WO2006020928B1 - Therapy provision to adjacent motion segments - Google Patents

Therapy provision to adjacent motion segments

Info

Publication number
WO2006020928B1
WO2006020928B1 PCT/US2005/028847 US2005028847W WO2006020928B1 WO 2006020928 B1 WO2006020928 B1 WO 2006020928B1 US 2005028847 W US2005028847 W US 2005028847W WO 2006020928 B1 WO2006020928 B1 WO 2006020928B1
Authority
WO
WIPO (PCT)
Prior art keywords
distal
vertebral body
proximal
driver
intervertebral disc
Prior art date
Application number
PCT/US2005/028847
Other languages
French (fr)
Other versions
WO2006020928A3 (en
WO2006020928A2 (en
Inventor
Stephen D Ainsworth
Robert L Assell
Andrew H Cragg
Eugene A Dickhudt
Tawney A Schwarz
Bradley J Wessman
Original Assignee
Trans1 Inc
Stephen D Ainsworth
Robert L Assell
Andrew H Cragg
Eugene A Dickhudt
Tawney A Schwarz
Bradley J Wessman
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Trans1 Inc, Stephen D Ainsworth, Robert L Assell, Andrew H Cragg, Eugene A Dickhudt, Tawney A Schwarz, Bradley J Wessman filed Critical Trans1 Inc
Priority to EP05785115A priority Critical patent/EP1786341B1/en
Priority to AU2005272596A priority patent/AU2005272596B2/en
Priority to AT05785115T priority patent/ATE536822T1/en
Priority to JP2007525852A priority patent/JP4993500B2/en
Priority to CA002577071A priority patent/CA2577071A1/en
Publication of WO2006020928A2 publication Critical patent/WO2006020928A2/en
Publication of WO2006020928A3 publication Critical patent/WO2006020928A3/en
Priority to NO20071350A priority patent/NO20071350L/en
Publication of WO2006020928B1 publication Critical patent/WO2006020928B1/en

Links

Classifications

    • 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
    • A61B17/8875—Screwdrivers, spanners or wrenches
    • 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
    • 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
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8645—Headless screws, e.g. ligament interference screws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/025—Joint distractors
    • A61B2017/0256—Joint distractors for the spine

Abstract

Disclosed are methods and apparatus for the provision of spinal therapy to two or more adjacent motion segments accessed through a trans-sacral approach. The spinal therapies include fusion and dynamic stabilization with and without a distraction of the most cephalad motion segment of the two or more adjacent motion segments provided therapy. The disclosure includes methods and apparatus to impart a distraction on a second more caudal motion segment after providing therapy to the more cephalad motion segment. Related concepts for the extraction of previously inserted devices and the delivery and removal of plugs for plugging the interior cavities of implantable devices are disclosed.

Claims

67
AMENDED CLAIMS
[received by the International Bureau on 15 January 2007 (15.01.2007)]
63. An assembly comprising a distal device and a proximal device; the distal device comprising: a distal end; at least one set of threads for engagement with at least one vertebral body; and a proximal end with a cavity having an engagement zone; the proximal device comprising: a distal end with an extension adapted to fit at least a portion of the extension within the engagement zone in the cavity of the distal device; a threaded section for engagement with a vertebral body; and a proximal end with a driver engagement section.
64. The assembly of claim 63 wherein the extension is adapted to be a close fit to a corresponding portion of the engagement zone to maintain the axial alignment of the proximal device and the distal device while retaining the ability for the proximal device to rotate relative to the distal device without imparting rotation to the distal device.
65. The assembly of claim 63 wherein the proximal device further comprises, a shoulder that surrounds the extension on the distal end of the proximal device SUGK that upon sufficient axial advancement of the proximal device towards the distal device, the shoulder portion of the proximal device abuts against at least a portion of the surface area of the distal device,
66. The assembly of claim 63 wherein upon sufficient axial advancement of the proximal device towards the distal device, the extension of the proximal device abuts against at least a portion of the surface area of the engagement zone in the distal device.
68. The assembly of claim 63 wherein the distal device further comprises a first set of male threads for engagement with a distal vertebral body and a second sζt αf 68
male threads with the same handedness for engagement with a less distal vertebral body.
69. The assembly of claim 68 wherein the first set of male threads and the second set of male threads on the distal device have the same pitch.
70. The assembly of claim 68 wherein the first set of male threads on the distal device has a finer pitch than the second set of male threads on the distal device such that rotation of the distal device after engagement of the first set of threads with* the distal vertebral body and the engagement of the second set of threads with the less distal vertebral body causes ah axial distraction of the distal vertebral body relatijve'tδ the less distal vertebral body.
71. The assembly of claim 70 wherein the first set of male threads on the distal device has a major diameter and the second set of male threads on the distal device has a minor diameter that is larger than the major diameter of the first set of threads so that the first set of male threads can pass through a previously formed bore in the less distal vertebral body without the need for rotation of the distal device and the creation of a thread path in the less distal vertebral body.
Figure imgf000004_0001
distal vertebral body relative to the less distal vertebral body.
73. The assembly of claim 68 wherein the distal device is adapted to provide therapy to a motion segment comprising the distal vertebral body, the less distal vertebral body, and the intervertebral disc space between the distal vertebral body and the less distal vertebral body by insertion of material into the intervertebral disc space through fenestrations in the distal device. . 69
74. The assembly of claim 70 wherein the first set of male threads on the .distal device has a major diameter and the second set of male threads oh the distal device has a minor diameter that is smaller the major diameter of the first set of threads and a major diameter that is larger than the major diameter of the first set of threads.
75. The assembly of claim 73 wherein the spinal therapy provides for dynamic stabilization of the motion segment and the material inserted into the intervertebral disc space expands a flexible portion of the distal device.
77. The assembly of claim 63 wherein the distal device is provided with-, φ proximal end with a set of threads for engagement with one vertebral bodyiajad; '|| distal tip of the distal end for placement in an intervertebral disc space between? .Jh^ one vertebral body and a more distal vertebral body and the distal device is adapted to insert material into the intervertebral disc space between the one vertebral body and the more distal vertebral body.
78. The assembly of claim 77 wherein the distal device further comprises a flexible component in the portion of the distal device intended for placement in the intervertebral disc space between the one vertebral body and the more distal vertebral body; and the distal device is adapted to insert material into the intervertebral disc
Λ - vl-v space between the one vertebral body and the more distal vertebral body. -
79. The assembly of claim 78 wherein the distal device is adapted to jnsejξj: material into the intervertebral disc space between the one vertebral body and* the more distal vertebral body by receiving material through a central axial cavity to expand the flexible component outward from the distal device and into the intervertebral disc space.
84. The assembly of claim 63 wherein: the cavity in the proximal end of the distal device having a socket for receipt of a corresponding polygonal driver for the transfer of rotational forces from the 70
11 '. ' ? driver to the distal device to rotate the distal device with respect to the at least one, vertebral body; the cavity in the proximal end of the distal device having a threaded section for receipt of a corresponding set of threads on a distal end of a disengagement tool, the threaded section having an opposite handedness to the threaded section on the distal device for engagement with the vertebral body so that a disengagement tool can be rotated to engage the disengagement tool with the distal device and after completion of the threaded engagement impart a rotation to the distal device to disengage the distal device from the at least one vertebral body such that once disengaged from the at least one vertebral body but still engaged with . the disengagement tool, the disengaged distal device can be removed with the distal enα of the disengagement tool from the channel. .s} '- i?
85. The assembly of claim 63 wherein: the driver engagement section in the cavity in the proximal end of the proximal device comprising a socket for receipt of a corresponding polygonal driver for the transfer of rotational forces from the driver to the proximal device to rotate the proximal device with respect to the vertebral body; the cavity in the proximal end of the proximal device having a threaded section for receipt of a corresponding set of threads on a distal end of a disengagement tool, the threads having an opposite handedness to the threaded section on the proximal device for engagement with the vertebral body so that^a disengagement tool can be rotated to engage the disengagement tool with the proximal device and after completion of the threaded engagement impart a rotation to the proximal device to disengage the proximal device from the vertebral body such that once disengaged from the vertebral body but still engaged with the disengagement tool, the disengaged proximal device can be removed with the distal end of the disengagement tool from the channel. 71
92. The assembly of claim 63 wherein: the distal device: is adapted for use in fusing together a motion segment comprising a vertebral body, an adjacent and more distal vertebral body and the intervertebral disc space between the intervertebral bodies, the distal device having the cavity along the centerline of the longitudinal axis in fluid communication with a set of at least one fenestration so that material provided to the proximal end of the distal device can be delivered into an intervertebral disc space and to insert material into the intervertebral disc space that promotes fusion;, and -■■**•■ the proximal device: is adapted for use in fusing
Figure imgf000007_0001
vertebral body, an adjacent and more distal vertebral body arid the intervertebral disc space between the intervertebral bodies, the distal dejvice having the cavity along the centerline of the longitudinal axis in fluid communication with a set of at least one fenestration so that material provided to the proximal end of the distal device can be delivered into an intervertebral disc space and to insert material into the intervertebral disc space that promotes fusion; such that the assembly can be used in providing fusion therapy to two adjacent motion segments accessed through a trans-sacral approach. • -V
93. The assembly of claim 63 wherein: the distal device: . . ,iV, further comprises a flexible component in the portion of the distal device intended for placement in the intervertebral disc space between a vertebral body an adjacent and more distal vertebral body and the distal device is adapted to insert material into the intervertebral disc space between a vertebral body and the distal device by receiving material through a central axial cavity to expand the flexible component outward from the distal device and into the intervertebral disc space; and the proximal device: 72
is adapted for use in fusing together a motion segment comprising a vertebral body, an adjacent and more distal vertebral body and the intervertebral disc space between the intervertebral bodies, the distal device having the cavity along the centerline of the longitudinal axis in fluid communication with a set of at least one fenestration so that material provided to the proximal end of the distal device can be delivered into an intervertebral disc space and to insert material into the intervertebral disc space that promotes fusion; such that the assembly can be used in providing therapy to allow dynamic stabilization of a distal motion segment and to provide for fusion of an adjacent and more proximal motion segment, both motion segments accessed through a trans-sa'cral approach.
94. The assembly of claim 63 wherein: the distal device further comprises a flexible component in the portion of the distal device intended for placement in the intervertebral disc space between a vertebral body an adjacent and more distal vertebral body and the distal device is adapted to insert material into the intervertebral disc space between a vertebral body and the more distal vertebral body by receiving material through a central axial cavity to expand the flexible component outward from the distal device and into the intervertebral disc space; and ■< * .. ^i the proximal device further comprises a flexible component in the poitilgjiifrjf the proximal device intended for placement in the intervertebral disc space betw^efra vertebral body an adjacent and more distal vertebral body and the proximal device ;s adapted to insert material into the intervertebral disc space between a vertebral body and a more distal vertebral body by receiving material through a central axial cavity to expand the flexible component outward from the proximal device and into the intervertebral disc space; such that the assembly can be used in providing therapy to allow dynamic stabilization of both a distal motion segment and an adjacent and more proximal motion segment, both motion segments accessed through a trans-sacral approach.
98. A driver for use in delivering a component inside a patient as accessed through a channel created through a trans-sacral approach to a motion segment in the spinal column, the driver comprising: a shaft with a distal end and a proximal end; a driver head on the distal end of the shaft for engagement with a corresponding section on the proximal end of a component; a retention rod within the shaft with a distal end of the retention rod that is threaded, the distal tip of the retention rod extending from the shaft so that it can threadedly engage a corresponding set of threads on the proximal end of the component; and a rotational actuator on the driver to allow selective rotation of the retention rod to selectively engage or disengage from the set of threads on the proximal Pnd^f the component such that the retention rod can be engaged with the proximal ejaii- QΪ the component before the component and the attached driver are inserted through the channel created through a trans-sacral approach and the retention rod can be disengaged with the proximal end of the axially implantable device after the component has been threadedly engaged.
99. The driver of claim 98 wherein.: the driver has a handle at the proximal end to facilitate rotation of the driver to impart rotation through the driver head to the proximal end of the component; the retention rod extends through the handle and the shaft of the driver to:, fh^e distal end of the shaft; the handle is between the distal end of the retention rod and the rota|(ona| actuator, the rotational actuator attached to the retention rod and sized to precludie movement of the rotational actuator down through the handle and to the distal end of the shaft so that the retention rod is removed from the driver by moving the distal. end of the retention rod through the shaft and out through the handle. 74
100. The driver of claim 98 wherein the driver head is a male polygonal engagement section to engage with a corresponding female polygonal socket in, -the proximal end of the component and the distal end of the retention rod has a set of male threads for engagement with a corresponding set of female threads in a cavity on the proximal end of the component.
101. The driver of claim 98 wherein the driver head is a female polygonal engagement section to engage with the proximal end of the component and the distal end of the retention rod has a set of male threads for engagement with a corresponding set of female threads in a cavity on the proximal end of the component.
102. A spinal therapy device for deployment in a channel created through a,t£anj£ sacral approach, the spinal therapy device comprising: a distal end; a proximal end; a cavity at the proximal end of the device, the cavity located internally along the longitudinal centerline of the device; a threaded section on the external surface of the device for engaging a vertebral body; the proximal end of the device having a tihreaded section on the internal surface for receipt of a corresponding set of threads on a distal end of a disengagement tool so that a disengagement tool can be rotated opposite to the direction for engaging the vertebral body to engage the disengagement tool wi^ihe device and after completion of the threaded engagement impart a rotation to/ tB.e device to disengage the device from the vertebral body such that once disengaged from the vertebral body but still engaged with the disengagement tool, the disengaged device can be removed with the distal end of the disengagement tool from the channel.
103. The invention as described and illustrated in the specification and referenced figures. 75
104. A method to axially distract a second intervertebral disc space between a second vertebral body and a third vertebral body after inserting a distal device into the second vertebral body and at least a portion of the first intervertebral disc space between the second vertebral body and the first vertebral body, comprising the steps: inserting a distal end of a distal device through the third vertebral body, the second intervertebral disc space, the second vertebral body, and into the first intervertebral disc space through a previously formed channel by rotating the distal device so that threads on the proximal end of the distal device engage with the second vertebral body; inserting a distal end of a proximal device through the third vertebral body and into the second intervertebral disc space through the previously formed channel by rotating the proximal device to engage a set of threads on the proximal end of; tjif proximal device with the third vertebral body; and wherein continuing rotation ι#th§ proximal device engages the distal end of the proximal device with the proximaj^end of the distal device without causing rotation of the distal device engaged in the second vertebral body, the rotation of the proximal device moving the third vertebral body relative to the second vertebral body engaged with the distal device to distract, the second intervertebral disc space,
105. The method of claim 104 wherein the step of rotating the distal device causes threads to engage with the first vertebral body and the second vertebral body, the thread pitch of the threads engaging with the first vertebral body having the same pitch and handedness of rotation as the threads engaging with the second vertebral body such that rotation of the distal device causes the movement of the distal φyϊff in the cephalad direction without altering the axial distance between the first vertξbrjaϊ body and the second vertebral body. •■'-, ?
106. The method of claim 104 wherein the step of rotating the proximal rod to engage the set of threads on the proximal end of the proximal rod with the third vertebral body is achieved by engaging the distal end of a rod driver into a cavity in the proximal end of the proximal rod, the cavity comprising a socket for receipt of a 76
corresponding polygonal driver for the transfer of rotational forces from the driver to the proximal rod; the method further comprising the additional steps of removing the inserted proximal rod through: placing the distal tip of a disengagement tool adjacent to a portion of the cavity in the proximal end of the proximal rod, the portion of the cavity having a threaded section for receipt of a corresponding set of threads on a distal end of the disengagement tool, the threaded section being of the opposite handedness of the set of threads on the proximal end of the proximal rod; rotating the disengagement tool to engage the disengagement tool with the threaded section in the proximal rod; *• to, continuing the rotation after completion, of the threaded engagement cto impart a rotation to the proximal rod to disengage the proximal rod from;thf third vertebral body such that once disengaged from the third vertebral body but still engaged with the disengagement tool, the disengaged proximal ■ -rod can be removed with the distal end of the disengagement tool from the channel.
107. A method of inserting a component into a human body through an access channel while maintaining a positive engagement between the component and a driver for the component while the component and the distal tip of the driver move through at least a portion of the access channel, the method comprising: .,, ;f! rotating a threaded section of the distal tip of a retention rod with a rqtajiqn actuator located on a portion of the driver that will remain outside of the actces| channel, the rotation causing a threaded engagement between the distal tip of,,the retention rod and the proximal end of the component until the component is affixed to the distal end of the driver and engaged with a driver head on the driver that corresponds to a driver receiving section in the proximal end of the component; inserting the component and the distal end of the driver into the access channel until distal tip of the component is in proper positions for a threaded engagement; 77
using the driver to rotate the driver head to cause rotation of the component to achieve a threaded engagement; rotating the threaded section of the distal tip of the retention rod with, the rotation actuator to disengage the threaded attachment between the distal tip of the retention rod and the proximal end of the component; and after disengaging the retention rod from the component which is now in threaded engagement, removing the distal end of the driver from the access channel.
108. The method of claim 107 wherein the disengagement of the threaded attachment between the. distal tip of the retention rod and the proximal end of the component is performed before the completion of using the driver to rotate the driver head to cause rotation of the component to achieve the threaded engagement.
109. The method of claim 107 wherein the disengagement of the thr.ead§| attachment between the distal tip of the retention rod. and the proximal end of the^ component is performed after the completion of using the driver to rotate the driver head to cause rotation of the component to achieve the threaded engagement.
PCT/US2005/028847 2004-08-14 2005-08-15 Therapy provision to adjacent motion segments WO2006020928A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
EP05785115A EP1786341B1 (en) 2004-08-14 2005-08-15 Therapy provision to adjacent motion segments
AU2005272596A AU2005272596B2 (en) 2004-08-14 2005-08-15 Therapy provision to adjacent motion segments
AT05785115T ATE536822T1 (en) 2004-08-14 2005-08-15 TREATMENT OF ADJACENT MOVEMENT SEGMENTS
JP2007525852A JP4993500B2 (en) 2004-08-14 2005-08-15 Providing treatment to adjacent motion segments
CA002577071A CA2577071A1 (en) 2004-08-14 2005-08-15 Therapy provision to adjacent motion segments
NO20071350A NO20071350L (en) 2004-08-14 2007-03-13 therapy shaping and adjacent movement segments

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US60184204P 2004-08-14 2004-08-14
US60/601,842 2004-08-14

Publications (3)

Publication Number Publication Date
WO2006020928A2 WO2006020928A2 (en) 2006-02-23
WO2006020928A3 WO2006020928A3 (en) 2007-03-01
WO2006020928B1 true WO2006020928B1 (en) 2007-04-12

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PCT/US2005/028847 WO2006020928A2 (en) 2004-08-14 2005-08-15 Therapy provision to adjacent motion segments

Country Status (8)

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US (4) US7776042B2 (en)
EP (1) EP1786341B1 (en)
JP (1) JP4993500B2 (en)
AT (1) ATE536822T1 (en)
AU (1) AU2005272596B2 (en)
CA (1) CA2577071A1 (en)
NO (1) NO20071350L (en)
WO (1) WO2006020928A2 (en)

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US8523918B2 (en) 2013-09-03
US20110029019A1 (en) 2011-02-03
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US8167947B2 (en) 2012-05-01
US8328847B2 (en) 2012-12-11
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US20060058800A1 (en) 2006-03-16
US20130013000A1 (en) 2013-01-10
ATE536822T1 (en) 2011-12-15
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US7776042B2 (en) 2010-08-17

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