U.S. patent application number 14/961822 was filed with the patent office on 2016-06-09 for multimodality medical procedure mattress-based device.
This patent application is currently assigned to Egg Medical, Inc.. The applicant listed for this patent is Egg Medical, Inc.. Invention is credited to John P. Gainor, Uma S. Valeti, Robert F. Wilson.
Application Number | 20160158082 14/961822 |
Document ID | / |
Family ID | 56092685 |
Filed Date | 2016-06-09 |
United States Patent
Application |
20160158082 |
Kind Code |
A1 |
Gainor; John P. ; et
al. |
June 9, 2016 |
Multimodality Medical Procedure Mattress-Based Device
Abstract
A mattress system is provided that is optimized for the hospital
setting and includes a guiderail system that accepts a variety of
accessories for attachment thereto. The guiderail system may have
integrated data lines, power lines, gas lines, and/or fluid lines.
Also provided are radioabsorbant shields, trays and other
components designed for optimal use with the mattress system.
Inventors: |
Gainor; John P.; (Mendota
Heights, MN) ; Wilson; Robert F.; (Roseville, MN)
; Valeti; Uma S.; (St. Paul, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Egg Medical, Inc. |
Roseville |
MN |
US |
|
|
Assignee: |
Egg Medical, Inc.
Roseville
MN
|
Family ID: |
56092685 |
Appl. No.: |
14/961822 |
Filed: |
December 7, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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62088495 |
Dec 5, 2014 |
|
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62240409 |
Oct 12, 2015 |
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Current U.S.
Class: |
5/690 ;
250/515.1 |
Current CPC
Class: |
A61G 7/05 20130101; A61B
6/102 20130101; A61G 7/075 20130101; A61G 7/0503 20130101; A61G
7/072 20130101; A61G 1/013 20130101; A61G 12/008 20130101; A61G
13/101 20130101; A61G 13/107 20130101; A61B 6/503 20130101; A61B
6/487 20130101; A61G 2210/90 20130101; A61M 5/14 20130101; A61B
6/4423 20130101; A61G 7/0524 20161101; A61G 2210/50 20130101; A61G
13/121 20130101; A61H 31/006 20130101; A61G 2205/60 20130101; A61B
6/0407 20130101; A61B 6/0492 20130101; A61B 6/107 20130101; A61G
1/01 20130101 |
International
Class: |
A61G 7/05 20060101
A61G007/05; A61B 6/04 20060101 A61B006/04; A61B 6/10 20060101
A61B006/10; A61G 7/075 20060101 A61G007/075 |
Claims
1. A mattress comprising: a soft comfort component that complies
with a patient's body when the patient is lying on the mattress; a
shell surrounding at least a lower surface of the comfort component
and integral therewith, said shell being more rigid than the soft
comfort component; wherein the shell includes extents that are
connected to said comfort component such that contaminants do not
accumulate between said shell and said comfort component a
guiderail system attached to the shell, the guiderail system
including a guiderail providing an attachment surface usable to
attach accessories to said guiderail.
2. The mattress of claim 1 wherein said shell surrounds a lower
surface and at least a portion of at least one side surface of said
soft comfort component.
3. The mattress of claim 1 wherein said soft comfort component
includes a chest portion of increased stiffness to facilitate chest
support during application of resuscitative chest compressions.
4. The mattress of claim 1 wherein said guiderail system further
includes electrical lines integrated into said guiderails.
5. The mattress of claim 1 wherein said guiderail system further
includes data lines integrated into said guiderails.
6. The mattress of claim 1 wherein said guiderail system further
includes gas lines integrated into said guiderails.
7. A mattress system for use in a hospital comprising: a mattress
comprising: a soft comfort component that complies with a patient's
body when the patient is lying on the mattress; a shell surrounding
at least a lower surface of the comfort component and integral
therewith, said shell being more rigid than the soft comfort
component; wherein the shell includes extents that are connected to
said comfort component such that contaminants do not accumulate
between said shell and said comfort component a guiderail system
attached to the shell, the guiderail system including a guiderail
providing an attachment surface usable to attach accessories to
said guiderail; a kit of components, said kit including at least
one of the following components: arm rests; radiation shield; a
table; a wrist holder; a clip for holding elongate components such
as guidewires and catheters; wherein said at least one component in
said kit includes a latch and release mechanism slidably attachable
to said guiderail such that, once attached to said guiderail, said
component may be slid along said attachment surface to a desired
location.
8. The mattress system of claim 7 wherein said shell surrounds a
lower surface and at least a portion of at least one side surface
of said soft comfort component.
9. The mattress system of claim 7 wherein said soft comfort
component includes a chest portion of increased stiffness to
facilitate chest support during application of resuscitative chest
compressions.
10. The mattress system of claim 7 wherein said guiderail system
further includes electrical lines integrated into said
guiderails.
11. The mattress system of claim 7 wherein said guiderail system
further includes data lines integrated into said guiderails.
12. The mattress system of claim 7 wherein said guiderail system
further includes gas lines integrated into said guiderails.
13. The mattress system of claim 7 wherein said radiation shield
includes a lateral unit that extends vertically from said latch and
release mechanism when said latch and release mechanism is attached
to said guiderail.
14. The mattress system of claim 13 wherein said radiate shield
further includes an upper unit and a lower unit attached to said
upper unit, wherein at least one of said upper and lower units are
attached to said lateral unit.
15. The mattress system of claim 14 wherein said upper unit pivots
vertically about said lower unit.
16. The mattress system of claim 14 wherein said upper unit
includes vertical separations, thereby forming a plurality of
vertical segments that may be positioned independently of each
other.
17. A radioabsorbant shield comprising: a lower unit including a
cutout portion to conform to a patient lying under the shield; an
upper unit attached to a top of the lower unit; and, a
substantially vertical lateral unit attached to a side of at least
one of the upper and lower units and including an attachment
mechanism for attachment to a bed; wherein said upper unit rotates
vertically relative to said lower unit.
18. The radioabsorbant shield of claim 17 wherein said upper unit
includes vertical separations, thereby forming a plurality of
vertical segments that may be positioned independently of each
other.
19. The radioabsorbant shield of claim 17 wherein said upper unit
is stiffer than said lower unit.
20. The radioabsorbant shield of claim 17 wherein said lateral unit
comprises a cutout shaped to accommodate an arm of the patient.
Description
RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Patent
Application Ser. No. 62/008,495 filed Dec. 5, 2014 entitled A
Multimodality Medical Procedure Mattress-Based Device, and to U.S.
Provisional Application Ser. No. 62/240,409 filed Oct. 12, 2015
entitled Radioabsorbent Assemblies, both of which are hereby
incorporated herein by reference in their entireties.
FIELD OF THE INVENTION
[0002] The present application relates generally to the use of
devices during medical procedures (e.g. heart catheterization,
surgery, medical imaging) in which a patient lies on a surface.
BACKGROUND OF THE INVENTION
[0003] Patient tables are used in a wide variety of settings for
medical procedures and for patient transport. In most or all of
these procedures, the patients lie upon a mattress that rests atop
the patient table and typically consists of a soft pad that is
contained within a flexible cover. While on the mattress, the
patient is often connected to any one of a number of monitors that
may be used to monitor pulse oximetry, blood pressure,
electrocardiogram tracings, heart rate or other physiologic
information. In addition, medical treatment devices, such as
intravenous infusion pumps and cardiopulmonary resuscitation
devices are connected to the patient on the mattress and attached
to surrounding structures, such as a gurney or free standing
pole.
[0004] The intention of the mattress design is to provide a
durable, easily cleanable, relatively comfortable location for the
patient to lie through the procedure with a shape that matches the
table upon which it is to be used. This type of mattress is present
on all patient tables throughout the hospital. While providing some
modicum of patient comfort, this mattress is not designed with any
additional features to provide value to the patient or clinician.
In fact, patient mattresses are frequently surrounded by a variety
of monitoring and therapeutic devices that are attached to the
patient in one way or another. This results in a confusing array of
cables, tubes, power sources, gas sources (such as oxygen), and
displays. All of these require attachment to the patient or travel
with the patient, creating a complex web of devices around and
connected to the patient. These connections are prone to
inadvertent mis-application and disconnection. Moreover, the need
for a battery power supply in some devices increases weight and
creates a need for recharging of multiple devices.
[0005] Many of the ancillary medical devices referred to above are
attached to a table or gurney that supports the patient mattress.
X-ray tables with rails that support patient mattresses have been
developed (e.g. Philips Allura Centron table) and rail systems for
stretchers have been described (application Ser. Nos. 12/107,730,
11/784,994 [lapsed], Ser. No. 12/651,601). The rails attached to
the table prevent patient movement without moving from the table
rails all ancillary equipment attached to the patient. That impedes
patient transfer to a bed and often leaves the patient unmonitored
while electrodes are reattached.
[0006] Support structures within mattresses have been described,
but these do not protrude from the mattress, are not intended to be
attached to medical devices, and do not carry power or data
conductors, or gas tubing (U.S. Pat. No. 8,984,690, US 763442, U.S.
Pat. No. 4,676,687).
[0007] Mattresses with flexible covering to aid sliding and
evacuation of patients from hazardous environments have also been
described (PCT/IB2011/000190, PCT/IB2011/003057, U.S. Ser. No.
13/452,079, U.S. Ser. No. 12/968,840, U.S. Ser. No. 11/617,061), as
well as ones with integral spinal protection boards within the
mattress to stabilize the spinal cord during transport and straps
to stabilize the patient within the evacuation apparatus. While
helpful for evacuation of patients, these products do not support
ancillary medical equipment such as pumps, monitoring devices, or
radiation shielding.
[0008] Stith described a life support bed where the medical
equipment needed for life support reside on the carriage of the bed
(U.S. Pat. No. 4,584,989). This device obviously could not be
easily transported or used for x-ray imaging.
[0009] In the medical procedure environment, the mattress and
associated patient table are two of many pieces of equipment
commonly used. Often times, there are monitors for
electrocardiogram tracings, pulse oximetry, blood pressure and
other purposes. For each of these monitors, there are associated
cables or leads used to connect to the patient. These cables often
become entangled and there is always a risk that leads are
inappropriately managed or connected to the patient. Challenges
with cable management can lead to procedural delays, entanglement
with other devices, and potential patient misdiagnosis.
[0010] Medical procedures are performed often on patients lying
horizontally on a mattress, such as an operating table. Ancillary
equipment such as intravenous pumps, control consoles and imaging
displays are often attached to a side rail on the operating table
or bed frame. These rails are composed of metal and are configured
to allow the attachment of a clamp or locking mechanism to fix the
equipment to the rail. One problem with this method of attaching
medical equipment to tables is that the table is usually fixed to a
rigid structure such as an x-ray unit, stretcher, or large bed.
Therefore, when patients are moved, the entire set of control
devices and other medical devices attached to the patient must to
detached and reattached to another bed structure or simply held by
a caregiver or the patient. In addition, many of the devices
attached to the rails require electrical power, connections to
other devices, or pressurized gas. This creates a clutter of wires
and tubes around the bed and also may impede efficient patient
transfer from one area to another.
[0011] Another aspect of a patient mattress is the fact that the
mattress must be thoroughly cleaned after each use. Concerns of
viral or bacterial transmission from patient to patient necessitate
an extensive cleaning process that includes manual spraying and
wiping of all patient surfaces. Following that process, other
potential disinfecting steps such as UV light or other sterilants
may be used in an attempt to reduce the risk of contamination and
disease transmission.
[0012] In the instance of a patient table used in an interventional
catheterization laboratory, there are additional aspects to the use
of the table and mattress. Arm boards are commonly used to support
the arms of the patient, both with standard arm boards during a
typical interventional procedure as well as with custom arm boards
designed to manage the arm during a radial artery access procedure,
in which the radial artery of the arm is accessed for
catheterization. The current state of the art with these boards is
simply to slide a polymeric sheet under the back of the patient to
stabilize the board, which cantilevers over the edge of the
mattress to support the arms. This can be a difficult maneuver to
insert the board, and the rigid board directly beneath the back and
shoulders of the patient may be uncomfortable.
[0013] The patient's wrist can be placed in any number of support
devices that lay on the arm board. These support devices generally
extend the wrist to provide better access to the radial artery. The
disadvantage is that the support devices must themselves be secured
to the arm board. In addition, procedures are usually performed
with the physician on the patient's right side. Access to the
patient's left arm for radial or brachial artery access to
difficult. Typically, the entire operating team has to move to the
patients left side and the room monitors (for example, x-ray and
physiologic monitoring) must be moved to the opposite side. As a
result, many surgeons have the patient drape their left arm across
their abdomen in order to access the left arm arteries from the
patient's right side. In this position, the surgeon's exposure to
x-ray increases significantly. A number of devices have been
developed to support the left arm in this position, but none have
integrated x-ray shielding.
[0014] In addition to the discomfort to the patient, there is risk
during radiographic procedures to the physician and cath lab staff
due to radiation exposure. The fluoroscopy unit that provides
imaging during the procedure emits x-rays that pass through the
patient with the intent of reaching the image intensifier for the
image to be transferred to the monitor. However, significant
portions of the radiation intended for imaging are scattered by
interaction with the patient and spread around the cath lab. Some
of this x-ray radiation is ultimately absorbed by the physician and
staff, increasing their overall radiation exposure.
[0015] Radiation protection during medical procedures requiring
x-rays or other ionizing radiation is a major health concern for
health care workers (HCW). There are numerous methods of shielding
the HCW from radiation. Commonly used methods include the use of
flat, inflexible, clear or opaque shields impregnated or covered
with lead or lead equivalent materials. These are cumbersome to
operate and require constant movement by the HCW to shield
themselves from radiation. Frequently, they also do not conform to
the patient's body habitus and contours. In addition, shields often
get in the way of adequate fluoroscopic visualization of the
patient or key areas of the patient that require easy access or
monitoring. Another major impediment of existing methods is that
the HCW has to move these heavy equipment manually and also conform
their bodies to visualize around the impediments caused by the
existing devices. This is a major cause for musculoskeletal
morbidity of the HCW resulting in chronic neck, back injuries.
Consequently, it is common for the HCW to sacrifice radiation
protection for better visualization as well as better ergonomics by
moving the current shields out of the way or positioning them in a
markedly sub-optimal protection position. In addition, many times
the HCW forgets to move the shields for adequate protection.
[0016] Systems of radiation shielding have been described. These
systems, however, employ extensive heavy shields or encase the
operator in a restrictive enclosure.
[0017] The device described herein offers continuous and critical
radiation protection by partially or fully automating the radiation
protection process as well as providing optimal patient and HCW
ergonomics.
[0018] The primary problem with prior attempts to provide x-ray
scatter radiation shielding is that the shield must conform to the
patient's body contour and also be able to conform to the x-ray
imaging device. Patients come in a wide variety of shapes. X-ray
units are bulky and the physician often needs to image the patient
at widely varied angles relative to the patient's long axis. For
example, cardiac imaging requires the x-ray camera to be positioned
in all four quadrants (over the left and right shoulder and over
the left and right rib cage). The physician usually inserts a
catheter into a blood vessel at a specific location such as the
femoral artery, radial artery or jugular vein. The physician often
needs to stand next to that body part during the procedure. As a
result, an ideal shielding system would be able to conform to both
the patient shape and the position of the x-ray camera.
[0019] A number of shields have been developed to absorb scatter
x-ray. The most commonly employed is an apron, vest or skirt with
integrated x-ray absorbing material that is worn by the user. X-ray
absorbing gloves, glasses, and head caps have been worn to prevent
x-ray exposure of specific body areas. These devices are
cumbersome, heavy, and have been associated with orthopedic
injuries. X-ray absorbing pads have also been developed (U.S. Pat.
No. 6,674,087, U.S. Pat. No. 7,677,214). Problems keeping the pads
clean from patient to patient have led to their use in a disposable
form. This adds to medical cost and toxic waste. Finally, fixed,
durable x-ray shielding has been used extensively. These devices
primarily include leaded glass or acrylic in planar sheets hung
from the ceiling, attached to the rails of an x-ray table, or
placed into a free-standing structure (such as a wheeled structure
or apparatus hung from the ceiling). Cocoons (in which the
physician resides while operating) that absorb x-ray and large
x-ray absorbing barriers have also been described (US20020109107,
U.S. Pat. No. 7,091,508). These devices have shown to be too
cumbersome to be of practical use. A number of other fixed or
mobile x-ray shields have also been described. They provide partial
x-ray protection for the physician and staff.
[0020] One challenge to x-ray visualization in the cath lab is
ensuring that the area of treatment in the patient is not blocked
by radiopaque materials that prevent adequate x-ray penetration for
imaging. Typically, any radiopaque clip, instrument or wiring that
is near the patient will appear on x-ray and potentially prevent
visualization of critical anatomy. In particular, cables such as
ECG leads that may drape across the patient can cause imaging
difficulty. Many medical procedures require imaging of body parts
and simultaneous monitoring of physiologic functions, such as an
electrocardiogram, blood oximetry, respiratory rate, and blood
pressure. Many conductors of electricity, such as copper and gold,
are visible under x-ray and interfere with medical imaging. Even
aluminum, which is less visible under medical x-ray, can be seen
when the wire diameter is sufficiently large or when multiple wires
are stacked together, such as when conductors are circled by a
shielding material. These problems interfere with the monitoring of
patients undergoing x-ray examinations.
[0021] While there are concerns that clips and wiring may interfere
with visualization of patient anatomy, there is a need for
connections to the patient in a manner that provide critical
diagnostic information. Pulse oximetry, electrocardiographic traces
and blood pressure readings are all examples of data that may be
vitally important during a medical procedure. Currently, the
methods used to gather this information are not streamlined or
synchronized in a manner that is conducive to simple and easy use
in the interventional cath lab or other medical settings. Solesbee
(U.S. Pat. No. 6,721,977) described the use of wires in a patient
mattress to allow integration of patient monitoring cables. Wilson
and Kim (U.S. Pat. No. 8,491,473) describe a conduit system within
a patient mattress, where the conduit carries wires for monitoring
and patient treatment. These are useful additions to the patient
mattress, but the conductors and conduits are visible on x-ray
imaging when the x-ray camera is turned in some directions (such as
when the x-ray tube is under the patient's right shoulder aimed at
an x-ray detector that is over the patient's left lateral chest).
Wiring that is conductive but nearly invisible under x-ray would
improve the inventions of Solesbee et al (U.S. Pat. No. 6,721,977)
and Wilson et al (U.S. Pat. No. 8,491,473).
[0022] Others have described mattresses of composite construction,
including possible components such as flexible inner members with a
range of stiffness and an outer containment jacket or cover.
However, no present invention envisions a mattress of composite
construction that utilizes the materials of the construction to
provide for a rigid frame, patient comfort and a suite of features
that may provide solutions to previously unresolved issues related
to imaging, radiation exposure, cleaning and modular attachment of
arm boards or other devices and monitors.
OBJECTS AND SUMMARY OF THE INVENTION
[0023] Aspects of the invention described herein generally include:
[0024] 1. A mattress on which a patient lies, where the mattress is
contained within an outer, more rigid shell [0025] 2. Rails
attached to the mattress or mattress shell are used to attach
medical devices and shielding, where the rails may contain a power
supply, medical gasses, and conductors for data and computer
communication [0026] 3. A flexible x-ray shielding system that
conforms partially to the patient and x-ray system independently
[0027] 4. A wiring system composed of flat conductors that are
minimally visible on x-ray [0028] 5. A blood pressure cuff that can
be applied around the arm or leg like a clamshell [0029] 6. One or
more work surfaces that attach to the mattress rail and provide
attachments for clips and other devices to stabilize catheters in
the sterile field, an inductive power supply to the sterile field,
and radiation shielding [0030] 7. One or more heating elements in
the mattress with one or more surface temperature feedback sensors
that can be used to warm patients in selective body locations or to
sterilize the mattress with heat [0031] 8. An attachment for
cardiopulmonary resuscitation that attaches to the mattress rails
and derives power or data control from the rails or mattress.
[0032] 9. An intravenous infusion pump that receives power from the
mattress rails or data control from the mattress or mattress rails.
[0033] 10. A capacitive ECG sensor that is imbedded into the
mattress cover or located below the cover and associated electronic
signal processing to provide an ECG signal from the patient lying
on the mattress. [0034] 11. A device to hold the patient's head
that provides radiation shielding, stabilization of head position,
and a wrap around the neck that allows for rapid circumferential
cooling of the neck to provide brain hypothermia.
[0035] This invention describes a medical procedure mat designed to
provide integrated patient monitoring and comfort by having a
mattress and perimeter shell. The shell is composed of a material
more rigid than the foam mattress supporting the patient, such as
closed cell foam, fiber glass, carbon fiber, or other rigid
material that has minimal x-ray absorption, and an inner insert
with open cell or more elastic material to provide comfort. The
surface upon which the patient will reside is covered with either
flexible closed-cell foam or another appropriate textile that is
durable and easily cleaned after use. Medical monitoring and
connections to the monitoring devices may reside in between the
rigid and flexible layers.
[0036] The invention is an object on which a human can lay or sit,
where the object contains sensors to monitor physiologic functions.
In addition, the object may contain therapeutic devices to provide
treatment. In addition, the device has a variety of compartments to
house medical equipment and a perimeter rail attached directly to
the mattress to provide additional monitoring and therapeutic
devices, and a system for distributing electrical power, medical
gasses, computer data transmission, and radio receivers and
transmitters.
[0037] In one embodiment, the object is composed of carbon fiber.
The carbon fiber supplies sufficient rigidity to support the
remainder of the object, including the included devices and the
patient. The carbon fiber structure has cavities or drawers for
storage of devices and wiring (including electrical and optical
cables, with optional electromagnetic shielding). In addition, the
closed carbon fiber may also have rigid members within or covering
the foam to provide additional structural integrity.
[0038] In one embodiment, the main cavity of the closed cell foam 1
is filled with a softer foam 2 for patient comfort. In one
embodiment, one or more top layers of foam are provided to further
enhance comfort or to provide specialized functions, such as
electrical conductivity, magnetic properties, radiation blocking
agents, antibacterial, antifungal or antiviral properties, or
photon transmission.
[0039] In one series of embodiments, the procedure mat is designed
to integrate with commonly used procedure tables that have been
installed in the hospital or clinic. In this way, the mat replaces
the simple mattress that sits upon the table with a device that
provides for patient comfort as well as patient monitoring and
cable management.
[0040] In one such embodiment, the procedure mat is a relatively
rectangular shell structure constructed of relatively rigid
closed-cell foam with an open top surface. In another embodiment,
the shell is composed of carbon fiber. In yet another embodiment,
the shell is composed of aluminum. This shell contains a cavity to
house an inner mattress component while acting to provide
structural rigidity to the composite device, allowing for routing
of cables or wiring throughout the mat and locations to which other
structural members such as rails or monitors may be mounted. The
inner mattress component is a compliant material which provides for
patient comfort. The upper surface of the mat will be covered by a
flexible, non-permeable material that will provide for patient
comfort as well as furnish a non-porous surface that is impermeable
to fluids, resists staining and is easily cleanable.
[0041] This profile of this structure may also be adapted to better
match patient anatomy and provide closer access to the patient from
the caregiver or for diagnostic, therapeutic or imaging equipment.
In these configurations, the head region of the mat is narrowed,
with the mat increasing in width at the shoulder level and possibly
again at the hip level on a supine patient. This type of mat
configuration and others may be dimensionally specified to match
geometries with procedure tables produced for interventional
cardiology, radiology, surgery or other use. In another embodiment,
the flexible portion of the mat has protrusion or indentations that
facilitate the positioning of the patient on the mat, such as a
protrusion at the superior shoulder level to guide optimal
positioning of the patient in the long axis of the mat. Similarly,
indentations or protrusions for the trunk head, or legs help
position these body areas in the left-right axis of the mat.
[0042] In yet another embodiment of the procedure mat, the mat
contains other features to improve functionality for specific uses.
In the region within the mat on which the patient's torso rests,
the mat may contain a more rigid support structure that supports
the chest of the patient The purpose of this more rigid structure
to improve the effectiveness of chest compressions if they are
required for cardiac resuscitation.
[0043] Another feature of the outer more rigid structure of foam or
carbon fiber is the ability to create outer ridges that prevent
patients from falling off of the mattress. In one embodiment, the
outer ridge can by folded to the outer side of the mattress to
allow easier transfer of the patient of the mattress. Moreover, the
hinged segment, once folded over, provides an extended surface for
transfer.
[0044] The anchoring of components to the mat is deemed beneficial
in particular when considering the range of procedures that may be
performed on a patient residing upon the mat. In the case of
interventional cardiology, arm boards are often desired to provide
a location upon which the patient may rest their arms. Current
technology uses a rigid polymeric sheet that is anchored by placing
it under the torso of the patient, an unwieldy and uncomfortable
environment. The anchoring component of the mat allows for arm
boards 4 made of foam or other material to be designed to be
integrated with the anchoring component so that they may be
attached or detached as desired. This provides simple, modular and
comfortable use of arm boards when necessary for a procedure.
[0045] The resuscitation aspect of the embedded reinforcing
structure provides a significant benefit when compared to the
current state of the art. At the present time, if a patient suffers
from cardiac arrest and requires resuscitation, the physician will
initiate chest compressions while the patient is lying on a
standard mattress. The typical mattress has significant
compressibility, meaning that for each chest compression applied by
the physician, a substantial amount of the energy goes into
compressing the mattress rather than compressing the rib cage and
ultimately the heart. The result is less-effective compressions,
causing a significantly higher level of fatigue to the physician
and reduced cardiac output. By adding a rigid component in place of
a portion of the mattress under the chest of the patient, the
compressibility of the mat is reduced. Therefore, the result is
more effective chest compressions which result in lower physician
fatigue and better clinical results.
[0046] In addition to the modular arm boards that may be added to
the edges of the mat, additional components may be added to the mat
itself or modularly added to arm boards that are attached to the
mat. In one particular embodiment, flexible radiation shields may
be reversibly affixed to the arm boards on a mat used in
interventional cardiology or radiology procedures in such a way
that they may extend vertically, horizontally or in a curved manner
around the patient. These radiation shields are designed such that
they prevent x-ray radiation that reflects or backscatters from the
patient from reaching the physician or catheter lab staff. Other
modular radiation shields may be placed at or near the waist of the
patient and/or near the neck of the patient to prevent backscatter
radiation from exiting the imaging field. Each of these shields are
designed such that they will flex out of the way when contacted by
the image intensifier of the c-arm or x-ray imaging unit as it
rotates around the patient.
[0047] These modular shields may be designed such that they act
independently of one another so that movement or use of one
component does not affect the other components. Alternatively, they
may be designed to mate with one another such that they are
attached to one another during use with clips, snaps or magnets, or
their geometric design may be such that the components nest within
one another in their static position. In one embodiment, the edges
of the components are magnetically attracted to one another so that
they provide continuous radiation protection around the patient
through direct contact between the components, but when the image
intensifier pushes on the component the magnetic attraction between
components is broken and the impacted radiation shield is free to
bend and flex out of the way.
[0048] In another embodiment, the winged radiation shield attached
to the mattress can bend on a hinge, for example a hinge with a
spring that biases the hinge to a position such that the radiation
shield is in an upright position. When an x-ray camera needs to be
positioned such that the radiation shield would prevent the user
from obtaining the desired radiographic projection, the shield can
be reversibly moved aside by the movement of the camera by the
shield pivoting on the hinge. If a view is desired that is more
lateral than can be provided by the wing with the spring-loaded
hinge, a release mechanism can be actuated that deactivates the
spring and allows the hinge to rotate completely downward, moving
the wing out of the field of view.
[0049] In yet another embodiment, the neck and waist components of
the radiation shield are specifically adapted to ensure that
vascular access can be gained for an interventional procedure.
There are notches or cutouts provided in the shield so that the
femoral artery and femoral vein may be reached in the leg, and the
carotid artery and jugular vein may be reached in the neck.
Additionally, the radiopacity of the shield components may be
reduced in key regions so that areas that may require visualization
such as the distal aorta and the iliac arteries can be seen through
the shield.
[0050] In yet another embodiment, the waist component of the device
consists of a "Flag" with elements to conform to patients' body
habitus and other elements to flexibly and reversibly deform to
accommodate other equipment in the environment of the operating
room.
[0051] The flag consists of an element that attaches the Flag to
the patient's mattress, the table the patient lies on, a free
standing device or to a wall or ceiling mount. The attachment
mechanism has one or more rigid arms connected at an angle, such
that an arm(s) are horizontal and extend from the Attachment
mechanism. Below one of the arms is a radiation absorbing material
configured in such a way as to conform to the patient's body. Above
the same or another arm is a radio-absorbing material that can be
reversibly displaced. For example, an x-ray camera can be
positioned such that it pushes the upper part of the shield away to
allow the camera to be positioned for a particular x-ray view.
[0052] The upper functional unit has a degree of internal
flexibility/elasticity and has a horizontal articulation with a
lower functional unit and a vertical articulation with a lateral
functional unit. This allows the upper unit to freely move on a
horizontal axis as well as have some elastic stretch when the
equipment in the room such as an image intensifier pushes it to
enable optimal imaging conditions. This allows the lower functional
unit to remain in place on the patient continuing to block
radiation scatter from the patient's body while the upper unit
bends away and conforms to the image intensifier. In addition, the
Flag can have vertical supports throughout. The supports contain a
hinge or spring apparatus to allow the Flag to bend in the vertical
plane. This allows the Flag to conform to other radiation absorbing
material, allowing the Flag continues to form a shell around the
patient to continue blocking the radiation scatter. Because the
Flag has elastic properties, when the image intensifier moves away
from an interfering position, the Flag returns to its initial
position, preventing gaps in the shielding where radiation may be
emitted towards the HCW.
[0053] In one embodiment, the Flag has asymmetric curves that
contour to a patient body habitus in the lower functional unit to
maximize radiation protection to the HCW.
[0054] This novel invention contrasts with current devices, which
are pushed out of the way by the image intensifier or the HCW to
prevent getting in the way of the HCW being able to work with
catheters etc.
[0055] The invention allows the lower portion of the flag to stay
in place without moving away and also adds the ability of the upper
functional unit to continue to offer radiation protection. This
combination minimizes or eliminates the interference to the HCW
work flow and allows them to continue their procedure
uninterrupted.
[0056] The third functional unit in the current embodiment includes
a contoured lateral unit which has a vertical articulation with the
upper and lower units of the flag. The lateral unit curves towards
the patient to block the radiation that currently reaches the HCW
due to the wide gap between the floating ceiling-mounted shield and
a lateral shield sometimes used by HCWs. The vertical articulation
also allows for the flag to conform with the lateral wing described
previously. In addition, there are also cut out areas along the
lower border of the lateral and lower functional units to contour
to the patients forearm and the groin area to allow for maximal
visualization.
[0057] The radioabsorbent barriers on the top or bottom of the Flag
can be composed of multiple overlapping material, such that an
object displacing one piece of material would not displace the
adjacent section. This would improve radiation protection.
[0058] The flag units can be constructed of radioabsorbent fully or
partially transparent material or could have a radioabsorbent clear
window in portions to allow for optimal patient visualization. The
Flag also can hold a patient instruction and or entertainment
window where a screen could be placed.
[0059] In another embodiment, the flexible portion of upper part of
the radiation shield is composed of multiple rigid elements that
are attached to the shield with at a hinge. The elements absorb
x-ray and can flex at the hinge point passively as the x-ray
detector pushes them. The hinge can be a simple spring hinge that
rotates in one plane or a ball hinge that rotates in two planes. It
is recognized that many types of hinges could provide a rotating
mechanism. An advantage of multiple hinged shields is that only a
portion of the shield will be displaced, improving radiation
protection of the operator and also reducing the force needed to
move the portion of the shield that obstructs the x-ray detector.
An additional benefit is the transparent shielding material, which
is inherently inflexible, can be incorporated into the shield. This
has the advantage of allowing the physician to see the patient
through the flexible shield.
[0060] In another embodiment, the multiple rigid elements are
composed of a mixture of flexible and in flexible material. For
example, leaded glass can be combined with a flexible polymer
material, such that a portion of the individual element is flexible
and a portion is rigid.
[0061] In another embodiment, the multiple element shield can be
attached to the workbench, such that the element rotate from the
workbench, which serves as a supporting member.
[0062] The Flag is anchored to the mattress or patient table, to
another free standing mechanism or to a wall or ceiling with
features that allow for rapid stowage. The Flag has freedom to
rotate on 3-axes and also has spring loading mechanisms built in
such that it assists the HCW in moving the flag with minimal use of
force and allows for the flag to return back to a neutral position
or to another position between neutral and extreme flexion or
extension to contours to the patient and the equipment in the room
as closely as possible.
[0063] Invasive angiography and other medical procedures and
operations are often performed on patient lying on support
structures known as operating tables. In some patients, the upper
extremities are instrumented, particularly the radial artery in the
wrist. The arm usually rests on an arm board that is attached to
the operating table. The arm is often abducted to allow better
access to the wrist or antecubital fossa. The arm board holding the
abducted arm often pivots away from the operating table to support
the abducted arm.
[0064] In procedures where catheters or other medical instruments
extend from the arm in a caudal direction there is no supporting
surface on which the catheter or instruments can lie. As a result,
the physician either holds the catheter manually or drapes it over
the operating table by curving the catheter or instrument. This
leads to catheters or instruments falling off the table or
diminishes the physician's ability to manipulate the catheter or
device. The problem is particularly present in patients undergoing
radial artery catheterization, where multiple catheters and
guidewires can extend out of the radial artery for over a meter in
length.
[0065] There are support surfaces that attach to operating tables
or are positioned partially between the mattress and the operating
table. Although helpful, the attachment point is below of the
surface of the mattress and the tables must be removed during
patient transport. In addition, these tables are simple surfaces,
some with x-ray absorbing capacity but no ancillary capabilities to
manage the catheters and wires emanating from the patient or
attachment of devices to supply inductive power to the sterile
field.
[0066] The invention described here is a generally rectangular
table that can be attached to the procedure mattress, usually by
attaching to a rail on the mattress. One feature of this board is
the ability to attach clips to hold catheters or wire. Another
feature is the presence of an induction coil to transfer power to
devices in the sterile field. Yet another feature is a quick
release mechanism. Another feature is a mechanism to fold or rotate
the table against the operating table to allow for the transport of
patients on and off of the operating table and mattress.
[0067] In another embodiment, the outer ridge of the outer shell is
hinged such that it can be folded over to the outside of the
mattress, creating a flat structure that extends from the mattress
outward. This flat surface can then serve as a table for the
physician to use during the procedure.
[0068] The ability to clip or hold catheters and guidewires in
place would improve procedure safety, free the surgeon's hands for
other tasks, and facilitate faster catheter exchanges over the
guidewires. The problem with clips is that the operating table is
typically covered with a sterile drape. The drape is loose fitting
and moves. To solve this problem, two methods are described for
attachment of devices to hold wires or catheters. In one
embodiment, magnets (such as NdFeB) are placed at or within the
surface, at certain spots on the board. Wire or catheter holders on
the top of the sterile drape mate with the magnets. The holders
have either oppositely polarized magnets or a magnetically
attractive material (such as steel or iron). This allows them to
hold position through the drape material. In addition, the use of
two oppositely polarized magnets on one side prevents movement
further. In another embodiment, the clip holder has the magnet and
the board has areas of magnetically attractive material, (either
discrete areas, tracks, or the entire board). Alternatively, the
wire holder could be a simple magnet or magnetic material that is
designed to mate with the magnets embedded within the surface of
the patient mattress. The intravascular device such as a wire or
catheter is placed on the drape atop the magnet, and a magnet or
magnetic material covered in a soft polymer such as silicone is
placed on top of the wire or catheter. The magnetic attraction
between the two components will apply pressure on the wire or
catheter, and the combination of the pressure and the coefficient
of friction of the polymeric material will prevent movement of the
interventional device. The soft polymeric material will also
prevent damage to the sometimes fragile interventional device.
[0069] Another embodiment of a connector from the sterile field to
the table is a clip. The clip is typically attached to the table.
The opening is wide enough to allow the drape to lie within the
clip. A wire or catheter holder then sits on top of the drape. It
has a configuration that mates with the underlying holder,
reversibly locking the upper holder to attach to the table.
[0070] In another embodiment, an adhesive pad attached to the
underside of the drape or the surface of the table holds the drape
to the table. The wire or catheter holder is attached adhesively to
the attached drape.
[0071] Another embodiment of a clip mechanism that provides for
simple attachment and release may be constructed of a highly
compliant material such as silicone rubber or foam with a magnetic
component in the base to affix to the table surface as described
above. This compliant component has a notch or space in which the
interventional device to be held will reside. Manual compression of
the edges of the device compress the notch and grip the device. The
deformation of the device by the act of compression causes clips
mounted on either one or both sides of the non-compressed axis to
extend beyond one end of the device and lock the device in the
closed configuration. The ends of the clips on the non-attached
side of the device extend beyond the compressible component of the
device. Compression of these clip ends lever the locking end of the
clips and release the compression. In this way, the locking can be
effected using two fingers in compression on the complaint material
and unlocking can be effected by using two fingers to compress the
clip ends. The combination of the use of a simple attachment and
release mechanism and highly compliant materials provide for a
highly effective and easy to use component that is protective of
the potentially fragile devices used in interventional
procedures.
[0072] It is recognized that a combination of the attachment
mechanisms could be used together.
[0073] Delivering electrical power to devices in a sterile field
has always been difficult. Typically, the power is provided by
sterile batteries or by a wire that is wrapped in a sterile drape.
In this aspect of the invention, an induction coil is located
within the operating table or side table. The induction coil sits
in the non-sterile part of the field and is attached at one end to
a power source and at the other end to the coil. Typically, the
coil is mounted on the table in plane and at or near the surface of
the table. A sterile receiving coil is placed over the coil, above
the sterile drape. There is a mechanism for fixing the position of
the receiving coil relative to underlying coil. These mechanisms
include: adhesion of the receiving coil to the drape and drape
adhesion to the table, magnetic connectors as described above, and
clip connectors as described above.
[0074] In another embodiment, the inductive power source is used to
control a medical device through changes in the power delivered.
For example, the power to a motor used to drive an ultrasound probe
to spin within a catheter can be adjusted to control the rate of
spin and the position of the ultra sound generating element within
the log axis of the catheter in the patient.
[0075] A table described above must be able to be moved out of the
way in order for a patient to get onto the operating table. The
table described herein can be attached through a quick-connect. In
addition, it is anticipated that one could fold the table against
the operating room table side.
[0076] Another type of work surface that may be used in conjunction
with the mattress is a workbench that resides over the patient on
the table, particularly over the lower legs of the patient. This
device provides radiation protection, improves workflow, provides
equipment storage, can easily be draped with a sterile bag,
provides access for vascular catheter access, and can easily and
quickly be removed from the operating field. In addition, one
embodiment facilitates application of pressure to the body to
reduce bleeding.
[0077] This device component consists of a horizontal tray that
curves downward on the end facing the operator. The tray is
positioned across the patient's body. The tray is composed of a
radio-opaque material that blocks x-radiation. The radio-opaque
material absorbs x-ray photons emitting from the patient while the
patient is undergoing an x-ray imaging procedure. The curve of the
tray blocks radiation emitting from the side or legs of the
patient. The operator radiation exposure is therefore reduced.
[0078] The tray is connected to an attachment apparatus to then
connect the device to a supporting structure (such as a bed or
x-ray table). The attachment apparatus is fastened to the mattress
or table that the patient lies on or a side-rail. A mechanism in
the attachment apparatus allows the tray to rotate around the axis
of the attachment apparatus, to flip up toward the attachment
apparatus, and to tilt with one edge of the tray closer or farther
away from the patient. The attachment mechanism itself can travel
in a vertical up and down motion to move the tray above the patient
and to lower the tray to the patient's body. This allows the tray
to be positioned across and just above the patient easily, which
allows the device to accommodate patients of different body shapes.
It also allows for the tray to be removed up and out of the way
quickly in case of emergency.
[0079] In another embodiment, the tray is a laminar construct with
one or more layers of radio-opaque material and one or more layers
of material with minimal x-ray absorption. In another embodiment
the tray is composed a clear x-ray absorbing material such as a
clear plastic polymer with a high content of an x-ray absorbing
material (such as boron, beryllium, barium). In another embodiment,
the tray has attachments that do not absorb x-rays, such as a piece
that connects to the attachment apparatus and the tray. In another
embodiment, the tray has a forward edge that curves upward to more
comfortably rest against the patients belly to further block
radiation from the body.
[0080] In another embodiment, the tray is attached to a free
standing device.
[0081] In another embodiment, the dimensions of the tray are
adjustable to fit different patient sizes. Since the tray is
connected to an attachment device, the distance between the
attachment device and an anatomical landmark (such as the femoral
artery) needs to be adjustable so that the functional aspects (such
as the cutouts for access to the femoral artery) can be located
over the appropriate body location. Additionally, the tray
functional aspects might need to be placed over two or more body
areas. The tray can also have multiple sliding or rotating
adjustable surfaces to fit the body dimensions of the patient. On
mechanism is one or more sliding elements. Another mechanism in a
rotation of two elements on a swivel hinge.
[0082] The tray has cut outs to facilitate access to parts of the
body, such as the femoral artery and vein, while minimizing x-ray
transmission. In addition, radio-opaque flaps or barriers attached
to the access sites can be opened and closed to allow access when
the x-ray is off. In addition, ridges near the access site block
x-ray photons that are directed at the operator's position.
[0083] The tray has attachment devices to hold sterile surgical
instruments, imaging devices, or supplies. These attachments allow
the operator to have free hands for other tasks, such a puncturing
an artery while the attachment holds an ultrasound probe to
visualize the artery through the skin. In one embodiment, the
attachments are connected to the tray underneath the sterile
barrier or surgical drape and in another embodiment, the
instruments are attached over a sterile barrier or surgical
drape.
[0084] The tray also has indentations that provide storage areas
for surgical devices and supplies, such as needles, guidewire
attachments, gauze, suture, and sterile fluids. In addition, the
tray has spring clips and other attachment devices to hold
catheters and wires emanating from the body. This stabilizes the
positions of the catheters or wires and frees up the operators
hands.
[0085] A light may be attached to the tray illuminates the surgical
area. The light may be controlled by a switch on the tray or by a
remote device (such as a wireless device). The light can provide
general lighting to the procedure area or a focused light on a
particular area of interest. The lights are often dimmed in the
x-ray imaging rooms and white light can interfere with the
operators viewing of procedure monitors. In one embodiment, lights
of different colors are used to provide lighting that optimizes the
viewing of x-ray and vital sign monitors.
[0086] In another embodiment, advantage is taken of the position of
the tray over the body. During some types of surgical procedures,
pressure needs to be applied to the body, for example, to stop
bleeding or compress a hematoma. This can be challenging when the
bleeding occurs next to the surgical site. The operator needs to be
manipulating catheters or surgical devices and cannot press on the
body at the same time. An assistant's hands in the field obstruct
the operator's hands. A balloon or active device under the tray can
be inflated or activated to produce pressure on the body. When a
balloon is employed, the balloon can be inflated by an electric
pump, a manual pump operated by an assistant outside the sterile
field, a manual pump pumped through the drape by the operator.
Alternatively, a simple broad foot can be extended mechanically
(such as a ratchet mechanism) down from the lower surface or side
of the tray and mechanically locked into place.
[0087] Other balloon compression or mechanical compression devices
exist. A balloon device is employed in a band that surrounds the
patient. Mechanical C-clamps are used with one portion of the
C-clamp under the patient and a compression foot is over the body.
These devices are difficult to employ during a sterile procedure
and require contact with the posterior and anterior aspects of the
patient.
[0088] A key feature of this device is that it is used during
sterile procedures. The asymmetrical connection to the attachment
device permits easy draping with a sterile pouch or cover that
covers both the upper side of the tray (where the gloved operator
touches) and the lower side of the tray that meets the patient's
sterilely prepped skin or the sterile drape covering the patient.
In an alternative embodiment, the entire tray is delivered sterile
and attached to the attachment mechanism by a gloved operator. In
yet another embodiment, the attachment mechanism and the tray are
sterile and are attached to the mattress, rail, table or
freestanding device by a globed operator.
[0089] Another embodiment includes a dedicated mount that attaches
to the bed or tray, to which an IV pole or other device (infusion
pump, etc) could be mounted. The device has flexibility of position
so that it can be pivoted to multiple positions or otherwise moved
out of the way if necessary.
[0090] Devices are described that are usable to attach a catheter,
wire, or other medical device to an operating table. The device has
an attachment mechanism whereby the holder can be affixed to a
drape or operating table (with or without a sterile drape), as
described above. The holder is type of clip device, where the inner
surface of the clip is covered with an elastomeric material or a
material treated to facilitate attachment to a medical device by a
friction fit. On example of an elastomer is a foam material.
Another is silicone. Another is a gel material. An example of a
friction enhancing material is silicone, certain rubbers, and
materials where the surface is treated. Surface treatments include
grit, ribs and grooves.
[0091] Measurement of blood pressure in a clinical environment
typically is done using a cuff that surrounds the arm and a
pressure gauge. The cuff contains an air bladder that can be
reversibly pressurized using a pump. The air bladder is connected
to a pressure gauge. The cuff containing the air bladder is
typically a strip a long rectangular shape that can be wrapped
around a arm or leg and fastened with a variety of fasteners (such
as Velcro, hooks, or buckles) to approximate the air bladder to the
size of the arm. The air bladder is typically pressurized to a
level that arterial blood flow to the arm is obstructed by the
pressure of the bladder encircling the arm. As the pressure is let
out of the bladder, blood will flow into the arm intermittently
when the encircling pressure falls below the systolic blood
pressure. Flow will become continuous when the pressure falls below
the diastolic blood pressure. The occurrence of intermittent and
continuous flow can be determined using several methods, most often
by listening for Karotkoff sounds using a stethoscope or using the
occillometric method.
[0092] One problem with the measurement of blood pressure using a
cuff is that the cuff must be placed circumferentially around the
arm. This requires the person applying the cuff to use two hands to
apply the cuff to the arm. In addition, creating a cuff that
automatically attaches to the arm has been difficult.
[0093] Provided is a clamshell-like device containing an air
bladder that reversibly attaches to the arm or leg. The advantage
of the device is that a blood pressure cuff can be attached easily
using one hand, without the need to circumferentially wrap the
bladder around the arm or leg. In addition, the clamshell device
can be attached to a surface and provide an automatic attachment by
the motion of the arm into the open clamshell. The force of the arm
into the clamshell activates the closure of the clamshell by
mechanical means or by triggering a switch that secondarily cause
closure (such as using a motorized closure).
[0094] Factors that affect pressure measurement by the
occillometric method are the housing around the air bladder, the
completeness of the encircling air bladder, and the elasticity of
the encircling air bladder. In testing, it was found that a rigid
outer constraining device causes more discomfort and changes the
oscillatory changes in pressure relative to the blood pressure. In
one embodiment of this invention, the outer housing of the air
bladder is a rigid hemi-cylinder and interposed between the rigid
outer housing and the air bladder is an elastic material that is
compressed as the air bladder is pressurized. This allows the
airbladder to pulsate as the pressure is reduced to less than
systolic, but higher than diastolic pressure during blood pressure
measurement. The material could be a foam or could simply be an air
void where the bladder is attached to the rigid structure along its
edges.
[0095] The two edges of the encircling housing may be attached
securely in order to apply circumferential pressure to the limb.
One method of fixing the clamshell into a closed position around
the arm is to employ a spring mechanism, biasing the clamshell in
the closed position. It was found that this type of configuration
had two drawbacks. First, the spring constant required for
effective closure was very high and posed problems for a user to
open the clamshell with one hand. Second, the spring altered the
oscillation of air bladder pressure relative to the actual blood
pressure, making measurement of blood pressure less accurate.
Closure of the clamshell at the parting line was much more
effective. This can be accomplished using a number of methods, such
as a magnetic attachment, a hook or clasp, a releasable ratchet
mechanism, or a pin and receptacle releasable lock. In one
embodiment, the attachment and release is performed with one
hand.
[0096] The housing for the air bladder may be composed of a rigid
shell, such as a metal or polymer. This provides the easiest
manipulation of the device. Alternatively, the outer housing can be
made from a flexible material (such as cloth, polymer, or foam)
with a support skeleton compose of a more rigid material, such as
steel, nitinol, or rigid polymer. In another embodiment, a rigid
foam material can be used without the need for internal support.
The advantage of this embodiment is that the inflation of the
bladder causes less discomfort.
[0097] In one embodiment, the clamshell device is attached to a
medical procedure mattress, arm board, chair or other surface. In
one aspect of the embodiment, the air tubing to connect the air
bladder with the pressure gauge is integral to the surface on which
the cuff is mounted, that is, the tubing is attached to the
mattress arm board or chair, or in a channel within the supporting
devices.
[0098] In another embodiment, tubes emanating from the airbladder
attach to the supporting structure by means of a valved or
non-valved plug-in connection.
[0099] In another embodiment, the parting line is not closed for
the measurement of blood pressure (FIG. 4d). The clamshell is
bias-closed by a spring type mechanism (including a spring or
compressible air reservoir). A sensor measures the angle at the
hinge point of the clamshell, which can be converted to a
cross-sectional area described by the inner diameter of the
clamshell. The pulsation of blood in the limb will cause the angle
to fluctuate. In another embodiment, a detector can be mounted on
the parting line to detect fluctuation in clamshell dimensions. A
Hall Effect sensor is an example. Another example is a laser sensor
to detect distance.
[0100] In another embodiment, the distance between two levers
attached to the clamshell measured by any of a variety of means
(such as a laser) measured over time describes the change in
clamshell cross-sectional area. An air bladder in the clamshell is
inflated until the inner cross sectional area no longer fluctuates
because the inflow of blood has stopped. As the air bladder
increases in size, the clamshell is expanded open against the
spring type device near the hinge point, increasing the nearly
circumferential pressure around the limb until blood flow into the
limb ceases. The pressure in the air bladder is then reduced
slowly. When the fluctuation in clamshell dimensions appears, the
pressure in the air bladder is assumed to be the systolic blood
pressure. As the pressure is reduced further, there will be a
reduction in pulsation as the blood flow becomes continuous when
the pressure in the bladder is less than the diastolic pressure.
This will be the diastolic blood pressure, which can be displayed.
In another embodiment, there is no air bladder. Instead, the spring
pressure is increased to increase the closing pressure of the
clamshell. The spring pressure can be increased by a number of
mechanisms. For example, the spring can be turned manually or using
a motor to increase spring tension. An air bladder can be inflated
under or over the spring. Electromagnetic force can be applied by
energizing a magnet or bringing it into opposition with an
oppositely polarized magnet. Alternatively, a constraining cable
can be placed on the spring and the length of the cable (or
constraining device) can be increased to "unleash" the closing
force of the spring.
[0101] Patients undergoing medical transport or procedures often
lie on a mattress. Described above is a mattress with cabling where
medical wires or other sensor conduits are routed through the
patient mattress. The specific type of monitoring equipment needed
for individual patients varies from person to person. In addition,
the site of attachment may vary from person to person. For example,
the blood pressure may be taken from either arm or leg, depending
on the patient's injury or anatomy. Similarly, a pulse oximetry may
be attached to the fingers, toes, ears or other body parts.
Electrocardiographic leads may be attached from 2 to over 12
locations.
[0102] Herein described is a medical device consisting of a support
structure that patients can lie, sit or stand on, where there are
multiple attachments for sensor leads, such as electrocardiogram
leads, pulse oximeter leads, ultrasound transducer wiring, or blood
pressure cuff air tubing channels. In this invention, the leads can
be reversibly attached from one or more of two or more ports, such
that the unattached ports will be automatically inactive by virtue
of the receiving port not having a sensor input attachment.
[0103] In the case of a blood pressure measurement system, at least
two ports in the support structure are available for sensor
attachment. For example, in an occilimetric method blood pressure
cuff the sensor is attached to a pressure gauge by tubing so that
the oscillation in pressure in the cuff can be measured and the
blood pressure can be calculated. Since the blood pressure cuff
could be attached to the right or left arm or leg, it would be
advantageous to have a receiving port at multiple points in the
support structure. An open tubing system with multiple openings
would vent the system to ambient air pressure, eliminating the
signal from the air bladder in the blood pressure cuff. A one end
the tubing is connected to the air sensor. At the other ends, the
tubing branches into multiple outlets. In the first embodiment, a
valved system is provided which is bias-closed, whereby the
insertion of the tube from the blood pressure cuff into the
receptacle opens the valve and connects the cuff bladder to the
sensor. The other ports remain closed because of the bias-closed
valves. In one embodiment, the valves are passive. In another
embodiment, the valves are active, such that opening of one valve
closed the others. The active valve can be driven by electricity
and can communicated with each other wirelessly or by
conductors.
[0104] One potential problem with the tubing system connected
multiple ports is that the air volume of the tubing system
increases. That could make occillometric blood pressure detection
more difficult. The problem is solved by creating an internal
valving system that closes the unused ports from the main tube to
the sensor, unless the receiving port is activated. The connection
between the active receiving port and the remainder of the tubing
system can be accomplished by fixed wire or through a wireless
signal. In another embodiment, all tubing leads directly to an
individual sensor such that the tubing is not interconnected and
where the presence of an oscillating air pressure is sensed and the
sensor is activated.
[0105] In an alternate method, the system may be valved so that all
tubing lines run through a multi-port rotational valve. This valve
may be controlled so that only one pressure cuff may be activated
at a time as the others are shut off. Orientation of this valve may
be manually controlled, or automated by sensors that indicate which
port is in use to select valve orientation.
[0106] Patients undergoing a variety of medical procedures have
electrical current passed through the body for diagnostic or
therapeutic purposes, such as defibrillation of the heart,
electrocautery for surgery, or radiofrequency ablation of tissue
for heart rhythm problems. In most cases, a ground wire is attached
to the patient. The wire is usually mounted to a broad conductive
member and coupled to the patient using a conductive gel. In this
invention, a conductive element is described that is integral to
the procedure mat, such that no additional ground is required. The
patent is coupled to the ground upon lying on sitting on the
device.
[0107] Similarly, electrodes for an electrocardiogram or
electroencephalogram are attached to the skin using a conductive
gel and adhesive agent. Electrodes may be imbedded into a part of a
procedure mattress, chair or head covering, whereby the coupling
occurs without the need for external wires or cables. In an
alternative embodiment, the electrical signal is sensed using
capacitive leads that are integral to the mattress, chair or
head-covering. The leads are connected to a monitoring device or
display by mean of a cable that attaches to the mattress, through
radiofrequency or other forms of wireless transmission, or where
the monitoring device is a part of the mattress.
[0108] In another embodiment, the mattress is foldable. The
foldable mattress will facilitate its use in emergency patient
transport where the rescuer can rapidly transport the mattress to
the patient's location, unfold it, and immediately obtain
physiologic information from the patient and begin to apply
therapy.
[0109] Therapeutic hypothermia has been used to improve the outcome
of patients suffering cardiac arrest or circulatory collapse. By
slowing metabolism and oxygen consumption, organ salvage and
survival is enhanced. One problem is that cooling in the field has
been difficult and cooling in the hospital is often delayed by the
time it takes to apply the cooling equipment. In addition, cooling
of the brain, an essential organ very vulnerable to hypoxia, is
slowed by the skull, which is a heat sink. A head apparatus is
provided with one or more thermistors to sense the cutaneous
temperature of the skull. In addition, the body of the apparatus
contains one or more cavities. The cavity(s) are connected to a
pressurized gas reservoir and an exhaust canal. A pressured valve
can be actuated, whereby the pressurized gas flows into the
cavity(s) and due to the rapid pressure fall, the cavity is rapidly
cooled.
[0110] In one embodiment, the thermistor(s) control the flow of gas
to the cavity(s) individually or together by use of a feedback
loop, whereby the gas is controlled to achieve a set temperature.
This will prevent freezing of the scalp while achieving maximal
cooling. In another embodiment, a thermistor sensing core
temperature would also provide feedback to the regular valve(s) to
reduce flow when a set level of core or brain temperature was
achieved. Core temperature thermistors can be located in the
rectum, blood vessels, ear canal (as a tympanic membrane sensor),
and eyes (as a retinal temperature sensor, esophagus or other
locations.
[0111] In another embodiment, the head covering would also cover
the neck. The neck contains the blood vessels leading to and coming
from the brain. Cooling the neck to aid in brain cooling.
[0112] In another embodiment, the gas flow chambers could be
perfused with a chilled fluid, with similar controls by the
thermistors feedback loop(s).
[0113] A guiderail is described that attaches directly to the
patient mattress rather than its supporting structure. This
guiderail allows for equipment to be fixed to the mobile mattress,
so that when a patient is transferred from table to table, the
mattress may be moved along with the associated equipment without
the need for shifting leads or monitors. In one embodiment, the
rail itself contains electrical power, pressurized gas, and data
communication/control access that can be accessed through
attachments to the rail. This allows the development of ancillary
devices that need not have large batteries or connections to
electricity through a long cable to a point outside the operating
table area. Moreover, creating a common standard for electrical
power (for example 24 volt direct current) would help standardize
medical devices attached to patient care beds. The access to data
communication cables would allow for control of remote devices or
remote control of devices mounted to the rail.
[0114] It is anticipated that this rail attached to the mattress
may have communication with the mattress either through a dedicated
bridge or through the structural attachments to the mattress. The
mattress body can contain electrical power source from a battery,
generator or connection to a power source outside the mattress.
Typically such connections are direct current. Power outlets
located on or near the rail provide a place for the connection for
a variety of medical devices, including a heart pump, resuscitation
devices (such as a device that administers chest compression), a
defibrillator and intravenous infusion pumps. In addition, computer
processing units located in the rail provide the electronic means
of signal processing for physiologic signals, control of medical
devices within or attached to the mattress, and for routing of
electronic or optical signals in the rail or mattress. An advantage
of placing the processing units in the rail is that they are easily
accessible, they can have control surfaces on the rail, and there
can be an associated battery in close proximity in the rail.
[0115] Similarly, the mattress can have a supply of gas within the
mattress body or a supply of gas from a source outside the
mattress. The gas source is within the bed mattress, within or
attached to the rail, or from an outside source that attaches to
the rail by tube or other conduit. The outlet for the gas is also
positioned on the rail. Examples of outlets are simple nipples for
attachment of tubing and quick connect valving. Control of gas flow
occurs either at the outflow site, the inflow site or within the
rail using standard regulators and gas control valves. In one
embodiment, the valving apparatus is controlled by a motor or
magnets and can be actuated wirelessly or using a control cable to
a remote switch within the rail.
[0116] Data communication for the cable attachment in the rail can
be transmitted wirelessly to a control unit not on the rail through
a transmitter in the rail or to the mattress (by wire attached to
the mattress or wirelessly). In another embodiment, power and data
cable could be directly attached to the rail from an outside source
(such as hospital line current with or without a power supply and
isolation source), or hospital computer network, or directly to a
device not mounted onto the rail. Additionally, data transmission
between devices mounted on the rail can be communicated though the
rail communication system.
[0117] It is also anticipated that the rail would be used to help
people or machines transfer patients from one supporting structure
to another. In particular, the rail can be designed such that it
mates with an automated patient transport device, where the
mechanical attachment is matched to the transport device
configuration. In addition, it is anticipated a wireless radio
signal or signals, or other positioning apparatus (such as a
magnetic field), or a radiofrequency identification device (RFID)
located within the rail or attached mattress could facilitate
localization of the mechanical attachment of the transport system
to the mattress and the identification of the specific mattress.
The geometry of the mattress rail may be such that it allows for
quick connection and disconnection of monitors or other
equipment.
[0118] In this invention, a system is described for providing
radiation protection of the personnel in the room of a patient
undergoing a radiographic examination. X-rays directed at and
through patients for medical procedures (such as angiography,
transcatheter therapy, and orthopedic operations) cause backscatter
radiation as the x-rays are deflected by the patient's bones and
tissue. This backscatter radiation is hazardous to personnel in the
environment. Shielding systems have been developed for personnel,
but they have significant drawbacks that have limited their use or
effectiveness. Wearable body shields are heavy and only provide
protection of the covered body parts. The arms, lower legs, head
and neck are often exposed. Skull caps and glasses have limited
effectiveness. Fixed shields mounted to x-ray table or the
procedure room ceilings are bulky and inconvenient. Although the
above described shielding systems such as wearables or fixed
shields are commonly in use, there are only a few systems that
address personnel exposure by efficient anatomic shielding of the
patient's body. These include mats of various size that are
positioned on some parts of the patient's body to reduce scatter
radiation. However, these disposable mats offer limited scatter
protection, frequently fall of the procedure table during table or
patient movements and are impractical to use to cover large areas
of patients anatomy.
[0119] Shielding has been limited somewhat by the need to move the
x-ray tube and detector all around the patient in order for the
physician to examine the body from different angles. Here, an x-ray
shielding system is described that is comprised of an elastic
member with radiation attenuating properties that is mounted to or
on the table or procedure mat the patient is on, such that the
system can easily be pushed aside by the x-ray system.
[0120] In one embodiment, the system in composed of a foam
material, with or without a support layer to allow shape retention
in its natural state but allow distortion with minimal force. The
foam is loaded with radiation attenuating material, such as BaSO4
or boron species.
[0121] In one embodiment, the radiation protection shield is
attached reversibly to the arm board of the patient table or
mattress. In another embodiment it takes the form of a drape over
the patient with a reflecting member that rises in a vertical
manner. The combination of these two embodiments provides a
radiation blocking box around the radiated area, such that the
operator located inferior to the patient's shoulders would receive
less radiation backscatter.
[0122] In another embodiment, a radiation attenuating shield is
integrated into a roller mounted along one side of the mat or
procedure table, rail or another object adjacent to the patient. A
plurality of rollers is envisioned of multiple widths and radiation
protecting characteristics to be used to cover various parts of the
patient's body. In one embodiment, once the patient is positioned
on the mat or procedure table, the radiation shields at the
appropriately desired levels are pulled over the patient's body.
The free edge of this roller sheet is expected to mate with the
opposite side of the mat or table or rail or another object
adjacent to the patient via a securing mechanism that could include
magnetic contacts or hooks or another mechanism that would be easy
to detach intentionally. These rollers could vary in width
depending on the patient's anatomy, such that a wider band might
cover the patient's limbs and abdomen and a narrower band might be
used in other areas such as the neck. The rollers also could be
oriented horizontally or in a vertical or oblique plane such that
they could easily be pulled over the patient and also easily
retracted at the end of the procedure or also during the procedure
if a need arises to visualize areas covered by the roller. In
another embodiment, the radiation shields have areas of
differential radiation attenuation characteristics. Areas of
minimal or low radiation attenuating properties over portion of the
body expected to be required for visualization and adjacent areas
on the shield that have high radiation attenuation properties for
areas of the body that generally do not require visualization
during the procedure. This ability to customize level of
attenuation offers the advantage of achieving higher degree of
scatter radiation protection than currently being used in clinical
practice. In addition, the radiation shields could have openings
located in certain areas to allow the operator access to areas of
the patient's anatomy (such as the femoral artery for percutaneous
vascular procedures). These openings when not required could be
covered by radiation attenuating flaps or another similar mechanism
that would allow easy repositioning to create openings in the
radiation shields. FIGS. 1 and 2 show two versions of the radiation
protection offered by the roller system. In one embodiment of
application of these rollers, a patient is positioned on the mat
with the operator performing a cardiac procedure. The roller is
deployed to cover the patient's abdomen and shows two circular
openings for accessing the femoral artery. The detachable flap over
the right opening is removed and the operator is using this opening
to access the right femoral artery, the left opening overlying the
left femoral artery has a radiation attenuating flap in place that
has not been removed.
[0123] In another embodiment, the operator is at the head end of
the patient performing a procedure which requires access to the
heart from the neck. There are two vertical rollers and a
horizontal roller that cover the right and left chest and upper
abdomen while leaving the access area and area of the heart
requiring visualization exposed. This detachable roller system also
has the advantage of being brought into use outside the sterile
field and applied to offer highly efficient radiation protection by
customizing the areas of the patient's anatomy that would require
to be seen by the operator while eliminating or drastically
reducing the radiation from the patient's anatomy that does not
require to be visualized.
[0124] In another embodiment, there is a hollowed outer member of
roller sheet and a separate radiation attenuating mobile inner
member that could be extended and retracted into the outer member
based on the extent of radiation protection coverage required by
the operator. In one embodiment shown here, the outer member of the
roller is drawn across the patient's abdomen and pelvis, but the
radiation attenuating inner member is only extended over the right
half of the abdomen and pelvis as the operator is accessing the
left sided femoral artery. Once the need for accessing the artery
is completed, the operator can fully extend the inner member to
provide complete radiation attenuation over the abdomen and pelvis
for scatter protection. The inner member can be moved inside the
outer member via various mechanisms. One such embodiment envisions
the inner member to have magnetic properties such that it could
easily be moved forward or backward in the outer member by
application of an external magnetic force. Similarly, the inner
member could also be extended via a motorized fashion. This system
offers the advantage of being able to not break the sterile shield
but at the same time offer customizable radiation protection by
mobilizing the inner member.
[0125] In another embodiment that there could be a spring-loaded
roller sheet that can drop down from the table to the floor and can
be pulled back in as needed to get out of the way of the X-ray
apparatus.
[0126] Cleaning of the radiation shields housed in the rollers is
required to be able to reuse them and to prevent the potential
spread of infectious agents from one patient to another. One
embodiment envisions the application of UV C light housed in the
opening of the rollers such that they would sterilize the radiation
shield as it is rolled in or out of the housing before and or after
each use. The UV C light would simultaneously be directed to the
top and bottom surfaces of the shield while it is rolled into or
out of the housing. Another embodiment envisions use of a
sterilizing liquid in the roller housing.
[0127] Electrocardiogram leads are typically connected to a patient
at specific locations on the body. In the most common ECG, a total
of 10 leads are connected to the body, six of which are at specific
locations on the chest, defined by anatomical landmarks
(specifically, the sternum, ribs and clavicle). Typically, a
disposable conductive patch is adhered reversibly to the patient's
skin in each location desired for lead attachment. A conductive
lead is then attached to the patch by a variety of mechanisms,
including snaps and clasps. Attachment of wire leads to these
location is clumsy and prone to error because the wires can be
attached to the wrong leads. In addition, the labor of attaching
multiple leads adds to cost.
[0128] Previous solutions described include integrating all the
electrodes into one single larger strip or a pad like structure
which is then attached to the patient's body as a single piece with
integrated cable or lead connections to minimize connection errors
and also ease placement. However these systems have not gained much
acceptance as they are large and unwieldy or do not overcome the
problems posed with poor adhesiveness of the patches to the
patient's body or fully account of variations in patient's anatomy
(such as the need for multiple sizes to accommodate for smaller or
larger patients or needing to alter electrode placement to
individualize for patient anatomy).
[0129] Described are methods for attaching leads using a disposable
conductive patch placed on the skin of patients at the location
desired to have an ECG lead and a roller similar to that described
for radiation protection, where the inner surface of the roller
contains a grid of electrically conductive material that is
attached to an electrically conductive pathway to an ECG machine or
to an electronic processing unit. In one embodiment, electrically
conductive patches would adhered to a patient's skin at the points
where an ECG lead is desired (typically, left and right arm, left
and right leg, and six leads on the chest). A conductive gel with a
surrounding adhesive material on the skin side is one type of
conductive patch. The rolled lead array has a first end that is
rolled on a spool and a second end that can be pulled to unroll the
lead array from the spool. The rolled up lead array and enclosure
are typically located to the patient's right or left and affixed to
a fixed object, such as a table rail. The second end is unrolled
across the chest or body. The second end is attached to a fixed
object on the other side of the patient, typically the opposite
table rail. The roller has areas of conductivity (such as a layer
of electrically conductive metal or polymer) that are closely
spaced. Each conductive areas (or cells) are connected in an
isolated track that may be electrically shielded by a second or
third layer of conductive material. The other end of the roller
sheet could be secured to the opposite end of the table or could be
envisioned to have some weight or spring force which allows it rest
on the electrodes while providing the mild compressive force to
secure them. Alternatively there could be a magnetic attachment
mechanism between the electrodes and the cables.
[0130] In one embodiment, an opposite end of the tract is connected
to an electrical processing unit. The electrical processing unit
(EPU) detects if the cell of each lead is substantially in
electrical contact with the body, which occurs when the cell is
placed into contact with a chest patch that is conductive.
Electrical contact of each cell is detected if the cell has a
fluctuating voltage consistent with an ECG signal. Alternatively,
the resistance between the lead and a ground lead connection to the
patient can identify a cell that has electrically active contact.
The electrical processing unit, then determines the identity of
each lead by an algorithm using the cells position on the roller
grid. For example, the right arm chest lead is always the lead most
to the patient right upper side. Lead V1 is the next lead to the
left at mid position on the grid, and so on. The identified leads
are then routed to the appropriate lead connections on the ECG
processing and/or display device.
[0131] It is anticipated that more than one cell could be in
contact with a conductive pad. In that case, the EPU would group
signals from adjacent pads that were in substantial electrical
connectivity with the body. Alternatively, the cell with the
greatest voltage fluctuation, lowest resistance to the ground, or
other connection detection method could be selected as the primary
or only lead cell used in the contiguous area.
[0132] The roller sheet can be spring loaded, similar to a window
shade. The roller sheet is connected to the display system using
standard connections or wirelessly. The system can be modified to
include radiolucent electrodes and radiolucent integrated leads in
the roller sheet for applications that require the use of the EKG
monitoring in procedures requiring the use of x-rays. One example
of radiolucent leads is a radiographically homogeneous grid, such
as an aluminum foil or a fabric or loymer loaded or coated with
conductive material.
[0133] It is also anticipated that the roller lead array could be
combined with standard ECG leads wired to the patient.
[0134] In another embodiment the roller sheet has an integrated
stretch or motion sensor that monitors respiratory rate and quality
of the respiration or change in quality of the respirations based
on the excursion of the patient's chest wall or via an acoustic
sensor detecting air flow through the airways. Operator could be
alerted when the patient might be breathing too slowly, rapidly,
too shallow or having apneic spells.
[0135] Most modern x-ray units have what is referred to as
automatic brightness control, where the x-ray dose (in terms of
photon number and energy) is controlled by a feedback loop from the
detector to the x-ray source, such that the dose is increased to
provide a set level of x-ray intensity at the detector. The
importance of this is that elements in the x-ray field that
homogeneously absorb x-ray may not appear visible to the operators.
Therefore, a radio-opaque electrical conductor that homogeneously
covers the radiographic field would appear to be invisible to the
operator. If that material was interposed between the x-ray source
and the patient, the dose to the patient would be unaffected.
[0136] Conduction of electricity in a conducting agent occurs more
on the periphery of the conductor than in the core (the so-called
"skin effect"), especially when high frequency electrical signals
are conducted. Therefore, maximizing the ratio of the conductor
surface area to the total cross-sectional are could be
advantageous. The invention described here incorporates the
principles of homogeneous conductors within the x-ray radiographic
field that have a very flat profile which results in low
radio-opacity and a very high surface area to cross-sectional area
ratio. Additionally described is a simple manufacturing method to
make a set of shielded conductors with the described attributes.
These conductors are used to conduct signals for medical
monitoring. They are nearly invisible to x-ray imaging and carry
high current load with wire bandwidth.
[0137] Thin aluminum strips increase the surface
area/cross-sectional area ratio and the "skin" effect for
conduction. Aluminum strips (typically less than 0.003 inches
thickness) and of any width, but typically 2-10 mm, are mounted
onto a radio-lucent insulating material. The material is applied to
both sides of the strips. When shielding is required, a second
layer of thin aluminum material (typically less that 0.003 inches
thickness) is mounted onto each side of the insulated strip. The
shields are connected to provide a 360 degree shield. Multiple
conductor ribbons can be mounted in parallel to the insulating
layers. The insulating layers can be joined between each conductor
or left open, where insulation between conductors is obtained by
lack of contact due to the fixation to the insulating material.
Similarly, the shield can be connected on the sides of each
conductor or only on the sides of the conductor ribbon array.
[0138] The conductor starts with a sheet of foil, typically less
than 10 thousandths of an inch thick. The conductor may be aluminum
because it has less radio-opacity, although any conductor would
suffice (such as copper, iron alloys, gold, platinum, conductive
polymers, and carbon-based conductors). The roll of foil is divided
along its long axis into conducting tracts by cutting the foil with
a knife, laser or other means. The tracks are separated slightly
and mounted onto a non-conductive material, such a polypropylene.
This could occur as a continuous automated process. Then, a
non-conductive material is mounted to the opposite side of the
conductor, isolating the tracts electrically from each other and
from adjoining conductors. This could also occur as an automated
process, and also nearly simultaneously to the cutting and first
side application of the non-conductive material. Then, a foil of
conducting material, ideally aluminum, is applied to both the top
and the bottom of the enclosed conductor ribbon and joined at the
edges to create an electrical shield. This action could also occur
as an automated process at a similar time to the cutting, and
application of the non-conductive materials. Finally, a layer of
insulating material may be applied over the shield, as needed. That
material could consist of polymer, fabric or any flexible
insulating material and could occur as part of an automated
process.
[0139] In an alternative manufacturing process, strips of thin foil
precut to a desired dimension, could be joined to a non-conductive
surface instead of cut foil. In addition, the shield material could
be joined between conductor members to shield each conductor or set
of conductors individually. In addition, a single sheet of foil
could be placed around the insulated conductive ribbon and joined
to create a shield.
[0140] In another embodiment, fine wires arranged along the same
plane and positioned in contact with each other, or flat wire could
be used as the conductors.
[0141] In another embodiment, the insulating material is a
non-conductive paintable or spray-on material such as the array of
flat conductors could be coated and then placed directly on the
shield material.
[0142] In another embodiment, a pattern can be cut into the
conductor foil such that the conductors turn corners for
connections or to fit the contour of the housing into which it is
placed. In a further embodiment, the width of the tracts could be
varied based on the anticipated electrical signal to be carried by
the conductor. In a further embodiment, more than one layer of
divided foil conductors could be mounted on top of each other,
preserving the relative homogeneity of the x-ray absorption.
[0143] In a further embodiment, connection between conductors
within one foil or between foils would allow creation of electrical
circuits where on conductive track is connected to another. The
connection between conductors from one sheet to another can be
accomplished though a foil conductor. One problem encountered when
monitoring patients undergoing x-ray or MRI procedures is that the
wires are visible to x-ray or the electromagnetic field can induce
heating or current within the wire. Carbon nanotubes or variants
have been developed to provide electrical connections in the
environments. These conductors, however, and very expensive and
provide poor shielding from electromagnetic fields. In addition,
they tend to have poor conductivity, which is import when the
conducted signal is of low power.
[0144] In yet another embodiment, the conductors may be printed in
an array on a radiolucent insulative material, or both the
radiolucent material and the conductors may be printed in a manner
that lays down the insulative layers, conductive layers and
shielding layers to prevent cross-talk and create a single wiring
array construct.
[0145] One problem with reusable devices is contamination with
biologically active agents, such as bacteria, fungi, or viruses.
One method to reduce the burden of biologically active material is
application of certain frequencies of photons, such as ultraviolet
light. In this invention, a mattress is described where a light
source inside the mattress is used to sterilize the mattress
surface, by shining the light through a light transmitting
cover.
[0146] In one embodiment, the light emitters are fiber optic
strands woven into the cover. The strands have a removal of the
cladding at areas where the mattress needs to be sterilized. In one
embodiment, the cladding is removed preferentially on the side to
provide lateral photon dispersion, but no allow photons to escape
to the mattress foam, which might be damaging, or outside the
mattress. In another embodiment, to limit the radial movement of
the optical fibers and to improve durability, a bundle of two or
more fibers are contained in a jacket and woven into or adhered to
the mattress. In another embodiment, the jacket around the optical
fibers allows differential photon passage, such that UV C light can
be directed to the area that requires sterilization, but blocked to
areas of the mattress that are sensitive to UV C or outside the
mattress where it might damage bystanders.
[0147] UV C can be quite toxic to tissue and the present invention
has an integral sensor to determine if a person or object is on the
mattress. Such a sensor can be a weight or distortion detector,
such as a piezoelectric detector, a light based detector that
measures surface distortion, an infrared detector that detects body
heat, or a surface laser light device that detects the presence of
an object on the mattress surface. In another embodiment, a motion
sensor is used to detect people in the room and to interrupt the
photon emission. The motion detector is attached to the mattress in
one embodiment. In another embodiment, the motion detector is
remote from the mattress and communicates wirelessly or by
conductors. The motion detector can employ any of a number of
previously described methods, included sound or light
reflection.
[0148] Another means to sterilize the surface of patient mattresses
is the application of intense heat for a short period of time,
similar to Pasteurization of dairy products. In this invention, the
surface of the mattress is loaded with resistive heating wires
located close to each other. With the application of current
through the wires, the mattress surface heat rapidly. When on or
more thermistors located within the mattress reach a pre-specified
temperature, the current is reduced or interrupted. As an
alternative, a combination of temperature and time could be used to
signal that maximum effect had been achieved and effect a reduction
or elimination of further heating.
[0149] In an alternative embodiment, the heating elements are
attached to or layered under a heat conductive cover. This cover
can be composed of a metal, such as aluminum or a polymer, glass,
or fabric loaded with a heat conductor. The heat source would
provide heat energy and the conductor facilitates a more even
spread of the heat. This reduces the peak temperature and time
needed to treat because the heterogeneity of heat distribution is
reduced.
[0150] Alternatively, other heat sources can be used, such as a
heated fluid or air, and exothermic chemical reactions.
[0151] Safety measures similar to those described for use with UV C
sterilization may also be employed to prevent the activation of the
heat mattress disinfection when a patient or operator is in contact
with the mattress.
[0152] Determination of tissue oxygenation and blood flow has been
described and performed using a variety of methods, included pulsed
oximetry and laser Doppler methodology. Its application in a
medical and non-medical environments has allowed for monitoring of
patients in hospitals and clinics, and for monitoring of sleep
apnea and exercise performance. Monitoring requires the user to
attach a sensor to the skin. The sensors are usually handheld or
fixed to the skin with adhesive.
[0153] In this embodiment, a sensor is mounted in a mattress or
other device that people sit or lie on. The sensor sends and
receives its signal through a transparent window in the device onto
the subject body.
[0154] In a related device, the subject also wears a specialized
clothing that also contains a window for transmission and reception
of the signal, such that the signal can be transmitted through the
mattress or other device and then through the wearable
clothing.
[0155] Another embodiment is aimed at preventing pressure sores and
ulcers related to prolonged compression of skin and muscle while
laying down or sitting. Lack of blood flow leads tissue ischemia
and eventually necrosis. This embodiment includes a mattress
containing a multitude of sensors for oxygen concentration and/or
tissue blood flow. The sensors are located below the surface of the
device, but send and receive their signal through the surface of
the device in contact with the patient. The output from these
sensors is displayed visually on a monitor. In one embodiment, the
display is a color or greyscale coded picture of the support
structure, where the color or grey scale correspond to a range of
values from the sensor. In further embodiment, a similar display
shows a calculated value derived from multiple patient values. For
example, the product of blood flow and oxygen saturation. In
another example, a user or computer entered value such as the
patient's hemoglobin concentration or body surface area, would be
used in the calculated value that is displayed. In another example,
the calculated value could result from a calculation of one or more
user or computer entered values (such as height and weight), and
one or more sensed valves.
[0156] Patient undergoing medical procedures or surgical operations
usually lie on a mattress or sit in a chair. They are frequently
deeply sedated or completely unconscious for the procedure. The
head is often instrumented for placement of sensors (such as EEG
leads, temperature probes, and pulse-oximeter leads), control of
respiration using an endotracheal or endonasal tube, and various
devices that cannulate the stomach or esophagus (such as endoscopy
catheters, trans-esophageal ultrasound transducers or nasogastric
tubes). In some cases the head is covered by a sterile drape,
making access to the head and communication with the patient
cumbersome. Moreover, the head is poorly supported, leading
physicians to tape the head to the operating room table or
mattress.
[0157] The invention described here is a molded head support that
stabilizes the head and neck, while at the same time providing a
platform for the mounting of sensors (such as EEG, temperature,
pulse oximetry, ECG, video observation of the eyes and airways,
exhaled CO2), attachment of probes and tubes (such as endotracheal
tube, endoscopic devices, ultrasound devices, and tubing for
medical gasses), and communication with the patient (speakers and
microphone). The wires or fiberoptic connection to the sensors are
passed through the head support. In one embodiment, cables to
external devices are attached to the head support. In another
embodiment, the head support contains a radio transmitter that
transmits the sensor signal to the remote display device. In
another embodiment, the head support is attached by a cable or
optical fiber to the mattress, operating table, or rail attached to
the operating table or mattress.
[0158] Therapeutic hypothermia has been used to improve the outcome
of patients suffering cardiac arrest or circulatory collapse. By
slowing metabolism and oxygen consumption, organ salvage and
survival is enhanced. One problem is that cooling in the field has
been difficult and cooling in the hospital is often delayed by the
time it takes to apply the cooling equipment. In addition, cooling
of the brain, an essential organ very vulnerable to hypoxia, is
slowed by the skull, which is a heat sink. One embodiment includes
a head apparatus with one or more thermistors to sense the
cutaneous temperature of the skull. In addition, the body of the
apparatus contains one or more cavities. The cavity(s) are
connected to a pressurized gas reservoir and an exhaust canal. A
pressured valve can be actuated, whereby the pressurized gas flows
into the cavity(s) and due to the rapid pressure fall, the cavity
is rapidly cooled.
[0159] In one embodiment, the thermistor(s) control the flow of gas
to the cavity(s) individually or together by use of a feedback
loop, whereby the gas is controlled to achieve a set temperature.
This will prevent freezing of the scalp while achieving maximal
cooling. In another embodiment, a thermistor sensing core
temperature would also provide feedback to the regular valve(s) to
reduce flow when a set level of core or brain temperature was
achieved. Core temperature thermistors can be located in the
rectum, blood vessels, ear canal (as a tympanic membrane sensor),
and eyes (as a retinal temperature sensor, esophagus or other
locations.
[0160] In another embodiment, the gas flow chambers could be
perfused with a chilled fluid, with similar controls by the
thermistors feedback loop(s).
BRIEF DESCRIPTION OF THE DRAWINGS
[0161] These and other aspects, features and advantages of which
embodiments of the invention are capable of will be apparent and
elucidated from the following description of embodiments of the
present invention, reference being made to the accompanying
drawings, in which
[0162] FIG. 1--Image of the patient mattress showing the
configuration of the mattress components with a single arm board
and radiation shield installed.
[0163] FIG. 2--Image of the patient mattress with the inner comfort
foam component removed, revealing the rigid chest support
component.
[0164] FIG. 3--Image of the patient mattress with both arm boards
installed.
[0165] FIG. 4--Cross-sectional end view of the patient mattress
demonstrating one embodiment of the component assembly.
[0166] FIG. 5--Cross-sectional end view of the patient mattress
demonstrating another embodiment of the component assembly that
includes a hinged radiation shield.
[0167] FIG. 6--Alternate embodiment of the patient mattress
describing a neck and waist radiation shield component.
[0168] FIG. 7--Image of an integrated induction coil used to power
devices placed on the table.
[0169] FIG. 8--Image of an integrated induction coil as used in a
sterile field.
[0170] FIG. 9--Image of the work table with magnet configurations
used to hold devices within the sterile field.
[0171] FIG. 10--Cross-sectional end view of mattress demonstrating
attachment mechanisms used to connect radial table to patient
mattress.
[0172] FIG. 11--Cross-sectional end view of mattress demonstrating
attachment mechanisms used to mount a rotatable radial table to
patient mattress.
[0173] FIG. 12--Cross-sectional end view of mattress assembly
demonstrating raised edges to prevent patient falls.
[0174] FIG. 13--Cross-sectional end view of mattress assembly
demonstrating deflectable raised edges that may be used to aid in
patient transfer.
[0175] FIG. 14--Image of a deformable clip that can be used to hold
guidewires or catheters in a steady position on the table.
[0176] FIG. 15--Image of an alternate embodiment of a clip that
uses a mechanical ratchet to hold the clip closed on a guidewire or
catheter on the table.
[0177] FIG. 16--Image of an alternate embodiment of a clip that
uses a ball and socket attachment mechanism in conjunction with a
magnet to mount to the patient mattress or work table.
[0178] FIG. 17--Image of an alternate embodiment of a clip that
uses a compressible block with retention clips to hold a guidewire
or catheter on the table.
[0179] FIG. 18--Image of an alternate embodiment of a clip that
uses a compressible block with retention clips to hold a guidewire
or catheter on the table, shown open over a guidewire.
[0180] FIG. 19--Image of an alternate embodiment of a clip that
uses a compressible block with retention clips to hold a guidewire
or catheter on the table, shown closed upon a guidewire.
[0181] FIG. 20--Image of an integrated blood pressure cuff on the
arm board or table.
[0182] FIG. 21--Image of an integrated blood pressure cuff with
tubing connection on the arm board or table.
[0183] FIG. 22--End view image of a blood pressure cuff open,
closed and inflated.
[0184] FIG. 23--End view image of a blood pressure cuff during
use.
[0185] FIG. 24--Top view of the patient mattress with blood
pressure cuff positions described in serial fashion.
[0186] FIG. 25--Top view of the patient mattress with blood
pressure cuff positions described in parallel fashion.
[0187] FIG. 26--Image of a mattress with electrically conductive
regions or conductors for ECG use.
[0188] FIG. 27--Image of a rail configuration around the perimeter
of the patient mattress.
[0189] FIG. 28--Image of an alternate rail configuration around
portions of the perimeter of the patient mattress.
[0190] FIG. 29--Cross-sectional view of the rail, demonstrating
lines carrying gas, data and power.
[0191] FIG. 30--Cross-sectional view of the mattress, demonstrating
alternate rail configurations.
[0192] FIG. 31--Image showing a top view of the mattress with
rails, showing power connections and isolation locations.
[0193] FIG. 32--Image showing a top view of the mattress with
rails, showing a rechargeable battery within the rail.
[0194] FIG. 33--Image showing a top view of the mattress with
rails, showing a rechargeable battery within the mattress.
[0195] FIG. 34--Image showing a top view of the mattress with
rails, showing a gas line connection to the rail.
[0196] FIG. 35--Image showing a top view of the mattress with
rails, showing a gas system integrated into the rail.
[0197] FIG. 36--Image showing a top view of the mattress with
rails, showing a gas system integrated into the mattress.
[0198] FIG. 37--Image showing a top view of the mattress with
rails, showing a data and processing system integrated into the
rail.
[0199] FIG. 38--Image showing a top view of the mattress with
rails, showing a data and multi-processing system integrated into
the rail.
[0200] FIG. 39--Image showing a top view of the mattress with
rails, showing a data and processing system integrated into the
rail with wireless communication and a CPU integrated into the
mattress.
[0201] FIG. 40--Image of a patient lying atop the mattress with
radiation protection rollers across the waist and groin. Removable
cutouts are available for femoral access.
[0202] FIG. 41--Image of a patient lying atop the mattress with
radiation protection rollers across the waist and groin. Additional
rollers provide protection from radiation backscatter from the
shoulders and arms.
[0203] FIG. 42--Image of the roller mechanism and housing.
[0204] FIG. 43--Image of the roller mechanism and housing, with an
integrated grid within the roller to provide for fluoroscopic
landmarks.
[0205] FIG. 44--Image of a roller mechanism used to provide
contacts for a 12-lead ECG across the body of the patient.
[0206] FIG. 45--Image of the roller mechanism with the 12-lead ECG
in contact with the patient.
[0207] FIG. 46--First insulating layer of a flat wiring system.
[0208] FIG. 47--Second layer of flat wiring system, consisting of
film shielding to prevent electrical interference.
[0209] FIG. 48--Third layer of flat wiring system, consisting of a
second insulating layer.
[0210] FIG. 49--Fourth layer of flat wiring system, consisting of
flat ribbon wires from the point of ECG connection to the mattress
to the point of monitor connection to the mattress.
[0211] FIG. 50--Fifth layer of flat wiring system, consisting of a
third insulating layer.
[0212] FIG. 51--Sixth layer of flat wiring system, consisting of
additional flat ribbon wires from the point of ECG connection to
the mattress to the point of monitor connection to the
mattress.
[0213] FIG. 52--Seventh layer of flat wiring system, consisting of
a fourth insulating layer.
[0214] FIG. 53--Eighth layer of flat wiring system, consisting of a
second layer of film shielding to prevent electrical
interference.
[0215] FIG. 54--Ninth layer of flat wiring system, consisting of a
final insulating layer.
[0216] FIG. 55--Cross-sectional view of the wiring assembly,
demonstrating the relative position of the layered components.
[0217] FIG. 56--Image showing the configuration and components of
an integrated ultraviolet C system for mattress disinfection.
[0218] FIG. 57--Image showing the configuration and components of
an integrated heating system for mattress disinfection.
[0219] FIG. 58--Image demonstrating integrated pulse oximetry into
the mattress.
[0220] FIG. 59--Image showing the head nest system for the
mattress, containing speakers and rails.
[0221] FIG. 60--Image showing pulse oximetry and EEG connections in
the head nest system.
[0222] FIG. 61--Image showing audio, power and gas connections to
the head nest, as well as venting pattern for head cooling.
[0223] FIG. 62--Image showing full head capture for direct EEG
contact and more venting exposure for head cooling.
[0224] FIG. 63--Image showing flag radiation protection system with
regions of delfection.
[0225] FIG. 64--Image showing flag radiation protection system
integrated into the mattress system.
[0226] FIG. 65--Image showing workbench in relation to the
mattress, patient and backscattered radiation.
[0227] FIG. 66--Image showing workbench in relation to the
mattress, demonstrating rotation and tilt features.
[0228] FIG. 67--Image showing features of the workbench to
accommodate patient anatomy and aid in compression of vascular
access sites.
[0229] FIG. 68--Image showing workbench with adjustability of width
to accommodate a range of vascular access sites.
[0230] FIG. 69--Image showing another embodiment of the flag, with
articulating vertical keys to provide radiation protection.
[0231] FIG. 70--Image showing overhead and side views of the keys
relative to the x-ray detector.
[0232] FIG. 71--Image showing mechanism that provides flexion of
the rigid keys at the hinged base.
[0233] FIG. 72--Image showing integrated protection system to
prevent keys from being damaged by contact from the x-ray
detector.
DESCRIPTION OF EMBODIMENTS
[0234] Specific embodiments of the invention will now be described
with reference to the accompanying drawings. This invention may,
however, be embodied in many different forms and should not be
construed as limited to the embodiments set forth herein; rather,
these embodiments are provided so that this disclosure will be
thorough and complete, and will fully convey the scope of the
invention to those skilled in the art. The terminology used in the
detailed description of the embodiments illustrated in the
accompanying drawings is not intended to be limiting of the
invention. In the drawings, like numbers refer to like
elements.
[0235] FIG. 1 describes the configuration of one embodiment of the
mattress. There is a comfort foam component 2 housed within a
relatively rigid outer shell 1. Under the torso of the patient is a
more rigid component 3 that may be used to support chest
compressions. The ends of component 3 may also be used to mount
additional items to the mattress. In this embodiment, removable arm
boards 4 are designed to be placed on the ends of component 3. A
radiation protection wing 5 may be mounted to the arm board 4 to
prevent backscatter radiation from reaching the staff in the
cardiac catheterization laboratory.
[0236] FIG. 2 shows the mattress shell 1 with the patient comfort
component 2 removed. This demonstrates the location and orientation
of the rigid torso component 3.
[0237] FIG. 3 shows the patient mattress with a second arm board 4
mounted to the rigid component 3.
[0238] FIG. 4 shows a cross-sectional view of the mattress that
demonstrates one embodiment of the component assembly. The patient
comfort component 2 resides within the rigid shell 1. The rigid
torso component 3 crosses through the shell 1 and may be used to
mount the arm board 4 to the mattress assembly. The radiation
protection wing 5 is mounted to the arm board 4 using the receiving
slot 6, which holds the wing 5 in place with either a friction fit
or through the use of magnets or some other engaging mechanism.
Magnetically sensitive material or a magnet 7 on the arm board 4
can also be used to affix the arm board to the side of the rigid
shell 1 with a mating magnetic surface 8.
[0239] FIG. 5 shows a cross-sectional view of the mattress similar
to that of FIG. 4. In this case, the radiation protection wing 5
contains a spring loaded hinge 9 that will aid in the flexion of
the wing away from the mattress if a component of a fluoroscopy
unit comes into contact with it.
[0240] FIG. 6 shows additional components that are added to the
mattress to provide additional radiation protection. The neck
protection component 10 is placed near the head of the patient, and
contains a neck cutout 12 to provide for access to the jugular vein
for interventional cardiology procedures. The waist protection
component 11 is placed at the waist of the patient, and may contain
a femoral cutout 13 to allow for access to the femoral arteries or
veins in the groin.
[0241] FIG. 7 shows an induction coil 15 that can be mounted to any
working surface on the mattress, particularly the work table 14.
The induction coil 15 is powered through an integrated cable
16.
[0242] FIG. 8 shows a similar image to that of FIG. 7. A device
power source 17 is placed on a sterile drape 49 over the induction
coil 15. The system is designed to power that device via a power
cable 17 that is designed to be within the sterile field.
[0243] FIG. 9 demonstrates magnet patterns that may be used in
conjunction with the table 14. Individual magnets 19 may be
embedded in or fixed to the table 14. Magnetic bars 20 may also be
used in a similar manner. Dipole magnetic bars 21 may be also used
to ensure correct orientation of devices with similar magnets that
are affixed to the table 14. These magnets are all designed to hold
sterile components to the table 14 through a sterile drape 49.
[0244] FIG. 10 describes mounting mechanisms to hold a work table
14 or radial board 23 to the edge of the rigid shell 1. A rail 22
mounted to the edge of the rigid shell 1 provides an attachment
surface that can be used as an attachment point. A latch and
release mechanism 24 can be used to reversibly attach the radial
board 23 to the rail 22. The latch and release mechanism 24, along
with the attachment surface of the guiderail, are constructed and
arranged, in one embodiment, such that accessories equipped with
the latch and release mechanism, such as a table, arm rest,
instrumentation, radiation shields, monitors, and other equipment,
may be easily attached to the guiderail and slid down the length of
the guiderail to an optimal position before being locked in place.
Additionally, a secondary support mechanism may be used to provide
additional support to carry loads on the radial board 23.
[0245] FIG. 11 describes a similar configuration to that of FIG.
10, with the addition of a hinge mechanism 27 which allows for the
radial board 23 to be rotated downward for stowing when not in use.
The hinge mechanism 27 is activated by pressing or pulling the
release mechanism 26.
[0246] FIG. 12 demonstrates a mattress configuration to aid in
patient transfer and to prevent inadvertent patient falls from bed.
The rigid shell 1 has raised edges 28 and 29 that will resist a
patient fall. These edges may be of flexible material and be able
to flex out of the way, or be more rigid and have a parting line 30
where the material can more easily displace.
[0247] FIG. 13 describes a similar configuration to that of FIG.
12, with the addition of a locking mechanism 31 that can be used to
hold the displaced edge of the rigid shell 1 during patient
transfer. This locking mechanism 31 holds the edge 29 in a lateral
position to facilitate sliding a patient onto or off of the
mattress 2 from a gurney.
[0248] FIG. 14 describes one embodiment of a clip used to aid in
holding guidewires or catheters during interventional procedures.
The body of the clip 33 is an elastomer that is partially split.
The gap 50 created by the split and the slit 51 may be used to hold
a guidewire or catheter 54 in a defined position. A magnetic base
32 is affixed to one surface of the clip to allow the clip to be
reversibly attached to a work surface beneath a sterile drape
within the sterile field of a catheterization procedure.
[0249] Another embodiment of a clip mechanism is shown in FIG. 15.
In this embodiment, a first half 35 and a second half 36 are
mounted to a magnetic base 32. Embedded in or attached to each half
is a supporting post 37 that is mounted to the base 32. This
mounting mechanism may include a hinge 38, or the posts may be of a
flexible material that allow for bending. A ratchet mechanism 39
bridges the gap between the first half 35 and the second half 36. A
guidewire or catheter 34 may be placed within the gap 50 between
the first half 35 and the second half 36. When the first half 35
and the second half 36 are pressed towards one another, the ratchet
mechanism 39 engages, holding the halves together and holding the
position of the catheter or guidewire 34.
[0250] In yet another embodiment of a clip mechanism shown in FIG.
16, a secondary attachment mechanism may be used to supplement or
replace the magnetic base 32 of the clip. A post containing a ball
40 may be mounted below the magnetic base 32. This ball 40 can be
reversibly inserted into a receiving cup 42 on a work surface 41.
This construct allows for rotation of the entire clip assembly 52,
to better align the clip to a catheter or to manipulate the
position of the holder during use.
[0251] FIG. 17 describes another embodiment of a clip mechanism. A
compressible block 43 contains a slit 45 for receiving a guidewire
or catheter 34. Two lever arms 44 and 53 are mounted to the sides
of the compressible block 43 that each have a clip lock edge 47 for
engagement with the tapered block surface 46. The lever arms
contain cutouts to allow for the guidewire or catheter 34 to sit in
the bottom of the slit 45.
[0252] FIG. 18 shows the guidewire or catheter 34 placed within the
slit 45, prior to engagement of the lever arm clips.
[0253] FIG. 19 shows the engagement of the compressive block 43 on
the guidewire or catheter 34. The ends of the compressible block 43
are squeezed towards one another, enabling the clip lock edge 47 of
the lever arms 44 and 53 to slide along the tapered surface of the
compressible block 43. When the clip lock edges 47 extend beyond
the end of the compressible block 43, the clip lock edges latch
onto the end of the compressible block and hold it in a compressed
position. This compression engages the guidewire or catheter 34 and
maintains it in a fixed position. To disengage the clip from the
guidewire or catheter 34, the ends of the lever arms 44 and 53 are
squeezed towards one another, releasing the clip lock edges 47 from
the end of the compressible block 43 and opening the slit 45.
[0254] FIG. 20 shows a blood pressure cuff 68 designed to be added
as a component to the patient mattress. The outer shell 60 of the
cuff is mounted to the table or arm board 65, and contains a hinge
61 that allows the outer shell 60 to open and close at the parting
line 62 in a clamshell fashion to allow the arm of the patient to
be inserted without necessitating sliding the device over the hand
and arm of the patient. Clasps or magnetic attachments 63 located
at the part line 62 hold the outer shell 60 closed after arm
insertion. The air bladder 64 is retained within the outer shell
60.
[0255] FIG. 21 shows a side view of the blood pressure cuff 68,
with the outer shell 60 mounted to the arm board 65. Blood pressure
air tubing 66 is run along the surface of the arm board 65 or
embedded within, leading from the outer shell 60 to a tubing
connection 67 integrated into the arm board 65.
[0256] FIG. 22 demonstrates how the blood pressure cuff 68 is used.
The outer shell 60 opens in a clamshell fashion about the hinge 61.
Once the arm of the patient is inserted into the clamshell, the
outer shell 60 is closed and the opposite surfaces of the parting
line 62 are affixed to one another with clasps or magnetic
attachments 63. Once closed and locked, the air bladder 64 may be
inflated in order to obtain patient blood pressure.
[0257] FIG. 23 demonstrates the measurement of blood pressure
during the use of the blood pressure cuff 68. When the air bladder
64 is inflated fully, blood flow through the arm is stopped. As the
pressure in the air bladder 64 drops below systolic blood pressure,
blood flow will begin in an intermittent fashion. The air pressure
in the system is then equated to peak systolic pressure. As the air
pressure continues to drop, the air pressure in the air bladder 64
drops below diastolic pressure and continuous blood flow is
observed. This air pressure in the system is equated to diastolic
pressure.
[0258] FIG. 24 demonstrates where these blood pressure cuffs 68 may
be integrated into the mattress. Air tubing 70 is integrated into
the mattress 69, leading from a junction box 72 that connects to
the pump and sensor to the valved receptacle 71 used for connecting
the blood pressure cuff 68. These blood pressure cuffs 68 are
connected to the receptacle 71 using air tubing 66. Locations of
the cuff may be placed such that they can be used for either arm or
either leg.
[0259] FIG. 25 demonstrates how the integrated blood pressure cuffs
68 can be controlled to ensure that pressure is being read from an
active location. A pressure sensing control can be integrated into
the integrated air tubing 70 such that the junction box 72 will
pick up pressure oscillations and open the junction valve to the
active tube. Alternately, a conductor 73 may be used at each local
connection receptacle 71 to communicate with the junction box 72
that a connection to a pressure cuff tube 66 has been made,
activating that pressure line 70.
[0260] FIG. 26 shows electrically conductive components integrated
into the mattress. The electrodes 81 are embedded into the surface
of the mattress 69 with conductive wires 83 running to a junction
box 84 for connection to a monitoring system. A drape 80 is placed
over the mattress 69, with the drape containing electrically
conductive regions 82 through which the electrical connection from
the patient to the electrodes 81 may be made. In order to ensure
alignment of the conductive regions 82 to the electrodes 81,
reference markers 86 are placed at the edges to match up with
markers on the mattress 69. Additional reference markers 85 on the
drape 80 show the areas where the electrodes 81 are placed, to
ensure proper patient positioning.
[0261] FIG. 27 demonstrates one embodiment of the patient mattress
69 in which the integrated rails 111 extend the length of the
mattress 69 along either side. The wing 5 is attached with the arm
board 4 to the rail 111 on the right side of the patient 150. The
waist radiation protection component is in the form of a flag 100
that is mounted to the rail 111 on the patient left side. A patient
workbench 250 is also mounted to the rail 111 on the patient left
side and resides across the waist and groin area of the patient
150.
[0262] FIG. 28 demonstrates an alternate embodiment of the patient
mattress 69 in which integrated rails 111 are mounted to the sides
and end of the outer shell 1.
[0263] FIG. 29 shows a cross-sectional view of the rails 111
integrated with the outer shell 1 via a rigid connector 112. Within
the rail 111 and the connector 112 resides a gas line 113 that
terminates at a regulator 114 which can communicate with tubing to
the patient. Also housed within the rail 111 and connector 112 is a
power line 117 that comes from within the outer shell 1 and
terminates in a power connection 118 that may be used to power
devices for patient monitoring or care. The rail 111 also houses a
data line 115 that terminates in a data connector 116 that can be
used to transfer data to and from the patient.
[0264] FIG. 30 describes methods in which the rail 111 may be
mounted relative to the mattress 69. The rail 111 may be mounted to
the outer shell 1 via rail supports 112 that affix to the outer
shell 1, with the rail 111 recessed within the body of the outer
shell 1. There may also be a lateral support 107 that traverses
between rails 111 on either side of the outer shell 1. Alternately,
the rail 111 may have a secondary support 106 to the outer shell 1,
and may also have a rigid member 108 along the inner perimeter of
the outer shell 1 that connects the two rails 111 together.
Finally, as shown in this figure the rail 111 may or may not be
recessed into the outer shell 1.
[0265] FIG. 31 details a power system that is integrated into the
rail 111. The rail 111 is affixed to the outer shell 1 of the
mattress system 69 by rail supports 112. Attached to the rail 111
is a power connection 109 to an outside source. Within the rail 111
is a power isolation and conditioner 110 that is used for voltage,
polarity or transforming from alternating to direct current. A
power line 117 runs through the rail system and power outlet
connections 118 are placed in areas of need along the perimeter of
the mattress 69 within the rail system 111.
[0266] FIG. 32 describes a power system similar to that of FIG. 31,
with an internal power supply. A rechargeable/replaceable battery
136 is integrated into the rail in place of the external power
connection 109, allowing the mattress system more portability.
[0267] FIG. 33 describes a portable power system similar to that of
FIG. 32, but with a battery 119 that is housed within the inner
comfort component 2 of the mattress system 69. A detachable
charging cable 120 can provide for the ability to recharge the
battery 119 when necessary.
[0268] FIG. 34 describes how the rail system 111 can be used to
transfer gas to the patient. Gas from an outside source is
connected to the rail via the connector 121 and a gas regulator 122
is integrated into the rail 111. A gas line 123 runs through the
rail 111 and gas output valves 124 are placed in areas of need
along the perimeter of the mattress system 69.
[0269] FIG. 35 describes a gas system similar to that of FIG. 34,
but with the gas supply housed within or attached to the rail 111
itself. A gas source 125 is mounted within or on the rail 111, with
a gas regulator 122 used to manage gas pressure and flow.
[0270] FIG. 36 describes a gas system similar to that of FIG. 35,
but with the gas source 125 housed within the inner comfort
component 2 of the mattress system 69.
[0271] FIG. 37 describes how the rail system 111 may be used to
carry data. A data connection 126 from an outside source is
connected to the rail 111, and a data processing CPU (physiologic
monitor, connection to hospital IT or a device controller) is
housed within the rail. A data line 128 runs through the rail
system 111, and data outlet connections 129 are placed in areas of
need around the perimeter of the mattress system 69.
[0272] FIG. 38 describes a rail data and processing system with
data isolation, multiple processors and a user interface integrated
into the rail. Data is connected from an outside source 126, where
an electrical isolation 130 and a data processing CPU 127 are
mounted. Data is carried through the rail 111 via a data line 128,
and data outlet connections 129 are mounted within the rail at
locations where needed. A user interface 132 is mounted where
accessible by the health care staff, and a second CPU 131 may also
be integrated into the rail to provide additional computing power.
In addition, devices may communicate with each other directly
thought the rail data line. In addition, the user may control
devices on the rail data system or send commands to elements
connected to the data line 126 through user interface 132.
[0273] FIG. 39 describes a system similar to that of FIG. 38, with
an alternate embodiment in which the CPU 134 is mounted within the
patient comfort component of the mattress 2, and connected to the
rail via a data line 135. The data communication to the outside in
this embodiment is in the form of a wireless data transmitter and
receiver 133.
[0274] FIG. 40 shows a system of radiation protection integrated
into the mattress system 69. A sheet of radiation protective
material 155 is draped across a subject 150 lying on the mattress
69. This radiation protective material 155 is housed within a
roller 154 when not in use. It is affixed across the table using a
connector 151, which may be a hook or a magnetic attachment. Sites
for femoral vessel access are placed in the radiation protective
sheet 155 at the location of the left femoral 152 and the right
femoral 153 arteries and veins. Access sites that are not used for
a procedure may be closed off to prevent radiation backscatter from
emitting through the access sites.
[0275] FIG. 41 shows a system of radiation protection similar to
that of FIG. 40, with additional radiation backscatter protection
provided by roller sheets of radiation protection material 155
draped over the shoulders of the subject 150 from rollers 156
mounted at the head of the mattress system 69. These may be held in
place by weighted pads or magnets 168 integrated into the end of
the radiation protection material 155. In addition the shoulder
radiation protection sheet may be attached to the femoral roller
sheet 155 using hooks, clasps, zippers or magnets.
[0276] FIG. 42 shows one embodiment of the roller 154 in which the
radiation protection material 155 is stored within a container of
sterilization fluid 159 to prevent bacterial or viral contamination
from being passed from patient to patient.
[0277] FIG. 43 shows an embodiment of the roller 154 in which the
radiation protective material 155 also contains a grid and dot
marker matrix 159 on the sheets which are visible using fluoroscopy
so that the grid may be used for reference location or
measurement.
[0278] FIG. 44 shows an embodiment of a roller system 154 in which
the material on the roller is not radiation protective 155, but
rather an electrically conductive film array 169. The subject on
the mattress 150 has conductive patches 160 placed for an ECG in
the areas of interest. As the roller material is draped across the
subject on the mattress 150 and connected to the far side of the
table 151, the conductive patches 160 come in contact with the
conductive film array 169. The system senses which areas of the
array are receiving an active signal and that data is sent to
create the ECG. In another embodiment, the roller shield is both
electrically conductive and provides radiation protection.
[0279] FIG. 45 provides an additional embodiment of the ECG
construct. An ECG processing unit 166 is mounted to the mattress
69. The conductive film array 169 communicates with the processing
unit 166. Conductive patches 162 that are not in contact with the
conductive array film are connected with the processing unit 166
with traditional leads 165.
[0280] FIG. 46 describes the first layer of a flat wiring system
for use in a fluoroscopic field. This layer is an insulator 175,
preventing electrical contact with adjacent materials. In one
embodiment it is a polymeric film. It is shaped to fit the inner
surfaces of the outer shell 1 of the mattress system.
[0281] FIG. 47 describes the second layer of a flat wiring system.
This layer is electrical shielding 176, in one embodiment being
composed of aluminum film.
[0282] FIG. 48 describes the third layer of a flat wiring system.
This layer is an insulator 175, preventing contact between the
shielding and the conductors.
[0283] FIG. 49 describes fourth layer of a flat wiring system,
including the head side ECG leads. The left 177, center 178 and
right 179 leads lay atop the insulator 175 and do not come into
contact with each other.
[0284] FIG. 50 describes the fifth layer of a flat wiring system.
This layer is an insulator 175, preventing contact between the lead
layers.
[0285] FIG. 51 describes the sixth layer of a flat wiring system.
This layer contains additional chest leads and arm/leg leads. These
leads do not come into contact with each other and terminate at ECG
locations within the mattress shell 1.
[0286] FIG. 52 describes the seventh layer of a flat wiring system.
This layer is an insulator 175, preventing contact between the
conductors and shielding.
[0287] FIG. 53 describes the eighth layer of a flat wiring system.
This layer is electrical shielding 176, in one embodiment being
composed of aluminum film.
[0288] FIG. 54 describes the ninth layer of a flat wiring system.
This layer is an insulator 175, preventing contact between the
shielding and adjacent materials.
[0289] FIG. 55 is a cross-sectional end view of the flat wiring
system, showing the relative positions of the insulation 175,
shielding 176 and ECG leads 177-184.
[0290] FIG. 56 describes a system for integrating UV C
sterilization into the patient mattress system 69. In one
embodiment, optical fibers 190 are interwoven or embedded into the
mattress surface with a removable light shield 191 used as one
means to protect the health care workers from UV exposure. In
another embodiment, the optical fibers are cladded with a shielding
material 192, which is partially removed from the fiber in order to
provide directional shielding from the UV rays.
[0291] FIG. 57 describes a system for integrating heat
sterilization into the patient mattress system 69. Heating elements
195 are integrated into the surface of the mattress and a heat
conductor 196 diffuses the heat throughout the mattress surface.
Heat sensors 197 are used to ensure that the heat is sufficient for
sterilization, and provide a safety mechanism to prevent activation
of the heating system if a patient is on the mattress system
69.
[0292] FIG. 58 describes a system for integrating pulse oximetry
into the patient mattress system 69. Pulse oximetry
emitter-detectors 200 are placed within the mattress and the
mattress system 69 is draped with a clear drape 202. Light 201 is
emitted by the emitter-detectors 200 through the clear drape 202 to
the skin of the patient and the response picked up by the
emitter-detector 200 is used to determine blood oxygen content. In
an alternate embodiment, the emitter-detectors 200 emit coherent
light where changes in reflected light frequency are used to detect
tissue blood flow.
[0293] FIG. 59 describes a head component 210 to be used with the
mattress system 69. This is intended as a type of pillow, with
additional functionality for the health care environment. In one
embodiment, this head component 210 contains speakers 212 and a
microphone 213 for communication between the patient and the health
care staff. The head component 210 also has rails 211 affixed to
it, to allow for mounting of equipment (EEG, camera, pulse
oximetry) near the head of the patient.
[0294] FIG. 60 describes further features of the head component
210. There are EEG lead connection sites for input 216 and output
217, as well as pulse oximetry input 214 and output 215
locations.
[0295] FIG. 61 describes a further embodiment of the head component
210. There are locations for audio in and out 221 as well as a
power supply 222. Additionally, the head component 210 may be used
for hypothermic head cooling, in which gas can be connected to the
head component 210 via a gas connector 224, and cooling gas may be
driven through vent holes 223 to cool the scalp. Temperature
sensors 225 on the head component may be used to automatically
drive gas flow until the scalp reaches a preferred temperature.
[0296] Alternately, as shown in FIG. 62 the head component 210 may
fully encapsulate the head, using a scalp component 219 that can
provide direct EEG contact, as well as a modular neck component 220
that can restrain the head. This fully encapsulated system can
provide more surface for the cooling vents 223 as well.
[0297] FIG. 63 describes a radiation protection flag designed to
reside over the patient, positioned across the width of the table.
The lower unit 231 is relatively rigid, with a cutout for the
patient anatomy 233, in this case the groin for femoral vascular
access. The upper unit 230 is attached to the lower unit 231 by a
hinge mechanism 234 that allows the top of the upper unit 230 to
flex or rotate towards the head 236 or towards the feet 235 of the
patient relative to the lower unit 231. A lateral unit 232 that may
be made as a solitary component or with upper and lower units is
attached to the rest of the flag by a vertical hinge 238 that
allows for rotation of the outer edge towards the head or feet of
the patient. A cutout 237 in the bottom of the lateral unit 232
accommodates the arm of the patient for radial vascular access.
[0298] FIG. 64 shows the radiation protection flag in position on
the patient mattress 69. The lateral unit 232 sits over the right
arm of the patient 150, with the cutout 233 residing over the
patient waist or groin. The vertical hinge 238 allows for flexion
of the lateral unit 232 to better wrap around the patient 150 and
to provide more complete radiation protection.
[0299] FIG. 65 shows a perspective end view of the workbench 250
over the patient 150 on the mattress 69. The workbench 250 is
radiation protective to prevent x-ray photons 251 from
backscattering from the patient out to the health care staff. The
workbench is mounted to the rail 111 using a vertical connection
mechanism 252 by which the device may be reversibly affixed. The
workbench is designed to provide multiple degrees of freedom in
order to allow adjustments for height, rotation and tilt.
[0300] FIG. 66 shows top 256 and side 255 views of the workbench.
In the side view 255, the workbench 250 can be rotated 253 about
the vertical post 252. In the top view 256, cutouts 257 in the
workbench 250 for femoral vessel access are shown. This workbench
250 is connected to the rails 111 in such a way that the workbench
250 may be rotated 253 over the patient 150 away from the operator
254 in order to gain access to the patient 150 or to facilitate
patient transfer to or from the mattress 69.
[0301] FIG. 67 demonstrates side views 259 of the workbench 250
with a compression feature 258 to apply pressure to the patient
(for example, to stop bleeding). When deflated, the compression
feature 258 does not come into contact with the patient 150. When
inflated, the compression feature 258 comes into contact with the
patient, with the workbench 250 supporting the compression feature
258 such that active compression is placed on the leg of the
patient. This compression may be used to prevent blood loss through
a vascular access site after removal of catheters.
[0302] FIG. 68 demonstrates a feature in which the workbench 250
may be expanded in size to change the relative positions of the
femoral access cutouts 257 for various sized patients. In one
embodiment, lateral workbench components 259 and 260 may be
extended or retracted relative to a center component 261 in order
to create a wide configuration 262 or a narrow configuration
263.
[0303] FIG. 69 demonstrates an embodiment of the flag 280 in which
the radiation protection component of the flag is constructed of a
series of rigid components or keys 281 that interlock and interact
with one another. These keys 281 may be constructed of transparent
material, opaque material or a combination of the two. Many of the
keys have an element of transparent radiopaque glass 282 and an
adjacent element of visually and radiation opaque material 283
rigidly attached to one another. These keys 281 are each attached
to a lateral bar 284 by a hinge 285 that allows for rotational
motion of the keys 218 about the axis of the lateral bar 284. The
system contains a swivel 286 that allows the flag 280 to rotate
about a vertical support bar 287. At the patient right arm side,
there is a hinge 288 that allows for rotation about a vertical axis
to adjust the shape of the flag 280. There are overlapping rigid
plates 289 with a cutout for the patient arm 290 that allows for
height adjustment. Below the lateral bar 284 there are elements of
flexible radiopaque material 291 that allow for the shielding to
accommodate the shape of the patient. There are also additional
swivel elements 292 and 293 that provide for additional degrees of
freedom, allowing rotation in horizontal and vertical planes
respectively.
[0304] FIG. 70 demonstrates how the flag embodiment 280 performs
during use. The vertical hinge 288 allows the most lateral keys 281
of the flag to be flexed to accommodate the table and patient
anatomy while continuing to provide good radiation protection to
the health care staff. When the x-ray system 295 is advanced into
contact with the flag 280, the keys of the flag 281 which are
contacted by the x-ray system 295 flex about a lateral hinge 285,
deflecting the key 281 which can consist of a radiopaque
translucent component 282 and a radiopaque and visually opaque
component 283.
[0305] FIG. 71 describes the assembly details of one embodiment of
the radiopaque key mechanism. The transparent radiopaque material
282 may be a leaded glass with a thickness of about 7 mm. This
leaded glass is housed in a perimeter casing 300 of a polymer or
other structurally protective material. A liner material 391
resides under the glass at the base of the key 281 to protect the
glass from vibration or impact. The hinge 285 is mounted to the
lateral arm 284 using a set screw mechanism 302. This hinge 285 is
mounted to the glass casing 300 with a hinge hasp 303 that is
bolted through the glass 282 into a receiving plate 304. The glass
282 is protected from the bolt 305 by a bearing sleeve 306 and a
nylon spacer 307.
[0306] FIG. 72 describes some detail as to the construction of the
transparent/opaque assembly of the key 281. A front view 310 of the
assembly shows the glass 282 and the opaque component 283 housed
within a protective outer shell 300. A side view 309 of the
assembly shows how an inner layer of radiopaque material 311 can be
sandwiched within layers of a lightweight filler material 312 to
create an assembly of constant thickness.
[0307] Although the invention has been described in terms of
particular embodiments and applications, one of ordinary skill in
the art, in light of this teaching, can generate additional
embodiments and modifications without departing from the spirit of
or exceeding the scope of the claimed invention. Accordingly, it is
to be understood that the drawings and descriptions herein are
proffered by way of example to facilitate comprehension of the
invention and should not be construed to limit the scope
thereof.
* * * * *