U.S. patent application number 16/199070 was filed with the patent office on 2020-05-28 for clamping mechanism for a portable x-ray imaging device.
The applicant listed for this patent is Turner Imaging Systems, Inc.. Invention is credited to Douglas P. Hansen, Thomas L. Youd.
Application Number | 20200163636 16/199070 |
Document ID | / |
Family ID | 70770283 |
Filed Date | 2020-05-28 |
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United States Patent
Application |
20200163636 |
Kind Code |
A1 |
Youd; Thomas L. ; et
al. |
May 28, 2020 |
Clamping Mechanism for a Portable X-Ray Imaging Device
Abstract
Clamping mechanisms that assist with the operation of small,
portable x-ray devices are described. A support structure contains
a clamping device for a portable X-ray device having a C-arm and a
bottom containing a cradle configured to abut and support a C-arm
of the portable x-ray device, a mounting plate configured to
support a bottom portion of the portable x-ray device. The mounting
plate has length members with ridges and a width member extending
between the length members, a registration insert configured to
mate with an opening in the portable x-ray device, and two clamps
configured to secure the portable x-ray device to a cradle and the
mounting plate. This clamping device allows the portable x-ray
device to be quickly and easily attached to, and detached from, the
support structure using only a single hand, while simultaneously
preventing the portable x-ray device from accidentally being
removed. Other embodiments are described.
Inventors: |
Youd; Thomas L.; (Salt Lake
City, UT) ; Hansen; Douglas P.; (Spanish Fork,
UT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Turner Imaging Systems, Inc. |
Orem |
UT |
US |
|
|
Family ID: |
70770283 |
Appl. No.: |
16/199070 |
Filed: |
November 23, 2018 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 6/4411 20130101;
A61B 6/4405 20130101; A61B 6/4441 20130101; A61B 6/0407 20130101;
A61B 6/462 20130101 |
International
Class: |
A61B 6/00 20060101
A61B006/00 |
Claims
1. A clamping device for a portable X-ray device having a C-arm and
a bottom, comprising: a cradle configured to abut and support a
C-arm of the portable x-ray device; a mounting plate configured to
support a bottom portion of the portable x-ray device, the mounting
plate having length members with ridges and a width member
extending between the length members; a registration insert
configured to mate with an opening in the portable x-ray device;
and two clamps configured to secure the portable x-ray device to
the cradle and the mounting plate.
2. The device of claim 1, wherein the cradle is connected to a
supporting structure for the portable x-ray device.
3. The device of claim 1, wherein the portable x-ray device is
capable of being removed from the clamping device using a single
hand.
4. The device of claim 1, wherein the mounting plate constrains a
bottom of the portable x-ray device when it abuts the cradle.
5. The device of claim 1, wherein the clamps are located on
opposing sides of the bottom of the portable x-ray device.
6. The device of claim 3, wherein the clamps comprises a release
that can be manually activated by a single hand.
7. The device of claim 6, wherein the release contains a ratchet
mechanism that only partially releases the clamps and fully
releases the clamps using a second activation.
8. The device of claim 1, wherein the clamps contain extensions
that are flexible and compress when secured on the portable x-ray
device.
9. The device of claim 1, wherein the cradle, mounting plate,
registration insert, and/or clamps are configured with rounded
surfaces and smooth corners.
10. An x-ray system, comprising: a portable X-ray device having a
C-arm and a bottom; a supporting structure for the portable X-ray
device; a clamping device comprising: a cradle configured to abut
and support a C-arm of the portable x-ray device; a mounting plate
configured to support a bottom portion of the portable x-ray
device, the mounting plate having length members with ridges and a
width member extending between the length members; a registration
insert configured to mate with an opening in the portable x-ray
device; and two clamps configured to secure the portable x-ray
device to the cradle and the mounting plate.
11. The system of claim 10, wherein the supporting structure
comprising an extension arm.
12. The system of claim 11, wherein the cradle is connected to the
extension arm of the supporting structure.
13. The system of claim 10, wherein the portable x-ray device is
capable of being removed from the clamping device using a single
hand.
14. The system of claim 10, wherein the mounting plate constrains a
bottom of the portable x-ray device when it abuts the cradle.
15. The system of claim 10, wherein the clamps are located on
opposing sides of the bottom of the portable x-ray device.
16. The system of claim 15, wherein the clamps comprises a release
that can be manually activated by a single hand.
17. The system of claim 16, wherein the release contains a ratchet
mechanism that only partially releases the clamps and full releases
the clamps using a second activation.
18. The system of claim 10, wherein the clamps contain extensions
that are flexible and compress when secured on the portable x-ray
device.
19. The system of claim 10, wherein the cradle, mounting plate,
registration insert, and/or clamps are configured with rounded
surfaces and smooth corners.
20. A method of imaging, comprising: attaching a portable x-ray
device having a C-arm and a bottom to a supporting structure with a
single hand using a clamping device comprising: a cradle configured
to abut and support a C-arm of the portable x-ray device; a
mounting plate configured to support a bottom portion of the
portable x-ray device, the mounting plate having length members
with ridges and a width member extending between the length
members; a registration insert configured to mate with an opening
in the portable x-ray device; and two clamps configured to secure
the portable x-ray device to the cradle and the mounting plate;
closing the clamps on the portable x-ray device; and imaging an
object using the portable x-ray device.
21. The method of claim 21, further comprising removing the
portable x-ray device from the supporting device using a single
hand by opening the clamps.
Description
FIELD
[0001] This application relates generally to X-ray equipment. More
specifically, this application relates to clamping mechanisms that
are used to assist with the operation of small, portable x-ray
devices.
BACKGROUND
[0002] X-ray imaging systems typically contain an X-ray source and
an X-ray detector. X-rays (or other types of radiation) is emitted
from the source and impinges on the X-ray detector to provide an
X-ray image of the object or objects that are placed between the
X-ray source and the detector. The X-ray detector is often an image
intensifier or even a flat panel digital detector. In some
configurations, these devices contain a C-arm assembly with the
source and detector on opposite ends of the "C" arm of the
assembly. The C-arm assembly can move through continuous rotation
angles relative to the object in order to acquire images from
multiple orientations.
[0003] Some X-ray imaging systems have limited mobility since they
contain a gantry that is secured to a floor, wall, or ceiling.
Other imaging systems are more portable since they contain a mobile
base (on wheels) and so they can be used in a variety of clinical
environments, such as radiology and surgery departments of a
medical facility. In either case, the gantry or mobile base is
attached to the X-ray imaging device in a permanent or
semi-permanent fashion, such that removing the C-arm from the
supporting assembly is not done routinely and quickly.
SUMMARY
[0004] This application relates generally to clamping mechanisms
that are used to assist with the operation of small, portable x-ray
devices. In particular, this application describes a support
structure with a clamping device for a portable X-ray device having
a C-arm and a bottom which contains a cradle configured to abut and
support a C-arm of the portable x-ray device, a mounting plate
configured to support a bottom portion of the portable x-ray device
wherein the mounting plate has length members with ridges and a
width member extending between the length members, a registration
insert configured to mate with an opening in the portable x-ray
device, and two clamps configured to secure the portable x-ray
device to the cradle and the mounting plate. Using such a clamping
device allows the portable x-ray device to be quickly and easily
attached to, and detached from, the support structure by the
average person using only a single hand, while simultaneously
preventing the portable x-ray device from accidentally being
removed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] The following description can be better understood in light
of the Figures which show various embodiments and configurations of
the X-ray devices.
[0006] FIG. 1 shows a view of some embodiments of small, portable
X-ray devices;
[0007] FIG. 2 shows another view of some embodiments of small,
portable X-ray devices;
[0008] FIGS. 3A and 3B show some embodiments of supporting devices
that can be used with small, portable X-ray devices;
[0009] FIG. 4 shows other embodiments of supporting devices that
can be used with small, portable X-ray devices;
[0010] FIG. 5 illustrates yet other embodiments of a supporting
device for holding small, portable X-ray devices;
[0011] FIG. 6 illustrates some embodiments of a connecting member
for attaching small, portable X-ray devices to a support
structure;
[0012] FIGS. 7-8 shows some embodiments of clamping mechanisms for
attaching small, portable X-ray devices to a support structure;
[0013] FIGS. 9-12 shows some embodiments of opened and closed
clamping mechanisms for attaching small, portable X-ray devices to
a support structure; and
[0014] FIGS. 13-14 show some conventional supporting devices for
x-ray devices.
[0015] Together with the following description, the Figures
demonstrate and explain the principles of the structures, methods,
and systems described herein. In the drawings, the thickness and
size of components may be exaggerated or otherwise modified for
clarity. The same reference numerals in different drawings
represent the same element, and thus their descriptions will not be
repeated. Furthermore, well-known structures, materials, or
operations are not shown or described in detail to avoid obscuring
aspects of the described devices.
DETAILED DESCRIPTION
[0016] The following description supplies specific details in order
to provide a thorough understanding. Nevertheless, the skilled
artisan will understand that the described X-ray devices can be
implemented and used without employing these specific details.
Indeed, the described systems and methods related to X-ray devices
can be placed into practice by modifying the described systems and
methods and can be used in conjunction with any other apparatus and
techniques conventionally used in the industry. For example, while
the description below focuses on clamping mechanisms for C-arm
x-ray devices, the clamping mechanisms can be used with other X-ray
imaging arms and x-ray devices, including U-arms or portable x-ray
devices that are configured to approximate the C-arm
configuration.
[0017] In addition, as the terms on, disposed on, attached to,
connected to, or coupled to, etc. are used herein, one object
(e.g., a material, element, structure, member, etc.) can be on,
disposed on, attached to, connected to, or coupled to another
object--regardless of whether the one object is directly on,
attached, connected, or coupled to the other object or whether
there are one or more intervening objects between the one object
and the other object. Also, directions (e.g., on top of, below,
above, top, bottom, side, up, down, under, over, upper, lower,
lateral, orbital, horizontal, etc.), if provided, are relative and
provided solely by way of example and for ease of illustration and
discussion and not by way of limitation. Where reference is made to
a list of elements (e.g., elements a, b, c), such reference is
intended to include any one of the listed elements by itself, any
combination of less than all of the listed elements, and/or a
combination of all of the listed elements. Furthermore, as used
herein, the terms a, an, and one may each be interchangeable with
the terms at least one and one or more.
[0018] FIG. 1 shows some embodiments of small, portable X-ray
devices 100 that can be attached to and held by the supporting
devices described herein. Generally, the portable X-ray devices 100
contain an imaging arm that allows the system to be used to take
X-ray images of a portion of a patient's body or any other object
capable of being analyzed by x-rays, including animals, industrial
components such as electronic circuit boards, containers to be
inspected, and/or passenger luggage. In some configurations, the
imaging arm is substantially shaped like the letter "C" and is
therefore referred to as a C-shaped support arm (or C-arm) 105. The
C-arm has any size that can be held and operated by hand when in
use, as seen in FIG. 1.
[0019] The C-arm 105 can contain any X-ray source 135 and X-ray
detector 140 that allow the X-ray system 100 to take X-ray images.
The X-ray source 135 can contain any source that generates and
emits X-rays, including a standard stationary anode X-ray source, a
microfocus x-ray source, a rotating anode x-ray source, and/or a
fluoroscopic X-ray source. And the X-ray detector 140 can contain
any detector that detects X-rays, including an image intensifier, a
CMOS camera and/or a digital flat panel detector. In some
configurations, the detector can have a substantially square shape
with a length ranging from about 13 cm to about 15 cm. In other
configurations, the detector can have a substantially rectangular
shape with the shorter dimension ranging from 12 cm to 16 cm, and
the longer dimension ranging from 18 cm to 24 cm. The X-ray source
135 can be contained in a housing that can be configured in two
parts with a first part enclosing the x-ray source 135 and a
second, separate part enclosing the x-ray detector 140. In other
configurations, however, the housing can be configured so that it
is a single part that encloses both the X-ray source 135 and the
X-ray detector 140.
[0020] In some configurations, the housing can also enclose a
removable power source (such as a battery) and optionally a power
supply. Thus, the power source and the power supply can be located
internal to the housing and also to the x-ray device 100. The
supporting electronics for the power source and the power supply,
as well as the supporting electronics for an image display and for
wireless data upload, can also be located internal to the housing.
Thus, in these configurations, the x-ray device 100 does not
contain an external power cord or data cable. Incorporating the
power source (i.e., the battery), the power supply, and the
supporting electronics all within the housing allows the size and
the weight of the device to be reduced. With such a configuration,
the power source can easily be replaced and delivers 60 or more
x-ray images using a single charge. Of course, if needed, the x-ray
device can be configured so that it is alternately, or
additionally, charged using external power from a power cord that
is plugged into a wall outlet. In other configurations, multiple
power supplies can be provided for the source, detector, and
control electronics, any (or all) of which can be located either
internal or external to the housing.
[0021] The X-ray device 100 also contains a frame 150 that has an
open configuration. As shown in FIG. 1, an open configuration gives
a number of easy gripping options for a user to carry and hold the
frame 150 during transport, and optionally during operation of the
x-ray device 100. In some embodiments, the frame 150 can be
configured as a modular unit so different cross members (or length
member or handles) can be used to replace the existing cross
members (or length member or handles). Thus, the frame 150 provides
the ability for a user (or operator) to grip and hold the X-ray
device 100 during operation, a feature that is useful since other
conventional C-arms can't be held in the hands while being operated
because they do not have a suitable frame and because they are too
heavy.
[0022] In other embodiments, the portable x-ray device has the
configuration as illustrated in FIG. 2. In the embodiments of FIG.
2, the frame 150 has a first portion 155 that is part of the
housing that also contains the x-ray source 135 and the associated
electronics. The frame 150 also has a second portion 160 that is
part of the housing that also contains the x-ray detector 140 and
the associated electronics. The first portion 155 of the housing
and the second portion 160 of the housing are connected using hinge
165. The bottom of the portable x-ray device can contain an opening
175.
[0023] The portable x-ray device 100 has several features not
exhibited by other C-arm devices. First, it has the capability of
wireless data transfer, thereby eliminating the need for any wired
connections or cables to the C-arm. Second, it is internally
powered by a battery or internal power source and, therefore, more
portable than other C-arm devices which require a power cable.
Third, it is lighter that other C-arm devices. As a comparison, the
portable x-ray C-arm devices 100 described herein can have a weight
ranging from about 10 to about 25 pounds while other C-arm devices
have a weight ranging from about 35 to about 375 pounds. In other
embodiments, the portable x-ray C-arm devices 100 described herein
can have a weight ranging from about 12 to about 18 pounds.
[0024] In some embodiments, the portable x-ray device 100 can be
connected to a stationary external (or support) structure so that
it can rotate, or be positioned, around an object being analyzed,
as shown in FIGS. 3A and 3B and as described in U.S. patent
application Ser. No. 15/568,708, filed Nov. 23, 2017, the entire
disclosure of which is incorporated herein by reference. In other
embodiments, the portable x-ray device 100 can be connected to a
mobile external (or support) structure for a similar purpose, as
shown in FIGS. 4 and 5 as described in U.S. patent application Ser.
No. 16/198,956, filed Nov. 23, 2018, the entire disclosure of which
is incorporated herein by reference. Attaching the portable x-ray
device to a support structure allows the operator to position the
portable x-ray device 100 as needed for a series of imaging
procedures, while freeing medical personnel to attend to other
duties. As well, it leaves the hands of the operator free for other
actions. For example, during a surgical procedure, attaching the
portable x-ray device 100 to a support structure allows the medical
person to take many actions, but then easily image the patient when
needed using the pre-selected positioning of the portable x-ray
device 100. When the surgical procedure is complete, the portable
x-ray device 100 can be removed from the support structure and
taken to another location for use or storage.
[0025] With some conventional support structures, though, removing
the portable x-ray device 100 from the support structure is either
not possible, or is not an easy or quick procedure. For example,
with the conventional support structure shown in FIG. 13, the x-ray
device can only be removed by loosening the clamp connecting it to
rest of the system, but this action does not really release the
x-ray device from the x-ray system since it is still connected to
the support structure by power and data cables. Thus, it cannot be
easily taken to a new location and it is not truly a portable x-ray
device. And with the conventional support structure shown in FIG.
14, the c-arm x-ray device can't be even removed from the support
structure.
[0026] To overcome these difficulties, the portable x-ray device
100 in some embodiments can be connected to an external (or
support) structure using a connecting mechanism that is secure, yet
also capable of being operated by one hand while the other hand
holds the portable x-ray device 100 for safety during the
connection process. Using such a connecting mechanism allows an
operator to quickly and easily attach (and remove) the portable
x-ray device 100 from the support structure and move it freely once
disconnected, making the portable x-ray device 100 truly
mobile.
[0027] In these embodiments, a connecting member 900 is used to
flexibly connect the portable x-ray device 100 to any desired
supporting structure. As shown in FIG. 6, an extension arm 800 of
the support structure can be connected to an end of the connecting
member 900. The other end of the connecting member is connected to
a cradle 910 into which the portable x-ray device 100 rests. The
cradle 910 is configured so that it has a surface that conforms to
or meshes with the outer surface of the housing of the portable
x-ray device 100 or any other desired part of the portable x-ray
device 100. The portable x-ray device 100 can be attached and
secured to the cradle 910 so that its position relative to the
extension arm 800, and its orientation in three dimensions, is
controlled by connecting member 900 during operation of the x-ray
device 100. Once operation of the portable x-ray device 100 is
concluded, the portable x-ray device 100 can be detached from the
cradle 910.
[0028] The cradle 910 also contains mounting plate(s) or support(s)
920 that are used to support the bottom of the portable x-ray
device 100, as shown in the perspective view of FIG. 7 and the
bottom view of FIG. 8. The mounting plates 920 are designed to
support and contain the bottom of the portable x-ray device 100
when the portable x-ray device 100 rests on the cradle 910. So with
the configuration of the portable x-ray device 100 shown in FIG. 2,
the mounting plates 920 are configured to contain length members
925 with ridges 927 that are configured to extend along the length
of the bottom sides of the portable x-ray device 100. The mounting
plates 920 also contain width members 935 that extend between the
length members 925. The width members are configured to extend
along the width of the bottom of the portable x-ray device and
provide rigidity to the mounting plates 920 and the entire cradle
910. While only two width members 935 are shown in FIGS. 7-8, the
mounting plates 920 could have more or less than those shown in
these Figures. Optionally, the mounting plates 920 could contain
width members with ridges that could be located to extend along the
width of the bottom sides of the portable x-ray device 100, thereby
fully enclosing the bottom of the portable x-ray device.
[0029] The connecting member 900 also contains several features
that can be used to secure or clamp the portable x-ray device 100
into place in the cradle 910 and the mounting plates 920. One of
these features comprises insert 930 that is located near the middle
of the mounting plates. The insert 930 extends upwards from the
mounting plates 920 and is configured with a size and shape that
mates with an opening 175 in the portable x-ray device 100. The
mating of an opening 175 in the portable x-ray device 100 as
depicted that accepts the insert 930 as depicted provides immediate
registration and location of the portable x-ray device 100
accurately on the cradle 910. This is helpful for a quick
attachment and/or quick release of the portable x-ray device 100.
Without such a registration feature, the medical personnel
operating the portable x-ray device 100 would spend precious time
adjusting and positioning the portable x-ray device 100 on the
cradle 910 instead of on the needed part of the medical procedure.
And with such a registration feature, the registration is
automatic.
[0030] In other embodiments, the registration insert 930 and
matching opening 175 could be rectangular in shape, or circular, or
oval, or any other shape that allows the combination of the opening
175 and the insert 930 together. As well, the height of the
registration insert 130 (and the corresponding depth of the opening
175) can be modified from what is shown in the Figures. And while a
single registration feature is shown in the Figures, multiple
registration features with the same or different sizes and shapes
(along with matching openings in the portable x-ray device 100) can
be used. In other embodiments, the registration insert could be
located on the portable x-ray device 100 and a matching insert
could be located on the mounting plate(s).
[0031] Another securing feature in cradle 910 is the clamps 940.
The clamps 940 are located on the ridges (or side stiffeners) 927
of the length members 925 of the mounting plates 920 so that they
are situated on opposing sides of the bottom of the portable x-ray
device 100. The clamps 940 can remain open when not used and closed
on the portable x-ray device 100 when needed. Alternatively, the
clamps 940 could be closed when not in use at the expense of an
additional motion or moment of time to open them before x-ray
device 100 could be mounted on the cradle 910. Examples of this
opening and closing action are shown in FIGS. 9-12 where the clamps
940 are in an open position in FIG. 9, partially closed positions
in FIGS. 10-11, and in a completely closed position in FIG. 12 to
secure the portable x-ray device 100 to the cradle 910 and mounting
plates 920.
[0032] The clamps 940 can be configured to meet multiple
requirements. One requirement is to have at least two independent
failure points in securing the portable x-ray device 100 to the
cradle 910. This functionality can be accomplished in part by
requiring that each of the clamps 940 have a separate release
button, lever, or other mechanism that releases the clamp 940 from
the portable x-ray device 100. Thus, if one of the clamps 940 is
accidently opened or were to fail, the other clamp, combined with
the physical registration or constraining action of the insert 930
in the opening 175, would ensure that the portable x-ray device 100
cannot slip or fall from the cradle 910, even if it is no longer
snuggly or firmly fixed in the cradle 910.
[0033] This functionality demonstrates another benefit obtained by
using the insert 930. Not only does insert 930 register the
portable x-ray device 100 as described herein, but it also acts to
help secure the x-ray device 100 in the cradle 910 against
accidental release. In order to accomplish this function, the
insert 930 should mesh snuggly and reasonably tight within the
opening 175. But if the fit is too tight, then the portable X-ray
device 100 will be difficult to mount or remove from the cradle
910. Yet if the fit is too loose, the insert 930 may not act
appropriately as part of the secure mounting system described
herein. So a balanced fit has to be used.
[0034] In other embodiments, additional clamps 940 could be used on
the mounting plates 920 so that that the cradle 910 contains 3, 4
or even more clamps. Additional clamps could be positioned on the
bottom of cradle 910 to clamp the portable x-ray device 100 by
securing the length members 925 of the C-arm against the mounting
plates 920, or by mounting them in other ways. However, the use of
more than 2 clamps may not be needed in some embodiments since
additional clamps will complicate the mounting or removal of the
portable x-ray device 100 to the cradle 910 without providing
additional security or physical stability beyond that provide by
just using two clamps.
[0035] In other configurations, the clamps 940 and the portable
x-ray device 100 can be provided with matching features to help the
clamping function. For example, the clamps 940 depicted in FIG. 7
contain extensions 950 that are flexible and compress when the
clamps 940 are secured on the housing of the portable x-ray device
100 in order to provide some positive pressure on the x-ray device
100 to keep it firmly seated. But the extensions 950 could also be
configured to be inflexible and mated to matching indentations in
the portable x-ray device (not shown).
[0036] The clamps 940 can be actuated or applied to the portable
x-ray device 100 in any number of ways. It is possible for the
clamps 940 to be spring loaded such that they snap shut on the
x-ray device 100 when actuated by a button, a lever, or some other
feature. Alternatively, the clamps 940 could be actuated by a
clamping lever (not shown) that would work within the clamping
mechanism to close the clamps and apply pressure to secure the
x-ray device 100. In other embodiments, the clamps 940 could be
designed to contain an internal ratchet mechanism (or similar
functionality) that is light enough in action that the clamps can
be pressed or squeezed closed using one hand and the pressure of
the fingers and palms and retain the clamps 940 in the closed
position automatically, retaining the pressure against the portable
x-ray device 100 that was initially imparted by hand. This ratchet
mechanism can also be configured to only partially open when
initially released by the operator using the button, lever, or
other actuator, so that the C-arm of the portable x-ray device 100
can't fall out of the cradle 910 until the clamp 940 has been fully
released with a second activation of the release mechanism.
[0037] The portable x-ray device 100 can quickly and easily be
attached and removed from the cradle 910 and mounting plates 920
using a single hand by an average sized operator in the following
manner. When the clamps 940 are in the open position shown in FIG.
7, the portable x-ray device can be carried by hand and placed onto
the cradle and mounting plates so that the insert 930 fits within
the opening 175, as shown in FIG. 9. The clamps 940 can then be
closed by an operator, as shown in FIGS. 10-12. The portable x-ray
device 100 can then be operated to take an x-ray image of the
patient without the medical personnel constantly holding the
portable x-ray device 100. When needed, the clamps 940 can be
opened by pressing the button or otherwise activating the release
mechanism, and then the portable x-ray device 100 can be easily
lifted off the cradle/mounting plates using only a single hand by
the average person.
[0038] When the portable x-ray device 100 is attached to the cradle
and mounting plates, it can be used in imaging procedures of a
patient. Some of those imaging procedures can be performed during a
surgical procedure where a sterile field needs to be maintained.
One manner of maintaining a sterile field is by using a sterile bag
around the portable x-ray device 100. To keep the sterile field,
the clamps 940 and the insert 930 must be configured so that such a
sterile bag is not punctured when the clamps are closed.
[0039] In some configurations, the connecting member 900 containing
the cradle 910 is connected to a supporting device, such as a
support stand. The support stand that is attached to and supports
the cradle 910 through connection member 900 will intentionally or
may accidentally be brought close to the patient. To maintain a
sterile field near the patient, a sterile bag can be placed over
the support stand and the cradle 910 before the portable x-ray
device 100, in a separate sterile bag, is mounted or placed in the
cradle 910. In other words, two sterile bags can be used: a first
sterile bag covering the cradle 910, the connecting member 900, and
the rest of the support stand as appropriate, and a second sterile
bag around the portable x-ray device 100 itself. Such a
configuration will allow the portable x-ray device 100 to be
maintained sterile, while simultaneously allowing for the rapid and
easy removal of the portable x-ray device 100 during the medical
procedure.
[0040] This requirement of using two sterile bags in these
embodiments can introduce additional constraints on the insert 930,
the clamps 940, and even on the mounting plates 920, as well as
other components of the portable x-ray device 100, especially the
opening 175. The first constraint is that all of these features,
whether part of the cradle 910, the x-ray device 100, or the clamps
940, must be designed with rounded surfaces, chamfers, or other
means to smooth corners and edges so that the sterile bags cannot
be caught and torn, or punctured. In some configurations, the
corners, edges, chamfers, and other rounding of features have a
minimum radius no smaller than about 0.5 mm, with about 1.0 mm or
about 2.0 mm as a more practical minimum since the sharper the
corner (i.e., the smaller the radius), the more easily a polymer
film sterile bag can be torn or inadvertently penetrated. The
minimum corner radius also depends on the shape of the feature. If,
for example, the feature is a flat plate or surface that is only 2
mm or 3 mm thick, the corner radius will essentially become a flat
circle with a radius of one half the thickness of the plate. This
configuration would be the case for many handles, levers, and other
such features.
[0041] It is also desirable that all surfaces must have some
significant area so that there is no feature (including features
such as handles, clamping levers, and similar devices) that is
capable of, or likely to, puncture the sterile bag if the bag is
stretched across the physical feature. So handles, clamping levers,
and similar devices can be designed or angled to lie close to the
adjacent surface in order to avoid any features that poke out from
the over-all device at large angles of about 60 degrees, about 70
degrees, about 80 degrees, or about 90 degrees. Handles, clamping
levers, and similar devices should also have a rounded end with a
radius of at least about 2 mm, about 3 mm, about 4 mm, or even
about 5 mm in order to avoid punctures of the sterile bag polymer
sheet. Additionally, any hinges, such as in the clamps 940 must be
designed to ensure that a thin plastic sheet or membrane from a
sterile bag cannot be caught, torn, or punctured by the operation
of the clamps 940.
[0042] An additional constraint is that the clamp 940 must be able
to accommodate the variations in the clamping conditions caused by
the absence of any sterile bags, or the presence of 1, 2, 3 4, 5,
or even more layers of plastic between the x-ray device 100 and the
cradle 910, clamps 940, and/or resilient pads 950. These
intervening layers can be caused by sterile drapes on the support
stand and/or the portable x-ray device 100 since one or more folds
in the sterile bag material might be captured between the x-ray
device 100 and the cradle 910, clamps 940, and/or resilient pads
950. These folds can be introduced because sterile drapes are
designed to be somewhat loose and baggy to allow for the quick
application of the sterile bag over the component to be rendered
(or maintained) sterile. This looseness is often dealt with by
gathering some folds together at various locations of the component
that is covered by the sterile bag.
[0043] Therefore, the clamps 940 and the resilient pads 950 need to
be able to accommodate a variety of clamping conditions. For
example, if the sterile bag material is 5 thousandths of an inch
(i.e., 5 mils or 0.127 mm) thick, the clamping mechanism needs to
be able to successfully and adequately clamp the portable x-ray
device 100 with the variation in the total effective material
thickness ranging from 5 mils, to 10 mils, 15 mils, 20 mils, 25
mils, 30 mils, or even more. Converting to millimeters, the
equivalent thickness could vary by about 0.1 mm, to 0.2 mm, 0.3 mm,
0.4 mm, 0.5 mm, up to 0.6 mm, 0.7 mm, or even more. The resilience
that the clamping mechanism needs to deal with such a broad
variation in thickness could be designed into the pad 950 by using
rubber, foam, foam rubber, or similar material. It also could be
designed into a combination of the pad 950, the clamp 940 and its
mechanism, and/or even into the design of the cradle 910 by
incorporating a resilient foam, or rubber, or other such resilient
material into the cradle 910 by placing it on the length members
925 and width members 935.
[0044] In addition to any previously indicated modification,
numerous other variations and alternative arrangements may be
devised by those skilled in the art without departing from the
spirit and scope of this description, and appended claims are
intended to cover such modifications and arrangements. Thus, while
the information has been described above with particularity and
detail in connection with what is presently deemed to be the most
practical and preferred aspects, it will be apparent to those of
ordinary skill in the art that numerous modifications, including,
but not limited to, form, function, manner of operation and use may
be made without departing from the principles and concepts set
forth herein. Also, as used herein, the examples and embodiments,
in all respects, are meant to be illustrative only and should not
be construed to be limiting in any manner.
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