U.S. patent application number 17/364906 was filed with the patent office on 2021-10-21 for method and implant system for sacroiliac joint fixation and fusion.
The applicant listed for this patent is Orthocision Inc.. Invention is credited to Steve Anderson, Troy Schifano, Teck-Mun Soo, Gowriharan Thaiyananthan.
Application Number | 20210322077 17/364906 |
Document ID | / |
Family ID | 1000005695581 |
Filed Date | 2021-10-21 |
United States Patent
Application |
20210322077 |
Kind Code |
A1 |
Schifano; Troy ; et
al. |
October 21, 2021 |
METHOD AND IMPLANT SYSTEM FOR SACROILIAC JOINT FIXATION AND
FUSION
Abstract
An improved method of fusing the sacroiliac joint and tools for
accomplishing the same is disclosed. In one embodiment, the present
invention is a method that uses an intra-articular joint fusion
device for connecting the sacrum and ilium that includes creating a
first incision in the patient's skin proximal to the patient's
sacroiliac joint, inserting a surgical channel tool into the
incision from the patient's posterior, creating a void in the
sacroiliac joint, inserting a fusion implant into the void, the
fusion implant having at least one fixation element for engagement
with bone tissue in the articular surfaces of the sacrum and the
ilium, and driving the fusion implant into the void such that the
at least one fixation element engages with bone tissue in an
articular surface of at least one of the sacrum and ilium, and the
fusion implant fixes relative positions of the sacrum and
ilium.
Inventors: |
Schifano; Troy; (Morgantown,
WV) ; Anderson; Steve; (Folsom, CA) ; Soo;
Teck-Mun; (Southfield, MI) ; Thaiyananthan;
Gowriharan; (Irvine, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Orthocision Inc. |
Folsom |
CA |
US |
|
|
Family ID: |
1000005695581 |
Appl. No.: |
17/364906 |
Filed: |
July 1, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16718189 |
Dec 18, 2019 |
11083511 |
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17364906 |
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14668976 |
Mar 25, 2015 |
10993757 |
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16718189 |
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13842227 |
Mar 15, 2013 |
9119732 |
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14668976 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/1671 20130101;
A61B 17/8872 20130101; A61F 2002/30904 20130101; A61B 17/8605
20130101; A61B 17/869 20130101; A61B 17/7055 20130101; A61B 17/1757
20130101; A61F 2/4455 20130101; A61F 2002/30828 20130101; A61F
2002/30995 20130101; A61F 2/447 20130101; A61F 2/4611 20130101;
A61F 2002/30785 20130101 |
International
Class: |
A61B 17/88 20060101
A61B017/88; A61F 2/46 20060101 A61F002/46; A61B 17/17 20060101
A61B017/17; A61F 2/44 20060101 A61F002/44; A61B 17/86 20060101
A61B017/86; A61B 17/70 20060101 A61B017/70 |
Claims
1-31. (canceled)
32. A kit for repairing a sacroiliac joint of a patient,
comprising: a. a cannula having a working channel and at least one
tang on a distal end thereof operable to be inserted between a
sacrum and an ilium of said sacroiliac joint b. a fusion implant
having at least one protrusion for engagement with bone tissue in
an articular surface of at least one of an ilium and a sacrum in
said sacroiliac joint and is operable to prevent dislodgement of
said fusion implant.
33. (canceled)
34. (canceled)
35. The kit of claim 32, further comprising an impactor operable to
be passed through said working channel, wherein said impactor is
operable to drive said fusion implant into said sacroiliac joint
such that said at least one protrusion engages with tissue of at
least one of said ilium and said sacrum.
36. The kit of claim 32, wherein said fusion implant has a central
body and said at least one protrusion extends from said central
body and is operable to fix relative positions of said ilium and
sacrum with engagement of said at least one protrusion with said
ilium and sacrum when said fusion implant is inserted between said
ilium and said sacrum.
37. The kit of claim 36, wherein said cannula includes a guidance
slot within the working channel that does not traverse the outer
diameter of said hollow barrel for controlling the advancement of
surgical tools passed through said working channel.
38. (canceled)
39. (canceled)
40. The kit of claim 32, wherein said fusion implant contacts the
ilium and the sacrum and compresses the articular surfaces of the
ilium and the sacrum together, and thereby securing said implant in
said sacroiliac joint.
41. (canceled)
42. (canceled)
43. The kit of claim 32, wherein said fusion implant comprises a
cavity for holding a fusion-promoting material, said cavity
comprising at least one gap or hole therein for allowing the growth
of bone tissue into said cavity.
44. (canceled)
45. (canceled)
46. (canceled)
47. The kit of claim 37, further comprising a fusion implant
inserter, wherein the inserter has a distal end configured to
attach to lateral grooves in said fusion implant and includes a
portion operable to engage with said guidance slot within said
working channel.
48. (canceled)
49. A system for repairing a sacroiliac joint of a patient,
comprising: a. a cannula having a working channel operable to be
inserted into an incision proximal to a patient's sacroiliac joint;
b. a guidance slot within the working channel for controlling the
advancement of surgical tools passed through said working channel;
and c. a fusion implant having at least one protrusion for engaging
with bone tissue within said sacroiliac joint and said fusion
implant is operable to fix relative positions of said sacrum and
said ilium when inserted into said sacroiliac joint.
50. (canceled)
51. (canceled)
52. (canceled)
53. (canceled)
54. (canceled)
55. (canceled)
56. The system of claim 49, wherein a proximal end of an elongate
body of said fusion implant includes at least one groove in a
surface thereof for engagement with an inserter tool for
positioning said fusion implant into said sacroiliac joint.
57. (canceled)
58. (canceled)
59. (canceled)
60. (canceled)
61. (canceled)
62. (canceled)
63. (canceled)
64. (canceled)
65. (canceled)
66. (canceled)
67. The system of claim 56, wherein a. the inserter tool has a
distal end configured to attach to the groove of said fusion
implant; and b. said inserter has a guidance protrusion operable to
be inserted into a stop slot within said working channel, wherein
said stop slot controls the advancement of the inserter through
said working channel.
68. The method of claim 49, wherein driving said fusion implant
into said void comprises rotating said fusion implant or a portion
thereof having said at least one fixation element thereon.
69. (canceled)
70. (canceled)
71. (canceled)
72. (canceled)
73. (canceled)
74. (canceled)
75. (canceled)
76. (canceled)
77. The kit of claim 32, further comprising a fusion implant
inserter having a plurality of implant engagement arms operable to
engage with slots on sides of said fusion implant.
78. The method of claim 49, wherein said cannula includes at least
one tang protruding from a distal end thereof for securing a
position of said cannula in said sacroiliac joint.
79. The method of claim 32, wherein said at least one protrusion is
a helical anchor operable to penetrate bone tissue in said
sacroiliac joint.
80. A kit for repairing a sacroiliac joint of a patient,
comprising: a. a cannula having working channel including at least
one tang protruding from a distal end of the working channel for
securing a position of said cannula in said sacroiliac joint; b. a
fusion implant having a plurality of fixation elements for
engagement with bone tissue of an articular surface of at least one
of the sacrum and the ilium of said sacroiliac joint, said fusion
implant being operable to fix relative positions of said sacrum and
said ilium.
81. The method of claim 80, wherein said at least one fixation
element comprises a helical anchor having a sharp end for piercing
said bone tissue, and said helical anchor first penetrates said
articular surface of said at least one of said sacrum and said
ilium.
82. The kit of claim 81, wherein said at least one fixation element
is operable to penetrate bone tissue in said articular surface of
at least one of said ilium and said sacrum when said fusion implant
is rotated.
83. The kit of claim 80, further comprising: a. a fusion implant
inserter, wherein the inserter has a distal end configured to
attach to at least one groove in the fusion implant; and b. a
guidance slot within said working channel for controlling the
advancement of surgical tools through said working channel, wherein
said inserter includes a protrusion operable to be inserted in said
guidance slot when the inserter is introduced into said working
channel.
84. The kit of claim 80, wherein said fusion implant is operable to
immobilize and fuse said sacroiliac joint without further implants
or fusion devices introduced into the sacroiliac joint or
surrounding tissues.
85. The kit of claim 81, wherein said fusion implant contacts the
ilium and the sacrum and compresses the articular surfaces of said
sacroiliac joint together, and thereby securing said fusion implant
in said sacroiliac joint.
86. The kit of claim 80, wherein said working channel includes a
plurality of tangs protruding from a distal end of the working
channel for securing a position of said working channel in said
sacroiliac joint.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to medical devices
and medical methods. More particularly, the present invention
relates to musculoskeletal surgical methods and associated surgical
tools for treatment of the sacroiliac joint.
DISCUSSION OF THE BACKGROUND
[0002] Lower back pain is a common ailment among the population and
results in both pain and suffering as well as loss of work time.
Thus, approaches for the treatment of back pain can both relieve
suffering as well as reduce employee down time. Thus, effective
treatments for lower back pain have both economic benefits as well
as the benefit of alleviating considerable suffering.
[0003] The sacroiliac joint is located in the lower back at the
juncture of the ilium, the upper bone of the pelvis, and the sacrum
at the base of the spine. While the sacroiliac joint has a limited
range of motion, dysfunction of the joint has been identified. The
joint is supported by a range of ligaments including, for example,
the sacroiliac ligament at the base of the joint and the anterior
sacroiliac ligament at the top of the joint.
[0004] The sacroiliac joint (SI joint) is increasingly being
diagnosed as a common pain generator. That is, SI joint
degenerative disease and instability are being diagnosed and
treated more commonly. Sacroiliac pain may be caused by a
disruption in the joint itself, a biomechanical problem like a
muscle imbalance, trauma, an inflammatory condition like ankylosing
spondylitis, or a degenerative problem as seen with post-lumbar
fusion adjacent segment disorder. Other contributing factors
include post pregnancy pain/instability, longer life span, and/or
more active lifestyles. In addition, complex spine surgeries, such
as for correction of sagittal plane deformity, often require iliac
fixation to maintain correction in patients with a high pelvic
incidence or high risk of lumbo-sacral hardware failure.
[0005] High energy pelvic ring injuries that involve disruption of
the SI joint and/or displaced fractures of the sacrum present
unique challenges to the orthopedic traumatologist. Some sacral
fractures require solid posterior stabilization, which may be
difficult to achieve with typical treatment methods. Furthermore,
vertically unstable sacral fractures/SI joint disruptions have a
relatively high incidence of neurovascular injury and may require
unique stabilization. Typically, a spinal surgeon will be involved
to perform lumbo-pelvic stabilization of these injuries to provide
vertical stability of the injury. However, there may be significant
soft tissue trauma associated with these injuries, making extensive
surgical approaches of elevated risk in terms of infection and
wound complications.
[0006] Immobilization of the SI joint can result in significant
relief of lower back pain. Current techniques and instrumentation
systems may require extensive surgical exposure and dissection.
Moreover, such instrumentation systems are typically designed for
other applications, and not to connect and stabilize the lumbar
spine and pelvis. As a result, this can make the surgical times
longer and more frustrating for surgeons and surgical staff. For
example, traditional posterior iliac screws are often prominent
because the posterior iliac crest is relatively subcutaneous. Yet,
this sometimes makes hardware painful for the patient and at risk
for pressure soreness following surgery.
[0007] Furthermore, the current techniques and instruments do not
allow for a secure and consistent fusion construct. They may
provide one or the other many times, but not both issues. This may
lead to further SI joint instability and a failed surgery.
[0008] It is therefore desirable to provide new surgical methods
and tools for treating damaged sacroiliac joints that securely and
consistently fuse the joint.
SUMMARY OF THE INVENTION
[0009] The present invention is an improved methods and devices for
the immobilization or fusion of the Sacroiliac joint and
apparatuses for facilitating the procedure. Immobilization may
refer to mechanical holding or surgical fusion.
[0010] The present invention provides a system and surgical tools
for introducing fusion implants that may perform the functions of
mechanical fixation and stability, compression, and bony fusion.
The present invention also relates to improved implant devices that
may perform the functions of mechanical fixation and stability,
compression, and bony fusion. The present invention also relates to
methods of introducing fusion implants into a targeted joint
through a novel exposure device. Specifically, with respect to some
embodiments, an approach is described to address the SI joint
through a posterior access approach while delivering fusion device
that includes both a cavity or channel for graft or
fusion-promoting material and fixation elements which can be in the
form of helical anchors, claw or fluke anchors, blades, screws,
and/or other fixation elements, which provide for compression
across the sacroiliac joint. In some embodiments, a double barreled
exposure device may be utilized to address the SI joint through a
posterior approach while delivering both a fusion device to the SI
joint and a separate fixation device for fixing the sacrum and
ilium together, which can be in the form of a screw, or the
like.
[0011] It is therefore an object of the present invention to
provide an improved approach for both mechanical holding and
surgical fusion through novel exposure devices described herein.
The implants described herein may be introduced through a posterior
approach to address the SI joint and the fusion device may perform
the functions of fixation, compression, and bony fusion, providing
a secure fixation element for mechanical stability and a bony
fusion element that allows for fusion between the sacrum and the
ilium.
[0012] It is also an object of the present invention to provide an
improved, combined approach for both mechanical holding and
surgical fusion using novel fusion devices that may be introduced
through a novel exposure device through a posterior approach, while
delivering a separate fixation device which can be in the form of a
screw, or the like. Furthermore, the fusion device is delivered to
the joint, placed between the sacrum and ilium, while the fixation
device is delivered through the iliac wing, closest to the iliac
crest, into the sacrum while not entering or going across the SI
joint.
[0013] It is also an object of the present invention to provide
novel fusion implants that are capable of performing perform the
functions of fixation, compression, and bony fusion, allowing for
stable fusion of the SI joint through a single posterior approach.
However, such fusion implants may be used in combination with other
devices to mechanically fix and stabilize the joint.
[0014] In some embodiments, the present invention relates to a
fusion implant, comprising an elongate body adapted for placement
in an intra-articular space between articular surfaces of a joint
in general longitudinal alignment with a plane between the
articular surfaces of the joint; at least one fixation element for
engagement with bone tissue in at least one of the articular
surfaces of the joint; and a cavity in the implant for holding a
fusion-promoting material.
[0015] In some embodiments, the present invention relates to a
medical instrument kit, including a joint fusion implant having a
central body and at least one lateral fixation element for
engagement with bone tissue in articular surfaces of a joint, and a
surgical tool having a working channel for insertion into an
incision (e.g., over a sacroiliac joint) in a human or animal, the
working channel having a hollow barrel having a shape for receiving
the joint fusion implant including the at least one lateral
fixation element. The surgical tool may include at least one tang
at the distal end thereof for insertion in a joint exposed by the
incision, where the tang is operable to secure maintain a position
of the working channel in the joint. In some implementations, and
without limitation, the hollow barrel may have an oblong
cross-sectional shape for accommodating the joint fusion implant
and allowing the at least one fixation element to pass through the
hollow barrel without obstruction, where the hollow barrel has a
substantially uniform transverse cross section having a
substantially elliptical shape and the elongate portions of the
elliptical cross-section function as channels for receiving the at
least one lateral fixation element. In some implementations, and
without limitation, the hollow barrel may have at least one lateral
slot running longitudinally along the hollow barrel to allow the at
least one fixation element to pass through the interior passage
without obstruction. In some embodiments, and without limitation,
the surgical tool may further include a second working channel that
is inserted into a second incision over an iliac wing of the human
patient adjacent to the sacroiliac joint when the working channel
is inserted into the sacroiliac joint. In some implementations, and
without limitation, the working channel and the second working
channel are connected by a connecting bar having a bend therein,
and are connected at an acute angle that allows the working channel
to be engaged with a posterior side of the sacroiliac joint and the
second working channel to be engaged with a posterior portion of
the iliac wing simultaneously. The kit may further include
additional instruments to establish the working channels in the
first and second incisions, and for introducing the fusion implant
into the SI joint and a joint fixation device (e.g., a surgical
screw) into the ilium and sacrum without traversing the SI joint,
including a drill operable to be passed through the working channel
into the incision and drilling a void through the connective
tissues in the SI joint, as well as drill bits; an inserter having
a proximal end configured to attach to the fusion implant, the
inserter being operable to pass the fusion implant through the
hollow barrel and into the joint; an impactor for driving the
fusion implant into the joint, wherein driving the fusion implant
engages the at least one fixation element with articular surfaces
in the joint; joint cutting instruments; dilators; guide wires;
guide pins; guide pin assemblies; a rasp; a box chisel; a driver
for inserting surgical screws (e.g., a flex-shaft driver);
adjustable arms for stabilizing the working channels; and other
tools that may be utilized in establishing incisions and access to
a joint or bone tissue.
[0016] In some embodiments, the present invention relates to a
method including creating an incision proximal to the patient's SI
joint, dilating the incision, engaging an exposure device with the
incision, creating a void in the SI joint, and inserting and
securing a joint fusing device in the void between the ilium and
sacrum.
[0017] In some embodiments, the present invention relates to a
method including creating an incision proximal to the patient's SI
joint, creating an incision over iliac wing, dilating the
incisions, engaging the exposure device with both incisions,
creating a void in the SI joint, inserting a graft into the void,
drilling a hole through the ilium and the S1 vertebra of the
sacrum, and inserting a joint fusing device in the ilium and
sacrum.
[0018] In some embodiments, the present invention relates to a
method for repairing a sacroiliac joint of a patient that includes
creating a first incision in the patient's skin proximal to the
patient's sacroiliac joint; inserting a first working channel into
the first incision and spreading the sacroiliac joint with an
inserted end of the first working channel; creating a void in the
sacroiliac joint; inserting a fusion implant into the void, the
fusion implant having at least one fixation element for engagement
with bone tissue in the articular surfaces of the sacrum and the
ilium in the sacroiliac joint; creating a second incision in the
patient's skin over an iliac wing of the patient adjacent to the
sacroiliac joint; inserting a second working channel into the
second incision wherein a longitudinal axis of the second working
channel does not intersect the sacroiliac joint; and inserting a
joint fixation device into the ilium and the sacrum through the
second working channel, wherein the joint fixation device does not
traverse the sacroiliac joint.
[0019] In some embodiments, the present invention relates to a
method including preparing the patient for surgery (e.g.,
positioning the patient in a prone position to provide the surgeon
access to the SI joint, general or local anesthesia, and the like),
locating the SI joint and an incision point for access to the SI
joint (e.g., by blunt finger palpation), insertion of a pin or wire
to create an incision, insertion of a dilator over the pin and
impacting the dilator to dilate the incision to a width through
which instruments may be passed, inserting a working channel of an
exposure device over the dilator, securing the working channel in
position with fixing pins, removing the dilator, inserting a drill
bit apparatus through the work channel, using the drill bit
apparatus in the working channel to displace bone in the SI joint
thereby creating a void, removing the drill bit apparatus, loading
a joint fusion device into the first working channel until the
joint fusion device is positioned proximal to the void in the
patient's SI joint, inserting an impactor into the working channel
and applying force to displace the graft into the void in the
patient's SI joint, inserting a driver into the working channel,
engaging the joint fusion device with the driver, and rotating the
driver to rotate the joint fusion device such that anchoring
devices on said joint fusion device engage with bone tissue of at
least one of the sacrum and the ilium, removing all instruments,
and closing the incision.
[0020] In some embodiments, the present invention relates to a
joint fixation method including preparing the patient for surgery
(e.g., positioning the patient in a prone position to provide the
surgeon access to the SI joint, general or local anesthesia, and
the like), locating the SI joint and an incision point for access
to the SI joint (e.g., by blunt finger palpation), insertion of a
pin or wire to create an incision, insertion of a dilator over the
pin and impacting the dilator to dilate the incision to a width
through which instruments may be passed, inserting a working
channel of an exposure device over the dilator, securing the
working channel in position with fixing pins, removing the dilator,
inserting a drill bit apparatus through the work channel, using the
drill bit apparatus in the working channel to displace bone in the
SI joint thereby creating a void, removing the drill bit apparatus,
excavating cortical bone tissue from articular surfaces within the
joint, loading a joint fusion device into the first working channel
until the joint fusion device is positioned proximal to the void in
the patient's SI joint, inserting an impactor into the working
channel and applying force to displace the joint fusion device into
the void in the patient's SI joint, removing all instruments, and
closing the incision.
[0021] In some embodiments, the present invention relates to a
method of implanting a fusion device into a sacroiliac joint of a
patient, including creating an incision in the patient's skin
proximal to the patient's sacroiliac joint; using a joint probe to
identify the sacroiliac joint; inserting a guide wire through a
canal in the joint probe and into the sacroiliac joint; slotting a
surgical channel device over the guide wire, the surgical channel
device having a working channel; creating a void in the sacroiliac
joint, wherein creating the void comprises displacing a portion of
the patient's ilium and a portion of the patient's sacrum with an
inserted end of the working channel, inserting a drill bit into the
working channel, and drilling the void into the sacroiliac joint;
inserting a fusion implant into the void, wherein the fusion
implant includes a plurality of fixation elements and is configured
to substantially compress, fix, and fuse the patient's ilium to the
patient's sacrum; and engaging the fixation elements of the fusion
implant with bone tissue in the articular surfaces of the patient's
ilium and sacrum.
[0022] In some embodiments, the present invention relates to a
method including preparing the patient for surgery (e.g.,
positioning the patient in a prone position to provide the surgeon
access to the SI joint, general or local anesthesia, and the like),
making a small incision over the top of the iliac wing from a
posterior approach, locating the SI joint and an incision point for
access to the SI joint (e.g., by blunt finger palpation), insertion
of a pin or wire to create an incision, insertion of a dilator over
the pin and impacting the dilator to dilate the incision to a width
through which instruments may be passed, inserting a first working
channel of a double-barreled, double-angled exposure device over
the dilator and inserting a second working channel of said exposure
device in the incision over the iliac wing, securing the first and
second working channels in position with fixing pins, removing the
dilator, inserting a drill bit apparatus through each of the first
and second work channels, using the drill bit apparatus in the
first working channel to displace bone in the SI joint thereby
creating a void, using the drill bit apparatus (or a second drill
bit apparatus) in the second working channel to drill a hole in the
iliac crest and the S1 vertebra of the sacrum, removing the drill
bit apparatus, loading a graft onto an inserter and inserting the
graft and inserter into the first working channel until the graft
is positioned proximal to the void in the patient's SI joint,
inserting an impactor into the first working channel and applying
force to displace the graft into the void in the patient's SI
joint, inserting a joint fusion device coupled to a fusion device
inserter into the second working channel and implanting said joint
fusion device in the hole in the iliac crest and the sacrum,
removing all instruments, and closing the incisions.
[0023] Additional objects of the invention will be apparent from
the detailed descriptions and the claims herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] FIG. 1 is an anterior view of the bony anatomy of the pelvis
and sacrum.
[0025] FIG. 2 is a posterior view of the bony anatomy of the pelvis
and sacrum.
[0026] FIG. 3 is a right lateral view of the bony anatomy of the
pelvis and sacrum.
[0027] FIG. 4 is a left lateral view of the bony anatomy of the
pelvis and sacrum.
[0028] FIG. 5 is a superior view of the bony anatomy of the pelvis
and sacrum.
[0029] FIG. 6 is an inferior view of the bony anatomy of the pelvis
and sacrum.
[0030] FIG. 7 is an oblique view of the right sacroiliac joint.
[0031] FIG. 8 is a perspective view of a joint probe.
[0032] FIG. 9 is an enlarged view of the joint probe in FIG. 8.
[0033] FIG. 10 is an end view of the joint probe in FIG. 8.
[0034] FIG. 11 is a perspective view of a guide pin.
[0035] FIG. 12 is an end view of the guide pin in FIG. 11.
[0036] FIG. 13 is a perspective view of a joint cutting
instrument.
[0037] FIG. 14 is an enlarged view of the joint cutting instrument
in FIG. 13.
[0038] FIG. 15 is an end view of the joint cutting instrument in
FIG. 13.
[0039] FIG. 16 is a perspective view of a t-handle addition for a
joint cutting instrument.
[0040] FIG. 17 is an end view of the t-handle addition in FIG.
16.
[0041] FIG. 18 is a perspective view of a joint cutting
assembly.
[0042] FIG. 19 is an exploded, perspective view of the joint
cutting assembly in FIG. 18.
[0043] FIG. 20 is a perspective view of a drill bit.
[0044] FIG. 21 is an end view of the drill bit in FIG. 20.
[0045] FIG. 22 is a perspective view of a fixation pin insertion
assembly.
[0046] FIG. 23 is an exploded, perspective view of the fixation pin
insertion assembly in FIG. 22.
[0047] FIG. 24 is a side view of a box chisel.
[0048] FIG. 25 is a side view of a rasp.
[0049] FIG. 26 is a perspective view of a bone graft impactor.
[0050] FIG. 27 is a perspective view of a surgical tool according
to an embodiment of the present invention.
[0051] FIG. 28 is a side view of a surgical tool according to an
embodiment of the present invention.
[0052] FIG. 29 is a top view of a surgical tool according to an
embodiment of the present invention.
[0053] FIG. 30 is a perspective view of a surgical tool according
to an embodiment of the present invention.
[0054] FIG. 31 is a perspective view of a surgical tool according
to an embodiment of the present invention.
[0055] FIG. 32A is a close-up perspective view of the distal end of
a surgical tool according to an embodiment of the present
invention, where the surgical includes tangs at a distal end
thereof.
[0056] FIG. 32B is a close-up perspective view of the distal end of
a surgical tool according to an embodiment of the present
invention, where the surgical includes tangs at a distal end
thereof.
[0057] FIG. 33 is a perspective view of a surgical tool according
to an embodiment of the present invention.
[0058] FIG. 34 is a side view of a surgical tool according to an
embodiment of the present invention.
[0059] FIG. 35 is a top view of a surgical tool according to an
embodiment of the present invention.
[0060] FIG. 36 is a bottom view of a surgical tool according to an
embodiment of the present invention.
[0061] FIG. 37 is an isolated, top view of a surgical tool
according to an embodiment of the present invention.
[0062] FIG. 38 is a perspective view of a fusion implant inserter
for use with a surgical tool according to an embodiment of the
present invention.
[0063] FIG. 39 is a perspective view of a fusion implant inserter
engaged with a fusion implant for use with a surgical tool
according to an embodiment of the present invention
[0064] FIG. 40 is a cross sectional view of one barrel of a
surgical tool according to an embodiment of the present
invention.
[0065] FIG. 41 is a cross sectional, side view of one barrel a
surgical tool according to an embodiment of the present invention
engaged with a fusion implant inserter.
[0066] FIG. 42 is a cross sectional, side view of one barrel a
surgical tool according to an embodiment of the present invention
engaged with a fusion implant inserter.
[0067] FIG. 43 is a cross sectional, side view of one barrel a
surgical tool according to an embodiment of the present invention
fully engaged with a fusion implant inserter.
[0068] FIG. 44 is a perspective view of a fixation implant
assembly.
[0069] FIG. 45 is an exploded, perspective view of a fixation
implant assembly.
[0070] FIG. 46 is a perspective view of a fixation implant
insertion assembly.
[0071] FIG. 47 is an exploded, perspective view of a fixation
implant insertion assembly.
[0072] FIG. 48 is a perspective view of an adjustable rack for
attaching working channels according to an embodiment of the
present invention.
[0073] FIG. 49 is a perspective view of a fusion implant having
helical fixation elements according to an embodiment of the present
invention.
[0074] FIG. 50 is a side perspective view of a fusion implant
having helical fixation elements according to an embodiment of the
present invention.
[0075] FIG. 51 is a distal view of a fusion implant having helical
fixation elements according to an embodiment of the present
invention.
[0076] FIG. 52 is a perspective view of a fusion implant having a
helical fixation element according to an embodiment of the present
invention.
[0077] FIG. 53 is a side view of a fusion implant having a helical
fixation element according to an embodiment of the present
invention.
[0078] FIG. 54 is a distal view of a fusion implant having a
helical fixation element according to an embodiment of the present
invention.
[0079] FIG. 55 is an oblique, posterior view of the sacroiliac
joint with a fusion implant having helical fixation elements placed
in the sacroiliac joint through a posterior approach according to
an embodiment of the present invention.
[0080] FIG. 56 is a perspective view of a fenestrated sacroiliac
fusion implant having lateral flukes according to an embodiment of
the present invention.
[0081] FIG. 57 is a side perspective view of a fenestrated
sacroiliac fusion implant having lateral flukes according to an
embodiment of the present invention.
[0082] FIG. 58 is an oblique, posterior view of the sacroiliac
joint with a fenestrated fusion implant having lateral flukes
placed in the sacroiliac joint through a posterior approach
according to an embodiment of the present invention.
[0083] FIG. 59 is a perspective view of an open-body, compression
screw sacroiliac fusion implant according to an embodiment of the
present invention.
[0084] FIG. 60 is a superior view of an open-body, compression
screw sacroiliac fusion implant according to an embodiment of the
present invention.
[0085] FIG. 61 is a side view of an open-body, compression screw
sacroiliac fusion implant according to an embodiment of the present
invention.
[0086] FIG. 62 is an oblique, posterior view of the sacroiliac
joint with an open-body, compression screw sacroiliac fusion
implant placed in the sacroiliac joint through a posterior approach
according to an embodiment of the present invention.
[0087] FIG. 63 is a perspective view of an open-body sacroiliac
fusion implant having lateral blades according to an embodiment of
the present invention.
[0088] FIG. 64 is a superior view of an open-body sacroiliac fusion
implant having lateral blades according to an embodiment of the
present invention.
[0089] FIG. 65 is a perspective view of an open-body sacroiliac
fusion implant having detachable lateral blades according to an
embodiment of the present invention.
[0090] FIG. 66 is a perspective view of a detached lateral blade
for an open-body sacroiliac fusion implant according to an
embodiment of the present invention.
[0091] FIG. 67 is an oblique, posterior view of the sacroiliac
joint with an open-body sacroiliac fusion implant having lateral
blades placed in the sacroiliac joint through a posterior approach
according to an embodiment of the present invention.
[0092] FIG. 68 is a perspective view of an open-body sacroiliac
fusion implant having a rotatable member with lateral flukes
according to an embodiment of the present invention.
[0093] FIG. 69 is a proximal view of an open-body sacroiliac fusion
implant having a rotatable member with lateral flukes according to
an embodiment of the present invention.
[0094] FIG. 70 is a side view of an open-body sacroiliac fusion
implant having a rotatable member with lateral flukes according to
an embodiment of the present invention.
[0095] FIG. 71 is an oblique posterior view of the sacroiliac
joint.
[0096] FIG. 72 is an oblique posterior view of the sacroiliac joint
and a joint probe.
[0097] FIG. 73 is an oblique posterior view of the sacroiliac joint
and a joint probe with the joint probe identifying the SI
joint.
[0098] FIG. 74 is an enlarged oblique posterior view of the
sacroiliac joint and a joint probe with the joint probe identifying
the SI joint.
[0099] FIG. 75 is an oblique posterior view of the SI joint and a
joint probe with a guide pin marking the SI joint.
[0100] FIG. 76 is an oblique posterior view of an SI joint with a
joint cutting instrument entering the joint.
[0101] FIG. 77 is an enlarged oblique posterior view of an SI joint
with a joint cutting instrument entering the joint.
[0102] FIG. 78 is an oblique posterior view of a surgical tool
according to an embodiment of the present invention inserted into
an SI joint.
[0103] FIG. 79 is an oblique posterior view of a joint cutting
assembly and a surgical tool according to an embodiment of the
present invention inserted into an SI joint.
[0104] FIG. 80 is an oblique posterior view of an SI joint with a
surgical tool according to an embodiment of the present invention
and a fixation pin assembly.
[0105] FIG. 81 is an enlarged oblique posterior view displaying a
fixation pin assembly and a surgical tool according to an
embodiment of the present invention.
[0106] FIG. 82 is an oblique posterior view of a surgical tool
according to an embodiment of the present invention inserted into
an SI joint with the guide pins marking implant placements.
[0107] FIG. 83 is an enlarged, superior view of a surgical tool
according to an embodiment of the present invention inserted into
an SI joint with the guide pins marking implant placements.
[0108] FIG. 84 is an oblique posterior view of a surgical tool
according to an embodiment of the present invention inserted into
an SI joint with drill bits present in working channel of the
surgical tool.
[0109] FIG. 85 is an enlarged oblique posterior view of a surgical
tool according to an embodiment of the present invention inserted
into an SI joint with drill bits present in working channel of the
surgical tool.
[0110] FIG. 86 is an oblique posterior view of a surgical tool
according to an embodiment of the present invention inserted into
an SI joint with a box chisel inserted into a working channel of
the surgical tool.
[0111] FIG. 87 is an enlarged oblique posterior view of a box
chisel inserted into an SI joint, with a working channel removed
from view for clarity.
[0112] FIG. 88 is an oblique posterior view of a surgical tool
according to an embodiment of the present invention inserted into
an SI joint with a rasp inserted into a working channel of the
surgical tool.
[0113] FIG. 89 is an enlarged oblique posterior view of a rasp
inserted into an SI joint, with a working channel removed from view
for clarity.
[0114] FIG. 90 is an oblique posterior view of a surgical tool
according to an embodiment of the present invention inserted into
an SI joint with a fusion implant inserter inserted into a working
channel of the surgical tool.
[0115] FIG. 91 is an oblique posterior view of a surgical tool
according to an embodiment of the present invention inserted into
an SI joint with an impactor inserted into a working channel of the
surgical tool.
[0116] FIG. 92 is an oblique posterior view of an SI joint with a
joint cutting instrument entering the joint.
[0117] FIG. 93 is an enlarged oblique posterior view of an SI joint
with a joint cutting instrument entering the joint.
[0118] FIG. 94 is an oblique posterior view of a surgical tool
engaged with the sacroiliac joint and the iliac wing according to
an embodiment of the present invention inserted into an SI
joint.
[0119] FIG. 95 is an oblique posterior view of a joint cutting
assembly and a surgical tool engaged with the sacroiliac joint and
the iliac wing according to an embodiment of the present invention
inserted into an SI joint.
[0120] FIG. 96 is an oblique posterior view of an SI joint with a
surgical tool and a fixation pin assembly engaged with the
sacroiliac joint and the iliac wing according to an embodiment of
the present invention.
[0121] FIG. 97 is an enlarged oblique posterior view displaying a
fixation pin assembly and a surgical tool engaged with the
sacroiliac joint and the iliac wing according to an embodiment of
the present invention.
[0122] FIG. 98 is an oblique posterior view of a surgical tool with
the guide pins engaged with the sacroiliac joint and the iliac wing
according to an embodiment of the present invention inserted into
an SI joint.
[0123] FIG. 99 is an enlarged, superior view of a surgical tool
with the guide pins engaged with the sacroiliac joint and the iliac
wing according to an embodiment of the present invention.
[0124] FIG. 100 is a superior view of guide pin placements
according to an embodiment of the present invention.
[0125] FIG. 101 is an enlarged superior view of guide pin
placements according to an embodiment of the present invention.
[0126] FIG. 102 is an enlarged, posterior view of guide pin
placements according to an embodiment of the present invention.
[0127] FIG. 103 is an anterior view of a surgical tool according to
an embodiment of the present invention inserted into an SI joint
with guide pins for guiding fusion implant placement.
[0128] FIG. 104 is a superior view of a surgical tool according to
an embodiment of the present invention engaged into an SI joint
with guide pins for guiding fusion implant placement.
[0129] FIG. 105 is an oblique posterior view of a surgical tool
according to an embodiment of the present invention engaged with an
SI joint and the iliac wing with drill bits present in working
channels of the surgical tool.
[0130] FIG. 106 is an enlarged oblique posterior view of a surgical
tool according to an embodiment of the present invention engaged
with an SI joint and the iliac wing with drill bits present in
working channels of the surgical tool.
[0131] FIG. 107 is an oblique posterior view of a surgical tool
according to an embodiment of the present invention engaged with an
SI joint and the iliac wing with a box chisel inserted into a
working channel of the surgical tool.
[0132] FIG. 108 is an enlarged oblique posterior view of a box
chisel inserted into an SI joint, with a working channel removed
from view for clarity.
[0133] FIG. 109 is an oblique posterior view of a surgical tool
according to an embodiment of the present invention engaged with an
SI joint and the iliac wing with a rasp inserted into a working
channel of the surgical tool.
[0134] FIG. 110 is an enlarged oblique posterior view of a rasp
inserted into an SI joint, with a working channel removed from view
for clarity.
[0135] FIG. 111 is an oblique posterior view of a surgical tool
according to an embodiment of the present invention engaged with an
SI joint and the iliac wing with an impactor inserted into a
working channel of the surgical tool.
[0136] FIG. 112 is an enlarged oblique posterior view of an
impactor inserted into an SI joint, with a working channel removed
from view for clarity.
[0137] FIG. 113 is an oblique posterior view of a surgical tool
according to an embodiment of the present invention inserted into
an SI joint with a fusion implant inserter placed in a working
channel of the surgical tool.
[0138] FIG. 114 is an oblique posterior view of a surgical tool
according to an embodiment of the present invention inserted into
an SI joint with an impactor inserted into a working channel of the
surgical tool.
[0139] FIG. 115 is an enlarged, oblique view of a fusion implant
and a fixation implant in place in the sacroiliac joint and the
iliac wing and sacrum, respectively, where the fixation implant
does not pass through the sacroiliac joint.
[0140] FIG. 116 is an enlarged, superior view of a fusion implant
and a fixation implant in place in the sacroiliac joint and the
iliac wing and sacrum, respectively.
[0141] FIG. 117 is a posterior view of a pelvis with a surgical
tool according to an embodiment of the present invention inserted
into an SI joint.
[0142] FIG. 118 is a posterior view of a pelvis with a surgical
tool according to an embodiment of the present invention with two
independent working channels, one inserted into an SI joint and one
positioned over an iliac crest.
[0143] FIG. 119 is a posterior view of a pelvis with a surgical
tool according to an embodiment of the present invention with two
independent working channels attached by an adjustable rack.
[0144] FIG. 120 is a posterior view of a pelvis with a surgical
tool according to an embodiment of the present invention with two
parallel barrels.
[0145] FIG. 121 is an enlarged posterior view showing two fusion
implants inserted in an SI joint.
[0146] FIG. 122 is a posterior view of a pelvis with a surgical
tool according to an embodiment of the present invention with two
independent working channels, one inserted into an SI joint and one
inserted over an iliac crest. The working channel inserted into the
SI joint may have two barrels for the placement of two fusion
devices in the SI joint.
[0147] FIG. 123 is an enlarged posterior view showing two fusion
devices inserted in an SI joint and one fixation device in the
ilium.
[0148] FIG. 124 is a superior view showing two fusion devices
inserted in an SI joint and one fixation device in the ilium.
[0149] FIG. 125 is a posterior view of a pelvis with two surgical
tools according to an embodiment of the present invention with a
bilateral placement of the two surgical tools for the placement of
bilateral implants.
[0150] FIG. 126 shows a perspective view of a fusion implant,
according to an embodiment of the present invention.
[0151] FIG. 127 shows a side view of a fusion implant, according to
an embodiment of the present invention.
[0152] FIG. 128 shows a cross-sectional view of a fusion implant,
according to an embodiment of the present invention.
DETAILED DESCRIPTION
[0153] Reference will now be made in detail to certain embodiments
of the invention, examples of which are illustrated in the
accompanying drawings. While the invention will be described in
reference to these figures and certain implementations and examples
of the embodiments, it will be understood that such implementations
and examples are not intended to limit the invention. To the
contrary, the invention is intended to cover alternatives,
modifications, and equivalents that are included within the spirit
and scope of the invention as defined by the claims. In the
following disclosure, specific details are given to provide a
thorough understanding of the invention. References to various
features of the "present invention" throughout this document do not
mean that all claimed embodiments or methods must include the
referenced features. It will be apparent to one skilled in the art
that the present invention may be practiced without these specific
details or features.
[0154] Reference will be made to the exemplary illustrations in the
accompanying drawings, and like reference characters may be used to
designate like or corresponding parts throughout the several views
of the drawings.
[0155] The present invention relates to novel fusion implants and
surgical tools designed for repairing a damaged or injured
sacroiliac joint in a human patient, and methods for using such
fusion implants and tools in procedures for repairing the damaged
or injured sacroiliac joint. More specifically, the present
invention pertains to a method for compressing, fixing, and fusing
a damaged sacroiliac joint using a fusion implant having fixation
element(s) (e.g., integrally formed fixation elements) and a
channel or cavity for holding bone growth-promoting materials that
provides for mechanical stability and promotes the formation of a
contiguous piece of bone from the sacrum to the ilium. The fusion
implants may be applied to the SI joint through a novel surgical
tool (e.g., an exposure device) without the need for additional
patient positioning or secondary surgery.
[0156] With respect to some embodiments, an approach is described
to address the SI joint through a posterior approach while
delivering a fusion implant device that may both compress and fix
the SI joint and deliver bone growth-promoting material (e.g.,
autologous bone, allograft, BMP, etc.). The fusion implant may be
delivered to the joint, placed between the sacrum and ilium, and
one or more fixation elements (e.g., integral fixation elements) of
the fusion implant may be engaged with bone tissue in the articular
surfaces of the sacrum and ilium of the patient to thereby compress
and fix the SI joint. In some embodiments, an additional fixation
device may be delivered through the iliac wing and into the sacrum
to assist in mechanically fixing the ilium and sacrum together,
without the fixation device entering or traversing the SI
joint.
[0157] An exemplary exposure device may include a working channel
for guiding various surgical tools during a minimally invasive SI
joint repair procedure. The surgical tool may allow the insertion
of a fusion implant into the SI joint through the working channel
in the surgical tool and guide the placement of the fusion implant
into the SI joint. The tool enables a minimally invasive surgical
method for repairing an SI joint that results in a secure,
consistent, and reliable fusion of the SI joint. The surgical tool
enables the insertion of the fusion implant into the SI joint while
avoiding damage to the soft and connective tissues in and around
the SI joint by closely controlling the placement of the fusion
implant. The surgical tool may have a barrel or cannula through
which the fusion implant is passed into the SI joint that has an
interior perimeter shape that is complementary to and/or
accommodative of the perimeter shape of the fusion implant. For
example, and without limitation, the fusion implant may have
lateral fixation elements (e.g., flukes or blades) for engaging
with bone tissue in the articular surfaces of the sacrum and/or
ilium within the sacroiliac joint, and the interior of the cannula
or barrel may have an oblong or elliptical cross-sectional shape or
lateral slots such that the lateral fixation elements of the fusion
implant can be passed through the barrel or cannula without
obstruction. The matching of the perimeter shapes of the interior
of the barrel and the fusion implant may also allow the fusion
implant to be properly oriented for placement in the SI joint. In
some examples, and without limitation, the interior of the barrel
may also include longitudinal notches that may be engaged with tabs
or protrusions on the fusion implant in order to maintain proper
orientation of the fusion implant within the barrel.
[0158] In some embodiments, the exposure device may include an
additional working channel that is placed laterally to the SI
working channel and over the iliac wing. The additional working
channel may allow for the insertion of a fixation device (e.g.,
surgical screw) into the ilium and sacrum to aid in mechanically
securing the SI joint. The additional channel may enable the
insertion of a joint fixation device (e.g., a screw or other
stabilizing device) into the ilium and sacrum such that the
additional joint fixation device does not enter or traverse (pass
through) the SI joint, thereby further avoiding damage to
connective tissue of the SI joint.
[0159] Relevant Anatomy Description
[0160] Referring to the drawings, FIG. 1 displays the bony anatomy
of the sacrum and pelvis in a frontal, or anterior, view. The SI
joint 102 is located between the ilium, or iliac wing, 100 and the
sacrum 101 at the base of the pelvis 201. Additionally, the
ridgeline of the articular process, the lateral ala 203 and the
pedicle 104 of vertebrae S1 can be observed in this view. In FIG.
2, it can be seen that the SI joint 102 is not fully exposed for
direct visualization from a rear, or posterior, viewpoint due to
the angled and raised iliac crest 200 of the iliac wing 100. This
angle provides a landmark for the entry point of the exposure
device of the present invention at the posterior iliac crest. In
FIG. 3 and FIG. 4, the prominence of the iliac crest 200 is
displayed, along with the large surface area of the iliac wing 100,
while the SI joint is fully enclosed between the iliac wing 100 and
the sacrum 101 and occluded for direct visualization by the iliac
wing 100. Again, the landmark of the posterior iliac crest can be
seen. From a top down view, or superior view, the sacroiliac joint
102 can be fully observed between the iliac wing 100 and the sacrum
101, as shown in FIG. 5. Also shown in FIG. 5, the full sacrum 101
and specifically the vertebral body 103 of S1. The posterior
superior iliac crest and the entry point of the S1 pedicle 104 can
be observed in a direct line from one another (see also FIGS.
110-111).
[0161] In FIG. 6, it can be again observed that the SI joint is
occluded from direct visualization due to the anatomy of the sacrum
101, the ilium 100 and the pelvis 201. Therefore, the only direct
visualization of the SI joint can be achieved through an anterior,
superior or posterior-oblique view of the sacrum and pelvis. Due to
major organs being present in the pelvic-sacral cavity (colon,
rectum, bladder, etc.), an anterior or superior approach to the
bony anatomy and, specifically the SI joint, presents an
unreasonable risk. Lateral approaches can be performed as described
in Published U.S. Pat. No. 5,334,205 to Cain, entitled "Sacroiliac
Joint Fixation Guide," incorporated herein by reference and
Published U.S. Pat. No. 8,221,428 to Trieu, entitled "Sacro-iliac
joint implant system, method and instrument," incorporated herein
by reference. However, these techniques rely on non-direct
confirmation methods such as navigation and fluoroscopy to
determine accurate landmark and sacroiliac joint locations.
[0162] The present invention provides for novel surgical techniques
and novel fusion implant and instrument designs which allow for a
direct visualization of the SI joint by utilizing a
posterior-oblique access method to the anatomy as displayed in the
oblique view of FIG. 7. In this drawing, the SI joint 102 can be
clearly viewed between the right ilium 100 and sacrum 101. A
corresponding joint may be exposed through the same approach on the
left hand side. Additionally, the anatomical landmark of the right
posterior iliac crest and the corresponding access to the S1
pedicle 104 can be seen through this approach.
[0163] Instruments
[0164] The present invention utilizes a novel exposure device and a
surgical tool kit that may be used in a novel surgical method to
introduce and secure a fusion implant in a patient's SI joint. The
present invention also relates to novel fusion implants that may be
implanted into the SI joint, for example, by the novel surgical
tools and methods of the present invention. Exemplary tools are
described herein.
[0165] The novel exposure device may be a surgical guiding tool
having a working channel therein for guiding other surgical tools
for use in repairing an SI joint.
[0166] FIGS. 27-32B, show exemplary exposure devices 137 and 137a
for accessing a sacroiliac joint is shown, having a working channel
239 that may be engaged with a posterior side of the sacroiliac
joint. The working channels of the exposure devices may have a
hollow barrel therein for passing various surgical tools that may
have a shape corresponding to (complementary to) the hollow barrel.
The working channel may provide a guide for inserting the various
surgical tools into the SI joint, allowing precise surgical
incisions, insertions of the fusion implant, etc. The barrel of the
working channel may have an interior perimeter shape that is
complementary to and/or accommodative of the perimeter shape of a
fusion implant may be passed into the SI joint. The matching of the
perimeter shapes of the interior of the barrel and the fusion
implant may allow the fusion implant to be properly oriented for
placement in the SI joint. For example, and without limitation, the
exemplary exposure device 137 has a barrel having a substantially
circular interior cross-section that may accommodate fusion
implants that have circular cross-section (e.g., a helical implant)
or a cross-section having a greatest diameter that is less than the
diameter of the interior cross-section of the barrel.
[0167] In a further example, and without limitation, the barrel
exposure device 137a may have an oblong or elliptical interior
cross-section 190a, where the elongated portions of the barrel
(e.g., the portions of the interior cross-section of the barrel
that near the end of the major axis of the elliptical shape) act as
channels through which lateral extensions of a fusion implant
(e.g., a fusion implant having flukes or blades) may pass without
obstruction. The interior of the barrel may have other shapes as
well. For example, and without limitation, the interior perimeter
of the barrel may have two lateral slots spaced at about
180.degree. from one another in order to accommodate two lateral
flukes, hooks, or blades extending from a body of an SI fusion
implant. The working channel 239 may also have one or more pin
guide slots 139 on one or more sides thereof for insertion of
fixing pins to immobilize the exposure device 137 or 137a when it
is engaged with the SI joint. In other implementations, and without
limitation, a stabilizing arm (e.g., a retractor arm--not shown)
may be engaged with a handle 140 and/or slot 141 in the handle in
order hold the exposure device in a static and stable position.
[0168] The working channel 239 may have one or more windows 138 in
the sides of the hollow barrel allowing the progress of a tool
inserted therein to be observed through the one or more windows.
For example, a surgical implement (e.g., a dilator) inserted into
the hollow barrel of working channel 239 may have notches and/or
unit markings on a side thereof that are visible through the one or
more windows 138, allowing the progress and depth of the surgical
implement to be precisely known. The windows 138 may also allow
access to the surgical implements inserted into the working
channel. If a surgical implement becomes difficult to remove during
a surgical procedure due to the presence of fluid in the hollow
barrel of the working channel (e.g., creating suction), appropriate
tools can be used to access the surgical instrument through the
window(s) 138 to aid in the removal of the surgical implement.
[0169] Referring to FIG. 29, the hollow barrel of the working
channel 239 may have a slot 146 (e.g., a timing feature) that
arrests the progress of a surgical implement inserted into the
hollow barrel of the channel. The slot 146 prevents the surgical
implement from advance too far into the SI joint or the ilium and
sacrum, thereby preventing damage to the tissue of the patient. The
surgical implements used in connection with the exposure device 137
may have a protrusion that is complementary to the slot 146, such
that the slot is effective in controlling a depth to which the
surgical implement can be inserted. The slot 146 also may ensure
that such surgical implements having a complementary protrusion are
and remain properly oriented in the hollow barrel of the working
channel, with no axial movement, during the surgical procedure.
[0170] The hollow barrel of the working channel may also have
guiding slots therein for properly aligning instruments (e.g., a
fusion implant inserter, an impactor, etc.) and/or fusion implants
for passage through the hollow barrel. The guiding slots may engage
notches or protrusions on the instruments or implants such that the
notches or protrusions slide along the guiding slots as the
instrument or fusion implant is advanced through the hollow barrel.
For example, and without limitation, guiding slots 146a are shown
in the hollow barrel of exposure device 137a in FIG. 31. The
guiding slots 146a are located at 180.degree. relative to one
another in the hollow barrel, but the invention is not limited to
such an arrangement. Various implementations of the exposure device
of the present invention may have one or more guiding slots (e.g.,
1, 2, 3, etc.) and they may be arranged in various spatial
arrangements within the hollow barrel.
[0171] The insertable end 142 of the working channel 239 may have a
rounded circular or oblong geometry that prevents or reduces damage
to the soft and connective tissues in and around the posterior side
of the SI joint. Guide channels having other shapes (e.g.,
rectangular or square) may damage soft tissues around the SI joint
when the guide channel is inserted therein. The round geometry of
the insertable end 142 favorably reduces or prevents such damage.
The round or circular insertable end 142 may also have a tapered or
rounded profile, which may further aid in reducing or preventing
damage to the soft and connective tissues around the SI joint. It
is to be appreciated that the present invention is not limited to
working channels having round, circular, or rounded ends. The
working channels may have other perimeter shapes circular, oval,
triangular, polygonal (pentagonal, hexagonal, etc.), Reuleaux
shapes, and other applicable shapes.
[0172] The insertable end of the working channel may also include
one or more prongs or tangs that extend beyond the end of the
hollow barrel. The one or more prongs or tangs may allow the
working channel to be more easily centered in the SI joint (e.g.,
with the tangs aligned along the plane between the articular
surfaces of the SI joint), and may also serve to help stabilize the
position of the working channel in the SI joint. For example, and
without limitation, FIGS. 30, 32A, and 32B show embodiments of an
exposure device that includes tangs 180a and 180b extending from
the distal, insertable end of exposure devices 137b and 137b. The
tangs 180a and 180b are positioned 180.degree. relative to one
another on the end of the hollow barrel, but the invention is not
limited to such an arrangement. In some embodiments (e.g., an
embodiment exemplified by 137b shown in FIG. 32A), and without
limitation, the tangs 180a and 180b may be included at the ends of
the major axis of the oblong (e.g., elliptical) end of the working
channel, which may be used with an implant having lateral fixation
elements such as flukes that may be rotated into the bone tissue
after being placed in the SI joint. In other embodiments (e.g., an
embodiment exemplified by 137c shown in FIG. 32B), and without
limitation, the tangs 180a and 180b may be included at the ends of
the minor axis of the oblong (e.g., elliptical) end of the working
channel, which may be used with an implant having lateral fixation
elements such as lateral plates that may be inserted direct into
the bone tissue of the SI joint.
[0173] The working channel may have other additional features such
as handles 140 and slots 141 therein (e.g., for inserting handle
extensions, etc.), as well. Additionally, the handle 140 may also
be attachable to a stabilizing structure (e.g., a table or surgical
arm, retractor/stabilizing arms, etc.) to prevent movement of the
exposure device or surgical implements engaged therewith during
surgical procedure. It is to be appreciated that the above
description of the exposure tool does not limit the present
invention, and other features are contemplated in and within the
scope of the present invention.
[0174] In some embodiments the invention may comprise a
double-barreled working channel having side by side (e.g.,
parallel) hollow barrels, each able to receive and guide surgical
implements. The two barrels may have a same or different length. In
reference to FIG. 120, a double-barreled working channel 295 may
have first and second parallel barrels. Working channel 295 may
allow multiple fusion implants to be inserted into an SI joint. In
such embodiments, the additional working channel of the
double-barreled working channel may have similar features as
described above with respect to the working channel 239.
[0175] In some embodiments of the present invention, and without
limitation, the exposure device may be a surgical guiding tool
having two working channels therein for guiding other surgical
tools for use in repairing an SI joint. The two working channels
may be attached to one another by a connecting member, such as a
bar or a rack. The bar may have a bend or angle therein that
positions the two working channels at an angle (with respect to
their longitudinal axes) relative to one another in a range of
0.degree. to 180.degree.. In some embodiments, the angle between
the two working channels may be acute (e.g., about 30.degree. to
about 50.degree., or any angle in that range, such as about
45.degree.). The angled positions of the two working channels
allows one working channel to be positioned over the SI joint and
the second working channel to be positioned over the ilium (e.g.,
the iliac wing) simultaneously and snugly, enabling the insertion
of one more joint fusion implants into the SI joint and a joint
fixation device (e.g., a bone screw) into the ilium and sacrum in a
single procedure with a simple tool, without the need to reposition
the surgical tool to insert either the joint fusion implants or the
fixation device. In further embodiments, the relative angle of
orientation of the two working channels may be a right angle or may
be obtuse, depending on the desired insertion point on the ilium.
If a different entry point for a joint fusion device is desired,
the relative orientation angle of the two working channels may be
in a range of about 45.degree. to about 180.degree. (e.g., about
90.degree. to about 180.degree., about 45.degree. to about
135.degree., about 90.degree. to about 120.degree., or any value or
range of values therein). For example, if the desired entry point
on the ilium is more lateral or anterior, the angle of orientation
between the two working channels may be 90.degree. or greater.
[0176] Referring to FIGS. 33-37, a dual working channel exposure
device 300 is shown having a connecting bar 337 connecting a first
working channel 339 and a second working channel 350. The
connecting bar 337 may have a bend or angle 343 between the first
and second working channels 339 and 350. In some implementations,
and without limiting the invention, the bend 343 may have an obtuse
angle in a range of about 110.degree. to about 160.degree. (e.g.,
about 135.degree. or any value therein). In some implementations,
and without limiting the invention, the bend 343 may result in the
first and second working channels being positioned at an acute
angle relative to one another that may be complementary to the
obtuse angle of the bend 343. In alternative implementations, and
without limitation, the connecting bar may have a lockable joint
therein between the first and second working channels 339 and 350
that may be adjusted to have an angle in a of about 90.degree. to
about 180.degree. (e.g., about 135.degree. or any value therein).
The angle of the connecting bar 343 is configured to accommodate
the contour of the pelvis between the ilium and the SI joint such
that the first working channel 339 can be engaged with a posterior
side of the sacroiliac joint and the second working channel 350 can
be engaged with a posterior portion of the ilium
simultaneously.
[0177] The connecting bar 337 may also have a second angle therein,
as shown in the top perspective of FIG. 35 and the bottom
perspective of FIG. 36. The first and second working channels 339
and 350 may be position at an angle between about 5.degree. and
about 40.degree. (e.g., about 15.degree., or any angle therein). To
further illustrate, the bar 343 may be angled such that the
longitudinal axes of the first and second working channels 339 and
350 may run along different, but parallel planes. Thus, the working
channels 339 and 350 are positioned at an acute angle relative to
one another from a side perspective (e.g., FIG. 34), and on
parallel planes relative to each other from top or bottom
perspective (e.g., FIGS. 35 and 36). The additional angle in the
connecting bar 343 may aid in positioning the second working
channel 350 on the ilium when the first working channel is engaged
with the SI joint, such that the second working channel 350 is
positioned over the iliac wing, close to the iliac crest. The
position and angle of the second working channel 350 may allow the
insertion of a bone fusion device (e.g., a bone screw) through the
ilium and the sacrum (e.g., the S1 vertebrae) through the hollow
barrel of the second working channel 350, such that the bone fusion
device does not traverse the SI joint (e.g., it is inserted
anteriorly to the SI joint).
[0178] Each working channel may have a hollow barrel therein for
passing various surgical tools that have a shape corresponding to
(e.g., complementary to) the hollow barrel. The working channels
provide a guide for inserting the various surgical tools into the
SI joint and the ilium, allowing precise surgical incisions,
insertions of fusion implants, bone-growth promoting material, etc.
The working channel position over the SI joint may have a hollow
barrel having an oblong or elliptical internal cross-section or
other shape for accommodating fusion implants having one or more
lateral fixation elements, as discussed above. Each of the first
and second working channels 339 and 350 may have one or more pin
guide slots 349 on a side thereof for insertion of fixing pins to
immobilize the exposure device 300 when it is engaged with the SI
joint and the ilium. The first and second working channels may also
each have one or more windows 338 in sides of the hollow barrels
allowing the progress of a tool inserted therein to be observed
through the one or more windows, and allow access to instruments in
the working channels through the windows, similarly to window 138
described above.
[0179] Referring to FIG. 37, the hollow barrels of the first and
second working channels 339 and 350 may have a slot 346 (e.g., a
timing feature) that arrests the progress of a surgical implement
inserted into the hollow barrel of the channel. The slot 346 may
prevent the surgical implement from advance too far into the SI
joint or the ilium and sacrum and may ensure that surgical tools
passed through the hollow barrels remain properly oriented, with no
axial movement, thereby preventing damage to the tissue of the
patient. The surgical implements used in connection with the dual
working channel surgical tool may have a protrusion that is
complementary to the slot 346, such that the slot is effective in
controlling a depth to which the surgical implement can be
inserted.
[0180] The insertable end 342 of the first working channel 339 may
have a round or circular geometry that prevents or reduces damage
to the soft and connective tissues in and around the posterior side
of the SI joint. The round or circular insertable end 342 may also
have a tapered or rounded profile, which may aid in reducing or
preventing damage to the soft and connective tissues around the SI
joint. The second working channel 350 may also have circular and/or
rounded or tapered insertable end 342, as well. It is to be
appreciated that the present invention is not limited to working
channels having round, circular, oblong or otherwise rounded ends.
The insertable end of the working channel 339 may also include one
or more prongs or tangs that extend beyond the end of the hollow
barrel, as discussed above. The one or more prongs or tangs may
allow the working channel to be more easily centered in the SI
joint (e.g., with the tangs aligned along the plane between the
articular surfaces of the SI joint), and may also serve to help
stabilize the position of the working channel in the SI joint.
[0181] The first and second working channels may have other
additional features such as handles 340 and slots 341 therein
(e.g., for inserting handle extensions), as well. It is to be
appreciated that the above description of the surgical tool does
not limit the present invention, and other features are
contemplated in the present invention.
[0182] In some embodiments the invention may comprise one or more
separate working channels that may be used in a similar manner to
the dual working channel exposure device. In reference to FIG. 119,
the invention may include first and second working channels 290,
which can be individually positioned, for example, with one
inserted into the posterior of the SI joint, and another positioned
over the iliac wing. In such embodiments, the individual working
channels may have the same features described above with respect to
the dual working channel exposure devices described herein, except
for the connecting bar 343 and the features particular thereto.
[0183] In some embodiments, the invention may include a kit or set
of surgical implements and one or more joint fusion implants and
joint fixation devices (e.g., surgical screws) that are associated
with one or more of the exposure devices described above. Various
tools may be included in such a set, including a joint cutting
instrument (e.g., dilator), guide pins, guide pin assemblies, a
drill, drill bits, a rasp, a box chisel, an inserter, and an
impactor. Each of such tools may correspond to the exposure devices
described herein. For example, the joint cutting instrument, the
drill bits, the rasp, the box chisel, the inserter, and the
impactor each may have a shape that is complementary to a hollow
barrel of the exposure device, allowing each instrument to be
inserted into the hollow barrel flush and in the proper
orientation, without room to deviate from the path of the barrel.
Thus, the working channel of the exposure device may act as precise
guides for the surgical implements described above.
[0184] These surgical implements may be made of any suitable
material, including medical grade plastics, metals, or alloys. In
some embodiments, and without limitation, the tools are single use,
in other embodiments the tools may be reused (and autoclaved,
cleaned or otherwise suitably disinfected for further use). The
tools may have various configurations, including those that differ
from those depicted and specifically described herein.
[0185] The implements may include a joint probe capable of being
used to locate an insertion point in an SI joint for a fusion
implant. The joint probe may have a hollow channel therethrough for
inserting a guide wire into the SI joint once the joint probe is
properly positioned in the insertion point. Referring to FIGS.
8-11, the joint probe may have a rounded tip 111 for locating the
insertion point, a shaft 112, and a handle 110. A hollow channel
113 run through the length of the joint probe to allow a guide wire
to be inserted therethrough and into the SI joint.
[0186] The set of tools may also include guide pins for securing
the exposure device to the SI joint and the ilium. Referring to
FIGS. 11-12, the guide pin 115 may have shaft that corresponds to
the central channel of the joint probe and may be inserted into the
SI joint through the dilator, to guide tools and implements
subsequently positioned in said SI joint.
[0187] The set of surgical implements may include a dilator, which
may be any device or structure capable of dilating an incision made
in a human or other animal. FIGS. 13-19 illustrate an example of a
dilator system that may be included in the present invention.
Dilator 116 may be made of any suitable material and may have any
suitable dimensions and configuration. In the depicted example,
dilator 116 has a distal end 117, a proximal end 118, and a shaft
therebetween. Proximal end 118 may have any configuration suitable
to dilate an opening or incision, for example an incision made by a
pin or wire in the patient's flesh and dilate that incision to
increase its size. The proximal end 118 may be tapered, coming to a
point at its end. The distal end 117 may be faceted, allowing it to
be engaged with a grooved end 120 of a T-handle 119. A dilator
assembly, an example of which is shown in FIGS. 18 and 19, allows
the dilator to be spun or otherwise manipulated to adjust the size
of an incision. The dilator 116 (and the t-handle 119) may have a
central channel 213 running down its length that may allow a guide
wire or pin to be inserted therethrough into the incision.
[0188] Fixing pins 126 and a fixing pin handle 125, as shown in
FIGS. 22-23, may be included in the set of tools that correspond to
the pin guide slots 139 on sides of the working channels of the
exposure devices. The guide pins may also have a sharp and/or
threaded end 115 for piercing bone and other tissues. The fixing
pins may correspond to the pin guide holes on sides of the working
channels (e.g., pin holes 139, and 349) of the exposure devices
described above. The fixing pins can be used to secure the working
channels in a desired position over the SI joint or the ilium.
[0189] A drill 122, as shown in FIGS. 20-21, may be included in the
set to allow for bone preparation for fusion implant insertion. The
drill may have a thread portion 124 with numerous designs in order
to provide a hole with the desired female thread cut in the desired
anatomy. The drill may also be designed to be attached to power
instruments, a hand drill or a handle. Without limiting the
invention, FIG. 20 an exemplary drill having a Jacob's chuck
connection 123 so that it may be attached to a powered drill for
quick preparation. Additionally, the drill may have a central
channel 124 running down its length that may allow a guide wire or
pin 114 to be inserted there through into the incision as seen in
FIG. 21.
[0190] A chisel 131, as shown in FIG. 24, may be included in the
set to provide an opening in the bone with desired dimensions on
its distal tip 134 to better facilitate entry for the fusion
implant. The distal tip 134 may have a tapered nose in order to
self-distract its way in between the sacrum and ilium. The distal
tip 134 may also have cutting edges to dig into the bone and remove
it from the surgical site. The chisel may be used to penetrate the
cortical tissue of the sacrum and ilium to allow anchoring portions
of the joint fusion implants of the present invention to penetrate
the bone tissue and thereby anchor the fusion implant in the joint.
The distal tip 134 may also have a containment device for removal
of surgical site bone and windows may exist in the containment
device to collect bone debris and remove the bone debris after
removal from surgical site. The distal tip 134 may be undersized to
a fusion implant to be inserted in order to ensure full bony
contact on all sides of the fusion site. The chisel may have an
outer diameter, as seen in FIG. 24, that matches the inner diameter
of a working channel (e.g., working channels 239, 339, and 350) to
keep the chisel directed in an axial plane for desired implant
preparation. The chisel may have a timing feature 133 that mates
with a female timing feature (e.g., timing feature 146 or 346) on
the inside of a working channel to keep the chisel from plunging
too far into the surgical site and to further keep the chisel in
the proper orientation for desired implant site preparation.
[0191] Additionally, a rasp 132, as shown in FIG. 25, may be
included in the set to provide an opening in the bone with desired
dimensions on its distal tip 135 to better prepare the bone for a
fusion site for the fusion implant. The distal tip 135 may have a
tapered nose in order to self-distract its way in between the
sacrum and ilium. The distal tip 135 may have aggressive teeth
which can scrape the bone to help prepare the bone surface for
receiving anchoring portions of joint fusion implants of the
present invention. The rasp may have an outer diameter as seen in
FIG. 25, that matches the inner diameter of a working channel
(e.g., working channels 239, 339, and 350) to keep the rasp
directed in an axial plane for desired implant preparation. The
rasp may have a timing feature 133 that mates with a female timing
feature (e.g., timing feature 146 or 346) on the inside of a
working channel to keep the instrument from traveling too far into
the surgical site and to further keep the instrument in the proper
orientation for desired implant site preparation.
[0192] One or more impactors, such as impactor 136 shown in FIG.
26, may be included in the surgical implements, as well. The
impactor may have a cylindrical proximal end, like a hammer. The
impactor may be included in the set to facilitate secondary
impaction and movement of a fusion implant and, optionally, to
advance bone-fusion promoting materials in the SI joint in front of
and/or behind the implant to better prepare the surgical site and
to promote fusion of the SI joint. The impactor may have an outer
diameter, as seen in FIG. 26, that matches the inner diameter of a
working channel (e.g., working channels 239, 339, and 350) to keep
the instrument directed in an axial plane for desired surgical site
preparation.
[0193] Inserters for fusion devices may be included in the set to
facilitate delivery of implants or grafts into the sacroiliac joint
and into the ilium and sacrum. Without limiting the invention, FIG.
38 shows an exemplary fusion inserter 147 can be used to deliver a
fusion implant of desired materials such as PEEK, metal or biologic
material into the surgical site. As seen in FIG. 38, the inserter
may have a thumbwheel 148 that is attached to a spring element 150.
When thumbwheel 148 is tightened, spring element 150 may be
tightened down onto an fusion implant to keep the implant from
disengaging from the inserter during implantation. Fork arms 149
may enter recesses on a proximal end of the fusion implant to keep
the implant from losing its desired orientation during insertion.
Upon desired placement of the fusion implant, thumbwheel 148 may be
loosened and the spring element 150 detaches from the implant,
leaving the implant in the desired position. Without limiting the
invention, FIG. 39 shows an inserter 147 engaged with an exemplary
fusion implant 151. In this example, and without limitation, the
implant 151 has notices on the lateral sides thereof that may be
engaged by the fork arms of inserter 147.
[0194] The inserter 147 may have an outer diameter as seen in FIG.
38, that matches the inner diameter of a working channel (e.g.,
working channels 239, 339, and 350) to keep the inserter directed
in an axial plane for desired implant preparation. The inserter may
have a timing feature 150 that mates with a female timing feature
(e.g., timing feature 146 or 346) on the inside of a working
channel (e.g., working channels 239, 339, and 350) to keep the
instrument from traveling too far into the surgical site and to
further keep the instrument in the proper orientation for desired
implant site preparation.
[0195] Instrument kit of the present invention may additionally
include a driver (e.g., a manual or electrically powered driver,
etc.) for inserting joint fixation devices, such as surgical
screws, into bone tissue in the articular surfaces of the SI joint
and/or into the bone tissue of the ilium and sacrum without the
fusion device traversing the SI joint. For example, a bone screw
158 (e.g., a compression screw) may passed through a working
channel positioned over an iliac wing and driven through the ilium
and sacrum with fixation device driver 125. In other examples,
surgical screws 603 and 604 shown in FIGS. 59-61 may be inserted
through a working channel over the SI joint and passed into fusion
implant 600 at an oblique angle by a special driver having a
universal joint or a flexshaft (not shown) that is operable drive
the screws into the articular surfaces of the sacrum and ilium at
oblique angles in order to secure the fusion implant 600 in the SI
joint.
[0196] The surgical kits of the present invention may also include
one or more of the joint fusion implants disclosed herein, and a
particular kit may include an exposure device having an internal
cross-section that corresponds to a shape of the one or more joint
fusion implants that are included in the kit. The surgical kits may
also include one or more joint fixation devices (e.g., surgical
screws) for fixing the ilium and sacrum together.
[0197] It is to be appreciated that additional surgical tools or
implements may be used with the present working channels, and that
the invention is not limited to use of the implements described in
this section.
[0198] Fusion Implants
[0199] The present invention also relates to fusion implants that
include fixation element(s) that mechanically secure and compress
the SI joint, and deliver bone-growth promoting material into the
SI joint to facilitate the formation of a contiguous piece of bone
from the sacrum to the ilium. The fusion implants of the present
invention may be applied to the sacroiliac joint through the novel
exposure devices described herein. The novel posterior exposure
devices and the combined fixation and stability, compression, and
fusion functionalities of the fusion implants of the present
invention may allow for posterior approach that may eliminate the
need for patient repositioning or further incisions, resulting in
less surgery time, less morbidity, and improved recovery time for
the patient. Thus, the surgical methods and fusion implants of the
present invention allow for a minimally invasive methodology.
[0200] To create fixation, stability, and compression from a
posterior implant in the sacroiliac joint, the fusion implants of
the present invention draw together, connect, and hold the
articular surfaces of both the sacrum and ilium together, while
stimulating a fusion of the articular surfaces. The joint fusion
device may create stress and pressure on the bone tissue by
mechanically drawing the bones together, and may thereby utilize
bone remodeling (e.g., as according to Wolff's Law) to promote
stable and robust bone fusion in the targeted joint. The various
embodiments of the fusion implants of the present invention all
contain mechanisms that connect both the sacrum and the ilium
independently, while using a body thereof to bridge across the two
bones for a fusion site. Each of the various embodiments of the
fusion implant may include a channel or cavity that may be used to
hold bone-growth stimulating materials in the form of autologous
bone, allograft, BMP, etc.
[0201] In some embodiments of the fusion implant, and without
limitation, the fusion implant may have one or more helical anchors
for insertion into bone tissue. In such embodiments, the fusion
implant may also include a channel or cavity for holding bone
growth-enhancing material for promoting fusion of adjacent bones
held together by the fusion implant. For example, and without
limitation, a fusion implant may include a single helix or multiple
helices (e.g., 2 or 3 helices) that may be concentric and/or
interwoven. In some embodiments, and without limitation, the
helical path of the helical fixation anchors may have a uniform
diameter from their proximal end to the distal end thereof.
However, in other embodiments, and without limitation, the helical
path of the helical fixation anchors may taper outward or inward
from the proximal end to the distal end of the helical path to
create a conical shape to the helical path.
[0202] Without limiting the invention, FIGS. 49-51 show an
exemplary fusion implant 400 having two helical anchors. The
implant 400 has a body 401 attached to two helical anchors 403 and
404, which may be concentric and interwoven. Each of the helical
anchors 403 and 404 may have a distal cutting edge 405 that may be
operable to penetrate bone tissue in joint targeted for fusion. The
distal cutting edges of each of the helical anchors 403 and 404 may
be on opposite sides of the fusion implant 400 such that as the
implant is advanced into the SI joint, the helical anchor 403
engages the ilium and helical anchor 404 engages the sacrum. The
body 401 of the fusion implant 400 may have notches or slots 402 in
a perimeter thereof that may be engaged by a fusion implant
inserter or driver as described herein (e.g., by fork arms 149).
The implant 400 may have a outer diameter in a range of about 8 mm
to about 20 mm (e.g., about 12 mm to about 18 mm, or any other
value or range of values therein). The implant may be paired with a
exposure device having a hollow barrel with an internal
cross-section that corresponds to the diameter and cross-sectional
shape of the implant.
[0203] In other embodiments, and without limitation, the fusion
implant may have a single helix attached to the body of the fusion
implant. For example, and without limitation, FIGS. 52-54
illustrate an exemplary fusion implant 400a that may include a
single helical anchor 403a. The fusion implant 400a has a body 401a
attached to the helical anchor 403a, which may have a distal
cutting edge 405a that may be operable to penetrate bone tissue in
joint targeted for fusion. After being inserted into the SI joint
the body 401a may be rotated in a range of about 180.degree. to
about 360.degree. (e.g. about 270.degree., or any value or range of
values therein) such that helical anchor 403a may engage the
articular surfaces of both the ilium and the sacrum so that the
fusion implant can compress the bones together and stabilize the SI
joint. The body 401a of the fusion implant 400a may have notches or
slots 402a in a perimeter thereof that may be engaged by a fusion
implant inserter or driver as described herein (e.g., by fork arms
149).
[0204] The process of inserting and advancing the fusion implant
400 (or 400a, or other related embodiments) may be performed by one
or more tools that engage the notches or slots 402 (or 402a). An
inserter (e.g., inserter 147) may be used to initially place the
fusion implant 400 (or 400a, or other related embodiment) in a
desired position between the sacrum and ilium, and the inserter may
be subsequently rotated to engage the helical anchors with the bone
tissue of the articular surfaces of the sacrum and ilium. For
example, and without limitation, a driving tool may be attached to
the inserter to aid in rotating the inserter. As the fusion implant
is rotated, the sacrum and ilium bones may be pulled towards each
other and the sacroiliac joint may be compressed and stabilized.
Cutting edges 405 may be pierce the bone tissue (e.g., cortical
and/or cancellous/spongy bone tissue) of the sacrum and ilium. As
shown in FIGS. 49-50, but without limitation, the cutting edges 405
of the helical anchors 403 and 404 are aligned with the notches 402
for receiving the inserter tool. This alignment may be included in
order to position the cutting edges in a precise position within
the joint. For example, the alignment allows the surgeon to control
insertion of the cutting edges such that the cutting edge of one of
the helical anchors is positioned at the targeted articular surface
of the sacrum and the cutting edge of the other helical anchor is
positioned at the targeted articular surface of the ilium. In such
implementations, the position of the cutting edges can be
controlled by the aligning the inserter with the plane of the joint
(the plane between the articular surfaces), and thereby placing the
cutting edges in close proximity to the targeted articular surfaces
such that they engage and penetrate the articular surfaces
immediately upon rotation of the inserter. Other embodiments of the
fusion implant (e.g., those having a single helical anchor, or
flukes, claws, etc.) may also be inserted such that the portion of
the fusion implant for engaged with the bone tissue is positioned
adjacent to the targeted articular surface when inserted into the
joint and prior to rotation of the implant.
[0205] In some implementations, and without limitation, surgical
tools (e.g., a drill, chisel, rasp, etc.) may be used to remove
cortical tissue from the targeted articular surfaces of the sacrum
and ilium to prepare ("prep") the articular surfaces for engagement
with the fusion implant before the fusion implant is inserted into
the joint, allowing the helical anchors of the fusion implant to
more easily pierce the bone tissue of the sacrum and ilium. In such
implementations, and without limitation, the fusion implant may be
inserted into the joint such that the cutting edges of the fusion
implant may be aligned with and adjacent to the prepped articular
surfaces.
[0206] In some implementations, and without limitation, the fusion
implant may include a cannulated channel or cavity that allows for
the addition of bone growth-stimulating materials into the targeted
joint. For example, and without limitation, the fusion implant 400
(or 400a, or other related embodiment) may include a cannulated
channel (e.g., 406) running from a central hole in the proximal end
of body (e.g., 401) through the one or more helical anchors (e.g.,
403 and 404) to the distal end(s) of the one or more helical
anchors (e.g., 403 and 404). The cannulated channel may be packed
with bone growth-stimulating materials (e.g., autologous bone,
allograft, BMP, etc.) to stimulate bone growth across the fusion
implant and the joint that may lead to fusion of the sacrum and
ilium. Without limiting the invention, the bone growth-stimulating
materials may be inserted into the channel through a proximal hole
in the body after the fusion implant is set into desired operative
position. In other implementations, the bone growth-stimulating
materials may be present in the channel prior to insertion of the
fusion implant into the SI joint.
[0207] As an example, and without limitation, FIG. 50 provides a
side view of the fusion implant 400 in which the length of the
cannulated channel 406 can be seen running from the proximal hole
in the body 401 to the distal ends of the helical anchors 403 and
404. FIG. 51 provides a bottom view of the implant 400 and shows
the complete cannulated channel 406 and the concentric and
interwoven pattern of the helical anchors 403 and 404. However, it
should be understood that the present invention is not limited to
the particular arrangement of the exemplary helical anchors 403 and
404 in FIGS. 49-51. For example, and without limitation, FIG. 53
provides a side view of fusion implant 400a in which the length of
cannulated channel 406a can be seen running from a proximal hole in
the body 401 to the distal end of the helical anchor 403a. FIG. 54
provides a bottom view of fusion implant 400a showing the complete
cannulated channel 406a.
[0208] FIG. 55 displays the fusion implant 400 in its desired
operative position in the sacroiliac joint 102, where helical
anchors 403 is engaged with the ilium 200 and anchor 404 is engaged
with the sacrum 101. The implant may create stability and fixation
across the joint, compression in the joint, and bone
growth-promoting material can be added to the cannulated channel
406 to aid in fusion of the sacrum and ilium at the site of the
fusion implant. It is to be understood that other related
embodiments (e.g., fusion implant 400a) may be placed in the joint
in the same manner. It is also to be understood that multiple
fusion implants may be placed into the sacroiliac joint from the
posterior approach. For example, and without limitation, the
double-barreled exposure device 295 shown in FIGS. 118-119, which
has two side by side (e.g., parallel) working channels may be used
to introduce two fusion implants into the SI joint.
[0209] In other embodiments of the fusion implant, and without
limitation, the fusion implant may have a central body with flukes,
claws, hooks, or other bone engaging structures attached thereto.
Additionally, the central body may have a channel or cavity in
which bone growth-enhancing materials may be included. Without
limiting the invention, FIGS. 56-57 show an exemplary embodiment of
a fusion implant 500 having lateral flukes 503 and 504 for engaging
with the targeted articular surfaces of the SI joint. Each of the
lateral flukes 503 and 504 may have a distal hooking ends 505 that
may be operable to penetrate bone tissue in joint targeted for
fusion. The distal cutting edges of each of the lateral flukes 503
and 504 may be on opposite sides of the fusion implant 500 such
that as the fusion implant is advanced into the SI joint, the
lateral fluke 503 engages the ilium and lateral fluke 504 engages
the sacrum. The proximal end of the body 501 of the fusion implant
500 may have notches or slots 502 in a perimeter thereof that may
be engaged by a fusion implant inserter or driver as described
herein (e.g., by fork arms 149). The notches or slots 502 may allow
the inserter to turn the fusion implant 500 (e.g., in a clockwise
direction) to allow for the lateral flukes 503 and 504 to pull the
sacrum and ilium towards each other, creating compression. The
implant 500 may have a minimum (smallest) outer diameter in a range
of about 8 mm to about 20 mm (e.g., about 12 mm to about 18 mm, or
any other value or range of values therein), and a maximum
(largest) outer diameter in a range of about of about 12 mm to
about 40 mm (e.g., about 15 mm to about 30 mm, or any other value
or range of values therein). The implant may be paired with an
exposure device having a hollow barrel with an internal
cross-section that corresponds to the outer diameters and
cross-sectional shape of the implant.
[0210] The fusion implant 500 may include a cannulated channel or
cavity 506 that allows for the addition of bone growth-stimulating
materials into the targeted joint. For example, and without
limitation, the fusion implant 500 includes cannulated channel 506
running from a central hole in the proximal end of body 501 a
distal hole 508 in the body 501. The cannulated channel 506 may be
packed with bone growth-stimulating materials (e.g., autologous
bone, allograft, BMP, etc.) to stimulate bone growth across the
fusion implant and the joint that may lead to fusion of the sacrum
and ilium. The body 501 may have a number of fenestrations 507
therein to allow for lateral bone growth through the implant, which
may result in a stable fusion site between the sacrum and ilium.
Without limiting the invention, the bone growth-stimulating
materials may be inserted into the channel 506 through the proximal
hole in the body 501 after the fusion implant 500 is set into
desired operative position. In other implementations, the bone
growth-stimulating materials may be present in the channel 506
prior to insertion of the fusion implant 500 into the SI joint.
[0211] The process of inserting and advancing the fusion implant
500 may be performed by one or more tools that engage the notches
or slots 502. An inserter (e.g., inserter 147) may be used to
initially place the fusion implant 500 in a desired position
between the sacrum and ilium. Without limiting the invention, FIG.
54 shows the fusion implant 500 having a self-distracting bullet
nose 509. The bullet nose may have a round geometry and/or a
tapered rounded profile that is operable to distract the SI joint
with minimal damage to soft and connective tissue in and around the
posterior side of the SI joint. The bullet nose 509 may facilitate
entry into the sacroiliac joint prior to the lateral flukes 503 and
504 being rotated into place in the sacrum and ilium. The sloped
bullet nose 509 and the inserter may be subsequently rotated to
engage the lateral flukes 503 and 504 with the bone tissue of the
articular surfaces of the sacrum and ilium. As the fusion implant
500 is rotated, the sacrum and ilium bones may be pulled towards
each other and the sacroiliac joint may be compressed and
stabilized. Hooking ends 505 may pierce the bone tissue (e.g.,
cortical and/or cancellous/spongy bone tissue) of the sacrum and
ilium. As shown in FIGS. 56-57, but without limitation, the lateral
flukes 503 and 504 may be aligned with the notches 502 for
receiving the inserter tool. This alignment may be included in
order to position the cutting edges in a precise position within
the joint (e.g., with the lateral flukes aligned with the plane of
the joint between the articular surfaces such that the hooking ends
are positioned at the targeted articular surfaces).
[0212] As discussed above, and without limiting the invention, the
working channel through which the implant is passed into the SI
joint may have an oblong cross-sectional shape or slots running
along its length for accommodating the lateral flukes of the
implant. For example, and without limitation, the channel may have
a hollow barrel with slots may be separated by about 180.degree.
along the length of the working channel and may have a shape that
can accommodate the shape of the lateral flukes (e.g., a generally
rectangular shape that is sufficiently large to accommodate the
shape of the lateral flukes).
[0213] FIG. 58 displays the implant 500 in a desired operative
position in the sacroiliac joint 102, where lateral fluke 503 is
engaged with the ilium 200 and lateral fluke 504 is engaged with
the sacrum 101. The implant may create stability and fixation
across the joint, compression in the joint, and bone
growth-promoting material can be added to the cannulated channel
506 to aid in fusion of the sacrum and ilium at the site of the
fusion implant.
[0214] In other embodiments of the fusion implant, and without
limitation, the fusion implant may have a box-like open body having
holes therein for receiving one or more surgical screws for
attaching the fusion implant to the sacrum and/or ilium. Without
limiting the invention, FIGS. 59-61 show an exemplary embodiment of
a fusion implant 600 having a box-like body 601 having holes 602a
and 602b in a proximal end thereof for receiving surgical screws
603 and 604 for engaging with the targeted articular surfaces of
the SI joint and holding the fusion implant 600 in place within the
SI joint. The body 601 may be designed such that a central plane of
the body 601 bisecting the proximal end of the body 601 and
bisecting screw holes 602a and 602b may be roughly aligned with the
plane of the SI joint between the articular surfaces when the
fusion implant is inserted into the SI joint. The box-like geometry
of the fusion implant 600 may resist torsional stress applied by
movement of the SI joint. The implant 600 may have a minimum
(smallest) outer diameter in a range of about 8 mm to about 20 mm
(e.g., about 12 mm to about 18 mm, or any other value or range of
values therein), and a maximum (largest) outer diameter in a range
of about of about 12 mm to about 40 mm (e.g., about 15 mm to about
30 mm, or any other value or range of values therein). The implant
may be paired with an exposure device having a hollow barrel with
an internal cross-section that corresponds to the outer diameters
and cross-sectional shape of the implant.
[0215] The screw holes 602a and 602b may be angled obliquely with
respect to the central plane of the body 601. For example, and
without limitation, hole 602a may run obliquely toward a first
lateral side of the central plane, and hole 602b may run obliquely
toward a second (and opposite) lateral side of the central plane.
This arrangement allows the surgical screw 603 inserted through
screw hole 602a to engage one of the bones in the SI joint (e.g.,
the sacrum) and the surgical screw 604 inserted through screw hole
602b to engage with the other bone in the SI joint (e.g., the
ilium).
[0216] Without limiting the invention, the surgical screws 603 and
604 may be self-drilling screws that can penetrate the bone tissue
(e.g., cortical and/or cancellous/spongy bone tissue) of the
articular surface. The articular surfaces of the sacrum and/or the
ilium may be prepared for the insertion of the surgical screws by
removing cortical tissue at the insertion point for the screws or
pre-drilling holes for the screws; in such embodiments,
self-drilling screws may or may not be utilized. In some
implementations, the surgical screws may be doubled threaded screws
that create compression of the joints, which may draw the sacrum
and ilium together as they are advanced into the bone tissue. The
screws may be driven into the bone tissue of the ilium and sacrum
by a driving device passed through the working channel positioned
over the SI joint, where the driving device has a universal joint
or flex shaft (not shown) that allows it to drive the screws into
the ilium and sacrum at oblique angles.
[0217] The open body 601 of the implant 600 may have a cavity in
which bone growth-enhancing materials may be included. The fusion
implant 600 may have an open design, where there are no sidewalls
closing off the cavity 606 to the articular surfaces of the sacrum
and ilium so that bone growth stimulating material that may be
placed within the cavity 606 may be in contact with the articular
surfaces of the sacrum and ilium within the joint to allow fusion
growth across the SI joint. FIG. 61 shows a side view of the fusion
implant 600, in which it can be seen that the fusion implant 600
may have a cavity 606 that is completely open on the lateral sides
with no sidewalls to obstruct contact between bone
growth-stimulating materials in the cavity 606 and the articular
surfaces of the sacrum and ilium. As shown in FIG. 60, the fusion
implant 600 may further include openings 607 along the outer wall
of the fusion implant to allow further access to the bone
growth-stimulating material in the cavity 606.
[0218] The process of inserting and advancing the fusion implant
600 may be performed by one or more tools that advance the implant
through a working channel, as described herein. An inserter (e.g.,
inserter 147) may be used to initially place the fusion implant in
a desired position between the sacrum and ilium. In some
embodiments, and without limitation, the fusion implant may include
slots or notches on the proximal end thereof (not shown), which the
inserter can engage. In other embodiments, and without limitation,
the inserter may engage the lateral edges of the proximal end of
the fusion implant. Once the fusion implant 600 is placed in the
targeted position in the SI joint, the surgical screws 603 and 604
may be advanced through screw holes 602a and 602b, respectively. As
the surgical screws 603 and 604 are advanced into the bone tissue
of the sacrum and ilium, the sacrum and ilium bones may be pulled
towards each other and the sacroiliac joint may be compressed and
stabilized. The surgical screws 603 and 604 may pierce the bone
tissue (e.g., cortical and/or cancellous/spongy bone tissue) of the
sacrum and ilium.
[0219] As discussed above, and without limiting the invention, the
working channel through which the implant is passed into the SI
joint may have an oblong cross-sectional shape or slots running
along its length for accommodating the width of the fusion implant
600. For example, and without limitation, the working channel may
have a hollow barrel having slots may be separated by about
180.degree. along the length of the working channel and may have a
shape that may accommodate the shape of the body of the fusion
implant.
[0220] FIG. 62 displays the implant 600 in a desired operative
position in the sacroiliac joint 102, where surgical screw 603 may
be engaged with the ilium 200 and surgical screw 604 may be engaged
with the sacrum 101. The implant may create stability and fixation
across the joint, compression in the joint, and bone
growth-promoting material can be added to the cavity 606 to aid in
fusion of the sacrum and ilium at the site of the fusion
implant.
[0221] In other embodiments of the fusion implant, and without
limitation, the fusion implant may have a box-like central body
having laterally extending blades for engaging the sacrum and/or
ilium. Without limiting the invention, FIGS. 63-64 show an
exemplary embodiments of a fusion implant 700 having a box-like
body 701 having laterally extending blades 703 and 704 for engaging
with the targeted articular surfaces of the SI joint and holding
the fusion implant 700 in place within the SI joint. The body 701
may be designed such that a central plane of the body 701 bisecting
the proximal end of the body 701 may be roughly parallel or aligned
with the plane of the SI joint between the articular surfaces when
the fusion implant 700 is inserted into the SI joint. The box-like
geometry of the fusion implant 700 may resist torsional stress
applied by movement of the SI joint. The implant 700 may have a
minimum (smallest) outer diameter in a range of about 8 mm to about
20 mm (e.g., about 12 mm to about 18 mm, or any other value or
range of values therein), and a maximum (largest) outer diameter in
a range of about of about 12 mm to about 40 mm (e.g., about 15 mm
to about 30 mm, or any other value or range of values therein). The
implant may be paired with an exposure device having a hollow
barrel with an internal cross-section that corresponds to the outer
diameters and cross-sectional shape of the implant.
[0222] The lateral blades 703 and 704 may be angled obliquely with
respect to the central plane of the body 701. For example, and
without limitation, blade 703 may run obliquely toward a first
lateral side of the central plane, and blade 704 may run obliquely
toward a second (and opposite) lateral side of the central plane.
This arrangement allows the blade 703 to engage one of the bones in
the SI joint (e.g., the sacrum) and the blade 704 to engage with
the other bone in the SI joint (e.g., the ilium). The lateral
blades may be separately formed or integral to the fusion implant
700. The lateral blades may have an outer edge 705 for engagement
with the bone tissue of the sacrum or ilium. The outer edge may
have varying geometry to facilitate entry into and compression of
the sacrum and ilium. In some implementations, and without
limitation, the outer edges of the lateral blades may have a sharp
cutting edge which can penetrate the bone tissue. In some
implementations, and without limitation, the outer edges may be
serrated (e.g., with one or more kinds of teeth, such as triangular
teeth, hook teeth, crown teeth, etc.). The outer edge may
facilitate penetration of the lateral blades into the bone tissue
(e.g., cortical and/or cancellous/spongy bone tissue) of the
articular surfaces of the ilium and sacrum when the fusion implant
is advanced into the SI joint. In some implementations, and without
limitation, the articular surfaces of the sacrum and/or the ilium
may be prepared for the insertion of the lateral blades by removing
cortical tissue at the insertion point.
[0223] The body 701 of the implant 700 may have a cavity 706 in
which bone growth-enhancing materials may be included. The fusion
implant 700 may have an open design, where there are no sidewalls
closing off the cavity 706 to the articular surfaces of the sacrum
and ilium so that bone growth stimulating material that may be
placed within the cavity 706 may be in contact with the articular
surfaces of the sacrum and ilium within the joint to allow fusion
growth across the SI joint. As shown in FIG. 64, the fusion implant
700 may further include openings 707 along the outer wall of the
fusion implant to allow further access to the bone
growth-stimulating material in the cavity 706. The fusion implant
700 may include a central hole 708 in the proximal end of the body
701. The central hole 708 may allow for access into the cavity 706,
allowing the bone growth-stimulating materials to be inserted into
the cavity 706 either before or after the fusion implant 700 is set
into desired operative position in the SI joint. In some
implementations, the bone growth-stimulating materials may be
present in the cavity 706 prior to insertion of the fusion implant
700 into the SI joint. The design of fusion implant 700 (and other
related embodiments) allows for bone graft to be placed
pre-operatively as the cavity 706 is not obscured by the lateral
blades (bone anchoring mechanism).
[0224] The process of inserting and advancing the fusion implant
700 may be performed by one or more tools that advance the implant
through a working channel, as described herein. An inserter (e.g.,
inserter 147) may be used to initially place the fusion implant in
a desired position between the sacrum and ilium. In some
embodiments, and without limitation, the fusion implant may include
slots or notches on the proximal end thereof (not shown), which the
inserter can engage. In other embodiments, and without limitation,
the inserter may engage the lateral edges of the proximal end of
the fusion implant. The fusion implant 700 may be drive into place
in the targeted position in the SI joint by the inserter. As the
fusion implant 700 is advanced into the SI joint, the lateral
blades 703 and 704 are driven into and penetrate the bone tissue of
the sacrum and ilium, and the blades 703 and 704 may act to draw in
the sacrum and ilium bones and the sacroiliac joint may be
compressed and stabilized. The lateral blades 703 and 704 may
pierce the bone tissue (e.g., cortical and/or cancellous/spongy
bone tissue) of the sacrum and ilium as the fusion implant is
driven into the SI joint. In other implementations, and without
limitation, the inserter may be used to place the fusion implant
700 at the SI joint, and subsequently an impactor or other driving
tool may be used to drive the fusion implant 700 into the bone
tissue and into position in the SI joint.
[0225] As discussed above, and without limiting the invention, the
working channel through which the implant is passed into the SI
joint may have a hollow barrel having an oblong interior
cross-sectional shape or slots running along its length for
accommodating the width of the fusion implant 700 and the lateral
blades 703 and 704. For example, and without limitation, a first
set of slots may be separated by about 180.degree. along the length
of the working channel and may have a shape that is complementary
to or large enough accommodate the shape of the fusion implant, and
a second set of slots may be separated by about 180.degree. along
the length of the working channel and may have a shape may
accommodate the shape of the lateral blades.
[0226] FIGS. 65-66 show a fusion implant 700a that is similar to
implant 700 in shape, size, and function, but the blades 703a and
703b of implant 700a are detachable from the implant. As shown in
FIG. 65, the lateral blades 703a and 703b are inserted into slots
710a and 710b in the distal portion of the body 701a, respectively.
This fusion implant embodiment allows for the body 701a to be
inserted into the SI joint prior to the insertion of the blades
703a and 703b into the body 701a. This may allow the implant 700a
to be inserted into the SI joint and the blades to be subsequently
inserted into the slots 710a and 710b and engaged with the bone
tissue of the ilium and sacrum without the need for a specially
shaped (e.g., oblong or slotted) working channel. The blades 703a
and 703b may be passed through the working channel and into slots
710a and 710b after the body 701a has been positioned in the SI
joint. An inserter and/or impactor or other tools may be used to
insert the blades 703a and 703b into the slots 710a and 710b and
into the bone tissue of the ilium and sacrum.
[0227] As shown in FIG. 66, the blades of implant 700a may include
pressure clips 711 that engage with slots 710a and 710b when the
blades are inserted into the slots. The pressure clips may lock the
blades into the slots to help stabilize the fusion implant.
[0228] FIG. 67 displays the implant 700 (or implant 700a) in a
desired operative position in the sacroiliac joint 102, where
lateral blade 703 is engaged with the ilium 200 and lateral blade
704 is engaged with the sacrum 101. The implant may create
stability and fixation across the joint, compression in the joint,
and bone growth-promoting material can be added to the cavity 706
to aid in fusion of the sacrum and ilium at the site of the fusion
implant.
[0229] In other embodiments of the fusion implant, and without
limitation, the fusion implant may have a box-like central body
having a rotatable central axle with lateral flukes thereon for
engaging the sacrum and/or ilium as the central axle is rotated.
Without limiting the invention, FIGS. 68-69 show an exemplary
embodiment of a fusion implant 800 having a box-like open body 801
having a central axel 805 to which two flukes 803 and 804 are
attached for engaging with the targeted articular surfaces of the
SI joint and holding the fusion implant 800 in place within the SI
joint. The flukes 803 and 804 may engage with the articular
surfaces of the sacrum and ilium, respectively, when the central
axis is rotated. The body 801 may be designed such that a central
plane of the body 801 bisecting the proximal end of the body 801
may be roughly parallel to or aligned with the plane of the SI
joint between the articular surfaces when the fusion implant 800 is
inserted into the SI joint. The box-like geometry of the fusion
implant 800 may resist torsional stress applied by movement of the
SI joint. The implant 800 may have a minimum (smallest) outer
diameter in a range of about 8 mm to about 20 mm (e.g., about 12 mm
to about 18 mm, or any other value or range of values therein), and
a maximum (largest) outer diameter in a range of about of about 12
mm to about 40 mm (e.g., about 15 mm to about 30 mm, or any other
value or range of values therein). The implant may be paired with
an exposure device having a hollow barrel with an internal
cross-section that corresponds to the outer diameters and
cross-sectional shape of the implant.
[0230] Without limiting the invention, the flukes 803 and 804 may
extend out laterally from central rotating axis 805 at about
180.degree. from each other. This arrangement allows the fluke 803
to engage one of the bones in the SI joint (e.g., the sacrum) and
the fluke 804 to engage with the other bone in the SI joint (e.g.,
the ilium) as the central axle 805 is rotated. In other
implementations, and without limitation, the flukes may have other
relative positions on the central axle. In still other
implementations, and without limitation, the fusion implant may
have more than two flukes attached to the central axis that may be
arranged in various positions on the central rotating axle. Without
limiting the invention, the curvature of all of the flukes
extending from the central axle may be oriented in either a
clockwise or counterclockwise fashion when viewing the fusion
implant from the proximal end of the body (e.g., like the
perspective of FIG. 69). The consistent orientation of all of the
flukes allows all of the hooks to engage (hook into) the tissue in
the SI joint as the central axle is rotated. In other
implementations, and without limitation, one or more of the flukes
on the central axle may be obliquely oriented, which may provide
additional bite and purchase into the bone tissue. The hooking edge
of the hooks may have varying geometry to facilitate entry into and
compression of the sacrum and ilium. In some implementations, and
without limitation, the hooking edges of the flukes may have a
sharp cutting edge which can penetrate the bone tissue. In some
implementations, and without limitation, the hooking edges may be
serrated (e.g., with one or more kinds of teeth, such as triangular
teeth, hook teeth, crown teeth, etc.). The hooking edges may
facilitate penetration of the flukes into the bone tissue (e.g.,
cortical and/or cancellous/spongy bone tissue) of the articular
surfaces of the ilium and sacrum when the central axle is rotated.
In some implementations, and without limitation, the articular
surfaces of the sacrum and/or the ilium may be prepared for the
insertion of the surgical screws by removing cortical tissue at the
insertion point.
[0231] The body 801 of the implant 800 may have a cavity 806
through which the central axle 805 passes. The central axle may
rotatably attach to both the proximal and distal ends of the body
801, such that the central axle 805 may be rotated once the fusion
implant is inserted into the SI joint. The central axle 805 may be
rotatable in either the clockwise and/or the counterclockwise
direction (e.g., from the perspective of FIG. 69). In some
implementations, and without limitation, the central axle 805 may
be rotatable in only one direction, that being the direction that
allows the hooks to bite into the bone tissue in the SI joint. The
one-directional implementation may prevent the hooks from rotating
and slipping out of the bone tissue, once they have been rotated
and inserted into the bone tissue in the SI joint.
[0232] The cavity 806 may have an open design into which bone
growth-enhancing materials may be inserted. The body 801 may have
no sidewalls closing off the cavity 806 to the articular surfaces
of the sacrum and ilium so that bone growth stimulating material
that may be placed within the cavity 806 may be in contact with the
articular surfaces of the sacrum and ilium within the joint to
allow fusion growth across the SI joint. As shown in FIG. 68, the
fusion implant 800 may further include openings 807 along the outer
wall of the fusion implant 800 to allow further access to the bone
growth-stimulating material in the cavity 806.
[0233] The process of inserting and advancing the fusion implant
800 may be performed by one or more tools that advance the implant
through a working channel, as described herein. An inserter (e.g.,
inserter 147) may be used to initially place the fusion implant in
a desired position between the sacrum and ilium. In some
embodiments, and without limitation, the fusion implant may include
slots or notches on the proximal end thereof (not shown), which the
inserter can engage. In other embodiments, and without limitation,
the inserter may engage the lateral edges of the proximal end of
the fusion implant. Subsequently, a driving tool may be engaged
with a central hole 802 in the proximal end of the body 801, which
may be "keyed" with teeth or other structures that can be engaged
by the driving tool. The driving tool may be operable to rotate the
central axle 805 once it is engaged with the central hole 802,
thereby driving the flukes 803 and 804 into the bone tissue in the
articular surfaces of the sacrum and ilium.
[0234] In some embodiments, and without limitation, the inserter
may have a head that has a complementary shape to the central hole
802, allowing the inserter to engage the with the central hole 802
prior to insertion. The ring structure around the central hole 802
may be connected with or integral to the central axle 805, allowing
central axle to be rotated by the inserter. For example, and
without limitation, the inserter can be used to insert the fusion
implant into the SI joint, and then the head of the inserter may be
rotated in order to rotate the central axle of the fusion implant,
thereby engaging the hooks with the bone tissue in the articular
surfaces of the sacrum and ilium.
[0235] As discussed above, and without limiting the invention, the
working channel through which the implant is passed into the SI
joint may have a hollow barrel having an oblong internal
cross-section or slots running along its length for accommodating
the width of the fusion implant 800 and the lateral flukes 803 and
804.
[0236] The central hole 802 may also allow for access into the
cavity 806, such that bone growth-stimulating materials may be
inserted into the cavity 806 after the fusion implant 800 is set
into desired operative position in the SI joint. In some
implementations, and without limitation, the bone
growth-stimulating materials may be present in the cavity 806 prior
to insertion of the fusion implant 800 into the SI joint. The
design of fusion implant 800 (and other related embodiments) allows
for bone graft to be placed pre-operatively as the cavity 806 is
not obscured by the central axle and hooks (bone anchoring
mechanism).
[0237] In some embodiments, and without limitation, the fusion
implant may have a shape and features like the implant 151 shown in
FIGS. 39 and 126-129. As an example, and without limiting the
invention, the implant may be a bone graft as shown in FIGS.
126-129. The implant 151 may be substantially rectangular, having
ribbing 153 on opposing sides to create a surface for catching or
gripping with the SI joint when it is inserted. The implant 151 may
also have a tapered proximal end to be inserted into the SI joint
to act as a wedge, facilitating insertion. The implant 151 may also
have slots 152 for receiving forceps of an inserter, and transverse
holes to allow bone tissue to grow through the implant and
incorporate the implant into the native bone tissue, thereby fusing
the SI joint.
[0238] FIGS. 71-91 displays the implant in a desired operative
position in the sacroiliac joint 102, where the implant is engaged
with the ilium 200 and the sacrum 101. The implant may create
stability and fixation across the joint, compression in the joint,
and bone growth-promoting material can be added to the cavity 806
to aid in fusion of the sacrum and ilium at the site of the fusion
implant.
[0239] Surgical Methods
[0240] In some embodiments, the methods of the present invention
substantially fuse the SI joint, such that movement in the joint is
minimized or substantially eliminated, thereby diminishing or
substantially eliminating the patient's pain and discomfort. More
specifically, an improved, combined approach for both mechanical
holding and surgical fusion through a novel exposure device is
described herein. Specifically, with respect to some embodiments,
an approach is described to address the SI joint through a
posterior approach. In some embodiments, and without limitation,
the surgical fusion of the sacrum and an ilium may be accomplished
with a posteriorly inserted fusion implant device alone. In other
embodiments, and without limitation, surgical fusion may be
accomplished with the delivery of both (1) a fusion implant device
into the SI joint, and (2) a separate fixation device which can be
in the form of a screw, or the like. The fusion may be delivered to
the SI joint, placed between the sacrum and ilium, while the
fixation device may be delivered through the iliac wing, near the
iliac crest, into the sacrum while not entering or passing through
the SI joint.
[0241] In some embodiments, and without limitation, the method may
involve the posterior insertion of a fusion implant, including the
steps of creating an incision proximal to the patient's SI joint,
dilating the incision, engaging a novel exposure device as
described herein with the incision, creating a void in the SI
joint, and inserting the fusion implant into the void such that it
engages with the articular surfaces of the sacrum and ilium.
[0242] Some embodiments, without limitation, include some or all of
the following steps, preparing the patient for surgery (e.g.,
positioning the patient in a prone position to provide the surgeon
access to the SI joint, general or local anesthesia, and the like),
locating the SI joint and an incision point for access to the SI
joint (e.g., by blunt finger palpation), insertion of a pin or wire
to create an incision, insertion of a dilator over the pin and
impacting the dilator to dilate the incision to a width through
which instruments may be passed, inserting a working channel of a
novel exposure device over the dilator, securing the working
channel in position with fixing pins, removing the dilator,
inserting a drill bit apparatus through the working channel, using
the drill bit apparatus in the working channel to displace bone in
the SI joint thereby creating a void, removing the drill bit
apparatus, loading a fusion implant onto an inserter and inserting
the fusion implant and inserter into the working channel until the
implant is positioned proximal to the void in the patient's SI
joint, inserting an impactor into the first working channel and
applying force to displace the implant into the void in the
patient's SI joint, removing all instruments, and closing the
incision.
[0243] In some embodiments, and without limitation, the method may
involve the posterior insertion a fusion implant and the insertion
a separate fixation device through the ilium and sacrum, including
the steps of creating an incision proximal to the patient's SI
joint, creating an incision over iliac wing, dilating the
incisions, engaging a novel exposure device as described herein
with both incisions, creating a void in the SI joint, inserting a
fusion implant into the void, drilling a hole through the ilium and
the S1 vertebra of the sacrum, and inserting a joint fusing device
in the ilium and sacrum. The fixation device may be inserted
through the iliac wing, near the iliac crest, into the sacrum while
not entering or passing through the SI joint.
[0244] Other embodiments, without limitation, include some or all
of the following steps, preparing the patient for surgery (e.g.,
positioning the patient in a prone position to provide the surgeon
access to the SI joint, general or local anesthesia, and the like),
making a small incision over the top of the iliac wing from a
posterior approach, locating the SI joint and an incision point for
access to the SI joint (e.g., by blunt finger palpation), insertion
of a pin or wire to create an incision, insertion of a dilator over
the pin and impacting the dilator to dilate the incision to a width
through which instruments may be passed, inserting a first working
channel of a double-barreled, double-angled exposure device over
the dilator and inserting a second working channel of said exposure
device in the incision over the iliac wing, securing the first and
second working channels in position with fixing pins, removing the
dilator, inserting a drill bit apparatus through each of the first
and second work channels, using the drill bit apparatus in the
first working channel to displace bone in the SI joint thereby
creating a void, using the drill bit apparatus (or a second drill
bit apparatus) in the second working channel to drill a hole in the
iliac crest and the S1 vertebra of the sacrum, removing the drill
bit apparatus, loading an implant (e.g., a graft) onto an inserter
and inserting the implant and inserter into the first working
channel until the implant is positioned proximal to the void in the
patient's SI joint, inserting an impactor into the first working
channel and applying force to displace the implant into the void in
the patient's SI joint, inserting a joint fusion device coupled to
a fusion device inserter into the second working channel and
implanting said joint fusion device in the hole in the iliac crest
and the sacrum, removing all instruments, and closing the
incisions.
[0245] Some embodiments include the use of embodiments of the tools
or tool sets of the present invention, as described above. Other
embodiments of the methods of the present invention are performed
without using the tools of the present invention. The methods of
the present invention may be performed in addition to or in
conjunction with one or more of the known methods. Embodiments of
the methods of the present invention (and tools of the present
invention) are now further described with reference to the Figures.
Although the methods are described with respect to the use of
certain tools, other tools with different structures may be used
and still be within the scope of the present invention.
[0246] FIGS. 72-99 illustrate a surgical procedure for fusing an SI
joint with both a fusion implant inserted in the SI joint and a
joint fixation device (e.g., a bone screw). The procedure includes
positioning a patient in the prone position and administering
either a local or general anesthetic. Blunt finger palpation may be
used to locate the patient's iliac wing and the SI joint. As shown
in FIG. 72, the SI joint 102 is located between the iliac wing 100
and the sacrum 101 at the base of the pelvis. The SI joint is fully
enclosed between the iliac wing 100 and the sacrum 101 and occluded
for direct visualization by the iliac wing 100. Additionally, the
iliac crest 200, the posterior iliac spines, and the pedicle 104 of
vertebrae S1 can be observed in this view. The iliac crest 200 may
provide a posterior landmark for the entry point of the exposure
device of the present invention at the posterior iliac crest, and
can be palpated to find the general location of the SI joint.
Alternatively, suitable locations for an incision may be determined
by imaging methods (e.g., x-ray), or any other suitable method.
[0247] As illustrated in FIGS. 73-74, and without limitation, a
joint probe 112 may be used to identify the insertion area on the
posterior side of the SI joint. The area of the SI joint may be
probed until the rounded geometry of the joint probe 112 finds or
drops into the proper position in the SI joint, where an incision
may be properly made. Subsequently, a guide pin 114 may be inserted
through a central channel in the joint probe 112 and into the
patient to create an incision in the SI joint, as illustrated in
FIG. 70. Alternatively, the incision may be made by any suitable
method, including scalpel or other cutting or dissection tool. The
incision may be made proximal to the patient's SI joint, allowing
the joint to be accessed by the exposure device. The guide pin 114
may be advanced until its proximal end is in contact with the SI
joint or at least partially within SI joint.
[0248] As illustrated in FIGS. 76-79, and without limitation, a
dilator may be used to dilate the incision. As an example, dilator
116 may be slotted over guide pin 114 through a central channel
running the length of the dilator 116. The proximal end of the
dilator 116 may be slotted over the guide pin 114, and dilator 116
may then be advanced to or near the SI joint through the incision.
As dilator 116 enters the incision, the tapered end 118 pushes the
patient's flesh and tissue aside, thereby dilating incision to
accommodate an exposure device as described herein. A joint cutting
assembly that includes the dilator 116 and a T-handle 120 engaged
with a distal end of the dilator 116 may be used to further drive
the dilator 116 into the incision to a desired depth to
sufficiently expose the SI joint. Alternatively, an impactor (not
shown) may be used to further drive the dilator 116 into the
incision to a desired depth.
[0249] FIG. 76 illustrates the placement of the exposure device 137
over the dilator 116. The exposure device 137 is advanced over
dilator 116 and into incision. Dilator 116 enters the hollow barrel
of exposure tool at the distal end of the working channel 239. The
working channel 239 of the exposure tool has distal end 142 that
may have a round geometry and/or a tapered rounded profile that is
operable to distract the SI joint with minimal damage to soft and
connective tissue in and around the posterior side of the SI joint.
The working channel may include tangs extending from distal end 142
for engaging the SI joint between the sacrum and ilium. The tangs
may align between the articular surfaces and help to position and
stabilize the working channel. It is to be appreciated that the
working channel may have other perimeter shapes such as oval, to
accommodate the shape of some fusion implants. It should be
understood that the working channel may have other shapes as well
(e.g., triangular, polygonal [pentagonal, hexagonal, etc.],
Reuleaux shapes, and other applicable shapes). The exposure device
may also further dilate incision. The exposure device is advanced
toward SI joint through incision until proximal end 142 is in
contact with the SI joint or proximal to the SI joint and in
contact with the sacrum and/or ilium. In such embodiments, dilator
116 functions to guide the proximal end 142 to the patient's SI
joint.
[0250] FIGS. 78-81 illustrate a process of stabilizing the exposure
device 137 within incision. As depicted, the exposure device is
stabilized using fixing pins 126, slotted through fixing pin holes
or slots 139 on sides of the working channel 239. Fixing pins 126
may have any suitable structure that permits them to stabilize the
exposure device 137. In some embodiments, and without limitation,
stabilizing pins 126 can penetrate the skin and/or flesh and tissue
of a human. It is to be appreciated that any suitable method of
stabilizing exposure device may be used. Dilator 116 and guide pin
115 may be removed from the working channel either before or after
the fixing pins 126 are inserted. In other embodiments, and without
limitation, the exposure device may be stabilized by attachment to
a surgical or stabilizing arm to hold the exposure device in a
static and stable position.
[0251] A guide pin 115 may be inserted into the incision through
the working channel 239, either through the dilator before it is
removed, or through a guide sleeve that may be used to insert the
guide pin 115 and then may be removed from the working channel
239.
[0252] FIGS. 82-83 illustrate insertion of drill bit apparatus 122
into the incisions through the working channel 239 of the exposure
device 137. The drill bit may be connected to a power drill
configured for medical procedures. The drill bit apparatus 122 may
have cylindrical outer walls that allow the drill bit apparatus to
freely spin with the hollow barrel of the working channel 239. The
cylindrical outer wall may comprise a low-friction material that
facilitates smooth spinning of the drill within the hollow barrel
of the working channel. The proximal end of the drill bit apparatus
122 may be inserted into the working channel 239 and may be
advanced to a predetermined point. In some examples, and without
limitation, the proximal end of drill bit apparatus 122 does not
extend past the proximal end of the working channel 239 when fully
inserted. Preferably, drill bit apparatus 122 may be configured
such that it will interact with the working channel 239 only in an
orientation that ensures proper positioning of drill bit apparatus
122 relative to the SI joint. For example, and without limitation,
the drill bit apparatus may fit snugly into the hollow barrel to
avoid any axial deviations, but may still be able to spin freely
and at a rapid rotational speed without causing excessive friction
or causing significant extraneous or unwanted motion. In other
embodiments, and without limitation, the drill bit may have an
outer stationary housing that is complementary to and fits snugly
within the hollow barrel of the working channel, and the rotating
portion of the bit may be within the outer stationary housing and
can be rotated while the stationary outer housing is statically
engaged with the hollow barrel of the working channel.
[0253] In some implementations, and without limitation, the drill
bit in the drill bit apparatus 122 may be advanced into the working
channel 239 toward SI joint to a predetermined depth. This may be
accomplished by an arrestor system in the drill that only allows a
particular depth of insertion or by any other suitable method. The
drill bit in the working channel 239 may be positioned such that
when activated it will create a void in the patient's SI joint by
displacing portions of sacrum and ilium. In such examples, the
drill bit may be configured such that it will contact the patient's
SI joint at a desired portion of the joint and, once activated,
will create a void of a desired depth. The void may be configured
to receive a fusion implant as described herein or other joint
repairing appliance or bone graft for fusing the SI joint. Other
joint repairing appliances or apparatus may include a polyether
ether ketone (PEEK) implant, a titanium implant, etc. As an example
and without limiting the invention, the implant may be a fusion
implant like one of those shown in FIGS. 49-70.
[0254] As shown in FIGS. 84-93, several implements may be inserted
through the working channel 239 into the void in the SI joint to
prepare the void for receiving a fusion implant. For instance, a
box chisel 131 and/or a rasp 132 may be inserted into the void
through the working channel 239 to expand and clear tissue from the
void to facilitate a clean and efficient insertion of the fusion
implant into the void (see, e.g., FIGS. 84-86). As shown in FIGS.
88-89, an impactor 136 may also be used to deepen or spread the
void.
[0255] FIGS. 39 and 90 illustrate the use of a fusion implant
inserter 147 to insert a fusion implant into the void in the SI
joint. The inserter 147 may be inserted into the working channel
239 of the exposure device 137 once a void has been formed in the
SI joint. For example, and without limitation, prior to insertion,
the fusion implant is grasped by forceps of the inserter 147, which
may engage with grooves along sides of the fusion implant. In other
examples, and without limitation, the inserter may have a head that
is threaded, keyed, or otherwise structured such that it is
complementary to a hole in the proximal end of the fusion implant
(e.g., the proximal hole in fusion implant 700 or 800). Once
engaged with the fusion implant, the inserter 147 may be inserted
into the working channel and may be advanced until it meets
resistance at the void. The inserter 147 may be operable to then
release the fusion implant, leaving it in the void. In some
examples, the inserter 147 may have a mechanism for grasping and
releasing the fusion implant (e.g., arms 149 may be operable to
clamp and release the fusion implant), providing an efficient means
of depositing the fusion implant in the void.
[0256] In some implementations, and without limitation, the fusion
implant may require that one or more elements thereof be rotated in
order for the fusion implant to engage with the bone tissue in the
SI joint (e.g., fusion implants 400,400a, 500, 800, and other
related embodiments). In some implementations, and without
limitation, the inserter may have arms thereon for engaging slots
or notches in the proximal end of the fusion implant and may be
capable of rotating the fusion implant (e.g., fusion implants 400,
400a, 500, and related embodiments) once it is placed in the SI
joint. In such implementations, the inserter may have distal
rotatable member that is capable of rotating independently of shaft
and handle of the inserter, allowing the surgeon to use the
inserter to place the fusion implant into the void in the proper
orientation without unwanted rotation and then deliberately rotate
the fusion implant and engage it with the articular surfaces. In
other implementations, and without limitation, the inserter may
include a distal head that may be operable to engage a hole in the
proximal surface of the fusion implant, which may be threaded or
machined (e.g., to have gear teeth, notches, angular sides [e.g., a
square shape, etc.] or other features) in a manner to allow an
interlocking fit with the distal head of the inserter. In such
implementations, the distal head may be operable to rotate the
fusion implant once it is placed in the void in the SI joint. In
other implementations, and without limitation, a tool separate from
the inserter may be used to rotate the fusion implant once it is in
place within the SI joint. For example, and without limitation, a
driver having a distal head operable to engage the fusion implant
may be passed through the working channel and engage with the
fusion implant, and subsequently rotate the fusion implant.
[0257] An impactor 236 may be used to exert force on the fusion
implant as it is in the void, in order to drive the fusion implant
securely into the void, as shown in FIG. 91. The impactor may be
utilized to drive the fusion implant into the bone tissue of the
articular surfaces of the SI joint, particularly in implementations
that utilize a fusion implant having lateral blades (e.g., fusion
implant 700 and related embodiments). The fusion implant may
thereby be properly inserted into the void. Though, the impactor
may be used in other implementations as well, for example, to drive
the fusion implant deeper into the void prior to rotating the
fusion implant (e.g., fusion implants 400, 400a, 500, and related
embodiments), or prior to driving screws of the fusion implant into
the articular surfaces of the SI joint (e.g., fusion implant 600
and related embodiments). Additionally, the impactor 236 may be
used to add additional therapeutic materials, such as bone
morphogenetic proteins (BMP), demineralized bone matrix (DBM), stem
cells, and other materials, to the void to improve recovery and
growth of the bone in the SI joint.
[0258] Subsequently, the exposure device may be removed from the
patient. Also, the fixing pins 126 may be removed from both
incisions. The tissues in the incisions may then be sutured, to
facilitate healing.
[0259] In some embodiments of the present invention, and without
limitation, surgical fusion may be accomplished with the delivery
of both (1) a fusion implant device into the SI joint, and (2) a
separate fixation device which can be in the form of a screw, or
the like. The fusion may be delivered to the SI joint, placed
between the sacrum and ilium, while the fixation device may be
delivered through the iliac wing, near the iliac crest, into the
sacrum while not entering or passing through the SI joint. In such
embodiments, the steps of locating the SI joint and making an
incision over the SI joint may be the same or similar to the steps
described above and as shown in FIGS. 71-77.
[0260] FIGS. 92-114 illustrate additional steps of a surgical
procedure for fusing an SI joint with both a fusion implant
inserted in the SI joint and a joint fixation device (e.g., a bone
screw) fixing the ilium and sacrum together. The procedure may
include making an incision over the iliac wing near the iliac crest
for the insertion of a second working channel of a double-barreled,
double-angled exposure device. A dilator may be used to dilate an
incision formed over the SI joint, as previously described. As an
example, and without limitation, FIGS. 92-93 show dilator 116 may
be slotted over a guide pin 114 through a central channel running
the length of the dilator 116. The proximal end of the dilator 116
may be slotted over the guide pin 114, and dilator 116 may then be
advanced to or near the SI joint through incision. As dilator 116
enters the incision, the tapered end 118 pushes the patient's flesh
and tissue aside, thereby dilating incision to accommodate exposure
device. A joint cutting assembly that includes the dilator 116 and
a T-handle 120 engaged with a distal end of the dilator 116 may be
used to further drive the dilator 116 into the incision to a
desired depth to sufficiently expose the SI joint. Alternatively,
an impactor (not shown) may be used to further drive the dilator
116 into the incision to a desired depth.
[0261] FIGS. 94-95 illustrate the placement of the double-barreled,
double-angled exposure device over the dilator 116. The exposure
device is advanced over dilator 116 and into incision. Dilator 116
enters the hollow barrel of exposure tool at the distal end of the
first working channel 239. Without limiting the invention, the
first working channel 239 of the exposure tool has proximal end 142
that may have a round geometry and/or a tapered rounded profile
that is operable to distract the SI joint with minimal damage to
soft and connective tissue in and around the posterior side of the
SI joint. It is to be appreciated that the working channel may have
other perimeter shapes circular, oval, triangular, polygonal
(pentagonal, hexagonal, etc.), Reuleaux shapes, and other
applicable shapes. The exposure device may also further dilate
incision. The exposure device is advanced toward SI joint through
incision until proximal end 142 is in contact with the SI joint or
proximal to the SI joint and in contact with the sacrum and/or
ilium. In such embodiments, dilator 116 functions to guide the
proximal end 142 to the patient's SI joint.
[0262] The exposure device may be configured such that when the
first working channel 239 of the exposure device is established in
position in or near the SI joint the second working channel 240 is
oriented over the iliac wing near the iliac crest (the location of
the incision) and in an orientation that will allow the second
working channel to guide a drill bit through the ilium and sacrum
(e.g., the S1 vertebra) without traversing the SI joint (i.e.,
without causing damage to the SI joint). The relative position of
the first and second working channels of the double-barreled,
double-angled exposure device accommodates the contour of the
pelvis between the ilium and the SI joint such that said first
working channel can be engaged with a posterior side of the SI
joint and said second working channel can be engaged with a
posterior portion of the iliac wing at an angle that is aligns a
longitudinal axis of the second working channel anterior to the SI
joint.
[0263] FIGS. 96-99 illustrate a process of stabilizing the exposure
device within incision. As depicted, the exposure device is
stabilized using fixing pins 126, slotted through fixing pin holes
or slots 139 on sides of the first and second working channels 239
and 240. Fixing pins 126 may have any suitable structure that
permits them to stabilize the exposure device. In some embodiments,
stabilizing pins 126 can penetrate the skin and/or flesh and tissue
of a human. It is to be appreciated that any suitable method of
stabilizing exposure device may be used. Dilator 116 and guide pin
115 may be removed from the first working channel either before or
after the fixing pins 126 are inserted.
[0264] Guide pins 115 may be inserted into the incision through the
first and second working channels 239 and 240, either through the
dilator before it is removed, or through guide sleeves that may be
used to insert the guide pins 115 and that may then be removed from
the first and second working channels 239 and 240. FIGS. 100-102
provide views of exemplary guide pin placement for the
double-barreled exposure device from multiple perspectives. FIGS.
103-104 provide views of exemplary placement of the double-barreled
exposure device from multiple perspectives.
[0265] FIGS. 105-106 illustrate insertion of drill bit apparatus
122 into the incisions through the first and second working
channels 239 and 240 of the exposure device. The drill bit may be
connected to a power drill configured for medical procedures. The
drill bit apparatus 122 may have cylindrical outer walls that allow
the drill bit apparatus to freely spin with the hollow barrel of
the first and second working channels 239 and 240. The cylindrical
outer wall may comprise a low-friction material that facilitates
smooth spinning of the drill within the hollow barrels of the first
and second working channels. The proximal ends of the drill bit
apparatus 122 may be inserted into the first and second working
channels 239 and 240 and may be advanced to a predetermined point.
In some examples, the proximal ends of drill bit apparatus 122 do
not extend past the proximal end of the first and second working
channels 239 and 240 when fully inserted. Preferably, drill bit
apparatus 122 are configured such that it will interact with the
first and second working channels 239 and 240 only in an
orientation that ensures proper positioning of drill bit apparatus
122 relative to the SI joint and the ilium. For example, the drill
bit apparatus may fit snugly into the hollow barrel to avoid any
axial deviations, but may still be able to spin freely and at a
rapid rotational speed without causing excessive friction or
causing significant extraneous or unwanted motion. In other
embodiments, and without limitation, the drill bit may have an
outer stationary housing that is complementary to and fits snugly
within the hollow barrel of the working channel, and the rotating
portion of the bit may be within the outer stationary housing and
can be rotated while the stationary outer housing is statically
engaged with the hollow barrel of the working channel.
[0266] The drill bits in the drill bit apparatus 122 may be
advanced into channel the first and second working channels 239 and
240. With regard to the drill in the first working channel 239, the
drill bit is advanced toward SI joint to a predetermined depth.
This may be accomplished by an arrestor system in the drill that
only allows a particular depth of insertion or by any other
suitable method. The drill bit in the first working channels 239
may be positioned such that when activated it may create a void in
the patient's SI joint by displacing portions of sacrum and ilium.
In such examples, the drill bit may be configured such that it will
contact the patient's SI joint at a desired portion of the joint
and, once activated, will create a void of a desired depth.
[0267] The void may be configured to receive a fusion implant as
described herein or other joint repairing appliance or apparatus
for fusing the SI joint. Other joint repairing appliances apparatus
may include a polyether ether ketone (PEEK) implant, a titanium
implant, etc. As an example and without limiting the invention, the
implant may be a fusion implant like one of those shown in FIGS.
49-70. The fusion implant may also have slots for receiving forceps
of an inserter tool or a hole or recess in a proximal end of the
fusion implant for receiving an inserter tool, and transverse holes
to allow bone tissue to grow through the implant, and incorporate
the implant into the native bone tissue, thereby fusing the SI
joint.
[0268] The drill bit in the second working channels 239 may be
positioned such that when activated it will drill a hole through
the iliac wing of the patient near the iliac crest and through the
sacrum (e.g., the S1 vertebra). The drill bit may have sufficient
length to reach the S1 vertebra from the iliac wing position of the
second working channel. The relative angled position of the first
and second working channels 239 and 240 of the exposure device
positions the second working channel such that the drill bit can be
advanced through to the S1 vertebra without traversing (passing
through) the SI joint, thereby avoiding any damage to the SI joint
tissues (e.g., the ligaments).
[0269] As shown in FIGS. 107-112, several implements may be
inserted through the first working channel 239 into the void in the
SI joint to prepare the void for receiving a fusion implant. For
instance, and without limitation, a box chisel 131 and or a rasp
132 may be inserted into the void through the first working channel
239 to expand and clear tissue from the void to facilitate a clean
and efficient insertion of the fusion implant into the void. An
impactor 136 may also be used to deepen or spread the void.
[0270] FIGS. 39 and 113 illustrate the use of a fusion implant
inserter 147 to insert a fusion implant (e.g., as described above
and shown in FIGS. 49-70) into the void in the SI joint. The
inserter 147 may be inserted into the first working channel 239 of
the exposure device. Prior to insertion, the fusion implant may be
grasped by the forceps of the inserter 147, which may engage with
grooves or recesses on the fusion implant. In other
implementations, and without limitation, the fusion implant may
have a hole or recess in a proximal end of the fusion implant for
receiving an inserter tool, and the inserter tool may have a head
or extension that fits within the hole or recess. The inserter 147
and the fusion implant may be inserted together into the first
working channel and may be advanced until it meets resistance at
the void. The inserter 147 may then release the fusion implant,
leaving it in the void. In some examples, the inserter 147 may have
a mechanism for grasping and releasing the fusion implant,
providing an efficient means of depositing the fusion implant in
the void.
[0271] Subsequently, an impactor 236 may be used to exert force on
the fusion implant in the void, in order to drive fusion implant
securely into the void, as shown in FIG. 114. The fusion implant
may thereby be properly inserted into the void. Additionally, the
impactor 236 may be used to add therapeutic materials, such as bone
morphogenetic proteins (BMP), demineralized bone matrix (DBM), stem
cells, and other materials, to the void to improve recovery and
growth of the bone in the SI joint.
[0272] A joint fixation device (e.g., a compression screw) may be
inserted into the iliac wing and the sacrum (the S1 vertebra)
through the second working channel as the double-barreled exposure
device is secured to the SI joint and the ilium. A fixation device
158 may be inserted at angle into the ilium and the sacrum that
compresses the SI joint, thereby compressing the fusion implant
within the SI joint. However, in other embodiments, the angle of
the hole drilled in the ilium and sacrum in an orientation that
distracts the SI joint, providing room in the SI joint for bone
tissue grow around the fusion implant. In further embodiments, the
structure of the joint fixation device 158 may be configured to
create distraction in the SI joint.
[0273] The joint fixation device 158 may be inserted into the
second working channel along with a fixation implant driver 125
engaged therewith. In the case of a screw, the screw 158 may be
advanced into the hole drilled through the ilium and the sacrum
manually with a specialized driver 125. Alternatively, the screw or
other fusion device can be installed by an automated process.
Without limiting the invention, FIGS. 115-116 show an exemplary
fixation device 158 and an exemplary fusion implant 151 positioned
in the pelvis from posterior and superior views, respectively. The
fusion implant 151 sits in the SI joint 102 between the articular
surfaces of the sacrum 101 and the iliac wing 100. The fixation
device 158 passes through the iliac wing 100 and into the body of
S1 of the sacrum 101 without traversing (passing through) the SI
joint 102.
[0274] Once the fusion implant 151 and the fixation device 158 are
implanted in their proper positions, the fixation implant insertion
implant device 125 and the double-barreled exposure device may be
removed from the patient. Also, the fixing pins 126 may be removed
and the exposure device may be removed from both incisions. The
tissues in the incisions may then be sutured, to facilitate
healing.
[0275] In some embodiments, and without limitation, the working
channels may have different structures and orientations. Without
limiting the invention, FIGS. 117-120 illustrate further
embodiments of the invention. In FIG. 117, a single working channel
290 is shown engaged with the SI joint. In this example, the single
working channel 290 can be individually orientated and engaged with
the SI joint, and separately as second working channel 290 may be
engaged with the preferred insertion point on the ilium, as shown
in FIG. 118. This embodiment provides the flexibility of
individually orienting the two working channels. Subsequently, an
adjustable rack 161 may be engaged with both the of the individual
working channels 290 as shown in FIG. 119, thereby stabilizing the
two working channels and maintaining their orientation relative to
one another. It is to be appreciated that the two working channels
in this example may be stabilized by other or additional
methods.
[0276] In some embodiments, the working channel may have two barrel
or more barrels (e.g., 3, 4, or more barrels, in various
orientations--parallel, skewed, etc.), each capable of receiving
surgical implements and being used to introduce implants or other
devices or materials into the SI joint. For instance, the two or
more barrels may include two parallel barrels, two skewed barrels,
three parallel barrels in a single plane, three parallel barrels in
a triangular arrangement, etc. As an example, and without limiting
the invention, FIG. 120 shows an individual working channel 295
engaged with the SI joint having two parallel barrels. The
additional barrel may facilitate the formation of a second void and
the insertion of a second fusion implant or some other fusion
device or bone graft material in the second void. As an example,
and without limitation, FIG. 121 shows a posterior view of the SI
joint having two fusion implants 151 inserted therein. An exposure
device having two parallel barrels such as working channel 295 may
be used to insert two fusion implants into the SI joint, as shown
in FIG. 121.
[0277] The working channel 295 may be used individually in a SI
joint fusion procedure, or in combination with another working
channel. For example, and without limiting the invention, FIG. 122
shows an exemplary working channel 290 that may be used in
conjunction with the working channel 295, allowing for insertion of
a joint fixation device in the ilium and sacrum. The working
channels 290 and 295 may also be connected to one another by an
adjustable rack, as described above, thereby stabilizing the two
working channels and maintaining their orientation relative to one
another. It is to be appreciated that working channels having two
or more barrels may fixedly attached to a second working channel at
an angle by a connecting member, as described in the examples
above. As an example, and without limitation, FIGS. 123-124 show
posterior and superior views of an SI joint having two fusion
implants 151 inserted therein, and a fixation device 157 implanted
in the iliac wing 100 and the body of S1 of the sacrum 101. The
fusion implants 151 sit in the SI joint 102 between the articular
surfaces of the sacrum 101 and the iliac wing 100. The fixation
device 157 passes through the iliac wing 100 and into the body of
S1 of the sacrum 101 without traversing (passing through) the SI
joint 102. An exposure device having two parallel barrels such as
working channel 295 may be used to insert two fusion implants into
the SI joint, and a second working channel may be used to insert
the joint fixation device in the iliac wing and the sacrum, as
shown in FIGS. 123-124.
[0278] It is also to be appreciated that the individual working
channel having two or more barrels are not limited to SI joint
fusion procedures, and may have other beneficial applications.
Furthermore, the other working channel apparatuses may be useful in
other procedures as well. For instance, the working channels of the
present invention may be associated with various racks (e.g.,
having varying lengths and means of attachment) that facilitate
procedures where two difficult surgical sites are needed.
[0279] It is to be further appreciated that the working channel
apparatuses (exposure devices) described herein can be utilized in
SI joint fusion procedures on both SI joints of a patient
simultaneously. As shown in FIG. 125, the presently described
exposure devices can be utilized in a bilateral SI joint
procedure.
[0280] The methods described herein may be used to treat both of
the patient's SI joints either at the same or approximately the
same time (e.g., during the same procedure) or in sequence.
[0281] It is to be understood that variations and modifications of
the present invention may be made without departing from the scope
thereof. It is also to be understood that the present invention is
not to be limited by the specific embodiments disclosed herein, but
only in accordance with the appended claims when read in light of
the foregoing specification.
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