U.S. patent application number 10/992720 was filed with the patent office on 2006-05-25 for minimally invasive facet joint fusion.
This patent application is currently assigned to Orthopedic Development Corporation, A Florida Corporation. Invention is credited to David Ari Petersen.
Application Number | 20060111779 10/992720 |
Document ID | / |
Family ID | 36461924 |
Filed Date | 2006-05-25 |
United States Patent
Application |
20060111779 |
Kind Code |
A1 |
Petersen; David Ari |
May 25, 2006 |
Minimally invasive facet joint fusion
Abstract
A minimally invasive facet joint fusion including a method,
instrumentation and autograft, cadaveric allograft or FDA approved
pre-made, pre-shaped synthetic cortical bone grafts consistent with
the description and Claims herein for use in minimally invasive,
outpatient, arthroscopic spine surgery or classic open surgery and,
more specifically, to fuse spinal facet joints from T12-L1 through
L5-S1. This method serves as a primary or a revision surgery.
Inventors: |
Petersen; David Ari; (Indian
Rocks Beach, FL) |
Correspondence
Address: |
LARSON AND LARSON
11199 69TH STREET NORTH
LARGO
FL
33773
US
|
Assignee: |
Orthopedic Development Corporation,
A Florida Corporation
Clearwater
FL
|
Family ID: |
36461924 |
Appl. No.: |
10/992720 |
Filed: |
November 22, 2004 |
Current U.S.
Class: |
623/17.11 |
Current CPC
Class: |
A61B 2090/034 20160201;
A61F 2/28 20130101; A61B 17/7064 20130101; A61F 2002/30881
20130101; A61F 2/4405 20130101; A61B 17/1604 20130101; A61F 2/4455
20130101; A61F 2002/30785 20130101; A61L 27/3608 20130101; A61F
2310/00359 20130101; A61L 2430/02 20130101; A61B 17/1671
20130101 |
Class at
Publication: |
623/017.11 |
International
Class: |
A61F 2/44 20060101
A61F002/44 |
Claims
1. A bone dowel or plug made of a pre-made, pre-shaped human
cortical cadaveric allograft harvested from a femur or other
suitable donation site machined, pressed or otherwise conically
shaped in any size from 6 millimeters in width at the top to two
millimeters in width at the bottom and 0.5 to 2.0 centimeters in
length. The dowel or plug is conically shaped to be inserted into a
punched or drilled hole through any or all of the forty-eight facet
joints located vertebral segments C1-C2 through L5-S1. The dowel or
plug is then pressed into place using an accessory to the bone
punch/press described in claims 4 and 5.
2. The Device of claim 1 wherein said component is made of a
pre-made, pre-shaped synthetic bone or bone substitute.
3. The device of claim 1 wherein said component is made of cortical
bone autograft harvested from a patient's iliac crest, femur or
other suitable donation site.
4. The device of claim 1 wherein said component is made of a
pre-made, pre-shaped bovine cortical cadaveric allograft harvested
from a femur or other suitable donation site.
5. The device of claims 1-4 wherein said component is structurally
reinforced by adding a core of medical-grade high-density
polyethylene.
6. The device of claims 1-4 wherein said component is structurally
reinforced by adding a core of stainless steel.
7. The device of claims 1-4 wherein said component is structurally
reinforced by adding a core of cobalt-chrome alloy.
8. The device of claims 1-4 wherein said component is structurally
reinforced by adding a core of biocompatible metal.
9. The device of claims 1-4 wherein said component is structurally
reinforced by inserting a screw comprised of biocompatible metal in
the center of the device to provide additional compression and
structural stability.
10. The device of claims 1-4 wherein said component is structurally
reinforced by inserting a screw comprised of biocompatible
medical-grade high-density polyethylene in the center of the device
to provide additional compression and structural stability.
11. The device of claims 5-9 wherein said component includes an
outside surface coated with a porous coating.
12. The device of claim 11 wherein the said porous coating is the
same material of said component.
13. A bone punch suitable for use through an arthroscopic type
portal or in open surgery the same as or similar to the punch shown
in FIG. 1. The punch includes attachments to create different sized
holes to accommodate different sized devices of claims 1-4 to be
used at the discretion of the physician.
14. The device of claim 13 wherein said device includes a press
attachment suitable to compress said device of claims 1-4.
15. An osteotome as shown in FIG. 2 to strip away cartilage and
bone on both inner edges of a facet joint to prepare the bone for
in growth resulting in a permanent natural fusion.
16. Placement of said device of claims 1-9 in a vertebral facet
joint segment in any of the facet joints from C1-C2 through L5-S1
the same as or similar to the placement described in FIG. 3 as a
structural support until bone in growth occurs to create a
permanent natural fusion.
17. Reinforcement of said device of claims 1-9 in a vertebral facet
joint segment in any of the facet joints from C1-C2 through L5-S1
using a pin, suture, wire, tie, zip type tie, screw or any other
type of reinforcing fixation of any biocompatible construct or
material, absorbable or non-absorbable.
18. In a human spinal facet joint wherein a human, whether
allograft or autograft, bovine or synthetic bone or bone
substitute, whether or not it is reinforced with a center insert of
any absorbable or biocompatible material, porous or non-porous,
threaded or non-threaded, is inserted or pressed into a pre-made
hole reaching through or partially through the anterior to the
posterior joint segments so as to create a permanent or temporary
fusion of said joint.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] Not Applicable
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] Not Applicable
REFERENCE TO SEQUENCE LISTING, A TABLE, OR A COMPUTER PROGRAM
LISTING COMPACT DISK APPENDIX
[0003] Not Applicable
BACKGROUND OF THE INVENTION
[0004] The present invention relates generally to minimally
invasive spine surgery and, more particularly, to using an
arthroscopic type portal or open facet joint fusion surgical
method, instrumentation and either pre-made, pre-shaped synthetic
cortical bone or harvested and compacted iliac crest grafts,
autologous or cadaveric allografts. The instrumentation, graft and
fusion method is limited to the forty-eight facet joints located on
the spine, C1-C2 through L5-S1.
[0005] The use of pre-shaped, harvested or synthetic bone as a
structural fixation for facet joint fusion offers three distinct
advantages over pedicle or compression screws, which are presently
used in facet fusion procedures: (1) using bone instead of metal
allows for natural bone ingrowth and a stronger, permanent fusion;
(2) the natural or synthetic graft cannot work its way loose over
time, a concern with screw type fixation; and, (3) the graft is
self-leveling, which eliminates any concern of vertebral
tilting.
[0006] The instrumentation, grafts and method are specifically
designed for use in an arthroscopic type portal for stand-alone
procedures and provides a stronger, unique and superior fusion when
used as an adjunct to instrumented vertebral fusion by eliminating
the risk of collateral post-operative facet joint pain resulting
from additional stress placed on facet joints by the
instrumentation itself.
BRIEF SUMMARY OF THE INVENTION
[0007] A minimally invasive facet joint fusion for the treatment of
a diseased or painful facet joint that is not appropriate for
resurfacing or replacement comprises a method, instrumentation and
autograft, cadaveric allograft or FDA approved pre-made, pre-shaped
synthetic cortical bone graft for use in minimally invasive,
outpatient, arthroscopic spine surgery or classic open surgery and,
more specifically, to fuse spinal facet joints from C1-C2 through
L5-S1. This method serves as a primary or a revision surgery.
[0008] The present invention accomplishes a superior spinal facet
joint fusion by providing a method, instrumentation and grafting
alternatives to facilitate fusion using Arthroscopic portal or open
surgical techniques of the C1-C2 through L5-S1 spinal facet
joints.
[0009] According to one broad aspect of the present invention, the
Arthroscopic Facet Joint Fusion method comprises a punch or drill
that creates a hole through both levels of the facet joint in a
conical pattern. The hole is filled with either the patient's own
harvested and compacted bone plug using iliac crest autograft,
pre-made, pre-shaped shaped cortical cadaveric allograft (the
autograft or allograft formed by a unique bone plug press or
machining) or FDA approved pre-made, pre-shaped synthetic
grafts.
[0010] The punch or drill may include any number of components
capable of performing the creation of a hole through both sides of
the spinal facet joint using an arthroscope or similar portal to
access the joint or during classic open surgery. By way of example
only, the punch may include a hand actuator that will create
sufficient pressure to create a specific sized hole through both
sides of the spinal facet joint using a mechanical arrangement
similar to that of common pliers resized to work through an
arthroscopic opening. Additionally, a drill guide may be placed and
a specifically sized and shaped drill head may be used to create
the opening.
[0011] The bone plug press (graft forming or compression
instrument) may include any number of components capable of using
harvested autograft, cadaveric allograft cortical bone or a
synthetic alternative to match the bone tunnel made by the punch or
drill. By way of example only, the bone plug press may include a
mechanism similar to common pliers or a more standard hand press
that will transfer sufficient force to form bone plugs by squeezing
the handles together to form the bone plug and compress the bone or
synthetic alternative to the proper density and shape.
[0012] The impactor or press may include any number of components
capable of pushing and compressing the bone plug into the bone
tunnels. A suture or metallic overlay may also be applied to
provide additional structural stability to the joint during graft
incorporation.
BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWING
[0013] Many advantages of the present invention will be apparent to
those skilled in the art with a reading of this specification in
conjunction with the attached drawings, wherein like reference
numerals are applied to like elements and wherein:
[0014] FIG. 1 represents the punch and press mechanism described
herein according to the present invention.
[0015] FIG. 3 represents a properly completed procedure and the
resultant facet joint fusion.
DETAILED DESCRIPTION OF THE INVENTION
[0016] In the United States alone, about 10% of the entire
population will suffer from back pain sometime in the next 12
months. More people will contract back pain in the next year than
any other injury or disease except the common cold and flu. About
one third will not recover and have to live with persistent,
disabling symptoms. The number is cumulative year after year.
[0017] One of the root causes of back pain, particularly the
persistent and disabling kind, are facet joints, small joints
located behind adjacent vertebrae in the spine that allow for
spinal motion.
[0018] Present surgical solutions available for the millions of
people with facet joint dysfunctions are complex, invasive, pedicle
screw based high-risk operations with prolonged recovery times,
from 6 to 24 months, and uncertain outcomes. High risk equates to
frequent litigation, which forces non-surgical symptomatic
treatment while the disease or consequences of injury progressively
worsen. Some of these efforts provide intervertebral fusion
described in U.S. Pat. No. 6,485,518 and U.S. Patent application
Serial Number 2003/0032960. Numerous patents have been granted for
general fusion of the spine that may or may not involve the facet
joint by proximity or design.
[0019] With the advent of new, safer and less invasive surgical
techniques and technology, the growth of spine surgery now outpaces
every other orthopedic surgery segment. Its growth is further
fueled by an enormous demand.
[0020] If the joint is determined to be too badly damaged or
diseased for present replacement methods or prospective methods
such as Facet Joint Hemi-Arthroplasty, Minimally Invasive Facet
Joint Fusion is prospectively a superior alternative for three
primary reasons: [0021] 1. It is minimally invasive surgery that
can be performed in an outpatient setting as opposed to major
surgery performed in a hospital. This procedure can also be
performed during open surgery if the facet joints need to be fused
as determined by a physician particularly in conjunction with
instrumented vertebral fusion; [0022] 2. Recovery times are
estimated to be a few weeks as opposed to 6 to 12 months; and,
[0023] 3. It takes full advantage of advances in biomaterials and
synthetic alternatives.
[0024] The present invention is directed at overcoming, or at least
improving upon, the disadvantages of the prior art by achieving the
following: [0025] Reversal of the cost/benefit ratio of present
procedures versus the invention; [0026] A minimally invasive
procedure versus major open surgery; [0027] Outpatient versus
inpatient surgery (about 20 minutes per joint versus hours). Note:
this procedure may also be performed during open surgery at the
discretion of the physician; [0028] Can be used to augment present
open fusion techniques to lessen the need for bone stimulation
especially in high risk groups such as smokers and multi-level
cases; [0029] Reduced morbidity; [0030] Reduced blood loss; [0031]
Reduced time under anesthesia; [0032] Reduced risk; [0033] Recovery
time dramatically reduced; [0034] Minimal scarring that decreases
the risk of failed back syndrome and improves revision surgery
outcome; [0035] Reduced risk of post operative infection by
significantly reducing operating room time and soft tissue
destruction; [0036] No preclusion of other surgical or non-invasive
treatment options; and, [0037] Projected high success rate by
utilizing accepted arthroscopic procedures employing a new
technique and taking advantage of either existing cortical bone
harvesting procedures in combination with unique instrumentation to
shape and prepare the bone or new pre-shaped, pre-made synthetic
cortical bone alternatives as they are made generally available by
FDA approval.
[0038] It is anticipated that the availability of this method,
instrumentation and graft alternatives will dramatically increase
the number of surgeries performed because they offer the first safe
outpatient surgical solution to the predominant cause of spinal
joint pain. The inventor also expects that virtually all patients
receiving this procedure will be able to walk out the same day and
be fully functional within a few weeks. Present surgical solutions
require hospitalization of about three days and six to twenty-four
months' recovery.
[0039] Aside from the obvious positive clinical outcome, the
significant favorable financial impact on disability, worker's
compensation and health care insurers is considerable.
[0040] Spinal facet implant units are calculated per joint. Each
patient has two joints per spinal segment and twenty-four segments,
C1-C2 through L5-S1 for a total of forty-eight facet joints. Each
surgery is likely to involve multiple joints.
[0041] The present invention is directed at overcoming, or at least
improving upon, the disadvantages of the prior art.
[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 Arthroscopic Facet Joint Fusion method,
instrumentation and pre-made, pre-shaped natural or synthetic bone
implants disclosed herein boast a variety of inventive features and
components that warrant patent protection, both individually and in
combination.
[0043] FIG. 1 illustrates a bone punch instrument as an embodiment
of the invention shown without representation of a press accessory,
which can be attached to the punch tips (4) and used to press a
bone plug more completely described in FIG. 3 (6) into place. The
instrument is specifically invented to be used through an
arthroscopic type portal (1) allowing access to the joint through a
small incision and progressive dilation of the intervening soft
tissue. The instrument design does not preclude its use in a
classic open surgery or by access to the facet joint through an
otherwise limited incision. A separating handle (2) is specifically
designed to provide sufficient mechanical advantage to the punch
tips (4). Punch tips of different sizes to create an appropriate
opening to receive the sized bone plug selected by a physician. The
opening is marginally smaller than the bone plug to create proper
fixation of the plug and the joint. Mechanical advantage created by
pressure on the handle is transferred to the punch tips using an
"X" type joint (3).
[0044] FIG. 2 illustrates a specially designed osteotome as an
embodiment of the invention, which accesses the facet joint through
an arthroscopic type portal (5) and is used to make a thin slice
into the bone on each of the inner surfaces of the joint to prepare
the surface to heal together in a permanent fusion. The osteotome
is equipped with a specifically sized single use blade (6) shown in
situ in the correct aspect into a facet joint (7). The osteotome is
impacted with a slap-hammer (8) to make the cuts and is properly
positioned using a loop (9) on the osteotome shaft. A protective
stop (10) is provided to ensure that the osteotome blade does not
penetrate to an unsafe depth.
[0045] FIG. 3 illustrates a fused facet joint (11) with one shaped
autograft, cadaveric allograft or FDA approved synthetic pre-made,
pre-shaped cortical bone plug (12). The posterior end of the plug
is 2 mm to 3 mm (13) and the anterior end of the plug is 3 mm to 4
mm (14) in a conical shape with the wider portion located in the
anterior portion to facilitate fixation during bone graft
incorporation. The procedure is envisioned to require only one bone
plug. Permanent fixation occurs when bone in-growth occurs into the
joint itself and into the plug (15) over time.
* * * * *