US20100022875A1 - Systems and methods for monitoring and enabling use of a medical instrument - Google Patents

Abstract

Systems and methods monitor and enable the use of a medical instrument that is configured to be operated in a prescribed manner. The systems and methods employ a use register sized and configured to be carried by the medical instrument, which comprises a memory field for recording a start date and time at an instance of first operation of the medical instrument. The systems and methods also employ a use monitoring controller, which is adapted and configured to be coupled to the use register. The use monitoring controller includes a start validation function that compares the start date and time to a present real date and time and provides a start validation output based upon the comparison. The use monitoring controller also includes an enablement function that enables operation of the medical instrument only if the start validation output meets prescribed criteria.

Description

RELATED APPLICATION
• This application is a continuation of co-pending application Ser. No. 11/825,873 filed on 10 Jul. 2007, which is is a divisional of application Ser. No. 10/202,447 filed on 24 Jul. 2002 (now U.S. Pat. No. 7,241,270), which is a continuation-in-part of application Ser. No. 09/935,908, filed Aug. 23, 2001 (now ABN), which is a continuation-in-part of application Ser. No. 09/645,662, filed Aug. 24, 2000 (Now ABN), and entitled “Systems and Methods for Enhancing Blood Perfusion Using Ultrasound Energy,” which are incorporated herein by reference.
FIELD OF THE INVENTION
• This invention relates to systems and methods for increasing blood perfusion, e.g., in the treatment of myocardial infarction, strokes, and vascular diseases.
BACKGROUND OF THE INVENTION
• High frequency (5 MHz to 7 MHz) ultrasound has been widely used for diagnostic purposes. Potential therapeutic uses for ultrasound have also been more recently suggested. For example, it has been suggested that high power, lower frequency ultrasound can be focused upon a blood clot to cause it to break apart and dissolve. The interaction between lower frequency ultrasound in the presence of a thrombolytic agent has also been observed to assist in the breakdown or dissolution of thrombi. The effects of ultrasound upon enhanced blood perfusion have also been observed.
• While the therapeutic potential of these uses for ultrasound has been recognized, their clinical promise has yet to be fully realized. Treatment modalities that can apply ultrasound in a therapeutic way are designed with the premise that they will be operated by trained medical personnel in a conventional fixed-site medical setting. They assume the presence of trained medical personnel in a non-mobile environment, where electrical service is always available. Still, people typically experience the effects of impaired blood perfusion suddenly in public and private settings. These people in need must be transported from the public or private settings to the fixed-site medical facility before ultrasonic treatment modalities can begin. Treatment time (which is often critical in the early stages of impaired blood perfusion) is lost as transportation occurs. Even within the fixed-site medical facility, people undergoing treatment need to be moved from one care unit to another. Ultrasonic treatment modalities must be suspended while the person is moved.
SUMMARY OF THE INVENTION
• The invention provides systems and methods that monitor and enable the use of a medical instrument that is configured to be operated in a prescribed manner.
• According to one aspect of the invention, the systems and methods employ a use register sized and configured to be carried by the medical instrument, which comprises a memory field for recording a start date and time at an instance of first operation of the medical instrument. The systems and methods also employ a use monitoring controller, which is adapted and configured to be coupled to the use register. The use monitoring controller includes a start validation function that compares the start date and time to a present real date and time and provides a start validation output based upon the comparison. The use monitoring controller also includes an enablement function that enables operation of the medical instrument only if the start validation output meets prescribed criteria.
• According to another aspect of the invention, the systems and methods comprise a use register that is sized and configured to be carried by the medical instrument. The use register comprises a memory field for recording a prescribed copyright notice. The systems and methods also include a use monitoring controller that is adapted and configured to be coupled to the use register. The use monitoring controller includes a copyright validation function that assesses the contents of the memory field and provides a copyright validation output based upon the assessment. The use monitoring controller also includes an enablement function that enables operation of the medical instrument only if the copyright validation output meets prescribed criteria.
• In one embodiment, the medical instrument comprises an ultrasound energy applicator that includes an ultrasound transducer adapted and configured to be coupled to an ultrasound generator for operation. In this embodiment, the use register is sized and configured to be carried by the ultrasound applicator.
• Other features and advantages of the inventions are set forth in the following specification and attached drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a perspective view of a system for transcutaneously applying ultrasound energy to affect increased blood perfusion.
• FIG. 2 is an enlarged exploded perspective view of an ultrasound applicator that forms a part of the system shown inFIG. 1.
• FIG. 3 is an enlarged assembled perspective view of the ultrasound applicator shown inFIG. 2.
• FIG. 4 is a side section view of the acoustic contact area of the ultrasound applicator shown inFIG. 2.
• FIG. 5 is a view of the applicator shown inFIG. 2 held by a stabilization assembly in a secure position overlaying the sternum of a patient, to transcutaneously direct ultrasonic energy, e.g., toward the vasculature of the heart.
• FIG. 6 is a side elevation view, with portions broken away and in section, of an acoustic stack that can be incorporated into the applicator shown inFIG. 2.
• FIG. 7 is a side elevation view, with portions broken away and in section, of an acoustic stack that can be incorporated into the applicator shown inFIG. 2.
• FIG. 8ato8cgraphically depict the technical features of a frequency tuning function that the system shown inFIG. 1 can incorporate.
• FIG. 9 graphically depicts the technical features of a power ramping function that the system shown inFIG. 1 can incorporate.
• FIG. 10 is a schematic view of a controller that the system shown inFIG. 1 can incorporate, which includes a frequency tuning function, a power ramping function, an output power control function, and a use monitoring function.
• FIG. 11 is a diagrammatic view of a use register chip that forms a part of the use monitoring function shown inFIG. 10.
• FIG. 12 is a diagrammatic flow chart showing the technical features of the use monitoring function shown inFIG. 10.
• The invention may be embodied in several forms without departing from its spirit or essential characteristics. The scope of the invention is defined in the appended claims, rather than in the specific description preceding them. All embodiments that fall within the meaning and range of equivalency of the claims are therefore intended to be embraced by the claims.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
• The various aspects of the invention will be described in connection with the therapeutic indication of providing increased blood perfusion by the transcutaneous application of ultrasonic energy. That is because the features and advantages of the invention are well suited to this therapeutic indication. Still, it should be appreciated that many aspects of the invention can be applied to achieve other diagnostic or therapeutic objectives as well.
• Furthermore, in describing the various aspects of the invention in the context of the illustrated embodiment, the region targeted for an increase in blood perfusion is the thoracic cavity (i.e., the space where the heart and lungs are contained). It should be appreciated, however, that the features of invention have application in other regions of the body, too, for example, in the arms, legs, or brain.
I. System for Providing Noninvasive Ultrasound-Assisted Blood Perfusion
• FIG. 1 schematically shows a compact, portabletherapeutic system10 that makes it possible to treat a person who needs or who is likely to need an increase in the flow rate or perfusion of circulating blood.
• Thesystem10 includes durable and disposable equipment and materials necessary to treat the person at a designated treatment location. In use, thesystem10 affects increased blood perfusion by transcutaneously applying ultrasonic energy.
• AsFIG. 1 shows, thesystem10 includes at the treatment location anultrasound generating machine16. Thesystem10 also includes at the treatment location at least oneultrasound applicator18, which is coupled to themachine16 during use. AsFIG. 5 shows, thesystem10 also includes anassembly12 for use with theapplicator18 to stabilize the position of theapplicator18 on a patient for hands-free use. In the illustrated embodiment (seeFIG. 5), theapplicator18 is secured against movement on a person's thorax, overlaying the sternum, to direct ultrasonic energy toward the vasculature of the heart.
• The location where treatment occurs can vary. It can be a traditional clinical setting, where support and assistance by one or more medically trained care givers are immediately available to the person, such as inside a hospital, e.g., in an emergency room, catheter lab, operating room, or critical care unit. However, due to the purposeful design of thesystem10, the location need not be confined to a traditional clinical setting. The location can comprise a mobile setting, such as an ambulance, helicopter, airplane, or like vehicle used to convey the person to a hospital or another clinical treatment center. The location can even comprise an everyday, public setting, such as on a cruise ship, or at a sports stadium or airport, or a private setting, such as in a person's home, where the effects of low blood perfusion can arise.
• By purposeful design of durable and disposable equipment, thesystem10 can make it possible to initiate treatment of a reduced blood perfusion incident in a non-clinical, even mobile location, outside a traditional medical setting. The system thereby makes effective use of the critical time period before the person enters a hospital or another traditional medical treatment center.
• The features and operation of thesystem10 will now be described in greater detail.
• A. The Ultrasound Generator
• FIG. 1 shows a representative embodiment of theultrasound generating machine16. Themachine16 can also be called an “ultrasound generator.” Themachine16 is intended to be a durable item capable of long term, maintenance free use.
• As shown inFIG. 1, themachine16 can be variously sized and shaped to present a lightweight and portable unit, presenting a compact footprint suited for transport. Themachine16 can be sized and shaped to be mounted at bedside, or to be placed on a table top or otherwise occupy a relatively small surface area. This allows themachine16 to travel with the patient within an ambulance, airplane, helicopter, or other transport vehicle where space is at a premium. This also makes possible the placement of themachine16 in a non-obtrusive way within a private home setting, such as for the treatment of chronic angina.
• In the illustrated embodiment, themachine16 includes achassis22, which, for example, can be made of molded plastic or metal or both. Thechassis22 houses amodule24 for generating electric signals. The signals are conveyed to theapplicator18 by aninterconnect30 to be transformed into ultrasonic energy. Acontroller26, also housed within the chassis22 (but which could be external of thechassis22, if desired), is coupled to themodule24 to govern the operation of themodule24. Further desirable technical features of thecontroller26 will be described later.
• Themachine16 also preferably includes anoperator interface28. Using theinterface28, the operator inputs information to thecontroller26 to affect the operating mode of themodule24. Through theinterface28, thecontroller26 also outputs status information for viewing by the operator. Theinterface28 can provide a visual readout, printer output, or an electronic copy of selected information regarding the treatment. Theinterface28 is shown as being carried on thechassis22, but it could be located external of thechassis22 as well.
• Themachine16 includes apower cord14 for coupling to a conventional electrical outlet, to provide operating power to themachine16. Themachine16 can also include a battery module (not shown) housed within thechassis22, which enables use of themachine16 in the absence or interruption of electrical service. The battery module can comprise rechargeable batteries, that can be built in thechassis22 or, alternatively, be removed from thechassis22 for recharge. Likewise, the battery module (or themachine16 itself) can include a built-in or removable battery recharger. Alternatively, the battery module can comprise disposable batteries, which can be removed for replacement.
• Power for themachine16 can also be supplied by an external battery and/or line power module outside thechassis22. The battery and/or line power module is releasably coupled at time of use to the components within thechassis22, e.g., via a power distribution module within thechassis22.
• The provision of battery power for themachine16 frees themachine16 from the confines surrounding use of conventional ultrasound equipment, caused by their dependency upon electrical service. This feature makes it possible for themachine16 to provide a treatment modality that continuously “follows the patient,” as the patient is being transported inside a patient transport vehicle, or as the patient is being shuttled between different locations within a treatment facility, e.g., from the emergency room to a holding area within or outside the emergency room.
• In a representative embodiment, thechassis22 measures about 12 inches×about 8 inches×about 8 inches and weighs about 9 pounds.
• B. The Ultrasound Applicator
• As shown inFIG. 5, theapplicator18 can also be called the “patient interface.” Theapplicator18 comprises the link between themachine16 and the treatment site within the thoracic cavity of the person undergoing treatment. Theapplicator18 converts electrical signals from themachine16 to ultrasonic energy, and further directs the ultrasonic energy to the targeted treatment site.
• Desirably, theapplicator18 is intended to be a disposable item. At least oneapplicator18 is coupled to themachine16 via theinterconnect30 at the beginning a treatment session. Theapplicator18 is preferably decoupled from the interconnect30 (asFIG. 1 shows) and discarded upon the completing the treatment session. However, if desired, theapplicator18 can be designed to accommodate more than a single use.
• AsFIGS. 2 and 3 show, theultrasound applicator18 includes a shaped metal orplastic body38 ergonomically sized to be comfortably grasped and manipulated in one hand. Thebody38 houses and supports at least one ultrasound transducer40 (seeFIG. 3).
• In the illustrated embodiment, theultrasound transducer40 comprises anacoustic stack20. Theacoustic stack20 comprises afront mass piece32, aback mass piece34, and one or morepiezoelctric elements36, which are bolted together. Theback mass piece34 comprises an annular ring of material having relatively high acoustic impedance, e.g., steel or stainless steel. “Acoustic impedance” is defined as the product of the density of the material and the speed of sound.
• Thefront mass piece32 comprises a cone-shaped piece of material having relatively low acoustic impedance, e.g., aluminum or magnesium. Thepiezoelectric elements36 are annular rings made of piezoelectric material, e.g., PZT. An internally threaded hole or the like receives abolt42 that mechanically biases theacoustic stack20. Abolt42 that can be used for this purpose is shown in U.S. Pat. No. 2,930,912. Thebolt42 can extend entirely through thefront mass piece32 or, thebolt42 can extend through only a portion of the front mass piece32 (seeFIG. 7).
• In an alternative embodiment (seeFIG. 6), theacoustic stack20′ of atransducer40′ can comprise a singlepiezoelectric element36′ sandwiched between front and backmass pieces32′ and34′. In this arrangement, theback mass piece34′ is electrically insulated from thefront mass piece32′ by, e.g., an insulating sleeve andwasher44.
• The piezoelectric element(s)36/36′ have electrodes46 (seeFIG. 2) on major positive and negative flat surfaces. Theelectrodes46 electrically connect theaccoustic stack20 of thetransducer40 to the electricalsignal generating module24 of themachine16. When electrical energy at an appropriate frequency is applied to theelectrodes46, thepiezoelectric elements36/36′ convert the electrical energy into mechanical (i.e., ultrasonic) energy in the form of mechanical vibration.
• The mechanical vibration created by thetransducer40/40′ is coupled to a patient through atransducer bladder48, which rests on a skin surface. Thebladder48 defines a bladder chamber50 (seeFIG. 4) between it and thefront mass piece32. Thebladder chamber50 spaces the front mass piece32 a set distance from the patient's skin. Thebladder chamber50 accommodates a volume of an acoustic coupling media liquid, e.g., liquid, gel, oil, or polymer, that is conductive to ultrasonic energy, to further cushion the contact between theapplicator18 and the skin. The presence of the acoustic coupling media also makes the acoustic contact area of thebladder48 more conforming to the local skin topography.
• Desirably, an acoustic coupling medium is also applied between thebladder48 and the skin surface. The coupling medium can comprise, e.g., a gel material (such as AQUASONIC® 100, by Parker Laboratories, Inc., Fairfield, N.J.). The external material can possess sticky or tacky properties, to further enhance the securement of theapplicator18 to the skin.
• In the illustrated embodiment, thebladder48 andbladder chamber50 together form an integrated part of theapplicator18. Alternatively, thebladder48 andbladder chamber50 can be formed by a separate molded component, e.g., a gel or liquid filled pad, which is supplied separately. A molded gel filled pad adaptable to this purpose is the AQUAFLEX® Ultrasound Gel Pad sold by Parker Laboratories (Fairfield, N.J.).
• In a representative embodiment, thefront mass piece32 of theacoustic stack20 measures about 2 inches in diameter, whereas the acoustic contact area formed by thebladder48 measures about 4 inches in diameter. Anapplicator18 that presents an acoustic contact area of larger diameter than thefront mass piece32 of thetransducer40 makes possible an ergonomic geometry that enables single-handed manipulation during set-up, even in confined quarters, and further provides (with the assembly12) hands-free stability during use. In a representative embodiment, theapplicator18 measures about 4 inches in diameter about thebladder48, about 4 inches in height, and weighs about one pound.
• An O-ring52 (seeFIG. 4) is captured within agroove54 in thebody38 of theapplicator18 and agroove84 on thefront mass piece32 of thetransducer40. The o-ring52 seals thebladder chamber50 and prevents liquid in thechamber50 from contacting the sides of thefront mass piece32. Thus, asFIG. 4 shows, only the outer surface of thefront mass piece32 is in contact with the acoustic coupling medium within thechamber50.
• Desirably, the material of the O-ring52 is selected to possess elasticity sufficient to allow theacoustic stack20 of thetransducer40 to vibrate freely in a piston-like fashion within thetransducer body38. Still, the material of the O-ring52 is selected to be sturdy enough to prevent theacoustic stack20, while vibrating, from popping out of thegrooves54 and84.
• In a representative embodiment, the O-ring52 is formed from nitrile rubber (Buna-N) having a hardness of about 30 Shore A to about 100 Shore A. Preferably, the O-ring52 has a hardness of about 65 Shore A to about 75 Shore A.
• Thebladder48 is stretched across the face of thebladder chamber50 and is preferably also locked in place with another O-ring56 (seeFIG. 4). A membrane ring may also be used to prevent the O-ring56 from popping loose. The membrane ring desirably has a layer or layers of soft material (e.g., foam) for contacting the skin.
• Localized skin surface heating effects may arise by the presence of air bubbles trapped between the acoustic contact area (i.e., the surface of the bladder48) and the individual's skin. In the presence of ultrasonic energy, the air bubbles vibrate, and thereby may cause cavitation and attendant conductive heating effects at the skin surface. To minimize the collection of air bubbles along the acoustic contact area, thebladder48 desirably presents a flexible, essentially flat radiating surface contour where it contacts the individual's skin (seeFIG. 4), or a flexible, outwardly bowed or convex radiating surface contour(i.e., curved away from the front mass piece) where it contacts with or conducts acoustic energy to the individual's skin. Either a flexible flat or convex surface contour can “mold” evenly to the individuals skin topography, to thereby mediate against the collection and concentration of air bubbles in the contact area where skin contact occurs.
• To further mediate against cavitation-caused localized skin surface heating, the interior of thebladder chamber50 can include a recessedwell region58 surrounding thefront mass piece32. Thewell region58 is located at a higher gravity position than the plane of thefront mass piece32. Air bubbles that may form in fluid located in thebladder chamber50 are led by gravity to collect in thewell region58 away from the ultrasonic energy beam path.
• Thefront mass piece32 desirably possesses either a flat radiating surface (asFIG. 4 shows) or a convex radiating surface (asFIG. 7 shows). The convex radiation surface directs air bubbles off the radiating surface. The radiating surface of the front mass piece may also be coated with a hydrophilic material60 (seeFIG. 4) to prevent air bubbles from sticking.
• Thetransducer40 may also include a reflux valve/liquid inlet port62.
• Theinterconnect30 carries a distal connector80 (seeFIG. 2), designed to easily plug into a mating outlet in theapplicator18. Aproximal connector82 on theinterconnect30 likewise easily plugs into a mating outlet on the chassis22 (seeFIG. 1), which is itself coupled to thecontroller26. In this way, theapplicator18 can be quickly connected to themachine16 at time of use, and likewise quickly disconnected for discard once the treatment session is over. Other quick-connect coupling mechanisms can be used. It should also be appreciated that theinterconnect30 can be hard wired as an integrated component to theapplicator18 with a proximal quick-connector to plug into thechassis22, or, vice versa, theinterconnect30 can be hard wired as an integrated component to thechassis22 with a distal quick-connector to plug into theapplicator18.
• AsFIG. 5 shows, thestabilization assembly12 allows the operator to temporarily but securely mount theapplicator18 against an exterior skin surface for use. In the illustrated embodiment, since the treatment site exists in the thoracic cavity, theattachment assembly54 is fashioned to secure theapplicator18 on the person's thorax, overlaying the sternum or breastbone, asFIG. 5 shows.
• Theassembly12 can be variously constructed. As shown inFIG. 5, theassembly12 comprisesstraps90 that pass throughbrackets92 carried by theapplicator18. Thestraps90 encircle the patient's neck and abdomen.
• Just as theapplicator18 can be quickly coupled to themachine16 at time of use, thestabilization assembly12 also preferably makes the task of securing and removing theapplicator18 on the patient simple and intuitive. Thus, thestabilization assembly12 makes it possible to secure theapplicator18 quickly and accurately in position on the patient in cramped quarters or while the person (and thesystem10 itself) is in transit.
• Desirably, when used to apply ultrasonic energy transcutaneously in the thoracic cavity to the heart, thefront mass piece32 is sized to deliver ultrasonic energy in a desired range of fundamental frequencies to substantially the entire targeted region (e.g., the heart). Generally speaking, the fundamental frequencies of ultrasonic energy suited for transcutaneous delivery to the heart in the thoracic cavity to increase blood perfusion can lay in the range of about 500 kHz or less. Desirably, the fundamental frequencies for this indication lay in a frequency range of about 20 kHz to about 100 kHz, e.g., about 27 kHz.
II. Controlling the Application of Ultrasound Energy
• To achieve the optimal application of ultrasound energy and the optimal therapeutic effect, the application of ultrasound energy should desirably incorporate one or more of the following features: (1) choice, or tuning, of the output frequency, (2) power ramping, (3) output power control, and (4) pulsed power.
• A. Tuning of Output Frequency
• Depending upon the treatment parameters and outcome desired, thecontroller26 can operate a giventransducer40 at a fundamental frequency below about 50 kHz, or in a fundamental frequency range between about 50 kHz and about 1 MHz, or at fundamental frequencies above 1 MHz.
• A giventransducer40 can be operated in either a pulsed or a continuous mode, or in a hybrid mode where both pulsed and continuous operation occurs in a determined or random sequence at one or more fundamental frequencies.
• Theapplicator18 can include multiple transducers40 (ormultiple applicators18 can be employed simultaneously for the same effect), which can be individually conditioned by thecontroller26 for operation in either pulsed or continuous mode, or both. For example, themultiple transducers40 can all be conditioned by thecontroller26 for pulsed mode operation, either individually or in overlapping synchrony. Alternatively, themultiple transducers40 can all be conditioned by thecontroller26 for continuous mode operation, either individually or in overlapping synchrony. Still alternatively, themultiple transducers40 can be conditioned by thecontroller26 for both pulsed and continuous mode operation, either individually or in overlapping synchrony.
• One ormore transducers40 within an array oftransducers40 can also be operated at different fundamental frequencies. For example, one ormore transducers40 can be operated at about 25 kHz, while another one ormore transducers40 can be operated at about 100 kHz. More than two different fundamental frequencies can be used, e.g., about 25 kHz, about 50 kHz, and about 100 kHz.
• Operation at different fundamental frequencies provides different effects. For example, given the same power level, at about 25 kHz, more cavitation effects are observed to dominate, while above 500 kHz, more heating effects are observed to dominate.
• Thecontroller26 can trigger the fundamental frequency output according to time or a physiological event (such as ECG or respiration).
• A giventransducer40 can be operated at a frequency within a certain range of frequencies suitable to thetransducer40. The optimal frequency for a given treatment is dependent on a number of factors, e.g., the magnitude of the fill volume of thebladder chamber50; the characteristics of the acoustic coupling between the acoustic contact area (i.e., bladder48) and the patient's skin; the morphology of the patient (e.g., size, weight, girth) which affect the transmission of ultrasound energy through the skin and within the body; the acoustic load impedance seen by thetransducer40.
• AsFIG. 10 shows, thecontroller26 desirably includes atuning function64. Thetuning function64 selects an optimal frequency at the outset of each treatment session, taking into account at least some of the above-listed factors. In the illustrated embodiment (seeFIGS. 8A to 8C), the tuning function sweeps the output frequency within a predetermined range of frequencies (f-start to f-stop). The frequency sweep can be and desirably is done at an output power level that is lower than the output power level of treatment (seeFIG. 9). The frequency sweep can also be done in either a pulsed or a continuous mode, or in a hybrid mode. An optimal frequency of operation is selected based upon one or more parameters sensed during the sweeping operation.
• AsFIG. 8A shows, the frequency sweep can progress from a lower frequency (f-start) to a higher frequency (f-stop), or vice versa. The sweep can proceed on a linear basis (asFIG. 8A also shows), or it can proceed on a non-linear basis, e.g., logarithmically or exponentially or based upon another mathematical function. The range of the actual frequency sweep may be different from the range that is used to determine the frequency of operation. For instance, the frequency span used for the determination of the frequency of operation may be smaller than the range of the actual sweep range.
• In one frequency selection approach (seeFIGS. 8A and 8C), while sweeping frequencies, thetuning function64 adjusts the output voltage and/or current to maintain a constant output power level (p-constant). Thefunction64 also senses changes in transducer impedance (see FIG.8B)—Z-min to Z-max—throughout the frequency sweep. In this approach (seeFIG. 8B), thetuning function64 selects as the frequency of operation the frequency (f-tune) where, during the sweep, the minimum magnitude of transducer impedance (Z-min) is sensed. Typically, this is about the same as the frequency of maximum output current (I), which in turn, is about the same as the frequency of minimum output voltage (V).
• In an alternative frequency selection approach, thetuning function64 can select as the frequency of operation the frequency where, during the sweep, the maximum of real transducer impedance (z) occurs, where:
• 
  |Z|=√{square root over ((R)}²+X²)
• • and where |Z| is the absolute value of the transducer impedance (Z), which derived according to the following expression:
• 
  Z=R+iX
• • where R is the real part, and X is the imaginary part.
• In another alternative frequency selection approach, while sweeping the frequencies, thetuning function64 can maintain a constant output voltage. In this approach, thetuning function64 can select as the frequency of operation the frequency where, during the sweep, the maximum output power occurs. Alternatively, thetuning function64 can select as the frequency of operation the frequency where, during the sweep, the maximum output current occurs.
• B. Power Ramping
• As before described, thetuning function64 desirably operates an output power level lower than the output power level of treatment. In this arrangement, once the operating frequency has been selected, the output power level needs to be increased to the predetermined output level to have the desired therapeutic effect.
• In the illustrated embodiment (seeFIG. 10), thecontroller26 includes a rampingfunction66. The ramping function66 (seeFIG. 9) causes a gradual ramp up of the output power level from the power level at which thetuning function64 is conducted (e.g., 5 W) to the power level at which treatment occurs (e.g., 25 W). The gradual ramp up decreases the possibility of unwanted patient reaction to the ultrasound exposure. Further, a gradual ramp up is likely to be more comfortable to the patient than a sudden onset of the full output power.
• In a desired embodiment, the rampingfunction66 increases power at a rate of about 0.01 W/s to about 10 W/s. A particularly desired ramping rate is between about 0.1 W/s to about 5 W/s. The rampingfunction66 desirably causes the ramp up in a linear fashion (asFIG. 9 shows). However, the ramping function can employ non-linear ramping schemes, e.g., logarithmic or according to another mathematical function.
• C. Output Power Control
• Also depending upon the treatment parameters and outcome desired, thecontroller26 can operate a giventransducer40 at a prescribed power level, which can remain fixed or can be varied during the treatment session. Thecontroller26 can also operate one ormore transducers40 within an array of transducers40 (or when using multiple applicators18) at different power levels, which can remain fixed or themselves vary over time.
• The parameters affecting power output take into account the output of the signal generator module; the physical dimensions and construction of the applicator; and the physiology of the tissue region to which ultrasonic energy is being applied.
• During a given treatment session, the transducer impedance may vary due to a number of reasons, e.g., transducer heating, changes in acoustic coupling between the transducer and patient, and/or changes in the transducer bladder fill volume due to degassing and/or leaks. In the illustrated embodiment (seeFIG. 10), thecontroller26 includes an outputpower control function68. The outputpower control function68 holds the output power constant, despite changes in transducer impedance within a predetermined range. If the transducer falls out of the predetermined range, for instance, due to an open or a short circuit, thecontroller26 shutdowns thegenerator ultrasound module24 and desirably sounds an alarm.
• Governed by the outputpower control function68, as the transducer impedance increases, the output voltage is increased to hold the power output constant. Should the output voltage reach a preset maximum allowable value, the output power will decrease, provided the transducer impedance remains within its predetermined range. As the transducer impedance subsequently drops, the output power will recover, and the full output power level will be reached again.
• Governed by the outputpower control function68, as the transducer impedance decreases, the output current is increased to hold the power output constant. Should the output current reach a preset maximum allowable value, the output power will decrease until the impedance increases, again, and will allow full output power.
• In addition to the described changes in the output voltage and current to maintain a constant output power level, the outputpower control function68 can vary the frequency of operation slightly upward or downward to maintain the full output power level within the allowable current and voltage limits.
• D. Pulsed Power Mode
• The application of ultrasonic energy in a pulsed power mode can serve to reduce the localized heating effects that can arise due to operation of thetransducer40.
• During the pulsed power mode, ultrasonic energy is applied at a desired fundamental frequency or within a desired range of fundamental frequencies at the prescribed power level or range of power levels (as described above, to achieve the desired physiologic effect) in a prescribed duty cycle (DC) (or range of duty cycles) and a prescribed pulse repetition frequency (PRF) (or range of pulse repetition frequencies). Desirably, the pulse repetition frequency (PRF) is between about 20 Hz to about 50 Hz (i.e., between about 20 pulses a second to about 50 pulses a second).
• The duty cycle (DC) is equal to the pulse duration (PD) divided by one over the pulse repetition frequency (PRF). The pulse duration (PD) is the amount of time for one pulse. The pulse repetition frequency (PRF) represents the amount of time from the beginning of one pulse to the beginning of the next pulse. For example, given a pulse repetition frequency (PRF) of 30 Hz (30 pulses per second) and a duty cycle of 25% yields a pulse duration (PD) of approximately8 msec. At these settings, the system outputs an 8 msec pulse followed by a 25 msec offperiod 30 times per second.
• Given a pulse repetition frequency (PRF) selected at 25 Hz and a desired fundamental frequency of 27 kHz delivered in a power range of between about 15 to 30 watts, a duty cycle of about 50% or less meets the desired physiologic objectives in the thoracic cavity, with less incidence of localized conductive heating effects compared to a continuous application of the same fundamental frequency and power levels over a comparable period of time. Given these operating conditions, the duty cycle desirably lays in a range of between about 10% and about 35%.
III. Monitoring Use of the Transducer
• To protect patients from the potential adverse consequences occasioned by multiple use, which include disease transmission, or material stress and instability, or decreased or unpredictable performance, thecontroller26 desirably includes a use monitoring function70 (seeFIG. 10) that monitors incidence of use of a giventransducer40.
• In the illustrated embodiment, thetransducer40 carries a use register72 (seeFIG. 4). Theuse register72 is configured to record information before, during, and after a given treatment session. Theuse register72 can comprise a solid state micro-chip, ROM, EEROM, EPROM, or non volatile RAM (NVRAM) carried by thetransducer40.
• Theuse register72 is initially formatted and programmed by the manufacturer of the system to include memory fields. In the illustrated embodiment (seeFIG. 11), the memory fields of the use register are of two general types: Write Many Memory Fields74 and Write-Once Memory Fields76. The Write Many Memory Fields74 record information that can be changed during use of thetransducer40. The Write-Once Memory Fields76 record information that, once recorded, cannot be altered.
• The specific information recorded by theMemory Fields74 and76 can vary. The following table exemplifies typical types of information that can be recorded in the WriteMany Memory Fields74.

• 			Size
  Field Name	Description	Location	(Byte)

  Treatment	If a transducer has been	0	1
  Complete	used for a prescribed
  	maximum treatment time
  	(e.g., 60 minutes), the
  	treatment complete flag is
  	set to 1 otherwise it is
  	zero.
  Prescribed	This is the allowable usage	1-2	2
  Maximum	time of the transducer.
  Treatment	This is set by the
  Time	manufacturer and determines
  (Minutes)	at what point the Treatment
  	Complete flag is set to 1.
  Elapsed	Initialized to zero. This	3-4	2
  Usage Time	area is then incremented
  (Minutes)	every minute that the
  	system is transmitting
  	ultrasound energy. This
  	area keeps track of the
  	amount of time that the
  	transducer has been used.
  	When this time reaches the
  	Prescribed Maximum
  	Treatment Time, the
  	Treatment Complete flag is
  	set to 1.
  Transducer	This is an area that could	5-6	2
  Frequency	be used to prescribe the
  	operational frequency of
  	the transducer, rather than
  	tuning the transducer to an
  	optimal frequency, as above
  	described. In the latter
  	instance, this area shows
  	the tuned frequency once
  	the transducer has been
  	tuned.
  Average	The system reads and	7-8	2
  Power	accumulates the delivered
  (Watts)	power throughout the
  	procedure. Every minute,
  	the average power number is
  	updated in this area from
  	the system, at the same
  	time the Elapsed Usage Time
  	is updated. When the Usage
  	time clock is updated. This
  	means that the average
  	power reading could be off
  	by a maximum of 59 seconds
  	if the treatment is stopped
  	before the Treatment
  	Complete flag is set. This
  	average power can be used
  	as a check to make sure
  	that the system was running
  	at full power during the
  	procedure.
  Applicator	Use Register CRC. This	9-10	2
  CRC	desirably uses the same CRC
  	algorithm used to protect
  	the controller ROM.
  Copyright	Desirably, the name of the	11-23	11
  Notice	manufacturer is recorded in
  	this area. Other
  	information can be recorded
  	here as well.

• The on/off cycles of ultrasound transmission could affect the accuracy of the recorded power levels because of the variance of the power levels due to rampingfunction66. For this reason it may be advantageous to also record the number of on/off cycles of ultrasound transmission. This will help explain any discrepancies in the average power reading. It might also allow the identification of procedural problems with system use.
• Each use register72 can be assigned a unique serial number that could be used to track transducers in the field. This number can be read by theuse monitoring function70 if desired.
• The following table exemplifies typical types of information that can be recorded in the Write-Once Memory Fields76.

• 			Size
  	Field Name	Description	(Bytes)

  	Start Date Time	Once the system has tuned
  		the transducer and started
  		to transmit ultrasound, the
  		current date and time are
  		written to this area. This
  		area is then locked, which
  		prevents the data from
  		ever-being changed.
  	Tuned Frequency	The tuned frequency is
  		written to this location
  		when the Start Date and
  		Time is set. This prevents
  		this information from being
  		written over on subsequent
  		tunes (if necessary).

• AsFIG. 12 shows, when atransducer40 is first coupled to themachine16, and prior to enabling the conveyance of ultrasound energy to thetransducer40, theuse monitoring function70 prompts theuse register72 to output resident information recorded in the memory fields.
• Theuse monitoring function70 compares the contents of the Copyright Notice field to a prescribed content. In the illustrated embodiment, the prescribed content includes information contained in the Copyright Notice field of the WriteMany Memory Fields74. The prescribed content therefore includes the name of the manufacturer, or other indicia uniquely associated with the manufacture. If the prescribed content is missing, theuse monitoring function70 does not enable use of thetransducer40, regardless of the contents of any other memory field. Thetransducer40 is deemed “invalid.” In this way, a manufacturer can assure that only transducers meeting its design and quality control standards are operated in association with themachine16.
• If the contents of the Copyright Notice field match, theuse monitoring function70 compares the digital value residing in the Treatment Complete field of the Write Many Memory Fields74 to a set value that corresponds to a period of no prior use or a prior use less than the Prescribed Maximum Treatment Time—i.e., in the illustrated embodiment, a zero value. A different value (i.e., a 1 value) in this field indicates a period of prior use equal to or greater than the Prescribed Maximum Treatment Time. In this event, theuse monitoring function70 does not enable use of thetransducer40. Thetransducer40 is deemed “invalid.”
• If a value of zero resides in the Treatment Complete field, theuse monitoring function70 compares the date and time data residing in the Write-Once Start Date and Time field to the current date and time established by a Real Time Clock. If the Start Date and Time is more than a prescribed time before the Real Time (e.g., 4 hours), the controller does not enable use of thetransducer40. Thetransducer40 is deemed “invalid.”
• If the Start Date and Time field is empty, or if it is less than the prescribed time before the Real Time, theuse monitoring function70 deems thetransducer40 to be “valid” (providing the preceding other criteria have been met). Theuse monitoring function70 reports a valid transducer to thecontroller26, which initiates thetuning function64. If the Start Date and Time field is empty, once the tuningfunction64 is completed, the controller prompts theuse monitoring function70 to records the current date and time in the Start Date and Time Field, as well as the selected operating frequency in the Tuned Frequency field. Thecontroller26 then proceeds to execute the rampingfunction66 and, then, execute the prescribed treatment protocol.
• If the Start Date and Time field is not empty (indicating a permitted prior use), once the tuningfunction64 is completed, thecontroller26 immediately proceeds with the rampingfunction66 and, then, execute the treatment protocol.
• During use of the transducer49 to accomplish the treatment protocol, theuse monitoring function70 periodically updates the Elapsed Usage Time field and Average Power field (along with other Many Write Memory Fields). Once the Treatment Complete flag is set to a 1 value (indicating use of the transducer beyond the Prescribed Maximum Treatment Time), theuse monitoring function70 interrupts the supply of ultrasound energy to the transducer. Thetransducer40 is deemed “invalid” for subsequent use. Theuse monitoring function70 can also generate an output that results in a visual or audible alarm, informing the operator that thetransducer40 cannot be used.
• The information recorded in theuse register72 can also be outputted to monitor use and performance of a giventransducer40. Other sensors can be used, e.g., atemperature sensor78 carried on the front mass piece32 (seeFIG. 4), in association with the use register.
• As described, theuse register72 allows specific pieces of information to be recorded before, during and after a treatment is complete. Information contained in theuse register72 is checked before allowing use of a giventransducer40. Theuse register72 ensures that only atransducer40 having the desired design and performance criteria imparted by the manufacturer can be used. In addition, theuse register72 can be used to “lock out” atransducer40 and prevent it from being used in the future. The only way thetransducer40 could be reused is to replace theuse register72 itself. However, copying the architecture of the use register72 (including the contents of the Copyright Message field required for validation) itself constitutes a violation of the manufacturer's copyright in a direct and inescapable way.
• Various features of the invention are set forth in the following claims.

Claims (1)

1. A system for monitoring and enabling use of a medical instrument that is configured to be operated in a prescribed manner, the system comprising

a use register sized and configured to be carried by the medical instrument and comprising a memory field for recording a start date and time at an instance of first operation of the medical instrument, and

a use monitoring controller adapted and configured to be coupled to the use register including a start validation function that compares the start date and time to a present real date and time and provides a start validation output based upon the comparison, and an enablement function that enables operation of the medical instrument only if the start validation output meets prescribed criteria.

Images