US20010031965A1 - Spine distraction implant and method - Google Patents
Spine distraction implant and method Download PDFInfo
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- US20010031965A1 US20010031965A1 US09/805,687 US80568701A US2001031965A1 US 20010031965 A1 US20010031965 A1 US 20010031965A1 US 80568701 A US80568701 A US 80568701A US 2001031965 A1 US2001031965 A1 US 2001031965A1
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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
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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
- A61B17/7062—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
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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
- A61B17/7062—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
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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
- A61B17/60—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
- A61B17/7053—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant with parts attached to bones or to each other by flexible wires, straps, sutures or cables
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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
- A61B17/7071—Implants for expanding or repairing the vertebral arch or wedged between laminae or pedicles; 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
- A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
- A61B17/025—Joint distractors
- A61B2017/0256—Joint distractors for the spine
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Abstract
Description
- This application is a continuation-in-part of the U.S. patent application entitled SPINE DISTRACTION IMPLANT AND METHOD having U.S. Ser. No. 08/778,093, and filed on Jan. 2, 1997.
- 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.
- 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 does FIG. 2.
- FIGS. 3a and 3 b depict side and end views of a first forked and of the embodiment of FIG. 1.
- FIGS. 4a and 4 b depict side sectioned and end views of an interbody piece of the implant of FIG. 1.
- FIGS. 5a and 5 b depict side and end views of a second forked end of the embodiment of FIG. 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 and13 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, 16a, and 17 depict yet another embodiment of the present invention.
- FIGS. 18, 19 and20 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 and25 depict another embodiment of the present invention.
- FIGS. 26, 27 and28 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 and33 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 and38 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 and43 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 and58 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.
- Embodiment of FIGS.1-5 a, 5 b
- 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 in FIGS. 3a, 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. 4a) of theinterbody piece 30. - The second forked end24 (FIGS. 5a, 5 b) includes a smooth
cylindrical shaft 36 which can fit into thesmooth bore 38 of theinterbody piece 30. - FIG. 1 shows the
implant 20 in a fully extended position, while FIG. 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 in FIG. 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 superspinous 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 hereinbelow 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. - Embodiment of FIGS. 6, 7,8, 9 and 10
- The embodiment of the invention shown in the above FIGS. 6, 7,8, 9 and 10 includes distraction or
spreader 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 in FIG. 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 in FIGS. 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 in FIG. 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. - Embodiment of FIGS. 11, 12 and13
- Another embodiment of the apparatus and method of the invention is shown in FIGS. 11, 12 and13. In this embodiment, the spreader or
distraction 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. - Embodiments of FIGS. 14, 15,16, 16 a, and 17
- In FIGS. 14 and 15, yet another embodiment of the invention is depicted. In this embodiment, the
implant 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 in FIG. 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. This
implant 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 of FIGS. 14 and 15. In particular, with respect to the embodiment ofimplant 130 of FIGS. 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. 16a depicts
second 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 of FIGS. 18, 19 and20
- The
implant 330 as shown in FIG. 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 - The
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.
- Embodiments of FIGS. 21 and 22
- The
implant 370 is comprised of first andsecond distraction cone spinous processes distraction cones fastening 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 in FIG. 22. - Embodiments of FIG. 23, 24 and25
- In FIGS. 23 and 24, another embodiment of the
implant 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 in FIG. 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 in FIG. 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, this
implant 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 of FIGS. 23 and 24 can also be used if desired. - Embodiment of FIGS. 26, 27 and28
- The embodiment shown in FIGS. 26, 27 and28 uses an implant similar to that depicted in FIGS. 8 and 9 with different insertion tools. As can be seen in FIG. 26, an L-shaped
distraction 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. - Embodiments of FIGS. 29, 30,31, 32 and 33
- As can be seen in FIGS. 29 and 30, the
implants - As can be seen in FIGS. 31, 32 and33, these implants can be placed in different positions with respect to the
spinous process 214. Preferably as shown in FIG. 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 in FIG. 31, the greatest force would be placed on the
implant 210 due to a combination of compression and extension of the spinal column. - Embodiment of FIGS. 34 and 35
- 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 in FIG. 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 in FIG. 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. - Embodiments of FIGS. 36, 37 and38
- The embodiments of FIGS. 36, 37 and38 which include
implants 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 implant232 positioned between upper and lower spinous processes. This implant is wedge-shaped or triangular shaped in cross-sectioned and includes bore
pluralities pins pins bore pluralities pins surface - Turning to FIG. 38, the
implant 234 has a triangular-shaped or wedge-shaped body similar to that shown in FIG. 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. - Embodiment of FIGS. 39 and 40
- 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 s pushed through thecannula 258 using aninsertion tool 262. Theimplant 260 includes a plurality of ribs or indentation 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.
- Embodiments of FIGS. 41, 42 and43
- The
precurved implant 270 in FIGS. 41 and 42, andprecurved implant 272 in FIG. 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 in FIG. 36. Thisimplant 272 in FIG. 47, however, is precurved and inserted over aguide wire 274 to a position between the spinous processes. As withimplant 230 in FIG. 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. - Embodiment of FIG. 44
- A further embodiment of the invention is shown in FIG. 44. This embodiment includes a combination insertion tool and
implant 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. - Embodiment of FIG. 45
- In FIG. 45, the
implant 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. - Embodiment of FIGS. 46 and 47
-
Implant 310 of FIGS. 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. - Embodiments of FIGS. 48, 49,50 and 51
- As can be seen in FIG. 48, the
implant 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 in FIG. 49, with longest dimension substantially perpendicular to the spinous processes, to the orientation shown in FIG. 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 - Embodiment of FIGS. 52, 53,54, 55 a and 55 b
- The embodiment of FIGS. 52 through 55b is comprised of a fluid-filled
dynamic 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 in FIG. 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 in FIG. 55a. 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. 55b). 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. - Embodiment of FIGS. 56, 57 and58
- The
implant 360 as shown in FIG. 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. - Embodiments of FIGS. 59 and 60
- 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. - Embodiment of FIG. 61
- The
implant 390 of FIG. 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 in FIG. 61. - Embodiment of FIGS. 62 and 63
-
Implant 410 of FIGS. 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. In FIG. 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 in FIG. 62 are removed and recesses428, 430 are substituted therefor. These recesses expand the area of the
saddles - Embodiment of FIGS. 64, 65 and66
- The embodiments of FIGS. 64, 65 and66 are similar in design and concept to the embodiment of FIGS. 62 and 63. In FIG. 64, the
implant 500 includes the first andsecond members Implant 500 includes first andsecond saddles second members saddles saddle leg second members - In the embodiment of FIG. 65, the
implant 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 of FIG. 65 with an
implant 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 - Embodiments of FIGS. 67, 68
- 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 central 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 second 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. - Embodiment of FIGS. 69, 70,71 and 71 a
- FIGS. 69, 70 and71 are perspective front, end, and side views of
implant 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 in FIG. 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 in FIGS. 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 in FIG. 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 and71 as well as the embodiment of FIGS. 67 and 68 are designed to preferably be positioned between the L4-L5 and the L5-S1 vertebral pairs. The embodiment of FIGS. 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 FIG. 69, 70, and71 as with the embodiment of FIGS. 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 of FIG. 71a 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 - Embodiment of FIGS. 72, 73
-
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 plunger 638 is positioned to extend from an end of thecentral body 632. As shown in FIG. 72, theplunger 638 is fully extended and as shown in FIG. 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 in FIG. 72. Thecentral body 632 is then positioned between adjacent spinous processes and theplunger 638 is allowed to move to the position of FIG. 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 in FIG. 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 in FIG. 73. - Embodiments of FIGS. 74, 75,76, 77, and 78
- Other embodiments of the invention are shown in FIGS. 74 through 78. FIGS. 74, 75 and76
disclose implant 700.Implant 700 is particularly suited for implantation between the L4-L5 and L5-S1 vertebra. As can be seen in FIG. 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 first 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 in FIG. 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 in FIGS. 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. The fourth arm TO 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 an
implant 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 309 and preferably about 20° whilesaddle 708 is sloped at about 30° and preferably more than 30°. - The
implant 760 as shown in FIG. 78 is similar toimplant 700 in FIG. 74 and is similarly numbered.Implant 760 includes third andfourth legs portions fourth arm - Embodiment of FIG. 79, 80,80 a, 81, 82, 83, 83 a, 84, 85 86 and 87
- 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 of FIGS. 79, 80 and 81. A perspective view of the distraction unit is shown in FIG. 84. The distracting unit as can be seen in FIG. 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 in FIG. 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 inventionFirst 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 theslot 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 and85, left side, plan and perspective views of the
second 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 FIG. 83 and86, the second wing or retaining
unit 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 in FIG. 83a 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 assembled
implant 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 in FIG. 86. Extending upwardly from thevertebrae second wings spinous processes - 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 TABLE 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. 80a shows an alternative embodiment of the
distracting unit 802 a. Thisdistracting unit 802 a is similar todistracting unit 802 in FIG. 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 with FIG. 86. Thebulbous end 808 a can extend past the threadedbore 820 by about 1 cm in a preferred embodiment. - Embodiment of FIGS. 88, 89,90 and 91
- Another embodiment of the invention is shown in FIGS. 88, 89,90 and 91. In this embodiment, the implant is identified by the
number 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 on FIG. 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 in FIG. 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 diferent 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, a
second 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. - Industrial Applicability
- 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.
Claims (40)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US09/805,687 US20010031965A1 (en) | 1997-01-02 | 2001-03-08 | Spine distraction implant and method |
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
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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 |
US09/200,266 US6183471B1 (en) | 1997-01-02 | 1998-11-25 | Spine distraction implant and method |
US09/306,140 US6156038A (en) | 1997-01-02 | 1999-05-06 | Spine distraction implant and method |
US09/805,687 US20010031965A1 (en) | 1997-01-02 | 2001-03-08 | Spine distraction implant and method |
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US09/306,140 Continuation US6156038A (en) | 1997-01-02 | 1999-05-06 | Spine distraction implant and method |
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US20010031965A1 true US20010031965A1 (en) | 2001-10-18 |
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US09/306,140 Expired - Lifetime US6156038A (en) | 1997-01-02 | 1999-05-06 | Spine distraction implant and method |
US09/361,512 Expired - Lifetime US6152926A (en) | 1997-01-02 | 1999-07-27 | Spine distraction implant and method |
US09/805,687 Abandoned US20010031965A1 (en) | 1997-01-02 | 2001-03-08 | Spine distraction implant and method |
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US09/306,140 Expired - Lifetime US6156038A (en) | 1997-01-02 | 1999-05-06 | Spine distraction implant and method |
US09/361,512 Expired - Lifetime US6152926A (en) | 1997-01-02 | 1999-07-27 | Spine distraction implant and method |
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