Multi-use medical device with shape memory alloy for blocking use prior to disinfection / sterilization

Abstract

A method for ensuring that a medical connector of a medical device is disinfected or sterilized is disclosed. The method includes receiving the medical connector in a blocked state, where a component of the medical connector comprises a shape memory alloy (SMA), and heating the medical connector to a temperature sufficient to change the shape of the SMA to an unblocked state. A medical connector comprising SMA material is also disclosed.

Description

[Technical Field]

[0001] For example, medical consumables such as electrocardiogram (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 described in the title, multi-patient use consumables are used on many different patients over the life of the consumable. These consumables are cleaned and / or sterilized after each use. [Background technology]

[0002] Typically, disinfectant wipes are used by hospital staff to clean these consumables. However, this method has several drawbacks. For example, cleaning consumables is time-consuming and adds an additional task to medical personnel's daily duties. Furthermore, many consumables are difficult to clean. For example, small protrusions and clamps on some ECG leads make them difficult to thoroughly clean and disinfect. For example, bacteria have been found to be common on reusable, cleaned leads. Therefore, these consumables are considered a potential source of hospital-acquired infections (HAIs).

[0003] As an alternative, hospitals can choose single-patient use consumables. With this type of consumable, patients always receive clean equipment, limiting the risk of hospital-acquired infections (HAIs). Such consumables are considered convenient because they are always ready for use and do not require hand washing after each use. Compared to multi-patient use consumables, the overall cost of using consumable equipment is greater. Furthermore, single-patient consumables result in an unacceptable increase in electronic and biohazard waste. In addition, healthcare facilities that rely on single-patient use consumables must regularly replenish supplies of these components, and healthcare facilities experience shortages of these components and delivery delays by suppliers, to name a few drawbacks. Summary of the Invention [Problem to be solved by the invention]

[0004] Therefore, there is a need for a medical component that overcomes at least the shortcomings of known components discussed above. [Means for solving the problem]

[0005] According to one aspect of the present disclosure, a method for ensuring that a medical connector of a medical device is disinfected and / or sterilized is disclosed, the method comprising 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 temperature sufficient to change the shape of the SMA to an unblocked state.

[0006] According to another aspect of the present disclosure, a medical device is disclosed having a medical connector having a shape memory alloy (SMA) adapted to engage with a mating connector in an unblocked state, wherein disengaging from the medical connector causes the SMA to become blocked. [Brief explanation of the drawings]

[0007] Representative embodiments will be better understood from the following detailed description when read in conjunction with the accompanying drawings. It is emphasized that the various features are not necessarily drawn to scale. In fact, dimensions may be arbitrarily increased or decreased for clarity. Wherever applicable and practical, like reference numerals refer to like elements. [Figure 1] FIG. 1 is a flowchart of a method for preventing a medical device from being connected to an instrument before it has been unblocked by disinfection and / or sterilization, according to a representative embodiment. [Figure 2]FIG. 2 is a simplified cross-sectional view of a medical connector having a shape memory alloy (SMA) illustrating the state of the shape memory alloy in three stages of use according to a representative embodiment. [Figure 3] FIG. 3 is a simplified side view of the connector of the medical device of FIG. 2A in an unblocked state according to a representative embodiment. [Figure 4A] FIG. 4A is a perspective view of an electrocardiograph (ECG) lead set having an electrical shielding electrode according to a representative embodiment. [Figure 4B] 4B is a simplified cross-sectional view of the ECG lead set shown in FIG. 4A illustrating the state of the SMA at three stages of use of the ECG lead set according to a representative embodiment. [Figure 4C] 4C is a simplified cross-sectional view of the ECG lead set shown in FIG. 4A illustrating the state of the SMA at three stages of use of the ECG lead set according to a representative embodiment. [Figure 4D] 4D is a simplified cross-sectional view of the ECG lead set shown in FIG. 4A illustrating the state of the SMA at three stages of use of the ECG lead set according to a representative embodiment. [Figure 5A] 5A-5C are simplified cross-sectional views of an electrical connector of a medical device showing the state of an SMA at various stages of use of the electrical connector according to a representative embodiment. [Figure 5B] 5A and 5B are simplified cross-sectional views of an electrical connector of a medical device showing the state of an SMA at various stages of use of the electrical connector according to a representative embodiment. [Figure 5C] 5A-5C are simplified cross-sectional views of an electrical connector of a medical device showing the state of an SMA at various stages of use of the electrical connector according to a representative embodiment. [Figure 5D] 5A-5D are simplified cross-sectional views of an electrical connector of a medical device showing the state of an SMA at various stages of use of the electrical connector according to a representative embodiment. [Figure 5E] 5E are simplified cross-sectional views of an electrical connector of a medical device showing the state of an SMA at various stages of use of the electrical connector according to a representative embodiment. [Figure 5F] 5F are simplified cross-sectional views of an electrical connector of a medical device showing the state of an SMA at various stages of use of the electrical connector according to a representative embodiment. [Figure 5G] 5G are simplified cross-sectional views of an electrical connector of a medical device showing the state of an SMA at various stages of use of the electrical connector according to a representative embodiment. [Figure 5H] 5H are simplified cross-sectional views of an electrical connector of a medical device showing the state of an SMA at various stages of use of the electrical connector according to a representative embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0008] In the following detailed description, for purposes of explanation and not limitation, exemplary embodiments disclosing specific details are described to provide a thorough understanding of embodiments according to the present teachings. Descriptions of known systems, devices, materials, methods of operation, and manufacturing processes may be omitted so as to avoid obscuring the description of the exemplary embodiments. Nevertheless, systems, devices, materials, and methods within the purview of those skilled in the art are within the scope of the present teachings and may be used in accordance with the exemplary embodiments. It is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. Defined terms are given the technical and scientific meaning of the defined terms as commonly understood and accepted in the art of the present teachings.

[0009] Although terms such as "first," "second," and "third" are used in the specification to describe various elements or components, it should be understood that these elements or components should not be limited by these terms. These terms are used only to distinguish one element or component from another. 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.

[0010] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used in this specification and the appended claims, a plurality of terms includes a plurality unless the context clearly dictates otherwise. Additionally, the terms "comprises," "having," and / or the like specify the presence of stated features, elements, and / or components, but do not exclude 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.

[0011] Unless otherwise stated, when an element or component is "connected," "coupled," or "adjacent" to another element or component, it is understood that the element or component is directly connected or coupled to the other element or component, or that intervening elements or components may be present. That is, these and similar terms encompass the case where one or more intermediate elements or components are used to connect the two elements or components. However, when an element or component is described as "directly connected" to another element or component, this only encompasses the case where the two elements or components are connected to each other without any intermediate or intervening components.

[0012] The present disclosure is intended to provide one or more of the advantages, as specifically set forth below, through one or more of its various aspects, exemplary embodiments, and / or specific features or subcomponents. For purposes of explanation and not limitation, exemplary embodiments disclosing specific details are described to provide a thorough understanding of embodiments according to the present teachings. However, other embodiments consistent with the present disclosure that depart from the specific details disclosed herein are within the scope of the appended claims. Moreover, descriptions of known devices and methods may be omitted so as not to obscure the description of the exemplary embodiments. Such methods and devices are within the scope of the present disclosure.

[0013] Generally, and as described below in connection with various exemplary embodiments, the present teachings are directed to including shape memory alloy (SMA) or bimetal elements in consumable medical connectors (sometimes referred to herein as medical connectors). These consumables include, but are not limited to, electrocardiogram (ECG) lead sets, SpO2 sensors, temperature sensors, and other devices that must be sterilized and / or disinfected before being reconnected to a mating connector on a medical component / instrument. In particular, and as described more fully below, disinfection and sterilization are performed at different temperatures. The most common sterilization method is steam sterilization (e.g., using an autoclave), which is performed at a temperature higher than that of an automatic washer. Thus, the transformation temperature of the SMA is not set above the sterilization temperature. Notably, in certain exemplary embodiments, only the disinfection step is necessary / mandatory, and the sterilization step is optional.

[0014] When removed from a mating connector (e.g., a connector on a patient monitor), the SMA element deforms to a blocked state. This blocked, deformed shape of the SMA element prevents the medical connector from being reconnected to the mating connector (not shown). In the blocked state, the medical connector can be heated to at least its transformation temperature, reforming the SMA element to its original shape so that it can again be reconnected to the mating connector. In this state, the medical connector is unblocked. In accordance with the present teachings, the transformation temperature of the SMA is selected so that when the consumable is exposed to the elevated temperatures of a disinfection and / or sterilization method, such as an automatic cleaning or steam sterilization, the consumable returns to its previous, deformed shape. In that state, the medical connector can be reinserted into a corresponding mating connector (e.g., reconnected to a patient monitor).

[0015] As described in connection with various exemplary embodiments below, the present teachings include providing consumables (e.g., electrocardiogram lead sets, SpO2 sensors, thermometers, etc.) that can be cleaned, disinfected, and sterilized at a clinical location (e.g., a hospital or clinic) or, alternatively, at a third-party location. For example, many hospitals and clinics have central sterilization facilities (CSFs) where medical devices are disinfected in automatic washers and sterilized in autoclaves. Such automatic cleaning and sterilization steps are governed by the following standards: ISO 15883 for automatic cleaning steps and ISO 17665 for autoclave steps. According to various exemplary embodiments, the transformation temperature of the SMA elements of the medical connector is selected to be higher than the highest expected ambient room temperature (typically in the range of 25°C to 30°C) and not to exceed the temperature required by ISO 15883 if only automatic cleaning and disinfection is required, or not to exceed the temperature required by ISO 17665 if steam sterilization in an autoclave is necessary or required. Therefore, the temperature of the automatic cleaning and autoclave must be higher than the transformation temperature of the SMA.

[0016] FIG. 1 is a flowchart of a method 100 for preventing a medical connector from being connected to a device before it has been unblocked by disinfection and / or sterilization, according to a representative embodiment.

[0017] As will become clearer as this description proceeds, when a component of a medical connector of a medical device is deformed, the medical connector adapted to connect to a mating connector is blocked (or becomes blocked) so that the medical connector cannot engage with the mating connector. In contrast, when a component of a medical connector of a medical device is reshaped, the medical connector adapted to connect to a mating connector is unblocked (or becomes unblocked) so that the medical connector can engage with the mating connector. Various aspects of the method are described below in connection with various representative embodiments.

[0018] At 101, the condition of the medical connector (sometimes referred to herein as the consumable) is evaluated to determine whether the medical connector is blocked. If the medical connector is blocked, method 100 proceeds to 102 to determine whether the medical connector should be reprocessed. Specifically, when the consumable is blocked and therefore does not mate with a mating connector (e.g., a monitor) at 101, medical staff can decide either to reprocess the consumable or not at 103. Method 100 then returns to 101.

[0019] At 103, the method continues with cleaning, disinfecting, and, if desired or necessary, sterilizing the medical connector. As noted above, medical connectors are disinfected in automatic washers and, in most cases, sterilized in autoclaves. These two steps are defined by the following standards: ISO 15883 for the automatic washer step and ISO 17665 for the autoclave step. According to various exemplary embodiments, the transformation temperature of the SMA element of the medical connector is selected to be higher than the highest expected ambient room temperature (typically in the range of 25°C to 30°C) and not to exceed the temperature required by ISO 15883 if only automatic cleaning and disinfection are required, or ISO 17665 if steam sterilization in an autoclave is required.

[0020] As required by ISO 15883 and ISO 17665, respectively, at 103, the temperature of the washing and / or autoclaving step is above the transformation temperature of the SMA, so the SMA reforms to its original shape and the method proceeds to 104, where the medical connector returns to an unblocked state.

[0021] Once the medical connector is unblocked, it can be cleaned, disinfected, and sterilized as desired or necessary, and reused by the clinician. Thus, method 100 continues at 105, where the medical connector is used to mate with a mating connector.

[0022] At 106, after use, the medical connector is disconnected from the mating connector (e.g., on a medical device monitor). As suggested above and explained more fully below, disconnecting the medical connector deforms the SMA element, and at 107, method 100 continues with the medical connector in a blocked state. Again, in the blocked state, the medical connector cannot be reconnected to the mating connector unless and until the SMA element reforms to its original shape, where the transformation temperature required to reform the SMA element of the medical connector is selected not to exceed the temperatures required by ISO 15883 or, if sterilization in an autoclave is required, ISO 17665. When the medical connector is heated to at least these temperatures, the medical device can be properly cleaned, disinfected, or sterilized as desired or necessary. The medical connector is again unblocked and can be safely connected to the mating connector of the medical device.

[0023] 2A-2C are simplified cross-sectional views of a medical connector 200 having an SMA element showing the state of the SMA element at three stages (A, B, C) of use according to a representative embodiment. Various aspects and details of medical connector 200 are common to those described in the above sections of the detailed description. These aspects and details are not necessarily repeated, but are nonetheless germane to the presently described representative embodiment.

[0024] As shown in FIG. 2A, medical connector 200 includes SMA element 201, button 202, and pin 203. As will become clearer as this description proceeds, medical connector 200 is in an unblocked state and can be connected to, for example, a mating connector (not shown) of a medical device. In this unblocked state, SMA element 201 is intact and therefore does not block connection with the mating connector. As described above and below, medical connector 200 of FIG. 2A can be cleaned, disinfected, and sterilized as desired or necessary.

[0025] As shown in FIG. 2B, button 202 is illustratively depressed by finger / thumb 204. However, notably, button 202 may be depressed using a tool or other similar device rather than finger / thumb 204. As shown, SMA element 201 is fixed at distal end 205 of medical connector 200 and at approximately mid-portion 206 of SMA element 201. Stated somewhat differently, at distal end 205 and approximately mid-portion 206, SMA element 201 is in direct contact with a non-movable element (302 in FIG. 3) of medical connector 200. Thus, SMA element 201 is fixed at these points.

[0026] Depressing button 202 causes SMA element 201 to deform near tip 205, extending in a curved fashion as shown. When SMA element 201 deforms, medical connector 200 cannot connect to a mating connector (not shown). Thus, the shape of the mating end of medical connector 200 prevents the medical connector from mating with a medical device mating connector (not shown) or other mating connector (not shown). Thus, with SMA element 201 deformed, medical connector 200 is blocked and cannot be reconnected to a medical device or other mating connector unless it is cleaned, disinfected, and, if desired or necessary, sterilized according to at least the standards described above.

[0027] As shown in FIG. 2C, button 202 is released. However, because SMA element 201 has deformed, it remains in its deformed shape and cannot be connected to a mating connector until it is heated to return to its original state. According to an exemplary embodiment, SMA element 201 may be one of a variety of shape memory alloys within the purview of those skilled in the art. By way of example only and not limitation, the shape memory alloy used in SMA element 201 may be one or more of Ag—Cd, Au—Cd, Cu—Al—Ni, Cu—Sn, Cu—Zn—(X), In—Ti, Ni—Al, Ni—Ti, Fe—Pt, Mn—Cu, and Fe—Mn—Si alloys. These alloys are a group of metallic materials that have the property of returning to a previously defined shape when subjected to an appropriate heat treatment. The shape memory effect results from a temperature- and stress-dependent shift in the crystalline structure of a material between two distinct phases: martensite (a low-temperature phase) and austenite (a high-temperature phase). The temperature at which the phase transformation occurs is called the transformation temperature, as mentioned above.

[0028] In accordance with the present teachings, the shape memory alloy used in SMA element 201 is selected to ensure that it returns to its original state (i.e., the shape in FIG. 2A) only after being heated to a temperature sufficient to ensure cleaning, disinfection, and, if desired, sterilization of the components of the medical connector. Thus, medical connector 200 in FIG. 2C is subjected to a heating step at a temperature sufficient to disinfect, and, if desired, sterilize the components of medical connector 200 that engage with a medical device or mating connector (not shown). After being heated sufficiently in the disinfection and sterilization process, if desired, or sterilization, SMA element 201 returns to its original shape, as shown in FIG. 2A. In this unblocked state, SMA element 201 does not prevent medical connector 200 from connecting to a medical device or mating connector (not shown) and can be reconnected to the mating connector in a cleaned, disinfected, and, if desired, sterilized state for further use.

[0029] 2A-2C, the medical connector 200 completes a cycle of removing and deforming the SMA element 201, heating to clean, disinfect, and sterilize the components of the medical connector as desired or necessary, and reforming the SMA element 201 to its original state for further use by connecting to a mating connector or medical device (not shown). Thus, in its original state (FIG. 2A), the SMA element 201 is in Shape 1 (unblocked shape). Thus, the medical connector 200 can be inserted into a corresponding mating connector (e.g., a connector of a medical device such as a patient monitor). The SMA element is secured in two positions, namely, at the distal end 205 of the medical connector 200 and at approximately the midpoint 206 of the SMA element 201, as shown in FIG. 2B. A button 202 is also added to the medical connector. Button 202 is positioned so that a user manually presses the button (or uses a tool to press it) when removing medical connector 200 from a medical device or mating connector. A locking mechanism can potentially be added that is unlocked by the button so that the consumable cannot be removed unless the patient presses the button. When button 202 is pressed, an external force is applied to SMA element 201. This action causes SMA element 201 to transform into Shape 2 (blocked shape). As shown in FIG. 2C, the shape of the SMA element is such that medical connector 200 cannot be reinserted into a corresponding mating connector or medical device (not shown). Upon disinfection, and sterilization (e.g., in CSF) if desired or necessary, SMA element 201 reaches a transformation temperature M S Thus, the SMA element 201 returns to its original shape, i.e., Shape 1 (unblocked, A in FIG. 2), allowing the medical connector to be reinserted into a corresponding mating connector or medical device in a disinfected or sterilized state as desired or needed.

[0030] 3 is a simplified side view of the medical connector 200 of FIG. 2A in an unblocked state, according to a representative embodiment. Various aspects and details of the medical connector 200 are common to those described in the above portions of the detailed description. These aspects and details are not necessarily repeated, but are nonetheless germane to the currently described representative embodiment.

[0031] As shown in FIG. 3 , medical connector 200 has a relatively circular cross-section. Medical connector 200 has an outer portion 301 comprised of SMA element 201 and non-movable element 302. In this unblocked state, the shape of medical connector outer portion 301 is selected to mate with a corresponding outer portion of a mating connector (not shown) and to ensure that pins 203 easily mate with corresponding receiving portions of the mating connector or medical device. In contrast, deformation of SMA element 201 (e.g., by pressing button 202 shown in FIG. 2B) results in deformation of medical connector 200 outer portion 301 (see FIG. 2B) such that outer portion 301 cannot mate with the outer portion of the mating connector or medical device (not shown), thereby preventing medical connector 200 from mating with the mating connector or medical device in the blocked state. Again, to allow medical connector 200 to mate with a mating connector, a step is performed in which medical connector 200 is heated to a temperature sufficient to disinfect and, if desired or necessary, sterilize the components of medical connector 200 that engage with the medical instrument or device. After sufficient heating in the disinfection and, if desired or necessary, sterilization process, SMA element 201 returns to its original shape, as shown in Figures 2A and 3. In this unblocked state, SMA element 201 does not interfere with the connection of medical connector 200, and the medical connector can be re-mated with the outer portion of a mating connector (not shown) in a disinfected, or, if desired or necessary, sterilized state for further use.

[0032] 4A is a perspective view of an electrocardiograph (ECG) lead set 400 (i.e., medical connector) with electrically shielded electrodes according to a representative embodiment. Various aspects and details of lead set 400 are common to those described in the preceding sections of the detailed description. These aspects and details are not necessarily repeated, but are nonetheless germane to the presently described representative embodiment.

[0033] The lead set 400 includes a plurality of pins 401, each of which includes an electrical shielding electrode 403. As described more fully below, in an exemplary embodiment, the electrical shielding electrode 403 comprises a shape memory alloy that is in the original (i.e., undeformed) state of FIG. 4. When the electrical shielding electrode 403 is in its original state, the lead set 400 is unblocked and can be connected to a mating connector or medical device (not shown). As described more fully in connection with FIGS. 4B-4D, deformation of the lead set 400 while detaching it from a mating connector or medical device (not shown) blocks the lead set 400, thereby preventing connection of the lead set 400 to a mating connector of an ECG device until cleaning, disinfection, and, if desired or necessary, sterilization have been completed. Thus, and as described above and below, exposure to heat in the order of cleaning, disinfection, and, if desired or necessary, sterilization restores the SMA material electrical shielding electrode 403 to its original shape as shown in FIG. 4A (as more clearly shown in FIG. 4B).

[0034] 4B-4D are simplified cross-sectional views of ECG lead set 400 shown in FIG. 4A illustrating the state of the SMA at three stages of use of an ECG lead set according to a representative embodiment. Various aspects and details of lead set 400 are common to those described in the above sections of the detailed description. These aspects and details are not necessarily repeated, but are nonetheless germane to the currently described representative embodiment.

[0035] As shown in FIG. 4B , lead set 400 includes an electrical shielding electrode 403, a button 402, and a pin 401. In particular, electrical shielding electrode 403 is made from a shape memory alloy (SMA) as described above. As will become clearer as this description proceeds, in FIG. 4B , lead set 400 is in an unblocked state and can be connected to a mating connector or medical device. In this unblocked state, electrical shielding electrode 403 is in its original state and therefore not blocked from connection with a mating connector. As described above and below, lead set 400 of FIG. 4B can be cleaned, disinfected, and sterilized as desired or necessary.

[0036] As shown in FIG. 4C , the button 402 is illustratively depressed with a finger / thumb 404. However, notably, the button 402 may be depressed using a tool or other similar device rather than by hand. As shown, the electrical shielding electrode 403 is fixed at the distal end 405 of the lead set 400 and at a location approximately midway 406 of the electrical shielding electrode 403. Again, and as discussed above in the description of the exemplary embodiment of FIGS. 2A-3 , at the distal end 405 of the lead set 400, the electrical shielding electrode 403, which comprises SMA material, is in direct contact with the non-moving portion of the lead set 400. Thus, the electrical shielding electrode 403 is fixed at these points. Depressing the button 402 causes the electrical shielding electrode 403 near the distal end 405 to deform, extending in a curved manner as shown. When the electrical shielding electrode 403 is deformed, the lead set 400 cannot be connected to a mating connector (not shown). Thus, the shape of the mating end of lead set 400 prevents the lead set from mating with a mating connector or medical device (not shown). Thus, due to deformation of the SMA element of electrical shielding electrode 403, lead set 400 is blocked and cannot be reconnected to a mating connector or medical device (not shown) without being cleaned, disinfected, and, if desired or necessary, sterilized per at least the standards described above.

[0037] As shown in FIG. 4D , the button 402 is released. However, because the electrical shielding electrode 403 has been deformed, it remains in its deformed shape and cannot be connected to a mating connector until it is heated to return to its original state. According to an exemplary embodiment, the electrical shielding electrode 403 can be made from one of a variety of shape memory alloys within the purview of those skilled in the art. By way of example only and not limitation, the shape memory alloy used in the electrical shielding electrode 403 may be one or more of Ag—Cd, Au—Cd, Cu—Al—Ni, Cu—Sn, Cu—Zn—(X), In—Ti, Ni—Al, Ni—Ti, Fe—Pt, Mn—Cu, and Fe—Mn—Si alloys. These alloys are a group of metallic materials that have the property of returning to a previously defined shape when subjected to an appropriate heat treatment. The shape memory effect occurs due to a temperature- and stress-dependent shift in the crystalline structure of a material between two distinct phases: martensite (a low-temperature phase) and austenite (a high-temperature phase). The temperature at which the phase transformation occurs is called the transformation temperature, as mentioned above.

[0038] In accordance with the present teachings, the shape memory alloy used in the electrical shielding electrode 403 is selected to ensure that it returns to its original state (i.e., the shape in FIG. 2A) only after being heated to a temperature sufficient to ensure cleaning, disinfection, and, if desired, sterilization of the components of the medical connector. Thus, the lead set 400 of FIG. 4D is subjected to a heating step at a temperature sufficient to disinfect, and, if desired, sterilize the components of the lead set 400 that engage with a medical instrument or device. After being heated sufficiently in the disinfection and sterilization process, if desired, sterilization occurs, the electrical shielding electrode 403, comprising SMA material, returns to its original shape, as shown in FIG. 5A. In this unblocked state, the electrical shielding electrode 403 does not prevent connection to the lead set 400's mating connector or medical instrument (not shown) and can be reconnected to the mating connector or medical instrument in a disinfected or, if desired, sterilized state for further use.

[0039] 4B-4D, the lead set 400 completes a cycle of removing and deforming the electrical shielding electrode 403, cleaning, disinfecting, and heating the components of the medical connector to sterilize them as desired or necessary, and then reshaping the electrical shielding electrode 403 to its original state for further use by connecting it to a mating connector (not shown) of a medical device. Thus, in its original state (FIG. 4B), the electrical shielding electrode 403, including the SMA material, is in Shape 1 (unblocked). Thus, the lead set 400 can be inserted into a corresponding mating connector (e.g., a connector of a medical device such as a patient monitor). The electrical shielding electrode 403 with the SMA element is secured in two positions, namely, at the distal end 405 of the lead set 400 and at approximately the midpoint 406 of the electrical shielding electrode 403, as shown in FIG. 4C. A button 402 is also added to the medical connector. The button 402 is positioned so that a user manually presses the button (or uses a tool to press it) when removing the lead set 400 from a mating connector (not shown). A locking mechanism can potentially be added that is unlocked by the button 402 so that consumables cannot be removed unless the button 402 is pressed. When the button 402 is pressed, an external force is applied to the first spring-loaded pin. This action causes the SMA material electrical shielding electrode 403 to deform into Shape 2 (blocked shape). As shown in FIG. 4D , the shape of the SMA material electrical shielding electrode 403 is such that the lead set 400 cannot be reinserted into a corresponding mating connector of a medical device. After disinfection and, if desired or necessary, sterilization (e.g., in CSF), the SMA material electrical shielding electrode 403 will reach a transformation temperature M S Thus, the shape of the electrically shielded electrode 403 with SMA material returns to its original form, i.e., Shape 1 (unblocked, FIG. 4B), allowing the medical connector to be reinserted into a corresponding mating connector or medical device (not shown) under disinfected or sterilized conditions.

[0040] 5A-5H are simplified cross-sectional views of a medical connector 500 for a medical device, illustrating the state of an SMA at various stages of use of the medical connector according to a representative embodiment. Various aspects and details of the medical connector 500 are common to those described in the above sections of the detailed description. These aspects and details are not necessarily repeated, but are nonetheless germane to the presently described representative embodiment.

[0041] In the exemplary embodiment described above, when removing the consumable from the socket, an external force is applied by the user, causing the SMA element to deform. The exemplary embodiment described here describes an implementation in which the consumable is automatically blocked when the consumable is removed from the socket. Implementation of this embodiment requires additional elements (compared to the previous embodiment), but does not require an external force applied by the user.

[0042] Figure 5A shows a first spring-loaded pin 501, which may be an actual electrical pin or an additional pin that has no function other than to prevent the consumable from being inserted into a corresponding mating connector (not shown) when not being reprocessed. Notably, the medical connector 500 of Figure 5A is at ambient temperature.

[0043] When medical connector 500 is inserted into a corresponding mating connector, as shown in Figure 5B, second spring-loaded pin 502 is pushed back into medical connector 500. Again, medical connector 500 in Figure 5B is at ambient temperature. First spring-loaded pin 501 is also pushed back by the same action.

[0044] Upon removal from the patient monitor or similar device, the second spring-loaded pin 502 moves to the left again, as shown in FIG. 5C. The first spring-loaded pin 501 is then depressed by the SMA or bimetallic material element 503, which is designed to depress the first spring-loaded pin 501 at ambient temperature. Thus, the first spring-loaded pin 501 is also depressed to its previous state described in FIGS. 5A-5B. As shown in FIG. 5D, the first spring-loaded pin 501 is depressed by the SMA or bimetallic material element 503, as shown in FIG. 5D. Thus, the first spring-loaded pin 501 prevents the electrical connector 600 from being properly inserted into a corresponding mating connector, making it impossible to use a second time.

[0045] Returning to FIG. 5E, the medical connector 500 may be disinfected in an automatic washer or sterilized in an autoclave, if desired or necessary, and thus exposed to high temperatures as described in the sections above. In this case, the SMA or bimetallic material element 503 bends under spring load, as shown in FIG. 5E, pushing back the first spring-loaded pin 501. At the same time, as illustrated in FIGS. 5F and 5G, an additional spring-loaded push mechanism 506 pushes the first spring-loaded pin 501 to the left. The springs in this spring-loaded push mechanism 506 include a first spring 607 and a second spring 609, as shown in FIGS. 5F-5G, which comprise a bimetallic or SMA material that bends at high temperatures. When the medical connector returns to ambient temperature, the push mechanism 505 returns to its original state (identical to the state described in connection with FIG. 5A), as shown in FIG. 5H, and the cycle begins again.

[0046] Although various medical connectors and lead sets have been described with reference to several representative embodiments, it is understood that the terms used are terms of description and illustration, rather than of limitation. Changes may be made within the scope of the appended claims, as presently stated and as amended, without departing from the scope and spirit of optimizing interventional procedures in their aspects. Although developing adaptive predictive analytics has been described with reference to particular means, materials, and embodiments, developing adaptive predictive analytics is not intended to be limited to the details disclosed, but rather extends to all functionally equivalent structures, methods, and uses, as fall within the scope of the appended claims.

[0047] The descriptions of representative embodiments described herein are intended to provide a general understanding of the structure of various embodiments. The figures are not intended to serve as a complete description of all of the elements and features of the present disclosure described herein. Many other embodiments will be apparent to those skilled in the art upon review of the present disclosure. Other embodiments can be utilized and derived from the present disclosure, such that structural and logical substitutions and changes are made without departing from the scope of the present disclosure. Additionally, the figures are merely representational and may not be drawn to scale. Some proportions within the figures have been exaggerated, while others have been minimized. Accordingly, the present disclosure and the figures should be considered illustrative and not limiting.

[0048] Although specific embodiments have been illustrated and described herein, it should be understood that any subsequent constructions designed to achieve the same or similar purpose may be substituted for the specific embodiment shown. The present disclosure is intended to cover any and all subsequent adaptations or variations of the various embodiments. Combinations of the above embodiments, as well as other embodiments not specifically described herein, will be apparent to those skilled in the art upon reviewing this description.

[0049] The Abstract of the Disclosure is provided for purposes of compliance with 37 CFR §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. Moreover, 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 features of any disclosed embodiment. Accordingly, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as defining separately claimed subject matter.

[0050] The foregoing description of the disclosed embodiments is provided to enable any person skilled in the art to practice the concepts described in this disclosure. Accordingly, the above disclosed subject matter should be considered as illustrative and not limiting, and the appended claims are intended to encompass all such modifications, enhancements, and other embodiments that fall within the true spirit and scope of the present disclosure. Accordingly, to the maximum extent permitted by law, the scope of the present disclosure should be determined by the broadest permissible interpretation of the following claims and their equivalents, and should not be limited or restricted by the detailed description set forth above.

Claims

1. 1. A method for ensuring that a medical connector of a device is disinfected or sterilized, the method comprising: receiving the medical connector in a blocked state in which a component of the medical connector having a shape memory alloy is deformed so that the medical connector cannot engage with a mating connector; and heating the medical connector to a temperature sufficient to change the shape of the shape memory alloy, thereby reforming the component and rendering the medical connector unblocked and capable of engaging with the mating connector; A method comprising:

2. The method of claim 1 , wherein the shape memory alloy transforms to the blocked state upon removal of the medical connector from the mating connector.

3. 2. The method of claim 1, wherein the shape memory alloy is disposed in a structure surrounding a pin of the medical connector, and is transformed to the blocked state when the medical connector is removed from a mating connector.

4. 2. The method of claim 1, wherein the medical connector includes an electrical shielding electrode having the shape memory alloy, the electrical shielding electrode transforming to the blocked state upon removal of the medical connector from the mating connector.

5. 5. The method of claim 4, wherein the medical connector is returned to the unblocked state by heating the shape memory alloy of the medical connector to a temperature sufficient to change the shape of the electrical shielding electrode.

6. 10. The method of claim 1, wherein the temperature is 65°C or greater.

7. 10. The method of claim 1, wherein the temperature is in the range of 120°C to 135°C.

8. 10. The method of claim 1, wherein the shape memory alloy comprises one of Ag—Cd, Au—Cd, Cu—Al—Ni, Cu—Sn, Cu—Zn-(X), In—Ti, Ni—Al, Ni—Ti, Fe—Pt, Mn—Cu, and Fe—Mn—Si alloys.

9. 1. A medical device having a medical connector having a shape memory alloy adapted to engage with a mating connector in an unblocked state, When the medical connector is disengaged, the shape memory alloy is in a blocked state so that the medical connector cannot engage with the mating connector, and the shape memory alloy is configured to change shape when the medical connector is heated to a temperature sufficient to allow the medical connector to engage with the mating connector. Medical devices.

10. The medical device of claim 9 , wherein disengaging the medical connector transforms the shape memory alloy to the blocked state.

11. 10. The medical device of claim 9, wherein the medical connector has an electrical shielding electrode having the shape memory alloy, the electrical shielding electrode transforming to the blocked state when the medical connector is detached from a mating connector.

12. 12. The medical device of claim 11, wherein the medical connector is returned to the unblocked state by heating the shape memory alloy of the medical connector to a temperature sufficient to change the shape of the electrical shielding electrode.

13. The medical device of claim 9 , wherein the temperature is 65° C. or higher.

14. The medical device of claim 9, wherein the temperature is in the range of 120°C to 135°C.

15. 10. The medical device of claim 9, wherein the shape memory alloy comprises one of Ag-Cd, Au-Cd, Cu-Al-Ni, Cu-Sn, Cu-Zn-(X), In-Ti, Ni-Al, Ni-Ti, Fe-Pt, Mn-Cu, and Fe-Mn-Si alloys.

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