Patent Application
20230364279
Medical consumables such as electrocardiograph (ECG) lead sets, SpO2 sensors, and blood pressure cuffs are typically available in two options: multi-patient use (i.e., reusable) and single-patient use (i.e., disposable). As the name describes, a multi-patient use consumable is used on many different patients over the lifetime of the consumable. These consumables are cleaned and/or disinfected between each use.
Typically, disinfectant wipes are used by the hospital staff for cleaning these consumables. However, this approach has certain drawbacks. For example, cleaning the consumables is time consuming and adds further duties to medical personnel daily obligations. Moreover, many consumables are difficult to clean. For example, the existence of small ridges and clamps in some ECG lead wires causes difficulty in cleaning and disinfecting the ECG lead wires thoroughly. It has for example been shown that bacteria are common on reusables, cleaned lead wires. These consumables are therefore seen as a potential source of Hospital Acquired Infections (HAI).
As an alternative, hospitals can opt for single-patient use consumables. With this type of consumables, patients always receive clean devices, which limit the risk of HAI. They are also seen as convenient since such consumables are always ready to be used and no hand cleaning is required after each use. However, the overall cost of the use of consumable devices, when compared to multi-patient use consumables is larger. Moreover, single-patient consumables can result in unacceptable increases in electronic and biohazard waste. In addition, health care facilities relying on single-patient use consumables will need to regularly restock supplies of these components, exposing the health care facilities to shortages in supply of the components, and delays in delivery by suppliers, to name only a few drawbacks.
What is needed, therefore, are medical components that overcome at least the shortcomings of known components discussed above.
According to an aspect of the present disclosure, a method of ensuring a medical connector for a medical device is disinfected, or sterilized, or both is disclosed. The method comprises: receiving the medical connector in a blocked state, wherein a component of the medical connector comprises a shape-memory alloy (SMA); and heating the medical connector to a sufficient temperature to change a shape of the SMA to an unblocked state.
According to another aspect of the present disclosure, a medical device is disclosed. The medical device comprises: a medical connector comprising a shape memory alloy (SMA) adapted to engage a mating connector in an unblocked state, wherein upon disengaging the medical connector the SMA is in a blocked state.
The representative embodiments are better understood from the following detailed description when read with the accompanying drawing figures. It is emphasized that the various features are not necessarily drawn to scale. In fact, the dimensions may be arbitrarily increased or decreased for clarity of discussion. Wherever applicable and practical, like reference numerals refer to like elements.
In the following detailed description, for the purposes of explanation and not limitation, representative embodiments disclosing specific details are set forth in order to provide a thorough understanding of an embodiment according to the present teachings. Descriptions of known systems, devices, materials, methods of operation and methods of manufacture may be omitted so as to avoid obscuring the description of the representative embodiments. Nonetheless, systems, devices, materials and methods that are within the purview of one of ordinary skill in the art are within the scope of the present teachings and may be used in accordance with the representative embodiments. It is to be understood that the terminology used herein is for purposes of describing particular embodiments only and is not intended to be limiting. The defined terms are in addition to the technical and scientific meanings of the defined terms as commonly understood and accepted in the technical field of the present teachings.
It will be understood that, although the terms first, second, third, etc. may be used herein to describe various elements or components, these elements or components should not be limited by these terms. These terms are only used to distinguish one element or component from another element or component. Thus, a first element or component discussed below could be termed a second element or component without departing from the teachings of the inventive concept.
The terminology used herein is for purposes of describing particular embodiments only and is not intended to be limiting. As used in the specification and appended claims, the singular forms of terms “a,” “an” and “the” are intended to include both singular and plural forms, unless the context clearly dictates otherwise. Additionally, the terms “comprises,” “comprising,” and/or similar terms specify the presence of stated features, elements, and/or components, but do not preclude the presence or addition of one or more other features, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items.
Unless otherwise noted, when an element or component is said to be “connected to,” “coupled to,” or “adjacent to” another element or component, it will be understood that the element or component can be directly connected or coupled to the other element or component, or intervening elements or components may be present. That is, these and similar terms encompass cases where one or more intermediate elements or components may be employed to connect two elements or components. However, when an element or component is said to be “directly connected” to another element or component, this encompasses only cases where the two elements or components are connected to each other without any intermediate or intervening elements or components.
The present disclosure, through one or more of its various aspects, representative embodiments and/or specific features or sub-components, is intended to bring out one or more of the advantages as specifically noted below. For purposes of explanation and not limitation, representative embodiments disclosing specific details are set forth in order to provide a thorough understanding of an embodiment according to the present teachings. However, other embodiments consistent with the present disclosure that depart from specific details disclosed herein remain within the scope of the appended claims. Moreover, descriptions of well-known apparatuses and methods may be omitted so as to not obscure the description of the example embodiments. Such methods and apparatuses are within the scope of the present disclosure.
Generally, and as described below in connection with various representative embodiments, the present teachings are directed to including a shape-memory alloy (SMA) element, or a bi-metal element in the medical connector of the consumable (sometimes referred to herein as a medical connector). These consumables may be, for example, but are certainly not limited to, electrocardiograph (ECG) lead sets, SpO2 sensors, temperature probes, as well as other devices that must be sterilized, or disinfected, or both, before being reconnected to a mating connector of a medical component/instrument. Notably, and as described more fully below, disinfection and sterilization are carried out at different temperatures. The most common sterilization method is steam sterilization (e.g., using an autoclave) that occurs at higher temperatures than in an automated washer. The SMA transformation temperature is, therefore, not set above the sterilization temperature. Notably, in certain representative embodiments only the disinfection step is required/mandatory and the sterilization step optional.
When detached from a mating connector (e.g., a connector of a patient monitor), the SMA element is deformed to a blocked state. The deformed shape of the SMA element in the blocked state prevents the medical connector from being reconnected to its mating connector (not shown). In its blocked state, the medical connector is heated to at least its transformation temperature, and the SMA element is reformed to its original shape so it can again be reconnected to its mating connector. In this state, the medical connector is unblocked. By the present teachings, the transformation temperature of the SMA is chosen such that when the consumable is subjected to the high temperatures of disinfecting and/or sterilization methods, such as automated cleaning or steam sterilization, it returns to its pre-deformed shape. In that situation, the medical connector can be reinserted in its corresponding mating connector (e.g. reconnected to a patient monitor).
As described in connection with various representative embodiments below, the present teachings include providing consumables (e.g. ECG lead sets, SpO2 sensors, temperature probes, etc.) that can be cleaned, disinfected, and sterilized at clinical locations (e.g., hospitals or medical clinics), or alternatively at a third-party location. For example, since many hospitals and clinics have a Central Sterilization Facility (CSF) where medical devices are disinfected in an automated washer and sterilized in an autoclave. Such automated washer and sterilization steps may be defined by the following standards: ISO 15883 for the automated cleaning; and ISO 17665 for the autoclave step. In accordance with various representative embodiments, the transformation temperature of the SMA element of the medical connector is selected to be greater than the maximum expected ambient room temperature (typically in the range of 25° C.-30° C.), and no greater than the temperature required by ISO 15883, if only automated cleaning and disinfection is required; or no greater than the temperature required by ISO 17665 if steam sterilization in an autoclave is required or mandatory. As such, the temperature of the automated washer and/or autoclave needs to be larger than the SMA transformation temperature.
As will become clearer as the present description continues, a medical connector that is adapted to connect to a mating connector is blocked (or in a blocked state) when a component of the medical connector of the medical device is deformed so the medical connector cannot engage the mating connector. By contrast, a medical connector that is adapted to connect to a mating connector is unblocked (or in an unblocked state) when a component of the medical connector of the medical device is reformed so the medical connector can engage the mating connector. Various aspects of the method are described below in connection with various representative embodiments.
At 101, the state of the medical connector is assessed to determine whether or not the medical connector (sometimes referred to herein as a consumable) is blocked. If the medical connector is blocked, the method 100 proceeds to 102 to determine if the medical connector should be reprocessed. Specifically, when the consumable is blocked, and thus does not fit in the mating connector (e.g., monitor) at 101, the medical staff can either decide to reprocess the consumable at 103; or not to reprocess it. The method 100 then returns to 101.
At 103, the method continues with the cleaning, disinfecting, and if desired or required, sterilization of the medical connector. As noted above, the medical connector is disinfected in an automated washer and sterilized in most cases in an autoclave. These two steps are defined by the following standards: ISO 15883 for the automated cleaning; and ISO 17665 for the autoclave step. In accordance with various representative embodiments, the transformation temperature of the SMA element of the medical connector is selected to be greater than the maximum expected ambient room temperature (typically in the range of 25° C.-30° C.), and no greater than the temperature required by ISO 15883, if only automated cleaning and disinfection is required; or no greater than the temperature required by ISO 17665 if steam sterilization in an autoclave is required.
Since the temperature of the washer and/or autoclave steps as required by ISO 15883 and ISO17665, respectively, are greater than the transformation temperature of the SMA in 103, the SMA is reformed to its original shape, and the method continues to 104 with the medical connector's returning to its unblocked state.
Once the medical connector is unblocked, the medical connector is clean, disinfected and if desired or required, sterilized, and can be used again by a clinician. As such, the method 100 continues to 105 where the medical connector is used to engage a mating connector.
At 106, after use, the medical connector is disconnected from its mating connector (e.g., at a monitor of a medical instrument). As alluded to above, and as described more fully below, disconnecting the medical connector deforms the SMA element, and at 107, the method 100 continues with the medical connector's being blocked again. Again, in the blocked state, the medical connector cannot be reconnected to its mating connector unless and until the SMA element is reformed to its original shape—where the transformation temperature required to reform the SMA element of the medical connector is selected to be no greater than the temperature required by ISO 15883, or ISO 17665 if sterilization in an autoclave is required. With the medical connector's being heated to at least these temperatures, the medical device is properly cleaned, disinfected and, if desired or required, sterilized. The medical connector is again in the unblocked state, and can be safely connected to it mating connector of the medical instrument.
As shown in
As shown in
Because of the depression of the button 202, the SMA element 201 is deformed with the portion near the extremity 205 and extending in a curved manner as shown. When the SMA element 201 is deformed, connection of the medical connector 200 to its mating connector (not shown) cannot be done. As such, the shape of the mating end of the medical connector 200 prevents the medical connector from mating with the mating connector (not shown) of the medical instrument or other mating connector (not shown). Accordingly, since the SMA element 201 is deformed, the medical connector 200 is in a blocked state, and cannot be reconnected to the medical instrument or other mating connector without having been cleaned disinfected, and, if desired or required, sterilized by at least the standards noted above.
As shown in
By the present teachings, the shape memory alloy used for the SMA element 201 is selected to ensure return to its original state (i.e., its shape in
Accordingly, in connection with representative embodiments of
As shown in
The lead set 400 includes a plurality of pins 401, and each of the plurality of pins 401 comprises an electrically shielding electrode 403. As described more fully below, in a representative embodiment, the electrically shielding electrodes 403 comprise a shape memory alloy that is in its original state (i.e., not deformed) in
As shown in
As shown in
As shown in
By the present teachings, the shape memory alloy used for the electrically shielding electrode 403 is selected to ensure return to its original state (i.e., its shape in
Accordingly, in connection with representative embodiments of
In the previously described representative embodiments, an external force is applied by the user to deform the SMA element when the consumable is removed from its socket. The presently described representative embodiments describe an implementation where the consumable is automatically blocked when removed from its socket. Although the implementation of this embodiment requires additional elements (compared to the previous embodiments), no external force applied by the user is needed.
When the medical connector 500 is inserted in its corresponding mating connector, a second spring loaded pin 502 is pushed back in the medical connector 500, as shown in
Once disconnected from a patient monitor or similar device, the second spring loaded pin 502 is again moved to the left, as depicted in
Turning to
Although various medical connectors and lead sets have been described with reference to several representative embodiments, it is understood that the words that have been used are words of description and illustration, rather than words of limitation. Changes may be made within the purview of the appended claims, as presently stated and as amended, without departing from the scope and spirit of interventional procedure optimization in its aspects. Although developing adaptable predictive analytics has been described with reference to particular means, materials and embodiments, developing adaptable predictive analytics is not intended to be limited to the particulars disclosed; rather developing adaptable predictive analytics extends to all functionally equivalent structures, methods, and uses such as are within the scope of the appended claims.
The illustrations of the representative embodiments described herein are intended to provide a general understanding of the structure of the various embodiments. The illustrations are not intended to serve as a complete description of all of the elements and features of the disclosure described herein. Many other embodiments may be apparent to those of skill in the art upon reviewing the disclosure. Other embodiments may be utilized and derived from the disclosure, such that structural and logical substitutions and changes may be made without departing from the scope of the disclosure. Additionally, the illustrations are merely representational and may not be drawn to scale. Certain proportions within the illustrations may be exaggerated, while other proportions may be minimized. Accordingly, the disclosure and the figures are to be regarded as illustrative rather than restrictive.
Although specific embodiments have been illustrated and described herein, it should be appreciated that any subsequent arrangement designed to achieve the same or similar purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all subsequent adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the description.
The Abstract of the Disclosure is provided to comply with 37 C.F.R. § 1.72(b) and is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In addition, in the foregoing Detailed Description, various features may be grouped together or described in a single embodiment for the purpose of streamlining the disclosure. This disclosure is not to be interpreted as reflecting an intention that the claimed embodiments require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter may be directed to less than all of the features of any of the disclosed embodiments. Thus, the following claims are incorporated into the Detailed Description, with each claim standing on its own as defining separately claimed subject matter.
The preceding description of the disclosed embodiments is provided to enable any person skilled in the art to practice the concepts described in the present disclosure. As such, the above disclosed subject matter is to be considered illustrative, and not restrictive, and the appended claims are intended to cover all such modifications, enhancements, and other embodiments which fall within the true spirit and scope of the present disclosure. Thus, to the maximum extent allowed by law, the scope of the present disclosure is to be determined by the broadest permissible interpretation of the following claims and their equivalents and shall not be restricted or limited by the foregoing detailed description.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2021/076010 | 9/22/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63086124 | Oct 2020 | US |
