Embodiments relate to medicament infusion systems. In particular, embodiments relate to a medicament infusion system incorporating a multipurpose, programmable pump assembly into a medicament infusion system, compliant with an approved connectivity standard. More particularly, embodiments provide for an infusion system that is fully compliant with international standard ISO 80639-1 (Small-bore Connectors for Liquids and Gases in Healthcare Applications; General Requirements), while enabling operational redeployment of a multipurpose infusion pump used in the infusion system.
Infusion pumps are used to administer various types of drugs, nutritional compositions, and prescribed fluids or fluid-like substances (collectively, “medicaments”) to patients in volume and time controlled doses. The pumps can be used to transfer medicaments, that are stored in storage containers such as cassettes and bags, to be administered to patients via infusion systems through various routes of delivery, such as intravenously, neuraxially, and enterally. Of necessity, the infusion systems typically include various conduits and connectors for connecting the storage containers to the pumps, and the pumps to patients.
Luer connectors are commonly used to make leak-free connections between medicament containers, conduits, pumps and patients. A Luer male-taper fitting can quickly and effectively be inserted into a female part to effect a reliable fluid tight connection. Notwithstanding the effectiveness and ease of use provided by Luer connectors, concern has grown regarding the widespread use of a single type of connector in multiple applications that can be inherently incompatible. In particular, the use of a single type of connector invites the possibility of misconnecting a fluid source to an incompatible route of delivery. A medicament to be delivered enterally through a PEG tube, for example, could mistakenly be administered intravenously by misconnection to a peripheral cannula, if both the PEG tube and the cannula were fitted with the same type of connector. Even the same type of medicament will have different dosages depending on the route of delivery; and misapplication of either the medicament or the dosage through an inappropriate route of delivery can negate the curative benefit of the drug, and can, in some circumstances, even be fatal.
In an effort to reduce the potential for a misconnection leading to the introduction of a particular medicament via an undesired route of delivery or other error in dosage or administration, some users will mandate the use of certain pumps for certain routes of delivery or other such dedicated protocols in their health care facilities. For example, a particular brand and model of pump could be exclusively designated for use in neuraxial delivery applications. Users within a particular facility could be trained to recognize the particular brand and model of pump as being exclusively dedicated to the designated route, thereby reducing the chance of a wrong route administration for a particular patient. Such ad hoc efforts, however, do not provide the benefits of a universal standard; instead, these ad hoc efforts tend to artificially restrict the use of the health care facility's inventory of pumps while not necessarily restricting access as desired to improper delivery routes and the like.
ISO 80369, Small-bore Connectors for Liquids and Gases in Healthcare Applications (incorporated herein by reference in its entirety), is an emerging International Standard for connectivity between medical devices, patients, and accessories. Part 1 of ISO 80369, General Requirements (incorporated herein by reference in its entirety), was published in 2010, and Parts 2-7, addressing particular applications, are works in progress at the time of this disclosure. The ISO 80369 standard assigns specific connectors to specific routes of delivery, and makes those specific connectors exclusive to their designated route. Segregating medicaments by route of delivery, and designating unique connectors for the different routes of delivery, is intended to reduce the opportunity for administration of a particular medicine via an inappropriate route of delivery.
The primary routes of delivery for medicament infusion systems are intravenous (IV), neuraxial, and enteral. Examples of infusion pumps used in medicament infusion systems include so called ambulatory pumps such as those sold by an assignee of subject matter hereof under the trade names CADD™ Prizm, Cadd™ Legacy, and CADD™ Solis. Such pumps are multipurpose pumps in that each can be used with an IV, neuraxial or enteral route of delivery, as well as others, by simply programming the individual pump appropriately. It will be understood that although this disclosure refers to and presents examples of particular pumps, the subject matter hereof is applicable to any pump intended for administering medicaments such as syringe pumps, large volume pumps, elastomeric pumps and the like. On the other hand, ISO 80369, as a connectivity standard, segregates the connectors to be used for those three routes into separate categories, the connectors for each category being incompatible with, and unconnectable to, connectors from the other categories. While a multipurpose infusion pump can be used in different applications and for different delivery routes, the function of the pump needs to match, and needs to be restricted to, the delivery route it is assigned to, as do the connectors that incorporate the multipurpose pump into the infusion system, if the benefits of a connectivity standard are to be realized.
An infusion pump assembly that could incorporate a multipurpose infusion pump into an infusion system compliant with an established connectivity standard such as ISO 80369, without compromising the flexibility of use provided by the multipurpose infusion pump, would provide decided benefits.
The problems outlined above are in large measure addressed by embodiments of the present medicament infusion system. The medicament infusion system hereof includes a multipurpose, programmable infusion pump assembly. The infusion pump assembly comprises an infusion pump and a pump attachment set adapter for operably coupling the infusion pump into the medicament infusion system. The medicament infusion system includes standardized connectors keyed to a particular type of infusion route. The function of the infusion pump, for a particular deployment, is dictated by, and is exclusive to, the attachment set adapter, and the attachment set is in turn keyed to the type of standardized connectors, preferably ISO 80639 compliant connectors, being employed by the medicament infusion system. The pump can be redeployed for use with a differently configured infusion system with the change of the pump attachment set adapter. An attachment set adapter is exclusive to both the type of standardized connectors and the function of the pump, thereby coordinating proper operation of the pump with the type of standardized connectors and related infusion route.
The infusion pump, pump attachment set adapter and attachment set hereof comprise an infusion pump assembly for delivering a medicament from a medicament container, through an infusion set, to a patient, via an infusion route. The pump has a pump inlet and a pump outlet, and the pump attachment set adapter is removably couplable to the pump inlet and outlet. A coded pump attachment set adapter outlet connector operably couples the attachment set to an infusion set, for delivering medicament from the pump to a patient. The coded attachment set outlet connector, is preferably chosen from a group of ISO 80639 compliant connectors. The pump attachment set adapter includes a coded member communicatively couplable with the pump when the attachment set adapter is coupled to the pump. The coded member conveys information to the pump, identifying the type of standardized connectors employed in the medicament infusion system; and the pump is accordingly configured to operate in a manner compatible with the route of delivery associated with the standardized connectors.
A medicament infusion system hereof includes a pump with a pump inlet and pump outlet, and an attachment set that can be coupled to the pump inlet and outlet, the attachment set including an attachment set inlet connector operably, detachably coupling the attachment set to a medicament container, a coded attachment set outlet connector operably, detachably coupling the attachment set to an infusion set, the coded attachment set outlet connector being of a particular type selected from a group of different types of ISO 80369 compliant connectors, the coded attachment set outlet connector thereby identifying a particular infusion route, and a coded attachment set pump fitting in fluid communication with the attachment set inlet connector and the coded attachment set outlet connector, the coded attachment set pump fitting being operably, communicatively couplable with the pump to convey to the pump information regarding the coded attachment set outlet connector, thereby identifying to the pump the particular infusion route. The medicament infusion system can include a pump attachment set adapter operably, removably coupled to the pump for removably receiving the coded attachment set pump fitting, the pump attachment set adapter configured to operably, exclusively receive only a particular type of coded attachment set pump fitting selected from a plurality of differently coded types of attachment set pump fittings, whereby the operation of the pump is responsive to and exclusive to the coded attachment set outlet connector.
Referring to the drawings, a medicament infusion system 20 in accordance with an embodiment broadly includes a multipurpose infusion pump 22, an attachment set 24 and a pump attachment set adapter 26. Attachment set 24 is adapted for connection to a medicament container 28 and an infusion set 30. As schematically depicted in
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With reference now to all of the drawings, it is incumbent upon the attending health care provider or other authorized user (“user”) to properly provide and introduce an appropriate infusion set 30 to a patient. For instance, if the patient is to receive medicament through an intravenous route of delivery, the user would introduce an infusion set to the patient by inserting the attached small needle or cannula of the infusion set into the subcutaneous tissue of the patient. The inlet port to the infusion set would be a connector designated by ISO 80369, Small-Bore Healthcare Connectors, for use only in intravenous applications and would be connectable only to a designated, complimentary connector 84, 84′, 84″ of an attachment set 24, 24′, 24″.
The user would next select an infusion pump 22 fitted with an appropriate pump attachment set adapter 26. That is to say, of the several varieties of attachment set adapters 26, 26′, 26″, one variety would be designated for use in intravenous applications. Once installed on the pump, the designated electrical contact 64 positioned in the designated electrical contact receiving pad 62a, 62b, 62c of the adapter would connect with the corresponding detection pin 52a, 52b, 52c of the infusion pump 22, providing a signal to the pump 22 that it is to operate only within parameters preselected as appropriate for intravenous applications. Moreover, to aid in the recognition and identification of pump configuration and use, a set color scheme or pump shape or both can be correlated with a particular pump use. For instance, with reference to
Additionally, or alternatively, the pump 22 could be equipped with a small optical camera (not shown). The unique outlet port 84, 84′, 84″ of the respective attachment set 24, 24′, 24″ could be held up to the camera for an optical identification of the unique outlet port 84, 84′, 84″, and the pump 22 could effectively program itself to match the pump functionality to the functionality associated with the outlet port 84, 84′, 84″.
As a further identification protocol, the unique outlet ports 84, 84′, 84″ of the attachment sets 24, 24′, 24″ can be fitted with keyed removable protective end caps (not shown). The pump 22 could be fitted with unique, complementary portals, for receiving the protective end caps; upon pump setup, the end cap would be removed from the outlet port 84, 84′, 84″, and inserted into a complementary pump portal, thereby signaling to the pump 22 the type of pump functionality required by and associated with the attachment set 24, 24′, 24″. The pump 22 could accordingly set up the corresponding delivery mode with appropriate drug library, display color scheme and warnings and alerts. The pump 22 could be programmed to be inoperative if more than one such connector were inserted. Additionally, the pump 22 could be programmed such that the connector would have to be removed, and a connector end cap reinserted into the portal, when the attachment set 24 is changed.
With the appropriate infusion set 30 introduced to the patient, and an infusion pump 22 selected that is properly fitted with an attachment set adapter 26 that matches the performance of the pump 22 to the selected type of infusion set, the user selects an appropriate attachment set 24, 24′, 24″. The appropriate attachment set 24, 24′, 24″ will have an outlet port 84, 84′, 84″ compatible with the inlet port of the infusion set 30. It will be recalled, from the description above and with reference to the drawings, that the outlet connector 84, 84′, 84″ is keyed to (coordinated with) the position of guide fin 108, 108′, 108″ on the pumping port 86, 86′, 86″ of the attachment set 24, 24′, 24″. It will also be recalled that the position of the fin receiving notch 74, 74′, 74″ in the notch plate 70, 70′, 70″ of the pump attachment set adapter 26, 26′, 26″ is keyed to (coordinated with) the position of the pad 62a, 62b, 62c that retains the electrical contact 64. It will accordingly be appreciated that, because the operation of the infusion pump 22 is keyed to the placement of the contact 64 on the pump attachment set adapter 26, 26′, 26″, and that the placement of the contact 64 is also coordinated with the placement of the fin receiving notch 74, 74′, 74″ on the selected pump attachment set adapter 26, 26′, or 26″, and that the placement of the guide fin 108, 108′, or 108″ of the pumping port 86 is keyed to the particular outlet connector 84, 84′, or 84″ of an attachment set, it necessarily follows that the operation of the pump 22 can be exclusively keyed to the selected type of infusion set with the installation of an appropriate attachment set 24, 24′, 24″. More particularly, with the proper coordination of the above described keyed elements, a pump can selectively be operated in a mode of operation that is exclusive to a particular type of ISO compliant connector, and that the mode of operation of the pump can be changed by, but can only be changed by, fitting the pump 22 with alternate pump attachment set adapters 26, 26′, 26″.
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In an embodiment, a method of identifying a particular infusion route to an infusion pump, the infusion pump including a pump inlet and a pump outlet, comprises providing an attachment set operably, removably couplable to the pump inlet and the pump outlet, the attachment set comprising (i) an attachment set inlet connector operably, detachably coupling the attachment set to a medicament container, (ii) a coded attachment set outlet connector operably, detachably coupling the attachment set to an infusion set, the coded attachment set outlet connector being of a particular type selected from a group of different types of ISO 80369 compliant connectors and thereby identifying a particular infusion route, and (iii) a coded attachment set pump fitting in fluid communication with the attachment set inlet connector and the coded attachment set outlet connector, the coded attachment set pump fitting being operably, communicatively couplable with the pump to convey to the pump information regarding the coded attachment set outlet connector, and thereby identifying to the pump the particular infusion route.
In embodiments, the method can further comprise providing a pump attachment set adapter operably, removably coupled to the pump for removably receiving the coded attachment set pump fitting, the pump attachment set adapter configured to operably, exclusively receive only a particular type of coded attachment set pump fitting selected from a plurality of differently coded types of attachment set pump fittings, whereby the operation of the pump is responsive to and exclusive to the coded attachment set outlet connector.
In embodiments, the method can further comprise programming the pump such that operation of the pump is responsive and exclusive to the coded attachment set outlet connector.
In embodiments, the method can further comprise programming the pump with the information regarding the coded attachment set outlet connector to enable the pump to identify the particular infusion route.
Programming a pump can comprise uploading or downloading data or information to or from a pump; providing, inserting or coupling a module, memory or other device to a pump; entering an instruction or information into a pump; accepting an instruction or information by a pump; or any other way of transferring data information to or from a pump utilizing hardware, software, firmware, wired communications, wireless communications and/or other devices or methodologies. Example devices that can be used to program a pump can include one or more of a computing device, a server, a pump programming device, a cloud device, a host device, an engine, a handheld device, a telephonic device, a dedicated programming device, and/or other devices.
In an embodiment, an attachment set removably couplable to an infusion pump comprises a coded attachment set outlet connector configured to couple the attachment set to an infusion set; and a coded attachment set pump fitting configured to couple the attachment set to the infusion pump and thereby identify to the pump a particular infusion route.
Regardless of a particular embodiment of subject matter hereof, it is to be appreciated and understood that, in general, any suitable alternatives may be employed to provide novel and inventive medicament infusion systems and pump assemblies as described by example or otherwise contemplated herein. It is also to be appreciated and understood that compositions, sizes, and strengths of various components described herein are all a matter of design choice depending upon intended uses thereof. Accordingly, these and other various changes or modifications in form and detail may also be made, without departing from the true spirit and scope of novel and inventive medicament infusion systems and pump assemblies defined by the appended claims.
Filing Document | Filing Date | Country | Kind |
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PCT/US2015/038309 | 6/29/2015 | WO | 00 |
Number | Date | Country | |
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62031678 | Jul 2014 | US | |
62065947 | Oct 2014 | US |