U.S. patent application number 10/269601 was filed with the patent office on 2004-04-15 for electro-stimulation and medical delivery device.
This patent application is currently assigned to Spineco, Inc., a corporation of Ohio. Invention is credited to Biscup, Robert S..
Application Number | 20040073221 10/269601 |
Document ID | / |
Family ID | 32068823 |
Filed Date | 2004-04-15 |
United States Patent
Application |
20040073221 |
Kind Code |
A1 |
Biscup, Robert S. |
April 15, 2004 |
Electro-stimulation and medical delivery device
Abstract
A pedicle screw for at least partial insertion into a bone
and/or cartilage. The pedicle screw includes a head and a lower
portion connected to the head. The lower portion includes at least
one interface that designed to at least partially discharge an
electrical current, and/or a medical substance to or adjacent to
the bone and/or cartilage.
Inventors: |
Biscup, Robert S.; (Chagrin
Falls, OH) |
Correspondence
Address: |
Fay, Sharpe, Fagan, Minnich & McKee, LLP
7th Floor
1100 Superior Avenue
Cleveland
OH
44114-2518
US
|
Assignee: |
Spineco, Inc., a corporation of
Ohio
|
Family ID: |
32068823 |
Appl. No.: |
10/269601 |
Filed: |
October 11, 2002 |
Current U.S.
Class: |
604/891.1 ;
606/301; 606/41 |
Current CPC
Class: |
A61B 17/7001 20130101;
A61B 17/86 20130101; A61N 1/205 20130101; A61B 17/3472
20130101 |
Class at
Publication: |
606/073 |
International
Class: |
A61B 017/56 |
Claims
I claim:
1. A bone screw for at least partial insertion into a bone and/or
cartilage comprising a head and a lower portion connected to the
head, said lower portion including at least one interface that is
designed to at least partially discharge an electrical current, a
medical substance, and combinations thereof to or adjacent to the
bone and/or cartilage.
2. The bone screw as defined in claim 1, wherein said lower portion
includes at least one cavity that contains at least one electrical
mechanism, at least one mechanical mechanism, at least one medical
substance, and combinations thereof.
3. The bone screw as defined in claim 2, wherein said at least one
cavity includes at least one access opening on an outer surface of
said lower portion.
4. The bone screw as defined in claim 1, wherein said head includes
at least one cavity that contains at least one electrical
mechanism, at least one mechanical mechanism, at least one medical
substance, and combinations thereof.
5. The bone screw as defined in claim 2, wherein said head includes
at least one cavity that contains at least one electrical
mechanism, at least one mechanical mechanism, at least one medical
substance, and combinations thereof.
6. The bone screw as defined in claim 3, wherein said head includes
at least one cavity that contains at least one electrical
mechanism, at least one mechanical mechanism, at least one medical
substance, and combinations thereof.
7. The bone screw as defined in claim 4, wherein said at least one
cavity includes at least one access opening on an outer surface of
said head.
8. The bone screw as defined in claim 6, wherein said at least one
cavity includes at least one access opening on an outer surface of
said head.
9. The bone screw as defined in claim 5, wherein said at least one
cavity includes at least one access opening on an outer surface of
said lower portion, said head, and combinations thereof.
10. The bone screw as defined in claim 1, wherein said medical
substance includes at least one antithrombogenic agent, steroid,
thioprotese inhibitor, antimicrobial, antibiotic, tissue plasma
activator, monoclonal antibody, anti fibrosis compound, hormone,
growth factor, anti-mitotic agent, immunosuppressive agent, sense
or antisense oligonucleotide, nucleic acid analogue, inhibitor of
transcription factor activity, anti-neoplastic compound,
chemotherapeutic compound, radioactive agent, growth factor,
antiplatlet compound, antitabolite compound, anti-inflammatory
compound, anticoagulent compound, antimitotic compound,
antioxidant, antimetabolite compound, anti-migratory agent,
anti-matrix compound, anti-vital compound, anti-proliferative,
anti-fungal compound, anti-protozoal compound, human tissue; animal
tissue; synthetic tissue; human cells; animal cells; synthetic
cells; bone-stimulation matter; bone-growth matter; bone activating
matter; and combinations thereof.
11. The bone screw as defined in claim 8, wherein said medical
substance includes at least one antithrombogenic agent, steroid,
thioprotese inhibitor, antimicrobial, antibiotic, tissue plasma
activator, monoclonal antibody, anti fibrosis compound, hormone,
growth factor, anti-mitotic agent, immunosuppressive agent, sense
or antisense oligonucleotide, nucleic acid analogue, inhibitor of
transcription factor activity, anti-neoplastic compound,
chemotherapeutic compound, radioactive agent, growth factor,
antiplatlet compound, antitabolite compound, anti-inflammatory
compound, anticoagulent compound, antimitotic compound,
antioxidant, antimetabolite compound, anti-migratory agent,
anti-matrix compound, anti-vital compound, anti-proliferative,
anti-fungal compound, anti-protozoal compound, human tissue; animal
tissue; synthetic tissue; human cells; animal cells; synthetic
cells; bone-stimulation matter; bone-growth matter; bone activating
matter, and combinations thereof.
12. The bone screw as defined in claim 2, wherein said at least one
mechanical mechanism includes a pump.
13. The bone screw as defined in claim 4, wherein said at least one
mechanical mechanism includes a pump.
14. The bone screw as defined in claim 9, wherein said at least one
mechanical mechanism includes a pump.
15. The bone screw as defined in claim 11, wherein said at least
one mechanical mechanism includes a pump.
16. The bone screw as defined in claim 2, wherein said at least one
electrical mechanism includes a battery, a generator, and
combinations thereof.
17. The bone screw as defined in claim 9, wherein said at least one
electrical mechanism includes a battery, a generator, and
combinations thereof.
18. The bone screw as defined in claim 11, wherein said at least
one electrical mechanism includes a battery, a generator, and
combinations thereof.
19. The bone screw as defined in claim 15, wherein said at least
one electrical mechanism includes a battery, a generator, and
combinations thereof.
20. The bone screw as defined in claim 4, wherein said at least one
electrical mechanism includes a battery, a generator, and
combinations thereof.
21. The bone screw as defined in claim 2, wherein said at least one
electrical mechanism includes a microchip controller.
22. The bone screw as defined in claim 4, wherein said at least one
electrical mechanism includes a microchip controller.
23. The bone screw as defined in claim 2, wherein said at least one
mechanical mechanism includes a microchip controller.
24. The bone screw as defined in claim 15, wherein said at least
one mechanical mechanism includes a microchip controller.
25. The bone screw as defined in claim 19, wherein said at least
one mechanical mechanism includes a microchip controller.
26. The bone screw as defined in claim 4, wherein said at least one
mechanical mechanism includes a microchip controller.
27. The bone screw as defined in claim 18, wherein said at least
one mechanical mechanism includes a microchip controller.
28. The bone screw as defined in claim 25, wherein said at least
one mechanical mechanism includes a microchip controller.
29. The bone screw as defined in claim 3, including a cap or cover
that at least partially obstructs said access opening.
30. The bone screw as defined in claim 7, including a cap or cover
that at least partially obstructs said access opening.
31. The bone screw as defined in claim 28, including a cap or cover
that at least partially obstructs said access opening.
32. The bone screw as defined in claim 29, wherein said cap or
cover is removably inserted in or about said access opening.
33. The bone screw as defined in claim 30, wherein said cap or
cover is removably inserted in or about said access opening.
34. The bone screw as defined in claim 31, wherein said cap or
cover is removably inserted in or about said access opening.
35. The bone screw as defined in claim 29, wherein said cap or
cover is at least partially biodegradable.
36. The bone screw as defined in claim 30, wherein said cap or
cover is at least partially biodegradable.
37. The bone screw as defined in claim 31, wherein said cap or
cover is at least partially biodegradable.
38. The bone screw as defined in claim 1, wherein said head and/or
lower portion at least partially includes a coating material, said
coating material including a compound that facilitates in the
insertion and/or securing of the lower portion in said bone and/or
cartilage; promotes and/or inhibits bone and/or other tissue
growth; inhibits rejection of said bone screw; inhibits rejection
of components connected to and/or located adjacent to said bone
screw; reduces infection; reduces inflammation; reduces pain;
promotes healing of surrounding tissue; combats cancer and/or other
diseases; combats biological abnormalities; functions as a location
and/or visual indicator; and combinations thereof.
39. The bone screw as defined in claim 2, wherein said head and/or
lower portion at least partially includes a coating material, said
coating material including a compound that facilitates in the
insertion and/or securing of the lower portion in said bone and/or
cartilage; promotes and/or inhibits bone and/or other tissue
growth; inhibits rejection of said bone screw; inhibits rejection
of components connected to and/or located adjacent to said bone
screw; reduces infection; reduces inflammation; reduces pain;
promotes healing of surrounding tissue; combats cancer and/or other
diseases; combats biological abnormalities; functions as a location
and/or visual indicator; and combinations thereof.
40. The bone screw as defined in claim 4, wherein said head and/or
lower portion at least partially includes a coating material, said
coating material including a compound that facilitates in the
insertion and/or securing of the lower portion in said bone and/or
cartilage; promotes and/or inhibits bone and/or other tissue
growth; inhibits rejection of said bone screw; inhibits rejection
of components connected to and/or located adjacent to said bone
screw; reduces infection; reduces inflammation; reduces pain;
promotes healing of surrounding tissue; combats cancer and/or other
diseases; combats biological abnormalities; functions as a location
and/or visual indicator; and combinations thereof.
41. The bone screw as defined in claim 34, wherein said head and/or
lower portion at least partially includes a coating material, said
coating material including a compound that facilitates in the
insertion and/or securing of the lower portion in said bone and/or
cartilage; promotes and/or inhibits bone and/or other tissue
growth; inhibits rejection of said bone screw; inhibits rejection
of components connected to and/or located adjacent to said bone
screw; reduces infection; reduces inflammation; reduces pain;
promotes healing of surrounding tissue; combats cancer and/or other
diseases; combats biological abnormalities; functions as a location
and/or visual indicator; and combinations thereof.
42. The bone screw as defined in claim 37, wherein said head and/or
lower portion at least partially includes a coating material, said
coating material including a compound that facilitates in the
insertion and/or securing of the lower portion in said bone and/or
cartilage; promotes and/or inhibits bone and/or other tissue
growth; inhibits rejection of said bone screw; inhibits rejection
of components connected to and/or located adjacent to said bone
screw; reduces infection; reduces inflammation; reduces pain;
promotes healing of surrounding tissue; combats cancer and/or other
diseases; combats biological abnormalities; functions as a location
and/or visual indicator; and combinations thereof.
43. A connector that is a bone screw, nail or post for at least
partial insertion into a bone and/or cartilage comprising a head
and a lower portion connected to the head; said lower portion
including at least one cavity; said cavity adapted to include at
least one medical substance selected from the group consisting
essentially of antithrombogenic agent, steroid, thioprotese
inhibitor, antimicrobial, antibiotic, tissue plasma activator,
monoclonal antibody, antifibrosis compound, hormone, growth factor,
anti-mitotic agent, immunosuppressive agent, sense or antisense
oligonucleotide, nucleic acid analogue, inhibitor of transcription
factor activity, anti-neoplastic compound, chemotherapeutic
compound, radioactive agent, growth factor, antiplatlet compound,
antitabolite compound, anti-inflammatory compound, anticoagulent
compound, antimitotic compound, antioxidant, antimetabolite
compound, anti-migratory agent, anti-matrix compound, anti-vital
compound, anti-proliferative, anti-fungal compound, anti-protozoal
compound, human tissue; animal tissue; synthetic tissue; human
cells; animal cells; synthetic cells; bone-stimulation matter;
bone-growth matter; bone activating matter, and combinations
thereof; said cavity including at least one access opening adapted
to allow said at least one medical substance to flow from said at
least one cavity to an outer surface of said connector.
44. The connector as defined in claim 43, including a pump
mechanism that at partially causes said at least one medical
substance to flow from said at least one cavity, through said at
least one access opening and to an outer surface of said
connector.
45. The connector as defined in claim 44, wherein said a pump
mechanism is at least partially contained in said head, said lower
portion, and combinations thereof.
46. The connector as defined in claim 44, wherein said pump
mechanism is at least partially attached to said head, said lower
portion, and combinations thereof.
47. The connector as defined in claim 45, wherein said pump
mechanism is at least partially attached to said head, said lower
portion, and combinations thereof.
48. The connector as defined in claim 44, wherein said pump
mechanism includes at least one MEMS, said MEMS at least partially
controlling a rate of flow of said at least one medical substance
from said at least one cavity, through said at least one access
opening and to an outer surface of said connector.
49. The connector as defined in claim 44, wherein said pump
mechanism includes at least one microchip, said microchip at least
partially controlling a rate of flow of said at least one medical
substance from said at least one cavity, through said at least one
access opening and to an outer surface of said connector.
50. A connector that is a bone screw, nail or post for at least
partial insertion into a bone and/or cartilage comprising a head
and a lower portion connected to the head; said lower portion
including at least one cavity; said cavity adapted to at least
partially include at least one electrical mechanism, said
electrical mechanism adapted to discharge a current to said bone
and/or tissue positioned at least closely adjacent to said
connector.
51. The connector as defined in claim 50, including an electrical
source selected from the group consisting of a battery, electric
generator, and combinations thereof.
52. The connector as defined in claim 50, including at least one
electrical contact point at an outer surface of said head and/or
lower portion.
53. The connector as defined in claim 50, wherein said a electrical
mechanism is at least partially contained in said head, said lower
portion, and combinations thereof.
54. The connector as defined in claim 50, wherein said electrical
mechanism is at least partially attached to said head, said lower
portion, and combinations thereof.
55. The connector as defined in claim 53, wherein said electrical
mechanism is at least partially attached to said head, said lower
portion, and combinations thereof.
56. The connector as defined in claim 50, wherein said electrical
mechanism includes at least one MEMS, said MEMS at least partially
controlling a rate of discharge of current.
57. The connector as defined in claim 50, wherein said electrical
mechanism includes at least one microchip, said microchip at least
partially controlling a rate of discharge of current.
58. A method of at least partially inserting a connector into a
bone and/or cartilage comprising: a) selecting a connector that
includes a bone screw, nail or post having a head and a lower
portion connected to the head, said lower portion and/or head
including at least one interface that at least partially discharges
an electrical current, a medical substance, and combinations
thereof to and/or adjacent to the bone and/or cartilage, said
interface including at least one access opening, at at least one
electric contact point, and combinations thereof; b) at least
partially inserting said connector into said bone and/or cartilage;
and, c) discharging the electrical current, the medical substance,
and combinations thereof to promote healing of said bone and/or
cartilage about said connector.
Description
[0001] The present invention pertains to prosthetic implants, and
more particularly to pedicle screws, nails or posts that can be
inserted into bone and/or cartilage.
BACKGROUND OF THE INVENTION
[0002] The human spine is made up of a column of thirty-three bones
and their adjoining structures. The bodies of these vertebrae are
connected by anterior and posterior ligaments and by discs of
fibrocartilage generally known as intervertebral discs. These discs
are positioned between opposite faces of adjacent vertebral bodies.
This column of vertebrae and intervertebral discs form a central
axis that supports the head and torso. These vertebrae also enclose
an opening through which the spinal cord passes.
[0003] The presaccral vertebrae are normally held in position to
one another by the intervertebral discs, ligaments and musculature
of the body. These vertebrae move relative to adjacent vertebrae
thus permitting the head to be turned relative the body and
providing a wide range of flexibility to the spine.
[0004] One of the most costly health problems in society involves
back pain and pathology of the spine. These problems can affect
individuals of all ages and can result in great suffering to
victims. Back pain can be caused by several factors such as
congenital deformities, traumatic injuries, degenerative changes to
the spine, and the like. Such changes can cause painful excessive
motion, or collapse of a motion segment resulting in the
contraction of the spinal canal and compression of the neural
structures, causing debilitating pain, paralysis or both, which in
turn can result in nerve root compression or spinal stenosis.
[0005] Nerve conduction disorders can also be associated with
intervertebral discs or the vertebrae themselves. One such
condition is herniation of the intervertebral disc, in which a
small amount of tissue protrudes from the sides of the disc into
the foramen to compress the spinal cord. A second common condition
involves the development of small bone spurs, termed osteophytes,
along the posterior surface of the vertebral body, again impinging
on the spinal cord.
[0006] Upon identification of these abnormalities, surgery may be
required to correct the problem. For those problems associated with
the formation of osteophytes or herniations of the intervertebral
disc, one such surgical procedure is intervertebral discectomy. In
this procedure, the involved vertebrae are exposed and the
intervertebral disc is removed, thus removing the offending tissue
or providing access for the removal of the bone osteophytes. A
second procedure, termed a spinal fusion, may then be required to
fix the vertebrae together to prevent movement and maintain a space
originally occupied by the intervertebral disc. Although this
procedure may result in some minor loss and flexibility in the
spine, due to the relatively large number of vertebrae, the minor
loss of mobility is typically acceptable.
[0007] For the replacement of vertebra of the human spinal column,
for the distraction of the spinal column, for the stabilization of
the vertebrae and likewise, it is known to apply pedicle screws.
The pedicle screw is screwed into the pedicle of the vertebra and
the head of the pedicle screw is connected to suitable provisions,
for example to a stabilizing system, to distraction rods, etc.
During the treatment of the spine, the pedicle screw is generally
first rotated into the pedicle. Subsequently, the insertion of the
rod is effected.
[0008] A standard pedicle screw assembly comprises a screw having
an externally threaded stem having in turn a head provided with
parts allowing it to be secured to one end of a distraction rod.
Typically two such pedicle screws are inserted into respective
vertebrae and are secured to a rod to distract and/or stabilize a
spinal column after, for instance, a disk operation. One commonly
used pedicle screw is disclosed in German Patent No. 4,107,480,
which is incorporated herein by reference, and includes a head that
has a pair of outwardly projecting parallel ridges with overhanging
inner edges. A cap formed with a pair of complementary inwardly
open slots fit with these ridges. The pedicle screw is threaded
into the vertebrae, an end of the rod is fitted to its outer end,
the cap is then slid transverse to the pedicle screw axis and
parallel to the rod over the rod to capture it, and finally a cap
screw threaded into the cap and tightened to press the rod down
against the head of the pedicle screw and thereby fix the rod, cap,
and screw together. Many other pedicle screw designs have been
developed to simplify the insertion of the pedicle screw into the
pedicle, and/or to reduce damage to the pedicle screw and/or the
pedicle during surgery. Some of these pedicle screw designs are
disclosed in U.S. Pat. Nos. 5,882,350; 5,989,254; 5,997,539;
6,004,322; 6,004,349; 6,017,344; 6,053,917; 6,056,753; 6,083,227;
6,113,601; 6,183,472; 6,224,596; 6,368,319; 6,375,657; and
6,402,752; and the patents cited and disclosed in such patents. All
these designs of pedicle screws are incorporated herein by
reference.
[0009] After the pedicle screw is inserted in the pedicle, the bone
around the pedicle screw must heal to properly secure the pedicle
screw in the bone. Any infection that occurs around the pedicle
screw can slow the healing process and/or damage the bone around
the pedicle screw thereby weakening the connection between the bone
and pedicle screw. Typically, a patient is given antibiotics for
several days after the surgery to reduce the occurrence of
infection about the pedicle screw. The patient may also receive
electrical stimulation during surgery to promote the healing
process of the bone about the pedicle screw. Both of these
techniques have improved the post-operative success of the surgical
procedure; however, improved success rates are still needed.
[0010] In view of the present state of technology related to
prosthetic implants, there is a continued need for pedicle screws
that reduce the occurrence of post-operative failure due to
infection and/or improper healing about the pedicle screw.
SUMMARY OF THE INVENTION
[0011] The present invention pertains to an improved implant, and
more particularly to an improved connector such as, but not limited
to, a screw, nail or post which promotes healing about the screw,
nail or post, and even more particularly to an improved pedicle
screw, nail or post which promotes healing about the screw, nail or
post.
[0012] In accordance with the principal feature of the present
invention, there is provided an improved screw, nail or post used
for insertion into bone and/or cartilage. The screw, nail or post
is generally used to anchor and/or affix an implant (e.g., rod,
cage, stabilization system, etc.) to the bone and/or cartilage;
however, the screw, nail or post can be used for other uses such
as, but not limited to, attachment of ligaments; connecting and/or
repairing broken bones; reducing pain; stabilizing a tissue
ligaments, cartilage, and/or bone; an adjunct for another surgical
procedure and the like. In one embodiment of the present invention,
the screw, nail or post is used to repair a spinal column. During
the replacement of vertebra of the human and/or animal spinal
column, the distraction of the spinal column, and/or the
stabilization of the spinal column, pedicle screws, nails, and/or
posts of the present invention can be used. Generally, the screw,
nail, and/or post is inserted into the pedicle of the vertebra;
however, the screw, nail or post can be connected to other regions
of the vertebra. In still another and/or alternative embodiment of
the invention, the screw, nail or post is used in areas of a body
other than the spine. In one aspect of the embodiment, the screw,
nail or post is used to connect together fractured or broken bones.
The bone or bones are not limited to bones of the vertebra, but
include any bone in which the screw, nail or post can be used to at
least partially heal the bone. In another and/or alternative aspect
of the embodiment, the screw, nail or post is used to connect
ligaments together and/or to bone and/or cartilage. In still
another and/or alternative aspect of the embodiment, the screw,
nail or post is used to retain tissue (e.g., organs, muscle, etc.)
in place. In yet another and/or alternative embodiment of the
present invention, the screw, nail or post includes a head and a
lower portion. In one aspect of this embodiment, the top surface of
the head can have a number of different shapes (e.g, flat, sloped,
acuate, circular, polygonal, etc.). In another and/or alternative
aspect of this embodiment, the head can have a number of different
surfaces (e.g., smooth, rough, ribbed, etc.). In still another
and/or alternative aspect of this embodiment, the head can have a
number of different shapes (e.g., spherical, ellipsoidal, cubic,
orthogonic, etc.). In yet another and/or alternative aspect of this
embodiment, the head can have a various side surfaces (e.g. ribs,
grooves, slots, pits, etc.). In still yet another and/or
alternative aspect of this embodiment, the head can include one or
more openings. In still another and/or alternative aspect of this
embodiment, the head can include one or more connectors. In a
further and/or alternative aspect of this embodiment, the head can
be rigidly connected to the lower portion or moveably connected to
the lower portion. The shapes, surfaces, connectors, and/or
openings of the head, and/or the type of connection between the
head and lower portion a) facilitate in the insertion and/or
removal of the screw, nail or post into bone and/or cartilage, b)
facilitate in the attachment and/or disconnection of the head from
other components of an implant (e.g., a stabilizing system,
distraction rods, cage, mechanical and/or electrical mechanisms,
insertion and/or removal tools, etc.), and/or c) facilitate in the
operation of the implant and/or components connected to the screw,
nail or post. In another and/or alternative embodiment of the
invention, the lower portion of the screw includes a threaded outer
surface. The nail or post may or may not have a threaded surface.
In still another and/or alternative embodiment of the invention,
the lower portion of the screw, nail or post can have a smooth
surface, ribs, channels, barbs, teeth, etc. In yet another and/or
alternative embodiment of the invention, the end of the lower
portion of the screw, nail or post can be flat, sharp, forked, etc.
In still yet another and/or alternative embodiment of the
invention, the cross-sectional shape and/or area along the length
of the lower portion can be constant or can vary. In one aspect of
this embodiment, the cross-sectional shape and/or area along the
length of the lower portion remains substantially constant. In
another and/or alternative aspect of this embodiment, the
cross-sectional shape and/or area along the length of the lower
portion tapers along at least a portion of the lower portion. In a
further and/or alternative embodiment of the invention, the lower
portion can have a number of cross-sectional shapes (e.g. circular,
polygonal, oval, arcuate, etc.). In still another and/or and/or
alternative embodiment of the present invention, the head of the
screw, nail or post can be designed to break off after inserting
the lower portion into the bone and/or cartilage, and/or an
implant. In still yet another and/or alternative embodiment of the
present invention, lower portion of the screw, nail or post can
include a feature (e.g., bore, notch, etc.) which facilitates
subsequent removal of the lower portion from the location in which
it is secured, and/or facilitate in the connection or more or more
devices to the lower portion. In a further and/or alternative
embodiment of the present invention, the lower portion can lie in a
single axis or multiple axes. In one aspect of this embodiment, the
one or more axes of the lower portion is fixed. In another and/or
alternative aspect of this embodiment, the one or more axes of the
lower portion can be altered. In essence, the screw, nail, or post
has a configuration that suits the particular application of the
screw, nail or post. In still further and/or alternative embodiment
of the present invention, the screw, nail or post is designed to
firmly secure one or more components of an implant to bone and/or
cartilage to thereby reduce or prevent rotational or translational
movement of one or more components of the implant. In yet a further
and/or alternative embodiment of the present invention, the screw,
nail or post is designed to be relatively small yet constructed to
withstand sufficiently high torque and/or compressive forces to
firmly set the screw, nail or post in the bone and/or cartilage. In
still yet a further and/or alternative embodiment of the present
invention, the screw, nail or post is designed to be easily
manipulated to permit relatively rapid insertion and/or tightening
during surgical procedures.
[0013] In another and/or alternative aspect of the invention, the
screw, nail or post includes one or more cavities. The one or more
cavities can be used for a variety of reasons such as, but not
limited to, 1) weight distribution of the screw, nail or post; 2)
structural integrity of the screw, nail or post (e.g., break
points, flex points, compression points, etc.); 3) at least
partially containing a substance such as, but not limited to, a
material that a) promotes and/or inhibits bone and/or other tissue
growth, b) inhibits rejection of the screw, nail or post, c)
inhibits rejection of components connected to and/or located
adjacent to the screw, nail or post, d) reduces infection, e)
reduces inflammation, f) reduces pain, g) provides vitamins and/or
minerals, h) provides genetic material, i) provides tissue, j)
promotes healing of surrounding tissue, k) combats or cures cancer
and/or other diseases, l) functions as a location and/or visual
indicator, and/or the like; and/or 4) at least partially contains
one or more electrical and/or mechanical components. In one
embodiment of the present invention, the screw, nail or post
includes a single cavity. In another and/or alterative embodiment
of the present invention, the screw, nail or post includes a
plurality of cavities. In one aspect of this embodiment, at least
one cavity is separated from one other cavity. In another and/or
alternative aspect of this embodiment, two or more cavities are
connected together by one or more passageways. In still another
and/or alternative embodiment of the present invention, at least
one cavity has at least one access opening to the surface of the
screw, nail or post. The access opening is generally designed to
allow fluids and/or other material to flow into and/or out of the
cavity. The size of the access is generally sized to regulate or
control the fluid and/or material flow through the access opening.
In yet another and/or alternative embodiment of the invention, the
size of the one or more cavities is less than about 70% of the
total volume of the screw, nail or post. In one aspect of this
embodiment, the size of the one or more cavities is generally less
than about 50% of the total volume of the screw, nail or post,
typically less than about 40% of the total volume of the screw,
nail or post, more typically less than about 30% of the total
volume of the screw, nail or post, still more typically less than
about 20% of the total volume of the screw, nail or post, and even
more typically less than about 10% of the total volume of the
screw, nail or post. In still yet another and/or alternative
embodiment of the present invention, the shape of the one or more
cavities is selected for a particular application of the one or
more cavities. Any number of cavity shapes can be used (e.g.,
spherical, cylindrical, ovoid, pyramidal, cubical, orthogonic,
etc.). Two or more cavities can have the same or different shape
and/or volume. In a further and/or alternative embodiment of the
present invention, the one or more cavities are located in the head
of the screw, nail or post. In one aspect of this embodiment, at
least a majority of the cavities and/or the majority of the volume
of the cavities are located in the head. In still a further and/or
alternative embodiment of the present invention, the one or more
cavities are located in the lower portion of the screw, nail or
post. In one aspect of this embodiment, at least a majority of the
cavities and/or a majority of the volume of the cavities are
located in the lower portion. In another and/or alternative aspect
of this embodiment, the same number of cavities and/or the same
volume of the cavities is located in the head and lower
portion.
[0014] In still another and/or alternative aspect of the present
invention, one or more substances are included on and/or in the
screw, nail or post to improve the success of inserting the screw,
nail, or post into the bone and/or cartilage, and/or to promote
healing about the screw, nail or post. In one embodiment of the
present invention, the substance includes, but is not limited to,
antithrombogenic agents; steroids; thioprotese inhibitors;
antimicrobials; antibiotics; tissue plasma activators; monoclonal
antibodies; antifibrosis compounds; hormones; growth factors;
anti-mitotic agents; immunosuppressive agents; sense or antisense
oligonucleotides; nucleic acid analogues; inhibitors of
transcription factor activity; anti-neoplastic compounds;
chemotherapeutic compounds; radioactive agents; growth factors;
antiplatlet compounds; antitabolite compounds; anti-inflammatory
compounds; anticoagulent compounds; antimitotic compounds;
antioxidants; antimetabolite compounds; anti-migratory agents;
anti-matrix compounds; anti-vital compounds; anti-proliferatives;
anti-fungal compounds; anti-protozoal compounds; human tissue;
animal tissue; synthetic tissue; human cells, animal cells;
synthetic cells; and/or bone-stimulation, bone-growth and/or
bone-activating matter. In another and/or alternative embodiment of
the present invention, one or more substances are included in one
or more cavities of the screw, nail or post. In one aspect of this
embodiment, one or more cavities includes a single type of
substance. In still another and/or alternative embodiment of the
present invention, the cavity includes a multiple types of
substances. In yet another and/or alternative embodiment of the
present invention, one or more cavities can be partially or fully
filled with one or more substances. In still yet another and/or
alternative embodiment of the present invention, the one or more
substances are partially or fully coated on the surface of the
screw, nail or post.
[0015] In yet another and/or alternative aspect of the present
invention, the one or more access openings in the surface of the
screw, nail or post allow insertion of one or more substances into
one or more cavities of the screw, nail or post; allow one or more
substances to exit the one or more cavities of the screw, nail or
post; and/or to allow body fluids and/or bone growth into the one
or more access openings and/or into the one or more cavities. In
one embodiment of the present invention, a plurality of cavities
includes at least one access opening. In another and/or alternative
embodiment of the present invention, at least one access opening
can be used by the manufacturer and/or physician to inserted one or
more substances into one or more cavities. As can be appreciated, a
physician can add a substance into the cavity just prior to,
during, and/or after the insertion of the screw, nail, or post in
the bone and/or cartilage. As can further be appreciated, a
physician can add a substance into the cavity after the surgery has
been completed and the patient is recovering from the surgery. In
such a situation, the cavity can be periodically replenished with
the same or different substance to facilitate in the recovery of
the patient. In still another and/or alternative embodiment, the
size of one or more of the access openings is selected to control
or regulate the flow of substances into and/or out of the one or
more access openings.
[0016] In still yet another and/or alternative aspect of the
present invention, a cap and/or cover is applied over one or more
access openings. The cap or cover is designed to at least partially
seal one or more substances in the one or more cavities and/or
access openings, and/or to at least partially control the release
of one or more substances from the one or more cavities. In one
embodiment of the invention, the cap or cover is be made of a
biodegradable and/or non-biodegradable material. In one aspect of
this embodiment, the cap and/or cover is at least partially made of
a biodegradable material which at least partially dissolves after
the screw, nail or post has been implanted thereby at least
partially providing access to the access opening over time. In
another and/or alternative embodiment of the invention, the cap
and/or cover can be inserted prior to, during, and/or after the
insertion of the screw, nail, or post in the bone and/or cartilage.
In still another and/or alternative embodiment of the invention,
the cap and/or cover can be designed to be at least partially
removed prior to, during, and/or after the insertion of the screw,
nail, or post in the bone and/or cartilage. In yet another and/or
alternative embodiment of the invention, the cap and/or cover is at
least partially made of a material that allows one of more
substances and/or body fluids to penetrate the cap or cover. In
still yet another and/or alternative embodiment of the present
invention, the cap and/or cover material includes, but is not
limited to, metals, wood, fabric, carbon and/or glass fibers,
polymers; copolymers; human tissue; animal tissue; synthetic
tissue; human cells; animal cells; synthetic cells; and/or
bone-stimulation, bone-growth and/or bone activating matter. In a
further and/or alternative embodiment of the present invention, the
cap and/or cover can be applied to the screw, nail or post is a
number of ways (e.g., dipping, spraying, ionizing, painting,
adhesive, screwing, snapping, locking, tacking, soldering, melting,
etc.).
[0017] In a further and/or alternative aspect of the invention, the
screw, nail or post includes one or more outer surface regions that
are coated with one or more substances. In one embodiment of the
present invention, the one or more substances include, but are not
limited to, a substance that a) promotes and/or inhibits bone
and/or other tissue growth, b) inhibits rejection of the screw,
nail or post, c) inhibits rejection of components connected to
and/or located adjacent to the screw, nail or post, d) reduces
infection, e) reduces inflammation, f) reduces pain, g) provides
vitamins, minerals, and/or nutrients, h) provides genetic material,
i) provides tissue, j) facilitates in the insertion, positioning,
and/or removal of the screw, nail or post from bone and/or
cartilage (e.g. lubricant, Teflon, graphite, etc.), k) secures the
screw, nail or post in the bone and/or cartilage (e.g. bone cement
or other adhesive, etc.), l) promotes healing of surrounding
tissue, m) combats cancer and/or other diseases, n) combats and/or
cures biological abnormalities (e.g. chemical imbalance, etc.), o)
functions as a location and/or visual indicator, and/or the like.
Typically, the one or more coated substances is selected to improve
the success of retaining the screw, nail, or post into the bone
and/or cartilage. In another and/or alternative embodiment of the
present invention, the coating includes a single type of substance.
In still another and/or alternative embodiment of the present
invention, the coating includes a multiple types of substances. In
another and/or alternative embodiment of the present invention, the
surface of the screw, nail or post that includes the one or more
substances is smooth, rough (e.g., ribs, canals, pits, teeth,
ridges, grooves, holes, notches, slits, slots, channels,
corrugations etc.), porous and/or non-porous. In yet another and/or
alternative embodiment of the present invention, the coating is
smooth and/or rough. In still yet another and/or alternative
embodiment of the present invention, the coating includes a
compound that at least partially controls the release of the one or
more substances from the coating. The compound can be biodegradable
or non-biodegradable. In still yet another and/or alternative
embodiment of the present invention, the coating facilitates the
insertion and/or securing of the screw into bone and/or cartilage.
In one aspect of this embodiment, the coating is a biocompatible
material. In another and/or alternative aspect of this embodiment,
the coating includes polytetrafluoroethylene, or polymers and/or
co-polymers that includes polytetrafluoroethylene, a natural and/or
synthetic bone cement; polymer, co-polymer and/or urethane foam;
autologous growth compound; powdered bone, bone and/or other tissue
growth stimulating substances; polyglycolate polymers and/or
analogues; lactides; polydioxamone; polyglycolate;
lactide/glycolide copolymers; and/or other tissue growth inhibiting
compounds; and/or other substances (e.g., antithrombogenic agents;
steroids; thioprotese inhibitors; antimicrobials; antibiotics;
tissue plasma activators; monoclonal antibodies; antifibrosis
compounds; hormones; growth factors; anti-mitotic agents;
immunosuppressive agents; sense or antisense oligonucleotides;
nucleic acid analogues; inhibitors of transcription factor
activity; anti-neoplastic compounds; chemotherapeutic compounds;
radioactive agents; growth factors; antiplatlet compounds;
antitabolite compounds; anti-inflammatory compounds; anticoagulent
compounds; antimitotic compounds; antioxidants; antimetabolite
compounds; anti-migratory agents; anti-matrix compounds; anti-vital
compounds; anti-proliferatives; anti-fungal compounds;
anti-protozoal compounds; human tissue; animal tissue; synthetic
tissue; human cells; animal cells; synthetic cells; and/or
bone-stimulation, bone-growth and/or bone activating matter; etc.).
In a further embodiment of the present invention, the coated
material can be applied to the screw, nail or post by adhesive
bonding, welding, soldering, shrink wrapping, melting, spray
coating, ionization, hot dipping, electroplating, immersion
coating, brush coating, and/or the like. In another embodiment, the
coating material enhances the strength and/or durability of the
screw, nail or post and/or hardens or softens the surface of the
screw, nail or post. In still and/or alternative embodiment of the
present invention, the one or more coatings of one or more
substances are partially or fully coated on the surface of the
screw, nail or post.
[0018] In another and/or alternative aspect of this invention, the
screw, nail or past includes at least one opening or mounting
member used to connect and/or secure a) one or more devices to
anchor and/or affix one or more components of the implant (e.g.
rod, cage, stabilization system, screw, post, etc.), and/or b) one
or more components of the screw, nail or post (e.g. connect head to
lower portion of screw, nail or post; connect an electrical and/or
electronic component to the screw, nail or post; connect a
mechanical component to the screw, nail or post; etc.). the one or
more opening can be an access opening as described above, or some
other opening. The one or more mounting members can be, but are not
limited to, a ridge, groove, slot, etc. The one or more openings or
mounting members can be positioned on the head and/or lower portion
of the screw, nail or post.
[0019] In yet another and/or alternative aspect of the invention,
the screw, nail or post includes one or more mechanical and/or
electrical devices that at least partially cause and/or control the
release of one or more substances from the screw, nail or post. In
one embodiment of the present invention, the mechanical and/or
electrical device can be designed to cause and/or control the
release of one or more substances based upon, but not limited to,
a) a preprogrammed schedule, b) a function of time, c) a
predetermined rate, d) and/or receipt of an external signal. In one
aspect of this embodiment, the mechanical and/or electrical device
is preprogrammed to allow and/or cause the release one or more
substances from the screw, nail or post during one or more time
periods. In one non-limiting design, the mechanical and/or
electrical device includes a microchip that at least partially
stores a program that allows and/or causes the release one or more
substances from the screw, nail or post. In one particular design,
the mechanical and/or electrical device includes one or more MEMS
(micro-electro-mechanical systems). The MEMS include both the
preprogramming and the mechanism to allow and/or cause the release
one or more substances from the screw, nail or post. In another
and/or alternative particular design, the microchip at least
partially controls a separate mechanical and/or electrical device
(e.g., valve, pump, motor, etc.) which in turn allows and/or causes
the release one or more substances from the screw, nail or post. In
still another and/or alternative particular design, the microchip
can be preprogrammed and/or reprogrammed prior to, during and/or
after the insertion of the screw, nail or post. As can be
appreciated, the parameters for allowing and/or causing the release
of one or more substances can be altered by reprogramming (e.g.,
new data, additional data, new source code, additional source code,
etc.) during the healing process of a patient, thus are
individualized for a patient. Consequently, the setting for the
mechanical and/or electrical device can be changed, as medical
treatment needs dictate (e.g. greater or lesser amounts of
substance discharge, different substance discharge ratios, more
frequent substance discharge, etc.). In yet another and/or
alternative particular design, the microchip can be activated prior
to, during and/or after the insertion of the screw, nail or post.
In another and/or alternative aspect of this embodiment, the
external signal includes, but is not limited to, an electrical
signal, magnetic signal, electromagnetic wave signal (e.g. light,
radio wave, microwave, x-ray, infrared light, ultraviolet light,
etc.), heat signal, vibration signal, chemical signal, mechanical
signal, etc. In yet another and/or alternative embodiment of the
present invention, a transmitter (e.g. wire, fiber optic cable,
electromagnetic wave transmitter, etc.) is connected between the
screw, nail or post and at or near the surface of the patient's
body and/or some other location, which transmitter allows a signal
to be transmitted from a remote location to the screw, nail or
post. In one aspect of this embodiment, the signal can a) transmit
a signal to the mechanical or electrical device in the screw, nail
or post; and/or b) provide instructions and/or programming to the
mechanical or electrical device in the screw, nail or post. In
still yet a further and/or alternative embodiment of the present
invention, the mechanical and/or electrical device can be activated
prior to, during, or after the insertion of the screw, nail or post
in the bone and/or cartilage. In another and/or alternative aspect
of this embodiment, one or more contact points are located at or
near the surface of the skin of a human or animal, which one or
more contacts are connected between a contact surface of the
contact points and the screw, nail or post, and/or one or more
components connected to the screw, nail or post. In still another
and/or alternative aspect of this embodiment, the screw, nail or
post, and/or one or more components connected to the screw, nail or
post, includes an electromagnetic wave transmitter and/or receiver
which can send and/or receive signals in the form of
electromagnetic waves. In still yet a further and/or alternative
embodiment of the present invention, the mechanical and/or
electrical device can be activated prior to, during, or after the
insertion of the screw, nail or post in the bone and/or cartilage.
In still a further and/or alternative embodiment of the invention,
the mechanical and/or electrical device can at least partially
control the location of substance discharge on the screw, nail or
post; and/or control the amount and/or frequency of substance
discharge on various regions of the screw, nail or post. In one
aspect of this embodiment, the mechanical and/or electrical device
can open and/or close one or more access openings, and/or cause one
or more substances to flow into and/or out of one or more cavities.
In still another and/or alternative embodiment, the amount of
substance discharge from the screw, nail or post is at least about
0.001 milliliters per discharge, and generally about 0.002-20
milliliters per discharge; however, other discharge amounts can
occur.
[0020] In still yet another and/or alternative embodiment of the
present invention, the screw, nail or post is designed such that
one or more cavities can be filled and/or refilled with one or more
substances after being inserted in bone and/or cartilage. The
filling and/or refilling of one or more cavities in the screw, nail
or post facilitates in an ongoing or a sequence of therapies that
can be applied at and/or contiguous to the site of insertion of the
screw, nail or post. In one embodiment of the present invention,
the screw, nail or post includes one or more access openings
designed to receive an end of a syringe or other device that is
adapted to insert a substance in the access opening. In another
and/or alternative embodiment of the present invention, a tube is
connected between the screw, nail or post and the surface of the
patient's body, which tube includes an opening designed to receive
an end of a syringe or other device adapted to insert a substance
in the tube opening which in turn conveys the substance to an
access opening in the screw, nail or post.
[0021] In still a further and/or alternative embodiment of the
present invention, the screw, nail or post includes one or more
mechanisms to promote bone healing about the screw, nail or post
and/or adjacent to the screw, nail or post. In one embodiment of
the present invention, the screw, nail or post applies an
electrical charge on or about the screw, nail or post. Electrical
stimulation has been found, in certain situations, to promote the
healing of bone and/or other tissue. The use of such electrical
stimulation can promote the healing of bone and/or cartilage about
the screw, nail or post. In another and/or alternative embodiment
of the present invention, the screw, nail or post includes one or
more mechanical and/or electrical devices that at least partially
control the duration, timing and/or degree of electrical
stimulation from the screw, nail or post. In one aspect of this
embodiment, the mechanical and/or electrical device can be designed
to control the duration, timing and/or degree of electrical
stimulation based upon a preprogrammed sequence, as a function of
time, and/or upon receipt of an external signal. In one
non-limiting design, the mechanical and/or electrical device is
preprogrammed to control the duration, timing and/or degree of
electrical stimulation from the screw, nail or post. In one
particular non-limiting design, the mechanical and/or electrical
device includes a microchip that at least partially stores a
program that allows and/or causes the occurrence of an electrical
stimulation from the screw, nail or post. In another and/or
alternative non-limiting particular design, the mechanical and/or
electrical device includes one or more MEMS
(micro-electro-mechanical systems). The MEMS includes both the
preprogramming and the mechanism that allows and/or causes the
occurrence of an electrical stimulation from the screw, nail or
post. In still another and/or alternative non-limiting particular
design, the microchip at least partially controls a separate
mechanical and/or electrical device (e.g. battery, electric
generator, etc.) which in turn allows and/or causes an electrical
simulation to occur. In still another and/or alternative
non-limiting particular design, the microchip can be preprogrammed
and/or reprogrammed prior to, during and/or after the insertion of
the screw, nail or post. As can be appreciated, the parameters for
electrical stimulation can be altered by reprogramming (e.g., new
data, additional data, new source code, additional source code,
etc.) during the healing process of a patient, thus are
individualized for a patient. Consequently, one or more settings
for the mechanical and/or electrical device can be changed, as
medical treatment needs dictate (e.g. greater or lesser
stimulation, a more frequent electrical discharge, adjustments of
time and/or power of electrical discharge, etc.). In yet another
and/or alternative non-limiting particular design, the microchip
can be activated prior to, during and/or after the insertion of the
screw, nail or post. In another and/or alternative aspect of this
embodiment, the external signal includes, but is not limited to, an
electrical signal, magnetic signal, electromagnetic wave signal
(e.g. light, radio wave, microwave, x-ray, infrared light, etc.),
heat signal, vibration signal, chemical signal, mechanical signal,
etc. In another and/or alternative embodiment of the invention,
mechanical and/or electrical component can be charged prior to,
during and/or after insertion of the screw, nail or post. In still
another and/or alternative embodiment of the invention, mechanical
and/or electrical component can be recharged after insertion of the
screw, nail or post. In yet another and/or alternative embodiment
of the present invention, a transmitter (e.g. wire, fiber optic
cable, electromagnetic wave transmitter, etc.) is connected between
the screw, nail or post and at or near the surface of the patient's
body and/or some other location, which transmitter allows an
electrical current and/or signal to be transmitted from a remote
location to the screw, nail or post. In one aspect of this
embodiment, the electrical current and/or signal can a) transmit a
signal to the mechanical or electrical device in the screw, nail or
post; b) recharge the mechanical and/or electrical device in the
screw, nail or post; c) provide instructions and/or programming to
the mechanical or electrical device in the screw, nail or post; d)
generates and/or causes electrical simulation to be generated from
the screw, nail or post. In another and/or alternative aspect of
this embodiment, one or more contact points are located at or near
the surface of the skin of a human or animal, which one or more
contacts are connected between a contact surface of the contact
points and the screw, nail or post, and/or one or more components
connected to the screw, nail or post. In still another and/or
alternative aspect of this embodiment, the screw, nail or post,
and/or one or more components connected to the screw, nail or post,
include an electromagnetic wave transmitter and/or receiver which
can send and/or receive signals in the form of electromagnetic
waves. In still yet a further and/or alternative embodiment of the
present invention, the mechanical and/or electrical device can be
activated prior to, during, or after the insertion of the screw,
nail or post in the bone and/or cartilage. In a further and/or
alternative embodiment of the invention, the electrical stimulation
is at least partially generated by a battery, chemical reaction,
generator, magnetic field, electric current, and/or the like. In
still a further and/or alternative embodiment of the invention, the
mechanical and/or electrical device can at least partially control
the location of discharge on the screw, nail or post; and/or
control the degree and/or frequency of discharge on various regions
of the screw, nail or post. In one aspect of this embodiment, the
mechanical and/or electrical device can relocate the location of
electrical discharge on the screw, nail or post to promote healing
in specified regions about the screw, nail or post. In another
and/or alternative aspect of this embodiment, the mechanical and/or
electrical device can regulate the amount of electrical discharge
from one or more regions on the screw, nail or post to promote
healing in specified regions about the screw, nail or post. In
still another and/or alternative embodiment, the amount of voltage
discharge from the screw, nail or post is at least about 1
microvolt per discharge, and generally about 5 microvolts to about
12 volts per discharge; however, other voltage amounts can be used.
In yet another and/or alternative embodiment, the amount of current
discharge from the screw, nail or post is at least about 1
microampere per discharge, and generally about 2 microamperes to
about 0.1 amperes per discharge; however, other amperages can be
used.
[0022] In yet a further and/or alternative aspect of the present
invention, the screw, nail or post can be designed to be left in
place for an indeterminate time after completion of surgery and
post-surgical healing and/or can be removed at some time after the
completion of surgery, or be replaced during ongoing therapy and/or
treatment.
[0023] In still yet a further and/or alternative aspect of the
present invention, the screw, nail or post is designed to be
connected to a mechanical and/or electrical device which mechanical
and/or electrical device at least partially regulates and/or
controls the discharge of a substance and/or electrical current
from at least a portion of the screw, nail or post. In one
embodiment of the present invention, the mechanical and/or
electrical device is connected to the screw, nail or post prior to,
during or after insertion of the screw, nail or post into the bone
and/or cartilage. In another and/or alternative embodiment of the
present invention, the mechanical and/or electrical device is
detachable from the screw, nail or post prior to, during or after
insertion of the screw, nail or post into the bone and/or
cartilage. In one aspect of this embodiment, the mechanical and/or
electrical device can be replaced when it breaks, malfunctions,
and/or has completed its useful life, without having to fully or
partially remove the screw, nail or post from the bone and/or
cartilage. In still another and/or alternative embodiment of the
present invention, the screw, nail or post includes one or more
openings, connection locations, and/or contact points for the
connection of one or more mechanical and/or electrical devices to
the screw, nail or post. The one or more openings, connection
locations, and/or contact points can function to secure the
mechanical and/or electrical device to the screw, nail or post,
and/or to integrate the mechanical and/or electrical device with
one or more cavities and/or other mechanical and/or electrical
devices in the screw, nail or post.
[0024] In another and/or alternative aspect of the present
invention, the screw, nail or post is designed such that a
mechanical and/or electrical device at least partially regulates
and/or controls the discharge of a substance and/or electrical
current from at least a portion of the screw, nail or post is at
least partially formed and/or positioned in the screw, nail or
post. In one embodiment of the present invention, the majority of
the mechanical and/or electrical device is embedded in the screw,
nail or post prior to, during or after insertion of the screw, nail
or post into the bone and/or cartilage. In another and/or
alternative embodiment of the present invention, at least a portion
of the mechanical and/or electrical device is connected to a
portion of the mechanical and/or electrical device that is already
at least partially formed and/or positioned in the screw, nail or
post.
[0025] In still another and/or alternative aspect of the present
invention, the screw, nail or post is formed of a substantially
inert or biologically compatible material for use in humans. In one
embodiment of the present invention, the screw, nail or post is
designed to be used with a prosthetic implant that is designed to
be placed in the intervertebral disc space that was formerly
occupied by at least a portion of an intervertebral disc. In still
another and/or alternative embodiment of the present invention, the
prosthetic implant is designed to be readily inserted by
established surgical procedures, with minimal chances of surgical
difficulty. In yet another and/or alternative embodiment of the
present invention, the screw, nail or post includes, but is not
limited to, bone, stainless steel, titanium, chromemolybdenum,
cobalt chromium alloy, chrome or chrome alloys, cobalt or cobalt
alloys, polycarbonate, polypropylene, polyethylene,
polymethylmethacrylate, polysolfone types filled with glass and/or
carbon fibers, and various types of carbon and fiber reinforced
polymers. In one aspect of this embodiment, the material is wear
resistant.
[0026] In accordance with yet another and/or alternative aspect of
the present invention, the screw, nail or post includes one or more
openings in the head and/or lower portion to facilitate in the
positioning of the screw, nail or post relative to the bone or
cartilage and/or to secure the screw, nail or post in the bone
and/or cartilage. In one embodiment of the present invention, one
or more of the openings in the screw, nail or post is adapted to
receive an instrument for guiding, inserting, and/or removing the
screw, nail or post in the bone and/or cartilage.
[0027] In accordance with still yet another and/or alternative
aspect of the present invention, the screw, nail or post is at
least partially connected to bone and/or cartilage after an opening
in the bone and/or cartilage has been formed. Typically, the hole
is formed by a drill or similar device. The size of the opening is
typically selected to be smaller than the cross-sectional area of
the screw, nail, or post; however, this is not required. The
opening is typically inserted in the bone and/or cartilage to
reduce damage to the bone and/or cartilage when the screw, nail or
post is subsequently inserted in the bone and/or cartilage, and/or
to provide a guide opening for insertion of the screw, nail or
post.
[0028] It is an object of the present invention to provide an
improved screw, nail or post for insertion into bone and/or
cartilage.
[0029] It is another and/or alternative object of the present
invention to provide a screw, nail or post that can be easily and
efficiently positioned into bone and/or cartilage and which reduces
the failure rate of prosthetic implants.
[0030] It is still another and/or alternative object of the present
invention to provide a screw, nail or post for securing a rod or
elongate member from rotational and translational movement within a
bone and/or cartilage.
[0031] It is yet another and/or alternative object of the present
invention to provide a screw, nail or post which is relatively
small and which can be readily manipulated.
[0032] It is still yet another and/or alternative object of the
present invention to provide a screw, nail or post that can be
manufactured with present conventional technology.
[0033] It is a further and/or alternative object of the present
invention to provide a screw, nail or post that is designed to
simplify the insertion and fixing of a prosthetic implant.
[0034] It is still a further and/or alternative object of the
present invention to provide a screw, nail or post that is
relatively easy to manufacture and cost effective to
manufacture.
[0035] It is yet a further and/or alternative object of the present
invention to provide a screw, nail or post that includes one or
more cavities which is used to alter the weight distribution of the
screw, nail or post; alter the structural integrity of the screw,
nail or post; to at least partially contain a substance such as,
but not limited to, a material that a) promotes and/or inhibits
bone and/or other tissue growth, b) inhibits rejection of the
screw, nail or post, c) inhibits rejection of components connected
to and/or located adjacent to the screw, nail or post, d) reduces
infection, e) reduces inflammation, f) reduces pain, g) provides
vitamins, minerals, and/or nutrients, h) provides genetic material,
i) provides tissue, j) facilitates in the insertion, positioning,
and/or removal of the screw, nail or post from bone and/or
cartilage (e.g. lubricant, Teflon, graphite, etc.), k) secures the
screw, nail or post in the bone and/or cartilage (e.g. bone cement
or other adhesive, etc.), l) promotes healing of surrounding
tissue, m) combats cancer and/or other diseases, n) combats and/or
cures biological abnormalities (e.g. chemical imbalance, etc.), o)
functions as a location and/or visual indicator, and/or the like,
and/or to at least partially contain one or more electrical and/or
mechanical components.
[0036] It is still yet a further and/or alternative object of the
present invention to provide a screw, nail or post that includes at
least one cavity that has at least one access opening to the
surface of the screw, nail or post.
[0037] It is another and/or alternative object of the present
invention to provide a screw, nail or post that allows for
insertion of one or more substances into one or more cavities of
the screw, nail or post; that allows one or more substances to exit
the one or more cavities of the screw, nail or post; and/or that
allows body fluids and/or bone growth into the one or more access
openings and/or into the one or more cavities.
[0038] It is still another and/or alternative object of the present
invention to provide a screw, nail or post that allows a physician
to insert one or more substances into one or more cavities prior
to, during, and/or after the insertion of the screw, nail, or post
in the bone and/or cartilage.
[0039] It is yet another and/or alternative object of the present
invention to provide a screw, nail or post that includes a cap
and/or cover that is applied over one or more access openings which
is designed to at least partially seal one or more substances in
the one or more cavities, and/or to at least partially control the
release of one or more substances from the one or more
cavities.
[0040] It is still yet another and/or alternative object of the
present invention to provide a screw, nail or post that includes
one or more outer surface regions that are coated with one or more
substances.
[0041] It is a further and/or alternative object of the present
invention to provide a screw, nail or post that includes one or
more mechanical and/or electrical devices that at least partially
control the release of one or more substances from the screw, nail
or post.
[0042] It is still a further and/or alternative object of the
present invention to provide a screw, nail or post that is designed
such that one or more cavities can be filled and/or refilled with
one or more substances after being inserted in bone and/or
cartilage.
[0043] It is yet a further and/or alternative object of the present
invention to provide a screw, nail or post that applies an
electrical charge on or about the screw, nail or post.
[0044] These and other objects of the invention will become
apparent to those skilled in the art upon reading and understanding
the following detailed description of preferred embodiments taken
together with the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0045] The invention may take physical form in certain parts and
arrangement of parts, preferred embodiments of which will be
described in detail and illustrated in the accompanying drawings
which form a part hereof and wherein:
[0046] FIG. 1 is a partial perspective view of the front side
pedicle screw of the present invention which includes a pump
mechanism connected to top of the pedicle screw;
[0047] FIG. 2 is a perspective view of the back side of the pedicle
screw of FIG. 1;
[0048] FIG. 3 is another partial perspective view of the front side
pedicle screw of the present invention which includes a pump
mechanism connected to top of the pedicle screw wherein the pump is
oriented in a different position on the pedicle screw;
[0049] FIG. 4 is a perspective view of the back side of the pedicle
screw of FIG. 3;
[0050] FIG. 5 is still another perspective view of the front side
pedicle screw of the present invention which includes a pump
mechanism positioned in the top of the pedicle screw;
[0051] FIG. 6 is a partial perspective view of the front side
pedicle screw of the present invention which includes a electrical
mechanism connected to top of the pedicle screw;
[0052] FIG. 7 is a perspective view of the back side of the pedicle
screw of FIG. 6; and,
[0053] FIG. 8 is still another perspective view of the front side
pedicle screw of the present invention which includes an electrical
mechanism positioned in the top of the pedicle screw.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0054] Referring to the drawings, wherein the showings are for the
purpose of illustrating the preferred embodiment of the invention
only and not for the purpose of limiting same, FIG. 1 illustrates a
novel pedicle screw 10 for insertion into bone and/or cartilage.
The pedicle screw will be describe with particular reference for
use with surgical procedure involving the vertebra; however, it
will be appreciated that the pedicle screw can be used in other
regions of a body (e.g., leg, arm, hand, foot, pelvis, rib cage,
scull, etc.) to promote healing in such regions.
[0055] Orthopedic surgeons, as well as neurosurgeons, have long
recognized the need for the use of pedicle screws in the treatment
of spinal pathologies, deformities and traumas. The pedicle screws
are typically placed in the vertebral pedicle since this area has
been long recognized as the "force nucleus" of the spinal vertebra,
i.e. the area of the spine where a force applied to the bone by
pedicle screw would have the highest mechanical advantage in
repositioning the bone. The pedicle screw can be used by a surgeon
in other procedures, such as anchoring tissue or in bone plating
systems.
[0056] Referring again to FIG. 1, the pedicle screw 10 is
fabricated of a well known biocompatible material such as stainless
steel or titanium, and has a head 20 and a lower portion 30. The
particular material or materials selected will generally depend on
the location of the pedicle screw and the various objectives to be
accomplished by the pedicle screw. Head 20 has a hexagonal
cross-sectional shaped top portion to facilitate in the insertion
of the pedicle screw into the bone and/or cartilage. As can be
appreciated, other shapes of the top portion can be used (e.g.,
octagonal, triangular, square, etc.). As can also be appreciated,
the top portion 22 can include one or more indentations, slots,
ridges, openings, etc. to facilitate in the insertion of the
pedicle screw into the bone and/or cartilage. Positioned below the
hexagonal top portion is a conical shaped portion 24 that
terminates at the lower portion 30 of the pedicle screw. The lower
portion of the pedicle screw includes an outer surface 32 that
includes thread 34. The cross-sectional shape of the lower portion
is substantially circular and has a substantially constant
cross-sectional shape and cross-sectional area throughout the
majority of the longitudinal length of the lower portion. The end
36 of the lower portion as illustrated in FIG. 2 tapers to a point;
however, the end 36 can have a substantially flat configuration
and/or have a non-tapering configuration. As can be appreciated,
many other shapes and/or configurations of the head and/or lower
portion can be used for the pedicle screw in the present
invention.
[0057] In utilizing the pedicle screw, the pedicle screw is
typically inserted into the bone and/or cartilage that includes a
tapped or pre-drilled hole formed therein as a guide for the
placement of the screw. The bone has a relatively hard compact
shell, which encases a loose spongy cancellous bone material. The
tap or pre-drilled hole facilitates in the insertion of the pedicle
screw into the bone and/or minimizes damage to the bone during the
insertion of the pedicle screw. Typically the tap or pre-drilled
hole has a diameter that is less than the threads 34 on the lower
portion 30 of the pedicle screw. For example, the tap or
pre-drilled hole may have a diameter of about 8 mm, and the threads
on the lower portion of the pedicle screw have a diameter of about
8.5 mm. The tap hole or pre-drilled hole forms a precise, preset
path of insertion for the pedicle screw. Since the threads have a
larger diameter that the opening in the bone and/or cartilage, the
thread 34 bites into the bone and/or cartilage thereby accurately
positioning the pedicle screw in the bone and/or cartilage and
securing the pedicle screw in the bone and/or cartilage. Typically
the pedicle screw is adapted for use in securing a plate, rod
and/or the like, not shown, from translational or rotational
motion.
[0058] Referring again to FIG. 1, a mechanical mechanism 40 is
connected to top portion 22. The mechanical mechanism can be
connected to the top portion is a variety of way such as, but not
limited to, screw, bolt, solder, weld, latch, snap, clip, etc. The
connection can be designed to allow the mechanical mechanism to be
at least partially connected to the top portion prior to, during,
and/or after the pedicle screw has been inserted into the bone
and/or cartilage. Alternatively and/or additionally, the connection
can be designed to allow the mechanical mechanism to be at least
partially removably connected to the top portion of the pedicle
screw. Still alternatively and/or additionally, the connection can
be designed to be at least partially irremovably connect one or
more components of the mechanical mechanism to the top portion of
the pedicle screw.
[0059] As illustrated in FIGS. 1 and 2, mechanical mechanism 40
includes a pump 42 and a cylinder 44 that is connected between pump
42 and top portion 22 of head 20. The pump can have any number of
different configurations and/or can operate in any number of
different ways. The pump is specifically designed to cause a
substance contained in the cylinder to flow out of the cylinder. In
one non-limiting configuration, the pump includes a piston that at
least partially travels into the cylinder to cause one or more
substances in the cylinder to flow out of the cylinder.
[0060] The substance in the cylinder can include a variety of
materials that promote bone and/or other tissue growth, inhibit
rejection of the prosthetic implant, reduce infection, reduce
inflammation, reduce pain, promote healing of surrounding tissue,
function as a location and/or visual indicator, and/or the like.
Such substances include, but are not limited to, antithrombogenic
agents; steroids; thioprotese inhibitors; antimicrobials;
antibiotics; tissue plasma activators; monoclonal antibodies;
antifibrosis compounds; hormones; growth factors; anti-mitotic
agents; immunosuppressive agents; sense or antisense
oligonucleotides; nucleic acid analogues; inhibitors of
transcription factor activity; anti-neoplastic compounds;
chemotherapeutic compounds; radioactive agents; growth factors;
antiplatlet compounds; antitabolite compounds; anti-inflammatory
compounds; anticoagulent compounds; antimitotic compounds;
antioxidants; antimetabolite compounds; anti-migratory agents;
anti-matrix compounds; anti-vital compounds; anti-proliferatives;
anti-fungal compounds; anti-protozoal compounds; human tissue;
animal tissue; synthetic tissue; human cells, animal cells;
synthetic cells; and/or bone-stimulation, bone-growth and/or bone
activating matter.
[0061] Once the pedicle screw is connected to the bone and/or
cartilage, the mechanical mechanism can be activated so that the
pump causes one or more substances in the cylinder to flow out of
the cylinder. The mechanical mechanism can alternatively be
activated prior to complete insertion of the pedicle screw into the
bone and/or cartilage. The activation of the mechanical mechanism
can be manual and/or by a preprogrammed activation mechanism. The
rate at which the pump causes one or more substances in the
cylinder to flow out of the cylinder can be constant or manually
and/or electronically regulated to vary over time.
[0062] Referring again to FIG. 1, the lower portion 30 of pedicle
screw 10 includes two openings 38. As can be appreciated, more or
less openings can be located in the lower portion. Furthermore, it
can be appreciated that one or more openings can be located in the
top portion of the pedicle screw. The openings are designed to
allow at least a portion of the one or more substances in the
cylinder 44 to flow out of the openings 38 and to the surrounding
bone and/or cartilage. The top portion of the pedicle screw
includes one or more openings, not shown, which allows the one or
more substances from the cylinder 44 to flow into the one or more
openings in the top portion and into one of more interior channels
in the top portion, not shown. These one or more channels in the
top portion allow the one or more substances to flow through the
top portion and into one or more channels in the lower portion, not
shown, and out through openings 38. The two or more openings can be
positioned on the same side of the pedicle screw as illustrated in
FIG. 1, or positioned in the lower portion in other manners.
[0063] Referring now to FIGS. 3 and 4, another embodiment of the
invention is illustrated. Pump 40 is shown to be attached to
cylinder 44 so that the pump does not extend longitudinally above
the cylinder. In this configuration, the pump does not extend as
far outward from the pedicle screw. Such a pump orientation can
facilitate the use of this embodiment in regions of the spine
wherein the orientation of the pump as illustrated in FIGS. 1 and 2
may interfere with the surrounding tissue. As can be appreciated,
pump 40 can be orientated in a variety of other manners to
facilitate the use of the pump and successful use of the pedicle
screw. FIGS. 3 and 4 also illustrates a flange 46 positioned on
cylinder 44. The flange 46 allows one or more substances to be
added to and/or removed from the cylinder prior to, during and/or
after the pedicle screw is inserted into the bone and/or cartilage.
The flange 46 can also be used to refill the cylinder.
[0064] Referring now to FIG. 5, still another embodiment of the
invention is illustrated. Pedicle screw 50 includes a head 60 and a
lower portion 80. The cross-section of head 60 illustrates that the
head includes one or more reservoirs 62 for containing one or more
substances described above. The reservoir is illustrated as having
an ovoid shape; however, other shapes can be used. The top 64 of
head 60 includes one or more port openings 66. Port opening 66
allows one or more substances to be inserted and/or removed from
reservoir 62. One or more port passages 68 allows fluid passage
between port opening 66 and reservoir 62. The port opening may have
a sealing member to inhibit or prevent one or more substances in
the reservoir from freely flowing out of the reservoir and out
through port opening 66. One or more motors 70 are positioned in
head 60. Motor 70 can be any type of motor that is small enough to
be substantially fully positioned in the head. One non-limiting
motor is a MEMS device. The head also includes one or more pressure
plates 72 designed to be moved by motor 70 to thereby cause the one
or more substances in reservoir 62 to flow out of the reservoir.
One or more discharge ports 74 allow one or more substances to flow
from the reservoir and into a base chamber 76 of head 60.
[0065] The lower portion 80 of the pedicle screw includes an outer
surface 82 that includes thread 84. The cross-sectional shape of
the lower portion is substantially circular and has a substantially
constant cross-sectional shape and cross-sectional area throughout
the majority of the longitudinal length of the lower portion. The
end 86 of the lower portion is substantially flat. As can be
appreciated, many other shapes and/or configurations of the head
and/or lower portion can be used for the pedicle screw. The lower
portion also includes three openings 88. As can be appreciated,
more or less openings can be located in the lower portion.
Furthermore, it can be appreciated that one or more openings can be
located in the top portion of the pedicle screw. The openings are
designed to allow at least a portion of the one or more substances
to flow out of the openings 88 and to the surrounding bone and/or
cartilage. The lower portion also includes one or more channels 90
to allow the one or more substances to flow from base chamber 76 of
head 60 and out through openings 88. The two or more openings can
be positioned on the same side of the pedicle screw as illustrated
in FIG. 5, or be positioned on the lower portion in other
manners.
[0066] As stated above, once the pedicle screw is connected to the
bone and/or cartilage, the mechanical mechanism can be activated so
that the pump causes one or more substances to flow out of openings
88. The mechanical mechanism can alternatively be activated prior
to complete insertion of the pedicle screw into the bone and/or
cartilage. The activation of the mechanical mechanism can be manual
and/or by a preprogrammed activation mechanism. The rate at which
the pump causes one or more substances in the cylinder to flow out
of the cylinder can be constant or be manually and/or
electronically regulated to vary over time.
[0067] Referring now to FIGS. 6 and 7, another embodiment of the
invention is disclosed. Pedicle screw 100 has a head 110 and a
lower portion 120. Head 110 has a hexagonal cross-sectional shaped
top portion 112 to facilitate in the insertion of the pedicle screw
into the bone and/or cartilage. As can be appreciated, other shapes
of the top portion can be used. As can also be appreciated, the top
portion 112 can include one or more indentations, slots, ridges,
openings, etc. to facilitate in the insertion of the pedicle screw
into the bone and/or cartilage. Positioned below the hexagonal top
portion is a conical shaped portion 114 that terminated at the
lower portion 120 of the pedicle screw. The lower portion of the
pedicle screw includes an outer surface 122 that includes thread
124. The cross-sectional shape of the lower portion is
substantially circular and has a substantially constant
cross-sectional shape and cross-sectional area throughout the
majority of the longitudinal length of the lower portion. The end
126 of the lower portion as illustrated in FIG. 7 tapers to a
point; however, the end 126 can have a substantially flat
configuration and/or have a non-tapering configuration. As can be
appreciated, many other shapes and/or configurations of the head
and/or lower portion can be used for the pedicle screw in the
present invention.
[0068] Referring again to FIG. 6, an electrical mechanism 130 is
connected to top portion 112. The electrical mechanism can be
connected to the top portion is a variety of way such as, but not
limited to, screw, bolt, solder, weld, latch, snap, clip, etc. The
connection can be designed to allow the electrical mechanism to be
at least partially connected to the top portion prior to, during,
and/or after the pedicle screw has been inserted into the bone
and/or cartilage. Alternatively and/or additionally, the connection
can be designed to allow the electrical mechanism to be at least
partially removably connected to the top portion of the pedicle
screw. Still alternatively and/or additionally, the connection can
be designed to be at least partially irremovably connect one or
more components of the electrical mechanism to the top portion of
the pedicle screw.
[0069] As illustrated in FIGS. 6 and 7, the electrical mechanism
includes a battery or electric generator 132 that is connected to
top portion 112 of head 110. The battery or electric generator can
have any number of different configurations and/or can operate in
any number of different ways. The battery or electric generator is
specifically designed to supply an electric current to one or more
surfaces of the pedicle screw. In one non-limiting configuration,
the electrical mechanism includes a battery to supply electric
current to one or more regions on the pedicle screw.
[0070] Once the pedicle screw is connected to the bone and/or
cartilage, the electrical mechanism can be activated so that the
battery or electric generator begins suppling electric current to
one or more regions on the pedicle screw. The electrical mechanism
can alternatively be activated prior to complete insertion of the
pedicle screw into the bone and/or cartilage. The activation of the
electrical mechanism can be manual and/or by a preprogrammed
activation mechanism. The rate at which the electrical mechanism
discharges electric current can be constant or manually and/or
electronically regulated to vary over time.
[0071] Referring again to FIG. 6, the lower portion 120 of pedicle
screw 100 includes two electrodes 128. As can be appreciated, more
or less electrodes can be located in the lower portion.
Furthermore, it can be appreciated that one or more electrodes can
be located in the top portion of the pedicle screw. The electrodes
are designed to conduct electrical current about the surrounding
bone and/or cartilage. The top portion of the pedicle screw
includes one or more regions, not shown, which allow current to be
conducted between the battery or electric generator and the two or
more electrodes in the lower portion. For example, the one or more
regions can be a passageway for containing and electrically
conducting material such as, but not limited to, a wire. The two or
more electrodes can be positioned on the same side of the pedicle
screw as illustrated in FIG. 6, or be positioned in the lower
portion in other manners.
[0072] Referring now to FIG. 8, still another embodiment of the
invention is illustrated. Pedicle screw 140 includes a head 150 and
a lower portion 160. The cross-section of head 150 illustrates that
the head includes a battery 152 positioned in top surface 154. The
battery is illustrated as having an cubical shape; however, other
shapes can be used. The head has a rectangular shape; however,
other shapes can be used. The battery can be connected in the head
in a variety of manners. The battery can also be connected such
that the battery can be periodically replaced. A channel 156 is
positioned under the battery and travels between the battery and
lower portion 160 of the pedicle screw. Typically a wire or other
electrical conductor is positioned in the channel. The discharge
rate, the discharge duration, etc. of the battery can be constant
or electronically controlled.
[0073] The lower portion 160 of the pedicle screw includes an outer
surface 162 that includes thread 164. The cross-sectional shape of
the lower portion is substantially circular and has a substantially
constant cross-sectional shape and cross-sectional area throughout
the majority of the longitudinal length of the lower portion. The
end 166 of the lower portion is substantially flat. As can be
appreciated, many other shapes and/or configurations of the head
and/or lower portion can be used for the pedicle screw. The lower
portion also includes two electrodes 168. As can be appreciated,
more electrodes can be located in the lower portion. Furthermore,
it can be appreciated that one or more electrodes can be located in
the top portion of the pedicle screw. The electrodes are designed
to conduct current between the electrodes and to the surrounding
tissue. The lower portion also includes one or more channels 170
wherein an electrical conductor is positioned. Channel 170 enables
an electrical conductor to connect the electrodes 160 to the
electrical conductor in channel 156. The electrodes can be
positioned on the same side of the pedicle screw as illustrated in
FIG. 8, or positioned on the lower portion in other manners.
[0074] As stated above, once the pedicle screw is connected to the
bone and/or cartilage, the electrical mechanism can be activated so
that the battery conducts a current between the electrodes. The
electrical mechanism alternatively can be activated prior to
complete insertion of the pedicle screw into the bone and/or
cartilage. The activation of the electrical mechanism can be manual
and/or by a preprogrammed activation mechanism. The discharge rate
at which the battery conducts current between the electrodes can be
constant or be manually and/or electronically regulated to vary
over time.
[0075] The invention has been described with reference to the
preferred embodiments. These and other modifications of the
preferred embodiments as well as other embodiments of the invention
will be obvious from the disclosure herein, whereby the foregoing
descriptive matter is to be interpreted merely as illustrative of
the invention and not as a limitation. It is intended to include
all such modifications and alterations insofar as they come within
the scope of the appended claims.
* * * * *