U.S. patent application number 11/952081 was filed with the patent office on 2008-07-31 for hard tissue anchors and delivery devices.
This patent application is currently assigned to SPINAL MODULATION, INC.. Invention is credited to Albert G. BURDULIS.
Application Number | 20080183221 11/952081 |
Document ID | / |
Family ID | 39493081 |
Filed Date | 2008-07-31 |
United States Patent
Application |
20080183221 |
Kind Code |
A1 |
BURDULIS; Albert G. |
July 31, 2008 |
HARD TISSUE ANCHORS AND DELIVERY DEVICES
Abstract
The present invention provides devices, systems and methods for
anchoring medical devices to hard tissues, such as bones or bony
structures, particularly vertebrae. By anchoring these medical
devices directly to the surrounding hard tissue, the devices are
anchored closer to the source of treatment. This provides
additional stability and reduces migration of the device at the
treatment site. Also, by attaching to hard tissue rather than soft
tissue, a stronger attachment is often able to be made.
Inventors: |
BURDULIS; Albert G.; (San
Francisco, CA) |
Correspondence
Address: |
SHAY GLENN LLP
2755 CAMPUS DRIVE, SUITE 210
SAN MATEO
CA
94403
US
|
Assignee: |
SPINAL MODULATION, INC.
Menlo Park
CA
|
Family ID: |
39493081 |
Appl. No.: |
11/952081 |
Filed: |
December 6, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60873549 |
Dec 6, 2006 |
|
|
|
Current U.S.
Class: |
606/305 ;
606/301 |
Current CPC
Class: |
A61B 17/70 20130101;
A61B 17/8883 20130101; A61B 17/861 20130101; A61B 17/8891 20130101;
A61B 17/86 20130101; A61B 2017/0647 20130101; A61B 17/0642
20130101; A61B 17/92 20130101; A61B 17/864 20130101; A61B 2017/0648
20130101; A61B 17/8875 20130101; A61B 17/8886 20130101; A61N 1/0558
20130101 |
Class at
Publication: |
606/305 ;
606/301 |
International
Class: |
A61B 17/56 20060101
A61B017/56 |
Claims
1. A hard tissue anchor for securing an element to a hard tissue
comprising: a penetrating end shaped for penetrating the hard
tissue; and a head having an aperture, wherein the aperture is
configured to receive the element therethrough and wherein the head
is configured to secure the element within the aperture.
2. A hard tissue anchor as in claim 1, wherein the element
comprises a lead.
3. A hard tissue anchor as in claim 1, wherein the head includes a
channel connected to the aperture, wherein the channel is
configured allow passage of the element from outside of the head to
the aperture.
4. A hard tissue anchor as in claim 3, wherein the head is
adjustable to close the channel.
5. A hard tissue anchor as in claim 4, wherein the head is
adjustable by deformation of the head.
6. A hard tissue anchor as in claim 5, wherein deformation of the
head secures the element within the aperture.
7. A hard tissue anchor as in claim 1, wherein the head further
comprises a grommet disposed within the aperture.
8. A hard tissue anchor as in claim 1, wherein the penetrating end
has a tapered, conical, notched, barbed or serrated shape.
9. A hard tissue anchor as in claim 1, wherein the penetrating end
has a shank with a helical thread.
10. A method for anchoring an element to a hard tissue in a body,
the method comprising: advancing a hard tissue anchor toward the
hard tissue, wherein the anchor has a penetrating end and a head
having an aperture; positioning the element within the aperture;
and applying pressure to the head so as to drive the penetrating
end at least partially into the hard tissue.
11. A method as in claim 10, wherein applying pressure comprises
applying pressure to the head so as to secure the element within
the aperture.
12. A method as in claim 11, wherein applying pressure comprises
deforming the head so as to secure the element within the aperture
due to friction.
13. A method as in claim 10, further comprising implanting the
element in the body.
14. A method as in claim 13, wherein the positioning step occurs
after the implanting step.
15. A method as in claim 10, wherein the anchor includes a channel
connected to the aperture and further comprising passing a portion
of the element through the channel to the aperture.
16. A method as in claim 15, wherein applying pressure comprises
deforming the head so as to at least partially close the
channel.
17. A method as in claim 10, further comprising mounting the head
of the anchor on a distal end of an applicator.
18. A method as in claim 17, wherein advancing the hard tissue
anchor toward the hard tissue comprises advancing the distal end of
the applicator through a percutaneous access opening.
19. A method as in claim 17, wherein applying pressure to the head
comprises applying pressure to the applicator.
20. A method as in claim 17, wherein applying pressure to the
applicator comprises deforming the head by force of the applicator
so as to secure the element within the aperture due to
friction.
21. An applicator for delivering a hard tissue anchor, the
applicator comprising: an elongate body having a proximal end and a
distal end, wherein the distal end is configured to receive a head
of the hard tissue anchor; and a handle attached to the proximal
end of the elongate body so that force applied to the handle is
translatable to the head of the hard tissue anchor.
22. An applicator as in claim 21, wherein the elongate body is
shaped for passage through a percutaneous access opening.
23. An applicator as in claim 21, further comprising a release
button for releasing the hard tissue anchor from the distal end of
the elongate body.
24. An applicator as in claim 21, wherein the distal end includes a
recess for receiving the head.
25. An applicator as in claim 21, wherein the force comprises
longitudinal force which is translatable to a downward force on the
head of the hard tissue anchor.
26. A hard tissue anchor as in claim 21, wherein force comprises
rotational force which is translatable to rotation of the head of
the hard tissue anchor.
27. A hard tissue anchor as in claim 21, wherein the distal end
comprises a rotatable member joinable with the head, wherein the
rotation force rotates the rotatable member.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application claims priority of provisional patent
application No. 60/873,549 (Attorney Docket No. 10088-708.101),
filed on Dec. 6, 2006, which is incorporated herein by reference
for all purposes.
STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED
RESEARCH AND DEVELOPMENT
[0002] NOT APPLICABLE
REFERENCE TO A "SEQUENCE LISTING," A TABLE, OR A COMPUTER PROGRAM
LISTING APPENDIX SUBMITTED ON A COMPACT DISK
[0003] NOT APPLICABLE
BACKGROUND OF THE INVENTION
[0004] A variety of implantable medical devices are used to treat
portions of the anatomy which reside near bones or bony structures
within the body of a patient. Such devices are typically anchored
in place by suturing portions of the device to surrounding soft
tissue. Often the device includes suture holes designed
specifically for this purpose at predetermined locations along the
device. Thus, the device may only be sutured at these locations,
limiting the areas and types of tissue available for suturing
thereto. Often, the location is far from the treatment site. Such
distance and instability of anchoring tissue can contribute to lead
migration and pull-out.
[0005] For example, conventional spinal cord stimulators (SCS) are
positioned along the spinal column to treat pain. A conventional
SCS system comprises an implantable lead and an implantable power
source or implantable pulse pulse generator IPG. Using fluoroscopy,
the lead is implanted into the epidural space of the spinal column
and positioned against the dura layer of the spinal cord. The lead
extends from the spinal column to the IPG which is remotely
implanted. Typically, the lead is sutured to soft tissue remote
from the point of entry into the epidural space. And, lead
migration and pull-out are common problems associated with SCS.
[0006] Therefore, it is desired to provide a more stable anchoring
system for implantable devices, such as leads. Such an anchoring
system should provide anchoring at desired locations rather than
merely at locations along the device which are predesigned for
anchoring. Such anchoring should also assist in resisting migration
and pull-out. At least some of these objectives will be met by the
present invention.
BRIEF SUMMARY OF THE INVENTION
[0007] The present invention provides devices, systems and methods
for anchoring medical devices to hard tissues, such as bones or
bony structures, particularly vertebrae. A variety of medical
devices are used to treat portions of the anatomy which reside near
bones or bony structures within the body of a patient. The devices
and systems of the present invention are suitable for use with many
of such medical devices and specialized devices used for particular
treatments. By anchoring these directly to the surrounding hard
tissue, the devices are anchored closer to the source of treatment.
This provides additional stability and reduces migration of the
device at the treatment site. Also, by attaching to hard tissue
rather than soft tissue, a stronger attachment is often able to be
made.
[0008] In a first aspect of the present invention, a hard tissue
anchor is provided for securing an element to a hard tissue. In
some embodiments, the hard tissue comprises a penetrating end
shaped for penetrating the hard tissue, and a head having an
aperture, wherein the aperture is configured to receive the element
therethrough and wherein the head is configured to secure the
element within the aperture. Typically, the element comprises a
lead, however catheters or other devices may be used.
[0009] In some embodiments, the head includes a channel connected
to the aperture, wherein the channel is configured allow passage of
the element from outside of the head to the aperture. In some
instances, the head is adjustable to close the channel, such as by
deformation of the head. Optionally, deformation of the head may
secure the element within the aperture. In some embodiments, the
head further comprises a grommet disposed within the aperture. The
grommet may assist in holding the element within the aperture.
[0010] In some embodiments, the penetrating end has a tapered,
conical, notched, barbed or serrated shape. In such instances, the
hard tissue anchor is considered a tack and is pressed into the
hard tissue. In other embodiments, the penetrating end has a shank
with a helical thread. In these instances, the hard tissue anchor
is considered a screw and is rotated into the hard tissue.
[0011] In a second aspect of the present invention, a method is
provided for anchoring an element to a hard tissue in a body: In
some embodiments, the method comprises advancing a hard tissue
anchor toward the hard tissue, wherein the anchor has a penetrating
end and a head having an aperture, positioning the element within
the aperture, and applying pressure to the head so as to drive the
penetrating end at least partially into the hard tissue.
[0012] In some embodiments, applying pressure comprises applying
pressure to the head so as to secure the element within the
aperture. Optionally, applying pressure comprises deforming the
head so as to secure the element within the aperture due to
friction.
[0013] In some instances, the method further comprises implanting
the element in the body. Such implanting may occur before the
positioning step of positioning the element within the aperture.
This allows the hard tissue anchors to be utilized with existing
implanted systems.
[0014] In still further embodiments, the anchor includes a channel
connected to the aperture and the method further comprises passing
a portion of the element through the channel to the aperture.
Optionally, applying pressure comprises deforming the head so as to
at least partially close the channel.
[0015] To deliver a hard tissue anchor of the present invention,
such methods may include mounting the head of the anchor on a
distal end of an applicator. In some situations, advancing the hard
tissue anchor toward the hard tissue comprises advancing the distal
end of the applicator through a percutaneous access opening. In
such instances, the applicator has a low profile suitable for such
percutaneous delivery.
[0016] In some embodiments, applying pressure to the head comprises
applying pressure to the applicator. Optionally, applying pressure
to the applicator may comprise deforming the head by force of the
applicator so as to secure the element within the aperture due to
friction.
[0017] In a third aspect of the present invention, an applicator is
provided for delivering a hard tissue anchor. In some embodiments,
the applicator comprises an elongate body having a proximal end and
a distal end, wherein the distal end is configured to receive a
head of the hard tissue anchor, and a handle attached to the
proximal end of the elongate body so that force applied to the
handle is translatable to the head of the hard tissue anchor.
Optionally, the elongate body may be shaped for passage through a
percutaneous access opening.
[0018] In some embodiments, the applicator further comprises a
release button for releasing the hard tissue anchor from the distal
end of the elongate body. The distal end may include a recess for
receiving the head, from which the hard tissue anchor is
releasable.
[0019] When the hard tissue anchor comprises a bone tack, the force
typically comprises longitudinal force which is translatable to a
downward force on the head of the hard tissue anchor. When the hard
tissue anchor comprises a bone screw, the force typically comprises
rotational force which is translatable to rotation of the head of
the hard tissue anchor. In such instances, the distal end may
comprise a rotatable member joinable with the head, wherein the
rotation force rotates the rotatable member.
[0020] Other objects and advantages of the present invention will
become apparent from the detailed description to follow, together
with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] FIG. 1 illustrates a hard tissue anchor of the present
invention used with a conventional SCS system.
[0022] FIG. 2 illustrates a hard tissue anchor of the present
invention used with a lead which is implanted near a DRG to provide
selective stimulation thereto.
[0023] FIG. 3 illustrates an embodiment of a bone tack of the
present invention.
[0024] FIG. 4 illustrates an embodiment of a bone tack having an
element threaded through its head prior to implantation of the
element.
[0025] FIG. 5 illustrates a side view of a tack having a channel
along the top of the head.
[0026] FIG. 6 illustrates a top view of such the tack of FIG.
5.
[0027] FIG. 7 illustrates passing an element through a channel in
the head of a bone tack.
[0028] FIG. 8 illustrates a lead surrounded by a silicone tube
positioned within arms of the head of a bone tack.
[0029] FIGS. 9A-9B illustrate an embodiment of a bone tack having a
grommet.
[0030] FIG. 10 illustrates a tack having a grommet wherein the
channel of the grommet has been closed by crimping of the head.
[0031] FIGS. 11A, 11B, 11C, 11D illustrate front, side, top and
bottom views, respectively, of one embodiment of a bone tack of the
present invention.
[0032] FIG. 12 illustrates an applicator for delivery of a bone
tack to a portion of a hard tissue.
[0033] FIG. 13 illustrates a distal end of the applicator having a
recess for receiving a head of a bone tack.
[0034] FIG. 14 illustrates a bone tack securely fixed to an
applicator during insertion via friction fit with a grommet.
[0035] FIGS. 15A, 15B, 15C, 15D, 15E illustrates various views
elongate body of an applicator having an insert positionable within
its distal end.
[0036] FIG. 16 illustrates an embodiment of a bone screw of the
present invention.
[0037] FIGS. 17A, 17B, 17C, 17D, 17E illustrate various view of an
embodiment of a bone screw.
[0038] FIGS. 18A-18B illustrate an applicator for delivery of a
bone screw to a portion of a hard tissue.
DETAILED DESCRIPTION OF THE INVENTION
[0039] The present invention provides devices, systems and methods
for anchoring medical devices to hard tissues, such as bones or
bony structures, particularly vertebrae. A variety of medical
devices are used to treat portions of the anatomy which reside near
bones or bony structures within the body of a patient. For example,
spinal cord stimulators (SCS) are positioned along the spinal
column to treat pain. FIG. 1 illustrates a conventional SCS system
comprising an implantable lead 100 and an implantable power source
or implantable pulse pulse generator IPG. Using fluoroscopy, the
lead 100 is implanted into the epidural space E of the spinal
column S and positioned against the dura layer of the spinal cord.
The lead 100 is implanted either through the skin via an epidural
needle (for percutaneous leads) or directly and surgically through
a mini laminotomy operation (for paddle leads). In either case, the
leads 100 extend from the spinal column S to the IPG which is
remotely implanted. Typically, the leads 100 are sutured to soft
tissue remote from the point of entry into the epidural space E.
Such suturing is often insufficient to adequately the implanted
lead 100, thus leading to migration or pull-out. FIG. 1 illustrates
a hard tissue anchor 600 of the present invention used in
conjunction with the conventional SCS system to anchor the
implantable lead 100. As shown, the anchor 600 can be used to
attach the lead 100 a hard tissue, such as a vertebrae V near the
point of entry to the epidural space E. This provides more secure
anchoring by fixing to a harder tissue and reduces the distance
between the distal portion of the lead and the site of anchoring.
This assists in reducing migration and pull-out of the lead
100.
[0040] In addition, the devices, systems and methods of the present
invention may be used to anchor other types of medical devices, in
particular various other types of leads used to selectively
stimulate the spinal anatomy, particularly the dorsal root or
dorsal root ganglion (DRG). FIG. 2 illustrates a lead 150 which is
implanted near a DRG to provide selective stimulation thereto.
Examples of such leads are provided in U.S. patent application Ser.
No. 11/952,049, filed Dec. 6, 2007, entitled "Grouped Leads For
Spinal Stimulation", (Attorney Docket No. 10088-706.201/Client Ref
No. SM-00610US) and U.S. patent application Ser. No. 11/952,053,
filed Dec. 6, 2007, entitled "Grouped Leads For Posterior Access Of
Directed Spinal Stimulation" (Attorney Docket No.
10088-707.201/Client Ref No. SM-00710US), both incorporated herein
by reference. As shown, a hard tissue anchor 600 of the present
invention may be used to anchor the lead 150 to a portion of the
vertebrae V which is near the DRG. This anchors the lead 150 close
to the stimulation site and reduces migration or pull-out of the
lead 150.
[0041] The hard tissue anchors 600 of the present invention include
bone tacks and bone screws. FIG. 3 illustrates an embodiment of a
bone tack 601 of the present invention. The bone tack 601 can be
used to anchor an element, such as a lead or catheter, to a bone or
bony structure, such as near to a site of an intended application.
In this embodiment, the bone tack 601 has a head 602 and a
penetrating end 604 opposite the head 602. The penetrating end 604
may have a tapered, conical, notched, barbed, serrated or otherwise
shaped end which is suitable for penetrating bone B, as shown. The
head 602 includes an aperture 607 through which the element 152 can
be threaded prior to implantation of the element 152, as
illustrated in FIG. 4. The bone tack 601 is advanced along the
element 152 to the desired anchoring position. Force is then
applied to the head 602 to advance the penetrating end 604 into the
bone B, thereby fixing the element 152 to the bone B at that
location. This may be achieved during the implantation procedure of
the element 150.
[0042] Other embodiments of the bone tack 601 are particularly
suited for anchoring the element 150 at an anchoring location when
it is less desirable to pre-load the anchor on the element 150.
This may be the case when the element 150 is already implanted or
it is not possible to advance an anchor over the element 150, such
as from one of the ends of the element 150 to the anchoring
location. In some of these embodiments, the head 602 of the bone
tack 601 includes a channel 608 which connects to the aperture 607.
FIG. 5 illustrates a side view of an embodiment of a tack 601
having such a channel 608 along the top of the head 602, and FIG. 6
illustrates a top view of such a tack 601. The tack 601 can be
slipped over the element 150 through the channel 608 in the head
602 so that the element 150 passes through the aperture 607, as
illustrated in FIG. 7. Thus, the tack 601 can be positioned at any
location along the element 150. The channel 608 can then be closed
by deformation of the head 602. Further deformation of the head 602
crimps the head 602 onto the element 150 resisting relative
motion.
[0043] FIG. 8 illustrates a lead 610 surrounded by a silicone tube
612 positioned within arms 614 of the head 602 of a bone tack 601.
Deforming or crimping of the head 602 (at least one arm 614) holds
the silicone tube 612 in relation to the head 602 and further
crimping holds the lead 610 in relation to the silicone tube 612.
Thus, various degrees of deformation may be used to provide
differing desired results.
[0044] In some embodiments, the tack 601 includes a grommet 606, as
illustrated in FIGS. 9A-9B. The grommet 606 includes a channel
which is alignable with the channel 608 of the head 602. Thus, an
element 150 may be passed through the channel 608 of the head 602
and the aligned channel of the grommet 606. The grommet 606 assists
in applying friction to the element 150 and protects the element
150 from possible damage. Deformation or crimping of the head 602
applies further friction to the element 150, such as fixing the
element 150 within the grommet 606. FIG. 10 illustrates a tack 601
having a grommet 606 wherein the channel of the grommet 606 has
been closed by crimping of the head 602. This illustrates the
reduction in size of the aperture an therefore increased friction
against the element 150.
[0045] FIGS. 11A, 11B, 11C, 11D provide front, side, top and bottom
views, respectively, of one embodiment of a bone tack 601 of the
present invention. In this embodiment, the tack 601 has a 0.060
inch diameter head 602 with a 0.040 inch diameter aperture 607.
Further, the head 602 has a 0.008 inch channel 608. This embodiment
also includes a penetrating end 604 having serrations which taper
from a first serration having a width of 0.045 inches to a second
serration having a width of 0.035 inches to a point. The
penetrating end 604 has a length of 0.105 inches from the center of
the aperture 607. Thus, the bone tacks 601 of the present invention
typically have a small size to allow positioning in confined or
hard to reach areas of the anatomy. It may be appreciated that such
dimensions are exemplary and are not intended to limit the scope of
the present invention.
[0046] The head 602 and a penetrating end 604 are typically formed
from the same material and may comprise any biocompatible and/or
bioresorbable material including but not limited to cobalt
chromium, cobalt chromium alloys, titanium, titanium alloys,
stainless steel, resorbable PGA or PLA, and PEEK.
[0047] The grommet 606 may be comprised of any soft biocompatible
and/or bioresorbable material including but not limited to silicone
or polyurethane. The grommet 606 could be an assembly or molded
onto the tack 606.
[0048] The bone tacks 601 of the present invention are driven into
a portion of bone B by mechanical force, such as tapping or
pressing. Referring to FIG. 12, an applicator 620 is provided for
delivery of the bone tack 601 to a portion of a bone B. The
applicator 620 is designed so that the tack 601 can be delivered
through a percutaneous access opening and positioned at an
anchoring location via fluoroscopy or other imaging techniques.
Typically, the applicator 620 comprises an elongate body 300 with a
low profile to assist in accessing a variety of target locations
within the body. The elongate body 300 has a proximal end 302 and a
distal end 304, wherein the distal end 304 is configured to receive
the hard tissue anchor 600. In most embodiments, the applicator 620
also includes a handle 306 attached to the proximal end 302 of the
elongate body 300.
[0049] FIG. 13 illustrates an embodiment of a distal end 304 of the
applicator 620 having a recess 624 for receiving a head 602 of a
bone tack 601. In some embodiments, the bone tack 601 is securely
fixed to the applicator 620 during insertion via friction fit with
the grommet 606, as illustrated in FIG. 14. The tack 601 is
penetrated and anchored into the bone B via the penetrating end
604, by application of downward or longitudinal force on the tack
601 by the applicator 620. Thus, force applied to the handle 306 is
translatable to the head 602 of the hard tissue anchor 600 and
drives the anchor 600 into the hard tissue. In some embodiments,
such force also then crimps the head 602 onto an element passing
through the aperture 607. The tack 601 can then be released from
the applicator 620, such as with the use of a release button 626.
The tack 601 is then left behind with the element passing
therethrough.
[0050] In some embodiments, the distal end 304 is comprised of an
insert that is inserted into the elongate body 300. FIGS. 15A-15E
illustrate various views of an elongate body 300 having an insert
301. Typically the insert 301 is formed or machined so that
together the insert 301 and the elongate body 300 desirably receive
the bone tack 601. FIG. 15A illustrates a side view of an insert
301 having a recess 624 for receiving a bone tack 601. Here the
recess 624 has a depth of 0.050 inches and a width of 0.060 inches.
FIG. 15B illustrates an embodiment of an elongate body 300 having a
length of 0.105 inches and a width of 0.28 inches. FIG. 15C
illustrates a bottom view of an insert 301 showing recess 624. The
insert 301 is inserted into a slot 303 in the elongate body 300,
illustrated in FIG. 15D. In this embodiment, the slot 303 has a
depth of 0.105 inches and a width of 0.028 inches. FIG. 15E
illustrates a side view of the elongate body 300 having a notch
305. When a bone tack 601 is inserted into the distal end 304, as
illustrated in FIG. 14, the aperture 607 of the bone tack 601 is
exposed to allow an element to pass therethrough. Referring back to
FIG. 15E, in this embodiment, the notch 305 has a width of 0.033
inches. It may be appreciated that the dimensions noted herein are
examples.
[0051] Example methods of installing a bone tack 601 of the present
invention are described herein. In one embodiment, a tack 601 of
the present invention is mounted in an applicator 620 as described
above. An element, such as a lead 610, is threaded through the
aperture 607 of the tack 601 while the tack 601 is held in the
applicator 620. The tack 601 is inserted into a percutaneous access
site, locating the target bone or bony structure via fluoroscopy or
other imaging method. The lead 610 is positioned as desired for its
intended therapeutic purpose. The bone tack 601 is then tapped into
place so that the penetrating end 604 sufficiently penetrates the
target bone or bony structure and the head crimps the lead. The
applicator 620 is then removed.
[0052] Thus, the bone tacks 601 of the present invention can be
used to secure various devices without the use of sutures. Further,
such securing or anchoring can be achieved in percutaneous
procedures without the need for a large surgical exposure. And,
such securing and anchoring is easily achievable without excessive
manipulation, particularly with the use of the deformable head
which secures the lead during insertion of the tack into bone.
Likewise, this action is assisted by the use of the applicator
which is able to hold the tack and deform the head while inserting
the tack into the bone.
[0053] FIG. 16 illustrates an embodiment of a bone screw 650 of the
present invention. The bone screw 650 can also be used to anchor an
element, such as a lead or catheter, to a bone or bony structure
near to a site of an intended application. The bone screw 650 has a
head 652 and a penetrating end 654 opposite the head 652.
Typically, the penetrating end 654 has a tapered shank with a
helical thread which is suitable for turning or twisting into bone.
In some embodiments, the thread is particularly suitable for
penetrating cortical bone. Cortical thread forms are generally
finer pitched (more threads per inch) and shallower than thread
forms designed to penetrate cancellous bone. In some embodiments,
the helical thread has a pitch of 0.020-0.200 inches, more
particularly 0.029 inches. Typically, the penetrating end 654 is
self-tapping and does not require the use of a bone tap to implant
the bone screw 650 into the hard tissue. In some embodiments, the
penetrating end 654 has an acute nose angle to assist in
self-tapping, such as a 60 degree nose angle. In some embodiments,
a wedge is added to further assist in self-tapping, such as a 30
degree wedge.
[0054] The head 602 includes an aperture 657 through which the
element 152 can be threaded prior to implantation of the element
152 in a manner similar to the bone tack 601 of FIG. 4. Or, the
screw 650 can be slipped over a portion of the element 152 through
a channel 658 in the head 652 which connects to the aperture 657 in
a manner similar to the bone tack 601 of FIG. 7. Optionally, the
bone screw 650 may include a grommet having similar features to the
grommet 606 described previously in relation to bone tacks 601.
[0055] FIGS. 17A-17E provide various views of one embodiment of a
bone screw 650 of the present invention. FIG. 17A illustrates a
perspective view of a bone screw 650 similar to the bone screw of
FIG. 16. However in this embodiment, the penetrating end 654 has a
thread which is more suitable for penetrating cancellous bone. FIG.
17B illustrates a side view of the bone screw 650 of FIG. 17A. In
this embodiment, the head 652 has a diameter of approximately 0.14
inches and an aperture 657 having a diameter of approximately 0.06
inches. Likewise, the head 652 has a 0.03 inch channel 658. The
penetrating end 654 has a length of 0.38 inches from the center of
the aperture 657 and a diameter of approximately 0.10 inches (as
illustrated in the top view of FIG. 17E). Referring to FIG. 17C and
its cross-section shown in FIG. 17D, the penetrating end 654 has a
shank with a helical thread with a pitch of 0.075 inches. Thus, the
bone screws 650 of the present invention typically have a small
size to allow positioning in confined or hard to reach areas of the
anatomy. It may be appreciated that such dimensions are exemplary
and are not intended to limit the scope of the present
invention.
[0056] The head 652 and a penetrating end 654 of the bone screws
650 are typically formed from the same material and may comprise
any biocompatible and/or bioresorbable material including but not
limited to cobalt chromium, cobalt chromium alloys, titanium,
titanium alloys, stainless steel, resorbable PGA or PLA, and
PEEK.
[0057] The bone screws 650 of the present invention are driven into
a hard tissue, such as a portion of bone B, by rotational force.
Referring to FIGS. 18A-18B an applicator 660 is provided for
delivery of the bone screw 650 to a portion of a bone B. The
applicator 660 is designed similarly to the bone tack applicator
620 in that it has a low profile so that the screw 650 can be
delivered through a percutaneous access opening and positioned at
an anchoring location via fluoroscopy or other imaging techniques.
Again, the applicator 660 typically comprises an elongate body 670
having a proximal end 672 and a distal end 662, wherein the distal
end 662 is configured to receive the hard tissue anchor 600. In
most embodiments, the applicator 660 also includes a handle
attached to the proximal end 672 of the elongate body 670.
[0058] FIG. 18A illustrates an embodiment of a distal end 662 of
the applicator 660 having a recess 664 for receiving a head 652 of
a bone screw 650. The applicator 660 includes a rotatable member
661 which is joinable with the bone screw 650. FIG. 18B illustrates
a bone screw 650 securely fixed to the rotatable member 661 via
friction, such as with a grommet. The screw 650 is penetrated and
anchored into the bone B via rotation of the penetrating end 604 by
rotating the member 661. When it is desired to deform or crimp the
head 652, force may be applied to the handle and translated to the
head 652 which crimps the head 652 onto an element passing through
the aperture 657. The screw 650 can then be released from the
applicator 660, such as with the use of a release button.
[0059] One challenge of a twisting or screw-type penetration is
that the orientation of the aperture 657 depends on how the screw
650 is screwed in. Also, placing the lead into the aperture 657
after delivery may be difficult due to its orientation. These
challenges are overcome by the bone screws 650 of the present
invention. The bone screw 650 may be screwed in place at a desired
location first and then the element, such as a lead, is loaded
through the channel 658 in the head 652. The lead is then advanced
to a desired position for the therapeutic application and secured
in place by crimping of the head 652.
[0060] Although the foregoing invention has been described in some
detail by way of illustration and example, for purposes of clarity
of understanding, it will be obvious that various alternatives,
modifications and equivalents may be used and the above description
should not be taken as limiting in scope of the invention.
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