CA1038044A - Implantable diagnoser and medication dispenser - Google Patents

Implantable diagnoser and medication dispenser

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Publication number
CA1038044A
CA1038044A CA225,432A CA225432A CA1038044A CA 1038044 A CA1038044 A CA 1038044A CA 225432 A CA225432 A CA 225432A CA 1038044 A CA1038044 A CA 1038044A
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Canada
Prior art keywords
medication
dispensing
housing
storage member
plural
Prior art date
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Expired
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CA225,432A
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French (fr)
Inventor
Everett H. Ellinwood (Jr.)
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Individual
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Individual
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14276Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021Measuring pressure in heart or blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316Modalities, i.e. specific diagnostic methods
    • A61B5/318Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346Analysis of electrocardiograms
    • A61B5/349Detecting specific parameters of the electrocardiograph cycle
    • A61B5/364Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A61M5/1723Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/365Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36514Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3507Communication with implanted devices, e.g. external control
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00Surgery
    • Y10S128/01Motorized syringe
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00Surgery
    • Y10S128/13Infusion monitoring

Abstract

ABSTRACT OF THE DISCLOSURE
An apparatus for dispensing drugs and other medications within the body is adapted to be entirely implanted and to dis-pense such substances over a long period of time, e.g., one to several years, in accordance with the actual needs of the patient.
A self-powered dispensing device stores a single or plural sub-stances in powdered liquid, or other dispensable form. Logic and self-timing means control dispensing by monitoring single or plural sensors implanted in the body and evaluating the sensed data in order to control both the conditions under which and the kind of dispensing which takes place.

Description

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BACKGROUND OF THE INVENTION
1. Field of the Invention -This invention pertains to dispensing medical or physio-logical substances or matter internally and more specifically to implanted apparatus for dispensing these substances over a long period of time accoxding to the specific needs of the patient at the times the substances are dispensed.
2. Description of the Prior Art A review of prior art practices with regard to dispensing medical substances internally of the body is given in the appli-cant's U.S. Patent No. 3,692,027 issued Septembex 19, 1972 to which reference is made. So far a~ I am aware, my prior P~tent No.
3,692,027 provides the first teaching o~ a sel~-powered de~ice which can be implanted and which i5 adapted to dispense medical substances in premeasured doses at specific intervals over a long period of time. There has appear~d in the June 1973 issue of For-tune magazine an article describing other continuous diffusion capsule types of dispensing devices. This article points out and emphasizes the tremendous need for long term medication dispensing devices which can provide for dispensing of medication at specific target organs or target sites. ~he prior art in the area of diffusion devices is also illustrated in U.S. Patent No. 3,279,996 by David M. Long and Moses Judah Folkman issued October 18, 1966 for a polysiloxane carrier for controlled release of drugs and other agents. The device of this patent con~ist~ af a silicone rubber container with the drug being soluble and capable of diffusing through the silicone rubber to the outer surface of the container. A further development of this device was reported in the literature in the Annals of the New York Academy of Sciences, vol. 111, 1963-64 on pages 857-868 by Judah Folkman and David Long in which an electrical ~ . " ~"

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1 volta~e is described as being applied to the container and to an outside electrode, in an attempt to increase the diffusion of materials through the fibrous scar tissue which is caused to be thrown up around the container by reason of its being implanted into the myocardium. The medication is described as being pulled throuyh the myocardial fibrous scar tissue by means of iontophoresis. In these adaptations, the medication is in a eontinuous diffusion state and is not pre.sented in discrete doses at timed intervals or according to the physiological needs.

Related to the present invention is the practice of implanting devices whieh sense heart conditions by meAn~ o~ ~he eardiae eleetrical activi~y and trigger el~ctriaal pulses ~o effeet the h~art rate according to the sensed data. These deviees have generally been cateyorized as "pacemakers" and their use proves that the human body can accept implanted devices without endangering human life in the implantation procedure.
They have also provided documentation for the applicability of feedback in the instance of the demand pacemaker version in ~ which the output is controlled by the pacemaker logic which makes decisions on the basis of the electrical activity of the heart. The feasibility of the demand pacemaker for implantation is documented in the article listed below.
1) Goetz, R.H.; Goldstein, J.V.; Fraterr R.W.M., Berkovitsr B. ~ "Demand Pacemaking in Intermit-tant Heart-Block", ~ouxnal of the American Medical Assoeiationr Vol. lOr pp. 657-662, 1968.
2) Nathan, D.A.; Centerr S.; Wur C.; Kellerr W.; "An c ~
f~ Imp]antable, Synchronou~ ~d~e~a for the Long Term Correction of Complete He~rt-Block", Circulation, Vol.

XXVII, pp. 682-685, 1963.

3~
3) Fischler, H.; Barr, I.M. ~ uerback, Yerushalmi S.;
S~ ieoi w ~ Neufeld, H.N. - "Atrial-Sieb4l~L~ Demand Heart Pacing".
IEEE Transactions on Biomedlcal Engineering, Vol. BME~16, pp. 6~-69.
A further area of the prior art related to the inven-tion concerns the various types of sensors some of which are now commercially available and which can be used to accurately sense physiological and chemical body conditions. At present, the output of most of these devices that sense body changes are recorded and/or acted on by devices external to the body. For example, glucose detection, pN detection, ionic change detection, blood pressure ox blood 10w detection, electrical ac~ivik~
detection, respiratory detection, and gastroint~lnal motility detection all constitu~e ex~s~lng prac~ical types of sensing apparatus.
It should also he recogni~ed that the prior art has shown that an implanted device having a battery supply can be electric~ ly rech~rge~ wi~hou,t having to remove the device.
~ ~e ,7~ e ~a~e~f Also, my~ow~ ra-tcn* 3,692,027 refers to means for recharging an implanted medication supply. Thus, both implanted battery and medication storage recharging are known.
From the foregoing, it can be seen that while the implanting technique has been perfected in many respects, and that while both the diffusion device which releases medication continuously and my own self-powered technique which provides a means for dispensing medical substances in pre-measured doses on a continuous basis or at predetermined regular intervals, no dispensing device or method has appeared in the prior art which allows medical substances to be dispensed by an implanted device and according to specific physical requir~ments of the patient that are determined by the device itself.

SUMMARY OF THE INVENTION

The apparatus and method of the invention is based on the apparatus being entirely implanted in the body. There is provided either one or a plurality of sensors, each of which is adapted to sense a particular body condition at a particular point in the body. There is also provided a self-powered medi-cation dispensing apparatus whose operation is made dependent on evaluation of changes in the sensed data. The dispensing apparatus and method of the invention can be directed to one or a plurality of medical substances in powdered, liquid, suspen-sion, or other dispensable form. The d~cision making capability of the invention which functions on a basis of chang~s .in the sensed data, controls when the dispensing appara~us operates and therefore controls the dispensing of medication according to the specific needs of the patient at specific times.

DESCRIPTION OF THE DRAWINGS

Figure 1 is a block diagra~ illustrating the basic components of an apparatus according to the invention;
Figure 2 is a block diagram illustrating the appli-cation of the invention to cardiac monitoring and medication;
Figure 3 is a block diagram illustrating the appli-cation of the invention to blood pressure monitoring and medi-cation;
Figure 4 is a block diagram illustrating applicat.ion of the .invention to blood chemistry monitoring and medication;
Figure 5 is a block diagram illustrating application of the invention to dlspensing medicat.ion to the same site from multiple sources.

~L~3~
Figure 6 is a block diagram illustrating application of the invention to dispensing different medications to diferent sites;
Figure 7 is a somewhat schematic and enlarged diagram of a minature bellows pumping device useful in the invention;
Figure 8 is a somewhat schematic enlarged view of a multiple bellows type pump for dispensing the same medication to the same s.ite but in different quantities and under different conditions;
Figure 9 is a somewhat schematic enlarged diagram of a multiple bellows type pump for dispensing separate kinds of medication to separate sites in different quantities and under separate controls;
Figure 10 i9 a somewhat schema~ic enlarged clrawin~ oE
a bellows pump with multiple separa~ed chambers ~or di~erent chambers or sites having a common power source;
Fiyure 11 is a somewhat schematic enlarged view of an implantable system according to the invention and adapted to dispense different medications from dif~erent sources under different controls;
Figure 12 i.s a schematic diagram of the apparatus of the invention as it might be used with superventricular tachy-cardias treated with quinidine;
Figure 13 is a schematic sectional view through the apparatus of Figure 12;
Figures 14 and 14A schematically illustrate a portal arrangement for replenishing medication to the system;
Figure 15 is a block diagram of the decision making circuitry;

Figure 16 is a more detailed circuit diagram corres-pDnding to Figure lSi and ~3~
1 Figure 17 (located on page with Figure 14) i5 a repre-sen ative timing diagram for dispensing plural doses of medication.
BACKGROUND FOR LATER DESCRIPTION

Prior to describing the apparatus and method which constitutes the invention, background information will be given concerning specific and recognized medical problems to which the invention method and apparatus may be applied. With this background, the mechanisms and methods later described will be better understood.
The general concepts behind the applications to be explained revolve around sensing and evaluation o~ biological signals that relate to abnormal processes or variations in normal processes in the body that may be used to evaluat~ the need ~or release oE the yiven medication, hormone, or other type of chemical into the body or into speciic organ or target s.ites.
The dispensation of mediaatlon into specific organ sites, by the means of a small catheter~ may of course allow for small quantities to be much more potent at the targe-t site without systemic side effects developing. In additionr the concept of feedback evaluation controlling or altered release of medica-tion will allow for an intermittent dispensin~ of the drug which might handle a problem at much lower doses than iE medication is given over a sustained period without sensitiv~ regard for therapeutic needs and the possible development o:E various toxic and tolerant eifects. For example, an appllcation tha~ w:L11 b~
described later is that of transducing a pressure chanye in the blood vessels to provide information to the decision mak:ing capacity of logic and timing circuits in the device which aati~ate a self-powered pump, to release a given quantity of a blood 1 pressure reducing medication. The decision to dispense the medication is intended to operate only when the pressure rises above a certain level. This type of operatlon offers the opportunity to help overcome some of the undesirable effects from drugs such as adrenergic blocking agents, ~hich when given chronically produce untoward side effects, including psycholo-gical depression and orthostatic hypotension. The same is true with a variet~ of other blood pressure reducing drugs. In other applications to be described later, physiological signals that predict the toxic effect of a given drug can be used by the device in evaluating the needed medication dispensation.
Thus, the toxic effects can be counterpointed against the therapeutic need or medication by the logia ~yst~3m of th~
invention.
Involved in the biolo~lcal sensing for blood pressure or other physiological changes that the device is evaluatirlg, are possible training of physiological responses, effects or behavioural modification effects, by means of appropriate programming of such a device with small logic circuits. The type of signal detected and usea for processing in the logic circuits may be either one signal. or a combination of bio-signals, one or several being necessary ~or the triggering of the later described pump dispensing device. For example, by implanting an appropriate device in drug addicts one may monitor a variety of physiological changes produced by the injection of a narcotic; that is, respiratory depression measured hy a micro strain gauge attached to the diaphram, a strain gauge attached to the stomach or in the upper duodenum to measure gastro-intestinal mo~i.lity and the type of motili.ty, and a pressure transducer to measure the increase in biliary duct pressure, and use the combi.nation of these signals to detect the injection ~33~
1 of a narcotic; the dispensing pump may then release a narcotic antagonist and/or, for behavioural training, may release a drug that would cause nausea and vomiting, thus providing for behavioural modification or avoidance conditioning.
The types of application uses with evaluation of bio-logical signals according to the invention include: 1) chemical transducers and feedback such as glucose detection, pH detection, ionic change detection; 2) temperature, pressure, or mechanical transduced changes; for example, blood pressure, blood flow gut motility; and 3) electrical activity as might be measured in the electrocardiogram or electroencephalogram. In the electro-encephalogram and electrocardiogram, speoial logic circuits may be de~ised according to the i.nvention on a miniature basis to provide ~or analysis o~ abnormal signals or rhythms and then the dispensation of a given amount of drug into the specific target organ. For example, with certain cardiac arythmias, the invention recognizes that it is possible to detect and evaluate these abnormalities with fairly simple logic circuits and then to dispense a drug into the pericardial sac in a similar manner that demand pacemakers now operate.
One of the ~disease types closely related to the inven-tion is malignant hypertension. Malignant hypertension in the untreated state has a two-year mortality of 90% and a five-year mortality of almost 100~. Sympathectomy is capable of reducing the two-year mortality to 50~ and the five-year mortality to 80~. The newer anti-hypertension drugs have been more effective than this. What this invention provides is a method for treat-ing malignant hypertension that is based on sensors inside the body and medication pumped to various ef~ector si.tes. The sensors may include 1) blood pressure detecting devices in the ~38~L4 neck and/or in the lower extremities; 2~ electrical activity from the carotid sinus or aortic body; 3) possible electrical activity from the sympathetic outflow; and 4) the electrocardio-gram. Blood measurements allow the mechani~ o~ t~e invention 2 ~ to differentiate, for example, between the d~Ystolic and systolic ratios. Combination of information from the sensors may be programmed in micro-miniature logic circuits to provide a series of treatment decisions based on the individual characteristics of the patient.

On the effec-tor side, the physician is given a wide choice with the present invention of attacking the problem of malignant hypertension in several sites: l) the sympathetic outflow can be blocked with ganglionic blockers; 2) tho aclronal outflow or releasing mechanisms can be blocked with ganc~lionlc blockers; 3) appropriate drugs are available which can be dis-pensed systematically to block the adrenergic receptors through-out the body; and 4) another group of drugs known as the vara-trum viride compounds are available and which may be dispensed according to the invention to inhibit the pressure centers in the brain itself. Taking only two of the mentioned examples, it is now possible to devise effector sites in 1) the sympathetic chain or outflow and 2) systemic sites via intraperitoneal dis-pensation. Using four sensors and two effector sites it is now possible to set up an array of contingencies, only some of which ~,'c~s~c will be described. For example, iE the ~ e~e blood pressure i.ncreased beyond a certain point, the systemic circulation, actually a site in the interperitoneal cavity, may receive a dose of beta adrenergic blocker antihypertensive medicat.ion;

in addition, by means of carefully monitored rel~ase of drugs to the sympathetic outflow via a catheter, it is now possible to increase the effectiveness of the antihypertensive dru~s by _ g _ ~31~Q~
1 blocking this outflow. As discussed previously, this local application could help to prevent many of the serious side ef ~ cts of systemic ganglionic blocking medication. Problems ~ C~ ~e~
in ~ h~ may be monitored with neck blood pressure devices "~ ,~., or with the electrical activity from the carotid sinus. Various features in the contingencies may be based on the normal exercise patterns of the individualr for example, in persons who have a heavy exercise load, the logic mechanism of the invention may be established to re~pon~ ~only after two to three G~7~ a or even four hours of increased dys-toli~ pressure thus allowing ~or extended periods of exercise with sliyhtly increased pressure.
Comhinations o the devices shown in the drawings may be used to supply drugs at the various effector site~.

In one sp~cific adap~at,ion a ~lood pre~sure sen~or ~ s~o/, c~
picks up both the systolic and d~o~e blood pressure levels which are then amplified, or at least the analog signal is amplified, and presented to a detector and logic timer system , .
using microminiature logic systems in which several decisions are made:
23 1. Is blood pressure above criteria level less than 30% of the heartbeats over a given period of time? If the answer to this is negative, then there is no release from the later described pump system. The reader should keep in mind that the pump system might operate six times a day, or alternately, it could operate twelve times a day, thus medication decisions could be made every two or foux hours or even in fractions of hours.

2. Is the blood pressure above criteria level more than 30~

of the time? If so, the medication is rele~sed into the 3~
systemic system.

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3. Is the blood pressure above criteria moxe than 90% of the time? We woula expect that the decision would be affirmative only a rare number of occasions, but if the decision is affirmative then there is a release of another drug, a gang-lionic blocking agent directly to the sympathetic outflow in the sacral region and the first five of the thoracic lumber outflow.
The self-powered dispensing device of the invention allows for two major changes in the treatment of hypertension:

l) It allows for dispensing of the drug to a selective site inside the body, thus reducing many of the side ~ffects of more potent and hypertensive drugs. 2) It allows for a much more careful titration of the hyoptensive efects of the drugs, thus cutting down on the number of unwarranted hypotensive episodes, especially those associated with postural hypotension. One means by which this may be accomplished is by selecting the drug used for its hypotensive effects for shorter duration of action, thus allowing for blood pressure feedback to regulate dosage.

One notable example of the foregoing is in the treat-ment of severe hypertension. Currently the drug most often used in the treatment of severe hypertension is guanethidine, which is a lony-acting drug that tends to accumulate in tissues and is excreted slowly. Leaving off a dose of this medication w~uld not have a major effect for several hours, thus the potent side ef~ects could continue ~or a considerable p~r.iod of time.
Such drugs as bretylium, a short-acting hypertensive agent, have now been abandoned because of their potent side effects and poor absorption after oral administration. These effects may, how-ever, be titrated in the self-powered dispensing device of the invention. In addition, other dru~s similar to this compound, ~ 3~
for example sethanidine, (l-bensyl-2, 3-dimethylguanethidine) and other congeners may be used to a much better advantage by means of selective titration which lends itself to the apparatus and method of the invention.
The other group of drugs that increase efficacy depend on the selective ability of the device of the invention to dis-pense medication in a particular site and which group includes the ganglionic blocking agents such as hexamethonium and related compounds. Blockade of the sympathetic ganglia has a marked interrupting effect on the adrenergic control of arteriols and resul~s in vasodilation and improved peripheral blood flow o~
vascular beds and a fall in blood pressure. Par~ o~ the potency of these drugs is related to the low ratio o~ preganglionic axons to post-gangllonic axons. ~hu.s, ganglionic block has a very potent effect. rrhe major difficulty with the ganglionic blocking agents is a non-selective effect on both parasympathetic as well as sympathetic ganglions. Again, this group of drugs is poorly absorbed from the gastrointestinal tract, and there is a limited ability of these quaternary ammonium ions to penetrate cell membranes in general. By directing the outflow portal of a polyethylene catheter from the dispensing device of the invention to the sacral ganglion and to the first four ganglia of the thoracolumbar outflow the physician may selec-tively block blood vessels in large muscle of the extremities without major effects on the gastrointestinal tract, genito-urinary system, or the heart and lungs.
Cancer is another problem that may be helped with the invention's method and mechanism. For example, there may be a need to dispense different types of drugs to different body sites depending on the site vulnerability. The bi- or tri-partite 1 bellow bags, later described, may be used for this purpose. In other applications, the radio-activity of certain radio-active anti-cancer compounds may be monitored and the drug dispensed dependent on the radio-active concentrations in a given cancer site.
Another use may be in peptic ulcer or gastric ulcer.
For example, the pH may be monitored in the stomach accordiny to the invention and the antrium of the stomach may be bathed in an anti-cholinergic drug. Another use may be to bathe pain-ful spinal dorsal nerves with medication in nerve injury trig-gered externally by the patient but with the availability still controlled by the invention's timing anc1 logic circuits to prevent overdose. In this case, the patient's capaci~y to perceive pain would becorne the sensor. He would activAte a reed switch to signal the device. With kidney stones, an outflow catheter may be placed into the kidney pelvis itself, monitored and used to change the pH of this area to dissolve the stones.
Certain forms of epilepsy or perhaps several forms of mental illness may be more effectively treated with intraventricular 2~ medication or minute doses to a specific brain site. This medication in the case of epilepsy may be triggered by abnormal electrical activity. Other abnormal brain conditions may be treated by trlggering off abnormal slow waves (in the awake state) or by programs to maintain certain forms of electrical activity such as alpha waves or certain sub-cortical rhythms.
It, of course, should be understood that any of the central nervous system applications could only proceed ater years o careful experimentation.
In the case of certain spastic vascular disease such as Berger's or Raynard's disease, it now appe~ars feasible with ~3~

1 the present invention to accomplish a periodic lumbar or cervical sympathetic block with medication applied to this area. Medica-tion may be applied to the artery itsel~ by implanting the out-flow at the time of vascular surgery. Medication would be dis-pensed dependent on blood flow sensing.
Congestive cardiac ailure may be detected with sensors that pick up venous pressure and cardiac electrical activity, and controlled with diyoxin fed by catheter directly to the pericardial sac. In other conditions, depending on the results of extensive research, vasodilators may be dispensed to the pericardial sac by external patient control on the basis of angina or other perceived or sensed difficulties by the patient.
Finally, there are a variety of cardiac conclition~, especially cardiac arthythmias, that may be treated by dispensin~
medication into or through the pericardial sac in response to abnormal electrical signals from the heart. For example, the device of the invention may dispense quinadine in the supra-ventricular tachycardia condition based on the electrophysio-lo~ical activity of the heart. This example is later disclosed to demonstrate the present application of the concepts describedabove in a specific device whose operation can be fully docu-mentea .
In summary, many potential applications present them-selves immediately and while many years of work will be required by many persons to fully develop the invention in all its ramifications, the basic concept is also immediately reco~nized as practical and useful. Those skilled in the art will reco~nize that the individual components required and the individual method steps required have been separately proven in other medical environments. It is the present invention, however, that combines -- 1~ --~3S~

1 such components and steps together to accomplish results and functions not heretofore achieved.

DESCRIPTION OF THE PREFERRED EMBODIMENTS
_______________.__~__ ___________________ The invention will first be explained in a broad context and in relation to certain applications following which reference will be made to construction details of specific components for practicing the invention, then finally one de-tailed application will be presented.
Figure 1 illustrates in block and schematic diagram form the basic components of an implantable system according tothe invention. In particular, there is provided a micro-power ~ource 28, a medieation storayc 29, a sensor 30, a dispenser control 31, and a dispenser 32. All of the components except sensor 30 are contained in an appropriate housing 33 which is implanted in the body of the persons being treated. Power for the system is pro ided by a ~uitable micro-power source 2B such e ~e~ e~/
as described inrUnited States Patent 3,692,027. The purpose of the sensor 30 in each instance is to sense some type physio-2~ logical, chemical, electrical, or other condition in the bodyat a particular site, and produce data which corresponds to the sensed condition at the sensed site. This data, according to the invention method, is then sampled and evaluated by an appropriate dispenser control 31, e.g., a logic circuit, and depending on whether the sensed data is or is not indicative of a need for medication, the dispenser control 31 will op~rate in a manner to cause the dispenser 32 to either remain off or to be operated to dispense some precletermined amount of medica-tion from the s~orage 2~ accorcling to the patient's neecls.
~eferring next to Figure 2, there is schematically illustrated a more specific and somewhat more complex applicati.on - 15 ~

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1 of the invention to cardiac monitoring and medication. The micro-power source, while not shown for simplification, should be treated as part of the Figure 2-6 systems. In the application of Figure 2, there is provided medication storage 40 and an electric potential sensor 41, such as employed in electroence-phalogram and electrocardiogram examinations. While indicated as a single sensor, sensor 41 could comprise plural, e.g., three or more, sensors. The sensed information is directed to an appropriate logic circuit 42 which is designed to screen the sensed data for key factors. Since logic circuits as such are known and within the skill of the art to design, the description in general will speak more to the medical aspects than to the precise details of the circuitry, althou~h a morc complete circuit disclosure will be pro~ided in one example to be pre-sented later.
With further reference to Figure 2, it is known that sensed electric potential data such as obtained in electro-encephalogram and electrocardiogram examinations will reveal a plurality of factors. The assumption on which Figure 2 is based is that there are three ~actors A, B and C, which can be screened out and matched in appropriate subsidiary logic circuits 43, 44, 45 against normal limits. For example, subsidiary circuit 43 can match factor A as to whether it is or is not within normal limits (WNL) and produce a "no" or a "yes" ou~put accordingly.
Subsidiary circuits 44 and 45 can be designed for similar ~unctions with respect to factors B and C such that if factors A, B and C are all outside normal limits an output is produced at junction 46 and which can be used to control the dispenser ~7. Other combinations are possible. All of the components ~xcept the sensor shown in Figure 2 should be noted as being enclosed in a suitable implantable housing 48.

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To illustrate a ~urther application, reference is made to Figure 3 which is directed to a blood pressure monitoring and medication system. In this application~ there is provided a pressure transducer 51 which is connected to an appropriate logic circuit 52 contained in an implantable housing 50 and which is designed to make decisions on the basis of systolic and diastolic characteristics. If the blood pressure is not within the defined limits a "no" output is produced and which is used to operate a suitable dispenser 53 having medication selected from storage 54 to reduce the pressure.
In Figure 4 a ohemical monitoring systems is illu-strated. In this embodiment a suitable chemical level sensor 60 is employed and which, for example, may s~nse pH chancJes, ionic change~, glucose level or other body ch~mi~try factors susceptlble to sensing. The sensor 60 is connected to an appro-priate threshold discriminator and logic circuit 61 which in turn is connected to a medication dispenser 62 and all of which components except the sensor are contained in a suitable implant-able housing indicated by 63 which also houses the~storage 59.
In this application, the logic circuit 61 determines whether the sensed chemical f`actor is or is not within an acceptable threshold and, if not, operates the medication dispenser 62 to bring such factor within an acceptable threshold.
Making reference next to Figure 5, there is shown in block diagram form an application of the invention wherein dosages of the same medication may be dispensed from di~ferent sources. In this embodiment, the sensor 64 is connected to appropriate logic circuitry 65 which controls periodic sensing, evaluation of the sensed data and dispensing of medication ~rom a common medication storage 66 through a dispensing means 67 or a separate dispensing means 68. For example, dispensing means ~3~
1 67 may constitute a low volume, regularly dispensed medication whereas dispensing means 68 may be used for supplementary medi-cation at the same treated site.
In Figure 6, the sensor 70 is connected to the appro-priate logic circuit which controls a dispensing mechanism 72 for dispensing from a drug storage 73 having, for example, drug A. Circuit 71 also controls the dispensing mechanism 73 for dispensing from an alternate drug source 74, for example, drug B. In this application it can be seen that different medica-tions can be dispensed to the same or different treated sites with one medication being for one purpose and another medica-tion being for another purpose. Housing 76 encloses the apparatus~
Fxom the foregoing description, it can he seen that the various applications of the invention will each re~uire appro priate timing and sen~ing devices, appropriate circuitry for evaluating and making decisions about the sensed data, and appro-priate dispensing devices for dispensing medication subject to the evaluation of the sensed data. Implantable sensors for a great variety of purposes are well known and those skilled in 2~ the art will quickly appreciate their applicability to the broad concept embodied in the present invention. Those skilled in the art will also readily ascertain other types of implantable sensors which are suited and the required parameters for other types of sensors.
Considering next the type of logic circuitry required, given the concept of the invention, the design o~ such will be readily apparent to those skilled in the art. In general, the logic circuitry will be of a type in each application suited to receiving sensed data from a sensor, e.g., a transducer, in a form corresponding to the particular application, e.g., pressure ~L~3~ 4 1 data~ chemical data, electrical data, et cetera, and producing an output depending on the data evaluation. In some instances, as previously noted in connec~on with Figure 2 there may be a plurality of ~utput data on a single output which can be screened by different subsidiary circuits for different data, e.g., factors A, B and C, as in Figure 2. Miniature logic circuits of the kind required by the present invention may be found in both electronic design books as well as in medical literature, e.g., designs for demand pacemakers. Those skilled in the art will also readily appreciate the fact that the present inven-tion is of such wide scope that the logic circuit designer isgiven a wide choice in the types of circuitry which may be used to perform the logic functions.
Another important aonsideration concerns the implanta-bility of the sensor employed, the implantability of the housing which houses the medication storage and dispensing apparatus and the implantability of any catheter or other device employed to discharge the medication at the treated site. Since sensors, particularly electrical sensors, long term implanted diffusion devices, and the like, have all been used and the implanting problems are well known, th:e parameters required for implanting are considered known to those skilled in the art. Also, since pacemakers have been implanted, the general parameters for implanting a housing of the type required by the present inven-tion is also well known. The long term discharge of medication internally throuyh implanted catheters, and the like, fed by external sources of medication is also a current practice. Thus, tissue growth problems, tissue blockage problems, and the like, of the lcind encountered in prior practice~s are contemplated by the present invention and the same technology previously developed will be useful in the present invention.

Each application of the invention requires means for er~6~
storing a treating substance under pressure in ~4~e~e~, liquid, or other dispensable form, means for pumping or otherwise re-moving predetermined portions from such storage and means for directiny the measured dosage to the appropriate organ or site best suited to receiving the dosage. The amount of pressure may vary with the medication because of different viscosity, dose sizes, etc., and many arrangements known in the pumping art will suggest themselves. For example, the medication may be enclosed in an elastic sack by introducing an inert gas within the storage area to assert pressure.
The mosk immediately available device suited to the inve~tion fox stori~g and dispensing medication is illustrated $~ Ove ~e~ f~" e~/ ~S~, in my?p~ r Patent No- 3,692l027. For example, 3uch a device as shown in my prior patent may constitute the dispenser 32 illustrated in Figure 1 and the dispenser control 31 in Figure 1 may include a switch device connected so as to connect and disconnect the battery which is used to power the device of my prior patent. In this application, the sensor 30 of Figure 1 senses the particular condition at timed intervals and the dispenser control 31 of Figure 1 causes the dispenser mechanism, such as illustrated in my prior patent, to either operate or not operate according to the evaluation and decision based on the sensed data. Appropriate controls are preferably provided for in the circuit logic to prevent overdose if the sensed physiological change does not occur quickly enough in response to the medication dosage, e.g., appropriate timing delays or dose/
time functions.
The invention readily lends itself to a variety o~
dispensing mechanisms. Mention has already been made of the 1~380~4 1 mechanism described in my ~bove mentioned U.S. Patent No.
3,692,027. Another mechanism for pumping fluid medication is shown in Figure 7. In Figure 7 there is shown in a highly enlarged fo~n a housing 80 mounting a piston 81 secured to a bellows con-tainer 82 made of polyvinyl or other suitable material. A rod 83 attaches to piston 81 and is caused to move inwardly by an appro-priate solenoid 84 and to move outwardly by an appropriate spring 85 acting against a head portion 86 as schematically represented in Figure 7. Solenoid 84 is, of course, controlled by an appxo-priate logic control as previously explained. The bellows 82 receives medication through an inlet tube 87 and a one-wa~
valve 88 and discharges such medication through a one-way valve ~9 and a discharge tube 90. Xt ~hould, o course, be under~tood that the pump structure sho~n ~n F~guxe 7 wiil in practice be ; contained in the implanted housing previously referred to and has the particular advantage of not requiring a high friction producing seal between piston 81 and housing 80 since all medication will be sealed and confined to the interior of bellows 82. Bellows pumps as such are known and proven.
One problem co~non to man~ t~pes of physical disabi-lities is the need to dispense a daily average dose, e.g., insulin, on a regular basis and to dispense intermittently dosages for short acting drugs, e.g., insulin, when need arises. Figure 8 schematically represents a device suited to this requirement. In particular, cam 100 is driven by a suitable micxo-power motor such as shown in my above mentioned U.S. Patent 3,692,027 and which is arranged to be energized through an appropriate logic circuit, not shown. Rotation of cam 100 engages roller 101 and forces arm 102 to move piston 103 which cau-,es the bellows 104 to dis-charge from the drug storage area 105 a predetermined dosage 3~

previously obtained from a drug storage 106. As cam 100 rotates and after discharge bello~s 104 retracts and refills the chamber 105 at a suitable time the control for cam 100 causes it to stop. Appropriate one-way valves 107 and 108 control the intake and discharge. Such a cam driven arrangement may thus provide the required daily average dosages. For intermittent additional needs, a solenoid 110 is connected to the appropriate logic circuit, not shown, and when energized will move arm 111 and operate a piston 112 to provide a lesser amount than is obtained by cam 100 so as to provide a smaller dosage. Solenoid 110 is de-energized at the end of the discharge stroke and spring 113 causes the storage area 114 to refill.
In Figure 9 there is indica~ed an arr~ngement eor discharging two di~ferent types o~ medication. In Figure 9, cam 120 and solenoid 121 should be considered similar in their operation to the cam and solenoid operations previously expla.ined in connection with Figure 8. In the Figure 9 application, the cam 120 operates on the bellows 123 and solenoid 121 operates on the bellows 124. In the Figure 9, as well as in the Figures 7 and 8 dispensing arrangements, power for the respective drive members, e~g., rod 83, cam 100, is provided by the previously mentioned micro-power source. One type of medication, e.g., a long acting drug, may be stored in one storage reservoir 125 and a separate medication, e.g., a short acting drug, may be stored in a separate storage reservoir 126. Thus, one drug source may be dispensed by use o~ solenoid 121 and another drug source may be dispensed by the use of cam 120. It will, of course, be understood that appropriate one-way valves and other features of known mechanical construction may be employed even though not shown or specifically explained.

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7 In Figure 10 there is shown a reservoir arrangement comprising a bellows with two compartments 130, 131 housed in a common housing 132 and operated by a plunger piston 133. From the drawings, it can be seen that this arrangement, like that shown in Figure 9t provides for dispensing two or more types of medication to two or more body sites. The Figure 9 arrangement allows such medication to be dispensed to two sites at different pressures using two power sources whereas the Figure 10 arrange-ment provides for the medication to be dispensed to two or more sites at unequal pressures using only one power source. In addition, the multiple chamber bellows of ~igure 10 provides for a two or more drug dispensing capability without the greatly increased friction of more cylinders and piYtons. The bellows chamber in addition to its se~ling functions al.lows for a variety of options at the time of implanting suryery simply by substitu-ting various bellow configurations in the pump. This means that the surgical facility does not have to maintain many types of moxe expensive total pump configural changes. It is antici-pated that a large variety of bellow shapes and sizes will be 2~ found useful and which can be substituted in the pump cylinder for a multitude of treatment purposes.
In Figure 11 there is schematically shown a system of a type which corresponds with the type of application diagram in Figure 6. ~lere again it should be understood that the schematic diagram in Figure 11 would, in practice, correspond to a device of substantially less ph~s.ical size. In particular, there is represented in Figure 11 a housing 150 having appro-priate suture anchors 151. Within the housing 150 there is provided an appropriate compartment 152 for holding some pre-determined amount of medication intended to be released over a ~3~ 4 long term for a chronic situation requiring regular dosages whose size can be predetermined and scheduled. The compartment 153 represents a storage area for special medication such as might be required by unusual and transient conditions in a specific patient. The previously mentioned evaluating and control cir-cuitry is indicated as being confined in a separate compartment 154 and which is connected to an appropriate sensor 155 located within the body being treated but external of the housing 150.

For the ~imed medic,atioO/a micro-powered unit 160 of the type ~~e ~e" ~ e shown in my~ 4~ Patent No. 3,692,027 is controlled by the circuitry in compartment 154 and when indicated by evaluation o~ information coming from sensor 155, unit 160 turns on and rotates the cam 161 thus driving the cam peaks ayainst roller 180 attached to the shaf~ of piston 162 80 as to discharge the medication confined in the storage area 152 through an appro~
priate discharge tube 164. During discharge the flap valve 170 closes as piston 162 moves to the right in Figure 11 and a sliding cylindrical valve member 171 moves upwardly in Figure 11 so as to allow communication between pipes I75 and 176. As cam 161 con-tinues to turn roller 180 continues to ride on cam 161 by reason : of spring 181. Flap 170 opens, sliding ~alve 171 moves down and a new charge is stored in the storage area 163. Portals 158, 159 p.rovide for refilling.
When there is a demand for special medication as determined by sensor evaluation with the logic circuitry in compartment 154, solenoid 190 is energized which causes piston 191 to move to the left in Figure 11 against the tension of spring 1920 Ylap valve 193 closes, sliding valve 194 rises as shown in Figure 11 and pipes 196 and 197 are placed in communi-cation to allow discharge through pipe 164. On the return stroke 2~ -~3~
1 sliding valve 194 moves down, flap valve 193 opens and a fresh charge of the special medication is drawn into the storage area 200. Thus, by energizing and de-energizing the power unit 160 the treated body can be provided with the periodic timed medi-cation and by energizing and de-energizing the solenoid 190, the treated body can be provided with the special medication.
There is next given a more detailed disclosure directed to a cardiac pump mechanism to dispense medication for prevention of recurrent tachycardias. As background, it should be noted that ~ quinidine is given on a chronic basis for the prevention of re-currences of atrial fibrilation and flutter as well as supra-ventricular tachycardias not due to digitalis toxicity. Quinidine is also effectively used, as well as procainamide, in prevention of recurrences of ventricular tachycardia. Quinidine ls also used to prevent recurrences of ventricular fibrilation except when ventricular fibrilation occurs during complete heart block in which case it is contraindicated. A discussion o~ treatment o~ caxdiac arrythmias can be found in "Drugs used in the Treat-ment of Cardiac Arrythmias" in Treatment of Heart Disease in the Adult, 2nd Edition, Rubin, T.L.; Gross, Ho; Arbeit, S.R., Lea and Febriger, Philadelphiat pp. 297-324, 1972. One of the difficulties in using these ~rugs is that the therapeutic index, the ratio of therapeutic dose to toxic dose, is quite low. The pump feedback system of the invention is, however, adapted to carefully monitor the state of the heart and toxic manifestations of the drug and maintain the drug dosage at a level designed to minimize, if not eliminate, complications attributable to the medication. Thus, the device and method of the invention allows more general use of these medications in what are quite severe and life-threatening conditions of the heart. The invention is ~.~3~
1 directed to what is needed, namely, a feedback evaluation system that will provide for the maximum needed therapeutic dose that can be maintained below the toxic manifestations of the drugs.
The described goals can be accomplished by monitoring the disease condition and regulating the medication to treat the condition according to the invention and yet steering clear of the toxic manifestations of the drug by monitoring and regulating the dose in relationship to these manifestations also. The disease entity to be treated as an exa~ple is the supraventri-cular tachycardias. The present example is dire~ted to counter-pointing the heart rate against the toxic changes produced by ~uinidine, that is widening of the QRS Complex (a component of the electrocardiogram). The dose of ~uinidine can thus be moni-tored by use o the invention and reduced when there is prolonga-tion of the QRS complex which occurs as the dose of quinidine begins to reach the threshold for toxic effects.
Figures 12 and 13 demonstrate the basic construction and operation of the device to be used with supraventricular tachycardias treated with~dispense~quinidine. The pump motor 2 O a~ o ue ~e o ~e ~ 6~.S~.
210 is of the type shown in my~Patent 3,692,027 an~ is set to turn the equilateral cam 211/ e.g., eight or more revolutions per day, thus providing a total of 24 potential cam pump activating contacts with the roller 230 which operates piston 212O Thus, the pump can potentially operate every hour of the day providing for 24 potential doses per day. Using this paradigm provides the following options, if one operates on a two-hour dispensing schedule, that is dispensing medication every two hours unless altered by decisions based on evaluation of the sensors ~the two-hour schedule is accomplished by turning off the pump motor 210 every other hour). 1. The mechanism - ~6 -~.~3B~4 1 would dispense evexy two hours as an average dose timing. 2.
Depending on the feedback evaluation, it may suppress a dose of medication for two hours thus leaving a four hour interval between doses when this is indicated. 3. Extxa doses can he dispensed on a one hour schedule if needed. In actual operation the movement of pump motor 210 will turn the cam 211 and dispense the first dose. Then the timing mechanism cuts off the mechanism for one hour unless conditions require that an extra dose of medication be provided and in this case the mechanism is designed to continue to operate for the next hour to provide an extra dose. Thus, under normal operating conditions, the mechanism will provide 12 daily doses every two hours. Should toxic conditions of quinidine maniEest themselves, th~n the mech~nism may be cut off for su~ficient time to increase the interval between medications to four hours.
In actual practice with a supraventricular tachycardia, the electrodes 250 shown in Figure 13 on the heart itself pick up electrical activity of the heart and conduct the heart signals to amplifiers in the electronic package by wires 251 embedded in 2 the catheter 248. An electronic logic recognition program provides for identification of the QRS complex and another pro-gram subsequently quantifies the QRS period and R-R interval as described in relation to the chart shown in Figure 17. Opera-tionally, the cardiac frequency (R-R interval) is monitored and averaged for each hour over the 24 hour period and stored in a register. The lowest frequency average for an hour during the 24 hour period is compared with the lowest frequency hour from control periods as to whether this has increased by 10 to 20 percent over criteria control levels which criteria are set at time of implantation. Thus, if the frequency has increased by 1 20 percent, then the mechanism will provide three extra one hour doses every 8 hours for the next 24 hours. The decision-making control logic in the system provides for this operation.
The contrasting concern, that of quinidine toxicity, is monitored by the QRS period. The QRS period is sampled and evaluated each hour and if it increases over criteria levels (% of control~ or if premature ventricular contractions develop (indicated by very wide QRS complex over 150% of control) especially with the quinidine effect controlled, then the next dose period is tO suppressed by cutting off the power to the pump motor 210 and secondly stops the extra dose for that 8 hour period that is currently operational because o~ the criteria provlded for in the first series of ~eedback optlons.
~ he chart depicked in Figure 17 is explained as follows:
Condition I = Normal operation-pump operates every two hours on even hours.
Condition II = Cardiac frequency has increased by 10-20% which actually means the R-R interval has decreased by 10-20~. In practice, the hour with the 2~ lowest frequency for the previous 24 hour day is co~pared with the control value to ma~e this decision. Then, if this 24 hour lowest hour frequency is 10-20~ higher than control, the logi.c provides for three extra doses the next day given every 8 hours at 1, 9, and 17 hours.
Condition III - The sampled QRS period over the past hour is greater than criterion levels on the following basis; the QRS complex period is sorted on the basis of p~rcent of control value and g.iven a 3Q weight in the following schedule:
1) 110% or less than control value given weight of zero;

- 2~ -3~

- I 2) 110-120~ greater than control value given weight of one;
3) 120-130% greater than control value given weight of two;
41 130-150% greater than control value given weiyht of eight;
5) Greater than 150% of control valile indicates ventricular premature contraction and is given a variable weight of eight or sixteen.
If over the hour, out of the 256 sampled QRS
periods the weights add up to 256 or greaker, then the pump is turned off ~or th~ next even hour op~ration ~nd ~econdly stops the extra dose for that eight-hour period that might be currently operational because of criterion provided for in condition II. Thus, if the hour 4 dose was deleted, then the dose pro-vided for at hour 9 would be deleted also.
Other aspects of Figures 12 and 13 that require explana-tion are the three input portals 252, 253, 254. Input portal 252 represents an eight position rotary switch and a needle contact. The rotary switch and needle contact operates by use of a solid core needle, not shown, with a round to triangular to round O.D. (outside diameter) tip sectiOn which is inserted into portal 252 which has a mating triangular hole as shown. Opera~ion of the switch is accomplished by turning the needle through one to ~ight of the various positions. Contact to the switch function are through contacts on the three triangular surfaces o the needle approximated to the triangular hole contacts. The leads to the needle triangular surface are conducted down the long axis of the needle and are shielded by a suitable isoelectric ~ 2~ -material. Position No. 1 of the rotary switch provides for battery recharge through the needle contacts. Position 2 pro-vides ~or monitoring the electrocardiogram from the implanted electrodes. Position No. 3 provides for stimulation througn the cardiac electrodes if pacemaking functions are needed. Position No. 4 provides for contact with the logic system for calibration of the logic of the cardiac response parameters. Position No. 5 provides for monitoring the logic output and number of doses per day. Position No. 6 provides for cutting off of the entire system. Positions Mos. 7 and 8 are for future options.
Catheter access portal 253 is a bypass catheter inlet and provides the following functions: (1) It allows the physician to exert increased pressure if mechanical block occurs in the catheter. (2) It allows the physician to introduc:e a wire stylete if mechanical block occurs in the cathèter. t3) It allows the physician to introduce additional drugs into the pericardial sac if needed. The catheter access portal operates in a manner best explained by reference to Figures 14 and 14A.
A hollow bore needle, not shown, with a round to square to round :20 O.D. tip section is inserted through the patient's skin with the aid of protuberance 306 and thence into the square hole 303~
The square needle segment engages the sides of the square hole 303. Rotating the needle about its long axis rotates pinion 302, which is meshed with and rotates partial ring gear 301. When partial ring gear 301 has rotated to its counterclockwise limit portal 307 is in line with the I.D. ~inside diameter) of the needle allowing access to the catheter 304, and the pump output port 305. "O"-rings 308 and 309 seal the port .in both opeh and closed configuration. Pinion 302 is held in position by top plate 310. In Figure 14, the external casing of the device is represented by line 311.

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1 For purposes o~ replenishing medication, the input portal 254 is employed. Since the introduction of pressurized ~ replenis,hing medication has been previously discussed in my ,~,"~,~,,.','! ' ~o6~e ~,0~7 e ~ ~S~ .
Patent 3,692,027 and a suitable portal struc~ure described, no further detailed description o~ this operation or of the refill portal is deemed necessary.
Figure 13 shows in ~urther detail the bypass system with the details of the attachment of the catheter system to the pericardial sac. 0-rings 255 beneath the entry portal are provided for sealing purposes. A one-way valve 256 in the catheter leading to the pump provides ~or block o~ any increased pressure in the bypass system into the pump mechanism. The catheter system is sewn into the pericardial lining with a ring 247 embedded in the catheter 248 having both a uni,form ca~heter section and an appended expanded catheter section in the form o~
a trumpet 249. The expanded catheter diameter provides for increased surface area and reduces any blockage due to the fibrosis around the exit portal to the catheter. Also shown adjacent catheter 248 are leads 251 leading from the pair of sensing electrodes 250 to the amplifier and logic system~ These are actually embedded in the catheter and provide additional support for the catheter. The electrodes 250 and attached wires are emhedded in a polyvinyl shield after their exit from the catheter.
A block diagram describing the general operation and decision making involved in control of the cardiac medication pump is illustrated in Figure 15. The depicted "electrode sensor" and "amplifier" are intended to represent standard, devices such as are used in present cardiac pacemaker circuits.
The remaining portion of the block diagram of Figure 15 is the "brain" of the system and provides control to the "pump" based ~3~

on the presence of conditions I, II or III, as previously described. The type and nature of components required for the ~igure 15 circuit are generally known ana have been else-where indicated. ~herefore, since Figure 16 represents a more detailed description of Figure 15, it is believed those skilled in the art will readily understand the circuitry and operation depicted in Figure 15 after reading the description to follow.
The description now turns to a description of Figure 16 which constitutes a logic flow c ~ t suited to the application related to Figures 12-15 and 17. Since the components in Figure 16 are identi~ied and are known to those skilled in the art and their relation in the circuit is shown, the description will next concern itself primarily with the operation o~ the circuitry of Figure 16. The "Possible QRS-Complex Detector"
with output at ~a) detects the beginning and end of all "possible"
QRS-complexes. The start of a "possible" QRS-complex is detected by the "Possible QRS-Complex Start Detector" with output at (b) and the end of a "possible" QRS-complex is detected by the "Possible QRS-Complex End Detector" with output at (d). The decision of whether the "possible" QRS-complex that is detected is a "true" QRS-complex is made by the "True QRS-Complex Detector"
with output at (c). The outputs at (c) and (d) are then combined through an And Gate with output at (e). This output (e) represents the end of a "true" QRS-complex.
The QRS-complex is analysed in two different ways:
~1) Measurement of the time period of the QRS-complex; and (2) Measurement o~ the time pexiod between two consecutive QRS-complex, i.e., R-R interval.

The measurement of the time period of the QRS-complex is accomplished through the "Per Cent Control-Time Classifier".

1 The signal at (b) is the signal to reset and then start this classifier which classifies the time period of a QRS-complex into one of five time intervals: (I) 110~ or less of control time, (II) 110% of 120% of control time, (III) 120% to 130~ of control time, (IV) 130% to 150% of control time, or (V) 150 of greater of control time. The control time is the time period of a normal QRS-complex for the given patient. The signal at (f) occurs at the end of a "true" QRS-complex once every 256 times an hour. The pulse at (f) is the signal to add to the "Accumulating Counter For QRS Time Period". Depending on the percent of control time classification o~ the QRS-complex, this counter is incremented by 0, 1, 2, 4, 8, or 16 counts.
~ach classification adds a se~ number to the courlter. Class-ification (V) has the additional opt.ion of having its count value changed to 4, 8, or 16 through "Memory Latch Control 1".
Thls memory latch control can be set through the previously mentioned externally accessible rotary switch 252, not shown in Figure 16 but shown in Figures 12 and 13. If the count on the "Accumulating Counter for QRS Time Period" exceeds 256 in an hour then the output at ~g) is a logic "one" otherwise (g) is a logic "zero"~
The measuremen-t of the R-R interval is accomplished by the "R-R Pulse Generator" which selects two consecutive "true" QRS-complexes once every 256 times an hour and outputs a logic "one" pulse at "h" equal in length to the time period between the end pulses of these consecutive "true" end pulses.
This pulse at (h) is then gated through an And Gate with a 1000 Hz. clock and the resulting pulses at (i) represent the number of 1000 Hz. pulses occuring during a R-R interval once every 256 times an hour. These pulses at (i) are accumulated by the ~$3~
Interval Counter" with output at (j). At the end of each hour the contents of the "R-R Interval Counter" is compared with the "R-R Control Value". This control value represents the number of 1000 Hz. pulses that occur during a time period that is 20~ less than a normal R-R interval for a given patient (i.e., a time period corresponding to a R-R frequency 20%
faster than normal). This control value is set through the previously mentioned externally accessible rotary switch 252 into "Memory Latch Control 2". If the hourly count is greater than the control value then the "present Day R-R Status"
(which is normally a logic "one") is set to a logic "zero".
Once set to logic "zero", it remains at logic "zero" for the remaining portion of the present day. At the end o~ the 2~th hour this value i5 stored in the "previous Day R-R Status" for use in making the present day's pump decisions at the beginning of hours 1, 9, and 17. This output at (k) is a logic "zero" if any hourly ~R interval count for the previous 24-hour day was greater than the "R-R Control Value" for a given patient (i.e., if the average R-R frequency during any hour of the 24 hour day was slower than the 20% greater than normal control value).
The two outputs at (g~ and (k) control the pump operation. Normal operation causes the pump to dispense at all even hours (Condition I in the Figure 17 Chart). Increase in frequency for the lowest "hour frequency" for the 24 hour period of the previous day (indicating need for more medication), a logic "one" at (k), provides for the pump to dispense additional doses at hours 1, 9, ~nd 17 (Condition II in the Figure 17 Chart).
These two operations occur in the following manner. If either the output at (n) or (q) is a logic "one" then the input to the "Pump Control" is ~ logic "one" at (r). A logic "one" pulse at - 3~ -3~4 (r) is the signal to turn on the pump. This signal at (r) is a logic "one" at even hours ~output (m)), normally, and at hours 1, 9, and 17 (output (p)) under Condition II of the -Figure 17 Chart unless these conditions are altered by one of the followiny restraints: If the output at (g) is a lo~ic "one"
for any hour then the output of the "Two Hour Memory'' at (1) is set to a logic "zero" for the next two hours (normally this out-put at (~) is a logic "one"). This signal (1) is gated with the even hour pulse at (m) through an And Gate with output at ~n). If the output at (g) is a logic "one" for any hour then the output of the "Eight Hour Memory" at (o) is set to a logic "zero" for eight hours. (Normally this output at (o) is a logic "one"). rrhis output at (o) is gatecl with the logic "one"
pulse at hours 1, 9, and 17 at (p) and the pulse at (k? through an And Gate with output at (q).
With the foregoing in mind, it should be noted that the power unit 210 of Figures 12-13 and which is associated with the Figures 15-16 circuitry, is appropriately geared to operate on a fifty minute hour in contrast to the 60 minute hour for the logic circuit. This allows ten minutes between the end of the power unit hour and the end of the logic system hour which allows for any margin of timing error in the power unit move-ment due to increased work load.
In summary, there has been described an implantable system and method specifically useful for treating the human and animal body in a unique way. rrhe l'power source" may take ma~y forms. It may, be in the micro-power form referred to in ~,~ ~O"e ~e~ ~,~ ~ e~ c~S`.
my~p~G~ Patent 3,692,027 or in other equivalent miniaturized forms providing a long life, i.e., measured at least in terms of days and preferably years, source of electrical energy, for energizing the system electronics and for providing power for ~.~3~
1 the drive member used to actuate the dispensing mechanism. The apparatus lends itself to a wide variety of applications and the medication may include pharmacologically active drugs needed, body constituents, energy compounds, radioactive materials, and the like.
It should also be noted that the term "body" and "animal body" as used in the claims are intended to include animal, human and other living bodies. Further, the term "body" is intended to encompass any environmental body, whether living or otherwise adapted to receiving a sel~, micro-powered and timed device for incremental dispensing of substances into such body.

Claims (19)

    The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

    1. A self-contained and powered apparatus adapted to be totally implanted within a selected animal body, including human, for periodically evaluating selected internal physiological states of such body and for periodically dispensing selected medication therein according to such states while leaving the body ambulatory at all times, comprising:
    (a) a unitary housing adapted to be completely implanted and secured within and to the body at a selected site and having therein various compartments enclosed by said housing and adapted for mounting a medication storage member, a micro size power source, miniaturized driving and dispensing means adapted to being powered by such source for dispensing medication from such storage member, miniaturized electrical data evaluation and timing circuit means adapted to being powered by such source and to processing physiological data including data obtained from sensor means external of the housing to control the operation of said driving and dis-pensing means and said housing being further adapted to receive connections from external sensor means through the wall of the housing;
    (b) a storage member mounted within the implanted housing and adapted to store selected medication to be dispensed in selected quantities;
    (c) a micro size power source mounted within the implanted housing and secured proximate said storage member and having a useful working life in terms of at least several days;
    (d) miniaturized electro-mechanical driving means mounted within the implanted housing and adapted for being connected to and powered by said source;
  1. Claim 1 continued ...

    (e) miniaturized dispensing means mounted within the implanted housing and connected to receive said medication from said storage member and adapted to be powered by said driving means at selected times and being adapted when so powered to with-draw from said storage member successive measured quantities of selected said medication and to discharge such medication from the implanted housing into said body;
    (f) sensing means selectively placed within said body externally of the implanted housing and adapted to produce sensed signals convertible to electrical data corresponding to a sensed condition within said body;
    (g) connector means connected to said sensing means and passing through the wall of said housing and adapted to transfer such signals to the housing to be processed therein;
    (h) miniaturized electrical data evaluation and timing means mounted within the implanted housing and connected to be ener-gized by said power source and comprising:
    (1) miniaturized electrical circuit means connected through said connector means to said sensing means and adapted to receive selected data from said sensing means and convert such data into an electrically processable form and adapted for electrically evaluating such sensed data at selected times; and (2) timing means operatively connected to said circuit means and providing electrical time base information thereto whereby said driving means is energized and actuates said dispensing means in coordination with selected evaluations.
  2. 2. An apparatus as claimed in claim 1 including catheter means placed within the body externally of the implanted housing connected to receive and transfer the medication discharged by said dispensing means to a selected treated site.
  3. 3. An apparatus as claimed in claim 1 wherein said drive means constitutes a solenoid having an armature and said dis-pensing means constitutes a solenoid armature operated dispenser.
  4. 4. An apparatus as claimed in claim 1 wherein said dis-pensing means includes a reciprocable bellows for receiving internally thereof, measuring and discharging said medication.
  5. 5. An apparatus as claimed in claim 1 wherein said storage member, dispensing means, sensing means and data evaluation and timing means are adapted for selectively dispensing plural sources of medication.
  6. 6. An apparatus as claimed in claim 1 wherein said drive means constitutes an electrical motor having a cam and said dispensing means constitutes a cam operated dispensing means.
  7. 7. An apparatus as claimed in claim 1 wherein said storage member, sensing means, dispensing means and evaluation and timing means are adapted to storing, sensing the need for and dispensing doses of plural medications.
  8. 8. An apparatus as claimed in claim 7 wherein said dispensing means is adapted to dispensing said doses of plural medications to separate sites within said body.
  9. 9. An apparatus as claimed in claim 7 wherein said dis-pensing is according to plural sensing schedules.
  10. 10. An apparatus as claimed in claim 1 including externally available portal means adapted for replenishing medication in said storage member.
  11. 11. An apparatus as claimed in claim 1 wherein said sensing means is adapted to sense and develop electrical signals corres-ponding to plural medical factors and said data evaluation and timing means is adapted to electrically evaluate said factors and dispense said medication according to such evaluation.
  12. 12. An apparatus as claimed in claim 1 wherein said sensing means senses pressure within said body.
  13. 13. An apparatus as claimed in claim 1 wherein said sensing means senses an electrical activity in said body.
  14. 14. An apparatus as claimed in claim 1 wherein said sensing means senses a chemical activity in said body.
  15. 15. In an apparatus as claimed in claim 1 wherein said storage member stores a single medication, said dispensing means comprises plural dispensing means connected to a common said storage member and said data and evaluation timing means is adapted to evaluate the need for and to separately operate each said dispensing means to cause said medication to be dispensed independently through one or the other of said dispensing means.
  16. 16. In an apparatus as in claim 1 wherein said storage member, sensing means, dispensing means, data evaluation and housing means are adapted to sense the need for and to dispense a first medication on a regular timed basis and a second medica-tion on a special basis.
  17. 17. An apparatus as claimed in claim 1 wherein said dis-pensing means includes a discharge port and externally access-ible portal means enabling the entry of a suitable tool to clean said discharge port.
  18. 18. An apparatus as claimed in claim 1 wherein said storage member, sensing means, dispensing means and evaluation and timing means are adapted to dispensing medication in a wide range of combinations of single or plural doses, single or plural medica-tions, single or plural sensed conditions, single or plural sites, and under single or plural timing schedules.
  19. 19. An apparatus as claimed in claim 1 adapted to dispense medication for prevention of recurrent tachycardias and arrythmias and wherein said sensing means comprise a cardiac type sensor and said data evaluation and timing means includes an amplifying circuit connected to said sensing means, a first QRS detector circuit connected to said amplifier, a second QRS period analysis and control value comparison circuit connected to said first QRS
    detector circuit, an R-R interval analysis and control value comparison circuit connected to said first QRS detector circuit and said QRS period analysis circuit, an evaluating logic cir-cuitry connected to said second QRS period analysis and said R-R interval analysis circuit, a timing circuit connected to time said second QRS period circuit, said R-R interval analysis circuit and said logic evaluation circuit and wherein said dis-pensing means is controlled by said logic evaluation circuit.
CA225,432A 1974-04-23 1975-04-23 Implantable diagnoser and medication dispenser Expired CA1038044A (en)

Applications Claiming Priority (1)

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US463262A US3923060A (en) 1974-04-23 1974-04-23 Apparatus and method for implanted self-powered medication dispensing having timing and evaluator means

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DE (1) DE2544884A1 (en)
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