Linear Element Securing System and Method of Use

FIELD

[0001] The subject matter herein generally relates to a system for securing items to a patient, such as linear elements, cannulas, intravenous linear elements, and/or cables with additional available capabilities and a method of using the system.

BACKGROUND

[0002] Many medical conditions cause hypoxemia (lower than normal levels of dissolved oxygen in the blood), including lung infections, chronic obstructive pulmonary disease, pulmonary emboli, pulmonary edema, inherited disorders, and many others. Prolonged hypoxemia, if untreated, will cause significant harm to a patient, including both the unpleasant subjective sensation of shortness of breath as well as organ damage and, ultimately, death. Hypoxemia is treated in part by supplying the patient with supplemental oxygen to raise blood oxygen levels to within a normal range. Supplemental oxygen, in many instances - both in ambulatory and acute care settings - is delivered to the patient by a nasal cannula that is inserted into the patient’s nostrils and then draped over the patient’s ears. Like any medical treatment, the ‘dose’ of oxygen delivered to the patient needs to be carefully monitored and titrated. This is often done by monitoring a surrogate marker of a patient’s blood oxygen levels via transcutaneous pulse oximeter and then titrating the liter per minute flow of oxygen and/or the oxygen concentration being delivered to the patient to obtain the desired pulse oximeter reading. [0003] In the medical field, the use of cannulas is often used to deliver oxygen to patients. As mentioned above, the cannula is draped over the ears of the patient. While the patient is in a stable position and upright, the routing of the cannula over the ears helps to keep the nose prongs in place. However, there are many instances where the patient is not in a stable position and upright, often resulting in displacement of the nose prongs and inadequate delivery of oxygen to the patient. For instance, this often occurs during sleep. In acutely ill patients with delirium or patients with dementia, they often unknowingly or inappropriately remove or move the oxygen cannula resulting in inadequate oxygen delivery.

BRIEF DESCRIPTION OF THE DRAWINGS

[0004] Implementations of the present technology will now be described, by way of example only, with reference to the attached figures, wherein:

[0005] FIG. 1 shows an embodiment of a linear element support system on a patient.

[0006] FIG. 2 shows an embodiment of a linear element support device.

[0007] FIG. 3 shows an embodiment of a linear element support device.

[0008] FIG. 4 shows an embodiment of a linear element support system on a patient.

[0009] FIG. 5 shows an embodiment of a linear element support device.

[0010] FIG. 6 shows an embodiment of a linear element support device.

[0011] FIG. 7 shows an embodiment of a linear element support system on a patient.

[0012] FIG. 8 shows an embodiment of a linear element support system on a patient.

[0013] FIG. 9 shows an embodiment of a nasal prong attachment.

[0014] FIG. 10 shows an embodiment of a nasal prong attachment. DETAILED DESCRIPTION

[0015] It will be appreciated that for simplicity and clarity of illustration, where appropriate, reference numerals have been repeated among the different figures to indicate corresponding or analogous elements. In addition, numerous specific details are set forth in order to provide a thorough understanding of the embodiments described herein. However, it will be understood by those of ordinary skill in the art that the embodiments described herein can be practiced without these specific details. In other instances, methods, procedures, and components have not been described in detail so as not to obscure the related relevant feature being described. The drawings are not necessarily to scale, and the proportions of certain parts may be exaggerated to better illustrate details and features. The description is not to be considered as limiting the scope of the embodiments described herein. It should be noted that references to embodiments (e.g., “an,” “one,” “some”) in this disclosure are not necessarily to the same embodiment, and such references mean at least one.

[0016] Several definitions that apply throughout this disclosure will now be presented. [0017] The term “coupled” is defined as connected, whether directly or indirectly, through intervening components and is not necessarily limited to physical connections. The connection can be such that the objects are permanently connected or releasably connected. The term “electrically coupled” is defined as being in structural, electrical contact, whether directly or indirectly through intervening components, to allow the flow of electrons between the respective elements. The term “outside” refers to a region that is beyond the outermost confines of a physical object. The term “inside” indicates that at least a portion of a region is partially contained within a boundary formed by the object. The term “about” in relation to quantitative measurements (unless otherwise stated) includes, but is not limited to, the disclosed measure and measurements about the disclosed measure in terms of its disclosed degree. For example, “about 90” would at least include 80-100, whereas “about 90.0” would at least include 89.0-91.0. The term “comprising” means “including, but not necessarily limited to”; it specifically indicates open-ended inclusion or membership in a so-described combination, group, series, and the like. The term “substantially” is defined to be essentially conforming to the particular dimension, shape or other word that substantially modifies, such that the component need not be exact. For example, substantially cylindrical means that the object resembles a cylinder, but can have one or more deviations from a true cylinder.

[0018] Current methods to deliver oxygen to a patient and to measure a patient’s pulse oximeter levels have several limitations that result in both patient dissatisfaction as well as medically dangerous situations: i) nasal cannula tubing often becomes displaced from the patient resulting in inadequate oxygen delivery (e.g., the patient is sleeping and unknowingly moves tubing or a patient with delirium pulls at tubing). Furthermore, there generally is not an automatic way to notify a patient or caregiver that the oxygen is no longer being delivered appropriately, resulting in a potentially prolonged hypoxemic state before being recognized. ii) continuous oxygen monitoring is typically done using a finger pulse oximeter, which itself often falls off the patient or gives poor readings due to changes in positioning. Furthermore, this device interferes with the patient’s ability to use that finger for other tasks. iii) the delivery of oxygen via nasal cannula and the monitoring of pulse oximeter oxygen levels are individually monitored and adjusted manually by either the patient or those monitoring the patient. This requires frequent checking and adjustment to ensure minute-to-minute accurate titration of oxygen levels to the patient’s needs (too much or too little) and often results in inappropriate oxygen dosing for prolonged periods of time.

[0019] The present disclosure is described in relation to the use of the linear element support system 1000 in the delivery of supplemental oxygen wherein the linear element 300 is a cannula; however, it is to be understood that the linear element support device 1 can be used for any item that needs to be routed or secured to or near a patient and/or monitoring provided.

Examples of items that can be a linear element 300 are, but not limited to tubing, wires, lines, IVs, catheters, monitors, devices, leads, cannulas, and drains. Also, while described as securing tubing, it is to be understood that cables or other linear elements can also be secured.

Embodiments of the linear element support system 1000 can be very beneficial if a patient has a condition in which a linear element 300 is not able to be draped over one or two ears (e.g., missing an ear) or needs to be secured to or near a patient.

[0020] FIG. 1 illustrates an embodiment of the linear element support system 1000 comprising a linear element 300 and a linear element support device 1 in use on a patient. In some embodiments, the linear element 300 comprises nasal prongs 301 that are configured to extend inside the nasal cavities of a patient, as shown. The linear element 300 can extend along both sides of the patient’s head and drape over each ear.

[0021] FIG. 2 illustrates an embodiment of the linear element support device 1. In some embodiments, the linear element support device 1 comprises a first member 2 and a second member 3 that are coupled together. In some embodiments, the first member 2 comprises a securing member 22 and a first member engagement area 21. In some embodiments, the second member 3 comprises a second member engagement area 31 and a second member actuation section 32. In some embodiments, the first member 2 and the second member 3 are coupled together by a connection 6. In some embodiments, the securing element 220 is a part of the first member 2, and in some embodiments, the securing element 220 is a part of the second member 3.

[0022] In some embodiments, the securing member 22 comprises one or more securing elements 220. In some embodiments, each securing element 220 comprises a retaining element 221 that defines a retaining opening 222. In some embodiments, in some embodiments, the inside of each securing element 220 substantially corresponds to the linear element 300. In some embodiments, the inside of each securing element 220 can be sized such that there is an interference fit between the securing element 220 and a predetermined linear element 300 to prevent all linear movement or limit linear movement along the length of the linear element 300 once secured. In some embodiments, the inside of each securing element 220 can be sized such that linear movement is freely allowed between predetermined linear element 300 and the securing element 220 along at least a portion of the length of the linear element 300. In some embodiments, the retaining opening(s) 222 is sized such that the outside of a predetermined linear element 300 can be inserted with though retaining opening(s) 222. In some embodiments, the predetermined linear element 300 is deformed when inserted into one or more retaining openings 222. In some embodiments, the linear element 300 is deformed when being inserted through the one or more retaining openings 222 but allowed to expand inside once inside each retaining element 221.

[0023] In some embodiments the linear element support system comprises one or more sensors. In some embodiments, the linear element support device 1 comprises a blood oxygen sensor 5 on, inside, outside, or a combination thereof, the first member 2 and/or the second member 3. In some embodiments, the blood oxygen sensor 5 can be transmissive pulse oximetry type, which would require a part, or parts thereof, of the blood oxygen sensor 5 to be located on, be part of, coupled to, or a combination thereof, both the first member 2 and the second member 3, or a reflectance pulse oximetry, which can be located on, be part of, coupled to, or a combination thereof, either the first member 2 or the second member 3. In some embodiments, blood oxygen sensor 5 on, inside, outside, or a combination thereof the first member engagement area 21 and/or the second member engagement area 31. In some embodiments, the linear element support system 1000 will produce a linear support system response if the readings from the blood oxygen sensor 5 is not within predetermined parameters (e.g., readings too low, readings too low over a certain amount of time). In some embodiments, the linear element support system response comprises an alarm (e.g., visual, auditory), notification, signal, display a warning, sending a signal to other devices, adjust (or cause the adjustment of) the flow of fluid in the linear member, or a combination thereof.

[0024] In some embodiments, the connection 6 comprises a pin 61 that connects the first member 2 and the second member 3. In some embodiments, the connection 6 comprises a spring 62. In some embodiments, spring 62 is integral with the first member 2, the second member 3, or both. In some embodiments, the spring 62 is located about the pin 61. The spring 62 will bias the first member engagement area 21 and the second member engagement area 31 toward each other. In some embodiments, the connection 6 will comprise a rotational block (not shown) that prevents the first member engagement area 21 and the second member engagement area 31 from coming in contact with each other, applying too much pressure, and/or maintaining at least a preset distance apart. In some embodiments, the rotational block is elastic.

[0025] FIG. 3 illustrates an embodiment of the linear element support device 1. In some embodiments, the linear element support device 1 comprises an electronics module 223. In some embodiments, the electronics module 223 is located on, inside, outside, coupled to, or a combination thereof, the first member 2 and/or the second member 3. In some embodiments, the electronics module 223 comprises wireless connection capabilities; power; batteries; hardwiring connections, inlets, and/or outlets (e.g., power, ethemet, HDMI); display; or a combination thereof.

[0026] FIG. 4 illustrates an embodiment of the linear element support system 1000 comprising an embodiment of the linear element support device 1 securing a linear element 300 to a patient. In some embodiments, the securing member 22 can comprise multiple securing elements 220. In some embodiments, the multiple securing elements 220 are in line with each other, and in some embodiments, at least one of the securing elements 220 is not in line with one or more of the other securing elements 220.

[0027] FIG. 5 illustrates an embodiment of the linear element support device 1. In some embodiments, the first member 2 comprises an extension 23. In some embodiments, the extension 23 extends along a direction that creates an angle, as compared to the second member, greater than zero degrees (0°). In some embodiments, the angle is, or about, nighty degrees (90°). In some embodiments, the securing member 22 comprises two more securing elements 220. In some embodiments, two or more securing elements 220 are located on the extension 23. In some embodiments that comprise two or more securing elements 220, the retaining openings 222 alternate the direction in which the linear element 300 enters into the securing elements 220, which can provide a more secured connection. As indicated above, in embodiments that comprise two or more securing elements 220, they are not linearly aligned, while in some embodiments, they are.

[0028] In some embodiments, the first member 2 is planar. In some embodiments, the securing member 22 is located on a surface of the first member 2. In some embodiments, the securing member 22 comprises one or more securing elements 220 located on a surface of the first member 2 that faces away from the second member 3. In some embodiments, the one or more securing elements 220 are located on a surface of the first member 2 that faces the second member 3.

[0029] Further, FIGs 1 and 4 are shown having the first member engagement area 21 engaging the front face of the ear and the second member engagement area 31 engaging the rear face of the ear. However, it is to be understood that the linear element support device 1 can be placed such that the first member engagement area 21 engages the rear surface of the ear and the second member engagement area 31 engages the front surface of the ear.

[0030] FIG. 6 illustrates an embodiment of the linear element support device 1 comprising an electronics module 223. In some embodiments, there are multiple electronics modules 223. In some embodiments, the electronics module 223 is located on, inside, outside, coupled to, or a combination thereof, the extension 23. [0031] FIG. 7 illustrates an embodiment of the linear element support system 1000 wherein the linear element support device 1 is integral with and/or permanently coupled to the linear element 300, and the linear element 300 is a part of the linear element support system 1000. In some embodiments, linear element support device 1 will comprise a sensor that will enable the measure the flow of the fluid flowing through the linear element 300. In some embodiments, the sensor will enable the measurement of the pressure of the fluid flowing through the linear element 300. It is to be understood that the term fluid, includes, but is not limited to fluids, gasses (e.g., oxygen, air), or a combination thereof. In some embodiments, the sensor will enable the detection and/or measurement of back pressure created by an exhale of the user. In some embodiments, if backpressure is not sensed and/or not sensed to a certain level within one or more parameters (e.g., within a specified time frame), the linear element support system 1000 will initiate a linear element support system response. In some embodiments, the sensor is located on, inside, outside, coupled to, or a combination thereof, the linear element 300 and/or linear element support device 1.

[0032] FIG. 7 also illustrates an embodiment that employs the use of a nasal prong attachment 7. In some embodiments, the nasal prong attachment 7 can be an integral part of the linear element 300. In some other embodiments, the nasal prong attachment 7 is a separate element that can be coupled to one or both the nasal prongs 301. In some embodiments, one of the sensors of the linear element support system 1000 is a nasal prong sensor 722 comprise a sensor that will enable the measure the flow of the fluid flowing out, in, and/or the about the linear element 300 and/or one or more of the nasal prongs 301. In some embodiments, the nasal prong sensor 722 is part of the nasal prong attachment 7. In some embodiments, the nasal prong sensor 722 will enable the measurement of the pressure of the fluid flowing through the linear element 300. In some embodiments, the nasal prong sensor 722 will enable the detection and/or measurement of back pressure (or pressure) created by an exhale by the user in the one or more nasal prongs 301, the linear element 300, outside the one or more of the nasal prongs 301, or a combination thereof. In some embodiments, the nasal prong sensor 722 is in communication with linear element support device 1 and/or another device. In some embodiments, the nasal prong sensor 722 is located on, inside, outside, coupled to, or a combination thereof, the nasal prong attachment 7 and/or one or both of the nasal prongs 301. It is to be understood that the nasal prong attachment 7 can be part of the linear element support system 1000 or can be used independently thereof. In some embodiments, the nasal prong sensor 722 can initiate, or create, the linear element support system response.

[0033] FIG. 8 illustrates an embodiment of the linear element support system 1000 wherein the nasal prong attachment 7 is electrically coupled to the linear element support device 1 via a conduit 8. In some embodiments, the conduit 8 is a wire. In some embodiments, the conduit 8 is integral with the linear element 300.

[0034] FIG. 9 illustrates an embodiment of a nasal prong attachment 7 comprising a plug 71. The plug 71 can help establish a more secure fit of the nasal prongs 301 inside the nasal passages. In some embodiments, there are two plugs 71. In some embodiments, one or more of the plugs 71 define plug holes 711 that will allow for atmospheric air to be drawn in through the nose as well as the fluid supplied by the linear element 300. In some embodiments, the one or more plugs 71 are integral with the linear element 300, and in other embodiments, the one or more plugs 71 are configured to attach to, or outside, the nasal prongs 301. In some embodiments, the one or more plugs 71 and the nasal prongs 301 are secured to each other by an interference fit. In some embodiments, the one or more plugs are integral with one or more nasal prong. In some embodiments, the one or more plugs 71 are made of a flexible material, and in some embodiments, the flexible material is more flexible than the linear element 300. In some embodiments, the one or more plugs 71 are made of an elastomer. In some embodiments, the plugs 71 are coupled together. In some embodiments, nasal prong sensor 722 is located on, inside, outside, coupled to, or a combination thereof, the plug 71 and/or the one or more nasal prongs 301.

[0035] FIG. 10 illustrates an embodiment of a nasal prong attachment 7 comprising a fitting 72. The fitting 72 comprises one or more shafts 721 that fit over the one or more nasal prongs 301. In some embodiments, the fitting 72 comprises a nasal prong sensor 722. In some embodiments, a fitting bridge 723 extends from one shaft 721 to another shaft 721. In some embodiments, the fitting 72 is integral with the linear element 300. In some embodiments, the fitting 72 is a separate element that is configured to attach to a linear element 300. In some embodiments, the fitting 72 and the linear element 300 are coupled to each other by an interference fit. In some embodiments, the fitting 72 comprises a clip (not shown) that engages the nasal prong conduit 302. In some embodiments, the clip at least partially encircles at least a portion of the nasal prong conduit 302. In some embodiments, the fitting bridge 723 comprises the clip that engages the nasal prong conduit 302. In some embodiments, when the fitting 72 is attached to the linear element 300, the nasal prongs 301 extend past the one or more shafts 721. In some embodiments, the fitting 72 is integral with the linear element 300. In some embodiments, the shafts 721 are the nasal prongs 301. In some embodiments, nasal prong sensor 722 is located on, inside, outside, coupled to, or a combination thereof, the fitting 72 and/or the one or more nasal prongs 301.

[0036] In some embodiments, nasal prong sensor 722 is located on, inside, outside, coupled to, or a combination thereof, the nasal prong attachment 7 and/or the one or more nasal prongs 301.

[0037] In some embodiments, the linear element support system 1000, and many of the embodiments described herein, are provided as a kit to be applied to a linear element 300.

[0038] In some embodiments, the linear element support system 1000 is configured to adjust and/or control the flow of oxygen though the linear element 300 and/or direct other devices to adjust and/or control the flow of oxygen though the linear element 300.

[0039] The methods are provided by way of example, as there are a variety of ways to carry out the method. The methods described below can be carried out using the configurations illustrated in FIGS. 1 through 10, for example, and various elements of these figures are referenced in explaining example methods. Further, methods can also be derived from the disclosure above and are disclosed as methods for using and actions of the linear element support system 1000. The order of steps is illustrative only, and the order of the steps can change according to the present disclosure. Additional steps can be added, or fewer blocks may be utilized without departing from this disclosure.

[0040] In some embodiments, a method comprises:

A. providing a linear element 300 and a linear element support system 1000, wherein the linear element support system 1000 comprises a linear element support device 1, and the linear element support device 1 comprises a securing member 22. B. securing the securing member 22 to a portion of the linear element 300.

C. attaching the linear element support device 1 to a patient’s ear.

[0041] In some embodiments, the method comprises:

A. providing a linear element 300 and a linear element support system 1000, wherein the linear element support system 1000 comprises a linear element support device 1, and the linear element support device 1 comprises a securing member 22.

B. securing the securing member 22 to a portion of the linear element 300.

C. attaching the linear element support device 1 to a material.

[0042] In some embodiments, the method comprises:

A. providing a linear element 300 and a linear element support system 1000, wherein the linear element support system 1000 comprises a linear element support device 1, and the linear element support device 1 comprises a securing member 22 and a blood oxygen sensor 5.

B. securing the at least one retaining element 221 to a portion of the linear element 300.

C. attaching the linear element support device 1 the patient such that the blood oxygen sensor 5 is able to measure the blood oxygen of the patient.

[0043] In some embodiments, the method comprises:

A. a linear element support system 1000, wherein the linear element support system 1000 comprises a linear element support device 1 and a linear element 300, and the linear element support device 1 comprises a securing member 22 and a blood oxygen sensor 5. B. securing the linear element 300 to the linear element support device 1, wherein the securing the linear element 300 comprises coupling the linear element 300 to the securing member 22.

C. obtaining readings from one or more sensors.

E. initiating a linear element support system response.

[0044] In some embodiments, one of the one or more sensors is a configured to obtain a blood oxygen reading, and initiating the linear element support system response comprises adjusting the flow of oxygen in the linear element 300 in response to the blood oxygen sensor 5 measurements.

[0045] In some embodiments, a method comprises pressing on the second member actuation section 32 to actuate the linear element support device 1.

[0046] In some embodiments, a method comprises connecting the linear element support device 1 to Wi-Fi and/or an auxiliary device.

[0047] In some embodiments, a method comprises adjusting the linear element 300 and/or the linear element support device 1 in reaction to a linear element support system response from the linear element support system 1000. In some embodiments, the linear element support system 1000 will produce a linear element support system response.

[0048] Some embodiments of a method comprise attaching a nasal prong attachment 7 to a nasal prong 301. In some embodiments, the nasal prong attachment 7 comprises a one or two plugs 71, and the plugs 71 are inserted into a nasal cavity and have an interference fit therewith.

In some embodiments, one or two plugs 71 are inserted into and placed in an interference fit with the nasal cavity. In some embodiments, the nasal prong attachment 7 comprises a fitting 72, and the fitting 72 is attached to the linear element 300. In some embodiments of a method comprise electrically coupling the nasal prong attachment 7 to the linear element support device 1. In some embodiments, a method comprises placing the nasal prong attachment 7 in communication with an auxiliary device.

[0049] In some embodiments, a user will place nasal prongs 301 inside the nose of a patient and can position part of the linear element 300 around the ears. The first member engagement area 21 and the second member engagement area 31 can be attached to the earlobe (as seen in FIG 1), the helix (as seen in FIG 4), the antihelix, or any part of the outer ear where the linear element support device 1 can attach. It is to be understood that linear element support device 1 can be used on a patient (e.g., one on each ear) or more as needed.

[0050] However, some patients may not have an ear that is able to have a linear element 300 draped about it or may not have an ear at all. It is to be understood that the linear element 300, or any item retained by the linear element support device 1, need not be routed around the ear. The linear element support device 1 will be clipped to the patient’s ear or an item attached to the patient (e.g., gown). It is also understood that the linear element support device 1 device can be attached to other parts of the patient, patient’s clothes, or other articles (e.g., bed sheets).

[0051] It is also to be understood that if using an embodiment comprising a blood oxygen sensor 5, because of a desire to measure the blood oxygen content, only linear element support device 1 need to be used, while an embodiment without a blood oxygen sensor 5 can be used on the other ear. However, there is nothing to prevent the use of linear element support device 1, comprising a blood oxygen sensor 5 to be used on both ears. [0052] The embodiments described herein address some, or all, of the above issues by describing a device and system that secures linear element 300 tubing to a patient more effectively, removes the need to monitor pulse oximetry levels on a patient’s finger, and/or contains a closed-loop system that can auto-titrate oxygen levels based on real-time pulse oximeter readings as well as transmit and store that data.

[0053] The embodiments shown and described above are only examples. Even though numerous characteristics and advantages of the present technology have been set forth in the foregoing description, together with details of the structure and function of the present disclosure, the disclosure is illustrative only, and changes may be made in detail, including in matters of shape, size and arrangement of the parts within the principles of the present disclosure up to, and including, the full extent established by the broad general meaning of the terms used in the claims.

[0054] It should also be noted that elements of embodiments may be described in reference to the description of a particular embodiment; however, it is disclosed that elements of disclosed embodiments can be switched with corresponding elements of embodiments with the same name and/or number of other disclosed embodiments.

[0055] Depending on the embodiment, certain steps of methods described may be removed, others may be added, and the sequence of steps may be altered. It is also to be understood that the description and the claims drawn to a method may include some indication in reference to certain steps. However, the indication used is only to be viewed for identification purposes and not as a suggestion as to an order for the steps.