U.S. patent application number 13/324401 was filed with the patent office on 2012-04-12 for devices for disc herniation repair and methods of use.
This patent application is currently assigned to Anova Corporation. Invention is credited to Bret A. Ferree.
Application Number | 20120089162 13/324401 |
Document ID | / |
Family ID | 38822872 |
Filed Date | 2012-04-12 |
United States Patent
Application |
20120089162 |
Kind Code |
A1 |
Ferree; Bret A. |
April 12, 2012 |
DEVICES FOR DISC HERNIATION REPAIR AND METHODS OF USE
Abstract
Devices and methods for fixing defects in the anulus fibrosus
(vertebral disc) of a patient are described. The devices a mesh
patch; first, second, third, and fourth sutures; and first, second,
third, and fourth anchors. Each anchor has a first portion adapted
for insertion into a bone and a second portion having an opening.
The sutures are disposed through the openings of the anchors. The
first portions of the first and second anchors are inserted into a
cranial vertebra. The first portions of the third and fourth
anchors are inserted into a caudal vertebra. The mesh patch is
positioned adjacent the defect. An end of first suture can be
attached to an end of the third suture. An end of the second suture
can be attached to an end of the fourth suture. The other ends of
each of the first, second, third, and fourth sutures can then be
anchored.
Inventors: |
Ferree; Bret A.;
(Cincinnati, OH) |
Assignee: |
Anova Corporation
|
Family ID: |
38822872 |
Appl. No.: |
13/324401 |
Filed: |
December 13, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11811751 |
Jun 12, 2007 |
8075619 |
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13324401 |
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60813232 |
Jun 13, 2006 |
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60847649 |
Sep 26, 2006 |
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Current U.S.
Class: |
606/151 |
Current CPC
Class: |
A61B 17/0485 20130101;
A61F 2002/30156 20130101; A61F 2230/0069 20130101; A61F 2/442
20130101; A61F 2002/30677 20130101; A61F 2002/4435 20130101; A61B
17/842 20130101; A61B 2017/0414 20130101; A61B 2017/0496 20130101;
A61F 2210/0004 20130101; A61B 17/0401 20130101; A61F 2002/30125
20130101; A61F 2002/30235 20130101; A61B 17/0487 20130101; A61F
2002/4495 20130101; A61B 17/06061 20130101; A61F 2230/0008
20130101; A61F 2310/00365 20130101; A61F 2230/0023 20130101; A61F
2002/30062 20130101; A61F 2002/30772 20130101; A61F 2002/3085
20130101 |
Class at
Publication: |
606/151 |
International
Class: |
A61B 17/03 20060101
A61B017/03 |
Claims
1. A device for fixing a defect in the anulus fibrosus of a
patient, comprising: a body adapted for insertion into the defect;
a mesh patch; first and second sutures, each having a first end and
a second end, wherein the first end is adapted for coupling to the
mesh patch; and first and second anchors, each having a first
portion adapted for insertion into a bone and a second portion
having an opening, wherein the opening of the first anchor is
adapted to receive the first suture and the opening of the second
anchor is adapted to receive the second suture.
2. The device of claim 1, wherein the body is made from a material
selected from the group consisting of cells, extracellular matrix,
and cytokines.
3. The device of claim 2, wherein the cells are selected from a
group consisting of mesenchymal stems cells, fibroblasts,
fibrocytes, cartilage cells, cells harvested from the annulus
fibrosus, cells harvested from the nucleus pulposus, autograft
cells, allograft cells, and xenograft cells.
4. The device of claim 3, wherein the cells are prepared using
tissue culture methods.
5. The device of claim 2, wherein the extracellular matrix is
selected from the group consisting of collagen scaffolds, autograft
scaffolds, allograft scaffolds, and xenograft scaffolds.
6. The device of claim 2, wherein the cytokines are selected from
the group consisting of bone morphogenic proteins, recombinant
growth hormone, vascular endothelial growth factor, platelet
derived growth factor, transforming growth factor-beta,
fibroblastic growth factor, insulin-like growth factor, granulocyte
colony stimulating factor, macrophage colony stimulating factor,
and epidermal growth factor.
7. The device of claim 6, wherein the bone morphogenic protein is
selected from the group consisting of BMP1, BMP2, BMP3, BMP4, BMP5,
BMP6, BMP7, BMP8, BMP9, BMP10, BMP11, BMPI2, BMP13, BMP14, BMP15,
BMP16, BMP17, BMP18, BMP19, and BMP20.
8. The device of claim 6, wherein the Platelet derived growth
factor is selected from the group consisting of rhPDGF-AA and
rhPDGF-BB.
9. The device of claim 6, wherein the fibroblastic growth factor is
selected from the group consisting of rhaFGF and rhbFGF.
10. The device of claim 6, wherein the granulocyte colony
stimulating factor is selected from the group consisting of
rhGM-CSF and rhG-CSF.
11. The device of claim 1, wherein the body is soaked in a solution
of BMP.
12. The device of claim 1, wherein the body contains BMP in a dose
of about 0.1 micrograms to about 30 mg.
13. The device of claim 1, wherein the body contains BMP in a dose
of at least about 0.1 micrograms.
14. The device of claim 1, wherein the body is a collagen
sponge.
15. The device of claim 1, wherein the body is made from a natural
polymer.
16. The device of claim 15, wherein the natural polymer is selected
from the group consisting of collagen, hyaluronans, chitosan,
alignate, and other animal or plant-derived polysaccharides.
17. The device of claim 1, wherein the body is made from a
synthetic polymer.
18. The device of claim 17, wherein the synthetic polymer is
selected from the group consisting of poly(alpha-hydroxy acids),
polyanhydrides, polyphosphazenes, polypropylene fumarate,
polyethylene glycol-PLA, poloxamers, polyphosphate polymers, and
their copolymers.
19. The device of claim 18, wherein poly(alpha-hydroxy acids) is
selected from the group consisting of polylactide, polyglycolide,
and their copolymers.
20. The device of claim 1, wherein the body is made from a
composite of a natural and synthetic material.
21. The device of claim 1, wherein the body is a tubular body
having a proximal end, a distal end, and a lumen therethrough.
22. The device of claim 1, wherein the body is a cylindrical body
having a proximal end, a distal end, and a lumen therethrough.
23. The device of claim 1, wherein the body comprises pores.
24. The device of claim 1, further comprising an additional porous
material adapted for insertion into the defect.
25. The device of claim 24, wherein the additional porous material
is a collagen sponge.
26. The device of claim 21, wherein the tubular body further
comprises a porous barrier disposed at any of the proximal opening,
distal opening, or within the lumen of the tubular body.
27. The device of claim 21, wherein the tubular body further
comprises threads disposed on an outer surface of the tubular
body.
28. The device of claim 1, wherein the body is triangular in shape
and has a proximal end, a distal end, and a lumen therethrough.
29. The device of claim 1, wherein the body is elliptical in shape
and has a proximal end, a distal end, and a lumen therethrough.
30. The device of claim 1, wherein the body is coupled to the mesh
patch.
31. The device of claim 27, wherein the body is coupled to the mesh
patch.
32. The device of claim 1, further comprising: third and fourth
sutures, each having a first end and a second end, wherein the
first end is adapted for coupling to the mesh patch; and third and
fourth anchors, each having a first portion adapted for insertion
into a bone and a second portion having an opening, wherein the
opening of the third anchor is adapted to receive the third suture
and the opening of the fourth anchor is adapted to receive the
fourth suture.
33. The device of claim 1, wherein the first and second sutures are
attached to the mesh patch by welding the first ends of the first
and second sutures to the mesh patch.
34. The device of claim 1, wherein at least one of the first and
second sutures further comprise a first end with an enlarged
surface area adapted for coupling to the mesh patch.
35. The device of claim 34, wherein a longest width of the enlarged
surface area is longer than a diameter of the suture.
36. The device of claim 32, wherein at least one of the third and
fourth sutures further comprise a first end with an enlarged
surface area adapted for coupling to the mesh patch.
37. The device of claim. 1, further comprising an anti-adhesion
cover adapted to be connected to the mesh patch.
38. The device of claim 1, further comprising a support structure
having a body and first and second opening adapted to receive the
first and second sutures, respectively.
39. The device of claim 1, wherein the first and second sutures are
slideably disposed within the openings of the first and second
anchors, respectively.
40. The device of claim 1, wherein the first and second sutures are
fixedly attached to the first and second anchors, respectively.
41. The device of claim 1, wherein the mesh patch is in the form of
a shape selected from the group consisting of a rectangle, a
square, a polygon, a circle, an ellipse, a oval, a planar disc, and
a triangle.
42. The device of claim 37, wherein the anti-adhesion patch is in
the form of a shape selected from the group consisting of a
rectangle, a square, a polygon, a circle, an ellipse, a oval, a
planar disc, and a triangle.
43. The device of claim 1, wherein the mesh patch comprises four
corners and wherein the suture assembly is attached to each of the
four corners of the mesh patch.
44. The device of claim 1, wherein the first and second anchors are
screws.
45. The device of claim 32, wherein the third and fourth anchors
are screws.
46. The device of claim 1, wherein the first ends of the first and
second sutures further comprise a transverse element adapted to
anchor the first ends of the first and second sutures to the mesh
patch.
47.-179. (canceled)
Description
RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application Ser. Nos. 60/813,232, entitled "Devices for Disc
Herniation Repair and Methods of Use", filed Jun. 13, 2006, and
60/847,649, entitled "Anulus Repair Device," filed Sep. 26, 2006,
all of which are hereby expressly incorporated by reference in
their entirety.
BACKGROUND
[0002] The human intervertebral disc is an oval to kidney
bean-shaped structure of variable size depending on the location in
the spine. The outer portion of the disc is known as the anulus
fibrosus (AF). The anulus fibrosus is formed of approximately 10 to
60 fibrous bands or layers. The fibers in the bands alternate their
direction of orientation by about 30 degrees between each band. The
orientation serves to control vertebral motion (one half of the
bands tighten to check motion when the vertebra above or below the
disc are turned in either direction).
[0003] The anulus fibrosus contains the nucleus pulposus (NP). The
nucleus pulposus serves to transmit and dampen axial loads. A high
water content (approximately 70-80%) assists the nucleus in this
function. The water content has a diurnal variation. The nucleus
imbibes water while a person lies recumbent. Nuclear material
removed from the body and placed into water will imbibe water
swelling to several times its normal size. Activity squeezes fluid
from the disc. The nucleus comprises roughly 50% of the entire
disc. The nucleus contains cells (chondrocytes and fibrocytes) and
proteoglycans (chondroitin sulfate and keratin sulfate). The cell
density in the nucleus is on the order of 4,000 cells per
microliter.
[0004] The intervertebral disc changes or "degenerates" with age.
As a person ages, the water content of the disc falls from
approximately 85% at birth to approximately 70% in the elderly. The
ratio of chondroitin sulfate to keratin sulfate decreases with age,
while the ratio of chondroitin 6 sulfate to chondroitin 4 sulfate
increases with age. The distinction between the anulus and the
nucleus decreases with age. Generally disc degeneration is
painless.
[0005] Premature or accelerated disc degeneration is known as
degenerative disc disease. A large portion of patients suffering
from chronic low back pain are thought to have this condition. As
the disc degenerates, the nucleus and anulus functions are
compromised. The nucleus becomes thinner and less able to handle
compression loads. The anulus fibers become redundant as the
nucleus shrinks. The redundant annular fibers are less effective in
controlling vertebral motion. This disc pathology can result in: 1)
bulging of the anulus into the spinal cord or nerves; 2) narrowing
of the space between the vertebra where the nerves exit; 3) tears
of the anulus as abnormal loads are transmitted to the anulus and
the anulus is subjected to excessive motion between vertebra; and
4) disc herniation or extrusion of the nucleus through complete
anular tears.
[0006] Current surgical treatments for disc degeneration are
destructive. One group of procedures, which includes lumbar
discectomy, removes the nucleus or a portion of the nucleus. A
second group of procedures destroy nuclear material. This group
includes Chymopapin (an enzyme) injection, laser discectomy, and
thermal therapy (heat treatment to denature proteins). The first
two groups of procedures compromise the treated disc. A third
group, which includes spinal fusion procedures, either remove the
disc or the disc's function by connecting two or more vertebra
together with bone. Fusion procedures transmit additional stress to
the adjacent discs, which results in premature disc degeneration of
the adjacent discs. These destructive procedures lead to
acceleration of disc degeneration.
[0007] Prosthetic disc replacement offers many advantages. The
prosthetic disc attempts to eliminate a patient's pain while
preserving the disc's function. Current prosthetic disc implants
either replace the nucleus or replace both the nucleus and the
anulus. Both types of current procedures remove the degenerated
disc component to allow room for the prosthetic component. Although
the use of resilient materials has been proposed, the need remains
for further improvements in the way in which prosthetic components
are incorporated into the disc space to ensure strength and
longevity. Such improvements are necessary, since the prosthesis
may be subjected to 100,000,000 compression cycles over the life of
the implant.
[0008] Current nucleus replacements (NRs) may cause lower back pain
if too much pressure is applied to the anulus fibrosus. As
discussed in co-pending U.S. patent application Ser. No. 10/407,554
and U.S. Pat. No. 6,878,167, the content of each being expressly
incorporated herein by reference in their entirety, the posterior
portion of the anulus fibrosus has abundant pain fibers.
[0009] Herniated nucleus pulposus (HNP) occurs from tears in the
anulus fibrosus. The herniated nucleus pulposus often applies
pressure on the nerves or spinal cord. Compressed nerves cause back
and leg or arm pain. Although a patient's symptoms result primarily
from pressure by the nucleus pulposus, the primary pathology lies
in the anulus fibrosus.
[0010] Surgery for herniated nucleus pulposus, known as microlumbar
discectomy (MLD), only addresses the nucleus pulposus. The opening
in the anulus fibrosus is enlarged during surgery, further
weakening the anulus fibrosus. Surgeons also remove generous
amounts of the nucleus pulposus to reduce the risk of extruding
additional pieces of nucleus pulposus through the defect in the
anulus fibrosus. Although microlumbar discectomy decreases or
eliminates a patient's leg or arm pain, the procedure damages
weakened discs.
SUMMARY
[0011] The subject invention resides in methods and apparatus for
treating disc herniation, which may be defined as the escape of
nucleus pulposus (NP) through a void or defect in the anulus
fibrosus (AF) of a spinal disc situated between upper and lower
vertebra. The invention is particularly well suited to the
minimization and prevention of recurrent disc herniation, in which
case the defect is a hole or void which remains in the anulus
fibrosus following disc operations involving partial
discectomy.
[0012] The subject invention also resides in methods and apparatus
for treating disc herniation, which may be defined as the escape of
nucleus pulposus (NP) through a void or defect in the anulus
fibrosus (AF) of a spinal disc situated between upper and lower
vertebra. The invention is particularly well suited to the
minimization and prevention of recurrent disc herniation, in which
case the defect is a hole or void which remains in the anulus
fibrosus following disc operations involving partial discectomy.
The invention may be used to retain material that has been added to
the disc. For example, the invention may be used to retain nucleus
replacement devices, bone graft material, or other prosthetic
devices.
[0013] Materials could be placed into the defective region or
regions of the Anulus Fibrosus (AF) to promote healing across the
entire thickness of the defective region of the AF. For example, a
clot of blood marrow aspirated from the vertebrae or other bone in
the skeleton could be injected into and over the defective region
of the AF. The marrow aspirate could also be injected into and over
the in-growth mesh patch or sheet. The cells of the marrow aspirate
could be concentrated using such systems as the "Harvest Select"
system by DePuy spine. Alternative materials, such as fibrin glue
("Tisseal", Baxter), or other bio-glue could be inserted into
and/or over the defective region of the AF. Portions of the
vertebrae near the defective region of the AF, could be perforated,
for example with a 1-2 mm diameter drill bit or bur, to improve the
blood supply to the relatively avascular AF. The holes are
preferably drilled through the vertebral endplates (VEPs) near the
defective region of the AF.
[0014] The invention may seal the defective region of the AF to
promote healing on one side of the device and to prevent
anti-adhesion materials from entering the defective region of the
AF. Additionally, anti-adhesion materials such Coseal (Baxter)
could be injected over the device.
[0015] In one embodiment, the invention is a device for fixing a
defect in the anulus fibrosus of a patient. The device includes a
body adapted for insertion into the defect, a mesh patch, first and
second sutures, and first and second anchors. Each of the first and
second sutures have a first end and a second end, the first end
adapted for coupling to the mesh patch. The first and second
anchors each have a first portion adapted for insertion into a bone
and a second portion having an opening. The opening of the first
anchor is adapted to receive the first suture and the opening of
the second anchor is adapted to receive the second suture. The
device may optionally include third and fourth anchors similar to
the first and second anchors described above.
[0016] In another embodiment, the invention includes a method of
treating a defect in a vertebral disc of a patient using the device
described above. The method includes providing a body adapted for
insertion into the defect, a mesh patch, first and second sutures,
and first and second anchors. Each of the first and second sutures
has a first end and a second end, the first end capable of being
coupled to the mesh patch. The first and second anchors each have a
first portion adapted to be inserted into a bone and a second
portion having an opening. The first suture is threaded through the
opening of the first anchor and the second suture is threaded
through the opening of the second anchor. The body is inserted into
the defect. The first portion of the first anchor is inserted into
a vertebra cranial to the vertebral disc and the first portion of
the second anchor is inserted into a vertebra caudal to the
vertebral disc. The first ends of the first and second sutures are
attached to the mesh patch. The mesh patch is positioned then
adjacent the defect by pulling on the second end of the first and
second sutures.
[0017] In another embodiment, the invention includes a method of
treating a defect in a vertebral disc of a patient. A body adapted
for insertion into the defect, a mesh patch coupled to the body,
first and second sutures, and first and second anchors are
provided. Each of the first and second sutures have a first end and
a second end, wherein the first end is capable of being coupled to
the mesh patch. Each of the first and second anchors have a first
portion adapted to be inserted into a bone and a second portion
having an opening. The first suture is threaded through the opening
of the first anchor and the second suture is threaded through the
opening of the second anchor. The body is inserted into the defect
such that the mesh patch is positioned adjacent the defect. The
first portion of the first anchor is inserted into a vertebra
cranial to the vertebral disc and the first portion of the second
anchor is inserted into a vertebra caudal to the vertebral disc.
The first ends of the first and second sutures are attached to the
mesh patch. The second ends of the first and'second sutures are
then pulled or otherwise put under tension.
[0018] In yet another embodiment, the invention also includes a
device for fixing a defect in the anulus fibrosus of a patient. The
device includes a mesh patch, a first suture assembly, and a second
suture assembly. The first suture assembly includes a first anchor
and a first suture. The first anchor has a first portion adapted to
be inserted into a bone and a second portion having an opening
therethrough. The first suture has a first end portion that is
visibly distinguishable from a second end portion. The first suture
is disposed through the hole in the first anchor. The second suture
assembly includes a second anchor and a second suture. The second
anchor has a first portion adapted to be inserted into a bone and a
second portion having an opening therethrough. The second suture
has a first end portion that is visibly distinguishable from a
second end portion. The second suture is disposed through the hole
in the second anchor.
[0019] In another embodiment, the invention also includes a method
for treating a defect in a vertebral disc of a patient. The steps
include providing a device including a mesh patch, a first suture
assembly, and a second suture assembly. The first suture assembly
includes a first anchor and a first suture. The first anchor has a
first portion adapted to be inserted into a bone and a second
portion having an opening therethrough. The first suture has a
first end portion that is visibly distinguishable from a second end
portion and is disposed through the hole in the first anchor. The
second suture assembly includes a second anchor and a second
suture. The second anchor has a first portion adapted to be
inserted into a bone and a second portion having an opening
therethrough. The second suture has a first end portion that is
visibly distinguishable from a second end portion and is disposed
through the hole in the second anchor. The first portion of the
first anchor is inserted into a vertebra cranial to the vertebral
disc. The first portion of the second anchor is inserted into a
vertebra caudal to the vertebral disc. A first end of the first
suture and a first end of the second suture are attached to the
mesh patch. The mesh patch is positioned adjacent the defect by
pulling on the second ends of the first and second sutures. The
second end of the first suture and a second end of the second
suture are then anchored.
[0020] In another embodiment, the invention includes a device for
fixing a defect in the anulus fibrosus of a patient. The device
includes a mesh patch; first, second, third, and fourth sutures;
and first, second, third, and fourth anchors. The first, second,
third, and fourth sutures each have a first end portion that is
visibly distinguishable from a second end portion. The first,
second, third, and fourth anchors each have a first portion adapted
for insertion into a bone and a second portion having an opening.
The openings of the first, second, third, and fourth anchors are
adapted to receive the first, second, third, and fourth sutures,
respectively.
[0021] In another embodiment, the invention includes a method of
treating a defect in a vertebral disc of a patient. A device is
provided that includes a mesh patch; first, second, third, and
fourth sutures; and first, second, third, and fourth anchors. The
first, second, third, and fourth sutures each have a first end that
is visibly distinguishable from a second end. The first, second,
third, and fourth anchors each have a first portion adapted for
insertion into a bone and a second portion having an opening. The
first, second, third, and fourth sutures are disposed through the
openings of the first, second, third, and fourth anchors,
respectively. The first portions of the first and second anchors
are inserted into a vertebra cranial to the vertebral disc. The
first portions of the third and fourth anchors are inserted into a
vertebra caudal to the vertebral disc. A first end of the first
suture and a first end of the third suture are attached to the mesh
patch. A first end of the second suture and a first end of the
fourth suture are attached to the mesh patch. The mesh patch is
then positioned adjacent the defect by pulling on the second end
portions of the first, second, third, and fourth sutures. A second
end of the first, second, third, and fourth sutures are then
anchored.
[0022] In yet another embodiment, the invention includes a method
of treating a defect in a vertebral disc of a patient. A device is
provided that includes a mesh patch; first, second, third, and
fourth sutures; and first, second, third, and fourth anchors. The
first, second, third, and fourth sutures each have a first end and
a second end. The first, second, third, and fourth anchors each
have a first portion adapted for insertion into a bone and a second
portion having an opening. The first, second, third, and fourth
sutures are disposed through the openings of the first, second,
third, and fourth anchors, respectively. The first portions of the
first and second anchors are inserted into a vertebra cranial to
the vertebral disc. The first portions of the third and fourth
anchors are inserted into a vertebra caudal to the vertebral disc.
The mesh patch is positioned adjacent the defect. A first end of
the first suture is attached to a first end of the third suture. A
first end of the second suture is attached to a first end of the
fourth suture. Second ends of each of the first, second, third, and
fourth sutures are then anchored.
[0023] The attaching/anchoring in any of the methods described
above can be accomplished in many ways. The first and/or second
ends of the various sutures could be anchored either by attaching
the end to another suture or by attaching the end to the mesh
patch. For example, the second end of the first and second sutures
could be anchored (e.g., through welding or crimping) to the second
ends of the third and fourth sutures, respectively. The second end
of the first suture could similarly be anchored to the second end
of the second suture. The first or second ends of the sutures could
also be anchored by attaching the ends to the mesh patch.
BRIEF DESCRIPTION OF THE FIGURES
[0024] FIG. 1A is a posterior view of an intervertebral disc and
with a device (or body) visible through the aperture.
[0025] FIG. 1B is an axial cross section of an intervertebral disc
and the embodiment of the invention drawn in FIG. 1A.
[0026] FIG. 1C is an axial cross section of the intervertebral disc
with the device (or body) combined with a patch coupled to the
outside of the AF to help prevent extrusion of the NP past the
outer layer of the AF.
[0027] FIG. 2A is an oblique view of a tubular body adapted for
insertion into an aperture in a disc.
[0028] FIG. 2B is an oblique view of a tubular body made of porous
material.
[0029] FIG. 2C is a posterior view of a disc, a tubular body, and a
second porous device inserted into an aperture of a disc.
[0030] FIG. 2D is an axial cross section of a disc , the
embodiments of the invention drawn in FIG. 2C, and a mesh
patch.
[0031] FIG. 3A is an oblique view of an alternative tubular body
having a porous barrier that crosses the lumen of the tubular
body.
[0032] FIG. 3B is an oblique view of an alternative embodiment of
the invention drawn in FIG. 3A having external threads.
[0033] FIG. 3C is an oblique view of an alternative embodiment of
the invention drawn in FIG. 3A having a triangular cross section
and a triangular-shaped lumen passing therethrough.
[0034] FIG. 3D is an oblique view of an alternative embodiment of
the invention drawn in FIG. 3C having an oval cross section and an
oval-shaped lumen passing therethrough.
[0035] FIG. 3E is a posterior view of the disc with a tubular body
inserted into the disc.
[0036] FIG. 3F is an axial cross section of the disc and the
embodiment of the invention drawn in FIG. 3E, which illustrates a
tubular body with a porous barrier forming a tight seal with the
surrounding the anulus fibrosus of the disc.
[0037] FIG. 4A is a lateral view of a tubular body with external
threads that is connected or coupled to a mesh patch.
[0038] FIG. 4B is a posterior view of the embodiment of the
invention drawn in FIG. 4A, showing the face of the porous mesh
patch.
[0039] FIG. 4C is an axial cross section of a disc and the
embodiment of the invention drawn in FIG. 4A.
[0040] FIG. 4D is a posterior view of a sagittal cross section of
the spine and the embodiment of the invention drawn in FIG. 4C.
[0041] FIG. 4E is a posterior view of a sagittal cross section of
the spine and a device attached to the spine with suture
anchors.
[0042] FIG. 5A is a posterior view of a coronal cross section of
the spine with two anchors, with associate sutures, inserted into
each of the cranial and caudal vertebrae surrounding a disc having
a defect.
[0043] FIG. 5B is an exploded lateral view of sutures and anchors
drawn in FIG. 5A.
[0044] FIG. 5C is a posterior view of a mesh patch connected to an
anti-adhesion patch through a suture.
[0045] FIG. 5D is a lateral view of suture managing tool component
of the invention.
[0046] FIG. 5E is a view of the end of the embodiment of the
invention drawn in FIG. 5D.
[0047] FIG. 5F is a posterior view of a portion of a patient's
back, a surgical wound and the embodiments of the invention drawn
in FIGS. 5A to 5E.
[0048] FIG. 5G is a posterior view of the embodiment of the
invention drawn in FIG. 5F with the medial end of the fixation
suture from the "10 o'clock" anchor welded or otherwise fastened to
the medial end of the suture from the "4 o'clock" anchor.
[0049] FIG. 5H is a posterior view of the embodiment of the
invention drawn in FIG. 5G with the medial ends of the "2 o'clock"
and the "8 o'clock" fixation sutures welded together.
[0050] FIG. 5I is a posterior view of the embodiment of the
invention drawn in FIG. 5H with the lateral ends of various sutures
welded together.
[0051] FIG. 5J is a posterior view a coronal cross section of the
spine and the embodiment of the invention drawn in FIG. 5I with the
suture management tools removed and an anti-adhesion cover
connected through a suture.
[0052] FIG. 5K is a posterior view of a coronal cross section of
the spine showing the anti-adhesion cover attached by a welded
suture.
[0053] FIG. 5L is a posterior view of an alternative embodiment of
a suture holding tool having components that telescope within each
other.
[0054] FIG. 6A illustrates a mesh component having a tubular shape
with an associated anti-adhesion component.
[0055] FIG. 6B is a posterior view of the embodiment of the
invention drawn in FIG. 6A with the lateral ends of the sutures
from the cranial pair of anchors passed between the layers of
mesh.
[0056] FIG. 6C is a lateral view of the embodiment of the invention
drawn in FIG. 6B, which depicts lateral ends of sutures sandwiched
between the layers of mesh and the connecting suture stitched
through both layers of the mesh device.
[0057] FIG. 6D is a posterior view of the embodiment of the
invention drawn in FIG. 6B with the lateral ends of the sutures
from the caudal pair of anchors welded to the lateral ends of the
sutures from the cranial pair of anchors.
[0058] FIG. 6E is a lateral view of the embodiment of the invention
drawn in FIG. 6D, which depicts lateral ends of sutures sandwiched
between the layers of mesh of the device.
[0059] FIG. 6F is a posterior view of the embodiment of the
invention drawn in FIG. 6D with the mesh layers "spot welded" just
medial to the vertical arms of the fixation suture.
[0060] FIG. 6G is a lateral view of the embodiment of the invention
drawn in FIG. 6F, which depicts lateral ends of sutures sandwiched
between the layers of mesh of device.
[0061] FIG. 6H is a posterior view of the embodiment of the
invention drawn in FIG. 6G with the medial ends of the fixation
sutures welded together.
[0062] FIG. 6I is a lateral view of the embodiment of the invention
drawn in FIG. 6H, which depicts the lateral ends of sutures
sandwiched between the layers of mesh of the device.
[0063] FIG. 6J is a posterior view of an alternative embodiment of
the invention drawn in FIG. 6H.
[0064] FIG. 7A is a posterior view of a mesh device having enlarged
ends.
[0065] FIG. 7B is a posterior view of a mesh device where the
enlarged ends extend beyond the cranial and the caudal pair of
anchors.
[0066] FIG. 8A is a posterior view of a weldable fixation component
(star shaped) fastened to the mesh component.
[0067] FIG. 8B is a posterior view a weldable fixation component
where mesh is fastened to only a portion of the fixation
component.
[0068] FIG. 8C is a lateral view of the embodiment of the invention
drawn in FIG. 8B.
[0069] FIG. 8D is an end view of the embodiment of the invention
drawn in FIG. 8C.
[0070] FIG. 8E is a posterior view a weldable fixation component
attached to a mesh patch where the sutures were welded to the
diagonal arms of the fixation component.
[0071] FIG. 8F is a posterior view of the embodiment of the
invention drawn in FIG. 8E.
[0072] FIG. 8G is a posterior view of the embodiment of the
invention drawn in FIG. 8F with the lateral ends of the fixation
sutures welded together.
[0073] FIG. 8H is a lateral view of an alternative embodiment of an
anti-adhesion cover.
[0074] FIG. 8I is a posterior view of the embodiments of the
invention drawn in FIGS. 8G and 8H.
[0075] FIG. 9A is a posterior view of an alternative embodiment a
weldable fixation component with long diagonal arms.
[0076] FIG. 9B is a posterior view of the embodiments of the
invention drawn in FIGS. 5A and 9A.
[0077] FIG. 9C is a posterior view of the embodiment of the
invention drawn in FIG. 9B.
[0078] FIG. 9D is a posterior view of the embodiment of the
invention drawn in FIG. 9C, which shows the vertical arms of the
fixation sutures welded together.
[0079] FIG. 9E is a lateral view of the embodiment of the invention
drawn in FIG. 9D, which illustrates the vertical arms sitting
within recessed regions of the horizontal arms.
[0080] FIG. 10A is a posterior view of a mesh patch with a weldable
suture threaded therethrough.
[0081] FIG. 10B is a posterior view of the embodiments of the
invention drawn in FIG. 10A with two fixation sutures passed under
"purse string" suture.
[0082] FIG. 10C is a posterior view of the embodiment of the
invention drawn in FIG. 10B with two more sutures passed under the
"purse string."
[0083] FIG. 10D is a posterior view of the embodiment of the
invention drawn in FIG. 10C with the ends of the "purse string"
welded together.
[0084] FIG. 10E is a posterior view of the embodiment of the
invention drawn in FIG. 10D with the lateral ends of the fixation
sutures welded together.
[0085] FIG. 11 is a posterior view of an alternative mesh component
with a "purse string" or suture placed such that exposed stitches
are positioned closer to the center of the mesh.
[0086] FIG. 12A is a posterior view of an alternative embodiment a
mesh patch having two loops passed under a "purse string."
[0087] FIG. 12B is a posterior view of the alternative embodiment
of FIGS. 5A where the ends of the fixation sutures were passed
through the openings in the loops.
[0088] FIG. 12C is an exploded posterior view of the embodiment of
the invention drawn in FIG. 12B.
[0089] FIG. 12D is a posterior view of an alternative mesh patch
where the 1475 of FIG. 12A were replaced by devices with slit-like
ends.
[0090] FIG. 13 is an axial cross section of a disc, the thecal sac,
nerves, and the embodiment of the invention drawn in FIG. 5K.
[0091] FIG. 14 is an axial cross section of a disc, the thecal sac,
nerves, and the embodiment of the invention drawn in FIG. 5K, where
the device is used to treat a defect across a central portion of
the posterior aspect of the disc.
[0092] FIG. 15A is a posterior view of a portion of the spine where
fixation sutures are seen exiting the spinal canal lateral to the
thecal sac.
[0093] FIG. 15B is a posterior view of a coronal cross section of
the spine and the embodiment of the invention drawn in FIG.
15A.
[0094] FIG. 15C is a lateral view of a suture passing tool.
[0095] FIG. 15D is a lateral view of the suture tool drawn in FIG.
15C with the loop that passes through the tool advanced further out
the distal end of the tool.
[0096] FIG. 15E is a posterior view of a coronal cross section of
the spine, the embodiment of the invention drawn in FIG. 15B and
the suture passing tool.
[0097] FIG. 15F is an axial cross section of the disc, the
embodiment of the invention drawn in FIG. 15E and the suture
passing tool passed between the disc and the thecal sac.
[0098] FIG. 15G is a posterior view of a coronal cross section of
the spine, the embodiment of the invention drawn in FIGS. 5A and
5C, and the suture passing tool 1480.
[0099] FIG. 15H is an axial cross section of a disc and the
embodiment of the invention drawn in FIG. 15G.
[0100] FIG. 15I is a posterior view of a coronal cross section of
the spine and the embodiment of the invention drawn in FIG.
15G.
[0101] FIG. 15J is an axial cross section of a disc and the
embodiment of the invention drawn in FIG. 15I.
[0102] FIG. 15K is a posterior view of a coronal cross section of
the spine and the embodiment of the invention drawn in FIG. 15I
with the diagonal arms of the fixation sutures welded together from
the right side of the spinal canal.
[0103] FIG. 15L is a posterior view of a coronal cross section of
the spine and the embodiment of the invention drawn in FIG. 15K
with an anti-adhesion cover.
[0104] FIG. 16A is a posterior view of an alternative mesh patch
with a reinforcement band coursing through or over the mesh
patch.
[0105] FIG. 16B is a posterior view of the mesh patch of FIG. 16A
with the fixation sutures passing through the mesh and through the
central portion of the high tensile strength loop.
[0106] FIG. 17A is a posterior view of an alternative mesh patch
with reinforcing members or bands course through the mesh.
[0107] FIG. 17B is a posterior view of the alternative mesh patch
of FIG. 17A where sutures with enlarged ends of the fixation
members were placed through the openings in the reinforced regions
of the mesh.
[0108] FIG. 18A is a posterior view of an alternative mesh patch
having a closed loop as a reinforcement component.
[0109] FIG. 18B is a posterior view of the embodiment of the
invention drawn in FIG. 18A wherein fixation members have been
welded or otherwise attached to the strands of the reinforcement
component.
[0110] FIG. 19 is a posterior view of an alternative mesh patch
where the periphery of the mesh is reinforced with reinforcement
members.
[0111] FIG. 20 is a posterior view of an alternative mesh patch
where the reinforcement members have openings, and vertical,
horizontal, and diagonal components.
[0112] FIG. 21A is a lateral view of an alternative suture holding
device having two slots to receive sutures.
[0113] FIG. 21B is a view of the top of the embodiment of the
invention drawn in FIG. 21A,
[0114] FIG. 22A is a posterior view of an alternative weldable
component having slots that make the device more flexible in one
direction.
[0115] FIG. 22B is a lateral view of a portion of the embodiment of
the invention drawn in FIG. 22A.
[0116] FIG. 22C is a lateral view of the embodiment of the
invention drawn in FIG. 22B.
[0117] FIG. 22D is a lateral view of the embodiment of the
invention drawn in FIG. 22C.
[0118] FIG. 22E is posterior view of the embodiment of the
invention drawn in FIG. 22A and a mesh component.
[0119] FIG. 23A is a lateral view of an alternative suture holding
device having a base with posts having slots.
[0120] FIG. 23B is view of the top of the embodiment of the
invention drawn in FIG. 23A and portions of two sutures.
DETAILED DESCRIPTION
[0121] FIG. 1A is a posterior view of intervertebral disc 2 and an
alternative embodiment of the invention. Disc 2 has crescent shaped
aperture 4. The end of a novel device (or body) 7 is seen within
aperture 4. In one embodiment, body 7 does not fill the aperture.
The space 5 between body 7 and the AF allows fluids, cells, tissue
(including NP), or other materials to flow into and out of disc 2.
Extrusion of NP tissue may facilitate healing of the damaged AF.
The extruded NP provides cells and a diffusion pathway for oxygen
and nutrients. Body 7 could be made of materials that promote
healing of the damaged AF. For example, body 7 could be made of
cells, extracellular matrix, cytokines, and other therapeutic
substances. The cells could include mesenchymal stems cells,
fibroblasts, fibrocytes, cartilage cells, cells harvested from the
AF or the NP, or other autograft, allograft, or xenograft cells.
The cells could be expanded by tissue culture. The extracellular
matrix could include collagen scaffolds, and scaffolds made from
autograft, allograft, or xenograft tissues. The cytokines could.
include Bone Morphogenic Proteins (BMP1, BMP2, BMP3, BMP4, BMP5,
BMP6, BMP7, BMP8, BMP9, BMP10, BMP 11, BMP12, BMP13, BMP14, BMP 15,
BMP16, BMP 17, . . . BMP-n), Recombinant growth hormone (rhGH)
(Genetech, San Francisco, Calif.), Vascular endothelial growth
factor (rhVEGF) (Genetech, San Francisco, Calif.), Platelet derived
growth factor (rhPDGF-AA & rhPDGF-BB) (Chiron, Emeryville,
Calif. & Amgen, Thousand Oaks; Calif.), Transforming growth
factor-beta (rhTGF-Beta) (Oncogen Corp, Seattle, Wash., New England
Nuclear Boston, Mass., R&D Systems, Minneapolis, Minn., &
Amgen, Thousand Oaks, Calif.), Fibroblastic growth factor (rhaFGF
& rhbFGF) (Amgen, Thousand Oaks, Calif. & Chiron,
Emeryville, Calif.), Insulin-like growth factor (rhIGF-1) (UBI Lake
Placid, N.Y. & Amgen, Thousand Oaks, Calif.), Granulocyte
colony stimulating factor (rhGM-CSF, rhG-CSF) (Amgen, Thousand
Oaks, Calif.), Macrophage colony stimulating factor (rhM-CSF)
(Chiron, Emeryville, Calif.), and Epidermal growth factor (rhEGF)
(Chiron, Emeryville, Calif.).
[0122] For example, an absorbable collagen sponge (Integra Life
Sciences, Plainsboro, N.J.) could be soaked in a 1.5 mg rhBMP-2/ml
sterile saline solution (Medtronic Sofamor Danek, Memphis, Tenn.)
for about 15 minutes before inserting the BMP impregnated sponge
into the disc. Other doses of BMP are acceptable. For example,
doses from about 0.04 micrograms to about 32 mg of BMP,
alternatively from about 0.1 micrograms to about 30 mg of BMP,
alternatively from about 1.0 micrograms to about 25 mg of BMP,
alternatively from about 5.0 micrograms to about 20 mg of BMP,
could be used. Alternatively, at least about 0.04 micrograms of
BMP, alternatively at least about 0.1 micrograms, alternatively at
least about 0.5 micrograms, alternatively at least about 1.0
micrograms, alternatively at least about 5.0 micrograms,
alternatively at least about 10.0 micrograms, alternatively at
least about 50.0 micrograms, alternatively at least about 100
micrograms, alternatively at least about 500 micrograms,
alternatively at least about 1.0 mg, alternatively at least about
5.0 mg, alternatively at least about 10.0 mg, alternatively at
least about 15.0 mg, alternatively at least about 20.0 mg,
alternatively at least about 25.0 mg, alternatively at least about
30.0 mg, alternatively at least about 35.0 mg, alternatively at
least about 40.0 mg, could be used. Other synthetic and natural
carriers are acceptable, such as a polyactic/polyglycolic acid
sponge as mentioned in the parent app. Examples include natural
polymers of collagen, hyaluronans, chitosan, alignate, and other
animal or plant-derived polysaccharides. Examples of synthetic
polymers include poly(alpha-hydroxy acids) such as polylactide,
polyglycolide, and their copolymers, polyanhydrides,
polyphosphazenes, polypropylene fumarate, polyethylene
glycol-polylactic acid (PLA), poloxamers, and polyphosphate
polymers. Composites of natural materials, synthetic materials, or
natural and synthetic materials could also be used as carriers. For
example, composites of hyaluronan-impregnated PLA sponges,
collagen-PLG-alginate, and PLGA-gelatin could be used.
[0123] FIG. 1B is an axial cross section of intervertebral disc 2
and the embodiment of the invention drawn in FIG. 1A. NP 6 has
extruded between body 7 and the AF.
[0124] FIG. 1C is an axial cross section of intervertebral disc 2
with body 7 combined with a patch coupled to the outside of the AF
to help prevent extrusion of the NP past the outer layer of the AF.
The patch device is described in related U. S. Patent Application
Nos. 60/808,795, filed May 26, 2006, entitled "Fastening Assemblies
for Disc Herniation Repair and Methods of Use," 60/748,518, filed
Dec. 8, 2005, entitled "Cemented Sutures" and 60/738,833, filed
Nov. 21, 2005, entitled "Sub-PLL Annular Repair Methods and
Devices," all of which are hereby incorporated by reference in
their entirety. Mesh patch 10 prevents the NP from extruding beyond
the AF. NP that extrudes beyond the disc can damage nerves. Cross
sections of anti-adhesion cover 15 and sutures 11 can be seen
covering mesh patch 10. Mesh patch 10 may be used to contain body 7
that is positioned or placed into aperture of or defect 4 of the
AF.
[0125] FIG. 2A is an oblique view of an alternative embodiment of
the invention drawn in FIG. 1A. Tubular body 17 provides a
passageway or lumen 18 for NP material to pass into and/or through
an aperture in the AF. Tubular body 17 is preferably made of
resorbable materials. Suitable bio-resorbable materials include,
but are not limited to, polylactic acid (PLA), polyglycolic acid
(PGA), poly (ortho esters), poly(glycolide-co-trimethylene
carbonate), poly-L-lactide-co-6-caprolactone, polyanhydrides,
poly-n-dioxanone, and poly(PHB-hydroxyvaleric acid). Alternatively,
tubular body 17 could be made of non-absorbable materials. For
example, the device could be made of titanium or polyethylene.
[0126] FIG. 2B is an oblique view of an alternative embodiment of
the invention drawn in FIG. 2A. Tubular body 17 is made of porous
material. Passageway or lumen 18 still allows for NP material to
pass into and/or therethrough. Additionally, tubular body 17
contains pores 19 that also allow for NP material to pass into
and/or therethrough. For example, tubular body 17 could be made of
polypropylene, polyester, titanium, or other porous material.
[0127] FIG. 2C is a posterior view of a disc, the embodiment of
tubular body 17 drawn in FIGS. 2A and 2B, and a second porous
device 20 such as a collagen sponge (area of the drawing with
crossing diagonal lines). The embodiment of the device drawn in
FIGS. 2A and 2B and the second porous device are located in an
aperture within the disc. Lumen 18 provides a passageway for NP
tissue. The additional porous device 20 does not permit migration
of NP tissue. For example, the pores in the additional porous
device 20 may be too small to permit NP tissue to migrate through
the device.
[0128] FIG. 2D is an axial cross section of a disc 2, the
embodiments of the invention drawn in FIG. 2C, and a mesh patch.
Tubular body 17 and additional porous device 20 within the aperture
of the disc promote healing of the AF through the aperture. Mesh
patch 10 contains the NP tissue that passes through lumen 18 of
tubular device 17. Mesh patch also contains tubular body 17 and
additional porous device 20 within the aperture of disc 2 and
promotes tissue growth across the aperture.
[0129] FIG. 3A is an oblique view of an alternative embodiment of
the invention drawn in FIGS. 2A and 2B. Porous barrier 22 crosses
the lumen of tubular body 17. Porous barrier 22 may be located at
least one of a proximal end, distal end, and/or within the lumen
between the proximal and distal end of tubular body 17. Numerous
porous barriers may also be positioned at the ends of or within the
tubular body. Pores 19 of tubular body 17 and openings/pores 23a-c
in porous barrier 22 permit small pieces of NP to migrate from the
disc. Porous barrier 22 prevents large particles of NP tissue from
extruding from the disc. Large particles that extrude into the
spinal canal can impinge against the nerves. Small particles of
extruded NP are unlikely to compress the nerves. Porous barrier 22
may be a septum, filter, membrane, or other porous structure.
[0130] FIG. 3B is an oblique view of an alternative embodiment of
the invention drawn in FIG. 3A. Tubular body 17 additionally has
external threads 25.
[0131] FIG. 3C is an oblique view of an alternative embodiment of
the invention drawn in FIG. 3A. The angular body 27 is triangular
in cross section and has a triangular-shaped lumen 28 passing
therethrough.
[0132] FIG. 3D is an oblique view of an alternative embodiment of
the invention drawn in FIG. 3C. The body 37 is oval in cross
section and has an oval-shaped lumen 38 passing therethrough The
device may have alternative shapes such as a square, rectangle,
pentagon, hexagon, heptagon, octagon, or other polygon, ellipse,
etc.
[0133] FIG. 3E is a posterior view of the disc and the embodiment
of the invention drawn in FIG. 3B. Tubular body 17 has been
threaded into an aperture in the AF. Tubular body 17 may form a
tight seal with the AF. A natural opening in the AF may be enlarged
with a cylindrical shaped trocar before inserting the device.
[0134] FIG. 3F is an axial cross section of the disc and the
embodiment of the invention drawn in FIG. 3E, which illustrates
tubular body (not shown) with porous barrier 22 forming a tight
seal with the surrounding AF of disc 2.
[0135] FIG. 4A is a lateral view of an alternative embodiment of
the invention drawn in FIGS. 2D and 3B. The device has a tubular
body 17 with external threads 25 connected or coupled to mesh patch
10. The device could made of porous mesh, collagen, allograft,
xenograft, autograft, metallic, or polymer materials.
Alternatively, the device may be made of more than one
material.
[0136] FIG. 4B is a posterior view of the embodiment of the
invention drawn in FIG. 4A, showing the face of porous mesh patch
10.
[0137] FIG. 4C is an axial cross section of disc 2 and the
embodiment of the invention drawn in FIG. 4A. Body 17 with threads
25 fits within aperture 4 of disc 2. The inner diameter of body 17
with threads 25 is smaller than the inner diameter of aperture 4.
The configuration permits NP material 6 to spiral around body 17
and threads 25. Mesh patch 10 lies over the outer layer of the AF
of disc 2. Mesh patch 10 of the device prevents NP 6 from extruding
from disc 2. Thus, the device permits NP tissue 6 to pass into
aperture 4 but not through aperture 4 of the intervertebral disc
2.
[0138] FIG. 4D is a posterior view of a sagittal cross section of
the spine and the embodiment of the invention drawn in FIG. 4C.
Mesh patch 10 of the invention has been attached to the AF adjacent
to aperture 4 in disc 2. Sutures or other anchors may be used to
attach the device to the AF, as described in U. S. Patent
Application Nos. 60/808,795, filed May 26, 2006, entitled
"Fastening Assemblies for Disc Herniation Repair and Methods of
Use," 60/748,518, filed Dec. 8, 2005, which was previously
incorporated by reference. For example, flexible T-shaped anchors
with a transverse component placed behind the AF and a longitudinal
component the passes through the AF could be used to fasten the
device to the AF.
[0139] FIG. 4E is a posterior view of a sagittal cross section of
the spine and an alternative embodiment of the invention drawn in
FIG. 4D. The device has been attached to the spine with suture
anchors. Two anchors 103a-b have been inserted into the vertebra
122 cranial (towards the head) to the disc 2 and two anchors 103c-d
have been inserted into the vertebra 124 caudal (towards the feet)
to the disc 2. Anchor 103 has a first portion capable of being
inserted into or otherwise attached to a bone, such as a vertebra.
Anchor 103 also has a second portion capable of being coupled with
suture 101, such as an opening adapted to receive a suture
therethrough. In one embodiment, anchor 103 is a screw having a
hole through the head of screw. Suture 101 is threaded through the
hole. Alternatively, suture 101 may be wrapped around a portion of
anchor 103. Suture 101 is preferably made of polyester or other
weldable material and has a break--strength of greater than about
22 lbs. Screw or anchor 103 is preferably about 3 mm in diameter,
alternatively about 4 mm in diameter, and between about 5 mm and
about 10 mm in length. However, alternative sized sutures or screws
may be used with this invention. Anchors 103 are preferably made of
an MRI compatible and radio-opaque material such as Titanium.
Plastic or bioresorbable anchors may also be used with this
invention. Anchors 103 are preferably self-drilling and
self-tapping. Non-threaded anchors with expandable or deployable
components may also be used with this invention.
[0140] As seen in FIG. 4E, the free ends of the sutures may be
attached, e.g., through welding, to each other to hold the mesh
patch in place. For example, a first end of suture 101b may be
welded or otherwise connected to a first end of suture 101c to form
a connection diagonally across the back of the mesh patch.
Similarly, a first end of suture 101a may be welded or otherwise
connected to a first end of suture 101d to form another connection
diagonally across the back of the mesh patch. A second end of
suture 101b may be connected to a second end of suture 101d to form
a generally vertical connection across the back of the mesh patch.
A second end of suture 101a may be connected to a second end of
suture 101c to form an additional generally vertical connection
across the back of the mesh patch. Alternatively, the free ends of
the sutures could be connected to form generally horizontal
connections across the back of the mesh patch. The sutures may
additionally or optionally be welded directly to the mesh patch.
Alternatively, the free ends of the sutures could be fastened to
the anchors. The anchors may have a clamp-like mechanism that locks
the free ends of the sutures to the anchors. The invention fastens
sutures to each other, to the mesh, or to the anchors without
requiring tying knots in the sutures.
[0141] Mesh patch 10 is smaller than the area between the four
anchors 103a-d. The mesh patch could be smaller than the distance
between the anchors by a ratio of 4:5. For example, if the distance
between the anchors in the same vertebra is about 10 mm and the
distance between anchors in the adjacent vertebra is about 15 mm, a
rectangular mesh patch would preferably be about 8 mm.times.12 mm.
Alternatively, the ratio may be about 4.5:5, alternatively about
3.5:5,alternatively about 3.0:5, alternatively about 2.5:5. The
size of the mesh patch could be determined by the pair of suture
anchors that are closest together in the vertical and the
horizontal directions. Sutures 101a-d can be welded to each other
and/or to mesh patch 10 using an ultrasonic welding instrument,
such as supplied by Axya Medical Beverly, Mass.
[0142] FIG. 5A is a posterior view of a coronal cross section of
the spine and the first component of the preferred embodiment of
the invention. The circles represent cross sections of the pedicles
of vertebrae 1122 and 1124. Disc 1120 is the rectangular structure
between vertebrae 1122 and 1124. Elongated aperture 1123 is drawn
on the posterior aspect of the Anulus Fibrosus (AF) of disc 1120.
Two suture anchors 1400a, b were placed in vertebra 1122 cranial to
the disc and two suture anchors 1400c,d were placed in vertebra
1124 caudal to the disc. A pair of anchors is located medial to the
aperture and a pair of anchors is located lateral to the anchors.
The four anchors can be grouped into a pair (an anchor cranial to
the disc and an anchor caudal to the disc) to the left of the
aperture and a pair to the right of the aperture. The cranial pair
anchors 1400a,b are preferably located at least 2 mm cranial to the
junction of cranial vertebra 1122 and disc 1120. The caudal pair of
anchors 1400c,d are preferably located at least 2 mm caudal to the
junction of caudal vertebra 1124 and disc 1120. Alternatively, the
anchors can be placed about 1 to about 15 mm cranial and about 1 to
about 15 mm caudal to the junctions of the disc and the vertebrae.
The anchors are also placed at least 2 mm medial and 2 mm lateral
to aperture 1123 in the anulus fibrosus. Alternatively, the anchors
may be placed about 1 to about 15 mm medial and lateral to aperture
1123. Sutures 401a-d are marked to identify the medial 1402a-d and
the lateral 1403a-d halves of the sutures 1401a-d. For example, the
medial ends 1402a-d of the sutures could be a first color and the
lateral ends 1403a-d of the sutures could be a second color.
Alternatively, the first ends of the sutures could have spots,
stripes, bands, or other markings to differentiate the first ends
from the second ends of the sutures. Multifilament sutures could
incorporate colored fibers to help differentiate the medial and the
lateral ends of the sutures. The suture anchors 1103a-d are
preferably about 3 mm in diameter and about 7 mm in length.
Alternatively, suture anchors 1103a-d may be about 2 to about 7 mm
in diameter and about 4 to about 15 mm in length.
[0143] Suture anchor 1400 comprises suture 1401 and screw (or
anchor) 1103. Anchor 1103 has a first portion capable of being
inserted into or otherwise attached to a bone, such as a vertebra.
Anchor 1103 also has a second portion with an opening 1104 adapted
to receive a suture therethrough. In one embodiment, anchor 1103 is
a screw having a hole through the head of screw. Suture 1401 is
threaded through hole 1104. Anchors 1103a-d are preferably made of
titanium, plastic, or other MRI compatible material. The anchors
may be absorbable. The holes for anchors 1103a-d are preferably
created with a 1.5 mm diameter drill bit and a drill guide.
Alternatively, the anchors could be self-drilling and self-tapping.
The handle of the instrument used to insert the anchors could have
markings to identify the two ends of the fixation suture. For
example, one half of a white fixation suture could be dipped in
blue dye. A blue circle could be placed on the handle of the
instrument used to insert the anchors. The anchors could be placed
into the insertion tool with the blue end of the suture passing
from the side of the instrument with the blue circle.
[0144] FIG. 5B is an exploded lateral view of sutures 1401 and
anchors 1103 drawn in FIG. 5A. As explained previously, suture 1401
is marked to identify the medial 1402 and the lateral 1403 halves
of the suture 1401. The sutures are preferably #2 nylon or
polyester sutures. Alternatively, the sutures may be made of other
material. The sutures are preferably about 0.5 mm in diameter and
about 90 cm in length. Alternatively the sutures are about 0.2 to
about 1.0 mm in diameter and about 20 to about 110 cm or more in
length. Monofilament or multifilament sutures may be used. The
sutures may be made of elastic or inelastic materials. For example,
the sutures may reversibly lengthen about 0.1 to about 10 mm.
Alternatively, elastic sutures may reversibly lengthen about 1 to
about 4 mm. Elastic sutures that are attached to anchors within the
vertebrae can lengthen as the spine is moved from a neutral or and
extended position to a flexed position. Elastic sutures would
decrease the force on the anchors with spinal flexion. Elastic
sutures would be less likely to break with repetitive spinal
movement or large ranges of spinal movement. Relatively inelastic
sutures may be preferred in embodiments of the invention that are
used for spinal fusion.
[0145] The sutures or the welds are preferably designed to break at
a lower force than is required to pull the anchors out of the
vertebrae. The sutures or welds could be designed to break at a 30
lb force less than is required to pull the anchors out of the
vertebrae. For example, AxyaLoop Ti 3.0 (Axya Medical, Beverly
Mass.) suture anchors have a mean pullout force of about 77.9
pounds in cancellous bone. Such anchors could be used with # 2
Fiberwire suture (Arthrex, Naples Fla.), which has a breakage
strength of 44 lbs. Alternatively, the suture or suture fastening
method, such as welding or clamps within the anchors, could break
or release at a force approximately 70 lbs below the force required
to pull the anchors out of vertebrae. For example, #5 Fiberwire
suture, which has a breakage strength of about 112 lbs, could be
used with Herculon suture anchors, which have a mean pullout force
of 190 lbs. Alternatively, the sutures or suture fixation/fastening
mechanism could be designed to break at a force less than about 10,
about 20, about 30, about 40, about 50, about 60, or about 80, or
between about 10 and 100 pounds or less than the force required to
pull the anchors out of vertebrae. Sutures made of resorbable
material, such as Vicryl, Vicryl Plus, Monocryl, or PDS II
(Ethicon, Piscataway N.J.) could be used to reduce force on the
anchors as the sutures resorb. The invention prevents the anchors
from pulling out of the vertebrae. Extruded anchors could damage
structures, such as the esophagus, that lie over the vertebrae
[0146] FIG. 5C is a posterior view of patch components of the
invention drawn in FIG. 5A. A mesh in-growth component 1110 is
connected to an anti-adhesion component 1115 by a connecting suture
1117. Mesh component 1110 is preferably made of polyester. Mesh
component 1110 is preferably about 0.25 mm thick. Alternatively,
mesh component 1110 may be about 0.1 to about 2.0 mm thick. The
mesh preferably has 1 by 1 mm pores. Alternatively, the mesh may
have pores about 0.001 by about 0.005 mm in size to about 1 by
about 3 mm in size. The holes in the mesh may be circular or
elongate in shape. The mesh preferably has a burst--strength of 50
to 100 PSI. Alternatively, the mesh may have a burst--strength of
25 to 175 PSI. The mesh may be made of other synthetic materials
such as polypropylene. Alternatively, the mesh may be made of
processed allograft or xenograft tissue. The mesh component is
preferably supplied in various sizes. For example, the mesh may be
supplied in 10 by 10 mm, 12 by 14 mm, 13 by 20 mm, 14 by 18 mm, and
16 by 50 mm sizes. Alternative sizes of mesh may be supplied. The
mesh may be cut by surgeons to properly fit patient's anatomy.
Anti-adhesion cover 115 is preferably made of ePTFE. Alternatively,
the cover may be made of other anti-adhesion materials, including
absorbable materials such as, Seprafilm (Genzyme Corporation,
Cambridge, Mass.), and mixtures of oxidized atelocollagen type I,
polyethylene glycol, and glycerol. The anti-adhesion cover is
preferably 2 mm wider and 2 mm taller than the mesh component.
Alternatively, anti-adhesion cover 1115 may be the same size as the
mesh patch or 3 to 15 mm wider and/or taller than the mesh patch.
The cover is preferably the same shape as mesh patch 1110.
Alternatively, cover 1115 may be a different shape than mesh patch
1110. For example, cover 1115 could include arms that extend from
one or more sides of the cover. Cover 1115 is applied to the
posterior surface of mesh component 1110. Cover 1115 is preferably
connected to the patch by connecting suture 1117, e.g., a 2-0
suture. Alternatively, connecting suture 1117 may be a 4-0 to #3
suture. Connecting suture 1117 is preferably made of monofilament
nylon. Alternatively, multifilament sutures made of polyester or
other material, including resorbable materials may be used in other
embodiments of the invention. The sutures preferably have at least
a 22 lb. break-strength. Alternatively, the sutures may have a
break-strength of 10 to 140 lbs. The sutures may also be metal
cables with a break strength of more than 100 lbs. For example,
braided cables could be connected by crimping the ends of the
cables together by a separate component, rather than by welding.
Alternative fastening methods or devices may be used to connect the
components. For example, adhesives could be used to connect a
portion of the components together. The mesh and cover components
may be made of elastic or inelastic materials. Elastic material
mesh and/or cover components may reversibly lengthen about 0.1 to
about 10 mm in any all directions. Alternatively the components may
lengthen by about 1 to about 5 mm. The components could be more
elastic in one direction than in another direction. For example,
the materials could reversibly lengthen in a cranial to caudal
direction more than they lengthen in a left to right direction.
[0147] FIG. 5D is a lateral view of suture managing tool component
1410 of the invention. Slots 1415 on the posterior aspect 1414 of
the tool are sized to enable the fixation sutures 1401 from the
anchors and the connecting sutures 1117 to be press-fit into slots
1415. The edges of the slots are rounded to avoid injuring the
sutures are the sutures are repeated pressed into and pulled out of
the slots. An adhesive is preferably applied to base 1412 of the
tool. The tool is preferably about 2 to about 10 cm wide, about 1
to about 4 cm tall, and about 4 to about 20 cm long.
[0148] FIG. 5E is a view of the end of the embodiment of the
invention drawn in FIG. 5D, which illustrates base 1412 and
posterior aspect 1414 attached generally perpendicularly to base
1412.
[0149] FIG. 5F is a posterior view of a portion of a patient's
back, a surgical wound and the embodiments of the invention drawn
in FIGS. 5A to 5E. Suture management tools 1410 were placed onto
the patient's back cranial and caudal to the surgical wound. The
adhesive on base 1412 may be used to bond the tools to the
patient's skin or plastic cover 1417 over the patient's skin. The
ends of the fixation sutures 14401a-d and the connecting sutures
1117 were press fit into slots 1415 of suture management tools
1410. The markings on the fixation sutures and the position of the
sutures in the suture management tools help the surgeon identify
the origin of the sutures. Anchors 1103a-d were preferably recessed
1 mm into the vertebrae 1122, 1124. Alternatively, the anchors may
project 2 mm from the vertebrae 1122, 1124 or be recessed 2 to 10
mm into the vertebrae. Bone could grow into the holes through which
the anchors were inserted (proximal to the anchors). The new bone
could prevent extrusion of recessed anchors. Alternatively, as
noted in U.S. application Ser. No. 11/635,829 entitled "Sutures for
use in the Repair of Defects in the Anulus Fibrosus," which is
hereby expressly incorporated by reference in its entirety, an
in-situ curing material, such as a bioactive cement, may be
injected into the bone proximal to the anchor to increase the force
required to pull the anchor out of the bone. Anchors 1103 were
rotated to orient the eyelet 1104 of the anchors generally parallel
to disc 1120. The configuration provides a medial and a lateral end
of each fixation suture. For example, as illustrated, the medial
ends 1402a-d of the fixation sutures have small horizontal lines to
differentiate the medial ends from the lateral ends 1403a-d of the
sutures 1401a-d. Mesh patch 1110 is preferably 4 mm wider than the
space between the medial and the lateral pairs of anchors (each
pair has an anchor cranial to the disc and an anchor caudal to the
disc). Alternatively mesh patch 1110 could be 1 to 10 mm wider than
the space between the medial and the lateral pairs of anchors. The
mesh patch is preferably as tall as the shortest distance between
the pair of medial and the pair of lateral anchors. The
configuration allows the mesh patch to lie against disc 120 without
wrinkles in the mesh. Alternatively, the mesh patch could be wider
than the distance between the medial or the lateral, or both, pairs
of anchors. Alternatively, the mesh patch could be 1 to 6 mm
shorter than the distance between the medial or the lateral pairs
of anchors. The mesh preferably extends over the vertebrae cranial
and caudal to the disc by at least 2 mm. Alternatively, the mesh
could extend over the vertebrae by 1 to 10 mm. Alternatively, the
mesh may extend over the disc but not the vertebrae. The cover
component (not shown) is preferably added to the device at the end
of the procedure.
[0150] FIG. 5G is a posterior view of the embodiment of the
invention drawn in FIG. 5F. The medial end of the fixation suture
from the "10 o'clock" anchor 1402b was welded or otherwise fastened
to the medial end of the suture from the "4 o'clock" anchor 1402d.
The welded sutures were placed between the cranial and the caudal
ends of the connecting suture 1117. Tension was applied to the free
ends of the welded sutures 1401b, d to position the welded area of
the sutures over the center of the mesh. The welded sutures hold
the mesh in position over the aperture in the disc. The welding
system supplied by Axya Medical (Beverly, Mass.) could be used to
weld the sutures.
[0151] FIG. 5H is a posterior view of the embodiment of the
invention drawn in FIG. 5G. The medial ends of the "2 o'clock"
1402a and the "8 o'clock" 1402c fixation sutures were welded in the
manner described in the text of FIG. 5G.
[0152] FIG. 51 is a posterior view of the embodiment of the
invention drawn in FIG. 5H. The lateral end of the "2 o'clock"
suture 1403a was attached to the lateral end of the "4 o'clock"
suture 1403d. The lateral end of the "8 o'clock" suture 1403c was
attached to the lateral end of the "10 o'clock" suture 1403b.
Tension was applied to the ends of the sutures before attaching the
sutures. Tension on the final two pair of attached sutures, before
attaching the sutures, tightens all the attached fixation sutures.
The sutures may be attached by welding, crimping, or other means.
By applying tension to the lateral fixation sutures before welding
or otherwise attaching them, the surgeon is able to apply
compression to materials, such as bone graft devices, that are
placed in the intradiscal space. For example, if a piece of bone
graft was placed into the intradiscal space between the vertebrae,
and the surgeon compressed down on the lateral fixation sutures,
the compression of the vertebrae on the bone graft could facilitate
fusion. Alternatively, the sutures could be fixed to the anchors.
Such configuration enables application of tension to each pair of
welded sutures. For example, twenty (20) pounds of tension could be
applied to the vertical pairs of sutures and eight (8) pounds of
tension could be applied to the diagonal pairs of sutures. In
general about 4 to about 80 pounds of tension are applied to the
sutures. Smaller amounts of tension are applied to the sutures in
embodiments of the invention that do not restrict spinal motion and
larger amounts of tension are applied to the sutures in embodiments
of the invention that are designed to restrict or eliminate
movement between the vertebrae. The invention also prevents loosing
of all welded sutures if a single suture breaks or a single weld
fails. Mesh patch 110 should extend lateral to both pairs of
attached vertical sutures. The ends of the sutures are preferably
cut with guillotine-like arthroscopic suture cutter. Such cutters
are the safest way to cut sutures in the spinal canal.
[0153] A device that applies compression may be used to pull the
vertebrae together before the sutures are connected to one another,
for example, by welding the ends of the sutures or by fastening the
sutures to the anchors. For example, a distraction device, such as
a Caspar distractor, could be used to force the vertebrae together
before fastening the sutures. The invention helps compress
intradiscal material, such as a bone graft. Such compression
facilitates spinal fusion. The natural elasticity of the spinal
tissues apply tension on the sutures when the external compression
or "preload" is released, thus stiffening the spine. Additional
tension may be applied to the sutures before welding or fastening
the sutures. The compression device preferably applies at least 20
N of compression to cervical vertebrae and 400 N to lumbar
vertebrae before the sutures are fastened or welded together.
Alternatively, about 10, about 30, about 40, about 50 or more
Newton forces (or forces between 10-70 N) could be used to compress
cervical vertebrae and about 100, about 200, about 300, about 350,
about 450 or more Newton forces (or forces between 100 and 600 N)
could be used to compress lumbar vertebrae together. Preoperative
bone densities could be used to help select the "preload" force to
apply to the vertebrae.
[0154] FIG. 5J is a posterior view a coronal cross section of the
spine and the embodiment of the invention drawn in FIG. 5I. The
suture management tools were removed. The cover component 1115 was
threaded over the ends of connecting suture 1117. Connecting suture
1117 holds mesh patch 1110 to the fixation sutures 1401a-d and
cover component 1115 to mesh component 1110.
[0155] FIG. 5K is a posterior view of a coronal cross section of
the spine and the embodiment of the invention drawn in FIG. 5J. The
ends of the connecting sutures 1117 were welded together. Tension
was applied to the ends of the sutures 1117 before welding the
sutures together. The ends of the sutures 1117 were trimmed.
[0156] FIG. 5L is a posterior view of an alternative embodiment of
the suture holding tool drawn in FIG. 5D. The length and width of
the tool may be adjusted by components that telescope within each
other. Screws 1422a, b may be tightened to maintain the size of
tool 1420. Slots for sutures are located in the top and bottom of
the tool. The corners of the tool have numbers to help identify the
sutures within the slots and the origin of the sutures. The tool is
preferably between 8 and 20 cm in length and between 8 and 20 cm in
width.
[0157] FIG. 6A is an alternative embodiment of the invention drawn
in FIG. 5C. Mesh component 1450 has a tube shape. Alternatively,
the mesh component may have two or more layers fastened together.
The layers of mesh could be oriented perpendicular to one another
in a bias-ply type of arrangement. The device also includes
connecting suture 1117 and cover component 1115.
[0158] FIG. 6B is a posterior view of the embodiment of the
invention drawn in FIG. 6A. The lateral ends of the sutures 1403a,
b from the cranial pair of anchors were passed between the layers
of mesh 1450.
[0159] FIG. 6C is a lateral, view of the embodiment of the
invention drawn in FIG. 6B, which depicts lateral ends 1403a, b of
sutures sandwiched between the layers of mesh of device 1450.
Connecting suture 1117 is stitched through both layers of mesh
device 1450. Connecting suture 1117 is also threaded through
anti-adhesion cover 1115.
[0160] FIG. 6D is a posterior view of the embodiment of the
invention drawn in FIG. 6B. The lateral ends of the sutures 1403c,
d from the caudal pair of anchors were welded to the lateral ends
of the sutures from the cranial pair of anchors 1403a, b. The weld
can be performed outside the surgical wound.
[0161] FIG. 6E is a lateral view of the embodiment of the invention
drawn in FIG. 6D, which depicts lateral ends 1403a-d of sutures
sandwiched between the layers of mesh of device 1450. Connecting
suture 1117 is stitched through both layers of mesh device 1450.
Connecting suture 1117 is also threaded through anti-adhesion cover
1115.
[0162] FIG. 6F is a posterior view of the embodiment of the
invention drawn in FIG. 6D. The mesh layers were "spot welded" 1452
just medial to the vertical arms of the fixation suture (4
rectangular spotted areas). Welding the layers of mesh traps the
vertical arms of the fixation suture within the mesh component. The
"spot welds" 1452 can be performed outside the surgical wound.
Tension was applied to the free ends of the vertical fixation
sutures. Tension pulls the mesh patch into the wound and places the
device over the disc.
[0163] FIG. 6G is a lateral view of the embodiment of the invention
drawn in FIG. 6F, which depicts lateral ends 1403a-d of sutures
sandwiched between the layers of mesh of device 1450. The "spot
welds" 1452 are located just medial to the vertical arms of the
fixation suture 1403. Connecting suture 1117 is stitched through
both layers of mesh device 1450. Connecting suture 1117 is also
threaded through anti-adhesion cover 1115.
[0164] FIG. 6H is a posterior view of the embodiment of the
invention drawn in FIG. 6G. The medial ends of the fixation sutures
were welded together in the manner described in the text of FIGS.
5G and 5H. The medial end of the fixation suture from the "10
o'clock" anchor 1402b was welded or otherwise fastened to the
medial end of the suture from the "4 o'clock" anchor 1402d.
Similarly, the medial ends of the "2 o'clock" 402a and the "8
o'clock" 402c fixation sutures were welded in the manner described
in the text of FIG. 5G. Connecting suture 1117 does not surround
the diagonal fixation sutures. This configuration reduces the
profile of the assembled device.
[0165] FIG. 6I is a lateral view of the embodiment of the invention
drawn in FIG. 6H, which depicts lateral ends 1403a-d of sutures
sandwiched between the layers of mesh of device 1450. The "spot
welds" 1452 are located just medial to the vertical arms of the
fixation suture 1403. The cross-section of the medial ends of
fixation sutures 1402a-d is shown on top of mesh device 1450.
Connecting suture 1117 is stitched through both layers of mesh
device 1450 and does not surround the diagonal fixation sutures.
Connecting suture 1117 is also threaded through anti-adhesion cover
1115.
[0166] FIG. 6J is a posterior view of an alternative embodiment of
the invention drawn in FIG. 6H. The mesh component is narrower than
the distance between the cranial and/or caudal pair of anchors
1103. Tension on the fixation sutures applies tension to the mesh
component 1450. Tension on the mesh component 1450 increases the
stiffness of the component.
[0167] FIG. 7A is a posterior view of the embodiment of the
invention drawn in FIG. 5C. The ends 1454 of the mesh component
1110 are enlarged.
[0168] FIG. 7B is a posterior view of the embodiments of the
invention drawn in FIGS. 5J and 5A. The ends 1450 of the mesh 1110
extend beyond the cranial and the caudal pair of anchors 1103a-d.
The configuration helps prevent the lateral edges of the mesh from
migrating from under the vertical arms 1403a-d of the fixation
sutures. The lateral edges of the mesh could contain a stiffening
component to further reduce the risk of the edges migrating from
under the vertical arms 1403a-d of the fixation sutures.
[0169] FIG. 8A is posterior view of an alternative embodiment of
the invention drawn in FIG. 5C. A weldable fixation component (star
shaped) 1460 has been fastened to the mesh component 1110. The
weldable fixation component 1460 may have a plurality of extensions
1462 that substantially extend to the edges of mesh component 1110.
The extensions may include two horizontal arms 1462h, two vertical
arms 1462v, and four diagonal arms 1462. The weldable fixation
component 1460 is preferably stiffer than the mesh component 1110.
The weldable fixation component 1460 is preferably made of nylon or
polyester and can be about 0.5 mm thick. Alternatively, the
weldable fixation component 1460 can be made of materials other
than nylon or polyester and may be between 0.1 and 3.0 mm thick.
The weldable fixation component 1460 may have features that enable
attachment of the cover component. For example, the weldable
fixation component 1460 may have a hole 1464 that receives a
projection from the cover component. The fixation component 1460 is
preferably stiffer than the mesh.
[0170] FIG. 8B is a posterior view of the embodiment of the
invention drawn in FIG. 8A. The mesh 1110 is preferably fastened to
only a portion of the fixation component 1460. For example, the
mesh 1110 may be fastened to the horizontal arms 462h of the
fixation component.
[0171] FIG. 8C is a lateral view of the embodiment of the invention
drawn in FIG. 8B. This illustrates that the mesh component 1110 is
attached to the horizontal extensions 1462h.
[0172] FIG. 8D is an end view of the embodiment of the invention
drawn in FIG. 8C, which also illustrates that the mesh component
1110 is attached to the horizontal extensions 1462h.
[0173] FIG. 8E is a posterior view of the embodiments of the
invention drawn in FIGS. 5A and 8A. The medial ends of the fixation
sutures 1402a-d were welded to the diagonal arms 1462 of the
fixation component 1460. The welds are preferably performed outside
the surgical wound.
[0174] FIG. 8F is a posterior view of the embodiment of the
invention drawn in FIG. 8E. Tension was applied to the free ends of
the fixation suture 1403a-d to pull the mesh component 1110 into
the wound and place the mesh component 1110 over the disc (not
shown).
[0175] FIG. 8G is a posterior view of the embodiment of the
invention drawn in FIG. 8F. The lateral ends 1403a-d of the
fixation sutures were welded together in the manner described in
the text of FIG. 51. The lateral end of the "2 o'clock" suture
4103a was welded to the lateral end of the "4 o'clock" suture
1403d. The lateral end of the "8 o'clock" suture 1403c was welded
to the lateral end of the "10 o'clock" suture 1403b. Tension was
applied to the ends of the sutures before welding the sutures.
Tension on the final two pair of welded sutures, before welding the
sutures, tightens all the welded fixation sutures. The ends of the
sutures are preferably cut with guillotine-like arthroscopic suture
cutter. The vertical fixation arms 1403a-d preferably lie over the
horizontal arms 1462h of the fixation device.
[0176] FIG. 8H is a lateral view of an alternative embodiment of
cover component 1115. The distal portion of the cover 1115 has a
projection 1116. The projection 1116 from the cover 1115 can be
snapped into the hole 1464 of the fixation component 1460.
Alternative methods may be used to connect the two components.
[0177] FIG. 8I is a posterior view of the embodiments of the
invention drawn in FIGS. 8G and 8H. The cover component 1115 has
been fastened to the mesh or fixation components (not shown).
[0178] FIG. 9A is a posterior view of an alternative embodiment of
the invention drawn in FIG. 8A. The fixation component has long
diagonal arms 1462. The ends of the horizontal arms 1462h of the
fixation component have recessed regions (small vertical
rectangles) 1465. The long arms 1462 facilitate use of the welding
tool. The excess suture is cut after welding the sutures together.
The excess suture was removed in FIGS. 9B-9D.
[0179] FIG. 9B is a posterior view of the embodiments of the
invention drawn in FIGS. 5A and 9A. The medial ends 1402a-d of the
fixation sutures were welded, or otherwise connected, to the
diagonal arms 1462 of the fixation component 1460. The ends of the
welded sutures were cut and removed.
[0180] FIG. 9C is a posterior view of the embodiment of the
invention drawn in FIG. 9B. The fixation component 1460 with the
welded fixation sutures 1401a-d was fastened to a mesh component
1110. The components can be welded together. Other fastening
methods or devices may be used to connect the two components. The
two components are preferably fastened together outside the wound.
Tension is applied to the free ends of the fixation sutures 1401
a-d to pull the assembled device into the wound and place the
device over the disc.
[0181] FIG. 9D is a posterior view of the embodiment of the
invention drawn in FIG. 9C. The vertical arms of the fixation
sutures 1403a-d were welded together in the manner described in the
text of FIG. 5I. The welded vertical fixation sutures preferably
sit within the recessed portions 1465 of the horizontal arms 1462h
of the fixation component 460.
[0182] FIG. 9E is a lateral view of the embodiment of the invention
drawn in FIG. 9D, which illustrates the vertical arms (or lateral
sutures) 1403a-d sitting within recessed regions 1465 of the
horizontal arms 1462h.
[0183] FIG. 10A is a posterior view of an alternative embodiment of
the invention drawn. A weldable suture 1470 was threaded through
the mesh component 1110 such that exposed stitches 1472 are visible
on the top side of the mesh component 1110.
[0184] FIG. 10B is a posterior view of the embodiments of the
invention drawn in FIG. 10A. The medial end 1402b of the "10
o'clock" suture was passed under the "purse string" suture or
exposed stitch 1472 and welded to the medial end of the "4 o'clock"
suture 1402d after passing that end under a second portion of the
"purse string" or exposed stitch 1472.
[0185] FIG. 10C is a posterior view of the embodiment of the
invention drawn in FIG. 10B. The medial ends of the "2 o'clock"
1402a and "8 o'clock" 1402c sutures were passed under the "purse
string" 1472 and welded together.
[0186] FIG. 10D is a posterior view of the embodiment of the
invention drawn in FIG. 10C. The ends of the "purse string" 1470
were welded together after applying tension to the ends of the
suture. The ends of the "purse string" are preferably welded
together outside the wound. Tension is applied to the free ends of
the fixation sutures 1403a-d to pull the assembled device into the
wound and place the device over the disc (not shown).
[0187] FIG. 10E is a posterior view of the embodiment of the
invention drawn in FIG. 10D. The lateral ends of the fixation
sutures 1403a-d were welded together in the manner described in the
text of FIG. 5I. The lateral end of the "2 o'clock" suture 1403a
was welded to the lateral end of the "4 o'clock" suture 1403d. The
lateral end of the "8 o'clock" suture 1403c was welded to the
lateral end of the "10 o'clock" suture 1403b. Tension was applied
to the ends of the sutures before welding the sutures. Tension on
the final two pair of welded sutures, before welding the sutures,
tightens all the welded fixation sutures. The ends of the sutures
are preferably cut with guillotine-like arthroscopic suture cutter.
A cover component may be attached to the fixation sutures or the
mesh component.
[0188] FIG. 11 is a posterior view of an alternative embodiment of
the invention drawn in FIG. 10E. The "purse string" or suture 1470
is placed such that exposed stitches 1472 are positioned closer to
the center of the mesh. This configuration enables the fixation
sutures 1401a-d to apply tension to the mesh 1110. The fixation
sutures apply tension in at least the cranial to caudal direction
and the left to right direction.
[0189] FIG. 12A is a posterior view of an alternative embodiment of
the invention drawn in FIG. 10A. Two loops 1475 were passed under,
the "purse string" or exposed stitches 1472. The loops 1475 are
preferably made of nylon or other somewhat stiff material.
[0190] FIG. 12B is a posterior view of the embodiment's invention
drawn in FIGS. 5A and 12A. The ends of the fixation sutures 1401a-d
were passed through the openings in the loops 1475.
[0191] FIG. 12C is an exploded posterior view of the embodiment of
the invention drawn in FIG. 12B. The loops 1475 were removed from
the mesh 1110. The loops were removed by pulling on the central
portion of the loops. The ends of the fixation sutures 1401a-d were
pulled under the purse string 1472 as the loops 1475 were removed
from the mesh 1110. The purse string 1470 is tightened and welded
in the manner taught in FIG. 10C. The fixation sutures 1401a-d may
be welded in the manner described in the text of FIGS. 5G through
5I.
[0192] FIG. 12D is a posterior view of an alternative embodiment of
the invention drawn in FIG. 12A. Loops 1475 of FIG. 12A were
replaced by devices with slit-like ends. The ends of the fixation
sutures 1401a-d are press fit into the slots/slits at the ends of
the components that were placed under the "purse string" 1470. The
purse string 1470 is tightened and welded in the manner taught in
FIG. 10C. The fixation sutures 1401a-d are welded together in the
manner taught in FIGS. 5G to 5I.
[0193] FIG. 13 is an axial cross section of a disc 1120, the thecal
sac 1121, nerves 1125, and the embodiment of the invention drawn in
FIG. 5K. The device comprising a mesh component 1110, fixation and
connecting sutures, and anti-adhesion cover 1115 was placed on the
left side of the posterior aspect of the disc 1120. Eccentrically
placed devices are used to treat defects of the disc that are
limited to one side of the disc.
[0194] FIG. 14 is an axial cross section of a disc 1120, the thecal
sac 1121, nerves 1125, and the embodiment of the invention drawn in
FIG. 5K. The device comprising a mesh component 1110, fixation and
connecting sutures, and anti-adhesion cover 1115 extends across
most of the posterior aspect of the disc 1120. Such placed devices
are used to treat defects 1123 across central portion of the
posterior aspect of the disc 1120.
[0195] FIG. 15A is a posterior view of a portion of the spine and
the embodiment of the invention drawn in FIG. 5A. Fixation sutures
1401a-d are seen exiting the spinal canal lateral to the thecal sac
1121. Anchors were placed in the left and the right sides of the
posterior aspects of the vertebrae 1122, 1124.
[0196] FIG. 15B is a posterior view of a coronal cross section of
the spine and the embodiment of the invention drawn in FIG. 15A.
The anchors 1103a-d and sutures 1401a-d are seen on the left and
the right sides of the thecal sac 1121.
[0197] FIG. 15C is a lateral view of a suture passing tool 1480.
Suture passing tool 1480 has a handle 1482, flexible, curved distal
portion 1484 with a loop 1486 passing through a lumen of the curved
distal portion 1484.
[0198] FIG. 15D is a lateral view of the suture tool drawn 1480 in
FIG. 15C. The loop 1486 that passes through the tool has been
advanced further out the distal end of the tool 1480 than the loop
drawn in FIG. 15C.
[0199] FIG. 15E is a posterior view of a coronal cross section of
the spine, the embodiment of the invention drawn in FIG. 15B and
the suture passing tool 1480. The distal loop 1486 of the suture
passing tool 1480 was passed between the disc 1120 and the thecal
sac 1121.
[0200] FIG. 15F is an axial cross section of the disc, the
embodiment of the invention drawn in FIG. 15E and the suture
passing tool 1480. The distal loop 1486 of the suture passing tool
1480 was passed between the disc 1120 and the thecal sac 1121.
Fixation sutures 1401c,d have already been anchored into the
vertebra caudal to the disc 1120.
[0201] FIG. 15G is a posterior view of a coronal cross section of
the spine, the embodiment of the invention drawn in FIGS. 5A and
5C, and the suture passing tool 1480. The medial ends of the
fixation sutures 1402b,c from the left side of the vertebrae were
passed through the distal loop 1486 of the suture passer 1480.
Sutures from the right side of the mesh were also passed through
the distal loop of the suture passer. A positioning suture 1490 was
also passed through the loop 1486 before both ends were threaded
into the mesh patch 1110 so that the suture passing tool 1480 can
be used to position the mesh patch 1110. The positioning suture
1490 is used to pull the mesh under the thecal sac. The positioning
suture 1490 is removed after passing the mesh under the thecal
sac.
[0202] FIG. 15H is an axial cross section of a disc and the
embodiment of the invention drawn in FIG. 15G.
[0203] FIG. 15I is a posterior view of a coronal cross section of
the spine and the embodiment of the invention drawn in FIG. 15G.
The suture passing tool (not shown) was used to pull the medial
ends 1402b,c of the fixation sutures from the left side of the
vertebrae, under the thecal sac 1121 and out the right side of the
spinal canal. The tool was also used to pull the mesh patch 1110
under the thecal sac 1121 and across the posterior aspect of the
disc 1120. The cover component 1115 can be seen on the left side of
the picture. The fixation sutures on the right side of the spinal
canal were not drawn. The suture passing tool and the positioning
sutures from the mesh patch were removed after passing the patch
and the fixation sutures.
[0204] FIG. 15J is an axial cross section of a disc and the
embodiment of the invention drawn in FIG. 15I. The connecting
suture 1117 passes through the left sides of the mesh patch 1110
and cover component 1115.
[0205] FIG. 15K is a posterior view of a coronal cross section of
the spine and the embodiment of the invention drawn in FIG. 15I.
The diagonal arms of the fixation sutures 1402a-d were welded
together from the right side of the spinal canal. Tension was
applied to the free ends of the welded fixation sutures to position
the welded areas of the sutures over the central portion of the
mesh patch 1110. The lateral arms of the left fixation sutures
1403b,c were welded from the left side of the spinal canal. The
lateral arms of the right fixation sutures 1403a,d were welded from
the right side of the spinal canal.
[0206] FIG. 15L is a posterior view of a coronal cross section of
the spine and the embodiment of the invention drawn in FIG. 15K.
The anti-adhesion cover 1115 was passed between the thecal sac 1121
and the mesh patch 1110. The cover 1115 could be passed with the
suture passing tool. The connecting suture 1117 was welded from the
left side of the spinal canal.
[0207] FIG. 16A is a posterior view of an alternative embodiment of
the invention drawn in FIG. 5C. A reinforcement band 1492 courses
through or over the mesh patch 1110. The reinforcement band 1492 is
preferably made of polyester or polypropylene. Alternatively, the
band 1492 may be made of nylon, titanium, or other synthetic or
natural material. The band 1492 has a higher tensile strength than
the mesh. The band 1492 is preferably a closed loop. The loop can
be square, circular or other shape. In one embodiment, the
reinforcement band 1492 could be welded to the mesh component 1110.
Alternative methods or devices may be used to fasten the devices
such as adhesives, sutures, or staples. Applying the reinforcement
member 1492 to the posterior surface of the mesh 1110 maximizes the
area of the mesh that is available for connective tissue in-growth
from the spinal tissues anterior to the mesh.
[0208] FIG. 16B is a posterior view of the embodiments of the
invention drawn in FIG. 5J and 16A. The fixation sutures 1401a-d
pass through the mesh 1110 and through the central portion of the
high tensile strength loop 1492. Alternative fixation members may
be fastened to the mesh central to the loop. The fixation members
1401a-d may pull on the reinforcement member 1492. The
configuration permits the fixation members 401a-d to apply tension
to the mesh without pulling through the mesh.
[0209] FIG. 17A is a posterior view of an alternative embodiment of
the invention drawn in FIG. 16A. Reinforcing members or bands 1494
course through the mesh. The ends of the reinforcing bands 1494
have features that facilitate fastening of fixation members. For
example, the ends of the bands may have reinforced circular
openings 1495.
[0210] FIG. 17B is a posterior view of the embodiment of the
invention drawn in FIG. 17A and FIG. 17 of provisional application
entitled "Fastening Assemblies for disc Herniation repair and
Methods of Use" (U.S. Application Ser. No. 60/808,795), which is
hereby expressly incorporated by reference in its entirety. Sutures
1497 with enlarged ends 1498 of the fixation members were placed
through the openings 1495 in the reinforced regions of the mesh
1110.
[0211] FIG. 18A is a posterior view of an alternative embodiment of
the invention. The reinforcement component is a closed loop. The
reinforcement component also has vertical 1496v, horizontal 1496h,
and diagonal 1496d members. Portions of the reinforcement members
are posterior to the mesh. For example, strands of reinforcement
material may extend from the corners of the reinforcement
square.
[0212] FIG. 18B is a posterior view of the embodiment of the
invention drawn in FIG. 18A wherein fixation members 1402a-d have
been welded or otherwise attached to the strands 1496 of the
reinforcement component.
[0213] FIG. 19 is a posterior view of an alternative embodiment of
the invention. The periphery of the mesh 1110 is reinforced with
reinforcement members 1502. Diagonal reinforcement members 1504
also course across the mesh 1110.
[0214] FIG. 20 is a posterior view of an alternative embodiment of
the invention drawn in FIG. 17A. The reinforcement members have
openings 1495, vertical 1499v, horizontal 1499h, and diagonal
components 1494.
[0215] FIG. 21A is a lateral view of an alternative embodiment of
the invention drawn in FIG. 5D. The device 1510 is smaller than the
device 1410 drawn in FIG. 5D. The device 1510 has two slots 1515 to
receive sutures. Alternatively, the device 1510 could have one to
three or more slots 1515.
[0216] FIG. 21B is a view of the top of the embodiment of the
invention drawn in FIG. 21A, which illustrates base 1512 and
posterior aspect 1514 attached generally perpendicularly to base
1512.
[0217] FIG. 22A is a posterior view of an alternative embodiment of
the invention drawn in FIG. 9A. The device 1460 has features, such
as slots 1462 that make the device more flexible in one direction
(four small rectangles near the center of the device). The features
help prevent the component compressing nerves should the component
become separated from one or more fixation suture.
[0218] FIG. 22B is a lateral view of a portion of the embodiment of
the invention drawn in FIG. 22A. The extension 1462 includes a slot
feature 1463.
[0219] FIG. 22C is a lateral view of the embodiment of the
invention drawn in FIG. 22B. The drawing illustrates how the
extension 1462 bends easily in the direction opposite of the
slot-like feature 1463.
[0220] FIG. 22D is a lateral view of the embodiment of the
invention drawn in FIG. 22C. The drawing illustrates how the
extension 1462 resists bending in the direction of the slot-like
feature 1463.
[0221] FIG. 22E is posterior view of the embodiment of the
invention drawn in FIG. 22A and a mesh component 1110. The
selectively flexible component 1460 is attached to the mesh
component 1110. The components are preferably attached along the
vertical 1462v and horizontal 1462h members of the selectively
flexible component 1460. The diagonal members 1462 are not attached
to the mesh component 1110. The configuration enables fixation
sutures to be welded to the device. The components can be attached
with ultrasonic welds, adhesive, deformable features, or other
mechanisms.
[0222] FIG. 23A is a lateral view of an alternative embodiment of
the invention drawn in FIG. 21A. The suture-holding device 1520 has
a base 1522 with posts 1525 having slots 1524. The posts 1525 are
oriented generally perpendicular to the base 1522. The slots 1524
are used to hold the ends of sutures. The base 1522 of the device
is preferably covered with an adhesive component.
[0223] FIG. 23B is view of the top of the embodiment of the
invention drawn in FIG. 23A and portions of two sutures. The
sutures are held in the slots 1524 of the device 1520. The sutures
or the device adjacent to the slots 1524 are preferably reversibly
deformable to facilitate the press-fit of the sutures into the
device. The invention is designed to temporarily hold the sutures
without injuring the sutures. The device 1520 is preferably made of
a radiolucent polymer such as an elastomer.
[0224] Although the foregoing invention has, for the purposes of
clarity and understanding, been described in some detail by way of
illustration and example, it will be obvious that certain changes
and modifications may be practiced which will still fall within the
scope of the appended claims.
* * * * *