US20060042631A1 - Apparatus to deliver oxygen to a patient - Google Patents

Abstract

Disclosed is an oxygen delivery device for regulating the flow of oxygen from an oxygen source to a respiratory cannula located on the face of a patient. A host controller coupled to the oxygen delivery device accepts an input from a medical monitor relating to the blood oxygen saturation percentage of the patient. The host controller then regulates the rate of oxygen supplied to the patient based in part upon the blood oxygen saturation percentage of the patient. A high rate of oxygen is supplied to the patient when the controller detects a blood oxygen saturation level below a predetermined percentage and a low rate of oxygen is supplied when the controller detects a blood oxygen saturation level above a predetermined percentage in an order to minimize wasted oxygen.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• 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
• The present application relates to the following commonly assigned patent applications “Bite Block Assembly” [END5298USNP1], 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. ______; “Medical Effector System” [END5298USNP], 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 CO₂Gas 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
• 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
• 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.
• 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.
• 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
• 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.
• 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.
• 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
• 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;
• FIGS. 2 and 3 are cross-sectional views of tubing, taken along lines2-2 and3-3 ofFIG. 1, showing separate lumens that conduct gases to/from the oral/nasal cannula;
• FIG. 4 is a perspective view of the oral/nasal cannula ofFIG. 1 without any connecting tubes;
• FIG. 5 is a cross-sectional view taken along lines5-5 inFIG. 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;
• FIG. 6 is a block diagram identifying elements of an embodiment of an oral/nasal cannula assembly, including the oral/nasal cannula ofFIG. 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);
• FIG. 7 is a top planar view of the oral/nasal cannula ofFIG. 4 with the cannula cap removed;
• FIGS. 8 and 9 are cross-sectional views of the oral/nasal cannula ofFIG. 7, taken along lines8-8 and9-9 ofFIG. 7, indicating paths for oxygen and CO₂gases;
• FIG. 10 is a distal end view of the oral/nasal cannula BMU connector ofFIG. 1 without any connecting tubes;
• FIG. 11 is a cross-sectional view of the oral/nasal cannula BMU connector ofFIG. 10, taken along lines11-11 inFIG. 10, showing the recess for the nasal moisture chamber;
• FIG. 12 is an enlarged view of a portion of the oral/nasal cannula BMU connector ofFIG. 11 showing details of CO₂gas lines;
• FIG. 13 is an exploded view of the oral/nasal cannula connector ofFIG. 10 showing the outlet cover, gasket and back plate;
• FIG. 14 is a schematic, side-elevational, cross-sectional view of the nasal moisture trap chamber ofFIG. 13;
• FIG. 15 is proximal connecting-end view of the back plate of the oral/nasal cannula connector ofFIG. 13 identifying individual ports;
• FIG. 16 is a proximal end view of the outlet cover of the oral/nasal cannula ofFIG. 13;
• FIGS. 17 and 18 are cross-sectional views of the outlet cover ofFIG. 16, taken along lines17-17 and18-18 ofFIG. 16, indicating paths for gases and moisture chamber details;
• 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;
• FIG. 20 is a cross-sectional view of the bite block ofFIG. 19 taken along the lines20-20 ofFIG. 19 with the addition of a medical instrument inserted in the through passageway of the bite block;
• FIG. 21 is a view, as inFIG. 20 but of a second embodiment of a bite block;
• FIG. 22 is a view, as inFIG. 20 but of a third embodiment of a bite block;
• 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;
• FIG. 24 is a top perspective view of an embodiment of a drug-delivery cassette assembly of the invention;
• FIG. 25 is a bottom perspective view of the drug-delivery cassette assembly ofFIG. 24;
• FIG. 26 is an exploded view of the drug-delivery cassette assembly ofFIG. 24 showing individual components;
• 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 ofFIG. 26;
• FIG. 28 is a perspective view of the spike bed area of the drug-delivery cassette assembly ofFIG. 26;
• FIG. 29 is a top planar view of the drug-delivery-cassette main board of the drug-delivery cassette assembly ofFIG. 26;
• FIGS. 30 and 31 are cross-sectional views of the drug-delivery-cassette main board ofFIG. 29, taken along lines30-30 and31-31 inFIG. 29, showing the vial sensor beam and the T-site sensor beam;
• FIG. 32 is a perspective view of the spike of the drug-delivery cassette assembly ofFIG. 26;
• FIG. 33 is an end view of the spike ofFIG. 32;
• FIG. 34 is a cross-sectional view (which has been rotated ninety degrees counterclockwise) of the spike ofFIG. 33 taken along lines34-34 ofFIG. 33;
• FIGS. 35 and 36 are a right-side and left-side perspective views of the spike cap of the drug-delivery cassette assembly ofFIG. 26 showing details of the cap handle and latching system;
• FIG. 37 is a side elevational view of the spike cap of the drug-delivery cassette assembly ofFIG. 26;
• FIG. 38 is an end elevational view of the spike cap of the drug-delivery cassette assembly ofFIG. 26;
• FIG. 39 is a top planar view of the spike cap of the drug-delivery cassette assembly ofFIG. 26;
• FIG. 40 is a cross-sectional view of the spike cap ofFIG. 39, taken along lines40-40 inFIG. 39, showing the spike hollow;
• FIG. 41 is a perspective view of the sedation delivery system (SDS) ofFIG. 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;
• FIG. 42 is a front perspective view of the SDS cart and the PRU ofFIG. 41 including the universal power supply (UPS) of the PRU;
• FIG. 43 is a top perspective view of the PRU ofFIG. 41 with an installed drug-delivery cassette assembly and with the pump-housing door closed;
• FIG. 44 is a top perspective view of a portion of the PRU ofFIG. 43 with the pump-housing door open and with an uninstalled drug-delivery cassette assembly;
• FIG. 45 is a top perspective view of a portion of the PRU ofFIG. 43 with an installed drug-delivery cassette assembly and with the pump-housing door open;
• FIG. 46 is a top perspective view of a portion of the PRU ofFIG. 43 with an installed drug-delivery cassette assembly, with the pump-housing door closed, and with an about-to-be-installed drug vial;
• FIG. 47 is a top perspective view of a portion of the PRU ofFIG. 43 with an installed drug-delivery cassette assembly, with the pump-housing door closed, and with an installed drug vial;
• FIG. 48 is an exploded view of the PRU ofFIG. 43;
• FIG. 49 is a rear perspective view of a portion of the PRU ofFIG. 43;
• FIG. 50 is a front perspective view of the oxygen-delivery manifold seen installed in the rear of the PRU inFIG. 49;
• FIG. 51 is a rear perspective view of the oxygen-delivery manifold ofFIG. 50;
• FIG. 52 is a cross-sectional view of the oxygen-delivery manifold ofFIG. 51 taken along arrows52-52 inFIG. 51;
• FIG. 53 is an enlarged view of a portion of the oxygen-delivery manifold ofFIG. 52;
• FIG. 54 is a top perspective view of the PRU host controller of the PRU ofFIG. 43;
• FIG. 55 is an exploded view of the drug-delivery infusion pump assembly of the PRU ofFIG. 43;
• FIG. 56 is a rear perspective view of the UPS ofFIG. 42;
• FIG. 57 is an exploded view of the UPS ofFIG. 42;
• FIG. 58 is a schematic view of an alternate embodiment of a medical effector system of the invention including an energy-delivery medical effector;
• 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;
• FIG. 60 is a front perspective view of the BMU ofFIG. 41 with connecting lines attached;
• FIG. 61 is a bottom perspective view of the BMU ofFIG. 41 with connecting lines detached;
• FIG. 62 is an exploded view of the BMU ofFIG. 41;
• FIG. 63 is a block diagram identifying elements of an embodiment of a sedation delivery system (SDS);
• FIG. 64 is a block diagram identifying elements of an embodiment of a procedure room unit (PRU) for use in an SDS ofFIG. 63;
• FIG. 65 is a block diagram identifying elements of a system board for use with a PRU ofFIG. 64;
• FIG. 66 is a block diagram of a drug delivery module for use with a PRU ofFIG. 64;
• FIG. 67 is a block diagram of an oxygen delivery module for use with a PRU ofFIG. 64;
• FIG. 68 is a block diagram of a power board module for use with a PRU ofFIG. 64;
• FIG. 69 is a block diagram of a printer module for use with a PRU ofFIG. 64;
• FIG. 70 is a block diagram of an uninterruptible power supply (UPS) for use with a PRU ofFIG. 64;
• FIG. 71 is a block diagram of a UPS module for use with a UPS ofFIG. 70;
• FIG. 72 is a block diagram of a bedside monitoring unit (BMU) for use with an SDS ofFIG. 63;
• FIG. 73 is a block diagram of a BMU expansion board for use with a BMU ofFIG. 72;
• FIG. 74 is a block diagram of a display assembly for use with an SDS ofFIG. 63;
• FIG. 75 is a block diagram of single-patient-use (SPU) items for use with an SDS ofFIG. 63;
• FIG. 76 is a block diagram of multiple-patient-use (MPU) items for use with an SDS ofFIG. 63;
• FIG. 77 is diagrammatical process flow of the BMU and PRU of an SDS ofFIG. 63 during one example of a surgical procedure;
• FIG. 78 is an overview data-flow diagram depicting the pre-medical procedure aspect of an SDS ofFIG. 63;
• FIG. 79 is an overview data-flow diagram depicting the medical procedure aspect of an SDS ofFIG. 63; and
• FIG. 80 is an overview data-flow diagram depicting the post-medical procedure aspect of an SDS ofFIG. 63.
• FIG. 81 is a front perspective of the peripheral monitor used in conjunction with the PRU.
DETAILED DESCRIPTION OF THE INVENTION
• 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.
• 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.
• Various aspects and embodiments of the invention are hereinafter described, for ease of understanding, with reference to asedation delivery system100 and a sedation drug-deliveryflow control assembly220′, but it is understood that such aspects and embodiments have equal application with reference to other examples ofmedical effector systems100′ than asedation delivery system100 and/or to other examples ofmedical effectors220″ than a drug-deliveryflow control assembly220′. 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.
• 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.
• Cannula Assembly
• A first aspect of the invention is directed to, or a component of, or can be used by, acannula assembly145, an embodiment of which is shown inFIGS. 1-18. A first expression of the embodiment ofFIGS. 1-18 is for acannula assembly145 including an oral-nasal cannula351 and aslidable tube371′. The oral-nasal cannula351 is disposable on the face of apatient10 and includes a respiratory-gas-samplingnasal prong364 or365 and a respiratory-gas-samplingoral prong369′. Theslidable tube371′ is slidably connected to one of the respiratory-gas-sampling nasal andoral prongs364,365 or369′ to accommodate different distances between the nose and mouth ofdifferent patients10. In one example, theslidable tube371′ is slidably connected to the respiratory-gas-samplingoral prong369′, wherein theslidable tube371′ has a substantially right-angle bend and a distal end14, and wherein, when the oral-nasal cannula351 is disposed on the face of thepatient10, the distal end14 of theslidable tube371′ extends distally toward or into the mouth of thepatient10. Other examples are left to the artisan.
• A second expression of the embodiment ofFIGS. 1-18 is for acannula assembly145 including acannula351′ (such as, but not limited to, an oral-nasal cannula351) and a user-detachableoral prong extension370′ or370″. Thecannula351′ is disposable on the face of apatient10 and includes a respiratory-gas-sampling or respiratory-gas-deliveryoral prong369′/371′ or369″/371″ having an opening. The user-detachableoral prong extension370′ or370″ comes removably attached to theoral prong369′/371′ or369″/371″ and is user-connectable to the opening of theoral prong369′/371′ or369″/371″. In one example of the second expression of the embodiment ofFIGS. 1-18, theoral prong369′ or369″ lacks theslidable prong371′ or371″, and in another example it does not. In one implementation of the second expression, theoral prong extension370′ or370″ 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-detachableoral prong extension370′ or370″ is manually detached by the user without the use of any tool. In one construction, theoral prong extension370′ or370″ comes removably attached to theoral prong369′/371′ or369″/371″ by a manually-breakable tether12. Alternate constructions include removable attachment by use of score lines or perforations. Other examples, implementations, and constructions are left to the artisan.
• A third expression of the embodiment ofFIGS. 1-18 is for acannula assembly145 comprising acannula351′ which is disposable on the face of apatient10 and which includes a respiratory-gas-samplingoral prong369′/371′ having a distal end14 and a respiratory-gas-deliveryoral prong369″/371″ having a distal end16 wherein, when thecannula351′ is disposed on the face of thepatient10, the distal end14 of the respiratory-gas-samplingoral prong369′/371′ extends distally further toward or into the mouth of the patient10 than the distal end16 of the respiratory-gas-deliveryoral prong369″/371″. In one example of the third expression of the embodiment ofFIGS. 1-18, the respiratory-gas-samplingoral prong369′/371′ is a carbon-dioxide respiratory-gas-sampling oral prong, and the respiratory-gas-deliveryoral prong369″/371″ is used to deliver air with an enriched oxygen content (sometimes just referred to as “oxygen”) to thepatient10. In this example, such staggering of the distal ends14 and16 of the twoprongs369′/371′ and369″/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.
• A fourth expression of the embodiment ofFIGS. 1-18 is for acannula assembly145 comprising acannula351′ which is disposable on the face of apatient10 and which includes left and rightcannula support wings367′ and367″ each having a wing tip portion with anadhesive pad366 removably adhesively attachable to a side of the face of thepatient10. In one example, no other attachment is used to secure thecannula351′ to the face of thepatient10. In this example, theadhesive pad366 provides for a more convenient cannula attachment for the patient than a conventional headband, etc. Other examples are left to the artisan.
• A fifth expression of the embodiment ofFIGS. 1-18 is for acannula assembly145 comprising acannula351′ which is disposable on the face of apatient10, which includes acannula body18 having a respiratory-gas-samplingnasal prong364 or365, and which includes acannula cap368 having a respiratory-gas-delivery nasal prong422 with a tube-receivinghole26. Thecannula cap368 is attached to thecannula body18 with the respiratory-gas-samplingnasal prong364 or365 passing through and extending beyond the tube-receivinghole26. The tube-receivinghole26 is disposed to bend the respiratory-gas-samplingnasal prong364 or365 toward the nose of the patient10 when thecannula351′ is disposed on the face of thepatient10. 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 ofFIGS. 1-18, thenasal prong364 or365 is substantially straight before thecannula cap368 is attached to thecannula body18.
• A sixth expression of the embodiment ofFIGS. 1-18 is for acannula assembly145 comprising acannula351′ which is disposable on the face of apatient10 and which includes a respiratory-gas-samplingnasal prong364 or365 having adistal end20 and a respiratory-gas-delivery nasal prong422′ or422″ having adistal end22, wherein, when thecannula351′ is disposed on the face of thepatient10, thedistal end20 of the respiratory-gas-samplingnasal prong364 or365 extends distally further toward or into one of the nostrils of the patient10 than thedistal end22 of the respiratory-gas-delivery nasal prong422′ or422″. Such staggering of the distal ends20 and22 of the twoprongs364 or365 and422′ or422″ 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 ofFIGS. 1-18, the respiratory-gas-samplingnasal prong364 or365 is circumferentially surrounded by the respiratory-gas-delivery nasal prong422′ or422″. Other examples are left to the artisan.
• A seventh expression of the embodiment ofFIGS. 1-18 is for acannula assembly145 including an oral-nasal cannula351 and aconnector363. The oral-nasal cannula351 is disposable on the face of apatient10 and includes a left-nostril respiratory-gas-sampling tube354, a right-nostril respiratory-gas-sampling tube352, and an oral respiratory-gas-sampling tube355. Theconnector363 includes acover394 and aback plate423 attached to thecover394. Thecover394 includes an interior nasalmoisture trap chamber412 and an interior oralmoisture trap chamber411 isolated from the interior nasalmoisture trap chamber412. Theback plate423 includes anasal capnometry port402 and anoral capnometry port400. The left and right nostril respiratory-gas-sampling tubes354 and352 are connected to thecover394 and are in fluid communication with the interior nasalmoisture trap chamber412. The oral respiratory-gas-sampling tube355 is connected to thecover394 and is in fluid communication with the interior oralmoisture trap chamber411. Thenasal capnometry port402 is in fluid communication with the interior nasalmoisture trap chamber412. Theoral capnometry port400 is in fluid communication with the interior oralmoisture trap chamber411.
• In one example of the seventh expression of the embodiment ofFIGS. 1-18, theconnector363 also includes ahydrophobic filter395′ disposed between the interior nasalmoisture trap chamber412 and thenasal capnometry port402 and ahydrophobic filter395,” disposed between the interior oralmoisture trap chamber411 and theoral capnometry port400. In another example, not shown, a desiccant is disposed in the nasal and oralmoisture trap chambers412 and411. Other examples are left to the artisan.
• In one variation of the seventh expression of the embodiment ofFIGS. 1-18, theconnector363 also includes an inter-flow-path-sealinggasket396 disposed between the interior nasal and oralmoisture trap chambers412 and411 and the nasal capnometry andoral capnometry ports402 and400. Thegasket396 includesannular towers24 which extend into the nasal capnometry andoral capnometry ports402 and400 and provide, at least in part, the fluid communication between the interior nasalmoisture trap chamber412 and thenasal capnometry port402 and between the oralmoisture trap chamber411 and theoral capnometry port400.
• An eighth expression of the embodiment ofFIGS. 1-18 is for acannula assembly145 including acannula351′ and aconnector363. Thecannula351′ is disposable on the face of apatient10 and includes a respiratory-gas-sampling tube354,352 or355. Theconnector363 includes acover394, aback plate423, and agasket396. Theback plate423 is attached to thecover394. Thecover394 includes an interiormoisture trap chamber412 or411. Theback plate423 includes acapnometry port402 or400. The respiratory-gas-sampling tube354,352 or355 is connected to thecover394 and is in fluid communication with the interiormoisture trap chamber412 or411, and thecapnometry port402 or400 is in fluid communication with the interiormoisture trap chamber412 or411. Thegasket396 is disposed between the interiormoisture trap chamber412 or411 and thecapnometry port402 or400. Thegasket396 includes anannular tower24 which extends into thecapnometry port402 or400 and provides, at least in part, the fluid communication between the interiormoisture trap chamber412 or411 and thecapnometry port402 or400.
• A ninth expression of the embodiment ofFIGS. 1-18 is for a cannula-assembly connector363. The cannula-assembly connector363 includes at least one cannula-assembly connector member together having anasal capnometry port402, anoral capnometry port400, anasal pressure port401, and a respiratory-gas-delivery port399. Each of theports402,400,401 and399 is fluidly-connectable to a bedside monitoring unit (BMU)300 (an embodiment of which is seen inFIGS. 6 and 60-62) of a sedation delivery system (SDS)100 (or other type ofmedical effector system100′). The terminology “fluidly-connectable” includes directly fluidly-connectable and indirectly fluidly-connectable.
• In one example of the ninth expression of the embodiment ofFIGS. 1-18, the at-least-one cannula-assembly connector member consists of a plate (e.g., back plate423). In the same or a different example, each of theports402,400,401 and399 has a center and the distance between the centers of any twoports402,400,401 and399 is shortest for the nasal capnometry andnasal pressure ports402 and401. In one extension of the ninth expression, the at-least-one cannula-assembly connector member together have anaudio port398. In one construction, theconnector363 includes aback plate423, wherein one or more or all of theports402,400,401 and399 (and, when present,398) are ports of theback plate423. In one variation, theback plate423 includes adapter pins397 for aligning and/or assisting in connecting theports402,400,401 and399 (and, when present,398) to theBMU300. In one modification, theback plate423 is configured as shown inFIGS. 13 and 15. In another construction, not shown, theconnector363 lacks a plate or a back plate. In one arrangement, theBMU300 has ports, which enter theports402,400,401 and399 (and, when present,398) of theconnector363 to provide the fluid connection. In another arrangement, theports402,400,401 and399 (and, when present,398) of theconnector363 enter ports on theBMU300 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.
• In one implementation of the ninth expression of the embodiment ofFIGS. 1-18, the bedside monitoring unit (BMU)300 is fluidly-connectable to a procedure room unit (PRU)200 (an embodiment of which is shown inFIGS. 6 and 41-57) of the sedation delivery system (SDS)100 (or other type ofmedical effector system100′). Theprocedure room unit200 includes anoral capnometer202 and a nasal capnometer140 (seeFIG. 54). When the oral andnasal capnometry ports400 and402 of theconnector363 are fluidly connected to thebedside monitoring unit300 and thebedside monitoring unit300 is fluidly connected to theprocedure room unit200, theoral capnometer202 is in fluid communication with theoral capnometry port400 and thenasal capnometer140 is in fluid communication with thenasal capnometry port402. The terminology “fluidly connected” includes directly fluidly connected and indirectly fluidly connected.
• A tenth expression of the embodiment ofFIGS. 1-18 is for a cannula water-trap subassembly28 including a cannula water-trap housing30 and ahydrophobic filter395. The cannula water-trap housing30 includes amoisture trap chamber411 or412 having a moisture-collection cavity32 and a sampled-respiratory-gas pass-throughcavity34. The sampled-respiratory-gas pass-throughcavity34 is disposed higher than, and in fluid communication with, the moisture-collection cavity32. The sampled-respiratory-gas pass-throughcavity34 has a smaller volume than the moisture-collection cavity32. The sampled-respiratory-gas pass-throughcavity34 has a sampled-respiratory-gas entrance and a sampled-respiratory-gas exit. Thehydrophobic filter395 is disposed to cover the exit of the sampled-respiratory-gas pass-throughcavity34. All sampledrespiratory gas36 entering the sampled-respiratory-gas pass-throughcavity34 must pass through thehydrophobic filter395 to exit the sampled-respiratory-gas pass-throughcavity34. Moisture in the sampledrespiratory gas36 collects in the moisture-collection cavity32.
• An eleventh expression of the embodiment ofFIGS. 1-18 is for acannula assembly145 including acannula351′, aconnector363, and anaudio earpiece362. Thecannula351′ is disposable on the face of apatient10 and includes a respiratory-gas-sampling tube354,352 or355. The respiratory-gas-sampling tube354,352 or355 is fluidly-connected to theconnector363, and theconnector363 is connectable to abedside monitoring unit300 of a sedation delivery system100 (or other type ofmedical effector system100′). Theaudio earpiece362 is disposable proximate an ear of thepatient10 and is operatively-connected to theconnector363 to give sound to the patient10 at least at the direction of thebedside monitoring unit300 when theconnector363 is connected to thebedside monitoring unit300 and theaudio earpiece362 is disposed proximate the ear of thepatient10. The term “proximate” includes, without limitation, “in” and “on”.
• In one example of the eleventh expression of the embodiment ofFIGS. 1-18, theaudio earpiece362 is disposable in the ear of thepatient10, and thecannula assembly145 includes an audio (i.e., sound)tube356 which is operatively-connected to theaudio earpiece362 and to theconnector363 and which acoustically transmits sound from a speaker in the bedside monitoring unit (BMU)300 to theaudio earpiece362 when theconnector363 is connected to theBMU300. In one employment, theBMU300 uses theaudio earpiece362 to provide thepatient10, 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 theBMU300 controls the speaker during such training. Thereafter, thepatient10, 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 system100 (or other type ofmedical effector system100′). ThePRU200 uses at least the patient response time to determine a level of consciousness of the patient10 undergoing sedation (or other type of medical procedure). In one variation, a computer program in thePRU200 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 theaudio earpiece362. In a different example, theaudio earpiece362 is a speaker on a headset and theaudio tube356 is replaced by electric wiring. Other examples are left to the artisan.
• In one application of any of the above-described expressions ofFIGS. 1-18, including examples, etc. thereof, thecannula assembly145 is directly connectable to the Bedside Monitoring Unit (BMU)300. For example, in one application of the seventh expression of the embodiment ofFIGS. 1-18, theconnector363 is directly connectable to the Bedside Monitoring Unit (BMU)300, wherein inlet ports of theBMU300 enter theannular towers24 of thegasket396 and compress theannular towers24 against the corresponding nasal capnometry andoral capnometry ports402 and400 to provide a leak-free seal. In a different application of any of the above-described expressions ofFIGS. 1-18, including examples, etc. thereof, thecannula assembly145 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 ofFIGS. 1-18, theconnector363 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 thepatient10, 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.
• Any one or more of the above-described expressions of the embodiment ofFIGS. 1-18, including examples, etc. thereof can be combined with any other one or more of the above-described expressions of the embodiment ofFIGS. 1-18, including examples, etc. thereof, as can be appreciated by those skilled in the art.
• FIGS. 19 and 20 show a first embodiment of abite block74, which, in one example, is used with thecannula assembly145 ofFIGS. 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.
• A first expression of the embodiment ofFIGS. 19 and 20 is for abite block74 including a bite-block body76 adapted for insertion into the mouth of a patient. The bite-block body76 includes a throughpassageway78 and includes anair sampling passageway80 spaced apart from the throughpassageway78. The throughpassageway78 is adapted for receiving therethrough a medical instrument82 (only an unhatched portion of which is shown inFIG. 20). Theair sampling passageway80 has aninlet84 disposed to receive exhaled air from the patient when the bite-block body76 is inserted into the mouth of the patient. Theair sampling passageway80 has anoutlet86 adapted for coupling to a respiratorygas sampling port88 of a cannula90 (only the body/cap portion of an embodiment of an oral/nasal cannula without respiratory-gas-delivery prongs is shown). In one variation, theoutlet86 of theair sampling passageway80 is adapted for indirectly coupling to the respiratorygas sampling port88 of thecannula90 through aconnector tube92.
• A second expression of the embodiment ofFIGS. 19 and 20 is for acannula assembly94 including acannula90, abite block74, and aconnector tube92. Thecannula90 is disposable on the face of a patient and includes a respiratorygas sampling port88. Thebite block74 has a bite-block body76 adapted for insertion into the mouth of a patient. The bite-block body76 includes a throughpassageway78 and includes anair sampling passageway80 spaced apart from the throughpassageway78. The throughpassageway78 is adapted for receiving therethrough amedical instrument82. Theair sampling passageway80 has aninlet84 disposed to receive exhaled air from the patient when the bite-block body76 is inserted into the mouth of the patient and has anoutlet86. Theconnector tube92 having a first end attached or attachable to the respiratorygas sampling port88 of thecannula90 and has a second end attached or attachable to the bite-block body76 at theoutlet86 of theair sampling passageway80 of the bite-block body76.
• FIG. 21 shows a second embodiment of a bite block. An expression of the embodiment ofFIG. 21 is for abite block assembly96 including a bite-block body98 and anair sampling tube102. The bite-block body98 is adapted for insertion into the mouth of a patient and includes a throughpassageway104 adapted for receiving therethrough a medical instrument106 (only a portion of which is shown). Theair sampling tube102 is attached to the bite-block body98, has aninlet108 disposed to receive exhaled air from the patient when the bite-block body98 is inserted into the mouth of the patient and has anoutlet112 attached or attachable to a respiratory gas sampling port of a cannula.
• In one variation of the embodiment ofFIG. 21, theair sampling tube102 is at least partially disposed within the throughpassageway104. In one construction, theair sampling tube102 is adhesively attached to the bite-block body98. In one employment, theoutlet112 of theair sampling tube102 is adapted for indirect attachment to the respiratory gas sampling port of the cannula through aconnector tube118.
• FIG. 22 shows a third embodiment of a bite block. An expression of the embodiment ofFIG. 22 is for abite block assembly122 including a bite-block body124 and anair sampling tube126. The bite-block body124 is adapted for insertion into the mouth of a patient. The bite-block body124 includes a throughpassageway128 adapted for receiving therethrough a medical instrument132 (only a portion of which is shown) and includes anair sampling passageway134. Theair sampling tube126 is at least partially disposed within theair sampling passageway134, has aninlet136 disposed to receive exhaled air from the patient when the bite-block body124 is inserted into the mouth of the patient, and has anoutlet138 attached or attachable to a respiratory gas sampling port of a cannula. In one variation, theoutlet138 of theair sampling tube126 is adapted for indirect attachment to the respiratory gas sampling port of the cannula through aconnector tube148.
• Examples of the embodiments ofFIGS. 19 and 20,21, and22 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.
• FIG. 23 shows a further embodiment of amedical effector system154, wherein themedical effector system154 alerts a user of a possible problem with acannula156 of themedical effector system154. An expression of the embodiment ofFIG. 23 is for amedical effector system154 including apressure sensor158, acannula156, and amemory166. Thepressure sensor158 includes aninput168 and has anoutput signal170. Thecannula156 is disposable on the face of a patient and includes a respiratory-gas-sampling tube172 operatively connectable to theinput168 of thepressure sensor158. Thememory166 contains a cannula program which when running on aprocessor174 is operatively connected to theoutput signal170 of thepressure sensor158. The cannula program alerts a user of a possible problem with thecannula156 based at least in part (and in one example based entirely) on theoutput signal170 of thepressure sensor158. It is noted that, in one example, theinput168 of thepressure sensor158 is for receiving a pneumatic signal in the form of respiratory gas from the patient.
• In one deployment of the embodiment ofFIG. 23, when thecannula156 is disposed on the face of the patient and when the respiratory-gas-sampling tube172 is operatively connected to theinput168 of thepressure sensor158, theoutput signal170 of thepressure sensor158 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 nocannula156 is disposed on the face of the patient and/or if the respiratory-gas-sampling tube172 of thecannula156 is not operatively connected to theinput168 of thepressure sensor158, then the output signal170 (which typically is an electrical signal) of thepressure sensor158 would substantially equal that of atmospheric pressure.
• In one construction of the embodiment ofFIG. 23, the respiratory-gas-sampling tube172 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 tube172 is adapted to sample respiratory gas from just one of the left nostril, right nostril, and mouth of the patient.
• In one employment of the embodiment ofFIG. 23, the possible cannula problem includes thecannula156 not being disposed (or not being disposed properly) on the face of the patient when the cannula program is running on theprocessor174. In the same or a different employment, the possible cannula problem includes thecannula156 not being operatively connected to theinput168 of thepressure sensor158 when the cannula program is running on theprocessor174.
• In one application of the embodiment ofFIG. 23, thepressure sensor158 is a component of a bedside monitoring unit (e.g., thebedside monitoring unit300 ofFIG. 6 whereinpressure sensor158 would replace nasal pressure transducer47). In the same or a different application, thememory166 and theprocessor174 are components of a host controller of a procedure room unit (such ashost controller204 of theprocedure room unit200 ofFIG. 6). In one variation, themedical effector system154 also includes an umbilical cable (such as theumbilical cable160 ofFIG. 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 acapnometer230 and234 operatively connectable to thecannula156, and the cannula program starts thecapnometer230 and234 if the cannula program does not alert the user of the possible problem with thecannula156. In another application, thepressure sensor158, thememory166, theprocessor174, and thecapnometer230 and234 are components of a single unit.
• In one arrangement of the embodiment ofFIG. 23, the respiratory-gas-sampling tube172 is an oral respiratory-gas sampling tube236, thecannula156 also includes a left-nostril respiratory-gas-sampling tube238 operatively connectable to theinput168 of thepressure sensor158, and thecannula156 additionally includes a right-nostril respiratory-gas-sampling tube240 operatively connectable to theinput168 of thepressure sensor158. In one variation, at least onevalve242,244 and246 is controllable by the cannula program to selectively operatively connect to thepressure sensor158, one at a time, the oral, left-nostril and right-nostril respiratory-gas-sampling tubes236,238 and240. Other configurations using a different number of valves, different valve design, and/or different valve connections than that shown inFIG. 23 are left to the artisan. In one modification, themedical effector system154 also includes at least onecapnometer230 and234, wherein the at-least-onevalve242,244 and246 is controllable by the cannula program to operatively connect the oral, left-nostril and right-nostril respiratory-gas-sampling tubes236,238 and240 to the at-least-onecapnometer230 and234. In one application, the at least onecapnometer230 and234 includes anasal capnometer230 which receives respiratory-gas-sampling input from both nostrils of the patient and anoral capnometer234 which receives respiratory-gas-sampling input from the mouth of the patient. In one implementation, thenasal capnometer230 and theoral capnometer234 are components of a procedure room unit (such as the previously-discussed procedure room unit200). It is noted that the connections between theprocessor174 and thecapnometers230 and234 and between theprocessor174 and the at-least-onevalve242,244 and246 have been omitted fromFIG. 23 for clarity. In other arrangements, not shown, two or three pressure sensors are employed.
• In other configurations, not shown, of a medical effector system which alerts a user of a possible problem with a cannula, eachvalve242,244 and246 (which in one example also has an off position blocking any flow from exiting the valve) ofFIG. 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.
• In one example, benefits of themedical effector system154 include automatically alerting the user of a possible problem with thecannula156 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.
• The following paragraphs present a detailed description of one particular enablement of the embodiment ofFIGS. 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 ofFIGS. 1-18. In this particular enablement, thecannula assembly145 is an oxygen (the term “oxygen” includes air with an enriched oxygen content) delivery cannula assembly, more specifically a cannula assembly145 (shown inFIG. 1) that supplies oxygen to apatient10 and collects oral and nasal exhaled breath samples for analysis. The oral/nasal cannula351 allows for measurement of end-tidal CO₂gas (the term “CO₂gas” means gas containing CO₂) from both oral and nasal cavities, as well as measurement of CO₂gas pressure from combined nasal cavities.
• Oral/nasal cannula351 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 assembly145 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.Cannula145 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 aconnector363 as an integral part of the cannula system to facilitate easy attachment and removal from Bedside Monitoring Unit (BMU)300.Cannula145 also provides for the delivery of audible commands to a patient10 requesting a response for an Automated Responsiveness Monitor (ARM).
• In one construction, oralnasal cannula351 is made of a soft pliable material that is easily deformable and will fit comfortably on a patient's10 face. This ensures patient10 comfort and minimize irritation.
• Cannula assembly145 (shown inFIG. 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.
• 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 patient10 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 thepatient10.
• As illustrated onFIGS. 1-3, oral/nasal cannula351 is designed to fit comfortably upon the upper lip of a patient10 between the nose and mouth. Oral/nasal cannula351 functions as a mask-free delivery apparatus for supplying oxygen gas to a patient10 while also providing for the monitoring ofpatient10 breathing. Oral/nasal cannula351 is connected to a set of tubing for gas sample collection, audio and oxygen delivery, and includescinch361 to help secure to thepatient10, anearpiece362 to allow audio messages to be sent to thepatient10, andBMU connector363 for secure connection to the bedside monitoring unit (BMU)300.
• Referring toFIGS. 1 and 6, thecannula assembly145 includes distal oral-nasal cannula351earpiece362 andproximal connector363. Exhalation samples from the patient10 are collected by oral-nasal cannula351 and flow through independent channels and lumens toconnector363.Connector363 is removably attached to bedside monitoring unit (BMU)300. Gases (oxygen and CO₂) are then routed via the umbilical to/from procedure room unit (PRU)200. The capnometry system includes two capnometers inPRU200. A particle and hydrophobic filter are located insidecannula connector363.Oral chamber411 andnasal chamber412 are designed to trap condensation from the patient's10 exhaled breath to avoid moisture damage to the capnometers. Anasal pressure transducer47 is located in the bedside monitoring unit (BMU)300. Thepressure transducer47 providespatient10 breathing information to procedure room unit (PRU)200 through the umbilical cable.
• As shown inFIG. 4, oral-nasal piece351 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 cap368 is generally a hollow cube and is the platform for supporting other features. Oral-nasal piece351 profile is designed to easily adapt topatient10 anatomy. Oral-nasal cannula351 includesadhesive pads366 located on the patient10 side ofcannula wings367 and are intended to adhere to and secure comfortably oral-nasal piece351 in place on the patient10's face.Cannula cap368 includesnasal prong422 andoral prong369.Cannula body18 includesnasal prongs364 and365 andoral prongs370 and371.
• FIGS. 4 and 6-9 illustrate thatcannula cap368 includes two independent gas circuits, one for collecting oral and nasal exhaled CO₂for capnometry and pressure analysis, and a second for supplying oxygen into the patient's10 nose and mouth.FIG. 8 shows a cross-section view of the oral/nasal cannula351 CO₂sampling circuit. The CO₂sampling circuit comprises a left and right nostril circuit and oral sample circuit, which are internally molded and interconnected insidecannula cap368. CO₂left circuit is comprised ofleft prong channel375 and leftchannel377, interconnected at right angles, and functioning to collect CO₂samples from the patient's10 left nostril. Left sample tube354 (FIG. 1) is inserted into and fixedly attached to leftchannel377, which divides the CO₂sampling volume into two lumens (shown onFIGS. 2-3 and6):left pressure lumen359 and leftsample lumen360. In addition, CO₂right circuit is comprised ofright prong channel374 andright channel376, interconnected at right angles, and functioning to collect CO₂samples from the patient10's right nostril. Right sample tube352 (FIG. 1) is inserted into and fixedly attached toright channel376, which divides the CO₂sampling volume into two lumens (shown onFIGS. 2-3 and6):right pressure lumen357 andright sample lumen358. The arrangement is essentially the same for an oral circuit which comprises anoral prong channel379 withinoral prongs369,371 and370; and anoral channel378 insidecannula cap368.Oral prong channel379 andoral channel378 are interconnected and collect CO₂samples from the patient10's mouth.
• As illustrated inFIGS. 7-9, a second gas circuit delivers oxygen in the proximity of the patient's10 nose and mouth.FIG. 9 shows a cross-section view of oral/nasal cannula351.Oxygen channel387 is in fluid communication withchamber384 withincannula cap368.Oxygen chamber384 has three openings: a first opening connecting tooxygen prong channel381, which delivers oxygen in the vicinity of the mouth; a second opening which communicates withright channel385 that delivers oxygen into the right nostril; and a third opening which delivers oxygen to the left nostril throughchannel386.
• As shown onFIG. 4,nasal oxygen prongs422 are mounted overprongs364 and365.Prongs422 have a tapered shape and fit co-axial aroundnasal prongs364 and365.Prongs422 include a number of holes to permit oxygen passage from withincannula cap368 to the vicinity of the patient's10 nostrils.
• The oral system is comprised oforal prongs369 which are an integral part of oral-nasal cannula351, slidingprongs371 which are slidably mounted overprongs369, and EGD (esophageo-gastro-duodenoscopy)prong extension370. The oral prong system consists of two independent channels:oxygen prong channel381 for oxygen supply; andoral prong channel379 for CO₂sample collection. Slidingprongs371 are slidably mounted overprongs369 forming an “L” shape and allow for flexibility in adapting todifferent patients10.Prongs369 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) prongs370, which are designed to mount slidably on slidingprongs371 to reach inside the patient's10 mouth.EGD prong extension370 is manufactured tethered toprongs371 but is easily detached by the user.EGD extension370 improves the delivery and collection of gases into the mouth, but can be easily removed and discarded if not used.
• As shown onFIG. 1, the tubing set is comprised of twoextruded tubes352 and354 for transporting CO₂nasal samples, each tube set containing two small lumens,tube355 for transporting the CO₂oral sample,audio tube356, andoxygen tube353 to transport oxygen into chamber384 (shown inFIGS. 7-9). The tubes are commercially available and preferably constructed of pliable plastic material such as extruded polyvinyl chloride. Eachextruded tube352 and354 transports CO₂samples from right and left nostrils, respectively.Sample tube352 is connected tocannula cap368adjacent oxygen tube353 on the right side. In a similararrangement sample tube354 is connected tocannula cap368 adjacentoral sample tube355 on the left side.
• Now referring toFIGS. 2 and 3,right pressure lumen357 andright sample lumen358 are located withintube352 and transport CO₂gas samples from the right nostril for pneumatic and capnometry analysis. In the same form, leftpressure lumen359 and leftsample lumen360 are located withintube354 to transport CO₂gas samples from the left nostril. In one arrangement,tube352 is adhered tooxygen tube353, and in the same manner,tube354 is adhered tooral sample tube355. The connection between tubes is designed such that the tubes can be easily separated as needed. Aseparate audio tube356 is attached to earpiece362 and is used to transport sound to the patient10's ear.
• As illustrated onFIG. 13, oral/nasal cannula connector363 is comprised of four components which when assembled together form internal chambers and channels. The components areoutlet cover394,hydrophobic filter395,gasket396, and backplate423. The components are held together byinternal latches403 which are snapped and locked ontointernal notches404.
• Referring toFIGS. 10-13 and15-18,outlet cover394 andback plate423 are made of molded rigid thermoplastic, whilegasket396 is made of an elastic, flexible material. Included inoutlet cover394 aremoisture chambers411 and412 used for trapping moisture from oral and nasal CO₂sampling gases.Outlet cover394 includes gripper snaps388 to facilitate the user securely attaching the connector assembly to the BMU interface connector (shown onFIG. 1). Left and right nasal CO₂gases are combined inrecess415 after passing through capnometry outlet channels417 (shown onFIGS. 16-18). The nasal capnometry analysis is performed on the combined gas sample in PRU200 (seeFIG. 6). Pressure analysis is also made on a combined gas sample after CO₂gases pass through pressure lines424 (FIG. 12).
• Oral capnometry analysis is performed on a CO₂gas sample, which is taken after gas has passed through oral outlet channel416 and intooral recess410 and moisture chamber411 (seeFIG. 6).Recesses410 and415 holdhydrophobic filter395 which traps moisture and allows it to drain intomoisture chambers411 and412, preventing moisture damage to other sensitive parts of the capnometry system.
• Referring toFIGS. 1 and 10-13, the distal face ofoutlet cover394 provides connectors for all cannula tubing. The distal face ofcover394 includesoxygen tube opening390, which is the connection point fortube353,audio tube opening389 which is the connection point fortube356,right tube opening392 which receivessample tube352,left tube opening393 connecting to sampletube354, andoral tube opening391 which receivesoral sample tube355. All connection points are designed to create a leak tight seal with the mating tubing. Both right and left nasal CO₂pressure lines418 (seeFIG. 16) connect to pressurelumen ports421 located inrecess420.
• As best illustrated onFIGS. 13 and 15,gasket396 is sandwiched betweenoutlet cover394 andback plate423. Its function is to create internal channels and to isolate individual flow paths. It also secureshydrophobic filter395.Hydrophobic filter395 is also held byfilter notch419 andbumps413 located onoutlet cover394 proximal face.Hydrophobic filter395 is commercially available and has the properties of being particle-blocking and hydrophobic.Back plate423 includes a number of ports that interface with the connector on BMU300 (FIG. 1) includingaudio port398,oxygen port399,oral port400, andpressure port401. Adaptor pins397 function to guide the connection betweencannula connector363 and the connector onBMU300.
• It is noted that in the detailed description of the one particular enablement of the embodiment ofFIGS. 1-18, thecannula351′, theconnector363, and theearpiece362 are single-patient-use (SPU) items.
• Drug-Delivery Cassette Assembly
• A second aspect of the invention is directed to, or a component of, or can be used by, a drug-delivery cassette assembly251, an embodiment of which is shown inFIGS. 24-40 and which, in one enablement is used in an embodiment of a procedure room unit (PRU)200 shown inFIGS. 41-57. A first expression of the embodiment ofFIGS. 24-40 is for a drug-delivery cassette assembly251 including aluer269,tubing277 and259 and a drug-delivery-cassettemain board253. Thetubing277 and259 has a drug-receiving end, which is fluidly-connectable to adrug vial250 containing a drug, and has a drug-delivery end, which is fluidly-connected to theluer269. 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 cassettemain board253 has a luer-site base portion271. Theluer269 is attachable to and detachable from the luer-site base portion271. The luer-site base portion271 has a deflectable luer-site sensor beam275 which is disposed to be deflected by theluer269 when theluer269 is attached to the luer-site base portion271 and to be undeflected when theluer259 is detached from the luer-site base portion271. The luer-site base portion271 is also referred to, in one construction, as a T-site base271, and the luer-site sensor beam275 is also referred to, in that one construction, as a T-site sensor beam275. Other constructions are left to the artisan.
• In one example of the first expression of the embodiment ofFIGS. 24-40, the cassettemain board253 is attachable to and detachable from a procedure room unit (PRU)200 (shown inFIGS. 41-57) having a luer-in-place optical sensor226 (seeFIG. 44) disposed to sense only one of the deflected luer-site sensor beam275 and the undeflected luer-site sensor beam275. In one variation, theprocedure room unit200 controls flow of the drug in thetubing277 and259 to air purge thetubing277 and259 and to deliver the drug through the tubing to a patient based at least in part on the luer-in-placeoptical sensor226 sensing or not sensing the luer-site sensor beam275. Other examples are left to the artisan.
• A broad description of a combination of the second aspect of the invention (a drug-delivery cassette assembly embodiment of which is shown inFIGS. 24-40) and a later-discussed third aspect of the invention (a procedure room unit embodiment of which is shown inFIGS. 41-57) is for a drug-delivery assembly (e.g., drug-delivery cassette assembly251 and procedure room unit200). In one expression of the combination, the drug-delivery assembly (e.g.,251 and200) includes tubing (e.g.,277 and259), a storage site (e.g., luer-site base portion271), a pump (e.g.,220 as seen inFIG. 41), and a sensor (e.g., luer-in-placeoptical sensor226, as seen inFIG. 44). The tubing (e.g.,277 and259) 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., luer269). 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 and259) 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 and259), when the tubing (e.g.,277 and259) is operatively connected to the pump (e.g.,220), to air purge the tubing (e.g.,277 and259) and to deliver the drug through the tubing (e.g.,277 and259) 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 and259) in the storage site (e.g.,271).
• 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., luer269) attached to the drug-delivery end portion of the tubing (e.g.,277 and259) 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 and259) 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 and259) by sensing the presence and/or absence of another component (e.g., the luer-site sensor beam275) which changes position between the presence and absence of the drug-delivery end portion (e.g.,269) of the tubing (e.g.,277 and259) 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.
• In one implementation of the drug-delivery assembly (e.g.,251 and200), the pump (e.g.,220) air purges the tubing (e.g.,277 and259) only when the drug-delivery end portion (e.g.,269) of the tubing (e.g.,277 and259) 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 and259) when the drug-delivery end portion (e.g.,269) of the tubing (e.g.,277 and259) is in fluid communication with the patient.
• In the same or a different implementation of the drug-delivery assembly (e.g.,251 and200), the tubing (e.g.,277 and259) 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 and259) 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 and259) 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 and259) unless the drug-delivery end portion (e.g.,269) of the tubing (e.g.,277 and259) is stored in the storage site (e.g.,271) as determined from the output of the sensor (e.g.,226).
• A second expression of the embodiment ofFIGS. 24-40 is for a drug-delivery cassette assembly251 including a drug-delivery-cassettemain board253. Adrug vial250 is attachable to the cassettemain board253. The cassettemain board253 has a deflectable drug-vial-site sensor beam267 which is disposed to be deflected by thedrug vial250 when thedrug vial250 is attached to the cassettemain board253 and to be undeflected when thedrug vial250 is unattached to the cassettemain board253. The drug-vial-site sensor beam267 is also referred to, in one construction, as aspike sensor beam267. Other constructions are left to the artisan.
• In one example of the second expression of the embodiment ofFIGS. 24-40, the cassettemain board253 is attachable to and detachable from a procedure room unit (PRU)200 (shown inFIGS. 41-57) having a drug-vial-in-place optical sensor228 (seeFIG. 44) disposed to sense only one of the deflected drug-vial-site sensor beam267 and the undeflected drug-vial-site sensor beam267. In one variation, theprocedure room unit200 controls flow of the drug from thedrug vial250 based at least in part on the drug-vial-in-placeoptical sensor228 sensing or not sensing the drug-vial-site sensor beam267.
• In the same or a different example of the second expression of the embodiment ofFIGS. 24-40, thedrug vial250 includes a drug-vial seal42, and the drug-delivery cassette assembly251 also includes aspike261 having aspike tip296 and aspike barb184. When thedrug vial250 is attached to the cassettemain board253, the drug-vial seal42 is perforated by thespike tip296 and held by thespike barb184 and the drug-vial-site sensor beam267 pushes thedrug vial250 up against thespike barb184. Such pushing up reduces drug wastage, as can be appreciated by those skilled in the art. Other examples are left to the artisan.
• A third expression of the embodiment ofFIGS. 24-40 is for a drug-delivery cassette assembly251 including a drug-delivery-cassette spike261. Adrug vial250 is attachable to thespike261. Thedrug vial250 includes a drug-vial seal42. Thespike261 has aspike tip296 and aspike barb184. When thedrug vial250 is attached to thespike261, the drug-vial seal42 is perforated by thespike tip296 and held by thespike barb184.
• A fourth expression of the embodiment ofFIGS. 24-40 is for a drug-delivery cassette assembly251 including aluer269, a drug-delivery-cassette spike261,tubing277 and259, and a drug-delivery-cassettemain board253. Thespike261 includes a drug-vial-seal-perforatingspike tip296. Thetubing277 and259 has a drug-receiving end, which is fluidly-connectable to and fluidly-disconnectable from thespike261 and has a drug-delivery end, which is fluidly-connected to theluer269. Thespike261 is attachable to and detachable from the cassettemain board253. This allows just thespike261 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.
• A fifth expression of the embodiment ofFIGS. 24-40 is for a drug-delivery cassette assembly251 including aluer269,tubing277 and259, and a drug-delivery-cassettemain board253. Thetubing277 and259 has a drug-receiving end, which is fluidly-connectable to adrug vial250 containing a drug, and has a drug-delivery end, which is fluidly-connected to theluer269. The cassettemain board253 has a luer-site base portion271. Theluer269 is attachable to and detachable from the luer-site base portion271. The luer-site base portion271 has adrip chamber273 disposed to collect any of the drug, which exits theluer269 when theluer269 is attached to the luer-site base portion271. The luer-site base portion271 is also referred to, in one construction, as a T-site base271. Other constructions are left to the artisan. In one example of the fifth expression of the embodiment ofFIGS. 24-40, the drug-delivery cassette assembly251 also includes a drug-absorbent pad273′ disposed in thedrip chamber273. Other examples are left to the artisan.
• A sixth expression of the embodiment ofFIGS. 24-40 is for a drug-delivery cassette assembly251 including aluer269 andtubing277 and259. Thetubing277 and259 includes acoiled tube259 and aflexible tube277 fluidly-connected together. Theflexible tube277 has a drug-receiving end, which is fluidly-connectable to adrug vial250 containing a drug, and thecoiled tube259 has a drug-delivery end, which is fluidly-connected to theluer269. Thecoiled tube259 is extendible by the user. In one example of the sixth expression of the embodiment ofFIGS. 24-40, thecoiled tube250 includes a plurality of coils wherein adjacent coils are releasably adhered together. This arrangement allows the user to pull out only the length ofcoiled tube259 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 coiledtube259. In the same or a different example, thecoiled tube259 has a smaller inside diameter than theflexible tube277. This reduces drug wastage remaining in thetubing277 and259 after its use and expedites removal of air during an initial purge. Other examples are left to the artisan.
• A seventh expression of the embodiment ofFIGS. 24-40 is for a drug-delivery cassette assembly251 including a drug-delivery-cassettemain board253 which is removably attachable to aprocedure room unit200 of a sedation delivery system100 (or other type ofmedical effector system100′) and which includes aperistaltic pump cutout254. In one example, of the seventh expression of the embodiment ofFIGS. 24-40, the drug-delivery cassette assembly251 also includes a drug-deliveryflexible tube277 having a substantially linear portion attached to themain board253 and spanning theperistaltic pump cutout254, wherein, when themain board253 is attached to theprocedure room unit200, the portion of theflexible tube277 is operatively connected to pump fingers of a drug-delivery peristaltic pump of theprocedure room unit200.
• An eighth expression of the embodiment ofFIGS. 24-40 is for a drug-delivery cassette assembly251 including a drug-delivery-cassettemain board253. Themain board253 has a top-left portion, a top-right portion, a bottom-right portion and a bottom-left portion. The cassettemain board253 is removably attachable to aprocedure room unit200 of a sedation delivery system100 (or other type ofmedical effector system100′). Themain board253 has aperistaltic pump cutout254 disposed between the top-left and top-right portions. Themain board253 has an air-in-line sensor cutout255 disposed between the top-right portion and the bottom-right portion.
• In one example of the eighth expression of the embodiment ofFIGS. 24-40, the drug-delivery cassette assembly251 also includes a drug-deliveryflexible tube277 having a substantially linear first portion attached to the top-left portion and the top-right portion of themain board253 and spanning theperistaltic pump cutout254 and having a substantially linear second portion attached to the top-right portion and the bottom-right portion of themain board253 and spanning the air-in-line sensor cutout255. When themain board253 is attached to theprocedure room unit200, the first portion of theflexible tube277 is operatively connected to pump fingers of a drug-delivery peristaltic pump of theprocedure room unit200 and the second portion of theflexible tube277 is operatively connected to an air-in-line sensor of theprocedure room unit200.
• In the same or a different example of the eighth expression of the embodiment ofFIGS. 24-40, the lower-left portion of themain board253 extends below the lower-right portion of themain board253 defining a pump-door-latch cutout extending to the right of the lower-left portion and below the lower-right portion of themain board253.
• In one application of any of the above-described expressions ofFIGS. 24-40, including examples, etc. thereof, the cassettemain board253 is directly attachable to a procedure room unit (PRU)200 (shown inFIGS. 41-57). Other applications are left to the artisan.
• Any one or more of the above-described expressions of the embodiment ofFIGS. 24-40, including examples, etc. thereof can be combined with any other one or more of the above-described expressions of the embodiment ofFIGS. 24-40, including examples, etc. thereof, as can be appreciated by those skilled in the art.
• The following paragraphs present a detailed description of one particular enablement of the embodiment ofFIGS. 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 ofFIGS. 24-40. In this enablement, the drug-delivery cassette assembly251 is used in conjunction with a drug-deliveryinfusion pump assembly220. In this enablement, drug-delivery cassette assembly251 is part of an integrated patient monitoring and sedation delivery system (SDS)100 (shown inFIG. 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) pump220 (seeFIG. 41), together with the drug-delivery cassette assembly251, to deliver drug(s) with variable rate infusion that achieves and maintains a desired sedation effect.
• As used herein, the term “proximal” refers to a location on the drug-delivery cassette assembly251 closest to the device using the drug-delivery cassette assembly251 and thus furthest from the patient on which the drug-delivery cassette assembly251 is used. Conversely, the term “distal” refers to a location farthest from the device using the drug-delivery cassette assembly251 and closest to the patient.
• As shown inFIGS. 24-26,cassette251 is comprised of a cassettemain board253 which in one example is molded of rigid thermoplastic having a generally flat rectangular shape, with smooth rounded corners, andrectangular cutouts254 and255 designed to permit interface with a peristaltic pump220 (seeFIG. 41) and its sensor components (e.g.,226 and228 as shown inFIG. 44). In one employment,cassette251, includingmain board253 and components are single-patient-use components and are disposable. Cassettemain board253 is comprised of a generally flat thin base designed with molded features to supportfluid communication tubes277 and259,reducer281,spike system272, andcommercial luer269.Spike system272 includesspike cap263, spike261,air vent filter295, and spikeelbow265.
• Again referring toFIGS. 24-26, cassettemain board253 has atop face252 and abottom face260, which hold secure components assembled tocassette251. Cassettemain board253 has aperistaltic pump cutout254 on the proximal side. Air-in-line sensor cutout255 and atube passage258 are apertures generally located on the sides ofmain board253. Avisible arrow sign289 is relief molded generally on the center ofmain board253, and the arrow tip indicates the insert direction ofcassette251 to the user.Alignment hole287 is a round aperture throughmain board253 used to help the user position and aligncassette251 in the pump220 (seeFIG. 41).
• As illustrated inFIGS. 24-26, in one construction cassettemain board253 is comprised of onereinforcement rib256 ontop face252 andparallel reinforcement grooves286 onbottom face260 to increase stiffness of plastic moldedstructure253 adjacent to pumpcutout254 and air-in-line sensor cutout255.Reinforcement rib256 andreinforcement grooves286 help to makemain board253 rigid for handling and use purposes.Reinforcement rib256 andreinforcement grooves286 are integrally molded as part of cassettemain board253.
• As shown inFIGS. 24 and 26, cassettemain board253 has: (a) a coiledtube base257 designed to holdcoiled tube259; (b) a T-site base271 to holdluer269; and (c) aspike bed262 to accommodatespike system272. Cassettemain board253 also includesgripper handle285.
• As illustrated onFIG. 26, gripper handle285 is an integral part of cassettemain board253, extending from the distal side to facilitate user handling. Gripper handle285 is shaped with smooth rounded corners to make it easy and comfortable to hold.Parallel ribs190 are molded on the top surface ofgripper handle285, which function to give a firm non-slip surface for gripping firmly while inserting or removingcassette251 from the pump220 (seeFIG. 41).
• As illustrated onFIGS. 24 and 26, the drug delivery system mounted oncassette251 is comprised of a set of flexible tubes assembled in fluid communication. The tubing set includes (a) a coiledtube259 and (b) aflexible tube277. The drug system also is comprised of: (c) areducer281; (d) aspike system272 mounted to spikebed262; and (e) acommercial luer269 mounted on a T-site base271. In one construction, all pieces are removably mounted in place for handling and transportation purposes.
• As shown onFIGS. 25 and 26,tube277 is made of transparent flexible plastic, such as commercially available pvc, with constant internal and external diameter cross section.Tube277 is made of a flexible resilient material to permit bending throughpassage258 and to fit intoclips279.Tube277 is generally assembled to follow the cassette external contour.Cassette251 utilizesclips279 and trackwall retainers291 to guide androute tube277, generally keeping its cross-sectional diameter constant around the corners ofcassette251 and throughpassage258. In one construction, not shown, thetrack wall retainers291 are replaced by one or moreadditional clips279.
• As illustrated onFIGS. 25 and 26,tube277 is part of the drug fluid communication system and connects at one end to (a)spike elbow265 and at the other end to (b)reducer281.Tube277 connects intospike elbow265 on the bottom side ofcassette251. Thentube277 makes a turn into the transversal direction ofcassette251, extending fromcassette bottom side260 throughtube passage258. The opposite end oftube277 is connected intoreducer281 on the top side ofcassette251.Tube277 extends freely acrosscutouts254 and255.Tube277 crosses air-in-line cutout255 andperistaltic pump cutout254.
• As shown onFIGS. 24, 26 and29,flexible tube277 is held in place by moldedclips279 located oncassette top face252.Clips279 have alternating openings to keeptube277 aligned and secured in place without distortion.Clips279 are generally curved to match the outside diameter oftube277.Clip openings270 and276 are the result of the manufacturing process that creates the clips.Double clips280secure reducer281 on cassettemain board253. In one construction,double clips280 are built with only a small clearance between them (as shown onFIG. 29) to attach firmly toreducer281 and anchor the tubing system.Clips280 also have a curved shape to match the outside contour ofreducer281 body.Double clips280 keep the two rings on the body ofreducer281 restrained in a fixed position, preventing sliding during handling or use. Thereducer281 has a flat bottom, and the cassettemain board253 has a reducer-positioning rib40 (seen inFIG. 29 but omitted fromFIG. 26 for clarity), which also helps thereducer281 stay in position when thereducer281 is secured bydouble clips280. In one example,tube277 is kept firm and straight after connection to aperistaltic pump220, which is accomplished byclips280.
• As illustrated onFIGS. 26 and 29,track wall retainers291 are molded oncassette top face252 to trap and keepconstrained tube277 as it is routed around corners. The distance between walls is such that it creates a slight interference withtube277 helping to retaintube277. As previously mentioned, in one construction, not shown, thetrack wall retainers291 are replaced by one or moreadditional clips279.
• As shown onFIG. 26,reducer281 is part of the fluid communication system, and is mounted onto the proximal part ofcassette251. 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 ofreducer281 is larger than the outlet. The outlet end is adapted to be connected to IV (intravenous) coiledtube259 while the inlet end is adapted to connect toflexible tube277.Reducer281 main body is generally cylindrical shaped with two molded rings to mount ontoclips280 to keep it fixed in place.Reducer281 also helps secure smaller diameter tubing assembly coiledtube259 and larger diameterflexible tube277 in place.
• As illustrated onFIGS. 26 and 27,coiled tube259 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 tube259, when uncoiled and extended to its maximum length, would total approximately 8 feet. This would be a sufficient length for the user to extendcoiled tube259 betweencassette251 and the patient. In one construction,coiled tube259 is stored oncassette251 in a half-cylindrical shape base257 designed to prevent movement duringcassette251 shipping and installation into thepump220. One end ofcoiled tube259 is affixed to reducer281 while the other end is connected to luer269. In use, the clinician removes luer269 from T-site bed271, disconnecting luer269 from first luer clip274 andsecond luer clip297, and pulls and uncoilstube259 as far as necessary to reach the patient. It should be noted that the inside fluid path oftube259 is minimized as compared withflexible tube277 so as to minimize wasted drug(s) remaining in the tubing after its use and to expedite removal of air during an initial purge.
• As shown onFIGS. 24, 27 and29-31, T-site base271 is designed to removablycapture luer269. T-site base271 also includes a deflective built-inbeam275, which contacts luer269 whenluer269 is fixed in place, causingbeam275 to deflect and interface with anoptical sensor226 on the Procedure Room Unit (PRU)200 (shown inFIGS. 41-57). T-site base271 further includesopen drip chamber273 used as a reservoir to capture and contain drug spillage during drug line purge. T-site base271 has built-in walls to create a sloped bed (as shown onFIG. 35) oncassette top face252. T-site base271 has two molded-in clips. First luer clip274 andsecond luer clip297 firmlysecure luer269. T-site base271 includes athin tower278.Luer269 lays on top of T-site tower278 at an inclined angle to direct excess drug spillage intochamber273.
• As illustrated onFIGS. 27 and 29,drip chamber273 is integrally part of T-site base271 and in one example is a molded part of cassettemain board253.Drip chamber273 is generally located in a central area of cassettemain board253.Drip chamber273 has a generally rectangular shape with one wall congruent to T-site tower278 and is sized to contain a specific volume of the total drug vial250 (seeFIG. 32) content.Drip chamber273 functions to prevent spillage during drug line purge and to capture any residual drug after cassette use. In one variation,drip chamber273 contains anabsorbent pad273′ to absorb all drained drug(s).
• As shown onFIGS. 25-27 and29-31, T-site sensor beam275 is molded as an integral part of cassettemain board253 and acts as a cantilever beam. The pivot point ofbeam275 is built in the distal side ofcassette251 on the top face of T-site tower278. In one construction, the free hanging end ofbeam275 extends throughcassette bottom face260 into a central longitudinal opening of T-site base262 (as shown onFIG. 31), which interfaces with T-site-in-placeoptical sensor226 located on thePRU200. The free hanging end ofbeam275 is generally designed as a “T”. One tip of the “T” touchesluer269. Whenluer269 is secured inbase271,beam275 deflects and the other T tip breaks the light beam of the optical T-site-in-place sensor226. This indicates to the PRU200 (shown inFIGS. 41-57) that luer269 is in place so that drug line purge can be performed.
• As illustrated onFIGS. 26 and 27,luer269 is commercially available and well known in the medical arts. It is made of rigid plastic. In one construction,luer269 is “T” shaped with an internal lumen in fluid communication with all three legs of the “T”. One T-leg connects to coiledtube259. Another “T” leg contains a needleless port that can be attached to IV luer fitting. The last “T” leg has a removable dust cap.
• As shown onFIGS. 26, 28 and32-34,spike bed262 is a recessed area molded into cassettemain board253 at a slight angle so that whenspike261 is assembled tomain board253, spike261 is substantially vertically oriented whencassette251 is placed into thepump220 in the PRU200 (shown inFIGS. 41-57). The vertical position ofspike261 helps thedrug vial250, when placed onspike261, to drain properly and completely.Spike bed262 has upright walls to accommodatespike wing197.Spike bed262 bottom includes two guidingpins299 extending upwards and twoapertures292 to help in aligningspike assembly261. The center area ofspike bed262 has a half-cylindrical base199 to accommodate air-vent boss177. The air-vent boss base199 generally creates a step on the round contour to holdhollow spike261 in place. In the center ofspike bed262 bottom there is a round aperture for insertingspike drug boss185. In the longitudinal direction, in the middle ofspike bed262, is the cutout ofspike sensor beam267, which has a flat curved shape.Spike sensor beam267 is fixed at the proximal side ofspike bed262, and is a cantilever beam.
• As shown onFIGS. 29-34, cantilever spike sensor beam267 (shown onFIG. 30), is an integral part of cassettemain board253. At the extreme end ofspike beam267 islower spike tab290, which is positioned to interface with an optical vial-in-place sensor228 located on thePRU200 pump220 (shown inFIG. 41).Upper spike tab288 is a second tab located in an intermediate position alongbeam267 and is positioned to interface with adrug vial250 when adrug vial250 is placed onspike261.Upper spike tab288 extends throughaperture198 onspike wing197 whenspike261 is properly assembled to cassettemain board253. Whencassette assembly251 is in place in thepump220 on the PRU200 (shown inFIGS. 41-57) and when adrug vial250 is placed onspike261, the vial makes contact withupper spike tab288 causingspike sensor beam267 to deflect sufficiently to causelower spike tab290 to interface with optical vial-in-place sensor228 located on thePRU200. This indicates to thePRU200 that adrug vial250 is properly in place so that drug line purge can be performed and so that thePRU200pump220 can deliver drug(s) to the patient.
• As shown onFIGS. 24, 26 and32-34,spike system272 is comprised ofspike cap263, spike261, and spikeelbow265.Spike cap263 helps protect clinicians from inadvertent sticks byspike tip296.Spike cap263 is removably attached on top ofspike tip296 by a latching mechanism.Spike elbow265 is removably threaded (with a luer lock) ontodrug boss185.Spike elbow265 securely attaches spike261 to cassettemain board253.Unthreading spike elbow265 fromdrug boss185 allowsspike261 to be easily removed from cassettemain board253 so thatspike261 can be properly disposed in a sharps container, minimizing overall waste volume, and saving disposal fees for the user.
• As illustrated onFIGS. 32-34, spike261 is molded of rigid thermoplastic material and contains two internal lumens running generally parallel the length ofspike261.Spike261 is generally cylindrical, having a perforatingtip296 and aspike wing197 that serves as a base to spiketip296.Spike261 includesspike barb184 that will prevent adrug vial250 from slipping off ofspike tip296.Spike tip296 includes afirst bevel186 and asecond bevel187.First bevel186 includes a drug opening, which is in fluid communication withdrug line lumen195. Similarly,second bevel187 includes an air-vial opening, which is in airway communication with air-vent lumen196. In use, a drugvial bottle seal42 is perforated byspike tip296 and held byspike barb184.
• As shown onFIGS. 26 and 32-34,drug line lumen195 is in fluid communication betweenspike tip296 anddrug channel294. External todrug channel294 isdrug boss185. On the outside ofdrug boss185 isthread193 for attachingspike elbow265. Air-vent lumen194 is in fluid communication with air-vent channel293. External to air-vent channel293 is air-vent boss177. Air-vent lumen194 is used to equalize the air pressure inside thedrug vial250, permitting fluid to flow by gravity from thedrug vial250 throughdrug line lumen195 into the drug tubing line. In one construction, there is an air-vent filter295 (as shown onFIG. 26), commercially available, that snaps into air-vent boss177. Generally air-vent filter295 has a cylindrical shape with a fine mesh feature on one side. Air-vent filter295 is permeable to passage of gases, including air, in either direction though the air-vent channel293, but precludes passage of liquid and solid materials in either direction through air-vent channel293.
• As shown onFIGS. 26, 28,32-40, spike261 has aflat wing197 base designed as a generally trapezoidal thin plate, with smooth round corners. The flat thin shape ofspike wing197 facilitates user handling and creates support forspike cap263. Twospike apertures191 are coincident withspike base apertures292 and serve to align thespike261 to the vial centering mechanism in thePRU200.Spike alignment apertures298 are used for alignment when insertingspike261 oncassette251 and engages through spike pins299, to alignspike261 onspike bed262.
• As shown onFIGS. 32-40, spike261 includessnap lock189 on top ofspike wing197.Snap lock189 is integrally formed fromspike wing197.Snap lock189 interfaces withspike latch284 located onspike cap263 to retainspike cap263 onspike261.
• As illustrated onFIGS. 24 and 32-40,spike cap263 is made of rigid thermoplastic and is a safety protection device forspike system272.Spike cap263 includes coveringhead176, which is a hollow body, used to coverspike tip296. Spike hollow181 has a generally oblong shape and facilitates the assembly ofspike cap263 overspike tip296.Spike cap263 includes cap handle182 to facilitate easy handling by the user. On each side of cap handle182 are located gripperribs178. A latching mechanism includesspike latch284 and two supporting arms,first arm179 andsecond arm180, molded integrally on both sides of coveringhead176.Spike latch284 has a spring-like property and is capable of deflecting normal to the axis of coveringhead176. Whenspike cap263 is assembled overspike tip296,latch284 is deflected bysnap lock189 located onspike296, causinglip183 to lock onto the edge ofsnap lock189.First arm179 andsecond arm180 preventspike cap263 from tilting. As shown inFIGS. 24, 26,28-31, the cassettemain board253 includes two cap-attachingribs38 which provide for a removable snap-fit attachment therebetween of the cap handle182 of thespike cap263 to the cassettemain board253. A brisk, quick upward force oncap handle182 will causespike cap263 to release fromspike261 and from cap-attachingribs38.
• As shown onFIGS. 25 and 26,spike elbow265 is made of a rigid thermoplastic and is generally cylindrical in shape with two openings connected by internalfluid channel264. One opening offluid channel264 connects totube277. The other opening ofchannel264 is in fluid communication withdrug channel294 located inspike261, and permits drug(s) to flow by gravity from a spiked vial throughdrug lumen195, and through totube277.Spike elbow265 includes an internally threaded ring to permitspike elbow265 to be removably attached to spike boss185 (SeeFIG. 33). Whenspike261 is properly assembled to cassettemain board253, spike elbow retainsspike261.
• Drug delivery cassette251 is for single patient use (SPU) and is manually loaded in a pump cassette deck219 on a Procedure Room Unit (PRU)200 (shown inFIGS. 41-57). The pump cassette deck219 has a hinged door that serves to presscassette251 against theperistaltic pump220.Cassette251 contains intravenous tubing that is connected to a patient's catheter.
• Procedure Room Unit
• A third aspect of the invention is directed to, or a component of, or can be used by, aprocedure room unit200, an embodiment of which is shown inFIGS. 41-57. A first expression of the embodiment ofFIGS. 41-57 is for a drug-deliveryinfusion pump assembly220 including a drug-deliveryinfusion pump housing239, a drug-delivery cassette assembly251 (an embodiment of which has been previously discussed and shown in greater detail inFIGS. 24-40), and a pump-housing door201. The drug-delivery cassette assembly251 is attachable to theinfusion pump housing239 and has a drug-vial spike261 (SeeFIG. 32). The pump-housing door201 is attached to theinfusion pump housing239, has door-open and door-closed positions, and has drug-vial-aligningfingers44. The drug-vial-aligningfingers44 center and align differentdiameter drug vials250 when: thecassette assembly251 is attached to theinfusion pump housing239; the pump-housing door201 is in the door-closed position; and adrug vial250 is inserted between the drug-vial-aligningfingers44 for engagement with thespike261.
• In one construction of the first expression of the embodiment ofFIGS. 41-57, the drug-vial-aligningfingers44 center and align ten and twenty cubic-centimeter drug vials250 having different outside diameters and having the same or different lengths. In one variation, the drug-vial-centeringfingers44 consist essentially of two resilient, concave and opposing fingers. In the same or a different construction, the pump-housing door201 is rotatably attached to theinfusion pump housing239 and is rotatable between the door-open and door-closed positions. Other constructions and variations are left to the artisan.
• In one example of the first expression of the embodiment ofFIGS. 41-57, thecassette assembly251 is attachable to, and removable from, theinfusion pump housing239 when the pump-housing door201 is in the door-open position. In the same or a different example, the drug-deliveryinfusion pump assembly220 also includes a drug-delivery peristaltic pump232 disposed in theinfusion pump housing239 and havingpump fingers229. In this example, thecassette assembly251 is operatively connectable to thepump fingers229 when thecassette assembly251 is attached to theinfusion pump housing239 and the pump-housing door201 is in the door-open position.
• In one application of the first expression of the embodiment ofFIGS. 41-57, the drug-deliveryinfusion pump assembly220 is a part of a procedure room unit (PRU)200 of a sedation delivery system (SDS)100 (or other type ofmedical effector system100′) wherein the SDS100 (or other type ofmedical effector system100′) also has a bedside monitoring unit (BMU)300 and anumbilical cable160. In this application, theBMU300 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, thePRU200 is used during a medical procedure and for receiving patient parameters from theBMU300 and has a display screen for displaying patient parameters. In this application, theumbilical cable160 is used for communicating patient parameters from theBMU300 to thePRU200.
• A second expression of the embodiment ofFIGS. 41-57 is for a drug-deliveryinfusion pump assembly220 and drug-delivery cassette assembly251 combination including a drug-deliveryinfusion pump housing239, a drug-delivery cassette assembly251, a pump-housing door201, and a pump-housing door lock205/222. Thecassette assembly251 is attachable to theinfusion pump housing239, has aluer269, and has a drug-delivery-cassettemain board253 including a luer-site base portion271. Theluer269 is attachable to and detachable from the luer-site base portion271. The pump-housing door201 is attached to theinfusion pump housing239 and has door-open and door-closed positions. The pump-housing door lock205/222, when thecassette assembly251 is attached to theinfusion pump housing239, unlocks the pump-housing door201 when theluer269 is attached to the luer-site base portion271.
• In one enablement of the second expression of the embodiment ofFIGS. 41-57, thelock205/222 includes a pump-door latch205 and adoor latch solenoid222 operatively connected to the pump-door latch205. Other enablements are left to the artisan. It is noted that the pump-housing door201 can be opened to remove thecassette assembly251 when theluer269 is returned to the luer-site base portion271 at the end of a medical procedure.
• A third expression of the embodiment ofFIGS. 41-57 is for a sedation-delivery-system procedure room unit200 (or other type of medical-effector-systemprocedure room unit200′) including acapnometer140 and202 and abarcode reader assembly455. Thecapnometer140 and202 is adapted to receive directly or indirectly respiratory gas obtained from a single-patient-use cannula351′ which is disposable on the face of a patient. Thebarcode reader assembly455 is adapted to read a barcode of a package containing thecannula351′ and/or a barcode of thecannula351′.
• An additional third expression of the embodiment ofFIGS. 41-57 is for a sedation-delivery-system procedure room unit200 (or other type of medical-effector-systemprocedure room unit200′) including a drug-deliveryinfusion pump housing239 and abarcode reader assembly455. The drug-deliveryinfusion pump housing239 is adapted to receive a single-patient-use drug-delivery cassette assembly251. Thebarcode reader assembly455 is adapted to read a barcode of a package containing the drug-delivery cassette assembly251 and/or a barcode of the drug-delivery cassette assembly251.
• In a further third expression of the embodiment ofFIGS. 41-57, thecassette assembly251 is adapted to receive a single-patient-use drug vial250 containing a drug (such as, but not limited to, a sedation drug), and thebarcode reader assembly455 is adapted to read a barcode of thedrug vial250 and/or a barcode of a package containing thedrug vial250.
• In one employment of the third expression, the additional third expression and/or the further third expression of the embodiment ofFIGS. 41-57, theprocedure room unit200 uses thebarcode reader assembly455 to prevent multiple use of a single-patient-use item such as the drug-delivery cassette assembly251, thecannula351′, and thedrug vial250 in theprocedure room unit200. In another employment, theprocedure room unit200 uses thebarcode reader assembly455 to match single-patient-use items to a particular patient. Other employments are left to the artisan.
• A fourth expression of the embodiment ofFIGS. 41-57 is for a sedation delivery system100 (or other type ofmedical effector system100′) including a microprocessor-basedbedside monitoring unit300, a microprocessor-basedprocedure room unit200, and anumbilical cable160. Thebedside monitoring unit300 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. Theprocedure room unit200 has a drug-deliveryflow control assembly220′ (or other type ofmedical effector220″), and has ahost controller204 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-deliveryflow control assembly220′ (or other type ofmedical effector220″) based at least in part on the program inputs. Theumbilical cable160 has a first end attached or attachable to the second series of connection points of thebedside monitoring unit300 and has a second end attached or attachable to theprocedure room unit200. At least one of the first and second ends of theumbilical cable160 is detachable from the correspondingbedside monitoring unit300 or theprocedure room unit200. Theprocedure room unit200 includes an Ethernet and/or amodem connector471/470 operatively connected to thehost controller204.
• In one arrangement of the fourth expression of the embodiment ofFIGS. 41-57, the drug-deliveryflow control assembly220′ includes a drug-deliveryinfusion pump assembly220 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.
• In one employment of the fourth expression of the embodiment ofFIGS. 41-57, the Ethernet and/ormodem connector471/470 is used for remote software updates of programs residing in the memory of thehost controller204 of theprocedure room unit200, 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 thehost controller204 including, in one example, all memory of the system input/output board451 of the host controller and all memory of theprocessor board452 of the host controller. In the same or a different employment, thehost controller204 of theprocedure room unit200 uses the Ethernet and/ormodem connector471/470 to send patient data to a remote computer for data management purposes. Other employments are left to the artisan. In one construction, theprocedure room unit200 has only anEthernet connector471 and not amodem connector470. In a different construction, only amodem interface470 and not anEthernet interface471 is present. In another construction, both an Ethernet and amodem interface471 and470 are present. In one enablement of the fourth expression of the embodiment ofFIGS. 41-57, theprocedure room unit200 includes amonitor display442 for displaying at least some of the program inputs and the status of the drug-deliveryflow control assembly220′ (or other type ofmedical effector220″).
• A fifth expression of the embodiment ofFIGS. 41-57 is for a sedation delivery system100 (or other type ofmedical effector system100′) including a microprocessor-basedbedside monitoring unit300, a microprocessor-basedprocedure room unit200, and anumbilical cable160. Thebedside monitoring unit300 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. Theprocedure room unit200 has a drug-deliveryflow control assembly220′ (or other type ofmedical effector220″), and has ahost controller204 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-deliveryflow control assembly220′ (or other type ofmedical effector220″) based at least in part on the program inputs. Theumbilical cable160 has a first end attached or attachable to the second series of connection points of thebedside monitoring unit300 and has a second end attached or attachable to theprocedure room unit200. At least one of the first and second ends of theumbilical cable160 is detachable from the correspondingbedside monitoring unit300 or theprocedure room unit200. Thehost controller204 of theprocedure room unit200 includes Health Level Seven application protocol to electronically send and/or receive communications to and/or from a remote computer.
• In one employment of the fifth expression of the embodiment ofFIGS. 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) theprocedure room unit200. Other applications are left to the artisan.
• A sixth expression of the embodiment ofFIGS. 41-57 is for a sedation delivery system100 (or other type ofmedical effector system100′) including a microprocessor-basedbedside monitoring unit300, a microprocessor-basedprocedure room unit200, and anumbilical cable160. Thebedside monitoring unit300 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. Theprocedure room unit200 has a drug-deliveryflow control assembly220′ (or other type ofmedical effector220″), and has ahost controller204 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-deliveryflow control assembly220′ (or other type ofend effector220″) based at least in part on the program inputs. Theumbilical cable160 has a first end attached or attachable to the second series of connection points of thebedside monitoring unit300 and has a second end attached or attachable to theprocedure room unit200. At least one of the first and second ends of theumbilical cable160 is detachable from the correspondingbedside monitoring unit300 or theprocedure room unit200. Theprocedure room unit200 includes aprinter454 operatively connected to thehost controller204.
• In one employment of the sixth expression of the embodiment ofFIGS. 41-57, theprinter454 is used to create a printed patient record of the role of the sedation delivery system100 (or other type ofmedical effector system100′) during the medical procedure undergone by the patient. In one example of the sixth expression of the embodiment ofFIGS. 36-52, theprocedure room unit200 includes a procedure-room-unit console444, wherein theconsole444 contains the drug-deliveryflow control assembly220′ (or other type ofmedical effector220″), thehost controller204, and theprinter454. In one construction, theprinter454 is a thermal printer.
• A seventh expression of the embodiment ofFIGS. 41-57 is for asedation delivery system100 comprising a microprocessor-basedbedside monitoring unit300, a microprocessor-basedprocedure room unit200, and anumbilical cable160. Thebedside monitoring unit300 has a bedside-monitoring-unit host controller301 (SeeFIG. 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. Theprocedure room unit200 has a procedure-room-unit host controller204, which contains a second program. The second program performs the steps of: issuing requests through thebedside monitoring unit300 to a sedated patient for a sedated patient response; receiving a signal through thebedside monitoring unit300 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. Theumbilical cable160 has a first end attached or attachable to thebedside monitoring unit300 and has a second end attached or attachable to theprocedure room unit200. At least one of the first and second ends is detachable from the correspondingbedside monitoring unit300 or theprocedure room unit200.
• In one example of the seventh expression of the embodiment ofFIGS. 41-57, theprocedure room unit200 has a drug-deliveryinfusion pump assembly220. The drug-deliveryinfusion pump assembly220 is controlled by the procedure-room-unit host controller204 based at least in part on the response time difference. In the same or a different example, thesedation delivery system100 includes acannula assembly145 disposable on the face of a patient and having a respiratorygas sampling tube354,352 and355 (SeeFIG. 1). The respiratorygas sampling tube354,352 and355 (SeeFIG. 1) is connectable to thebedside monitoring unit300. Theprocedure room unit200 includes acapnometer202 and140 having a capnometer output signal, and theumbilical cable160 is operatively connectable to the respiratorygas sampling tube354,352 and355 and thecapnometer202 and140. The drug-deliveryinfusion pump assembly220 is controlled at least in part by the capnometer output signal.
• In one employment of the seventh expression of the embodiment ofFIGS. 41-57, thebedside monitoring unit300 uses an audio earpiece362 (SeeFIG. 1) to provide the patient10 with requests to squeeze an automated-responsiveness-monitor (ARM) handset342 (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 thebedside monitoring unit300 in a pre-procedure room to train the non-sedated patient to use theARM handset342 and to calculate the non-sedated response time. The requests are issued by the procedure room unit200 (and transmitted to thebedside monitoring unit300 through the umbilical cable160) when the patient undergoes sedation in the procedure room to calculate sedated response times throughout the procedure. The requests are issued by thebedside monitoring unit300 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.
• A still further example would be to utilize theARM handset342 in place of a call button. While patients are in the pre-procedure or post-procedure room, a long squeeze or rapid squeezes onARM handset342 would be detected byBMU300 as a request for assistance.BMU300 would then log the request, post it on the BMU GUI212 (SeeFIG. 60) and illuminate the light bar208 (SeeFIG. 60) in an appropriate color or flashing scheme.
• A further example isBMU300 detecting a low respiration rate, apnea condition, or low SpO₂and communicating this status to the patient.BMU300 would send an audio request, such as “TAKE A DEEP BREATH” to the patient by way ofaudio earpiece362, 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.
• An eighth expression of the embodiment ofFIGS. 41-57 is for a sedation-delivery-system procedure room unit200 (or other type of medical-effector-systemprocedure room unit200′) comprising a procedure-room-unit host controller204 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 controller204 controls a flow of oxygen to the patient based on the calculated oxygen flow rate.
• In the eighth expression of the embodiment ofFIGS. 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.
• A first extension of the eighth expression of the embodiment ofFIGS. 41-57 is for a sedation delivery system100 (or other type of medical-effector system100′) including the sedation-delivery-system procedure room unit200 (or other type of medical-effector-systemprocedure room unit200′) as described in the previous paragraph, including abedside monitoring unit300, and including anumbilical cable160. Theumbilical cable160 has a first end attached or attachable to thebedside monitoring unit300 and has a second end attached or attachable to theprocedure room unit200. At least one of the first and second ends is detachable from the correspondingbedside monitoring unit300 or theprocedure room unit200. When theumbilical cable160 is attached to theprocedure room unit200 and thebedside monitoring unit300, the pulse-oximeter signal flows from the patient through thebedside monitoring unit300 and through theumbilical cable160 to theprocedure room unit200 and the flow of oxygen flows through theumbilical cable160 and thebedside monitoring unit300 to the patient.
• A ninth expression of the embodiment ofFIGS. 41-57 is for medical oxygen-delivery apparatus including an oxygen-delivery manifold206 having an oxygen-delivery flow path, a fixed-size-orifice flow restrictor489, and a variable-size-orifice flow restrictor480. 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 acannula351′ disposable on the face of a patient. The fixed-size-orifice flow restrictor489 is disposed in the flow path downstream of the flow-path inlet, and the variable-size-orifice flow restrictor480 is disposed in the flow path downstream of the fixed-size-orifice flow restrictor489.
• In one example of the ninth expression of the embodiment ofFIGS. 41-57, the medical oxygen-delivery apparatus also includes a highside pressure sensor487 in fluid communication with the flow path at a first location disposed between the flow-path inlet and the fixed-size-orifice flow restrictor489 and includes adifferential pressure sensor479 in fluid communication with the flow path at an entrance location disposed between the first location and the fixed-size-orifice flow restrictor489 and at an exit location disposed between the fixed-size-orifice flow restrictor489 and the variable-size-orifice flow restrictor480. The orifice size of the variable-size-orifice flow restrictor480 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 restrictor480 is a variable-size-orifice solenoid. In one application, the oxygen-delivery manifold206 is a subassembly of aprocedure room unit200 of a sedation delivery system100 (or other type ofmedical effector system100′).
• A tenth expression of the embodiment ofFIGS. 41-57 is for a sedation-delivery-system procedure room unit200 (or other medical-effector-systemprocedure room unit200′) including a procedure-room-unit host controller204, 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-deliveryoral prong369″/371″ of acannula assembly145 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 prong422′ and422″ of thecannula assembly145 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 prong422′ or422″ 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.
• In one example of the tenth expression of the embodiment ofFIGS. 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.
• In one enablement of the tenth expression of the embodiment ofFIGS. 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-samplingnasal prong364 and365 of thecannula assembly145.
• A first alternate tenth expression of the embodiment ofFIGS. 41-57 is for a medical-effector-systemprocedure room unit200′ (such as a sedation-delivery-systemprocedure room unit200′) including a procedure-room-unit host controller204 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-deliveryoral prong369″/371″ of acannula assembly145 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 prong422′ and422″ of thecannula assembly145 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 prong422′ and422″ 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.
• In one enablement of the first alternate tenth expression of the embodiment ofFIGS. 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.
• In one example of the first alternate tenth expression of the embodiment ofFIGS. 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.
• A second alternate tenth expression of the embodiment ofFIGS. 41-57 is for a medical-effector-systemprocedure room unit200′ (such as a sedation-delivery-system procedure room unit200) including a procedure-room-unit host controller204 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 prong422′ and422″ of acannula assembly145 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 prong422′ and422″ 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.
• In one enablement of the second alternate tenth expression of the embodiment ofFIGS. 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.
• An eleventh expression of the embodiment ofFIGS. 41-57 is for medical oxygen-delivery apparatus including an oxygen-delivery manifold206. The oxygen-delivery manifold206 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 acannula351′ disposable on the face of a patient. The oxygen-sampling flow path includes anoxygen sensor482, which detects hypoxic gas.
• In one example of the eleventh expression of the embodiment ofFIGS. 41-57, anoxygen sample solenoid481 fluidly connects the oxygen-sampling flow path to the oxygen-delivery flow path. In one implementation, a detection of hypoxic (low oxygen) gas by theoxygen sensor482 is used to issue a user alert to check the source of oxygen. In one employment, the oxygen-delivery manifold206 is a subassembly of aprocedure room unit200 of a sedation delivery system100 (or other type of medical-effector system100′).
• A twelfth expression of the embodiment ofFIGS. 41-57 is for a sedation-delivery-system procedure room unit200 (or other type of medical-effector-systemprocedure room unit200′) including a procedure-room-unit host controller204 and acapnometer140 and202. Thecapnometer140 and202 has a capnometer gas input which receives directly or indirectly respiratory gas obtained from acannula351′ which is disposable on the face of a patient. Thecapnometer140 and202 also has a capnometer signal output operatively connected to the procedure-room-unit host controller204. The procedure-room-unit host controller204 issues a user alert that thecapnometer140 and202 is fluidly connected and/or not fluidly connected to thecannula351′ based at least in part on the capnometer signal output of thecapnometer140 and202.
• In one example of the twelfth expression of the embodiment ofFIGS. 41-57, the capnometer input receives indirectly respiratory gas obtained from thecannula351′ through an interveningbedside monitoring unit300. Thebedside monitoring unit300 is attachable to thecannula351′ and is attached or attachable to a first end of anumbilical cable160. Theumbilical cable160 has a second end attached or attachable to theprocedure room unit200. At least one of the first and second ends is detachable from the correspondingbedside monitoring unit300 or theprocedure room unit200. Typically, in this example, a detachedumbilical cable160 would be responsible for most user alerts from the procedure-room-unit host controller204 that thecapnometer140 and202 is not fluidly connected to thecannula351′. In one enablement, the procedure-room-unit host controller204 determines that thecapnometer140 and202 is fluidly connected to thecannula351′ 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 thecapnometer140 and202).
• A thirteenth expression of the embodiment ofFIGS. 41-57 is for a sedation-delivery-system procedure room unit200 (or other type of medical-effector-systemprocedure room unit200′) including a sedation-delivery-system procedure-room-unit console444 (or other type of medical-effector-system procedure-room-unit console444′) having aconsole fan456 and acapnometer subassembly140/202 and141/142. Theconsole fan456 moves air into, through, and out of the procedure-room-unit console444 (or444′). Thecapnometer subassembly140/202 and141/142 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 theconsole fan456.
• In one example of the thirteenth expression of the embodiment ofFIGS. 41-57, thecapnometer subassembly140/202 and141/142 has acapnometer140 and202 and acapnometer pump141 and142 operatively connected to thecapnometer140 and202. 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.
• In one extension of the thirteenth expression of the embodiment ofFIGS. 41-57, a sedation delivery system100 (or other type of medical-effector system100′) includes the sedation-delivery-system procedure room unit200 (or other type of medical-effector-systemprocedure room unit200′) described in the second previous paragraph, includes abedside monitoring unit300, and includes anumbilical cable160. Theumbilical cable160 has a first end attached or attachable to thebedside monitoring unit300 and has a second end attached or attachable to theprocedure room unit200. At least one of the first and second ends is detachable from the correspondingbedside monitoring unit300 or theprocedure room unit200.
• A fourteenth expression of the embodiment ofFIGS. 41-57 is for a sedation-delivery-system procedure room unit200 (or other type of medical-effector-system procedure room unit200) including a procedure-room-unit host controller204, acapnometer140 and202, anoxygen manifold206, and a lowside pressure sensor488. Thecapnometer140 and202 has a capnometer gas input which receives directly or indirectly respiratory gas obtained from acannula351′ which is disposable on the face of a patient and has a capnometer signal output operatively connected to the procedure-room-unit host controller204. Theoxygen manifold206 has an oxygen-delivery flow path including in series a flow-path inlet fluidly-connectable to a source of pressurized oxygen, aflow restrictor489 and480, and a flow-path outlet fluidly-connectable to thecannula351′. The lowside pressure sensor488 is in fluid communication with the flow-path outlet, is disposed downstream of any oxygen-manifold flow restrictor489 and480, and has a low-side pressure signal output operatively connected to the procedure-room-unit host controller204. The procedure-room-unit host controller204 issues a user alert that thecapnometer140 and202 is fluidly connected and/or not fluidly connected to thecannula351′ based at least in part on the capnometer signal output of thecapnometer140 and202 and the low-side pressure signal output of the lowside pressure sensor488.
• In one example of the fourteenth expression of the embodiment ofFIGS. 41-57, the capnometer input receives indirectly respiratory gas obtained from thecannula351′ through an interveningbedside monitoring unit300 which is attachable to thecannula351′ and attached or attachable to a first end of anumbilical cable160 having a second end attached or attachable to theprocedure room unit200. The flow-path outlet of theoxygen manifold206 is indirectly fluidly-connected to thecannula351′ through thebedside monitoring unit300 and theumbilical cable160. At least one of the first and second ends is detachable from the correspondingbedside monitoring unit300 or theprocedure room unit200.
• A fifteenth expression of the embodiment ofFIGS. 41-57 is for a sedation-delivery-system procedure room unit200 (or other type of medical-effector-systemprocedure room unit200′) including a procedure-room-unit host controller204, acapnometer140 and202 and acapnometer pump141 and142. Thecapnometer140 and202 has a capnometer gas input which receives directly or indirectly respiratory gas obtained from acannula351′ which is disposable on the face of a patient. Thecapnometer140 and202 also has a capnometer signal output operatively connected to the procedure-room-unit host controller204. Thecapnometer pump141 and142 is operatively connected to thecapnometer140 and202 and is controlled by the procedure-room-unit host controller204. The procedure-room-unit host controller204 determines that thecapnometer140 and202 is fluidly connected and/or not fluidly connected to thecannula351′ based at least in part on the capnometer signal output of thecapnometer140 and202. The procedure-room-unit host controller204 shuts off, with or without a time delay, thecapnometer pump141 and142 when thecapnometer140 and202 is not fluidly connected to thecannula351′. In one employment, shutting off thecapnometer pump141 and142 during times when thecannula351′ is not in use avoids pollutants, impurities, etc. in the air from contaminating thecapnometer140 and202 during such times.
• In one example of the fifteenth expression of the embodiment ofFIGS. 41-57, the capnometer input receives indirectly respiratory gas obtained from thecannula351′ through an interveningbedside monitoring unit300. Thebedside monitoring unit300 is attachable to thecannula351′ and is attached or attachable to a first end of anumbilical cable160. Theumbilical cable160 has a second end attached or attachable to theprocedure room unit200. At least one of the first and second ends is detachable from the correspondingbedside monitoring unit300 or theprocedure room unit200.
• A sixteenth expression of the embodiment ofFIGS. 41-57 is for a sedation-delivery-system procedure room unit200 (or other type of medical-effector-systemprocedure room unit200′) including a procedure-room-unit host controller204, acapnometer140 and202, and an ambient-air pressure sensor46. Thecapnometer140 and202 has a capnometer gas input which receives directly or indirectly respiratory gas obtained from acannula351′ which is disposable on the face of a patient. Thecapnometer140 and202 has a capnometer signal output operatively connected to the procedure-room-unit host controller204. The ambient-air pressure sensor46 has an ambient-air-pressure-sensor signal output operatively connected to the procedure-room-unit host controller204. The procedure-room-unit host controller204 determines if the sedation-delivery-system procedure room unit200 (or other type of medical-effector-systemprocedure room unit200′) 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 sensor46. The procedure-room-unit host controller204 issues a capnometer-calibration user alert when the sedation-delivery-system procedure room unit200 (or other type of medical-effector-systemprocedure room unit200′) has been moved to a new location having an altitude difference greater than the predetermined altitude difference.
• In one example of the sixteenth expression of the embodiment ofFIGS. 41-57, the capnometer input receives indirectly respiratory gas obtained from thecannula351′ through an interveningbedside monitoring unit300. Thebedside monitoring unit300 is attachable to thecannula351′ and is attached or attachable to a first end of anumbilical cable160. Theumbilical cable160 has a second end attached or attachable to theprocedure room unit200. At least one of the first and second ends is detachable from the correspondingbedside monitoring unit300 or theprocedure room unit200.
• A seventeenth expression of the embodiment ofFIGS. 41-57 is for a sedation-delivery-system procedure room unit200 (or other type of medical-effector-systemprocedure room unit200′) including a procedure-room-unit host controller204, acannula351′, and anoxygen manifold206. Thecannula351′ is disposable on the face of a patient and has a respiratory-gas-sample output operatively connectable to the procedure-room-unit host controller204. Theoxygen manifold206 has a flow-path outlet fluidly-connectable to thecannula351′ and has a variable-size-orifice flow restrictor480 operatively connected to, and disposed upstream of, the flow-path outlet. The procedure-room-unit host controller204 determines when the patient is first breathing with adisposed cannula351′ based at least on the respiratory-gas-sample output of thecannula351′ and opens the variable-size-orifice flow restrictor480 when the patient is first determined to be breathing with adisposed cannula351′.
• In one enablement of the seventeenth expression of the embodiment ofFIGS. 41-57, the respiratory-gas-sample output of thecannula351′ is operatively connected to the procedure-room-unit host controller204 via a pressure transducer (such as nasal pressure transducer47) and/or through acapnometer140 and202. In the same or a different enablement, the variable-size-orifice flow restrictor480 is a variable-size-orifice solenoid.
• In one application of any of the above-described expressions ofFIGS. 41-57, including examples, etc. thereof, theprocedure room unit200 is directly attachable to abedside monitoring unit300. Other applications are left to the artisan.
• Any one or more of the above-described expressions of the embodiment ofFIGS. 41-57, including examples, etc. thereof can be combined with any other one or more of the above-described expressions of the embodiment ofFIGS. 41-57, including examples, etc. thereof, as can be appreciated by those skilled in the art.
• In an alternate embodiment, as shown inFIG. 58, aprocedure room unit50 includes an energy-deliverymedical effector52. An expression of the embodiment ofFIG. 58 is for amedical effector system54 including a microprocessor-basedbedside monitoring unit56, a microprocessor-basedprocedure room unit50, and anumbilical cable58. Thebedside monitoring unit56 has a first series of connection points60 for receiving patient inputs from patient monitoring connections, has a second series of connection points62 for outputting patient outputs based on the received inputs, and has adisplay screen64 for displaying at least some of the patient outputs. Theprocedure room unit50 has an energy-deliverymedical effector52, and has ahost controller66 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-deliverymedical effector52 based at least in part on the program inputs. Theumbilical cable58 has a first end attached or attachable to the second series of connection points62 of thebedside monitoring unit56 and has a second end attached or attachable to theprocedure room unit50. At least one of the first and second ends is detachable from the correspondingbedside monitoring unit56 or theprocedure room unit50. In one example, the energy-deliverymedical effector52 includes at least onemagnetic flux generator68 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-onemagnetic flux generator68 includes acoil70.
• FIG. 59 shows an embodiment of amedical effector subsystem306. A first expression of the embodiment ofFIG. 59 is for amedical effector subsystem306 including a drug-delivery tube308, apressure sensor324, and amemory326. The drug-delivery tube308 is adapted to contain therein adrug328 having a variable commanded flow rate and is disposable to deliver the drug to apatient336. Thepressure sensor324 has anoutput signal338 and is adapted to sense internal pressure of the drug-delivery tube308. Thememory326 contains an occlusion program which when running on aprocessor344 is operatively connected to theoutput signal338 of thepressure sensor324. The occlusion program has a variable pressure alarm setting and alerts a user of an occluded drug-delivery tube308 when theoutput signal338 of thepressure sensor324 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 thedrug328.
• The term “occluded” includes partially occluded and completely occluded. Causes of an occluded drug-delivery tube308 include, without limitation, a bent, twisted, squeezed, and/or blocked tube. In one operation of the first expression of the embodiment ofFIG. 59, thedrug328 is a pumped drug, which is pumped at the variable commanded flow rate. In this operation, when the drug-delivery tube308 is occluded, the continued pumping of thedrug328 increases the internal pressure of the drug-delivery tube308. 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).
• In one implementation of the first expression of the embodiment ofFIG. 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.
• In one employment of the first expression of the embodiment ofFIG. 59, the drug-delivery tube308 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.
• In one constuction of the first expression of the embodiment ofFIG. 59, thepressure sensor324 includes a pressure-sensitive input portion346 and the drug-delivery tube308 has an imperforateoutside surface portion348. In this construction, theinput portion346 of thepressure sensor324 is disposed in contact with the imperforateoutside surface portion348 of the drug-delivery tube308. 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.
• In one enablement of the first expression of the embodiment ofFIG. 59, thememory326 and theprocessor344 are components of a host controller of a procedure room unit (such ashost controller204 of the previously-described procedure room unit200). In one variation, thememory326 also contains a drug delivery algorithm, such as the previously mentioned Dosage Controller (DC) algorithm, which when running on theprocessor344 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.
• In one application of the first expression of the embodiment ofFIG. 59, themedical effector subsystem306 also includes aninfusion pump350, which is adapted to receive the variable commanded flow rate. Theinfusion pump350 hasperistaltic pump fingers372. Theperistaltic pump fingers372 are disposed to interact with the drug-delivery tube308 and are controllable to pump thedrug328 at the variable commanded flow rate.
• A second expression of the embodiment ofFIG. 59 is for amedical effector subsystem306 including a drug-delivery tube308, apressure sensor324, and amemory326. The drug-delivery tube308 is adapted to contain therein adrug328 having a variable commanded flow rate, is disposable to deliver thedrug328 to apatient336, and includes an imperforateoutside surface portion348. Thepressure sensor324 has anoutput signal338 and includes a pressure-sensitive input portion346 disposed in contact with the imperforateoutside surface portion348 of the drug-delivery tube308. Thememory326 contains an occlusion program which when running on aprocessor344 is operatively connected to theoutput signal338 of thepressure sensor324. The occlusion program has a variable pressure alarm setting and alerts a user of an occluded drug-delivery tube308 when theoutput signal338 of thepressure sensor324 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 thedrug328.
• A third expression of the embodiment ofFIG. 59 is for amedical effector subsystem306 including a drug-delivery tube308, apressure sensor324, and anocclusion alarm unit380. The drug-delivery tube308 is adapted to contain therein adrug328 having a variable commanded flow rate and is disposable to deliver thedrug328 to apatient336. Thepressure sensor324 has anoutput signal338 and is adapted to sense internal pressure of the drug-delivery tube308. Theocclusion alarm unit380 is operatively connected to theoutput signal338 of thepressure sensor324 and has a variable pressure alarm setting to alert a user of an occluded drug-delivery tube308 when theoutput signal338 of thepressure sensor324 exceeds the variable pressure alarm setting. Theocclusion alarm unit380 changes the variable pressure alarm setting based at least in part, and directly or indirectly, on the variable commanded flow rate of thedrug328. In one example, theocclusion alarm unit380 includes the previously-describedmemory326 andprocessor344 of a procedure-room-unit host controller (such as previously-described host controller204) and alerts the user through a popup window on a monitor (such as procedure-room-unit monitor441, as shown inFIG. 48). In another example, not shown, the occlusion alarm unit does not involve a processor of a procedure-room-unit host controller.
• A fourth expression of the embodiment ofFIG. 59 is for a drug-deliveryinfusion pump subassembly382 including a drug-delivery tube308,peristaltic pump fingers372, apressure sensor324, and anocclusion alarm unit380. The drug-delivery tube308 is adapted to contain therein adrug328 and is disposable to deliver thedrug328 to apatient336. Theperistaltic pump fingers372 are disposed to interact with the drug-delivery tube308 and are controllable to pump thedrug328 at a commanded flow rate. Thepressure sensor324 has anoutput signal338 and is adapted to sense internal pressure of the drug-delivery tube308 downstream of theperistaltic pump fingers372. Theocclusion alarm unit380 is operatively connected to theoutput signal338 of thepressure sensor324 and has a variable pressure alarm setting to alert a user of an occluded drug-delivery tube308 when theoutput signal338 of thepressure sensor324 exceeds the variable pressure alarm setting. Theocclusion alarm unit380 changes the variable pressure alarm setting based entirely, and directly, on the variable commanded flow rate of the drug.
• In one implementation of the fourth expression of the embodiment ofFIG. 59, the drug-delivery tube308, theperistaltic pump fingers372, thepressure sensor324, and theocclusion alarm unit380 are components of a procedure room unit of a medical effector system (such as theprocedure room unit200 of the previously-describedmedical effector system100′). In one example of the fourth expression of the embodiment ofFIG. 59, theocclusion alarm unit380 includes the previously-describedmemory326 andprocessor344 and alerts the user through a popup window and/or a flashing visual alarm displayed on a monitor (such as procedure-room-unit monitor441, as shown inFIG. 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-describedprocedure room unit200.
• It is noted that implementations, employments, constructions, etc. of the first expression of the embodiment ofFIG. 59 are equally applicable to any one or more or all of the second through fourth expressions of the embodiment ofFIG. 59. In one example of one or more or all of the expressions of the embodiment ofFIG. 59, thepatient336 receiving thedrug328 is better controlled by having the occlusion pressure alarm setting change based on the variable commanded flow rate of thedrug328. 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.
• The following paragraphs present a detailed description of one particular enablement of the embodiment ofFIGS. 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 ofFIGS. 41-57. In this enablement, thePRU200 is the main interface between theSDS100 and the care team member responsible for administering drug(s). ThePRU200 is designed for use in the procedure room. ThePRU200 connects to theBMU300 by means of anUmbilical Cable160. ThePRU200 accepts input from all physiologic signals provided by means of theBMU300 as well as from theNasal Capnometer Module140 andOral Capnometer Module202 located within thePRU200. ThePRU200 accepts user-input parameters such as patient data, drug dose rate targets, and alarm trigger settings. ThePRU200 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.
• Dosage Controller (DC) is a drug delivery algorithm utilized by thePRU200 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.
• ThePRU200 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.
• ThePRU200 incorporates an intuitive display screen presentation that is called the PRU Graphical User Interface (PRU GUI)210. ThePRU GUI210 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. ThePRU GUI210 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 thePRU GUI210 is the PRUintelligent alarm box249 which allows the user to rapidly ascertain the patient's general condition by means of the colors Green, Yellow, and Red. The PRUintelligent alarm box249 utilizes algorithms to calculate and present a robust broadly defined status of the patient.
• Besides the DC, the monitoring shell, andPRU GUI210, thePRU200 incorporates other software-driven operations. These operations include monitoring functions and convenience functions. The convenience functions include an auto-prime that providesautomatic infusion line224 priming when thecassette251 anddrug vial250 have been installed intoPRU200. The monitoring functions include an infusion line priming interlock that allowsinfusion line224 priming when the T-site luer269 is attached to the T-site base271 of thecassette251. The monitoring functions also include oxygen delivery when connected to the patient and drug delivery when acassette251 is not recognized by the PRU as previously utilized in the PRU.
• ThePRU200 includes an uninterruptible power supply (UPS)214, aPRU console444, and aPRU monitor441. These items are stacked in the order described and typically reside upon anSDS cart101 or upon the user's own platform.
• TheUPS214 converts AC wall-outlet power to a low voltage power that provides all of the electrical energy utilized by thePRU console444. The primary portion of theUPS214 power that is fed to thePRU console444 is utilized by thePRU console444, while the remainder of the power is fed, via thePRU console444, to the PRU monitor441 and to theBMU300. TheUPS214 also has a rechargeable battery backup subsystem, which is utilized, as a temporary power source that is automatically invoked by theUPS214 when there is an outage of AC wall-outlet power otherwise provided via an AC power cord. TheUPS214 also provides thePRU console444 with an earth connection for electrical grounding. There is communications means between theUPS214 and thePRU console444 that conveys information regarding power status and battery status related features. The power, communications, and the earth connection are conveyed to thePRU console444 by means of a low voltage power cord, called theUPS output cable490, that is integral to theUPS214 whereby the UPSoutput cable connector491, located on the end of thisUPS output cable490, is plugged into thePRU console444.
• TheUPS214 includes an external AC power cord, universal AC/DC power module501, UPS powermanagement circuit board502, and UPSrechargeable battery pack503. TheUPS214 has an externally located UPS on/offswitch504, an UPSpower status indicator505 to display power status, and an UPSbattery status indicator506 to indicate battery charge status.
• UPS214 further includes coolingfans507 which are located to the rear ofUPS chassis508. A decorativefront bezel509 attaches toUPS chassis508 andUPS top cover473. UPStop E-PAC™ 474 andbottom E-PAC™ 475 are foam structures that function to secure all UPS internal components.
• TheUPS214 incorporates electrical circuitry that permits the UPSoutput cable connector491 to be detached from thePRU console444 while power is flowing while helping to prevent electrical contact sparking or undue electrical stress to the connector. The UPSoutput cable connector491 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.
• The PRU monitor441 provides the user with an interface to thePRU200 that combines a colorPRU monitor display442,PRU monitor touchscreen443 user interface, and PRU monitorspeakers458 and459. The PRU monitor441 is seated upon the top of thePRU console444. The PRU monitor441 is provided power and earth connection by thePRU console444. Video and audio signals are also provided by thePRU console444. The PRU monitor441 sendsPRU monitor touchscreen443 signals to thePRU console444.
• The PRU monitor441 is electrically attached to thePRU console444 by means of a PRU monitor cable that is plugged into the rear of thePRU console444. This cable provides the conveyance means for power, earth connection, video, audio, andPRU monitor touchscreen443 signals. The PRUmonitor cable connector463 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.
• ThePRU console444 is the central computational and process control resource of theSDS100. ThePRU console444 also contains specific functions including the drug infusion; patient CO2 gas analysis by means of capnometry; supplemental oxygen flow control; barcode reading ofcassette251, oral/nasal cannula145, anddrug vial250 barcode label(s) that is located upon the item or its packaging; patient data hardcopy printing; communications within theSDS100; communications to external resources; and power control/management.
• ThePRU console444 includes a PRUpower management board453,PRU processor board452, system I/O board451, barcodereader module assembly455,PRU printer454, IV (intravenous)pump module220,oxygen manifold206, control buttons and lighted indicators, external user connectors, andPRU console fan456. All of these items are enclosed within a single cabinet shroud. ThePRU processor board452 and the system I/O board451, which are linked together with a flexible circuit wire harness, are together referred to as thePRU host controller204.
• The PRUpower management board453 accepts theUPS214 power entering thePRU console444 and converts it to several lower voltage regulated outputs for use by thePRU200 and theBMU300. In one example these regulated outputs include 5V (volts), 12V, and 15V.
• ThePRU processor board452 provides the primary computation resource for theSDS100 and is one of the primary resources for signal input/output. The majority of theSDS100 software, including the DC and the monitoring shell, reside in non-volatile memory located on thePRU processor board452. ThePRU processor board452 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.
• A flexible circuit wire harness provides interconnection between about one hundred signal input/output lines of thePRU processor board452 and the system I/O board451. It includes a multi-dimensional flex print circuit board incorporating about ten connectors.
• The system I/O board451 is a multi-functional circuit board that integrates and processes signals from most circuits located within thePRU console444 including thePRU processor board452,IV pump module220,PRU printer454,barcode reader module455, and a diversity of operational circuits on the system I/O board451 itself. It also processes signals involving other sources outside thePRU console444 such as signals from theUPS214,BMU300, andPRU Monitor441.
• The system I/O board451 has circuitry resident upon the board itself. The system I/O board451 also contains modules that are mounted upon the board such as thenasal capnometer module140 andoral capnometer module202 and aflash memory module466.
• Numerous system I/O board451 functional circuits are described in the following paragraphs.
• Theflash memory module466 is detachable, user accessible, and provides for upgrades to theSDS100 internal memory in order to revise software for system operation.
• There is anasal capnometer module140 and anoral capnometer module202, which are mounted to and are a part of the system I/O board451. Thenasal capnometer module140 monitors the patient's combined nasal exhale. Theoral capnometer module202 monitors the patient's oral exhale. Eachcapnometer module140 and202 includes a suction pump control circuit that controls a suction pump, located independent from the system I/O board451, that draws in the patient sample in a controlled sample flow rate. Eachcapnometer module140 and202 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. Bothcapnometer modules140 and202 have their own software, which provides for automatic calibrations as needed, communications with thePRU host controller204, and other functions. There are a first and second capnometer I/O circuit that reside on the system I/O board451 and serve as the interface between therespective capnometer module140 and202 and thePRU processor board452. One function of this circuitry is to control power to thecapnometer module140 and202 electronics and the motors of capnometer pumps141 and142 in accordance withPRU processor board452 commands.
• The fast switch circuit resides on the system I/O board451 and provides for control of power that is applied to the PRU umbilical cableelectrical receptacle461. This circuit helps prevent sparking due to connect/disconnect of otherwise electrified receptacles and disconnects power toumbilical cable160 connector pins that may be exposed during disconnection.
• ThePRU state circuit510 works in conjunction with a similar state circuit, theBMU state circuit600 in theBMU300, whereby bothstate circuits510 and600 interact via theumbilical cable160 communication means. ThePRU state circuit510 in thePRU console444 provides the means for thePRU console444 to be aware of whether theumbilical cable160 is plugged into theBMU300 and whether theBMU300 is energized or off. This state status information is utilized by thePRU console444. For example, if thePRU200 is off and if theBMU300 is on, then theBMU300 is attached via theumbilical cable160 to thePRU200 and thePRU200 will automatically turn itself on. Another use for the state status is to preventumbilical cable160 communications alarms related to intentional disconnection of theumbilical cable160. Yet another role of the state status in thePRU200 is to help control when power is applied to the PRU umbilical cableelectrical receptacle461 in order to help avoid application of power to the exposed pins of an unpluggedumbilical cable160.
• An IV pump power control circuit controls power to theIV pump module220 in accordance with various commands from thePRU processor board452 and from interlocks such as the controller-monitoring module467 circuit. Also included in this circuit is astop drug button497 which forces shutdown of power to theIV pump module220 and also communicates the status of this button to thePRU processor board452. Also included in this circuit is apump door button496, which communicates the status of this button to thePRU processor board452 and also assists with the control of thedoor latch solenoid222 that unlocks thepump door201. Yet another function of this circuit is to convey the signal status of the IV pump motor encoder to thePRU processor board452.
• A PRU power button circuit monitors thepower button495, which communicates the status of this button to thePRU processor board452. The PRU power button circuit also includes an LED indicator driver circuitry that provides a ramping current to the LED indicator of the PRUpower status indicator498 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 PRUpower status indicator498 with a continuous current.
• A PRU printer circuit provides electrically isolated controlled power for thePRU printer454 and also provides electrically isolated communications between thePRU processor board452 and thePRU printer454. A barcode reader circuit provides controlled power for thebarcode reader module455 and also provides a communications interface for thebarcode reader module455 to thePRU processor board452. A PRU fan control circuit controls power to thePRU console fan456. This circuit is able to detect a slow running or stalledPRU console fan456 and then issue an alert to thePRU processor board452.
• A PRU temperature sensor circuit incorporates a thermal sensor and signal processing that monitors the internal temperature of thePRU console444 and presents that temperature data to thePRU processor board452. This thermal sensor, along with associated support circuitry, is located on the system I/O board451 where it can effectively monitor the thermal status inside thePRU Console444.
• The controller-monitoring module467 is a monitor circuit that monitors the viability of thePRU host controller204 and associated software programs it is running. If the controller-monitoring module467 detects undesiredPRU host controller204 function (including in terms of too frequent or infrequent processor activity), the controller-monitoring module467 will notify the PRU processor board of this condition and the controller-monitoring module467 will take direct action to disable theIV pump module220 and shut down most functions within a short period of time. In the event of a controller-monitoring module467 detectable event, the controller-monitoring module467 will also temporarily sound a buzzer that is located on the PRU system I/O board451, as a means to notify the user of the undesired condition.
• A PRU monitor control circuit controls power to the PRU monitor441. It is controlled by thePRU processor board452 and the circuit includes a current limiting function. A PRU audio amplifier circuit includes two audio amplifier circuits that accept low level audio from thePRU processor board452 and amplify these signals. These amplified signals are utilized to drive the two PRU monitorspeakers458 and459 in the PRU monitor441. The monitor control circuit includes conveyance of a PRU monitor speaker interlock signal to thePRU processor board452 which helps assure that theSDS100 only operates if the PRU monitorspeakers458 and459 are connected to thePRU console444.
• A modem circuit provides a means for theSDS100 to communicate with non-SDS devices via a telephone line. This circuit implements isolated circuitry. An Ethernet circuit provides a means for theSDS100 to communicate with non-SDS devices via an Ethernet line. This circuit also implements isolated circuitry.
• PRU UPS communications interface is a circuit that provides the interface between the UPS communications lines and thePRU processor board452.
• A supplemental oxygen control circuit provides the basic signal processing interface between thePRU processor board452 and supplemental oxygen related sensors. The sensors include theoxygen sensor482, 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 board451 in the vicinity of this circuit, while the other listed sensors are located on theoxygen manifold206. The supplemental oxygen control circuit also provides power signals that drive the variable-size-orifice (VSO) flow restrictor480 (such as a VSO solenoid), which regulates supplemental oxygen flow. Included features are electrical control of theVSO flow restrictor480 and the signal processing interface between thePRU processor board452 and theVSO flow restrictor480. Yet another role of the supplemental oxygen control circuit is to control the oxygen sampling solenoid in accordance with commands received from thePRU processor board452.
• The last-to-be-discussed system I/O board451 functional circuit is the voltage monitoring circuit. The voltage monitoring circuit provides an interface between thePRU processor board452 and the various power supply voltages resident on the system I/O board451 in order to monitor those voltages and determine if they are in desired ranges.
• There is anasal capnometer pump141, located within thePRU console444, which is plumbed, but not physically affixed, to thenasal capnometry module140. There is anoral capnometer pump142, located within thePRU console444 which is plumbed, but not physically affixed, to theoral capnometry module202.
• Thebarcode reader assembly455 incorporates a self-containedbarcode reader module464 that is mounted on a metal frame that includes a mirror. The metal frame is mounted inside the housing ofPRU console444 in an orientation that allows the projection of the barcode laser beam through an open window of the housing of thePRU console444 to shine upon an area external to thePRU console444. The user places the barcode of the packaging containing the oral/nasal cannula145 orcassette251 ordrug vial250 within reading range of the activebarcode reader module464 laser beam. Thebarcode reader module464 then reads the barcode.
• ThePRU printer454 includes a thermal print head, a paper feed mechanism, a printer driver board, and aPRU printer door460. This assembly is mounted to the housing of thePRU console444 utilizing electrically isolated means that helps provide for an electrically isolated access to the printer paper roll.
• TheIV pump module220 provides the drug pumping function of thePRU console444. TheIV pump module220 accepts thedisposable cassette251. TheIV pump module220 propels metered drug(s) through thecassette251 via peristaltic massage of theflexible tube277. TheIV pump module220 detects the presence of the T-sitecommercial luer269 placement into the respective receptacle ofcassette251 and also detectsdrug vial250 seating upon the respective receptacle of thecassette251. TheIV pump module220 incorporates several features such as detection of air-in-line and occlusion of the downstream fluid path. Another function of theIV pump module220 is thepump door201 and the controlled opening of thepump door201.
• TheIV pump module220 includes anIV pump housing239 that has attached to it thepump door201, thepump door latch205 and the pumpdoor lifting mechanism207,IV pump assembly232, IVpump control board233, an optical sensor board, and air-in-line sensor225. TheIV pump assembly232 includes an IV pump motor, a pump finger mechanism, an IV pump motor encoder, downstreamIV pressure sensor223, and an IV pump sensor board. The optical sensor board227 has the T-site sensor226 and thevial sensor228. These two sensors protrude through theIV pump housing239 in the vicinity of thepump cassette deck221 where they interact with the associated mechanisms of the seateddisposable cassette251. The optical sensor board also has adoor latch solenoid222 that, when activated, presses upon thepump door latch205 to release thepump door201, whereby thepump door210 is lifted by pumpdoor lifting mechanism207 and proceeds to the open position to expose thecassette deck221 and permit the user access for installation or removal of thecassette251.
• Theoxygen manifold206 is the primary component of the supplemental oxygen delivery subsystem of thePRU console444. Theoxygen manifold206 provides a path for oxygen flow, oxygen flow control, oxygen purity evaluation, and oxygen overpressure relief. It is mounted at the rear section of thePRU console444.
• Theoxygen manifold206 includes a manifold that is equipped with the following items that are encountered by incoming oxygen gas in the order listed: externally locatedoxygen input coupler484, high sidepressure relief valve485 and associated exhaust port, highside pressure sensor487,oxygen diverter492, fixedrestrictor489,VSO flow restrictor480, lowside pressure sensor488, low sidepressure relief valve486, and oxygen main output outlet. Ancillary gas paths include anoxygen sample solenoid481,oxygen sensor482, and oxygensensor exhaust port483. There are also outlets for plumbing gas pressure from each side of the fixedrestrictor489 to thedifferential pressure sensor479 which is located on the system I/O board451. Theoxygen manifold206 has anoxygen input coupler484 that protrudes from the rear of thePRU console444 for user connection to an external supply of supplemental oxygen.
• Theoxygen manifold206 has a flow path that intercepts an oxygen sample. The oxygen sample is gated by anoxygen sample solenoid481 to temporarily allow flow of supplemental oxygen past the attachedoxygen sensor482. Theoxygen manifold206 has an oxygensensor exhaust port483 that permits the sampled gas to be expelled from theoxygen manifold206.
• Theoxygen manifold206 utilizes a high sidepressure relief valve485 that protects the oxygen high pressure path from excessive high supply pressure by relieving that pressure via the exhaust port of the high sidepressure relief valve485. Theoxygen manifold206 utilizes a low sidepressure relief valve486 that protects the oxygen low pressure path from excessive output pressure by relieving any excessive pressure via the exhaust port of the low sidepressure relief valve486.
• Theoxygen diverter492 is a manually operated valve and is operated via an externally accessibleoxygen diverter knob493. Thisoxygen diverter492 can be set to the normal position whereby the supplemental oxygen flow is only directed through the regulated flow path of theSDS100 system. Theoxygen diverter492 can alternately be set to the SDS-system-bypass position, whereby the supplemental oxygen flow no longer flows through the regulated flow path of theSDS100 system. Instead, it flows exclusively directly to an externally accessiblebarbed oxygen outlet494 that provides the user with a convenient means to connect a user-provided SDS-system-bypass oxygen delivery device.
• ThePRU console444 provides a direct means for user input via thePRU power button495, thestop drug button497, and thepump door button496. ThePRU power button495 allows thePRU200 to be placed into standby or ready mode. Thestop drug button497 allows the user to halt drug(s) delivery by cutting off power to theIV pump module220. Thepump door button496 allows the user to open thepump door201 when there is nocassette251 installed in theIV pump module220 or when thecassette251 is present and the T-Sitecommercial luer269 is installed into thecassette251.
• ThePRU console444 provides the user with status indications by means of two illuminated indicators. One of these indicators is the PRUpower status indicator498, which is integral to thePRU power button495. 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 lockedindicator499 which is integral to thepump door button496, which is lit when thepump door201 is locked, and which is not lit when thepump door201 is not locked.
• ThePRU console444 has several externally user accessible connectors. The PRU umbilical cableelectrical receptacle461, located on the front panel of thePRU console444, is a connector for providing convenient electrical connections toumbilical cable160. It utilizes various pin heights to provide hot switching without degradation of pins. The PRU umbilical cablepneumatic receptacle462, located on the front panel of thePRU console444, is a connector for providing convenient simultaneous multiple pneumatic connections toumbilical cable160 including pneumatic paths for oxygen delivery and patient exhale samples. Themodem connector470, located on the rear panel of thePRU console444, is a type RJ11 connector for providing user connection to an external telephone line. TheEthernet connector471, located on the rear panel of thePRU console444, is a type RJ45 connector for providing user connection to an external Ethernet line. ThePRU power connector465, located on the rear panel of thePRU console444, is a connector for providing user connection ofPRU console444 to UPSoutput cable connector491.
• ThePRU console444 has a fan referred to as thePRU console fan456. ThePRU console fan456 provides thermal cooling of the components located inside thePRU console444. ThePRU console fan456 also provides for robust ventilation of thePRU console444 as a means to dilute any potentially present supplemental oxygen entering thePRU console444 thereby helping keep the oxygen concentration within a desired range.
• The internal components ofPRU200 are sandwiched between topPRU foam support447 and bottomPRU foam support448. In one example, PRU foam supports447 and448 are constructed of rigid foam well known in the electronics industry as an E-PAC™ chassis. Strategically located recesses and cavities in the E-PAC™ chassis efficiently capture and securely hold pc boards, pumps, LCD, speaker and other components. The outer housing ofPRU200 is constructed of rigid molded thermoplastic (e.g. ABS) and includestop chassis445,top bezel446 andfront bezel450.Bottom chassis449 is constructed of sheet metal and forms part of the outer housing ofPRU200. The housing components are held together with molded-in snap features and screws:Top chassis445 is designed to be readily removable for access to thePRU200.
• PRU/BMU Interface
• 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 system100 (or other type of medical-effector system100′), an embodiment of which is shown inFIGS. 41-57 and60-62. An expression of the embodiment ofFIGS. 41-57 and60-62 is for a sedation delivery system100 (or other type of medical-effector system100′) including a microprocessor-based bedside monitoring unit300 (an embodiment of which is shown inFIGS. 41 and 60-62), a microprocessor-based procedure room unit200 (an embodiment of which is shown inFIGS. 41-57), and an umbilical cable160 (an embodiment of which is shown inFIGS. 41, 42,60 and61). Thebedside monitoring unit300 has a bedside-monitoring-unit host controller301, 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. Theprocedure room unit200 has a drug-deliveryflow control assembly220′ (or other type ofmedical effector220″) and has a procedure-room-unit host controller204. The procedure-room-unit host controller204 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-deliveryflow control assembly220′ (or othermedical effector220″) based at least in part on the program inputs. Theumbilical cable160 has a first end attached or attachable to the second series of connection points of thebedside monitoring unit300 and has a second end attached or attachable to theprocedure room unit200. At least one of the first and second ends is detachable from the correspondingbedside monitoring unit300 or theprocedure room unit200. The procedure-room-unit host controller204 and the bedside-monitoring-unit host controller301 are operatively connected together when theumbilical cable160 is attached to theprocedure room unit200 and thebedside monitoring unit300.
• In one arrangement of the expression of the embodiment ofFIGS. 41-57 and60-62, the drug-deliveryflow control assembly220′ includes a drug-deliveryinfusion pump assembly220 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.
• In one example of the expression of the embodiment ofFIGS. 41-57 and60-62, theprocedure room unit200 has an individual procedure-room-unit (PRU) identifier and thebedside monitoring unit300 has an individual bedside-monitoring-unit (BMU) identifier. The procedure-room-unit host controller204 of the procedure-room unit200 compiles an electronic history of thebedside monitoring unit300 when attached to theprocedure room unit200 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, thesedation delivery system100 also includes a single-patient-use drug-delivery cassette assembly251 and a single-patient-use cannula assembly145 and a single-patient-use drug vial250. The drug-delivery cassette assembly251 has an individual cassette identifier and is operatively connectable to the drug-deliveryflow control assembly220′ of theprocedure room unit200. Thecannula assembly145 has an individual cannula identifier and is attachable to thebedside monitoring unit300. The drug vial has an individual vial identifier and is operatively connectable to the drug-delivery cassette assembly251. The procedure-room-unit host controller204 of the procedure-room unit200 compiles an electronic history of the drug-delivery cassette assembly251 and thecannula assembly145 anddrug vial250 based on the individual cassette and cannula and vial identifiers (the SPU identifiers).
• In a further expression of the embodiment ofFIGS. 41-57 and60-62, theprocedure room unit200 downloads has an individual procedure-room-unit (PRU) identifier and thebedside monitoring unit300 has an individual bedside-monitoring-unit (BMU) identifier. The procedure-room-unit host controller204 of the procedure-room unit200 compiles an electronic history of thebedside monitoring unit300 when attached to theprocedure room unit200 based on the individual BMU identifier.
• In a further expression of the embodiment ofFIGS. 1-57 and60-62, thedrug cassette assembly251 individual cassette identifier is a unique barcode of a sterile package containing thedrug cassette assembly251 and/or a barcode on thedrug cassette assembly251. Thecannula assembly145 individual cannula assembly identifier is a unique barcode of a sterile package containing thecannula assembly145 and/or a barcode on thecannula assembly145. Thedrug vial250 individual vial identifier is a unique barcode of a sterile package containing thedrug vial250 and/or a barcode on thedrug vial250. The unique identifiers are read atPRU200 usingbarcode reader455.
• In one enablement of the expression of the embodiment ofFIGS. 41-57 and60-62, when thebedside monitoring unit300 is attached to theprocedure room unit200, the electronic history of the cassette, cannula and vial identifiers is passed on toBMU300. TheBMU300 updates its electronic history of SPU identifiers so previously used SPUs cannot be used again with that particular BMU. In a further enablement, theBMU300 also copies its history of SPU identifiers toPRU200. 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.
• In one enablement of the expression of the embodiment ofFIGS. 41-57 and60-62, when thebedside monitoring unit300 is attached to theprocedure room unit200, the bedside-monitoring-unit host controller301 of a turned-onbedside monitoring unit300 turns on a turned-offprocedure room unit200. In the same or a different enablement, when thebedside monitoring unit300 is attached to theprocedure room unit200, the procedure-room-unit host controller204 of a turned-onprocedure room unit200 turns on a turned-offbedside monitoring unit300. In one variation, when aPRU200 or aBMU300 is turned on, itshost controller204 and301 boots up.
• In one illustration of the expression of the embodiment ofFIGS. 41-57 and60-62, thebedside monitoring unit300 displays patient monitoring while not attached to theprocedure room unit200 and displays patient monitoring while attached to theprocedure room unit200 when the procedure-room-unit host controller204 detects certain faults in theprocedure room unit200. In the same or a different illustration, the procedure-room-unit host controller204 shuts off the drug-deliveryinfusion pump assembly220 when certain faults are detected in an attachedbedside monitoring unit300 and/or in theprocedure room unit200.
• In one implementation of the expression of the embodiment ofFIGS. 41-57 and60-62, theumbilical cable160 includes a power feed line, and the procedure-room-unit host controller204 shuts off power to the power feed line of theumbilical cable160 when theumbilical cable160 is disconnected from thebedside monitoring unit300 and/or theumbilical cable160 is disconnected from theprocedure room unit200. In one variation, thebedside monitoring unit300 includes a bedside-monitoring-unit battery303, and power from theprocedure room unit200 charges the bedside-monitoring-unit battery303 via the power feed line of theumbilical cable160.
• Bedside Monitoring Unit
• 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 inFIGS. 6, 41 and60-62. A first expression of the embodiment ofFIGS. 6, 41 and60-62 is for a stand-alone patient monitoring device including a oral/nasal cannula145, a first series of connection points from receiving input signals from patient monitoring connections and a connector151 for receiving a supplemental O₂supply152.
• A second expression of the embodiment ofFIGS. 6, 41,60-62 is for aBMU300 that accepts user inputs of patient and procedure data including agraphic user interface212. In this application,BMU300 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.
• A third expression of the embodiment ofFIGS. 6, 41,60-62 is for aBMU300 that provides for the delivery of audible commands topatient10 including aARM module340, an audible output through oral/nasal cannula145 andearpiece135vibratory handset342 andinput cable150.
• In one implementation of the third expression, during a pre-procedure set-upBMU300 provides an audible command topatient10 viaear piece135, such as “squeeze left hand” and monitors the response time to establish a baseline response rate. In one illustration of theimplementation cannula145 provides for the delivery of audible commands to a patient10 requesting a response for an Automated Responsiveness Monitor (ARM)340.
• A fourth expression of the embodiment ofFIGS. 6, 41,60-62 is for aBMU300 in combination with a procedure room unit including a oral/nasal cannula145, 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 expressionumbilical cable160 connects to BMU umbilical cable connector151 (in lieu of connection to supplemental O₂supply152) and communicates patient parameters fromBMU300 toPRU200. In oneillustration BMU300 travels withpatient10 to a procedure area.Umbilical cable160 connects BMU toPRU210 andBMU300 downloads all patient input data and parameters (inclusive of physiological parameters and CO₂readings) toPRU210.PRU210 initiates O₂delivery to the patient (as required) viacable160.
• In a fifth expression of the embodiment ofFIGS. 6, 41, and60-62,BMU300 monitors user inputs of patient parameters and includes patient information ongraphic user interface212 during post-procedure recovery. In this application,BMU300 may be used for displaying patient parameters (such as physiological parameters) during a post-procedure recovery, providing an O₂supply, if required and allowing medical personnel to assess the condition ofpatient10 prior to release. In one implementation of the fifth expression,BMU300 includes alight bar208 of multiple LEDs for easy viewing by medical personnel.Light bar208 is able to convey patient condition in different formats, such as green lighting, red lighting and yellow lighting, blinking lights and steady state lights.
• In a second implementation of the fifth expression,BMU300 utilizesARM module340 andARM handset342 to automatically query the patient and record time-based responsiveness replies and combine the responses with other monitored parameters to conduct patient assessment.
• The following paragraphs present a detailed description of one particular enablement of the embodiment ofFIGS. 6, 41 and60-62. 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 ofFIGS. 6, 41 and60-62. In thisenablement BMU300 provides for monitoring of patient physiologic parameters during all phases of a procedure. WhenBMU300 is connected to PRU200 viaumbilical cable160 in the procedure room, the physiologic parameters monitored byBMU300 are displayed onPRU200.BMU300 containsBMU host controller301, which is the computer for the unit.BMU host controller301 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.BMU300 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.
• BMU300 contains electrocardiogram (ECG)module330, which contains electronics, and software used to process patient signals as supplied throughECG pads332 and ECG leads334.ECG pads332 and ECG leads334 are well known in the medical. One example ofECG module330 is available from Mortara Instrument, Inc., Milwaukee, Wis., Model M12A. The resultant data from this module are then sent toBMU host controller301 for display of patient physiologic parameters (heart rate and wave form).
• BMU300 also contains non-invasive blood pressure (NIBP)module320.NIBP module320 includesNIBP pump322. One example ofNIBP module320 is available from SunTech Medical Instruments, Inc., Morrisville, N.C., Model MC2619045. Non-invasive blood pressure (NIBP)module320 contains the electronic components, software, pump, and valves used to inflate non-invasive blood pressure (NIBP)cuff321. NIBP cuffs are well known in the medical arts. The electronic components process the information received throughNIBP cuff321 with software. The resultant blood pressure data (systolic, diastolic pressures) are then sent toBMU host controller301.
• Pulse oximeter (SpO₂)module310 is also contained withinBMU300. One example ofpulse oximeter module310 is available from Dolphin Medical, Inc., Hawthorne, Calif., Model OEM701.Pulse oximeter module310 contains the electronic components and software used to process patient information received through reusablepulse oximeter probe311. One example ofpulse oximeter probe311 is available from Dolphin Medical, Inc., Hawthorne, Calif.,Model 210. The resultant data (pulse rate, SpO₂, and wave form) are sent toBMU host controller301.
• Also located withinBMU300 is automated responsiveness monitor (ARM)module340.Arm module340 includesARM speaker assembly341. During a procedure,ARM module340, which includes hardware and software, provides simultaneous audible and tactile stimuli viaearpiece135 and avibratory ARM handset342 to the patient.Arm handset342 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 squeezingARM handset342 which activates a mechanical switch within the handset and sends a signal toARM module340. The ARM audible stimulus is a request (“please squeeze your hand”) and a mild vibration ofARM handset342. 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!”) andARM handset342 vibration intensity is increased a third and final time. If the patient fails to squeezeARM handset342 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.
• Oral/nasal cannula145 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 cannula145 connects toBMU300 viacannula connector plate304.Cannula connector plate304 fluidly connects outputs from oral/nasal cannula145 withBMU300.Cannula connector plate304 also connects outputs fromBMU300 with oral/nasal cannula145. WithinBMU300 is located a pressure transducer (which, in one example, is a nasal pressure transducer47) which functions to detect when the patient is inhaling or exhaling and communicates to PRU200 to control oxygen flow. Oral/nasal cannula145 also includesearpiece135, which delivers audible respond commands to the patient fromARM module340.
• Apower button318 is located on the face ofBMU300, illuminates green whenBMU300 power is on, and pulses green whenBMU300 is in standby mode.BMU300 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.Speaker216, for providing audible indicators to the user, is located on the face ofBMU300. Alight bar208 is located on the top portion ofBMU300, is molded from a semi-transparent thermoplastic (e.g., polycarbonate), and is illuminated by LED's203 to provide visual indication of alarm conditions. Thelight bar208 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 bar208 may, for example, display or flash green when theBMU300 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 bar208 may change color, intensity and flashing cycle to portray ventilation magnitude and/or status.Light bar208 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.
• A separate thermal printer may be used to create a hard copy record of sedation information.Printer port218 is provided on the side ofBMU300 for connection of a remote printer.BMU300 can operate on either internal battery power by utilizingBMU batteries303 or through an external a/c power adaptor. Further,BMU300 receives power fromPRU200 when they are connected in the procedure room. Anoxygen adaptor152 and tubing set can be connected betweenBMU300 and a standard oxygen wall outlet or oxygen tank to allow oxygen to be conveniently provided to a patient throughBMU300 whenBMU300 is not connected through umbilical160 to PRU200 (typically pre-procedure and recovery).
• As best illustrated inFIG. 62, the internal components ofBMU300 are sandwiched betweentop foam support312 andbottom foam support313. In one example, foam supports312 and313 are constructed of rigid foam well known in the electronics industry as an E-PAC™ chassis. Strategically located recesses and cavities in the E-PAC™ chassis efficiently capture and securely hold pc boards, pump, LCD, speaker, and other components. The outer housing ofBMU300 is constructed of rigid molded thermoplastic (e.g., ABS) and includes bottom314,front315, back316, and top317. The housing components are held together with molded-in snap features and screws.Housing top317 is designed to be readily removable for access tobatteries303.
• Sedation Delivery System
• Referring toFIGS. 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.SDS100 uses a drug delivery algorithm called Dosage Controller (DC) and anintravenous infusion pump220 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.
• SDS100 includes four routine physiologic monitors. These are apulse oximeter110 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 acapnometer140 and202 for measuring the patient's respiratory activity. In addition,SDS100 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 interface212; 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.
• SDS100 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.BMU300 is connected to the patient in the pre-procedure room and stays with the patient through recovery.BMU300 containspulse oximeter module310,NIBP module320,ECG module330, andARM module340. 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 throughBMU300 and oral/nasal cannula145. When the patient is wheeled into the procedure room,BMU300 is attached to PRU200 byumbilical cable160, which contains both pneumatic and electrical lines. During the procedure,umbilical cable160 allowsPRU200 to receive patient physiologic data fromBMU300 as well as the patient's respiratory gases. In addition,umbilical cable160 allows for delivery of oxygen to the patient fromPRU200.
• PRU200 adds capnography to the system, monitoring and displaying the patient's respiration rate and end-tidal CO₂. ARM monitoring is activated and the patient's responsiveness is displayed to the care team. As soon asPRU200 detects respiration activity (from the capnometer), mandatory oxygen delivery is initiated. All drug delivery is performed byPRU200 as it containsintravenous infusion pump220, 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.PRU200 is the main interface between the care team member responsible for administering sedation andSDS100. It containsGUI210 that displays the status of the patient and facilitates adjustment of the patient's level of sedation.
• Referring now toFIGS. 42 and 43,PRU200 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.PRU200 is designed to stay in the procedure room and is the mechanism for drug delivery.
• WithinPRU200 are located twocapnometers140 and202 used for sampling CO₂from 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, EtCO₂, and respiration wave form) are sent toPRU host controller204.
• Sedation Delivery System100 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 byARM system340. 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 System100 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 withSedation Delivery System100 to monitor a patient's brain activity.Sedation Delivery System100 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 System100 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.
• Referring toFIGS. 42 through 47,Infusion pump220 is located in the front portion ofPRU200 and provides for the delivery of drug(s).Disposable cassette251 interfaces withpump220.Cassette251 holds adrug vial250 from which drug(s) is delivered to the patient.Cassette251 includes a base plate holdingvial spike261,infusion tubing277 &259, and t-site luer connector269 located at the patient end of the infusion tubing. As illustrated inFIG. 44,pump door201 onPRU200 opens to acceptcassette251 and securescassette251 into proper position withpump220 when closed. T-site sensor226 is an optical type sensor located inPump220 that is used to signalPRU host controller204 of the presence of T-site269 whencassette251 is installed. Another optical type sensor located inpump220 isvial sensor228. It is used to signalPRU host controller204 of the presence of adrug vial250. Air-in-line sensor225 is an ultrasonic device that straddles a short segment oftubing277 and detects the presence of air or air bubbles being pumped throughtubing277 from the drug vial.Occlusion detector223, located inpump220, is a small pressure transducer that rests againsttubing277 to detect an increase in the tubing internal pressure indicating a possible occlusion ininfusion tubing259. Pumpfingers229 interface with a segment oftube277 located across the top ofcassette251 and their peristaltic pumping action pumps drug(s) from thedrug vial250 throughtubes277 &259 and to the patient.Pump220 is driven by software on electronic circuit boards that interface withPRU host controller204.
• FIG. 45 further illustrates the proper location ofcassette251 inpump220 and shows pumpdoor201 open.FIG. 46 illustratescassette251 inpump220,door201 closed, and adrug vial250 in position to be placed onvial spike261.FIG. 47 illustratescassette251 inserted intopump220,door201 closed, and adrug vial250 placed onvial spike261.
• Referring again toFIGS. 42 and 43, located withinPRU200 isoxygen delivery module206, which controls the delivery of oxygen to the patient during the procedure.Oxygen delivery module206 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 intoPRU200, 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.
• PRU graphic user interface (GUI)210 allowsPRU200 to relay information gathered from the physiologic monitors and sensors to the user and allows the user to enter information and commands. PRUgraphic user interface210 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 (SpO₂) 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,SDS100 incorporates distinct audible tones for different alarm levels (i.e., yellow or red).
• PRU200 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 withinSDS100.UPS214 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.
• PRU200 includesPRU host controller204 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, andinfusion pump220.
• Operating software controls the interaction and function ofSDS100. 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).
• As a user convenience,SDS100 contains software to automatically prime thepatient infusion line224 when a valid drug delivery cassette and drug vial is loaded intoinfusion pump220. As a monitoring feature, withcassette251 installed intoinfusion pump220, a sensor detects the presence of the t-site connector installed ondrug delivery cassette251. The SDS primes theinfusion line224 when the t-site is detected as being attached to the drug delivery cassette.
• The following paragraphs present particular examples ofseveral SDS100 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.
• 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 thePRU GUI210. The oxygen is delivered to the patient by means of the oral/nasal cannula145, which includes a specialized mask-like portion that is affixed to the oral/nasal zone of the patient's face.
• The oxygen flow is controlled within thePRU console444 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 theumbilical cable160 to theBMU300. TheBMU300 presents the oxygen to a single-use disposable called the oral/nasal cannula145 that is attached to theBMU300. The oral/nasal cannula145 conveys the oxygen to the patient, via itsoxygen tube353, and dispenses the oxygen to the patient's nasal and oral zones via twonasal oxygen prongs422 and oneoral prong369.
• The oxygen delivery functional subsystem has several ancillary oxygen related functions, which are primarily resident within thePRU console444. 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, thePRU console444 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 cableconnector end A161 or umbilical pneumatic cableconnector end B162 at either thePRU console444 or at theBMU300 or the disconnection of the oral/nasal cannula145 from theBMU300. When the oral/nasal cannula145 is disconnected from theBMU300, the oxygen is not delivered to the intended patient site. This disconnection is detected byPRU console444's observation of the unexpected pressure level measured in the oxygen delivery path. When detachment is discerned, the oxygen delivery is automatically ceased by thePRU console444 until the detachment is resolved by the user. Another ancillary oxygen function is the hand-operated oxygen gas valve called theoxygen diverter492 at the rear of thePRU console444. Theoxygen diverter492 permits the user to conveniently manually divert the incoming supplemental oxygen away from thePRU Console444 interior and instead present that oxygen supply to an SDS-system-bypass oxygen source fitting referred to as thebarbed oxygen outlet494. Thebarbed oxygen outlet494 permits the user to access oxygen via theSDS100 for use with alternate oxygen care equipment, such as would be utilized to bypass the SDS system.
• Theoxygen manifold206, located in thePRU console444, 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 theoxygen manifold206 or are not mounted to theoxygen manifold206 but are plumbed to theoxygen manifold206. The supplemental oxygen is attached by the user to a coupling on theoxygen manifold206 referred to as theoxygen input coupler484, which is located at the rear of thePRU console444. This incoming oxygen has its pressure measured by a highside pressure sensor487, located on theoxygen manifold206 that monitors the high side pressure and presents that data to thePRU host controller204. This incoming oxygen is also presented to a high sidepressure relief valve485, located on theoxygen manifold206, which will exhaust excessive pressure to the ambient atmosphere. This incoming oxygen is also presented to anoxygen sample solenoid481 that is normally closed except during sampling. Whenever thePRU console444 checks the incoming oxygen for possible hypoxic content, theoxygen sample solenoid481 is momentarily opened. This presents a stream of incoming oxygen that is blown down an ancillary gas path past theoxygen sensor482 and subsequently exhausted out of theoxygen manifold206 to the ambient atmosphere. ThePRU host controller204 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 thePRU console444 is deemed non-hypoxic and is permitted to be utilized by theSDS100.
• The incoming oxygen primary gas path continues into theoxygen diverter492. Theoxygen diverter492 normally allows the oxygen to pass through along the primary gas path. However, if theoxygen diverter knob493 is in the SDS-system-bypass position, the oxygen is instead directed away from the primary gas path and rather is directed into an oxygenexternal output orifice478 that serves as a flow restrictor. Then the oxygen goes to an external nozzle referred to as thebarbed oxygen outlet494. The primary oxygen path proceeds to the fixedrestrictor489, 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 fixedrestrictor489. The differential pressure, as seen on each side of the fixedrestrictor489, 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 adifferential pressure sensor479 that is located on the system input/output (I/O) board. Thedifferential pressure transducer479 provides the oxygen pressure data to thePRU host controller204. ThePRU host controller204 determines the implied oxygen flow rate through the fixed restrictor by means of mathematical formulae and tabulated correlation data.
• The oxygen proceeds past the fixedrestrictor489 and proceeds into a voltage sensitive orifice (VSO) solenoid, referred to asVSO Solenoid480, which has an orifice size that is proportional to the voltage applied to its actuator coil. The VSO variable gas flow restriction provides for thePRU console444 control of the oxygen gas flow rate, including the complete shut-off of oxygen flow when appropriate. TheVSO solenoid480 is operated by thePRU host controller204 in accordance with the oxygen control algorithm, utilizing a hardware/software feedback loop that includes thedifferential pressure sensor479. The output of theVSO solenoid480 is presented to a lowside pressure sensor488 that monitors the low side pressure and presents that data to thePRU host controller204.
• The primary gas path continues past a low sidepressure relief valve486 which will exhaust excessive pressure to the ambient atmosphere. The oxygen exits theoxygen manifold206 at a fitting, which has flexible tubing, connected to it. This flexible tubing conveys the flow-controlled oxygen over to the PRU umbilical cablepneumatic receptacle462 located at the front of thePRU console444. One of the channels of the PRU umbilicalpneumatic receptacle462 is dedicated for oxygen delivery. Theumbilical cable160 is attached by the user to the PRU umbilicalpneumatic receptacle462. The controlled flow oxygen is transported along theumbilical cable160 via a dedicated oxygen tubing line within theumbilical cable160 where it is delivered at the other end of theumbilical cable160 into theBMU300.
• 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.
• 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.
• 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.
• 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.
• 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 thePRU console444 via the BMU umbilical electrical connector and associated umbilical cable.
• 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 thePRU console444.
• 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 thenasal capnometer pump141 which is located in the E-PAC™ chassis within thePRU console444. Thenasal capnometer pump141 provides the vacuum that is propelling the sample from the cannula into thePRU console444. Thenasal capnometer pump141 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 thenasal capnometer pump141 and then passes through tubing to an exit port located within thePRU console444 where that gas is diluted with thePRU console444 enclosure air that is being circulated by the PRU console fan.
• 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 (IR) sensor, control electronics, pressure sensor, and pneumatic reservoir. The exhale sample exits the oral capnometer module and travels via tubing to theoral capnometer pump142 which is located in the E-PAC™ chassis within thePRU console444. Theoral capnometer pump142 provides the vacuum that is propelling the sample from the cannula into thePRU console444. Theoral capnometer pump142 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 theoral capnometer pump142 and then passes through tubing to an exit port located within thePRU console444 where that gas is diluted with thePRU console444 enclosure air that is being circulated by the PRU console fan.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• The drug delivery functional subsystem provides a means for controlled delivery of drug(s) from thedrug vial250 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• The following paragraphs present a description of one particular exemplary use ofSDS100 without limiting the scope of the invention. As shown inFIGS. 77-80, components ofSDS100 are employed throughout a surgical procedure, including pre-procedure set-up and post-procedure recovery. The patient arrives in the pre-procedure room,step1200. A nurse or technician mountsBMU300 to either the bedrail or IV pole,step1201.BMU300 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. OnceBMU300 is in place, the nurse or clinician may connectNIBP cuff120 andpulse oximeter probe110 to the patient,step1202. These connections are made between the patient andBMU300.BMU300 will automatically begin monitoring parameters such as, for example, diastolic and systolic blood pressure, mean arterial pressure, pulse rate, oxygenation plethysmogram, and oximetry value,steps1203 and1204. The readings taken byBMU300 will be displayed for the nurse or technician onBMU GUI212. 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,step1206. 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,step1206, the nurse or technician may start the peripheral IV by placing a catheter in the patient's arm,step1207. 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 attachECG pads130,ARM handset342,ARM earpiece362 and oralnasal cannula351 to the patient,step1208.
• Once the patient is connected to the above-mentioned items, the nurse or technician may explainARM system340 to the patient. This explanation may involve the nurse or technician instructing the patient to respond to auditory stimulation fromearpiece362 and/or tactile stimulation fromARM handset342 by squeezingARM handset342. 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,step1209. Automated ARM training is a program run byBMU300 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.BMU300 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,step1210; if the patient fails to complete the training a nurse or other clinician must intervene and determine if the patient may continue, step1210-A. If the clinician decides the user may proceed, then the patient will proceed to step1211; if the clinician decides the patient is unable to continue, then the procedure will be canceled,step1213. 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.
• In addition to successfully completing automated ARM training, the patients parameters must be in an acceptable range,step1205. The clinician may decide upon what an acceptable range is by inputting this information intoBMU300 by means ofBMU GUI212. 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, step1205-A. If the clinician decides the patient is able to continue, the patient will proceed to step1211, if the clinician decides the patient is unable to continue, then the procedure will be cancelled,step1213. Just prior to leaving the pre-procedure room for the procedure room, the nurse administers a predetermined low dose of an analgesic drug,step1211 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,step1212.
• The patient andBMU300 relocate to the procedure room,step1220 and are received by the physician (non-anesthesiologist) and procedure nurse.BMU300 may be connected toPRU200 viaumbilical cable160 upon the patient entering the procedure room,step1221. Upon connection, the NIBP, pulse and oximetry history from the patient will automatically up-load to PRU200 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 ofBMU300 toPRU200, theBMU GUI212 changes from a monitoring screen to a remote entry screen forPRU200. Display information fromBMU300 is automatically transferred toPRU200.
• At this point, the procedure nurse may secure oralnasal cannula145 to the patient's face,step1222, if not already done so in the pre-procedure room.PRU200 may begin monitoring patient parameters such as, for example, ARM, ECG, and capnography now that all connections between the patient and PRU200 (via BMU300) are complete,step1223.PRU200 will continue monitoring patient parameters such as, for example, NIBP, pulse, and oximetry,step1224. Next the procedure nurse may scan the bar code label on the packaging of adrug cassette251 and place the drug cassette withinPRU200 and spike a standard drug vial,step1225 ontovial spike261. Once the fluid vial anddrug cassette64 are loaded correctly, the nurse may autoprimeIV tubing259. In one embodiment, the procedure nurse would press a button located uponPRU200 to initiate the autopriming,step1227, or the autopriming may be an automatic procedure initiated byPRU200 when all safety conditions are met. Autopriming is the automatic purging of air fromIV tubing259.PRU200 continuously monitors the autopriming process to determine the overall success of the autopriming. IfPRU200 fails to properly purgeIV tubing259, a warning notification is made to the user so that the procedure nurse may repeat the autopriming sequence untilIV tubing259 is successfully purged,step1227.
• 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,step1229. After the patient weight and dose rate have been inputted, the physician or procedure nurse may initiate drug infusion,step1230. 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,step1231. Upon completion of the procedure, the clinician may disconnect the drug delivery cassette from the catheter,step1232 and disconnect theBMU300 from thePRU200,step1233. If the clinician so desires,PRU200 may print a record of the patient's physiological parameters fromprinter454 at this time,step1234. 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,step1235.
• The patient arrives in the recovery room1240 still attached toBMU300 after leaving the procedure room. At this point,BMU300 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 thepatient1241. Depending upon clinician preference and status of the patient, the patient may require supplemental oxygen while in therecovery room1242. If the patient does require supplemental oxygen, oralnasal cannula145 is left on the patients face and oxygen is accessed from an external source such as, for example, a headwall or tank viaconnector152 and BMU connector151,step1243. If no supplemental oxygen is required in the recovery room, the nurse or technician may remove oralnasal cannula145 from thepatient1244.
• The nurse or technician may now organize ECG leads334 andARM handset342 and place nearBMU300 to be used on thenext patient1245. Alternatively,ARM handset342 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 thepatient record1246. 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 pads332 and oralnasal cannula145 may be discarded at this point into a standard waste container located in therecovery room1247. It is important to note thatBMU300 is still collecting data related to NIBP, pulse rate, andpulse oximetry1248. The nurse or technician must determine if the patient is ready to be discharged1249. 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 receiveadditional monitoring1248. Once a patient is cleared for discharge, the nurse or technician disconnectsNIBP cuff58, pulse oximeter probe, and if not done so already, oralnasal cannula145 andARM handset342 from thepatient1250. Once all the above is completed, the patient may be discharged from thecare facility1251.
• Now referring toFIG. 81, peripheralmedical display1252 receives processed patient data frommedical effector system100′ and then displays the processed patient data onperipheral LCD screen1253. Information that may be displayed includes heart rate, blood pressure, pulse oximetry, capnography, electrocardiogram, and other medical parameters that are processed bymedical effector system100′. In addition to patient data, the peripheralmedical display1252 may display procedural parameters related to the function ofmedical effector system100′. The functional parameters may include; battery charge level, duration of the current procedure, patient name, and other descriptive patient data, information related toIV pump module220, the pharmaceutical drug being supplied to the patient and other parameters. Peripheralmedical display1252 further includes the ability to allow a medical practitioner set predetermined parameter limits, which if exceeded result in an alarm action by peripheralmedical display1252 which may be in addition to any alarm generated bymedical effector system100′. The alarm action may be in the form of a flashing light from peripherallight bar1254, an auditory signal fromperipheral speaker1255, or a pop-up alarm onperipheral LCD touchscreen1253.
• Peripheralmedical display1252 may also display the output of another medical device such asendoscopic camera1256. Peripheralmedical display1252 has the capability to simultaneously display the output ofendoscopic camera1256 as well as patient and procedural data onperipheral LCD touchscreen1253. 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.
• Peripheralmedical display1252 may also contain a user interface to allow a medical practitioner to alter display settings on the peripheralmedical display1252. A user interface may be in the form ofPRU monitor touchscreen443 or peripheralmonitor LCD touchscreen1253 located on peripheralmedical display1252. 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 ofendoscopic camera1256 or may be overlaid on the output ofendoscopic camera1256. This is accomplished by a video mixing apparatus located in either peripheralmedical display1252 ormedical effector system100′. Similarly peripheralmedical display1252 may utilize a picture-in-picture display incorporating the output fromendoscopic camera1256 or other video source.
• 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.

Claims (10)

1. A medical-effector-system procedure room unit comprising a procedure-room-unit host controller which contains an oxygen delivery program which performs the steps of: controlling the delivery of oxygen at a variable first rate to at least one respiratory-gas-delivery oral prong of a cannula assembly 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 of the cannula assembly 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 when the patient is determined to be breathing through the nose and when the patient is determined to be exhaling, wherein the patient has a variable percentage of blood oxygen saturation and wherein the first, second and third rates depend on the percentage of blood oxygen saturation.

2. The medical-effector-system procedure room unit ofclaim 1, wherein 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.

3. The medical-effector-system procedure room unit ofclaim 2, wherein 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.

4. The medical-effector-system procedure room unit ofclaim 3, wherein the second rate is higher than the third rate for the same percentage of blood oxygen saturation.

5. The medical-effector-system procedure room unit ofclaim 4, wherein the third rate is zero at the predetermined high percentage.

6. The medical-effector-system procedure room unit ofclaim 1, wherein 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.

7. The medical-effector-system procedure room unit ofclaim 1, wherein 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.

8. The medical-effector-system procedure room unit ofclaim 7, wherein 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.

9. A medical-effector-system procedure room unit comprising a procedure-room-unit host controller which contains an oxygen delivery program which 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 of a cannula assembly 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 when the patient is determined to be breathing through the nose and when the patient is determined to be exhaling, wherein the patient has a variable percentage of blood oxygen saturation and wherein the nasal-inhale oxygen-delivery flow rate is a variable rate which depends on the percentage of blood oxygen saturation.

10. The medical-effector-system procedure room unit ofclaim 9, wherein the nasal-exhale oxygen-delivery flow rate is a variable rate which depends on the percentage of blood oxygen saturation, and wherein the nasal-inhale oxygen-delivery rate is greater than the nasal-exhale oxygen-delivery rate for the same percentage of blood oxygen saturation.

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