. No. 6,712,819, which claims priority to U.S. Provisional Application Ser. No. 60/306,101, entitled “Mating Insertion Instruments for Spinal Implants and Methods of Use,” filed Jul. 17, 2001 and which is a continuation-in-part of U.S. patent application Ser. No. 09/799,470, entitled “Spinal Implants, Insertion Instruments, and Methods of Use,” filed Mar. 5, 2001, now U.S. Pat. No. 6,902,566, which claims priority to U.S. Provisional Application Ser. No. 60/220,022, entitled “Spinal Implants, Insertion Instruments, and Methods of Use,” filed Jul. 21, 2000 and which is a continuation-in-part of U.S. patent application Ser. No. 09/474,037, entitled “Spine Distraction Implant,” filed Dec. 28, 1999, now U.S. Pat. No. 6,190,387, which is a divisional application of U.S. patent application Ser. No. 09/175,645, entitled “Spine Distraction Implant,” filed Oct. 20, 1998, now U.S. Pat. No. 6,068,630, which is a continuation-in-part of U.S. patent application Ser. No. 08/958,281, entitled “Spine Distraction Implant and Method,” filed Oct. 27, 1997, now U.S. Pat. No. 5,860,977, which is a continuation-in-part of U.S. patent application Ser. No. 08/778,093, entitled “Spine Distraction Implant and Method,” filed Jan. 2, 1997, now U.S. Pat. No. 5,836,948; each of which is incorporated herein by reference in its entirety. U.S. patent application Ser. No. 09/799,470, is also a continuation-in-part of U.S. patent application Ser. No. 09/473,173 entitled “Spine Distraction Implant,” filed Dec. 28, 1999, now U.S. Pat. No. 6,235,030, which is a continuation of U.S. patent application Ser. No. 09/179,570, entitled “Spine Distraction Implant,” filed Oct. 27, 1998, now U.S. Pat. No. 6,048,342, which is a continuation-in-part of U.S. patent application Ser. No. 08/958,281, entitled “Spine Distraction Implant and Method,” filed Oct. 27, 1997, now U.S. Pat. No. 5,860,977, which is a continuation-in-part of U.S. patent application Ser. No. 08/778,093, entitled “Spine Distraction Implant and Method,” filed Jan. 2, 1997, now U.S. Pat. No. 5,836,948; each of which is incorporated herein by reference in its entirety. U.S. patent application Ser. No. 09/799,470, is also a continuation-in-part of U.S. patent application Ser. No. 09/200,266 entitled “Spine Distraction Implant and Method,” filed Nov. 25, 1998, now U.S. Pat. No. 6,183,471, which is a continuation of U.S. patent application Ser. No. 09/139,333, entitled “Spine Distraction Implant and Method,” filed Aug. 25, 1998, now U.S. Pat. No. 5,876,404, which is a continuation of U.S. patent application Ser. No. 08/958,281, entitled “Spine Distraction Implant and Method,” filed Oct. 27, 1997, now U.S. Pat. No. 5,860,977, which is a continuation-in-part of U.S. patent application Ser. No. 08/778,093, entitled “Spine Distraction Implant and Method,” filed Jan. 2, 1997, now U.S. Pat. No. 5,836,948; each of which is incorporated herein by reference in its entirety.
- As the present society ages, it is anticipated that there will be an increase in adverse spinal conditions which are characteristic of older people. By way of example, with aging comes increases in spinal stenosis (including but not limited to central canal and lateral stenosis), the thickening of the bones which make up the spinal column and facet arthropathy. Spinal stenosis is characterized by a reduction in the available space for the passage of blood vessels and nerves. Pain associated with such stenosis can be relieved by medication and/or surgery. Of course, it is desirable to eliminate the need for major surgery for all individuals and in particular for the elderly.
- Accordingly, there needs to be developed procedures and implants for alleviating such condition which are minimally invasive, can be tolerated by the elderly and can be performed preferably on an outpatient basis.
- The present invention is directed to providing a minimally invasive implant and method for alleviating discomfort associated with the spinal column.
- The present invention provides for apparatus and method for relieving pain by relieving the pressure and restrictions on the aforementioned blood vessels and nerves. Such alleviation of pressure is accomplished in the present invention through the use of an implant and method which distract the spinous process of adjacent vertebra in order to alleviate the problems caused by spinal stenosis and facet arthropathy and the like. While the implant and method particularly address the needs of the elderly, the invention can be used with individuals of all ages and sizes where distraction of the spinous process would be beneficial.
- In one aspect of the invention, an implant is provided for relieving pain comprising a device positioned between a first spinous process and a second spinous process. The device includes a spinal column extension stop and a spinal column flexion non-inhibitor.
- In another aspect of the invention, the implant is positioned between the first spinous process and the second spinous process and includes a distraction wedge that can distract the first and second spinous processes as the implant is positioned between the spinous processes.
- In yet another aspect of the present invention, the implant includes a device which is adapted to increasing the volume of the spinal canal and/or the neural foramen as the device is positioned between adjacent spinous processes.
- In yet a further aspect of the present invention, a method is presented for relieving pain due to the development of, by way of example only, spinal stenosis and facet arthropathy. The method is comprised of the steps of accessing adjacent first and second spinal processes of the spinal column and distracting the processes a sufficient amount in order to increase the volume of the spinal canal in order to relieve pain. The method further includes implanting a device in order to maintain the amount of distraction required to relieve such pain.
- In yet a further aspect of the invention, the method includes implanting a device in order to achieve the desired distraction and to maintain that distraction.
- In yet a further aspect of the invention, the implant includes a first portion and a second portion. The portions are urged together in order to achieve the desired distraction.
- In still a further aspect of the invention, the implant includes a distracting unit and a retaining unit. The distracting unit includes a body which can be urged between adjacent spinous processes. The body includes a slot. After the distracting unit is positioned, the retaining unit can fit into the slot of the retaining unit and be secured thereto.
- In yet a further aspect of the invention, the implant includes a first unit with a central body. A sleeve is provided over the central body and is at least partially spaced from the central body in order to allow for deflection toward the central body.
- In a further aspect of the invention, the implant includes a first unit having a central body with a guide and a first wing, with the first wing located at first end of the body. The guide extends from a second end of the body located distally from the first wing. The implant further includes a sleeve provided over said central body. The sleeve is at least partially spaced from the central body in order to allow for deflection of the sleeve toward the central body. The implant further includes a second wing and a device for securing the second wing to the first unit, wherein the sleeve is located between the first and second wings.
- In yet another aspect of the invention, an implant system includes a cylindrical sleeve which is inwardly deflectable. The system further includes an insertion tool which includes an insertion guide, a central body, a stop and a handle. The guide and the stop extend from opposite sides of the central body and the handle extend from the stop. A sleeve fits over the guide and against the stop preparatory to being positioned between the two adjacent vertebrae with the insertion tool.
- In yet a further aspect of the invention, the implant includes central body and first and second wings and a means for selectively positioning one of the first and second wings relative to the other in order to accommodate spinous processes of different sizes.
- Other implants and methods within the spirit and scope of the invention can be used to increase the volume of the spinal canal thereby alleviating restrictions on vessels and nerves associated therewith, and pain.
-
FIGS. 1 and 2 depict an embodiment of an implant of the invention which is adjustable in order to select the amount of distraction required.FIG. 1 depicts the implant in a more extended configuration than doesFIG. 2 . -
FIGS. 3 a and 3 b depict side and end views of a first forked and of the embodiment ofFIG. 1 . -
FIGS. 4 a and 4 b depict side sectioned and end views of an interbody piece of the implant ofFIG. 1 . -
FIGS. 5 a and 5 b depict side and end views of a second forked end of the embodiment ofFIG. 1 . -
FIGS. 6, 7 , 8, 9 and 10 depict apparatus and method for another embodiment of the present invention for creating distraction between adjacent spinous processes. -
FIGS. 11, 12 and 13 depict yet a further embodiment of the invention for creating distraction between adjacent spinous processes. -
FIGS. 14 and 15 depict a further apparatus and method of an embodiment of the invention for creating distraction. -
FIGS. 16, 16 a, and 17 depict yet another embodiment of the present invention. -
FIGS. 18, 19 and 20 depict yet a further apparatus and method of the present embodiment. -
FIGS. 21 and 22 depict still a further embodiment of the present invention. -
FIGS. 23, 24 and 25 depict another embodiment of the present invention. -
FIGS. 26, 27 and 28 depict another embodiment of the invention. -
FIGS. 29 and 30 depict side elevational views of differently shaped implants of embodiments of the present invention. -
FIGS. 31, 32 and 33 depict various implant positions of an apparatus of the present invention. -
FIGS. 34 and 35 depict yet another apparatus and method of the present invention. -
FIGS. 36, 37 and 38 depict three different embodiments of the present invention. -
FIGS. 39 and 40 depict yet another apparatus and method of an embodiment of the present invention. -
FIGS. 41, 42 and 43 depict yet further embodiments of an apparatus and method of the present invention. -
FIG. 44 is still a further embodiment of an implant of the invention. -
FIG. 45 is yet another depiction of an apparatus and method of the invention. -
FIGS. 46 and 47 depict still a further apparatus and method of an embodiment of the invention. -
FIGS. 48, 49 , 50 and 51 depict yet a further apparatus and method of the invention. -
FIGS. 52, 53 , 54, 55 a and 55 b depict another apparatus and method of the invention. -
FIGS. 56, 57 and 58 depict yet a further apparatus and method of the invention. -
FIGS. 59 and 60 depict still a further embodiment of the invention. -
FIG. 61 depict another embodiment of the invention. -
FIGS. 62 and 63 depict yet another embodiment of the present invention. -
FIGS. 64 and 65 depict still a further embodiment of the present invention. -
FIG. 66 depicts another embodiment of the invention. -
FIGS. 67 and 68 depict yet another embodiment of the present invention. -
FIGS. 69, 70 , 71 and 71 a depict a further embodiment of the present invention. -
FIGS. 72 and 73 depict still another embodiment of the invention. -
FIGS. 74, 75 , 76, 77, and 78 depict still other embodiments of the invention. -
FIGS. 79, 80 , 80 a, 81, 82, 83, 83 a, 84, 85, 86 and 87 depict still a further embodiment of the present invention. -
FIGS. 88, 89 , 90 and 91 depict yet another embodiment of the present invention. -
FIGS. 92, 92 a, 92 b, 93, 93 a, 93 b, 93 c, 93 d, 94, 94 a, 94 b, 95, 95 a, an depict still a further embodiment of the present invention wherein a sleeve is provided which is capable of deflecting response to relative motion between the spinous processes. -
FIG. 97 depicts still another embodiment of the present invention. -
FIG. 98 depicts yet a further embodiment of the present invention. -
FIGS. 99 and 100 depict still another embodiment of the present invention including an insertion tool. -
FIGS. 101, 102 , 102 a, 103, 104, 105, 106, and 107 depict still a further embodiment of the present invention. -
FIGS. 108, 109 , and 110 depict still another embodiment of the present invention. -
FIGS. 111, 112 , 113, 114, 115, 116, and 117 depict yet another embodiment of the present invention. -
FIG. 118 depicts a graph showing characteristics of a preferred material usable with several of the embodiments of the present invention. -
FIGS. 119 a and 119 b depict side and plan views of still a further embodiment of the present invention. -
FIGS. 120 a and 120 b depict side and plan views of the second wing which can be used in conjunction with the embodiment of the invention ofFIGS. 119 a and 119 b. -
FIGS. 121 a and 121 b depict side and plan views of the first wing and central body of the embodiment of the invention depicted inFIGS. 119 a and 119 b. -
FIGS. 122 a, 122 b, and 122 c depict top, side and end views of a guide which is a portion of the embodiment of the invention ofFIGS. 119 a and 119 b. -
FIGS. 123 a and 123 b depict an end view and a cross-sectioned view respectfully of the sleeve of the embodiment of the invention ofFIGS. 119 a and 119 b. -
FIGS. 124 a, 124 b and 124 c depict a view of the embodiment of the invention ofFIGS. 119 a and 119 b taken through line 124-124 inFIG. 119 b shown in with the sleeve in various positions relative to a first wing. -
FIG. 125 depicts an alternative embodiment of the invention as depicted inFIGS. 119 a and 119 b. -
FIG. 126 depicts yet a further alternative embodiment of the invention depicted inFIGS. 119 a and 119 b. -
FIG. 127 depicts yet a further embodiment of the invention as depicted inFIGS. 119 a and 119 b. -
FIG. 128 is still a further embodiment of the invention as depicted inFIG. 93 a. -
FIG. 129 depicts still a further embodiment of the invention as depicted inFIGS. 119 a and 119 b. -
FIG. 130 is a perspective view of a first embodiment of the invention. -
FIG. 131 is an exploded view of the embodiment of the invention ofFIG. 130 .FIG. 131 a and 131 b are alternative components of the embodiment ofFIG. 131 . -
FIG. 132 is a plan view of the embodiment of the invention ofFIG. 130 . -
FIGS. 133 a, 133 b, 133 c, and 133 d are perspective, first end, second end, and sectional views of a spacer or sleeve of the embodiment of the invention depicted inFIG. 130 . -
FIG. 134 is a cross sectional view of an embodiment of the invention taken through line 134-134 inFIG. 132 . -
FIGS. 135 a-135 f are various views of an embodiment of the hook mechanism of the embodiment of the invention ofFIG. 130 . -
FIG. 136 is a schematical representation of an embodiment of the invention as positioned with respect to adjacent spinous processes. -
FIG. 137 is a perspective view of another embodiment of the invention. -
FIG. 138 is an exploded view of the embodiment of the invention ofFIG. 137 . -
FIG. 138 a is an alternative component of the embodiment ofFIG. 137 . -
FIG. 138 b is an upside down perspective view of a component of the embodiment ofFIG. 138 . -
FIG. 139 is a plan view of the embodiment of the invention ofFIG. 137 . -
FIG. 140 is a partial section view taken through line 140-140 ofFIG. 139 . -
FIG. 141 is an exploded view of yet another embodiment of the invention.FIG. 141 a is an upside down perspective view of a component of the embodiment ofFIG. 141 . -
FIG. 142 is a sectional view of a body portion of the embodiment of the invention ofFIG. 141 taken through line 142-142. -
FIG. 143 is a top view of the body portion shown inFIG. 142 . -
FIG. 144 is a sectional view of yet another embodiment of a body portion of the invention. -
FIG. 145 is a perspective view of yet a further embodiment of the body portion of the invention. -
FIGS. 146 a, 146 b, and 146 c depict yet a further embodiment of a body portion of the invention. -
FIGS. 147 a and 147 b are side and top views of yet another embodiment of the invention depicting a mechanism for adjusting the positions of the hook mechanisms of, for example, the embodiment of the invention ofFIGS. 130, 137 , and 141. -
FIGS. 148 a and 148 b are sectional top and side views of yet another embodiment of the invention for adjusting the position of the hook mechanisms. -
FIGS. 149 a and 149 b are perspective and side views of yet a further mechanism of an embodiment of the invention for adjusting the position of hook mechanisms of the invention. -
FIG. 150 is a perspective view of yet a further embodiment of the invention. -
FIG. 151 is a perspective view of an embodiment of the invention which is addressable to multiple levels of spinous processes. -
FIG. 152 is a perspective view of an alternative embodiment of the supplemental spine fixation device of the invention. -
FIG. 153 is an exploded view of the embodiment of the invention ofFIG. 152 . -
FIG. 154 a is a sectioned view of the spacer and lead-in nose tissue expander of the invention. -
FIG. 154 b is an end view of a spacer ofFIG. 154 a. -
FIG. 154 c is an exploded view of several of the components ofFIG. 154 a. -
FIG. 155 a is a plan, partially sectioned view of an embodiment of a hook of the invention. -
FIG. 155 b is a sectioned view taken throughline 155 b-155 b ofFIG. 155 a. -
FIG. 155 c is a sectioned view taken throughline 155 c-155 c ofFIG. 155 a. -
FIG. 155 d is a bottom view of the embodiment of the hook of the invention of 155 a. -
FIG. 155 e is an end view ofFIG. 155 d. -
FIG. 156 is a view of an embodiment of a shaft arrangement of the invention upon which hooks can be mounted. -
FIG. 157 is an alternate view of the top member of the hub showing the locking mechanism. -
FIGS. 158 a and 158 b are sectioned views of an alternate embodiment of the hub mechanism of the invention. -
FIG. 159 is an alternate embodiment of the hook attached to a shaft of the invention. -
FIG. 160 is an alternate embodiment of a sleeve of the invention positioned between adjacent spinous processes. -
FIGS. 161 a, 161 b and 161 c are top, side, and side sectioned views respectively of an embodiment of a lead-in nose, guide, or tissue expander of the invention. -
FIG. 161 d is a left-end view ofFIG. 161 c. -
FIG. 161 e is a right-end view ofFIG. 161 c. -
FIG. 162 is an alternate embodiment of a second wing of the invention usable with the guide or tissue expander inFIG. 161 a-161 e. -
FIG. 163 a is yet a further embodiment of the spacer of the invention which is substantially egg-shaped and positional between adjacent spinous processes. -
FIG. 163 b is an end view of the base of a lead-in nose usable with the spacer ofFIG. 163 a. -
FIG. 163 c is a side view of an embodiment of an implant of the invention implanted in the spine, the implant having at least a first wing. -
FIG. 164 is a perspective view of an embodiment of the present invention. -
FIG. 165 is a top view of an embodiment of the adjustable wing of the present invention. -
FIG. 166 is a perspective view of an embodiment of the fastener used in the present invention. -
FIG. 167 is cut-away view illustrating the interaction between the fastener and the adjustable wing with the adjustable wing is in a first position. -
FIG. 168 is a cut-away view illustrating the fastener engaging the adjustable wing with the adjustable wing in a second position. -
FIG. 169 is a side view illustrating an embodiment of the present invention as implanted between adjacent spinous processes. -
FIG. 170 is a front view of an embodiment of the present invention as implanted between adjacent spinous processes. -
FIG. 171 a is an assembly view of an embodiment of the invention -
FIG. 171 b is a side view of the embodiment of the invention ofFIG. 171 a including a spacer, a main body and a first wing. -
FIG. 171 c is a plane view of the embodiment of the invention inFIG. 171 b. -
FIG. 171 d is a side view illustrating the second wing of the embodiment of the invention inFIG. 171 a. -
FIG. 171 e is a plane view of the second wing of an embodiment of the invention ofFIG. 171 a. -
FIG. 171 f is an end view of the spacer of the embodiment of the invention ofFIG. 171 a. -
FIG. 171 g is a cut-away view illustrating the spacer of the embodiment of the invention ofFIG. 171 a. -
FIG. 172 is a perspective view of still another embodiment of the spacer of the invention. -
FIG. 173 is a perspective view of yet another embodiment of the spacer of the invention. -
FIG. 174 is a perspective view of still another embodiment of the spacer of the invention. -
FIG. 175 a is a perspective view of yet another embodiment of the spacer of the invention. -
FIG. 175 b is an end view of the embodiment of the spacer illustrated inFIG. 175 a. -
FIG. 176 a is a perspective view of yet another embodiment of the spacer of the invention. -
FIG. 176 b is a perspective view of the first outer shell of the spacer illustrated inFIG. 176 a. -
FIG. 176 c is an end view of the embodiment of the spacer shown inFIG. 176 a filled with a deformable or compressible material. -
FIG. 177 is a perspective view of yet another embodiment of the spacer of the invention. -
FIGS. 178 a-178 b are perspective views of still other embodiments of the spacer of the invention. -
FIG. 179 a is a perspective view of another embodiment of the present invention. -
FIG. 179 b is a cut-away view of the embodiment of the invention illustrated inFIG. 9 a. -
FIG. 180 depicts an exterior view of a main body insertion instrument of one embodiment of this invention for inserting an implant body into the spine of a patient. -
FIG. 181 depicts a schematic, sectional, longitudinal view of a main body insertion instrument as depicted inFIG. 180 . -
FIGS. 182 a-182 c depict schematic views of an insertion tip of the main body insertion instrument of one embodiment of this invention as shown inFIGS. 180 and 181 . -
FIG. 182 a depicts a side view of the insertion tip of a main body insertion instrument of one embodiment of this invention with a locking pin and spacer engagement pin spacer in the extended position. -
FIG. 182 b depicts the insertion tip as shown inFIG. 182 a with a locking pin and spacer engagement pin spacer in a retracted position. -
FIG. 182 c depicts a top view of the insertion tip of the main body insertion instrument of one embodiment of this invention with the locking pin and engagement pin spacer in a retracted position. -
FIG. 183 a depicts an embodiment of a main body assembly of a spinal implant of the invention used with a main body insertion instrument of this invention. -
FIGS. 183 b depicts an embodiment of a main body insertion instrument of this invention and an embodiment of a main body assembly of the invention as shown inFIG. 183 a, showing the points of engagement between the assembly and the instrument. -
FIG. 183 c depicts an embodiment of a main body assembly of the invention and an embodiment of a main body insertion instrument of the invention, both depicted inFIG. 183 b, engaged with one another. -
FIG. 184 depicts an exterior view of an embodiment of a wing insertion instrument of the invention. -
FIG. 185 depicts a schematic, sectioned, longitudinal view of the embodiment of a wing insertion instrument of the invention as shown inFIG. 184 -
FIG. 186 a depicts an end view of an embodiment of an insertion tip of a wing insertion instrument of the invention are depicted inFIGS. 184 and 185 . -
FIG. 186 b depicts a top view of an embodiment of an insertion tip of a wing insertion instrument of the invention as depicted inFIG. 186 a with a driver in a distal position. -
FIG. 186 c depicts a top view of the embodiment of the insertion tip of a wing insertion instrument of the invention as depicted inFIGS. 186 a and 186 b with the driver in a proximal position. -
FIG. 187 a depicts a side view of an embodiment of a universal wing of the invention which is implantable with a wing insertion instrument of the invention. -
FIG. 187 b depicts an end view of an embodiment of a universal wing of the invention are depicted inFIG. 187 a without an attachment bolt. -
FIG. 187 c depicts the embodiment of an embodiment of the universal wing of the invention as shown inFIG. 187 b with an attachment bolt. -
FIGS. 188 a-188 c depict an embodiment of an insertion tip of a wing insertion instrument of the invention as shown inFIG. 185 and 186, and an embodiment of a universal wing of the invention. More particularly,FIGS. 188 a-188 c depict the following. -
FIG. 188 a is a side view showing the relationships of an embodiment a universal wing of the invention and an embodiment of a wing insertion instrument of the invention, showing the points of engagement. -
FIG. 188 b is a side view of the embodiment of the universal wing and the wing insertion instrument of the invention depicted inFIG. 188 a after engagement. -
FIG. 188 c is a top view of the embodiment of a universal wing and a wing insertion instrument of the invention as depicted inFIG. 188 b. -
FIGS. 189 a-189 d depict trial implantation and distraction instruments of the invention. -
FIGS. 190 a and 190 b depict the insertion of a main body assembly of the invention into the spine of a patient. More particularly,FIGS. 190 a and 190 b depict the following. -
FIG. 190 a depicts a lateral view of a spine, and an embodiment of a main body insertion instrument of the invention engaged with an embodiment of a main body assembly of the invention positioned between spinous processes of adjacent vertebrae of a patient. -
FIG. 190 b depicts a dorsal view of a spine of a patient depicting an embodiment of a main body assembly of the invention inserted between spinal processes of adjacent vertebrae. -
FIG. 191 depicts a lateral view of a spine with an embodiment of a main body assembly of the invention inserted between spinous processes of adjacent vertebrae and a wing implant insertion instrument of the invention engaged with an embodiment of a universal wing of the invention, showing the points of attachment between the embodiment of the main body assembly and the universal wing of the invention. -
FIG. 192 depicts a dorsal view of a spine with an embodiment of a main body assembly of the invention inserted between spinous processes of adjacent vertebrae, and showing the insertion of an embodiment of a universal wing of the invention and its attachment to the embodiment of main body assembly of the invention. -
FIG. 193 depicts an alternative embodiment of instruments of the present invention with the handle of the main body insertion instrument nested into an alternate embodiment of the wing insertion instrument of the invention. -
FIG. 194 depicts the wing insertion instrument ofFIG. 193 . -
FIG. 195 depicts an alternative embodiment of the main body insertion instrument. -
FIG. 196 depicts the alternative embodiment of the main body insertion instrument ofFIG. 195 nested into the wing insertion instrument ofFIG. 194 . - A first embodiment of the invention is shown in
FIGS. 1-5 a, 5 b.Implant 20 includes first and second forked ends 22 and 24, each defining asaddle interbody piece 30. As can be seen inFIGS. 3 a, 3 b, the first forkedend 22 includes a threadedshaft 32 which projects rearwardly from thesaddle 26. The threadedshaft 32 fits into the threaded bore 34 (FIG. 4 a) of theinterbody piece 30. - The second forked end 24 (
FIGS. 5 a, 5 b) includes a smoothcylindrical shaft 36 which can fit into thesmooth bore 38 of theinterbody piece 30. -
FIG. 1 shows theimplant 20 in a fully extended position, whileFIG. 2 shows the implant in an unextended position. In the unextended position, it can be seen that the threadedshaft 32 of the first forkedend 22 fits inside the hollowcylindrical shaft 36 of the second forkedend 24. - For purposes of implantation between adjacent first and second spinous processes of the spinal column, the
implant 20 is configured as shown inFIG. 2 . The first and second spinous processes are exposed using appropriate surgical techniques and thereafter, theimplant 20 is positioned so thatsaddle 26 engages the first spinous process, and saddle 28 engages the second spinous process. At this point, theinterbody piece 30 can be rotated by placing an appropriate tool or pin into the cross holes 40 and upon rotation, thesaddle 26 is moved relative to thesaddle 28. Such rotation spreads apart or distracts the spinous processes with the resultant and beneficial effect of enlarging the volume of the spinal canal in order to alleviate any restrictions on blood vessels and nerves. - It is noted that this implant as well as the several other implants described herein act as an extension stop. That means that as the back is bent backwardly and thereby placed in extension the spacing between adjacent spinous processes cannot be reduced to a distance less than the distance between the lowest point of
saddle 26 and the lowest point ofsaddle 28. This implant, however, does not inhibit or in any way limit the flexion of the spinal column, wherein the spinal column is bent forward. - Preferably, such a device provides for distraction in the range of about 5 mm to about 15 mm. However, devices which can distract up to and above 22 mm may be used depending on the characteristics of the individual patient.
- With all the ligaments (such as the supraspinous ligament) and tissues associated with the spinous processes left intact, the
implant 20 can be implanted essentially floating in position in order to gain the benefits of the aforementioned extension stop and flexion non-inhibitor. If desired, one of thesaddles 26 can be laterally pinned withpin 29 to one of the spinous processes and the other saddle can be loosely associated with the other spinous processes by using atether 31 which either pierces or surrounds the other spinous process and then is attached to the saddle in order to position the saddle relative to the spinous process. Alternatively, both saddles can be loosely tethered to the adjacent spinous process in order to allow the saddles to move relative to the spinous processes. - The shape of the saddles, being concave, gives the advantage of distributing the forces between the saddle and the respective spinous process. This ensures that the bone is not resorbed due to the placement of the
implant 20 and that the structural integrity of the bone is maintained. - The
implant 20 in this embodiment can be made of a number of materials, including but not limited to, stainless steel, titanium, ceramics, plastics, elastics, composite materials or any combination of the above. In addition, the modulus of elasticity of the implant can be matched to that of bone, so that theimplant 20 is not too rigid. The flexibility of the implant can further be enhanced by providing additional apertures or perforations throughout the implant in addition to theholes 40 which also have the above stated purpose of allowing theinterbody piece 30 to be rotated in order to expand the distance between thesaddle - In the present embodiment, it is understood that the spinous processes can be accessed and distracted initially using appropriate instrumentation, and that the
implant 20 can be inserted and adjusted in order to maintain and achieve the desired distraction. Alternatively, the spinous process can be accessed and theimplant 20 appropriately positioned. Once positioned, the length of the implant can be adjusted in order to distract the spinous processes or extend the distraction of already distracted spinous processes. Thus, the implant can be used to create a distraction or to maintain a distraction which has already been created. - The placement of implants such as
implant 20 relative to the spinous process will be discussed herein with other embodiments. However, it is to be noted that ideally, theimplant 20 would be placed close to the instantaneous axis of rotation of the spinal column so that the forces placed on theimplant 20 and the forces that theimplant 20 places on the spinal column are minimized. - Further, it is noted that during the actual process of installing or implanting the
implant 20, that the method uses the approach of extending the length of the implant 20 a first amount and then allowing the spine to creep or adjust to this distraction. Thereafter,implant 20 would be lengthened another amount, followed by a period where the spine is allowed to creep or adjust to this new level of distraction. This process could be repeated until the desired amount of distraction has been accomplished. This same method can be used with insertion tools prior to the installation of an implant. The tools can be used to obtain the desired distraction using a series of spinal distraction and spine creep periods before an implant is installed. - The embodiment of the invention shown in the above
FIGS. 6, 7 , 8, 9 and 10 includes distraction orspreader tool 50 which has first andsecond arms Arms pivot point 56 and releaseable frompivot point 56 in order to effect the implantation ofimplant 58. As can be seen inFIG. 6 , in cross-section, thearms spinous process 60 relative toarm 52 and the secondspinous process 62 relative toarm 54. Thedistraction tool 50 can be inserted through a small incision in the back of the patient in order to address the space between the firstspinous process 60 and the secondspinous process 62. Once thetool 50 is appropriately positioned, thearms implant 58 as shown inFIGS. 8 and 9 , or of a design shown in other of the embodiments of this invention, can be urged between thearms arms implant 58 in place. Theimplant 58 is urged into place using atool 64 which can be secured to theimplant 58 through a threadedbore 66 in the back of the implant. As can be seen inFIG. 10 , theimplant 58 includessaddles 68 and 70 which cradle the upper and lowerspinous processes tool 50. The saddles as described above tend to distribute the load between the implant and the spinous processes and also assure that the spinous process is stably seated at the lowest point of the respective saddles. - Another embodiment of the apparatus and method of the invention is shown in
FIGS. 11, 12 and 13. In this embodiment, the spreader ordistraction tool 80 includes first andsecond arms pivot point 86. The arms include L-shaped ends 88, 90. Through a small incision, the L-shaped ends 88, 90 can be inserted between the first and second spinous processes 92, 94. Once positioned, thearms implant 96 can then be urged between the spinous processes in order to maintain the distraction. It is noted thatimplant 96 includes wedged surfaces orramps implant 96 is being urged between the spinous processes, the ramps further cause the spinous processes to be distracted. Once theimplant 96 is fully implanted, the full distraction is maintained by theplanar surfaces implant 96 can be similar to that shown forimplant 58 or similar to other implants in order to gain the advantages of load distribution and stability. - In
FIGS. 14 and 15 , yet another embodiment of the invention is depicted. In this embodiment, theimplant 110 includes first and second conically shapedmembers Member 112 includes amale snap connector 116 andmember 114 includes afemale snap connector 118. Withmale snap connector 116 urged intofemale snap connector 118, thefirst member 112 is locked to thesecond member 114. In this embodiment, a distraction orspreader tool 80 could be used. Once the spinous process has been spread apart, animplantation tool 120 can be used to position and snap together theimplant 110. Thefirst member 112 ofimplant 110 is mounted on one arm andsecond member 114 is mounted on the other arm oftool 120. Themember members implant 110 is locked in place between the spinous processes as shown inFIG. 15 . It is to be noted that theimplant 110 can also be made more self-distracting by causing thecylindrical surface 122 to be more conical, much assurface 124 is conical, in order to holdimplant 110 in place relative to the spinous processes and also to create additional distraction. - An alternative embodiment of the implant can be seen in
FIGS. 16 and 17 . Thisimplant 130 includes first andsecond members bore 136 and engages a threadedbore 138 of thesecond member 134.Surfaces 139 are flattened (FIG. 17 ) in order to carry and spread the load applied thereto by the spinous processes. - The embodiment of
implant 130 is not circular in overall outside appearance, as is theembodiment 110 ofFIGS. 14 and 15 . In particular, with respect to the embodiment ofimplant 130 ofFIGS. 16 and 17 , this embodiment is truncated so that thelateral side lower sides 144, 146 being elongated in order to capture and create a saddle for the upper and lower spinous processes. The upper and lower sides, 144, 146 are rounded to provide a more anatomical implant which is compatible with the spinous processes. - If it is desired, and in order to assure that the
first member 132 and thesecond member 134 are aligned, key 148 andkeyway 150 are designed to mate in a particular manner.Key 148 includes at least one flattened surface, such as flattenedsurface 152, which mates to an appropriately flattenedsurface 154 of thekeyway 150. In this manner, the first member is appropriately mated to the second member in order to form appropriate upper and lower saddles holding theimplant 130 relative to the upper and lower spinous processes. -
FIG. 16 a depictssecond member 134 in combination with a rounded nose lead-inplug 135. Lead-inplug 135 includes abore 137 which can fit snugly overkey 148. In this configuration, the lead-inplug 135 can be used to assist in the placement of thesecond member 134 between spinous processes. Once thesecond member 134 is appropriately positioned, the lead-inplug 135 can be removed. It is to be understood that the lead-inplug 135 can have other shapes such as pyramids and cones to assist in urging apart the spinous processes and soft tissues in order to position thesecond member 134. Embodiment ofFIGS. 18, 19 and 20 - The
implant 330 as shown inFIG. 18 is comprised of first andsecond mating wedges wedges implant 330 located between the upper and lowerspinous processes 336, 338 (FIG. 20 ), increases, thereby distracting the spinous processes. It is noted that thewedges saddle spinous processes - The first or
second wedges channel 344 and a projection of 346 which can be urged into the channel in order to lock thewedges channel 334 is undercut in order to keep the projection from separating therefrom. Further, as in other devices described herein, a detent can be located in one of the channel and the projection, with a complimentary recess in the other of the channel and the projection. Once these two snap together, the wedges are prevented from sliding relative to the other in thechannel 344. - While the above embodiment was described with respect to wedges, the wedges could also have been designed substantially as cones with all the same features and advantages.
- The
implant 370 is comprised of first andsecond distraction cone spinous processes FIG. 21 . Using appropriate tool as shown hereinabove, thedistraction cones FIG. 22 . Once this has occurred, an appropriate screw or other type offastening mechanism 380 can be used to maintain the position of thedistraction cones implant 370 is self-distracting and also that the implant, being flexible, molds about the spinous processes as shown inFIG. 22 . - In
FIGS. 23 and 24 , another embodiment of theimplant 170 is depicted. This implant is guided in place using an L-shapedguide 172 which can have a concave cross-section such as thecross-section 52 ofretraction tool 50 inFIG. 6 in order to cradle and guide theimplant 170 in position. Preferably a small incision would be made into the back of the patient and the L-shapedguide tool 172 inserted between the adjacent spinous processes. Theimplant 170 would be mounted on the end ofinsertion tool 174 and urged into position between the spinous processes. The act of urging the implant into position could cause the spinous processes to be further distracted if that is required. Prior to the insertion of the L-shapedguide tool 172, a distraction tool such as shown inFIG. 13 could be used to initially distract the spinous processes. -
Implant 170 can be made of a deformable material so that it can be urged into place and so that it can somewhat conform to the shape of the upper and lower spinous processes. This deformable material would be preferably an elastic material. The advantage of such a material would be that the load forces between the implant and the spinous processes would be distributed over a much broader surface area. Further, the implant would mold itself to an irregular spinous process shape in order to locate the implant relative to spinous processes. - With respect to
FIG. 25 , thisimplant 176 can be inserted over a guide wire, guide tool orstylet 178. Initially, theguide wire 178 is positioned through a small incision to the back of the patient to a position between the adjacent spinous processes. After this has occurred, the implant is threaded over theguide wire 178 and urged into position between the spinous processes. This urging can further distract the spinous processes if further distraction is required. Once the implant is in place, theguide tool 178 is removed and the incision closed. The insertion tools ofFIGS. 23 and 24 can also be used if desired. - The embodiment shown in
FIGS. 26, 27 and 28 uses an implant similar to that depicted inFIGS. 8 and 9 with different insertion tools. As can be seen inFIG. 26 , an L-shapeddistraction tool 190 is similar to L-shaped distraction tool 80 (FIG. 12 ), is used to distract the first and secondspinous processes insertion tool 196 is placed between thespinous processes Insertion tool 196 includes ahandle 198 to which is mounted a square-shapedring 200. - The
distraction tool 190 can be inserted through a small incision in the back in order to spread apart the spinous processes. Through the same incision which has been slightly enlarged laterally, anupper end 202 ofring 200 can be initially inserted followed by the remainder of thering 200. Once the ring is inserted, the ring can be rotated slightly by movinghandle 198 downwardly in order to further wedge the spinous processes apart. Once this has been accomplished, an implant such asimplant 204 can be inserted through the ring and properly positioned usingimplant handle 206. Thereafter, theimplant handle 206 and theinsertion tool 196 can be removed. - As can be seen in
FIGS. 29 and 30 , theimplants FIG. 8 ) and 204 (FIG. 28 ). These implants have cross-sections similar to that shown inFIG. 10 which includes saddles in order to receive and hold the adjacent spinous processes. - As can be seen in
FIGS. 31, 32 and 33, these implants can be placed in different positions with respect to thespinous process 214. Preferably as shown inFIG. 33 , theimplant 210 is placed closest to thelamina 216. Being so positioned, theimplant 210 is close to the instantaneous axis ofrotation 218 of the spinal column, and the implant would experience least forces caused by movement of the spine. Thus, theoretically, this is the optimal location for the implant. - As can be seen in
FIGS. 31 and 32 , the implant can be placed midway along the spinous process (FIG. 32 ) and towards the posterior aspect of the spinous process (FIG. 31 ). As positioned shown inFIG. 31 , the greatest force would be placed on theimplant 210 due to a combination of compression and extension of the spinal column. - Another embodiment of the invention is shown in
FIGS. 34 and 35 . In these figures,implant 220 is comprised of a plurality ofindividual leaves 222 which are substantially V-shaped. The leaves include interlocking indentations ordetents 224. That is, each leaf includes an indentation with a corresponding protrusion such that a protrusion of one leaf mates with an indentation of an adjacent leaf. Also associated with this embodiment is aninsertion tool 226 which has ablunt end 228 which conforms to the shape of anindividual leaf 222. For insertion of this implant into the space between the spinous processes as shown inFIG. 29 , theinsertion tool 226 first insert asingle leaf 220. After that has occurred, the insertion tool then inserts a second leaf with theprotrusion 224 of the second leaf snapping into corresponding indentation made by theprotrusion 224 of the first leaf. This process would reoccur with third and subsequent leaves until the appropriate spacing between the spinous processes was built up. As can be seen inFIG. 29 , thelateral edges 229 of the individual leaves 222 are slightly curved upwardly in order to form a saddle for receiving the upper and lower spinous processes. - The embodiments of
FIGS. 36, 37 and 38 which includeimplants Implant 220 is essentially a series of truncated cones and includes a plurality of ever expandingsteps 236. These steps are formed by the conical bodies starting with thenose body 238 followed there behind byconical body 240. Essentially, theimplant 234 looks like a fir tree placed on its side. - The
implant 230 is inserted laterally throughout the opening between upper and lower spinous processes. Thefirst body 238 causes the initial distraction. Each successive conical body distracts the spinous processes a further incremental amount. When the desired distraction has been reached, the spinous processes are locked into position bysteps 236. At this point, if desired, theinitial nose body 238 of the implant andother bodies 240 can be broken, snapped or sawed off if desired in order to minimize the size of theimplant 230. In order for a portion of theimplant 230 to be broken or snapped off, the intersection between bodies such asbody intersection line 242, would be somewhat weaken with the appropriate removal of material. It is noted that only the intersection lines of the initial conical bodies need to be so weakened. Thus,intersection line 244 between the bodies which remain between the spinous processes would not need to be weaker, as there would be no intention that the implant would be broken off at this point. -
FIG. 37 shows implant 232 positioned between upper and lower spinous processes. This implant is wedge-shaped or triangular shaped in cross-sectioned and includes borepluralities pins pins bore pluralities pins surface - Turning to
FIG. 38 , theimplant 234 has a triangular-shaped or wedge-shaped body similar to that shown inFIG. 32 . In this embodiment,tab 252, 254 are pivotally mounted to the triangularshaped body 234. Once theimplant 234 is appropriately positioned in order to distract the spinous processes to the desired amount, thetabs 252, 254 rotate into position in order to hold theimplant 234 in the appropriate position. - In the embodiment of
FIGS. 39 and 40 ,cannula 258 is inserted through a small incision to a position between upper and lower spinous processes. Once the cannula is properly inserted, animplant 260 is pushed through thecannula 258 using aninsertion tool 262. Theimplant 260 includes a plurality of ribs orindentation 264 that assist in positioning theimplant 260 relative to the upper and lower spinal processes. Once theimplant 260 is in position, thecannula 258 is withdrawn so that theimplant 260 comes in contact with and wedges between the spinous processes. Thecannula 258 is somewhat conical in shape with thenose end 266 being somewhat smaller than thedistal end 268 in order to effect the insertion of the cannula into the space between the spinous processes. - Further, a plurality of cannula can be used instead of one, with each cannula being slightly bigger than one before. In the method of the invention, the first smaller cannula would be inserted followed by successively larger cannula being placed over the previous smaller cannula. The smaller cannula would then be withdrawn from the center of the larger cannula. Once the largest cannula is in place, and the opening of the skin accordingly expanded, the implant, which is accommodated by only the larger cannula, is inserted through the larger cannula and into position.
- The
precurved implant 270 inFIGS. 41 and 42 , andprecurved implant 272 inFIG. 43 have common introduction techniques which includes a guide wire, guide tool, orstylet 274. For both embodiments, theguide wire 274 is appropriately positioned through the skin of the patient and into the space between the spinous processes. After this is accomplished, the implant is directed over the guide wire and into position between the spinous processes. The precurved nature of the implant assist in (1) positioning the implant through a first small incision in the patient's skin on one side of the space between two spinous processes and (2) guiding the implant toward a second small incision in the patient's skin on the other side of the space between the two spinous processes. With respect to theimplant 270, the implant includes aconical introduction nose 276 and adistal portion 278. As thenose 276 is inserted between the spinous processes, this causes distraction of the spinous processes.Break lines implant 270. Once the implant is properly positioned over the guide wire between the spinous processes, thenose portion 276 and thedistal portion 278 can be broken off along the break lines, through the above two incisions, in order to leave theimplant 270 in position. - Although only two
break lines implant 270 so that the implant can continue to be fed over theguide wire 278 until the appropriate width of theimplant 270 creates the desired amount of distraction. As described hereinabove, the break lines can be created by perforating or otherwise weakening theimplant 270 so that the appropriate portions can be snapped or sawed off. - With respect to the
precurved implant 272, this implant is similar in design to theimplant 230 shown inFIG. 36 . Thisimplant 272 inFIG. 47 , however, is precurved and inserted over aguide wire 274 to a position between the spinous processes. As withimplant 230 inFIG. 43 , once the appropriate level of this distraction has been reached and if desired, sections of theimplant 272 can be broken, snapped or sawed off as described hereinabove in order to leave a portion of the implant wedged between the upper and lower spinous processes. - A further embodiment of the invention is shown in
FIG. 44 . This embodiment includes a combination insertion tool andimplant 290. The insertion tool andimplant 290 is in the shape of a ring which is hinged atpoint 292. The ring is formed by a first elongated and conically shapedmember 294 and a second elongated and conically shapedmember 296.Members hinge 292 are aligned and meet. Through similar incisions on both sides of the spinous processes, first member and second member are inserted through the skins of the patient and are mated together between the spinous processes. After this has occurred, theimplant 290 is rotated, for example clockwise, so that increasingly widening portions of thefirst member 292 are used to distract the first and second spinous processes. When the appropriate level of distraction has occurred, the remainder of the ring before and after the section which is located between the spinous processes can be broken off as taught hereinabove in order to maintain the desired distraction. Alternatively, with a small enough ring, the entire ring can be left in place with the spinous processes distracted. - In
FIG. 45 , theimplant 300 is comprised of a plurality of rods orstylets 302 which are inserted between the upper and lower spinous processes. The rods are designed much as described hereinabove so that they may be broken, snapped or cut off. Once these are inserted and the appropriate distraction has been reached, the stylets are broken off and a segment of each stylet remains in order to maintain distraction of the spinous process. -
Implant 310 ofFIGS. 46 and 47 is comprised of a shape memory material which coils upon being released. The material is straightened out in adelivery tool 312. The delivery tool is in position between upper and lowerspinous processes delivery end 318 of the delivery tool, the material coils, distracting the spinous processes to the desired amount. Once this distraction has been achieved, the material is cut and the delivery tool removed. - As can be seen in
FIG. 48 , theimplant 320 is delivered between upper and lowerspinous processes delivery tool 326. Once theimplant 320 is in place between the spinous processes, the delivery tool is given a 90° twist so that the implant goes from the orientation as shown inFIG. 49 , with longest dimension substantially perpendicular to the spinous processes, to the orientation shown inFIG. 50 where the longest dimension is in line with and parallel to the spinous processes. This rotation causes the desired distraction between the spinous processes.Implant 320 includes opposedrecesses implant 320 causes the spinous processes to become lodged in these recesses. - Alternatively, the
insertion tool 326 can be used to insertmultiple implants spinous processes 322, 324 (FIG. 51 ).Multiple implants - The embodiment of
FIGS. 52 through 55 b is comprised of a fluid-filleddynamic distraction implant 350. This implant includes amembrane 352 which is placed overpre-bent insertion rod 354 and then inserted through an incision on one side of thespinous process 356. The bent insertion rod, with theimplant 350 thereover, is guided between appropriate spinous processes. After this occurs, theinsertion rod 354 is removed leaving the flexible implant in place. Theimplant 350 is then connected to a source of fluid (gas, liquid, gel and the like) and the fluid is forced into the implant causing it to expand as shown inFIG. 54 , distracting the spinal processes to the desired amount. Once the desired amount of distraction has occurred, theimplant 350 is closed off as is shown inFIG. 55 a. Theimplant 350 being flexible, can mold to the spinous processes which may be of irregular shape, thus assuring positioning. Further, implant 350 acts as a shock absorber, damping forces and stresses between the implant and the spinous processes. - A variety of materials can be used to make the implant and the fluid which is forced into the implant. By way of example only, viscoelastic substances such as methylcellulose, or hyaluronic acid can be used to fill the implant. Further, materials which are initially a fluid, but later solidify, can be inserted in order to cause the necessary distraction. As the materials solidify, they mold into a custom shape about the spinous processes and accordingly are held in position at least with respect to one of two adjacent spinous processes. Thus, it can be appreciated that using this embodiment and appropriate insertion tools the implant can be formed about one spinous process in such a manner that the implant stays positioned with respect to that spinous process (
FIG. 55 b). With such an embodiment, a single implant can be used as an extension stop for spinous process located on either side, without restricting flexion of the spinal column. - It is to be understood that many of the other implants disclosed herein can be modified so that they receive a fluid in order to establish and maintain a desired distraction much in the manner as
implant 350 receives a fluid. - The
implant 360 as shown inFIG. 56 is comprised of a shape memory material such as a plastic or a metal. A curvedintroductory tool 362 is positioned between the appropriate spinous processes as described hereinabove. Once this has occurred, bore 364 of the implant is received over the tool. This act can cause the implant to straighten out. The implant is then urged into position and thereby distracts the spinous processes. When this has occurred, theinsertion tool 362 is removed, allowing the implant to assume its pre-straightened configuration and is thereby secured about one of the spinous processes. Such an arrangement allows for an implant that is an extension stop and does not inhibit flexion of the spinous column. Alternatively, the implant can be temperature sensitive. That is to say that the implant would be more straightened initially, but become more curved when it was warmed by the temperature of the patient's body. - In this embodiment, the
implant 380 is comprised of a plurality of interlocking leaves 382. Initially, a first leaf is positioned between opposedspinous processes leafs 382 are interposed between the spinous processes until the desired distraction has been built up. The leaves are somewhat spring-like in order to absorb the shock and can somewhat conform to the spinous processes. - The
implant 390 ofFIG. 61 includes the placement ofshields spinous processes screw rod 404 is used to hold the distracted position by being screwed into each of the spinous processes through the aperture in the shields using the screws as depicted inFIG. 61 . -
Implant 410 ofFIGS. 62, 63 is comprised of first andsecond members implant 410.Main member 412 andmating member 414form implant 410. Accordingly, theimplant 410 would have a plurality ofmembers 414 for use with a standardizedfirst member 412.FIGS. 62 and 64 show different types ofmating members 414. InFIG. 62 , themating member 414 includesprojections saddles first member 412. Theseprojections groove 424 is placed between theprojections extension 426 of thefirst member 412. - As shown in
FIG. 63 , the projections of the embodiment shown inFIG. 62 are removed and recesses 428, 430 are substituted therefor. These recesses expand the area of thesaddles - The embodiments of
FIGS. 64, 65 and 66 are similar in design and concept to the embodiment ofFIGS. 62 and 63 . InFIG. 64 , theimplant 500 includes the first andsecond members Implant 500 includes first andsecond saddles second members saddles FIG. 64 , eachsaddle leg second members FIGS. 62 and 63 , each of the saddles is defined by only a single leg as the ligaments and other tissues associated with the spinous processes can be used to ensure that the implant is held in an appropriate position. With the configuration ofFIG. 64 , it is easier to position the implant relative to the spinous processes as each saddle is defined by only a single leg and thus the first and second members can be more easily worked into position between the various tissues. - In the embodiment of
FIG. 65 , theimplant 520 is comprised of a singlepiece having saddles single leg implant 520 to be positioned between the spinous processes, an incision is made between lateral sides of adjacent spinous processes. Thesingle leg 526 is directed through the incision to a position adjacent to an opposite lateral side of the spinous process with the spinous process cradled in thesaddle 522. The spinous processes are then urged apart untilsaddle 524 can be pivoted into position into engagement with the other spinous process in order to maintain the distraction between the two adjacent spinous processes. - The embodiment of
FIG. 66 is similar to that ofFIG. 65 with animplant 530 and first andsecond saddles tether implant 530. Once appropriately positioned, the tethers can be tied off. It is to be understood that the tethers are not meant to be used to immobilize one spinous process relative to the other, but are used to guide motion of the spinous processes relative to each other so that theimplant 530 can be used as an extension stop and a flexion non-inhibitor. In other words, thesaddles - The
implant 550 is Z-shaped and includes acentral body 552 and first andsecond arms central body 552 of theimplant 550 includes first andsecond saddles second saddles spinous processes arms FIG. 68 ) of thecentral body 552. The first andsecond arms implant 550 toward the spinal canal and keep the implant in place relative to the first and second spinal processes. This prevents the implant from pressing down on the ligamentum flavum and the dura. In a preferred embodiment, the central body would have a height of about 10 mm with each of thearms FIGS. 67 and 68 , the first andsecond arms spinous processes arms arm 554 have a slightly outwardly bowed portion 568 (FIG. 68 ) with adistal end 570 which is slightly inwardly bowed. This configuration allows the arm to fit about the spinous process with thedistal end 570 somewhat urged against the spinous process in order to guide the motion of the spinous process relative to the implant. Thesearms central body 552 by makingarms central body 550. As with the last embodiment, this embodiment can be urged into position between adjacent spinous processes by directing an arm into a lateral incision so that thecentral body 552 can be finally positioned between spinous processes. -
FIGS. 69, 70 and 71 are perspective front, end, and side views ofimplant 580 of the invention. This implant includes acentral body 582 which has first andsecond saddles implant 580 includes first andsecond arms First arm 588 projects outwardly from thefirst saddle 584 andsecond arm 590 projects outwardly from thesecond saddle 586. In a preferred embodiment, thefirst arm 588 is located adjacent to thedistal end 600 of thecentral body 582 and proceeds only partly along the length of thecentral body 582. Thefirst arm 588 is substantially perpendicular to the central body as shown inFIG. 70 . Further, thefirst arm 588, as well as thesecond arm 590, is anatomically rounded. - The
second arm 590, projecting fromsecond saddle 586, is located somewhat rearward of thedistal end 600, and extends partially along the length of thecentral body 582. Thesecond arm 590 projects at a compound angle from thecentral body 582. As can be seen inFIGS. 70 and 71 , thesecond arm 590 is shown to be at about an angle of 45° from the saddle 586 (FIG. 70 ). Additionally, thesecond arm 590 is at an angle of about 45° relative to the length of thecentral body 580 as shown inFIG. 71 . It is to be understood that other compound angles are within the spirit and scope of the invention as claimed. - In a preferred embodiment, the first and
second arms central body 582. Preferably, the length of each arm is about 10 mm and the width of the central body is about 10 mm. However, the bodies with the widths of 24 mm and greater are within the spirit and scope of the invention, along with first and second arms ranging from about 10 mm to greater than about 24 mm. Further, it is contemplated that the embodiment could include a central body having a width of about or greater than 24 mm with arms being at about 10 mm. - It is to be understood that the embodiment of
FIGS. 69, 70 and 71 as well as the embodiment ofFIGS. 67 and 68 are designed to preferably be positioned between the L4-L5 and the L5-S1 vertebral pairs. The embodiment ofFIGS. 69, 70 , 71 is particularly designed for the L5-S1 position with the arms being designed to conform to the sloping surfaces found therebetween. The first and second arms are thus contoured so that they lie flat against the lamina of the vertebra which has a slight angle. - The embodiment of
FIGS. 69, 70 , and 71 as with the embodiment ofFIGS. 67 and 68 is Z-shaped in configuration so that it may be inserted from one lateral side to a position between adjacent spinous processes. A first arm, followed by the central body, is guided through the space between the spinous processes. Such an arrangement only requires that a incision on one side of the spinous process be made in order to successfully implant the device between the two spinous processes. - The
implant 610 ofFIG. 71 a is similar to that immediately above with thefirst arm 612 located on the same side of the implant as thesecond arm 614. The first andsecond saddle distal portion -
Implant 630 is also designed so that it can be inserted from one side of adjacent spinous processes. Thisinsert 630 includes acentral body 632 with the first andsecond arms FIG. 72 , aplunger 638 is positioned to extend from an end of thecentral body 632. As shown inFIG. 72 , theplunger 638 is fully extended and as shown inFIG. 73 , theplunger 638 is received within thecentral body 632 of theimplant 630. With the plunger received into theimplant 632, the third and fourth arms or hooks 640, 642 can extend outwardly from thecentral body 632. The third and fourth arms or hooks 640, 642 can be comprised of a variety of materials, such as for example, shape memory metal materials or materials which have a springy quality. - For purposes of positioning the
implant 630 between adjacent spinous processes, theplunger 638 is pulled outwardly as shown inFIG. 72 . Thecentral body 632 is then positioned between adjacent spinous processes and theplunger 638 is allowed to move to the position ofFIG. 73 so that the third andfourth arms central body 632 in order to hold theimplant 630 in position between the spinous processes. -
Plunger 638 can be spring biased to the position as shown inFIG. 73 or can include detents or other mechanisms which lock it into that position. Further, the third and fourth arms themselves, as deployed, can keep the plunger in the position as shown inFIG. 73 . - Other embodiments of the invention are shown in
FIGS. 74 through 78 .FIGS. 74, 75 and 76disclose implant 700.Implant 700 is particularly suited for implantation between the L4-L5 and L5-S1 vertebra. As can be seen inFIG. 74 , theimplant 700 includes acentral body 702 which has abore 704 provided therein.Bore 704 is used in order to adjust the modulus of elasticity of the implant so that it is preferably approximately two times the anatomical load placed on the vertebra in extension. In other words, theimplant 700 is approximately two times stiffer than the normal load placed on the implant. Such an arrangement is made in order to ensure that the implant is somewhat flexible in order to reduce potential resorption of the bone adjacent to the implant. Other modulus values can be used and be within the spirit of the invention. -
Implant 700 includes first andsecond saddle saddle 706 is defined by first andsecond arms second saddle 708 is defined by third andfourth arms FIG. 74 , thefirst arm 710, in a preferred embodiment, is approximately two times the length of thebody 702 with the second arm being approximately less than a quarter length of the body.Third arm 714 is approximately one times the length of thebody 702 with thefourth arm 716 being, in this preferred embodiment, approximately one and a half times the length of thebody 702. The arms are designed in such a way that the implant (1) can be easily and conveniently inserted between the adjacent spinous processes, (2) will not migrate forwardly toward the spinal canal, and (3) will hold its position through flexion and extension as well as lateral bending of the spinal column. -
First arm 710 is in addition designed to accommodate the shape of the vertebra. As can be seen inFIG. 74 , thefirst arm 710 becomes narrower as it extends away from thebody 702. Thefirst arm 710 includes a slopingportion 718 followed by asmall recess 720 ending in arounded portion 722 adjacent to theend 724. This design is provided to accommodate the anatomical form of for example the L4 vertebra. It is to be understood that these vertebra have a number of surfaces at roughly 30° angles and that the sloping surfaces of this embodiment and the embodiments shown inFIGS. 77 and 78 are designed to accommodate these surfaces. These embodiments can be further modified in order to accommodate other angles and shapes. - The
second arm 712 is small so that it is easy to insert between the spinous processes, yet still define thesaddle 706. Thefourth arm 716 is larger than thethird arm 714, both of which are smaller than thefirst arm 710. The third and fourth arms are designed so that they define thesaddle 706, guide the spinous processes relative to theimplant 700 during movement of the spinal column, and yet are of a size which makes the implant easy to position between the spinous processes. - The procedure, by way of example only, for implanting the
implant 700 can be to make an incision laterally between two spinous processes and then initially insertfirst arm 710 between the spinous processes. The implant and/or appropriate tools would be used to distract the spinous processes allowing thethird leg 714 and thecentral body 702 to fit through the space between the spinous processes. Thethird leg 714 would then come to rest adjacent the lower spinous processes on the opposite side with the spinous processes resting in the first andsecond saddle fourth leg 716 would then assist in the positioning of theimplant 700. -
FIG. 77 includes animplant 740 which is similar toimplant 700 and thus have similar numbering. Thesaddle implant 740 have been cantered or sloped in order to accommodate the bone structure between, by way of example, the L4-L5 and the L5-S1 vertebra. As indicated above, the vertebra in this area have a number of sloping surfaces in the range of about 30°. Accordingly,saddle 706 is sloped at less than 30° and preferably about 20° whilesaddle 708 is sloped at about 30° and preferably more than 30°. - The
implant 760 as shown inFIG. 78 is similar toimplant 700 inFIG. 74 and is similarly numbered.Implant 760 includes third andfourth legs portions fourth arm - Another embodiment of the invention is shown in
FIGS. 79-87 and includes implant 800 (FIG. 86 ).Implant 800 includes adistracting unit 802 which is shown in left side, plan, and right side views ofFIGS. 79, 80 and 81. A perspective view of the distraction unit is shown inFIG. 84 . The distracting unit as can be seen inFIG. 80 includes adistracting body 804, withlongitudinal axis 805, whichbody 804 has agroove 806 and a rounded orbulbous end 808 which assist in the placement of the distracting body between adjacent spinous process so that an appropriate amount of distraction can be accomplished. Extending from thedistracting body 804 is afirst wing 810 which inFIG. 80 is substantially perpendicular to thedistracting body 804. Such wings which are not perpendicular to the body are within the spirit and scope of the invention.First wing 810 includes aupper portion 812 and alower portion 814. The upper portion 810 (FIGS. 79 ) includes arounded end 816 and asmall recess 818. Therounded end 816 and thesmall recess 818 in the preferred embodiment are designed to accommodate the anatomical form or contour of the L4 (for a L4-L5 placement) or L5 (for a L5-S1 placement) superior lamina of the vertebra. It is to be understood that the same shape or variations of this shape can be used to accommodate other lamina of any vertebra. Thelower portion 814 is also rounded in order to accommodate in the preferred embodiment in order to accommodate the vertebrae. The distracting unit further includes a threadedbore 820 which in this embodiment accepts a set screw 822 (FIG. 86 ) in order to hold a second wing 824 (FIGS. 82, 83 ) in position as will be discussed hereinbelow. - The threaded bore 820 in this embodiment slopes at approximately 45° angle and intersects the
slot 806. With thesecond wing 824 in position, theset screw 822 when it is positioned in the threadedbore 820 can engage and hold thesecond wing 824 in position in theslot 806. - Turning to
FIGS. 82, 83 and 85, left side, plan and perspective views of thesecond wing 824 are depicted. Thesecond wing 824 is similar in design to the first wing. The second wing includes anupper portion 826 and alower portion 828. The upper portion includes arounded end 830 and asmall recess 832. In addition, thesecond wing 824 includes aslot 834 which mates with theslot 806 of thedistracting unit 802. Thesecond wing 824 is the retaining unit of the present embodiment. - As can be seen in
FIGS. 83 and 86 , the second wing or retainingunit 824 includes theupper portion 826 having a first width “a” and thelower portion 828 having a second width “b”. In the preferred embodiment, the second width “b” is larger than first width “a” due to the anatomical form or contour of the L4-L5 or L5-S1 laminae. As can be seen inFIG. 83 a in second wing or retainingunit 824, the widths “a” and “b” would be increased in order to, as described hereinbelow, accommodate spinous processes and other anatomical forms or contours which are of different dimensions. Further, as appropriate, width “a” can be larger than width “b”. Thus, as will be described more fully hereinbelow, the implant can include a universally-shapeddistracting unit 802 with a plurality of retainingunits 824, with each of the retaining units having different widths “a” and “b”. During surgery, the appropriatelysized retaining unit 824, width with the appropriate dimensions “a” and “b” can be selected to match to the anatomical form of the patient. -
FIG. 86 depicts an assembledimplant 800 positioned adjacent to upper andlower laminae 836, 838 (which are shown in dotted lines) of the upper and lower vertebrae. Thevertebrae implant 800 as shown inFIG. 86 . Extending upwardly from thevertebrae second wings spinous processes FIG. 86 , and be within the spirit and scope of the invention. - The
implant 800 includes, as assembled, anupper saddle 844 and thelower saddle 846. Theupper saddle 844 has an upper width identified by the dimension “UW”. Thelower saddle 846 has a lower width identified by the dimension “LW”. In a preferred embodiment, the upper width is greater than the lower width. In other embodiments, the “UW” can be smaller than the “LW” depending on the anatomical requirements. The height between the upper andlower saddles FIG. 87 which is a schematic representation of the substantially trapezoidal shape which is formed between the upper and lower saddles. The table below gives sets of dimensions for the upper width, lower width, and height as shown inFIG. 87 . This table includes dimensions for some variations of this embodiment.Variation 1 2 3 Upper Width 8 7 6 Lower Width 7 6 5 Height 10 9 8 - For the above table, all dimensions are given in millimeters.
- For purposes of surgical implantation of the
implant 800 into a patient, the patient is preferably positioned on his side (arrow 841 points up from an operating table) and placed in a flexed (tucked) position in order to distract the upper and lower vertebrae. - In a preferred procedure, a small incision is made on the midline of the spinous processes. The spinous processes are spread apart or distracted with a spreader. The incision is spread downwardly toward the table, and the
distracting unit 802 is preferably inserted upwardly between thespinous processes distracting unit 802 is urged upwardly until the distracting orbulbous end 808 and theslot 806 are visible on the other wide of the spinous process. Once this is visible, the incision is spread upwardly away from the table and the retaining unit orsecond wing 824 is inserted into theslot 806 and thescrew 822 is used to secure the second wing in position. After this had occurred, the incisions can be closed. - An alternative surgical approach requires that small incisions be made on either side of the space located between the spinous processes. The spinous processes are spread apart or distracted using a spreader placed through the upper incision. From the lower incision, the
distracting unit 802 is preferably inserted upwardly between thespinous processes distracting unit 802 is urged upwardly until the distracting orbulbous end 808 and theslot 806 are visible through the second small incision in the patient's back. Once this is visible, the retaining unit orsecond wing 824 is inserted into theslot 806 and thescrew 822 is used to secure the second wing in position. After this has occurred, the incisions can be closed. - The advantage of either of the above present surgical procedures is that a surgeon is able to observe the entire operation, where he can look directly down onto the spinous processes as opposed to having to view the procedure from positions which are to the right and to the left of the spinous processes. Generally, the incision is as small as possible and the surgeon is working in a bloody and slippery environment. Thus, an implant that can be positioned directly in front of a surgeon is easier to insert and assemble than an implant which requires the surgeon to shift from side to side. Accordingly, a top-down approach, as an approach along a position to anterior line is preferred so that all aspects of the implantation procedure are fully visible to the surgeon at all times. This aides in the efficient location of (i) the distracting unit between the spinous processes, (ii) the retaining unit in the distracting unit, and (iii) finally the set screw in the distracting unit.
-
FIG. 80 a shows an alternative embodiment of thedistracting unit 802 a. Thisdistracting unit 802 a is similar todistracting unit 802 inFIG. 80 with the exception that thebulbous end 808 a is removable from the rest of thedistracting body 804 a as it is screwed into the threadedbore 809. Thebulbous end 808 a is removed once thedistracting unit 802 a is positioned in the patient in accordance with the description associated withFIG. 86 . Thebulbous end 808 a can extend past the threadedbore 820 by about 1 cm in a preferred embodiment. - Another embodiment of the invention is shown in
FIGS. 88, 89 , 90 and 91. In this embodiment, the implant is identified by thenumber 900. Other elements ofimplant 900 which are similar toimplant 800 are similarly numbered but in the 900 series. For example, the distracting unit is identified by thenumber 902 and this is in parallel with thedistracting unit 802 of theimplant 800. The distracting body is identified by thenumber 904 in parallel with thedistracting body 804 of theimplant 800. Focusing onFIG. 90 , thedistracting unit 902 is depicted in a perspective view. The distracting unit includesslot 906 which is wider at the top than at the bottom. The reason for this is that the wider upper portion of theslot 906, which is wider than the second wing 924 (FIG. 89 ), is used to, allow the surgeon to easily place thesecond wing 924 into theslot 906 and allow the wedge-shapedslot 906 to guide thesecond wing 924 to its final resting position. As can be see inFIG. 91 , in the final resting position, the largest portion of theslot 906 is not completely filled by thesecond wing 924. - The
end 908 ofimplant 900 is different in that it is more pointed, havingsides flat tip 913 so that thebody 904 can be more easily urged between the spinous processes. - The
distracting unit 902 further includes a tongue-shapedrecess 919 which extends from theslot 906. Located in the tongue-shaped recess is a threadedbore 920. - As can be seen in
FIG. 89 , asecond wing 924 includes atongue 948 which extends substantially perpendicular thereto and between the upper andlower portions tab 948 includes abore 950. With thesecond wing 924 positioned in theslot 906 of thedistracting unit 902 andtab 948 positioned inrecess 919, a threadedset screw 922 can be positioned through thebore 950 and engage the threaded bore 920 in order to secure the second wing or retainingunit 924 to thedistracting unit 902. Theembodiment 900 is implanted in the same manner asembodiment 800 previously described. In addition, as thebore 922 is substantially perpendicular to the distracting body 904 (and not provided at an acute angle thereto), the surgeon can even more easily secure the screw in place from a position directly behind the spinous processes. - Still a further embodiment of the invention is depicted in
FIGS. 92 , and 92 a. In this embodiment, theimplant 1000 as can be seen inFIG. 92 a includes a centralelongated body 1002 which has positioned at one end thereof afirst wing 1004.Wing 1004 is similar to the first wing previously described with respect to the embodiment ofFIG. 88 .Bolt 1006 secureswing 1004 tobody 1002 in this embodiment.Bolt 1006 is received in a bore of thebody 1002 which is along thelongitudinal axis 1008 of body. It is to be understood that in this embodiment, the first unit is defined by thecentral body 1002, thefirst wing 1004, and theguide 1010. - Alternatively, the first wing can be secured to the central body with a press fit and detent arrangement as seen in
FIG. 93 c. In this arrangement, the first wing has aprotrusion 1040 extending preferably about perpendicularly from the first wing, with aflexible catch 1042. The protrusion and flexible catch are press fit into abore 1044 of the central body with the catch received in adetent 1046. - In yet another alternative embodiment, the first wing can be designed as shown in
FIG. 93 d with the protrusion directed substantially parallel to the first wing from a member that joins the first wing to the protrusion. Thus in this embodiment, the first wing is inserted into the body along the same direction as the second wing is inserted. - Positioned at the other end of the
central body 1002 is aguide 1010. In this particular embodiment,guide 1010 is essentially triangularly-shaped so as to be a pointed and arrow-shaped guide. Alternatively,guide 1010 could be in the shape of a cone with lateral truncated sides along thelongitudinal axis 1008.Guide 1010 includes arecess 1012 having a threadedbore 1014.Recess 1012 is for receiving asecond wing 1032 as will be described hereinbelow. - Additionally, it is also to be understood that the
guide 1010 can be bulbous, cone-shaped, pointed, arrow-shaped, and the like, in order to assist in the insertion of theimplant 1000 between adjacent spinous processes. It is advantageous that the insertion technique disturb as little of the bone and surrounding tissue or ligaments as possible in order to (1) reduce trauma to the site and facilitate early healing, and (2) not destabilize the normal anatomy. It is to be noted that with the present embodiment, there is no requirement to remove any of the bone of the spinous processes and depending on the anatomy of the patient, there may be no requirement to remove or sever ligaments and tissues immediately associated with the spinous processes. - The
implant 1000 further includes asleeve 1016 which fits around and is at least partially spaced from thecentral body 1002. As will be explained in greater detail below, while the implant may be comprised of a bio-compatible material such as titanium, the sleeve is comprised preferably of a super-elastic material which is by way of example only, a nickel titanium material (NiTi), which has properties which allow it to withstand repeated deflection without fatigue, while returning to its original shape. The sleeve could be made of other materials, such as for example titanium, but these materials do not have the advantages of a super-elastic material. -
FIG. 93 a is a cross-section through theimplant 1000 depicting thecentral body 1002 and thesleeve 1016. As can be seen from the cross-section ofFIG. 93 a in a preferred embodiment, both thecentral body 1002 and thesleeve 1016 are substantially cylindrical and oval or ecliptically-shaped. An oval or elliptical shape allows more of the spinous process to be supported by the sleeve, thereby distributing the load between the bone and the sleeve more evenly. This reduces the possibility of fracture to the bone or bone resorption. Additionally, an oval or elliptical shape enhances the flexibility of the sleeve as the major axis of the sleeve, as described below, is parallel to the longitudinal direction of the spinous process. However, other shapes such as round cross-sections can come within the spirit and scope of the invention. - In this particular embodiment, the
central body 1002 includes elongatedgrooves 1018, alongaxis 1008, which receives elongatedspokes 1020 extending from the internal surface of thecylinder 1016. - In a preferred embodiment, both the cross-section of the central body and the sleeve have a major dimension along
axis 1022 and a minor dimensional along axis 1024 (FIG. 93 a). Thespokes 1020 are along the major dimension so that along the minor dimension, thesleeve 1016 can have its maximum inflection relative to thecentral body 1002. It is to be understood that the central body along theminor dimension 1024 can have multiple sizes and can, for example, be reduced in thickness in order to increase the ability of thesleeve 1016 to be deflected in the direction of thecentral body 1002. - Alternatively as can be seen in
FIG. 93 b, thecentral body 1002 can include thespokes 1020 and thesleeve 1016 can be designed to include thegrooves 1018 in order to appropriately space thesleeve 1016 from thecentral body 1002. - In other embodiments, the sleeve can have minor and major dimensions as follows:
Minor Dimension Major Dimension 6 mm 10 mm 8 mm 10.75 mm 12 mm 14 mm 6 mm 12.5 mm 8 mm 12.5 mm 10 mm 12.5 mm - In one preferred embodiment, said sleeve has a cross-section with a major dimension and a minor dimension and said major dimension is greater than said minor dimension and less than about two times said minor dimension. In said embodiment, said guide has a cross-section which is adjacent to said sleeve with a guide major dimension about equal to said sleeve major dimension and a guide minor dimension about equal to said sleeve minor dimension. Further in said embodiment, said guide extends from said central body with a cross-section which reduces in size in a direction away from said central body.
- In another preferred embodiment, said guide is cone-shaped with a base located adjacent to said sleeve. Further, said guide has a base cross-section about the same as the oval cross-section of said sleeve.
- Thus, from the above, it is evident that preferably a major dimension of the sleeve correspond with a major dimension of the central body and a minor dimension of the sleeve corresponds with a minor dimension of the central body. Additionally, it is evident that the major dimension of the
sleeve 1016 is substantially perpendicular to a major dimension of thefirst wing 1004 along longitudinal axis 1030 (FIG. 92 a). This is so that as discussed above, when theimplant 1000 is properly positioned between the spinous processes, a major portion of the sleeve comes in contact with both the upper and lower spinous processes in order to distribute the load of the spinous processes on thesleeve 1016 during spinal column extension. - As indicated above, the preferred material for the
sleeve 1016 is a super-elastic material and more preferably one comprised of an alloy of nickel and titanium. Such materials are available under the trademark Nitinol. Other super-elastic materials can be used as long as they are bio-compatible and have the same general characteristics of super-elastic materials. In this particular embodiment, a preferred super-elastic material is made up of the following composition of nickel, titanium, carbon, and other materials as follows:Nickel 55.80% by weight Titanium 44.07% by weight Carbon <0.5% by weight Oxygen <0.5% by weight - In particular, this composition of materials is able to absorb about 8% recoverable strain. Of course, other materials which can absorb greater and less than 8% can come within the spirit and scope of the invention. This material can be repeatably deflected toward the central body and returned to about its original shape without fatigue. Preferably and additionally, this material can withstand the threshold stress with only a small amount of initial deforming strain and above the threshold stress exhibit substantial and about instantaneous deformation strain which is many times the small amount of initial deforming strain. Such a characteristic is demonstrated in
FIG. 118 where it is shown that above a certain threshold stress level, deformation strain is substantially instantaneous up to about 8%.FIG. 118 shows a loading and unloading curve between stress and deformation strain for a typical type of super-elastic material as described above. - Preferably, the above super-elastic material is selected to allow deformation of up to about, by way of example only, 8%, at about 20 lbs. to 50 lbs. force applied between a spinous processes. This would cause a sleeve to deflect toward the central body absorbing a substantial amount of the force of the spinous processes in extension. Ideally, the sleeves are designed to absorb 20 lbs. to 100 lbs. before exhibiting the super-elastic effect (threshold stress level) described above. Further, it is possible, depending on the application of the sleeve and the anatomy of the spinal column and the pairs of spinous processes for a particular individual, that the sleeve can be designed for a preferable range of 20 lbs. to 500 lbs. of force before the threshold stress level is reached. Experimental results indicate that with spinous processes of an older individual, that at about 400 pounds force, the spinous process may fracture. Further, such experimental results also indicate that with at least 100 pounds force, the spinous process may experience some compression. Accordingly, ideally the super-elastic material is designed to deform or flex at less than 100 pounds force.
- In a preferred embodiment, the wall thickness of the sleeve is about 1 mm or 40/1000 of an inch (0.040 in.). Preferably the sleeve is designed to experience a combined 1 mm deflection. The combined 1 mm deflection means that there is ½ mm of deflection at the top of the minor dimension and a ½ mm deflection at the bottom of the minor dimension. Both deflections are toward the central body.
- In a particular embodiment where the sleeve is more circular in cross-section, with an outer dimension of 0.622 in. and a wall thickness of 0.034 in., a 20 lb. load causes a 0.005 in. deflection and a 60 lb. load causes a 0.020 in. deflection (approximately ½ mm). A 100 lb. load would cause a deflection of about 0.04 in. or approximately 1 mm.
- Thus in summary, the above preferred super-elastic material means that the sleeve can be repeatedly deflected and returned to about its original shape without showing fatigue. The sleeve can withstand a threshold stress with a small amount of deforming strain and at about said threshold stress exhibit about substantially instantaneous deformation strain which is many times the small amount of the forming strain. In other words, such super-elastic qualities mean that the material experiences a plateau stress where the material supports a constant force (stress) over very large strain range as exhibited in
FIG. 118 . - It is to be understood that for this particular embodiment, bar stock of the super-elastic material is machined into the appropriate form and then heat treated to a final temperature to set the shape of the material by increasing the temperature of the material to 932° Fahrenheit and holding that temperature for five (5) minutes and then quickly quenching the sleeve in water. It is also to be understood that preferably the present nickel titanium super-elastic alloy is selected to have a transition temperature Af of about 590 Fahrenheit (15° C.). Generally for such devices the transition temperature can be between 15° C. to 65° C. (59° F. to 149° F.), and more preferably 10° C. to 40° C. (50° F. to 104° F.). Preferably, the material is maintained in the body above the transition temperature in order to exhibit optimal elasticity qualities.
- Alternatively, and preferably, the sleeve can be fabricated by wire Electrical Discharge Machining (EDM) rather than machined. Additionally, the sleeve can be finished using a shot blast technique in order to increase the surface strength and elasticity of the sleeve.
- Top and side views of the
second wing 1032 are shown inFIGS. 94 and 95 .Second wing 1032 as in several past embodiments includes atab 1034 with abore 1036 which aligns with thebore 1014 of theguide 1010. In this particular embodiment, thesecond wing 1032 includes a cut-out 1038 which is sized to fit over theguide 1010, with thetab 1034 resting in therecess 1012 of theguide 1010. - An alternative configuration of the
second wing 1032 is depicted inFIG. 94 a. In this configuration, thesecond wing 1032 is held at acute angle with respect to thetab 1034. This is different from the situation in the embodiment ofFIGS. 94 and 95 where the second wing is substantially perpendicular to the tab. For the embodiment of the second wing inFIG. 94 a, such embodiment will be utilized as appropriate depending on the shape of the spinous processes. - With respect to the alternative
second wing 1032 depicted inFIGS. 94 b and 95 a,elongated tab 1034 has a plurality of closely positioned bores 1036. The bores, so positioned, appear to form a scallop shape. Each individual scallop portion of thebore 1036 can selectively hold the bolt in order to effectively position thesecond wing 1032 in three different positions relative to thefirst wing 1004. The cut-out 1038 (FIG. 95 a of this alternative embodiment) is enlarged over that ofFIG. 95 as in a position closest to thefirst wing 1004, thesecond wing 1032 is immediately adjacent and must conform to the shape of thesleeve 1016. -
Implant 1050 ofFIG. 97 is similar to theimplant 1000 inFIG. 92 with the major difference being that a second wing is not required. Theimplant 1050 includes a central body as doesimplant 1000. The central body is surrounded by asleeve 1016 which extends between afirst wing 1004 and aguide 1010. Theguide 1010 in this embodiment is substantially cone-shaped without any flats and with no bore as there is no need to receive a second wing. The sleeve and the central body as well as the first wing and guide act in a manner similar to those parts of theimplant 1000 inFIG. 92 . It is to be understood a cross-section of thisimplant 1050 throughsleeve 1016 can preferably be likeFIG. 93 a. This particular embodiment would be utilized in a situation where it was deemed impractical or unnecessary to use a second wing. This embodiment has the significant advantages of the sleeve being comprised of super-elastic alloy materials as well as the guide being utilized to guide the implant between spinous processes while minimizing damage to the ligament and tissue structures found around the spinous processes. -
Implant 1060 is depicted inFIG. 98 . This implant is similar to theimplants 1000 ofFIG. 92 and theimplant 1050 ofFIG. 97 , except that this implant does not have either first or second wings.Implant 1060 includes asleeve 1016 which surrounds a central body just ascentral body 1002 ofimplant 1000 inFIG. 93 . It is to be understood that a cross-section of thisimplant 1060 throughsleeve 1016 can preferably be likeFIG. 93 a.Implant 1060 includes aguide 1010 which in this preferred embodiment is cone-shaped.Guide 1010 is located at one end of the central body. At the other end is astop 1062.Stop 1062 is used to contain the other end of thesleeve 1016 relative to the central body. This embodiment is held together with a bolt such asbolt 1006 ofFIG. 93 that is used for the immediate above two implants. For theimplant 1060 ofFIG. 98 , such a device would be appropriate where the anatomy between the spinous processes was such that it would be undesirable to use either a first or second wing. However, this embodiment affords all the advantageous described hereinabove (FIGS. 92 and 97 ) with respect to the guide and also with respect to the dynamics of the sleeve. -
FIGS. 99 and 100 depict animplant system 1070.Implant system 1070 includes asleeve 1072 which is similar to and has the advantageous ofsleeve 1016 of the embodiment inFIG. 92 .Sleeve 1072 does not, however, have any spokes. Additionally,implant system 1070 includes aninsertion tool 1074.Insertion tool 1074 includes aguide 1076 which in a preferred embodiment is substantially cone-shaped.Guide 1076 guides the insertion of thesleeve 1072 and theinsertion tool 1074 between adjacent spinous processes. Theinsertion tool 1074 further includes acentral body 1078, astop 1080, and ahandle 1082. Theguide 1076 at its base has dimensions which are slightly less than the internal dimensions of thesleeve 1074 so that the sleeve can fit over theguide 1076 and rest against thestop 1080. Thetool 1074 with theguide 1076 is used to separate tissues and ligaments and to urge thesleeve 1072 in the space between the spinous processes. Once positioned, theguide insertion tool 1074 can be removed leaving thesleeve 1072 in place. If desired, after the sleeve is positioned, position maintaining mechanisms such asspringy wires 1084 made out of appropriate material such as the super-elastic alloys and other materials including titanium, can be inserted using a cannula through the center of thesleeve 1072. Once inserted, the ends of the retaining wires 1084 (FIG. 99 ) extend out of both ends of thesleeve 1072, and due to this springy nature, bent at an angle with respect to the longitudinal axis of thesleeve 1072. These wires help maintain the position of the sleeve relative to the spinous processes. - Another embodiment of the invention can be seen in
FIG. 101 which includesimplant 1100.Implant 1100 has many similar features that are exhibited with respect toimplant 1000 inFIG. 92 . Accordingly, elements with similar features and functions would be similarly numbered. Additionally, features that are different fromimplant 1100 can be, if desired, imported into and become a part of theimplant 1000 ofFIG. 92 . - As with
implant 1000,implant 1100 includes a central body 1002 (FIG. 102 ) with afirst wing 1004 and abolt 1006 which holds the first wing and the central body together. In this particular embodiment, the central body is made in two portions. Thefirst portion 1102 is in the shape of a truncated cone with an oval or elliptical base and asecond portion 1104 includes a cylindrical central portion with a distal end in the shape of atruncated cone 1103 with an oval or elliptical base. In addition, in this particular embodiment, formed with the central body is theguide 1010 which has an oval or elliptical base.Bolt 1006 is used to secure the first wing through thesecond portion 1104 with thefirst portion 1102 held in-between. In this particular embodiment, theguide 1010 in addition to includingrecess 1012 and bore 1014 includes agroove 1106 which receives a portion of thesecond wing 1032. - In this particular embodiment, the
sleeve 1016 is preferably oval or elliptical in shape as can be seen inFIG. 102 a. The central body can be oval, elliptical or circular in cross-section, although other shapes are within the spirit and scope of the invention. Thesleeve 1016 held in position due to the fact that the truncatedconical portion 1102 and the corresponding truncatedconical portion 1103 each have a base that is elliptical or oval in shape. Thus, the sleeve is held in position so that preferably the major dimension of the elliptical sleeve is substantially perpendicular to the major dimension of the first wing. It is to be understood that if the first wing is meant to be put beside the vertebrae so that the first wing is set at an angle other than perpendicular with respect to the vertebrae and that the sleeve may be held in a position so that the major dimension of the sleeve is at an angle other than perpendicular to the major dimension of the first wing and be within the spirit and scope of the invention. This could be accomplished by tighteningbolt 1006 with thefirst wing 1004 andsleeve 1016 so positioned. In such a configuration, the major dimension of the sleeve would be preferably positioned so that it is essentially parallel to the length of the adjacent spinous processes. So configured, the elliptical or oval shape sleeve would bear and distribute the load more evenly over more of its surface. - It is to be understood that the sleeve in this embodiment has all the characteristics and advantages described hereinabove with respect to the above-referenced super-elastic sleeves.
- The second wing as discussed above, can come in a variety of shapes in order to provide for variations in the anatomical form of the spinous processes. Such shapes are depicted in
FIGS. 103, 104 , 105, 106, and 107. In each configuration, thesecond wing 1032 has aupper portion 1108 and alower portion 1110. InFIG. 104 , the lower portion is thicker than the upper portion in order to accommodate the spinous process, where the lower spinous process is thinner than the upper spinous process. InFIG. 105 , both the upper and lower portions are enlarged over the upper and lower portions ofFIG. 103 to accommodate both the upper and lower spinous processes being smaller. That is to say that the space between the upper and lower portions of the first and second wings are reduced due to the enlarged upper and lower portions of the second wing. - Alternative embodiments of second wings, as shown in
FIGS. 104 and 105 , are depicted inFIGS. 106 and 107 . In theseFIGS. 106 and 107 , thesecond wing 1032 accommodates the same anatomical shape and size of the spinous processes as does the second wing inFIGS. 104 and 105 respectively. However, in the embodiments of thesecond wing 1032 ofFIGS. 106 and 107 , substantial masses have been removed from the wings. The upper andlower portions central portion 1112 of thesecond wing 1032. - It is to be understood that in this embodiment, if desired, the second wing may not have to be used, depending on the anatomy of the spinal column of the body, and this embodiment still has the significant advantages attributable to the
guide 1010 and the functionality of thesleeve 1016. - The
implant 1120 as shown inFIGS. 108 and 109 , is similar toimplant 1100 which is in turn similar toimplant 1000. Such similar details have already been described above and reference here is made to the unique orientation of the first andsecond wings longitudinal axis second wings FIG. 108 , they would meet to form an A-frame structure as is evident from the end view ofFIG. 109 . In this particular embodiment, as can be seen inFIGS. 109 and 110 , thetab 1034 is provided an acute angle to the remainder of thesecond wing 1124. Further, thegroove 1018 formed in the implant is sloped in order to accept thesecond wing 1124. Accordingly, thispresent implant 1120 is particularly suited for an application where the spinous process is wider adjacent to the vertebral body and then narrows in size at least some distance distally from the vertebral body. It is to be understood that a cross-section of thisimplant 1120 throughsleeve 1016 can preferably be likeFIG. 93 a . - An additional embodiment of the
implant 1150 is shown inFIG. 111 .Implant 1150 has features similar to those described with respect toFIG. 94 b. -
Implant 1150 includes acentral body 1152 with afirst wing 1154, wherecentral body 1152 includes elongatedgroove 1156 which extends to theguide 1158. Ascrew 1160 is received in a threaded bore located in theelongated groove 1156. - The
second wing 1162 includes acentral body 1164 which is substantially perpendicular to thesecond wing 1162. - The
central body 1164 includes a plurality ofbores 1166 provided therein. These bores are formed adjacent to each other in order to define a plurality of scallops, each scallop capable of retainingbolt 1160 therein. As can be seen inFIG. 114 , the second wing includes a cut-out 1168 such that with thecentral body 1164 of the second wing received in thegroove 1156 of the central body associated with the first wing, the remainder of the second wing is received over thecentral body 1152 of theimplant 1150. With thisimplant 1150, the distance between the first and second wings can be adjusted by selectively placing thebolt 1160 through one of the five specified bores defined by the scalloped plurality ofbores 1166. Accordingly,FIG. 112 depicts the implant where the first and second wings are widest apart in order to accommodate spinous processes of greater thickness.FIG. 111 shows the middle position between the first and second wings in order to accommodate average size spinous processes. - It is to be understood that preferably during the surgical process, the
central body 1152 is urged between spinous processes. After this has occurred, the second wing is guided by the other sides of the spinous processes from a path which causes the plane of the second wing to move substantially parallel to the plane of the first wing until thecentral body 1164 associated with thesecond wing 1162 is received in the groove of 1156 of thecentral body 1152 associated with thefirst wing 1154. After this has occurred, thebolt 1160 is positioned through aligned bores associated with thesecond wing 1162 and thecentral body 1152 in order to secure the second wing to the central body. - While
embodiment 1150 does not depict a sleeve such assleeve 1016, such asleeve 1016 could be placed overbody 1152 and be within the spirit of the invention. -
Implant 1200 of the invention is depicted inFIGS. 119 a and 119 b. This implant includes thefirst wing 1202 andsleeve 1204 and aguide 1206. An alternative to this embodiment further includes, as required,second wing 1208 as depicted inFIGS. 120 a and 120 b. - As can be seen in
FIG. 121 a and 121 b, thefirst wing 1202 includes a bore which receives acentral body 1210. Preferably, the central body is pressed fit through the bore of the first wing although it is to be understood that other securing mechanisms such as through the use of threads and still other mechanisms can be used to accomplish this task. Additionally, in this particular embodiment first andsecond pins 1212 extend from thefirst wing 1202, each along an axis which is substantially parallel to thelongitudinal axis 1214 of thecentral body 1210. In this particular embodiment, thedistal end 1216 of thecentral body 1210 is threaded in order to be coupled to theguide 1206. - As can be seen in
FIGS. 122 a, 122 b and 122 c, theguide 1206 in this particular embodiment is pointed in order to allow the implant to be inserted between, and if necessary distract, adjacent spinous processes. Theguide 206 includes a threaded bore 1218 which is designed to accept the threadedend 1216 of thecentral body 1210 in order to secure the guide to the central body and additionally for purposes of retaining the sleeve between theguide 1206 and thefirst wing 1202. - As can be seen in
FIG. 123 a thesleeve 1204 is preferably cylindrical, and oval or elliptical in shape in cross-section. It is to be understood thatsleeve 1204 can have other shapes as described throughout the specification and be within the spirit and scope of the invention. In this particular embodiment,sleeve 1204 has at least one major diameter and one minor diameter in cross-section.Sleeve 1204 includes acentral bore 1220 which extends the length ofsleeve 1204 andcurve grooves 1222 which are formed aboutcentral bore 1220 and extend only part way into the body of the sleeve. In this particular embodiment, thecurved grooves 1222 describe an arc of about 60°. It is to be understood that in other embodiment, this arc can be less than 60° and extend past 120°. - The
sleeve 1204 is received over thecentral body 1210 of theimplant 1200 and can rotate thereon about thelongitudinal axis 1214 of thecentral body 1210. When this particular embodiment is assembled, thegrooves 1222 have received therein thepins 1212 that extend from thefirst wing 1202. Accordingly, the pins inserted in thegrooves 1222 assist in the positioning of the sleeve relative to the remainder of theimplant 1200. With thepins 1212 received in thecurved grooves 1222, the pins limit the extent of the rotation of the sleeve about the central body and relative to the first wing. - As can be seen in
FIGS. 124 a, 124 b, and 124 c, the sleeve is free to rotate relative to the longitudinal axis of thecentral body 1210 and thus relative to thefirst wing 1202 of the embodiment shown inFIGS. 119 a and 119 b. The sleeve can rotate relative to asecond wing 1208, when the second wing is utilized in conjunction with the embodiment ofFIGS. 119 a and 119 b. The pins limit the rotation of the sleeve. In an alternative embodiment, the pins are eliminated so that the sleeve can rotate to any position relative to the first wing. - It is to be understood that the sleeve can be comprised of biologically acceptable material such as titanium. Additionally, it can be comprised of super-elastic material such as an alloy of nickel and titanium, much as described hereinabove with respect to other embodiments.
- The great advantage of the use of the
sleeve 1204 as depicted in the embodiment ofFIGS. 119 a and 119 b is that the sleeve can be rotated and repositioned with respect to thefirst wing 1202, and/or thesecond wing 1208 should the second wing be used in the embodiment, in order to more optimally position theimplant 1200 between spinous processes. It is to be understood that the cortical bone or the outer shell of the spinous processes is stronger at an anterior position adjacent to the vertebral bodies of the vertebra than at a posterior position distally located from the vertebral bodies. Accordingly, there is some advantage of having theimplant 1200 placed as close to the vertebral bodies as is possible. In order to facilitate this and to accommodate the anatomical form of the bone structures, as the implant is inserted between the vertebral bodies and urged toward the vertebral bodies, thesleeve 1204 can be rotated relative to the wings, such aswing 1202, so that the sleeve is optimally positioned between the spinous processes, and thewing 1202 is optimally positioned relative to the spinous processes. Without this capability, depending on the anatomical form of the bones, it is possible for the wings to become some what less than optimally positioned relative to the spinous processes. -
FIGS. 125, 126 and 127 depict three alternative embodiments of the invention as can be seen through a line parallel to line 124-124 ofFIG. 119 b. - In
FIG. 125 , thesleeve 1204 is rotatable aboutcentral body 1210. In this embodiment, however, thesleeve 1204 design does not include thegrooves 1222 as previously depicted in the embodiment shown inFIG. 123 a. Thus, without pins, the sleeve is completely free to rotate about thecentral body 1210. - An alternative embodiment is shown in
FIG. 126 . In this embodiment, thesleeve 1204 is essentially a thin wall cylinder which is spaced from thecentral body 1210.Sleeve 1204 is free to move relative tocentral body 1210.Sleeve 1204 can rotate relative tocentral body 1210. In addition,sleeve 1204 can take a somewhat cocked or skewed position relative tocentral body 1210. - A further embodiment, it is shown in
FIG. 127 . This embodiment is somewhat similar to the embodiment shown inFIG. 126 except that in this case, several pins project from the first wing in order to some what limit and restrict the motion of thesleeve 1204. As shown inFIG. 127 , four pins are depicted. It is to be understood however that such an embodiment can include one, two, three, four or more pins and be within the spirit and scope of the invention. It is to be understood that if the embodiment is used with a second wing, that similar pins can extend from the second wing. However, in the embodiment using a second wing, the pins would preferably be somewhat flexible so that they could snap into the inside of thesleeve 1204 as the second wing is inserted relative to the central body and secured in place. In the embodiment shown inFIG. 127 , thesleeve 1204 is free to rotate about the longitudinal axis of thecentral body 1210 and is somewhat restricted in this motion and its ability to become skewed relative to the longitudinal axis of the central body by the pins. - The embodiments of
FIG. 128 is an advantageous alternative to that ofFIG. 93 a. In this embodiment, thecentral body 1002 is similar to that as shown inFIG. 93 a. Thesleeve 116 is comprised of twosleeve portions sleeve 1016, if formed of super-elastic material, is that the sleeve can be formed in a manner which optimizes the super-elastic characteristics of such material in order to enhance its ability to repeatedly deflect under load. In this particular embodiment, thesleeve portions central body 1002. - An alternative embodiment of the invention is shown in
FIG. 128 . This embodiment is most favorably used with the embodiment ofFIG. 119 a and 119 b. In this particular embodiment, thesleeve 1204 is designed to rotate about thecentral body 1210.Sleeve 1204 includes acentral member 1230 which includes a bore that receives thecentral body 1210. Thecentral member 1230 is rotatable about thecentral body 1210 of theimplant 1200. Thecentral member 1230 includes first andsecond grooves sleeve members FIG. 128 . These sleeve members can be snapped into position relative to thecentral member 1230 of thesleeve 1204. It is to be understood that other mechanisms can be used to secure the C-shaped sleeve member relative to the central member of the sleeve and be within the spirit and scope of the invention. Further, it is to be understood that thesleeve members grooves -
Embodiment 2000 of the supplemental spine fixation device of the invention is depicted inFIG. 130 . Thisembodiment 2000 includes ahub 2002 to which is adjustably secured afirst hook member 2004 and asecond hook member 2006.First hook member 2004 includes ahook 2008 which is more fully described hereinbelow, and ashaft 2010 extending therefrom. Similarly,second hook member 2006 includes ahook 2012 and ashaft 2014 extending therefrom. As described more fully hereinbelow,hook 2008 is swivelly or pivotably mounted toshaft 2010. It is to be understood that the description and functionality offirst hook member 2004 applies equally well to that ofsecond hook member 2006. Theshaft 2010 in this embodiment includes arack 2016 which can mate selectively withrack 2018 ofhook member 2006. These tworacks second hook members hub 2002. Theshafts bore 2020 in thehub 2002, selectively interlocked together and are then lockingly positioned using a locking mechanism such as thescrew 2022. As is described more fully below, thehooks hooks shafts - Movably mounted to the
hub 2002 is a shaft 2024 (FIG. 131 ) and extending from theshaft 2024 is aninter-spinous process guide 2026. Theshaft 2024 at a proximal end includes a crossbar ortab 2028 which is slidingly or movingly received in aslot 2030 of thehub 2002. Once thetab 2028 is received in theslot 2030, the slot can be pinched off or slightly deformed at its open end using a punch or other mechanism in order to prevent thetab 2028, and thus theshaft 2024 and theguide 2026 from being removed from thehub 2002. With thetab 2028 located in theslot 2030, the shaft and also theguide 2026 extending from the distal end of theshaft 2024 are free to move relative to the hub and also relative to thefirst hook member 2004 and thesecond hook member 2006. This movement, as well as the ability of thehooks shafts embodiment 2000 to conform to the spinous process anatomy. - Movably mounted on the
shaft 2024 is a spacer orsleeve 2032.Spacer 2032 includes acentral bore 2034 through which theshaft 2024 extends. Thespacer 2032 is thus able to rotate about theshaft 2034. Thespacer 2032 is cylindrical and in this particular embodiment is oval or elliptical in shape. In addition, the base of theguide 2026 is also somewhat elliptical in shape in order to make a smooth transition between theguide 2026 and thespacer 2032 as the guide and spacer are inserted between the spinous processes in order to distract apart the spinous processes during the insertion process. As thespacer 2032 is rotatable on theshaft 2024, and as thespacer 2032 is elliptically shaped, it can be inserted in one position and then as theentire embodiment 2000 is positioned to the final securing position, thespacer 2032 can rotate about theshaft 2024 to accommodate the shape of the space between the spinous processes as the spacer is moved from a posterior position to an anterior position. - The
spacer 2032 can include a second alternative spacer embodiment 2036 (FIG. 131 a) in substitution for thespacer 2032.Spacer 2036 includes anelongated slot 2038 into which theshaft 2024 can be received.Elongated slot 2038 not only allows thespacer 2036 to rotate about theshaft 2024, it also allows it to translate relative toshaft 2024. Such translation in this embodiment is substantially perpendicular to the shaft, in any direction to which thespacer 2036 is rotated. Thus, in this embodiment the degrees of freedom which accommodate the anatomical shape of the spinous processes and the space therebetween, including the ligaments and tissues associated therewith, include (1) the ability of thehooks hooks hub 2002 and be locked to the hub, (3) the ability of theshaft 2024 to move in theslot 2030 of the hub, and (4) finally the ability of thespacer 2036 to both rotate and translate on theshaft 2024. - Before proceeding to more specific details of this
embodiment 2000, it is to be understood that the same features of the spacer, the shaft, and the lead-in guide, which are found in other embodiments such as by way of example only, the embodiments ofFIGS. 10, 16 , 20, 22, 86, 88, 92, and 119 b, and other figures, can be incorporated into this embodiment. By way of example only, theimplant 2000 can be comprised of stainless steel, titanium or other biologically acceptable materials. The shape of the lead-in plug can be cone shaped, pyramid shaped, and other shapes with a small lead-in cross-section expanding into a larger cross-section which is similar to the cross-section of thespacer 2032, in order to gradually distract apart the spinous processes to a sufficient distance so that thespacer 2032 or thespacer 2036 can conveniently fit between the spinous processes. Further, the spacer, as shown in the other embodiments, can include a spacer made of stainless steel or titanium, or of a super-elastic material or of a silicone. The spacer besides being cylindrical can, from parallelplanar end 2040 to parallelplanar end 2042, be saddle-shaped alongsurface 2041 so that the ends are high and the center portions are low in order to more fully accommodate the shape of the spinous processes and also to spread the load across a broader contact surface between the spinous processes and the spacer. For example, thespacer 2032 could have a shape such as the saddle shape defined by the mated together components of the embodiment ofFIG. 16 . Further, the dimensions of this embodiment as applied to theguide 2006 and thespacer 2032 can be acquired from other embodiments presented herein. - The shape of the
guide 2026 and thespacer 2032 is such that for purposes of insertion between spinous processes, the spinous processes to do not need to be altered or cut away in any manner in order to accommodate this implant. Further, the associated ligaments do not need to be cut away and there would be very little or no damage to the other adjacent and surrounding tissues. Similarly, thehook members - Returning to
FIGS. 135 a-135 f andFIG. 136 , the design of thehook members first hook member 2004. This description applies equally tosecond hook member 2006. As can be seen inFIG. 135 b, thefirst hook member 2004 includes ashaft 2010 which is received in abore 2044 of thehook 2008. This bore receives arounded ball end 2046 seated against a somewhatcircular seat 2048. A screw 2050 (FIG. 135 f) is received in thebore 2044 in order to retain therounded ball end 2046. The other end of thebore 2044,end 2052, as can be seen inFIG. 135 f is oval or elliptical in shape. This allows thehook 2008 to swivel side to side on theshaft 2010 in order to accommodate the spinous process while somewhat restricting the back and forth rocking of thehook 2008 relative to theshaft 2010. This freedom of motion can be seen inFIG. 136 with respect to the upper spinous processes 2054. The hook can swivel side to side in order to accommodate the shape of the upper spinous processes 2054. Thelower hook 2006 additionally can move in order to accommodate the lower spinous processes 2056. As can be seen inFIGS. 135 c and 135 d, thehook 2008 can swivel about 15°. on either side of a central longitudinal axis of theshaft 2010. - Additionally with respect to the
hook 2008, as can be seen inFIGS. 135 a, 135 b, and 135 e, the hook includes a convexinner surface 2058 in order to accommodate the varying surface shape of the spinous processes, and in order to even out the load transferred between the hook and the spinous processes. - The
embodiment 2000 can be implanted in a number of methods, preferably, once a spine fixation device is implanted between the vertebral bodies. In this particular embodiment, through a small incision the hub, spacer, and guide are inserted with the guide and spacer inserted between the spinous processes. Once this is accomplished, a first hook member and then a second hook member is secured about the respective spinous processes. The shafts of the hook members are then inserted through the bore of thehub 2002 until the spinous processes are brought tight against the spacer. The hooks are appropriately positioned on the spinous processes as depicted inFIG. 136 . After this has been accomplished, thesecuring mechanism 2022 is tightened in order to lock the hooks in place and to secure the spinous processes in a rigid manner relative to each other and relative to thedistracting spacer 2032. Alternatively, the spinous ligaments can hold the spinous processes tightly against the spacer and the hooks can be moved and locked into tight contact with the spinous processes. - The above procedure can have variations. By way of example only, the hooks can be inserted first through the incision and then the guide, spacer and hub can be inserted. Once this is accomplished the hooks can be mated to the hub.
- In another embodiment and method not depicted, the physician can insert the
shaft 2024 on which thespacer 2032 is mounted into theslot 2030 of thehub 2002 and can close off the slot with a securing screw in order to retainshaft 2024. This process is in contrast to the shaft being secured in the slot during the manufacturing process. The securing screw would be similar to securingscrew 2022 and would be placed in a bore made at the top ofslot 2030. The physician could accordingly insert thetab 2028 of theshaft 2024 in theslot 2030, and then secure the tab in place with the securing screw. - Still an alternative method would be for the
device 2000 to be inserted through a larger incision, withdevice 2000 fully assembled. Once inserted thescrew 2022 could be loosened so that the hook members could be positioned around spinous processes at about the same time that the guide and spacer are inserted between the spinous processes. Once this is accomplished, the spinous processes could be drawn down tightly around the spacer, with the hooks tightly around the spinous processes and secured firmly into thehub 2002 with the securingscrew 2022. - In all of the above procedures, it is advantageous that the
device 2000 can address the adjacent spinous processes from one side of the spinous processes and not require exposure of both sides of the spinous processes and thus the procedure is less traumatic to the surgical site. - Still an alternate insertion method would be to insert the device fully assembled with the hook rotated at 90° to the final position shown in
FIG. 130 . Once the hooks are positioned adjacent to the spinous processes, the hooks could be rotated to the position shown inFIG. 130 . Then simultaneously the guide and spacer could be inserted between the spinous processes, as the hooks are positioned about the spinous processes. The hooks are then drawn together, causing the spinous processes to be held firmly against the spacer. Once this is accomplished thescrew 2022 can be securely fastened to thehub 2002. - With respect to the embodiment of
FIG. 130 , this embodiment as fully described above can be used as a supplemental fixation or augmentation device for the lumbar level fusion of the L4/L5 vertebrae and above vertebrae, and also for the L5/S1 and below vertebrae. Thus, thisdevice 2000 can be used with respect to fusion of any of the vertebrae up and down the spinous processes. - Another
embodiment 2100 of the invention can be seen inFIGS. 137-140 . Components and features of thisembodiment 2100 which are similar to components and features of theembodiment 2000 have similarly least significant digits. Thus the hub forembodiment 2100 would be 2102. The main difference between theembodiment 2100 and the previously describedembodiment 2000 is directed to thehub 2102 and theshafts shafts FIG. 130 . As can be seen inFIG. 138 ,shaft 2110 is substantially rectangular in cross-section and include rack orteeth 2116.Shaft 2114 is shaped as a fork with twotines teeth 2118. Theshaft 2110 of thefirst hook member 2104 slides between the twotines FIG. 139 , with theshaft 2110 slipped between the twotines shafts rectangular bore 2120 of thehub 2102, the top cap 2103 (which is shown both from the top side (FIG. 138 ) and from the bottom side (FIG. 138 b)) can be placed over thehub 2102. The teeth orrack 2105 on the bottom side of thecap 2103, mesh with the teeth orrack screw 2122 can be inserted through the indicated bore so that thecap 2103 can tighten down on thehub 2102, locking theshafts - All the other features, dimensions, characteristics, materials, methods of insertion, and methods of operation of the embodiment shown in
FIG. 138 are similar to or derivations from that shown in the embodiment ofFIG. 130 . - Another embodiment of the invention is depicted in
FIGS. 141-143 . This embodiment is similar to theother embodiments embodiment 2200 is identified ashub 2202. - In this particular embodiment, the hub has rigidly affixed thereto
shaft 2224. Hereshaft 2224 does not slide in a slot as happens with respect to the prior twoembodiments Shaft 2224 can be screwed intohub 2202 or integrally formed withhub 2202. Additionally, theguide 2226 can be integrally formed with theshaft 2224 or in other manners fastened to theshaft 2224 as with a thread mechanism. In this particular embodiment, as can be seen inFIG. 143 , theshaft 2224 is integrally formed with thehub 2202 and theshaft 2224 includes a threadedextension 2225 onto which is screwed theguide 2226. For this particular embodiment, the sleeve orspacer 2236 includes theelongated slot 2238 in order to provide for freedom of movement between the sleeve orspacer 2236, thehub 2202, and the first andsecond hook members - In this particular embodiment the
shaft embodiment 2000. In other words each has a rack or teeth which mate with the other.Shafts semi-circular bore 2220 of thehub 2202, and then thecap 2203 is mated on top of thehub 2202. The cap includes asemi-circular bore 2207 which is positioned over theupper shaft 2210. Both bores 2207 and 2220 include ribs, teeth, or threads that run along the length of the bores. These ribs, teeth, or threads are urged against the shafts in order to assist in locking the shafts in place. Alternatively, the ribs, teeth, or threads of the bores can be across the length of the bores. Theshafts cap 2203 is positioned over thehub 2202, thescrew 2222 is positioned in the bore of thehub 2202 in order to lockingly position the first andsecond hook members embodiment 2200, the degrees of freedom are attributable to (1) theslot 2238 in thespacer 2236, (2) theshafts hooks hooks - As indicated above, all the other features, materials, aspects, dimensions, and so forth, of the
embodiment 2200 are similar to and can be specified according to theother embodiments - A preferred method of insertion of this
embodiment 2200 into a patient is as follows. Initially through a small incision the guide, spacer and hub are inserted so that the guide is positioned between and distracts apart adjacent spinous processes, allowing the spacer to come between the spinous processes. The spacer and guide can be moved in a posterior to anterior direction, and the spacer is able to rotate and translate in order to accommodate such movement. After this is accomplished, the first and second hook members are positioned through the incision and around upper and lower spinous processes. Once that is accomplished, the spinous processes are urged towards each other and about the spacer, if this is not already the condition caused by the insertion of the spacer in order to distract the spinous processes. Then the racks of the shafts are meshed together, and the cap is placed upon the hub in order to secure the hooks firmly to the hub and thus to secure the spinous processes rigidly in position about the spinous processes. - A
further embodiment 2300 of the invention is depicted inFIG. 144 . InFIG. 144 , thehub 2302 of this embodiment is depicted. This hub could be used, for example, with the embodiment shown inFIG. 141 and similar components are similarly numbered. In this embodiment, thehub 2302 includes anintegral shaft 2324 with a threadedend 2325 which can accept a guide such asguide 2226 ofFIG. 141 . Unlike the embodiment inFIG. 141 , thishub 2203 does not have a cap. Insteadhub 2302 includes anopen bore 2320 which is shaped in order to receiveshafts Bore 2320 has aportion 2321 which is circular and which receives the matedshaft - Once this is accomplished, a
screw 2322 is received in the threadedbore 2323 in order to lockingly position the matedshafts open bore 2320 and no cap, mating of theshafts open bore 2320 of thehub 2302 can be done quickly and efficiently. -
FIG. 145 shows ahub 2402 of anembodiment 2400. Thishub 2402 is similar tohub 2302, with theopen bore 2420 having a shape which is different from the shape ofbore 2320. In this embodiment bore 2420 includes a flat 2421 and acircular portion 2423. Theshafts open bore 2420. In particular,shaft 2414 has a flat which mates to flat 2421 and the combinedshafts 2410 and 2424 have a circular portion which would mate to thecircular portion 2423 of thebore 2420. Otherwise,hub 2202 would function similarly tohub 2302. -
FIGS. 146 a, 146 b, and 146 c depict ahub arrangement 2502 of anembodiment 2500 of the invention. In this embodiment,hub 2502 has twocomponents Component 2511 includes anopen bore 2520 which is specially shaped in order to registershafts 2510, 2514 of the first and second hook members. In this particular embodiment,shaft 2510 is semi-circular in cross-section while shaft 2514 is triangular-shaped in cross-section. The triangular shape of shaft 2514 mates with thecorner 2525 of theopen bore 2520. The term open bore refers to 2520 and also tobores FIGS. 144 and 145 , and means that not only are both ends of the bore open, but there is a longitudinal slot along the length of the bore which is open, allowing access to the bore from the side of the bore. Once theshafts 2510, 2514 are inserted as shownFIG. 146 c, ascrew 2522 can be tightened through a bore of thehub 2502, locking the shafts in place. Once this has occurred, thefirst portion 2511 of thehub 2502 can be mated into thesecond portion 2513 of thehub 2502. In this embodiment, the second portion of thehub 2513 includes aslot 2515 into which can be slid or snapped into thefirst portion 2511. Thefirst portion 2511 includestangs lips first portion 2511 of thehub 2502 is slid or alternatively snapped into engagement with thesecond portion 2513. Once this occurs, alocking cam 2527 is turned in order to cause a cam member to be urged against thisportion 2511 of the hub in order to lock 2511 to thesecond portion 2513. Alternatively, it is to be understood that the act of sliding or snappinghub portion 2511 intohub portion 2513 can be sufficient to lockportion 2511 intoportion 2513. This embodiment further includesspacer 2536 and cone shapedguide 2526. - Other features, functions, dimensions, and so forth of this embodiment are similar to the other embodiments as, for example, the embodiment of
FIG. 141 . - For purposes of insertion, one insertion methodology can be to insert the
second hub portion 2513 with theguide 2526 into the position between the spinous processes. After this is accomplished, the hook members can be positioned about the spinous processes and locked into thefirst hub portion 2511. Then thefirst hub portion 2511 could be slid or snapped into engagement with thesecond hub portion 2513. Following that, thecam 2527 can be turned in order to secure thefirst hub portion 2511 to thesecond hub portion 2513. -
FIGS. 147 a and 147 b depict anotherembodiment 2600 of the invention. Thisembodiment 2600 includes ahub 2602 and a rack and pinion arrangement. The rack and pinion arrangement includes first andsecond pinions shafts shafts FIG. 131 . For simplicity, these hooks have been left off ofFIGS. 147 a, 147 b. The position of theshafts shafts screw 2664 against thepinion 2660. A similar screw, not shown, would tighten downpinion 2662. - Another embodiment of the invention,
embodiment 2700 is depicted inFIGS. 148 a and 148 b. In this embodiment abevel gear arrangement 2770 is contained in thehub 2702.Bevel gear arrangement 2770 includes afirst bevel gear 2772 and asecond bevel gear 2774.Bevel gear 2772 has ashaft 2776 extending therefrom with aslot 2778.Slot 2778 can receive a tool for turning thebevel gear 2772.Bevel gear 2774 is mated to a threadedshaft 2710 of thehook member 2704. In this particular embodiment, the hook is not shown as is the case for the embodiment ofFIGS. 147 a and 147 b. When thebevel gear 2772 is turned, it turnsbevel gear 2774. The turning ofbevel gear 2774 causes the threadedshaft 2714 to retreat into or extend out of the center of theother shaft 2710. With the hook members positioned around spinous processes, thebevel gear 2772 can be used to turnbevel gear 2774 in order to draw thehook member 2706 toward thehub 2702, tightening the hook members about the spinous processes. - In this
embodiment 2700, ashaft 2724 extends therefrom in order to receive a spacer and a guide in the same manner that, for example, the embodiment ofFIG. 144 receives a spacer and a guide. -
FIGS. 149 a and 149 b depictembodiment 2800 of the invention.Embodiment 2800 includes ahub 2802 which houses aturnbuckle arrangement 2880 which is actuated by aworm gear drive 2882.Turnbuckle 2880 receives the threadedshaft hook members turnbuckle 2880, the threadedshafts worm gear 2882 with a tool placed in theslot 2884, the turnbuckle turns, causing the hook members to extend out of or be urged into thehub 2802. - Extending from the hub is a
shaft 2824 with a threadedend 2825. As with the other embodiments, such as the embodiment inFIG. 144 , a spacer can be placed on theshaft 2824 and a guide can be placed on the threadedend 2825. - The preferred method of inserting this embodiment is to insert the embodiment as a whole, placing the guide and spacer between the spinous processes. The hooks would be initially rotated 90° from their final orientation. Once inserted adjacent to the spinous processes, the hooks would be rotated by 90°. and the spacer and the hooks would be further urged into contact with the spinous processes. Once this has occurred, the turnbuckle would be turned in order to tighten the hooks about the spinous processes.
- Another
embodiment 2900 of the invention is depicted inFIG. 150 . This embodiment is similar to several of the other embodiments and, in particular, to the embodiment shown inFIG. 130 . Accordingly, similar elements will have similar least significant numbers. By way of example, the hub is designated 2902. In this particular embodiment, the hub is comprised of two components, thefirst hub component 2911 and thesecond hub component 2913. This is somewhat similar to the hub components shown inFIG. 146 b. - The two hook members are secured to the
first hub component 2911 in much the same manner as the hook members ofFIG. 130 are secured to the hub inFIG. 130 . - The
hub 2902 is divided intofirst hub component 2911 andsecond hub component 2913 in order to add flexibility in the positioning of the guide and spacer fitted tosecond hub component 2913 with respect to the first andsecond hook members first hub component 2911. Thus, should the anatomy of the spine and in particular the spinous process require, thespacer 2936 and theguide 2926 can be moved relative to the first andsecond hook members second hub component 2913 relative to thefirst hub component 2911. This can be accomplished by aligning thebore 2980 over one of the plurality ofbores 2982 positioned through thefirst hub component 2911. After this is accomplished, a threaded screw 2984 can be inserted throughsmooth bore 2980 and engage one of the threadedbores 2982 in order to secure thesecond hub component 2913 to thefirst hub component 2911, thus positioning the sleeve orspacer 2936 in a desired location relative to the first and second hook members. - Yet another embodiment of the
invention 3000 is depicted inFIG. 151 .Embodiment 3000 is meant for a double level spinous process fixation. That is to say that three spinous processes are engaged and rigidly fixed together. Such a situation would occur, for example, when there is a double level primary fusion. That is, three adjacent vertebral bodies are all fused together. In such a situation a double level supplementalspine fixation device 3000 would be used. Thisembodiment 3000 could be designed using any of the other embodiments depicted heretofore.Embodiment 3000 is in this particular instance modeled after theembodiment 2000 shown inFIG. 141 . Accordingly, the elements that are similar toFIG. 141 have similarly least significant digits. By way of example, the hubs ofFIG. 151 are both designated 3002 in accordance with the designation ofFIG. 141 . Similarly, the hub caps, sleeves, hook members, spacers, and guides are similarly numbered. In this embodiment two hubs, two spacers, and two guides are required as thefirst guide 3026 and thespacer 3036 would be inserted between first and second spinous processes, while thesecond guide 3026 andspacer 3036 would be inserted between the second and third spinous processes. Thehook members - A preferred method of insertion of the device relative to three spinous processes would be to insert the guides and spacer between the first and second, and then the second and third spinous processes in order to distract apart the first and second spinous processes and also to distract apart the second and third spinous processes. After this is accomplished, the first hook member would be placed about the first spinous process and the second hook member would be placed about the third spinous process. The shafts of the hook members would be inserted in the
respective hubs 3002. In this situation, the shafts are both up-facing racks or teeth as shown inFIG. 151 . A linkingshaft 3039 has downwardly facing racks or teeth. Thus the upwardly facing rack or teeth of thefirst hook member 3204 would be laid in theupper hub 3002 with the teeth facing up. The teeth of themember 3039 facing down would engage the rack or teeth of thefirst hook 3204. Once this is accomplished, the cap will be placed over the hub and the screw inserted in order to rigidly secure the hook member and theshaft 3039 relative to theupper hub 3002. Then the shaft of thesecond hook 3206 would be positioned in thelower hub 3002. The rack ofshaft 3039 would mesh and lock with the rack of the shaft of thesecond hook member 3206. Once this is accomplished, thecap 3203 would be placed over the hub and the screw would be inserted through the cap into the hub in order to secure theshaft 3039 and thesecond hook member 3206 relative to the lower hub. - An
alternate embodiment 3100 of the supplemental spine fixation device of the invention is depicted inFIG. 152 . Thisembodiment 3100 includes ahub 3102 to which is adjustably secured afirst hook member 3104 andsecond hook member 3106.First hook member 3104 includes ahook 3108 which is more fully described herein below, and ashaft 3110 extending therefrom. Similarly,second hook member 3106 includes asecond hook 3112 andshaft 3114 extending therefrom.Shaft - As described more fully below,
hook 3108 is swivelly or pivotally mounted toshaft 3110. It is to be understood that the description and functionality of thefirst hook member 3108 applies equally well to that of thesecond hook member 3106. Theshaft 3110, onto whichhook 3108 is mounted in this embodiment, is received inside of theshaft 3114.Shaft 3110 can extend fromshaft 3114 in a telescoping or sliding manner relative toshaft 3114 or alternativelyshaft 3110 can be threaded intoshaft 3114 and the rotation ofshaft 3110 would allow it to extend from or be retracted intoshaft 3114.Shafts bore 3120 of thehub 3102. In thisparticular embodiment shaft 3114 can be press fit or otherwise secured inbore 3120.Shaft 3110 is thus free to move relative to thehub 3102 and theshaft 3114, until thehub 3102 is assembled, lockingshaft 3110 into position in this particular embodiment. This locking arrangement will be discussed more fully below. - The
hooks hooks shafts - Swivelly mounted to the
hub 3102 is ashaft 3124, and extending from theshaft 3124 is an inner-spinous process guide, or lead-in nose, ortissue expander 3126. Theshaft 3124 at its proximal end includes aball 3125, which is received in socket 3127 which is formed by the two portions of thehub 3102. At this ball and socket mechanism, theshaft 3124 is pivotable with respect to thehub 3102. With this arrangement, the tissue expand 3126 has some freedom of movement with respect to thehub 3102. The other end of the shaft 3124 (FIG. 154 a) also includes aball 3129 which fits into asocket arrangement 3131 created in the guide ortissue expander 3126. This arrangement allows the guide ortissue expander 3126 to pivot with respect to theshaft 3124. Accordingly theshaft 3124 is free to pivot relative to the hub and the guide ortissue expander 3126 is free to pivot relative toshaft 3124. This movement, as well as the ability ofhooks shaft embodiment 3100 to conform to the spinous process anatomy. - In this particular embodiment, a sleeve or
spacer 3132 is pivotally mounted on theshaft 3124 along with theguide 3126. In other embodiments as described below, thesleeve spacer 3132 is free to rotate relative to theguide 3126.Spacer 3132 includes acentral bore 3134 in which theshaft 3124 extends. Thespacer 3132 as well asguide 3136 are thus able to pivot and rotate about theshaft 3124. Thespacer 3132 in this embodiment is cylindrical and in this particular embodiment is oval or elliptical in shape. For such shapes, the spacer can have minor diameters of 6 mm, 8 mm, 10 mm, and 12 mm. Smaller and larger diameters are within the spirit and scope of the invention. In addition, the spacer can be egg shaped as more fully described below. Further, the base of theguide 3126 is somewhat elliptical in shape in order to make a smooth transition between theguide 3126 and thespacer 3132 as the guide and spacer are inserted between the spinous processes in order to distract apart the spinous processes. As theguide 3126 and thespacer 3132 are rotatable and pivotable on theshaft 3124, and as thespacer 3132 is elliptically shaped, it can be inserted into one position and then as theentire embodiment 3100 is positioned to the final securing position, thespacer 3132 can be rotated about theshaft 3124 and pivoted relative thereto in order to accommodate the shape of the space between the spinous processes as the spacer is moved generally from a posturing position to an anterior position closer to the spine. - As can be seen in
FIG. 152 and also inFIG. 154 a and 154 c, thecentral bore 3134 of thespacer 3132 has afirst end 3133 which is enlarged and in this particular embodiment substantially elliptical in shape. Thesecond end 3135 is smaller. The reason for this arrangement is most evident inFIG. 154 a and 154 b where in phantom various positions of theshaft 3124 are depicted demonstrating the pivotability of theguide 3124 and thesleeve 3132 relative to thehub 3102. As can be seen inFIG. 154 a and 154 c, in this particular embodiment, theshaft 3124 is inserted into thesmall end 3135 of thesleeve 3132. Aretainer 3137 is inserted relative to theball 3129 of theshaft 3124. The lead-in nose ortissue expander 3126 is then inserted over the small end 3139 of thesleeve 3132 andpin 3141 is inserted into aligned slots in theguide 3126 and thesleeve 3132 in order to assemble together guide 3126, theretainer 3137 and thesleeve 3132 about theball 3129 of theshaft 3124 to create a ball and socket arrangement, whereby theguide 3126 andsleeve 3132 are pivotable and rotatable about theball 3129. - The
spacer 3132 can include analternate embodiment spacer 3136 as shown inFIG. 160 . Thisspacer 3136 can be substituted forspacer 3132.Spacer 3136 includes an egg-shape cross-section with acentral bore 3138 upon which theshaft 3124 can be inserted so as to allow thespacer 3136 to rotate about theshaft 3124. As can be seen inFIG. 160 , the egg-shapedspacer 3136 has ablunt end 3143 and apointed end 3145. The center of thebore 3138 is off-center and more towards thefront end 3134 in this preferred embodiment allowing the pointednose end 3145 to be positionable more closely to the spine. This allows theflat sides blunt end 3143 and pointedend 3145 to be positioned closer to the spine and adjacent to portions of spinous processes which are generally comprised of stronger bone. In addition, theseflat sides bore 3138 can be shaped like bore 3134 (FIG. 154 c) to allow for pivoting and rotating motion. Also, in order to accommodatebore 3138 of the egg-shapedspacer 3136 being off-center, the lead-in guide 3126 would also be egg-shaped and have an off-center position whereshaft 3124 is attached. - In another arrangement, the embodiment as shown in
FIG. 154 c could be modified to so that the small end 3139 of thespacer 3132 or of thespacer 3136 is severed from the remainder of thespacer guide 3126 in order to capture the ball of the shaft. Thus the remainder of thespacer guide 3126. - Before proceeding to more specific details of this
embodiment 3100, it is to be understood that the same features of the spacer, the shaft, and the lead-in guide, which are found on other embodiments such as by way of example only the embodiments ofFIGS. 10, 16 , 20, 22, 86, 88, 92 and 119 b, and other figures can be incorporated into this embodiment. By way of example only, theimplant 3100 can be comprised of stainless steel, titanium, or other biologically acceptable materials. The shape of the lead in plug can be cone shaped, pyramid shaped and other shapes with a small lead in cross-section expanding into a larger cross-section which is similar to the cross-section of thespacer 3132, in order to gradually distract apart the spinous processes to a sufficient distance so that thespacer 3132 or thespacer 3136 can conveniently fit between the spinous processes. Further, the spacer, as shown in the other embodiments, can include a spacer made of stainless steel or titanium or of a super-elastic material or of a silicone. The spacer besides being cylindrical, can be saddle-shaped along the surface which engages the spinous processes so that the high edges and the lower central portions can more fully accommodate the shape of the spinous process. This shape also aides in spreading the load across the broader contact area between the spinous processes and the spacer. For example, thespacer FIGS. 16 . Further, dimensions of this embodiment as applied to theguide 3106 and thespacer 3132 can be acquired from other embodiments presented herein. By way of example only, the guides and spacers can have multiple shapes with the small diameter of the elliptical shape being on the order of 6 mm, 8 mm, 10 mm, 12 mm and 14 mm. - The shape of the
guide 3126 and thespacer 3132 or thespacer 3136 is such that for purposes of insertion between the spinous processes, the spinous processes do not need to be altered or cut away in any manner in order to accommodate this implant. Further, the associated ligaments do not need to be cut away and there would be very little or no damage to the other adjacent and surrounding tissues. Similarly, thehook members - Referring to
FIG. 155 a through 155 e, the design and shape of thehook 3108 is more fully described and depicted. As indicated above, the description will be made with respect to thefirst hook 3108. This description applies equally well tosecond hook 3112. As can be seen inFIG. 155 a, thefirst hook 3108 includes abore 3144 into which theshaft 3110 is received. The shaft has a rounded end which has a bore provided therethrough. This bore mates with thebore 3145 associated with thebore 3144 of thehook 3108. When the bore of theshaft 3110 and thebore 3145 of the hook are aligned, a pin or screw can be inserted in order to lock thehook 3108 onto theshaft 3110. As can be seen inFIG. 155 d, thelower end 3147 of thebore 3144 is oval or ob-round in shape allowing for the shaft to be pivotally received in the bore. Thus thehook 3108 is pivotable with respect to the end of theshaft 3110. The hook thus can pivot in order to accommodate the shape of the spinous process. Turning toFIG. 155 a, the lead in nose or guide ortissue expander 3150 of thehook 3108 is pointed as can be additionally seen inFIG. 155 d and 155 e. This allows theguide 3150 to be easily inserted between spinous processes and spread the tissue so that theconcave recess 3152 can be received over the spinous process. The hook is then locked on the spinous process in order to retain thehook 3108 in place adjacent to the spinous process. Therecess 3152 has a cross-section which is convex in shape in order to accommodate the various surface shapes of the spinous process and in order to even out the load transfer between the hook and the spinous process. - Again with respect to the lead in
nose 3150 in a preferred embodiment, this nose is essentially shaped in the form of a pyramid with all of its sides rounded and curved. This allows thenose 3150 to easily be inserted over and past the spinous process, until theconcave recess 3152 rests over the spinous process with thehook element 3154 caught by the spinous process in order to retain thehook 3108 in place. - As can be seen in
FIG. 153 , thehub 3102 is comprised of two portions. Thelower hub portion 3103 receives theshaft lower portion 3103 also receives theshaft 3124 upon which the nose and sleeve are mounted. Theupper portion 3105 of thehub 3102 mates with alower portion 3103 in order to lock theshaft 3110 and theshaft 3124 in place. Theupper hub portion 3105 is secured to thelower portion 3103 with a screw through threadedbore 3107. As can be seen inFIG. 157 ,upper hub portion 3105 includes a locking projection 3109. This locking projection includes a concave surface. The locking projection 3109, with theupper hub portion 3105 is mated to lowerhub portion 3107, bears down upon theshaft 3110 to lock it in position.Upper hub portion 3105 also includes a half spherical capturedenclosure 3111. With the hub portions assembled, theenclosure 3111 captures the ball end ofshaft 3124. It is to be understood that with respect to the embodiment ofFIG. 153 , that with the two halves of thehub 3102 mated together, a spherically shaped capture enclosure captures the ball end ofshaft 3124. -
FIGS. 158 a and 158 b depict alternative embodiments of a hub arrangement. Thisalternative hub 3160 includeslower hub portion 3162 andupper hub portion 3164. In this embodiment, the ball end of theshaft 3124 is captured in the lower half of thehub 3160. Theupper half 3164 of the hub is mated to the lower half with ascrew 3166 which is placed through aleaf spring 3168 carried with thescrew 3166. The leaf spring bias theupper hub portion 3164 towards thelower hub portion 3162 in order to trap and capture theshaft 3114. Once this is accomplished, thescrew 3166 is tightened in order to complete the assembly. -
FIG. 159 depicts yet an alternate embodiment of the hook and shaft arrangement which could be used instead of, byway of example only,hook 3108 andshaft 3110. In this arrangement thehook 3170 includes abore 3172 which goes completely through thehook 3170. Both ends of the oval are oval or ob-round in order to allow thehook 3170 to pivot onshaft 3174.Shaft 3174 has a plurality of bores 3176 provided therethrough, any one of which can align with thebore 3178 which is provided across thebore 3172 of thehook 3170. When such an alignment is made a pin or screw can be inserted intobore 3178 in order to secure theshaft 3174 to thehub 3170. By selecting one of the several bores 3176 in theshaft 3174, the position of the hook relative to the hub can be adjusted in order to accommodate the shape and spacing of the various spinous processes. -
Embodiment 3100 can be implanted in a number of methods in accordance with the teachings for the implantation of theembodiment 2000. Preferably this would occur once a spine fixation device is implanted between the vertebral bodies in order to fuse together adjacent vertebral bodies. - In one preferred embodiment of implantation, in particular with respect to the embodiment of
FIG. 153 , the guide and sleeve or spacer can be inserted between adjacent spinous processes. Once this is accomplished, the hooks at the end of shafts could be positioned relative to thehub 3102 so that the hooks can grab about adjacent spinous processes. Once this has occurred, theshaft 3124 can be received in the lower portion of the hub. The upper portion of thehub 3105 can be mated with the lower portion in order (1) to capture and fixshaft 3124 in place, allowing for the movement of theshaft 3124, and also (2) to capture and fix theshaft 3110 in place to rigidly position theshaft 3110 relative to thehub 3102. - It is also to be understood that in other situations the fully assembled embodiment can be inserted in place relative to the adjacent spinous processes. Once this accomplished, a screw such as the screw in
FIG. 153 can be tightened in order to secure the various shafts relative to thehub 3102. - In all of the above procedures, and also in the procedures with respect to
prior embodiment 2000, it is advantageous that the embodiments can address the adjacent spinous processes from one side of the spinous processes and do not require exposure to both sides of the spinous processes. Thus, this procedure is less traumatic to the surgical site. - The embodiments depicted in
FIGS. 161 a to 163 c have some of the same functionalities, features, design characteristics, and materials as previously described in the embodiments depicted and described in FIGS. 1 to 129. FIGS. 1 to 129 are directed to spine distraction implants and methods used in distracting apart spinous processes in order to relieve pain associated with the spine such as, by way of example only, the pain associated with spinal stenosis. Accordingly, as appropriate, and even if not specifically mentioned in each inventive description ofFIGS. 161 a to 163 c, many of the design characteristics, features, functionalities, materials, measurements, dimensions, purposes, aspects, and objects of the devices in FIGS. 1 to 129 are applicable to the present invention. - An alternate embodiment of the implant of the invention is depicted in
FIGS. 161 a-163 c and designatedimplant 3200. Thisimplant 3200 is similar to prior implant with several different features. These additional features are depicted inFIGS. 161 a-163 c. In particular, inFIG. 161 a there is depicted a modified lead-in nose, guide ortissue expander 3202. In this particular embodiment, theguide 3202 is integrally formed with acentral body 3204 and thecentral body 3204 is secured by a number of devices including by threads to the main body or first wing units described with respect the prior embodiments. It is to be understood, however, that theguide 3202 can be secured to thecentral body 3204 by a variety of mechanisms including that of a thread bore. In reviewing all ofFIGS. 161 a to 161 e, is evident that theguide 3202 has anelliptical base 3206. Theguide 3202 progressively and somewhat elliptically is reduced in cross-sectional size from thebase 3206 to thetip 3208. In this particular embodiment, thetip 3208 is somewhat elongated. As can be seen inFIGS. 161 a, 161 c, the guide includes a threadedbore 3210 which receives a screw (not shown) which is used to affix a second wing as described in prior embodiments. - With respect to
FIG. 161 d, it is evident that thecentral body 3204 extends fromelliptical base 3206 from a point which is somewhat closer to end 3212 than to end 3214. The reason for this is to allow more of theflatter sides - Elliptical spacers associated with the
guide 3202 can come in a plurality of sizes. These include spacers with a minor diameter of 6 mm, 8 mm, 10 mm, and 12 mm. As appropriate, the implant can come in smaller and larger sizes. - With respect to
FIG. 161 e, in this particular embodiment, surface portion of theguide 3202 adjacent to thetip 3208 includesfiat surfaces elongated tip 3208 and assist in the insertion of theguide 3202 between the spinous processes by distracting and expanding the tissue between the spinous processes as the implant is positioned. -
FIG. 162 depicts an alternative embodiment of thesecond wing 3224 of the invention. In this embodiment, thesecond wing 3224 includes aconcave recess 3226 which is designed to fit over the elliptically shapednose 3202 and in this particular embodiment adjacent to theelliptical base 3206.Second wing 3224 includes aprojection 3228 which fits in to thegroove 3230 located above the threadedbore 3210 of theguide 3202. - A spacer or sleeve, not shown, associated with this embodiment can be elliptically shaped and about the same size as the
elliptical base 3206 of the lead-in guide ortissue expander 3202. Alternatively, as shown inFIG. 163 a, thespacer 3240 can be substantially egg-shaped with ablunt end 3242 and apointed end 3244. This egg-shapedspacer 3240 also includesflat side blunt end 3242 and thepointed end 3244. As can be seen toFIG. 163 a, thesleeve 3240 is positioned betweenspinous processes central bore 3254 upon which thesleeve 3240 rotates about the central body (shown in prior embodiments) is offset towards theblunt end 3242. This means that thepointed end 3244 can be positioned closer to the spine and adjacent to the portions of the spinous processes which are closer to the spine and which portions are stronger than more distally located portions of the spinous processes. In addition, theflat sides spacer 3240 more fully conform to the sides of thespinous processes spacer 3240 onto the adjacentspinous processes - With such an arrangement, in order to have a smooth transition between the sleeve and the lead-in guide or tissue expander, the base of the lead-in guide as previously shown in
FIG. 161 d is somewhat modified tobase 3256 of the guide as shown inFIG. 163 b. In this embodiment, thebase 3256 is also egg-shaped, conforming to the shape of thesleeve 3240. Further, thecentral body 3258 expending from thenose 3255 is off-centered toward theblunt end 3260 and away from thepointed end 3262, in order again to conform to the functionality of thesleeve 3240. - With such an arrangement, the method of implantation is similar to that of the other prior art described embodiments. However in this situation, due to the fact that the
bore 3254 of thesleeve 3240 is offset, the pointed end of thesleeve 3244 can be positioned close to the spine in order to contact stronger portions of the spinous processes with theflat sides spacer 3240. - Referring to
FIG. 164 , theimplant device 3300 has amain body 3301. Themain body 3301 includes aspacer 3302, afirst wing 3304, a tapered front end, lead-in guide ortissue expander 3320 and analignment track 3306. Themain body 3301 is inserted between adjacent spinous processes. Preferably, themain body 3301 remains safely and permanently in place without attachment to the bone or ligaments. All of the components of theimplant device 3300 are made of biologically acceptable material such as, but are not limited to, high strength titanium alloy or stainless steel. Preferably thefirst wing 3304 is laser welded to themain body 3301. - The tip of the
tissue expander 3320 has the smallest diameter, allowing the tip to be inserted into a small initial dilated opening. The diameter and/or cross-sectional areas of thetissue expander 3320 then gradually increases until it is substantially similar to the diameter of themain body 3301 andspacer 3302. The taperedfront end 3320 makes it easier for a physician to urge theimplant device 3300 between adjacent spinous processes. When urging themain body 3301 between adjacent spinous processes, thefront end 3320 distracts the adjacent spinous processes to the diameter of thespacer 3302. As shown inFIG. 164 , thetissue expander 3320 is a pyramid shape. In another embodiment the tissue expander preferably has an angle of twenty-five degrees that allows it to clear the facet. This reduces the length of thefront end 3320. One will appreciate that the shape of thetissue expander 3320 can be other shapes such as, but not limited to, cone shaped, or any other shape with a small lead-in cross-section expanding into a larger cross-section. These types of shapes gradually distract the spinous processes to a sufficient distance so that thespacer 3302 can conveniently fit between the spinous processes. - The
spacer 3302 can be made of stainless steel, titanium, a super-elastic material or silicone or other biologically acceptable material. The material can be rigid or resilient as desired. As shown inFIG. 164 , thespacer 3302 is an elliptically shaped cylinder. One will appreciate that the spacer can consist of other shapes such as, but not limited to, egg-shaped, round-shaped or saddle-shaped. For example, thespacer 3302 can be saddle-shaped along the surface which engages the spinous processes so that the high edges and the lower central portions can more fully accommodate the shape of the spinous processes. Preferably, thespacer 3302 can swivel, allowing thespacer 3302 to self-align relative to the uneven surface of the spinous process. This ensures that compressive loads are distributed equally on the surface of the bone. By way of example only, thespacer 3302 can have diameters of six millimeters, eight millimeters, ten millimeters, twelve millimeters and fourteen millimeters. These diameters refer to the height by which the spacer distracts and maintains apart the spinous process. Thus for an elliptical spacer the above selected height would represent the small diameter measurement from the center of the ellipse. The largest diameter would be transverse to the alignment, of the spinous process, one above the other. Smaller and larger diameters are within the scope of the invention. - The shape of the
spacer 3302 and for that matter the shape of the entire implant is such that for purposes of insertion between the spinous processes, the spinous processes do not need to be altered or cut away in any manner in order to accommodate theimplant 3300. Additionally, the associated ligaments do not need to be cut away and there would be very little or no damage to the other adjacent or surrounding tissues other than piercing through and separating, or dilating an opening in a ligament. - The
first wing 3304 has alower portion 3316 and anupper portion 3318. Theupper portion 3318 is designed to preferably accommodate, in this particular embodiment, the anatomical form or contour of the L4 (for an L4-L5 placement) or L5 (for an L5-S1 placement) vertebra. It is to be understood that the same shape or variations of this shape can be used to accommodate other vertebra. Thelower portion 3316 is also rounded to accommodate, in a preferred embodiment, the vertebra. Thelower portion 3316 andupper portion 3318 of thefirst wing 3304 will act as a stop mechanism when theimplant device 3300 is inserted between adjacent spinous processes. Theimplant device 3300 cannot be inserted beyond the surfaces of thefirst wing 3304. Additionally, once theimplant device 3300 is inserted, thefirst wing 3304 can prevent side-to-side, or posterior to anterior movement of theimplant device 3300. - The
implant device 3300 also has anadjustable wing 3310. Theadjustable wing 3310 has alower portion 3308 and anupper portion 3314. Similar to thefirst wing 3304, theadjustable wing 3310 is designed to accommodate the anatomical form or contour of the vertebra. - The
adjustable wing 3310 is secured to themain body 3301 with afastener 3322 provided through taperedcavity 3330. Theadjustable wing 3310 also has analignment tab 3312. When theadjustable wing 310 is initially placed on themain body 3301, thealignment tab 3312 engages thealignment track 3306. Thealignment tab 3312 slides within thealignment track 3306 and helps to maintain theadjustable wing 3310 substantially parallel with thefirst wing 3304 in this preferred embodiment. When themain body 3301 is inserted into the patient and theadjustable wing 3310 has been attached, theadjustable wing 3310 also can prevent side-to-side, or posterior to anterior movement. - Referring now to
FIG. 165 , theadjustable wing 3310 includes the above mentioned taperedcavity 3330. The taperedcavity 3330 has amiddle portion 3332, twoend portions 3334 and a tapered wall 3331. The diameter of themiddle portion 3332 is larger than the diameter of eitherend portion 3334. The tapered wall 3331 has a larger diameter at the top surface of theadjustable wing 3310 than at the bottom surface. Accordingly a cone-like shape is formed. When thefastener 322 engages the main body 301 and is rotated, thefastener 322 travels into the main body 301 (seeFIG. 164 ). As thefastener 3322 travels into themain body 3301, theadjustable wing 3310 will travel along thealignment track 3306 towards thefirst wing 3304. Thealignment tab 3312 engages the alignment track 306 and functions as a guide, keeping theadjustable wing 3310 and thefirst wing 3304 substantially parallel to each other. - The
fastener 3322 has a taperedhead 3323, amiddle section 3336 and threaded bottom section 3338 (seeFIG. 166 ). The top end of the taperedhead 3323 was a diameter substantially similar to the diameter of the top surface of the taperedcavity 3330. The diameter of the taperedhead 3323 is reduced as the tapered head meets themiddle section 3336. The slope of the taperedhead 3323 is similar to the slope of the taperedcavity 3330 of theadjustable wing 3310. Themiddle section 3336 has a diameter substantially similar to theend portions 3334 of theadjustable wing 3310. The threadedbottom section 3338 has a slightly larger diameter than themiddle section 3336 and is in one embodiment slightly smaller than the diameter of themiddle portion 3332 of theadjustable wing 3310. - As the diameter of the
end portions 3334 are smaller than the diameter of thebottom section 3338, thefastener 3322 cannot initially be placed through theend portions 3334 of theadjustable wing 3310. Accordingly, to fasten theadjustable wing 3310 to themain body 3301, the threadedbottom section 3338 of thefastener 3322 is placed through themiddle portion 3332 of theadjustable wing 3310 and into themain body 3301. With a turn of thefastener 3322, the threaded portion of thebottom section 3338 will engage themain body 3301. - In another preferred embodiment the diameter of threaded
bottom section 3338 is larger than the diameter of the middle portion of theadjustable wing 3310. For this embodiment, thefasteners 3322 is inserted into thecavity 3330 by slicing the cavity 3330 (FIG. 165 ) through the thinnest portion of the wall, spreading the wall open, inserting themiddle section 3336 in the cavity with the threadedbottom section 3338 projection below thecavity 3330, and laser welding the wall closed. The slicing step preferably includes using a carbide slicing device. - When the
adjustable wing 3310 is in the position furthest from the position of thefirst wing 3304, the taperedhead 3323 of thefastener 3322 is substantially out of, and not engaging, the taperedcavity 3330 of the adjustable wing 3310 (SeeFIG. 167 ). As thefastener 3322 is rotated, thefastener 3322 will continue to engage, and travel further into, themain body 3301. As thefastener 3322 travels downwardly into themain body 3301, the taperedhead 3323 of thefastener 3322 contacts the wall 3331 of the taperedcavity 3330. Theadjustable wing 3310 can freely slide back and forth, limited by theend portions 3334 of the taperedcavity 3330. When the taperedhead 3323 contacts the wall 3331 of the taperedcavity 3330, theadjustable wing 3310 moves towards thefirst wing 3304 guided by thealignment tab 3312 in thealignment track 3306. Therefore, theadjustable wing 3310 remains substantially parallel to thefirst wing 3304 in this preferred embodiment as theadjustable wing 3310 moves toward the first wing 3304 (seeFIG. 168 ). It is to be understood that thetab 3312 and thetrack 3306 can be eliminated in another embodiment of the invention. - As shown in
FIG. 168 , the tapered head of 3323 of thefastener 3322 is mated in the tapered wall 3331 of theadjustable wing 3310. Accordingly, with this ramp mechanism, theadjustable wing 3310 is urged toward the spinous processes and thefirst wing 3304 and is locked in position at its closest approach to thefirst wing 3304. This arrangement allows the surgeon to loosely assemble the implant in the patient and then urge the adjustable wing closer to the first wing, by rotatingfastener 3322 intobody 3310 making the implanting method more tolerant to the anatomy of the patient. - The structure of the spine is of course unique for every patient. Accordingly if the width of the spinous processes is excessive, the adjustable wing can be left in a position that is between that shown in
FIG. 167 and that shown inFIG. 168 . The separation between thefirst wing 3304 and theadjustable wing 3310 can be incrementally adjusted by the number of turns of thefastener 3322. -
FIGS. 169 and 170 illustrate the position of theimplant device 3300 in a patient. As shown byFIG. 169 , thelower portion 3316 andupper portion 3318 of thefirst wing 3304 function to prevent side-to-side movement, toward and away from the vertebral body ensuring that theimplant device 3300 remains in place. Similarly, theadjustable wing 3310 will also prevent excessive side-to-side movement. The wing also prevents motion in the direction of the main body into the space between the spinous processes. - An embodiment of the
implant 4100 is depicted inFIGS. 171 a, 171 b and 171 c. This implant includes thefirst wing 4104 andsleeve 4116 and a lead-in anddistraction guide 4110. This embodiment further includes, as required, asecond wing 4132 as depicted inFIGS. 171 d and 171 e. As can be seen inFIG. 171 a, acentral body 4102 extends from thefirst wing 4104. Also, as can be seen inFIGS. 171 a and 171 b, theguide 4110 in this particular embodiment is pointed in order to allow the implant to be inserted between, and if necessary distract, adjacent spinous processes. - Additionally, as can be seen in
FIGS. 171 a, 171 f and 171 g, thesleeve 4116 is preferably cylindrical, and oval or elliptical in shape in cross-section. It is to be understood thatsleeve 4116 can have other shapes as described throughout the specification and be within the spirit and scope of the invention.Sleeve 4116 includes acentral bore 4119 which extends the length ofsleeve 4116. Thesleeve 4116 is received over thecentral body 4102 of theimplant 4100 and can rotate thereon about the central body 102. In these embodiments, thespacer 4116 can preferably have minor and major dimensions as follows:Minor Dimension (4116a) Major Dimension (4116b) 6 mm 10 mm 8 mm 10.75 mm 12 mm 14 mm 6 mm 12.5 mm 8 mm 12.5 mm 10 mm 12.5 mm - In another preferred embodiment, the
spacer 4116 has a cross-section with a major dimension and a minor dimension and the major dimension is greater than the minor dimension and less than about two times the minor dimension. - It is to be understood that the sleeve can be comprised of biologically acceptable material such as titanium or stainless steel. Additionally, it can be comprised of super-elastic material such as an alloy of nickel and titanium. Other structural and material variations for the sleeve are described below.
- The advantage of the use of the
sleeve 4116 as depicted in the embodiment ofFIG. 171 a is that the sleeve can be rotated and repositioned with respect to thefirst wing 4104, in the embodiment, in order to more optimally position theimplant 4100 between spinous processes. It is to be understood that the cortical bone or the outer shell of the spinous processes is stronger at an anterior position adjacent to the vertebral bodies of the vertebra than at a posterior position distally located from the vertebral bodies. Accordingly, there is some advantage of having theimplant 4100 placed as close to the vertebral bodies as is possible. In order to facilitate this and to accommodate the anatomical form of the bone structures, as the implant is inserted between the vertebral bodies and urged toward the vertebral bodies, thesleeve 4116 can be rotated relative to the wings, such aswing 4104, so that the sleeve is optimally positioned between the spinous processes, and thewing 4104 is optimally positioned relative to the spinous processes. Without this capability, depending on the anatomical form of the bones, it is possible for the wings to become somewhat less than optimally positioned relative to the spinous processes. - As required, the
implant 4100 can also include asecond wing 4132 which fits over theguide 4110 and is preferably secured by a bolt through apparatus 4134 ofsecond wing 4132 to the threadedbore 4112 located inguide 4110. As implanted, thefirst wing 4104 is located next to the adjacent first side of the spinous processes and thesecond wing 4132 is located adjacent to second side of the same spinous processes. - Referring now to
FIGS. 172-178 , various embodiments of spacers adapted for placing between thefirst wing 4104 and thesecond wing 4132 are shown. The preferred material for the various spacers described below is titanium in combination with a deformable material such as silicone. It is within the scope of the present invention to manufacture the spacers from other biologically acceptable material such as, by way of example only, stainless steel or an alloy of nickel and titanium along with another deformable material such as another deformable polymer. - Turning now to
FIG. 172 , thespacer 4200 includes anouter shell 4202. Theouter shell 4202 is integrally formed with thecenter shaft 4206 by two support columns 4204. The center shaft has abore 4208 extending through. Each support column 4204 extends substantially perpendicular from thecenter shaft 4206. Between theouter shell 4202 and thecenter shaft 4206, a cavity 4205 is created. - The shape of the
outer shell 4202 as shown inFIG. 172 is elliptical in shape. It is within the scope of the invention that theouter shell 4202 may comprise other shapes such as, but not limited to, a cylindrical or egg shape. Regardless of the shape, theouter shell 4202 is not continuous in this preferred embodiment. One half of theouter shell 4202 extends from the end of onesupport column 4204 a and around thecenter shaft 206 until theouter shell 4202 almost reaches thesecond support column 4204 b. The second half of theouter shell 4202 is the same as the first half, and in this case both halves extend in a clockwise direction. Since each half of theouter shell 4202 extends from a different support column 4204, twoslots slots spacer 4200. The slots 4210 function to lower the rigidity of theouter shell 4202 so that theouter shell 4202 is more flexible and functions as a cantilever spring. The smallest diameter of the space (circular or elliptical) can preferably range from 6 mm. to 11 mm. The thickness of the outer shell can preferably be 2 mm. The spacer can have other dimensions as identified previously. - Preferably, a compressible substance 4207 is placed into the
cavities outer shell 4202 and thecenter shaft 4206. The compressible substance 4207 provides resistance against theouter shell 4202 traveling towards thecenter shaft 4206. As previously mentioned, the compressible substance in this embodiment is preferably silicone. It is within the scope of the invention that the compressible substance 4207 may comprise another medium such as, but not limited to, urethane-coated silicone and/or co-formed with silicone so that the urethane will not be attacked by the body, or another ultra-high molecular weight polymer. Another preferred material is polycarbonate-urethane, a thermoplastic elastomer formed as the reaction product of a hydroxl terminated polycarbonate, an aromatic diisocyanate, and a low molecular weight glycol used as a chain extender. A preferred polycarbonate glycol intermediate, poly(1,6-hexyl 1,2-ethyl carbonate)diol, PHECD, is the condensation product of 1,6-hexanediol with cyclic ethylene carbonate. The polycarbonate macroglycol is reacted with aromatic isocyanate, 4,4′-methylene bisphenyl diisocyanate (MDI), and chain material is preferable used at a hardness of 55 durometer. This material, as well as the other materials, can be used in the other embodiments of the invention. - The compressible medium preferably has a graduated stiffness to help gradually distribute the load when a spinous processes places a force upon the
outer shell 4202. For example, the hardness of the silicone can be the lowest where the silicone contacts theouter shell 4202, and the hardness of the silicone can be the highest where the silicone contacts thecenter shaft 4206. Alternatively, the silicone can have a higher hardness in the center of the silicone located between theouter shell 4202 and thecenter shaft 4206. - The compressible medium 4207 fills the cavity between the
outer shell 4202 and thecenter shaft 206 and is flush with theouter shell 4202. When thespacer 4200 is inserted between adjacent spinous processes, theouter shell 4202 protects the compressible substance (e.g., silicone) from directly contacting the spinous processes because the slots 4210 are along the side of thespacer 4200. Therefore, the deformable material 4207 does contact the spinous processes and wear debris is reduced or eliminated. - It is to be understood that for this and also in the embodiments in
FIGS. 173, 175 a and 175 b, the embodiment can be constructed without a compressible material, with the outer shell solely providing the flexibility of the spacer. It is also to be understood that the embodiments shown inFIGS. 173-178 can have the dimensions and be made of the materials similar to those ofFIG. 172 . It is additionally to be understood that the metal components of any of the embodiments hereof can be comprised of a suitable plastic or composite material including fibers for strength. - Now referring to
FIG. 173 , thespacer 4300 has anouter shell 4302 and acenter shaft 4306. Thecenter shaft 4306 has abore 4308 extending through. Thecenter shaft 4306 is connected with theouter shell 4302 by twosupport columns 4304 a,b, with eachsupport column 4304 a,b located on opposite sides of the center shaft 306. Similar to the embodiment of the present invention as illustrated inFIG. 172 , theouter shell 4302 is elliptical, yet may comprise other shapes such as, but not limited to, a cylindrical or egg shape. - The
outer shell 4302 has twoslots 4310 a,b. Theslots 4310 a,b extend through the wall of theouter shell 4302 to form a rectangular-like opening. It is within the scope of the invention for thespacer 4300 to have more than two slots 4310 and with different shapes. Theslots 4310 a,b are used to make theouter shell 4302 more flexible. It is preferred that theslots 4310 a,b are located on the sides of thespacer 4300 so that none of theslots 4310 a,b contact a spinous process. - Between the
outer shell 4302 and thecenter shaft 4306 are twocavities 4305 a,b. These cavities are separated by thesupport columns 4304 a,b. The two cavities created between theouter shell 4302 and thecenter shaft 4306 preferably have a compressible substance therein. As previously mentioned, the compressible substance is preferably silicone. To improve the load distribution upon theouter shell 4302 and ease the load on the spinous processes, the silicone can have a graduated stiffness. For example, the hardness of the silicone can be the lowest where theouter shell 4302 contacts the silicone, and the hardness of the silicone can be the highest where thecenter shaft 4306 and the support column 4304 contacts the silicone. Alternatively, the silicone can have a higher hardness in the center of the silicone riding between theouter shell 4302 and thecenter shaft 4306. - The silicone is placed between the
outer shell 4302 and thecenter shaft 4306 so that the silicone extends into the slots 4310 and is flush with theouter shell 4302. Since the spinous processes do not directly contact the silicone, this embodiment of the present invention also helps prevent wear debris. - Referring now to
FIG. 174 , yet another embodiment of the present invention includesspacer 4400. Thespacer 4400 has anouter shell 4402 and acenter shaft 4406. Thecenter shaft 4406 has abore 4408 extending through. Thespacer 4400 has twoopenings 4410 a,b that are substantially along the top 4111 and bottom 4113 portions of theouter shell 4402. Between theouter shell 4402 and thecenter shaft 4406,cavities 4405 a,b are created which connects the twoopenings 4410 a,b. - Similar to the previous embodiments, a compressible medium such as silicone is placed into the
cavity 4405 a,b andopenings 4410 a,b until the silicone becomes flush with theouter shell 4402. Preferably, the silicone also has a graduated stiffness. For example, the hardness of the silicone can be the lowest where it is flush with theouter shell 4402, and can be the highest where the silicone contacts thecenter shaft 4406. Unlike the previous embodiments, the exposed silicone will directly contact the spinous processes. - Referring now to
FIGS. 175 a-175 b, another embodiment of the invention isspacer 4500. Thespacer 4500 has anouter shell 4502 and acenter shaft 4506. Theouter shell 4502 forms a “C”-like shape. Thecenter shaft 4506 has abore 4508 extending through. Thecenter shaft 4506 is attached to theouter shell 4502 by asupport 4504. Thesupport 4504 is substantially horizontal extending from the vertical center of the “C” to the middle of theopen end 4509. Theouter shell 4502 defines twoslots 4510 a,b along the length of theopen end 4509. Bothslots 4510 a,b are defined by the space between thesupport 4504 and each end portion of theouter shell 4502. Since theouter shell 4502 is fixed at one end only, theouter shell 4502 functions like a cantilever-type spring. Theouter shell 4502 is shown as elliptical in shape. It is within the scope of the present invention that thespacer 4500 may comprise other shapes such as, but not limited to, a cylindrical or egg shape. - The
support 4504 has preferably at least two protrusions such as protrusions selected fromprotrusions 4512 a,b,c,d. For example, thespacer 4500 inFIGS. 175 a,b has fourprotrusions 4512 a,b,c,d. Eachprotrusion 4512 a,b,c,d extends substantially and preferably perpendicular in this embodiment from thesupport 4504 towards the inner surface of theouter shell 4502. While thespacer 4500 is in anon-compressed state, there is a gap between eachprotrusion 4512 a,b,c,d and theouter shell 4502. When thespacer 4500 is compressed, theprotrusions 4512 a,b,c,d function to restrict the deflection of theouter shell 4502. When a spinous process exerts a force upon theouter shell 4502, theouter shell 4502 will deflect toward thecenter shaft 4506 until theouter shell 4502 contacts theprotrusion 4512 a,b,c,d. Essentially, theprotrusions 4512 a,b,c,d, function as a stop mechanism preventing theouter shell 4502 from deflecting too much, and thus limiting the motion of the spinous processes. - Similar to the previous embodiments,
cavities 4505 a,b are formed between thecenter shaft 4506 and theouter shell 4502. A compressible substance such as silicone is placed within thecavity 4505. It is preferable that the silicone have a graduated stiffness to help distribute the load placed upon theouter shell 4502. For example, the hardness of the silicone can be the lowest where the silicone contacts the inner surface of theouter shell 4502, and the hardness of the silicone can be the highest where the silicone contacts thecenter support shaft 4506, and thesupport 4504 and theprotrusions 4512 a,b,c,d. Alternatively, the silicone can have a higher hardness in the center of the silicone rising between theouter shell 4502 and thecenter shaft 4506. - The silicone fills the
cavities 4505 a,b until the silicone is flush with theouter shell 4502. When thespacer 4500 is inserted between adjacent spinous processes, the top andbottom portions spacer 4500 contact the spinous process. Therefore, the silicone will not directly contact the spinous processes which aids in the prevention of wear debris. - Referring now to
FIGS. 176 a-176 c, another embodiment of the present invention is spacer 4600. The spacer 4600 has a firstouter shell 4602 and a secondouter shell 4603. The firstouter shell 4602 has at least twosupport elements 4604 a,b. Eachsupport element 4604 a,b has abore 4605 a,b extending therethrough. Thesupport elements 4604 a,b are located substantially at either end of the firstouter shell 4602 along a single horizontal axis. Thebores 4605 a,b are oval in a preferred embodiment. This shape allows the spacer 4600 to move relative to the central shaft or axis (FIG. 117 ) upon which the spacer is mounted. The secondouter shell 4603 has asingle support element 4606, located substantially in the center of the secondouter shell 4603 and along the same horizontal axis as the twosupport elements 4604 a,b. Thesupport element 4606 also has a bore extending through which is similar to bore 4605.Support element 4606 is located betweensupport element 4604 a,b inFIG. 176 a. A central shaft 4612 (shaft 4102 inFIG. 171 c) is placed through thesupport elements 4604 a,b, 4606 to form a hinge-type connection between the firstouter shell 4602 and the second outer shell 4603 (seeFIG. 176 a). The hinge-type connection allows the firstouter shell 4602 and the secondouter shell 4603 to move independently of each other. - When the first
outer shell 4602 and the second outer shell 603 are connected byshaft 4612,slots 4610 a,b are created along the side edges of the spacer 4600. Twocavities 4614 a,b are also created, defined by the hinge-type connection between the firstouter shell 4602 and the secondouter shell 4603. Similar to the previous embodiments, a compressible substance (e.g., silicone) can fill each cavity and extend into theslots 4610 a,b until the silicone is flush with the firstouter shell 4602 and the secondouter shell 4603. Additionally, it is preferred that the silicone have a graduate hardness similar to the previous embodiments. In one embodiment, the hardness of the silicone can be the highest along view line A-A, and can be the lowest where the silicone contacts the first and secondouter shell support elements 4604 a,b, 4606, and can have the lowest hardness where the silicone fills theslots 4610 a,b. - When the spacer 4600 is inserted between adjacent spinous process, only the top and
bottom portions outer shell 4602 and the secondouter shell 4603 prevent direct contact between the silicone and the spinous process. Accordingly, the spacer 4600 helps prevent wear debris from being formed. - Now referring to
FIG. 177 , still yet another embodiment of the present invention isspacer 4700.Spacer 4700 includes preferably a component in the shape of an elliptical or oval or cylindrical spool 4710. Alternatively, thecomponent 4700 can be formed for method or suitable plastic material or composites including, by way of example only, fibers for strength. Thespacer 4700 has acenter shaft 4702 with abore 4708 extending through. As in other embodiments, thebore 4708 can be, by way of example only, circular, oval or elliptical. Afirst end 4704 and asecond end 4706 are integrally formed with thecenter shaft 4702 in this preferred embodiment. Both thefirst end 4704 and thesecond end 4706 extend outward from thecenter shaft 4702 and form a circular rim around each end of thecenter shaft 4702. It is within the scope of the present invention for thefirst end 4704 andsecond end 4706 to comprise other shapes such as, but not limited to, elliptical, circular, oval or egg-shaped. - A compressible medium 4712 surrounds the
center shaft 4702. As previously mentioned, the compressible substance is preferably silicone. The silicone extends out from thecenter shaft 4702 until it is flush with the outer rim of both thefirst end 4704 and thesecond end 4706. With the silicone around thecenter shaft 4702, thespacer 4700 will look like an elliptical cylinder in this embodiment. Thespacer 4700 does not have an outer shell surrounding the silicone. When thespacer 4700 is inserted between adjacent spinous process, the silicone will directly contact the spinous process. A preferred embodiment of thespacer 4700 will have silicone with a graduated stiffness to help distribute the load placed upon thespacer 4700. For example, the hardness of the silicone can be the lowest at the outermost surface that contacts the spinous process, and the hardness of the silicone can be the highest where the silicone surrounds and contacts thecenter shaft 4702. Alternatively the hardness can be greater where the silicone contacts the spinous process and then less hard adjacent to thecenter shaft 4702. - Now turning to
FIG. 178 a, another embodiment of the present invention isspacer 4800. Thespacer 4800 has anouter shell 4802 which can be metallic or plastic. Theouter shell 4802 is preferably elliptical in shape. It is within the scope of the present invention that theouter shell 4802 can be a shape such as, but not limited to, a cylindrical or egg shape. Regardless of the shape, theouter shell 4802 is open on bothends - A
compressible substance 4804 is placed within theouter shell 4802 and is flush with bothends outer shell 4802. Abore 4806 extends through thecompressible substance 4804. If desired the bore can be defined by a metallic or plastic sleeve held on thecompressible substance 4804. Similar to the previous embodiments, thecompressible substance 4804 is preferably silicone. A preferred embodiment of thespacer 4800 has silicone with a graduated stiffness. In an embodiment, the hardness of the silicone can be the highest at thebore 4806, and the hardness of the silicone can be the lowest where the silicone contacts the inner surface of theouter shell 4802. Alternatively, the hardness of the silicone can be the highest adjacent shell and lowest aboutbore 4806. - When the
spacer 4800 is inserted between adjacent spinous processes, only the top andbottom portions outer shell 4802 prevents direct contact between the silicone and the spinous processes. Accordingly, thespacer 4800 helps prevent wear debris from being formed. - By way of example only, the thickness of the outer shell can be about 0.010 inches with the hardness of the compressible medium being about 50 durometer. By way of example only, the outer shell can be about 0.010 inches with the hardness of the compressible medium being about 70 durometer.
- It is also to be understood that the
spacer 4800 can include any of the compressible medium 4804 discussed herein and/or compatible with the body, with a bore hole provided therethrough. That is to say that theouter shell 4802 can be eliminated in this embodiment. Preferably the spacer is comprised of silicone, however, other materials are within the spirit and scope of the invention.FIG. 178 b depicts an egg-shapedspacer 4800′ with abore 4806′. Thespacer 4800′ is comprised of a compressible medium. - Referring now to
FIGS. 179 a-179 b, the interspinous process device onimplant 4900 has afirst support 4902 and asecond support 4904. Thefirst support 4902 and thesecond support 4904 directly contact the spinous process and can be made of a suitable metal or a suitable plastic. Both thefirst support 4902 and thesecond support 4904 have acontour 4903. Thecontour 4903 allows thedevice 4900 to be contoured to and to engage each spinous process so, preferably, that thedevice 4900 does not move laterally. Eachcontour 4903 includes aconcave portion 4920 andupstanding ridges FIG. 179 a in order to define a deeper contour. Additionally,ridges 4924, especially when higher, ofsupports ridges 4922, especially when higher, ofsupport - During the method of implanting
device 4900, both spinous processes are exposed using appropriate surgical techniques, and thereafter thedevice 4900 is positioned so that thesaddles 4903 of both thefirst support 4902 and thesecond support 4904 engage the respective spinous process. The concave shape of the saddle 903 distributes the forces between thesaddle 4903 and the respective spinous process. This ensures that the bone is not reabsorbed due to the placement of thedevice 4900 and that the structural integrity of the bone is maintained. - Referring now to
FIG. 179 b, thefirst support 4902 has afemale receiving mechanism 4906 and thesecond support 4904 has amale engaging mechanism 4908. The width of thefemale receiving mechanism 906 and themale engaging mechanism 4908 are substantially similar. Thefemale receiving mechanism 4906 further has analignment column 4905 to assist in the movement of thesupports - The
first support 4902 and thesecond support 4904 are interlocked so that thefirst support 4902 and thesecond support 4904 cannot be independently separated. Thefirst support 4902 has aledge 4907 that extends around the inner circumference of thefirst support 4902. Similarly, thesecond support 4904 has aledge 4909 extending around the circumference of themale engaging mechanism 4908. If thefirst support 4902 and thesecond support 4904 travel in opposite directions, theledges first support 4902 and thesecond support 4904 from separating. Preventing the first support 9402 and thesecond support 4904 from separating also contains the compressible medium 4910, as described below, within thedevice 4900. - Placed within the
female receiving mechanism 4906 is acompressible medium 4910. As previously mentioned the compressible medium 4910 provides resistance, limiting the possible range of motion of the spinous process. By way of example only, the compressible medium 4910 can be silicone. It is within the scope of the present invention that the compressible medium can include, by way of example only, a spring mechanism, a synthetic gel or a hydrogel. The compressible or deformable material can also include material which offers, for example, increased resistance to compression the more the material is compressed. For example, as compression and deformation occur, the material can offer a steady resistive force or a resistance force that increases, either linearly or non-linearly, the more the implant is compressed. - With respect to an embodiment with a graduated stiffness, the hardness of the silicone can be the lowest where the
first support 4902 contacts the silicone, and the hardness of thesilicone 4910 can be the highest where thesecond support 4904 contacts the silicone. Alternatively, the silicone can have a higher hardness in the center of the silicone riding between thesupports - In this and with the other embodiments, the medium 4910 can also be designed to vary resistance to movement according to the speed or rate of deformation. For example, when an individual leans back slowly, the adjacent spinous processes place a force onto the
first support 4902 and thesecond support 4904. With slow backward bending the force is small and gradual until the limit of compression of the material is reached. However, if the individual attempts a rapid activity that can result in a severe first compression of thedevice 4900, the medium 4910 can offer higher stiffness, preventing the spinous processes from making excessive motion and causing pain. - Preferably, the height of the
device 4900 is slightly larger than the undistracted distance between the adjacent spinous processes. When thedevice 4900 is then inserted between the spinous process, thecontours 4903 will press against each spinous process and assist to keep thedevice 4900 in place. During a daily routine, an individual will perform functions that will translate into vertical movement of each spinous process. It is important that the individual be able to retain some of his normal range of motion. To retain a normal range of motion, thedevice 4900 can preferably be compressed when the spinous processes place a force upon thefirst support 4902 and thesecond support 4904. Thus, when thedevice 4900 is in a normal state the outerperipheral edge second support ridges amount device 4900 can be compressed. Such an arrangement reduces potential resorption of the bone adjacent to the implant and to more gradually limit extension or backward bending of the spinal column. - The embodiment of this implant as well as the several other implants described herein act to limit extension. These implants, however, do not inhibit the flexion of the spinal column when the spinal column is bent forward.
- This invention includes instruments and methods for inserting spinal implants in the vertebral columns of patients and to spinal implants themselves. In one embodiment, instruments are provided for inserting a main body assembly between spinous processes of adjacent vertebrae. These instruments, termed herein “main body insertion instruments” generally comprise an elongated body portion having a handle at one end, an insertion shaft and an insertion tip. The insertion tip engages with the main body assembly and holds the assembly in fixed relation to the instrument. The surgeon prepares the site for implantation, and uses the instrument to urge the assembly between spinous processes of adjacent vertebrae.
- In other embodiments of this invention, different instruments can be used to insert universal wings on to the main body assembly of the spinal implant. These other instruments are termed herein “wing insertion instruments.” A wing insertion instrument generally comprises a handle, an insertion shaft and an insertion tip. The insertion tip of a wing insertion instrument engages with the universal wing and holds it fixed relative to the instrument. The surgeon then grasps the handle portion of the instrument and uses it to urge the wing implant portion into proximity with a main body assembly which has been inserted between spinous processes of the spine.
- I. Main Body Insertion Instrument
- Main body insertion instrument of this invention is illustrated, by way of example only, in
FIGS. 180-182 .FIG. 180 depicts an exterior view of a mainbody insertion instrument 5100 of this invention having ahandle 5010, aninsertion shaft 5020 and aninsertion tip 5030.Handle 5010 can be made of any suitable material, such as by way of example only, Gray ULTEM™, a polyetherimide resin.Insertion shaft 5020 can be made of any suitable, strong material, such as 304 stainless steel.Insertion shaft 5020 has a central bore extending through its length. The proximal end ofinsertion shaft 5020 is adapted to fit within the distal end ofhandle 5010, and can be held in place with a set screw, made of, by way of example only, 304 or 455 stainless steel. A mainbody insertion tip 5030 is attached to the distal end of the insertion shaft.Insertion tip 5030 can be made of, by way of example only, 17-4 stainless steel. A bore extends longitudinally through theinsertion tip 5030 and is contiguous with the bore through theinsertion shaft 5020. Aninsertion rod 5040, having a distal end with a spacer engagement pin and a locking pin, extends through the length of the bore ininsertion shaft 5020.Insertion rod 5040 extends into thehandle 5010 of the mainbody insertion instrument 5100. On one side ofhandle 5010,insertion knob 5110, having a raisedportion 5112, is for manipulation of a locking pin and spacer engagement pin ininsertion tip 5030. Theinsertion knob 5110 can be made of, by way of example only, 304 stainless steel. The stainless steel components of the instruments of this invention can desirably meet ASTM Standard F899-95: Standard Specifications for Stainless Steel Billet, Bar, and Wire for Surgical Instruments. -
FIG. 181 depicts a longitudinal cross-sectional view of a mainbody insertion instrument 5100 as depicted inFIG. 180 , and shows details of this embodiment of the invention.Handle 5010 has aninsertion knob groove 5105 on a lateral surface, within whichinsertion knob 5110 is provided.Insertion knob 5110 andgroove 5105 are sized so thatinsertion knob 5110 can move in a proximal/distal path along thehandle 5010.Insertion knob 5110 has said raisedportion 5112 used for applying force to moveinsertion knob 5110 proximally and distally alonghandle 5010.Insertion knob 5110 is attached torod 5111, which is located withincavity 5121 of thecavity 5121. When placed withincavity 5121, therod 5111 engagesspring 5125, which is located within aninterior space 5124 ofhandle 5010.Spring 5125 is urged againstinsertion rod 5040. Thespring 5125 provides a force that urgesrod 5111 and alsorod 5040 toward the distal portion of theinstrument 5100.Spring 5125 is compressed by manual movement ofinsertion knob 5110 in a proximal direction, acting viarod 5111. Becauseinsertion rod 5040 is engaged withrod 5111,insertion rod 5040 is drawn proximally by proximal movement ofinsertion knob 5110. When manual force oninsertion knob 5110 is relaxed, as for example, after alignment of a main body implant in relation toinsertion tip 5030,spring 5125 urgesrod 5111,insertion rod 5040 andinsertion knob 5110 in a distal direction. Asinsertion rod 5040 is urged distally, lockingpin 5155 andspacer engagement pin 5157 are urged toward the distal end ofinsertion instrument 5100 as well, wherepins FIG. 181 depictsinsertion shaft 5020 having a proximal end that is adapted to fit within the distal portion ofhandle 5010. When so placed, setscrew 5130 engages withinsertion shaft 5020 to keepinsertion shaft 5020 engaged inhandle 5010.Set screw 5130 can be made of any convenient material, such as, by way of example only, stainless steel. It can be especially desirable forset screws handle 5010, to provide open access to the interior ofhandle 5010 for cleaning and sterilization -
Insertion tip 5030 is adapted to fit onto the distal end ofinsertion shaft 5020, byway of example only, with an interference fit.FIG. 181 depicts such an interference fit engagement ofinsertion tip 5030 with the distal end ofinsertion shaft 5020. However, other ways of attachinginsertion tip 5030 toinsertion shaft 5020 are contemplated and are considered to be part of this invention. -
FIG. 181 depicts components ofinsertion tip 5030, which include aproximal portion 5145, which can act as a position stop forspacer engagement pin 5157.Spacer engagement pin 5157 protrudes laterally from the portion of theinsertion rod 5040, and is adapted to engage a spacer engagement hole of a main body assembly. When so engaged,spacer engagement pin 5157 can position a spacer relative to the remainder of the main body wing and tissue expander, making insertion of the implant between spinous processes convenient. At the distal end ofinsertion rod 5040, lockingpin 5155 is positioned to engage a hole in the main body assembly. Thus, when so engaged,locking pin 5155 andspacer engagement pin 5157 can hold the main body, tissue expander and spacer in position relative to one another for convenient insertion. At the distal end of theinsertion tip 5030,portion 5147, having a flatmedial surface 5165, can support the main body. In some embodiments, one ormore alignment pins 5160 can be provided to engage with a main body to provide additional support during surgery. - In general, the construction of main
body insertion instrument 5100 desirably is sufficiently robust to provide firm support of the main body assembly during surgery. For example, in certain situations, it can be desirable for the surgeon to exert relatively large forces on the main body assembly to urge the tissue expander between spinous processes. Generally, the connective tissue, including ligaments, can be strong and tough, tending to resist stretching. However, during surgery using the spinal implants and insertion instruments of this invention, it may be desirable to deflect, distract and/or stretch the ligaments to permit passage and proper location of spinal implants. In these situations, the instruments are strong and rigid. - It also can be desirable for the surfaces to be smooth and have relatively simple geometrical shape. Simple shape and relatively open construction can provide for easy access to the interior of the parts of the instrument, and can permit easy and convenient cleaning and sterilization.
-
FIG. 182 a-182 c depict theinsertion tip 5030 of main bodyimplant insertion instrument 5100 in additional detail.FIG. 182 a depicts a side view ofinsertion tip 5030 fitted into the distal end ofinsertion shaft 5020.Bore 5150 ofinsertion shaft 5020 is shown in dashed lines. Lockingpin 5155 ofinsertion rod 5040 is shown in the distal-most extension, as urged byspring 5125 ofFIG. 181 .Portion 5147 is shown havingalignment pin 5160 with an axis aligned substantially perpendicularly to the plane ofportion 5147. Spacer engagement pin or catch 5157 is shown above lockingpin 5155. At its distal-most extension, lockingpin 5155 crosses the axis ofalignment pin 5160. Whenalignment pin 5160 andspacer engagement pin 5157 have engaged their respective portions of a main body assembly, the assembly can be firmly held by theinsertion tip 5030. -
FIG. 182 b depicts an insertion tip as shown inFIG. 182 a in which theinsertion rod 5040 has been moved to a proximal position. In the embodiment depicted inFIG. 182 b, lockingpin 5155 andspacer engagement pin 5157 have been retracted sufficiently to be proximal tosurface 5156 ofinsertion tip 5030. When so positioned, the main body assembly can be disengaged frominsertion tip 5030 and the instrument can be withdrawn from the patient's body, leaving the main body assembly in place. -
FIG. 182 c depicts a top view ofinsertion tip 5030.Insertion rod 5040 is shown in the retracted position, with lockingpin 5155 andspacer engagement pin 5157 being located proximally to surface 5156 ofinsertion tip 5030. Twoalignment pins 5160 are shown. When engaged with a main body assembly,flat surfaces pin 5155 andspacer engagement pin 5157 of theinstrument 5100 can hold the main body assembly firmly to the insertion instrument. -
FIGS. 183 a-183 c depict the method of engagement of a main body insertion instrument of the invention with a main body assembly of the invention. -
FIG. 183 a depicts amain body assembly 5400 of the invention for use with theinstrument 5100 of this invention.Main body assembly 5400 has amain body wing 5401 having acephalad wing member 5402 and acaudal wing member 5402 a.Cephalad wing member 5402, after insertion, is aligned toward the head of the subject along the right side of a dorsal spinous process.Member 5402 a is also positioned along the side of a spinous process.Main body wing 5401 also can have one ormore holes 5403 adapted to receivealignment pins 5160 of mainbody insertion instrument 5100.Main body wing 5401 also has lockingpin hole 5404 adapted to receivelocking pin 5155 of mainbody insertion instrument 5100.Main body wing 5401 is attached tospacer 5405, which hasspacer engagement hole 5406 adapted to receivespacer engagement pin 5157 ofinsertion instrument 5100. On the other end ofspacer 5405,tissue expander 5407 is shown, having a threadedhole 5408 adapted to receive a bolt of a universal wing implant (described below).Tissue expander 5407 has a tapered left end to ease insertion of the main body assembly between spinous processes. -
FIG. 183 b depicts a lateral view showing the points of engagement between a main body assembly and main body insertion instrument.Insertion rod 5040 of insertion instrument is shown in a retracted, or proximal position. Lockingpin 5155 andspacer engagement pin 5157 are shown aligned proximally to plane 5156 ofinsertion tip 5030.Spacer engagement pin 5157 is adapted to engage with spacer engagement hole 406, lockingpin 5155 is adapted to engage with lockingpin hole 5404, andalignment pin 5160 is adapted to engage withalignment hole 5403. -
FIG. 183 c depicts main body insertion instrument engaged with main body assembly. Whileinsertion rod 5040, lockingpin 5155 andspacer engagement pin 5157 are in the retracted position, a main body assembly has been positioned withalignment pin 5160 received intoalignment pin hole 5403. Thereafter,insertion rod 5040 has been urged distally by thespring 5125 ofFIG. 181 , thereby engaginglocking pin 5155 with lockingpin hole 5404 andspacer engagement pin 5157 withspacer engagement hole 5406. The engagement of spacer engagement pin 157 withspacer 5405 keeps spacer 5405 from rotating about its axis, and thereby keeps thespacer 5405 in position relative to thetissue expander 5407 and to the main bodyimplant insertion instrument 5100. - II. Wing Insertion Instrument
- A wing insertion instrument of this invention is depicted in
FIG. 184-186 .FIG. 184 depicts an exterior, lateral view of awing insertion instrument 5500, having ahandle 5010, andinsertion shaft 5020, aninsertion tip 5030 and adriver knob 5050. As with the mainbody insertion instrument 5100 depicted inFIGS. 180 and 181 , on a lateral surface,insertion knob 5110, having raisedportion 5112 is provided to actuate a locking mechanism at the distal end of the instrument. -
FIG. 184 depicts a cross-sectional longitudinal view through thewing insertion instrument 5500 of this invention.Handle 5010 has aninsertion knob groove 5505 on a lateral surface, within whichinsertion knob 5110 is provided.Insertion knob 5110 andgroove 5505 are sized so thatinsertion knob 5110 can move in a proximal/distal path along thehandle 5010.Insertion knob 5110 has a raisedportion 5112 used for applying force to moveinsertion knob 5110 proximally and distally alonghandle 5010.Insertion knob 5110 is attached torod 5511, which is located withininterior space 5521 of thehandle 5010.Rod 5511 engagesinsertion rod 5541 byway ofset screw 5520 which is accessible throughhole 5515.Hole 5515 is desirably of sufficient size to permit complete removal ofset screw 5520 from the instrument, permittinginsertion knob 5110 to be removed fromhandle 5010 and the instrument to be cleaned and sterilized. -
Insertion shaft 5540 has a proximal end that fits within the distal portion of the bore ofhandle 5010.Set screw 5530 is inserted throughhole 5535, and engagesinsertion shaft 5540 withhandle 5010. It is desirable forhole 5535 to be of sufficient size forset screw 5530 to be completely removed, permitting cleaning and sterilization of the component parts ofinstrument 5500. -
Insertion rod 5541 extends through the full length of the bore ofinstrument 5500, and has a proximal portion sized to accommodatespring 5525. When installed inhandle 5010,insertion rod 5541 compressesspring 5525. The distal end ofspring 5525 is held in place byhandle end cap 5501, which, along withhandle 5010 can be made of, by way of example, Gray ULTEM™. Handleend cap 5501 is engaged withhandle 5010 by means of threads. Thus, for disassembly, handleend cap 5501 can be disengaged fromhandle 5010, andspring 5525 andinsertion rod 5541 can be removed from the proximal end ofhandle 5010. When assembled,rod 5511 andinsertion knob 5110 are urged byspring 5525 in a distal direction. The distal motion is stopped wheninsertion knob 5110 orrod 5511 reach the distal wall ofspace 5521.Spring 5525 is further compressed by manual movement ofinsertion knob 5110 in a proximal direction, acting viainsertion rod 5511. Becauseinsertion rod 5541 is engaged withrod 5511,insertion rod 5541 is drawn proximally by proximal movement ofinsertion knob 5110. When manual force oninsertion knob 5110 is relaxed, as for example, after alignment of a universal wing in relation toinsertion tip 5030,spring 5525 urgesinsertion rod 5541 andinsertion knob 5110 in a distal direction. Asinsertion rod 5541 is urged distally,driver 5555 is urged toward the distal end ofinsertion instrument 5500 as well. -
Driver knob 5502 is provided at the proximal end ofinstrument 5500.Driver knob 5502 can be made of, by way of example, Gray ULTEM™.Driver knob 5502 has a bore into which the proximal most extension ofinsertion rod 5541 is placed.Insertion rod 5541 is held withindriver knob 5502 by means ofset screw 5504 withinhole 5503. It can be desirable forhole 5503 to be sufficiently large so that setscrew 5504 can be completely removed fromdriver knob 5502 for cleaning and sterilization.Insertion rod 5541 desirably is free to rotate about its longitudinal axis, so that whendriver knob 5504 is rotated,driver 5555 is rotated. - In summary and referring to
FIGS. 181 and 185 , setscrews body insertion instrument 5100, and setscrews wing insertion instrument 5500 can be removed using a hex screw driver, having a hexagonal driver head made of, by way of example, 5455 stainless steel. Such removal can be used to disassemble theinstruments -
FIGS. 186 a-186 c depict details ofinsertion tip 5030 ofwing insertion instrument 5500 of this invention.FIG. 186 a is an end-view of the distal end ofinsertion tip 5030, showingdriver 5555, alignment pins 5560, and surfaces 5547 and 5565. An edge ofuniversal wing 5800 can abut surface 5547 to provide support during the insertion ofuniversal wing 5800. A surface ofuniversal wing 5800 can abut surface 5565 to provide additional support ofuniversal wing 5800. -
FIG. 186 b depicts a bottom view ofinsertion tip 5030 ofwing insertion instrument 5500.Insertion rod 5541 is depicted in a distal position, withininsertion shaft 5540.Driver 5555 is shown extending intospace 5567 ofinsertion tip 5030.FIG. 186 c depicts a bottom view of theinsertion tip 5030 as shown inFIG. 186 b with thedriver 5555 andinsertion rod 5541 in a proximal position, with the distal-most end ofdriver 5555 retracted from thespace 5567. In this position, mountingring 5816 ofFIG. 187 (below) of a universal wing can be received inspace 5567. -
FIGS. 187 a-187 c depict auniversal wing 5800 of the invention for use with thewing insertion instrument 5500 of the invention.FIG. 187 a is a lateral view ofuniversal wing 5800, havingcaudad portion 5801 andcephalad portion 5802. Alignment holes 5806 are adapted to receivealignment pins 5560 ofwing insertion instrument 5500. Although twoalignment holes 5806 are depicted, additional or fewer alignment holes can be provided. Betweencaudad portion 5801 andcephalad portion 5802, mountingring 5816 is provided having an oblong bore therethrough to receiveshaft 5814 ofbolt 5812.Bolt 5812 has a proximal end with arecess 5813 adapted to receivedriver 5555 ofinstrument 5500. The distal end ofbolt 5812 is threaded to engage withhole 5408 of atissue expander 5407 depicted inFIGS. 183 a-184 c. The oblong bore has partial threads that allow a bolt to be screwed through the bore with the smooth shaft of the bolt then trapped in the bore. -
FIG. 187 b is a side view ofuniversal wing 5800 withoutbolt 5812, depicting mountingring 5816 withoblong bore 5817 therethrough. Alignment holes 5806 are shown as dashed lines.FIG. 187 c depicts a similar view of universal with 5800 withbolt 5812 provided.Hex recess 5813, adapted to receivedriver 5555 ofinstrument 5500 is shown.Hole 5817 is oblong to provide a choice of positions ofbolt 5812 withinbore 5817. By providing a choice of bolt positions, the surgeon can install universal wing with a desired spacing betweenuniversal wing 5800 andmain body wing 5401. -
FIGS. 188 a-188 c depict the relationships betweenwing insertion instrument 5500 of this invention and theuniversal wing 5800 of the invention.FIG. 188 a depicts a lateral view of theinsertion tip 5030, withdriver 5555 inspace 5567 andalignment pin 5560.Insertion rod 5541 is shown withininsertion shaft 5540. Also depicted isuniversal wing 5800, havingbolt 5812 withrecess 5813, mountingring 5816,alignment hole 5806, andcaudad wing portion 5801. The axes ofdriver 5555 andalignment pin 5560, which in this embodiment cross each other and can be substantially perpendicular if desired, are shown in relation torecess 5813 andalignment hole 5806, respectively. -
FIG. 188 b depicts a lateral view ofinsertion tip 5030 engaged withuniversal wing 5800.Driver 5555 is received byrecess 5813 inbolt 5812 andalignment pin 5560 is received byalignment hole 5806.Bolt 5812 is received withinrecess 5567 ofinsertion tip 5030, and wheninsertion shaft 5541 is rotated,bolt 5812 can rotate. -
FIG. 188 c depicts a bottom view ofinsertion tip 5030 anduniversal wing 5800, engaged as inFIG. 188 b.Cephalad portion 5802 andcaudad portion 5801 of the universal wing are shown engaged byalignment pins 5560 received through alignment holes 5806.Edge 5807 ofwing 5800 is shown abutted againstsurface 5547 ofinsertion tip 5030. - III. Trial Implant Instruments
- Spinal implant surgery can be carried out by using specially designed instruments to determine the correct size of an implant to be used and to predistract the spinous process. The instruments incorporating trial implants comprise a handle, made of a convenient material, for example, Gray ULTEM™.
FIGS. 189 a-189 d depict four embodiments of trial implant instruments of the invention.FIG. 189 a-189 d depictinstruments handle 6006 andinsertion shaft 6007. The instruments differ in the size of the trial implant for each.Trial implant 6010 is the smallest,implant instruments - IV. Methods of Insertion of Spinal Implants
- To use the instruments of this invention to insert spinal implants of the invention, a patient is placed, desirably in a lateral decubitus position with maximum flexion of the lumbar spine. Lateral decubitus position permits easy orientation of the main body assembly during surgery. Generally, the implant can be inserted between the spinous processes from the bottom or right side of the spinous processes to the top or left side of the spinous processes. Such orientation permits easy visualization of the main body assembly when the universal wing is attached. The wings should be oriented properly, with
cephalad portions caudad portions - To insert a spinal implant in one affected vertebral area for a single level implant process, a midline incision about 1.5 inches long is made at the entry point, exposing the supraspinous ligament overlying the spinous processes at the symptomatic level. The fascia may be incised on either side of the spinous processes and supraspinous ligament. The paraspinous musculature can be elevated laterally from both sides of the midline. The supraspinous ligament is desirably preserved. The interspinous ligament may be separated to permit insertion of
main body assembly 5400. - To insert spinal implants in adjacent portions of the spine for a double level implant process, a midline incision about 3 inches long is made at the entry point, exposing the supraspinous ligament overlying the spinous processes at the appropriate segments. The fascia is incised if necessary on either side of the spinous processes and supraspinous ligament. The paraspinous musculature can be elevated laterally from both sides of the midline.
- The
first implant 5400 can be inserted at the inferior level, and thesecond implant 5400 of the same or different size, can be inserted at the superior, adjacent level after the first implant has been completely secured. If the supraspinous ligament is compromised during the procedure, it can be desirable to suture the excision in the ligament closed after insertion of the spinal implant. - Before installing the
spinal implant 5400, the intraspinous space is prepared using trial implants. Generally, the surgeon can first select the smallest trial implant, for example,trial implant 6000. Thetrial implant 6000 is urged between the spinous processes of the patient, and if little resistance is encountered, the surgeon can select a larger sized trial implant, such astrial implant 6001. If insufficient resistance is encountered, the surgeon can use progressively larger trial implants to distract the spinous process. When the correct trial implant is found, thespinal implant 5400 is then chosen for insertion. Additionally, the surgeon may choose to use a trial implant instrument that is larger than the implant to be used in order to further distract the spinous process to make the insertion of the implant easier. - To insert the main body assembly, a surgeon or assistant engages such assembly with main
body insertion instrument 5100 of this invention. The leading edge oftissue expander 5407 of the main body assembly is advanced through the interspinous ligament. If significant resistance is encountered during the insertion of the implant, the next smallest size main body assembly can be used. Once the correct sized implant has been selected, the main body implant is inserted as shown inFIGS. 190 a and 190 b. -
FIG. 190 a depicts a right lateral view of a portion of a spine of a patient. L4 and L5 refer to lumbar vertebrae 4 and 5, respectively. For purposes of illustration only, these lumbar segments are depicted. However, any spinal segments can be the sites of insertion of the implants by use of the instruments of this invention. L4-5D refers to the intravertebral disk. L4D and L5D refer to the dorsal spinous processes of L4 and L5, respectively. Mainbody insertion instrument 5100 havinginsertion tip 5030 attached tomain body assembly 5400 is shown in position.Cephalad portion 5402 andcaudad portion 5402 a of a main body wing are shown. It can be desirable to urgemain body assembly 5400 ventrally withinintraspinous space 6005. -
FIG. 190 b depicts a dorsal view of an insertedmain body assembly 5400.Spacer 5405 is shown between dorsal spinous processes L4D and L5D.Main body wing 5401 is shown near the right lateral surfaces of spinous processes L4D and L5D. -
FIG. 191 depicts a left lateral view of the L4-L5 area of a patient. Themain body assembly 5400 has been inserted, and thetissue expander 5407 is shown, urged ventrally inintraspinous space 6005. Mainbody wing portions hole 5408 intissue expander 5407 is shown, and axis (dashed lines) is shown to depict the insertion of threadedportion 5815 ofbolt 5812 ofuniversal wing 800.Insertion tip 5030 ofwing insertion instrument 5500 is shown, with a universal wing engaged 5800, as depicted inFIGS. 188 b and 188 c. The engaged wing is shown from the top view, in contrast to the view ofFIG. 188 c, which is from the bottom. While grasping mainbody insertion instrument 5100, the surgeon inserts the universal wing withwing insertion instrument 5500. When the universal wing is brought into the correct position relative to the main body assembly,bolt 5812 can be inserted intohole 5408 of thetissue expander 5407, and by rotation of thedriver knob 5050 ofFIG. 184 in a clockwise direction,driver 5555 can rotatebolt 5812 thereby engaging threads of the threaded end 815 with the threads ofhole 5408. Alternatively, if the threadedportions 5815 ofbolt 5812 andhole 5408 have left-handed threads, thendriver knob 5050 should be rotated in a counter-clockwise direction to engagebolt 5812 with threadedhole 5408. Before tighteningbolt 5812, it can be desirable to urgeuniversal wing 5800 medially or closer tomain body wing 5401 to provide a desired degree of support of spinous processes L1D and L2D. Once in the proper position,bolt 5812 can be tightened, and theinsertion instrument -
FIG. 192 depicts a dorsal view of the spine of a patient, depicting an installedmain body assembly 5400 withuniversal wing 5800 attached thereto.Universal wing portion 5802 is shown oriented in the cephalad direction, as is mainbody wing portion 5402.Caudad wing portions Wing element Universal wing 5800 is shown placed near the left lateral surfaces of the spinous process. Adjustment of the spacing betweenuniversal wing 5800 and the spinous process is accomplished by urging the wing medially before tighteningbolt 5812 inoblong mounting ring 5817. - V. Alternative Insertion Instrument Sets
-
FIGS. 193 through 196 depict alternative instrument sets of the invention. The aspects of these instrument sets, that are similar to the above described inventive instrument sets, are similarly numbered. Further, the description of the previously described instrument sets applies equally well to these alternative embodiments of the present invention. - In
FIG. 193 the mainbody insertion instrument 5100 is shown nested to thewing insertion instrument 5500. Both instruments together hold animplant 5400. With respect to the mainbody insertion instrument 5100 in this embodiment, thisinsertion instrument 5100 is essentially identical to that shown inFIG. 1 . Thewing insertion instrument 5500 has been modified to include an elongated concave recess 5580 (FIG. 194 ) which extends, in this preferred embodiment, for substantially the length of thehandle 5010. This elongatedconcave recess 5580 is shaped to conform to the outer surface of thehandle 5010 of the mainbody insertion instrument 5100. Accordingly thehandle 5010 of the mainbody insertion instrument 5100 can be nested in thisrecess 5580 so that the main body insertion instrument can be mated and nested to thewing insertion instrument 5500. (FIGS. 193, 194 ). This nesting affords the ability of the handles to align with each other so that the wing carried by thewing insertion instrument 5500 can be slid into place relative to and aligned with the main body carried by the mainbody insertion instrument 5100, as theinstrument 5500 is slid along the handle ofinstrument 5100. -
FIGS. 195 and 196 depict yet a further alternative embodiment of the instrument set including a mainbody insertion instrument 5100, and awing insertion instrument 5500. The mainbody insertion element 5100 in this embodiment includes an offsethandle 5010 which is depicted as offset from the shaft by about 45 degrees. It has been understood that greater and lesser offsets can be accomplished and be within the spirit and scope of the invention. The offsets servers two functions. The first function is that it gives the surgeon greater leverage in manipulating and positioning the main body of the implant through the ligaments associated with the spinous processes and eventually the spinous processes themselves. This additional leverage allows the physician to urge the main body of the implant into position. - Also it can be seen in
FIG. 195 , the mainbody insertion instrument 5100 includes aflange 5101. Thisflange 5101 is an additional enhancement to theinsertion tool 5100. It is then to be understood that the instrument set inFIGS. 195 and 196 can be fabricated without theflange 5101 and themating groove 5501 of thewing insertion instrument 5500 and still be within the spirit scope of the invention. As seen inFIG. 196 , themating groove 5501 of thewing insertion instrument 5050 is located in therecess 5580. - It is to be understood that without the
flange 5100 and themating groove 5501, the embodiment of theinsertion instrument 5100 ofFIG. 195 can be received in therecess 5580 of thewing insertion instrument 5500 ofFIG. 196 as thewing insertion instrument 5500 is moved relative to the mainbody insertion element 5100 in order to align the wing relative to the main body at the surgical site. - With the
flange 5101 and themating groove 5501 and with the embodiment of theinsertion element 5100 ofFIG. 195 positioned so that the main body is inserted through the spinous processes, thewing insertion instrument 5500 can be mated over the mainbody insertion instrument 5100 with the flange received in themating groove 5501. After this is accomplished, thewing insertion instrument 5500 can be slid relative to the mainbody insertion instrument 5100 in order to bring the wing into contact with and aligned with the main body. After this has occurred, the wing can be fastened to the main body. - It is to be understood that the
wing insertion instrument 5500 can also have an offset handle like the offset handle of mainbody insertion instrument 5100 ofFIG. 196 . - It is to be understood that other devices and methods for mating and aligning
insertion instrument 5100 with thewing insertion instrument 5500 can be envisioned and be within the spirit and scope of the invention. - From the above, it is evident that the present invention can be used to relieve pain caused by spinal stenosis in the form of, by way of example only, central canal stenosis or foraminal (lateral) stenosis. These implants have the ability to flatten the natural curvature of the spine and open the neural foramen and the spacing between adjacent vertebra to relieve problems associated with the above-mentioned lateral and central stenosis. Additionally, the invention can be used to relieve pain associated with facet arthropathy. The present invention is minimally invasive and can be used on an outpatient basis.
- Additional aspects, objects and advantages of the invention can be obtained through a review of the appendant claims and figures.
- It is to be understood that other embodiments can be fabricated and come within the spirit and scope of the claims.
- The foregoing description of preferred embodiments of the present invention has been provided for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Obviously, many modifications and variations will be apparent to the practitioner skilled in the art. The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, thereby enabling others skilled in the art to understand the invention for various embodiments and with various modifications that are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the following claims and their equivalence.
Claims (27)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/768,957 US20080039945A1 (en) | 1997-01-02 | 2007-06-27 | Spine distraction implant and method |
Applications Claiming Priority (26)
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US08/778,093 US5836948A (en) | 1997-01-02 | 1997-01-02 | Spine distraction implant and method |
US08/958,281 US5860977A (en) | 1997-01-02 | 1997-10-27 | Spine distraction implant and method |
US09/139,333 US5876404A (en) | 1997-01-02 | 1998-08-25 | Spine distraction implant and method |
US09/175,645 US6068630A (en) | 1997-01-02 | 1998-10-20 | Spine distraction implant |
US09/179,570 US6048342A (en) | 1997-01-02 | 1998-10-27 | Spine distraction implant |
US09/200,266 US6183471B1 (en) | 1997-01-02 | 1998-11-25 | Spine distraction implant and method |
US09/473,173 US6235030B1 (en) | 1997-01-02 | 1999-12-28 | Spine distraction implant |
US09/474,037 US6190387B1 (en) | 1997-01-02 | 1999-12-28 | Spine distraction implant |
US09/579,039 US6451019B1 (en) | 1998-10-20 | 2000-05-26 | Supplemental spine fixation device and method |
US21998500P | 2000-07-21 | 2000-07-21 | |
US22002200P | 2000-07-21 | 2000-07-21 | |
US09/799,470 US6902566B2 (en) | 1997-01-02 | 2001-03-05 | Spinal implants, insertion instruments, and methods of use |
US09/799,215 US7101375B2 (en) | 1997-01-02 | 2001-03-05 | Spine distraction implant |
US09/842,819 US7201751B2 (en) | 1997-01-02 | 2001-04-26 | Supplemental spine fixation device |
US30610101P | 2001-07-17 | 2001-07-17 | |
US30626301P | 2001-07-18 | 2001-07-18 | |
US32346701P | 2001-09-18 | 2001-09-18 | |
US09/981,859 US6712819B2 (en) | 1998-10-20 | 2001-10-18 | Mating insertion instruments for spinal implants and methods of use |
US10/014,118 US6695842B2 (en) | 1997-10-27 | 2001-10-26 | Interspinous process distraction system and method with positionable wing and method |
US10/037,236 US20020143331A1 (en) | 1998-10-20 | 2001-11-09 | Inter-spinous process implant and method with deformable spacer |
US10/747,534 US20040153071A1 (en) | 1998-10-27 | 2003-12-29 | Interspinous process distraction system and method with positionable wing and method |
US10/770,372 US7473268B2 (en) | 1998-10-20 | 2004-02-02 | Mating insertion instruments for spinal implants and methods of use |
US11/092,862 US7621939B2 (en) | 1997-01-02 | 2005-03-29 | Supplemental spine fixation device and method |
US11/806,529 US20080215058A1 (en) | 1997-01-02 | 2007-05-31 | Spine distraction implant and method |
US11/806,527 US20080039859A1 (en) | 1997-01-02 | 2007-05-31 | Spine distraction implant and method |
US11/768,957 US20080039945A1 (en) | 1997-01-02 | 2007-06-27 | Spine distraction implant and method |
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US11/806,527 Abandoned US20080039859A1 (en) | 1997-01-02 | 2007-05-31 | Spine distraction implant and method |
US11/768,958 Abandoned US20080065086A1 (en) | 1997-01-02 | 2007-06-27 | Spine distraction implant and method |
US11/768,956 Abandoned US20080288075A1 (en) | 1997-01-02 | 2007-06-27 | Spine distraction implant and method |
US11/768,957 Abandoned US20080039945A1 (en) | 1997-01-02 | 2007-06-27 | Spine distraction implant and method |
US11/768,960 Abandoned US20080039853A1 (en) | 1997-01-02 | 2007-06-27 | Spine distraction implant and method |
US11/768,962 Expired - Fee Related US8128663B2 (en) | 1997-01-02 | 2007-06-27 | Spine distraction implant |
US11/770,360 Abandoned US20080039946A1 (en) | 1997-01-02 | 2007-06-28 | Spine distraction implant and method |
US11/770,312 Expired - Fee Related US8828017B2 (en) | 1997-01-02 | 2007-06-28 | Spine distraction implant and method |
US11/770,198 Abandoned US20080167656A1 (en) | 1997-01-02 | 2007-06-28 | Spine distraction implant and method |
US11/770,201 Expired - Fee Related US8157840B2 (en) | 1997-01-02 | 2007-06-28 | Spine distraction implant and method |
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US11/806,527 Abandoned US20080039859A1 (en) | 1997-01-02 | 2007-05-31 | Spine distraction implant and method |
US11/768,958 Abandoned US20080065086A1 (en) | 1997-01-02 | 2007-06-27 | Spine distraction implant and method |
US11/768,956 Abandoned US20080288075A1 (en) | 1997-01-02 | 2007-06-27 | Spine distraction implant and method |
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US11/770,360 Abandoned US20080039946A1 (en) | 1997-01-02 | 2007-06-28 | Spine distraction implant and method |
US11/770,312 Expired - Fee Related US8828017B2 (en) | 1997-01-02 | 2007-06-28 | Spine distraction implant and method |
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US11/770,201 Expired - Fee Related US8157840B2 (en) | 1997-01-02 | 2007-06-28 | Spine distraction implant and method |
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Also Published As
Publication number | Publication date |
---|---|
US20080039853A1 (en) | 2008-02-14 |
US20080039858A1 (en) | 2008-02-14 |
US20080027553A1 (en) | 2008-01-31 |
US20080288075A1 (en) | 2008-11-20 |
US8828017B2 (en) | 2014-09-09 |
US20080167656A1 (en) | 2008-07-10 |
US20080039859A1 (en) | 2008-02-14 |
US8128663B2 (en) | 2012-03-06 |
US8157840B2 (en) | 2012-04-17 |
US20080039946A1 (en) | 2008-02-14 |
US20080065086A1 (en) | 2008-03-13 |
US20080215058A1 (en) | 2008-09-04 |
US20080033445A1 (en) | 2008-02-07 |
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