WO2010148112A1 - Expandable support device and method of use - Google Patents
Expandable support device and method of use Download PDFInfo
- Publication number
- WO2010148112A1 WO2010148112A1 PCT/US2010/038857 US2010038857W WO2010148112A1 WO 2010148112 A1 WO2010148112 A1 WO 2010148112A1 US 2010038857 W US2010038857 W US 2010038857W WO 2010148112 A1 WO2010148112 A1 WO 2010148112A1
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- WO
- WIPO (PCT)
- Prior art keywords
- load
- ice
- sliding
- expandable
- longitudinal
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
- A61F2/4465—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7097—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/885—Tools for expanding or compacting bones or discs or cavities therein
- A61B17/8852—Tools for expanding or compacting bones or discs or cavities therein capable of being assembled or enlarged, or changing shape, inside the bone or disc
- A61B17/8858—Tools for expanding or compacting bones or discs or cavities therein capable of being assembled or enlarged, or changing shape, inside the bone or disc laterally or radially expansible
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
- A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
- A61B17/1671—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the spine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
- A61F2002/3011—Cross-sections or two-dimensional shapes
- A61F2002/30112—Rounded shapes, e.g. with rounded corners
- A61F2002/30133—Rounded shapes, e.g. with rounded corners kidney-shaped or bean-shaped
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30579—Special structural features of bone or joint prostheses not otherwise provided for with mechanically expandable devices, e.g. fixation devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30593—Special structural features of bone or joint prostheses not otherwise provided for hollow
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
- A61F2002/30891—Plurality of protrusions
- A61F2002/30892—Plurality of protrusions parallel
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2002/448—Joints for the spine, e.g. vertebrae, spinal discs comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0004—Rounded shapes, e.g. with rounded corners
- A61F2230/0015—Kidney-shaped, e.g. bean-shaped
Definitions
- This invention relates to devices for providing support for biological tissue, for4 example to fuse vertebral bodies, repair herniated discs, and/or repair spinal compression 5 fractures, and methods of using the .same. 6 7 2. Description of Related An S ⁇ 0003
- Vertebroplasty is an image-guided, minimally invasive, nonsurgical therapy used4 to strengthen a broken vertebra that has been weakened by disease, such as osteoporosis5 or cancer. Vertebroplasty is often used to treat compression fractures, such as those6 caused by osteoporosis, cancer, or stress. 7
- 00051 VertebropJasty is often performed on patients too elderly or frail to tolerate open8 spinal surgery, or with bones too weak for surgical spinal repair. Patients with vertebral9 damage due to a malignant tumor may sometimes benefit from vertebroplasiy. The0 procedure can also be used in younger patients whose osteoporosis is caused by long-term 1 steroid treatment or a metabolic disorder.
- Vertebroplasty can increase the patient's functional abilities, allow a return to the3 previous level of activity, and prevent further vertebral collapse. Verlehroplasty attempts4 to also alieviaie the pain caused by a compression fracture.
- IH is also desued iv f ⁇ OJOj () ⁇ h « ailments of the spine iestiit m degeneiauon of she spinal disc iu the
- Consm atn e treatment can include treatment requiring 1 pauents to adjust their Wests lcs> and submit to pam reliefers and a ie ⁇ e! of underlying
- AUo desired is an intervertebral dexite the ma ⁇ he inserted m to the mlmertebral
- expandable suppoit dc ⁇ ice can ha ⁇ c a longittkimal axit. and a iadial a ⁇ is f he expandable 2 support ice can be conikiued to expand m a iadial duection, for example constrained 3 to expansion in a single dimension I he de ⁇ ice can expand perpendicalit to the
- longitudinal axis of the ice can top and or middle and or bottom 2"> components ⁇ he top a ⁇ d-or middle and oi bottom components can oi
- the deuce can expand tadialh (e g soleh in height or width ⁇ ( ) lonaitiidmalK Height expansion can octoi alone a vupeuor-mfe ⁇ oi
- the tJeute can have a locking pin
- the locking pm can be mterfeience fit with
- the 1 ktekniL' pin can into feieuce fit w ⁇ h the fust s ⁇ uL and'Oi w itti a longitudinal port of the
- the expandable support device can be configured to apply a
- 14 of the tool to apph a e foice may include squeezing two handle., together oi
- the expandable can be filled % s ⁇ h a material, such as a biocompatible
- w hen used to tieat compr «si>toa fractiu es, iv a nmie ⁇ al such bone cement, us ⁇ ue « bone gtowUi factois. bone morphogeny proteins,
- stem cells earners Sbi anx of the foregoing, or mixtures thereof can be insetted v ⁇ tthm the
- the giowth factois and stem cells used can be 8 those commercially aifc ⁇ ie and oi can be exti acted Aom the patient's blood oi ( ) bone raarraw aspirate 0 J0021]
- the rauo of the expansion tot the expandable ⁇ the iatio of the 1 unexpaiided height or diameter, depending on configuration, to the expanded height oi 2 diameter) ma> be from I 2 to 1 5 or greater i-or iniraxertebml and imene ⁇ ebial 3 ⁇ ppiicauons the dev ice expansion tatios of ftom about I 3 to about 1 4 Tm can hax e an initial height or diameter 1 fi ⁇ in about 4 ram (0 16 m ) to about 8 mm (03 i
- Figut e 2b is a sanation oi cross-section B-B ot Fsg ⁇ e 2a.
- Figure 3a illustrates a ⁇ anauori of the device in a height-expanded configuration
- Figure 3b is a variation of cross-section C-C of Figure *a
- tiguie 4b is a top new of a ⁇ a ⁇ ation of the deuce in a heigk -expanded
- Figute 5b iUusttatcs a vauation of a method for using the dex ice mg a
- F tgurcs 6a and 6b are side pei spccuve and top perspectn e ⁇ tews, respcctn eiy or
- Figure 22 illustrates a ⁇ a ⁇ aU ⁇ n of a method fo ⁇ deploying the expandable support
- Figuie 23 illustrates va ⁇ aUons of methods for depSov ing the expandable suppon
- the 3 expandable support de ⁇ ice 2 can be used, lot example, for methods of repairing ⁇ crtcbral
- the expandable support 2"S 2 can a fit st longitudinal end a.id a second longitudinal end al ⁇ ng a
- the expandable support dc ⁇ ice 2 can base oi botiom (w and bottom 8 iuc used interthangeabh V a middle 6b, and a top component f>e
- the base or bottom fta ( ) and top 6c can be ot plates, panels sififc (e g . le ⁇ si porfc, ceils, and combmations
- the base 6a i ⁇ n ⁇ top 6c can he configured to be slidabh attachable to the middle
- the tup 6c can e one oi mote top slabilits hats St Fot example, the tup
- the base da can c one oi
- 6 can have two seK of one, two or more symmetntalh opposite, lateiail) located top ol tw o s> ⁇ mnwscaJ! ⁇ apposite,
- the base Oa can have one or more base stabthh bars Ha
- 11 8a can extend fiom the base in the chrecuon of the top 6c I he top 6c can ha ⁇ e one oi
- the top 6c can e U ⁇ o or more sets* of Iw o. three f as Ut sh(mn) or more wrnmct ⁇ caH ⁇ opposne ia eraih located top stabihtv grooves 10c, as 1 " * ihow n
- the shdable attachment ⁇ f the top H and base 6a can pei rou the base f>a to raov e iy iadialh ⁇ w tth jespect to the iongHudtual a Mb 4) telatt ⁇ e to Lhe top 6c and ⁇ ice ⁇ eisa
- telatt ⁇ e to Lhe top 6c and ⁇ ice ⁇ eisa
- the top 6c can extend superior!) away from the base 6a w hen the JCC 2 ts
- top Oc can ha ⁇ e a htgh-f ⁇ ctton te ⁇ tute and or a low -fnction surface extending 1 a ⁇ a ⁇ Aom the base 6a on the surface faemg avun ft om the base 6a tor example the top 24 he can ha ⁇ e one or numerous row s of top teeth 12c
- the bottom 6a can ha ⁇ c a high- fi ⁇ m the top be Foi example, the
- 26 boitorn can one oi numcioos ums of bottom teeth The top teeth !2c an&oi the
- the teeth 12 can be at tanged to hax c ndges parallel w ith the 8 iongjtudma] axis 4, w ith the iongitudtnal axis 4, at a non-zeio and no ⁇ -nght ( ) angle l ⁇ the longitudinal a ⁇ Ls 4. oi combmations thef e ⁇ f The top aiid-or bottom sui faces.
- he top 6c can b ⁇ e one or more side ports and or top poits 14c 1 he base 6a can V* one oi moie base potts 14a amJ'Oi side pons
- the ports 14 can be cneuUi squate 1 tnau ⁇ uiai ⁇ al elongated m ⁇ ic longituduud due ⁇ s ⁇ n. elrugated in the iadial direction.
- F he top 6c and or base 6a can ha ⁇ c atiaiimauc edges, such as chamfered
- the chainlets can euend along the pe ⁇ metei of the base 6a and or top 6c
- the expandable support device 2 can one, two, Uu ee or moie sets of
- Fhe lop 6c and or base 6a can ha ⁇ c a series of unidirectional and or bidrectional
- the top f>c can hav e a lop first ramp i 6c', a top second ramp 16c "
- the umdnecuonal iamps 10a and oi 1 f>c can be configured to
- ramp stop 1 H can be the face of the ramp that w closer to a petpendicuisr angle to the
- the middle Ob can a seues> of iii ⁇ h ⁇ ectional and or hidreciionai ramps, such
- umdiiccnonal ramps 16b can be configuicc" to a ramp stop IH at one longitudinal IH end ol ilie ianip 16b iv
- the lamps 16 can ha ⁇ e lamp leagues and correspond groo ⁇ es 20 on adjacent
- Ramp tongue and groo% Cs 20 on corresponding ramps 16 can be configured to
- top ramps 16c 2 can top tongues and grooves
- the middle ramps 10b can middle tongues and 3 grow es 20b that can slidabl> engage the top tongues and gioov es 4 [8MO]
- Fhe ramps 16 can ha ⁇ e ramp angles 22 with ictpcct to the longitudinal axis 4 "S I he ramp angle 22 can be fiom about 1 ⁇ ° to about 7i; > t ⁇ mote narrow K from about 20° to
- One or more of the lamps 16 can have ⁇ tamp stop 18
- the iamp slops Ih can be 8 configured to abut and mteifcrence fit against a cones ponding ramp stop i H on the ( ) adjacent element O e .
- ihe top 6c can be adjacent to the middle Ob i 0 J ⁇ 62] The base Oa ⁇ .
- OJ top 6c can ⁇ fftst side plate 24i, for example 1 at the distal longitudinal end of the base 6a 2
- I he base 6c can a base rail 26a
- Hie middle 6b can ha ⁇ e a middle rail 2(>b 3
- the middle rail 26b can be vhdabh fed owto or under the base rat! 26a
- the base tatl 2(>a 1 and the middle mi! 26b can coiisitaui motion bem ecn the middle 6b mid me ba.se
- the fust side port can a fiist side outer pou 28a on the first plate 24a
- the fust side port can bm e a Hi st side cents al pon 28c in the top 6c
- pon 2Sc can be open on the bottom, foi example to ailov the Ht st side cenUal p ⁇ it 2Sc to
- the middle 6b can ha ⁇ e a fust
- first side outer port 2Ha can form a recess in the first side plate 2Ha. for example to
- the base 6a can one oi inoie nunp seats JO, for example, the ramps seats 30
- the top lamps 16 can be positioned iat ⁇ aik s ⁇ mmeti it-ally on the top 6c
- 16 ramps 16c can be distributed along the length of the top 6c
- the ramp scats MJ can
- the top ramps i 6c can mterfeience fit agamM the ramp stops 18 of the middle ramps 16b 2 2 can e a height-expanded 3 confirmation 1 he middle 6b can be shdabh translated tow ard (lie first or pioximal 4 longitudinal end of the de ⁇ ice 2 "S (006 ⁇
- the top and/or base stability bais 8a and or 8c can be configured t ⁇ not dnect1>
- the Lop Oc and the base 6a can be pressed into or oihctvusc translated tow aid each 1 other t oi example, after implantation of the expandable support ice 2, the 2 surrounding tissue m the in ⁇ em ironment can naturalh compress the expandable 3 support des ice 2
- the tamps 10 can hav e i atchets on then sui faces m the tongue and
- a high friction material e ⁇ > PTFC such as Teflon
- Hguies 4a and 4b illustrate thai the top pen i4a, middle port 14b and base pou ⁇ i 4c substantial!) align parallel oi uansv erse w jth the longitudinal ax ⁇ > 4
- 1 K 6b can be suln.taRUalis tlush w ⁇ h the top (>c and bottom 6a w hen ⁇ lev, e ⁇ fi cm abov e w
- the height expanMon can octui when the device 2 is, 2 io ⁇ g ⁇ tudmall ⁇ compensate ⁇ sed and os when the mi ⁇ te 6b is slid, as shown b ⁇ auow Io with the fust side
- 26 bv aiiov* 40 can be deliveied against the bise 6a for example to allow the siding iou ⁇
- the remvm e force can be 8 delneied to the first side port, foi example diiectl ⁇ to the outci fiibt side port 2Ha ( ) (0O76
- the deplo>meni tod 44 can have an attached oi i ⁇ tegial depiojmeni
- 32 iod cap 46 oi nut thai can be outside the first port 2S and inteifeience in with the wall oi ⁇ the In st side plate 24a suirounding the first port 1 J0 ⁇ ?7
- the tod 44 tan be pulled ⁇ as shown by anon 36) while a iesisine f ⁇ ice (shown
- the second bide plate 24b and oi the lop 6c and ⁇ or the bottom ds tan ⁇ i amp 1 ⁇ abutment section, such as tlie iamp stops 18 ⁇ he tamp abutment section can be
- a rod detent 52 can be fitted onto ot though the deployment tool ot locking rod
- the uset can deploy a force against th € detent ⁇ 2
- the detent 52 can be a dtp, nut iv biad, loekable skde, ot cotnbuianons thereof
- the detent 52 can fh to the deployment
- the depioj ment rod or lockmy pm 44 can be integral oi 3 attached to the middle 6b, for example at the second stdc plate 24b 1 he middle port can 4 be unobstructed by the i od or pm 44 "> ⁇ 0083 ⁇ 1 he deploj ment rod 44 can be lem ⁇ v abh attached from the iemamdei of the
- veitebrae can 1 cm ⁇ ,( ) ⁇ in ) to about 5 i cm (2 in ) 0e ⁇ sees 2 for use in the lumbar ⁇ e ⁇ cbrae can ba ⁇ c a radius of curvature 54
- the locking tod 44 (not shown m Figure oa and 6b) can be to match the cuixatuie
- Figures 6a' and 6b' illustrate that a compressive force, as shewn arrows %, can
- the middle umps 16b can p it ⁇ s and against the 1 o co ⁇ espond ⁇ ig top tongues and ' or gioo ⁇ cs 20c
- the top 6c am expand ⁇ CJE ticaih , as
- the 2 can be uisetted nno a jeatraem aiea along a ed path foi iv example, the cuned path of delneo can have a substammlK equal iadtus of tuix atute to
- i-tgurc 7a illustrates that the second ssde port 42 tan ha ⁇ e port thread ⁇ S on ail or a 2 portion of the mside of the port I or example, the second 3 thtead ⁇ H on about half of the surface ofJhe inside of the port 42. foi example from
- the dcpiox ment rod or locking psn 44 can have rod OJ pin tJhiead 48 on ⁇ poiUon 8 of the sulfate of the tod or pin 44 corresponding to and substantially equal to or less than ( ) the pot uoH of the siu (ace of the inside of the port 42 eo ⁇ cied bv p ⁇ i t tluead ⁇ >> Fot
- the tod O ⁇ pni 44 can ha ⁇ e iod or pm thread 48 on about half of the swtacc of
- the iod pm thiead 48 can shdabK pass actors the innei surface of ⁇ the second side poU 42 not having pott thiead ">S
- the pm thread 4h can shde past (he
- pin 44 can be i oiated to align the rod or pin thread 48 w ith the pott thread 5h
- the iod t> ⁇ l> pin 44 can be i ⁇ mslatably fixed wuli tespect to the second side poit 42 for example
- the tut can be iotated w Uh respect to the rod or pin
- expandable ⁇ uppoM dc ⁇ ice 1 he locking pins can ⁇ rc ⁇ ens ⁇ v CM expansion and or 2 o ⁇ e ⁇ completion and O ⁇ dswsserabh of the expandable suppoit de ⁇ ice 3 J ⁇ 097]
- the tamps can hax e locking 4 pins insetted therethrough "> fOO*>S
- 26 poti can elongated ctoss-secuons such as an owii or tectanguiar oi oblong cr ⁇ ss-
- the locking ptn an he free to mo ⁇ e ⁇ erticalK w itJbm a iangc of motion v ⁇ ithi ⁇ 8 the locking pin port ( ) ⁇ Q®99 ⁇
- the l ⁇ ckma pm can be a subsUratialiv siniikt shape and sj/e as the locking ptn
- the locking pm can be substantial Socking pm port 1 lhe locking pm locking pin channel and locking pin poit can all elongated cioss- 2 sections such as an ouii oi recfangulai or oblong ⁇ uss- sections 1 J0 ⁇
- the iamps can has e first living teeth at ratchets
- the fust fixing teeth can be m
- the top and-'ot the bottom can have second fixmg 1 teeth
- 6 teeth can mtesa ⁇ to obsiiuct (e g , b ⁇ interference fitting the hxbi fixing teeth against the "7 second fixing teeth) ielam e translation m a second direction
- obsiiuct e g , b ⁇ interference fitting the hxbi fixing teeth against the "7 second fixing teeth
- ielam e translation m a second direction
- fixmg teeth can allow relative translation of the side ramps toward each
- the device 2 cars have a Hist ordisial end
- the first end tan be confirmed to
- dissect tissue lor example being sharpened to a point or chisel tip, or can be atraumatic
- the second or piovimal end can a too! connector such as in eucuiaih
- the fa i»t or distal side Hie tool connector can be con figured to 1 H attach to a deplo> ineru tool iv (01041
- the tamps can fitst fixing teeth that can unidtteeiionalK iinetference Ot
- the first fixmg teeth and the second fixing teeth can substantial!) impede or prex cnt the 2 opposite ramps from moving longjtadmalh aw ay from each other for e ⁇ ample, therefore 3 impede or the top 6c tow ⁇ jrd the bottom 6a and ⁇ tec ⁇ ers ⁇ j ⁇ ficr
- 26 teeth can allow the opposite uunps to mo ⁇ c longitiidinailv toward each othei lbi
- thcieforc allow ing the top to expand and ⁇ ice ⁇ 8 [ ⁇ 1O6
- expandable support deuce 2 can be patually oi s ⁇ bstantmllv filled ⁇ uth a liquid gel or
- the filler material can comae L oi be m uear contact with the simoundmg tissue neat the
- the expandable support devices 2 can textured and/or porous surfaces for
- expandable support 2 can be coated with a bone growth factor, such as a calcium
- the thin metal scieen can expand and/or
- 11 apparatuses described herein can be made from, for example, a single or multiple
- PFT polypropylene, poiytetrafltjoroethyl ⁇ ne
- P TFb poiytetrafltjoroethyl ⁇ ne
- ePTF F expanded PI l-F
- PEK poh-ether ketone
- PBtK polvether ether ketone
- PhKK poly ether letcme ketone 3
- nylon pel
- polymers e g.. PEBAXK fiom ATOFINA Paris, France
- aliphatic polyeth ⁇ r 5 polyurethanes e.g., TECOFLEX ⁇ from Thermedics Polymer Products, (> Wilmington, MA)
- PVC polyurethat ⁇ e, thermoplastic, fluorinaied 7 eth> leue prop) lene
- FtP fluorinaied 7 eth> leue prop) lene
- absorbable or resorbable pol> mers such as polyglycolic acid 8 (PGA), polylactic acid (PLA), pohcapiolactone (PCl.), poK ethyl acn Sate (PEA) 9 polydtoxanone (PDS) and pseudo-poiyarcuno tyrosme-bisscd acids, extruded collagen, 0 silicone, /me, echogemc. radiopaque materials, a bior ⁇ atenal (e g.. cadaver t tissue, collagen, allogiaft. autouraft.
- PGA polyglycolic acid 8
- PLA polylactic acid
- PCl. pohcapiolactone
- PES poK ethyl acn Sate
- PDS pseudo-
- radiopaque materials ate barn m sulfate ⁇ /tnc ovsde ttiamum, btamiess steel
- estei e g.. DACRON H Dora E I Du Pom de Nemouis and
- XS AIDs non-steroidal anti-mfiammatones
- COX-D inhibitors c g , a cet ⁇ acid, for example A.SPSRI ⁇ R N fiom Ba>ei AO,
- Lev eil ⁇ & ⁇ i Gcimanv. ibupiufen for example AD ⁇ Il 4 ⁇ from W yeth, CoIi ege ⁇ J ⁇ ie. PA, 0 mdomcthacm, mefeiianiic acid), COX-2 aih ⁇ itots (e g , VSOX ⁇ fc fiom Merck &.
- the expandable support ices 2 can be iases cut, machined, cut by v, ste
- JbDM electrical discharge machining
- expandable support de% ice 2 can be cut in u foil) contracted CM unexpanded configiualion
- the expandable Nippon device 2 can be louguudm ⁇ li> segmemed Multiple iv expandable suppoi t de ⁇ ice ⁇ 2 can be attached fit st end 4 to second end O, and or a single
- expandable support device 2 can be sexered iongtttidinallv into multiple expandable
- Figure 8 illustrates that the expandable support ice 2 can be loaded m a 5 collapsed O e . contracted) configuration oMo a depio> mem tool 132 1 he depio) mem
- 26 tool 132 can be configured to rermnablv attach to the fust side tamp and the second side 2 n tamp
- One nr more deployment iooK can be configured to control the position of the 8 expandable support device (e g,, to rigidly attach to the expandable support dc%icej and or ( ) to longitudinally eomptess the second side ramps., and ox to deploy one or mote locking 0 pins iti the expandable suppoit ice
- the meet tool can include a rigid OJ 1 llex ⁇ ble catheter 136 2
- Figure 9 illustrates that the deployment tool can longitudinally compress the 3 expandable support, deuce for example causing the e ⁇ pandable support device to
- 3 x crtebra 142 can have a damage site 146, for example a compression iractoe
- ⁇ access tool 148 can be used to gain access to the damage sjte 146 and O ⁇
- tool 148 ⁇ aii be a rotating oi ⁇ ibiatmg drill 1 % ) that can e a
- the dull 150 ma> oscillate, as show o b> arrow x 154
- Figure J2 illustrates thai the access too! 14K can be ftanshited as shown h ⁇ amn ⁇
- the access tool 148 can eieate an access
- first depiovment tool 162 can be translated, & > show n b> aiiow 168, to portion a first
- a second depioxmeni tool 1"4 can enter Commissionough a second mciSion ! 76 ⁇ as shoun)
- the second deployment tool 174 can be steetable ⁇ he second "> deployment tool 174 can be sieeied as shoAii b> arrow 184, to ahgn the distal tip of the 26 second expandable buppott tee 46 v, jth a second access port 1 £6 on a second damage 2 *1 site 1 W
- the second access port 186 can face ante ⁇ otlv iH2
- J 74 can translate, as shown b> arrow 190 to portion tlic second expandable support ( ) tec 46 m [lie second damage sue 18S
- the ⁇ etteka ! 42 can multiple damage sites and expandable 1 siippoil deptoved tlierein I he expandable suppos i can be deploj ed fiom 2 ⁇ he ame ⁇ oi 1 ⁇ 2 poste ⁇ oj 16 7 , both lateral, superi ⁇ r inferior any angle oi combinations ⁇ ⁇ of the directions ⁇ eteoi Ol couise.
- a ssrsgle des ice ma> be deplos ed koni one dst ectr ⁇ i ⁇ 4 nither than multiple de ⁇ ices, from multiple directions 1 J0 ⁇ 25
- the deplo ⁇ men ⁇ tool 132 can be deploved off-cemei. for example, when
- Figure 22 illustrates tliat the access pon 160 can be made ciobc to the di->c 144 for
- FIG. 21 [ ⁇ 13O
- a 3 fii st expandable support ice (not show n) can be inserted through a fii st access pot t 4 172 and deplo ⁇ ed in a first damage site 1 "7 O
- snd n second expandable support de ⁇ ice (not "> show n) can be mseiied thiough a lust access pon 172 and deployed in a second damage 26 sue 188
- the first access port 172 can be substantially ccmcied with iespect to the first 8 damage site 1 "1 O
- the first expandable Mir ⁇ oit dc% ice f not shownj can expand, a ⁇ ⁇ hown ( ) arrows 64. aibstantiallv supe ⁇ orh and snte ⁇ otK.
- the second access pon 1 b ⁇ can be substantial not centered with 1 iespect to the second damage sue I *t ⁇ llie second expandable si ⁇ poit ctes ice can 2 substantially anchor to a side of the damage sue 146 and or the suiface of the disc 144. 3 and then expand, as skmn by ⁇ uo ⁇ s w), subst ⁇ jn»ai!> awa> from the ⁇ se H 144
- the access memet 160 can h,ne an access poit dsaraeiet r ⁇
- 8 diametei 392 can on from about i 5 mm ⁇ 060 m ) to about 40 mm (2 JO ), An example
- the access poH diameter l l) 2 can be a result of the si/c of the
- the deployed diameter 194 can be from about ! S mm (0060 in ) to about H i 20 mm (4 ⁇ * m ), for example from about 10 mm (04 m ) to about 20 mm (0 8 m ) oi
- Figure 25 illustrates that the deployment tool I >2 can be removed, ⁇ is shown
- Figure 26 illusUates that the expandable support ice 2 can be loaded onto the iv deployment tool 132
- the expandable suppoit device 2 can be positioned adjacent to the
- disc 144 can be between a first vertebra 142a and a second ⁇ ertcbra i42b
- FIG. 21 [ ⁇ l36
- expandable support de ⁇ ice can increase the gap the l ⁇ isi ⁇ ertcbra S 42a and the 1 second x ertebra 142h ( e g , to restoie propei or OJ igmai biomechanics and or anatomical 2 geometn ) 1 J0 ⁇ 38J Psguie 29 illusttiatcs that the deployment t ⁇ l ⁇ ⁇ 2 coil be disconnected from the
- 8 figuj e 31 illustrates that the deployment tool 132 can tt an si ate and totate the expandable
- 10 de ⁇ tee can be kmgmi ⁇ nally compressed and radialh expanded, as show n b ⁇ arrow s
- the deplojmcni tool 132 can be removed from the target sue The 1 or
- ⁇ he dex ices 2 can be oriented so the longitudinal axes 4 of the deuces 2 cue 4 substantial!) paialle! ⁇ Hh an ante ⁇ or-postenor axis MO oi the patient "S (0142) 1 he fust st longitudinal axis 4a can be
- the second 2b can be oncnicd so the second ice longitudinal axts 4b 8 can be 2b ( ) can be positioned m a substamialls vssmrae'iic location and anguiai ouentation to the first
- Multiple deuces 2 can be del ⁇ eted ton ⁇ nrentlv oi seqitcnualiv i
- Multiple deuces 2 can be ladiallx expanded sequential! v or cnncinrenth
- the 2 can be mseued w ⁇ b a surgical technique such as an Antenor
- 30 back TLlF can reduce the amount of s ⁇ igica! muscle dissection nn ⁇ can tninmii/cs ⁇ C ⁇ e 1 manipulation required to access the ⁇ ertebrae, discs and nenes 2 ⁇ 0151 J I L ⁇ - can include leraox ing disc mates ?al from the spine m ⁇ inserting the ⁇ deucet ⁇ and bone i-iaU BMP sctews tods ot combination* thereof 1 J0 ⁇ 52
- the target sue ( or the icc(:») 2 CL ⁇ be between sacral, inmbai thoracic ceuicai
- the iaiget site can be between other bones, such as
Abstract
An expandable support device for tissue repair is disclosed. The device can be used to repair hard or soft tissue, such as bone or vertebral discs. A method of repairing tissue is also disclosed. The device and method can be used to treat compression fractures. The compression fractures can be in the spine. The device can be deployed by compressing the device longitudinally resulting in radial expansion.
Description
1 TITLE OF THE INVENTION
2 EXPANDABLE SUPPORT DEVICE AND METHOD OF USE
3
4 5
6
7 CROSS-REFERENCE TO RELATED APPLICATIONS
8 J0001 j This application claims priority to U.S. Provisional Application No. 61/187,538,
9 filed 16 June 2009, which k incorporated by reference herein in its entirety. « 1 BACKGROUND OF THE INVENTION 2 1. Field of (he Invention 3 (0002 j This invention relates to devices for providing support for biological tissue, for4 example to fuse vertebral bodies, repair herniated discs, and/or repair spinal compression 5 fractures, and methods of using the .same. 6 7 2. Description of Related An S {0003| Some conditions of the spine result from degradation or injury to the bone9 structures of the spine, typically the vertebral body. These can be the result of bone0 degeneration such as through osteoporosis or trauma, such as compression fractures. 1 breakdown or injury to the boney structures in the spine can result in pain and spinal2 deformity with comorbidities. 3 |0(MMj Vertebroplasty is an image-guided, minimally invasive, nonsurgical therapy used4 to strengthen a broken vertebra that has been weakened by disease, such as osteoporosis5 or cancer. Vertebroplasty is often used to treat compression fractures, such as those6 caused by osteoporosis, cancer, or stress. 7 |00051 VertebropJasty is often performed on patients too elderly or frail to tolerate open8 spinal surgery, or with bones too weak for surgical spinal repair. Patients with vertebral9 damage due to a malignant tumor may sometimes benefit from vertebroplasiy. The0 procedure can also be used in younger patients whose osteoporosis is caused by long-term 1 steroid treatment or a metabolic disorder. 2 |0006| Vertebroplasty can increase the patient's functional abilities, allow a return to the3 previous level of activity, and prevent further vertebral collapse. Verlehroplasty attempts4 to also alieviaie the pain caused by a compression fracture.
SUBSTITUTE SHEET (RULE 26)
1 (0ΘO7| Vaginoplasty is often aecmnphsiied uiiediug au orthopedic cement mixture
2 fhtough a needle into the fractured bone 1 he cement mixture can leak from the bone
3 potentially entering a dangerous location such as the spinal tanal The cement nmtuic,
4 which is naturaIK useous, is difficult to inject thiough small diameiei needles, and thus
5 many praetiuoπeis choose to "ilπn out" the cement mixture to nnpto\e cenwm injection,
6 u lndi ultmiateh exacerbates the leakage problems ϊ he flow of the cement liquid aUo
7 naturally follows the path υfleast teststaace once it enters the bone αatuiadv along the
8 αacks fotmed duπng the compiessson hactuie This fuπhei exacerbates the leakage,
9 JΘ008] I he mixture also fills or substantially fills the cavity of the compression fracture H) and is. hmited to certain chemical composition {hereto limiting the amount of otherwise
12 jϊteπiiUn e procedure know n as kyphoplasi v , a balloon ts fust inserted in the compression
13 fracture and the \ ettebra and is expanded to create a sosd befoie the cement is injected
14 into the new Iy formed space
15 jθ009| A veτtebropl3si"v device and method thai ehmmatcs* or tedoces the usKs* and
17 i educe or eliminate the need to inject a liquid direct!) into the completion ftactore /one
IH is also desued iv føOJOj ()ιh« ailments of the spine iestiit m degeneiauon of she spinal disc iu the
21 disease and traumatic mjuπes In either case disc degeneration can cause pam and other 2 complications Consm atn e treatment can include
treatment requiring 1 pauents to adjust their Wests lcs> and submit to pam reliefers and a ie\ e! of underlying
2^ leim. but also often increases the πsk of long-tain pioblems and can result in inotoi and
27 degeneration disease aie bkclv io lead to a need for surgical liealracnt m subsequent 8 } eon, ϊhc fusion or fixation v. ill mimmi/e or substantial!} eliminate rdatn e motion () between the fixed oi f used \ euebuie In Skiugical lreaiments adjacent \eitebra can be
30 fixated or fused to each othei using dexiccs ot booe grafts These ma\ include, fot
31 example, screw and rod s> stems, mteibody spaceis (e g , Pfc bk spacers oi allograft bone
32 giafts) threaded fusion cages and the like
33 jOOll) Some fixation oi fusiou devices are attached to the
ftonϊ the postenor M side Flic dc\ ice \s ill protmde and s esult m additional length ( t e needed to ov erlap the
1
Fusion cages
2 and allografts are contained vuthin the intervertebral space, but must he inserted into (he 1 mtenertcbrai spate m She same dimensions as desiied to occtnrv the mtenertebtal space
4 This tequnes that an opening sufficient to allow the cage oi graft must be eieated thiough
5 suuounding ussue to peiimt the cage or gtr ft to be wseued into the tntetveslebial space
6 [OOI2|
w ithoitt the need ^ for additional IiaaKsaie ΪS desπed Also desued is a fixation ot fusion device that can be
9 required
H) JΘ0I3] AUo desired is an intervertebral dexite the ma\ he inserted m to the mlmertebral
11 space at a Hist smallei dunensjon and deployed to a second, laxgei dmiensiυπ tu occup>
12 the jiiten αtebrai space The abihtj to insert an inteπ eitebral spaces at a dimension 1 ^ smallei than the depfoved dimension w ould permit less disπiptrøn of soft and bone>
14 tissue in ordei to access the mtervenebiai space
15 jθO14| Aπ effectne ιlictap"v ioi follow mj. up a discectυim is desned A
tusion 1 C' technique thai can be used subsequent to a Jhcectonπ is dcsuεd
17
1 H SUMMARY Or THE INVENTION iv f00J5j An expandable support
that can be used m iepair (tactures and stabilize
20 hard tissue such as \ ia mtra\ ertebral or mien ertebraϊ deplox mem, is disclosed T he
21 expandable suppoit dc\ ice can ha\ c a longittkimal axit. and a iadial a\is f he expandable 2 support
ice can be conikiued to expand m a iadial duection, for example constrained 3 to expansion in a single dimension I he deΛ ice can expand perpendicalit to the
24 longitudinal axis of the
ice can
top and or middle and or bottom 2"> components ϊ he top aπd-or middle and oi bottom components can
oi
2n and ot bottom components ate kaπsLucd rclatπ e to each othei m the Iongitudmal 8 diicction For example, the deuce can expand tadialh (e g soleh in height or width} ()
lonaitiidmalK Height expansion can octoi alone a vupeuor-mfeπoi
30 axis when the device is positioned m the spine
^ {0017) The tJeute can have a locking pin The locking pm can be mterfeience fit with
M nroving and or staiionaiv components of the rematrtdet of the dev ice For example the
1 ktekniL' pin can into feieuce fit w ύh the fust sϋuL and'Oi w itti a longitudinal port of the
2 dc\ ^c
5 concession The longitudinal αmipjesstou can result tn iadial expansion of the
8 site
9 |0019| Fools for deplo\ ing the expandable support device can be configured to apply a
10 compressn c force on She expandable support deuce along the expandable support
11 I he tools can be configuied io secure!) engage the
15 rotating a knob or handle
17 material such as a bone mcuphogenie ptolein, bone cement oi anv other mateπal listed
1 H herein and combinations theieof For example, w hen used to tieat compr«si>toa fractiu es, iv a nmieπal such bone cement, us^ue « bone gtowUi factois. bone morphogeny proteins,
20 stem cells earners Sbi anx of the foregoing, or mixtures thereof can be insetted v\ tthm the
21 expandable de\ ice to pτo\ idc support fixatJon and or improx cd bone stt ueiure Grow Sh 2 factors or stem ceils can be obtained autologous!) , such as from the patient's
3 or bone marrow aspirate [he expandable
ice can be filled with aotogi aft, ailogtaii, 4 bone extenders tc g , calcium phosphate ortπcalciura phosphate or mtxSυtes thereof or "> othei iimilai mateiuis), bone giow ih factor^., bone moiphogenic pioiems, stem cells, 26 cauieis tot anv of the foicgomg. and πuxtmes theteof (or example, when the de\ ice is 2n used as an niierxcttebral spacei fot fusion The giowth factois and stem cells used can be 8 those commercially
aifcώie and oi can be exti acted Aom the patient's
blood oi () bone raarraw aspirate 0 J0021] In addition the rauo of the expansion tot the expandable
{the iatio of the 1 unexpaiided height or diameter, depending on configuration, to the expanded height oi 2 diameter) ma> be from I 2 to 1 5 or greater i-or iniraxertebml and imeneπebial 3 αppiicauons the dev ice
expansion tatios of ftom about I 3 to about 1 4 Tm
can hax e an initial height or diameter
1 fiυin about 4 ram (0 16 m ) to about 8 mm (03 i in ) and an expanded height w diametw
2 ft otii about 7 mm (0 2H in ) to about 18 mm (0 7I m )
4 BRlCr DESCRIPTION Or TI IE DRAWINGS
5 [0022 j Figui «J 1 a i Slusti ales an exploded v tew of a \ adαuon of the dex ice
6 [ΘΘ23J Hguie Ib is a \ aπation of crnss-^eetion ia
8 I00251 Figut e 2b is a sanation oi cross-section B-B ot Fsgωe 2a.
9 JΘ026] Figure 3a illustrates a \anauori of the device in a height-expanded configuration
10 |0027] Figure 3b is a variation of cross-section C-C of Figure *a
12 configuration
13 [0029| tiguie 4b is a top new of a \ aπation of the deuce in a heigk -expanded
17 \ aπation of a cro^ -section C-C of Figure 3a
IH (0032 j Figures 5c and ?d Ulusnate vaπaisoαs of a method foi using the
see
a iv \ aπation of a cross-section C-C of Figure 3a with a depkmneiu tool and-or loclmg iod
20 {0033J F tgurcs 6a and 6b are side pei spccuve and top perspectn e \ tews, respcctn eiy or
21 a variation of the device in a height-contracted configuration 2 [ΘO34| hgures fia1 and 6b' are side perspective and top perspectn e \ lews, respectn eh , or 3 a 1V ariation of She
in a height-expanded configuration 4 [0035] Figures 7a through 7c are a close up ^ ie*\ of a method of using She deplo> men! "> iod or locking pm w ith the second side poκ shown in a cross-sectional
26 [0036] Figures 8 and 9 illuhUαw a sanation of α method for using a delivery system for
2n the expandable suppoti elcrncni 8 [0037| Figures i 0 through i 2 illusirate a x ariation of a method foi accessing a damage () .site in the s ei tebra. 0 JΘΘ38] Figute S 3 illusthrtes two methods fot
eπng expandable suppoit devices to the 1 \ ertebral column 2 |003*>] Figures 14 through V) illustiate methods for dep!o> mg the expandable 3 support
ice into the damage sue in the \ettebia
1 |Θ040| Psguies 2St and 21 iliushate a \ aiiatioti of a method foi depicting one in mote
2 expandable support de\ ices into one or moi e damage sites in the \ erlebia
3 J004I] Figure 22 illustrates a \aπaUαn of a method foϊ deploying the expandable support
5 |0D42j Figuie 23 illustrates vaπaUons of methods for depSov ing the expandable suppon
7 [0043 j F*guiei> 24 and 25 tliustiate a \ aπauoα of a method foi deploying the expandable
I 1 f©045J Figures 30 thiough 13 1 liusuate a \ aiiatioii of a method fur dep!o> ms* the
13 [0046| tiguies 34 and 35 illustiate aiaiwUion of a method foi deploying a locking pm
14 into the expandable suppoit de\ ice in the damage site in the vertebra
15 jθO47| Fsguies Mxi and 1^ 6b iUusliaic \ anal ions of methods foi inseituig one ot mote 1 C' de\ lies mto one or mote iaiget sues
17
20 that can be implanted m a bone such as s compiession Aacture m a \ ertebra, m the
21 mteneitebral ^pace between two vertebrae or in so R tissue, ^uch as a herniated 2 mteneπebral disc fhe expandable support
ice 2 can be biocompatible The 3 expandable support de\ ice 2 can be used, lot example, for methods of repairing \ crtcbral
24 bone ftaetiires oi supporting adiacent \ ertebrai hodiκ> foi foMon The expandable support 2"S 2 can
a fit st longitudinal end a.id a second longitudinal end alυng a
26 longs t iidinal atis 4
2n [0049| The expandable support dc\ ice 2 can
base oi botiom (w
and bottom 8 iuc used interthangeabh V a middle 6b, and a top component f>e The base or bottom fta () and top 6c can be ot
plates, panels sififc (e g . leμsi porfc, ceils, and combmations
30 thereof The base 6a i\nά top 6c can he configured to be slidabh attachable to the middle
31 6b fcnhei the top 6c, the base f>a, or neilhβ , tshown in the iigυies as Jie base 6a) can be
32 shdabl) attached to the middle 6b in a plane paiallei with the longitudinal aκis 4 hitliei
33 the top 6c the base 6a, oi neufiei, t show n m the as the top 6c) can be slidabK
M attached to the middle ftb m a plane sυbstaaually perpendicular to the longitudinal 4
1 (0ΘS0| The tup 6c can
e one oi mote top slabilits hats St Fot example, the tup
2 stability bars Hc can extend from the iaiciai sides of the top 6c I he fop subshtΛ bars Hc
4 more base stabihtv guxπes IUa Each top stability bai Sc can he confirmed, to be
^ slidabK attachable to a cunesponditig base stahshrv gioose I Oa Foi example, the top 6c
6 can have two seK of one, two or more symmetntalh opposite, lateiail) located top
ol tw o s>\ mnwscaJ!} apposite,
8 lateialiv located base siabihrs guxne.s H)a, as shown
9 |00511 Fhe base Oa can have one or more base stabthh bars Ha For example, the base
10 siabtiii) bars Ha can extend from the lateral sides of the base 6a lhe base slabiltf) bars
11 8a can extend fiom the base in the chrecuon of the top 6c I he top 6c can ha\ e one oi
12 more top stabihl} gtooses IUc The base stabihtΛ bar& Na can each be configtπed to be
14 can ha\e two sets of one, two, ihree (&> ^hown) oi raoie s>rameincalfy opposite fatera!l>
15 located base stabiliU bats 8a The top 6c can
e U\o or more sets* of Iw o. three f as Ut sh(mn) or more wrnmctπcaH\ opposne ia eraih located top stabihtv grooves 10c, as 1 "* ihow n
1 K {0052 J The shdable attachment υf the top H and base 6a can pei rou the base f>a to raov e iy iadialh {w tth jespect to the iongHudtual a Mb 4) telatt\e to Lhe top 6c and \ ice \eisa For
21 inseited in an mtcnertehrai target site 2 |0053 j i he top Oc can ha\ e a htgh-fπctton te\tute and or a low -fnction surface extending 1 a\\a\ Aom the base 6a on the surface faemg avun ft om the base 6a tor example the top 24 he can ha\ e one or numerous row s of top teeth 12c The bottom 6a can ha\ c a high-
fiυm the top be Foi example, the
27 bottom teeth can he rigid The teeth 12 can be at tanged to hax c ndges parallel w ith the 8 iongjtudma] axis 4,
w ith the iongitudtnal axis 4, at a non-zeio and noπ-nght () angle lυ the longitudinal a\Ls 4. oi combmations thef eυf The top aiid-or bottom sui faces.
31 fix the bones to the top 6c and or base ^a
32 {0054 J I he top 6c can b^ e one or more side ports and or top poits 14c 1 he base 6a can V* one oi moie base potts 14a amJ'Oi side pons The ports 14 can be cneuUi squate
1 tnauμuiai υ\ al elongated m ύic longituduud dueαsαn. elrugated in the iadial direction.
2 or combinations ihereof
4 The chainlets can euend along the peπmetei of the base 6a and or top 6c
8 length of ihe base
9 |0057| Fhe lop 6c and or base 6a can ha\ c a series of unidirectional and or bidrectional
0 O ramps For example, the top f>c can hav e a lop first ramp i 6c', a top second ramp 16c"
11 and a fop thud ramp 16c"' The umdnecuonal iamps 10a and oi 1 f>c can be configured to
12 have a rαmp stop IH at one longitudinal end of the ramp S 6a amioi 16c For example, the
13 ramp stop 1 H can be the face of the ramp that w closer to a petpendicuisr angle to the
14 longitudinal a\ts 4 than the othei iace of the ramp
16 as middle firvt ramp 16b' nuddie second ramp i 6b", and middle thud ramp i 6b"' The
17 umdiiccnonal ramps 16b can be configuicc" to
a ramp stop IH at one longitudinal IH end ol ilie ianip 16b iv |005£j The lamps 16 can ha\e lamp leagues and correspond groo\es 20 on adjacent
20 nimps Ramp tongue and groo% Cs 20 on corresponding ramps 16 can be configured to
21 ilidably attach to the opposing tongues and g
roo\ es 20 For Ac top ramps 16c 2 can top tongues and grooves The middle ramps 10b can
middle tongues and 3 grow es 20b that can slidabl> engage the top tongues and gioov es 4 [8MO] Fhe ramps 16 can haλe ramp angles 22 with ictpcct to the longitudinal axis 4 "S I he ramp angle 22 can be fiom about 1^° to about 7i;>t\ mote narrow K from about 20° to
26 about (AY for exaπiple about ^0
2n |00611 One or more of the lamps 16 can have ά tamp stop 18 The iamp slops Ih can be 8 configured to abut and mteifcrence fit against a cones ponding ramp stop i H on the () adjacent element O e . ihe top 6c can be adjacent to the middle Ob i 0 JΘΘ62] The base Oa {.as* skmπ) and OJ top 6c can
<ι fftst side plate 24i, for example 1 at the distal longitudinal end of the base 6a 2 |ΘO63) I he base 6c can
a base rail 26a Hie middle 6b can ha\ e a middle rail 2(>b 3 The middle rail 26b can be vhdabh fed owto or under the base rat! 26a The base tatl 2(>a
1 and the middle mi! 26b can coiisitaui motion bem ecn the middle 6b mid me ba.se
2 6a to the linear dimension of the longitudinal a\is 4
4 The fust side port can bm e a Hi st side cents al pon 28c in the top 6c The fiisi side cential
5 pon 2Sc can be open on the bottom, foi example to ailov the Ht st side cenUal pυit 2Sc to
6 moλ e av\ ay from the first side outer post 2Sa w ithout constraining any rod oi other
7 elongated element positioned through the i'tst side poit The middle 6b can ha\e a fust
8 side inner pou 2ISb tfuough the middle fust t amp S 6b', The first stde outei. central, aud l> inner ports 2Sa, 28c and 28b oi a combination thereof can be internally threaded The
0 O first side outer port 2Ha can form a recess in the first side plate 2Ha. for example to
11 iecen e the head of a i od
13 can be positioned to coπespond with and receB e one oi moie of the top lamps 16c, for
14 example w hen the de^ see 2 is in a height-contracted configuration
15 jθO66| The top lamps 16 can be positioned iatωaik s\mmeti it-ally on the top 6c The top
17 be positioned iateralh
base 6a 1 he ramp scats 30 can be
1 H distributed along the length of the ba^e (>a iv f0067j Figuies 2a and 2b illusttate that tbe deMce can have a height-conn acted
20 configuration fop ramps 16c can receive the middle ramps ϊ6b The ramp stops IH of
21 the top ramps i 6c can mterfeience fit agamM the ramp stops 18 of the middle ramps 16b 2
2 can e a height-expanded 3 confirmation 1 he middle 6b can be shdabh translated tow ard (lie first or pioximal 4 longitudinal end of the de\ ice 2 "S (006θ| The top and/or base stability bais 8a and or 8c can be configured tυ not dnect1>
26 attach to the top 6c and oi base da when the stabihn bar & is* translated toward the
27 opposite stability grπo\c tOa and or 10c, and or the stability bars M can be conllgiiicd to 8 bia* mwaid against and fπctionally hold the top 6c and base 6a togcthci uhen the top 6c () W translated into contact
stfa the base 6a 0 J0070] The Lop Oc and the base 6a can be pressed into or oihctvusc translated tow aid each 1 other t oi example, after implantation of the expandable support
ice 2, the 2 surrounding tissue m the in ^
em ironment can naturalh compress the expandable 3 support des ice 2 The tamps 10 can hav e i atchets on then sui faces m the tongue and
34 groove 20 snά or elsew here to enl coiiiraclion once the dex ice 2 is or
1 rαdiaih expanded The
2 can be filled a aiatcuai and oi tlie deployment tod
2 can be lived to the first s?de otitei port 28a ind the second port
5 and oi be coated w ith a high friction material (e {> PTFC such as Teflon)
6 [00721 Hguies 4a and 4b illustrate thai the top pen i4a, middle port 14b and base pou ^ i 4c substantial!) align parallel oi uansv erse w jth the longitudinal axϋ> 4 The top
8 middle and base ports 14a, 14b and 14c ftrro a concurrent \ eiticai pott 32 thiough the
9 dc\ tee 2 I he concun em vertical port 32 can be filled w tth an\ material disclosed herein
10 oi leit eniptv F he concurrent \ crtJcal poit 52 can be partiallv obbtnicted b\ the middle
12 ujnhguuttαn, a> shown in Figure 4a The αincuttent vertical port ^2 tan be less π obstructed oi substantialh unobstructed when the de\ ice 2 is in a height-expanded
14 configuration as shown so Hume 4b
15 (ΘO73| Fiauie 4a illustidtes that the middle 6b can pioirude outside of tiiε fooipruu of the Ut top 6c and bottom Oa when ihc
sec 2 is . tewed from above or below in a height-
1 K 6b can be suln.taRUalis tlush w αh the top (>c and bottom 6a w hen \ lev, eά fi cm abov e w
19 below ice 2 is in a haight-contt acted conllgutanon
20 |t)(.)74| Figures >a and >b illustrate the height expansion, as shown by arrow >4 of the top
21 όc tuun from the base ^a The height expanMon can octui when the device 2 is, 2 ioαgιtudmall\ compte^sed and os when the miάάte 6b is slid, as shown b\ auow Io with
the fust side
2"S ^8 against the top ramps 16c when the deuce 2 is expanded V resistive force as shown
26 bv aiiov* 40 can be deliveied against the bise 6a for example to allow the siding iouε
27 as show rt b> arrow s *6, to be dehvcied to the middle ^b The remvm e force can be 8 delneied to the first side port, foi example diiectl} to the outci fiibt side port 2Ha () (0O76| Fsguie ^c dlusUatεs that the middle 6b can ba\e a second ^ide poit 42 Λ
30 deployment tool an J or locking tod 44 can be inserted thtough the Hi st port 28 and the
31 second side poa 42 The deplo>meni tod 44 can have an attached oi iπtegial depiojmeni
32 iod cap 46 oi nut thai can be outside the first port 2S and inteifeience in with the wall oi ^ the In st side plate 24a suirounding the first port
1 J0Θ?7| The tod 44 tan be pulled {as shown by anon 36) while a iesisine fυice (shown
2 by at t cm 40} is applied to the de\ ice 2 to oppose the pulling foice < to expand the dev ice 2
6 thiead 48, as
tn Figures "7Si-Ic, configined to ieleasably ot frvedh attach to one OJ ^ both of the ramp poib 28 and oi 42 The pin thread 4K can extend along all CM pait oi the
8 length of ihe pm shaft
9 |(K)79| Fhe locking pm 44 can be inset led, as shov\n bv arrow th tough tlie threaded ramp
10 ports 42 and or 28 The dcpkn ment rod and locking pm can be the same or diffeiem
11 elements
12 [ΘΘ80] The second bide plate 24b and oi the lop 6c and<or the bottom ds tan
α i amp 1 ^ abutment section, such as tlie iamp stops 18 ϊ he tamp abutment section can be
15 deployment tool wheie the abuuπent end can be used to
tlie pushing ot pulling 1 C' foice Jgauist the proximal end of the dc\ tec 2 {<e g adjacent to the second side port)
17 jøOSl) A rod detent 52 can be fitted onto ot though the deployment tool ot locking rod
1 H 44 The uset can deploy a force against th€ detent ^2 The detent 52 can be a dtp, nut iv biad, loekable skde, ot cotnbuianons thereof The detent 52 can fh to the deployment
20 κ>d Ot locking pm 44 and mterfetenec ill against the middle 6b For example, the middle
21 6b can then be fixed between the rod detent ^2 and the first Mde plate 24a 2 [00821 hgute 5ά illustiates that the depioj ment rod or lockmy pm 44 can be integral oi 3 attached to the middle 6b, for example at the second stdc plate 24b 1 he middle port can 4 be unobstructed by the i od or pm 44 "> {0083} 1 he deploj ment rod 44 can be lemøv abh attached from the iemamdei of the
2n to position and expand ihc
tee 2 8 [Θ084 j f-igui os 6a and 6b illustrate that the de\ see 2 can ha^ c a an \ ed configuration Foi () example, the lonμjtodnial axis» o( the
can hav e a n\&m o( cur\ at me 54 The
30 Jongitυdmal axis 4 can pasi, through the tians\ eiie middle ol all potnb along the length υf 1 the
(0 5 m \ to about "> 6 2 cm (3 in }. more naπøvtlx from about 5 cm (2 in ) to about 7 cm (2 75 in } foi example ^ about ς cm (2 in ) The radius ofcutvatute ^4 ca« be Lonstanl or variable υvef the length M of the
^4 can be scaled larger for larger implants and
i i
1 scakd smαiltM for smaSlet implants For example tecs 2 tot use in the thoiaeic
2 •veitebrae can
1 cm {,() ^ in ) to about 5 i cm (2 in ) 0e\ sees 2 for use in the lumbar \ eπcbrae can ba\c a radius of curvature 54
4 I torn aboui 5 cm (2 in ) to about 6 4 cm (2 T in )
5 |0D85j The configuration of the top (u,, middle Ob, b<u»e ^a. ot combinations thereof can
6 be ciji \ ed to match the curv ature πf the de\ to? 2 The elements, of the top 6t , middle 6b
of the 2
9 of the dc\ tee 2
12 deployed agαmsi the middle Ob on the piovima!
of the
ice 2 and against the first 1 ^ side plate 24a and or first side outei port 2Sa on die distal side of the de\ ice 2
14 [ΘO87f Phe middle 6b can slide m a eun ed path along the longitudinal axis 4 w ith respect
15 to the top 6c and oi bottom 6a The middle umps 16b can p
it^s and against the 1 o coπespondπig top tongues and' or gioo\ cs 20c The top 6c am expand Λ CJE ticaih , as
17 show n b> arrow 34, awa> from the bottom 6a
IH |0088| The
2 can be uisetted nno a jeatraem aiea along a ed path foi iv example, the cuned path of delneo can have a substammlK equal iadtus of tuix atute to
20 the raduts> of ciin aiiirc ^4 of She de\ ice 2
21 [0089| i-tgurc 7a illustrates that the second ssde port 42 tan ha\e port thread ^S on ail or a 2 portion of the mside of the port I or example, the second
3 thtead ^H on about half of the surface ofJhe inside of the port 42. foi example from
24 angles about 0 degi ces to about 1 SO degrees \\ hen measured from a ioπguuduia! a\is
2"> passing through the centei of the second Side poa 42 (as shown) oi fiom about 0 Jegiees
26 to about 0O degrees and then again fiom about I SO degrees to about 2"0 degrees
2n [0090| The dcpiox ment rod or locking psn 44 can have rod OJ pin tJhiead 48 on ά poiUon 8 of the sulfate of the tod or pin 44 corresponding to and substantially equal to or less than () the pot uoH of the siu (ace of the inside of the port 42 eo\ cied bv pυi t tluead ς>> Fot
30 example, the tod OΪ pni 44 can ha\ e iod or pm thread 48 on about half of the swtacc of
31 the outside of the rod or pin 44, for example from angles about 0 degi ees to about 180
32 degrees w hen measuied from a longitudinal axis passing through the center of the tod or ^ pm {as shown) or from about 0 degrees to about 0O degrees and then again fiυm about M ! 80 degrees to about 21) degrees
1 J0Θ9Ϊ| The non-tlaeaded put lion of the stuiate of the tod 44 can be angukth aligned
2 w lib the threaded portion of the surface of the second side poi i 42
3 {0092J Figure "D illustrates thai the rod or pin 44 can be translated into ot through the
4 second side port 42 The iod pm thiead 48 can shdabK pass actors the innei surface of ^ the second side poU 42 not having pott thiead ">S The pm thread 4h can shde past (he
7 [0093 j figuie 7c iliustiaie-* that when the rod or pm 44 is at a desned powuoα ihe tod oi
8 pin 44 can be i oiated to align the rod or pin thread 48 w ith the pott thread 5h The iod t>ι l> pin 44 can be iπmslatably fixed wuli tespect to the second side poit 42 for example
10 because of an tnterleiencc fit between {he pm ihiead 48 and the port thietid *uS
12 be on a sepaiate nut rouiiabh attached to the second side poit 42 For example, once the H rod oi pm 44 is in a desired position, the tut can be iotated w Uh respect to the rod or pin
5 S theiefote the second side port 42
10 J0095] A biocompatible adhesn e ot cpox\ cjn be applied to the pin tkead 4h threaded
17 iamp port 42, abutment end ramp abutment section, or combinations thereof
IH (0096) One, mo oi mote lucking ptn chao«eb oi poits can be inserted iongUudmalK into iv the expattdable suppon de\ fee One, t\\ a oτ raoie locking pitis can be i»ϊ»et ted into the
20 same or sepai ate ports foi example duimg or after deployment of the remainder of the
21 expandable ^uppoM dc\ ice 1 he locking pins can ρrc\ ens σv CM expansion and or 2 o\eι completion and OΪ dswsserabh of the expandable suppoit de\ice 3 JΘ097] Once the
see ?s expanded and oi before expansion the tamps can hax e locking 4 pins insetted therethrough "> fOO*>S| 1 he locking pm 44 can be c\ hnduαi I he locking pm channel mid locking pin
2n sections The locking ptn an he free to mo\ e \ erticalK w itJbm a iangc of motion v\ ithiπ 8 the locking pin port () \Q®99\ The lυckma pm can be a subsUratialiv siniikt shape and sj/e as the locking ptn
30 channel The locking pm can be substantial
Socking pm port 1 lhe locking pm locking pin channel and locking pin poit can all
elongated cioss- 2 sections such as an ouii oi recfangulai or oblong αuss- sections
1 J0ϊøø| The iamps can has e first living teeth at ratchets The fust fixing teeth can be m
2 contact w ith the top and or the bottom The top and-'ot the bottom can have second fixmg 1 teeth
4 fOlOI) The fust fixing leεth can mechamcrlly inteiact with the second fixing teeth to
5 aliow reiatrve nansialiou m a first direction The first [rung teeth and the second fixing
6 teeth can mtesaα to obsiiuct (e g , b\ interference fitting the hxbi fixing teeth against the "7 second fixing teeth) ielam e translation m a second direction For example, the faing
9 dc\ tee to contract and obstruct the top from men nig closer to the bottom Also for H) example the fixmg teeth can allow relative translation of the side ramps toward each
12 [Θ102J The device 2 cars have a Hist ordisial end The first end tan be confirmed to
13 dissect tissue, lor example being sharpened to a point or chisel tip, or can be atraumatic
14 for example being blunted
16 and<'or internal H threaded c\ lindci extending longftudmallv from the second oi pioximaϊ
17 side and aw a\ fiom the fa i»t or distal side Hie tool connector can be con figured to 1 H attach to a deplo> ineru tool iv (01041 The tamps can
fitst fixing teeth that can unidtteeiionalK iinetference Ot
20 second fixing teeth on adjacent ramps or ramp seats The unidirectional interference iit of
21 the first fixmg teeth and the second fixing teeth can substantial!) impede or prex cnt the 2 opposite ramps from moving longjtadmalh aw ay from each other for eκample, therefore 3 impede or
the top 6c tow <jrd the bottom 6a and \ tec \ ers<j δ ficr
24 the ice 2 is, insetted and deplo\ ed in a taiget site
2"> (0105J 1 he unidirectional mtei feience fit of the fii st fixing teeth and the second fixing
26 teeth can allow the opposite uunps to mo\c longitiidinailv toward each othei lbi
2n example, thcieforc allow ing the top to expand
and \ ice Λ
8 [Θ1O6| \n externa! dcploymeni tool can be attached to the in si side plate and the second () pott of die side of the deuce amlapplv a compiesbne lbtce actoss the device The base
30 and top can expand aw ay from each other, as show n bv arrows
32 expandable support deuce 2 can be patually oi sαbstantmllv filled \uth a liquid gel or
33 solid ie g in small parts oi gmuuies) fillet material ot combinations theieof, as
M bone morphogeny ponder or an) othei material disclosed herein or combinations thereof
1 The filler material can comae L oi be m uear contact with the simoundmg tissue neat the
2 edge of the pom
3 J8108] The expandable support devices 2 can textured and/or porous surfaces for
4 example, to increase fricϋon against bone surfaces, and/or promote tissue ingrowth. The
6 base.
7 [ø ϊ 09j The expandable support de\ see 2 can be covered b\ a thm metal screen, for
8 example over at least the top and/or base ports. The thin metal scieen can expand and/or
9 open when the expandable support device 2 expands
10 \Q\ 10] Any or ail elements of the expandable support device 2 and or other devices or
11 apparatuses described herein can be made from, for example, a single or multiple
12 stainless steel alloys, nickel titanium alloys (e.g , Nitmol). cobalt-chiome allots (e.g ,
13 EL<jlLOY-J<x from Elgin Specials Metals, Hlgm, IL; CGNICHROME^ from Carpenter
14 Metals Corp., W) omissmg, PA), nickel-cobalt alloys le g , MP35N £ from Magellan
15 Industrial Ttading Company, lnc , Westport. CT), molybdenum alloys (e g., molybdenum 1 o TZNl allo> . to* example as disclosed in Internationa! Pub. No. WO 03 082363 A2,
17 published 9 October 2(503, w hich is herein mcorporaled by reference in its entirety),
IH tungsten-rhenium, alloys, for example, as disclo&ed m International Pub. No. WO
IV o3''OH23f>3s polymers such as polyelliyletie teraphathalate (PET)φoiyesιer (e.g.,
20 DACRONsF' from b. 1 Du Pont de Nemours and Company. Wilmington, DL),
21 polypropylene, (PFT). poiytetrafltjoroethylεne (P TFb), expanded PI l-F (ePTF F), 2 poh-ether ketone (PEK), polvether ether ketone (PBtK), poly ether letcme ketone 3 (PhKK) (also poly aryl ether ketone ketone), nylon, pel) cthcr-block co-poiyarmdc
24 polymers (e g.. PEBAXK fiom ATOFINA Paris, France), aliphatic polyethβr 5 polyurethanes (e.g., TECOFLEX^ from Thermedics Polymer Products, (> Wilmington, MA), ρol> \ my! chloride (PVC), polyurethatϊe, thermoplastic, fluorinaied 7 eth> leue prop) lene (FtP), absorbable or resorbable pol> mers such as polyglycolic acid 8 (PGA), polylactic acid (PLA), pohcapiolactone (PCl.), poK ethyl acn Sate (PEA) 9 polydtoxanone (PDS) and pseudo-poiyarcuno tyrosme-bisscd acids, extruded collagen, 0 silicone, /me, echogemc.
radiopaque materials, a biorøatenal (e g.. cadaver t tissue, collagen, allogiaft. autouraft. xenograft bone cement morselled bone, osteogenic 32 der, beads of bone } anj of the othet materials listed herein or eoitibiiutiυns thereof
1 Examples ui radiopaque materials ate barn m sulfate^ /tnc ovsde ttiamum, btamiess steel
2 nickel- titanium alloys, tantalum and gold
5 agents and or a malax a maϋix foi cell mgrowih oi used with a fabiic, foi example a
7 be, lot example, po!> estei (e g.. DACRON H Dora E I Du Pom de Nemouis and
10 pi 12] F he expandable support de\ see 2 artior element of the expandable support
11 2 and/or oilier de\ ices or apparatuses descubed herein and oi the fabnc can be
12 filled, coated, ia\ ered and or othct w ise made \\ ύh ARU or from cements ftilers, giue^
14 therapeutic and OJ diagnostic agent λn> of these cements ami/or fillers and or glues can
15 be osteogenic and osteomducti \ e giowih factors
10 |0113] of »uch cements and oi fillers mcrudes bone chips de-minerab/ed bone
1 K calcium phosphate, poh methyl methaci ylate (PMNΪΛ). biodegt adabk cei araics, bioactn e iy glasses, ϊwaiiuoruc acid, lactofetuπ, boue UKiiphogeotc piotems ( BMPs) such as»
20 recombinant human bone morphogcnelie protcms. (rhBM Ps), other materials described
21 herein, or combinations thereof 2 |0 ϊ Ϊ4[ fhe ayems withm these raatuces can uiciude an> agent disclosed he; em or ^ combinations thereof, including radioaciπ e materials, ladiopaque mateuaK, c\ togcntc 4 agentN, cytotoxic agents, cytostatic agents, thrombogenic agents, for example 5 pol>urelhane. cellulose acetate poh mer mixed vt ith bismuth tπoKide. and eth\ lene \ m 1
27 foi example non-steroidal anti-mfiammatones (XS AIDs) such as cvcSooλvgeikisc- i 8 (COX-D inhibitors (c g , a
cet\ acid, for example A.SPSRI\ RN fiom Ba>ei AO, () Lev eilα&ωi, Gcimanv. ibupiufen for example AD\ Il 4< from W yeth, CoIi ege\ JΪie. PA, 0 mdomcthacm, mefeiianiic acid), COX-2 aihώitots (e g , VSOXλ fc fiom Merck &. CQ , 1 liic . Whitehonse Siatsnn, Nj, CELtBRfc\κN fiom Pharmacia Corp , Peapack, NJ, COλ-i 2 inhibitors);
\M U NH ^ from 3 Wvetii
P \) or matrix metailoprotemase (MMP) inhihiton {& g
34 tetracycline and tetracycline donatives) that act earl) ^ tth«i the pathways of an
1 mπammutof} tεsponsε FκampU:s of oihei agents aie pπnsded in Walton e! ai. Inhibition
2 of Prostoglandm F> Sy nthesis m Abdominal AotUc Aneiitvsros, Circulation, Jttij 6 \9Ψ) T1 4,s»54 Iambiah et ai, Provocation of Experimental Aortic Inflammation Mediators and
4 Oilam>dia Pneumoniae, Brit J Swxen 88 {,"?), 935-*->40. Ftankhn « aL Uptake of
5 Teuacyeltne bv Aortic Aneurvsni Wall and Its Effect on fnlknimauon and Ptoteol>sis,
7 m Hypoxic Vasculat Endothe! turn, J Biological ( 'hem^ ity 275 (32 } 245S3-245K1) , and
8 Pvo el ai. Tasgeied (ϊene Disruption of Matπx Nfetal!opjoιeinase-V> (Gelatinase B)
^ Suppresses Development of Experimental Abdominal Aorue Aneurysms, ./. ( lniicat
10 Inveiftgation 105 ( J ] ), 1 (A 1 - i hΦ> which are ai I incorporated by reference m their
11 entireties
13 electrical discharge machining ("JbDM") or made by other suitable techniques I he
14 expandable support de% ice 2 can be cut in u foil) contracted CM unexpanded configiualion
15 or nia\ be cut in a partial! v opened pattern, then loaded (e g , CJ imped) onto a deployment 10 tool i 32 (e s balloon 1 "U) The loaded expandable support
2 can hare a smallci
17 profile while plastically deforming the struts H' past their limits
IH \§U6] The expandable Nippon device 2 can be louguudmαli> segmemed Multiple iv expandable suppoi t de\ ice^ 2 can be attached fit st end 4 to second end O, and or a single
20 expandable support device 2 can be sexered iongtttidinallv into multiple expandable
21 support devices 2 3 Mh I HOD OF LSh 4 [8117] Figure 8 illustrates that the expandable support
ice 2 can be loaded m a 5 collapsed O e . contracted) configuration oMo a depio> mem tool 132 1 he depio) mem
26 tool 132 can be configured to rermnablv attach to the fust side tamp and the second side 2n tamp One nr more deployment iooK can be configured to control the position of the 8 expandable support device (e g,, to rigidly attach to the expandable support dc%icej and or () to longitudinally eomptess the second side ramps., and ox to deploy one or mote locking 0 pins iti the expandable suppoit
ice The
meet tool can include a rigid OJ 1 llexϊble catheter 136 2 |0118j Figure 9 illustrates that the deployment tool can longitudinally compress the 3 expandable support, deuce for example causing the eλpandable support device to
3 x crtebra 142 can have a damage site 146, for example a compression iractoe
4 $120] Λα access tool 148 can be used to gain access to the damage sjte 146 and OΪ
^ met ease the we of the damage sue 146 to aikm deployment of the expandable suppoit
^ handle 152 Optionally, the dull 150 ma> oscillate, as show o b> arrow x 154 The di ill
9 to pass into the damage site i 46
10 pi2I] Figure J2 illustrates thai the access too! 14K can be ftanshited as shown h\ amn\
11 118 to e tissue at the damage sue 14f> The access tool 148 can eieate an access
14 [Θ122f hgiue I^ iliustiates that a first deployment tool 162 can enter posterior \y ihrough
15 the ^ubjett's back The fhs>t dcpknmeiu too! 162 can entet thtougli a lust uicistion 164 in
17 first depiovment tool 162 can be translated, &> show n b> aiiow 168, to portion a first
1 v be on the postet ioi side 1 ft? of the s erlebi a 142
20 {0123J A second depioxmeni tool 1"4 can enter ihrough a second mciSion ! 76 {as shoun)
21 m the sktn i 66 \ he second mcision. 1 ">(■>
be posterior (as show n > or mav be antcπoi 2 lateial poiteπot lateial ot the kke lhe second depiosraem too! 174 can be Mandated 3 thtou^h muscle (not srκπ\ nl, aiound nent^ i 78, the spinal cord 180, and anlenor I S2 of 4 the column 140 The second deployment tool 174 can be steetable ϊhe second "> deployment tool 174 can be sieeied as shoAii b> arrow 184, to ahgn the distal tip of the 26 second expandable buppott
tee 46 v, jth a second access port 1 £6 on a second damage 2*1 site 1 W The second access port 186 can face anteπotlv iH2 The second deplo\mem 8 too! J 74 can translate, as shown b> arrow 190 to portion tlic second expandable support () tec 46 m [lie second damage sue 18S
30 JOl 24] As illusUatαi, the \ etteka ! 42 can
multiple damage sites and expandable 1 siippoil
deptoved tlierein I he expandable suppos i
can be deploj ed fiom 2 {he ameπoi 1^2 posteπoj 167, both lateral, superiυr inferior any angle oi combinations ^ ^ of the directions ώeteoi Ol couise. a ssrsgle des ice ma> be deplos ed koni one dst ectrøi ^4 nither than multiple de\ ices, from multiple directions
1 J0Ϊ25| Figutεs 14 ami 1 ^
iliusiiate uaubhu ng ai» b\ aiiow ihe depkn men. iool
5 140 The deplo\menι tool 132 can be deploved off-cemei. for example, when
6 appi oachmg the posterior side I <V7 of the \ β£ tebϊ al col u mn 140
"7 [0 ( 26f Figuie I X illubtiates thai deploy meitt tool 132 can position the expandable suppui t
9 J(Jl 27] Figure ! 9 illustrates thai the expandable support de\ ice can be longif tulmalh
11 substantial!) fixed to the \ ertehia 142 The expandable support de\ ice 2 can ieshape the
13 [0 f 28| tigui es 20 and 21 illustiate that fit sf and second deployment tools 162 and 1 "4
14 can position and depio> first and second expandable suppon devices 40 and 46
15 simultaneously and oi m the same \ eitebra 142 and into the s»aiτιc oτ dtffcient damage 10 Mies 170 and I RR
17 J0129) Figure 22 illustrates tliat the access pon 160 can be made ciobc to the di->c 144 for
1 H example w hen the damage site 146 is close to the disc 144 The deplo>raeπt too! 132 can iv be iaseited tluough the access pon ! 60 and the expandable suppoti dev ice 2 can be
20 deployed as described supra
21 [Θ13O| Figure 2 ϊ a front \ ιew of the vertebral column 140, illustrates that more than one 2 expandable support de^ ice 2 can be deplo\ ed into a single \ ertebra 142 For example, a 3 fii st expandable support
ice (not show n) can be inserted through a fii st access pot t 4 172 and deplo\ ed in a first damage site 1 "7O, snd n second expandable support de\ ice (not "> show n) can be mseiied thiough a lust access pon 172 and deployed in a second damage 26 sue 188
2n [013 ϊ J The first access port 172 can be substantially ccmcied with iespect to the first 8 damage site 1 "1O The first expandable Mirφoit dc% ice f not shownj can expand, a^ ^hown () arrows 64. aibstantiallv supeπorh and snteπotK. alι»ned with Ae center of the first 0 access port 172 The second access pon 1 bύ can be substantial not centered with 1 iespect to the second damage sue I *tø llie second expandable siφpoit ctes ice can 2 substantially anchor to a side of the damage sue 146 and or the suiface of the disc 144. 3 and then expand, as skmn by α
uo^s w), substαjn»ai!> awa> from the ώse H 144
V)
1 jøt J2| Psguie 24 illusttiatcs tiiat \\ iieu compιess>n e tension frυin the deplo> meπt tool ts
2 no longer exerted on the expandable suppoi dc\ice the expandable support dex ice can be
4 tension ϋ> stopped The expandable support
see can then be substantia!! v fixed to the
support tee can be 6 subject to biomeehanical compression w ithm one oi betv\ een tuo \ enebrae
^ [0I33J The access puit 160 can h,ne an access poit dsaraeiet rø The access port
8 diametei 392 can on from about i 5 mm ψ 060 m ) to about 40 mm (2 JO ), An example
9 about K mm (0 3 in } The access poH diameter ll)2 can be a result of the si/c of the
12 diameter 194 The deployed diameter 194 can be from about ! S mm (0060 in ) to about H i 20 mm (4 ~* m ), for example from about 10 mm (04 m ) to about 20 mm (0 8 m ) oi
14 from about 12 ram (04"? m ) to about 16 mm (0 6"? »i ) 1 he deployed diametei 194 can
15 be grealeϊ than, equal to oi less than toe access port diameiei !92
16 JΘ134] Figure 25 illustrates that the deployment tool I >2 can be removed, <is shown
17 fi ØIΪI the \ erteHra 142 after the expandable siippoϊ i dc\ ice 2 is deploved
1 H (0135) Figure 26 illusUates that the expandable support
ice 2 can be loaded onto the iv deployment tool 132 The expandable suppoit device 2 can be positioned adjacent to the
20 disc 144 [he disc 144 can be between a first vertebra 142a and a second \ ertcbra i42b
21 [βl36| Hgure 27 illustrates thai the expandable suppott device 2 can be inserted nno the 2 disc 144, foi example mto the nuclear space or into the annular space Remo\ al of none, 3 pan ot all of the nucleus and oi annul us tan be performed before placing the expandable 4 suppoϊt
ice 2 in the disc 144 "> (0137) Figure 2s: illustrates that the expandable suppou
ice 2 can be sadtaSK
2n matrix teeth, or combinations theicoi'on tiie top ot bottom of the expandable vuppoit 8 deuce 2 can engage the first oi secon i 42a or 142b oi both The expandable () .support
ice can fuse oi fix the lust
42a to the second
142b The
30 expandable support de\ ice can increase the gap
the lϊisi \ ertcbra S 42a and the 1 second x ertebra 142h ( e g , to restoie propei or OJ igmai biomechanics and or anatomical 2 geometn )
1 J0Ϊ38J Psguie 29 illusttiatcs that the deployment tυυl \ ^2 coil be disconnected from the
2 expandable support de\ ice 2 1 he depioyinent tool \ i2 can be rεmo\ cά Horn the space of
3 the disc 144 with or \\ ithout the expandable support dev. see 2
4 [0139] Figures K) thiough 33 Ulissttαte a method of d
epio\mg the ofthe
2 Figure 30 illustrates thai the expandable sυppυi I
2
8 figuj e 31 illustrates that the deployment tool 132 can tt an si ate and totate the expandable
10 de\ tee can be kmgmiώnally compressed and radialh expanded, as show n b\ arrow s
11 Figuie 33 iliustiates that the deplo> meat too! B 2 can Be sepai ated fiom the expandable
14 [Oi 4Oj hgιue:> 34 and 35 tiiusuate that a locking pin 1% can be inserted, a^ shown b>
15 aiiow uuυ the deployed expandable support
ice 2, for example after the expandable 10 support
ice 2 is deployed in the vertebra 142 The 'ockmg pm 1% c<in prevent the
1 H deplo} ed in the \ ertebra 142 The locking pm I % caa lbs m an mtei {ensαce Ot w ith the iv expandable suppoj t de\ ice 2 or may include featωes to hήύ the locking pm m place
20 pi4ϊ J Figures ^6a illustrates that one, two or more de\ ices 2 such as a first device 2a
21 and a second
2b, can be inserted, depkn ed and or implanted the targes sue, such as 2 in a \ ertebral bod} 324 or oo a \ eriebia) bod\ 324 (e g between adjacent \ enebral 3 bodies) ϊhe dex ices 2 can be oriented so the longitudinal axes 4 of the deuces 2 cue 4 substantial!) paialle! \\ Hh an anteπor-postenor axis MO oi the patient "S (0142) 1 he fust
st longitudinal axis 4a can be
26 MΛκLsnπally paialld with the aτitenυj-poskteτiot &\ιs >2U
2n |0i43| The second
2b can be oncnicd so the second
ice longitudinal axts 4b 8 can be
2b () can be positioned m a substamialls vssmrae'iic location and anguiai ouentation to the first
30 de\ ice 2a w ith respect to the antetior-postcriot axis 320 1 {01441 l he coπcaxnv ofthe rødsus of cunature 54 of tlie deuce can lace tow aid (as 2 shown} or av*a> fiøm the medial direction (i e , the eenti al aateπoi-posteπoi axis 32!»)
33 {0145) Λftei placed into position at the taiget site the deute 2 can be longitudinally
2i
1 rαdialH expanded and the fust device 4a has beets delncied to the tmaet stte and not vet
2 radialH expanded Multiple deuces 2 can be delπeted tonαnrentlv oi seqitcnualiv i Multiple deuces 2 can be ladiallx expanded sequential! v or cnncinrenth
5 Lumbal lrueibod> fusion (ALIF), shown
arrow 322a, Posieuot Lumbal {ulerbodv
6 Jhu&ion (FLIF), shown bv attow 322b, \ rarfeibrammal Lumbar Meϊbody Hision ( TLIF), ^ show α b> an ovi 322c a duect hneat lateral delner>, as» shown b> arrow 322d, a
8 eumluieai iateiai deiπen mitialis inserted postenotiv, as shown bs at tow 322e, ot othet
9 methods or combinanoni thereof
10 pi47] Operate e planning and icmpiaung cart be performed ifcing MRi and C \ T
12 [Θ148J The dnc O e
Uu get ^ite utiuhcn be prepared Fof 1
\ eitebrae can be accessed thioυgh an mcision HI the paueni s back
14 (i e , po^ienor to the %eitebrαe) Depending on the numbei of \ ertebi ai levels to be feed
15 about a "*-6 inch musion can be made in the patient's back The spinal miisciεs taa then 1C' be retracted (or separated) fot example to allow a
ccc^ to the tat set discs The 17 lamina uiπ then be rcmo\ ed (t c , a ianimettom> ), for example Io be able to sec and
1 H access the mi \ e loot;. The facet loints, w hsch can he direct K OΛ ei the «es \ e ϊoots, can iv be mmmed, foi example, \o Mow more room ioi the neπe roots The target disc and
21 be prepared (e g , cleaned abraded, debnded textured scored, toatcd with osteogenic 2 pow ders oi other agents OJ combinations thereof) 3 JΘ149] fhe
sees 2 can then be mooned into the target site One or mojc
sees 2 4 and oi bone graft {c c , autograft allograft,
BMP oi eombmaUons iheicof, "> can be mseiteά into the target site or disc space, for example to piomote fusion bem een 26 ihe seitebuie Additional Jiistiumeiitation ^e g rods oi suews>) can also be used at llits 2n lime to turthe* stabih/e the spine 8 j(i!50{ TLiI- can include dehvenng the dexitc 2 to fhc spme in a path more from the wdc () of tlie spmal canal than a PI IF appioach and throimh a midline incibfon HI the patient b
30 back TLlF can reduce the amount of sυigica! muscle dissection nnά can tninmii/cs ΏCΪ\ e 1 manipulation required to access the \ ertebrae, discs and nenes 2 {0151 J I Lϊϊ- can include leraox ing disc mates ?al from the spine mά inserting the ^ deucet^ and bone i-iaU BMP sctews tods ot combination* thereof
1 J0Ϊ52| AUF is pei formed inserting the flora the ftont lanteaυr) of the bods usually
3 im oh c cutting through and later lcpantng ώe muscles m the lower abdomen
5 the muscles and allow access to the iϊont o^the spine thiough ΛΏ incision This, appioach
6 maintains abdominal muscle strength and function and can be used lo fuse the L^-Sl disc
7 space , lot example
8 jøϊ 541 Once the iucisiou is made and the \ ertebrae aie accessed, and afles the abdominal l> muscles and blood \ easels ha\ c been tetracted, the disc materia] car) be rcmm cd 1 he
11 combinations thereof, for example to subtls/e the spine and facilitate fusion
13 or combinations theieof The iaiget site can be between other bones, such as
14 intercostal (betw eeπ nbs) m the knee, eibom , w πst. ankle, or combinations thereof
15 jθi56| Fsguie
2 tan be inserted into Ut the target sue such as m a
bock or on ά xertcbia! bod^ (e g , between adjacent 1 "* x enebral bodies) 1 he longitudinal
4 of the
2 tan be ot iented
IH peφendicuiar to (he anteπoi-posteuo! aλis 320 M e , paiailel to a lateial axis) The iy conαn ύ\ of die iadius of cm vaiure 50 can face anteuotiv ot posteπotiv
20 |0l57j 1 be de\ ice 2 tan be filled v\ ith a filled before or after radial expansion Tissue
21 ingrowth can occur into the top plate through {he top ports bottom plate through the 2 bottom ports, and elsew here through the
3 ((Jl 58] PC I Application No L S20<^ 034,728, Publication Ko WO 2006 (W>8,ό82,
24 entitled 'Fxpandable Sυppott ϊ)e\ see and Method of Use" filed 26 September 200^ and 2"! U b isional Patent Application No 60 612 728, filed on 24 Sepiembei 2004, are
27 [0l5θ| It is apparent to one skilled m ihc ait that \atious changes and mυdiilcations can 8 be made to this disclosure, and
departing fiorn the spirit () and scape of the uneiition Flcmcπis .shown with anv v ariation ate everaplmy far die
30 specific \ aπation and can be used on othci \ aπatωπs v\ uhin this disclosure Any
31 elements described herein as singular can be pUirali/ed {i e , an> thing described as ' one"
32 can be more than one) Any species element of a genus element can has e the
33 ehaiaclemtics or elements of anv othei species dement of that genus The M described conilgurations, elements oi complete assemblies and methods and their
2^
elements foi earning out the invention, and variations of aspects of the invention can be combined and modified with each other in any combination
Claims
1 CLAIMS
2 We claim
3 I An expandable orthopedic implant comprising
4 a first lαad-beanng element
5 a second load-beat ing element,
6 a sliding element Uidably attached to the first load-beanng element and the second "7 load-beaimg element, wheietn the sliding element has fust, second and third sliding
9 clement and wherein the first load-hearing element has a litst second and third load- It) bearing ramp features, and wherem the first second mid third sliding element ramp
11 features are configured to press against the first, second and third ioad-beai ing iamp
12 features, respectively , when {he sliding clement is tunsϊated vuih iespeci to the fust load-
13 bearing element, and u hetem the ttanslation of the sliding element w ith respect to the
15 second load-bearmg element.
1 C' wheiem the device has iadins of curvature, and wherem the radius υf cur\ .nitre is
17 not infinite and non-/ero
IH
IV 2 The of Claim I, svhereui the first sliding element t amp featute has a fust tooth
20 configured io tύlow unidirectional sliding against the first load-beartng element
2 ! 2 5 ϊ he de\ ice of Claim 2, w herein the second wedge has a first losd-bearm^' tamp ieatme 3 is configured to allow unidirectional sliding agamst me first sliding element 24
2"> 4 The device of Claim 1. funhei comprising a locking pin
26
2n 5 The ice of Claini 4, wherein the locking pin is attached to the first load-beanng 8 element ()
30 f> The dc\ ice of Claim 4, whet em the locking pun is attached to the sliding element
31
2^
1 8 Tlie άc\ ice uf Claim ! \s heteiu the radium of cut \ a Line v <mes> along a longitudinal
4 v The deuce of C faun ! wheieni ibe tadius of cnruitute ^ gieater than aboia 0 ς m and
^ ϊe«vs than about 3 m
6
8 a f ifsi ioad-beai ing element l> a second Ioad-beai ing element
11 and the second load-bearing element and wheiem the tiansiation oi the sliding eiemem
12 w uh iespeci to the fii st load-beat ing element causes the Hist loαd-bearsng clement to 1 aw av fiom the second load-bearing element
I s* mi \ dtuie is not infinite and noiweio
10
17 H A method for supporung an mfen ertcbral target wtc bet een a first xertcbra and a
1 H second \ a tebra compx jsmg iv itfoeitmg a device having a longitudinal avis mto the target site, wheiem the
20 device comprises a first ioad-beaung clemtnt, a second load-bearmg element and a
21 sliding element and w herein the sliding element is attached to the fitst load-bearing 2 element and the second load-beaπng element and w herein the longitudinal axis has 3 iadrus atuie, and herein the udius of cunaiure is not infinite and noiwero
24 traiiNlating the sliding element u ith
to the first load-beaπng clement 2">
awa\ fiυm the 26 second load-beaung element
Applications Claiming Priority (2)
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---|---|---|---|
US18753809P | 2009-06-16 | 2009-06-16 | |
US61/187,538 | 2009-06-16 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2010148112A1 true WO2010148112A1 (en) | 2010-12-23 |
Family
ID=43356742
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2010/038857 WO2010148112A1 (en) | 2009-06-16 | 2010-06-16 | Expandable support device and method of use |
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WO (1) | WO2010148112A1 (en) |
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