U.S. patent application number 15/639777 was filed with the patent office on 2017-10-26 for shielding device and method.
This patent application is currently assigned to Radux Devices, LLC. The applicant listed for this patent is Radux Devices, LLC. Invention is credited to Gregory Gordon, Douglas Scott Wahnschaffe.
Application Number | 20170309357 15/639777 |
Document ID | / |
Family ID | 55163473 |
Filed Date | 2017-10-26 |
United States Patent
Application |
20170309357 |
Kind Code |
A1 |
Gordon; Gregory ; et
al. |
October 26, 2017 |
SHIELDING DEVICE AND METHOD
Abstract
Some embodiments of a shielding device can include a base and a
shield coupled to the base. The shielding device can be used to
provide protection for a healthcare worker (e.g., physician, nurse,
technician) during a medical procedure.
Inventors: |
Gordon; Gregory; (Omaha,
NE) ; Wahnschaffe; Douglas Scott; (Monticello,
MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Radux Devices, LLC |
Omaha |
NE |
US |
|
|
Assignee: |
Radux Devices, LLC
Omaha
NE
|
Family ID: |
55163473 |
Appl. No.: |
15/639777 |
Filed: |
June 30, 2017 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
14491499 |
Sep 19, 2014 |
9697920 |
|
|
15639777 |
|
|
|
|
62028896 |
Jul 25, 2014 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2090/0481 20160201;
A61B 2090/0436 20160201; A61B 90/05 20160201; A61B 6/107 20130101;
G21F 1/02 20130101; G21F 3/00 20130101 |
International
Class: |
G21F 3/00 20060101
G21F003/00; A61B 90/00 20060101 A61B090/00; G21F 1/02 20060101
G21F001/02; A61B 6/10 20060101 A61B006/10 |
Claims
1. A radiation shielding device, comprising: a radiation shield,
comprising: a bottom portion including at least one notch
configured to receive a tubular work piece installed on a patient;
and a base comprising: a substructure attachable to an object; and
a retainer structure attachable to the radiation shield, wherein
the retainer structure comprises an adjustable coupling operable
between an unlocked condition in which an angular position of the
shield is adjustable to a user-selected position, and a locked
condition in which the angular position of the shield is
substantially fixed.
2. The radiation shielding device of claim 1, wherein the
adjustable coupling permits movement of the shield with at least
two degrees of freedom.
3. The radiation shielding device of claim 1, wherein the permitted
movement of the shield includes circumduction movement.
4. The radiation shielding device of claim 1, wherein the radiation
shield has a contoured shape providing a skewed reverse curve
profile along its height.
5. The radiation shielding device of claim 1, wherein the radiation
shield defines an outwardly projecting lip at the top of the shield
and a broad arcuate midsection.
6. The radiation shielding device of claim 5, wherein a radius of
curvature of the lip of the shield is about 5 mm to about 10 mm,
and the radius of curvature of the midsection is about 3 cm to
about 10 cm.
7. The radiation shielding device of claim 4, wherein the shield is
contoured widthwise in a convex orientation relative to a front
side of the shield.
8. The radiation shielding device of claim 1, wherein an overall
size of the shield is sufficient to cover an area where a
healthcare worker would position his/her hands during a medical
procedure.
9. The radiation shielding device of claim 8, wherein the radiation
shield has a density of about 1.5 g/cm.sup.3 to about 2.5
g/cm.sup.3, has volume of about 50 cm.sup.3 to about 100 cm.sup.3,
and has a mass of about 100 g to about 200 g.
10. The radiation shielding device of claim 8, wherein the
radiation shield has a width greater than a height and a
thickness.
11. The radiation shielding device of claim 8, wherein the shield
has a height of about 5 cm to about 25 cm and a maximum thickness
of about 1 mm to about 5 mm.
12. The radiation shielding device of claim 1, wherein the
radiation shield comprises a barium sulfate, and the radiation
shield has a nominal density of about 1.5 g/cm.sup.3 to about 2.5
g/cm.sup.3.
13. The radiation shielding device of claim 1, wherein the shield
comprises a plastic material infused with barium sulfate.
14. The radiation shielding device of claim 1, wherein the shield
comprises one or more sheets formed from a layer comprising barium
sulfate.
15. The radiation shielding device of claim 1, wherein the base is
configured to be coupled to a supporting object.
16. The radiation shield device of claim 15, wherein the base
comprises an adhesive layer for removably adhering the base to the
supporting object.
17. A radiation shielding device, comprising: a radiation shield,
wherein the shield has a height of about 5 cm to about 25 cm and a
maximum thickness of about 1 mm to about 5 mm, and a contoured
shape providing a skewed reverse curve profile along its height;
and a base comprising: a substructure attachable to an object; and
a retainer structure attachable to the radiation shield, wherein
the retainer structure comprises an adjustable coupling operable
between an unlocked condition in which an angular position of the
shield is adjustable to a user-selected position, and a locked
condition in which the angular position of the shield is
substantially fixed, and wherein the base comprises an adhesive
layer for removably adhering the base to a supporting object.
18. The radiation shielding device of claim 17, wherein the
permitted movement of the shield includes circumduction
movement.
19. The radiation shielding device of claim 18, wherein the
radiation shield defines an outwardly projecting lip at the top of
the shield and a broad arcuate midsection, and wherein a radius of
curvature of the lip of the shield is about 5 mm to about 10 mm,
and the radius of curvature of the midsection is about 3 cm to
about 10 cm.
20. The radiation shielding device of claim 19, wherein the
radiation shield has a width greater than a height and a thickness,
and wherein the shield has a height of about 5 cm to about 25 cm
and a maximum thickness of about 1 mm to about 5 mm.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. application Ser.
No. 14/491,499, filed Sep. 19, 2014, which claims the benefit of
U.S. Provisional Application Ser. No. 62/028,896, filed Jul. 25,
2014. The disclosure of the prior applications is considered part
of (and is incorporated by reference in) the disclosure of this
application.
TECHNICAL FIELD
[0002] This document relates to shielding devices, such as portable
radiation shielding devices for use in a medical environment.
BACKGROUND
[0003] In many situations, an interventional radiologist or other
healthcare worker (e.g., a physician, nurse, technician) may work
under a radiation field (e.g., from a fluoroscope, X-rays, other
imaging system, or the like) when treating a patient. Although
significant measures are often taken to minimize a patient's
exposure to radiation during medical procedures, the healthcare
worker implementing the procedure is often left exposed to the
radiation--at least to some degree--and such exposure is often
repeated for each new patient. For example, a healthcare worker's
hands can be exposed to radiation from radiation imaging machines
while inserting a central line in a patient (e.g., during a
fluoroscopic procedure). Physical barriers can be used to shield
the healthcare worker from radiation exposure, but often they are
bulky and disruptive to the healthcare worker during the
procedure.
SUMMARY
[0004] Some embodiments of a shielding device can be used to
provide protection for a healthcare worker (e.g., physician, nurse,
technician) during a medical procedure. In such circumstances, a
shield of the shielding device can be manipulated to a
user-selected orientation relative to a base, and optionally, the
shield may then locked in the selected position so as to provide a
radiation block for the healthcare worker's hands that would
otherwise be within the radiation field from the real-time X-Ray
imaging apparatus. In addition to the shielding device protecting
the healthcare worker's hands from X-Ray radiation, the shield can
further provide physical protection for the healthcare worker from
spatter of blood or other bodily fluids that may occur during the
procedure--all while allowing the healthcare worker to position his
or her hands in a non-disruptive and ergonomically effective
manner.
[0005] In some embodiments, a radiation shielding device may
include a radiation shield and a base. The base may include a
substructure attachable to an object, and a retainer structure
attachable to the radiation shield. Optionally, the base can
include a lock device that is actuatable to lock the shield in a
selected angular position after adjusting the shield device
relative to the base.
[0006] Particular embodiments described herein include a method of
shielding radiation during a medical procedure. The method may
include coupling a base of a radiation shielding device to an
object proximate a radiation source. The method may also include
coupling a shield of the radiation shielding device to the base.
Optionally, the angle of the shield relative to the base of the
shielding device and the object can be adjusted to a user-selected
orientation and then the shield can be locked in place at the
selected angular position. The method may further include shielding
radiation from the radiation source as the medical procedure is
conducted.
[0007] In some embodiments, a radiation shielding device includes a
radiation shield and a base, and the base may include a
substructure attachable to an object, and a retainer structure
attachable to the radiation shield. Optionally, the retainer
structure may include an adjustable coupling comprising first and
second semi-spherical yokes oriented perpendicular to one another
in an overlapping manner. Additionally or alternatively, the
retainer structure may optionally include an adjustable coupling
operable between an unlocked condition in which an angular position
of the shield is adjustable to a user-selected position, and a
locked condition in which the angular position of the shield is
substantially fixed. Additionally or alternatively, the radiation
shield may optionally have a contoured shape providing a skewed
reverse curve profile along its height. Additionally or
alternatively, the radiation shield may optionally comprise a
material having radiation shielding properties (such as barium
sulfate), and the radiation shield may have a density of about 1.5
g/cm.sup.3 to about 2.5 g/cm.sup.3.
[0008] In some embodiments, a radiation shielding device may
include a radiation shield having a height of about 5 cm to about
25 cm and a maximum thickness of about 1 mm to about 5 mm. Also,
the radiation shield can comprise a material having radiation
shielding properties. The device may also include a base that
includes a substructure attachable to an object, and a retainer
structure attachable to the radiation shield.
[0009] The details of several embodiments are set forth in the
accompanying drawings and the description below. Other features,
objects, and advantages of the invention will be apparent from the
description and drawings, and from the claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIGS. 1A-C are perspective front, perspective rear, and top
views of a shielding device in accordance with some
embodiments.
[0011] FIG. 2 is an exploded perspective view of the shielding
device of FIGS. 1A-C.
[0012] FIG. 3A is a cross-sectional view of the shielding device of
FIGS. 1A-C.
[0013] FIG. 3B is a cross-sectional view of a portion of the
shielding device of FIG. 3A.
[0014] FIGS. 4A-C are perspective rear, side, and rear views of the
shielding device of FIGS. 1A-C illustrated with the shield at an
angled non-orthogonal position relative to the base.
[0015] FIG. 5A is a perspective rear view of another shielding
device in accordance with some alternative embodiments.
[0016] FIG. 5B is an exploded perspective rear view of the
shielding device of FIG. 5A.
[0017] FIGS. 6A-B are side and perspective views of a shield device
in accordance with additional embodiments.
[0018] FIGS. 6C-D are side and perspective views of a shield device
in accordance with further embodiments.
[0019] FIGS. 6E-F are side and perspective views of a shield device
in accordance with additional embodiments.
[0020] FIGS. 6G-H are side and perspective views of a shield device
in accordance with further embodiments.
[0021] FIGS. 6I-J are side and perspective views of a shield device
in accordance with additional embodiments.
[0022] FIGS. 6K-L are side and perspective views of a shield device
in accordance with further embodiments.
[0023] FIG. 7 is an exploded perspective front view of a second
alternative shielding device in accordance with some
embodiments.
[0024] FIG. 8 is an exploded perspective front view of a third
alternative shielding device in accordance with some
embodiments.
[0025] FIG. 9 is a flow chart describing a process of using a
shielding device in accordance with some embodiments.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0026] Referring to FIGS. 1A-C, some embodiments of a shielding
device 100 can include a base 102 and a shield 104 coupled to the
base 102. The shielding device 100 can be used to provide
protection for a healthcare worker (e.g., physician, nurse,
technician) during a medical procedure. As one example, the base
102 of the shielding device 100 can be adhered to a patient's skin
positioned near the patient's liver when inserting a bile drain
using real-time X-Ray imaging. In such circumstances, the shield
104 can be manipulated to a user-selected orientation relative to
the base 102 and then locked in the selected position so as to
provide a radiation block for the healthcare worker's hands that
would otherwise be within the radiation field from the real-time
X-Ray imaging apparatus. In addition to the shielding device 100
protecting the healthcare worker's hands from X-Ray radiation, the
shield 104 can further provide physical protection for the
healthcare worker from spatter of blood or other bodily fluids that
may occur during the procedure--all while allowing the healthcare
worker to position his or her hands in a non-disruptive and
ergonomically effective manner.
[0027] In some applications, protecting portions of the healthcare
worker's body nearest to the source of radiation, such as the
worker hands, can be beneficial because radiation exposure
decreases based on the distance from the source. Thus, a healthcare
worker's hands, if not protected, may be exposed to nine times the
radiation to which his/her torso is exposed during an X-Ray imaging
procedure. In some applications, the shielding device 100 is
provided as a portable structure that can be transported to the
site of a medical procedure (e.g., an exam room or an operating
room) by the healthcare worker and disposed of at the conclusion of
the procedure to prevent the transmission of pathogens between
patients and/or healthcare workers.
[0028] As shown, the base 102 of the shielding device 100 includes
a substructure 106 and a retainer structure 108. During use of the
shielding device 100, the substructure 106 supports the base 102 on
the surface of an object (not shown) and the retainer structure 108
couples the base 102 to the shield 104. In various applications of
the shielding device 100, the supporting object may include a
portion of the patient's skin along an exposed body part of the
patient (e.g., a limb or a torso) or any other object that is
capable of firmly carrying the base 102 and the attached shield 104
(e.g., a table, a bed rail, or the like). In some applications, the
supporting object may include a portion of the healthcare worker's
body, e.g., a hand or an arm.
[0029] The construction of the substructure 106 provides sufficient
mechanical strength and stiffness for supporting the base 102 on
the surface of the object in a substantially fixed position during
use (e.g., as the shield 104 is being coupled to the base 102 or
otherwise manipulated by a healthcare worker). In this embodiment,
the substructure 106 includes a butterfly-shaped, generally flat
member having a circular central body 110 extended by opposing
oval-shaped wings 112. The central body 110 of the substructure 106
is attached to the retainer structure 108 (and, optionally, can be
continuous such that it extends under the entirety of the retainer
structure 108 (refer to FIG. 2)). The wings 112 provide additional
surface area for contacting the supporting object (e.g., so as to
more firmly adhere or otherwise attached with the patient's skin or
other supporting object). In some embodiments, the substructure 106
can include a compliant member capable of conforming to various
contours and corners of the supporting object. For example, in this
embodiment, the wings 112 can be bent out of plane to follow the
shape of the object. In some embodiments, the substructure 106 can
include a malleable wire frame to reinforce the compliant
member.
[0030] In some embodiments, the substructure 106 is fabricated from
one or more plastic materials capable of accepting an infusion of
radiation shielding material (e.g., material including barium,
lead, tungsten, tin, aluminum and/or any attenuating metal). In
some embodiments, the substructure 106 can include a laminated
multi-layer construction. For example, the substructure 106 can
include a skin-friendly underlayer (e.g., a foam layer) bonded to a
reinforcing overlayer (e.g., a flexible metal or plastic layer). In
some embodiments, the substructure 106 is fabricated from one or
more materials that are suitable for medical applications (e.g.,
biocompatible metallic and/or polymeric materials). For example,
the substructure 106 can be fabricated from a medical grade dense
foam sheet material having a thickness of about 1 millimeter to 2.5
centimeters. In some embodiments, a bottom surface 114 of the
substructure 106 can include an adhesive material suitable for
temporarily adhering the base 102 to the supporting object. The
adhesive can be a medical grade adhesive that is resistant to
water, blood, and other bodily fluids, and that is suitable for
adhering to the exterior of a targeted skin surface. In some
embodiments, the adhesive on the bottom surface 114 may initially
be covered by a removable sheet to expose the adhesive for use.
Various types of suitable attachment mechanisms can be used to
couple the substructure 106 to the supporting object. For example,
in some embodiments, the substructure can include a suction device
or an adjustable strap system to attach the substructure to the
object. In some embodiments, the substructure can be provided in
the form of a glove or a strap system wearable by the healthcare
worker while performing a medical procedure (e.g., a fluoroscopic
diagnostic procedure to evaluate for aspiration).
[0031] As noted above, the retainer structure 108 couples the base
102 to the shield 104 during use. In some embodiments, the retainer
structure 108 provides an adjustable coupling that permits movement
of the shield 104 with at least two degrees of freedom (and, in
some embodiments, three degrees of freedom). As such, the shield
can be positioned at numerous angles relative to the substructure
106 of the base 102 (and therefore the supporting object). In some
embodiments, the coupling of the retainer structure 108 can be
operated between an unlocked condition, where the angular position
of the shield 104 is adjustable to a user-selected position, and a
locked condition, where the angular position of the shield 104 is
fixed.
[0032] Referring to FIGS. 2, 3A and 3B, the retainer structure 108
includes a platform 116, a first yoke 118a, a second yoke 118b, a
pilot member 120, a clamp member 122, and a lock knob 124. The
platform 116 is a circular frame fixedly attached to the central
body 110 of the substructure 106. As shown, each of the first and
second yokes 118a, 118b is a semi-spherical segment having an
elongated slot 126a, 126b extending along the length of the
segment. The first and second yokes 118a, 118b are oriented
perpendicular to one another and positioned in an overlapping
manner, such that the slots 126a, 126b meet at an intersection
point of the yokes 118a, 118b. The diametrically opposed ends 128a,
128b of the first and second yokes 118a, 118b are rotationally
mounted to the platform 116 in a fixed position. Thus, the first
yoke 118a is constrained to pivotal movement in a first direction
130a with respect to the platform 116; and the second yoke 118b is
pivotally movable in a second direction 130b that is perpendicular
to the first direction 130a.
[0033] Referring to FIG. 3B, the pilot member 120 includes a
central shaft 132 and a convex flange 134 extending radially
outward to surround the shaft 132. The shaft 132 defines a central
threaded bore 136. The convex flange 134 provides a sloping upper
flange surface with curvature to accommodate the semi-spherical
shape of the first and second yokes 118a, 118b. The pilot member
120 is located with the convex flange 134 positioned beneath the
first and second yokes 118a, 118b and an upper portion of the shaft
132 projecting through the intersection point of the slots 126a,
126b. The clamp member 122 is coupled with the pilot member 120 to
retain the pilot member 120 at the intersection point of the slots
126a, 126b. The clamp member 122 includes a central opening 138 and
a concave flange 135 extending radially outward to surround the
opening 138. The concave flange 135 provides a sloping lower flange
surface with curvature to accommodate the semi-spherical shape of
the first and second yokes 118a, 118b. The clamp member 122 is
located with the concave flange 135 positioned above the first and
second yokes 118a, 118b. The upper portion of the shaft 132 of the
pilot member 120 projects longitudinally into the opening 138 of
the clamp member 122. To couple the clamp member 122 to the pilot
member 120, a radial lip 139 at the upper end of the shaft 132 of
the pilot member 120 provides a snap engagement with a radial
shoulder 140 in the opening 138 of the clamp member 122.
[0034] Still referring to FIG. 3B, the lock knob 124 includes a
shank 141 and head 142. The head 142 includes three flanges 144a,
144b, 144c, extending radially outward to surround a cylindrical
body 143 coaxially aligned with the shank 141. The flanges 144a,
144b, 144c are substantially flat and spaced apart from one another
longitudinally along the body 143. A lower portion of the shank 141
is threaded. The shank 141 projects longitudinally into the opening
138 of the clamp member 122 and the central bore of the shaft 132
of the pilot member 120. The threads of the central bore of the
shaft 132 of the pilot member 120 mate with the threads at the
lower portion of the shank 141 of the lock knob 124. Thus, the lock
knob 124 is telescopically coupled with the pilot member 120 and
the clamp member 122.
[0035] The lock knob 124 is movable with two degrees of freedom
relative to the substructure 106 in the directions 130a, 130b
permitted by the first and second yokes 118a, 118b. Movement of the
lock knob 124 causes identical movement of the coupled pilot member
120. Movement of the pilot member 120 driven by the lock knob 124
causes movement by the first and second yokes 118a, 118b as the
shaft 132 of the pilot member 120 interacts with the slots 126a,
126b. For example, as the pilot member 120 moves through the slot
126a of the first yoke 118b, the second yoke 118b is pulled by the
shaft 132 to pivot in the second direction 130b; and vice versa.
The length of the slot 126a, 126b in each respective yoke 118a,
118b bounds the movement of the pilot member 120, and therefore the
lock knob 124. Freedom in the pivoting directions 130a, 130b
permits the lock knob 124 to execute 360.degree. circumduction
movement resembling the conical movement of a joystick.
[0036] Still referring to FIG. 3B, the shield 104 is attached to
the lock knob 124 by two grippers 146a, 146b that extend outward
from the rear side 148 of the shield 104 to engage with the head
142 of the lock knob 124. Each of the grippers 146a, 146b includes
a pair of opposing fingers formed to reach between the flanges
144b, 114c to grip the body 143 of the head 142. As shown, the
first gripper 146a is positioned between the flanges 144b and 144c
of the lock knob 124; and the second gripper 146b is positioned
below the flange 144c. In some embodiments, the grippers 146a, 146b
loosely grip the body 143 to allow 360.degree. of rotational
movement 149 in a direction about a central axis of the lock knob
124. The shield 104 can also be tilted at various angles relative
to the substructure 106 by circumduction movement of the lock knob
124. FIGS. 4A-C illustrate the shield 104 tilted at an angle that
is forward and sideways relative to the stationary substructure 106
of the base 102.
[0037] In some embodiments, the previously described movements of
the shield 104 are permitted while the retainer structure 108 is in
an unlocked condition, and prevented while the retainer structure
108 is in a locked condition. In this embodiment, the retainer
structure 108 can be operated from the unlocked condition to the
locked condition by adjusting the lock knob 124. For example, the
lock knob 124 can be rotated (e.g., clockwise or counter clockwise)
to telescopically advance the shank 141 downward through the shaft
132 of the pilot member 120 via the mating threads. Downward
movement of the lock knob 124 relative to the pilot member 120 and
the clamp member 122 urges the bottommost gripper 146b of the
shield 104 toward the rim 150 of the opening 138 of the clamp
member 122. As the lock knob 124 continues to advance downward, the
clamp member 122 is pressed down against the first and second yokes
118a, 118b. The first and second yokes 118a, 118b are clamped
between the concave flange 135 of the clamp member 122 and the
convex flange 134 of the pilot member 120, and therefore held in a
fixed position by frictional forces. With the first and second
yokes 118a, 118b held stationary, circumduction movement of the
lock knob 124 is prevented. Likewise, the first gripper 146a
becomes clamped between the flanges 144b and 144c of the lock knob
124; and the second gripper 146b becomes clamped between the
flanges 144c of the lock knob 124 and the rim 140 of the clamp
member 122. Thus, frictional forces also prevent rotation of the
shield 104 about the central axis of the lock knob 124. As should
be understood from FIGS. 1A-4C, the shield 104 can be repeatedly
operated between the locked condition and the unlocked condition
(by adjusting the lock knob 124) so that the shield 104 is locked
into different user-selected orientations relative to the base 102
throughout a medical procedure.
[0038] As noted above, the shield 104 can also act as a physical
barrier to protect the healthcare worker. Referring to back FIGS.
1A-C, the outer edges of the shield 104 define an overall size of
the shield 104--including a height "H," a width "W"--and a
thickness "T" (FIG. 1A). In some embodiments, the shield 104 is
provided having a contoured shape. In some embodiments, the
contoured shape of the shield 104 can provide enhanced splash and
spatter protection to inhibit liquids (e.g., blood and other bodily
fluids) from contacting the healthcare worker during a medical
procedure while simultaneously providing an ergonomic space for the
healthcare worker to position his/her hands during use. In this
embodiment, the shield 104 has a skewed reverse curve profile along
its height, defining a short outwardly projecting lip 152 at the
top of the shield 104 and an arcuate midsection 154 (FIG. 1B).
During use, the shield 104 can be positioned with the front side
156 of the shield 104 facing the healthcare worker and the rear
side 158 of the shield 104 facing a radiation source. In this
orientation, the lip 152 and the midsection 154 are directed away
from the healthcare worker to provide liquid splash and spatter
protection. Further, because the midsection 154 of the shield 104
bows outward away from the healthcare worker, there is additional
space for the healthcare worker to maneuver his/her hands (e.g., to
perform a medical procedure and/or to adjust the lock knob 124). In
this embodiment, the shield 104 is also contoured widthwise (convex
from the front side 156 of the shield 104) to curve around the
space where the healthcare worker is expected to position his/her
hands (FIG. 1C). This configuration may provide additional
protection for the healthcare worker around the space where the
healthcare worker positions his/her hands. Notches 160 are provided
near the bottom of the shield 104 to receive a tubular work piece
(e.g., a catheter) installed on a patient (FIG. 1A).
[0039] In some embodiments, the shield 104 is capable of
attenuating or deflecting the flux of electromagnetic radiation
(e.g., X-Ray radiation) directed at the shield 104 by a radiation
source (not shown). The effectiveness of the shield 104 directly
corresponds to the radiation shielding properties of the materials
used to fabricate the shield 104. The required radiation shielding
effectiveness of the shield 104 may vary across different
applications. For example, a less effective shield may be used
applications where the healthcare worker is farther away from the
radiation source, and vice versa. In some embodiments, the shield
104 can include one or more layers of radiation shielding material
(e.g. a sheet of lead foil). For example, such radiation shielding
layers can be sandwiched between plastic or metal reinforcement
layers. In some embodiments, the shield 104 can be fabricated from
a plastic material infused with suitable radiation shielding
materials (e.g., materials including barium, lead, tungsten, tin,
aluminum and/or any attenuating metal).
[0040] As described above, the shield 104 is carried by various
components of the retainer structure 108. So, as practical matter,
a tolerable weight of the shield 104 may be affected by the load
bearing capacity of the retainer structure 108. Further, in
applications where, for example, the shielding device 100 is
supported directly on a body part of the patient, the tolerable
weight of the shield 104 may be selected so as to reduce excessive
strain on the patient's skin or other body part.
[0041] Factors that may be considered in designing a shield 104 of
suitable weight include the volume of the shield 104 and the
density of the fabricating materials. The weight of the shield 104
increases with increasing volume and/or density. The volume of the
shield 104 varies according to its surface area and thickness. The
volume of the shield 104 can be varied without affecting the
overall size (i.e., the height "H," the width "W"), for example, by
adjusting the degree of curvature of the contours (e.g., the lip
152, the midsection 154, and the widthwise contour) and/or by
adjusting the thickness of the shield 104. In some applications, it
may be advantageous to maintain a relative large overall size of
the shield 104 to provide adequate protection to the healthcare
worker. The density of the shield 104 can vary based on the
specific type and amount of radiation shielding material used. For
example, barium sulfate is approximately two-thirds less dense than
lead, and therefore would provide a less dense, and lighter, shield
if all other conditions (e.g., the volume of the shield and/or the
other fabrication materials) are equal. As such, in some
embodiments, the shield may comprise a material such as barium
sulfate or another heavy metal material suitable for reducing or
blocking radiation exposure.
[0042] In this embodiment, the volume of the shield is about 50
cm.sup.3 to about 100 cm.sup.3 (preferably about 71 cm.sup.3 in the
depicted example), and is fabricated from a plastic material
infused with barium sulfate, which provides a shield density of
about 1.5 g/cm.sup.3 to about 2.5 g/cm.sup.3 (preferably about 2.0
g/cm' in the depicted example). The height of the shield is about 5
cm to about 25 cm (preferably about 15 cm in the depicted example);
the mass of the shield is about 100 g to about 200 g (preferably
about 142 g in the depicted example); the thickness of the shield
is about 1 mm to about 5 mm (preferably about 2.3 mm in the
depicted example); the radius of curvature of the lip of the shield
is about 5 mm to about 10 mm (preferably about 7.7 mm in the
depicted example); the radius of curvature of the midsection of the
shield is about 3 cm to about 10 cm (preferably about 5.1 cm in the
depicted example); and the radius of curvature of the widthwise
contour is about 10 cm to about 25 cm (preferably about 17.7 cm in
the depicted example). In this embodiment, the shield weighs about
0.1 lbs to about 0.5 lbs (preferably about 0.3 lbs in the depicted
example).
[0043] FIGS. 5A and 5B depict a shielding device 500 that is
similar to the shielding device 100, including a base 502 and a
shield 504 coupled to the base 502. In this embodiment, the
contours of the shield 504 are significantly more pronounced
compared to the shield 104. In particular, the lip 552 and the
midsection 554 have a significantly greater degree of curvature,
creating a greater surface area and therefore a greater volume
(assuming constant overall size and thickness). Thus, if all other
conditions are equal, the shield 504 would have a greater weight
than the shield 104.
[0044] The base 502 includes a substructure 506 and a retainer
structure 508. In this embodiment, the substructure 506 includes
four radial legs 512. In some embodiments, the legs 512 are
flexible and can be bent out of plane to follow the shape of a
supporting object. The retainer structure 508 includes a platform
516, a first yoke 518a, a second yoke 518b, a pilot member 520, a
clamp member 522, and a lock knob 524. Generally, these components
may be assembled to function generally as described above. However,
in this embodiment, the shield 504 is coupled to the lock knob 524
by a coupling pin 562. In particular, the lock knob 524 includes a
central bore for receiving the lower end of the coupling pin 562;
and the upper end of the coupling pin 562 is received by a collar
housing 564 on the rear side 548 of the shield 504.
[0045] FIGS. 6A-6L depict various example shields 604a-604f that
may be suitable for use in various embodiments of a suitable
shielding device. As described above, the overall shape and size,
as well as the contours of the various shields 604a-604f may affect
the volume, and therefore the weight, of the respective shield for
a given density of the fabricating materials. The configuration of
the shield (e.g., the size, shape, contour, thickness, density) may
vary across different implementations based on the desired
application. For example, applications requiring protection from a
relative high degree of scatter radiation may involve a shield that
is relatively large in overall size to provide broad coverage. In
this case, the weight of the shield can be maintained within
tolerable limits, for example, by fabricating the shield with a
less dense material and/or by fabricating the shield with less
severe counters and/or relatively low thickness.
[0046] FIG. 7 depicts yet another shielding device 700 including a
base 702 and a shield 704 coupled to the base 702. The shield 704
is similar to the shield 104, having a contoured shape defining a
reverse curve profile including an outwardly projecting lip 752 and
an arcuate midsection 754. The shield 704 is also contoured
widthwise, appearing convex from the front side 756 of the shield
704. As noted above, in some embodiments, the contoured shape of
the shield 704 can provide splash and spatter protection to inhibit
liquids from contacting the healthcare worker. Further, in some
embodiments, the contoured shape of the shield 704 can provide an
ergonomic space for the healthcare worker to position his/her hands
during use.
[0047] The base 702 includes a substructure 706 and a retainer
structure 708. As in previous embodiments, during use of the
shielding device 700, the substructure 706 supports the base 702 on
the surface of an object (not shown) and the retainer structure 708
couples the base 702 to the shield 704. In this embodiment, the
substructure 706 includes a butterfly-shaped member having opposing
tapered oblong wings 712 connected by a narrow body 710. In some
embodiments, the substructure 706 can include a compliant member
capable of conforming to various contours and corners of the
supporting object. For example, in this embodiment, the wings 712
can be bent out of plane to follow the shape of the object. In some
embodiments, the substructure 706 can include a malleable wire
frame to reinforce the compliant member. In some embodiments, the
substructure 706 is fabricated from one or more materials that are
suitable for medical applications (e.g., biocompatible metallic
and/or polymeric materials). In some embodiments, a bottom surface
714 of the substructure 706 can include an adhesive material
suitable for temporarily adhering the base 702 to the supporting
object. The adhesive can be a medical grade adhesive resistant to
water, blood, and other bodily fluids, and releasable by alcohol
(e.g., ethyl alcohol). In some embodiments, the substructure 706 is
fabricated from one or more materials capable of accepting an
infusion of radiation shielding material (e.g., material including
barium, lead, tungsten, tin, aluminum and/or any attenuating
metal). In some embodiments, the substructure 706 can include a
laminated multi-layer construction. For example, the substructure
706 can include a skin-friendly underlayer (e.g., a foam layer)
bonded to a reinforcing overlayer (e.g., a flexible metal or
plastic layer).
[0048] As shown, the substructure 706 further includes a plurality
of apertures 766 that extend through the material to expose the
supporting object. During use, a healthcare worker can suture the
substructure 706 to the object through one or more of the apertures
766, for example, if the adhesive on the bottom surface 714 is
unsuitable of ineffective for the particular applications. As one
example, the healthcare worker can suture the substructure to a
patient's skin through the apertures 766 if the patient is allergic
to the adhesive.
[0049] The retainer structure 708 is attached to the substructure
706 across the narrow body 710 between the wings 712. The retainer
structure 708 can be attached to a coupling member 768 provided at
the bottom end of the shield 704 to couple the shield 704 to the
base 702. In some embodiments, the coupling member 768 can be
snap-fit or press-fit to the retainer structure 708 to secure the
shield 704 to the base 702. In this embodiment, the retainer
structure 708 includes a slot 770 appropriately shaped and sized
for receiving a tubular work piece (e.g., a catheter, a drain, an
intravenous line) and a lock mechanism 772 for securing the work
piece in the slot 770. For example, if shielding device 700 is
supported on an object proximate a catheter exit site, the catheter
can be positioned lengthwise in the slot 770 and held in place by
the lock mechanism 772 to inhibit the unintentional release of the
catheter from the patient. The slot 770 and the lock mechanism 772
can be designed to accommodate a particular size or a range of
sizes. In some embodiments, the slot 770 and the lock mechanism 772
are designed to accommodate tubular work pieces in the range of
about 4 French (1.33 mm) to about 12 French (4 mm). In some
embodiments, the lock mechanism 772 includes a spring-loaded clamp
(not shown) that grips the work piece with sufficient force to
inhibit unintentional release of the work piece. In some
embodiments, the work piece can be secured and/or released from the
lock mechanism 772 without removing the shield 704 from the base
702, which may allow the healthcare worker to adjust the work piece
during a medical procedure without being exposed to radiation. In
some embodiments, a shielding plug (not shown) can be installed on
the retainer structure 708 to block fluid and/or radiation from
penetrating through the slot 770 and the lock mechanism 772 when no
work piece is present.
[0050] FIG. 8 depicts a shielding device 800 that is similar to the
shielding device 700, including a base 802 and a shield 804 coupled
to the base 802 In this embodiment, the shield 804 is mounted to a
coupling member 868 by a ball and socket joint 874. The coupling
member 868 attaches the shield 804 to the retainer structure 808 of
the base 802. The ball and socket joint 874 permits movement of the
shield 804 relative to the base 802 within at least two degrees of
freedom. In this embodiment, the ball and socket joint 874 permits
rotational movement 876 of the shield 804 about an axis 878
substantially perpendicular to the base 802, and articulating
movement 880 about an axis 882 substantially perpendicular to the
axis of rotation. As shown, the articulating movement 880 tilts the
shield 804 forward and backward relative to the base 802. In some
embodiments, the ball and socket joint 874 permits 360.degree. of
rotation of the shield 804. In some embodiments, the ball and
socket joint 874 limits articulation of the shield 804 to plus or
minus 30.degree..
[0051] Referring now to FIG. 9, a suitable shielding device (e.g.,
shielding device 100, 500, 700 and 800) can be operated (e.g., by a
healthcare worker) to implement a process 900 of shielding
radiation and/or liquid from a healthcare worker during a medical
procedure. Note that the process 900 does not require the
particular order of operations shown in FIG. 9 and described below
to achieve desirable results. In addition, other operations may be
provided, or eliminated, to the process 900 without departing from
the scope of the present disclosure.
[0052] In operation 910, a base of the shielding device can be
coupled to an object. The object may include an exposed body part
of a patient or any other structure that is capable of carrying the
base and an attached shield. In some embodiments, the base can be
coupled to the object by an adhesive layer on a bottom surface of
the base. In some embodiments, the base can be sutured to the
object.
[0053] In operation 920, a shield of the shielding device can be
coupled to the base. For example, the shield can be attached to a
retainer structure of the base. In some embodiments, the retainer
structure may include a lock knob and the rear side of the shield
can include grippers that engage the head of the lock knob (e.g.,
shielding device 100). In some embodiments, the shield can be
coupled to the lock knob by a coupling pin (e.g., shielding device
500). The lower end of the coupling pin is received in a central
bore of the lock knob, and the upper end of the coupling pin is
received by a collar housing on the rear side of the shield. In
some embodiments, a coupling member at the bottom end of the shield
can be press-fit or snap-fit to the retainer structure (e.g.,
shielding device 700). In some embodiments, a malleable stem or a
clasp can be used to couple the shield to the base.
[0054] Optionally, in operation 930, the angle of the shield
relative to the base of the shielding device and the object can be
adjusted. In some embodiments, the coupling between the shield and
the base permits movement of the shield within three degrees of
freedom relative to the base (e.g., shielding device 100). In this
case, the angle of the shield relative to the base can be adjusted
by rotation and circumduction movement of the shield relative to
the base. In some embodiments, the coupling permits movement of the
shield within at least two degrees of freedom (e.g., shielding
device 800). In this case, the angle of the shield relative to the
base can be adjusted by rotation and articulation movement of the
shield relative to the base. Optionally, in operation 940, the
shield can be locked in place at the angle. For example, in
embodiments where the shield includes a lock knob threaded to a
pilot member (e.g., shielding device 100 and 500), the lock knob
can be rotated to clamp the shield in place.
[0055] In operation 950, the medical procedure can be conducted
while the shield inhibits radiation and/or liquid from contacting
the healthcare worker. In some embodiments, the shield can be
fabricated from one or more suitable radiation shielding materials.
In some embodiments, the shield can be appropriately contoured to
block liquid splash and splatter that may occur during the medical
procedure. Optionally, in operation 960, the shielding device is
removed from the supporting object and disposed of, for example, to
prevent the spreading of pathogens between patients and/or
healthcare workers.
[0056] The use of terminology such as "front," "rear," "top,"
"bottom," "over," "above," and "below" throughout the specification
and claims is for describing the relative positions of various
components of the system and other elements described herein.
Similarly, the use of any horizontal or vertical terms to describe
elements is for describing relative orientations of the various
components of the system and other elements described herein.
Unless otherwise stated explicitly, the use of such terminology
does not imply a particular position or orientation of the system
or any other components relative to the direction of the Earth
gravitational force, or the Earth ground surface, or other
particular position or orientation that the system other elements
may be placed in during operation, manufacturing, and
transportation.
[0057] A number of embodiments of the invention have been
described. Nevertheless, it will be understood that various
modifications may be made without departing from the scope of the
invention.
* * * * *