Abstract
A fully implanted automatic disorder response system is devised to act as a backup “immune” system, automatically detecting and dispensing an enzyme, for example, deficient due to an inborn error of metabolism. In response to a disease, the agent released is one or more drugs. By directly pipeline-targeting agents through a closed system of drug reservoirs, fluid and electrical lines, and leak-free, durable, and safe tissue connectors to the site of disease, the system achieves a level of efficiency critically superior to the systemic dispersal of an agent into the circulation, fundamentally liberalizing the use of drugs. In comorbid disease, each morbidity is assigned to an arm or channel in a hierarchical control system. Beginning with symptomatic indicia sensors, data is analyzed and passed up through successively higher-level nodes that generate a cross-morbidity view passed up to an implanted microprocessor which effectuates a release of drugs calculated to optimize homeostasis.
Claims
1. The combination of a closed system of implanted pipelines for directly pipe-targeting though secure end-connectors to target tissue, and an automatic control system which includes sensors to detect the need for therapy at each site which uses said closed system of pipelines to directly deliver medication respecitive of each site targeted and other forms of therapy such as electrostimulation as appropriate.
2. An implanted automatic control system according to claim 1, which includes sensors to detect analytes associated with disease processes and commands the delivery to the site of the disease process of therapy, usually pharmaceutical, determined by the control system to be optimal for each the disease process.
3. A system according to claim 1, wherein said automatic control system is organized hierarchically, so that the system is able to evaluate sensory data pertaining to each disease process, and by adding sensors for comorbid disease processes, progressively refer this data to higher level controllers able to coordinate the sum of this data and optimize therapy, usually pharmaceutical, for each of the disease processes detected as well as for the disease processes collectively, said system then commanding the directly targeted pipeline delivery to each disease to best affect each as well as the best combination of drugs and other targeted therapy to most closely approximate normal homeostasis across the combination of disease processes.
4. A primarily implanted automatic disorder response system that coordinates the data provided by a plurality of implanted sensors directed to a disease process and transmits its data to a microcontroller to determine the drug most efficacious therefor and controls the outlet motor of drug reservoir storing that drug to release the drug through a catheteric pipeline that isolates the drug from untargeted tissue directly into the blood supply of the affected tissue targeted.
5. A primarily implanted automatic disorder response system that coordinates the data provided by a plurality of implanted sensors directed toward one in a plurality of disease processes, these sensors transmitting their data to a microcontroller respective of the disease process aimed at by this set of sensors, other sets of sensors concurrently aimed at other disease processes likewise transmitting their data to microcontrollers respective of the disease process to which each set of sensors is aimed, the data then transmitted to microcontrollers at the level above said sets of sensors to integrate the data sets in order to determine which fewest number of drugs in the smallest doses will optimally affect the combination of disease processes, these microcontrollers then transmitting the results of their integration of the sensory data to a controller at the highest level, that of the master controller, which then controls the outlet motors of the drug reservoirs to release the drugs identified thus through catheteric pipelines to the sites of disease in the relative proportions that should exert the optimally efficacious affect on the combination of disease processes.
6. Pursuant to the automatic disorder response system according to claim 1, a plurality of ductus side-entry jackets and nonjackeing connectors wherewith at least one pump supplying fluid medicinals to said collars is controlled according to a prescription program by a microcontroller, such that: a plurality of physiological parameter sensors implanted at different locations in the body send outputs as subordinate negative feedback loop nodes in a hierarchical control system to said microcontroller as master node; these outputs represent feedback where each signals to the microcontroller an out of range condition that necessitates the prescribed medication; the microcontroller responds by causing said pump to index to and release the medication prescribed for that subordinate node in the dose proportional to the out of range feedback signal received; as master node, the microcontroller governs the discharge of the prescription program to include dispensing the medication through each subsidiary control loop as a subordinate node in a coordinated manner as governed by the prescription program so that dosing among the nodes is interrelated to achieve the optimal overall result on health; such a system overall thus able to treat comorbid conditions affecting different organ systems in a coordinated manner as an automatic homeostasis stabilizer and ambulatory prosthetic disorder response system.
Description
6. BRIEF DESCRIPTION OF THE DRAWING FIGURES
[0232] FIG. 1 shows right-hand pumps in a standardized pump-pair wherein line switching using turrets allows any drug or line rotated into alignment with the pump intake by the pump intake line switching means shown as a turret to be delivered through any one line rotated into alignment with the pump outlet by the pump outlet switching means also shown as a turret but without drug vials for simplicity.
[0233] FIG. 2 is a diagrammatic schematic or circuit diagram of the control train when a single pump-pair and jacket set is inserted in the pump-pack, shown in the abstract as to the positioning of the parts as inside or outside the body, the train constituting a hierarchical control system.
[0234] FIG. 3 is a simplified diagrammatic schematic or circuit diagram of the interconnections within a hierarchical control system and positioning as inside or outside the body when a second pump-pair and jacket set is added to the first in the pump-pack.
7. DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION
[0235] For pictorial representations and descriptive text explaining the various components used to implement a hierarchical automatic control system and their positioning in the body in detail, refer to copending application Ser. No. 14/998,495, entitled Nonjacketing Side-entry Connectors and Prosthetic Disorder Response Systems, FIGS. 12A and 12C. Here the fine details of system component materials and mechanical function have been omitted as duplicative of information already in the public sector as cited above in published copending applications.
[0236] For this reason, here the focus is directed to the implementation of these components in the context of elements in an automatic ambulatory disorder response system In FIG. 3, the distinction between system components which are fully, or closed-skin, implanted and others which are relegated to a usually belt-worn body pack is evidence that in this patient, the number of comorbidities and/or the expressions of each in different tissues was too numerous and complex than could have been comfortably diagnosed and responded to by a system comprised of components all of which would have been fully implanted. The preference for and realization of an automatic disorder response system usually allows the entire system to be implanted.
[0237] FIG. 1 shows line switching turrets at the intake and outlet lines of each pump, such that either or both inlets to each jacket can be switched to a different drug vial or reservoir. Control of this rotating turret mechanism is one means by which the master controller can position drugs for release to the targets. Depending upon the connections made between pumps and jackets, a pump or pump-pair can support one or more jackets, and more than one pump-pair can support a single jacket. In FIG. 1, the ductus side-entry jackets and lines at the top of the figure are described in copending application Ser. No. 15/998,002 entitled Ductus Side-entry Jackets and Prosthetic Disorder Response Systems where the same drawing figure appears as FIG. 32 and part numbers of the mechanism are identified and explained in detail.
[0238] When too small to provide the volume of medication required, the standardized drug vial shown in FIG. 1 for insertion into a turret drug vial receptacle serves as the connector attached to the end of a hose from the drug reservoir for engagement in the turret. The vial also provides the initial dose of the drug or another drug preparatory to delivery of the primary drug. A more usual and versatile arrangement is shown in FIG. 1, wherein one of the pumps in a pump-pair and jacket set is furnished with turrets at both its intake and outlet to allow any drug delivered through the intake turret to be sent to any jacket in the set. The two jackets represented in FIG. 1 as equal in size and distance from the pump might be placed along the same ductus, or ductus differing not only in size and/or distance from the pumpt but belonging to different bodily systems.
[0239] This might, for example, consist of a jacket placed along the digestive tract and another placed about the artery that supplies that segment of the tract, or each jacket might treat different diseases related or coincidental. Flexibility and speed in reconnection of the lines to and from each pump are often significant when line switching must be reconfigured quickly as during installation. In the arrangement depicted in FIG. 1, one of the pumps in a given pump-pair is used independently. The outlet of the other pump in the pump-pair could be plugged into the intake or outlet turret of the other pump; however, the need for such cross-feeding between pumps in a pair is exceptional. Cross-feeding to pumps belonging to other pump-pair and jacket sets is avoided as needlessly complicated as to invite errors.
[0240] Whereas lines supporting side-entry connection jackets placed along the vascular tree or the urogenital tract are small enough in caliber that placement should seldom encroach upon neighboring tissue as to cause pain by compression of a nerve or vessel, jackets placed along the gastrointestinal tract or airway might do so. Where anatomical or operative considerations discourage the placement of multiple lines to access a given jacket, the input line to each jacket is provided with a conventional miniature piggyback port with valve. FIG. 1 shows one of the two pumps in a pump-pair with switching mechanisms at both the pump intake and outlet to allow the sequential delivery of any drug to the mainline or sideline of any jacket.
[0241] In FIG. 1, crushed tacky hydrogel, drugs, drug hydrogels, and/or wash water for separate consecutive delivery to different jackets are delivered from one of the pumps in a pump-pair through the lines 13 and 11 and side-entry connector 6 of either jacket. Pump outlet flow lines (arms, runs) 11 are connected at intervals about outflow indexing turret plate 57, and pump intake lines 13 are connected at intervals about turret drug vials and/or vials used as drug reservoir hose connectors to pump intake sectional tray consisting of sectional tray 58 and hold-down plate 59. Each turret rotates one inlet vial or line into the in-line position at the same time that it rotates the preceding line out of the in-line position. Lines 13 and 11 are given enough slack that these do not interfere with rotation of the turrets.
[0242] FIG. 1 depicts the side-entry connection jacket at the top left as currently connected to pump 56, pump to turret outlet line 64 indexed, or switched by turret 57 motor 61 to the inline position, with accessory or sideline 11 connected to water jacket or accessory inlet 10 of that jacket. The lines of the jacket to the top right are not currently indexed to the pump inline positions and are therefore disconnected from pump 56. Pump 56 is continuously adjustable in speed and reversible, allowing outflow to and inflow from either jacket over the range of drug volumetric flow rates without the need to switch to lines of different caliber.
[0243] Pump 56 is usually one of a pair, one usually connected to the sideline. When more than one pump-pair is present, the connection of these to either jacket is through lines connected to the turret respective of each jacket. Reciprocally, jackets not shown in FIG. 1 may communicate with pump 56. The foregoing degrees of flexibility attest to a potential versatility able to respond to extraordinarily complex medical conditions. Pump and jacket relations are ordinarily simple.
[0244] To prevent air from entering the lines in vascular applications, turrets 57 and 59 omit blank vial positions that leave a line open-ended; rather, pumping is stopped once the amount of the infusate has passed when the hose can be disconnected. As shown, the left-hand turret lacks a vial and reservoir hose plug in table seen at 58 on the right, indicating that in this application, only the right-hand turret loads drug vials or receives medicated hydrogel or other therapeutic substance reservoir hoses. Were, however, drugs to be supplied from the turret to the left or a tacky medicinal hydrogel, for example, to be recirculated through the closed pump circuit with pump 56 when rotated clockwise, then the turret on the left would be of the same kind as that on the right. If to fill the line then stop or recirculate the gel, a reservoir hose would supply the gel necessary to fill the line.
[0245] FIG. 2 is a diagrammatic schematic diagram of the control train when a single pump-pair and jacket set is inserted in the pump-pack, shown in the abstract as to the positioning of the parts as inside or outside the body, the train constituting a hierarchical control system. FIG. 2 provides a schematic of the control hierarchy for a single pump-pair in support of four jackets in the pump-pair and jacket set, the control program, that is, the prescription-program, of the master node, a microprocessor, determined by the specific or comorbid conditions to be treated. Nodes subordinate to the master node are generally microcontrollers. FIGS. 2 and 3 provide a schematic of the pump-pack, jacket set, and control system. Unlike FIG. 3, in FIG. 2, only the control train is represented, the distinction between intra and extracorporeal elements omitted.
[0246] FIG. 2 provides a schematic of the control hierarchy for a single pump-pair in support of four jackets in the pump-pair and jacket set, the control program, that is, the prescription-program, of the master node, a microprocessor, determined by the specific or comorbid conditions to be treated. Nodes subordinate to the master node are generally microcontrollers. FIG. 2 provide a schematic of the pump-pack, jacket set, and control system. In FIG. 2, only the control train is represented, the distinction between intra and extracorporeal elements omitted. An extracorporeal pack affords considerably more space and can hold a larger volume of numerous drugs, other therapeutic agents, and equipment maintenance solutions. While shown as carried in a body pack, the control hierarchy is implantable with the impediment of a pack eliminated.
[0247] FIG. 3 is a simplified diagrammatic schematic or circuit diagram of the interconnections within a hierarchical control system and positioning as inside or outside the body when a second pump-pair and jacket set is added to the first in the pump-pack. An extracorporeal pack affords considerably more space and can hold a larger volume of numerous drugs, other therapeutic agents and equipment maintenance solutions. While depicted as a belt-worn body pack, the control hierarchy is implantable with the impediment of a pack eliminated.
[0248] When implanted, the contents labelled body pack at the lower left in FIG. 3 are miniaturized; otherwise, FIG. 3 applies no less to a fully implanted as to a body pack carry system. Also when implanted, to preclude complications due to encroachment upon or strangulation of tissue by wires, data intercommunication from the sensors and subordinate nodes and control signals from the master node are preferably by wireless, or Bluetooth transmission. For pictorial clarity, where the electrical and fluid lines between nodes and jackets are actually separate and distinct, those between nodes and jackets are shown as consolidated until finally led to each jacket, and remote sensors and auxiliary drug supply reservoirs have been omitted. Electrical connectors, more remote sensors, drug supply reservoirs and outlet pumps controlled by the master node have been omitted.
[0249] FIG. 2 provides a schematic of the control hierarchy for a single pump-pair in support of four jackets in the pump-pair and jacket set, the control program, that is, the prescription-program, of the master node, a microprocessor, determined by the specific or comorbid conditions to be treated. Nodes subordinate to the master node are generally microcontrollers. FIGS. 2 and 3 provide a schematic of the pump-pack, jacket set, and control system. Unlike FIG. 3, in FIG. 2, only the control train is represented, the distinction between intra and extracorporeal elements omitted. An extracorporeal pack affords considerably more space and can hold a larger volume of numerous drugs, other therapeutic agents, and equipment maintenance solutions. While shown as carried in a body pack, the control hierarchy is implantable with the impediment of a pack eliminated.
[0250] When implanted, the contents labelled body pack at the lower left in FIG. 3 are miniaturized; otherwise, FIG. 3 applies no less to a fully implanted as to a body pack carry system. Also when implanted, to preclude complications due to encroachment upon or strangulation of tissue by wires, data intercommunication from the sensors and subordinate nodes and control signals from the master node are preferably by wireless, or Bluetooth transmission. For pictorial clarity, where the electrical and fluid lines between nodes and jackets are actually separate and distinct, those between nodes and jackets are shown as consolidated until finally led to each jacket, and remote sensors and auxiliary drug supply reservoirs have been omitted. Electrical connectors, more remote sensors, drug supply reservoirs and outlet pumps controlled by the master node have been omitted.
[0251] If provided with the requisite switching and valving, the fluid and electrical lines shown as shared could support each jacket independently but not simultaneously, the utility thereof contingent upon the condition or conditions to be treated; simultaneous capability is accomplished by furnishing the components necessary. In FIGS. 2 and 3, single lines are electrical, or if it is found difficult to route the electrical lines without the risk of strangulating intervening structures, then connected by wireless Bluetooth transmission rendered selective by difference in carrier frequency. If virtually simultaneous operation cannot be achieved with a single carrier transmitter switching among the jackets, the microprocessor is provided with more than one transmitter.
