Systems and methods for dynamic drug therapy response to blood pressure incidents

A dermal or transdermal drug-delivery skin patch has a blood pressure sensor structurally integrated or built into it. The skin patch when attached to a skin portion of an individual determines a blood pressure of the individual and in response needle-lessly delivers a treatment drug to the individual if necessary.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is related to and claims the benefit of the earliest available effective filing date(s) from the following listed application(s) (the “Related Applications”) (e.g., claims earliest available priority dates for other than provisional patent applications or claims benefits under 35 USC §119(e) for provisional patent applications, for any and all parent, grandparent, great-grandparent, etc. applications of the Related Application(s)). All subject matter of the Related Applications and of any and all parent, grandparent, great-grandparent, etc. applications of the Related Applications is incorporated herein by reference to the extent such subject matter is not inconsistent herewith.

RELATED APPLICATIONS

1. For purposes of the USPTO extra-statutory requirements, the present application constitutes a continuation of U.S. patent application Ser. No. 13/373,364, entitled INFLATABLE CUFF WITH BUILT-IN DRUG DELIVERY DEVICE FOR DYNAMIC DRUG THERAPY RESPONSE TO BLOOD PRESSURE INCIDENTS, naming Michael H. Baym; Edward S. Boyden; Roderick A. Hyde; Jordin T. Kare; Eric C. Leuthardt; Nathan P. Myhrvold; and Lowell L. Wood, Jr. as inventors, filed on Nov. 8, 2011, which is currently co-pending, or is an application of which a currently co-pending application entitled to the benefit of the filing date.

The United States Patent Office (USPTO) has published a notice to the effect that the USPTO's computer programs require that patent applicants reference both a serial number and indicate whether an application is a continuation, continuation-in-part, or divisional of a parent application. Stephen G. Kunin,Benefit of Prior-Filed Application, USPTO Official Gazette Mar. 18, 2003. The present Applicant Entity (hereinafter “Applicant”) has provided above a specific reference to the application(s) from which priority is being claimed as recited by statute. Applicant understands that the statute is unambiguous in its specific reference language and does not require either a serial number or any characterization, such as “continuation” or “continuation-in-part,” for claiming priority to U.S. patent applications. Notwithstanding the foregoing, Applicant understands that the USPTO's computer programs have certain data entry requirements, and hence Applicant has provided designation(s) of a relationship between the present application and its parent application(s) as set forth above, but expressly points out that such designation(s) are not to be construed in any way as any type of commentary and/or admission as to whether or not the present application contains any new matter in addition to the matter of its parent application(s).

BACKGROUND

The present application relates, in general, to antihypertensive drug therapy. In particular, the application relates to controlling hypertension episodes round the clock.

Hypertension is an inevitable disease of all populations in their second half-century of life, no matter who-or-where they may be. Moreover, hypertension assertedly creeps-up linearly with time, and soon enough becomes the major cause of morbidity and mortality. Severe hypertension insidiously damages the central nervous system—even in a victim barely into his or her second half-century. See e.g., New England Journal of Medicine.

Increased blood pressures are associated with increased chances of having a stroke, heart attack, kidney failure or heart failure and a whole host of other maladies or health complications. Medical classification of hypertension is based on blood pressure ranges. An exemplary blood pressure classification in common use is as follows:

Blood Pressure Classification Table11575Desireable120-13980-89Prehypertension140-15990-99Hypertension Stage 1160 or over100 or overHypertension Stage 2

As the blood pressures rise above 115/75 there is an increased incidence of the above-mentioned complications. This increased incidence worsens as the blood pressure increases above 115/75 (i.e., mean arterial pressures above 95 mm Hg) are linearly bad. Deterioration of the vascular beds of several heavily vascularized vital organs (e.g., kidneys, heart and brain) appears to be linear with the time-integral of mean arterial pressure above a desirable threshold of 95 mm Hg. On top of general vascular bed-rot, macro problems such as various flavors of myocardial ‘remodeling’, heart failure, etc. occur.

A problem with current diagnosis and treatment of hypertension is that they are usually based on only an individual or few measurements of blood pressure without taking into account of hypertensive episodes or excursions that may contribute to a higher time-integral of mean arterial pressure above the desirable threshold of 95 mm Hg. See e.g., Powers B, et al “Measuring blood pressure for decision making and quality reporting: where and how many measures?” Ann Intern Med 2011; 154: 781-788, and Appel L, et al “Improving the measurement of blood pressure: Is it time for regulated standards?” Ann Intern Med 2011; 154: 838-839. Both of these references and all other references cited in this disclosure are incorporated by reference herein in their entireties.

Consideration is now given to ways to promptly treat blood pressure increases in an individual toward reducing the time-integral of mean arterial pressure above a desirable threshold of 95 mm Hg.

SUMMARY

Systems and methods are provided for treating blood pressure excursions in an individual. The systems and methods rely on real or near real time measurement of any blood pressure excursions in an individual and prompt drug therapy to address the blood pressure excursions.

The systems and methods involve automatically detecting when hypertension has commenced in an individual, and to promptly medicating so as to robustly suppress it. The automatic detection of is based on use of suitable sensors attached to the individual to non-invasively monitor blood pressure over extended periods of time. A sensor-informed controlled drug delivery system dispenses a physician-specified dosing of at-least-one hypertension medication into the body of the individual to maintain blood pressure(s) below physician-specified level(s).

The systems and methods provide means of hypertension-suppression to everyone in a real-time monitored-&-adjusted manner, so as to accommodate individual needs and life demands. The systems and methods provide quasi-real-time coupling between blood pressure measurement and medication in order to provide low-latency, high-authority negative feedback as blood pressure can fluctuate greatly over a time-scale of a few hours.

Throughout the figures, unless otherwise stated, the same reference numerals and characters are used to denote like features, elements, components, or portions of the illustrated embodiments.

DESCRIPTION

In the following description of exemplary embodiments, reference is made to the accompanying drawings, which form a part hereof. It will be understood that embodiments described herein are exemplary, but are not meant to be limiting. Further, it will be appreciated that the solutions described herein can be practiced or implemented by other than the described embodiments. Modified embodiments or alternate embodiments may be utilized, in the spirit and scope of the solutions described herein.

One approach is directed to automated monitoring of blood pressures and real time or near real time drug therapy upon indications of hypertension or other excursions in blood pressure values.

FIG. 1shows and exemplary device100for automated monitoring of blood pressures and real time or near real time drug therapy of hypertension. Device100includes a blood pressure sensor110coupled to a drug-delivery device120. The two are integrated together as a unit attachable to the individual (e.g., using straps or adhesive). Device100may be adapted to be attached to a skin portion of the individual and/or fully or partially implanted in the individual. Device100may include a processing circuit130configured to process blood pressure data and other data. Processing circuit130may include a memory to store one or more measured blood pressure values. Processing circuit130may also include a microprocessor programmed to execute drug-dispensing instructions based on blood pressure values.

Further, device120may include an input/output communications interface140that may, for example, be used to communicate blood pressure values, device actions and/or device status to, or receive data or instructions from an external point via the input/output communications interface. Processing circuit130/interface140may be configured to receive parameters relating drug dispensation requirements and blood pressure values, and/or other instructions from an external source.

Blood pressure sensor110is configured to make one or more ultrasonic measurements of an individual's blood pressure. Blood pressure sensor110may be battery powered. Blood pressure sensor110may be any suitable ultrasonic transducer that provides fast, accurate blood pressure readings. Sensor110may, for example, be a piezo electric transducer (such as of the type sold under the name Arterial Pressure Transducer by MTC ElectroCeramics, 232 Forbes Road, Bedford, Ohio 44146-5418 USA) or a thin film transducer (such as of the type described by Tsubai M., et al. “Development of an Ultrasonic Probe with Measurement of Contact Pressure Distribution,” SICE-ICASE, 2006. International Joint Conference, 18-21 Oct. 2006, pp. 3827-3830). Sensor110may be a Doppler ultrasound device that allows both blood flow and blood pressure to be measured. See e.g., Kazamias et al. “Blood pressure measurement with Doppler ultrasonic flowmeter,” J Appl Physiol 1971; 30:585-588. and “Toward Noninvasive Blood Pressure Assessment in Arteries by Using Ultrasound, Ultrasound in Medicine & Biology,” Volume 37, Issue 5, May 2011, pages 788-797.

In general, ultrasound sensor110may be one of a broad angle ultrasound sensor, a directed beam ultrasound sensor, a bistatic ultrasound sensor and a phased array ultrasound sensor. In a version of device100, sensor110may be configured to make Doppler measurements of a blood flow in the individual by correlating blood velocity and pressure. Sensor110may be configured to locate a blood vessel and make one or measurements of blood pressure in the located blood vessel. Further, sensor110may be configured to measure dynamic changes in a blood vessel size or elasticity that are indicative of the blood pressure. Sensor110may be configured to apply sufficient energy to jostle blood in a blood vessel or walls of the blood vessel and to measure the blood pressure response to the applied energy.

Drug delivery device120, which is responsive to sensor110is configured to dispense or apply a drug to the individual in response to the measured blood pressure. In general, drug delivery device120may configured to dispense or apply a drug to the individual in response to current, average and/or cumulative blood pressure values. In a version of device100, drug delivery device120is configured to dispense the drug in response to changes in blood pressure values and/or in projected blood pressure values. Drug delivery device120may be configured to dispense the drug in response to parameters or characteristics of the blood pressure profile including pulse shape, and/or systolic/diastolic blood pressure values. Drug-delivery device120may include one or one or more needles and/or, microjets for delivery of the drug to the individual. Alternately or additionally, drug-delivery device120may be configured to use iontophoresis and/or sonophoresis for delivery of the drug to the individual.

Drug delivery device120may include or supplied by a drug reservoir150. Drug reservoir may be disposed ex-vivo or in-vivo (e.g., sub-dermal or buccal). The drug may be delivered, for example, into the gastrointestinal tract or the vasculature of the individual to suppress the hypertensive excursions and toward maintaining blood pressure(s) in physician-specified ranges. The dispensed drug may be any suitable drug or combination of drugs that are prescribed for treatment of blood pressure conditions. Common drugs prescribed treatment of blood pressure conditions include, for example, diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta blockers, calcium channel blockers (CCBs), blood vessel dilators, alpha blockers and nervous system inhibitors. Medical quantities of interest for several pertinent medications may be in the range of a few mg to a few dozen mg daily. Thus a modest capacity of reservoir150may readily suffice for multi-month intervals between refilling. Drug delivery device120may be configured to dispense the drug to dynamically regulate the individual's blood pressure. The dispensed drug may be intended to lower or raise the individual's blood pressure, and/or to reach or maintain a target blood pressure or range. Alternatively or additionally, the dispensed drug may be intended to treat a condition sensitive to a result and/or effect of the individual's blood pressure.

A further version of device120may include an altitude-sensing device (e.g., an accelerometer) configured to determine an altitude of blood pressure sensor110. Device100may use processing circuitry130or other circuits to correct a blood pressure measurement for a relative height or altitude of blood pressure sensor110. For example, device100may be configured to distinguish blood pressures measurements made when the individual is sitting form those made when the individual is standing.

FIG. 2. shows an exemplary system200utilizing a skin patch210to deliver drugs for real or near real-time treatment of hypertension or other blood pressure excursions in an individual. Skin patch210has a blood pressure sensor220structurally integrated therein. The integrated structure210/220is configured to be attached to a skin portion of an individual. Blood pressure sensor220is configured to determine a blood pressure of the individual and skin patch210is configured to needle-lessly deliver a drug dermally or transdermally to the individual in response to the determined blood pressure.

Blood pressure sensor220, which is integrated with skin patch210, may be any suitable type of device for measuring blood pressure. For example, blood pressure sensor220may be a mechanical, optical, and/or electric sensor. Blood pressure sensor220, like sensor110, may be an ultrasonic sensor (e.g., a broad angle, a directed, a bistatic sensor, or a phased array ultrasound sensor). Blood pressure sensor220may be battery powered.

Blood pressure sensor220may be configured to locate a blood vessel in the vicinity of the applied skin patch and make one or measurements of blood pressure in the located blood vessel. Blood pressure sensor220may be further configured to measure a blood pressure response to applied energy he blood pressure sensor may be configured to apply sufficient energy to jostle blood in a blood vessel or the blood vessel itself. Blood pressure sensor220may be configured to measure dynamic changes in a blood vessel size or elasticity that are indicative of the blood pressure. Blood pressure sensor220may be configured to make Doppler measurements of a blood flow in the individual by correlating blood velocity and pressure. Skin patch210may include a microprocessor216for processing blood pressure data and drug-delivery instructions.

Skin patch210may include electrical circuits to deliver the drug to the individual using iontophoresis and/or electroporation. Alternatively or additionally, skin patch210may include suitable electronic or mechanical drivers to deliver the drug using iontophoresis, sonophoresis, microjets, and/or needle-less injection. The electrical circuits/drivers may be configured to deliver the drug in response to current, average and/or cumulative blood pressure values, in response to trends in blood pressure values and/or to projected blood pressure values, and/or in response to parameters or characteristics of the blood pressure profile including pulse shape, and/or systolic/diastolic blood pressure values.

A version of skin patch210may include an input/output communications interface250for communicating blood pressure values, system actions and/or system status with an external point via the input/output communications interface.

A further version of system200may include an altitude-sensing device212(e.g., an accelerometer configured to determine an altitude of blood pressure sensor220. Skin patch210may include suitable processing circuitry to correct a blood pressure measurement for a relative height or altitude of blood pressure sensor220. For example, system200may be configured to distinguish blood pressures measurements made when the individual' arm is lowered (e.g., while sitting) from those made when the arm is raised or higher while standing.

System200may be configured so that skin patch210delivers the drug to dynamically regulate the individual's blood pressure. The type and amount of drug dispensed may be to lower or raise the individual's blood pressure, or reach or maintain a target blood pressure or range. Skin patch210may additionally or alternatively deliver a drug to treat a condition sensitive to a result and/or effect of the individual's blood pressure.

FIG. 3shows another exemplary blood pressure measurement and treatment system300, system300includes an inflatable cuff310, a pressure-measuring device320and a drug-delivery device330that is integrated or built into inflatable cuff310.

Inflatable cuff310generally has the same or similar construction as inflatable cuffs that are commonly used in conventional home, clinic or doctor's office blood pressure measurement systems. See e.g. Thede, Roger C. U.S. Pat. No. 6,932,773 Wrist type blood pressure meter cuff; Itonaga, Kazunobu et al. U.S. Pat. No. 6,336,901 Sphygmomanometer cuff achieving precise measurement of blood pressure; Sionell Goran U.S. Pat. No. 4,572,205 Method at blood pressure measurement and a blood pressure cuff for carrying out the method; Nishibayashi, Hideo U.S. Pat. No. 6,969,356 Inflatable cuff for blood pressure measurement; Knoblich, Stanley M. U.S. Pat. No. 5,069,219 Self snugging universal blood pressure cuff; Williams U.S. Pat. No. 4,117,835 Method and apparatus for blood pressure measurements; Gorelick, Donald E. U.S. Pat. No. 4,116,230 Blood pressure cuff automatic deflation device; Speidel, Blasius U.S. Pat. No. 4,116,217 Deflation valve for blood pressure measuring devices; Affeldt, et al. U.S. Pat. No. 4,112,929 Method for measuring the blood pressure of a patient; Keller U.S. Pat. No. 4,109,646 Automatic blood pressure cuff applicator; Aldridge, et al. U.S. Pat. No. 4,108,310 Blood pressure testing kit; Ueda U.S. Pat. No. 4,106,499 Sphygmomanometer cuff; and Williams et al. U.S. Pat. No. 4,105,021 Method and arrangement for measuring blood pressure. All of the foregoing patents and other references cited in this disclosure are incorporated by reference in their entireties herein.

In system300, inflatable cuff310like conventional blood pressure measurement cuffs includes a flexible tape, band or strip312that can be wrapped and secured around an individual's limb (e.g. arm, leg or finger). An inflatable bag or bladder314made of the same or other materials is built into tape, band or strip312. When blood pressure is measured, cuff310is inflated, automatically or manually, to constrict an artery so that no blood flows through. Since the pressure in the cuff is greater than the pressure in the artery, the artery is closed off and no blood flows through. As the cuff pressure is gradually released, but the artery is still partially constricted, blood flow resumes. In the auscultatory method of measuring blood pressure that has been traditionally deployed in doctors' offices and clinics, the sounds can be heard with a stethoscope because the blood flows turbulently, causing audible sounds. When enough cuff pressure is released to fully open the artery, the blood flows freely and the sounds disappear because smooth flowing blood does not create sounds. (SeeFIG. 4). As the cuff is deflated and blood flow resumes through the partially constricted artery, the first sounds correspond to systolic pressure and the end of sounds correspond to diastolic pressure.

Automated or electronic oscillometric blood pressure monitors do not rely on sound detection but instead depend on analysis of pressure pulses or waves. They measure mean arterial pressure (MAP) and use oscillometric detection to calculate systolic and diastolic values. When the cuff starts to deflate, blood resumes flowing, causing the artery walls to vibrate. The cuff senses these vibrations and a blood pressure meter recognizes this as the systolic pressure. When the blood resumes normal flow, vibrations cease. The blood pressure meter recognizes this as the diastolic pressure. Other methods, for example, include ultrasound (used mainly to detect systolic pressure) and the finger cuff method of Penaz, which can record beat-to-beat arterial pressure noninvasively from the finger. See e.g., Booth, J (1977). “A short history of blood pressure measurement”. Proceedings of the Royal Society of Medicine 70 (11): 793-9.

In system300, inflatable cuff310is coupled to a suitable electronic blood pressure measuring device320for measuring or deriving blood pressures from physical changes (i.e., arterial constriction and deconstriction) resulting from the inflation/deflation of cuff310. Device320may utilize any suitable non invasive technique to measure or derive blood pressure values. The suitable technique may, for example, be based on mechanical, audio, ultrasound, or optical detection of cuff pressure responses and behaviors. Correspondingly, device320may include suitable mechanical, audio, ultrasound, optical, and/or electric sensors and processors. The technique utilized may involve actual pressure measurements or microprocessor analysis of pressure oscillations or waves. Further, the measured or derived blood pressure values may correspond to the systolic pressure or diastolic pressure, mean arterial pressure or any other indicia of blood pressure behavior of the individual. For convenience in description, all of these measured or derived blood pressure values may be referred to herein as “the measured pressure(s) corresponding to the individual's diastolic and/or systolic blood pressures.”

With renewed reference toFIG. 3, system300further includes drug-delivery device330integrated with inflatable cuff310and coupled to electronic blood pressure measuring device320. Drug-delivery device330is configured to automatically deliver a drug (e.g. dermally or transdermally) to the individual in response to the measured blood pressure(s).

System300may be suitably adapted to be used by an ambulatory individual to monitor and treat blood pressure excursions in real or near real time. Inflatable cuff310worn by the individual may be configured for manual or automatic inflation/deflation. An automatically inflating cuff310may be configured to automatically inflate and deflate more than once according to a predetermined schedule (e.g., once every one or two hours).

Drug-delivery device330may include or have access to a drug reservoir, depot, or store of suitable medication for treating blood pressure excursions or conditions of the individual.

In general drug delivery device330may utilize any know technique for drug delivery. Drug-delivery device330may, for example, include suitable electrical or electronic circuits to deliver the drug using iontophoresis, sonophoresis and/or electroporation. Other versions of drug-delivery device330may, for example, include suitable mechanisms to deliver the drug using abrasion, ablation, microneedles and/or perforation. Yet other versions of drug-delivery device330may, for example, include pneumatic or mechanical drivers to deliver the drug into the individual using microjets, and/or needle-less injection.

System300may include a suitable controller332(e.g., a microprocessor based controller) configured to process blood pressure data and other data. Controller332may be configured to activate drug delivery device330to deliver prescribed amounts of the medication to treat the measured blood pressure excursions or conditions of the individual. Controller332may be configured to activate drug delivery device330to deliver the drug to the individual in response to one or more of, for example, current, average and/or cumulative blood pressure values, changes in blood pressure values and/or in projected blood pressure values. In a version of system300, controller332may be configured to activate drug delivery device330to deliver the drug to the individual in response to parameters or characteristics of the blood pressure profile including pulse shape, and/or systolic/diastolic blood pressure values.

System300may further include a memory unit334to store blood pressure data and drug-delivery instructions. System300may also include an input/output communications interface336. Controller332may, for example, communicate blood pressure values, system actions, and/or system status to, or receive drug delivery instructions from, an external source over wired or wireless links via input/output communications interface336. Controller332and other electrical or electronic components of system300may be battery powered.

A version of system300may include an altitude-sensing device (e.g., an accelerometer) configured to determine an altitude of inflatable cuff310as worn by an individual during a blood pressure measurement. Controller332or other suitable processing circuitry included in system300may be configured to correct the blood pressure measurement for a relative height or altitude of inflatable cuff310. For example, controller332may be configured to distinguish blood pressures measurements made when the individual' arm is lowered when sitting from those made when the arm is raised.

System300may be configured to deliver the prescribed drug to dynamically regulate the individual's blood pressure. System300may be configured to deliver the prescribed drug to lower or raise the individual's blood pressure(s), or to reach or maintain a target blood pressure or range. System300may also be configured to deliver to deliver a drug to treat a condition sensitive to a result and/or effect of the of the individual's blood pressure.

FIGS. 5-7show exemplary methods500-700for promptly treating blood pressure incidents in an individual on real time or near real time.

Method500(FIG. 5) includes providing a blood pressure monitoring unit having a built-in ultrasound sensor and a drug delivery device (510) that can be attached to an individual. The blood pressure monitoring unit may be adapted to be attached to a skin portion of the individual and/or to be fully or partially implanted in the individual. The ultrasound sensor may be configured to locate a blood vessel in operation and make one or measurements of blood pressure in the located blood vessel.

Method500further includes making one or more blood pressure measurements of the individual with the ultrasound sensor in the attached unit (520), and using the attached drug-delivery device to dispense a drug to the individual in real time or near real time response to the measured blood pressure measurements as prescribed or appropriate to treat the individual's condition (530).

In method500, providing a blood pressure monitoring unit having a built-in ultrasound sensor and a drug delivery device (510) may include providing a unit having a processing circuit configured to process blood pressure data and other data. Further, providing a blood pressure monitoring unit having a built-in ultrasound sensor and a drug delivery device (510) may include providing a drug-delivery device configured to dispense the drug to dynamically regulate the individual's blood pressure, to lower or raise the individual's blood pressure, reach or maintain a target blood pressure or range and/or to treat a condition sensitive to a result and/or effect of the individual's blood pressure.

Further in method500, providing a blood pressure monitoring unit having a built-in ultrasound sensor and a drug delivery device (510) may include providing one of a broad angle sensor, a directed beam sensor, a bistatic sensor and a phased array ultrasound sensor. The sensor may be configured to make Doppler measurements of a blood flow in the individual by correlating blood velocity and pressure.

In a version of method500, providing a blood pressure monitoring unit having a built-in ultrasound sensor and a drug delivery device (510) may include providing a sensor configured to measure dynamic changes in a blood vessel size or elasticity that are indicative of the blood pressure. In another or same version of method500, providing a blood pressure monitoring unit having a built-in ultrasound sensor and a drug delivery device (510) may include providing a unit configured to apply sufficient energy to jostle blood in a blood vessel or the blood vessel itself and a sensor configured to measure the blood pressure response to the applied energy.

In a version of method500, providing a blood pressure monitoring unit having a built-in ultrasound sensor and a drug delivery device (510) may include providing a drug-delivery device having one or one or more needles and/or, microjets for delivery of the drug to the individual and/or uses iontophoresis and/or, sonophoresis for delivery of the drug to the individual.

In method500, using the attached drug-delivery device to dispense a drug to the individual in response to the measured blood pressure measurements as prescribed or appropriate to treat the individual's condition (530) may include, for example, dispensing the drug in response to current, average and/or cumulative blood pressure values, changes in blood pressure values and/or in projected blood pressure values, and/or in response to parameters or characteristics of the blood pressure profile including pulse shape, and/or systolic/diastolic blood pressure values.

Method500may further include providing the blood pressure monitoring unit with an input/output communications interface, a memory unit and/or a microprocessor. The memory unit may be configured to store one or more measured blood pressure values and/or drug-dispensation instructions. The microprocessor may be programmed to execute drug dispensing instructions, for example, based on blood pressure values. The input/output communications interface may be a signal or data interface configured to receive parameters relating drug dispensation requirements and blood pressure values, and/or other instructions from an external source. Method500may further include communicating blood pressure values, device actions and/or device status with an external point or source via the input/output communications interface.

A version of method500may further include providing an altitude sensing device (e.g., an accelerometer) configured to determine an altitude of the ultrasound sensor, and a circuit.

Method600(FIG. 6) includes providing a drug-delivery skin patch having a structurally integrated or built-in blood pressure sensor (610). The drug-delivery skin patch is adapted to be attached to a skin portion of an individual to needle-lessly deliver a drug dermally or transdermally to the individual. The built-in blood pressure sensor is configured to locate a blood vessel in operation and make one or measurements of blood pressure in the located blood vessel.

Method600further includes configuring the skin patch to needle-lessly deliver a drug dermally or transdermally to the individual as may be prescribed or appropriate in response to blood pressure determinations with the built-in blood pressure sensor (620).

In method600includes providing a drug-delivery skin patch having a structurally integrated or built-in blood pressure sensor (610) may include providing a mechanical, optical, ultrasonic, and/or electric blood pressure sensor. The ultrasonic sensor may be one of a broad angle, a directed, a bistatic and/or a phased array ultrasonic sensor. The ultrasonic sensor may be configured to make Doppler measurements of a blood flow in the individual by correlating blood velocity and pressure.

Further, in method600providing a drug-delivery skin patch having a structurally integrated or built-in blood pressure sensor (610) may include providing a blood pressure sensor that is configured to measure dynamic changes in a blood vessel size or elasticity that are indicative of the blood pressure. The blood pressure sensor may be configured to apply sufficient energy to jostle blood in a blood vessel or the blood vessel itself and to measure a blood pressure response to applied energy.

In method600configuring the skin patch to needle-lessly deliver a drug dermally or transdermally to the individual as may be prescribed or appropriate in response to blood pressure determinations with the built-in blood pressure sensor (620) may providing electrical circuits and/or pneumatic or mechanical drivers to deliver the drug using iontophoresis, electroporation, sonophoresis, via microjets, and/or needle-less injection.

Further, in method600configuring the skin patch may include configuring the skin patch to deliver the drug in response to current, average and/or cumulative blood pressure values, in response to trends in blood pressure values and/or to projected blood pressure values, and/or in response to parameters or characteristics of the blood pressure profile including pulse shape, and/or systolic/diastolic blood pressure values.

Method600may further include providing a processing circuit (e.g., a microprocessor) and an input/output communications interface in the skin patch. The processing circuit may be configured to process blood pressure data and other data. The processing circuit may be further configured and to communicate blood pressure values, system actions and/or system status with an external source or point via the input/output communications interface.

Method600may also include providing an altitude sensing device (e.g. an accelerometer) configured to determine an altitude of the blood pressure sensor, and configuring the processing circuit or other circuits to correct a blood pressure measurement for a relative height of the sensor.

Method600may further include configuring the skin patch to deliver the drug to dynamically regulate the individual's blood pressure, to lower or raise the individual's blood pressure, to reach or maintain a target blood pressure or range and/or to treat a condition sensitive to a result and/or effect of the individual's blood pressure.

Method700(FIG. 7) includes providing a blood pressure measurement system that can be attached to an individual (710). Providing a blood pressure measurement system that can be attached to an individual (710) includes providing an inflatable cuff configured to restrict a blood flow in the individual (712), and providing a pressure measuring device coupled to the inflatable cuff which device is configured measure pressure(s) corresponding to the individual's blood pressures (714). Providing a blood pressure measurement system that can be attached to an individual (710) further includes providing a drug delivery device integrated with the inflatable cuff and configuring the drug delivery device to automatically deliver a drug dermally or transdermally to the individual in response to the measured blood pressure(s) as prescribed or necessary (716).

In method700, the inflatable cuff may be configured for may be for manual or automatic inflation. The inflatable cuff may, for example, be configured to automatically inflate and deflate more than once according to a predetermined schedule. Further, the pressure measuring device may include a mechanical, audio, optical, and/or electric sensor.

Further in method700, providing a drug delivery device integrated with the inflatable cuff may include providing the drug delivery device with electrical circuits and other pneumatic or mechanical mechanisms or drivers to deliver the drug using one or more of iontophoresis, sonophoresis and/or electroporation, abrasion, ablation, microneedles, perforation, microjets, and/or needle-less injection.

Method700may further include configuring the drug delivery device to deliver the drug in response to current, average and/or cumulative blood pressure values, changes in blood pressure values and/or in projected blood pressure values, and/or in response to parameters or characteristics of the blood pressure profile including pulse shape, and/or systolic/diastolic blood pressure values.

Like method600, method700may also include a processing circuit configured to process blood pressure data and other data. Method700may also further include providing an input/output communications interface and configuring the blood pressure measurement system to communicate blood pressure values, system actions, and/or system status with an external point via the input/output communications interface.

Method700may also include providing an altitude sensing device (e.g. an accelerometer) configured to determine an altitude of the pressure measuring device, and configuring the processing circuit or other circuits to correct a blood pressure measurement for a relative height of the sensor.

Method600may further include configuring the drug delivery device to deliver the drug to dynamically regulate the individual's blood pressure, to lower or raise the individual's blood pressure, to reach or maintain a target blood pressure or range and/or to treat a condition sensitive to a result and/or effect of the individual's blood pressure.

Those skilled in the art will recognize that at least a portion of the devices and/or processes described herein can be integrated into an image processing system. Those having skill in the art will recognize that a typical image processing system generally includes one or more of a system unit housing, a video display device, memory such as volatile or non-volatile memory, processors such as microprocessors or digital signal processors, computational entities such as operating systems, drivers, applications programs, one or more interaction devices (e.g., a touch pad, a touch screen, an antenna, etc.), control systems including feedback loops and control motors (e.g., feedback for sensing lens position and/or velocity; control motors for moving/distorting lenses to give desired focuses). An image processing system may be implemented utilizing suitable commercially available components, such as those typically found in digital still systems and/or digital motion systems.

Those skilled in the art will recognize that at least a portion of the devices and/or processes described herein can be integrated into a mote system. Those having skill in the art will recognize that a typical mote system generally includes one or more memories such as volatile or non-volatile memories, processors such as microprocessors or digital signal processors, computational entities such as operating systems, user interfaces, drivers, sensors, actuators, applications programs, one or more interaction devices (e.g., an antenna USB ports, acoustic ports, etc.), control systems including feedback loops and control motors (e.g., feedback for sensing or estimating position and/or velocity; control motors for moving and/or adjusting components and/or quantities). A mote system may be implemented utilizing suitable components, such as those found in mote computing/communication systems. Specific examples of such components entail such as Intel Corporation's and/or Crossbow Corporation's mote components and supporting hardware, software, and/or firmware.

Those skilled in the art will recognize that it is common within the art to implement devices and/or processes and/or systems, and thereafter use engineering and/or other practices to integrate such implemented devices and/or processes and/or systems into more comprehensive devices and/or processes and/or systems. That is, at least a portion of the devices and/or processes and/or systems described herein can be integrated into other devices and/or processes and/or systems via a reasonable amount of experimentation. Those having skill in the art will recognize that examples of such other devices and/or processes and/or systems might include—as appropriate to context and application—all or part of devices and/or processes and/or systems of (a) an air conveyance (e.g., an airplane, rocket, helicopter, etc.), (b) a ground conveyance (e.g., a car, truck, locomotive, tank, armored personnel carrier, etc.), (c) a building (e.g., a home, warehouse, office, etc.), (d) an appliance (e.g., a refrigerator, a washing machine, a dryer, etc.), (e) a communications system (e.g., a networked system, a telephone system, a Voice over IP system, etc.), (f) a business entity (e.g., an Internet Service Provider (ISP) entity such as Comcast Cable, Qwest, Southwestern Bell, etc.), or (g) a wired/wireless services entity (e.g., Sprint, Cingular, Nextel, etc.), etc.

In certain cases, use of a system or method may occur in a territory even if components are located outside the territory. For example, in a distributed computing context, use of a distributed computing system may occur in a territory even though parts of the system may be located outside of the territory (e.g., relay, server, processor, signal-bearing medium, transmitting computer, receiving computer, etc. located outside the territory).

A sale of a system or method may likewise occur in a territory even if components of the system or method are located and/or used outside the territory.

Further, implementation of at least part of a system for performing a method in one territory does not preclude use of the system in another territory.

Although user is shown/described herein as a single illustrated figure, those skilled in the art will appreciate that user may be representative of a human user, a robotic user (e.g., computational entity), and/or substantially any combination thereof (e.g., a user may be assisted by one or more robotic agents) unless context dictates otherwise. Those skilled in the art will appreciate that, in general, the same may be said of “sender” and/or other entity-oriented terms as such terms are used herein unless context dictates otherwise.