U.S. patent application number 11/158253 was filed with the patent office on 2006-03-02 for bite block assembly.
Invention is credited to James F. Martin, Johnson Watson JR. McRorie.
Application Number | 20060042637 11/158253 |
Document ID | / |
Family ID | 35941292 |
Filed Date | 2006-03-02 |
United States Patent
Application |
20060042637 |
Kind Code |
A1 |
Martin; James F. ; et
al. |
March 2, 2006 |
Bite block assembly
Abstract
A bite block assembly for use during a diagnostic, surgical or
other medical procedure is disclosed. This device includes a bite
block body for insertion into the mouth of a patient containing two
passageways, the first, a through passageway, positioned to receive
a medical instrument to be inserted into the patient, the second,
an air-sampling passageway, provides a pathway for exhaled air to
exit the mouth of the patient. The air-sampling passageway is
constructed to receive a gas sampling tube partially disposed in
the air-sampling passageway or completely disposed in the
air-sampling passageway. The gas sampling tube connects a
respiratory cannula with gas sampling port, located on the face of
the patient to the air-sampling passageway of the bite block.
Inventors: |
Martin; James F.; (Lebanon,
OH) ; McRorie; Johnson Watson JR.; (Lebanon,
OH) |
Correspondence
Address: |
PHILIP S. JOHNSON;JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
35941292 |
Appl. No.: |
11/158253 |
Filed: |
June 21, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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60629137 |
Nov 18, 2004 |
|
|
|
60605717 |
Aug 31, 2004 |
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Current U.S.
Class: |
128/207.18 ;
128/206.11 |
Current CPC
Class: |
A61M 16/085 20140204;
A61M 16/0493 20140204; A61M 2205/3561 20130101; A61M 2205/7536
20130101; A61M 16/0808 20130101; A61B 5/682 20130101; G16H 40/63
20180101; A61M 5/162 20130101; A61M 16/0677 20140204; A61M 2209/084
20130101; A61M 2210/0618 20130101; G16H 20/17 20180101; A61B 5/6819
20130101; A61M 5/172 20130101; A61M 16/024 20170801; A61M 2202/0208
20130101; A61M 2205/505 20130101; A61M 2230/205 20130101; A61M
2205/3584 20130101; A61B 5/411 20130101; A61M 16/0688 20140204;
A61M 2016/1025 20130101; A61M 2210/0662 20130101; A61M 16/0672
20140204; A61M 2016/0027 20130101; A61M 5/16831 20130101; A61M
2205/3334 20130101; A61M 2210/0625 20130101; A61M 2205/05 20130101;
A61M 2205/273 20130101; A61M 2205/13 20130101; A61M 2230/432
20130101; A61B 5/7495 20130101; A61M 2205/6072 20130101; A61M
2205/12 20130101; A61B 5/0836 20130101; A61M 5/142 20130101; A61M
16/0858 20140204; A61M 5/14228 20130101; A61M 2205/3553 20130101;
A61M 2021/0027 20130101; A61M 16/0051 20130101; A61M 21/02
20130101; A61M 2230/63 20130101; A61M 2205/14 20130101; A61M
2202/048 20130101; A61M 2230/30 20130101; A61M 2202/062 20130101;
A61M 2205/123 20130101; A61M 2230/06 20130101; A61M 2230/04
20130101 |
Class at
Publication: |
128/207.18 ;
128/206.11 |
International
Class: |
A62B 7/10 20060101
A62B007/10; A61M 15/08 20060101 A61M015/08 |
Claims
1. A bite block comprising a bite-block body adapted for insertion
into the mouth of a patient, wherein the bite-block body includes a
through passageway and includes an air sampling passageway spaced
apart from the through passageway, wherein the through passageway
is adapted for receiving therethrough a medical instrument, and
wherein the air sampling passageway has an inlet disposed to
receive exhaled air from the patient when the bite-block body is
inserted into the mouth of the patient and has an outlet adapted
for coupling to a respiratory gas sampling port of a cannula.
2. The bite block of claim 1, wherein the outlet of the air
sampling passageway is adapted for indirectly coupling to the
respiratory gas sampling port of the cannula through a connector
tube.
3. A cannula assembly comprising: a) a cannula disposable on the
face of a patient and including a respiratory gas sampling port; b)
a bite block having a bite-block body adapted for insertion into
the mouth of a patient, wherein the bite-block body includes a
through passageway and includes an air sampling passageway spaced
apart from the through passageway, wherein the through passageway
is adapted for receiving therethrough a medical instrument, and
wherein the air sampling passageway has an inlet disposed to
receive exhaled air from the patient when the bite-block body is
inserted into the mouth of the patient and has an outlet; and c) a
connector tube having a first end attached or attachable to the
respiratory gas sampling port of the cannula and having a second
end attached or attachable to the bite-block body at the outlet of
the air sampling passageway of the bite-block body.
4. A bite block assembly comprising: a) a bite-block body adapted
for insertion into the mouth of a patient, wherein the bite-block
body includes a through passageway adapted for receiving
therethrough a medical instrument; and b) an air sampling tube
attached to the bite-block body, having an inlet disposed to
receive exhaled air from the patient when the bite-block body is
inserted into the mouth of the patient, and having an outlet
attached or attachable to a respiratory gas sampling port of a
cannula.
5. The bite block assembly of claim 4, wherein the air sampling
tube is at least partially disposed within the through
passageway.
6. The bite block assembly of claim 5, wherein the air-sampling
tube extends completely through the through passageway.
7. The bite block of claim 4, wherein the outlet of the air
sampling tube is adapted for indirect attachment to the respiratory
gas sampling port of the cannula through a connector tube.
8. A bite block assembly comprising: a) a bite-block body adapted
for insertion into the mouth of a patient, wherein the bite-block
body includes a through passageway adapted for receiving
therethrough a medical instrument and includes an air sampling
passageway; and b) an air sampling tube at least partially disposed
within the air sampling passageway, having an inlet disposed to
receive exhaled air from the patient when the bite-block body is
inserted into the mouth of the patient, and having an outlet
attached or attachable to a respiratory gas sampling port of a
cannula.
9. The bite block assembly of claim 8, wherein the outlet of the
air sampling tube is adapted for indirect attachment to the
respiratory gas sampling port of the cannula through a connector
tube.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of earlier filed
provisional applications entitled "Medical Effector System Such As
a Sedation Delivery System (SDS) and Components Which Can Be Used
Therein", Ser. No. 60/629,137, filed on Nov. 18, 2004 and "Medical
Effector System Such As a Sedation Delivery System (SDS) and
Components Which Can Be Used Therein", Ser. No. 60/605,717, filed
on Aug. 31, 2004, both of which are incorporated by reference
herein.
RELATED APPLICATIONS
[0002] The present application relates to the following commonly
assigned patent applications "Medical Effector System"
[END5298USNP], Ser. No. ______; "Apparatus For Monitoring A Patient
During Drug Delivery" [END5298USNP2], Ser. No. ______; "Drug
Delivery Cassette" [END5298USNP3], Ser. No. ______; "Apparatus For
Delivering Oxygen To A Patient Undergoing A Medical Procedure"
[END5298USNP4], Ser. No. ______; "Infusion Pump" [END5298USNP5],
Ser. No. ______; "Capnometry System For Use With A Medical Effector
System" [END5298USNP6], Ser. No. ______; "Device For Connecting A
Cannula To A Medical Effector System" [END5298USNP7], Ser. No.
______; "Apparatus To Deliver Oxygen To A Patient" [END5298USNP8],
Ser. No. ______; "Single Use Drug Delivery Components"
[END5298USNP9], Ser. No. ______; "Drug Delivery Cassette And A
Medical Effector System" [END5298USNP10], Ser. No. ______; "Oral
Nasal Cannula" [END5298USNP11], Ser. No. ______; all filed
concurrently herewith; and Dose Rate Control, Ser. No. 10/886,255,
filed on Jul. 7, 2004; BIS Closed Loop Anesthetic Delivery, Ser.
No. 10/886,322, filed on Jul. 7, 2004; Patient Monitoring Systems
and Method of Use, Ser. No. 10/791,959, filed on Mar. 3, 2004;
Air-Bubble-Monitoring Medication Assembly, Medical System and
Method, Ser. No. 10/726,845, filed on Dec. 3, 2003; Cannula
Assembly and Medical System Employing a Known CO.sub.2 Gas
Concentration, Ser. No. 10/701,737, filed on Nov. 5, 2003;
Automated Audio Calibration for Conscious Sedation, Ser. No.
10/674,244, filed on Sep. 29, 2003; Response Testing for Conscious
Sedation Using Finger Movement Response Assembly, Ser. No.
10/674,184, filed on Sep. 29, 2003; Personalized Audio Requests for
Conscious Sedation, Ser. No. 10/674,185, filed on Sep. 29, 2003;
Response Testing for Conscious Sedation Utilizing a
Non-Ear-Canal-Contacting Speaker, Ser. No. 10/674,183, filed on
Sep. 29, 2003; Response Testing for Conscious Sedation Involving
Hand Grip Dynamics, Ser. No. 10/674,160, filed on Sep. 29, 2003;
Response Testing for Conscious Sedation Utilizing a Hand Motion
Response, Ser. No. 10/673,660, filed on Sep. 29, 2003; Response
Testing for Conscious Sedation Utilizing a Cannula for
Support/Response, Ser. No. 10/670,453, filed on Sep. 25, 2003; Time
Variant Vibration Stimulus Response for a Conscious Sedation
System, Ser. No. 10/670,489, filed on Sep. 25, 2003; Response
Testing for Conscious Sedation using Cableless Communication, Ser.
No. 10/671,183, filed on Sep. 25, 2003; System and Method for
Monitoring Gas Supply and Delivering Gas to a Patient, Ser. No.
10/660,286, filed on Sep. 11, 2003; Drug Delivery System and
Method, Ser. No. 10/660,201, filed Sep. 11, 2003; and Battery
Backup Method and System, Ser. No. 10/660,285, filed Sep. 11, 2003,
all of which are incorporated herein by reference in their
entirety.
FIELD OF THE INVENTION
[0003] The present invention is related generally to medical
systems and components, which can be used in medical systems, and
more particularly to a medical effector system, such as a sedation
delivery system, and components, which can be used therein.
BACKGROUND OF THE INVENTION
[0004] A conscious sedation system is known and described in U.S.
Pat. No. 6,745,764 entitled "Apparatus and method for providing a
conscious patient relief from pain and anxiety associated with
medical or surgical procedures". In that system, a procedure room
unit included a controller, which generated a request for a
predetermined response from a patient. The request was in the form
of an auditory command, which was received by a patient through an
earphone in the ear of the patient or was in the form of a
vibration signal, which was received by the patient through a
vibrator in a handpiece, which was attached to the hand of the
patient. The predetermined response to the request was the pushing
of a button on the handpiece by the patient, which closed a switch
sending a signal to the controller. The controller analyzed medical
information from the patient. Such medical information included,
for example, blood pressure from a blood pressure cuff attached to
the procedure room unit and placed on the arm of the patient and
respiratory carbon dioxide levels obtained from a cannula (which
also delivered oxygen to the patient) attached to the procedure
room unit and placed on the face of the patient. The controller
also analyzed the time delay between the request and the response.
Based on the medical information and the time delay between the
request and the response, the controller determined the level of
sedation of the patient and decreased the flow of a gaseous or IV
(intravenous) conscious sedation drug to the patient if the
controller determined the patient was in a deeper level of
conscious sedation than desired.
[0005] It is known to deliver IV sedation drugs to a patient from a
drug-delivery cassette assembly using a peristaltic pump wherein
the cassette assembly and pump are attached to the procedure room
unit.
[0006] Still, scientists and engineers continue to seek improved
medical effector systems, such as sedation delivery systems, and
components, which can be used therein.
SUMMARY OF THE INVENTION
[0007] Various embodiments of the invention include a cannula
assembly, a bite block, a drug-delivery cassette assembly (which is
used in a drug-delivery infusion pump assembly which is a type of
drug-delivery flow control assembly which is an example of a
drug-delivery medical effector), an energy-delivery medical
effector, a procedure room unit, an interface between a procedure
room unit and a bedside monitoring unit, a bedside monitoring unit,
and components thereof, which can be used separately and in various
combinations including in a medical effector system such as a
sedation delivery system.
[0008] This invention is directed toward use in a minimal sedation,
moderate "conscious" sedation or deep sedation procedure, but not
to an anesthesia or "general anesthesia" application as defined by
the American Society of Anesthesiologists (ASA) in the document
"Continuum of Depth of Sedation: Definition of General Anesthesia
and Levels of Sedation/Analgesia, approved by the ASA house of
delegates on Oct. 13, 1999, and amended on Oct. 27, 2004. The ASA
defines general anesthesia as a drug-induced loss of consciousness
during which patients are not arousable, even by painful
stimulation. Further, patients often require assistance in
maintaining a patient airway, and positive pressure ventilation may
be required because of depressed spontaneous ventilation or
drug-induced depression of neuromuscular function, cardiovascular
function may be impaired.
[0009] In short, this invention provides a means for a procedural
physician outside the practice of anesthesiology to provide
sedation and/or pain relief to patients. The automation provided by
the invention compensates for lack of clear standards of practice
for non-anesthetists to guide the relief of pain and anxiety for
conscious patients. Moreover, the invention will subsidize the
limited training available to procedural physicians in the
diagnosis and treatment of complications that may arise or result
from the provision of sedation and analgesia to conscious
patients.
BRIEF DESCRIPTION OF THE FIGURES
[0010] FIG. 1 is a perspective view of an embodiment of a cannula
assembly of the invention, including the cannula, BMU-connector and
tubes and of an embodiment of an earpiece and an audio tube;
[0011] FIGS. 2 and 3 are cross-sectional views of tubing, taken
along lines 2-2 and 3-3 of FIG. 1, showing separate lumens that
conduct gases to/from the oral/nasal cannula;
[0012] FIG. 4 is a perspective view of the oral/nasal cannula of
FIG. 1 without any connecting tubes;
[0013] FIG. 5 is a cross-sectional view taken along lines 5-5 in
FIG. 4 of a portion of the cannula cap and cannula body showing the
bending of a respiratory-gas-sampling nasal prong of the cannula
body because of the location of the tube-receiving hole of a
respiratory-gas-delivery nasal prong of the cannula cap when the
cannula cap is attached to the cannula body;
[0014] FIG. 6 is a block diagram identifying elements of an
embodiment of an oral/nasal cannula assembly, including the
oral/nasal cannula of FIG. 1, and identifying elements of an
embodiment of a medical gas analysis/delivery system of an
embodiment of an SDS (sedation delivery system), which is an
example of a medical effector system, including an embodiment of a
PRU (procedure room unit) and an embodiment of a BMU (bedside
monitoring unit);
[0015] FIG. 7 is a top planar view of the oral/nasal cannula of
FIG. 4 with the cannula cap removed;
[0016] FIGS. 8 and 9 are cross-sectional views of the oral/nasal
cannula of FIG. 7, taken along lines 8-8 and 9-9 of FIG. 7,
indicating paths for oxygen and CO.sub.2 gases;
[0017] FIG. 10 is a distal end view of the oral/nasal cannula BMU
connector of FIG. 1 without any connecting tubes;
[0018] FIG. 11 is a cross-sectional view of the oral/nasal cannula
BMU connector of FIG. 10, taken along lines 11-11 in FIG. 10,
showing the recess for the nasal moisture chamber;
[0019] FIG. 12 is an enlarged view of a portion of the oral/nasal
cannula BMU connector of FIG. 11 showing details of CO.sub.2 gas
lines;
[0020] FIG. 13 is an exploded view of the oral/nasal cannula
connector of FIG. 10 showing the outlet cover, gasket and back
plate;
[0021] FIG. 14 is a schematic, side-elevational, cross-sectional
view of the nasal moisture trap chamber of FIG. 13;
[0022] FIG. 15 is proximal connecting-end view of the back plate of
the oral/nasal cannula connector of FIG. 13 identifying individual
ports;
[0023] FIG. 16 is a proximal end view of the outlet cover of the
oral/nasal cannula of FIG. 13;
[0024] FIGS. 17 and 18 are cross-sectional views of the outlet
cover of FIG. 16, taken along lines 17-17 and 18-18 of FIG. 16,
indicating paths for gases and moisture chamber details;
[0025] FIG. 19 is a front elevational view of a first embodiment of
a bite block and a portion of a first alternate embodiment of a
cannula;
[0026] FIG. 20 is a cross-sectional view of the bite block of FIG.
19 taken along the lines 20-20 of FIG. 19 with the addition of a
medical instrument inserted in the through passageway of the bite
block;
[0027] FIG. 21 is a view, as in FIG. 20 but of a second embodiment
of a bite block;
[0028] FIG. 22 is a view, as in FIG. 20 but of a third embodiment
of a bite block;
[0029] FIG. 23 is a schematic diagram of a further embodiment of a
medical effector system having a cannula, wherein the medical
effector system alerts a user of a possible problem with the
cannula;
[0030] FIG. 24 is a top perspective view of an embodiment of a
drug-delivery cassette assembly of the invention;
[0031] FIG. 25 is a bottom perspective view of the drug-delivery
cassette assembly of FIG. 24;
[0032] FIG. 26 is an exploded view of the drug-delivery cassette
assembly of FIG. 24 showing individual components;
[0033] FIG. 27 is a perspective view of the luer-site base portion
(also called a T-site base area when the luer is "T"-shaped) of the
drug-delivery cassette assembly of FIG. 26;
[0034] FIG. 28 is a perspective view of the spike bed area of the
drug-delivery cassette assembly of FIG. 26;
[0035] FIG. 29 is a top planar view of the drug-delivery-cassette
main board of the drug-delivery cassette assembly of FIG. 26;
[0036] FIGS. 30 and 31 are cross-sectional views of the
drug-delivery-cassette main board of FIG. 29, taken along lines
30-30 and 31-31 in FIG. 29, showing the vial sensor beam and the
T-site sensor beam;
[0037] FIG. 32 is a perspective view of the spike of the
drug-delivery cassette assembly of FIG. 26;
[0038] FIG. 33 is an end view of the spike of FIG. 32;
[0039] FIG. 34 is a cross-sectional view (which has been rotated
ninety degrees counterclockwise) of the spike of FIG. 33 taken
along lines 34-34 of FIG. 33;
[0040] FIGS. 35 and 36 are a right-side and left-side perspective
views of the spike cap of the drug-delivery cassette assembly of
FIG. 26 showing details of the cap handle and latching system;
[0041] FIG. 37 is a side elevational view of the spike cap of the
drug-delivery cassette assembly of FIG. 26;
[0042] FIG. 38 is an end elevational view of the spike cap of the
drug-delivery cassette assembly of FIG. 26;
[0043] FIG. 39 is a top planar view of the spike cap of the
drug-delivery cassette assembly of FIG. 26;
[0044] FIG. 40 is a cross-sectional view of the spike cap of FIG.
39, taken along lines 40-40 in FIG. 39, showing the spike
hollow;
[0045] FIG. 41 is a perspective view of the sedation delivery
system (SDS) of FIG. 6, which is an example of a medical effector
system, including the procedure room unit (PRU), the bedside
monitoring unit (BMU), and the umbilical cable;
[0046] FIG. 42 is a front perspective view of the SDS cart and the
PRU of FIG. 41 including the universal power supply (UPS) of the
PRU;
[0047] FIG. 43 is a top perspective view of the PRU of FIG. 41 with
an installed drug-delivery cassette assembly and with the
pump-housing door closed;
[0048] FIG. 44 is a top perspective view of a portion of the PRU of
FIG. 43 with the pump-housing door open and with an uninstalled
drug-delivery cassette assembly;
[0049] FIG. 45 is a top perspective view of a portion of the PRU of
FIG. 43 with an installed drug-delivery cassette assembly and with
the pump-housing door open;
[0050] FIG. 46 is a top perspective view of a portion of the PRU of
FIG. 43 with an installed drug-delivery cassette assembly, with the
pump-housing door closed, and with an about-to-be-installed drug
vial;
[0051] FIG. 47 is a top perspective view of a portion of the PRU of
FIG. 43 with an installed drug-delivery cassette assembly, with the
pump-housing door closed, and with an installed drug vial;
[0052] FIG. 48 is an exploded view of the PRU of FIG. 43;
[0053] FIG. 49 is a rear perspective view of a portion of the PRU
of FIG. 43;
[0054] FIG. 50 is a front perspective view of the oxygen-delivery
manifold seen installed in the rear of the PRU in FIG. 49;
[0055] FIG. 51 is a rear perspective view of the oxygen-delivery
manifold of FIG. 50;
[0056] FIG. 52 is a cross-sectional view of the oxygen-delivery
manifold of FIG. 51 taken along arrows 52-52 in FIG. 51;
[0057] FIG. 53 is an enlarged view of a portion of the
oxygen-delivery manifold of FIG. 52;
[0058] FIG. 54 is a top perspective view of the PRU host controller
of the PRU of FIG. 43;
[0059] FIG. 55 is an exploded view of the drug-delivery infusion
pump assembly of the PRU of FIG. 43;
[0060] FIG. 56 is a rear perspective view of the UPS of FIG.
42;
[0061] FIG. 57 is an exploded view of the UPS of FIG. 42;
[0062] FIG. 58 is a schematic view of an alternate embodiment of a
medical effector system of the invention including an
energy-delivery medical effector;
[0063] FIG. 59 is a schematic diagram of an embodiment of a medical
effector subsystem having a drug-delivery infusion pump
subassembly, wherein the medical effector subsystem alerts a user
of an occluded drug-delivery tube;
[0064] FIG. 60 is a front perspective view of the BMU of FIG. 41
with connecting lines attached;
[0065] FIG. 61 is a bottom perspective view of the BMU of FIG. 41
with connecting lines detached;
[0066] FIG. 62 is an exploded view of the BMU of FIG. 41;
[0067] FIG. 63 is a block diagram identifying elements of an
embodiment of a sedation delivery system (SDS);
[0068] FIG. 64 is a block diagram identifying elements of an
embodiment of a procedure room unit (PRU) for use in an SDS of FIG.
63;
[0069] FIG. 65 is a block diagram identifying elements of a system
board for use with a PRU of FIG. 64;
[0070] FIG. 66 is a block diagram of a drug delivery module for use
with a PRU of FIG. 64;
[0071] FIG. 67 is a block diagram of an oxygen delivery module for
use with a PRU of FIG. 64;
[0072] FIG. 68 is a block diagram of a power board module for use
with a PRU of FIG. 64;
[0073] FIG. 69 is a block diagram of a printer module for use with
a PRU of FIG. 64;
[0074] FIG. 70 is a block diagram of an uninterruptible power
supply (UPS) for use with a PRU of FIG. 64;
[0075] FIG. 71 is a block diagram of a UPS module for use with a
UPS of FIG. 70;
[0076] FIG. 72 is a block diagram of a bedside monitoring unit
(BMU) for use with an SDS of FIG. 63;
[0077] FIG. 73 is a block diagram of a BMU expansion board for use
with a BMU of FIG. 72;
[0078] FIG. 74 is a block diagram of a display assembly for use
with an SDS of FIG. 63;
[0079] FIG. 75 is a block diagram of single-patient-use (SPU) items
for use with an SDS of FIG. 63;
[0080] FIG. 76 is a block diagram of multiple-patient-use (MPU)
items for use with an SDS of FIG. 63;
[0081] FIG. 77 is diagrammatical process flow of the BMU and PRU of
an SDS of FIG. 63 during one example of a surgical procedure;
[0082] FIG. 78 is an overview data-flow diagram depicting the
pre-medical procedure aspect of an SDS of FIG. 63;
[0083] FIG. 79 is an overview data-flow diagram depicting the
medical procedure aspect of an SDS of FIG. 63; and
[0084] FIG. 80 is an overview data-flow diagram depicting the
post-medical procedure aspect of an SDS of FIG. 63.
[0085] FIG. 81 is a front perspective of the peripheral monitor
used in conjunction with the PRU.
DETAILED DESCRIPTION OF THE INVENTION
[0086] Before explaining the present invention in detail, it should
be noted that the invention is not limited in its application or
use to the details of construction and arrangement of parts and
steps illustrated in the accompanying drawings and description. The
illustrative embodiments of the invention may be implemented or
incorporated in other embodiments, variations and modifications,
and may be practiced or carried out in various ways. Furthermore,
unless otherwise indicated, the terms and expressions employed
herein have been chosen for the purpose of describing the
illustrative embodiments of the present invention for the
convenience of the reader and are not for the purpose of limiting
the invention.
[0087] A medical effector is a device adapted to deliver at least
one medical substance and/or at least one type of medical energy
locally and/or generally to a patient during a medical procedure. A
medical procedure includes, without limitation, a medical
diagnostic procedure, a medical therapy procedure, and/or a
surgical procedure. A medical substance is at least one gas,
liquid, and/or solid having alone and/or together a medical effect
on a patient, and an example is a pharmaceutical drug. Medical
energy is energy having a medical effect on a patient. An example,
without limitation, of a medical effect is a sedative effect. The
terminology "sedative effect" includes conscious sedation and
unconscious (anesthetic) sedation depending on the type and/or
amount of the medical substance and/or medical energy being used.
For purposes of describing the embodiments of the invention, an
analgesic effect is considered to be a sedative effect, and an
amnestic effect is considered to be a sedative effect. An example,
without limitation, of a medical substance having a sedative effect
is the sedation drug Propofol. An example, without limitation, of a
medical effector for delivering Propofol to a patient is a
drug-delivery flow control assembly such as a drug-delivery
infusion pump assembly. An example, without limitation, of a type
of medical energy having a sedative effect is a time-varying
magnetic field as described in U.S. Pat. No. 6,712,753. An example,
without limitation, of a medical effector for delivering a
time-varying magnetic field to a patient is at least one magnetic
flux generator as described in U.S. Pat. No. 6,712,753. Thus, a
sedation delivery system employing a sedation-drug-delivery flow
control assembly and a sedation delivery system employing at least
one magnetic flux generator are examples of sedation medical
effector systems. Other examples of medical effector systems,
medical effectors, medical substances, drugs, types of medical
energy, medical effects, and medical procedures are left to the
artisan. It is noted that the hereinafter-used terms "attachable",
"attached", "connectable", and "connected" include, respectively,
directly or indirectly attachable, directly or indirectly attached,
directly or indirectly connectable, and directly or indirectly
connected. It is further noted that describing an apparatus as
having a particular component means that the apparatus has at least
one such particular component. Likewise, describing a component as
having a particular feature means that the component has at least
one such particular feature.
[0088] Various aspects and embodiments of the invention are
hereinafter described, for ease of understanding, with reference to
a sedation delivery system 100 and a sedation drug-delivery flow
control assembly 220', but it is understood that such aspects and
embodiments have equal application with reference to other examples
of medical effector systems 100' than a sedation delivery system
100 and/or to other examples of medical effectors 220'' than a
drug-delivery flow control assembly 220'. Such other examples
include, without limitation, a medical effector system including a
non-sedation drug-delivery flow control assembly and a medical
effector system including at least one magnetic flux generator.
[0089] It is further understood that any one or more of the
following-described aspects, embodiments, expressions of
embodiments, examples, etc. can be combined with any one or more of
the other following-described aspects, embodiments, expressions of
embodiments, examples, etc.
[0090] Cannula Assembly
[0091] A first aspect of the invention is directed to, or a
component of, or can be used by, a cannula assembly 145, an
embodiment of which is shown in FIGS. 1-18. A first expression of
the embodiment of FIGS. 1-18 is for a cannula assembly 145
including an oral-nasal cannula 351 and a slidable tube 371'. The
oral-nasal cannula 351 is disposable on the face of a patient 10
and includes a respiratory-gas-sampling nasal prong 364 or 365 and
a respiratory-gas-sampling oral prong 369'. The slidable tube 371'
is slidably connected to one of the respiratory-gas-sampling nasal
and oral prongs 364, 365 or 369' to accommodate different distances
between the nose and mouth of different patients 10. In one
example, the slidable tube 371' is slidably connected to the
respiratory-gas-sampling oral prong 369', wherein the slidable tube
371' has a substantially right-angle bend and a distal end 14, and
wherein, when the oral-nasal cannula 351 is disposed on the face of
the patient 10, the distal end 14 of the slidable tube 371' extends
distally toward or into the mouth of the patient 10. Other examples
are left to the artisan.
[0092] A second expression of the embodiment of FIGS. 1-18 is for a
cannula assembly 145 including a cannula 351' (such as, but not
limited to, an oral-nasal cannula 351) and a user-detachable oral
prong extension 370' or 370''. The cannula 351' is disposable on
the face of a patient 10 and includes a respiratory-gas-sampling or
respiratory-gas-delivery oral prong 369'/371' or 369''/371'' having
an opening. The user-detachable oral prong extension 370' or 370''
comes removably attached to the oral prong 369'/371' or 369''/371''
and is user-connectable to the opening of the oral prong 369'/371'
or 369''/371''. In one example of the second expression of the
embodiment of FIGS. 1-18, the oral prong 369' or 369'' lacks the
slidable prong 371' or 371'', and in another example it does not.
In one implementation of the second expression, the oral prong
extension 370' or 370'' is connected to the opening of the oral
prong when the user is employing a bite block (not shown) with the
patient such as during esophageal procedures requiring an
endoscope. In one illustration, the user-detachable oral prong
extension 370' or 370'' is manually detached by the user without
the use of any tool. In one construction, the oral prong extension
370' or 370'' comes removably attached to the oral prong 369'/371'
or 369''/371'' by a manually-breakable tether 12. Alternate
constructions include removable attachment by use of score lines or
perforations. Other examples, implementations, and constructions
are left to the artisan.
[0093] A third expression of the embodiment of FIGS. 1-18 is for a
cannula assembly 145 comprising a cannula 351' which is disposable
on the face of a patient 10 and which includes a
respiratory-gas-sampling oral prong 369'/371' having a distal end
14 and a respiratory-gas-delivery oral prong 369''/371'' having a
distal end 16 wherein, when the cannula 351' is disposed on the
face of the patient 10, the distal end 14 of the
respiratory-gas-sampling oral prong 369'/371' extends distally
further toward or into the mouth of the patient 10 than the distal
end 16 of the respiratory-gas-delivery oral prong 369''/371''. In
one example of the third expression of the embodiment of FIGS.
1-18, the respiratory-gas-sampling oral prong 369'/371' is a
carbon-dioxide respiratory-gas-sampling oral prong, and the
respiratory-gas-delivery oral prong 369''/371'' is used to deliver
air with an enriched oxygen content (sometimes just referred to as
"oxygen") to the patient 10. In this example, such staggering of
the distal ends 14 and 16 of the two prongs 369'/371' and
369''/371'' reduces oxygen dilution of the carbon-dioxide sample,
as can be appreciated by those skilled in the art. Other examples
are left to the artisan.
[0094] A fourth expression of the embodiment of FIGS. 1-18 is for a
cannula assembly 145 comprising a cannula 351' which is disposable
on the face of a patient 10 and which includes left and right
cannula support wings 367' and 367'' each having a wing tip portion
with an adhesive pad 366 removably adhesively attachable to a side
of the face of the patient 10. In one example, no other attachment
is used to secure the cannula 351' to the face of the patient 10.
In this example, the adhesive pad 366 provides for a more
convenient cannula attachment for the patient than a conventional
headband, etc. Other examples are left to the artisan.
[0095] A fifth expression of the embodiment of FIGS. 1-18 is for a
cannula assembly 145 comprising a cannula 351' which is disposable
on the face of a patient 10, which includes a cannula body 18
having a respiratory-gas-sampling nasal prong 364 or 365, and which
includes a cannula cap 368 having a respiratory-gas-delivery nasal
prong 422 with a tube-receiving hole 26. The cannula cap 368 is
attached to the cannula body 18 with the respiratory-gas-sampling
nasal prong 364 or 365 passing through and extending beyond the
tube-receiving hole 26. The tube-receiving hole 26 is disposed to
bend the respiratory-gas-sampling nasal prong 364 or 365 toward the
nose of the patient 10 when the cannula 351' is disposed on the
face of the patient 10. This arrangement allows for better
respiratory gas sample acquisition as can be appreciated by those
skilled in the art. In one example of the fifth expression of the
embodiment of FIGS. 1-18, the nasal prong 364 or 365 is
substantially straight before the cannula cap 368 is attached to
the cannula body 18.
[0096] A sixth expression of the embodiment of FIGS. 1-18 is for a
cannula assembly 145 comprising a cannula 351' which is disposable
on the face of a patient 10 and which includes a
respiratory-gas-sampling nasal prong 364 or 365 having a distal end
20 and a respiratory-gas-delivery nasal prong 422' or 422'' having
a distal end 22, wherein, when the cannula 351' is disposed on the
face of the patient 10, the distal end 20 of the
respiratory-gas-sampling nasal prong 364 or 365 extends distally
further toward or into one of the nostrils of the patient 10 than
the distal end 22 of the respiratory-gas-delivery nasal prong 422'
or 422''. Such staggering of the distal ends 20 and 22 of the two
prongs 364 or 365 and 422' or 422'' reduces respiratory delivered
gas dilution of the respiratory gas sample, as can be appreciated
by those skilled in the art. In one example of the sixth expression
of the embodiment of FIGS. 1-18, the respiratory-gas-sampling nasal
prong 364 or 365 is circumferentially surrounded by the
respiratory-gas-delivery nasal prong 422' or 422''. Other examples
are left to the artisan.
[0097] A seventh expression of the embodiment of FIGS. 1-18 is for
a cannula assembly 145 including an oral-nasal cannula 351 and a
connector 363. The oral-nasal cannula 351 is disposable on the face
of a patient 10 and includes a left-nostril
respiratory-gas-sampling tube 354, a right-nostril
respiratory-gas-sampling tube 352, and an oral
respiratory-gas-sampling tube 355. The connector 363 includes a
cover 394 and a back plate 423 attached to the cover 394. The cover
394 includes an interior nasal moisture trap chamber 412 and an
interior oral moisture trap chamber 411 isolated from the interior
nasal moisture trap chamber 412. The back plate 423 includes a
nasal capnometry port 402 and an oral capnometry port 400. The left
and right nostril respiratory-gas-sampling tubes 354 and 352 are
connected to the cover 394 and are in fluid communication with the
interior nasal moisture trap chamber 412. The oral
respiratory-gas-sampling tube 355 is connected to the cover 394 and
is in fluid communication with the interior oral moisture trap
chamber 411. The nasal capnometry port 402 is in fluid
communication with the interior nasal moisture trap chamber 412.
The oral capnometry port 400 is in fluid communication with the
interior oral moisture trap chamber 411.
[0098] In one example of the seventh expression of the embodiment
of FIGS. 1-18, the connector 363 also includes a hydrophobic filter
395' disposed between the interior nasal moisture trap chamber 412
and the nasal capnometry port 402 and a hydrophobic filter 395''
disposed between the interior oral moisture trap chamber 411 and
the oral capnometry port 400. In another example, not shown, a
desiccant is disposed in the nasal and oral moisture trap chambers
412 and 411. Other examples are left to the artisan.
[0099] In one variation of the seventh expression of the embodiment
of FIGS. 1-18, the connector 363 also includes an
inter-flow-path-sealing gasket 396 disposed between the interior
nasal and oral moisture trap chambers 412 and 411 and the nasal
capnometry and oral capnometry ports 402 and 400. The gasket 396
includes annular towers 24 which extend into the nasal capnometry
and oral capnometry ports 402 and 400 and provide, at least in
part, the fluid communication between the interior nasal moisture
trap chamber 412 and the nasal capnometry port 402 and between the
oral moisture trap chamber 411 and the oral capnometry port
400.
[0100] An eighth expression of the embodiment of FIGS. 1-18 is for
a cannula assembly 145 including a cannula 351' and a connector
363. The cannula 351' is disposable on the face of a patient 10 and
includes a respiratory-gas-sampling tube 354, 352 or 355. The
connector 363 includes a cover 394, a back plate 423, and a gasket
396. The back plate 423 is attached to the cover 394. The cover 394
includes an interior moisture trap chamber 412 or 411. The back
plate 423 includes a capnometry port 402 or 400. The
respiratory-gas-sampling tube 354, 352 or 355 is connected to the
cover 394 and is in fluid communication with the interior moisture
trap chamber 412 or 411, and the capnometry port 402 or 400 is in
fluid communication with the interior moisture trap chamber 412 or
411. The gasket 396 is disposed between the interior moisture trap
chamber 412 or 411 and the capnometry port 402 or 400. The gasket
396 includes an annular tower 24 which extends into the capnometry
port 402 or 400 and provides, at least in part, the fluid
communication between the interior moisture trap chamber 412 or 411
and the capnometry port 402 or 400.
[0101] A ninth expression of the embodiment of FIGS. 1-18 is for a
cannula-assembly connector 363. The cannula-assembly connector 363
includes at least one cannula-assembly connector member together
having a nasal capnometry port 402, an oral capnometry port 400, a
nasal pressure port 401, and a respiratory-gas-delivery port 399.
Each of the ports 402, 400, 401 and 399 is fluidly-connectable to a
bedside monitoring unit (BMU) 300 (an embodiment of which is seen
in FIGS. 6 and 60-62) of a sedation delivery system (SDS) 100 (or
other type of medical effector system 100'). The terminology
"fluidly-connectable" includes directly fluidly-connectable and
indirectly fluidly-connectable.
[0102] In one example of the ninth expression of the embodiment of
FIGS. 1-18, the at-least-one cannula-assembly connector member
consists of a plate (e.g., back plate 423). In the same or a
different example, each of the ports 402, 400, 401 and 399 has a
center and the distance between the centers of any two ports 402,
400, 401 and 399 is shortest for the nasal capnometry and nasal
pressure ports 402 and 401. In one extension of the ninth
expression, the at-least-one cannula-assembly connector member
together have an audio port 398. In one construction, the connector
363 includes a back plate 423, wherein one or more or all of the
ports 402, 400, 401 and 399 (and, when present, 398) are ports of
the back plate 423. In one variation, the back plate 423 includes
adapter pins 397 for aligning and/or assisting in connecting the
ports 402, 400, 401 and 399 (and, when present, 398) to the BMU
300. In one modification, the back plate 423 is configured as shown
in FIGS. 13 and 15. In another construction, not shown, the
connector 363 lacks a plate or a back plate. In one arrangement,
the BMU 300 has ports, which enter the ports 402, 400, 401 and 399
(and, when present, 398) of the connector 363 to provide the fluid
connection. In another arrangement, the ports 402, 400, 401 and 399
(and, when present, 398) of the connector 363 enter ports on the
BMU 300 to provide the fluid connection. Other arrangements
(including connector ports which are flush with the back plate, not
shown) providing the fluid connection of the connector ports and
the BMU are left to the artisan.
[0103] In one implementation of the ninth expression of the
embodiment of FIGS. 1-18, the bedside monitoring unit (BMU) 300 is
fluidly-connectable to a procedure room unit (PRU) 200 (an
embodiment of which is shown in FIGS. 6 and 41-57) of the sedation
delivery system (SDS) 100 (or other type of medical effector system
100'). The procedure room unit 200 includes an oral capnometer 202
and a nasal capnometer 140 (see FIG. 54). When the oral and nasal
capnometry ports 400 and 402 of the connector 363 are fluidly
connected to the bedside monitoring unit 300 and the bedside
monitoring unit 300 is fluidly connected to the procedure room unit
200, the oral capnometer 202 is in fluid communication with the
oral capnometry port 400 and the nasal capnometer 140 is in fluid
communication with the nasal capnometry port 402. The terminology
"fluidly connected" includes directly fluidly connected and
indirectly fluidly connected.
[0104] A tenth expression of the embodiment of FIGS. 1-18 is for a
cannula water-trap subassembly 28 including a cannula water-trap
housing 30 and a hydrophobic filter 395. The cannula water-trap
housing 30 includes a moisture trap chamber 411 or 412 having a
moisture-collection cavity 32 and a sampled-respiratory-gas
pass-through cavity 34. The sampled-respiratory-gas pass-through
cavity 34 is disposed higher than, and in fluid communication with,
the moisture-collection cavity 32. The sampled-respiratory-gas
pass-through cavity 34 has a smaller volume than the
moisture-collection cavity 32. The sampled-respiratory-gas
pass-through cavity 34 has a sampled-respiratory-gas entrance and a
sampled-respiratory-gas exit. The hydrophobic filter 395 is
disposed to cover the exit of the sampled-respiratory-gas
pass-through cavity 34. All sampled respiratory gas 36 entering the
sampled-respiratory-gas pass-through cavity 34 must pass through
the hydrophobic filter 395 to exit the sampled-respiratory-gas
pass-through cavity 34. Moisture in the sampled respiratory gas 36
collects in the moisture-collection cavity 32.
[0105] An eleventh expression of the embodiment of FIGS. 1-18 is
for a cannula assembly 145 including a cannula 351', a connector
363, and an audio earpiece 362. The cannula 351' is disposable on
the face of a patient 10 and includes a respiratory-gas-sampling
tube 354, 352 or 355. The respiratory-gas-sampling tube 354, 352 or
355 is fluidly-connected to the connector 363, and the connector
363 is connectable to a bedside monitoring unit 300 of a sedation
delivery system 100 (or other type of medical effector system
100'). The audio earpiece 362 is disposable proximate an ear of the
patient 10 and is operatively-connected to the connector 363 to
give sound to the patient 10 at least at the direction of the
bedside monitoring unit 300 when the connector 363 is connected to
the bedside monitoring unit 300 and the audio earpiece 362 is
disposed proximate the ear of the patient 10. The term "proximate"
includes, without limitation, "in" and "on".
[0106] In one example of the eleventh expression of the embodiment
of FIGS. 1-18, the audio earpiece 362 is disposable in the ear of
the patient 10, and the cannula assembly 145 includes an audio
(i.e., sound) tube 356 which is operatively-connected to the audio
earpiece 362 and to the connector 363 and which acoustically
transmits sound from a speaker in the bedside monitoring unit (BMU)
300 to the audio earpiece 362 when the connector 363 is connected
to the BMU 300. In one employment, the BMU 300 uses the audio
earpiece 362 to provide the patient 10, while in the pre-procedure
room, with training commands to squeeze an automated response
monitor (e.g., a handpiece) to establish a patient response time
while conscious. In one variation, a training computer program in
the BMU 300 controls the speaker during such training. Thereafter,
the patient 10, while in the procedure room undergoing sedation, is
provided operational commands to squeeze the automated response
monitor at the request of a procedure room unit (PRU) 200 of the
sedation delivery system 100 (or other type of medical effector
system 100'). The PRU 200 uses at least the patient response time
to determine a level of consciousness of the patient 10 undergoing
sedation (or other type of medical procedure). In one variation, a
computer program in the PRU 200 controls the speaker during patient
sedation. In another employment, soothing sounds, such as music,
are given to the patient in the pre-procedure room by the audio
earpiece 362. In a different example, the audio earpiece 362 is a
speaker on a headset and the audio tube 356 is replaced by electric
wiring. Other examples are left to the artisan.
[0107] In one application of any of the above-described expressions
of FIGS. 1-18, including examples, etc. thereof, the cannula
assembly 145 is directly connectable to the Bedside Monitoring Unit
(BMU) 300. For example, in one application of the seventh
expression of the embodiment of FIGS. 1-18, the connector 363 is
directly connectable to the Bedside Monitoring Unit (BMU) 300,
wherein inlet ports of the BMU 300 enter the annular towers 24 of
the gasket 396 and compress the annular towers 24 against the
corresponding nasal capnometry and oral capnometry ports 402 and
400 to provide a leak-free seal. In a different application of any
of the above-described expressions of FIGS. 1-18, including
examples, etc. thereof, the cannula assembly 145 is directly
connectable to a unit (not shown) that stays in the procedure room.
For example, in a different application of the seventh expression
of the embodiment of FIGS. 1-18, the connector 363 is directly
connectable to a unit (not shown) that stays in the procedure room.
In one variation, the unit (not shown) includes delivery of a
sedation drug(s) to the patient 10, and in another variation, the
unit (not shown) does not include delivery of a sedation drug(s) to
the patient. Other applications are left to the artisan.
[0108] Any one or more of the above-described expressions of the
embodiment of FIGS. 1-18, including examples, etc. thereof can be
combined with any other one or more of the above-described
expressions of the embodiment of FIGS. 1-18, including examples,
etc. thereof, as can be appreciated by those skilled in the
art.
[0109] FIGS. 19 and 20 show a first embodiment of a bite block 74,
which, in one example, is used with the cannula assembly 145 of
FIGS. 1-18. A bite block, in one example, is used on a patient
during an upper-gastrointestinal endoscopic medical procedure. The
bite block has a bite-block body, which is inserted into the mouth
of the patient. The bite-block body has a through passageway for
insertion of an endoscope therethrough. The patient bites down on
the bite-block body instead of on the endoscope.
[0110] A first expression of the embodiment of FIGS. 19 and 20 is
for a bite block 74 including a bite-block body 76 adapted for
insertion into the mouth of a patient. The bite-block body 76
includes a through passageway 78 and includes an air sampling
passageway 80 spaced apart from the through passageway 78. The
through passageway 78 is adapted for receiving therethrough a
medical instrument 82 (only an unhatched portion of which is shown
in FIG. 20). The air sampling passageway 80 has an inlet 84
disposed to receive exhaled air from the patient when the
bite-block body 76 is inserted into the mouth of the patient. The
air sampling passageway 80 has an outlet 86 adapted for coupling to
a respiratory gas sampling port 88 of a cannula 90 (only the
body/cap portion of an embodiment of an oral/nasal cannula without
respiratory-gas-delivery prongs is shown). In one variation, the
outlet 86 of the air sampling passageway 80 is adapted for
indirectly coupling to the respiratory gas sampling port 88 of the
cannula 90 through a connector tube 92.
[0111] A second expression of the embodiment of FIGS. 19 and 20 is
for a cannula assembly 94 including a cannula 90, a bite block 74,
and a connector tube 92. The cannula 90 is disposable on the face
of a patient and includes a respiratory gas sampling port 88. The
bite block 74 has a bite-block body 76 adapted for insertion into
the mouth of a patient. The bite-block body 76 includes a through
passageway 78 and includes an air sampling passageway 80 spaced
apart from the through passageway 78. The through passageway 78 is
adapted for receiving therethrough a medical instrument 82. The air
sampling passageway 80 has an inlet 84 disposed to receive exhaled
air from the patient when the bite-block body 76 is inserted into
the mouth of the patient and has an outlet 86. The connector tube
92 having a first end attached or attachable to the respiratory gas
sampling port 88 of the cannula 90 and has a second end attached or
attachable to the bite-block body 76 at the outlet 86 of the air
sampling passageway 80 of the bite-block body 76.
[0112] FIG. 21 shows a second embodiment of a bite block. An
expression of the embodiment of FIG. 21 is for a bite block
assembly 96 including a bite-block body 98 and an air sampling tube
102. The bite-block body 98 is adapted for insertion into the mouth
of a patient and includes a through passageway 104 adapted for
receiving therethrough a medical instrument 106 (only a portion of
which is shown). The air sampling tube 102 is attached to the
bite-block body 98, has an inlet 108 disposed to receive exhaled
air from the patient when the bite-block body 98 is inserted into
the mouth of the patient and has an outlet 112 attached or
attachable to a respiratory gas sampling port of a cannula.
[0113] In one variation of the embodiment of FIG. 21, the air
sampling tube 102 is at least partially disposed within the through
passageway 104. In one construction, the air sampling tube 102 is
adhesively attached to the bite-block body 98. In one employment,
the outlet 112 of the air sampling tube 102 is adapted for indirect
attachment to the respiratory gas sampling port of the cannula
through a connector tube 118.
[0114] FIG. 22 shows a third embodiment of a bite block. An
expression of the embodiment of FIG. 22 is for a bite block
assembly 122 including a bite-block body 124 and an air sampling
tube 126. The bite-block body 124 is adapted for insertion into the
mouth of a patient. The bite-block body 124 includes a through
passageway 128 adapted for receiving therethrough a medical
instrument 132 (only a portion of which is shown) and includes an
air sampling passageway 134. The air sampling tube 126 is at least
partially disposed within the air sampling passageway 134, has an
inlet 136 disposed to receive exhaled air from the patient when the
bite-block body 124 is inserted into the mouth of the patient, and
has an outlet 138 attached or attachable to a respiratory gas
sampling port of a cannula. In one variation, the outlet 138 of the
air sampling tube 126 is adapted for indirect attachment to the
respiratory gas sampling port of the cannula through a connector
tube 148.
[0115] Examples of the embodiments of FIGS. 19 and 20, 21, and 22
have the advantage of maintaining the air sampling passageway/tube
in proper air-sampling position despite movement of the instrument
in the through passageway during a medical procedure. This results
in more accurate carbon dioxide gas concentration measurements of
the exhaled air of the patient than is achieved with conventional
bite block and cannula arrangements which employ a cannula having
an air sampling tube which does not stay in position relative to
the bite block.
[0116] FIG. 23 shows a further embodiment of a medical effector
system 154, wherein the medical effector system 154 alerts a user
of a possible problem with a cannula 156 of the medical effector
system 154. An expression of the embodiment of FIG. 23 is for a
medical effector system 154 including a pressure sensor 158, a
cannula 156, and a memory 166. The pressure sensor 158 includes an
input 168 and has an output signal 170. The cannula 156 is
disposable on the face of a patient and includes a
respiratory-gas-sampling tube 172 operatively connectable to the
input 168 of the pressure sensor 158. The memory 166 contains a
cannula program which when running on a processor 174 is
operatively connected to the output signal 170 of the pressure
sensor 158. The cannula program alerts a user of a possible problem
with the cannula 156 based at least in part (and in one example
based entirely) on the output signal 170 of the pressure sensor
158. It is noted that, in one example, the input 168 of the
pressure sensor 158 is for receiving a pneumatic signal in the form
of respiratory gas from the patient.
[0117] In one deployment of the embodiment of FIG. 23, when the
cannula 156 is disposed on the face of the patient and when the
respiratory-gas-sampling tube 172 is operatively connected to the
input 168 of the pressure sensor 158, the output signal 170 of the
pressure sensor 158 corresponds to the pressure generated by the
patient's breathing which is a time varying signal corresponding to
the breath rate of the patient. If no cannula 156 is disposed on
the face of the patient and/or if the respiratory-gas-sampling tube
172 of the cannula 156 is not operatively connected to the input
168 of the pressure sensor 158, then the output signal 170 (which
typically is an electrical signal) of the pressure sensor 158 would
substantially equal that of atmospheric pressure.
[0118] In one construction of the embodiment of FIG. 23, the
respiratory-gas-sampling tube 172 is adapted to sample respiratory
gas from at least one of the mouth, left nostril and right nostril
of the patient. In one variation, not shown, the
respiratory-gas-sampling tube is adapted to sample respiratory gas
from the mouth and both nostrils of the patient. In another
variation, not shown, the respiratory-gas-sampling tube is adapted
to sample respiratory gas from just both nostrils of the patient.
In an additional variation, the respiratory-gas-sampling tube 172
is adapted to sample respiratory gas from just one of the left
nostril, right nostril, and mouth of the patient.
[0119] In one employment of the embodiment of FIG. 23, the possible
cannula problem includes the cannula 156 not being disposed (or not
being disposed properly) on the face of the patient when the
cannula program is running on the processor 174. In the same or a
different employment, the possible cannula problem includes the
cannula 156 not being operatively connected to the input 168 of the
pressure sensor 158 when the cannula program is running on the
processor 174.
[0120] In one application of the embodiment of FIG. 23, the
pressure sensor 158 is a component of a bedside monitoring unit
(e.g., the bedside monitoring unit 300 of FIG. 6 wherein pressure
sensor 158 would replace nasal pressure transducer 47). In the same
or a different application, the memory 166 and the processor 174
are components of a host controller of a procedure room unit (such
as host controller 204 of the procedure room unit 200 of FIG. 6).
In one variation, the medical effector system 154 also includes an
umbilical cable (such as the umbilical cable 160 of FIG. 6). In
this variation, the cannula program automatically starts running
after the bedside monitoring unit and the procedure room unit are
operatively connected together with the umbilical cable when at
least one of the bedside monitoring unit and the procedure room
unit has been turned on. In one employment, the possible problem
with the cannula includes the umbilical cable not being connected
(or not being properly connected) to the bedside monitoring unit
and the procedure room unit. In one modification, the procedure
room unit includes a capnometer 230 and 234 operatively connectable
to the cannula 156, and the cannula program starts the capnometer
230 and 234 if the cannula program does not alert the user of the
possible problem with the cannula 156. In another application, the
pressure sensor 158, the memory 166, the processor 174, and the
capnometer 230 and 234 are components of a single unit.
[0121] In one arrangement of the embodiment of FIG. 23, the
respiratory-gas-sampling tube 172 is an oral respiratory-gas
sampling tube 236, the cannula 156 also includes a left-nostril
respiratory-gas-sampling tube 238 operatively connectable to the
input 168 of the pressure sensor 158, and the cannula 156
additionally includes a right-nostril respiratory-gas-sampling tube
240 operatively connectable to the input 168 of the pressure sensor
158. In one variation, at least one valve 242, 244 and 246 is
controllable by the cannula program to selectively operatively
connect to the pressure sensor 158, one at a time, the oral,
left-nostril and right-nostril respiratory-gas-sampling tubes 236,
238 and 240. Other configurations using a different number of
valves, different valve design, and/or different valve connections
than that shown in FIG. 23 are left to the artisan. In one
modification, the medical effector system 154 also includes at
least one capnometer 230 and 234, wherein the at-least-one valve
242, 244 and 246 is controllable by the cannula program to
operatively connect the oral, left-nostril and right-nostril
respiratory-gas-sampling tubes 236, 238 and 240 to the at-least-one
capnometer 230 and 234. In one application, the at least one
capnometer 230 and 234 includes a nasal capnometer 230 which
receives respiratory-gas-sampling input from both nostrils of the
patient and an oral capnometer 234 which receives
respiratory-gas-sampling input from the mouth of the patient. In
one implementation, the nasal capnometer 230 and the oral
capnometer 234 are components of a procedure room unit (such as the
previously-discussed procedure room unit 200). It is noted that the
connections between the processor 174 and the capnometers 230 and
234 and between the processor 174 and the at-least-one valve 242,
244 and 246 have been omitted from FIG. 23 for clarity. In other
arrangements, not shown, two or three pressure sensors are
employed.
[0122] In other configurations, not shown, of a medical effector
system which alerts a user of a possible problem with a cannula,
each valve 242, 244 and 246 (which in one example also has an off
position blocking any flow from exiting the valve) of FIG. 23 is
replaced with a splitter which divides the associated
respiratory-gas-sampling tube into one branch connected to the
associated capnometer and another branch connected to the pressure
sensor. In one variation, one, two or three pressure sensors and/or
one, two or three capnometers are employed. It is noted that, in
one deployment, the strongest pressure signal from a breathing site
identifies the best breathing site for use in capnometer
measurements of carbon dioxide in the exhaled breath of the
patient.
[0123] In one example, benefits of the medical effector system 154
include automatically alerting the user of a possible problem with
the cannula 156 without employing less reliable mechanical switches
and include providing baseline pressure measurements for a
patient's oral breathing and nasal breathing. Such baseline
pressure measurements, in one application, are used to later
determine if a patient's preferred breathing orifice has changed
whereupon the flow rate of oxygen to the patient undergoing a
medical procedure is raised or lowered.
[0124] The following paragraphs present a detailed description of
one particular enablement of the embodiment of FIGS. 1-18. It is
noted that any feature(s) of this particular enablement can be
added to any of the previously-described expressions (including
examples, etc. thereof) of the embodiment of FIGS. 1-18. In this
particular enablement, the cannula assembly 145 is an oxygen (the
term "oxygen" includes air with an enriched oxygen content)
delivery cannula assembly, more specifically a cannula assembly 145
(shown in FIG. 1) that supplies oxygen to a patient 10 and collects
oral and nasal exhaled breath samples for analysis. The oral/nasal
cannula 351 allows for measurement of end-tidal CO.sub.2 gas (the
term "CO.sub.2 gas" means gas containing CO.sub.2) from both oral
and nasal cavities, as well as measurement of CO.sub.2 gas pressure
from combined nasal cavities.
[0125] Oral/nasal cannula 351 provides a stream of oxygen directed
into the oral and nasal cavities, unlike prior art cannulas, which
provide oxygen as a cloud to the exterior of the oral or nasal
cavities. Cannula assembly 145 includes a nasal pressure sensor
line that provides a signal to an oxygen controller to decrease
oxygen flow rates during exhalation thus preventing dilution of the
end-tidal gas sample, increasing measurement accuracy. Cannula 145
allows for independent oral and nasal capnometry measurement,
different from prior art capnometry cannulas, which combine the
sampling to come up with an average measurement. The invention also
includes a connector 363 as an integral part of the cannula system
to facilitate easy attachment and removal from Bedside Monitoring
Unit (BMU) 300. Cannula 145 also provides for the delivery of
audible commands to a patient 10 requesting a response for an
Automated Responsiveness Monitor (ARM).
[0126] In one construction, oral nasal cannula 351 is made of a
soft pliable material that is easily deformable and will fit
comfortably on a patient's 10 face. This ensures patient 10 comfort
and minimize irritation.
[0127] Cannula assembly 145 (shown in FIG. 1) is part of an
integrated monitoring and sedation delivery system (SDS) intended
to provide a safe means to administer sedation drug in surgical
procedures. The system uses a drug delivery algorithm and an
intravenous infusion peristaltic pump to deliver drug(s) with
variable rate infusion that achieves and maintains a desired
sedation effect. All drug delivery is performed by a Procedure Room
Unit (PRU) 200, which together with a Bedside Monitoring Unit (BMU)
300 enables the care team to make necessary drug dosing changes
possible from any location.
[0128] As used herein, the term "proximal" refers to a location on
the oral/nasal cannula assembly closest to the device using the
cannula assembly and thus furthest from the patient 10 on which the
cannula assembly is used. Conversely, the term "distal" refers to a
location farthest from the device using the cannula assembly and
closest to the patient 10.
[0129] As illustrated on FIGS. 1-3, oral/nasal cannula 351 is
designed to fit comfortably upon the upper lip of a patient 10
between the nose and mouth. Oral/nasal cannula 351 functions as a
mask-free delivery apparatus for supplying oxygen gas to a patient
10 while also providing for the monitoring of patient 10 breathing.
Oral/nasal cannula 351 is connected to a set of tubing for gas
sample collection, audio and oxygen delivery, and includes cinch
361 to help secure to the patient 10, an earpiece 362 to allow
audio messages to be sent to the patient 10, and BMU connector 363
for secure connection to the bedside monitoring unit (BMU) 300.
[0130] Referring to FIGS. 1 and 6, the cannula assembly 145
includes distal oral-nasal cannula 351 earpiece 362 and proximal
connector 363. Exhalation samples from the patient 10 are collected
by oral-nasal cannula 351 and flow through independent channels and
lumens to connector 363. Connector 363 is removably attached to
bedside monitoring unit (BMU) 300. Gases (oxygen and CO.sub.2) are
then routed via the umbilical to/from procedure room unit (PRU)
200. The capnometry system includes two capnometers in PRU 200. A
particle and hydrophobic filter are located inside cannula
connector 363. Oral chamber 411 and nasal chamber 412 are designed
to trap condensation from the patient's 10 exhaled breath to avoid
moisture damage to the capnometers. A nasal pressure transducer 47
is located in the bedside monitoring unit (BMU) 300. The pressure
transducer 47 provides patient 10 breathing information to
procedure room unit (PRU) 200 through the umbilical cable.
[0131] As shown in FIG. 4, oral-nasal piece 351 is made of soft and
flexible material, such as polyurethane, silicon or some other
elastomer, and is generally constructed by either injection-molding
or liquid injection molding techniques. Cannula cap 368 is
generally a hollow cube and is the platform for supporting other
features. Oral-nasal piece 351 profile is designed to easily adapt
to patient 10 anatomy. Oral-nasal cannula 351 includes adhesive
pads 366 located on the patient 10 side of cannula wings 367 and
are intended to adhere to and secure comfortably oral-nasal piece
351 in place on the patient 10's face. Cannula cap 368 includes
nasal prong 422 and oral prong 369. Cannula body 18 includes nasal
prongs 364 and 365 and oral prongs 370 and 371.
[0132] FIGS. 4 and 6-9 illustrate that cannula cap 368 includes two
independent gas circuits, one for collecting oral and nasal exhaled
CO.sub.2 for capnometry and pressure analysis, and a second for
supplying oxygen into the patient's 10 nose and mouth. FIG. 8 shows
a cross-section view of the oral/nasal cannula 351 CO.sub.2
sampling circuit. The CO.sub.2 sampling circuit comprises a left
and right nostril circuit and oral sample circuit, which are
internally molded and interconnected inside cannula cap 368.
CO.sub.2 left circuit is comprised of left prong channel 375 and
left channel 377, interconnected at right angles, and functioning
to collect CO.sub.2 samples from the patient's 10 left nostril.
Left sample tube 354 (FIG. 1) is inserted into and fixedly attached
to left channel 377, which divides the CO.sub.2 sampling volume
into two lumens (shown on FIGS. 2-3 and 6): left pressure lumen 359
and left sample lumen 360. In addition, CO.sub.2 right circuit is
comprised of right prong channel 374 and right channel 376,
interconnected at right angles, and functioning to collect CO.sub.2
samples from the patient 10's right nostril. Right sample tube 352
(FIG. 1) is inserted into and fixedly attached to right channel
376, which divides the CO.sub.2 sampling volume into two lumens
(shown on FIGS. 2-3 and 6): right pressure lumen 357 and right
sample lumen 358. The arrangement is essentially the same for an
oral circuit which comprises an oral prong channel 379 within oral
prongs 369, 371 and 370; and an oral channel 378 inside cannula cap
368. Oral prong channel 379 and oral channel 378 are interconnected
and collect CO.sub.2 samples from the patient 10's mouth.
[0133] As illustrated in FIGS. 7-9, a second gas circuit delivers
oxygen in the proximity of the patient's 10 nose and mouth. FIG. 9
shows a cross-section view of oral/nasal cannula 351. Oxygen
channel 387 is in fluid communication with chamber 384 within
cannula cap 368. Oxygen chamber 384 has three openings: a first
opening connecting to oxygen prong channel 381, which delivers
oxygen in the vicinity of the mouth; a second opening which
communicates with right channel 385 that delivers oxygen into the
right nostril; and a third opening which delivers oxygen to the
left nostril through channel 386.
[0134] As shown on FIG. 4, nasal oxygen prongs 422 are mounted over
prongs 364 and 365. Prongs 422 have a tapered shape and fit
co-axial around nasal prongs 364 and 365. Prongs 422 include a
number of holes to permit oxygen passage from within cannula cap
368 to the vicinity of the patient's 10 nostrils.
[0135] The oral system is comprised of oral prongs 369 which are an
integral part of oral-nasal cannula 351, sliding prongs 371 which
are slidably mounted over prongs 369, and EGD
(esophageo-gastro-duodenoscopy) prong extension 370. The oral prong
system consists of two independent channels: oxygen prong channel
381 for oxygen supply; and oral prong channel 379 for CO.sub.2
sample collection. Sliding prongs 371 are slidably mounted over
prongs 369 forming an "L" shape and allow for flexibility in
adapting to different patients 10. Prongs 369 are extendable and
retractable to be easily positioned in front of the mouth. A third
piece comprising the oral prong system are detachable/attachable
prong extension EGD (esophageo-gastro-duodenoscopy) prongs 370,
which are designed to mount slidably on sliding prongs 371 to reach
inside the patient's 10 mouth. EGD prong extension 370 is
manufactured tethered to prongs 371 but is easily detached by the
user. EGD extension 370 improves the delivery and collection of
gases into the mouth, but can be easily removed and discarded if
not used.
[0136] As shown on FIG. 1, the tubing set is comprised of two
extruded tubes 352 and 354 for transporting CO.sub.2 nasal samples,
each tube set containing two small lumens, tube 355 for
transporting the CO.sub.2 oral sample, audio tube 356, and oxygen
tube 353 to transport oxygen into chamber 384 (shown in FIGS. 7-9).
The tubes are commercially available and preferably constructed of
pliable plastic material such as extruded polyvinyl chloride. Each
extruded tube 352 and 354 transports CO.sub.2 samples from right
and left nostrils, respectively. Sample tube 352 is connected to
cannula cap 368 adjacent oxygen tube 353 on the right side. In a
similar arrangement sample tube 354 is connected to cannula cap 368
adjacent oral sample tube 355 on the left side.
[0137] Now referring to FIGS. 2 and 3, right pressure lumen 357 and
right sample lumen 358 are located within tube 352 and transport
CO.sub.2 gas samples from the right nostril for pneumatic and
capnometry analysis. In the same form, left pressure lumen 359 and
left sample lumen 360 are located within tube 354 to transport
CO.sub.2 gas samples from the left nostril. In one arrangement,
tube 352 is adhered to oxygen tube 353, and in the same manner,
tube 354 is adhered to oral sample tube 355. The connection between
tubes is designed such that the tubes can be easily separated as
needed. A separate audio tube 356 is attached to earpiece 362 and
is used to transport sound to the patient 10's ear.
[0138] As illustrated on FIG. 13, oral/nasal cannula connector 363
is comprised of four components which when assembled together form
internal chambers and channels. The components are outlet cover
394, hydrophobic filter 395, gasket 396, and back plate 423. The
components are held together by internal latches 403 which are
snapped and locked onto internal notches 404.
[0139] Referring to FIGS. 10-13 and 15-18, outlet cover 394 and
back plate 423 are made of molded rigid thermoplastic, while gasket
396 is made of an elastic, flexible material. Included in outlet
cover 394 are moisture chambers 411 and 412 used for trapping
moisture from oral and nasal CO.sub.2 sampling gases. Outlet cover
394 includes gripper snaps 388 to facilitate the user securely
attaching the connector assembly to the BMU interface connector
(shown on FIG. 1). Left and right nasal CO.sub.2 gases are combined
in recess 415 after passing through capnometry outlet channels 417
(shown on FIGS. 16-18). The nasal capnometry analysis is performed
on the combined gas sample in PRU 200 (see FIG. 6). Pressure
analysis is also made on a combined gas sample after CO.sub.2 gases
pass through pressure lines 424 (FIG. 12).
[0140] Oral capnometry analysis is performed on a CO.sub.2 gas
sample, which is taken after gas has passed through oral outlet
channel 416 and into oral recess 410 and moisture chamber 411 (see
FIG. 6). Recesses 410 and 415 hold hydrophobic filter 395 which
traps moisture and allows it to drain into moisture chambers 411
and 412, preventing moisture damage to other sensitive parts of the
capnometry system.
[0141] Referring to FIGS. 1 and 10-13, the distal face of outlet
cover 394 provides connectors for all cannula tubing. The distal
face of cover 394 includes oxygen tube opening 390, which is the
connection point for tube 353, audio tube opening 389 which is the
connection point for tube 356, right tube opening 392 which
receives sample tube 352, left tube opening 393 connecting to
sample tube 354, and oral tube opening 391 which receives oral
sample tube 355. All connection points are designed to create a
leak tight seal with the mating tubing. Both right and left nasal
CO.sub.2 pressure lines 418 (see FIG. 16) connect to pressure lumen
ports 421 located in recess 420.
[0142] As best illustrated on FIGS. 13 and 15, gasket 396 is
sandwiched between outlet cover 394 and back plate 423. Its
function is to create internal channels and to isolate individual
flow paths. It also secures hydrophobic filter 395. Hydrophobic
filter 395 is also held by filter notch 419 and bumps 413 located
on outlet cover 394 proximal face. Hydrophobic filter 395 is
commercially available and has the properties of being
particle-blocking and hydrophobic. Back plate 423 includes a number
of ports that interface with the connector on BMU 300 (FIG. 1)
including audio port 398, oxygen port 399, oral port 400, and
pressure port 401. Adaptor pins 397 function to guide the
connection between cannula connector 363 and the connector on BMU
300.
[0143] It is noted that in the detailed description of the one
particular enablement of the embodiment of FIGS. 1-18, the cannula
351', the connector 363, and the earpiece 362 are
single-patient-use (SPU) items.
[0144] Drug-Delivery Cassette Assembly
[0145] A second aspect of the invention is directed to, or a
component of, or can be used by, a drug-delivery cassette assembly
251, an embodiment of which is shown in FIGS. 24-40 and which, in
one enablement is used in an embodiment of a procedure room unit
(PRU) 200 shown in FIGS. 41-57. A first expression of the
embodiment of FIGS. 24-40 is for a drug-delivery cassette assembly
251 including a luer 269, tubing 277 and 259 and a
drug-delivery-cassette main board 253. The tubing 277 and 259 has a
drug-receiving end, which is fluidly-connectable to a drug vial 250
containing a drug, and has a drug-delivery end, which is
fluidly-connected to the luer 269. The terminology
"fluidly-connectable" includes directly fluidly-connectable and
indirectly fluidly-connectable, and the terminology
"fluidly-connected" includes directly fluidly-connected and
indirectly fluidly-connected. The cassette main board 253 has a
luer-site base portion 271. The luer 269 is attachable to and
detachable from the luer-site base portion 271. The luer-site base
portion 271 has a deflectable luer-site sensor beam 275 which is
disposed to be deflected by the luer 269 when the luer 269 is
attached to the luer-site base portion 271 and to be undeflected
when the luer 259 is detached from the luer-site base portion 271.
The luer-site base portion 271 is also referred to, in one
construction, as a T-site base 271, and the luer-site sensor beam
275 is also referred to, in that one construction, as a T-site
sensor beam 275. Other constructions are left to the artisan.
[0146] In one example of the first expression of the embodiment of
FIGS. 24-40, the cassette main board 253 is attachable to and
detachable from a procedure room unit (PRU) 200 (shown in FIGS.
41-57) having a luer-in-place optical sensor 226 (see FIG. 44)
disposed to sense only one of the deflected luer-site sensor beam
275 and the undeflected luer-site sensor beam 275. In one
variation, the procedure room unit 200 controls flow of the drug in
the tubing 277 and 259 to air purge the tubing 277 and 259 and to
deliver the drug through the tubing to a patient based at least in
part on the luer-in-place optical sensor 226 sensing or not sensing
the luer-site sensor beam 275. Other examples are left to the
artisan.
[0147] A broad description of a combination of the second aspect of
the invention (a drug-delivery cassette assembly embodiment of
which is shown in FIGS. 24-40) and a later-discussed third aspect
of the invention (a procedure room unit embodiment of which is
shown in FIGS. 41-57) is for a drug-delivery assembly (e.g.,
drug-delivery cassette assembly 251 and procedure room unit 200).
In one expression of the combination, the drug-delivery assembly
(e.g., 251 and 200) includes tubing (e.g., 277 and 259), a storage
site (e.g., luer-site base portion 271), a pump (e.g., 220 as seen
in FIG. 41), and a sensor (e.g., luer-in-place optical sensor 226,
as seen in FIG. 44). The tubing (e.g., 277 and 259) has a
drug-receiving end that is fluidly-connectable to a drug vial
(e.g., 250) containing a drug and has a drug-delivery end portion
(e.g., luer 269). The storage site (e.g., 271) is adapted for
releasably storing the drug-delivery end portion (e.g., 269) of the
tubing (e.g., 277 and 259) when the drug-delivery end portion of
the tubing is not in drug-delivering communication with a patient.
The pump (e.g., 220) controls flow of the drug in the tubing (e.g.,
277 and 259), when the tubing (e.g., 277 and 259) is operatively
connected to the pump (e.g., 220), to air purge the tubing (e.g.,
277 and 259) and to deliver the drug through the tubing (e.g., 277
and 259) to the patient. The sensor (e.g., 226) has an output and
is disposed to sense the presence and/or absence of the
drug-delivery end portion (e.g., 269) of the tubing (e.g., 277 and
259) in the storage site (e.g., 271).
[0148] It is noted that, in one example of the broadly-described
combination, the drug-delivery end portion of the tubing has a
length of substantially one to four inches and includes any end
fitting (e.g., luer 269) attached to the drug-delivery end portion
of the tubing (e.g., 277 and 259) itself. In one application, the
sensor directly senses the presence and/or absence of the
drug-delivery end portion (e.g., 269) of the tubing (e.g., 277 and
259) in the storage site (e.g., 271). In another application, the
sensor (e.g., 226) indirectly senses the presence and/or absence of
the drug-delivery end portion (e.g., 269) of the tubing (e.g., 277
and 259) by sensing the presence and/or absence of another
component (e.g., the luer-site sensor beam 275) which changes
position between the presence and absence of the drug-delivery end
portion (e.g., 269) of the tubing (e.g., 277 and 259) in the
storage site (e.g., 271). It is understood that the recited
components are not limited to the particular component examples
found in parentheses following the components. Thus, other examples
of a sensor can be used such as, without limitation, another
optical sensor, an ultrasonic sensor, a proximity sensor, or an
electromagnetic sensor. Likewise, other examples of a storage site,
etc. can be used, and the drug-delivery system is not limited to
requiring a drug-delivery cassette assembly and/or a procedure room
unit, as can be appreciated by the artisan.
[0149] In one implementation of the drug-delivery assembly (e.g.,
251 and 200), the pump (e.g., 220) air purges the tubing (e.g., 277
and 259) only when the drug-delivery end portion (e.g., 269) of the
tubing (e.g., 277 and 259) is stored in the storage site (e.g.,
271) as determined from the output of the sensor (e.g., 226). This
helps prevent inadvertent priming (i.e., air purging) of the tubing
(e.g., 277 and 259) when the drug-delivery end portion (e.g., 269)
of the tubing (e.g., 277 and 259) is in fluid communication with
the patient.
[0150] In the same or a different implementation of the
drug-delivery assembly (e.g., 251 and 200), the tubing (e.g., 277
and 259) is operatively disconnectable from the pump (e.g., 220)
only when the drug-delivery end portion (e.g., 269) of the tubing
(e.g., 277 and 259) is stored in the storage site (e.g., 271) as
determined from the output of the sensor (e.g., 226). This helps
prevent free flow of the drug into the patient or the environment.
In one variation, a pump-housing door (e.g., 201) pinches the
operatively connected tubing (e.g., 277 and 259) against the pump
(e.g., 220) so that pump action is required for drug flow and drug
flow is shut off (i.e., there is no free flow) when the pump (e.g.,
220) is not pumping. In this variation, the pump-housing door
(e.g., 201) is locked and cannot be opened to remove the pinched
tubing (e.g., 277 and 259) unless the drug-delivery end portion
(e.g., 269) of the tubing (e.g., 277 and 259) is stored in the
storage site (e.g., 271) as determined from the output of the
sensor (e.g., 226).
[0151] A second expression of the embodiment of FIGS. 24-40 is for
a drug-delivery cassette assembly 251 including a
drug-delivery-cassette main board 253. A drug vial 250 is
attachable to the cassette main board 253. The cassette main board
253 has a deflectable drug-vial-site sensor beam 267 which is
disposed to be deflected by the drug vial 250 when the drug vial
250 is attached to the cassette main board 253 and to be
undeflected when the drug vial 250 is unattached to the cassette
main board 253. The drug-vial-site sensor beam 267 is also referred
to, in one construction, as a spike sensor beam 267. Other
constructions are left to the artisan.
[0152] In one example of the second expression of the embodiment of
FIGS. 24-40, the cassette main board 253 is attachable to and
detachable from a procedure room unit (PRU) 200 (shown in FIGS.
41-57) having a drug-vial-in-place optical sensor 228 (see FIG. 44)
disposed to sense only one of the deflected drug-vial-site sensor
beam 267 and the undeflected drug-vial-site sensor beam 267. In one
variation, the procedure room unit 200 controls flow of the drug
from the drug vial 250 based at least in part on the
drug-vial-in-place optical sensor 228 sensing or not sensing the
drug-vial-site sensor beam 267.
[0153] In the same or a different example of the second expression
of the embodiment of FIGS. 24-40, the drug vial 250 includes a
drug-vial seal 42, and the drug-delivery cassette assembly 251 also
includes a spike 261 having a spike tip 296 and a spike barb 184.
When the drug vial 250 is attached to the cassette main board 253,
the drug-vial seal 42 is perforated by the spike tip 296 and held
by the spike barb 184 and the drug-vial-site sensor beam 267 pushes
the drug vial 250 up against the spike barb 184. Such pushing up
reduces drug wastage, as can be appreciated by those skilled in the
art. Other examples are left to the artisan.
[0154] A third expression of the embodiment of FIGS. 24-40 is for a
drug-delivery cassette assembly 251 including a
drug-delivery-cassette spike 261. A drug vial 250 is attachable to
the spike 261. The drug vial 250 includes a drug-vial seal 42. The
spike 261 has a spike tip 296 and a spike barb 184. When the drug
vial 250 is attached to the spike 261, the drug-vial seal 42 is
perforated by the spike tip 296 and held by the spike barb 184.
[0155] A fourth expression of the embodiment of FIGS. 24-40 is for
a drug-delivery cassette assembly 251 including a luer 269, a
drug-delivery-cassette spike 261, tubing 277 and 259, and a
drug-delivery-cassette main board 253. The spike 261 includes a
drug-vial-seal-perforating spike tip 296. The tubing 277 and 259
has a drug-receiving end, which is fluidly-connectable to and
fluidly-disconnectable from the spike 261 and has a drug-delivery
end, which is fluidly-connected to the luer 269. The spike 261 is
attachable to and detachable from the cassette main board 253. This
allows just the spike 261 to be disposed in a sharps container
reducing overall sharps-waste volume and disposal fees, as can be
appreciated by those skilled in the art.
[0156] A fifth expression of the embodiment of FIGS. 24-40 is for a
drug-delivery cassette assembly 251 including a luer 269, tubing
277 and 259, and a drug-delivery-cassette main board 253. The
tubing 277 and 259 has a drug-receiving end, which is
fluidly-connectable to a drug vial 250 containing a drug, and has a
drug-delivery end, which is fluidly-connected to the luer 269. The
cassette main board 253 has a luer-site base portion 271. The luer
269 is attachable to and detachable from the luer-site base portion
271. The luer-site base portion 271 has a drip chamber 273 disposed
to collect any of the drug, which exits the luer 269 when the luer
269 is attached to the luer-site base portion 271. The luer-site
base portion 271 is also referred to, in one construction, as a
T-site base 271. Other constructions are left to the artisan. In
one example of the fifth expression of the embodiment of FIGS.
24-40, the drug-delivery cassette assembly 251 also includes a
drug-absorbent pad 273' disposed in the drip chamber 273. Other
examples are left to the artisan.
[0157] A sixth expression of the embodiment of FIGS. 24-40 is for a
drug-delivery cassette assembly 251 including a luer 269 and tubing
277 and 259. The tubing 277 and 259 includes a coiled tube 259 and
a flexible tube 277 fluidly-connected together. The flexible tube
277 has a drug-receiving end, which is fluidly-connectable to a
drug vial 250 containing a drug, and the coiled tube 259 has a
drug-delivery end, which is fluidly-connected to the luer 269. The
coiled tube 259 is extendible by the user. In one example of the
sixth expression of the embodiment of FIGS. 24-40, the coiled tube
250 includes a plurality of coils wherein adjacent coils are
releasably adhered together. This arrangement allows the user to
pull out only the length of coiled tube 259 needed for use with a
patient thus providing for improved tubing management. In one
variation, adjacent coils are thermally tacked together. In another
variation, irradiation during sterilization releasably adheres
together adjacent coils of the coiled tube 259. In the same or a
different example, the coiled tube 259 has a smaller inside
diameter than the flexible tube 277. This reduces drug wastage
remaining in the tubing 277 and 259 after its use and expedites
removal of air during an initial purge. Other examples are left to
the artisan.
[0158] A seventh expression of the embodiment of FIGS. 24-40 is for
a drug-delivery cassette assembly 251 including a
drug-delivery-cassette main board 253 which is removably attachable
to a procedure room unit 200 of a sedation delivery system 100 (or
other type of medical effector system 100') and which includes a
peristaltic pump cutout 254. In one example, of the seventh
expression of the embodiment of FIGS. 24-40, the drug-delivery
cassette assembly 251 also includes a drug-delivery flexible tube
277 having a substantially linear portion attached to the main
board 253 and spanning the peristaltic pump cutout 254, wherein,
when the main board 253 is attached to the procedure room unit 200,
the portion of the flexible tube 277 is operatively connected to
pump fingers of a drug-delivery peristaltic pump of the procedure
room unit 200.
[0159] An eighth expression of the embodiment of FIGS. 24-40 is for
a drug-delivery cassette assembly 251 including a
drug-delivery-cassette main board 253. The main board 253 has a
top-left portion, a top-right portion, a bottom-right portion and a
bottom-left portion. The cassette main board 253 is removably
attachable to a procedure room unit 200 of a sedation delivery
system 100 (or other type of medical effector system 100'). The
main board 253 has a peristaltic pump cutout 254 disposed between
the top-left and top-right portions. The main board 253 has an
air-in-line sensor cutout 255 disposed between the top-right
portion and the bottom-right portion.
[0160] In one example of the eighth expression of the embodiment of
FIGS. 24-40, the drug-delivery cassette assembly 251 also includes
a drug-delivery flexible tube 277 having a substantially linear
first portion attached to the top-left portion and the top-right
portion of the main board 253 and spanning the peristaltic pump
cutout 254 and having a substantially linear second portion
attached to the top-right portion and the bottom-right portion of
the main board 253 and spanning the air-in-line sensor cutout 255.
When the main board 253 is attached to the procedure room unit 200,
the first portion of the flexible tube 277 is operatively connected
to pump fingers of a drug-delivery peristaltic pump of the
procedure room unit 200 and the second portion of the flexible tube
277 is operatively connected to an air-in-line sensor of the
procedure room unit 200.
[0161] In the same or a different example of the eighth expression
of the embodiment of FIGS. 24-40, the lower-left portion of the
main board 253 extends below the lower-right portion of the main
board 253 defining a pump-door-latch cutout extending to the right
of the lower-left portion and below the lower-right portion of the
main board 253.
[0162] In one application of any of the above-described expressions
of FIGS. 24-40, including examples, etc. thereof, the cassette main
board 253 is directly attachable to a procedure room unit (PRU) 200
(shown in FIGS. 41-57). Other applications are left to the
artisan.
[0163] Any one or more of the above-described expressions of the
embodiment of FIGS. 24-40, including examples, etc. thereof can be
combined with any other one or more of the above-described
expressions of the embodiment of FIGS. 24-40, including examples,
etc. thereof, as can be appreciated by those skilled in the
art.
[0164] The following paragraphs present a detailed description of
one particular enablement of the embodiment of FIGS. 24-40. It is
noted that any feature(s) of this particular enablement can be
added to any of the previously-described expressions (including
examples, etc. thereof) of the embodiment of FIGS. 24-40. In this
enablement, the drug-delivery cassette assembly 251 is used in
conjunction with a drug-delivery infusion pump assembly 220. In
this enablement, drug-delivery cassette assembly 251 is part of an
integrated patient monitoring and sedation delivery system (SDS)
100 (shown in FIG. 41) intended to administer sedation drug(s)
during brief procedures. The system uses a drug delivery algorithm
and an intravenous infusion peristaltic (or other type) pump 220
(see FIG. 41), together with the drug-delivery cassette assembly
251, to deliver drug(s) with variable rate infusion that achieves
and maintains a desired sedation effect.
[0165] As used herein, the term "proximal" refers to a location on
the drug-delivery cassette assembly 251 closest to the device using
the drug-delivery cassette assembly 251 and thus furthest from the
patient on which the drug-delivery cassette assembly 251 is used.
Conversely, the term "distal" refers to a location farthest from
the device using the drug-delivery cassette assembly 251 and
closest to the patient.
[0166] As shown in FIGS. 24-26, cassette 251 is comprised of a
cassette main board 253 which in one example is molded of rigid
thermoplastic having a generally flat rectangular shape, with
smooth rounded corners, and rectangular cutouts 254 and 255
designed to permit interface with a peristaltic pump 220 (see FIG.
41) and its sensor components (e.g., 226 and 228 as shown in FIG.
44). In one employment, cassette 251, including main board 253 and
components are single-patient-use components and are disposable.
Cassette main board 253 is comprised of a generally flat thin base
designed with molded features to support fluid communication tubes
277 and 259, reducer 281, spike system 272, and commercial luer
269. Spike system 272 includes spike cap 263, spike 261, air vent
filter 295, and spike elbow 265.
[0167] Again referring to FIGS. 24-26, cassette main board 253 has
a top face 252 and a bottom face 260, which hold secure components
assembled to cassette 251. Cassette main board 253 has a
peristaltic pump cutout 254 on the proximal side. Air-in-line
sensor cutout 255 and a tube passage 258 are apertures generally
located on the sides of main board 253. A visible arrow sign 289 is
relief molded generally on the center of main board 253, and the
arrow tip indicates the insert direction of cassette 251 to the
user. Alignment hole 287 is a round aperture through main board 253
used to help the user position and align cassette 251 in the pump
220 (see FIG. 41).
[0168] As illustrated in FIGS. 24-26, in one construction cassette
main board 253 is comprised of one reinforcement rib 256 on top
face 252 and parallel reinforcement grooves 286 on bottom face 260
to increase stiffness of plastic molded structure 253 adjacent to
pump cutout 254 and air-in-line sensor cutout 255. Reinforcement
rib 256 and reinforcement grooves 286 help to make main board 253
rigid for handling and use purposes. Reinforcement rib 256 and
reinforcement grooves 286 are integrally molded as part of cassette
main board 253.
[0169] As shown in FIGS. 24 and 26, cassette main board 253 has:
(a) a coiled tube base 257 designed to hold coiled tube 259; (b) a
T-site base 271 to hold luer 269; and (c) a spike bed 262 to
accommodate spike system 272. Cassette main board 253 also includes
gripper handle 285.
[0170] As illustrated on FIG. 26, gripper handle 285 is an integral
part of cassette main board 253, extending from the distal side to
facilitate user handling. Gripper handle 285 is shaped with smooth
rounded corners to make it easy and comfortable to hold. Parallel
ribs 190 are molded on the top surface of gripper handle 285, which
function to give a firm non-slip surface for gripping firmly while
inserting or removing cassette 251 from the pump 220 (see FIG.
41).
[0171] As illustrated on FIGS. 24 and 26, the drug delivery system
mounted on cassette 251 is comprised of a set of flexible tubes
assembled in fluid communication. The tubing set includes (a) a
coiled tube 259 and (b) a flexible tube 277. The drug system also
is comprised of: (c) a reducer 281; (d) a spike system 272 mounted
to spike bed 262; and (e) a commercial luer 269 mounted on a T-site
base 271. In one construction, all pieces are removably mounted in
place for handling and transportation purposes.
[0172] As shown on FIGS. 25 and 26, tube 277 is made of transparent
flexible plastic, such as commercially available pvc, with constant
internal and external diameter cross section. Tube 277 is made of a
flexible resilient material to permit bending through passage 258
and to fit into clips 279. Tube 277 is generally assembled to
follow the cassette external contour. Cassette 251 utilizes clips
279 and track wall retainers 291 to guide and route tube 277,
generally keeping its cross-sectional diameter constant around the
corners of cassette 251 and through passage 258. In one
construction, not shown, the track wall retainers 291 are replaced
by one or more additional clips 279.
[0173] As illustrated on FIGS. 25 and 26, tube 277 is part of the
drug fluid communication system and connects at one end to (a)
spike elbow 265 and at the other end to (b) reducer 281. Tube 277
connects into spike elbow 265 on the bottom side of cassette 251.
Then tube 277 makes a turn into the transversal direction of
cassette 251, extending from cassette bottom side 260 through tube
passage 258. The opposite end of tube 277 is connected into reducer
281 on the top side of cassette 251. Tube 277 extends freely across
cutouts 254 and 255. Tube 277 crosses air-in-line cutout 255 and
peristaltic pump cutout 254.
[0174] As shown on FIGS. 24, 26 and 29, flexible tube 277 is held
in place by molded clips 279 located on cassette top face 252.
Clips 279 have alternating openings to keep tube 277 aligned and
secured in place without distortion. Clips 279 are generally curved
to match the outside diameter of tube 277. Clip openings 270 and
276 are the result of the manufacturing process that creates the
clips. Double clips 280 secure reducer 281 on cassette main board
253. In one construction, double clips 280 are built with only a
small clearance between them (as shown on FIG. 29) to attach firmly
to reducer 281 and anchor the tubing system. Clips 280 also have a
curved shape to match the outside contour of reducer 281 body.
Double clips 280 keep the two rings on the body of reducer 281
restrained in a fixed position, preventing sliding during handling
or use. The reducer 281 has a flat bottom, and the cassette main
board 253 has a reducer-positioning rib 40 (seen in FIG. 29 but
omitted from FIG. 26 for clarity), which also helps the reducer 281
stay in position when the reducer 281 is secured by double clips
280. In one example, tube 277 is kept firm and straight after
connection to a peristaltic pump 220, which is accomplished by
clips 280.
[0175] As illustrated on FIGS. 26 and 29, track wall retainers 291
are molded on cassette top face 252 to trap and keep constrained
tube 277 as it is routed around corners. The distance between walls
is such that it creates a slight interference with tube 277 helping
to retain tube 277. As previously mentioned, in one construction,
not shown, the track wall retainers 291 are replaced by one or more
additional clips 279.
[0176] As shown on FIG. 26, reducer 281 is part of the fluid
communication system, and is mounted onto the proximal part of
cassette 251. In one construction, it is made of transparent
thermoplastic material and comprises an inlet and outlet in fluid
communication, with the inlet and outlet at approximately right
angles to each other. The inlet end of reducer 281 is larger than
the outlet. The outlet end is adapted to be connected to IV
(intravenous) coiled tube 259 while the inlet end is adapted to
connect to flexible tube 277. Reducer 281 main body is generally
cylindrical shaped with two molded rings to mount onto clips 280 to
keep it fixed in place. Reducer 281 also helps secure smaller
diameter tubing assembly coiled tube 259 and larger diameter
flexible tube 277 in place.
[0177] As illustrated on FIGS. 26 and 27, coiled tube 259 is made
of transparent IV tubing, for example commercially available pvc,
manufactured and assembled to be biased into a generally
cylindrical spiral as a way to minimize overall size and to
facilitate handling and management by the user. In one
construction, coiled tube 259, when uncoiled and extended to its
maximum length, would total approximately 8 feet. This would be a
sufficient length for the user to extend coiled tube 259 between
cassette 251 and the patient. In one construction, coiled tube 259
is stored on cassette 251 in a half-cylindrical shape base 257
designed to prevent movement during cassette 251 shipping and
installation into the pump 220. One end of coiled tube 259 is
affixed to reducer 281 while the other end is connected to luer
269. In use, the clinician removes luer 269 from T-site bed 271,
disconnecting luer 269 from first luer clip 274 and second luer
clip 297, and pulls and uncoils tube 259 as far as necessary to
reach the patient. It should be noted that the inside fluid path of
tube 259 is minimized as compared with flexible tube 277 so as to
minimize wasted drug(s) remaining in the tubing after its use and
to expedite removal of air during an initial purge.
[0178] As shown on FIGS. 24, 27 and 29-31, T-site base 271 is
designed to removably capture luer 269. T-site base 271 also
includes a deflective built-in beam 275, which contacts luer 269
when luer 269 is fixed in place, causing beam 275 to deflect and
interface with an optical sensor 226 on the Procedure Room Unit
(PRU) 200 (shown in FIGS. 41-57). T-site base 271 further includes
open drip chamber 273 used as a reservoir to capture and contain
drug spillage during drug line purge. T-site base 271 has built-in
walls to create a sloped bed (as shown on FIG. 35) on cassette top
face 252. T-site base 271 has two molded-in clips. First luer clip
274 and second luer clip 297 firmly secure luer 269. T-site base
271 includes a thin tower 278. Luer 269 lays on top of T-site tower
278 at an inclined angle to direct excess drug spillage into
chamber 273.
[0179] As illustrated on FIGS. 27 and 29, drip chamber 273 is
integrally part of T-site base 271 and in one example is a molded
part of cassette main board 253. Drip chamber 273 is generally
located in a central area of cassette main board 253. Drip chamber
273 has a generally rectangular shape with one wall congruent to
T-site tower 278 and is sized to contain a specific volume of the
total drug vial 250 (see FIG. 32) content. Drip chamber 273
functions to prevent spillage during drug line purge and to capture
any residual drug after cassette use. In one variation, drip
chamber 273 contains an absorbent pad 273' to absorb all drained
drug(s).
[0180] As shown on FIGS. 25-27 and 29-31, T-site sensor beam 275 is
molded as an integral part of cassette main board 253 and acts as a
cantilever beam. The pivot point of beam 275 is built in the distal
side of cassette 251 on the top face of T-site tower 278. In one
construction, the free hanging end of beam 275 extends through
cassette bottom face 260 into a central longitudinal opening of
T-site base 262 (as shown on FIG. 31), which interfaces with
T-site-in-place optical sensor 226 located on the PRU 200. The free
hanging end of beam 275 is generally designed as a "T". One tip of
the "T" touches luer 269. When luer 269 is secured in base 271,
beam 275 deflects and the other T tip breaks the light beam of the
optical T-site-in-place sensor 226. This indicates to the PRU 200
(shown in FIGS. 41-57) that luer 269 is in place so that drug line
purge can be performed.
[0181] As illustrated on FIGS. 26 and 27, luer 269 is commercially
available and well known in the medical arts. It is made of rigid
plastic. In one construction, luer 269 is "T" shaped with an
internal lumen in fluid communication with all three legs of the
"T". One T-leg connects to coiled tube 259. Another "T" leg
contains a needleless port that can be attached to IV luer fitting.
The last "T" leg has a removable dust cap.
[0182] As shown on FIGS. 26, 28 and 32-34, spike bed 262 is a
recessed area molded into cassette main board 253 at a slight angle
so that when spike 261 is assembled to main board 253, spike 261 is
substantially vertically oriented when cassette 251 is placed into
the pump 220 in the PRU 200 (shown in FIGS. 41-57). The vertical
position of spike 261 helps the drug vial 250, when placed on spike
261, to drain properly and completely. Spike bed 262 has upright
walls to accommodate spike wing 197. Spike bed 262 bottom includes
two guiding pins 299 extending upwards and two apertures 292 to
help in aligning spike assembly 261. The center area of spike bed
262 has a half-cylindrical base 199 to accommodate air-vent boss
177. The air-vent boss base 199 generally creates a step on the
round contour to hold hollow spike 261 in place. In the center of
spike bed 262 bottom there is a round aperture for inserting spike
drug boss 185. In the longitudinal direction, in the middle of
spike bed 262, is the cutout of spike sensor beam 267, which has a
flat curved shape. Spike sensor beam 267 is fixed at the proximal
side of spike bed 262, and is a cantilever beam.
[0183] As shown on FIGS. 29-34, cantilever spike sensor beam 267
(shown on FIG. 30), is an integral part of cassette main board 253.
At the extreme end of spike beam 267 is lower spike tab 290, which
is positioned to interface with an optical vial-in-place sensor 228
located on the PRU 200 pump 220 (shown in FIG. 41). Upper spike tab
288 is a second tab located in an intermediate position along beam
267 and is positioned to interface with a drug vial 250 when a drug
vial 250 is placed on spike 261. Upper spike tab 288 extends
through aperture 198 on spike wing 197 when spike 261 is properly
assembled to cassette main board 253. When cassette assembly 251 is
in place in the pump 220 on the PRU 200 (shown in FIGS. 41-57) and
when a drug vial 250 is placed on spike 261, the vial makes contact
with upper spike tab 288 causing spike sensor beam 267 to deflect
sufficiently to cause lower spike tab 290 to interface with optical
vial-in-place sensor 228 located on the PRU 200. This indicates to
the PRU 200 that a drug vial 250 is properly in place so that drug
line purge can be performed and so that the PRU 200 pump 220 can
deliver drug(s) to the patient.
[0184] As shown on FIGS. 24, 26 and 32-34, spike system 272 is
comprised of spike cap 263, spike 261, and spike elbow 265. Spike
cap 263 helps protect clinicians from inadvertent sticks by spike
tip 296. Spike cap 263 is removably attached on top of spike tip
296 by a latching mechanism. Spike elbow 265 is removably threaded
(with a luer lock) onto drug boss 185. Spike elbow 265 securely
attaches spike 261 to cassette main board 253. Unthreading spike
elbow 265 from drug boss 185 allows spike 261 to be easily removed
from cassette main board 253 so that spike 261 can be properly
disposed in a sharps container, minimizing overall waste volume,
and saving disposal fees for the user.
[0185] As illustrated on FIGS. 32-34, spike 261 is molded of rigid
thermoplastic material and contains two internal lumens running
generally parallel the length of spike 261. Spike 261 is generally
cylindrical, having a perforating tip 296 and a spike wing 197 that
serves as a base to spike tip 296. Spike 261 includes spike barb
184 that will prevent a drug vial 250 from slipping off of spike
tip 296. Spike tip 296 includes a first bevel 186 and a second
bevel 187. First bevel 186 includes a drug opening, which is in
fluid communication with drug line lumen 195. Similarly, second
bevel 187 includes an air-vial opening, which is in airway
communication with air-vent lumen 196. In use, a drug vial bottle
seal 42 is perforated by spike tip 296 and held by spike barb
184.
[0186] As shown on FIGS. 26 and 32-34, drug line lumen 195 is in
fluid communication between spike tip 296 and drug channel 294.
External to drug channel 294 is drug boss 185. On the outside of
drug boss 185 is thread 193 for attaching spike elbow 265. Air-vent
lumen 194 is in fluid communication with air-vent channel 293.
External to air-vent channel 293 is air-vent boss 177. Air-vent
lumen 194 is used to equalize the air pressure inside the drug vial
250, permitting fluid to flow by gravity from the drug vial 250
through drug line lumen 195 into the drug tubing line. In one
construction, there is an air-vent filter 295 (as shown on FIG.
26), commercially available, that snaps into air-vent boss 177.
Generally air-vent filter 295 has a cylindrical shape with a fine
mesh feature on one side. Air-vent filter 295 is permeable to
passage of gases, including air, in either direction though the
air-vent channel 293, but precludes passage of liquid and solid
materials in either direction through air-vent channel 293.
[0187] As shown on FIGS. 26, 28, 32-40, spike 261 has a flat wing
197 base designed as a generally trapezoidal thin plate, with
smooth round corners. The flat thin shape of spike wing 197
facilitates user handling and creates support for spike cap 263.
Two spike apertures 191 are coincident with spike base apertures
292 and serve to align the spike 261 to the vial centering
mechanism in the PRU 200. Spike alignment apertures 298 are used
for alignment when inserting spike 261 on cassette 251 and engages
through spike pins 299, to align spike 261 on spike bed 262.
[0188] As shown on FIGS. 32-40, spike 261 includes snap lock 189 on
top of spike wing 197. Snap lock 189 is integrally formed from
spike wing 197. Snap lock 189 interfaces with spike latch 284
located on spike cap 263 to retain spike cap 263 on spike 261.
[0189] As illustrated on FIGS. 24 and 32-40, spike cap 263 is made
of rigid thermoplastic and is a safety protection device for spike
system 272. Spike cap 263 includes covering head 176, which is a
hollow body, used to cover spike tip 296. Spike hollow 181 has a
generally oblong shape and facilitates the assembly of spike cap
263 over spike tip 296. Spike cap 263 includes cap handle 182 to
facilitate easy handling by the user. On each side of cap handle
182 are located gripper ribs 178. A latching mechanism includes
spike latch 284 and two supporting arms, first arm 179 and second
arm 180, molded integrally on both sides of covering head 176.
Spike latch 284 has a spring-like property and is capable of
deflecting normal to the axis of covering head 176. When spike cap
263 is assembled over spike tip 296, latch 284 is deflected by snap
lock 189 located on spike 296, causing lip 183 to lock onto the
edge of snap lock 189. First arm 179 and second arm 180 prevent
spike cap 263 from tilting. As shown in FIGS. 24, 26, 28-31, the
cassette main board 253 includes two cap-attaching ribs 38 which
provide for a removable snap-fit attachment therebetween of the cap
handle 182 of the spike cap 263 to the cassette main board 253. A
brisk, quick upward force on cap handle 182 will cause spike cap
263 to release from spike 261 and from cap-attaching ribs 38.
[0190] As shown on FIGS. 25 and 26, spike elbow 265 is made of a
rigid thermoplastic and is generally cylindrical in shape with two
openings connected by internal fluid channel 264. One opening of
fluid channel 264 connects to tube 277. The other opening of
channel 264 is in fluid communication with drug channel 294 located
in spike 261, and permits drug(s) to flow by gravity from a spiked
vial through drug lumen 195, and through to tube 277. Spike elbow
265 includes an internally threaded ring to permit spike elbow 265
to be removably attached to spike boss 185 (See FIG. 33). When
spike 261 is properly assembled to cassette main board 253, spike
elbow retains spike 261.
[0191] Drug delivery cassette 251 is for single patient use (SPU)
and is manually loaded in a pump cassette deck 219 on a Procedure
Room Unit (PRU) 200 (shown in FIGS. 41-57). The pump cassette deck
219 has a hinged door that serves to press cassette 251 against the
peristaltic pump 220. Cassette 251 contains intravenous tubing that
is connected to a patient's catheter.
[0192] Procedure Room Unit
[0193] A third aspect of the invention is directed to, or a
component of, or can be used by, a procedure room unit 200, an
embodiment of which is shown in FIGS. 41-57. A first expression of
the embodiment of FIGS. 41-57 is for a drug-delivery infusion pump
assembly 220 including a drug-delivery infusion pump housing 239, a
drug-delivery cassette assembly 251 (an embodiment of which has
been previously discussed and shown in greater detail in FIGS.
24-40), and a pump-housing door 201. The drug-delivery cassette
assembly 251 is attachable to the infusion pump housing 239 and has
a drug-vial spike 261 (See FIG. 32). The pump-housing door 201 is
attached to the infusion pump housing 239, has door-open and
door-closed positions, and has drug-vial-aligning fingers 44. The
drug-vial-aligning fingers 44 center and align different diameter
drug vials 250 when: the cassette assembly 251 is attached to the
infusion pump housing 239; the pump-housing door 201 is in the
door-closed position; and a drug vial 250 is inserted between the
drug-vial-aligning fingers 44 for engagement with the spike
261.
[0194] In one construction of the first expression of the
embodiment of FIGS. 41-57, the drug-vial-aligning fingers 44 center
and align ten and twenty cubic-centimeter drug vials 250 having
different outside diameters and having the same or different
lengths. In one variation, the drug-vial-centering fingers 44
consist essentially of two resilient, concave and opposing fingers.
In the same or a different construction, the pump-housing door 201
is rotatably attached to the infusion pump housing 239 and is
rotatable between the door-open and door-closed positions. Other
constructions and variations are left to the artisan.
[0195] In one example of the first expression of the embodiment of
FIGS. 41-57, the cassette assembly 251 is attachable to, and
removable from, the infusion pump housing 239 when the pump-housing
door 201 is in the door-open position. In the same or a different
example, the drug-delivery infusion pump assembly 220 also includes
a drug-delivery peristaltic pump 232 disposed in the infusion pump
housing 239 and having pump fingers 229. In this example, the
cassette assembly 251 is operatively connectable to the pump
fingers 229 when the cassette assembly 251 is attached to the
infusion pump housing 239 and the pump-housing door 201 is in the
door-open position.
[0196] In one application of the first expression of the embodiment
of FIGS. 41-57, the drug-delivery infusion pump assembly 220 is a
part of a procedure room unit (PRU) 200 of a sedation delivery
system (SDS) 100 (or other type of medical effector system 100')
wherein the SDS 100 (or other type of medical effector system 100')
also has a bedside monitoring unit (BMU) 300 and an umbilical cable
160. In this application, the BMU 300 has a first series of
connection points for receiving input signals from patient
monitoring connections and a second series of connection points for
outputting patient parameters and has a display screen for
displaying patient parameters. In this application, the PRU 200 is
used during a medical procedure and for receiving patient
parameters from the BMU 300 and has a display screen for displaying
patient parameters. In this application, the umbilical cable 160 is
used for communicating patient parameters from the BMU 300 to the
PRU 200.
[0197] A second expression of the embodiment of FIGS. 41-57 is for
a drug-delivery infusion pump assembly 220 and drug-delivery
cassette assembly 251 combination including a drug-delivery
infusion pump housing 239, a drug-delivery cassette assembly 251, a
pump-housing door 201, and a pump-housing door lock 205/222. The
cassette assembly 251 is attachable to the infusion pump housing
239, has a luer 269, and has a drug-delivery-cassette main board
253 including a luer-site base portion 271. The luer 269 is
attachable to and detachable from the luer-site base portion 271.
The pump-housing door 201 is attached to the infusion pump housing
239 and has door-open and door-closed positions. The pump-housing
door lock 205/222, when the cassette assembly 251 is attached to
the infusion pump housing 239, unlocks the pump-housing door 201
when the luer 269 is attached to the luer-site base portion
271.
[0198] In one enablement of the second expression of the embodiment
of FIGS. 41-57, the lock 205/222 includes a pump-door latch 205 and
a door latch solenoid 222 operatively connected to the pump-door
latch 205. Other enablements are left to the artisan. It is noted
that the pump-housing door 201 can be opened to remove the cassette
assembly 251 when the luer 269 is returned to the luer-site base
portion 271 at the end of a medical procedure.
[0199] A third expression of the embodiment of FIGS. 41-57 is for a
sedation-delivery-system procedure room unit 200 (or other type of
medical-effector-system procedure room unit 200') including a
capnometer 140 and 202 and a barcode reader assembly 455. The
capnometer 140 and 202 is adapted to receive directly or indirectly
respiratory gas obtained from a single-patient-use cannula 351'
which is disposable on the face of a patient. The barcode reader
assembly 455 is adapted to read a barcode of a package containing
the cannula 351' and/or a barcode of the cannula 351'.
[0200] An additional third expression of the embodiment of FIGS.
41-57 is for a sedation-delivery-system procedure room unit 200 (or
other type of medical-effector-system procedure room unit 200')
including a drug-delivery infusion pump housing 239 and a barcode
reader assembly 455. The drug-delivery infusion pump housing 239 is
adapted to receive a single-patient-use drug-delivery cassette
assembly 251. The barcode reader assembly 455 is adapted to read a
barcode of a package containing the drug-delivery cassette assembly
251 and/or a barcode of the drug-delivery cassette assembly
251.
[0201] In a further third expression of the embodiment of FIGS.
41-57, the cassette assembly 251 is adapted to receive a
single-patient-use drug vial 250 containing a drug (such as, but
not limited to, a sedation drug), and the barcode reader assembly
455 is adapted to read a barcode of the drug vial 250 and/or a
barcode of a package containing the drug vial 250.
[0202] In one employment of the third expression, the additional
third expression and/or the further third expression of the
embodiment of FIGS. 41-57, the procedure room unit 200 uses the
barcode reader assembly 455 to prevent multiple use of a
single-patient-use item such as the drug-delivery cassette assembly
251, the cannula 351', and the drug vial 250 in the procedure room
unit 200. In another employment, the procedure room unit 200 uses
the barcode reader assembly 455 to match single-patient-use items
to a particular patient. Other employments are left to the
artisan.
[0203] A fourth expression of the embodiment of FIGS. 41-57 is for
a sedation delivery system 100 (or other type of medical effector
system 100') including a microprocessor-based bedside monitoring
unit 300, a microprocessor-based procedure room unit 200, and an
umbilical cable 160. The bedside monitoring unit 300 has a first
series of connection points for receiving patient inputs from
patient monitoring connections, has a second series of connection
points for outputting patient outputs based on the received inputs,
and has a display screen for displaying at least some of the
patient outputs. The procedure room unit 200 has a drug-delivery
flow control assembly 220' (or other type of medical effector
220''), and has a host controller 204 with a memory containing a
patient-monitoring and drug-delivery-scheduling program (or other
type of patient-monitoring and medical-effector scheduling
program). The program is operatively connected to program inputs
based at least in part on at least some of the patient outputs, and
the program controls, and/or advises a user to control, the
drug-delivery flow control assembly 220' (or other type of medical
effector 220'') based at least in part on the program inputs. The
umbilical cable 160 has a first end attached or attachable to the
second series of connection points of the bedside monitoring unit
300 and has a second end attached or attachable to the procedure
room unit 200. At least one of the first and second ends of the
umbilical cable 160 is detachable from the corresponding bedside
monitoring unit 300 or the procedure room unit 200. The procedure
room unit 200 includes an Ethernet and/or a modem connector 471/470
operatively connected to the host controller 204.
[0204] In one arrangement of the fourth expression of the
embodiment of FIGS. 41-57, the drug-delivery flow control assembly
220' includes a drug-delivery infusion pump assembly 220 such as a
peristaltic pump assembly. In one variation of this arrangement,
the drug(s) is delivered to the patient through an IV. In another
arrangement, not shown, the drug-delivery flow control assembly
includes a gaseous-drug gas flow controller. In one variation of
this arrangement, the gaseous drug(s) is oxygen and/or a non-oxygen
gas and is delivered to the patient through a cannula assembly.
[0205] In one employment of the fourth expression of the embodiment
of FIGS. 41-57, the Ethernet and/or modem connector 471/470 is used
for remote software updates of programs residing in the memory of
the host controller 204 of the procedure room unit 200, such as the
patient-monitoring and drug-delivery-scheduling program (or other
type of patient-monitoring and medical-effector-scheduling
program). The term "memory" includes all memory of the host
controller 204 including, in one example, all memory of the system
input/output board 451 of the host controller and all memory of the
processor board 452 of the host controller. In the same or a
different employment, the host controller 204 of the procedure room
unit 200 uses the Ethernet and/or modem connector 471/470 to send
patient data to a remote computer for data management purposes.
Other employments are left to the artisan. In one construction, the
procedure room unit 200 has only an Ethernet connector 471 and not
a modem connector 470. In a different construction, only a modem
interface 470 and not an Ethernet interface 471 is present. In
another construction, both an Ethernet and a modem interface 471
and 470 are present. In one enablement of the fourth expression of
the embodiment of FIGS. 41-57, the procedure room unit 200 includes
a monitor display 442 for displaying at least some of the program
inputs and the status of the drug-delivery flow control assembly
220' (or other type of medical effector 220'').
[0206] A fifth expression of the embodiment of FIGS. 41-57 is for a
sedation delivery system 100 (or other type of medical effector
system 100') including a microprocessor-based bedside monitoring
unit 300, a microprocessor-based procedure room unit 200, and an
umbilical cable 160. The bedside monitoring unit 300 has a first
series of connection points for receiving patient inputs from
patient monitoring connections, has a second series of connection
points for outputting patient outputs based on the received inputs,
and has a display screen for displaying at least some of the
patient outputs. The procedure room unit 200 has a drug-delivery
flow control assembly 220' (or other type of medical effector
220''), and has a host controller 204 with a memory containing a
patient-monitoring and drug-delivery-scheduling program (or other
type of patient-monitoring and medical-effector-scheduling
program). The program is operatively connected to program inputs
based at least in part on at least some of the patient outputs. The
program controls, and/or advises a user to control, the
drug-delivery flow control assembly 220' (or other type of medical
effector 220'') based at least in part on the program inputs. The
umbilical cable 160 has a first end attached or attachable to the
second series of connection points of the bedside monitoring unit
300 and has a second end attached or attachable to the procedure
room unit 200. At least one of the first and second ends of the
umbilical cable 160 is detachable from the corresponding bedside
monitoring unit 300 or the procedure room unit 200. The host
controller 204 of the procedure room unit 200 includes Health Level
Seven application protocol to electronically send and/or receive
communications to and/or from a remote computer.
[0207] In one employment of the fifth expression of the embodiment
of FIGS. 41-57, the Health Level Seven application protocol is used
to electronically send patient data to a remote computer for data
management purposes. In the same or a different employment, the
Health Level Seven application protocol is used to electronically
receive remote servicing of (such as running remote diagnostic
programs on) the procedure room unit 200. Other applications are
left to the artisan.
[0208] A sixth expression of the embodiment of FIGS. 41-57 is for a
sedation delivery system 100 (or other type of medical effector
system 100') including a microprocessor-based bedside monitoring
unit 300, a microprocessor-based procedure room unit 200, and an
umbilical cable 160. The bedside monitoring unit 300 has a first
series of connection points for receiving patient inputs from
patient monitoring connections, has a second series of connection
points for outputting patient outputs based on the received inputs,
and has a display screen for displaying at least some of the
patient outputs. The procedure room unit 200 has a drug-delivery
flow control assembly 220' (or other type of medical effector
220''), and has a host controller 204 with a memory containing a
patient-monitoring and drug-delivery-scheduling program (or other
type of patient monitoring and medical-effector-scheduling
program). The program is operatively connected to program inputs
based at least in part on at least some of the patient outputs. The
program controls, and/or advises a user to control, the
drug-delivery flow control assembly 220' (or other type of end
effector 220'') based at least in part on the program inputs. The
umbilical cable 160 has a first end attached or attachable to the
second series of connection points of the bedside monitoring unit
300 and has a second end attached or attachable to the procedure
room unit 200. At least one of the first and second ends of the
umbilical cable 160 is detachable from the corresponding bedside
monitoring unit 300 or the procedure room unit 200. The procedure
room unit 200 includes a printer 454 operatively connected to the
host controller 204.
[0209] In one employment of the sixth expression of the embodiment
of FIGS. 41-57, the printer 454 is used to create a printed patient
record of the role of the sedation delivery system 100 (or other
type of medical effector system 100') during the medical procedure
undergone by the patient. In one example of the sixth expression of
the embodiment of FIGS. 36-52, the procedure room unit 200 includes
a procedure-room-unit console 444, wherein the console 444 contains
the drug-delivery flow control assembly 220' (or other type of
medical effector 220''), the host controller 204, and the printer
454. In one construction, the printer 454 is a thermal printer.
[0210] A seventh expression of the embodiment of FIGS. 41-57 is for
a sedation delivery system 100 comprising a microprocessor-based
bedside monitoring unit 300, a microprocessor-based procedure room
unit 200, and an umbilical cable 160. The bedside monitoring unit
300 has a bedside-monitoring-unit host controller 301 (See FIG.
62), which contains a first program. The first program performs the
steps of: issuing a request to a non-sedated patient for a
non-sedated patient response; receiving a signal based on the
non-sedated patient response; and calculating a non-sedated
response time for the patient based at least in part on a time
difference between issuing the request and receiving the signal.
The procedure room unit 200 has a procedure-room-unit host
controller 204, which contains a second program. The second program
performs the steps of: issuing requests through the bedside
monitoring unit 300 to a sedated patient for a sedated patient
response; receiving a signal through the bedside monitoring unit
300 based on the sedated patient response; calculating a sedated
response time for the sedated patient, and calculating a response
time difference between the non-sedated and sedated response times.
The umbilical cable 160 has a first end attached or attachable to
the bedside monitoring unit 300 and has a second end attached or
attachable to the procedure room unit 200. At least one of the
first and second ends is detachable from the corresponding bedside
monitoring unit 300 or the procedure room unit 200.
[0211] In one example of the seventh expression of the embodiment
of FIGS. 41-57, the procedure room unit 200 has a drug-delivery
infusion pump assembly 220. The drug-delivery infusion pump
assembly 220 is controlled by the procedure-room-unit host
controller 204 based at least in part on the response time
difference. In the same or a different example, the sedation
delivery system 100 includes a cannula assembly 145 disposable on
the face of a patient and having a respiratory gas sampling tube
354, 352 and 355 (See FIG. 1). The respiratory gas sampling tube
354, 352 and 355 (See FIG. 1) is connectable to the bedside
monitoring unit 300. The procedure room unit 200 includes a
capnometer 202 and 140 having a capnometer output signal, and the
umbilical cable 160 is operatively connectable to the respiratory
gas sampling tube 354, 352 and 355 and the capnometer 202 and 140.
The drug-delivery infusion pump assembly 220 is controlled at least
in part by the capnometer output signal.
[0212] In one employment of the seventh expression of the
embodiment of FIGS. 41-57, the bedside monitoring unit 300 uses an
audio earpiece 362 (See FIG. 1) to provide the patient 10 with
requests to squeeze an automated-responsiveness-monitor (ARM)
handset 342 (e.g., a handpiece which, in one illustration includes
a vibrator to also request a response from the patient) to
calculate patient response times. The requests are issued by the
bedside monitoring unit 300 in a pre-procedure room to train the
non-sedated patient to use the ARM handset 342 and to calculate the
non-sedated response time. The requests are issued by the procedure
room unit 200 (and transmitted to the bedside monitoring unit 300
through the umbilical cable 160) when the patient undergoes
sedation in the procedure room to calculate sedated response times
throughout the procedure. The requests are issued by the bedside
monitoring unit 300 in a post-procedure room to present YES/NO
questions, multiple choice questions, time-based responsiveness
queries or other such prompt/reply interactions and combine the
responses with other monitored parameters to conduct patient
assessment. An example would be a series of questions/activities to
show cognitive and motor functions prior to patient discharge. A
further example would be to monitor the level of responsiveness and
alerting the appropriate medical staff if the patient does not
reach certain defined thresholds within an appropriate period of
time.
[0213] A still further example would be to utilize the ARM handset
342 in place of a call button. While patients are in the
pre-procedure or post-procedure room, a long squeeze or rapid
squeezes on ARM handset 342 would be detected by BMU 300 as a
request for assistance. BMU 300 would then log the request, post it
on the BMU GUI 212 (See FIG. 60) and illuminate the light bar 208
(See FIG. 60) in an appropriate color or flashing scheme.
[0214] A further example is BMU 300 detecting a low respiration
rate, apnea condition, or low SpO.sub.2 and communicating this
status to the patient. BMU 300 would send an audio request, such as
"TAKE A DEEP BREATH" to the patient by way of audio earpiece 362,
instructing the patient to take a deep breath. The command may be
repeated at a predetermined time interval if the patient's
respiration rate does not increase. Furthermore, the command may be
initially provided at a first nominal volume level, and subsequent
commands are provided at a second volume level, higher than said
first volume level. If the patient does not respond to the request
for respiration, an alarm will alert the care team of the patient's
condition. Other similar type of audio commands may be given to the
patient as other conditions warrant a specific patient
response.
[0215] An eighth expression of the embodiment of FIGS. 41-57 is for
a sedation-delivery-system procedure room unit 200 (or other type
of medical-effector-system procedure room unit 200') comprising a
procedure-room-unit host controller 204 which contains an oxygen
delivery program which performs the steps of: receiving a
pulse-oximeter signal from a patient undergoing sedation and
calculating an oxygen flow rate based at least in part on the
received pulse-oximeter signal, wherein the procedure-room-host
controller 204 controls a flow of oxygen to the patient based on
the calculated oxygen flow rate.
[0216] In the eighth expression of the embodiment of FIGS. 41-57,
the oxygen flow rate to the patient is variable and is based at
least in part on patient blood oxygen levels from the received
pulse-oximeter signal. It is noted that the term "oxygen", when
describing oxygen delivery, includes air with an enriched oxygen
content.
[0217] A first extension of the eighth expression of the embodiment
of FIGS. 41-57 is for a sedation delivery system 100 (or other type
of medical-effector system 100') including the
sedation-delivery-system procedure room unit 200 (or other type of
medical-effector-system procedure room unit 200') as described in
the previous paragraph, including a bedside monitoring unit 300,
and including an umbilical cable 160. The umbilical cable 160 has a
first end attached or attachable to the bedside monitoring unit 300
and has a second end attached or attachable to the procedure room
unit 200. At least one of the first and second ends is detachable
from the corresponding bedside monitoring unit 300 or the procedure
room unit 200. When the umbilical cable 160 is attached to the
procedure room unit 200 and the bedside monitoring unit 300, the
pulse-oximeter signal flows from the patient through the bedside
monitoring unit 300 and through the umbilical cable 160 to the
procedure room unit 200 and the flow of oxygen flows through the
umbilical cable 160 and the bedside monitoring unit 300 to the
patient.
[0218] A ninth expression of the embodiment of FIGS. 41-57 is for
medical oxygen-delivery apparatus including an oxygen-delivery
manifold 206 having an oxygen-delivery flow path, a
fixed-size-orifice flow restrictor 489, and a variable-size-orifice
flow restrictor 480. The oxygen-delivery flow path includes a
flow-path inlet fluidly-connectable to a source of pressurized
oxygen and a flow-path outlet fluidly-connectable to a cannula 351'
disposable on the face of a patient. The fixed-size-orifice flow
restrictor 489 is disposed in the flow path downstream of the
flow-path inlet, and the variable-size-orifice flow restrictor 480
is disposed in the flow path downstream of the fixed-size-orifice
flow restrictor 489.
[0219] In one example of the ninth expression of the embodiment of
FIGS. 41-57, the medical oxygen-delivery apparatus also includes a
high side pressure sensor 487 in fluid communication with the flow
path at a first location disposed between the flow-path inlet and
the fixed-size-orifice flow restrictor 489 and includes a
differential pressure sensor 479 in fluid communication with the
flow path at an entrance location disposed between the first
location and the fixed-size-orifice flow restrictor 489 and at an
exit location disposed between the fixed-size-orifice flow
restrictor 489 and the variable-size-orifice flow restrictor 480.
The orifice size of the variable-size-orifice flow restrictor 480
is related to the measured pressure and pressure difference and is
used to control the flow rate as is within the routine capabilities
of those skilled in the art. In the same or a different example,
the variable-size-orifice flow restrictor 480 is a
variable-size-orifice solenoid. In one application, the
oxygen-delivery manifold 206 is a subassembly of a procedure room
unit 200 of a sedation delivery system 100 (or other type of
medical effector system 100').
[0220] A tenth expression of the embodiment of FIGS. 41-57 is for a
sedation-delivery-system procedure room unit 200 (or other
medical-effector-system procedure room unit 200') including a
procedure-room-unit host controller 204, which contains an oxygen
delivery program. The program performs the steps of: controlling
the delivery of oxygen at a predetermined first rate to at least
one respiratory-gas-delivery oral prong 369''/371'' of a cannula
assembly 145 operatively connected to a patient, when the patient
is determined to be inhaling and exhaling through the mouth;
controlling the delivery of oxygen at a predetermined second rate
to at least one respiratory-gas-delivery nasal prong 422' and 422''
of the cannula assembly 145 when the patient is determined to be
breathing through the nose and when the patient is determined to be
inhaling; and controlling the delivery of oxygen at a predetermined
third rate to the at-least-one respiratory-gas-delivery nasal prong
422' or 422'' when the patient is determined to be breathing
through the nose and when the patient is determined to be exhaling.
The second rate is higher than the third rate.
[0221] In one example of the tenth expression of the embodiment of
FIGS. 41-57, when oxygen flows, oxygen always flows to all
respiratory-gas-delivery oral and nasal prongs when the rate of
oxygen delivery is being controlled to either the
respiratory-gas-delivery oral or nasal prongs.
[0222] In one enablement of the tenth expression of the embodiment
of FIGS. 41-57, the oxygen delivery program also performs the steps
of determining that the patient is breathing through the nose or
the mouth and, if through the nose, that the patient is inhaling or
exhaling based at least in part on nasal pressure readings from
sampled respiratory gas taken from at least one
respiratory-gas-sampling nasal prong 364 and 365 of the cannula
assembly 145.
[0223] A first alternate tenth expression of the embodiment of
FIGS. 41-57 is for a medical-effector-system procedure room unit
200' (such as a sedation-delivery-system procedure room unit 200')
including a procedure-room-unit host controller 204 which contains
an oxygen delivery program. The program performs the steps of:
controlling the delivery of oxygen at a variable first rate to at
least one respiratory-gas-delivery oral prong 369''/371'' of a
cannula assembly 145 operatively connected to a patient, when the
patient is determined to be inhaling and exhaling through the
mouth; controlling the delivery of oxygen at a variable second rate
to at least one respiratory-gas-delivery nasal prong 422' and 422''
of the cannula assembly 145 when the patient is determined to be
breathing through the nose and when the patient is determined to be
inhaling; and controlling the delivery of oxygen at a variable
third rate to the at-least-one respiratory-gas-delivery nasal prong
422' and 422'' when the patient is determined to be breathing
through the nose and when the patient is determined to be exhaling.
The patient has a variable percentage of blood oxygen saturation,
and the first, second and third rates depend on the percentage of
blood oxygen saturation.
[0224] In one enablement of the first alternate tenth expression of
the embodiment of FIGS. 41-57, the second rate is a fixed low rate
for percentages of blood oxygen saturation above a predetermined
high percentage and is a fixed high rate for percentages of blood
oxygen saturation below a predetermined low percentage. In one
variation, the second rate steps up a plurality of times from the
fixed low rate to the fixed high rate as the percentage of blood
oxygen saturation decreases from the predetermined high percentage
to the predetermined low percentage. In one modification, the
second rate is higher than the third rate for the same percentage
of blood oxygen saturation. In one implementation, the third rate
is zero at the predetermined high percentage. In the same or a
different enablement, the first rate corresponding to a particular
percentage of blood oxygen saturation is the arithmetic mean of the
second and third rates corresponding to the particular percentage
of blood oxygen saturation. In the same or a different enablement,
the oxygen delivery program accepts a user input to raise, but
never lower, the second rate above the fixed low rate when the
percentage of blood oxygen saturation is above, but never below,
the predetermined high percentage. In one variation, the oxygen
delivery program accepts a user input to raise, but never lower,
the third rate when the percentage of blood oxygen saturation is
above, but never below, the predetermined high percentage.
[0225] In one example of the first alternate tenth expression of
the embodiment of FIGS. 41-57, the second rate is substantially 2
liters per minute and the third rate is 0 liters per minute for a
predetermined high percentage of substantially 96%, and the second
rate is substantially 15 liters per minute and the third rate is
substantially 2 liters per minute for a predetermined low
percentage of substantially 84%. In this example, the second rate
is substantially 8 liters per minute and the third rate is
substantially 2 liters per minute when the percentage of blood
oxygen saturation is between substantially 88% and 96%, and the
second rate is substantially 12 liters per minute and the third
rate is substantially 2 liters per minute when the percentage of
blood oxygen saturation is between substantially 84% and 88%.
Benefits and advantages of this example include basing the oxygen
delivery rate on the patient's oxygen saturation level, which
provides a higher oxygen delivery rate for a patient having low
blood oxygen saturation while providing a lower oxygen delivery
rate for a patient having high blood oxygen saturation, which
conserves oxygen use. In this example, the flow rates may be
associated with a patient that is predominantly nasal breathing. If
the patient is predominantly oral breathing (indicated by the
absence of a nasal pressure signal) the flow rate may be the
arithmetic means of the inhalation and exhalation rates for each
blood oxygen segment.
[0226] A second alternate tenth expression of the embodiment of
FIGS. 41-57 is for a medical-effector-system procedure room unit
200' (such as a sedation-delivery-system procedure room unit 200)
including a procedure-room-unit host controller 204 which contains
an oxygen delivery program. The program performs the steps of:
controlling the delivery of oxygen at a variable nasal-inhale
oxygen-delivery flow rate to at least one respiratory-gas-delivery
nasal prong 422' and 422'' of a cannula assembly 145 operatively
connected to a patient, when the patient is determined to be
breathing through the nose and when the patient is determined to be
inhaling; and controlling the delivery of oxygen at a nasal-exhale
oxygen-delivery flow rate to the at-least-one
respiratory-gas-delivery nasal prong 422' and 422'' when the
patient is determined to be breathing through the nose and when the
patient is determined to be exhaling. The patient has a variable
percentage of blood oxygen saturation, and the nasal-inhale
oxygen-delivery flow rate is a variable rate, which depends on the
percentage of blood oxygen saturation.
[0227] In one enablement of the second alternate tenth expression
of the embodiment of FIGS. 41-57, the nasal-exhale oxygen-delivery
flow rate is a variable rate, which depends on the percentage of
blood oxygen saturation, and the nasal-inhale oxygen-delivery rate
is greater than the nasal-exhale oxygen-delivery rate for the same
percentage of blood oxygen saturation.
[0228] An eleventh expression of the embodiment of FIGS. 41-57 is
for medical oxygen-delivery apparatus including an oxygen-delivery
manifold 206. The oxygen-delivery manifold 206 has an
oxygen-delivery flow path and an oxygen-sampling flow path
fluidly-connectable to the oxygen-delivery flow path. The
oxygen-delivery flow path includes a flow-path inlet
fluidly-connectable to a source of pressurized oxygen and a
flow-path outlet fluidly-connectable to a cannula 351' disposable
on the face of a patient. The oxygen-sampling flow path includes an
oxygen sensor 482, which detects hypoxic gas.
[0229] In one example of the eleventh expression of the embodiment
of FIGS. 41-57, an oxygen sample solenoid 481 fluidly connects the
oxygen-sampling flow path to the oxygen-delivery flow path. In one
implementation, a detection of hypoxic (low oxygen) gas by the
oxygen sensor 482 is used to issue a user alert to check the source
of oxygen. In one employment, the oxygen-delivery manifold 206 is a
subassembly of a procedure room unit 200 of a sedation delivery
system 100 (or other type of medical-effector system 100').
[0230] A twelfth expression of the embodiment of FIGS. 41-57 is for
a sedation-delivery-system procedure room unit 200 (or other type
of medical-effector-system procedure room unit 200') including a
procedure-room-unit host controller 204 and a capnometer 140 and
202. The capnometer 140 and 202 has a capnometer gas input which
receives directly or indirectly respiratory gas obtained from a
cannula 351' which is disposable on the face of a patient. The
capnometer 140 and 202 also has a capnometer signal output
operatively connected to the procedure-room-unit host controller
204. The procedure-room-unit host controller 204 issues a user
alert that the capnometer 140 and 202 is fluidly connected and/or
not fluidly connected to the cannula 351' based at least in part on
the capnometer signal output of the capnometer 140 and 202.
[0231] In one example of the twelfth expression of the embodiment
of FIGS. 41-57, the capnometer input receives indirectly
respiratory gas obtained from the cannula 351' through an
intervening bedside monitoring unit 300. The bedside monitoring
unit 300 is attachable to the cannula 351' and is attached or
attachable to a first end of an umbilical cable 160. The umbilical
cable 160 has a second end attached or attachable to the procedure
room unit 200. At least one of the first and second ends is
detachable from the corresponding bedside monitoring unit 300 or
the procedure room unit 200. Typically, in this example, a detached
umbilical cable 160 would be responsible for most user alerts from
the procedure-room-unit host controller 204 that the capnometer 140
and 202 is not fluidly connected to the cannula 351'. In one
enablement, the procedure-room-unit host controller 204 determines
that the capnometer 140 and 202 is fluidly connected to the cannula
351' if the capnometer output indicates a valid respiratory rate of
the patient based on a rise and fall of the capnometer output
(i.e., a rise and fall of the carbon dioxide level measured by the
capnometer 140 and 202).
[0232] A thirteenth expression of the embodiment of FIGS. 41-57 is
for a sedation-delivery-system procedure room unit 200 (or other
type of medical-effector-system procedure room unit 200') including
a sedation-delivery-system procedure-room-unit console 444 (or
other type of medical-effector-system procedure-room-unit console
444') having a console fan 456 and a capnometer subassembly 140/202
and 141/142. The console fan 456 moves air into, through, and out
of the procedure-room-unit console 444 (or 444'). The capnometer
subassembly 140/202 and 141/142 has a capnometer-subassembly gas
inlet and a capnometer-subassembly gas outlet. The
capnometer-subassembly gas outlet is disposed to enable gas leaving
the capnometer-subassembly gas outlet to be entrained with air
moved by the console fan 456.
[0233] In one example of the thirteenth expression of the
embodiment of FIGS. 41-57, the capnometer subassembly 140/202 and
141/142 has a capnometer 140 and 202 and a capnometer pump 141 and
142 operatively connected to the capnometer 140 and 202. In one
construction of this example, gas flows from the
capnometer-subassembly gas inlet to the capnometer to the
capnometer pump and to the capnometer-subassembly gas outlet. In
another construction of this example, gas flows from the
capnometer-subassembly gas inlet to the capnometer pump to the
capnometer and to the capnometer-subassembly gas outlet. One
benefit of having gas from the capnometer-subassembly gas outlet be
fan-vented outside the console by the console fan is that such
outlet gas is less likely to contaminate the capnometer
calibration. In one arrangement, calibration gas and console fan
air are drawn in the front of the console and exhausted from the
back of the console.
[0234] In one extension of the thirteenth expression of the
embodiment of FIGS. 41-57, a sedation delivery system 100 (or other
type of medical-effector system 100') includes the
sedation-delivery-system procedure room unit 200 (or other type of
medical-effector-system procedure room unit 200') described in the
second previous paragraph, includes a bedside monitoring unit 300,
and includes an umbilical cable 160. The umbilical cable 160 has a
first end attached or attachable to the bedside monitoring unit 300
and has a second end attached or attachable to the procedure room
unit 200. At least one of the first and second ends is detachable
from the corresponding bedside monitoring unit 300 or the procedure
room unit 200.
[0235] A fourteenth expression of the embodiment of FIGS. 41-57 is
for a sedation-delivery-system procedure room unit 200 (or other
type of medical-effector-system procedure room unit 200) including
a procedure-room-unit host controller 204, a capnometer 140 and
202, an oxygen manifold, 206, and a low side pressure sensor 488.
The capnometer 140 and 202 has a capnometer gas input which
receives directly or indirectly respiratory gas obtained from a
cannula 351' which is disposable on the face of a patient and has a
capnometer signal output operatively connected to the
procedure-room-unit host controller 204. The oxygen manifold 206
has an oxygen-delivery flow path including in series a flow-path
inlet fluidly-connectable to a source of pressurized oxygen, a flow
restrictor 489 and 480, and a flow-path outlet fluidly-connectable
to the cannula 351'. The low side pressure sensor 488 is in fluid
communication with the flow-path outlet, is disposed downstream of
any oxygen-manifold flow restrictor 489 and 480, and has a low-side
pressure signal output operatively connected to the
procedure-room-unit host controller 204. The procedure-room-unit
host controller 204 issues a user alert that the capnometer 140 and
202 is fluidly connected and/or not fluidly connected to the
cannula 351' based at least in part on the capnometer signal output
of the capnometer 140 and 202 and the low-side pressure signal
output of the low side pressure sensor 488.
[0236] In one example of the fourteenth expression of the
embodiment of FIGS. 41-57, the capnometer input receives indirectly
respiratory gas obtained from the cannula 351' through an
intervening bedside monitoring unit 300 which is attachable to the
cannula 351' and attached or attachable to a first end of an
umbilical cable 160 having a second end attached or attachable to
the procedure room unit 200. The flow-path outlet of the oxygen
manifold 206 is indirectly fluidly-connected to the cannula 351'
through the bedside monitoring unit 300 and the umbilical cable
160. At least one of the first and second ends is detachable from
the corresponding bedside monitoring unit 300 or the procedure room
unit 200.
[0237] A fifteenth expression of the embodiment of FIGS. 41-57 is
for a sedation-delivery-system procedure room unit 200 (or other
type of medical-effector-system procedure room unit 200') including
a procedure-room-unit host controller 204, a capnometer 140 and 202
and a capnometer pump 141 and 142. The capnometer 140 and 202 has a
capnometer gas input which receives directly or indirectly
respiratory gas obtained from a cannula 351' which is disposable on
the face of a patient. The capnometer 140 and 202 also has a
capnometer signal output operatively connected to the
procedure-room-unit host controller 204. The capnometer pump 141
and 142 is operatively connected to the capnometer 140 and 202 and
is controlled by the procedure-room-unit host controller 204. The
procedure-room-unit host controller 204 determines that the
capnometer 140 and 202 is fluidly connected and/or not fluidly
connected to the cannula 351' based at least in part on the
capnometer signal output of the capnometer 140 and 202. The
procedure-room-unit host controller 204 shuts off, with or without
a time delay, the capnometer pump 141 and 142 when the capnometer
140 and 202 is not fluidly connected to the cannula 351'. In one
employment, shutting off the capnometer pump 141 and 142 during
times when the cannula 351' is not in use avoids pollutants,
impurities, etc. in the air from contaminating the capnometer 140
and 202 during such times.
[0238] In one example of the fifteenth expression of the embodiment
of FIGS. 41-57, the capnometer input receives indirectly
respiratory gas obtained from the cannula 351' through an
intervening bedside monitoring unit 300. The bedside monitoring
unit 300 is attachable to the cannula 351' and is attached or
attachable to a first end of an umbilical cable 160. The umbilical
cable 160 has a second end attached or attachable to the procedure
room unit 200. At least one of the first and second ends is
detachable from the corresponding bedside monitoring unit 300 or
the procedure room unit 200.
[0239] A sixteenth expression of the embodiment of FIGS. 41-57 is
for a sedation-delivery-system procedure room unit 200 (or other
type of medical-effector-system procedure room unit 200') including
a procedure-room-unit host controller 204, a capnometer 140 and
202, and an ambient-air pressure sensor 46. The capnometer 140 and
202 has a capnometer gas input which receives directly or
indirectly respiratory gas obtained from a cannula 351' which is
disposable on the face of a patient. The capnometer 140 and 202 has
a capnometer signal output operatively connected to the
procedure-room-unit host controller 204. The ambient-air pressure
sensor 46 has an ambient-air-pressure-sensor signal output
operatively connected to the procedure-room-unit host controller
204. The procedure-room-unit host controller 204 determines if the
sedation-delivery-system procedure room unit 200 (or other type of
medical-effector-system procedure room unit 200') has been moved to
a new location having an altitude difference greater than a
predetermined altitude difference using at least the
ambient-air-pressure-sensor signal output of the ambient-air
pressure sensor 46. The procedure-room-unit host controller 204
issues a capnometer-calibration user alert when the
sedation-delivery-system procedure room unit 200 (or other type of
medical-effector-system procedure room unit 200') has been moved to
a new location having an altitude difference greater than the
predetermined altitude difference.
[0240] In one example of the sixteenth expression of the embodiment
of FIGS. 41-57, the capnometer input receives indirectly
respiratory gas obtained from the cannula 351' through an
intervening bedside monitoring unit 300. The bedside monitoring
unit 300 is attachable to the cannula 351' and is attached or
attachable to a first end of an umbilical cable 160. The umbilical
cable 160 has a second end attached or attachable to the procedure
room unit 200. At least one of the first and second ends is
detachable from the corresponding bedside monitoring unit 300 or
the procedure room unit 200.
[0241] A seventeenth expression of the embodiment of FIGS. 41-57 is
for a sedation-delivery-system procedure room unit 200 (or other
type of medical-effector-system procedure room unit 200') including
a procedure-room-unit host controller 204, a cannula 351', and an
oxygen manifold 206. The cannula 351' is disposable on the face of
a patient and has a respiratory-gas-sample output operatively
connectable to the procedure-room-unit host controller 204. The
oxygen manifold 206 has a flow-path outlet fluidly-connectable to
the cannula 351' and has a variable-size-orifice flow restrictor
480 operatively connected to, and disposed upstream of, the
flow-path outlet. The procedure-room-unit host controller 204
determines when the patient is first breathing with a disposed
cannula 351' based at least on the respiratory-gas-sample output of
the cannula 351' and opens the variable-size-orifice flow
restrictor 480 when the patient is first determined to be breathing
with a disposed cannula 351'.
[0242] In one enablement of the seventeenth expression of the
embodiment of FIGS. 41-57, the respiratory-gas-sample output of the
cannula 351' is operatively connected to the procedure-room-unit
host controller 204 via a pressure transducer (such as nasal
pressure transducer 47) and/or through a capnometer 140 and 202. In
the same or a different enablement, the variable-size-orifice flow
restrictor 480 is a variable-size-orifice solenoid.
[0243] In one application of any of the above-described expressions
of FIGS. 41-57, including examples, etc. thereof, the procedure
room unit 200 is directly attachable to a bedside monitoring unit
300. Other applications are left to the artisan.
[0244] Any one or more of the above-described expressions of the
embodiment of FIGS. 41-57, including examples, etc. thereof can be
combined with any other one or more of the above-described
expressions of the embodiment of FIGS. 41-57, including examples,
etc. thereof, as can be appreciated by those skilled in the
art.
[0245] In an alternate embodiment, as shown in FIG. 58, a procedure
room unit 50 includes an energy-delivery medical effector 52. An
expression of the embodiment of FIG. 58 is for a medical effector
system 54 including a microprocessor-based bedside monitoring unit
56, a microprocessor-based procedure room unit 50, and an umbilical
cable 58. The bedside monitoring unit 56 has a first series of
connection points 60 for receiving patient inputs from patient
monitoring connections, has a second series of connection points 62
for outputting patient outputs based on the received inputs, and
has a display screen 64 for displaying at least some of the patient
outputs. The procedure room unit 50 has an energy-delivery medical
effector 52, and has a host controller 66 with a memory containing
a patient-monitoring and medical-effector-scheduling program which
is operatively connected to program inputs based at least in part
on at least some of the patient outputs and which controls, and/or
advises a user to control, the energy-delivery medical effector 52
based at least in part on the program inputs. The umbilical cable
58 has a first end attached or attachable to the second series of
connection points 62 of the bedside monitoring unit 56 and has a
second end attached or attachable to the procedure room unit 50. At
least one of the first and second ends is detachable from the
corresponding bedside monitoring unit 56 or the procedure room unit
50. In one example, the energy-delivery medical effector 52
includes at least one magnetic flux generator 68 adapted to deliver
a time varying magnetic field to a patient to have a sedative
effect on the patient. In one variation, the at-least-one magnetic
flux generator 68 includes a coil 70.
[0246] FIG. 59 shows an embodiment of a medical effector subsystem
306. A first expression of the embodiment of FIG. 59 is for a
medical effector subsystem 306 including a drug-delivery tube 308,
a pressure sensor 324, and a memory 326. The drug-delivery tube 308
is adapted to contain therein a drug 328 having a variable
commanded flow rate and is disposable to deliver the drug to a
patient 336. The pressure sensor 324 has an output signal 338 and
is adapted to sense internal pressure of the drug-delivery tube
308. The memory 326 contains an occlusion program which when
running on a processor 344 is operatively connected to the output
signal 338 of the pressure sensor 324. The occlusion program has a
variable pressure alarm setting and alerts a user of an occluded
drug-delivery tube 308 when the output signal 338 of the pressure
sensor 324 exceeds the variable pressure alarm setting. The
occlusion program changes the variable pressure alarm setting based
at least in part, and directly or indirectly, on the variable
commanded flow rate of the drug 328.
[0247] The term "occluded" includes partially occluded and
completely occluded. Causes of an occluded drug-delivery tube 308
include, without limitation, a bent, twisted, squeezed, and/or
blocked tube. In one operation of the first expression of the
embodiment of FIG. 59, the drug 328 is a pumped drug, which is
pumped at the variable commanded flow rate. In this operation, when
the drug-delivery tube 308 is occluded, the continued pumping of
the drug 328 increases the internal pressure of the drug-delivery
tube 308. It is noted that changing the variable pressure alarm
setting based on commanded or actual pump speed is changing the
variable pressure alarm setting based indirectly on the variable
commanded flow rate of the drug, as is understood by the artisan.
In one arrangement, since increasing the drug flow rate increases
the internal pressure of a non-occluded tube, the variable pressure
alarm setting is set to always be higher (by a predetermined amount
in one example) than the non-occluded tube internal pressure
corresponding to the present commanded flow rate (or corresponding
to the present commanded or actual pump speed).
[0248] In one implementation of the first expression of the
embodiment of FIG. 59, the occlusion program sets the variable
pressure alarm setting to a fixed low setting when the variable
commanded flow rate is below a predetermined value and sets the
variable pressure alarm setting to a fixed high setting when the
variable commanded flow rate is at or above the predetermined
value. In a different implementation, the occlusion program changes
the variable pressure alarm setting whenever there is a change in
the variable commanded flow rate. Other implementations are left to
the artisan.
[0249] In one employment of the first expression of the embodiment
of FIG. 59, the drug-delivery tube 308 is an intravenous
drug-delivery tube. In a different employment, not shown, the
drug-delivery tube is a pneumatic tube, wherein the drug is a
gaseous drug. As previously mentioned, oxygen (i.e., air having an
enriched oxygen content) is an example, without limitation, of a
gaseous drug.
[0250] In one constuction of the first expression of the embodiment
of FIG. 59, the pressure sensor 324 includes a pressure-sensitive
input portion 346 and the drug-delivery tube 308 has an imperforate
outside surface portion 348. In this construction, the input
portion 346 of the pressure sensor 324 is disposed in contact with
the imperforate outside surface portion 348 of the drug-delivery
tube 308. Other pressure sensor and/or drug-delivery tube types and
constructions are left to the artisan including, without
limitation, a pressure sensor input which is in fluid communication
with the drug inside the drug-delivery tube.
[0251] In one enablement of the first expression of the embodiment
of FIG. 59, the memory 326 and the processor 344 are components of
a host controller of a procedure room unit (such as host controller
204 of the previously-described procedure room unit 200). In one
variation, the memory 326 also contains a drug delivery algorithm,
such as the previously mentioned Dosage Controller (DC) algorithm,
which when running on the processor 344 determines the variable
commanded flow rate. In one modification, the variable commanded
flow rate includes a zero flow rate, a fixed maintenance flow rate,
and a much larger fixed bolus flow rate. Other modifications,
variations, and enablements are left to the artisan.
[0252] In one application of the first expression of the embodiment
of FIG. 59, the medical effector subsystem 306 also includes an
infusion pump 350, which is adapted to receive the variable
commanded flow rate. The infusion pump 350 has peristaltic pump
fingers 372. The peristaltic pump fingers 372 are disposed to
interact with the drug-delivery tube 308 and are controllable to
pump the drug 328 at the variable commanded flow rate.
[0253] A second expression of the embodiment of FIG. 59 is for a
medical effector subsystem 306 including a drug-delivery tube 308,
a pressure sensor 324, and a memory 326. The drug-delivery tube 308
is adapted to contain therein a drug 328 having a variable
commanded flow rate, is disposable to deliver the drug 328 to a
patient 336, and includes an imperforate outside surface portion
348. The pressure sensor 324 has an output signal 338 and includes
a pressure-sensitive input portion 346 disposed in contact with the
imperforate outside surface portion 348 of the drug-delivery tube
308. The memory 326 contains an occlusion program which when
running on a processor 344 is operatively connected to the output
signal 338 of the pressure sensor 324. The occlusion program has a
variable pressure alarm setting and alerts a user of an occluded
drug-delivery tube 308 when the output signal 338 of the pressure
sensor 324 exceeds the variable pressure alarm setting. The
occlusion program changes the variable pressure alarm setting based
entirely, and directly, on the variable commanded flow rate of the
drug 328.
[0254] A third expression of the embodiment of FIG. 59 is for a
medical effector subsystem 306 including a drug-delivery tube 308,
a pressure sensor 324, and an occlusion alarm unit 380. The
drug-delivery tube 308 is adapted to contain therein a drug 328
having a variable commanded flow rate and is disposable to deliver
the drug 328 to a patient 336. The pressure sensor 324 has an
output signal 338 and is adapted to sense internal pressure of the
drug-delivery tube 308. The occlusion alarm unit 380 is operatively
connected to the output signal 338 of the pressure sensor 324 and
has a variable pressure alarm setting to alert a user of an
occluded drug-delivery tube 308 when the output signal 338 of the
pressure sensor 324 exceeds the variable pressure alarm setting.
The occlusion alarm unit 380 changes the variable pressure alarm
setting based at least in part, and directly or indirectly, on the
variable commanded flow rate of the drug 328. In one example, the
occlusion alarm unit 380 includes the previously-described memory
326 and processor 344 of a procedure-room-unit host controller
(such as previously-described host controller 204) and alerts the
user through a popup window on a monitor (such as
procedure-room-unit monitor 441, as shown in FIG. 48). In another
example, not shown, the occlusion alarm unit does not involve a
processor of a procedure-room-unit host controller.
[0255] A fourth expression of the embodiment of FIG. 59 is for a
drug-delivery infusion pump subassembly 382 including a
drug-delivery tube 308, peristaltic pump fingers 372, a pressure
sensor 324, and an occlusion alarm unit 380. The drug-delivery tube
308 is adapted to contain therein a drug 328 and is disposable to
deliver the drug 328 to a patient 336. The peristaltic pump fingers
372 are disposed to interact with the drug-delivery tube 308 and
are controllable to pump the drug 328 at a commanded flow rate. The
pressure sensor 324 has an output signal 338 and is adapted to
sense internal pressure of the drug-delivery tube 308 downstream of
the peristaltic pump fingers 372. The occlusion alarm unit 380 is
operatively connected to the output signal 338 of the pressure
sensor 324 and has a variable pressure alarm setting to alert a
user of an occluded drug-delivery tube 308 when the output signal
338 of the pressure sensor 324 exceeds the variable pressure alarm
setting. The occlusion alarm unit 380 changes the variable pressure
alarm setting based entirely, and directly, on the variable
commanded flow rate of the drug.
[0256] In one implementation of the fourth expression of the
embodiment of FIG. 59, the drug-delivery tube 308, the peristaltic
pump fingers 372, the pressure sensor 324, and the occlusion alarm
unit 380 are components of a procedure room unit of a medical
effector system (such as the procedure room unit 200 of the
previously-described medical effector system 100'). In one example
of the fourth expression of the embodiment of FIG. 59, the
occlusion alarm unit 380 includes the previously-described memory
326 and processor 344 and alerts the user through a popup window
and/or a flashing visual alarm displayed on a monitor (such as
procedure-room-unit monitor 441, as shown in FIG. 48) and/or
through a noise alarm. In another example, not shown, the occlusion
alarm unit does not involve a processor of a procedure-room-unit
host controller and operates independently of, and in the absence
of, the previously-described procedure room unit 200.
[0257] It is noted that implementations, employments,
constructions, etc. of the first expression of the embodiment of
FIG. 59 are equally applicable to any one or more or all of the
second through fourth expressions of the embodiment of FIG. 59. In
one example of one or more or all of the expressions of the
embodiment of FIG. 59, the patient 336 receiving the drug 328 is
better controlled by having the occlusion pressure alarm setting
change based on the variable commanded flow rate of the drug 328.
Better control is achieved because the response time to an
occlusion, and any bolus buildup, will be minimized compared to
using a conventional fixed very-high occlusion pressure alarm
setting for all commanded flow rates of the drug. It is also noted
that such conventional alarm setting had to be higher than that
corresponding to the highest actual flow rate of the drug (which is
least used) because the internal pressure of a non-occluded
drug-delivery tube increases with increasing actual flow rate of
the drug, as can be appreciated by those skilled in the art. It is
further noted that with such high conventional fixed alarm setting
it would take much longer for a low commanded flow rate to generate
enough internal pressure in an occluded drug-delivery tube to cause
an occlusion alarm, and once such high internal pressure were
released, a large bolus of drug would be sent to the patient as
well.
[0258] The following paragraphs present a detailed description of
one particular enablement of the embodiment of FIGS. 41-57. It is
noted that any feature(s) of this particular enablement can be
added to any of the previously-described expressions (including
examples, etc. thereof) of the embodiment of FIGS. 41-57. In this
enablement, the PRU 200 is the main interface between the SDS 100
and the care team member responsible for administering drug(s). The
PRU 200 is designed for use in the procedure room. The PRU 200
connects to the BMU 300 by means of an Umbilical Cable 160. The PRU
200 accepts input from all physiologic signals provided by means of
the BMU 300 as well as from the Nasal Capnometer Module 140 and
Oral Capnometer Module 202 located within the PRU 200. The PRU 200
accepts user-input parameters such as patient data, drug dose rate
targets, and alarm trigger settings. The PRU 200 processes these
physiologic signals and user-input parameters; displays the
physiologic signals, derivations of these signals, and related
alarm status for user observation; and performs drug delivery and
oxygen metering in accordance with algorithms driven by these
signals.
[0259] Dosage Controller (DC) is a drug delivery algorithm utilized
by the PRU 200 and is an enhancement of Dose Rate Control (DRC).
The enhancement includes the algorithm's ability to calculate the
appropriate loading dose, which is based upon drug labeling
guidelines. For a given maintenance rate, the DC calculates an
appropriate loading dose that permits the rapid achievement of the
sedation effect at the initiation of the medical procedure.
[0260] The PRU 200 incorporates interactive software called the
monitoring shell, which monitors and displays the patient condition
and makes decisions about the patient status and resultant drug
delivery schedule. The monitoring shell utilizes algorithms to
quantify patient status, control drug delivery rate and oxygen
delivery rate, and presents alarms to the user. The monitoring
shell utilizes a broad array of input parameters including DC data,
patient physiologic monitoring data, patient physical data, and
alarm trigger settings. The monitoring shell reduces or stops drug
delivery, along with alerting the user, if it detects certain
undesired patient sedation condition(s). It will resume drug
delivery if such undesired patient sedation conditions are
subsequently corrected. The drug dose rate is based on user-input
parameters, such as the recommended dose rate and patient weight,
and software-based decisions in accordance with applied
pharmacologic principles. The oxygen delivery rate is based on
user-input parameters along with patient physiologic monitoring
data such as oxygen saturation level.
[0261] The PRU 200 incorporates an intuitive display screen
presentation that is called the PRU Graphical User Interface (PRU
GUI) 210. The PRU GUI 210 displays the status of the patient in
terms of physiologic parameters and alarms/alerts; it also presents
the functionality status of internal sensors and operational data.
The PRU GUI 210 also provides a simple intuitive means for the user
to input parameters such as patient data, drug dose rate, and alarm
trigger levels. One feature of the PRU GUI 210 is the PRU
intelligent alarm box 249 which allows the user to rapidly
ascertain the patient's general condition by means of the colors
Green, Yellow, and Red. The PRU intelligent alarm box 249 utilizes
algorithms to calculate and present a robust broadly defined status
of the patient.
[0262] Besides the DC, the monitoring shell, and PRU GUI 210, the
PRU 200 incorporates other software-driven operations. These
operations include monitoring functions and convenience functions.
The convenience functions include an auto-prime that provides
automatic infusion line 224 priming when the cassette 251 and drug
vial 250 have been installed into PRU 200. The monitoring functions
include an infusion line priming interlock that allows infusion
line 224 priming when the T-site luer 269 is attached to the T-site
base 271 of the cassette 251. The monitoring functions also include
oxygen delivery when connected to the patient and drug delivery
when a cassette 251 is not recognized by the PRU as previously
utilized in the PRU.
[0263] The PRU 200 includes an uninterruptible power supply (UPS)
214, a PRU console 444, and a PRU monitor 441. These items are
stacked in the order described and typically reside upon an SDS
cart 101 or upon the user's own platform.
[0264] The UPS 214 converts AC wall-outlet power to a low voltage
power that provides all of the electrical energy utilized by the
PRU console 444. The primary portion of the UPS 214 power that is
fed to the PRU console 444 is utilized by the PRU console 444,
while the remainder of the power is fed, via the PRU console 444,
to the PRU monitor 441 and to the BMU 300. The UPS 214 also has a
rechargeable battery backup subsystem, which is utilized, as a
temporary power source that is automatically invoked by the UPS 214
when there is an outage of AC wall-outlet power otherwise provided
via an AC power cord. The UPS 214 also provides the PRU console 444
with an earth connection for electrical grounding. There is
communications means between the UPS 214 and the PRU console 444
that conveys information regarding power status and battery status
related features. The power, communications, and the earth
connection are conveyed to the PRU console 444 by means of a low
voltage power cord, called the UPS output cable 490, that is
integral to the UPS 214 whereby the UPS output cable connector 491,
located on the end of this UPS output cable 490, is plugged into
the PRU console 444.
[0265] The UPS 214 includes an external AC power cord, universal
AC/DC power module 501, UPS power management circuit board 502, and
UPS rechargeable battery pack 503. The UPS 214 has an externally
located UPS on/off switch 504, an UPS power status indicator 505 to
display power status, and an UPS battery status indicator 506 to
indicate battery charge status.
[0266] UPS 214 further includes cooling fans 507 which are located
to the rear of UPS chassis 508. A decorative front bezel 509
attaches to UPS chassis 508 and UPS top cover 473. UPS top
E-PAC.TM. 474 and bottom E-PAC.TM. 475 are foam structures that
function to secure all UPS internal components.
[0267] The UPS 214 incorporates electrical circuitry that permits
the UPS output cable connector 491 to be detached from the PRU
console 444 while power is flowing while helping to prevent
electrical contact sparking or undue electrical stress to the
connector. The UPS output cable connector 491 also incorporates
means to assure that the earth connection contacts are the first
contacts to be made during the UPS-to-PRU connection and these are
the last contacts to open during disconnection.
[0268] The PRU monitor 441 provides the user with an interface to
the PRU 200 that combines a color PRU monitor display 442, PRU
monitor touchscreen 443 user interface, and PRU monitor speakers
458 and 459. The PRU monitor 441 is seated upon the top of the PRU
console 444. The PRU monitor 441 is provided power and earth
connection by the PRU console 444. Video and audio signals are also
provided by the PRU console 444. The PRU monitor 441 sends PRU
monitor touchscreen 443 signals to the PRU console 444.
[0269] The PRU monitor 441 is electrically attached to the PRU
console 444 by means of a PRU monitor cable that is plugged into
the rear of the PRU console 444. This cable provides the conveyance
means for power, earth connection, video, audio, and PRU monitor
touchscreen 443 signals. The PRU monitor cable connector 463 also
incorporates means to assure that the earth connection contacts are
the first contacts to be made during connection and the last
contacts to open during disconnection.
[0270] The PRU console 444 is the central computational and process
control resource of the SDS 100. The PRU console 444 also contains
specific functions including the drug infusion; patient CO.sub.2
gas analysis by means of capnometry; supplemental oxygen flow
control; barcode reading of cassette 251, oral/nasal cannula 145,
and drug vial 250 barcode label(s) that is located upon the item or
its packaging; patient data hardcopy printing; communications
within the SDS 100; communications to external resources; and power
control/management.
[0271] The PRU console 444 includes a PRU power management board
453, PRU processor board 452, system I/O board 451, barcode reader
module assembly 455, PRU printer 454, IV (intravenous) pump module
220, oxygen manifold 206, control buttons and lighted indicators,
external user connectors, and PRU console fan 456. All of these
items are enclosed within a single cabinet shroud. The PRU
processor board 452 and the system I/O board 451, which are linked
together with a flexible circuit wire harness, are together
referred to as the PRU host controller 204.
[0272] The PRU power management board 453 accepts the UPS 214 power
entering the PRU console 444 and converts it to several lower
voltage regulated outputs for use by the PRU 200 and the BMU 300.
In one example these regulated outputs include 5V (volts), 12V, and
15V.
[0273] The PRU processor board 452 provides the primary computation
resource for the SDS 100 and is one of the primary resources for
signal input/output. The majority of the SDS 100 software,
including the DC and the monitoring shell, reside in non-volatile
memory located on the PRU processor board 452. The PRU processor
board 452 includes a central processing unit (CPU), RAM Memory,
disc-on-chip memory, and an assortment of digital I/O, analog I/O,
video, and audio circuitry.
[0274] A flexible circuit wire harness provides interconnection
between about one hundred signal input/output lines of the PRU
processor board 452 and the system I/O board 451. It includes a
multi-dimensional flex print circuit board incorporating about ten
connectors.
[0275] The system I/O board 451 is a multi-functional circuit board
that integrates and processes signals from most circuits located
within the PRU console 444 including the PRU processor board 452,
IV pump module 220, PRU printer 454, barcode reader module 455, and
a diversity of operational circuits on the system I/O board 451
itself. It also processes signals involving other sources outside
the PRU console 444 such as signals from the UPS 214, BMU 300, and
PRU Monitor 441.
[0276] The system I/O board 451 has circuitry resident upon the
board itself. The system I/O board 451 also contains modules that
are mounted upon the board such as the nasal capnometer module 140
and oral capnometer module 202 and a flash memory module 466.
[0277] Numerous system I/O board 451 functional circuits are
described in the following paragraphs.
[0278] The flash memory module 466 is detachable, user accessible,
and provides for upgrades to the SDS 100 internal memory in order
to revise software for system operation.
[0279] There is a nasal capnometer module 140 and an oral cap
nometer module 202, which are mounted to and are a part of the
system I/O board 451. The nasal capnometer module 140 monitors the
patient's combined nasal exhale. The oral capnometer module 202
monitors the patient's oral exhale. Each capnometer module 140 and
202 includes a suction pump control circuit that controls a suction
pump, located independent from the system I/O board 451, that draws
in the patient sample in a controlled sample flow rate. Each
capnometer module 140 and 202 includes sample line pressure sensors
that monitor sample line pressure to detect sample line occlusions
and to compensate CO2 measurements in accordance with sample line
barometric pressure. Both capnometer modules 140 and 202 have their
own software, which provides for automatic calibrations as needed,
communications with the PRU host controller 204, and other
functions. There are a first and second capnometer I/O circuit that
reside on the system I/O board 451 and serve as the interface
between the respective capnometer module 140 and 202 and the PRU
processor board 452. One function of this circuitry is to control
power to the capnometer module 140 and 202 electronics and the
motors of capnometer pumps 141 and 142 in accordance with PRU
processor board 452 commands.
[0280] The fast switch circuit resides on the system I/O board 451
and provides for control of power that is applied to the PRU
umbilical cable electrical receptacle 461. This circuit helps
prevent sparking due to connect/disconnect of otherwise electrified
receptacles and disconnects power to umbilical cable 160 connector
pins that may be exposed during disconnection.
[0281] The PRU state circuit 510 works in conjunction with a
similar state circuit, the BMU state circuit 600 in the BMU 300,
whereby both state circuits 510 and 600 interact via the umbilical
cable 160 communication means. The PRU state circuit 510 in the PRU
console 444 provides the means for the PRU console 444 to be aware
of whether the umbilical cable 160 is plugged into the BMU 300 and
whether the BMU 300 is energized or off. This state status
information is utilized by the PRU console 444. For example, if the
PRU 200 is off and if the BMU 300 is on, then the BMU 300 is
attached via the umbilical cable 160 to the PRU 200 and the PRU 200
will automatically turn itself on. Another use for the state status
is to prevent umbilical cable 160 communications alarms related to
intentional disconnection of the umbilical cable 160. Yet another
role of the state status in the PRU 200 is to help control when
power is applied to the PRU umbilical cable electrical receptacle
461 in order to help avoid application of power to the exposed pins
of an unplugged umbilical cable 160.
[0282] An IV pump power control circuit controls power to the IV
pump module 220 in accordance with various commands from the PRU
processor board 452 and from interlocks such as the
controller-monitoring module 467 circuit. Also included in this
circuit is a stop drug button 497 which forces shutdown of power to
the IV pump module 220 and also communicates the status of this
button to the PRU processor board 452. Also included in this
circuit is a pump door button 496, which communicates the status of
this button to the PRU processor board 452 and also assists with
the control of the door latch solenoid 222 that unlocks the pump
door 201. Yet another function of this circuit is to convey the
signal status of the IV pump motor encoder to the PRU processor
board 452.
[0283] A PRU power button circuit monitors the power button 495,
which communicates the status of this button to the PRU processor
board 452. The PRU power button circuit also includes an LED
indicator driver circuitry that provides a ramping current to the
LED indicator of the PRU power status indicator 498 while in the
standby mode which produces a variable luminous indication during
standby. When in the On mode, this circuit drives the LED indicator
of the PRU power status indicator 498 with a continuous
current.
[0284] A PRU printer circuit provides electrically isolated
controlled power for the PRU printer 454 and also provides
electrically isolated communications between the PRU processor
board 452 and the PRU printer 454. A barcode reader circuit
provides controlled power for the barcode reader module 455 and
also provides a communications interface for the barcode reader
module 455 to the PRU processor board 452. A PRU fan control
circuit controls power to the PRU console fan 456. This circuit is
able to detect a slow running or stalled PRU console fan 456 and
then issue an alert to the PRU processor board 452.
[0285] A PRU temperature sensor circuit incorporates a thermal
sensor and signal processing that monitors the internal temperature
of the PRU console 444 and presents that temperature data to the
PRU processor board 452. This thermal sensor, along with associated
support circuitry, is located on the system I/O board 451 where it
can effectively monitor the thermal status inside the PRU Console
444.
[0286] The controller-monitoring module 467 is a monitor circuit
that monitors the viability of the PRU host controller 204 and
associated software programs it is running. If the
controller-monitoring module 467 detects undesired PRU host
controller 204 function (including in terms of too frequent or
infrequent processor activity), the controller-monitoring module
467 will notify the PRU processor board of this condition and the
controller-monitoring module 467 will take direct action to disable
the IV pump module 220 and shut down most functions within a short
period of time. In the event of a controller-monitoring module 467
detectable event, the controller-monitoring module 467 will also
temporarily sound a buzzer that is located on the PRU system I/O
board 451, as a means to notify the user of the undesired
condition.
[0287] A PRU monitor control circuit controls power to the PRU
monitor 441. It is controlled by the PRU processor board 452 and
the circuit includes a current limiting function. A PRU audio
amplifier circuit includes two audio amplifier circuits that accept
low level audio from the PRU processor board 452 and amplify these
signals. These amplified signals are utilized to drive the two PRU
monitor speakers 458 and 459 in the PRU monitor 441. The monitor
control circuit includes conveyance of a PRU monitor speaker
interlock signal to the PRU processor board 452 which helps assure
that the SDS 100 only operates if the PRU monitor speakers 458 and
459 are connected to the PRU console 444.
[0288] A modem circuit provides a means for the SDS 100 to
communicate with non-SDS devices via a telephone line. This circuit
implements isolated circuitry. An Ethernet circuit provides a means
for the SDS 100 to communicate with non-SDS devices via an Ethernet
line. This circuit also implements isolated circuitry.
[0289] PRU UPS communications interface is a circuit that provides
the interface between the UPS communications lines and the PRU
processor board 452.
[0290] A supplemental oxygen control circuit provides the basic
signal processing interface between the PRU processor board 452 and
supplemental oxygen related sensors. The sensors include the oxygen
sensor 482, the high side oxygen pressure sensor, the low side
oxygen pressure sensor, and the differential pressure sensor. One
of these sensors, the differential pressure sensor, is physically
located on the system I/O board 451 in the vicinity of this
circuit, while the other listed sensors are located on the oxygen
manifold 206. The supplemental oxygen control circuit also provides
power signals that drive the variable-size-orifice (VSO) flow
restrictor 480 (such as a VSO solenoid), which regulates
supplemental oxygen flow. Included features are electrical control
of the VSO flow restrictor 480 and the signal processing interface
between the PRU processor board 452 and the VSO flow restrictor
480. Yet another role of the supplemental oxygen control circuit is
to control the oxygen sampling solenoid in accordance with commands
received from the PRU processor board 452.
[0291] The last-to-be-discussed system I/O board 451 functional
circuit is the voltage monitoring circuit. The voltage monitoring
circuit provides an interface between the PRU processor board 452
and the various power supply voltages resident on the system I/O
board 451 in order to monitor those voltages and determine if they
are in desired ranges.
[0292] There is a nasal capnometer pump 141, located within the PRU
console 444, which is plumbed, but not physically affixed, to the
nasal capnometry module 140. There is an oral capnometer pump 142,
located within the PRU console 444 which is plumbed, but not
physically affixed, to the oral capnometry module 202.
[0293] The barcode reader assembly 455 incorporates a
self-contained barcode reader module 464 that is mounted on a metal
frame that includes a mirror. The metal frame is mounted inside the
housing of PRU console 444 in an orientation that allows the
projection of the barcode laser beam through an open window of the
housing of the PRU console 444 to shine upon an area external to
the PRU console 444. The user places the barcode of the packaging
containing the oral/nasal cannula 145 or cassette 251 or drug vial
250 within reading range of the active barcode reader module 464
laser beam. The barcode reader module 464 then reads the
barcode.
[0294] The PRU printer 454 includes a thermal print head, a paper
feed mechanism, a printer driver board, and a PRU printer door 460.
This assembly is mounted to the housing of the PRU console 444
utilizing electrically isolated means that helps provide for an
electrically isolated access to the printer paper roll.
[0295] The IV pump module 220 provides the drug pumping function of
the PRU console 444. The IV pump module 220 accepts the disposable
cassette 251. The IV pump module 220 propels metered drug(s)
through the cassette 251 via peristaltic massage of the flexible
tube 277. The IV pump module 220 detects the presence of the T-site
commercial luer 269 placement into the respective receptacle of
cassette 251 and also detects drug vial 250 seating upon the
respective receptacle of the cassette 251. The IV pump module 220
incorporates several features such as detection of air-in-line and
occlusion of the downstream fluid path. Another function of the IV
pump module 220 is the pump door 201 and the controlled opening of
the pump door 201.
[0296] The IV pump module 220 includes an IV pump housing 239 that
has attached to it the pump door 201, the pump door latch 205 and
the pump door lifting mechanism 207, IV pump assembly 232, IV pump
control board 233, an optical sensor board, and air-in-line sensor
225. The IV pump assembly 232 includes an IV pump motor, a pump
finger mechanism, an IV pump motor encoder, downstream IV pressure
sensor 223, and an IV pump sensor board. The optical sensor board
227 has the T-site sensor 226 and the vial sensor 228. These two
sensors protrude through the IV pump housing 239 in the vicinity of
the pump cassette deck 221 where they interact with the associated
mechanisms of the seated disposable cassette 251. The optical
sensor board also has a door latch solenoid 222 that, when
activated, presses upon the pump door latch 205 to release the pump
door 201, whereby the pump door 210 is lifted by pump door lifting
mechanism 207 and proceeds to the open position to expose the
cassette deck 221 and permit the user access for installation or
removal of the cassette 251.
[0297] The oxygen manifold 206 is the primary component of the
supplemental oxygen delivery subsystem of the PRU console 444. The
oxygen manifold 206 provides a path for oxygen flow, oxygen flow
control, oxygen purity evaluation, and oxygen overpressure relief.
It is mounted at the rear section of the PRU console 444.
[0298] The oxygen manifold 206 includes a manifold that is equipped
with the following items that are encountered by incoming oxygen
gas in the order listed: externally located oxygen input coupler
484, high side pressure relief valve 485 and associated exhaust
port, high side pressure sensor 487, oxygen diverter 492, fixed
restrictor 489, VSO flow restrictor 480, low side pressure sensor
488, low side pressure relief valve 486, and oxygen main output
outlet. Ancillary gas paths include an oxygen sample solenoid 481,
oxygen sensor 482, and oxygen sensor exhaust port 483. There are
also outlets for plumbing gas pressure from each side of the fixed
restrictor 489 to the differential pressure sensor 479 which is
located on the system I/O board 451. The oxygen manifold 206 has an
oxygen input coupler 484 that protrudes from the rear of the PRU
console 444 for user connection to an external supply of
supplemental oxygen.
[0299] The oxygen manifold 206 has a flow path that intercepts an
oxygen sample. The oxygen sample is gated by an oxygen sample
solenoid 481 to temporarily allow flow of supplemental oxygen past
the attached oxygen sensor 482. The oxygen manifold 206 has an
oxygen sensor exhaust port 483 that permits the sampled gas to be
expelled from the oxygen manifold 206.
[0300] The oxygen manifold 206 utilizes a high side pressure relief
valve 485 that protects the oxygen high pressure path from
excessive high supply pressure by relieving that pressure via the
exhaust port of the high side pressure relief valve 485. The oxygen
manifold 206 utilizes a low side pressure relief valve 486 that
protects the oxygen low pressure path from excessive output
pressure by relieving any excessive pressure via the exhaust port
of the low side pressure relief valve 486.
[0301] The oxygen diverter 492 is a manually operated valve and is
operated via an externally accessible oxygen diverter knob 493.
This oxygen diverter 492 can be set to the normal position whereby
the supplemental oxygen flow is only directed through the regulated
flow path of the SDS 100 system. The oxygen diverter 492 can
alternately be set to the SDS-system-bypass position, whereby the
supplemental oxygen flow no longer flows through the regulated flow
path of the SDS 100 system. Instead, it flows exclusively directly
to an externally accessible barbed oxygen outlet 494 that provides
the user with a convenient means to connect a user-provided
SDS-system-bypass oxygen delivery device.
[0302] The PRU console 444 provides a direct means for user input
via the PRU power button 495, the stop drug button 497, and the
pump door button 496. The PRU power button 495 allows the PRU 200
to be placed into standby or ready mode. The stop drug button 497
allows the user to halt drug(s) delivery by cutting off power to
the IV pump module 220. The pump door button 496 allows the user to
open the pump door 201 when there is no cassette 251 installed in
the IV pump module 220 or when the cassette 251 is present and the
T-Site commercial luer 269 is installed into the cassette 251.
[0303] The PRU console 444 provides the user with status
indications by means of two illuminated indicators. One of these
indicators is the PRU power status indicator 498, which is integral
to the PRU power button 495. This indicator has a periodic
fluctuating brilliance when in standby mode and a continuous
brilliance in the ready mode. The other indicator is the pump door
locked indicator 499 which is integral to the pump door button 496,
which is lit when the pump door 201 is locked, and which is not lit
when the pump door 201 is not locked.
[0304] The PRU console 444 has several externally user accessible
connectors. The PRU umbilical cable electrical receptacle 461,
located on the front panel of the PRU console 444, is a connector
for providing convenient electrical connections to umbilical cable
160. It utilizes various pin heights to provide hot switching
without degradation of pins. The PRU umbilical cable pneumatic
receptacle 462, located on the front panel of the PRU console 444,
is a connector for providing convenient simultaneous multiple
pneumatic connections to umbilical cable 160 including pneumatic
paths for oxygen delivery and patient exhale samples. The modem
connector 470, located on the rear panel of the PRU console 444, is
a type RJ11 connector for providing user connection to an external
telephone line. The Ethernet connector 471, located on the rear
panel of the PRU console 444, is a type RJ45 connector for
providing user connection to an external Ethernet line. The PRU
power connector 465, located on the rear panel of the PRU console
444, is a connector for providing user connection of PRU console
444 to UPS output cable connector 491.
[0305] The PRU console 444 has a fan referred to as the PRU console
fan 456. The PRU console fan 456 provides thermal cooling of the
components located inside the PRU console 444. The PRU console fan
456 also provides for robust ventilation of the PRU console 444 as
a means to dilute any potentially present supplemental oxygen
entering the PRU console 444 thereby helping keep the oxygen
concentration within a desired range.
[0306] The internal components of PRU 200 are sandwiched between
top PRU foam support 447 and bottom PRU foam support 448. In one
example, PRU foam supports 447 and 448 are constructed of rigid
foam well known in the electronics industry as an E-PAC.TM.
chassis. Strategically located recesses and cavities in the
E-PAC.TM. chassis efficiently capture and securely hold pc boards,
pumps, LCD, speaker and other components. The outer housing of PRU
200 is constructed of rigid molded thermoplastic (e.g. ABS) and
includes top chassis 445, top bezel 446 and front bezel 450. Bottom
chassis 449 is constructed of sheet metal and forms part of the
outer housing of PRU 200. The housing components are held together
with molded-in snap features and screws. Top chassis 445 is
designed to be readily removable for access to the PRU 200.
[0307] PRU/BMU Interface
[0308] A fourth aspect of the invention is directed to a procedure
room unit (PRU) 200 and bedside monitoring unit (BMU) 300 interface
of a sedation delivery system 100 (or other type of
medical-effector system 100'), an embodiment of which is shown in
FIGS. 41-57 and 60-62. An expression of the embodiment of FIGS.
41-57 and 60-62 is for a sedation delivery system 100 (or other
type of medical-effector system 100') including a
microprocessor-based bedside monitoring unit 300 (an embodiment of
which is shown in FIGS. 41 and 60-62), a microprocessor-based
procedure room unit 200 (an embodiment of which is shown in FIGS.
41-57), and an umbilical cable 160 (an embodiment of which is shown
in FIGS. 41, 42, 60 and 61). The bedside monitoring unit 300 has a
bedside-monitoring-unit host controller 301, has a first series of
connection points for receiving patient inputs from patient
monitoring connections, has a second series of connection points
for outputting patient outputs based on the received inputs, and
has a display screen for displaying at least some of the patient
outputs. The procedure room unit 200 has a drug-delivery flow
control assembly 220' (or other type of medical effector 220'') and
has a procedure-room-unit host controller 204. The
procedure-room-unit host controller 204 has a memory containing a
patient-monitoring and drug-delivery-scheduling program (or other
patient-monitoring and medical-effector-scheduling program). The
program is operatively connected to program inputs based at least
in part on at least some of the patient outputs and controls,
and/or advises a user to control, the drug-delivery flow control
assembly 220' (or other medical effector 220'') based at least in
part on the program inputs. The umbilical cable 160 has a first end
attached or attachable to the second series of connection points of
the bedside monitoring unit 300 and has a second end attached or
attachable to the procedure room unit 200. At least one of the
first and second ends is detachable from the corresponding bedside
monitoring unit 300 or the procedure room unit 200. The
procedure-room-unit host controller 204 and the
bedside-monitoring-unit host controller 301 are operatively
connected together when the umbilical cable 160 is attached to the
procedure room unit 200 and the bedside monitoring unit 300.
[0309] In one arrangement of the expression of the embodiment of
FIGS. 41-57 and 60-62, the drug-delivery flow control assembly 220'
includes a drug-delivery infusion pump assembly 220 such as a
peristaltic pump assembly. In one variation of this arrangement,
the drug(s) is delivered to the patient through an IV. In another
arrangement, not shown, the drug-delivery flow control assembly
includes a gaseous-drug gas flow controller. In one variation of
this arrangement, the gaseous drug(s) is oxygen and/or a non-oxygen
gas and is delivered to the patient through a cannula assembly.
[0310] In one example of the expression of the embodiment of FIGS.
41-57 and 60-62, the procedure room unit 200 has an individual
procedure-room-unit (PRU) identifier and the bedside monitoring
unit 300 has an individual bedside-monitoring-unit (BMU)
identifier. The procedure-room-unit host controller 204 of the
procedure-room unit 200 compiles an electronic history of the
bedside monitoring unit 300 when attached to the procedure room
unit 200 based on the individual BMU identifier. In one variation,
the identifiers reside in the host controllers of the PRU and BMU,
and the electronic history is automatically compiled when the BMU
is attached to the PRU. In one extension, the sedation delivery
system 100 also includes a single-patient-use drug-delivery
cassette assembly 251 and a single-patient-use cannula assembly 145
and a single-patient-use drug vial 250. The drug-delivery cassette
assembly 251 has an individual cassette identifier and is
operatively connectable to the drug-delivery flow control assembly
220' of the procedure room unit 200. The cannula assembly 145 has
an individual cannula identifier and is attachable to the bedside
monitoring unit 300. The drug vial has an individual vial
identifier and is operatively connectable to the drug-delivery
cassette assembly 251. The procedure-room-unit host controller 204
of the procedure-room unit 200 compiles an electronic history of
the drug-delivery cassette assembly 251 and the cannula assembly
145 and drug vial 250 based on the individual cassette and cannula
and vial identifiers (the SPU identifiers).
[0311] In a further expression of the embodiment of FIGS. 41-57 and
60-62, the procedure room unit 200 downloads has an individual
procedure-room-unit (PRU) identifier and the bedside monitoring
unit 300 has an individual bedside-monitoring-unit (BMU)
identifier. The procedure-room-unit host controller 204 of the
procedure-room unit 200 compiles an electronic history of the
bedside monitoring unit 300 when attached to the procedure room
unit 200 based on the individual BMU identifier.
[0312] In a further expression of the embodiment of FIGS. 1-57 and
60-62, the drug cassette assembly 251 individual cassette
identifier is a unique barcode of a sterile package containing the
drug cassette assembly 251 and/or a barcode on the drug cassette
assembly 251. The cannula assembly 145 individual cannula assembly
identifier is a unique barcode of a sterile package containing the
cannula assembly 145 and/or a barcode on the cannula assembly 145.
The drug vial 250 individual vial identifier is a unique barcode of
a sterile package containing the drug vial 250 and/or a barcode on
the drug vial 250. The unique identifiers are read at PRU 200 using
barcode reader 455.
[0313] In one enablement of the expression of the embodiment of
FIGS. 41-57 and 60-62, when the bedside monitoring unit 300 is
attached to the procedure room unit 200, the electronic history of
the cassette, cannula and vial identifiers is passed on to BMU 300.
The BMU 300 updates its electronic history of SPU identifiers so
previously used SPUs cannot be used again with that particular BMU.
In a further enablement, the BMU 300 also copies its history of SPU
identifiers to PRU 200. This is particularly useful in surgical
procedure suites that have multiple BMUs and fewer PRUs. The cross
copy of SPU identifiers between BMUs and PRUs further prevents
multiple use of SPUs on different PRUs within a surgical suite.
[0314] In one enablement of the expression of the embodiment of
FIGS. 41-57 and 60-62, when the bedside monitoring unit 300 is
attached to the procedure room unit 200, the
bedside-monitoring-unit host controller 301 of a turned-on bedside
monitoring unit 300 turns on a turned-off procedure room unit 200.
In the same or a different enablement, when the bedside monitoring
unit 300 is attached to the procedure room unit 200, the
procedure-room-unit host controller 204 of a turned-on procedure
room unit 200 turns on a turned-off bedside monitoring unit 300. In
one variation, when a PRU 200 or a BMU 300 is turned on, its host
controller 204 and 301 boots up.
[0315] In one illustration of the expression of the embodiment of
FIGS. 41-57 and 60-62, the bedside monitoring unit 300 displays
patient monitoring while not attached to the procedure room unit
200 and displays patient monitoring while attached to the procedure
room unit 200 when the procedure-room-unit host controller 204
detects certain faults in the procedure room unit 200. In the same
or a different illustration, the procedure-room-unit host
controller 204 shuts off the drug-delivery infusion pump assembly
220 when certain faults are detected in an attached bedside
monitoring unit 300 and/or in the procedure room unit 200.
[0316] In one implementation of the expression of the embodiment of
FIGS. 41-57 and 60-62, the umbilical cable 160 includes a power
feed line, and the procedure-room-unit host controller 204 shuts
off power to the power feed line of the umbilical cable 160 when
the umbilical cable 160 is disconnected from the bedside monitoring
unit 300 and/or the umbilical cable 160 is disconnected from the
procedure room unit 200. In one variation, the bedside monitoring
unit 300 includes a bedside-monitoring-unit battery 303, and power
from the procedure room unit 200 charges the
bedside-monitoring-unit battery 303 via the power feed line of the
umbilical cable 160.
[0317] Bedside Monitoring Unit
[0318] A fifth aspect of the invention is directed to, or a
component of, or can be used by, a bedside monitoring unit (BMU)
300, an embodiment of which is shown in FIGS. 6, 41 and 60-62. A
first expression of the embodiment of FIGS. 6, 41 and 60-62 is for
a stand-alone patient monitoring device including a oral/nasal
cannula 145, a first series of connection points from receiving
input signals from patient monitoring connections and a connector
151 for receiving a supplemental O.sub.2 supply 152.
[0319] A second expression of the embodiment of FIGS. 6, 41, 60-62
is for a BMU 300 that accepts user inputs of patient and procedure
data including a graphic user interface 212. In this application,
BMU 300 may be used for inputting and displaying patient parameters
(such as physiological parameters) during a pre-procedure set-up, a
surgical procedure or during post-procedure recovery.
[0320] A third expression of the embodiment of FIGS. 6, 41, 60-62
is for a BMU 300 that provides for the delivery of audible commands
to patient 10 including a ARM module 340, an audible output through
oral/nasal cannula 145 and earpiece 135 vibratory handset 342 and
input cable 150.
[0321] In one implementation of the third expression, during a
pre-procedure set-up BMU 300 provides an audible command to patient
10 via ear piece 135, such as "squeeze left hand" and monitors the
response time to establish a baseline response rate. In one
illustration of the implementation cannula 145 provides for the
delivery of audible commands to a patient 10 requesting a response
for an Automated Responsiveness Monitor (ARM) 340.
[0322] A fourth expression of the embodiment of FIGS. 6, 41, 60-62
is for a BMU 300 in combination with a procedure room unit
including a oral/nasal cannula 145, a first series of connection
points from receiving input signals from patient monitoring
connections and a second series of connection points for outputting
patient parameters and a display screen for displaying patient
parameters. In one implementation of the fourth expression
umbilical cable 160 connects to BMU umbilical cable connector 151
(in lieu of connection to supplemental O.sub.2 supply 152) and
communicates patient parameters from BMU 300 to PRU 200. In one
illustration BMU 300 travels with patient 10 to a procedure area.
Umbilical cable 160 connects BMU to PRU 210 and BMU 300 downloads
all patient input data and parameters (inclusive of physiological
parameters and CO.sub.2 readings) to PRU 210. PRU 210 initiates
O.sub.2 delivery to the patient (as required) via cable 160.
[0323] In a fifth expression of the embodiment of FIGS. 6, 41, and
60-62, BMU 300 monitors user inputs of patient parameters and
includes patient information on graphic user interface 212 during
post-procedure recovery. In this application, BMU 300 may be used
for displaying patient parameters (such as physiological
parameters) during a post-procedure recovery, providing an O.sub.2
supply, if required and allowing medical personnel to assess the
condition of patient 10 prior to release. In one implementation of
the fifth expression, BMU 300 includes a light bar 208 of multiple
LEDs for easy viewing by medical personnel. Light bar 208 is able
to convey patient condition in different formats, such as green
lighting, red lighting and yellow lighting, blinking lights and
steady state lights.
[0324] In a second implementation of the fifth expression, BMU 300
utilizes ARM module 340 and ARM handset 342 to automatically query
the patient and record time-based responsiveness replies and
combine the responses with other monitored parameters to conduct
patient assessment.
[0325] The following paragraphs present a detailed description of
one particular enablement of the embodiment of FIGS. 6, 41 and
60-62. It is noted that any feature(s) of this particular
enablement can be added to any of the previously-described
expressions (including examples, etc. thereof) of the embodiment of
FIGS. 6, 41 and 60-62. In this enablement BMU 300 provides for
monitoring of patient physiologic parameters during all phases of a
procedure. When BMU 300 is connected to PRU 200 via umbilical cable
160 in the procedure room, the physiologic parameters monitored by
BMU 300 are displayed on PRU 200. BMU 300 contains BMU host
controller 301, which is the computer for the unit. BMU host
controller 301 includes both hardware and software components. The
hardware contains interface components for communicating with the
patient monitors. This communication includes receiving patient
data, monitoring operating status, and sending routine commands to
the modules. The software processes the data received from the
patient monitors for display on the visual display monitor. The
software contains drivers for the visual display monitor, touch
screen, speakers, ARM functions, internal memory, and printer. BMU
300 is designed to stay with the patient throughout the procedure
flow from the pre-procedure room to the procedure room and finally
to the recovery room.
[0326] BMU 300 contains electrocardiogram (ECG) module 330, which
contains electronics, and software used to process patient signals
as supplied through ECG pads 332 and ECG leads 334. ECG pads 332
and ECG leads 334 are well known in the medical. One example of ECG
module 330 is available from Mortara Instrument, Inc., Milwaukee,
Wis., Model M12A. The resultant data from this module are then sent
to BMU host controller 301 for display of patient physiologic
parameters (heart rate and wave form).
[0327] BMU 300 also contains non-invasive blood pressure (NIBP)
module 320. NIBP module 320 includes NIBP pump 322. One example of
NIBP module 320 is available from SunTech Medical Instruments,
Inc., Morrisville, N.C., Model MC2619045. Non-invasive blood
pressure (NIBP) module 320 contains the electronic components,
software, pump, and valves used to inflate non-invasive blood
pressure (NIBP) cuff 321. NIBP cuffs are well known in the medical
arts. The electronic components process the information received
through NIBP cuff 321 with software. The resultant blood pressure
data (systolic, diastolic pressures) are then sent to BMU host
controller 301.
[0328] Pulse oximeter (SpO.sub.2) module 310 is also contained
within BMU 300. One example of pulse oximeter module 310 is
available from Dolphin Medical, Inc., Hawthorne, Calif., Model
OEM701. Pulse oximeter module 310 contains the electronic
components and software used to process patient information
received through reusable pulse oximeter probe 311. One example of
pulse oximeter probe 311 is available from Dolphin Medical, Inc.,
Hawthorne, Calif., Model 210. The resultant data (pulse rate,
SpO.sub.2, and wave form) are sent to BMU host controller 301.
[0329] Also located within BMU 300 is automated responsiveness
monitor (ARM) module 340. Arm module 340 includes ARM speaker
assembly 341. During a procedure, ARM module 340, which includes
hardware and software, provides simultaneous audible and tactile
stimuli via earpiece 135 and a vibratory ARM handset 342 to the
patient. Arm handset 342 is ergonomically designed to fit
comfortably in the hand of the patient and held in the palm by a
retaining strap. The stimuli continue for up to a fixed period of
time, or until the patient responds by squeezing ARM handset 342
which activates a mechanical switch within the handset and sends a
signal to ARM module 340. The ARM audible stimulus is a request
("please squeeze your hand") and a mild vibration of ARM handset
342. If the patient fails to respond a more urgent audible request
is repeated ("squeeze your hand") and the vibration intensity is
increased, which may include an increase in audible volume. If the
patient again fails to respond an even more urgent audible request
is repeated ("squeeze your hand now") and ARM handset 342 vibration
intensity is increased a third and final time. If the patient fails
to squeeze ARM handset 342 during this sequence the patient is
deemed non-responsive. If the patient does not respond within the
fixed period of time, the monitoring shell takes action and alerts
the care team.
[0330] Oral/nasal cannula 145 attaches to the patient at one end
that includes three gas sampling ports, one for the left nostril,
one for the right nostril, and one for the mouth. The patient end
also includes nasal and oral outlets for oxygen delivery. The other
end of oral/nasal cannula 145 connects to BMU 300 via cannula
connector plate 304. Cannula connector plate 304 fluidly connects
outputs from oral/nasal cannula 145 with BMU 300. Cannula connector
plate 304 also connects outputs from BMU 300 with oral/nasal
cannula 145. Within BMU 300 is located a pressure transducer
(which, in one example, is a nasal pressure transducer 47) which
functions to detect when the patient is inhaling or exhaling and
communicates to PRU 200 to control oxygen flow. Oral/nasal cannula
145 also includes earpiece 135, which delivers audible respond
commands to the patient from ARM module 340.
[0331] A power button 318 is located on the face of BMU 300,
illuminates green when BMU 300 power is on, and pulses green when
BMU 300 is in standby mode. BMU 300 includes a user interface that
relays information gathered from the physiologic monitors and
sensors to the user and allows the user to enter information and
commands to the control system. BMU Graphic User Interface (GUI)
212 includes a backlit LCD visual display monitor with a touch
screen for user input and an alarm system with audio and video
components. Speaker 216, for providing audible indicators to the
user, is located on the face of BMU 300. A light bar 208 is located
on the top portion of BMU 300, is molded from a semi-transparent
thermoplastic (e.g., polycarbonate), and is illuminated by LED's
203 to provide visual indication of alarm conditions. The light bar
208 is particularly useful to convey information to medical
personnel in the post-procedure room where numerous patients may be
recovering from surgical procedures and numerous BMUs are present.
When patient physiology crosses alert and alarm thresholds, the
digital display indicates the alarm condition. In addition to the
visual indicators, the BMU incorporates distinct audible tones for
alarms. Light bar 208 may, for example, display or flash green when
the BMU 300 does not detect any abnormalities or display or flash
yellow when an alert occurs or display or flash red when an alarm
occurs. Further, light bar 208 may change color, intensity and
flashing cycle to portray ventilation magnitude and/or status.
Light bar 208 may also include alpha, numeric or alphanumeric
displays. Such displays may provide additional detailed information
such as heartbeats per minute, respiration rate or alarm
details.
[0332] A separate thermal printer may be used to create a hard copy
record of sedation information. Printer port 218 is provided on the
side of BMU 300 for connection of a remote printer. BMU 300 can
operate on either internal battery power by utilizing BMU batteries
303 or through an external a/c power adaptor. Further, BMU 300
receives power from PRU 200 when they are connected in the
procedure room. An oxygen adaptor 152 and tubing set can be
connected between BMU 300 and a standard oxygen wall outlet or
oxygen tank to allow oxygen to be conveniently provided to a
patient through BMU 300 when BMU 300 is not connected through
umbilical 160 to PRU 200 (typically pre-procedure and
recovery).
[0333] As best illustrated in FIG. 62, the internal components of
BMU 300 are sandwiched between top foam support 312 and bottom foam
support 313. In one example, foam supports 312 and 313 are
constructed of rigid foam well known in the electronics industry as
an E-PAC.TM. chassis. Strategically located recesses and cavities
in the E-PAC.TM. chassis efficiently capture and securely hold pc
boards, pump, LCD, speaker, and other components. The outer housing
of BMU 300 is constructed of rigid molded thermoplastic (e.g., ABS)
and includes bottom 314, front 315, back 316, and top 317. The
housing components are held together with molded-in snap features
and screws. Housing top 317 is designed to be readily removable for
access to batteries 303.
[0334] Sedation Delivery System
[0335] Referring to FIGS. 63-76, the following paragraphs present
one combination of particular examples of the previously-described
aspects of the invention and is for a sedation delivery system
(SDS) 100, which is an integrated monitoring, and drug delivery
system and which is intended to provide a means of sedating a
patient during medical procedures. SDS 100 uses a drug delivery
algorithm called Dosage Controller (DC) and an intravenous infusion
pump 220 to deliver drug(s) with a variable rate infusion that
rapidly achieves and maintains a desired sedation effect. It
enables the physician/nurse (non-anesthesiologist) care team to
adjust the patient's sedation level by simply entering the dose
rate that they believe will maintain the desired sedation effect.
DC calculates the appropriate loading dose, based on the guidelines
in the drug labeling, that will rapidly achieve the sedation effect
for the given maintenance rate.
[0336] SDS 100 includes four routine physiologic monitors. These
are a pulse oximeter 110 for monitoring the patient's arterial
oxygenation, non-invasive blood pressure (NIBP) 120 and
electrocardiogram pads (ECG) 332 for monitoring the patient's
cardiodynamics, and a capnometer 140 and 202 for measuring the
patient's respiratory activity. In addition, SDS 100 has an
automated responsiveness monitor (ARM) 150 to aid the care team in
assessing the patient's level of sedation. All five monitors and DC
are integrated together through a software module referred to as
the monitoring shell. The monitoring shell is intended to keep the
patient at the desired level of sedation. It monitors the patient's
condition, keeps the care team informed of the patient's status,
and immediately stops the delivery of drug(s) if it detects an
undesired sedation condition. Under certain circumstances, the
monitoring shell will re-initiate drug delivery, but at a reduced
maintenance rate, once the patient's condition returns to a desired
sedation condition. The monitoring shell will not re-initiate
infusion if such inaction is warranted by the undesired sedation
condition. Instead, it requires intervention by a care team member
to re-initiate drug delivery following such a condition. An
integral part of the monitoring shell is procedure room unit (PRU)
Graphical User Interface (GUI) 210 and bedside monitoring unit
(BMU) graphic user interface 212; each displays the monitored
physiologic values in a fashion that enables the care team to
readily determine the status of the patient. The GUI has also been
designed to give the care team an efficient means of adjusting the
patient's level of sedation through changes in the maintenance
rate.
[0337] SDS 100 is designed to provide continuous hemodynamic
monitoring of the patient in the pre-procedure room, the procedure
room, and the recovery (post-procedure) room. It includes two main
units, which are the bedside monitoring unit (BMU) 300 and the
procedure room unit (PRU) 200. BMU 300 is connected to the patient
in the pre-procedure room and stays with the patient through
recovery. BMU 300 contains pulse oximeter module 310, NIBP module
320, ECG module 330, and ARM module 340. Once connected to the
patient, it monitors and displays the patient's arterial
saturation, arterial pressure, and heart rate. Supplemental oxygen
(which includes air having an enriched oxygen content) can be
delivered at this time through BMU 300 and oral/nasal cannula 145.
When the patient is wheeled into the procedure room, BMU 300 is
attached to PRU 200 by umbilical cable 160, which contains both
pneumatic and electrical lines. During the procedure, umbilical
cable 160 allows PRU 200 to receive patient physiologic data from
BMU 300 as well as the patient's respiratory gases. In addition,
umbilical cable 160 allows for delivery of oxygen to the patient
from PRU 200.
[0338] PRU 200 adds capnography to the system, monitoring and
displaying the patient's respiration rate and end-tidal CO.sub.2.
ARM monitoring is activated and the patient's responsiveness is
displayed to the care team. As soon as PRU 200 detects respiration
activity (from the capnometer), mandatory oxygen delivery is
initiated. All drug delivery is performed by PRU 200 as it contains
intravenous infusion pump 220, DC and the monitoring shell. Drug
infusion cannot be initiated until all monitors are connected and
providing valid values and oxygen is being delivered to the
patient. PRU 200 is the main interface between the care team member
responsible for administering sedation and SDS 100. It contains GUI
210 that displays the status of the patient and facilitates
adjustment of the patient's level of sedation.
[0339] Referring now to FIGS. 42 and 43, PRU 200 is a component of
the system that provides for: monitoring and display of patient
physiologic parameters; user input of patient data; user input of
dose rate; and hardware and software for delivery of drug(s) during
the procedure. PRU 200 is designed to stay in the procedure room
and is the mechanism for drug delivery.
[0340] Within PRU 200 are located two capnometers 140 and 202 used
for sampling CO.sub.2 from the areas in front of the patient's
mouth and nostrils. Software monitors respiratory activity and the
site with the greater respiratory activity is displayed to the
user. Sensors analyze the samples, and the resultant data
(respiratory rate, EtCO.sub.2, and respiration wave form) are sent
to PRU host controller 204.
[0341] Sedation Delivery System 100 is an apparatus for delivering
a sedative drug to a patient during a medical procedure. The amount
of sedative drug delivered to the patient is determined by the
level of patient responsiveness as measured by ARM system 340. In
an alternate embodiment, the level of pain a patient is enduring
determines the amount of sedative drug delivered to the patient.
Patient pain level can be indicated by physiological parameters,
such as, increased heart rate and/or blood pressure and/or brain
activity. Sedation Delivery System 100 includes the capability to
monitor heart rate through the ECG monitor and blood pressure by
way of the NIBP monitor. An EEG (brainwave) monitor is optionally
supplied with Sedation Delivery System 100 to monitor a patient's
brain activity. Sedation Delivery System 100 therefore interprets
an elevated output from the ECG, NIBP, and/or EEG as an indication
that the patient is experience pain or stress and adjusts the drug
delivery to better manage the patient. For example, Sedation
Delivery System 100 will increase drug flow to the patient or
notify the clinician to increase drug if any of ECG, NIBP, and/or
EEG monitors increase by a predetermined threshold, for example,
20% in a predetermined time period. Other monitored physiological
parameters are within the scope of this embodiment as is well
appreciated by those skilled in the art.
[0342] Referring to FIGS. 42 through 47, Infusion pump 220 is
located in the front portion of PRU 200 and provides for the
delivery of drug(s). Disposable cassette 251 interfaces with pump
220. Cassette 251 holds a drug vial 250 from which drug(s) is
delivered to the patient. Cassette 251 includes a base plate
holding vial spike 261, infusion tubing 277 & 259, and t-site
luer connector 269 located at the patient end of the infusion
tubing. As illustrated in FIG. 44, pump door 201 on PRU 200 opens
to accept cassette 251 and secures cassette 251 into proper
position with pump 220 when closed. T-site sensor 226 is an optical
type sensor located in Pump 220 that is used to signal PRU host
controller 204 of the presence of T-site 269 when cassette 251 is
installed. Another optical type sensor located in pump 220 is vial
sensor 228. It is used to signal PRU host controller 204 of the
presence of a drug vial 250. Air-in-line sensor 225 is an
ultrasonic device that straddles a short segment of tubing 277 and
detects the presence of air or air bubbles being pumped through
tubing 277 from the drug vial. Occlusion detector 223, located in
pump 220, is a small pressure transducer that rests against tubing
277 to detect an increase in the tubing internal pressure
indicating a possible occlusion in infusion tubing 259. Pump
fingers 229 interface with a segment of tube 277 located across the
top of cassette 251 and their peristaltic pumping action pumps
drug(s) from the drug vial 250 through tubes 277 & 259 and to
the patient. Pump 220 is driven by software on electronic circuit
boards that interface with PRU host controller 204.
[0343] FIG. 45 further illustrates the proper location of cassette
251 in pump 220 and shows pump door 201 open. FIG. 46 illustrates
cassette 251 in pump 220, door 201 closed, and a drug vial 250 in
position to be placed on vial spike 261. FIG. 47 illustrates
cassette 251 inserted into pump 220, door 201 closed, and a drug
vial 250 placed on vial spike 261.
[0344] Referring again to FIGS. 42 and 43, located within PRU 200
is oxygen delivery module 206, which controls the delivery of
oxygen to the patient during the procedure. Oxygen delivery module
206 contains sensors, flow control devices, and tubing that provide
for oxygen delivery. One of the sensors measures the concentration
of oxygen in the line coming into PRU 200, and, if the
concentration of oxygen is below a predetermined level, oxygen
delivery is not permitted and a message is displayed to the user.
This feature is intended to help prevent delivery of a gas other
than oxygen to the patient.
[0345] PRU graphic user interface (GUI) 210 allows PRU 200 to relay
information gathered from the physiologic monitors and sensors to
the user and allows the user to enter information and commands. PRU
graphic user interface 210 includes a visual display monitor with a
touchscreen for user input and an alarm system with audio and video
components. In addition, a printer is used to create a hard copy
record of sedation information. When the monitored patient
physiologic measurements are within desired parameters, an alarm
box area of the monitor displays green. When the respiratory rate
or oxygen saturation (SpO.sub.2) is outside a desired state by a
first amount, their respective status bar indicates a first alarm
condition by displaying it in the color yellow. When these same
physiologic parameters are outside the desired state by a larger
second amount, the respective status bar indicates a second alarm
condition by displaying red. In addition to the visual indicators,
SDS 100 incorporates distinct audible tones for different alarm
levels (i.e., yellow or red).
[0346] PRU 200 is powered by universal power supply (UPS) 214,
which converts available a/c voltage to constant DC voltage. This
voltage is provided to all modules within SDS 100. UPS 214 also
includes a battery powered back-up system that allows the user
several minutes of system use time in the event of a power
failure.
[0347] PRU 200 includes PRU host controller 204 which has both
hardware and software modules. The hardware contains interface
components for communicating with all of the patient monitors. This
communication includes receiving patient data, monitoring operating
status, and sending routine commands to the modules. The software
also processes data received from the patient monitors for display
on the video display monitor. The software contains drivers for the
display, touchscreen, speakers, internal memory, printer, ARM
functions, Ethernet port, external video display, internal sensors,
and infusion pump 220.
[0348] Operating software controls the interaction and function of
SDS 100. Through the monitoring shell, the software makes pertinent
decisions based on information it receives from user input, various
internal sensors, and patient monitors. If the patient status
reaches a level outside of desired limits for conditions associated
with deeper than desired sedation (e.g., low respiratory rate or
low oxygen saturation), the software takes appropriate action
alerting the user and decreasing or stopping the administration of
drug(s). The software also executes delivery of drug(s) based on
the dose rate prescribed by the user. The infusion model is based
on pharmacologic principles and uses patient weight along with
desired dosage to calculate the infusion rate of drug(s).
[0349] As a user convenience, SDS 100 contains software to
automatically prime the patient infusion line 224 when a valid drug
delivery cassette and drug vial is loaded into infusion pump 220.
As a monitoring feature, with cassette 251 installed into infusion
pump 220, a sensor detects the presence of the t-site connector
installed on drug delivery cassette 251. The SDS primes the
infusion line 224 when the t-site is detected as being attached to
the drug delivery cassette.
[0350] The following paragraphs present particular examples of
several SDS 100 functional subsystems comprising components of one
or more of the previously-described aspects, and the one
previously-described combination of particular examples of aspects,
of the invention.
[0351] The oxygen delivery functional subsystem accepts
supplemental oxygen from a standard user-provided external source
and dispenses it to the patient in a controlled flow pattern that
is influenced by the patient's breathing pattern. When the patient
is breathing primarily from a nasal aspect, the oxygen is at a
higher flow rate during inhale and at a lower flow rate during
exhale. When the patient is breathing primarily orally, the oxygen
is turned on continuously. The flow rate is adjustable by the user
input to the PRU GUI 210. The oxygen is delivered to the patient by
means of the oral/nasal cannula 145, which includes a specialized
mask-like portion that is affixed to the oral/nasal zone of the
patient's face.
[0352] The oxygen flow is controlled within the PRU console 444 in
accordance with algorithms that are influenced by the patient's
nasal pressure. The metered oxygen flow produced by PRU console'
444 is presented to and fed through the umbilical cable 160 to the
BMU 300. The BMU 300 presents the oxygen to a single-use disposable
called the oral/nasal cannula 145 that is attached to the BMU 300.
The oral/nasal cannula 145 conveys the oxygen to the patient, via
its oxygen tube 353, and dispenses the oxygen to the patient's
nasal and oral zones via two nasal oxygen prongs 422 and one oral
prong 369.
[0353] The oxygen delivery functional subsystem has several
ancillary oxygen related functions, which are primarily resident
within the PRU console 444. These functions include a means to
verify that the supplemental oxygen supply is not hypoxic and is
not at an oxygen content lower than ambient air. In the event of
detection of hypoxic gas, the PRU console 444 will shut off gas
delivery to the patient and alert the user. Another ancillary
oxygen function is protection against inadvertently high pressure
supplemental oxygen acquired from the user's supplemental oxygen
source, which is mitigated via pressure release blow-off of the
excessive pressure. Another ancillary oxygen function is protection
against inadvertently high oxygen pressure in the relatively low
pressure oxygen flow path, which is mitigated via pressure release
blow-off of the excessive pressure. Another ancillary oxygen
function is the detection of a disconnected umbilical pneumatic
cable connector end A 161 or umbilical pneumatic cable connector
end B 162 at either the PRU console 444 or at the BMU 300 or the
disconnection of the oral/nasal cannula 145 from the BMU 300. When
the oral/nasal cannula 145 is disconnected from the BMU 300, the
oxygen is not delivered to the intended patient site. This
disconnection is detected by PRU console 444's observation of the
unexpected pressure level measured in the oxygen delivery path.
When detachment is discerned, the oxygen delivery is automatically
ceased by the PRU console 444 until the detachment is resolved by
the user. Another ancillary oxygen function is the hand-operated
oxygen gas valve called the oxygen diverter 492 at the rear of the
PRU console 444. The oxygen diverter 492 permits the user to
conveniently manually divert the incoming supplemental oxygen away
from the PRU Console 444 interior and instead present that oxygen
supply to an SDS-system-bypass oxygen source fitting referred to as
the barbed oxygen outlet 494. The barbed oxygen outlet 494 permits
the user to access oxygen via the SDS 100 for use with alternate
oxygen care equipment, such as would be utilized to bypass the SDS
system.
[0354] The oxygen manifold 206, located in the PRU console 444, is
a metallic structure containing internal hollow pathways that
provides an efficient means for routing the supplemental oxygen to
or through oxygen-related measurement and control devices that are
mounted to the oxygen manifold 206 or are not mounted to the oxygen
manifold 206 but are plumbed to the oxygen manifold 206. The
supplemental oxygen is attached by the user to a coupling on the
oxygen manifold 206 referred to as the oxygen input coupler 484,
which is located at the rear of the PRU console 444. This incoming
oxygen has its pressure measured by a high side pressure sensor
487, located on the oxygen manifold 206 that monitors the high side
pressure and presents that data to the PRU host controller 204.
This incoming oxygen is also presented to a high side pressure
relief valve 485, located on the oxygen manifold 206, which will
exhaust excessive pressure to the ambient atmosphere. This incoming
oxygen is also presented to an oxygen sample solenoid 481 that is
normally closed except during sampling. Whenever the PRU console
444 checks the incoming oxygen for possible hypoxic content, the
oxygen sample solenoid 481 is momentarily opened. This presents a
stream of incoming oxygen that is blown down an ancillary gas path
past the oxygen sensor 482 and subsequently exhausted out of the
oxygen manifold 206 to the ambient atmosphere. The PRU host
controller 204 compares this sample to the oxygen content of the
ambient air, having measured ambient air oxygen concentration prior
to or after incoming oxygen sampling. If the incoming oxygen sample
has a higher content of oxygen, then the supplemental oxygen
connected to the PRU console 444 is deemed non-hypoxic and is
permitted to be utilized by the SDS 100.
[0355] The incoming oxygen primary gas path continues into the
oxygen diverter 492. The oxygen diverter 492 normally allows the
oxygen to pass through along the primary gas path. However, if the
oxygen diverter knob 493 is in the SDS-system-bypass position, the
oxygen is instead directed away from the primary gas path and
rather is directed into an oxygen external output orifice 478 that
serves as a flow restrictor. Then the oxygen goes to an external
nozzle referred to as the barbed oxygen outlet 494. The primary
oxygen path proceeds to the fixed restrictor 489, which is a single
size orifice that provides a controlled restriction of oxygen flow
and produces a resulting differential pressure across the orifice
that is proportional to flow rate through the fixed restrictor 489.
The differential pressure, as seen on each side of the fixed
restrictor 489, portrays the oxygen flow rate in the primary gas
path; whereby the flow is implicitly measured via a pair of tubes
that convey these two pressures to a differential pressure sensor
479 that is located on the system input/output (I/O) board. The
differential pressure transducer 479 provides the oxygen pressure
data to the PRU host controller 204. The PRU host controller 204
determines the implied oxygen flow rate through the fixed
restrictor by means of mathematical formulae and tabulated
correlation data.
[0356] The oxygen proceeds past the fixed restrictor 489 and
proceeds into a voltage sensitive orifice (VSO) solenoid, referred
to as VSO Solenoid 480, which has an orifice size that is
proportional to the voltage applied to its actuator coil. The VSO
variable gas flow restriction provides for the PRU console 444
control of the oxygen gas flow rate, including the complete
shut-off of oxygen flow when appropriate. The VSO solenoid 480 is
operated by the PRU host controller 204 in accordance with the
oxygen control algorithm, utilizing a hardware/software feedback
loop that includes the differential pressure sensor 479. The output
of the VSO solenoid 480 is presented to a low side pressure sensor
488 that monitors the low side pressure and presents that data to
the PRU host controller 204.
[0357] The primary gas path continues past a low side pressure
relief valve 486 which will exhaust excessive pressure to the
ambient atmosphere. The oxygen exits the oxygen manifold 206 at a
fitting, which has flexible tubing, connected to it. This flexible
tubing conveys the flow-controlled oxygen over to the PRU umbilical
cable pneumatic receptacle 462 located at the front of the PRU
console 444. One of the channels of the PRU umbilical pneumatic
receptacle 462 is dedicated for oxygen delivery. The umbilical
cable 160 is attached by the user to the PRU umbilical pneumatic
receptacle 462. The controlled flow oxygen is transported along the
umbilical cable 160 via a dedicated oxygen tubing line within the
umbilical cable 160 where it is delivered at the other end of the
umbilical cable 160 into the BMU 300.
[0358] The capnometry functional subsystem (CFS) provides the means
to measure and display the patient's exhaled CO2 levels, end tidal
CO2 (EtCO2), and respiration rate (RR). This CO2 related data is
presented on the PRU screen in the form of a CO2 graph, EtCO2
value, and RR value that is updated on a breath-to-breath basis.
The CFS collects patient exhale samples of the nasal and oral site,
monitors patient nasal exhale velocity, analyzes the exhale samples
for CO2 content, selects the most robust CO2 data, whether it be
nasal or oral, in accordance with algorithms that then display the
most robust data and derivatives of that data on the PRU
Monitor.
[0359] Ancillary functions of the CFS include detection of occluded
or partially occluded exhale sample air line, filtration to guard
against intrusion of air-borne particulate that could effect the
measurement sensor, extended capacity trapping of water condensate
precipitating from the sampled air, and reduction of sampled air
humidity to avoid precipitation of fluid in the measurement
sensor.
[0360] The cannula has two nasal exhale sample ports, left and
right nostril that are inserted into the patient's nostrils. Each
sample port has its own dedicated sample line tube that extends to
the cannula SPU (single-patient-use) connector. The cannula SPU
connector body joins the sample paths of these two tubes into a
singular sample path where mixing of the two samples occurs. At
this point, a singular nasal-dedicated water trap is employed to
separate out precipitate that is present. The combined nasal sample
is presented at the nasal exhale sample output of the SPU cannula
connector. There are also two additional tubes emanating from the
left and right nasal sample ports, which convey the pressure of
these two ports over to the cannula SPU connector. These two
pressure signals are conveyed discretely to the output of the
cannula SPU connector without combining with each other.
[0361] The cannula has one oral exhale sample port that is
positioned in front of the mouth. This sample port has its own
dedicated sample line tube that extends to the cannula SPU
connector. At this point, an oral-dedicated water trap is employed
to separate out precipitate that is present. The oral sample is
presented at the oral exhale sample output of the cannula SPU
connector.
[0362] The BMU cannula connector accepts the cannula SPU connector
and associated nasal/oral exhale samples and nasal pressure signal.
The nasal exhale sample is conveyed, via tubing, through the BMU
and is presented at the BMU umbilical pneumatic receptacle as a
single pneumatic line in that connector. The oral exhale sample is
conveyed through the BMU and is presented at the BMU umbilical
pneumatic receptacle as a single pneumatic line in that connector.
The nasal pressure sample is terminated within the BMU at the nasal
pressure sensor. The nasal pressure sensor signal is measured by
the BMU expansion board, which conveys the nasal pressure signal
data to the PRU console 444 via the BMU umbilical electrical
connector and associated umbilical cable.
[0363] The oral and nasal exhale samples are transported through
oral and nasal transport tubing lines in the umbilical cable. Those
samples are delivered to the PRU umbilical pneumatic receptacle,
which conveys these exhale samples to the inside of the PRU console
444.
[0364] The nasal exhale sample is then directed into a hydrophobic
filter that prevents airborne particulate and water droplets from
proceeding further into the system. The filtered exhale sample is
fed, via tubing, to the nasal capnometer module. The nasal
capnometer module performs CO2 measurements upon the exhale sample
as it passes through the capnometer CO2 sensor. The nasal
capnometer is an OEM (original equipment manufacture) device, made
by Cardio Pulmonary Technology Inc, part number CO2WFA. It contains
an infrared (IR) sensor, control electronics, pressure sensor, and
pneumatic reservoir. The exhale sample exits the nasal capnometer
module and travels via tubing to the nasal capnometer pump 141
which is located in the E-PAC.TM. chassis within the PRU console
444. The nasal capnometer pump 141 provides the vacuum that is
propelling the sample from the cannula into the PRU console 444.
The nasal capnometer pump 141 is controlled by the nasal capnometer
module control electronics, which controls and regulates the air
flow to a target flow rate. The nasal exhale sample passes through
the nasal capnometer pump 141 and then passes through tubing to an
exit port located within the PRU console 444 where that gas is
diluted with the PRU console 444 enclosure air that is being
circulated by the PRU console fan.
[0365] The oral exhale sample is directed into a filter that
prevents airborne particulates from proceeding further into the
system. The filtered exhale sample is fed, via tubing, to the oral
capnometer module. The oral capnometer module performs CO2
measurements upon the exhale sample as it passes through the
capnometer CO2 sensor. The oral capnometer is an OEM device, made
by Cardio Pulmonary Technology Inc, part number CO2WFA. It contains
an infrared (1R) sensor, control electronics, pressure sensor, and
pneumatic reservoir. The exhale sample exits the oral capnometer
module and travels via tubing to the oral capnometer pump 142 which
is located in the E-PACTM chassis within the PRU console 444. The
oral capnometer pump 142 provides the vacuum that is propelling the
sample from the cannula into the PRU console 444. The oral
capnometer pump 142 is controlled by the oral capnometer module
control electronics, which controls and regulates the air flow to a
target flow rate. The oral exhale sample passes through the oral
capnometer pump 142 and then passes through tubing to an exit port
located within the PRU console 444 where that gas is diluted with
the PRU console 444 enclosure air that is being circulated by the
PRU console fan.
[0366] The nasal pressure subsystem monitors the patient nasal
exhale pressure and the corresponding pressure data is employed in
a nasal pressure algorithm to determine when the patient is deemed
to be in a nasal breathing mode or an oral breathing mode.
[0367] The cannula body has two nasal pressure measurement
channels, one for each nostril. The pressure encountered by each
nasal channel by the cannula body is conveyed by two independent
pneumatic lines to the cannula connector that is attached by the
user to the respective BMU receptacle. These two pneumatic lines
are combined together as a singular pneumatic pressure signal at
the cannula connector. The singular nasal pressure signal is
conveyed into the BMU. This nasal pressure is conveyed by a single
tube to a BMU pressure sensor located inside the BMU. The BMU
pressure sensor measures the relative nasal pressures presented to
the cannula body and converts this analogous pressure to an
electrical signal that is processed by the BMU expansion board and
communicated via the umbilical cable to the host controller in the
PRU.
[0368] The PRU host controller utilizes algorithms to analyze the
pressure signal and thereby produces synchronization signals that
provide timing cues relating to specific events, namely, when the
nasal inhale has begun and when the nasal inhale has ceased and
when the nasal exhale has begun and when the nasal exhale has
ceased. Also, in the event that the patient is in an oral breathing
mode, the nasal pressure signal is sufficiently weak to be
recognized by these algorithms and produces a cue for the PRU host
controller that indicates the oral breathing mode.
[0369] These nasal inhale/exhale timing cues and oral inhale/exhale
timing cues are utilized by the respiratory functional subsystem to
coordinate timed delivery of variable flow rate oxygen and also
coordinate selection of oral or nasal capnometer data for use in
displayed CO2 waveform, EtCO2 calculation and display, and
respiration rate calculation and display.
[0370] The respiratory functional subsystem includes the
supplemental oxygen subsystem, the capnometry functional subsystem,
and the nasal pressure subsystem. These subsystems operate in a
coordinated fashion by means of system level algorithms and control
programs.
[0371] When the patient is in an oral breathing mode, the oxygen
delivery subsystem is directed to set the oxygen flow to a present
continuous flow rate. When the patient is in a nasal breathing
mode, the oxygen delivery subsystem is directed to gate the oxygen
flow between a fast and a slow flow rate in synchrony with the
patient inhale/exhale timing. This synchrony is performed by means
of the nasal pressure subsystem function to determine when the
nasal inhale has begun and when the nasal inhale has ceased and
when the nasal exhale has begun and when the nasal exhale has
ceased. These inhale/exhale begin/cease detection means serve as
cues for the control of step changes in oxygen flow rates. Thus,
the oxygen delivery is a varying flow rate in synchrony with the
patient's respiratory cycle.
[0372] The drug delivery functional subsystem provides a means for
controlled delivery of drug(s) from the drug vial 250 installed in
the PRU console. The drug pumping means includes an IV pump module
that operates in conjunction with an installed cassette. The drug
pumping rate is controlled by commands issued to the IV pump module
from the PRU host controller.
[0373] Ancillary functions of the drug delivery functional
subsystem include pump door lock/unlock, detection of the T-site
commercial luer position within the designated home location of the
cassette, detection of the presence of the drug vial seated within
the cassette, air-in-line detection for detecting air in the IV
line, detection of occlusion of the IV line, and an
undesired-pumping detection monitor.
[0374] The pump is enabled when the T-site commercial luer is
seated within the cassette. The pump door can be opened when the
T-site commercial luer is seated within the cassette.
[0375] The umbilical cable power control subsystem (fast switch and
state circuit) includes the umbilical cable in conjunction with PRU
console fast switch, PRU state circuit, BMU fast switch, BMU state
circuit, and the PRU host controller.
[0376] The umbilical cable conveys power from the PRU to the BMU.
The power provided to the BMU is for powering the BMU related
circuitry including the recharging of the BMU battery. The
umbilical cable utilizes a power management control subsystem that
permits the "hot swap" of the umbilical cable while the equipment
is energized. The umbilical cable power management disconnects
power when the umbilical cable connector has become slightly
disengaged from full connection. This helps prevent any spark
during detachment of the umbilical cable and also helps prevent the
umbilical cable connector contacts from being overly stressed due
to insufficient connector engagement. These power-ceasing
mitigations are implemented regardless of which end of the
umbilical cable is detached. These functions are provided by means
of a jumper located at each end of the umbilical cable, which
straps between the shortest pin, called the fast pin, in the
connector, and the power return pin of the connector. The strap
located at the first end of the umbilical cable is detected by the
PRU console fast switch. The strap located at the second end of the
umbilical cable is detected by the BMU fast switch.
[0377] Upon disconnection of the umbilical, the fast pin is the
first pin to break contact with the respective receptacle. This
triggers the respective fast switch to interrupt power flow through
the umbilical cable power pins.
[0378] Another function of one example of the umbilical cable power
control subsystem is to help shut off power to umbilical cable
connector pins at either end of the umbilical cable when the
umbilical cable is disconnected from the PRU or the BMU. This
function is accomplished by means of the PRU console fast switch,
the PRU state circuit, the BMU state circuit, and the PRU host
controller. In this example, when the umbilical is disconnected
from the BMU under nominal conditions, the BMU state circuit in
conjunction with the PRU state circuit detects the disconnection
and the PRU state circuit turns off the PRU fast switch, which
disconnects power and communications to the umbilical resulting in
no power at the pins of the Umbilical Cable. In this example, in
the event of a non-nominal condition of some aspects of the state
circuit, the absence of communications via the umbilical cable is
detected and tagged by the PRU host controller as a possible
disconnection of the umbilical cable, which evokes a turn-off
signal to the fast switch. The fast switch disconnects both the
power and communications lines signals that are applied to the
umbilical cable.
[0379] The following paragraphs present a description of one
particular exemplary use of SDS 100 without limiting the scope of
the invention. As shown in FIGS. 77-80, components of SDS 100 are
employed throughout a surgical procedure, including pre-procedure
set-up and post-procedure recovery. The patient arrives in the
pre-procedure room, step 1200. A nurse or technician mounts BMU 300
to either the bedrail or IV pole, step 1201. BMU 300 is equipped
with an IV pole clamp or a quick connect to quickly and easily
mount the unit on either the bedrail or IV pole. Once BMU 300 is in
place, the nurse or clinician may connect NIBP cuff 120 and pulse
oximeter probe 110 to the patient, step 1202. These connections are
made between the patient and BMU 300. BMU 300 will automatically
begin monitoring parameters such as, for example, diastolic and
systolic blood pressure, mean arterial pressure, pulse rate,
oxygenation plethysmogram, and oximetry value, steps 1203 and 1204.
The readings taken by BMU 300 will be displayed for the nurse or
technician on BMU GUI 212. While patient parameters are being
monitored, the nurse or technician is free to perform other tasks.
As is customary with current practice, the nurse or technician may
need to complete a pre-procedure assessment, step 1206. The
pre-procedure assessment may include recording patient vital signs,
determining any known allergies, and determining patient's previous
medical history. Once the nurse or technician has completed the
pre-procedure assessment, step 1206, the nurse or technician may
start the peripheral IV by placing a catheter in the patient's arm,
step 1207. The IV catheter is connected to the primary IV drip
device such as, for example, a 500 mL bag of saline fluid. Upon
completion of the above activities, the nurse or technician begins
to attach ECG pads 130, ARM handset 342, ARM earpiece 362 and oral
nasal cannula 351 to the patient, step 1208.
[0380] Once the patient is connected to the above-mentioned items,
the nurse or technician may explain ARM system 340 to the patient.
This explanation may involve the nurse or technician instructing
the patient to respond to auditory stimulation from earpiece 362
and/or tactile stimulation from ARM handset 342 by squeezing ARM
handset 342. If the patient fails to respond to either auditory or
tactile stimulation, the intensity of the stimulation will increase
until the patient responds successfully. At this point, the nurse
may initiate an automated ARM training, step 1209. Automated ARM
training is a program run by BMU 300 that teaches the patient how
to detect an ARM stimulus and how to respond to that stimulus and
sets a baseline patient response to the stimulus as disclosed in
the previously referenced U.S. patent application Ser. No.
10/674,160. The nurse or technician is free to perform other
patient related tasks while the patient is participating in the
automated ARM training. BMU 300 will display the automated ARM
training status so the nurse or technician can quickly determine if
the patient is participating in the automated training. The patient
must successfully complete the automated ARM training to proceed,
step 1210; if the patient fails to complete the training a nurse or
other clinician must intervene and determine if the patient may
continue, step 1210-A. If the clinician decides the user may
proceed, then the patient will proceed to step 1211; if the
clinician decides the patient is unable to continue, then the
procedure will be canceled, step 1213. The user may customize the
automated ARM training to automatically repeat at specified
intervals (i.e. 10 minutes) if the patient is required to wait to
enter the procedure room. This will help to instill the newly
learned response.
[0381] In addition to successfully completing automated ARM
training, the patients parameters must be in an acceptable range,
step 1205. The clinician may decide upon what an acceptable range
is by inputting this information into BMU 300 by means of BMU GUI
212. If any one of the parameters being monitored falls outside a
given range, the patient will not be permitted to undergo a
procedure until a nurse or other clinician examines the patient to
determine whether or not the patient may continue, step 1205-A. If
the clinician decides the patient is able to continue, the patient
will proceed to step 1211, if the clinician decides the patient is
unable to continue, then the procedure will be cancelled, step
1213. Just prior to leaving the pre-procedure room for the
procedure room, the nurse administers a predetermined low dose of
an analgesic drug, step 1211 such as, for example, a 1.5 mcg/kg of
Fentanyl. After the injection of the analgesic drug, the patient is
ready to be moved to the procedure room, step 1212.
[0382] The patient and BMU 300 relocate to the procedure room, step
1220 and are received by the physician (non-anesthesiologist) and
procedure nurse. BMU 300 may be connected to PRU 200 via umbilical
cable 160 upon the patient entering the procedure room, step 1221.
Upon connection, the NIBP, pulse and oximetry history from the
patient will automatically up-load to PRU 200 displaying patient
history for the last period of monitoring. In addition to NIBP and
pulse oximeter history, a record verifying the patient has
completed ARM training will also be uploaded. Upon connection of
BMU 300 to PRU 200, the BMU GUI 212 changes from a monitoring
screen to a remote entry screen for PRU 200. Display information
from BMU 300 is automatically transferred to PRU 200.
[0383] At this point, the procedure nurse may secure oral nasal
cannula 145 to the patient's face, step 1222, if not already done
so in the pre-procedure room. PRU 200 may begin monitoring patient
parameters such as, for example, ARM, ECG, and capnography now that
all connections between the patient and PRU 200 (via BMU 300) are
complete, step 1223. PRU 200 will continue monitoring patient
parameters such as, for example, NIBP, pulse, and oximetry, step
1224. Next the procedure nurse may scan the bar code label on the
packaging of a drug cassette 251 and place the drug cassette within
PRU 200 and spike a standard drug vial, step 1225 onto vial spike
261. Once the fluid vial and drug cassette 64 are loaded correctly,
the nurse may autoprime IV tubing 259. In one embodiment, the
procedure nurse would press a button located upon PRU 200 to
initiate the autopriming, step 1227, or the autopriming may be an
automatic procedure initiated by PRU 200 when all safety conditions
are met. Autopriming is the automatic purging of air from IV tubing
259. PRU 200 continuously monitors the autopriming process to
determine the overall success of the autopriming. If PRU 200 fails
to properly purge IV tubing 259, a warning notification is made to
the user so that the procedure nurse may repeat the autopriming
sequence until IV tubing 259 is successfully purged, step 1227.
[0384] Upon successful completion of the autopriming sequence, the
procedure nurse may enter the patient weight in pounds while the
physician (non-anesthesiologist) may enter the initial drug
maintenance dose rate as well as dose method; normal or rapid
infusion, step 1229. After the patient weight and dose rate have
been inputted, the physician or procedure nurse may initiate drug
infusion, step 1230. While the drug is taking effect upon the
patient, the physician may perform standard procedure related
activities such as, for example, test the scope, and apply any
topical anesthetic. Once the drug has taken the desired effect upon
the patient, the physician and procedure nurse are free to conduct
the procedure, step 1231. Upon completion of the procedure, the
clinician may disconnect the drug delivery cassette from the
catheter, step 1232 and disconnect the BMU 300 from the PRU 200,
step 1233. If the clinician so desires, PRU 200 may print a record
of the patient's physiological parameters from printer 454 at this
time, step 1234. Included on the print out of the procedure record
are patient monitoring data such as, for example, NIPB, pulse
oximetry, capnography, respiration rate, and heart rate. Other
system events included in the print out are, ARM competency, ARM
responsiveness during the procedure, oxygen delivery history, drug
dose, monitoring intervals, drug bolus amount and time, and total
drug volume delivered during the procedure. The printout includes a
section where the procedure nurse may enter notes, such as, for
example, additional narcotic delivered, topical spray used, Ramsey
Sedation Scale, procedure start and finish time, cautery unit and
settings used, cautery grounding site, dilation equipment type and
size, and Aldrete Score. After printing the patient record, the
patient may then be moved to the recovery room, step 1235.
[0385] The patient arrives in the recovery room 1240 still attached
to BMU 300 after leaving the procedure room. At this point, BMU 300
may be operating on either battery or AC power. Upon entering the
room, the attending clinician may remove the ECG pads, ECG lead
wires, ARM handset, and earpiece from the patient 1241. Depending
upon clinician preference and status of the patient, the patient
may require supplemental oxygen while in the recovery room 1242. If
the patient does require supplemental oxygen, oral nasal cannula
145 is left on the patients face and oxygen is accessed from an
external source such as, for example, a headwall or tank via
connector 152 and BMU connector 151, step 1243. If no supplemental
oxygen is required in the recovery room, the nurse or technician
may remove oral nasal cannula 145 from the patient 1244.
[0386] The nurse or technician may now organize ECG leads 334 and
ARM handset 342 and place near BMU 300 to be used on the next
patient 1245. Alternatively, ARM handset 342 may be used for
patient for time-based responsiveness to queries from ARM. The
nurse or technician may need to fill out additional information on
the patient record 1246. The nurse or technician will most likely
write notes describing the patient's condition during recovery and
record NIBP, pulse rate and oximetry values of the patient during
recovery. ECG pads 332 and oral nasal cannula 145 may be discarded
at this point into a standard waste container located in the
recovery room 1247. It is important to note that BMU 300 is still
collecting data related to NIBP, pulse rate, and pulse oximetry
1248. The nurse or technician must determine if the patient is
ready to be discharged 1249. Criteria for discharge vary among
patient care facilities, however an Alderate score of 10 is common
for discharge. Other measures of discharge criteria include
responsiveness to queries through ARM, skin color, pain assessment,
IV site intact, NIBP, pulse, respiration rate, and oximetry values
all must be close to the measurement taken in pre-procedure. If the
patient does not meet any of these criteria, it is recommended that
the patient receive additional monitoring 1248. Once a patient is
cleared for discharge, the nurse or technician disconnects NIBP
cuff 58, pulse oximeter probe, and if not done so already, oral
nasal cannula 145 and ARM handset 342 from the patient 1250. Once
all the above is completed, the patient may be discharged from the
care facility 1251.
[0387] Now referring to FIG. 81, peripheral medical display 1252
receives processed patient data from medical effector system 100'
and then displays the processed patient data on peripheral LCD
screen 1253. Information that may be displayed includes heart rate,
blood pressure, pulse oximetry, capnography, electrocardiogram, and
other medical parameters that are processed by medical effector
system 100'. In addition to patient data, the peripheral medical
display 1252 may display procedural parameters related to the
function of medical effector system 100'. The functional parameters
may include; battery charge level, duration of the current
procedure, patient name, and other descriptive patient data,
information related to IV pump module 220, the pharmaceutical drug
being supplied to the patient and other parameters. Peripheral
medical display 1252 further includes the ability to allow a
medical practitioner set predetermined parameter limits, which if
exceeded result in an alarm action by peripheral medical display
1252 which may be in addition to any alarm generated by medical
effector system 100'. The alarm action may be in the form of a
flashing light from peripheral light bar 1254, an auditory signal
from peripheral speaker 1255, or a pop-up alarm on peripheral LCD
touchscreen 1253.
[0388] Peripheral medical display 1252 may also display the output
of another medical device such as endoscopic camera 1256.
Peripheral medical display 1252 has the capability to
simultaneously display the output of endoscopic camera 1256 as well
as patient and procedural data on peripheral LCD touchscreen 1253.
This functionality allows a medical practitioner to view relevant
patient and procedural data without diverting his or her attention
from the output of the endoscopic camera.
[0389] Peripheral medical display 1252 may also contain a user
interface to allow a medical practitioner to alter display settings
on the peripheral medical display 1252. A user interface may be in
the form of PRU monitor touchscreen 443 or peripheral monitor LCD
touchscreen 1253 located on peripheral medical display 1252. From
the user interface, the medical practitioner may alter various
visualization parameters including; selecting which medical and
procedural parameters if any to overlay on the output of the
endoscopic camera. Furthermore, the medical practitioner may modify
the size and location of the parameter displays relative to one
another. Additional options available through the user interface
include, selecting the display format or medical parameters (bar
graph, gauge, histogram, pictorial, or numeric), color adjustment,
establishing a schedule to automatically change visualization
parameters, establishing a priority of displays in the event of an
alarm action, magnification of the output of the endoscopic camera,
and selection of an alternate video source, as well as other
visualization options. The patient and procedural parameters may be
located apart from the output of endoscopic camera 1256 or may be
overlaid on the output of endoscopic camera 1256. This is
accomplished by a video mixing apparatus located in either
peripheral medical display 1252 or medical effector system 100'.
Similarly peripheral medical display 1252 may utilize a
picture-in-picture display incorporating the output from endoscopic
camera 1256 or other video source.
[0390] While aspects, embodiments and examples, etc. thereof, it is
not the intention of the applicants to restrict or limit the spirit
and scope of the appended claims to such detail. Numerous other
variations, changes, and substitutions will occur to those skilled
in the art without departing from the scope of the invention. For
instance, the medical effector system and components thereof of the
invention have application in robotic assisted surgery taking into
account the obvious modifications of such systems and components to
be compatible with such a robotic system. It will be understood
that the foregoing description is provided by way of example, and
that other modifications may occur to those skilled in the art
without departing from the scope and spirit of the appended
claims.
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