Patent Application
20230364336
This disclosure is related to transferring infusion liquid, such as from a storage reservoir to a portable reservoir of a wearable infusion device.
Infusion devices are used to control delivery of medication directly into a patient’s bloodstream. In some cases, the delivery of medication from an infusion device is slow and continuous. This can be useful, for example, to maintain a steady concentration of medication in a patient’s bloodstream over many hours or days. Infusion devices can also respond quickly (e.g., in near real time) to biometric information from associated sensors. A common use for infusion devices is in the treatment of diabetes. Many patients with diabetes benefit from frequent or continuous infusion of insulin. This need can be temporary, such as during a hospital admission, or long-term. In the latter case, wearable infusion devices can enable a patient to receive necessary insulin infusion therapy while maintaining an active lifestyle. Wearable infusion devices typically include a battery-powered pump, a reservoir, and a cannula. The cannula is maintained in a transcutaneous position at an infusion site, such as under an adhesive patch applied directly to a patient’s skin. In some cases, the pump and reservoir are in a separate unit flexibly tethered to the cannula. This unit, for example, can be strapped to a patient or attached to a patient’s clothing. Alternatively, the pump and reservoir can be integrated with the cannula into a single unit configured to be directly attached to a patient’s skin at an infusion site.
Without modern infusion devices, management of diabetes and other conditions that require continuous or frequent infusion of medication would be far more problematic. For example, many patients suffering from diabetes have difficulty actively monitoring their need for insulin (e.g., by performing blood glucose tests) and responding to this need appropriately (e.g., by self-administering appropriate quantities of insulin). Without assistance, these patients can be subject to a significant, ongoing risk of serious complications including diabetic coma and death. Even when active disease management is within a patient’s capabilities, it can be time-consuming and stressful. Infusion devices, therefore, not only save lives, they meaningfully improve the quality of life for patients with diabetes and other diseases. Given that diabetes affects hundreds of millions of people worldwide and is only one example of a disease that often requires continuous or frequent infusion of medication, the importance of infusion devices is difficult to overstate. Accordingly, there is an ongoing need for improvement of these devices. Even small improvements in this field can have major public health benefits.
A transferring and conditioning device in accordance with at least some embodiments of the present technology includes a port through which the transferring and conditioning device is configured to receive and dispense liquid and a container at which the transferring and conditioning device is configured to hold liquid received via the port. The transferring and conditioning device also includes a flowpath extending between the port and the container and a hub at the flowpath. The hub includes a first passage, and a second passage in parallel with the first passage. The transferring and conditioning device further includes a conditioner at the first passage. The conditioner is configured to condition liquid moving between the port and the container via the first passage. The transferring and conditioning device still further includes a check valve at the second passage. The check valve is configured to cause liquid moving between the port and the container in a first direction to move preferentially via the first passage. The check valve is also configured to cause liquid moving between the port and the container in a second direction to move preferentially via the second passage, the second direction being opposite to the first direction.
An infusion system in accordance with at least some embodiments of the present technology includes a reservoir configured to contain infusion liquid and an infuser configured to deliver infusion liquid to a patient. The infusion system also includes a transferring and conditioning device configured to transfer infusion liquid from the reservoir to the infuser and to condition infusion liquid. The transferring and conditioning device includes a port through which the transferring and conditioning device is configured to receive infusion liquid from the reservoir and to dispense infusion liquid to the infuser and a container at which the transferring and conditioning device is configured to hold infusion liquid received via the port. The transferring and conditioning device also includes a flowpath extending between the port and the container and a conditioner at the flowpath. The conditioner is configured to condition infusion liquid moving between the port and the container.
A method for transferring and conditioning insulin solution in accordance with at least some embodiments of the present technology includes flowing insulin solution from a reservoir into a transferring and conditioning device. The method further includes flowing insulin solution from the transferring and conditioning device into an infuser. The method still further includes conditioning insulin solution at a conditioner of the transferring and conditioning device. The conditioning can be while flowing insulin solution from the reservoir into the transferring and conditioning device and/or while flowing insulin solution from the transferring and conditioning device into the infuser.
Many aspects of the present technology can be better understood with reference to the following drawings. The relative dimensions in the drawings may be to scale with respect to some embodiments of the present technology. With respect to other embodiments, the drawings may not be to scale. The drawings may also be enlarged arbitrarily. For clarity, reference-number labels for analogous components or features may be omitted when the appropriate reference-number labels for such analogous components or features are clear in the context of the specification and all of the drawings considered together. Furthermore, the same reference numbers may be used to identify analogous components or features in multiple described embodiments.
Devices for transferring and conditioning infusion liquid and related devices, systems, and methods in accordance with embodiments of the present technology at least partially address one or more problems associated with conventional technologies whether or not such problems are stated herein. Transferring and conditioning devices in accordance with at least some embodiments of the present technology include innovative features for prolonging the viability of infusion sites and thereby decreasing the need for creating new infusion sites. For example, these transferring and conditioning devices can condition infusion liquids and thereby reduce a tendency of the infusion liquids to promote inflammation, granulation, scarring, and/or other processes that tend to shorten infusion site viability. This conditioning can be in addition to or in place of conditioning closer in time to introduction of infusion liquid into a patient’s bloodstream. For example, in methods for transferring and conditioning infusion liquid in accordance with some embodiments of the present technology, all conditioning occurs while transferring infusion liquid from a storage reservoir to an infuser. In other embodiments, some conditioning (e.g., rough conditioning) occurs at this stage whereas other conditioning (e.g., polish conditioning) occurs at the infuser. Conditioning at the infuser, for example, can occur as infusion liquid moves from a portable reservoir of the infuser to a transcutaneous cannula.
Infusion liquid held in a storage container may develop impurities, become contaminated, or otherwise degrade over time so as to become less compatible with prolonged infusion site viability. The rate at which this degradation occurs can be difficult to predict at least in part because it can depend on variable storage conditions, such as exposure to light, air, heat, and/or cold. Transferring and conditioning devices in accordance with at least some embodiments of the present technology remove material (e.g., an impurity) from and/or add material (e.g., a drug) to infusion liquid to counter at least some storage-related degradation and/or other degradation. In addition or alternatively, the conditioning can have other beneficial effects unrelated to degradation. For example, infusion liquid sometimes includes a preservative intended to reduce storage-related degradation. In the case of insulin solution, common preservatives include phenol and meta-cresol. These and other preservatives can be irritants that shorten infusion site viability and/or have other adverse effects. Conditioning in accordance with at least some embodiments of the present technology lowers a concentration of preservative in infusion liquid, thereby prolonging infusion site viability and/or having other beneficial effects. In these and other cases, it can be advantageous for conditioning to occur close in time with infusion, such as just before adding the infusion liquid to an infusion device, which will then be infused over the next several days (e.g., within 3, 5, or 10 days of infusion). Conditioning close in time with infusion may help to reduce the effect of subsequent degradation of the infusion liquid, which may occur relatively quickly when conditioning includes removing a preservative from the infusion liquid. In addition or alternatively, conditioning close in time with infusion may help to maintain the efficacy of any short-lived additives introduced during conditioning. In other cases, the beneficial effect of conditioning on infusion liquid can be more persistent.
Specific details of several embodiments of the present technology are disclosed herein with reference to
In at least some cases, the infuser 106 is portable. For example, the infuser 106 can be wearable and can include a battery (not shown) that powers the pump 122. In other cases, the infuser 106 can be stationary. For example, a counterpart of the main unit 114 can be a bedside device for use in a hospital or home-care setting. When the infuser 106 is portable and in other cases, the tank 120 can have a capacity smaller than a capacity of the reservoir 102. Accordingly, it can be useful to transfer infusion liquid 104 from the reservoir 102 to the infuser 106 via the transferring and conditioning device 108 to replenish the tank 120 as needed. It can also be useful to transfer infusion liquid 104 from the reservoir 102 to the infuser 106 via the transferring and conditioning device 108 for other reasons, such as to initially fill the tank 120 or to change out the contents of the tank 120. To facilitate the occasional introduction of infusion liquid 104 into the tank 120, the main unit 114 can include an inlet 128 and a flowpath 130 extending between the inlet 128 and the tank 120. In other embodiments, the tank 120 may be a replaceable cartridge that is filled separately and inserted into the infuser 106.
The transferring and conditioning device 108 is further discussed below in detail with reference to
The transferring and conditioning device 108 can be handheld. Relatedly, the container 134 can have a relatively small maximum capacity, such as a maximum capacity within a range from 0.05 to 100 ml or from 0.05 to 50 ml. Furthermore, the container 134 can be elongate, cylindrical, and axially aligned with the hub 136 and the port 132. In the illustrated embodiment, the transferring and conditioning device 108 has the general form of a syringe. The transferring and conditioning device 108 is configured such that a user of the transferring and conditioning device 108 can hold the container 134 in one hand and pull the plunger 140 with the other hand to draw liquid into the container 134 via the port 132. Using one hand or two, the user can then push the plunger 140 to move liquid out of the container 134 via the hub 136 and the port 132. The grip 142 can be used to stabilize the transferring and conditioning device 108 during these operations. In other embodiments, the transferring and conditioning device 108 can have other suitable forms, sizes, and/or operational features.
The hub 136 can define a first passage 154 and a second passage 156 in parallel with the first passage 154. The hub 136 can be configured, for example, such that an unseparated quantity of liquid can flow between the container 134 and the port 132 via the first passage 154 or alternatively via the second passage 156. The transferring and conditioning device 108 can include a conditioner 158 at the first passage 154 and a check valve 160 at the second passage 156. The conditioner 158 can be configured to condition liquid moving between the container 134 and the port 132 and via the first passage 154. In the illustrated embodiment, the check valve 160 is an elastomeric duckbill valve. In other embodiments, counterparts of the check valve 160 can have other suitable forms. For example, a counterpart of the check valve 160 can be a diaphragm valve, a butterfly valve, or a ball valve. These and other suitable types of check valves can be spring-assisted or passive.
The check valve 160 can be configured to permit or inhibit flow of liquid through the second passage 156 depending on a direction of the flow. In contrast, flow across the conditioner 158 can be relatively independent of direction. A pressure drop across the conditioner 158 with respect to liquid flowing from the port 132 to the container 134 via the first passage 154 can be significantly greater (e.g., over five times greater) than a pressure drop across the check valve 160 with respect to liquid flowing from the port 132 to the container 134 via the second passage 156. Accordingly, the transferring and conditioning device 108 can be configured such that sliding the plunger 140 away from the hub 136 moves liquid from the port 132 to the container 134 preferentially via the second passage 156. In contrast, a pressure drop across the conditioner 158 with respect to liquid flowing from the container 134 to the port 132 via the first passage 154 can be significantly lower (e.g., over five times lower) than a backflow burst pressure of the check valve 160. Accordingly, the transferring and conditioning device 108 can be configured such that sliding the plunger 140 toward the hub 136 moves liquid from the container 134 to the port 132 preferentially via the first passage 154.
As shown in
The conditioner 158 can include one, two, three, or more conditioning stages. For example, as most clearly shown in
In some cases, the conditioner 158 is configured to condition insulin solution. Such conditioning can be useful, for example, to prolong infusion site viability and thereby decrease the need for creating new infusion sites. For example, conditioning insulin solution at the conditioner 158 can reduce a tendency of insulin solution to promote inflammation, granulation, scarring, and/or other processes that tend to shorten infusion site viability. The conditioner 158 can be configured to remove material from, add material to, or otherwise change the properties of insulin solution. Examples of material that can be removed from insulin solution at the conditioner 158 include air, aggregates (e.g., amyloid fibrils), and contaminants (e.g., dust). Examples of material that can be added to insulin solution at the conditioner 158 include anticoagulants (e.g., heparin), anti-inflammatories, and other drugs that can reduce inflammation, granulation, scarring, and/or other processes that tend to shorten infusion site viability.
As shown in
As also shown in
With reference to
The method 200 can further include conditioning infusion liquid 104 at the conditioner 158 (block 204). The conditioning can occur while flowing infusion liquid 104 from the reservoir 102 into the transferring and conditioning device 108, such as while flowing infusion liquid 104 from the reservoir 102 into the container 134 via the port 132. Alternatively or in addition, the conditioning can occur while flowing infusion liquid 104 from the transferring and conditioning device 108 to the infuser 106, such as while flowing infusion liquid 104 from the container 134 to the infuser 106 via the port 132. For example, in a counterpart of the transferring and conditioning device 108, the orientation of the check valve 160 can be reversed. Conditioning infusion liquid 104 can include flowing infusion liquid 104 through the mechanical filter 186 and/or through an adsorbent filter (e.g., the annular plugs 184). When the infusion liquid 104 is insulin solution and in other cases, conditioning the infusion liquid 104 can include removing air, removing aggregates, removing preservative, and/or releasing a drug.
Next, the method 200 can include flowing infusion liquid 104 from the transferring and conditioning device 108 into the infuser 106 (block 206) and finally infusing infusion liquid 104 into the patient 112 (block 208). When the infusion liquid 104 is insulin solution and in other cases, infusing the infusion liquid 104 can occur relatively soon after conditioning the infusion liquid (e.g., within 6 days, within 8 days, or within 10 days). In some cases, a given quantity of infusion liquid 104 is conditioned both at the transferring and conditioning device 108 and at the infuser 106. For example, conditioning at the transferring and conditioning device 108 can be of a type (e.g., removing aggregates) that has a longer duration of effectiveness, whereas conditioning at the infuser 106 can be of a type (e.g., removing air) that has a shorter duration of effectiveness. In other cases, conditioning occurs at the transferring and conditioning device 108 and does not occur at the infuser 106. Conditioning a quantity of infusion liquid 104 (e.g., insulin solution) at the transferring and conditioning device 108 can meaningfully increase a viability of the infusion site 126 relative to a control in which a corresponding quantity of infusion liquid 104 is not conditioned. The period of increase, for example, can be at least one day, such as within a range from one to three days. For example, increasing the use of an infusion site from three days to five days decreases the number of infusion site changes from 121 times a year to 73 times a year (48 less infusion site changes per year). That translates to, in the case of a tethered insulin infusion pump, 48 less infusion sets used, which is a benefit to the patient both in convenience and cost, and a benefit to the environment of less infusion sets disposed.
This disclosure is not intended to be exhaustive or to limit the present technology to the precise forms disclosed herein. Although specific embodiments are disclosed herein for illustrative purposes, various equivalent modifications are possible without deviating from the present technology, as those of ordinary skill in the relevant art will recognize. In some cases, well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present technology. Although steps of methods may be presented herein in a particular order, in alternative embodiments the steps may have another suitable order. Similarly, certain aspects of the present technology disclosed in the context of particular embodiments can be combined or eliminated in other embodiments. Furthermore, while advantages associated with certain embodiments may be disclosed herein in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages or other advantages disclosed herein to fall within the scope of the present technology. This disclosure and the associated technology can encompass other embodiments not expressly shown or described herein.
Throughout this disclosure, the singular terms “a,” “an,” and “the” include plural referents unless the context clearly indicates otherwise. Similarly, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the terms “comprising,” “including,” and the like are used throughout this disclosure to mean including at least the recited feature(s) such that any greater number of the same feature(s) and/or one or more additional types of features are not precluded. Directional terms, such as “upper,” “lower,” “front,” “back,” “vertical,” and “horizontal,” may be used herein to express and clarify the relationship between various structures. It should be understood that such terms do not denote absolute orientation. Furthermore, reference herein to “one embodiment,” “an embodiment,” or similar phrases means that a particular feature, structure, operation, or characteristic described in connection with such phrases can be included in at least one embodiment of the present technology. Thus, such phrases as used herein are not necessarily all referring to the same embodiment. Finally, it should be noted that various particular features, structures, operations, and characteristics of the embodiments described herein may be combined in any suitable manner in additional embodiments in accordance with the present technology.
