U.S. patent application number 12/787386 was filed with the patent office on 2010-09-16 for systems and methods for removing body tissue.
Invention is credited to Jason Blain, Matthew Curran, Eric Kovach, Chester Sutterlin, Troy Woolley.
Application Number | 20100234848 12/787386 |
Document ID | / |
Family ID | 31989878 |
Filed Date | 2010-09-16 |
United States Patent
Application |
20100234848 |
Kind Code |
A1 |
Sutterlin; Chester ; et
al. |
September 16, 2010 |
Systems and Methods for Removing Body Tissue
Abstract
Devices and methods for removing body tissue involving the use
of a brush member having a plurality of bristle members defining a
capacity for carrying body tissue. The brush member is capable of
being manipulated within said body to thereby receive body tissue
within said brush member such that said body tissue may be carried
and thereafter removed from said body. Also provided are protective
devices dimensioned to be positioned near an entrance into the
target site, the protective devices for establishing a barrier
between the brush member and at least a portion of the body tissue
adjacent to the entrance. The protective devices may comprise one
of a cannula assembly and a retractor assembly.
Inventors: |
Sutterlin; Chester;
(Gainesville, FL) ; Blain; Jason; (San Diego,
CA) ; Curran; Matthew; (San Diego, CA) ;
Woolley; Troy; (San Diego, CA) ; Kovach; Eric;
(Carlsbad, CA) |
Correspondence
Address: |
NuVasive;c/o CPA Global
P.O. Box 52050
Minneapolis
MN
55402
US
|
Family ID: |
31989878 |
Appl. No.: |
12/787386 |
Filed: |
May 25, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10527538 |
Mar 11, 2005 |
7722613 |
|
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PCT/US02/28926 |
Sep 11, 2002 |
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12787386 |
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Current U.S.
Class: |
606/79 |
Current CPC
Class: |
A61B 2017/00261
20130101; A61B 2090/036 20160201; A61B 2017/0256 20130101; A46B
3/18 20130101; A61B 2017/00362 20130101; A61B 17/025 20130101; A61B
17/1675 20130101; A61B 17/1671 20130101; A61B 17/0206 20130101;
A61B 50/33 20160201; A61B 17/02 20130101; A61B 2017/320012
20130101; A61B 17/3207 20130101; A61B 2017/00477 20130101; A61B
17/16 20130101; A61B 2017/2837 20130101; A61B 17/320708
20130101 |
Class at
Publication: |
606/79 |
International
Class: |
A61B 17/16 20060101
A61B017/16 |
Claims
1. A system for removing intervertebral disc material, comprising:
a protector having a longitudinal axis and including first and
second generally rectangular, planar blade members fixed in
position relative to one another to form a generally V-shaped
construct for establishing a barrier, said construct having a
longitudinal axis extending in a generally parallel orientation
relative to said longitudinal axis of said protector; and a brush
member having a plurality of bristle members defining a capacity
for carrying intervertebral disc material, wherein said protector
is configured to prevent contact between said brush member, said
neural tissue and said at least one of dura tissue and
vasculature.
2. The system of claim 1, wherein said protector further comprises
a cannula dimensioned to extend to said entrance of said
intervertebral disc space, said cannula having an inner lumen
dimensioned to slideably receive said brush member for passage into
said intervertebral disc space.
3. The system of claim 2, wherein said cannula includes a lip
member at a distal end thereof dimensioned to retract at least one
of said neural tissue, dura tissue, and vasculature adjacent to
said spine.
4. The system of claim 2, wherein said inner lumen of said cannula
and said brush member have approximately the same cross-sectional
shape.
5. The system of claim 1, wherein said brush member includes a stem
member, and wherein said system further includes a drive assembly
capable of engaging with said stem member for manipulating said
brush member within said intervertebral disc space.
6. The system of claim 5, wherein said drive assembly comprises one
of a powered drive assembly coupled to said stem member and a
manual drive assembly coupled to said stem member.
7. The system of claim 6, wherein said powered drive assembly is a
power drill.
8. The system of claim 6, wherein said manual drive assembly
includes a handle member configured to couple to said stem
member.
9. The system of claim 6, wherein said drive assembly includes a
stop member coupled to said stem member for controlling the depth
to which said brush member can be advanced into said intervertebral
disc space.
10. A method for removing intervertebral disc material, comprising
the steps of: creating a working channel from a patient's skin to
an intervertebral disc space; advancing a protector through said
working channel toward said intervertebral disc space, said
protector having a longitudinal axis and including first and second
generally rectangular, planar blade members fixed in position
relative to one another to form a generally V-shaped construct for
establishing a barrier, said construct having a longitudinal axis
extending in a generally parallel orientation relative to said
longitudinal axis of said protector; positioning said protector
near an entrance into said intervertebral disc space between said
working channel and at least two of neural tissue, dura tissue, and
vasculature adjacent to said entrance such that said first blade
member prevents neural tissue from migrating into said working
channel, and said second blade member prevents at least one of dura
tissue and vasculature from migrating into said channel; inserting
a brush member through the working channel into said intervertebral
disc space, said brush member having a plurality of bristle members
defining a capacity for carrying intervertebral disc material,
wherein said protector prevents contact between said brush member,
said neural tissue and said at least one of dura tissue and
vasculature; manipulating said brush member within said
intervertebral disc space to receive intervertebral disc material
within said brush member; and removing said brush member from said
intervertebral disc space.
11. The method of claim 10, wherein said step of creating a working
channel to the intervertebral disc space is accomplished via at
least one of percutaneous surgical procedure and an open surgical
procedure.
12. The method of claim 10, wherein said protector further
comprises a cannula dimensioned to extend to said entrance of said
intervertebral disc space, said cannula having an inner lumen
dimensioned to slideably receive said brush member for passage into
said intervertebral disc space.
13. The method of claim 12, wherein said cannula includes a lip
member at a distal end thereof dimensioned to retract at least one
of said neural tissue, dura tissue, and vasculature adjacent to
said spine.
14. The method of claim 12, wherein said inner lumen of said
cannula and said brush member have approximately the same
cross-sectional shape.
15. The method of claim 10, wherein said brush member includes a
stem member, and further including the step of providing a drive
assembly capable of engaging with said stem member for manipulating
said brush member within said intervertebral disc space.
16. The method of claim 15, wherein said drive assembly comprises
one of a powered drive assembly coupled to said stem member and a
manual drive assembly coupled to said stem member.
17. The method of claim 16, wherein said powered drive assembly is
a power drill.
18. The method of claim 16, wherein said manual drive assembly
includes a handle member capable of being coupled to said stem
member.
19. The method of claim 18, wherein said manual drive assembly
includes an extension member coupled to said handle and a
quick-connect coupling assembly for releasable connection to said
stem member.
20. The method of claim 16, wherein said drive assembly includes a
stop member coupled to said stem member for controlling the depth
to which said brush member can be advanced into said intervertebral
disc space.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of U.S. application Ser.
No. 10/527,538, filed Mar. 11, 2005, which is a 371(c) application
of PCT/US02/28926, filed Sep. 11, 2002, the entire contents of
which are hereby expressly incorporated by reference into this
disclosure as if set forth fully herein.
BACKGROUND OF THE INVENTION
[0002] I. Field of the Invention
[0003] This invention relates to devices and methods for removing
body tissue. More particularly, the present invention relates to
devices and methods for removing body tissue involving the use of a
brush or brush-like element capable of collecting, carrying, or
otherwise receiving body tissue for removal.
[0004] II. Discussion of the Prior Art
[0005] A large variety of pathologies affecting many different body
tissues indicate the use of tissue ablation (i.e., removal or
destruction of a tissue). Examples of such procedures include knee
meniscectomy, knee synovectomy, chondromalacia and tears, loose
body debridement, lateral retinacular release, plica removal,
ligament and tendon release, contouring and sculpting of articular
surfaces, debridement of inflamed synovial tissue, capsulectomy in
the knee, complete or partial resection of internal organs, tumors
and lesions.
[0006] Tissue ablation can be accomplished using many different
ways, the two main categories consisting of mechanical and energy
focusing means. Mechanical tools are used to cut away the targeted
tissue. Thermal energy has also been used which heats the targeted
tissue until the cells die. Lasers, radiofrequency waves,
microwaves, ultrasound, and cryotherapy have all been used in
thermal techniques. In a related technique, an electrical current
is used to excite a fluid, creating a plasma layer. The highly
energized plasma layer then incrementally disintegrates layers of
the tissue.
[0007] The existing techniques suffer from a host of disadvantages.
Typically, mechanical devices are small and remove tissue in very
small increments. As a result, when large amounts of tissue must be
removed the excision time may be exorbitant. The energy focusing
techniques, in addition to suffering from the time disadvantage of
the mechanical devices, are further limited. The energy levels
applied to the tissue must be conservatively regulated to avoid
damaging tissue beyond the targeted tissue.
[0008] One procedure, in particular, that is hindered by the
existing devices and techniques is a spinal discectomy (i.e.,
removal of intervertebral disc material). Each disk is composed of
an annulus fibrosus, a nucleus pulposus, and a pair of end caps
which couple the annulus fibrosus and nucleus pulposus. The annulus
fibrosus is an annular multi-layered composite structure. Each
layer is constructed of fibrous tissue and fibrocartilage with the
fibers of each layer ordered and oriented generally in the same
direction. The fibers of adjacent layers pass in opposite
directions so that when the layers are combined they create a mesh
of concentric rings. The central cavity of the annulus houses the
nucleus pulposus, which is a semi-gelatinous, highly elastic
material. The final components are end caps constructed of thin
layers of hyaline cartilage that cover both the top and bottom of
each spinal disk. The end caps cover both the annulus fibrosus and
the nucleus pulposus and assure that the nucleus pulposus remains
within the confines of the annulus fibrosus.
[0009] Oftentimes, disks become herniated, or bulge, due to
structural damage to the annulus fibrosus. The bulging disk may
place pressure on nearby nerves, which can lead to debilitating
pain, numbness or muscle weakness. Treatments used to reduce the
affects of a damaged disk range from bed rest to spinal fusion. Due
to the major shortcomings of those extreme treatments they are
often not desirable. A discectomy, either full or partial, can help
to balance the burdens and benefits of bed rest and fusion or help
prepare the intervertebral site for procedures like fusion.
[0010] When a partial discectomy is performed, a portion of the
nucleus pulposus of a herniated disc is excised. Partially removing
the nucleus material can reduce the pressure exerted by the nucleus
on the annulus and reduce the bulging. In this procedure, the
surgeon must first make an appropriate incision through the skin
and other tissue layers, and then typically create an access hole
through the herniated annulus (i.e., an annulotomy) to treat the
offending tissue. Such access holes are created with a variety of
surgical instruments including scalpels, probes, trephines, etc.,
and the access hole may range in size from 3 to 6 mm in
diameter.
[0011] Upon entry into the interior annular space, the surgeon
removes the offending tissue. The tools typically used are only
able to remove small portions of tissue with each approach. As a
result, removal of the tissue during a discectomy can take an
exorbitant amount of time. In addition, in some cases, when
ablation of the verterbral body surfaces adjacent to the disc is
required, an additional tool must be used adding additional time
and steps to the procedure. The additional time requirement of this
procedure gives rise to a need for tools and methods for performing
rapid discectomy and end plate ablation.
[0012] The present invention is directed at addressing this need
and eliminating, or at least reducing, the effects of the
shortcomings of the prior art systems as described above.
SUMMARY OF THE INVENTION
[0013] The present invention overcomes the drawbacks of the prior
art by providing, according to a first broad aspect of the present
invention, a device for removing body tissue comprising a brush
member dimensioned for introduction into a body. The brush member
has a plurality of bristle members defining a capacity for carrying
body tissue. The brush member is capable of being manipulated
within the body to thereby receive body tissue within the brush
member such that the body tissue may be carried and thereafter
removed from the body.
[0014] In a further aspect of this device, the capacity for
carrying body tissue is defined by at least one of the space
between the bristle members and the space between groupings of the
bristle members. The bristle members may be grouped to define at
least one generally helical space for receiving and carrying body
tissue therein, at least one generally axial space for receiving
and carrying body tissue therein, and/or at least one generally
arcuate space for receiving and carrying body tissue therein.
[0015] In another aspect, the bristle members may be disposed in a
generally solid configuration with spacing sufficient to receive
and carry body tissue between said bristle members. In a further
aspect, the brush member has at least one of a generally
cylindrical, generally elliptical, and generally polygonal
cross-sectional shape. The bristle members may comprise one of
metal and plastic and, more particularly, at least one of stainless
steel wire, carbon-tempered steel wire, non-ferrous wire, and
synthetic wire. The bristle members may be generally cylindrical in
cross-section with a diameter from 0.002 to 0.100 inches.
[0016] According to certain aspects, the brush member may be
generally cylindrical with a diameter from 0.082 to 1.225 inches.
The brush member may also include a stem member extending therefrom
for use in manipulating the brush member within said body. In a
further aspect, the stem member may be generally cylindrical with a
diameter from 0.125 to 0.250 inches. The stem member may also be
equipped with a quick-connect coupling for engaging with at least
one of a handle member and an extension member. In a further
aspect, at least a portion of the bristle members may be
retractable within the stem member. The stem member may have a
length of from 1 to 24 inches and may include depth indicia.
[0017] Among the host of possible applications, the brush member
may, according to a further broad aspect, be dimensioned to be
introduced into an intervertebral space to receive, carry, and
remove intervertebral disc material. In particular, the brush
member may be used to remove intervertebral disc material in order
to thereafter introduce a spinal implant into the intervertebral
space. In another related aspect, the brush member may be
dimensioned to be introduced into a vertebral body to receive,
carry, and remove osseous material.
[0018] The present invention overcomes the drawbacks of the prior
art by providing, according to a second broad aspect of the present
invention, a system for removing body tissue comprising a brush
member of the type described above in combination with a protector
dimensioned to be positioned near an entrance into a target site.
The protector establishes a barrier between the brush member and at
least a portion of the body tissue adjacent to the entrance. The
brush member and protector may be employed to remove body tissue
during at least one of a percutaneous surgical procedure and an
open surgical procedure.
[0019] In one further aspect, the protector comprises a cannula
dimensioned to extend to the entrance of the target site, wherein
the cannula has an inner lumen dimensioned to slideably receive the
brush member for passage into the target site. The cannula may
include a handle member for directing the cannula to the entrance
of the target site. In one aspect, the inner lumen of the cannula
and the brush member have approximately the same cross-sectional
shape
[0020] According to a further embodiment, the brush member includes
a stem member, and the system further includes a drive assembly
capable of engaging with the stem member for manipulating the brush
member within the target site. The drive assembly may comprise one
of a powered drive assembly coupled to the stem member and a manual
drive assembly coupled to the stem member. The powered drive
assembly may comprise a power drill. The manual drive assembly may
include a handle member capable of being coupled to the stem member
and, in a further embodiment, may include an extension member
coupled to the handle and a quick-connect coupling assembly for
releasable connection to the stem member. In either case (powered
or manual), the drive assembly may include a stop member coupled to
the stem member for controlling the depth to which the brush member
can be advanced into the target site.
[0021] According to one aspect of the system, the body tissue
adjacent to the entrance may include at least one of neural tissue,
dura tissue, and vasculature adjacent to the spine. If so, the
cannula may include a lip member at a distal end thereof
dimensioned to retract at least one of the neural tissue, dura
tissue, and vasculature.
[0022] In yet another aspect of the system of the present
invention, the protector comprises a retractor having at least one
blade member for establishing a barrier between the brush member
and the body tissue adjacent to the entrance to the target site.
The body tissue adjacent to the entrance may include at least one
of neural tissue and dura tissue of the spine. If so, the retractor
may includes a first blade member for retracting the neural tissue
and a second blade member for retracting the dura tissue. The first
blade member and second blade member may have a fixed or variable
angle therebetween. In the latter case, the retractor may include a
handle assembly for varying the angle between the first blade
member and the second blade member.
[0023] Among the host of applications of the system of the present
invention, the brush member may, according to a further broad
aspect, be dimensioned to be introduced into the intervertebral
space to receive, carry, and remove intervertebral disc material.
In particular, the brush member may be used to remove
intervertebral disc material in order to thereafter introduce a
spinal implant into the intervertebral space. In another related
aspect, the brush member may be dimensioned to be introduced into a
vertebral body to receive, carry, and remove osseous material.
[0024] The present invention overcomes the drawbacks of the prior
art by providing, according to a third broad aspect of the present
invention, a method for removing body tissue, comprising the steps
of: (a) creating a working channel from a patient's skin to a
surgical target site (via percutaneous and/or open techniques); (b)
inserting a brush member of the type set forth above into the
surgical target site, the brush member having a plurality of
bristle members defining a capacity for carrying body tissue; (c)
manipulating the brush member within the body to receive body
tissue within the brush member; and (d) removing the brush member
from the surgical target site.
[0025] According to various aspects, the surgical target site may
be an intervertebral disc space, and the step of inserting a brush
member may include, prior to the step of inserting the brush
member, positioning a protector near an entrance into the
intervertebral disc space for establishing a barrier between the
brush member and at least one of neural tissue, dura tissue, and
vasculature adjacent to the entrance. The protector may comprise a
cannula of the type described above and/or retractor (fixed or
variable angle) of the type described above.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] Other objects and advantages of the invention will become
apparent upon reading the following detailed description and upon
reference to the drawings in which:
[0027] FIG. 1 is a perspective view of a system for removing body
tissue according to one broad aspect of the present invention;
[0028] FIG. 2 is a side view of a cannula assembly forming part of
the system for removing body tissue shown in FIG. 1;
[0029] FIGS. 3 and 4 are side and end views, respectively, of a
brush member and adapter member forming part of the tissue removal
system of FIG. 1;
[0030] FIG. 5 is a side view of an extension member forming part of
the tissue removal system shown in FIG. 1;
[0031] FIGS. 6 and 7 are perspective and cross-sectional views,
respectively, of a stopper assembly forming part of the tissue
removal system shown in FIG. 1;
[0032] FIGS. 8 and 9 are side and top views, respectively, of the
tissue removal system of FIG. 1 in use performing a discectomy;
[0033] FIGS. 10 and 11 are perspective and side views,
respectively, of a retractor forming an alternate aspect of the
tissue removal system shown in FIG. 1 (without the cannula assembly
14);
[0034] FIG. 12 is a perspective view of a fixed angle tissue
retractor according to one embodiment of the present invention;
[0035] FIG. 13 is a perspective view of a variable angle tissue
retractor according to further embodiment of the present
invention;
[0036] FIGS. 14 and 15 are top views showing the variable angle
tissue retractor of FIG. 13 with the blade members generally closed
(FIG. 14) and generally open (FIG. 15);
[0037] FIGS. 16 and 17 are top views of trays forming a kit
according to one embodiment of the present invention;
[0038] FIGS. 18-23 are side views showing various alternate
configurations of the brush member according to the present
invention;
[0039] FIG. 24 are cross-sectional views illustrating several
manners of providing the brush member;
[0040] FIG. 25 is a top view of an alternate brush member
configuration, disposed long a curved stem member; and
[0041] FIG. 26 is a top view of an alternate embodiment having
multiple brush members and multiple stem members.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0042] Illustrative embodiments of the invention are described
below. In the interest of clarity, not all features of an actual
implementation are described in this specification. It will of
course be appreciated that in the development of any such actual
embodiment, numerous implementation-specific decisions must be made
to achieve the developers' specific goals, such as compliance with
system-related and business-related constraints, which will vary
from one implementation to another. Moreover, it will be
appreciated that such a development effort might be complex and
time-consuming, but would nevertheless be a routine undertaking for
those of ordinary skill in the art having the benefit of this
disclosure. The systems disclosed herein boast a variety of
inventive features and components that warrant patent protection,
both individually and in combination.
[0043] The present invention overcomes the shortcomings of tissue
ablation techniques of the prior art by employing a brush member
having a plurality of bristle members defining a capacity for
carrying body tissue. The capacity for carrying body tissue is
based on the spacing between the individual bristle members and/or
the spacing between one or more groups of bristle members. While
the present invention is described below within the context of
removing body tissue relating to the spine (i.e. intervertebral
disc material and/or osseous material), it is to be readily
appreciated that the present invention may be used in any number of
different medical procedures. These may include, but are not
necessarily limited to, knee meniscectomy, knee synovectomy,
chondromalacia and tears, loose body debridement, lateral
retinacular release, plica removal, ligament and tendon release,
contouring and sculpting of articular surfaces, debridement of
inflamed synovial tissue, capsulectomy in the knee, complete or
partial resection of internal organs, tumors and lesions. As used
herein, the term "body tissue" includes any tissue present in a
living or dead body, including but not limited to tissue involved
in the aforementioned list of medical procedures (including
intervertebral disc material, cancellous and cortical bone, and
fatty tissues).
[0044] FIG. 1 illustrates a system 10 for removing body tissue
according to a first broad aspect of the present invention. The
system 10 includes a brush member 12 and a cannula assembly 14.
Although described immediately below within the context of use with
the cannula assembly 14, it is to be understood at the outset that
the brush member 12 (including all the variations shown and
described herein--and their equivalents) forms an independently
patentable aspect of the present invention. As will be described in
greater particularity below, this is based on the primary feature
of providing the brush member 12 having a plurality of bristle
members defining a capacity for carrying body tissue, wherein the
brush member 12 is capable of being manipulated within the body to
thereby receive body tissue within the brush member 12 such that
the body tissue may be carried and thereafter removed from the
body. The capacity for carrying body tissue is defined by at least
one of the space between the individual bristle members forming the
brush member 12 and the space between groupings of bristle members
forming the brush member 12.
[0045] With combined reference to FIGS. 1-2, the cannula assembly
14 includes a cannula member 16 and a handle member 18. The cannula
member 16 has an inner lumen 20 dimensioned to pass the brush
member 12 therethrough en route to a surgical target site within a
body. In one aspect of the present invention, the surgical target
site may be one of the intervertebral disc space and an
intravertebral body space. Importantly, the distal end of the
cannula member 16 (opposite the handle member 18) serves to form a
protective barrier between the brush member 12 and tissues adjacent
to the surgical target site. Within the context of spinal
applications, such tissues may include, but are not necessarily
limited to, neural structures (i.e. exiting nerve roots) and dura
tissue (during posterior and/or postero-lateral access to the
spine) and vasculature (during anterior access to the spine). To
further protect against inadvertent contact with such adjacent
tissues (including pinching such structures), the cannula assembly
14 is equipped a lip member 22 capable of preventing such tissues
from migrating into the distal opening of the cannula 16.
[0046] With reference to FIGS. 1 and 3-4, the brush member 12 is
provided, by way of example only, having its bristles disposed in a
dual spiral or helical grouping 24 along a stem member 26. This
helical configuration 24 of the bristles creates a generally
helical space 28 extending along the length (L.sub.B) of the brush
member 12. This helical space 28, along with the space between the
individual bristles forming the helical grouping 24, defines a
carrying capacity within the brush member 12 for the removal of
body tissue. In a preferred embodiment, the length (L.sub.B) of the
brush member 12 may range from 0.25 to 4.0 inches and the diameter
(D.sub.B) of the brush member 12 may range from 0.082 to 1.225
inches.
[0047] The bristles may be constructed from a number of materials
that have sufficient strength to avoid shedding or dislodging of
the bristles from the stem 26 during use and of proven safety in
medical applications. Such bristle materials may include, by way of
example, metal and plastic and, more particularly, stainless steel
wire, carbon-tempered steel wire, non-ferrous wire, and synthetic
materials (such as nylon or other plastics). In a preferred
embodiment, the individual bristles are generally cylindrical, each
having a diameter ranging from 0.002 to 0.100 inches. Although not
shown, the bristles may also be provided having a square or other
polygonal cross-section (depending on the method of
manufacture--which may include drawing, extrusion or molding)
without departing from the scope of the present invention.
[0048] The stem member 26 is a generally rigid member that extends,
according to one embodiment, away from the brush member 12 for
connection to a quick-connect adapter 30. The stem member 26 may be
provided having a diameter (D.sub.s) ranging from 0.125 to 0.250
inches and a length ranging from 1 to 24 inches. The quick-connect
adapter 30 enables the stem member 26 to be quickly coupled or
de-coupled from a manual drive assembly 32 to be described below.
The quick connect adapter 30 is generally cylindrical with a
connector portion 34 on its proximal end. The distal end of the
quick connect adapter 30 may be coupled to the stem member 26 by
crimping or by any mechanical connection that provides sufficient
strength to withstand torsional forces during rotation of the brush
member 12. The male connector portion 34 includes a flat surface 34
that provides a bearing surface that transmits rotation between the
brush member 12 and the manual drive assembly 32, and a concentric
channel 53 that is engaged by a retractable feature in a mating
device that prevents axial movement between the quick connect
adapter 30 and the a mating device. It should be appreciated that
there are many known connection mechanisms that may be substituted
without departing from the scope of the present invention,
including but not limited to a Jacob's adapter.
[0049] Turning to FIGS. 1 and 5, the manual drive assembly 32
includes, by way of example, an extension adapter 40 having a
female quick-connect collet 42 at its distal end and a male
connecting portion 44 at its proximal end. The female quick connect
collet 42 is of known construction and functions to couple the
extension adapter 40 to the quick-connect adapter 30. The male
connecting portion 44 is of similar construction to the
corresponding connecting portion 34 of the quick connect adapter 30
and, as such, need not be described again here, except to point out
that the connecting portion 44 of the extension adapter 40 is, in a
preferred embodiment, to be coupled to a manual handle (not shown)
such that a surgeon may impart rotational force on the brush member
12 to effectuate the tissue removal of the present invention.
According to an alternate embodiment, the connecting portion 44 may
be coupled to a power drill (thus forming a powered drive mechanism
according to the present invention).
[0050] The extension adapter 40 may be provided with certain depth
management features to control or manage the extent to which the
brush member 12 is introduced into the target surgical site. In one
embodiment, these depth management features may include indicia 46
disposed along the length of the extension adapter 40 (denoting, by
way of example, a depth ranging from 0 to 50 mm) and a plurality of
notches 48. These depth management features are particularly suited
for use with a stopper assembly 50 shown generally in FIG. 1 and in
detail in FIGS. 6-7.
[0051] The stopper assembly 50 includes a stop member 52, a detent
member 54, a spring 56, and a locking pin 58. The stop member 52
includes an aperture 60 dimensioned to receive the extension member
40, as well as a side aperture 62 for receiving the detent member
54. The detent member 54 includes a locking pin slot 64, an
engagement aperture 66, and an extension 68. The slot 64 allows the
locking pin 58 to travel therein to control the inward and outward
travel of the detent member 54 within the stop member 52. The
aperture 66 includes an enlarged region 70 and an engagement ridge
72 (hence the "semi-constrained" terminology). When the detent 54
is pushed into the stop member 52 (by urging against the spring
56), the enlarged region 70 is moved into general coaxial alignment
with the aperture 60 such that the extension adapter 40 may be
passed through the stop member 52. Once positioned at a desired
location along the notched region 48 of the extension adapter 40,
the detent member 54 may be released such that the engagement ridge
72 will be disposed within one of the notches 48 and thereby
restrict the movement of the extension adapter 40 relative to the
stop member 52. In a preferred embodiment, the stop member 52 does
not restrict either rotation of the brush member 12 or translation
in the proximal direction. As a result, the brush member 12 is
limited to a depth that can be predetermined while still allowing
rotation and limited back and forth motion.
[0052] With reference to FIGS. 8-9, the tissue removal system 10
will now be described, by way of example only, in use within in the
context of a discectomy procedure despite its general utility in
any of a variety of tissue removal procedures. First, a working
channel is formed between the patient's skin and the surgical
target site, which in this case is an intervertebral disc space.
The working channel be created via a traditional "open" techniques
or a percutaneous or "minimal access" technique. With the working
channel created, the cannula 16 may be inserted such that its
distal end (with the lip member 22) is disposed adjacent to or in
the generally proximity of the annulus. In a preferred embodiment,
the lip member 22 may be used to prevent any surrounding tissue
(such as exiting nerve roots and/or dura tissue in the case of the
posterolateral approach shown best in FIG. 9) from migrating into
the distal opening of the cannula 16. An annulotomy device of known
construction may be extended to the disc through the cannula 16 to
remove a section of the disc annulus.
[0053] Thereafter, the discectomy brush 12 may be extended into the
disc nucleus via the cannula 16 and disc annulus. The brush member
12 may then be rotated, manually or by power means such as a drill,
to remove disc material. Depending on the diameter of the brush
member 12 and the distance between the adjacent vertebrae, the
discectomy brush 12 may be used to remove tissue as well as ablate
or partially decorticate the surfaces of the adjacent vertebrae.
The brush member 12 may then be removed and may be discarded or
cleaned depending on the brush material. In one embodiment, the
brush is comprised of plastic and another of stainless steel.
[0054] After removal of such disc material and, optionally,
preparation of the vertebral endplates, any of a variety of spinal
implants may be inserted into the space created by the discectomy
brush. These spinal implants may include, but are not necessarily
limited to, allograft products, ceramic spacers, and total disc
replacement devices. Whatever the implant, it should ideally be
inserted into this space via the cannula 16. The annulus opening
may then be closed (through any known means, such as sutures or
patch devices or sealing compounds) and then the cannula 16
removed. It should be readily understood that anterior, extreme
lateral, posterolateral or posterior approaches may be utilized
using the principles of the present invention.
[0055] FIGS. 10-11 illustrate another broad aspect of the present
invention, wherein a retractor 80 is provided (as opposed to the
cannula assembly 16 described above) for the purpose of
establishing a protective barrier between the brush member 12 and
the tissues adjacent to the surgical target site (again, the
intervertebral disc space). To accomplish this, the retractor 80
provides a pair of retractor blade 82, 84, which collectively form
a generally "V" shaped construct capable of preventing the exiting
nerve root (via blade 82) and the dura tissue (via blade 84) from
migrating into a region that might otherwise result in the unwanted
contact between the brush member 12 and these tissues. To
facilitate this, each blade member 82, 84 is preferably equipped
with a lip member 83 similar to lip member 22 of the cannula 16. As
shown in FIG. 12, these blade members 82, 84 may be positioned
relative to the surgical target site by virtue of an elongate
curved shaft 86 coupled to a handle member 88. In one embodiment,
the blade members 82, 84 have a fixed angle relative to one another
ranging from between 50 and 75 degrees.
[0056] In an alternate embodiment shown in FIGS. 13-15, the
retractor 80 may have blade members 82, 84 that are variable angle
relative to one another. To accomplish this, a handle assembly 90
is provided having a pair of gripping elements 92, 94 which, upon
manipulation towards (FIG. 14) and away (FIG. 15) from one another
serve to increase and decrease, respectively, the angle between the
blade members 82, 84. A shaft 85 extends between the gripping
elements 92, 94 for independently coupling the blade members 82, 84
to one of the gripping elements 92, 94. A locking feature may be
optionally be provided by equipping the first gripping element 92
with an arcuate, ribbed engagement element 96 which cooperates with
a trigger member 98 coupled to the second gripping element 94. A
spring 100 is disposed between the gripping elements 92, 94 and
over a portion of the engagement element 96 to aid in the locking
and unlocking of the handle assembly 90. In one embodiment, the
angle between the blade members 82, 84 may be varied between 0 and
180 degrees and, more preferably, 0 to 90 degrees. The ability to
close the angle between the blades 82, 84 (that is, to an angle of
approximately 0 to 30 degrees) is helpful in that it may aid in
placing the blades 82, 84 in proper position to form the barrier
between the surrounding tissue and the brush member 12, such as by
being introduced in the closed or reduced angle and thereafter
opening the blades 82, 84 to thereby more gently move the adjacent
structures aside.
[0057] With reference to FIGS. 16-17, the tissue removal system 10
of the present invention may be provided in any number of suitable
fashions, including the kit fashion shown comprising a first tray
110 and a second tray 112. By way of example only, the tray 110 may
be provided having a plurality of brush members 12 of varying size
and length to accommodate the particular surgical need or
procedure. Tray 110 may also include components of the given drive
mechanism, such as a pair of extension members 40 (for coupling to
the quick coupling adapters 30 attached to the brush members 12), a
pair of stopper assemblies 50, a handle assembly 51 (for
quick-connect coupling to the extension member 40), and a pair of
retractors 80 (in this embodiment, the fixed angle configuration).
Tray 112 may include a plurality of cannula assemblies 14 having
cannulas 16 with inner lumens having the same or similar diameters
as the brush members 12 contained in tray 110. Providing the tissue
removal system 10 of the present invention in this fashion is
convenient and offers significant time savings and flexibility in
tailoring the system 10 depending upon the given surgical
procedures.
[0058] As mentioned above, the brush member 12 forms an independent
and significant feature of the present invention based on its
capacity to carry body tissue both within the bristles of the
brush, as well as between the groupings of bristles. Although shown
above with reference to a dual spiral configuration, it is to be
readily appreciated that the brush member 12 may be provided in any
number of suitable fashions without departing from the scope of the
present invention. For example, the brush member 12 may be provided
having a single spiral bristle grouping 24 (see FIG. 18) defining a
generally helical space 28 for receiving and carrying body tissue,
a generally solid configuration (see FIG. 19) wherein the bristles
have sufficient spacing therebetween to receive and carry body
tissue, one or more radially extending bristle groupings 24 (FIGS.
20-21) defining at least one generally arcuate space 28 for
receiving and carrying body tissue, and one or more axially
disposed bristle groupings 24 (FIGS. 22-23) defining at least one
generally axial space 28 for receiving and carrying body tissue.
Moreover, the cross-sectional shape of the brush member 12 may vary
from the generally circular cross-section of the cylindrical brush
member 12 shown above, to any of a variety of polygonal
cross-sections, including but not limited to those shown in FIG.
24.
[0059] In a further aspect of the present invention, it is
contemplated that the bristles forming the brush member 12 may be
retractable toward the stem member 26 allowing for the brush
diameter to be increased after insertion into the material to be
excised. That feature may be accomplished by construction of the
brush portion 11 from a material such as Nitinol or other "memory
metal" or through a mechanical or electro-mechanical mechanism. It
is similarly contemplated to (as shown in FIG. 25) provide the
brush member 12 formed along a curved (or possibly rounded) stem
member 26 for manual or automated manipulation within the target
site (such as back-and-forth and/or side-to-side), as well as (as
shown in FIG. 26) provide a plurality of brush members 12, each
having a stem member 26 capable of independent manipulation (such
as via rotation) and/or unison operation (moving the entire
configuration back-and-forth and/or side-to-side) to effectuate
body tissue removal.
[0060] While the invention is susceptible to various modifications
and alternative forms, specific embodiments thereof have been shown
by way of example in the drawings and are herein described in
detail. It should be understood, however, that the description
herein of specific embodiments is not intended to limit the
invention to the particular forms disclosed, but on the contrary,
the invention is to cover all modifications, equivalents, and
alternatives falling within the spirit and scope of the invention
as defined by the appended claims.
* * * * *