NO336780B1 - Medical effector system - Google Patents

Abstract

A medical effector system includes a bedside unit and a procedure unit. The bed edge unit includes connection points for an oral-nasal cannula and for receiving input signals from a series of patient monitors. The procedure unit includes a patient monitoring and medical effector program, and a drug delivery pump and a drug cartridge or a magnetic flux generator can deliver therapeutic energy to a patient. The medical effector program operates the pump or magnetic flux generator based on at least some of the patient outputs and program inputs. A detachable umbilical cable connects the two units and enables gases, patient monitoring information as well as other information to be sent between the two units.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application claims priority from previously submitted preliminary applications "Medical Effector System Such As a Sedation Delivery System (SDS) and Components Which Can Be Used Therein", serial no. 60/629,137, filed Nov. 18, 2004 and "Medical Effector System Such As a Sedation Delivery System (SDS) and Components Which Can Be Used Therein", Serial No. 60/605,717, filed 31 August 2004.

"Medical Effector System Such As a Sedation Delivery System (SDS) and Components Which Can Be Used Therein", serial no. 60/629,137, filed November 18, 2004 and

RELATED APPLICATIONS

The present application relates to the following commonly filed applications "Bite Block Assembly" [END5298USNP1], serial no. xx/xxx.xxx; "Apparatus For Monitoring A Patient During Drug Delivery" [END5298USNP2], serial no. xx/xxx.xxx; "Drug Delivery Cassette", [END5298USNP3], serial no. xx/xxx.xxx; [END5298USNP1], serial no. xx/xxx.xxx; "Apparatus For Delivery Oxygen To A Patient Undergoind A Medical Procedure", [END5298USNP4], serial no. xx/xxx.xxx; "Infusion Pump", [END5298USNP5], serial no. xx/xxx.xxx; "Capnometry System For Use With A Medical Effector System", [END5298USNP6], serial no. xx/xxx.xxx; "Device For Connecting A Cannula To A Medical Effector System" [END5298USNP7], serial no. xx/xxx.xxx; "Apparatus To Deliver Oxygen To A Patient" [END5298USNP8], serial no. xx/xxx.xxx; "Single Use Drug Delivery Components" [END5298USNP9], serial no. xx/xxx.xxx; "Drug Delivery Cassette And A Medical Effector System" [END5298USNP10], serial no. xx/xxx.xxx; "Oral Nasal Cannula" [END5298USNP11], serial no. xx/xxx.xxx; all submitted at the same time, and dose rate control, serial no. 10/886,225, filed Jul. 7, 2004; BIS Closed Loop Anesthetic Delivery, serial no. 10/886,322, filed Jul. 7, 2004; Patient Monitoring Systems and Method of Use, serial no. 10/792,959, filed Mar. 3, 2004; Air-Bubble-Monitoring Medication Assembly, Medical System and Method, serial no. 10/726,845, filed Dec. 3, 2003; Cannula Assembly and Medical System Employing a Know CO2Gas Concentration, serial no. 10/701,737, filed November 5, 2003; Automated Audio Calibration for Conscious Sedation, serial no. 10/674,244, filed September 29, 2003; Response Testing for Conscious Sedation Using Finger Movement Response Assembly, serial no. 10/674,184, filed September 29, 2003; Personalized Audio Requests for Conscious Sedation Utilizing a Non-Ear-Canal-Contacting Speaker, serial no. 10/674,183, filed September 29, 2003; Response Testing for Conscious Sedation Involving Hand Grip Dynamics, serial no. 10/674,160, filed September 29, 2003; Response Testing for Conscious Sedation Utilizing a Hand Motion Response, serial no. 10/673,660, filed September 29, 2003; Response Testing for Conscious Sedation Utilizing a Cannula for Support/Response, serial no. 10/670,453, filed September 25, 2003; Time Variant Vibration Stimulus Response for a Conscious Sedation System, serial no. 10/670,489, filed September 25, 2003; Response Testing for Conscious Sedation using Cableless Communication, serial no. 10/671,183, filed September 25, 2003; System and Method for Monitoring Gas Supply and Delivering Gas to a Patient, serial no. 10/660,286, filed September 11, 2003; Drug Delivery System and Method, serial no. 10/660,201, filed Sep. 11, 2003; and Battery Backup Method and System, serial no. 10/660,285, filed September 11, 2003.

The present invention generally relates to medical systems and components, which can be used in medical systems, and more specifically a medical effector system, such as a sedation delivery system, and components that can be used there.

A conscious sedation system is described in US Patent No. 6,745,764 entitled "Apparatus and method for providing a conscious patent relief from pain and anxiety associated with medical or surgical procedures". In this known system, a procedure room unit includes a controller, which generates a demand for a predetermined response from a patient. The requirement is in the form of an audio command, which is received by the patient through an earphone in the patient's ear or in the form of a vibration signal, which is received by the patient via a vibrator in a hand-held device attached to the patient's hand. The predetermined response to the demand is for the patient to operate a button on the hand-held device, whereby a switch is closed so that a signal is sent to the controller. The controller analyzes medical information from the patient. Such medical information includes, for example, blood pressure from a blood pressure cuff attached to the procedure room unit and placed on the patient's arm, and respiratory carbon dioxide levels from a cannula (which also supplies oxygen to the patient) attached to the procedure room unit and placed on the patient's face. The controller also analyzes the time delay between the request and the response. Based on the medical information and the time delay between demand and response, the controller determines the level of sedation for the patient and reduces the flow of a gaseous or IV (intravenous) conscious sedation drug to the patient if the controller determines that the patient is at a deeper level of conscious sedation than desired.

It is known to administer IV sedation drugs to a patient from a drug delivery cartridge by means of a peristaltic pump, the cartridge and pump being connected to the procedure room unit.

US 6745764 discloses a system for alleviating a patient's pain and discomfort associated with medical and operative procedures.

Scientists and engineers are constantly trying to improve medical effector systems, such as sedation delivery systems, and components that can be used in such systems.

Various embodiments of the invention include a needle device, a bite block, a drug delivery cartridge device (used in a drug delivery infusion pump device which is a type of drug delivery flow control device which is an example of a medical drug delivery effector), a medical energy delivery effector, a procedure room unit, a 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 in a medical effector system, such as a sedation delivery system.

The invention is intended to be used in a procedure with minimal sedation, moderate "conscious" sedation or in deep sedation, but not for use in anesthesia or "general anesthesia" as defined by the American Society of Anesthesiologists (ASA) in the publication "Continuum of Depth of Sedation : Definition of General Anesthesia and Levels of Sedation/Analgetisia", accepted by the ASA, delegate meeting on 13 October 1999, and amended on 27 October 2004. The ASA defines general anesthesia as a drug-induced loss of consciousness where the patient cannot be awakened, even with a painful stimulation. Patients will also often need assistance to keep the airways open, and positive pressure ventilation may be necessary because cardiovascular function may be disturbed as a result of insufficient spontaneous ventilation or drug-induced lowering of neuromuscular function.

In short, the invention provides a means for a doctor, outside the area of anaesthesia, to be able to give patients sedation and/or pain relief. The automaticity that the invention entails compensates for the lack of clear rules for how non-anesthetists can relieve conscious patients' feelings of pain and anxiety. The invention also supports the limited training available to physicians with regard to the diagnosis and treatment of complications that may arise from or as a result of sedation and analgesia of conscious patients.

The invention seeks to solve the above-mentioned problems and shortcomings with a Medical effector system as stated in claim 1.

Advantageous embodiments of the invention appear from the independent claims.

Fig. 1 is a perspective view of an embodiment of a cannula device according to the invention, including the cannula, a BMU connector (bedside monitoring unit) and tubing, as well as an embodiment of an earplug and a sound tube,

fig. 2 and 3 are sections through the hoses, taken respectively along lines 2-2 and 3-3 in fig. 1, showing separate runs carrying gases to/from the oral/nasal cannula,

fig. 4 is a perspective view of the oral/nasal cannula of FIG. 1, without connecting hoses,

fig. 5 is a section along the line 5-5 in fig. 4 through a portion of the cannula cannula and cannula housing showing the bending of a nasal breathing gas sampling branch of the cannula housing as a result of the placement of the tubing receiving hole in a nasal breathing gas delivery branch of the cannula cannula when the cannula cannula is attached to the cannula housing,

fig. 6 is a block diagram showing elements of an embodiment of an oral/nasal cannula device, including the oral/nasal cannula of FIG. 1, showing elements of an embodiment of a medical gas analysis/delivery system in 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 view of the oral/nasal cannula of FIG. 4 without needle cap,

fig. 8 and 9 are sections through the oral/nasal cannula in fig. 7, taken after lines 8-8 and 9-9 respectively in fig. 7, indicating pathways for oxygen and C02 gas,

fig. 10 is a distal end view of the BMU connector of FIG. 1 without connecting hoses,

fig. 11 is a section through the BMU connector in fig. 10, taken along the line 11-11 in fig. 10, showing the recess for the nasal humidity chamber,

fig. 12 is an enlarged section of part of the BMU connector in fig. 11 and shows details of CCV gas lines,

fig. 13 is an exploded view of the oral/nasal cannula connector of FIG. 10 and shows the outlet cover, cuff and back plate,

fig. 14 is a schematic section through the nasal moisture collection chamber of FIG. 13,

fig. 15 is a proximal connection end view of the backplate of the oral/nasal cannula connector of FIG. 13 and shows individual ports,

fig. 16 is a proximal end view of the outlet cover of that of FIG. 13 showed the oral/nasal cannula,

fig. 17 and 18 are sections through the outlet cover in fig. 16, taken respectively along the lines 17-17 and 18-18 in fig. 16, and shows paths for gases as well as humidity chamber details,

fig. 19 is a front view of a first embodiment of a bit block and part of a first alternative embodiment of a needle,

fig. 20 is a section through the bite block in fig. 19, taken along the line 20-20 in fig. 19, with a medical instrument inserted into the through passage of the bite block,

fig. 21 is a drawing as in fig. 20, but of a second embodiment of a bite block,

fig. 22 is a drawing as in fig. 20, but of a third embodiment of a bite block,

fig. 23 is a diagram showing a further embodiment of a medical effector system with a needle, where the medical effector system notifies the user of a possible problem with the needle,

fig. 24 is a perspective view of one embodiment of a drug delivery cartridge device according to the invention,

fig. 25 is a perspective view of the one in fig. 24 showed drug delivery cartridge device,

fig. 26 is an exploded view of the drug delivery cartridge device of FIG. 24, showing individual components,

fig. 27 is a perspective view of the luer base portion (also called a T-base area where the luer has a "T" shape) of the drug delivery cartridge device of FIG. 26,

fig. 28 is a perspective view of the pin area in the drug delivery cartridge device of FIG. 26,

fig. 29 is a top view of the drug delivery cartridge main plate in the drug delivery cartridge assembly of FIG. 26,

fig. 30 and 31 are sections through it in fig. 29 showed the drug delivery cartridge main plate, taken along the lines 30-30 and 31-31 of FIG. 29, showing the vial sensor screen and the T sensor screen,

fig. 32 is a perspective view of the pin in the drug delivery cartridge assembly of FIG. 26,

fig. 33 is a side view of the pin in fig. 32,

fig. 34 is a cross-section (turned ninety degrees counter-clockwise) through the pin in fig. 33, taken after lines 34-34 in fig. 33,

fig. 35 and 36 are right and left perspective views of the spigot cap in the drug delivery cartridge device of FIG. 26 showing details of the hood handle and locking system,

fig. 37 is a side view of the spigot cap in the drug delivery cartridge device of FIG. 26,

fig. 38 is a side view of the cap in the drug delivery cartridge device of FIG. 26,

fig. 39 is a top view of the spigot cap in the media delivery cartridge assembly of FIG. 26,

fig. 40 is a section through the spigot cap in fig. 39, taken along the line 40-40 in fig. 39, and shows the tap kavi teten,

fig. 41 is a perspective view of the sedation delivery system (SDS) of FIG. 6, showing an example of a medical effector system, with the procedure room unit (PRU), bedside monitoring unit (BMU) and the umbilical cord (umbilical cord);

fig. 42 is a perspective view of the SDS carriage and the one in fig. 41 showed the PRU, with a universal power supply (UPS) for the PRU,

fig. 43 is a perspective view of the one in fig. 41 showed the PRU, with the drug delivery cartridge device installed and with the pump housing door closed,

fig. 44 is a perspective view of part of that in fig. 43 showed the PRU, with the pump housing door open and without the drug delivery cartridge device installed,

fig. 45 a perspective view of a part of that in fig. 43 showed the PRU, with the drug delivery cartridge device installed and with the pump housing door open,

fig. 46 is a perspective view of part of that in fig. 43 showed the PRU, with a drug delivery cartridge device installed, with the pump housing door closed and with a drug vial (ampoule) to be inserted,

fig. 47 is a perspective view of part of that in fig. 43 showed the PRU, with a drug delivery cartridge device installed, with the pump housing door closed and with a drug vial inserted,

fig. 48 is an exploded view of the one in fig. 43 showed PRU,

fig. 49 is a perspective view of part of that in fig. 43 showed PRU,

fig. 50 is a perspective view of the oxygen delivery manifold mounted to the rear of that of FIG. 49 showed PRU,

f.g. 51 is a perspective view of the oxygen delivery manifold of FIG. 50,

fig. 52 is a section through the oxygen delivery manifold of FIG. 51, following the line 52-52 in fig. 51,

fig. 53 is an enlarged section of a portion of the oxygen delivery manifold of FIG. 52,

fig. 54 is a perspective view of the PRU host controller in that of FIG. 43 showed PRU,

fig. 55 is an exploded view of the drug delivery infusion pump device in that of FIG.

43 showed PRU,

fig. 56 is a perspective view of the one in fig. 42 showed UPS,

fig. 57 is an exploded view of the one in fig. 42 showed UPS,

fig. 58 is a schematic view of an alternative embodiment of a medical effector system according to the invention, with an energy delivery effector,

fig. 59 is a schematic diagram showing an embodiment of a medical effector subsystem with a drug delivery infusion pump subsystem, where the medical effector subsystem can alert a user of a clogged drug delivery line,

fig. 60 is a perspective view of the one in fig. 41 showed BMU, with associated connection lines,

fig. 61 is a perspective view from below of that in fig. 41 showed BMU, with disconnected connection lines,

fig. 62 is an exploded view of the one in fig. 41 showed BMU,

fig. 63 is a block diagram showing elements of an embodiment of a sedation delivery system (SDS),

fig. 64 is a block diagram showing elements of one embodiment of a procedure room unit (PRU) for use in an SDS as shown in FIG. 63,

fig. 65 is a block diagram showing elements of a system board for use with a PRU as shown in FIG. 64,

fig. 66 is a block diagram of a drug delivery module for use with a PRU of FIG. 64,

fig. 67 is a block diagram of an oxygen delivery module for use with a PRU of FIG. 64,

fig. 68 is a block diagram of a power table module for use with a PRU of FIG. 64,

fig. 69 is a block diagram of a printer module for use with a PRU according to FIG. 64,

fig. 70 is a block diagram of an uninterruptible power supply (UPS) for use with a PRU of FIG. 64,

fig. 71 is a block diagram of a UPS module for use with a UPS as shown in FIG. 70,

fig. 72 is a block diagram of a bedside monitoring unit (BMU) for use with an SDS according to FIG. 63,

fig. 73 is a block diagram of a BMU expansion board for use with a BMU of FIG. 72,

fig. 74 is a block diagram showing a display device for use with an SDS according to FIG. 63,

fig. 75 is a block diagram showing single patient details (MPU) for use with an SDS of FIG. 63,

fig. 76 is a block diagram showing multi-patient details (MPU) for use with an SDS of FIG. 63,

fig. 77 is a schematic flow chart for BMU and PRU in an SDS according to fig. 63, during an example of a surgical procedure,

fig. 78 is a data flow diagram showing the pre-medical procedure aspect of an SDS according to FIG. 63,

fig. 79 is a data flow diagram showing the medical procedure aspect of an SDS according to FIG. 63, and

fig. 80 is a data flow diagram showing a post-medical procedure aspect according to an SDS as in FIG. 63.

Fig. 81 is a perspective view of the peripheral monitor used in connection with the PRU.

Before the invention is explained in more detail, it should be noted that the invention is not limited in application or use with the features of the executions and the arrangements of parts and steps which are shown in the drawing and described below. The shown and described embodiments of the invention can be implemented or incorporated into other embodiments, variants and modifications, and can be performed or used in different ways. If not expressly stated otherwise, the words and expressions used here have been chosen to describe the embodiments according to the invention in an appropriate way for the reader, and the words and expressions are not intended to limit the invention.

A medical effector is a device intended for the delivery of at least one medical substance and/or at least one type of medical energy locally and/or generally to a patient in connection with 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 a gas, a liquid and/or a solid which alone and/or together will have a medical effect on a patient, where it may for example be a pharmaceutical drug. Medical energy is energy that has a medical effect on a patient. An example here, without limitation, is a sedative effect. The term "sedative effect" includes conscious sedation and unconscious (anaesthetic) sedation, all depending on the type and/or amount of medical substance and/or medical energy used. In connection with the description of 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, again without limitation, of a medicinal substance that has a sedative effect is the sedative drug Propofol. An example, without limitation, of a medical effector for delivering Propofol to a patient is a drug delivery flow control device, such as a drug delivery infusion pump device. An example, without limitation, of a type of medical energy that has a sedative effect is a time-varying magnetic field as described in US Patent 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 a magnetic flux generator described in US Patent No. 6,712,753. Thus, a sedation delivery system where a sedation drug delivery current control device is used and a sedation delivery system where at least one magnetic flux generator is used will be examples of medical sedation effector systems. Other examples of medical effector systems, medical effectors, medical substances, drugs, types of medical energy, medical effects and medical procedures will be known to those skilled in the art. It should be mentioned that the words and expressions given below such as "connected", "connected", "connected" and "connected" include direct or indirect connection, direct or indirect connection, direct or indirect connectability, and direct or indirect connections. It should also be noted that a description of a device that has a particular component means that the device has at least one such component. In the same way, the description of a component that has a special feature means that the component has at least one such feature.

Various aspects and embodiments of the invention will now be described in connection with a sedation delivery system 100 and a sedation drug delivery flow control device 220', but it should be understood that such aspects and embodiments have the same validity with regard to other examples of medical effector systems 100' than a sedation delivery system 100 and/or other examples of medical effectors 220" than a drug delivery current control device 220'. Such other examples include, without limitation, a medical effector system that includes a non-sedating drug delivery current control device and a medical effector system that includes at least one magnetic flux generator.

It shall also be understood here that one or more of the below described aspects, embodiments, aspects of embodiments, examples etc. can be combined with one or more of the other below described aspects, embodiments, aspects of embodiments, examples etc.

Cannula device

A first inventive aspect concerns one or a component of a cannula device 145. An embodiment of such a device is shown in fig. 1-18. A first aspect of the embodiment in fig. 1-18 is a cannula device 145 that includes an oral-nasal cannula 351 and a sliding tube 371'. The oral-nasal cannula 351 can be placed on the face of a patient 10 and includes a nasal breathing gas sampling branch 364 or 365 and an oral breathing gas sampling branch 369'. The sliding tube 371' is slidably connected to one of the nasal and oral breathing gas sampling branches 364, 365 or 369' to adapt to different distances between the nose and the mouth of patients 10.1 example, the sliding tube 371' is slidably connected to the oral breathing gas -the sampling branch 369', the sliding tube 371' having a substantially right-angled bend and a distal end 14. The oral-nasal cannula 351 is arranged on the face of the patient 10, and the distal end 14 of the sliding tube 371' extends distally towards or into the patient's 10 mouth. Other possible examples will be found by those skilled in the art.

A second aspect of the embodiment in fig. 1-18 is a cannula assembly 145 that includes a cannula 351' (such as, without limitation, an oral-nasal cannula 351) and a user-detachable oral branch extension 370' or 370". The cannula 351' can be placed on the face of a patient 10 , and it includes an oral breathing gas sampling or delivery branch 3697371' or 369"/371" with an opening. The user-detachable oral branch extension 370' or 370" is releasably associated with the oral branch 3697371' or 369"/371" and is user-connectable to the opening in the oral branch 3697371' or 369"/371". In an example of the second aspect of the embodiment in FIG. 1-18, the oral branch 369' or 369" lacks the sliding branch 371' or 371", while this will not be the case in other examples. In one implementation of the second aspect, the oral branch extension 370' or 370" is connected to the opening in the oral branch when the user uses a bite block (not shown), such as with an esophageal procedure requiring an endoscope. In one embodiment, the user may - the detachable oral branch extension 370' or 370" is detached manually by the user without the use of tools. In one embodiment, the oral branch extension 370' or 370" will be releasably connected to the oral branch 3697371' or 369"/371" by means of a manually breakable connection 12. Alternative embodiments include releasable connection by means of lines of weakness or perforations. Other examples, implementations and embodiments will be conceivable by those skilled in the art.

A third aspect of the embodiment in fig. 1-18 is a cannula assembly 145 that includes a cannula 351', which cannula can be disposed on the face of a patient 10 and includes an oral breathing gas sampling branch 3697371' with a distal end 14 and an oral breathing gas delivery branch 369"/371" with a distal end 16. When the cannula 351' is placed on the patient's 10 face, the distal end 14 of the oral breathing gas sampling limb 3697371' will extend distally further towards or into the patient's 10 mouth than the distal end 16 of the oral breathing gas sampling branch 3697371' delivery branch 369"/371". In an example of this third aspect of the embodiment in fig. 1-18, the oral breathing gas sampling branch 3697371' is a carbon dioxide breathing gas sampling branch, while the oral breathing gas delivery branch 369"/371" is used to deliver oxygen-enriched air (sometimes simply referred to as "oxygen") to the patient 10.1 this example the displacement of the distal ends 14 and 16 to the two branches 3697371' and 369'7371" will reduce the oxygen dilution in the carbon dioxide sample, as those skilled in the art will know. Other examples will be appreciated by those skilled in the art.

A fourth aspect of the embodiment in fig. 1-18 is a cannula device 145 which includes a cannula 351', which can be placed on the face of a patient 10 and which includes left and right cannula support wings 367' and 367", both of which have a wingtip portion with an adhesive pad 366 that can be releasably attached to the face of the patient 10. In one example, no other attachment means are used for attaching the cannula 351' to the face of the patient 10. In this example, the adhesive pad 366 provides a more appropriate cannula attachment to the patient than the use of a conventional headband etc. Other examples will could imagine.

A fifth aspect of the embodiment in fig. 1-18 is a cannula assembly 145 which includes a

cannula 351', which can be placed on the face of a patient 10 and includes a cannula housing 18 with a nasal breathing gas sampling limb 364 or 365, as well as a cannula capsule 368 with a nasal breathing gas delivery branch 422 with a tubing receiving hole 26. The cannula capsule 368 is attached to the cannula housing 18 with the nasal breathing gas sampling branches 364 or 365 passed through and out past the hose receiving hole 26. The hose receiving hole 26 is arranged for bending the nasal breathing gas sampling branch 364 or 365 towards the patient's 10 nose when the cannula 351 is arranged on the patient's 10 face. Such an arrangement allows for better breath gas sampling, as those skilled in the art will appreciate. In an example of the fifth aspect of the embodiment of FIG. 1-18, the nasal branch 364 or 365 is designed mainly just before the needle capsule 368 is attached to the needle housing 18.

A sixth aspect of the embodiment in FIG. 1-18 is a cannula device 145 that includes a cannula 351', which can be placed on the face of a patient 10 and that includes a nasal breathing gas sampling branch 364 or 365 with a distal end 20, and a nasal breathing gas delivery branch 422' or 422 " with a distal end 22. When the cannula 351' is placed on the face of the patient 10, the distal end 20 of the nasal breathing gas sampling branch 364 or 365 will extend distally further towards or into one of the nostrils of the patient 10 than the distal end 22 of the nasal breathing gas delivery branch 422' or 422". Such displacement of the distal ends 20 and 22 of the two branches 364 or 365 and 422' or 422" will reduce the respiratory-delivered gas dilution of the breath gas sample, as will be appreciated by those skilled in the art. In an example of the sixth aspect of the embodiment in FIG. 1-18, the nasal breathing gas sampling branch 364 or 364 is surrounded by the nasal breathing gas delivery branch 422' or 422". Professionals will be able to imagine other examples.

A seventh aspect of the embodiment of FIG. 1-18 is a cannula assembly 145 that includes an oral-nasal cannula 351 and a connector 363. The oral-nasal cannula 351 can be placed on the face of a patient 10 and includes a breathing gas sampling tube 354 for the left nostril, a breathing gas sampling tube 352 for the right nostril and an oral breathing gas sampling tube 355. The connector 363 includes a cover 394 and a back plate 423 which is connected to the cover 394. The cover 394 includes an internal nasal moisture collection chamber 412 and an internal oral moisture collection chamber 411 which is separate from the internal nasal moisture collection chamber 412 The back plate 423 includes a nasal capnometry port 402 and an oral capnometry port 400. The left and right respiratory gas sampling tubes 354 and 352 are connected to the cover 394 and are in fluid communication with the inner nasal moisture collection chamber 412. The oral respiratory gas sampling tube is 355 is connected to the cover 394 and has a fluid connection with the inside ige oral moisture collection chamber 411. The nasal capnometry port 402 is in fluid communication with the inner nasal moisture collection chamber 412. The oral capnometry port 400 is in fluid communication with the inner oral moisture collection chamber 411.

In an example of the seventh aspect of the embodiment in fig. 1-18, the connector 363 also includes a hydrophobic filter 395' disposed between the inner nasal moisture capture chamber 412 and the nasal capnometry port 402, and a hydrophobic filter 395" disposed between the inner oral moisture capture chamber 411 and the oral capnometry port 400.1 a another example, not shown, is a desiccant arranged in the nasal and oral moisture collection chambers 412 and 411 respectively. Other examples will be found by those skilled in the art.

In a variant of the seventh aspect of the embodiment in fig. 1-18, the connector 363 also includes a flow path sealing cuff 396 disposed between the inner nasal and inner oral moisture collection chambers 412 and 411 and the nasal capnometry and oral capnometry ports 402 and 400. The cuff 396 has annular towers 24 that extend into the nasal and oral capnometry ports 402 and 400, respectively, thereby at least partially providing a fluid connection between the inner nasal moisture capture chamber 412 and the nasal capnometry port 402, respectively, between the oral moisture capture chamber 411 and the oral capnometry port 400.

An eighth aspect of the embodiment of FIG. 1-18 is a cannula device 145 that includes a nasal cannula 351 and a connector 363. The cannula 351 can be placed on the face of a patient 10 and includes a breathing gas sampling tube 354, 352 or 355. The connector 363 includes a cover 394, a back plate 423 and a cuff 396. The back or back plate 423 is attached to the cover 394. The cover 394 includes an internal moisture collection chamber 412 or 411. The back plate 423 has a capnometry port 402 or 400. The breath gas sampling tube 354, 352 or 355 is connected to the cover

394 and is in fluid communication with the internal moisture capture chamber 412 or 411. The capnometry port 402 or 400 is in fluid communication with the internal moisture capture chamber 412 or 411. The cuff 396 is located between the internal moisture capture chamber 412 or 411 and the capnometry port 402 or 400. The cuff 396 has an annular tower 34 that extends into the capnometry port 402 or 400 and thereby at least partially provides fluid communication between the internal moisture capture chamber 412 or 411 and the capnometry port 402 or 400.

A ninth aspect of the embodiment of FIG. 1-18 is a cannula device connector 363. The cannula device connector 363 includes at least one cannula device connector element with a nasal capnometry port 402, an oral capnometry port 400, a nasal pressure port 401, and a breathing gas delivery port 399. Each of the ports 402 . 100'). The term "fluid connectable" includes a direct fluid connectability and an indirect one.

In an example of the ninth aspect of the embodiment of FIG. 1-18, at least one needle device connector element consists of a plate (for example, the back plate 423). In the same or in another example, each of the ports 402, 400, 401 and 399 has a center and the distance between the centers of two ports 402, 400, 401 and 399 is shortest for the nasal capnometry and nasal pressure ports 402 and 401.1 a variant of the ninth aspect, the at least one cannula device connector element has an audio port 398. In one embodiment, the connector 363 includes a back plate 423, where one or more or all of the ports 402, 400, 401 and 399 (and when present also the port 398) is ports in the back plate 423.1 a variant has the back plate 423 adapter tabs 397 for aligning and/or support in a connection of the ports 302, 400, 401 and 399 (and when present, also the port 398) with the BMU 300.1 a modified version the back plate 432 is designed as shown in fig. 13 and 15.1 another embodiment, not shown, the connector 363 lacks a plate or a back plate. In one arrangement, BMU 300 has ports that cooperate with ports 402, 400, 401 and 399 (and when present, also port 398) in connector 363, thereby providing fluid connection. In another arrangement, ports 402, 400, 401 and 399 (and when present, also port 398) in connector 363 cooperate with ports in BMU 300, thereby providing the fluid connection. Other arrangements (including connector ports flush with the backplate, not shown) that provide fluid communication between the connector ports and the BMU will be contemplated by those skilled in the art.

In an implementation of the ninth aspect of the embodiment of FIG. 1-18, the bedside monitoring unit (BMU) 300 may be fluidly connectable to a procedure room unit (PRU) 200 (an embodiment of which is shown in Figs. 6 and 41-57) in the sedation delivery system (SDS) 100 (or in a other medical effector system 100'). The procedure room unit 200 includes an oral capnometer 202 and a nasal capnometer 140 (see Fig. 54). When the oral and nasal capnometry ports 400 and 402 in the connector 363 are fluidly connected to the bedside monitoring unit 300 and this unit is fluidly connected to the procedure room unit 200, the oral capnometer 202 will have fluid connection to the oral capnometry port 400 while the nasal capnometer 140 will have fluid communication with the nasal capnometry port 402. The term "fluid communication" includes both direct and indirect fluid communication.

A tenth aspect of the embodiment of FIG. 1-18 is a cannula water collection subassembly 28 that includes a cannula water collection housing 30 and a hydrophobic filter 395. The cannula water collection housing 30 has a moisture collection chamber 411 or 412 with a moisture collection cavity 32 and a breath gas sample passage cavity 34. The breath gas sample passage cavity 34 is arranged higher than, and in fluid communication with, the moisture collection cavity 32. The breathing gas sample passage cavity 34 has a smaller volume than the moisture collection cavity 32. The breathing gas sample passage cavity 34 has a breathing gas sample inlet and a breathing gas sample outlet. The hydrophobic filter 395 is arranged to cover the exit from the breathing gas sample passage cavity 34. All breathing gas samples 36 entering the breathing gas sample passage cavity 34 must pass through the hydrophobic filter 395 in order to exit the breathing gas sample passage cavity 34. Moisture in the breathing gas sample 36 is collected in the moisture collection cavity 32.

An eleventh aspect of the embodiment of FIG. 1-18 is a cannula device 145 that includes a cannula 351', a connector 363 and an audio earplug 362. The cannula 351' can be placed on the face of a patient 10 and includes a breath gas sampling tube 354, 352 or 355. The breath gas sampling tube 354, 352 or 35 is fluidly connected to the connector 363, and the connector 363 can be connected to a bedside monitoring unit 300 in a sedation delivery system 100 (or other medical effector system 100'). The audio earplug 362 may be disposed near the patient's 10 ear and is operatively connected to the connector 363 to emit a sound to the patient 10, at least as provided by the bedside monitoring unit 300, when the connector 363 is connected to the bedside monitoring unit 300 and audio the earplug 362 is disposed near the ear of the patient 10. The term "near" includes, without limitation, "in" and "on".

In an example of the eleventh aspect of the embodiment of FIG. 1-18, the audio earplug 362 is placeable in the ear of the patient 10, and the cannula device 145 includes an audio tube 356 that is operatively connected to the audio earplug 362 and to the connector 363. This audio tube transmits acoustic sound from a speaker in the bedside monitoring unit (BMU ) 300 and to the audio earplug 362 when the connector 363 is connected to the BMU 300. In one embodiment, the BMU 300 uses the audio earplug 362 to give the patient 10, in the pre-procedure room, practice commands for clamping an automatic response monitor (for example, a handheld device ) thereby establishing a patient response time while the patient is conscious. In one variant, an exercise computer program in the BMU 300 can influence the speaker during such an exercise. Subsequently, the patient 10, in the procedure room where the person concerned is sedated, will be supplied with operative orders for clamping the automatic response monitor on request or demand from a procedure room unit (PRU) 200 in the sedation delivery system 100 (or another medical effector system 100'). The PRU 200 uses at least the patient response time to determine a level of consciousness for the patient 10 undergoing the sedation (or other type of medical procedure). In one variant, there is a computer program in the PRU 200 which affects the loudspeaker during the sedation of the patient. In another application, the patient in the pre-procedure room can be given soothing sounds, such as music, through the sound earplug 362. Another example, the sound earplug 362 can be a speaker in a headset, since the sound tube 356 will be replaced by an electric wire. Professionals will be able to think of other examples.

In an application of some of the previously described aspects of fig. 1-18, including examples, etc., the cannula device 145 may be connected directly to the bedside monitoring unit (BMU) 300. For example, in an application of the seventh aspect of the embodiment in FIG. 1-18, the connector 363 can be directly connected to the bedside monitoring unit (BMU) 300, whereby inlet ports in the BMU 300 enter the small annular towers 24 on the cuff 396 and press the towers 24 against the assigned nasal and oral capnometry ports 402 and 400 , thereby providing a leak-free seal. In another application of one of the previously described aspects of fig.

1-18, including examples etc, the cannula assembly 145 may be directly connectable to a device (not shown) that remains in the procedure room. For example, in another application of the seventh aspect of the embodiment in fig. 1-18, the connector 363 be directly connectable to a device (not shown) which remains in the procedure room. In one variant, the unit not shown may include the delivery of one or more sedation drugs to the patient 10, while the device (not shown) in another variant does not include the delivery of sedation drugs to the patient. Other applications will be understood by those skilled in the art.

One or more of the previously described aspects of the embodiment in fig. 1-18, including examples etc, can be combined with one or more of the previously described aspects of the embodiment in fig. 1-18, including examples etc, as those skilled in the art will be able to imagine.

Figs. 19 and 20 show a first embodiment of a bite block 74. According to an example, this bite block is used together with the cannula device 145 in fig. 1-18.1 an example a bite block is used for a patient in connection with an upper gastro-intestinal endoscopic medical procedure. The bite block includes a bite block body, which is inserted into the patient's mouth. The bite block body has a continuous passage for the introduction of an endoscope. The patient bites on the bite block instead of the endoscope.

A first aspect of the embodiment in fig. 19 and 20 is a bite block 74 with a bite block body 76 designed for insertion into the mouth of a patient. The bite block body 76 has a through passage 78 and an air sampling passage 80 arranged at a distance from the through passage 78. The through passage 78 is intended for the insertion of a medical instrument 82 (only a part of which is shown in Fig. 20). The air sampling passage 80 has an inlet 84 arranged for receiving exhaled air from the patient when the bite block body 76 is inserted into the patient's mouth. The air sampling passage 80 has an outlet 86 intended for connection to a breathing gas sampling port 88 in a cannula 90 (only the housing/capsule portion of an embodiment of an oral/nasal cannula without a breathing gas delivery branch is shown). In a variant, the outlet 86 from the air sampling passage 80 can be designed for indirect connection to the breathing gas sampling port 88 in the cannula 90 through a connector tube 92.

A second aspect of the embodiment in fig. 19 and 20 is a cannula assembly 94 that includes a cannula 90, a bite block 74 and a connector tube 92. The cannula 90 can be placed on the face of a patient and includes a breathing gas sampling port 88. The bite block 74 has a bite block body 76 for insertion into the patient's mouth. The bite block body 76 has a through passage 78 and an air sampling passage 80 arranged at a distance from this. The through passage 78 is designed for the passage of a medical instrument 82. The air sampling passage 80 has an inlet 84 arranged for receiving exhaled air from the patient when the bite block body 76 is inserted into the patient's mouth, and has an outlet 86. The connector tubing 92 has a first end attached to or attachable to the breathing gas sampling port 88 in the cannula 90 and has a second end attached to or attachable to the bite block body 76 at the outlet 86 from the air sampling passage 80 in the bite block body 76.

Fig. 21 shows a second embodiment of a bite block. An aspect of the embodiment in FIG. 21 is a bite block device 96 which includes a bite block body 98 and an air sampling tube 102. The bite block body 98 is designed for insertion into the patient's mouth and has a through passage 104 for the passage of a medical instrument 106 (only a portion of this instrument is shown). The air sampling hose 102 is connected to the bite block body 98 and has an inlet 108 for receiving exhaled air from the patient when the bite block body 98 is in the patient's mouth, as well as an outlet 112 connected or connectable to a breathing gas sampling port in a cannula.

In a variant of the embodiment in fig. 21, the air sampling tube 102 is at least partially arranged in the through passage 104.1 one embodiment the air sampling tube 102 can be adhesively attached to the bite block body 98.1 one embodiment the outlet 112 of the air sampling tube 102 can be designed for indirect connection to the breathing gas sampling port in the cannula by means of a connector tube 118.

Fig. 22 shows a third embodiment of a bite block. An aspect of the embodiment in FIG. 22 is a bite block device 122 which includes a bite block body 124 and an air sampling tube 126. The bite block body 124 is intended for insertion into the mouth of a patient. The bite block body 124 has a through passage 128 for the passage of a medical instrument 132 (only a portion of this instrument is shown) and also includes an air sampling passage 134. The air sampling tube 126 is at least partially disposed in the air sampling passage 134, and it has an inlet 136 disposed for receiving exhaled air from the patient when the bite block body 124 is placed in the patient's mouth, as well as an outlet 138 which is connected or can be connected to a breathing gas sampling port in a cannula. In one variant, the outlet 138 from the air sampling tube 126 is designed for indirect connection to the breathing gas sampling port in the cannula by means of a connector tube 148.

Examples of the designs in fig. 19 and 20, 21 and 22 have the advantage that the air sampling passage/tube is maintained in a suitable air sampling position despite any movement of the instrument in the through passage during a medical procedure. This results in a more accurate measurement of carbon dioxide gas concentrations in the patient's exhaled air than when a conventional bite block and cannula arrangement is used, where a cannula is used with an air sampling tube that does not stay in place in relation to the bite block.

Fig. 23 shows yet another embodiment of a medical effector system 154, which medical effector system 154 can notify a user of a possible problem in a cannula 156 in the medical effector system 154. An aspect of the embodiment in fig. 23 is a medical effector system 154 that includes a pressure sensor 158, a cannula 156, and a memory 166. The pressure sensor 158 has an input 168 and an output signal 170. The cannula 156 can be placed on the face of a patient and includes a breathing gas sampling tube 172 that can be connected with the pressure sensor 158's input 168. The memory 166 includes a cannula program that, run in a processor 174, will be operatively connected to the output signal 170 from the pressure sensor 158. The cannula program notifies a user of a possible problem in the cannula 156, based at least in part (and in an example completely) on the output signal 170 from the pressure sensor 158. It should be noted here that in one example the input 168 in the pressure sensor 158 can be designed for receiving a pneumatic signal in the form of a breathing gas from the patient.

In an embodiment of the one in fig. 23, the output signal 170 from the pressure sensor 158, when the cannula 156 is positioned on the patient's face and the breathing gas sampling tube 172 is operatively connected to the pressure sensor 158's input 178, may correspond to the pressure generated by the patient's breathing, which will be a time-varying signal in accordance with the patient's breathing rate. If a cannula 156 is not arranged on the patient's face and/or if the breathing gas sampling tube 162 in the cannula 156 is not operatively connected to the input 168 of the pressure sensor 158, then the output signal 170 (typically a

electrical signal) from the pressure sensor 158 could essentially be equal to the atmospheric pressure.

In an embodiment of the embodiment in fig. 23, the breathing gas sampling tube 172 may be designed for sampling breathing gas from at least the mouth, left nostril and/or right nostril of the patient. In a variant, not shown, the breathing gas sampling tube can be designed for sampling breathing gas from the mouth and both nostrils of the patient. In another variant, not shown, the breathing gas sampling tube can be designed for sampling breathing gas from both patient nostrils. In another variant, the breathing gas sampling tube 172 can be designed for sampling breathing gas from the patient's left nostril, right nostril and/or mouth.

In an embodiment of the embodiment in fig. 23, the possible cannula problem includes a cannula 156 not positioned (or not positioned properly) on the patient's face when the cannula program is run on the processor 174.1 the same or a different embodiment, the possible cannula problem can include the cannula 156 not being operatively connected to the pressure sensor 158 input 168 when the cannula program is run in the processor 174.

In an application of the embodiment in fig. 23, the pressure sensor 158 is a component of a bedside monitoring unit (for example, the bedside monitoring unit 300 in Fig. 3, where the pressure sensor 158 will then replace the nasal pressure transducer 47). In the same or a different application, the memory 166 and the processor 174 may be components of a host controller in a procedure room unit (such as the host controller 204 in the procedure room unit 200 of FIG. 6). In one variation, the medical effector system 154 may also include an umbilical cable (such as the umbilical cable 160 in Fig. 6). In such a variant, the cannula program will automatically start running after the bedside monitoring unit and the procedure room unit are operatively connected to each other by means of the umbilical cable, when at least one of the bedside monitoring unit and the procedure room unit is turned on. In one embodiment, the possible problem with the cannula may include that the umbilical canal is not connected (or not properly connected) to the bedside monitoring unit and the procedure room unit. In one modification, the procedure room unit may include a capnometer 230 and 234 operatively connectable to the cannula 156, and the cannula program starts the capnometer 230 and 234 if the cannula program does not alert the user of a possible problem with the cannula 156.1 another application can the pressure sensor 158, the memory 166, the processor 174 and the capnometer 230 and 234 be components of a single unit.

In an arrangement of the one in fig. 23, the breathing gas sampling tube 172 can be an oral breathing gas sampling tube 236, and the cannula 156 also includes a breathing gas sampling tube 238 for the left nostril, which tube is operatively connectable to the pressure sensor 158's input 168. In addition, the cannula 156 includes a breathing gas sampling tube 240 for right nostril, which tube is operatively connectable to the pressure sensor 158 inlet 168. In one variant, at least one valve 242, 244 and 246 may be controlled by the cannula program for selective operative connection of the pressure sensor 158, one at a time, to the oral breathing gas sampling tubes 236, 238 and 240 for the left and right nostrils respectively. Other embodiments may use a different number of valves, have different valve designs and/or other valve connections than those shown in fig. 23, which those skilled in the art will be able to understand. In one modification, the medical effector system 154 also includes at least one capnometer 230 and 234, the at least one valve 242, 244 and 246 being operable by the cannula program for operative connection of the left and right oral breathing gas sampling tubes 236, 238 and 240 nostrils to the at least one capnometer 230 and 234. In one application, the at least one capnometer 230 and 234 includes a nasal capnometer 230 that receives breath gas sampling input signals from the patient's two nostrils, and an oral capnometer 234 that receives breath gas sampling input signals from the patient's mouth . In one implementation, the nasal capnometer 230 and the oral capnometer 234 are components of a procedure room unit (such as the aforementioned procedure room unit 200). It should be noted that in fig. 23, the connections between the processor 174 and the capnometers 230 and 234 and between the processor 174 and the at least one valve 242, 244 and 246 have been omitted for the sake of clarity. In other arrangements, not shown here, two or three pressure sensors can be used.

In other embodiments, not shown, of a medical effector system that alerts the user to a possible problem with a needle, each valve 242, 244, and 246, which in one example also has an off position that blocks any flow from the valve) may fig. 23 is replaced by a splitter which divides the associated breathing gas sampling tube into a branch connected to the associated capnometer and another branch connected to the pressure sensor. In one variant, two or three pressure sensors and/or one, two or three capnometers can be used. It should be noted that in one application the strongest pressure signal from a breathing site may identify the best breathing site for use in capnometer measurements of carbon dioxide in the patient's exhalation.

In one example, advantages of the medical effector system 154 would include automatically notifying the user of a possible problem with the cannula 156, without the use of less reliable mechanical switches and with the provision of baseline pressure measurements for a patient's oral and nasal breathing. Such baseline pressure measurements are used in an application to later determine whether the patient's preferred breathing opening has changed, after which the oxygen flow to the patient undergoing a medical procedure can be increased or decreased.

The following sections represent a detailed description of a particular embodiment of the embodiment in fig. 1-18. It should be mentioned that any feature in this particular embodiment can be used in other of the aforementioned aspects (including the examples) of the embodiment in fig. 1-18.1 this particular embodiment, the cannula device 145 is an oxygen-delivering cannula device (the term "oxygen" herein includes oxygen-enriched air), more specifically, a cannula device 145 (shown in FIG. 1) that delivers oxygen to a patient 10 and collects orally and nasal exhalation for analysis. The oral/nasal cannula 351 enables a measurement of end-rhythmic CO2 gas (the term "CO2 gas" shall herein include gas containing CO2) from both the oral and nasal cavities, as well as a measurement of the CO2 gas pressure from combined nasal cavities.

The oral/nasal cannula 351 brings a stream of oxygen directly into the oral and nasal cavity, unlike prior art cannulae, which deliver oxygen as a mist outside the oral or nasal cavities. The cannula device 145 includes a nasal pressure sensor lead that delivers a signal to an oxygen controller to reduce the oxygen flow during exhalation, thereby preventing dilution of the gas sample, which will increase measurement accuracy. The cannula 145 enables independent oral and nasal capnometry measurement, in contrast to previously known capnometry cannulae, where the sampling is combined so that an average measure is obtained. The invention also includes a connector 363 as an integral part of the cannula system, thereby facilitating the attachment and detachment relative to the bedside monitoring unit (BMU) 300. The cannula 145 also enables the delivery of audio commands to a patient requiring a response to an automatic response monitor (ARM).

In one embodiment, the oral/nasal cannula 351 can be of a soft and yielding material which can easily be deformed and provide a comfortable adaptation to the patient's 10 face. This ensures comfort for the patient 10 and minimizes irritation.

The needle assembly 145 (shown in Fig. 1) is part of an integrated monitoring and sedation delivery system (SDS) intended to provide a safe means of administering sedation drugs in conjunction with surgical procedures. The system uses a drug delivery algorithm and an intravenous-infusion-peristaltic pump to deliver drugs at a variable rate to achieve and maintain a desired sedation effect. All drug delivery is carried out using the procedure room unit (PRU) 200, which together with a bedside monitoring unit (BMU) 300 enables the healthcare personnel to make necessary drug dosage changes from another location.

As used herein, the term "proximal" shall refer to a location in the oral/nasal cannula device that is closest to the device where the cannula device is used and thus farthest from the patient 10 where the cannula device is used. Conversely, the term "distal" shall refer to a place farthest from the device where the cannula device is used and closest to the patient 10.

As shown in fig. 1-3, the oral/nasal cannula 351 is designed for comfortable fit at the patient's 10 upper lip, between the nose and the mouth. The oral/nasal cannula 351 acts as a mask-free delivery device for supplying oxygen gas to a patient 10, with the simultaneous possibility of monitoring the patient's 10 breathing. The oral/nasal cannula 351 is connected to a tubing set for collection of gas samples, delivery of sound and oxygen, and includes a tensioner 361 for holding the equipment on the patient 10, an earplug 362 that enables the sending of audio messages to the patient 10, and a BMU connector 363 for secure connection with the bedside monitoring unit (BMU) 300.

In fig. 1 through 6, the cannula assembly 145 includes an earplug 362 distal to the oral/nasal cannula 351, and a proximal connector 363. Exhalation samples from the patient 10 are collected by the oral/nasal cannula 351 and flow through independent channels and runs to the connector 363. The connector 363 is releasably connected to the bedside monitoring unit (BMU) 300. Gas (oxygen and CO2) is sent via the umbilical to/from the procedure room unit (PRU) 200. The capnometry system includes two capnometers in the PRU 200. A hydrophobic particle filter is arranged inside the cannula connector 363. The the oral chamber 411 and the nasal chamber 412 are designed to collect condensation from the patient's 10 exhalation, thereby avoiding moisture damage to the capnometers. A nasal pressure transducer 47 is provided in the bedside monitoring unit 300. The pressure transducer 47 provides patient breathing information to the procedure room unit (PRU) 200 through the umbilical cable.

As shown in fig. 4, the oral/nasal portion 351 is made of a soft and flexible material, such as polyurethane, silicone, or another elastomer, and is typically made either by injection molding or by liquid injection molding. The needle capsule 368 is essentially a hollow cube and constitutes a platform for the placement of other details. The profile of the oral/nasal portion 351 is designed for easy adaptation to the patient's 10 anatomy. The oral/nasal cannula 351 includes adhesive pads 366 which are arranged on the cannula wings 367 towards the sides facing the patient 10 and are intended for secure and comfortable attachment and retention of the cannula 351 on the patient's 10 face. The needle capsule 368 includes a nasal branch 422 and an oral branch 369. The needle housing 18 has nasal branches 364 and 365 and oral branches 370 and 371.

Fig. 4 and 6-9 show that the cannula capsule 368 has two independent gas circuits, one for collecting orally and nasally exhaled CO2 for capnometry and pressure analysis, and a second circuit for supplying oxygen to the patient's 10 nose and mouth. Fig. 8 shows a section through a CCV sample circuit in the oral/nasal cannula 351. The CCV sample circuit includes a left and right nostril circuit and an oral sample circuit, formed in and connected in the cannula capsule 368. The left CCV circuit consists of a left branch channel 375 and a left channel 377, connected to each other at right angles and intended for collecting CCV samples from the patient's 10 left nostrils. The left sample tube 354 (Fig. 1) is inserted and fixed in the left channel 377, so that the CCV sample volume is divided into two runs (shown in Figs. 2, 3 and 6): a left pressure run 359 and a left test run 360.1 additionally includes the right CCV circuit a right branch channel 374 and a right channel 376, connected to each other at right angles and intended for collecting CCV samples from the patient's 10 right nostrils. The right sample tube 352 (Fig. 1) is inserted and fixed in the right channel 376, whereby the CCV sample volume is divided into two runs (shown in Figs. 2, 3 and 6): a right pressure run 357 and a right test run 358. The arrangement is in essentially the same for an oral circuit that includes an oral branch channel 379 with oral branches 369, 371 and 370, and an oral channel 378 in the needle capsule 368. The oral branch channel 379 and the oral channel 378 are connected and collect CCV samples from the patient's 10 mouth.

As shown in fig. 7-9, a second gas circuit supplies oxygen near the patient's 10 nose and mouth. Fig. 9 shows a section through an oral/nasal cannula 351. The oxygen channel 387 is in fluid communication with the chamber 384 in the cannula capsule 368. The oxygen chamber 384 has three openings: a first opening to an oxygen branch channel 381, which supplies oxygen to the vicinity of the mouth; a second opening to the right channel 385 which supplies oxygen to the right nostril; and a third opening which supplies oxygen to the left nostril through channel 386.

As shown in fig. 4, nasal oxygen branches 422 are mounted above branches 364 and 365. Branches 422 have a tapered shape and are fitted coaxially around nasal branches 364 and 365. Branches 422 have a number of holes that allow passage of oxygen from the cannula capsule 368 to the vicinity of the patient's 10 nostrils .

The oral system consists of oral branches 369 which are an integral part of the oral-nasal cannula 351, sliding branches 371 which are slidably mounted over the branches 369, and the EGD

(esophageo-gastro-duodenoscopy) branch extension 370. The oral branch system has two independent channels: the oxygen branch channel 381 for oxygen supply; and the oral branch canal 379 for collection of CCV samples. The sliding branches 371 are slidably mounted over the branches 369 with an L shape and provide flexibility relative to the various patients 10. The branches 369 are extensible and reversible for easy placement in front of the mouth. A third part of the oral branch system is detachable/fixable branch extension EGD (esophageo-gastro-duodenoscopy) branches 370, intended for sliding mounting on the sliding branches 371 to thereby be able to enter the patient's 10 mouth. The EGD branch extension 370 is manufactured connected to the branches 371, but can be easily detached by the user. The EGD extension 370 improves the delivery and collection of gases in the mouth, but can be easily removed and discarded when not in use.

As shown in fig. 1, the tube set consists of two extruded tubes 352 and 354 for transporting nasal CCV specimens. Each tube set has two small runs, a tube 355 for transporting the oral CO2 sample, a sound tube 356, and an oxygen tube 353 for transporting oxygen into the chamber 384 (shown in Figs. 7-9). The tubes are commercially available and advantageously consist of a compliant plastic material such as extruded polyvinyl chloride. Each extruded tube 352 and 354 transports CCV samples from the right and left nostrils, respectively. The sample tube 352 is connected to the needle capsule 368 by the oxygen tube 353 on the right side. In a similar arrangement, the sample tube 354 is connected to the needle cap 368 at the oral sample tube 355 on the left side.

As shown in fig. 2 and 3, the right pressure passage 357 and the right sample passage 358 are arranged in the tube 352 and transport CCV gas samples from the right nostril for pneumatic and capnometry analysis. The left pressure passage 359 and the left sample passage 360 are arranged in the tube 354 for transporting CCV gas samples from the left nostril. In one arrangement, the tube 352 is connected to the oxygen tube 353, and in the same way the tube 354 can be connected to the oral sample tube 355. The connection between the tubes is made so that the tubes can be easily separated from each other if necessary. A separate sound pipe 356 is attached to the earplug 362 and is used for transporting sound to the patient's 10 ear.

As shown in fig. 13, the oral/nasal cannula connector 363 consists of four components that together form internal chambers and channels. The components are the outlet cover 394, the hydrophobic filter 395, the gasket 396 and the back plate 423. The components are held together by means of internal latches 403 which are snapped into and locked in internal grooves 404. It will now be referred to fig. 10-13 and 15-18. The outlet cover 394 and the back plate 423 are of molded and rigid thermoplastic, while the gasket 396 is of an elastic and flexible material. In the outlet cover 394 there are moisture chambers 411 and 412 for capturing moisture from oral and nasal CCV sample gases. The outlet cover 394 has gripping portions 388 that facilitate the user in attaching the connector assembly to the BMU interface connector (shown in Fig. 1). Left and right nasal CCV gases are combined in the recess 415 after passing through the capnometry outlet channels 417 (shown in Figs. 16-18). The nasal capnometry analysis is carried out with the combined gas sample in the PRU 200 (see fig. 6). A pressure analysis is also carried out for a combined gas sample after the CCV gases have passed through pressure lines 424 (fig. 12).

Oral capnometry analysis is performed for a CO 2 gas sample, which is taken after the gas has passed through the oral outlet channel 416 and entered the oral recess 410 and the humidity chamber 411 (see Fig. 6). The recesses 410 and 415 hold a hydrophobic filter 395 which captures moisture and enables drainage of this into the moisture chambers 411 and 412, so that moisture damage to other sensitive parts of the capnometry system is thereby avoided.

As shown in fig. 1 and 10-13, the outlet cover 394 has distal side connectors for all cannula tubes. The distal side of the cover 394 includes an oxygen tube opening 390, which is the connection point of the tube 353, a sound tube opening 389 which is the connection point of the tube 356, a right tube opening 392 that receives the sample tube 352, a left opening 393 for connection with the sample tube 354, and an oral tube opening 391 for receiving the oral test tube 355. All the connection points are designed for a leak-proof connection with the assigned tube. Both right and left nasal CO2 pressure lines 418 (see Fig. 16) are connected to pressure passage openings 421 in recess 420.

As best shown in fig. 13 and 15, the gasket 396 is sandwiched between the outlet cover 394 and the backing plate 423. The purpose of this gasket is to provide internal channels and to isolate individual flow paths. It also serves to secure the hydrophobic filter 395. The hydrophobic filter 395 is also held by means of a filter groove 419 and projection 413 on the outlet cover 394's proximal side. The hydrophobic filter 395 is commercially available and is particle blocking and hydrophobic. The back plate 423 has a number of openings for cooperation with the connector in the BMU 300 (fig. 1). These openings include a sound opening 398, an oxygen opening 399, an oral opening 400 and a pressure opening 401. Adapter tabs 397 serve to control the connection between the needle connector 363 and the connector on the BMU 300.

It should be mentioned that in the detailed description of the embodiment shown in fig. 1-18, the cannula 351', the connector 363 and the ear plug 362 are single patient (SPU) items.

MEDICATION DELIVERY CASSETTE DEVICE

A second inventive aspect relates to a component that is part of or can be used in a drug delivery cartridge device 251. An embodiment is shown in fig. 24-40 and can be used in an embodiment of a procedure room unit (PRU) 200 which is shown in fig. 41-57. A first aspect of the embodiment in fig. 24-40 is a drug delivery cartridge assembly 251 that includes a cap 269, tubes 277 and 259, and a drug delivery cartridge main plate 253. The tubes 277 and 259 have a drug receiving end, which is in fluid communication with a drug vial 250 containing a drug, and the tubes further have a drug delivery end that is fluidly connected to the luer 269. The term "fluid connectable" includes both a direct fluid connectability and an indirect one, and the term "fluid connected" includes both direct and indirect fluid connections. The cassette main plate 253 has a base part 271. The hat 269 can be put on and detached from the base part 271. The base part 271 for the hat has a sensor screen 275 which is deflected by the hat 269 when it is attached to the base part 271. The screen will go back when the hat 259 is detached from the base part 271 The base part 271 may also be referred to as a T-base 271, and the sensor screen 275 may also in one embodiment be referred to as a T-sensor screen 275. Those skilled in the art will understand that other embodiments will be possible.

In an example of the first aspect of the embodiment in FIG. 24-40, the cartridge head plate 253 can be releasably connected to a procedure room unit (PRU) 200 (shown in Figs. 41-57) having an optical luer-in-place sensor 226 (see Fig. 44) arranged to sense either a deflected sensor screen 275 or a non-deflected sensor screen 275.1 one variant, the procedure room unit 200 will control the drug flow in the tubes 277 and 259 to air purge the tubes 277 and 259 and to deliver the drug through the tube to a patient, based at least in part on the optical sensor 226 sensing or does not sense the luer sensor system 275. Those skilled in the art will understand that there are other possible designs.

A broad description of a combination of the second inventive aspect (a drug delivery cartridge device as shown in Figs. 24-40) and a later discussed third inventive aspect (a procedure room unit embodiment as shown in Figs. 41-57) relates to a drug delivery device (for example the drug delivery cartridge device 251 and the procedure room unit 200). In one aspect of the combination, the drug delivery device (eg, 251 and 200) has tubing (eg, 277 and 259), a reservoir (eg, the luer base portion 271), a pump (eg, 220 as shown in FIG. 41), and a sensor (eg, the optical the sensor 226 for the luer, as shown in Fig. 33). The tubes (eg, 277 and 259) have a drug receiving end that can be fluidly connected to a drug vial (eg, 250) containing a drug, and have a drug delivery end (eg, the luer 269). The storage location (eg, 271) is intended for releasable storage of the drug delivery end portion (eg, 269) for the tubes (eg, 277 and 259) when the drug delivery end portion is not in drug delivery communication with a patient. The pump (for example, 220) controls the flow of drug in the tubes (for example, 277 and 259) when connected to the pump (for example, 220), for air purging of the tubes (for example, 277 and 259) and for delivery of the drug through the tubes (for example, 277 and 259 ) and to the patient. The sensor (eg, 226) has an output and is arranged to sense the presence or absence of the drug delivery end (eg, 269) of the tube (eg, 277 and 259) in the storage location (eg, 271).

It should be noted that in an example of the more broadly described combination herein, the drug delivery end portion will have a length of generally 2.5 to 10 cm (1-4") and it includes any end fitting (for example, the luer 269) associated with the drug delivery end portion of the tubes (eg, 277 and 259). In one embodiment, the sensor will directly sense the presence and/or absence of the drug delivery end (eg, 269) in the storage location (eg, 271). In another embodiment, the sensor (eg, 226) will indirectly sense the presence and/or absence of the drug delivery end (eg 269 ) by sensing the presence and/or absence of another component (eg the sensor template 275 ) that changes position corresponding to the presence and absence of the drug delivery end (eg 269 ) for the tubes (eg 277 and 259 ) at the storage site (eg 271 ) It should be mentioned that the components mentioned here are not limited to the special examples so m is indicated by the parentheses. It is thus conceivable to use other types of sensors, for example another optical sensor, an ultrasonic sensor, a proximity sensor or an electromagnetic sensor. Similarly, other examples of storage locations are conceivable, and the drug delivery system is not limited to the use of a drug delivery cassette device and/or a procedure room unit, which those skilled in the art will be able to understand.

In one implementation of the drug delivery device (eg, 251 and 200), the pump (eg, 220) will send air through the tubes (eg, 277 and 259) only when the drug delivery member (eg, 269) is stored at the storage location (eg, 271), a storage that is determined with the sensor (for example 226). This helps prevent inadvertent treatment (ie, air flushing) of the tubing (eg 277 and 259) when the drug delivery end (eg 269) is in fluid communication with the patient.

In the same or a different implementation of the drug delivery device (eg, 251 and 200), the tubes (eg, 277 and 259) are removable from the pump (eg, 220) only when the drug delivery end portion (eg, 269) of the tubes (eg, 277 and 259) is stored in the storage location (eg 271), determined using the output from the sensor (eg 226). This helps to prevent a free flow of medication into the patient or the surroundings. In one variant, a pump housing door (for example, 201) will pinch the connected tubing (for example, 277 and 259) against the pump (for example, 220) so that a pumping action is required for the drug flow and this is closed (ie, no free flow exists) when the pump (for example 220) do not pump. In this variant, the pump housing door (eg, 201) is locked and cannot be opened to remove the pinched tube (eg, 277 and 259) unless the drug delivery end (eg, 269) for the tubes (eg, 277 and 259) is stored in the storage location (eg, 271), which determined with the output from the sensor (eg 226).

A second aspect of the embodiment in fig. 24-40 is a drug delivery cartridge device 251 that includes a drug delivery cartridge main plate 253. A drug vial 250 can be attached to the cartridge main plate 253. The cartridge main plate 253 has a deflectable drug vial sensor screen 267 that is deflected by the drug vial 250 when it is attached to the cartridge main plate 253. The sensor screen will be undeflected when the drug vial 250 is not is associated with the cassette main plate 253. This sensor screen 267 can also be referred to as a tap sensor screen 267. Those skilled in the art will be able to imagine other embodiments.

In an embodiment of the second aspect of the embodiment in fig. 24-40, the cartridge head plate 253 may be releasably associated with a procedure room unit (PRU) 200 (shown in Figs. 41-57). An optical drug vial-in-place sensor 228 (see FIG. 44) is arranged to sense the deflected sensor screen 267 or the non-deflected sensor screen 267. Alternatively, the procedure room unit 200 will control the flow of drug from the drug vial 250, based at least in part on whether the optical sensor 228 senses or does not sense the position of the sensor screen 267.

In the same or in another example of the second aspect of the embodiment in fig. 24-40, drug vial 250 has a drug vial seal 42, and the drug delivery cartridge device 251 includes a pin 261 with a tip 296 and a tip 184. When the drug vial 250 is connected to the cartridge main plate 253, the seal 42 will be perforated by the tip 296 and held open by the tip 184. Drug Vial - the sensor screen 267 will press the drug vial 250 against the pointed edge 184. Such a pressure effect will reduce drug spillage. Professionals will understand the significance of this. Professionals will be able to think of other examples.

A third aspect of the embodiment in fig. 24-40 is like a drug delivery cartridge device 251 having a drug delivery cartridge spike 261. A drug vial 250 can be attached to the spike 261. The drug vial 250 has a seal 42. The spike 261 has a tip 296 and a tip egg 184. When the drug vial 250 is inserted onto the spike 261 , the seal 42 will be broken by the tip 296 and held open by the tip edge 184.

A fourth aspect of the embodiment in fig. 24-40 is a drug delivery cartridge assembly 251 that includes a cap 269, a drug delivery cartridge spike 261, tubes 277 and 259, and a drug delivery cartridge head plate 253. The spike 261 has a tip 296 for perforating a seal on the vial. The tubes 277 and 259 have a drug receiving end that is fluidly connectable to and fluidly detachable from the spike 261, and has a drug delivery end that is fluidly connected to the luer 269. The spike 261 can be releasably connected to the cassette main plate 253. This makes it possible that only the spike 261 needs to be disposed of in a corresponding waste container, whereby waste volume and associated costs can be saved. Professionals will understand the significance of this.

A fifth aspect of the embodiment in fig. 24-40 is a drug delivery cartridge assembly 251 having a cap 269, tubes 277 and 259 and a drug delivery cartridge head plate 253. Tubes 277 and 259 have a drug receiving end fluidly connected to a drug vial 250 containing a drug and having a drug delivery end fluidly connected to the luer 269. The cassette main plate 253 has a luer base part 271. The luer 269 can be releasably connected to the luer base part 271. The luer base part 271 has a drip chamber 273 for collecting medicine coming from the luer 269 when the luer 269 is connected to the luer base part 271. The Luer base part 271 can also in one embodiment be referred to as a T-base 271. Those skilled in the art will understand that there are other design possibilities. In an example of the fifth aspect of the embodiment of FIG. 24-40, the drug delivery cartridge device 251 also has a drug-absorbing pad 273' which is arranged in the drip chamber 272. Those skilled in the art will understand that other embodiments may exist.

A sixth aspect of the embodiment in FIG. 24-40 is a drug delivery cartridge device 251 that includes a cap 269 and tubes 277 and 259. The tubes 277 and 259 include a coiled tube 259 and a flexible tube 277 that are in fluid communication with each other. The flexible tube 277 has a drug receiving end that is fluidly connectable to a drug vial 250 containing a drug, and the coiled tube 259 has a drug delivery end that is fluidly connected to the luer 269. The coiled tube 259 can be extended by the user. In an example of the sixth aspect of the embodiment of FIG. 24-40, the coil tube 259 has several windings and adjacent windings are releasably joined together. Such an arrangement enables the user to then only extract a necessary length of the coiled pipe 259, which provides better pipe handling. In a variant, adjacent windings can be thermally connected. In another variant, irradiation during a sterilization can lead to a releasable joining together of adjacent windings in the coil tube 259.1 the same or in another example, the coil tube 259 can have a smaller inner diameter than the flexible tube 277. This will reduce drug leakage that remains in the tubes 277 and 259 after use, and such a design will also facilitate the removal of air during an initial flush. Professionals will be able to think of other examples.

A seventh aspect of the embodiment of FIG. 24-40 is a drug delivery cartridge device 251 that includes a drug delivery cartridge main plate 253 that can be releasably connected to a procedure room unit 200 in a sedation delivery system 100 (or another type of medical effector system 100') and that includes a recess 254 for a peristaltic pump. In an example of the seventh aspect of the embodiment in FIG. 24-40, the drug delivery cartridge device 251 also has a flexible drug delivery tube 277 with a substantially linear section connected to the main plate 253 and extending over the recess 254 for the peristaltic pump. When the main plate 253 is connected to the procedure room unit 200, this section of the flexible tube 277 is connected to the pump fingers of a peristaltic drug delivery pump in the procedure room unit 200.

An eighth aspect of the embodiment of FIG. 24-40 is a drug delivery cartridge device 251 that includes a drug delivery cartridge main plate 253. This main plate 253 has an upper left part, an upper right part, a right bottom part and a left bottom part. The cartridge head plate 253 is releasably attachable to a procedure room unit 200 in a sedation delivery system 100 (or another type of medical effector system 100'). The main plate 253 has a recess 254 for a peristaltic pump between the left and right upper parts. The main plate 253 has a recess 255 for an air-in-line sensor between the upper right part and the lower right part.

In an example of the eighth aspect of the embodiment of FIG. 24-40, the drug delivery cartridge device 251 also has a flexible drug delivery tube 277 with an essentially linear first section which is connected to the upper left and upper right parts of the main plate 253 and spans the recess 254 for the peristaltic pump. Furthermore, it has an essentially linear second section which is associated with the upper right part and the right bottom part of the main plate 253 and spans the recess 255 for the air-in-line sensor. When the main plate 253 is connected to the procedure room unit 200, the first section of the flexible tube 277 will be drive connected with the pump fingers of a peristaltic drug delivery pump in the procedure room unit 200. The second section of the flexible tube 277 is drive connected to an air-in-line sensor in the procedure room unit 200.

In the same or another example of the eighth aspect of the embodiment of FIG. 24-40, the lower left portion of the main plate 253 extends below the lower right portion of the main plate 253 and forms a recess for a pump door lock to the left of the lower left portion and below the lower right portion of the main plate 253.

In an embodiment of one of the previously described aspects of fig. 24-40, with the examples, etc., the cassette main plate 253 is directly connectable to a procedure room unit (PRU) 200 (shown in Fig. 41.57). Those skilled in the art will appreciate other embodiments.

One or more of the previously described aspects of the embodiment in fig. 24-40, including the examples etc, can be combined with one or more of the previously described aspects of the embodiment in fig. 24-40, including the examples etc, as professionals will be able to understand.

In the paragraphs given below, a more detailed description of a special embodiment of the embodiment in fig. 24-40. It should be mentioned that features of this special

the embodiment can be used in the previously described aspects (including the examples etc.) of the embodiment in fig. 24-40.1 this embodiment the drug delivery cartridge device 251 is used together with a drug delivery infusion pump device 220.1 this embodiment the drug delivery cartridge device 251 is part of a

integrated monitoring and sedation delivery system (SDS) 100 (shown in Fig. 41) for administration of sedation drugs. The system uses a drug delivery algorithm and a peristaltic (or other type) intravenous infusion pump 220 (Fig. 41), along with the drug delivery cartridge device 251, to deliver drugs at varying infusion rates to achieve and maintain a desired sedation effect.

As used herein, the term "proximal" shall refer to a location of the drug delivery cartridge device 251 closest to the device where the device 251 is used, and thus farthest from the patient for whom the drug delivery cartridge device 251 is used. Similarly, the term "distal" shall refer to a location farthest from this device where the drug delivery cartridge device 251 is used, and closest to the patient.

As shown in fig. 24-26, the cartridge 251 consists of a cartridge head plate 253 which, in one example, is molded from hard thermoplastic having a generally flat rectangular shape, with smooth rounded corners and rectangular recesses 254 and 255 which are designed to allow interface with a peristaltic pump 220 ( see Fig. 41) and its sensor components (eg 226 and 228 as in Fig. 44). In one embodiment, the cassette 251, including the main plate 253 and components are single-patient use components and are disposable. The cartridge head plate 253 comprises a generally flat thin base formed with molded features to support fluid connection tubes 277 and 359, a reducer 281, a spike system 272 and a commercial cap 269. Spike system 272 includes spike cap 263, spike 261, air vent filter 295 and spike arc 265.

Again with reference to fig. 24.-26, the cassette main plate 253 has a top side 252 and a bottom side 260, where the components included in the cassette 251 are placed. The cassette main plate 253 has a recess 254 for a peristaltic pump on the proximal side. On the sides of the main plate 253, a recess 255 is arranged for an air-in-line sensor and a pipe passage 258. A visible arrow mark 289 is generally relief-shaped centrally on the main plate 253, and the arrowhead shows the user which insertion direction applies to the cassette 251. A alignment hole 287 is designed as a round opening through the main plate 253 and represents an aid for the user with regard to positioning and alignment of the cassette 251 in the pump 220 (see fig. 41).

As shown in fig. 24-26, here the cartridge main plate 253 has a reinforcement rib 256 on the top side 252 and parallel reinforcement ribs 286 on the bottom side 260, thereby increasing the rigidity of the plastic molded structure 253 at the pump recess 254 and the sensor recess 255. The reinforcement rib 256 and the reinforcement ribs 286 help to make main plate 253 rigid, so that it can be handled and used more easily. The reinforcement rib 256 and the reinforcement ribs 286 are integrally formed with and form parts of the cassette main plate 253.

As shown in fig. 24 and 26, the cassette main plate 253 has: (a) a coil tube base 257 intended to receive the coil tube 259; (b) a T-base 271 for holding the hat 269; and (c) a stud bearing 262 for receiving the stud system 272. The cassette head plate 253 also has a gripping section 285.

As shown in fig. 26, the grip portion 285 is an integral part of the cassette main plate 253, and extends from the distal side to thereby facilitate user handling. The grip section 285 is made with rounded corners so that it is easy and comfortable to grip. Parallel ribs 190 are designed on the upper side of the grip section 285. This is to provide a good non-slip surface that enables a good grip when inserting or removing the cassette 251 from the pump 220 (see fig. 41).

As shown in fig. 24 and 26, the drug delivery system mounted in the cartridge 251 consists of a set of flexible tubes that have a fluid connection. The tubing assembly includes (a) a coiled tubing 259 and (b) a flexible tubing 277. The medication system also includes: (c) a reducer 281; (d) a spike system 272 mounted in the spike bed 262; and (e) a commercial cap 269 mounted in a T-base 271.1 in one embodiment all parts are releasably mounted for handling and transport.

As shown in fig. 25 and 26, the tube 277 is a transparent and flexible plastic tube, for example of commercially available PVC, with a constant inner diameter and outer diameter. The tube 277 is made of a flexible and yielding material which enables bending through the passage 258 and fitting into the clip 279. The tube 277 mainly follows the outer contour of the cassette. In the cassette 251, clips 279 and track wall holders 291 are used for guiding the pipe 277, the cross-section of the pipe being mainly kept constant at the corners of the cassette 251 and in the passage 258.1 an embodiment, not shown, the track wall holders 291 can be replaced with one or more additional clips 279.

As shown in fig. 25 and 26, the tube 277 is part of the drug fluid connection system and is connected at one end to (a) a spiked elbow 265, while at the other end it is connected to (b) a reducer 281. The tube 277 is connected to the spiked elbow 265 of the cassette's 251 bottom page. From there, the pipe 277 runs across the cassette 251, and goes from the cassette's bottom side 260 and through the pipe passage 258. The other end of the pipe 277 is connected to the reducer 281 on the cassette's 251 upper side. The pipe 277 extends freely over the recesses 254 and 255. The pipe 277 thus crosses the recess 255 for the air-in-line sensor and the recess 254 for the peristaltic pump.

As shown in fig. 24, 26 and 29, the flexible tube 277 is held in place by means of shaped clips 279 on the upper side 252 of the cassette. The clips 279 have alternating openings to thereby keep the tube 277 aligned and in place without distortion. The clips 279 have a general curvature adapted to the outer circumference of the tube 277. The clip openings 270 and 276 appear during production for the shaping of the clips. Double clips 280 fix the reducer 281 on the cassette main plate 253. In one embodiment, the double clips 280 are arranged with only a small mutual clearance (as shown in Fig. 29), for good retention of the reducer 281 and anchoring of the pipe system. The clips 280 have a curved shape adapted to the outer contour of the reducer 281. Double clips 280 hold the two rings on the reducer 281 in a fixed position, and prevent sliding movement during handling or use. The reducer 281 has a flat bottom, and the cartridge head plate 253 has a reducer positioning rib 40 (shown in Fig. 29 but omitted from Fig. 26 for ease of reference), which rib also helps the reducer 281 remain in place when attached with double clips 280.1 an example, the tube 277 is kept tight and straight after the connection with a peristaltic pump 220, which is achieved with the clips 280.

As shown in fig. 26 and 29, the track wall holders 291 are molded on the upper side 252 of the cassette for holding the pipe 277 in the corner bends. The distance between the walls is such that the pipe 277 is easily clamped and thereby held in place. As previously mentioned, in an embodiment not shown, the track wall holders 291 can be replaced with one or more additional clips 279.

As shown in fig. 26, the reducer 281 is part of the fluid connection system, and it is mounted on the cartridge 251 proximal part. In one embodiment, the reducer can be made of a transparent thermoplastic material and has an inlet and an outlet in fluid connection, the inlet and outlet being arranged at approximately right angles to each other. The inlet end of the reducer 281 is larger than the outlet. The outlet end is intended for connection with an IV (intravenous) coiled tube 259, while the inlet end is intended for connection with the flexible tube 277. The main body of the reducer 281 has a substantially cylindrical shape, with two molded rings for cooperation with clips 280 that hold the reducer in place . The reducer 281 also helps to hold smaller diameter coiled tubing 259 and larger diameter flexible tubing 277 in place.

As shown in fig. 26 and 27, the coil tube 259 is a transparent IV tube, for example of commercially available PVC, manufactured and arranged as a mainly cylindrical spiral in order to thereby minimize the overall size and facilitate the user's handling of the tube. In one embodiment, the coil tube 259 in its fully extended length has a length of approx. 2.4 m (8 ft). This will be a sufficient length for the user, for stretching the coiled tube 259 between the cassette 251 and the patient. In one embodiment, the coil tube 259 is stored in the cartridge 251 in a semi-cylindrical shaped base 257 which is designed to prevent movement when the cartridge 251 is transported and installed in the pump 220. One end of the coil tube 259 is attached to the reducer 281 while the other end is connected to the luer 269. In use, the medical personnel will remove the luer 269 from the T-base 271, release the luer 269 from the first luer clip 274 and from the second luer clip 297, and then pull and unwind the tube 259 as necessary to reach the patient. It should be noted that the inner flow path of the tube 259 is minimized compared to the flexible tube 277, thereby minimizing drug spillage, i.e. drug remaining in the tube after use, and to promote removal by air in conjunction with an air flush.

As shown in fig. 24, 27 and 29-31, the T-base 271 is designed for releasably holding the hat 269. The T-base 271 has a deflectable integrated screen 275. This screen is in contact with the hat 269 when the hat 269 is put in place, so that thereby the screen 275 will deflect and interact with an optical sensor 226 in the procedure room unit (PRU) 200 (shown in Figs. 41-57). The T-base 271 further includes an open drip chamber 273 which is used as a reservoir for catching and holding medication spills during flushing of the medication line. The T-base 271 has built-in walls to provide an inclined socket (as shown in Fig. 35) on the cassette upper side 252. The T-base 271 has two shaped clips. The first and second luer clips 274 and 297, respectively, hold the luer 269. The T-base 271 includes a small tower 278. The luer 269 sits on top of the tower 278, with an oblique angle to thereby control drug spillage into the chamber 273.

As shown in fig. 27 and 29, the drip chamber 273 is an integral part of the T-base 271 and in one embodiment will be a shaped part of the cassette main plate 253. The drip chamber 273 is generally arranged in a central area of the cassette main plate 253. The drip chamber 273 has a substantially rectangular shape, with a wall together with the T-tower 278, and is dimensioned to be able to occupy a specific volume of the total contents of the medication vial 250 (see fig. 32). The drip chamber 273 acts to prevent spillage during flushing and to catch drug residues after using the cassette. In one variant, the drip chamber 273 has an absorbent pad 273' for absorbing drained drugs.

As shown in fig. 25-27 and 29-31, the T-sensor template 275 is formed as an integral part of the cassette main plate 253 and acts as a cantilever screen. The pivot point of the screen 275 is on the cassette 251's distal side at the top of the T-tower 278. In one embodiment, the free-hanging end of the screen 275 passes through the cassette's bottom side 260 and into a central elongated opening in the T-base 262 (as shown in Fig. 31). , which interfaces with the optical sensor 236 in the PRU 200. The overhanging end of the screen 275 is substantially shaped like a T. One tip of the "T" contacts the luer 269. When the luer 269 is inserted into the base 271, the screen 275 is deflected and the second T tip will then refract the light beam to the optical sensor 226 indicating that the T base is now occupied. Thereby, it is indicated in the PRU 200 (shown in Fig. 41-57) that the luer 269 has been put in place, so that a flushing of the medication line can be carried out.

As shown in fig. 26 and 27, it concerns a cap 269 which is commercially available and will be well known in the medical field. The hat is made of a rigid plastic material. In one embodiment, the luer 269 is T-shaped, with an internal barrel that has fluid connection with all three legs of the T. A T-leg is connected to the coil tube 259. Another T-leg has a needleless opening that can be connected to an IV luer fitting. The last T-leg has a removable dust cap.

As shown in fig. 26, 28 and 32-34, the spike bed 262 is a recessed area in the cassette main plate 253, which area is arranged at a small angle so that when the spike 261 is mounted on the main plate 253, the spike 261 will be mainly vertically oriented when the cassette 251 is placed in the pump 220 in PRU 200 (shown in fig. 41-57). The vertical position of the spike 261 contributes to proper and complete emptying of the medication vial 250 when it is placed on the spike 261. The spike bed 262 has walls for receiving a spike wing 197. The spike bed 262 has two guide pins 299 and two openings 292 for aligning the spike device 261 at the bottom. the central area of the spike bed 262 has a semi-cylindrical base 199 for receiving an air vent boss 177. The air vent boss's base 199 forms a step with a round contour for holding the hollow spike 261 in place. Centrally in the spike bed 262, i.e. at the bottom, there is a round opening for introducing a spike drug boss 185.1 longitudinally, in the middle of the spike bed 262, there is a recess for a spike sensor screen 267, which has a flat and curved shape. The spike sensor screen 267 is attached as a cantilever screen at the proximal side of the spike bed 262.

As shown in fig. 29-34, the cantilever spike sensor shield 267 (shown in FIG. 30) is an integral part of the cassette main plate 253. At the outer end of the spike shield 267 is provided a lower spike tab 290, arranged to cooperate with an optical vial-in-place- sensor 228 on the PRU 200 pump 220 (shown in Fig. 41). An upper spike tab 288 represents a second tab that is disposed in an intermediate position along the shield 267 and is positioned to cooperate with a drug vial 250 when the vial 250 is placed on the spike 261. This upper spike tab 288 passes through the opening 198 in the spike wing 197 when the spike 261 is mounted on the cartridge head plate 253. When the cartridge assembly 251 is placed in the pump 220 of the PRU 200 (shown in Figs. 41-57), and when a drug vial 250 is placed on the spike 261, the vial will contact the upper spike tab 288 and cause the spike sensor screen 267 is deflected sufficiently so that the lower spiked tab 290 can interact with the optical sensor 228, which indicates that a vial has been inserted, in the PRU 200. Thereby it is indicated in the PRU 200 that a drug vial 250 has been inserted and that a flush can be carried out and that the PRU 200 pump 220 can deliver medication to the patient.

As shown in fig. 24, 26 and 32-34, the spike system 272 consists of a spike cap 263, a spike 261 and a spike elbow 265. The spike cap 263 protects medical personnel from accidental stabbing effects of the spike tip 296. The spike cap 263 is releasably arranged on top of the spike tip 296 and is held with a locking mechanism. The spiked bow 265 is releasably threaded (with a luer lock) to the drug boss 185. The spiked bow 265 attaches the spike 261 to the cassette main plate 253. Unscrewing the spiked bow from the drug boss 185 enables the spike 261 to be easily removed from the cassette main plate 253, so that the spike 261 can be thrown in a suitable container, which minimizes the total volume of waste and also leads to savings in terms of costs in connection with disposal.

As shown in fig. 32-34, the spike 261 is molded from a rigid thermoplastic material and two internal runs that run substantially parallel to the length of the spike 261. The spike 261 is designed with a general cylindrical shape, has a perforation tip 296 and a spike wing 197, which serves as a base for the spike tip 296. The spike 261 includes a spike egg 184 to prevent a drug vial 250 from slipping off the spike tip 296. The spike tip 296 has a first inclined surface 186 and a second inclined surface 187. The first inclined surface 186 has a drug opening, in fluid connection with the drug course 195. The second inclined surface 187 has an air-vial opening, which has an airway connection with the air ventilation course 196. In use, a seal becomes 42 on the drug vial perforated with the spike tip 296 and held open with the spike tip 184.

As shown in fig. 26 and 32-34, the drug barrel 195 has fluid connection between the spike tip 296 and the drug channel 294. Externally for the drug channel 294 there is a drug boss 185. The outside of the drug boss 185 is the thread 193 for connecting the spike elbow 265. The air ventilation barrel 194 has fluid connection with the air ventilation channel 293. Externally for the air ventilation channel 193 is an air ventilation boss 177. The air ventilation passage 194 is used to equalize the air pressure in the medication vial 250, thereby enabling fluid to flow under the influence of gravity from the medication vial 250 and through the medication passage 195 and into the medication tube. In one embodiment, an air ventilation filter 295 (as shown in Fig. 26) is used, which filter is commercially available and is snapped onto the air ventilation boss 177. In general, the air ventilation filter 195 has a cylindrical shape, with a fine lattice structure at one end. The air ventilation filter 295 is permeable to the release of gases, including air, in both directions through the air ventilation channel 293, but prevents the passage of liquid and solid materials in both directions through the air ventilation channel 293.

As shown in fig. 26, 28, 32-40, the spike 261 has a flat wing 197 designed as a substantially trapezoidal thin plate, with rounded corners. The flat and thin design of the spike wing 197 facilitates the user's handling and forms a support for the spike cap 263. Two spike openings 191 are aligned with spike base openings 292 and serve to align the spike 261 with respect to the vial centering mechanism in the PRU 200. Spike alignment openings 298 are used for alignment by introduction of the spike 261 in the cassette 251, and they cooperate with spike pins 299, for aligning the spike 261 in the spike bed 262.

As shown in fig. 32-40, the spike 261 has a snap lock 189 on top of the spike wing 197. This snap lock 189 is integrally formed with the spike wing 197 and cooperates with a spike lock 284 on the spike cap 263 to hold the spike cap 263 in place over the spike 261.

As shown in fig. 24 and 32-40, the spike cap 263 is made of a rigid thermoplastic material and constitutes a protective device for the spike system 272. The spike cap 263 has a head 176 in the form of a hollow body, for covering the spike tip 296. The spike cavity 181 has a generally elongated shape and enables the setting of the spike cap 263 over the spike tip 296. The spike cap 263 includes a handle 182 to facilitate the user's handling of the cap. On each side of the handle 182 are arranged gripping ribs 178. A locking mechanism includes a pin lock 184 and two carrier arms, a first arm 179 and a second arm 180, both formed in one on each side of the head 176. The pin lock 284 has a spring-like design and can be deflected normally on the head's 176 axis. When the spike cap 263 is placed on the spike tip 296, the lock 284 will be deflected under the influence of the snap lock 189 on the spike 296, whereby the lip 183 is locked at the edge of the snap lock 189. The first and second arms 179 and 180 prevent the spike cap 263 from tilting. As shown in fig. 24, 26, 28-31, the cartridge main plate 253 has two cap fastening ribs 38 which enable a releasable snap connection between the spike cap 263 handle 182 and the cassette main plate 253. A rapid upward force on the handle 182 will cause the spike cap 263 to be detached from the spike 261 and from the cap holder ribs 38.

As shown in fig. 25 and 26, the spiked elbow 265 is made of a rigid thermoplastic material and has an essentially cylindrical shape with two openings which are connected to an internal fluid channel 264. One opening in the fluid channel 264 is connected to the tube 277. The other opening in the channel 264 has fluid connection with the drug channel 294 in the spike 262, and enables drug to flow under the influence of gravity from a spiked vial and through the drug barrel 195, and further through the tube or hose 277. The spike arc 265 has an internally threaded ring which enables a detachable attachment of the spike arc 265 to the spike boss 185 (see fig. 33). When the spike 261 is properly positioned on the cartridge head plate 253, the spike elbow will hold the spike 261.

The drug delivery cartridge 251 is intended for single patient use (SPU) and is manually loaded into a pump cartridge compartment 219 in a procedure room unit (PRU) 200 (shown in Figs. 41-57). The pump cartridge compartment 219 has a hinged door which serves to press the cartridge 251 against the peristaltic pump 220. The cartridge 251 includes an intravenous tube which connects to a catheter for the patient.

PROCEDURE ROOM UNIT

A third inventive aspect relates to, or a component of, or can be used in a procedure room unit 200. An embodiment of this unit is shown in fig. 41-57. A first aspect of the embodiment in fig. 41-57 is an infusion pump device 220 for drug delivery, which pump includes an infusion pump housing 239, a cartridge device 251 (an embodiment of which is described above and shown in more detail in Figs. 24-40), and a pump housing door 201. The drug delivery cartridge device 251 can be connected to the infusion pump housing 239 and has a drug vial spike 261 (see Fig. 32). The pump housing door 201 is connected to the infusion pump housing 239, has an open and closed position and has drug vial alignment fingers 44. The drug vial alignment fingers 44 center and align drug vials 250 of various diameters when the cassette device 251 is connected to the infusion pump housing 239, the pump housing door 201 is in its closed position, and a drug vial 250 is inserted between the alignment fingers 44 for cooperation with the spike 261.

In one embodiment of the first aspect of the embodiment in FIG. 41-57 center and align the drug vial aligning fingers 44 drug vials 250 with ten and twenty cubic centimeters and with different outer diameters and with the same or different lengths. In one variant, the centering fingers 44 essentially consist of two yielding, concave and opposing fingers. In the same or another embodiment, the pump housing door 201 is rotatably connected to the infusion pump housing 209 and can be pivoted between an open and closed position. A person skilled in the art will be able to imagine other embodiments and variants.

In an example of the first aspect of the embodiment in FIG. 41-57, the cassette device 251 can be inserted into and removed from the infusion pump housing 239 when the pump housing door 201 is in its open position. In the same or another example, the drug-delivering infusion pump device 220 may also include a drug-delivering peristaltic pump 232 which is arranged in the infusion pump housing 239 and has pump fingers 229.1 this example, the cassette device 251 is drive connected to the pump fingers 239 when the cassette device 251 is connected to the infusion pump housing 239 and the pump housing door 201 is in open position.

In an application of the first aspect of the embodiment of FIG. 41-57, the drug delivery infusion pump device 220 is part of a procedure room unit (PRU) 200 in a sedation delivery system (SDS) 100 (or another type of medical effector system 100') where the SDS 100 (or another type of medical effector system 100') also includes a bedside monitoring unit (BMU) 300 and an umbilical cable 160.1 such an embodiment, the BMU 300 has a first series of connection points for receiving input signals from patient monitoring connections and a second series of connection points for issuing patient parameters, as well as a display screen showing patient parameters. In such an embodiment, PRU 200 is used during a medical procedure and for receiving patient parameters from BMU 300, and it has a display screen for displaying patient parameters. In this embodiment, the umbilical cable 160 is used for communicating patient parameters from the BMU 300 to the PRU 200.

A second aspect of the embodiment in fig. 41-57 is a drug delivery infusion pump device 220 in combination with a drug delivery cartridge device 251, which combination includes a drug delivery infusion pump housing 239, a drug delivery cartridge device 251, a pump housing door 201 and a pump housing door lock 205/222. The cartridge device 251 can be assigned to the infusion pump housing 239, has a cap 269 and a drug delivery cartridge main plate 253 with a cap base part 271. The cap 269 can be releasably attached to a cap base part 271. The pump housing door 201 is connected to the infusion pump housing 239 and has an open and closed position. The pump housing door lock 205/222 will, when the cassette device 201 is assigned to the infusion pump housing 239, release the pump housing door 201 when the cap 269 is to be placed in cap base part 271.

In an embodiment of the second aspect of the embodiment in fig. 41-57, the lock 205/222 includes a pump door lock 205 and a door lock solenoid 222 which is drive connected to the pump door lock 205. A person skilled in the art will know that there is the possibility of other embodiments. It should be mentioned that the pump housing door 201 can be opened to remove the cartridge device 251 when the cap 269 is returned to cap base part 271 at the conclusion of a medical procedure.

A third aspect of the embodiment in fig. 41-57 is a sedation delivery system procedure room unit 200 (or another type of medical effector system procedure room unit 200') that includes a capnometer 140 and 202 and a barcode reader 455. The capnometer 140 and 202 are designed to directly or indirectly receive breathing gas from a single patient -cannula 351' which can be placed on the face of a patient. The barcode reader 455 is designed for reading a barcode on a package containing the needle 351' and/or a barcode for the needle 351'.

An additional third aspect of the embodiment of FIG. 41-57 is a sedation delivery system procedure room unit 200 (or another type of medical effector system procedure room unit 200') having a drug delivery infusion pump housing 239 and a bar code reader 455. The drug delivery infusion pump housing 239 is designed to receive a drug delivery cartridge device 251 for single patient use. The barcode reader 455 is designed for reading a barcode on a package containing the drug delivery cartridge device 251 and/or a barcode for the drug delivery cartridge device 251.

According to a third aspect of the embodiment in fig. 41-57, the cartridge device 251 is designed to receive a drug vial 250 for single patient use and containing a drug (such as, without limitation, a sedating drug), and the barcode reader 455 is designed to read a barcode on the drug vial 250 and/or a barcode on a pack containing the drug vial 250.

In an embodiment of the third aspect, the additional third aspect and/or the additional third aspect of the embodiment in fig. 41-57, the procedure room unit 200 uses the barcode reader 455 to thereby prevent multiple use of an item intended for single patient use, such as the drug delivery cartridge device 251, the cannula 351' and the drug vial 250 in the procedure room unit 200. In another embodiment, the procedure room unit 200 uses the barcode reader 455 to adapt single patient- items for a particular patient. A person skilled in the art will be able to imagine other possible embodiments.

A fourth aspect of the embodiment in fig. 41-57 is a sedation delivery system 100 (or another type of medical effector system 100') that includes a microprocessor-based bedside monitoring unit 300, a microprocessor-based procedure room unit 200, and an umbilical cable 160. The bedside monitoring unit 300 has a first series of connection points for receiving patient input from patient monitoring connections, and also has a second series of patient output signal connections based on the received input signals, as well as a display screen for displaying at least some of the patient output values. The procedure room unit 200 has a drug delivery flow control device 220' (or another type of medical effector 220"), and a host controller 204 with a memory containing a patient monitoring and drug delivery program (or another type of a patient monitoring and medical effector program). The program is operatively connected with program inputs based at least in part on at least some of the patient output signals, and the program controls and/or provides instructions to a user for controlling the drug delivery flow control device 220' (or other type of medical effector 220'') based on at least partly on the program input signals. Umbilical cable one 160 has a first end connected or connectable to the second series of connection points in the bedside monitoring unit 300, and a second end which is connected or connectable to the procedure room unit 200.1 at least one of these ends of the umbilical cable 160 can be detached from the associated bedside monitoring unit 300 or the procedure room unit 200. The procedure room unit 200 includes an Ethernet and/or a modem connector 471/470 which is operatively connected to the host controller 204.

In an embodiment of the fourth aspect of the embodiment in fig. 41-57, the drug delivery control device 220' includes a drug delivery infusion pump device 220, such as a peristaltic pump device. In a variant of this embodiment, drug is delivered to the patient through an IV (intravenous). In another embodiment, not shown, the drug delivery flow control device may include a gas flow controller for a gaseous drug. In one variant, the gaseous medicament(s) may be oxygen and/or a non-oxygen gas which is delivered to the patient through a cannula device.

In an embodiment of the fourth aspect of the embodiment in fig. 41-57, the Ethernet and/or modem connector 471/470 is used for software remote updating of programs in memory in the host controller 204 in the procedure room unit 200, such as the patient monitoring and drug delivery program (or another type of patient monitoring and medical effector program). The term "memory" includes all the memories in the host controller 204, including, in an example, all the memories in the host controller's system input/output board 451 in the host controller and all the memory in the host controller's processor board 452. In the same or a different embodiment, the host controller 204 in the procedure room unit 200 may use Ethernet and /or modem connector 471/470 to send patient data to a remote computer for data processing. Professionals will be able to think of other possibilities. In one embodiment, the procedure room unit 200 has only an Ethernet connector 471 and no modem connector 470. In another embodiment, there is only a modem interface 470 and no Ethernet interface 471. In another embodiment, there is both an Ethernet and a modem interface 471 and 470.1 an embodiment of the fourth aspect of the embodiment in fig. 41-57, the procedure room unit 200 has a monitor screen 442 for displaying at least some of the program input signals and status of the drug delivery flow control device 220' (or other type of medical effector 220'').

A fifth aspect of the embodiment in fig. 41-57 is a sedation delivery system 100 (or another type of medical effector system 100') that includes a microprocessor-based bedside monitoring unit 300, a microprocessor-based procedure room unit 200, and an umbilical cable 160. The bedside monitoring unit 300 has a first series of connection points for receiving patient inputs from patient monitoring connections, and also has a second set of connections for sending patient output signals based on the received inputs, and the unit also has a display screen for displaying at least some of the patient output signals. The procedure room unit 200 has a drug delivery flow control device 220' (or another type of medical effector 220"), and a host controller 204 with a memory containing a patient monitoring and drug delivery program (or another type of a patient monitoring and medical effector program). The program is operatively connected with program inputs based at least in part on at least some of the patient output signals. The program controls and/or instructs a user to control or direct the drug delivery flow control device 220' (or other type of medical effector 220") based at least in part on the program inputs. The umbilical cable 160 has a first end connected or connectable to the second series of connection points in the bedside monitoring unit 300, and a second end connected or connectable to the procedure room unit 200. At least one of the umbilical cable's 160 ends is detachable from the bedside monitoring unit 300 or the procedure room unit 200. The host controller 204 in the procedure room unit 200 includes a "Health Level Seven application protocol" for electronically sending and/or receiving communications to and/or from a remote computer.

In an embodiment of the fifth aspect of the embodiment of FIG. 41-57, the "Health Level Seven application protocol" is used for electronic transmission of patient data to a remote computer for data processing purposes. In the same or a different embodiment, this protocol is used for electronic reception of remote control of (for example running diagnostic programs) the procedure room unit 200. Other applications will be conceivable to those skilled in the art.

A sixth aspect of the embodiment in fig. 41-57 is a sedation delivery system 100 (or another type of medical effector system 100') that includes a microprocessor-based bedside monitoring unit 300, a microprocessor-based procedure room unit 200, and an umbilical cable 160. The bedside monitoring unit 300 has a first array of connection points for receiving patient input values from patient monitoring connections, and also has a second series of connection points for providing patient output signals based on the received input signals, as well as a screen for displaying at least some of the patient output signals. The procedure room unit 200 has a drug delivery flow control device 220' (or another type of medical effector 220") and a host controller 204 with a memory containing a patient monitoring and drug delivery program (or another type of patient monitoring and drug effector program). The program is operatively connected to program -inputs based at least in part on at least some of the patient output signals. The program controls and/or instructs a user to control the drug delivery flow control device 220' (or other type of end effector 220") based at least in part on the program inputs. The umbilical cable 160 has a first end connected or connectable to a second series of connection points in the bedside monitoring unit 300 and a second end connected or connectable to the procedure room unit 200.1 at least one of the first and second ends of the umbilical cable 160 is detachable from the corresponding bedside monitoring unit 300 or the procedure room unit 200. The procedure room unit 200 includes a printer 454 operatively connected to the host controller 204.

In an embodiment of the sixth aspect of the embodiment in fig. 41-57, the printer 454 is used to provide a printed patient record for the sedation delivery system 100 (or another type of medical effector system 100') during the medical procedure the patient is undergoing. In an example of the sixth aspect of the embodiment of FIG. 36-52, the procedure room unit 200 has a procedure room unit console 444, which console 444 includes the drug delivery flow control device 220' (or other type of medical effector 220'), the host controller 204, and the printer 454. In one embodiment, the printer 454 is a thermal printer.

A seventh aspect of the embodiment of FIG. 41-57 is a sedation delivery system 100 that includes a microprocessor-based bedside monitoring unit 300, a microprocessor-based procedure room unit 200, and an umbilical cable 160. The bedside monitoring unit 300 has a bedside monitoring unit host controller 301 (see FIG. 62) containing a first program. This first program performs the following steps: issuing a request to an unsedated patient for an unsedated patient response; receiving a signal based on the response of the non-sedated patient; and calculating a non-sedated response time for the patient, based at least in part on a time difference between issuing the request and receiving the signal. The procedure room unit 200 has a procedure room unit host controller 204, which contains a second program. This second program performs the following steps: issuing a request or demand via the bedside monitoring unit 300 to a sedated patient for a sedated patient response; receiving a signal via the bedside monitoring unit 300 based on the response of the sedated patient; calculation of a sedated response time for the sedated patient, and calculation of a response time difference between the non-sedated and sedated response times. The umbilical cable 160 has a first end connected or connectable to the bedside monitoring unit 300 and a second end connected or connectable to the procedure room unit 200. At least one of these first and second ends is detachable from the corresponding bedside monitoring unit 300 or procedure room unit 200.

In an example of the seventh aspect of the embodiment in fig. 41-57, the procedure room unit 200 has a drug delivery infusion pump device 220. The drug delivery infusion pump device 220 is controlled by the procedure room unit host controller 204, based at least in part on the response time difference. In the same or another example, a sedation delivery system 100 includes a cannula device 145 that can be placed on the face of a patient and that has breathing gas sampling tubes 354, 352 and 355 (see FIG. 1). The breathing gas sampling tube 354, 352 and 355 (see FIG. 1) can be connected to the bedside monitoring unit 300. The procedure room unit 200 includes a capnometer 202 and 140 which provides a capnometer output signal, and the umbilical cable 160 is operatively connectable to the breathing gas sampling tube 354, 352 and 355 and the capnometer 202 and 140. The drug delivery infusion pump device 220 is controlled at least in part with the capnometer output signal et.

In an embodiment of the seventh aspect of the embodiment in fig. 41-57, the bedside monitoring unit 300 includes an audio earplug 362 (see FIG. 1) to thereby send the patient 10 requests to squeeze an automatic response monitor (ARM) handset 342 (eg, a hand-held device that may include a vibrator for elicitation of a response from the patient) for calculating the patient response time. The requests are sent from the bedside monitoring unit 300 in a pre-procedure room to train the unsedated patient to use the ARM handset 342 and to calculate the unsedated response time. The requests are sent from the procedure room unit 200 (and transmitted to the bedside monitoring unit 300 through the umbilical cable 160) when the patient is subjected to sedation in the procedure room, in order to thereby be able to calculate the sedated response time during the procedure. The requests are sent from the bedside monitoring unit 300 in a post-procedure room to present YES/NO questions, multiple choice questions, timed response questions, or other such prompt response interactions, and combine the responses with other monitored parameters to thereby determine the patient's condition. An example would be a series of questions/activities for the detection of cognitive functions and motor functions before the patient is discharged. Another example would be to monitor the response level and notify the medical staff if the patient does not reach certain defined threshold values within a suitable time period.

Another example would be to use the ARM handset 342 instead of a call key. When the patients are in the pre-procedure or post-procedure room, a long squeeze or quick squeezes of the ARM handset 342 will be detected in the BMU 300, as a request for assistance. The BMU 300 will then log the request, send it to the BMU GUI 212 (see Fig. 60) and illuminate the light element 208 (see Fig. 60) in the form of a suitable color or flare.

Another example is that the BMU 300 detects a low breathing rate, an apneic state or low SpC>2 and communicates this status to the patient. The BMU 300 will send an audio request, such as "BREATHE DEEPLY" to the patient via the audio earplug 362, so that the patient is thereby instructed to breathe deeply. The order can be repeated at predetermined time intervals if the patient's breathing rate does not increase. Furthermore, the order can initially be placed with a first nominal volume level, with subsequent orders being delivered with a second volume level that is higher than the first volume level. If the patient does not respond to the request for breathing, an alarm will notify the healthcare staff of the patient's condition. Other similar types of voice commands can be given to the patient when other conditions require a special patient response.

An eighth aspect of the embodiment of FIG. 41-57 is a sedation delivery system procedure room unit 200 (or other type of medical effector system procedure room unit 200') that includes a procedure room unit host controller 204 having an oxygen delivery program that performs the steps of: receiving a pulse oximeter signal from a subject patient sedating, and calculating an oxygen flow rate based at least in part on the received pulse oximeter signal, the procedure room host controller 204 directing a flow of oxygen to the patient based on the calculated oxygen flow rate.

In the eighth aspect of the embodiment of FIG. 41-57 is the oxygen flow rate to

patient variable and is based at least in part on patient blood oxygen levels from the received pulse oximeter signal. It should be mentioned here that the term "oxygen", when it concerns oxygen delivery, also includes air which has an enriched oxygen content.

A first embodiment of the eighth aspect of the embodiment in fig. 41-57 is a sedation delivery system 100 (or another type of medical effector system 100') that includes the sedation delivery system procedure room unit 200 (or another type of medical effector system procedure room unit 200') as described in the preceding paragraph, with a bedside monitoring unit 300 and with an umbilical cable 160 The umbilical cable 160 has a first end connected or connectable to the bedside monitoring unit 300 and a second end connected or connectable to the procedure room unit 200. At least one of the first and second ends is detachable from the corresponding bedside monitoring unit 300 or procedure room unit 200. When the umbilical cable 160 is connected to the procedure room unit 200 and the bedside monitoring unit 300, a pulse oximeter signal will pass from the patient via the bedside monitoring unit 300 and through the umbilical cable 160 to the procedure room unit 200, while the flow of oxygen goes through the umbilical cable 160 and the bedside monitoring unit 300 and ten l the patient.

A ninth aspect of the embodiment of FIG. 41-57 is a medical oxygen delivery device that includes an oxygen delivery manifold 206 with an oxygen delivery flow path, a flow restrictor 489 with a nozzle of a fixed size, and a flow restrictor 480 with a nozzle whose size can be varied. The oxygen delivery flow path includes a flow path inlet that is fluidly connectable to a pressurized oxygen source, and a flow path outlet that is fluidly connectable to a cannula 351 that can be placed on the face of a patient. The flow restrictor 489 with the fixed nozzle is arranged in the flow path downstream of the flow path inlet, and the flow restrictor 480 with the variable nozzle is arranged in the flow path downstream of the flow restrictor 489 having the fixed nozzle.

In an example of the ninth aspect of the embodiment of FIG. 41-57, the medical oxygen delivery device also includes a high side pressure sensor 487 in fluid communication with the flow path at a first location between the flow path inlet and the fixed flow restrictor 489, as well as a differential pressure sensor 479 in fluid communication with the flow path at an entry location arranged between the first mentioned location and the fixed flow restrictor 489 and an exit point arranged between the fixed flow restrictor 489 and the variable flow restrictor 480. The nozzle opening in the variable flow restrictor 480 relates to measured pressure and pressure difference and is used to control the amount of flow in a manner that will be known to those skilled in the art. In the same or another example, the variable flow restrictor 480 may be a solenoid with a variable nozzle opening. In one application, the oxygen delivery manifold 206 is a sub-device in a procedure room unit 200 of a sedation delivery system 100 (or another type of medical effector system 100').

A tenth aspect of the embodiment of FIG. 41-57 is a sedation delivery system procedure room unit 200 (or other medical effector system procedure room unit 200') with a procedure room unit host controller 204 containing an oxygen delivery program. The program carries out the steps of: controlling the delivery of oxygen in a predetermined first amount to at least one oral breathing gas delivery branch 369"/371" in a cannula device 145 operatively connected to a patient, when the patient is to breathe in and out through the mouth; controlling the delivery of oxygen in a predetermined second amount to at least one nasal breathing gas delivery branch 422' and 422" of the cannula device 145 when the patient is to breathe through the nose and when the patient is to inhale; and controlling the delivery of oxygen in a predetermined third amount to the at least one nasal breathing gas delivery branch 422' or 422" when the patient is to breathe through the nose and when the patient is to exhale. The second breath volume is higher than the third breath volume.

In an example of the tenth aspect of the embodiment of FIG. 41-57, when oxygen flows, oxygen will always flow to all oral and nasal breathing gas delivery branches when the amount of oxygen is controlled to either the oral or nasal breathing gas delivery branch.

In an embodiment of the tenth aspect of the embodiment of FIG. 41-57 the oxygen delivery program will also determine whether the patient should breathe through the nose or the mouth. If the patient is to breathe through the nose, inhalation or exhalation takes place based at least in part on nasal pressure measurements of the sampled breathing gas taken from at least one nasal breathing gas sampling branch 364 and 365 in the cannula device 145.

A first alternative tenth aspect of the embodiment in fig. 41-57 is a medical effector system procedure room unit 200' (such as a sedation delivery system procedure room unit 200') that includes a procedure room unit host controller 204 containing an oxygen delivery program. The program carries out the steps of: controlling the delivery of oxygen in a variable first amount to at least one oral breathing gas delivery branch 369"/371" in a cannula device 145 operatively connected to a patient, when the patient is to breathe in and out through the mouth; controlling the delivery of oxygen in a variable second amount to at least one nasal breathing gas delivery branch 422' and 422" of the cannula device 145, when the patient is to breathe through the nose and when the patient is to inhale; and controlling the delivery of oxygen in a variable third amount to the at least one nasal breathing gas delivery branch 422' and 422", when the patient is to breathe through the nose and the patient is to exhale. The patient will receive a variable blood oxygen saturation percentage, and the first, second and third amounts will depend on the blood oxygen saturation percentage.

In an embodiment of the first alternative tenth aspect of the embodiment in FIG. 41-57, the second amount will be a fixed low amount for blood oxygen saturation percentages above a predetermined high percentage value and will be a fixed high amount for blood oxygen saturation percentages that are below a predetermined low percentage value. In one variant, the second amount increases several times from the fixed low amount up to the fixed high amount as the blood oxygen saturation percentage decreases from the predetermined high percentage value to the predetermined low percentage value. In a modification, the second amount may be higher than the third amount for the same blood oxygen saturation percentage. In one implementation, the third quantity may be zero at the predetermined high percentage value. In the same or another embodiment, the first amount corresponding to a particular blood oxygen saturation percentage may be the arithmetic mean of the second and third amounts corresponding to the particular blood oxygen saturation percentage. In the same or another embodiment, the oxygen delivery program may accept a user input for raising, but never lowering, the second amount above the fixed low amount when the blood oxygen saturation percentage is above, but never below, the predetermined high percentage value. In one variation, the oxygen delivery program may accept a user input for raising, but never lowering, the third amount when the blood oxygen saturation percentage is above, but never below, the predetermined high percentage value.

In an example of the first alternative tenth aspect of the embodiment of FIG. 41-57 it will

the second quantity should be mainly 2 liters per minute, while the third amount is 0 liters per minute for a predetermined high percentage value of mainly 96%. The other amount will be mainly 15 liters per minute, while the third amount will be mainly 2 liters per minute for a predetermined low percentage value of mainly 84%. In this example, the second quantity is essentially 8 liters per minute, while the third quantity is mainly 2 liters per minute when the blood oxygen saturation percentage is mainly between 88% and 96%, and the other amount will be mainly 12 liters per minute, while the third quantity is mainly 2 liters per minute when the blood oxygen saturation percentage is mainly between 84% and 88%. Advantages of this example include basing the oxygen delivery amount on the patient's oxygen saturation level, which would provide a higher oxygen delivery amount for a patient who has a low blood oxygen saturation but a lower oxygen delivery amount

for a patient who has a high blood oxygen measurement, thereby saving oxygen. In this example, the flow rates may be for a patient who has a predominant nasal breathing. If the patient has a predominant oral breathing (indicated by the absence of a nasal pressure signal), then the flow rate can be the arithmetic mean of

inhalation and exhalation amounts for the individual blood oxygen segment.

A second alternative tenth aspect of the embodiment in fig. 41-57 is a medical effector system procedure room unit 200' (such as a sedation delivery system procedure room unit 200) that includes a procedure room unit host controller 204 containing an oxygen delivery program. The program carries out the steps of: controlling the oxygen delivery with a variable nasal oxygen delivery flow rate to at least one nasal breathing gas delivery branch 422' and 422" in a cannula device 145 operatively connected to a patient, when the patient is to breathe through the nose and when the patient is to inhale; and controlling the oxygen delivery with a nasal oxygen delivery flow rate to the at least one nasal breathing gas delivery branches 422' and 422' when the patient is to breathe through the nose and when the patient is to exhale. The patient has a varying blood oxygen saturation percentage, and the nasal oxygen delivery inhalation amount will be a variable amount, depending on the blood oxygen saturation percentage.

In an embodiment of the second alternative tenth aspect of the embodiment in fig. 41-57, the nasal exhalation oxygen delivery amount is a variable amount, which will depend on the blood oxygen saturation percentage, and the nasal inhalation oxygen delivery amount will be greater than the nasal exhalation oxygen delivery amount for the same blood oxygen saturation percentage.

An eleventh aspect of the embodiment of FIG. 41-57 is a medical oxygen delivery device having an oxygen delivery manifold 206. The oxygen delivery manifold 206 has an oxygen delivery flow path and an oxygen sampling flow path fluidly connectable to the oxygen delivery flow path. The oxygen delivery flow path includes a flow path inlet that is fluidly connectable to a pressurized oxygen source and a flow path outlet that is fluidly connectable to a cannula 351' that can be placed on the face of a patient. The oxygen sampling flow path includes an oxygen sensor 482, which detects hypoxic gas.

In an embodiment of the eleventh aspect of the embodiment in fig. 41-57, an oxygen sampling solenoid 481 connects the oxygen sampling flow path to the oxygen delivery flow path. In one implementation, a detection of hypoxic (low oxygen) gas is used with the oxygen sensor 482 to provide a user alarm for checking the oxygen source. In one embodiment, the oxygen delivery manifold 206 is a sub-device in a procedure room unit 200 in a sedation delivery system 100 (Or another type of medical effector system 100').

A twelfth aspect of the embodiment of FIG. 41-57 is a sedation delivery system procedure room unit 200 (or another type of medical effector system procedure room unit 200') that includes a procedure room unit host controller 204 and a capnometer 140 and 202. The capnometer 140 and 202 have a capnometer gas inlet that directly or indirectly receives breathing gas from a needle 351' which can be arranged on the face of a patient. The capnometers 140 and 202 also have a capnometer signal output operatively connected to the procedure room unit host controller 204. The procedure room unit host controller 204 sends a user alarm that the capnometers 140 and 202 are in fluid communication with the cannula 351', based at least in part on the capnometer the signal output of the capnometer 140 and 202.

In an embodiment of the twelfth aspect of the embodiment in fig. 41-57, the capnometer input receives indirect breathing gas from the cannula 351' via a bedside monitoring unit 300. The bedside monitoring unit 300 can be connected to the cannula 351' and is connected or can be connected to a first end of an umbilical cable 160. The umbilical cable 160 has a second end attached or connectable to the procedure room unit 200.1 at least one of these first and second ends is detachable from the corresponding bedside monitoring unit 300 or the procedure room unit 200. Typically, in this example, a detached umbilical cable 160 will be the one that provides the majority of user alarms from the procedure room unit host controller 204 with the message that the capnometer 140 and 202 do not have a fluid connection with the cannula 351'. In one embodiment, it is the procedure room unit host controller 204 that determines whether the capnometers 140 and 202 are fluidly connected to the cannula 351' when the capnometer output indicates a valid or valid breathing rate for the patient, based on a rise and fall in the capnometer output (i.e., a rise and fall of the carbon dioxide level measured by the capnometer 140 and 202).

A thirteenth aspect of the embodiment of FIG. 41-57 is a sedation delivery system procedure room unit 200 (or another type of medical effector system procedure room unit 200') that includes a sedation delivery system procedure room unit console 444 (or another type of medical effector system procedure room unit console 444') with a console fan 456 and a capnometer subdevice 140/202 and 141/142. The console fan 456 directs air into, through and out of the procedure room unit console 44 (or 444'). The capnometer subassembly 140/202 and 141/142 have a capnometer subassembly gas inlet and a capnometer subassembly gas outlet. The capnometer subassembly gas outlet is arranged to allow gas leaving the capnometer subassembly gas outlet to be captured with air moved by the console fan 456 .

In an example of the thirteenth aspect of the embodiment of FIG. 41-57, the capnometer subassembly 140/202 and 141/142 has a capnometer 140 and 202 and a capnometer pump 141 and 142 which are operatively connected to the capnometer 140 and 202.1 embodiment of this example gas flows from the capnometer subassembly gas inlet to the capnometer, the capnometer pump and to the capnometer subdevice gas outlet. In another embodiment of this example, gas flows from the capnometer subdevice gas inlet to the capnometer pump, to the capnometer, and to the capnometer subdevice gas outlet. An advantage of the fact that gas from the capnometer subdevice gas outlet can be fan ventilated outside the console using the console fan is that such outlet gas has a lower probability of contaminating the capnometer calibration. In one arrangement, calibration gas and console fan air are drawn in from the front of the console and exit from the rear of the console.

In a variant of the thirteenth aspect of the embodiment in fig. 41-57, a sedation delivery system 100 (or another type of medical effector system 100') includes a sedation delivery system-procedure room unit 200 (or another type of medical effector system-procedure room unit 200'), as described in the penultimate preceding paragraph, a bedside monitoring unit 300 and a umbilical cable 160. The umbilical cable 160 has a first end connected or connectable to the bedside monitoring unit 300 and a second end connected or connectable to the procedure room unit 200.1 at least one of these first and second ends is detachable from the corresponding bedside monitoring unit 300 or procedure room unit 200.

A fourteenth aspect of the embodiment of FIG. 41-57 is a sedation delivery system procedure room unit 200 (or other type of medical effector system procedure room unit 200') with a procedure room unit host controller 204, a capnometer 140 and 202, an oxygen manifold 206 and a low side pressure sensor 488. The capnometer 140 and 202 have a capnometer- gas inlet that directly or indirectly receives breathing gas from a cannula 351' that can be placed on the face of a patient. Furthermore, the capnometer has a capnometer signal output that is operatively connected to the procedure room unit host controller 204. The oxygen manifold 206 has an oxygen delivery flow path with a flow path inlet that is fluidly connected to a source of pressurized oxygen, a flow restrictor 489 and 480 and a flow path outlet that is fluidly connectable with the cannula 351'. The low side pressure sensor 488 is in fluid communication with the flow path outlet and is located downstream of the oxygen manifold flow restrictors 489 and 480. The sensor also has a low side pressure signal output that is operatively connected to the procedure room unit host controller 204. The procedure room unit host controller 204 sends a user alarm regarding whether the capnometer 140 and 202 are fluidly connected and/or not fluidly connected to the cannula 351', based at least in part on the capnometer signal output from the capnometer 140 and 202 and the low side pressure signal output from the low side pressure sensor 488.

In an example of the fourteenth aspect of the embodiment of FIG. 41-57, the capnometer input receives indirect breathing gas from the cannula 351' via a bedside monitoring unit 300 that is connectable to the cannula 351' and is connected or connectable to a first end of an umbilical cable 160, which has a second end connected or connectable to the procedure room unit 200. The flow path outlet of the oxygen manifold 206 is indirectly fluid-connected to the cannula 351' via the bedside monitoring unit 300 and the umbilical cable 160. At least one of the two ends is detachable from the corresponding bedside monitoring unit 300 or procedure room unit 200.

A fifteenth aspect of the embodiment of FIG. 41-57 is a sedation delivery system procedure room unit 200 (or another type of medical effector system procedure room unit 200') having a procedure room unit host controller 204, a capnometer 140 and 202 and a capnometer pump 141 and 142. The capnometer 140 and 202 have a capnometer gas inlet which directly or indirectly receives breathing gas from a cannula 351' which can be placed on the face of a patient. The capnometer 140 and 202 also have a capnometer signal output operatively connected to the procedure room unit host controller 204. The capnometer pump 141 and 142 are operatively connected to the capnometer 140 and 202 and controlled by the procedure room unit host controller 204. The procedure room unit host controller 204 determines whether the capnometer 140 and 202 is fluidly connected or not fluidly connected to the cannula 351', based at least in part on the capnometer signal output from the capnometer 140 and 202. The procedure room unit host controller 204 shuts off the capnometer pump 141 and 142, with or without a time delay, when the capnometer 140 and 202 are not fluidly connected to the cannula 351'. In one embodiment, shutting off the capnometer pump 141 and 142 when the cannula 351' is not in use will prevent pollutants, impurities etc. in the air from contaminating the capnometer 140 and 202 at such times.

In an example of the fifteenth aspect of the embodiment of FIG. 41-57, the capnometer input receives indirect breathing gas from the cannula 351' via a bedside monitoring unit 300. The bedside monitoring unit 300 is connectable to the cannula 351' and is connected or connectable to a first end of an umbilical cable 160. The umbilical cable 160 has a second end connected or connectable to the procedure room unit 200.1 at least one of the first and second ends is detachable from the corresponding bedside monitoring unit 300 or the procedure room unit 200.

A sixteenth aspect of the embodiment of FIG. 41-57 is a sedation delivery system procedure room unit 200 (or another type of medical effector system procedure room unit 200') having a procedure room unit host controller 204, a capnometer 140 and 202, and an ambient air pressure sensor 46. The capnometer 140 and 202 have a capnometer gas inlet that directly or indirectly receives breathing gas from a cannula 351 that can be placed on a patient's face. The capnometers 140 and 202 have a capnometer signal output operatively connected to the procedure room unit host controller 204. The ambient air pressure sensor 35 has a signal output operatively connected to the procedure room unit host controller 204. The procedure room unit host controller 204 determines whether the sedation delivery system procedure room unit 200 (or a other type of medical effector system procedure room unit 200') has been moved to a new location with an elevation difference greater than a predetermined elevation difference using at least the signal output from the ambient air pressure sensor 46. The procedure room unit host controller 204 sends a capnometer calibration user alarm if the sedation delivery system procedure room unit 200 (or another type of medical effector system procedure room unit 200') has been moved to a new location that has an elevation difference greater than the predetermined elevation difference.

In an example of the sixteenth aspect of the embodiment of FIG. 41-57, the capnometer input receives indirect breathing gas from the cannula 351' via a bedside monitoring unit 300. The bedside monitoring unit 300 is connectable to the cannula 351' and is connected or connectable to a first end of an umbilical cable 160. The umbilical cable 160 has a second end which is connected or connectable to the procedure room unit 200.1 at least one of the first and second ends is detachable from the corresponding bedside monitoring unit 300 or the procedure room unit 200.

A seventeenth aspect of the embodiment of FIG. 41-57 is a sedation delivery system procedure room unit 200 (or another type of medical effector system procedure room unit 200') having a procedure room unit host controller 204, a cannula 351' and an oxygen manifold 206. The cannula 351' can be placed on the face of a patient and has a breathing gas sample outlet operatively connectable to the procedure room unit host controller 204. The oxygen manifold 206 has a flow path outlet fluidly connectable to the cannula 351' and has a variable nozzle size flow restrictor 480 operatively connected to and disposed upstream of the flow path outlet. The procedure room unit host controller 204 determines whether the patient is breathing with a deployed cannula 351', based at least on the breath gas sample output from the cannula 351', and will open the flow restrictor 480 with the variable nozzle opening when it is determined that the patient is breathing with a deployed cannula 351' .

In one embodiment of the seventeenth aspect of the embodiment of FIG. 41-57, the breathing gas sample outlet in the cannula 351' is operatively connected to the procedure room unit host controller 204 via a pressure transducer (such as a nasal pressure transducer 47) and/or through a capnometer 140 and 202. In the same or a different embodiment, the variable flow restrictor 480 is a solenoid with a variable nozzle size.

In an application of some of the previously described aspects of fig. 41-57, examples etc. included, the procedure room unit 200 is directly connectable to a bedside monitoring unit 300. Those skilled in the art will appreciate that there are other possible applications.

One or more of the previously described aspects of the embodiment in fig. 41-57, including examples etc, can be combined with one or more of the previously described aspects of the embodiment in fig. 41-57, including examples etc., as will be clear to a person skilled in the art.

In an alternative embodiment, shown in fig. 58, a procedure room unit 50 includes an energy delivering medical effector 52. One aspect of the embodiment of FIG. 58 is a medical effector system 54 that includes a microprocessor-based bedside monitoring unit 56, a microprocessor-based procedure room unit 50, and an umbilical cable 58. The bedside monitoring unit 56 has a first array of connections 60 for receiving patient inputs from patient monitoring connections, and also has a second array of connections 62 for delivering patient outputs based on the received inputs, as well as a display screen 64 for displaying at least some of the patient outputs. The procedure room unit 50 has an energizing medical effector 52 and a host controller 66 with a memory containing a patient monitoring and medical effector program operatively connected to program inputs based at least in part on at least some of the patient outputs, and which controls and/or instructs a user to control the energizing medical effector 52, based at least in part on the program inputs. The umbilical cable 58 has a first end connected or connectable to the second row of connection points 62 in the bedside monitoring unit 56 and has a second end which is connected or connectable to the procedure room unit 50.1 at least one of these first and second ends is detachable from the corresponding bedside monitoring unit 56 or the procedure room unit 50.1 an example, the energy-supplying medical effector 52 includes at least one magnetic flux generator 68 designed to deliver a time-variable magnetic field to a patient in order to thereby give the patient a sedating effect. In one variant, the at least one magnetic flux generator 68 includes a winding 70.

Fig. 59 shows an embodiment of a medical effector subsystem 306. A first aspect of the embodiment in Fig. 59 is a medical effector subsystem 306 that includes a drug delivery tube 308, a pressure sensor 324 and a memory 326. The drug delivery tube 308 is designed to carry a drug 328 with a variable ordered flow rate that can be delivered to a patient 336. The pressure sensor 324 has an output signal 338 and is designed for detecting the internal pressure in the drug delivery tube 308. The memory 326 contains an occlusion program which, run on a processor 344, will be operatively connected to the output signal 338 of the pressure sensor 324. The occlusion program has a variable pressure alarm setting and sends an alarm to a user of an occluded drug delivery tube 308 when the pressure sensor 324 output signal 338 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 drug 328 .

The term "occluded" includes both partially occluded and completely occluded. Causes of an occluded drug delivery tube 308 include a bend, a twist, a pinch and/or a blocked tube. In one embodiment of the first aspect of the embodiment in FIG. 59, the drug 328 is a pumped drug, which is pumped at the variable commanded flow rate. When the drug delivery tube 308 is occluded, continued pumping of the drug 328 will cause the pressure in the drug delivery tube 308 to increase. It should be mentioned that a change of the variable pressure alarm setting based on an order or an actual pump speed will be a change of the variable pressure alarm setting based indirectly on the variable ordered flow amount of drug. A person skilled in the art will understand this. In one arrangement, because increasing the amount of drug will increase the pressure in a non-occluded tube or tube, the variable pressure alarm setting will always be set to be higher (eg by a predetermined amount) than the pressure in a non-occluded tube corresponding to the current commanded flow rate (or equivalent to the current commanded or actual pump speed).

In an implementation of the first aspect in the embodiment of FIG. 59, the occlusion program will set the variable pressure alarm setting to a fixed low level when the variable command flow rate is below a predetermined value, and will set the variable pressure alarm setting to a fixed higher value when the variable command flow rate is at or above the predetermined value. In another implementation, the occlusion program will change the variable pressure alarm setting when there is a change in the variable commanded flow rate. Those skilled in the art will be able to envision other implementations.

In one embodiment of the first aspect of the embodiment in FIG. 59, the drug delivery tube 308 is an intravenous drug delivery tube. In another embodiment, not shown, the drug delivery tube can be a pneumatic tube, the drug being then a gaseous drug. As mentioned above, oxygen (ie air with increased oxygen content) is an example of a gaseous drug.

In one embodiment of the first aspect of the embodiment in FIG. 59, the pressure sensor 324 has a pressure-sensitive input part 346, and the drug delivery tube 308 has an outer surface part 348.1 such an embodiment the pressure sensor 324's input part 346 contacts the drug delivery tube 308's tight outer surface part 348. Those skilled in the art will be able to imagine other pressure sensor and/or drug delivery tube types and designs, including for example a pressure sensor input which has a fluid connection with the drug in the drug delivery tube.

In one embodiment of the first aspect of the embodiment in FIG. 59, the memory 326 and the processor 344 are components of a host controller in a procedure room unit (such as a host controller 204 in the procedure room unit 200 described above). In one variant, the memory 326 also contains a drug delivery algorithm, such as the previously mentioned dosage control (DC) algorithm, which when executed in the processor 344, will determine the variable ordered 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. Those skilled in the art will be able to imagine other modifications, variants and designs.

In an application of the first aspect of the embodiment of FIG. 59, the medical effector subsystem 306 also includes an infusion pump 350, designed to take the variable commanded flow rate. The infusion pump 350 has peristaltic pump fingers 372. The peristaltic pump fingers 372 are arranged to cooperate with the drug delivery tube 308 and can be controlled to pump the drug 328 at the variable commanded flow rate.

A second aspect of the embodiment in fig. 59 is a medical effector subsystem 306 that includes a drug delivery tube 308, a pressure sensor 324 and a memory 326. The drug delivery tube 308 is designed to carry a drug 328 with a variable ordered flow rate for delivery of the drug 328 to a patient 336, and the tube has a sealed outer surface portion 348. The pressure sensor 324 has an output signal 338 and includes a pressure sensitive input portion 346 disposed in contact with the sealed outer surface portion 348 of the drug delivery tube 308. The memory 326 contains an occlusion program which, when executed on a processor 344, will be operatively connected to the pressure sensor 324 output signal 338. The occlusion program has a variable pressure alarm setting and sends an alarm to a user about an occluded drug delivery tube 308 when the output signal 338 from the pressure sensor 324 exceeds the variable pressure alarm setting. The occlusion program changes the variable pressure alarm setting based entirely and directly on the variable commanded flow rate of drug 328.

A third aspect of the embodiment in fig. 59 is a medical effector subsystem 306 that has a drug delivery tube 308, a pressure sensor 324, and an occlusion alarm unit 380. The drug delivery tube 308 is designed to carry a drug 328 at a variable commanded flow rate and to deliver the drug 328 to a patient 336. The pressure sensor 324 has an output signal 338 and is designed for sensing the pressure in the drug delivery tube 308. The occlusion alarm unit 380 is operatively connected to the pressure sensor 324 output signal 338 and has a variable pressure alarm setting for notifying a user of an occluded drug delivery tube 308 when the pressure sensor 324 output signal 338 exceeds the variable pressure alarm setting. The occlusion alarm unit 380 changes the variable pressure alarm setting based at least in part, and directly or indirectly, on the variable ordered flow rate of drug 328. In one example, the occlusion alarm unit 380 includes the previously described memory 326 and processor 344 in a procedure room unit host controller (such as the previous described host controller 204) and notifies the user by means of a window that appears on a monitor (such as a procedure room unit monitor 44) as shown in FIG. 48). In another example, not shown, the occlusion alarm unit does not involve a processor in a procedure room unit host controller.

A fourth aspect of the embodiment in fig. 59 is a drug delivery infusion pump subassembly 382 that includes a drug delivery tube 308, peristaltic pump fingers 372, a pressure sensor 324, and an occlusion alarm unit 380. The drug delivery tube 308 is designed to guide a drug 328 and deliver the drug 328 to a patient 336. The peristaltic pump fingers 372 are arranged to cooperate with the drug delivery tube 308 and can be controlled to pump the drug 328 at a commanded flow rate. The pressure sensor 324 has an output signal 338 and is designed to sense the pressure in the drug delivery tube 308 downstream of the peristaltic pump fingers 372. The occlusion alarm unit 380 is operatively connected to the output signal 338 of the pressure sensor 324 and has a variable pressure alarm setting for notifying a user of an occluded drug delivery tube 308 when the pressure sensor's 324 output signal 338 exceeds the variable pressure alarm setting. The occlusion alarm unit 380 changes the variable pressure alarm setting completely and directly based on the variable commanded flow rate of drug.

In an implementation of the fourth aspect of the embodiment of FIG. 59, the drug delivery tube 308, the peristaltic pump fingers 372, the pressure sensor 324, and the occlusion alarm unit 380 are components of a procedure room unit of a medical effector system (such as the procedure room unit 200 of the above-described medical effector system 100'). In an example of the fourth aspect of the embodiment of FIG. 59, the occlusion alarm unit 380 includes the previously described memory 326 and the processor 344, and alerts the user by means of a window and/or a flashing visual alarm on a monitor (such as a procedure room unit monitor 441, as shown in FIG. 48) and/or using a noise alarm. In another example, not shown, the occlusion alarm unit does not involve a processor in a procedure room unit host controller and therefore operates independently of, and in the absence of, the previously described procedure room unit 200.

It should be mentioned that implementations, executions, constructions etc. of the first aspect of the embodiment in fig. 59 are also applicable to one or more or all of the second to fourth aspects of the embodiment in fig. 59.1 an example of one or more or all of the aspects of the embodiment in fig. 59, the patient 336 receiving the drug 328 will be better controlled when the occlusion pressure alarm setting is changed based on the variable commanded flow rate of drug 328. The better control or management is achieved because the response time to an occlusion, and any bolus buildup, will be minimized compared to using a conventional fixed and very high occlusion pressure alarm setting for all ordered flow rates of the drug. It should also be noted that such a conventional alarm setting must be higher than that corresponding to the highest actual flow rate of the drug (which is least used) because the pressure in the non-occluded drug delivery tubing will increase with increased actual flow rates of the drug, as those skilled in the art will appreciate. . It should further be noted that with such a high conventional and fixed alarm setting, it will take much longer for a low commanded flow rate to generate sufficient pressure in the occluded drug delivery tubing to provide an occlusion alarm, and when such a high internal pressure is released, a greater bolus (body) of drug is sent to the patient.

The following paragraphs present a more detailed description of a particular embodiment of the embodiment in fig. 41-57. It should be mentioned that one or all features of this particular embodiment can be used in all the previously described aspects (including examples etc.) of the embodiment in fig. 41-57.1 this particular embodiment, the PRU 200 is the main interface between the SDS 100 and the healthcare personnel responsible for administering the drug or drugs. The PRU 200 is designed for use in the procedure room. The PRU 200 connects to the BMU 300 by means of an umbilical cable 160. The PRU 200 receives all physiological signals provided by the BMU 300 as well as from the nasal capnometer module 140 and the oral capnometer module 202 which are provided in the PRU 200. The PRU 200 receives user- input parameters such as patient data, drug dose rate targets and alarm trigger settings. The PRU 200 processes these physiological signals and user input parameters, displays the physiological signals, derivatives of these signals and related alarm status for user observation, and performs drug delivery and oxygen measurement in accordance with algorithms driven by these signals.

The dose controller (DC) is a drug delivery algorithm used by the PRU 200 and is an augmentation of the dose rate control (DRC). The enhancement includes the algorithm's ability to calculate the appropriate delivery dose, which is based on drug guidelines. For a given maintenance amount, DC calculates a suitable delivery dose that enables the rapid achievement of the sedation effect at the beginning of the medical procedure.

The PRU 200 includes interactive software, the monitoring shell, which monitors and displays the patient's condition and makes decisions regarding the patient's status and the resulting drug delivery. The monitoring shell uses algorithms for quantifying the patient's status, controls the drug delivery amount and the oxygen delivery amount, and sends alarms to the user. The monitoring shell uses a wide range of input parameters such as DC data, patient physiological monitoring data, patient physical data and alarm trigger settings. The monitoring shell reduces or stops drug delivery, along with a notification to the user, if it detects certain undesirable sedation conditions for the patient. It will start drug delivery again when such undesirable sedation conditions are corrected. The amount of medication is based on user input parameters, such as recommended dose amount and patient weight, and software-based decisions in accordance with applied pharmacological principles. The oxygen delivery amount is based on user input parameters and patient monitoring data such as an oxygen saturation level.

The PRU 200 includes an intuitive display presentation called the PRU Graphical User Interface (PRU GUT) 210. The PRU GUI 210 displays the patient's status in terms of physiological parameters and alarms/notifications. It also shows the functional status of internal sensors and drive data. The PRU GUI 210 thus represents a simple, intuitive means for the user to input parameters such as patient data, drug dose amount and alarm trigger levels. A detail of the PRU GUI 210 is the intelligent PRU alarm box 249 which enables the user to quickly ascertain the general condition of the patient using the colors green, yellow and red. The intelligent PRU alarm box 249 uses algorithms for calculating and presenting a robust and broadly defined patient status.

In addition to the DC, the monitoring shell, and the PRU GUI 210, the PRU 200 includes other software-driven operations. These operations include monitoring functions and utility functions. The utility functions include an auto-driver that actuates the infusion line 224 when the cartridge 251 and drug vial 250 are mounted in the PRU 200. The monitoring functions include an infusion line drive link that enables operation of the infusion line 224 when the T-cap 269 is connected to the T-base 271 of the cartridge 251. The monitoring functions also includes oxygen delivery when connected to the patient, and drug delivery when a cartridge 251 is not recognized by the PRU as previously used in the PRU.

The PRU 200 includes an uninterruptible power supply (UPS) 214, a PRU console 444 and a PRU monitor 441. These are arranged in the order described and typically sit on an SDS cart 101 or on the user's own platform.

The UPS 214 converts the wall outlet alternating current to a low voltage that supplies all the electrical energy used in the PRU console 444. A primary portion of the UPS 214 energy supplied to the PRU console 444 is used in the PRU console 44, while the remainder of the supplied the energy via the PRU console 444 goes to the PRU monitor 441 and to the BMU 300. The UPS 214 also has a rechargeable battery backup system. This is used as a temporary energy source which is switched on automatically by the UPS 214 if the alternating current from the wall outlet through an alternating current line fails. The UPS 214 also includes an electrical ground connection for the PRU console 444. There are communication means between the UPS 214 and the PRU console 444 that transmit information regarding power status and battery status. Power, communications, and ground are connected to the PRU console 444 by means of a low-voltage line, UPS output cable 490, which is integrated into the UPS 214. A UPS output cable connector 491, on the end of this UPS output cable 490, is plugged into the PRU console 444.

The UPS 214 includes an external AC power cord, a universal AC/DC power module 501, a UPS power circuit board 502, and a rechargeable UPS battery pack 503. The UPS 214 has an externally located UPS on/off switch 504, a UPS power status indicator 505 that shows the energy status, and a UPS battery status indicator 506 that shows the battery state of charge.

The UPS 214 further includes cooling fans 507 located at the rear of the UPS chassis 508. A decorative front 509 is attached to the UPS chassis 508 and the UPS top 473. The UPS top 474 and bottom 475 are of E-PAC™ which are foam structures that act to secure all internal UPS components.

The UPS 214 includes an electrical circuit that allows the UPS output cable connector 491 to be detached from the PRU console 444 while power is applied, helping to prevent contact sparks or other unwanted electrical stress on the connector. The UPS output cable connector 491 also includes means to ensure that the ground connection is the first contact provided in a connection between the UPS and the PRU, and that the ground connection is the last contact broken in a disconnection.

The PRU monitor 441 provides the user with an interface to the PRU 200 that combines a PRU monitor color display 442, a PRU monitor touch screen 443 user interface, and PRU monitor speakers 458 and 459. The PRU monitor 441 is located on top of the PRU console 444. PRU monitor 441 is powered and grounded via PRU console 444. Video and audio signals are also provided by PRU console 444. PRU monitor 441 sends PRU monitor touch screen 443 signals to PRU console 444.

The PRU monitor 441 is electrically connected to the PRU console 444 by means of a PRU monitor cable that plugs into the rear of the PRU console 444. This cable provides power, ground, video, audio, and the PRU monitor touch screen 443 -signals. The PRU monitor cable connector 463 also includes means to ensure that the ground connection is the first contact provided on a connection and the last contact broken on a disconnection.

The PRU console 444 is the central computer and process control source for the SDS 100. The PRU console 444 also contains specific functions including drug infusion, patient C02 gas analysis using capnometry, supplemental oxygen flow control, cartridge 251 barcode reading, oral/nasal -cannula 145 and drug vial 250 bar code markings arranged on the object or packaging, patient data hardcopy printing, communication in SDS 100, communication with external sources and energy management/control.

The PRU console 444 includes a PRU energy control board 453, a PRU processor board 252, a system I/O board 451, a barcode reader module assembly 455, a PRU printer 454, an IV (intravenous) pump module 220, an oxygen manifold 206 , control buttons and light indicators, connectors for external users and a PRU console fan 456. All of these are arranged within a single cabinet cover. The PRU processor board 452 and the system I/O board 451 , which are connected to each other by a flexible wiring circuit, may together be referred to as the PRU host controller 204 .

The PRU power control board 453 receives UPS 214 power entering the PRU console 444 and converts it to several regulated low voltage outputs for use in the PRU 200 and BMU 300. For example, these regulated outputs include 5 volts, 12 volts, and 15 volts.

The PRU processor board 452 is the primary source of computation for the SDS 100 and is one of the primary sources of signal input/output. Most of the SDS 100 software, including the DC and monitoring shell, resides in non-volatile memory in the PRU processor board 452. The PRU processor board 452 includes a central processing unit (CPU), RAM memory, disc-on-chip memory, and a selection of digital I/O, analog I/O, video and audio circuits.

A flexible wiring harness provides connection between approximately one hundred signal input/output lines in the PRU processor board 452 and the system I/O board 451. The wiring circuit includes a multidimensional flexible printed circuit board having approximately ten connections.

The system I/O board 451 is a multi-functional circuit board that integrates and processes signals from most circuits in the PRU console 444, including the PRU processor board 452, the IV pump module 220, the PRU printer 454, the barcode reader module 455 and several operational circuits on the system I/O board 451 itself. It also processes signals relating to other sources outside of the PRU console 444, such as signals from the UPS 214, BMU 300, and PRU monitor 441.

The system I/O board 451 has a circuit on the board itself. The system I/O board 451 also includes modules mounted on the board, such as the nasal capnometer module 140 and the oral capnometer module 202 and a momentary memory module 466.

Various system I/O board 451 functional circuits will be described in the following sections.

The flash memory module 466 is removable, accessible to the user, and provides an upgrade of the internal memory of the SDS 100 for revision of the software for system operation.

A nasal capnometer module 140 and an oral capnometer module 202 are mounted on and form part of the system I/O board 451. The nasal capnometer module 140 monitors the patient's combined nasal exhalation. The oral capnometer module 202 monitors the patient's oral exhalation. Each capnometer module 140 and 202 includes a suction pump control circuit for a suction pump that is arranged independently of the system I/O board 451 and draws in the patient sample in a controlled sampling amount. Each capnometer module 140 and 202 has sample line pressure sensors that monitor the sample line pressure in order thereby to be able to detect sample line occlusions and to be able to compensate CO2 measurements in accordance with sample line barometric pressure. Both capnometer modules 140 and 202 have their own software, which enables automatic calibration as needed, communication with the PRU host controller 204 and other functions. There is a first and second capnometer I/O circuit assigned to the system I/O board 451, which circuits serve as an interface between the respective capnometer module 140 and 202 and the PRU processor board 252. One purpose of this circuit is to be able to control the power supply to the capnometer module electronics and to the motors for the capnometer pumps 141 and 142, in accordance with orders from the PRU processor board 452.

A fast switch circuit is assigned to the system I/O board 451 and enables control of the power supplied to the electrical receptacle 461 for the PRU umbilical cable. This circuit helps to prevent sparks when connecting/disconnecting current-carrying receptacles, and interrupts the energy supply to umbilical cable connector pins that may be exposed during disconnection.

The PRU circuit 510 cooperates with a similar circuit, the BMU circuit 600 in the BMU 300, in that both of these circuits 510 and 600 cooperate with the umbilical cable 160 communication means. The PRU circuit 510 in the PRU console 444 enables the PRU console 444 to determine whether the umbilical cable 160 is plugged into the BMU 300 and whether the BMU 300 is powered or not. This condition status information is used in the PRU console 444. If, for example, PRU 200 is off and BMU 300 is on, then BMU 300 will be connected via the umbilical cable 160 to PRU 200, and PRU 200 will automatically turn itself on. Another application of the condition status is to prevent umbilical cord 160 communication alarms related to a deliberate break of the umbilical cord 160. Yet another purpose of the condition status in the PRU 200 is to assist in control when energizing the PRU umbilical cord electrical receiver 460, for thereby helping to prevent current from being applied to the exposed pins of an unplugged umbilical cable 160.

An IV pump energy control circuit controls the power of the IV pump module 220 in accordance with various commands from the PRU processor board 452 and from connections such as with the controller-monitor module 467 circuit. Also included in this circuit is a drug stop button 497 which causes a shutdown of the energy supply to the IV pump module 220 and also sends status regarding this button to the PRU processor board 452. This circuit also includes a pump door button 496, which communicates its status to the PRU processor board 452 and also contributes to the control of the door lock solenoid 222 which releases the pump door 201. Another purpose of this circuit is to send a signal regarding the status of the IV pump motor encoder to the PRU process board 452.

A PRU power button circuit monitors the power button 495, the status of which is communicated to the PRU processor board 452. The PRU power button circuit also includes an LED indicator driver circuit that supplies a ramp voltage to the LED indicator of the PRU power status indicator 498 in a standby mode, a variable light indication is provided in connection with a standby. In the on mode, this circuit will drive the LED indicator in the PRU power status indicator 498 with a continuous voltage.

A PRU printer circuit supplies electrically isolated and controlled power to the PRU printer 454 and also provides an electrically isolated connection between the PRU processor board 452 and the PRU printer 454. A barcode reader circuit supplies controlled power to the barcode reader module 455 and also provides a communication interface for the barcode reader module 455 toward the PRU processor board 452. A PRU fan control circuit controls power to the PRU console fan 456. This circuit can detect a slow or stopped PRU console fan 456 and will then send an alarm to the PRU processor board 452.

A PRU temperature sensor circuit includes a thermal sensor and signal processing and monitors the internal temperature of the PRU console 444. This temperature data is sensed to the PRU processor board 452. This thermal sensor, with associated support circuitry, is located on the system I/O board 451, where it can effectively monitor the thermal condition inside the PRU console 444.

The controller monitoring module 467 is a monitoring circuit that monitors the operation of the PRU host controller 204 and that the assigned software is used. If the controller-monitoring module 467 detects an unwanted PRU host controller 204 function (an excessively frequent or non-occurring processor activity), the controller-monitoring module 467 will send a message to the PRU processor board regarding this condition and the controller-monitoring module 467 will then take direct action to disconnect the IV pump module 220 and shut down most functions within a short time. When there is a condition detected by the controller-monitoring module 467, this will also temporarily activate a ringing device arranged on the PRU system I/O board 451, thereby informing the user of the unwanted condition.

A PRU monitor control circuit controls power to the PRU monitor 441. It is controlled by the PRU processor board 452, and the circuit includes a current limiting function. A PRU audio amplification circuit includes two audio amplification circuits that receive low audio from the PRU processor board 452 and amplify these signals. These amplified signals are used in the two PRU monitor speakers 458 and 459 in the PRU monitor 441. The monitor control circuitry includes providing a PRU monitor speaker signal to the PRU processor board 452 which helps to ensure that the SDS 100 will only operate when the PRU monitor speakers 458 and 459 are connected to the PRU console 444.

A modem circuit is a means for the SDS 100 to communicate with non-SDS devices via a telephone line. This circuit includes isolated circuits. An Ethernet circuit is a means for the SDS 100 to communicate with non-SDS devices via an Ethernet line. This circuit also includes isolated circuits.

The PRU UPS communication interface is a circuit that provides an interface between the UPS communication lines and the PRU processor board 452.

A supplemental oxygen control circuit provides the basic signal processing interface between the PRU processor board 452 and supplemental oxygen sensors. The sensors include the oxygen sensor 482, the high side oxygen pressure sensor, the low side oxygen pressure sensor and the differential pressure sensor. One of these sensors, the differential pressure sensor, is physically located on the system I/O board 451 near this circuit, while the other mentioned sensors are located at the oxygen manifold 206. The supplemental oxygen control circuit also sends signals for operation of the flow restrictor 84 with variable nozzle opening (VSO) (such as a VSO solenoid), which limiter regulates the supplemental oxygen flow. Other features are electrical control of the VSO flow limiter 480 and the signal processing interface between the PRU processor board 452 and the VSO flow limiter 480. Yet another purpose of the aforementioned supplemental oxygen control circuit is to be able to control the oxygen sampling solenoid in accordance with commands received from the PRU processor board 452.

The circuit in the system I/O board 451 to be discussed last is a voltage monitoring circuit. This voltage monitoring circuit forms an interface between the PRU processor board 452 and the various power supplies on the system I/O board 451, so that these voltages are monitored and it can be determined whether they exist in the desired ranges.

There is a nasal capnometer pump 141, arranged in the PRU console 444. This pump is connected to, but not physically attached to, the nasal capnometry module 140. There is also an oral capnometer pump 142, arranged in the PRU console 444. This pump 142 is connected to, but not physically attached to, the oral capnometry module 202.

The barcode reader device 455 includes a self-contained barcode reader module 464 which is mounted on a metal frame which includes a mirror. The metal frame is mounted inside the housing of the PRU console 444, with an orientation that allows a projection of the barcode laser beam through an open window in the PRU console 444 housing, to illuminate an area outside the PRU console 444. The user places the barcode on the package containing the oral/nasal cannula 145 or the cassette 251 or the drug vial 250 in the reading area of the laser beam from the active barcode reader module 464. The barcode reader module 464 can then read the barcode.

The PRU printer 454 includes a thermal print head, a paper feed mechanism, a printer driver plate, and a PRU printer door 460. This assembly is mounted on the PRU console 444 housing by electrically insulating means, which provides electrically isolated access to the printer paper roll. The IV pump module 220 performs a drug pumping function in the PRU console 444. The IV pump module 220 receives the disposable cartridge 251. The IV pump module 220 sends metered amounts of drug through the cartridge 251 using a peristaltic massage of the flexible tubing 277. The IV pump module 220 detects the presence of a T-cap 269 in the respective receptacle in the cassette 251 and also detects that a drug vial 250 has been placed in the respective receptacle in the cassette 251. The IV pump module 220 has other features, such as the possibility of detecting air in the line and occlusion or plugging of the downstream fluid path. Another function in the IV pump module 220 relates to the pump door 201 and a controlled opening thereof. The IV pump module 220 has an IV pump housing 239 with a pump door 201, a pump door lock 205 and a pump door lift mechanism 207, an IV pump assembly 232, an rV pump control plate 233, an optical sensor plate and an air-in-line sensor 225. IV -the pump assembly 232 has an IV pump motor, a pump finger mechanism, an IV pump motor encoder, a downstream IV pressure sensor 223 and an IV pump sensor plate. The optical sensor plate 227 has a T sensor 226 and a vial sensor 228. These two sensors pass through the IV pump housing 239 near the pump cartridge deck 221, where they interact with associated mechanisms in the located disposable cartridge 251. The optical sensor plate also has a door lock solenoid 222 which, when activated, will actuate the pump door lock 205 to release the pump door 201. The pump door 201 is lifted by the pump door mechanism 207 and moves to an open position thereby exposing the cassette deck 221 and enabling the user to gain access to insert or remove the cassette 251.

The oxygen manifold 206 is the primary component of the supplemental oxygen delivery system in the PRU console 444. The oxygen manifold 206 provides a path for oxygen flow, oxygen flow control, oxygen purge evaluation, and oxygen overpressure relief. It is mounted in the rear section of the PRU console 444.

The oxygen manifold 206 includes a manifold provided with the following details for the incoming oxygen gas, in the order set forth herein: an externally located oxygen inlet coupler 484, high-side pressure relief valve 485 and associated discharge port, high-side pressure sensor 487, oxygen distributor 492, a fixed restrictor 489, a VSO flow restrictor 480, a low side pressure sensor 488, a low side pressure relief valve 486 and an oxygen main outlet. Auxiliary gas paths include an oxygen sample solenoid 481, an oxygen sensor 482, and an oxygen sensor outlet port 483. There are also outlets for conducting the gas pressure from either side of the fixed restrictor 489 and to the differential pressure sensor 479, which is located on the system I/O plate 481. The oxygen manifold 206 has an oxygen input connector 484 that extends from the rear of the PRU console 444 for user connection to an external supply of supplemental oxygen.

The oxygen manifold 206 has a flow path that captures an oxygen sample. The oxygen sample is controlled with an oxygen sample solenoid 481 so that a stream of supplemental oxygen can temporarily bypass the assigned oxygen sensor 482. The oxygen manifold 206 has an oxygen sensor outlet opening 483 which enables the sampled gas to be sent out from the oxygen manifold 206.

The oxygen manifold 206 has a high-side pressure relief valve 485 that protects the oxygen high-pressure path from too high a supply pressure, as the pressure can be relieved via the outlet opening in the high-side pressure relief valve 485. The oxygen manifold 206 has a low-side pressure relief valve 486 that protects the oxygen low-pressure path from too high an output pressure, with any excessive pressure being relieved via the outlet opening in the low side pressure relief valve 486.

The oxygen distributor 492 is a manually operated valve that is operated using an externally accessible oxygen distribution button 493. The oxygen distributor 492 can be set in the normal position, where supplemental oxygen is only fed directly through the regulated flow path in the SDS 100 system. Alternatively, the oxygen distributor 492 can be set in an SDS system bypass position, in which the supplemental oxygen flow no longer passes directly through the SDS-100 system's regulated flow path. Instead, this oxygen flow will go exclusively directly to an externally accessible oxygen outlet 494 which provides the user with a convenient means of connecting a user supplied SDS system bypass oxygen device.

The PRU console 444 is a direct means of user input via the PRU power button 495, drug stop button 497, and pump door button 496. The PRU power button 495 enables the PRU 200 to be placed in a standby or ready mode. The drug stop button 497 enables the user to stop a drug delivery by turning off the energy supply to the IV pump module 220. The pump door button 496 enables the user to open the pump door 201 when no cartridge 251 is inserted in the IV pump module 220 or when the cartridge 251 is present and the T-cap 269 is mounted in the cassette 251.

The PRU console 444 provides the user with status indications by means of two illuminated indicators. One of these indicators is the PRU power status indicator 498, which is integrated with the PRU power button 495. This indicator has a periodically fluctuating brilliance in standby mode and a continuous brilliance in ready mode. The second indicator is the pump door lock indicator 499 which is integrated with the pump door button 496. This indicator 499 illuminates when the pump door 201 is locked, and does not illuminate when the pump door 201 is not locked.

The PRU console 444 has several external user accessible connectors. The PRU umbilical cable electrical receptacle 461, located on the front panel of the PRU console 444, is a connector to enable appropriate electrical connection for the umbilical cable 160.1 the connector uses different pin heights to enable connection without degradation of the pins. The PRU umbilical cable pneumatic receptacle 462, which is located on the front panel of the PRU console 444, is a connector for providing convenient simultaneous multiple connections with the umbilical cable 160, with pneumatic paths for oxygen delivery and patient exhalation samples. The modem connector 470, which is located on the rear panel of the PRU console 444, is an RJ11 connector that can provide the user with an external telephone line. The Ethernet connector 471, located on the rear panel of the PRU console 444, is an RJ45 connector that can provide the user with an external Ethernet line. The PRU power connector 465, which is provided in the rear panel of the PRU console 444, is a connector that can provide the user with a connection of the PRU console 444 with the UPS output cable connector 491.

The PRU console 444 has a fan, namely the PRU console fan 456. The PRU console fan 456 provides thermal cooling of the components arranged in the PRU console 444. The PRU console fan 456 also provides robust ventilation of the PRU console 444 to thereby could dilute any supplemental oxygen flow entering the PRU console 444, and will therefore help to keep the oxygen concentration within a desired range.

The internal components of the PRU 200 are arranged between an upper PRU foam support 447 and a lower PRU foam support 448. One example is the PRU foam support 447 and 448 of a rigid foam well known in the electronics industry, such as an E-PAC™ chassis. Strategically placed recesses and cavities in the E-PAC™ chassis will efficiently hold PC boards, pumps, LCD, speakers and other components. The outer housing of the PRU 200 is of a rigid and molded thermoplastic (eg ABS) and includes a top chassis 445, a top cover 446 and a front cover 450. The bottom chassis 449 is of sheet metal and forms part of the outer housing of the PRU 200. Housing Components held together by means of shaped snap details and screws. The top chassis 445 is designed so that it can be easily detached to give access to the PRU 200.

A fourth inventive aspect relates to a procedure room unit (PRU) 200 and bedside monitoring unit (BMU) 300 interface to a sedation delivery system 100 (or other type of medical effector system 100'), and an embodiment of this aspect is shown in FIG. 41-57 and 60-62. An aspect of the embodiment in FIG. 41-57 and 60-62 is a sedation delivery system 100 (or other type of medical effector system 100') that includes a microprocessor-based bedside monitoring unit 300 (an embodiment of which is shown in Figs. 41 and 60-62), a microprocessor-based procedure room unit 200 (an embodiment of which is shown in Figs. 41-57) and an umbilical cable 160 (an embodiment of which is shown in Figs. 41, 42, 60 and 61). The bedside monitoring unit 300 has a bedside monitoring unit host controller 301, a first array of ports for receiving patient input signals from patient monitoring connections, a second array of ports for patient output signals based on the received input signals, and a display screen for displaying in the at least some of the patient output signals. The procedure room unit 200 has a drug delivery current controller 220' (or another type of medical effector 220") and a procedure room unit host controller 204. The procedure room unit host controller 204 has a memory with a patient monitoring and drug delivery program (or another patient monitoring and medical effector program). The program is associated with program inputs based at least in part on at least some of the patient outputs and controls, and/or alerts a user with respect to controlling or controlling the drug delivery flow controller 220' (or other medical effector 220") based at least in part on the program inputs. The umbilical cable 160 has a first end connected or connectable to the second row of connection points in the bedside monitoring unit 300 and a second end connected or connectable to the procedure room unit 200.1 at least one of these first and second ends is detachable from the corresponding bedside monitoring unit 300 or the procedure room unit 200. The procedure room unit host controller 204 and the bedside monitoring unit host controller 301 are operatively connected to each other when the umbilical cable 160 is connected to the procedure room unit 200 and the bedside monitoring unit 300.

In one embodiment of this aspect of the embodiment of FIG. 41-57 and 60-62, the drug delivery flow control device 220' includes a drug delivery infusion pump device 220, such as a peristaltic pump device. In a variant of this arrangement, medication is delivered to the patient through an IV. In another arrangement, not shown, the drug delivery flow control device includes a flow control for a gaseous drug. In a variant of this arrangement, the gaseous drug(s) may be oxygen and/or a non-oxygen gas which is delivered to the patient through a cannula device.

In an example of the aforementioned aspect of the embodiment in fig. 41-57 and 60-62, the procedure room unit 200 has an individual procedure room unit (PRU) identifier while the bedside monitoring unit 300 has an individual bedside monitoring unit (BMU) identifier. The procedure room unit host controller 204 in the procedure room unit 200 sets up an electronic history in the bedside monitoring unit 300 when associated with the procedure room unit 200, which history is based on the individual BMU identifier. In one variant, the identifier is located in the host controllers of the PRU and BMU, and the electronic history is set up automatically when the BMU is connected to the PRU. In one variant, the sedation delivery system 100 also includes a single patient drug delivery cartridge device 251 and a single patient needle device 145 and a single patient drug vial 250. The drug delivery cartridge device 251 has an individual cartridge identifier and is operatively connectable to the drug flow control device 220' in the procedure room unit 200. The needle device 145 has an individual needle identifier and can be associated with the bedside monitoring unit 300. The drug vial has an individual vial identifier and is operatively connectable to the drug delivery cartridge device 251. The procedure room unit host controller 204 in the procedure room unit 200 sets up an electronic history of the drug delivery cartridge device 251 and the needle device 145 and the drug vial 250, based on the individual cassette needle and vial identifiers (SPU identifiers).

According to a further aspect of the embodiment in fig. 41-57 and 60-62, the procedure room unit 200 download will have an individual procedure room unit (PRU) identifier, while the bedside monitoring unit 300 will have an individual bedside monitoring unit

(BMU) identifier. The procedure room unit host controller 204 in the procedure room unit 200 sets up an electronic history for the bedside monitoring unit 300 when associated with the procedure room unit 200, based on the individual BMU identifier.

According to another aspect of the embodiment in fig. 41-57 and 60-62, the individual cartridge identifier in the drug cartridge device 251 is a unique barcode on a sterile package containing the drug cartridge device 251, and/or a barcode on the drug cartridge device 251. The individual needle device identifier for the needle device 145 is a unique barcode on a sterile package containing the needle device 145, and/or a barcode on the needle device 145. The individual vial identifier for the medication vial 250 is a unique barcode on a sterile package containing the medication vial 250, and/or a barcode on the medication vial 250. The unique identifiers are read in the PRU 200 using the barcode reader 455.

In one embodiment of this aspect of the embodiment of FIG. 41-57 and 60-62, when the bedside monitoring unit 300 is associated with the procedure room unit 200, the electronic history of the cartridge, needle and vial identifiers is provided to the BMU 300. The BMU 300 updates its electronic history of the SPU identifiers so that previously used SPU 's can be used together with the special BMU. In a further embodiment, the BMU 300 copies the history regarding the SPU identifiers to the PRU 200. This is particularly useful in connection with surgical procedure facilities where there are more BMUs and fewer PRUs. The cross copying of the SPU identifiers between the BMUs and the PRUs will further prevent a multiple use of SPUs in different PRUs in a surgical facility.

In an embodiment of the aforementioned aspect of the embodiment in fig. 41-57 and 60-62, when the bedside monitoring unit 300 is connected to the procedure room unit 200, the bedside monitoring unit host controller 301 of a switched on bedside monitoring unit 300 will turn on a switched off procedure room unit 200.1 the same or another embodiment, when the bedside monitoring unit 300 is connected to the procedure room unit 200, the procedure room unit host controller 204 in a switched on procedure room unit 200 will turn on a switched off bedside monitoring unit 300.1 a variant, when a PRU 200 or a BMU 300 is switched on, its host controllers 204 and 301 will start.

In one embodiment of this aspect of the embodiment of FIG. 41-57 and 60-62, the bedside monitoring unit 300 will display a patient monitor when it is not associated with the procedure room unit 200, and will display a patient monitor when it is associated with the procedure room unit 200 and the procedure room unit host controller 204 detects certain errors in the procedure room unit 200.1 the same or a in another embodiment, the procedure room unit host controller 204 will shut down the drug delivery infusion pump device 220 when certain errors are detected in an associated bedside monitoring unit 300 and/or in the procedure room unit 200 .

In an implementation of this aspect of the embodiment of FIG. 41-57 and 60-62, the umbilical cable 160 has a power supply line, and the procedure room unit host controller 204 will shut off the power supply to this power supply line in the umbilical cable 160 when the umbilical cable 160 is disconnected from the bedside monitoring unit 300 and/or when the umbilical cable 160 is disconnected from the procedure room unit 200.1 a variant includes the bedside monitoring unit 300 a bedside monitoring unit battery 303, and power from the procedure room unit 200 will recharge this bedside monitoring unit battery 303 via the energy supply line in the umbilical cable 160.

A fifth inventive aspect relates to a bedside monitoring unit (BMU) 300, a component thereof or can be used in connection therewith. Such an embodiment is shown in fig. 6, 41 and 60-62. A first aspect of the embodiment in fig. 6, 41 and 60-62 is a self-contained patient monitoring unit that includes an oral/nasal cannula 145, a first array of connection points for receiving input signals from patient monitoring connections, and a connector 151 for receiving a supplemental (V supply 152.

A second aspect of the embodiment in fig. 6, 41, 60-62 is a BMU 300 that receives user input signals from the patient and procedure data including a graphical user interface 212.1 such an application, the BMU 300 can be used for entering and displaying patient parameters (such as physiological parameters) in connection with a pre- procedural setup, a surgical procedure or during a post-procedure treatment.

A third aspect of the embodiment in fig. 6, 41, 60-62 is a BMU 300 capable of delivering audio commands to a patient 10 and includes an ARM module 340, an audio output through the oral/nasal cannula 145 and an earpiece 135 vibrating handpiece 342 and an input cable 150.

In an implementation of this third aspect, the BMU 300 during a pre-procedure set-up will give an audible order to the patient 10 via the earplug 135, such as "squeeze with the left hand", and will monitor the response time involved in establishing a basic response . In one embodiment of this implementation, the cannula 145 will deliver audible commands to a patient 10 requesting a response to an automatic response monitor (ARM) 340 .

A fourth aspect of the embodiment in fig. 6, 41, 60-62 is a BMU 300 in combination with a procedure room unit including an oral/nasal cannula 145, a first array of connection points for receiving input signals from patient monitoring connections, and a second array of connection points for patient output parameters and a display screen for displaying patient parameters. In an implementation of this fourth aspect, the umbilical cable 160 is connected to the BMU umbilical cable connector 151 (instead of a connection with the (Vsupply) 152) and transmits patient parameters from the BMU 300 to the PRU 200. In one embodiment, the BMU 300 brings the patient 10 to a procedure area. The umbilical cable 160 connects the BMU to the PRU 210 and the BMU 300 downloads all patient input data and parameters (including physiological parameters and CO2 measurements) to the PRU 210. The PRU 210 initiates a Cv delivery to the patient (as needed) via cable 160.

According to a fifth aspect of the embodiment in fig. 6, 41, 60-62, the BMU 300 monitors user input signals with patient parameters and enters this patient information into the graphical user interface 212 at a post-procedural processing. The BMU 300 can then be used for displaying patient parameters (such as physiological parameters) during a post-procedure treatment, can if necessary supply a (V store and can give medical personnel the opportunity to access the patient's 10 condition before a discharge. In an implementation of this fifth aspect, the BMU 300 includes a light element 208 with several LEDs to facilitate the medical personnel's overview. The light element 208 can show the patient's condition in various formats, for example in the form of green light, red light and yellow light, flashing light and steady light.

In a second implementation of the fifth aspect, the BMU 300 uses the ARM module 340 and the ARM handset 342 to automatically interrogate the patient and record time-based responses. These responses are combined with other monitored parameters to thereby obtain an overview of the patient's condition.

In the sections below, a more detailed description of a special embodiment of the embodiment in fig. 6, 41 and 60-62. It should be mentioned that features in this particular embodiment can be used in the previously described aspects (including examples etc.) of the embodiment in fig. 6, 41 and 60-62.1 this embodiment enables the BMU 300 to monitor physiological patient parameters during all procedural phases. When the BMU 300 is connected to the PRU 200 via the umbilical cable 160 in the procedure room, the physiological parameters monitored by the BMU 300 are displayed on the PRU 200. The BMU 300 contains the BMU host controller 301, which is the computer for the device. The BMU 300 host controller 301 includes both hardware and software components. The hardware includes interface components for communication with the patient monitors. This communication includes receiving patient data, monitoring operational status and sending routine orders to the modules. The software processes the data received from the patient monitors for display in the display monitor. The software contains drivers for the visual display monitor, touch screen, speakers, ARM functions, internal memory, and printer. The BMU 300 is designed to remain with the patient during the procedure movement from the pre-procedure room to the procedure room and finally to the convalescent or final treatment room.

BMU 300 includes an electrocardiogram (ECG) module 330, which includes electronics, and software used to process patient signals delivered through ECG pads 332 and ECG leads 334. ECG pads 332 and ECG leads 334 are well known in medicine. An example ECG module 330 is available from Mortara Instrument, Inc., Milwaukee, WI, USA, model M12A. The data coming from this module is sent to the BMU host controller 301 for displaying the patient's physiological parameters (heart beat and waveform).

The BMU 300 also includes a non-interventional blood pressure (NIBP) module 320. The NIBP module 320 includes an NIBP pump 322. An example of such an NIBP module 320 is available from SunTech Medical Instruments, Inc., Morrisville, NC, USA, model MC2619045. The non-interventional blood pressure (NIBP) module 320 contains the electrical components, software, pump and valves necessary to inflate the non-interventional blood pressure cuff 321. Such NIBP cuffs are well known in the medical field. The electronic components will software process the information received from the NIBP cuff 321. The resulting blood pressure data (systolic, diastolic pressures) is then sent to the BMU host controller 301.

The pulse oximeter module 310 (SpC^) is also provided in the BMU 300. An example of a pulse oximeter module 310 is available from Dolphin Medical, Inc., Hawthorne, CA, USA, model OEM701. The pulse oximeter module 310 contains the electronic components and the software used to process the patient information received from the reusable pulse oximeter probe 311. An example pulse oximeter probe 311 is available from Dolphin Medical, Inc., Hawthorne, CA, USA, Model 210. The resulting data (pulse, SpC>2 and waveform) is sent to the BMU host controller 301.

In the BMU 300 there is also an automatic response monitor (ARM) module 340. This module 340 includes an ARM speaker device 341. During a procedure, the ARM module 340, which contains hardware and software, will provide simultaneous audible and tactile stimulation via the earplug 135 and a vibrating ARM handset 342 for the patient. The ARM Handset 342 is ergonomically designed for comfortable adaptation to the patient's hand and is held in the hand by means of a strap. The stimuli continue for a specified period of time, or until the patient responds by squeezing the handset 342, which activates a mechanical switch in the handset and sends a signal to the ARM module 340. The ARM audio stimulus is a request ("please squeeze your hand") and a gentle vibration of the handset 342. If the patient does not respond, a more clear sound request is repeated ("squeeze with your hand") and the vibration intensity increases, which may also include an increase in the sound volume. If the patient still does not respond, an even louder audio request ("squeeze your hand now!") is repeated and the ARM handset 342 vibrates at an intensity that is increased a third and final time. If the patient does not squeeze the handset 342 during this sequence, the patient is assumed to be unresponsive. If the patient does not respond within the set time period, the monitoring shell will take action and notify the staff.

The oral/nasal cannula 145 is attached to the patient with 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 the oral/nasal cannula 145 is connected to the BMU 300 via a cannula connector plate 304. The cannula connector plate 304 fluidly connects outputs from the oral/nasal cannula 145 to the BMU 300. The cannula connector plate 304 also connects outputs from the BMU 300 to the oral/nasal cannula 145.1 BMU 300 is equipped with a pressure transducer (which in an example can be a nasal pressure transducer 47) which detects whether the patient is breathing in or out and is connected to the PRU 200 for controlling the oxygen flow. The oral/nasal cannula 145 also includes an earplug 135, which delivers audible commands to the patient from the ARM module 340.

An energy or power button 318 is arranged on the surface of the BMU 300 and lights up green when the BMU 300 is switched on. A green pulse is emitted when the BMU 300 is in a standby mode. BMU 300 has a user interface that always sends information from the physiological monitors and sensors to the user and thereby enables the user to enter information and orders into the control system. The BMU Graphical User Interface (GUI) 212 includes a backlit LCD display monitor with a touch screen for user input and an alarm system with audio and video components. The speaker 216, which is arranged to give the user an audible indication, is arranged on the surface of the BMU 300. A light element 208 is arranged on the upper part of the BMU 300 and is molded in a semi-transparent thermoplastic (e.g. polycarbonate). The lighting takes place by means of LEDs 203 which provide a visual indication of alarm conditions. The light element 208 is particularly useful for sending information to the medical staff in the post-procedure room, where several patients may find themselves convalescing after surgical procedures, since there are also several BMUs in the room. When patient physiology exceeds warning and alarm thresholds, the digital display will indicate an alarm condition. In addition to the visual indicators, the BMU can include clear audible alarm tones. The light element 208 can, for example, show or give a flashing green light when the BMU 300 does not detect any abnormalities, and can show or flash yellow when a warning occurs. In the event of an alarm, red is displayed or flashes. Furthermore, the light element 208 can change colour, intensity and flashing cycle to thereby show ventilation amounts and/or status. The light element 208 may also include alpha, numeric or alphanumeric displays. Such screens can contain additional and more detailed information, such as heartbeats per minute, breath volume or alarm details.

A separate thermal printer can be used to provide a hard copy record of sedating information. The printer port 218 is arranged on the side of the BMU 300 for connection with a remote printer. The BMU 300 can either use its own battery power, the BMU batteries 303, or can receive alternating current from outside via an adapter. Furthermore, the BMU 300 receives power or energy from the PRU 200 when these are connected in the procedure room. An oxygen adapter 152 and a tubing set may be connected between the BMU 300 and a standard oxygen wall outlet or an oxygen tank, thereby enabling oxygen to be conveniently delivered to a patient through the BMU 300 when the BMU 300 is not connected to the PRU 200 via the umbilical 160 (typical pre-procedure and convalescence).

As best in fig. 62, the internal components of the BMU 300 are arranged between an upper foam support 312 and a lower foam support 313. For example, these foam supports/supports 312 and 313 respectively are formed from a rigid foam well known in the electronics industry, such as an E-PAC™ chassis. Strategically arranged recesses and cavities in the E-PAC™ chassis will efficiently hold PC boards, pumps, LCD, speakers and other components. The outer housing of the BMU 300 is made of a rigid and molded thermoplastic material (for example ABS) and includes a bottom 314, a front 315, a back 316 and a top 317. The housing components are held together by means of molded snap details and screws. The housing top 317 is intended to be removed in a simple way, thereby providing access to the batteries 303.

In the following paragraphs, with reference to fig. 63-76, a combination of special examples of the inventive aspects described above is described. It is a sedation delivery system (SDS) 100, which is an integrated monitoring and drug delivery system intended as a means of sedating a patient during medical procedures. The SDS 100 uses a drug delivery algorithm referred to as a Dose Controller (DC) and an intravenous infusion pump 220 to deliver drug at a variable infusion rate, which is rapidly achieved and provides a desired sedation effect. This enables the doctor/nurse (non-anesthesiology) to set the patient's sedation level by simply inserting the amount of dose that they assume will produce the desired sedation effect. DC will calculate the appropriate dose, based on guidelines in connection with the drug, which will quickly provide the sedation effect with a given retained amount.

The SDS 100 has four physiological routine monitors. These are a pulse oximeter 110 for monitoring the patient's arterial oxygen content, a non-invasive blood pressure monitor 120 (NIBP) and electrocardiogram (ECG) pads 332 for monitoring the patient's cardiodynamics, and a capnometer 140 and 202 for measuring the patient's respiratory activity. In addition, the SDS 100 includes an automatic response monitor (ARM) 150 that assists personnel in determining the patient's level of sedation. All five monitors and the DC are integrated using a program module known as the monitoring shell. The monitoring shell is designed to keep the patient at the desired sedation level. It monitors the patient's condition, keeps the healthcare staff informed of the patient's status and immediately stops the delivery of medication if an unwanted state of sedation is detected. In some cases, the monitoring shell will restart drug delivery, but with a reduced amount, as soon as the patient's condition has returned to a desired state of sedation. The monitoring shell will not start the infusion again if such inactivation is desirable based on the unwanted sedation state. Instead, an intervention by the health personnel will be required to start the drug delivery again after such a condition. An integral part of the monitoring shell is the procedural room unit (PRU) graphical user interface (GUT) 210 and the bedside monitoring unit (BMU) graphical user interface 212. Each of these displays the monitored physiologic values in a manner that enables the healthcare professional to easily determine the patient's status. The GUI is also designed to provide the health care professional with an effective means of regulating the patient's sedation level by means of changes in the amount maintained.

SDS 100 is designed to enable continuous hemodynamic monitoring of the patient in the pre-procedure room, in the procedure room and in the convalescent room (post-procedure room). It includes two main units, namely the bedside monitoring unit (BMU) 300 and the procedure room unit (PRU) 200. The BMU 300 is connected to the patient in the pre-procedure room and remains with the patient during convalescence. The BMU 300 contains a pulse oximeter module 310, an NIBP module 320, an ECG module 330 and an ARM module 340. When connected to the patient, it will monitor and display the patient's arterial saturation, arterial pressure and heart rate. Supplemental oxygen (which includes oxygen-enriched air) can at this time be delivered via the BMU 300 and the oral/nasal cannula 145. When a patient is wheeled into the procedure room, the BMU 300 will be connected to the PRU 200 by means of the umbilical cable 160, which includes both pneumatic and electrical lines. During the procedure, the umbilical cable 160 will enable the PRU 200 to receive physiological patient data from the BMU 300 as well as patient respiratory gas. In addition, the umbilical cable 160 enables an oxygen delivery to the patient from the PRU 200.

The PRU 200 adds capnography to the system, with monitoring and display of the patient's breathing volume and end-C02. The ARM monitoring is activated and the patient's response is displayed to the healthcare staff. As soon as the PRU 200 detects breathing activity (from the capnometer), a necessary oxygen delivery is started. All drug delivery is accomplished by the PRU 200, which contains the intravenous infusion pump 220, the DC one, and the monitoring shell. Drug infusion cannot be started until all the monitors are connected and giving real values, and before oxygen is delivered to the patient. The PRU 200 is the main interface between the healthcare personnel responsible for the administration of the sedation and the SDS 100. It contains the GUI 210 which displays the patient's status and enables regulation of the patient's sedation level.

PRU 200 is, with reference to fig. 42 and 43, a component of the system that provides: monitoring and display of the physiological patient parameters, the user input of patient data, the user input of dose amount, and hardware and software for drug delivery during the procedure. The PRU 200 is designed to be in the procedure room and is the mechanism used for drug delivery.

Two capnometers 140 and 202 are arranged in the PRU 200, which are used for sampling CO2 from the areas in front of the patient's mouth and nostrils. Software monitors the breathing activity, and the location with the greater breathing activity is displayed to the user. Sensors analyze the samples, and the resulting data (breath volume, EtCO 2 , and breath waveform) are sent to the PRU host controller 204 .

The sedation delivery system 100 is a device for delivering a sedating drug to a patient during a medical procedure. The amount of sedative drug that is delivered to the patient is determined by the patient's response level as measured by the ARM system 340.1 an alternative embodiment is the patient's pain level that determines the amount of sedative drug that is delivered to the patient. The patient's pain level can be indicated using physiological parameters, such as increased heart rate and/or blood pressure and/or brain activity. The sedation delivery system 100 has a capability to monitor cardiac function using the ECG monitor and blood pressure using the NIBP monitor. An EEG (brain wave) monitor may optionally be assigned to the sedation delivery system 100 for monitoring a patient's brain activity. The sedation delivery system 100 therefore interprets an increased output value from the ECG, NIBP and/or EEG as an indication that the patient feels pain or stress, and then adjusts the drug delivery for a better condition for the patient. For example, the sedation delivery system 100 will increase the drug flow to the patient or notify the staff that the drug supply should be increased if one of the ECG, NIBP and/or EEG monitors shows values above a predetermined threshold, for example 20% during a predetermined time period. Other monitored physiological parameters would be possible with such an arrangement, as those skilled in the art would appreciate.

With reference to fig. 42 to 47, infusion pump 220 is arranged in the front part of PRU 200 and provides delivery of drug(s). Disposable cartridge 251 cooperates with pump 220. The cartridge 251 holds a drug vial 250 from which drug(s) are delivered to the patient. The cassette 251 includes a base plate which holds the vial tip 261, the infusion tube 277 & 259, and the T-luer connector 269 disposed at the patient end of the infusion tube. As shown in fig. 44, opens the pump door 201 of the PRU 200 to accept the cartridge 251 and secure the cartridge 251 in the correct position with the pump 220 when closed. The T-sensor 226 is an optical sensor arranged in the pump 220 and which is used to notify the PRU host controller 204 that the T-site 269 is activated when the cassette 251 is inserted. Another optical sensor in the pump 220 is the vial sensor 228. It is used to tell the PRU host controller 204 that a medication vial 250 is present. The air-in-line sensor 225 is an ultrasonic device that spans a short section of tubing 277 and detects the presence of air or air bubbles being pumped through tubing 277 from the drug vial. An occlusion detector 223, arranged in the pump 220, is a small pressure transducer which has contact with the hose 277, in order to thereby detect a possible increase in the hose pressure which would indicate a possible occlusion in the infusion hose 259. Pump fingers 229 interact with a section of the hose 277 which is placed over the top of the cassette 251, and their peristaltic pumping action causes drug to be pumped from the drug vial 250, through the tubes 277 & 259 and to the patient. The pump 220 is operated by software on electronic circuit boards that interact with the PRU host controller 204.

Fig. 45 shows a correct placement of the cassette 251 in the pump 220 and shows an open pump door 201. Fig. 46 shows the cassette 251 placed in the pump 220, a closed door 201 and a drug vial 250 for placement on the vial spike 261. Fig. 47 shows the cassette 251 inserted in the pump 220, a closed door 201 and a drug vial 250 which is placed on the vial spike 261.

In PRU 200, see fig. 42 and 43, an oxygen delivery module 206 is provided, which controls the delivery of oxygen to the patient during the procedure. The oxygen delivery module 206 includes sensors, flow control devices and pipes or hoses used for the oxygen delivery. One of the sensors measures the oxygen concentration in the line from the PRU 200. If the oxygen concentration is below a predetermined level, the oxygen delivery will not be permitted and a corresponding message will be displayed to the user. This feature is intended to help prevent delivery of a gas other than oxygen to the patient.

The graphical user interface (GUI) 210 enables the PRU 200 to send information from the physiological monitors and sensors to the user, and enables the user to enter information and orders. The graphical user interface 210 of the PRU includes a visual display monitor with a touch screen for user input and with an alarm system with audio and video components. In addition, a printer is used to provide a hard copy registration with sedating information. When the monitored physiological patient measurements are within certain desired parameters, an alarm box area on the monitor will show green. If the breathing volume or the oxygen saturation (SpC^) is outside a desired state by a first amount, then a status element will indicate a first alarm state by displaying a yellow color. If the same physiological parameters lie outside the desired range by a larger second amount, then the respective status element will indicate a second alarm condition by showing red. In addition to the visual indicators, the SDS 100 has clear audible tones for different alarm levels (ie yellow or red).

The PRU 200 supplies power from a universal power supply (UPS) 214, which converts the available AC voltage to a constant DC voltage. This voltage is supplied to all modules SDS 100. The UPS 214 includes a battery-powered backup system that will give the user a few minutes of system time in the event that the power supply should fail.

The PRU 200 includes the PRU host controller 204 which has both hardware and software modules. The hardware contains interface components for communication with all patient monitors. This communication includes receiving patient data, monitoring operating status and sending routine orders to the modules. The software includes process data received from the patient monitors for display on the video monitor. The software includes drivers for the display screen, touch screen, speakers, internal memory, printer, ARM functions, Ethernet port, external video display, internal sensors and the infusion pump 220.

An operational software controls the interaction with and the function of the SDS 100. With the help of the monitoring shell, the software will be able to make decisions based on information it receives from the user input, various internal sensors and patient monitors. If the patient's status reaches a level that is outside a desired condition limit assigned to a deeper sedation than desired (for example, low respiratory rate or low oxygen saturation), the software will take appropriate measures and notify the user and reduce or stop the administration of medication. The software also causes a delivery of medication based on the dose quantity that the user has prescribed. The infusion model is based on pharmacological principles and uses the patient's weight together with the desired dosage to calculate the drug infusion rate.

For the benefit of a user, the SDS 100 includes software for automatically driving the patient infusion line 224 when a valid drug delivery cartridge and drug vial are placed in the infusion pump 220. For monitoring, with the cartridge 251 mounted in the infusion pump 220, a sensor will detect the presence of the T-connector on the drug delivery cartridge 251 .The SDS operates the infusion line 224 when the T site is detected as associated with the drug delivery cartridge.

In the sections below, examples are given of several SDS 100 subsystems which include components from one or more of the above-described aspects, and the one above-described combination of special examples of inventive aspects.

The oxygen delivery subsystem receives supplemental oxygen from a standard user-supplied external source and delivers the oxygen to the patient in a controlled flow pattern influenced by the patient's breathing pattern. When the patient exhales primarily from a nasal aspect, the oxygen will have a higher flow rate during inhalation and a lower flow rate during exhalation. If the patient breathes primarily orally, then the oxygen is supplied continuously. The flow amount or rate can be set with the user input of the PRU GUI 210. The oxygen is delivered to the patient through the oral/nasal cannula 145, which has a specialized mask-like portion that attaches to the patient's oral/nasal zone.

The oxygen flow is controlled in the PRU console 444 in accordance with algorithms that are influenced by the patient's nasal pressure. The metered oxygen flow provided in the PRU console 444 is delivered to and routed through the umbilical cable 160 and to the BMU 300. The BMU 300 delivers the oxygen to a disposable oral/nasal cannula 145 that is associated with the BMU 300. This oral/nasal cannula 145 delivers the oxygen to the patient , via the oxygen hose 353, and delivers the oxygen to the patient's nasal and oral zones via two nasal oxygen branches 422 and one oral branch 369.

The oxygen delivery subsystem has several auxiliary oxygen-related functions, primarily located in the PRU console 444. These functions include a means of verifying that the supplemental oxygen supply is not hypoxic and that the oxygen content is not lower than ambient air. If a hypoxic gas is detected, the PRU console 444 will shut off the gas supply to the patient and alert the user. Another auxiliary oxygen function is a protection against an unintentionally high pressure in the supplemental oxygen supply from the user's supplemental oxygen source, as such pressure is relieved by a pressure blowout. Another auxiliary oxygen function is a protection against an unintentionally high oxygen pressure in the oxygen flow path with the relatively low pressure, as such a high oxygen pressure is relieved by means of a blow-out. Another auxiliary oxygen function is the detection of a disconnected pneumatic umbilical cable connector A 161 or a pneumatic umbilical connector B 162, either at the PRU console 444 or at the BMU 300, or a detachment of the oral/nasal cannula 145 from the BMU 300. When the oral/nasal the cannula 145 is disconnected from the BMU 300, oxygen will no longer be delivered to the calculated patient location. Such disconnection is detected by the PRU console 444 observing an unexpected pressure level as measured in the oxygen delivery path. When a disconnection is detected, oxygen delivery is automatically stopped with the PRU console 444 until the user cancels the disconnection. Another auxiliary oxygen feature is a manually operated oxygen gas valve, called an oxygen distributor 492, at the rear of the PRU console 444. This oxygen distributor 492 allows the user to conveniently manually direct incoming supplemental oxygen away from the interior of the PRU console 444 and instead deliver the oxygen supply to an SDS system bypass fitting, namely the oxygen outlet 494. This oxygen outlet 494 enables the user to access oxygen via the SDS 100 for use in other oxygen equipment, which can be utilized by bypassing the SDS system.

The oxygen manifold 206, disposed in the PRU console 444, is a metal structure containing internal hollow passages that will be effective means of directing supplemental oxygen to or through oxygen-related measuring and control devices mounted on the oxygen manifold 206 or not mounted on the oxygen manifold 206 , but wired to the oxygen manifold 206. The user connects supplemental oxygen to a connector on the oxygen manifold 206, an oxygen input connector 484, located at the rear of the PRU console 444. This incoming oxygen is pressure measured by a high-side pressure sensor 487, located on the oxygen manifold 206, which sensor monitors the high side pressure and delivers corresponding data to the PRU host controller 204. This incoming oxygen also goes to a high side pressure relief valve 485, located on the oxygen manifold 206, which valve will relieve excess pressure to the ambient atmosphere. This incoming oxygen is also fed to an oxygen sampling solenoid 481 which will normally be closed except during a sampling. When the PRU console 444 checks the incoming oxygen for possible hypoxic content, the oxygen sample solenoid 481 is momentarily opened. This provides a stream of incoming oxygen that travels in an auxiliary gas path past the oxygen sensor 242 and finally out of the oxygen manifold 206 and into the atmosphere. The PRU host controller 204 compares this sample with the oxygen content in the ambient air, the oxygen concentration in the ambient air being measured before or after receiving the oxygen sample. If the incoming oxygen sample has a higher oxygen content, the supplemental oxygen supply to the PRU console 444 will be determined to be non-hypoxic and will then be allowed to be used in the SDS 100.

The primary gas path for incoming oxygen continues into the oxygen diverter 492. The oxygen diverter 492 will normally allow the oxygen to pass in the primary gas path. However, if the oxygen diverter button 483 is in the SDS system bypass position, then the oxygen is instead directed away from the primary gas path and into an external oxygen outlet port 478 which acts as a flow restrictor. The oxygen then goes to an external nozzle, an oxygen outlet 494. The primary oxygen path continues to the fixed restrictor 489, which has a fixed nozzle orifice, which restrictor enables a controlled restriction of the oxygen flow and delivers a differential pressure across the orifice proportional to the flow rate through the fixed the restrictor 489. The differential pressure, as seen on either side of the fixed restrictor 489, provides an oxygen flow rate in the primary gas path, the flow being measured implicitly via a pair of tubes that carry these two pressures to a differential pressure sensor 479 located on the system inlet/outlet (IZO) plate . The differential pressure transducer 479 sends oxygen pressure data to the PRU host controller 204. The PRU host controller 204 determines the actual oxygen flow rate through the fixed restrictor using mathematical formulas and correlation data tables.

The oxygen continues past the fixed restrictor 489 and into a voltage sensitive (VSO) solenoid, designated a VSO solenoid 480, which solenoid has an opening size proportional to the voltage applied to the actuator winding. This variable gas flow limitation means that the PRU console 444 can influence the oxygen gas flow amount, including a complete shutdown of the oxygen flow if necessary. The VSO solenoid 480 is operated by the PRU host controller 204 in accordance with the oxygen management algorithm, using a hardware/software feedback loop that includes the differential pressure sensor 479. The output of the VSO solenoid 480 goes to a low side pressure sensor 488 which monitors the low side pressure and provides corresponding data to The PRU host controller 204.

The primary gas path continues past a low side pressure relief valve 486 which will relieve excess pressure to atmosphere. The oxygen exits from the oxygen manifold 206 at a nozzle which is connected to a flexible hose. This flexible tubing carries the flow-controlled oxygen to the umbilical cable pneumatic receptacle 462 located at the front of the PRU console 444. One of the channels in the PRU umbilical pneumatic receptacle 462 is intended for oxygen delivery. The umbilical cable 160 is connected by the user to the PRU umbilical pneumatic receiver 462. The controlled flow of oxygen passes through the umbilical cable 160 via a dedicated oxygen line in the umbilical cable 160, and is led into the BMU 300 at the other end of the umbilical cable 160.

The capnometry subsystem (CFS) is a means of measuring and displaying the patient's exhaled C02 levels, end-C02 (EtC02) and respiratory rate (RR). This C02-related data is displayed on the PRU screen in the form of a C02 graph, an EtC02 value and an RR value that will be updated on a breath-by-breath basis. CFS collects patient exhalation samples nasally and orally, monitors the patient's nasal exhalation rate, analyzes the exhalation samples for C02 content, selects the most robust C02 data, nasally or orally, according to algorithms, which then display the most robust data and derivatives of these data on the PRU monitor.

Auxiliary functions of the CFS include detection of an occluded or partially occluded exhalation sample air line, filtration to protect against the ingress of airborne particles that could affect the measurement sensor, extended capacity for capturing water condensate from the sample air, and reduction of the moisture content of the sample air to thereby avoid a precipitation of fluid in the measuring sensor.

The cannula has two nasal exhalation test ports for the left and right nostrils. Each sample port has its own dedicated sample line that goes to the needle SPU (single-patient-use) connector. The needle-SPU connector body combines the sample paths of these two tubes into a single sample path where the two samples are mixed. At this point, a single nasal-dedicated water trap is used to separate out any precipitate. The combined nasal sample will be in the SPU needle connector as a nasal exhalation sample. There are also two additional tubes that come from the left and right nasal sample ports and which transfer the pressure in these two ports to the needle-SPU connection. These two pressure signals are fed separately to the output of the needle-SPU connector without being combined with each other.

The cannula has an oral exhalation sample port that is positioned in front of the mouth. This sample port has its own dedicated sample tubing that goes to the needle SPS connector. At this location, an oral-dedicated water trap is used to separate out any precipitate. The oral sample will be available as an oral exhalation sample output in the needle-SPU connector.

The BMU cannula connector receives the cannula SPU connector and associated nasal/oral exhalation samples and a nasal pressure signal. The nasal exhalation sample is, via hoses, passed through the BMU and will be present at the BMU's pneumatic reception as a single pneumatic line in the connector. The oral exhalation sample is passed through the BMU and will be present at the BMU's pneumatic reception as a single pneumatic line in the connector. The nasal pressure test is terminated in the BMU at the nasal pressure sensor. The nasal pressure sensor signal is measured in the BMU expansion plate, and the nasal pressure signal data is fed to the PRU console 444 via the BMU electrical umbilical connector and associated umbilical cable.

The oral and nasal exhalation samples pass through oral and nasal transport tubes in the umbilical cable. The samples are delivered to the pneumatic PRU receiver, which transfers these exhalation samples to the PRU console 444.

The nasal exhalation sample is then passed through a hydrophobic filter that prevents airborne particles and water droplets from passing through the system. The filtered exhalation sample is fed, via hoses, to the nasal capnometer module. The nasal capnometer module takes C02 measurements of the exhaled breath sample as it passes through the capnometer's C02 sensor. The nasal capnometer is an OEM (original equipment manufacture) device manufactured by Cardio Pulmonary Technology Inc., part no. C02WFA. The capnometer contains an infrared (IR) sensor, control electronics, pressure sensor and a pneumatic reservoir. The exhalation sample exits the nasal capnometer module and via tubing to the nasal capnometer pump 141, which is located in the E-PAC™ chassis in the PRU console 444. The nasal capnometer pump 141 provides the negative pressure used to drive the sample from the cannula into the The PRU console 444. The nasal capnometer pump 141 is controlled by control electronics for the nasal capnometer module, which electronics control and regulate the airflow in accordance with a desired flow rate. The nasal exhalation sample passes through the nasal capnometer pump 141 and through tubing to an outlet port in the PRU console 444, where the gas is diluted with air in the PRU console 444 that is circulated by the PRU console fan.

The oral breath test passes through a filter that prevents airborne particles from passing through the system. The filtered exhalation sample goes via tubing to the oral capnometer module. The oral capnometer module takes C02 measurements of the exhaled breath sample as it passes the capnometer's C02 sensor. The oral capnometer is an OEM device, manufactured by Cardio Pulmonary Technology Inc., part no. C02WFA. It contains an infrared (IR) sensor, control electronics, pressure sensor and a pneumatic reservoir. The exhaled sample exits the oral capnometer module and via tubing to the oral capnometer pump 142, which is located in the E-PAC™ chassis in the PRU console 444. The oral capnometer pump 142 provides the negative pressure that drives the sample from the cannula into the PRU console 444. Control electronics in the oral capnometer module control the oral capnometer pump 142, and control and regulate the air flow in adaptation to a desired flow rate. The oral exhaled sample passes through the oral capnometer pump 142 and through tubing to an outlet port in the PRU console 444, where the gas is diluted with air in the PRU console 444 that is circulated by the PRU console fan.

The nasal pressure subsystem monitors the patient's nasal exhalation pressure and the corresponding pressure data is used in a nasal pressure algorithm to determine whether the patient is 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 in the individual nasal canal in the cannula body is transmitted through two independent pneumatic lines to the cannula connector that the user has connected to the respective BMU reception. These two pneumatic lines are combined as a single pneumatic pressure signal in the needle connector. This nasal single pressure signal goes to the BMU. The nasal pressure is transmitted through a single tube to a BMU pressure sensor arranged in the BMU. The BMU pressure sensor measures the relative nasal pressures in the cannula body and converts such analog pressure into an electrical signal that is processed in the BMU expansion board and communicated via the umbilical cable to the host controller in the PRU.

The PRU host controller uses pressure signal analysis algorithms and provides synchronization signals that provide timing with respect to specific events, namely, when nasal inhalation has begun and when it has ended, when nasal exhalation has begun, and when nasal exhalation has ended. In the event that the patient is in an oral breathing mode, the nasal pressure signal will be sufficiently weak to be recognized by these algorithms, and an instruction is provided to the PRU host controller indicating that an oral breathing mode is present.

The nasal inspiratory/expiratory timings and the oral inspiratory/expiratory timings are used in the breathing subsystem to coordinate the timed delivery of a variable flow of oxygen, and also to coordinately select oral or nasal capnometer data for use in a displayed C02 waveform, EtC02 calculation and display, and respiratory rate calculation and display.

The breathing subsystem includes the supplemental oxygen subsystem, the capnometry subsystem, and the nasal pressure subsystem. These subsystems work in a coordinated manner using system-level algorithms and control programs.

When a patient is in an oral breathing mode, the oxygen delivery subsystem is adapted to set the oxygen flow at a continuous flow rate. When the patient is in the nasal breathing mode, the oxygen delivery subsystem is configured to affect the oxygen flow between a fast and a slow flow rate in synchrony with the patient's inspiratory/expiratory rate. Synchronization is accomplished by the nasal pressure subsystem, which determines whether nasal inhalation has begun and when it has ended, and when nasal exhalation has begun and when nasal exhalation has ended. These detections of the beginning and end of inhalation/exhalation, respectively, serve as instructions for controlling step changes in the oxygen flow rates. The oxygen delivery will therefore be a varying flow quantity which is synchronous with the patient's breathing cycle.

The medication delivery sub-system is a means of controlled delivery of medication from the medication vial 250 which is inserted into the PRU console. Medication pumping means include an IV pump module that works in conjunction with an inserted cartridge. The drug pump rate is controlled by orders to the IV pump module from the PRU host controller.

Auxiliary functions of the drug delivery subsystem include locking/unlocking the pump door, detecting the T-luer position in the intended cartridge insertion position, detecting the presence of a drug vial in the cartridge, air-in-line detection for detecting air in the IV line, detecting occlusion in the rV line and a monitor for detecting unwanted pumping.

Pumping is enabled when the T-cap is arranged in the cassette. The pump door can be opened when the T-cap is arranged in the cassette.

The umbilical cable current control subsystem (fast break and state circuit) includes the umbilical cable in cooperation with a fast PRU console switch, a PRU state switch, a fast BMU switch, a BMU state circuit, and the PRU host controller.

The umbilical cable carries power from the PRU to the BMU. The power supplied to the BMU is for driving the BMU-related circuit which includes charging the BMU battery. The umbilical cable uses a power management subsystem that enables a "hot swap" of the umbilical cable while the equipment is powered. The umbilical energy management interrupts the energy supply when the umbilical cable connector is slightly loosened relative to a full connection. This helps to prevent possible sparks during the breaking of the umbilical cable and also helps to prevent the umbilical cable connector contacts from being stressed too much as a result of poor connector connection. These energy terminating measures are implemented regardless of which end of the umbilical cable is detached. These functions are provided by means of a transition arranged at each end of the umbilical cable, between the shortest pin, called the fast pin, in the connector, and the current return pin in the connector. The connection provided at the first end of the umbilical cable is detected by the quick switch in the PRU console. The connection provided at the other end of the umbilical cable is detected by the fast BMU switch.

When disconnecting the umbilical, the fast pin will be the first to lose contact with the respective receptacle. This triggers the respective quick switch to break the current through the umbilical cable's power pins.

Another function of an example of the umbilical cable power management subsystem is to help shut off power to the umbilical cable connector pins at each end of the umbilical cable when the umbilical cable is disconnected from the PRU or BMU. This function is accomplished using the fast switch in the PRU console, 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 together with the PRU state circuit will detect the disconnection and the PRU state circuit will then turn off the fast PRU switch, breaking the power supply and communication with the umbilical, so that the pins in the umbilical cable is no longer supplied with power. In this example, in the event of a non-nominal condition of some aspect of the condition circuit, the absence of communication via the umbilical cable will be detected and tagged by the PRU host controller as a possible disconnection of the umbilical cable, which will result in a trip signal to the fast switch. The quick switch will break both power and communication line signals to the umbilical cable.

In the following paragraphs, a description of an example of a particular use of SDS 100 is given, without the intention being to limit the invention to such an example. As shown in fig. 77-80, components of SDS 100 are used in a surgical procedure, including pre-procedure and post-procedure. The patient arrives in the pre-procedure room, step 1200. A caregiver or technician mounts the BMU 300, either to a bed rail or to an IV pole, step 1201. The BMU 300 has an IV pole clamp or a quick coupler for quick and easy mounting of the device, either on the bed rail or the IV pole. Once the BMU 300 is in place, the caregiver or technician can connect the NIBP cuff 120 and pulse oximeter probe 110 to the patient, step 1202. These connections occur between the patient and the BMU 300. The BMU 300 will automatically begin monitoring parameters such as diastolic and systolic blood pressure, mean arterial pressure, pulse rate, oxygenation plethysmogram, and oximetry value, steps 1203 and 1204. The records of the BMU 300 will be displayed to the nurse or technician on the BMU GUI 212. While monitoring the patient parameters, the nurse or technician will be able to perform other tasks. As is common in today's practice, the caregiver or technician will need to complete a pre-procedure assessment, step 1206. The pre-procedure assessment may include recording patient vital signs, determining known allergies, and determining the patient's past medical history. Once the nurse or technician has completed the pre-procedure assessment, step 1206, the nurse or technician can start the peripheral IV by inserting a catheter into the patient's arm, step 1207. The IV catheter is connected to the primary IV drip device, such as a 500 ml bag of saline fluid. Following these activities, the caregiver or technician may begin placing ECG pads 130, ARM handset 342, ARM earplug 362, and oral/nasal cannula 351 on the patient, step 1208.

Once the patient is connected with these details, the caregiver or technician can explain the ARM system 340 to the patient. This explanation may include the caregiver or technician telling the patient to respond to audible stimulation from the earplug 362 and/or to tactile stimulation from the ARM handset 342 by squeezing the ARM handset 342. If the patient responds to neither audible nor tactile stimulation, increase the intensity of the stimulation until the patient responds properly. At this point, the caregiver may initiate an automatic ARM training, step 1209. An automatic ARM training is a program run by the BMU 300 that teaches the patient how to detect an ARM stimulus and how to respond to such a stimulus, and determines a baseline response for the patient to the stimuli, as described in the aforementioned US patent application serial no. 10/674,160. The carer or technician is free to carry out other patient-related tasks while the patient participates in the automated ARM training. The BMU 300 will display the training status so that the carer or technician can quickly decide whether the patient is participating in the automatic training. The patient must successfully complete the automated ARM training to proceed, step 1210. If the patient does not complete the training, a caregiver or other must intervene and decide whether the patient should continue, step 1210-A. If the caregiver or other determines that the user can continue, the patient goes to step 1211. If the personnel determines that the patient is unable to continue, then the procedure is canceled, step 1213. The user can customize the automatic ARM training to automatically repeat in specific intervals (ie 10 minutes) if the patient has to wait for access to the procedure room. This will help promote the just learned response.

In addition to successfully completing automated ARM training, the patient's parameters must be in an acceptable range, step 1205. Personnel must determine what an acceptable range is by entering this information into the BMU 300 using the BMU GUI 212. If one of the monitored parameters fall outside a given range, the patient will not be allowed to undergo a procedure until a caregiver or other has examined the patient to determine whether or not the patient can proceed, step 1205-A. If the caregiver or other determines that the patient can continue, the patient will proceed to step 1211. If the caregiver determines that the patient cannot continue, the procedure is canceled, step 1213. Just before leaving the pre-procedure room and moving into the procedure room, the caregiver administers a predetermined low dose of an analgesic drug, step 1211, such as, for example, 1.5 mcg/kg Fentanyl. After the injection of this analgesic drug, the patient will be ready to be transferred to the procedure room, step 1212.

The patient and BMU 300 are moved to the procedure room, step 1220 and received by the doctor

(non-anaesthetist) and the procedure nurse. The BMU 300 may be connected to the PRU 200 via the umbilical cable 160 once the patient has been brought into the procedure room, step 1221. After such connection, NIBP, pulse and oximetry history from the patient will automatically be uploaded to the PRU 200 showing the patient history for the last monitoring period . In addition to the NIBP and pulse oximeter history, a record verifying that the patient has completed ARM training will also be uploaded. After a connection between the BMU 300 and the PRU 200, the BMU GUI 212 will transition from a monitoring screen to a remote input screen for the PRU 200. Screen information from the BMU 300 is automatically transferred to the PRU 200.

Now the procedure nurse can attach the oral/nasal cannula 145 to the patient's face, step 1222, if the cannula is not already set in place in the pre-procedure room. PRU 200 can start monitoring patient parameters, such as ARM, ECG and capnography now that all connections between the patient and PRU 200 (via BMU 300) are provided, step 1223. PRU 200 will continue to monitor patient parameters such as, for example, NIBP, pulse and oximetry, step 1224. Now the procedural nurse can scan the bar code marking on the drug cartridge 251 package and place the drug cartridge in the PRU 200. A standard drug vial is placed on the vial spike 261 in step 1225. Once the vial and drug cartridge 64 are properly seated, the nurse can autoprime the IV hose 259.1 one embodiment, the procedure attendant will press a button on the PRU 200 to initiate the autopriming, step 1227, or the autopriming may be an automatic procedure initiated by the PRU 200 when all safety conditions are satisfied. Autopriming is an automatic purge of air from the IV line 259. The PRU 200 will continuously monitor the autopriming to determine whether it has been successful. If the PRU 200 does not carry out a proper flush of the IV tube 259, the user will receive a notification of this so that the procedure nurse can repeat the autopriming until the IV tube 259 has been properly flushed, step 1227.

In the event of a successful autopriming, the procedure nurse will enter the patient's weight in kilograms at the same time that the physician (non-anesthesiologist) can enter the initial drug maintenance dose rate as well as a dose method, normal or rapid infusion, step 1229. After the patient's weight and dose rate are entered in, the doctor or the procedure nurse can start the drug infusion, step 1230. While the drug is starting to work on the patient, the doctor can carry out standard procedure-related activities such as, for example, carrying out a test of the area, and optionally applying a topical anaesthesia. As soon as the drug has produced the desired effect on the patient, the physician and the procedure nurse can perform the procedure, step 1231. After completing the procedure, one of the personnel can detach the drug delivery cartridge from the catheter, step 1232 and disconnect the BMU 300 from the PRU 200, step 1233 If the person concerned so wishes, the PRU 200 can print a record of the patient's physiological parameters in a printer 454, step 1234. Included in such a printout of the procedure records will be patient monitoring data, such as, for example, NIPB, pulse oximetry, capnography, respiratory rate and heart rot. Other system events in the printout are ARM competency, ARM response during the procedure, oxygen delivery history, drug dose, monitoring intervals, drug bolus amounts and time, and the total drug volume delivered during the procedure. This printout includes a section where the procedure nurse can make notes, such as, for example, that extra drugs have been delivered, topical sprays have been used, Ramsey Sedation Scale, procedure start and end time, cauterization device and settings that have been used, cauterization site, type and dimension of dilation equipment and Aldrete Score. After printing the patient registration, the patient can be moved into the convalescent room, step 1235.

When the patient enters the convalescent room 1240, that person will still be connected to the BMU 300. The BMU 300 can now use battery power or alternating current. After the patient enters the room, an assistant may remove the ECG pads, ECG leads, ARM handset, and earplug from the patient, 1241. Depending on the physician's preference and the patient's status, the patient may require supplemental oxygen while in the the convalescent room, 1242. If the patient needs additional oxygen supply, the oral/nasal cannula 145 can remain on the patient's face, and oxygen can be delivered from an external source, for example a wall head or a container, via the connector 152 and the BMU connector 151, step 1243. If if there is no need for extra oxygen in the convalescent room, the nurse or technician can remove the oral/nasal cannula 145 from the patient, 1244.

The caregiver or technician can now organize the ECG leads 334 and the ARM handset 342 and place these near the BMU 300, ready for use by the next patient, 1245. Alternatively, the ARM handset 342 can be used for the patient for time-based response to questions/requests from the ARM. The nurse or technician may need to enter additional information in the patient's registration, 1246. The nurse or technician will most likely write notes regarding the patient's condition during convalescence and record NIBP, pulse rate and oximetry values for the patient during convalescence. ECG pads 332 and the oral/nasal cannula 145 can at this point be disposed of in a regular waste receptacle in the room, 1247. It is important to be aware that the BMU 300 is still collecting data relating to NIBP, pulse rate, and pulse oximetry, 1248 The nurse or technician must decide whether the patient is ready to leave post-room 1249. Criteria for such leaving/discharge may vary in different health measures, but an Alderate score of 10 is common. Other measures for discharge criteria include a response to questions via ARM, skin color, pain assessment, intact IV site, NIBP, pulse, respiratory rate and oximetry values, all of which must be close to the measurements taken during the pre-procedure. If the patient does not meet any of these criteria, it is recommended that the patient undergo additional monitoring, 1248. Once a patient is ready for discharge, the nurse or technician will remove the NIBP cuff 58, the pulse oximeter probe, and if not already removed, also the oral/nasal cannula 145 and the ARM handset 342 from the patient, 1250. Once all of this is done, the patient can be discharged from the healthcare facility, 1251.

Reference should now be made to fig. 81. A peripheral medical display 1252 receives processed patient data from the medical effector system 100' and displays this processed patient data on the peripheral LCD display 1253. The displayed information may include heart rate, blood pressure, pulse oximetry, capnography, electrocardiogram and other medical parameters that have been treated in the medical effector system 100'. In addition to the patient data, the peripheral medical display 1252 may display procedural parameters relating to the function of the medical effector system 100'. Such functional parameters may include battery charge level, the duration of the current procedure, the patient's name and other descriptive patient data, information regarding the IV pump module 220, the pharmaceutical drug that the patient has received, and other parameters. The peripheral medical display 1252 further provides an opportunity for the physician to enter predetermined parameter limits, which if exceeded, will result in an alarm on the display 1252, in addition to an alarm that may be generated in the medical effector system 100'. The alarm can be in the form of flashing light from a peripheral light element 1254, an audio signal from a peripheral speaker 1255, or an alarm that appears on the peripheral LCD touch screen 1253.

The peripheral medical display 1252 can also display output signals from other medical devices, such as an endoscopy camera, 1256. The peripheral medical display 1252 can display the output signal from the endoscopy camera 1256 simultaneously with patient and procedure data on the peripheral LCD touch screen 1253. This enables the physician can study relevant patient and procedure data without taking their attention away from the output signal from the endoscopy camera.

The peripheral medical display 1252 may also include a user interface that enables the physician to change display settings on the display 1252. A user interface may be in the form of a PRU monitor touch screen 443 or a peripheral monitor LCD touch screen 1253 provided on the peripheral medical display 1252. With the user interface, the doctor can change various visual parameters, including making a choice of which medical parameters and procedural parameters, if any, should be added to the output signal from the endoscopy camera. Furthermore, the doctor can modify the size and position of the parameter displays in relation to each other. Other possibilities that the user interface provides are to be able to choose the screen format or medical parameters (bar graph, caliber, histogram, image or numerical), color adjustment, creation of an automatic change of visual parameters, creation of priority displays in the case of an alarm, magnification of the output signal from the endoscopy camera and selection of an alternative video source, as well as other visual possibilities. Patient and procedure parameters can be placed separately from the output signal from the endoscopy camera 1256 or can be superimposed on this output signal. This is achieved with a video mixing device arranged either in the peripheral medical display 1252 or in the medical effector system 100'. A similar peripheral medical display 1252 may use a picture-in-picture display that includes the output signal from the endoscopy camera 1256 or other video source.

Although aspects, embodiments and examples have been described above, these are not intended to limit the invention. One can imagine many variants, changes and substitutions that those skilled in the art will be able to find on the basis of the present description. For example, the medical effector system and components thereof could be used in robot-assisted surgery, provided that obvious modifications and components are taken into account in order for the system to be compatible with such a robot system. The scope of the invention is determined by the patent claims.

Claims (17)

1. Medical effector system characterized by including: a) a microprocessor-based bedside monitoring unit (300) with a bedside monitoring unit host controller (301) and having a first series of connection points for receiving patient input signals from patient monitoring connections, and a second series of connection points for delivering patient output signals based on the received input signals, and with a display screen for displaying at least some of the patient output signals, b) a microprocessor-based procedure room unit (200) with a medical effector and with a drug delivery flow control device (220') and with a procedure room unit host controller (204) with a memory containing a patient monitoring and end effector program operatively connected to the program input signals based at least in part on at least some of the patient output signals, and which controls and/or directs a user to control the medical effector based at least in part on p the roframe input signals, the procedure room unit (200), PRU, having an individual PRU identifier and the bedside monitoring unit (300), BMU, having an individual BMU identifier and c) an umbilical cable (160) having a first end connected or connectable thereto second series of connection points on the bedside monitoring unit (300) and with a second end connected or connectable to the procedure room unit (200), at least one of the first and second ends being releasable from the associated bedside monitoring unit (300) or procedure room unit ( 200), the procedure room unit host controller (204) and the bedside monitoring unit host controller (301) being operatively connected to each other when the umbilical cable (160) is connected to the procedure room unit (200) and the bedside monitoring unit (300). 2. Medical effector system according to claim 1, characterized in that the drug delivery flow control device (220') includes a drug delivery infusion pump device (220). 3. Medical effector system according to claim 1, characterized in that the procedure room unit host controller (204) shuts down the drug delivery infusion pump device (220) when certain errors are detected in an associated bedside monitoring unit (300) and/or in the procedure room unit. 4. Medical effector system according to claim 1, characterized in that the procedure room unit host controller (204) in the procedure room unit sets up an electronic history for the bedside monitoring unit (300) when it is associated with the procedure room unit, based on the individual BMU identifier. 5. Medical effector system according to claim 4, characterized in that it also includes a single patient drug delivery cartridge device (251) with an individual cartridge identifier and operatively connectable to the drug delivery flow control device (220') in the procedure room unit (200), and further includes a single patient- needle device (145) with an individual needle identifier and connectable to the bedside monitoring unit (300), the procedure room unit host controller (204) in the procedure room unit (200) establishing an electronic history of the drug delivery cassette device (251) and the needle device (145) based on the individual cartridge and needle identifiers. 6. Medical effector system according to claim 5, characterized in that the individual cassette identifier in the drug delivery cassette device (251) is a unique barcode on a sterile package containing the drug delivery cassette device (251), and/or a barcode on the drug delivery cassette device (251). 7. Medical effector system according to claim 5, characterized in that the individual needle device identifier for the needle device (145) is a unique barcode on a sterile package containing the needle device (145), and/or a barcode on the needle device (145). 8. Medical effector system according to claim 5, characterized in that the bedside monitoring unit (300) is connectable to the procedure room unit (200), the electronic history of the drug delivery cassette device (251) and/or the needle identifier becoming the needle device (145) based on the individual cassette and the needle identifier is sent from the procedure room unit (200) to the bedside monitoring unit (300). 9. Medical effector system according to claim 4, characterized in that it also includes a single patient drug vial (250) with an individual drug vial identifier and operatively connectable to the drug delivery flow control device (220') in the procedure room unit (200), the procedure room unit host controller (204) in the procedure room unit (200) sets up an electronic history for the drug vial (250) based on the individual drug vial identifiers. 10. Medical effector system according to claim 9, characterized in that the individual vial identifier for the drug vial (250) is a unique barcode on a sterile package containing the drug vial (250), and/or a barcode on the drug vial (250). 11. Medical effector system according to claim 9, characterized in that the bedside monitoring unit (300) is connectable to the procedure room unit (200), and the electronic history of the needle identifier is sent from the procedure room unit (200) to the bedside monitoring unit (300). 12. Medical effector system according to claim 1, characterized in that when the bedside monitoring unit (300) is connected to the procedure room unit (200), the bedside monitoring unit host controller (301) of a switched on bedside monitoring unit (300) will switch on a switched off procedure room unit (200). 13. Medical effector system according to claim 12, characterized in that when the bedside monitoring unit (300) is connected to the procedure room unit (200), the procedure room unit host controller (204) of a switched on procedure room unit (200) will switch on a switched off bedside monitoring unit (300). 14. Medical effector system according to claim 1, characterized in that when the bedside monitoring unit (300) is connected to the procedure room unit (200), the procedure room unit host controller (204) of a switched on procedure room unit (200) will switch on a switched off bedside monitoring unit (300). 15. Medical effector system according to claim 1, characterized in that the bedside monitoring unit (300) displays the patient monitoring when it is not connected to the procedure room unit (200), and displays the patient monitoring when it is connected to the procedure room unit (200) and the procedure room unit host controller (204) detects certain errors in the procedure room unit ( 200). 16. Medical effector system according to claim 11, characterized in that the umbilical cable (160) includes an energy supply line, and that the procedure room unit host controller (204) shuts off the energy supply in the energy supply line to the umbilical cable (160) when the umbilical cable is disconnected from the bedside monitoring unit (300) and/or the umbilical cable is disconnected from the procedure room unit (200). 17. Medical effector system according to claim 16, characterized in that the bedside monitoring unit (300) includes a bedside monitoring unit battery (303) and that energy from the procedure room unit (200) charges the bedside monitoring unit battery (303) via the power supply line to the umbilical cable (160).