Patent Publication Number: US-2011077614-A1

Title: Device and method for patient activated bolus administration

Description:
FIELD OF THE INVENTION 
     The device and method relate to a patient-activated administration of a quantity of therapeutic solution inserted to the body intravenously or subcutaneously. More specifically, the application relates to an improved device and method for the activation of a supplementary dose volume of medication to the dose of continuous flow controlled infusion therapy. 
     BACKGROUND OF THE INVENTION 
     Certain procedures or treatments, such as post-operative care, pain management, oncology, anti-biotic and other therapies call for a catheter to remain inside a patient body over an extended period of time at a continuous, designated rate or intermittently. Some therapies permit a patient to increase a flow or dosage at a particular time through the release of a increased volume of medication into the infusion administration. However, the therapy may nonetheless require that the total volume of the drug released into a subcutaneous channel remain constant over a designated period, such that a release of a greater volume at one or more points during an interval, be compensated by a release of smaller volumes at other points during the interval. In addition, some therapies set a maximum volume of a material that may be released by a patient action in a given period. For example, in some cases, once a patient triggers a release of an increased volume of an analgesic, there may be imposed a ‘lock out’ period during which the patient may not trigger a further release of the analgesic, or during which no further analgesic may flow into the intravenous channel. 
     Frequently, a doctor or practitioner sets a rate of a continuous flow of a medicine, and such medicine is introduced or pumped from a container by a pressure flow or other pump. A doctor may also want set a maximum volume or bolus that a patient can trigger, and a lock out period that may follow the bolus activation. The doctor may want to secure such setting against tampering by a patient. 
     BRIEF SUMMARY OF THE FIGURES 
     The subject matter regarded as the invention is particularly pointed out and distinctly claimed in the concluding portion of the specification. The invention, however, both as to organization and method of operation, together with features and advantages thereof, may best be understood by reference to the following detailed description when read with the accompanied drawings in which: 
       FIG. 1  is an exploded view of components of a device in accordance with an embodiment of the invention; 
       FIG. 2  is a diagram of a base component of a device in accordance with an embodiment of the invention; 
       FIGS. 3A ,  3 B,  3 C,  3 D and  3 E are diagrams of segments of the activator of a device in accordance with an embodiment of the invention; 
       FIG. 4  is a diagram of a reservoir with an inlet and an outlet in accordance with an embodiment of the invention; 
       FIGS. 5A ,  5 B and  5 C are diagrams of a cover of a device showing a locking pin holster in accordance with an embodiment of the invention; 
       FIG. 6A  shows a locking pin, and  FIGS. 6B and 6C  show the locking pin in a holster in an open and close position respectively, in accordance with an embodiment of the invention; 
       FIG. 7A and 7B  show a front of a device without a cover and with a button and without, respectively in accordance with an embodiment of the invention; 
       FIG. 8  is a diagram of a device in a see-through view, attached to a wrist band in accordance with an embodiment of the invention; 
       FIG. 9A  shows a device before a bolus volume setting has been selected and a security pin activated, and  FIG. 9B  shows a device after a bolus volume setting has been set and a security pin activated in accordance with an embodiment of the invention; and 
       FIG. 10  shows a drug administration system in which a device may be included in accordance with an embodiment of the invention. 
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
     In the following description, various embodiments of the invention will be described. For purposes of explanation, specific examples are set forth in order to provide a thorough understanding of at least one embodiment of the invention. However, it will also be apparent to one skilled in the art that other embodiments of the invention are not limited to the examples described herein. Furthermore, well-known features may be omitted or simplified in order not to obscure embodiments of the invention described herein. 
     As used herein, the terms “therapeutic agent,” “therapeutic material,” “active material,” “drug”, “medicine” and similar terms include in addition to their regular meanings, any therapeutic agent or active material, such as drugs, genetic materials, and biological materials. Suitable genetic materials include, but are not limited to, DNA or RNA, such as, without limitation, DNA/RNA encoding a useful protein, DNA/RNA intended to be inserted into a human body including viral vectors and non-viral vectors, and RNAi (RNA interfering sequences). Suitable viral vectors include, for example, adenoviruses, gutted adenoviruses, adeno-associated viruses, retroviruses, alpha viruses (Semliki Forest, Sindbis, etc.), lentiviruses, herpes simplex viruses, ex vivo modified and unmodified cells (e.g., stem cells, fibroblasts, myoblasts, satellite cells, pericytes, cardiomyocytes, skeletal myocytes, macrophage), replication competent viruses (e.g., ONYX-015), and hybrid vectors. Suitable non-viral vectors include, for example, artificial chromosomes and mini-chromosomes, plasmid DNA vectors (e.g., pCOR), cationic polymers (e.g., polyethyleneimine, polyethyleneimine (PEI)) graft copolymers (e.g., polyether-PEI and polyethylene oxide-PEI), neutral polymers PVP, SP1017 (SUPRATEK), lipids or lipoplexes, nanoparticles and microparticles with and without targeting sequences such as the protein transduction domain (PTD). Suitable biological materials include, but are not limited to, cells, yeasts, bacteria, proteins, peptides, cytokines, and hormones. Examples of suitable peptides and proteins include growth factors (e.g., FGF, FGF-1, FGF-2, VEGF, Endothelial Mitogenic Growth Factors, and epidermal growth factors, transforming growth factor .alpha. and .beta., platelet derived endothelial growth factor, platelet derived growth factor, tumor necrosis factor .alpha., hepatocyte growth factor and insulin-like growth factor), transcription factors, proteinkinases, CDK inhibitors, thymidine kinase, and bone morphogenic proteins (BMP&#39;s), such as BMP-2, BMP-3, BMP-4, BMP-5, BMP-6 (Vgr-1), BMP-7 (OP-1), BMP-8. BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15, and BMP-16. Currently preferred BMP&#39;s are BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, and BMP-7. These dimeric proteins can be provided as homodimers, heterodimers, or combinations thereof, alone or together with other molecules. Cells can be of human origin (autologous or allogeneic) or from an animal source (xenogeneic), genetically engineered, if desired, to deliver proteins of interest at a desired site. The delivery media can be formulated as needed to maintain cell function and viability. Cells include, for example, whole bone marrow, bone marrow derived mono-nuclear cells, progenitor cells (e.g., endothelial progentitor cells), stem cells (e.g., mesenchymal, hematopoietic, neuronal), pluripotent stem cells, fibroblasts, macrophage, and satellite cells. The term “therapeutic agent” and similar terms also includes non-genetic agents, such as: analgesics, anti-thrombogenic agents such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethylketone); anti-proliferative agents such as enoxaprin, angiopeptin, or monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid, amlodipine and doxazosin; anti-inflammatory agents such as glucocorticoids, betamethasone, dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine; antineoplastic/antiproliferative/anti-miotic agents such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, methotrexate, azathioprine, adriamycin and mutamycin; endostatin, angiostatin and thymidine kinase inhibitors, taxol and its analogs or derivatives; anesthetic agents such as lidocaine, bupivacaine, and ropivacaine; anti-coagulants such as D-Phe-Pro-Arg chloromethyl keton, an RGD peptide-containing compound, heparin, antithrombin compounds, platelet receptor antagonists, anti-thrombin antibodies, anti-platelet receptor antibodies, aspirin, dipyridamole, protamine, hirudin, prostaglandin inhibitors, platelet inhibitors and tick antiplatelet peptides; vascular cell growth promotors such as growth factors, Vascular Endothelial Growth Factors (VEGF, all types including VEGF-2), growth factor receptors, transcriptional activators, Insulin Growth Factor (IGF), Hepatocyte Growth Factor (HGF), and translational promotors; vascular cell growth inhibitors such as antiproliferative agents, growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies directed against growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin, bifunctional molecules consisting of an antibody and a cytotoxin; cholesterol-lowering agents, vasodilating agents, and agents which interfere with endogenous vasoactive mechanisms; anti-oxidants, such as probucol; antibiotic agents, such as penicillin, cefoxitin, oxacillin, tobranycin; angiogenic substances, such as acidic and basic fibrobrast growth factors, estrogen including estradiol (E2), estriol (E3) and 17-Beta Estradiol; and drugs for heart failure, such as digoxin, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors including captopril and enalopril. 
     In some embodiments, a medication or drug as used in this paper may include a medication that is suitable to be administered through infusion. 
     An intravenous or subcutaneous channel may, in addition to its regular meaning include a channel such as a tube for delivery of a mass, volume or bolus of therapeutic material into an intravenous, intra-dermal, intra-muscular or other channel into which medicines may be introduced or channeled into a body. 
     A bolus or volume may, in addition to its regular meaning, include a fluidic, semi-fluidic, suspended solid or solid of one or more therapeutic materials. 
     In some embodiments, a lock out period may be determined by a formula such as V/FR, where FR is a flow rate at the inlet tube of a device, and V is an effective volume of the reservoir of the device. Other ways to determine a lock out period are possible. 
     Reference is made to  FIG. 10 , a drug administration system in which a patient activated device may be included in accordance with an embodiment of the invention. In some embodiments, device  1000  may be part of or used with a drug administration system. The system may include a container or source of the drug being introduced into the system and a pump or other flow regulator by which a doctor or practitioner may set a flow of a drug from the container into a channel so that a set amount of the drug is introduced into the channel over a designated interval. The system may include one or more filters, device  1000  in accordance with an embodiment of the invention, one or more check valves and an exit port through which the drug enters a body area of a patient. In some embodiments, and absent patient activation of a pump or trigger in or connected with device  1000 , a drug may flow through the system and through device  1000  at a rate designated by a doctor or practitioner in the pump or flow regulator. In some embodiments, the activation by a patient of device  1000  may not increase the total amount of the drug introduced or delivered from the container into the system, but rather the amount or volume of the drug delivered at a particular moment and upon the activation of trigger or pump in or connected to device  1000 . In some embodiments, a drug may be supplied to device  1000  by a fixed flow rate restrictor or by a multi-flow rate flow regulator. 
     Reference is made to  FIG. 1 , an exploded view of components of a device in accordance with an embodiment of the invention, and to  FIG. 2 , a diagram of a base component of a device in accordance with an embodiment of the invention. Base  100  may be constructed of for example rigid plastic or other suitable material. A circular cylinder  103  may be positioned perpendicular to the bottom of base  100 . The inner hollow created by cylinder  103  may hold reservoir  300 . Openings  107  and  108  on cylinder  103  may accommodate reservoir inlet and exit tubes while pillar  105  serves as a clockwise stopper to the activator  400  and to prevent reservoir  300  from sliding out of cylinder  103 . Pillar  109  may serve as a counterclockwise stopper to activator  400 . Terraced cylinder  104  may be positioned concentrically to cylinder  103  at the inner circular edge of cylinder  103 . Cylinder  104  may be divided into several repeating and essentially similar segments, such as for example three segments, and such segments may include several steps  110  having width and height that are the same as the corresponding steps  110  in the other segments. Steps  110  on inner cylinder  104  may function as bottom stoppers to activator  400  such that upon activation, activator  400  may be depressed no further than the step  110  to which device  1000  is set. The number of steps  110  in the segments may be equal to the number of volume settings which device  1000  may expel in a single activation. Some embodiments may include six settings though other number of settings and volumes are possible. 
     In some embodiments, wrist belt  600  may be threaded through eyelets  101  to provide a patient with easy access to device  1000 , and so that device  1000  is portable with the patient. 
     Dents  106  may securely hold the inlet and exit tubes. Dents  106  may be matched with corresponding and opposite dents  204  (as appear in  FIG. 5B ) in cover  200  to surround inlet and outlet tubes from above and below. Hollow posts  102  may connect base  100  to cover  200  through compatible pins  205  as appear in  FIG. 5B . 
     Reference is made to  FIGS. 3A ,  3 B,  3 C,  3 D and  3 E, diagrams of segments of the activator of a device in accordance with an embodiment of the invention. Activator  400  may be constructed of one or more parts. Button  420  of activator  400  may include a return spring as an integrated part of button  420  or may include a spring, such as a coil or other spring, as a separate component. Button  420  may include segments or components such as button  401  that may include a marking to indicate a setting of device  1000 , a spring that made include two or more leaves  406 , external ring  405  and arm  402  to dial a volume setting for a dosage expelled by device  1000 . 
     In some embodiments, the activator may include two parts, such as a button  420  and stopper  430 . Such parts may be constructed of plastic or other suitable materials. Button  420  may include projection  403  at the upper face of arm  402  to secure and hold the selected volume setting. Dents  404  at the external circumference of ring  405  may facilitate a locking of a volume setting of device  1000  to prevent tampering or alteration of such setting by a patient or others, once the setting has been selected. Circular projection  408  at the lower external diameter of ring  405  may center the activator  400  over cylinder  103  of base  100 , allowing circular movement between the different volume settings. Three projections  407  of stopper  430  may prevent vertical movement of activator  400  and its corresponding compression of reservoir container  301 , when set over the suitable step  110  of cylinder  104 . Dents  409  and  410  on the bottom of button  420  and projections  411  and  412  on the top of stopper  430  may orient parts when assembled. 
     Reference is made to  FIG. 4 , a diagram of a reservoir with an inlet and an outlet in accordance with an embodiment of the invention. Reservoir  300  may include three parts, namely reservoir container  301 , inlet  302  and outlet  303 , though fewer or greater number of parts are possible. One or more of inlet  302  and outlet  303  may be equipped with one-way valves to avoid backflow. The reservoir can be “flexible” or “semi-rigid”. Flexible reservoir container  301  may be constructed of thin plastic sheets such as PVC, PU or PE. Other materials may be used. In some embodiments, reservoir container  301  may be semi-rigid and fashioned as a molded balloon of a suitable material. 
     Reference is made to  FIGS. 5A ,  5 B and  5 C, diagrams of a cover of a device showing a locking pin holster in accordance with an embodiment of the invention. Cover  200  may be constructed of rigid plastic or other suitable materials. 
     Central hole  206  may locate the central section of button  401  of activator  400 . Slot  201  may enable circular movement of arm  402  to select a volume setting. Dents  202  together with projection  403  may ease the positioning of activator  400  at the correct location when dialed to select the volume, and may secure it from further movement. Indicator  203  may indicate the possible volumetric or other settings for device  1000 . 
     Reference is made to  FIG. 6A , a locking pin, and  FIGS. 6B and 6C , a locking pin in a holster in an open and close position respectively, in accordance with an embodiment of the invention. Cylinder  208  and hole  207  may hold, protect and guide locking pin  500 . Locking pin  500  may be constructed of rigid plastic or other suitable material. In an un-locked position, pin  500  may be positioned on cover  200  so arm  501  is positioned over cylinder  208  while rod  503  may be positioned in hole  207 . 
     To permanently lock the selected volume, arm  501  may be turned 180° clockwise and then pushed down to a locked position. In such position the lower edge of rod  503  is positioned in one of dents  404 , dent  502  may be clicked into hole  207  to lock the setting. Other methods of locking a selected volume can be made so that no alteration of the selected volume are possible. In some embodiments, such permanent locking may require that device  1000  be disposable and suitable for only one use. 
     Reference is made to  FIG. 7A and 7B , a front a device with a without a cover in accordance with an embodiment of the invention. 
     Reference is made to  FIG. 8 , a diagram of a device in a see-through view, attached to a wrist band in accordance with an embodiment of the invention. 
     Reference is made to  FIG. 9A , a device before a volume setting has been selected and a security pin activated, and to  FIG. 9B , a device after a volume setting has been set and a security pin activated in accordance with an embodiment of the invention. 
     In some embodiments, volume settings may range from 0 ml. to 5 ml. with various steps such as 0.5 ml. or 1.5 ml. etc. Other settings, number of settings and volumes are possible. 
     In some embodiments, the device may be held or fastened other than on a user&#39;s wrist. 
     In operation, device  1000  may be linked to a container of a drug to be administered. A pressure pump or other device or force may release the drug into a line or channel to which device  1000  is connected. In some embodiments, reservoir  300  in device  1000  may be primed to be for example full of the drug being administered at the time that the connection to the patient is initiated or at some other time. A user such as a patient may activate or press a pump or release mechanism that may be included in or connected to device  1000  so that some or all of the contents of reservoir  300  are released by device  1000  further into the channel and into a body of the patient. The volume of medicine that may be released by the user&#39;s activation may be set in advance by a practitioner from among a choice of volumes. Once the user has activated the release of a drug from device  1000 , the reservoir may be emptied or at least partially emptied. The user will therefore not be able to release additional amounts of the drug into his body until the reservoir  300  refills at the rate provided by the pressure pump that is releasing the drug from the container. When the reservoir  300  is full, the device  1000  passes the drug along at the same rate as its release into the system from the container. 
     Device  1000  may include a security lock to prevent a user from altering a volume setting that may be released from the device in a single activation, once such setting has been selected by for example a practitioner. In some embodiments, once a volume setting has been made and locked, no further changes to such setting may be made. 
     In some embodiments, an inlet that may be connected to a reservoir of device  1000  may accept a flow of a drug at a pre-defined rate from for example a container of the drug and a pressure system or pump that may deliver the drug from the container to the reservoir  300 . In some embodiments, a separate pump or force-exertion device that may be connected to device  1000  may exert a force such as pressure upon.reservoir  300  of device  1000  to expel up to a maximum of a pre-designated volume of the drug from reservoir  300  to an outlet  303  channel of device  1000 . In some embodiments, the maximum pre-designated volume to be expelled from reservoir  300  upon activation of the force on reservoir  300  may be set in advance by for example a practitioner. In some embodiments, a tamper-prevention mechanism may disable a means to accept a maximum volume setting once such setting has been accepted so that a maximum volume setting can only be made once. 
     In some embodiments, once a volume of a drug has been expelled from reservoir  300  and delivered to an outlet  303  of device  1000  and into a channel leading to a body, reservoir  300  may refill at the pre-defined rate from the container, and further expelling of volumes of the drug may be limited by such rate of refilling, such that the total output of the drug from device  1000  over an extended period is equal to the pre-defined rate delivered from the container to reservoir  300  by way of the inlet. 
     In some embodiments, when reservoir  300  is full, and a force such as pressure is not exerted on reservoir  300 , the drug may flow from inlet  302  to outlet  303  at the predefined rate as is delivered from the container, so that a patient receives the drug at the pre-defined rate over the extended period after giving effect to, or after including the volume that may have been expelled when the force or pressure from for example the pump was activated. 
     In some embodiments, a device including reservoir  300 , a pump or pressure exerting component, an inlet  302 , an outlet  303 , and setting accepting mechanism may be housed in a single unit that may be worn or otherwise attached to a patient on for example a wrist band or with a clip to the patients finger, clothing or other body part, and the force exerting mechanism may be activated by the patient who is to receive the drug. 
     In some embodiments, the maximum volume that may be expelled from reservoir may be set from among several possible volume settings. 
     In some embodiments, accepting a setting of a maximum volume that is to be expelled from reservoir  300  may include limiting the maximum reduction in the volume of reservoir  300  that is caused by the force exerted on it. The setting on the restriction of the volume may be variable from among a fixed number of possible volumes or a continuous number of possible volumes. For example, if a setting of 2.5 ml is accepted, and reservoir  300  holds a maximum of 5 ml., then the setting mechanism may restrict the amount that the volume of reservoir  300  is reduced when the force is exerted upon it. In some embodiments, this may mean that the pump can only be depressed partially, so that the reservoir is only emptied half way. 
     In some embodiments, a volume of a drug may be introduced by the device only when for example a patient activates the force such as pressure on the reservoir. In such embodiments, a pressure-triggered valve of for example 3 atmospheres or some other pressure setting may be connected to outlet  313 , such that the outlet is opened only when a force such as pressure is activated on the device. When the force is not activated, the valve may be closed and the reservoir may fill until the next activation. In some embodiments, a mechanical force such as pressure that may be exerted manually by a patient on a button of the device may open the pressure valve and deliver a volume of drug. 
     It will be appreciated by persons skilled in the art that embodiments of the invention are not limited by what has been particularly shown and described hereinabove. Rather the scope of at least one embodiment of the invention is defined by the claims below.