U.S. patent application number 14/506186 was filed with the patent office on 2015-01-22 for drug delivery in association with medical or surgical procedures.
This patent application is currently assigned to Scott Laboratories. The applicant listed for this patent is Scott Laboratories. Invention is credited to Randall S. Hickle.
Application Number | 20150025494 14/506186 |
Document ID | / |
Family ID | 22207570 |
Filed Date | 2015-01-22 |
United States Patent
Application |
20150025494 |
Kind Code |
A1 |
Hickle; Randall S. |
January 22, 2015 |
DRUG DELIVERY IN ASSOCIATION WITH MEDICAL OR SURGICAL
PROCEDURES
Abstract
Disclosed are various methods and devices for facilitating
medical and/or procedures that are performed without "general
anesthesia," which is also described in the specification as the
state of patient "unconsciousness" resulting from a drug
administered by an anesthetist or anesthesiologist. The devices
safely and effectively provide and maintain drug infusions that do
not push the patient into unconsciousness and/or general
anesthesia. Devices according to embodiments of the invention
include the use of stored parameters and/or values that correlate
to drug delivery during a procedure, and a patient health monitor
to measure and send signals regarding a patient health condition to
a processor or other computational device.
Inventors: |
Hickle; Randall S.;
(Lubbock, TX) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Scott Laboratories |
Lubbock |
TX |
US |
|
|
Assignee: |
Scott Laboratories
Lubbock
TX
|
Family ID: |
22207570 |
Appl. No.: |
14/506186 |
Filed: |
October 3, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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11727575 |
Mar 27, 2007 |
8882703 |
|
|
14506186 |
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|
10909435 |
Aug 3, 2004 |
7201734 |
|
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11727575 |
|
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09324759 |
Jun 3, 1999 |
6807965 |
|
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10909435 |
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60087841 |
Jun 3, 1998 |
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Current U.S.
Class: |
604/503 |
Current CPC
Class: |
A61M 2205/18 20130101;
A61B 5/162 20130101; A61M 19/00 20130101; A61B 5/4821 20130101;
A61M 16/0084 20140204; A61M 16/026 20170801; A61M 2205/3379
20130101; A61M 16/1015 20140204; A61M 2016/1025 20130101; A61M
2230/43 20130101; Y10T 428/24355 20150115; A61M 16/01 20130101;
A61M 2205/276 20130101; A61M 2230/205 20130101; A61M 16/107
20140204; G16H 20/17 20180101; A61B 5/417 20130101; A61M 16/009
20130101; A61M 2016/0027 20130101; A61M 2205/3561 20130101; A61M
2209/084 20130101; A61M 16/0078 20130101; A61B 5/1106 20130101;
A61M 2230/432 20130101; G16H 40/63 20180101; A61M 2016/0036
20130101; A61M 2205/505 20130101; A61M 16/0051 20130101; A61M
2205/3303 20130101; A61M 16/0093 20140204 |
Class at
Publication: |
604/503 |
International
Class: |
A61M 19/00 20060101
A61M019/00 |
Claims
1. A method of providing effective sedation and/or pain relief
without general anesthesia by a non-anesthetist to a non-intubated
patient during a medical and/or surgical procedure, said method
comprising: infusing into the general circulatory system of said
non-intubated patient with a sedative and/or pain relieving drug
dosage that is insufficient to result in general anesthesia;
sensing at least one physiological condition of the patient during
and/or after said procedure; generating a signal in the event said
physiological condition of said patient becomes unsafe; modifying
said infusion of said drug so as to return said patient to a safe
physiological condition, and enabling said non-anesthetist to
manually alter the rate of infusion during and after said procedure
at any dosage level that is insufficient to result in general
anesthesia and as long as the patient's physiological condition
does not become unsafe.
2. The method as recited in claim 1 in which said generated signal
comprises an audible alarm.
3. The method as recited in claim 1 in which said modification of
said infusion is performed manually.
4. The method as recited in claim 1 in which said modification of
said infusion is performed automatically in response to said
signal.
5. The method as recited in claim 1 in which said modification is
controlled electronically.
6. The method as recited in claim 1 in which said drug is selected
from a group comprising fentanil, remifentanil, propofol, and
morphine.
7. The method as recited in claim 1 in which said drug is a mixture
of drugs selected from a group comprising fentanil, remifentanil,
propofol and morphine.
8. A method of providing effective sedation and/or pain relief by a
non-anesthetist without general anesthesia to a non-intubated
patient during a medical and/or surgical procedure, said method
comprising: infusing said non-intubated patient with a sedative
and/or pain relieving drug at a dosage rate that is insufficient to
result in general anesthesia; sensing at least one physiological
condition of the patient during said procedure with one or more
monitors selected from the following: pulse oximeter, heart rate,
blood pressure, carbon dioxide, EEG, and ventalatory; generating a
signal in the event of a change in said physiological condition;
controlling said infusion of said drug in response to said change
in said physiological condition.
9. The method as recited in claim 8 in which the controlling of
said infusion is performed manually.
10. The method as recited in claim 8 in which said drug comprises
propofol.
11. A method of providing sedation and/or pain relief by a
non-anesthetist including the procedural physician without general
anesthesia to a patient during a medical and/or surgical procedure
without general anesthesia, said method comprising: infusing said
patient with a sedative and/or pain relieving drug that is
insufficient to result in general anesthesia; electronically
sensing at least one physiological condition of the patient during
said procedure; electronically monitoring said sensing of said
physiological condition to determine if said sensing is safe and
generating a signal in the event said physiological condition
becomes unsafe, said signal directing how to modulate said rate to
avoid said unsafe condition while maintaining effective sedation
and/or pain relief; and means for enabling said non-anesthetist to
modify said infusion of said drug in accord with said signal so as
to return said patient to a safe physiological condition while
maintaining said sedation and/or pain relief.
12. The method as recited in claim 11 in which said drug is
propofol.
13. A method as recited in claim 11 in which said drug is
remifentanil.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of application Ser. No.
11/727,575 filed Mar. 27, 2007, now U.S. Pat. No. ______ which is a
continuation of U.S. patent application Ser. No. 10/909,435, filed
Aug. 3, 2004, now U.S. Pat. No. 7,201,734, issued Apr. 10, 2007,
which is a continuation of U.S. patent application Ser. No.
09/324,759, filed Jun. 3, 1999, now U.S. Pat. No. 6,807,965, issued
Oct. 26, 2004, which application claims priority to U.S.
Provisional Ser. No. 60/087,841, filed Jun. 3, 1998.
BACKGROUND OF THE INVENTION
[0002] This invention relates generally to an apparatus and method
for relieving patient pain and/or anxiety. More particularly, this
invention relates to a system and method for providing sedation,
analgesia and/or amnesia to a conscious patient undergoing a
painful or anxiety-producing medical or surgical procedure, or
suffering from post-procedural or other pain or discomfort. The
invention electronically integrates through conservative software
management the delivery of one or more sedative, analgesic or
amnestic drugs with the electronic monitoring of one or more
patient physiological conditions. In one form, the invention
includes the use of one or more sets of stored data-defining
parameters reflecting patient and system states, the parameters
being accessed through software to conservatively manage and
correlate drug delivery to safe, cost effective, optimized values
related to the conscious patient's vital signs and other
physiological conditions.
[0003] This invention is directed to providing a conscious patient
who is undergoing a painful, uncomfortable or otherwise frightening
(anxiety-inspiring) medical or surgical procedure, or who is
suffering from post-procedural or other pain or discomfort, with
safe, effective and cost-effective relief from such pain and/or
anxiety. Focuses of the invention include, but are not limited to,
enabling the provision of sedation (inducement of a state of calm),
analgesia (insensitivity to pain) and/or amnesia to a conscious
patient (sometimes referred to collectively as "conscious
sedation") by a nonanesthetist practitioner, i.e., a physician or
other clinician who is not an anesthesiologist (M.D.A.) or
certified nurse anesthetist (C.R.N.A.), in a manner that is safe,
effective and cost-effective; the provision of same to patients in
ambulatory settings such as hospital laboratories, ambulatory
surgical centers, and physician's offices; and the provision of
patient post-operative or other pain relief in remote medical care
locations or in home care environments. To those ends, the
invention mechanically integrates through physical proximity and
incorporation into an overall structural system and electronically
integrates through conservative, decision-making software
management, the delivery of one or more sedative, analgesic or
amnestic drugs to the patient with the electronic monitoring of one
or more patient physiological conditions.
[0004] In traditional operating rooms, anesthesiologists provide
patients relief from pain, fear and physiological stress by
providing general anesthesia. "Anesthesia" is typically used (and
is so used herein) interchangeably with the state of
"unconsciousness." Over a billion painful and anxiety-inspiring
medical and surgical procedures, however, are performed worldwide
each year without anesthesia. Thus, outside the practice of
anesthesiology there are currently a large number of patients who,
while conscious, undergo medical or surgical procedures that
produce considerable pain, profound anxiety, and/or physiological
stress. Such medical or surgical procedures are often performed by
procedural physicians (nonanesthetists) in hospital laboratories,
in physicians' offices, and in ambulatory surgical centers. For
example, physician specialists perform painful procedures on
conscious patients such as pacemaker placement, colonoscopies,
various radiological procedures, microlaparoscopy, fracture
reduction, wound dressing changes in burn units, and central and
arterial catheter insertion in pediatric patients, in hospital
laboratory settings. Primary care physicians perform such
procedures as flexible sigmoidoscopies, laceration repairs, bone
marrow biopsies and other procedures in physicians' offices. Many
surgical specialists perform painful procedures such as anterior
segment repairs by ophthalmologists, plastic procedures by cosmetic
surgeons, foreign body removal, transurethral procedures, incisions
of neck and axilla nodes, and breast biopsies in their offices or
in ambulatory surgical centers. The needs of patients for safe and
effective pain and anxiety relief during and after such procedures
are currently unmet.
[0005] Conscious sedation techniques currently available for use by
procedural physicians (nonanesthetists) during medical or surgical
procedures such as those described above include sedatives and
opioids given orally, rectally or intra-muscularly; sedatives and
analgesics administered intravenously; and local anesthetics.
Often, however, such techniques are less than satisfactory.
[0006] In the case of oral, rectal or intra-muscular administration
of sedatives and opioids by procedural physicians during the
provision of conscious sedation, there are currently no effective
means available to assure that the effects of those drugs can be
readily controlled to meet patient need. This is due in part to the
variable interval between administration and the onset and
dissipation of drug effect. Unreliable sedation and analgesia can
result because of mismatches between the dosage administered and
the patient's needs which can vary depending on the condition of
the patient and the type of procedure performed. Such
administration of sedation can also produce an unconscious patient
at risk for developing airway obstruction, emesis with pulmonary
aspiration or cardiovascular instability. To attempt to avoid these
complications, procedural physicians often administer sedatives and
analgesics sparingly. This may reduce the risk of major
complications, but may also mean that few patients receive adequate
relief from pain and/or anxiety during medical and surgical
procedures outside the practice of anesthesiology.
[0007] The use of intravenous administration of sedatives and
analgesics to conscious patients by procedural physicians in
settings such as hospital laboratories, physicians' offices and
other ambulatory settings is also less than satisfactory. With
respect to intravenous bolus administration, plasma concentrations
vary considerably when drugs are injected directly into the blood
stream. This can result in initially excessive (potentially toxic)
levels followed by sub-therapeutic concentrations. Although
intravenously administered drugs can be titrated to the patient's
need, doing so safely and effectively usually requires the
full-time attention of a trained care giver, e.g., an
anesthesiologist. Costs and scheduling difficulties among other
things typically preclude this option.
[0008] Due to the difficulties described above involving
administration of sedatives and opioids, many procedural physicians
rely on local anesthetics for pain relief. However, local
anesthetics alone usually provide inadequate analgesia
(insensitivity to pain) for most medical and surgical procedures
and the injections themselves are often relatively painful.
[0009] In short, current methods commonly available to procedural
physicians for providing effective pain relief to conscious
patients outside the practice of anesthesiology typically fall
short of the objective. Moreover, there are currently no clear
standards of practice for nonanesthetists to guide the relief of
pain and anxiety for conscious patients. There is not adequate
training for such practitioners in the diagnosis and treatment of
complications that may arise or result from the provision of
sedation and analgesia to conscious patients. Procedures or
mechanisms for ongoing quality management of the care of conscious
patients undergoing painful and anxiety-inspiring medical or
surgical procedures and the devices and methods employed in that
care are inadequate.
[0010] An additional focus of this invention is the electronic
monitoring of a conscious patient's physiological condition during
drug delivery, and the electronic management of drug delivery by
conservative decision-making software that integrates and
correlates drug delivery with electronic feedback values
representing the patient's physiological condition, thereby
ensuring safe, cost-effective, optimized care. Significantly, in
many cases involving conscious sedation, the patient's
physiological condition is inadequately monitored or not
electronically monitored at all during drug delivery and recovery
therefrom. That is, there is often no electronic monitoring of
basic patient vital signs such as blood pressure, blood oxygen
saturation (oximetry) or of carbon dioxide levels in a patient's
inhaled and exhaled gases (capnometry). For example, patients
undergoing painful procedures in dentists' offices may receive
nitrous oxide (N.sub.2O) gas to relieve pain, but that drug
delivery is often not accompanied by electronic monitoring of a
patient's physiological condition, and currently there are no
devices available to nonanesthetists which safely and effectively
integrate electronic patient monitoring with such drug delivery
mechanisms.
[0011] In other circumstances involving the provision of conscious
sedation and analgesia by the procedural physician, such as a
cardiologist's performing a catheterization procedure in a hospital
laboratory, electronic patient monitors are sometimes used, but
again, there are no devices currently available to the
nonanesthetist which safely and effectively integrate both
mechanically (through close, physical proximity and incorporation
into a structural system), and electronically (through conservative
software management), electronic patient monitors with mechanisms
for drug delivery.
[0012] One aspect of the invention of this application is directed
to the simplification of drug delivery machines for relieving
patient pain and anxiety by eliminating features of those machines
that complicate the provision of patient pain and anxiety relief,
and by including those features that enable nonanesthetists to
provide safe, cost-effective, optimized conscious sedation and
analgesia. More specifically, current anesthesia machines used by
anesthesiologists to provide general anesthesia and a form of
conscious sedation administered by the anesthesiologist known as
"monitored anesthesia care" (MAC) include various complex features
such as oxygen (O.sub.2) flush valves which are capable of
providing large amounts of oxygen to the patient at excessive
pressures, and carbon dioxide (CO.sub.2) absorbent material which
absorbs CO.sub.2 from a patient's exhaled gases. In addition,
anesthesia machines typically deliver halogenated anesthetic gases
which can trigger malignant hyperthermia. Malignant hyperthermia is
a rare, but highly critical condition requiring the advanced
training and skills of an anesthesiologist for rapid diagnosis and
therapy. The airway circuit in current anesthesia machines is
circular in nature and self-contained in that the patient inhales
an oxygen/anesthetic gas mixture, exhales that mixture which is
then passed through CO.sub.2 absorbent material, re-inhales the
filtered gas mixture (supplemented by additional anesthetic and
oxygen), and repeats the process.
[0013] These aspects of anesthesia machines, among others, carry
attendant risks for the patient such that anesthesia machines
require operation by a professional trained through a multi-year
apprenticeship (e.g., an anesthesiologist or C.R.N.A.) in detecting
and correcting failure modes in the technology. For example, an
oxygen flush valve can cause oxygen to enter a patient's stomach
thereby causing vomiting; and carbon dioxide absorbent material can
fail in which case the patient could receive too much carbon
dioxide if the failure was not promptly detected and corrected.
Moreover, the use of the self-contained, circular airway circuit
could result in a circumstance whereby if the supply of O.sub.2
suddenly ceased, a patient would only be breathing the finite
supply of oxygen with no provision for administration of additional
requirements for O.sub.2 or atmospheric air. Such features, among
others, make anesthesia machines unusable by nonanesthetists.
Therefore, a focal point of this aspect of the invention is the
simplification of a drug delivery apparatus by selecting and
incorporating the appropriate features to facilitate the rendition
of safe and effective conscious sedation by nonanesthetists.
[0014] Certain aspects of this invention also focus on ensuring
maintenance of patient consciousness to prevent airway
difficulties, including monitoring the level of patient
consciousness during the delivery of one or more sedative,
analgesic and/or amnestic drugs to a conscious, non-intubated, and
spontaneously-ventilating patient to prevent airway difficulties.
For patients not intubated on a ventilator, monitoring the level of
patient consciousness is important to provide information about the
likelihood of depressed airway reflexes and respiratory drive to
breathe, the ability to maintain a patent airway, and the
likelihood of cardiovascular instability. Despite the importance of
monitoring and maintaining adequate levels of consciousness in
certain medical settings, there is no currently available device
for ensuring maintenance of patient consciousness by integrating
mechanically and electronically such monitoring of a patient's
level of consciousness with a drug delivery system. The invention
of this application is directed to this unmet need, as well.
[0015] This invention is also directed to providing conscious
patients relief from pain and/or anxiety in a manner that is
cost-effective and time efficient. Current solutions for relieving
patient pain and anxiety by drug delivery and electronic monitoring
of a patient's physiological condition are expensive and require a
great deal of time to set-up and take down. Also, the current
requirement or desire for the presence of an anesthesiologist
during some medical or surgical procedures increases costs,
especially if that desire requires in-patient care as opposed to
care in an ambulatory setting. To the extent medical procedures are
performed on conscious patients without adequate sedation and
analgesia due to the current unavailability of appropriate methods
and devices for providing such care (e.g., wound dressing changes
in burn wards), such procedures may need to be conducted on
numerous occasions, but over short periods of time (due to a
patient's inability to tolerate the level of pain), as opposed to
conducting a fewer number of more definitive procedures. The
requirement of multiple sessions of care also typically involves
increased costs. This invention addresses such cost-effectiveness
concerns and provides solutions to problems such as those
described.
[0016] The invention is further directed to the provision of relief
from post-operative or other post-procedural pain and discomfort in
remote medical care locations and home care type settings. Current
devices may permit certain patients in, for example, a home care
type setting, to provide themselves with an increased dosage of
analgesic through the use of a patient-controlled drug delivery
device, e.g., a device that permits a patient to press a button or
toggle a switch and receive more analgesic (often intravenously or
transdermally). This practice is sometimes called "PCA" or
patient-controlled analgesia. Known commercially available PCA-type
devices do not electronically integrate and conservatively manage
delivery of analgesics in accord with the electronic monitoring of
a patient's physiological condition. This invention focuses on this
unmet need, as well.
[0017] An additional aspect of this invention is directed to the
integration of a billing/information system for use with an
apparatus providing sedation, analgesia and/or amnesia to conscious
patients in physician's offices, hospital laboratory or other
ambulatory settings or remote medical care locations. Current
techniques for automated billing and invoice generating provide
inadequate and inefficient methods for tracking recurring revenues
derived from repeated use of medical devices such as the apparatus
of this invention.
[0018] Other focuses of the invention are apparent from the below
detailed description of preferred embodiments.
DESCRIPTION OF RELATED ART
[0019] Known machines or methods administered by the nonanesthetist
for providing conscious, non-intubated, spontaneously-ventilating
patients with sedation and analgesia are unreliable, not
cost-effective or are otherwise unsatisfactory. No commercially
available devices reliably provide such patients with safe and
cost-effective sedation, analgesia and amnesia to conscious
patients by integrating and correlating the delivery of sedative,
analgesic and/or amnestic drugs with electronic monitoring of a
patient's physiological condition. Available drug delivery systems
do not incorporate a safety set of defined data parameters so as to
permit drug delivery to be conservatively managed electronically in
correlation with the patient's physiological conditions, including
vital signs, to effectuate safe, cost-effective and optimized drug
delivery to a patient. Available drug delivery systems do not
incorporate alarm alerts that safely and reliably free the
nonanesthetist practitioner from continued concern of drug delivery
effects and dangers to permit the nonanesthetist to focus on the
intended medical examination and procedure. Moreover, there are no
known patient-controlled analgesia devices that mechanically and
electronically integrate and correlate (through conservative
software management) patient requests for adjustments to drug
dosage and electronic monitoring of patient physiological
conditions.
[0020] Known techniques have focused on the delivery of sedation
and analgesia to conscious patients with inadequate or no
electronic monitoring of patient physiological conditions,
including vital signs, and no electronic integration or correlation
of such patient monitoring with drug delivery. Other techniques
have focused on the provision of anesthesia to unconscious patients
with the requirement of an anesthesiologist to operate a
complicated, failure-intensive anesthesia machine.
[0021] Presently known nitrous oxide delivery systems such as those
manufactured by Matrx Medical, Inc., Accutron, Inc., and others are
used primarily in dental offices for providing conscious sedation
only. Such devices contain sources of nitrous oxide and oxygen, a
gas mixing device and system monitors, but no mechanical or
electrical integration of patient physiological condition monitors
with drug delivery mechanisms. Similarly, other known drug delivery
systems (e.g., intravenous infusion or intramuscular delivery
mechanisms) for providing sedatives and analgesics to conscious
patients used, for example, in hospital laboratories, do not
include mechanical or electronic integration of patient
physiological condition monitors with drug delivery mechanisms.
[0022] Anesthesia machines used by anesthesiologists to provide
general anesthesia or MAC, such as, by way of example, the NARKOMED
line of machines manufactured by North American Drager and EXCEL SE
ANESTHESIA SYSTEMS manufactured by Ohmeda Inc., mechanically
integrate electronic patient monitors in physical proximity to drug
delivery mechanisms. These machines, however, employ features such
as O.sub.2 flush valves, malignant hyperthermia triggering agents,
CO.sub.2 absorbent material, as well as circular airway circuits,
among others, thereby requiring operation by an M.D.A. (or
C.R.N.A.) to avoid the occurrence of life-threatening incidents.
These devices do not provide for the electronic integration or
management of drug delivery in correlation with the monitoring of a
patient's physiological condition, much less such electronic
management through conservative, decision-making software or logic
incorporating established safe data-defining parameters.
[0023] U.S. Pat. No. 2,888,922 (Bellville) discloses a
servo-controlled drug delivery device for automatic and continuous
maintenance of the level of unconsciousness in a patient based on
voltages representative of the patient's cortical activity obtained
by means of an electroencephalograph (EEG). The device continuously
and automatically increases or decreases in robotic fashion the
flow of anesthetic gas (or I.V. infusion) in response to selected
frequencies of brain potential to maintain a constant level of
unconsciousness.
[0024] U.S. Pat. No. 4,681,121 (Kobal) discloses a device for
measuring a patient's sensitivity to pain during the provision of
anesthesia, by applying a continuous, painful stimulus to the nasal
mucosa and regulating the level of anesthesia in response to EEG
signals indicating the patient's response to the nasal pain
stimulus, with the goal of maintaining a sufficient level of
unconsciousness.
[0025] Among other things, none of the above-described known
devices manages drug delivery to conscious patients employing
conservative decision-making software or logic which correlates the
drug delivery to electronic patient feedback signals and an
established set of safety data parameters.
SUMMARY OF THE INVENTION
[0026] The invention provides apparatuses and methods to safely and
effectively deliver a sedative, analgesic, amnestic or other
pharmaceutical agent (drug) to a conscious, non-intubated,
spontaneously-ventilating patient. The invention is directed to
apparatuses and methods for alleviating a patient's pain and
anxiety before and/or during a medical or surgical procedure and
for alleviating a patient's post-operative or other post-procedural
pain or discomfort while simultaneously enabling a physician to
safely control or manage such pain and/or anxiety. The costs and
time loss often associated with traditional operating room settings
or other requirements or desires for the presence of anesthetists
may thus be avoided.
[0027] A care system in accordance with the invention includes at
least one patient health monitor which monitors a patient's
physiological condition integrated with a drug delivery controller
supplying an analgesic or other drug to the patient. A
programmable, microprocessor-based electronic controller compares
the electronic feedback signals generated from the patient health
monitor and representing the patient's actual physiological
condition with a stored safety data set reflecting safe and
undesirable parameters of at least one patient physiological
condition and manages the application or delivery of the drug to
the patient in accord with that comparison. In a preferred
embodiment, the management of drug delivery is effected by the
electronic controller via conservative, decision-making software
accessing the stored safety data set.
[0028] In another aspect the invention also includes at least one
system state monitor which monitors at least one operating
condition of the care system, the system state monitor being
integrated with a drug delivery controller supplying drugs to the
patient. In this aspect, an electronic controller receives
instruction signals generated from the system monitor and
conservatively controls (i.e., curtails or ceases) drug delivery in
response thereto. In a preferred embodiment, this is accomplished
through software control of the electronic controller whereby the
software accesses a stored data set reflecting safe and undesirable
parameters of at least one operating condition of the care system,
effects a comparison of the signal generated by the system state
monitor with the stored data set of parameters and controls drug
delivery in accord with same, curtailing or ceasing drug delivery
if the monitored system state is outside of a safe range. The
electronic controller may also activate attention-commanding
devices such as visual or audible alarms in response to the signal
generated by the system state monitor to alert the physician to any
abnormal or unsafe operating state of the care system
apparatus.
[0029] The invention is further directed to an apparatus which
includes a drug delivery controller, which delivers drugs to the
patient, electronically integrated with an automated consciousness
monitoring system which ensures the consciousness of the patient
and generates signal values reflecting patient consciousness. An
electronic controller is also included which is interconnected to
the drug delivery controller and the automated consciousness
monitor and manages the delivery of the drugs in accord with the
signal values reflecting patient consciousness.
[0030] In another aspect, the invention includes one or more
patient health monitors such as a pulse oximeter or capnometer and
an automated consciousness monitoring system, wherein the patient
health monitors and consciousness monitoring system are integrated
with a drug delivery controller supplying an analgesic or other
drug to the patient. A microprocessor-based electronic controller
compares electronic feedback signals representing the patient's
actual physiological condition including level of consciousness,
with a stored safety data set of parameters reflecting patient
physiological conditions (including consciousness level), and
manages the delivery of the drug in accord with that comparison
while ensuring the patient's consciousness. In additional aspects
of the invention the automated consciousness monitoring system
includes a patient stimulus or query device and a patient initiate
response device.
[0031] The invention also provides apparatuses and methods for
alleviating post-operative or other post-procedural pain or
discomfort in a home care-type setting or remote medical care
location. Here the care system includes at least one patient health
monitor integrated with patient-controlled drug delivery. An
electronic controller manages the patient-controlled drug delivery
in accord with electronic feedback signals from the patient health
monitors. In a preferred embodiment the electronic controller is
responsive to software effecting conservative management of drug
delivery in accord with a stored safety data set.
DESCRIPTION OF THE DRAWINGS
[0032] Other objects and many of the intended advantages of the
invention will be readily appreciated as they become better
understood by reference to the following detailed description of
preferred embodiments of the invention considered in connection
with the accompanying drawings, wherein:
[0033] FIG. 1 is a perspective view of a preferred embodiment of a
care system apparatus constructed in accordance with this
invention, depicting the provision of sedation, analgesia and/or
amnesia to a conscious patient by a nonanesthetist.
[0034] FIG. 2 is a perspective view of a preferred embodiment of a
care system apparatus constructed in accordance with this invention
depicting user interface and patient interface devices.
[0035] FIGS. 3A and 3B are side-elevational views of a preferred
embodiment of an apparatus constructed in accordance with this
invention.
[0036] FIG. 4A is a block diagram overview of the invention.
[0037] FIG. 4B is an overview data-flow diagram depicting the drug
delivery management aspect of the invention.
[0038] FIG. 5 depicts a preferred embodiment of the invention.
[0039] FIG. 6 depicts a preferred embodiment of a drug delivery
system in accordance with the invention.
[0040] FIGS. 7A-7C depict the details of a preferred embodiment of
the drug source system in accordance with the invention.
[0041] FIG. 8 depicts a preferred embodiment of an electronic mixer
system in accordance with the invention.
[0042] FIG. 9A depicts one embodiment of a manifold system in
accordance with the invention.
[0043] FIG. 9B depicts a second embodiment of a manifold system in
accordance with the invention.
[0044] FIG. 10A depicts a preferred embodiment of a manual bypass
system in accordance with the invention.
[0045] FIG. 10B depicts a preferred embodiment of a scavenger
system in accordance with the invention.
[0046] FIG. 11 depicts a preferred embodiment of a patient
interface system in accordance with the invention.
[0047] FIGS. 12A and 12B are a front perspective view and a
side-elevational view, respectively, of a preferred embodiment of
hand cradle device constructed in accordance with the
invention.
[0048] FIGS. 13A and 13B are rear perspective views of a preferred
embodiment of hand cradle device constructed in accordance with the
invention.
[0049] FIGS. 14A and 14B are, respectively, a front perspective
view of an alternative embodiment of a hand cradle device
constructed in accordance with this invention and a top plan view
of a patient drug dosage request device in accordance with the
invention.
[0050] FIG. 15 shows a perspective view of a preferred embodiment
of the invention, including a hand cradle device and an ear piece
combination oximeter/auditory query device.
[0051] FIG. 16 is a side-elevational view of an ear piece placed
within a patient's ear containing a pulse oximetry sensor and an
auditory query in accordance with the present invention.
[0052] FIG. 17 depicts an alternative preferred embodiment of a
care system apparatus constructed in accordance with the
invention.
[0053] FIG. 18 depicts a user interface system in accordance with a
preferred embodiment of the invention.
[0054] FIGS. 19A and 19B depict the various peripheral devices
included in a preferred embodiment of the invention.
[0055] FIG. 20 depicts a preferred embodiment of a patient
information/billing system in accordance with the invention.
[0056] FIG. 21A depicts examples of drug delivery management
protocols for 3-stage alarm states reflecting monitored patient
parameters in accordance with the invention.
[0057] FIG. 21B depicts examples of drug delivery management
protocols for 2-stage alarm states reflecting monitored system
state parameters in accordance with the invention.
[0058] FIG. 22A depicts a first embodiment of a user interface
screen display in accordance with the invention.
[0059] FIG. 22B depicts a second embodiment of a user interface
screen display in accordance with the invention.
[0060] FIG. 23A is a data-flow diagram depicting an example of the
steps performed by the drug delivery management software or logic
responsive to patient health monitors in accordance with the
invention.
[0061] FIG. 23B is a data-flow diagram depicting an example of the
steps performed by the drug delivery management software or logic
responsive to system state monitors in accordance with the
invention.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0062] The embodiments illustrated below are not intended to be
exhaustive or to limit the invention to the precise forms
disclosed. The embodiments are chosen and described in order to
explain the principles of the invention and its applications and
uses, and thereby enable others skilled in the art to make and
utilize the invention.
[0063] FIG. 1 shows a care system 10 constructed in accordance with
this invention, providing sedative, analgesic and/or amnestic drugs
to a conscious, non-intubated, spontaneously-ventilating patient
undergoing a medical or surgical procedure by a procedural
physician. The system 10 has a generally columnar housing 15 with
various storage compartments 16 therein for storage of user and
patient interface devices, and a base 17 supported on castor wheels
18. A drug delivery system 40 delivers a mixture of one or more
gaseous sedative, analgesic or amnestic drugs in combination with
oxygen (O.sub.2) gas to a patient, and includes a one-way airway
circuit 20 connected at one end to a face mask 30 and at the other
end to a manifold valving system contained within housing 15. FIGS.
3A and 3B show from a side-elevation perspective, airway circuit
20, face mask 30, and exhaust hose 32 through which scavenged
patient exhaled gases are exhausted to a safe location.
[0064] Referring to FIG. 2, lead 50 connects one or more patient
interface devices (e.g., 55) to a microprocessor-based electronic
controller or computer (sometimes also referred to herein as main
logic board, MLB) located within housing 15. The electronic
controller or main logic board may be comprised of combinations of
available programmable-type microprocessors and other "chips,"
memory devices and logic devices on various board(s) such as those
manufactured by Texas Instruments (e.g., XK21E) and National
Semiconductor (e.g., HKL 72, among others. Patient interface
devices 55 can include one or more patient health monitors that
monitor a patient's physiological condition, such as known pulse
oximeter, capnometer (not shown), non-invasive blood pressure
monitors; EKG, EEG, acoustical monitors (not shown), and others; an
automated consciousness monitoring system, including query initiate
and response devices in accordance with the invention (described
below); and patient drug dosage request devices (also described
below). The main logic board electronically manages operation of
the apparatus 10 by means of conservative, decision-making software
that integrates and correlates patient feedback signals received
from the one or more patient health monitors with drug
delivery.
[0065] Also shown in FIGS. 1 and 2 are various user interface
devices, including a display device 35 integrated into the top
surface of apparatus 10 which displays patient and system
parameters and operation status of the apparatus, a printer 37
which prints, for example, a hard copy of patient parameters
indicating the patient's physiological condition and the status of
various system alarms with time stamps, and a remote control device
45 which permits a physician to interact with apparatus 10. The
various patient and user interface devices are described in more
detail below.
[0066] It should be recognized that although certain embodiments of
the invention show the analgesic delivery system 40 in a form for
delivering one or more sedative, analgesic or amnestic drugs in
gaseous form, the invention also specifically includes embodiments
where such drugs are delivered intravenously, in nebulized,
vaporized or other inhaled form, and/or transdermally such as by
using known ion-transfer principles. Drugs that may be delivered by
the care system include, but are not limited to, nitrous oxide,
propofol, remifentanil, dexmedetamidine, epibatadine and
sevoflurane. Alternative embodiments are described in more detail
herein.
[0067] FIG. 4A is a block diagram overview of a preferred
embodiment of the invention. FIG. 4B is an overview data flow
diagram depicting the drug delivery management steps performed by
the software/logic control of microprocessor controller 14 in a
preferred embodiment of the invention. In FIG. 4A, one or more
patient health monitors 12a (which may include one or more known
patient physiological condition monitors such as pulse oximeters,
capnometers, other ventilatory monitors, non-invasive blood
pressure monitors, EKG, EEG and others, as well as a patient
consciousness monitoring system) are electronically coupled,
through suitable A-D converters where appropriate, to electronic
controller 14, described above. Patient health monitors 12a
generate electronic feedback signals representing actual patient
physiological data which are converted to electronic signals and
then provided to controller 14. Now referring to FIG. 4B,
electronic controller 14, e.g., through appropriate software and/or
logic, compares the received electronic patient feedback signals
13b with the safety data set 15b stored in a memory device (such as
an EPROM device). The stored safety data set 14a (FIG. 4A) contains
at least one set of data parameters representing safe and
undesirable patient physiological conditions. Based on the
comparison of the actual monitored patient physiological data 13b
with the safety data set 14a, controller 14 determines whether the
monitored patient physiological data is outside of a safe range
(FIG. 4B, 16b). If the monitored patient data is outside of a safe
range, electronic controller 14 sends instruction commands
(signals) to drug delivery controller 2a (FIG. 4A) instructing drug
delivery controller 2a to conservatively manage (e.g., reduce or
cease) drug delivery (FIG. 4B, 18b). Drug delivery controller 2a
may be a standard solenoid valve-type electronic flow controller
known to those skilled in the art.
[0068] As is described below, additional embodiments of the
invention also contemplate provision of electronic feedback signals
representing patient-controlled drug dosage increase or decrease
requests to controller 14 and electronic management of drug
delivery in consideration of such patient requests vis-a-vis the
patient's physiological parameters and/or the state of the care
system.
[0069] A block diagram of a preferred embodiment of a care system
in accordance with the invention is depicted in FIG. 5. Analgesic
delivery system 2 of FIG. 5 delivers a mixture of gaseous sedative,
analgesic and/or amnestic drugs (such as nitrous oxide, sevoflurane
or nebulized narcotics) and oxygen gas to the patient. Manual
bypass circuit 4 (shown in further detail in FIG. 6 and FIG. 10A)
is coupled to the manifold system portion of analgesic delivery
system 2 and bypasses the source of analgesia enabling the manual
control of delivery of atmospheric air to the patient. An auxiliary
inlet 6 is provided to analgesic delivery system 2 and enables the
provision of in-house supply of gaseous drug or oxygen to the
delivery system 2. Scavenger system 8 (shown in detail in FIG. 10B)
is coupled to analgesic delivery system 2 and collects exhaled
gases from the patient and exhausts them to a safe location through
exhaust hose 32 (FIG. 3B).
[0070] Patient interface system 12 includes one or more patient
health monitors (these can be known vital sign monitors, such as
non-invasive blood pressure monitors, or known pulse oximeters,
capnometers, EKGs, etc.); means for monitoring the level of a
patient's consciousness; and/or means for the patient to
communicate with system 10 (FIG. 1), such as by requesting an
increase or decrease in the dosage of drugs. One or more of these
patient monitoring and request devices are electronically coupled
to and, through A-D converters, provide feedback signals
representing the patient's actual physiological condition and drug
dosage requests to electronic controller 14. Controller 14 compares
this electronic feedback received with data stored in a memory
device, said data representing sets of one or more safe and
undesirable patient physiological condition parameters (e.g., safe
and undesirable O.sub.2 saturation conditions, end tidal CO.sub.2
levels and/or levels of patient consciousness). These sets of
parameters are collectively referred to as a safety data set. Based
on the comparison, controller 14 commands conservative application
of drug delivery in accord with said parameters at safe,
cost-effective optimized values.
[0071] Still referring to FIG. 5, user interface system 16
(described in more detail in FIGS. 18 and 22) displays electronic
signal values stored in or provided to electronic controller 14,
such values reflecting the status of one or more of the patient's
physiological state, the patient's level of consciousness, and/or
the status of various care system parameters. User interface system
16 includes devices that permit the nonanesthetist to interact with
the care system via controller 14 (e.g., input patient information,
pre-set drug dosages, silence alarms) such as keyboard 230 (FIG. 2)
and/or remote control unit 45 (FIG. 1). Patient and care system
information is displayed by means of graphical and numeric display
devices, e.g., 35 (FIG. 1), LEDs incorporated into housing 15 (FIG.
1) and/or on remote control unit 45.
[0072] External communication devices 18 (also described in FIGS.
19A and 19B) enable the sending and/or receiving of electronic
information signals to and from electronic controller 14 and
external computers at remote locations or on local networks.
Peripheral devices 22 such as door and temperature sensors, among
others, communicate electronically with controller 14 to ensure the
proper, safe and secure operation of care system 10.
[0073] The above systems overviewed in FIG. 5 are now described in
more detail.
[0074] FIG. 6 shows in further detail an overview of a preferred
drug delivery system 2 (FIG. 5) which provides a mixture of one or
more sedative, analgesic and/or amnestic drugs in gaseous form;
oxygen; and atmospheric air to a patient, the provision of each
being independently adjustable (manually and via electronic
controller 14) by the physician. The drug delivery system is
comprised of a drug source system 42, an electronic mixer system 44
and a manifold system 46.
[0075] Drug source system 42 contains sources of one or more
gaseous drugs and oxygen and is coupled through pneumatic lines to
electronic mixer system 44. Drug source system 42 is also
electronically coupled to electronic controller 14, and as is
described below, contains sensors monitoring one or more operating
states of drug source system 42 (e.g., whether the drug is
flowing). Such monitored system information is converted to
appropriate electronic signals and fed back to electronic
controller 14 via the electronic coupling.
[0076] Electronic mixer 44 receives the one or more gaseous drugs,
O.sub.2 and atmospheric air through the pneumatic lines and
electronically mixes same. Electronic mixer 44 is also
electronically coupled to electronic controller 14 and also
contains sensors that provide electronic feedback signals
reflecting system operation parameters of mixer 44 to electronic
controller 14. Mixer 44 includes electronic flow controllers with
solenoid valves which receive flow control instruction signals from
controller 14.
[0077] Manifold system 46 is coupled through pneumatic lines to and
receives the one or more gaseous drugs, O.sub.2 and air mixture
from electronic mixer 44 and delivers the mixture to the patient
via airway circuit 20 (FIG. 1) and face mask 30 (FIG. 1). Manifold
system 46 is also electronically coupled to electronic controller
14 and includes sensors that provide electronic feedback signals
reflecting manifold system 46 operation parameters to controller
14. Manifold 46 delivers patient exhaled gases to a scavenging
system 48 for exhaust to a safe location via exhaust hose 32 (FIG.
3B).
[0078] Drug source system 42 is shown in further detail in FIGS.
7A-7C. Referring to FIG. 7A, analgesic source system includes drug
source system 142 which provides a source of one or more sedative,
analgesic and/or amnestic drugs; and an oxygen source system 144
which provides a source of oxygen. In aspects of this invention
where the drugs are in gaseous form, the sources of drugs and
oxygen provide the gases at low pressure, and can be tanks
contained within housing 15 (FIG. 1) such as those shown at numeral
54 in FIG. 2 or an in-house source. The ability to use alternative
sources increases the useability of the care system of the
invention because the system can function as a source-dependent
unit within rooms with access to in-house gas supplies or as a
self-contained unit within rooms that do not have in-house gas
connections.
[0079] In additional aspects of the invention, drug source system
42 can include one or more of the following: known nebulizers 143
which enable the delivery of aerosolized drugs, such as morphine,
meperidine, fentanyl and others; known vaporizers 145 which enable
the delivery of halogenated agents, such as sevoflurane; known
infusion pump-type drug delivery devices 147 or known
transdermal-type drug delivery devices 149 (including ion transfer
based devices) to enable the delivery of drugs such as propofol,
remifentanil, and other infusible drugs by continuous or bolus
administration.
[0080] FIG. 7B details the oxygen source system and shows an oxygen
tank or other source of oxygen 104 and a pneumatic oxygen line 109
for delivering oxygen gas to electronic mixer system 44 (FIG. 7A).
Filter 106a in oxygen line 109 removes contaminants within the
oxygen stream from oxygen source 104. Pressure sensor 106 (which
may be of a type known and currently available) in oxygen line 109
monitors the pressure in oxygen source 104 generating a signal
reflecting same and thereby indirectly measuring the amount of
oxygen remaining. Pressure sensor 106 is electronically coupled to
electronic controller 14 and forwards signals reflecting the
measure of pressure in the oxygen source to controller 14. In a
preferred embodiment, electronic controller 14 receives the signal
from pressure sensor 106 and through software accesses data
parameters stored in a memory device. The parameters reflect one or
more setpoints establishing safe and undesirable operating
conditions of O.sub.2 operating pressure. Controller 14 compares
the actual O.sub.2 pressure to the stored parameter set point data.
If the comparison reveals that the O.sub.2 pressure is outside of
an established safe range as established by the stored data, an
alarm or other attention-commanding device activates and if same is
not manually deactivated, electronic controller 14 instructs the
flow of drug delivery to reduce to a pre-set safe amount (or
cease). The operation of the software control vis-a-vis system
state monitors is described in more detail in connection with FIGS.
21A and 23A.
[0081] The signal obtained from oxygen source pressure sensor 106
can be related to the user via display devices (e.g., 35, FIG. 2)
in terms of the time remaining under present use so that the user
can ascertain if the procedure can be completed. The user is
immediately notified if the pressure falls out of the normal
operating conditions by an alarm, display device or other suitable
attention-commanding device. Pressure gauges 108 visually display
to the user the oxygen source pressure obtained by sensor 106.
Pressure regulator 110, which may be of a known solenoid type
currently available or other suitable regulator, enables the
reduction of pressure in oxygen source 104 to a reasonable
operating pressure to provide flow of O.sub.2 to the patient. Check
valve 112 (check valves may be of a standard one-way type), in
oxygen line 109 downstream of regulator 110 prohibits backward flow
of the patient's exhalations and ensures that such back-flow does
not damage or contaminate regulator 110 and oxygen source 104. In
systems where an in-house oxygen source 105 is used, remote check
valve 114 ensures that back-flow from the patient's exhalations
does not damage or contaminate in-house oxygen source 105. Pressure
relief valve 116 exhausts oxygen to the atmosphere if the pressure
in oxygen line 109 exceeds safe operating values pre-programmed
into electronic controller 14.
[0082] FIG. 7C details the drug source system and in a preferred
embodiment includes a tank or other source of drug 204 and a
pneumatic line 209 for delivering gaseous drugs to electronic mixer
44. Filter 206a in drug line 209 removes contaminants within the
drug stream from drug source 204. Pressure sensor 206 (which may be
of a type known and currently available) in drug line 209 monitors
the pressure in drug source 204 generating a signal reflecting same
and thereby indirectly measuring the amount of drug. Pressure
sensor 206 is electronically coupled to electronic controller 14
and forwards signals reflecting the measure of pressure in the drug
source to controller 14. As is described above in connection with
oxygen source pressure sensor 106 and in FIGS. 21A and 23A, in a
preferred embodiment controller 14 receives the signal from sensor
206 and through software accesses stored data parameters reflecting
safe and undesirable operating conditions of drug source pressure
and conservatively controls drug delivery in accord with said
stored parameters.
[0083] The signal obtained from the drug source pressure sensor 206
can be related to the user via display devices (e.g., 35, FIG. 2)
in terms of the time remaining under present use so that the user
can ascertain if the procedure can be completed. The user is
immediately notified via an alarm, display device or other suitable
attention-commanding device if the pressure falls out of the normal
operating conditions. Pressure gauges 208 visually display to the
user the drug source pressure obtained by sensor 206. Pressure
regulator 210, which may be of a known solenoid type currently
available, enables the reduction of pressure in drug source 204 to
a reasonable operating pressure to provide flow of drug to the
patient. Check valve 212 in drug line 209 downstream of regulator
210 prohibits backward flow of the patient's exhalations and
ensures that back-flow from the patient's exhalations does not
damage or contaminate regulator 210 and drug source 204. In systems
where an in-house drug source 205 is used, remote check valve 214
ensures that back-flow from the patient's exhalations does not
damage or contaminate in-house drug source 205. Pressure relief
valve 216 exhausts the drug to the atmosphere if the pressure in
drug line 209 exceeds safe operating values pre-programmed into
electronic controller 14.
[0084] To increase safety, the known pin indexed safety system
(P.I.S.S.) and/or diameter indexed safety system (D.I.S.S.) may be
used for all O.sub.2 source and line fittings where appropriate for
tank and/or in-house sources. This ensures, for example, that
oxygen source 104 is not mistakenly attached to the drug line 209
and vice versa.
[0085] FIG. 8 details a preferred electronic gas mixer system which
electronically mixes gaseous drugs and oxygen so that the precise
flow rate of gaseous drug and oxygen is delivered to the patient.
The use of the electronic mixer system of this invention increases
the operational safety of the apparatus of the invention because,
as described below, the volume of drug delivery can be
electronically controlled in closed-loop fashion by currently
available electronic flow controllers which include solenoid type
valves which, in response to command signals from electronic
controller 14, halt or reduce the flow of drugs to the patient in
the event of an occurrence of unsafe patient or system conditions.
Specifically, pneumatic oxygen line 109 and drug line 209 from
analgesic source system 42 deliver gaseous drugs and oxygen to
filters 125 and 127 in lines 109 and 209, respectively, which
filter contaminants from lines 109 and 209. System state monitors,
namely, pressure sensors 129, 131, monitor the oxygen and gaseous
drug line pressures, respectively, and transmit signals reflecting
said pressures to electronic controller 14, which conservatively
controls drug delivery in accord with a stored data set containing
parameters reflecting one or more safe and undesirable system
operation states as described above and in FIGS. 21A. and 23A.
Also, if any of the pressures fall out of the norm, electronic
controller 14 immediately alerts the user, for example, by means of
signaling an alarm device.
[0086] Electronic flow controllers 133, 135, which may be of a
known type currently available including solenoid valves, are
electronically coupled to and receive instruction signals from
electronic controller 14 which has been programmed with and/or
calculates a desired flow rate of oxygen and drug. Programmed flow
rates may be those input by the physician user employing
traditional choices regarding drug administration amounts and
rates, including in IV embodiments, target controlled infusion
principles, among others. Calculated flow rates may be arrived at
through conservative decision-making software protocols including
comparison of actual patient physiological condition feedback
values with stored data representing safe and undesirable patient
physiological conditions. Drug delivery is affected at the rates
calculated in a closed, control-loop fashion (described in more
detail below) by flow controllers 133, 135. Drug administration may
be a combination of one or more physician inputs and/or electronic
flow rate calculations based on patient and system state
parameters; flow controllers may respond to instruction signals
initiated by electronic controller 14 or by the physician.
[0087] Flow controllers 133, 135 receive instruction signals from
controller 14 reflecting the electronic output of both system state
monitors (such as pressure sensors 106, 206 described above) and
patient state monitors. Flow controllers 133, 135, in response to
instruction signals from controller 14, may curtail or cease flow
of drug delivery when system state and/or patient health monitors
indicate to controller 14 that failures in the operation of care
system 10 have occurred, that system 10 is otherwise operating
outside of an established safe state, or that a patient's
physiological state (e.g., vital signs or consciousness level) has
deteriorated to an unsafe condition.
[0088] As the invention includes both intravenous and gaseous,
among other forms of drug delivery, such embodiments may also
include known electronic flow controllers coupled to electronic
controller 14 and responsive to instruction signals from controller
14 reflecting both patient and system states.
[0089] Referring again to FIG. 8, solenoid valve 132 is
electronically coupled to electronic controller 14 and must be
activated by same before drug will flow through line 209. In the
event of system power failure, drug delivery will be halted due to
the fail-closed nature of solenoid valve 132. This is described,
for example, in FIG. 21A which shows that if a system state monitor
indicates power failure, alarm type "2" sounds to alert the
nonanesthetist and drug delivery is halted (i.e., reduced to
0%).
[0090] Moreover, pressure actuated valve 134 in drug line 209
responds to the amount of pressure in O.sub.2 line 109 and permits
flow of gaseous drug only if sufficient oxygen flows through oxygen
line 109. Check valve 136a in drug line 209 ensures that the flow
of gaseous drug to manifold system 46 is one-way and that there is
no back-flow. Check valve 136b in oxygen line 109 ensures one-way
flow of O.sub.2 to manifold system 46 with no back-flow.
[0091] In atmospheric air line 139, air inlet solenoid valve 137 is
electronically coupled to and activated by electronic controller 14
and if activated permits atmospheric air to be mixed with the
oxygen gas by means of air ejector 138. Air ejector 138 injects a
fixed ratio of atmospheric air into oxygen line 109. Filter 128
removes contaminants from air line 139 and check valve 136c ensures
one-way flow of air from solenoid valve 137 to ejector 138 with no
back-flow.
[0092] Referring to FIG. 9A which details one embodiment of
manifold system 46 (FIG. 6), the drug/O.sub.2 gas mixture from
electronic mixer system 44 (FIG. 6) enters manifold system 46 and
flows into inspiratory plenum 150 from which it proceeds through
inspiratory line 151 to primary inspiratory valve (PIV) 152 and
eventually to airway circuit 20 and mask 30 (FIG. 1). Primary
inspiratory valve 152 permits one-way flow of said gas mixture and
ensures that exhaled gases from the patient do not enter the
inspiratory side of manifold system 46 (FIG. 6), thereby guarding
against possible contamination. Atmospheric air may be permitted to
enter inspiratory line 151 through an inspiratory negative pressure
relief valve (INPRV) 154 which allows one-way flow of atmospheric
air to reach the patient if a significant negative vacuum is drawn
on the inspiratory side of manifold system 46 (e.g., the patient
inhales and receives no or insufficient oxygen). INPRV 154 thereby
essentially permits air on demand by the patient. INPRV filter 153
removes particulates which may be in air line 155 or present in the
atmosphere. INPRV status sensor 156 (which may be of a known
pressure, temperature, infra-red or other suitable type) monitors
the extent of open/close status of INPRV 154 and generates a signal
which is converted to an appropriate electronic (digital) signal
and communicates the status of INPRV 154 to electronic controller
14. During the exhalation phase of the patient's breathing cycle,
inspiratory reservoir bag 149 collects the drug/O.sub.2/air mixture
which the patient will draw on the next inhalation phase.
[0093] Still referring to FIG. 9A, pressure sensor 166 measures
pressure in airway circuit 20 (FIG. 1) and is used to indicate
airway flow, i.e., if the primary inspiratory valve (PIV) 152 or
the primary expiratory valve (PEV) 168 is occluded. For example, if
sensor 166 reads a high pressure that indicates that PEV 168 is
blocked, whereas a low pressure indicates PIV 152 is blocked.
Airway circuit 20 (FIG. 1) also contains a fraction of inspired
oxygen (FIO.sub.2) sensor 167 (which may be of a known type
currently available) which measures the oxygen percentage of gas
contained in the mixture delivered to the patient, and thus guards
against the possibility of delivering a hypoxic mixture to the
patient (i.e., a drug/O.sub.2 mixture that does not provide enough
O.sub.2 to the patient). INPRV status sensor 156, pressure/airway
flow sensor 166, and FIO.sub.2 sensor 167 are electronically
coupled to and provide electronic feedback signals reflecting
system state parameters to electronic controller 14. As described
in FIGS. 21A and 23A, controller 14, through software and/or logic,
effects a comparison of the signals generated by these system
monitors with a stored data set of system parameters established by
setpoints and/or logic-type data reflecting safe and undesirable
system operating states, and conservatively controls (e.g., reduces
or halts) drug delivery if the comparison determines that care
system 10 is operating outside of a safe range.
[0094] Airway circuit and mask (20, FIG. 9) interface with the
patient to provide a closed circuit for the delivery of
drug/O.sub.2 gas mixture to the patient. It should be recognized
that embodiments of the subject invention in which the drugs are
delivered in a form other than compressed gas, such as
intravenously or transdermally, may not include face masks, airway
circuit features and other aspects associated with delivery of
drugs in gaseous form. Where the drug is delivered in gaseous form
and an airway circuit and face mask are employed, such face mask
and attendant airway circuitry and other features such as the
scavenging system may be in the form of that described in U.S. Pat.
No. 5,676,133 issued to Hickle et al. and entitled Expiratory
Scavenging Method and Apparatus and Oxygen Control System for
Post-Anesthesia Care Patients. (With respect to such embodiments,
the specification of Hickle et al. is incorporated herein by
reference.)
[0095] In preferred embodiments the mask is disposable and contains
means for sampling the CO.sub.2 content of the patient's
respiratory airstream and, optionally, means for also measuring the
flow of the patient's airstream and/or means for acoustical
monitoring. The sampling of the CO.sub.2 in the patient's airstream
may be done by means of a capnometer or a lumen mounted within the
mask through a port in the mask, and placed close to the patient's
airway. A second lumen similarly mounted within the mask could be
used to measure the airflow in the patient's airstream. This
airflow measurement could be accomplished by a variety of currently
available devices, including for example, devices that measure the
pressure drop in the airstream over a known resistance element and
thereby calculate the airflow by known formula. The means for
acoustical monitoring may be a lumen placed within the mask with a
microphone affixed within that lumen. The microphone would permit
recording, transducing and playing out through an amplifier the
audible sound of the patient's breathing. It is noted that the
lumen for acoustical monitoring could be a separate lumen or could
be combined with the lumen for calculating the flow of the
patient's airstream. It is further noted that it is important to
place the lumens, especially the CO.sub.2 sampling lumen, close to
the patient's open airway and to ensure such lumens remain close to
the patient's airway.
[0096] Referring again to FIG. 9A, primary expiratory valve (PEV)
168 in expiratory line 172 ensures one-way flow of a patient's
exhaled gases to scavenger pump system 48, thus, prohibiting any
back-flow from gases exhaled to the scavenger system from reaching
the patient. Importantly, PEV 168 guards against the re-breathing
of exhaled carbon dioxide. As is easily seen, the manifold 46 and
airway circuit 20 of a preferred embodiment of this invention
permit one-way airway flow only. That is, unlike prior devices that
employ circular airway circuits (which require CO.sub.2 absorbent
material to permit re-breathing of exhaled air), there is no
re-breathing of exhaled gases in this embodiment of the
invention.
[0097] In the embodiment of the invention shown in FIG. 9A,
expiratory positive pressure relief valve (EPPRV) 164 in expiratory
line 172 allows exhaled gases to escape to the atmosphere if
sufficient positive pressure develops on the expiratory side of the
manifold system. This could happen, for example, if the patient is
exhaling, but scavenger system 48 (FIG. 6) is occluded or otherwise
not working properly. EPPRV filter 175 downstream of EPPRV 164
filters contaminants from the expiratory stream flowing through
EPPRV 164 prior to the stream entering the atmosphere. Expiratory
negative pressure relief valve (ENPRV) 178 is a one-way valve that
allows atmospheric air to be drawn into expiratory plenum 180 and
then on to scavenger system 48 if sufficient vacuum pressure is
drawn on the expiratory side of manifold system 46. This could
happen, for example, if the vacuum pump of scavenger system 48 is
set too high or PEV 168 is blocked. Expiratory reservoir bag 177
collects exhaled gases from the patient during exhalation via
expiratory plenum 180. These gases will be exhausted by scavenger
system 48 during the next patient inhalation phase. As is described
in detail below, patient vital sign monitor, such as a capnometer
184, monitors the amount of CO.sub.2 in the patient's exhaled gases
and provides electronic feedback signals reflecting the level of
CO.sub.2 in the patient's exhalations to controller 14. Other types
of ventilatory monitors such as an airflow measure, IPG device or
an acoustical monitor could also be used to provide electronic
feedback signals reflecting patient health parameters to controller
14.
[0098] In an alternative preferred embodiment shown in FIG. 9B,
ENPRV 164, filter 175 and ENPRV 178 are eliminated. A long pipe or
similar conduit 175a, interconnected with reservoir bag 177 and
opening to atmospheric air, is substituted therefor. The
elimination of the valves 164 and 175 provides for a more cost
efficient and simple system, while the substituting of the pipe
175a still ensures that if the scavenger system 48 is occluded, is
set too high, is otherwise not working or if PEV 168 is blocked,
that there is still access to atmospheric air, and the patient may
breath into the room or air may come into the system. A highly
compliant reservoir bag 179 also assists in catching excess flow of
exhaled air. In this simplified embodiment, there are essentially
only three valves, PIV 152, PEV 168 and INPRV 154.
[0099] As is described above, system valves PIV 152 and PEV 168
ensure one-way flow of inspired and expired gases. The patient
cannot re-breathe exhaled gases and no contaminants are allowed to
enter the source system. The valve system INPRV 154, EPPRV 164, and
ENPRV 178 (or the alternate INPRV 154 and pipe) provides a system
fail-safe. If analgesic source system 42 (FIG. 6) or scavenging
system 48 (FIG. 6) is functioning improperly, the valves will open
and allow the patient to breathe without significant effort. The
system state sensors 156, 166 and 167 monitor system operation such
as INPRV valve status, gas pressure and fraction of inspired
oxygen, and electronically feedback signals reflecting the
operating status of those operations to microprocessor controller
14 to ensure safe operation of the apparatus.
[0100] It is noted that the valves and sensors between INPRV 154
and ENPRV 178 in a preferred embodiment of manifold system 46 can
be considered a system state monitoring system because there are no
valves controlled by the software of electronic controller 14. At
this point in the care system 10, the gas has already been mixed
and the volume determined by the flow controllers 133, 135 (FIG.
8). Manifold system 46 (FIG. 6) provides at least two basic
services, sensor inputs for FiO.sub.2 and CO.sub.2 (167, 184 of
FIG. 9) and flow status derived from flow sensor 166 (FIG. 9).
[0101] The determination of appropriate drug delivery/flow
percentages by controller 14 can be accomplished through a variety
of methods. Initial drug administration amounts and rates may be
selected and input by the physician employing traditional methods.
Physicians may also employ pharmacokinetic/pharmacodynamic modeling
to predict resulting drug concentrations and their effect based on
physician choices, but not permit automatic changes to drug
concentrations without instructions from the physician. In
intravenous embodiments known target-controlled infusion techniques
may be employed where the physician selects a desired (targeted)
blood serum or brain effective site concentration based on such
patient parameters as height, weight, gender and/or age.
[0102] During operation of the system when an internal or external
event occurs, such as the activation of a system or patient health
monitor alarm or a physician or patient request for increased drug,
electronic controller 14 determines the desired amount of
intravenous drug (or fractional amount of O.sub.2, gaseous drug and
air in the total gas flow) as the function of such event. The
actual IV drug concentrations (or gaseous drug/O.sub.2/air
fractions) are then calculated. These actual calculated amounts
will not always be the same as those requested (e.g., by the user,
patient or system) because of the often complex relationship
between drug or drug and gas mixtures. In sum, drug mix fractions
are typically calculated when, for example, an alarm levels change,
alarm time-outs occur (e.g., there is no silencing of an initial
alarm by the user), a user requests a change, the patient requests
a change, when a procedure begins (system resorts to default
values) and when a controller clock triggers.
[0103] In a preferred embodiment of the invention delivering
gaseous drugs, flow controllers in mixer 44 (detailed in FIG. 8)
determine the total fresh gas flow (FGF) which is the sum of the
volumes of each gas being controlled, namely, the gaseous drug,
oxygen and atmospheric air. Solenoid valves are opened
proportionally to achieve the desired FGF and fractional amount of
each gas. Flow controllers 133, 135 close the feedback loop on the
gas fractions by measuring the FiO.sub.2 and fraction of inspired
gaseous drug in the manifold system 46 and adjusting the mixer
solenoid valves accordingly.
[0104] In one aspect of the invention, the flow controllers 133,
135 match the FGF with patient minute ventilation rates. The minute
ventilation rate is the volume of breath one inhales and then
exhales (e.g., in cubic centimeters or milliliters) in one minute.
A patient's respiratory physiology is balanced at this minute
ventilation. The care system optimizes FGF rates by matching gas
delivery to patient minute ventilation rates. This conserves gas
supplies, minimizes the release of anesthesia gases into the
operating environment, and helps balance respiratory function. For
example, if the FGF is less than the minute ventilation, INPRV 154
will open to supplement the air flow (INPRV 154 being a mechanical
system not under electronic control).
[0105] In an additional aspect of the invention, the care system
will not only measure and monitor minute ventilation as described
above, but also "effective minute ventilation" and thereby improve
the quantitative information about patient physiology considered by
the system. "Effective minute ventilation" is a term used herein to
mean the amount of gas that is actually involved in respiratory gas
exchange between the alveolar sacs of the lungs and the capillary
blood surrounding those sacs (as opposed to simply the volume of
gas one inhales and then exhales, "tidal volume"). This measure may
be arrived at by subtracting the volume of anatomical space imposed
between the air source (e.g., mouth) and the transfer of gas at the
alveolar sacs (estimated from the patient's height and weight),
from the tidal volume of gas to arrive at "effective tidal volume."
The effective tidal volume is then multiplied by respiratory rate
to arrive at "effective minute ventilation."
[0106] FIG. 10A details manual bypass system 4 (FIG. 5) which is
coupled to manifold system 46. The bypass system 4 includes a
self-inflating resuscitation bag (SIRB) 19a (also shown in FIG. 3B)
which is a manual pump with which the user can provide air
intermittently to the patient through a bypass air line 90. A quick
disconnect type fitting 91 (such as that disclosed in Hickle above)
couples SIRB 19a with manifold system 46 and provides rapid
attachment thereto. A manual flow control valve 92 opens or closes
bypass air line 90. When line 90 is open, manual flow control valve
92 can be adjusted to provide the necessary air flow. A flow meter
94 placed in bypass air line 90 provides a visual display to the
user of the status of air flowing through the bypass air line 90.
The above-described manual bypass system 4 provides the patient
with manually-controlled flow of air and thus enables air delivery
in the case of an oxygen source system 144 (FIG. 7A) failure.
[0107] FIG. 10B details scavenger pump system 48 (FIG. 6) which is
integrated into the care system and vacuums exhaled gases from
manifold system 46 through a scavenging line 85. A filter 86 in
scavenging line 85 removes contaminants from the gases which have
been exhaled from the patient and which are flowing through the
scavenger line 85. Pressure regulator 87 receives the filtered
gases and ensures that the vacuum pressure is maintained in vacuum
pump 95 downstream at a reasonable working level. Flow restrictor
88 sets the flow rate through the vacuum 95 for a given vacuum
pressure. Check valve 89 downstream of flow restrictor 88 provides
one-way flow of scavenged gases, and thus ensures that back-flow
does not inadvertently flow into scavenger system 48 from the
vacuum pump 95 downstream. Vacuum pump 95 provides the vacuum
pressure necessary for scavenging of exhaled gases from the
patient. The pump may be of an electrical type that can be powered
by office standard AC current. As the vacuum pump is integrated
into the care system, a wall vacuum source (such as that typically
in an OR) is not required. Once the gases are vacuumed off, they
are exhausted via exhaust hose 32 (FIG. 3B) to an appropriate area.
The benefit of scavenging system 48 is at least two-fold in that
the system helps assist the patient in the work of breathing and
work environment safety is increased.
[0108] In a preferred embodiment, an emesis aspirator 19 (FIG. 3B)
is integrated into system 10 and may be stored within housing 15.
Emesis aspirator 19 is a manually operated device used to suction a
patient's airway in the event of vomiting. Emesis aspirator 19 does
not require an external vacuum source (e.g., wall suctioning) or
electrical power for operation.
[0109] To enhance the safety of the invention, housing 15 may
include structure integrated adjacent or otherwise near where
emesis aspirator 19 is stored within housing 15 (FIG. 3B) to hold
and prominently display containers of drugs capable of reversing
the effects of various sedatives/analgesics. These "reversal
drugs," such as naloxone, remazicon and others may be immediately
administered to the patient in the event of an overdose of
sedative, analgesic and/or amnestic.
[0110] Referring to FIG. 11, a preferred embodiment of the
invention includes an integrated patient interface system which
combines one or more patient health monitors 252 (additional health
monitors to those shown are also contemplated by the invention)
with additional automated patient feedback devices including a
patient drug dosage increase or decrease request device 254 and an
automated consciousness query system 256 for monitoring a patient's
level of consciousness. These health monitors 252 and automated
patient feedback devices 254, 256 are electronically coupled to
electronic controller 14 via leads (e.g., 50, FIG. 2) and provide
electronic feedback values (signals) representing the patient's
physiological condition to controller 14. Generally, if any
monitored patient parameter falls outside a normal range (which may
be preset by the user or otherwise preprogrammed and stored in
memory device as described above), the nonanesthetist is
immediately alerted, for example, by an alarm, display or other
attention-commanding device. The information obtained from patient
health monitors 252 is displayed on a display device 35 (FIG. 2),
in, for example, continuous wave form or numerics on LEDs, thus
allowing the procedural physician to immediately gain useful
information by reviewing the display device. Preferred embodiments
of displays contemplated by the invention are described in more
detail below.
[0111] A preferred embodiment of one aspect of the invention
integrates drug delivery with one or more basic patient monitoring
systems. These systems interface with the patient and obtain
electronic feedback information regarding the patient's
physiological condition. Referring to FIG. 11, a first patient
monitoring system includes one or more patient health monitors 252
which monitor a patient's physiological conditions. Such monitors
can include a known pulse oximeter 258 (e.g, an Ohmeda 724) which
measures a patient's arterial oxygen saturation and heart rate via
an infra-red diffusion sensor; a known capnometer 184 (e.g., a
Nihon Kohden Sj5i2) which measures the carbon dioxide levels in a
patient's inhalation/exhalation stream via a carbon dioxide sensor
and also measures respiration rate; and a known non-invasive blood
pressure monitor 262 (e.g., a Criticon First BP) which measures a
patient's systolic, diastolic and mean arterial blood pressure and
heart rate by means of an inflatable cuff and air pump. A care
system constructed in accordance with this invention may include
one or more of such patient health monitors. Additional integrated
patient health monitors may also be included, such as, for example,
a measure of the flow in a patient's airstream, IPG ventilatory
monitoring, a standard electrocardiogram (EKG) which monitors the
electrical activity in a patient's cardiac cycle, an
electroencephalograph (EEG) which measures the electrical activity
of a patient's brain, and an acoustical monitor whose audio signals
may be processed and provided to controller 14 and amplified and
played audibly.
[0112] A second patient monitoring system monitors a patient's
level of consciousness by means of an automated consciousness query
(ACQ) system 256 in accordance with the invention. ACQ system 256
comprises a query initiate device 264 and a query response device
266. ACQ system 256 operates by obtaining the patient's attention
with query initiate device 264 and commanding the patient to
activate query response device 266. Query initiate device 264 may
be any type of a stimulus such as a speaker which provides an
auditory command to the patient to activate query response device
266 and/or a vibrating mechanism which cues the patient to activate
query response device 266. The automated pressurization of the
blood pressure cuff employed in the patient health monitoring
system may also be used as a stimulus. Query response device 266
can take the form of, for example, a toggle or rocker switch or a
depressible button or other moveable member hand held or otherwise
accessible to the patient so that the member can be moved or
depressed by the patient upon the patient's receiving the auditory
or other instruction to respond. In a preferred embodiment, the
query system has multiple levels of auditory stimulation and/or
vibratory or other sensory stimulation to command the patient to
respond to the query. For example, an auditory stimulus would
increase in loudness or urgency if a patient does not respond
immediately or a vibratory stimulus may be increased in
intensity.
[0113] After the query is initiated, ACQ system 256 generates
signals to reflect the amount of time it took for the patient to
activate response device 266 in response to query initiate device
264 (i.e., this amount of time is sometimes referred to as the
"latency period"). ACQ system 256 is electronically coupled to
electronic controller 14 and the signals generated by ACQ system
256 are suitably converted (e.g., employing an A-D converter) and
thereby provided to controller 14. If the latency period is
determined by controller 14, which employs software to compare the
actual latency period with stored safety data set parameters
reflecting safe and undesirable latency period parameters, to be
outside of a safe range, the physician is notified, for example, by
means of an alarm or other attention-commanding device. If no
action is taken by the physician within a pre-set time period,
controller 14 commands the decrease in level of
sedation/analgesia/amnesia by control and operation on electronic
flow controllers 133, 135 of FIG. 8. The values of the signals
reflecting the latency period are displayed on display device 35
(or on LED devices located on housing 15 or on remote control
device 45, FIG. 1) and the physician may thus increase or decrease
drug delivery based on the latency period.
[0114] The patient interface system of FIG. 11 also includes a drug
dosage request device 254 which allows the patient direct control
of drug dosage. This is accomplished by the patient activating a
switch or button to request electronic controller 14 to command the
increase or decrease in the amount of drug he or she is receiving.
For example, if a patient experiences increased pain he or she may
activate the increase portion of the switch of device 254, whereas,
if a patient begins to feel nauseous, disoriented or otherwise
uncomfortable, he or she may request a decrease in drug dosage. In
embodiments where drug delivery is intravenous, such delivery can
be by continuous infusion or bolus. A feedback signal from device
254 representing the patient's increase or decrease in drug dosage
request is electronically communicated to controller 14 which
employs conservative, decision-making software, including
comparison of monitored patient conditions with stored safety
parameters reflecting patient physiological conditions, to effect
safe, optimized drug delivery in response to patient requests. The
amount of increase or decrease administered by controller 14 can be
pre-set by the physician through user access devices such as
keyboard 230, FIG. 2. For example, where the drug being delivered
is nitrous oxide, the approved increase or decrease may be in
increments of .+-.10%. When not activated by the patient, drug
request device 254 remains in a neutral position. The invention
thus integrates and correlates patient-controlled drug delivery
with electronic monitoring of patient physiological conditions.
[0115] In an alternative embodiment, the physician is notified via
user interface system 16 (display device 30 or LEDs remote control
device 45), FIG. 1 of the patient request to increase or decrease
drug dosage and can approve the requested increase or decrease
taking into account the patient's present vital signs and other
monitored physiological conditions, including consciousness level
status as obtained from the various patient interface system
monitors 252, 256 (FIG. 11).
[0116] In a preferred embodiment of the invention, the patient
controlled drug dosage request system 254 has lock-out capabilities
that prevent patient self-administration of drugs under certain
circumstances. For example, access to self-administration will be
prevented by electronic controller 14 under circumstances where
patient physiology parameters or machine state parameters are or
are predicted to be outside of the stored safety data set
parameters. Access to self-administration of drugs could also be
inhibited at certain target levels or predicted target levels of
drugs or combined levels of drugs. For example, if it were
predicted that the combined effect of requested drugs would be too
great, drug delivery in response to patient requests would be
prohibited. It is noted that such predictive effects of drugs could
be determined through the use of various mathematical modeling,
expert system type analysis or neural networks, among other
applications. In short, the invention is designed to dynamically
change drug administration and amount variables as a function of
patient physiology, care system state and predictive elements of
patient physiology.
[0117] Additionally, it is contemplated that patient
self-administration of drugs could be prohibited at times when drug
levels are changing rapidly. For example, if a patient is
experiencing pain and that is apparent to the physician, the
physician may increase the target level of drug while at the same
time the patient requests additional drug. The subject invention
will sequentially address the physician and patient requests for
drug increases and will lock out any patient-requested increases
that are beyond programmed parameters.
[0118] In an additional aspect of the invention, a patient may be
stimulated or reminded to administer drugs based on electronic
feedback from the patient physiology monitoring systems. For
example, if there is an underdosing of analgesics and the patient
is suffering pain evidenced by a high respiratory rate or high
blood pressure reflected in electronic feedbacks to the electronic
controller, the controller can prompt the patient to
self-administer an increase in drugs. This could be accomplished
by, for example, an audio suggestion in the patient's ear. Thus, it
is contemplated that the invention will have an anticipatory
function where it will anticipate the patient's needs for increased
drugs.
[0119] In a preferred embodiment of the invention, one or more
patient vital sign monitoring devices 252, ACQ system devices 256,
and a drug dosage request device 254 are mechanically integrated in
a cradle or gauntlet device 55 (FIG. 2) constructed to accommodate
and otherwise fit around a patient's hand and wrist. FIG. 2 shows
generally hand cradle device 55 electronically coupled by lead 50
to care system 10. One embodiment of a hand cradle device in
accordance with this invention is shown in more detail in FIGS. 12A
and 12B.
[0120] FIG. 12A shows blood pressure cuff 301 capable of being
wrapped around a patient's wrist and affixed to itself such that it
can be held in place. Cuff 301 is affixed to palm support portion
303. Alternatively, the cuff may be separated from palm support
portion 303 and placed on the upper arm at the physician's
discretion. A recessed, generally elliptical or rounded portion 305
is supported by the top edge of palm support portion 303 and is
capable of receiving and supporting the bottom surface of a
patient's thumb. Depressible query response switch 307 is located
within thumb support portion 305 such that switch 307 is capable of
being depressed by the patient's thumb. The thumb support portion
305 may be constructed so as to have a housing, frame, raised walls
or other guide so that a patient's thumb may more easily be guided
to depress or move buttons or switches within portion 305 (here,
switch 307), or so that any significant patient thumb movement
toward the switch will activate same. Supporting thumb support
portion 305 and abutting palm portion 303 is finger support portion
309 for receiving in a wrapable fashion the patient's fingers. Drug
dosage request switch 311 is integrated into finger support portion
309 and is in the form of a rocker switch whereby depressing the
top portion 310a of said switch will effect an increase in the
delivery of sedative, analgesic and/or amnestic whereas depressing
the bottom portion 310b of said rocker switch will effect a
decrease in drug delivery at an appropriate set percentage (e.g.,
.+-.10%, FIG. 12B). Rocker switch 311 is constructed so as to
remain in a neutral position when not being actuated by the
patient.
[0121] FIGS. 13A and 13B show an additional embodiment of the hand
cradle device of this invention. Specifically, a pulse oximetry
sensor 314 is mechanically affixed to and electronically coupled to
hand cradle device 55 abutting the upper end of finger support
portion 309, and being generally planar vis-a-vis the outer edge of
thumb support portion 305. Pulse oximeter 314 is constructed as a
clip which can be placed on a patient's finger. The transmitter and
receiver portions of sensor 314 are contained in the opposite sides
315a, 315b (FIG. 13B) of the finger clip 314 such that when placed
on a finger, infra-red radiation travels through the finger;
through spectral analysis the percentage of oxygenated hemoglobin
molecules is determined. In this embodiment of hand cradle device
55 the query initiate device 313 is in the form of a small vibrator
located in palm support portion 303. Alternatively, to enhance
patient attentativeness to the query initiate device and to
increase patient accuracy in depressing the response switch, the
vibrator may be located adjacent the query response switch 307 or,
in the embodiment of FIG. 14A, adjacent response switch 407.
[0122] In an alternative embodiment of hand cradle device 55, now
referring to FIGS. 14A and 14B, drug dosage request device 409 is
located within thumb portion 405 and is in the form of a slidable
member 409 wherein sliding member 409 forward effects an increase
in analgesic dosage and sliding portion 409 backward effects a
decrease in analgesic dosage (FIG. 14B). In this embodiment of the
invention, query response device 407 is a depressible portion
integrated within finger support portion 409.
[0123] All embodiments of hand cradle device 55 are constructed so
as to be ambidextrous in nature, namely, they accommodate and are
workable by a patient's right or left hand. For example, in FIGS.
12A and 13A, a second query response switch 307b is located within
a symmetrically opposed thumb portion 305b affixed to the opposite
end of finger portion 309. Similarly the device of FIG. 14A is also
constructed with a symmetrically opposed thumb portion 405b and
drug dosage request device 409b. The pulse oximeter clip 314 is
affixed to finger support portion 309 so as to be mechanically and
electronically quick releasable to permit reversibility when used
on the opposite hand. It should also be recognized that the pulse
oximeter clip 314 may be tethered to hand cradle device 55 rather
than mechanically affixed thereto, or blood pressure cuff 301 and
oximeter clip 314 may be mechanically separate from cradle device
55 and electronically coupled to controller 14 with flexible
leads.
[0124] Referring to FIG. 15, an additional alternative embodiment
of the invention is shown in which hand cradle device 55 includes
mechanically integrated blood pressure cuff 301, query response
device 307 and analgesic request device 309 similar to that
described above. This embodiment, however, includes an ear clip
device 450 capable of being clipped to the lobe of a patient's ear
and being electronically coupled to electronic controller 14 via
lead 456. Referring additionally to FIG. 16, ear clip 450 comprises
a query initiate device 452 in the form of a speaker which provides
an audible command to patient to activate the response switch. Such
speaker may also command a patient to self-administer drugs or play
music to a patient during a procedure. Pulse oximeter 454 is a clip
capable of being affixed to a patient's ear lobe. One side of the
clip being a transmitter and the other side of the clip being a
receiver to effect the infra-red spectral analysis of the level of
oxygen saturation in the patient's blood.
[0125] In an additional aspect of the invention, it is contemplated
that the care system's automated monitoring of one patient health
conditions is synchronized with the monitoring of one or more other
patient health conditions. For example, in a preferred embodiment,
if the controller 14, receives low O.sub.2 saturation, low heart
rate or a low perfusion index feedback information from the pulse
oximeter (e.g., the actual parameter received is in the undesirable
range of the stored safety data set for those parameters), such
feedback will trigger controller 14 to automatically inflate the
blood pressure cuff and check the patient's blood pressure. (This
is because low O.sub.2 saturation can be caused by low blood
pressure; and low heart rate can cause low blood pressure and vice
versa, etc.) Therefore, under normal operating conditions the
preferred embodiment of the invention will automatically check the
patient blood pressure every 3 to 5 minutes, and whenever there is
a change in other patient parameters such as blood O.sub.2
saturation or heart rate. In another example, the electronic
checking of blood pressure is synchronized with the automated
consciousness query because the activation of the cuff may arouse a
patient and affect query response times. Thus the invention
contemplates an "orthogonal redundancy" among patient health
monitors to ensure maximum safety and effectiveness.
[0126] As described above, one aspect of a preferred embodiment of
the invention includes the electronic management of drug delivery
via software/logic controlled electronic controller 14 to integrate
and correlate drug delivery with electronic feedback signals from
system monitors, one or more patient monitor/interface devices
and/or user interface devices. Specifically, electronic signal
values are obtained from care system state monitors; from patient
monitor/interface devices (which can include one or more vital sign
or other patient health monitors 252, ACQ system 256, and/or
patient drug dosage request device 254, FIG. 11); and in some
instances from one or more user interface devices. All are
electronically coupled to, through standard A-D converters where
appropriate, electronic controller 14. The controller 14 receives
the feedback signal values and, via software and programmed logic,
affects a comparison of these values representing the patient's
monitored physiological conditions with known stored data
parameters representing safe and undesirable patient physiological
conditions (a safety data set). Controller 14 then generates an
instruction in response thereto to maintain or decrease the level
of sedation, analgesia, and/or amnesia being provided to the
conscious patient thereby managing and correlating drug delivery to
safe, cost-effective and optimized values (FIG. 2B. Controller 14
is operatively, electronically coupled to electronic flow
controllers 133, 135 (FIG. 8) of electronic mixer 44 which (via
solenoid valves) adjust flow of gaseous drug and O.sub.2 in a
closed-loop fashion as described above. In intravenous embodiments
such flow controllers would adjust the flow of one or more
combination of IV drugs. It should be recognized that the
electronic values provided to microprocessor controller 14 to
effect management and correlation of drug delivery, could include
one or more signals representing patient vital signs and other
health conditions such as pulse oximetry, without necessarily
including signal(s) representing level of patient consciousness,
and vice versa.
[0127] As also indicated above, the software effecting electronic
management of drug delivery by controller 14 employs "conservative
decision-making" or "negative feedback" principles. This means, for
example, that the electronic management of drug delivery
essentially only affects an overall maintenance or decrease in drug
delivery (and does not increase drugs to achieve overall increased
sedation/analgesia). For example, if ACQ system 256 (FIG. 11)
indicates a latency period outside of an acceptable range,
controller 14 may instruct electronic flow controller 133 (FIG. 8)
to increase the flow of oxygen and/or instruct flow controller 135
to decrease the flow of gaseous drug to manifold system 48.
[0128] In another example of such electronic management of drug
delivery by conservative decision-making principles, if ACQ system
256 (FIG. 11) indicates a latency period in response to a patient
query given every 3 minutes outside of an acceptable range,
electronic controller 14 may immediately cease drug delivery, but
at the same time, increase the frequency of times that the patient
is queried, e.g., to every 15 seconds. When the patient does
respond to the query, the drug delivery is reinitiated, but at a
lower overall dose such as 20% less than the original concentration
of drug that had been provided.
[0129] A further example of the invention's electronic management
of drug delivery through conservative, decision-making software
instruction employs known target-controlled infusion software
routines to calculate an appropriate dosage of IV drug based on
patient physical parameters such as age, gender, body weight,
height, etc. Here, a practitioner provides the patient
physiological parameters through the user interface system, the
electronic controller 14 calculates the appropriate drug dosage
based on those parameters, and drug delivery begins, for example,
as a bolus and is then brought to the pre-calculated target level
of infusion. If later there is a significant change in a patient
monitored parameter, e.g., pulse oximetry or latency period falls
outside of a desired range, controller 14 effects a decrease in
overall drug delivery as described above.
[0130] One concern that the invention addresses with respect to the
target controlled infusion of IV drugs is the nature and speed at
which the care system reaches the steady state target level of
drug. For example, an important consideration for the physician is,
once drug administration begins, when is the patient sufficiently
medicated (e.g., sedated or anesthetized), so that the physician
can begin the procedure. It is frequently desirable that the
patient reach the steady state target level of drug as rapidly as
possible so that the procedure can begin as soon as possible. It
has been determined that one way of reaching a suitable level of
drug effectiveness quickly is to initially overshoot the ultimate
steady state target drug level. This shortens the time between the
beginning of drug delivery and the onset of clinical drug
effectiveness so that the procedure may begin. Typically, predicted
target levels have an error of plus or minus 20%, therefore, one
approach of reaching the clinical effectiveness state quickly is to
attempt to reach at least 80% of the ultimate target level, but
initially overshoot that 80% level by giving a 15% additional
increase of drug infusion beyond the 80% target. One method of
accomplishing this is to use currently available PDI controllers
which employ an error state (here the difference between predicted
drug levels in the blood stream and the target level) to arrive at
an infusion rate. Other control systems, however, that allow some
initial overshoot of the target blood level of the drug to get to a
clinical effectiveness level quicker would also be appropriate.
[0131] FIG. 17 is a schematic of an alternative embodiment of an
apparatus constructed in accordance with the invention which is
particularly suitable for remote medical care locations and home
care-type settings for indications such as post-operative or other
post-procedural pain and/or discomfort, including, for example,
nausea secondary to oncology chemotherapy. In this embodiment, drug
source system 442 delivers drugs to the patient (which may be drugs
such as propofol, morphine, remifentanil and others) intravenously
by, for example, use of a known syringe pump-type device capable of
being worn or otherwise affixed to the patient, or delivers such
drugs transdermally by, for example, use of known ion transfer-type
devices, among others. The drug delivery may be continuous or by
drug bolus and without an integrated supply of O.sub.2. If
necessary, oxygen may be supplied to the patient from separate
tanks or an in-house, on-site oxygen source. The resulting
apparatus is simplified--there is no requirement for an integrated
O.sub.2 source, electronic mixer, manifold, or the airway circuit
and face mask devices described above.
[0132] One or more patient health monitors 412 such as known pulse
oximeters, blood pressure cuffs, CO.sub.2 end tidal monitors, EKG,
and/or consciousness monitors, or other monitors such as those
indicated herein, monitor the patient's physiological condition.
Drug dosage may be pre-set by a physician prior to or during
application of drug delivery and/or also patient controlled
thereafter by means of a patient drug dosage increase or decrease
request devices generally of the type of that described above. It
should also be understood that the intravenous delivery of drugs
may be by continuous infusion, target-controlled infusion, pure
bolus, patient-elected bolus or combinations thereof.
[0133] Still referring to FIG. 17, electronic management of drug
delivery in this embodiment of the invention is provided by
electronic controller 414 which may be of a type described above.
Controller 414 employs conservative decision-making software and/or
logic devices to integrate and correlate drug delivery by drug
source system 442 (which may include known solenoid type or other
electronic flow controllers) with electronic feedback values from
one or more patient health monitors 412. The values (signals) from
patient health monitors 412 represent one or more actual patient
monitored physiological conditions. Controller 414, through
software employing comparison protocols such as those described
herein, accesses stored safety data set 410 which contains data
reflecting safe and undesirable patient physiological conditions,
and compares the signals reflecting actual patient monitored
conditions with same. As described above, safety data set 410 may
be stored in a memory device such as an EPROM. Based on the result
of the comparison, controller 414 either instructs no change in
drug delivery or generates a signal instructing the drug flow
controllers of drug source system 442 to manage application of the
drug to safe, optimized levels.
[0134] In certain aspects of the invention, controller 414 may also
access, through software, pre-set parameters stored in a memory
device representing initial or target drug dosages and lock-outs of
patient drug administration requests as described above. In these
circumstances, instruction signals generated by controller 414
would also account for and control drug delivery in accord with
these pre-set parameters.
[0135] This embodiment of the invention would also typically
include system state monitors, such as electronic sensors which
indicate whether power is being supplied to the system or which
measure the flow of drugs being delivered. Such system state
monitors are electronically coupled to controller 414 and provide
feedback signals to same--the control of drug delivery by
controller 414 electronically coupled to drug source system 442 in
response to said feedback signals is similar to that as described
herein with respect to other embodiments.
[0136] In another aspect of the invention, electronic controller
414 is located on a remote computer system and electronically
manages on-site drug delivery integrating and correlating same with
on-site monitoring of patient physiological conditions and care
system states as described above, but here with instructions
signals generated from a remote location. It is contemplated that
controller 414 may, in some embodiments, effect transmission via
modem or electronic pager or cellular-type or other wired or
wireless technologies of electronic alarm alerts to remote
locations if a monitored patient parameter such as the percentage
of oxygen absorbed into the blood (SO.sub.2).sub.p falls outside of
a safe established value or range of values as established by the
stored safety data set. Such remote locations could thereby summon
an ambulance or other trained caregiver to respond to the alarm
alert.
[0137] FIG. 18 details the user interface system of a preferred
embodiment of the invention. This system enables the physician to
safely and efficaciously deliver one or more of sedation, analgesia
or amnesia to a patient while concurrently performing multiple
tasks. The user interface permits the physician to interact with
the care system and informs the user of the patient's and system's
status in passive display devices and a variety of active
audio/visual alarms thereby enhancing the safety and enabling
immediate response time (including the "conservative" responses,
e.g., detailed drug delivery discussed above) to abnormal
situations.
[0138] Specifically, a keypad and/or touch screen 230 (FIGS. 2 and
18) allows the physician to interact with electronic controller 14,
inputting patient background and setting drug delivery and oxygen
levels. A remote control device 45 (FIGS. 1 and 18) provides the
physician with remote interaction with the care system 10 allowing
him or her to remotely control the functions of the system. Remote
control device 45 may be removably integrated into the top surface
of housing 15 and capable of being clipped onto material close to
the physician and/or patient. In one aspect of the invention, the
remote control device 45 itself contains display devices such as
LEDs to advise the physician of patient and system parameters. A
panic switch 232 (FIG. 18), which may be on-board housing 15 (FIG.
1) or contained in remote control device 45 and electronically
coupled to controller 14 allows the physician to shut down care
system 10 and maintains it in a safe state pre-programmed into
controller 14.
[0139] Visual display devices 234 (FIG. 2, 35) display actual and
predictive or target patient and system parameters and the overall
operation status of the care system.
[0140] One version of a preferred embodiment of visual display 234
is shown in FIG. 22. The display 2230 includes a first portion of
the display 2234 which is devoted to displaying to the user the
current status of the system operation and monitored patient
conditions, including the status of any alarm caused by a change in
monitored system or patient condition. For example, if a patient's
timed response to a consciousness query (latency period) is outside
an established range and an alarm is thus activated, that query
latency period is displayed in this first portion 2234 of the
visual display, thereby enabling the physician to immediately
understand the cause of the alarm.
[0141] The visual display device 2230 of this embodiment also
includes a second portion of the display 2236 which is devoted to
displaying the actions taken or soon to be taken by the care
system. For example, if in response to an alarm indicating a
latency period outside of an established safe range the apparatus
will decrease the flow of drug to the patient, this second portion
2236 displays the percentage decrease in drug dosage to be
affected.
[0142] Visual display 2230 facilitates the physician's interaction
with the apparatus by walking the physician through various system
operation software subprograms. Such subprograms may include system
start-up where a variety of system self-checks are run to ensure
that the system is fully functional; and a patient set-up. To begin
the procedure, the care system monitors are placed on the patient
and the physician activates the system by turning it on and
entering a user ID (it is contemplated that such user ID would only
be issued to physicians who are trained and credentialed). Next,
the visual display would prompt the physician to begin a pre-op
assessment, including inputting patient ID information and taking a
patient history and/or physical. In the pre-op assessment, the
physician poses to the patient a series of questions aimed at
determining appropriate drug dosage amounts (such as age, weight,
height and gender), including factors indicative of illness or high
sensitivity to drugs. The responses to such questions would be
inputted into the care system and employed by the system to assist
the physician in selecting the appropriate dose amount. For
example, the care system may make available to the physician one
range of dosage units for a healthy person and a narrower range of
dosage units for a sick or older person. The physician would have
to make an explicit decision to go above the recommended range.
[0143] In addition to the pre-op assessment performed by the
physician described above, it is also contemplated that the care
system is capable of performing an automated pre-op assessment of
the patient's physiology. For example, with the monitors in place,
the care system will assess such parameters as the oxygenation
function of the patient's lungs and/or the ventilatory function of
the patient's lungs. The oxygenation function could be determined,
for example, by considering the A-a gradient, namely, the alveolar
or lung level of oxygen compared to the arteriolar or blood level
of oxygen. The ventilatory function of the lungs could be
determined from pulmonary function tests (PFTs), among other
things, which are measurements of the amount of air and the
pressure at which that air is moved in and out of the lungs with
each breath or on a minute basis. (It is contemplated that these
assessments are performed before the procedure begins and during
the procedure as a dynamic intra-operative assessment as well.)
Also during the pre-op (or as a continuous intra-operative)
assessment, heart function may be assessed by viewing the output of
an EKG to determine whether there is evidence of ischemia or
arrhythmias. Alternatively, automated algorhythms could be applied
to the EKG signals to diagnose ischemia or arrhythmias. Additional
automated patient health assessments could also be made.
[0144] During patient set-up, current patient and system parameters
may also be assessed and displayed, and the consciousness-query
system and patient drug increase/decrease system tested and
baselined. A set drug subprogram allow for the selection of drugs
and/or mixture of drugs (or drug, oxygen and air), allows for
picking target levels of drugs, and/or permits enabling of the
patient's self-administration of drugs within certain ranges. The
invention also contemplates during the pre-op assessment
determining a sedation threshold limit for the given patient in the
unstimulated state. This could be done as a manual check, i.e., by
simply turning up the drug levels and watching the patient manually
or the procedure could be automated where the drugs are increased
and the safety set parameters such as those for latency
(consciousness queries) are tested as the concentration at the drug
effect site is increased.
[0145] The system and patient status and system action may be
displayed during, for example, a sedation subprogram. Visual
display device 2230 may include graphical and numeric
representations of patient monitored conditions such as patient
respiratory and ventilatory status, consciousness, blood O.sub.2
saturation, heart rate and blood pressure (2238); an indication of
elapsed time from the start of drug delivery (2239); drug and/or
O.sub.2 concentrations (2241); and indications of patient requests
for increases or decreases in drug (2243). The actual fraction of
inspired oxygen calculated may also be displayed. Command "buttons"
are included to mute alarms (2240), change concentration of drug
delivered (2242), turn on or off the mixing of an oxygen stream
with atmospheric air (2244), and to turn on or off or make other
changes to the automated consciousness query system (2246). Command
buttons may also be included to place the apparatus in a "recovery"
mode once the procedure is completed (patient parameters are
monitored, but drug delivery is disabled) (2248), and to end the
case and start a new case (2250) or shut-down the system.
[0146] An alternate version of a preferred embodiment of the visual
display portion of the invention is shown in FIG. 22A. Portions
2202, 2204, 2206 and 2208 of display device 2200 show current
patient O.sub.2 saturation, blood pressure, heart rate, and end
tidal CO.sub.2 levels, respectively. These portions displaying
patient physiological state are uniquely color coded. Smart alarm
box portion 2212 which may be coded in an attention getting color
such as red, displays to the physician the particular alarm that
has sounded. For example, if the patient O.sub.2 blood saturation
level falls below safe levels, the O.sub.2 saturation alarm will
sound and the O.sub.2 saturation level will appear in smart alarm
box portion 2212 where it can be easily seen by the physician. In
short, whatever parameter has alarmed is moved to the smart alarm
box portion; the specific alarm indicator is moved to the same
place every time an alarm sounds. Also, the level of criticality of
the alarm which, as described below, in a preferred embodiment may
be indicated by either yellow or red color, is displayed in the
patient physiological parameter portion of the display. For
example, if a red level O.sub.2 saturation alarm sounds, the
background portion of the O.sub.2 saturation portion 2202 will
appear in red. Portion 2214 of display 2200 shows the past, present
and predicted levels (2215) of drug administration (the drug levels
shown in FIG. 22A are the levels of nitrous oxide remifentanil and
propofol). In a preferred embodiment target controlled infusion
past, present and predicted levels are shown graphically beginning
with the past thirty minutes and going thirty minutes into the
future. The invention also contemplates bracketing a range of
accuracy of target controlled infusion levels (not shown).
[0147] Display portions 2220 and 2224 depict graphical
representations of patient health parameters such as the A-a
gradient (oxygenation function) for the lungs, the results of
pulmonary function tests, electrocardiogram, and blood O.sub.2
saturation, among others.
[0148] In another aspect of the invention, visual display 35 (FIG.
1) may be removably integrated into the top surface of housing 15
and capable of being removed from housing 15 and affixed to a frame
near the patient, such as a gurney rail or examination table.
Alternatively, or in addition thereto, a heads-up type visual
display device is provided to facilitate a nonanesthetist's
involvement in the medical or surgical procedure while
simultaneously being able to view the status of system and patient
monitored values and the details of alarm states. In this case, the
display device is miniaturized and mounted onto a wearable headset
or eyeglass-type mount or mounted on an easily viewed wall
display.
[0149] Referring again to FIG. 18, in a preferred embodiment,
audible alarms 236 alert the physician when patient or system
parameters are outside of the normal range. In preferred
embodiments, the alarms may be two or three stages with different
tones to indicate different levels of concern or criticality. As is
described above, when an alarm sounds, the user is able to
immediately view the cause of the alarm because the smart alarm box
portion 2212 of the visual display 2200 shows the value of the
monitored system or patient parameter that caused the alarm to
activate.
[0150] FIG. 21 shows examples of drug delivery management protocols
for three-stage alarms responsive to patient monitors, namely,
alarms "1," "2" and "3," in accordance with a preferred embodiment
of one aspect of the invention. These alarms may have different
tones or other indicators to denote different levels of concern or
criticality. The dataflow diagram of FIG. 23 depicts one example of
the steps performed by the drug delivery managing software or logic
for one such protocol, namely, one where electronic controller 14
described above receives an electronic feedback signal from a pulse
oximeter monitoring the actual amount of oxygen saturation in a
patient's blood (the value indicated by "SpO.sub.2"). As is shown,
the SpO.sub.2 value is compared with stored safety data set 220
containing a parameter value or range of parameters values
reflecting safe and undesirable patient blood oxygen saturation
conditions. If the SpO.sub.2 value is greater than or equal to
stored parameter 90%, no alarm sounds and no adjustment to drug
delivery is effected (221a). If the SpO.sub.2 value is less than
90%, but greater than 85% (221b), alarm 1 sounds for 15 seconds
(222). If alarm 1 is silenced manually (222a), no further action is
taken by the system. If alarm 1 is not silenced, the amount of drug
being delivered (in this example gaseous N.sub.2O) is reduced to
the lesser of a concentration of 45% or the current concentration
minus 10% (223). The software/logic procedure would operate in a
similar fashion for intravenous and nebulized forms of drugs and
the instructions provided (e.g., as in 223) would be specified for
safe dosages of such drugs.
[0151] Further, if the value of oxygen saturation (SpO.sub.2) is
less than 85%, but greater than or equal to 80% (221c), alarm 2
sounds and the amount of N.sub.2O being delivered is immediately
reduced to the lesser of a concentration of 45% or the current
concentration minus 10% (224). If the feedback value SpO.sub.2 from
the pulse oximeter indicates that the oxygen saturation in the
blood is less than 80%, alarm 3 sounds and the amount of N.sub.2O
being delivered would be immediately reduced to 0% (225).
[0152] Similar protocols are described in FIG. 21 for electronic
feedback signals from patient health monitors indicating pulse
rate, amount of carbon dioxide in a patient's end tidal
exhalations, respiration rate, systolic blood pressure, and
feedback from the automated consciousness monitoring system
constructed in accordance with the invention. These protocols are
effected with software (and/or logic) operating in similar fashion
to that described in the dataflow diagram of FIG. 23. That is, the
protocol shown in FIG. 23 is one example employing one patient
monitored parameter, but the operation of the invention would be
similar to affect the remaining protocols of FIG. 21.
[0153] It should be understood that the system responses to alarms
(described above in terms of decreases or cessation of drug
concentration) could also include institution and/or increases in
administration of oxygen in accord with patient and system state
parameters as described above. In circumstances where drugs are
halted and pure oxygen (or an O.sub.2 atmospheric mix) is provided,
e.g., where feedback signals indicate the patient has a low blood
O.sub.2 saturation, a preferred system is designed to operate in a
LIFO ("last-in-first-out") manner. This means that when controller
14 receives feedback signaling an adverse patient or machine state
and instructs flow controllers to turn on the oxygen, the very next
breath the patient takes will be of pure O.sub.2 (and/or
atmospheric air) rather than of a drug/air mixture. This may be
accomplished, for example, by supplying O.sub.2 for air directly to
PIV 152 (FIG. 9A) and bypassing reservoir bag 149.
[0154] FIG. 21A shows examples of drug delivery management
protocols for two-stage alarms responsive to system state monitors,
namely, alarms "1" and "2," in accordance with a preferred
embodiment of one aspect of the invention. The alarms may have
different tones or other indicators to note different levels of
concern or criticality. The dataflow diagram of FIG. 23A depicts
one example of the steps performed by the drug delivery managing
software and/or logic for one such protocol, namely, one where
electronic controller 14 (e.g., FIG. 2A) receives an electronic
feedback value from an O.sub.2 tank pressure sensor (519)
indirectly measuring the amount of oxygen remaining in an on-board
oxygen tank (the value indicated by "O.sub.2 remaining"). As is
shown, the O.sub.2 remaining value is compared with an established
data set of safe system parameters stored in a memory device as
described above, said data set containing a "setpoint" reflecting
known safe and undesirable oxygen tank pressure conditions (520).
If the oxygen pressure is greater than the setpoint, no alarm
sounds and no adjustment to drug delivery is effected (521). If the
O.sub.2% value is less than the setpoint, alarm "1" sounds (522).
If alarm "1" is silenced manually within 15 seconds, no further
action is taken by the system (523). If alarm "1" is not silenced
within 15 seconds, the amount of drug being delivered (in this
example gaseous N.sub.2O) is reduced to the lesser of the
concentration of 45% or the current concentration minus 10% (524).
The software or logic procedure would operate in a similar fashion
for intravenous and nebulized forms of drugs and the instructions
provided (e.g., as in 524), would be specified for safe dosages of
such drugs.
[0155] In another example of FIG. 21A involving a system state
monitor which indicates whether power is being supplied to
apparatus 10, a logic operation determines whether power has been
interrupted. If the system state monitor for power signals that
power has been interrupted, alarm "2" sounds and the delivery of
drug is reduced to 0%.
[0156] Similar protocols are described in FIG. 21A for system state
monitors indicating O.sub.2 interruption fail safe, total gas flow,
drug tank pressure, fraction of inspired oxygen (FIO.sub.2), and
operation of the vacuum pump for scavenging system 48 (FIG. 6).
These protocols are effected with software (and/or logic) operating
in similar fashion to that described in the dataflow diagram of
FIG. 23A. That is, the protocol shown in FIG. 23A is one example
employing one system state monitor stored parameters, but the
operation would be similar to effect the remaining protocols of
FIG. 21A.
[0157] In the above examples, involving response to patient
physiological state, there is a time lapse between the alarm's
sounding and any decrease in drug delivery to the patient. In
alternate protocols contemplated by the invention, electronic
controller 14 will immediately cease or curtail drug administration
upon the sounding of an alarm. For less critical ("yellow") alarms,
drug delivery may be decreased to 80% levels upon the sounding of
the alarm; for more critical ("red") alarms, drug delivery would
cease upon the sounding of the alarm. In either case, the physician
will then be given time, for example, thirty seconds, to instruct
controller 14 to restart the drug delivery (e.g., the physician
will need to override the curtailing of drug delivery). If the
physician does override controller 14, drugs are reinitiated, for
example, by a bolus amount. This method prevents against a
patient's deteriorating while a physician waits to respond to an
alarm at current drug levels, and also avoids underdosing by
permitting the physician sufficient time to reinitiate drug
delivery.
[0158] Referring again to FIGS. 2 and 18, a printer 238 (FIG. 2,
37) provides an on-site hard copy of monitored patient health
parameters (e.g., the feedback values from the one or more patient
health monitors), as well as alarm states with time stamps
indicating which type of alarms sounded, why and when. Diagnostic
LEDs 240 affixed to the exterior of apparatus 10 (e.g., FIG. 1) and
electronically coupled to controller 14 permit the physician
typically involved in the procedure to ascertain system states at a
glance; LEDs coupled to microprocessor controller 14 also permit
service technicians to assess fault states.
[0159] A preferred embodiment of the invention includes a variety
of peripheral electronic devices, one group internal to or
integrated within housing 15 of apparatus 10 (e.g., FIG. 1) and a
second group on-board electronic controller 14. These electronic
devices ensure proper operation of various aspects of system 10,
including providing hardware status feedback through sensors to
ensure that the apparatus is operating within its desired
parameters. FIGS. 19A and 19B describe various peripheral devices
in accordance with the invention, such devices may be of a known,
off-the-shelf types currently available. Specifically, internal
solenoid-type activated door locks 190 restrict access to the
interior of apparatus 10. Door locks 190 are located within housing
15 (FIG. 1) and are electronically coupled to and controlled by
controller 14 by means of software that includes protocols for
password protection. Access to the interior of apparatus 10 is thus
restricted to authorized personnel with passwords. This is intended
to, among other things, minimize chances of "recreational" abuse of
the pharmaceuticals (e.g., N.sub.2O) contained therein. Internal
door status sensors 191 located within housing 15 and
electronically coupled to controller 14 generate signals indicating
if an access door to the interior of apparatus 10 is open or
closed. Real-time clock 192 on-board controller 14 enables said
controller 14 to provide time stamps for overall system and patient
activities and thereby enables creation of an accurate log of the
operation of care system 10. On-board ambient temperature sensor
193 monitors the exterior temperature signaling same to controller
14 which through software comparison type protocols confirms that
apparatus 10 is being operated under desired conditions with
respect to surrounding temperature. Internal battery temperature
sensor 194 located within housing 15 and electronically coupled to
controller 14 generates signals to same indicating whether the
back-up battery power system is functioning correctly and not
overcharging. Tilt sensor 195 located on-board controller 14
signals same if the apparatus 10 is being operated at an angle
beyond its designed conditions.
[0160] In a preferred embodiment, the software control processes of
electronic controller 14 are stored in a standard flash memory 196
and SRAM type battery-backed memory 197 stores system, patient and
other status information in the event of an AC power loss. On-board
fault detection processor (FDP) 198 signals failures to controller
14 and is a secondary microprocessor based computing system which
relieves controller 14 of its control duties if a fault is detected
in operation. On-board watch dog timer 199 indicates to controller
14 that the apparatus 10 is functioning and resets controller 14 if
system 10 fails to respond.
[0161] A preferred embodiment of the invention also includes a
standard serial port interface, such as an RS-232C serial port, for
data transfer to and from electronic controller 14. The port
enables, for example, downloading software upgrades to and transfer
of system and patient log data from controller 14. An interface
such as a PC Type III slot is also provided to enable the addition
of computer support devices to system 10, such as modems or a LAN,
to be used, for example, to transfer billing information to a
remote site; or to permit diagnosis of problems remotely thereby
minimizing the time required for trouble-shooting and
accounting.
[0162] It should be understood that the care system of the
invention may be modular in nature with its functions divided into
separable, portable, plug-in type units. For example, electronic
controller 14, display devices (FIG. 2, 35) and one or more patient
health monitors would be contained in one module, the pneumatic
systems (flow controllers, pressure regulators, manifold) in a
second module, and the base (FIG. 3B, 17), oxygen and drug tanks
(FIG. 2, 54), scavenger system and vacuum pump (FIG. 3B, 32) in a
third module. Additionally, the patient health monitors or drug
delivery aspects of the system may each be their own plug-in type
modules. The system, for example, may provide for a pluggable
ventilator type module. This modularity enables the system not only
to be more easily portable, but also enables use of certain
features of the system (such as certain patient health monitors),
while not requiring use of others.
[0163] FIG. 20 depicts a preferred embodiment of a patient
information and billing system capable of being interfaced with
care system 10 (FIG. 1) to allow billing or other gathering of
patient information to take place locally at the place of use or
remotely at a billing office. Specifically, information/billing
storage system 280, which may be of a known type
microprocessor-based computing system controlled by software,
collects and stores patient data 281 such as the patient's name,
address and other account information, as well as metered system
operation data 282 generated during operation of apparatus 10 and
stored in controller 14 such as start time, time of use, frequency
of use, duration of patient monitoring, amount of gases expended,
and other such parameters. User access device 283 which may be of a
standard keyboard type permits the physician to interact with
information/billing storage system 280 to input additional data
such as pre-determined treatment or billing parameters or to read
the status of same (e.g., to read the status of metered system
operation parameters 282). Preferably, a password is provided to
permit access to information/billing system 280.
[0164] At the termination of a medical or surgical procedure or at
some other desired period, information/billing storage system 280
processes the received data and transmits same to revenue/billing
processing center 286 at a remote location. Revenue/billing
processing center 286 may be of a known, mainframe-type computing
system such as that manufactured by International Business Machines
(IBM) or a known client-server type computer network system. At the
remote location a patient invoice is generated by printer 287 as
may be other revenue records used for payment to vendors, etc.
[0165] The invention also contemplates that an automated record of
the system operation details will be printed at the user site on
printer 285 which is preferably located on-board apparatus 10 (FIG.
1). Such system operation details may include, for example, all
alarm and actual system operation states, drug flow rates and/or
monitored actual patient physiological conditions as supplied by
electronic controller 14. A modem or LAN may be used to send and
receive billing and other information remotely and to communicate
with remote client/server or other networks 288 as described
above.
* * * * *