CA2244197A1 - Articulating joint repair - Google Patents
Articulating joint repair Download PDFInfo
- Publication number
- CA2244197A1 CA2244197A1 CA002244197A CA2244197A CA2244197A1 CA 2244197 A1 CA2244197 A1 CA 2244197A1 CA 002244197 A CA002244197 A CA 002244197A CA 2244197 A CA2244197 A CA 2244197A CA 2244197 A1 CA2244197 A1 CA 2244197A1
- Authority
- CA
- Canada
- Prior art keywords
- balloon
- joint
- biomaterial
- order
- bio
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
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- 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
- A61B17/7097—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants
- A61B17/7098—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants wherein the implant is permeable or has openings, e.g. fenestrated screw
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- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30581—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid
- A61F2002/30583—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid filled with hardenable fluid, e.g. curable in-situ
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/3094—Designing or manufacturing processes
- A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
- A61F2002/30957—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using a positive or a negative model, e.g. moulds
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/42—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
- A61F2/4225—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for feet, e.g. toes
- A61F2002/4233—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for feet, e.g. toes for metatarso-phalangeal joints, i.e. MTP joints
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
- A61F2002/444—Intervertebral or spinal discs, e.g. resilient for replacing the nucleus pulposus
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2002/4635—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor using minimally invasive surgery
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- A—HUMAN NECESSITIES
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- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0085—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof hardenable in situ, e.g. epoxy resins
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- A—HUMAN NECESSITIES
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- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0021—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in coefficient of friction
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- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/38—Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
- Y10S623/92—Method or apparatus for preparing or treating prosthetic
Abstract
A method and related materials and apparatus for using minimally invasive means to repair (e.g., reconstruct) tissue such as fibrocartilage, and particularly fibrocartilage associated with diarthroidal and amphiarthroidal joints. The method involves the use of minimally invasive means to access and prepare damaged or diseased fribrocartilage within the body, and to then deliver a curable biomaterial, such as a curable polyurethane system, to the prepared site, and to cure the biomaterial in situ in order to repair the fibrocartilage. Applications include repair (e.g., reconstruction or replacement) of the intervertebral disc of the spine. An apparatus is provided in the form of an uninflated balloon that can be inserted into the disc space and there inflated with biomaterial in order to distract the space and provide a permanent replacement disc.
Description
.
W O 97/26847 PCTrUS97100457 ARTICULATING JOINl~ REPAIR
TECHNICAL FIET n The present invention relates to mtothorls~ a~ es, m~t~P-ri~l~ and IIIS for the repair of movable and mixed arti~-ul~ting joints in the body.
CROSS-REFERENC3~i TO RELATED APPLICATIONS
This applir~tinn is a contin~l~tinn-in-part of U.S. Applic~ti--n~ having Serial No. 08J590,293, filed January 23, 1996, which is a con~ ;Qn-in-part of Serial No. 08/239,248, filed May 6, 1994 for JOINT RESURFACING ~Y~
BACKGROUND OF THE INVENTION
The joints of the body can be clq~ifieA as be~ween those that provide immovable artic~ tion~ (syll~lluidal)~ mixed artir~ l~tions (an~ i~Lllloidal), and movable articnl~tiQn~ (diarthroidal). The ability of ;~ hi~ uidal and <li&Lllll~idal ~oints to provide ~rî~;Live and pain-free artic~ ti~ n, and/or to serve their weight-bearing function, is gener~lly dependent on the presence of intact,healthy r~l,r~c~lilage and/or hyalin cartilage within the joint.
In an ~ oidal joint such as the lumbar joint of the back, the are se~dled by an intervertebral disc formed of rll"~Lilage. More palticularly, the intervertebral disc is co..,l.. ;~PA of an outer ~nnnlll~ fibrosis formed of fibrocartilage. The ~nnllll-~, in turn, surrounds and contains a more fluid m~tPri~1 known as the n~lcle~ls pulposus. By virtue of its fluidity, the n~c leus allows ~or both movement and weight-bearing energy transfer. In healthy, generally you- g~ individuals, the ~nntll~ls is intàct and the nllrleNs pulposusremains quite fluid.
As people age, however, the ~nnlllll~ tends to thic~-n, desic~r~tto, and become more rigid. The nucleus pulposus, in turn, becomes more viscous and W 097126847 PCTrUS97/00457 less fluid and so...~t;.~Ps even deh~dldtes and contracts. The zinnllllls also becomes susc~L~Lible to Ll ~;L~ or fic~nring. These fractures tend to occur all around ~he ch-;u",re~ ce of the zlnn~ 5, and can extend from both the outside ofthe z7nm~ s inward, and from the interior ouLw ~. Ocr;icionz11y, a fissure from ~e outside will meet a fissure from the inside and will result in a co".~leLe rent through the ttnn~ c fibrosis. In a situation like this, the nUclells pulposus may extrude out through the inter~.Lebldl disc. The extruded m itPrizll, in turn, can impinge on the spinal cord or on the spinal nerve rootlets as they exit through the in~lveLLe~l~l foramen, res~-ltin~ in the sy~ o-lls zic~ocizttP~ with the classic"ruptured disc".
The current surgical approach to treating a deg~nto.r~SP~l intervertebral disc g~nPrzilly involves the process of micr~ cectomy~ in which the site is z~ccPc~P~l and the protruded mzit~rizll is removed. This often produces .ci~nificzlnt relief, provided it is a fairly minor, or mild, lC!rZtli7f'~l disc ~ u~;on. In such a ~ U1~ a small in~i~ion iS made, through which the disc is vicuzlli7Pfl~ The areaof protruded mz tt-rizil iS removed, thus decoll,~l~s~.ilg the nerve rootlet that has been impinged on by the extruded mzit~.riz~l.
In more severe situations, however, the ~nn~ c fibrosis becoll,es ~lcge--e.~ fl to the point where very little disc space remz inc, and much of the nll~leus plllrosus is ei~er con~,~l~ted or has been extruded. l?P~ior~zil os~opl.yles can also develop around these areas. The combinzlti~ n of the extruded mzlt.ortzll and the osteophytes, together with the narrowing of the intervertebral disc space produces a mztrk~Yl n all.,willg of the intervertebral foramen and impin~em~n~ on the spinal nerve rootlet as it exits the canal. This is the cl ~cci~l situation that results in radicular pain with axial loading.
When this occurs it becomes nPcçc~t.y to reestablish the intervertebral space. The current approach to this more severe situation is a lumbar l~tminP~ctomy (to decol,-p~ess the nerve rootlet) with fusion of the disc space. The bony lamina is removed to decompl~ the intervertebral f~ ;n~ and the bone graft is taken from the anterior iliac crest and attached from one v~leblde body to W O 97/26847 PCTnJS97100457 the next. The rçs--ltin~ fusion will ..~int~in stability at that point and also help in the s~aldtion of the vertebrae.
Recent advances in this technology have been developed by such co.. ll~nies as Spine-Tech, MinnP~I olis, MN, which involves the use of a ~ i,l ll alloy S cylinder. The cylinder is screwed into the intervertebral space to assure the stability of the spacing until a fully bony ankylosis can be obtained. The cylinders are packed with bone and are fenestrated so that the packed bone can grow out into the ~ rPnt ve.L~ de and solidify the fusion. To date, however, clinical results on the long-term follow up of these p~tiPnt~ are not available and the efficacy is still in doubt with many spine ~ul~ eons.
It would Ll,er~lc be particularly useful to be able to repair such injuries in a Ill~mef that avoids invasive surgical procedures and the problems ~oci~tr~d SUMMARY OF THE INVENIION
The present invention provides a method and related m~tr-,ri~1~ and ?CLld~us for using minim~11y invasive means to repair ~e.g., reconstruct) tissuesuch as fibluca Lilage~ and particularly fibloc~ilage ~ori~tPJl with di~ uidal and ~mphi~rthroidal joints. The method involves the use of minim~lty invasive means to access and ~r~p~t; r1~m~r~1 or ~ ed fibrocartilage within the body, and to then deliver a curable bic.",i~t~ 1 to the pr~ d site, and to cure the biom~tPri~1 in s~n~ in order to repair the fibruca lilage and replace the function of the rl~m~E~Pd cartilage. The bio",~r~ 1 provides an optimal cc.".~ l;nn of such l..u~l~ies as deliverability and curability, as well as bioco~ atability, biostability, 2~ and such physical pelrui.. ~nre char~cteri~tirs as strength, el~ticity~ and lubricity.
In one embortimr-nt, the method comprises the steps of:
a~ using minim~lly invasive means to remove rl~m~gr-cl or ~
fibrocartilage from a di~hLl,loidal or anl~hia ll-lùidal joint, and to create a mold capable of co~ ;n~ curable biom~teri~1 in a desired position within the joint, W 097/26847 PCTr~S97/00457 b) providing one or more curable biom~tPri~l.c to the structure previously occ~piPA by the removed fiblu~hLilage, and c) curing the biom~tPri~l.e in order to provide a repl~rPmPnt for the fibl~ Lilage.
S The mold created within the joint is preferably of s-lffi~.irnt shape and imPneion~ to allow the res~-l*n~ cured bio...; ~ 1 to replace or mimic the structure and function of the removed rlbl~lilage. The mold can be formed of synthetic andJor natural m~t~ri~l~, including those that are provided eYn~.nously and those provided by the rP.m~ining natural tissues. The mold c~n either be l~ lo~ed from the site, upon curing of the biom~tPri~l, or is sllfficie-ntly bioco~ hle to allow it to remain in position.
The mold can take the form of either a positive and/or negative mold. For in~t~nce, the mold can take the form of an outer shell, capable of lel .il,;,.~
biom~t.o i~l within its interior cavity. Optionally, the mold can also take any other suitable form, incl~Ain~ to serve as an interior core (e.g., to create a doughnut shaped biom~tpr~ or as an anchor point for the stable ~tt~chm~-nt and loc~li7~tion of delivered bi~
In a particularly ~ler~.~ed emboAimPnt, the m.othod is used to repair an amphiarthroidal joint such as an intervertebral disc and compricps the steps of:a) using mic~ L~ical techniques to ~lr~,r-n a ~licce~;L~ y while preserving an outer annular shell, b) providing one or more curable bio...~t~ to the interior of the annular shell, and c) curing the bio.,l~ in order to provide a re~ r~mPnt disc.
In such a ~lefc.l~ emboAim~nt the distraction of the disc space is accomplished by means of a suitable Aictr~rtion means, such as an inflatable, yet rigid, balloon or bladder. The balloon can be delivered in defl~t~d form to the interior of ~e ~nn~ and there infl~tP~d in order to distract the disc space and provide a region for the delivery of bio"~ 1 The balloon is pl~;re.~bly of W O 97/26847 PCT~US97/00457 _ 5 _ snfficiPnt strength and suitable rlimPn~ions to distract the space to a desired extent and for a period long enough for the bio...~ 1 to be delivered and cured.
In a pç~r~.led embotlimPnt the invention provides a fli~tr~tion device cqmpri~ing an insertable, defl~tP(l balloon formed of a self-venting, biocc"l~a~ible material capable of re~ i"g polymer and ~ tr~tin~ a joint space at up to about 10 ~tmo~rhPre pl~S~
In other ~pP~ct~, the invention provides biom~tPri~1~, inflllfling polymer systems, useful for ~lÇo~ ing such a mPthod, as well as mPthorls of pf~ g and using such bio..~ . In yet further aspects, the invention provides a diarthroidal or ~mphi~ . lhl~idal joint having interposed therein a biom~tPri~l that has been cured in situ.
DETAILED DESCRIPIION
Appli~nt~ have discovered a means for proc~lcinf~ spinal Cp~ t;on to achieve pain relief, which involves the step of interposing cured biom~tP-ri~l in the intervertebral disc space.
Definitions As used herein the following words and terms shall have the mP~nin~
ascribed below:
"repair" will refer to the use of a biol--~r-;~l to replace or provide some or all of the structure or function of natural tissue in vivo, for in~t~n~e, to repair (e.g., reconstruct or replace) cartilage, such as fibrocartilage, present in a di~~ idal or amphiarthroidal joint. Repair can take any suitable form, e.g., from p~t~hing the tissue to replacing it in its entirety, preferably in a manner that reconstructs its native ~limen~i~)ns;
"bio..,~le,;~l" will refer to a m~tPri~l that is capable of being introduced to the site of a joint by minim~lly invasive means, and be cured to provide desiredphysic~-chPmic~1 plo~.~ies in vivo;
"cur~" and inflP~tions thereof, will refer to any chPmi~ ~l-physical tran~rol.lla~ion that allows a biom~tpri~l to progress from a form (e.g., flowable W O 97/26847 PCT~US97/00457 form~ that aliows it to be delivered by minim~lly invasive means, to a more permanent form for final use fn vivo. When used with regard to the method of theinvention, for inctAnce, "curable" c_n refer to uncured bic,...~ 1, having the potential to be cured in vivo (as by the application of a s~ hl~- energy source), as S well as to a biomAt~-ri~l that is in the process of curing, as with a bi~ t- ;Al formed at the time of delivery by the cc,ncurrent mixing of a plurality of biomaterial co,ll~onents;
"minim~11y invasive means" refers to surgical means, such as mic~ ul~,ical or endoscopic or ~LIlrosco~ic surgical means, that can be accomrlich~d with minim~l disruption of the pertinent musculature, for in.ct~nr,e, without the need for open access to the tissue injury site or Llll~,u~1~ minim~l inricionc (e.g., in-~icionc of less than about 4 cm and ~fef~.ably less than about 2 cm). Such surgical means are typically accomplished by the use of vic~-~li7~ti~ n such as rlbc~ lic or micl~sco~ic vi.c--~li7~tion, and provide a post-operative recovery time that is s~ib~ lly less than the recovery time that acco,.. ~ s the cc,l.~s~llding open surgical approach;
''PnrloscQFir-l~hLlllosco~ic surgical insLlul,lent" refers to the controllers and associaled h~lw~G and software ne~x.$.~.y for ~.rOll~ g conve~-l;o c~sc~ic or ~LII~O5c~C surgery; and "delivery e~nn~ " shall mean a cannula capable of being operated in a rninim~lly invasive fashion, e.g., under alLhl~scopic vi~ li7~tion~ togeth~r with l~ comlecli~re tubing and co~ i for the operable and fluid ~tt~hment of the r-~nmll~ to a source of bio...~ 1 for the storage, delivery, and recovery of bio."~ of the present invention.
l~ethod In a plt;rell~d embodiment, the present invention provides a method and related m~teri~l~ and a~aldlus for ~ -g di~Lllruidal and a ll~h;~~ idal joints by minim~lly invasive means. The method involves the use of minim~lly invasive means to ~)lG~al'G the site of injury, deliver a curable biom~t~ l to the joint site, and to cure the bi~ l in situ in order to repair fibrocartilage.
W O 97/26847 PCTrUS97/00457 The method of the invention can be used to repair a nul"ber of tissues, in~ ling a variety of joints, and is particularly useful for diarthroidal and llroidal joints. Fx~mr1Ps of suitable ~mpl-iA. Ihroidal joints include the synphysoidal joints, such as the joints between bodies of the vc. lel)r~e. Such joints provide s~ res connP~t~l by fil)roc~lilage, and have limited motion.
Other PY~mplPs include syntle~mo~ joints, having s~-rf~-es united by an interosseous lig~mpnt~ as in the inferior tibio-fibular joint.
F.Y~mrles of suitable di~ ,idal joints include the ginglyll~us (a hinge joint, as in the interphalangeal joints and the joint between the humerus and the ulna); throchoides (a pivot ioint, as in superior radio-ulnar artic~ tion and atlanto-a~ial joint); condyloid (ovoid head with elliptical cavity, as in the wrist joint);
reciprocal reception (saddle joint formed of convex and concave snrf~ces, as in the carpo-met~ ~rpal joint of the thumb); en~ rusis (ball and socket joint, as in the hip and shoulder joints) and arthrodia (gliding joint, as in the carpal and tarsal afic~ t-on~)~
In a particularly ~ erGlrGd embo~lim~nt the method is used to repair an Al..pl i~ oidal joint such as an intervertebral disc and compri~es the steps of:a) using miclo~u~gical techniques to ~Glrol." a di~e~lollly while preserving an outer annular shell, b) providing a curable biom~teri~l to the annular shell, and c) curing the polymer in order to provide a rep~ m~nt disc.
As can be seen, the annular shell can itself serve as a suitable mold for the deliv~l~ and curing of biom~t~ri~l Optionally, the interior surface of the annular shell can be treated or covered with a suitable m~t~ri~l in order to enh~nce itsi~ y and use as a mold. Preferably, one or more inflatable devices, such as the balloons descrihe~l herein, can be used to provide molds for the delivery ofbiom~t~ . More preferably, the same inflatable devices used to distract the joint s~ace can further function as molds for the delivery and curing of bio, . .~ . ;Al W O 97/26847 PCTrUS97/00457 Diseeclollly A Ai~ ol~y ~l.e., removal of some or all of the nucl~us plllrosis, leaving an outer annular shell~ is ~clrcrll.ed, with optional ~ tr~-finn and repair of the ~nn~lln~, in order to remove the destroyed nucleus m~tPri~l while providing an S intact annular shell. By "intact", it is meant that the ~nnullls, either alone or with optional s.,L~lling means, is of s--ffi~P!nt strength and il~leglity to retain a1 in a desired position and in the course of its use (delivery and curing).
The mielo~ulgcly for the polymeric intervertebral disc repl~mPnt can be carried out using techniques well within the skill of those in the art, given the present tP~hing. The ~nn-~ $ can be viewed, for in~t~nce, remote vi~ li7~tion techniques such as fiberoptic vi~ li7~tinn. The inLcgli~y of the annular shell is ~e~se~l, and optionally, the shell itself is lc~aired, e.g., by the application of a biocolllpaLible p~t~hing m~teri~l, such as a fibrin glue.
The destroyed disc m~tPri~l is çle~necl out and the ~nn~ is ~ ntoA. out to the edges of the ~nnnll-~ The annular shell, in~ ltling any l~paif~d portions are preferably of sllffic;~nt strength and Aim~ncions to allow the bio..~ l to be delivered and cured. The le ..~ini~g, r~ d ~nnlllll~ then serves as an outer barrier for the curable bio.. ~t~ ;~1, thereby serving to provide ~ n~
and location for the cured bio.,.~
Once the nl-c1ell~ pulposis has been removed and the lc~ ini~ nnnllls ;~dil~d, the annular shell can itself be used as an envelope to contain the delivered biom~t~ri~l. Optionally, and pl~r~ldbly, means are provided to containthe bio ~ t~ l within the desired space, e.g., by forming an ~AAition~l envelopewithin the ~nmllllc.
As used herein the word "~ tr~ction", and inflections thereof, will refer to the sep~.i.ti~n of joint s-lrf~çs to a desired extent, without rupture of their binding m~.nt~ and without displ~em~nt Distraction can be accomplished by any suita~le means. Such means include m~h~ni~l means and hydrostatic means, e.g., by ~ d injection of the biom~t~ri~l itself. By the use of distraction, the disc space can be sl~Mcipntly re-established to achieve any desired final W O 97126847 PCTrUS97/00457 _ g _ dimPn~ions and position. Optionally, and preferably, the means used to accomplish distraction also serve the pul~ose of forming one or more barriers ~e.g., envelopes) for the uncured bio...~f~ l itself.
The disc space can be ~ tr~tf~ prior to and/or during either the tli~x~to~y itself and/or delivery of bif~ f-;~l A co~trit~-tf~1 disc space is ~enPr~1ly on the order of 3 to 4 mm in the fli~t~nfx between v~ plates.
Suitable ~i~tr~ctiorl means are capable of providing on the order of about 3 atmospheres to about 4 atmospheres, (or on the order of ahlout 40 psi to about 60 psi) in order to distract that space to on the order of 8 to 12 mm between the vertebral plates.
Di~tr~rtif~n can be accompli~hf~ by any suitable means, inr,lutlin~ by mPrh~nir~l andfor hyd~ ic means. MPrh~nir~l means can incl~<le, for in~t~nce, ~tt~r.hing hooks or jacks to the bony endplates and using those hooks or jacks to separate the bones. Optionally, the ~ul~;eon can employ eYtern~l t~çtio~, however, with the patient on their side, eYtPrn~l traction will likely not be ~L~r~
Optionally, and ~l~reldbly, the space is ~ d by the use of one or more s-lit~hle insertable devices, e.g., in the form of inll~L~ble balloons. When infl~tP~l, such balloons provide rigid walls (e.g., fiber :iup~l~d) that are sllffif~iP.ntly strong to distract the space. An inflatable device provides s~-ffi~ient ~tlen~ and ~limPn~ion.~ can be prepared using convPntion~l m~tPri~l~ In use, theninfl~tPA balloon can be delivered to the center of the annular shell, and there;~n~l~ed to e~cpand the annular shell and in turn, distract the space.
The infl~t~hle device can be delivered to the disc space by any suitable means, e.g., in defl~tP~l form retained within or upon the end of a rigid or semi-rigid rod. Once positioned within the disc, generally centrally within the annular shell, a suitable gas ~e.g., nitrogen or carbon dioxide) can be delivered through the rod in order to inflate the balloon in situ, in a ~ n~ ly radial direction.
The fact that the balloon is properly placed can be confirmP~ by the use of W O 97/26847 PCTnUS97/00457 ancillary means, such as cine using a C arm, or by self-eff~ting means embodied within the balloon itself or its delivery a~ C
Suitable materials for p~ ing balloons of the present invention are those S that are plcse.. tly used for such ~ul~30ses as balloon angioplasty. Suitable m~tPri~lc provide an optimal coll.bination of such ~r~ Lies as compliance, biostability and biocoll,patability, and ".~h~llir~l char~ct~-ri~tics such as el~cti~ity and strength. Balloons can be provided in any suitable form, in~ ing those having a plurality of layers and those having a plurality of co"~ l-ents when exr~nde~l A useful balloon a~al~llus will include the balloon itself, togeLl-el with a delivery c~thet~r (optionally having a plurality of lumen eYtP.n~ing longitu~lin~lly LL. r~willl), and fluid or gas ~res.,ulc; means.
FY;~...ples of suita~le m~teri~l~ (e.g., resins) for making baUoons in~ de, but are not limited to, polyolefin copolymers, polyethylene, polycarbonate, and polyethylene terephth~l~t~ Such polymeric m~tt~ri~l~ can be used in either ullsu~ d form, or in ~u~olLed form, e.g., by the il~ ion of dacron or o~her fi~ers.
Balloons can also take several forms, d~n~linp on the manner in which the bio, ~le. i~l is to be delivered and cured. A single, thin walled balloon can be used, for in~t~nre, to contact and form a barrier along the interior surface of the annular m~t~.ri~l. Once positil~n~1, one or more curable bio...~t~ ;~ls can be delivered and cured within the balloon t~ serve as a repl~ ent for ~e removed m~t~ l In such an embo-limPnt the balloon is pr~r~l~bly of a type that will allow it to remain in position, without undue detrim~nt~l effect, belweell the annular m~tPri~l and the cured bio",~
Optionally, a balloon can be provided that fills less ~an the entire volume of the annular shell. In such an embo limlo-nt the balloon can be, for in.~t~nr,e, in the sha~?e of a cylinder. Such a balloon can be provided such that its ends can be po~ition~rl to contact the opposing vertebral bodies, and its walls will providesllffiçient strength to cause distraction of the space upon infl~ti~n, WO 97~6847 PCTrUS97100457 The~rlel, a first bio~ r,;~l is delivered to perimf~tpr of the annular space, i.e., the space be~ween the annular m~tPri~l and the balloon, and there cured. The biom~tpri~1 is delivered using suitable means, and under conflition~
suitable to ensure that it will not extrude through tears in the ~nm~
Optionally, the balloon can be p~r7~ 11y defl~tPcl as ~ 1ition~1 biCj."~tf ~ ;~1 iS
inserted into the space.
With the outer bio~ P ;~1 cured in place, the balloon can be removed and an additional biom~tP-ri~l, of either the same or a dirrt;n,lll type, can be deli~ d and cured in whatever re",~ g space was previously occupied by the balloon. A
second r~nmll~ can be used to deliver a second bio.~ l, pref~ldl)ly one that cures to provide a more fl~Yih1e region that more closely a~ i",~t- s the physical Gh~r~t~ri~ff--s of the origin~l nlleleus This method provides the option to lcconslluct the disc in a manner that more closely a~r~x;l~tes the overall physical r~ tr ;~tics and relationship of the crigin~l ~nn~ s and nU~ m:
A two step approach, as described above, is ~l~r~lled for a number of reasons. It provides the means for distracting the joint, while at the same time~- itit~ting the ~ aldtion of a final reconstructRd ~nnu~ having two or more regions. The dirreLel-t regions, i.e., a rigid outer shell in combination with a more liquid interior, can provide a function that mimics that of the native disc. In 2() addition to a two step approach, however, an impl~nt having a plurality of regions, ean be provided by other means as well. For inst~nr~, such an imp1~nt can be provided by the delivery of a s;ngle bio ~t~ 1 that is cured to a greater or ~liri'r~ g extent in its outermost, as co,.l~al~d to innermost, regions. An implant having a plurality of regions, or even a co~ llll of plop~Lies, is particularly 2~ ~rC~ Gd.
In an optional and pl~Çell~d emborlim~nt as descrihe~l above, a balloon can be inserted in nninllzlt~l form by means of a delivery f~thPter, e.g., in the form of a shaft, into the disc space. The balloon can be properly position~l in the discspace, e.g., within the annular shell following ~ ceclo-~~y~ and infl~t~l upon 3Q filling with biom~t~ri~1 in order to expand the balloon and thereby distract the space. In such an embodiment, the balloon can be inserted into the space, e.g., in 11ninfl~te~ or partially infl~t~l form, and filled in whole or in part with bio...At~ ;A1 under suffic~ nt con~1itiorl~, in~]u-ling ~7~ U1C~ to distract the space.
Con~ lenlly, the biom~t~-ri~l can be fully cured in the course of filling the balloon, in order to be retained ~ 1y in posi~on within the balloon and the ~ictr~cted space.
A ~ r.~led balloon configuration incl~des an 1minfl~ted balloon ~tt~-~hecl to a shaft, both of which are optffonally provided in a iniffal form covered by a removable sleeve portion, the assembled device being useful as an applicator to deliver the b~lloon in llninfl~t~d form to the disc space. A suitable balloon ~tt~-hmf~nt site is provided in the forrn of an inte~r~1 balloon stem portion, which can be retained in sealed but severable contact with the distal end of the shaftA suitable sleeve portion is provided in the form of co~ 1, telescoping sleeve having both a nall.,wed region ~limen~iQned to cover the shaft itself, and an e~r~nded region capable of Lcl~ining the balloon in a rolled or folded configuration in the course of delivering the baUoon to the site. Th~l~,l, as the sleeve is removed, the eYp~nded pocket is pulled back to release the balloon in situ. The sleeve can be fat~ricated from suitable m~tori~l~ and using techniqueswithin the skill of those in the art, given the present des~ Lion. Optionally, any portion, region or surface of the sleeve, shaft or balloon can be treated with friction rel~1cin~ co~t;~gs or other m~t~.ri~l.c to i,npf~,ve or otherwise alter the lubricity or other physical or ch~mi~ Lies.
A balloon of the present invention can be inflatably ~ f hed (e.g., provided in an releasable and u~ .n~1~A configuration) within or upon the end of a delivery shaft, in order to be inserted into the disc space. Pre~erably, the shaft and balloon are of sl-ffi~ nt flimen~inns and L)-o~Les to permit the balloon to be inserted using minim~lly invasive means, inc1ullin~ fiberoptic vi~n~1i7~tion-The shaft is preferably provided in the form of an elc)ng~tpcl tube having a distal end capable of being inserted to the disc space by minim~lly invasive means, and a pl'UAilllal end providing an ~ts~chmpnt site for a source of bioll.alefial. The CA 02244l97 l998-07-22 WO 97/26847 PCTrUS97/00457 shaft is s--ffi~i~ntly stiff and flexible to permit it to be inserted into a tissue access site of on the order of 4 cm or less, and preferably on the order of 2 cm or less, and moved through the body to access the disc site, while also having sl~fflc~ nt ~limfn~ions and surface properties to permit the flow of a desired bio;"~ l intoS the ~tt~hP~l balloon.
Once in place within the disc space, the balloon can be finally position~d within the space and filled with biom~ter~ flowing through the shaft, and under suM~ nt plC;S:~UlG to distract the space. In a ~rGrc;lred emb~imPnt, the balloon is "self-venting", in that whatever volume of gas may be present within the balloonlQ and shaft at the time of insertion can be ~ pl~cecl by the bio.. ~lf -;~l and vented through the balloon walls, e.g., to the ~ull~u~lding tissue. Optionally, or additionally, the shaft and/or balloon can be ev~n~tP~cl by the applic~tion of suction or vacuum to the shaft.
r~f~l~bly, some or all of the gas (e.g., air) present within the shaft and/or balloon is vented l~Lrougll the balloon m~te~i~l by virtue, and in the course, of the delivery of bio~ f ~i~1. As the bio.~ P- ;~1 fills the balloon, and ~ rl~$ the gas, the biomaterial also serves to inflate the balloon to a desired extent, and in asuitable position to distract the disc space. Once the disc space has been s -ffieient~y ~ t~t~te~1, the biomaterial can be cured, or ~l.lliUed to fully cure, in 2Q si~u in order to retain the balloon and biom~tPri~l pe",-~ .n~ly in place.
A ~lc;Ç~l~d fli~tr~-~tion device of this type compri~es an insertable, .J~ .n~l~ balloon formed of a self-venting, bioccslllpaLible m~tPri~l capable ofe~ a biom~teri~l in the course of joint distraction. Such a device, for in~nce, is capable of distracting a joint space by providing up to about 5 atmospheres or more ~ t~ction pSeS~Ule~ and preferably up to about 10 mos~heres or more. Preferably, the balloon itself is capable of wi~ ing y greater pl~s:;ure than that required to distract the space, e.g., up to about 10 atmo~ eles and preferably up to about 15 atmospheres or more.
Ln a particularly pl~cf~l~ed embodiment, the balloon is fabricated from natur~l or synthetic m~t~ , induding but not limited to, polymeric m~tPri~
W O 97126847 PCT~US97/00457 suc~ as films or membranes, and woven or nonwoven fabrics or m~-ch~s~ having ies s~lffiçi~nt to permit gasses to be vented th~ough the m~t.o.ri~1 in situ in the course of delivering the biom~t~.ri~1 Ihe balloon can be fabricated as one or more layers comI-ri~ing such m~tt~.ri~l~, and/or with one or more regions or portions of differing ~lu~.lies.
Those skilled in the ~lh~cnl art, given the present te~hin~, will ~plc ;aL~ the lll~U~l in which ~lGrGllGd balloons, inc1u-iin~ the m~t~.ri~ used ~o fabricate b~lloon~, will provide an optimal combination of such ~r~llies as bioco.l.~aL~bility, biodurability, strength, wall thi~kn~ss" wett~hility with a bio.,.~ 1, gas permeability (e.g., gas venting ability), puncture rç~i~t~n~ e, comp1i~nce, flexibility, modulus of P1~ticity, stress/strain curve yield point, burst UlC, m~ximllm inflation, and the ability to be easily f~hric~ted and sterili7~d.Examples of suitable balloon m~teri~ in~ , but are not limited to, solid . polymeric m~tPri~1~ such as me...bl~nes. Such polymeric m~tt~.ri~ can be provided with suitable venting holes, e.g., produced by the use of ~ ~c~ laser.
r~rt;rr~ m~teri~1~ include fabrics and meshes that are ~l.,rt;l~bly also wettable by the bio..,~ 1 of choice, in order to allow the bi~ 1 to seep rough the mesh as it cures, and to bond with and/or around the threads of the mesh in order to form an integr~1 structure with the mesh. In a plcser~lly ~crelr~d emboflim~nt the res1l1tin~ surface of the filled, cured balloon is g~n.o.r~lly uniform, having portions of the fabric scrim exposed. Optionally, the m~t~.ri~1 used to fabricate the balloon can itself be provided (e.g., illlpl~~ ~ or coated) with s~lit~hle mo~ifiers capable of affecting the rate andlor degree of bio...At~.. ;A1 cure. The use of a suitable catalyst, for ;..~ nce, can serve to cure the bio~ -';
more quickly upon contact with the m~tP.ri~l, thereby providing an outermost region having different çhPmic~1 p vl)ellies in the fully cured implant.
Suitable polymeric mAt~-.riA1.~ include tol~tompric and other m~t~ri~l~
commonly used for angioplasty _nd related applications, and include polyuletl.; ..es, polyolefins, poly~mides, polyvinyl ch1Ori~les, and polyethylene W O 97J26847 PCTrUS97/00457 l~lc~ tps~ as well as various copolymers, combinations and pG~ ;C)nC
thereof.
P~cr~llcd balloon m~tPri~l~ are available commercially for use in filtration and other applications, and include clothes and meshes formed of polymeric S m~tPri~lc such as polyester, polyl,r~ lene and nylon threads. Optionally, a m~fPri~l can be reinforced, e.g., with woven glass or fine fibers of other m~tPri~1~, to provided added strength or other desirable plo~ellies. Such m~t~ri~l~
are sel~tpcl to provide an optimal combination of such pl~ ies as strength, mesh opening, thread ~ mPter, mesh count, percent open area, and cost.
Suitable m~tPri~l.c, for in~t~nce, provide a mesh opening of between about 1 and about 100 microns and preferably beLween about l and about 10 microns.
Suitable m~t~ri~l~ further provide a thread ~ mptp~r of between about 20 micronsand about 50 microns, and a percelll open area of between about 1% and about 5%. E~a~.lplcs of particularly ~GÇellcd m~tPrt~l~ are commercially available andin~ de, but are not limited to, nylon screen cloth, such as a nylon mesh available as Part No E-CMN-5 ~5 m-icron mesh opening) from Small Parts, Inc. Miami Lakes, Fl, and from Tetko Inc.
Suitable m~tPri~1~ for fabricating the shaft portion of a ~ tr~l tinn device include polymeric m~tPri~ls that are preferably ~~hemic~tly cc,-l,palible with the balloon ~in order to f~cilit~tP attachment of the two), sllffici~Pntly strong (to will.C~ the bio,..~ l delivery ~ S:iUlG), and snffici~ontly flexible and inert in order to f?~ilit~t~P their use in vivo while positioning the balloon. A shaft can be of any desired t1imPn~ion~, e.g., on the order of S to 10 cm in height, 2 to 5 mm, and preferably 3 to 4 mm ~YtPrn~l rli~metPr, and lmm to 4mm, and preferably 2mm to 3 mm inner ~ mpt~pr~ with wall thicknPs~ of on the order of 0.3 mm to 1 mm.
The balloons thPm~Plves can be fabricatPd by a variety of means. In one ~i~fe~n d Pmho-1imPnt the balloon is formed as a continuous (e.g., unitary) and non~ G~ ~d (e.g., se~mles~) form, and optionally, as an intPgt~l part of the dis~al end of the delivery shaft. A membrane m~tPri~l can be formed, for CA 02244l97 l998-07-22 W O 97/26847 PCTrUS97/004~7 in~nee, by poeitic nin~ it over a suitably shaped mandrel under suitable conditions of time and lelll~ldlulG in order to cause the membrane to po. .,.~nPntly conrG~"~
to the shape of the mandrel.
In a,loLl,e~ fGllGd embo~lim~nt, the balloon is fabricated from a plurality of g~nPr~lly sheet-like portions, which can be assembled and sealed ~c-ge~
Sealing can be accompli~h~ by any suitable means, ;nçl~ in by the use of adhesives, sewing, RF bonding, heat sealing, impulse sealing, and any comhin~tior~ thereof. A particularly pr~r~ied seal is provided by RF bondlng following by a bead of a co..~alible adhesive capable of ~lulaling the bond.
Once sealed, the balloon is ~lGrGl~ly turned inside out in order to provide the sealed seam on the interior of the re~lllt~nt balloon.
The balloon can be fabricated to assume any desired shape upon infl~tinn, and in a yl~rel~d embodiment is provided in a generally ovoid shape, and preferably in the a~ shape of a kidney bean, in order to ap~n,,~;m~tP the l~i natural anatomical shape of the disc space itself. Preferably, the balloon provides two major s~ s for cont~rting ~ e velL~ldl end plates ~acing the disc space. The balloon further provides wall portions for contact with the annular shell within the disc space.
The ~1im~n~inne of the balloon will typically vary according to their intPn~e~ use. For use in the lumbar region of an adult male, for inet~n-e, the infl~t~l b~llc~n will typically have a lateral ~lim~on~ion of b~w~n about 20 mm and about 40 mm, and preferably between about 25 mm and about 35 mm, as well as an al~t~,ior/~o~ r ~limPneion of between about 15 mm and about 25 mm, and will inflate to between about 10 mm and about 15 mm in height for use in distracting the space. For the cervical region and thoracic region these llimPn~ione will be a~ v~ ly one-half, and three-fourths, respectively of the lumbar ~limPn~ionS.
When provided as a separate component ~ hPA to a delivery shaft, the bal~oon will preferably also include an integral stem or cuff portion or a region WO 97126847 PCTrUS97/00457 having a reduced ~ metPr (e.g., on the order of S mm to lQ mm) for use in ~chin~ the balloon to the distal end of the shaft.
A s--it~hlP mP~h~nic~l ~tt~rhmPnt for sP~llrin~ the balloon to the shaft involves tightly Wld~il~g the end of the balloon with a fine thread or suture toprovide a seal between the balloon and shaft. The balloon can be ~tt~rhP~l othermeans as well, e.g., by gluing, ~ttaehing, or intPgr~lly forming the balloon and/or a stem ~tt~chçd to the balloon to the cannula end. Optionally, the balloon is z~tt~che~ to the shaft by means of an integral stem, which preferably provides aregion that eYtPnds from the shaft and is lm~p~lp~d~ in order to provide a useful site for s~p~dlil~g ~e.g., cutting) the balloon from the shaft.
Preferably the ~ tr~rtinn device (e.g., either the balloon and/or the shaft portion) is provided with one or more oriPnt~tic)n ,llalh~,~, in order to permit the ~uly,eon to determine the optimal orient~tion of the balloon in situ. Suitable ori~-nt~tion .I-alh~ inrl~lde, but are not limited to, the pl lcempnt of clete~t~ble Ol in~lir~tions within or upon the balloon m~fPri~l and/or c~th~Pter, the m~rking~ or inrlic~ffnns thPm~e1ves being ~iP,tect~hle by minim~lly invasive means, e.g., by fiberoptic vi~ li7~tion, i~ltelopeld~ive m~gnPtir r~son~-ce im~ing ~, ultrasound, and laser radiation. The position of the shaft ~tt~rhmPnt to the balloon can itself be dçcignP~1 so as to permit the surgeon to properly place the balloon in the desired location in the course of surgery.
The llninfl~t~ balloon is ~lert;ldl)ly pO~itif necl within the annular shell, f~llowing (li~c-p~lnl~ly~ As described above, merh~ni~l distraction of the spacecan be used as well, e.g., either while inserting and/or positi~ ning the balloon andfor during inflation of the balloon with bio,n~f ;~1 A suitable ml~h~nir~l tl;str~rtinn device for this purpose includes the use of a plurality of pins (e.g., screws~ that can be placed in the opposing vertebrae and gra~ with a matable in~llulllen~, e.g., having a scissors-like grip and move,llel,l.
Once in place within the disc the balloon can be filled by having the shaft 3~1 connect~ to a bio~ te, ;~l delivery device capable of del;vering biom~trri~l W Og7126847 PCT~US97100457 through the shaft and into the balloon under snfflci~nt ~lGSi,ul~, optionally with mPrh~nic~ tr~rtion, to expand the balloon and distract the space. When in the form of a two-part curable polyulell.alle as described herein, the bio.n~ 1 willbegin to cure as it leaves the mixing çh~mher of the delivery device. It will con*n--e to cure as it plvgl~ses through the shaft and into the balloon. Ideally, the cure rate of the biopolymer is controlled, in co~ lation with the flim~n~ionc and other con~litions of the ~ tr~ction device, in order to provide s~-fflci~nt time for the bio."~ 1 to expand the balloon before final curing occurs. The distraction plogress can be monilolGd, e.g., by C arm cine or in~c..,~L~ti~e MRI.
Finally, the shaft can be removed from the inserted, infl~t~d and cured balloon~bio."~ l combination by any suitable means, e.g., by cutting the stem of the balloon using surgical means, or by heating a wire that has been previously ernhe~l~ in or around the circumference of the balloon stem.
Riomateri?~ls N~tural cartilage is a non-vascular ~llucLuf~ found in various parts of the body. Articular cartilage tends to exist as a finely gr~n~ r matrix fc-rming a thin in~...~ , on the ~. r~c~s of joints. The natural e1~tici~y of articular cartilage enables it to break the force of concuq~ion~, while its smoothness affords ease and freedom of movement. Preferred b~ r~re, are int.on~1~d to mimic many of the physical-chemical char~ tpri~tics of natural cartilage. Bio.~,~t~
can be provided as one component systems, or as two or more COIIIPOneJ~ S
that can be mixed prior to or during delivery, or at the site of rep~ur. ~Pner~lly such bio,--~t~ are flowable in their uncured form, m~ning they are of sllfficienf ViSCQSity to aUow their delivery through a c~nn~ of on the order of about 2 mm to about 6 mm inner ~ meter~ and ~lc;Çel~bly of about 3 mm to about 5 mm inner ~ mPtPr. Such bio",~t~ are also curable, mP~ning that they can be cured or otherwise mt clifi~7 in situ, at the tissue site, in order to undergo a phase or chPn-ic~l change sllfficient to retain a desired position and configuration.
When cured, ~ler~led m~t~ri~l~ can be homogc -eous ~i.e., providing the same chPmic~l-physical p~r~mptprs throughout), or they can be hel~logeneous. An W O 97126847 PCTrUS97/004S7 eY~mp1e of a heterogeneous biom~t~.ri~l for use as a disc repl~r~m~nt is a biom~tt~ri~l that mimics the natural disc by providing a more rigid outer envelope (akin to the annulus) and an more liquid interior core (akin to the nuclel~). In an re emb~iim~nt~ bio.-~ can be used that provide impl~nt~ having varying regions of varying or different physical-chemiç~1 p,~ ies. With disc repl~r~m~nt, for inst~nre, bio~ r~ i~ls can be used to provide a more rigid, annulus-like outer region, and a more fluid, nurleJI~-like core. Such di-or higher phasic cured m~t~isils can be ~l~al~d by the use of a single bio...~ l, e.g., one that undergoes varying states of cure, or a plurality of bio...~
Common polymeric m~tlori~l~ for use in mf~Air.~l devices include, for e-~mple, polyvinyl chlorides, polyethylenes, styrenic resins, poly~lu~ylene, thermoplastic polyesters, thermoplastic el~tc-m~rs, polyc~ul,onatGs, acryl- nitril~-but~ n~o--styrene ("ABS") resins, acrylics, polyulG~Ianes~ nylons, styrene acryloni~ s, and cellulosics. See, for example, "Guide to M~li~l Plastics", pages 41-78 in Medical Device & Di~nostic Industry, April, 1994, the ~ losl~re of which is incc"~ol~led herein by reference.
Suitable biom~t~-.ri~ls for use in the present invention are those polymeric m~t~ri~l~ that provide an optimal combination of ~lu~lhes relating to their m~nllf~tllre, applic~tion~ and in vivo use. In ~e uncured state, such p~ol~Gllies include processability, and the ability to be stably st~.ri1i7~d and stored. In the course of applying such m~t~ri~t, such ~,u~llies as flowability, moldability, and in vivo curability. In the cured state, such pl~c;llies include cured strength (e.g., tensile and co~ essive), stiffn~e~ biocompatability and biostability. FY~mples of suitable bio~ include, but are not limited to, polyulcll~e polymers.
In a plt;rell~ emborlim~nt, the biom~tPri~l comprises a polyu~ c polymer. Poly~ n~s, e.g, thermoplastic polyur~ es (" l~U"), are typically cd using three re~r-t~nt~ an isocyanate, a long-chain macrodiol, and a short-chain diol eYt~n~er. The isocyanate and long-chain diol form a "soft" segm~nt, while the isocyanate and short-chain diol form a "hard" segm~.nt The hard segmPnt~ form ordered domains held together by hydrogen bonding. These W O 97126847 PCTrUS97/00457 domains act as cross-links to the linear chains, making the m~tpri~l similar to a cross-linked rubber. It is the int.~ tinn of soft and hard segmPnt~ that determin~s and provides the polymer with rubber-like p.~ lies.
S Those skilled in the art, in view of the present invention, will a~.~;a~
the ~ L in which the choice of isocyanate, macrodiol, and chain eYten-ler can be varied to achieve a wide array of pl~c;l~ies. ~l~r~ d TPU's for mPAtr~l use are presently based on the use of a diisocyanate such as diphenylmP-th~nP
diiso~y~,dle ("MDI"), a glycol such as polytetr~m~thylene ether glycol, and a diol such as 1,4-bllt~nP~
In an further pl~f~llcd emb~limPnt the bio.~ 1 compri~es a thermosPfflng polyureLll~le polymer based on a suitable cc~lllbil-dLion of iso~;yd,~aLes, long chain polyols and short chain (low mo1o~c~ r weight) eYten~Pr~
and/or cro~link~-rs Suitable col..~onents are commercially available and are each ~lc;rt;ld~ly used in the highest possible grade, e.g., reagent or pf~r~bly analytical grade or higher. ~Yamples of suitable iso~;y;~lales include 4,4'-diphenyl mPth~nP
siiiso~y~ale ("MDI"), and 4,2'-diphenylmPth~ne diiso~;y~ulLe, in~ ling ~ Lu~
thereof, as well as toluene diiso~;y~.dle ("TDI"). FY~mrl~s of suitable long chain polyols include tetrahydl~ru-~l polymers such as poly(tptr~mpthylene oYide) ( PI~MO"~. Particularly p~efe--~d are combin~tion~ of PrMO's having mol~ r weigh~s of 250 and 1000, in ratios of between about 1 to 1 and about 1 to 3 parts, r~ecLively. FY~mrl~s of suitable eytp-n~p~rs/cro~ nkp-r~ include 1,4-bl-t~n~lioland trimethylol p~ c, and blends thereof, preferably used at a ratio of 1)~
about 1 to 1 and about 1 to 7 parts, respectively.
P~i~""~ of the present invention can also include other optional adjuvants and additives, such as stabilizers, fillers, antioxidants, catalysts, pl~tici7Prs, pi~m~nt~, and lubricants, to the extent such optional ingredients do not ~limini~h the utility of the co..l~o~iLion for its intenflP~ purpose.
When cured, the bio.~ demon~ t~ an optimal combmation of physi~ chPmic~l properties, particularly in terms of their confo,~ Lional stability, -WO 97~26847 PCT~US97/00457 ollltion stability, bioco,..pa~bility, and physical ~e.ro~ ce, e.g., physical prop~.~ies such as density, thickness, and surface ro~ hne.~, and m-~hz-ni~1 ~ropellies such as load-be ring strength, tensile strength, shear strength, fatigue, impact absol~lion, wear cha~teri~tics, and surface abrasion. Such pe rol---allceS can be evaluated using procedures commonly accepted for the evaluation of natural tissue and joints, as well as the evaluation of biom~tPri~
In particular, p-ef~,llGd bio.~ e.;~1~, in the cured form, exhibit ~ .h~ni~
Lies that ~ xim~t~. those of the natural tissue that they are intontl~ to replace. For in~t~nce7 for load bearing applications, ~rert;.lGd cured composites e~hibit a load bearing strength of between about 50 and about 200 psi (pounds per square inch), and preferably between about lO0 and about 150 psi. Such composites also exhibit a shear stress of between about lO and lO0 psi, and preferably bG~weGn about 30 and 50 psi, as such units are typically del~-- ...in~d in the evaluation of natural tissue and joints.
Preferred biom~t~ri~1~ are also stable under con~lition~ used for ~,t~ri1i7~ticm, and additionally are stable on storage and in the course of delivery.
They are also capable of flowing through a delivery c~nm-1~ to an in vivo location, and being cured ~n situ, as by exposure to an energy source such as ultraviolet light or by çh~mi~~1 reaction. Th~learLer the cured biom~tp~ l is suitably ~mPn~le to shaping and eonlou,illg, by the use of conventional or custom ci~nPd alLlll~sco~ic tools or instruments. Over the course of their use in the body the cured, contoured biom~tPri~1 exhibits physical-c.ht-mic~1 plu~;lLes s1-it~h1e for use in extended in vivo applications.
In a plt;r~;lled embodiment, the bio...~ 1 is a polyun,ll,al e provided as a two-part prepolymer system comprising a hydr~,gellal~d MDI isocyanate, polyethylene~polypropylene oxide polyol, and l,4-b~1t~nPAio1 as a chain eYt~.n~ler.
The final polymer having a hard segment content of about 30 to about 40% by weight, based on the weight of the hard segmPnt Thixotropic agents, such as thatavailable under the tr~-lPn~me "Cab-o-sil TS-720" from Cabot can be, and W O 97126847 PCT~US97/00457 preferably are, usPA to achieve the desired flow and pre-cure viscosity characteristics .
Optionally, and preferably, one or more catalysts are incorporated into one or more co~ onents of the biomaterial, in order to cure the biom~tPri~l in the S physiological environment within a desired length of time. Plert;~dWy, hio,..~ lc of the present invention are able to cure (i.e., to th-e point where distraction means can be removed and/or other bio,~ 1 added~, within on the order of S minlltes or less, and more preferably within on the order of 3 I.l.n~lt'S
or less.
~Lef~ldbly, means are employed to improve the biost~hility, i.e., the oxidative andJor hydrolytic stability, of the bio..,~ei;~l in vivo, thereby PYtçn~lin~
the life of the imp1~nt See, for in~t~nce, A. Tz~k~h:lr~l, et al., "Effect of Soft .Segm~nt l~hPmi~try on the Biostability of S~mPnt~P~ Polyul~ nPs. I. In vitro Oxidation", J. Biompslic~l Materials Research, ~E:341-356 (1991) and A.
Tslk~h5~r:l~ et al., "Effect of Soft Segment Chemistry on the Biostability of Sç~mPnt~d Polyulc~ Ps. II. In vitro Hydrolytic DeF~ hcn and Lipid Sorption~, J. Bion eAi<~ teri~1s Research, 26:801-818 (1992), the ~ closllres of both of which are incolL,oldted herein by reference.
Suitable means for improving biostability include the use of an ~liph~hr~
macrodiol such as hydrogens~tçd polybu~iene (HPDI). By judicious choice of the culr~onding diiso~;y~la~ (e.g., MDI) and chain eYtP-nflçr (e.g., ethyl~nP~ minP), those skilled in the art will be able to achieve the desired p~king density, or crystallinity, of the hard s~..,~ , thereby improving t~e hydrolytic stabili~y of the cured polyul~ e.
Biom~t~Pri~l~ provided as a plurality of co~ onents, e.g., a two-part polyure~ e system, can be mixed at the time of use using suitable mixing techniques, such as those commonly used for the delivery of two-part adhesive formulations. A suitable mixing device involves, for in~t~nce, a static mixer having a hollow tube having a segmçnted, helical vein lunl~iilg through its lumen.
-W O 97/26847 PCTrUS97/00457 A two-part polyurelll~le system can be mixed by forcing the lG~ecLi~re C~"'~ on~Qnt~ through the lumen, under pn s~..l~.
In a further embo limPnt the static mixer can be used in a system having an appli~tic~n ç~nmll~, an aprlic~tion tip, and a cartridge having two or more S cl~."k~- ~, each co~ inil-g a s~aldle ColllpollGIlt of the biom~tPri~l system. A
hand-powered or çl~trie~lly controlled extrusion gun can 'oe used to extrude theco.-,~~nents through the static mixer, in order to completely mix them and thereby begin the process of curing. The biom~tPri~l system then flows through the ~nmll~ and to the joint site or surface through the application tip. The length,~i~metPr, and vein design of the mixing el~mPnt can be varied as n~e~ r to achieve the desired mixing efflciPncy.
F~y~m~ ç
In pGlro~ g a ~rGfGllGd method of the present invention, the patient is brought to the pre-surgical arça and prepped. ~nPsthP~i~ is then in-~uced and the area of the spine is further prepped. A small inci~inn ~ong the p~inal mll~lP~
is opened under ~ c*ng microscopic vi~ li7~ticn The incision typically ranges betweçn 3 and 6 cPntimPt~rs in length and is longit~ in~l in the plane of the spine.
The paraverte50~al muscles are s~?aldted by blunt ~ ctinn and held apart with forceps and dividers. The intervertebral disc area is vi~u~1i7PA, with initial exposure down to the lamina. The ared below the l~min~, at the point of the intervertebral foramina, can also be exposed.
The disc is PY~min~d for extruded m~teri~l and any extruded m~tPri~l is removed. Mzl~nPti~ ce im~ging ("MRI") data can be used to ~le~ - ...il-~- the i~ltegliLy oiF the ~nm~ fibrosis at this point. An a,~ oscope is inserted into the disc and used to eY~minP the inside of the ~nnn1lls. Optionally, an intra~)pc.dLivc;
~i~g, ~ can be ~elrc,ll--ed, in which a dye m~tPri~1 is inserted and vi~n~li7~d in order to ~.lb~L; ,-~ the integrity of the ~nmlllls fibrosis. Points of we~kness, or ,. rents, in the ~nmlllls fibrosis are i(lentifi~1 and located and suitable means, e.g., a bin~l-so,bable glue is employed to block these rents.
Di~tr~tic)n of the in~clvclLPI)l~l disc space can then be accompli~h~, as rle scrihe~ above. Once under traction, a bio..~ l, e.g., biopolymer of the present invention is introduced to the distracted space. The polymer is preferably cured over 3 to 5 minutes, and preferably within 1 to 2 ~ lr.s The ~ll-~osccpic c~nn~ and the applic~tion ~~nnlll~ are removed. The m~tPri~l is further aUowe~
to harden over 15 to 20 ...i...ll~s and the disc traction is removed.
The desired quantity of the curable bio...~ l is delivered by minim~lly invasive means to the plc~alc;d site. Uncured bio...~ 1, either in ~uLt~ or in the form of sep~-,-lP reactive components, can be stored in suitable storage c~nt~inpr e.g., sterile, teflon-lined metal c~ni.~t~ors. The biom~tt~ri~l can be delivered, as with a pump, from a storage canister to the delivery c~nnlll~ on dem~n-~.
Biom~t~ri~l can be delivered in the form of a single co~ osiLion, or can be delivered in the form of a plurality of co~ onents or ingreAiPnt~ For in~t~nce, bic~ te.;71 co.~l~onel-t~ can be sep~Mt~ly stored and suitably mixed or combinedeither in the course of delivery or at the injury site itself.
In terms of its col,.pollellt parts, a plcfelled delivery system of the present invention will typically include a motor drive unit, with a remote controller, teA tube sets, a nonscope inflow delivery ~nmll~, having independent fluid dynamics ~ '7i:iUle and flow rate adj.l~l---~-~t~ hm~nts for the flush, vacuum, waste ç~ni~ter, and overflow jars.
The application c~nmll~ is inserted into the joint or disc space and under vi~ tit n from the fiberoptic scope the bio~ lr, ;~l is delivered. The flow of the biom~~ri~l is controlled by the operator via a foot pedal co~ ~;l~ to the JUll~pil~g m~rh~ni~m on the polymer canister. The biom~t~ri~l flows from t-h-e tip of the application catheter to fill the space provided.
The delivered bio...~ ;;.l is allowed to cure, or cured by minim~lly invasive means and in such a manner that the cured bio.~At~ 1 is retained in apposition to the ~ d site. As described herein, the bio..~ 1 can be cured by any suita~le means, either in a single step or in stages as it is delivered. Once CA 02244l97 l998-07-22 W O 97/26847 PCTrUS97/00457 cured, the bio...~t~ 1 surface can be contoured as needed by other suitable, e.g., endoscopic or ~ ~llvsco~ic,instrl-m~nt~ The joint is i~ig~t~d and the in~u,..e removed from the portals.
At that point, in~l~e~ e x-rays are obtained to ~ul~ te the preservation of the intervertebral disc space. Direct observation of the in~l~ l Çc..,~ for free cursing of the nerve rootlet is ~sl;."1;i.~ by vi~n~1i7~ti~n. The retr~ct~ m~ s are replaced and the local fascia is closed with inl~.lu~led absorbable suture. The sub~;ul~ ~us fascia and skin are then closed in the usual f~hion The wound is then dressed.
As mPntil~n~d above, the cured bio~ Al can be subjected to further physical~ch~mie~1 modifications, e.g., in order to ~nh~n~e it ~Lîo..~ ce, bioco---pa~ility, biostability, and the like. For instance, calcitonin and infl~ oly inhibiting molecules such as Tnte~le~1k~n I inhibitors can be ~tt~rhecl to the bone co~ osiLe surface to prevent local osteoporosis and local inn~
response which may cause loosening. Simil~r1y, the surface of the cured bic,...;~ 1 can optionally be modified in order to alter, e.g., reduce, its lubricity or coefficient of mctinn-Diarthroidal and A-1-~hia~ roidal Joints.
The method and bio...~ 1c of the present invention can be used for the repair of other tissues and joints as well, inc1l1-1ing, for in~t~nce, the glenoid surface of the shoulder, the first carpomet~l ~rpal joint of the hand, the knee, the l~ip, the hallux joint, the le---pol~l mandibular joint, the subtalar joint in the ankle, the other ~lle~l ph~1~n~eal ioints of the feet.
With respect to the shoulder, for in~t~nce, a common situation arises in the elderly patient who has a degenerated rotator cuff. Usually, such p~tient~ have lost the superior portion of the rotator cuff with the complete loss of the ~tt~ tendon. Often they also have a superior riding of the humerus so ~ that it art~ tP.s very high on the glenoid and with any abduction there is ~i~nifi~nt imrin~em~nt on the acromium process.
CA 02244l97 l998-07-22 W O 97126847 PCTrUS97/00457 Using the a~p-~,acl- pl~;senlly described, a biom~teri~l can be delivered, cured, and ~tt~hPd to the g1PnQj~, all using minim~lly invasive means, in order to resur~ace the glenoid surface and extend up over the superior portion of the humerus. There the cured biom~tPri~1 will act as a spacer between the humerus S and the aclo~liu~ process. I~es~ ing the underside of the acfv.,liu,., and the glenoid with a single structure that allows the humerus to be spaced down from the acrvll~iulll process and to avoid impingement on the ac~ lliul~ with a~duçtion-Other areas of the body that will also benefit from the creation of a spacer, yet do not involve ~ignif~ nt weight-bearing con.ctr~int.C, include the first carpom~a~rpal joint of the hand, the r~ h11mPr~1 joint. The method of the present invention can be used to provide a spacer that will allow motion with a minim~lm of friction, while also providing desired mech~nic~l stability to the area.
Yet other applications include repair of the first carpomet~ rpal joint, which is another dia,lhloidal joint. The carpal bone and the base at the ...e~ al are normally covered with articular cartilage. Ihis joint, however, is subject to ~ignific~nt degenerative change over time because of stresses that are placed on it by normal hand motion. Ihese stresses can result in a na.lowing of the joint space and eventually a bone-on-bone situation, with m~rk~d loss of motion and ~ignif~ nt Such a joint can be repaired by minim~11y invasive means using the method of the present invention, e.g., by placing an ~ iate spacer of bi~ r-li31 through the arthroscope and ~M~in~ it to one side or the other of the~oint.
In such a procedure, two small holes can be drilled into the base of the mPt~ rpal, for inst~nCe ~urable biom~ttori~1 can then be applied into those anchor points and over the surface of the base of the mPt~ rpal. The final curedbiom~t~ri~1 provides both a cushioning and a spacing function, which will serve to decrease p~in and improve motion and filnction Yet another joint that is amenable to repair using the present method is the hallux joint, also known as the metatarsal phalangeal joint. In a condition called hallux rigitlit-1s, the cartilage between the base of the 1st phalanx and the end of W O 97126847 PCT~US97100457 the first mPt~t~r.~1 has degenerated and there are ~ignifiç~nt bony spurs forming due to the degçn~dlil~n of the cartilage. As with the first c~u~o...~-~;.r~rpal joint at the wrist, the method of this invention can involve arthroscopically drilling a plurality of small holes in the head of the metatarsal and delivering and curing a bio",~ l to produce the needed cll~hioning and sr~in~.
Yet other areas of application include the rll,luc~lilage of the lelllPU~
mandibular joint, cGslocl ondral junctions, and the acromioclavicular joint.
Another application involves the subtalar joint in the ankle. This is a common area for medial subluxation of the anle in the patient with rhP~Im~toid arthritis who gets s~-Glchillg and w~kt-ning of the tibialis posterior tendon and instability at the medial aspect of the ankle, res--~ting in persistent anlde pain. A bio".~le. ;~l and m~thol1 of the present invention can be used to build up the subtalar joint area in order to realign the anlde and correct the eversion of the foot, thereby ol,~ialing the need for an ankle fusion.
Ihe for~going description is intPn-l~P~1 to be illustrative of the invention, but is not to be considered as cc,ll,~rehensive or timitin~ of its scope.
W O 97/26847 PCTrUS97100457 ARTICULATING JOINl~ REPAIR
TECHNICAL FIET n The present invention relates to mtothorls~ a~ es, m~t~P-ri~l~ and IIIS for the repair of movable and mixed arti~-ul~ting joints in the body.
CROSS-REFERENC3~i TO RELATED APPLICATIONS
This applir~tinn is a contin~l~tinn-in-part of U.S. Applic~ti--n~ having Serial No. 08J590,293, filed January 23, 1996, which is a con~ ;Qn-in-part of Serial No. 08/239,248, filed May 6, 1994 for JOINT RESURFACING ~Y~
BACKGROUND OF THE INVENTION
The joints of the body can be clq~ifieA as be~ween those that provide immovable artic~ tion~ (syll~lluidal)~ mixed artir~ l~tions (an~ i~Lllloidal), and movable articnl~tiQn~ (diarthroidal). The ability of ;~ hi~ uidal and <li&Lllll~idal ~oints to provide ~rî~;Live and pain-free artic~ ti~ n, and/or to serve their weight-bearing function, is gener~lly dependent on the presence of intact,healthy r~l,r~c~lilage and/or hyalin cartilage within the joint.
In an ~ oidal joint such as the lumbar joint of the back, the are se~dled by an intervertebral disc formed of rll"~Lilage. More palticularly, the intervertebral disc is co..,l.. ;~PA of an outer ~nnnlll~ fibrosis formed of fibrocartilage. The ~nnllll-~, in turn, surrounds and contains a more fluid m~tPri~1 known as the n~lcle~ls pulposus. By virtue of its fluidity, the n~c leus allows ~or both movement and weight-bearing energy transfer. In healthy, generally you- g~ individuals, the ~nntll~ls is intàct and the nllrleNs pulposusremains quite fluid.
As people age, however, the ~nnlllll~ tends to thic~-n, desic~r~tto, and become more rigid. The nucleus pulposus, in turn, becomes more viscous and W 097126847 PCTrUS97/00457 less fluid and so...~t;.~Ps even deh~dldtes and contracts. The zinnllllls also becomes susc~L~Lible to Ll ~;L~ or fic~nring. These fractures tend to occur all around ~he ch-;u",re~ ce of the zlnn~ 5, and can extend from both the outside ofthe z7nm~ s inward, and from the interior ouLw ~. Ocr;icionz11y, a fissure from ~e outside will meet a fissure from the inside and will result in a co".~leLe rent through the ttnn~ c fibrosis. In a situation like this, the nUclells pulposus may extrude out through the inter~.Lebldl disc. The extruded m itPrizll, in turn, can impinge on the spinal cord or on the spinal nerve rootlets as they exit through the in~lveLLe~l~l foramen, res~-ltin~ in the sy~ o-lls zic~ocizttP~ with the classic"ruptured disc".
The current surgical approach to treating a deg~nto.r~SP~l intervertebral disc g~nPrzilly involves the process of micr~ cectomy~ in which the site is z~ccPc~P~l and the protruded mzit~rizll is removed. This often produces .ci~nificzlnt relief, provided it is a fairly minor, or mild, lC!rZtli7f'~l disc ~ u~;on. In such a ~ U1~ a small in~i~ion iS made, through which the disc is vicuzlli7Pfl~ The areaof protruded mz tt-rizil iS removed, thus decoll,~l~s~.ilg the nerve rootlet that has been impinged on by the extruded mzit~.riz~l.
In more severe situations, however, the ~nn~ c fibrosis becoll,es ~lcge--e.~ fl to the point where very little disc space remz inc, and much of the nll~leus plllrosus is ei~er con~,~l~ted or has been extruded. l?P~ior~zil os~opl.yles can also develop around these areas. The combinzlti~ n of the extruded mzlt.ortzll and the osteophytes, together with the narrowing of the intervertebral disc space produces a mztrk~Yl n all.,willg of the intervertebral foramen and impin~em~n~ on the spinal nerve rootlet as it exits the canal. This is the cl ~cci~l situation that results in radicular pain with axial loading.
When this occurs it becomes nPcçc~t.y to reestablish the intervertebral space. The current approach to this more severe situation is a lumbar l~tminP~ctomy (to decol,-p~ess the nerve rootlet) with fusion of the disc space. The bony lamina is removed to decompl~ the intervertebral f~ ;n~ and the bone graft is taken from the anterior iliac crest and attached from one v~leblde body to W O 97/26847 PCTnJS97100457 the next. The rçs--ltin~ fusion will ..~int~in stability at that point and also help in the s~aldtion of the vertebrae.
Recent advances in this technology have been developed by such co.. ll~nies as Spine-Tech, MinnP~I olis, MN, which involves the use of a ~ i,l ll alloy S cylinder. The cylinder is screwed into the intervertebral space to assure the stability of the spacing until a fully bony ankylosis can be obtained. The cylinders are packed with bone and are fenestrated so that the packed bone can grow out into the ~ rPnt ve.L~ de and solidify the fusion. To date, however, clinical results on the long-term follow up of these p~tiPnt~ are not available and the efficacy is still in doubt with many spine ~ul~ eons.
It would Ll,er~lc be particularly useful to be able to repair such injuries in a Ill~mef that avoids invasive surgical procedures and the problems ~oci~tr~d SUMMARY OF THE INVENIION
The present invention provides a method and related m~tr-,ri~1~ and ?CLld~us for using minim~11y invasive means to repair ~e.g., reconstruct) tissuesuch as fibluca Lilage~ and particularly fibloc~ilage ~ori~tPJl with di~ uidal and ~mphi~rthroidal joints. The method involves the use of minim~lty invasive means to access and ~r~p~t; r1~m~r~1 or ~ ed fibrocartilage within the body, and to then deliver a curable bic.",i~t~ 1 to the pr~ d site, and to cure the biom~tPri~1 in s~n~ in order to repair the fibruca lilage and replace the function of the rl~m~E~Pd cartilage. The bio",~r~ 1 provides an optimal cc.".~ l;nn of such l..u~l~ies as deliverability and curability, as well as bioco~ atability, biostability, 2~ and such physical pelrui.. ~nre char~cteri~tirs as strength, el~ticity~ and lubricity.
In one embortimr-nt, the method comprises the steps of:
a~ using minim~lly invasive means to remove rl~m~gr-cl or ~
fibrocartilage from a di~hLl,loidal or anl~hia ll-lùidal joint, and to create a mold capable of co~ ;n~ curable biom~teri~1 in a desired position within the joint, W 097/26847 PCTr~S97/00457 b) providing one or more curable biom~tPri~l.c to the structure previously occ~piPA by the removed fiblu~hLilage, and c) curing the biom~tPri~l.e in order to provide a repl~rPmPnt for the fibl~ Lilage.
S The mold created within the joint is preferably of s-lffi~.irnt shape and imPneion~ to allow the res~-l*n~ cured bio...; ~ 1 to replace or mimic the structure and function of the removed rlbl~lilage. The mold can be formed of synthetic andJor natural m~t~ri~l~, including those that are provided eYn~.nously and those provided by the rP.m~ining natural tissues. The mold c~n either be l~ lo~ed from the site, upon curing of the biom~tPri~l, or is sllfficie-ntly bioco~ hle to allow it to remain in position.
The mold can take the form of either a positive and/or negative mold. For in~t~nce, the mold can take the form of an outer shell, capable of lel .il,;,.~
biom~t.o i~l within its interior cavity. Optionally, the mold can also take any other suitable form, incl~Ain~ to serve as an interior core (e.g., to create a doughnut shaped biom~tpr~ or as an anchor point for the stable ~tt~chm~-nt and loc~li7~tion of delivered bi~
In a particularly ~ler~.~ed emboAimPnt, the m.othod is used to repair an amphiarthroidal joint such as an intervertebral disc and compricps the steps of:a) using mic~ L~ical techniques to ~lr~,r-n a ~licce~;L~ y while preserving an outer annular shell, b) providing one or more curable bio...~t~ to the interior of the annular shell, and c) curing the bio.,l~ in order to provide a re~ r~mPnt disc.
In such a ~lefc.l~ emboAim~nt the distraction of the disc space is accomplished by means of a suitable Aictr~rtion means, such as an inflatable, yet rigid, balloon or bladder. The balloon can be delivered in defl~t~d form to the interior of ~e ~nn~ and there infl~tP~d in order to distract the disc space and provide a region for the delivery of bio"~ 1 The balloon is pl~;re.~bly of W O 97/26847 PCT~US97/00457 _ 5 _ snfficiPnt strength and suitable rlimPn~ions to distract the space to a desired extent and for a period long enough for the bio...~ 1 to be delivered and cured.
In a pç~r~.led embotlimPnt the invention provides a fli~tr~tion device cqmpri~ing an insertable, defl~tP(l balloon formed of a self-venting, biocc"l~a~ible material capable of re~ i"g polymer and ~ tr~tin~ a joint space at up to about 10 ~tmo~rhPre pl~S~
In other ~pP~ct~, the invention provides biom~tPri~1~, inflllfling polymer systems, useful for ~lÇo~ ing such a mPthod, as well as mPthorls of pf~ g and using such bio..~ . In yet further aspects, the invention provides a diarthroidal or ~mphi~ . lhl~idal joint having interposed therein a biom~tPri~l that has been cured in situ.
DETAILED DESCRIPIION
Appli~nt~ have discovered a means for proc~lcinf~ spinal Cp~ t;on to achieve pain relief, which involves the step of interposing cured biom~tP-ri~l in the intervertebral disc space.
Definitions As used herein the following words and terms shall have the mP~nin~
ascribed below:
"repair" will refer to the use of a biol--~r-;~l to replace or provide some or all of the structure or function of natural tissue in vivo, for in~t~n~e, to repair (e.g., reconstruct or replace) cartilage, such as fibrocartilage, present in a di~~ idal or amphiarthroidal joint. Repair can take any suitable form, e.g., from p~t~hing the tissue to replacing it in its entirety, preferably in a manner that reconstructs its native ~limen~i~)ns;
"bio..,~le,;~l" will refer to a m~tPri~l that is capable of being introduced to the site of a joint by minim~lly invasive means, and be cured to provide desiredphysic~-chPmic~1 plo~.~ies in vivo;
"cur~" and inflP~tions thereof, will refer to any chPmi~ ~l-physical tran~rol.lla~ion that allows a biom~tpri~l to progress from a form (e.g., flowable W O 97/26847 PCT~US97/00457 form~ that aliows it to be delivered by minim~lly invasive means, to a more permanent form for final use fn vivo. When used with regard to the method of theinvention, for inctAnce, "curable" c_n refer to uncured bic,...~ 1, having the potential to be cured in vivo (as by the application of a s~ hl~- energy source), as S well as to a biomAt~-ri~l that is in the process of curing, as with a bi~ t- ;Al formed at the time of delivery by the cc,ncurrent mixing of a plurality of biomaterial co,ll~onents;
"minim~11y invasive means" refers to surgical means, such as mic~ ul~,ical or endoscopic or ~LIlrosco~ic surgical means, that can be accomrlich~d with minim~l disruption of the pertinent musculature, for in.ct~nr,e, without the need for open access to the tissue injury site or Llll~,u~1~ minim~l inricionc (e.g., in-~icionc of less than about 4 cm and ~fef~.ably less than about 2 cm). Such surgical means are typically accomplished by the use of vic~-~li7~ti~ n such as rlbc~ lic or micl~sco~ic vi.c--~li7~tion, and provide a post-operative recovery time that is s~ib~ lly less than the recovery time that acco,.. ~ s the cc,l.~s~llding open surgical approach;
''PnrloscQFir-l~hLlllosco~ic surgical insLlul,lent" refers to the controllers and associaled h~lw~G and software ne~x.$.~.y for ~.rOll~ g conve~-l;o c~sc~ic or ~LII~O5c~C surgery; and "delivery e~nn~ " shall mean a cannula capable of being operated in a rninim~lly invasive fashion, e.g., under alLhl~scopic vi~ li7~tion~ togeth~r with l~ comlecli~re tubing and co~ i for the operable and fluid ~tt~hment of the r-~nmll~ to a source of bio...~ 1 for the storage, delivery, and recovery of bio."~ of the present invention.
l~ethod In a plt;rell~d embodiment, the present invention provides a method and related m~teri~l~ and a~aldlus for ~ -g di~Lllruidal and a ll~h;~~ idal joints by minim~lly invasive means. The method involves the use of minim~lly invasive means to ~)lG~al'G the site of injury, deliver a curable biom~t~ l to the joint site, and to cure the bi~ l in situ in order to repair fibrocartilage.
W O 97/26847 PCTrUS97/00457 The method of the invention can be used to repair a nul"ber of tissues, in~ ling a variety of joints, and is particularly useful for diarthroidal and llroidal joints. Fx~mr1Ps of suitable ~mpl-iA. Ihroidal joints include the synphysoidal joints, such as the joints between bodies of the vc. lel)r~e. Such joints provide s~ res connP~t~l by fil)roc~lilage, and have limited motion.
Other PY~mplPs include syntle~mo~ joints, having s~-rf~-es united by an interosseous lig~mpnt~ as in the inferior tibio-fibular joint.
F.Y~mrles of suitable di~ ,idal joints include the ginglyll~us (a hinge joint, as in the interphalangeal joints and the joint between the humerus and the ulna); throchoides (a pivot ioint, as in superior radio-ulnar artic~ tion and atlanto-a~ial joint); condyloid (ovoid head with elliptical cavity, as in the wrist joint);
reciprocal reception (saddle joint formed of convex and concave snrf~ces, as in the carpo-met~ ~rpal joint of the thumb); en~ rusis (ball and socket joint, as in the hip and shoulder joints) and arthrodia (gliding joint, as in the carpal and tarsal afic~ t-on~)~
In a particularly ~ erGlrGd embo~lim~nt the method is used to repair an Al..pl i~ oidal joint such as an intervertebral disc and compri~es the steps of:a) using miclo~u~gical techniques to ~Glrol." a di~e~lollly while preserving an outer annular shell, b) providing a curable biom~teri~l to the annular shell, and c) curing the polymer in order to provide a rep~ m~nt disc.
As can be seen, the annular shell can itself serve as a suitable mold for the deliv~l~ and curing of biom~t~ri~l Optionally, the interior surface of the annular shell can be treated or covered with a suitable m~t~ri~l in order to enh~nce itsi~ y and use as a mold. Preferably, one or more inflatable devices, such as the balloons descrihe~l herein, can be used to provide molds for the delivery ofbiom~t~ . More preferably, the same inflatable devices used to distract the joint s~ace can further function as molds for the delivery and curing of bio, . .~ . ;Al W O 97/26847 PCTrUS97/00457 Diseeclollly A Ai~ ol~y ~l.e., removal of some or all of the nucl~us plllrosis, leaving an outer annular shell~ is ~clrcrll.ed, with optional ~ tr~-finn and repair of the ~nn~lln~, in order to remove the destroyed nucleus m~tPri~l while providing an S intact annular shell. By "intact", it is meant that the ~nnullls, either alone or with optional s.,L~lling means, is of s--ffi~P!nt strength and il~leglity to retain a1 in a desired position and in the course of its use (delivery and curing).
The mielo~ulgcly for the polymeric intervertebral disc repl~mPnt can be carried out using techniques well within the skill of those in the art, given the present tP~hing. The ~nn-~ $ can be viewed, for in~t~nce, remote vi~ li7~tion techniques such as fiberoptic vi~ li7~tinn. The inLcgli~y of the annular shell is ~e~se~l, and optionally, the shell itself is lc~aired, e.g., by the application of a biocolllpaLible p~t~hing m~teri~l, such as a fibrin glue.
The destroyed disc m~tPri~l is çle~necl out and the ~nn~ is ~ ntoA. out to the edges of the ~nnnll-~ The annular shell, in~ ltling any l~paif~d portions are preferably of sllffic;~nt strength and Aim~ncions to allow the bio..~ l to be delivered and cured. The le ..~ini~g, r~ d ~nnlllll~ then serves as an outer barrier for the curable bio.. ~t~ ;~1, thereby serving to provide ~ n~
and location for the cured bio.,.~
Once the nl-c1ell~ pulposis has been removed and the lc~ ini~ nnnllls ;~dil~d, the annular shell can itself be used as an envelope to contain the delivered biom~t~ri~l. Optionally, and pl~r~ldbly, means are provided to containthe bio ~ t~ l within the desired space, e.g., by forming an ~AAition~l envelopewithin the ~nmllllc.
As used herein the word "~ tr~ction", and inflections thereof, will refer to the sep~.i.ti~n of joint s-lrf~çs to a desired extent, without rupture of their binding m~.nt~ and without displ~em~nt Distraction can be accomplished by any suita~le means. Such means include m~h~ni~l means and hydrostatic means, e.g., by ~ d injection of the biom~t~ri~l itself. By the use of distraction, the disc space can be sl~Mcipntly re-established to achieve any desired final W O 97126847 PCTrUS97/00457 _ g _ dimPn~ions and position. Optionally, and preferably, the means used to accomplish distraction also serve the pul~ose of forming one or more barriers ~e.g., envelopes) for the uncured bio...~f~ l itself.
The disc space can be ~ tr~tf~ prior to and/or during either the tli~x~to~y itself and/or delivery of bif~ f-;~l A co~trit~-tf~1 disc space is ~enPr~1ly on the order of 3 to 4 mm in the fli~t~nfx between v~ plates.
Suitable ~i~tr~ctiorl means are capable of providing on the order of about 3 atmospheres to about 4 atmospheres, (or on the order of ahlout 40 psi to about 60 psi) in order to distract that space to on the order of 8 to 12 mm between the vertebral plates.
Di~tr~rtif~n can be accompli~hf~ by any suitable means, inr,lutlin~ by mPrh~nir~l andfor hyd~ ic means. MPrh~nir~l means can incl~<le, for in~t~nce, ~tt~r.hing hooks or jacks to the bony endplates and using those hooks or jacks to separate the bones. Optionally, the ~ul~;eon can employ eYtern~l t~çtio~, however, with the patient on their side, eYtPrn~l traction will likely not be ~L~r~
Optionally, and ~l~reldbly, the space is ~ d by the use of one or more s-lit~hle insertable devices, e.g., in the form of inll~L~ble balloons. When infl~tP~l, such balloons provide rigid walls (e.g., fiber :iup~l~d) that are sllffif~iP.ntly strong to distract the space. An inflatable device provides s~-ffi~ient ~tlen~ and ~limPn~ion.~ can be prepared using convPntion~l m~tPri~l~ In use, theninfl~tPA balloon can be delivered to the center of the annular shell, and there;~n~l~ed to e~cpand the annular shell and in turn, distract the space.
The infl~t~hle device can be delivered to the disc space by any suitable means, e.g., in defl~tP~l form retained within or upon the end of a rigid or semi-rigid rod. Once positioned within the disc, generally centrally within the annular shell, a suitable gas ~e.g., nitrogen or carbon dioxide) can be delivered through the rod in order to inflate the balloon in situ, in a ~ n~ ly radial direction.
The fact that the balloon is properly placed can be confirmP~ by the use of W O 97/26847 PCTnUS97/00457 ancillary means, such as cine using a C arm, or by self-eff~ting means embodied within the balloon itself or its delivery a~ C
Suitable materials for p~ ing balloons of the present invention are those S that are plcse.. tly used for such ~ul~30ses as balloon angioplasty. Suitable m~tPri~lc provide an optimal coll.bination of such ~r~ Lies as compliance, biostability and biocoll,patability, and ".~h~llir~l char~ct~-ri~tics such as el~cti~ity and strength. Balloons can be provided in any suitable form, in~ ing those having a plurality of layers and those having a plurality of co"~ l-ents when exr~nde~l A useful balloon a~al~llus will include the balloon itself, togeLl-el with a delivery c~thet~r (optionally having a plurality of lumen eYtP.n~ing longitu~lin~lly LL. r~willl), and fluid or gas ~res.,ulc; means.
FY;~...ples of suita~le m~teri~l~ (e.g., resins) for making baUoons in~ de, but are not limited to, polyolefin copolymers, polyethylene, polycarbonate, and polyethylene terephth~l~t~ Such polymeric m~tt~ri~l~ can be used in either ullsu~ d form, or in ~u~olLed form, e.g., by the il~ ion of dacron or o~her fi~ers.
Balloons can also take several forms, d~n~linp on the manner in which the bio, ~le. i~l is to be delivered and cured. A single, thin walled balloon can be used, for in~t~nre, to contact and form a barrier along the interior surface of the annular m~t~.ri~l. Once positil~n~1, one or more curable bio...~t~ ;~ls can be delivered and cured within the balloon t~ serve as a repl~ ent for ~e removed m~t~ l In such an embo-limPnt the balloon is pr~r~l~bly of a type that will allow it to remain in position, without undue detrim~nt~l effect, belweell the annular m~tPri~l and the cured bio",~
Optionally, a balloon can be provided that fills less ~an the entire volume of the annular shell. In such an embo limlo-nt the balloon can be, for in.~t~nr,e, in the sha~?e of a cylinder. Such a balloon can be provided such that its ends can be po~ition~rl to contact the opposing vertebral bodies, and its walls will providesllffiçient strength to cause distraction of the space upon infl~ti~n, WO 97~6847 PCTrUS97100457 The~rlel, a first bio~ r,;~l is delivered to perimf~tpr of the annular space, i.e., the space be~ween the annular m~tPri~l and the balloon, and there cured. The biom~tpri~1 is delivered using suitable means, and under conflition~
suitable to ensure that it will not extrude through tears in the ~nm~
Optionally, the balloon can be p~r7~ 11y defl~tPcl as ~ 1ition~1 biCj."~tf ~ ;~1 iS
inserted into the space.
With the outer bio~ P ;~1 cured in place, the balloon can be removed and an additional biom~tP-ri~l, of either the same or a dirrt;n,lll type, can be deli~ d and cured in whatever re",~ g space was previously occupied by the balloon. A
second r~nmll~ can be used to deliver a second bio.~ l, pref~ldl)ly one that cures to provide a more fl~Yih1e region that more closely a~ i",~t- s the physical Gh~r~t~ri~ff--s of the origin~l nlleleus This method provides the option to lcconslluct the disc in a manner that more closely a~r~x;l~tes the overall physical r~ tr ;~tics and relationship of the crigin~l ~nn~ s and nU~ m:
A two step approach, as described above, is ~l~r~lled for a number of reasons. It provides the means for distracting the joint, while at the same time~- itit~ting the ~ aldtion of a final reconstructRd ~nnu~ having two or more regions. The dirreLel-t regions, i.e., a rigid outer shell in combination with a more liquid interior, can provide a function that mimics that of the native disc. In 2() addition to a two step approach, however, an impl~nt having a plurality of regions, ean be provided by other means as well. For inst~nr~, such an imp1~nt can be provided by the delivery of a s;ngle bio ~t~ 1 that is cured to a greater or ~liri'r~ g extent in its outermost, as co,.l~al~d to innermost, regions. An implant having a plurality of regions, or even a co~ llll of plop~Lies, is particularly 2~ ~rC~ Gd.
In an optional and pl~Çell~d emborlim~nt as descrihe~l above, a balloon can be inserted in nninllzlt~l form by means of a delivery f~thPter, e.g., in the form of a shaft, into the disc space. The balloon can be properly position~l in the discspace, e.g., within the annular shell following ~ ceclo-~~y~ and infl~t~l upon 3Q filling with biom~t~ri~1 in order to expand the balloon and thereby distract the space. In such an embodiment, the balloon can be inserted into the space, e.g., in 11ninfl~te~ or partially infl~t~l form, and filled in whole or in part with bio...At~ ;A1 under suffic~ nt con~1itiorl~, in~]u-ling ~7~ U1C~ to distract the space.
Con~ lenlly, the biom~t~-ri~l can be fully cured in the course of filling the balloon, in order to be retained ~ 1y in posi~on within the balloon and the ~ictr~cted space.
A ~ r.~led balloon configuration incl~des an 1minfl~ted balloon ~tt~-~hecl to a shaft, both of which are optffonally provided in a iniffal form covered by a removable sleeve portion, the assembled device being useful as an applicator to deliver the b~lloon in llninfl~t~d form to the disc space. A suitable balloon ~tt~-hmf~nt site is provided in the forrn of an inte~r~1 balloon stem portion, which can be retained in sealed but severable contact with the distal end of the shaftA suitable sleeve portion is provided in the form of co~ 1, telescoping sleeve having both a nall.,wed region ~limen~iQned to cover the shaft itself, and an e~r~nded region capable of Lcl~ining the balloon in a rolled or folded configuration in the course of delivering the baUoon to the site. Th~l~,l, as the sleeve is removed, the eYp~nded pocket is pulled back to release the balloon in situ. The sleeve can be fat~ricated from suitable m~tori~l~ and using techniqueswithin the skill of those in the art, given the present des~ Lion. Optionally, any portion, region or surface of the sleeve, shaft or balloon can be treated with friction rel~1cin~ co~t;~gs or other m~t~.ri~l.c to i,npf~,ve or otherwise alter the lubricity or other physical or ch~mi~ Lies.
A balloon of the present invention can be inflatably ~ f hed (e.g., provided in an releasable and u~ .n~1~A configuration) within or upon the end of a delivery shaft, in order to be inserted into the disc space. Pre~erably, the shaft and balloon are of sl-ffi~ nt flimen~inns and L)-o~Les to permit the balloon to be inserted using minim~lly invasive means, inc1ullin~ fiberoptic vi~n~1i7~tion-The shaft is preferably provided in the form of an elc)ng~tpcl tube having a distal end capable of being inserted to the disc space by minim~lly invasive means, and a pl'UAilllal end providing an ~ts~chmpnt site for a source of bioll.alefial. The CA 02244l97 l998-07-22 WO 97/26847 PCTrUS97/00457 shaft is s--ffi~i~ntly stiff and flexible to permit it to be inserted into a tissue access site of on the order of 4 cm or less, and preferably on the order of 2 cm or less, and moved through the body to access the disc site, while also having sl~fflc~ nt ~limfn~ions and surface properties to permit the flow of a desired bio;"~ l intoS the ~tt~hP~l balloon.
Once in place within the disc space, the balloon can be finally position~d within the space and filled with biom~ter~ flowing through the shaft, and under suM~ nt plC;S:~UlG to distract the space. In a ~rGrc;lred emb~imPnt, the balloon is "self-venting", in that whatever volume of gas may be present within the balloonlQ and shaft at the time of insertion can be ~ pl~cecl by the bio.. ~lf -;~l and vented through the balloon walls, e.g., to the ~ull~u~lding tissue. Optionally, or additionally, the shaft and/or balloon can be ev~n~tP~cl by the applic~tion of suction or vacuum to the shaft.
r~f~l~bly, some or all of the gas (e.g., air) present within the shaft and/or balloon is vented l~Lrougll the balloon m~te~i~l by virtue, and in the course, of the delivery of bio~ f ~i~1. As the bio.~ P- ;~1 fills the balloon, and ~ rl~$ the gas, the biomaterial also serves to inflate the balloon to a desired extent, and in asuitable position to distract the disc space. Once the disc space has been s -ffieient~y ~ t~t~te~1, the biomaterial can be cured, or ~l.lliUed to fully cure, in 2Q si~u in order to retain the balloon and biom~tPri~l pe",-~ .n~ly in place.
A ~lc;Ç~l~d fli~tr~-~tion device of this type compri~es an insertable, .J~ .n~l~ balloon formed of a self-venting, bioccslllpaLible m~tPri~l capable ofe~ a biom~teri~l in the course of joint distraction. Such a device, for in~nce, is capable of distracting a joint space by providing up to about 5 atmospheres or more ~ t~ction pSeS~Ule~ and preferably up to about 10 mos~heres or more. Preferably, the balloon itself is capable of wi~ ing y greater pl~s:;ure than that required to distract the space, e.g., up to about 10 atmo~ eles and preferably up to about 15 atmospheres or more.
Ln a particularly pl~cf~l~ed embodiment, the balloon is fabricated from natur~l or synthetic m~t~ , induding but not limited to, polymeric m~tPri~
W O 97126847 PCT~US97/00457 suc~ as films or membranes, and woven or nonwoven fabrics or m~-ch~s~ having ies s~lffiçi~nt to permit gasses to be vented th~ough the m~t.o.ri~1 in situ in the course of delivering the biom~t~.ri~1 Ihe balloon can be fabricated as one or more layers comI-ri~ing such m~tt~.ri~l~, and/or with one or more regions or portions of differing ~lu~.lies.
Those skilled in the ~lh~cnl art, given the present te~hin~, will ~plc ;aL~ the lll~U~l in which ~lGrGllGd balloons, inc1u-iin~ the m~t~.ri~ used ~o fabricate b~lloon~, will provide an optimal combination of such ~r~llies as bioco.l.~aL~bility, biodurability, strength, wall thi~kn~ss" wett~hility with a bio.,.~ 1, gas permeability (e.g., gas venting ability), puncture rç~i~t~n~ e, comp1i~nce, flexibility, modulus of P1~ticity, stress/strain curve yield point, burst UlC, m~ximllm inflation, and the ability to be easily f~hric~ted and sterili7~d.Examples of suitable balloon m~teri~ in~ , but are not limited to, solid . polymeric m~tPri~1~ such as me...bl~nes. Such polymeric m~tt~.ri~ can be provided with suitable venting holes, e.g., produced by the use of ~ ~c~ laser.
r~rt;rr~ m~teri~1~ include fabrics and meshes that are ~l.,rt;l~bly also wettable by the bio..,~ 1 of choice, in order to allow the bi~ 1 to seep rough the mesh as it cures, and to bond with and/or around the threads of the mesh in order to form an integr~1 structure with the mesh. In a plcser~lly ~crelr~d emboflim~nt the res1l1tin~ surface of the filled, cured balloon is g~n.o.r~lly uniform, having portions of the fabric scrim exposed. Optionally, the m~t~.ri~1 used to fabricate the balloon can itself be provided (e.g., illlpl~~ ~ or coated) with s~lit~hle mo~ifiers capable of affecting the rate andlor degree of bio...At~.. ;A1 cure. The use of a suitable catalyst, for ;..~ nce, can serve to cure the bio~ -';
more quickly upon contact with the m~tP.ri~l, thereby providing an outermost region having different çhPmic~1 p vl)ellies in the fully cured implant.
Suitable polymeric mAt~-.riA1.~ include tol~tompric and other m~t~ri~l~
commonly used for angioplasty _nd related applications, and include polyuletl.; ..es, polyolefins, poly~mides, polyvinyl ch1Ori~les, and polyethylene W O 97J26847 PCTrUS97/00457 l~lc~ tps~ as well as various copolymers, combinations and pG~ ;C)nC
thereof.
P~cr~llcd balloon m~tPri~l~ are available commercially for use in filtration and other applications, and include clothes and meshes formed of polymeric S m~tPri~lc such as polyester, polyl,r~ lene and nylon threads. Optionally, a m~fPri~l can be reinforced, e.g., with woven glass or fine fibers of other m~tPri~1~, to provided added strength or other desirable plo~ellies. Such m~t~ri~l~
are sel~tpcl to provide an optimal combination of such pl~ ies as strength, mesh opening, thread ~ mPter, mesh count, percent open area, and cost.
Suitable m~tPri~l.c, for in~t~nce, provide a mesh opening of between about 1 and about 100 microns and preferably beLween about l and about 10 microns.
Suitable m~t~ri~l~ further provide a thread ~ mptp~r of between about 20 micronsand about 50 microns, and a percelll open area of between about 1% and about 5%. E~a~.lplcs of particularly ~GÇellcd m~tPrt~l~ are commercially available andin~ de, but are not limited to, nylon screen cloth, such as a nylon mesh available as Part No E-CMN-5 ~5 m-icron mesh opening) from Small Parts, Inc. Miami Lakes, Fl, and from Tetko Inc.
Suitable m~tPri~1~ for fabricating the shaft portion of a ~ tr~l tinn device include polymeric m~tPri~ls that are preferably ~~hemic~tly cc,-l,palible with the balloon ~in order to f~cilit~tP attachment of the two), sllffici~Pntly strong (to will.C~ the bio,..~ l delivery ~ S:iUlG), and snffici~ontly flexible and inert in order to f?~ilit~t~P their use in vivo while positioning the balloon. A shaft can be of any desired t1imPn~ion~, e.g., on the order of S to 10 cm in height, 2 to 5 mm, and preferably 3 to 4 mm ~YtPrn~l rli~metPr, and lmm to 4mm, and preferably 2mm to 3 mm inner ~ mpt~pr~ with wall thicknPs~ of on the order of 0.3 mm to 1 mm.
The balloons thPm~Plves can be fabricatPd by a variety of means. In one ~i~fe~n d Pmho-1imPnt the balloon is formed as a continuous (e.g., unitary) and non~ G~ ~d (e.g., se~mles~) form, and optionally, as an intPgt~l part of the dis~al end of the delivery shaft. A membrane m~tPri~l can be formed, for CA 02244l97 l998-07-22 W O 97/26847 PCTrUS97/004~7 in~nee, by poeitic nin~ it over a suitably shaped mandrel under suitable conditions of time and lelll~ldlulG in order to cause the membrane to po. .,.~nPntly conrG~"~
to the shape of the mandrel.
In a,loLl,e~ fGllGd embo~lim~nt, the balloon is fabricated from a plurality of g~nPr~lly sheet-like portions, which can be assembled and sealed ~c-ge~
Sealing can be accompli~h~ by any suitable means, ;nçl~ in by the use of adhesives, sewing, RF bonding, heat sealing, impulse sealing, and any comhin~tior~ thereof. A particularly pr~r~ied seal is provided by RF bondlng following by a bead of a co..~alible adhesive capable of ~lulaling the bond.
Once sealed, the balloon is ~lGrGl~ly turned inside out in order to provide the sealed seam on the interior of the re~lllt~nt balloon.
The balloon can be fabricated to assume any desired shape upon infl~tinn, and in a yl~rel~d embodiment is provided in a generally ovoid shape, and preferably in the a~ shape of a kidney bean, in order to ap~n,,~;m~tP the l~i natural anatomical shape of the disc space itself. Preferably, the balloon provides two major s~ s for cont~rting ~ e velL~ldl end plates ~acing the disc space. The balloon further provides wall portions for contact with the annular shell within the disc space.
The ~1im~n~inne of the balloon will typically vary according to their intPn~e~ use. For use in the lumbar region of an adult male, for inet~n-e, the infl~t~l b~llc~n will typically have a lateral ~lim~on~ion of b~w~n about 20 mm and about 40 mm, and preferably between about 25 mm and about 35 mm, as well as an al~t~,ior/~o~ r ~limPneion of between about 15 mm and about 25 mm, and will inflate to between about 10 mm and about 15 mm in height for use in distracting the space. For the cervical region and thoracic region these llimPn~ione will be a~ v~ ly one-half, and three-fourths, respectively of the lumbar ~limPn~ionS.
When provided as a separate component ~ hPA to a delivery shaft, the bal~oon will preferably also include an integral stem or cuff portion or a region WO 97126847 PCTrUS97/00457 having a reduced ~ metPr (e.g., on the order of S mm to lQ mm) for use in ~chin~ the balloon to the distal end of the shaft.
A s--it~hlP mP~h~nic~l ~tt~rhmPnt for sP~llrin~ the balloon to the shaft involves tightly Wld~il~g the end of the balloon with a fine thread or suture toprovide a seal between the balloon and shaft. The balloon can be ~tt~rhP~l othermeans as well, e.g., by gluing, ~ttaehing, or intPgr~lly forming the balloon and/or a stem ~tt~chçd to the balloon to the cannula end. Optionally, the balloon is z~tt~che~ to the shaft by means of an integral stem, which preferably provides aregion that eYtPnds from the shaft and is lm~p~lp~d~ in order to provide a useful site for s~p~dlil~g ~e.g., cutting) the balloon from the shaft.
Preferably the ~ tr~rtinn device (e.g., either the balloon and/or the shaft portion) is provided with one or more oriPnt~tic)n ,llalh~,~, in order to permit the ~uly,eon to determine the optimal orient~tion of the balloon in situ. Suitable ori~-nt~tion .I-alh~ inrl~lde, but are not limited to, the pl lcempnt of clete~t~ble Ol in~lir~tions within or upon the balloon m~fPri~l and/or c~th~Pter, the m~rking~ or inrlic~ffnns thPm~e1ves being ~iP,tect~hle by minim~lly invasive means, e.g., by fiberoptic vi~ li7~tion, i~ltelopeld~ive m~gnPtir r~son~-ce im~ing ~, ultrasound, and laser radiation. The position of the shaft ~tt~rhmPnt to the balloon can itself be dçcignP~1 so as to permit the surgeon to properly place the balloon in the desired location in the course of surgery.
The llninfl~t~ balloon is ~lert;ldl)ly pO~itif necl within the annular shell, f~llowing (li~c-p~lnl~ly~ As described above, merh~ni~l distraction of the spacecan be used as well, e.g., either while inserting and/or positi~ ning the balloon andfor during inflation of the balloon with bio,n~f ;~1 A suitable ml~h~nir~l tl;str~rtinn device for this purpose includes the use of a plurality of pins (e.g., screws~ that can be placed in the opposing vertebrae and gra~ with a matable in~llulllen~, e.g., having a scissors-like grip and move,llel,l.
Once in place within the disc the balloon can be filled by having the shaft 3~1 connect~ to a bio~ te, ;~l delivery device capable of del;vering biom~trri~l W Og7126847 PCT~US97100457 through the shaft and into the balloon under snfflci~nt ~lGSi,ul~, optionally with mPrh~nic~ tr~rtion, to expand the balloon and distract the space. When in the form of a two-part curable polyulell.alle as described herein, the bio.n~ 1 willbegin to cure as it leaves the mixing çh~mher of the delivery device. It will con*n--e to cure as it plvgl~ses through the shaft and into the balloon. Ideally, the cure rate of the biopolymer is controlled, in co~ lation with the flim~n~ionc and other con~litions of the ~ tr~ction device, in order to provide s~-fflci~nt time for the bio."~ 1 to expand the balloon before final curing occurs. The distraction plogress can be monilolGd, e.g., by C arm cine or in~c..,~L~ti~e MRI.
Finally, the shaft can be removed from the inserted, infl~t~d and cured balloon~bio."~ l combination by any suitable means, e.g., by cutting the stem of the balloon using surgical means, or by heating a wire that has been previously ernhe~l~ in or around the circumference of the balloon stem.
Riomateri?~ls N~tural cartilage is a non-vascular ~llucLuf~ found in various parts of the body. Articular cartilage tends to exist as a finely gr~n~ r matrix fc-rming a thin in~...~ , on the ~. r~c~s of joints. The natural e1~tici~y of articular cartilage enables it to break the force of concuq~ion~, while its smoothness affords ease and freedom of movement. Preferred b~ r~re, are int.on~1~d to mimic many of the physical-chemical char~ tpri~tics of natural cartilage. Bio.~,~t~
can be provided as one component systems, or as two or more COIIIPOneJ~ S
that can be mixed prior to or during delivery, or at the site of rep~ur. ~Pner~lly such bio,--~t~ are flowable in their uncured form, m~ning they are of sllfficienf ViSCQSity to aUow their delivery through a c~nn~ of on the order of about 2 mm to about 6 mm inner ~ meter~ and ~lc;Çel~bly of about 3 mm to about 5 mm inner ~ mPtPr. Such bio",~t~ are also curable, mP~ning that they can be cured or otherwise mt clifi~7 in situ, at the tissue site, in order to undergo a phase or chPn-ic~l change sllfficient to retain a desired position and configuration.
When cured, ~ler~led m~t~ri~l~ can be homogc -eous ~i.e., providing the same chPmic~l-physical p~r~mptprs throughout), or they can be hel~logeneous. An W O 97126847 PCTrUS97/004S7 eY~mp1e of a heterogeneous biom~t~.ri~l for use as a disc repl~r~m~nt is a biom~tt~ri~l that mimics the natural disc by providing a more rigid outer envelope (akin to the annulus) and an more liquid interior core (akin to the nuclel~). In an re emb~iim~nt~ bio.-~ can be used that provide impl~nt~ having varying regions of varying or different physical-chemiç~1 p,~ ies. With disc repl~r~m~nt, for inst~nre, bio~ r~ i~ls can be used to provide a more rigid, annulus-like outer region, and a more fluid, nurleJI~-like core. Such di-or higher phasic cured m~t~isils can be ~l~al~d by the use of a single bio...~ l, e.g., one that undergoes varying states of cure, or a plurality of bio...~
Common polymeric m~tlori~l~ for use in mf~Air.~l devices include, for e-~mple, polyvinyl chlorides, polyethylenes, styrenic resins, poly~lu~ylene, thermoplastic polyesters, thermoplastic el~tc-m~rs, polyc~ul,onatGs, acryl- nitril~-but~ n~o--styrene ("ABS") resins, acrylics, polyulG~Ianes~ nylons, styrene acryloni~ s, and cellulosics. See, for example, "Guide to M~li~l Plastics", pages 41-78 in Medical Device & Di~nostic Industry, April, 1994, the ~ losl~re of which is incc"~ol~led herein by reference.
Suitable biom~t~-.ri~ls for use in the present invention are those polymeric m~t~ri~l~ that provide an optimal combination of ~lu~lhes relating to their m~nllf~tllre, applic~tion~ and in vivo use. In ~e uncured state, such p~ol~Gllies include processability, and the ability to be stably st~.ri1i7~d and stored. In the course of applying such m~t~ri~t, such ~,u~llies as flowability, moldability, and in vivo curability. In the cured state, such pl~c;llies include cured strength (e.g., tensile and co~ essive), stiffn~e~ biocompatability and biostability. FY~mples of suitable bio~ include, but are not limited to, polyulcll~e polymers.
In a plt;rell~ emborlim~nt, the biom~tPri~l comprises a polyu~ c polymer. Poly~ n~s, e.g, thermoplastic polyur~ es (" l~U"), are typically cd using three re~r-t~nt~ an isocyanate, a long-chain macrodiol, and a short-chain diol eYt~n~er. The isocyanate and long-chain diol form a "soft" segm~nt, while the isocyanate and short-chain diol form a "hard" segm~.nt The hard segmPnt~ form ordered domains held together by hydrogen bonding. These W O 97126847 PCTrUS97/00457 domains act as cross-links to the linear chains, making the m~tpri~l similar to a cross-linked rubber. It is the int.~ tinn of soft and hard segmPnt~ that determin~s and provides the polymer with rubber-like p.~ lies.
S Those skilled in the art, in view of the present invention, will a~.~;a~
the ~ L in which the choice of isocyanate, macrodiol, and chain eYten-ler can be varied to achieve a wide array of pl~c;l~ies. ~l~r~ d TPU's for mPAtr~l use are presently based on the use of a diisocyanate such as diphenylmP-th~nP
diiso~y~,dle ("MDI"), a glycol such as polytetr~m~thylene ether glycol, and a diol such as 1,4-bllt~nP~
In an further pl~f~llcd emb~limPnt the bio.~ 1 compri~es a thermosPfflng polyureLll~le polymer based on a suitable cc~lllbil-dLion of iso~;yd,~aLes, long chain polyols and short chain (low mo1o~c~ r weight) eYten~Pr~
and/or cro~link~-rs Suitable col..~onents are commercially available and are each ~lc;rt;ld~ly used in the highest possible grade, e.g., reagent or pf~r~bly analytical grade or higher. ~Yamples of suitable iso~;y;~lales include 4,4'-diphenyl mPth~nP
siiiso~y~ale ("MDI"), and 4,2'-diphenylmPth~ne diiso~;y~ulLe, in~ ling ~ Lu~
thereof, as well as toluene diiso~;y~.dle ("TDI"). FY~mrl~s of suitable long chain polyols include tetrahydl~ru-~l polymers such as poly(tptr~mpthylene oYide) ( PI~MO"~. Particularly p~efe--~d are combin~tion~ of PrMO's having mol~ r weigh~s of 250 and 1000, in ratios of between about 1 to 1 and about 1 to 3 parts, r~ecLively. FY~mrl~s of suitable eytp-n~p~rs/cro~ nkp-r~ include 1,4-bl-t~n~lioland trimethylol p~ c, and blends thereof, preferably used at a ratio of 1)~
about 1 to 1 and about 1 to 7 parts, respectively.
P~i~""~ of the present invention can also include other optional adjuvants and additives, such as stabilizers, fillers, antioxidants, catalysts, pl~tici7Prs, pi~m~nt~, and lubricants, to the extent such optional ingredients do not ~limini~h the utility of the co..l~o~iLion for its intenflP~ purpose.
When cured, the bio.~ demon~ t~ an optimal combmation of physi~ chPmic~l properties, particularly in terms of their confo,~ Lional stability, -WO 97~26847 PCT~US97/00457 ollltion stability, bioco,..pa~bility, and physical ~e.ro~ ce, e.g., physical prop~.~ies such as density, thickness, and surface ro~ hne.~, and m-~hz-ni~1 ~ropellies such as load-be ring strength, tensile strength, shear strength, fatigue, impact absol~lion, wear cha~teri~tics, and surface abrasion. Such pe rol---allceS can be evaluated using procedures commonly accepted for the evaluation of natural tissue and joints, as well as the evaluation of biom~tPri~
In particular, p-ef~,llGd bio.~ e.;~1~, in the cured form, exhibit ~ .h~ni~
Lies that ~ xim~t~. those of the natural tissue that they are intontl~ to replace. For in~t~nce7 for load bearing applications, ~rert;.lGd cured composites e~hibit a load bearing strength of between about 50 and about 200 psi (pounds per square inch), and preferably between about lO0 and about 150 psi. Such composites also exhibit a shear stress of between about lO and lO0 psi, and preferably bG~weGn about 30 and 50 psi, as such units are typically del~-- ...in~d in the evaluation of natural tissue and joints.
Preferred biom~t~ri~1~ are also stable under con~lition~ used for ~,t~ri1i7~ticm, and additionally are stable on storage and in the course of delivery.
They are also capable of flowing through a delivery c~nm-1~ to an in vivo location, and being cured ~n situ, as by exposure to an energy source such as ultraviolet light or by çh~mi~~1 reaction. Th~learLer the cured biom~tp~ l is suitably ~mPn~le to shaping and eonlou,illg, by the use of conventional or custom ci~nPd alLlll~sco~ic tools or instruments. Over the course of their use in the body the cured, contoured biom~tPri~1 exhibits physical-c.ht-mic~1 plu~;lLes s1-it~h1e for use in extended in vivo applications.
In a plt;r~;lled embodiment, the bio...~ 1 is a polyun,ll,al e provided as a two-part prepolymer system comprising a hydr~,gellal~d MDI isocyanate, polyethylene~polypropylene oxide polyol, and l,4-b~1t~nPAio1 as a chain eYt~.n~ler.
The final polymer having a hard segment content of about 30 to about 40% by weight, based on the weight of the hard segmPnt Thixotropic agents, such as thatavailable under the tr~-lPn~me "Cab-o-sil TS-720" from Cabot can be, and W O 97126847 PCT~US97/00457 preferably are, usPA to achieve the desired flow and pre-cure viscosity characteristics .
Optionally, and preferably, one or more catalysts are incorporated into one or more co~ onents of the biomaterial, in order to cure the biom~tPri~l in the S physiological environment within a desired length of time. Plert;~dWy, hio,..~ lc of the present invention are able to cure (i.e., to th-e point where distraction means can be removed and/or other bio,~ 1 added~, within on the order of S minlltes or less, and more preferably within on the order of 3 I.l.n~lt'S
or less.
~Lef~ldbly, means are employed to improve the biost~hility, i.e., the oxidative andJor hydrolytic stability, of the bio..,~ei;~l in vivo, thereby PYtçn~lin~
the life of the imp1~nt See, for in~t~nce, A. Tz~k~h:lr~l, et al., "Effect of Soft .Segm~nt l~hPmi~try on the Biostability of S~mPnt~P~ Polyul~ nPs. I. In vitro Oxidation", J. Biompslic~l Materials Research, ~E:341-356 (1991) and A.
Tslk~h5~r:l~ et al., "Effect of Soft Segment Chemistry on the Biostability of Sç~mPnt~d Polyulc~ Ps. II. In vitro Hydrolytic DeF~ hcn and Lipid Sorption~, J. Bion eAi<~ teri~1s Research, 26:801-818 (1992), the ~ closllres of both of which are incolL,oldted herein by reference.
Suitable means for improving biostability include the use of an ~liph~hr~
macrodiol such as hydrogens~tçd polybu~iene (HPDI). By judicious choice of the culr~onding diiso~;y~la~ (e.g., MDI) and chain eYtP-nflçr (e.g., ethyl~nP~ minP), those skilled in the art will be able to achieve the desired p~king density, or crystallinity, of the hard s~..,~ , thereby improving t~e hydrolytic stabili~y of the cured polyul~ e.
Biom~t~Pri~l~ provided as a plurality of co~ onents, e.g., a two-part polyure~ e system, can be mixed at the time of use using suitable mixing techniques, such as those commonly used for the delivery of two-part adhesive formulations. A suitable mixing device involves, for in~t~nce, a static mixer having a hollow tube having a segmçnted, helical vein lunl~iilg through its lumen.
-W O 97/26847 PCTrUS97/00457 A two-part polyurelll~le system can be mixed by forcing the lG~ecLi~re C~"'~ on~Qnt~ through the lumen, under pn s~..l~.
In a further embo limPnt the static mixer can be used in a system having an appli~tic~n ç~nmll~, an aprlic~tion tip, and a cartridge having two or more S cl~."k~- ~, each co~ inil-g a s~aldle ColllpollGIlt of the biom~tPri~l system. A
hand-powered or çl~trie~lly controlled extrusion gun can 'oe used to extrude theco.-,~~nents through the static mixer, in order to completely mix them and thereby begin the process of curing. The biom~tPri~l system then flows through the ~nmll~ and to the joint site or surface through the application tip. The length,~i~metPr, and vein design of the mixing el~mPnt can be varied as n~e~ r to achieve the desired mixing efflciPncy.
F~y~m~ ç
In pGlro~ g a ~rGfGllGd method of the present invention, the patient is brought to the pre-surgical arça and prepped. ~nPsthP~i~ is then in-~uced and the area of the spine is further prepped. A small inci~inn ~ong the p~inal mll~lP~
is opened under ~ c*ng microscopic vi~ li7~ticn The incision typically ranges betweçn 3 and 6 cPntimPt~rs in length and is longit~ in~l in the plane of the spine.
The paraverte50~al muscles are s~?aldted by blunt ~ ctinn and held apart with forceps and dividers. The intervertebral disc area is vi~u~1i7PA, with initial exposure down to the lamina. The ared below the l~min~, at the point of the intervertebral foramina, can also be exposed.
The disc is PY~min~d for extruded m~teri~l and any extruded m~tPri~l is removed. Mzl~nPti~ ce im~ging ("MRI") data can be used to ~le~ - ...il-~- the i~ltegliLy oiF the ~nm~ fibrosis at this point. An a,~ oscope is inserted into the disc and used to eY~minP the inside of the ~nnn1lls. Optionally, an intra~)pc.dLivc;
~i~g, ~ can be ~elrc,ll--ed, in which a dye m~tPri~1 is inserted and vi~n~li7~d in order to ~.lb~L; ,-~ the integrity of the ~nmlllls fibrosis. Points of we~kness, or ,. rents, in the ~nmlllls fibrosis are i(lentifi~1 and located and suitable means, e.g., a bin~l-so,bable glue is employed to block these rents.
Di~tr~tic)n of the in~clvclLPI)l~l disc space can then be accompli~h~, as rle scrihe~ above. Once under traction, a bio..~ l, e.g., biopolymer of the present invention is introduced to the distracted space. The polymer is preferably cured over 3 to 5 minutes, and preferably within 1 to 2 ~ lr.s The ~ll-~osccpic c~nn~ and the applic~tion ~~nnlll~ are removed. The m~tPri~l is further aUowe~
to harden over 15 to 20 ...i...ll~s and the disc traction is removed.
The desired quantity of the curable bio...~ l is delivered by minim~lly invasive means to the plc~alc;d site. Uncured bio...~ 1, either in ~uLt~ or in the form of sep~-,-lP reactive components, can be stored in suitable storage c~nt~inpr e.g., sterile, teflon-lined metal c~ni.~t~ors. The biom~tt~ri~l can be delivered, as with a pump, from a storage canister to the delivery c~nnlll~ on dem~n-~.
Biom~t~ri~l can be delivered in the form of a single co~ osiLion, or can be delivered in the form of a plurality of co~ onents or ingreAiPnt~ For in~t~nce, bic~ te.;71 co.~l~onel-t~ can be sep~Mt~ly stored and suitably mixed or combinedeither in the course of delivery or at the injury site itself.
In terms of its col,.pollellt parts, a plcfelled delivery system of the present invention will typically include a motor drive unit, with a remote controller, teA tube sets, a nonscope inflow delivery ~nmll~, having independent fluid dynamics ~ '7i:iUle and flow rate adj.l~l---~-~t~ hm~nts for the flush, vacuum, waste ç~ni~ter, and overflow jars.
The application c~nmll~ is inserted into the joint or disc space and under vi~ tit n from the fiberoptic scope the bio~ lr, ;~l is delivered. The flow of the biom~~ri~l is controlled by the operator via a foot pedal co~ ~;l~ to the JUll~pil~g m~rh~ni~m on the polymer canister. The biom~t~ri~l flows from t-h-e tip of the application catheter to fill the space provided.
The delivered bio...~ ;;.l is allowed to cure, or cured by minim~lly invasive means and in such a manner that the cured bio.~At~ 1 is retained in apposition to the ~ d site. As described herein, the bio..~ 1 can be cured by any suita~le means, either in a single step or in stages as it is delivered. Once CA 02244l97 l998-07-22 W O 97/26847 PCTrUS97/00457 cured, the bio...~t~ 1 surface can be contoured as needed by other suitable, e.g., endoscopic or ~ ~llvsco~ic,instrl-m~nt~ The joint is i~ig~t~d and the in~u,..e removed from the portals.
At that point, in~l~e~ e x-rays are obtained to ~ul~ te the preservation of the intervertebral disc space. Direct observation of the in~l~ l Çc..,~ for free cursing of the nerve rootlet is ~sl;."1;i.~ by vi~n~1i7~ti~n. The retr~ct~ m~ s are replaced and the local fascia is closed with inl~.lu~led absorbable suture. The sub~;ul~ ~us fascia and skin are then closed in the usual f~hion The wound is then dressed.
As mPntil~n~d above, the cured bio~ Al can be subjected to further physical~ch~mie~1 modifications, e.g., in order to ~nh~n~e it ~Lîo..~ ce, bioco---pa~ility, biostability, and the like. For instance, calcitonin and infl~ oly inhibiting molecules such as Tnte~le~1k~n I inhibitors can be ~tt~rhecl to the bone co~ osiLe surface to prevent local osteoporosis and local inn~
response which may cause loosening. Simil~r1y, the surface of the cured bic,...;~ 1 can optionally be modified in order to alter, e.g., reduce, its lubricity or coefficient of mctinn-Diarthroidal and A-1-~hia~ roidal Joints.
The method and bio...~ 1c of the present invention can be used for the repair of other tissues and joints as well, inc1l1-1ing, for in~t~nce, the glenoid surface of the shoulder, the first carpomet~l ~rpal joint of the hand, the knee, the l~ip, the hallux joint, the le---pol~l mandibular joint, the subtalar joint in the ankle, the other ~lle~l ph~1~n~eal ioints of the feet.
With respect to the shoulder, for in~t~nce, a common situation arises in the elderly patient who has a degenerated rotator cuff. Usually, such p~tient~ have lost the superior portion of the rotator cuff with the complete loss of the ~tt~ tendon. Often they also have a superior riding of the humerus so ~ that it art~ tP.s very high on the glenoid and with any abduction there is ~i~nifi~nt imrin~em~nt on the acromium process.
CA 02244l97 l998-07-22 W O 97126847 PCTrUS97/00457 Using the a~p-~,acl- pl~;senlly described, a biom~teri~l can be delivered, cured, and ~tt~hPd to the g1PnQj~, all using minim~lly invasive means, in order to resur~ace the glenoid surface and extend up over the superior portion of the humerus. There the cured biom~tPri~1 will act as a spacer between the humerus S and the aclo~liu~ process. I~es~ ing the underside of the acfv.,liu,., and the glenoid with a single structure that allows the humerus to be spaced down from the acrvll~iulll process and to avoid impingement on the ac~ lliul~ with a~duçtion-Other areas of the body that will also benefit from the creation of a spacer, yet do not involve ~ignif~ nt weight-bearing con.ctr~int.C, include the first carpom~a~rpal joint of the hand, the r~ h11mPr~1 joint. The method of the present invention can be used to provide a spacer that will allow motion with a minim~lm of friction, while also providing desired mech~nic~l stability to the area.
Yet other applications include repair of the first carpomet~ rpal joint, which is another dia,lhloidal joint. The carpal bone and the base at the ...e~ al are normally covered with articular cartilage. Ihis joint, however, is subject to ~ignific~nt degenerative change over time because of stresses that are placed on it by normal hand motion. Ihese stresses can result in a na.lowing of the joint space and eventually a bone-on-bone situation, with m~rk~d loss of motion and ~ignif~ nt Such a joint can be repaired by minim~11y invasive means using the method of the present invention, e.g., by placing an ~ iate spacer of bi~ r-li31 through the arthroscope and ~M~in~ it to one side or the other of the~oint.
In such a procedure, two small holes can be drilled into the base of the mPt~ rpal, for inst~nCe ~urable biom~ttori~1 can then be applied into those anchor points and over the surface of the base of the mPt~ rpal. The final curedbiom~t~ri~1 provides both a cushioning and a spacing function, which will serve to decrease p~in and improve motion and filnction Yet another joint that is amenable to repair using the present method is the hallux joint, also known as the metatarsal phalangeal joint. In a condition called hallux rigitlit-1s, the cartilage between the base of the 1st phalanx and the end of W O 97126847 PCT~US97100457 the first mPt~t~r.~1 has degenerated and there are ~ignifiç~nt bony spurs forming due to the degçn~dlil~n of the cartilage. As with the first c~u~o...~-~;.r~rpal joint at the wrist, the method of this invention can involve arthroscopically drilling a plurality of small holes in the head of the metatarsal and delivering and curing a bio",~ l to produce the needed cll~hioning and sr~in~.
Yet other areas of application include the rll,luc~lilage of the lelllPU~
mandibular joint, cGslocl ondral junctions, and the acromioclavicular joint.
Another application involves the subtalar joint in the ankle. This is a common area for medial subluxation of the anle in the patient with rhP~Im~toid arthritis who gets s~-Glchillg and w~kt-ning of the tibialis posterior tendon and instability at the medial aspect of the ankle, res--~ting in persistent anlde pain. A bio".~le. ;~l and m~thol1 of the present invention can be used to build up the subtalar joint area in order to realign the anlde and correct the eversion of the foot, thereby ol,~ialing the need for an ankle fusion.
Ihe for~going description is intPn-l~P~1 to be illustrative of the invention, but is not to be considered as cc,ll,~rehensive or timitin~ of its scope.
Claims (25)
1. A method for repairing a diarthroidal or amphiarthroidal joint, the method comprising the steps of:
a) using minimally invasive means to remove damaged or diseased fibrocartilage from the joint and to provide a mold capable of containing curable biomaterial in a desired position within the joint, b) providing one or more curable biomaterials to the mold, and c) curing the biomaterials within the mold in order to provide a replacement for the fibrocartilage.
a) using minimally invasive means to remove damaged or diseased fibrocartilage from the joint and to provide a mold capable of containing curable biomaterial in a desired position within the joint, b) providing one or more curable biomaterials to the mold, and c) curing the biomaterials within the mold in order to provide a replacement for the fibrocartilage.
2. A method according to claim 1 wherein the method is used to repair a diarthroidal joint in the form of an intervertebral disc.
3. A method according to claim 2 wherein the method comprises the steps of:
a) using microsurgical techniques to perform a discectomy while preserving an outer annular shell, b) providing one or more curable biomaterials to the interior of the annular shell, and c) curing the biomaterials in order to provide a replacement disc.
a) using microsurgical techniques to perform a discectomy while preserving an outer annular shell, b) providing one or more curable biomaterials to the interior of the annular shell, and c) curing the biomaterials in order to provide a replacement disc.
4. A method according to claim 3 wherein the disectomy comprises the step of distracting the disc space by means of inflatable distraction means.
5. A method according to claim 4 wherein the distraction means are provided in the form of an inflatable balloon.
6. A method according to claim 5 wherein the balloon is delivered in deflated form to the interior of the annulus and there inflated in order to distract the disc space and provide a mold for the delivery of biomaterial.
7. A method according to claim 6 wherein the balloon is formed of a polymer selected from the group consisting of supported and unsupported polyolefin copolymers, polyethylene, and polyethylene terephthalate.
8. A composition comprising a biomaterial capable of being delivered to the site of cartilage damage and there cured in order to provide a replacement for the cartilage.
9. A composition according to claim 8 wherein the biomaterial is provided in the form of a curable polyurethane.
10. A composition according to claim 8 wherein the polyurethane is capable of being mixed at the time of delivery in order to initiate its cure.
11. An apparatus for use in joint repair, the apparatus comprising an insertable, inflatable balloon being suitably dimensioned to be positioned within the intervertebral disc space of a human and there inflated in order to distract the disc space.
12. An apparatus according to claim 11 wherein the ballon is capable of being inflated with biomaterial in order to distract the disc space.
13. An apparatus according to claim 11 wherein the apparatus comprises rigid walls and is suitably dimensioned to be positioned within the intervertebral disc space of a human and there inflated in order to distract the disc space.
14. An apparatus according to claim 13 wherein the balloon is prepared of a material selected from the group consisting of supported and unsupported polyolefin copolymers, polyethylene, and polyethylene terephthalate.
15. A diarthroidal or amphiarthroidal joint having interposed therein a biomaterial that has been cured in situ.
16. A joint according to claim 15 wherein the biomaterial was formed by mixing a two-component polyurethane.
17. An apparatus according to claim 12 wherein the apparatus is provided in the form of an inflatable balloon inflatably attached to the distal end of a delivery shaft.
18. An apparatus according to claim 17 wherein the balloon is comprises a material that permits gasses to be vented from the balloon upon filling with biomaterial.
19. An apparatus according to claim 18 wherein the material comprises a nylon mesh.
20. An apparatus according to claim 17 wherein the balloon is severably attached to the shaft.
21. An apparatus according to claim 12 wherein the balloon is capable of being inflated with biomaterial to provide up to about 10 atmospheres distraction pressure.
22. A method according to claim 4 wherein the inflatable distraction means comprise an inflatable balloon attached to the distal end of a delivery shaft.
23. A method according to claim 22 wherein the balloon comprises a material that permits gasses to be vented from the balloon upon filling with biomaterial.
24. A method according to claim 23 wherein the material comprises a nylon mesh.
25. A joint according to claim 15 wherein the cured biomaterial is contained with an inflated balloon.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US08/590,293 US5888220A (en) | 1994-05-06 | 1996-01-23 | Articulating joint repair |
US08/590,293 | 1996-01-23 |
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Publication Number | Publication Date |
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CA2244197A1 true CA2244197A1 (en) | 1997-07-31 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002244197A Abandoned CA2244197A1 (en) | 1996-01-23 | 1997-01-17 | Articulating joint repair |
Country Status (8)
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US (1) | US5888220A (en) |
EP (2) | EP1570814A1 (en) |
JP (1) | JP3769022B2 (en) |
AT (1) | ATE293410T1 (en) |
AU (1) | AU1826497A (en) |
CA (1) | CA2244197A1 (en) |
DE (1) | DE69733062T2 (en) |
WO (1) | WO1997026847A1 (en) |
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-
1996
- 1996-01-23 US US08/590,293 patent/US5888220A/en not_active Expired - Lifetime
-
1997
- 1997-01-17 DE DE69733062T patent/DE69733062T2/en not_active Expired - Lifetime
- 1997-01-17 WO PCT/US1997/000457 patent/WO1997026847A1/en active IP Right Grant
- 1997-01-17 AT AT97903783T patent/ATE293410T1/en not_active IP Right Cessation
- 1997-01-17 EP EP05008503A patent/EP1570814A1/en not_active Withdrawn
- 1997-01-17 EP EP97903783A patent/EP0886506B1/en not_active Expired - Lifetime
- 1997-01-17 CA CA002244197A patent/CA2244197A1/en not_active Abandoned
- 1997-01-17 JP JP52689297A patent/JP3769022B2/en not_active Expired - Fee Related
- 1997-01-17 AU AU18264/97A patent/AU1826497A/en not_active Abandoned
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DE69733062D1 (en) | 2005-05-25 |
JP3769022B2 (en) | 2006-04-19 |
ATE293410T1 (en) | 2005-05-15 |
JP2001508317A (en) | 2001-06-26 |
EP1570814A1 (en) | 2005-09-07 |
EP0886506B1 (en) | 2005-04-20 |
AU1826497A (en) | 1997-08-20 |
US5888220A (en) | 1999-03-30 |
WO1997026847A1 (en) | 1997-07-31 |
EP0886506A1 (en) | 1998-12-30 |
DE69733062T2 (en) | 2006-03-02 |
EP0886506A4 (en) | 1999-11-17 |
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FZDE | Discontinued |