This disclosure relates generally to the medical field and, more specifically, medical devices.
Many medications and medicinal compounds are administered to patients parenterally. Oftentimes, the medicinal compounds are packaged separately from an intended delivery system (e.g., a medical bag). Components of medicinal compounds (e.g., medications, infusion solution, etc.) are often packaged separately. Components of medicinal compounds are often packaged separately to aid in maintaining the stability of the components of the medicinal compounds, reduce the complexity of the medicinal compounds and delivery systems, and decrease the volume of inventories materials. The components can be packaged, for example, in prefilled syringes, vials, ampuls, and large volume infusion solutions.
In use, the contents of one or more packages (e.g., prefilled syringes, vials, etc.) are combined in a medical bag. The mixing of the components (e.g., the medications infusion solutions, etc.) can occur in a pharmacy (e.g., in a medical facility, such as a hospital), at the point-of-care, in an outpatient facility, and/or during emergency transport.
A variety of approaches, and associated devices, currently exist for combining the components and readying the delivery system. One such approach includes a mating or transfer device that connects a packaging (e.g., a vial) with a medical bag. Another approach is the use of an adapter affixed to a needleless syringe in which the adapter mates with the medical bag. A third approach utilizes proprietary packaging and medical bags (i.e., packaging, such as syringes or vials and medical bags that utilize proprietary connectors).
While each of these approaches can be used to successfully combining the components and readying the delivery system, each has drawbacks. For example, use of a mating or transfer device, or an adapter and a needleless syringe, requires additional inventory. That is, medical providers (e.g., hospitals, medical offices, emergency vehicles, etc.) must maintain an inventory of the mating or transfer devices, adaptors, and/or needleless syringes. The use of proprietary packaging and medical bags requires medical providers to purchase and include in inventory such proprietary packaging and medical bags.
Further, the current approaches typically require that the entire quantity of the packaging be combined in the delivery system. For example, the current devices do not allow for a user to easily administer only a portion of the quantity of the packaging in a controlled manner. Additionally, the current approaches do not have a mechanism for quickly confirming that the contents of the packaging have been added to the delivery system.
Accordingly, a need exists for medical devices that can accurately deliver the correct quantity of medication while minimizing the risks of misadministration of the medication in a convenient and cost-effective manner.
Disclosed herein are embodiments of systems, apparatuses, and methods pertaining medical devices. This description includes drawings, wherein:
Elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions and/or relative positioning of some of the elements in the figures may be exaggerated relative to other elements to help to improve understanding of various embodiments of the present disclosure. Also, common but well-understood elements that are useful or necessary in a commercially feasible embodiment are often not depicted in order to facilitate a less obstructed view of these various embodiments of the present disclosure.
Generally speaking, pursuant to various embodiments, systems, apparatuses and methods are provided herein pertaining to medical devices. In some embodiments, a medical device comprises a main body portion, the main body portion comprising a medication dispenser, a connection portion, wherein the connection portion is secured to a top of the main body portion, the connection portion comprising a needle, wherein the needle is located within a housing, and wherein the needle is communicatively coupled to the medication dispenser, the housing, wherein the housing includes a needle guard, wherein an upper surface of the needle guard extends beyond the needle, and a cover, wherein the cover is configured to seat on the connection portion, the cover comprising an outer cover, and an inner cover, wherein the inner cover is configured to seat on the needle, and wherein the inner cover and the outer cover form a single structure.
As previously discussed, precision can be critically important in the medical field, for example, with respect to medication dosage and delivery. One area in which precision is critical is in the administration of medication. While some medications are administered orally, others are administered via medical devices, such as syringes. These medications can be delivered directly to the patient (e.g., intravenously) or indirectly to the patient (e.g., via a medical bag). Typically, medications that are delivered indirectly to patients are of a higher concentration than those delivered directly and thus are diluted (in the case of liquids) or reconstituted (in the case of powders) before they reach the patient. Because medications that are delivered indirectly to patients are typically of a higher concentration, such medications should not be administered directly to a patient. Though this is known, situations arise in which a medication of a high concentration may be inadvertently delivered to a patient directly. Currently systems exist that help avoid such inadvertent delivery of highly concentrated medication. However, these systems typically utilize proprietary connectors. Such proprietary connectors are undesirable, as the use of such proprietary connectors may force a healthcare facility, or system, to adopt only a single style of medical equipment that includes, or is adapted to work with, the proprietary connectors. This can be costly for a healthcare facility, or system, and result in funds being used to purchase proprietary equipment which could be otherwise used on patient care.
Described herein are systems, methods, and apparatuses that seek to minimize, if not eliminate, these drawbacks. In one embodiment, a medical device is provided that can be used for concentrated medications and does not require a proprietary connector. For example, such medical devices can be used with generic medical bags to administer concentrated medication to a patient via the generic medical bag. Additionally, in some embodiments, the medical device includes mechanisms by which inadvertent direct administration of concentrated medications can be avoided. For example, in one embodiment, the medical device includes a needle guard that would make direct administration of a medication contained in the medical device difficult and/or inconvenient. Additionally, the medical devices described herein can be used with generic medical bags, minimizing or eliminating the need for healthcare facilities, and systems, to adopt only a single style of medical equipment that includes, or is adapted to work with, proprietary medical devices. The discussion of
In the example depicted in
As previously discussed, in some embodiments, the medical bag 104 is a generic medical bag. Because the medical device 110 includes a needle 108 that is communicatively coupled to the medication dispenser, the medical device 110 can interface with a generic medical bag to administer fluid contained in the medication dispenser into the medical bag 104 via the needle 108. That is, due to the design of the connection portion, a proprietary or special medical bag is not required for use with the medical device 110. Such systems can be advantageous in that they do not require healthcare facilities, or systems, to adopt only a single style or brand of medical equipment, resulting in potential cost savings and convenience for the healthcare facilities, or systems.
While the discussion of
The connection portion 210 generally comprises the needle 202 and a housing 206. The needle 202 is located within the housing 206 and communicatively coupled to the medication dispenser 222. The housing 206 includes a needle guard 208. In one embodiment, an upper surface of the needle guard 208 extends beyond the needle 202. In such embodiments, the needle guard 208 can aid in preventing needle sticks and/or inadvertent direct administration of the contents of the medication dispenser 222. The needle guard 208 can be made of any suitable material (e.g., rubber, plastic, etc.) and be dimensioned as desired to aid in preventing needle sticks and/or inadvertent direct administration of the contents of the medication dispenser 222. In some embodiments, the connection portion 210 includes a mating mechanism 224. In such embodiments, the mating mechanism 224 can mate with a corresponding feature of a medical bag to secure the medical device 200 to the medical bag. The mating mechanism 224 can take any suitable form. In one embodiment, the mating mechanism is configured such that the medical device 200 can mate with a generic medical bag and/or a large variety of medical bags, minimizing or eliminating the need for a healthcare facility, or system, to adopt only a single style of medical equipment. Alternatively, the mating mechanism 224 can take a specialized form, such that the medical device 200 is configured to mate with a specific type and/or brand of medical bag.
The cover 220 generally comprises an outer cover 204 and an inner cover 226. The outer cover 204 is configured to seat on the connection portion 210 and cover at least a portion of the connection portion 210. In some embodiments, the outer cover 204 is secured to the connection portion 210. For example, the outer cover 204 and/or connection portion 210 can include fasteners (e.g., clips, detents, rings, etc.) that secure the outer cover 204 to the connection portion 210. Additionally, or alternatively, the outer cover 204 and/or connection portion 210 can be dimensioned such that the outer cover 204 is secured to the connection portion 210 via a friction fit. The inner cover 226 is configured to cover at least a portion of the needle 202. In one embodiment, the outer cover 204 and the inner cover 226 form a single structure. In such embodiments, the inner cover 226 may be integral to the outer cover 204 such that removal of the outer cover 204 causes removal of the inner cover 226. The outer cover 204 and the inner cover 226 can be made of any suitable material (e.g., plastic, rubber, etc.) and need not be made of the same material. For example, in one embodiment, the outer cover 204 can be made of plastic and the inner cover 226 can be made of rubber that is molded, or otherwise integrated, into the outer cover 204.
In some embodiments, the medical device 200 includes a plunger. The plunger includes the plunger rod 218 and the stopper 216. The plunger is manipulable from a first position (e.g., an undispensed position) and a second position (e.g., a dispensed position). When in the second position, at least a portion of the fluid contained in the medication dispenser 222 has been expressed via the needle 202. In some embodiments, the stopper 216 is detachably affixed to the plunger rod 218. For example, the stopper 216 can be affixed to the plunger rod 218 via a press-fit, via threads on one or more of the stopper 216 and the plunger rod 218, via one or more fasteners, etc. In such embodiments, the plunger rod 218 can be easily removed from the stopper 216 once the fluid contained in the medication dispenser 222 has been expressed. As previously discussed, in some embodiments, the medication dispenser 222 includes a stopper retention 212 that engages the stopper 216. The stopper retention 212 can secure the stopper 216 in the dispensed position. In embodiments where the stopper 216 is detachably affixed to the plunger rod 218, once the stopper retention 212 has secured the stopper 216 in the dispensed position, the plunger rod 218 can be removed from the stopper 216. Such embodiments may allow people, such as healthcare workers, to quickly and easily verify that the contents of the medication dispenser 222 have been expressed. Additionally, removal of the plunger rod 218 may allow more space for healthcare workers to perform their tasks as well as prevent inadvertent manipulation of the stopper from the dispensed position.
While the discussion of
In the example depicted in
While the discussion of
The connection portion 422 generally comprises the needle 404 and a housing 424. The needle 404 is communicatively coupled to the medication dispenser. That is, the fluid contained in the medication dispenser can be expressed via the needle 404. The housing 424 includes a needle guard 410. In one embodiment, an upper surface of the needle guard 410 extends beyond the needle 404. In such embodiments, the needle guard 410 can aid in preventing needle sticks and/or inadvertent direct administration of the contents of the medication dispenser. The needle guard 410 can be made of any suitable material (e.g., rubber, plastic, etc.) and be dimensioned as desired to aid in preventing needle stick and/or inadvertent direct administration of the contents of the medication dispenser. In some embodiments, the connection portion 422 includes a mating mechanism 412. In such embodiments, the mating mechanism 412 can mate with a corresponding feature of a medical bag to secure the medical device 400 to the medical bag. The mating mechanism 412 can take any suitable form. In one embodiment, the mating mechanism 412 is configured such that the medical device 400 can mate with a generic medical bag and/or a large variety of medical bags. Such systems can be advantageous in that they do not require healthcare facilities, or systems, to adopt only a single style or brand of medical equipment, resulting in potential cost savings and convenience for the healthcare facilities, or systems. Alternatively, the mating mechanism 412 can take a specialized form, such that the medical device 400 is configured to mate with a specific type and/or brand of medical bag. As depicted in
The cover 402 generally comprises an outer cover 408 and an inner cover 406. The outer cover 408 is configured to seat on the connection portion 422 and cover at least a portion of the connection portion 422. In some embodiments, the outer cover 408 is secured to the connection portion 422. For example, the outer cover 408 and/or connection portion 422 can include fasteners (e.g., clips, detents, rings, etc.) that secure the outer cover 408 to the connection portion 422. Additionally, or alternatively, the outer cover 408 and/or connection portion 422 can be dimensioned such that the outer cover 408 is secured to the connection portion 422 via a friction fit. The inner cover 406 is configured to cover at least a portion of the needle 404. In one embodiment, the outer cover 408 and the inner cover 406 form a single structure. In such embodiments, the inner cover 406 may be integral to the outer cover 408 such that removal of the outer cover 408 causes removal of the inner cover 406. The outer cover 408 and the inner cover 406 can be made of any suitable material (e.g., plastic, rubber, etc.) and need not be made of the same material. For example, in one embodiment, the outer cover 408 can be made of plastic and the inner cover 406 can be made of rubber that is molded, or otherwise integrated, into the outer cover 408.
The medical device 400 is manipulable from a first position (e.g., an undispensed position) to a second position (e.g., a dispensed position). For example, with a bellows-type medical device, the manipulation of the medical device 400 from the first position to the second position causes the medication dispenser to dispense the fluid contained in the medication dispenser. In the example provided, the medical device 400 is in the first position in
In some embodiments, a medical device comprises a main body portion, the main body portion comprising a medication dispenser, a connection portion, wherein the connection portion is secured to a top of the main body portion, the connection portion comprising a needle, wherein the needle is located within a housing, and wherein the needle is communicatively coupled to the medication dispenser, the housing, wherein the housing includes a needle guard, wherein an upper surface of the needle guard extends beyond the needle, and a cover, wherein the cover is configured to seat on the connection portion, the cover comprising an outer cover, and an inner cover, wherein the inner cover is configured to seat on the needle, and wherein the inner cover and the outer cover form a single structure.
In some embodiments, a medical device comprises a main body portion, the main body portion comprising a medication dispenser and a stopper retention, a connection portion, wherein the connection portion is secured to a top of the main body portion, the connection portion comprising a needle, wherein the needle is located within a housing, and wherein the needle is communicatively coupled to the medication dispenser, the housing wherein the housing includes a needle guard, wherein an upper surface of the needle guard extends beyond the needle, and a plunger, wherein the plunger is manipulable from a first position to a second position, wherein when manipulated from the first position to the second position medication housed in the medication dispenser is expressed via the needle, the plunger comprising a plunger rod, and a stopper, wherein the stopper is detachably affixed to the plunger rod, and wherein the stopper engages with the stopper retention when the plunger is in the second position to secure the stopper in the second position.
In some embodiments a medical system comprises a medical device, wherein the medical device comprises a main body portion, the main body portion comprising a medication dispenser, a connection portion, wherein the connection portion is secured to a top of the main body portion, the connection portion comprising a needle, wherein the needle is communicatively coupled to the medication dispenser, the housing, wherein the housing includes a needle guard, wherein an upper surface of the needle guard extends beyond the needle, and a cover, wherein the cover is configured to seat on the connection portion, the cover comprising an outer cover, and an inner cover, wherein the inner cover is configured to seat on the needle, and wherein the inner cover and the outer cover form a single structure, and a medical bag, wherein the medical bag comprises a fluid cavity, and a connector, wherein the connector is communicatively coupled to the fluid cavity, and wherein the connector is configured to mate with the connection portion of the medical device.
Those skilled in the art will recognize that a wide variety of other modifications, alterations, and combinations can also be made with respect to the above described embodiments without departing from the scope of the disclosure, and that such modifications, alterations, and combinations are to be viewed as being within the ambit of the inventive concept.