U.S. patent application number 16/589911 was filed with the patent office on 2020-02-06 for percutaneous transverse connector system.
The applicant listed for this patent is The University of Iowa Research Foundation. Invention is credited to Andrew Grossbach, Stephanus V. Viljoen.
Application Number | 20200038073 16/589911 |
Document ID | / |
Family ID | 53005119 |
Filed Date | 2020-02-06 |
United States Patent
Application |
20200038073 |
Kind Code |
A1 |
Viljoen; Stephanus V. ; et
al. |
February 6, 2020 |
Percutaneous Transverse Connector System
Abstract
A system and method for stabilizing a spine of an animal subject
involving a transverse rod installation instrument assembly for
inserting a transverse rod on the spine of a subject percutaneously
comprising: a first rod clamp extender mounted on a ipsilateral rod
clamp and a second rod clamp extender mounted on a contralateral
rod clamp wherein the ipsilateral rod clamp and the contralateral
rod clamp are secured to a vertebra at the ipsilateral and
contralateral pedicle; and a pivoting installation instrument
pivotably mounted to the first rod clamp extender and the second
rod clamp extender to pass a transverse rod percutaneously through
a head portion of the ipsilateral side rod clamp and to the head
portion of the contralateral rod clamp after passing through a
spinous process of the vertebra through pivot axis "A" such that
the transverse rod is secured at the head portion of the
ipsilateral rod clamp and the head portion of the contralateral rod
clamp.
Inventors: |
Viljoen; Stephanus V.;
(North Liberty, IA) ; Grossbach; Andrew; (Iowa
City, IA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
The University of Iowa Research Foundation |
lowa City |
IA |
US |
|
|
Family ID: |
53005119 |
Appl. No.: |
16/589911 |
Filed: |
October 1, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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15141745 |
Apr 28, 2016 |
10426528 |
|
|
16589911 |
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PCT/US2014/063152 |
Oct 30, 2014 |
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15141745 |
|
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61898332 |
Oct 31, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/7089 20130101;
A61B 17/7083 20130101; A61B 17/7076 20130101; A61B 17/7052
20130101; A61B 17/7043 20130101; A61B 17/7049 20130101; A61B
17/7085 20130101 |
International
Class: |
A61B 17/70 20060101
A61B017/70 |
Claims
1. An orthopedic clamp system for use with a rod for immobilizing
bone comprising: a rod clamp assembly having a clamp with an upper
surface and a lower surface and a rod receiving section positioned
superior to the clamp the rod receiving section having a pair of
opposing wings that extend from the rod receiving section, the
clamp including a tightening screw through its upper surface for
securing the clamp to a longitudinal rod immobilized to the bone
and a polyaxial head that is positioned between the rod receiving
section and the clamp.
2. The orthopedic clamp system of claim 1 wherein the polyaxial
head allows for freedom of movement when positioning a transverse
rod passer in the rod receiving section.
3. The orthopedic clamp system of claim 1 wherein the rod receiving
section is threaded to mate with a set screw to tighten a
transverse rod positioned in the rod receiving section.
4. The orthopedic clamp system of claim 1 wherein the pair of
opposing wings include a bolt on an outer surface of the pair of
opposing wings used to secure a docking ring of a rod clamp
extender when the rod clamp extender is positioned over the pair of
opposing wings.
5. The orthopedic clamp system of claim 1 wherein the pair of
opposing wings create an open space along the length "L" of the rod
clamp assembly which space permits a transverse rod receiving
section to be observed from above.
6. The orthopedic clamp system of claim 1 wherein the wings above
the rod receiving section are releaseably attached to the rod
receiving section.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a division of U.S. patent application
Ser. No. 15/141,745, entitled "Percutaneous Transverse Connector",
filed on Apr. 28, 2016, and issued on Oct. 1, 2019 as U.S. Pat. No.
10,426,528, which is a continuation of International Application
PCT/US14/63152, entitled "Percutaneous Transverse Connector
System", filed Oct. 30, 2014, which claims priority to and the
benefit of the filing of U.S. Provisional Patent Application No.
61/898,332, entitled "Percutaneous Transverse Connector System",
filed on Oct. 31, 2013, and the specification and claims thereof
are incorporated herein by reference.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] Not Applicable.
INCORPORATION BY REFERENCE OF MATERIAL SUBMITTED ON A COMPACT
DISC
[0003] Not Applicable.
COPYRIGHTED MATERIAL
[0004] Not Applicable.
BACKGROUND
[0005] The system and method of this invention relates to an
implantable spinal fixation system for the surgical treatment of
spinal disorders and apparatus for implantation.
[0006] Spinal column disorders such as scoliosis, kyphosis,
lordosis, spondylolisthesis, ruptured, broken, fractured or slipped
discs are treated with spinal fixation. Spinal fixation uses
surgical implants or constructs which mechanically immobilize the
treated area of the spine with the goal of causing the fusion of
the treated vertebrae. One type of spinal fixation utilizes a pair
of longitudinal rods that run parallel or longitudinally along the
spine and are affixed to pedicles of the appropriate vertebrae or
to the sacrum and act as anchor points for the longitudinal rods.
Bone screws are generally placed two per vertebrae with one at each
pedicle on either side of the spinous process of the vertebrae.
Clamp assemblies join the spine rods to the screws. When a pair of
transverse rod/connectors are fastened in parallel on either side
of the spinous process, the assembly can be significantly
strengthened. However, the instrumentation with transverse rods
described requires open surgery and a large incision. In doing so,
the skin and tissue surrounding the surgical site must be cut,
removed and or repositioned in order for the surgeon to access the
location where the stabilization device is to be installed. This
type of invasive surgery leads to risk of long recovery time,
disruption of muscle, trauma damage and scarring to the tissue.
[0007] In recent years minimally invasive spinal (MIS) procedures
have become more common. The advantages of MIS procedures compared
with open surgery are less pain, faster recovery, less
intra-operative blood loss, and generally greater patient
satisfaction. With the advent of innovative devices and techniques,
physicians now routinely perform MIS procedures that traditionally
would require open surgery. One of the shortcomings of MIS
procedure/surgery is the inability to place a transverse connector
through a percutaneous route. Transverse connectors are used during
spinal instrumentation procedures to add rigidity to the overall
construct offered by longitudinal rods alone. Transverse rods add
stability during axial rotation (twisting) and lateral bending
(side to side bending) of the spine. During open procedures the
placement of transverse connectors are straight forward but require
muscle dissection as well as other downsides mentioned herein.
[0008] Minimally invasive surgery wherein a long incision through a
muscle group such as those along the spine to expose multiple
levels of vertebrae is not required. Minimally invasive surgery may
be achieved with percutaneous minimally invasive spinal procedures
where minimal if any muscle dissection is required. Currently
minimally invasive surgery is not available to insert transverse
rods into the spine, for example, to add rigidity to an
instrumentation construct consisting of pedicle screws and
longitudinal rods involving multiple levels of vertebrae.
BRIEF DESCRIPTION OF THE INVENTION
[0009] One embodiment of the present invention provides a
transverse rod installation instrument assembly for inserting a
transverse rod on the spine of a subject percutaneously. A first
rod clamp extender is mounted on an ipsilateral rod clamp and a
second rod clamp extender is mounted on a contralateral rod clamp
wherein the ipsilateral rod clamp and the contralateral rod clamp
are secured to a vertebra at the ipsilateral and contralateral
pedicle. A pivoting installation instrument is pivotably mounted to
the first rod clamp extender and the second rod clamp extender to
pass a transverse rod percutaneously through a head portion of the
ipsilateral side rod clamp and to the head portion of the
contralateral rod clamp after passing through a spinous process of
the vertebra through pivot axis "A" path such that the transverse
rod is secured at the head portion of the ipsilateral rod clamp and
the head portion of the contralateral rod clamp. Further, the first
rod clamp extender has a cylinder with a pair of opposing arms that
extends superior to the cylinder wherein at the bottom of the
cylinder is a docking ring for engaging with the bolts on a pair of
opposing wings of the ipsilateral rod clamp assembly when the
cylinder of the first rod clamp extender is positioned over the
pair of opposing wings. The pair of opposing arms on the first rod
clamp extender includes a hole in each arm of the pair wherein the
hole in each arm of the pair of opposing arms aligns. The second
rod clamp extender has a cylinder with a pair of opposing arms that
extends superior to the cylinder wherein at the bottom of the
cylinder is a docking ring for engaging with the bolts on a pair of
opposing wings of the contralateral rod clamp assembly when the
cylinder of the second rod clamp extender is positioned over the
pair of opposing wings. The docking ring has an internal grove for
securing the bolt on the side of the wing of the rod clamp assembly
when the rod clamp assembly is in use to stabilize the extender
onto the rod clamp assembly. The pair of opposing arms on the
second rod clamp extender includes a hole in each arm of the pair
wherein the hole in each arm of the pair aligns. The first rod
clamp extender and the second rod clamp extender are secured
together with a bolt that fits through each hole in each arm of the
pair of opposing arms of the first rod clamp extender and each hole
in each arm of the pair of opposing arms of the second rod clamp
extender such that the bolt passes first through an arm of a first
rod clamp extender and then through an arm of the second rod clamp
extender before passing through the opposing arm of the first rod
clamp extender and then the opposing arm of the second rod clamp
extender. The pivoting installation instrument pivotably mounted to
the first rod clamp extender and the second rod clamp extender is
secured to the first rod clamp extender and the second rod clamp
extender via the bolt.
[0010] Another embodiment of the present invention provides for an
orthopedic clamp system for use with a rod for immobilizing bone
comprising a rod clamp assembly having a clamp with an upper
surface and a lower surface and a rod receiving section positioned
superior to the clamp the rod receiving section having a pair of
opposing wings that extend from the rod receiving section. The
clamp includes a tightening screw through its upper surface for
securing the clamp to a longitudinal rod immobilized to the bone
and a polyaxial head that is positioned between the rod receiving
section and the clamp. The polyaxial head allows for freedom of
movement when positioning a transverse rod passer in the rod
receiving section. The rod receiving section is threaded to mate
with a set screw to tighten a transverse rod positioned in the rod
receiving section. The pair of opposing wings include a bolt on an
outer surface of the pair of opposing wings used to secure a
docking ring of a rod clamp extender when the rod clamp extender is
positioned over the pair of opposing wings. The pair of opposing
wings create an open space along the length "L" of the rod clamp
assembly which space permits a transverse rod receiving section to
be observed from above. The wings above the rod receiving section
are releaseably attached to the rod receiving section.
[0011] Another embodiment of the present invention provides for a
method for inserting a transverse spinal rod into a patient
comprising attaching a first rod clamp assembly onto a first
longitudinal rod that is secured to a first vertebrae having a
first side of a spinous process of the patient wherein the first
rod clamp assembly is introduced to the longitudinal rod through a
first minimally invasive incision on the back of the patient at the
level of the first vertebrae. A second rod clamp is attached to the
assembly onto a second longitudinal rod that is secured to the
first vertebrae on a second side of the spinous process of the
patient wherein the second rod clamp assembly is introduced to the
longitudinal rod through a second minimally invasive incision on
the back of the patient at the level of the first vertebrae. A
first rod clamp extender is placed onto a pair of opposing wings of
the first rod clamp assembly. A clamp of the first rod clamp
assembly is secured to the first longitudinal rod with a screw on
the upper surface of the clamp of the first rod clamp assembly. A
second rod clamp extender is secured onto a pair of opposing wing
of the second rod clamp assembly. A clamp of the second rod clamp
assembly is secured to the second longitudinal rod with a screw on
the upper surface of the clamp of the second rod clamp assembly. An
extracorporeal portion of the first rod clamp extender is secured
to an extracorporeal portion of the second rod clamp extender via a
transverse rod passer pivotably mounted to the first rod clamp
extender and the second rod clamp extender about a pivot axis "A"
whose pivot axis passes through the head of the first rod clamp
assembly, the spinous process, and the head of the second rod clamp
assembly. A transverse rod opening is created in the spinous
process by piercing the spinous process with an awl that is
directed to the spinous process via the transverse rod passer as
the transverse rod passer is moved through pivot axis "A" path
percutaneously. The transverse rod connector is inserted into the
head of the second rod clamp assembly after passing through the
spinous process and through the head of the first rod clamp
assembly via the transverse rod connector guiding the transverse
rod through pivot axis "A" path. The transverse rod is secured to
the first rod clamp assembly.
[0012] Further still, the transverse rod is connected to a handle
with a flexible section that is removable from the transverse rod
for allowing the transverse rod to be positioned in a guide tube of
the transverse rod passer. An awl for creating an opening in the
spinous process includes a handle having a flexible shaft and a
sharp tip portion that is inserted through the guide tube of the
transverse rod passer. The first rod clamp assembly and the second
rod clamp assembly is disconnected from the transverse rod passer.
The screw on the upper surface of the clamp of the first rod clamp
assembly is tightened with a screw driver inserted percutaneously.
The pair of opposing wings of the first rod clamp assembly is
detached from the head portion leaving the head portion secured to
the transverse rod.
[0013] Further scope of applicability of the present invention will
be set forth in part in the detailed description to follow, taken
in conjunction with the accompanying drawings, and in part will
become apparent to those skilled in the art upon examination of the
following, or may be learned by practice of the invention. The
objects and advantages of the invention may be realized and
attained by means of the instrumentalities and combinations
particularly pointed out in the appended claims.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0014] The accompanying drawings in the attachment, which are
incorporated into and form a part of the specification, illustrate
one or more embodiments of the present invention and, together with
the description, serve to explain the principles of the invention.
The drawings are only for the purpose of illustrating one or more
preferred embodiments of the invention and are not to be construed
as limiting the invention. In the drawings:
[0015] FIG. 1A-C is an illustration of a rod clamp and rod clamp
assembly according to one embodiment of the present invention from
different view;
[0016] FIG. 2 is a stabilizing tower to slide over wings of a rod
clamp according to one embodiment of the present invention;
[0017] FIG. 3A-G illustrates a transverse rod passer system
according to one embodiment of the present invention;
[0018] FIG. 4 illustrates a transverse rod installment instrument
assembly according to one embodiment of the present invention;
[0019] FIG. 5 illustrates a transverse rod passer assembly in
association with a spinous process of a vertebra according to one
embodiment of the present invention;
[0020] FIG. 6 illustrates a transverse rod through the spinous
process of a vertebra in association with the transverse rod passer
assembly according to one embodiment of the present invention;
and
[0021] FIG. 7 illustrates a transverse rod associated with rod
clamps and bony structure of a vertebra according to one embodiment
of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0022] As used herein "a" or "an" means one or more.
[0023] One aspect of one embedment of a present invention provides
for a system and method for placement of a transverse connector on
the spine of an animal subject (e.g. human) wherein minimal if any
muscle dissection is required.
[0024] A set of innovative instruments and method of using the same
that allow precise placement of a transverse rod across the
vertebrae to a transverse rod connector through a percutaneous
route.
[0025] According to one embodiment of the present invention a
method for spinal fusion of adjacent vertebral bodies is provided
wherein an installation instrument for guiding a transverse rod to
connect with a rod clamp through a minimally invasive incision is
discussed. The method further provides that the transverse rod is
passed through the head of an ipsilateral rod clamp and inserted
through spinous process before connecting with the head of a
contralateral rod clamp.
[0026] An aspect of the present invention provides a transverse rod
installation instrument for transcutaneous placement of a
transverse rod wherein the installation instrument is mounted to
rod clamp extensions whose position is secured in an animal
subject.
[0027] One aspect of one embodiment of the present invention is a
minimally invasive method to stabilize bony structures.
[0028] One aspect provides for a method to connect two (2) or more
rod clamps with a connecting element.
[0029] A method to attach a transverse rod inserter on an
installation instrument to the extensions and guiding the
transverse rod into a desired position relative to the rod
clamps.
[0030] A fixed geometric relationship to guide the transverse rod
into a position proximate to the rod clamps.
[0031] According to one embodiment of the present invention an
installation instrument is mounted to the rod clamp extension
element in spatial relation to the anchors about a pivot point. The
instrument is rotated about the pivot point to guide the transverse
rod to the desired location.
[0032] According to another embodiment of the present invention an
installation instrument assembly is provided having an ispilateral
rod clamp extension designed to slide onto the wings of an
ipsilateral rod clamp and a contralateral rod clamp extension
designed to slide onto the wings of a contralateral rod clamp. The
rod clamp extensions each have an arm with a hole at the end of the
arm through which the two rod clamp extensions are secured
together. The installation instrument mounts to the ipsilateral and
contralateral rod clamp extension arms when the rod clamp
extensions are mounted to rod clamps positioned on either side of
the spinous process of a vertebra. In this position, the two arms
will overlap slightly when the rod clamp extensions are properly
positioned on the rod clamps to allow the holes at the end of each
arm to overlap. The installation assembly is held together with a
fastener that passes through all four holes of the arms including
the holes of the arms and the holes at the attachment ends of the
installation instrument which sandwich the two holes of the arms to
connect the installation instrument assembly together. The rod
clamps to which the rod clamp extension are mounted are positioned
on either side of spinous process and the rod clamps are secured to
a pedicle of a vertebra structure with pedicle screws. The
installation instrument is pivotable about a pivot axis that is
formed by a line that runs through the holes of the side arms and
holes of the attachment ends when assembled. The installation
instrument is moveable with respect to the rod clamps to position a
transverse brace through the spinous process of the vertebra and
secure the ends of the transverse rod to the head of the
ipsilateral and contralateral rod clamps.
[0033] Referring now to FIGS. 1A rod clamp assembly 100 having a
pair of opposing wings 104 that extend from clamp 101 includes a
tightening screw 105 which locks the clamp 101 to the longitudinal
rod 102 (not shown). There is a polyaxial head 109 which allows for
freedom of movement when positioning the rod passer. Referring now
to FIG. 1B, a tightening screw 105 sits in the superior portion of
the clamp 101 and acts to close down on the longitudinal rod on the
medial side of the rod but can secure the rod on the lateral side
of the rod as well. As shown by the arrows at the wings, the
poilyaxial head also allows for rotation. Bolts 111 are positioned
on the side of the wings and are used to secure the extenders (not
shown) when the extenders are positioned over the wings. Referring
now to FIG. 1C, the clamp 101 is secured to a longitudinal rod 102.
The longitudinal rod 102 is secured to a bony structure such as a
vertebra with a pedicle screw inserted into a pedicle of the
vertebra. The longitudinal rod 102 is positioned in the clamp 101.
Once pedicle screws and longitudinal rods are placed, a site is
identified on the rod clamp 100 where the transverse connector will
be connected, for example at head 107 of rod clamp assembly 100.
The head 107 has threads and below the threads a transverse rod
trough which is located superior to the clamp 101. FIG. 1C is a
side view of the rod clamp and wings. The wings 104 create a space
103 along the length "L" of the rod clamp as illustrated. A portion
of the wind of the rod clamp assembly is located extracorporeal. An
empty portion at the head 107 of rod clamp assembly is identified
where the transverse connector will be attached and secured with
set screws. The set screws are introduced through the distal
opening of the rod clamp assembly.
[0034] Facial openings are made is the skin and muscle and a
standard nasal speculum is used to visualize the rod clamp 100 and
longitudinal rod 102.
[0035] Referring now to FIG. 2, a stabilizing tower 201 is placed
on the wings 104 of the rod clamp assembly 100 and passes down the
rod clamp wings 104. Opening 202 in stabilizing tower 201 is used
to insert screw driver for tightening screw 105 of FIG. 1B. Once
the clamp is seated on the longitudinal rod for example, the rod
clamp sits as deep as possible against the longitudinal rod. The
tightening screw 105 on the rod clamp 101 is tightened to prevent
the rod clamp 101 from becoming disengaged from the longitudinal
rod 102. In the case of a spinal fusion there would be two rod
clamps with a first rod clamp secured on a left pedicle of vertebra
V and a second rod clamp secured on a right pedicle of vertebra V
as is shown in FIG. 5.
[0036] The stabilizing tower is removed from the rod clamp wings.
Referring now to FIG. 3A-3G, rod clamp extender/extension 303A
having arm 301A with a hole 302A is placed over the wings of a rod
clamp assembly 100. Rod clamp extender/extension cyclinder 303B
having arm 301B with a hole 302B is placed over the wings of a
second rod clamp attached to a different part of the bony
structure. Hole 302A is aligned with hole 302B having a bolt that
fits in hole 302A while hole 302A.sup.1 is aligned with hole
302B.sup.1 having a bolt that fits in hole 302A.sup.1 and also with
attachment end 315 of FIG. 3D and attachment end 313 of FIG. 3D of
installation instrument 307 of FIG. 3D such that rod clamp
extension 303A, rod clamp extension cyclinder 303B and installment
instrument 307 can be secured together by nut 305 at the end of rod
304 of FIG. 3C as is illustrated for the assembly in FIG. 4. An awl
329 of FIG. 3E having a handle 317, a flexible shaft (for example a
spring) 319 and a tip portion 321 is inserted through the guide
tube 309 of instrument 307 as illustrated in FIG. 3D. The flexible
shaft permits the shaft 319 of the awl to flex during insertion in
guide tube 309. FIG. 3B identifies the interior of the extender of
either 303A or 303B. There is a docking ring 306 for locking the
extender onto the bolt 111 of wing 104 when the assembly is in use
and the rod is passed through the spinous process. An internal
grove 310 secures the bolt 111 to stabilize the extender onto the
wing of the rod clamp. FIG. 3F illustrate a transverse rod
connected to a handle with a flexible section. The handle and
flexible section are removeable from the transverse rod. The
portion of 324 that is flexible for allowing the transverse rod to
be positioned in guide tube 309. FIG. 3G illustrates a cross
sectional view 316 of the extenders in position over the rod clamp
wings. The groove 317 at the bottom of the extenders slide over the
bolts 111. Once the extenders are securely seated, the docking ring
306 locks the extender onto the rod clamp wings.
[0037] Referring now to FIG. 4, the installation instrument
assembly 307 attached to the arms of rod clamp extender is
illustrated. The pivot Axis "P" about which the installation
instrument pivots is illustrated. The arms 301A and 301B join and
may be connected to attachment end 315 and attachment end 313 with
connector of FIG. 3C. Alternative installment instrument 307 can be
used with end 305 securing section 304 in place.
[0038] A skin and facial incision is made for when the awl 329
enters the skin on the Ipsilateral side of the body and the guide
tube 309 is advanced until the spinous process is encountered.
Referring now to FIG. 5, with firm pressure the awl 329 positioned
in guide tube 309 is advanced through the spinous process along arc
A on radius R. Visual confirmation through the contralateral rod
clamp will confirm that the awl has passed through the spinous
process. The guide tube 309 sits in the transverse rod trough of
107 which is superior to 101 but leaves adequate space at the
bottom for the awl 329 to pass through.
[0039] Referring now to FIG. 6, the guide tube 309 follows the same
trajectory as the awl is then swung out, the awl is removed and a
permanent transverse rod 324 of the appropriate length (confirmed
on fluoroscopy) is inserted in the guide tube 309 of the traverse
rod passer. The guide tube 309 of the transverse rod passer is
again advanced through arc A over radius R until the transverse rod
323 is appropriately seated in the head portion 107 of the rod
clamps 101. The installation instrument is removed. The rod clamp
extension is removed and wings 104 are broken off above section 107
leaving behind the transverse rod anchor 703 located superior to
the clamp 101 with the transverse rod and the longitudinal rod in
position secured to the bony structures of the pedicle and the
spinous process.
[0040] Referring now to FIG. 7, transverse rod anchor 703 secured
to the transverse rod 323 via set screws (not shown) with clamp 101
secured to longitudinal rod 102 with longitudinal rod 102 secured
to the vertebrae by pedicle screws (not shown) is illustrated.
[0041] Although the invention has been described in detail with
particular reference to these preferred embodiments, other
embodiments can achieve the same results. Variations and
modifications of the present invention will be obvious to those
skilled in the art and it is intended to cover in the appended
claims all such modifications and equivalents. The entire
disclosures of all references, applications, patents, and
publications cited above are hereby incorporated by reference
* * * * *