U.S. patent application number 12/447833 was filed with the patent office on 2010-06-03 for fluoroscopy operator protection device.
Invention is credited to Amir Belson.
Application Number | 20100133450 12/447833 |
Document ID | / |
Family ID | 40002785 |
Filed Date | 2010-06-03 |
United States Patent
Application |
20100133450 |
Kind Code |
A1 |
Belson; Amir |
June 3, 2010 |
FLUOROSCOPY OPERATOR PROTECTION DEVICE
Abstract
A radiation protection device attaches to the C-arm of a
fluoroscope and shields and collimates the X-ray beam between the
X-ray source and the patient and between the patient and the image
intensifier. One embodiment has a radiation shield of X-ray opaque
material that surrounds the C-arm of the fluoroscopy system, the
X-ray source and the image intensifier. A padded slot fits around
the patient's body. Another embodiment has conical or cylindrical
radiation shields that extend between the X-ray source and the
patient and between the patient and the image intensifier. The
radiation shields have length adjustments and padded ends to fit
the device to the patient. The radiation protection device may be
motorized to advance and withdraw the radiation shields. A
blanket-like radiation shield covers the patient in the area
surrounding where the X-ray beam enters the body.
Inventors: |
Belson; Amir; (Los Altos,
CA) |
Correspondence
Address: |
SHAY GLENN LLP
2755 CAMPUS DRIVE, SUITE 210
SAN MATEO
CA
94403
US
|
Family ID: |
40002785 |
Appl. No.: |
12/447833 |
Filed: |
November 13, 2007 |
PCT Filed: |
November 13, 2007 |
PCT NO: |
PCT/US07/23892 |
371 Date: |
February 4, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60858058 |
Nov 11, 2006 |
|
|
|
60923481 |
Apr 13, 2007 |
|
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Current U.S.
Class: |
250/519.1 ;
250/515.1; 378/203 |
Current CPC
Class: |
A61B 6/589 20130101;
A61B 6/4441 20130101; A61B 6/107 20130101; A61B 6/487 20130101;
A61B 6/4423 20130101 |
Class at
Publication: |
250/519.1 ;
250/515.1; 378/203 |
International
Class: |
G21F 3/00 20060101
G21F003/00; H01J 35/16 20060101 H01J035/16 |
Claims
1. A radiation protection device for a fluoroscope of the type
having an X-ray source and an image intensifier mounted on a C-arm,
the radiation protection device comprising: a first radiation
shield surrounding the X-ray source and extendable to contact a
body of a patient positioned within the C-arm; a second radiation
shield surrounding the image intensifier and extendable to contact
the body of the patient positioned within the C-arm; a first motor
for selectively extending and retracting the first radiation
shield; and a second motor for selectively extending and retracting
the second radiation shield.
2. The radiation protection device of claim 1, wherein the first
radiation shield is conical.
3. The radiation protection device of claim 2, wherein the second
radiation shield is conical.
4. The radiation protection device of claim 1, wherein the first
radiation shield is cylindrical.
5. The radiation protection device of claim 4, wherein the first
radiation shield is cylindrical.
6. The radiation protection device of claim 1, wherein the first
radiation shield has a soft, conformable edge for contacting the
surface of the patient.
7. The radiation protection device of claim 6, wherein the second
radiation shield has a soft, conformable edge for contacting the
surface of the patient.
8. The radiation protection device of claim 1, further comprising a
third radiation shield configured to cover a portion of the patient
adjacent to, but not covering, the portion of the patient being
imaged with the fluoroscope.
9. The radiation protection device of claim 1, further comprising a
first sensor configured for sensing proximity or contact of the
first radiation shield with the patient and means for stopping the
first motor from extending the first radiation shield when the
first sensor detects proximity or contact with the patient's
body.
10. The radiation protection device of claim 9, further comprising
a second sensor configured for sensing proximity or contact of the
second radiation shield with the patient and means for stopping the
second motor from extending the second radiation shield when the
second sensor detects proximity or contact with the patient's
body.
11. A radiation protection device for a fluoroscope of the type
having an X-ray source and an image intensifier mounted on a C-arm,
the radiation protection device comprising: a radiation shield
surrounding the X-ray source and an image intensifier mounted on a
C-arm; the radiation shield having a first approximately planar
side wall and a second approximately planar side wall joined
together by a peripheral wall, slot-shaped opening through the
first and second side walls and the peripheral wall configured to
fit the radiation shield around a portion of a patient's body to be
imaged.
12. The radiation protection device of claim 11, wherein the
opening in the radiation shield has a soft, conformable edge for
contacting the surface of the patient.
13. The radiation protection device of claim 11, wherein the
radiation shield has a C-arm attached portion and a
patient-stationary portion, and an overlapping, sliding joint
allowing relative movement between the C-arm attached portion and
the patient-stationary portion.
Description
CROSS REFERENCE TO OTHER APPLICATIONS
[0001] The present application claims the benefit of U.S.
Provisional Application Ser. No. 60/858,058, filed on Nov. 11, 2006
and U.S. Provisional Application Ser. No. 60/923,481, filed on Apr.
13, 2007, the disclosures of which are incorporated by
reference.
FIELD OF THE INVENTION
[0002] The present invention relates to radiation protection
devices to protect fluoroscopy operators and other medical
personnel from radiation exposure during fluoroscopic imaging
procedures.
BACKGROUND OF THE INVENTION
[0003] Fluoroscopy, a real-time X-ray imaging technique, has long
been important as a medical diagnostic tool, particularly in
disciplines where still X-rays do not provide sufficient diagnostic
information of the movement and function of living, moving organs.
Fluoroscopy is widely used in cardiology, electrophysiology,
gastroenterology and orthopedics. With the recent growth in
catheter-based interventional cardiology and radiology procedures,
there has been a tremendous increase in the use of fluoroscopy.
Many life saving interventional procedures would not be possible
without the use of fluoroscopy. However, fluoroscopic imaging
exposes the patient and attendant medical personnel to potentially
harmful X-ray radiation. For the patient, some exposure to X-rays
is necessary to produce the fluoroscopic images and the exposure is
usually brief and infrequent. The benefit to the patient is
sufficient to outweigh the potentially harmful effects of the X-ray
radiation. However, medical personnel involved in fluoroscopic
imaging are exposed to significant doses of X-ray radiation on a
daily basis. This is particularly true for interventional
cardiologists and radiologists who must work in close proximity to
the patient who is undergoing fluoroscopic imaging and for
orthopedists manipulating a joint while observing it under
fluoroscopy.
[0004] X-ray exposure to medical personnel comes from two sources,
direct exposure to the X-ray beam and scattered X-rays. Direct
exposure occurs when the operator's hands or other body parts are
placed in the X-ray beam while the fluoroscope is operating. X-ray
scattering occurs when X-rays strike electrons in the patient's
tissue and are deflected back and to the sides at angles that are
not parallel to the incident beam. While scattered X-rays are much
lower intensity than the direct X-ray beam, it is much more likely
for the operator to be exposed to scattered X-rays and the damaging
effects are cumulative from months and years of exposure.
[0005] Most states require that all medical personnel who work in
the room during fluoroscopy wear protective equipment, typically a
radiation resistant apron or the like providing protection
equivalent to 0.25-0.5 mm of lead, depending on state regulations
and the intensity of the X-ray source utilized. Depending on the
thickness used, lead aprons absorb 90-99 percent of X-ray radiation
striking the apron. However, they only protect the areas of the
body that are covered and it is recommended that personnel who work
frequently and in close proximity to the fluoroscope also wear
additional protection, such as thyroid protectors, lead filled
glasses and face shields. Exposed areas of the body are still
susceptible to X-ray exposure.
[0006] Though necessary for radiation protection, the lead aprons
are heavy and uncomfortable, resulting in fatigue and injuries.
Back, knee and ankle injuries are common among personnel who
frequently work in the fluoroscopy laboratory with a lead apron on.
X-ray exposure, fatigue and injuries would all be expected to
increase for operators involved in long, complex interventional
procedures requiring fluoroscopic imaging.
[0007] Due to the incomplete radiation protection provided by lead
aprons and leaded glasses and the increased likelihood of fatigue
and injuries, it would be desirable to provide a radiation
protection device that provides more complete protection and that
reduces or eliminates the necessity for using heavy radiation
protection garments. Such a device would ideally protect the
fluoroscope operator and all nearby personnel from direct exposure
to the X-ray beam and from scattered X-rays. The device should not
interfere with the performance of the fluoroscopy or any diagnostic
or therapeutic procedures performed during fluoroscopy. Preferably,
the device would be free of other inconveniences to the operator or
the patient. A truly effective radiation protection device could
reduce the overall cost of radiation protection by eliminating the
need for lead aprons and other protective gear and could even
simplify the construction of the fluoroscopy suite in the hospital
by decreasing the amount of radiation shielding necessary.
SUMMARY OF THE INVENTION
[0008] In keeping with the foregoing discussion, the present
invention provides a radiation protection device with one or more
radiation shields that attach to the C-arm of the fluoroscopy
system and shields and collimates the X-ray beam between the X-ray
source and the patient and between the patient and the image
intensifier. This will protect the operator from inadvertently
being exposed to the direct X-ray beam and will eliminate a
significant percentage of the scattered X-rays. To eliminate the
remainder of the scattered X-rays that emanate from the patient,
the radiation protection device may also include a blanket-like
radiation shield that covers the patient in the area surrounding
where the X-ray beam enters the body. Optionally, the blanket-like
radiation shield may be connected to the radiation shield(s) on the
C-arm.
[0009] In one embodiment, the radiation protection device has a
radiation shield of X-ray opaque material that surrounds the C-arm
of the fluoroscopy system, the X-ray source and the image
intensifier. A slot or opening is provided to fit the radiation
shield around the patient's body. A soft, flexible material
surrounds the opening to comfortably fit the radiation shield to
the contours of the patient's body and to accommodate some motion
of the C-arm relative to the patient.
[0010] In another embodiment, the radiation protection device has a
first conical or cylindrical radiation shield that extends from the
X-ray source to the patient or to the procedure table and a second
conical or cylindrical radiation shield that extends from the
patient to the image intensifier. The first radiation shield and
the second radiation shield have length or height adjustments to
fit the device to the patient and to accommodate motion of the
C-arm relative to the patient. A soft, flexible material surrounds
the openings of the first radiation shield and the second radiation
shield to comfortably fit them to the contours of the patient's
body. Optionally, the radiation protection device has electric
motors or the like for withdrawing and advancing the first
radiation shield and the second radiation shield from contact with
the patient so that the C-arm can be freely moved and repositioned
relative to the patient. Optionally, the second radiation shield
may have one or more hand ports to allow the operator to work on
the area of the patient under the second radiation shield without
withdrawing it from contact with the patient.
[0011] Each embodiment of the radiation protection device may also
include a blanket-like radiation shield that covers the patient in
the area surrounding where the X-ray beam enters the body.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 illustrates a prior art C-arm fluoroscopy system.
[0013] FIG. 2 illustrates one embodiment of the radiation
protection device mounted on the C-arm of the fluoroscopy
system.
[0014] FIG. 3 illustrates a variation of the radiation protection
device of FIG. 2.
[0015] FIG. 4 illustrates an embodiment of the radiation protection
device with a first radiation shield and a second radiation shield
mounted on the C-arm of the fluoroscopy system.
[0016] FIG. 5 illustrates a radiation shield with a hand port.
[0017] FIG. 6 illustrates a radiation shield with two hand
ports.
[0018] FIG. 7 illustrates an embodiment of the radiation protection
device with motors for extending and retracting the first radiation
shield and the second radiation shield.
[0019] FIG. 8 illustrates a blanket-like radiation shield that
covers the patient except the area that is being imaged.
[0020] FIG. 9 illustrates a radiation shield elevated slightly
above and surrounding the patient.
[0021] FIG. 10 illustrates a radiation shield suspended from the
X-ray source of the fluoroscopy system.
DESCRIPTION OF THE INVENTION
[0022] FIG. 1 illustrates a prior art C-arm fluoroscopy system 100.
The fluoroscope 100 includes an X-ray source 102 and an image
intensifier 104 mounted on opposite ends of a C-arm 106. In use,
the X-ray source 102 and the image intensifier 104 are placed on
opposite sides of the portion of the patient's body to be imaged.
The X-ray source 102 directs an X-ray beam through the patient's
body toward the image intensifier 104, which captures the X-ray
image and displays it on a monitor 108 in real time. Often, the
X-ray source 102 is positioned below the patient and the image
intensifier 104 is positioned above as shown, however for some
applications these positions may be reversed or the C-arm 106 may
be positioned horizontally. The system may also include electronic
memory for storing and replaying fluoro images and a cine camera
for capturing fluoro images on film. For catheterization laboratory
use, the C-arm 106 will be mounted beside or at the head end of a
procedure table. The C-arm 106 can be moved and rotated to position
the X-ray source 102 and the image intensifier 104 for the best
images of the target anatomy. Often, the X-ray source 102 is
positioned below the patient and the image intensifier 104 is
positioned above as shown, however for some applications these
positions may be reversed or the C-arm 106 may be positioned
horizontally or at an oblique angle.
[0023] FIG. 2 illustrates one embodiment of the radiation
protection device 110 mounted on the C-arm 106 of the fluoroscopy
system 100. The radiation protection device 110 includes a
radiation shield 112 of X-ray opaque material that surrounds the
C-arm 106 of the fluoroscopy system 100, the X-ray source 102 and
the image intensifier 104. The radiation shield 112 has a first
approximately planar side wall 114 and a second approximately
planar side wall 116 joined together by a peripheral wall 118. A
slot or opening 120 through the first and second side walls 114,
116 and the peripheral wall 118 is provided to fit the radiation
shield 112 around the patient's body and, optionally, the procedure
table, as appropriate for the intended use. The back side of the
peripheral wall 118 will have an opening or extended slot 126 for
the support arm 128 that holds the C-arm 106. A pad 122 of soft,
flexible material surrounds the opening 120 to comfortably fit the
radiation shield to the contours of the patient's body and to
accommodate some motion of the C-arm 106 relative to the patient.
Optionally, the opening 120 can be covered with a material that is
transparent to X-rays. The pad 122 around the opening 120 may be an
inflatable or foam-filled rim of lead-filled rubber or other soft,
conformable structure. The radiation protection device 110 may be
joined directly to the C-arm 106 with fasteners and/or adhesives or
it may be an independent structure that can be placed on and
removed from the C-arm 106, for example with zippers, magnets,
snaps, straps, hook-and-loop fasteners, etc.
[0024] The radiation shield(s) in this and other embodiments may be
made with lead shielding, a composite material or other X-ray
opaque material. Preferably, the radiation shielding material will
provide protection equivalent to 0.5 mm of lead or greater so that
additional radiation protection will not be needed. For example,
U.S. Pat. No. 4,795,654 describes a composite X-ray opaque material
with a triple layer structure. The first layer can be build from
uranium, lead and gold among others. The second layer may be made
of tin, and indium among others and the third layer made of zinc,
copper, nickel and chromium among others. Optionally, the shielding
material may be flexible, such as lead filled rubber, and it may be
optically transparent, such as lead filled glass or a transparent
X-ray opaque plastic. A flexible polymeric X-ray opaque material
called DEMRON is available from Radiation Shielding
Technologies.
[0025] FIG. 3 illustrates a variation of the radiation protection
device 110 of FIG. 2 in which the radiation shield 112 has a C-arm
attached portion 126 and a patient-stationary portion 128. An
overlapping, sliding joint 130 between the C-arm attached portion
126 and the patient-stationary portion 128 allows a greater range
of motion of the C-arm 106 relative to the patient. Optionally, a
flap 124 of X-ray opaque material, preferably a flexible material,
may be provided to cover a portion of the opening 120 after it has
been passed around a body part. The flap 124 may be removably
attached, for example using magnets, snaps or hook-and-loop
fasteners.
[0026] In an alternate embodiment of the radiation protection
device 110 of FIG. 2, the radiation shield 112 may be independently
supported, so that it is held stationary relative to the patient,
allowing the C-arm 106 to move independently within the radiation
shield 112.
[0027] FIG. 4 illustrates an embodiment of the radiation protection
device 130 with a first radiation shield 132 and a second radiation
shield 134 mounted on the C-arm 106 of the fluoroscopy system 100.
The first radiation shield 132 is approximately conical or
cylindrical in shape and extends from the X-ray source 102 to the
patient, or to the procedure table 140 as appropriate for the body
part being imaged. The second radiation shield 134 is also
approximately conical or cylindrical in shape and extends from the
image intensifier 104 to the patient. The radiation shields 132,
134 are typically open on the ends closest to the patient, but,
optionally, the openings can be covered with a material that is
transparent to X-rays.
[0028] The first radiation shield 132 and the second radiation
shield 134 have length or height adjustments 136, 138 to fit the
device to the patient and to accommodate motion of the C-arm 106
relative to the patient. The length or height adjustments 136, 138
may be configured as overlapping telescopic joints, expandable
bellows joints or the like. A pad 142, 144 of soft, flexible
material surrounds the openings of the first radiation shield 132
and the second radiation shield 134 to comfortably fit them to the
contours of the patient's body. The pads 142, 144 around the
openings may be an inflatable or foam-filled rim of lead-filled
rubber or other soft, conformable structure. The length or height
adjustments 136, 138 and the conformable pads 142, 144 allow for a
significant degree of repositioning of the C-arm 106 relative to
the patient without having to readjust the radiation shields 132,
134. Optionally, the length or height adjustments 136, 138 may be
spring loaded with a light spring force to keep the radiation
shields 132, 134 in contact with the patient when the C-arm 106 is
adjusted without causing discomfort to the patient. For major
repositioning of the C-arm 106, the radiation shields 132, 134 will
preferably be withdrawn from contacting the patient in order to
allow free motion of the C-arm 106.
[0029] Optionally, the second radiation shield 134 may have one or
more hand ports to allow the operator to work on the area of the
patient under the second radiation shield 134 without withdrawing
it from contact with the patient. FIG. 5 illustrates a radiation
shield 134 with a single hand port 150 large enough for both of the
operator's hands and/or one or more instruments to fit through. The
hand port 150 is preferably fitted with a closure 156 of radiation
shielding material to prevent X-rays from escaping through the hand
port 150. In one preferred embodiment, the closure comprises a
plurality of overlapping flaps of flexible radiation shielding
material that will allow a hand or instrument to pass through and
will seal around the hand or instrument.
[0030] FIG. 6 illustrates a radiation shield with two hand ports
152, 154. Each of the hand ports 152, 154 is preferably fitted with
a closure 156 of radiation shielding material to prevent X-rays
from escaping through the hand ports 152, 154.
[0031] Preferably, when a hand port is included in the radiation
protection device 130, at least a portion of the radiation shield
134 will be made of transparent radiation shielding material so
that the operator can see the area under the radiation shield 134.
If the operator needs to have the hands inside of the radiation
shield 134 while the fluoroscope 100 is operating, it is highly
recommended that radiation shielding gloves be worn. In an
alternate embodiment, a pair of radiation shielding gloves could be
incorporated into the hand ports 152, 154.
[0032] Optionally, the radiation protection device 130 may be
motorized for extending and retracting the first radiation shield
132 and the second radiation shield 134 from contact with the
patient so that the C-arm can be freely moved and repositioned
relative to the patient. FIG. 7 illustrates an embodiment of the
radiation protection device 130 with motors 156, 158 for extending
and retracting the first radiation shield 132 and the second
radiation shield 134. The motors 156, 158 may be electric motors
with a rack and pinion mechanism, a scissors mechanism, or other
mechanism 133, 135 for translating the rotary motion of the motor
into linear motion of the radiation shields 132, 134. Optionally,
the operating mechanism may be spring loaded with a light spring
force to keep the radiation shields 132, 134 in contact with the
patient when the C-arm 106 is adjusted without causing discomfort
to the patient. For major repositioning of the C-arm 106, the
radiation shields 132, 134 will preferably be withdrawn from
contacting the patient in order to allow free motion of the C-arm
106. Alternatively, pneumatic or hydraulic actuators may be used in
place of the electric motors.
[0033] Preferably, the radiation protection device 130 will also
include sensors 160, 162, such as proximity sensors, optical
sensors, contact sensors, etc., that will stop the telescopic
extension of the radiation shields 132, 134 when they are in the
right contact with the patient. One option would be to have the
conforming pads 142, 144 around the openings of the radiation
shields 132, 134 mechanized to operate in a coordinated sequence
with the extension and retraction of the radiation shields 132,
134. In one example, the conforming pads 142, 144 could be
inflatable. The radiation shields 132, 134 would extend
telescopically with the pads 142, 144 deflated until the sensors
160, 162 detect close proximity or initial contact with the
patient's body, then the radiation shields 132, 134 would stop
extending and the pads 142, 144 would inflate to close any gap left
between the radiation shields 132, 134 and the patient.
[0034] Alternately or in addition, force sensors connected with the
motors 156, 158 could be used to sense when the radiation shields
132, 134 are in contact with the patient.
[0035] An interlock switch could be included to prevent the
fluoroscope 100 from operating unless the sensors 160, 162 confirm
that the radiation shields 132, 134 are in contact with the
patient's body. In addition, one or more X-ray detectors could be
positioned on or near the radiation protection device 130 outside
of the radiation shields 132, 134 to detect X-ray leakage and
connected to an interlock switch that shuts down the X-ray source
if stray X-ray radiation is detected.
[0036] Each embodiment of the radiation protection device may also
include a blanket-like radiation shield that covers the patient in
the area surrounding where the X-ray beam enters the body.
Optionally, the blanket-like radiation shield may be connected to
the radiation shield(s) on the C-arm.
[0037] FIG. 8 illustrates a blanket-like radiation shield 170 that
covers the patient except the area that is being imaged. The
blanket-like radiation shield 170 is preferably made of a flexible
X-ray opaque material that covers most of the patient, except a
fenestrated area 172 over the portion of the patient that is to be
imaged. For catheter procedures, a second fenestration may be
positioned over the vascular access site, for example the femoral
or brachial artery or the jugular vein.
[0038] Preferably, the radiation shielding material will provide
protection equivalent to 0.5 mm of lead or greater. Because
scattered X-rays are only partially attenuated in the body, this
level of protection will preferably extend at least to areas of the
body within a meter of where the X-ray beam enters the patient's
body. Optionally, the blanket-like radiation shield 170 may have a
removable cover for patient comfort and for ease in sanitizing the
patient-contact portions of the device. The removable cover may be
washable and reusable or it may be a single-use sterile disposable
cover.
[0039] FIG. 9 illustrates a radiation shield 180 elevated slightly
above and surrounding the patient, except a fenestrated area 182
over the portion of the patient that is to be imaged. If a rigid
radiation shielding material is used, the radiation shield 180 may
be self-supporting. Otherwise, a flexible radiation shielding
material supported on a frame over the patient.
[0040] In addition, another radiation shield may extend under the
patient, with another fenestration under the portion of the patient
to be imaged. Optionally, this radiation shield may be an extension
of the blanket-like radiation shield 170, 180 that is over the
patient. Alternatively, the procedure table may be made partially
of radiation shielding material with an X-ray transparent portion
beneath the portion of the patient to be imaged, however this
option potential limits the usability of the procedure table for
different types of procedures.
[0041] FIG. 10 illustrates a radiation shield 190 suspended from
the X-ray source 102 of the fluoroscopy system 100. This is a
curtain-like radiation shield 190 that hangs down between the X-ray
source 102 and the floor to stop scattered X-ray radiation. This
radiation shield 190 may be used separately or in combination with
one of the embodiments of'the radiation protection device described
above.
[0042] Alternatively or in addition, the radiation protection
device may be used for protection from other types of radiation,
for example gamma rays, that are used in medical or industrial
imaging or other diagnostic or therapeutic medical procedures.
[0043] While the present invention has been described herein with
respect to the exemplary embodiments and the best mode for
practicing the invention, it will be apparent to one of ordinary
skill in the art that many modifications, improvements and
subcombinations of the various embodiments, adaptations and
variations can be made to the invention without departing from the
spirit and scope thereof.
* * * * *