Infusion system

Abstract

The infusion system includes a first elastomer pump including a first reservoir and a first lumen, a second elastomer pump including a second reservoir and a second lumen, a third elastomer pump including a third reservoir and a third lumen, a switch that fluidically communicates with the first lumen, the second lumen, and the third lumen, and a patient connector. The switch is movable between a first position in which the first lumen is fluidically communicating with the patient connector and the second and third lumens are isolated from the patient connector, a second position in which the second lumen is fluidically communicating with the patient connector and the first and third lumens are isolated from the patient connector, and a third position in which the third lumen is fluidically communicating with the patient connector and the first and second lumens are isolated from the patient connector.

Description

[Technical Field]

[0001] (Cross-Reference to Related Application) This application claims the benefit of U.S. Provisional Application No. 63 / 581,733, entitled "Infusion System", filed on September 11, 2023, the disclosure of which is hereby incorporated by reference in its entirety.

[0002] The present disclosure generally relates to infusion systems. [Background Art]

[0003] Medical providers who reconstitute, transport, and administer hazardous drugs such as those used in cancer treatment expose themselves to the risk of exposure to these drugs, which can create hazards in the medical environment. Unintended chemotherapy exposure can affect the nervous system, damage the reproductive system, and lead to an increased risk of developing hematological cancer in the future. Certain drugs must be dissolved or diluted before administration, which involves transferring a solvent from one container via a needle into a sealed vial containing the drug in powder or liquid form. If any pressure difference exists between the interior of the vial and the surrounding atmosphere, the drug may be inadvertently released into the atmosphere in gaseous form or through aerosolization during withdrawal of the needle from the vial and while the needle is inside the vial. To reduce the risk of exposure of medical providers to toxic drugs, the transfer of these drugs is achieved by utilizing closed system transfer devices or systems. [Summary of the Invention]

[0004] In one embodiment, the infusion system includes a first elastomer pump including a first reservoir and a first lumen, a second elastomer pump including a second reservoir and a second lumen, a third elastomer pump including a third reservoir and a third lumen, a switch that fluid-communicates 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 movable between a first position in which the first lumen is fluid-communicated with the patient connector and the second and third lumens are isolated from the patient connector, a second position in which the second lumen is fluid-communicated with the patient connector and the first and third lumens are isolated from the patient connector, and a third position in which the third lumen is fluid-communicated with the patient connector and the first and second lumens are isolated from the patient connector. [Brief explanation of the drawing]

[0005] The above and other features and advantages of this disclosure, as well as the methods for achieving them, will become clearer and the disclosure itself will be better understood by referring to the following description of embodiments of this disclosure taken in conjunction with the accompanying drawings. [Figure 1] Figure 1 is a perspective view of an infusion system according to one aspect or embodiment of the present application. [Figure 2] Figure 2 is a partial perspective view of the system shown in Figure 1. [Figure 3] Figure 3 is a perspective view of an infusion system according to another aspect or embodiment of the present application. [Modes for carrying out the invention]

[0006] Corresponding reference numerals indicate corresponding parts through some of the figures. The embodiments described herein illustrate exemplary aspects of the disclosure and should not be construed as limiting the scope of the disclosure in any way.

[0007] The following description is provided to enable those skilled in the art to create and use the described embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutes will remain readily apparent to those skilled in the art. Any such modifications, variations, equivalents, and substitutes are intended to be within the spirit and scope of the invention.

[0008] For the purposes of the following description, the terms “up,” “down,” “right,” “left,” “vertical,” “horizontal,” “up,” “down,” “side,” “vertical,” and their derivatives shall be used in reference to the present invention as oriented in the drawings. However, it should be understood that the present invention may envision various alternative modifications unless expressly otherwise specified. It should also be understood that certain devices shown in the accompanying drawings and described in the following specification are merely illustrative embodiments of the present invention. Therefore, certain dimensions and other physical characteristics relating to the embodiments disclosed herein should not be considered limiting.

[0009] Unless otherwise indicated, all ranges or ratios disclosed herein should be understood to include the starting and ending values, as well as any subranges or subratios contained therein. For example, the range or ratio "1 to 10" should be considered to include all subranges or subratios between (and including) the minimum value of 1 and the maximum value of 10; that is, all subranges or subratios that begin with a minimum value greater than or equal to 1 and end with a maximum value less than or equal to 10.

[0010] Terms such as "first," "second," etc., are not intended to refer to a specific order or time period, but rather to different conditions, characteristics, or elements.

[0011] As used herein, “at least one” is synonymous with “one or more.” For example, the phrase “at least one of A, B, and C” means one of A, B, or C, or any combination of two or more of A, B, or C. For example, “at least one of A, B, and C” includes one or more A alone; or one or more B alone; or one or more C alone; or one or more A and one or more B; or one or more A and one or more C; or one or more B and one or more C; or one or more of all of A, B, and C.

[0012] In one aspect or embodiment of the present application, the infusion system 10 is movable between a first elastomer pump 12 having a first reservoir 14 and a first lumen 16, a second elastomer pump 22 having a second reservoir 24 and a second lumen 26, a third elastomer pump 32 having a third reservoir 34 and a third lumen 36, a switch 40 that is 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 movable between a first position in which 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 in which 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 in which 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. Three elastomer pumps 12, 22, and 32 are shown, but two or more elastomer pumps may be provided. The infusion system 10 may be a single-use portable infusion system. In one aspect or embodiment, the infusion system 10 is configured to deliver a chemotherapeutic drug or treatment.

[0013] In one aspect or embodiment, a first reservoir 14 receives a chemotherapeutic drug, a second reservoir 24 receives heparin, and a third reservoir 34 receives saline. The system 10 is configured to provide saline flushing and heparin locking of the chemotherapy infusion set and port without disrupting the infusion line, thereby simplifying the infusion "withdrawal" process and allowing the patient to remove their line without a clinician visit. A switch 40 is configured to be manually operated by the patient or clinician to control the flow of three elastomer pumps 12, 22, and 32 for different infusion steps. The switch 40 may also include a fourth position in which the first, second, and third lumens 16, 26, and 36 are isolated from the patient connector 42.

[0014] In one embodiment, an input valve 50 is positioned between a patient connector 42 and a switch 40, and the input valve 50 has a medical connector interface 52. The input valve 50 is movable between a first position in which the medical connector interface 52 is in fluid communication with the switch 40, a second position in which the medical connector interface 52 is in fluid communication with the patient connector 42, and a third position in which 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 movable valve actuator for moving the input valve 50 between the first, second, and third positions. In one embodiment, the medical connector interface 52 is a closed female luer. In one embodiment, the medical connector interface 52 is a closed male luer of Texium®, commercially available from Becton, Dickinson and Company. The input valve 50 may be used to load reservoirs 14, 24, 34 of three elastomer pumps 12, 22, 32.

[0015] In one aspect or embodiment, the system 10 includes a manifold 60 positioned between an input valve 50 and a switch 40, the manifold 60 including an output lumen 62 that receives first, second, and third lumens 16, 26, 36 and is in fluid communication with the input valve 50.

[0016] In one embodiment, the first lumen 16 has a smaller diameter than the second and third lumen 26, 36. The sizes of the lumen 16, 26, 36 can be selected to provide optimal infusion rates for the three injectors, such as slower infusion for chemotherapeutic drugs and faster infusion for lavage and heparin. The volume of the first reservoir 14 available for chemotherapeutic drugs can be larger than the volumes of the second and third reservoirs 24, 34 available for saline and heparin.

[0017] In one aspect or embodiment, the switch 40 is color-coded with a color corresponding to each of the three positions of the switch 40 in order to provide a color indicator of the position of the switch 40. Furthermore, the elastomer pumps 12, 22, 32, which include at least a portion of the lumens 16, 26, 36, can be enclosed by an outer layer or casing 70.

[0018] Referring to Figure 3, an injection system according to further aspects or one embodiment of the present application is shown. Although not shown in Figure 3, the first, second, and third lumens 16, 26, and 36 described above may be replaced by a two-channel co-extruded tube, one small tube, and one larger tube. The two-channel co-extruded tube may be two tubes arranged adjacent to each other and bonded together along one edge. Saline and heparin flush may share the same larger lumen tube. The switch still accesses only one of the three reservoirs at a time, but two of the switch positions lead to the same downstream lumen. Although not shown in Figure 3, two larger lines are merged to the left of the dial switch.

[0019] While this disclosure has been described as having exemplary designs, it can be further modified within its spirit and scope. Therefore, this application is intended to cover any variations, uses, or adaptations of this disclosure using its general principles. Furthermore, this application is intended to cover any deviations from this disclosure that fall within the scope of known or customary practices in the relevant art and within the scope of the appended claims. Wherever possible, one or more features of any aspect or embodiment described above can be combined with one or more features of any other aspect or embodiment.

Claims

1. A first elastomer pump including a first reservoir and a first lumen, A second elastomer pump including a second reservoir and a second lumen, A third elastomer pump including a third reservoir and a third lumen, A switch that is in fluid communication with the first lumen, the second lumen, and the third lumen, A patient connector configured to be connected to a patient catheter or infusion line, wherein the switch is movable between a first position in which the first lumen is in fluid communication with the patient connector and the second and third lumenes are isolated from the patient connector, a second position in which the second lumen is in fluid communication with the patient connector and the first and third lumenes are isolated from the patient connector, and a third position in which the third lumen is in fluid communication with the patient connector and the first and second lumenes are isolated from the patient connector. A system equipped with these features.

2. The system according to claim 1, further comprising an input valve disposed between the patient connector and the switch, wherein the input valve comprises a medical connector interface, and the input valve is movable between a first position in which the medical connector interface is in fluid communication with the switch, a second position in which the medical connector interface is in fluid communication with the patient connector, and a third position in which the medical connector interface is isolated from the patient connector and the switch.

3. The system according to claim 2, further comprising a manifold disposed between the input valve and the switch, wherein the manifold includes an output lumen that receives the first, second, and third lumens and is in fluid communication with the input valve.

4. The system according to claim 1, wherein the first lumen has a diameter smaller than the diameters of the second lumen and the third lumen.

5. The system according to claim 1, wherein the first reservoir has a larger volume than the volumes of the second reservoir and the third reservoir.

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