Infusion system

The infusion system addresses the risk of hazardous drug exposure by using a closed system with elastomeric pumps and a switch for controlled infusion, effectively reducing exposure risks for healthcare providers.

WO2025059105A1PCT designated stage expired Publication Date: 2025-03-20BECTON DICKINSON & CO
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Patent Information

Application Number
PCT/US2024/046087
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-09-11
Filing Date
2024-09-11
Publication Date
2025-03-20

AI Technical Summary

Technical Problem

Healthcare providers face risks of exposure to hazardous drugs during reconstitution, transportation, and administration, due to potential aerosolization and pressure differentials in drug vials.

Method used

An infusion system comprising three elastomeric pumps with reservoirs and lumens, a switch for fluid communication between the lumens and a patient connector, allowing for controlled infusion of chemotherapeutic drugs, heparin, and saline, while maintaining a closed system to prevent exposure.

Benefits of technology

The system effectively reduces the risk of drug exposure for healthcare providers by maintaining a closed system for drug transfer and administration, allowing for safe and controlled infusion of hazardous medications.

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Abstract

A infusion system includes a first elastomeric pump comprising a first reservoir and a first lumen, a second elastomeric pump comprising a second reservoir and a second lumen, a third elastomeric pump comprising a third reservoir and a third lumen, a switch in fluid communication with the first lumen, the second lumen, and the third lumen, and a patient connector. The switch is moveable between a first position where the first lumen is in fluid communication with the patient connector and the second and third lumens are isolated from the patient connector, a second position where the second lumen is in fluid communication with the patient connector and the first and third lumens are isolated from the patient connector; and a third position where the third lumen is in fluid communication with the patient connector and the first and second lumens are isolated from the patient connector.
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Description

INFUSION SYSTEMCROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to United States Provisional Application No. 63 / 581,733 entitled “Infusion System” filed September 11, 2023, the disclosure of which is hereby incorporated by reference in its entirety.BACKGROUND OF THE INVENTIONField of the Disclosure

[0002] The present disclosure relates generally to an infusion system.Description of the Related Art

[0003] Health care providers reconstituting, transporting, and administering hazardous drugs, such as cancer treatments, can put health care providers at risk of exposure to these medications and present a hazard in the health care environment. Unintentional chemotherapy exposure can affect the nervous system, impair the reproductive system, and bring an increased risk of developing blood cancers in the future. Some drugs must be dissolved or diluted before they are administered, which involves transferring a solvent from one container to a sealed vial containing the drug in powder or liquid form, by means of a needle. Drugs may be inadvertently released into the atmosphere in gas form or by way of aerosolization, during the withdrawal of the needle from the vial and while the needle is inside the vial, if any pressure differential between the interior of the vial and the surrounding atmosphere exists. In order to reduce the risk of health care providers being exposed to toxic drugs, the transfer of these drugs is accomplished by utilizing a closed system transfer device or system.SUMMARY OF THE INVENTION

[0004] In one aspect or embodiment, an infusion system includes a first elastomeric pump comprising a first reservoir and a first lumen, a second elastomeric pump comprising a second reservoir and a second lumen, a third elastomeric pump comprising a third reservoir and a third lumen, a switch in fluid communication with the first lumen, the second lumen, and the third lumen, and a patient connector configured to be connected to a patient catheter or infusion line. The switch is moveable between a first position where the first lumen is in fluid communication with the patient connector and the second and third lumens are isolated from the patient connector, a second position where the second lumen is in fluid communication with the patientconnector and the first and third lumens are isolated from the patient connector; and a third position where the third lumen is in fluid communication with the patient connector and the first and second lumens are isolated from the patient connector.BRIEF DESCRIPTION OF THE DRAWINGS

[0005] The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following descriptions of aspects of the disclosure taken in conjunction with the accompanying drawings, wherein:

[0006] FIG. 1 is a perspective view of an infusion system according to one aspect or embodiment of the present application;

[0007] FIG. 2 is a partial perspective view of the system shown in FIG. 1; and

[0008] FIG. 3 is a perspective view of an infusion system according to a further aspect or embodiment of the present application.

[0009] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary aspects of the disclosure, and such exemplifications are not to be construed as limiting the scope of the disclosure in any manner.DETAILED DESCRIPTION

[0010] The following description is provided to enable those skilled in the art to make and use the described aspects contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0011] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary aspects of the invention. Hence, specific dimensions and other physical characteristics related to the aspects disclosed herein are not to be considered as limiting.

[0012] Unless otherwise indicated, all ranges or ratios disclosed herein are to be understood to encompass the beginning and ending values and any and all subranges or subratios subsumed therein. For example, a stated range or ratio of “1 to 10” should be considered to include any and all subranges or subratios between (and inclusive of) the minimum value of 1 and the maximum value of 10; that is, all subranges or subratios beginning with a minimum value of 1 or more and ending with a maximum value of 10 or less.

[0013] The terms “first”, “second”, and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements.

[0014] As used herein, “at least one of’ is synonymous with “one or more of’. For example, the phrase “at least one of A, B, and C” means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, “at least one of A, B, and C” includes one or more of A alone; or one or more of B alone; or one or more of C alone; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of all of A, B, and C.

[0015] In one aspect or embodiment of the present application, an infusion system 10 includes a first elastomeric pump 12 having a first reservoir 14 and a first lumen 16, a second elastomeric pump 22 having a second reservoir 24 and a second lumen 26, a third elastomeric pump 32 having a third reservoir 34 and a third lumen 36, a switch 40 in fluid communication with the first lumen 16, the second lumen 26, and the third lumen 36, and a patient connector 42 configured to be connected to a patient catheter or infusion line. The switch 40 is moveable between a first position where the first lumen 16 is in fluid communication with the patient connector 42 and the second and third lumens 26, 36 are isolated from the patient connector 42, a second position where the second lumen 26 is in fluid communication with the patient connector 42 and the first and third lumens 16, 36 are isolated from the patient connector 42, and a third position where the third lumen 36 is in fluid communication with the patient connector 42 and the first and second lumens 16, 26 are isolated from the patient connector 42. Although three elastomeric pumps 12, 22, 32 are shown, two or more elastomeric pumps may be provided. The infusion system 10 may be a single-use ambulatory infusion system. In one aspect or embodiment, the infusion system 10 is a configured for delivering chemotherapeutic drugs or therapy.

[0016] In one aspect or embodiment, the first reservoir 14 receives a chemotherapeutic drug, the second reservoir 24 receives heparin, and the third reservoir 34 receives saline. The system 10 is configured to provide a saline flush and heparin lock of a chemotherapy infusion set and port without breaking the infusion lines which simplifies the infusion “take down” process andenables the patient to remove their own line without a clinician visit. The switch 40 is configured to be manually moved by a patient or clinician to control the flow of the three elastomeric pumps 12, 22, 32 for the different infusion steps. The switch 40 may also include a fourth position where the first, second, and third lumens 16, 26, 36 are isolated from the patient connector 42.

[0017] In one aspect or embodiment, an input valve 50 is positioned between the patient connector 42 and the switch 40, with the input valve 50 having a medical connector interface 52. The input valve 50 is moveable between a first position where the medical connector interface 52 is in fluid communication with the switch 40, a second position where the medical connector interface 52 is in fluid communication with the patient connector 42, and a third position where the medical connector interface 52 is isolated from the patient connector 42 and the switch 40. The input valve 50 may include an input connector, an output connector, and a manually moveable valve actuator to move the input valve 50 between the first, second, and third positions. In one aspect or embodiment, the medical connector interface 52 is a closed female luer. In one aspect or embodiment, the medical connector interface 52 is the Texium™ closed male luer commercially available from Becton, Dickinson and Company. The input valve 50 may be utilized to load the reservoirs 14, 24, 34 of the three elastomeric pumps 12, 22, 32.

[0018] In one aspect or embodiment, the system 10 includes a manifold 60 positioned between the input valve 50 and the switch 40, with the manifold 60 receiving the first, second, and third lumens 16, 26, 36 and including an output lumen 62 in fluid communication with the input valve 50.

[0019] In one aspect or embodiment, the first lumen 16 has smaller diameter than diameters of the second and third lumens 26, 36. The size of the lumens 16, 26, 36 may be selected to provide optimized infusion rates for the three infusates, such as slower for the chemotherapeutic drug and faster for flushing and heparin. The first reservoir 14, which may be utilized for the chemotherapeutic drug, may be larger in volume than volumes of the second and third reservoirs 24, 34, which may be utilized for saline and heparin.

[0020] In one aspect or embodiment, the switch 40 is color-coded with respective colors corresponding to the three positions of the switch 40 to provide a color indication regarding the position of the switch 40. Further, the elastomeric pumps 12, 22, 32, including at least a portion of the lumens 16, 26, 36, may be enclosed by an outer layer or casing 70.

[0021] Referring to FIG. 3, an infusion system according to a further aspect or embodiment of the present application is shown. Although not shown in FIG. 3, the first, second, and thirdlumens 16, 26, 36 discussed above may be replaced by a two-channel coextruded tube, one small tube and one larger tube. The two-channel coextruded tube may be two tubes lying side- by-side and stuck together along one edge. The saline and heparin flushes may share the same larger-lumen tube. The switch still only accesses one of the three reservoirs at a time, but two of the switch positions are channeled to the same downstream lumen. Although not shown in FIG. 3, two larger lines would be merged to the left of the dial switch.

[0022] While this disclosure has been described as having exemplary designs, the present disclosure can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this disclosure pertains and which fall within the limits of the appended claims. To the extent possible, one or more features of any aspect or embodiment discussed above can be combined with one or more features of any other aspect or embodiment.

Claims

THE INVENTION CLAIMED IS:

1. A infusion system comprising: a first elastomeric pump comprising a first reservoir and a first lumen; a second elastomeric pump comprising a second reservoir and a second lumen; a third elastomeric pump comprising a third reservoir and a third lumen; a switch in fluid communication with the first lumen, the second lumen, and the third lumen; and a patient connector configured to be connected to a patient catheter or infusion line, the switch moveable between a first position where the first lumen is in fluid communication with the patient connector and the second and third lumens are isolated from the patient connector, a second position where the second lumen is in fluid communication with the patient connector and the first and third lumens are isolated from the patient connector; and a third position where the third lumen is in fluid communication with the patient connector and the first and second lumens are isolated from the patient connector.

2. The system of claim 1, further comprising an input valve positioned between the patient connector and the switch, the input valve comprising a medical connector interface, wherein the input valve is moveable between a first position where the medical connector interface is in fluid communication with the switch, a second position where the medical connector interface is in fluid communication with the patient connector, and a third position where the medical connector interface is isolated from the patient connector and the switch.

3. The system of claim 2, further comprising a manifold positioned between the input valve and the switch, the manifold receiving the first, second, and third lumens and comprising an output lumen in fluid communication with the input valve.

4. The system of any of claims 1, wherein the first lumen has smaller diameter than diameters of the second and third lumens.

5. The system of any of claims 1, wherein the first reservoir is larger in volume than volumes of the second and third reservoirs.

Citation Information

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