U.S. patent application number 10/667159 was filed with the patent office on 2004-03-25 for bone anchor placement device with recessed anchor mount.
This patent application is currently assigned to Scimed Life Systems, Inc.. Invention is credited to Beaudet, Stephen P., Gellman, Barry N., Morin, Armand, Sater, Ghaleb A..
Application Number | 20040059341 10/667159 |
Document ID | / |
Family ID | 46257325 |
Filed Date | 2004-03-25 |
United States Patent
Application |
20040059341 |
Kind Code |
A1 |
Gellman, Barry N. ; et
al. |
March 25, 2004 |
Bone anchor placement device with recessed anchor mount
Abstract
A bone anchor placement device includes a handle and a shaft
extending in a distal direction from the handle. A head is disposed
at a distal end of the shaft and a retractable anchor driver is
disposed within the head. The recessed anchor mount is operable to
advance from the head during placement of an anchor in to a
supporting structure. The recessed anchor mount is operable to
retract into the head during insertion of the placement device
within a human body. The recessed anchor mount may include a push
wire for advancing and retracting the retractable anchor mount.
Inventors: |
Gellman, Barry N.; (North
Eastern, MA) ; Sater, Ghaleb A.; (Lynnfield, MA)
; Morin, Armand; (Berkley, MA) ; Beaudet, Stephen
P.; (Littleton, MA) |
Correspondence
Address: |
TESTA, HURWITZ & THIBEAULT, LLP
HIGH STREET TOWER
125 HIGH STREET
BOSTON
MA
02110
US
|
Assignee: |
Scimed Life Systems, Inc.
Maple Grove
MN
|
Family ID: |
46257325 |
Appl. No.: |
10/667159 |
Filed: |
September 19, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10667159 |
Sep 19, 2003 |
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09738378 |
Dec 15, 2000 |
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6660010 |
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09738378 |
Dec 15, 2000 |
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09309816 |
May 11, 1999 |
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6241736 |
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09738378 |
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09238654 |
Jan 26, 1999 |
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6264676 |
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60085113 |
May 12, 1998 |
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60125207 |
Mar 18, 1999 |
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60072641 |
Jan 27, 1998 |
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Current U.S.
Class: |
606/104 |
Current CPC
Class: |
A61B 2017/044 20130101;
B25B 17/00 20130101; A61B 17/8875 20130101; A61B 2017/0046
20130101; A61B 2017/0409 20130101; A61B 17/0493 20130101; A61B
2017/0454 20130101; A61B 2017/0479 20130101; A61B 17/0401 20130101;
A61B 17/861 20130101; A61B 2017/00805 20130101; B25B 13/481
20130101; A61B 2090/0801 20160201; A61B 17/0483 20130101; A61B
17/863 20130101 |
Class at
Publication: |
606/104 |
International
Class: |
A61B 017/58 |
Claims
What is claimed is:
1. A manual bone anchor placement device, comprising: a manually
actuatable lever; a resilient element; a force translator
comprising a distal end and a proximal end, the proximal end being
coupled to the lever and the distal end being coupled to the
resilient element, the force translator transmitting a force
exerted on the lever to the resilient element; and a rotator
coupled to the resilient element, the rotator receiving force from
the resilient element and rotating in response thereto.
2. The manual bone anchor placement device of claim 1, further
comprising a securing element coupled to the rotator, the securing
element mating with a bone anchor screw and rotating when the
rotator rotates, thereby applying a torque on the bone anchor screw
and placing the bone anchor screw into bone.
3. The manual bone anchor placement device of claim 2, wherein the
securing element comprises teeth and wherein the rotator comprises
at least one protruding portion capable of engaging the teeth.
4. The manual bone anchor placement device of claim 3, wherein the
at least one protruding portion comprises a pawl.
5. The manual bone anchor placement device of claim 1, further
comprising a handle including a groove for receiving a suture
attached to a bone anchor screw.
6. The manual bone anchor placement device of claim 1, further
comprising a connector with a first end and a second end, the first
end coupled to the force translator, and the second end coupled to
the lever.
7. The manual bone anchor placement device of claim 6, wherein the
lever comprises a slot for receiving the connector.
8. The manual bone anchor placement device of claim 6, wherein the
lever further comprises a pivot, the connector being positioned
below the pivot, and the force translator receiving a push force
when the lever is manually actuated.
9. A manual bone anchor placement device, comprising: a manually
actuatable lever; a force translator comprising a distal end and a
proximal end, the proximal end receiving force from the lever; a
rack coupled to the distal end of the force translator, receiving
force from the force translator, the rack moving linearly into an
engaging position in response to the force from the force
translator; a rotator positioned in close proximity to the rack,
engaging with the rack when the rack moves into the engaging
position and rotating in response to engagement by the rack.
10. The manual bone anchor placement device of claim 9, further
comprising a coupler coupled to the rotator for mating with a bone
anchor screw, and for rotating when the rotator rotates to place
the bone anchor screw into bone.
11. The manual bone anchor placement device of claim 9, further
comprising a handle including a groove for receiving a suture
attached to a bone anchor screw.
12. The manual bone anchor placement device of claim 9, wherein the
rotator is selected from the group consisting of a ratchet wheel, a
pawl, a pinion, and a gear.
13. The manual bone anchor placement device of claim 9, further
comprising a connector that connects the force translator to the
lever.
14. The manual bone anchor placement device of claim 9, wherein the
lever further comprises a pivot, the connector being positioned
below the pivot, the force translator receiving a push force when
the lever is manually actuated.
15. The manual bone anchor placement device of claim 9, wherein the
lever further comprises a pivot, the connector being positioned
above the pivot, the force translator receiving a pull force when
the lever is manually actuated.
16. The manual bone anchor placement device of claim 9, further
comprising a spring that encircles an end of the force translator
proximal to the rack.
17. The manual bone anchor placement device of claim 10, further
comprising a spring that encircles an end of the coupler proximal
to the rotator.
18. The manual bone anchor placement device of claim 9, wherein the
distal end of the force translator comprises a first wedge member,
and wherein the device further comprises a tubular member coupled
to the lever, the tubular member having a second wedge member
positioned in close proximity to the first wedge member for
transmitting force from the lever to the force translator through
the first wedge member.
19. The manual bone anchor placement device of claim 9, wherein the
force translator comprises a plunger for receiving pneumatic or
hydraulic force when the lever is actuated.
20. A manual bone anchor placement device, comprising: a manually
actuatable lever; a driver rod comprising threads; a cup coupled to
the lever, positioned over the threads of the driver rod, and
movable axially along the driver rod upon manual actuation of the
lever; and a washer positioned over the threads of the driver rod,
engaging the cup upon manual actuation of the lever, translating
force from the lever to the driver rod, and rotating the driver
rod.
21. The manual bone anchor placement device of claim 20, further
comprising a coupling element for mating with a bone anchor screw,
and for rotating when the driver rod rotates to place the bone
anchor screw into bone.
22. The manual bone anchor placement device of claim 20, further
comprising a force translating member coupled to the lever at a
pivot and coupled to the cup by flanges on the cup, for translating
force from the lever to the cup.
23. The manual bone anchor placement device of claim 20, further
comprising a handle including a groove for receiving a suture
attached to a bone anchor screw.
24. The manual bone anchor placement device of claim 20, wherein
the washer further comprises at least one engaging pin for engaging
the cup and the cup comprises holes for receiving the at least one
engaging pin.
25. The manual bone anchor placement device of claim 20, wherein
the cup further comprises at least one engaging pin for engaging
the washer and the washer comprises holes for receiving the at
least one engaging pin.
26. A buttress-shaped bone anchor screw comprising a micropolished
eyelet for receiving a suture.
27. The bone anchor screw of claim 26, wherein the eyelet is
circular, ellipsoidal, or teardrop shaped.
28. A protective cover for protecting a bone anchor screw
comprising a base for engaging with a bone anchor placement device,
a sheath coupled to the base for surrounding and protecting a bone
anchor screw, the sheath being collapsible for uncovering the bone
anchor screw when the bone anchor screw is placed into bone.
29. A kit comprising a flexible, molded sleeve for enclosing a
suture therein and at least one retaining clip for preventing the
suture from slipping out of the sleeve.
30. The kit of claim 29, wherein the sleeve further comprises a
Teflon.RTM. material.
31. The kit of claim 29, further comprising a buttress-shaped bone
anchor screw comprising a micropolished eyelet for receiving a
suture.
32. The kit of claim 31, wherein the buttress-shaped bone anchor
screw is pre-attached to a suture.
33. The manual bone anchor placement device of claim 1, 9, or 20,
further comprising: a head assembly; a recessed anchor mount
movably disposed within the head assembly; and an actuation
mechanism coupled to the recessed anchor mount.
34. The manual bone anchor placement device of claim 33, wherein
the actuation mechanism is selected from the group consisting of a
push wire and a pull wire.
35. The manual bone anchor placement device of claim 33, wherein
the actuation mechanism actuates the recessed anchor mount between
a recessed position and an advanced position.
36. The manual bone anchor placement device of claim 33, wherein
the anchor mount includes an outer surface comprising at least one
flat surface and the head assembly defines a core comprising a
mating shape.
37. The manual bone anchor placement device of claim 33 further
comprising a bone anchor releasably engaged to the anchor
mount.
38. The manual bone anchor placement device of claim 37, wherein
the anchor mount includes a groove for accommodating a suture
attached to the bone anchor.
39. A manual bone anchor placement device, comprising: a handle; a
shaft extending in a distal direction from the handle; a head
assembly disposed at a distal end of the shaft; a recessed anchor
mount movably disposed within the head assembly; and an actuation
mechanism coupled to the recessed anchor mount.
40. The manual bone anchor placement device of claim 39, wherein
the actuation mechanism is selected from the group consisting of a
push wire and a pull wire.
41. The manual bone anchor placement device of claim 39, wherein
the actuation mechanism actuates the recessed anchor mount between
a recessed position and an advanced position.
42. The manual bone anchor placement device of claim 39, wherein
the anchor mount includes an outer surface comprising at least one
flat surface and the head assembly defines a core comprising a
mating shape.
43. The manual bone anchor placement device of claim 39, wherein
the actuation mechanism is situated within a channel disposed on
the handle.
44. The manual bone anchor placement device of claim 39, wherein an
actuator operates the actuation mechanism disposed on the
handle.
45. The manual bone anchor placement device of claim 40, wherein
the actuation mechanism comprises a material selected from the
group consisting of spring steel and nitinol.
46. The manual bone anchor placement device of claim 39 further
comprising a bone anchor releasably engaged to the anchor
mount.
47. The manual bone anchor placement device of claim 39 further
including a stop disposed within the head assembly.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This is a continuation-in-part of U.S. patent application
Ser. No. 09/309,816, filed on May 11, 1999, which claims priority
to U.S. Provisional Patent Application Serial Nos. 60/085,113,
filed May 12, 1998, and 60/125,207, filed Mar. 18, 1999. This is
also a continuation-in-part of U.S. patent application Ser. No.
09/238,654, filed on Jan. 26, 1999, which claims priority to U.S.
Provisional Patent Application Serial No. 60/072,641, filed Jan.
27, 1998.
TECHNICAL FIELD
[0002] The invention relates generally to devices for placing bone
anchors in bone, and in particular, to recessed bone anchor mounts
used in connection with bone anchor drivers.
BACKGROUND INFORMATION
[0003] Urinary incontinence in women may be caused by urethral
hypermobility, a condition in which the bladder neck and proximal
urethra may rotate and descend in response to increases in
intra-abdominal pressure. Hypermobility may be the result of aging,
child delivery or conditions that weaken, stretch, or tear the
muscles around the bladder, bladder neck and/or urethra. Urinary
incontinence may also be caused by intrinsic sphincter deficiency
(ISD), a condition in which the urethral sphincter does not coapt
properly.
[0004] There are numerous approaches for treating urinary
incontinence. In a bladder neck suspension procedure for treating
hypermobility, sutures are placed around the muscle groups on
either side of the urethra and are affixed to the pubic bone or
other supporting structures to reposition and resuspend the
proximal urethra. Also common are sling type operations, which may
be performed to treat urethral hypermobility, intrinsic sphincter
deficiency or both. In a sling type operation, a sling is placed
under the urethra and bladder and is tensioned to elevate and
stabilize the urethra, prevent excessive downward mobility, or
compress the sphincter to treat intrinsic sphincter deficiency.
[0005] In these procedures, sutures are anchored to the supporting
structures, such as the pubic bone, Cooper's ligament, or the
rectus fascia. Bone anchor placement devices, such as bone anchor
drivers, may be used to place bone anchors at selected insertion
sites in the pubic bone. Sutures may then be attached to the bone
anchors.
[0006] To reduce postoperative patient discomfort, transvaginal
surgical procedures for bone anchor placement are preferred over
percutaneous procedures, which require an incision in the abdominal
wall (and sometimes the vaginal wall) to introduce a bone anchor
placement device, and can be highly invasive and traumatic to the
patient. In a transvaginal procedure, vaginal incisions are made
and bone anchors or similar attachment devices are secured to the
posterior side pelvic wall through the vaginal incision. While
being guided to the desired locations, the anchor placement device
passes through multiple layers of tissue. During this process, an
unprotected bone anchor can catch, tear or scrape tissue, snap a
surgeon's glove, or become dislodged.
[0007] It is desirable, therefore, to provide a protection
mechanism for the bone anchor that prevents the sharp tip of the
anchor from causing unintended tissue damage during passage of the
anchor through tissue. At the same time, it is desirable that the
head design for a bone anchor placement device be as compact as
possible to minimize the necessary size of the vaginal incision
through which the anchor placement device is inserted.
SUMMARY OF THE INVENTION
[0008] The present invention relates to manual bone anchor
placement devices. The manual bone anchor placement devices
disclosed herein are particularly useful in transvaginal methods of
treating female urinary incontinence, although they can be used in
other medical applications. The devices of the present invention
are designed to permit rotational insertion of a bone anchor screw
and to provide low cost alternatives to powered cannulated drills.
The devices may be disposable or may be modular in nature, thereby
allowing interchange of parts for reuse.
[0009] An advantage of the disclosed manual bone anchor placement
devices is that they eliminate the need for a percutaneous incision
to access an insertion area, although the devices can be used in a
percutaneous procedure. A transvaginal approach to inserting a bone
anchor screw into the pubic bone is far less invasive than a
percutaneous procedure, thus a transvaginal procedure is far less
traumatic for the patient.
[0010] An additional advantage of the disclosed manual bone anchor
placement devices is that they seat a self-tapping bone anchor
screw with a pre-attached suture. Since the bone anchor screw used
with the disclosed devices is self-tapping and the suture is
pre-attached, it is unnecessary for the physician to prebore a hole
into the bone, remove the drill, introduce a seating device, seat
the bone anchor screw, and then thread the suture. Single-step
insertion of the bone anchor screw and suture not only reduces the
total time required for the procedure, it also greatly reduces the
possibility that the physician may lose access to the bored hole or
seated bone anchor screw. Thus, the possible need to drill
additional holes and/or seat additional bone anchor screws is
reduced.
[0011] The manual bone anchor placement devices disclosed herein
provide a mechanism to translate linear force exerted by a user on
a lever into rotary force on a bone anchor screw. In one aspect of
the invention, the manual bone anchor placement device includes a
manually actuatable lever, a resilient element, a force translator,
and a rotator. The force translator is coupled at its proximal end
to the lever and at its distal end to the resilient element. The
resilient element is coupled to the rotator. Linear force on the
lever is transmitted through the force translator to the resilient
element and from the resilient element to the rotator. The rotator
rotates in response to this force. The device may further include a
securing element coupled to the rotator that mates with a bone
anchor screw and rotates when the rotator rotates, thereby applying
a torque on the bone anchor screw and placing the bone anchor screw
into bone.
[0012] In another aspect of the invention, the manual bone anchor
placement device includes a manually actuatable lever, a force
translator, a rack, and a rotator. The force translator includes a
distal end and a proximal end, the proximal end receiving force
from the lever, the distal end being coupled to the rack. The force
translator transmits force to the rack, which moves linearly into
an engaging position in response to this force. The rotator is
positioned in close proximity to the rack for engagement with the
rack when the rack moves into the engaging position. Engagement of
the rotator by the rack causes the rotator to rotate. The device
may further include a coupler coupled to the rotator that mates
with a bone anchor screw and rotates when the rotator rotates,
thereby placing the bone anchor screw into bone.
[0013] In another aspect of the invention, a manual bone anchor
placement device is disclosed that includes a manually actuatable
lever, a driver rod with threads, and a cup and washer positioned
over the threads. The cup is coupled to the lever and moves axially
along the driver rod upon actuation of the lever, engaging with the
washer. When the cup and washer engage each other, linear force
transmitted from the lever through the cup is translated to a
rotary force on the driver rod, rotating the driver rod. The device
may further include a coupling element for mating with a bone
anchor screw and for rotating when the driver rod rotates to place
the bone anchor screw into bone.
[0014] The present invention also relates to a self-tapping
buttress-shaped bone anchor screw. The bone anchor screw of the
present invention comprises a micropolished eyelet for receiving a
suture. The eyelet may be circular, ellipsoidal, or teardrop
shaped. The bone anchor screw described herein is designed to
require less torque to seat and to minimize load on a pre-attached
suture in comparison with known bone anchor screws.
[0015] Kits are also disclosed comprising any of: a molded flexible
sleeve for enclosing a suture, a retaining clip for preventing the
suture from slipping out of the sleeve, a buttress-shaped bone
anchor screw comprising a micropolished eyelet for receiving a
suture, and a suture which may, or may not, be pre-attached to the
bone anchor screw. A collapsible, protective cover for a bone
anchor screw is also disclosed.
[0016] In yet another aspect of the invention, the manual bone
anchor placement device includes a head assembly, a recessed anchor
mount movably disposed within the head assembly, and an actuation
mechanism coupled to the recessed anchor mount. In various
embodiments, the actuation mechanism can be a push wire or a pull
wire, and the mechanism actuates the recessed anchor mount between
a recessed position and an advanced position. The anchor mount can
include an outer surface having at least one flat surface and the
head assembly can have a core comprising a mating shape. Further,
the manual bone anchor placement device can include a bone anchor
releasably engaged to the anchor mount. In addition, the anchor
mount can include a groove for accommodating a suture attached to
the bone anchor.
[0017] In still another aspect of the invention, the manual bone
anchor placement device includes a handle, a shaft extending in a
distal direction from the handle, a head assembly disposed at a
distal end of the shaft, a recessed anchor mount movably disposed
within the head assembly, and an actuation mechanism coupled to the
recessed anchor mount. In various embodiments, the actuation
mechanism can be a push wire or a pull wire, and the mechanism
actuates the recessed anchor mount between a recessed position and
an advanced position. Further, the actuation mechanism can be
situated within a channel disposed on the handle, an actuator
disposed on the handle can operate the actuation mechanism, and the
actuation mechanism may be manufactured of spring steel or nitinol.
The anchor mount can include an outer surface having at least one
flat surface and the head assembly can have a core comprising a
mating shape. Further, the manual bone anchor placement device can
include a bone anchor releasably engaged to the anchor mount. In
addition, the anchor mount can include a groove for accommodating a
suture attached to the bone anchor. Still further, the manual bone
anchor placement device can include a stop disposed within the head
assembly, for example within the core. Alternatively, the stop can
be located on the actuation mechanism.
[0018] These and other objects, along with advantages and features
of the present invention herein disclosed, will become apparent
through reference to the following description of embodiments of
the invention, the accompanying drawings, and the claims.
Furthermore, it is to be understood that the features of the
various embodiments described herein are not mutually exclusive and
can exist in various combinations and permutations.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] In the drawings, like reference characters generally refer
to the same parts throughout the different views. Also, the
drawings are not necessarily to scale, emphasis generally being
placed upon illustrating the principles of the invention.
[0020] FIG. 1A is a perspective side view of a manual bone anchor
placement device within the scope of the present invention. FIG. 1B
shows a section of a side-view of the shaft of a manual anchor
placement device to which a suture ring is clipped and through
which a suture is threaded. FIG. 1C shows an enlarged
cross-sectional view of a suture ring.
[0021] FIG. 2 shows a perspective side view of a manual bone anchor
placement device according to one embodiment of the present
invention. In this embodiment, the manual bone anchor placement
device comprises a groove cut into the outer surface of the handle
through which a suture is threaded and the shaft of the manual bone
anchor placement is angled upwards at about a 90-degree angle.
[0022] FIG. 3A is a side view of a cross-section through a
wrap-around manual bone anchor screw placement device according to
one embodiment of the invention showing the components of an action
mechanism and a wrap-around rotary force mechanism in which a
resilient element is wrapped around a rotator. FIG. 3B is an
enlarged perspective view of a connector and lever arrangement in
an action mechanism according to one embodiment of the
invention.
[0023] FIGS. 4A-4D show views of the head end of a wrap-around
manual bone anchor placement device according to different
embodiments of the invention. FIG. 4A shows a cross-sectional view
of an embodiment where the rotator includes a floating pawl. FIG.
4B shows an enlarged cross-sectional view of a rotator that has
three floating pawls. FIG. 4C shows a three-dimensional cut-away
view of the head end of the shaft in an embodiment of the invention
where the rotator has two floating pawls. FIG. 4D shows a
three-dimensional cut-away view of the head end of the shaft in an
embodiment of the invention where the rotator has a single floating
pawl.
[0024] FIGS. 5A-5H show enlarged views of securing elements used
with a wrap-around manual bone anchor placement device and bone
anchor screws according to different embodiments of the invention.
FIGS. 5A-5D show enlarged views of a securing element that has a
hex-shaped recess in its mating portion for mating with a bone
anchor screw with a hex-shaped shaft at its base. FIG. 5A is a
perspective view of the securing element showing the hex-shaped
recess. FIG. 5B is a cross-sectional view through the engaging
portion of the securing element. FIG. 5C is a perspective side-view
of the securing element. FIG. 5D is a view from the top of the
securing element. FIG. 5E shows a bone anchor screw that has a
hex-shaped shaft at its base. FIG. 5F shows a perspective view of a
securing element whose mating portion has a hex-shaped protrusion.
FIG. 5G shows a perspective side view of a securing element whose
mating portion has a hex-shaped protrusion. FIG. 5H shows an
enlarged view of a bone anchor screw with a hex-shaped recess at
its base for mating with a securing element whose mating portion
has a hex-shaped protrusion.
[0025] FIGS. 6A-6C show enlarged views of the rotatable housing
used in a wrap-around manual bone anchor placement device. FIG. 6A
shows a perspective view. FIG. 6B shows a side view. FIG. 6C shows
a cross-sectional view.
[0026] FIGS. 7A-7C show enlarged views of the floating portion of a
floating pawl used in a wrap-around manual bone anchor placement
device. FIG. 7A shows a perspective view. FIG. 7B shows a side
view. FIG. 7C shows a cross-sectional view.
[0027] FIGS. 8A-8C show enlarged views of the flat spring portion
of a floating pawl used in a wrap-around manual bone anchor
placement device. FIG. 8A shows a perspective view where the flat
spring portion is slightly bent. FIG. 8B shows a side view of a
flat spring portion that is slightly bent. FIG. 8C shows a
perspective view where the flat spring portion is lying flat.
[0028] FIG. 9 shows an enlarged view of a resilient element used in
a wrap-around manual bone anchor screw placement device.
[0029] FIG. 10 shows a schematic view of how force is transmitted
through the resilient element in a wrap-around manual bone anchor
placement device.
[0030] FIG. 11 shows a perspective view of a wrap-around manual
anchor placement device according to one embodiment of the
invention where the shaft and handle portions include
interchangeable modules.
[0031] FIGS. 12A-12I show enlarged views of a head module of a
wrap-around manual bone anchor placement device according to one
embodiment of the invention.
[0032] FIG. 13A shows an enlarged perspective view of a head module
of a wrap-around manual bone anchor placement device according to
one embodiment of the invention where a protective sheath is
provided to protect the bone anchor screw and the portion of the
securing element that protrudes from the head module. FIG. 13B
shows an enlarged perspective view of a collapsible protective
cover for a bone anchor screw. The left-hand side of the Figure
shows the cover in an uncollapsed state. The right-hand side of the
Figure shows the cover in a collapsed state. FIG. 13C shows an
enlarged cross-sectional view of a collapsible protective cover
surrounding a bone anchor screw. The left-hand side of the Figure
shows the cover in an uncollapsed state and completely surrounding
a bone anchor screw. The right-hand side of the Figure shows the
cover in a collapsed state, exposing the bone anchor screw.
[0033] FIG. 14 shows an enlarged version of a securing element used
in a wrap-around manual bone anchor placement device according to
one embodiment of the invention where the mating portion of the
securing element may be uncoupled from the engaging portion of the
securing element.
[0034] FIG. 15 is a side view of a cross-section through a rack and
rotator manual bone anchor placement device according to one
embodiment of the invention, showing the components of an action
mechanism and a rack and rotator rotary force mechanism.
[0035] FIG. 16 shows an enlarged view of a head assembly in a rack
and rotator manual bone anchor screw placement device in which the
rotator comprises a ratchet wheel.
[0036] FIG. 17 shows an enlarged view of a head assembly in a rack
and rotator manual bone anchor placement device in which the
rotator comprises a pinion.
[0037] FIGS. 18A and 18B show a side view of a cross-section
through the handle and proximal portion of the shaft in a rack and
rotator manual bone anchor placement device according to one
embodiment of the invention. FIG. 18A shows an action mechanism
that transmits a pull force on a force translator. FIG. 18B shows
an action mechanism that transmits a push force on a force
translator.
[0038] FIG. 19 shows an enlarged cross-sectional view of a head
assembly in a rack and rotator manual bone anchor placement device
according to one embodiment of the invention, in which linear force
is transmitted to the rack through a rack spring and the rotator
comprises a pinion. A bone anchor screw with a pre-attached suture
is shown coupled to the pinion by a coupler. A protective cover
covers the bone anchor screw. Dashed lines in the Figure show the
portion of the bone anchor screw and pre-attached suture inside the
coupler.
[0039] FIG. 20 shows an enlarged cross-sectional view of a head
assembly in a rack and rotator manual bone anchor placement device
according to one embodiment of the invention in which linear force
is transmitted to the rack via wedge members.
[0040] FIG. 21 shows an enlarged cross-sectional view of a head
assembly in a rack and rotator manual bone anchor placement device
according to one embodiment of the invention in which linear force
is transmitted to the rack by pneumatic or hydraulic force on a
plunger.
[0041] FIG. 22A shows a cross-sectional sideview of a cup and
washer manual bone anchor placement device according to one
embodiment of the invention that includes a cup and washer rotary
force mechanism. FIG. 22B shows a further embodiment of the
invention in which a return coil spring is provided between the cup
and washer assembly and the barrel end of the handle.
[0042] FIGS. 23A-23D show enlarged views of a cup and washer
assembly used in a cup and washer manual bone anchor placement
device according to one embodiment of the invention. FIG. 23A shows
a cross-sectional view of a driver rod with grooves to interface
with protrusions on a washer. FIG. 23B shows a cross-sectional view
of a washer with corresponding protrusions to interface with the
grooves in the driver rod. FIG. 23C shows a perspective side view
of a cup and washer assembly on a driver rod in which the washer is
in a "free-floating" or non-engaged position. FIG. 23D shows a
perspective sideview of a cup and washer assembly in which the
washer is in an engaged position.
[0043] FIGS. 24A and 24B show enlarged views of a cup and washer
assembly according to one aspect of the invention. FIG. 24A shows a
cross-sectional view from one side of a cup and washer assembly
positioned on a driver rod that includes a cover plate. FIG. 24B
shows a cross-sectional view from the top of the cup and washer
assembly.
[0044] FIG. 25A shows a section of a lead anchor screw and a
coupling element used in a cup and washer manual bone anchor
placement device according to one embodiment of the invention in
which the coupling element has a recess through which the suture of
a bone anchor screw is threaded. The Figure shows the suture partly
pulled out of the recess. FIG. 25B shows a perspective view of the
top of a cover plate used in a cup and washer assembly according to
one embodiment of the invention. FIG. 25C shows a perspective view
of the top of a washer used in a cup and washer assembly. FIG. 25D
shows a perspective view of the top of a cup used in the cup and
washer assembly (i.e., the side that faces the washer).
[0045] FIG. 26 shows a cross-section through a longitudinal axis of
a self-tapping bone anchor screw according to one embodiment of the
invention.
[0046] FIG. 27A is a side view of an alternate embodiment of an
anchor placement device constructed according to the present
invention.
[0047] FIGS. 27B-27E are cross-sectional views of various
embodiments of the shaft of the device of FIG. 27A as taken at
A-A.
[0048] FIG. 28A is an enlarged perspective view of one embodiment
of an anchor mount constructed according to the present invention
and of a bone anchor for attachment to the anchor mount.
[0049] FIGS. 28B and 28C are end views of alternate embodiments of
an anchor mount constructed according to the present invention.
[0050] FIG. 29A is an enlarged view of one embodiment of the head
assembly of the anchor placement device of FIG. 27A, and of a
recessed anchor mount in a recessed position within the head
assembly.
[0051] FIG. 29B is an enlarged view of one embodiment of the head
assembly of the anchor placement device of FIG. 27A, and of a
recessed anchor mount in an advanced position protruding from the
head assembly.
[0052] FIG. 29C is an enlarged view of a push wire in point contact
with the anchor mount of FIG. 29A
[0053] FIG. 29D is an enlarged view of a push wire secured to the
anchor mount of FIG. 29A.
[0054] FIG. 30A is a side view of an alternate embodiment of the
anchor placement device depicted in FIG. 27A.
[0055] FIG. 30B is an enlarged view of one embodiment of the head
assembly of the anchor placement device of FIG. 30A, and of a
recessed anchor mount in a recessed position within the head
assembly.
DETAILED DESCRIPTION
[0056] The manual bone anchor placement devices disclosed provide a
mechanism to translate manual linear force (i.e., an operator's
hand squeezing a lever) into rotary force on a bone anchor screw.
As used herein "placing a bone anchor screw" (or grammatical
equivalents thereof) refers to rotational action on, and/or
screwing in, of a bone anchor screw into bone. Manual actuation of
the disclosed devices occurs when the operator squeezes or pulls a
lever with, for example, a single hand. Force on the lever is
mechanically transmitted through a force translator to a rotary
force mechanism. Each of the disclosed devices is distinguishable
by the type of rotary force mechanism used.
[0057] In one aspect of the invention, a manual bone anchor
placement device uses a rotary force mechanism that includes a
resilient element wrapped around a rotator ("wrap-around manual
bone anchor placement device"). In a second aspect of the
invention, a manual bone anchor placement device ("rack and rotator
manual bone anchor placement device") uses a rotary force mechanism
that includes a rack and rotator assembly. In a third aspect of the
invention, a manual bone anchor placement device uses a rotary
force mechanism that includes a cup and washer assembly ("cup and
washer manual bone anchor placement device"). A self-tapping bone
anchor screw with a pre-attached suture is also disclosed, which
may also be used with any of the aforementioned manual bone anchor
placement devices. In addition, a recessed bone anchor mount is
disclosed, which may be used with any of the aforementioned manual
bone anchor placement devices. All of the devices are useful in,
for example, transvaginal bone anchor screw insertion
procedures.
[0058] Wrap-Around Manual Bone Anchor Placement Device
[0059] In the embodiment of the invention shown in FIG. 1, the
manual bone anchor placement device 1 is substantially pistol- or
gun-shaped. In this embodiment, the manual bone placement device 1
includes a handle 2 and a shaft 3. The handle 2 has a gripping
portion 26 to facilitate gripping by the user and a lever 4 through
which the user may manually transmit force to the bone anchor
placement device 1.
[0060] As shown in FIG. 3A, the shaft 3 has a first end 3a,
proximal to the handle 2, and a second end or head end 3h, distal
to the handle 2. A force translator 12 runs through the shaft 2 and
transmits linear force exerted manually on the lever 4 to a head
assembly 35 positioned at the second end 3h of the shaft 3 (shown
enlarged in FIG. 4A). The head assembly 35 is capable of engaging
with a bone anchor screw 5 and includes the mechanism that
translates linear force from the force translator 12 to rotary
force on the bone anchor screw 5.
[0061] The shaft 3 is curved to facilitate correct placement of the
bone anchor placement device 1 to the proper bone anchor screw
insertion site. The shaft 3 is generally linear at its proximal or
first end 3a and angles upward near its head end 3h. The upward
angle can be from about 0 degrees to about 135 degrees. In one
embodiment of the invention, the upward angle is between about 75
degrees and about 100 degrees. In another embodiment of the
invention, shown in FIG. 2, the upward angle is approximately 90
degrees. In some embodiments of the invention, the shaft 3 can be
rotated about 360 degrees relative to the handle 2 (see dashed
arrow in FIG. 1A).
[0062] As shown in FIG. 3A, the handle 2 of the manual bone anchor
placement device 1 of the present invention may further include an
action mechanism through which force from the lever 4 is
transmitted to the force translator 12. The action mechanism
includes the lever 4, a pivot 9, and the proximal end of the force
translator 12. The force translator 12 is connected to the lever 4
by a connector 11 that is positioned beneath the pivot 9. The
action mechanism further includes a torsional spring 10 that abuts
the lever 4 in the handle 2.
[0063] In an embodiment of the invention shown in FIG. 3B, the
connector 11 has a "slot and pin arrangement." In this embodiment,
a slot us is included in the portion of the lever 4 proximal to the
pivot 9 and defines openings in the sides, front, and back of the
lever 4. A connector member 11m is configured to fit in the slot
11s and includes a pinhole 11h. The connector member 11m is coupled
to the force translator 12 at the end of the connector member 11m
distal to the pinhole 11h. The connector member is positioned
within the slot 11s and secured by a pin 11p that extends through
both the slot 11s and the pinhole 11h.
[0064] In the embodiment of the invention shown in FIG. 3A, the
lever 4 extends at least partially from the handle 2 and linear
force on the lever 4 is exerted by pulling on the lever 4. Because
the pivot 9 is located above the connector 11, the translator 12 is
subjected to tensile loading (e.g., a pulling force) during
activation and compressive loading (e.g., a pushing force) during
release. The torsional spring 10 abutting the lever 4 thus forces
the lever 4 into its original position for the next stroke.
[0065] Force exerted on the lever 4 is translated as linear force
through the force translator 12. As shown in FIG. 3A, the force
translator 12 is a substantially linear member that extends from
the handle 2 through the shaft 3 of the manual bone anchor device
1. The force translator 12 may be rigid or flexible, so long as it
is tensile. In one embodiment of the invention, the force
translator 12 is a wire. Additional types of force translators 12
include, but are not limited to, a cable, a rod, suture material, a
string, and the like. Suitable force translator 12 materials
include metal, plastic, polymers (e.g., nylon, in the case of
suture materials), copolymers, and the like.
[0066] In a further embodiment of the invention, washers 21 are
positioned on the inside of the shaft 3 to reduce the friction
caused by the force translator 12 contacting the inside surfaces of
the shaft 3 (see FIG. 4A). The washers 21 can be made of
Teflon.RTM. material or any material with a low coefficient of
friction.
[0067] The section of the shaft portion that seats the head
assembly 35 may be simply a wider extension of the head end 3h of
the shaft 3 shown in FIG. 3A. Alternatively, the head assembly 35
may be provided within a head module 28 seated on the distal-most
tip 3b of the shaft (as in FIGS. 4A, 4C, and 4D, for example) and
may be either integral with the shaft 3 or separable from the shaft
3. The head assembly 35 includes a rotator 14, a securing element
166, and a resilient element 13, shown in more detail in FIGS.
4A-4D. The resilient element 13 is coupled to both force translator
12 and the rotator 14. In one embodiment of the invention, as shown
in FIGS. 4C and 4D, the resilient element 13 is a constant force
spring that is welded to the end of the force translator 12 that is
proximal to the rotator 14.
[0068] Force is transmitted through the resilient element 13 to the
rotator 14, which rotates in response to this force. The rotator 14
has at least one protruding portion 15p, shown in more detail in
FIGS. 4C and 4D, and is capable of frictionally and mechanically
engaging with the securing element 166 (shown in more detail in
FIGS. 5A, 5C, 5F, and 5G). The securing element 166 further
includes an engaging portion 16 and a mating portion 6. The mating
portion 6 of the securing element 166 extends at least partly from
the head end 3h of the shaft 3, or the head module 28, and mates
with a bone anchor screw 5.
[0069] In the embodiment of the invention shown in FIGS. 4A-4C, the
rotator 14 has at least one floating pawl and the engaging portion
16 of securing element 166 has teeth 17 that are capable of meshing
with the protruding portion 15p of the floating pawl and rotating
in response to the rotation of the pawl. The protruding portion 15p
extends from a flat spring member 15s as shown in FIGS. 4C and 4D.
The flat spring member 15s may be angled or bent, as shown in more
detail in FIGS. 8A-8C, to control the position of the protruding
portion 15p of the pawl.
[0070] It will be readily apparent to one of ordinary skill in the
art that any number and type of protruding portions 15p may be
provided so long as they are able to frictionally and mechanically
engage with the engaging portion 16 of the securing element 166 to
cause rotation of the securing element 166. In the embodiment of
the invention shown in FIG. 4B, the rotator 14 includes three
floating pawls that are spaced equidistant from each other about a
central axis of rotation. In another embodiment of the invention,
shown in FIG. 4C, the rotator 14 includes two floating pawls, and
the teeth 17 of the engaging portion 16 are designed to allow
one-directional engagement with the pawls. Slip-free rotation of a
bone anchor screw 5 is provided by this design.
[0071] In the embodiment of the invention shown in FIGS. 4C and 4D,
the rotator 14 is contained within a rotatable housing 18
positioned within the head module 28 and is fitted into at least
one groove 22 within the inner wall of the rotatable housing 18.
FIGS. 6A-6C show enlarged views of the rotatable housing 18. In the
embodiment of the invention shown in FIGS. 6A and 6C, the rotatable
housing 18 has two grooves 22 to accommodate a rotator 14 that
includes two floating pawls.
[0072] In the embodiment of the invention shown in FIGS. 4A-4D, the
resilient element 13 is at least partially wound around the
rotatable housing 18, and the rotatable housing 18 and the rotator
14 move as one. The resilient element 13 is secured to the
rotatable housing 18 by the insertion of an inwardly projecting
tail 13t of the resilient element 13 into a notch 25 in the
rotatable housing 18. An enlarged view of the resilient element 13
and inwardly projecting tail 13t is shown in FIG. 9.
[0073] As shown schematically in FIG. 10, force transmitted through
the resilient element 13 causes the inner diameter ID of the
resilient element 13, which is wrapped around the rotatable housing
18, to decrease and the resilient element 13 to grip the rotatable
housing 18, resulting in its rotation. Upon elimination of force on
the resilient element 13, the inner diameter ID of the portion of
the resilient element 13 wrapped around the rotatable housing 18
gets larger, resulting in free rotation in the opposite direction.
The gripping action in one direction and the slipping action in the
opposite direction provide the action needed to drive a bone anchor
screw 5 into the bone when a linear pull force is exerted on the
lever 4.
[0074] In the embodiment of the invention shown in FIGS. 4C and 4D,
the securing element 166 is positioned at least partially within
the rotatable housing 18, and the engaging portion 16 of the
securing element 166 rotates in response to the rotation of the
rotatable housing 18 and rotator 14.
[0075] As shown in the enlarged view of the securing element 166
provided in FIGS. 5A and 5C, the securing element 166 further
includes a generally cylindrical front piece 19 that extends from
the engaging portion 16 of the securing element and fits into a
complementary recessed portion 30 in the inner wall of the head end
3h of the shaft 3 or the head module 28 (shown in FIGS. 12A, 12B,
and 12C). The front piece 19 acts to position the rotatable housing
18 within the head end 3h of the shaft 3 or within the head module
28 (as shown in FIGS. 12A, 12B, and 12C), allowing it to rotate
freely about the axis defined by the front piece 19.
[0076] The mating portion 6 of the securing element 166 extends at
least partially outside the head end 3h of the shaft 3. The bone
anchor screw 5 may be seated on the mating portion 6 of the
securing element 166 in a variety of ways and the mating portion 6
of the securing element 166 may be fabricated to complement a
variety of different types of bone anchor screws 5. In one
embodiment of the invention, shown in FIG. 5E, when the bone anchor
screw 5 being used provides a shaft 5a with a hex-shape, the mating
portion 6 of the securing element 166 is designed to provide a
recess 6a that has a hex-shaped cross-section (see FIGS. 5A, 5B,
and 5D). It will be readily apparent to one of ordinary skill in
the art that the recess 6a of the mating portion 6 of the securing
element 166 may be any type of shape (e.g., a T-shape or an
X-shape) that allows for frictional and mechanical engagement with
a bone anchor screw 5 having a shaft 5a with the corresponding
shape. In a further embodiment of the invention, shown in FIGS. 5F
and 5G, the mating portion 6 of the securing element 166 has a
shaft 6b while the bone anchor screw 5 (shown in FIG. 5H) provides
a recess 5b complementary to the shape of the shaft 6b
[0077] Any type of bone anchor screw 5 may be used adaptable to the
mating portion 6 of a selected securing element 166. In one
embodiment, shown in FIG. 1A, the bone anchor screw 5 has a
pre-attached suture 7 and the walls of the shaft 3 defining the
head end 3h of the shaft have aligned openings 20a and 20b through
which the suture 7 is threaded. (Aligned openings may also be
provided in the head module 28 in embodiments of the invention
where the bone anchor placement device comprises a head module 28.)
Attachment of the suture 7 along the length of the shaft 3 will
keep the suture 7 from becoming entangled during the bone anchor
screw insertion procedure.
[0078] In the embodiment of the invention shown in FIGS. 1A-1C, the
length of the suture 7 extending out of the head end 3h of the
shaft 3 may be secured by one or more suture rings 8 mounted on the
shaft 3. The suture rings 8 may be an integral part of the shaft 3
or may be clipped on as shown in FIG. 1B. After the bone anchor
screw 5 is seated, the bone anchor screw 5 disengages from the
mating portion 6 of the securing element 166. The suture 7 then
slips through aligned openings 20a and 20b at the head end 3h of
the shaft 3 and through the suture rings 8, disengaging from the
bone anchor placement device 1.
[0079] In another embodiment of the invention, shown in FIG. 2, a
groove 23 is cut into the outer surface of the handle 2, extending
in a line parallel to the longitudinal axis of the shaft 3, which
is proximal to the gripping portion 26 of the handle 2. In this
embodiment of the invention, the suture 7 is enclosed within a
flexible, molded sleeve 24, composed of Teflon.RTM. material, for
example, which is press-fitted into the groove 23 of the handle 2.
In a further embodiment of the invention, a retaining clip 27 may
be provided at the end of the sleeve 24 proximal to the gripping
portion 26 of the handle 2 to prevent the suture 7 from slipping
out before the bone anchor screw 5 is screwed into the bone. The
user of the manual bone anchor placement device 1 may then cut the
retaining clip 27, which allows the suture 7 to slide out of sleeve
24 after the bone anchor 5 is screwed into the bone.
[0080] In further embodiments of the invention, the manual bone
anchor placement device 1 may be fabricated from modules including
a handle module and a shaft module, allowing the user to mix and
match different handles 2 with different shafts 3 (including
different head assemblies 35). In the embodiment of the invention
shown in FIG. 11, the handle module comprises the two halves 2a and
2b of the handle 2 (including the two halves 26a and 26b of the
gripping portion 26) that are separable from each other. In this
embodiment, an old shaft 3o may be removed from the handle 2 upon
disconnecting the force translator 12 from the connector 11. A new
shaft 3nu may then be positioned within the handle 2. After
connecting the force translator 12 of the new shaft 3nu to the
connector 11, the two halves 2a and 2b of the handle 2 are snapped
back together and the wrap-around manual bone anchor placement
device 1 is ready for use.
[0081] In the embodiment shown in FIG. 11, interchanging the old
shaft 3o from the original bone anchor placement device 1 with a
new shaft 3nu provides the user with the opportunity to replace a
shaft 3 with an approximately 30 degree upward angle with one with
an approximately 90 degree upward angle and a different type of
head end 3h. The modular nature of the wrap-around bone anchor
placement device 1 thus allows users to select the type of shaft 3
or head end 3h/head module 28/head assembly 35 that best suits
their needs and facilitates repairs of the device 1.
[0082] As shown in FIGS. 12A-12I, the front half 28f and back half
28b of the head module 28 may also be separated by unscrewing
screws at coupling regions 33. This allows the user to vary the
exact configuration of the head module 28 and head assembly 35
being used with a particular shaft 3.
[0083] In the embodiment shown in FIGS. 12E, 12G, and 12H, the
front half of the head module 28f may also be provided with a
protruding threaded element 31. As shown in FIG. 13A, a protective
cover 32 may be seated on this threaded element 31, providing a
covering for the bone anchor screw 5 extending outside of the head
module through opening 36 and protecting the tip of the bone anchor
screw 5 from damage before it contacts a bone insertion site. In a
further embodiment of the invention, shown in FIGS. 13B and 13C,
the protective cover for protecting a bone anchor screw has a base
32b for engaging the shaft 3 of the manual bone anchor placement
device 1, and a sheath 32s coupled to the base 32b for surrounding
and protecting the bone anchor screw 5. The sheath 32s is
collapsible and collapses as the bone anchor screw 5 is driven into
bone, thereby uncovering the bone anchor screw 5. Sheath 32s
materials include flexible plastic, rubber, thin pleated metal, and
the like.
[0084] In still a further embodiment of the invention, shown in
FIG. 14, the mating portion 6 of the securing element 166 may be
uncoupled from the engaging portion 16 of the securing element 166
without opening the head end 3h or head module 28. In this
embodiment of the invention, the mating portion 6 of the securing
element 166 is threaded onto a threaded element 34 that protrudes
from the engaging portion 16 of the securing element 166 and may be
unscrewed from the engaging portion 16 of the securing element 166.
This embodiment of the invention allows different types of mating
portions 6 to be coupled to the engaging portion 16 of the securing
element 166 and thus allows the user to select a mating portion 6
of a securing element 166 that is complementary to any desired type
of bone anchor screw 5.
[0085] Rack and Rotator Manual Bone Anchor Placement Device
[0086] As shown in FIG. 15, the rack and rotator manual bone anchor
placement device 36, like the wrap-around device 1, is
substantially pistol- or gun-shaped and includes a handle 2 and a
shaft 3. The handle 2 includes a gripping portion 26 and a lever 4
through which a user may manually transmit linear force to the
rotary force mechanism of the device 36. Like the wrap-around
device 1, the shaft 3 of the rack and rotator manual bone anchor
placement device 36 has a first end 3a proximal to the handle 2,
and a second end, or head end 3h, distal to the handle 2.
[0087] As in the wrap-around device 1, the shaft 3 of the rack and
rotator manual bone anchor placement device 36 is curved to
facilitate correct placement of the bone anchor placement device 36
to the proper bone anchor screw insertion site, angling upward near
its head end 3h.The upward angle can be from about 0 degrees to
about 90 degrees. In one embodiment of the invention, the upward
angle is between about 35 degrees and about 60 degrees. In the
embodiment of the invention shown in FIG. 15, the upward angle is
approximately 45 degrees. The upward angle of the shaft 3 may be
optimized to facilitate insertion of a bone anchor screw 5. The
shaft 3 can also be rotated about 360 degrees relative to the
handle portion 2 (see dashed arrow in FIG. 15).
[0088] As in the wrap-around manual bone anchor placement device 1,
the rack and rotator manual bone anchor placement device 36 has an
action mechanism through which force on the lever 4 is transmitted
to the force translator 12. The action mechanism includes lever 4,
pivot 9, and the proximal end of the force translator 12. A
torsional spring 10 abuts the lever 4 in the handle 2. The force
translator 12 is connected to the lever 4 by a connector 11, but
the position of the connector 11 relative to the pivot 9 may be
varied. As in the wrap-around manual bone anchor device 1, the
force translator 12 may be rigid (e.g., a rod) or flexible (e.g., a
spring, wire, string, suture material, or the like).
[0089] Unlike the wrap-around bone anchor placement device 1, in
which a pushing force is transmitted to the force translator 12 by
squeezing the lever 4 towards the gripping portion 26 of the handle
2, the rack and rotator bone anchor placement device 36 may be
configured so that either a push force or a pull force may be
transmitted through the force translator 12 by squeezing the lever
4.
[0090] In the "pull" embodiment, shown in FIG. 18A, pivot 9 is
positioned above connector 11. In this embodiment, mechanical
actuation of the lever 4 causes the force translator 12 to be
subjected to tensile loading, i.e., a pulling force, when the user
squeezes the lever 4 toward the gripping portion 26 of the handle
2, and compressive loading when the user releases the lever 4.
[0091] In the "push" embodiment shown in FIG. 18B, pivot 9 is
positioned below connector 11 which connects force translator 12 to
the lever 4. Squeezing the lever 4 in this embodiment causes the
force translator 12 to be subjected to compressive loading, or a
pushing force.
[0092] Force translator 12 runs through the shaft 3 and transmits
linear force exerted manually on the lever 4 to a head assembly 37
positioned at the head end 3h of the shaft 3. Washers 21 positioned
on the inside of the shaft 3 reduce the friction caused by the
force translator 12 contacting the inside surfaces of the shaft 3
(see FIG. 15).
[0093] Head assembly 37 includes a rack 38 and a rotator 14. The
rotator 14 includes at least one protruding portion 15p, and a
coupler 43. Head assembly 37 performs a similar function in the
rack and rotator bone anchor placement device 36 as head assembly
35 does in the wrap-around device 1, translating linear force from
the force translator 12 to rotary force on a bone anchor screw 5,
but does so through a different mechanism.
[0094] As shown in FIG. 16, the distal end of the force translator
12 is coupled to rack 38, which is positioned proximal to rotator
14. The rack 38 is only able to move in the y direction while the
rotator 14 is only able to move rotationally about the x-axis. When
the rack 38 moves into an engaging position relative to the rotator
14, the teeth of rack 38 mesh with the protruding portion 15p of
rotator 14, causing the rotator 14 to rotate. Thus, linear force
transmitted through the force translator 12 translates into
movement of the rack 38 along the y-axis, which in turn translates
into rotation of the rotator 14 about the x-axis. The rotator 14 is
coupled to coupler 43, which is capable of mating with or engaging
a bone anchor screw 5. Rotation of the rotator 14 is translated
into a torque applied on the coupler 43, which in turn drives or
screws a bone anchor screw 5 into bone. Rotators 14 that may be
used with racks 38 of the present invention include ratchet wheels,
pawls, pinions, gears, and the like.
[0095] In the embodiment of the invention shown in FIG. 16, the
rotator 14 is a ratchet wheel. In this embodiment of the invention,
the interior of the head end 3h of the shaft 3 comprises a grooved
element 40 that includes an actuating groove 41 and a return groove
42. A head assembly spring 39 is also positioned within the head
end 3h and is coupled by a first end 39f to the inner wall of the
head end 3h of the shaft 3 distal to rack 38 and at a second end
39s to force translator 12. Squeezing lever 4 exerts a linear pull
force on the translator 12, which mechanically pulls the rack 38
along the actuating groove 41 towards the rotator/ratchet wheel 14.
When the rack 38 reaches an engaging position it engages the
protruding portions 15p of the rotator/ratchet wheel 14 and rotates
the rotator/ratchet wheel 14, which in turn rotates coupler 43.
Coupler 43 engages or mates with a bone anchor screw 5, and
rotation of the coupler 43 applies a torque on the bone anchor
screw 5, thereby screwing it into bone.
[0096] Release of lever 4 by the operator transmits a compressive
force through the force translator 12 (in this embodiment, a
flexible wire) to the head assembly spring 39. A push force exerted
by head assembly spring 39 in response to this compressive force
forces the rack back into return groove 42 during the return stroke
and disengages the rack 38 from the rotator 14.
[0097] The rack and rotator rotary force mechanism shown in FIG. 16
may also be adapted for a push embodiment. In a push embodiment,
compressive loading on the force translator 12 forces the rack 38
forward to engage the rotator/ratchet wheel 14, which rotates in
response to this engagement. The rotation of the rotator/ratchet
wheel 14 rotates coupler 43, which in turn applies torque on a bone
anchor screw 5. By varying the position of the connector 11
relative to the pivot 9 in the action mechanism as shown in FIGS.
18A and 18B, the device 36 may be configured to be used in either a
pull or push embodiment.
[0098] In the embodiment of the invention shown in FIG. 17, the
rotator 14 is a pinion. Rotary motion from the rotator/pinion 14 is
transmitted to a bone anchor screw 5 through coupler 43, which
extends at least partially through the head end 3h of the shaft 3
through opening 200a. A push force or a pull force may be
transmitted through the force translator 12, as discussed above, by
varying the position of the connector 11 relative to the pivot 9 in
the action mechanism of the device 36. A rotator spring 44 provides
an opposing force to return the rotator/pinion 14 to its original
position. In the embodiment of the invention shown in FIG. 17, the
bone anchor screw 5 is pre-attached to a suture 7, and both the
coupler 43 and the rotator/pinion 14 have openings through which
the suture 7 is threaded. The suture 7 dangles from the head end 3h
of shaft 3 through opening 200b.
[0099] FIG. 19 shows an embodiment of the invention in which the
rotator 14 is a pinion, and a compressive force, or push force, is
transmitted on a force translator 12. An opposing compressive force
is provided by rack spring 45, shown in cross-section in the
Figure, that encircles the end of the force translator 12 proximal
to rack 38 and forces the rack 38 back to its original position
during a release stroke.
[0100] FIG. 20 shows a further embodiment of the invention in which
the force translator 12 includes a first wedge member 46 at the end
of the force translator 12 distal to the rack 38. In this
embodiment, the force translator 12 is not directly coupled to the
lever 4, but terminates substantially at the neck 47 of the head
end 3h of the shaft 3. The translator 12 receives force from a
tubular member 48 that terminates in a second wedge member 49 and
is connected to the lever 4 at connector 11. Actuation of the lever
4 pushes the second wedge member 49 against the first wedge member
46 and transmits a compressive force, i.e., a push force, to the
force translator 12. During the release stroke, rotator spring 44
forces the rotator/pinion 14 back to its original position while
rack spring 45 forces the rack 38 into its initial position.
[0101] FIG. 21 shows a further embodiment of the invention in which
hydraulic or pneumatic pressure is used to exert a compressive, or
push force, on a force translator 12p. In this embodiment of the
invention, the force translator 12p is a plunger positioned in
close proximity to the rack 38. An o-ring 50 maintains a seal
separating air or fluid in the shaft 3 from the rack 38 and
rotator/pinion 14 assembly. Hydraulic or pneumatic forces
transmitted through the shaft 3 upon actuation of the lever 4 drive
the plunger 12p forward, transmitting linear force from the plunger
12p to the rack 38, which is in turn pushed forward to engage the
rotator/pinion 14. The rotator/pinion 14 rotates and transmits
rotary force to coupler 43, which applies a torque to a bone anchor
screw 5. Opposing compression forces from rotator spring 44 forces
the rotator/pinion 14 back to its original position while rack
spring 45 forces the rack 38 to return to its initial position.
[0102] As will be readily apparent to those of ordinary skill in
the art, many of the features of the wrap-around manual bone anchor
placement device 1 may be adapted for use with the rack and rotator
manual bone anchor placement device 36. For example, a suture 7
pre-attached to a bone anchor screw 5 may be clipped to the shaft 3
by suture rings 8 to keep the suture 7 from becoming entangled
during the bone anchor screw 5 insertion procedure. Alternatively,
the suture 7 may be enclosed within a flexible, molded sleeve 24
press-fitted into a groove 23 cut into the handle 2. A retaining
clip 27 provided at the end of the sleeve 24 proximal to the
gripping portion 26 of the handle 2 may be provided to prevent the
suture 7 from slipping out of the sleeve 24 before the bone anchor
screw 5 is screwed into bone.
[0103] The coupler 43 may also be configured to be adapted to a
wide variety of bone anchor screws 5. Like the securing element 166
of the wrap-around bone anchor placement device 1, the coupler 43
of the rack and rotator manual bone anchor placement device 36
includes a mating portion 43m that extends at least partially
outside head end 3h of the shaft 3 and which can be fabricated to
complement different types of bone anchor screws 5. In the
embodiment of the invention shown in FIG. 19, the coupler 43
provides a mating portion 43m that is a hex-shaped recess that
seats a bone anchor screw 5 with a hex-shaped shaft 5a, (e.g., as
shown in FIG. 5E). The mating portion 43m of the coupler 43 may be
configured in any type of shape (e.g., shaft or recess) that allows
for frictional and mechanical engagement with a bone anchor screw 5
having the corresponding shape (e.g., recess or shaft).
[0104] As with the wrap-around manual bone anchor placement device
1, a protective cover 32 may be provided to protect the tip of the
bone anchor screw 5 from damage before it contacts a bone insertion
site, and may be collapsible to expose the bone anchor screw 5 only
when it contacts the bone.
[0105] As with the wrap-around manual bone anchor placement device
1, the rack and rotator bone anchor placement device 36 may be
fabricated in a modular configuration to provide for the ready
interchange of different head modules and shaft modules. For
example, a shaft 3 that has a rack and rotator head assembly 37 may
be interchanged with a shaft 3 having the same type of head
assembly 37, but with a different angle of curvature.
Alternatively, a shaft 3 with a rack and rotator head assembly 37
may be interchanged with a shaft 3 having a wrap-around head
assembly 35. Similarly, different couplers 43 may be interchanged
to facilitate the use of different bone anchor screws 5.
[0106] Cup and Washer Manual Bone Anchor Placement Device
[0107] As with the previously disclosed manual bone anchor
placement devices 1 and 36, the cup and washer manual bone anchor
placement device 52, is configured to be substantially pistol- or
gun-shaped, having a handle 2 with a gripping portion 26 and a
lever 4. In the cup and washer manual bone anchor placement device
52, however, the "barrel of the gun" is formed by a driver rod 53
that extends through the handle 2 and is substantially
perpendicular along its length to the longitudinal axis of the
gripping portion 26 of the handle 2.
[0108] FIGS. 22A and 22B show a cross-section of the cup and washer
manual bone anchor placement device 52. The driver rod 53 includes
a smooth portion 54 and a lead screw portion 55 with integral
single or multistart threads 55t. The lead screw portion 55 may be
integral with the smooth portion 54. Alternatively, the lead screw
portion 55 may be screwed onto threads or grooves at one of the
ends of the smooth portion 52. The lead screw portion 55 may extend
from one end of the handle 2 to the other end of the handle 2 or
the lead screw portion 55 may comprise a substantial portion of the
driver rod 53. As used herein, "a substantial portion" refers to
greater than 50% of the length of the driver rod 53. In a different
embodiment of the invention, the driver rod 53 may be flat stock
twisted into a spiral with a long pitch.
[0109] The lead screw portion 55 of the driver rod 53 further
includes an engaging element 55e at the end of the lead screw
portion 55 distal to smooth portion 52 of the driver rod 53. The
engaging element 55e engages with a coupling member 59. The
coupling member 59 has a mating portion 59m for mating with a bone
anchor screw 5 and an engaging portion 59e for engaging with the
engaging element 55e of the lead screw portion 55.
[0110] The position of the coupling member 59 relative to the lead
screw portion 55 of the driver rod 53 may be controlled by means of
a coupling member stop 59s. A chuck 57 provided at the barrel end
56 of the handle 2 further secures coupling member 59 to the lead
screw portion 55 of the driver rod 53. Since the chuck 57 contacts
both the lead screw portion 55 of the driver rod 53 and the
coupling member 59, any force transmitted through the driver rod 53
is also transmitted through the coupling member 59 to the bone
anchor screw 5. In a further embodiment of the invention, a
rotatable twist lock 58 is provided, thereby supplying an
additional means of securing the chuck 57 to coupling member
59.
[0111] The rotary force mechanism in the cup and washer manual bone
anchor placement device 52 includes cup and washer assembly 60,
which includes a cup 61, a washer 62, and at least one engaging pin
65. The cup 61 is capable of axial movement along the lead screw
portion 55 of the driver rod 53, while the washer 62 is capable of
both axial motion and rotational motion along the lead screw
portion 55.
[0112] Movement of the cup 61 is controlled by actuation of an
action mechanism that includes a lever 4 and a force-translating
member 64. The force-translating member 64 has a first end 64f and
a second end 64s. The first end 64f of the force-translating member
64 is coupled to the lever 4 at pivot point 9 while the second end
64s is coupled to the side of the cup 61 by means of flanges 61f on
the cup. The flanges 61f form a yoke that links the cup 61 to the
force-translating member 64. The cup 61 is thus free to ride on the
lead screw 55 in response to movement of force translating member
64.
[0113] The cup and washer manual bone anchor placement device 52
operates on the principle of a child's top. Applying a linear force
on the lever 4 by squeezing it towards the gripping portion 26 of
the handle 2 actuates the action mechanism. Linear force is
transmitted from the lever 4 to the force-translating member 64 and
is transmitted to cup 61. In the embodiment of the invention shown
in FIG. 23, the cup 61 has two engaging pins 65 that fit into
complementary holes 66 in the washer 62. The cup 61 is capable of
engaging and disengaging the washer 62 depending upon its direction
of travel, while the washer 62 includes protrusions 67 that allow
it to move along and follow the thread pitch of the threads 55t of
the lead screw portion 55 of the driver rod 53. In the embodiment
of the invention shown in FIG. 23A, the lead screw portion 55
includes grooves 66g complementary to protrusions 67 in the washer
62. In the embodiment of the invention shown in FIGS. 24A and 24B,
the engaging pins 65 of the washer 62 further include tangs 65t,
and the cup 61 includes ribs 71 that constrain the motion of the
washer 62 further when the tangs 65t of the washer 62 contact the
walls of the ribs 71.
[0114] Upon squeezing the lever 4, the translating member 64 is
driven forward, moving the cup 61 forward at the same time (see
dashed arrows in FIGS. 22A and B). When the motion of the cup 61 is
initiated, the washer 62 is forced by the lead screw portion
threads 55t into contact with the cup 61. The engagement pins 65 of
the cup 61 then engage with the washer 62. Once engaged, the washer
62 is no longer free to rotate or spin on the lead screw portion
threads 55t. As the translational member 64, cup 61, and washer 62,
advance in a linear, forward direction, linear force from the force
translating member 64 on the cup 61 is translated into rotary force
upon the lead screw portion 55 of the driver rod 53, causing the
driver rod 53 and the coupling member 59, which is coupled to it,
to twist as the washer 62 follows the threads 55t of the lead screw
portion 55. This twisting motion in turn applies a torque to a bone
anchor screw 5 engaged by the coupling member 59, thereby screwing
the bone anchor screw 5 into bone.
[0115] On the lever return stroke, there is minimal linear force
imposed upon the coupling member 59. The cup 61 provides the washer
62 with clearance to disengage from the engaging pins 65 of the cup
61 and to rotate freely as the washer 62 follows the threads 55t on
the lead screw portion 55 of the driver rod 53. In a further
embodiment of the invention, shown in FIG. 22B, a return coil
spring 68 may provided at the barrel end 56 of the handle 2 to
further apply a return compressive force on the cup 61 and
translating member 64 when the lever 4 is released.
[0116] By incorporating a 60-degree pitch angle and 3-start thread,
the complete seating of a bone anchor screw 5 can take place in
approximately 10 strokes of the lever 4. Optimizing thread 55t
design, lever 4 stroke and/or cup 61/washer 62 clearance can reduce
the number of strokes.
[0117] It should be readily apparent to one of ordinary skill in
the art that the engaging pins 65 may be provided on the washer 62
side rather than the cup 61 side and that the holes 66 may be
provided in the cup 61. The number of engagement pins 65 may also
be varied. The engaging pins 65 may be an integral part of the
washer 62 or cup 61, or may be removable from the washer 62 or cup
61. In addition, the number of starts in the multistart thread 55t
of the lead screw portion 55 of the driver rod 53 may be varied
from one through what ever number is dimensionally practical for
the driver rod 53 diameter.
[0118] In a further embodiment of the invention as shown in FIGS.
22A, 22B, 24A, and 25B, a cover plate 63 is provided at the rim 69
of the cup 61 to contain the washer 62 within the cup 61 and to
permit only minimal travel space for the washer 62 to move in when
it is drawn free from the engaging pins 65 of the cup 61.
[0119] As with the previously disclosed manual bone anchor
placement devices 1 and 36, the cup and washer manual bone anchor
placement device 52 may be used with a bone anchor screw 5 with a
pre-attached suture 7 that may be enclosed within a sleeve 24
press-fitted into a groove 23 cut into handle portion 2. The mating
portion 59m of the coupling member may be configured to mate with a
variety of bone anchor screws 5, and may include a shaft configured
in a shape complementary to a recess in a bone anchor screw 5 or
may include a recess complementary to a shaft in a bone anchor
screw 5. As in the previously disclosed devices 1 and 36, the cup
and washer manual bone anchor placement device 52 may include a
modular design allowing for the interchange of different types of
coupling members 59. The handle portion 2 may also be configured to
include two separable halves that are able to snap-fit together,
allowing removal of one driver rod and/or cup and washer assembly
and replacement with another.
[0120] Self-Tapping Bone Anchor Screw
[0121] FIG. 26 shows a bone anchor screw 5 according to one
embodiment of the invention. As shown in the FIG. 26, the threads
of the bone anchor screw 5 are of buttress form. The forward face
72 of the screw thread is perpendicular to the longitudinal axis 73
of the bone anchor screw 5 while the back face 74 of the screw
thread is at an acute angle relative to the longitudinal axis 73 of
the bone anchor screw 5. The threads extend to the tip of the screw
shank 75, reducing the amount of torque required to seat the bone
anchor screw 5. In one embodiment of the invention, the back face
74 of the screw thread is at about a 30-degree angle relative to
forward face 72 of the screw thread.
[0122] The base 76 of the bone anchor screw 5 shown in FIG. 26A has
an eyelet 77 that is circular and has micropolished edges. In
another embodiment of the invention, the eyelet 77 at base 76 may
be teardrop shaped, or ellipsoidal. Other configurations may be
used so long as the edges are rounded so as not to damage the
suture 7. Micropolishing the eyelet 77 rounds the edges and reduces
load to the suture 7 that may be caused by twisting (torsional
load) during insertion, the user tugging on the suture 7 to test
seating of the screw, and bodily movement while the anchor screw
and suture are in place.
[0123] According to a further embodiment of the invention, kits
including the disclosed self-tapping bone anchor screw may be
provided for the convenience of the user. In one embodiment of the
invention, a kit is provided, including at least one of: 1) a
flexible, molded sleeve 24 for enclosing a suture 7, 2) a retaining
clip 27 for preventing the suture 7 from slipping out of the sleeve
24, 3) a buttress-shaped bone anchor screw 5 with a micropolished
eyelet 77 for receiving the suture 7, and 4) suture material, which
may or may not, be pre-attached to the bone anchor screw 5. The kit
may include any one of these elements or combinations thereof.
[0124] Recessed Bone Anchor Mount
[0125] The recessed bone anchor mount is designed to be used in
conjunction with the various bone anchor placement devices
described hereinabove; however, the recessed mount is not limited
to use with only those types of bone anchor placement devices.
[0126] FIG. 27A is a perspective view of one embodiment of a bone
anchor placement device 210 constructed according to the present
invention. The anchor placement device 210 includes a handle 212,
and a shaft 214 extending in a distal direction from the handle
212. A head assembly 216 is disposed at a distal end 218 of the
shaft 214, and defines a core 220 that may be further defined by
driver guide 300. A recessed anchor mount 222 is fixedly engaged
within the core 220. In one embodiment, the handle 212 includes an
actuator 224 for actuating a mechanism 226 for advancing or
retracting the anchor mount 222.
[0127] The handle 212 serves as a gripping area for a surgeon, and
is preferably of a size that makes it easily grippable by a user. A
handle that is at least about 4 inches (100 mm) in length has been
found to work well. The handle 212 may be made of any relatively
firm material, including plastic or metal. For example, the handle
212 may be made of plastic, aluminum, stainless steel, or titanium.
Those skilled in the art will appreciate that a wide range of other
materials may also be employed. The handle 212 may be configured in
any of a variety of shapes compatible with vaginal insertion of the
anchor placement device 210. In the embodiment shown in FIG. 27A,
the handle 212 tapers towards the proximal end to facilitate
gripping by the user. Preferably, the handle 212 is provided with
knurling or other surface texturing to produce a high friction,
non-slip gripping surface.
[0128] The shaft 214 extends in a distal direction from the handle
212, and is adapted for releasably engaging a bone anchor 230. The
shaft 214 has a distal end 218, and a proximal end 228. The shaft
214 may be curved or angled at one or more portions to facilitate
correct placement of the bone anchor placement device 210 to a
proper bone anchor insertion site. The shaft 214 may be made of any
of a variety of materials; including steel, stainless steel,
aluminum, titanium, and plastic, but is preferably made of
stainless steel. The shaft 214 may have a variety of
cross-sectional shapes including round, elliptical, rectangular,
hexagonal, or triangular, but preferably the shaft 214 has a round
cross-section.
[0129] The length of the shaft 214 is consistent with transvaginal
delivery of a releasable bone anchor 230 and may be of an
appropriate length to permit access of the bone anchor 230 to the
desired location. The cross-sectional dimension of the shaft 14 is
a function of the force-translating mechanism (variations of which
are described hereinabove) and the actuator mechanism 226 and may
range from about 0.2 to about 1.0 inch in diameter.
[0130] FIG. 28A is an enlarged view of one embodiment of a recessed
anchor mount 222 constructed according to the present invention and
of a bone anchor 230 for attachment to the anchor mount 222. The
mount 222 has a distal end 223 and a proximal end 229. In one
embodiment, the mount 222 has a hexagonal interior lumen 232, and a
matching or complimentary outer surface 234. The mount 222 may have
other configurations for its interior lumen 232 and outer surface
234, such as a rectangular, pentagonal, octagonal, or round. FIG.
28B depicts an end view of an alternative anchor mount 222 with a
primarily round outer surface 234 and a groove 235 for interlocking
with a pin or protuberance (not shown) within the driver guide 300.
FIG. 28C depicts an end view of an alternative anchor mount 222
with a primarily round outer surface 234 and a flat surface 237 for
interlocking with a mating flat surface (not shown) within the
driver guide 300.
[0131] A variety of bone anchors 230 can be used. In one
embodiment, the bone anchor 230 includes a spear member 236 that is
able to pierce and securely engage a bone or bone tissue. The spear
member 36 has a generally cone shaped head portion 238 which is
used to pierce the bone and a shaft portion 240 with an eyelet 242
therethrough for receiving and holding one or more suture strands
241.
[0132] The outer surface of the shaft portion 240 of the anchor 230
is shaped to fit within the anchor mount 222, and is adapted to
rotate with the anchor mount 222. In preferred embodiments, the
shaft portion 240 has the eyelet 242 formed radially therethrough
proximate one of its ends. The eyelet 242 may be of any shape and
is of a sufficient size to permit a suture strand or strands 241 to
pass therethrough. The circumference of each outer end of the
eyelet 242 is preferably chamfered or grounded to provide a beveled
surface. A beveled surface provides a generally smooth surface for
contacting a suture strand 41 that has been passed through the
eyelet 242. The eyelet 242 is preferably located on the shaft
portion 240 of the anchor 230 such that the transverse axis of the
eyelet 242 intersects the longitudinal axis of the spear member
236.
[0133] The generally cone-shaped head portion 238 of the spear
member 236 is located at an end of the shaft portion 240 opposite
the end having the eyelet 242. The apex of the cone-shaped head
portion may terminate in a sharp tip or point 243 that is suitable
for being driven into bone. The diameter of the cone-shaped head
portion 238 increases, when viewed along its longitudinal direction
rearwardly from the point 243, towards the shaft portion 240.
[0134] Any known materials suitable for orthopedic anchor devices
may be employed to construct the bone anchor 230 of the present
invention. Preferably, the bone anchor 230 is formed from a plastic
polymer or metallic material possessing sufficient strength to
penetrate and anchor to bone. Such materials include titanium, 316
LVM stainless steel, CoCrMo alloy, Nitinol alloy, or polymers, for
example, polyglycolic acid (PGA) with or without absorbability
properties. Preferably, the bone anchor is made of titanium.
[0135] FIG. 29A is an enlarged view of one embodiment of the head
assembly 216 of the anchor placement device 210 of FIG. 27A, and a
recessed anchor mount 222 housed within the head assembly 216 in a
retracted position.
[0136] The head assembly 216 is capable of releasably engaging a
bone anchor mount 222 and is connected to a mechanism 226 that
translates axial motion to the mount 222 to advance or retract the
anchor 230. The head assembly 216 defines a hollow core 220 that
may be further defined by driver guide 300. The interior dimensions
of the core 220, or driver guide 300, permit a recessed anchor
mount 222 to be moveably fitted therein. In preferred embodiments,
the interior dimensions of the core 220, or driver guide 300, are
only slightly larger than the exterior dimensions of the anchor
mount 222. The length of the anchor mount 222 is about 0.12 to
about 0.25 inches, preferably about 0.15 to about 0.20 inches, and
more preferably about 0.185 inches. The length of the driver guide
300 is essentially the length of the anchor mount 222 and the
anchor 230.
[0137] In preferred embodiments, the core 220 has a shape
complementary to the proximal end 229 of the anchor mount 222, so
as to permit the mount 222 to engage the driver guide 300. For
example, the driver guide 300 and the proximal end 229 of the
anchor mount 222 may be square, rectangular, pentagonal, triangular
or hexagonal in cross-section. In some embodiments, the driver
guide 300 and the proximal end 229 of the anchor mount 222 have
hexagonal cross-sections; however, those skilled in the art will
appreciate that numerous shapes may be employed and the present
invention specifically contemplates any such shape. In some
embodiments, driver guide 300 includes a stop 247 disposed on the
interior surface of the driver guide 300. In alternative
embodiments, the stop is disposed on the mechanism 226 and limits
the travel of the mechanism 226, and thereby limits the travel of
the anchor mount 222. The stop 247 prevents driving the bone anchor
230 too far into the bone.
[0138] In some embodiments, the mechanism 226 that translates
motion to the mount 222 is a push wire 246a. Alternatively, the
mechanism 226 could be a pull wire 248b as depicted in FIGS. 30A
and 30B. The mechanism 226 operates on the same principle whether a
push wire 246a or a pull wire 246b is used, and the following
description is directed only to a push wire 246a for simplicity.
The push wire 246a is coupled to the anchor mount 222 via a point
contact, as shown in FIG. 29C, to advance or retract the anchor
mount 222. Alternatively, the push wire 246a may be secured to the
anchor mount 222. For example, the push wire 246a may be welded or
crimped to the anchor mount 222, in which case the push wire 246a
must be able to twist and roll freely within the shaft 214. In such
embodiments, the actuator to push wire connection is preferably
non-fixed. In alternative embodiments, the push wire 246a may be
coupled to the anchor mount 222 via a free-floating mechanism 247,
as shown in FIG. 29D.
[0139] As shown in FIGS. 27A and 30A, the push/pull wire 246a,b is
a substantially linear member that extends from the handle 212. The
push/pull wire 246a,b is made of a high tensile material. Suitable
push wire materials include metals, plastics, and reinforced
polymers. In preferred embodiments, the push/pull wire 246a,b is
made of spring steel, or superelastic nitinol. In some embodiments,
a groove or channel 248 is cut into the outer surface of the shaft
214, extending in a line substantially parallel to the longitudinal
axis of the shaft 214. Alternatively, the groove or channel may be
otherwise formed as part of the shaft 14 and may completely
encapsulate the push/pull wire 246a,b and/or mechanism 226, for
examples see FIGS. 27B-27E. The push/pull wire 246a,b is situated
within the channel 248 disposed on the shaft 214. In some
embodiments, an actuator 224, such as a button, lever, or trigger
disposed on the handle 212, activates the push/pull wire 246a,b.
Force exerted on the actuator 224 is translated to the anchor mount
222 as linear force through the push/pull wire 246a,b.
[0140] During insertion of the device 210 into the body, the anchor
mount 222, as well as an attached bone anchor 230, remain in a
recessed position, as shown in FIG. 29A. The sharp tip 243 of the
anchor 230 therefore remains unexposed to bodily tissue. The
likelihood of tearing and scraping of tissue, as well as injury to
delicate abdominal organs, is thereby reduced. Because the bone
anchor 230 remains protected within the hollow core 220 of the head
assembly 216, the likelihood of dislodgment of the bone anchor 230
during insertion is also reduced. The need for protective covers or
sheaths for the purpose of shielding the tip 243 of the anchor is
also reduced. Furthermore, when the anchor mount 222 is recessed,
the profile of the head assembly 216 is reduced in comparison to
the configuration where the anchor mount 222 protrudes from the
head assembly 216. Therefore, a smaller vaginal incision is
required, as compared to the situation where a protective shroud or
cover is provided for the bone anchor 230.
[0141] FIG. 29B is an enlarged view of one embodiment of a head
assembly 216 of an anchor placement device 210 of FIG. 27A, and a
recessed anchor mount 222 protruding from the head assembly
216.
[0142] In operation, when a force is exerted on the actuator 224 by
pushing, pulling, or otherwise actuating the actuator 224, the
exerted force is translated as a linear force through the push/pull
wire 246a,b to the anchor mount 222. Optionally, the actuator 224
can be locked in place to prevent the anchor mount 222 from
retracting. As the exerted linear force is transmitted to the
anchor mount 222 through the push/pull wire 246a,b, the anchor
mount 222 advances linearly, moving within the driver guide 300.
The attached bone anchor 230 may advance with the anchor mount 222
until halted by the optional stop 247 disposed within the driver
guide 300. In an alternative embodiment, the mechanism 226 may also
actuate a force-translating mechanism (variations of which are
described hereinabove), and thereby turn the anchor mount 222 in
response to the applied force.
[0143] Having thus described certain embodiments of the present
invention, various alterations, modifications, and improvements
will be obvious to those skilled in the art. Such variations,
modifications and improvements are intended to be within the spirit
and scope of the invention. The materials employed, as well as
their shapes and dimensions, generally can vary. Accordingly, the
foregoing description is by way of example only and is not intended
to be limiting.
* * * * *