U.S. patent application number 12/576992 was filed with the patent office on 2010-04-29 for stabilizing a spinal anatomical structure.
This patent application is currently assigned to P TECH, LLC. Invention is credited to Peter M. Bonutti, Glen A. Phillips.
Application Number | 20100106194 12/576992 |
Document ID | / |
Family ID | 43857172 |
Filed Date | 2010-04-29 |
United States Patent
Application |
20100106194 |
Kind Code |
A1 |
Bonutti; Peter M. ; et
al. |
April 29, 2010 |
STABILIZING A SPINAL ANATOMICAL STRUCTURE
Abstract
Methods and devices for stabilizing spinal anatomical
structures. Some example methods may include introducing a curved
segment of an elongate fastener placement rod adjacent to a spinal
anatomical structure, providing a fastener at the leading end of
the curved segment, and/or securing the fastener in place with
respect to the spinal anatomical structure.
Inventors: |
Bonutti; Peter M.;
(Effingham, IL) ; Phillips; Glen A.; (Effingham,
IL) |
Correspondence
Address: |
TAFT, STETTINIUS & HOLLISTER LLP
SUITE 1800, 425 WALNUT STREET
CINCINNATI
OH
45202-3957
US
|
Assignee: |
P TECH, LLC
Effingham
IL
|
Family ID: |
43857172 |
Appl. No.: |
12/576992 |
Filed: |
October 9, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11258795 |
Oct 26, 2005 |
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12576992 |
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11358311 |
Feb 21, 2006 |
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11258795 |
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11202294 |
Oct 5, 2005 |
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11358311 |
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60622095 |
Oct 26, 2004 |
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60655140 |
Feb 22, 2005 |
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Current U.S.
Class: |
606/279 |
Current CPC
Class: |
A61B 17/0482 20130101;
A61B 17/1757 20130101; A61B 2017/2926 20130101; A61B 17/842
20130101; A61B 2017/0464 20130101; A61B 2017/0404 20130101; A61F
2/08 20130101; A61B 2017/00818 20130101; A61B 17/1615 20130101;
A61B 2017/00876 20130101; A61F 2210/0004 20130101; A61F 2310/00293
20130101; A61B 17/0467 20130101; A61F 2/442 20130101; A61F
2002/4435 20130101; A61B 17/0485 20130101; A61B 17/1675 20130101;
A61B 2017/00477 20130101; A61B 17/0483 20130101; A61B 2017/0488
20130101; A61B 17/1671 20130101; A61B 17/7053 20130101; A61B
17/8863 20130101; A61B 17/0469 20130101; A61B 17/0487 20130101;
A61B 17/683 20130101; A61B 2017/00004 20130101; A61F 2002/2817
20130101; A61B 17/17 20130101; A61B 2017/00893 20130101; A61B
2017/00898 20130101; A61B 2017/06176 20130101; A61B 17/00491
20130101; A61B 17/0401 20130101; A61B 17/8869 20130101; A61B
2017/0417 20130101; A61F 2002/30062 20130101; A61B 17/1637
20130101; A61B 2090/064 20160201; A61F 2310/00359 20130101; A61B
2017/0409 20130101; A61F 2002/30677 20130101; A61F 2002/444
20130101; A61B 17/0218 20130101; A61F 2/28 20130101; A61B 2017/0496
20130101 |
Class at
Publication: |
606/279 |
International
Class: |
A61B 17/88 20060101
A61B017/88 |
Claims
1. A method for stabilizing a spinal anatomical structure,
comprising: introducing, into a body, a curved segment of an
elongate, fastener placement rod approximate to, adjacent to or on
a spinal anatomical structure, the curved segment having a leading
end; providing, at the leading end of the curved segment of the
fastener placement rod, a fastener approximate to, adjacent to or
on the spinal anatomical structure; and securing the fastener with
respect to the spinal anatomical structure.
2. The method of claim 1, wherein the fastener is secured with
respect to the spinal anatomical structure utilizing at least one
flexible line.
3. The method of claim 2, wherein the at least one flexible line
extends from the fastener, through at least a portion of the spinal
anatomical structure to a separate securing point within the
body.
4. The method of claim 3, further comprising securing the at least
one flexible line at the separate securing point by a second
fastener.
5. The method of claim 4, wherein the step of securing the at least
one flexible line at the separate securing point by the second
fastener comprises crimping the second fastener to the flexible
line.
6. The method of claim 5, wherein the crimping step comprises
introducing a crimping mechanism extending from an elongate rod of
a crimping tool through an incision in the body and adjacent to the
second fastener.
7. The method of claim 3, wherein the at least one flexible line
comprises a suture.
8. The method of claim 3, wherein the at least one flexible line
comprises a cable.
9. The method of claim 2, wherein the flexible line is provided
attached to the fastener approximate to, adjacent to or on the
spinal anatomical structure, and the method includes a step of
passing the flexible line from the fastener and at least through
the portion of the spinal anatomical structure to the separate
securing point within the body.
10. The method of claim 9, wherein the passing step is performed
utilizing a gripper at a leading end of an elongate gripper rod
which pulls the flexible line from the fastener and at least
through the portion of the spinal anatomical structure to the
separate securing point within the body.
11. The method of claim 10, wherein the elongate fastener placement
rod and elongate gripper rod extend from a hand-held guidance and
positioning device.
12. The method of claim 11, further comprising forming a hole
through the portion of the spinal anatomical structure prior to the
pulling step.
13. The method of claim 12, wherein the hole forming step is
performed by an elongate drill rod extending from the hand-held
guidance and positioning device.
14. The method of claim 13, wherein the elongate gripper rod and
elongate drill rod are guided by a guide tube extending from the
hand-held guidance and positioning device.
15. The method of claim 10, wherein the elongate gripper rod
extends from the hand-held guidance and positioning device along an
axis that runs adjacent to or through the leading end of the curved
segment of the fastener placement rod.
16. The method of claim 9, further comprising forming a hole
through the portion of the spinal anatomical structure prior to the
passing step.
17. The method of claim 2, wherein the spinal anatomical structure
is a first spinal anatomical structure; the flexible line is
provided attached to the fastener approximate to, adjacent to or on
the spinal anatomical structure; and the method includes a step of
passing the flexible line from the fastener and at least through
the portion of the first spinal anatomical structure, through at
least a portion of a second anatomical structure to the separate
securing point within the body, thereby stabilizing at least the
first and second spinal anatomical structures with respect to each
other.
18. The method of claim 17, wherein the first spinal anatomical
structure is an intervertebral disc and the second spinal
anatomical structure is a vertebra.
19. The method of claim 17, wherein the first spinal anatomical
structure is a first vertebra and the second spinal anatomical
structure is a second vertebra.
20. The method of claim 17, wherein the first spinal anatomical
structure is a vertebra and the second spinal anatomical structure
is an intevertebral disc.
21. The method of claim 17, wherein the first spinal anatomical
structure is a first spinous process and the second spinal
anatomical structure is a second spinous process.
22. The method of claim 17, wherein the first spinal anatomical
structure is a first ligament segment and the second spinal
anatomical structure is a second ligament segment.
23. The method of claim 22, wherein the first and second ligament
segments are torn or severed segments of the same ligament.
24. The method of claim 17, wherein the first spinal anatomical
structure is a ligament and the second spinal anatomical structure
is a vertebra.
25. The method of claim 17, wherein the first spinal anatomical
structure is a ligament and the second spinal anatomical structure
is an intevertebral disc.
26. The method of claim 17, wherein the first spinal anatomical
structure is a vertebra and the second spinal anatomical structure
is a ligament.
27. The method of claim 17, wherein the first spinal anatomical
structure is an intervertebral disc and the second spinal
anatomical structure is a ligament.
28. The method of claim 17, wherein the method includes a step of
passing the flexible line from the fastener and at least through
the portion of the first spinal anatomical structure, through at
least a portion of a second anatomical structure, and through at
least a portion of a third anatomical structure to the separate
securing point within the body, thereby stabilizing at least the
first, second and third spinal anatomical structures with respect
to each other.
29. The method of claim 28, wherein at least two of the first,
second and third spinal anatomical structures comprise spinous
processes.
30. The method of claim 28, wherein at least two of the first,
second and third spinal anatomical structures comprise facets.
31. The method of claim 17, wherein the drawing step further
comprises passing the flexible line through an implant.
32. The method of claim 31, wherein the implant comprises a
graft.
33. The method of claim 31, wherein the implant comprises a disc
implant.
34. The method of claim 31, wherein the implant comprises a
scaffold.
35. The method of claim 17, wherein the first spinal anatomical
structure is a spinous process and the second spinal anatomical
structure is at least one of a pedicle and bone of a facet
joint.
36. The method of claim 17, wherein the first spinal anatomical
structure is at least one of a pedicle and bone of a facet joint
and the second spinal anatomical structure is a spinous
process.
37. The method of claim 17, wherein the first spinal anatomical
structure is a first side of a cervical spine and the second
anatomical structure is a second side of the cervical spine.
38. The method of claim 17, wherein the method further comprises
passing the flexible line through a tubular implant positioned
between the first and second spinal anatomical structures.
39. The method of claim 17, wherein the first spinal anatomical
structure is a first facet and the second spinal anatomical
structure is a second facet.
40. The method of claim 3, further comprising a step of tensioning
at least a portion of the flexible line extending between the
fastener and the separate securing point.
41. The method of claim 3, wherein the spinal anatomical structure
comprises annulus fibrosus.
42. The method of claim 3, wherein the spinal anatomical structure
comprises nucleus pulposus.
43. The method of claim 3, wherein the flexible line extends
through an intervertebral disc and through an adjacent
vertebra.
44. The method of claim 3, wherein the flexible line extends
through adjacent vertebrae and an intervertebral disc between the
adjacent vertebrae.
45. The method of claim 3, wherein the flexible line extends
through two vertebrae and a disc positioned between but not
adjacent to each of the two vertebrae.
46. The method of claim 3, wherein the flexible line extends
through an upper spinous process and through a lower spinous
process.
47. The method of claim 3, wherein the flexible line extends
through a vertebra and to or though a disc implant.
48. The method of claim 3, wherein the flexible line extends
through the spinal anatomical structure to or through a graft.
49. The method of claim 3, wherein the flexible line extends
through the spinal anatomical structure and through or to a disc
implant or a vertebral implant.
50. The method of claim 49, wherein the spinal anatomical structure
comprises annulus fibrosus.
51. The method of claim 49, wherein the spinal anatomical structure
comprises a vertebra.
52. The method of claim 49, wherein the spinal anatomical structure
comprises a facet.
53. The method of claim 3, wherein the flexible line extends
through two severed portions of a spinal ligament.
54. The method of claim 3, wherein the flexible line extends
through two portions of a spinal ligament.
55. The method of claim 54, wherein the flexible line further
extends through a vertebra adjacent to at least one of the two
portions of the spinal ligament.
56. The method of claim 54, wherein the flexible line further
extends through an intervertebral disc.
57. The method of claim 3, wherein the flexible line extends to or
through a stabilization rod or plate.
58. The method of claim 57, wherein the spinal anatomical structure
is a spinous process.
59. The method of claim 3, wherein the flexible line extends
through at least one portion of a spinal ligament and through or to
a ligament graft.
60. The method of claim 1, wherein at least a portion of the
elongate fastener placement rod is hollow.
61. The method of claim 60, wherein the portion of the elongate
fastener placement rod that is hollow opens onto the leading end of
the curved segment of the fastener placement rod.
62. The method of claim 61, wherein the step of providing, at the
leading end of the curved segment of the fastener placement rod, a
fastener approximate to, adjacent to or on the spinal anatomical
structure, includes a step of sending the fastener through the
portion of the elongate faster placement rod that is hollow to the
leading end of the curved segment.
63. The method of claim 62, wherein sending step further comprises
sending a flexible line with the fastener through the portion of
the elongate fastener placement rod that is hollow to the leading
end of the curved segment, wherein the fastener is secured in place
utilizing at least a portion of flexible line.
64. The method of claim 1, wherein the step of providing, at the
leading end of the curved segment of the fastener placement rod, a
fastener approximate to, adjacent to or on the spinal anatomical
structure, is preceded by a step of engaging the fastener with the
leading end of the curved segment of the fastener placement
rod.
65. The method of claim 1, further comprising a step of engaging
the fastener with the leading end of the curved segment of the
fastener placement rod.
66. The method of claim 65, wherein the engaging step includes a
step of disposing at least a portion of the fastener within the
leading end of the curved segment of the fastener placement
rod.
67. The method of claim 65, further comprising a step of
disengaging the fastener from the leading end of the curved segment
of the fastener placement rod while the fastener is approximate to,
adjacent to or on the spinal anatomical structure.
68. The method of claim 1, wherein the introducing step comprises
introducing the curved segment of an elongate, fastener placement
rod through an incision in the skin as part of a minimally invasive
procedure.
69. The method of claim 1, wherein the spinal anatomical structure
comprises at least one of bone, vertebral body, nucleus pulposus,
muscle, tendon and cartilage.
70. The method of claim 1, wherein the spinal anatomical structure
comprises at least one bone taken from a group consisting of:
transverse process, pedicle, facet, spinous process, posterior
arch, odontoid process, posterior tubercle, lateral articular
process, uncinate process, anterior tubercle, carotid tubercle,
odontoid process, lamina and vertebral body.
71. The method of claim 1, wherein the spinal anatomical structure
comprises at least one ligament taken from a group consisting of:
anterior longitudinal ligament, posterior longitudinal ligament,
interspinous ligament, supraspinous ligament, ligamentum flavum,
intertransverse ligament, facet capsulary ligament, ligamentum
nuchae, ligament of the sacrum and ligament of the coccyx
spine.
72. A method for stabilizing a spinal anatomical structure,
comprising: connecting a flexible line and a fastener; introducing,
through an incision in the body, a curved segment of an elongate,
fastener placement rod approximate to, adjacent to or on a spinal
anatomical structure, the curved segment having a leading end;
providing, at the leading end of the curved segment of the fastener
placement rod, the fastener and attached flexible line at a
fastener placement point that is approximate to, adjacent to or on
the spinal anatomical structure, the providing step including
passing the fastener and attached flexible line through the curved
segment of the elongate fastener placement rod to the leading end;
passing the connected flexible line from approximate the fastener
placement point through at least a portion of the spinal anatomical
structure to a securing point; tensioning the flexible line between
the fastener placement point and the securing point; and securing
the flexible line at the securing point.
73. The method of claim 72 wherein the step of securing the
flexible line at the securing point comprises a step of tying the
flexible line.
74. The method of claim 72 wherein the step of securing the
flexible line at the securing point comprises a step of fastening
the flexible line at the securing point using another fastener.
75. The method of claim 74 wherein the step of fastening the
flexible line at the securing point using another fastener
comprises crimping the other fastener to the flexible line.
76. The method of claim 72 wherein the flexible line comprises a
suture.
77. The method of claim 72 wherein the flexible line comprises a
cable.
78. The method of claim 72 wherein the passing step is performed
utilizing a gripper at a leading end of an elongate gripper rod to
pull the connected flexible line from approximate the fastener
placement point through at least the portion of the spinal
anatomical structure to the securing point.
79. The method of claim 78 wherein the elongate fastener placement
rod and the elongate gripper rod extend from a hand-held guidance
and positioning device.
80. The method of claim 79 further comprising forming a hole
through the portion of the spinal anatomical structure prior to the
pulling step.
81. The method of claim 80 wherein the hole forming step is
performed by an elongate drill rod extending from the hand-held
guidance and positioning device.
82. The method of claim 81 wherein the elongate gripper rod and the
elongate drill rod are guided by a guide tube extending from the
hand-held guidance and positioning device.
83. The method of claim 72, wherein the spinal anatomical structure
comprises annulus fibrosus.
84. The method of claim 72, wherein the flexible line extends
through an intervertebral disc and through an adjacent
vertebra.
85. The method of claim 72, wherein the flexible line extends
through adjacent vertebrae and an intervertebral disc between the
adjacent vertebra.
86. The method of claim 72, wherein the flexible line extends
through two vertebrae and a disc positioned between but not
adjacent to each of the two vertebrae.
87. The method of claim 72, wherein the flexible line extends
through an upper spinous process and through a lower spinous
process.
88. The method of claim 72, wherein the flexible line extends
through a vertebra and to or though a disc implant.
89. The method of claim 72, wherein the flexible line extends
through the spinal anatomical structure to or through a graft.
90. The method of claim 72, wherein the flexible line extends
through the spinal anatomical structure and through or to a disc
implant or a vertebral implant.
91. The method of claim 90, wherein the spinal anatomical structure
comprises annulus fibrosus.
92. The method of claim 90, wherein the spinal anatomical structure
comprises a vertebra.
93. The method of claim 90, wherein the spinal anatomical structure
comprises a facet.
94. The method of claim 72, wherein the flexible line extends
through two severed portions of a spinal ligament.
95. The method of claim 72, wherein the flexible line extends
through two portions of a spinal ligament.
96. The method of claim 95, wherein the flexible line further
extends through a vertebra adjacent to at least one of the two
portions of the spinal ligament.
97. The method of claim 95, wherein the flexible line further
extends through an intervertebral disc.
98. The method of claim 72, wherein the flexible line extends to or
through a stabilization rod or plate.
99. The method of claim 98, wherein the spinal anatomical structure
is a spinous process.
100. The method of claim 72, wherein the flexible line extends
through at least one portion of a spinal ligament and through or to
a ligament graft.
101. The method of claim 72, wherein the spinal anatomical
structure is a first spinal anatomical structure; and the method
comprises a step of passing the flexible line from approximate the
fastener and at least through the portion of the first spinal
anatomical structure, through at least a portion of a second
anatomical structure to the securing point, thereby stabilizing at
least the first and second spinal anatomical structures with
respect to each other.
102. The method of claim 101, wherein the first spinal anatomical
structure is an intervertebral disc and the second spinal
anatomical structure is a vertebra.
103. The method of claim 101, wherein the first spinal anatomical
structure is a first vertebra and the second spinal anatomical
structure is a second vertebra.
104. The method of claim 101, wherein the first spinal anatomical
structure is a vertebra and the second spinal anatomical structure
is an intevertebral disc.
105. The method of claim 101, wherein the first spinal anatomical
structure is a first spinous process and the second spinal
anatomical structure is a second spinous process.
106. The method of claim 101, wherein the first spinal anatomical
structure is a first ligament segment and the second spinal
anatomical structure is a second ligament segment.
107. The method of claim 106, wherein the first and second ligament
segments are torn or severed segments of the same ligament.
108. The method of claim 101, wherein the first spinal anatomical
structure is a ligament and the second spinal anatomical structure
is a vertebra.
109. The method of claim 101, wherein the first spinal anatomical
structure is a ligament and the second spinal anatomical structure
is an intevertebral disc.
110. The method of claim 101, wherein the first spinal anatomical
structure is a vertebra and the second spinal anatomical structure
is a ligament.
111. The method of claim 101, wherein the first spinal anatomical
structure is an intervertebral disc and the second spinal
anatomical structure is a ligament.
112. The method of claim 101, wherein the method includes a step of
passing the flexible line from the fastener and at least through
the portion of the first spinal anatomical structure, through at
least a portion of a second anatomical structure, and through at
least a portion of a third anatomical structure to the separate
securing point within the body, thereby stabilizing at least the
first, second and third spinal anatomical structures with respect
to each other.
113. The method of claim 112, wherein at least two of the first,
second and third spinal anatomical structures comprise spinous
processes.
114. The method of claim 112, wherein at least two of the first,
second and third spinal anatomical structures comprise facets.
115. The method of claim 101, wherein the passing step further
comprises passing the flexible line through an implant.
116. The method of claim 115, wherein the implant comprises a
graft.
117. The method of claim 115, wherein the implant comprises a disc
implant.
118. The method of claim 115, wherein the implant comprises a
scaffold.
119. The method of claim 101, wherein the first spinal anatomical
structure is a spinous process and the second spinal anatomical
structure is at least one of a pedicle and bone of a facet
joint.
120. The method of claim 101, wherein the first spinal anatomical
structure is at least one of a pedicle and bone of a facet joint
and the second spinal anatomical structure is a spinous
process.
121. The method of claim 101, wherein the first spinal anatomical
structure is a first side of a cervical spine and the second
anatomical structure is a second side of the cervical spine.
122. The method of claim 101, wherein the method further comprises
passing the flexible line through a tubular implant positioned
between the first and second spinal anatomical structures.
123. The method of claim 101, wherein the first spinal anatomical
structure is a first facet and the second spinal anatomical
structure is a second facet.
124. A method for stabilizing a spinal anatomical structure,
comprising: a step for introducing a fastener approximate to,
adjacent to or on a spinal anatomical structure using a curved end
of an introducer means; a step for passing a flexible line attached
to the fastener through at least a portion of the spinal anatomical
structure to a securing point; and a step for securing the flexible
line at the securing point.
125. The method of claim 124 further comprising a step for
tensioning the flexible line between the fastener and the securing
point.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of prior
application Ser. No. 11/258,795, filed Oct. 26, 2005, which claims
the benefit of U.S. Provisional Application No. 60/622,095, filed
Oct. 26, 2004; is a continuation-in-part of prior application Ser.
No. 11/358,311, filed Feb. 21, 2006, which claims the benefit of
U.S. Provisional Application No. 60/655,140, filed Feb. 22, 2005;
and is a continuation of prior application Ser. No. 11/202,294,
filed Oct. 5, 2005; all of which are incorporated by reference.
BACKGROUND
[0002] The present disclosure is directed to surgical repair,
stabilization, and/or fixation of tissue and/or implants. More
specifically, the present disclosure pertains to guiding,
positioning, repairing, reconstructing, augmenting, stabilizing,
and/or fixing surgical devices, implants, tissues, within the
body.
[0003] In the medical arts, physicians use various methods and
devices to attach soft tissue to other soft tissue, soft tissue to
hard tissue, and hard tissue to other hard tissue. These same or
similar techniques and devices are also used to position or fix an
implant within the body. Such implants may include bone plates,
fasteners, stents, filters, drug eluting implants, tissue alignment
members, organ transplants, tissue scaffolding, tissue grafts,
intervertebral disc replacement components, nucleus pulposus
replacement component, and other joint replacements components,
prostheses, robotic components, nanotechnology devices, sensors,
emitters, radiofrequency emitting diodes, computer chips, RFID
(radiofrequency identification) tags, adhesives, and sealants.
[0004] Applying pressure or compression to tissue and/or an implant
helps during the healing process. Incised or torn soft tissue, for
example, may be approximated with bandages, sutures, or staples.
Proper and more rapid healing of broken or fractured bones likewise
may be facilitated by applying constant pressure to the bone. For
instance, physicians may insert pins, screws, or bolts in the area
of the fracture in order to apply compression and stabilization to
the fracture.
[0005] However, inserting screws through or around fractures can be
complex and time-consuming. For example, the process of inserting a
screw typically involves multiple steps conducted from multiple
incisions or openings that provide access to the treated bone or
tissue, including the steps of drilling holes, measuring the
relevant distances to determine the appropriate screw selection,
tapping the hole to establish threads, and screwing the screw into
the hole.
[0006] In addition to the length and complexity of the process,
bone screws also may lose their grip and strip out of the bone.
Also, currently available lag screws typically provide only one
side of cortex fixation and are generally not suited for
percutaneus surgery. Moreover, when placing the screws in the bone,
the physician may not accurately set the screw into the distal hole
or may miss the distal hole completely, thereby resulting in the
screw stripping the threads or breaking the bone.
[0007] Many devices and instruments have been disclosed to fasten
soft and hard tissue for enhanced healing or tissue reconstruction.
Examples of such devices include bone plates, bone wraps, external
bone supports, and the like.
[0008] For example, U.S. Pat. No. 4,257,411 to Cho discloses a
surgical drill guide tool adapted to be temporarily mounted about a
distal portion of the femur for drilling a bony tunnel through a
portion of the femur. The surgical tool allows for very precise
location of the drill exit within the intercondylar notch, which is
often critical in proper reconstruction of the anterior cruciate
ligament of the knee. The surgical tool drill guide is
characterized by having a first and second upright, with first and
second drill sheaths located at their respective distal ends
wherein transverse mounting means are provided to allow the surgeon
to position the first and second drill sheaths tightly against
opposite surfaces of the femur to provide a continuing and exact
alignment for the drilling of the bony tunnel. The drill sheath at
the distal end of the second upright is configured to fit inside
the intercondylar notch, and allow exact placement of the exit of a
bony tunnel which is drilled extra-articularly through the skin,
and through the lateral femoral condyle.
[0009] U.S. Pat. No. 4,922,897 to Sapega et al. discloses a method
and apparatus for the permanent surgical reconstruction of the
anterior cruciate ligament in the human knee, which will stabilize
the tibia and femur relative to each other and restore a full range
of motion to the knee, by precisely locating the ends and angular
relationship of a replacement ligament within the knee joint, at
bone attachment sites such that the degree of shortening and
lengthening experienced by the replacement ligament over the range
of joint motion is either as close to zero (isometric) as possible,
or closely matches that of the natural uninjured ligament
(physometric), whichever the surgeon feels is most desirable.
[0010] U.S. Pat. No. 5,573,538 to Laboureau discloses ancillary
instruments for the reconstruction of a posterior cruciate knee
ligament by drilling one or two tibial canals using a surgical
operation performed from the front. The instrument set includes a
system for protecting the posterior surface of the upper tibia end
and an aiming device for guiding at least one drill. The protection
system includes at least one bent tube removably coupled by an
extension portion to a locking handle for securing the tube through
the intercondylar fossa of the femur on the posterior surface of
the upper end of the tibia, so that the distal end of the bent tube
serves as the stop to the drill guided by the aiming device and
emerging from the tibial bone canal, and the bent tube can form,
together with a rectilinear wire feed-through tube disposed in the
place of the drill, a continuous canal for guiding a metallic loop
used to draw the prosthetic posterior cruciate knee ligament from
the anterior surface of the tibia to the femur insertion point.
[0011] U.S. Patent Publication No. 2003/0216742 to Wetzler et al.
discloses a surgical drill guide generally including a handle
connected to an arm with an end that contacts bone. The handle has
a plurality of non-parallel channels therein for receiving a sleeve
at different angles. Once properly positioned, the sleeve can be
used to guide a K-wire into the bone, which can then be used as a
guide for drilling a tunnel. The various angles allow the surgeon
to achieve a range of tunnel lengths. In some embodiments, the
guide has a locking mechanism for locking the sleeve in the
channels.
[0012] Accordingly, a need exists for a method and device which can
provide guided positioning and flexible or rigid fixation of tissue
and/or an implant within the body while accessing the procedure
site from a small skin portal.
[0013] During a surgical procedure, tissue is either intentionally
or accidentally displaced, torn, or fractured to create a pathway
to a desired operation site. In doing so, this tissue is damaged to
a point where it may not function properly. After the intended
surgical procedure or implantation is performed at the operation
site, the skin incision is approximated. Currently, however, the
other tissue like the muscles, ligaments, tendons, cartilage,
bones, etc. which were damaged to create the pathway are not
necessarily repaired or reconstructed. For example, following
spinal surgery, a frequent complication is late instability where
there is shearing antero-posteriorly or superior inferiorly due to
excess motion because the ligaments have been damaged during
surgical exposure. This complication may lead to degenerative disc
disease and lower back pain.
[0014] Various methods and devices have been disclosed for
repairing tissue. For example, U.S. Pat. No. 6,425,919 issued to
Lambrecht discloses a disc herniation constraining device for
implantation into the disc. The constraining device includes a
fastener, a barrier, and a support member connecting the fastener
and barrier. The barrier closes a defect in the annulus of the
disc, while the fastener supports the position of the barrier. The
barrier is placed between the annulus and the nucleus of the disc.
The barrier may include a sealant and an enlarger.
[0015] In another example, U.S. Pat. No. 6,592,625 issued to
Cauthen discloses a collapsible patch which is inserted through a
surgical incision or rupture of the annulus. The patch is
positioned within the subannular space. The patch expands to bridge
the incision or rupture thereby occluding the aperture from the
interior of the disc and preventing migration of nucleus
pulposus.
[0016] U.S. Pat. No. 6,679,889 issued to West, Jr. et al discloses
a method and apparatus of repairing the anterior cruciate ligament.
The device enables the surgeon to independently apply a desired
tensile load onto individual strands of a multiple-stranded soft
tissue graft. The device is equipped with structure for fastening
or otherwise attaching the device to a patient's limb during the
conditioning and pre-tensioning procedure.
[0017] Additionally, U.S. Pat. No. 6,699,286 issued to Sklar
discloses methods and apparatus of making repairs with graft
ligaments. The method for graft ligament reconstruction includes
harvesting a graft ligament consisting entirely of soft tissue. The
graft ligament is compacted through compression so as to
significantly reduce the cross-sectional area and increase the
density of the collagen material of the graft ligament. The
compressed graft ligament is deployed within the human body.
[0018] Various methods and devices have been disclosed for
inserting an implant within the body. For example, U.S. Pat. No.
5,108,438 issued to Stone discloses a mesh skirt to anchor a
prosthetic intervertebral disc. The implant includes a dry, porous,
volume matrix of biocompatible and bioabsorbable fibers which may
be interspersed with glyscosaminoglycan molecules. The matrix is
adapted to have an outer surface contour substantially the same as
that of a natural intervertebral disc. A mesh member extends from
the lateral surface of the implant. After implantation, the mesh
member may be sutured to adjacent tissue to anchor the disc in
place. The mesh member may function in this capacity until
sufficient tissue ingrowth occurs to provide that function.
[0019] In another example, U.S. Pat. No. 6,733,531 issued to Trieu
discloses a spinal implant which is anchored using a device having
an elongated anchoring body, such as an anchoring rod, and at least
one securing member attached to the anchoring rod. The anchoring
body or rod is configured to anchor, hold, or otherwise retain a
spinal implant. The securing members are spaced apart along the
length of the anchoring rod and may define a region for disposing
an implant therebetween. The anchoring rod has a first end and a
second end, wherein the first end is securable to an adjacent
vertebra.
[0020] Once tissue has been repaired or an implant has been
inserted within the body, the repaired region and surrounding
tissue may be stabilized to enhance healing. U.S. Pat. No.
6,652,585 issued to Lange discloses a spine stabilization system
including a flexible member attachable to a portion of the spinal
column. The member includes components that are oriented and
function similar to the natural fiber orientation of the anterior
longitudinal ligament and annulus tissue. The use of components
resist loading applied by extension and rotation of the spine,
while the flexibility of the member does not subject it to the
compressive loading of the spinal column segment to which it is
attached.
[0021] In addition, U.S. Pat. No. 6,293,949 issued to Justis et al.
discloses a device for stabilizing the spinal column. The device
includes a longitudinal member sized to span a distance between at
least two vertebral bodies and being at least partially formed of a
shape-memory material exhibiting pseudoelastic characteristics at
about human body temperature. The longitudinal member is reformed
from an initial configuration to a different configuration in
response to the imposition of stress caused by relative
displacement between the vertebral bodies, and recovers toward the
initial configuration when the stress is removed to thereby provide
flexible stabilization to the spinal column.
[0022] There exists a need for devices and methods for repairing,
reconstructing, augmenting, and securing tissue or an implant
during surgery and "on the way out" after surgery has been
performed at an intended operation site. Upon completion of the
intended surgery, tissue may be compressed to other tissue or an
implant to improve healing. Hard tissue, for example, may require
rigid fixation while soft tissue to require flexible fixation. The
repair, reconstruction, and augmentation of tissue and the securing
of implants "on the way out" of the body after performing a
surgical procedure creates a stabilized and enhanced healing
environment.
[0023] It is well-known in the medical arts that applying pressure
to tissue helps during the healing process. Incised or torn soft
tissue, for example, may be approximated with bandages, sutures, or
staples. Proper and more rapid healing of broken or fractured bones
likewise may be facilitated by applying constant pressure to the
bone. For instance, physicians may insert pins, screws, or bolts in
the area of the fracture in order to apply pressure to the
fracture.
[0024] However, inserting screws through or around fractures can be
complex and time-consuming. For example, the process of inserting a
screw typically involves multiple steps conducted from multiple
incisions or openings that provide access to the treated bone or
tissue, including the steps of drilling holes, measuring the
relevant distances to determine the appropriate screw selection,
tapping the hole to establish threads, and screwing the screw into
the hole.
[0025] In addition to the length and complexity of the process,
bone screws also may lose their grip and strip out of the bone. In
addition, currently available lag screws also typically provide
only one side of cortex fixation and are generally not suited for
percutaneous surgery. Moreover, when placing the screws in the
bone, the physician may not accurately set the screw into the
distal hole or may miss the distal hole completely, thereby
resulting in the screw stripping the threads or breaking the
bone.
[0026] Many devices and instruments have been disclosed to fasten
soft and hard tissue for enhanced healing or tissue reconstruction.
Examples of such devices include bone plates, bone wraps, external
bone supports, and the like.
[0027] For example, U.S. Pat. No. 5,921,986, the contents of which
are incorporated herein by reference, discloses a bone suture and
associated methods for implantation and fracture fixation. The '986
Patent describes fasteners and anchors used in conjunction with an
elongate fixation element, such as a suture. In some cases, it may
be advantageous to use more rigid fixation elements.
[0028] Accordingly, a need exists for a tissue fixation instrument
which can provide flexible or rigid fixation of tissue while
accessing the tissue from a small skin portal.
SUMMARY
[0029] The present disclosure includes instruments and methods for
guiding and positioning various implants within the body. The
instrument may provide for the placement of a biocompatible implant
within tissue and/or may provide for dynamic and rigid fixation of
tissue. An implant guidance and positioning device includes a body
member connected with a hook. The hook may have a lumen extending
therethrough. The device also includes a guide channel disposed in
the body member. The longitudinal axis of the guide channel may be
generally aligned with or slightly offset from a distal end of the
hook. The device may further include a pushrod for positioning a
fastener and suture in the lumen of the hook. Furthermore, the
device may include an elongated claw dimensioned for insertion
through the guide channel. The claw may include means for grabbing
the suture.
[0030] In another embodiment, the positioning device includes a
body member, an elongated member connected with the body member, a
socket member connected to the distal end of the elongated member,
and a guide slot disposed in the body member. The longitudinal axis
of the guide slot is generally aligned with or slightly offset with
the socket member. The socket member may be dimensioned and
configured for holding a fastener. The device may also include a
fastening member dimensioned for insertion in the guide slot. The
fastening member may include means for attaching the fastening
member to the fastener, such as threads, ribs, magnets, adhesives,
or expandable material.
[0031] In a related aspect of the present invention, the distal
portion of the hook or elongated member is curved to be
positionable at least partially on the distal or backside of the
bone or tissue, while the proximal portion of the hook or elongated
member may be generally parallel with the guide channel or slot.
The hook or elongated member may be removably connected with the
body member with means for holding and releasing the hook or
elongated member.
[0032] The positioning device may further include a drill system
having a drill bit dimensioned for insertion through the guide
channel or slot. The drill system may create a linear or non-linear
passage in tissue. The drill system may be a cannulated drill
system. The positioning device may also include means for clamping
the device to tissue. Such means may include a threaded tube
adjustably attached to the body member, a tube and a finger grip
attached to the body member, or one or more pins placed between the
positioning device and tissue. Furthermore, the device may include
a tensioning mechanism for tensioning the suture or fastening
member.
[0033] The present disclosure includes the repair, reconstruction,
augmentation, and securing of tissue or implants during a surgical
procedure and "on the way out" after the surgical procedure has
been performed. Hard and soft tissue at and around the operation
site and tissue between the operation site and the skin incision
may be compressed and/or rebuilt so that tissue-function may be at
least partially restored and the operation region may be stabilized
for enhanced healing. This could be ligament repair, tendon repair,
muscle repair, bone repair, cartilage repair, and repair of any
other tissue type. Ligaments may be fastened to ligaments;
ligaments to bones; bones to bones; ligaments to muscles; muscles
to muscles; tissue grafts to bone; tissue grafts to ligaments;
grafts to grafts; and any other combination of tissue and implants.
It is further contemplated that the methods and devices of the
present invention may be utilized with minimally invasive
techniques.
[0034] In accordance with one aspect of the present invention, a
method for stabilizing a body joint is provided. A fastener is
positioned in contact with first body tissue on one side of the
joint. Another fastener is positioned in contact with second body
tissue on the other side of the joint. A suture is placed between
the fasteners and tensioned. The tensioned suture is secured to the
fasteners to restrict normal movement of the joint. The fasteners
may be positioned in contact with the outer surface of the body
tissues or inside of the body tissues. The suture may be positioned
adjacent to the joint, through the joint, or in combination.
[0035] The body tissues may be bones, muscles, ligaments, tendons,
nerves, skin, organs, cartilage, fascia, and blood vessels. The
bones and ligaments may be bones and ligaments of the knee, ankle,
elbow, wrist, feet, hand, hip, shoulder, jaw, and spine.
Specifically, bones of the knee may include the femur, tibia, and
patella. Ligaments of the knee may include the medial collateral
ligament, lateral collateral ligament, posterior oblique ligament,
arcuate ligament, oblique popliteal ligament, anterior cruciate
ligament, and posterior cruciate ligament. Bones of the spine may
include transverse process, pedicle, facet, spinous process,
posterior arch, odontoid process, posterior tubercle, lateral
articular process, uncinate process, anterior tubercle, carotid
tubercle, odontoid process, lamina, and vertebral body. Ligaments
of the spine may include the anterior longitudinal ligament,
posterior longitudinal ligament, interspinous ligaments,
supraspinous ligament, ligamentum flavum, intertransverse ligament,
facet capsulary ligament, ligamentum nuchae, and ligaments of the
sacrum and coccyx spine. Such bones of the spine and ligaments of
the spine (as well as all other body tissues associated with the
spine) may be referred to as spinal anatomical structures.
[0036] A tubular member may be positioned between the fasteners,
and the suture may be placed within the tubular member such that a
portion of the tubular member contacts the first body part and
another portion of the tubular member contacts the second body part
thereby maintaining the body parts in alignment with each
other.
[0037] In accordance with another aspect of the present invention,
there is provided a method for approximating an incision in tissue.
A suture is positioned in portions of tissue located on opposite
sides of the incision. The proximal and distal ends of the suture
extend from the tissue and are adjacent the incision. A fastener is
placed transverse to the incision with the ends of the suture
disposed within at least one channel of the fastener. The suture is
tensioned and secured to the fastener to thereby approximate the
incision. The tissue may be bone, muscle, ligament, tendon, skin,
organ, cartilage, and blood vessels.
[0038] Additionally, two fasteners may be positioned generally
parallel to an incision with the first fastener placed on one side
of the incision and the second fastener placed on the opposite side
of the incision. A suture may be positioned in portions of tissue
located on opposite sides of the incision with the middle section
of the suture slidably disposed within at least one channel of the
first fastener and the end portions of the suture disposed within
at least one channel of the second fastener. The suture may be
tensioned and secured to the fasteners to thereby approximate the
incision.
[0039] In accordance with another aspect of the present invention,
a fastener is provided. The fastener includes an elongated member
and at least one channel extending therethrough generally
perpendicular to the longitudinal axis of the elongated member. A
portion of the outer surface of the fastener may be concave, flat,
and/or convex.
[0040] There is also provided a method of using a fastener. At
least a portion of the surface of the fastener is placed in contact
with tissue. The fastener may be placed in contact with an outer
surface of the tissue and/or the inner portion of the tissue. A
portion of the surface of the fastener may be flat, convex, or
concave. A convex portion of the fastener may be placed in contact
with a concave portion of the tissue. A flat portion of the
fastener may be placed in contact with a flat portion of the
tissue. A concave portion of the fastener may be placed in contact
with a convex portion of the tissue. In these configurations, the
shaped portions of the fasteners mate with the tissue.
[0041] In accordance with yet another aspect of the present
invention, a fastener assembly is provided. The assembly includes a
plurality of fastener members, each fastener member having at least
one channel extending therethrough. A plurality of connecting
members links the fastener members to each other. The fastener
members may be linked together end to end, side to side, or end to
side. When linked together, the fastener members may form a linear,
circular, rectangular, J, L, or U configuration. The connecting
members may be hinges, pins, ball and socket, interconnecting
loops, hooks, flexible filaments and/or rigid members. There may be
two or more connecting members which link adjacent fastener
members. The channels of the fastener members may be generally
transverse to the longitudinal axis of the fastener member. Each
fastener member may include two or more channels, and the channels
may be generally parallel to each other.
[0042] Furthermore, a fastener strip or assembly is provided. The
fastener strip or assembly includes a plurality of fastener members
disposed on a flexible strip. Each fastener member has at least one
channel extending therethrough. The channel may be generally
transverse to the longitudinal axis of the fastener member. The
fastener members are positioned on the flexible strip to form a
linear, circular, rectangular, J, L, and/or U configuration. The
fastener members may be affixed to the upper surface of the
flexible strip. The fastener members may be affixed to the upper
surface of the flexible strip with adhesive. The flexible strip may
also have adhesive on its lower or bottom surface for adhesion to
tissue. Such adhesives may include cyanoacrylate adhesives,
hydrogel adhesives, monomer and polymer adhesives, fibrin,
polysaccharide, Indermil.RTM. or any other biocompatible adhesive.
The flexible strip may be bioabsorbable, bioerodible, degradable,
biodegradable, expandable, and/or hydrophilic.
[0043] There is also provided a method for using a fastener
assembly. The fastener assembly is positioned against tissue. A
suture or sutures are positioned within the tissue and through the
suture assembly to secure the assembly to the tissue. In one
embodiment, the assembly is placed over an incision in the tissue.
The fastener members are positioned such that channel of the
fastener members are located on each side of the incision. A suture
or sutures are positioned within the portions of tissue on opposite
sides of the incision and through the fastener assembly. The suture
or sutures are tensioned and secured with the fastener members. The
type and configuration of the fastener assembly is determined with
respect to the shape or configuration of the tissue. The shape of
the incision also determines the shape of the fastener
assembly.
[0044] In accordance with a further aspect of the present
invention, a total disc replacement implant is provided. The
implant includes a superior or upper portion made of a rigid
material. The upper surface of the superior portion is configured
to adjoin to a cut portion of a superior or upper vertebra. The
implant also includes an inferior or lower portion made of a rigid
material. The lower surface of the inferior portion is configured
to adjoin to a cut portion of an inferior or lower vertebra. The
implant further includes a middle portion made of a flexible
material. The middle portion is affixed to the lower surface of the
superior portion and the upper surface of the inferior portion.
[0045] The superior and inferior portions of the implant may
include polymeric, composite, metallic, ceramic, and expandable
material. The portions may also include synthetic bone and body
tissue like bone, collagen, cartilage, and ligaments. The portions
may also be bioabsorbable, bioerodible, degradable, and
biodegradable. The middle portion of the implant may include
rubber, gel, foam, polymer, collagen, and body tissue. The total
disc replacement implant may be made of a plurality of components;
that is, the implant may be modular. The components may be
connected with each other to form the implant. The components may
mechanically interlock with one another. Each component may have a
size approximately the same as the length of the incision through
which the components are inserted.
[0046] In addition, there is provided a method for total disc
replacement. An incision is made through tissue for access to the
spine. The dimensions of the incision may be minimized to reduce
trauma to surrounding tissue like muscle, ligaments, tendons, and
cartilage. The vertebra located superior to the damaged disc being
replaced is cut. The cut may be made on the lower or bottom portion
of the superior vertebra. The cut may be planar or multiplanar. The
superior vertebra may be cut without disturbing or at least
minimally disturbing the adjacent ligaments, cartilage, and
muscles. The cut may be angled to avoid damaging or loosening the
spinal ligaments like the anterior and posterior longitudinal
ligaments.
[0047] The vertebra located inferior to the disc being removed is
cut in a similar manner, except the upper surface of the inferior
vertebra is cut. Once cut, the cut portions of vertebrae and the
intervertebral disc are removed through the incision. The cut
vertebrae are further prepared for receiving an implant. The total
disc replacement implant or modular implant is positioned between
the cut superior and inferior vertebrae. A modular implant may be
positioned one component at a time or already assembled. The
implant is anchored to the surrounding tissue like the adjacent
vertebral bodies. Any ligaments, muscles, cartilage, tendons, or
other body tissue cut or damaged during the procedure is repaired
prior to closing the incision. Finally, the incision is
approximated.
[0048] In accordance with another aspect of the present invention,
a tissue alignment sleeve is provided. The sleeve includes a
tubular member having a wall. The interior surface of the wall is
generally smooth. The exterior surface of the wall includes means
for gripping and creating friction. The gripping means may include
threads, a plurality of raised regions, and a plurality of
circumferential elevated areas or rings. The wall may include a
plurality of openings for tissue ingrowth and outgrowth. The wall
may include one or more longitudinal slits such that the tubular
member or sleeve may be bendable to increase and decrease the
diameter of the sleeve.
[0049] There is further provided a method of using a tissue
alignment sleeve. A channel is created in tissue. The sleeve is
positioned within the tissue. The gripping or friction means of the
sleeve holds the sleeve within the tissue. The tissue may include
first and second portions. When positioned within the first and
second portions of the tissue, the portions are aligned and
maintained in position relative to each other. The first and second
portions may be portions of bone on opposite sides of a fracture.
The portions may be tissue of a body joint. The portions may be
bones of a joint located on opposite sides of the joint, such that
when the sleeve is positioned, movement of the joint is
restricted.
[0050] A sleeve with at least one longitudinal slit may be
positioned with the channel created in tissue. The diameter of the
sleeve may be decreased by closing the gap in the longitudinal
slit. In a decreased diameter, the sleeve may be inserted into the
channel. Once positioned, the diameter of the sleeve may be
increased thereby engaging the gripping means with the tissue. A
suture or sutures may be placed through the lumen of the sleeve to
secure tissue located at the ends of the sleeve. After the sleeve
has gripped the adjacent tissue with the gripping means,
therapeutic substances or graft material (autogenic, allogenic,
xenogenic, or synthetic) may be packed into the tubular member.
[0051] In accordance with a further aspect of the present
invention, a method for stabilizing an implant is provided. A first
fastener is positioned in contact with tissue located adjacent the
implant. A second fastener is positioned in contact with tissue
located adjacent the implant generally opposite the first fastener.
A suture is placed between the fasteners and in contact with the
implant. The suture is tensioned, and the fasteners are secured to
the tensioned suture such that the suture transmits force to the
implant. The suture may be positioned in contact with the surface
of the implant. The suture may also be positioned within the
implant.
[0052] In addition, a method for stabilizing an implant within a
body is provided. A first fastener is positioned in contact with
the implant. A second fastener is positioned in contact with tissue
located adjacent the implant. A suture is placed between the
fasteners. The suture is tensioned, and the fasteners are secured
to the tensioned suture to anchor the implant to the tissue. The
first fastener may be positioned within the implant or on the
surface of the implant. The suture may be placed against or within
the implant.
[0053] In accordance with another aspect of the present invention,
there is provided a method for anchoring an implant for directional
expansion within the body. A first fastener is positioned in
contact with the first side of an expandable implant. A second
fastener is positioned in contact with tissue located adjacent a
second side of the implant which is opposite the first side. A
first suture is positioned between the fasteners and tensioned. The
first suture is secured with the first and second fasteners. In
this configuration, the first side of the expandable implant is
restricted from expanding, but all other sides of the implant can
expand.
[0054] For further restriction of expansion, a third fastener is
positioned in contact with the second side of the implant. A fourth
fastener is positioned in contact with tissue located adjacent the
first side of the implant. A second suture is positioned between
the third and fourth fasteners. The second suture is tensioned and
secured with the fasteners. The second side of the implant is
restricted from expanding. To further restrict expansion of the
implant, more fasteners and sutures may be positioned as previously
described such that the implant is limited to expansion in one,
two, or more directions.
[0055] The sutures may be positioned in contact with the expandable
implant such that the sutures transmit force to the implant thereby
anchoring the implant and further restricting expansion.
[0056] In accordance with a further aspect of the present
invention, a device for anchoring an implant is provided. The
device includes a pouch dimensioned and configured for receiving an
implant. The pouch has an access port for inserting the implant. At
least one anchoring point is connected with the pouch. The device
may further include a flap attached to the pouch for closing the
access port. The implant may be expandable, and when positioned in
the pouch, the implant generally expands primarily in the direction
of the access port. The pouch may include a plurality of access
ports. An expandable implant placed in a pouch with a plurality of
access ports expands primarily in the directions of the access
ports.
[0057] In accordance with another aspect of the present invention,
there is provided a method for repairing a ligament. A fastener is
positioned in contact with the ligament adjacent the first side of
a damaged region of the ligament. Another fastener is positioned in
contact with the ligament adjacent a second side of the damaged
region which is generally opposite the first side. A suture is
positioned between the fasteners. The suture is tensioned and
secured with the fasteners such that the ligament is tightened. The
suture may be positioned through the ligament. The suture may also
be positioned through tissue adjacent the damaged area. The tissue
may be spine tissue such as one or more vertebrae and one or more
intervertebral discs. The ligament may be a ligament of the spine
such as the anterior or posterior longitudinal ligament, or any of
the previously identified ligaments. The damaged region may be a
loosened ligament area, a torn ligament area, or a missing ligament
area.
[0058] Furthermore, a method for reconstructing a ligament is
provided. A tissue graft is positioned adjacent a damaged region of
the ligament. A first fastener is positioned in contact with the
tissue graft on a first side of the damaged region. A second
fastener is positioned in contact with the tissue graft on a second
side of the damaged region which is generally opposite the first
side. A suture is positioned between the fasteners with the suture
passing through the tissue graft and ligament. The suture is
tensioned and secured with the fasteners to hold the tissue graft
against the ligament. The tissue graft may include ligamentous
tissue or bone tissue. The ligament may be a ligament of the spine.
The suture may be positioned within tissue located adjacent the
ligament. The tissue may be spine tissue including one or more
vertebrae and one or more intervertebral discs.
[0059] Moreover, there is provided another method for
reconstructing a ligament. A tissue graft is positioned adjacent a
damaged region of the ligament. A first fastener is positioned in
contact with the tissue graft on a first side of the damaged
region. A second fastener is positioned in contact with tissue
adjacent the ligament. A suture is positioned between the fasteners
with the suture passing through the tissue graft and ligament. The
suture is tensioned and secured to the fasteners such that at least
a portion of the tissue graft is held to the ligament. The tissue
graft may include ligamentous tissue or bone tissue. The ligament
may be a ligament of the spine like the anterior or posterior
longitudinal ligament. The suture may be positioned within the
tissue adjacent the ligament. The tissue may be spine tissue
including one or more vertebrae and one or more intervertebral
discs.
[0060] The present disclosure includes a tissue fixation system.
The system comprises an elongate fastening member and a fastener
moveable with respect to the elongate fastening member from a first
orientation to a second orientation, the fastener having a body
with a tissue contacting surface that includes a groove configured
and dimensioned to receive a portion of the elongate member in the
first orientation. The system can also include a second fastener or
other means for maintaining tension in the elongate fastening
member.
[0061] A biasing means can be provided to maintain the fastener in
the first orientation. The biasing means can be an adhesive between
the groove and the portion of the elongate fastening member
received in the groove. The biasing means could also be a frangible
connection between the groove and the portion of the elongate
fastening member received in the groove.
[0062] The fastener body can have a free surface opposite the
tissue contacting surface, with the free surface including a
channel configured and dimensioned to receive a portion of the
elongate member in the first orientation. The fastener body can
also include a through bore extending from the tissue contacting
surface through the free surface.
[0063] In one embodiment, the fastener body includes leading and
trailing ends. The leading end can be tapered or otherwise shaped
to facilitate insertion. The groove terminates at the through bore
and extends toward one of the leading and trailing ends and the
channel terminates at the through bore and extends toward the other
of the leading and trailing ends. In an exemplary embodiment, the
groove extends toward the leading end and the channel extends
toward the trailing end.
[0064] The free surface of the fastener body can be provided with a
well surrounding the through bore. The well can be configured and
dimensioned to receive at least a portion of the stop. A distal end
of the elongate fastening member can include a stop larger than the
through bore.
[0065] The present invention also relates to a medical instrument
or device for securing the fastener with respect to the elongate
fastening member. The medical device tensions the elongate
fastening member and crimps either the fastener or a bushing.
Another aspect of the invention relates to methods of tissue
fixation using the disclosed tissue fixation systems.
[0066] In an aspect, a method for stabilizing a spinal anatomical
structure may include introducing, into a body, a curved segment of
an elongate, fastener placement rod approximate to, adjacent to or
on a spinal anatomical structure, the curved segment having a
leading end; providing, at the leading end of the curved segment of
the fastener placement rod, a fastener approximate to, adjacent to
or on the spinal anatomical structure; and securing the fastener
with respect to the spinal anatomical structure.
[0067] In a detailed embodiment, the fastener may be secured with
respect to the spinal anatomical structure utilizing at least one
flexible line. In a detailed embodiment, the at least one flexible
line may extend from the fastener, through at least a portion of
the spinal anatomical structure to a separate securing point within
the body. In a detailed embodiment, a method may include securing
the at least one flexible line at the separate securing point by a
second fastener. In a detailed embodiment, the step of securing the
at least one flexible line at the separate securing point by the
second fastener may include crimping the second fastener to the
flexible line. In a detailed embodiment, the crimping step may
include introducing a crimping mechanism extending from an elongate
rod of a crimping tool through an incision in the body and adjacent
to the second fastener. In a detailed embodiment, the at least one
flexible line may include a suture. In a detailed embodiment, the
at least one flexible line may include a cable.
[0068] In a detailed embodiment, the flexible line may be provided
attached to the fastener approximate to, adjacent to or on the
spinal anatomical structure, and the method may include a step of
passing the flexible line from the fastener and at least through
the portion of the spinal anatomical structure to the separate
securing point within the body. In a detailed embodiment, the
passing step may be performed utilizing a gripper at a leading end
of an elongate gripper rod which pulls the flexible line from the
fastener and at least through the portion of the spinal anatomical
structure to the separate securing point within the body. In a
detailed embodiment, the elongate fastener placement rod and
elongate gripper rod may extend from a hand-held guidance and
positioning device. In a detailed embodiment, a method may include
forming a hole through the portion of the spinal anatomical
structure prior to the pulling step. In a detailed embodiment, the
hole forming step may be performed by an elongate drill rod
extending from the hand-held guidance and positioning device. In a
detailed embodiment, the elongate gripper rod and elongate drill
rod may be guided by a guide tube extending from the hand-held
guidance and positioning device.
[0069] In a detailed embodiment, the elongate gripper rod may
extend from the hand-held guidance and positioning device along an
axis that runs adjacent to or through the leading end of the curved
segment of the fastener placement rod.
[0070] In a detailed embodiment, a method may include forming a
hole through the portion of the spinal anatomical structure prior
to the passing step.
[0071] In a detailed embodiment, the spinal anatomical structure
may be a first spinal anatomical structure; the flexible line may
be provided attached to the fastener approximate to, adjacent to or
on the spinal anatomical structure; and a method may include a step
of passing the flexible line from the fastener and at least through
the portion of the first spinal anatomical structure, through at
least a portion of a second anatomical structure to the separate
securing point within the body, thereby stabilizing at least the
first and second spinal anatomical structures with respect to each
other. In a detailed embodiment, the first spinal anatomical
structure may include an intervertebral disc and the second spinal
anatomical structure may include a vertebra. In a detailed
embodiment, the first spinal anatomical structure may include a
first vertebra and the second spinal anatomical structure may
include a second vertebra. In a detailed embodiment, the first
spinal anatomical structure may include a vertebra and the second
spinal anatomical structure may include an intevertebral disc. In a
detailed embodiment, the first spinal anatomical structure may
include a first spinous process and the second spinal anatomical
structure may include a second spinous process. In a detailed
embodiment, the first spinal anatomical structure may include a
first ligament segment and the second spinal anatomical structure
may include a second ligament segment. In a detailed embodiment,
the first and second ligament segments may be torn or severed
segments of the same ligament. In a detailed embodiment, the first
spinal anatomical structure may include a ligament and the second
spinal anatomical structure may include a vertebra. In a detailed
embodiment, the first spinal anatomical structure may include a
ligament and the second spinal anatomical structure may include an
intevertebral disc. In a detailed embodiment, the first spinal
anatomical structure may include a vertebra and the second spinal
anatomical structure is a ligament. In a detailed embodiment, the
first spinal anatomical structure may include an intervertebral
disc and the second spinal anatomical structure may include a
ligament.
[0072] In a detailed embodiment, a method may include a step of
passing the flexible line from the fastener and at least through
the portion of the first spinal anatomical structure, through at
least a portion of a second anatomical structure, and through at
least a portion of a third anatomical structure to the separate
securing point within the body, thereby stabilizing at least the
first, second and third spinal anatomical structures with respect
to each other. In a detailed embodiment, at least two of the first,
second and third spinal anatomical structures may include spinous
processes. In a detailed embodiment, at least two of the first,
second and third spinal anatomical structures may include
facets.
[0073] In a detailed embodiment, the drawing step may include
passing the flexible line through an implant. In a detailed
embodiment, the implant may include a graft. In a detailed
embodiment, the implant may include a disc implant. In a detailed
embodiment, the implant may include a scaffold.
[0074] In a detailed embodiment, the first spinal anatomical
structure may include a spinous process and the second spinal
anatomical structure may include at least one of a pedicle and bone
of a facet joint. In a detailed embodiment, the first spinal
anatomical structure may include at least one of a pedicle and bone
of a facet joint and the second spinal anatomical structure may
include a spinous process. In a detailed embodiment, the first
spinal anatomical structure may include a first side of a cervical
spine and the second anatomical structure may include a second side
of the cervical spine. In a detailed embodiment, a method may
include passing the flexible line through a tubular implant
positioned between the first and second spinal anatomical
structures. In a detailed embodiment, the first spinal anatomical
structure may include a first facet and the second spinal
anatomical structure may include a second facet.
[0075] In a detailed embodiment, a method may include a step of
tensioning at least a portion of the flexible line extending
between the fastener and the separate securing point. In a detailed
embodiment, the spinal anatomical structure may include annulus
fibrosus. In a detailed embodiment, the spinal anatomical structure
may include nucleus pulposus. In a detailed embodiment, the
flexible line may extend through an intervertebral disc and through
an adjacent vertebra. In a detailed embodiment, the flexible line
may extend through adjacent vertebrae and an intervertebral disc
between the adjacent vertebrae. In a detailed embodiment, the
flexible line may extend through two vertebrae and a disc
positioned between but not adjacent to each of the two vertebrae.
In a detailed embodiment, the flexible line may extend through an
upper spinous process and through a lower spinous process. In a
detailed embodiment, the flexible line may extend through a
vertebra and to or though a disc implant. In a detailed embodiment,
the flexible line may extend through the spinal anatomical
structure to or through a graft.
[0076] In a detailed embodiment, the flexible line may extend
through the spinal anatomical structure and through or to a disc
implant or a vertebral implant. In a detailed embodiment, the
spinal anatomical structure may include annulus fibrosus. In a
detailed embodiment, the spinal anatomical structure may include a
vertebra. In a detailed embodiment, the spinal anatomical structure
may include a facet.
[0077] In a detailed embodiment, the flexible line may extend
through two severed portions of a spinal ligament. In a detailed
embodiment, the flexible line may extend through two portions of a
spinal ligament. In a detailed embodiment, the flexible line
further may extend through a vertebra adjacent to at least one of
the two portions of the spinal ligament. In a detailed embodiment,
the flexible line may further extend through an intervertebral
disc.
[0078] In a detailed embodiment, the flexible line may extend to or
through a stabilization rod or plate. In a detailed embodiment, the
spinal anatomical structure may include a spinous process.
[0079] In a detailed embodiment, the flexible line may extend
through at least one portion of a spinal ligament and through or to
a ligament graft.
[0080] In a detailed embodiment, at least a portion of the elongate
fastener placement rod may be hollow. In a detailed embodiment, the
portion of the elongate fastener placement rod that may be hollow
may open onto the leading end of the curved segment of the fastener
placement rod. In a detailed embodiment, the step of providing, at
the leading end of the curved segment of the fastener placement
rod, a fastener approximate to, adjacent to or on the spinal
anatomical structure, may include a step of sending the fastener
through the portion of the elongate faster placement rod that is
hollow to the leading end of the curved segment. In a detailed
embodiment, the sending step may further include sending a flexible
line with the fastener through the portion of the elongate fastener
placement rod that may be hollow to the leading end of the curved
segment, wherein the fastener may be secured in place utilizing at
least a portion of flexible line.
[0081] In a detailed embodiment, the step of providing, at the
leading end of the curved segment of the fastener placement rod, a
fastener approximate to, adjacent to or on the spinal anatomical
structure, may be preceded by a step of engaging the fastener with
the leading end of the curved segment of the fastener placement
rod.
[0082] In a detailed embodiment, a method may include a step of
engaging the fastener with the leading end of the curved segment of
the fastener placement rod. In a detailed embodiment, the engaging
step may include a step of disposing at least a portion of the
fastener within the leading end of the curved segment of the
fastener placement rod. In a detailed embodiment, a method may
include a step of disengaging the fastener from the leading end of
the curved segment of the fastener placement rod while the fastener
is approximate to, adjacent to or on the spinal anatomical
structure.
[0083] In a detailed embodiment, the introducing step may include
introducing the curved segment of an elongate, fastener placement
rod through an incision in the skin as part of a minimally invasive
procedure.
[0084] In a detailed embodiment, the spinal anatomical structure
may include at least one of bone, vertebral body, nucleus pulposus,
muscle, tendon and cartilage.
[0085] In a detailed embodiment, the spinal anatomical structure
may include at least one bone such as a transverse process,
pedicle, facet, spinous process, posterior arch, odontoid process,
posterior tubercle, lateral articular process, uncinate process,
anterior tubercle, carotid tubercle, odontoid process, lamina and
vertebral body.
[0086] In a detailed embodiment, the spinal anatomical structure
may include at least one ligament taken such as an anterior
longitudinal ligament, posterior longitudinal ligament,
interspinous ligament, supraspinous ligament, ligamentum flavum,
intertransverse ligament, facet capsulary ligament, ligamentum
nuchae, ligament of the sacrum and ligament of the coccyx
spine.
[0087] In an aspect, a method for stabilizing a spinal anatomical
structure may include connecting a flexible line and a fastener;
introducing, through an incision in the body, a curved segment of
an elongate, fastener placement rod approximate to, adjacent to or
on a spinal anatomical structure, the curved segment having a
leading end; providing, at the leading end of the curved segment of
the fastener placement rod, the fastener and attached flexible line
at a fastener placement point that is approximate to, adjacent to
or on the spinal anatomical structure, the providing step including
passing the fastener and attached flexible line through the curved
segment of the elongate fastener placement rod to the leading end;
passing the connected flexible line from approximate the fastener
placement point through at least a portion of the spinal anatomical
structure to a securing point; tensioning the flexible line between
the fastener placement point and the securing point; and securing
the flexible line at the securing point.
[0088] In a detailed embodiment, the step of securing the flexible
line at the securing point may include a step of tying the flexible
line. In a detailed embodiment, the step of securing the flexible
line at the securing point may include a step of fastening the
flexible line at the securing point using another fastener. In a
detailed embodiment, the step of fastening the flexible line at the
securing point using another fastener may include crimping the
other fastener to the flexible line. In a detailed embodiment, the
flexible line may include a suture. In a detailed embodiment, the
flexible line may include a cable.
[0089] In a detailed embodiment, the passing step may be performed
utilizing a gripper at a leading end of an elongate gripper rod to
pull the connected flexible line from approximate the fastener
placement point through at least the portion of the spinal
anatomical structure to the securing point. In a detailed
embodiment, the elongate fastener placement rod and the elongate
gripper rod may extend from a hand-held guidance and positioning
device. In a detailed embodiment, a method may include forming a
hole through the portion of the spinal anatomical structure prior
to the pulling step. In a detailed embodiment, the hole forming
step may be performed by an elongate drill rod extending from the
hand-held guidance and positioning device. In a detailed
embodiment, the elongate gripper rod and the elongate drill rod may
be guided by a guide tube extending from the hand-held guidance and
positioning device.
[0090] In a detailed embodiment, the spinal anatomical structure
may include annulus fibrosus. In a detailed embodiment, the
flexible line may extend through an intervertebral disc and through
an adjacent vertebra. In a detailed embodiment, the flexible line
may extend through adjacent vertebrae and an intervertebral disc
between the adjacent vertebra. In a detailed embodiment, the
flexible line may extend through two vertebrae and a disc
positioned between but not adjacent to each of the two vertebrae.
In a detailed embodiment, the flexible line may extend through an
upper spinous process and through a lower spinous process. In a
detailed embodiment, the flexible line may extend through a
vertebra and to or though a disc implant. In a detailed embodiment,
the flexible line may extend through the spinal anatomical
structure to or through a graft.
[0091] In a detailed embodiment, the flexible line may extend
through the spinal anatomical structure and through or to a disc
implant or a vertebral implant. In a detailed embodiment, the
spinal anatomical structure may include annulus fibrosus. In a
detailed embodiment, the spinal anatomical structure may include a
vertebra. In a detailed embodiment, the spinal anatomical structure
may include a facet.
[0092] In a detailed embodiment, the flexible line may extend
through two severed portions of a spinal ligament.
[0093] In a detailed embodiment, the flexible line may extend
through two portions of a spinal ligament. In a detailed
embodiment, the flexible line may further extend through a vertebra
adjacent to at least one of the two portions of the spinal
ligament. In a detailed embodiment, the flexible line may further
extend through an intervertebral disc.
[0094] In a detailed embodiment, the flexible line may extend to or
through a stabilization rod or plate. In a detailed embodiment, the
spinal anatomical structure may include a spinous process.
[0095] In a detailed embodiment, the flexible line may extend
through at least one portion of a spinal ligament and through or to
a ligament graft.
[0096] In a detailed embodiment, the spinal anatomical structure
may include a first spinal anatomical structure; and a method may
include a step of passing the flexible line from approximate the
fastener and at least through the portion of the first spinal
anatomical structure, through at least a portion of a second
anatomical structure to the securing point, thereby stabilizing at
least the first and second spinal anatomical structures with
respect to each other. In a detailed embodiment, the first spinal
anatomical structure may include an intervertebral disc and the
second spinal anatomical structure may include a vertebra. In a
detailed embodiment, the first spinal anatomical structure may
include a first vertebra and the second spinal anatomical structure
may include a second vertebra. In a detailed embodiment, the first
spinal anatomical structure may include a vertebra and the second
spinal anatomical structure may include an intevertebral disc. In a
detailed embodiment, the first spinal anatomical structure may
include a first spinous process and the second spinal anatomical
structure may include a second spinous process.
[0097] In a detailed embodiment, the first spinal anatomical
structure may include a first ligament segment and the second
spinal anatomical structure may include a second ligament segment.
In a detailed embodiment, the first and second ligament segments
may include torn or severed segments of the same ligament.
[0098] In a detailed embodiment, the first spinal anatomical
structure may include a ligament and the second spinal anatomical
structure may include a vertebra. In a detailed embodiment, the
first spinal anatomical structure may include a ligament and the
second spinal anatomical structure may include an intevertebral
disc. In a detailed embodiment, the first spinal anatomical
structure may include a vertebra and the second spinal anatomical
structure may include a ligament. In a detailed embodiment, the
first spinal anatomical structure may include an intervertebral
disc and the second spinal anatomical structure may include a
ligament.
[0099] In a detailed embodiment, the method may include a step of
passing the flexible line from the fastener and at least through
the portion of the first spinal anatomical structure, through at
least a portion of a second anatomical structure, and through at
least a portion of a third anatomical structure to the separate
securing point within the body, thereby stabilizing at least the
first, second and third spinal anatomical structures with respect
to each other. In a detailed embodiment, at least two of the first,
second and third spinal anatomical structures may include spinous
processes. In a detailed embodiment, at least two of the first,
second and third spinal anatomical structures may include
facets.
[0100] In a detailed embodiment, the passing step may further
include passing the flexible line through an implant. In a detailed
embodiment, the implant may include a graft. In a detailed
embodiment, the implant may include a disc implant. In a detailed
embodiment, the implant may include a scaffold.
[0101] In a detailed embodiment, the first spinal anatomical
structure may include a spinous process and the second spinal
anatomical structure may include at least one of a pedicle and bone
of a facet joint. In a detailed embodiment, the first spinal
anatomical structure may include at least one of a pedicle and bone
of a facet joint and the second spinal anatomical structure may
include a spinous process. In a detailed embodiment, the first
spinal anatomical structure may include a first side of a cervical
spine and the second anatomical structure may include a second side
of the cervical spine. In a detailed embodiment, the method may
further include passing the flexible line through a tubular implant
positioned between the first and second spinal anatomical
structures. In a detailed embodiment, the first spinal anatomical
structure may include a first facet and the second spinal
anatomical structure may include a second facet.
[0102] In an aspect, a method for stabilizing a spinal anatomical
structure may include a step for introducing a fastener approximate
to, adjacent to or on a spinal anatomical structure using a curved
end of an introducer means; a step for passing a flexible line
attached to the fastener through at least a portion of the spinal
anatomical structure to a securing point; and a step for securing
the flexible line at the securing point.
[0103] In a detailed embodiment, a method may include a step for
tensioning the flexible line between the fastener and the securing
point.
BRIEF DESCRIPTION OF THE DRAWINGS
[0104] The detailed description refers to the following figures in
which:
[0105] FIG. 1 shows an exemplary embodiment of the guidance and
positioning device of the present invention;
[0106] FIG. 2 illustrates a cannulated drill system inserted in the
device;
[0107] FIG. 3 shows a pushrod configured for inserting a fastener
and suture into a hook of the positioning device;
[0108] FIG. 4 illustrates a fastener and suture positioned in the
hook;
[0109] FIG. 5 shows a suture claw positioned in the guide channel
of the device;
[0110] FIG. 6 illustrates the suture claw withdrawn from the guide
channel with the suture disposed in the guide channel;
[0111] FIG. 7 shows the suture connected with the fastener on the
distal side of the bone and the suture extending from the drill
system;
[0112] FIG. 8 illustrates a fractured bone with the suture
extending therethrough;
[0113] FIG. 9 shows a fastener positioned on the proximal side of
the bone and secured to the suture;
[0114] FIG. 10 illustrates another embodiment of the implant
guidance and positioning device;
[0115] FIG. 11 shows a cannulated drill system disposed in a guide
slot of the device;
[0116] FIG. 12 illustrates a fastener disposed in a socket on the
distal end of a hookshaped member of the device;
[0117] FIG. 13 shows a fastening member positioned in the guide
slot of the device;
[0118] FIG. 14 illustrates a threaded distal portion of the
fastening member disposed in a threaded hole of the fastener;
[0119] FIG. 15 shows a fractured bone with the fastening member
extending therethrough;
[0120] FIG. 16 illustrates a fastener positioned on the proximal
side of the bone and secured to the fastening member;
[0121] FIG. 17 shows one embodiment of a clamping mechanism of the
device;
[0122] FIG. 18 illustrates another embodiment of the clamping
mechanism of the device;
[0123] FIG. 19 shows an embodiment of a tensioning mechanism of the
device;
[0124] FIGS. 20A-20H illustrate multiple embodiments of fasteners
and fastener assemblies;
[0125] FIGS. 21A-21G show a plurality of embodiments of tissue
alignment sleeves;
[0126] FIG. 22 illustrates the repair of the annulus of an
intervertebral disc as well as stabilization of the spinal
joint;
[0127] FIG. 23 illustrates a total intervertebral disc replacement
implant;
[0128] FIG. 24 illustrates an embodiment for the anchoring of an
implant;
[0129] FIG. 25 shows a further embodiment for the anchoring of an
implant;
[0130] FIG. 26 illustrates anchorage of an expandable implant for
directional expansion;
[0131] FIGS. 27A-27C show multiple embodiments of implant
pouches;
[0132] FIG. 28 illustrates ligament repair and stabilization;
[0133] FIG. 29 shows ligament reconstruction and stabilization;
[0134] FIGS. 30A-30C illustrate ligament
augmentation/reinforcement;
[0135] FIG. 31 shows a laminectomy site;
[0136] FIG. 32 illustrates stabilization of the cervical spine and
head; and
[0137] FIG. 33 shows decompression and stabilization of the spinal
column.
[0138] FIG. 34 illustrates a drill/sleeve combination in accordance
with the present invention;
[0139] FIG. 35 is a cross sectional view of FIG. 34;
[0140] FIG. 36 shows the drill/sleeve combination in use to repair
a fractured bone;
[0141] FIG. 37 illustrates the sleeve positioned across the
fracture of the bone;
[0142] FIG. 38 shows another exemplary embodiment of the
drill/sleeve combination;
[0143] FIG. 39 is a cross sectional view of FIG. 38;
[0144] FIG. 40 illustrates the drill/sleeve combination functioning
as a fastener;
[0145] FIG. 41 shows an exemplary distal portion of the
fastener;
[0146] FIG. 42 illustrates another exemplary distal portion of the
fastener; and
[0147] FIG. 43 shows another embodiment of the guidance and
positioning device having multiple hooks and guide channels.
[0148] FIG. 44 shows a schematic illustration of a tissue fixation
system according to the present invention utilized for fracture
fixation;
[0149] FIG. 45 shows a perspective view of a fastener according to
the present invention;
[0150] FIG. 46 shows a side view of the fastener of FIG. 45;
[0151] FIG. 47 shows a bottom view of the fastener of FIG. 45;
[0152] FIG. 48 shows a top view of the fastener of FIG. 45;
[0153] FIG. 49 shows a fastener and elongate fastening member with
the fastener in a first orientation with respect to the elongate
fastening member;
[0154] FIG. 50 shows a front view of a fastener in the first
orientation with respect to the elongate fastening member with the
fastener rotated 180.degree. compared to FIG. 49;
[0155] FIG. 51 shows a back view of the fastener and elongate
fastening member of FIG. 50;
[0156] FIG. 52A shows an elongate fastening member according to the
present invention;
[0157] FIG. 52B shows an elongate fastening member including
expandable members;
[0158] FIG. 53 shows a fastener in a second orientation with
respect to an elongate fastening member;
[0159] FIG. 54 shows a cannulated drill system used to create a
passage through the tissue to be fixed;
[0160] FIG. 55 shows a sleeve having a lumen through which the
fixation system can be passed;
[0161] FIG. 56 shows a distal fastener being inserted into the
sleeve;
[0162] FIG. 57 shows a pushrod used to move the distal fastener
through the sleeve;
[0163] FIG. 58 shows the distal fastener in the second
orientation;
[0164] FIG. 59 shows a proximal fastener being used to maintain the
tension in the elongate fastening member;
[0165] FIG. 60 depicts a front isometric view of the medical device
of the present invention;
[0166] FIG. 61 depicts a rear partial isometric view showing the
tensioning mechanism of the medical device of FIG. 60;
[0167] FIG. 62 depicts a rear isometric view showing the tensioning
mechanism of the medical device of FIG. 60;
[0168] FIG. 63 depicts an isometric view of the crimping mechanism
collett of the medical device of FIG. 60;
[0169] FIG. 64 depicts a partial isometric view showing the handle
portion of the crimping mechanism of the medical device of FIG.
60;
[0170] FIG. 65 depicts a top sectional view of the crimping
mechanism collett closer of the medical device of FIG. 60;
[0171] FIG. 66 depicts a partial isometric view showing the cutting
mechanism of the medical device of FIG. 60;
[0172] FIG. 67 depicts a partial isometric view showing the collett
portion of the cutting mechanism of FIG. 66;
[0173] FIG. 68 depicts an isometric view showing the cutting arm of
the cutting mechanism of FIG. 67;
[0174] FIG. 69 depicts the medical device of FIG. 60 in use to
secure a bone fracture;
[0175] FIG. 70 depicts a front isometric view of an alternative
medical device of the present invention;
[0176] FIG. 71 depicts an isometric view of the crimping mechanism
collett of the medical device of FIG. 70;
[0177] FIG. 72 depicts an isometric view of the crimping mechanism
collett closer of the medical device of FIG. 70;
[0178] FIG. 73 depicts a sectional view of the medical device of
FIG. 70 in use to secure a bone fracture;
[0179] FIG. 74 depicts an exemplary fastener for use with the
medical device of FIG. 70;
[0180] FIG. 75 depicts an alternative sectional view of the medical
device of FIG. 70 in use to secure a bone fracture;
[0181] FIG. 76 depicts an alternative fastener for use with the
medical device of FIG. 75;
[0182] FIG. 77 depicts an alternative cable tensioner for the
medical device of FIG. 60;
[0183] FIG. 78 depicts a sectional view of the cable tensioner of
FIG. 77;
[0184] FIG. 79 depicts a front isometric view of the medical device
of the present invention;
[0185] FIG. 80 depicts a side sectional view showing the tensioning
mechanism of the medical device of FIG. 79;
[0186] FIG. 81 depicts a rear exploded view showing the tensioning
mechanism of the medical device of FIG. 79;
[0187] FIG. 82 depicts an isometric view of the crimping mechanism
collett of the medical device of FIG. 79;
[0188] FIG. 83 depicts a partial isometric view showing the handle
portion of the crimping mechanism of the medical device of FIG.
79;
[0189] FIG. 84 depicts a partial isometric view showing the cutting
mechanism of the medical device of FIG. 79;
[0190] FIG. 85 depicts an isometric view of the cutting mechanism
in the collett of the medical device of FIG. 79;
[0191] FIG. 86 depicts the cutting wedge of the medical device of
FIG. 79; and
[0192] FIG. 87 depicts a safety lock of the medical device of FIG.
79.
DETAILED DESCRIPTION
[0193] The present disclosure includes instruments and methods for
guiding and positioning tissue and/or an implant within the body.
The instrument may provide for the placement of a biocompatible
implant within tissue or may provide for dynamic and rigid fixation
of tissue. The device can access and treat a fractured, incised or
torn tissue, or the like, from one access area (i.e., from only one
opening to the tissue to be fastened) instead of requiring two or
more openings. That is, the device is a linear system that can be
used with a single, small incision or portal in the skin or other
soft tissue to gain access to the tissue, for example a fractured
bone.
[0194] The guidance and positioning device may be an all-in-one
system for creating a passage in tissue, positioning fasteners or
other implants, and tensioning an elongated fastening member, like
a suture, thread, wire, or pin (generally, a "flexible line"). In
some embodiments, the device may allow for the implantation of
multiple sutures and fasteners in tissue with little or no
repositioning of the device. For example, the device may have two
or more of the elements described below connected to a single grip
or handle. Likewise, the incision or opening providing access to
the treated bone or tissue may extend at least partially in a
direction along the length of the treated area so that the
processes described below may be repeatedly performed on other,
nearby portions of the bone or tissue in a similar manner.
[0195] Tissue Repair
[0196] Referring now to the drawing figures in which like reference
designators refer to like elements, there is shown in FIG. 1 an
exemplary embodiment of the guidance and positioning device 20. The
device includes a generally cylindrical handle 22 and a hook 24
with a proximal end connected to the handle 22. In one embodiment,
the hook has a tubular construction (e.g., may be hollow). An
interior passageway may extend from the proximal end to the distal
end. The hook 24 (which may be referred to as a fastener placement
rod) may be curved as illustrated in the Figures, may be angular
(e.g., may have an open-sided geometric shape), or may have any
other desired shape so that its distal end is disposed
approximately around the bone or tissue to be treated or
fastened.
[0197] The proximal portion of the hook 24 may be positioned
generally parallel with the longitudinal axis of the handle 22. A
plurality of interchangeable hooks 24 may be releasably and
interchangeably connected to the handle. In this manner, hooks of
different sizes, shapes, or other features may be selected and used
as desired by a physician. Thus, the device 20 may have a lever,
clip, set-screw, button, spring, match, or latch 26 that allows
selective securing and releasing of hooks 24 to or from the handle
22. The lever 26 allows different sized hooks 24 to be placed in
the handle 22. For example, the hook may include different sized
lumens extending therethrough, may be different lengths, and/or may
have different radii of curvature. The curved or angled portion 28
of the hook 24 may be configured for positioning around a fractured
bone 30 (as seen in FIG. 1), multiple pieces of similar tissue,
multiple pieces of different tissue, or a single tissue element.
Examples of such tissue includes, not is not limited to, bone,
muscle, cartilage, ligament, tendon, skin, etc. Also, the tissue
may be stomach tissue, and the positioning device may be used
during bariatric surgery, like gastric stapling. It is further
contemplated that measurements such as the depth, angle, length,
and/or compression of the hook may be determined. The handle may
include guides or indicia for measuring and displaying these
measurements. Alternatively, the positioning device may include
sensors for taking these measurements. For example, the handle of
the device may include sensors and/or radiofrequency transmitters
for determining and sending measurements to a computer and/or
display.
[0198] A guide channel 32 (which may be referred to as a guide
tube) extends through the handle 22. Preferably, the guide channel
32 extends generally parallel with the longitudinal axis of the
handle 22. The longitudinal axis of the guide channel 32 is
generally aligned with or is slightly offset from the distal end 34
of the hook 24. For instance, the shortest distance between the
longitudinal axis of the guide channel and the distal end of the
hook may be about 2 cm or less. In other embodiments, the shortest
distance may be about 1 cm or less, or even about 0.25 cm or
less.
[0199] Preferably, the guide channel 32 and hook 24 are configured
so that the device can be used with a single, small incision in the
skin or other soft tissue to gain access to the fractured bone or
other tissue requiring fixation. For example, the portions of the
guide channel 32 and hook 34 that are near the opening or incision
may be spaced apart from each other by about 5 cm or less, and
preferably are spaced about 2 cm or less from each other near the
incision or opening. In one embodiment, the guide channel and hook
are generally parallel and relatively close to each other for a
substantial portion of the distance between the handle and the
incision or opening.
[0200] In use, the device 20 is positioned with the curved portion
28 (also referred to as a curved segment) of the hook 24 placed
next to and around the tissue to be fastened. The hook may be
positioned subcutaneously, percutaneously, and/or minimally
invasively. The tissue may be a fractured bone, a tissue fragment
having tendon and bone or ligament and bone, or a tissue with
avulsion type fragments. In FIG. 2, a curved portion 28 of the hook
24 is placed around a fractured bone 30 (fracture not shown) or
tissue. A drill system 36 is positioned in the guide channel 32.
The drill system 36 includes a headpiece 38 configured for
attachment to a drill 40. A drill bit 42 (also referred to as a
drill rod) is positioned at the distal end of the drill system 36.
A drill stop 44 is located distal from the headpiece 38 and
prevents the drill bit 42 from penetrating too far beyond the
tissue to be drilled. The drill system 36 may be a cannulated drill
system. A cannula or sleeve 46 may encircle the drill bit 42 or at
least the shaft portion of the drill bit 42. As the drill bit 42
creates a passage 48 through the bone 30, the sleeve 46 is
positioned in the passage 48 to link the bone passage 48 and the
guide channel 32. The drill system 36 is used to create a passage
48 in the bone 30 from the proximal side of the bone 30 to the
distal side of the bone 30, then the drill 40 and drill bit 42 are
removed from the sleeve 46 and guide channel 32. The distal opening
of the bone passage 48 is generally near the distal aperture 50
(which may be located at or near the leading end) of the hook
24.
[0201] It is contemplated that the drill system may be used to
create a non-linear passage in tissue. The non-linear passage may
be formed to go around implants such as an intramedullary rod or
prosthesis. The non-linear passage may also allow a physician to
avoid critical body parts or tissues such as vessels or organs.
Alternatively, a no drill system may be employed to create a
passage in the tissue. Rather, as described in more detail below,
the guide channel may be used to guide and position a
self-introducing elongate member like a guide wire, k-wire, claw,
grabber, etc. The self-introducing member may be forced through the
soft or hard tissue instead of pre-drilling a passage.
[0202] Next, as seen in FIG. 3, a fastener 52 is positioned at the
distal end of a flexible pushrod 54. The fastener 52 may be
connected with the pushrod 54 or may be loosely fitted with the
distal end of the pushrod 54. A suture 56 is looped through or
connected with the fastener 52 such that one, two, or more
sections, legs, strands, or portions of the suture 56 extend from
the fastener 52. Examples of fasteners may be found in U.S. Pat.
Nos. 5,163,960 and 5,593,425 entitled "Surgical Devices Assembled
Using Heat Bondable Materials" which disclose fasteners assembled
from a plurality of discrete components, one of which includes a
heat bondable material for bonding the components together. The
heat bondable material is preferably a polymeric or composite
material suitable for surgical applications and implantation in the
human body. The heat bondable material may be a biodegradable
material. A laser, hot air gun, welding gun, soldering gun, or
Bovie tip may be used as a heat source for bonding the fastener.
U.S. Pat. No. 6,368,343 entitled "Method of Using Ultrasonic
Vibration to Secure Body Tissue" further discloses using ultrasonic
vibration energy to bond the heat bondable material of the
components of the fastener.
[0203] U.S. Pat. No. 5,403,348 entitled "Suture Anchor" discloses
an anchor for securing a suture in the body. The anchor includes a
tubular wall having a central axis. The tubular wall has a proximal
end and a distal end each free of axially inwardly extending slots.
The tubular wall also has an inner surface extending for the entire
length of the tube and defining in the anchor a central opening
extending between the proximal end and the distal end. The anchor
has a width less than its length. A suture may extend through the
anchor within the central opening. First and second end portions of
the suture extend out of opposite ends of the anchor and are
sufficiently long to project out of the body when the suture is
secured in the body by the anchor. The anchor has an anchoring
orientation in the body achieved by manipulation of the distal end
of the anchor by pulling on the second end portion of the suture.
Furthermore, the anchor has a removal orientation in the body
achieved by manipulation of the proximal end of the anchor by
pulling on the first end portion of the suture.
[0204] U.S. Pat. No. 5,464,426 entitled "Method of Closing
Discontinuity in Tissue" discloses a suture anchor having a
generally cylindrical configuration with a lumen extending
therethrough. In use, a suture is inserted through openings in a
plurality of anchors. Pulling on the suture presses the anchors
against the body tissue and presses the body tissue together. The
anchors may be pushed through the body tissue with a pusher member
or by pushing the anchors against each other.
[0205] U.S. Pat. No. 5,549,630 entitled "Method and Apparatus for
Anchoring a Suture" discloses a tubular anchor having a polygonal
cross-sectional configuration with flat outer side surfaces areas
connected by a plurality of outer corner portions. A passage
through the anchor may be formed by flat inner side surfaces
interconnected by inner corner portions. A suture is inserted
through the passage. A concentrated force may be applied against a
limited area on a trailing end of the anchor to rotate the anchor
to move an outer corner portion of the anchor into engagement with
body tissue. The suture may engage an inner corner portion of the
anchor. The suture may be inserted through a plurality of anchors
and the anchors moved through a tubular member into the body tissue
under the influence of force transmitted from a trailing anchor to
a leading anchor. When the leading anchor is moved into the body
tissue, it is rotated under the influence of force applied against
a trailing end of the leading anchor. If desired, two anchors may
be interconnected. A groove may advantageously be provided along
the leading end and side of an anchor to receive the suture.
[0206] U.S. Pat. No. 5,713,921 entitled "Suture Anchor" discloses a
suture anchor formed from body tissue. The body tissue is shaped to
a desired configuration for the anchor and defines a passage
through the anchor. A suture is inserted into the passage in the
body tissue of the anchor. The anchor is then positioned in a
patient's body with a suture extending into the passage in the
anchor. The anchor may be formed of osseous body tissue, hard
compact bone, dense connective body tissue, or other body tissue.
The body tissue may be dried so that it absorbs fluid and expands
upon being inserted into a patient's body.
[0207] U.S. Pat. No. 5,718,717 also entitled "Suture Anchor"
discloses an anchor formed of a material which absorbs body liquid
when exposed to body liquid. The anchor may be at least partially
formed of a material having a strong affinity for body liquids.
This enables the anchor to absorb body liquid and expand upon being
inserted into a patient's body. At least one embodiment of the
suture anchor has portions formed of a relatively hard material
which does not absorb body liquids and is pressed against body
tissue by the material which absorbs body liquid to mechanically
interlock the suture anchor and the body tissue. The anchor may be
at least partially formed of a cellular material. The cells expand
to absorb body liquid. At least one embodiment of the anchor has a
pointed leading end portion to form an opening in an imperforate
surface on body tissue. The configuration of the anchor may be
changed by tensioning the suture while the anchor is disposed in
body tissue.
[0208] U.S. Pat. No. 5,782,862 entitled "Suture Anchor Inserter
Assembly and Method" discloses a suture anchor inserter assembly
including a manually engageable handle and a shaft which extends
axially outward from the handle. The shaft includes an inner member
which is fixedly connected with the handle and an outer member
which is retractable into the handle. An anchor is received in a
chamber formed at the outer end of the shaft.
[0209] U.S. Pat. No. 5,814,072 entitled "Method and Apparatus for
Use in Anchoring a Suture" discloses a suture anchor inserter
including a manually engageable handle and a shaft which extends
from the handle through a passage in the anchor. During insertion
of the anchor into body tissue, an end portion of the shaft pierces
the body tissue in advance of the anchor. At the same time, a
pusher surface on the shaft applies force against a trailing end
portion of the anchor to push the anchor into the body tissue. When
the orientation of the anchor is to be changed, rotational force is
applied to the anchor by tensioning the suture and pressing the end
portion of the shaft against an inner surface of the passage in the
anchor.
[0210] U.S. Pat. No. 5,814,073 entitled "Method and Apparatus for
Positioning a Suture Anchor" discloses an inserter assembly
operable between a closed condition blocking movement of a suture
anchor through the inserter assembly and an open condition in which
the inserter assembly is ineffective to block movement of the
anchor.
[0211] U.S. Pat. No. 5,845,645 entitled "Method of Anchoring a
Suture" discloses a process of fastening a suture to an anchor. The
suture is inserted through passages which are spaced apart along
and extend transversely to a longitudinal central axis of an
anchor. When the anchor is moved into body tissue, a first portion
of the suture extends from the first passage in the anchor through
an opening in the body tissue to a location disposed to one side of
the body tissue. A second portion of the suture extends from the
second passage in the anchor through the opening in the body
tissue. The suture is tensioned to apply force to the anchor. The
force applied to the anchor by the suture initiates tipping of the
anchor and movement of an end surface on the anchor across a
leading end surface on an inserter member.
[0212] U.S. Pat. No. 5,921,986 entitled "Bone Suture" discloses an
anchor connected with a suture moved through a passage between
opposite sides of a bone. The anchor is then pivoted to change its
orientation. A second anchor is connected with the suture. While
tension is maintained in the suture, the suture is secured against
movement relative to the anchors. This may be done by tying the
suture or by using a suture retainer to hold the suture. A suture
retainer may be used in place of the second anchor.
[0213] U.S. Pat. No. 5,948,002 entitled "Apparatus and Method for
Use in Positioning a Suture Anchor" discloses an apparatus which
includes a tubular outer member and an inner or pusher member.
During assembly of the apparatus, a suture is positioned in a slot
in the outer member. During use of the apparatus, the slot
facilitates visualization of the position of the suture anchor
relative to body tissue. In addition, the slot facilitates
separation of the apparatus from the suture after the suture anchor
has been positioned in the body tissue. A suture anchor retainer
may be provided at one end of the tubular outer member to grip the
suture anchor and hold the suture anchor in place during assembly.
The tubular outer member may be utilized to guide a drill during
formation of an opening in body tissue and may be subsequently
utilized to guide movement of a suture anchor into the opening in
the body tissue.
[0214] U.S. Pat. Nos. 6,010,525; 6,159,234; and 6,475,230 entitled
"Method and Apparatus for Securing a Suture" disclose improved
method to secure a suture relative to body tissue. A suture
retainer is moved along first and second sections of a suture
toward the body tissue. When a predetermined minimum force is being
transmitted between the suture retainer and the body tissue, the
first and second sections of the suture are gripped with the suture
retainer by plastically deforming material of the suture retainer.
The material of the suture retainer cold flows under the influence
of force applied against the surface areas on the suture retainer.
One or more bends are formed in each of the sections of the suture
to increase the holding action between the suture retainer and the
sections of the suture. The bends may be formed by wrapping a turn
of the suture around a portion of the suture retainer. During
movement of the suture retainer toward the body tissue, the bends
are moved along the first and second sections of the suture.
[0215] U.S. Pat. No. 6,045,551 entitled "Bone Suture" discloses an
anchor connected with a suture moved through a passage between
opposite sides of a bone. The anchor is then pivoted to change its
orientation. A second anchor is connected with the suture. While
tension is maintained in the suture, the suture is secured against
movement relative to the anchors. This may be done by tying the
suture or by using a suture retainer to hold the suture. A suture
retainer may be used in place of the second anchor. The passage may
extend across a fracture in the bone. The passage may have either a
nonlinear or linear configuration. A tubular member may be
positioned in the passage with the tubular member extending into
portions of the passage on opposite sides of the fracture. Opposite
end portions of the tubular member may be disposed in a compact
outer layer of the bone. If desired, a member other than a suture
may be used as a force transmitting member between the two anchors.
The tubular member may be formed of bone.
[0216] U.S. Pat. No. 6,447,516 entitled "Method of Securing Tissue"
discloses a retainer member formed of bone which secures tissue
against movement relative to a portion of a bone in a patient's
body. The retainer member is utilized to form an opening in a
compact outer layer of a portion of the bone in the patient's body.
The retainer member formed of bone is advantageously enclosed in a
tubular member or sleeve to prevent breaking of the retainer member
during the forming of the opening in the bone. The extent of
movement of the retainer member into the bone in the patient's body
is determined as the retainer member is moved into the bone. A
suture may be connected with the retainer member and used to
connect tissue with the bone.
[0217] U.S. Pat. No. 6,592,609 entitled "Method and Apparatus for
Securing Tissue" discloses an anchor having a pointed end portion
may be utilized to form an opening in a bone in a patient's body.
The anchor is moved into the opening formed in the bone in the
patient's body with a suture connected to the anchor. The suture
may then be utilized to retain body tissue in a desired position
relative to the bone. The body tissue may be either hard or soft
body tissue. If desired the anchor may be utilized in conjunction
with layers of soft body tissue. When a suture is used it may be
secured by connecting a retainer with the suture. Alternatively,
sections of the suture may be interconnected. It is believed that
it may be preferred to secure the suture in place after at least a
predetermined tension has been established in the suture and/or a
predetermined force has been transmitted to the body tissue. The
suture may be secured in place by exposing a retainer to ultrasonic
vibratory energy or by applying the ultrasonic vibratory energy
directly to sections of the suture.
[0218] U.S. Pat. No. 6,635,073 entitled "Method of Securing Body
Tissue" discloses a process to secure a first body tissue with a
second body tissue. A first anchor is moved along a first path
through the first body tissue into the second body tissue. A second
anchor is moved along a second path through the first body tissue
into the second body tissue. A suture extending between the anchors
may be tightened by moving the second anchor along a path which
extends transverse to the path of the first anchor. The suture
which extends between the anchors may have free ends which are
connected with a suture retainer. The free ends of the suture may
be interconnected either before or after the anchors are moved
along the first and second paths. Alternatively, the suture may be
a continuous loop which extends between the two anchors. A guide
assembly may be provided to guide movement of the anchors along the
two paths. The paths along which the anchors move may intersect so
that the anchors may be interconnected at the intersection between
the two paths.
[0219] U.S. Pat. No. 6,719,765 entitled "Magnetic Suturing System
and Method" discloses an instrument and method for passing a
medical implement through tissue with magnetic forces. The
implement can be an implant, either permanent or temporary, and is
provided with a magnetic component. A magnetic field is established
and the magnetic component and/or magnetic field is manipulated to
drive the implant through tissue. Alternatively, the instrument
itself is the implement and includes at least one magnetic element
so that a magnetic field established by an external magnetic
generator drives the instrument through tissue. In another
embodiment, the instrument includes two magnetic elements that are
moveable with respect to one another and interaction between the
magnetic elements drives the instrument through the tissue.
Examples of applications of the present invention include a suture
passer and a tissue anchor.
[0220] Other fastener types and fastening methods are disclosed in
U.S. Patent Application Publication No. 2003/0181800, entitled
"Methods of Securing Body Tissue," which discloses an improved
method of securing body tissue performed with a robotic mechanism.
The robotic mechanism may be utilized to tension a suture with a
predetermined force and urge a suture retainer toward body tissue
with a predetermined force. Ultrasonic vibratory energy may be
transmitted to the suture retainer to effect a gripping of the
suture by the suture retainer. The body tissue may be secured with
a staple. Legs of the staple may be bonded together to secure the
staple. The legs of the staple may be bonded together by
transmitting ultrasonic vibratory energy to the legs of the staple.
A tissue positioning assembly may be used to hold the body tissue
in a desired position. Images of the body tissue being secured may
be obtained using various known devices including one or more
endoscopes, a fluoroscope, a magnetic resonance imaging device,
and/or other known imaging devices.
[0221] U.S. Pat. No. 7,094,251, entitled "Apparatus and Method for
Securing a Suture," discloses a suture retainer having an upper or
cover section and a lower or base section which cooperate to define
passages through which portions of a suture extend. Projections on
the cover section of the retainer extend into recesses on the base
section of the retainer. A center projection on the base section
extends between the two projections on the cover section. The
projections cooperate with surfaces on body sections of the cover
and base section of the retainer to position and grip portions of
the suture. The retainer may be moved along the portions of the
suture while the retainer is gripped by an applicator assembly. The
applicator assembly is operable to apply energy to the retainer to
bond end portions of the projections on the cover section to
bottoms of recesses in the base section of the retainer.
[0222] U.S. Patent Application Publication Nos. 2004/0230223 and
2004/0220616 and U.S. Pat. No. 7,329,263, entitled "Method and
Device for Securing Body Tissue," disclose sutures and suture
retainers positioned relative to body tissue. Energy, such as
ultrasonic vibratory energy, is utilized to heat the suture
retainer and effect a bonding of portions of the suture retainer to
each other and/or to the suture. Portions of the body tissue may be
pressed into linear apposition with each other and held in place by
cooperation between the suture and the suture retainer. The suture
retainer may include one or more portions between which the suture
extends. The suture retainer may include sections which have
surface areas which are bonded together. If desired, the suture may
be wrapped around one of the sections of the suture retainer. The
suture retainer may be formed with a recess in which the suture is
received. If desired, the suture retainer may be omitted and the
sections of the suture bonded to each other.
[0223] The characteristics and features of the fasteners and
fastening methods just described may be combined and integrated
with the devices and methods of the present invention. The above
cited patents and patent applications are incorporated herein by
reference.
[0224] Furthermore, the fasteners may be, but are not limited to,
degradable, biodegradable, bioerodible, bioabsorbable, mechanically
expandable, hydrophilic, bendable, deformable, malleable, riveting,
threaded, toggling, barbed, bubbled, laminated, coated, blocking,
pneumatic, one-piece, Morse taper single piece, multi-component,
solid, hollow, polygon-shaped, pointed, locking and unlocking,
self-introducing, knotless, and combinations thereof. Also, the
fasteners may include metallic material, polymeric material,
ceramic material, composite material, body tissue, synthetic
tissue, hydrophilic material, expandable material, compressible
material, heat bondable material, biocompatible adhesive, and
combinations thereof. Examples of body tissue include bone,
collagen, cartilage, ligaments, or tissue graft material like
xenograft, allograft, autograft, and synthetic graft material. The
fasteners may also be made from a porous matrix or mesh of
biocompatible and bioresorbable fibers acting as a scaffold to
regenerate tissue.
[0225] The fasteners may also be made of or have a coating made of
an expandable material. The material could be compressed then
allowed to expand. Alternatively, the material could be hydrophilic
and expand when it comes in contact with liquid. Examples of such
expandable materials are PEEK, ePTFE, and desiccated body tissue.
It is contemplated that the fasteners and implants of the present
invention may include any combination of materials and agents
disclosed herein. For example, a fastener may include combinations
of hydrophilic material, synthetic body tissue, collagen, synthetic
collagen, heat bonded material, biocompatible adhesive, and cells,
such as stem cells.
[0226] Moreover, the fasteners described herein and incorporated by
reference may include therapeutic substances to promote healing.
These substances could include antibiotics, hydroxypatite,
anti-inflammatory agents, steroids, antibiotics, analgesic agents,
chemotherapeutic agents, bone morphogenetic protein (BMP), tissue
inductive factors, demineralized bone matrix, collagen, growth
factors, autogenetic bone marrow, progenitor cells, calcium
sulfate, immo suppressants, fibrin, osteoinductive materials,
apatite compositions, germicides, fetal cells, stem cells, enzymes,
proteins, hormones, cell therapy substances, gene therapy
substances, and combinations thereof. These therapeutic substances
may be combined with the materials used to make the fasteners to
produce a composite fastener or implant. Alternatively, the
therapeutic substances may be impregnated or coated on the
fastener. Time-released therapeutic substances and drugs may also
be incorporated into or coated on the surface of the fastener. The
therapeutic substances may also be placed in a bioabsorbable,
degradable, or biodegradable polymer layer or layers.
[0227] In addition to including the materials and agents described
elsewhere herein, a fastener may take the configuration of an
integrated fastener and arm member. The flexible arm may be
incorporated into the fastener and extend therefrom. The arm may be
connected with an end portion of the fastener or with any portion
between the end portions, like the midpoint. The fastener and
flexible arm may include the same or different materials and/or
therapeutic agents. In use with the positioning device of the
present invention, the fastener may be positioned at the distal end
of the hook with the flexible arm extending from the fastener
either within the lumen of the hook or exterior to the hook. Once
the fastener is properly placed within the body, the flexible arm
may be positioned through or around tissue and/or an implant and
tensioned to compress and stabilize the tissue and/or implant.
Another fastener may be connected with the flexible arm to maintain
tension and position of the arm.
[0228] The sutures of the present invention may be made of metallic
material, non-metallic material, composite material, ceramic
material, polymeric material, copolymeric material, or combinations
thereof. The sutures may be degradable, biodegradable,
bioabsorbable, or nonbiodegradable. Examples of suture materials
are polyethylene, polyester, cat gut, silk, nylon, polypropylene,
linen, cotton, PLA, PGA, caprolactam, and copolymers of glycolic
and lactic acid. Preferably, the sutures are flexible or bendable.
They may be threadlike, monofilament, multifilament, braided, or
interlaced. The sutures may have a coating of therapeutic
substances or drugs. For example, the sutures may include
antibiotics, hydroxypatite, anti-inflammatory agents, steroids,
antibiotics, analgesic agents, chemotherapeutic agents, bone
morphogenetic protein, demineralized bone matrix, collagen, growth
factors, autogenetic bone marrow, progenitor cells, calcium
sulfate, immo suppressants, fibrin, osteoinductive materials,
apatite compositions, fetal cells, stem cells, enzymes, proteins,
hormones, and germicides.
[0229] With the fastener 52 and suture 56 on the distal end of the
flexible pushrod 54, the pushrod 54 is moved distally through the
lumen of the hook 24 until the fastener 52 is positioned generally
next to the distal opening of the bone passage 48, as seen in FIG.
4. The pushrod 54 may be advanced to push the fastener 52 beyond
the distal aperture 50 of the hook 24 or may be advanced to
position the fastener 52 partially in and partially out of the hook
24. In the latter configuration, the fastener 52 may be easily
withdrawn, if necessary, from the hook 24 by moving the pushrod 54
proximally.
[0230] Alternatively, the fastener 52 and suture assembly may be
assembled in the lumen prior to inserting the device in a patient.
For example, a suture may be threaded into the lumen from the
distal end of the hook 24, or may be inserted through the proximal
end as described above before inserting the hook into the patient's
body. This allows visual confirmation of that the fastener is in a
desired position before introducing it into the patient's body. The
hollow interior of the hook 24 may be sized to allow sutures to be
placed therethrough, but sufficiently small to preclude the
fastener 52 from entering it. The distal end may have a bracket or
assembly that holds the fastener 52 in a desired position. The
bracket or assembly may grip the fastener in place, such as by an
interference fit or with friction. In one embodiment, application
of tensioning forces to the suture helps hold the fastener 52 in a
desired position relative to the distal end of the hook 24.
[0231] As illustrated in FIG. 5, a suture claw or grabber 58 (which
may be referred to as a gripper rod) is positioned in the guide
channel 32 and through the bone passage 48. A hook, claw, or clip
60 (which may be referred to as a gripper) is attached to the
distal end of the suture claw 58. When the suture claw 58 is
inserted distally into the guide channel 32, the hook or clip 60
exits or at least partially exits the distal opening of the bone
passage 48. Since the fastener 52 is positioned near the distal
opening of the bone passage 48, the hook or clip 60 of the suture
claw 58 can grab or capture the suture 56 extending from the
fastener 52. The suture 56 may be grabbed by rotating the suture
claw 58 and allowing the suture 56 to wrap around the hook 60 at
the distal end of the suture claw 58. Alternatively, the suture 56
may be grabbed with a clip 60, like an alligator clip, which may be
activated from the proximal end of the suture claw 58. In another
embodiment, a spiral member, like a corkscrew, may be disposed on
the distal end of the suture claw. The suture claw may be twisted
to thereby allow the spiral member to grab the suture. It should be
understood that the suture claw should grab all the suture legs or
portions attached to the fastener. For example, in FIG. 5, there
are two suture legs extending from the fastener. Both legs should
be captured by the suture claw either simultaneously or
sequentially.
[0232] It is also contemplated that the fastener or suture may be
pulled or placed in position using magnetic or electromagnetic
force. For example, once a passage is drilled through tissue or an
implant, a magnet may be used to pull a suture through the passage.
Alternatively, when using a fastener with a flexible arm, the arm
may be pulled through the passage. In these embodiments, the suture
or flexible arm may include a material which is attracted to a
magnet.
[0233] As previously described, a passage may not need to be
pre-drilled into the tissue or bone. In this instance, the suture
claw may include a distal tip configured for penetrating into and
through the tissue. Using a self-introducing suture claw eliminates
the need to bore a passage through the tissue before pulling the
suture through the tissue.
[0234] In FIG. 6, the suture claw 58 is shown retracted from the
guide channel 32. As the suture claw 58 is retracted, it pulls the
suture and/or suture portions 56 from the lumen of the hook 24 and
into the guide channel 32. As seen in FIG. 7, the proximal ends of
the suture portions 56 may extend beyond the proximal end of the
guide channel 32 when the suture claw is fully retracted.
[0235] As illustrated in FIG. 8, the hook, handle, and drill sleeve
of the drill system are removed from the bone 30. The fastener 52
(not shown) is located on the distal side of the bone 30. The
suture 56 extends from the fastener 52 through the bone passage and
out the proximal opening of the bone or tissue passage. In FIG. 9,
another fastener 62 is placed around or otherwise connected with
the suture and/or suture portions 56. The suture 56 is tensioned,
and the fastener 62 is secured to the suture 56 to thereby
approximate the fracture and stabilize the bone 30. The tension of
the suture pulls on the fasteners 52 and 62 generally towards each
other, thereby applying pressure to the fractured bone or
tissue.
[0236] Another exemplary embodiment of the guidance and positioning
device 70 is illustrated in FIG. 10. The device 70 is shown
positioned around a fractured bone 30. It should be understood that
the device may be used to fasten any tissue type or combination of
tissues as described herein. The device 70 includes a generally
cylindrical handle 22 and a hookshaped elongated member 72 attached
to the handle 22. In this embodiment, the hook-shaped elongated
member 72 does not necessarily include a lumen extending
therethrough. The proximal portion of the hook-shaped member 72 may
be positioned generally parallel with the longitudinal axis of the
handle 22. The device 70 may include a lever, clip, set-screw,
button, spring, or latch 26 for securing and releasing the
hook-shaped elongated member 72. The lever 26 allows different
sized hooks to be placed in the handle 22. For example, the hooks
may be of different lengths, have different radii of curvature, or
have different types or sizes of bone engagement portions 28.
[0237] A guide slot 74 extends through the handle 22 generally
parallel with the longitudinal axis of the handle 22. The
longitudinal axis of the guide slot 74 is generally aligned with
the distal end of the hook-shaped member 72. The guide slot 74 and
hook-shaped member 72 are generally parallel and relatively close
to each other at and just distal to the handle 22. In this
configuration, a single, small, percutaneous incision may be made
in skin or other soft tissue to gain access to the fractured bone
or other tissue requiring fixation.
[0238] In use, the device 70 is positioned with the hook-shaped
portion 76 of the hook-shaped elongated member 72 placed next to
and around the tissue to be fastened. In FIG. 11, the hook-shape
portion 76 is placed around a fractured bone 30 (fracture not
shown). A drill system 36 is positioned in the guide slot. The
drill system 36 includes a headpiece 38 configured for attachment
to a drill 40. A drill bit 42 is positioned at the distal end of
the drill system 36. A drill stop 44 is located distal from the
headpiece 38 and prevents the drill bit 42 from penetrating too far
beyond the tissue to be drilled. The drill system 36 may be a
cannulated drill system. The drill system 36 is used to create a
passage 48 in the bone 30 from the proximal side of the bone 30 to
the distal side of the bone 30. The distal opening of the bone
passage 48 is generally near a socket 78 at the distal end of the
hook-shaped portion 76 of the elongated member 72.
[0239] As previously noted, a drill system may not be needed to
form a passage in the tissue. An elongated member with a distal tip
configured for penetrating through tissue may be placed in the
guide slot and used for passage through tissue. The elongate member
may be a guide wire, k-wire, needle, or like device.
[0240] FIG. 12 illustrates the socket 78 at the distal end of the
hook-shaped portion 76 of the elongated member. The socket 78 is
dimensioned and configured for holding and/or carrying a fastener
52. The socket 78 may be a hollow cylinder or any other
configuration capable of accepting a fastener 52. As seen in FIG.
11, the socket 78 is positioned at the distal end of the
hook-shaped member 72 such that the fastener 52 is generally
aligned with the distal opening of bone passage 48. The fastener
may include characteristics, materials, therapeutic substances,
coatings, or any other features as described herein. It is
contemplated that the socket may hold the fastener magnetically,
frictionally, with an interlocking mechanism such as a snap, with
adhesive, etc.
[0241] Next, as shown is FIG. 13, the drill system is removed from
the guide slot 74. A fastening member 80 is placed in the guide
slot 74 and through the passage in the bone 30. The fastening
member 80 is moved distally through the passage and inserted into
the fastener disposed in the socket at the distal end of the
hook-shaped member 72. The fastening member may be made of metal,
polymer, ceramic, composite, body tissue, or combinations thereof.
The fastening member may also include features, therapeutic agents,
and coatings similar to the fastener and suture described herein.
FIG. 14 illustrates one exemplary embodiment of the connection
between the fastening member 80 and the fastener 52. The distal end
of the fastening member includes a threaded portion 82, and the
fastener 52 includes a threaded hole. The fastening member 80 is
screwed into the fastener 52. Other examples of connecting the
fastening member and fastener include ball and socket, hook and
loop, mechanical expansion, material expansion, dovetail,
orientation change, heat bondable material, biocompatible adhesive,
and other similar connection means.
[0242] In the embodiment wherein a drill system is not used create
a passage in the tissue, the fastening member 80 may include a
sharp or pointed distal tip to allow the member to be moved through
the tissue, free of a passage. Using a self-introducing fastening
member may eliminate the need to pre-drill the passage in the
tissue.
[0243] As illustrated in FIG. 15, the guidance and positioning
device is removed from the bone 30. The fastener 52 (not shown) is
located on the distal side of the bone 30. The fastening member 80
extends through the bone passage and out the proximal opening of
the bone passage. In FIG. 16, another fastener 62 is placed around
the fastening member 80. The fastening member 80 is tensioned, and
the fastener 62 is secured to the fastener member 80 to thereby
approximate the fracture and stabilize the bone 30. Once again, the
tension of the fastening member pulls the fasteners toward each
other, which in turn causes pressure to be applied to the treated
bone or tissue.
[0244] It is further contemplated that the guidance and positioning
device 20, 70 may be used without a distal fastener. In this
embodiment, the device 20,70 is used to position a suture on the
backside or distal portion of the tissue. The suture claw, grabber,
or elongate member may be placed in the guide channel or guide slot
and moved distally toward the suture located at the distal end of
the hook. Using the suture claw, one or two sections of the suture
may be pulled through the tissue to the proximal side of the
tissue. The suture or sutures may be pulled through a pre-drilled
passage created by a drill system or may be pulled through a
passage created by a self-introducing suture claw. Once a portion
of the suture is positioned on the proximal side of the tissue
(e.g., a securing point), it may be tensioned and secured with a
fastener. Alternatively, the proximally extending suture section
may be fastened with another section of the suture extending from
the distal end of the hook and around the tissue. In this
embodiment a suture loop is formed with tissue caught or positioned
in the middle of the loop. The two sections of the suture may be
secured with a knot or a fastener.
[0245] FIGS. 17 and 18 illustrate exemplary embodiments of clamping
mechanisms for the guidance and positioning device. FIG. 17 shows a
tubular clamp member 84 connected with the handle 22 of the device
20,70. The clamp member 84 includes a lumen extending therethrough
for allowing passage of the drill system, suture claw, and suture
as previously described. The proximal portion of the clamp member
84 includes threads 86, a ratchet, or the like for advancing the
clamp member 84 into and out of the handle 22. The distal end of
the clamp member 84 may include a tissue pad 88 for contacting
tissue.
[0246] The tissue pad 88 may be integrally formed on the distal end
of the clamp member. For example, during fabrication of the clamp
member, its cross-section may initially be relatively the same size
along its length, including at the distal end. Subsequently, the
distal end may be deformed or flattened to have a larger cross
section.
[0247] Alternatively, the tissue pad 88 also may be connected to
the clamp member in a manner that allows it to rotate and/or
swivel. As the clamp member 84 is moved toward the bone or tissue,
some areas of the tissue pad 88 may begin to make contact even
though the clamp member 84 may require additional rotation or
advancement in order to obtain a desired amount of contact. If the
tissue pad 88 is able to rotate or swivel, it can adjust to the
contours of the bone or tissue while also reducing potential
abrasion.
[0248] The contact surface of the tissue pad 88 may be
substantially flat, as shown in FIG. 17, but it also may be curved
or have a different shape that may correspond generally to the
curvature or shape of the bone or tissue that it may contact. The
contact surface also may be deformable so that it can more easily
conform to an uneven surface of bone or tissue. The deformable
surface of the tissue pad may be formed from a layer of elastomeric
material (e.g., rubber or urethane), foam material, or any other
elastomeric material suitable for use in a surgical procedure.
[0249] In use, the device 20 is positioned about a bone, or other
tissue. The clamp member 84 is moved or rotated distally so that
the tissue pad 88 contacts the proximal side of the bone. Further
advancement of the clamp member 84 causes the tissue pad 88 to
apply pressure on the bone or tissue.
[0250] Teeth or other friction means 90 may be disposed on the
distal portion of the hook 24 to make contact with the distal side
of the bone so that when the clamp member 84 extended, the device
20 is clamped or held in position relative to the bone. The
contacting surface of the hook also may be modified or configured
in the manner described above for the tissue pad.
[0251] FIG. 18 shows another embodiment of a clamping mechanism.
The tubular clamp member 84 is slideably disposed or connected with
the handle 22 of the device 20,70. The clamp member 84 may also
include a lumen extending therethrough. A squeeze/finger grip 92 is
connected with the handle 22 for advancing and retracting the clamp
member 84 relative to the handle 22. When the squeeze grip 92 is
moved toward the handle 22, the clamp member 84 may be moved or
ratcheted distally thereby pressing the tissue pad 88 against the
bone or other tissue. In this configuration, the clamp member
functions like a come-along with detents and/or teeth. The squeeze
grip 92 may be moved away from the handle 22 to move the clamp
member 84 proximally, or a release button or spring or clip may be
activated to permit the clamp member 84 to move proximally. Teeth
or other friction means 90 may be disposed on the proximal side of
the socket 78. With the clamp member 84 extended, the device 70 is
held to the bone or other tissue between the tissue pad 88 and
teeth 90 or socket 78.
[0252] Other embodiments of the clamping mechanism are further
contemplated. For example, the guidance and positioning device
20,70 may include one or more inflatable members, such balloons. An
inflatable balloon may be positioned along the hook at a location
where the hook passes near the proximal surface of the tissue. That
is, the balloon may be located at the proximal end of the curved
portion of the hook. In a deflated configuration, the device may be
properly positioned by the physician. The balloon may then be
inflated to press against the proximal side of the tissue causing
the distal end of the hook to press against the distal side of the
tissue and thereby hold or lock the device in place. The balloon
may be inflated with air, gas, or liquid. Inflation may be made
manually with a hand pump, electrically with an electric pump or
battery-operated pump, or pneumatically with a pressure cartridge.
The balloon may also help guide the distal end of the hook into the
proper position. Multiple balloons may be inflated and/or deflated
together or separately to guide the hook. Also, the balloon(s) may
be used to create space in tissue.
[0253] In another example, the device 20,70 may include a balloon
at the distal end of the hook. Operation of the balloon may be
similar to as previously described; however, in the current
embodiment, the balloon may inflate to press against the distal
side of the tissue causing the proximal portion of the hook (which
may include a tissue pad or gripping teeth) to press against the
proximal side of the tissue to thereby hold the device in position.
Furthermore, two or more balloons may be used to position and hold
the device relative to the tissue. The plurality of balloons may be
located along the hook or guide channel and inflated together or
individually to properly align and hold the device in place. In
addition to holding the device relative to the tissue, the balloon
or balloons may compress the tissue, tissue elements, and/or
implant. With the tissue and/or implant compressed, a fastener or
other implant may be positioned within the body.
[0254] As illustrated in FIG. 19, the device 20,70 may include a
tensioning mechanism 94 to tension the suture 56 or fastening
member 80. The tensioning mechanism 94 may be attached to the
handle 22, tubular member 24, elongated member 72, or other
component of the device 20,70. After the suture 56 or fastening
member 80 is inserted through the passage in tissue, like a
fractured bone 30, the tensioning mechanism 94 may pull and tension
the suture 56 or fastening member 80 while a proximal fastener 62
is positioned to maintain the tension in the suture 56 or fastening
member 80. The tensioning mechanism 94 may be, but is not limited
to, two elements which pinch the suture 56 or fastening member 80
to pull it proximally or a spool which rotates to pull the suture
56 or fastening member 80. A tension gauge, strain gauge, read-out
display, tension limiter, and/or an audio or visual tension
indicator may be used to apply the proper tension to the suture or
fastening member. Also, measurement of the tension may be
accomplished with a spring, a radiofrequency emitting device,
and/or a sensor such as an electrical sensor, flexible sensor,
compressive sensor, piezoelectric sensor. Other examples of tension
applicators are disclosed in U.S. Pat. Nos. 6,010,525 entitled
"Method and Apparatus for Securing a Suture"; 6,447,516 entitled
"Method of Securing Tissue"; and 6,635,073 entitled "Method of
Securing Body Tissue." The above mentioned patents are hereby
incorporated by reference.
[0255] As further shown in FIG. 19, the distal portion 96 of the
tubular clamp member 84 may be offset or curved thereby exposing
the suture 56 or fastening member 80 between the fractured bone 30
and clamp member 84. The tubular clamp member 84 may include a
lumen extending therethrough with the lumen having an aperture at
or near the proximal end of the offset portion 96 or the distal end
of the straight section of the clamp member 84. The offset distal
portion 96 allows a fastener 62 to be placed around the suture 56
or fastening member 80 adjacent to the proximal side of the bone
30. When the suture 56 or fastening member 80 is tensioned with the
tensioning mechanism 94, the fastener 62 may be applied to maintain
the tension in the suture 56 or fastening member 80.
[0256] It is contemplated that the guidance and positioning device
of the present invention may include more than one hook or
elongated member for positioning multiple fasteners at the distal
side of tissue. For example, as illustrated in FIG. 43, the device
150 may include two hooks or elongated members 152 and 154 attached
to the handle 156 and positioned generally parallel to each other.
The handle 156 may then include two guide channels, slots, or pins
158 and 160, each being aligned with one of the distal ends of the
hook shaped tubular or elongated members. In this configuration,
two passages 162 and 164 may be drilled in tissue, like a fractured
bone 166, and two sutures or fastening members may be positioned
through the passages, tensioned, and secured. One passage 162 may
be non-linear while the other passage 164 may be linear. Having
multiple hooks and guide channels or slots allows a physician to
implant multiple fasteners thereby producing compression on the
implant or tissue, enhancing the healing environment, and allowing
for tissue ingrowth. The device with multiple hooks or pins may
also be used to position other implants disclosed herein, such as
adhesives, tissue scaffolds, medicaments, etc.
[0257] It is also contemplated that the device of the present
invention may be disposable or may be sterilized after use and
reused. The device may be partly disposable and partly reusable.
For example, the handle may be reusable and the hook and/or guide
channel may be disposable. Alternatively, the handle may be
disposable. The device, its components, fasteners, drill bits,
sutures, and other apparatus disclosed herein may be package in a
kit. The kit may be set-up of a specific procedure, such as repair
of a fractured bone, securing of an implant, approximating body
tissue, etc.
[0258] Positioning Implants
[0259] The present invention not only provides an instrument and
method for dynamic and rigid fastening of tissue, but it also
provides for the guidance and positioning of an implant within the
body. For example, the present invention may be utilized with
tissue scaffolds as described in U.S. Pat. No. 7,299,805, entitled
"Scaffold and Method for Implanting Cells," by Peter M. Bonutti.
Viable cells may be positioned on a support structure then
implanted within a body. One or more blood vessels may be connected
with the support structure to provide a flow of blood through the
support structure. The devices and methods of the present invention
may be used to guide and position the support structure within the
body and fasten the scaffold to tissue or another implant by way of
a sling support and/or strut. The above mentioned application is
hereby incorporated by reference.
[0260] Furthermore, the present invention may be used in
combination with a medical system for the administration of a
pharmaceutical agent in vivo to a patient. The medical system may
include an implant positionable in a body of a patient. A
pharmaceutical agent may be disposed on the medical implant and at
least partially coated with a reactive coating. The reactive
coating acts to control the release of the pharmaceutical agent. An
energy unit may be provided for transmitting an energy signal to
the reactive coating, wherein the reactive coating reacts to the
energy signal to control the release rate of the pharmaceutical
agent. Additionally, the energy unit may also heat up the treatment
site, locally increasing vascularity at the treatment site and
allowing thermal necrosis of tissue. The localized increasing in
temperature increases the permeability of the local tissue,
allowing for an increased and more efficient adsorption of the
pharmaceutical agent into the treatment site. Additionally, in
response to localized increase in temperature, which can be
perceived as physical damage or an infection to the local area, the
local cells may release beneficial proteins, enzymes, hormones,
etc.
[0261] In another embodiment, a pharmaceutical agent, drug, or
medicament may be delivered within the body using the positioning
device described herein. The hook and/or guide channel of the
positioning device may conduct the passage of a medicament to a
specific location within the body. The drug may be transported
through the lumen of the hook or guide channel or, alternatively,
may be placed on the exterior of the hook or guide channel. When
the positioning device has been properly aligned, the medicament
may be released in a constant stream or in a pulsatile manner.
Examples of medicaments that may be used with the present invention
include those disclosed throughout this application and,
additionally, but not limited to, an anti-inflammatory agent,
non-proliferative agent, anti-coagulant, anti-platelet agent,
Tyrosine Kinase inhibitor, anti-infective agent, anti-tumor agent,
anti-leukemic agent, and combinations thereof. One or more
medicaments may be placed in one or more reservoirs which are in
fluid communication with the positioning device. The reservoir may
be physically separate from the device with tubing interconnecting
the device and reservoir. Alternatively, the reservoir may be
integrated into or attached to the positioning device. Release of
the medicament may be achieved through manual operation such as
with a plunger, air pressure, or valve or through electrical
operation such as with a pump or valve. The medicament may be
released from the positioning device or remotely away from the
device as with a radiofrequency or signal emitting device.
[0262] It is contemplated that an adhesive may be delivered within
the body in the way a medicament is delivered as described above.
The adhesive could a polysaccharide based adhesive, fibrin
adhesive, mollusc based adhesive, cyanoacrylate based adhesive,
polymeric based adhesive, or other biocompatible adhesive. The
adhesive could be thermally activated or pH activated. The adhesive
could be a single part adhesive or a two part adhesive requiring
both parts to activate the adhesive. The adhesive may also be
hydrophilic or include hydrophilic material. The hydrophilic
adhesive/material may expand upon imbibing liquid, such as body
fluid. In use, the adhesive may be delivered within the body to
bond tissue together such as soft tissue to soft tissue, soft
tissue to hard tissue, or hard tissue to hard tissue. For example,
portions of a fractured bone may be adhered, a muscle may be bonded
to other muscle or to a tendon, and a ligament may be adhered to
another ligament, to muscle, and/or to bone. The adhesive may also
be used to bond an implant with body tissue or to another implant.
For example, a bone or joint replacement component may be adhered
to another replacement component or to other bone, tissue
scaffolding with cells may be bonded to other tissue or other
scaffolding, and fasteners may be adhered to tissue or sutures.
[0263] In another embodiment, an energy sink, such as a pH sink,
may be incorporated into a medical implant or be positioned
separate from the medical implant. The pH sink is configured to
absorb energy from the energy unit, releasing a chemical to either
increase or decreasing the local pH. The change in local pH can
either increase or decrease the degradation rate of a degradable
polymer coating, which in turn can control the release rate of a
pharmaceutical agent. The pH sink can be formed from calcium
carbonate. Additionally, the localized change in pH created by the
pH sink has beneficial effects, which include (but are not limited
to): aiding in the alleviation of localized pain, fighting of local
infections, and increasing vascular flow and permeability of
vessels at the treatment site to control delivery of pharmaceutical
agent.
[0264] For example, a localized increasing in pH increases the
permeability of the local tissue, allowing for an increased and
more efficient adsorption of the pharmaceutical agent into the
treatment site. The energy sink may also be used to induce the
release of beneficial enzymes, proteins, hormones, etc. from the
cells in the treatment site. A localized increase in acidity and/or
temperature can be perceived as a physical damage or an infection
to the local area. In response, to the local cells may release
beneficial proteins, enzymes, hormones, etc. The positioning device
and method of the present invention may be used to guide and
position a drug-eluting implant, a heat sink, or pH sink within the
body.
[0265] The present invention may also be used with various
procedures for repairing, reconstructing, and stabilizing tissue
and implants within the body. Examples of such tissue include bone,
muscle, ligament, tendon, skin, organ, cartilage, and blood
vessels. Examples of implants include an organ, partial organ
grafts, tissue graft material (autogenic, allogenic, xenogenic, or
synthetic), a malleable implant like a sponge, mesh, bag/sac/pouch,
collagen, or gelatin, or a rigid implant made of metal, polymer,
composite, or ceramic. Other implants include breast implants,
biodegradable plates, metallic fasteners, rods, plates, screws,
screw strips, spacers, cages, compliant bearing implants for one or
more compartments of the knee, nucleus pulposus implant, stents,
meniscal implants, tissue grafts, tissue scaffolds, biodegradable
collagen scaffolds, polymeric or other biocompatible scaffolds,
abdominal hernia meshes, cochlear implants, tracheal implants,
small intestine submucosal grafts, TISSUEMEND scaffolds,
prostheses, nanotechnology devices, sensors, emitters,
radiofrequency emitting diodes, computer chips, RFID
(radiofrequency identification) tags, adhesives, and sealants.
[0266] Example devices and methods may provide for the repair,
reconstruction, augmentation, and securing of tissue and/or
implants during a surgical procedure and "on the way out" after the
surgical procedure has been performed but before the skin incision
has been closed. Tissue at and around the operation site and tissue
between the operation site and skin incision is rebuilt so that
tissue-function may be at least partially restored and the
operation region may be stabilized for enhanced healing.
[0267] The devices used to repair, reconstruct, augment, and/or
secure tissue or implants may be any biocompatible fastener
described herein or found in the prior art. Examples of fasteners,
implants, and their methods of employment may be found in U.S. Pat.
Nos. 5,163,960; 5,403,348; 5,441,538; 5,464,426; 5,549,630;
5,593,425; 5,713,921; 5,718,717; 5,782,862; 5,814,072; 5,814,073;
5,845,645; 5,921,986; 5,948,002; 6,010,525; 6,045,551; 6,086,593;
6,099,531; 6,159,234; 6,368,343; 6,447,516; 6,475,230; 6,592,609;
6,635,073; and 6,719,765. Other fastener types are disclosed in
U.S. patent application Ser. Nos. 10/102,413; 10/228,855;
10/779,978; 10/780,444; and 10/797,685. The above-cited patents and
patent applications are hereby incorporated by reference.
[0268] The fasteners may be, but are not limited to, degradable,
biodegradable, bioerodible, bioabsorbable, mechanically expandable,
hydrophilic, bendable, deformable, malleable, riveting, threaded,
toggling, barded, bubbled, laminated, coated, blocking, pneumatic,
one-piece, multi-component, solid, hollow, polygon-shaped, pointed,
self-introducing, and combinations thereof. Also, the fasteners may
include, but are not limited to, metallic material, polymeric
material, ceramic material, composite material, body tissue,
synthetic tissue, hydrophilic material, expandable material,
compressible material, heat bondable material, and combinations
thereof.
[0269] The fasteners of the present invention may be linear
fixation fasteners. Such fasteners secure tissue or an implant with
access to only one side of the tissue or implant. Generally, the
fastener is advanced through the tissue or implant, usually through
a pre-made passage or without a passage when the fastener is
self-introducing. Once placed through the tissue or implant, a
distal portion of the fastener expands, biases outward, or changes
configuration such that the distal portion prevents the fastener
from being pulled back out of the tissue or implant. The proximal
portion of the fastener is secured thereby anchoring the tissue or
implant. Examples of linear fixation fasteners are further
disclosed in the incorporated references.
[0270] The methods and devices of the present invention may be used
in conjunction with any surgical procedure of the body. The repair,
reconstruction, augmentation, and securing of tissue or an implant
may be performed in connection with surgery of a joint, bone,
muscle, ligament, tendon, cartilage, capsule, organ, skin, nerve,
vessel, or other body part. For example, tissue may be repaired,
reconstructed, augmented, and secured during and "on the way out"
following intervertebral disc surgery, knee surgery, hip surgery,
organ transplant surgery, bariatric surgery, spinal surgery,
anterior cruciate ligament (ACL) surgery, tendon-ligament surgery,
rotator cuff surgery, capsule repair surgery, fractured bone
surgery, pelvic fracture surgery, avulsion fragment surgery, hernia
repair surgery, and surgery of an intrasubstance ligament tear,
annulus fibrosis, fascia lata, flexor tendons, etc.
[0271] Also, tissue may be repaired after an implant has been
inserted within the body. Such implant insertion procedures
include, but are not limited to, partial or total knee replacement
surgery, hip replacement surgery, bone fixation surgery, etc. The
implant may be an organ, partial organ grafts, tissue graft
material (autogenic, allogenic, xenogenic, or synthetic), collagen,
a malleable implant like a sponge, mesh, bag/sac/pouch, collagen,
or gelatin, or a rigid implant made of metal, polymer, composite,
or ceramic. Other implants include breast implants, biodegradable
plates, porcine or bovine patches, metallic fasteners, compliant
bearing for medial compartment of the knee, nucleus pulposus
prosthetic, stent, tissue graft, tissue scaffold, biodegradable
collagen scaffold, and polymeric or other biocompatible scaffold.
The scaffold may include fetal cells, stem cells, embryonal cells,
enzymes, and proteins.
[0272] The present invention further provides flexible and rigid
fixation of tissue. Both rigid and flexible fixation of tissue
and/or an implant provides compression to enhance the healing
process of the tissue. A fractured bone, for example, requires the
bone to be realigned and rigidly stabilized over a period time for
proper healing. Also, bones may be flexibly secured to provide
flexible stabilization between two or more bones. Soft tissue, like
muscles, ligaments, tendons, skin, etc., may be flexibly or rigidly
fastened for proper healing. Flexible fixation and compression of
tissue may function as a temporary strut to allow motion as the
tissue heals. Furthermore, joints which include hard and soft
tissue may require both rigid and flexible fixation to enhance
healing and stabilize the range of motion of the joint. Flexible
fixation and compression of tissue near a joint may provide motion
in one or more desired planes. The fasteners described herein and
incorporated by reference provide for both rigid and flexible
fixation.
[0273] Exemplary Fasteners
[0274] The following Examples 1 through 8 which illustrate uses of
the present invention are for illustrative purposes and are not
limiting examples. As mentioned above, any fastener disclosed
herein or incorporated by reference may be used with the exemplary
methods. To simplify the disclosure of the present invention, a
limited number of fastener types will be used to illustrate the
exemplary methods. For example, the fasteners disclosed in U.S.
Pat. No. 5,921,986 will be used to represent any disclosed or known
fastener.
[0275] As described in the above-mentioned patent, the fasteners
may be placed against tissue, and a suture may be looped through
the tissue with the ends of the suture positioned within the
fasteners. The suture is tensioned, and the ends of the suture are
secured using a knot or any other suitable means for maintaining
the tension of the suture between the fasteners. The tensioning of
the suture, or similar cable, pin, thread, etc., may be controlled
and monitored with sensor technology, like a magnetic sensor, which
may unload the pressure if necessary. Other known tensioning
apparatus may also be utilized. For example, the tensioning system
may be spring loaded, pneumatic, electrical, pisoelectric, and
magnetic. The tensioning system may be connected with an introducer
or cannula or may be part of a fastener or implant. The tensioning
system may include a read-out display outside the body. The
read-out display may receive tension data through radiofrequency
energy, infrared energy, or other suitable energy source.
[0276] Additionally, two or more fasteners may be utilized to
secure body tissue and/or an implant. When two fasteners are used,
one fastener is placed against or within one tissue area and the
second fastener is placed against or within another tissue area.
The suture is looped through one fastener while the ends of the
suture are positioned within the second fastener. The suture is
tensioned and the ends fastened with a knot or fastened using a
device or method disclosed herein or incorporated by reference. In
this configuration, the suture includes two generally parallel legs
or portions located between the fasteners. Furthermore, when two
fasteners are used, a single suture may be employed leaving only
one leg between the fasteners. In this configuration, each end of
the suture is positioned in different fasteners. The suture may be
tensioned and the ends secured. It is further contemplated that the
fasteners and sutures may be inserted through a passage in the
tissue or implant. For example, a passage may be drilled through
tissue or implant for insertion of the fastener or suture. With the
fastener in place, these passages may be packed or filled with
tricalcium phosphate (TCP), calcium phosphate, a thermal polymer,
polymethyl methacrylate (PMMA) with hydroxyaptite (HA), polylactic
acid (PLA) with HA, and other suitable materials. These materials
may harden within the passage and would provide additional
stabilization of the tissue or implant.
[0277] FIGS. 20A-20F illustrate exemplary fasteners 630 with at
least one channel 632. In an exemplary embodiment, FIG. 20A shows a
generally cylindrical shaped fastener 630a. Two channels or slots
632a for receiving a suture or other similar filament extend
through the fastener 630a and are generally perpendicular to the
longitudinal axis 634 of the fastener 630a. FIG. 20B shows a
generally half cylindrical shaped fastener 630b. The fastener 630b
includes a generally flat surface 636 on one side and an arched
surface 638 on the other side. The flat surface 636 may be placed
against the tissue or implant to provide increased contact area.
FIG. 20C shows a cylindrical shaped fastener 630c with a
hemispheric or concave surface 640 on one side. This surface 640
may be placed against an implant or tissue, like a bone, which has
a convex surface, so that the concave surface 640 of the fastener
630c and the convex surface of the tissue/implant are in contact.
FIG. 20D shows a generally rectangular fastener 630d. The fastener
630d may have a thickness which minimizes protrusion of the
fastener 630d from the outer surface of the tissue or implant which
it is positioned against.
[0278] Although the exemplary fasteners have been described as
generally longitudinal members, it is also contemplated that the
fasteners can take the form of a square, oval, sphere, button, or
any other suitable configuration.
[0279] FIG. 20E shows a fastener assembly 630e having a plurality
of fastener members 642 positioned generally parallel to each other
with connecting members 644 between them. The fastener members 642
may take the form of any shape described herein or incorporated by
reference. The connecting members 644 attach the fastener members
642 to each other. The connecting members 644 may be hingedly or
pivotally connected with the fastener members 642 to allow the
fastener assembly 630e to flex or bend. Alternatively, the
connecting members 644 may be made of a flexible material such as a
suture, wire, cable, or thread, which could flex or bend. In an
exemplary embodiment, the channels 632e of the fastener members 642
are positioned such that a row of channels 646 are aligned over one
portion of tissue located on one side of an incision while another
row of channels 648 are aligned over the other portion of the
tissue located on the opposite side of the incision. Multiple
sutures may be used with the fastener assembly for securing tissue
or an implant.
[0280] Alternatively, the fastener members 630e may be connected
with one another with a flexible strip 650. As seen in FIG. 20F,
four fastener members 642 are affixed to the flexible strip 650 and
are generally parallel to each other and spaced apart from each
other. The strip 650 may be handled and placed against tissue or an
implant thereby positioning all the fastener members 642 at about
the same time. In this regard, the flexible strip 650 can be made
of or include graft material such as collagen, demineralized bone,
etc. The flexible strip 650 may be expandable, hydrophilic,
bioabsorbable, bioerodible, degradable, biodegradable, or
combinations thereof. It may include a therapeutic substance such
as antibiotics, hydroxypatite, anti-inflammatory agents, steroids,
antibiotics, analgesic agents, chemotherapeutic agents, bone
morphogenetic protein, demineralized bone matrix, collagen, growth
factors, autogenetic bone marrow, progenitor cells, calcium
sulfate, immo suppressants, fibrin, osteoinductive materials,
apatite compositions, fetal cells, stem cells, enzymes, proteins,
hormones, germicides, and combinations thereof.
[0281] The flexible strip 650 may also include an adhesive on one
side to adhere the fastener members 642 to the strip 650 and may
further include adhesive of the other side to adhere the strip 650
to tissue or implant. Such adhesives may include cyanoacrylate
adhesives, hydrogel adhesives, monomer and polymer adhesives,
fibrin, polysaccharide, Indermil.RTM. or any other biocompatible
adhesive.
[0282] FIG. 20G shows another fastener assembly 630g of the present
invention. This fastener assembly 630g is generally L-shaped or
J-shaped. Like the fastener assemblies of FIGS. 20E and 20F, the
fastener members 642 of FIG. 20G may be attached to one another
with connecting members 644 or with a flexible strip 650. FIG. 20H
shows a U-shaped fastener assembly 630h for closing a U-shaped
incision in tissue, like those frequently made in the annulus. The
rows of channels 646 and 648 of the fastener members 642 are
arranged as described herein, with one line of channels 646 on one
side of the incision and the other line of channels 648 of the
other side of the incision.
[0283] The type and shape of the incision determine the size and
configuration of the fastener assembly used. For example, a
U-shaped incision could be closed with a U-shaped fastener assembly
630h, and an L-shaped incision could be closed with an L-shaped
fastener assembly 630g. The suture or sutures used with the
fastener assemblies may be tensioned and secured with a knot, or
alternatively may be secured with devices and methods described
herein and those incorporated by reference.
[0284] The exemplary fasteners may be utilized with one or more
sutures, filaments, cables, or other similar implant. Generally,
one suture may be used for the fasteners of FIGS. 20A-20D when only
one fastener is employed. When two or more fasteners of FIGS.
20A-20D are used, multiple sutures may be employed. Similarly, the
fasteners of FIGS. 20E-20H may use multiple sutures. The ends of
sutures may be placed through the channels of the fastener members,
and the sutures tensioned. Alternatively, a single suture could be
used. That is, the single suture may be threaded in and out of the
channels of the fastener members to secure tissue or an
implant.
[0285] The exemplary fasteners and fastener assemblies of the
present invention may be formed of any natural or artificial
material. For example, they may be formed from material which is
polymeric, metallic, composite, ceramic, or combinations thereof.
Furthermore, the fasteners and assemblies may be made of body
tissue including bone, collagen, cartilage, ligaments, or tissue
graft material like xenograft, allograft, and autograft. They may
be bioabsorbable, bioerodible, degradable, biodegradable,
mechanically expandable, hydrophilic, and combinations thereof. The
fasteners and assemblies may be made from a porous matrix or mesh
of biocompatible and bioresorbable fibers acting as a scaffold to
regenerate tissue.
[0286] The fasteners and assemblies may also be made of or have a
coating made of an expandable material. The material could be
compressed then allowed to expand once sutured to tissue or an
implant. Alternatively, the fastener and assembly material could be
hydrophilic and expand when it comes in contact with liquid.
Examples of such expandable materials are desiccated body tissue,
foam, and expandable polymers.
[0287] Furthermore, the fasteners, fastener assemblies, and
implants described herein and incorporated by reference may include
therapeutic substances to promote healing. These substances could
include antibiotics, hydroxypatite, anti-inflammatory agents,
steroids, antibiotics, analgesic agents, chemotherapeutic agents,
bone morphogenetic protein (BMP), demineralized bone matrix,
collagen, growth factors, autogenetic bone marrow, progenitor
cells, calcium sulfate, immo suppressants, fibrin, osteoinductive
materials, apatite compositions, germicides, fetal cells, stem
cells, enzymes, proteins, hormones, cell therapy substances, gene
therapy substances, and combinations thereof. These therapeutic
substances may be combined with the materials used to make the
fasteners to produce a composite fastener or implant.
Alternatively, the therapeutic substances may be impregnated or
coated on the fastener or implant. Time-released therapeutic
substances and drugs may also be incorporated into or coated on the
surface of the fastener or implant. The therapeutic substances may
also be placed in a bioabsorbable, degradable, or biodegradable
polymer layer or layers.
[0288] The sutures of the present invention may be made of metallic
material, non-metallic material, composite material, ceramic
material, polymeric material, copolymeric material, or combinations
thereof. The sutures may be degradable, biodegradable,
bioabsorbable, or non-biodegradable. Examples of suture materials
are polyethylene, polyester, cat gut, silk, nylon, polypropylene,
linen, cotton, and copolymers of glycolic and lactic acid. In an
exemplary embodiment, the sutures are flexible or bendable. They
may be threadlike, monofilament, multifilament, braided, or
interlaced. The sutures may have a coating of therapeutic
substances or drugs. For example, the sutures may include
antibiotics, hydroxypatite, anti-inflammatory agents, steroids,
antibiotics, analgesic agents, chemotherapeutic agents, bone
morphogenetic protein, demineralized bone matrix, collagen, growth
factors, autogenetic bone marrow, progenitor cells, calcium
sulfate, immo suppressants, fibrin, osteoinductive materials,
apatite compositions, fetal cells, stem cells, enzymes, proteins,
hormones, and germicides.
[0289] FIGS. 21A-21C illustrate exemplary embodiments of another
fastener 652. The fastener or tubular member or sleeve 652a in FIG.
21A is generally tubular shaped having a wall 654 with an inner
surface 656 and an outer surface 658. The inner surface 656 defines
a lumen 660 which is dimensioned and configured for receiving a
suture, cable, K-wire, or similar device. In another embodiment,
FIG. 21B shows a sleeve 652b with a slit 662 through the tubular
wall 654. The slit 662 allows the sleeve 652b to be decreased in
diameter for implantation and increased in diameter after
implantation for proper alignment of the implantation site. In a
further embodiment, the sleeve 652c of FIG. 21C includes two slits
662 in the tubular wall 654 thereby forming two semi-tubular
members. The semi-tubular members may be placed separately at the
implantation site then aligned to form a complete tubular member.
In another embodiment, the tubular member is a solid member.
[0290] The tubular member may be flexible to enable the tubular
member to be inserted into a nonlinear passage through the bone.
The tubular member may be formed of metallic material, composite
material, ceramic material, polymeric material, or combinations
thereof. The tubular member may be made from a degradable,
biodegradable, bioerodible, or bioabsorbable material, such as a
polymer, composite, or ceramic. The tubular member may also include
a therapeutic substance to form a composite tubular member, or the
therapeutic substance may be coated onto the tubular member.
Furthermore, therapeutic substances or graft material (autogenic,
allogenic, xenogenic, or synthetic) may be packed into the tubular
member.
[0291] Additionally, the outer surface 658 of the tubular member
652 may include a friction or gripping means. FIG. 21D shows a
portion of the outer surface 658 of the tubular member with threads
664. In FIG. 21E, the outer surface 658 includes raised pebbles, or
bumps 666. FIG. 21F illustrates raised ridges or hills 668 around
the outer surface 658. In addition to a friction means on the outer
surface of the tubular member, the wall of the sleeve may include
openings 670 for tissue ingrowth, as shown in FIG. 21G. It is
contemplated that any of the fasteners, fastener assemblies, and
implants disclosed herein and incorporated by reference may also
include a friction or gripping means as described above.
[0292] It is further contemplated that tissue and implants may be
secured with biologic adhesive, or fasteners disclosed herein and
incorporated by reference may be used with the biologic adhesive.
Such adhesives may include cyanoacrylate adhesives, hydrogel
adhesives, monomer and polymer adhesives, fibrin, polysaccharide,
Indermil.RTM. or any other biocompatible adhesive. For example,
tissue scaffolds and tissue welding fasteners disclosed herein or
incorporated by reference may be used with adhesive and an energy
source, like ultrasound, RF, laser, electromagnet, ultraviolet,
infrared, electro-shockwave, or other suitable energy source, to
activate or deactivate the adhesive.
Example 1
Intervertebral Disc Repair
[0293] As previously described, the present invention provides
devices and methods for fastening body tissue and/or an implant.
One example is the fastening or repair of ligamentous tissue.
Ligamentous tissue is found, among other locations, within
intervertebral discs of the spinal column. The spinal column is
formed from a number of vertebrae which are separated from each
other by intervertebral discs. The intervertebral discs stabilize
and distribute force between the many vertebrae. As used herein,
"spinal joint" or joint of the spine includes this intervertebral
space.
[0294] Generally, intervertebral discs are made of a soft, central
nucleus pulposus surrounded by a tough, woven annulus fibrosus.
Herniation of a disc is a result of a weakening in the annulus.
Symptomatic herniations occur when weakness in the annulus allows
the nucleus pulposus to bulge or leak posteriorly toward the spinal
cord and major nerve roots. One treatment of a herniated,
displaced, or ruptured intervertebral disc is a discectomy. This
procedure involves removal of disc materials impinging on the nerve
roots or spinal cord posterior to the disc. Depending on the
surgeon's preference, a varying amount of nucleus pulposus is
removed from within the disc space either through the herniation
site or through an incision in the annulus. In addition to a
discectomy, other surgical procedures where the present invention
may be used include a vertebroplasty and kyphoplasty.
[0295] FIG. 22 illustrates an exemplary embodiment of repairing an
intervertebral disc 680. The disc 680 is located between a superior
vertebra 682 and an inferior vertebra 684. During a discectomy, an
incision 686A is made through the annulus fibrosus 688 for the
removal of all or a portion of the nucleus pulposus 690. After the
appropriate amount of the nucleus 690 has been removed, the
incision 686A is approximated. In one embodiment showing the
closing of the incision 686A, a fastener 630A is positioned
generally transverse to the incision 686A. The fastener 630A is
positioned on the outer surface of the annulus 688 with one channel
632 on one side on the incision 686A and the other channel 632 on
the other side of the incision 686A. A suture 700A is positioned
through the portions of annulus 688 located on opposite sides of
the incision 686A in a generally U-shaped, looped, or curved
configuration. The ends of the suture 700A are placed within the
channels 632 of the fastener 630A and tensioned to draw together
the two portions of the annulus 688 on opposite sides of the
incision 686A. The suture 700A is secured to the fastener 630A with
a knot or other means disclosed herein or incorporated by
reference. Depending on the length of the incision, a plurality of
fasteners and sutures may be used to fully close the incision.
[0296] One or more additional incisions 686B in the annulus 688 may
be necessary for increased access to the nucleus 690. These other
incisions will also need to be approximated. As seen in FIG. 22,
one fastener 630B is placed on one side of the incision 686B
generally parallel to the incision 686B. A second fastener 630C is
positioned on the other side of the incision 686B. Closure of the
incision 686B is accomplished by placing a suture or sutures
through the annulus 688 so that the annulus portions on opposite
sides of the incision 686B are drawn together when the suture is
tensioned. The ends of the suture are secured by the fasteners
630B, 630C. Depending on the length of the incision, more than two
fasteners may be utilized to approximate the incision. The closure
of the incision enhances the natural healing and reconstruction of
the annulus wall.
[0297] While the incisions of FIG. 22 are generally linear, other
incision configurations may be made for increased accessibility
through the annulus. For example, the incision may be circular,
L-shaped, U-shaped, C-shaped, J-shaped, etc. Different
configurations and types of fasteners illustrated in FIG. 20 may be
used to close these non-linear incisions. Furthermore, these
incisions may be made anywhere along the annulus (posterior,
anterior, or sides) or between the annulus and vertebral body.
[0298] It is further contemplated that access to the nucleus
pulposus may be obtained through a vertebral body. A channel(s) or
passage(s) 692 may extend from the outer side surface of the
vertebral body to the adjacent nucleus. The channel may be formed
with a bone drill bit and/or a tissue harvesting device as
described in U.S. Pat. No. 5,269,785 entitled Apparatus and Method
for Tissue Removal, which is hereby incorporated by reference. The
nucleus pulposus material may be fully or partially removed through
the channel 692. Means for removing the material may include
suction, scrapper, scooper, syringe, or other similar device. When
no new material is required to be implanted in the region where the
nucleus pulposus material was removed, the physician may close the
channel 692 with graft material such as autograft material,
allograft material, and/or other implantable materials disclosed
herein. Alternatively, a plug/seal 693 made of metal, polymer,
composite, or ceramic may be inserted into the channel 692 at
either end of the channel or at both ends of the channel. The plug
693 may be removable for gaining access to the nucleus pulposus
during a subsequent surgery. In this method, the annulus fibrosus
is not incised, punctured, or weakened thereby reducing the healing
time of the disc.
[0299] Depending on the severity of herniation or damage to the
disc, nucleus pulposus replacement material or a nucleus pulposus
prosthesis may be positioned between a superior vertebra and
inferior vertebra. One or more incisions may be made through the
annulus for access to the nucleus. The nucleus pulposus may be
removed, and the replacement material or prosthesis may be
inserted. Alternatively, the nucleus pulposus also remain in place
with the replacement material or prosthesis positioned next to or
along with the existing nucleus pulposus. Furthermore, the nucleus
pulposus can be removed, conditioned or treated, and then
re-implanted either alone or with a replacement material. In this
regard, the temporarily removed nucleus pulposus can serve as a
scaffold seeded with cells or treated with a growth factor or any
other of the therapeutic agents disclosed herein. The fasteners and
sutures of the present invention may be used to approximate the
annulus incisions. Any number of fasteners may be used to fully
close the incision.
[0300] The nucleus pulposus replacement material or prosthesis may
also be positioned between the superior and inferior vertebrae
through a vertebral body. As mentioned previously, a passage or
channel may be made through the vertebral body extending from the
outer surface to the adjacent nucleus pulposus. All, some, or none
of the existing nucleus pulposus may be removed prior to insertion
of the replacement material or prosthesis. In an exemplary
embodiment, the replacement material is injected through the
incision or channel in the vertebra and into the nucleus pulposus
area. This material may be flowable for injection then once
injected may become less flowable to form a gel-like material or,
alternatively, may become generally solid to form a rubber-like
material. Additionally, the nucleus pulposus replacement material
may be flowable or injected into a balloon or bladder which may be
positioned between adjacent vertebral bodies.
[0301] In another embodiment, the replacement material or
prosthesis may be rubber-like or gel-like pellets having a
configuration which allows them to be passed through the incision
or channel. The replacement material or prosthesis may be
expandable so that, once inserted, it can fill the implant area.
The materials or prosthesis may include an adhesive and/or
therapeutic substances, like antibiotics, hydroxypatite,
anti-inflammatory agents, steroids, antibiotics, analgesic agents,
chemotherapeutic agents, bone morphogenetic protein, demineralized
bone matrix, collagen, growth factors, autogenetic bone marrow,
progenitor cells, calcium sulfate, immo suppressants, fibrin,
osteoinductive materials, apatite compositions, fetal cells, stem
cells, enzymes, proteins, hormones, and germicides.
[0302] Surgery of the intervertebral disc may leave the spine with
increased motion or shear which can cause further disc failure,
facet hypertrophy, or arthritis of the facet joints. To stabilize
the repaired intervertebral disc "on the way out," the devices and
methods of the present invention may be utilized. Flexible fixation
of tissue at and near the operation site may allow compression of
tissue and limited motion of the repaired intervertebral disc
allowing ligaments, the annulus fibrosis, interspinous ligaments,
and other soft tissue to properly heal. Stabilizing one vertebral
body to another vertebral body under compression would still allow
for some range of motion of the joint yet prevent disc
degeneration.
[0303] The vertebral bodies may be stabilized anteriorly and/or
posteriorly or with a hybrid approach such as an anterior-lateral
or posterior-lateral approach. For example, on the anterior side of
the spine, two fasteners 630D, 630E are positioned to secure the
ends of a suture 700B placed through the intervertebral disc 680
and through adjacent vertebrae 682 and 684 in a curved or looped
configuration. Two other fasteners 630F, 630G are positioned
against or within the vertebrae 682 and 684 to hold the ends of a
suture or sutures 700C placed through the disc 680 and through the
adjacent vertebrae 682 and 684 in a generally straight
configuration. Two more fasteners 630H, 6301 are positioned against
or within two vertebrae 702 and 704 located a distance from the
repaired disc 680. A suture or sutures 700D are placed between
these vertebrae 702 and 704 and tensioned. These fasteners and
sutures provide stability and an enhanced healing environment for
the intervertebral disc.
[0304] Finally, FIG. 22 illustrates another exemplary embodiment
for stabilizing tissue around a repaired tissue region. One
fastener 630J is positioned against or within an upper spinous
process 706 adjacent the repaired disc 680, while another fastener
630K is positioned against or within a lower spinous process 708
also adjacent the repaired disc 680. A suture or sutures 700E are
placed between the fasteners 630J, 630K and tensioned. This
configuration and placement of fasteners and sutures limits or
prevents the movement of the repaired disc.
Example 2
Intervertebral Disc Replacement
[0305] A damaged intervertebral disc may require replacement
instead of just minor repair. The disc may be replaced with a
prosthetic disc which may include a biocompatible material such as
metal, polymer, composite, ceramic, or combinations thereof. FIG.
23 illustrates a total intervertebral disc replacement using the
devices and methods of the present invention. While a disc
replacement is shown and described below, it is contemplated that
any skeletal region, like a joint, may be fitted with an implant,
and the implant fastened and stabilized with the sutures,
fasteners, and methods disclosed herein and incorporated by
reference. For example, a knee replacement component may be affixed
to the femur, tibia, or patella in accordance with the following
described methods.
[0306] A disc replacement component may be positioned between the
lower surface of a superior vertebra and the upper surface of an
inferior vertebra. In this configuration, the disc replacement
component takes the place of the original intervertebral disc and
provides the proper spacing between the vertebrae. Such a disc
component may be anchored to the surfaces of the superior and
inferior vertebrae with the fasteners and sutures described herein
and incorporated by reference.
[0307] Alternatively, and as shown in FIG. 23, the disc replacement
implant 710 may be larger in height than the normal height of an
intervertebral disc. The implant 710 may include upper 712, middle
714, and lower 716 sections. The upper and lower sections 712 and
716 are made of a biocompatible material which allows integration
of the bone tissue of the vertebral bodies. This material may be
polymeric, composite, metallic, ceramic or combinations thereof.
Furthermore, the material may be body tissue including bone,
collagen, cartilage, ligaments, or tissue graft material. The
material may be bioabsorbable, bioerodiable, degradable, and/or
biodegradable.
[0308] The upper and lower sections 712 and 716 of the disc
replacement component 710 may include therapeutic substances, like
antibiotics, hydroxypatite, anti-inflammatory agents, steroids,
antibiotics, analgesic agents, chemotherapeutic agents, bone
morphogenetic protein, demineralized bone matrix, collagen, growth
factors, autogenetic bone marrow, progenitor cells, calcium
sulfate, immo suppressants, fibrin, osteoinductive materials,
apatite compositions, fetal cells, stem cells, enzymes, proteins,
hormones, and germicides. Finally, the upper and lower sections 712
and 716 may include an expandable material. This material could be
compressed then allowed to expand once implanted. Alternatively,
the material could be hydrophilic and expand when it comes in
contact with liquid. Examples of such expandable materials are
desiccated body tissue, foam, and expandable polymers.
[0309] The middle section 714 of the disc implant 710 includes a
flexible or resilient material. The middle section 714 functions as
the original intervertebral disc. Materials which may be used in
the middle section 714 include rubber, gel, foam, polymer,
collagen, body tissue, or other suitable material. The middle
section 714 may also include an expandable material. Furthermore,
therapeutic substances such as antibiotics, hydroxypatite,
anti-inflammatory agents, steroids, antibiotics, analgesic agents,
chemotherapeutic agents, bone morphogenetic protein, demineralized
bone matrix, collagen, growth factors, autogenetic bone marrow,
progenitor cells, calcium sulfate, immo suppressants, fibrin,
osteoinductive materials, apatite compositions, fetal cells, stem
cells, enzymes, proteins, hormones, and germicides may be included
in the middle section 114 of the disc replacement implant 710.
[0310] The disc implant 710 is positioned as follows. The superior
vertebra 718 may be cut to receive the upper section 712 of the
disc implant 710, while the inferior vertebra 720 may be cut to
receive the lower section 716 of the implant 710. The cuts may be
made from any side of the vertebral body. However, it is preferred
that cutting the vertebrae 718 and 720 results in minimal
disruption of the surrounding tendons, muscles, nerves, and
ligaments, like the anterior and posterior longitudinal ligaments.
The cuts may be planar and generally perpendicular to the
longitudinal axis of the spine. The cuts may also be multi-planar
such that the pedicles and facet joints are not affected or
weakened.
[0311] The upper, middle, and lower sections 712, 714, and 716 of
the implant 710 combine to form a height which when the implant 710
is positioned between the cut portions of the superior and inferior
vertebrae 718 and 720, is generally the same height of the normal
intervertebral disc and adjacent vertebral bodies. This technique
is analogous to a total knee replacement procedure. The femur,
tibia, and patella are cut and prepared for implant components.
Once affixed, the knee replacement components return the knee joint
to its normal height, configuration, and function. The spinal
implant 710 of the present invention is similar; it returns the
spinal column to its normal height and function.
[0312] To secure the disc implant 710 to the cut superior and
inferior vertebrae 682 and 684, the sutures, fasteners, and methods
of the present invention may be used. As seen in FIG. 23, a
fastener 630L is positioned within or against the superior vertebra
682, while a second fastener 630M is placed within or against the
upper section 712 of the disc implant 710. A suture 700F positioned
between the fasteners 630L, 630M is tensioned thereby anchoring the
implant 710 to the superior vertebra 682. In addition, a graft 720,
like a tissue graft, is positioned over the lower section 716 of
the implant 710 and the inferior vertebra 684. Two fasteners 630N,
6300 with sutures hold the graft 720 in place thereby anchoring the
implant 710 to the inferior vertebra 684. To help stabilize the
region around the disc implant 710, a first fastener 630P is
positioned within or against a spinous process 706, while a second
fastener 630Q is placed within or against a different spinous
process 708. A suture 700G extends between the fasteners 630P, 630Q
and is tensioned to limit movement of the spinous processes 706 and
708 and their relative vertebral bodies.
[0313] The disc implant 710 is further anchored to the superior and
inferior vertebrae 682 and 684 with fasteners, sutures, and tubular
members. Two fasteners 630R, 630S are positioned within or against
the vertebrae 682 and 684. Two other fasteners 630T, 630U are
placed within or against the disc implant. Sutures 700H, 7001 are
positioned within tubular members or sleeves 652A, 652B that extend
between the fasteners. The tubular members 652A, 652B may have a
thin cylindrical wall which engages the bone of the vertebrae 682
and 684 and material of the implant 710. By inserting the tubular
members 652A, 652B in such an orientation, the superior and
inferior vertebrae 682 and 684 and disc implant 710 are maintained
in alignment.
[0314] It is also contemplated that the tubular member or sleeve
may be placed within ligaments, tendons, muscles, bones, or
combinations thereof. For example, the tubular member may be
positioned in bones, including transverse process, pedicles,
facets, spinous process, posterior arch, odontoid process,
posterior tubercle, lateral articular process, uncinate process,
anterior tubercle, carotid tubercle, and vertebral body. The
tubular member may also be positioned in ligaments, including the
anterior longitudinal ligament, posterior longitudinal ligament,
interspinous ligaments, supraspinous ligament, ligamentum flavum,
intertransverse ligament, facet capsulary ligament, ligamentum
nuchae, and ligaments of the sacrum and coccyx spine.
[0315] Following intervertebral disc replacement, the spine and
surrounding tissue may be become weakened. To stabilize these
regions "on the way out," the devices and methods of the present
invention may be utilized. Flexible fixation of tissue at and near
the operation site may allow compression of tissue and limited
motion of the prosthetic intervertebral disc allowing ligaments,
the annulus fibrosis, interspinous ligaments, and other hard or
soft tissue to properly heal. Stabilizing one vertebral body to
another vertebral body under compression would allow for some range
of motion of the joint and prevent disc degeneration and reduce the
incidence of postoperative pain.
Example 3
Implant Anchoring
[0316] The devices and methods of the present invention may be
further used to stabilize an implant positioned within the body. In
addition to the type of implants mentioned elsewhere herein, the
implant may be an organ, partial organ grafts, tissue graft
material (autogenic, allogenic, xenogenic, or synthetic), a
malleable implant like a sponge, mesh, bag/sac/pouch, collagen, or
gelatin, or a rigid implant made of metal, polymer, composite, or
ceramic. Other implants include breast implants, biodegradable
plates, metallic fasteners, rods, plates, screws, spacers, cages,
compliant bearing implants for one or more compartments of the
knee, nucleus pulposus implant, stents, meniscal implants, tissue
grafts, tissue scaffolds, biodegradable collagen scaffolds, and
polymeric or other biocompatible scaffolds.
[0317] Also, fasteners and sutures may be utilized to position bone
replacement implants including joint replacement components such as
for the knee and hip, drug delivery implants, pain pumps, spinal
implants, dental implants, tissue implants, tissue patches such as
porcine, bovine, or patches disclosed in U.S. Pat. No. 6,592,625 to
Cauthen, and other implants. The previously mentioned patent is
hereby incorporated by reference. The implants, fasteners, and
sutures may also include cells bonded to their surface. The cells
may be bonded with a biocompatible adhesive, such as those describe
herein, and/or may be bonded electromagnetically or with
vanderwalls forces. While implant anchoring is described below in
reference to intervertebral disc implants, it should be understood
that the methods described herein may be used for anchoring any
implant with the body.
[0318] In FIG. 24, a prosthetic disc implant 730 is positioned
between two vertebrae (only one shown) 684. The annulus fibrosis
688 encircles the implant 730. A fastener 630V is placed within the
posterior portion of the annulus 688. A suture 700J loops around
and/or through the implant 730, and the suture 700J is secured with
the fastener 630V. Tensioning the suture 700J in this configuration
stabilizes the implant 730 by preventing movement of the implant
730 in a posterior-anterior direction. Two other fasteners 630W,
630X are positioned against the annulus 688 generally on the sides
of the annulus. A suture 700K connects these two fasteners 630W,
630X and holds the implant 730 preventing movement in a
side-to-side or lateral direction. It is contemplated that the
sutures and fasteners used to anchor an implant may extend through
or around the implant.
[0319] FIG. 25 illustrates a disc implant 730 stabilized between a
superior vertebra 682 and inferior vertebra 684. A fastener 630Y is
positioned within the implant 730 while another fastener 630Z is
placed within or against the superior vertebra 682. A suture 700L
is tensioned between the fasteners 630 to hold the implant 730 to
the lower surface of the superior vertebra 682. For added
stability, a fastener 630AA is placed within or against the
inferior vertebra 684 while another fastener 630AB is positioned
against the implant 730. A suture 700M passes through the implant
730 and the fasteners 630AA, 630AB, and the ends of the suture 700M
are secured. Any of the methods and devices described herein or
incorporated by reference may be used to fasten the ends of the
suture.
[0320] As previously mentioned, the implant may be any object
surgically placed within the body. The implant may be made from
various biocompatible materials. Also, the implant may be
expandable within the body. A hydrophilic implant may swell or
expand by absorbing liquid. A resilient implant may be compressed
prior to implantation, then expand once positioned within the body.
It is contemplated that an expandable implant may be stabilized
using any method and device disclosed herein. In addition, the
expandable implant may be held with fasteners and sutures such that
expansion of the implant may be directed in a preferred direction
or directions. Moreover, electromagnetic pulsed energy may be used
to thermally lock a suture to the implant within the body.
[0321] In FIG. 26, an implant 730 is stabilized to a vertebra 684
with multiple sutures and fasteners in a way to allow the implant
to expand anteriorly. A first fastener 630AC is positioned against
the left side of the annulus 688, while a second fastener 630AD is
placed within or against the right side of the implant 730. A
suture 700N extends between the first and second fasteners 630AC,
630AD. When tensioned, the suture 700N prevents the implant 730
from expanding to the right while holding the top of the implant
730 as well. A third fastener 630AE is positioned against the right
side of the annulus 688. A suture 700O is looped around and/or
through the implant 730 and secured with the third fastener 630AE
to thereby prevent the implant 730 from expanding to the left. A
fifth fastener 630AF is positioned against the anterior side of the
annulus 688, while a sixth fastener 630AG is place within or
against the posterior side of the implant 730. A suture 700P
positioned between the fifth and sixth fasteners 630AF, 630AG keeps
the implant 730 from expanding in the posterior direction. Given
this configuration of sutures and fasteners, the implant 730 is
limited to expansion in only the anterior direction. It is
contemplated that other configurations of sutures and fasteners may
be used to limit the expansion of the implant to one or more
directions. That is, the implant may be allowed to expand to the
left, right, posterior, anterior, up, down, diagonally, or any
combination thereof.
[0322] The present invention also provides an enclosure 740 for
stabilizing and anchoring an implant and furthermore to direct
expansion of the implant in zero, one, or more desired directions.
FIG. 27A illustrates an enclosure (or pouch, bag, sac, etc) 740a
for an implant. The implant may be expandable or non-expandable.
The pouch 740 may include one or more anchoring points 742. The
anchoring points 742 may be placed on any of the corners, edges, or
other surfaces so that when anchored the pouch 740 is properly
secured at the desired location and orientation. A flap or lid 744
allows access into the pouch 740 for positioning of the implant.
The flap 744 may be closed and sealed so the entire implant is
enclosed. A pouch that completely encloses an expandable implant
would allow the implant to expand omni-directionally until
restricted by the pouch. The lip or flap may be resealable such
that the material may be added to or removed from the pouch inside
the body.
[0323] The pouch may be made from any natural or artificial
material. For example, it may be formed from material which is
polymeric, composite, metallic, ceramic, or combinations thereof.
Furthermore, the pouch may be made of or include body tissue
including bone, collagen, cartilage, muscle, tendon, ligaments, or
other tissue graft material. The material of the pouch may be
solid, porous, bioabsorbable, bioerodible, degradable, and/or
biodegradable. The pouch may be made from a porous matrix or mesh
of biocompatible and/or bioabsorbable fibers or filaments acting as
a scaffold to regenerate tissue. The fibers or filaments may be
interlaced, braided, or knitted to form the pouch.
[0324] The pouch may include or may be filled with therapeutic
substances or drugs, like antibiotics, hydroxypatite,
anti-inflammatory agents, steroids, antibiotics, analgesic agents,
chemotherapeutic agents, bone morphogenetic protein, demineralized
bone matrix, collagen, growth factors, autogenetic bone marrow,
progenitor cells, calcium sulfate, immo suppressants, fibrin,
osteoinductive materials, apatite compositions, fetal cells, stem
cells, enzymes, proteins, hormones, and germicides. The pouch may
further include or be filled with a gelatin which may contain a
therapeutic agent. The gelatin inside the pouch may slowly
osmotically leak out into the surrounding tissue.
[0325] The pouch may also include an adhesive to bond the pouch to
the implant, to bond the pouch to the implantation site, and/or
bond the flap to the pouch. Such adhesives may include
cyanoacrylate adhesives, hydrogel adhesives, monomer and polymer
adhesives, fibrin, polysaccharide, Indermil.RTM. or any other
biocompatible adhesive. A pouch filled with one or more therapeutic
agents may form a drug cocktail implant. The therapeutic agents
selected to be inserted within the pouch may be specifically
tailored to the needs of the patient. The pouch may be filled
outside or within the patient. Once placed within the body, the
therapeutic agent may slowly dissolve and exit the pouch through an
osmotic member to reach the surrounding tissue.
[0326] In another exemplary embodiment, FIG. 27B shows a pouch 740b
with a bi-directional expansion ports 746 on the left and right
sides. When an expandable implant is placed in the pouch 740 and
secured at the implantation site, the implant is restricted in
expansion in all directions except to the left and right. It is
contemplated that the pouch 740 may be designed with one or more
expansion ports 746 facing in any direction. In FIG. 27C, the pouch
740c includes a unidirectional expansion port 748. The pouch 740
allows the expandable implant to expand upward. A pouch with an
upward or downward pointing expansion port may be particularly
useful for prosthetic disc replacement. Once placed in the pouch
and positioned between two vertebrae, an expandable implant may
expand to increase the space between the vertebrae.
Example 4
Ligament Repair
[0327] Instability of joints between bones has long been the cause
of disability and functional limitation in patients. Joints of the
musculoskeletal system have varying degrees of intrinsic stability
based on joint geometry and ligament and soft tissue investment.
Ligaments are soft tissue condensations in or around the joint that
reinforce and hold the joint together while also controlling and
restricting various movements of the joints. When a joint becomes
unstable, either through disease or traumatic injury, its soft
tissue or bony structures allow for excessive motion of the joint
surfaces relative to each other and in directions not normally
permitted by the ligaments.
[0328] Common problems associated with excessive joint motion are
malalignment problems, subluxation of the joint, and possibly joint
dislocation. Typically, the more motion a joint normally
demonstrates, the more inherently loose is the soft tissue
surrounding the joint. A loose ligament or group of ligaments
ultimately causes skeletal disorders. However, over tensioning
ligaments restricts motion of the joint and can also cause
musculoskeletal problems.
[0329] The present invention also provides methods of tensioning a
ligament (or tendon) or group of ligaments (or tendons) during a
surgical procedure and "on the way out" after the surgical
procedure to prevent joint instability and reduce pain. These
methods can be applied to any ligament in the body, including the
ligaments of the knee (like the anterior cruciate ligament and
iliotibial band), shoulder, elbow, wrist, hip, ankle, hands, and
feet. For illustrative purposes, the methods of the present
invention are described with reference to the spine.
[0330] When an intervertebral disc becomes herniated and loses
nucleus pulposus tissue, the distance between the adjacent
vertebrae is reduced from the compression of the annulus and
remaining nucleus pulposus. As a result, the spine ligaments may
become relaxed. These ligaments may include, but are not limited
to, the anterior longitudinal ligament, posterior longitudinal
ligament, interspinous ligaments, supraspinous ligament, ligamentum
flavum, intertransverse ligament, facet capsulary ligament,
ligamentum nuchae, and ligaments of the sacrum and coccyx
spine.
[0331] FIG. 28 shows an anterior longitudinal ligament 750 which
has become weakened. The fasteners and sutures of the present
invention may be used to tighten the anterior longitudinal ligament
750 and decrease anteroposterior translation of the adjacent
intervertebral discs. It should be understood that the methods
described with respect to the anterior longitudinal ligament may
also be applied to tightening other ligaments of the body.
[0332] A fastener 630AH is positioned against the ligament 750
adjacent the upper end of a loosened region 752 of the ligament
750. Another fastener 630AI is positioned against the ligament 750
adjacent the lower end of the loosened region 752. A suture 700Q is
positioned through the ligament 750 and through the fasteners
630AH, 630AI. The suture 700Q is tensioned thereby tightening the
loosened region 752 of the ligament 750.
[0333] In another embodiment, a fastener 630AJ is positioned
against the ligament 750 above a stretched region 754. Another
fastener 630AK is placed against the ligament 750 below the
stretched region 754. A suture 700R is placed through the ligament
750, adjacent vertebrae 756 and 758, and intervertebral disc 680 in
a curved or looped configuration. The suture 700R is tensioned to
tighten the stretched region 754.
[0334] In a further embodiment represented in FIG. 28, one fastener
630AL is positioned against the ligament 750 above a missing or
torn ligament region 760. Another fastener 630AM is positioned
against the ligament 750 below the missing region 760. The suture
700S is positioned through the superior and inferior ends of the
ligament 750 at the missing or torn region 760. The suture 700S is
tensioned between the fasteners 630AL, 630AM causing the ends of
the ligament 750 to be drawn together.
[0335] To stabilize the spine while a loosened or torn ligament
heals, a stabilization implant, such as a rod or plate 762, may be
positioned adjacent spinous processes 764. The fasteners and
sutures of the present invention may be used to secure the rod or
plate 762 to the spine. A plurality of fasteners 630AN is
positioned against the rod or plate 762 proximate to each spinous
process 764. A second plurality of fasteners 630AO is placed within
or against the spinous processes 764. Sutures 700T extend between
the fasteners 630AN, 630AO and are tensioned. Once anchored, the
rod or plate 762 limits movement of the spinous processes 764
relative to each other thereby limiting movement of the anterior
longitudinal ligament 750.
[0336] It is contemplated that the fasteners of the present
invention be placed within or adjacent any bone of the body. When
used in the knee, for example, the fasteners may be placed adjacent
the femur, tibia, or patella. Within the spine, an fastener may be
positioned adjacent a posterior arch, a spinous process, a lateral
or medial articular process, a pedicle, odontoid process, uncinate
process, a posterior tubercle, carotid tubercle, or a vertebral
body.
Example 5
Ligament Reconstruction
[0337] The present invention may also be used in ligament or tendon
reconstruction. Ligaments are frequently damaged, detached, torn,
or ruptured as the result of injury or surgery. A damaged ligament
can impede proper motion of a joint and cause pain. Therefore,
during or "on the way out" from a surgical procedure, a ligament
may be reconstructed using a fastener, a tissue graft, and/or a
tissue scaffold with or without cells.
[0338] The devices and methods of the present invention may be used
with a tissue or artificial graft to tension and stabilize the
damaged ligament. Any ligament of the body may be repaired using
the present invention, including the ligaments of the spine,
shoulder, elbow, hip, knee, ankle, feet, and hands. The present
invention is described in reference to ligaments of the spine
including the anterior and posterior longitudinal ligaments,
interspinous ligaments, supraspinous ligaments, superior
costotransverse ligaments, ligamentum flavum, facet capsulary
ligament, intertransverse ligament, ligamentum nuchae, and
ligaments of the sacrum and coccyx spine.
[0339] In an exemplary embodiment, FIG. 29 shows a damaged anterior
longitudinal ligament 750. A ligament graft 770 is positioned
adjacent the damaged region 772. A first fastener 630AP is placed
against the inferior end of the ligament graft 770, while a second
fastener 630AQ is positioned within or against a vertebral body
774. A suture 700U extends through the graft 770, ligament 750, and
vertebra 774. The suture 700U is tensioned, and the ends of the
suture 700U are secured. Similarly, two fasteners 630AR, 630AS and
a suture 700V are positioned at the superior end of the ligament
graft. To further anchor the ligament graft 770 to the anterior
longitudinal ligament 750, one fastener 630AT is positioned against
the graft 770 on one side of the damaged region 772, and another
fastener 630AU is placed against the graft 770 on the other side of
the damaged region 772. A suture 700W is placed through the graft
770, ligament 750, adjacent vertebrae 682 and 684, and
intervertebral disc 680 in a generally curved, looped, or C
configuration. The suture 700W is tensioned, and the ends of the
suture 700W secured. It is also contemplated that the curved or
looped suture may be placed through multiple intervertebral discs
and vertebrae.
[0340] In another embodiment, FIG. 29 shows a graft 770 positioned
between two adjacent vertebrae 682 and 684. The ligament or bone
graft 770 is positioned adjacent the damaged region 772 of the
anterior longitudinal ligament 750. The graft 770 may be attached
using any of the devices and methods described herein and
incorporated by reference. In an exemplary embodiment, two
fasteners 630AV, 630AW are placed at the superior and inferior ends
of the graft 770. Two other fasteners (not shown) are positioned
within or against each vertebra 682 and 684. Sutures are positioned
between the fasteners and tensioned.
[0341] To stabilize the longitudinal ligament 750 while the damaged
region 772 heals, sutures and fasteners may be placed on the
posterior side of the spine for stabilization. One fastener 630AX
is placed within or against a spinous process 764, while another
fastener 630AY is positioned within or against a pedicle or bone of
the facet joint 776. A suture 700X extends between the fasteners
630AX, 630AY thereby limiting movement of the spine. FIG. 29 shows
an additional stabilization device between an upper and lower
spinous process. In this configuration, the suture and fasteners
provide additional restriction to the movement of the spine.
[0342] The ligament or bone graft may be obtained from a variety of
sources and/or made from various materials. In an exemplary
embodiment, the ligament graft is made of collagen. The graft could
also include autograft, allograft, or xenograft material. The graft
may be a tendon graft, bone-tendon-bone graft, or a meniscus graft.
Other material which may be used in the formation of the graft is
polymer, carbon fiber, PEEK, PTFE, a biodegradable material,
elastic or flexible material, Gore-Tex.RTM., or woven fiber. The
ligament graft may include therapeutic substances. These include
antibiotics, hydroxypatite, anti-inflammatory agents, steroids,
antibiotics, analgesic agents, chemotherapeutic agents, bone
morphogenetic protein, demineralized bone matrix, collagen, growth
factors, autogenetic bone marrow, progenitor cells, calcium
sulfate, immo suppressants, fibrin, osteoinductive materials,
apatite compositions, fetal cells, stem cells, enzymes, proteins,
hormones, and germicides.
[0343] Use of grafts or patches to repair, reconstruct, and augment
tissue, like a ligament, may include patches such as
TissueMend.RTM. patches, Restore.RTM. patches, or similar
products.
Example 6
Ligament Augmentation
[0344] In addition to ligament repair and reconstruction, the
devices and methods of the present invention may be used for
ligament or tendon augmentation. Ligament augmentation reinforces
or supplements natural ligaments. A ligament may be augmented or
reinforced after it has been repaired or reconstructed. Also, a
non-repaired ligament may be augmented prophylactically. In this
case, the augmentation may be used to increase the load-bearing
capacity of the ligament or tendon. Additionally, or alternatively,
the augmentation may be used to prevent a potential injury to a
ligament or tendon. For example, an athlete may undergo minimally
invasive surgery to reinforce a ligament or tendon so as to prevent
the ligament or tendon from being injured later in the athlete's
career. Many talented athletes' careers are cut short because of
any injury to a body joint, like the knee, shoulder, ankle, spine,
wrist, or hip. If an athlete desired to prevent or at least reduce
the chance of sustaining a career ending injury, he/she could have
surgery to augment or "fail-safe" a joint and its ligaments and
tendons even if there are no other risk factors other than the
occupation. Of course, other risk factors, such as genetic
predisposition, could be considered, if desired.
[0345] The devices and techniques described herein relate to
augmenting any ligament or tendon of the body including ligaments
of the knee, shoulder, spine, hand, foot, hip, and elbow. For
illustrative purposes only, ligament augmentation is described with
reference to the anterior cruciate ligament (ACL) of the knee. It
should be understood that the description of augmentation to the
knee is not limiting to other ligaments and tendons.
[0346] In an exemplary embodiment, fasteners and a suture (or
similar device like a cable, band, flexible moment arm, pin, rod,
or K-wire) may be used to augment a ligament. Referring to FIGS.
30A, 30B, and 30C, a fastener 630 may be positioned near one end of
the ligament 780, while another fastener 630 may be placed near the
opposite end of the ligament 780. The suture or cable 700 may be
placed between the fasteners 630 and may be generally parallel with
the ligament 780. The suture 700 may be tensioned, and the ends of
the suture 700 secured with the fasteners 630. It is contemplated
that multiple fasteners and multiple sutures may be utilized to
augment the ligament. For example, a suture 700 may be placed at an
angle to the ligament 780 with the ends of the suture 700 secured
with fasteners 630. Having multiple sutures at different angles
relative to each other and/or the ligament may provide
multiple-direction augmentation.
[0347] In a further exemplary embodiment, a tissue graft or
scaffold (reinforcement means) 782 may be used to augment the
ligament or tendon 780. The graft or scaffold 782 may be configured
and include materials as described herein. The graft or scaffold
782 may be positioned generally parallel to the ligament 180
requiring augmentation. The ends of the graft 782 may be anchored
to bone, ligament, or other tissue using the devices and methods of
the present invention. For example, one fastener may be positioned
in or against the graft while another fastener may be placed in or
against adjacent tissue. A suture may be tensioned between the
fasteners, and the ends of the suture secured with the fasteners.
Also, a fastener 630 may be positioned against the graft or
adjacent tissue, and a suture 700 may be wrapped around the
adjacent tissue and graft one or multiple times to form a band or
latching. The suture 700 may be tensioned and secured with the
fastener 630. It is contemplated that multiple grafts and/or
scaffolds may be used to augment the ligament or tendon. For
example, grafts or scaffolds may be at different angles to the
ligament to provide augmentation in multiple directions.
[0348] Furthermore, it is contemplated that the graft or scaffold
782 used to augment the ligament or tendon may be secured to tissue
using a band-like device 784. The band 784 may be wrapped around
the graft or scaffold 782 and adjacent tissue, like a bone 786. The
band 784 may be a biocompatible elastic band, a tissue graft, a
polymeric or metallic tie (like a wire tie), or other suitable
banding apparatus.
[0349] The suture and/or graft (reinforcement means) 782 used to
augment the ligament or tendon may be placed parallel or diagonal
to the ligament or tendon. Also, the suture and/or graft may be
helically or spirally wrapped around the ligament or tendon. The
ligament or tendon may be helically or spirally wrapped around the
suture or graft. The reinforcement means may be positioned within
or interwoven, braided, or weaved into the ligament or tendon.
[0350] As previously described, an athlete may desire to undergo
elective surgery to "fail safe" a joint and/or ligaments. A
football player, for example, who is at high risk for a knee injury
may choose to augment or reinforce the anterior cruciate ligament
850, posterior cruciate ligament 852, tibial collateral ligament
854, fibular collateral ligament 856, posterior meniscofemoral
ligament 858, and/or transverse ligament 860. The suture, cable,
and/or graft used to reinforce the ligament may be tensioned and
positioned such that the natural ligament is exclusively used
during normal athletic activities. However, when the joint (knee)
is extended or dislocated beyond its normal range of motion, the
reinforcement means (suture, cable, graft, flexible rod, etc.)
engages to stop the extension or dislocation thereby preventing
injury to the joint. The engagement of the reinforcement means may
provide a sudden stopping action when the joint or ligament is
about to reach or has reached an abnormal position. Alternatively
or additionally, the engagement of the reinforcement means may
provide a gradual stopped action (e.g. stretching/elastic) as the
joint/ligament approaches its maximum normal range.
[0351] The reinforcement means 782 may be implanted between bones,
ligaments, and/or tendons. When the ACL is to be augmented or
reinforced, the reinforcement means may extend between the femur
862, tibia 864, and/or fibula 865, may extend from the superior end
of the ligament to the tibia and/or fibula, may extend from the
inferior end of the ligament to the femur, and/or may extend
between the superior and inferior ends of the ligament itself. The
reinforcement means may be positioned parallel or at an angle to
the ligament. The means may be a tubular sheath 866 that
encapsulates the ligament, like a sheath on a wire or a braided
sheath 868 on a fuel or hydraulic line. The sheath (reinforcement
means) would function as previously described, i.e. provide gradual
and/or sudden stopping action to the joint/ligament.
[0352] It is contemplated that augmentation or reinforcement of
ligaments and tendons of a joint for athletes or other patients be
performed using minimally invasive techniques. In the case of an
athlete undergoing reinforcement or "fail safe" surgery, the
surgeon must produce a minimum amount of dislocation and resection
of soft tissue in order to minimize recovery time. Furthermore,
physicians could take into consideration the natural growing rate
of the athlete/patient. As the athlete grows and/or gains size and
weight from physical workouts, the length, strength, and size of
joints/ligaments/tendons may change. To account for this, the
reinforcement means may be modifiable using a small portal in soft
tissue to access the means in the joint. Once accessed, an
extension 870 may be added to the reinforcement means.
Alternatively, the reinforcement means may include three portions.
The two end portions 872 may be fastened in tissue while the middle
portion 874 resides between the end portions. The middle portion
874 may be disconnected from the end portions 872 and replaced with
a different middle portion 874 having a different length, strength,
and/or size. In this configuration, the end portions are not
removed from the tissue therefore there is no healing time required
for the end portions to secure to tissue.
Example 7
Laminectomy
[0353] A laminectomy is a surgical procedure which is designed to
relieve pressure on the spinal cord or nerve root that is being
caused by a slipped or herniated disk in the lumbar spine. A
laminectomy removes a portion of bone over the nerve root or disc
material from under the nerve root to give the nerve root more
space and a better healing environment. Also, a laminectomy is
effective to decrease pain and improve function for a patient with
lumbar spinal stenosis. Spinal stenosis is caused by degenerative
changes that result in enlargement of the facet joints. The
enlarged joints place pressure on the nerves. During a laminectomy,
there is much muscle stripping and ligament tearing. The back
muscles or erector spinae are dissected off the lamina on both
sides and at multiple levels. The facet joints, directly over the
nerve roots, are cut to give the nerve roots space. Usually, once
the nerve roots are provided with more room, the operation is
completed by closing the skin incision. The methods and devices of
the present invention may be used to repair, reconstruct, augment,
and stabilize tissue or an implant "on the way out" of the pathway
created in the soft tissue to access the nerve roots. Muscle may be
reattached to muscle; ligaments may be repaired or reconstructed;
tissue grafts may be implanted; bones may be stabilized; and
implants may be inserted.
[0354] Referring to FIG. 31, a laminectomy site is illustrated. A
portion of the ligamentum flavum 790 is dissected and removed
between two spinous processes 706 and 708. The distal end of the
lamina 792 is removed from the superior spinous process 706. The
laminectomy site and surrounding tissue is repaired, reconstructed,
or augmented to compress and stabilize the tissue for enhanced
healing. Fasteners 630BA and sutures or cables 700Y are placed in
the adjacent vertebral bodies 682 and 684 to provide flexible
fixation of the spinal joint and limit the range of motion of the
spine. A fastener 630BB is positioned on the posterior side of the
ligamentum flavum 790 above the laminectomy site. Another fastener
630BC is positioned on the posterior side of ligamentum flavum 790
below the operation site. A suture 700Z is placed between the
fasteners 630BB, 630BC. The suture 700Z is tensioned and secured
with the fasteners 630BB, 630BC to provide flexible fixation of the
ligamentum flavum 790.
[0355] Another fixation device is placed between the inferior and
superior spinous processes. A fastener 630BD may be positioned
against one of the spinous processes 764, and a suture 700AA may be
wrapped between two spinous processes 706, 708. The suture 700AA
may be tensioned, and the ends of the suture 700SS may be secured
with the fastener 630BD. This configuration provides further
flexible stabilization of the spinal column near the laminectomy
site. Finally, a ligament graft or scaffold 782 may be positioned
along the ligamentum flavum 790 over the laminectomy site. The
graft 782 may reconnect and stabilize the ligamentum flavum 790. It
should be understood that additional fasteners may be used to
compress and stabilize surrounding tissue.
Example 8
Joint Stabilization
[0356] Following surgery within the body, especially surgery of a
joint, the soft tissue around and near the joint may become
weakened, and the range of motion of the joint usually increases
thereby allowing excessive tissue laxity. Also, instability of a
joint may be caused by structural changes within the joint as a
result of trauma, degeneration, aging, disease, surgery, or a
combinations thereof. An unstable joint may be fused to form a
permanent or rigid internal fixation of all or part of the joint.
Alternatively, joints may be stabilized with the devices and
methods of the present invention, without fusion. In an exemplary
embodiment, tissue may be repaired, reconstructed, augmented, and
stabilized during and "on the way out" of a surgical procedure such
as those surgical procedures described herein. Compressing and
stabilizing the tissue around a joint enhances tissue healing.
Using flexible fixation, the tissue may be secured but still allow
for some range of motion of the joint. Where flexible fixation is
not desired, the devices and methods of the present invention may
be used for rigid fixation, such as for bones.
[0357] As a further example, fasteners and sutures could be used to
stabilize the knee joint. The sutures could be positioned between
at least two of the femur, tibia, patella, and adjacent ligaments
to stabilize the knee without significantly restricting the knee's
normal range of motion. Moreover, the devices and methods may be
used to stabilize any joint of the body, including the spine,
shoulder, elbow, wrist, hip, knee, ankle, and joints of the hands
and feet. Additionally, the present invention may be used with a
temporal mandibular joint, SI joint, facet joint, temporomandibular
joint, and sacroiliac joint.
[0358] For illustrative purposes, the present invention is
described in greater detail with respect to the spine. FIG. 32
shows a posterior view of the head and cervical spine with three
vertebrae: C1 (Atlas), C2 (Axis), and C3. The cervical spine and
head are stabilized using diagonally positioned sutures. Fasteners
630BE, 630BF are positioned within or against the left and right
side of the occipital bone 800 of the head. Two other fasteners
630BG, 630BH are placed within or against the left and right sides
of the posterior arch of the C1 vertebra 802. A suture 700AB
extends between the left fasteners 630BE, 630BG, while another
suture 700AC extends between the right fasteners 630BF, 630BH. When
tensioned, the sutures 700AB, 700AC limit movement of the head
relative to the cervical spine.
[0359] FIG. 32 also shows tissue graft 804, such as a ligament
and/or bone graft, positioned between a vertebra 806 and the head
808. The grafts 804 may be attached using any of the devices and
methods described herein and incorporated by reference. In an
exemplary embodiment, fasteners 630BI are placed at the superior
and inferior ends of the graft. Other fasteners (not shown) are
positioned within or adjacent the bone. Sutures extend between the
fasteners and are tensioned.
[0360] Further stabilization of the cervical spine may be obtained
by placing sutures and fasteners lower in the cervical spine. In an
exemplary embodiment, a crisscross pattern of sutures is placed
between two adjacent vertebrae. The upper fasteners 630BJ may be
placed within or against the superior vertebra 682, while the lower
fasteners 630BK may be positioned within or against the inferior
vertebra 684. Sutures 700AD extend between the fasteners, and when
tensioned, the sutures 700AD stabilize the vertebrae 682 and 684
from movement between one another.
[0361] In another embodiment as shown in FIG. 33, a vertebra 814
has been decompressed using fasteners and a suture. A first
fastener 630BL is placed within or adjacent an upper vertebra 812,
and a second fastener 630BM is positioned within or adjacent a
lower vertebra 816. A suture 700AE is positioned through the left
side of the vertebrae 812, 814, and 816 in a curved, looped, or C
configuration. The suture 700AE is tensioned, and the ends of the
suture 700AE secured. By tensioning the suture 700AE, the right
side of the middle vertebra 814 becomes decompressed.
[0362] In another exemplary embodiment, multiple vertebrae may be
decompressed by positioning fasteners 630BN, 630BO on two vertebrae
810 and 818 which are separated by two or more vertebrae. A tubular
member or sleeve 652 is positioned between the fasteners 630BN,
630BO and through the vertebrae in between. A suture 700AF is
placed within the sleeve 652, tensioned, and secured with the
fasteners 630BN, 630BO. Moreover, the fasteners 630BN, 630BO may be
placed on any part/portion of the vertebrae 810 and 818, as
described previously, so when the suture is tensioned, one or more
vertebrae are decompressed, forming a decompressed region 824.
[0363] As further seen in FIG. 33, the spine has been stabilized
using the pedicles of the spine. A fastener 630BP is placed within
or adjacent a pedicle 820. A second fastener 630BQ is placed within
or adjacent another pedicle 822. A suture 700AG extends between the
fasteners 630BP, 630BQ either through the pedicles or outside the
pedicles. The suture 700AG is tensioned and the ends of the suture
secured.
[0364] While FIG. 33 illustrated a suture positioned between two
pedicles, it is contemplated that the suture may be affixed to any
portion/part of the vertebrae. For example, a suture may be
tensioned between any one or more of the following: transverse
process, pedicles, facets, spinous process, posterior arch,
odontoid process, posterior tubercle, lateral articular process,
uncinate process, anterior tubercle, carotid tubercle, and
vertebral body.
[0365] The suture, or similar device like a cable, band, flexible
moment arm, pin, rod, or K-wire, is made of a material having
sufficient strength and fatigue characteristics. The suture may be
biodegradable and/or flexible. It may include metallic material,
ceramic material, polymeric material, composite material, or
combinations thereof. In one embodiment, the suture is formed of
fiber material like carbon or polyamide fibers. Sutures may also be
formed from Mersilene.RTM., polypropylene braided or collagen
strips, allograft or xenograft strips, braided mesh, a polymer,
PTFE, or Gore-Tex.RTM.. The suture may be made of or include an
elastic, flexible material which stabilizes the skeletal and
ligamentous system but allows some movement of the joints. Also,
the suture may be barbed or could be a threaded wiring device.
[0366] The disclosed methods for spine stabilization described thus
far included positioning fasteners against bone or an implant.
However, the present invention also contemplates stabilizing a
joint of the body by affixing a suture between ligaments, tendons,
bones, cartilage, tissue grafts or combinations thereof. For
example, a suture may be positioned between a vertebra and a
longitudinal ligament, between a spinous process and the
supraspinous ligament, or between a facet and a facet capsulary
ligament. Any combination of attachment points is contemplated to
stabilize the joint.
[0367] Furthermore, any of the methods described herein could
utilize a plurality of sutures and more than two fasteners. The use
of multiple sutures can vary the tension or resistance between the
fasteners securing the suture, thereby providing various levels of
stability. The use of multiple fasteners, preferably spaced apart
and positioned adjacent the region of the joint to be stabilized,
could provide various angles of stabilization.
[0368] It is further contemplated that by using multiple sutures
and fasteners at different locations of the spine, ligaments and
bones of the spine may be selectively tightened or stabilized to
provide a customized environment for spine healing. For example,
the sutures may be tightened sequentially between the fasteners, or
the entire construct could be tightened down together.
Related Techniques
[0369] It is contemplated that the devices and methods of the
present invention be applied using minimally invasive incisions and
techniques to preserve muscles, tendons, ligaments, bones, nerves,
and blood vessels. A small incision(s) may be made adjacent the
damaged tissue area to be repaired, and a tube, delivery catheter,
sheath, cannula, or expandable cannula may be used to perform the
methods of the present invention. U.S. Pat. No. 5,320,611 entitled,
Expandable Cannula Having Longitudinal Wire and Method of Use,
discloses cannulas for surgical and medical use expandable along
their entire lengths. The cannulas are inserted through tissue when
in an unexpanded condition and with a small diameter. The cannulas
are then expanded radially outwardly to give a full-size instrument
passage. Expansion of the cannulas occurs against the viscoelastic
resistance of the surrounding tissue. The expandable cannulas do
not require a full depth incision, or at most require only a
needle-size entrance opening.
[0370] Also, U.S. Pat. Nos. 5,674,240; 5,961,499; and 6,338,730
disclose cannulas for surgical and medical use expandable along
their entire lengths. The cannula has a pointed end portion and
includes wires having cores which are enclosed by jackets. The
jackets are integrally formed as one piece with a sheath of the
cannula. The cannula may be expanded by inserting members or by
fluid pressure. The cannula is advantageously utilized to expand a
vessel, such as a blood vessel. An expandable chamber may be
provided at the distal end of the cannula. The above mentioned
patents are hereby incorporated by reference.
[0371] In addition to using a cannula with the methods of the
present invention, an introducer may be utilized to position
fasteners at a specific location within the body. U.S. Pat. No.
5,948,002 entitled, Apparatus and Method for Use in Positioning a
Suture Anchor, discloses devices for controlling the placement
depth of a fastener. Also, U.S. Patent Application Publication No.
2003/0181800 discloses methods of securing body tissue with a
robotic mechanism. The above-mentioned patent and application are
hereby incorporated by reference. Another introducer or cannula
which may be used with the present invention is the VersaStep.RTM.
System by Tyco.RTM. Healthcare.
[0372] The present invention may also be utilized with minimally
invasive surgery techniques disclosed in U.S. Pat. Nos. 6,702,821,
6,770,078, and 7,104,996. These patent documents disclose, inter
alia, apparatus and methods for minimally invasive joint
replacement. The femoral, tibial, and/or patellar components of a
knee replacement may be fastened or locked to each other and to
adjacent tissue using fasteners disclosed herein and incorporated
by reference. Furthermore, the methods and devices of the present
invention may be utilized for repairing, reconstructing,
augmenting, and securing tissue or implants during and "on the way
out" of a knee replacement procedure. For example, the anterior
cruciate ligament and other ligaments may be repaired or
reconstructed; quadriceps mechanisms and other muscles may be
repaired. The patent documents mentioned above are hereby
incorporated by reference.
[0373] Moreover, the devices and methods of the present invention
may by used to approximate a skin incision where there may be undue
tension on the skin. Fasteners may be placed on opposite sides of
the incision, and a suture or cable may be placed between the
fasteners. When the suture is tensioned, the skin may be pulled
together and held until the skin tissue relaxes. Then, the
fasteners may be unlocked, and the suture may be tensioned again to
further approximate the skin incision. The locking and unlocking of
the fasteners along with the tensioning of the suture may be
repeated until the incision is fully closed.
[0374] Furthermore, it is contemplated that the present invention
may be used with bariatric surgery, colorectal surgery, plastic
surgery, gastroesophageal reflex disease (GERD) surgery, or for
repairing hernias. A band, mesh, or cage of synthetic material or
body tissue may be placed around an intestine or other tubular body
member. The band may seal the intestine. This method may be
performed over a balloon or bladder so that anastomosis is
maintained. The inner diameter of the tubular body part is
maintained by the balloon. The outer diameter of the body part is
then closed or wrapped with a band, mesh, or patch. The inner
diameter of the tubular body member may be narrowed or restricted
by the band. The band may be secured to the tubular body part or
surrounding tissue with the devices and methods described herein
and incorporated by reference.
[0375] In addition, intramedullary fracture fixation and comminuted
fracture fixation may be achieved with the devices and methods of
the present invention. For example, a plate or rod may be
positioned within or against the fractured bone. A fastener may be
driven across the bone and locked onto the plate, rod, or another
fastener.
[0376] It is further contemplated that the present invention may be
used in conjunction with the devices and methods disclosed in U.S.
Pat. Nos. 5,329,846 entitled, Tissue Press and System, and
5,269,785 entitled, Apparatus and Method for Tissue Removal. For
example, an implant secured within the body using the present
invention may include tissue harvested, configured, and implanted
as described in the patents. The above-mentioned patents are hereby
incorporated by reference.
[0377] Additionally, it is contemplated that the devices and
methods of the present invention may be used with heat bondable
materials as disclosed in U.S. Pat. No. 5,593,425 entitled,
Surgical Devices Assembled Using Heat Bondable Materials. For
example, the fasteners of the present invention may include heat
bondable material. The material may be deformed to secure tissue or
hold a suture or cable. The fasteners made of heat bondable
material may be mechanically crimped, plastically crimped, or may
be welded to a suture or cable with RF (Bovie devices), laser,
ultrasound, electromagnet, ultraviolet, infrared,
electro-shockwave, or other known energy. The welding may be
performed in an aqueous, dry, or moist environment. The welding
device may be disposable, sterilizable, single-use, and/or
battery-operated. The above-mentioned patent is hereby incorporated
by reference.
[0378] Furthermore, it is contemplated that the methods of the
present invention may be performed under indirect visualization,
such as endoscopic guidance, computer assisted navigation, magnetic
resonance imaging, CT scan, ultrasound, fluoroscopy, X-ray, or
other suitable visualization technique. The implants, fasteners,
fastener assemblies, and sutures of the present invention may
include a radiopaque material for enhancing indirect visualization.
The use of these visualization means along with minimally invasive
surgery techniques permits physicians to accurately and rapidly
repair, reconstruct, augment, and secure tissue or an implant
within the body. U.S. Pat. Nos. 5,329,924; 5,349,956; and 5,542,423
disclose apparatus and methods for use in medical imaging. Also,
the present invention may be performed using robotics, such as
haptic arms or similar apparatus. The above-mentioned patents are
hereby incorporated by reference.
[0379] Moreover, the fasteners and methods of the present invention
may be used for the repair and reconstruction of a tubular pathway
like a blood vessel, intestine, urinary tract, esophagus, or other
similar body parts. For example, a blood vessel may be
intentionally severed during a surgical operation, or the blood
vessel may be damaged or torn as a result of an injury. Flexible
fixation of the vessel would permit the vessel to function properly
and also compress and stabilize the vessel for enhanced healing. To
facilitate the repair or reconstruction of a body lumen, a balloon
may be inserted into the lumen and expanded so the damaged,
severed, or torn portion of the vessel is positioned against the
outer surface of the inflated balloon. In this configuration, the
fasteners and methods described and incorporated herein may be used
to approximate the damaged portion of the vessel.
[0380] The guidance and positioning device of the present invention
may be used to stabilize or fasten various implants and tissues.
For example, the spine may be repaired or stabilized with
fasteners, sutures, and cables to provide flexible or rigid
reinforcement of the joints of the spine. Also, the nucleus
pulposus of an intervertebral disc may be repaired or replaced
using the guidance and positioning device of the present invention.
For example, a prosthetic disc nucleus is positioned between two
vertebral bodies and may be secured to surrounding tissue with
fasteners and sutures. Additionally, the annulus may be repaired
following a nucleus pulposus repair or replacement. The positioning
device of the present invention may be used to position a fastener
and suture on the internal side of the annulus. The suture may be
pulled proximally through the annulus, tensioned, and secured with
another fastener. Finally, the tissue alignment sleeves disclosed
in the provisional application may be guided and positioned with
the instrument and methods of the present invention. The above
mentioned provisional application is incorporated herein by
reference.
[0381] It is contemplated that the present invention may be
utilized with the tracheal tube positioning apparatus of U.S. Pat.
No. 6,820,614, entitled "Tracheal Intubation," by Peter M. Bonutti.
That patent discloses positioning apparatus located relative to a
patient's trachea by engaging the patient's trachea. Indicia on
relatively movable sections of the positioning apparatus provide an
indication of the distance between the patient's mouth and the
patient's larynx. A flexible guide rod is moved through a distance
corresponding to the distance between the patient's mouth and
larynx, as determined by the positioning apparatus. A magnet is
utilized to attract a leading end portion of the guide rod. A
plurality of emitters may be disposed in an array around the
patient's trachea. Outputs from the emitters are detected by a
detector connected with the tracheal tube. The above mentioned
patent is hereby incorporated by reference.
[0382] Drill/Sleeve Combination
[0383] In another embodiment of the present invention, a drill bit
and sleeve combination 100 is provided. In the following
description, the drill bit and sleeve combination or system 100 is
explained with reference to the fixation of two bones, like two
portions of a fractured bone. It should be understood that the
present embodiment may be utilized for fastening or securing tissue
to tissue, an implant to tissue, or an implant to an implant.
[0384] In FIG. 34 the system 100 includes a tubular member or
sleeve 102 for aligning two portions of bone located on opposite
sides of a fracture. A drill bit 104 extends through the
longitudinal lumen of the sleeve 102. The distal portion 106 of the
drill bit 104 has one or more pivoting blades 108. The system 100
may also include a pusher means 110 for inserting the sleeve 102
into the bone passage created by the drill bit 104. The pusher
means 110 may be connected to the sleeve, bit, or the drill.
Preferably, a portion of the pusher means 110 does not rotate with
the bit or drill so that the sleeve 102 is not rotated as the
pusher means 110 contacts the sleeve 102 during the drilling
operation. Examples of the pusher means 110 include a washer-shaped
member or donut-shaped member positioned over the bit or a U-shaped
fork positionable around the shaft of the bit. The lower side of
the pusher means 110 may be configured for contact with the
proximal end of the sleeve, while the upper side of the pusher
means 110 may be configured of applying a distal force with a hand,
hammer, or press.
[0385] As seen in FIG. 35, the blades 108, when extended from the
bit 104, increase the drilling diameter of the bit 104. The bone
passage created by the drill bit 104 and the extended blades 108
has a diameter generally equal to the outside diameter of the
sleeve 102. The blades 108, when retracted, pivot into or against
the distal portion 106 of the bit 104. The diameter of the drill
bit 104 with the blades 108 retracted is slightly less than the
inside diameter of the sleeve 102.
[0386] The pivoting blades 108 of the system 100 may be connected
with the distal portion 106 of the bit 104 in a variety of ways,
but preferably, the blades 108 are pivotally attached to the bit
104. In one exemplary embodiment as seen in FIGS. 34 and 21, the
blades 108 extend and retract along radial axes of the bit 104. The
blades 108 may pivot downwardly or distally into an extended
configuration and may pivot upwardly or proximally into a retracted
configuration. In the retracted state, the blades 108 may be
positioned within a groove or notch within the distal portion 106
of the bit 104. Furthermore, the blades 108 may be spring loaded to
normally reside in the retracted configuration. When the drill bit
104 is rotated with a drill, the centrifugal force generated by the
drill may cause the blades 108 to pivot into the extended
configuration. Once in the extended position, the blades 108 may be
locked into position to allow drilling or cutting of the bone.
[0387] In another exemplary embodiment, the blades 108 may be
manually pivoted distally and proximally. A pin or shaft may extend
along the center of the drill bit 104 with the distal end of the
pin in contact with the blades 108. As the pin moved
longitudinally, the blades 108 may extend and retract. The proximal
portion of the pin may include a lever or other means for moving or
advancing the pin along the center axis of the bit 104.
[0388] It is further contemplated that the blades 108 may be
extended and retracted radially in and out of the distal portion of
the bit 104 along a linear path instead of being pivoted as
previously described. In this embodiment, the blades 108 may extend
with centrifugal force and retract with a spring-like mechanism or
may be manually extended and retracted with a pin or shaft along
the central axis of the bit 104. Furthermore, other embodiments of
the blades are contemplated. For example, the blades may be
generally arch-shaped to conform to the outside circumference of
the bit. The distal ends of the blades may be pivotally attached to
the bit allowing the blades to extended radially outward for
maximum cutting diameter or retract against the outer surface of
the bit to minimize the bit diameter.
[0389] FIGS. 36 and 37 illustrate the drill bit and sleeve system
100 in use to repair a fractured bone 112. The drill bit 104 is
inserted into the lumen of the sleeve 102. The distal portion 106
of the bit 104 and the pivoting blades 108 extend beyond the distal
end of the sleeve 102. Preferably, the amount of bit 104 extending
from distal end of the sleeve 102 is minimized to prevent damage to
soft tissue of the distal side of the bone 112. The proximal
portion of the bit or shank 114 extends from the proximal end of
the sleeve 102 and is connected to a drill 116. The pivoting blades
108, located beyond the distal end of the sleeve 102, are in the
extended configuration. The bit 104 is rotated and advanced
distally through the fractured bone 112. As the bit 104 advances
and creates a passage in the bone 112, the sleeve 104 is moved
distally into the passage with the pusher means 110. The sleeve 102
is tight or snug within the passage since the diameter of the
passage is generally equal to the outside diameter of the sleeve
102. When the sleeve 102 is in its proper position securing the
bone portions 118 and 120 of the fractured bone 112, and the drill
bit 104 may be removed from the lumen of the sleeve 102. The bit
104 may be pulled from the lumen of the sleeve 102 because the
blades 108 may be positioned in the retracted configuration giving
the drill bit 104 a diameter generally smaller than the diameter of
the lumen of the sleeve 102. With the sleeve 102 in place, the bone
is compressed, and the fracture is stabilized.
[0390] In another embodiment of the present invention, the drill
bit and sleeve combination or system 100 is dimensioned and
configured for transformation into a fastener. As shown in FIGS. 38
and 39, the system 100 includes the tubular member or sleeve 102,
the pusher means 110, and a drill bit 104 with an expanding distal
portion 122. The drill bit 104 extends through the lumen of the
sleeve 102 with the distal portion 122 of the bit 104 extending
beyond the distal end of the sleeve 102. The cutting diameter of
the distal portion 122 of the bit 104 is generally equal to the
outside diameter of the sleeve 102. In this embodiment, the distal
portion 122 of the bit 104 does not include pivoting cutting
blades. However, the distal portion 122 does include means for
expansion to a diameter greater than the cutting diameter.
[0391] Some examples of expansion means are shown in FIGS. 40-42.
In FIG. 40 the expansion means includes one or more mechanically
extending barbs 126 from the distal portion 122 of the bit 104.
When extended or expanded, the barbs 126 increase the overall
diameter of the drill bit 104. The barbs 126 may extend to the
outside diameter of the sleeve 102, but preferably the barbs 126
extend beyond the outside edge of the sleeve 102. Most preferably,
the barbs 126 extend over or into the distal side of the fractured
bone 112. In the expanded configuration, the drill bit 104 is
prevented from being pulled proximally out of the sleeve 102.
[0392] In FIG. 41, the expansion means includes a distal portion
128 of the drill bit 104 which pivots. In a first orientation
during a drilling procedure, the distal portion 128 of the bit 104
is generally in-line with rest of the drill bit 104. After
drilling, the distal portion 128 of the bit 104 is rotated about a
pivot point into a second orientation. In the second orientation,
the distal portion 128 is generally perpendicular to the rest of
the drill bit 104. As a result, the end sections 132 and 134 of the
pivoted distal portion 128 of the bit 104 extend beyond the outer
diameter of the sleeve 102. Preferably, the end sections 132 and
134 extend over or into the distal side of the fractured bone 112
to prevent the bit 104 from being pulled from the sleeve 102.
[0393] In FIG. 42, the expansion means includes a distal portion
136 of the bit 104 which has two or more longitudinal sections 138
and 140 that are biased radially outward. The longitudinal sections
138 and 140 may be normally biased outward but held together by the
lumen of the sleeve 102 when drilling through the bone 112.
Alternatively, the longitudinal sections 138 and 140 may be
normally in a non-biased configuration. After the passage is
drilled in the bone 112, a plunger 142 within the drill bit 104 may
be moved distally biasing the longitudinal sections 138 and 140
radially outward. With the longitudinal sections 138 and 140
biased, the distal portion 136 of the bit 104 may extend over or
into the distal side of the fractured bone 112 to secure the bit
104 within the sleeve 102 and bone passage.
[0394] The drill bit and sleeve system 100 which transforms into a
fastener may be utilized to secure various tissue and implants.
Generally, in use, the drill bit 104 is inserted into the lumen of
the sleeve 102 with the distal portion of the bit 104 extending
beyond the distal end of the sleeve 102. The proximal portion of
the bit or shank 114 extends from the proximal end of the sleeve
102 and connects to a drill. The bit 104 is rotated and advanced
distally through the fractured bone 112. As the bit 104 advances
and creates a passage in the bone 112, the sleeve 102 is moved
distally into the passage with the pusher means 110. When the
sleeve 102 is in its proper position connecting the two portions
118 and 120 of a fractured bone 112, the shank 114 of the drill bit
104 is removed from the drill. The distal portion of the bit 104,
which extends just beyond the distal surface of the bone 112, is
expanded with the expansion means.
[0395] Once expanded, the drill bit 104 is prevented from being
pulled out of the bone passage. A retainer 144 may then be placed
around the shank 114 of the bit 104 and moved distally to engage
the proximal side of the bone 112. The retainer 144 is secured to
the shank 114. With the distal portion of the bit expanded and the
retainer connected to the shank, the drill bit (and the sleeve) is
transformed into a fastener which holds the fractured bone in
compression. It is also contemplated that the drill bit may be used
without the sleeve so that the drill bit alone becomes a
fastener.
[0396] The tubular member or sleeve of the present invention is
generally tubular shaped having a wall with an inner surface and an
outer surface. The inner surface defines a lumen which is
dimensioned and configured for receiving a drill bit, suture,
cable, K-wire, or similar device. The sleeve may include a slit
through the tubular wall. The slit allows the sleeve to be
decreased in diameter for implantation and increased in diameter
after implantation for proper alignment of the implantation site.
In a further embodiment, the sleeve may include two slits in the
tubular wall thereby forming two semi-tubular members. The
semi-tubular members may be placed separately at the implantation
site then aligned to form a complete tubular member. In another
embodiment, the tubular member is a solid member.
[0397] The tubular member or sleeve may be flexible to enable the
tubular member to be inserted into a linear or nonlinear passage
through the bone. The tubular member may be formed of metallic
material, composite material, ceramic material, polymeric material,
or combinations thereof. The sleeve may be made from a degradable,
biodegradable, bioerodible, or bioabsorbable material, such as a
polymer, composite, or ceramic. The tubular member may also include
a therapeutic substance to form a composite tubular member, or the
therapeutic substance may be coated onto the tubular member.
Furthermore, therapeutic substances or graft material (autogenic,
allogenic, xenogenic, or synthetic) may be packed into the
sleeve.
[0398] Additionally, the outer surface of the tubular member may
include a friction or gripping means. A portion of the outer
surface of the tubular member may include threads, raised pebbles,
bumps, raised ridges, or hills. In addition to a friction means on
the outer surface of the tubular member, the wall of the sleeve may
include openings for tissue ingrowth. The tubular member of the
present invention is further described in U.S. Provisional Patent
No. 60/622,095 entitled "Devices and Methods for Stabilizing Tissue
and Implants," which is hereby incorporated by reference.
[0399] Guidance and Navigation
[0400] The guidance and positioning device of the present invention
may be placed within the body of a patient with precise navigation.
For example, one or more guide wires or k-wires may be
utilized--one to hold the device in position and a second wire to
drill or pass through tissue toward the distal end of the hook of
the device. One of the guide wires or an additional wire can be
used to pull a suture or fastener through the tissue.
Alternatively, the positioning device may be positioned through an
expanding retractor with percutaneous guidance.
[0401] Other navigation techniques for precise placement of the
positioning device of the present invention include endoscopic
guidance, magnetic resonance imaging, CT scan, ultrasound,
fluoroscopy, X-ray, computer assisted navigation, magnetic
guidance, electromagnetic guidance, radiofrequency guidance,
optical guidance, and laser guidance. For example, the hook and/or
guide channel of the positioning device may include a magnet, a
radiofrequency emitter, or a thermal emitter/sensor. U.S. Pat. No.
7,104,996 entitled "Method of Performing Surgery" discloses
computer assisted navigation. In using computer assisted navigation
with the present invention, emitters, receivers, and/or reflectors
may be attached to the positioning device and/or tissue. The
computer navigation system may utilize multiple separate registers
which have optical feedback to a central unit. The computer
navigation system may utilize electromagnetic or photo-optical
feedback. U.S. Pat. Nos. 5,329,924 entitled "Sequential Imaging
Apparatus"; 5,349,956 entitled "Apparatus and Method for Use in
Medical Imaging"; and 5,542,423 entitled "Indexing Assembly for
Joint Imaging" disclose further devices and methods for use in
medical imaging. Also, the present invention may be performed using
robotics, such as haptic arms or similar apparatus. The above
mentioned patents are hereby incorporated by reference.
[0402] It is contemplated that the device and method of the present
invention be applied using minimally invasive incisions and
techniques to preserve muscles, tendons, ligaments, bones, nerves,
and blood vessels. A small incision(s) may be made adjacent the
target area to be repaired, and a tube, delivery catheter, sheath,
cannula, or expandable cannula may be used to perform the methods
of the present invention. U.S. Pat. No. 5,320,611 entitled
"Expandable Cannula Having Longitudinal Wire and Method of Use"
discloses cannulas for surgical and medical use expandable along
their entire lengths. The cannulas are inserted through tissue when
in an unexpanded condition and with a small diameter. The cannulas
are then expanded radially outwardly to give a full-size instrument
passage. Expansion of the cannulas occurs against the viscoelastic
resistance of the surrounding tissue. The expandable cannulas do
not require a full depth incision, or at most require only a
needle-size entrance opening. The above mentioned patent is hereby
incorporated by reference.
[0403] Also, U.S. Pat. Nos. 5,674,240; 5,961,499; and 6,338,730
disclose cannulas for surgical and medical use expandable along
their entire lengths. The cannula has a pointed end portion and
includes wires having cores which are enclosed by jackets. The
jackets are integrally formed as one piece with a sheath of the
cannula. The cannula may be expanded by inserting members or by
fluid pressure. The cannula is advantageously utilized to expand a
vessel, such as a blood vessel. An expandable chamber may be
provided at the distal end of the cannula. The above mentioned
patents are hereby incorporated by reference.
[0404] The present invention may also be utilized with minimally
invasive surgery techniques disclosed in U.S. Pat. Nos. 6,702,821,
6,770,078, and 7,104,996. These patent documents disclose, inter
alia, apparatus and methods for minimally invasive joint
replacement. The femoral, tibial, and/or patellar components of a
knee replacement may be fastened or locked to each other and to
adjacent tissue using fasteners disclosed herein and incorporated
by reference. Furthermore, the methods and devices of the present
invention may be utilized for repairing, reconstructing,
augmenting, and securing tissue or implants during and "on the way
out" of a knee replacement procedure. For example, the anterior
cruciate ligament and other ligaments may be repaired or
reconstructed; quadriceps mechanisms and other muscles may be
repaired. The patent documents mentioned above are hereby
incorporated by reference.
[0405] Furthermore, it is contemplated that the present invention
may be used with bariatric surgery, gastric stapling, colorectal
surgery, plastic surgery, gastroesophageal reflex disease (GERD)
surgery, ligament reconstruction surgery (such as the anterior
cruciate ligament, ACL), or for repairing hernias. A band, mesh, or
cage of synthetic material or body tissue may be placed around an
intestine or other tubular body member. The band may seal the
intestine. This method may be performed over a balloon or bladder
so that anastomosis is maintained. The inner diameter of the
tubular body part is maintained by the balloon. The outer diameter
of the body part is then closed or wrapped with a band, mesh, or
patch. The inner diameter of the tubular body member may be
narrowed or restricted by the band. The band may be secured to the
tubular body part or surrounding tissue with the device and method
of the present invention.
[0406] It is further contemplated that the present invention may be
used in conjunction with the devices and methods disclosed in U.S.
Pat. Nos. 5,329,846 entitled "Tissue Press and System" and
5,269,785 entitled "Apparatus and Method for Tissue Removal." For
example, an implant secured within the body using the present
invention may include tissue harvested, configured, and implanted
as described in the patents. The above mentioned patents are hereby
incorporated by reference.
[0407] Additionally, it is contemplated that the device and method
of the present invention may be used with heat bondable materials
as disclosed in U.S. Pat. No. 5,593,425 entitled "Surgical Devices
Assembled Using Heat Bondable Materials." For example, fasteners
may include heat bondable material. The material may be deformed to
secure tissue or hold a suture or cable. The fasteners made of heat
bondable material may be mechanically crimped, plastically crimped,
or may be welded to a suture or cable with RF (Bovie devices),
laser, ultrasound, electromagnet, ultraviolet, infrared,
electro-shockwave, or other known energy. The welding may be
performed in an aqueous, dry, or moist environment. The welding
device may be disposable, sterilizable, single-use, and/or
battery-operated. The above mentioned patent is hereby incorporated
by reference.
[0408] Moreover, the device and method of the present invention may
be used for the repair and reconstruction of a tubular pathway like
a blood vessel, intestine, urinary tract, esophagus, or similar
tubular body parts. For example, a blood vessel may be
intentionally severed during a surgical operation, or the blood
vessel may be damaged or torn as a result of an injury. Flexible
fixation of the vessel would permit the vessel to function properly
and also compress and stabilize the vessel for enhanced healing. To
facilitate the repair or reconstruction of a body lumen, a balloon
may be inserted into the lumen and expanded so the damaged,
severed, or torn portion of the vessel is positioned against the
outer surface of the inflated balloon. In this configuration, the
positioning device of the present invention may be used then to
approximate the damaged portion of the vessel.
[0409] Radiofrequency Identification
[0410] The devices, fasteners, and other apparatus disclosed herein
may include RFID (radiofrequency identification) tags. Moreover,
any surgical device, described herein or not, such as surgical
instruments, implants, trays, sponges, screws, bolts, plates,
knives, scalpels, etc. may include RFID emitting chips. RFID
provides for inventory control before, during, and after surgery.
Objects with RFID chips/tags which are located under sterile drapes
or within sterile containers may be easily located without having
to break the sterile environment. Also, surgical devices and
instruments stored in cabinets or placed in an operating room may
be scanned with an RFID receiver to help technicians and nurses
quickly identify location, type, and quantity. RFID chips/tags
placed on surgical objects may save significant time and money
during surgery and inventory. Furthermore, matching RFID chips/tags
may be placed on an instrument/device and on the tray which holds
the device. Using the RF scanner/transmitter, the correct placement
of the device can be determined. It is further contemplated that
the kits previously described may include RFID chips/tags placed on
the container and the components therein.
[0411] Surgical Tools
[0412] In another exemplary embodiment, the guidance and
positioning device of the present invention may be used with
pneumatic operated surgical instruments. For example, a gas-powered
drill may be couple with the channel guide and/or handle of the
positioning device. A surgeon may operate the drill by activating a
switch to start the fluid of gas which rotates an air motor thereby
rotating a drill bit. The drill may be connected to a compressed
gas source with tubing. However, preferably, the drill includes a
connecting port for attaching a gas cartridge or canister. Such a
drill would be free from electrical and battery power and free from
encumbering wires and hoses. The gas cartridge may be sized to fit
within the drill body or attached externally on the drill body. The
cartridge may be refillable or disposable. In addition to the drill
being gas-powered, the clamping mechanism of the positioning device
may be gas-powered. By activating the flow of gas, the clamp may be
moved to engage and compress tissue and/or an implant, holding the
tissue and/or implant in place until fasteners may be inserted. It
is further contemplated that other surgical tools, such as saws,
shavers, reamers, grinders, etc., may include gas cartridges as
previously described. These gas-powered tools may also include a
microprocessor for control and feedback.
[0413] The present disclosure includes a tissue fixation system for
dynamic and rigid fixation of tissue. The system can be utilized
for the fixation and stabilization of body tissue, including soft
tissue to soft tissue, soft tissue to bone, and bone to bone. The
surgical system can additionally be used to affix implants and
grafts to body tissue. The system can access and treat fractured,
incised or torn tissue, or the like, from one access area (i.e.,
from only one opening to the tissue to be fastened) instead of
requiring two or more openings. That is, the system is a linear
fixation system that can be used with a single, small incision or
portal in the skin or other soft tissue to gain access to the
fractured bone. The fixation system may be an all-in-one system,
packaged as a system kit, for creating a passage in tissue,
positioning fasteners, and tensioning an elongate fastening member
(e.g., a flexible line), like a suture, thread, cable, wire, rod,
or pin. The individual components of the system can either be
reusable or single use components.
[0414] Referring now to the drawing figures in which like reference
designators refer to like elements, FIG. 44 shows an exemplary
embodiment of a tissue fixation system 900 according to the present
invention. A fractured portion 902 of a bone 904 is approximated by
system 900. Use of system 900 is not limited to any particular type
of fracture. Furthermore, use of system 900 is not limited to
fracture fixation. In other words, system 900 can be utilized for
other tissue fixation applications (such as soft tissue) or similar
clinical indications. Examples of such tissue includes, are not
limited to, muscle, cartilage, ligament, tendon, skin, etc. Also,
the tissue may be stomach tissue, and the system may be used during
bariatric surgery, like stomach stapling. Additionally, the system
900 can be used for the fixation of implants to tissue.
[0415] In this regard, the present invention may be used in
conjunction with any surgical procedure of the body. The repair,
reconstruction, augmentation, and securing of tissue or an implant
may be performed in connection with surgery of a joint, bone,
muscle, ligament, tendon, cartilage, capsule, organ, skin, nerve,
vessel, or other body part. For example, tissue may be repaired,
reconstructed, augmented, and secured following intervertebral disc
surgery, knee surgery, hip surgery, organ transplant surgery,
bariatric surgery, spinal surgery, anterior cruciate ligament (ACL)
surgery, tendon-ligament surgery, rotator cuff surgery, capsule
repair surgery, fractured bone surgery, pelvic fracture surgery,
avulsion fragment surgery, hernia repair surgery, and surgery of an
intrasubstance ligament tear, annulus fibrosis, fascia lata, flexor
tendons, etc. In one particular application, an anastomosis is
performed over a balloon and the methods and devices of the present
invention are used to repair the vessel.
[0416] Also, tissue may be repaired after an implant has been
inserted within the body. Such implant insertion procedures
include, but are not limited to, partial or total knee replacement
surgery, hip replacement surgery, bone fixation surgery, etc. The
implant may be an organ, partial organ grafts, tissue graft
material (autogenic, allogenic, xenogenic, or synthetic), collagen,
a malleable implant like a sponge, mesh, bag/sac/pouch, collagen,
or gelatin, or a rigid implant made of metal, polymer, composite,
or ceramic. Other implants include breast implants, biodegradable
plates, porcine or bovine patches, metallic fasteners, compliant
bearing for medial compartment of the knee, nucleus pulposus
prosthetic, stent, tissue graft, tissue scaffold, biodegradable
collagen scaffold, and polymeric or other biocompatible scaffold.
The scaffold may include fetal cells, stem cells, embryonal cells,
enzymes, and proteins.
[0417] The present invention further provides flexible and rigid
fixation of tissue. Both rigid and flexible fixation of tissue
and/or an implant provides compression to enhance the healing
process of the tissue. A fractured bone, for example, requires the
bone to be realigned and rigidly stabilized over a period time for
proper healing. Also, bones may be flexibly secured to provide
flexible stabilization between two or more bones. Soft tissue, like
muscles, ligaments, tendons, skin, etc., may be flexibly or rigidly
fastened for proper healing. Flexible fixation and compression of
tissue may function as a temporary strut to allow motion as the
tissue heals. Furthermore, joints which include hard and soft
tissue may require both rigid and flexible fixation to enhance
healing and stabilize the range of motion of the joint. Flexible
fixation and compression of tissue near a joint may provide motion
in one or more desired planes. The fasteners described herein and
incorporated by reference provide for both rigid and flexible
fixation.
[0418] Although the invention is described primarily on a
macroscopic level, it is also envisioned that the present invention
can be used for microscopic applications. For example, in the
repair of nerve tissue, individual cells or fibers may need to be
repaired. Similarly, muscle repair may require tightening of
individual muscle fibers.
[0419] System 900 includes a distal fastener 906 contacting
fracture portion 902, a proximal fastener 908 contacting bone 904,
and an elongate fastening member 910 extending through the fracture
and coupling distal and proximal fasteners 906, 908. Tension is
maintained in elongate fastening member 910 to press fasteners 906,
908 against opposite sides of bone 904 with a desired force. This
force presses fracture portion 902 against bone 904 firmly together
to promote healing of the fracture. If desired, buttons or other
force distributing members could be provided between fasteners 906,
908 and the bone. Although FIG. 44 shows distal and proximal
fasteners 906, 908 as having the same construction, they could have
differing construction. However, for convenience and practical
purposes, it may be beneficial if distal and proximal fasteners 906
and 908 have substantially the same construction.
[0420] FIGS. 45-48 show an exemplary embodiment of a fastener 912
that can be used as part of system 900, i.e. as either or both of
distal and proximal fasteners 906, 908. Fastener 912 has a body 914
that is configured and dimensioned to facilitate implantation
through minimally invasive procedures, e.g. through a cannula or
sleeve. In particular, body 914 includes a tissue contacting
surface 916 that is provided with groove 1018 that receives a
portion of elongate fastening member 910 when fastener 912 is in a
first orientation with respect to elongate fastening member 910.
This is seen in FIG. 49. The accommodation of elongate fastening
member 910 within groove 918 helps to minimize the profile of the
assembly of fastener 912 and elongate fastening member 910. The
reduced profile can be more readily passed through a cannula or
sleeve. If desired, an adhesive can be provided within groove 918
to bias fastener 912 in the first orientation. Alternatively, a
frangible connection can be provided between groove 918 and the
portion of elongate fastening member 910. This frangible connection
keeps fastener 912 in the first orientation with respect to
elongate fastening member 910 until it is broken.
[0421] Fastener 912 is provided with first and second ends 920,
922. As shown in FIG. 49, first end 920 is the leading end and
second end 922 is the trailing end. In this position, when fastener
912 is pivoted to a second orientation, like distal fastener 906 of
FIG. 44, tissue contacting surface 916 is in contact with the
tissue. As shown in FIGS. 50 and 51, second end 922 is the leading
end and first end 920 is the trailing end. In this position, when
fastener 912 is pivoted to the second orientation, like proximal
fastener 908 of FIG. 44, tissue contacting surface 916 is in
contact with the tissue.
[0422] Fastener body 914 has a free surface 924 opposite tissue
contacting surface 916. Free surface 924 is provided with a channel
926 that receives a portion of elongate fastening member 910 when
fastener 912 is in a first orientation with respect to elongate
fastening member 910. As shown in FIGS. 50 and 51, fastener 912 is
being slid along elongate fastening member 910. In particular, a
through bore 928 extends from tissue contacting surface 916 through
free surface 924. Through bore 928 is larger in diameter than
elongate fastening member 910 so that fastener 912 freely slides
along elongate fastening member 910. A portion of elongate
fastening member 910 fits within channel 926 on free surface 924
and a portion of elongate fastening member 910 fits within groove
918 on tissue contacting surface 916.
[0423] Fastener body 914 is shown with first end 920 having a
substantially flat profile and second end 922 having a tapered
profile. In general, any suitable external configuration can be
used for fastener 912. Examples of fasteners may be found in U.S.
Pat. Nos. 5,163,960; 5,403,348; 5,464,426; 5,549,630; 5,593,425;
5,713,921; 5,718,717; 5,782,862; 5,814,072; 5,814,073; 5,845,645;
5,921,986; 5,948,002; 6,010,525; 6,045,551; 6,159,234; 6,368,343;
6,447,516; 6,475,230; 6,592,609; 6,635,073; 6,719,765; 7,094,251;
and 7,329,263. Other fastener types are disclosed in U.S. Patent
Application Publication Nos. 2003/0181800, 2004/0230223, and
2004/0220616. The above cited patents and patent applications are
hereby incorporated by reference.
[0424] Fastener 912 can be made of any biocompatible material
suitable for a given application. For example, the fasteners may
be, but are not limited to, degradable, biodegradable, bioerodible,
bioabsorbable, mechanically expandable, hydrophilic, bendable,
deformable, malleable, riveting, threaded, toggling, barbed,
bubbled, laminated, coated, blocking, pneumatic, one-piece,
multi-component, solid, hollow, polygon-shaped, pointed,
self-introducing, and combinations thereof. Also, the fasteners may
include metallic material, polymeric material, ceramic material,
composite material, body tissue, synthetic tissue, hydrophilic
material, expandable material, compressible material, heat bondable
material, and combinations thereof. Examples of body tissue include
bone, collagen, cartilage, ligaments, or tissue graft material like
xenograft, allograft, and autograft. The fasteners may also be made
from a porous matrix or mesh of biocompatible and bioresorbable
fibers acting as a scaffold to regenerate tissue.
[0425] The fasteners may further be made of or have a coating made
of an expandable material. The material could be compressed then
allowed to expand. Alternatively, the material could be hydrophilic
and expand when it comes in contact with liquid. Examples of such
expandable materials are ePTFE and desiccated body tissue.
[0426] Moreover, the fasteners described herein and incorporated by
reference may include therapeutic substances to promote healing.
These substances could include antibiotics, hydroxyapatite,
anti-inflammatory agents, steroids, antibiotics, analgesic agents,
chemotherapeutic agents, bone morphogenetic protein (BMP),
demineralized bone matrix, collagen, growth factors, autogenetic
bone marrow, progenitor cells, calcium sulfate, immo suppressants,
fibrin, osteoinductive materials, apatite compositions, germicides,
fetal cells, stem cells, enzymes, proteins, hormones, cell therapy
substances, gene therapy substances, and combinations thereof.
These therapeutic substances may be combined with the materials
used to make the fasteners to produce a composite fastener.
Alternatively, the therapeutic substances may be impregnated or
coated on the fastener. Time-released therapeutic substances and
drugs may also be incorporated into or coated on the surface of the
fastener. The therapeutic substances may also be placed in a
bioabsorbable, degradable, or biodegradable polymer layer or
layers.
[0427] FIG. 52A shows an exemplary embodiment of an elongate
fastening member 930. Elongate fastening member 930 includes a body
932 and has a stop 934 at a distal end. Body 932 can be selected
for a given application. For example, if a rigid elongate fastening
member 930 is needed, body 932 can be a rod or a tube. If a more
flexible elongate fastening member 930 is needed, body 932 can be a
suture. In general, a wire analogous to those used for cerclage of
bone fractures is believed to provide a suitable combination of
strength and flexibility. Although body 932 is shown as a single
strand wire, the invention can be used with any type of surgical
cable, such as a multi-strand cable.
[0428] Stop 934 can be made integral with body 932 or separate and
then attached. Stop 934 is larger in diameter than through bore 928
in body 914 of fastener 912. Thus, once stop 934 reaches through
bore 928, fastener 912 cannot be slid any further along elongate
fastening member 930. As shown in FIG. 48, free surface 924 of
fastener 912 is provided with a well 936 surrounding through bore
928. Well 936 is configured and dimensioned to receive at least a
portion of stop 934. As shown in FIG. 53, this helps reduce the
profile of the assembly when fastener 912 is in a second
orientation with respect to elongate fastening member 930.
[0429] Referring to FIG. 52B, in another embodiment, the elongated
fastener member 930 includes expandable members 931, positioned
along the body 932. Upon insertion into the tissue, the expandable
members 931 expand to engage the surrounding tissue. For examples,
the expandable members 931 can be barbs. The barbs 931 engage the
surrounding tissue, maintaining the elongated fastener member's 930
position within the tissue.
[0430] The elongate fastening members of the present invention may
be made of metallic material, non-metallic material, composite
material, ceramic material, polymeric material, co polymeric
material, or combinations thereof. The members may be degradable,
biodegradable, bioabsorbable, or nonbiodegradable. Examples of
suture materials that can be used for the elongate fastening
members are polyethylene, polyester, cat gut, silk, nylon,
polypropylene, linen, cotton, and copolymers of glycolic and lactic
acid. Preferably, the members are flexible or bendable. They may be
threadlike, monofilament, multifilament, braided, or interlaced.
The members may have a coating of therapeutic substances or drugs.
For example, the members may include antibiotics, hydroxyapatite,
anti-inflammatory agents, steroids, antibiotics, analgesic agents,
chemotherapeutic agents, bone morphogenetic protein, demineralized
bone matrix, collagen, growth factors, autogenetic bone marrow,
progenitor cells, calcium sulfate, immo suppressants, fibrin,
osteoinductive materials, apatite compositions, fetal cells, stem
cells, enzymes, proteins, hormones, and germicides.
[0431] The use of the tissue fixation system according to the
present invention will now be described using fracture fixation as
an example. If necessary, the fracture is reduced bringing fracture
portion 902 into contact with bone 904 (FIG. 54). The reduction can
be achieved using any number of techniques.
[0432] As also shown in FIG. 54, a drill system 938 is used to
drill across the fracture, thereby creating a passage completely
through bone 904. Drill system 938 includes a drill bit 940 with a
headpiece configured for attachment to a drill. A drill stop can be
placed on the headpiece and prevents drill bit 940 from penetrating
too far beyond the tissue to be drilled. Drill system 938 may be a
cannulated drill system that fits over a k-wire or other similar
guide wire. A cannula or sleeve 942 may encircle drill bit 940 or
at least the shaft portion of drill bit 940. As drill bit 940
creates a passage through bone 904, sleeve 942 is positioned in the
passage. Drill system 938 is used to create a passage in bone 904
from the proximal side of bone 904 to the distal side of bone 904,
then the drill and drill bit 940 are removed from sleeve 942 (FIG.
55).
[0433] As shown in FIG. 56, a distal fastener 912a is inserted into
sleeve 942. Distal fastener 912a is inserted in the first
orientation with respect to elongate fastening member 930 with
first end 920 as the leading end. In this configuration, tissue
contacting surface 916 will be in contact with fracture portion 902
when distal fastener 912a is pivoted into the second orientation.
This is best seen in FIGS. 57 and 58, in which a pushrod 944 is
used to advance distal fastener 912a and elongate fastening member
930 through sleeve 942. Pushrod 944 also facilitates the pivoting
of distal fastener 912a from the first orientation to the second
orientation. This pivoting is not possible until distal fastener
912a has exited through sleeve 942. Also, since the length of
distal fastener 912a is larger than the passage created in bone
904, pulling back on elongate fastening member 930 helps to ensure
distal fastener 912a is in the second orientation and flush against
fracture portion 902.
[0434] As illustrated in FIG. 59, sleeve 942 is removed from bone
904. Fastener 912a is located on the distal side of bone 904.
Elongate fastening member 930 extends from fastener 912a through
the bone passage and out the proximal opening of the bone or tissue
passage. Any suitable means can be used to keep distal fastener
912a against fracture portion 902 with tension, where the tension
can be measure and controlled in accordance with use. For example,
elongate fastening member 930 can be deformed at the proximal end
of the passage such that the deformed section rests against bone
904. The deformation would depend on the nature of elongate
fastening member 930. If elongate fastening member 930 is a
relatively flexible element, such as a suture, cable, or wire, then
simply tying a knot in fastening member 930 could be sufficient to
maintain the tension. If elongate fastening member 930 does not
allow a knot, such as would be the case with a rod or tube, then
mechanical deformation of elongate fastening member 930 to create
an enlarged head could be sufficient to maintain the tension. U.S.
Pat. No. 7,361,178, the contents of which are incorporated herein
by reference, discloses mechanisms to mechanically deform an
extension member and could be used to deform elongate fastening
member 930.
[0435] Alternatively, the elongated fastening member 930 can be
deformed by an energy, such as thermal energy, to deform elongate
fastening member 930 to create an enlarged head sufficient to
maintain the tension.
[0436] In an exemplary embodiment, a proximal fastener 912b is used
to secure distal fastener 912a and elongate fastening member 930.
In this embodiment, proximal fastener 912b is identical to distal
fastener 912a. If not already pre-loaded, proximal fastener 912b is
loaded onto elongate fastening member 930. Proximal fastener 912b
is loaded as shown in FIGS. 50 and 51, i.e. with second end 922 as
the leading end so that after proximal fastener 912b is slid down
against bone 904 and pivoted into the second orientation, tissue
contacting surface 916 is in contact with bone 904.
[0437] Elongate fastening member 930 is tensioned, and proximal
fastener 912b is secured to elongate fastening member 930 to
thereby approximate the fracture and stabilize bone 904. The
tension of elongate fastening member 930 pulls on distal and
proximal fasteners 912a, 912b generally toward each other, thereby
applying pressure to the fractured bone or tissue. In this regard,
a bushing 946 can be used to secure proximal fastener 912b with the
desired tension. Single or multiple elongated members 930 can be
used to secure the fractured bone or tissue.
[0438] Although a number of mechanisms can be used to secure
bushing 946, an instrument or medical device particularly useful
for this will now be described.
[0439] In this regard, the present invention also provides a
medical device for securing a fastener against relative movement
with respect to a cable. As previously disclosed, a cable and pair
of oppositely spaced fasteners can be used to secure a bone
fracture. The cable is passed through the bone and fracture; a
first fastener secures the cable on a first side (fracture side) of
the bone; and a second fastener is positioned about the cable on a
second side of the bone, opposite the first fastener. A bushing is
positioned onto the cable to secure the second fastener against the
second side of the bone. A force is applied to the bushing,
compressing the second fastener against the second side of the bone
and providing a tension to the cable. The tension in the cable can
be measured and controlled, for example, with the used of a sensor
and spring element. The spring can apply the force to tension the
cable, and the sensor can be used to measure the resulting tension.
Alternatively, the sensor can measure the compression of the tissue
to determine the tension. The bushing is crimped about the cable,
securing the second fastener against the second side of the bone,
such that a tension is provided through the cable between the first
and second fasteners.
[0440] Referring to FIG. 60, a medical device 1200 is provided for
securing the bushing to the cable. The medical device 1200 includes
a handle portion 1202 having a tensioning mechanism 1204,
tensioning the cable and applying a force to the bushing, and a
crimping mechanism 1206 for securing the bushing to the cable.
[0441] Referring also to FIGS. 61 and 62, the tensioning mechanism
1204 includes a collett holder 1208 defining a longitudinal passage
along a central longitudinal axis A. The collett holder 1208 is
affixedly positioned through a top portion 1212 of the handle
portion 1202 with collett holder pin 1214. A cable tensioner 1216
is slidably positioned on a first end 1218 of the collett holder
1208. The cable tensioner 1216 defines a cable passage
longitudinally aligned with the longitudinal passage of the collett
holder 1208. An end portion 1222 of the cable tensioner 1216
includes a cable aperture 1224 for threading the cable there
through. A radial groove 1226 and circumferential groove 1228 are
provided on the end portion 1222 of the cable tensioner 1216, such
that the cable can be wrapped about the circumferential groove 1228
of the cable tensioner 1216, thereby preventing relative movement
between the cable and the cable tensioner 1216.
[0442] A cable tension lever 1230 is pivotally connected to the
cable tensioner 1216 with a lever pin 1232. The cable tension lever
1230 is adjustably positioned on the handle portion 1202 with body
pins 1234, wherein a body pin 1234 is mirrorly positioned on
opposite sides of the handle portion 1202. The body pins 1234 are
engaged in the cable tension lever 1230 arcuate lever slots 1236,
such that cable tension lever 1230 and cable tensioner 1216 are
movably connected to the handle portion 1202.
[0443] In use, as the cable tension lever 1230 is pivoted about the
cable tensioner 1216 from a first lever position L1 to a second
lever position L2, the body pins 1234 traverse the arcuate lever
slots 1236, resulting in a translation of the cable tensioner 1216
along the first end 1218 of the collett holder 1208 from a first
tensioner position T1 to a second tensioner position T2. A tension
bias member 1238 is interposed between the cable tensioner 1216 and
the handle portion 1202, biasing the cable tensioner 1216 into the
first tensioner position T1. The cable tension lever 1230 includes
tension indicating markings 1240 along each of the arcuate lever
slots 1236. The tension markings 1240 indicate the tension to be
applied to the cable.
[0444] Referring also to FIG. 77 an alternative cable tensioner 440
is provided. Cable tensioner 440 is slidably positioned on a first
end 1218 of the collett holder 1208. The cable tensioner 440
defines a cable passage longitudinally aligned with the
longitudinal passage of the collett holder 1208. An end portion 442
of the cable tensioner 440 includes a cleat 444 and a cleat stop
446. The cleat 444 is pivotally mounted to the cable tensioner 440,
including a bias member 448 biasing the cleat 444 into a closed
position. A cable 450 is threadable between the cleat 446 and the
cleat stop 448, where in the closed position the cleat 446 imparts
a force onto the cable 450, securing the cable 450 in the cable
tensioner 440.
[0445] The bias member 448 biases the cleat 444 such that in the
closed position the cable can be further drawn through the cable
tensioner 440, for example, to position the fastener proximal to
the tissue while removing any initial slack from the cable 450.
However, the cleat 444 prevents the cable 450 from being drawn back
through the cable tensioner 440. For example, the cleat 444 can
include an arcuate contact surface 452 such that the force imparted
on the cable 450 in the closed position increases as the tension on
the cable 450 increases, preventing the cable 450 from being drawn
back through the cable tensioner 440. The cleat arcuate surface 452
can further include a plurality of teeth 454, which can be utilized
to grip cable 450.
[0446] Referring to FIGS. 61 and 63, a collett 1242 is affixed to a
second end portion 1244 of the collett holder 1208, opposite the
cable tensioner 1216. The collett 1242 defines a collett passage
longitudinally aligned with the longitudinal passage of the collett
holder 1208 along the central longitudinal axis A. An end portion
of the collett 1242 is bisected, forming first and second collett
arms 1248 and 1250. A gap portion 1252 is provided between the
first and second collett arms 1248 and 1250. Each of the first and
second collett arms 1248 and 1250 includes force application end
portions 1254 and 1256. The force application end portions 1254 and
1256 combine to form a bushing aperture 1258 configured to received
the bushing therein. The collett 1242 is made of a semi-rigid
material, such that the first and second collett arms 1248 and 1250
can be moved from an open to a closed position, closing the gap
1252 between the force application end portions 1254 and 1256.
[0447] In use, the tensioning mechanism 1204 is used to tension the
cable. The cable can include a single or multiple filaments. The
cable is inserted through the medical device 1200 along the central
longitudinal axis A, through the collett 1242, collett holder 208,
and the cable tensioner 1216, positioning the bushing in the
bushing aperture 1258 and extending the cable through the cable
aperture 1224. To tension the cable, the cable tension lever 1230
is actuated from the first lever position L1 to the second lever
position L2, sliding the cable tensioner 1216 along the collett
holder 1208 from the first tensioner position T1, into the handle
portion 1202 against the tension bias member 1238, to the second
tensioner position T2. The cable is positioned through the radial
groove 1226 and wrapped about the circumferential groove 1228 on
the end portion 1222 of the cable tensioner 1216, securing the
cable to the cable tensioner 1216. The cable tension lever 1230 is
released, such that tension bias member 1238 biases the cable
tensioner 1216 from the second tensioner position T2 towards the
first tensioner position T1. The movement of the cable tensioner
1216 towards the first tensioner position T1 applies a tension to
the cable, forcing the bushing into the second fastener. The
applied tension can be selected by actuating the cable tension
lever 1230 to the desired tension marking 1240.
[0448] Referring again to FIGS. 60 and 64, the crimping mechanism
1206 includes an outer tube 1260 slidingly positioned over the
collett holder 1208. The outer tube 1260 includes a first end 1262
operably connected to a trigger 1264 and a second end 1266
connected to a collett closer 1268. The trigger 1264 is pivotally
mounted in the handle portion 1202, such that the trigger 1264 can
be actuated from a first trigger position TR1 to a second trigger
position TR2. A locking mechanism 1265 prevents the trigger 1264
from being actuated. The locking mechanism 1265 is rotated to
disengage the trigger 1264, allowing actuation of the trigger
1264.
[0449] The operable connection between the first end of the outer
tube 1262 and the trigger 1264 includes an outer tube ferrule 1270
slidably positioned about the collett holder 1208 and affixed to
the first end of the outer tube 1262. A tube bias member 1272 is
interposed between the handle portion 1202 and the outer tube
ferrule 1270, such that the tube bias member 1272 biases the outer
tube ferrule 1270 and the outer tube 1260 into a first tube
position P1. A pair of crimp cams 1274 are pivotally connected to
the handle portion 1202 on opposite sides of the trigger 1264. The
crimp cams 1274 each include first edges 1276 having an arcuate
section 1278 for engaging the outer tube ferrule 1270, where the
crimp cams 1274 are translatable with respect to the handle portion
1202 from a first cam position C1 to a second cam position C2.
[0450] An actuation of the trigger 1264 from a first trigger
position TR1 to a second trigger position TR2 translated the crimp
cams 1274 with respect to the handle portion from a first cam
position C1 to a second cam position C2 position. The arcuate
sections 1278 of the crimp cams 1274 engage the outer tube ferrule
1270, translating the outer tube ferrule 1270 and the outer tube
1260 along the collett holder 1208 from the first tube position P1
to a second tube position P2. As the trigger 1264 is released, the
tube bias member 1272 biases the outer tube ferrule 1270 and the
outer tube 1260 from the second tube position P2 to the first tube
position P1. Simultaneously, the crimp cams 1274 and the trigger
1264 are moved to the first cam position C1 and the first trigger
position TR1.
[0451] Referring to FIGS. 60 and 65, the collett closer 1268 is
positioned on the outer tube 1260 proximal to the force application
end portions 1254 and 1256 of the first and second collett arms
1248 and 1250. As the outer tube 1260 is moved from the first tube
position P1 to the second tube position P2, the collett closer 1268
is moved over the force application end portions 1254 and 1256. The
collett closer 1268 includes inner tapered surfaces 1280, such that
the inner tapered surfaces 1280 apply compressive forces to the
force application end portions 1254 and 1256 as the collett closer
1268 is moved over the force application end portions 1254 and
1256, closing the gap 1252 there between.
[0452] In use, the trigger 1264 is actuated from the first trigger
position TR1 to the second trigger position TR2. The actuation of
the trigger 1264 slides the outer tube 1260 along the collett
holder 1208 from the first tube position P1 to the second tube
position P2, moving collett closer 1268 about the force application
end portions 1254 and 1256 of the first and second collett arms
1248 and 1250. The inner tapered surfaces 1280 of the collett
closer 1268 apply compressive forces to the first and second force
application end portions 1254 and 1256, closing the gap 1252 there
between. The trigger 1264 is released, allowing the tube bias
member 1272 to bias the outer tube 1260 from the second tube
position P2 to the first tube position P1, moving the collett
closer 1268 from the force application end portions 1254 and
1256.
[0453] Referring to FIGS. 66-68, the crimping mechanism 1206 can
further include a cutting mechanism. The cutting mechanism includes
a cut off cam 1284 slidingly positioned along a bottom portion of
the collett holder 1208. The cut off cam 1284 includes a first end
portion 1286 positioned through the outer tube ferrule 1270. A cut
off cam ring 1288 is slidably positioned about the collett holder
1208, engaging the first end portion 1286 of the cut off cam 1284.
The cut off cam ring 1288 is positioned proximal to the trigger
1264, such that as the trigger 1264 is actuated from the first
trigger 1264 position TR1 to the second trigger 1264 position TR2,
a top portion 1290 of the trigger 1264 engages the cut off cam ring
1288, sliding the cut off cam ring 1288 and cut off cam 1284 along
the collett holder 1208. A cut off bias member 1291 is interposed
between the outer tube ferrule 1270 and the cut off cam ring
1288.
[0454] A cut off arm 1292 is connected to the collett 1242, at
least partially positioned in the gap 1252 between the first and
second collett arms 1248 and 1250. The cut off arm 1292 includes a
cutting head portion 1294 positioned proximal to the first and
second force application end portions 1254 and 1256, at least
partially positioned in the gap 1252, interposed between the first
and second collett arms 1248 and 1250. The cutting head portion
1294 includes a cutting edge 1296, for cutting the cable, and a
lower angular surface 1298 for engagement by a second end portion
1300 of the cut off cam 1284.
[0455] In use, the trigger 1264 is actuation from the first trigger
position TR1 to the second trigger position TR2. The actuation of
the trigger 1264 results in the top portion 1290 of the trigger
1264 engaging the cut off cam ring 1288, sliding the cut off cam
ring 1288 and cut off cam 1284 along the collett holder 1208. The
second end portion 1300 of the cut off cam 1284 engages the angular
surface 1298 of the cutting head 1294, forcing the cutting edge
1296 into the cable, cutting the cable. The trigger 1264 is
released, allowing the cut off bias member 1291 to bias the cut off
cam 1284 from the cutting head 1294.
[0456] Referring to FIG. 69, in a method of use, the cable is
passed through the bone and fracture, where a first fastener
secures the cable on a first side (fracture side) of the bone and a
second fastener is positioned about the cable on a second side of
the bone, opposite the first fastener. A bushing is positioned onto
the cable to secure the second fastener against the second side of
the bone.
[0457] The cable is inserted through the medical device 1200 along
the central longitudinal axis "A", through the collett 1242,
collett holder 1208, and the cable tensioner 1216, positioning the
bushing in the bushing aperture 1258 and extending the cable
through the cable aperture 1224. To tension the cable, the cable
tension lever 1230 is actuated from the first lever position L1 to
the second lever position L2, sliding the cable tensioner 1216
along the collett holder 1208 from the first tensioner position T1,
into the handle portion 1202 against the tension bias member 1238,
to the second tensioner position T2. The cable is positioned
through the radial groove 1226 and wrapped about the
circumferential groove 1228 on the end portion 1222 of the cable
tensioner 1216, securing the cable to the cable tensioner 1216. The
cable tension lever 1230 is released, such that tension bias member
1238 biases the cable tensioner 1216 from the second tensioner
position T2 towards the first tensioner position T1. The movement
of the cable tensioner 1216 towards the first tensioner position T1
applies a tension to the cable, pressing the bushing against the
second fastener. The applied tension can be selected by actuating
the cable tension lever 1230 to the desired tension marking
1240.
[0458] The trigger 1264 is actuated from the first trigger position
TR1 to the second trigger position TR2. The actuation of the
trigger 1264 slides the outer tube 1260 along the collett holder
1208 from the first tube position P1 to the second tube position
P2, moving collett closer 1268 about the force application end
portions 1254 and 1256 of the first and second collett arms 1248
and 1250. The inner tapered surfaces 1280 of the collett closer
1268 apply compressive forces to the first and second force
application end portions 1254 and 1256, compressing the first and
second force application end portions 1254 and 1256 about the
bushing positioned in the bushing aperture 1258. The compressive
forces crimp the bushing about the cable, securing the bushing to
the cable.
[0459] Simultaneously, the actuation of the trigger 1264 results in
the top portion 1290 of the trigger 1264 engaging the cut off cam
ring 1288, sliding the cut off cam ring 1288 and cut off cam 1284
along the collett holder 1208. The second end portion 1300 of the
cut off cam 1284 engages the angular surface 1298 of the cutting
head 1294, forcing the cutting edge 1296 into the cable, cutting
the cable.
[0460] In another embodiment a medical device 1320 of the present
invention secures a fastener against relative movement with respect
to a suture, with the fastener itself being deformed. Medical
device 1320 is substantially similar to medical device 1200 and
like reference number shall be used to indicate like items.
[0461] Referring to FIGS. 70 and 71, medical device 1320 includes
collett 1322. As with collett 1242, previously disclosed and
illustrated, collett 1322 is affixed to the second end portion 1244
of the collett holder 1208, opposite the cable tensioner 1216. The
collett 1322 defines a collett passage longitudinally aligned with
the longitudinal passage of the collett holder 1208, along the
central longitudinal axis A. An end portion of the collett 1322 is
bisected, forming first and second collett arms 1324 and 1326. A
gap portion 1328 is provided between the first and second collett
arm 1324 and 1326. Each of the first and second collett arms 1324
and 1326 includes force application end portions 1330 and 1332. The
force application end portions 1330 and 1332 combine to form a
fastener aperture 1334 configured to receive the fastener therein.
The force application end portions 1330 and 1332 each include
opposing compressive members 1336 for compressing the fastener
about the suture.
[0462] Referring to FIGS. 70 and 72, medical device 1320 includes
collett closer 1340. The collett closer 1340 is positioned on the
outer tube 1260 proximal to the force application end portions 1330
and 1332 of the first and second collett arms 1324 and 1326. The
collett closer 1340 includes slotted sections 1342 configured for
receiving end portions of the fastener therein. As the outer tube
1260 is moved from the first tube position P1 to the second tube
position P2, the collett closer is moved over the force application
end portions 1330 and 1332. Similar to collett closer 1268, the
collett closer 1340 includes inner tapered surfaces 1280 (See FIG.
65), such that the inner tapered surfaces 1280 apply compressive
forces to the force application end portions 1330 and 1332 as the
collett closer 1340 is moved over the force application end
portions 1330 and 1332, closing the gap 1328 there between.
[0463] Referring to FIGS. 73 and 74, in a method of use suture 1360
is inserted through the bone 1362 and fracture 1364, where the
suture 1360 is threaded through a fastener 1366 on a first side
(fracture side) of the bone 1362. The suture 1360 is reinserted
through the fracture 1364 and bone 1362, such that first and second
ends 1368 and 1370 of the suture 1360 extend from the bone 1362.
The first and second ends of the suture 1368 and 1370 are threaded
through a fastener 1372, where the first end of the suture 1368 is
threaded through a first aperture 1374 in the fastener 1372 and the
second end of the suture 1370 is threaded through a second aperture
1376 in the fastener 1372.
[0464] Referring also to FIG. 69, the ends of the suture 1368 and
1370 are inserted through the medical device 1320 along the central
longitudinal axis A, through the collett 1322, collett holder 1208,
and the cable tensioner 1216, positioning the fastener 1372 in the
fastener aperture 1334 and extending the ends of the suture 1368
and 1370 through the cable aperture 1224. To tension the suture
1360, the cable tension lever 1230 is actuated from the first lever
position L1 to the second lever position L2, sliding the cable
tensioner 1216 along the collett holder 1208 from the first
tensioner position T1, into the handle portion 1202 against the
tension bias member 1238, to the second tensioner position T2. The
suture ends 1368 and 1370 are positioned through the radial groove
1226 and wrapped about the circumferential groove 1228 on the end
portion 1222 of the cable tensioner 1216, securing the suture 1360
to the cable tensioner 1216. The cable tension lever 1230 is
released, such that tension bias member 1238 biases the cable
tensioner 1216 from the second tensioner position T2 towards the
first tensioner position T1. The movement of the cable tensioner
1216 towards the first tensioner position T1 applies tension to the
suture 1360, compressing the fastener 1372 against the bone 1362.
The applied tension can be selected by actuating the cable tension
lever 1230 to the desired tension marking 1240.
[0465] The trigger 1264 is actuation from the first trigger
position TR1 to the second trigger position TR2. The actuation of
the trigger 1264 slides the outer tube 1260 along the collett
holder 1208 from the first tube position P1 to the second tube
position P2, moving collett closer 1340 about the force application
end portions 1330 and 1332 of the first and second collett arms
1324 and 1326. The inner tapered surfaces 1280 of the collett
closer 1340 apply compressive forces to the first and second force
application end portions 1330 and 1332, compressing compressive
members 1336 of the first and second force application end portions
1330 and 1332 into the first and second fastener apertures 1374 and
1376. The compressive forces crimp the first and second fastener
apertures 1374 and 1376 about the suture ends 1368 and 1370,
securing the fastener 1372 to the suture ends 1368 and 1370.
[0466] Simultaneously, the actuation of the trigger 1264 results in
the top portion 1290 of the trigger 1264 engaging the cut off cam
ring 1288, sliding the cut off cam ring 1288 and cut off cam 1284
along the collett holder 1208. The second end portion 1200 of the
cut off cam 1283 engages the angular surface 1298 of the cutting
head 1294, forcing the cutting edge 1296 into the suture ends 1268
and 1270, cutting the suture ends 1368 and 1370.
[0467] Referring to FIG. 75, similar to FIGS. 61 and 63, a collett
400 is affixed to a second end portion 1244 of the collett holder
1208, opposite the cable tensioner 1216. The collett 400 defines a
collett passage longitudinally aligned with the longitudinal
passage of the collett holder 1208 along the central longitudinal
axis A. An end portion of the collett 400 is bisected, forming
first and second collett arms 402 and 404. A gap portion 406 is
provided between the first and second collett arms 402 and 404.
Each of the first and second collett arms 402 and 404 includes
force application end portions 408 and 410. The force application
end portions 408 and 410 combine to form a bushing aperture 412
configured to received the bushing therein 414. The collett 400 is
made of a semi-rigid material, such that the first and second
collett arms 402 and 404 can be moved from an open to a closed
position, closing the gap 406 between the force application end
portions 408 and 410.
[0468] Referring also to FIG. 75, in a method of use, suture 416 is
inserted through the bone 418 and fracture 420, where the suture
416 is threaded through a fastener 422 on a first side (fracture
side) of the bone 424. The suture 416 is reinserted through the
fracture 420 and bone 418, such that first and second ends 426 and
428 of the suture 416 extend from the bone 418. The first and
second ends of the suture 426 and 428 are threaded through a
fastener 414, where the first and second ends 426 and 428 of the
suture 416 is threaded through an aperture 430 in the fastener
414.
[0469] Referring also to FIGS. 69 and 72, the ends of the suture
426 and 428 are inserted through the medical device 1320 along the
central longitudinal axis A, through the collett 400, collett
holder 1208, and the cable tensioner 1216, positioning the fastener
414 in the fastener aperture 412 and extending the ends of the
suture 426 and 428 through the cable aperture 1224. To tension the
suture 416, the cable tension lever 1230 is actuated from the first
lever position L1 to the second lever position L2, sliding the
cable tensioner 1216 along the collett holder 1208 from the first
tensioner position T1, into the handle portion 1202 against the
tension bias member 1238, to the second tensioner position T2. The
suture ends 426 and 428 are positioned through the radial groove
1226 and wrapped about the circumferential groove 1228 on the end
portion 1222 of the cable tensioner 1216, securing the suture 1360
to the cable tensioner 1216. The cable tension lever 1230 is
released, such that tension bias member 1238 biases the cable
tensioner 1216 from the second tensioner position T2 towards the
first tensioner position T1. The movement of the cable tensioner
1216 towards the first tensioner position T1 applies tension to the
suture 416, compressing the fastener 414 against the bone 418. The
applied tension can be selected by actuating the cable tension
lever 1230 to the desired tension marking 1240.
[0470] The trigger 1264 is actuated from the first trigger position
TR1 to the second trigger position TR2. The actuation of the
trigger 1264 slides the outer tube 1260 along the collett holder
1208 from the first tube position P1 to the second tube position
P2, moving collett closer 1340 about the force application end
portions 408 and 410 of the first and second collett arms 402 and
404. The inner tapered surfaces 1280 of the collett closer 1340
apply compressive forces to the first and second force application
end portions 408 and 410. The compressive forces crimp the aperture
430 about the suture ends 426 and 428, securing the fastener 414 to
the suture ends 426 and 428.
[0471] Referring to FIG. 79, a medical device 500 is provided for
securing the bushing to the cable. The medical device 500 includes
a handle portion 502 having a tensioning mechanism 504, tensioning
the cable and applying a force to the bushing, and a crimping
mechanism 506 for securing the bushing to the cable.
[0472] Referring also to FIGS. 80 and 81, the tensioning mechanism
504 includes a collett holder 508 defining a longitudinal passage
along a central longitudinal axis A. The collett holder 508 is
affixedly positioned through a top portion 510 of the handle
portion 502. A cable tensioner 512 is slidably positioned on a
first end 514 of the collett holder 508. The cable tensioner 512
defines a cable passage longitudinally aligned with the
longitudinal passage of the collett holder 508. An end portion 516
of the cable tensioner 512 includes a cable aperture for threading
the cable there through. A radial groove and circumferential groove
518 are provided on the end portion 516 of the cable tensioner 512,
such that the cable can be wrapped about the circumferential groove
518 of the cable tensioner 512, thereby preventing relative
movement between the cable and the cable tensioner 512.
[0473] In an exemplary embodiment, the cable tensioner 512 can
include a retention bushing 520 and a tension insert 522. The
tension insert 522 defines a cable passage longitudinally aligned
with the longitudinal passage of the cable tensioner 512. The
retention bushing 520 is positioned about a portion of the tension
insert 522, where an end portion 524 is threaded into the end
portion 516 of the cable tensioner 512. An opposite end portion 526
of the tension insert 522 includes a cable aperture 528 for
threading the cable there through. A radial groove 530 is provided
on the end portion 526 of the cable tensioner 512 and the retention
bushing 520 and the tension insert 522 combine to form a
circumferential groove 532, such that the cable can be wrapped
about the circumferential groove 532, thereby preventing relative
movement between the cable and the cable tensioner 512.
[0474] A cable tension lever 534 is pivotally connected to the
cable tensioner 512 with a lever pin 536. The cable tension lever
534 is adjustably positioned on the handle portion 502 with body
pins 538, wherein a body pin 538 is mirrorly positioned on opposite
sides of the handle portion 502. The body pins 538 are engaged in
the cable tension lever 536 arcuate lever slots 540, such that
cable tension lever 534 and cable tensioner 512 are movably
connected to the handle portion 502.
[0475] In use, as the cable tension lever 534 is pivoted about the
cable tensioner 512 from a first lever position L1 to a second
lever position L2, the body pins 538 traverse the arcuate lever
slots 540, resulting in a translation of the cable tensioner 512
along the first end 514 of the collett holder 508 from a first
tensioner position T1 to a second tensioner position T2. A tension
bias member 542 is interposed between the cable tensioner 512 and
the handle portion 502, biasing the cable tensioner 512 into the
first tensioner position T1.
[0476] Referring to FIGS. 80 and 82, a collett 544 is affixed to a
second end portion 546 of the collett holder 508, opposite the
cable tensioner 512. The collett 544 defines a collett passage
longitudinally aligned with the longitudinal passage of the collett
holder 508 along the central longitudinal axis A. An end portion of
the collett 544 is bisected, forming first and second collett arms
548 and 550. A gap portion 552 is provided between the first and
second collett arms 548 and 550. Each of the first and second
collett arms 548 and 550 includes force application end portions
554 and 556. The force application end portions 554 and 556 combine
to form a bushing aperture 558 configured to received the bushing
therein. The collett 544 is made of a semi-rigid material, such
that the first and second collett arms 548 and 550 can be moved
from an open to a closed position, closing the gap 552 between the
force application end portions 554 and 556.
[0477] In use, the tensioning mechanism 504 is used to tension the
cable. The cable can include single or multiple filaments. The
cable is inserted through the medical device 500 along the central
longitudinal axis A, through the collett 544, collett holder 508,
and the cable tensioner 512, positioning the bushing in the bushing
aperture 558 and extending the cable through the cable aperture
530. To tension the cable, the cable tension lever 354 is actuated
from the first lever position L1 to the second lever position L2,
sliding the cable tensioner 512 along the collett holder 508 from
the first tensioner position T1, into the handle portion 502
against the tension bias member 542, to the second tensioner
position T2. The cable is positioned through the radial groove 528
and wrapped about the circumferential groove 532 on the between the
retention bushing 520 and the tension insert 522, securing the
cable to the cable tensioner 512. The cable tension lever 534 is
released, such that tension bias member 542 biases the cable
tensioner 512 from the second tensioner position T2 towards the
first tensioner position T1. The movement of the cable tensioner
512 towards the first tensioner position T1 applies a tension to
the cable, forcing the bushing into the second fastener. The
applied tension can be selected by actuating the cable tension
lever 534 to the desired tension.
[0478] Referring to FIGS. 79 and 83, the crimping mechanism 506
includes an outer tube 560 slidingly positioned over the collett
holder 508. The outer tube 560 includes a first end 562 operably
connected to a trigger 564 and a second end 566 connected to a
collett closer 568. The trigger 1264 is pivotally mounted in the
handle portion 502, such that the trigger 564 can be actuated from
a first trigger position TR1 to a second trigger position TR2. A
locking mechanism 570 prevents the trigger 564 from being actuated.
The locking mechanism 570 is disengaged by rotating it away from
the handle, where the locking mechanism is secured to the trigger
with the locking pawl 572. (See also FIG. 80).
[0479] The operable connection between the first end of the outer
tube 562 and the trigger 564 includes an outer tube ferrule 574
slidably positioned about the collett holder 408 and affixed to the
first end of the outer tube 562. A tube bias member 576 is
interposed between the handle portion 502 and the outer tube
ferrule 574, such that the tube bias member 576 biases the outer
tube ferrule 574 and the outer tube 560 into a first tube position
P1. A tube washer 578 can be provided between the tube ferrule 574
and the bias member 576.
[0480] An actuation of the trigger 564 from a first trigger
position TR1 to a second trigger position TR2 translates the outer
tube ferrule 574 along the collett holder 1208 from the first tube
position P1 to a second tube position P2. In the second tube
position P2 a tube pawl 580 engages the outer tube ferrule 574,
hold the outer tube ferrule in the second tub position P2.
[0481] Referring to FIGS. 79 and 85, the collett closer 568 is
positioned on the outer tube 560 proximal to the force application
end portions 554 and 556 of the first and second collett arms 548
and 550. As the outer tube 560 is moved from the first tube
position P1 to the second tube position P2, the collett closer 568
is moved over the force application end portions 554 and 556. The
collett closer 568 includes inner tapered surfaces 582, such that
the inner tapered surfaces 580 apply compressive forces to the
force application end portions 554 and 556 as the collett closer
568 is moved over the force application end portions 554 and 556,
closing the gap 552 there between.
[0482] In use, the trigger 564 is actuated from the first trigger
position TR1 to the second trigger position TR2. The actuation of
the trigger 564 slides the outer tube 560 along the collett holder
508 from the first tube position P1 to the second tube position P2,
moving collett closer 568 about the force application end portions
554 and 556 of the first and second collett arms 548 and 550. The
inner tapered surfaces 580 of the collett closer 568 apply
compressive forces to the first and second force application end
portions 554 and 556, closing the gap 552 there between.
[0483] Referring to FIGS. 84-86, the crimping mechanism 506 can
further include a cutting mechanism. The cutting mechanism includes
a pair of cut off cams 582 and 584 positioned in the collett gap
552. A pair of wedges 586 and 588 are slidingly positioned along
and on opposite sides of the collett 550 and the collett holder
508. Each of the wedges 586 and 588 include tapered ends 590 and
592 positioned proximal to the cut off arms, such that when the
wedges are moved from a first wedge position W1 to a second wedge
position W2, the tapered ends 590 and 592 compress the cut off cams
582 and 584 together, cutting the cable.
[0484] The handle 502 further includes a wedge pusher 594 slidingly
positioned about the collett holder 508, adjacent to second ends
594 and 596 of wedges 586 and 588. The wedge pusher 594 is slidable
from a first position to a second position, such that the wedges
586 and 588 are moved from the first wedge position W1 to the
second wedge position W2. A rocker 596 is pivotally connected to
the handle 502, such that an actuation of the rocker 596 from a
first rocker position R1 to a second rocker position R2, slides the
wedge pusher 594 from the first position to the second position,
moving wedges 586 and 588 from the first wedge position W1 to the
second wedge position W2
[0485] Referring to FIGS. 84 and 87, the locking mechanism 570
includes a rocker kicker 598 pivotally affixed therein. The rocker
kicker 598 is biasedly connected to the locking mechanism 570,
being held in a closed position by a pin 600. When the trigger 564
is actuated from the first trigger position TR1 to the second
trigger position TR2, the release 602 engages the pin 600,
releasing the rocker kicker 590.
[0486] The trigger 564 is released, allowing the trigger 564 to
move from the second trigger position TR2 to the first trigger
position TR1. To actuate the cutting mechanism, the trigger is
again moved from the first trigger position TR1 to the second
trigger position TR2, such that the rocker kicker 598 engages the
rocker 596, pivoting the rocker 596 from the first rocker position
R1 to the second rocker position. The rocker 596 slides the wedge
pusher 594 from the first position to the second position, moving
wedges 586 and 588 from the first wedge position W1 to the second
wedge position W2, such that, the tapered ends 590 and 592 compress
the cut off cams 582 and 584 together, cutting the cable. The
trigger 564 can then be released, releasing the crimped
fastener.
[0487] It is also contemplated that the system and medical device
of the present invention may be disposable or may be sterilized
after use and reused.
[0488] The methods and devices of the present invention may be used
in conjunction with any surgical procedure of the body. The repair,
reconstruction, augmentation, and securing of tissue or an implant
may be performed in connection with surgery of a joint, bone,
muscle, ligament, tendon, cartilage, capsule, organ, skin, nerve,
vessel, or other body part. For example, tissue may be repaired,
reconstructed, augmented, and secured following intervertebral disc
surgery, knee surgery, hip surgery, organ transplant surgery,
bariatric surgery, spinal surgery, anterior cruciate ligament (ACL)
surgery, tendon-ligament surgery, rotator cuff surgery, capsule
repair surgery, fractured bone surgery, pelvic fracture surgery,
avulsion fragment surgery, hernia repair surgery, and surgery of an
intrasubstance ligament tear, annulus fibrosis, fascia lata, flexor
tendons, etc. In one particular application, an anastomosis is
performed over a balloon and the methods and devices of the present
invention are used to repair the vessel.
[0489] Also, tissue may be repaired after an implant has been
inserted within the body. Such implant insertion procedures
include, but are not limited to, partial or total knee replacement
surgery, hip replacement surgery, bone fixation surgery, etc. The
implant may be an organ, partial organ grafts, tissue graft
material (autogenic, allogenic, xenogenic, or synthetic), collagen,
a malleable implant like a sponge, mesh, bag/sac/pouch, collagen,
or gelatin, or a rigid implant made of metal, polymer, composite,
or ceramic. Other implants include biodegradable plates, porcine or
bovine patches, metallic fasteners, compliant bearings for one or
more compartments of the knee, nucleus pulposus prosthetic, stent,
tissue graft, tissue scaffold, biodegradable collagen scaffold, and
polymeric or other biocompatible scaffold. The scaffold may include
fetal cells, stem cells, embryonal cells, enzymes, and
proteins.
[0490] The present invention further provides flexible and rigid
fixation of tissue. Both rigid and flexible fixation of tissue
and/or an implant provides compression to enhance the healing
process of the tissue. A fractured bone, for example, requires the
bone to be realigned and rigidly stabilized over a period time for
proper healing. Also, bones may be flexibly secured to provide
flexible stabilization between two or more bones. Soft tissue, like
muscles, ligaments, tendons, skin, etc., may be flexibly or rigidly
fastened for proper healing. Flexible fixation and compression of
tissue may function as a temporary strut to allow motion as the
tissue heals. Furthermore, joints which include hard and soft
tissue may require both rigid and flexible fixation to enhance
healing and stabilize the range of motion of the joint. Flexible
fixation and compression of tissue near a joint may provide motion
in one or more desired planes. The fasteners described herein and
incorporated by reference provide for both rigid and flexible
fixation.
[0491] It is contemplated that the devices and methods of the
present invention be applied using minimally invasive incisions and
techniques to preserve muscles, tendons, ligaments, bones, nerves,
and blood vessels. A small incision(s) may be made adjacent the
damaged tissue area to be repaired, and a tube, delivery catheter,
sheath, cannula, or expandable cannula may be used to perform the
methods of the present invention. U.S. Pat. No. 5,320,611 entitled,
Expandable Cannula Having Longitudinal Wire and Method of Use,
discloses cannulas for surgical and medical use expandable along
their entire lengths. The cannulas are inserted through tissue when
in an unexpanded condition and with a small diameter. The cannulas
are then expanded radially outwardly to give a full-size instrument
passage. Expansion of the cannulas occurs against the viscoelastic
resistance of the surrounding tissue. The expandable cannulas do
not require a full depth incision, or at most require only a
needle-size entrance opening.
[0492] Also, U.S. Pat. Nos. 5,674,240; 5,961,499; and 6,338,730
disclose cannulas for surgical and medical use expandable along
their entire lengths. The cannula has a pointed end portion and
includes wires having cores which are enclosed by jackets. The
jackets are integrally formed as one piece with a sheath of the
cannula. The cannula may be expanded by inserting members or by
fluid pressure. The cannula is advantageously utilized to expand a
vessel, such as a blood vessel. An expandable chamber may be
provided at the distal end of the cannula. The above mentioned
patents are hereby incorporated by reference.
[0493] In addition to using a cannula with the methods of the
present invention, an introducer may be utilized to position
fasteners at a specific location within the body. U.S. Pat. No.
5,948,002 entitled Apparatus and Method for Use in Positioning a
Suture Anchor, discloses devices for controlling the placement
depth of a fastener. Also, U.S. Patent Application Publication No.
2003/0181800 discloses methods of securing body tissue with a
robotic mechanism. The above-mentioned patent and application are
hereby incorporated by reference. Another introducer or cannula
which may be used with the present invention is the VersaStep.RTM.
System by Tyco.RTM. Healthcare.
[0494] The present invention may also be utilized with minimally
invasive surgery techniques disclosed in U.S. Patent Application
Publication No. 2003/0181800 and U.S. Pat. Nos. 6,702,821 and
6,770,078. These patent documents disclose, inter alia, apparatus
and methods for minimally invasive joint replacement. The femoral,
tibial, and/or patellar components of a knee replacement may be
fastened or locked to each other and to adjacent tissue using
fasteners disclosed herein and incorporated by reference.
Furthermore, the methods and devices of the present invention may
be utilized for repairing, reconstructing, augmenting, and securing
tissue or implants during and "on the way out" of a knee
replacement procedure. For example, the anterior cruciate ligament
and other ligaments may be repaired or reconstructed; quadriceps
mechanisms and other muscles may be repaired. The patent documents
mentioned above are hereby incorporated by reference.
[0495] In addition, intramedullary fracture fixation and comminuted
fracture fixation may be achieved with the devices and methods of
the present invention. For example, a plate or rod may be
positioned within or against the fractured bone. A fastener may be
driven through or about the bone and locked onto the plate, rod, or
another fastener.
[0496] It is further contemplated that the present invention may be
used in conjunction with the devices and methods disclosed in U.S.
Pat. Nos. 5,329,846 entitled, Tissue Press and System, and
5,269,785 entitled, Apparatus and Method for Tissue Removal. For
example, an implant secured within the body using the present
invention may include tissue harvested, configured, and implanted
as described in the patents. The above-mentioned patents are hereby
incorporated by reference.
[0497] Furthermore, it is contemplated that the methods of the
present invention may be performed under indirect visualization,
such as endoscopic guidance, computer assisted navigation, magnetic
resonance imaging, CT scan, ultrasound, fluoroscopy, X-ray, or
other suitable visualization technique. The implants, fasteners,
fastener assemblies, and sutures of the present invention may
include a radiopaque material for enhancing indirect visualization.
The use of these visualization means along with minimally invasive
surgery techniques permits physicians to accurately and rapidly
repair, reconstruct, augment, and secure tissue or an implant
within the body. U.S. Pat. Nos. 5,329,924; 5,349,956; and 5,542,423
disclose apparatus and methods for use in medical imaging. Also,
the present invention may be performed using robotics, such as
haptic arms or similar apparatus. The above-mentioned patents are
hereby incorporated by reference.
[0498] It will be appreciated by persons skilled in the art that
the present invention is not limited to what has been particularly
shown and described herein above. In addition, unless mention was
made above to the contrary, it should be noted that all of the
accompanying drawings are not to scale. A variety of modifications
and variations are possible in light of the above teachings without
departing from the scope and spirit of the invention. All
references cited herein are expressly incorporated by reference in
their entirety.
[0499] While exemplary embodiments have been set forth above for
the purpose of disclosure, modifications of the disclosed
embodiments as well as other embodiments thereof may occur to those
skilled in the art. Accordingly, it is to be understood that the
disclosure is not limited to the above precise embodiments and that
changes may be made without departing from the scope. Likewise, it
is to be understood that it is not necessary to meet any or all of
the stated advantages or objects disclosed herein to fall within
the scope of the disclosure, since inherent and/or unforeseen
advantages may exist even though they may not have been explicitly
discussed herein.
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