U.S. patent application number 12/790103 was filed with the patent office on 2010-11-25 for methods for delivering an implant and agent in an intervertebral disc.
This patent application is currently assigned to Intrinsic Therapeutics, Inc.. Invention is credited to Bogomir Gorensek, Sean Kavanaugh, Gregory H. Lambrecht, Robert Kevin Moore.
Application Number | 20100298837 12/790103 |
Document ID | / |
Family ID | 33539281 |
Filed Date | 2010-11-25 |
United States Patent
Application |
20100298837 |
Kind Code |
A1 |
Gorensek; Bogomir ; et
al. |
November 25, 2010 |
METHODS FOR DELIVERING AN IMPLANT AND AGENT IN AN INTERVERTEBRAL
DISC
Abstract
The present invention relates generally to devices and methods
for delivering medical devices, such as implants, to desired tissue
sites, such as the intervertebral disc. In one aspect, an
intervertebral disc repair and diagnostic device that is minimally
invasive and that provides precise access to the desired site is
provided. In some aspects, the device and method are adapted to
deliver, position and expand implants that are initially oriented
and compressed for minimally invasive, yet precise and effective
implantation.
Inventors: |
Gorensek; Bogomir;
(Ljubljana, SI) ; Lambrecht; Gregory H.; (Natick,
MA) ; Kavanaugh; Sean; (Eastham, MA) ; Moore;
Robert Kevin; (Natick, MA) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET, FOURTEENTH FLOOR
IRVINE
CA
92614
US
|
Assignee: |
Intrinsic Therapeutics,
Inc.
Woburn
MA
|
Family ID: |
33539281 |
Appl. No.: |
12/790103 |
Filed: |
May 28, 2010 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10873073 |
Jun 21, 2004 |
7727241 |
|
|
12790103 |
|
|
|
|
60480276 |
Jun 20, 2003 |
|
|
|
Current U.S.
Class: |
606/99 |
Current CPC
Class: |
A61F 2002/4627 20130101;
A61F 2/4611 20130101; A61F 2002/4435 20130101 |
Class at
Publication: |
606/99 |
International
Class: |
A61B 17/58 20060101
A61B017/58 |
Claims
1. A method of delivering and positioning an implant and a
therapeutic agent within an intervertebral disc comprising:
providing a delivery device, wherein said delivery device comprises
a cannula, one or more lumens, a depth stop and an advancer
slideably retained within the cannula, wherein the advancer is
configured to advance an implant coupled to the distal end of the
advancer out of said cannula; compressing said implant along a
first axis; inserting said cannula into an intervertebral disc;
positioning said depth stop to abut against an external surface of
the intervertebral disc and delivering said implant relative to
said position; positioning said cannula such that the implant is
positioned beyond the innermost surface of the anulus; rotating the
cannula, thereby rotating the implant; retracting the cannula,
thereby initially expanding the implant to a first partially
expanded configuration; delivering one or more agents through the
one or more lumens into the intervertebral disc, wherein said agent
is at least one of a pharmaceutical agent or a nucleus augmentation
material; uncoupling the implant from the distal end of the
advancer; and removing the delivery device from the intervertebral
disc.
2. The method of claim 1, further comprising: advancing one or more
expanders coupled to a distal end of the cannula, thereby further
expanding the implant to a second partially expanded configuration;
and advancing the thereby substantially completely expanding the
implant to a fully expanded configuration.
3. The method of claim 1, further comprising aspirating material
through at least one of the one or more lumens.
4. The method of claim 1, wherein the pharmaceutical agent
comprises one or more growth factors.
5. The method of claim 1, wherein the pharmaceutical agent
comprises an anti-inflammatory agent, a steroid, or an
antibiotic.
6. The method of claim 1, wherein the pharmaceutical agent
comprises a vasodilator or a vasoconstrictor.
7. The method of claim 1, wherein the pharmaceutical agent
comprises a fluid to aid in heating or cooling the site tissue.
8. The method of claim 1, wherein the pharmaceutical agent is
configured to facilitate pain reduction or inhibition of
scarring.
9. The method of claim 1, wherein the pharmaceutical agent
comprises genetically active growth or healing factors.
10. The method of claim 1, wherein the delivery device comprises a
lubrication to reduce friction as the implant exits the delivery
device.
11. The method of claim 1, wherein the pharmaceutical agent is
configured to stimulate tissue ingrowth.
12. The method of claim 1, wherein the one or more agents are
delivered before inserting the cannula within the intervertebral
disc.
13. The method of claim 1, wherein the one or more agents are
delivered after uncoupling the implant from the distal end of the
advancer.
14. The method of claim 1, wherein the implant comprises a
graft.
15. The method of claim 1, wherein the delivery device comprises
one or more anchoring mechanisms.
16. The method of claim 1, further comprising anchoring the implant
to adjacent or nearby tissue of the intervertebral disc.
17. The method of claim 1, further comprising adjusting a
temperature of surrounding tissue.
18. The method of claim 1, wherein the implant is expanded
inferiorly and superiorly with respect to vertebral endplates
adjacent the intervertebral disc.
19. The method of claim 1, wherein the implant is expanded along a
direction substantially parallel to a vertebral endplate adjacent
the intervertebral disc.
20. The method of claim 1, further comprising the step of inserting
the implant through a defect or iatrogenic hole.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of co-pending U.S.
application Ser. No. 10/873,073, filed Jun. 21, 2004, which claims
priority under 35 U.S.C. .sctn.119(e) to U.S. Provisional Appl. No.
60/480,276, filed Jun. 20, 2003, the entire contents of each of
which are herein incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates generally to devices and
methods for delivering implants to an intervertebral disc.
Specifically, in some embodiments, apparatus and methods for
delivering implants that are oriented and compressed for minimally
invasive, yet precise and effective implantation are provided.
[0004] 2. Description of the Related Art
[0005] Various implants, surgical meshes, patches, barriers, tissue
scaffolds and the like may be used to treat intervertebral discs
and are known in the art. Surgical repair meshes are used
throughout the body to treat and repair damaged tissue structures
such as intralinguinal hernias, herniated discs and to close
iatrogenic holes and incisions as may occur elsewhere. Certain
physiological environments present challenges to precise and
minimally invasive delivery.
[0006] An intervertebral disc provides a dynamic environment that
produces high loads and pressures. Typically, implants designed for
this environment, unless used for temporary purposes, must be
capable of enduring such conditions for long periods of time. Also,
the difficulty and danger of the implantation procedure itself, due
to the proximity of the spinal cord, limits the size and ease of
placement of the implant. In light of the inherent limitations
involved with delivery of medical devices to the disc environment,
such devices should preferably be delivered precisely with respect
to the location of the defect.
SUMMARY OF THE INVENTION
[0007] In one embodiment of the present invention, devices and
methods for delivering implants to an intervertebral disc are
provided. In a preferred embodiment, delivery methods are designed
to prevent or reduce exacerbation of the existing defect or
iatrogenic hole. One of skill in the art will understand that
several embodiments of the invention can be used to deliver
implants, or other medical devices, to sites in the body other than
the intervertebral disc. For example, several embodiments of the
invention can be used to deliver medical devices (such as implants)
into the heart, bladder, liver, cranium, vertebrae, femur and other
bones
[0008] In one embodiment, a method of delivering and positioning a
medical device (such as an implant) within an intervertebral disc
is provided. In one embodiment, the method comprises providing a
cannula, an advancer, one or more expanders and an implant. The
advancer is at least partially coupled to, slideably engaged to, or
housed within the cannula. The advancer is coupled to an implant,
or is operable to be coupled to an implant. The implant is operable
to exhibit a compressed profile along one or more axes. The method
further comprises compressing the implant along a first axis, and
inserting the cannula into a interverterbral disc. The method
further comprises positioning the cannula in the disc such that the
implant is positioned beyond the innermost surface of the anulus,
rotating the cannula or advancer, retracting the cannula, thereby
initially expanding the implant, advancing one or more expanders,
thereby further expanding the implant, advancing the cannula,
thereby substantially completely expanding the implant, uncoupling
the implant from the advancer, and removing the cannula and the
advancer from the disc. In one embodiment, the cannula or advancer
is rotated clockwise or counterclockwise to enable the implant to
be rotate in a range from about 80 degrees to about 120 degrees.
Preferably the implant is rotated about 90 degrees. In other
embodiments, the above steps are performed using a medical device
other than an implant. In some embodiments, the medical device
(such as an implant) is delivered to a site other than the disc.
These sites include, but are not limited to, the heart, cranium or
femur. In one embodiment, one or more depth stops are coupled to
the cannula, advancer, or delivered as a separate component. In one
embodiment, when the cannula is inserted into the disc, the depth
stop is placed at a position adjacent an external surface of an
intervertebral disc and the implant is delivered relative to that
position.
[0009] In one embodiment, the step of compressing the implant
comprises folding the implant. In other embodiments, compressing
the implant comprises folding, deflating, compacting, compressing,
closing or condensing the implant, or a combination thereof.
[0010] In one embodiment, the step of expanding the implant
comprises unfolding the implant. In other embodiments, expanding
the implant comprises unfolding, inflating, enlarging, swelling, or
opening the implant, or a combination thereof.
[0011] In one embodiment, the implant is a barrier or patch.
Implants suitable for implantation according to one or more
embodiments of the invention include the implants described in U.S.
Pat. Nos. 6,425,919, 6,482,235, and 6,508,839, all herein
incorporated by reference.
[0012] In a further embodiments, one or more implants are inserted
through a defect or iatrogenic hole.
[0013] In one embodiment, a method of delivering a medical device
(such as an implant) within an intervertebral disc is provided. In
one embodiment, the method comprises providing an implant that is
capable of exhibiting a compressed profile along one or more axes,
compressing the implant along a first axis, inserting the implant
within an intervertebral disc along a second axis and beyond the
innermost lamella of an anulus lamella, rotating the implant about
an axis perpendicular to the second axis; and causing or allowing
the implant to transform from a compressed profile to an expanded
profile.
[0014] In another embodiment, a method of delivering a medical
device (such as an implant) within an intervertebral disc comprises
providing a delivery device having an elongate implant advancer
carried within or alongside an elongate sleeve. In one embodiment,
the advancer is releasably coupled to an implant, wherein the
implant is compressed within the sleeve at a distal end of the
sleeve. The method further comprises advancing the distal end of
the sleeve with an intervertebral disc along a first axis, rotating
the advancer, releasing the implant from the sleeve thereby
decompressing the implant, and releasing the implant from the
advancer.
[0015] In a further embodiment, a method of delivering a medical
device (such as an implant) in an intervertebral disc wherein the
disc has a defect or iatrogenic hole forming a void in the anulus
of the disc is provided. In one embodiment, the method comprises
providing a compressible implant having a first and second axis,
compressing an implant along a first axis, orienting the implant to
such that the short axis of the compressed implant presents a
profile the is smaller than the largest dimension of the void,
inserting the implant beyond the defect or iatrogenic hole,
rotating the implant clockwise or counterclockwise about ninety
degrees, causing or allowing the implant to expand or unfold, and
retracting at least a portion of the implant against an inner
surface of the anulus.
[0016] In yet another embodiment, a method of delivering a medical
device (such as an implant) in an intervertebral disc along an
innermost surface of an anulus of the disc is provided. In one
embodiment, the method comprises inserting the implant through and
beyond the innermost surface of the anulus, retracting the implant
toward the innermost surface of the anulus, and deflecting at least
a portion of the implant against the innermost surface of the
anulus, thereby causing the implant to advance laterally along said
surface.
[0017] In yet another embodiment, a method of delivering a medical
device (such as an implant) in an intervertebral disc along an
innermost surface of an anulus of the disc is provided. In one
embodiment, the method comprises inserting the implant within the
disc and beyond the innermost surface of the anulus, retracting the
implant toward the innermost surface of the anulus, and deflecting
at least a portion of the implant against the innermost surface of
the anulus, thereby causing the implant to advance laterally along
said surface. In one embodiment, the implant is expanded. In some
embodiments, the method further comprises simultaneously retracting
and deflecting the implant. In sever embodiments, the method
further comprises simultaneously retracting and deflecting the
implant in a synchronized manner. In a preferred embodiment, the
method comprises rotating the implant.
[0018] In one embodiment of the invention, a device for delivering
and positioning an implant within an intervertebral disc is
provided. In one embodiment, the device comprises a cannula and an
advancer. In one embodiment, the cannula has a proximal end and a
distal end, wherein the distal end comprises one or more expanders
operable to expand an implant positioned beyond the innermost
lamella of a disc anulus. In one embodiment, the advancer has a
proximal end and a distal end, wherein the advancer is positioned
at least partially within the cannula. The distal end of the
advancer comprises a coupling mechanism, wherein the coupling
mechanism is coupled to the advancer and to the implant. In another
embodiment, the expanders are not located on the cannula, but
instead coupled to the advancer. In one embodiment, the expanders
are located on a separate instrument. In one embodiment, the device
comprises one or more depth stops. The depth stop can be coupled to
any portion of the cannula or advancer, or can be independently
delivered. In one embodiment, the depth stop is operable to limit
and/or guide travel within the intervertebral disc. In a further
embodiment, the depth stop is rotatably coupled to the cannula,
thereby allowing it to rotate while the depth of the cannula is
maintained.
[0019] In one embodiment, the advancer is advanced through a sheath
or other constraining means, and no cannula is used. In another
embodiment, the advancer is coupled to a constraining means at its
distal end that is operable to constrain the implant until the
implant reaches the desired site (such as a site located beyond the
innermost lamella of the anulus).
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] FIGS. 1A-1C show disc anatomy. FIGS. 1A and 1B show the
general anatomy of a functional spinal unit. FIG. 1A is a view of a
transverse section of a functional spinal unit. FIG. 1B is a view
of a sagittal section. FIG. 1C shows the same functional spine unit
with a defect in the anulus, which may have been created
iatrogenically, as in the performance of an anulotomy, or may be
naturally occurring.
[0021] FIGS. 2A-2D are front views of a delivery device and its
elements in accordance with an embodiment of the present
invention.
[0022] FIGS. 3A-3E show embodiments of a delivery device. FIG. 3A
is an isometric view of another delivery device in accordance with
an embodiment of the present invention. FIG. 3B is an isometric
view of the above delivery device loaded with an implant folded in
place at the slotted distal end of the cannula. FIG. 3C is an
isometric view of the above delivery device loaded with an implant
in an unfolded configuration. FIG. 3D is an isometric partial view
of the distal end of a delivery device loaded with a folded
implant. FIG. 3E is a cross-sectional partial view of the distal
end of an unloaded delivery device showing the implant coupling
member.
[0023] FIGS. 4A-4B show aspects of the disc. FIG. 4A is a side view
of a functional spinal unit showing a defect in the posterior
anulus of the disc. FIG. 4B is a side view of a functional spinal
unit showing a delivery device inserted within the disc.
[0024] FIGS. 5A-5G illustrate one method of delivering an implant
according to one embodiment of the invention. FIG. 5A is an axial
view of the cross-section of an intervertebral disc with a delivery
device inserted within the disc.
[0025] FIG. 6 is an axial view of the cross-section of an
intervertebral disc showing an implant situated along the posterior
of the anulus and implanted relative to a defect.
[0026] FIGS. 7A-7D show aspects of the implant. FIG. 7A shows an
implant compressible along two axes which can be used with various
embodiments of the invention. FIG. 7B is a top view (as it would be
viewed along the superior-inferior axis of a vertebral in its
implanted orientation) of an implant and lateral extensions or
stabilizers. FIG. 7C shows the same implant folded or compressed in
an accordion like manner to facilitate loading into the cannula.
FIG. 7D is an isometric view of another implant suitable for use
with some embodiments of the invention having a concavity along its
length and extensions.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0027] Several embodiments of the invention will be discussed
herein through the demonstration of its use in the spine, with
particular emphasis on intervertebral disc treatment. One of skill
in the art will certain understand that several embodiments of the
invention can be used to access or treat other sites in the
body.
[0028] FIGS. 1A and 1B show the general anatomy of a functional
spine unit. In this description and the following claims, the terms
`anterior` and `posterior`, `superior` and `inferior` are defined
by their standard usage in anatomy, e.g., anterior is a direction
toward the front (ventral) side of the body or organ, posterior is
a direction toward the back (dorsal) side of the body or organ;
superior is upward (toward the head) and inferior is lower (toward
the feet).
[0029] FIG. 1A is an axial view along the transverse axis M of a
vertebral body with the intervertebral disc 315 superior to the
vertebral body. Axis M shows the anterior (A) and posterior (P)
orientation of the functional spine unit within the anatomy. The
intervertebral disc 315 contains the anulus fibrosus (AF) 310 which
surrounds a central nucleus pulposus (NP) 320. Also shown in this
figure are the left 370 and right 370' transverse spinous processes
and the posterior spinous process 380.
[0030] FIG. 1B is a sagittal section along sagittal axis N through
the midline of two adjacent vertebral bodies 350 (superior) and
350' (inferior). Intervertebral disc space 355 is formed between
the two vertebral bodies and contains intervertebral disc 315,
which supports and cushions the vertebral bodies and permits
movement of the two vertebral bodies with respect to each other and
other adjacent functional spine units.
[0031] Intervertebral disc 315 is comprised of the outer AF 310,
which normally surrounds and constrains the NP 320 to be wholly
within the borders of the intervertebral disc space. Axis M extends
between the anterior (A) and posterior (P) of the functional spine
unit. The vertebrae also include facet joints 360 and the superior
390 and inferior 390' pedicle that form the neural foramen 395. The
facet joints and intervertebral disc translate motion and transfer
load between the adjacent vertebral bodies. This complex
biomechanical arrangement allows for flexion, extension, lateral
bending, compression, and can withstand intense axial loading and
bending cycles of around a million per year. The disc height can
vary from 50% to 200% of its resting value.
[0032] FIG. 1C shows the same functional spine unit with a defect
in the anulus, which may have been created iatrogenically, as in
the performance of an anulotomy, or may be naturally occurring.
Such a defect can be repaired, in one embodiment, using a surgical
mesh or therapeutic mesh, or the like. In one embodiment, the mesh
can be impregnated or coated with therapeutic agents or drugs to
regrow or otherwise stimulate healing or growth or ingrowth as
described herein.
[0033] In one embodiment of the invention, a method and device
capable of delivering a therapeutic implant in a minimally invasive
manner is provided. In a preferred embodiment, delivery provides
accurate and precise placement of the implant, while still being
minimally invasive. In one embodiment, the implant is placed along
a tissue surface in an expanded or manipulated configuration and
orientation that differs from the insertion configuration and
orientation.
[0034] In several embodiments, methods and apparatuses for
delivering surgical meshes, barriers, patches, or the like, for
treatment or augmentation of tissues within pathologic spinal discs
and other structures are provided. In one embodiment, a dynamic and
synergistic delivery method and device that allow for an integrated
re-orientation, expansion and delivery of an implant in a confined
and limiting environment is provided.
[0035] According to one embodiment, an instrument designed to
assist in the delivery and positioning of a implant within or
adjacent to the various tissues generic to intervertebral disc,
including the vertebral bodies and their endplates, the anulus
fibrosis, the nucleus pulposus, and the surrounding ligaments, is
provided.
[0036] One advantage of several embodiments of the invention are
particularly advantageous because, in some indications, a
practitioner has to deliver an implant or other medical device that
has a complicated configuration. For example, some implants have
one or more dimensions in their implanted or deployed state that
make it difficult or impossible to insert due, for example, to
physiological size or geometrical constraints. Such implants may
have a second dimension which is also larger than the allowed
dimensions available for insertion. For example, the height of the
implant may be greater than the height of the opening or anulotomy
or the height of the space between the adjacent endplates at their
periphery. Further, the length of some implants may also be larger
than the width anulotomy.
[0037] In one embodiment, an instrument and method that can
effectively deliver medical devices to a desired site is provided.
The method is particularly advantageous for delivering medical
devices having challenging configurations. In one embodiment, the
method comprises first inserting the implant rotated relative to
the limiting dimension to achieve a diminished or compatible
profile and then rotating the implant back to the desired
orientation and expanded during final positioning. In a preferred
embodiment, this method is accomplished using a single instrument.
Other embodiments comprise using two or more compatible
instruments.
[0038] In one embodiment of the invention, a delivery device
comprising a cannula, a proximal end and a distal end is provided.
In one embodiment, the elongated, hollow cannula or sleeve has a
proximal end for handling by a physician and a distal end for
inserting within a patient is provided. The distal end of the
cannula can be dimensioned to fit within a small anulotomy as might
be created by a surgeon or through a naturally occurring hole or
lesion in the anulus.
[0039] In a further embodiment, an implant guide or advancer is
carried within the cannula or sleeve. In one embodiment, the guide
or advancer is releasably coupled to an implant that may be
compressed within the cannula along one or more axes. In one
embodiment, the guide or advancer is axially moveable within the
cannula and can rotate depending on the implant used or
implantation site selected. The cannula functions as a guide for
the axial reciprocal movement the advancer. As such, in one
embodiment, the cannula can, therefore, be provided in the form of
an elongate tube having a central lumen for receiving advancer
therethrough. Alternatively, the cannula can comprise a nontubular
structure or simply a sleeve or partial restraining member in an
embodiment in which the advancer travels concentrically over or
alongside it.
[0040] In one embodiment, a substantially rectangular implant is
provided. In several embodiments, the implant is a mesh comprised
of nitinol, steel, or polymer, or a combination thereof. In other
embodiment, the implant comprises a seeded or unseeded tissue
scaffold, such as collagen or small intestine sub mucosa, and the
like.
[0041] In one embodiment, the implant can be folded across its long
axis, connected to the advancer, and inserted within the sleeve at
the distal end of the delivery device. If the fold created along
the short axis is larger that the sleeve diameter then one or more
slots can be formed at the tip of the sleeve to accept the implant.
Alternatively, the implant can be compressed along the second or
short axis of the implant so that both dimensions are held
compressed within the sleeve. One of skill in the art will
understand the implant, if needed, can be compressed along any axis
in accordance with several embodiments of the invention.
Compressing the implant (or medical device), as used herein, shall
be given its ordinary meaning and shall also include folding,
deflating, compacting, compressing and condensing the implant or
medical device.
[0042] In one embodiment, in use, the distal end of the sleeve is
inserted into the desired organ or tissue structure, such as an
intervertebral disc. The implant is loaded into the sleeve such
that the fold is at or near the distal end of the sleeve. Depending
on the shape of the insertion site (e.g., a rectangular anulotomy),
and its orientation (vertical or horizontal), the implant or
advancer can be rotated in order to pass through the aperture
regardless of the desired implantation orientation. Accordingly,
devices according to one or more embodiments of the invention can
cause the implant to rotate between around 5 and 150 degrees and
preferably between around 60 and 120 degrees. In one embodiment, at
least a portion of the delivery device is rotated clockwise or
counterclockwise in the range of between about 2 to 170 degrees,
preferably between about 50 to 140 degrees, more preferably about
80 to 120 degrees, thereby enabling rotation of the implant. In one
embodiment, the device or the implant is rotated about 90
degrees.
[0043] In one embodiment, as the sleeve loaded with the compressed
implant is inserted medially into the disc, the surgeon may stop
inserting when the edges of the folded-over implant pass beyond the
corresponding tissue surface against which implantation is desired.
In this example, the surgeon would stop after passing the anulus or
the outer and more narrow gap between the periphery of the adjacent
vertebral endplates. Thereafter, the implant can be rotated about
an axis perpendicular to the insertion axis to correspond to the
desired insertion orientation. Next, the sleeve is retracted
relative to the advancer to reveal the folded (and now unrestrained
or actively compressed) implant. Depending on the orientation of
the implant within the sleeve (after the rotation step), the
implant will expand inferiorly and superiorly with respect to the
endplates or laterally to the left and right along the anulus. In
one embodiment, as the implant unfolds due to its inherent
resilience, or by a force imparted by the coupling member or
cannula, or by active manipulation by the physician, the advancer
is then retracted such that the folded part of the implant is
pulled posteriorly in the direction of the posterior anulus and the
sides or extensions of the implant advance laterally or travel
along the anulus surface. When the action of the advancer causes
the implant to be fully retracted flat along the tissue surface or
is otherwise in its fully expanded position then the surgeon may
detach the implant from the advancer.
[0044] One of ordinary skill in the art will understand the
kinematics, order, relative position, and orientation of the
implant, sleeve, and advancer can be reversed or altered to achieve
similar or equivalent results for a given implantation according to
several embodiments to the invention. For example, in one
embodiment, the advancer can be used to extrude the implant out
from the sleeve. In another embodiment, the sleeve can be retracted
relative to the advancer. In a further embodiment, the advancer can
be retracted to pull the implant posteriorly and along the
posterior anulus or alternatively, the whole device (including the
sleeve or cannula and advancer) can be pulled back. Both the
advancer and the sleeve independently or the device itself can be
used to rotate the implant. In one embodiment, at least a portion
of the device remains stationary while one or more of its elements
are manipulated. In another embodiment the delivery device is
simplified with the use of a constraining member used in place of
the sleeve to hold the implant in a compressed state at the distal
end of the advancer. For example a suture, clamp, ring, band,
pincher, or an adhesive could be used to constrain the implant and
then the advancer could still server to advance the implant within
the disc and rotate it into position.
[0045] In several embodiments, parts of the device can serve
different purposes during steps of the implantation. In one
embodiment, the sleeve can constrain and then release the folded or
compressed implant and later, when the implant is released and in a
slightly expanded state (larger that the profile of the cannula
opening or tip), the cannula can be advanced (or the advancer can
be retracted) such that the cannula or sleeve tip contacts the
inside surface of the folded sides of the implant and forces them
to open. Accordingly, in one embodiment, the retracting step
involving posterior movement of the midsection of the implant and
lateral movement of the sides of the implant along the anulus
surface caused by the opposing force of the anulus causing lateral
deflection may be unnecessary since the opposing and synchronized
action and relative motion of the advancer and cannula tip
effectively act like a lever and fulcrum to open, expand or unfold
the implant. In one embodiment, the connector at the fold or hinge
of the implant acts like a fulcrum and the distal tips of the
cannula act like levers to push the fold flat and open the implant.
This alternative or complimentary step or method of opening may be
particularly useful in expanding the implant proximal to a large
defect of weakened portion of the anulus since such tissue might
not offer a solid deflection surface for the opposing ends of the
implant to advance along.
[0046] FIGS. 2A-2D show one embodiment of the invention. A delivery
device 10 is shown having an elongate cannula having a proximal end
1 and distal end 2. The cannula 15 has a distal end tip 20 or ends
20, 20' formed by a slot 21 cut into its distal end 2 for accepting
and constraining a compressed implant 100. Also shown are the
cannula finger handles 5, 5', advancer 30, advancer ring handle 25
at the proximal end 1 and implant/advancer coupling member 35 at
the distal end 2 of the device.
[0047] In one embodiment, a coupling member 35 is used. The
coupling member 35 is any device or mechanism that is capable of
attaching or connecting the implant in reversible manner. Coupling
members include, but are not limited to, sutures, snaps, locks,
lynch pins or the like, levers and slots, or any active or passive
linking mechanism known in the art that would permit a surgeon to
disengage the implant at the desired point of the procedure. In one
embodiment, one or more coupling members are used. In one
embodiment, two coupling members are used to connect the
implant.
[0048] In one embodiment, the device 10 is designed to be operated
by one hand, e.g., utilizing the thumb, index, and ring fingers to
position the device 10 and advance and retract the advancer 30.
However, one skilled in the art will understand that any of a
variety of proximal handpieces can alternatively be used,
including, but not limited to, triggers, slider switches, rotatable
knobs or other actuators to advance and retract the advancer
30.
[0049] In one embodiment, the delivery device 10 can be
manufactured in accordance with any of a variety of techniques well
known in the medical device arts. In one embodiment, the cannula 15
comprises a metal tube such as stainless steel or other medical
grade metal. Alternatively, the device 10 can comprise a polymeric
extrusion, such as high density polyethylene, PTFE, PEEK, PEBAX, or
others well known in the medical device arts.
[0050] In a preferred embodiment, the axial length of the delivery
device 10 is sufficient to reach the desired treatment site from a
percutaneous or small incision access through the skin. In one
embodiment, the length of the delivery device 10 is within the
range of about 10 centimeters to about 30 centimeters with a length
from a proximal end to distal end within the range of about 10 to
about 20 centimeters contemplated for most posterior lateral access
pathways. The length can be varied depending upon the intended
access pathway and patient size.
[0051] In one embodiment, the outside diameter of the delivery
device 10, and the distal end of the cannula 15, is no greater than
necessary to accomplish the intended functions disclosed herein. In
one embodiment, outside diameters of less than about one centimeter
are preferred. In preferred embodiments of the present invention,
the cannula 15 has an outside diameter of no greater than
approximately 5 millimeters.
[0052] An exemplary embodiment having additional features is
presented in FIGS. 3A-3E. FIG. 3A is an isometric view of an
implant delivery device 200 having a proximal end 1 for
manipulating by a surgeon and a distal end for inserting with a
patient. In one embodiment, an implant advancer or guide 130 having
a handle 125 located at the proximal end 1 of the device 200 and an
implant coupling member 135 extending to the distal end 2 of the
device 200 is provided. The advancer 130 is slideably housed within
a cannula 115 which has a cannula handle 105 for positioning and
controlling the cannula.
[0053] The device, in one embodiment, also includes a distal depth
stop 150 feature that provides a limit and guide to the
anterior/posterior positioning of the implant during implantation
and in the final positioning of the implant. The depth stop 150 and
150' is carried by the cannula 115 and can be adjusted to rest
along certain points of its length by manipulating the depth stop
adjustment member 155 and holding the depth stop handle 160. A
calibrated measuring surface 156 can be etched onto to the cannula
or attached separately to the cannula as a sleeve to display depth
correlations. Alternatively, non adjustable depth stops in a
variety of lengths can be included as a kit and the precise depth
stop for a given procedure can be selected preoperatively. In one
embodiment, the depth stop 150 can be coupled to the cannula such
that free rotation of the cannula 115 and advancer 130 are possible
while maintaining the desired depth of the distal tip of the
device.
[0054] In a further embodiment, to assist opening or expanding the
implant, an implant expander 170 having a wedge surface(s) 175,
175' at its distal end an expander handle 140 attached at its
proximal end is carried within the cannula 115 and over or along
each side of the advancer 130. One or more expanders can be coupled
to the cannula or the advancer. In one embodiment, a separate
instrument comprising one or more expanders at its distal end is
passed through the cannula.
[0055] In FIG. 3B, a delivery device according to one embodiment of
the invention is shown loaded with a compressed implant 100 at the
distal end 2 of the device 200. As shown, in one embodiment, the
rectangular implant 100 is folded over itself across its longs axis
and fitted within a slot of the cannula formed by the slotted ends
of the cannula 120 and 120'. In an alternative embodiment, the
cannula could be straight (e.g., no slot formation) and the implant
could also be compressed along its second or short axis. FIG. 3C
shows the device coupled to an expanded or unfolded implant
100.
[0056] FIG. 3D shows an enlarged isometric view of the distal end
of the device 200 loaded with an implant 100 between slotted end
tips or tongs 120, 120' of the cannula 115. The opposing distal
ends of the depth stop 150, 150' are shown as forked protrusions
adjacent the cannula 115. In one embodiment, two depth stops are
provided. In another embodiment, one or more depth stops are
provided. In an alternative embodiment, an entire circumferential
stop surface can be used.
[0057] FIG. 3E shows the cross-section of the distal end of the
device 200 including the expanders 175, 175' and implant/advancer
coupling member 135. In one embodiment, the coupling member is a
flexible "T-bar" attached lengthwise to the advancer 130 and fits
into slots in the implant surface (not shown). Alternatively,
active and passive coupling means described above can also be used.
In one embodiment, when the expanded implant is retracted against
the tip of the cannula 120 and/or the anulus surface (which is
shown oversized in comparison to the mouth of the cannula or
insertion site), further retraction of the advancer or the device
its causes the coupling member to slip out of the slots (not shown)
in the implant. Also shown are radio opaque indicators 150, 150'
coupled to the depth stop 150, 150' which can be used in
determining device placement during radiographic imaging. For
example, portions of the device can be aligned with anatomical
structures or the handles or other projections of the device can be
oriented to correspond to the implants orientation. One or more
radio opaque markers can be used in one embodiment of the
invention. One of skill in the art will understand that other
indicators or markers can also be used. Turning to FIGS. 4A and 4B,
a side view of a functional spinal unit is shown with a defect 300
in the anulus 310 (see e.g., FIGS. 1A-1C for vertebral anatomy) and
the device 200 inserted in the defect. In one embodiment, a
posterior lateral approach that can involve a laminotomy or
modification of the posterior elements of the adjacent vertebral
bodies is used. In a further embodiment, other approaches can be
used, including, but not limited to, anterior (e.g., through the
abdomen or neck), lateral (e.g., transpsoas), or inferior (e.g.,
trans-sacral) approaches.
[0058] The series presented in FIGS. 5A through 5G depict a
sequence for delivering a generally elongate rectangular mesh
implant according to an embodiment of the method. The defect 300 or
box or slit anulotomy is rectangular in shape having a lateral (or
width) dimension greater than its vertical dimension. Moreover, the
vertical dimension may also be limited by the relative location of
the endplates at the time of procedure limiting the height of a
deliverable implant. In one embodiment, the implant 200 is
oversized to cover the defect 300 and to function as a barrier
situated against the anulus 310 along its innermost lamella.
[0059] FIG. 5A is an axial view of a cross-section of the disc
showing the implant 100 folded along its long axis and connected to
the advancer 130 (not shown) and inserted within the distal end
tips or tongs 120 of the cannula 115. Here, the fold created along
the short axis is larger that the cannula 115 diameter so a slot is
formed at the tip of the cannula 115 formed by opposing tips 120,
(120' not shown). This arrangement permits the distal end of the
device 2 loaded with the implant to be advanced within and then
beyond the defect 300 and the anulus 310 as shown in FIG. 5B. Here
the depth stop 150, 150', 150'' is shown as three protrusions
though more or less can be used. In this delivery application,
portions of the depth stop 150 can be placed against the anulus or
one or both of the adjacent vertebral bodies. In other embodiments,
the depth stop 150 can be placed on, abut or engage the exterior of
an organ, such as the heart, a bone such as cranium, femur, or
vertebral body. In one embodiment, the implant is designed to have
a preferred region of final placement in terms of its positioning
toward the anterior or posterior of the disc (anterior being
defined as the direction toward the front of the patient and
posterior being defined as the direction toward the back of the
patient) in front of the defect. The surgeon may also want to place
the implant and have the delivery device provide a limit or guide
to the distance toward the anterior of the disc in order to prevent
damage to the anterior anulus or damage to anatomy anterior of the
disc such as the aorta. Similarly, the surgeon may want to place
the implant in a position that is not too far posterior within the
disc to prevent damage to the posterior anulus or anatomy posterior
to the disc such as the spinal cord and its dura mater or the
posterior longitudinal ligament.
[0060] FIG. 5C shows the next step in the aforementioned method
wherein the cannula 115 is rotated 90 degrees (after clearing the
anulus). FIG. 5D shows the implant already unfolding or otherwise
changing its transverse profile. In one embodiment, as shown, the
gap between the opposing ends of the implant 100 is increasing as
is the angle of the fold created at the implant/advancer coupling
member 135. As discussed earlier this initial unfolding can be the
product of a variety of factors including the inherent resiliency
of the implant 100 or the coupling member 135.
[0061] FIG. 5E shows the advancement of wedge-tipped expanders 175
which can aid or replace the initial unfolding step described
above. The expanders 175, in one embodiment, are wedge-tipped. In
other embodiments, the expanders can be shaped in any form that
permit sufficient contact with the implant to lever it open or
otherwise reconfigure it, including but not limited to flat or
rounded shapes. Additionally, other embodiments may include
expanders comprising balloons, springs, elastic members, or
mechanical linkages adapted to expand or reconfigure the
implant.
[0062] FIG. 5F shows the advancement of the cannula tip 120, 120'
to assist the expanders in opening the implant 100. In one
embodiment, advancer 130, expander 175, and implant 100 can be
retracted against the distal end of cannula 120 and implant 100.
Force between cannula tip 120 and implant 100 acts to expand
implant 100 while minimizing forces between implant 100 and the
annular wall. This retraction of implant 100, advancer 130, and
expander 175 can be done at a different rates or synchronized or to
different extents relative to the retraction of cannula 120 to
generate this force and/or open implant 100 to a greater or lesser
extent during retraction of implant 100. In one embodiment, this
opening step is particularly advantageous in instances where the
tissue surface upon which the implant is to be positioned in
weakened and would otherwise provide a poor deflection surface or
if the defect is large such as would allow the implant to be pulled
back through the defect instead.
[0063] FIG. 5G show the final steps of delivery, in one embodiment,
wherein the implant 100 is pulled towards the posterior of the
anulus 310 as the ends of the implant 100 are deflected and
advanced laterally along its inner surface. This posterior travel
can be caused when the advancer 130, cannula 120, and expander 175
are retracted in unison. At this point the coupling member 135 is
disengaged from the implant 100 and the device is removed from the
patient. Note that, in one embodiment that substantially throughout
the procedure the depth stop 150 maintains relative position so
that the surgeon is certain of the placement of the device along
the anulus surface. The retraction of the various elements of the
system can be coordinated relative to depth stop 150 to minimize
forces on surrounding tissues or optimize expansion or position of
implant 100 relative to defect 300. FIG. 6 shows a fully implanted
device 100 (this implant being sized to cover the entire posterior
anulus) and the blocked-off defect 300.
[0064] In several embodiments, relatively simple rectangular meshes
or patches are provided for implantation. In other embodiments,
more complex devices can be used, including, but not limited to
stents, grafts, arterial septal defect closure devices and the
like. FIG. 7A shows an elongated implant 700 with two vertical
extensions 702, 702' that can be oriented, folded, and expanded
according to the teachings of various embodiments of the invention.
FIG. 7B shows an implant with lateral extensions 704, 704' as might
be used to cover the posterior and lateral walls of an anulus. FIG.
7C shows the implant 700 exhibiting multiple folds along its long
axis to compress its delivery profile. Finally, FIG. 7D presents a
concave elongate member that has lateral extensions 704, 704' and
midline lateral extensions 706, 706'. This design also permits
folding and compression along one or more axes and can be delivered
according to the teachings herein.
[0065] As part of an implantation procedure according to one
embodiment of the invention, active and passive systems can be
incorporated into the delivery devices or the implants to aid the
in preparation of the delivery site or in manipulating the implant.
For instance, in one embodiment, a gas, liquid and/or solid
component can be added to the implant during positioning or after
positioning to further reshape the implant or adjust its size. In
some embodiments, the implant comprises one or more pharmaceutical
agents. The pharmaceutical agent can facilitate pain reduction or
inhibition of scarring, and can include genetically active growth
or healing factors. In a further embodiment, lubrication is
provided to reduce friction as the implant exits the delivery
device. One or more pharmaceutical agents can also be provided by
or through the cannula or advancer. In yet another embodiment,
materials that aid in the visualization of the implant are
provided, including, but not limited to, material for radio opaque
location through a radiograph. Visual markers can be located on the
implant and/or the delivery device.
[0066] In one embodiment, the implant can be anchored to adjacent
or nearby tissue and an anchoring mechanism, such as a stapler, can
be incorporated into the delivery device. In another embodiment, a
mechanism for activating an anchoring mechanism can be contained
within the implant itself. Heat, energy delivery from the
electromagnetic spectrum, or the removal of heat (chilling or
freezing) can be employed before, after or during the implant
deployment to aid in positioning, function of the implant, or
related disc or spine treatments such as the vaporization of
unwanted tissue, the deadening of pain receptors, and the removal
of bone or scar tissue. In one embodiment, means for adjusting the
temperature of surrounding tissue is coupled to or integral with
the delivery device. In another embodiment, means for adjusting
temperature is an instrument that is separate from the delivery
device.
[0067] In some embodiments, a delivery device comprises one or more
axially extending lumens, for placing the proximal end of the
device in fluid communication with the distal end, for any of a
variety of purposes. For example, one or more lumens can extend
through the advancer 130. Alternatively or in addition, the outside
diameter the advancer can be dimensioned smaller than the inside
diameter of the delivery cannula 115 to create an annular space as
is well understood in the catheter arts. A first lumen can be
utilized for introduction of radiopaque dye to facilitate
visualization of the progress of the implant 100 and or distal end
2 of the device 200 during the procedure. The first lumen or second
lumen can be utilized to introduce any of a variety of media. In
one embodiment, one or more lumens are used to deliver saline
solution. In another embodiment, one or more lumens are used to
deliver pharmaceutical agents, including but not limited to,
anti-inflammatory agents, steroids, growth factors (such as
TNf-.alpha. antagonists), antibiotics, vasodilators,
vasoconstrictors, and functional proteins and enzymes (such as
chymopapain). In one embodiment, one or more lumens is used to
aspirate material, such as biological fluids or nucleus pulposus.
In another embodiment, one or more lumens is used to introduce
nucleus augmentation material, or other biological or biocompatible
material, before, during or at the end of the procedure. In several
embodiments, one or more lumens are used to deliver fluid, or other
material, to a site to aid in heating or cooling the site
tissue.
[0068] While this invention has been particularly shown and
described with references to preferred embodiments thereof, it will
be understood by those skilled in the art that various changes in
form and details may be made therein without departing from the
scope of the invention encompassed by the appended claims. In
addition, one of skill in the art will understand that the steps
recited in some embodiments need not be performed sequentially or
in the order disclosed.
* * * * *