CN101495080B - Drug storage and dispensing devices and systems comprising same - Google Patents
Drug storage and dispensing devices and systems comprising same Download PDFInfo
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- CN101495080B CN101495080B CN200780008097.9A CN200780008097A CN101495080B CN 101495080 B CN101495080 B CN 101495080B CN 200780008097 A CN200780008097 A CN 200780008097A CN 101495080 B CN101495080 B CN 101495080B
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Abstract
Drug storage and dispensing devices for dispensing a drug dosage form to a patient are disclosed. The dispensing device has a programmable lock-out feature for locking the dispensing device and is capable of detecting the identity of a user. The invention further provides a method for the treatment of subject, by administering to the subject a drug dosage form using a dispensing device of the invention.
Description
The cross reference of other application
The application requires the priority of the U.S. Provisional Application 60/756,937 of submission on January 6th, 2006, and the full content of this application is incorporated this paper by reference into.
Technical field
The present invention relates to be used to the dispensing apparatus that gives pharmaceutical dosage form and the system that comprises this device.The present invention further comprises to be provided device, the lock-in feature that detects patient identity and prevents that unauthorized from approaching the dispensing apparatus of the device of the medicine of storing.
Background technology
At present, the standard medical device of repeatedly treating administration that is used under inpatient and out-patient's setting (comprising route of administration, preparation and dosage control) has clear and definite limitation aspect effect and the toxicity.
Controlled drug delivery and issuing technique have represented the initiatively field of research, and compare with existing drug delivery system, and controlled drug delivery system has dramatic benefit, comprises improved safety, and the patient better cooperates and convenience.
United States Patent (USP) discloses and has disclosed the system and method that is used for monitoring blood medicine concentration for No. 20050054942, and it detects the labelling in the expired gas after patient's medication with electronic sensor technology and reporting system.
United States Patent (USP) 6824512 discloses the closed loop system for detection of drug dose, suction and effectiveness, and described system comprises the pill sending trap that utilizes at least one transplantable medical treatment device to carry out data communication.This system comprises the data base of high-speed computer and relevant patient's history and device information.
United States Patent (USP) 6190326 discloses the system of collecting patient respiratory information, and it comprises base station unit and removable mouthpiece.
United States Patent (USP) 6039251 discloses the method and system that control as medicine transport the home medical apparatus of pump, wherein coding-control program or be used for " prescription " that device is controlled on portable cards.The data relevant with device can be kept on the card, and provide security procedure to guarantee the only having patient of mandate can use medical treatment device.Between medical treatment device controller and telecounter, provide long-range access by communication system.
United States Patent (USP) 5,752,620 disclose the tablet square law device, it comprises be used to the container that holds some tablets, and comprise that the tablet relieving mechanism is used for by air pressure tablet being released from the tablet clamping device, and detecting the granting of tablet by the sensor that is positioned at outlet, this process is by appended computer recording.Preferably, locking device is attached on the tablet dispensing apparatus to prevent the without permission granting of medicine.
United States Patent (USP) 5710551 discloses and has been used for the remote monitoring familial self and treats to guarantee the pharmaceutical dosage form table of abiding by the regulations.
United States Patent (USP) 5945651 discloses the medicine delivery system, and described system comprises that machine relatively little, microprocessor control is to assist the execution to the medical plan of doctor's formulation.Described machine can use separately, perhaps is integrated in the medicinal network of center-control.
United States Patent (USP) 5995938 discloses medical treatment and has comply with system, and described system comprises output device and the computer of communicating by letter with the output device that is used for Print Label.
Correlation technique is not described does not need opening and closing lid or other hinge hole with the dispensing apparatus of delivering drugs dosage form.
Although present obtainable medicine dispensing apparatus is effective in various types of medicines are provided, still need the device that is used for self-administration is improved to provide the convenience of improved safety and use, comprise: prevent unauthorized near the security feature of storage of pharmaceutical dosage form, stop lockout feature, the pharmaceutical dosage form technical characteristic of excessively putting medicine, the storage device that keeps relevant pharmaceutical dosage form delivery information, stop characteristic for the theft of hospital's theft, and with as another of computer install the interface of exchange message.
Therefore, for example be used to be in hospital and out-patient's treatment situation under treat the very large interest of existence in the development field of the improved device of short-term, drug delivery intermittently and during severe pain and system.
Summary of the invention
The invention provides for the dispensing apparatus to patient's dispensing medicament dosage form, wherein said device comprises the device of each granting multiple dose and single dose.
The application of dispensing apparatus of the present invention is not limited to medicine and the patient colony of any specific type.Similarly, dispensing apparatus of the present invention also can be applied to baby, adult and inhuman mammal treatment target delivering drugs.
The present invention further comprises for the dispensing apparatus to patient's dispensing medicament dosage form, and wherein this device comprises that at least one is filled with the cartridge case of a plurality of independent pharmaceutical dosage forms.
Medicine dispensing apparatus of the present invention can comprise the checkout gear for detection of patient or user identity.Typically, this checkout gear near dispensing apparatus and be designed to prevent chance or the interference of having a mind to, abuse or without permission individuality near pharmaceutical dosage form.
In some embodiments, dispensing apparatus of the present invention comprises anti-theft device to stop theft, and for example in hospital's situation, exemplary anti-theft device comprises and is attached to patient's RFID label with it and the RFID label reader in dispensing apparatus.
Medicine dispensing apparatus of the present invention also can comprise programmable lock-in feature, is used for the locking dispensing apparatus, so that dispensing apparatus can't be provided when locked.
Medicine dispensing apparatus of the present invention can possess the repeatedly ability of dispensing medicament dosage form.In this dispensing apparatus, drug administration mechanism provides device machinery or electric mechanical with the dispensing medicament dosage form.
Medicine dispensing apparatus of the present invention minimizes the device that saliva flows into dispensing apparatus in the time of can being provided to patient's dispensing medicament.
In some embodiments of the present invention, provide the device that between dispensing apparatus of the present invention and computer network, communicates.Medicine dispensing apparatus of the present invention can further comprise with this locality or remote computer system between two-way communication be connected, wherein, signal is provided computer system so that dispensing apparatus dispensing medicament dosage form.
In some embodiments, the invention provides for to patient's dispensing apparatus of dispensing medicament dosage form repeatedly, wherein, also provide to be used for control abuse or the accidental or access control apparatus of misuse unintentionally.The design of described dispensing apparatus is so that authorized person only could activate this device such as patient or health professional.
In some embodiments, the invention provides for to patient's dispensing apparatus of dispensing medicament dosage form repeatedly, described pharmaceutical dosage form is used for the oral transmucosal administration, and for example, wherein pharmaceutical dosage form is
Its size is selected from the group that comprises following size, volume is from roughly 0 to 100 microlitres roughly, and quality is from roughly 0.01 to 100 milligram, diameter is from roughly 1.0 to roughly 30.0 millimeters, thickness is from roughly 0.25 to roughly 10.0 millimeters, and density is from 0.01 to 2.0 grams per milliliter roughly.
In an illustrative embodiments, by adopt dispensing apparatus of the present invention to treatment target provide dose therapeutically effective the small size medicine or
The invention provides the method for the pain that treatment can treat to treatment body issues end chamber transmucosal drug dosage form.Can adopt mechanical means, electric mechanical method and/or two kinds of methods to operate described dispensing apparatus.
In some embodiments, the invention provides for the dispensing medicament dosage form or use the as mentioned above system of dispensing apparatus.The pharmaceutical dosage form delivery system comprises drug delivery device, and described device is placed on pharmaceutical dosage form or drug alone dosage form and patient in the cartridge case with the checkout gear for detection of patient identity.
Description of drawings
Figure 1A is the sketch map of exemplary dispensing apparatus of the present invention, wherein said device is designed to space, the Sublingual delivering drugs dosage form to the patient who receives treatment, also show pictorial displays among the figure, the biometric patient identifies reader, provides button, user interface and holds the housing of providing cartridge case.
Figure 1B is the sketch map of exemplary dispensing apparatus of the present invention, and wherein said device is designed to space, the Sublingual delivering drugs to the patient who receives treatment, and wherein also shows the adapter of plugging into.
Fig. 1 C is the sketch map of exemplary dispensing apparatus of the present invention, and wherein said device is designed to space, the Sublingual delivering drugs to the patient who is in treatment, wherein also shows to provide reciprocator and provide end.
Fig. 1 D is the sketch map of exemplary dispensing apparatus of the present invention, and wherein said device is designed to space, the Sublingual delivering drugs to the patient who receives treatment, and also shows cartridge assembly among the figure; Set of cells; Processor and computer board; Antenna and antagonist storage chamber.
Fig. 2 is the sketch map for the medicine Storage Box of the dispensing apparatus of delivering drugs dosage form.
Fig. 3 A and 3B are for the sketch map of the exemplary dispensing apparatus that transmits the pharmaceutical dosage form of providing, and wherein show exemplary single medicine dosage form sending trap.
Fig. 4 A is for the sketch map to the exemplary dispensing apparatus of oral mucosa delivering drugs dosage form to 4D, wherein shows and minimize the device that saliva flows into dispensing apparatus to patient's dispensing medicament the time.
Fig. 5 and Fig. 6 are the sketch maps of providing the exemplary shape of end, and described granting end prevents contacting of one or more sealing members and dampness or wetted surface.
Fig. 7 A is the sketch map of exemplary mechanical locking device to 7D, wherein shows an exemplary locking mechanism.Fig. 7 A shows the stages of the locking mechanism of relevant dispensing medicament dosage form to 7D.
Fig. 8 A is the sketch map of exemplary drug administration mechanism, and described mechanism is used for the dispensing apparatus of delivering drugs dosage form, wherein shows to be in resting position cylindricality drug administration mechanism.Described drug administration mechanism comprises one or more cartridge cases, start button, motor, cam, desiccant, sealing member, sends sensor, alligator clamp and spring.
Fig. 8 B is the sketch map of dispensing apparatus among Fig. 8 A, and wherein drug administration mechanism, motor and cam are in resting position.
Fig. 8 C and 8D are the sketch maps of dispensing apparatus among Fig. 8 A, and wherein drug administration mechanism, motor and cam are in and fetch the position.
Fig. 8 E and 8F are the sketch maps of dispensing apparatus among Fig. 8 A, and wherein drug administration mechanism, motor and cam are in issuance location.
Fig. 8 G and 8H are the sketch maps of optics sense mechanism, and described mechanism sends for detection of the pharmaceutical dosage form of dispensing apparatus.Described drug administration mechanism comprises one or more cartridge cases, cam, desiccant, sealing member, sends sensor, alligator clamp.
Fig. 9 A shows the extra embodiment of the drug administration mechanism of dispensing apparatus of the present invention, wherein shows arrowband type dispensing apparatus.
Fig. 9 B shows and is in the drug administration mechanism of fetching the position among Fig. 9 A.
Fig. 9 C shows the drug administration mechanism that is in issuance location among Fig. 9 A.
Figure 10 shows the extra embodiment of the drug administration mechanism of dispensing apparatus of the present invention, wherein shows the drug administration mechanism that adopts dissimilar push rods and be in issuance location.
Figure 11 A shows the extra embodiment of dispensing apparatus of the present invention, wherein shows the dish-type drug administration mechanism that is in resting position.
Figure 11 B shows the drug administration mechanism that is in issuance location among Fig. 9 A.
Figure 12 A shows the exemplary push rod that is designed for the dispensing medicament dosage form to 12C.
Figure 13 and 14 shows other the exemplary drug administration mechanism with push rod for the dispensing medicament dosage form, and wherein push rod is designed to elastic.
Figure 15 A is the sketch map of exemplary lockout device to 15F, comprises putter type device (15A), the locking-typed mechanism of actuator type (15B), safety switch/dog-type mechanism (15C/15D), solenoid type mechanism (15E) and another kind of solenoid type mechanism (15F).
Figure 16 A provides the sketch map of exemplary cartridge case to 16D, and described cartridge case comprises barrel shape, rotating disk/spring loaded type, chucking type, rail type.
Figure 17 A and 17B are the sketch maps of dispensing apparatus of the present invention, show pharmaceutical dosage form by the sketch map of push rod promotion by sealing member, and wherein, the geometry of sealing member and pharmaceutical dosage form and push rod adapt.
Figure 18 is the sketch map of exemplary push rod, pharmaceutical dosage form and diaphragm type sealing member.Design example cut type diaphragm seal is to keep uniformly sealing around pharmaceutical dosage form and push rod in delivery process.
Figure 19 A is the sketch map of another exemplary cut type diaphragm seal to F, and it is designed in delivering drugs dosage form process, keeps the uniform sealing on every side of pharmaceutical dosage form and push rod.
Figure 20 A is the sketch map that comprises the exemplary architecture of reusable head, main body and charging station.
Figure 20 B is the sketch map that comprises the reusable head, can abandon the exemplary architecture of main body, POP and POP.
Figure 20 C is the sketch map that comprises the exemplary architecture that can abandon main body, portable POP and charging station.
Figure 20 D is the sketch map that comprises the exemplary architecture that can abandon main body and POP.
Figure 20 E is the sketch map that comprises the reusable head, can abandon the exemplary architecture of main body, portable POP and charging station.
Figure 20 F is the sketch map of exemplary architecture, wherein shows fully and can abandon main body.
Figure 21 is the sketch map of the function element of medicine delivery system of the present invention, and it comprises the medicine dispensing apparatus and with by monitoring and controlling equipment medicine network wireless or that other bidirectional communication network engages.Described system comprises battery powered microprocessor, described microprocessor comprises that RAM is connected with ROM and operationally is connected with the adapter of plugging into, and carry out communicating by letter with RFID antenna, WI/FI antenna two-wayly, wherein, medicine dispensing apparatus and medicine network further comprise user interface, audible alarm, pictorial displays, granting button and sensor, and provide button latch.
Figure 22 A is that the block diagram of communicating by letter related with medicine delivery system of the present invention is shown with 22B.System communication schematic diagram shown in Figure 22 A comprises RF identification (RFID) label, dispensing apparatus, base station/connecting device and health care provider personal computer.System communication schematic diagram shown in Figure 22 B comprises RF identification (RFID) label, dispensing apparatus, portable connecting device (or portable hand-held connecting device) and health care provider personal computer.
Figure 23 A and 23B show the exemplary shape of medicine.Figure 23 A is the sketch map of symmetrical pharmaceutical dosage form 368, comprising ellipse, the sphere of the disc of the plane, concave surface or convex surface, the plane, concave surface or convex surface, have 3 or polygon more polygon and plane, concave surface or convex surface.Figure 23 B is the sketch map that is the other medicines shape 370 of asymmetric pharmaceutical dosage form.
Figure 24 illustrates the configuration of medicine delivery system of the present invention and the block diagram of programming flow diagram, and wherein program may further comprise the steps: pharmaceutical dosage form amount cartridge case is loaded into dispensing apparatus.If load successfully; Close and lock dispensing apparatus; Dispensing apparatus and personal computer are plugged into; Dispensing apparatus is programmed; Record fingerprint or PIN (PIN) are with the suitable user of identification; The test dispensing apparatus.
Figure 25 is the block diagram that the operational flowchart of dispensing apparatus is shown, and the step-by-step operation example of medicine dispensing apparatus of the present invention wherein is provided.
Figure 26 is the block diagram that the operational flowchart of another exemplary dispensing apparatus is shown, and step-by-step operation second example of medicine dispensing apparatus of the present invention wherein is provided.
Figure 27 is the block diagram that the operational flowchart of another exemplary dispensing apparatus is shown, and step-by-step operation the 3rd example of medicine dispensing apparatus of the present invention wherein is provided.
Figure 28 illustrates by the health professional to carry out the block diagram that exemplary sending trap is disassembled flow chart, wherein provides medicine dispensing apparatus of the present invention progressively to disassemble example after use.
Figure 29 is the block diagram that the acute dispensing apparatus operational flowchart of exemplary inpatient is shown, and the step-by-step operation example of medicine dispensing apparatus of the present invention wherein is provided.
Figure 30 is the block diagram that exemplary inpatient sending trap configuration and assembling flow path figure are shown, and medicine dispensing apparatus of the present invention collocation in successive steps before use and assembling example wherein are provided.
Figure 31 is the block diagram that the chronic dispensing apparatus configuration of exemplary out-patient and assembling flow path figure are shown, and configuration and the assembly operation example of medicine dispensing apparatus of the present invention wherein is provided.
The detailed description of invention
The following discloses content description consist of dispensing apparatus of the present invention, system and method.The below provides the open in detail of the device for administration of the present invention, system and method.The present invention comprises generally: (1) medicine dispensing apparatus; (2) comprise the system of dispensing apparatus and pharmaceutical dosage form; And the method and system of (3) operation dispensing apparatus.
The present invention refers to provide any one dispensing apparatus in the multi-medicament dosage form by a plurality of different route of administration generally, uses the method for this dispensing apparatus and comprises the system of this dispensing apparatus.
In an illustrative embodiments, the invention provides a kind of like this system, it comprises: (1) is used for giving the dispensing apparatus of small size dosage form, for example
(2) small size peroral dosage form, for example
And (3) patient.
In aspect of this embodiment, the oral transmucosal delivery that dispensing apparatus of the present invention can be used for when pain therapy is sent the small size dosage form.In aspect this embodiment further, the invention provides method and system and the use when pain therapy of said method and system, for example acute pain, postoperative pain or the sudden pain of operation dispensing apparatus of the present invention.In an example of this embodiment, described dosage form is to comprise opioid such as sufentanil or its analog
Wherein said dispensing apparatus is used for treating the dosage form of pain.
The specific device that the invention is not restricted to illustrate here, system and method or combination are because it can change certainly.Be appreciated that also term used herein only is the explanation particular implementation, and be not intended to limit the scope of the invention.
Unless otherwise defined, all technology used herein have the identical implication of usually understanding with those skilled in the art with scientific terminology.Although in enforcement of the present invention or test, can use anyly to be similar to or to be equal to method as herein described, device and material, now will describe preferred method, device and material.
Have to be noted that singulative " a ", " and " and " the " comprise plural implication, unless context has clear and definite phase antirepresentation in this paper and appended claim.Therefore, for example, mentioning " pharmaceutical preparation " comprises a plurality of such preparations and mentions " drug delivery device " and comprise and comprise pharmaceutical preparation and be used for the system that holds, store and send the device of this preparation.
The full content of all publications of mentioning is herein all incorporated this paper by reference into, and its purpose is to describe and be disclosed in compositions and the method that can be combined with the present invention of describing in these publications.Provide publication discussed in this article only to be because its open submission day early than the application.Any content of this paper should not be interpreted as all admitting that the present invention does not have qualification prior to such disclosing owing to formerly invent.
Definition
Terms " formulation " used herein or " pharmaceutical preparation " or " pharmaceutical dosage form " refer to contain at least a for delivery to physical composition individuality, that any one therapeutic agent that provides in the multiple dosage form can be provided.Described dosage form can be used as lozenge, pill, capsule, film, bar, liquid, paster, thin film, chewing gum (gum), gel, spray or other form and offers the patient.
Term used herein " medicine " is often referred to any material that changes the zoophysiology feature.Described term " medicine " can use with term " therapeutic agent ", " medicine ", " pharmacologically active medicament " exchange.Be appreciated that " medicine " of the present invention preparation can comprise more than one therapeutic agent, wherein the example combinations of therapeutic agent comprises the combination of two kinds or two or more medicines.
Term " individuality " comprises any individuality, and normally mammal (for example, people, Canis animals, felid, equine species, bovid, hoof mammal etc. is arranged), adult or child wherein need to treat disease.
" through mucous membrane " of term medicine send etc. mean comprise through or all delivery form by mucosa.Especially, " oral transmucosal " of medicine sent and comprised through mouth, pharynx, larynx, trachea, upper respiratory tract or upper gastrointestinal any tissue, especially comprises sending of Sublingual, gums and maxillary mucosal tissue.
Term used herein " oral transmucosal drug delivery " refers to such dosage form, and wherein drug delivery occurs via the through mucous membrane approach substantially, and does not absorb by GI via swallowing then.This dosage form is designed to provide and allows the medicine dissolution rate sent via the oral mucosa maximum, and usually via described dosage form is placed the chamber, Sublingual.
" Sublingual " used herein literally means " tongue following ", and refers to the method for material via the mouth administration, and the mode of administration rather than is absorbed via digestive tract so that this material absorbs via ranine blood vessel rapidly.In addition, absorb and to occur via the height vascularization of oral mucosa, and absorb and allow more materials directly to enter blood circulation, thereby the administration that is not subjected to the immediate system that gastrointestinal affects is provided.
This paper uses term medical conditions or morbid state " treatment (treatment) " or " processing (management) " usually to describe disappearing, suppress or alleviating of disease, in order to make individuality more comfortable, for example determine by subjective criterion, objective criterion or the two combination.
Here it is accidental or intentionally turn to any other without permission or unscheduled individual's behavior or situation from predetermined patient usually to describe use with the use of dispensing apparatus and/or pharmaceutical dosage form to use term " to migrate ".
" holding and provide the device of dosage form " used herein or the fingers such as " delivery apparatus ", " sending trap ", " dispensing apparatus " are suitable for storing and/or any device of delivery formulation, and described formulation example is as being dosage form, pill, dosage form, lozenge, gel, chewing gum, liquid, bar or thin film.
" operatively connect " used herein means provides element in device, make it play a role like that to reach target according to expection.For example, storage device is operatively coupled to CPU, and CPU further is operatively coupled to relieving mechanism, this means once actuating, CPU then with storage communication to check state or the history of drug delivery, and further communicate by letter to discharge and dispensing medicament with relieving mechanism (for example, by solenoid or switch).
Term " portable connecting device (fob) " refer to small size, portable hand-held, active electronics plug into (docking) device, described device can be combined with sending trap, with uploading data, data download, control near sending trap, control near pharmaceutical dosage form or enhancing or change the user interface of sending trap.Portable connecting device can be communicated by letter and plug in wired or wireless mode with sending trap.Portable connecting device can connect cotton rope so that portable connecting device is suspended on the cervical region such as doctor or nursing staff's occupational health personage, especially in hospital's configuration.The medicine sending trap can be communicated by letter with doctor or nursing staff by portable connecting device.
Term " storage chamber " refer to send or storage device in chamber or enclosed space, in order to the to be delivered preparation of storage from delivery apparatus.
Here term " dispensing apparatus ", " medicine dispensing apparatus " and " drug delivery device " use with term " dispensing apparatus " exchange, and refer to provide the device of dosage form, and described device is enough little of to realize controllably sending and carry the medicine for treatment thing to the patient.Therefore dosage form of the present invention can be physically frangible and be not easy to carry out physical treatment.Described dispensing apparatus provides the mechanism with the medicine of dosage form preparation of the present invention of sending that is used for controlled and safety.
Term used herein " system that comprises pharmaceutical dosage form and dispensing apparatus " refers to the medicine delivery system that gives be used to sending and monitor medicine.System of the present invention can be used for monitoring and sending the medicine of strong effect and maximal dose, thereby for present obtainable system, has strengthened delivering drugs amount, corresponding effect and safety.Described system can have one or more features so that safety and the ease for use with respect to present obtainable system enhancement to be provided, described feature comprises the security feature that prevents without permission near medicine, the theft that helps to avoid theft stops feature, the dosage lock-in feature, the dose counting feature, be used for keeping the storage device that relevant dosage transmits information, and with user or other interface such as the device two-way exchange information of computer.
Term used herein " acute pain " refer to general occur be less than one month pain, yet, in some cases, if specific pain symptom self is shorter, lasts up to trimestral pain and also can be considered to acute pain
Term used herein " chronic pain " refers to usually lasting pain more than one month.
The type of dispensing apparatus
The acute setting of out-patient
An exemplary application of dispensing apparatus provides and can produce fast therapeutic effect and can be safely and the snap action dosage form used easily, and the therapeutic effect in appropriate time cycle is provided.Dispensing apparatus of the present invention can arrange lower use the out-patient.In the out-patient arranged, an embodiment of dispensing apparatus of the present invention can present following structural and functional characteristic: dispensing apparatus can be portable mode independently; Dispensing apparatus can reach the treatment of several weeks; Dispensing apparatus can be droppable, and/or non-recharging; Dispensing apparatus can prevent that child from using; Dispensing apparatus can have fixedly locked between dosage; Dispensing apparatus can fixedly shut down behind the duration at one; Dispensing apparatus can have and is limited to the interface of providing button, sound or the sound and light emitting diode (LED); If pharmaceutical dosage form surpasses margin of safety, then dispensing apparatus can monitor temperature and shutdown; Display device; And dispensing apparatus can have dose counter.
When configuration is lower out-patient acute (in the family, office, field etc.) when using, dispensing apparatus of the present invention provides with respect to some Characteristics and advantages that have out-patient's medicine granting field now.Described dispensing apparatus allows the individual according to the self-administration that instructs of doctor, health care provider or drug label.Some exemplary acute out-patient's signs comprise postoperative pain, the pain relevant with the health wound, anxiety, insomnia, hypertension, angor, coronary heart disease, depression, psychosis, constipation, vomiting, habit-forming, ADHD and other.For example can be with reference to the U.S. Patent application 11/429,904 of specially quoting at this.
For lower effectively auxiliary administration is set acute out-patient, described dispensing apparatus can provide part or all in the following feature: allow patient's self-administration; Recording medicine is historical; Allow to read medication history or medication history is sent to computer, network or other electronic equipments; Prevention is distorted or is migrated; With pharmaceutical dosage form be delivered to the appropriate location (for example, Sublingual, oral cavity, oral cavity gastrointestinal tract, rectum, eyes, nasal cavity, suction, ear, pass skin or with other any route of administration); And individual or individual colony (by alarm, warning, cellular telephone information, short message, Email or other wired or wireless communication device) that some event notice is predetermined, described event for example for administration, need to recharge specific drug, distort trials, store in the misuse of device, GPS position, device that medicine is expired, temperature or humidity situation.Dispensing apparatus of the present invention is used in the out-patient and arranges down, provides any medicine with any pharmaceutical dosage form, and has any combination of above-mentioned feature.Use the example of device of the present invention also to be included in the first respondent's acute open-air nursing, military open-air medical care, emergency relief etc.
For example, in " field " under the height Second Optimal Condition, must often carry out the treatment of acute pain.The first respondent, for example nursing staff or the doctor of army often are required to process serious acute pain under non-conditions for sterilization, and the entry needle that wherein uses in IV or IM administration can produce unexpected consequence, such as infecting etc.Dispensing apparatus of the present invention, system and method can this configuration under, and as the situation when treatment target just experiences angor under used, can treat angor by adopting dispensing apparatus granting nitroglycerine of the present invention.
Inpatient arranges
The another kind of purposes of device of the present invention appears at during inpatient arranges.For example, all need the fast treating acute pain under many different clinical settings, described clinical setting is included in post-operative recovery under the hospital configuration, rheumatic arthritis, back decline, terminal cancer etc.For example, after patient begins several days severe pain after surgery, can experience some days slight to moderate pain.
The embodiment that the dispensing apparatus of lower pharmaceutical dosage form is set at inpatient can comprise following structural and functional characteristic: the enough medicines that are used for treatment in 1 to 5 day; The droppable dispensing apparatus of droppable or part; Chargeable and have charging station/connecting device/portable connecting device dispensing apparatus; The dispensing apparatus that has pictorial displays on the device; The dispensing apparatus that can have POP or portable connecting device; The dispensing apparatus that can have keyboard on the device; Connecting device or portable connecting device; Can inquire about the dispensing apparatus of pharmaceutical dosage form history; Can the identification authorized user and have controlled approaching dispensing apparatus; The dispensing apparatus that can have the enumerator function of reset; Have and prevent the child dispensing apparatus of function; Dispensing apparatus with fixing or variable locking time; The dispensing apparatus that can recharge; Can carry out the dispensing apparatus of medication feedback; Can link to each other to carry out with wireless or cable network, device or computer the dispensing apparatus of real-time update; Has the dispensing apparatus that stops the theft function; And can have the reusable head.
When lower use was set, dispensing apparatus of the present invention had Some features and advantage with respect to the prior art of out-patient's administration at inpatient (hospital, clinic etc.).Described dispensing apparatus allows health care provider to provide pharmaceutical dosage form to carry out the self-administration of PRN (in case of necessity) treatment to the patient.PRN refers to the medicine taken as required, such as treatment pain, feel sick, constipation, anxiety etc.In order effectively at inpatient lower work to be set, dispensing apparatus by PRN patient's control should allow as required voluntarily medication of patient, and prevent that patient's overmedicate, recording medicine are historical, allow medication history readable, can download or be passed in patient's record, the delivering drugs dosage form to the appropriate location (for example, Sublingual, oral cavity, oral cavity gastrointestinal tract, rectum, eyes, nasal cavity, pulmonary, vagina, ear, pass skin or with other any route of administration) and prevent or stop without permission the individual near medicine.Dispensing apparatus of the present invention is used in the inpatient setting and issues the PRN medicine of letting alone what pharmaceutical dosage form, and any combination of above-mentioned feature is provided, can be with reference to the U.S. Patent application 11/473,551 of quoting.
The system that comprises dispensing apparatus of the present invention can comprise portable connecting device, described connecting device with wired or wireless pattern from described dispensing apparatus to network delivery information.In order to download to computer system or the software of uploading data also is the part of this embodiment of the present invention.
The chronic setting of out-patient
Another embodiment of dispensing apparatus of the present invention is under the chronic facilities of out-patient, in this case, needs chronic administration for the patient who stands the chronic disease misery.
The out-patient a lower embodiment that is used for the dispensing apparatus of delivering drugs dosage form is set and can comprises following structural and functional characteristic: dispensing apparatus can carry out the treatment of 1-2; Dispensing apparatus can recharge and be a part that comprises charging station/connecting device/portable connecting device; Dispensing apparatus can have pictorial displays and the display lamp that is positioned on the dispensing apparatus; Dispensing apparatus can be a part that comprises the system of connecting device or portable connecting device; Dispensing apparatus can comprise the keyboard that is positioned on the device; Dispensing apparatus can comprise connecting device or portable connecting device; Dispensing apparatus can record administration history; Dispensing apparatus can allow to inquire about medication history; Device can be stored one or more patient or user identity; Dispensing apparatus typically has the theft of prevention and child is used and controlled approaching function, and can have resettable counter; Dispensing apparatus can have fixing or variable locking time; Dispensing apparatus can recharge; Dispensing apparatus can be networked; And dispensing apparatus can have alarm function.
When lower use was set, dispensing apparatus of the present invention provided some Characteristics and advantages with respect to out-patient's administration field present situation out-patient chronic (in the family, office, field etc.).Dispensing apparatus allows the individual to carry out self-administration according to the guidance of doctor, health care provider or drug label.The example that dispensing apparatus of the present invention is applied in the chronic patients case comprises chronic pain, chronic explosive pain, anxiety, insomnia, hypertonicity, angor, coronary heart disease, depression, psychosis, habit-forming, hyperkinetic syndrome, hypertension, diabetes and other.For effectively auxiliary administration in chronic patients arranges, dispensing apparatus can have part or all of following feature: dispensing apparatus can allow patient's automedication; The medication of record patient is historical; Allow medication historical readable or be sent in computer network or other electronic installations; Allow doctor or health care provider to revise configuration and in local or remotely programming; In the scheduled time, show on schedule or according to particular event, automatically upload or transmission information; Prevention is distorted or is migrated; With pharmaceutical dosage form be sent to suitable position (for example, Sublingual, oral cavity, oral cavity gastrointestinal tract, rectum, eyes, nasal cavity, suction, ear, pass skin or with other any administering mode); And individual or individual colony (by alarm, warning, cellular telephone information, short message, Email or other wired or wireless communication device) that some event notice is predetermined, described event comprises dispensing medicament, need to recharge prescription drug, distorts trials, store that medicine is expired in the misuse of device, GPS position, device, temperature or humidity situation.Dispensing apparatus of the present invention is used in the out-patient and arranges down, provides any medicine with any pharmaceutical dosage form form, and has any combination of above-mentioned feature.
In some embodiments, dispensing apparatus comprises plug into adapter or wireless connecting device, and can with comprise software and the access computer network system communication.The system that comprises this device has static and portable POP, the device that described POP utilization is plugged into adapter or wireless connecting device and is connected to telephone wire, computer or network, with information from described device two-wayly by wired or wireless mode or radio hookup to network delivery.
The physics aspect of dispensing apparatus of the present invention
Exist always and not yet be met for demand from the medicine of specified rate to correct patient that can be accurately provide, described releasing mode has cost benefit, minimized error risk, energy stops chance and the abuse of having a mind to and migrates, do not need to process medicine, and be not labor-intensive.
In another embodiment, dispensing apparatus provided by the invention has been simplified the process of providing the given medicine of single dose and multiple dose under controlled condition greatly.An exemplary application of dispensing apparatus of the present invention is giving such as the controlled drug of opioid.In this case, dosage form comprises efficient and controlled anesthetis, and it must store under controlled condition and give.Store and send this class medicine and need specially designed device.Described device must be stored dosage form safely, prevent or stop abuse or accidental or unintentionally misuse, only provide independent dosage form to the patient immediately and accurately, wherein leave described medicine in efficient and safe mode as described patient, and this device also must be provided for monitoring and reporting the device that uses history.Dispensing apparatus of the present invention has satisfied these demands.
In another embodiment, dispensing apparatus comprises and holds shell single or the multi-medicament dosage form, the end micropore that is used for the delivering drugs dosage form, the internal mechanism of isolation and release pharmaceutical dosage form, the internal electronics of the pharmaceutical dosage form quantity that control can be sent within cycle preset time (locking time), limit access to the security feature of the device of patient and/or one or more health care occupational staffs, reduce the security feature of the stolen probability of dispensing apparatus, allow dispensing apparatus to use the inquiry interface of historical information storage and that fetch, prevent that saliva from entering the device of described device, make the user activate the external switch of dispensing apparatus.Dispensing apparatus typically be hand-held and can carry out data communication by the mode of POP (" plugging into ").Can charge and carry out data access by the health care professional of authorizing dispensing apparatus with auxiliary in conjunction with fixing or portable connecting device.If user and patient identity do not mate, lockup period also finishes when providing trial, and perhaps sensor shows pharmaceutical dosage form not good (because of humidity, heat or expired), and then dispensing apparatus can be closed.In aspect of present embodiment, pharmaceutical dosage form and dispensing apparatus are designed to for example carry out the oral transmucosal drug delivery to the space, Sublingual.
In another embodiment, dispensing apparatus of the present invention comprises patient identity checkout gear, optical retina reader, speech recognition system, tooth identification system, image identification system or the DNA reader such as fingerprint reader.Dispensing apparatus can be to identify the user with one or more modes, makes mode that system can judge to authorize or unwarranted send the administration request.Guarantee that dispensing apparatus not by without permission individual accidental or wittingly use, to prevent accidental or the medicine of migrating wittingly, is important for effectively transmitting a lot of potential drugs and pharmaceutical dosage form.This patient's recognition system can be identified one or more users, and for example, in the hospital of inpatient arranged, dispensing apparatus can be programmed to identify the patient of appointment and the health care provider of mandate, such as nurse and doctor.Under for example arranging in out-patient family, dispensing apparatus can a patient to appointment respond.Dispensing apparatus can use any customer identification device, comprise fingerprint recognition, use the RFID of active or passive RFID label to detect, described label is placed on bracelet, necklace, clip, belt, band (strap), the viscosity adhesive plaster, graft, and use the RFID of the mode of location and adhered labels to detect, retina identification, DNA identification, speech recognition, password or code input, physical key, electronics or magnetic key, use human body or clothes as personal area network's identification of data or signal pipe line, optical scanning or facial recognition, sound wave, infrasonic wave or ultrasound wave are identified or are identified the individual or confirm any other device of its identity.
A kind of method of patient's identification is to use the passive RFID label of short distance (" near field "), described label is attached in bracelet, necklace, adhesive patches, label for clothing, the combination such as oral cavity erecting device, belt, band and these article of orthodontics frame, perhaps other position.When using the RFID label in " near field ", wherein " near field " roughly is defined as the about 16% of the wavelength of receiving signal, and label operates under the sensing mode of operation, magnetically coupling between reader and label antenna.There are two features in the near field: the firstth, and field intensity is along with the distance fast-descending, and the secondth, signal has very strong directivity.In the near field, signal intensity descends very fast, and the loss of signal strength is roughly per ten times apart from 60dB.In order to obtain the good sensing coupling between transmitter antenna and the RFID label antenna, two antenna directions are in parallel plane, and are and very approaching by the axis of each center of antenna.When installing very near the RFID label, provide strong signal intensity (healthy and strong patient identity).Simultaneously, when device during away from label, provide very weak signal, it helps to prevent the unauthorized use except other people of the patient who attempts to use this device.It is preferred making the antenna arrangement of making good use of in this near-field region.Further, for very short-range enough signal intensitys are used in correct identification, if so device is not in suitable direction and near the RFID label, it is very difficult receiving signal.In order to obtain short distance between antenna and correct direction, the antenna that dispensing apparatus can be designed to be installed in the RFID reader in the dispensing apparatus suitably is positioned near the RFID label antenna, described RFID label antenna is installed in for example wrist strap or bracelet, the perhaps clothing labels of collar is perhaps on hands, arm, buccal, neck or other locational viscosity adhesive plaster.Further, can make suitable arrangement and the location of RFID label antenna on wrist strap or the bracelet by prevent bracelet mode mobile in wrist or that rotate with little viscous adhesive cloth.
In another embodiment, dispensing apparatus arranges lower use high-frequency RF ID reader at inpatient (hospital, clinic etc.), described reader operates on 13.56 mhz band or near it, and the patient installs RFID label and the antenna of coupling at droppable bracelet or wrist strap, this design meeting is so that when removing bracelet or wrist strap, damaged or the breaking-up of other parts meeting of RFID label, antenna or interlock circuit, thus so that bracelet or wrist strap can't practical functions.In one example, the communication distance of RFID is shorter, preferably between 0 and 10 inch, more preferably between 0 inch and 5 inches, optimally between 0 and 3 inch, and can have directivity, so that the patient's of expection suitable use is comparatively easy and reliable, and make simultaneously other people's unwarranted use comparatively difficult, very difficult or impossible.
In another embodiment, the dispensing apparatus of the present invention that out-patient's (for example, in the family, office etc.) middle use is set comprises the electronic fingerprint sensor system and training identification patient's fingerprint when specifying or use for the first time.When the expection patient's self-administration the time, she can attempt identification with the identification of fingerprint sensor.In case dispensing apparatus successfully identification patient is the authorized user of device, dispensing apparatus carried out the single dose administration, and the effective a bit of time of release, such as 5 seconds.In case pharmaceutical dosage form is sent or 5 second time finished, dispensing apparatus can lock self effectively again, and needs another time fingerprint recognition before another time administration.
In another embodiment, dispensing apparatus of the present invention allows heart rate measurement, and until Heart Rate at preset range dispensing medicament.Dispensing apparatus can comprise any one for polytype a plurality of sensors of measuring inside and outside parameter, described parameter comprises biometric parameter, such as body temperature, breathing rate, blood pressure, hematochemistry feature, sialochemistry feature, breathing chemical feature, perhaps other biochemical states or can detect input, perhaps comprise external parameter, such as time, date, temperature, humidity, overall positions etc.
In another embodiment, dispensing apparatus of the present invention can have the dose counting feature, namely monitor and store drug use history, comprise the self-configuring dispensing apparatus is played the overall administration enumerator that all dosage of granting are counted, and reducible administration enumerator, described reducible administration enumerator can be resetted by for example nurse's mandate medical worker and follow the trail of reset from the last time the dosage of granting.Dispensing apparatus count enable of the present invention and demonstration medication amount to be provided that be issued and that keep.
In addition, in another embodiment, dispensing apparatus of the present invention can have storage device to keep the relevant in time information of delivering drugs dosage form.Storage device can comprise random access memory (RAM) and read only memory (ROM).CPU (CPU) for the treatment of information and various these function element of control device also is provided.
In another embodiment, the feature that makes things convenient for that provides in order to easy to use also can be provided dispensing apparatus of the present invention.But exemplaryly make things convenient for feature to comprise disposability, reusability, be convenient to recharging property, long-range wired or wireless activation, rechargeable battery and multi-medicament dosage form ability.
In another embodiment, dispensing apparatus of the present invention also can comprise the expired caution feature of the medicine that can prevent the expired medicine of unsuitable granting; The medicine outdated information; With as computer other the device exchange message interface; For medicine approaches control record date and the clock feature of time; And/or other is independent of the communication capacity of time.
In another embodiment, dispensing apparatus of the present invention provides the drug delivery device that can carry out controllable delivery, and described device is that electric monitoring and control make the patient can receive not only safety but also efficient dosage.
In another embodiment, dispensing apparatus of the present invention is the device of a kind of convenient operation, portable, self-powered, relatively economical, it allows to timely lock to avoid overmedicate, and prevent child with and prevent from distorting, and can realize the administration of many units, the natural law for the treatment of, all numbers or a month number can be recorded in the device like this.
In another embodiment, dispensing apparatus of the present invention can comprise the structural member of following functional connection: the medicine storage chamber, provide end, manual or electronic triggering trigger or button, one or more ports, internal electric source, user interface with the input and output function, microprocessor, wireless communication ability, patient and user identification (fingerprint reader for example, RFID) ability, prevent the saliva infiltration capability, interior humidity and dampness control, class Opium antagonist storage chamber, fill or other purposes access mouth, detect one or more sensors of inside and outside state, and biometric or fetcher code input.
In another embodiment, dispensing apparatus of the present invention can use one or more sensors to monitor various inputs in inside or the outside of dispensing apparatus.Some input can be the indication of built-in system state, and described built-in system state comprises that the position, the successful granting of tablet, unsuccessful tablet granting trial, tablet of tablet in the quantity, device of tablet in the device are positioned at the existence of specific position, tablet cartridge case, the identity of cartridge case, the position of drug administration mechanism, the temperature of installing or the sensing of humidity or any other internal configurations or state.Other input can be the indication of device external condition, comprises temperature, humidity, acceleration, light, perhaps near the user, other people, perhaps object, and other.Can be concrete for user or other people these inputs, and can comprise the interaction direct or indirect with device, switch, button, or the actuating of other input equipment or activation, body temperature, heart rate, breathing rate, blood pressure, hematochemistry feature, sialochemistry feature, breathing chemical feature, platycoria, perhaps any other biological aspect maybe can detect input.Described sensor can use the device of any detection input.A series of detected temperatures, humidity, acceleration, saliva enter or the input of other biometric can be used as a kind of the startup or the means of shutoff device under predetermined or condition able to programme.
In another embodiment, dispensing apparatus can by battery, electric capacity, fuel cell or other Power supplies, perhaps not need power supply, but need to manually boot.
In some embodiments, comprise can be by photoelectric cell charging or manual powered by crank or rocking arm for dispensing apparatus of the present invention.Rechargeable battery or other power supply can charge in the connecting device of charging cable or otherwise.
Figure 1A is the sketch map to a specific embodiment of the dispensing apparatus 10 of patient's delivering drugs dosage form.Dispensing apparatus 10 comprises pictorial displays 12, and the biometric patient identifies reader 13, and user interface 14 is provided button 16, and holds the housing 18 of providing cartridge case (dispensing cartridge).Dispensing apparatus 10 is configured to hold multiple dosage form.Pictorial displays 12 comprises liquid crystal display (LCD), and it can make dispensing apparatus 10 for example monitor and show administration frequency, patient information and/or progress msg.User interface 14 can be used for browsing and select to be presented at the menu item on the pictorial displays 12.Work as the user, for example the patient presses when providing button 16, can provide single dose.The patient of postoperative or other disabilities can not need just can operate with too much muscle power like this.It also allows to cure mainly nurse or doctor to patient's administration and monitors that their medication is historical.The dosage form of both can having provided granting button 16 on one's own initiative also can trigger logic switch and make the request of granting with the processor in the informing device.The patient identifies reader 13 (for example needs the identity input, fingerprint reader, optical retina reader, voice recognition, tooth recognition system, or DNA reader, RFID) or access code with prevent individual without permission chance or have a mind to migrating or abusing.
In an illustrative embodiments, dispensing apparatus 10 uses high-frequency RF ID reader under inpatient (hospital, clinic etc.) configuration, described reader operates on 13.56 mhz band or near it, and the patient is equipped with RFID label and the antenna of coupling at droppable bracelet or wrist strap, when in case this bracelet or wrist strap are designed to remove bracelet or wrist strap, other parts of RFID label, antenna or interlock circuit will be damaged or be damaged, thereby so that bracelet or wrist strap can't practical functions.In one example, the communication distance of RFID is shorter, preferably between 0 and 10 inch, more preferably between 0 inch and 5 inches, optimally between 0 and 3 inch, and can have directivity, so that the patient's who expects suitable use is comparatively easy and reliable, and simultaneously so that other people's without permission use is comparatively difficult, very difficult or impossible.
In another illustrative embodiments, being used for biometric patient that dispensing apparatus 10 that the out-patient arranges (such as family, office etc.) comprises, to identify reader 13 be electronic fingerprint sensor system and the fingerprint of training its identification patient when specifying or use for the first time.When patient's self-administration of expection, she can be at first attempt identification with fingerprint Identification sensor.In case dispensing apparatus 10 has successfully been identified the patient, the patient identify that 13 of readers can prevent by accident or wittingly with another patient's switch, and misapply by accident or by mistake dispensing apparatus 10.
Figure 1B is for the sketch map to the dispensing apparatus 10 of patient's delivering drugs dosage form.In this embodiment, dispensing apparatus 10 comprises the adapter of plugging into (docking connector) 20.The electrical connector 20 of plugging into can allow dispensing apparatus 10 be connected to other device, peripheral hardware or computer with to miscellaneous equipment, outside if computer is fetched, storage, swap data.
Fig. 1 C is for the sketch map to an example of the granting end 22 of the dispensing apparatus of patient's dispensing medicament dosage form.Described granting end is included in provides near reciprocal (shuttle) mechanism 24 of the granting of holding 26.
Fig. 1 D is the cross sectional representation to another embodiment of the dispensing apparatus 10 of patient's delivering drugs dosage form.This dispensing apparatus 10 comprises cartridge case (cartridge) assembly 30; One or more batteries 32; Processor and computer plate 34; Antenna 36; And antagonist storage chamber 38.Dispensing apparatus 10 can comprise reciprocator, such as reciprocator 24, with from medicine heap removing medication dosage form, provides end and can comprise slide mechanism, in order to provide single dose when pressing the granting button.
Dispensing apparatus of the present invention can comprise one or more following features: hand-holdable or portable; Comprise pictorial displays, interface button, scroll key and granting button; Comprise biometric fingerprint reader or other recognition device with identification and confirm that correct patient is using this device; Comprise the RFID reader; Comprise the pharmaceutical dosage form count feature; Comprise the storage device that keeps relevant medication historical information; Comprise for the interface that carries out bi-directional exchanges of information such as other device of computer; Be included in the LED, light, sound or the sense of touch indication that start when pharmaceutical dosage form is provided; Each dispatch hist one dosage form; Do not need to open and close lid or other hinge hole just can be provided dosage form; Comprise the antagonist storage chamber; Comprise the indicator of notifying the suitable medication of patient, perhaps be included in the indicator of making prompting in the situation that has potential danger or non-effective medication, again or comprise the indicator that the notice Patient's surplus time finishes to lock-up cycle.
In some embodiments, dispensing apparatus of the present invention has the outward appearance (shown such as Figure 1A) of tube for transfusion, and therefore the child is lacked captivation (opposite with the ACTIQ lozenge with lollipop outward appearance).
In other embodiments, described dispensing apparatus can be suitable for being connected to cotton rope, so that dispensing apparatus is suspended on patient's the neck or such as adhering on one's sick bed.This can in the configuration of hospital for example, help anti-locking apparatus misplace or install stolen.This dispensing apparatus can comprise that also clasp is can be attached on clothes or the hospital bed.
Dispensing apparatus can adopt one or more anti-theft devices to prevent or to stop device or pharmaceutical dosage form unwarranted stolen or distort.This anti-theft device is used in hospital, clinic or the health care configuration is lower, and in the family, office or described dispensing apparatus tendency or be not inclined to the resident or place that plays a role anti-locking apparatus stolen or distort temporarily or for good and all.Exemplary anti-theft device comprises that physics lockset, rope, cable, clip or other forever or temporarily are connected to other physical connection thing on another object or person body.
The illustrative embodiments of physics anti-theft device is the elasticity cable, and the one end is locked on the dispensing apparatus, and the other end then is locked on the sick bed of hospital with fake, retaining mechanism or other junctional complex.In this embodiment, the release from dispensing apparatus or from the hospital bed of cable rope can move the patient maybe can to abandon or with key, password or other can be controlled the multiplexing described device of mode of approaching retaining mechanism.
Antitheft mode can comprise alarm or the notice that can trigger the caution on dispensing apparatus, connecting device or other peripheral hardware; On the computer or alarm or notice by wired or wireless network, perhaps can warn other remote equipment.Alarm or notice can be audition, sense of touch or visual alarm or notice, perhaps can adopt the alternate manner of notifying one or more individualities.In one embodiment, this alarm or notice can represent that dispensing apparatus is stolen or be in the stolen process.Except alarm, the information of relevant thievery can to or the slave unit transmission, comprise time, date, voice data, video data, GPS or other positional information, perhaps help to prevent or distort any out of Memory of dispensing apparatus or tablet wherein.These anti-theft devices can comprise the activation of dispensing apparatus feature, comprising large alarm song, shock by electricity, close or the granting of one or more aspects, ink or other sign of breaking plant or make the unavailable or undesirable action of internal drug.Dispensing apparatus of the present invention can use one or more measures to stop theft or to distort.
Disposing lower situation of sending the Sublingual sleeping pill with inpatient (for example, hospital or clinic etc.) is the illustrative embodiments that example illustrates this deterrence measure.In this case, dispensing apparatus comprises that wireless proximity detects, and when RFID or be used for the detector of wireless network for example detect the predetermined dispensing apparatus of closely removing from personnel, object or physical location.When detect dispensing apparatus from the precalculated position or near when removing, dispensing apparatus can be closed normal function, the alarm of sounding, send wireless caution information to remote-control device or network, and trigger inner releasing liquid to the tablet cartridge case with all tablets of moistening and/or reduce the activity of all tablets, thereby make them ineffective.
In another illustrative embodiments, dispensing apparatus of the present invention is in order to sending the Sublingual pharmaceutical dosage form of sleeping peacefully under out-patient (in such as family, office etc.) configuration, when internal sensor or switch can detect in situation without permission or unintentionally that dispensing apparatus is opened, dismantled, damage or power down.The detection of this event can cause the internal microprocessor recording events, and triggers the inside release such as the liquid sleeping pill antagonist of naloxone in the situation that system can accomplish, like this with all tablets of moistening, makes them lose the effect of sleeping pill and sublingual tablet.
In an illustrative embodiments, dispensing apparatus is handheld type devices, comprises the control interface and comprises the dispensing apparatus end at the other end at the one end.The control interface comprises the feature of some, from the LCD monitor screen (for example, pictorial displays 12 shown in Figure 1A), to the speaker that user feedback is used, various interfaces and/or scroll key (for example, the user interface shown in Figure 1A 14), (for example provide button, and biometric fingerprint reader (for example, the biometric patient shown in Figure 1A identifies reader 13) granting button 16 shown in Figure 1A).Provide end and can comprise slide mechanism (for example, user interface 14 as shown in Figure 1), provide single dose when pressing the granting button with box lunch.
Described dispensing apparatus can use the interface of one or more levels to use for dissimilar authorized users, for example patient, nurse, doctor, pharmacists or other medical treatment or health worker.The element that these different interfaces comprise has keyboard, button, graphic icons and instruction, light, LED, monochrome or color graphics or indicator by character, touch screen, LCD, sound, tactile feedback, speech recognition interface and other input and output devices and device.The activity of user interface or pattern can be determined by the operator scheme of dispensing apparatus, by user's login or access activity such as input password or code, by connecting from connecting device, computer or the Internet or disconnecting or detection granted access key, for example key and/or RFID label, or similarly combination.After changing interface modes, the functional of described device is changed, thereby activates, stops or changing the functional of above-mentioned various excuse elements.By allowing device to have one or more interface models, and change relevant with each pattern functionally, then can make described installation optimization for various uses.
In an illustrative embodiments, dispensing apparatus of the present invention is used for providing sublingual tablet in inpatient (hospital, clinic etc.) configuration.This device comprises that microprocessor, storage device, LCD literal and pictorial displays, band are useful on the keyboard of some buttons of browse graph shape menu and selection function, and the drug administration mechanism that is used for providing sublingual tablet.
Fig. 2 is for the sketch map at the cartridge assembly 40 of dispensing apparatus delivering drugs dosage form.Cartridge assembly 40 comprises lid 42, spring 44, piston 46, dosage form 48 and cartridge case pipe 50.During assembling, dosage form 48 is put into cartridge case pipe 50, the piston 46 of then packing into, spring 44 and lid 42.In case this assembled is complete, then this assembly is inserted dispensing apparatus, for example dispensing apparatus 10.
Fig. 3 A and 3B show the single dose applicator for the dispensing apparatus of delivering drugs dosage form.Dispensing apparatus shown in Fig. 3 A has described to prepare the single dose applicator 48 of dispensing medicament dosage form 48.In aspect of this embodiment, the user pinches the single dose applicator, opens like this applicator and dispensing medicament dosage form 48 as Fig. 3 B illustrates.
But pharmaceutical dosage form sending trap dispensing medicament dosage form of the present invention or can provide and be attached to or be contained in the droppable applicator is to allow described dosage form manual application in the precalculated position of drug delivery (for example, oral cavity, space, Sublingual, eyes etc.).In one embodiment, the single dose applicator can be used for various pharmaceutical dosage forms, comprises solid tablet, liquid capsule, gel capsule, liquid, gel, powder, thin film, bar, band, spraying (spray), mist agent (mist), paster or any pharmaceutical dosage form that other is fit to.Single dose applicator (SDA) can be held dosage form, can make pharmaceutical dosage form attached or attached to it, can provide to seal to prevent dampness, humidity and light, and can manually handle in drug delivery, pharmaceutical dosage form to be placed on the appropriate location by patient, health-care hospital ISP or other user.The form of SDA can be tweezers, syringe, rod or bar, suction pipe, dropper or aerosol apparatus or any form that is fit to use the single medicine dosage form.After the use, described SDA can be abandoned, to eliminate the risk of saliva or other contaminants sending trap.
In another embodiment, sending trap of the present invention can hold some SDA in cartridge case or with the form of independent encapsulation, can provide to comprise that the single SDA that holds the single medicine dosage form is for patient, health-care hospital ISP or user.Described sending trap can be provided single SDA in an identical manner, and has such as the advantage of the single pharmaceutical dosage form of granting described in the invention.
Fig. 3 A has described the illustrative embodiments of SDA of the present invention.Shown in Fig. 3 B, when sending and it is pushed, deformation partly occurs in flexible hinge, and dosage form is discharged in the space, Sublingual at the position application device.After providing dosage form, can abandon this sending trap.
Dispensing apparatus can use the interface of one or more levels to use for dissimilar authorized users, for example patient, nurse, doctor, pharmacists or other medical treatment or health worker.The element that these different interfaces can comprise has keyboard, button, graphic icons and instruction, light, LED, monochrome or color graphics or indicator by character, touch screen, LCD, sound, tactile feedback, speech recognition interface and other input and output devices and device.The activity of user interface or pattern can be by operator scheme the determining as inputting the login of password or code or access activity with the user of dispensing apparatus, by connecting from connecting device, computer or the Internet or disconnecting or detection granted access key, for example key and/or RFID label, or similarly measure.After changing interface modes, the functional of described device is changed, thereby activates, stops or changing the functional of above-mentioned various interface element.By allowing device to have one or more interface models, and change relevant with each pattern functionally, described device is optimized.
An illustrative embodiments that is used for the dispensing apparatus of inpatient (hospital, clinic etc.) comprises that microprocessor, storage device, LCD literal and pictorial displays, band are useful on the keyboard of some buttons of browse graph shape menu and selection function, and the drug administration mechanism that is used for providing sublingual tablet.In this embodiment, dispensing apparatus will have two kinds of interface models: patient's pattern and healthcare givers's pattern, for example, nurse's pattern.Under patient's pattern, only have the work of the button of granting, and demonstration and keyboard right and wrong are functional.Under healthcare givers's pattern, show and keyboard is functional, and the nurse can access medication history dose intensity, patient ID, the residue dosage in the equipment, and any out of Memory of accessing for the nurse of having of dispensing apparatus.The nurse can have the RFID label, and dispensing apparatus is healthcare givers's access tag with this tag recognition, when label exists, switches to healthcare givers's interface model, when label does not exist, switches back the patient interface pattern.
In another illustrative embodiments, dispensing apparatus of the present invention is used for the sublingual tablet granting under inpatient (hospital, the clinic etc.) configuration.Dispensing apparatus comprises microprocessor, storage device, Multicolor LED lamp, is used for providing the granting button of sublingual tablet, and connecting device adapter or wireless connecting device.In addition, also have the portable hand-held connecting device, it comprises microprocessor, storage device, figure and indicator by character, keyboard and connecting device adapter or wireless connecting device.When dispensing apparatus is used for patient's pattern, because it is regular that dispensing apparatus is in time lock, therefore when allowing patient's medication, LED shows a kind of color, and is for example green, and when not allowing patient's administration, it can show another kind of color, and is for example amber, and when dispensing apparatus lost efficacy, then show the third color, for example red.When LED showed green, the patient can provide sublingual tablet voluntarily.Under a kind of occasion, nurse or other authorized healthcare givers can bring portable connecting device into ward, and with physics or the wireless mode dispensing apparatus of plugging into healthcare givers's interface model can be operated.Under healthcare givers's interface model, the nurse can browse medication history, dose intensity, and patient ID remains dosage in the equipment, and any out of Memory for nurse access that has of dispensing apparatus.Further, administration enumerator, the inquiry error condition of nurse on can reconfiguring equipment, provide bolus etc. when needing.When portable connecting device disconnected from dispensing apparatus, dispensing apparatus can return the patient interface pattern.
In another illustrative embodiments, dispensing apparatus of the present invention is used for the sublingual tablet granting under out-patient (family, the office etc.) configuration.Dispensing apparatus comprises microprocessor, storage device, is used for providing granting button, small size electrical loudspeaker and connecting device adapter or the wireless connecting device of sublingual tablet.In addition, also can comprise static POP, it will hold microprocessor, storage device, plug into adapter or wireless connecting device and with the device of telephone wire, computer or network connection.In patient's mode of administration, when the needs administration, the patient presses the granting button.If the regular troubles person of the time lock between administration presses the granting button, sound can sound, and he must wait for before administration again to notify the patient, and dispensing apparatus can not provided tablet.If after the time lock between the administration regularly finished, the patient pressed the granting button, then dispensing apparatus can be provided tablet and confirm that sound can sound, and notifies patient's pharmaceutical dosage form to provide.When dispensing apparatus is docked with on the static connecting device in physics or wireless mode, dispensing apparatus will with connecting device or other is connected to doctor's computer or the communication mode on other device exchanges with patient's doctor, exchange message, and allow the doctor to browse enumerator on patient's the history, download message, replacement dispensing apparatus, make any further feature effective or invalid in long-range mode.When taking off dispensing apparatus from connecting device, dispensing apparatus can return the patient interface pattern, until the doctor indicates dispensing apparatus to carry out other operation.
Dispensing apparatus of the present invention tablet or other dosage form can be sent in one's hands in, in the oral cavity, Sublingual or other be suitable for the position that specific medication is sent demand.In one embodiment, in the delivery system of Sublingual, dispensing apparatus is delivered to solid tablet in the space, Sublingual in oral cavity.In this embodiment, the solid dosage forms in the dispensing apparatus should keep dry before granting, when single tablet enters the space, Sublingual from the dispensing apparatus granting of drying, at this moment patient's saliva can the moistening tablet and device put the medicine end.Need a kind of device to prevent that saliva from entering dispensing apparatus and moistening tablet, perhaps isolate any saliva and enter dispensing apparatus, thereby tablet is wherein kept dry, and perhaps absorption or absorption enter any saliva of dispensing apparatus so that tablet keeps dry perhaps any combination of these methods.
Prevent that the device that saliva or other dampness enter dispensing apparatus from can comprise, but be not limited to the sealing member of one or more elasticity or rigidity, one or more elasticity or rigidity wiper, one or more absorbing material elements, manually or the automatically door of switch or lock, positive air pressure and air-flow are perhaps in the tablet delivery port with the gap between the mucosal tissue in the oral cavity of saliva or predetermined distance.
Fig. 4 A is sketch map for the exemplary dispensing apparatus 58 of delivering drugs dosage form 48 to 4D, wherein, provides and make the minimum device of saliva that flows into dispensing apparatus 58 in process from dosage form 48 to the patient that provide.Dispensing apparatus 58 comprises impeller/sliding part 60, housing 62, promotes guide groove 68 and spring 72 in tooth bar 64 and the housing.Fig. 4 A has illustrated as the multistage of the pharmaceutical dosage form 48 that reduces the mode that saliva enters dispensing apparatus 58 to 4D and has provided.In Fig. 4 A, impeller/sliding part 60 is ready to promote to be contained in tooth bar 64 and the gear 66 in the housing 62 of device 58.Guide groove 68 provides the space that moves freely in guide groove 68 for impeller 60.Pharmaceutical dosage form 48 is positioned at the top of tooth bar 64 and spring 72 to be provided and has moved and returned tooth bar 64 necessary tension force and mechanisms.In the dispensing apparatus 58 shown in Fig. 4 B, impeller/sliding part 60 is promoting to be contained in tooth bar 64 and the gear 66 in the housing 62 of device 58.Pharmaceutical dosage form 48 is pushed upwardly in guide groove 68 by the power that the spring 72 on the tooth bar 64 provides.In the dispensing apparatus 58 shown in Fig. 4 C, pharmaceutical dosage form is issued and gives for example human object from the end of guide groove 68.So, shown in Fig. 4 D, repeat above step with continuous dispensing medicament dosage form 48, and make the saliva in the access to plant 58 minimum.Can be in the following manner to enter the saliva of dispensing apparatus 58 minimum: when design apparatus, use sealing member, wiper, absorbent, desiccant, pop-up type device, air gap or above combination, perhaps so that minimum any other device of the saliva that enters.A kind of device that allows saliva to enter dispensing apparatus comprises inside wiper or the sealing member of one or more elastic or rigidity, medicament storage box comprising the pharmaceutical dosage form of some independent encapsulation or isolation, the passage of sending from cartridge case to outlet, described passage is tortuous or multistage, and saliva or dampness can't be along sending the passage resorption like this.
Fig. 5 and 6 is sketch maps of providing the exemplary shape of end, wherein shows two kinds of devices that keep the sealing member drying.Fig. 5 shows an example of dispensing apparatus granting end shape 80, and Fig. 6 shows another example of providing the end shape.
In one embodiment, the invention provides dispensing apparatus from multiple agent type to the zone, Sublingual that provide, ought provide simultaneously like this lock-in feature regularly to prevent by accident excessively administration.Dosage and corresponding locking time can be according to the size of medication object and the therapeutic goal adjustment of expection.
The device that the present invention relates to or dispensing apparatus can comprise and timely lock feature, wherein said device comprises that described lockout interval is selected from for the device of setting lockout interval between administration: regular time interval, predetermined time interval, predetermined variable time interval, the interval of being determined by algorithm and from remote computer or POP and send the variable time interval of described device to.
Described dispensing apparatus can comprise with lock-in feature dangerous or the unschedulea mode dispensing medicament.This lock-in feature is by locking mechanism or the part in the mechanism is broken away from, or controls drug administration mechanism in the mode of microprocessor and algorithm in lockup period, mechanically prevents described device administration.Locking can be fixing during (for example 10 minutes) locking, predetermined changeable duration locking, " intelligence " changeable duration or lock based on " triggerings " of inside or external event or state.Fixing locking meeting is providing after each administration between fixing lockup period, and wherein said device will not allow to send follow-up dosage.Predetermined variable latching is providing according to predetermined table locking time (for example, increasing by a minute behind each successive administration between lockup period) after each administration between variable lockup period.The data or the input that consider that medication is historical, medication request or algorithm can be used for making a strategic decision, " intelligence " locking meeting provides between variable lockup period based on internal algorithm.For example, intelligent locking can be considered the pharmacokinetic properties of specific medication molecule, and how human body is naturally removed along with the time or changed medicine.The locking that triggers can respond inside or outside triggering, such as from the data (for example temperature, humidity, heart rate, breathing rate, blood pressure) of sensor, internal signal (date, time or from the position of GPS), from the signal of outer computer, network or other electronic installation, physics, magnetic or electron key, such as the reception of machinery or the electronic access signal of password, code, RFID signal or other wired or wireless signal.Dispensing apparatus of the present invention can use one or more lockings described here.
In an illustrative embodiments, described dispensing apparatus comprises intelligent locking, and described intelligent locking prevents from providing tablet based on medication history and internal algorithm in the certain hour after initial administration.In this embodiment, behind the pharmacokinetic properties of the medication history of knowing the patient and medicine, calculate locking time to predict safe medication interval.
In another illustrative embodiments, dispensing apparatus is by programming to allow the convalescent administrations in 72 hours after the outpatient service plastic surgery operations of a small size.When described device at first was assigned to the patient, the internal clocking in the described device began to record the time that passes.When the time that passes reaches 72 hours, described device locking (lock down), and notify patient's dispensing apparatus to expire and no longer allow delivering drugs.
Fig. 7 A is the sketch map of an embodiment that comprises the drug administration mechanism 84 of lockout feature to 7D.Drug administration mechanism 84 comprises push rod 86, latch fitting 88, button/thrust piece 90 and wedge 92.In use, button/thrust piece 90 is pushed latch fitting 88 to push rod 86.When latch fitting 88 was lifted, button/thrust piece 90 can't promote latch fitting and described mechanism is locked.Fig. 7 A has illustrated the stages of the locking mechanism relevant with the dispensing medicament dosage form to 7D.Fig. 7 A shows predetermined lockup period, and also end, drug administration mechanism 84 still are in latched position, the situation that while latch fitting 88 is lifted.In Fig. 7 B, predetermined lockup period has finished and latch fitting 88 is in low level and locking mechanism allows drug administration mechanism to be in issuance location.Fig. 7 C shows next step, and namely drug administration mechanism 84 operates, and button/thrust piece 90 is pushed latch fitting 88 to push rod 86 with dispensing medicament dosage form (not shown).Fig. 7 D shows the latched position into the predetermined lockup period of providing next time.Described locking device can be installed in the dispensing apparatus to prevent unwarranted medicine granting.Whether the exit can place sensor and successfully provide to detect dosage form, and carries out internal record by connecting device or the computer of dispensing apparatus or wired or wireless connection.Locking device can comprise: push rod movably; Irrevocable formula push rod; The electro-mechanical adjustor; Optical pickocff pair; The magnetic hysteresis shaft coupling; Locking on the actuator; The rack-and-pinion device; The safety switch chain shot; Electromagnetic valve; Collet chuck on the axle; Axle with keyway; Shaft coupling movably; Cam.
In another illustrative embodiments, described dispensing apparatus is programmed to allow the convalescent administrations in 72 hours after the outpatient service plastic surgery operations of a small size.When described device at first was assigned to the patient, the internal clocking in the described device began to record the time that passes.Reach 72 hours when the time that passes, described device locking, and notify patient's dispensing apparatus to expire and no longer allow delivering drugs.
The present invention has provides a kind of predose and device of subsequent dose and locking time adjusted.Behind assessment blood drug level, can assess to determine suitable administration time table and locking time to the patient.
Described dispensing apparatus allows to adopt show variable, predetermined locking time, described timetable can change along with the progress of length, the time of every day, disease or the symptom of writing out a prescription, and can be based on prescription, medicine, medication historical and as important vital sign (for example, breathing rate or the blood pressure of being determined by the non-intruding mode) other patient's specifying informations, use algorithm and determine harmony in the exterior cycle locking time with activating agent.
If the patient obtains fully treatment benefit from single administration, be can be to patient's rechallenge with the advantage of the repeatedly medication feature of locking, and with its blood drug level of mode titrimetry of safety.This process can be repeated until the acquisition effective blood drug concentration.
The predose of dispensing apparatus of the present invention and locking time be when beginning treatment according to age of patient and body weight and the historical configuration for the treatment of.But predose and locking time can be adjusted subsequently according to reaction, treatment cycle etc.
The initial timing lockup period of dispensing apparatus of the present invention from 3 minutes to 40 minutes or from 5 minutes to 30 minutes, is configured in one minute interval of from 1 to 60 minute typically from about 1 minute to about 60 minutes in special situation, for example, and 5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59 or 60 minutes.
The invention provides the dispensing apparatus with programmable lock-in feature, described lock-in feature is used for locking described dispensing apparatus when the device locking.This prevents or stops abuse or accidental or unintentionally misuse.Lock-in feature is moved in the mode of selecting from the group that is made of following manner: removable push rod; Irrevocable push rod; The electro-mechanical adjustor; Optical pickocff pair; The magnetic hysteresis shaft coupling; Locking in the brake; The rack-and-pinion device; The safety switch lock; Electromagnetic valve; Collet chuck on the axle; Axle with keyway; Removable shaft coupling; Cam.
The invention provides a kind of dispensing apparatus with access control apparatus, in order to the personnel of control except the health professional abuse or accidental or misapply unintentionally.If cartridge case is not loaded, locks and started by the health professional, then this dispensing apparatus can not play a role.
Dispensing apparatus of the present invention can repeatedly use or abandon, like this when all can abandon it when originally the medicine of charging apparatus has been issued.
The present invention further contemplates that and uses dispensing apparatus of the present invention to send the dosage form of small size that described dosage form is solid, liquid, suspension, thin film, gel, spray, mist agent, foam, arrowband, paster or paste.Correspondingly, dispensing apparatus provided by the invention can provide predetermined delay in the mode of liquid or gel dispensing apparatus between dosage.Described mechanism comprises liquid or gel storage chamber and leads to the thin outlet of the second cylinder chamber by storage chamber that described storage chamber is by for example pushing ram or the slight pressurization of spring-loaded piston.Cylinder chamber can comprise the granting piston that is connected to rod member, and the granting end more much bigger than the thin outlet that is connected to storage chamber.Provide end and can comprise the valve member that prevents from being not intended to dispensing medicament.Can design the viscosity, the pressure in the storage chamber of pharmaceutical preparation and the size of thin outlet, thereby so that the pharmaceutical preparation of viscosity flow to the cylinder chamber lentamente from the pressure storage chamber, and backward pushing piston until described cylinder chamber be filled.This process need regular hour, the described time can pre-determine and with drug dose between suitable locking time cooperate.When cylinder chamber is filled, provides valve member and can prevent the medicine leakage.Depress rod member with from the cylinder dispensing medicament.The brake function of rod member is also opened and is provided valve member to allow to provide liquid or gel.In one approach, provide end and be far longer than outlet, medicine preferentially is pushed out and provides end like this.It is possible using this system's dispensing medicament before cylinder chamber is full of fully.If fill cylinder chamber with constant speed, then medicine granting amount is proportional with the time of filling cylinder chamber, until cylinder chamber is full of fully.Therefore, if dispensing apparatus starts prematurely, then dispensing apparatus will only be provided the part of liquid or gel.
In one embodiment, the device that produces audio frequency, video or haptic signal when dispensing apparatus of the present invention is included in dispensing medicament is to provide feedback to the patient, and namely medicine has been provided complete.In the small size dosage form, throw in such as the Sublingual
Example in, therefore the patient may not know that medicine is arranged in its Sublingual cavity, needs another kind of feedback system.The invention provides this purpose scheme of realization.
Dispensing apparatus of the present invention can be with the number of colors manufacturing relevant with medicament categories so that identification drug dose easily.This device can have other dosage visual, sound or the tactile recognition device wherein holds with reception and registration.
Dispensing apparatus of the present invention provides mechanical protection for the dosage form of wherein holding, and can prevent fracture, cracked and hydration.This point is even more important for little fragility frangible dosage forms.Described dispensing apparatus can be suitable or predetermined direction and repeatably mode anisotropy or dosage form heterogeneous are placed on the Sublingual.
Dispensing apparatus of the present invention can be used for providing one or more medicines, and described dispensing apparatus provides some dispensing apparatus in some embodiments, and described dispensing apparatus comprises more than one medicine, medicament, pharmaceutical dosage form etc.In a similar fashion, dispensing apparatus can hold multiple dosage form in a plurality of cartridge cases, and described dosage form is provided with multi mechanism and the mode of sending passage etc.
Dispensing apparatus of the present invention comprises that the user (for example doctor, nurse, doctor or other healthcare givers) who allows through ratifying or authorize carries out recharging of pharmaceutical dosage form, and refuses unauthorized individual's access.
In other embodiments, dispensing apparatus of the present invention comprises the end abandoned in contact patient body or oral cavity, thereby so that a plurality of patient can use this dispensing apparatus in without the situation of cross contamination risk.
In another embodiment, dispensing apparatus of the present invention comprise the microprocessor of communicating by letter with display device with storage device so that described dispensing apparatus can the monitoring and controlling administration, administration frequency and plan, and to the access of program and the historical information of medicine and storage.
In another embodiment, adjust dispensing apparatus can follow the tracks of with informing device in the total quantity of the medicine preserved to preset and plan recharges.Described dispensing apparatus also can the recording and tracking medicine use, and plug into by wireless protocols or by electronics alternatively and transmit this information to monitor patient's drug use to health care provider.
In some embodiments, can remotely manage so that the doctor supervises with care the dispensing apparatus programming.It can comprise RF identification (RFID) system, WiFi communication or other remote operating system, to communicate by letter with dispensing apparatus and to control dispensing apparatus, in order to use history, residual drug, cell water equality to carry out remote monitoring to error code, administration history, patient.This system can comprise unique key of each device usefulness, and described key must could be worked by approaching device, can prevent like this special use accidental or that have a mind to, and abuse or unauthorized persons are near medicine.This remote operating system also can provide the special key that is positioned at patient's bedside, described key may be placed on the support or in the connecting device, or be attached to the patient with it or on the his or her clothes, also can be at bracelet, necklace, viscosity adhesive plaster, or on the clip, with avoid between the patient device exchange accidental or that have a mind to or other chance or migrating of having a mind to.
In certain embodiment, dispensing apparatus of the present invention be used for to be provided for example opioid controlled substance, and dispensing apparatus can be designed to prevent that the configuration of having a mind to migrate from holding class Opium antagonist.Dispensing apparatus can be equipped with small volumes of liquids Opiate antagonist storage chamber, and described storage chamber keeps less pressure, and tilts antagonist is poured into the dosage form cartridge case.Electricity applying system prevents on one's own initiative that by valve body or other controlled pipeline the antagonist storage chamber is full of cartridge case.When the migrating of power down, important physical damage or malice occurring, the antagonist storage chamber can be issued to the sleeping pill antagonist in the cartridge case, makes dosage form be not suitable for using.In this embodiment, when occurring powering up or thrashing, device damage or when distorting event, dispensing apparatus mixes with pharmaceutical preparation with for example liquid form in independent storage chamber.
In some embodiments, replace antagonist with disrupting agent (spoiling agent).If dispensing apparatus is forced to open, then disrupting agent will contact and pollute pharmaceutical preparation, make it can't be fit to any unauthorized use.
In order to prevent that pharmaceutical dosage form is exposed in the dampness from humidity, saliva, perhaps accidental being exposed in other water fluid, dispensing apparatus and the container or the cartridge case that hold pharmaceutical dosage form in dispensing apparatus can hold desiccant.Prevent that the mechanism that saliva enters from comprising desiccant, sealing member, wiper, absorbent, absorbent wiper and sensor.Desiccant is the sorbate of solid, liquid or gel form, and described sorbate has hydrophilic, and absorb or absorption from the dampness of surrounding, thereby the dampness in the control current environment.Can use commercial desiccant when enforcement is of the present invention, comprising injection-molded plastic, the form that commercial desiccant is taked usually has bead, little cylinder, parcel, capsule, powder, solid material, paper, plate, fritter, adhesive patches and thin film.Exist and to be permitted eurypalynous solid drier, comprise silica gel (sodium silicate, solid but not gel), aluminosilicate, activated alumina, artificial silicate, molecular sieve, illiteracy unsticking soil, calcium oxide and calcium sulfate, any form is all in the present invention available.Different desiccant has different affinitys and different absorbing power, absorbance or adhesive rates to dampness or other material.Simultaneously, all can reach balance under the different relative humiditys of dissimilar desiccant in its surrounding.Be subject to the means of influence of moisture as the inside that prevents dosage form and dispensing apparatus of the present invention, one or more desiccant can be applied in the dosage form (for example tablet) or near in the granting end of dosage form, the dosage form or near dosage form send in the passage, in tablet container or the cartridge case, form in other elements of dispensing apparatus of casting element of dispensing apparatus or near these other elements or dispensing apparatus is inner or outside any other position.
Droppable and reusable dispensing apparatus of the present invention
Use when the expection of dispensing apparatus of the present invention and to finish, and when no longer needing dispensing apparatus, can abandon fully, part is abandoned and part reusable or complete this device of reusable.In an exemplary application, can use dispensing apparatus that sublingual tablet is placed on patient's Sublingual, and provide a kind of device to provide voluntarily another sublingual tablet until the safety lock between the administration regularly finishes, a kind of device and a kind of device that this historical information is passed to user, computer, another electronic installation or network in order to recording medicine history to forbid the patient.
Because the value of the many elements in the dispensing apparatus of the present invention is higher, and provides end and may produce infectious disease danger, provide end and multiplexingly comprise that the end of microprocessor, storage device, battery etc. is favourable so abandon.The sending trap of reusable dispensing apparatus needs the rechargeable source, rechargeable battery for example, replaceable battery, but refilling fuel battery, or the device of other replenishment system power supply.Dispensing apparatus can comprise following any combination: can abandon fully or reusable granting end parts, fully can abandon or reusable cartridge case part, fully can abandon or reusable head part, can abandon fully or reusable granting end and head combination, be used for fixing or portable connecting device, charging station, the diagnostic terminal of access and transfer of data and encrypt assembling and disassemble the station.
In an illustrative embodiments, comprise droppable granting end, droppable cartridge case section and reusable head for the dispensing apparatus of inpatient (hospital, clinic etc.).Droppable granting end comprises delivery end, drug administration mechanism, connects and locks onto the device of reusable head, and prevents that saliva from entering and surpass the device of providing end.Droppable cartridge case can hold a plurality of pharmaceutical dosage forms, insertion reusable head maybe can be abandoned the device of end and the device of arranging and hold pharmaceutical dosage form.The reusable head holds the device of microprocessor, storage device, the power supply such as battery, the user interface that comprises button, keyboard, display and LED etc., charging between using and allows the device of droppable cartridge case insertion head, adheres to and lock onto the device that can abandon end.At configuration phase, work as authorized user, such as the nurse, when preparing dispensing apparatus for the patient, the nurse can open the granting end of new encapsulation, obtains new medicine from hospital's medicine delivery system and fills cartridge case, and obtain the reusable head of charging from charging.The nurse can insert cartridge case reusable head or droppable granting end, and with the assembling of droppable granting end and lock onto the reusable head, so droppable cartridge case is contained in the device of having assembled.Then how the nurse can use this device and this device is issued the patient with automedication to patient's demonstration.In unloading process, when the patient used dispensing apparatus to finish its treatment, the nurse can pull down the reusable head from abandoning main body, thereby exposes cartridge case (container) wherein.The nurse can abandon cartridge case and any remaining medicine according to hospital's agreement, droppable granting end is discarded in sharp instrument or the biohazard container, wipe away paper wiping reusable head with sterilization, then described head is placed on the charging station battery charging and in the future multiplexing.
The invention provides the dispensing apparatus with single drug administration mechanism, described drug administration mechanism comprises reusable single dose applicator.Individually dosed mechanism can comprise: reusable single dose applicator; The paillon foil bubble; Rotate the station; Dish, stripping band device (ribbon peeler) with ejector; Band pick-up (ribbon picker); Dish type separator (disk singulators); Flexible disc; Arc or spiral type single dose applicator; Putter type medicine heap ejector; And rotate medicine and pile ejector.
The ability that dispensing apparatus is identified specific cartridge case can comprise (for example bar code) machinery, optics, electronics (for example microchip), magnetic, radio frequency, other device chemistry or the detection and Identification cartridge case.In an exemplary embodiment of the present invention, cartridge case can hold the physical button details on the cartridge case, and described details is detected with physics mode by the sensor in the dispensing apparatus or switch or a series of sensor or switch.When packing cartridge case into dispensing apparatus, sensor or switch array can read the machinery code and identify cartridge case and content and/or out of Memory.
In another illustrative embodiments, cartridge case is equipped with the microchip reader with electronic microchip manufacturing and the dispensing apparatus of uniqueness, in the time of like this in dispensing apparatus that cartridge case is packed into, dispensing apparatus reads the information on the microchip and identifies cartridge case and content and/or out of Memory.
In some embodiments, can reequip cartridge case, in the trial and success of dispensing apparatus that cartridge case is packed into or when unsuccessful, the information that dispensing apparatus has been loaded cartridge case or has attempted load cartridge passes to cartridge case like this.This system can comprise with other device physics, electronics, optics, magnetic, chemistry or the information of record from the dispensing apparatus to the cartridge case.
In case dispensing apparatus has identified cartridge case, or attempted identifying cartridge case, then dispensing apparatus can change or stops that it is functional based on this information.For example, if detecting and recognize, described device holds the Sublingual class Opium dosage form that possesses certain strength and Post-operation Pain Relief cycle, dispensing apparatus can be formulated specific Lock-Up Agreement between the dosage, specific patient's identification protocol, administration historical record agreement, and it can suitably change the user interface between itself and other object.
Further, if inner or outside near medicine then can revise identity or cipher feature on the cartridge case at described dispensing apparatus, described like this dispensing apparatus can identify before cartridge case is packed described dispensing apparatus into and just be opened.By this way, whether dispensing apparatus can detect the cartridge case that has loaded and be tampered or once used.
The functional aspect of dispensing apparatus of the present invention
Fig. 8 A is the sketch map of exemplary drug administration mechanism, and described mechanism is used for sending the dispensing apparatus 100 of small-volume oral transmucosal pharmaceutical dosage form, and wherein the cylindricality drug administration mechanism is in resting position.Drug administration mechanism comprises one or more cartridge cases 102, start button 104, motor 106, cam disc 108, desiccant 110, one or more sealing member 112, sends sensor 114, alligator clamp 116 and spring 118.Dispensing apparatus 100 of the present invention provides the granting of dosage form, an end of described cartridge case or medicine box to have spring 120 so that the dosage form heap is applied holding power based on a pile that is contained in cast cartridge case or medicine box 102 or some dosage forms 48.Fig. 8 B is the sketch map of dispensing apparatus among Fig. 8 A, and wherein drug administration mechanism, motor and cam disc are in resting position.Assembly 102 and dosage form heap are positioned on the sliding part 124, and described sliding part moves perpendicular to the axis of pharmaceutical dosage form heap 48.Sliding part 124 is thin slices, and its thickness is equal to or less than the thickness of single dosage form on dosage form heap axis.Sliding part 124 slides between dosage form cartridge case 102 ends and firm, and spring 120 promotes medicines and piles the opposite side that the first dosage form 48 is placed on wiper 124 near firm face like this.Wiper 124 comprises acceptance division 128, and its size relatively cam disc receives the first dosage form 48.Exemplary cartridge case drug administration mechanism comprises column type, strip/adhesive tape (ribbon/tape) type, dish-type, screw type, barrel shape, rotating disk/spring loaded type, funnel (hopper) type, conveyor-type, serialgram dosage form, shrink wrapped type, chucking type, rail type, bucket lock, adhesive tape type, band tape type, single dose applicator, and stacked-foil (foil on stack) type.
Dispensing apparatus of the present invention can pass through manual activation button, control stick, sliding part, roller, or other actuator or mechanism's granting dosage form, described mechanism is selected from: mechanically actuated, electro-mechanical activates, spring loads and activates, pneumatically actuated, hydraulic actuation, magnetic actuation, gravity-actuated, thermal actuation, burning actuating, phase transformation expansion or shrink activates, sound wave activates, and absorbs actuating mechanism.Described device is provided dosage form by the actuator of microprocessor control.
The drug administration mechanism that is used for the dispensing medicament dosage form can comprise machinery or the electro-mechanical device of dispensing medicament dosage form.
Medicine sending trap of the present invention can comprise the device of dispensing medicament dosage form, described device comprises push rod, connects path or passage, the sending trap inside of cartridge case and sending trap outlet or is positioned at one or more sealing members that sending trap exports, or any combination of these features.Fig. 4 A shows exemplary dispensing apparatus with push rod design to 4D, and described push rod is used for promoting pharmaceutical dosage form (for example tablet) makes it be used for the passage of sending of delivering drugs dosage form by design.Push rod and pharmaceutical dosage form can comprise feature or the form that allows optimization process and delivering drugs dosage form, comprising interacting with the delivery path of delivering drugs dosage form process or passage and sealing member.Fig. 4 A is the sketch map that the delivering drugs dosage form arrives the exemplary dispensing apparatus of oral mucosa to 4D, wherein shows and make the minimized device of saliva that enters dispensing apparatus in the distribution process of medicine being provided to the patient.Fig. 5 and Fig. 6 are the sketch maps of providing the exemplary shape of end, and described granting end prevents contacting of one or more sealing members and dampness or moist surface.Figure 23 A and 23B provide the explanation of illustrative drug shape.Figure 19 A-19F is the sketch map of the geometry of another exemplary cut type diaphragm seal, and it is designed in delivering drugs dosage form process, keeps the uniform sealing on every side of pharmaceutical dosage form and push rod.
Fig. 8 C and 8D are at the sketch map of fetching the dispensing apparatus 100 that the position has drug administration mechanism.Fetching the position, motor 106 rotating cam dishes 108 are regained sliding part 124, and allow to place in acceptance division 128 the first dosage form 48.Fig. 8 C shows sliding part 124 and withdraws by cam disc 108 rotations, and is subjected to displacement by spring 118.On this position, pharmaceutical dosage form 48 is advanced reception cup 126 parts of sliding part 124 by spring 120.
Fig. 8 E and 8F are the sketch maps that has the dispensing apparatus 100 of drug administration mechanism for the delivering drugs dosage form in issuance location.In issuance location, motor 106 rotating cam dishes 108 extend sliding part 124 with the first dosage form 48, and allow to provide the first dosage form 48.Fig. 8 E shows cam disc and rotates to drive sliding part forward also through sensor 114 and by sealing member 112 granting dosage forms 48.Sliding part 124 continues mobile until the dosage form that has removed from the medicine heap freely falls or promoted and granting from receiving cup 126 forcibly by alligator clamp 116 from reception cup 126.
Fig. 8 G or 8H are the sketch maps of optics sense mechanism, and described mechanism sends for detection of the pharmaceutical dosage form of dispensing apparatus 100, wherein show the position of sliding part 124 and pharmaceutical dosage form 48.In this embodiment, sliding part 124 comprises installs the groove 130 send sensor 114, thereby so that sends sensor 114 and will detect the process of pharmaceutical dosage form 48 and send.When sliding part 124 promoted pharmaceutical dosage form 48 through optical pickocff 114, optical pickocff 114 record interrupt signals showed in the described cup of sliding part 124 to have pharmaceutical dosage form.If in the described cup of sliding part 124, optical pickocff 114 can not record interrupt signal to pharmaceutical dosage form 48 so, this shows that dosage form 48 does not exist.
In another embodiment, but the long band of the dosage form that is encapsulated between elasticity vesicle layer and paillon foil or the zone of fracture or dosage form array are provided.Impeller is placed on the dosage form top, and is pushed to vesicle after actuating, but makes dosage form pass paillon foil or tomography, thereby provides dosage form.
Fig. 9 A, 9B and 9C show the extra embodiment of dispensing apparatus of the present invention, wherein show arrowband type drug administration mechanism 134.Fig. 9 A shows the drug administration mechanism that is in resting position, and Fig. 9 B shows the drug administration mechanism that is in the position of getting it filled, and 9C then shows the drug administration mechanism that is in issuance location.Described mechanism comprises that utilizing adhesive attachment to grow a lip-deep dosage form is with or the dosage form array.In order to provide dosage form 48, be with 136 in roller 140 rollings, the surface that is stained with like this dosage form 48 forms convex shape, thereby peels off dosage form 48 from binding agent.In the embodiment that illustrates, can comprise that stripping film 142 peels off pharmaceutical dosage form 48 with auxiliary from binding agent.
Figure 10 shows the extra embodiment of drug administration mechanism 134, wherein shows the difformity of sheet glass 150.In another embodiment, can utilize air pressure to remove dosage form 48 or force single dosage form 48 from drug administration mechanism with auxiliary.For dispensing medicament dosage form 48, be with 136 in roller 140 rollings, the surface that is stained with like this dosage form 48 forms convex shape, thereby peels off dosage form 48 from binding agent.Can comprise that stripping film peels off dosage form with auxiliary from adhesive tape 136.Can comprise that stripping film 150 peels off dosage form 48 with auxiliary from binding agent.
Figure 11 A and 11B show another embodiment of dispensing apparatus of the present invention, wherein show the dish-type drug administration mechanism 152 at resting position (Figure 11 A) and issuance location (Figure 11 B) employing dish-type cartridge case.Drug administration mechanism 152 comprise with lever handle 150, the tooth bar/impeller 153 of the tooth of gear 151 engagement, and the passage 154 in the housing, and spring 156.Passage 154 moves freely it for tooth bar/impeller 153 provides the space in passage 154.In Figure 11 A, tooth bar/pusher 153 is ready to promote dosage form 48.When lever handle 150 is pushed down, spring 156 compression and gear 151 rotates and tooth bar/impeller 153 engages with dosage form 48.Dosage form 48 is pushed in passage 154.Figure 11 B shows the pharmaceutical dosage form 48 that the treatment target from passage 154 ends to for example people is provided.So repeat these steps to continue dispensing medicament dosage form 48.
Figure 11 B illustrates the extra means of dispensing medicament dosage form, wherein also shows the dish-type drug administration mechanism that is in issuance location 154.This accompanying drawing shows the impeller that is positioned at issuance location, and it is released dosage form 48 the dish-type cartridge case and pass through sealing member 143.After housing 144 was sent, return spring 156 made drug administration mechanism return and cam disc/ratchet 145 by rotation dish-type cartridge case and adjusts this cartridge case in described dosage form, thereby so that next dosage form 48 is in the appropriate location of next time sending.
Can use dish-type to send with rotating disk mechanism with from delivery device delivering drugs dosage form of the present invention.The dish-type delivery mechanism can activate with manual or electric mechanical mode, and can adopt driving screw, gear, mechanism, connecting rod, rotary actuation or any other propulsion mode so that delivery mechanism can the delivering drugs dosage form.Can cam disc, escapement, driving screw, gear transmission chain, connecting rod, motor or other motor-driven or other rotating disk mode realize the rotating disk ratchet.
Dispensing apparatus can be pre-charged with the pharmaceutical dosage form of some, has just stored medicine when this sampling device is purchased in device, perhaps can fill medicine at the scene, pharmacy, perhaps can fill medicine by nurse or other health professional in hospital.Pharmaceutical dosage form can be packaged into the tablet group of holding with bottle, bottle or other container, and perhaps pharmaceutical dosage form can be with controlled direction encapsulation in cartridge case.Cartridge case can hold the dosage form of any collocation form, comprises heap, row, disk, circular arc dish, band, adhesive tape, helix or above any type of array or combination, for example, piles with a plurality of medicines that geometric array is arranged.The present invention further provides the additional method of dispensing medicament dosage form, comprised the combination of these or other mechanism.For example, system can comprise the reciprocator that removes pharmaceutical dosage form from pharmaceutical dosage form heap, and forces impeller that pharmaceutical dosage form is released from system.
Figure 12 A shows exemplary push rod 158 for dispensing medicament dosage form 48 to 12C.Push rod can by any suitable material, be made such as rustless steel.
Figure 13 and 14 shows other the exemplary drug administration mechanism with push rod for the dispensing medicament dosage form, and wherein push rod is designed to flexible.Figure 13 shows drug administration mechanism 174, it is by means of the elastic rod 176 on the propulsive mechanism that is attached to turning cylinder for example, separate (singulating) pharmaceutical dosage form and also advance pharmaceutical dosage form to pass through non-linear or linear passageway, thereby in non-linear or linear passageway, advance or regain elastic rod to allow providing tablet or other dosage form 48 by non-linear channels.Figure 14 shows drug administration mechanism 180, it is by means of being attached to such as the elastic rod 182 on the propulsive mechanism of turning cylinder, separate drug dosage form 48 also advances pharmaceutical dosage form 48 by non-linear or linear passageway, thereby advances in non-linear or linear passageway or regain elastic rod to allow providing tablet or other dosage form 48 by non-linear channels.
In relevant method, similar with above-mentioned embodiment, dispensing apparatus of the present invention comprises the cast cartridge case, and described cartridge case comprises the medicine heap, promotes spring, firm and sliding part or the impeller of medicine heap.In this embodiment, sliding part or impeller lack the hole, but regain from dosage form heap below, thereby make it be close to firm so that spring can promote pharmaceutical dosage form.In the process that activates impeller, promote to put out lateral groove perpendicular to the first dosage form in the medicine heap of cartridge case and with it, the thickness of described impeller equals, is greater than or less than the thickness of single dosage form.
In yet another embodiment of the present invention, provide dosage form by mobile dosage form heap, described dosage form piles up the one end impeller is installed, and elastic diaphragm is installed to keep the opposite end of dosage form heap.Barrier film has micropore or hole in the position of the first dosage form.After activateding, impeller promotes the dosage form heap and single dosage form reveals from membranes pores, and slightly withdraws so that the elastic diaphragm resealing is also closed again at this position impeller.Elastic diaphragm can be sealing member or wiping type sealing member.
Figure 15 A shows exemplary locking mechanism to 15F.Figure 15 A illustrates putter type locking mechanism 186.When pressing push rod 188,190 pairs of signals of solenoid are reacted and the mobile return lock 192 that is in the locked position, thereby prevent dispensing apparatus dispensing medicament dosage form 48 in lockup period.Figure 15 B shows actuator type locking mechanism 196.During push rod 200 in pressure-locking mechanism 196, latch fitting 198 is in response to the movement of push rod 200, auxiliary lower mobile with lock actuator at solenoid 202.Figure 15 C and 15D show respectively safety switch/dog-type locking mechanism 204 and 214.In the accompanying drawings, claw 206 is locked in latched position with push rod 210.The patient promotes sending trap 212 and exposes button 208 with release claw 206.Figure 15 E shows solenoid I type locking mechanism 216, and wherein solenoid moves to lock dispensing apparatus.Figure 15 F shows another solenoid type locking mechanism 218.Solenoid 220 moves and locks dispensing apparatus pressing the button at 222 o'clock.
Figure 16 A provides the sketch map of exemplary cartridge case to 16D, and described cartridge case comprises barrel shape cartridge case 224, rotating disk (index)/spring loaded type cartridge case 230, discharge type (snap-out) cartridge case 244 and rail type cartridge case 250.Figure 16 A has described barrel shape cartridge case 224, and it is provided the pharmaceutical dosage form 48 of stacking in each barrel 228 and rotates when each the actuating.Figure 16 B shows rotating disk/spring loaded type cartridge case 230.When tooth bar 232 is pressed impeller 234, spring 240 is used for the compression that is applied on the pharmaceutical dosage form 48 that is stacked at cartridge case 242 is minimized, and push rod 238 promotes pharmaceutical dosage form 48 to provide.Figure 16 C shows chucking type cartridge case 244.In cartridge case 244, keep the stub of pharmaceutical dosage form 48 to move and push rod 248 promotion pharmaceutical dosage forms 48 to push rod 248, and when providing end, be stuck on the stub.Figure 16 D shows rail type cartridge case 250.The pharmaceutical dosage form 48 that is deposited in the track is provided.
To be pharmaceutical dosage form promote sketch map by sealing member by push rod for Figure 17 A and 17B, and wherein the geometry of sealing member and pharmaceutical dosage form and push rod adapt.Sending trap 254 shown in Figure 17 A comprises pharmaceutical dosage form 48, cartridge case 255, barrier film or sealing member 256 and push rod 257, and wherein pharmaceutical dosage form is stacked in order to providing.In the sending trap 254 in Figure 17 B, pharmaceutical dosage form 48 is promoted by barrier film 256 by push rod 257, and the geometry of its septation 256 and the shape of pharmaceutical dosage form and push rod adapt.
Figure 18 is the sketch map of exemplary push rod 260, pharmaceutical dosage form 48 and diaphragm type sealing member 264.Exemplary cut type diaphragm seal 264 is designed to keep uniformly sealing around pharmaceutical dosage form 48 and push rod 260 in delivery process.In addition, transport the mode of pharmaceutical dosage form by sealing member, wiper, door, absorbent etc. and comprise and use push rod or reciprocator that described push rod or reciprocator are become restriction saliva to enter by specialized designs and handle tablet by element.
Figure 19 A is the geometry 266,268,270,272,274 and 276 of other exemplary cut type diaphragm seal to 19F, and described seal designs becomes to form uniformly sealing in delivery process around pharmaceutical dosage form and push rod.Exemplary cut type diaphragm seal is designed for and forms uniformly sealing in delivery process around pharmaceutical dosage form and push rod.In addition, transport the mode of pharmaceutical dosage form by sealing member, wiper, door, absorbent etc. and comprise and use push rod or reciprocator that described push rod or reciprocator are become restriction saliva to enter by specialized designs and handle tablet by element.
The optimal way that activates dispensing apparatus of the present invention is mechanical system, for example manual activation button, lever, sliding part, runner or other actuator.But, drug delivery device of the present invention can be dependent on the actuating mode that substitutes, comprise that mechanically actuated, electro-mechanical activates, spring loads and activates, pneumatically actuated, hydraulically actuated, magnetic actuation, gravity-actuated, thermal actuation, burning actuating, phase transformation expansion or shrink activates, sound wave activates, and absorb and activate.
Described device can use various machineries or electric mechanical method that pharmaceutical dosage form is advanced oral cavity or space, Sublingual.For example, in case activate, pharmaceutical dosage form just can be promoted forcibly by spring, compressed air or other mechanism.
The invention provides exemplary architecture, described framework comprises the reusable option.The reusable device is capable of washing, charging, heavy cartridges or empty internal memory and be used again after treatment.Pharmaceutical dosage form sending trap of the present invention comprises a plurality of elements that assemble, thereby so that one or more element reusable, to allow the multiplexing of element expensive or high value and to cut the waste, and one or more elements are droppable, to allow to abandon easily element dirty or that pollute, cause the element of infectious disease harm or comprise the element of the medicine that can't use or pollute.In this illustrative embodiments, sending trap system, droppable pharmaceutical dosage form cartridge case can be loaded into the droppable part of sending of sending trap.The reusable part of sending trap can be connected to can abandon part, provides like this to stop the locking of distorting between element.The reusable part of sending trap can detect the cartridge case of sending trap and can abandon the suitable assembling of part, confirms the normal use of suitable assembling and permission sending trap.Improper or incomplete assembling can cause that the reusable of sending trap partly locks and shows error code or show error diagnosis.
The assembly of two or more elements of sending trap can comprise that locking mechanism is to prevent or to stop its Chinese medicine to be tampered or migrate.Locking device can solenoid, motor, piezo-activator, pneumatic or hydraulic actuator, shape memory actuator, chain shot (latch), bearing pin, clamp (snap), sliding part, connecting rod or other machinery or electro-mechanical device.Further, locking device can the physics key, password, electron key, magnetic key, password, PIN, encryption or screw unlocking manner unencrypted logical signal, wireless signal, RFID, fingerprint recognition or other machinery or electric mechanical locking or release.
After using sending trap, and when disassembling, in the time can abandoning part and can be abandoned, available part or part group can keep for using in the future.
Figure 20 A is the sketch map that comprises the exemplary architecture 278 of reusable head.Reusable partly comprises: reusable head 280, main body 282 and charging station 284.This embodiment 278 comprises: reusable head 280, and it comprises power supply 277, microprocessor and printed circuit board (PCB) (PCB) 275, actuator 273, user interface 279, customer identification device 281; Can abandon main body 282, it comprises droppable cartridge case 48; And charging station 284.In this embodiment, reusable head 280 with lockable mode with can abandon main body 284 and be connected or disconnect.After use, can abandon main body 282, pharmaceutical dosage form and cartridge case 48 and be abandoned, and reusable head 280 clean after and be docked with in the charging station with charging.Power supply 277 can be chargeable or replaceable battery, fuel cell or to any alternate manner of device power supply.Actuator 273 can be any other device of motor, solenoid, linear actuators, piezo-activator, shape memory actuator, fluid power or pneumatic actuator or actuating mechanism.User interface 279 can comprise figure or character display, keyboard, button, switch, driver plate, sliding part, light, LED, LCD, speaker, microphone, buzzer or with any other device of user's two-way communication.Any other device of LAN, DNA recognition system, retina scanners or personal user and patient that customer identification device 281 can be RFID label reader, Wi-Fi system, fingerprint reader, speech recognition system, image or facial-recognition security systems, communicate in the human body mode.Cartridge case 48 can be heap, dish, band, single dose applicator, and can hold single dose or multiple dose.Any other element or system that printed circuit board (PCB) 275 can comprise processor, storage device, power regulator, charging circuit, patient's recognition device, graphics driver device and affect dispensing apparatus 278 performances.Drug administration mechanism can be contained in can be abandoned in main body 282 or the reusable head 280 or partly be contained in the two.Charging station is 284 chargeable, can carry out the diagnosis of reusable head 280, or as the information connecting device use, in wired or wireless mode at dispensing apparatus and other device, computer or inter-net communication.
Figure 20 B is the sketch map of exemplary architecture 286, and exemplary architecture 286 has reusable head 280, can abandon main body 290, POP 292, and charging station 284.Wherein, reusable head 280 holds actuator 273, printed circuit board (PCB) 275, power supply 277 and customer identification device 281, can abandon main body 290 and hold cartridge case and pharmaceutical dosage form 48, and POP 292 holds communicator and user interface 279.The reusable option comprises: reusable head 280, can abandon main body 282, POP 284 and POP 292.
Figure 20 C is the sketch map that comprises the exemplary architecture 294 that can abandon main body, described abandon main body comprise actuator 273, printed circuit board (PCB) 275, power supply 277, customer identification device 281 and hold pharmaceutical dosage form 48 cartridge case, hold the portable connecting device 296 of user interface 279 and charging station 284.The reusable option comprises: with the main body abandoned 282 of portable connecting device, and be the charging station 284 of portable connecting device charging.
Figure 20 D is the sketch map that comprises the exemplary architecture 302 of the main body abandoned 282 with the ability of plugging into.The reusable option comprises: hold the main body abandoned 282, printed circuit board (PCB) 275, power supply 277, the customer identification device 281 of actuator 273 and the cartridge case that holds pharmaceutical dosage form 48, and the POP 292 that holds user interface 279.The reusable option comprises: with the main body abandoned of POP.
Figure 20 E is the sketch map of exemplary architecture 308, and exemplary architecture 308 has reusable head 280, can abandon main body, portable connecting device 296 and the charging station that is used for head and portable connecting device.
In one embodiment, the present invention further provides complete droppable device.Described device be integrated for the medicine granting and with after can abandon the single-piece of necessary all elements, it comprises power supply 277, microprocessor and printed circuit board (PCB) (PCB) 275, actuator 273, customer identification device 281, the cartridge case that holds pharmaceutical dosage form 48 and user interface 279.Figure 20 F is the sketch map of exemplary architecture 318, wherein shows complete droppable main body 282.
The present invention further provides the dispensing apparatus with lock-in feature, described dispensing apparatus comprises removable push rod; Irrevocable push rod; The electric mechanical adjustor; Optical pickocff pair; The magnetic hysteresis shaft coupling; Locking in the brake; The rack-and-pinion device; The safety switch door; Electromagnetic valve; Collet chuck on the axle; Axle with keyway; Shaft coupling; And cam.
Dosage form is given patient's system
Adopt system dispensing apparatus of the present invention, that give the patient with dosage form to comprise dispensing apparatus, pharmaceutical dosage form and patient.The additional features that can comprise in the system be POP or other connecting device, with the communicator of computer system, as with Local or Remote computer system (wired or wireless) two-way communication connection, medicine network monitoring and control appliance, storage, record set transmission from as described in the computer network of information of device and the relevant drug delivery of one or more user interfaces.
In a method, the computer network of dosage form delivery system of the present invention can comprise one or more: store, record, receive, send the device from the relevant drug delivery information of described device and one or more user interfaces; The internal clocking on writing time and date, replacement or revise memorizer device, measure the non-intruding device of breathing rate, temperature, pulse rate or blood pressure, wherein measurement result stores and by the computer network transmission; Change the device of the locking time of dispensing apparatus or sending trap.Can play at the POP of implementing to adopt when of the present invention fetch, store, to another device, outer if the effect that computer transmits data and/or charges to battery.Described system further comprises one or more user interfaces and such as the pictorial displays of LCD display.
Figure 21 is the sketch map of the function element of medicine delivery system 326, and it comprises dispensing apparatus and with the medicine network of the monitoring and controlling equipment by wireless or the coupling of other bidirectional communication network.System 326 comprises the microprocessor 352 of battery 342 controls, described microprocessor comprises that RAM330 is connected with ROM320 and operationally is connected with the adapter 352 of plugging into, and carry out communicating by letter with RFID antenna 336, WI/FI antenna two-wayly, wherein dispensing apparatus and medicine network further comprise user interface 328, audible alarm 350, pictorial displays 348, provide button and sensor 346, and provide button locking device 344.Device of the present invention or dispensing apparatus can comprise the bidirectional communication link with the Local or Remote computer system, and wherein computer system provides signal to allow described device to provide the small size pharmaceutical dosage form.The small-volume oral transmucosal pharmaceutical preparation of multiple dose can be stored and provide to drug delivery device.Device/system 326 comprises the storage device such as RAM330 and/or ROM332, microprocessor 352 or central processing unit (CPU) are with the various functional elements of process information and control device 326 and battery 342, allow device 326 to be connected to another device, outer if computer is to fetch, storage, outer if computer transmits data to another device, and the adapter 334 of plugging into that charges to battery 342, other unique label of RFID antenna or each isolated system 326 of the convenient identification of permission, the Wi/Fi antenna 338 of information communication is carried out in permission two-wayly by wireless system, be placed on the granting sensor that outlet is successfully provided with the detection of drugs dosage form.
Figure 22 A is the block diagram of system communication schematic diagram 354, and described system communication schematic diagram comprises RFID label 356, sending trap 358, base station/connecting device 360 and health care provider personal computer 362.Medicine sending trap 358 can be communicated by letter with doctor or health care provider by portable connecting device 366 with the wired or wireless communication method, provides use information and relevant patient's breathing state or the information of blood pressure with fixed interval to the doctor.
The block diagram of Figure 22 B system communication schematic diagram 364, described system communication schematic diagram comprises RFID label 356, dispensing apparatus 358, portable connecting device 366 and health care provider personal computer 362.Sending trap 358 can be communicated by letter with doctor or health care provider by portable connecting device 366 with the wired or wireless communication method, provides use information and relevant patient's breathing state or the information of blood pressure with fixed interval to the doctor.Can change portable connecting device 366 to connect cotton rope so that portable connecting device 366 can be suspended on the neck of doctor or health care provider.This will help avoid such as misplacing of the portable connecting device 366 under in hospital configuration and put or portable connecting device 366 stolen.
Medicine delivery system provided by the invention comprises dispensing apparatus and detects the checkout gear of patient identity.Delivery system can further comprise computer, POP, access control apparatus and small size pharmaceutical dosage form.System further comprises POP, and wherein POP is electrically connected with computer network and information is transferred to computer network from drug delivery device or dispensing apparatus.Computer network is wireless network, and information from drug delivery device or dispensing apparatus by wireless network transmissions to computer network.Computer network storage, record and the information of transmitting from the relevant drug delivery of drug delivery device.Described system further comprises the non-intruding device to measure breathing rate, pulse rate, temperature or blood pressure, and wherein measurement result is stored and by the computer network transmission.In one embodiment, system further comprises the change dispensing apparatus device of locking time.In another embodiment, system can comprise the drug delivery device with the antagonist storage chamber, to allow mixing antagonist and medicine in the situation of system or power failure, device damage or abuse.In addition, also provide the device that uses sensor to detect hematochemistry feature, breathing chemical feature, sialochemistry feature etc.
The further embodiment of described device comprise the ability of storing historical use information and with another device or the compunication ability with the device that transmits this information.For example, the two-way exchange of information can be downloaded to computer with canned data by the physics wireline interface such as USB or any other communication connection and realizes.Alternatively, can pass through the wireless system transmission information.This information can comprise historical use information, for example medicament storage and discharging quantity, and provide number of times.
In some embodiments, described device comprises POP, described POP can to device inquiry, reset between the administration, when suitably not accessing locking, and control dosage regimen.Dispensing apparatus can be communicated by letter by connecting device in the mode of wired or wireless communication with doctor or health care provider use information and relevant patient's breathing state, blood pressure or other biometric information are provided to the doctor with fixing interval.Described dispensing apparatus can be in every day or weekly or the locking of fortnightly fixed interval or time cycle, needs plug into dispensing apparatus and be the described device of next fixed time period release with doctor or health care provider of patient.By this way, described device and connecting device are doctor's grantings of can better supervising and keep healthy.
In other embodiment, POP can load single dose or multiple dose to described device when described device is plugged into and be correctly accessed.
In some embodiments, described device can be suitable for receiving the cartridge case of the single dose applicator of independent encapsulation, and wherein each single dose applicator is held the medicine of single dose.
Medicament sending trap of the present invention can be used to provide to dampness and/or the responsive pharmaceutical dosage form of appropriateness.In this case, need to provide protection with isolation humidity, dampness, saliva, mucus etc. to pharmaceutical dosage form.Cartridge case can be that cylindrical, dish type, spiral type, linear, non-ordering type maybe can adopt and allow sending trap with any medicine spread pattern of controlled mode dispensing medicament.In order to prevent before use absorbing moisture or be exposed to dampness of untapped pharmaceutical dosage form, cartridge case can provide the device of sealing pharmaceutical dosage form to be exposed in the dampness to prevent it.Hold the cartridge case of the independent encapsulated drug dosage form that is separated by waterproof thin film or impermeable material by use and realize above-mentioned target, when providing a pharmaceutical dosage form from cartridge case, the sealing member of protection residual drug dosage form keeps not damage state based like this.Alternatively, two or more pharmaceutical dosage forms can be encapsulated in each independent sealed spacer in the cartridge case.In some embodiments, all pharmaceutical dosage forms in the cartridge case can be encapsulated in the interval of diaphragm seal together.
Cartridge case can in mode or the mode to seal with another element to sending trap of barrier film, elastic sealing element or valve, sliding part, translation part, hinged door or valve, provide the sealing to dampness when loading.Under this mode, but the sealing member of independent resealing can be independently or is opened in the mode that medicine leaves the passage of cartridge case.In case pharmaceutical dosage form is sent from cartridge case, but the sealing member of the resealing on the resealable cartridge case is to prevent the pharmaceutical dosage form in dampness or other contaminants cartridge case.But cartridge case can further comprise non-resealing spare, but described non-resealing spare is just destroyed when it is loaded into sending trap or sends the first pharmaceutical dosage form from cartridge case.
In other embodiments, cartridge case holds desiccant or other absorbent or absorber material used before or entered in using cartridge case with absorption or absorption dampness.But but be used in any combination that cartridge case in the dispensing apparatus of the present invention can hold the pharmaceutical dosage form of independent sealing, multi-sealed pharmaceutical dosage form resealing sealing, non-resealing sealing, desiccant, absorbent or adsorbent.
In an illustrative embodiments, a pile solid tablet dosage form is encapsulated in the cylindrical cartridge case and the spring that has sliding seal and tablet is pressed to this end in its end.When putting into cartridge case in the sending trap, sliding seal remains on original position, with medicament protection impact with blocks moisture and humidity in cartridge case.When dispensing medicament, sliding seal skids off original position, and spring is able to the promoting drug heap, provides so independent Tabules.In case provide this tablet, sliding seal is mobile to continue the remaining tablet of sealing to prevent the impact of dampness and humidity backward.
In second illustrative embodiments, the a pile solid tablet is encapsulated in the cylindrical cartridge case and in its end has foil seal, tablet is pressed to the spring of this end, and sealing surfaces, the element that be positioned at sending trap inside of described sealing surfaces after to the sending trap of packing into implemented sealing.When cartridge case was put into sending trap, foil seal was suffered breakage, and the element of the end seal sending trap of cartridge case is not subjected to the impact of humidity and dampness with the protection pharmaceutical dosage form.When providing tablet, provide the element of the sending trap of sealing to shift out original position to cartridge case, single dosage form is provided.In case provided described dosage form, sending trap then reseals cartridge case, and protection residue dosage form is not subjected to the impact of dampness and humidity.
In the 3rd illustrative embodiments; dish-type cartridge case loading solid Tabules also is not subjected to the impact of dampness and humidity with the two sides of foil sealing pharmaceutical dosage form with the protection tablet, and described dish-type cartridge case is placed the independent space of independent solid tablet dosage form in its periphery.When pharmaceutical dosage form was loaded in the sending trap and is issued, push rod pushed away brokenly a paillon foil on the side at independent interval, contacts with Tabules, and the second sealing member that is positioned at dish-type cartridge case opposite flank is passed in its promotion, wears out the second paillon foil, concurrent film releasing agent.By this way, only provide independent tablet, and the sealing member of residue tablet still keeps damaged, be not subjected to the impact of dampness and humidity with the protection tablet.After providing tablet, the next one that is located at interval at that position of diskware rotation holds next tablet is like this treated issuance location.Figure 11 A and 11B show this illustrative embodiments.
The dosage form of sending with dispensing apparatus of the present invention
The oral transmucosal drug delivery be effectively, easily, non-invasive sending, and can be provided and patient uncomfortable minimum by health care provider or patient.The oral transmucosal delivery normal operation of medicine is the solid pharmaceutical dosage formulation of rhombus for example, still, also can use liquid, spray, powder, chewing gum, foam, adhesive plaster and thin film.Dispensing apparatus of the present invention provides the device of sending the small size pharmaceutical dosage form, and described device is suitable for by the oral mucosa delivering drugs.
In one embodiment, dispensing apparatus of the present invention provides the device of oral transmucosal delivery medicinal activity material.Dosage form can be solid or non-solid, and can be used as the delivery vector of any medicine, and described medicine can comprise such as the analgesic of class Opium or class Opium effectual drug or treatment angor, anxiety, insomnia, hyperkinetic syndrome, habit-forming, the medicine of feeling sick etc.The solid dosage forms that can be used for sending by oral cavity mucous membrane tissue thinks also that within the scope of the present invention described solid dosage forms for example is sublingual dosage forms, tablet, lozenge, powder and thin film.
The present invention also comprises the dispensing apparatus of sending other non-solid dosage form, and described non-solid dosage form is such as being gel, ointment, paste, mist agent, liquid, aerosol, gas, steam, foam, emulsus agent, spray, suspension etc.
In one embodiment, dispensing apparatus of the present invention provides the device of sending the small size pharmaceutical dosage form, in this example as pain therapy.In this embodiment, pharmaceutical dosage form is designed so that it remains on Sublingual zone and is attached on the oral mucosa, and enough little so that patient makes seldom or do not go out ptyaloreaction.Although pharmaceutical dosage form will remain in the space, Sublingual, this pharmaceutical dosage form all can be effective when absorbing by any oral transmucosal mode.
In one embodiment, dispensing apparatus of the present invention is used for the giving of small size drug delivery dosage form of oral transmucosal drug delivery, and wherein said dosage form encapsulates in advance and provides voluntarily.The present invention also comprises and uses described device to send for the small size drug delivery dosage form of the oral transmucosal drug delivery of encapsulation in advance not.
Be used for when oral transmucosal gives pharmaceutical dosage form, making the minimized device of saliva that enters dispensing apparatus comprise sealing member, wiper, sorbent, air gap, desiccant and multistage delivery system.Described dispensing apparatus is once provided a kind of pharmaceutical dosage form, and can not produce adverse influence to the other medicines dosage form that is contained in the cartridge case of filling pharmaceutical dosage form.
One preferred embodiment in, dispensing apparatus of the present invention provide send usually as
The device of very little pharmaceutical dosage form.
Can be used for sending any can be by the oral transmucosal approach, to be easy to by undersized
The medicine of the amount administration of administration, that is, and about 0.1 milligram to about 99.9 milligrams.One preferred embodiment in,
Be attached to the Sublingual.
Described dosage form can contain the active component of 0.01%-99%w/w usually with the weighing scale of active component or " medicine ".Term used herein " medicine " means any " medicine (drug) ", " activating agent ", " active ", " medicine (medication) " or " therapeutic activity agent ".In some embodiments, described pharmaceutical dosage form is
It can be used for sending any can be by the oral transmucosal approach and should pass through small size
The medicine that the amount that gives gives, for example, the amount maximum of described medicine can reach 99.9 milligrams, 0.25 microgram to 99.9 milligram for example, 1 microgram to 50 milligram, perhaps 1 microgram to 10 milligram.
Shape at the pharmaceutical dosage form of implementing to use when of the present invention preferably is roughly dish type, but can be rectangle, square, ellipse or sphere, above any combination, maybe can be asymmetry.When being dish type, plane surface provides the surface area that increases to be beneficial to adhere to and the medicine elution.Pharmaceutical dosage form can present any shape, and by adopting dispensing apparatus granting of the present invention.Most preferably, the shape of pharmaceutical dosage form is the circle with plane, concave surface and convex surface.Alternatively, they also can be the ellipses with plane, concave surface and convex surface, perhaps with 3 or polygon more polygon and plane, concave surface and convex surface.Pharmaceutical dosage form also can be sphere, ellipsoid or any other curved body.Pharmaceutical dosage form also can be any asymmetrical shape, and can carry out specifically processing and arranging in dispensing apparatus and in the put procedure.
Figure 23 A and 23B show the exemplary shape of medicine.Figure 23 A is the sketch map of symmetrical pharmaceutical dosage form 368, comprising ellipse, the sphere of the disc of the plane, concave surface or convex surface, the plane, concave surface or convex surface, have 3 or polygon more polygon and plane, concave surface or convex surface.Figure 23 B is the sketch map that is the other medicines shape 370 of asymmetric pharmaceutical dosage form.
In an illustrative drug dosage form, described pharmaceutical dosage form is dish type roughly, and the pharmaceutical dosage form volume is about 5 microlitres, and about 0.85 millimeter of the thickness of pharmaceutical dosage form, and 3.0 millimeters of diameters.
Medicine dispensing apparatus of the present invention provides the multi-medicament dosage form, and described pharmaceutical dosage form can characteristic and the quantity according to active component change when the size that keeps being suitable for high-efficiency delivery and feature.
Device of the present invention can once load the medicine for many days (for example 30 days or more), and medicine does not need special encapsulation.Alternatively, medicine can provide with the form of pre-filled cartridge case.
Advantage of the present invention is that medicine is sent by dispensing apparatus, described dispensing apparatus provides the multiple dose granting of small-volume oral transmucosal drug delivery dosage form, can obtain like this to have appropriate dose and the frequency of therapeutic efficiency, described dispensing apparatus provides simultaneously and timely locks characteristic to prevent accidental overmedicate.Pharmaceutical dosage form and corresponding locking time can be adjusted according to the size of medication object and the therapeutic goal of expection.
As mentioned above, medicine dispensing apparatus of the present invention is included in and makes the minimized device of saliva that enters described device when described device is used for the oral cavity granting.In this embodiment, described dispensing apparatus is once provided a kind of pharmaceutical dosage form, and can not produce adverse influence to the other medicines dosage form that is contained in the cartridge case of filling pharmaceutical dosage form.Collect or isolation has entered the saliva of described device or the mode of dampness includes but not limited to hydrophilic absorbing material or composition, absorption or adsorbing material or composition or desiccant material or composition, perhaps any combination of these materials or composition.
Indicate by drug type and treatment that sending trap is sent
Any can all can be used in the method and system of the present invention with the medicine of the pharmaceutical dosage form granting that is fit to dispensing apparatus of the present invention.
Similarly, dispensing apparatus of the present invention can be used for processing the situation that the described device of any employing is sent suitable pharmaceutical dosage form.
An illustrative aspects, dispensing apparatus of the present invention can be used for the oral transmucosal delivery analgesic, such as class Opium or class Opium effectual drug, with management of acute pain or acute sudden pain.In this embodiment, dispensing apparatus of the present invention also is used for the treatment of the acute sudden pain of out-patient's setting simultaneously for the IV class Opium medicine of the acute pain treatment of hospital's configuration.Example comprises that out-patient's (hospital's configuration) wherein needs the fast treating acute pain under many different clinical settings, and described clinical setting is included in post-operative recovery under the hospital configuration, rheumatic arthritis, back decline, terminal cancer etc.For example, after patient begins several days severe pain after surgery, can experience some days slight to moderate pain.
Dispensing apparatus of the present invention allows the patient to take voluntarily analgesic drug product and other medicine, and if necessary again medication with their medication of titrimetry and obtain the therapeutic effect of expection level.
In order effectively the out-patient lower operation to be set, dispensing apparatus by patient's control should allow patient's self-administration in the situation of needs, and prevent patient's overmedicate, recording medicine is historical, allow medication history the record that reads, downloads or be sent to the patient, with pharmaceutical dosage form be delivered to the appropriate location (for example, Sublingual, oral cavity, oral cavity gastrointestinal tract, rectum, eyes, nasal cavity, suction, ear, pass skin or with other any releasing mode) and prevent or stop without permission the individual near medicine.Dispensing apparatus of the present invention can be used for providing the out-patient and lower any treatment is set so that the expection combination of above-mentioned feature to be provided.
Another exemplary application of dispensing apparatus of the present invention is in the treatment of carrying out pain, and this treatment is essential to the patient under the out-patient arranges, for example because of after chronic condition or the suddenly injured out-patient's operation carried out.Many patients weekly or take every day class Opium medicine with the treatment pain.Although the patient may have long-acting oral or transepidermal class Opium medicine, to treat its chronic potential pain, they often also need the effective class Opium of short-term medicine, to treat its serious sudden pain.This sudden pain sustainable a few minutes to several hours, several days or several week.
" field " under the height Second Optimal Condition, the processing of acute pain often are necessary.Often be required to process serious acute pain such as the first respondent of nursing staff or the doctor of army under non-conditions for sterilization, the entry needle that wherein uses in IV or IM provide can produce unexpected consequence, such as infecting etc.Oral cavity class Opium medicine often needs more than 30 minutes just can provide analgesic activity, and this is oversize for the patient who is in severe pain.The application scenario of dispensing apparatus of the present invention can comprise the angor that treatment is treated with nitroglycerine usually.
When use under inpatient chronic (in the family, office, field etc.) configuration, dispensing apparatus of the present invention provides some feature and advantage with respect to existing inpatient medicine issuing technique.Described dispensing apparatus allows individual the guidance according to doctor, health care provider or drug label to carry out the medicine self-administration.
Under above-mentioned clinical configuration, needing significantly can be safely and use easily dispensing apparatus, and prepares effective drug delivery when preventing drug dependence and migrating.
It will be understood by those skilled in the art that administration can be optimized by delivering drugs and route of delivery on the control certain hour, generally can consume active low composition simultaneously, thereby reduce side effect.
The using method that is used for the dispensing apparatus of the present invention of oral transmucosal drug delivery
Can realize using dispensing apparatus of the present invention to send single dosage form by the content of in following accompanying drawing, describing in detail.
Figure 24 is the block diagram that the programming flow diagram 372 of dispensing apparatus is shown, and wherein process comprises the steps: the tablet medicine wound packages is downloaded in the dispensing apparatus.If load successfully 374, process enters next step.If unsuccessful 376, process is returned the first step that the tablet medicine wound packages is downloaded to dispensing apparatus; Close and lock dispensing apparatus.If success 378, process enters next step.If unsuccessful 380, process is returned the back of closing and lock dispensing apparatus; Dispensing apparatus and PC are plugged into.If success 382, process enters next step.If unsuccessful 384, process is returned back; Dispensing apparatus is programmed.If success 386, process enters next step.If unsuccessful 384, process is returned back; Record fingerprint or PIN are to identify suitable user.If success 390, process enters next step.If unsuccessful 392, process is returned back; And whether the test dispensing apparatus normal administration.If success 396, process stops 398.If unsuccessful 394, process is returned the first step to proofread and correct programming.
Figure 25 is the block diagram that the operational flowchart 400 of dispensing apparatus is shown, and the step-by-step operation example of dispensing apparatus of the present invention wherein is provided.Detailed step comprises: press any button to wake sending trap 402 up.The user confirms whether the lockup period of pre-programmed finishes.If the lockup period of pre-programmed does not also finish, the user gets back to back and the repetitive routine that wakes sending trap up.If confirm to be met, then dispensing apparatus is unlocked with the dispensing medicament dosage form.Execution utilizes for example step of fingerprint, RFID or PIN input patient identity 404.If patient identity is correct 406, program enters next step: detect RFID label 410.If incorrect 414, it causes the locking of dispensing apparatus.If detection RFID label success 412, the user continues to carry out next step, and the user confirms in this step whether the device of locking does not have prevention to send and provide normal.(a) provides request, (b) provides prescription 416 historical and that (c) programme so compare.If (a), (b) consistent permission with (c) provides ready 418 from dispensing apparatus dispensing medicament dosage form of the present invention.If not ready, as then to enter dispensing apparatus locking 420.Show dispensing apparatus state and ID, to represent described dispensing apparatus ready 422.Press when providing button dispensing medicament dosage form 424.Dispensing apparatus begins to patient's dispensing medicament dosage form.When the pharmaceutical dosage form granting was finished, the time 426 of one section pre-programmed was closed in the dispensing apparatus locking.Repeat above step and provide 446 to carry out pharmaceutical dosage form in the future.
Figure 26 is the block diagram that the operational flowchart 428 of another exemplary dispensing apparatus is shown, and the step-by-step operation example of dispensing apparatus of the present invention wherein is provided.Described method comprises the steps: that the user can press any button to wake dispensing apparatus 430 up.So whether described device is confirmed the locking time of pre-programmed, such as 10 minutes, finish.If finish the locking time of pre-programmed, then attempt carrying out patient's identification, namely adopt 432, carry out the detection of RFID label.If also do not finish 434 the locking time of pre-programmed, the user returns back and the repetitive routine that wakes dispensing apparatus up.If detect RFID label success 436, then the device continuation is carried out next step and is examined machinery granting and is in the condition that works.If it is unsuccessful 438 to detect the RFID label, the user gets back to the first step.Be met 440 if examine, the release dispensing apparatus is with the dispensing medicament dosage form.Be not met 442 if examine, then point out error message to make mistakes 444 with the expression mechanical verification.If by mechanical verification, then carry out the motor-driven granting of pharmaceutical dosage form to the patient.When finishing granting, the dispensing apparatus locking is closed certain pre-programmed cycle.Repeat above step and provide 446 to carry out pharmaceutical dosage form in the future.
Adopting delivery apparatus of the present invention to carry out in another example of the program that pharmaceutical dosage form provides, program comprises step: load (1); (2) check; (3) location; And send (4).This program may further comprise the steps: (1) is with a plurality of pharmaceutical dosage form drug loading dispensing apparatus; (2) check sending state and affirmation, for example represent that with green light locking mechanism does not have prevention to send, and described device drug loading dosage form; (3) the described device in location is delivered to the patient Sublingual with pharmaceutical dosage form of the present invention; And (4) are by activating described device to patient's delivering drugs dosage form.When described device is unripe when sending, red light or other indication as seen always.Transmit the medicine release information to the health worker, receive suitable pharmaceutical dosage form to provide treatment render a service to guarantee the patient with suitable frequency thereby adjust dosage regimen.
Figure 27 is the block diagram that the operational flowchart 448 of another exemplary dispensing apparatus is shown, and the step-by-step operation example of medicine dispensing apparatus of the present invention wherein is provided.Described method can comprise the steps: that the user presses any button is in sleep pattern 450 to wake also release up sending trap 452.So the user examines the locking time of pre-programmed, whether finished such as 10 minutes.If finish 454 locking time, the system validation user is authorized to access, such as passing through user identity (for example, RFID label, fingerprint etc.) 458.If pre-programmed does not also finish 456 locking time, system returns the first step, namely wakes sending trap and repetitive routine up.If detect user identity and be authorized to 458, system continues execution and arrives next step, and in this step, system's release is to send 462.If do not detect user identity or authorize 460, system returns the first step, and wakes sending trap and repetitive routine up.In case system is unlocked, it can keep for 5 seconds 464 before re-locking.If the user presses the second button before 5 seconds finish 466, described button can dispensing medicament dosage form 468.Finish in case provide, system lock 470 is until provide trial next time.Repeat above step and provide 472 to carry out following pharmaceutical dosage form.
Figure 28 illustrates by the health professional to carry out the block diagram that exemplary sending trap is disassembled flow chart 474, and what medicine dispensing apparatus of the present invention wherein was provided progressively disassembles example.As shown in figure 28, the health professional can disassemble and abandon sending trap with safety, controlled mode.
Figure 29 is the block diagram that the acute dispensing apparatus operational flowchart 518 of exemplary inpatient is shown, and the step-by-step operation example of medicine dispensing apparatus of the present invention wherein is provided.Figure 29 shows the step-by-step operation of the acute dispensing apparatus of exemplary inpatient.
Figure 30 is the block diagram that exemplary inpatient sending trap assembling is shown and prepares flow chart 550, and progressively assembling and the preparation of dispensing apparatus of the present invention wherein are provided.
Figure 31 is the block diagram that the chronic dispensing apparatus operational flowchart 598 of exemplary out-patient is shown, and the step-by-step operation example of medicine dispensing apparatus of the present invention wherein is provided.Figure 31 shows the step-by-step operation of the chronic dispensing apparatus of exemplary out-patient.
Unless otherwise defined, all technology used herein have identical meaning with scientific terminology with the common understanding of technical field technical staff of the present invention.Although in enforcement of the present invention or test, can use and describe any method, device and material similar or of equal value at this, preferred method, device and material are described here.
Embodiment 1
The doctor determines needs of patients acute pain processing treatment.The pharmacists will comprise and expect the cartridge case of pharmaceutical dosage form of the intensity dispensing apparatus of packing into.Each cartridge case comprises that the placebo dosage form of two colours is as the first two dosage form of providing.Described device comprises the device be used to the cartridge case of packing into, and described device be used to the cartridge case of packing into is firmly and without permission to use then unapproachable outlet, wicket (hatch) or door.In case the pharmacists is with in the cartridge case charging apparatus, on the outlet that he just will install, wicket or the door lock.Then the pharmacists uses and plugs into adapter with on the connecting device that dispensing apparatus is docked with first with computer links to each other, and device is programmed.Programming is included in after device is lost again when found, upload dosage form dose intensity, be loaded in dosage form quantity in the device, preset frequency that dosage form is used, the dosage form number that uses every day, current date and time, preferred language, in order to effective fingerprint of identifying the patient or other identity and doctor's identity information.
In case dispensing apparatus is programmed, the doctor is then by providing single blue placebo to show correct use and test set.So the pharmacists gives dispensing apparatus with the patient and observes the patient and provide placebo to guarantee correct use and functional.The pharmacists also provides RF identification (RFID) key when providing dispensing apparatus to the user, described key must the device about 5 inches scopes in so that dispensing apparatus can operate.
When the patient wanted the dispensing medicament dosage form, he or she can hand dispensing apparatus, and pressed any button and will install from sleep pattern and wake up.Described device can be asked the user to carry out fingerprint and be read or input PIN (PIN).So described device can be searched for effective RFID key in scope.In case these conditions are met, described dispensing apparatus can ask its internal storage and clock to be upset by current use request with the dosage regimen of determining to be programmed by the pharmacists.At this moment, described device display status information, such as date and time, the last service time that remains dosage number, dosage form, patient's name etc., and the pharmacists notifies the ready wait of the described device of patient to provide dosage form by visible and/or acoustical signal.
The patient remains on the granting end of described device his or her Sublingual and presses the granting bar.When the dispensing medicament dosage form, the sound that can sound is to notify patient's pharmaceutical dosage form correctly to be sent.At this moment, described device can locking to prevent from further providing until finish the locking time of pre-programmed, at this moment described device is again ready etc. to be used.
Embodiment 2
Under hospital environment, wherein the patient is subject to more direct supervision, and the access of the dispensing apparatus that provides and identification are limited in the detection to the RFID key, and do not need fingerprint or PIN.The patient of postoperative or disability need not to consume unnecessary muscle power just can operate described device.Alternatively, being responsible for nurse or doctor can be to patient's dispensing medicament dosage form.The use of RFID key has prevented accidental or that have a mind to and probabilities other patient's switches.
Dispensing apparatus is by wired or wireless communication (WI-FI) and nurse station periodically contacting.The number that this will allow the health worker to monitor using of dispensing apparatus and remain dosage.WI-FI communication allows the nurse to ask fully at any time dispensing apparatus to use state historical and device to check, comprises battery life, employed dosage, uses the time, residue dosage of this dosage etc.The element of described dispensing apparatus is associated in the medicine delivery system.
Although for purpose clear and that understand, in the mode of diagram and example ratio explanation has in more detail been done in aforementioned invention, certain change and modification are obvious to those skilled in the art.Obtained different aspect of the present invention by series of experiments, in the mode of following non-limiting example some aspects wherein have been described.Therefore, illustrate with example and should not think limitation of the scope of the invention, and described scope is illustrated by the description of appended illustrative embodiments.
Claims (21)
1. dispensing apparatus that is used for the administration of oral transmucosal medicinal tablet comprises:
(a) housing, it has the granting end of sending for the Sublingual of medicinal tablet, and described medicinal tablet is configured to be sent by non-linear channels; And
(b) lock-in feature is configured to prevent that described device from providing described medicinal tablet between lockup period.
2. dispensing apparatus as claimed in claim 1, wherein said lock-in feature is programmable lock-in feature.
3. dispensing apparatus as claimed in claim 2 is the lockout interval of setting between administration between wherein said lockup period.
4. dispensing apparatus as claimed in claim 2 is regular time interval, predetermined time interval, predetermined variable time interval, the interval of being determined by algorithm and from remote computer or POP and send in the variable time interval of described device at least one between wherein said lockup period.
5. dispensing apparatus as claimed in claim 1, wherein said medicinal tablet comprises sufentanil.
6. dispensing apparatus as claimed in claim 5, the quality of wherein said medicinal tablet are 0.25 microgram to 99.9 milligram.
7. dispensing apparatus as claimed in claim 1 further comprises:
Be positioned at the cartridge assembly of described housing, described cartridge assembly comprises that at least one configuration is used for holding the granting cartridge case of one or more medicinal tablets.
8. dispensing apparatus as claimed in claim 7, wherein said cartridge assembly comprises intelligent cartridge case recognition system.
9. dispensing apparatus as claimed in claim 1 further comprises:
Intelligence cartridge case recognition system is configured to one of be used for holding in physics keying feature on the cartridge case of one or more medicinal tablets, the bar code, magnetic labels, RFID label on the described cartridge case and the electronic microchip on the described cartridge case on the described cartridge case on the described cartridge case at least via configuration and identifies described cartridge case.
10. dispensing apparatus as claimed in claim 1 further comprises patient's recognition device.
11. dispensing apparatus as claimed in claim 1 further comprises:
The patient identifies reader, and it is in fingerprint reader, optical retina reader, speech recognition system, RFID reader and the Wi-Fi system at least one that wherein said patient identifies reader.
12. dispensing apparatus as claimed in claim 11, wherein said patient identify reader be configured to object to be identified on the RFID reader that matches mutually of coupling RFID label.
13. dispensing apparatus as claimed in claim 12, wherein when the described RFID reader on the described dispensing apparatus detected coupling RFID label on the described object, described dispensing apparatus was unlocked.
14. dispensing apparatus as claimed in claim 1, wherein said granting end are configured to reduce the described dispensing apparatus of saliva inflow/enter.
15. dispensing apparatus as claimed in claim 14 is wherein said for preventing or hinder that the device that saliva enters described dispensing apparatus comprises the one or more of sealing member, wiper, absorbent, adsorbent, desiccant and air gap.
16. a dispensing apparatus system that is used for the oral transmucosal administration of medicinal tablet comprises:
(a) dispensing apparatus as claimed in claim 1; And
(b) be used for device with the computer system two-way communication.
17. dispensing apparatus as claimed in claim 16 system further comprises:
Storage device is configured to keep relevant dosage and transmits information; With
User interface is used for and user or described computer system two-way exchange information.
18. dispensing apparatus as claimed in claim 16 system, wherein said dispensing apparatus comprises the cartridge assembly that is positioned at described housing, and described cartridge assembly comprises that at least one is configured to hold the granting cartridge case of one or more medicinal tablets.
19. dispensing apparatus as claimed in claim 16 system further comprises patient's recognition device.
20. dispensing apparatus as claimed in claim 16 system, comprise that further the patient identifies reader, it is in fingerprint reader, optical retina reader, speech recognition system, RFID reader and the Wi-Fi system at least one that wherein said patient identifies reader.
21. dispensing apparatus as claimed in claim 16 system, wherein said granting end is configured to reduce the described dispensing apparatus of saliva inflow/enter.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310422020.3A CN103585021B (en) | 2006-01-06 | 2007-01-08 | Medicament storage and dispensing apparatus and comprise the system of this device |
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
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| US75693706P | 2006-01-06 | 2006-01-06 | |
| US60/756,937 | 2006-01-06 | ||
| US11/650,230 US8357114B2 (en) | 2006-01-06 | 2007-01-05 | Drug dispensing device with flexible push rod |
| US11/650,230 | 2007-01-05 | ||
| PCT/US2007/000527 WO2007081947A2 (en) | 2006-01-06 | 2007-01-08 | Drug storage and dispensing devices and systems comprising the same |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
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| CN201310422020.3A Division CN103585021B (en) | 2006-01-06 | 2007-01-08 | Medicament storage and dispensing apparatus and comprise the system of this device |
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| CN101495080A CN101495080A (en) | 2009-07-29 |
| CN101495080B true CN101495080B (en) | 2013-10-23 |
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| CN200780008097.9A Active CN101495080B (en) | 2006-01-06 | 2007-01-08 | Drug storage and dispensing devices and systems comprising same |
| CNA2007800046111A Pending CN101378732A (en) | 2006-01-06 | 2007-01-08 | Bioadhesive drug formulations for oral transmucosal delivery |
| CN200780007142.9A Active CN101394863B (en) | 2006-01-06 | 2007-01-08 | Small-volume oral transmucosal dosage forms |
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| CN201611042683.2A Active CN106727271B (en) | 2006-01-06 | 2007-01-08 | Small volume oral transmucosal dosage form |
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| CNA2007800046111A Pending CN101378732A (en) | 2006-01-06 | 2007-01-08 | Bioadhesive drug formulations for oral transmucosal delivery |
| CN200780007142.9A Active CN101394863B (en) | 2006-01-06 | 2007-01-08 | Small-volume oral transmucosal dosage forms |
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| CN (4) | CN106727271B (en) |
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Also Published As
| Publication number | Publication date |
|---|---|
| CN101394863A (en) | 2009-03-25 |
| CN101394863B (en) | 2016-12-21 |
| CN101378732A (en) | 2009-03-04 |
| CN101495080A (en) | 2009-07-29 |
| CN106727271B (en) | 2020-02-14 |
| CN106727271A (en) | 2017-05-31 |
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