US7087058B2 — Method and apparatus for providing posterior or a…

Claim 1

Independent Claim 151 words

A method of providing access for introduction of instruments to a series of adjacent vertebrae located within a human lumbar and sacral spine having an anterior aspect, a posterior aspect and an axial aspect, the vertebrae separated by intact or damaged spinal discs, the method comprising: from a skin incision, accessing an anterior or posterior sacral position of a sacral vertebra that is aligned with a visualized, trans-sacral axial fusion/instrumentation line extending in said axial aspect through the series of adjacent vertebral bodies; forming a percutaneous tract extending from the skin incision to an anterior or posterior sacral position of a sacral vertebra having a tract axis aligned with said visualized, trans-sacral axial instrumentation/fusion line providing axial guidance for said instruments introduced over or through said percutaneous tract to said anterior or posterior sacral position; and positioning an instrumentation guide in the tract, to guide the instruments to the sacral position.

Claim 2

Independent Claim 151 words

A method of providing access for introduction of instruments to a series of adjacent vertebrae located within a human lumbar and sacral spine having an anterior aspect, a posterior aspect and an axial aspect, the vertebrae separated by intact or damaged spinal discs, the method comprising: from a skin incision, accessing an anterior or posterior sacral position of a sacral vertebra that is aligned with a visualized, trans-sacral axial fusion/instrumentation line extending in said axial aspect through the series of adjacent vertebral bodies; forming a percutaneous tract extending from the skin incision to an anterior or posterior sacral position of a sacral vertebra having a tract axis aligned with said visualized, trans-sacral axial instrumentation/fusion line providing axial guidance for said instruments introduced over or through said percutaneous tract to said anterior or posterior sacral position; and positioning an instrumentation guide in the tract, to guide the instruments to the sacral position.

Claim 3

Dependent Claim 67 words

The method of claim 1 , wherein said instruments comprise a boring tool, and further comprising: from said accessed sacral position, boring a trans-sacral axial instrumentation/fusion bore through the sacrum and into at least one vertebrae and any intervertebral disc in alignment with said visualized, trans-sacral axial instrumentation/fusion line employing said boring tool advanced over or through said percutaneous tract to said anterior or posterior sacral position.

Claim 4

Dependent Claim 68 words

The method of claim 1 , wherein the step of forming a percutaneous tract further comprises forming a posterior percutaneous tract to access the posterior presacral position of a sacral vertebra in alignment with a visualized, curved, posterior axial instrumentation/fusion line extending in said axial aspect initially laterally through the sacral vertebra and then following the curvature of the spine through a series of adjacent cephalad vertebral bodies.

Claim 5

Dependent Claim 127 words

The method of claim 3 , wherein the step of forming a posterior percutaneous tract comprises: providing a posterior tract sheath having a tract sheath axis and tract sheath lumen extending between tract sheath proximal and distal ends, the tract sheath distal end formed with a bone attachment mechanism; advancing the tract sheath distal end to said posterior presacral position with said tract sheath axis aligned with a sacral end of said visualized, curved, posterior axial instrumentation/fusion line; and attaching the bone attachment mechanism at the tract sheath distal end to sacral bone to align the tract sheath axis with the sacral end of said visualized, curved, posterior axial instrumentation/fusion line, whereby the posterior tract sheath extends through the skin incision and to the posterior presacral position.

Claim 6

Dependent Claim 93 words

The method of claim 3 , wherein the accessing step further comprises: drilling a pilot hole of a first diameter from a presacral penetration position along said axial instrumentation/fusion line within and axially through said series of vertebral bodies and intervening spinal discs to a cephalad pilot hole end within a vertebral body; providing a guidewire having a guidewire proximal end and a guidewire distal end; and extending the guidewire through said presacral space and through said pilot hole to locate the distal end of said guidewire at the cephalad pilot hole end.

Claim 7

Dependent Claim 44 words

The method of claim 5 , wherein the guidewire distal end is fitted with a distal fixation mechanism, and the extending step further comprises: attaching the distal fixation mechanism of the guidewire distal end to the vertebral body at the cephalad pilot hole end.

Claim 8

Dependent Claim 63 words

The method of claim 3 , wherein the step of forming a posterior percutaneous tract comprises: providing a guidewire having a guidewire proximal end and a guidewire distal end fitted with a distal fixation mechanism; attaching the distal fixation mechanism of the guidewire distal end to the sacral bone at the sacral position; and axially aligning the guidewire with the axial instrumentation/fusion line.

Claim 9

Independent Claim 129 words

A method of providing access to a series of adjacent vertebrae located within a human lumbar and sacral spine having an anterior aspect, a posterior aspect and an axial aspect, the vertebrae separated by intact or damaged spinal discs, the method comprising: from a skin incision, accessing an anterior or posterior sacral position of a sacral vertebra that is aligned with a visualized, trans-sacral axial fusion/instrumentation line extending in said axial aspect through the series of adjacent vertebral bodies; forming an anterior, presacral, percutaneous tract through the patient's presacral space to access an anterior presacral position of a sacral vertebra in alignment with a visualized, anterior axial instrumentation/fusion line extending in said axial aspect through the series of adjacent vertebral bodies; and positioning a tubular sleeve in the tract.

Claim 10

Independent Claim 129 words

A method of providing access to a series of adjacent vertebrae located within a human lumbar and sacral spine having an anterior aspect, a posterior aspect and an axial aspect, the vertebrae separated by intact or damaged spinal discs, the method comprising: from a skin incision, accessing an anterior or posterior sacral position of a sacral vertebra that is aligned with a visualized, trans-sacral axial fusion/instrumentation line extending in said axial aspect through the series of adjacent vertebral bodies; forming an anterior, presacral, percutaneous tract through the patient's presacral space to access an anterior presacral position of a sacral vertebra in alignment with a visualized, anterior axial instrumentation/fusion line extending in said axial aspect through the series of adjacent vertebral bodies; and positioning a tubular sleeve in the tract.

Claim 11

Dependent Claim 109 words

The method of claim 8 , wherein the accessing step further comprises: making an incision through the patient's skin adjacent to the coccyx aligned with the visualized anterior axial instrumentation/fusion line; and forming a percutaneous pathway through presacral tissues in presacral space between the skin incision and an anterior target point of the anterior sacrum aligned with the visualized anterior axial instrumentation/fusion line; and the step of forming a percutaneous tract further comprises expanding the percutaneous pathway to form the anterior, presacral, percutaneous tract through the patient's skin and presacral space aligned with the visualized anterior axial instrumentation/fusion line to provide working space and exposure of the anterior sacrum.

Claim 12

Dependent Claim 87 words

The method of claim 8 , wherein the accessing step further comprises: providing a blunted tip tubular member having a tubular member body and blunt tubular member tip; and inserting the blunted tip tubular member through the incision and advancing the blunt tubular member tip along the anterior surface of the sacrum under visualization until the tubular member tip is at an anterior target point of a selected sacral vertebrae and the tubular member body is aligned with the visualized anterior axial instrumentation/fusion line and extends percutaneously.

Claim 13

Dependent Claim 244 words

The method of claim 8 , wherein the accessing step further comprises: providing a blunted tip tubular member having a tubular member lumen within a tubular member body extending from a proximal tubular member end to a distal tubular member end and a blunt tipped occluder fitted into the tubular member to extend distally from the distal tubular member end; and inserting the blunted tip tubular member through the incision and advancing the blunt tubular member tip along the anterior surface of the sacrum under visualization until the tubular member tip is at an anterior target point of a selected sacral vertebrae and the tubular member body is aligned with the visualized anterior axial instrumentation/fusion line and extends percutaneously; and the step of forming the anterior, presacral, percutaneous tract further comprises: removing the blunt tipped occluder from the tubular member lumen; providing a guidewire having a guidewire body extending between a guidewire proximal end and a guidewire distal end and a guidewire fixation mechanism for penetrating and affixing to bone at the guidewire distal end; extending the guidewire through said tubular member lumen to locate the guidewire distal end at the anterior target point; affixing the guidewire fixation mechanism to bone at the anterior target point; and removing the tubular member body, whereby the guidewire provides a percutaneous tract over or through the tubular member from the incision site to the anterior target point and aligned axially with said visualized anterior axial instrumentation/fusion line.

Claim 14

Dependent Claim 80 words

The method of claim 11 , further comprising: dilating the tissue surrounding the guidewire body; providing an enlarged diameter anterior tract sheath having a tract sheath lumen extending between proximal and distal anterior tract sheath ends; and inserting said anterior tract sheath through said enlarged anterior tissue tract over said guidewire to position said enlarged diameter anterior tract sheath distal end against the anterior sacrum with the anterior tract sheath lumen aligned axially with the visualized anterior axial instrumentation/fusion line.

Claim 15

Dependent Claim 157 words

The method of claim 11 , further comprising: providing a dilatation balloon catheter; providing an enlarged diameter anterior tract sheath having a tract sheath lumen extending between proximal and distal anterior tract sheath ends; with the guidewire aligned with the anterior axial instrumentation/fusion line, advancing the dilatation balloon catheter over the guidewire to locate a deflated balloon of the dilatation balloon catheter extending through presacral space; expanding the deflated balloon to an expanded balloon diameter to dilate the presacral tissue between the anterior sacral surface and the skin incision; advancing the enlarged diameter anterior tract sheath lumen over the expanded balloon to position the anterior tract sheath between the anterior target point and the skin incision and in alignment with the anterior axial instrumentation/fusion line; and deflating the balloon and withdrawing the balloon catheter from the anterior tract sheath lumen, whereby the anterior tract sheath lumen provides the anterior, presacral, percutaneous tract through the patient's presacral space.

Claim 16

Dependent Claim 75 words

The method of claim 11 , further comprising: providing a tissue dilator having a dilator body of a dilation diameter and a dilator lumen having a dilator lumen diameter sized to receive the guidewire and extending between proximal and distal dilator body ends; passing the dilator over the guidewire toward the anterior target point to dilate the tissue surrounding the guidewire body; and withdrawing the tissue dilator from the guidewire body upon completion of dilation.

Claim 17

Dependent Claim 70 words

The method of claim 14 , further comprising: providing an enlarged diameter anterior tract sheath having a tract sheath lumen extending between proximal and distal anterior tract sheath ends; and inserting said anterior tract sheath through said enlarged anterior tissue tract to position said enlarged diameter anterior tract sheath distal end against the anterior sacrum with the anterior tract sheath lumen aligned axially with the visualized anterior axial instrumentation/fusion line.

Claim 18

Dependent Claim 150 words

The method of claim 11 , further comprising: providing a first tissue dilator having a dilator body of a dilation diameter and a dilator lumen having a dilator lumen diameter sized to receive the guidewire and extending between proximal and distal first tissue dilator body ends; providing a second tissue dilator having a dilator body of a dilation diameter and a dilator lumen having a dilator lumen diameter sized to receive the first tissue dilator body and extending between proximal and distal second tissue dilator body ends; passing the first tissue dilator over the guidewire toward the anterior target point to dilate the tissue surrounding the guidewire body; passing the second tissue dilator over first tissue dilator and the guidewire toward the anterior target point to further dilate the tissue surrounding the guidewire body; and withdrawing the first and second tissue dilators from the guidewire body upon completion of dilation.

Claim 19

Dependent Claim 70 words

The method of claim 16 , further comprising: providing an enlarged diameter anterior tract sheath having a tract sheath lumen extending between proximal and distal anterior tract sheath ends; and inserting said anterior tract sheath through said enlarged anterior tissue tract to position said enlarged diameter anterior tract sheath distal end against the anterior sacrum with the anterior tract sheath lumen aligned axially with the visualized anterior axial instrumentation/fusion line.

Claim 20

Dependent Claim 128 words

The method of claim 11 , further comprising: providing an enlarged diameter tubular anterior tract sheath having a tract sheath lumen extending between proximal and distal anterior tract sheath ends and an anterior tract sheath distal fixation mechanism adapted to attach said enlarged diameter anterior tract sheath to sacral bone; inserting said enlarged diameter anterior tract sheath through said enlarged anterior tissue tract over said guidewire to position said enlarged diameter anterior tract sheath distal end against the anterior sacrum with the anterior tract sheath lumen aligned axially with the visualized anterior axial instrumentation/fusion line; and operating said anterior tract sheath distal fixation mechanism to attach said anterior tract sheath to sacral bone with the anterior tract sheath lumen aligned axially with the visualized anterior axial instrumentation/fusion line.

Claim 21

Dependent Claim 74 words

The method of claim 18 , wherein the anterior tract sheath fixation mechanism comprises distal screw threads encircling the distal anterior tract sheath end adapted to be screwed into bone, and the step of affixing the anterior tract sheath distal fixation mechanism to bone at the anterior target point comprises rotating the anterior tract sheath body in a proximal section extending from the skin incision to screw the distal screw threads into sacral bone.

Claim 22

Dependent Claim 136 words

A surgical operating system for farming a percutaneous pathway from a skin incision generally axially aligned with a series of adjacent vertebrae located within a human lumbar and sacral spine having an anterior aspect, a posterior aspect and an axial aspect, the vertebrae separated by intact or damaged spinal discs, the system comprising: guide means operable from a skin incision for accessing an anterior or posterior sacral position of a sacral vertebra that is aligned with a visualized, trans-sacral axial instrumentation/fusion line extending in said axial aspect through the series of adjacent vertebral bodies; and tract means defining a percutaneous tract having a tract axis aligned with said visualized, trans-sacral axial instrumentation/fusion line and extending from the skin incision to the accessed sacral position to facilitate surgical procedures aligned with said visualized, trans-sacral axial instrumentation/fusion line.

Claim 23

Dependent Claim 136 words

A surgical operating system for farming a percutaneous pathway from a skin incision generally axially aligned with a series of adjacent vertebrae located within a human lumbar and sacral spine having an anterior aspect, a posterior aspect and an axial aspect, the vertebrae separated by intact or damaged spinal discs, the system comprising: guide means operable from a skin incision for accessing an anterior or posterior sacral position of a sacral vertebra that is aligned with a visualized, trans-sacral axial instrumentation/fusion line extending in said axial aspect through the series of adjacent vertebral bodies; and tract means defining a percutaneous tract having a tract axis aligned with said visualized, trans-sacral axial instrumentation/fusion line and extending from the skin incision to the accessed sacral position to facilitate surgical procedures aligned with said visualized, trans-sacral axial instrumentation/fusion line.

Claim 24

Dependent Claim 124 words

A surgical operating system for forming a percutaneous pathway from a skin incision generally axially aligned with a series of adjacent vertebrae located within a human lumbar and sacral spine having an anterior aspect, a posterior aspect and an axial aspect, the vertebrae separated by intact or damaged spinal discs, the system comprising: an elongated guide assembly extendible from a skin incision for accessing an anterior or posterior sacral position of a sacral vertebra that is aligned with a visualized, trans-sacral axial instrumentation/fusion line extending in said axial aspect through the series of adjacent vertebral bodies; and a dilator adapted to dilate tissue surrounding the elongated guide assembly to form an enlarged percutaneous tract that is aligned with a visualized, trans-sacral axial instrumentation/fusion line.

Claim 25

Dependent Claim 124 words

A surgical operating system for forming a percutaneous pathway from a skin incision generally axially aligned with a series of adjacent vertebrae located within a human lumbar and sacral spine having an anterior aspect, a posterior aspect and an axial aspect, the vertebrae separated by intact or damaged spinal discs, the system comprising: an elongated guide assembly extendible from a skin incision for accessing an anterior or posterior sacral position of a sacral vertebra that is aligned with a visualized, trans-sacral axial instrumentation/fusion line extending in said axial aspect through the series of adjacent vertebral bodies; and a dilator adapted to dilate tissue surrounding the elongated guide assembly to form an enlarged percutaneous tract that is aligned with a visualized, trans-sacral axial instrumentation/fusion line.

Claim 26

Dependent Claim 58 words

The system of claim 21 , wherein said elongated guide assembly further comprises: an elongated tubular member enclosing a tubular member lumen extending between a tubular member proximal end and a tubular member distal end; and an occluder extending between an occluder proximal end and an occluder distal end adapted to be extended through said tubular member lumen.

Claim 27

Dependent Claim 58 words

The system of claim 21 , further comprising a tract sheath adapted to be fitted over said elongated guide assembly following dilation of tissue, the tract sheath having a tract sheath lumen forming the percutaneous tract having a tract axis aligned with said visualized, trans-sacral axial instrumentation/fusion line extending from the skin incision to the accessed sacral position.

Claim 28

Dependent Claim 166 words

Apparatus for obtaining access to and through a series of adjacent vertebrae located within a human lumbar and sacral spine having an anterior aspect, a posterior aspect and an axial aspect, the vertebrae separated by intact or damaged spinal discs, the apparatus comprising: means for exposing a sacral position of a sacral vertebra in alignment with a visualized, trans-sacral axial instrumentation/fusion line extending in said axial aspect through the series of adjacent vertebral bodies; means operable from the exposed sacral position for boring a trans-sacral pilot hole extending along said axial instrumentation/fusion line cephalad and axially through the vertebral bodies of said series of adjacent vertebrae and any intervening spinal discs to a pilot hole cephalad end; and a guidewire having a guidewire body extending between a guidewire proximal end and a guidewire distal end having a guidewire fixation mechanism at the guidewire distal end adapted to be advanced into the pilot hole and affixed to vertebral bone at the cephalad end of the pilot hole.

Claim 29

Dependent Claim 166 words

Apparatus for obtaining access to and through a series of adjacent vertebrae located within a human lumbar and sacral spine having an anterior aspect, a posterior aspect and an axial aspect, the vertebrae separated by intact or damaged spinal discs, the apparatus comprising: means for exposing a sacral position of a sacral vertebra in alignment with a visualized, trans-sacral axial instrumentation/fusion line extending in said axial aspect through the series of adjacent vertebral bodies; means operable from the exposed sacral position for boring a trans-sacral pilot hole extending along said axial instrumentation/fusion line cephalad and axially through the vertebral bodies of said series of adjacent vertebrae and any intervening spinal discs to a pilot hole cephalad end; and a guidewire having a guidewire body extending between a guidewire proximal end and a guidewire distal end having a guidewire fixation mechanism at the guidewire distal end adapted to be advanced into the pilot hole and affixed to vertebral bone at the cephalad end of the pilot hole.

Claim 30

Dependent Claim 185 words

A surgical operating system for forming a percutaneous pathway from a skin incision generally axially aligned with a series of adjacent vertebrae located within a human lumbar and sacral spine having an anterior aspect, a posterior aspect and an axial aspect, the vertebrae separated by intact or damaged spinal discs, the system comprising: guide means operable from a skin incision through a patient's skin and exposing a posterior, presacral position of a sacral vertebra in alignment with a visualized, curved, posterior axial instrumentation/fusion line extending in said axial aspect initially laterally through the sacral vertebra and then following the curvature of the spine through a series of adjacent cephalad vertebral bodies for accessing a posterior sacral position of a sacral vertebra that is aligned with the visualized, trans-sacral axial instrumentation/fusion line extending in said axial aspect through the series of adjacent vertebral bodies; and tract means defining a percutaneous tract having a tract axis aligned with said visualized, trans-sacral axial instrumentation/fusion line and extending from the skin incision to the accessed sacral position to facilitate surgical procedures aligned with said visualized, trans-sacral axial instrumentation/fusion line.

Claim 31

Dependent Claim 185 words

A surgical operating system for forming a percutaneous pathway from a skin incision generally axially aligned with a series of adjacent vertebrae located within a human lumbar and sacral spine having an anterior aspect, a posterior aspect and an axial aspect, the vertebrae separated by intact or damaged spinal discs, the system comprising: guide means operable from a skin incision through a patient's skin and exposing a posterior, presacral position of a sacral vertebra in alignment with a visualized, curved, posterior axial instrumentation/fusion line extending in said axial aspect initially laterally through the sacral vertebra and then following the curvature of the spine through a series of adjacent cephalad vertebral bodies for accessing a posterior sacral position of a sacral vertebra that is aligned with the visualized, trans-sacral axial instrumentation/fusion line extending in said axial aspect through the series of adjacent vertebral bodies; and tract means defining a percutaneous tract having a tract axis aligned with said visualized, trans-sacral axial instrumentation/fusion line and extending from the skin incision to the accessed sacral position to facilitate surgical procedures aligned with said visualized, trans-sacral axial instrumentation/fusion line.

Claim 32

Dependent Claim 88 words

The system of claim 25 , wherein the tract means comprises a tubular posterior tract sheath forming a posterior percutaneous tract through the patient's presacral space to access the posterior presacral position of a sacral vertebra in alignment with the visualized, anterior axial instrumentation/fusion line extending in said axial aspect through the series of adjacent vertebral bodies to enable boring a curved posterior axial bore extending along said posterior axial instrumentation/fusion line cephalad through the vertebral bodies of said series of adjacent vertebrae and any intervening spinal discs.

Claim 33

Dependent Claim 61 words

The system of claim 26 , wherein the tubular posterior tract sheath has a tract sheath lumen extending between proximal and distal posterior tract sheath ends and a posterior tract sheath distal fixation mechanism adapted to attach said posterior tract sheath distal end to sacral bone with the posterior tract sheath lumen aligned axially with the visualized posterior axial instrumentation/fusion line.

Claim 34

Independent Claim 221 words

A method of providing access to a series of adjacent vertebrae located within a lumbar and sacral spine having an anterior aspect, a posterior aspect and an axial aspect, the vertebrae separated by intact or damaged spinal discs, the method comprising: making an incision through the patient's dermal entry site aligned with a visualized curved, posterior axial instrumentation/fusion line extending in said axial aspect through the series of adjacent vertebral bodies; providing a guide assembly having a guide assembly body extending between guide assembly proximal and distal ends, said guide assembly comprising a guide tubular member having a tubular member lumen within a tubular member body extending between proximal and distal tubular member ends; advancing the guide assembly through the incision to locate the guide assembly distal end against the posterior surface of the sacrum; further advancing the guide assembly distal end under visualization until the guide assembly distal end is at a posterior target point of a selected sacral vertebrae and the guide assembly body is aligned with the visualized curved, posterior axial instrumentation/fusion line and extends percutaneously to the guide assembly proximal end; and advancing the tubular member distal end against the posterior target point, whereby the tubular member provides a percutaneous tract over or through the tubular member from the dermal entry site to the posterior target paint.

Claim 35

Independent Claim 221 words

A method of providing access to a series of adjacent vertebrae located within a lumbar and sacral spine having an anterior aspect, a posterior aspect and an axial aspect, the vertebrae separated by intact or damaged spinal discs, the method comprising: making an incision through the patient's dermal entry site aligned with a visualized curved, posterior axial instrumentation/fusion line extending in said axial aspect through the series of adjacent vertebral bodies; providing a guide assembly having a guide assembly body extending between guide assembly proximal and distal ends, said guide assembly comprising a guide tubular member having a tubular member lumen within a tubular member body extending between proximal and distal tubular member ends; advancing the guide assembly through the incision to locate the guide assembly distal end against the posterior surface of the sacrum; further advancing the guide assembly distal end under visualization until the guide assembly distal end is at a posterior target point of a selected sacral vertebrae and the guide assembly body is aligned with the visualized curved, posterior axial instrumentation/fusion line and extends percutaneously to the guide assembly proximal end; and advancing the tubular member distal end against the posterior target point, whereby the tubular member provides a percutaneous tract over or through the tubular member from the dermal entry site to the posterior target paint.

Claim 36

Dependent Claim 24 words

The method of claim 28 , further comprising the step of determining the dermal entry site by mapping the curved, posterior axial instrumentation/fusion line.

Claim 37

Dependent Claim 22 words

The method of claim 29 , wherein the step of mapping the curved, posterior axial instrumentation/fusion line comprises performing a CT scan.

Claim 38

Dependent Claim 22 words

The method of claim 29 , wherein the step of mapping the curved, posterior axial instrumentation/fusion line comprises performing a MRI study.

Claim 39

Dependent Claim 21 words

The method of claim 28 , further comprising the step of performing a laminectomy at the posterior surface of the sacrum.

Claim 40

Dependent Claim 22 words

The method of claim 32 , further comprising the step of retracting the thecal sac and nerve roots exposed by the laminectomy.

Claim 41

Dependent Claim 49 words

The method of claim 28 , wherein the step of providing a guide assembly further comprises providing a beveled tip tubular member having a tubular member lumen within a tubular member body extending from a proximal tubular member end to a distal tubular member end as said tubular member.

Claim 42

Dependent Claim 49 words

The method of claim 28 , wherein the step of providing a guide assembly further comprises providing a blunt tip tubular member having a tubular member lumen within a tubular member body extending from a proximal tubular member end to a distal tubular member end of said tubular member.

Claim 43

Dependent Claim 42 words

The method of claim 28 , wherein the step of providing a guide assembly further comprises providing a trocar having a trocar lumen within a trocar body extending from a proximal trocar end to a distal trocar end of said tubular member.

Claim 44

Dependent Claim 47 words

The method of claim 28 , wherein the step of providing a guide assembly further comprises providing a guide sheath having a guide sheath lumen within a guide sheath body extending from a proximal guide sheath end to a distal guide sheath end of said tubular member.

Claim 45

Independent Claim 307 words

A method of providing access to a series of adjacent vertebrae located within a lumbar and sacral spine having an anterior aspect, a posterior aspect and an axial aspect, the vertebrae separated by intact or damaged spinal discs, the method comprising: making an incision through the patient's dermal entry site aligned with a visualized curved, posterior axial instrumentation/fusion line extending in said axial aspect through the series of adjacent vertebral bodies; providing a guide assembly having a guide assembly body extending between guide assembly proximal and distal ends, said guide assembly comprising: a guide tubular member having a tubular member lumen within a tubular member body extending between proximal and distal tubular member ends; and a guidewire having a guidewire body extending between a guidewire proximal end and a guidewire distal end having a guidewire fixation mechanism for penetrating and affixing to bone at the guidewire distal end; inserting the guidewire through said tubular member lumen to locate the guidewire distal end retracted within said tubular member lumen and said guidewire proximal end extending proximally from said tubular member proximal end; advancing the guide assembly through the incision to located the guide assembly distal end against the posterior surface of the sacrum; further advancing the guide assembly distal end under visualization until the guide assembly distal end is at a posterior target point of a selected sacral vertebrae and the guide assembly body is aligned with the visualized curved, posterior axial instrumentation/fusion line and extends percutaneously to the guide assembly proximal end; extending the guidewire through said tubular member lumen into contact with the sacrum; affixing the guidewire fixation mechanism to sacral bone at the posterior target point; and removing the tubular member, whereby the attached guidewire provides a percutaneous tract for over the wire passage extending from the dermal entry site to the posterior target point.

Claim 46

Independent Claim 307 words

A method of providing access to a series of adjacent vertebrae located within a lumbar and sacral spine having an anterior aspect, a posterior aspect and an axial aspect, the vertebrae separated by intact or damaged spinal discs, the method comprising: making an incision through the patient's dermal entry site aligned with a visualized curved, posterior axial instrumentation/fusion line extending in said axial aspect through the series of adjacent vertebral bodies; providing a guide assembly having a guide assembly body extending between guide assembly proximal and distal ends, said guide assembly comprising: a guide tubular member having a tubular member lumen within a tubular member body extending between proximal and distal tubular member ends; and a guidewire having a guidewire body extending between a guidewire proximal end and a guidewire distal end having a guidewire fixation mechanism for penetrating and affixing to bone at the guidewire distal end; inserting the guidewire through said tubular member lumen to locate the guidewire distal end retracted within said tubular member lumen and said guidewire proximal end extending proximally from said tubular member proximal end; advancing the guide assembly through the incision to located the guide assembly distal end against the posterior surface of the sacrum; further advancing the guide assembly distal end under visualization until the guide assembly distal end is at a posterior target point of a selected sacral vertebrae and the guide assembly body is aligned with the visualized curved, posterior axial instrumentation/fusion line and extends percutaneously to the guide assembly proximal end; extending the guidewire through said tubular member lumen into contact with the sacrum; affixing the guidewire fixation mechanism to sacral bone at the posterior target point; and removing the tubular member, whereby the attached guidewire provides a percutaneous tract for over the wire passage extending from the dermal entry site to the posterior target point.

Claim 47

Dependent Claim 24 words

The method of claim 38 , further comprising the step of determining the dermal entry site by mapping the curved, posterior axial instrumentation/fusion line.

Claim 48

Dependent Claim 22 words

The method of claim 39 , wherein the step of mapping the curved, posterior axial instrumentation/fusion line comprises performing a CT scan.

Claim 49

Dependent Claim 22 words

The method of claim 39 , wherein the step of mapping the curved, posterior axial instrumentation/fusion line comprises performing a MRI study.

Claim 50

Dependent Claim 48 words

The method of claim 38 , wherein the step of providing a guide assembly further comprises providing a blunt tip tubular member having a tubular member lumen within a tubular member body extending from a proximal tubular member end to a distal tubular member as said tubular member.

Claim 51

Dependent Claim 42 words

The method of claim 38 , wherein the step of providing a guide assembly further comprises providing a trocar having a trocar lumen within a trocar body extending from a proximal trocar end to a distal trocar end as said tubular member.

Claim 52

Dependent Claim 47 words

The method of claim 38 , wherein the step of providing a guide assembly further comprises providing a guide sheath having a guide sheath lumen within a guide sheath body extending from a proximal guide sheath end to a distal guide sheath end as said tubular member.

Claim 53

Dependent Claim 23 words

The method of claim 38 , wherein the guidewire fixation mechanism comprises a distal screw-in tip adapted to be screwed into sacral bone.

Claim 54

Dependent Claim 23 words

The method of claim 38 , wherein the guidewire fixation mechanism comprises a distal sharpened tip adapted to be pushed into sacral bone.

Claim 55

Dependent Claim 65 words

The method of claim 38 , further comprising: dilating the tissue surrounding the guidewire body; providing an enlarged diameter posterior tract sheath having a tract sheath lumen extending between proximal and distal posterior tract sheath ends; and inserting said posterior tract sheath through said enlarged posterior tissue tract over said guidewire to position said enlarged diameter posterior tract sheath distal end against the posterior sacrum.

Claim 56

Dependent Claim 51 words

The method of claim 47 , wherein the step of dilating the tissue further comprises: providing a dilation balloon catheter having a balloon in the deflated state; and expanding the deflated balloon to an expanded state to dilate the presacral tissue between the posterior sacral surface and the dermal entry site.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2009-08-07	2010-02-06	2010-08-08	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2013-08-07	2014-02-06	2014-08-08	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2017-08-07	2018-02-06	2018-08-08	$7700.00	Window Closed / Lapsed

Method and apparatus for providing posterior or anterior trans-sacral access to spinal vertebrae

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