“Distribution Of Infusion Pumps” in Patent Application Approval Process (USPTO 20200219174)

2020 JUL 27 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- A patent application by the inventor Estes, Mark C. (Malibu, CA), filed on March 18, 2020, was made available online on July 9, 2020, according to news reporting originating from Washington, D.C., by NewsRx correspondents.

This patent application is assigned to Bigfoot Biomedical Inc.

The following quote was obtained by the news editors from the background information supplied by the inventors: “Pump devices are commonly used to deliver one or more fluids to a targeted individual. For example, a medical infusion pump device may be used to deliver a medicine to a patient as part of a medical treatment. The medicine that is delivered by the infusion pump device can depend on the condition of the patient and the desired treatment plan. For example, infusion pump devices have been used to deliver insulin to the vasculature of diabetes patients so as to regulate blood-glucose levels.

“Some infusion pumps are provided to users as ‘durable medical equipment’ that is intended to be used for many consecutive years. As such, the upfront costs of obtaining such an infusion pump are high. In some circumstances, a user’s health insurance provider will pay a substantial portion of these upfront costs. However, the process for preauthorizing insurance coverage for an infusion pump (under the ‘durable medical equipment’ procedure) may require a substantial burden of paperwork and communications among the pump supplier, the physician who prescribes the infusion pump for the user, and the user’s health insurance provider.”

In addition to the background information obtained for this patent application, NewsRx journalists also obtained the inventor’s summary information for this patent application: “Some embodiments described herein provide for a number of portable infusion pumps to be distributed to a pump user via a pharmacy system or a like process that may impose a lower burden on the pump user when obtaining the infusion pump. In such circumstances, a pump user may simply pay a co-pay at the pharmacy window, and then take home a new supply of infusion pumps for use in dispensing a medicine (e.g., insulin or another infused medication) over a period of time. Accordingly, the paperwork burdens imposed upon the pump supplier and the physician treating the user may be reduced, and the delays associated with obtaining preauthorization for insurance coverage can also be reduced or eliminated. Furthermore, this distribution system may provide relief to health insurance providers by spreading the costs for the infusion pump usage over a longer period of time (rather than paying a large upfront cost for an infusion pump distributed as durable medical equipment).

“In particular, embodiments, a method of receiving an insulin infusion pump device can include obtaining a prescription for a supply of infusion pump devices to deliver insulin. The method may also include submitting the prescription to a pharmacy for repeated deliveries of the infusion pump devices over a predetermined period of time. The method may further include receiving a plurality of infusion pump devices from the pharmacy contemporaneously with the receipt of insulin from pharmacy.

“Some embodiments of a method of providing an insulin infusion pump device may include storing multiple infusion pump devices in a pharmacy inventory. The method may also include, in response to an individual user request to a pharmacy for repeated deliveries of infusion pump devices, distributing a plurality of infusion pump devices from the pharmacy inventory to the individual user while contemporaneously distributing insulin from the pharmacy inventory.

“In certain embodiments, a method of providing an insulin infusion pump system can include selecting a predetermined ratio of disposable and non-reusable infusion pump devices to insulin cartridges that are operable to be received in the infusion pump devices. The predetermined ratio may one infusion pump device to one insulin cartridge. The method may also include arranging disposable pump devices and insulin cartridges into a package according to the predetermined ratio. The method may further include providing the package to a requestor in response to a request.

“In some embodiments, a method providing an insulin infusion pump system may include obtaining a disposable and non-reusable infusion pump device, an insulin cartridge containing insulin, and at least one infusion set device operable to penetrate into skin. The method may also include arranging the disposable pump device, the insulin cartridge, and the at least one infusion set device into a single package. The method may further include providing the single package to a requestor in response to a request for at least the pump device.

“Some or all of the embodiments described herein may provide one or more of the following advantages: First, a pump user can receive a supply of portable infusion pumps in a manner that can reduce the time and paperwork burden for the user. For example, the individual user can receive a number of portable infusion pumps via a pharmacy system or the like so that the pump user can simply pay a relatively small fee at the pharmacy window to obtain a supply of infusion pumps. Second, the distribution of the infusion pumps via a pharmacy system may provide benefits to health insurance providers by spreading the costs for the infusion pump usage over a longer period of time. For example, each of the infusion pumps can be a low cost and disposable component, so the cost to insurers is spread out in the form of user prescription refills, as opposed to a large up front cost. By spreading the costs over a greater period of time, the health insurance provider is not necessarily exposed to a sunk cost in the form of the large upfront payment in the event that the pump user decides to no longer continue pump therapy or accidentally loses or damages the infusion pump. Third, the pharmacy distribution of the infusion pumps can reduce the substantial paperwork burdens that may otherwise be required for preauthorization of insurance coverage for an infusion pump classified as ‘durable medical equipment.’ In these circumstances, the paperwork burdens imposed upon the pump supplier and the physician treating the user may be reduced, and the delays associated with obtaining preauthorization for insurance coverage can also be reduced or eliminated. Fourth, one or more of the infusion pumps can be packaged along with an associated medicine cartridge to simply the transaction for the pump user. For example, the package may include a quantity of infusion pumps in a 1:1 ratio with the quantity of medicine cartridges. In addition, the package may include a quantity of infusion sets for use with one or more of the infusion pumps. In such circumstances, the pump user may be able to pay a single copay or other fee to receive the package containing the infusion pumps, the medicine cartridges, and other components.

“The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.”

The claims supplied by the inventors are:

“1. (canceled)

“2. An insulin infusion kit, the kit comprising: a container; a plurality of infusion pump devices disposed within the container; a plurality of insulin retention containers disposed within the container, wherein each of the insulin containers is configured to be irreversibly positioned within one of the infusion pump devices; and a plurality of infusion sets disposed within the container.

“3. The kit of claim 2, wherein the insulin retention containers are external to the infusion pump devices within the container.

“4. The kit of claim 2, wherein the insulin retention containers are physically separated from the infusion pump devices within the container.

“5. The kit of claim 2, wherein each of the plurality of infusion pump devices comprises a disposable and non-reusable infusion pump device.

“6. The kit of claim 5, wherein each of the insulin retention containers comprises a prefilled insulin cartridge sealed by a pierceable septum.

“7. The kit of claim 6, wherein each of the infusion pump devices includes a cap device configured to seal an external opening of a respective infusion pump device and configured to pierce the septum of a respective prefilled insulin cartridge after the respective prefilled insulin cartridge is slidably inserted through an external opening of the respective infusion pump device.

“8. The kit of claim 2, wherein the plurality of infusion sets are disposed within a first compartment within the container and the the infusion pump devices are disposed within a second compartment within the container, the first compartment being distinct from the second compartment.

“9. The kit of claim 2, wherein each of the infusion pump devices in the plurality of infusion pump devices is configured to removably attach to a reusable controller device such that a first electrical connector exposed along an exterior of a selected infusion pump device engages a second electrical connector exposed along an exterior of the reusable controller device.

“10. The kit of claim 2, wherein the container contains the infusion pump devices, the insulin retention containers, and the infusion sets in a predetermined ratio of 1:1:2 respectively.

“11. The kit of claim 2, wherein each of the infusion pump devices in said plurality of infusion pump devices includes a drive system comprising a rotational motor coupled to a gear system.

“12. The kit of claim 11, wherein the drive system is configured to dispense medicine from a corresponding one of said insulin retention containers.

“13. The kit of claim 2, further comprising: a sealed pouch disposed within the container, wherein the plurality of infusion sets are arranged within the sealed pouch.

“14. A kit for administering medicine, the kit comprising: a plurality of infusion pump devices; a plurality of insulin retention containers, wherein each of the insulin containers is configured to be irreversibly positioned within one of the infusion pump devices; and a plurality of infusion sets disposed within a container.

“15. The kit of claim 14, wherein each of the insulin retention containers is sealed by a pierceable septum and wherein the insulin retention containers are external to the infusion pump devices; and wherein each of the infusion pump devices includes a cap device configured to seal an external opening of a respective infusion pump device and configured to pierce the septum of a respective insulin retention container after the respective insulin retention container is slidably inserted through an external opening of the respective infusion pump device.

“16. The kit of claim 14, wherein the container contains the infusion pump devices, the insulin retention containers, and the infusion sets in a predetermined ratio of 1:1:2 respectively.

“17. A method of providing an insulin infusion pump system, comprising: arranging a plurality of disposable and non-reusable infusion pump devices, a plurality of insulin retention containers, and a plurality of infusion sets into a package according to a predetermined ratio of one infusion pump device to one insulin retention container to two infusion sets, each of the insulin retention containers configured to retain fluid insulin that may be dispensed through a respective infusion pump device of the plurality of infusion pump devices in response to activation of a drive system of the respective infusion pump device; and providing the package containing the predetermined ratio of the disposable and non-reusable infusion pump devices, the insulin retention containers, and the infusion sets to a requester in response to a request.

“18. The method of claim 17, wherein each of the infusion pump devices is configured to removably attach to a reusable controller device.

“19. The method of claim 17, wherein each of the insulin retention containers is sealed by a pierceable septum and wherein the insulin retention containers are external to the infusion pump devices when the infusion pump devices are arranged into the package; and wherein each of the infusion pump devices includes a cap device configured to seal an external opening of a respective infusion pump device and configured to pierce the septum of a respective insulin retention container when the respective insulin retention container is retained by the respective infusion pump device.

“20. The method of claim 17, wherein the plurality of infusion sets are arranged within a sealed pouch within the package when the package is presented to the requester.

“21. The method of claim 17, wherein the insulin retention containers are external to the infusion pump devices within the package when the package is presented to the requester.”

URL and more information on this patent application, see: Estes, Mark C. Distribution Of Infusion Pumps. Filed March 18, 2020 and posted July 9, 2020. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220200219174%22.PGNR.&OS=DN/20200219174&RS=DN/20200219174

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