DETAILED DESCRIPTIONDescribed herein are infusion systems and medicament loading systems. Methods for introducing or infusing medicaments and to provide proper channeling medicaments to patients are also disclosed herein that are useful for understanding the invention.
A drawback of multi-medicament (e.g., pharmaceutical, hormone, etc.) and certain single medicament regimens is that the patient or physician may accidentally load, transfer, and/or administer the incorrect medicament. For instance, a user may mistakenly believe that he or she is providing one medicament when they are accidentally supplying a different one. The accidental administration of the incorrect medicament to the patient can have serious and potentially fatal consequences. For example, standard-of-care insulin therapies for regulating blood glucose in diabetic patients may involve subcutaneous infusion of insulin via an insulin pump. If the amount of dosed insulin is excessive, it can lead to hypoglycemia or a situation of impending hypoglycemia. To combat and/or reverse such adverse situations, individuals typically consume additional carbohydrates (e.g. sweet juice or glucose tablets). In some situations, individuals can alternatively and/or additionally administer a so-called "rescue dose" of a counter-regulatory agent, such as glucagon. A counter-regulatory agent combats the effect of the excess medicinal dose (e.g., excess insulin) alleviating or substantially preventing adverse effects related to the excess dose. Glucagon can be reconstituted into solution from an emergency kit and manually administered intramuscularly. If a patient is given additional insulin instead of a rescue dose of glucagon, the results could be catastrophic, potentially leading to death. Similarly, during a diabetic episode, if a patient requires insulin but is given glucagon instead accidentally, that administration could exacerbate the episode and could lead to devastating effects and potentially death.
As illustrated above, the proper channeling in medicament dosing is critical where one medicament is used to achieve one effect while the other is used to achieve a different and/or the opposite effect (e.g., in the case of insulin and glucagon). In a multi-medicament automated system, if the medicaments are accidentally loaded in the incorrect reservoirs or incorrect chambers of a pump, the automated system could deliver an ineffective (and potentially harmful) medicament to the patient. This phenomenon of incorrect medicament administration in automated systems is called cross-channeling. Cross-channeling is dangerous because the wrong medicament could have the opposite of the intended effect or a side effect that is unanticipated. This improper channeling could not only fail to alleviate the patient's condition, but could make the patient's condition worse, or cause a new problem-state for the patient. For instance, this improper channeling could cause a negative feedback loop, wherein the control system attempts to adjust the patient's disease state in one direction, but the delivery of the incorrect medicament exacerbates or causes no effect on the disease state. Sensing this, the control system can trigger further doses of the wrong medicament in an attempt to control the patient's condition, while actually causing the patient's condition to further deteriorate (or causing overdosing of the incorrect medicament).
While diabetic drugs are used as an example above and elsewhere herein, improper channeling can have deleterious effects in many multi-medicament regimens (e.g., in drugs that regulate pancreatic enzymes, etc.) because a medicament is not administered to the patient at the necessary time or an incorrect medicament is administered at a dangerous level. Thus, the embodiments and considerations provided herein can be applied to any drug individually and/or any drug combination. Additionally, while cross-channeling can refer to systems where two medicaments are inserted into the incorrect chambers of a distribution system, the term cross-channeling as used herein can also refer to systems were more than two medicaments are used and/or where a single medicament is used (for example, when a single medicament is improperly placed in a distribution system).
Described herein are infusion systems for multiple medicaments and various connectors, tubes, and cartridges that ensure, help ensure, and/or substantially aid in providing proper channeling of each medicament to the patient. While certain embodiments, of infusion systems and components are described below to illustrate various examples that may be employed to achieve one or more desired improvements, these examples are only illustrative and not intended in any way to restrict the general inventions presented and the various aspects and features of these inventions. The phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. No features, structure, or step disclosed herein is essential or indispensable.
The infusion systems and components described herein are configured to minimize, lessen, and/or otherwise help avoid the occurrence of cross-channeling of medicaments. In other words, where multiple medicaments are supplied by the infusion systems disclosed herein, the features and/or components described herein are configured to prevent, minimize the occurrence of, or otherwise inhibit the opportunity for a user to inadvertently place a medicament in the incorrect reservoirs. One or more benefits of the infusion systems and components disclosed herein can be realized when a single medicament is used in the system. Additionally, the strategies described herein are also applicable to systems with single medicaments. In other words, as noted elsewhere herein, reference to systems that prevent "cross-channeling" also can include systems employing a single medicament. For example, the infusion systems disclosed herein provide a single medicament infusion system that, using the strategies and/or design features disclosed herein, ensure that only that single, appropriate medicament can be used and that inappropriate and/or incorrect medicaments cannot be used. Thus, the systems disclosed herein that avoid cross-channeling are intended to include single medicament systems that ensure proper placement (and/or channeling) of single medicaments.
Described herein is an infusion system for dosing multiple medicaments (or a single medicament) without cross-channeling. Cross-channeling is avoided by providing design features and/or mating connectors or adapters on certain components of the infusion system. For instance, the infusion system comprises an infusion pump with one, two, or more infusion chambers (or pump chambers), drive shafts. The system further comprises cartridges filled with different medicaments, and connectors and tubing that connect to the cartridge to the infusion pump in such a way as to prevent mischanneling or cross-channeling of medicaments. In certain variants, each type of cartridge for each type of medicament has one or more unique differentiating features (either as an integral part of the cartridge or as a component attached or affixed to the cartridge), for example geometric or shape-based features, that allow for unique coupling with a type of connector that itself has unique differentiating features that engage corresponding features in the pump housing and allow for insertion of the proper cartridge into the proper infusion chamber, drive shaft, or pump chamber within the infusion pump.
The system comprises an infusion set. The infusion set comprises a base with a housing having one or more implements (e.g., delivery members, needles, etc.) that allow delivery medicaments to the patient from the system. The housing is connected to a distribution set comprising one or more distribution connectors that are configured to receive a medicament from one or more medicament reservoirs (e.g., via a conduit etc.). One or more fluid conduits provide fluidic communication between the reservoirs and a distribution connector set. The connector set comprises one or more cartridge connectors that couple the fluid conduits to the medicament reservoirs. The reservoirs (or reservoir) are located in (and/or can be placed in) a pumping device configured to distribute the medicament from the reservoirs (or reservoir) to the conduit, thereby supplying the system with medicaments. The fluid conduits provide separate pathways that terminate at designated delivery members (e.g., needles, cannulas, etc.) within the base, thereby enabling independent delivery (e.g., subcutaneous or otherwise) of medicaments separately.
Unique mating connectors and design elements ensure that each portion of the system can only be connected within the system in a unique way or configuration, thus preventing the cross-channeling. The design features give rise to the following advantages: (1) the infusion system allows the user to easily connect and disconnect the channels independently from both medicament sources as well as from the infusion ports or sites; (2) the infusion system mitigates the possibility of mischanneling by accidentally connecting the wrong tubing to the wrong medicament source or infusion site (e.g., by having a connector that is disposed between one tube and one pump reservoir of one medicament system differ from the connector of the other tube and reservoir); and (3) the infusion system allows for a single or multistep insertion of the dual-cannula infusion site or port. The components described herein (connectors, bases, ports, channels, etc.) can further comprise visual or brail call-outs in addition to or instead of various paired physical features disclosed herein. For instance, the components can comprise call-outs with wording indicating a proper medicament. Different colors (red, blue, yellow, green, orange, violet, etc.) or lengths (or other variables) to provide visual feedback regarding appropriate medicaments for appropriate components.
As stated above, the infusion system is used to provide separate fluid pathways for a variety of medicaments (e.g., drugs, hormones, proteins, pharmaceuticals, biologics, etc.) dissolved in a variety of liquid carriers (and/or liquid drugs). Different liquid vehicles may be preferred based on the solubility, stability, or sensitivity of the medicament in a particular carrier. Aqueous solutions (buffers, etc.) are used as a delivery vehicle for the medicament. Solvents such as DMSO are used to dissolve medicaments. Solvent/aqueous mixtures are used.
Disclosed herein pertain to an infusion system for preventing mischanneling of medicaments and/or inadvertent administration of a medicament. The infusion system can be used for multiple medicaments or a single medicament. The infusion system comprises various needle sites, connectors, tubes, and/or cartridges. The infusion system and/or components thereof ensure proper channeling of each medicament to the patient. The infusion system comprises an infusion pump. The infusion pump comprises one, two, or more pump chambers. The infusion pump is configured to be used with pump cartridges. The cartridges can be filled at the point of care with different medicaments (or may be pre-filled with different medicaments, for example, at a pharmaceutical company). Different connectors and/or tubing connect the cartridges to the infusion pump in such a way as to prevent mischanneling and/or cross-channeling of medicaments. Each type of cartridge for each type of medicament has unique differentiating sizes, shapes, and/or geometrical features (either as an integral part of the cartridge or as a component attached or affixed to the cartridge) that allow for unique coupling with a type of connector. Each connector itself has unique differentiating features that engage corresponding features in the pump housing. Each connector only allows for insertion of the proper cartridge into the proper pump chamber within the infusion pump.
The medicament infusion system comprises an inlet system. The inlet system comprises a connector set. The connector set is configured (e.g., has pairing features) that prevent mischanneling of medicaments.Figures 1A-B show isometric views of a connector set 2000 comprising a first inlet connector 2010 (a needle connector) and a second inlet connector 2110 (a second needle connector) adapted to prevent mischanneling.Figures 1A-B show two embodiments in which different needle connectors 2010, 2110 (e.g., the inlet connector), have unique differentiating guiding elements 2018, 2118 (e.g., tabs, features, or protrusions), separated by 180 degrees (Figure 1A) and 120 degrees (Figure 1B). Adjacent guiding elements are separated by values independently selected from equal to or greater than: about 180°, about 160°, about 140°, about 120°, about 100°, about 90°, about 80°, about 70°, about 60°, about 50°, about 40°, about 30°, about 20°, about 10°, values between the aforementioned values or otherwise.
These unique differentiating guiding elements 2018, 2118 (e.g., tabs, features, or protrusions) mate uniquely with corresponding guiding element apertures 681, 682 (e.g., cavities, grooves, keyways, or slots) in the pump housing 680 of a pump 651 (as shown inFigures 3A-B) such that insertion of an inlet connector 2010, into the wrong pump receptacle 670 (e.g., chamber) is prevented. As shown inFigure 1C, a cross-sectional view of the needle connector assembly the inlet connector 2210 lacks unique differentiating tabs, features, or protrusions.
As shown inFigures 1A-B, the inlet connectors 2010, 2110 can have inlet connector spacers 2036, 2136 (e.g., relief slits). The connector spacers allow the inlet connector to expand (e.g., over a vial to snap tight around the vial or vial cap - e.g. an aluminum crimp) and/or to contract (e.g., to snap into a pump receptacle). The inlet connectors 2010, 2110 comprise projection mates 2066, 2166 (e.g., capture- and-locking features) to facilitate interaction with a medicament cartridge (shown inFigures 2A-C). The capture-and-locking features snap into place by engaging the underside of, for example, an aluminum crimp seal and simultaneously interlocking and securely fastening the needle connector with the aluminum crimp seal around the head (or crown) of the cartridge (e.g., vial). Once fastened, the cartridge and needle connector subassembly can then be inserted and fastened into a pump housing.
Where multiple relief slits are present, the relief slits can be spaced unevenly about the collar so that some projections are closer and some are farther. Adjacent relief slits are separated by values independently selected from greater than or equal to: about 180°, about 160°, about 140°, about 120°, about 100°, about 90°, about 80°, about 70°, about 60°, about 50°, about 40°, about 30°, about 20°, about 10°, values between the aforementioned values or otherwise. This inlet connector spacer allows the inlet connector to be compressed as it inserts into a pump housing or expanded as it is slid over a collar/reservoir assembly. This can allow snap tight fitting into a pump housing or with a collar/reservoir assembly that comprises mated features. For instance, once inserted all the way into the housing, the inlet connector spacers can re-expand, allowing the geometric features of the inlet connector to interact with mated apertures or features of the pump housing. This feature, among others described herein, can allow the reservoir to be held in an appropriate position, with little movement and/or substantially without movement, within the pump housing. The relief slits allow the inlet connector to be pressed over the head (or crown) of the cartridge. A locking mechanism snaps the inlet connector in place as it engages with the underside of the head (or crown) of the cartridge.
The needle connector has any number of unique differentiating tabs, features, protrusions, and/or combinations thereof, as inFigures 1-4, which would allow insertion into the pump chamber of a pump housing that contains corresponding cavities, grooves, keyways, or slots to match with the unique differentiating tabs, features, or protrusions on the needle connector. In this way, only one type of needle connector can be inserted uniquely into one particular pump chamber. Alternatively, the needle connector might contain any number of cavities, grooves, keyways, or slots (not shown) that uniquely mate with tabs, features, or protrusions in the pump chamber of a pump housing.
As shown inFigures 1A-C, tubing 301 is individually affixed (e.g., overmolded, bonded, press-fitted, glued, solvent bonded, insert molded, or otherwise attached) to individual inlet connectors 2010, 2110, 2210 (e.g., the needle connector). Tubing 301 (e.g., channels, or other fluid conduits) connects to separate piercing elements 316, 326, 336 (e.g., a straight, beveled, hollow, and/or stainless steel needles and/or catheters, etc.) in such a way as to allow a closed, independent, patent, and continuous fluid path from a medicament vial through piercing elements 316, 326, 336, inlet connectors 2010, 2110, 2210 and/or tubes 301 and on to an infusion set. The piercing elements 316, 326, 336 can be recessed within the inlet connectors 2010, 2110, 2210 so as to be touch-proof (e.g., preventing the piercing element from pricking a user as the inlet connector is manipulated). As shown inFigures 1A-C, the inlet systems comprise inlet connector covers 2030, 2130, 2230. The inlet connector covers 2030, 2130, 2230 engage the inlet connectors 2010, 2110, 2210 via a pairing projection 2012, 2112, 2212. The pairing projections comprise one or more features (e.g., tabs, slits, projections, etc.) and/or are sized enable covers to engage only with paired inlet connectors (not shown). As shown inFigures 1A-C, the inlet connector covers 2030, 2130, 2230 (e.g., caps) can comprise a tightening feature 2031, 2131, 2231 (e.g., threads, friction pairings, etc.) that allows them to be affixed into a pump receptacle. The connector cap/cover 2030, 2130, 2230 is freely rotatable around the tubing 301. The tubing passes through a threaded coaxial cap (e.g., the connector cover) such that the cap is free to slide up and down the tubing and to thread into a pump housing, as inFigures 3A and 3B. The cap 2030, 2130, 2230 can slide up and down the tubing 301 and can be used to secure the cartridge (e.g., vial, medicament reservoir) and needle connector (e.g., inlet connector) sub-assembly to a pump housing (shown inFigures 3A and 3B). The covers engage the pairing projection (by features or by friction). While engaged, the covers are still freely rotatable about the inlet connector. For example the pairing projection can comprise a circumferential track and the cover can comprise a circumferential protrusion that fits into the tract. The track holds the cover to the pairing projection, but allows free movement (e.g., allowing the cover to be screwed into the pump receptacle).
An inlet connector, such as the ones shown inFigures 1A-5C, has relief slits on the sides, which allow it to expand slightly as it is pressed over the aluminum crimp seal around the head (or crown) of a medicament-filled cartridge, and a capture-and-locking feature, which snaps into place by engaging the underside of the aluminum crimp seal and simultaneously interlocking and securely fastening the needle connector with the aluminum crimp seal around the head (or crown) of the cartridge. Once fastened, the cartridge and needle connector subassembly can then be inserted and fastened into a pump housing 680 (as inFigures 3A-B).
As shown inFigures 1A-B, the inlet connector system 2001, 2002 can comprise a gasket feature 2038, 2138 (e.g., an o-ring, or compressible feature) located around (e.g., around the periphery, external circumference, etc.) of an inlet connector cover 2030, 2130 or other inlet connector system feature. The o-ring allows the connector cap 2030, 2130 to be securely fastened to the pump 651 such that the medicament vials have little or no movement when inserted into the pump 651 via the receptacles 660, 670 and tightened there using the tightening features 2131, 2231. Even though the medicament receptacles can be isolated from the rest of the pump housing, the o-ring also reduces (e.g., minimizes, lowers, etc.) fluid ingress into the medicament receptacle such that consequent pump damage is minimized.
Figures 2A-C show various components and isometric views of (A) individual components that could be used in a cartridge and needle connector assembly, (B) the sub-assemblies that would be used in such an embodiment, and (C) the fully connected cartridge and needle connector assembly. To form the cartridge sub-assembly, a seal 536 (e.g., an aluminum crimp seal, etc.), wraps around the cartridge septum 534 and the head 532 (or crown) of the cartridge body 531. The seal 536 and septum 534 can be used to create a sterile barrier and fluid seal on one end of the medicament reservoir 530.
An elastomeric plunger 550 creates a sterile barrier and fluid seal on the other end of the cartridge 530. The elastomeric plunger 550 has a receptacle 552' that captures (e.g., through threading, friction, etc.) an insert 560 (e.g., a magnetic insert). As shown, the insert 560 (e.g., the ferrous insert) is threaded to correspond and engage paired threads on the plunger 550. The insert 560 could be used with a coupled piston (e.g., magnetically coupled) to prevent accidental medicament delivery caused by inadvertent separation of the piston from the elastomeric plunger 550. This insert which can comprise a magnetic material (e.g., a ferrous material and/or metal shavings, metal beads, metal powder, etc.) can facilitate magnetic coupling between a magnet at the end of the drive nut in a pump chamber and the elastomeric plunger such that it would prevent inadvertent departure or lift-off of the elastomeric plunger from the drive nut as in the case of unintentional medicament delivery caused by gravitationally induced changes in hydrostatic pressure between the patient and the infusion system, or any other changes in hydrostatic pressure that might arise between the patient and the infusion system. The ferrous insert could be connected to the elastomeric plunger by means of a snug-fit or snap-fit. The ferrous material comprises and/or is iron in the form of shavings, bead, powder, etc.
The inlet connector 2010 (i.e., needle connector) by virtue of its relief slits 2136 can expand around the head 532 (or crown) of the cartridge fitted with the crimp seal 536 allowing its capture-and-locking features/projection mate 2066 to snap into place by engaging the underside of the aluminum crimp seal 536 and simultaneously interlocking and securely fastening the inlet connector 2010 with the aluminum crimp seal 536. The cartridge and needle connector subassembly can be inserted into a pump housing and the threaded coaxial cap 2030 which is free to slide along the tubing 301, shown inFigure 2C, is used to fasten the sub-assembly to the pump housing, with the o-ring 2038 protecting the pump chamber from external fluid (shown inFigures 3A-B).
As discussed above,Figures 3A-B are an illustration of one type of pump housing 680 that could be used with medicament cartridges and the needle connector assemblies (shown inFigures 1A-2C) showing the reservoir and inlet connector sub-assemblies (inFigure 3A) partially loaded into the pump housing 680 and fully loaded into the pump housing 580 with the threaded coaxial caps 2030, 2130 completely screwed into the pump housing 580. The pump 651 has a display 652 that can provide digital feedback to the user regarding, for example, blood glucose levels, remaining medicament amounts, battery life, etc.
The fully assembled cartridge, needle connector, and tubing system (comprising a straight, beveled, hollow, stainless steel needle, a cartridge fastened to the needle connector with a capture-and-locking feature, tubing, and a threaded coaxial cap), inserts into a pump chamber of a pump housing that contains corresponding cavities, grooves, keyways, or slots to match the unique differentiating tabs, features, or protrusions on the needle connector (as shown inFigures 3A-3B). The threaded coaxial cap then screws into threads in the pump housing, as shown inFigures 3A and 3B.
The reservoirs can comprise a sticker, engraving, or label that comprises a readable code (e.g., a quick response code, matrix barcode, sku, barcode, image, other computer readable code, etc.). The pump 651 comprises a reader (e.g., an optical reader, scanner, etc., not shown) that reads the readable code when the reservoir is inserted into a pump chamber (e.g., a pump receptacle 660, 670). Where the code is recognized as being incorrect for a particular chamber or setting of the pump, the pump does not activate or stops operation (e.g., if the wrong code is present). Where the code is recognized as being incorrect for the current pump parameters (e.g., or amount of infusion per unit time, etc.), the pump is configured to automatically reconfigure to change the pump parameters to accommodate the actual medicament (e.g., cartridge) that is inserted. The pump provides an indication (e.g., audible, visual, haptic, vibrational, etc.) that alerts the user that the incorrect medicament is inserted. The user is then prompted to and/or is able to select a new setting for the pump to accommodate the new medicament (e.g., from a drop-down display on an LCD screen of the pump, etc.). Software and/or a computer application activates adjust the pump parameters to accommodate the medicament that has been inserted. For illustration, where the pump is configured to inject U100 insulin, but reads that U200 cartridge is inserted, the pump can change the delivery parameters to accommodate proper delivery of the U200 insulin from its reservoir. As another illustration, where the pump is configured to inject a rapid-acting insulin, but reads that ultrarapid-acting insulin cartridge is inserted, the pump can change the delivery parameters to accommodate proper delivery of the ultrarapid-acting insulin from its reservoir.
Figures 4A-B provide isometric views showing an embodiment with two cartridges and needle connector assemblies. As shown inFigures 4A-B, the first medicament reservoir 530 has a larger outer diameter (OD') and a larger inner diameter (ID') than the second medicament reservoir 570 outer diameter (OD") and inner diameter (ID"), respectively. The inlet connector 2310 has skirt features. When used with the smaller diameter cartridge 570, the inlet connector 2310 has skirt features 2320 that extend past the shoulder of the cartridge and hug the smaller diameter cartridge wall/body 571 closely. Accidental attempts to connect such an inlet connector 2310 with skirt features 2320 to a cartridge whose outer diameter is larger than that of the intended cartridge would be halted by the skirt features 2320 such that the capture-and-locking features (e.g., projection mate 2366) of the inlet connector 2310 would not be able to snap into place or engage the underside of the aluminum crimp seal 536 of the first medicament reservoir 530 (shown inFigures 2A-B) and the straight, beveled, hollow, stainless steel needle of the inlet connector 2310 (not shown) would not penetrate the cartridge septum 534 (shown inFigure 2A) of the larger diameter cartridge 530. In this way, mis-connection of a needle connector 2310 to a cartridge with a larger diameter than the intended cartridge is prevented (not shown). Furthermore, the pump housing can be designed such that the cartridge 530 with a larger diameter is unable to fit into the pump chamber/receptacle intended for the smaller diameter cartridge. The drive nut on the lead screw inside the pump chamber intended for the larger diameter cartridge cannot fit into the lumen of the smaller diameter cartridge 570 (not shown) because the internal diameter ID" is smaller than the drive nut. In this way, delivery of fluid when a cartridge is loaded into the wrong pump chamber is prevented.
The cartridge (e.g., cartridge A) containing one medicament (e.g., medicament A) has larger internal and external diameters than the corresponding diameters of the other cartridge (e.g., cartridge B) containing the other medicament (e.g., medicament B) (as shown inFigures 4A-B), such that cartridge A containing medicament A will not fit into the pump chamber intended for cartridge B containing medicament B, and the drive nut 2700 at the end of the lead screw 2701 (shown inFigures 6F-6G) in the pump chamber intended for medicament A is too large to fit into cartridge B containing medicament B.
The needle connector intended for cartridge B contains a skirt feature 2320 (as shown inFig. 4B) that prevents the needle connector intended for cartridge B from penetrating and/or capturing cartridge A if the needle connector intended for cartridge B is accidentally placed on cartridge A.
The diameter of the aluminum crimp seal around the crown of one cartridge is identical to that of the other cartridge, but the height of the aluminum crimp seal around the crown of cartridge B is greater than that of cartridge A, such that the capture-and-locking feature 2366 within the needle connector 2310 intended for cartridge A will not be engaged if the needle connector intended for cartridge A is accidentally placed on cartridge B (not shown).
As shown inFigures 1A-4B, the needle connector 2010, 2110, 2210, 2310 has any number of unique differentiating tabs, features, or protrusions, as shown in embodiments, which would allow insertion into the pump chamber of a pump housing that contains corresponding cavities, grooves, keyways, or slots to match with the unique differentiating tabs, features, or protrusions on the needle connector. In this way, only one type of needle connector can be inserted uniquely into one particular pump chamber. Alternatively, the needle connector might contain any number of cavities, grooves, keyways, or slots (not shown) that uniquely mate with tabs, features, or protrusions in the pump chamber of a pump housing.
Throughout this disclosure, similar features for separate embodiments of a device component (e.g., inlet connectors, inlet connector covers, etc.) can comprise one or more coinciding features offset numerically by a factors of 100 but having the same tens numerical value. For example, features of inlet connector 2030 that coincide to similar features of another connector 2130 will be offset by a 100, respectively (e.g., feature 2012 corresponds to 2112, etc.).
As shown inFigures 1A-4B, a straight, beveled, hollow, stainless steel needle is over- molded, bonded, press-fitted, glued, solvent bonded, insert molded, or otherwise attached to the inside of the needle connector 2010, 2110, 2210, 2310 and tubing 301 is overmolded, bonded, press-fitted, glued, solvent bonded, insert molded, or otherwise attached to the needle connector 2010, 2110, 2210, 2310 and to the straight, beveled, hollow, stainless steel needle in such a way as to allow a closed, independent, patent, and continuous fluid path through the straight, beveled, hollow, stainless steel needle, the needle connector, and the tubing. The straight, beveled, hollow, stainless steel needle is recessed within the needle connector 2010, 2110, 2210, 2310 so as to be touch-proof.
The tubing 301 passes through a threaded coaxial cap 2030, 2130, 2230, 2330, which is free to slide up and down the threaded coaxial cap and thread into a pump housing.
The fully assembled cartridge assembly, comprising a cartridge, needle connector, and tubing system (consisting of a straight, beveled, hollow, stainless steel needle, a cartridge fastened to the needle connector with a capture-and-locking feature, tubing, and a threaded coaxial cap, as shown inFigures 2A-4B), inserts into a pump chamber of a pump housing that contains corresponding cavities, grooves, keyways, or slots to match the unique differentiating tabs, features, or protrusions on the needle connector. The threaded coaxial cap then screws into threads in the pump housing, as shown inFigures 3A-B.
A medicament reservoir filling system and method of using the same is provided, as shown inFigures 5A-B. Figure 5A shows a rotated isometric view of a cartridge filling apparatus sub-assembly used to fill a medicament cartridge at the point of care.Figure 5B shows a fillable cartridge assembly after the filling apparatus has been connected.Figure 5C shows a fillable cartridge after the filling apparatus has been removed. As shown, a fillable cartridge body 530, would be supplied and pre-assembled with the cartridge septum 534 (shown inFigure 2A), the aluminum crimp seal 536 and the elastomeric plunger 550 with its threaded receptacle for a ferrous insert 552 exposed. A needle transfer hub 596 containing a single needle 595 (with two beveled tips or two needles, each with a single beveled tip) would be attached to its needle guard 594 and provided along with the fillable cartridge 530. A pushrod 590 would be attached to a threaded ferrous insert 561 by way of a breakable joint or threads and provided along with the fillable cartridge 530. At the point of care (or at a site where filling is appropriate), the pushrod 590 would be used to thread (via an attaching feature 561') the threaded ferrous insert 561 into the threaded receptacle for a ferrous insert 552 present within the elastomeric plunger 550. The needle transfer hub 596 would be then connected to the cartridge 530 such that the touch-proof needle or needle tip (not shown) within the needle transfer hub 596 would pierce the cartridge septum (shown inFigure 2A), after which the needle guard 594 would be removed to reveal the needle or needle tip 595 designed to pierce the septum of the vial. The needle or needle tip designed to pierce the septum of the vial would then be inserted into a medicament vial (not shown), and the pushrod 590 would be used to fill the cartridge body 530 with the medicament (e.g., by inserting the needle 595 into a bulk medicament and depressing the plunger 550 into and back out of the medicament reservoir 530). After filling the cartridge 530, the needle transfer hub 596 and the pushrod 590 would be removed, revealing the threaded receptacle for a pushrod, or breakable joint remnant, and leaving the threaded ferrous insert 561 embedded within the elastomeric plunger 550 by virtue of its thread-locking barb 561'. Such a cartridge that is filled at the point of care could then be attached to a needle connector assembly (as inFigures 2A-C) and loaded into a pump housing (as inFigures 3A-B).
Utilizing a needle transfer hub to transfer medicament from a vial to the cartridge, as inFigure 5, a straight, beveled, hollow, stainless steel needle is overmolded, bonded, press-fitted, glued, solvent bonded, insert molded, or otherwise attached to the needle transfer hub in such a way as to allow a closed, independent, patent, and continuous fluid path through the straight, beveled, hollow, stainless steel needle. The straight, beveled, hollow, stainless steel needle is beveled at both tips, where one tip would be designed to pierce the septum of the cartridge and the other tip would be designed to pierce the septum of the vial. The tip that is designed to pierce the septum of the cartridge is recessed within the needle transfer hub so as to be touch-proof and the tip that is designed to pierce the septum of the vial can be concealed and protected by a needle guard which would be removed at the point of care before piercing the septum of the vial.
Utilizing a needle transfer hub to transfer medicament from a vial to the cartridge, two separate, straight, beveled, hollow, stainless steel needles are overmolded, bonded, press-fitted, glued, solvent bonded, insert molded, or otherwise attached to the needle transfer hub in such a way as to allow a closed, independent, patent, and continuous fluid path through the straight, beveled, hollow, stainless steel needles. Each straight, beveled, hollow, stainless steel needle would be beveled only on one tip, where the beveled tip of one needle would be designed to pierce the septum of the cartridge and the beveled tip of the other needle would be designed to pierce the septum of the vial. The tip that is designed to pierce the septum of the cartridge is recessed within the needle transfer hub so as to be touch-proof and the tip that is designed to pierce the septum of the vial can be concealed and protected by a needle guard which is to be removed at the point of care before piercing the septum of the vial. Alternatively, the tip that is designed to pierce the septum of the vial can also be recessed so as to be touch-proof and a needle guard may not be supplied.
Mischanneling of medicaments can still be avoided if cartridge B is pre-filled with one medicament and cartridge A is filled at the point of care with a different medicament (using the embodiment described inFigures 5A-C). As long as only one cartridge needs to be filled with one medicament at the point of care, and the other cartridge is pre-filled with another medicament, the designs described here can prevent medicament mischanneling. Both cartridge A and cartridge B are pre-filled with medicament A and medicament B, respectively. Cartridge A is filled at the point of care with medicament A and cartridge B is pre-filled with medicament B.
The same dual-medicament infusion system could use identical needle sites, connectors, tubes, and cartridges in the configuration where both cartridge A is pre-filled with medicament A and cartridge B is pre-filled with medicament B, as in the configuration where cartridge A is filled at the point of care with medicament A and cartridge B is pre-filled with medicament B (or vice versa).
As inFigures 5A-C, one cartridge is filled at the point of care, medicament is transferred from a vial containing the medicament into the cartridge by way of a needle transfer hub and a pushrod that is connected to the elastomeric plunger residing in the cartridge by way of a breakable joint or threads such that the pushrod can be disconnected and discarded (or reused) upon completion of the filling procedure.
As inFigures 5A-C, involving a cartridge containing a ferrous insert, the pushrod can be connected directly to the ferrous insert by means of a breakable joint or threads. Upon completion of the filling procedure, the pushrod can be disconnected and discarded (or reused), leaving the ferrous insert embedded within the elastomeric plunger. In the case of a threaded connection between the ferrous insert and the pushrod, the threads on the ferrous insert could have a uni-directional burred surface (as inFigures 6A-F) that would allow it to easily thread into the elastomeric plunger, but would resist being threaded out of the elastomeric plunger. Whereas the threads on the pushrod would be smooth, and would not contain such a uni-directional burred surface (or other traction or frictional element), it would thread into and out of the ferrous insert easily, and without the ferrous insert threading out of the elastomeric plunger once the ferrous insert is fully threaded into the elastomeric plunger.
As shown inFigure 6A, a front view of the threaded ferrous insert 561, the insert 561 (e.g., ferrous insert) has a thread-locking barb 561'. An isometric view of the threaded ferrous insert 561 is shown inFigure 6B with a threaded receptacle for a pushrod 561" andFigure 6C shows an embodiment 560 without a threaded receptacle for a pushrod.Figure 6D is a front view of the snug-fit metal insert 563 showing a thread-locking barb 563'.Figure 6E is an isometric view of the snug-fit metal insert 563.Figure 6E shows a threaded receptacle 563" for a pushrod.Figure 6F shows an embodiment of a snug-fit insert 562 without a threaded receptacle for a pushrod. The ferrous insert that is used to facilitate magnetic coupling between a magnet at the end of the drive nut in a pump chamber and the elastomeric plunger could be attached to the elastomeric plunger by way of threads (as in A, B, and C) or by way of snug-fit or snap-fit (as in D, E, and F). Regardless of the method of attachment to the elastomeric plunger, the ferrous insert could have a threaded receptacle for a pushrod (as in B and E). In cases where a threaded receptacle for a pushrod is present, a pushrod could be pre-assembled with the ferrous insert. This subassembly could then be attached to the elastomeric plunger, either by way of threads, snug-fit, or snap-fit, and the pushrod could be used to fill an empty medicament cartridge. Upon filling the medicament cartridge, the pushrod could be detached from the ferrous insert while leaving the ferrous insert embedded within the elastomeric plunger (as inFigure 5C). The metal insert may have thread- locking barbs to prevent the metal insert from backing out or rotating with the pushrod as the latter is being removed.
As discussed elsewhere herein, a magnetic coupling between a magnet (or magnetic portion) at the end of the drive nut 2700 (located in a pump chamber of a pump) and the elastomeric plunger 550 occur to prevent inadvertent departure (or lift-off) of the elastomeric plunger 550 from the drive nut 2700. This coupling advantageously prevents the plunger from moving and distributing medicament in an uncontrolled and/or undesired way. For instance, medicament vials having plungers are typically designed to have little or no resistance and/or friction between the plunger and the wall of the reservoir. Thus, the plunger can move and distribute medicament with very little force applied to the plunger (e.g., even by moving the cartridge). Configurations described herein avoid issues with low friction plungers by coupling (e.g., magnetically) the plunger to the drive nut. As discussed elsewhere herein, a ferrous insert 565 can be screwed into the plunger 565 of the cartridge 530. A perceivable click (by touch, sound, etc., or other indication as described elsewhere herein) occurs when the magnetic tip of the drive nut and the magnetic insert come into contact. This click and/or mating can indicate to a user that the vial is properly placed in the pump.
Figures 6G-6H show a drive nut 2700 engaging with a medicament reservoir 530 via a magnetic tip 2702 of the drive nut. The drive nut 2700 comprises a lead screw 2701 that interacts with a driver in a pump (not pictured) to advance the drive nut forward, urging a plunger into the reservoir 530. As discussed elsewhere herein, a magnetic insert can be placed in the plunger of the reservoir (e.g. screwed-in). A frictional element (e.g., by a barb, etc.) can affix the insert in the plunger (so that the insert will not back-thread out of the plunger, for example). As described above, the magnetic insert 565 could be connected to the elastomeric plunger 550 by means of a snug-fit, snap-fit, and/or with a barb. The tip of the drive nut comprises a magnetic material (e.g., a ferrous metal) and the insert comprises a magnet. A configuration of a magnetic insert 565 inserted into a plunger 550 that is in magnetic communication with a magnetic tip 2702 of a drive bolt 2700 is shown inFigures 6H-6I.
The magnetic insert 565 (e.g., ferrous insert) can be injection-molded and/or can comprise, in part, a curable material that is cured during fabrication. During fabrication of the magnetic insert 565, a curable material (e.g. uncured plastic, rubber, elastomer, polymer, epoxy, composite, etc.) is mixed with a magnetic material (e.g., a ferrous material, metal shavings, metal beads, metal powder, etc.). During mixing, the magnetic material can be distributed homogeneously and/or as a gradient throughout the curable material. The curable material can then be cured to provide a magnetic insert 565 with magnetic material distributed within the cured material.
By using a polymeric insert (e.g., plastic, rubber, elastomer, composite, etc.) that is loaded with magnetic material (e.g., a ferrous material, metal shavings, metal beads, metal powder, etc.), a desired strength of association between the magnetic tip 2702 and the magnetic insert 565 can be achieved. A tailored magnetic coupling between the insert 565 and the magnet 2703 at the magnetic tip 2702 of the drive nut 2700 (as shown inFigures 6G-6K) can be achieved by adjusting the concentration of magnetic material in the insert 565 and/or by adjusting the size and/or strength of the magnet 2703. The magnetic interaction can be of sufficient strength such that the magnetic coupling would avoid inadvertent departure, separation, or lift-off of the plunger 550 from the drive nut 2700 thereby decreasing the threat of unintentional medicament delivery. The magnetic properties of the tip and the magnetic material of the plunger (or insert) can be tailored so that they are strong enough to associate with one another, but not so strong that the magnetic material interacts with objects outside the pump (e.g., objects other than the magnetic tip 2702 and the drive nut 2700).
The magnetic material can be directly dispersed within the plunger 550 during fabrication of the plunger. For example, during fabrication of the plunger, magnetic properties can be added to the plunger material prior to and/or during molding. This obviates the need for insert 565 having magnetic properties. This advantageously simplifies the system and avoids additional steps needed for coupling an insert to a plunger.
Using an insert with magnetic properties that is placed within plunger advantageously prevents contact between the medicament in the reservoir and the magnetic material. Using an insert 565 with magnetic properties in the plunger 550 (instead of a magnetic material distributed in the plunger) advantageously prevents leaching of the magnetic material into the medicament by preventing contact between the magnetic material and the medicament. Using an insert configuration also improves the integrity of the reservoir. For example, when the reservoir is filled by a patient or at the point of care, the plunger is depressed and retracted multiple times. When distributed directly in the plunger, the magnetic material abrades the inner chamber of the vial after multiple uses. This abrasion can lead to premature failure of the vial and/or leaking of the reservoir assembly. Using the insert with magnetic properties in the plunger avoids this abrasion. An insert having magnetic properties can be an integral, but separate, component embedded within the elastomer plunger such that there would be no need to manually insert it into the plunger at the point of care (i.e. the plunger would come with the insert already installed by the manufacturer during the fabrication of the plunger/insert assembly).
Figures 6I-6J show a bisected view of the drive nut 2700 engaging an insert having magnetic properties 565 via the tip 2702 of the drive nut 2700. As shown, the tip 2702 can comprise a magnet 2703 that interacts and/or connects to the insert having magnetic properties 565 of the plunger 550 within the reservoir 530.Figure 6K shows a partially bisected view of the drive nut 2700 engaging an insert having magnetic properties 565 via the tip 2702 of the drive nut 2700. InFigure 6K, the tip 2702 is not bisected, nor is the insert having magnetic properties 565. As shown the tip 2702 can include a protrusion 2702' (e.g., a handle, spike, projection, etc.) that inserts into the drive nut 2700 to hold the tip 2702 in place.Figure 6L shows the drive nut assembly, including the drive nut 2700 and the lead screw 2701 and the tip 2702 removed from the pump housing.
Figure 6M shows another partially bisected view. InFigure 6M, the insert having magnetic properties 565 in the plunger 550 is shown in the reservoir 530. As shown, similar to the insert shown inFigure 6B, the insert 565 can comprise an aperture 566 (e.g., a connector, a hole, a fixing point, locking mechanism, etc.) that allows engagement of a push rod (not shown). As described elsewhere herein, at the point of care (or at a site where filling is appropriate), the pushrod 590 would be used to thread (via a receptacle for a pushrod 566) the threaded insert having magnetic properties 565 into the threaded receptacle for an insert present within the elastomeric plunger 550.Figure 6N is a view of the magnetic tip 2702 in magnetic contact with the insert having magnetic properties 565. The aperture 566 is also shown. The pushrod 566 can be used to install the insert 565 into the plunger 550.
A method of detecting and continuously monitoring contact between the elastomeric plunger or insert 565 and the drive nut 2700 in each pump chamber is provided. For instance, the insert 565 (or plunger) is made of electrically conductive plastic (e.g., a plastic containing carbon fibers, metal strands, shavings, copper filings, etc.) and it serves as a conducting element that can complete a passive electrical circuit. Mating components of the passive circuit could be installed on the tip 2702 of the drive nut 2700 in each pump chamber. The passive electrical circuit on the tip 2702 of the drive nut 2700 could be powered remotely by an active circuit installed somewhere within the pump housing (e.g. using some form of radiofrequency identification or "RFID" such as a near-field communication protocol). In the absence of the electrically conductive insert 565 (or plunger), current would not flow through the passive electrical circuit on the tip 2702 of the drive nut 2700. Contact between the electrically conductive insert 565 (or plunger) and the passive electrical circuit on the tip 2702 of the drive nut 2700 would close the passive circuit and allow current to flow through the passive circuit and through the electrically conductive insert 565 (or plunger).
The change in status from a no-current-flow state to a current-flow state would correspond to a change in status from a no-contact to a contact configuration between the electrically conductive insert 565 (or plunger) and the tip 2702 of the drive nut 2700. If a drug cartridge is placed into the pump chamber and the insert 565 is not present, this detection mechanism could place the pump into a fault state. The fault state could prevent the pump from operating (preventing medicament flow). The fault state triggers an alarm feature that could alert the user of the error (e.g., a vibration, audible alarm, visual alarm, etc.). If the elastomeric plunger 565 lifts off of the drive nut 2700 during operation, this detection mechanism could also place the pump into a fault state, and an alarm could alert the user of the error.
The elastomeric plunger insert 550 (shown inFigures 6I-6J) could be made of an electrically conductive material having magnetic properties (such as an electrically conductive plastic loaded with ferrous material). If a passive electrical circuit were installed on top of a magnet 2702 located at the tip of the drive nut 2700, then an active circuit (installed somewhere within the pump housing) could communicate (e.g., through RFID) to remotely power the passive circuit and detect whether or not there is contact between the elastomeric plunger 550 (and/or the insert 565) and the tip 2702 of the drive nut 2700. At the same time, the magnet could be used to capture the insert and elastomeric plunger assembly (as described previously). In this way, the same insert could simultaneously serve as an integral component of the elastomeric plunger capture mechanism and the elastomeric plunger detection mechanism described previously. This embodiment is shown schematically inFigure 6O. The infusion system can comprise one or more of a pump with a drive nut having a tip 2805 that interacts with a plunger 2806 of a reservoir 2810. As the tip of the drive nut 2805 engages and pushes the plunger 2806, it advances the plunger 2806 into the reservoir 2810 which distributes a medicament via a needle connector 2815 into a fluid conduit 2820 to an infusion connector 2825 that connects to an infusion base 2830. The infusion base 2830, as discussed elsewhere herein, can distribute the medicament into a patient (e.g., through a needle or catheter). As shown in the schematic ofFigure 6O, the components of the electric circuit 2807 can be separate from the magnetic insert 2808 in the plunger 2806.
As an alternative configuration and as shown inFigure 6P, a passive electrical circuit could be embedded in the insert (rather than on the tip of the drive nut 2700). The passive electrical circuit also has magnetic properties and the magnet on tip 2702 of the drive nut 2700 could be electrically conductive. In this way, contact between the passive electrical circuit embedded in the insert and the electrically conductive magnet on the tip 2702 of the drive nut 2700 would close the passive circuit and allow current to flow through the passive circuit and through the electrically conductive magnet, thereby changing the status from a no-contact to a contact configuration between the passive electrical circuit embedded in the insert and the head of the electrically conductive magnet located at the tip 2702 of the drive nut 2700.
Additionally, the electric circuit configuration can allow users to avoid inserting incorrect cartridges (e.g., medicament vials) into the pump and using them with the infusion system. For example, if a user attempts to insert a vial having medicament reservoir with the incorrect plunger into the pump (e.g., a reservoir lacking a magnetic and/or conductive insert), the pump remains in the no-contact mode and does not distribute the medicament. This feature can also act as a safe guard to ensure that only proper vials are used in appropriate ports of the pump (avoiding mischanneling, etc.). This feature can help avoid distribution of the incorrect medicament to a patient.
An alternative and/or additional method for detecting the presence of the plunger of a cartridge (and/or the presence of a cartridge itself), is to initiate a detection sequence before attempting to administer a dose. For example, the detection sequence can involve applying a limited driving electrical current. The limited driving electrical current could be one that is just sufficient to advance the drive nut when not in contact with a cartridge plunger. In other words, the limited driving electrical current could be one that is insufficient to advance the drive nut when in contact with the cartridge plunger. For example, where the plunger is present, it has sufficient static friction and/or flow resistance downstream (whether due to friction within the cartridge body, neck, connector, or connected tubing, and/or from added features within these components, such as a check valve, etc.) and resists and/or substantially prevents the advancement of the drive nut. Once the plunger is detected, the electrical current can detectably ramp up and/or enter a delivery mode (where the pump is configured to distribute medicament into the patient). This detection process could be repeated just in advance of each medicament dosing attempt to ascertain whether or not the plunger (and/or an appropriate plunger) and/or insert is present and/or in contact with the drive nut. Then, depending on whether the plunger and/or insert is detected or not, the pump could respond accordingly (e.g. by dosing if plunger is detected, or by aborting the dose and/or annunciating an alarm if plunger is not detected to be present). The detection sequence and the control of the electrical current described above can be implemented using a controller. The controller is described more in detail elsewhere herein.
The detection sequence involves a probing sequence. The probing sequence involves the advancement of the drive nut, as described elsewhere herein, to first detect the plunger. Once the plunger is detected, the type of plunger can be determined by retracting and advancing the drive nut incrementally until a force and/or current sufficient to just move the plunger is reached. For example, plungers for varying reservoirs for different medicaments can have different resistance (e.g. frictional and/or due to resistance offered by other reservoir and/or connector components that correspond to that specific reservoir and medicament) to movement by the drive nut. Based on the level of resistance, through the amount of electrical current required to advance the plunger, the type of medicament can be detected. For illustration, the drive nut is advanced until it detects the plunger. Once the plunger is detected, the drive nut can either be retracted and/or advanced short distances (e.g., tapping of the plunger) until a sufficient force and/or current is generated and/or applied to move the plunger or its pushing against the plunger can be gradually increased (i.e. driving current escalated, without first retracting the plunger) until a sufficient force and/or current is generated and/or applied to move the plunger. Based on the force (in turn the corresponding required electrical current draw) required to move the plunger, the type of medicament in the pump receptacle can be detected. As an exemplary demonstration, four different medicaments can be provided in four different reservoirs with plungers that move in response to four different levels of force applied to the plungers (and/or current applied to the drive nut). The first medicament reservoir plunger can move in response to a lowest applied force and/or current, the second medicament reservoir plunger can move in response to a second slightly higher applied force and/or current, the third medicament reservoir plunger can move in response to a third slightly higher applied force and/or current, and the fourth medicament reservoir plunger can move in response to a fourth and highest applied force and/or current. If the third medicament reservoir is placed in the pump, the drive nut can probe the amount of force and/or current required to move the plunger with tapping (e.g., successive advancement and retraction of the drive nut) or by gradual escalation of the force and/or current as the drive nut remains in contact with the plunger (without retraction). The first, second, and fourth medicaments can be eliminated as potential medicaments in the pump by virtue of the plunger moving in response to a force/current corresponding to that required to move the plunger of the third medicament reservoir. In other words, the controller and drive nut can be configured to tap/push with the lowest force, escalate to a different force/current, and move to the next force/current until the proper amount of applied force/current is determined.
One or more of the medicament reservoir detection methods described elsewhere herein can be used in combination with the detection sequences and/or probing sequences described here to determine the type of medicament in the reservoir receptacle of the pump (e.g., an optical code reader, RFID, etc.). One or more of the medicament reservoir differentiation methods described elsewhere herein (e.g., an optical code reader, RFID, etc.) can be used in combination with the detection method described here to determine the type of medicament in the reservoir receptacle of the pump.
In addition to or instead of one or more features of the plunger inserts described elsewhere herein, a plunger insert may also include features that give them identifiable electrical impedances (or electronic properties). An insert's electrical impedance (controlled by the amount of conducting material placed into the insert, for example, during the manufacturing process) can be set and used as a unique identifier of the specific drug and/or of a specific drug property of a specific drug contained in a cartridge that includes that plunger insert. For example, a variety of plunger inserts could be fabricated with different impedance levels and each impedance level could be matched with a different drug or drug property (or set of properties) of the same drug (e.g. at a different concentration, pH, excipient content, or other properties, etc.). To illustrate, a first drug could be provided in a first cartridge having a plunger with a first electrical impedance. A second drug, alternatively could be provided in a second cartridge having a second plunger with a second electrical impedance (the second electrical impedance being different from the first). Additionally, a third medicament cartridge could be provided containing the second drug at a different concentration than in the second cartridge. The third cartridge would have a third electrical impedance that is different from the first and second impedances, making each cartridge distinguishable from the next. For a given voltage applied to the insert, a unique electrical current would arise for a particular plunger insert's impedance. A particular electrical current can then be linked to a specific drug and/or specific drug property (or set of properties) contained in the cartridge. These particular impedances could be mixed and matched with other features disclosed herein to give various different receptacles that avoid cross-channeling.
Where electrical impedance is used as an identifier for a particular drug or drug property, the matching keyset that associates each plunger insert's resultant electrical current with its corresponding drug could then be loaded into the infusion pump's software, such that the infusion pump is able to automatically identify the specific drug that is resident in the cartridge once it is loaded into the infusion pump. With this method, the pump can autonomously distinguish among the drugs and/or their properties and/or could self-initialize its dosing settings accordingly, without requiring or being vulnerable to user input. Independently from this electrical impedance feature, the various plunger inserts could additionally or alternatively have different distinguishing features (as described elsewhere herein) so that each uniquely mates with matching features in the cavity of its corresponding plunger, so as to match different inserts that have different impedance levels with different plungers.
A magnetic insert can be installed in the plunger. The polarities of the magnetic insert and the magnet in the drive nut can be oriented to attract one another (e.g., north and south) or to repel one another (e.g., so their polarities are repulsive; e.g., south/south or north/north). The magnetic insert of a medicament vial is oriented to only attract and couple to the magnet of a drive nut in the correct medicament pump aperture. Alternatively, when inserted into the incorrect medicament pump chamber, the magnetic insert repels the magnet of the drive nut. Thus, the incorrect medicament vial cannot be placed in the wrong chamber. Additionally, the electric circuit (where present) cannot be completed, thereby preventing infusion of the medicament. These configurations prevent medicament misplacement and prevent infusion of the incorrect medicament.
Where two medicaments are to be provided using the infusion system, mischanneling can be avoided by orienting the magnetic inserts to repel incorrect medicament reservoirs and to attract only the correct medicament reservoirs. For example, a magnetic insert of the first medicament reservoir can be oriented such that it repels a magnetic tip of the drive nut in the second medicament pump cartridge aperture (e.g., chamber). Additionally, a magnetic insert of the second medicament reservoir can be oriented such that it repels a magnetic tip of the drive nut in the first medicament pump cartridge aperture (e.g., chamber). By avoiding insertion into the wrong chamber of the pump, the patient reduces the risk of infusing the incorrect medicament
As described elsewhere herein, during fabrication of a magnetic insert 565, a curable material (e.g. uncured plastic, rubber, elastomer, polymer, epoxy, composite, etc.) is mixed with magnetic filings. During mixing, the magnetic filings can be magnetically aligned using an external magnetic dipole so that a magnetic pole is formed in the curable material. The curable material can then be cured to provide a magnetic insert 565 having a magnetic north and a south pole distributed within the cured material. This cured insert repels the magnetic drive nut in the incorrect pump chamber and attracts the drive nut in the correct pump chamber.
The magnetic insert can be configured (e.g., shaped, etc.) to only interact with an appropriate, pre-selected cartridge plunger (e.g., having coinciding, pairing features). For example, when two cartridges (A and B) are both filled at a point of care, the magnets of the magnetic insert for A and the magnetic insert for B can be configured to only insert into a plunger cartridge for medicament A and a plunger cartridge for medicament B, respectively. The plunger of cartridge A and the plunger of cartridge B can have one or more differentiating features that prevent engaging the incorrect magnet insert. For illustration, magnetic insert A can have features (e.g., threads, clips, clamps, etc.) that coincide to mating features on plunger A and not plunger B. Magnetic insert B can have features (e.g., threads, clips, clamps, etc.) that coincide to mating features on plunger B and not plunger A. One pair (the plunger and insert) can be threaded in the forward direction and the other pair in the reverse direction. These differentiated magnetic inserts ensure that magnets are inserted correctly to attract a correct magnetic tip of a drive nut (in a correct pump chamber) and to repel an incorrect magnetic tip of a drive nut (in an incorrect pump chamber).
As another measure to prevent inadvertent separation or lift-off of the elastomeric plunger 550 from the drive nut 2700 (as an additional or alternative measure), a check valve 2800 can be added to the fluid path within the cartridge or downstream of the cartridge. The check valve 2800 allows fluid flow passed the check valve 2800 only if a sufficiently high pressure gradient were to exist (e.g., pressure supplied by the pump turning the lead screw and urging the plunger forward). As shown inFigures 6Q-6T, the check valve 2800 comprises a membrane 2801 (e.g., a septum, a diaphragm, etc.) that deforms under pressure to allow fluid passed it. Other check valve types can be used (e.g., ball check valves, swing check valves, tilting check valves, clapper valves, stop-check valves, lift-check valves, duckbill valves, etc.).
The membrane 2801 is flexible. The membrane 2801 is also resilient. The membrane 2801 is rubber, plastic, polymeric, elastomeric, combinations thereof, or the like. When the plunger is not urged forward, the membrane 2801 rebounds to its original shape and prevents fluid from traveling through the needle 316 and into the tubing 301.
The check valve comprises an opener feature 2802 against which the diaphragm 2801 presses when pressure mounts on the diaphragm 2801 from fluid being urged from the reservoir 530. When the pressure is sufficient, the diaphragm 2801 deforms against the opener feature 2802 (e.g., a peg, spike, conical member, triangular member, etc.) to allow fluid (e.g., a medicament) to pass the diaphragm and escape via the tubing 301. As shown inFigure 6T, the opener feature 2802 is part of the pairing projection 2804 of the inlet connector. The opening feature 2802 is connected to the pairing projection 2804 via a stem 2803 (e.g., an arm, etc.). The inlet connector, opening feature, and stem are one continuous piece (e.g., injection molded together). One or more of the inlet connector, opening feature, and stem can be different pieces that are connected or bonded together after fabrication of the individual parts.
The check valve allows fluid to pass only after reaching a threshold pressure (e.g., a crack pressure). The threshold pressure needed to allow fluid flow passed the check valve is greater than any gravitationally induced hydrostatic pressure differential that might develop between the patient and the infusion system. For instance, hydrostatic pressure can develop when the infusion system is connected to a patient via the infusion base and the patient (or user) lifts the loaded pump (containing one or more medicament vial(s)) to an elevation over the infusion base. By force of gravity, the elevation of the vial pushes fluid from the vial through the conduit and into the patient via the infusion base set. The amount of hydrostatic force applied is determined by the elevation of the medicament vial over the infusion set. The amount of hydrostatic force, therefore, is usually limited by the length of the fluid conduit (which ultimately connects the medicament vial to the infusion set). A standard length of the fluid conduit is about 110 cm or about 60 cm. The check valve is sufficiently resilient to remain closed when a vial of medicament in the infusion system is elevated over the infusion set by a distance of at least: about 220 cm, about 110 cm, about 60 cm, values between the aforementioned values, or ranges spanning those values. The check valve is designed such that the threshold pressure gradient needed to allow fluid flow passed the check valve is greater than any hydrostatic pressure differential that might arise due to any other changes in the hydrostatic pressure between the patient and the infusion system (e.g., force caused by an airplane changing elevation, a carnival ride, bungee jumping, physical activity, etc.).
As shown inFigures 6Q-6T, the check valve is integrated into the needle connector (e.g., inlet connector) that couple to and capture the cartridges containing the medicaments. Alternatively, the check valve could be integrated anywhere along the length of the tubing 301, into the infusion site base, the infusion site connectors, or elsewhere in the infusion system. For instance, as shown inFigure 6U, the resisting feature 2835 (e.g., the check valve or a similar back flow stopper), can be positioned between the reservoir 2810 and the needle connector 2815 (e.g., in the needle). As shown inFigure 6V, the resisting feature 2835 can be located in the needle connector 2815. As shown inFigure 6W, the resisting feature 2835 can be located in the along the fluid conduit 2820. As shown inFigure 6X, the resisting feature 2835 can be located in the infusion connector 2825. As shown inFigure 6Y, the resisting feature 2835 can be located in the infusion base 2835. As shown inFigure 6Z, the resisting feature 2835 can be located anywhere in the infusion system between the patient 2840 and the reservoir 2810.
A transient connection between the plunger and drive nut is provided. The connection between the plunger and drive nut does not require and/or does not comprise a magnet and/or a ferrous insert. The connection between the plunger and drive nut uses one or more features on the tip of the drive nut that connects to (e.g., couples with, fits inside, envelopes, engages, fixes to, etc.) the plunger and/or retains the plunger. The connection between the plunger and drive nut is a physical connection (e.g,. accomplished with threading, a snug-fit connection, a snap-fit connection, and/or a barbed connection) and is not magnetic.
An optical sensor detects the presence of a medicament reservoir. The optical sensor detects, for example, the proximity of the plunger to the drive nut. The optical sensor detects a feature of the plunger (e.g., shape, color, etc. of the insert or plunger). The optical sensor is in electronic communication with a software module that determines when/if there is contact with the plunger and/or that the correct plunger is being used (e.g., the correct plunger within the reservoir). Once receiving input from the optical sensor and determining if the proper reservoir is inserted, the pump activates (when the proper medicament is inserted) or deactivates (when the improper medicament is inserted). As disclosed elsewhere herein, once an improper medicament is detected, the pump can automatically reconfigure to provide the correct dosing regimen of the inserted medication. Once an improper medicament is detected, the pump or a display on the pump can indicate to the user that the improper medicament has been placed in the pump. The user can manually reconfigure the pump to provide the correct dosing regimen of the inserted medication.
The drive nut comprises a mechanical switch (e.g., on the tip of the drive nut) that can be activated (e.g., depressed, displaced, moved, etc.) when it contacts a plunger. The mechanical switch is configured to only be activated by appropriate medicament reservoirs (e.g., because incorrect reservoirs are not shaped appropriately to depress the switch). For example, switch is located at the center of the drive nut and a non-matching (e.g., incorrect) medicament reservoir comprises a hood or sash that elevates the plunger of the medicament reservoir over the switch such that the switch is not depressed as the drive nut contacts the reservoir. The switch can be located on the plunger and can be activated by the drive nut. The pump (e.g., an optical sensor in the pump, receiver, etc.) is configured to detect when the switch of the plunger is actuated.
The drive nut comprises a capacitive proximity sensor. The capacitive proximity sensor is positioned on the tip of the drive nut. The capacitive proximity sensor detects when the plunger is in proximity with and/or is contacted by the drive nut. The capacitive proximity sensor indicates and/or detects when the drive nut and plunger are in close proximity and/or are substantially in contact with each other. The capacitive proximity sensor detects when the plunger and the drive nut are separated by a distance of less than or equal to about: 2 mm, 1 mm, 0.5 mm, 0.1 mm, or ranges including and/or spanning the aforementioned values. When a cartridge is inserted and the proximity sensor does not detect the plunger (e.g., because one or more features on the cartridge, the plunger, and/or drive nut prevent the proximity sensor from coming into close enough proximity to the plunger to detect it), an indication is provided to the user (e.g., an alarm that is audible, visual, haptic, vibrational, etc.). When a cartridge is inserted and the proximity sensor does not detect the plunger (e.g., because one or more features on the cartridge, the plunger, and/or drive nut prevent the proximity sensor from coming into close enough proximity to the plunger to detect it), the pump automatically retracts the drive nut away from the cartridge. Once the drive nut is retracted, the pump will not allow the drive nut to traverse forward until a new cartridge is placed in the pump chamber. When the proximity sensor detects the plunger, an indication is provided to the user (e.g., an alarm that is audible, visual, haptic, vibrational, etc.).
The reservoir or connector set comprises a microfluidic valve, an electronically activated valve, a solenoid valve, a hydro-mechanical operated valve, and/or pneumatic valve. The microfluidic valve (or other valve) is actuated by the pump and allows flow when the drive motor is active. The microfluidic valve (or other valve) is closed when the drive motor is inactive. The active closing and opening of the actuating valve prevents inadvertent dosing when the drive motor is not active.
Redundant mechanisms could be put in place to prevent inadvertent separation or lift-off of the elastomeric plunger from the drive nut. The elastomeric plunger insert could be made of an electrically conductive material having magnetic properties (such as an electrically conductive plastic loaded with ferrous material), and a check valve could be integrated into the needle connector. Coupled with a magnet located at the tip 2702 of the drive nut 2700 in each pump chamber, and a passive electrical circuit installed on top of that magnet, which would be powered remotely via RFID from an active circuit installed somewhere within the pump housing, these systems could simultaneously serve to prevent inadvertent separation or lift-off of the elastomeric plunger from the drive nut, to capture the elastomeric plunger by the drive nut, and to detect (and continuously monitor) that the elastomeric plunger has been captured by the drive nut.
Utilizing a needle transfer hub to transfer medicament from a vial to the cartridge, the body of the needle transfer hub could be manufactured from the same mold as the needle connector, except without the capture-and-locking feature as the needle transfer hub would need to be removed from the cartridge upon completing the filling procedure, whereas the needle connector would permanently capture the cartridge and would be disposed of along with the cartridge once the cartridge was emptied of its deliverable contents.
Involving a single medicament or multiple medicaments, the inlet end of each tubing is overmolded, bonded, press-fitted, glued, solvent bonded, insert molded, or otherwise attached to a needle connector (e.g., the inlet connector) and the outlet end of each tubing is overmolded, bonded, press-fitted, glued, solvent bonded, insert molded, or otherwise attached together with an infusion site and a cannula that delivers the medicament or medicaments to the delivery area (e.g., delivery transdermally, intradermally, subcutaneously, intramuscularly, intravenously, etc.).
Involving a single medicament or multiple medicaments, the inlet end of each tubing is overmolded, bonded, press-fitted, glued, solvent bonded, insert molded, or otherwise attached to a needle connector (as inFigures 1A-4B) and the outlet end of each tubing is overmolded, bonded, press-fitted, glued, solvent bonded, insert molded, or otherwise attached to a straight, beveled, hollow, stainless steel needle and a component designed to connect to a subcutaneous or intradermal infusion site base (as in the dual-medicament infusion site connectors inFigures 8,9, and13, and the single-medicament infusion site connectors inFigures 11 and12). For each medicament, this arrangement creates a closed, independent, patent, and continuous fluid path from the medicament reservoir to the end of the straight, beveled, hollow, stainless steel needle in the site connector. Each site connector can be physically independent and can connect to or disconnect from an infusion site base repeatedly.
Figures 7A-B are isometric views showing a portion of a dual-medicament infusion set.Figure 7A shows an embodiment of a dual-medicament site base inserter 2426 attached. InFigure 7B the dual-medicament site base inserter 2426 has been removed. Involving two medicaments, the dual-medicament site base inserter 2426 couples two disjoint halves: the right site base 2424 (e.g., the first base, the glucagon base, etc.), and the left site base 2525 (e.g., the second base, the insulin base, etc.). The inserter 2426 provides a handle for the application of the dual-medicament infusion site base 2401. The base 2401 includes one or more needle guards 2429, 2529. The infusion set base 2401 comprises one or more release liners 2428, 2528. The infusion set base 2401 comprises an adhesive 2427, 2527 (e.g., a tape, gel, rubber adhesive, etc.). Once the two needle guards 2429, 2529 and the two release liners 2428, 2528 have been removed and discarded, the dual-medicament site base inserter 2426, can be used to apply the dual-medicament infusion set base 2401. The adhesive tape 2427, 2527 can be used to adhere the dual-medicament infusion set 2401 to the surface of the skin. After insertion, the dual-medicament site base inserter 2426 is disposable and is removed by activating the two living hinges 2436, 2536 and sliding the dual-medicament site base inserter 2426 out of the retention slots 2430, 2530 (shown inFigure 9B) to reveal the two posts 2431, 2531 that are now ready to accept site connectors (seeFigures 8A-B). As shown inFigure 7B, the posts 2431, 2531 are asymmetric. The infusion set inserter 2426 is reusable and can be reattached to the site bases 2424, 2525.
The infusion set includes a connector cover 2434.Figure 8A is an isometric view showing the dual-medicament infusion site connectors 2432, 2533 with a dual- medicament site connector cover 2434 attached.
Figure 8B shows the dual-medicament infusion site connectors after the dual-medicament site connector cover 2434 has been removed. The dual-medicament site connector cover 2434 couples the two disjoint halves: the first site connector 2432, and the second site connector 2533. The site connector cover 2434 protects the site connectors 2432, 2533 from exposure (e.g., to dust, dirt, abrasion, physical damage, etc.) when they are not connected to the dual-medicament infusion site base 2401 (shown inFigure 7A). The second site connector 2533 can be disconnected from the dual-medicament site connector cover 2434 by activating the living hinge 2536 to release the retention clip 2535 and then sliding the second site connector 2533 out of the retention slot 2530 (shown inFigure 9B). Disconnection of the second site connector 2533 from the dual-medicament site connector cover 2434 reveals the alignment posts 2539 and the asymmetric post receptacle 2538 which mate with corresponding features on the left site base 2525 (shown inFigure 7B). The same procedure can be used to disconnect the first site connector 2432 from the dual-medicament site connector cover 2434, using corresponding features and similarly tens-place enumerated features (e.g., 2436 corresponds to 2536). The order of disconnection from the dual-medicament site connector cover 2434 and reconnection to the dual-medicament infusion site set base 2401 is arbitrary.
As shown inFigure 6G, the infusion site connector 2632 comprises an ergonomic feature (e.g., a flared-out edge, a finger hold, a bulbous end, etc.). The ergonomic feature allows the infusion site connector to be easily grasped and pulled from the infusion base. As shown inFigure 6F, the infusion site connector 2632 can have a thin section and a thick section, with the thick section being located proximal (towards) the tubing 301, and the thin section being proximal to base connection point. This design feature, similar to the ergonomic feature, allows the infusion site connector to be easily grasped by the finger tips and slid away from the infusion base.
Figure 9A shows an isometric view of the complete dual-medicament infusion set 2400 including the dual- medicament infusion site base 2401 assembled with the dual-medicament infusion site connectors. As shown, the infusion set comprises a first infusion assembly comprising a first base and a first connector and a second infusion assembly comprising a second base and a second connector. Having the bases separate prevents needle pull in a system where both needles are fixed to a single base. This feature increases comfort when the infusion set is placed on an area where movement, pulling, and discomfort can occur.Figure 9B shows a cross-sectional view revealing the internal components of the dual-medicament infusion set 2400. After connection of the first site connector 2432 and the second site connector 2533, to the first site base 2424 and the left site base 2525, respectively, two closed, independent, patent, and continuous fluid paths are created. The fluid paths terminate at 90 degree, beveled, hollow, piercing members 2442, 2542 (stainless steel needles). Each fluid path can begin in many types of connections to a fluid reservoir such as luer locks or custom cartridge connectors that eventually communicate with the lumen of the tubing 301 which is bonded together with a straight, beveled, hollow, stainless steel needle 2440, 2540 and an infusion site connector 2432, 2533, respectively. Upon connecting an infusion site connector(s) to an infusion site base(s), the straight, beveled, hollow, stainless steel needle 2440, 2540 pierces a site base septum 2441, 2541 respectively, allowing fluid to be pushed through the 90 degree, beveled, hollow, stainless steel needle 2442, 2542 for delivery to the patient. Lettering (or other visual indicators) 2450, 2550 are present on the infusion set 2400. For example as shown inFigure 9A, the indicators 2442, 2542 provide convenience to a user, though, mis-connection of components is still mechanically prevented. The 90 degree, beveled, hollow, stainless steel needle 2442, 2542 is placed using a sub-assembly consisting of itself, a soft durometer tube 2451, 2551 and the site base septum 2441, 2541 which is then secured with a plug (not shown).
Figure 10A is an isometric view showing the first site base 2424 (shown inFigure 7B), as it would be used in the single-medicament configuration. A first site base inserter 2443 can be attached as shown.Figure 10B shows the first base 2424 after the first site base inserter 2443 has been removed. The first site base inserter 2443 provides a handle for the application of the single-medicament infusion site base 2424. After insertion, the first site base inserter 2443 is removed by activating the living hinge 2436 and sliding the right site base inserter 2443 out of the retention slot, 2430, to reveal the asymmetric post, 2431 that is now ready to accept a site connector 2432. Although only the first half of the dual-medicament infusion site base 2401 (shown inFig. 7B) is shown, the second half 2433 could also be used in a single-medicament configuration. The second half 2433 could be attached using the same strategy as for the first half 2432, but with components having uniquely pairing features, hinges, etc.
Figure 11A shows an isometric view of the first site connector 2432 (shown inFigure 8), as it would be used in the single-medicament configuration, with the first site connector cover 2446.Figure 11B shows the first site connector 2432 after the first site connector cover 2446 has been removed. The first site connector cover 2446 protects the first site connector 2432 from exposure (e.g., to dirt, grime, debris, physical damage from bumps, etc.) and can be removed by activating the living hinge 2436, to release the retention clip 2435 and then sliding the first site connector 2432 out of the retention slot 2430 (shown inFigure 12B). Disconnection of the first site connector 2432 from the first site connector cover 2446 reveals the alignment post 2439 and the asymmetric post receptacle 2438, which mate with corresponding features on the first site base 2424 (shown inFigure 10). Although this depiction describes only the first half of the dual-medicament infusion site connectors (shown inFigure 8), the second half could also be used in a single-medicament configuration with similarly numbered features.
Figure 12A shows an isometric view of the complete single-medicament infusion set 2400' including the single-medicament infusion site base 2424 assembled with the single-medicament infusion site connector 2432.Figure 12B shows a cross-sectional view revealing the internal components of the single-medicament infusion set 2400'. After connection of the first site connector 2432 to the first site base 2424, a closed, independent, patent, and continuous fluid path is created. The closed fluid path terminates in a 90 degree piercing member, 2442 (e.g., a beveled, hollow, stainless steel needle). The fluid path can begin in many types of connections to a fluid reservoir such as luer locks or custom cartridge connectors that eventually communicate with the lumen of the tubing 301. The tubing 301 is bonded together with a straight piercing element 2440 (e.g., a beveled, hollow, stainless steel needle) and, in this depiction, the first site connector 2432. Upon connecting the first site connector 2432 to the right site base 2424, the straight, beveled, hollow, stainless steel needle 2440 pierces the site base septum 2441, allowing fluid to be pushed through the 90 degree, beveled, hollow, stainless steel needle 2442, for delivery to the patient. Although this depiction is analogous only to the first half of the dual-medicament infusion set (shown inFigures 9A-B), the second half of the infusion set (e.g., the left half) could also be used in a single-medicament configuration. Lettering or other visual indicators 2450, 2550 are present and provide convenience to a user. Beside the visual indicators, mis-connection of components is still mechanically prevented. The 90 degree, beveled, hollow, stainless steel needle 2442 is placed using a sub-assembly consisting of itself, a soft durometer tube 2451 and the site base septum 2441 which is then secured with a plug (not shown).
Figures 13A-E show isometric views of embodiments of a dual-medicament infusion set.Figure 13A with the right site base 2424, connected to a right site base cover 2444.Figure 13B shows the second site base 2525 connected to a second site base cover 2545.Figure 13C shows the first site connector 2432 connected to a first site connector cover 2446.Figure 13D shows the second (left) site connector 2533 connected to a second (left) site connector cover 2547.Figure 13E shows the dual-medicament infusion site base 2401 connected to a dual-medicament site base cover 2448. When an individual site connector must be replaced, it can be disconnected from its site base and a site base cover can be temporarily connected to the site base thereby protecting it from exposure (as in A and B) until the site connector can be replaced. If both site connectors are removed together, a dual-medicament site base cover 2448 can be connected temporarily to both site bases to protect them from exposure until the site connectors can be replaced (as in E). When any individual site base must be replaced, it can be disconnected from its site connector and a site connector cover is temporarily connected to the site connector thereby protecting it from exposure (as in C and D) until the site base can be replaced. If both site bases are removed together, a dual-medicament site connector cover can be connected temporarily to both site connectors to protect them from exposure until the site bases can be replaced (as inFigure 8A). A single-medicament embodiment could operate in the same manner as the right site half of A and C or the left site half of B and D.
A single-medicament implementation of the infusion system that infuses only medicament A can use one of the two single-medicament infusion site connectors of the dual-medicament infusion site connectors. Similarly, the other single-medicament infusion site connector, which is distinct from the single-medicament infusion site connector for medicament A, can be used for a single-medicament implementation of the infusion system that infuses only medicament B. Asymmetric features in the dual-medicament infusion site connectors, such as any combination of asymmetric posts, asymmetric post receptacles, retention clips, alignment posts, and/or keys and keyways can be used to differentiate the single-medicament infusion site connector for medicament A from medicament B. Such features can also be used to ensure that a single-medicament implementation of the infusion system that infuses only medicament A uses only the medicament A chamber in the pump housing, and a single-medicament implementation of the infusion system that infuses only medicament B uses only the medicament B chamber in the pump housing. In this way, the same molds used to manufacture the dual-medicament infusion site connectors will serve for the single-medicament infusion site connectors for a single-medicament implementation of the infusion system that infuses only medicament A or only medicament B. Thus, the constituent components of the dual-medicament infusion site base, dual-medicament infusion site connectors, tubing, and needle connectors, which serve a dual-medicament implementation of the infusion system, can be used to serve one of two distinct single-medicament implementations of the infusion system, one for medicament A and one for medicament B.
Software (either integrated into the infusion system or run on an auxiliary device such as a smart- phone or tablet) can be used to configure (automatically and/or manually) the infusion system to be configured either as a dual-medicament infusion system, as a single-medicament infusion system that uses only the medicament A chamber in the pump housing, or a single-medicament infusion system that uses only the medicament B chamber in the pump housing. Once any of these three configurations is implemented, the dual-medicament infusion site connectors or appropriate single- medicament infusion site connectors (either pertaining to medicament A or medicament B) can be chosen to match the particular configuration.
Involving a site connector or site connectors, each site connector can be designed to connect to a site base by the action of at least one retention clip. Connection of a site connector to a site base allows a straight, beveled, hollow, stainless steel needle to pierce a septum in the site base (as inFigures 9 and12). Once the straight, beveled, hollow, stainless steel needle in a site connector pierces the site base septum in a site base, it is brought into fluid continuity with a 90 degree, beveled, hollow, stainless steel needle, which can deliver the medicament to the delivery space. This arrangement creates, for each medicament, a closed, independent, patent, and continuous fluid path from the medicament reservoir to the patient (e.g., for delivery transdermally, intradermally, subcutaneously, intramuscularly, intravenously, etc.). Each site base can be physically independent and can connect to or disconnect from a site connector repeatedly.
Involving the use of a site base, the 90 degree, beveled, hollow, stainless steel needle can be overmolded, bonded, press-fitted, glued, solvent bonded, insert molded, or otherwise attached to the site base. As an example other than insert molding, such a 90-degree, beveled, hollow, stainless steel needle may be sheathed with a soft durometer tube, which is in turn pressfit into the site base septum to create a sub-assembly outside the site base. This sub-assembly can then be placed into a cavity in the site base (as shown inFigures 9 and12) and a plug (not shown) can be used to hold the sub-assembly firmly in place while simultaneously ensuring a fluid seal.
Involving the use of a site base, the 90 degree, beveled, hollow, stainless steel needle, the needle may be designed to protrude from the center or near the center of the site base. This arrangement increases the likelihood that the site base will remain adhered to the surface of the skin for the entirety of its intended use.
Involving multiple medicaments where a site connector can be connected to or disconnected from a site base, the site connectors and site bases can contain features such as lettering or other visual indicators to help prevent mis-connection of a site base or a site connector to incorrect site connectors or site bases. Such lettering or other visual indicators (colors, etc.) can be used in addition to physical features that mechanically prevent mis-connection. The lettering or other visual indicators can be raised and colored differently from the base material to enhance visibility.
Involving multiple medicaments where a site connector can be connected to or disconnected from a site base, the site connectors and the site bases can contain features such as asymmetric post receptacles, retention clips, alignment posts, and/or keys and keyways that prevent mis-connection of a site base or a site connector to incorrect site connectors or site bases.
Involving a site connector or site connectors, each site connector can be designed to connect to a site base by the action of at least one retention clip that fits into at least one retention slot. Involving two medicaments where only one retention clip and retention slot pair is used on each site connector and site base pair, the retention clips and retention slots may be present on the medial or lateral (as inFigures 7-9) sides of the site connectors and site bases. If the retention clips and retention slots are present on the lateral side of one site connector and site base pair, and on the medial site of the other site connector and site base pair, convenience is afforded to the user by allowing for the same finger to activate the living hinges. In this case, mis-connection of the site connectors to incorrect site bases is still prevented by the presence of the asymmetric posts and asymmetric post receptacles.
Involving two medicaments, a right site connector and a left site connector (as inFigures 8,9, and13) comprise the dual-medicament infusion site connectors, can be physically independent, and can contain features such as asymmetric post receptacles, retention clips, alignment posts, and/or keys and keyways that prevent mis-connection of the dual-medicament infusion site connectors to a dual-medicament infusion site base.
Involving two medicaments, a right (first) site base and a left (second) site base (as inFigs. 7,9, and13) comprise the dual-medicament infusion site base, can be physically independent, and can contain features such as retention slots (shown inFigure 9), asymmetric posts, and alignment post receptacles that prevent mis-connection of the dual-medicament infusion site connectors to the dual- medicament infusion site base.
The site connectors and site bases are designed such that any site connector and site base pair from a multiple medicament configuration can be used individually in a single medicament configuration (as inFigures 10-12) such that the single medicament site connectors and site bases can be manufactured from the same tools as the multiple medicament site connectors and site bases.
Involving multiple medicaments, the site connectors can be supplied with one or more site connector covers that may couple all of the site connectors, certain groups of the site connectors, or none of the site connectors such that each site connector can be supplied with its own site connector cover. The site connector cover can be connected to and disconnected from the site connectors repeatedly and protects them from exposure (as inFigure 8A). Likewise, the site bases can be supplied with one or more site base covers that may couple all of the site bases, certain groups of the site bases, or none of the site bases such that each site base can be supplied with its own site base cover. The site base cover can be connected to and disconnected from the site bases repeatedly and protects them from exposure (as inFigure 13).
Involving a single medicament or multiple medicaments wherein each site base is supplied with its own site base cover and each site connector is supplied with its own site connector cover, the site base covers and the site connector covers could be manufactured from the same tools as the site bases and the site connectors respectively. Each site base cover may not contain the straight, beveled, hollow, stainless steel needle and the tubing and each site connector cover may not contain the 90 degree, beveled, hollow, stainless steel needle and the site base septum.
Involving a single medicament or multiple medicaments, the site base or site bases can be supplied with a site base inserter that connects to the site base or site bases in the same manner as the site connectors and provides a handle for the application of site base or site bases (as inFigures 7 and10). The handle provided by the site base inserter may be used to apply the site base manually or to load the site base(s) into an automated insertion device, such as a spring loaded inserter. In the case of multiple site bases, one or more site base inserters may couple all of the site bases, certain groups of the site bases, or none of the site bases such that each site base can be supplied with its own site base inserter. Removal of a site base inserter would decouple any coupled site bases.
The infusion pump may be equipped with a cartridge detection hardwaresoftware system that would detect, separately, whenever each cartridge is fully loaded and secured in its corresponding pump chamber. Since the design described herein can ensure that only the correct medicament cartridge can be fully loaded and secured in its corresponding pump chamber, the cartridge detection system can, when functioning in conjunction with the design described herein, effectively and conclusively inform the infusion pump system of which specific medicaments are available for potential infusion. The availability status of each medicament for potential infusion at any point in time would also allow the infusion pump system to set its mode of operation accordingly. For example, in the case of a dual-chamber pump, the detection of both cartridges being in place would allow the infusion pump system to operate in dual-infusion mode, whereas the detection of one cartridge being in place but not the other would lead the infusion pump system to operate in a single-infusion mode that is specific to the medicament that corresponds to the cartridge that is detected to be in place. This detection capability would be determined autonomously in real time, including when a cartridge is in place or out of place transiently or temporarily.
The infusion pump may also be equipped with a delivery occlusion hardwaresoftware detection system that would detect, separately, whenever the fluid-delivery path associated with each cartridge is impeded or obstructed anywhere from the cartridge, all the way through the corresponding tubing, and out to the distal end of the corresponding site base. Since the design described herein can ensure that only the correct tubing assembly and site base can be connected to their corresponding cartridge, the occlusion detection system would, when functioning in conjunction with the design described herein, effectively and conclusively inform the infusion pump system of which specific medicaments have a patent fluid-delivery path.
With both cartridge and occlusion detection systems simultaneously present, the infusion pump may at any point in time conclusively determines which medicament is possible to deliver to the user. The infusion pump could then autonomously set its mode of operation, as per the detection of which of the cartridges are in place along with the patency of their corresponding fluid-delivery paths. In a specialized example of a dual-chamber pump that autonomously controls blood glucose levels by delivering insulin or an insulin analog, as well as a counter-regulatory agent (e.g. glucagon, a glucagon analog, or dextrose), such cartridge and occlusion detection systems, when functioning in conjunction with the design described here, would practically allow the infusion pump system to be prescribed in a particular configuration to deliver only insulin, or only the counter-regulatory agent, or both. Moreover, such an implementation would also allow the dual-chamber infusion pump system to autonomously switch its mode of operation in real time whenever either delivery channel becomes unavailable for delivery (whether informed by cartridge detection, occlusion detection, or both), including in cases where channel availability may alternate in real time. The cartridge and occlusion detection methods could be realized through a variety of hardware and software implementations, including, but not limited to, techniques that rely on magnetic field or electrical signal feedback in the case of cartridge detection, or techniques that rely on back pressure detection or flow sensor technology in the case of occlusion detection, to mention but a few.
The features described in the context of one base, connector, housing, inlet connector, inlet connector cover, collar, medicament reservoir, or pump assembly can be mixed and matched and used in different combinations on other bases, connectors, housings, inlet connectors, inlet connector covers, collars, medicament reservoirs, or pump assemblies. For instance, any feature described above to prevent mischanneling can be deleted from or added to other embodiments. Redundant features can be added or deleted from the components of the medicament delivery systems.
The examples shown here are meant to be representative of a general approach to the design of an infusion system for multiple medicaments and various connectors, tubes, and cartridges to ensure proper channeling of each medicament to the patient. The geometric shapes, sizes, orientations, locations, and number of tabs, protrusions, and features, as well as the corresponding cavities, grooves, keyways, or slots are merely meant to be examples of a much greater abundance of variations on the particular examples shown here.
For instance, as described elsewhere herein, the degrees of separation between the tabs, protrusions, and features on the cap connectors and on the corresponding cavities, grooves, keyways, or slots in the pump housing, or the degrees of separation between the tabs, protrusions, and features on the pre-fitted collar assembly and the corresponding cavities, grooves, keyways, or slots on the cap connector shown here can be generalized to be placed closer together or farther apart than in the examples shown here. Additionally, the number of tabs, protrusions, and features on the cap connectors and on the corresponding cavities, grooves, keyways, or slots in the pump housing, or the number of tabs, protrusions, and features on the pre-fitted collar assembly and the corresponding cavities, grooves, keyways, or slots on the cap connector designs shown here can be generalized to one, two, three or more such features, which might have different sizes, shapes, orientations, and locations from the examples shown here. Moreover, as discussed above, the locations of the tabs, protrusions, and features on the pre-fitted collar assembly and the corresponding cavities, grooves, keyways, or slots on the cap connector designs shown here need not be limited to the neck or head (or crown) regions of the cartridge. For instance, the point of engagement between the pre-fitted collar assembly and the cap connector could alternatively occur elsewhere on the body of the cartridge, or extend over the entire length of the cartridge. The tabs, protrusions, and features on the pre-fitted collar assemblies described here could instead appear directly on the surface of the cartridge (such as in the case of an injection molded cartridge), which is either pre-filled with medicament or not pre-filled with medicament.
The cartridges described here can either be pre-filled with medicament or not pre-filled with medicament before or after the pre-fitted collar assemblies described here are installed onto the cartridge. In the case of the latter, such cartridges can be filled with medicament sometime after the manufacturing process, including at the point of care.
For example in the case of a cartridge that is filled with medicament at the point of care, the cap connector might not contain a recessed needle, but rather might couple with said cartridge using a standard luer lock or other mechanism, as in Figure 50, in which the medicament flows directly from the cartridge into the tubing without first passing through a needle. In this case, the tabs, protrusions, and features on the pre-fitted collar assemblies described here would still appear on the surface of the cap connector.
Mischanneling of medicaments can still be avoided if one cartridge is prefilled with one medicament and a second cartridge is filled at the point of care with a different medicament (using the embodiment described inFigures 5A-C). So long as only one cartridge needs to be filled with medicament at the point of care, and all other cartridges are pre-filled with medicaments, the designs described here can prevent medicament mischanneling.
The features and components described above are applicable to reusable injection pens (e.g., insulin pens, etc.). Each collar, cap, input connector, etc. could be applied to prevent incorrect dosing of drugs delivered by injection pens. For example, one unique cartridge, having a first set of unique features as described above could be used to deliver long-acting insulin to a patient via a mated injection pen. Another unique cartridge, with a second set of unique features as described above could be used to deliver fast-acting or ultra-rapid insulin analogs to a patient via a different mated injection pen. As a further example, these features can be used to differentiate between more and less concentrated insulin analogs (e.g. U100, U200, or U500 insulin analogs).
The medicament described above for any embodiment can include any suitable compound or drug for treating, regulating, controlling or addressing one or more conditions of the patient. While diabetes mellitus is a target, other conditions can be addressed as well (e.g., pancreatic misfunction). The medicament can include for example a regulating agent, such as insulin, for regulating the blood glucose levels in the patient and/or a counter-regulatory agent, such as glucose or glucagon, for more effective blood glucose regulation in certain circumstances. Other type of agents can be used as well.
An infusion system for multiple medicaments involving various needle sites, connectors, tubes, and cartridges that ensure proper channeling of each medicament to the patient is provided. The infusion system comprises an infusion pump. The infusion system comprises an infusion pump with two or more pump chambers. The infusion system comprises cartridges that can be filled at the point of care with different medicaments (or may be pre-filled with different medicaments). The infusion system comprises connectors and tubing that connect the cartridges to the infusion pump in such a way as to prevent mischanneling or cross-channeling of medicaments. Each type of cartridge for each type of medicament has unique differentiating sizes, shapes, and/or geometrical features (either as an integral part of the cartridge or as a component attached or affixed to the cartridge) that allow for unique coupling with a type of connector that itself has unique differentiating features that engage corresponding features in the pump housing and only allow for insertion of the proper cartridge into the proper pump chamber within the infusion pump.
The systems described above can be used for the delivery of single medicaments, or combinations of medicaments. For instance, the infusion set can be used to deliver agent A (e.g., insulin), while the features of that infusion set would be incompatible with the medicament reservoir for agent B (e.g., glucagon). Alternatively, the infusion set can be used to deliver agent B, while the features of that infusion set would be incompatible with the medicament reservoir for agent A. Additionally, as described above, dual medicaments can be delivered without mischanneling (e.g., bi-hormonal delivery, dual drug delivery, etc.). As is apparent from the disclosure above, configurations for the delivery of a plurality of medicaments (e.g., two, three, four, or more) without mischanneling can be provided.
Methods of making the infusion systems disclosed herein are provided that are useful for understanding the invention. Various needle sites, connectors, tubes, and cartridges that ensure proper channeling of each medicament to the patient are assembled. The method comprises assembling an infusion system with an infusion pump. The method comprises assembling an infusion system with a pump having two or more pump chambers. The method comprises assembling an infusion system with connectors and tubing that connect the cartridges to the infusion pump in such a way as to prevent mischanneling or cross-channeling of medicaments. Each type of cartridge for each type of medicament is assembled to have unique differentiating sizes, shapes, and/or geometrical features (either as an integral part of the cartridge or as a component attached or affixed to the cartridge) that allow for unique coupling with a type of connector that itself has unique differentiating features that engage corresponding features in the pump housing and only allow for insertion of the proper cartridge into the proper pump chamber within the infusion pump.
The pump can include a controller. The controller includes a memory and one or more hardware processors. The memory can include a non-transitory, computer-readable medium capable of storing computer-executable instructions for the pump or infusion system. The executable instructions can correspond to the processes and functions described above. For example, the executable instructions can correspond to the detection sequence described above and/or other processes such as reading optical codes, operating valves, and/or providing indications as described elsewhere herein. The executable instructions also include instructions for controlling hardware components of the pump, for example, the motor, scanners, etc. The executable instructions can be implemented in C, C++, JAVA, or any other suitable programming languages. The controller can include electronic circuits, for example, application specific circuitry such as ASICs and FPGAs, where some or all of the portions of the executable instructions can be implemented using the electronic circuits.
The computer-readable medium storing computer-executable instructions, when executed by one or more hardware processors, cause the one or more hardware processors to perform one or more of the following: urge the drive nut forward with force that is insufficient to move a plunger of an medicament reservoir, detect when the drive nut has contacted the plunger, determine if the plunger is that of an appropriately or inappropriately placed medicament, increase the force applied to the drive nut to deliver the medicament where the medicament reservoir is appropriate to deliver the medicament, or decrease the force applied to the drive nut and/or stop and/or retract the drive nut where the medicament reservoir is inappropriately placed in the pump.
The computer-readable medium storing computer-executable instructions, when executed by one or more hardware processors, cause the one or more hardware processors to perform one or more of the following: receive information concerning the medicament reservoir that is present in the pump, compare the medicament reservoir to medicament settings on the pump assembly, indicate a deviation from or proximity to the medicament settings based at least in part on a comparison of the settings required for the medicament reservoir and the settings on the pump, and/or adjust the settings of the pump to match appropriate medicament settings based on the medicament reservoir that is present.
One or more of the settings of the infusion assembly or other information as described elsewhere herein can be stored as one or more executable program modules in the memory of the controller and/or on other types of non-transitory computer-readable storage media, and the system can interact with computing assets over a network or other communication link. The system may have additional components or fewer components than described above. For example, the controller of the pump can communicate to a server or another computing device over the network.
Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein can be performed in a different sequence, can be added, merged, or left out altogether (e.g., not all described operations or events are necessary for the practice of the algorithm). Moreover, in certain embodiments, operations or events can be performed concurrently, e.g., through multi-threaded processing, interrupt processing, or multiple processors or processor cores or on other parallel architectures, rather than sequentially.
The various illustrative logical blocks, modules, routines, and algorithm steps described in connection with the embodiments disclosed herein can be implemented as electronic hardware, or as a combination of electronic hardware and executable software as discussed above with respect to controller.