U.S. patent application number 14/846076 was filed with the patent office on 2017-03-09 for torque limiting surgical screw driver.
The applicant listed for this patent is Xenco Medical, LLC. Invention is credited to Gustavo R. PRADO, Ryan WOODS.
Application Number | 20170065322 14/846076 |
Document ID | / |
Family ID | 58017479 |
Filed Date | 2017-03-09 |
United States Patent
Application |
20170065322 |
Kind Code |
A1 |
PRADO; Gustavo R. ; et
al. |
March 9, 2017 |
TORQUE LIMITING SURGICAL SCREW DRIVER
Abstract
Described herein are devices and methods for limiting the torque
applied to surgical screw during a surgical procedure in which a
surgical screw is passed into a vertebra, such as, for example, a
spinal fusion procedure. A surgical screw driver is configured to
prevent an excessive amount of torque from being delivered to the
vertebrae through a surgical screw. When an excessive amount of
torque is delivered to the handle of a surgical screw driver, it is
prevented from being transmitted to the surgical screw and is thus
not delivered to the vertebrae. Excessive force in the form of
excessive torque transmitted to a vertebrae may cause a fracture
along with possible mispositioning or displacement of a surgical
screw.
Inventors: |
PRADO; Gustavo R.; (San
Diego, CA) ; WOODS; Ryan; (San Diego, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Xenco Medical, LLC |
San Diego |
CA |
US |
|
|
Family ID: |
58017479 |
Appl. No.: |
14/846076 |
Filed: |
September 4, 2015 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/0023 20130101;
A61B 2017/00424 20130101; A61B 2017/0046 20130101; A61B 2090/031
20160201; A61B 2017/00407 20130101; A61B 17/8888 20130101 |
International
Class: |
A61B 17/88 20060101
A61B017/88 |
Claims
1. A torque limiting surgical screw driver, comprising a driver
shaft having a proximal end and a distal end, wherein the proximal
end comprises a first torque limiting element, and wherein the
distal end is configured to engage with a screw head used in a
surgical procedure; and a handle coupled with the proximal end of
the driver shaft, wherein the handle comprises a first opening
configured to receive the proximal end of the driver shaft; a
hollow interior continuous with the opening, and a second torque
limiting element within the hollow interior positioned to engage
the first torque limiting element on the proximal end of the driver
shaft; a track positioned on the hollow interior of the handle and
contiguous with the second torque limiting element; wherein the
first torque limiting element and the second torque limiting
element are configured to disengage from each other when a torque
above a first threshold torque is applied to the handle when the
handle is rotated in a clockwise direction; and wherein the first
torque limiting element comprises a leaflet comprising a first and
a second portion, wherein the first portion and the second portion
are joined to form an elbow in the leaflet; wherein the second
portion of the leaflet comprises a rounded lip; and wherein the
rounded lip is positioned to contact the track on the hollow
interior of handle when the first torque limiting element and the
second torque limiting element disengage and the handle is rotated
in a clockwise direction.
2. The torque limiting surgical screw driver of claim 1, wherein
the driver shaft has a length of about 30 cm.
3. The torque limiting surgical screw driver of claim 1, wherein
the elbow forms an angle of 90 degrees or less.
4. The torque limiting surgical screw driver of claim 1, wherein
the handle is configured to reversibly couple with the driver shaft
via a coupling mechanism.
5. The torque limiting surgical screw driver of claim 4, wherein
the coupling mechanism comprises one or more threaded
components.
6. The torque limiting surgical screw driver of claim 4, wherein
one or more of the driver shaft and the handle are disposable.
7. The torque limiting surgical screw driver of claim 1, wherein
the second torque limiting element is positioned so as to engage
the first torque limiting element in a side by side fashion when
the driver shaft is coupled with the handle.
8. The torque limiting surgical screw driver of claim 1, wherein
the first torque limiting element is configured to bend in response
to a pressure applied to the first torque limiting element by the
second torque limiting element when the torque above the first
threshold torque is applied to the handle causing the first torque
limiting element to disengage from the second torque limiting
element.
9. The torque limiting surgical screw driver of claim 1, wherein
the first threshold torque comprises 90 inch pounds of torque.
10. The torque limiting surgical screw driver of claim 1, wherein
the handle comprises a third torque limiting element within the
hollow interior, and wherein the first torque limiting element on
the driver shaft is positioned between the second and third torque
limiting elements when the handle is coupled with the driver
shaft.
11. The torque limiting surgical screw driver of claim 10, wherein
the first torque limiting element and the third torque limiting
elements are configured to disengage from each other when a torque
above a second threshold torque is applied to the handle when the
handle is rotated in a counter-clockwise direction.
12. The torque limiting surgical screw driver of claim 1, wherein
the handle further comprises a snap-fit connector for forming a
snap-fit connection to a handle arm, and wherein the snap-fit
connector comprises a second opening in the handle.
13. A method for limiting the amount of torque delivered to a
surgical screw, comprising providing to a user a surgical screw
driver with a torque limiting mechanism comprising a handle
configured to couple with and rotate about a driver shaft, and
further comprising two or more torque limiting elements that engage
each other so that they together create a resistance to clockwise
rotation of the handle about the driver shaft when the driver shaft
is engaged with a surgical screw head of the surgical screw, until
the user applies a torque above a first threshold torque to the
handle in a clockwise direction that causes the two or more torque
limiting elements to disengage so that the torque above the first
threshold torque is not applied to the surgical screw head; wherein
the first torque limiting element comprises a leaflet comprising a
first and a second portion, wherein the first portion and the
second portion are joined to form an elbow in the leaflet; wherein
the second portion of the leaflet comprises a rounded lip; and
wherein the rounded lip is positioned to contact the track on the
hollow interior of handle when the first torque limiting element
and the second torque limiting element disengage and the handle is
rotated in a clockwise direction.
14. The method of claim 13, wherein the driver shaft has a length
of 30 cm.
15. The method of claim 13, wherein the two or more torque limiting
elements comprise a first torque limiting element and a second
torque limiting element, and wherein the first torque limiting
element is positioned on the driver shaft and the second torque
limiting element is positioned on the handle.
16. The method of claim 15, wherein the one or more torque limiting
elements on the handle is positioned so as to engage the first
torque limiting element in a side by side fashion when the driver
shaft is coupled with the handle.
17. The method of claim 15, further comprising a third torque
limiting element.
18. The method of claim 17, wherein the third torque limiting
element is configured to together create a resistance to
counter-clockwise rotation of the handle about the driver shaft
when the driver shaft is engaged with a surgical screw head of the
surgical screw, until the user applies a torque above a second
threshold torque to the handle in a counter-clockwise direction
that causes the two or more torque limiting elements to disengage
so that the torque above the threshold torque is not applied to the
surgical screw head.
19. The method of claim 13, wherein the leaflet comprises an elbow
bend comprising an angle of 90.
20. The method of claim 13, wherein the handle is configured to
reversibly couple with the surgical screw driver via a coupling
mechanism.
21. The method of claim 20, wherein the coupling mechanism
comprises one or more threaded components.
22. The method of claim 13, wherein at least one of the two
portions of the leaflet are configured to bend in response to a
pressure applied to the at least one of the two portions of the
leaflet when the first threshold torque is applied to the handle
causing the two or more torque limiting elements to disengage.
23. The method of claim 13, wherein the first threshold torque
comprises 90 inch pounds of torque.
24. The method of claim 13, further comprising replacing one or
more of the drive shaft and the handle.
25. A method for adjusting the amount of torque applied by a torque
limiting surgical screw driver, comprising providing to a user a
torque limiting surgical screw driver comprising a plurality of
torque limiting elements configured to engage each other and a user
controllable torque adjusting mechanism, wherein the user
controllable torque adjusting mechanism is configured to cause one
or more torque limiting elements of the plurality of torque
limiting elements to reposition relative to one on or more torque
limiting elements of the plurality of torque limiting elements so
that a surface area over which the plurality of torque limiting
elements engage is either increased or decreased.
26. The method of claim 25, wherein the user controllable torque
adjusting mechanism comprises a threaded piece.
27. The method of claim 25, wherein the user controllable torque
adjusting mechanism comprises a slideable switch.
28. The method of claim 25, wherein the user controllable torque
adjusting mechanism is configured to modify a resistance to a
torque applied to the torque limiting surgical screw driver.
29. The method of claim 25, wherein the resistance to a torque
applied to the torque limiting surgical screw driver is modified by
up to 10 inch pounds of torque.
30. The torque limiting surgical screw driver of claim 1,
comprising at least two second torque limiting elements.
Description
BACKGROUND
[0001] Intervertebral disc disease and disc erosion as well as
vertebral disease and vertebral deformity can cause severe back
pain, and the typical pathophysiology of chronic back pain is a
compression of a spinal nerve due to one of these spinal
abnormalities.
[0002] When two vertebral bodies are separated by an eroded
intervertebral disc, it can lead to a vertebral body collapsing
onto the vertebral body directly below it. The collapse of the
first vertebral body onto the second vertebral body deforms the
vertebral anatomy, which can lead to a compression or pinching of a
spinal nerve that can be exacerbated with motion.
[0003] The compression or pinching of a spinal nerve typically
causes severe radiating pain down the distribution of the
compressed or pinched nerve.
[0004] A typical surgical treatment for a compressed or pinched
spinal nerve is a spinal fusion procedure. A spinal fusion
procedure fuses two or more vertebrae together to eliminate the
motion of these vertebrae, thus alleviating the nerve compression
due to abnormal motion of the vertebrae.
[0005] A typical way to perform a spinal fusion procedure is by
placing pedicle screws through the vertebral pedicles and into the
vertebral bodies of two or more collapsed vertebra, and then
attaching supporting bars to the pedicle screws. The supporting
bars attached to the pedicle screws that are positioned within the
vertebrae function similarly to scaffolding, connecting and fixing
vertebrae together by fixing together pedicle screws embedded in
the vertebrae.
[0006] A pedicle screw typically comprises a reticulating head
referred to as a tulip. After the pedicle screw has been placed, a
tulip may be used to align and secure a supporting bar that is
coupled with that tulip. Once a desired position of a supporting
bar is achieved a setscrew is used to fix the supporting bar to the
tulip.
[0007] Torque applied to the pedicle screw and tulip setscrew to
achieve proper placement and proper vertebral fixation is
transferred to the vertebral pedicle and vertebral body. Too much
torque applied to either the pedicle screw or tulip may fracture
the vertebra through which a pedicle screw is placed or cause
damage to the pedicle screw assembly.
[0008] Numerous other orthopedic procedures involve the placement
of screws into bone, including, for example, bone fixation devices
such as those used in long bone fracture reductions and fixations
and in halos. Similar to vertebral fixation, too much torque
applied when a screw is placed into a bone may cause fracture of
the bone tissue or failure of the medical device.
SUMMARY
[0009] Described herein are methods and devices for limiting the
torque applied to a screw or other similar device such as a bone
tap being placed into bone as part of an orthopedic or
neurosurgical procedure. Torque in various surgical procedures is
typically applied by a hand-held instrument that is powered by a
surgeon. A hand-held instrument may be similar to a traditional
screw driver.
[0010] A torque limiting surgical screw driver and methods for
limiting the torque that is applied to a screw being passed through
a bone are beneficial, for example, in preventing bone fracture. In
an embodiment, a torque limiting surgical screw driver may be
configured to prevent the application of torque above a set
threshold torque level to a surgical screw that may be used in, for
example, an orthopedic or surgical procedure.
[0011] Traditional surgical screwdrivers and similar devices
typically require recalibration following repeated steam
sterilization undergone between surgical procedures. [Sadr et. al.]
This poses a significant risk to patients, because it is difficult
to track usage of such devices in the operating room, which makes
recalibration difficult to do and as a result leaves recalibration
schedules often unfulfilled. A low-cost, sterile-packaged, and
disposable torque limiting surgical screw driver would be
beneficial because such a screw driver would obviate the need for
constant recalibration of re-used surgical screw drivers, which as
explained are difficult to constantly recalibrate.
[0012] A low-cost, sterile-packaged, and disposable torque limiting
surgical screw driver would offer significant benefits over
currently available options. In order for a disposable device to be
cost-effective, manufacturing methods such as plastic injection
mold may be utilized. The challenge posed by injection-mold
manufacturing is that molds that form instruments are expensive and
hard to change once made. In addition, torque limiting devices
usually need to be calibrated in order to precisely limit torque at
a prescribed value. Described herein is an injection-moldable
design and manufacturing method that is easily fine-tunable to the
desired torque value.
[0013] Described herein is a torque limiting surgical screw driver,
comprising a driver shaft having a proximal and a distal end,
wherein the proximal end of the driver shaft comprises a first
torque limiting element, and wherein the distal end of the driver
shaft is configured to engage with a screw head used in a surgical
procedure; a handle configured to couple with the proximal end of
the driver shaft, wherein the handle comprises an opening
configured to receive the proximal end of the driver shaft and a
hollow interior continuous with the opening, and wherein the handle
comprises a second torque limiting element within the hollow
interior; wherein the second torque limiting element within the
hollow interior of the handle is positioned to engage the first
torque limiting element on the proximal end of the driver shaft
when the proximal end of the driver shaft is coupled with the
handle; and wherein the first and the second torque limiting
elements are configured to disengage when a torque above a first
threshold torque is applied to the handle when the handle is
rotated in a clockwise direction. In an embodiment, the driver
shaft has a length of about 30 cm. In an embodiment, the first
torque limiting element comprises a leaflet comprising a first and
a second portion, wherein the first portion is substantially
rectangular and is positioned substantially perpendicular to the
driver shaft, and wherein the second portion is substantially
rectangular and further comprises a rounded lip at its distal end.
In an embodiment, the proximal end of the driver shaft further
comprises a third, a fourth, and a fifth torque limiting elements
that are configured to respectively engage a sixth, a seventh, and
an eighth torque limiting elements within the hollow interior of
the handle. In an embodiment, the first torque limiting element
comprises an elbow bend comprising an angle of 90 degrees or less.
In an embodiment, the first torque limiting element comprises a
polymer or plastic. In an embodiment, the handle is configured to
reversibly couple with the driver shaft via a coupling mechanism.
In an embodiment, the coupling mechanism comprises one or more
threaded components. In an embodiment, one or more of the surgical
screw driver, the driver shaft, and the handle are disposable. In
an embodiment, the handle comprises a polymer or plastic. In an
embodiment, the second torque limiting element is positioned so as
to engage the first torque limiting element in a side by side
fashion when the driver shaft is coupled with the handle. In an
embodiment, the first torque limiting element is configured to bend
in response to a pressure applied to the first torque limiting
element by the second torque limiting element when the threshold
torque is applied to the handle causing the first torque limiting
element to disengage from the second torque limiting element. In an
embodiment, the threshold torque comprises 90 inch pounds (10 N.m.)
of torque. In an embodiment, the handle comprises a third torque
limiting element within the hollow interior, and wherein the first
torque limiting element on the handle is positioned between the
second and third torque limiting elements when the handle is
coupled with the driver shaft. In an embodiment, the first and the
third torque limiting elements are configured to disengage when a
torque above a second threshold torque is applied to the handle
when the handle is rotated in a counter-clockwise direction.
[0014] Described herein is A method for limiting the amount of
torque delivered to a surgical screw, comprising providing to a
user a surgical screw driver with a torque limiting mechanism
comprising a handle configured to couple with and rotate about a
driver shaft, and further comprising two or more torque limiting
elements that engage so that they together create a resistance to
clockwise rotation of the handle about the driver shaft when the
driver shaft is engaged with a surgical screw head of the surgical
screw, until the user applies a torque above a first threshold
torque to the handle in a clockwise direction that causes the two
or more torque limiting elements to disengage so that the torque
above the first threshold torque is not applied to the surgical
screw head. In an embodiment, the driver shaft has a length of 30
cm. In an embodiment, the first torque limiting element comprises a
leaflet comprising a first and a second portion, wherein the first
portion is substantially rectangular and is positioned
substantially perpendicular to the driver shaft, and wherein the
second portion is substantially rectangular and further comprises a
rounded lip at its distal end. In an embodiment, the two or more
components comprise torque limiting elements, and wherein at least
one torque limiting element is positioned on the driver shaft and
at least one torque limiting element is positioned on the handle.
In an embodiment, at least one of the one or more torque limiting
elements comprises an elbow bend comprising an angle of 90. In an
embodiment, at least one torque limiting element on the driver
shaft comprises a polymer or plastic. In an embodiment, a handle is
configured to reversibly couple with the surgical screw driver via
a coupling mechanism. In an embodiment, a coupling mechanism
comprises one or more threaded components. In an embodiment, one or
more of the surgical screw driver, the driver shaft, and the handle
are disposable. In an embodiment, the handle comprises a polymer or
plastic. In an embodiment, the one or more torque limiting element
on the handle is positioned so as to engage the first torque
limiting element in a side by side fashion when the driver shaft is
coupled with the handle. In an embodiment, at least one of the two
or more torque limiting elements is configured to bend in response
to a pressure applied to the at least one of the two or more torque
limiting elements when the threshold torque is applied to the
handle causing the at two or more torque limiting elements to
disengage. In an embodiment, the threshold torque comprises 90 inch
pounds of torque. In an embodiment, the method further comprises
replacing one or more of the drive shaft and the handle. The method
of claim 16, wherein the two or more torque limiting elements
comprise a first and a second torque limiting elements, and wherein
the first torque limiting element is positioned on the driver shaft
and the second torque limiting element is positioned on the handle.
In an embodiment, the method further comprises a third torque
limiting element. In an embodiment, the third torque limiting
element is configured to together create a resistance to
counter-clockwise rotation of the handle about the driver shaft
when the driver shaft is engaged with a surgical screw head of the
surgical screw, until the user applies a torque above a second
threshold torque to the handle in a counter-clockwise direction
that causes the two or more torque limiting elements to disengage
so that the torque above the threshold torque is not applied to the
surgical screw head.
[0015] Described herein is a method for adjusting the amount of
torque applied by a torque limiting surgical screw driver,
comprising providing to a user a torque limiting surgical screw
driver comprising a plurality of torque limiting elements
configured to engage one another and a user controllable torque
adjusting mechanism, wherein the user controllable torque adjusting
mechanism is configured to cause one or more torque limiting
elements of the plurality of torque limiting elements to reposition
relative to one on or more torque limiting elements of the
plurality of torque limiting elements so that a surface area over
which the plurality of torque limiting elements engage is either
increased or decreased. In an embodiment, the user controllable
torque adjusting mechanism comprises a threaded piece. In an
embodiment, the user controllable torque adjusting mechanism
comprises a slideable switch. In an embodiment, the user
controllable torque adjusting mechanism is configured to modify a
resistance to a torque applied to the torque limiting surgical
screw driver. In an embodiment, the resistance to a torque applied
to the torque limiting surgical screw driver is modified by up to
10 inch pounds of torque.
INCORPORATION BY REFERENCE
[0016] All publications, patents, and patent applications mentioned
in this specification are herein incorporated by reference to the
same extent as if each individual publication, patent, or patent
application was specifically and individually indicated to be
incorporated by reference.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] The novel features of the subject matter described herein
are set forth with particularity in the appended claims. A better
understanding of the features and advantages of the present subject
matter will be obtained by reference to the following detailed
description that sets forth illustrative embodiments, in which the
principles of the subject matter described herein are utilized, and
the accompanying drawings of which:
[0018] FIG. 1A shows an oblique view of an embodiment of a torque
limiting surgical screw driver as described herein.
[0019] FIG. 1B shows an embodiment of a driver shaft and torque
limiting unit as described herein.
[0020] FIG. 2 shows a cross-sectional view of an embodiment of a
torque limiting surgical screw driver as described herein.
[0021] FIG. 3 shows a top view of an embodiment of a torque
limiting surgical screw driver as described herein.
[0022] FIG. 4 shows a cross-sectional view of an embodiment of a
torque limiting surgical screw driver as described herein.
[0023] FIGS. 5A-5B show cross-sectional views of an embodiment
handle as described herein.
[0024] FIGS. 6A-6B show a cross-section of an embodiment of the
torque limiting surgical screw driver as described herein.
[0025] FIGS. 7A-7B show cross-sectional views of an embodiment of a
handle together with a cross sectional view of an embodiment of a
moveable mold as described herein.
[0026] FIGS. 8A-8B show cross-sectional views of an embodiment of a
user adjustable torque limiting surgical screw driver as described
herein.
DETAILED DESCRIPTION
[0027] Described herein are devices, systems, and methods for
limiting a torque applied to a screw being placed through a bone as
part of an orthopedic or neurosurgical procedure. Before explaining
at least one embodiment of the inventive concepts disclosed herein
in detail, it is to be understood that the inventive concepts are
not limited in their application to the details of construction,
experiments, exemplary data, and/or the arrangement of the
components set forth in the following description, or illustrated
in the drawings. The presently disclosed and claimed inventive
concepts are capable of other embodiments or of being practiced or
carried out in various ways. Also, it is to be understood that the
phraseology and terminology employed herein is for purpose of
description only and should not be regarded as limiting in any
way.
[0028] In the following detailed description of embodiments of the
described subject matter, numerous specific details are set forth
in order to provide a more thorough understanding of the inventive
concepts. However, it will be apparent to one of ordinary skill in
the art that the inventive concepts within the disclosure may be
practiced without these specific details. In other instances,
well-known features have not been described in detail to avoid
unnecessarily complicating the instant disclosure.
[0029] Further, unless expressly stated to the contrary, "or"
refers to an inclusive or and not an exclusive or. For example, a
condition A or B is satisfied by any one of the following: A is
true (or present) and B is false (or not present), A is false (or
not present) and B is true (or present), and both A and B are true
(or present).
[0030] In addition, use of the "a" or "an" are employed to describe
elements and components of the embodiments herein. This is done
merely for convenience and to give a general sense of the inventive
concepts. This description should be read to include one or at
least one and the singular also includes the plural unless it is
obvious that it is meant otherwise.
[0031] The term "subject" as used herein may refer to a human
subject or any animal subject.
[0032] Finally, as used herein, any reference to "one embodiment"
or "an embodiment" means that a particular element, feature,
structure, or characteristic described in connection with the
embodiment is included in at least one embodiment. The appearances
of the phrase "in one embodiment" in various places in the
specification are not necessarily all referring to the same
embodiment.
[0033] Described herein are methods and devices for limiting the
amount of torque applied to a screw. For example, a pedicle screw
used in a vertebral fixation surgery may fracture the vertebrae
through which it is placed if too much torque is applied to the
pedicle screw or the tulip while the pedicle screw or tulip is
fixed in positon. It should be understood that the methods and
devices described herein are also suitable for use in other
orthopedic and neurosurgical procedures wherein a screw is placed
in or through a bone. For example, the methods and devices
described herein are not limited for use with spinal fixation
procedures but are also useful with, for example, various internal
and external bone fixation devices.
[0034] In an embodiment, a torque limiting surgical screw driver
comprises a handle and a driver shaft.
[0035] A handle may have various hand grips, wherein a grip
comprises a portion of the handle that is configured to be grasped
by a user, for example, during the use of the device by the user.
In an embodiment, a handle comprises a tubular structure with a
grip along its outside surface. In an embodiment, a handle has a
T-grip that comprises two handle arms that are essentially
perpendicular to the driver shaft. In an embodiment, a grip may
comprise two or more handle arms that extend outward and away from
the driver shaft. In an embodiment, a handle grip comprises a
single arm. In an embodiment, one or more handle arms are
reversibly coupleable with a handle. A handle arm may extend
outward and away from the driver shaft for a length comprising
about 4 cm. A handle arm may extend outward and away from the
driver shaft for a length comprising about 3.5 cm. A handle arm may
extend outward and away from the driver shaft for a length
comprising about 3 cm. A handle arm may extend outward and away
from the driver shaft for a length comprising about 2.5 cm. In an
embodiment, a handle arm comprises a single piece (as shown in
FIGS. 6A-6B) that projects away from the handle and may be, for
example, positioned essentially perpendicular to the handle.
[0036] In an embodiment a handle comprises a metal such as, for
example, steel or titanium. In an embodiment, a handle comprises a
hard polymer or a plastic. Hard polymers or plastics may be
injection molded.
[0037] In an embodiment, a handle has a hollow interior and an
opening to receive a driver shaft. The hollow interior may be
continuous with the opening for the driver shaft. A portion of the
driver shaft may be positioned within the hollow interior of the
handle.
[0038] In an embodiment, a driver shaft comprises a rod configured
to engage a surgical screw, for example, a pedicle screw or a
setscrew that couples with a tulip. A driver shaft may comprise
metal, such as, for example, steel or titanium, a polymer, or a
hard plastic, wherein a hard polymer or plastic may be machine
molded. A pedicle screw is a screw configured to be passed through
a pedicle of a vertebra and into the vertebral body to fix two or
more vertebrae together. A, tulip as is it is known in the art,
comprises an articulating head of a pedicle screw that is
configured to receive and fasten a rod. A tulip may be fixed in
place with a setscrew that couples with the head of a tulip, and,
for example, fixes a rod against a saddle within the tulip.
[0039] A distal end of a driver shaft may be configured to engage
directly with a surgical screw head, a pedicle screw head, a tulip,
or a tulip screw head so that the driver shaft may transfer an
applied torque to any of the pedicle screws, tulip, or tulip screws
as would a common screw driver.
[0040] A proximal end of a driver shaft is configured to couple
with a handle as described herein.
[0041] In an embodiment, a length of a driver shaft may be
configured to stabilize the driver when engaged with one of the
pedicle screw, tulip, or setscrew while allowing for efficient
delivery of torque. That is, typically, there exists a length or
range of lengths of a driver shaft at which the driver is stable
while engaged to a screw and torque is efficiently delivered to the
screw. For example, a driver shaft that is too long is likely less
stable when engaged with a screw, and, for example, a driver shaft
that is too short will likely lead to less efficient delivery of
torque to the screw. In an embodiment, a driver shaft may have a
length of 40 cm. In an embodiment, a driver shaft may have a length
of 39 cm. In an embodiment, a driver shaft may have a length of 38
cm. In an embodiment, a driver shaft may have a length of 37 cm. In
an embodiment, a driver shaft may have a length of 36 cm. In an
embodiment, a driver shaft may have a length of 35 cm. In an
embodiment, a driver shaft may have a length of 34 cm. In an
embodiment, a driver shaft may have a length of 33 cm. In an
embodiment, a driver shaft may have a length of 32 cm. In an
embodiment, a driver shaft may have a length of 31 cm. In an
embodiment, a driver shaft may have a length of 30 cm. In an
embodiment, a driver shaft may have a length of 29 cm. In an
embodiment, a driver shaft may have a length of 28 cm. In an
embodiment, a driver shaft may have a length of 27 cm. In an
embodiment, a driver shaft may have a length of 26 cm. In an
embodiment, a driver shaft may have a length of 25 cm. In an
embodiment, a driver shaft may have a length of 24 cm. In an
embodiment, a driver shaft may have a length of 23 cm. In an
embodiment, a driver shaft may have a length of 22 cm. In an
embodiment, a driver shaft may have a length of 21 cm. In an
embodiment, a driver shaft may have a length of 20 cm. In an
embodiment, a driver shaft may have a length of 19 cm. In an
embodiment, a driver shaft may have a length of 18 cm. In an
embodiment, a driver shaft may have a length of 17 cm. In an
embodiment, a driver shaft may have a length of 16 cm. In an
embodiment, a driver shaft may have a length of 15 cm. In an
embodiment, a driver shaft may have a length of 14 cm. In an
embodiment, a driver shaft may have a length of 13 cm. In an
embodiment, a driver shaft may have a length of 12 cm. In an
embodiment, a driver shaft may have a length of 11 cm. In an
embodiment, a driver shaft may have a length of 10 cm. In an
embodiment, a driver shaft may have a length of 9 cm. In an
embodiment, a driver shaft may have a length of 8 cm. In an
embodiment, a driver shaft may have a length of 7 cm. In an
embodiment, a driver shaft may have a length of 6 cm. In an
embodiment, a driver shaft may have a length of 5 cm.
[0042] In an embodiment, a ratio of the length of a handle along
its grip relative to the length of the driver shaft may be
configured to stabilize the driver when engaged with one of the
pedicle screw, tulip, or tulip screw while allowing for efficient
delivery of torque. That is, typically there exists a ratio of the
length of a handle grip to the length of a driver shaft at which
the driver is stable while engaged to a screw and torque is
efficiently delivered to the screw. In an embodiment, a ratio of
the length of the handle relative to the length of the driver shaft
may be, for example, about 1:7. In an embodiment, a ratio of the
length of the handle relative to the length of the driver shaft may
be, for example, about 1:6. In an embodiment, a ratio of the length
of the handle relative to the length of the driver shaft may be,
for example, about 1:5. In an embodiment, a ratio of the length of
the handle relative to the length of the driver shaft may be, for
example, about 1:4. In an embodiment, a ratio of the length of the
handle relative to the length of the driver shaft may be, for
example, about 1:3. In an embodiment, a ratio of the length of the
handle relative to the length of the driver shaft may be, for
example, about 1:2. In an embodiment, a ratio of the length of the
handle relative to the length of the driver shaft may be, for
example, about 1:1.
[0043] In an embodiment, surgical screw driver comprises a handle
rotatably coupled with a driver shaft. That is, in this embodiment,
the handle is configured to rotate about the driver shaft. The
handle may be fixed to the driver shaft, by for example, a screw or
pin passing through the handle into the driver shaft in the axis of
rotation of the handle. Alternatively or additionally, the handle
may be configured to reversibly couple with the driver shaft. In an
embodiment, the handle and driver shaft may be configured to
reversibly couple so that a handle may be used with multiple
interchangeable driver shafts, and a driver shaft may be used with
multiple interchangeable handles.
[0044] In an embodiment, a handle may rotatably couple with a
driver shaft without attaching directly to the driver shaft. In
this embodiment, a proximal end of a driver shaft may be wider than
the rest of the driver shaft. In this embodiment, a handle may be
coupled to the wide proximal end of the driver shift by being
fitted around the wide proximal end of the driver shaft. In this
embodiment, when the handle is positioned around the wide proximal
end of the driver shaft, the wide proximal end of the driver shaft
is positioned within a hollow interior portion of the handle. The
handle further comprises an opening that is large enough in
diameter for the narrow portion of the shaft to fit through but not
wide enough for the wide proximal portion of the driver shaft to
fit through. Thus, in this embodiment, the wide proximal portion of
the drive shaft is unable to slide out through the opening in the
handle. In an embodiment, a handle comprises two or more pieces and
the handle is thus fitted around a wide proximal portion of a
driver shaft by fitting the two or more pieces together that form
the handle around the wide proximal portion of the driver shaft. In
an embodiment, two or more pieces that form a handle may be
interlocking. In an embodiment, two or more pieces that form a
handle may be reversibly couplable so that a handle may, for
example, be coupled with different driver shafts.
[0045] In an embodiment, a surgical screw driver comprises a torque
limiting mechanism. In an embodiment, a torque limiting mechanism
prevents the transmission of torque to a screw when a torque above
a certain threshold is applied by a user to a torque limiting
surgical screw driver. In an embodiment, a torque limiting
mechanism may comprise one or more torque limiting elements
positioned on a driver shaft and one or more corresponding torque
limiting elements positioned on the handle. In an embodiment, one
or more torque limiting element positioned on a handle are
positioned either inside the interior of the handle, on the opening
of the handle, or positioned on both the opening and within the
hollow portion of the handle. In an embodiment, when the torque
limiting element of the driver shaft and the torque limiting
element of the handle are not coupled together or otherwise
engaged, the handle is freely rotatable around the driver shaft.
When the torque limiting elements are coupled together or otherwise
engaged, the handle is prevented from rotating, and a torque that
is applied to the handle is transferred to the driver shaft, and
may in turn be transferred to a surgical screw such as, for
example, a pedicle screw, tulip, or tulip screw.
[0046] In an embodiment, a torque limiting mechanism decouples or
disengages one or more torque limiting elements once a torque above
a certain limit is delivered to the handle by a user, so that the
handle is freed to rotate around the driver shaft and does not
transmit torque to the driver shaft. The torque limiting mechanism
may be configured, so that it decouples or disengages one or more
torque limiting elements when a torque is delivered to the handle
that would transmit a torque to the pedicle screw, tulip, or tulip
screw that exceeds a torque that is safe to deliver to a pedicle
screw, tulip, or tulip screw. Thus, the torque liming mechanism may
be configured to prevent excess torque from being delivered through
the driver to a pedicle, tulip, or tulip screw by decoupling once
an excess torque is delivered.
[0047] In an embodiment, a coupling mechanism comprises one or more
torque limiting elements positioned on the handle and one or more
torque limiting elements positioned on the proximal end of the
driver shaft. The torque limiting element on the handle may be
inside of the handle, along the handle opening, or along both the
handle interior and opening. The torque limiting elements may, for
example, comprise the same material as either the handle or driver
shaft or a different material. In an embodiment, one or more torque
limiting elements are shaped so that they couple or engage one
another by pressing against each other. That is, in an embodiment,
a proximal end of a driver shaft extends into a hollow interior of
a handle so that torque limiting elements on the proximal portion
of the driver shaft are positioned side by side against torque
limiting elements on and/or inside the handle. When a torque is
applied to the handle, the side-by-side torque limiting elements
are pressed against each other and resist rotation of the handle
around the driver shaft. When, however, a torque is applied above a
certain threshold of force either the torque limiting element on
the driver shaft, the torque limiting element on and/or inside the
handle, or both the torque limiting element on and/or inside the
handle and the torque limiting element on the driver shaft may
become distorted so that the two torque limiting elements are no
longer pressed against each other but instead move by each other,
thusly becoming decoupled or disengaged.
[0048] In an embodiment, a torque limiting element comprises a
rectangular shape and protrudes out similar to a wing or flap. In
an embodiment, a torque limiting element comprises a globular
shape. In an embodiment, a torque limiting element comprises a
hook. It should be understand that numerous shapes and structures
are suitable for use with the devices and methods described
herein.
[0049] In an embodiment, a torque limiting element is L-shaped. An
L-shaped torque limiting element may be essentially rectangular in
shape and have a bend along its protruding length that forms and
L-shape. It should be understood that the point along the length of
the torque limiting element wherein the bend is positioned may vary
to any degree and still be suitable for the devices and methods
described herein. Likewise, the angle of the bend may vary and may,
for example, be about 90 degrees. The angle of the bend of the
L-shaped torque limiting element may, for example, be any angle
less than 90 degrees. The angle of the L-shaped torque limiting
element may, for example, be any angle greater than 90 degrees.
[0050] In an embodiment multiple torque limiting elements are
positioned on a proximal end of a driver shaft and are all
L-shaped. The driver shaft couples with a handle that has a
matching number of torque limiting elements that are configured to
couple or engage with the L-shaped torque limiting elements on the
proximal end of the driver shaft. When the L-shaped torque limiting
elements on the proximal end of the driver shaft couple or engage
with the torque limiting elements on the handle the ends of the
L-shaped torque limiting elements rest against the torque limiting
elements of the handle. When the driver shaft is engaged with a
pedicle screw, tulip, or tulip screw and a torque is applied to the
handle that is below a certain threshold, the L-shaped torque
limiting elements press against the handle torque limiting elements
so that the torque applied to the handle is transmitted to the
driver shaft and then to the pedicle, tulip, or tulip screw. In an
embodiment, when the torque applied to the handle exceeds the
certain threshold, the L-shaped torque limiting elements distort so
that the angle at the elbow increases straightening the multiple
L-shaped torque limiting elements and allowing them to move over
and around the handle torque limiting elements, so that the handle
rotates freely over a distance between two adjacent torque limiting
elements. One the handle rotates freely, the excess torque that was
applied cannot be transmitted.
[0051] In an embodiment, a coupling mechanism comprises
interlocking torque limiting elements. In an embodiment,
interlocking torque limiting elements comprise one or more magnets.
That is, a locking mechanism may comprise two magnets, or one
magnet and one metal piece that is configured to magnetically
couple to the magnet. In an embodiment, interlocking torque
limiting elements slidably interlock, and may, for example,
comprise a torque limiting element having a male torque limiting
element that slidably couples with a torque limiting element having
a female torque limiting element. An interlocking torque limiting
element may be configured to decouple when a torque above a certain
threshold is applied to the handle as described herein.
[0052] In an embodiment, a coupling mechanism may comprise two or
more torque limiting elements. A coupling mechanism may, for
example, couple together torque limiting elements that are not in a
one to one correspondence with each other. For example, a single
torque limiting element on and/or inside the handle may couple or
engage simultaneously with two or more torque limiting elements on
the driver shaft.
[0053] In an embodiment, a plurality of torque limiting elements on
and/or inside a handle are in a one to one relationship with a
plurality of torque limiting elements on a driver shaft. In an
embodiment, a plurality of torque limiting elements on and/or
inside a handle are not in a one to one relationship with a
plurality of torque limiting elements on a driver shaft.
[0054] In an embodiment, the type of torque limiting element on
and/or inside the handle may be of the same type as the torque
limiting element on the driver shaft. For example, a rectangular
shaped torque limiting element may couple or engage with a
rectangular shaped torque limiting element on and/or inside the
handle. In an embodiment, the type of torque limiting element on
and/or inside the handle may not be of the same type as the torque
limiting element on the driver shaft. For example, a rectangular
shaped torque limiting element on and/or inside the handle may
couple or engage with a globular shaped torque limiting element on
the proximal end of the driver shaft. Likewise, a combination of
different types of coupling mechanisms may be used. For example, a
coupling mechanism comprising two magnets may be used together with
a coupling mechanism comprising two hooks.
[0055] Typically, one or more torque limiting mechanisms may be
used with any of the devices and methods described herein each
comprising of one or more torque limiting elements. Typically, the,
for example, shape, configuration, material, and number of torque
limiting elements are selected to apply a certain resistance that
is overcome by a torque greater than the pre-determined resistance
that is applied. Other factors that affect torque including, for
example, the shape and resistance to rotation of the handle are
typically accounted for as well when configuring the one or more
torque limiting elements of the one or more torque limiting
mechanisms.
[0056] In an embodiment, a torque limiting surgical screw driver
may be configured to prevent the application of a torque above a
specific set threshold. In an embodiment, a specific set threshold
torque is determined by the properties of the materials chosen to
use for make the torque limiting elements. In an embodiment, a
specific set threshold torque is determined by the number of torque
limiting elements. In an embodiment, a specific set threshold
torque is determined by size of the torque limiting elements. In an
embodiment, a specific set threshold torque is determined by the
physical properties of torque limiting elements. In an embodiment,
a specific set threshold torque is determined and set by a user. In
an embodiment, a specific set threshold torque comprises 115 inch
pounds. In an embodiment, a specific set threshold torque comprises
110 inch pounds. In an embodiment, a specific set threshold torque
comprises 105 inch pounds. In an embodiment, a specific set
threshold torque comprises 100 inch pounds. In an embodiment, a
specific set threshold torque comprises 95 inch pounds. In an
embodiment, a specific set threshold torque comprises 90 inch
pounds. In an embodiment, a specific set threshold torque comprises
85 inch pounds. In an embodiment, a specific set threshold torque
comprises 80 inch pounds. In an embodiment, a specific set
threshold torque comprises 75 inch pounds. In an embodiment, a
specific set threshold torque comprises 70 inch pounds.
[0057] In an embodiment, a torque limiting surgical screw driver is
configured so that a set torque is manually determined or adjusted
by a user. In an embodiment, one or more torque limiting elements
on either a handle or a driver shaft may be repositioned so that
more or less of the surface area of the one or more torque limiting
elements contact one another when the respective elements engage.
For example, in an embodiment, wherein a torque limiting element on
a handle engages with a torque limiting element on a driver shaft
in, for example, a side-by-side fashion, a decrease in the amount
of surface area over which the two torque limiting elements contact
will decrease the amount of torque required to cause the two torque
limiting elements to disengage. For example, in an embodiment,
wherein a torque limiting element on a handle engages with a torque
limiting element on a driver shaft in, for example, a side-by-side
fashion, an increase in the amount of surface area over which the
two torque limiting elements contact will increase the amount of
torque required to cause the two torque limiting elements to
disengage. That is, an increase in the amount of surface area over
which two or more torque limiting elements engage with each other
will typically increase the amount of torque that is necessary to
apply in order to disengage the two or more torque limiting
elements. A decrease in the amount of surface area over which two
or more torque limiting elements engage with each other will
typically decrease the amount of torque that is necessary to apply
in order to disengage the two or more torque limiting elements. In
an embodiment, an amount of surface area over which two or more
torque limiting elements engage may be adjusted by a user by a
mechanism that, for example, repositions one or more torque
limiting elements relative to a one or more other torque limiting
elements. For example, in an embodiment, a torque limiting surgical
screw driver comprises a driver shaft that is configured to move in
and out relative to an opening within a handle. That is, in an
embodiment, a mechanism is configured to controllably cause a
driver shaft to move in and out relative to a handle to which the
driver shaft is coupled. In an embodiment, a manual control is
positioned on the handle that when activated by a user causes the
driver shaft to either advance out of the interior of the handle or
advance in towards the interior of the handle so that one or more
torque limiting elements positioned on the driver shaft are
repositioned relative to one or more torque limiting elements
positioned on the handle. In an embodiment, a user controllable
torque adjusting mechanism comprises a threaded piece functionally
coupled to the driver shaft. When the threaded piece is turned by
the user the driver shaft is either advanced in or out of the
interior of the handle. In an embodiment, the threaded piece itself
is advanced or withdrawn relative to the driver shaft when it is
turned. In an embodiment, the threaded piece is positioned on top
of the handle. In an embodiment, a user controllable torque
adjusting mechanism comprises a slideable switch that is
functionally coupled to the driver shaft. In an embodiment, when a
slideable switch is slid up or down on a track it causes a driver
shaft to advance in or out relative to an interior of a handle to
which it is coupled. In an embodiment, a user controllable torque
adjusting mechanism is configured to cause the repositioning of one
or more torque limiting elements in a fashion that causes a
predictable adjustment in the amount of torque required to
disengage two or more torque limiting elements. For example in an
embodiment, a user controllable torque adjusting mechanism is
configured to modify the amount of torque necessary to disengage
two or more torque limiting elements by up to 30 or more inch
pounds. For example in an embodiment, a user controllable torque
adjusting mechanism is configured to modify the amount of torque
necessary to disengage two or more torque limiting elements by up
to 20 or more inch pounds. For example in an embodiment, a user
controllable torque adjusting mechanism is configured to modify the
amount of torque necessary to disengage two or more torque limiting
elements by up to 15 or more inch pounds. For example in an
embodiment, a user controllable torque adjusting mechanism is
configured to modify the amount of torque necessary to disengage
two or more torque limiting elements by up to 14 or more inch
pounds. For example in an embodiment, a user controllable torque
adjusting mechanism is configured to modify the amount of torque
necessary to disengage two or more torque limiting elements by up
to 13 or more inch pounds. For example in an embodiment, a user
controllable torque adjusting mechanism is configured to modify the
amount of torque necessary to disengage two or more torque limiting
elements by up to 12 or more inch pounds. For example in an
embodiment, a user controllable torque adjusting mechanism is
configured to modify the amount of torque necessary to disengage
two or more torque limiting elements by up to 11 or more inch
pounds. For example in an embodiment, a user controllable torque
adjusting mechanism is configured to modify the amount of torque
necessary to disengage two or more torque limiting elements by up
to 10 or more inch pounds. For example in an embodiment, a user
controllable torque adjusting mechanism is configured to modify the
amount of torque necessary to disengage two or more torque limiting
elements by up to 9 or more inch pounds. For example in an
embodiment, a user controllable torque adjusting mechanism is
configured to modify the amount of torque necessary to disengage
two or more torque limiting elements by up to 8 or more inch
pounds. For example in an embodiment, a user controllable torque
adjusting mechanism is configured to modify the amount of torque
necessary to disengage two or more torque limiting elements by up
to 7 or more inch pounds. For example in an embodiment, a user
controllable torque adjusting mechanism is configured to modify the
amount of torque necessary to disengage two or more torque limiting
elements by up to 6 or more inch pounds. For example in an
embodiment, a user controllable torque adjusting mechanism is
configured to modify the amount of torque necessary to disengage
two or more torque limiting elements by up to 5 or more inch
pounds. For example in an embodiment, a user controllable torque
adjusting mechanism is configured to modify the amount of torque
necessary to disengage two or more torque limiting elements by up
to 4 or more inch pounds. For example in an embodiment, a user
controllable torque adjusting mechanism is configured to modify the
amount of torque necessary to disengage two or more torque limiting
elements by up to 3 or more inch pounds. For example in an
embodiment, a user controllable torque adjusting mechanism is
configured to modify the amount of torque necessary to disengage
two or more torque limiting elements by up to 2 or more inch
pounds. For example in an embodiment, a user controllable torque
adjusting mechanism is configured to modify the amount of torque
necessary to disengage two or more torque limiting elements by up
to 1 or more inch pounds. In an embodiment, a user controllable
torque adjusting mechanism is configured to modify the amount of
torque necessary to disengage two or more torque limiting elements
by increments of 5 or more inch pounds. In an embodiment, a user
controllable torque adjusting mechanism is configured to modify the
amount of torque necessary to disengage two or more torque limiting
elements by increments of 2 or more inch pounds. In an embodiment,
a user controllable torque adjusting mechanism is configured to
modify the amount of torque necessary to disengage two or more
torque limiting elements by increments of 1 or more inch
pounds.
[0058] FIG. 1A shows an oblique view of an embodiment of a torque
limiting surgical screw driver. In the shown embodiment, a torque
limiting surgical screw driver comprises a driver shaft 102 which
is rotatably coupled to a handle 104. A driver shaft 102 may
comprise a distal portion that comprises a driver shaft tip 112
configured to engage with a screw, and a proximal portion that
comprises four torque limiting elements 106a, 106b, 106c, 106d. In
this embodiment, torque limiting elements 106a, 106b, 106c, and
106d comprise leaflets that project out of a torque limiting unit
114 which in turn couples with the driver shaft 102. In this
embodiment, the torque limiting unit 114 comprises a hole through
which the driver shaft 102 passes. Having torque limiting elements
106a, 106b, 106c, and 106d comprise a torque limiting unit 114
which couples with the driver shaft 102 is advantageous, for
example, in that the torque limiting unit 114 and torque limiting
elements 106a, 106b, 106c, and 106d may comprise a different
material than the driver shaft. In an embodiment, manufacture of
the torque limiting surgical screw driver described herein
comprises over-molding the torque limiting unit 114 around the
driver shaft 102, thus permanently binding together the driver
shaft 102 and the torque limiting unit 114. Torque limiting
elements 106a, 106b, 106c, and 106d may comprise a relatively
bendable material such as a polymer and the driver shaft 102 may
comprise a harder material such as a metal, for example, steel. In
an embodiment (not shown), torque limiting elements 106a, 106b,
106c, and 106d are attached directly to the driver shaft 102 and
project directly from the driver shaft 102. In the shown
embodiment, the torque limiting unit 114 is affixed to the driver
shaft 102, so that the torque limiting unit 114 and attached torque
limiting elements 106a, 106b, 106c, and 106d do not rotate around
the driver shaft 102. In the shown embodiment, each of the torque
limiting elements 106a, 106b, 106c, and 106d positioned on the
driver shaft 102 comprise an elbow 108. In an embodiment, each of
the torque limiting elements 106a, 106b, 106c, and 106d are
configured to bend at an elbow 108. In an embodiment, each of the
torque limiting elements 106a, 106b, 106c, and 106d on the driver
shaft 102 comprise an edge 116 that is rounded and is configured to
engage a torque limiting element on the handle 104. In an
embodiment, edge 116 functions similar to a cam follower, wherein
when torque is applied to a torque limiting element on a handle,
the torque limiting element on the handle functions similar to a
cam leader, in that it is configured to rotatationally displace
edge 116 similar to a displacement of a cam follower by a cam
leader. In an embodiment, the torque limiting elements 106a, 106b,
106c, and 106d on the driver shaft 102 extend along at least a
portion of the interior of the handle 104. In an embodiment, the
torque limiting elements 106a, 106b, 106c, and 106d on the driver
shaft 102 extend along the entire interior of the handle 104. A
handle 104 may comprise a T-grip which comprises two handle arms
110a and 110b. A handle may further comprise eight torque limiting
elements (only six are shown in FIG. 1A) 106e, 106f, 106g, 106h,
106i, 106j that are positioned along the length of at least a
portion of the hollow interior portion of the handle 104. In an
embodiment, the eight torque limiting elements (only six are shown
in FIG. 1A) 106e, 106f, 106g, 106h, 106i, 106j are extend along the
entire length of the interior of the handle 104. Each of the torque
limiting elements on the handle 106e, 106f, 106g, 106h, 106i, 106j
(two not shown) is separated by a track. The torque limiting
elements 106a, 106b, 106c, and 106d on the driver shaft are
configured to move along the track between the torque limiting
elements on the handle 106e, 106f, 106g, 106h, 106i, 106j when the
handle 104 is rotated about the driver shaft 102. Torque limiting
elements 106e, 106f, 106g, 106h, 106i, 106j on the hollow interior
of the handle engage or couple with the torque limiting elements
106a, 106b, 106c, and 106d on the driver shaft. Any of the torque
limiting elements 106a, 106b, 106c, and 106d on the driver shaft
may couple or engage with any of the torque limiting elements 106e,
106f, 106g, 106h, 106i, 106j (and the two not shown) on the hollow
interior of the handle. When, for example, a torque limiting
element 106a on the driver shaft 102 engages or couples with a
torque limiting element 106e on the handle 104, clockwise rotation
of the handle 104 around the driver shaft 102 is resisted by the
engagement or coupling of the torque limiting elements 106a and
106e. In this embodiment, torque limiting element 106acomprises an
L-shaped torque limiting element that protrudes outward from the
driver shaft and torque limiting element 106e comprises a
ridge-like torque limiting element along the inside of the handle
104, and the tip of torque limiting element 106a presses against
the ridge-like torque limiting torque limiting element 106e when a
torque is applied to the handle 104 and the driver shaft 102 is
held. The driver shaft 102 may be held by, for example, the driver
shaft tip 112 engaging with the head of a screw that is being
advanced through bone. When a torque is applied to handle 104, and
the driver shaft 102 is engaged with a screw head, the torque may
be transferred directly to the driver shaft 102 from the handle
104. The torque delivered to the driver shaft 102 from the handle
may then be transferred from the driver shaft 102 to the screw head
to, for example, drive the screw into a bone. As long as the torque
applied to the handle does not exceed the resistance created by the
engaged torque limiting elements on the driver shaft and handle,
the torque applied to a handle 102 will be transferred to the
driver shaft 104. When the torque applied to a handle 102 exceeds
the resistance created by the engaged torque limiting elements on
the driver shaft and handle, the torque limiting elements will
disengage. When the torque limiting elements on the driver shaft
102 and handle 104 disengage there is no longer any resistance to
rotation of the handle 102 applied by the torque limiting elements,
and the handle 104 rotates around the driver shaft 102 in response
to the applied torque. When the handle 104 rotates around the
driver shaft 102, no torque is transferred to the driver shaft 104,
and no torque is transferred to the screw head. That is, in this
embodiment, when torque limiting elements on the handle 104 and
torque limiting elements on the driver shaft 102 disengage, torque
is not transferred to a screw head by the torque limiting surgical
screw driver. In this embodiment, torque applied to a handle 104 in
a clockwise direction it causes four of the torque limiting
elements 106e, 106f, 106g, 106h, 106i, 106j (and the two not shown)
on the handle 104 to correspondingly engage the four torque
limiting elements 106a, 106b, 106c, and 106d on the driver shaft.
In this embodiment, when a torque that is applied to a handle 104
in a clockwise direction is sufficiently large it causes four of
the torque limiting elements 106e, 106f, 106g, 106h, 106i, 106j
(and the two not shown) on the handle 104 to correspondingly
disengage from the four torque limiting elements 106a, 106b, 106c,
and 106d on the driver shaft to which they had been previously
engaged. In an embodiment, torque limiting elements on the handle
104 and torque limiting elements on the driver shaft 102 disengage,
for example, when a clockwise torque applied to the handle 104
causes the torque limiting elements on the handle 104 to press
against the torque limiting elements on the driver shaft 102 with
sufficient force to cause the torque limiting elements on the
driver shaft to bend at their respective elbows. As the torque
limiting elements become progressively more bent at their
respective elbows due to the pressure applied to them by the torque
limiting elements on the handle, the amount of resistance to
rotation of the handle 104 around the driver shaft 102 decreases.
When the resistance to rotation sufficiently decreases due to
bending of the torque limiting elements on the driver shaft, the
torque limiting elements on the handle 104 rotate past the torque
limiting elements on the driver shaft 102 such that the torque
limiting elements become disengaged and the handle 104 rotates
about the driver shaft 102, until the torque limiting elements on
the handles each respectively encounter another torque limiting
element on the driver shaft 102.
[0059] FIG. 1B shows an embodiment of a driver shaft 102 and torque
limiting unit 114 that are not coupled with a handle. In an
embodiment, a torque limiting unit 114 comprises four leaflets
106a, 106b, 106c, and 106d. In an embodiment, a torque limiting
unit 114 is molded around a driver shaft 102. In an embodiment (not
shown), the four leaflets 106a, 106b, 106c, and 106d may be
individually molded onto a driver shaft 102 and not configured as
part of a torque limiting unit 114. In an embodiment, the four
leaflets 106a, 106b, 106c, and 106d may be continuous with a driver
shaft 102. In an embodiment, the four leaflets 106a, 106b, 106c,
and 106d may comprise the same material as the drier shaft 102. In
an embodiment, the torque limiting unit 114 and four leaflets 106a,
106b, 106c, and 106d may comprise a polymer and the driver shaft
102 may comprise a metal. In an embodiment, protrusions 120 are
configured to couple a driver shaft to a handle. In an embodiment,
a leaflet length 118 may be set for one or more leaflets 106a,
106b, 106c, and 106d during the manufacturing process in order to
provide a particular resistance to a torque. For example,
typically, the longer the leaflet length 118 the greater will be
the resistance provided by the leaflet to an applied torque, and
the shorter the length 118 the lower greater will be the resistance
provided by the leaflet to an applied torque. The relationship of a
leaflet length 118 together with, for example, the material and
shape of a leaflet, to a resistance to particular torque is
predictable, so that the leaflets may be manufactured specifically
to resist a specific torque. As described, in an embodiment, the
surface area of a leaflet engaged with a torque limiting element on
a handle (not shown in FIG. 1B) may be manually adjusted by a user
to modify the resistance to torque of leaflets as well.
[0060] In an embodiment, a leaflet comprises a first portion 122
that is connected to and continuous with a second portion 124. In
an embodiment, a first portion 122 is positioned substantially
perpendicular to the driver shaft 102. In an embodiment, the first
portion 122 is directly attached to a torque limiting unit 114. In
an embodiment, the first portion 122 is directly attached to a
driver shaft 102. In an embodiment, the first portion 122 is
substantially rectangular. In an embodiment, the second portion 124
is substantially rectangular. In an embodiment, the second portion
124 further comprises a rounded lip 126. In an embodiment, the
leaflet further comprises an elbow 128 between the first portion
122 and the second portion 124. In an embodiment, the elbow 128
between the first portion 122 and second portion 124 comprises an
angle less than 20 degrees. In an embodiment, the elbow 128 between
the first portion 122 and second portion 124 comprises an angle
less than 30 degrees. In an embodiment, the elbow 128 between the
first portion 122 and second portion 124 comprises an angle less
than 40 degrees. In an embodiment, the elbow 128 between the first
portion 122 and second portion 124 comprises an angle less than 50
degrees. In an embodiment, the elbow 128 between the first portion
122 and second portion 124 comprises an angle less than 60 degrees.
In an embodiment, the elbow 128 between the first portion 122 and
second portion 124 comprises an angle less than 70 degrees. In an
embodiment, the elbow 128 between the first portion 122 and second
portion 124 comprises an angle less than 80 degrees. In an
embodiment, the elbow 128 between the first portion 122 and second
portion 124 comprises an angle less than 90 degrees. In an
embodiment, the elbow 128 between the first portion 122 and second
portion 124 comprises an angle less than 100 degrees. In an
embodiment, the elbow 128 between the first portion 122 and second
portion 124 comprises an angle less than 110 degrees. In an
embodiment, the elbow 128 between the first portion 122 and second
portion 124 comprises an angle less than 120 degrees.
[0061] In an embodiment, a torque limiting surgical screw driver
may limit the torque that may be applied in both directions of
rotation of the torque limiting surgical screw driver's handle.
That is, in an embodiment, a torque limiting surgical screw driver
may limit the amount of torque that may be applied by a user when
the torque limiting surgical screw driver handle is turned both in
the clockwise as well as counterclockwise direction. In an
embodiment, a torque limiting surgical screw driver limits the
torque applied by a user to a first torque in the clockwise
direction and a second torque in the counter clockwise direction.
In an embodiment, a torque applied to a screw being driven into a
bone by a torque limiting surgical screw driver is limited to a
first torque, and a torque applied to a screw being pulled out
(unscrewed) from a bone is limited to a second torque. In an
embodiment, the torque limited by a torque limiting surgical screw
driver may be limited in both the clockwise and counter clockwise
direction when two torque limiting elements on either the handle or
driver shaft are configured to engage with a single torque limiting
element on either the handle or driver shaft. For example, in an
embodiment, a first and second torque limiting element are
positioned on a handle as described herein and a third torque
limiting element is positioned on a driver shaft. In this
embodiment, the third torque limiting element on the driver shaft
is positioned between the first and second torque limiting elements
on the handle when the handle is coupled with the driver shaft. In
this embodiment, when the handle is turned in a clockwise direction
the third torque limiting element on the driver shaft engages the
second torque limiting element on the handle in a manner as
described herein and when the handle is turned in a counter
clockwise direction the third torque limiting element on the driver
shaft engages the first torque limiting element as described
herein. In an embodiment, the first and second torque limiting
elements on the handle are identical such that they will resist
disengagement from the third torque limiting element on the handle
to the same extent for both clockwise and counter-clockwise
rotation. In an embodiment, the first and second torque limiting
elements on the handle are different and as such are configured to
resist disengagement from the third torque limiting element on the
handle to the same extent for both clockwise and counter-clockwise
rotation. In an embodiment, a single torque limiting element on the
handle is positioned between two torque limiting elements on the
driver shaft when the handle is coupled with driver shaft. In an
embodiment, one or more pairs of torque limiting engagers on either
the handle or the driver shaft are respectively engaged with a
single torque limiting engager on either the handle or the driver
shaft when the handle is coupled with the driver shaft as described
herein.
[0062] FIG. 2 shows a cross-sectional view of an embodiment of a
torque limiting surgical screw driver. In this embodiment, a
central screw saddle 212 is configured to receive either a screw or
pin that will couple a handle 204 to a driver shaft 202. In an
embodiment, when a screw or pin is positioned within central screw
saddle, the handle 204 is rotatably coupled to the driver shaft
202, such that when an sufficient torque is applied to a handle 204
and driver shaft 202 is held in place, the handle 204 may rotate
about the driver shaft 202. Lateral screw saddles 210a and 210b are
configured to receive a screw 208 or rod that secures a cover plate
214 to the torque limiting surgical screw driver. Torque limiting
element 206a is shown in cross-section. In an embodiment, torque
limiting element 206a extends along the length of the handle 204.
Torque limiting element 206a is shown engaged with torque limiting
element 206c. In an embodiment, a torque limiting surgical screw
driver comprises more torque limiting elements on the handle 204
than on the driver shaft 202 such that not all of the torque
limiting elements on the handle 204 are engaged to a torque
limiting element on the driver shaft at any time. For example, FIG.
2 shows torque limiting element 206c on the handle 204 is engaged
with a torque limiting element 206a on a driver shaft 202, and
torque limiting element 206b is not engaged to any torque limiting
elements from the driver shaft 202.
[0063] FIG. 3 shows a top view of an embodiment of a torque
limiting surgical screw driver. In an embodiment, a torque limiting
surgical screw driver includes a screw plate 314, which is
positioned on top of the handle 304 and which may be secured with a
screw 308 that is positioned in a lateral saddle not shown, by
central screw (not shown) that is positioned in central screw
saddle 312, and a lateral screw (not shown) that is positioned in
lateral saddle 310.
[0064] FIG. 4 shows a cross-sectional view of an embodiment of a
torque limiting surgical screw driver. In an embodiment, a torque
limiting element 406a on a driver shaft 402 comprises a top section
416 that is configured to engage a torque limiting element on a
handle 406b, an elbow 408 as described herein, and a bottom portion
414 that is configured to couple with or attach to a driver shaft
402. In an embodiment, a handle 404 comprises a groove 418
configured to receive the top section 416 of the torque limiting
element 406a. The dashed line indicates the direction of rotation
applied to the handle when the torque limiting surgical screw
driver is operated.
[0065] FIGS. 5A-5B show cross-sectional views of a handle 502 and
506. In an embodiment, a torque limiting surgical screw driver may
be manufactured to a set torque limit by, for example, setting the
length of a torque limiting elements along the inside of the handle
504 (in FIG. 5A) and 508 (in FIG. 5B). In an embodiment, torque
limiting elements along the inside of the handle 504 and 508 may be
configured to engage one or more leaflets on a torque limiting unit
that is coupled with the driver shaft, as described herein. Where
the torque limiting elements on the torque limiting unit (e.g.
leaflets) remain the same length, varying the set torque at which
the torque limiting elements on the torque limiting unit will
disengage from the corresponding torque limiting elements on the
inside of the handle 504 and 508 may be achieved during the
manufacture of the device by varying the length of the torque
limiting elements on the inside of the handle 504 and 508.
Typically, relatively longer torque limiting elements on the inside
of the handle 504, as shown in FIG. 5A, will require a relatively
greater amount of torque to disengage the respective torque
limiting elements on the torque limiting unit as compared to the
relatively shorter torque limiting elements on the inside of the
handle 508, as shown in FIG. 5B. Typically, relatively shorter
torque limiting elements 508, as shown in FIG. 5B, will require a
relatively smaller amount of torque to disengage the respective
torque limiting elements on the torque limiting unit 508 as
compared to the longer torque limiting elements on the inside of
the handle 504, as shown in FIG. 5A. In an embodiment, the length
of the torque limiting elements on the torque limiting unit are
modified during manufacture so as to determine the amount of torque
that will cause the torque limiting elements on the torque limiting
unit to disengage from the torque limiting elements on the inside
of the handle 504 and 508. In an embodiment, both the length of the
torque limiting unit and the lengths of the torque limiting
elements on the handle 504 and 508 may both be modified during
manufacture to determine a desired torque at which the respective
elements disengage. Also shown in FIGS. 5A and 5B is an embodiment
of the torque limiting surgical screw driver described herein and
further comprises a snap connector 510 and 512 to facilitate the
connecting of a handle arm (not shown) that snap fits with the snap
fit connector 510 and 512. In an embodiment, a snap-fit connector
510 and 512 comprises an opening in the handle.
[0066] FIGS. 6A-6B show a cross-section of an embodiment of the
torque limiting surgical screw driver 602 and 606 described herein.
Specifically, FIGS. 6A-6B show how a torque limiting unit 604 and
608 comprising one or more torque limiting elements and coupled
with the driver shaft engages with the torque limiting elements on
the handle 610 and 616. As shown, the torque limiting elements on
the handle 610 shown in FIG. 6A are longer than the torque limiting
elements on the handle 616 shown in FIG. 6B, thus, assuming the
torque limiting units were the same length, the torque required to
disengage the respective torque limiting elements is greater in
FIG. 6A than in FIG. 6B. FIGS. 6A-6B also show an embodiment in
which a single handle arm 612 and 614 is coupled with a connector
such as, for example, a snap fit connector on the handle (not
shown). In an embodiment, the handle of the torque limiting
surgical screw driver is configured to couple with a handle arm 612
and 614 that aids a user in applying torque. In an embodiment, the
handle is coupled to the handle arm 612 and 614 by a user. In an
embodiment, a handle arm 612 and 614 reversibly couples with a
handle.
[0067] FIGS. 7A-7B show cross-sectional views of a handle 700 and
706 together with a cross sectional view of a moveable mold 704 and
710. In an embodiment, the torque limiting surgical screw driver
described herein comprises components that are injection molded. In
an embodiment, the torque limiting elements on the inside of the
handle 702 and 708 are molded by the projections and grooves 706
and 712 on a moveable mold 704 and 710. In this embodiment, the
handle 702 and 706 is formed as a hollow essentially cylindrical
shape (shown in cross-section in FIGS. 7A-7B) and a moveable mold
704 and 720, which too is essentially cylindrically shaped (shown
in cross-section in FIGS. 7A-7B), slides into the handle 700 and
706 during manufacture to mold the torque limiting elements on the
inside of the handle 702 and 708. The projections and grooves 706
on the moveable mold 704 shown in FIG. 7A are longer than the
projections and grooves 712 on the moveable mold 710 shown in FIG.
7B. Therefore, the torque limiting elements formed on the inside of
handle 702, shown in FIG. 7A, are longer than the torque limiting
elements on the inside of the handle 708, shown in FIG. 7B. In this
embodiment, the torque that is required to disengage the respective
torque limiting elements on the inside of the handle 702 and 708
and the torque limiting elements on or coupled with the driver
shaft is determined by the length of the projections and grooves
706 and 712 on the moveable 704 and 710.
[0068] FIGS. 8A-8B show cross-sectional views of a user adjustable
torque limiting surgical screw driver. In an embodiment, a user
adjustable torque limiting surgical screw driver comprises a
control knob 810 and 822, wherein the control knob 810 and 822 is
configured to allow a user to adjust a torque limit at which the
torque limiting elements on the torque limiting unit 808 will
disengage from the torque limiting units on the inside of the
handle 804 and 814. In an embodiment, an adjustment knob 810 and
822 is functionally connected to a threaded rod 802 and 822. In an
embodiment, the threaded rod 802 and 820 threadably couples with
threading on the inside 816 of the torque limiting unit 818 as
shown in FIG. 8B. In this embodiment, as a user rotates the
adjustment knob 810 and 822, the threadably coupled torque limiting
unit 808 and 818 is either advanced or withdrawn relative to the
torque limiting elements on the inside of the handle 804 and 814
depending on the direction that the adjustment knob 810 and 820 is
rotated relative to the threading. Typically, as the torque
limiting unit 808 and 820 is advanced down the length of the axis
due to the user rotating the adjustment knob 810 and 822, less of
the surface of the torque limiting elements on the torque limiting
unit 808 and 818 will be in contact (i.e. engaged) with the torque
limiting elements on the inside of the handle 808 and 818. When
less of the surface of the torque limiting elements on the torque
limiting unit 808 and 818 are in contact with the torque limiting
elements on the inside of the handle 804 and 814, a smaller amount
of torque is required to cause the torque limiting elements on the
torque limiting unit 808 and 818 and the torque limiting elements
on the inside of the handle 804 and 814 to disengage. FIG. 8B shows
an embodiment in which the torque limiting unit 818 has been
advanced along the length of the handle so that a smaller amount of
torque is required to cause the torque limiting elements on the
torque limiting unit 808 and 818 and the torque limiting elements
on the inside of the handle 804 and 814 to disengage relative to
the embodiment shown in FIG. 8A. FIG. 8A shows an embodiment in
which the torque limiting unit 818 has been withdrawn into the
handle so that the entire surface of the torque limiting elements
on the torque liming unit 808 and 818, that are configured to
engage with the torque limiting elements on the inside of the
handle 804 and 814, are positioned to engage with the torque
limiting elements on the inside of the handle 804 and 814. In the
embodiment shown in FIG. 8A, a larger amount of torque is required
to cause the torque limiting elements on the torque limiting unit
804 and 814 and the torque limiting elements on the inside of the
handle 804 and 818 to disengage relative to the embodiment shown in
FIG. 8B.
[0069] While preferred embodiments of the systems, devices, and
methods described herein have been shown and described herein, it
will be obvious to those skilled in the art that such embodiments
are provided by way of example only. Numerous variations, changes,
and substitutions will now occur to those skilled in the art
without departing from the subject matter described herein. It
should be understood that various alternatives to the embodiments
of the systems, devices, and methods described herein may be
employed in practicing the systems, devices, and methods described
herein. It is intended that the following claims define the scope
of the invention and that methods and structures within the scope
of these claims and their equivalents be covered thereby.
* * * * *