US-20260124411-A1 - ASSEMBLY FOR SECURING EXPOSED DOSE ADJUSTMENT CONTROL MECHANISMS OF MEDICAL DEVICES USED TO ADMINISTER VARIOUS MEDICAL THERAPIES

US20260124411A1US 20260124411 A1US20260124411 A1US 20260124411A1US-20260124411-A1

Abstract

An assembly and method for housing and securing exposed dose adjustment control mechanisms of medical devices used to administer various medical therapies, is provided. In an exemplary embodiment, the inventive assembly and method serve to house and secure exposed dose adjustment control mechanisms of oxygen concentrators used to provide oxygen therapy. The inventive assembly, which securely encloses a dose adjustment control mechanism, permitting access only to select individuals, is made up of a cup-shaped hollow member having a through-hole in a distal wall, and a lid. The cup-shaped hollow member and the lid are held together by a hinge or fastening means, and fastening/locking means.

Inventors

Robert Hardy

Assignees

ServiceNet, Inc.

Dates

Publication Date: 20260507
Application Date: 20251031

Claims (20)

1 . An assembly for housing and securing exposed dose adjustment control mechanisms of medical devices used to administer various medical therapies, the assembly comprising: a cup-shaped hollow member having a through-hole in a distal wall; and a lid, wherein the cup-shaped hollow member and the lid are held together by a hinge or fastening means, and fastening/locking means.
2 . The assembly of claim 1 , wherein the medical device is an oxygen therapy system.
3 . The assembly of claim 2 , wherein the oxygen therapy system is an oxygen concentrator.
4 . The assembly of claim 1 , wherein the dose adjustment control mechanism has a user-actuatable element selected from the group of a knob, a dial, or other rotary or slidable control configured to adjust an operational parameter of the medical device.
5 . The assembly of claim 1 , wherein the cup-shaped hollow member and the lid are connected by a hinge, which allows for bending of the lid from an ‘open’ position removed from the cup-shaped hollow member to a ‘closed’ position on and in alignment with the cup-shaped hollow member.
6 . The assembly of claim 5 , wherein the assembly is a two-piece assembly, and the hinge is a mechanical hinge.
7 . The assembly of claim 5 , wherein the assembly is a one-piece assembly, and the hinge is a living hinge.
8 . The assembly of claim 1 , wherein the inventive assembly is a two-piece assembly in which the cup-shaped hollow member and the lid are connected by fastening means which allow for rotation of the lid from an ‘open’ position on but misaligned from the cup-shaped hollow member to a ‘closed’ position on and in alignment with the cup-shaped hollow member.
9 . The assembly of claim 8 wherein the fastening means is a bolt with a bolt shaft, which is secured by a nut, wherein rotation of the lid occurs around or about the bolt shaft.
10 . The assembly of claim 1 , wherein the cup-shaped hollow member has an upper rim having two oppositely extending arms, at least one of which has a through-hole at a distal end thereof, a base with a lower base extension molded integrally therewith, and a through-hole extending through both the base and the base extension.
11 . The assembly of claim 10 , wherein the base extension conforms to a surface of the medical device allowing it to lie flush or level with the surface of the device.
12 . The assembly of claim 6 , wherein the cup-shaped hollow member has an upper rim having two oppositely extending arms, one of which has a through-hole at a distal end, wherein the lid has two oppositely disposed extending arms, one of which has a through-hole at a distal end thereof, wherein, when the lid is aligned with the cup-shaped hollow member, the through-holes of both the lid and the cup-shaped hollow member align, and the assembly further comprises a fastening/locking mechanism extending through the aligned through-holes.
13 . The assembly of claim 12 , wherein the fastening/locking mechanism is selected from the group of keyed or combination lock devices and electronic lock devices.
14 . The assembly of claim 7 , wherein the cup-shaped hollow member has an upper rim having two oppositely extending arms, one of which has a through-hole at a distal end, wherein the lid has two oppositely disposed extending arms, one of which has a through-hole at a distal end thereof, wherein, when the lid is aligned with the cup-shaped hollow member, the through-holes of both the lid and the cup-shaped hollow member align, and the assembly further comprises a fastening/locking mechanism extending through the aligned through-holes.
15 . The assembly of claim 14 , wherein the fastening/locking mechanism is selected from the group of keyed or combination lock devices and electronic lock devices.
16 . The assembly of claim 8 , wherein the cup-shaped hollow member has an upper rim having two oppositely extending arms, each extending arm having a through-hole at a distal end thereof, wherein the lid has two oppositely disposed extending arms, each extending arm also having a through-hole at a distal end thereof, wherein, when the lid is aligned with the cup-shaped hollow member, the through-holes of both the lid and the cup-shaped hollow member align, and the fastening means extend through one set of aligned through-holes and fastening/locking means extend through the other set of aligned through-holes.
17 . The assembly of claim 16 , wherein the fastening means is a bolt secured by a nut, and wherein the fastening/locking means is selected from the group of keyed or combination lock devices and electronic lock devices.
18 . A method for housing and securing exposed dose adjustment control mechanisms of medical devices using an assembly that includes a cup-shaped hollow member having a through-hole in a distal wall, and a lid, wherein the cup-shaped hollow member and the lid are held together by a hinge or fastening means, and fastening/locking means, wherein each dose adjustment control mechanism includes a user-actuatable element, wherein the method comprises: (a) removing the user-actuatable element from a stem on a medical device used to administer various medical therapies; (b) positioning the cup-shaped hollow member's through-hole over the stem; (c) replacing the user-actuatable element by placing it back onto the stem; (d) setting a prescribed quantity of a medicine or drug using the user-actuatable element; and (e) bending or rotating the lid onto and in alignment with the cup-shaped member and then securing the lid in place on the cup-shaped hollow member, thereby preventing access to the user-actuatable element.
19 . The method of claim 18 , wherein the user-actuatable element is selected from the group of a knob, a dial, or other rotary or slidable control configured to adjust an operational parameter of the medical device.
20 . The method of claim 18 , wherein the cup-shaped hollow member and the lid of the assembly are connected by a hinge, which allows for bending of the lid from an ‘open’ position removed from the cup-shaped hollow member to a ‘closed’ position on and in alignment with the cup-shaped hollow member.

Description

CROSS-REFERENCE TO RELATED APPLICATION This application claims the benefit of priority of U.S. Provisional Patent Application Ser. No. 63/716,857, filed Nov. 6, 2024, the contents of which are herein incorporated by reference. TECHNICAL FIELD The present invention generally relates to an assembly and method for housing and securing exposed dose adjustment control mechanisms of medical devices used to administer various medical therapies, and in an exemplary embodiment relates to an assembly and method for housing and securing exposed dose adjustment control mechanisms of oxygen concentrators used to provide oxygen therapy. The term “control mechanism”, as used herein, includes a user-actuatable element, such as a knob, dial, or other rotary or slidable control configured to adjust the quantity of a medicine or drug (e.g., medical-grade oxygen) being administered by the device. BACKGROUND A number of different types of medicament dispensers for dispensing various types of medicines or drugs to patients have been suggested in the past. The type and amount of dispensed medicine or drug is set by a qualified healthcare provider. Dispensers with exposed dose adjustment control mechanisms, which can be either inadvertently or intentionally altered, present a risk to the patient. One such medicine or drug is medical-grade oxygen. Supplemental oxygen therapy is used for those who frequently experience low oxygen levels including people with COPD, COVID-19, emphysema, sleep apnea and other breathing problems. Low blood oxygen levels (hypoxemia) can damage organs and be life-threatening. There are several types of oxygen therapy systems, which may be large and stationary for home use, or small and portable. One such oxygen therapy system is an oxygen concentrator. Oxygen concentrators are devices that remove nitrogen and other gases from air and deliver purified oxygen to a user. Oxygen concentrators are recognized as the easiest portable system to travel with. As alluded to above, medical-grade oxygen is a medicament or medication and requires a prescription from a qualified healthcare provider. They will prescribe oxygen at a specific flow rate to use at rest, during activity, and during sleep. Once the prescribed flow rate is set on an oxygen concentrator, intentional or accidental tampering with the set flow rate may cause health risks. Too little oxygen can put a strain on a patient's heart and brain, causing heart failure, fatigue or memory loss, while too much can cause some patients to slow their breathing to dangerously low levels. The present invention serves to address the risks caused by intentional or accidental tampering with settings on medical devices used to administer various medical therapies. SUMMARY In particular, the present invention provides an assembly for housing and securing exposed dose adjustment controls of medical devices used to administer various medical therapies. In one contemplated embodiment, the inventive assembly houses and secures exposed dose adjustment control mechanisms of oxygen concentrators used to administer oxygen therapy. Once the inventive assembly is in place on a medical device, the assembly prevents access to a dose adjustment control mechanism. The inventive assembly comprises a cup-shaped hollow member having a through-hole in a distal wall, and a lid. The cup-shaped hollow member and the lid are held together by a hinge or fastening means, and fastening/locking means. In a first exemplary embodiment, the inventive assembly is either a one-piece or a two-piece assembly, wherein the cup-shaped hollow member and the lid are connected by a hinge (e.g., a living hinge or a mechanical hinge), which allows for bending of the lid from an ‘open’ position removed from the cup-shaped hollow member to a ‘closed’ position on and in alignment with the cup-shaped hollow member. As will be explained in more detail below, once the inventive assembly is in place on a medical device, the device's dose adjustment control mechanism set, and the lid positioned to a ‘closed’ position, the lid may be secured in place by electronic fastening/locking means, or by mechanical fastening/locking means such as a lock and key. In a second exemplary embodiment, the inventive assembly is a two-piece assembly, wherein the cup-shaped hollow member and the lid are connected by fastening means (e.g., a bolt (secured by a nut)), which allows for rotation of the lid (e.g., rotation of the lid around the bolt shaft) from an ‘open’ position on but misaligned or moved away from an aligned position with the cup-shaped hollow member to a ‘closed’ position on and in alignment with the cup-shaped hollow member. As mentioned above, once the inventive assembly is in place on a medical device, the device's dose adjustment control mechanism set, and the lid positioned to a ‘closed’ position, the lid may be secured in place by electronic fastening/locking means, or by mechanical fastening/locking means such as a